Minutes of 289th Meeting of Registration Board PDF

MINUTES OF 289 th MEETING OF REGISTRATION BOARD
HELD ON 14 th-16th MAY, 2019
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Item No. Detail of Item Pages

I. Confirmation of Minutes of 288th Meeting of Registration Board 03
II. Cases referred by Members Registration Board 04 – 07
III. Division of Pharmaceutical Evaluation & Registration 21 – 1402
 Pharmaceutical Evaluation Cell (PEC) ...................... ......... 21–1118

 Registration-I ............. .................. ..................... ................ 1119–1182
 Registration-II .............. .................. .................. ................. 1183–1187
 Import & Vet. – I .................. .................. .................. ......... 1188–1209
 Import & Vet. – II .................. ..................... .................... ... 1210–1229
 Post Registration-I .................. ................... .................. ..... 1230–1262
 Post Registration-II .................. ...................... ................ .. 1263–1271
 RRR Section ................. ................ .................. ............. ..... 1272–1402
IV. Division of Biological Evaluation & Research 1403 – 1427

V. Division of Quality Assurance & Laboratory Testing 1428 – 1455
VI. Additional Agenda 1456 – 1525
A. Biological Evaluation & Research ...................................... 1456 – 1477

B. Pharmaceutical Evaluation & Registration ......................... 1478 – 1501
C. I&V – I Section ...................... ..................... .............. ........ 1502 – 1520
D. I&V –II Section .............. .................... ................ .............. 1521 – 1525
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4
Islamabad.
Minutes of 289th Meeting of Registration Board (14-16 May, 2019) |1

289th meeting of Registration Board was held on 14–16th May, 2019 in the committee
room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Dr.Obaidullah, Director, Pharmaceutical Evaluation & Registration Division, DRAP. The
meeting started with recitation of the Holy Verses. The meeting was attended by following: -
1. Dr. Rafeeq Alam Khan Member
Meritorious Professor Dean, Faculty of Pharmacy,
Zia-ud-Din Univeristy. (Pharmacologist)
2. Maj.Gen. Dr. Tahir Mukhtar Sayed. Member
Director General Medicine, Pak Army, Rawalpindi. (Physician)
3. Prof.Dr.Ghulam Sarwar. Member
Dean,Faculty of Pharmacy, Jinnah University for Women, Karachi
(Expert in Drug Manufacturing)
4. Dr.Aslam Shah, Senior Manager, Member
Indus Hospital, Karachi (Expert in Hospital Pharmacy)
5. Dr.Qurban Ali, ex-Director General, Member
National Veterinary Laboratory (Expert in Veterinary Medicine)
6. Dr. Amanullah Khan, Member
Director, Drugs Testing Laboratory, Quetta
Government of Balochistan/ Provincial Member
7. Dr. Muhammad Khalid Javaid, Member
Director, Drugs Testing Laboratory, Peshawar
Government of Khyber Pakhtunkhwa/ Provincial Member
8. Mr.Abid Saeed Baig, Director, Drugs Testing Laboratory, Rawalpindi Member
Dr. Shafiq ur Rehman, Director, Drugs Testing Laboratory, Lahore
Government of Punjab/ Provincial Member
9. Syed Adnan Rizvi, Member
Director, Drugs Testing Laboratory, Karachi
Government of Sindh/ Provincial Member
10. Mr. Muhammad Aslam, Member
Assistant Draftsman-II, Ministry of Law & Justice, Islamabad
11. Mr.Ghulam Mujtaba
Representative of IPO
12. Dr. Noor-us-Saba Member
Director, Biological Evaluation & Research Division, DRAP
13. Dr. Hafsa Karam Ellahi, Additional Director, Member
Representative of QA&LT Division, DRAP
14. Dr. Muhammad Akram, Represntative of Animal Husbandry Co-opted
Commissioner, M/o National Food Security & Research. Member
15. Mr. Abdullah, Member/
Additional Director (PE&R), DRAP. Secretary
Ms.Tahreem Sara (Dy.Director,RRR), Mr. Asif Jalil, Incharge PEC and respective
Assistant Directors, presented the agenda of PE&R Division. Director, BE&R assisted by
respective Assistant Directors, presented the agenda of Biological Evaluation & Research
Division. Dr. Hafsa Karam Ellahi (Additional Director, QA&LT) assisted by respective Assistant
Director, presented the agenda of QA & LT Division.
Mr. Shamim Ahmad, Mr. Hamid Raza, Mr. Arshad Mehmood (PPMA), Mr.Rashid
Mureed & Mr. Nadeem Alamgeer (Pharma Bureau) and Mr. M.Asad Malik (PCDA) attended the
meeting as observers.
Item No. I: Confirmation of Minutes of 288th Meeting of Registration Board.
288th meeting of Registration Board was held on 14 th to 15th February 2019. The draft
minutes of 288th meeting of Registration Board were circulated among the members of
the meeting on 18th March, 2019 with the request to forward their comments (if any)
within five days. None of the members disagreed the draft minutes. Accordingly, minutes
were approved by the Chairman Registration Board and circulated
to all concerned.
Decision: Registration Board confirmed minutes of 288 th meeting.

Item No. II: Cases Referred by Members of Registration Board.
A. Dr. Amanullah Khan, Director DTL, Quetta.

1. Email of May 3, 2019
Comment Response
As earlier through email and during various meetings I have pointed out my Matter has already
serious concern over the way the panels are constituted for inspection within been deliberated at
the country and outside the country because such panels are not acceptable to length and decided
me because to me it‘s violation of the law as the panels for inspection are not in 286th meeting
approved by the board rather it is constituted by only one individual which is Registration Board
based by personal pick and choose and is against the teachings of our Prophet held on 14-16th
Hazarat Muhammad (P.B.U.H). Therefore across the board all those November, 2018.
Inspection‘s which are done or going to be done without the approval of the
Registration Board for me they are not Approved. In the each decision of the
panel inspection my note of dissent shall be added and read as not Approved
2. Email of January 26, 2018

a. Biological Drugs Registration.
It is submitted with great concerned that in my opinion the Biological Division has few very
important issues which relates with the working capacity of the division and other issues related
with DRAP and Board.
a. Biological Drugs Registration:

S.No. Comment Response
1. It is submitted with great concerned Reply of DBER:
that in my opinion the Biological 1.1 The working in the DBER has improved tremendously after
Division has few very important the appointment of permanent Director with relevant experience
issues which relates with the which has been duly acknowledged by Dr. Amanullah on
working capacity of the division different occasions.
and other issues related with DRAP 1.2 Biological Drug is a highly specialized rapidly evolving
and Board. subject; therefore the DRAP Policy Board in its first meeting in
2013 had rightly approved the formation of a separate
registration board. This decision has been acknowledged by the
present Registration Board many times. When this decision is
implemented the Biological Drugs Board will engage the
relevant experts in the field of oncology, vaccinology,
hematology, endocrinology, virology, bacteriology,
biotechnology, epidemiology, biotechnology quality control
and manufacturing expertise etc. for both human and veterinary
biological drugs.
1.3 In DRAP fresh 100 Assistant Directors were recruited who
are still undergoing trainings for evaluation of dossiers,
majority have no relevant experience in manufacturing or
quality control of drugs let alone biological drugs.
1.4 It takes years of teaching to become knowledgeable in the
field of biological drugs as this subject is not taught in practical
terms in any university or college of our country at graduate of
masters level. Initially 09 Asst. Directors were appointed in
DBER. Out of which 04 were latter on transferred to NCLB and
01 was transferred to CDL, Karachi. The 04 transferred to
NCLB were later on transferred to Health & OTC Division
which were then transferred to other divisions. Out of
remaining 04 Asst. Directors, 01 was recently transferred to
Pharmaceutical Evaluation Cell after working in DBER for

more than two years. All this is happening without the consent
of Director DBER who is currently working with only 03 Asst.
Directors instead of full strength.
1.5 Now, the renewal cases are also being referred to Biological
drugs from RRR section and due to work load and less human
resource the timely processing of renewal applications is
becoming really difficult.
1.5. Despite such work load and limited human resource the
Biological Drugs Division has no pendency of new registration
applications and is able to achieve many mile stones shown
below.
Further deliberations in Registration Board:
For constitution of separate Board for Biological drugs, the
Board advised to process case at appropriate forum.
Appropraite distribution of human resource is primalrily
function and responsibility of the management of an
organization. It would be appropriate that Biological Division
may process case keeping in view existing workload of present
officers and upcoming/ pending work to DRAP‘s management
for suitable decision.
2. The present staff is inexperienced Reply of DBER:
due to which the biological 2.1 In DRAP over 100 fresh Assistant Directors were recruited
product(s) case(s) are not properly who are still undergoing trainings for evaluation of dossiers,
presented before the registration majority have no relevant experience in manufacturing or
board. quality control of drugs let alone biological drugs.
2.2 The cases are presented on approved format if there is any
deficiency in the format the Board may review the pattern.
2.3As noted by Dr. Amanullah in previous meetings the
working has improved after the appointment of permanent
Director with relevant experience in vaccinology.
2.4 The incumbent Director being the only experienced person
in the relevant field with this new staff has managed to achieve
the following during the past one year:
a. Developed the biosimilarity guidelines for registration of
imported biotherapeutic products.
b. Developed the biosimilarity guidelines for registration of
locally biotherapeutic products.
c. Developed the guidelines for registration of imported
Enoxaparin Injections.
d. Developed the guidelines for registration of locally
manufactured Enoxaparin Injections.
e. Processed the registration applications which were pending
since 2013.
2.5. Moreover, it is evident by comparing the agenda of recent
meetings with previous meetings that all the important
information e.g. Biosimilarity studies, stability studies etc. as
required by the Registration Board is included in the agenda of
meeting.
2.6Further, now every registration application is being
evaluated as per checklist of Form-5 or Form-5A and the
checklists are attached with the applications or office files as
permanent record of evaluation report while previously that was
not the practice.
2.7. As compared to other drugs the Biological Drugs
applications are already submitted on CTD dossiers for the past
many years. This format is now being adopted for other drugs
as well and after uniform assessment the Board will be able to

judge all drugs on same criteria thus avoiding the present two
systems of applications.
Registration Board considers abd decide the applications in
light of available data and status of the product / formulation in
reference regulatory authorities. If any case is deficient in any
information / data, then such applications are deferred for
having required data.
3. After the resignation by the Reply of DBER:
biological member from the 3.1 The Biological Drugs Division has already forwarded the
registration board and to date no file for nomination of another expert on 05-05-2017. The
replacement of the biological nomination is still pending.
member by the DRAP is done and 3.2 However, currently Dr. Qurban Ali and Maj. Gen. Tahir
it is one of the factor that the Mukhtar Sayed are the biological expert but it seems that Dr.
registration board has some Amanullah is not satisfied with their contribution. It is further
difficulty in the grant of registration clarified that both of these members were fully involved in the
for biological products, so there is development of above guidelines.
immediate need to nominate 3.3 Moreover, Directors of pharmaceutical Drug Testing
biological expert/ member so the Laboratories are the members of the Board while the relevant
registration of the biological Director NCLB which is responsible for the Lot release of
products becomes smooth. Biological Drugs is not the member of the Board it is once
again submitted that Director NCLB should be part of the DRB
on permanent basis.
Point at 3.2 above was refuted by Director DTL, Quetta and
other members of Registration Board.
4. Unfortunately non-technical Reply of DBER:
persons are nominated in the panel 4.1 Initially there was a committee for constitution of panel for
for inspection biological inspection abroad which included the concerned Director
products/units abroad which is not DBER along with Director PE&R and was Chaired by CEO,
in the public interest and it is DRAP. But currently, the DBER refers the cases to Director
because that the registration board DPER for constitution of panel.
is not allowed to constitute panel of 4.2 The list of past inspections may be presented in the board
experts that is right person for a and made part of minutes.
right job rather it is based on pick Further deliberations in Registration Board:
and choose and favoritism simply Matter for constitution of panel has has already been
to accommodate each other. deliberated at length and decided in 286th meeting Registration
Board held on 14-16th November, 2018. Chairman, Registration
Board dispelled the impression about nomination of non-
technical members in such inspection. He shared that for
inspection aborad panel comprises of 02 relevant experts taken
from DRAP‘s statutory Boards and senior officers of DRAP
having sufficient knowledge and experience. All these
nominations are endorsed by CEO, DRAP and administratively
approved by Secretray, M/o NHSR&C. During meeting, data of
inspections (panel members, manufacturing sites inspected,
name of molecule(s)/ product(s) and decision) conducted during
2017 and 2018 was also shared with Director DTL, Quetta for
further query (if any).
5. As we know that at Government Reply of DBER:
level we have some visa problem The matter is related to current Import Policy for finished
with our neighboring importing drugs. However, as per current policy if a plant has been
county (India) so it is proposed that inspected for a particular type of product, the exemption may be
if any WHO Prequalified biological granted for the same type of product within 05 years of
products coming from that inspection.
manufacturing site or if any Further deliberations in Registration Board:
biological product of that particular In addition to above, all products either pre-qualified by WHO
manufacturing site is already or approved by reference regulatoty authorities are exempted
registered with DRAP I think we from inspection of manufacturer.
can exempt inspection abroad of
that manufacturing site(s) in the
public interest as to ensure
availability of that drug for our
people.
b. Manufactures Abroad Inspection Reports

Comment Response
Reference to my couple of Note of dissents regarding unlawful constitution of panel of Already responded
experts for inspection locally and abroad for the Product specific Inspection and GMP of in point 4 above.
the manufacturer. It is observed with great concerned that the August board members are
never appraised about the inspection reports of manufacturers abroad. I strongly demand
that all the manufacturers abroad inspection reports should be shared with the august
board members for the final approval of the products likewise the local manufacturer
products inspection reports and products are discussed for final approval or otherwise.
The imported products/ molecules are initially discussed in the board and its approval is
subject to inspection report but unfortunately the abroad inspection reports are never
discussed in the board. It is also demanded that the board should be appraised about the
number of inspections abroad during the year 2018, like name of molecule(s)/ product(s),
Name of the inspectors and country of import conclusion of the panel.
B. Dr. Aslam Shah Member Registration Board, DRAP.

Comment Response
Now a days majority of Oncology Keeping in view importance of the matter, Registration
Pharmaceuticals are not available in market, even Board is already considering anti-cancer products on
with it's authorized distirbuors & the Patients are priority basis and applications submitted till December,
suffering, because their Chemotherapy cycles are 2018 has already been decided. The Board was apprised
disturbing due to non availability of drugs. The that some brands of anti-cancer drugs are in short supply /
local manufacturer Pharmadac Supplies are also not available due to closure of their abroad manufacturing
short because of their production facility facilities either due to renovation or other organizational
problems. The Anti cancer non availability matters but other alternate brands / therapeutic equivalents
problem is in now becoming chronic & I am are available. To cater such situation, DRAP is also
expecting that very soon the Voice from granting permission for import of un-registered drugs for
Oncologist, Patients, & social media will be viral, exclusive use of institutions and concerned DRAP field
so need immediate proactive actions to offices have been authorized for such granting such
resolve this problem. I would request the permissions. As far as matter of M/s Pharmaduc is
Secretary & Chairman of Registration board to concerned, the manufacturing facility is non-operative due
kindly look in to this matter to resolve on to GMP non-compliance issues. Members were also
priority. requested to identify any non-available drug for taking up
the matter accordingly. For this purpose, DRAP has already
notified a committee on availability of drugs who work in
close liason with manufacurers / importers, provincial
governments, institutions etc.

ItemNo.III: Miscellaneous Cases:
Case No.01: World Health Organization (WHO) Collaborative Procedure for Accelerated
Registration
Pakistan became signatory of WHO Collaborative Procedure for Accelerated Registration
on 23rd February 2018. The collaborative registration procedure serves to facilitate and accelerate
national registration of pharmaceutical products which the WHO Prequalification of Medicines
Team (WHO/PQT) has already assessed and prequalified. Under this agreement, WHO/PQT
assessment and inspection reports will be shared with DRAP on requirement. DRAP Authority in
its 57th meeting held on 27th March, 2018 endorsed the signing of agreement between DRAP and
WHO-PQ and gave its consent to proceed further.
Accordingly, PE&R division has prepared proposed steps for this procedure in light of
WHO Technical Report Series (TRS) as follows:
1. The foreign company must have local agent/representative in Pakistan with valid drug
sale license.
2. Applicants (companies) shall express interest (Submission of Expression of Interest) in
applying the procedure for accelerated registration to their prequalified products. The
applicant shall fill Appendix 3 Part A (WHO TRS 996_2016).
3. Applicants authorize WHO to share its assessment and inspection outcomes for the
specific product(s). The applicant shall fill Appendix 2 (WHO TRS 996_2016).
4. The authorized representative (sole agent) must submit process Fee and the complete
information required under Module 1 of DRAP CTD template (Appendix 1) (WHO TRS
996_2016).
5. The authorized representative must also submit the complete CTD dossier with proof that
same version was submitted to WHO along with any post registration variation
thereunder.
6. DRAP shall communicate its decision on whether to apply the procedure and shall fill
Appendix 3 Part B (WHO TRS 996_2016).
7. If DRAP accepts to use the collaborative procedure, DRAP will complete evaluation
process out of queue and communicate deficiencies/additional requirement within 30
days after submission.
8. In case any clarification required authorized representative (sole agent) must submit the
complete reply within 30 days.
9. On-site inspection shall be exempted for all products under this procedure being WHO
pre-qualified product.
10. Once Registration requirement are fulfilled by principle manufacturer through its
authorized representative, DRAP will complete registration process within 60 Days after
final submission. DRAP shall communicate its decision to accept/ reject registration of
the product also using Appendix 3 Part C. However, the pricing may take additional days.
11. Registration shall be granted for 5 years until and unless cancelled or revoked by
Registration Board.
12. In situations where the applicant intended to apply the procedure to a registration
application which is already pending with DRAP, the applicant should first update the
dossier to ensure that the technical part of the information is the same as that submi tted to
WHO. The applicant shall fill Appendix 2 and Appendix 3 Part A (WHO TRS996_2016).
13. All post-prequalification variations submitted to WHO shall be submitted simultaneously
to the DRAP.
Decision: Registration Board appreciated steps taken by DRAP for adopting
internationally harmonized regulation and signing agreement with
international health partners. The Board also endorsed above above
procedure which is in line with WHO Technical Report Series (TRS).

Case No. 02 Review of Quinolone- and fluoroquinolone-containing medicinal products
The case was deferred by Registration Board for further deliberation in 287 th meeting.
In May 2016 the FDA conducted a review of disabling and potentially permanent serious side
effects of systemically applied fluoroquinolones resulting in a restriction of use in less severe
infections such as acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections,
particularly in patients who have other treatment options. A similar approach was recently
followed by Health Canada.
In view of the above, Germany decided to refer the matter to the Pharmacovigilance Risk
Assessment Committee (PRAC) on 1st February 2017 that it gives its recommendation as to
whether marketing authorizations of these products should be maintained, varied, suspended, or
revoked. The referral included following drugs in all strengths, and pharmaceutical forms for
systemic and inhalational use: (Accessed from
https://www.ema.europa.eu/documents/referral/quinolone-fluoroquinolone-article-31-referral-
notification_en.pdf dated: 31-12-2018)
1. Nalidixic acid
2. Pipemidic acid
3. Cinoxacin
4. Enoxacin
5. Pefloxacin
6. Lomefloxacin
7. Ciprofloxacin
8. Levofloxacin
9. Ofloxacin
10. Moxifloxacin
11. Norfloxacin
12. Prulifloxacin
13. Rufloxacin
14. Flumequin
PRAC on 5th October 2018 completed its review and issued recommendations (Accessed
from: https://www.ema.europa.eu/documents/referral/quinolone-fluoroquinolone-article-31-
referral-prac-recommends-restrictions-use_en.pdf dated 31-12-2018) which were forwarded to
Committee for Medicinal Products for Human Use (CHMP) for its opinions. The final opinion of
CHMP was published on 16th November 2018 (Accessed from:
https://www.ema.europa.eu/documents/referral/quinolone-fluoroquinolone-article-31-referral-
disabling-potentially-permanent-side-effects-lead_en.pdf dated 31-12-2018). The
recommendations will be forwarded to European Commission for final decision. The overall
recommendations are as follows:
Disabling and potentially permanent side effects lead to suspension or restrictions of
quinolone and fluoroquinolone antibiotics
EMA has reviewed serious, disabling and potentially permanent side effects with
quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review
incorporated the views of patients, healthcare professionals and academics presented at EMA‘s
public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

EMA‘s human medicines committee (CHMP) has endorsed the recommendations of EMA‘s
safety committee (PRAC) and concluded that the marketing authorization of following
medicines should be SUSPENDED.
1. Cinoxacin
2. Flumequine
3. Nalidixic acid and
4. Pipemidic acid
The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics which included
following should be RESTRICTED.
1. Enoxacin
2. Pefloxacin
3. Lomefloxacin
4. Ciprofloxacin
5. Levofloxacin
6. Ofloxacin
7. Moxifloxacin
8. Norfloxacin
9. Prulifloxacin
10. Rufloxacin
In addition, the prescribing information for healthcare professionals and information for patients
will describe the disabling and potentially permanent side effects and advice patients to stop
treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles,
tendons or joints and the nervous system.
Restrictions on the use of fluoroquinolone antibiotics will mean that they should NOT be used:
 to treat infections that might get better without treatment or are not severe (such as throat
infections);
 to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
 for preventing traveller‘s diarrhoea or recurring lower urinary tract infections (urine
infections that do not extend beyond the bladder);
 to treat mild or moderate bacterial infections unless other antibacterial medicines
commonly recommended for these infections cannot be used.
Importantly, fluoroquinolones should generally be AVOIDED in patients who have
previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should
be used With Special Caution in the elderly, patients with kidney disease and those who have
had an organ transplantation because these patients are at a higher risk of tendon i njury. Since
the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these
medicines should be avoided.
The CHMP opinion was forwarded to the European Commission, which issued a final legally
binding decision on 14 February 2019 for Quinsair and on 11 March 2019 for other quinolone
and fluoroquinolone antibiotics given by mouth and by injection, which is applicable in all EU
countries. National authorities will enforce this decision for the fluoroquinolone and quinolone
medicines authorised in their countries and they will also take other appropriate measures to
promote the correct use of these antibiotics.. Medicines and Healthcare products Regulatory
Agency (MHRA) of UK also decided to adopt the decision of EC as a result of the EMA review.
Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 10

Information for Healthcare Professionals:
 Fluoroquinolones are associated with prolonged (up to months or years), serious,
disabling and potentially irreversible drug reactions affecting several, sometimes
multiple, systems, organ classes and senses.
 The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities,
gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory
impairment, sleep disorders, and impaired hearing, vision, taste and smell.
 Tendon damage (especially to Achilles tendon but also other tendons) can occur within
48 hours of starting fluoroquinolone treatment but the damage may be delayed several
months after stopping treatment.
 Patients who are older, have renal impairment or have had solid organ transplantation and
those being treated with a corticosteroid are at higher risk of tendon damage.
Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
 Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or
inflammation and patients should be advised to stop treatment with a fluoroquinolone and
speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling,
numbness or weakness so as to prevent development of potentially irreversible condition.
 Fluoroquinolones should generally not be used in patients who have had serious adverse
reactions associated with the use of quinolone or fluoroquinolone medicines.
 Up-to-date summary of product characteristics should be consulted for
authorized indications when considering treatment with a fluoroquinolone medicine. This
is because the indications for these medicines have been restricted.
 The benefits and risks of fluoroquinolones will be monitored continuously and a drug
utilization study will evaluate the effectiveness of the new measures to reduce
inappropriate use of fluoroquinolones by investigating changes in prescribing behavior.
Information for Patients:
 Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin,
moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause
long-lasting, disabling and potentially permanent side effects involving tendons, muscles,
joints and the nervous system.
 These serious side effects include inflamed or torn tendon, muscle pain or weakness, and
joint pain or swelling, walking difficulty, feeling pins and needles, burning pain,
tiredness, depression, problems with memory, sleeping, vision and hearing, and altered
taste and smell.
 Tendon swelling and injury may occur within 2 days of starting treatment with a
fluoroquinolone but may even occur several months after stopping treatment.
 Stop taking a fluoroquinolone medicine and contact your doctor at once in the following
cases:
o at the first sign of tendon injury, such as tendon pain or swelling – rest the painful
area;
o if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or
weakness especially in the legs or arms;
o if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired
or depressed or have problems with your memory or with sleeping or you notice
changes with your vision, taste, smell or hearing. You and your doctor will decide
if you can continue treatment or if you need to take another type of antibiotic.
 You may be more prone to joint pain or swelling or tendon damage if you are aged over
60 years, your kidneys do not work well or you have received organ transplantation.
 Speak with your doctor if you are taking a corticosteroid (medicines such as
hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. You
may be especially prone to tendon damage if you are taking a corticosteroid and a
fluoroquinolone medicine at the same time.
 You should not take a fluoroquinolone medicine if you have ever had a serious side effect
with a fluoroquinolone or a quinolone medicine and you should speak with your doctor
immediately.
 If you have any questions or concerns about your medicines, speak to your doctor or
pharmacist.
Decision: Keeping in view status of product in reference regulatory authorities,

Registration Board decided as follows:
 to initiate process / issuance of show cause for suspension / cancellation of
first generation quinolones (cinoxacin, flumequine, nalidixic acid and
pipemidic acid) due to serious safety concerns in injectable, oral and
inhalational formulations.
 To update indications of second generation fluoroquinolones for
consideration of Registration Board.
Case No.03: De-Registration of Dettol Liquid (Reg. No.000150) – M/s Reckitt Benckiser
Pakistan Ltd, Karachi
M/s Reckitt Benckiser Pakistan Ltd, Karachi has informed that Dettol Liquid, Reg.
No.000150 registered in April, 1976 as per Drugs Act 1976 (―Act‖) as an antiseptic and
disinfectant. However as per promulgation of DRAP Act, 2012 disinfectants belong in ―health
and OTC products (non –drugs)‖catetory. This category is now headed by a separate Directorate
Health & OTC products (non-drugs) for which registration and licensing is done separately for
which the OTC Enlistment Rules are soon to be notified.
Dettol is a world famous brand used by general population for personal cleaning and
hygiene since generations. The proposed OTC Enlistment Rules clearly states, as per definition
para (d) and (i), as follows;
(d) ―Disinfectant‖ means a health product or ingredient used for destroying or inhibiting micro
–organisms that may b harmful to humans or animals. Disinfectants also include ingredients or
products having additional antiseptic activity.

(i) ―Health products‖ means Health and OTC products (non-drugs) as denined in the Act and
include pro-biotics, disinfectants, food supplements, nutritional products, baby milk and foods,
medicated cosmetics, medicated soaps, medicated shampoos, medical plasters and derma-care
products or any other which may be notified in official gazette y DRAP as Health and OTC
products;
Also as per the National Essential medicines List of Pakistan, Ministry of Health, Government of
Pakistan – 2007 list, clause number 15.2, chloroxylenol 4.8% is included as a disinfectant. The
present usage of their product Dettol ASL (after dilution) as per a local study conducted by M/s
TNS Aftab& Associates in 2010, is as follows;
 Bathing – 80%
 Cuts & Bruises – 58%
 Washing clothes – 58%
 Shaving – 45%
 Nappies cleaning – 31%
 Allergy – 20%
 Floor Cleaning – 12%
 Kitchen slab cleaning – 9%
 Bathroom cleaning – 8%
The above data clearly delineates that the product usage is OTC unlike any medicine by
general public and not requiring any prescription by physicians. The study in its entirety is
attached for perusal.
Their product Dettol ASL is also amenable to Sales Tax on goods under the Sales Tax
Act, 1990 while all products registered under the Drugs Act, 1976 are exempt from sales tax. An
exception has been created for those products that are registered under the Act but are
disinfectants. Their product, is therefore, also treated as a disinfectant by all taxing authorities.
That all that is sated above categorically demonstrates that their product, Dettol ASL is a
disinfectant under the Act and clearly falls under the sub-category of Health and OTC products
(Non-Drugs) under the DRAP Act. This sub-category is now liable to be treated separately under
the OTC Rules, as it is presumed there will be less stringent regulation for those products that are
not life saving or therapeutic drugs, for which an entirely separate Directorate has been created.
Therefore, by enlistment of their product they would continue paying GST along with
deregulation and de-registration by DRAP from the general category and eventual enlistment and
registration in the specific sub-category they fall within. This will enable their consumers to
continue their endeavors in attaining health and hygiene resulting in;
 Maintaining continuous revenue for the government
 Spreading of Health Education with ongoing projects like ―Save the Children‖ with
Government of Pakistan
 Their company has initiated various health and hygiene programs in Schools and
Hospitals for the benefit of common people.
In view of the foregoing, they would humbly urge to look into the matter with the above facts
mentioned which favor Dettol Antiseptic Liquid being enlisted separately as a Health & OTC
product (non-drug) after which a fresh letter of registration and new MRP may be issued keeping
the facts that it is not a life saving or essential therapeutic drug in mind.

Decision of M-245: Registration Board deferred all products for personal hearing /
presentation before Registration Board.
M/s Reckitt Benckiser Pakistan Private Limited has filed a Civil Suit No.264-2016 by
before the High Court of Sindh vs Federation of Pakistan and others and Sindh High Court has
passed an order dated 29-04-2019 i.e., summarized as under:
“The plaintiff has impuged letter dated 07.07.2015 which has been issued in response to
the Plaintiff‟s application dated 16.02.2015 whereby, they had requested the Drug
Regulatory Authority to enlist their product covered by this suit under the alternative
Medicines & Health Products Enlistment Rules, 2014. In the said letter it is stated by the
DRAP that since the product in question has already registered under the Drug‟s Act
1976, hence, now, it cannot be enlisted under the 2014 Rules. On perusal of the said
letter it appears that DRAP has not assigned proper reasons as to the objections raised
by the Plaintiff vis-à-vis. the applicability of the DRAP Act, 2012. Since apparently
proper reasons have not been assigned by DRAP through letter dated 07.07.2015, the
matter is remanded to the Drug Regulatory Authority of Pakistan to decide the
application of the Plaintiff with proper reasons after affording opportunity of hearing to
the plaintiff and pass appropriate orders in accordance with law. Furthermore, such
exercise be preferably carried out within a maximum of 60 days from today and till then,
no coercive action shall be taken against the Plaintiff.”
Aforementioned in view, M/s Reckitt Benckiser Pakistan was called (vide letter dated 09-
05-2019) for personal hearing before the Registration Board on 14-05-2019. However, the firm,
vide their letter dated 13-05-2019, raised following objections to the contents of letter issued for
personal hearing:
a. The High Court has not remanded the matter back to the Registration Board. You will
note that the order makes specific reference to letter dated 07th July 2015.Such letter
was issued by the Directorate Health & OTC Products (non-drugs).Therefore, the
remand order is directed at the Directorate Health & OTC Products (non-drugs) and
the personal hearing is to be conducted by officials of such Directorate.
b. Furthermore, the Registration Board is not a defendant in Suit No.264 of 2016.
Defendant No.3 is the Director Health & OTC Products (Non-drugs) and Defendant
No.4 is the Deputy Drug Controller Health & OTC Products (Non-drugs). The
direction of the High Court in the Order is quite clearly issued to such Defendants and
not to a party that is not a Defendant in the Suit.
Furthermore, the firm has also stated that:

1. Without prejudice to the above, the Company is also in the process of filing a High Court
Apeal (―HCA‖) against the order of the High Court. It seeks reversal of the Order and suspension
in the interim and shall, therefore, not enter any remand proceedings whether before the
Registration Board or the Directorate Health & OTC Products (non-drugs) till such time that the
HCA is first heard. Entering remand proceedings shall divest the Company of its right of
impugning the remand order & you are, therefore, requested to permit the Company to exercise
its statutory right of appeal for which it has 20days from the date of issuance of the Order under
the law.
2. In the meanwhile you are requested to respond to our objections with reasons of
alternatively, and ideally, to transfer the matter to the competent authority in light of Order of the
High Court which has remanded the matter to and ordered that a personal hearing be granted by

the Directorate Health & OTC Products (Non-Drugs) (Defendant Nos. 3 & 4) and not the
Registration Board.
3. Consequent to the above, internal and legal representatives of the Company will not be
attending the personal hearing on the 14 May, 2019.
4. It may be noted that the company also reserves its right to file an appropriate application
before the High Court in Suit No. 264 of 2016 in the event that the Registration Board proceeds
any further in this matter.
Decision: Keeping in view the above mentioned sitauation, Registration Board decided
to seek opinion of Legal Affairs Division, DRAP for further processing of
case.
Case No.04. Risks & Concerns Associated with Dydrogesterone.

A number of applications have been received by Pharmaceutical Evaluation & Registration
Division for registration of Dydrogesterone Tablets. While evaluation, it was identified that the
applied formulations were based on "Cis Isomer" of Dydrogesteronei.e not in compliance with
the USP monograph for dydrogesterone tablet & European Pharmacopeial monograph for
dydrogesterone API, both of which state "trans isomeric form".
The observation was further confirmed by reviewing innovator‘s formulation approved by
following Reference Regulatory Authorities:
a. ANSM France (Duphaston, Authorization Holder: MYLAN MEDICAL SAS)
b. CBGMEB Netherlands (Duphaston; Reg. No. RVG 107765/ 05619)
c. AGES Austria (Duphaston, Owner: BGP Products GmbH, Perfektastrasse 84A, 1230
Vienna, Austria)
d. Swissmedic Switzerland
Concerns Raised by Abbott Laboratories:
M/ s Abbott Laboratories (Pakistan) Ltd. has raised the same issue and highlighted following
points of concern & risks associated with the use of mislabeled Dydrogesterone:
 Solvay Pharmaceuticals is the only company in the world which manufactures
dydrogesterone because manufacturing requires a proprietary technique.
 In Pakistan, dydrogesterone was only marketed by Solvay‘s agents, Highnoon
Laboratories Limited under the brand name of DUPHASTON i.e currently owned by
Abbott Laboratories.
 Dydrogesterone manufacturing process involves, as an essential step, a photochemical
reaction which leads to conversion of configuration. The manufacturing of 6-
dehydroprogesterone lacks the photochemical conversion step resulting in substantially
different 3D structure.
 Different structures lead to different pharmacological profile such that efficacy of these
two molecules differ significantly.
 The clinical data on efficacy and/or safety is not available for 6-dehydroprogesterone
lacking the proof that this is any beneficial for the patient. As there is no data in support
of 6- Dehydroprogesterone, it cannot be evaluated in comparison to dydrogesterone in
terms of safety & efficacy.
Furthermore, M/s Abbott has submitted following supportive studies:
i. Drug analysis conducted on products claiming as dydrogesterone at:
1) Abbott‘s MS&T Analytical Sciences & Technology, Weesp, The Netherlands.
2) Industrial Analytical Center, HEJ Research Institute of University, University of
Karachi.

The results of the chemical analysis revealed the main component as 6-
dehydroprogesterone & not dydrogesterone.
ii. Results Deduced From Comparative Molecular Modeling Study:
Dydrogesterone possesses a biological potency significantly higher than progesterone
itself as it takes advantage both from its retro structure and from the presence of the C6-
C7 double bond, which constricts the molecule into a rigid conformation probably
suitable for the interaction with the progesterone receptor. Moreover, as a consequence
of its better bioavailability and the progestational activity of its main metabolites (20-,
21- and 16-hydroxy derivatives), its equivalent dose, regarding the endometrial
proliferation, is 10-20 times lower than that of progesterone itself.
Previous Proceeding:
In 2008 M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd. Karachi, appealed before the
Appellate Board against the decision of Registration Board regarding stoppage of production of
their drug "Dirogest Tablets" containing "Dydrogesterone Cis Isomer", for local manufacture.
The Appellate Board in its 134th meeting held on 17-06-2008 after considering the following
arguments & merits of the case, accepted the appeal since no scientific evidence contravened the
arguments made by M/s Zafa.
Mr. Muhammad Amin Khan, C.E.O., Mr. Jawad Amin Khan, MD,
Mr.Muhammad Aslam Shah, GM Technical & Mr. Hassan Masood Naqvi,
Assistant Sales Manager of the firm appeared before the Board on behalf of the
firm & stated that "Dirogest Tablets" containing "Dydrogesterone Cis Isomer
was registered in 2002 and since then they are marketing the said drug without
any complaint from the doctors/ market. They had been selling more than
100000 packs per year & no complaint had been received about their efficacy.
They further added that the said drug was also available in Israel & Syria. They
informed the board that comparative study of the two different dosage of the
drug had been conducted in John Hopkins Bloomberg School of Public Health
and some trials in different hospitals in Pakistan had been conducted. They also
informed the board that their drug was cheaper than its competitors in the
market.
It is however, submitted that Duphaston is the proprietary name of the dydrogesterone contai ning
product registered by Ministry of Health, Israel in the name of ABBOT MEDICAL
LABRATORIES LTD, ISRAEL. Moreover, M/s Zafa, in order to prove their stance, is obliged
to provide data regarding aforementioned comparative study.
Findings:
Besides progesterone, the natural progestational agent, many synthetic progestins are
known. One of the classes is represented by ―Retrosteroids‖ and the most representative
compound among these is 6-dehydroretroprogesterone (dydrogesterone). Another progestin
considered in this regard is 6-deydroprogesterone (Cis Isomer), having a molecular structure
almost identical to that of 6-dehydroretroprogesterone (dydrogesterone), however in
dydrogesterone molecule, the hydrogen atom at C-9 is at beta position & methyl group at C-10 is
at the alpha position (Figure1). Whereas 6-Dehydroprogesterone has a reverse configuration at
position C-9 & C-10 (Figure2), hence the term ‗retro‘ progesterone. The acetyl group at C-17 in
both structures have same configuration.

Structural Comparison of 6 – Dehydroprogesterone and Dydrogesterone
Figure1
Figure 2
Both the isomers have different physical properties confirming these to be different
pharmaceutical entities.
S.No. Attributes Cis Isomer Trans Isomer
1 Chemical Name 6-Dehydroprogesterone 6-Dehydroretroprogesterone
2 Molecular Weight 312.45 312.45
4 CAS Number 1162-56-7 152-62-5
5 Specific Rotation +170º- +182º -469-485(dried substance)
measured at 25ºC
6 Melting point 142-148ºC 167-171ºC
7 Relative Retention Time towards 1.17 min 1min
Dydrogesterone
(Reverse phase HPLC with UV Detector)
USP38-NF33
The Registration Board in its 281 st meeting deferred the case for final comments from
PPMA. The board advised the observers of the PPMA to submit their response in the matter
within 15 days without waiting for any letter from DRAP. Board further directed to present all
the deferred cases in the next meeting.
Decision of M-284:
Registration Board deferred the case for final comments from PPMA. The board advised
the observers of the PPMA to submit their response in the matter within 15 days without waiting
for any letter from DRAP. Board further directed to present all the deferred cases in the next
meeting.
In this regard, a reminder has also been issued to PPMA dated 22-10-2018 to comments
within 07 days for consideration and finalization of the case by PPMA.
Decision of M-286: Registration Board deliberated the case in the light of above stated facts
and findings and decided as under:
Since USP monograph for Dydrogesterone states CAS No. “152-62-5” i.e
assigned to “Trans Isomeric Form; 6-Dehydroretroprogesterone” and as
per Drugs Specification Rules 1978, “drug products registered with any
official pharmacopoeial specifications shall follow specifications present
in the latest edition of that publication”. Furthermore, as per information
available on web, approval status of “Cis Isomeric Form” of
dydrogesterone could neither be confirmed in any Reference Regulatory
Authority nor in Syria and Israel. Therefore, the Board referred the case
to the Appellate Board with the request to review the decision taken vide
its 134th meeting, held on 17-06-2008.
Accordingly, the case was considered by the Appellate Board as per following details.
i. The representative of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, requested for
adjournment.
ii. The Representative of M/s Abbott Laboratories Pakistan Ltd, contended that there are
following differences Dydrogesterone and 6-Dehydroprogesterone.
Dydrogesterone (Duphaston) 6-Dehydroprogesterone.
Dydrogestrone is ―Retro-Steroid‖ shaped by A synthetic derivative and natural metabolite of
photochemical conversion ( Trans-Isomer) progesterone, a steroid isomer of Dydrogesterone but not
retro-steroid (Cis-Isomer)
Due to Retro Steroidal nature it is highly No such benefit is offered as the chemical structure is not
selective for the progesterone receptor. retro-steroid.
Due to the retro-steroidal nature its metabolites Non-retro-steroid are not only metabolized to a greater
are progestogenic extent but also have a potential to generate in active
metabolites with secondary effects that are non-
progestrogenic.
As of April 22, 2019, 623 articles are available Clinical data for use of 6-Dehydroprogesterone is lacking.
for the use of Dydrogestrone out of which 205
publications are clinical trials in humans.
Extensive data and clinical experience world Due to lack of data there is a possibility of patient exposed
vide. to increased health risk or worsening of their medical
condition.
iii. It was further argued that there are various companies promoting medicines containing 6-
Dehydroprogeesterone but claiming that the active ingredient is Drydrogesterone and that
they have the same indications, properties and action as Abbott‘s original molecule
Dydrogesterone (Duphastan). The clinical data/study on the efficacy and safety is not
available for 6-Dehydrogprogesterone. Available pre-clinical data is conclusive of the
fact that 6-Dehydroprogesterone as a very low biological activity as compared to
progesterone. In the absence of clinical data supporting the use of 6-
Dehydroprogesterone, it cannot be evaluated if this molecule is comparable to
Dydrogesterone in terms of safety and efficacy. Mislabeled dygrogesterone has not been
fully tested for its safety or efficacy and therefore patient offered such medicines are not
only exposed to increased health risks in terms of suboptimal effects leading to
compromised health, but also to direct side effects. This further becomes point of concern
in cases where with use of mislabeled products there is expected exposure to fetus.
iv. The Board considered the facts of the case and decided not to adjourned the hearing as
requested by M/s Zafa Pharmnaceuticals Laboratories (Pvt) Ltd, Karachi, being a matter
of public health importance. The board agreed with the scientific opinion/justification and
interpretation of the drugs (Specifications) rules,1986 by the registration board in its 286 th
meeting held on 14th-16th November, 2018. The board directed the pharmaceutical
Evaluation and Registration Division to ensure that all registered formulation/products
and evaluation of Dydrogesterone products must comply with the official pharmacopeial
monograph i.e USP. The board further directed the division of QA&LT to allow the
import of API for registered products of Dydrogesterone as per official monograph only
and to issue a circular for information of all concerned.
Decision: Registration Board advised to comply directions / decision of Appellate
Board.

Case No. 05: Minutes of 07th Meeting of Expert Working Group on Veterinary Drugs
Held on 13th May, 2019.
A. Use of multidose Oxytocin vials in Veterinary.

The meeting was conducted on the issue of alleged misuse of Oxytocin multi-dose vials in
veterinary for the purpose of milk production. The matter was deliberated extensively by the
participants. Decisions/discussion is as follow;
a. Dr. Muhammand Akram informed the committee that Oxytocin is, primarily, used in
veterinary for the purpose of milk letdown. He further informed that the half life of
Oxytocin Injection is around 02 minutes and withdrawal period of oxytocin in milk and
meat is zero hours and zero days respectively. About 1-2cc of the injection is used for
milk letdown.
b. The Committee/participants decided to expand the consultation horizon to a national
consultation process/level and include the following relevant/technical experts in order to
probe the matter in detail and a meeting in this regard shall be convened in near future;
i. Human and veterinary Endocrinologists.
ii. Expert from M/o. Food Security.
iii. Director General‘s of livestock departments of all provinces.
Decision:- Registration Board endorsed the decision made in 07 th meeting of Expert
Working Group on Veterinary Drugs.
B. M/s. Mustafa Brothers, Faisalabad:

Importer and Manufacturer Brand Name and Composition Decision of 269th
meeting
M/s. Mustafa Brothers ARRIAH PPRV 269th
186-D, Peoples Colony No. 1, (Virus vaccine against PesteDesPetitis
Faisalabad Ruminants Cultural Dry) Registration Board
Manufacturer: approved the product
M/s. Federal Governmental The Virus vaccine against PesteDesPetitis as per import policy for
Budgetary Institution ―Federal Ruminants Cultural Dry contains Peste Des finished drugs and as
Centre for Animal Health‖ Petitis Ruminants virus of ―ARRIAH‖ strain. per valid legalized
(FGBI‖ARRIAH‖) GMP & Free sale
600901, Russia, Vladimir Each inoculating dose contains: certificate
region, Vladimir, PPRV vaccine strain ―ARRIAH‖ not less than
microrayonYur‘ evets 1000TCID50. Approved
th
Decision of 5 meeting of Expert working group: - Expert working group deferred the application for
submission of exact strain name of PPRV virus used along with its scientific immunological relevance in
Pakistan by the firm.
Now the firm has submitted the following reply.

a) PPRV ―Virus Vaccine Against Peste Des Petits Ruminants Cultural Dry‖ strain clarification received
from our manufacturer FGBI ARRIAH ―Federal Center For Animal Health‖ Vladimir Russia is
enclosed. The main virus of this vaccine strain is Nigeria 75/1 ―ARRIAH‖ enclosed.
b) Publication ab2out PPRV ―Virus Vaccine Against Peste Des Petits Ruminants Cultural Dry‖
manufactured by FGBI ―ARRIAH‖ enclosed.
c) Scientific immunological relevance of PPRV ―Virus Vaccine Against PesteDes Petits Ruminants
Cultural Dry‖ in Pakistan ―Nigeria 75/1‖ is attached:
For scientific immunological relevance in Pakistan, the firm has submitted a research article title,authors
details,Abstract and its conclusion is reproduced as under.(The submitted article is annexed with the agenda)
“Peste des Petits Ruminants Vaccine
(Nigerian Strain 75/1) Confers Protection for at Least 3 Years in Sheep and Goats

Aamer Bin Zahur1, Hamid Irshad1, Aman Ullah1, Muhammad Afzal2, Asma Latif1, RiasatWasee Ullah1, Umer
Farooq1, Muhammad Humayoon Samo2, Muhammad Jahangir2, Giancarlo Ferrari 3, Manzoor Hussain2, M.
Munir Ahmad4
1
Animal Health Research Laboratories, Animal Sciences Institute, national Agricultural Research Center,
Islamabad, Pakistan
2
FAO-UN Pakistan (GCP/PAK/127/USA) NARC, Park Road, Islamabad, Pakistan
3
AGAH, FAO (Hq), Rome, Italy
4
Divisional diagnostic Laboratory, Livestock and Dairy Development Department, Multan, Pakistan
Email: *hamidirshad@hotmail.com
Abstract
The present study reports the duration of immunity and protective efficacy of Peste des Petits Ruminants
(PPR) vaccine (Nigerian strain 75/1) in sheep and goats. A total of 105 sheep and goats were divided into
three groups A, B and C. Group A received normal recommended dose (1.0ml) of PPR vaccine, group B
received half dose (0.5ml) of PPR vaccine and group C was kept as unvaccinated control group in contact
with vaccinated animals. The post vaccination dynamics of antibodies against PPR virus was studied. It was
found that significant antibody titres persisted for 3 years post vaccination in sheep and goats vaccinated with
either full dose or half dose of PPR vaccine. The challenge protection studies were carried out in
experimental animals at 24 and 36 month post vaccination. The vaccinates withstood challenge and were
found completely resistant clinically and virologically to virulent PPR virus for 24 and 36 months post
vaccination. The unvaccinated control animals developed typical clinical signs of PPR and the challenged
virus was detected in ocular, nasal and oral secretions of these animals. This study demonstrated that a single
immunization with PPR vaccine conferred solid protection in sheep and goats for 3 years.
Conclusion
The economic life of small ruminants is about 3 years. This study indicated that PPR vaccine (Nigerian strain
75/1) provides immunity for 3 years. Therefore, the strategic use of this vaccine will be useful in reducing the
impact of infection in the areas where the disease is endemic.”
Decision :
Expert working group noted that the Peste Des Petitis Ruminants (PPR) virus strainARRIAH is brand name of
the Peste Des Petitis Ruminants (PPR) vaccine (Nigerian strain 75/1). The same strain is already registered in
Pakistan therefore the working group recommended the veterinary vaccine i.e. ARRIAH PPRV by M/s.
Mustafa Brothers, Faisalabad for registration and recommended the replacement of the word ―ARRIAH‖
with ―PPR vaccine (Nigerian strain 75/1)‖ in composition.
Decision:- Keeping in view the recommendation of Expert Working Group on Veterinary
Drugs, Registration Board decided to approv the above mentioned product of M/s. Mustafa
Brothers, Faisalabad with replacement of the word ―ARRIAH‖ with ―PPR vaccine (Nigerian
strain 75/1)‖ in composition.

Item No. IV Division of Pharmaceutical Evaluation & Registration.
Pharmaceutcial Evaluation Cell (PEC)

Case No. 01 Registration applications for local manufacturing of (Human) drugs
a. New cases
b. Deferred cases
Case No. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
b. New/Additional section(s)
Case No. 03 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
b. Deferred Cases
Case No. 04 Registration applications of newly granted DML or New section (Veterinary)
a. New DML /section
b. Deferred Cases
Case No. 05 Registration applications of categories to be considered on priority

a. Local manufacturing applications of priority categories defined by Registration
Board in its 257th meeting
b. Export facilitation
c. Import applications of priority categories defined by Registration Board in its
257th meeting
i. Human
ii. Veterinary
Case No. 06 Registration applications of import cases

a. New Cases (Human)
b. New Cases (Veterinary)
c. Deferred cases
i. Human
ii. Veterinary
Case No. 07 Registration applications of drugs for which stability study data is submitted
a. New cases
b. Deferred cases
c. Verification of stability study data
d. Exemption from onsite verification of stability data
Case No. 08 Miscellaneous cases

Sr. No Name of Evaluator Title
1. Mr. Awais Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Mst. Sidra Khalid Evaluator PEC-VII
8. Mst. Haleema Sharif Evaluator PEC-VIII
9. Mr. Sarfraz Evaluator PEC-X
10. Mr. Haneef Ullah Evaluator PEC-XI
11. Syed Ajwad Bukhari Evaluator PEC-XII
12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

13. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Evaluator PEC-II
Case no. 01 Registration Applications for Local Manufacturing of (Human) Drugs.
a. New Cases:
1. Name and address of manufacturer / "M/s Aspin Pharma Pvt Ltd. Plot # 10 & 25, Sector 20,
Applicant Korangi Industrial Area, Karachi 74900, Pakistan"
Brand Name +Dosage Form + Strength Onran 4mg Tablet
Composition "Each Film Coated Tablet Contains:
Ondansetron as hydrochloride dihydrate ….…4mg"
Diary No. Date of R& I & fee Dy. No 10161 dated 19-03-2018 Rs. 20,000/- 19-03-2018
Pharmacological Group Antiemetic
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price As per latest DPC
Approval status of product in Reference Approved by MHRA of UK
Regulatory Authorities
Me-too status (with strength and dosage Oniron 4mg Tablets of M/s Genome Pharmaceuticals, (Reg.#
form) 068374)
GMP status Firm has submitted copy of GMP inspection report conducted
on 20-2-2018, concluding as under:
―Based on the areas inspected the document reviewed and
considering the finding of inspection M/s Aspin Pharma is
considered to be operating at satisfactory level of compliance
with respect to cGMP guidelines as per Drug Act 1976 and
DRAP Act 2012.‖
Remarks of the EvaluatorII
Decision: Approved.
Brand Name +Dosage Form + Strength Onran 8mg Tablet
Ondansetron as hydrochloride dihydrate ….…8mg"
Type of Form Form-5
Me-too status (with strength and dosage Oniron 8mg Tablets of M/s Genome Pharmaceuticals, (Reg.#
form) 068375)
GMP status As recorded for above application
Decision: Approved.
Brand Name +Dosage Form + Strength Fosvac 20mg Tablet
Composition "Each Tablet Contains:
Fosinopril Sodium…20mg"
Pharmacological Group Antihypertensive.
Type of Form Form-5
Me-too status (with strength and dosage Not available
form)
Remarks of the EvaluatorII Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm or else apply on form
5-D along with stability data.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm or else apply on
relevant Form along with stability data.
Type of Form Form-5
Me-too status (with strength and dosage Aksopril Tablets 10mg of M/s Akson Pharmaceutical (Pvt)
form) Ltd (Reg.#023747)
Decision:Approved.
Brand Name +Dosage Form + Strength Jormia XR 1000mg Tablet
Composition "Each Extended Release Tablet Contains:
Metformin Hydrochloride…1000mg"
Pharmacological Group Antidiabetic
Type of Form Form-5
Approval status of product in Reference Approved by USFDA
Me-too status (with strength and dosage Dowphage ER 1000mg Tablet of M/s Martin Dow Ltd.
form) Karachi. (Reg.#081129)
Decision:Approved.
Type of Form Form-5

form)
number, brand name and name of firm or else apply on form
5-D along with stability data shall be submitted.
Upon communication of above observation firm has replied
that We would like to inform you that we are working on
Form 5D dossier of the subject product and will provide
updated dossier once completed as required by your good
office‖
Decision:Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
Brand Name +Dosage Form + Strength Anprox 500mg Tablets
Naproxen Sodium 547.74mg Eq. to Naproxen…500mg"
Diary No. Date of R& I & fee Dy. No 10153 dated 19-03-2018 Rs.20,000/- 19-03-2018
Pharmacological Group NSAID
Type of Form Form-5
Me-too status (with strength and dosage Nextar 500mg Tablets of M/s Novamed Pharmaceuticals
form) (Reg.# 076824)
Decision:Approved.
Brand Name +Dosage Form + Strength Anprox 250mg Tablets
Composition Each Tablet Contains:
Naproxen Sodium 273.8mg Eq. to Naproxen…250mg
Type of Form Form-5
Me-too status (with strength and dosage Nextar 250mg Tablets of M/s Novamed Pharmaceuticals
form) (Reg.# 076823)
II
Remarks of the Evaluator
Decision:Approved.
Brand Name +Dosage Form + Strength Lanzap 30mg Tablet
Composition "Each Oral Disintegrating tablet Contains:
Lansoprazole enteric coated Pellets (8.5%) 352.94mg Eq. to
Lansoprazole…30mg"
Pharmacological Group Antacids
Type of Form Form-5
Pack size & Demanded Price 10‘s,20‘s & 30‘s; As per latest DPC
Me-too status (with strength and dosage --
form)
DRAP (generic/me-too status) alongwith registration number,
brand name and name of firm or else apply on form 5-D along
with stability data shall be submitted.
Upon communication of above observation firm has replied
that We would like to inform you that we are working on
Form 5D dossier of the subject product ad will provide
updated dossier once completed as required by your good
office‖
Brand Name +Dosage Form + Strength Lanzap 15mg Capsule
Composition "Each Delayed Release Capsule Contains:
Lansoprazole…15mg"
Pharmacological Group Antacid
Type of Form Form-5
Pack size & Demanded Price 30‘s; As per latest DPC
Me-too status (with strength and dosage Getlanso Capsules 15mg of M/s Getz Pharmaceuticals. (Reg.#
form) 061098)
II
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
Brand Name +Dosage Form + Strength Lanzap 30mg Capsule
Composition Each Delayed Release Capsule Contains:
Lansoprazole…30mg
Type of Form Form-5
Pack size & Demanded Price 30‘s; As per latest DPC
Me-too status (with strength and dosage Getlanso Capsules 30mg of M/s Getz Pharmaceuticals. (Reg.#
form) 061099)
II
12. Name and address of manufacturer / M/s Heal Pharmaceuticals Pvt Ltd. W-33 Industrial Estate,
Applicant Hayatabad, Peshawar
Brand Name +Dosage Form + Strength S-Butamol Syrup
Composition "Each 5ml Contains:
Salbutamol as Sulphate…2mg"
Pharmacological Group Selective β2 agonist
Type of Form Form-5
Finished product Specifications BP
Pack size & Demanded Price As per SRO
Me-too status (with strength and dosage Ezibreath Syrup of M/s Rock Pharmaceuticals Laboratories,
form) (Pvt) Ltd., (Reg.# 064242)
on 25-07-2017, recommending grant of renewal of DML.
Decision:Approved.
Brand Name +Dosage Form + Strength Healkast 10mg Tablets
Composition "Each film coated Tablet Contains:
Montelukast as sodium…10mg"
Pharmacological Group Leukotriene antagonist
Type of Form Form-5
Me-too status (with strength and dosage Montekast 10mg Tablets of M/s Global Pharmaceuticals.
form) (Reg.# 032154)
Decision:Approved.
Brand Name +Dosage Form + Strength Helakast 4mg Sachet
Composition "Each Sachet Contains:
Montelukast as sodium …… 4mg"
Pharmacological Group Leukotriene antagonist
Type of Form Form-5
Me-too status (with strength and dosage Aerotel Sachet of M/s Highnoon Laboratories. (Reg.#044768)
form)
II

Decision:Approved.
Brand Name +Dosage Form + Strength Healtrem 80/480 mg Tablets
Composition Each film coated Tablet Contains:
Artemether ….… 80mg
Lumefantrine ……. 480mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished product Specifications IP
Approval status of product in Reference WHO recommended formulation
Me-too status (with strength and dosage Artem -DS Plus Tablets 80/480 of M/s Hilton Pharma,
form) Karachi (Reg.# 066843)
Remarks of the EvaluatorII In contrary to reference product recommended by WHO,
which is available as uncoated tablet, you have applied for
film coated tablet.
Decision:Deferred for revision of formulation as per reference product along with submission of
requisite fee for change of formulation.
Brand Name +Dosage Form + Strength H-Fenac 100mg Tablets
Aceclofenac…100mg"
Pharmacological Group Anti-rheumatic
Type of Form Form-5
Finished product Specifications Manufacturer‘s specifications
Me-too status (with strength and dosage Aclofen Tablets by M/s Alliance Pharmaceuticals (Pvt) Ltd,
form) (Reg.# 068419)
Remarks of the EvaluatorII No USP or BP monograph is available for applied
formulation.
Decision:Approved with innovator‘s specification.
Brand Name +Dosage Form + Strength Alumag 200/200/20 mg Suspension
Aluminium Hydroxide…200mg
Magnesium Hydroxide…200mg
Simethicon……20mg"
Type of Form Form-5
Finished product Specifications Manufacturer specifications
Approval status of product in Reference Not verifiable
Me-too status (with strength and dosage Not verifiable
form)
Remarks of the EvaluatorII  Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting.
 Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
Decision: Deferred for following:
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm
 Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were adopted by the Registration Board in its 275 th meeting.
Brand Name +Dosage Form + Strength Flutin 20mg Capsule
Composition "Each Capsule Contains:
Fluoxetine as hydrochloride…20mg"
Pharmacological Group Selective Serotonin Reuptake Inhibitor
Type of Form Form-5
Me-too status (with strength and dosage Flufend Capsules 20mg of M/s Friends Pharma (Pvt.) Ltd
form) (Reg.# 044757)
Decision:Approved.
Brand Name +Dosage Form + Strength Healsoda Sachet
Composition "Each 4gm Sachet Contains:
Sodium bicarbonate …… 1.716gm
Citric Acid …… 0.702gm
Sodium Citrate ..…0.613gm
Tartaric Acid ……0.858gm"
Type of Form Form-5
Me-too status (with strength and dosage Citro Soda sachet of M/s Abbott (Reg.#008749)
form)
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
20. Name and address of manufacturer / "M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Applicant Karachi, 75190, Pakistan"
Brand Name +Dosage Form + Strength Azelin Nasal Spray
Composition "Each ml Contains:
Azelastine Hydrochloride…1mg"
Pharmacological Group Antiallergic
Type of Form Form-5
Pack size & Demanded Price 15ml & 30ml; As per PRC
Me-too status (with strength and dosage Azosin nasal spray of M/s Sante (Reg.#025165)
form)
on 16-02-2018, concluding satisfactory level of compliance
with cGMP guidelines as of today.
Remarks of the EvaluatorII Firm has sterile Drops (ophthalmic, Ear & Nose) section as
per submitted GMP inspection report.
21. Name and address of manufacturer / "M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Applicant Karachi, 75190, Pakistan"
Brand Name +Dosage Form + Strength Crolate 20mg/ml Eye Drops
Composition "Each 1ml of Eye Drops Contains:
Sodium Cromoglicate …… 20mg‖
Diary No. Date of R& I & fee Dy. No 10132 dated 19-03-2018 Rs. 20,000/- Dated 19-03-
2018
Pharmacological Group Antihistamine
Type of Form Form-5
Pack size & Demanded Price 5ml, 10ml, 13.5ml & 15ml; As per PRC
Me-too status (with strength and dosage CROMO-STULLN UD EYE DROPS of M/s Haroon
form) Brothers, Karachi (Reg.#045720)
on 16-02-2018, concluding satisfactory level of compliance
with cGMP guidelines as of today.
Remarks of the EvaluatorII Firm has sterile Drops (ophthalmic, Ear & Nose) section as
per submitted GMP inspection report.
22. Name and address of manufacturer / "M/s Avant Pharmaceuticals. M-028 H.I.T.E, Lasbela,
Applicant Balochistan"
Brand Name +Dosage Form + Strength G-pentin 300mg Capsule
Gabapentin…300mg"
Pharmacological Group Anti-epileptic
Type of Form Form-5
Me-too status (with strength and dosage Gababion 300mg Capsules of M/s Merck Marker, Karachi
form) (Reg.#045346)
―All the observations pointed out during the inspection were
discussed with management and they assured for early
compliance. Overall rating of GMP was found good at the
time of inspection.‖
Decision:Approved.
Brand Name +Dosage Form + Strength G-pentin 100mg Capsule
Gabapentin…100mg"
Type of Form Form-5
Me-too status (with strength and dosage Gababion 100mg Capsules of M/s Merck Marker, Karachi
form) (Reg.#045345)
Decision:Approved.
Brand Name +Dosage Form + Strength Paradole 325/37.5 mg Tablets
Acetaminophen …… 325mg
Tramadol hydrochloride ……37.5mg"
Pharmacological Group Analgesic/Antipyretic
Type of Form Form-5
Me-too status (with strength and dosage Distalgesic Tablet by M/s Atco Lab. Karachi. (Reg#073865)
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Opin-F 6/25 mg Capsule
Olanzapine…6mg
Fluoxetine as hydrochloride…25mg"
Pharmacological Group Antipsychotic/Selective serotonin reuptake inhibitor
Type of Form Form-5
Me-too status (with strength and dosage Dipof 6/25 mg capsule by M/s Global Pharmaceuticals
form) (Reg#077900)

Decision:Approved.
26. Name and address of manufacturer / "M/s Pakistan Pharmaceutical Products Pvt. Ltd. D-122,
Applicant Sindh Industrial Trading Estate, Karachi"
Brand Name +Dosage Form + Strength Fonaz 15g Cream
Composition "Each gram contains:
Bifonazole…10mg/g (1% w/w)"
Pharmacological Group Anti-fungal
Type of Form Form-5
Pack size & Demanded Price 15gm; As per PCA
Me-too status (with strength and dosage Mecze Cream by M/s Epoch Pharmaceuticals, Karachi
form) (Reg#045341)
on 01-10-2018, concluding good level of GMP compliance at
the time of inspection.
Brand Name +Dosage Form + Strength Mycotrim 10g Cream
Composition "Each gram Contains:
Clotrimazole ……. 10mg "
Type of Form Form-5
Pack size & Demanded Price As per PCA
Me-too status (with strength and dosage Benestine Cream 1% by M/s Searle IV Solutions (Pvt.) Ltd,
form) Karachi (Reg#078619)
Decision:Approved.
Brand Name +Dosage Form + Strength Fuzid Cream
Fusidic Acid…20mg"
Pharmacological Group Antibiotic
Type of Form Form-5
Approval status of product in Reference Fucidin H cream of M/s LEO Laboratories Limited, approved
Regulatory Authorities by MHRA of UK
Me-too status (with strength and dosage Mirazym Cream of M/s Hiranis Karachi (Reg.# 076516)
form)
Decision:Approved.

Brand Name +Dosage Form + Strength Virolex Ointment
Composition "Each Gram Contains:
Acyclovir…0.05gm "
Pharmacological Group Anti-viral
Type of Form Form-5
Me-too status (with strength and dosage Virolite Ointment 5 % M/s Pearl Pharmaceuticals (Reg.#
form) 072032)
Decision:Approved.
30. Name and address of manufacturer / "M/s Searle IV Solutions Pvt Ltd. 1.5 km, Manga Raiwind
Applicant Road, Lahore"
Brand Name +Dosage Form + Strength Aqua Mac 10ml Injection
Composition "Each Ampoule Contains:
Sterile Water for Injection ….…10ml"
Pharmacological Group Sterile pharmaceutical solvent & Diluting agent
Type of Form Form-5
Pack size & Demanded Price 10ml x 1‘s & 100‘s; As per SRO
Me-too status (with strength and dosage Water for Injection by M/s Pulse Pharmaceuticals
form) (Reg#069217)
GMP status GMP Certificate issued on 15-03-2018.

Decision:Approved.
Brand Name +Dosage Form + Strength Levosearl 500mg Tablet
Levofloxacin as Hemihydrate…500mg"
Pharmacological Group Fluoroquinolones, Antibiotic
Type of Form Form-5
Pack size & Demanded Price 10‘s; Rs. 1095/-
Approval status of product in Reference Levofloxacin Tablets 500mg of M/s Actavis Group United
Regulatory Authorities Kingdom (MHRA Approved)
Me-too status (with strength and dosage Leflox Tablets 500mg of M/s Getz Pharma
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Levosearl 250mg Tablet

Levofloxacin as Hemihydrate…250mg"
Pharmacological Group Fluoroquinolones, Antibiotic
Type of Form Form-5
Regulatory Authorities (MHRA Approved)
Me-too status (with strength and dosage Leflox Kingdom Tablets 250mg of M/s Getz Pharma
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Tcosmid 50mg Tablet
Composition "Each film coated tablet Contains:
Lacosamide…50mg"
Type of Form Form-5
Me-too status (with strength and dosage Lacolep by M/s Hilton (Reg.#073857)
form)
Lacosamide…100mg"
Type of Form Form-5
Approval status of product in Reference Vimpat oral tablet of UCB Inc, USFDA
Me-too status (with strength and dosage Lacolep tablet of Hilton Pharma (Reg # 073858)
form)
II
Lacosamide…150mg"

Type of Form Form-5
Approval status of product in Reference Vimpat 150mg Tablet of UCB, approved by USFDA
Me-too status (with strength and dosage Lacolep of M/s Hilton (Reg.#073859)
form)
II
Brand Name +Dosage Form + Strength VD3 Capsule
Cholecalciferol (Vitamin D)…50,000 IU Eq. to 1mg"
Pharmacological Group Vitamin D3 analogue
Type of Form Form-5
30‘s; Rs. 240/-
Approval status of product in Reference Vitamin D capsule approved by USFDA
form)
Remarks of the EvaluatorII  Evidence of applied formulation/drug already approved
 Evidence of approval of applied formulation in reference
Registration Board in its 275th meeting, since submitted
reference by firm contains ―Ergocalciferol‖ instead of
―Cholecalciferol‖.
Decision:Deferred for following:
 Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were declared/approved by the Registration Board
37. Name and address of manufacturer / "M/s Welmark Pharmaceuticals. Plot #122 Phase 5, Block B,
Applicant Industrial Hattar"
Brand Name +Dosage Form + Strength Artimark 120mg Dry Injection
Composition "Each vial contains:
Artesunate sterile powder……120mg"
Pharmacological Group Antimalarial
Type of Form Form-5
Finished product Specifications IP
Pack size & Demanded Price As fixed by Government
Approval status of product in Reference WHO prequalified formulation
Me-too status (with strength and dosage Gen-M Injection by M/s Genix Pharma Karachi
form) (Reg#076073)
on 04-09-2018 & 26-09-2018, recommending renewal of
DML
Decision:Approved.
Brand Name +Dosage Form + Strength Schizomark 25mg Tablet
Quetiapine as Fumerate…25mg"
Pharmacological Group Antipsychotic
Type of Form Form-5
Pack size & Demanded Price 10‘s & 30‘s; As fixed by Government
Me-too status (with strength and dosage Quit 25mg Tablets of M/s Navegal Laboratories, (Reg.#
form) 068244)
DML
Remarks of the EvaluatorII Firm had initially applied for extended release tablets with
brand name of ―Quewel XR 25mg Tablet‖. Subsequently firm
has submitted revised formulation for film coated immediate
release tablets, as per the reference product, along with fee of
Rs. 5,000/- vide deposit slip# 1914553 dated 25-03-2019 for
revision of formulation.
Decision:Approved.
Brand Name +Dosage Form + Strength Quewel XR 100mg Tablet
Quetiapine as Fumerate…100mg"
Type of Form Form-5
Pack size & Demanded Price 10‘s & 30‘s; As fixed by Government
Me-too status (with strength and dosage Qusel tablet 100mg of M/s Hilton Pharma
form)
DML
Remarks of the EvaluatorII Firm had initially applied for extended release tablets with
brand name of ―Quewel XR 100mg Tablet‖. Subsequently
firm has submitted revised formulation for film coated
immediate release tablets, as per the reference product, along
with fee of Rs. 5,000/- vide deposit slip# 1914553 dated 25-
03-2019 for revision of formulation.
Decision:Approved.
40. Name and address of manufacturer / "M/s Sunrise Pharma Pvt Ltd. 594-A, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore contract manufacturing by
M/s Searle IV Solutions Pvt Ltd. 1.5 km, Manga Raiwind
Road, Lahore"
Brand Name +Dosage Form + Strength VD3 Injection

Composition "Each injection Contains:
Cholecalciferol (Vitamin D3)…200,000 IU Eq. to 5mg/ml"
Diary No. Date of R& I & fee Dy. No 9986 dated 16-03-2018 Rs.50,000/- Dated 15-03-
2018
Pharmacological Group Vitamin D analogue
Type of Form Form-5
Pack size & Demanded Price 5‘s; Rs. 145/- 30‘s; Rs. 725/- As per SRO
Approval status of product in Reference VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution for
Regulatory Authorities injection ANSM, France approved
Me-too status (with strength and dosage D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
form)
GMP status GMP Certificate issued on 15-03-2018 to M/s Searle IV
Solutions Pvt Ltd. 1.5 km, Manga Raiwind Road, Lahore
Decision:Approved.
41. Name and address of manufacturer / "M/s Perk Pharma Pvt Ltd. Plot # 197/1-B, Main Road,
Applicant Industrial Estate Gadoon, Sawabi, Kpk"
Brand Name +Dosage Form + Strength Percip 250mg Tablet
Ciprofloxacin as hydrochloride …250mg"
Type of Form Form-5
Pack size & Demanded Price As per DRAP Policy
Approval status of product in Reference Ciprofloxacin tablets 250mg of M/s Special Concept
Regulatory Authorities Development (UK MHRA Approved)
Me-too status (with strength and dosage Axcin Tablets 250mg of M/s Novartis Pharmaceuticals
form)
on 8/1/2018, concluding as under:
―All the observations in the inspection are discussed with the
firm. They are committed to rectify all the observations. The
firm may be considered to be operating in satisfactory level of
GMP compliance‖
Decision:Approved.
42. Name and address of manufacturer / "M/s Barrett Hodgson Pakistan Pvt Ltd. F/423, SITE,
Applicant Karachi"
Brand Name +Dosage Form + Strength Azibar 250mg Capsule
Azithromycin Dihydrate Eq. to Azithromycin…250mg"
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Pack size & Demanded Price 3‘s,;6‘s;10‘s;12‘s; As per DRAP‘s pricing Policy
Me-too status (with strength and dosage Zidor Capsule 250mg of M/s Winthrox Karachi . (Reg.#
form) 074943)
on 16th – 28th August, 2018, concluding as under:
―The firm has complied and addressed all the observations as
advised in the last inspection. Overall found satisfactory and
progressive towards good level of GMP compliance.‖
II
Decision:Approved.
Applicant Karachi"
Brand Name +Dosage Form + Strength Azibar 250mg Tablet
Type of Form Form-5
Pack size & Demanded Price 4‘s,;6‘s;10‘s; As per DRAP‘s pricing Policy
Me-too status (with strength and dosage Azitma 250mg Tablet of M/s Sami Karachi. (Reg.# 074899)
form)
Decision:Approved.
Applicant Karachi"
Brand Name +Dosage Form + Strength Azibar 500mg Tablet
Type of Form Form-5
Pack size & Demanded Price 2‘s;3‘s;6‘s;10‘s; As per DRAP‘s pricing Policy
form)
Decision:Approved.
Applicant Karachi"
Brand Name +Dosage Form + Strength Azibar 200mg/5ml Dry Suspension
Type of Form Form-5
Pack size & Demanded Price 15ml, 22.5ml,25ml,30ml; As per DRAP‘s pricing Policy
Me-too status (with strength and dosage Azitma 200mg/5ml dry suspension Tablet of M/s Sami
form) Karachi. (Reg.# 074902)
Decision:Approved.

46. Name and address of manufacturer / "M/s CherWel Pharmaceuticals Pvt Ltd. Plot # 20, Phase 4,
Applicant Hattar Industrial Estate, Hattar, Kpk"
Brand Name +Dosage Form + Strength Welfine 250mg Tablet
Terbinafine HCl …250mg"
Pharmacological Group Antifungal
Type of Form Form-5
Me-too status (with strength and dosage Neoterbin Tablets 250mg by M/s Neomedix Pharmaceuticals,
form) Islamabad. (Reg.# 081411)
GMP status Last GMP inspection was conducted on 4-2-2019 and panel
recommend the renewal of DML
Remarks of the EvaluatorII  In contrary to approved by the reference
agencies/authorities wherein the applied formulation is
approved as Terbinafine ―as hydrochloride‖ equal to
Terbinafine 250mg, while firm has applied for
Terbinafine hydrochloride equal to 250mg. Clarification
is required in this regard.
Decision: Deferred for submission of composition as per reference product.
Brand Name +Dosage Form + Strength Moncher 10mg Tablet
Montelukast as sodium …10mg"
Pharmacological Group Anti-asthmatic
Type of Form Form-5
Me-too status (with strength and dosage Montekast 10mg Tablets of M/s Global Pharmaceuticals.
form) (Reg.# 032154)
Decision:Approved.
Brand Name +Dosage Form + Strength Domwel 10mg Tablet
Domperidone Maleate Eq. to Domperidone…10mg"
Type of Form Form-5
Me-too status (with strength and dosage Kohidone 10mg Tablet of M/s Kohs Pharmaceuticals (Pvt)
form) Ltd. (Reg.# 070705)
II
Decision:Approved.
Brand Name +Dosage Form + Strength C-Moxit 400mg Tablet
Composition Each Film Coated Tablet Contains:
Moxifloxacin as hydrochloride...…400mg
Diary No. Date of R& I & fee Dy.No 10882 dated 26-03-2018 Rs.20,000/- 26-03-2018
Pharmacological Group Anti-biotic
Type of Form Form-5
Me-too status (with strength and dosage Swismox 400mg Tablet of M/s Swiss Pharma, Karachi.
form) (Reg.# 070659)
Decision:Approved.
50. Name and address of manufacturer / "M/s Wilson's Pharmaceuticals. 387-388, I-9, Industrial Area,
Applicant Islamabad"
Brand Name +Dosage Form + Strength Cardazin XR 500mg Tablets
Composition "Each Extended Release Film Coated Tablet Contains:
Ranolazine…500mg"
Pharmacological Group Anti-anginal
Type of Form Form-5
Me-too status (with strength and dosage Ranola Tablets 500mg of M/s. Highnoon Laboratories (Reg.#
form) 069039)
―Overall the firm was found to be operating at a very good
level of cGMP Compliance at the time of inspection‖
51. Name and address of manufacturer / "M/s Wilson's Pharmaceuticals. 387-388, I-9, Industrial Area,
Brand Name +Dosage Form + Strength Cardazin XR 1000mg Tablets
Ranolazine….…1000mg"
Pharmacological Group Anti-anginal
Type of Form Form-5
Me-too status (with strength and dosage Ranola Tablets 1000mg of M/s. Highnoon Laboratories
form) (Reg.# 069038)

II
52. Name and address of manufacturer / "M/s Semos Pharmaceuticals Pvt Ltd. Plot No.11, Sector 12-
Applicant A, North Karachi, Karachi, Pakistan"
Brand Name +Dosage Form + Strength Semorfen 200mg/5ml DS Suspension
Ibuprofen……200mg"
Type of Form Form-5
Pack size & Demanded Price As per PAC recommendation
Me-too status (with strength and dosage Brufen Suspension DS of M/s Abbott Karachi (Reg.# 070851)
form)
on 04-07-2018, Good GMP compliance level.
Decision:Approved.
Brand Name +Dosage Form + Strength Semorfen 200mg Tablet
Ibuprofen…….200mg"
Type of Form Form-5
Approval status of product in Reference Hedex Ibuprofen Tablets of M/s Omega Pharma Ltd.
Regulatory Authorities approved by MHRA of UK
Me-too status (with strength and dosage Suprofen Tablet 200mg of M/s Kohs Hyderabad (Reg.#
form) 070618)
Decision:Approved.
Brand Name +Dosage Form + Strength Semorfen 400mg Tablet
Type of Form Form-5
Approval status of product in Reference Ibuprofen Tablets 400mg of M/s Accord Healthcare Ltd.
Regulatory Authorities approved by MHRA of UK
Me-too status (with strength and dosage Suprofen Tablet 400mg of M/s Kohs Hyderabad (Reg.#
form) 070619)

Decision:Approved.
55. Name and address of manufacturer / "M/s Hiranis Pharmaceuticals Pvt Ltd. Plot No. E-145 to E-
Applicant 149, North Western Industrial Zone, Port Qasim, Karachi. "
Brand Name +Dosage Form + Strength Laderfex 120mg Tablet
Fexofenadine hydrochloride …… 120mg"
Pharmacological Group H1 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price As per PRC
Me-too status (with strength and dosage Fanoxin Tablets 120mg. of M/s Jawa Pharmaceutical (Pvt)
form) Ltd (Reg.# 052778)
GMP status The firm was last inspected on 29-01-2019, concluding that
firm is overall GMP compliant.
Decision: Approved with change of brand name.
Fexofenadine hydrochloride …… 180mg"
Type of Form Form-5
Me-too status (with strength and dosage Fexokure Tablets 180mg. of M/s English Pharm (Reg.#
form) 052411)
Fexofenadine hydrochloride..…60mg"
Type of Form Form-5
Me-too status (with strength and dosage Fanoxin Tablets 60mg. of M/s Jawa Pharmaceutical (Pvt)

Brand Name +Dosage Form + Strength Dentisept 0.15% w/v Mouthwash
Composition Each ml Contains:
Benzydamine Hydrochloride…0.15% w/v
Pharmacological Group NSAID/Analgesic
Type of Form Form-5
Me-too status (with strength and dosage Niflam Mouth Wash of M/s Platinum Pharmaceuticals (Pvt.)
II
Decision:Approved with change of brand name.
Brand Name +Dosage Form + Strength Dentisept-C Mouthwash
Benzydamine Hydrochloride…0.15% w/v
Chlorhexidine Gluconate…0.12% w/v
Pharmacological Group NSAID/Antiseptic
Type of Form Form-5
Approval status of product in Reference DIFFLAM-C SORE THROAT GARGLE & MOUTH
Regulatory Authorities SOLUTION + ANTISEPTIC solution approved by TGA of
Australia
Me-too status (with strength and dosage Benzaflam Solution of M/s Platinum Pharmaceuticals (Pvt.)
Decision:Approved with innovator‘s specification and with change of brand name
60. Name and address of manufacturer / "M/s Hilton Pharma Pvt Ltd. Plot No. 13-14, Sector 15,
Applicant Korangi Industrial Area, Karachi, Pakistan"
Brand Name +Dosage Form + Strength Hilomet 850mg Tablets
Metformin hydrochloride ….…850mg"
Pharmacological Group Anti-hyperglycemic
Type of Form Form-5
Pack size & Demanded Price 100‘s;30‘s;50‘s; as per DPC
Me-too status (with strength and dosage Glumet 850mg Tablet of M/s Swiss Pharma Karachi (Reg.#
form) 076070)

Decision:Approved.
Type of Form Form-5
Me-too status (with strength and dosage Glucotech 500mg Tablet of M/s Uni-Tiech Pharmaceuticals,
Decision: Approved.
Type of Form Form-5
Me-too status (with strength and dosage Glumet 1gm Tablet of M/s Swiss Pharma Karachi (Reg.#
form) 076071)
Decision: Approved.
Type of Form Form-5
Me-too status (with strength and dosage Glucotech 250mg Tablet of M/s Uni-Tiech Pharmaceuticals,
Decision: Approved.

Brand Name +Dosage Form + Strength Citihil 1000mg/4ml Injection
Composition "Each ml solution for Injection Contains:
Citicoline as Sodium…250mg‖
Pharmacological Group CNS stimulant
Type of Form Form-5
Pack size & Demanded Price 4ml ampoule;
1‘s;10‘s;5‘s; as per DPC
Approval status of product in Reference Citicolina Ferrer 1000 Mg Solucion Inyectable of M/s Ferrer
Regulatory Authorities Internacional, S.A. approved by AEMPS of Spain.
(https://cima.aemps.es/cima/publico/detalle.html)
Me-too status (with strength and dosage Citolin 4ml Injection of M/s Global Pharmaceuticals (Reg.#
form) 030541)
Composition Each ml solution for Injection Contains:
Citicoline as Sodium……50mg
Type of Form Form-5
Me-too status (with strength and dosage Not verifiable
form)
Decision:Deferred for following:
were declared/approved by the Registration Board
Brand Name +Dosage Form + Strength Citihil 500mg/5ml Oral Solution
Composition Each 5ml solution Contains:
Citicoline as Sodium…500mg
Type of Form Form-5
Pack size & Demanded Price 30ml, 60ml,120ml glass bottle; as per DPC
Approval status of product in Reference Approved by AEMPS of Spain.
Me-too status (with strength and dosage Cercolin Syrup of M/s Schazoo Laboratories (Reg.# 048985)
form)
Type of Form Form-5
Approval status of product in Reference Approved by ANSM of France
Me-too status (with strength and dosage Medicoline injection by M/s Mediceena Pharma (Reg.#
form) 047790)
II
Type of Form Form-5
Me-too status (with strength and dosage Coline Injection of M/s Neutro (Reg.#038828)
form)
Brand Name +Dosage Form + Strength Citihil 500mg Tablets
Citicoline as Sodium…500mg"
Type of Form Form-5

Me-too status (with strength and dosage Cercolin Tablets of M/s Schazoo Laboratories
form) (Reg.#048984)
Decision:Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275 thmeeting.
70. Name and address of manufacturer / "M/s Pearl Pharmaceuticals. Plot No. 204, Street No.1, I-10/3,
Brand Name +Dosage Form + Strength Futisone Lotion
Composition "Each 20ml Bottle Contains:
Fluticasone Propionate…0.05% w/v"
Pharmacological Group Corticosteroid
Type of Form Form-5
Approval status of product in Reference Aproved by USFDA
Me-too status (with strength and dosage Ticovate Lotion of Saffron Pharma (Reg# 067826)
form)
on 19-02-2017, recommending grant of GMP certificate.
Decision: Approved with USP specifications.
71. Name and address of manufacturer / "M/s Brookes Pharma Pvt Ltd. 58 & 59, Sector 15, Korangi
Applicant Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Pimporin 1g Injection
Composition "Each Vial Contains:
Cefepime HCL and Arginine Eq. to Cefepime…1gm"
Pharmacological Group Cephalosporin
Type of Form Form-5
Pack size & Demanded Price As per brand leader
Me-too status (with strength and dosage Nuxipim 1g Injection of Bosch
form)
GMP status GMP certificate valid till 07-05-2019
Decision:Approved.
Brand Name +Dosage Form + Strength Pimporin 2g Injection
Cefepime HCL and Arginine Eq. to Cefepime…2gm"
Diary No. Date of R& I & fee Dy.No 10667 dated 22-03-2018 Rs. 20,000/- 16-03-2018
Type of Form Form-5

Me-too status (with strength and dosage Feldopim 2 g Injection of M/s Wnsfeild Pharmaceutical,
form) (Reg.#075600)
Decision:Approved.
Brand Name +Dosage Form + Strength Pimporin 500mg Injection
Cefepime HCl and Arginine Eq. to Cefepime…500mg"
Type of Form Form-5
Me-too status (with strength and dosage Feldopim 500mg Injection of M/s Wnsfeild Pharmaceutical,
form) (Reg.#046970)
Decision: Approved
74. Name and address of manufacturer / "M/s Trigon Pharmaceuticals Pvt Limited. 8 km, Thoker
Applicant Raiwind Road, Lahore"
Brand Name +Dosage Form + Strength Lowstatin 20mg Tablets
Rosuvastatin as calcium……20mg"
Pharmacological Group Cholestrol lowering medicine
Type of Form Form-5
Pack size & Demanded Price 1 x 10‘s; Rs. 300/-
Me-too status (with strength and dosage Rosunext Tablets 20mg by M/s Novamed Pharma. (Reg.#
form) 064848)
Based on the areas inspected, the people met and documents
reviewed, and considering the findings of the inspection M/s
Trigon Pharmaceuticals Pvt. Ltd Lahore was considered to be
operating at Satisfactory level of compliance with
CGMPguidelines as per DRUGS ACT, 1976 and rules framed
there under at the time of inspection.
Recommendations:
The observation of the Inspection as highlighted in bold italic
font were discus with management at length. The
management expressed very firm commitment for earlier
compliance to the suggestions for further approving of GMP‖
Remarks of the EvaluatorII  In contrary to reference product, which is available as
film coated tablet, you have applied for film uncoated
tablet.
 Salt form of API is not mentioned in Form-5.
 Upon communication of above observation firm has
submitted revised Form-5 for film coated tablets along
with fee of Rs. 5,000/- for revision of formulation vide
deposit slip# 1911514 dated 08-05-2019.
Decision: Approved.
Domwel 10mg Tablet Teragon 2mg Tablet
Terazosin as hydrochloride dihydrate …… 2mg"
Pharmacological Group Alpha-adrenoreceptor antagonists
Type of Form Form-5
Me-too status (with strength and dosage Hyzosin Tablet 2mg by M/s English Pharm. (Reg.# 068007)
form)
Remarks of the EvaluatorII In contrary to reference product approved by MHRA of UK,
film coated tablet.
Upon communication of above observation firm has
submitted revised Form-5 for uncoated tablets along with fee
of Rs. 5,000/- for revision of formulation vide deposit slip#
1911517 dated 08-05-2019.
Decision: Approved.
Brand Name +Dosage Form + Strength Teragon 5mg Tablet
Terazocin as hydrochloride …… 5mg"
Pharmacological Group Alpha-adrenoreceptor antagonists
Type of Form Form-5
Me-too status (with strength and dosage Hyzosin Tablet 5mg by M/s English Pharm. (Reg.# 068003)
form)
Remarks of the EvaluatorII In contrary to reference product approved by MHRA of UK,
film coated tablet.
Upon communication of above observation firm has
submitted revised Form-5 for uncoated tablets along with fee
of Rs. 5,000/- for revision of formulation vide deposit slip#
1911515 dated 08-05-2019.
Decision: Approved.
Brand Name +Dosage Form + Strength Azigon 250mg Tablet
Composition "Each film coated tablet contains:
Azithromycin as dihydrate ……. 250mg"
Type of Form Form-5
Me-too status (with strength and dosage Prizocin Tablets 250 mg by M/s Nimrall Pharmaceuticals.
form) (Reg.# 066683)
Decision: Approved.
Brand Name +Dosage Form + Strength Pepgon 40mg Tablet
Composition "Each enteric coated tablet Contains:
Esomeprazole as magnesium trihydrate…..… 40mg"
Pharmacological Group Proton pump inhibitor
Type of Form Form-5
Me-too status (with strength and dosage Esoton-40mg Tablet by M/s Hygeia Pharmaceuticals,
form) Islamabad. (Reg.# 081204)
Remarks of the EvaluatorII Firm has submitted Rs. 5,000/- fee vide deposit slip# 1911518
dated 08-05-2019 for revision of formulation, since salt form
of API was not previously mentioned.
Decision: Approved with innovator‘s specifications.
Brand Name +Dosage Form + Strength Risgon 1mg Tablets
Risperidone ……1mg"
Pharmacological Group Antipsychotics
Type of Form Form-5
Me-too status (with strength and dosage Tablet Resjun -1 of M/s Jupiter PharmaPlot # 25, St# S6
form) RCCI, Rawat Islamabad. (Reg.# 081921)
Decision: Approved.
Brand Name +Dosage Form + Strength Risgon 2mg Tablet
Type of Form Form-5

Decision: Approved.
Brand Name +Dosage Form + Strength Risgon 3mg Tablet
Type of Form Form-5
Me-too status (with strength and dosage Becalm 3mg Tablet of M/s Maple Pharmaceuticals, Karachi
form) (Reg.# 058206)
Decision: Approved.
Brand Name +Dosage Form + Strength Trimantin 10mg Tablet
Memantine as hydrochloride….…10mg"
Pharmacological Group Psychoanaleptics
Type of Form Form-5
Me-too status (with strength and dosage Namentec 10mg Tablet of M/s Pharmatech Karachi (Reg.#
form) 075937)
Decision: Approved.
Brand Name +Dosage Form + Strength Trilepsi 250mg Tablet
Levetiracetam…….250mg"
Pharmacological Group Second generation antiepileptic
Type of Form Form-5
Me-too status (with strength and dosage Keppra Tablets 250mg by M/s AGP (Pvt.) Ltd, Karachi (Reg.
form) No. 045684)

Decision: Approved.
Brand Name +Dosage Form + Strength Triamloval 5/80 mg Tablet
Amlodipine as besylate ….. 5mg
Valsartan ……. 80mg "
Pharmacological Group Calcium channel blocker/Angiotensin-II receptor blocker
Type of Form Form-5
Me-too status (with strength and dosage Exforge Tablet of M/s Novartis Pharma (Reg.#047569)
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Triamloval 10/160 mg Tablet
Amlodipine as besylate ……10mg
Valsartan ….…160mg"
Pharmacological Group Calcium channel blocker/Angiotensin-II receptor blocker
Type of Form Form-5
Approval status of product in Reference Approved in US-FDA
Me-too status (with strength & dosage form) Co-Valzaar 10mg/160mg Tablet of Vision Pharmaceuticals.
Decision: Approved.
Brand Name +Dosage Form + Strength Trigem 320mg Tablet
Gemifloxacin as mesylate ……320mg"
Type of Form Form-5
Me-too status (with strength and dosage Gatiking 320 mg tablets of M/s Welwrd Pharmaceuticals
form) (Reg.# 078481)
Decision: Approved.

Brand Name +Dosage Form + Strength Trilepsi 500mg/5ml Injection
Levetiracetam ……100mg"
Type of Form Form-5
Pack size & Demanded Price 5ml ampoule x 1‘s; Rs. 315/-
Approval status of product in Reference Desitrend 100 mg/ml concentrate for solution for infusion of
Regulatory Authorities M/s Desitin Pharma Ltd. approved by MHRA of UK.
(https://www.medicines.org.uk/emc/product/7345/smpc)
Me-too status (with strength and dosage Eplipsa 500mg/5ml Injection of M/s Helix Karachi
form) (Reg.#075918)
Decision: Approved with Innovator‘s specifications.
Brand Name +Dosage Form + Strength Ttrifer 50mg/ml Injection
Iron (III) isomaltoside 1000 eq. to elemental Iron …… 50mg
Pharmacological Group Iron parenteral preparation
Type of Form Form-5
Pack size & Demanded Price 2ml ampoule x 5‘s; Rs. 2700/-
Approval status of product in Reference Diafer 50 mg/ml solution for injection of Pharmacosmos UK
Regulatory Authorities Limited. approved by MHRA of UK.
(https://www.medicines.org.uk/emc/product/5324/smpc)
Me-too status (with strength and dosage Not available.
form)
Remarks of the EvaluatorII  Evidence of applied formulation/drug in the applied fill
volume of 2ml, already approved by DRAP (generic / me-
too status) alongwith registration number, brand name
and name of firm.
Decision: Deferred for evidence of applied formulation/drug in the applied fill volume of 2ml,
already approved by DRAP (generic / me-too status) alongwith registration number, brand name
and name of firm.
89. Name and address of manufacturer / "M/s Trigon Pharmaceuticals (Pvt) Limited, 8 km, Thoker
Brand Name +Dosage Form + Strength Piroxigon-B 20mg Tablet
Piroxicam β-Cyclodextrin …… 20mg "
Type of Form Form-5
Me-too status (with strength and dosage Achway Tablets of M/s Getz Pharma (Reg.#047355)
form)

Decision: Approved.
Levetiracetam……750mg"
Type of Form Form-5
Approval status of product in Reference USFDA approved
Me-too status (with strength and dosage Saveta 750mg Tablets of Getz Pharma Karachi. (Reg.#
form) 081079)
Decision: Approved.
Brand Name +Dosage Form + Strength Dexifen 400mg Tablet
Dexibuprofen……400mg"
Type of Form Form-5
Me-too status (with strength and dosage Dexwel Tablets of M/s Welwrd Pharmaceutical.
form) (Reg.#076813)
Decision: Approved with innovator‘ sspecifications.
Brand Name +Dosage Form + Strength Trixetine 20mg Tablet
Paroxetine as hydrochloride……..20mg"
Pharmacological Group Anti-depressant
Type of Form Form-5
Me-too status (with strength and dosage Paroxiwel 20 mg Tablets of M/s Welwrd Pharmaceutical.
form) (Reg.#075517)
Decision: Approved.

Brand Name +Dosage Form + Strength Clozagon 25mg Tablet
Composition "Each Tablet contains:
Clozapine……25mg"
Pharmacological Group Anti-psychotics
Type of Form Form-5
Pack size & Demanded Price 5 x 10‘s; Rs.780/-
Me-too status (with strength and dosage Clogen Tablets 25 mg of M/s Genera Pharmaceuticals.
form) (Reg.#069989)
Decision: Approved.
Brand Name +Dosage Form + Strength Azigon 500mg Tablet
Azithromycin as dihydrate……500mg"
Type of Form Form-5
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Olan-T 3/25 mg Tablet
Olanzapine..........…....3mg
Fluoxetine…................25mg
Pharmacological Group Antipsychotic /Antidepressants in combination with
psycholeptics
Type of Form Form-5
Approval status of product in Reference NA
Me-too status (with strength and dosage NA
form)

were adopted by the Registration Board in its 275 th meeting.
alongwith registration number, brand name and name of firm.
Brand Name +Dosage Form + Strength Tristron 8mg Tablet
Ondansetron as hydrochloride dihydrate …… 8mg"
Pharmacological Group Anti-emetics
Type of Form Form-5
Me-too status (with strength and dosage Ondonx Tablet of M/s Genix Pharma Karachi (Reg.#081451)
form)
II
Decision: Approved.
Brand Name +Dosage Form + Strength Apo-lowclot 75mg Tablet
Clopidogrel as bisulphite …….75mg
Aspirin……..............................75mg
Pharmacological Group Anti-emetics
Type of Form Form-5
Approval status of product in Reference Approved by TGA of Australia
Me-too status (with strength and dosage CoPlavix Tablets 75/75mg of M/s Sanofi Karachi.
form) (Reg.#075978)
Decision: Deferred for verification of innovator‘s product either plain or bi-layered tablet.
Brand Name +Dosage Form + Strength Daylong 10mg Tablet
Cetrizine hydrochloride…10mg"
Pharmacological Group Anti-histamine
Type of Form Form-5
Me-too status (with strength and dosage Serzine 10mg Tablets of M/s Qintar Pharmaceuticals, 14-A

form) S.I.E Lahore Road, Sargodha. (Reg.# 030644)
Brand Name +Dosage Form + Strength Clozagon 100mg Tablet
Clozapine…100mg"
Pharmacological Group Anti-psychotics
Type of Form Form-5
Me-too status (with strength and dosage Clogen Tablets 100 mg of M/s Genera Pharmaceuticals.
form) (Reg.#069990)
Decision: Approved.
Brand Name +Dosage Form + Strength Triamloplus 5/10 mg Tablet
Amlodipine as besylate…5mg
Atorvastatan as calcium……10mg"
Pharmacological Group Anti-hypertensive
Type of Form Form-5
Me-too status (with strength and dosage Caprisk Tablets 5/10mg of M/s. Wilshire Laboratories (Pvt)
II
Decision: Approved.
Brand Name +Dosage Form + Strength Triopram 10mg Tablet
Escitalopram as Oxalate……10mg"
Pharmacological Group Antidepressant
Type of Form Form-5
Me-too status (with strength & dosage Zavesca tablet 10mg of Getz Pharma. (Reg.#045279)
form)

Decision: Approved.
Brand Name +Dosage Form + Strength Anxietoline 50mg Tablet
Sertraline as hydrochloride…….50mg"
Pharmacological Group SSRI
Type of Form Form-5
Me-too status (with strength and dosage Yesme Tablet 50mg by M/s Metro Pharmaceuticals,
form) Islamabad. (Reg.#081674)
Decision: Approved with change of brand name
Brand Name +Dosage Form + Strength Triamloplus 10/20 mg Tablet
Amlodipine as besylate ..… 10mg
Atorvastatin as calcium ……20mg"
Type of Form Form-5
Me-too status (with strength and dosage Caprisk Tablet 10/20mg of M/s. Wilshire Laboratories (Pvt)
II
Decision: Approved.
Levetiracetam…….500mg"
Pharmacological Group Second generation antiepileptic
Type of Form Form-5
Me-too status (with strength and dosage Keppra Tablets 500mg by M/s AGP (Pvt.) Ltd, Karachi (Reg.
form) No. 045685)
Decision: Approved.

Brand Name +Dosage Form + Strength Lopgon 50/12.5 mg Tablet
Losartan potassium…50mg
Hydrochlorothiazide……12.5mg"
Pharmacological Group Antihypertensive
Type of Form Form-5
Me-too status (with strength and dosage Invase-H 50mg+12.5mg Tablets by M/s Sami
form) Pharmaceutical, Karachi (Reg. No. 044274)
Decision: Approved.
106. Name and address of manufacturer / "M/s Pacific Pharmaceuticals Limited. 30 km, Multan Road,
Applicant Lahore, Pakistan"
Brand Name +Dosage Form + Strength Pacivan-T 20/25 mg Tablets
Olmesartan Medoxomil…….20mg
Hydrochlorothiazide……..25mg"
Type of Form Form-5
Finished product Specifications Manufacturer specifications.
Pack size & Demanded Price 1 x 10‘s; As per the brand leader
Me-too status Olmetab –H tablets by M/s Wilson‘s Pharma (Reg.#077725)
on 22/02/2018, concluding good level of GMP compliance at
the time of inspection
Brand Name +Dosage Form + Strength Pacivan-T 40/12.5 mg Tablets
Olmesartan Medoxomil…40mg
Hydrochlorothiazide…12.5mg"
Type of Form Form-5
Pack size & Demanded Price 1 x 10‘s, 2 x 10‘s; As per the brand leader
Me-too status (with strength and dosage Olmetab –H tablets by M/s Wilson‘s Pharmaceuticals, (Reg.
form) No. 077723)

Brand Name +Dosage Form + Strength Pacigab 150mg Capsules
Composition "Each Hard Gelatin Capsule Contains:
Pregabalin…150mg"
Pharmacological Group Anti-epileptics
Type of Form Form-5
Pack size & Demanded Price 2 x 7‘s;As per the brand leader
Me-too status (with strength and dosage Gabica 150mg Capsule by M/s Getz Pharma (Reg#048724)
form)
II
Pregabalin…300mg"
Type of Form Form-5
form)
Pregabalin…100mg"
Type of Form Form-5
Me-too status Gabica 100mg Capsule by M/s Getz Pharma (Reg#047366)
Pregabalin.............…50mg"

Type of Form Form-5
Me-too status (with strength and dosage Gabica 50mg Capsules by M/s Getz Pharma, Karachi (Reg.
form) No. 048725)
II
Brand Name +Dosage Form + Strength Pacivan-A 20/5 mg Tablets
Amlodipine as Besylate…5mg"
Type of Form Form-5
Approval status of product in Reference Approved by MHRA
Me-too status (with strength and dosage Baritec-A 20/5mg Tablet by M/s Barret Hodgson, Karachi
form) (Reg. No. 081442)
Brand Name +Dosage Form + Strength Pacivan-A 40/5mg Tablets
Amlodipine Besylate…5mg"
Type of Form Form-5
Me-too status (with strength and dosage Baritec-A 40/5mg Tablet by M/s Barret Hodgson, Karachi
form) (Reg. No. 081443)
Brand Name +Dosage Form + Strength Trama 50mg Capsules
Tramadol hydrochloride…50mg"
Pharmacological Group Opiate analogue

Type of Form Form-5
Approval status of product in Reference Tramadol 50mg capsule by Milpharm Ltd, approved by
Regulatory Authorities MHRA of UK.
Me-too status (with strength and dosage Tramal capsule 50mg by Impex Plus Karachi (Reg#010170)
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Tizaxidine 2mg Tablets
Tizanidine as hydrochloride……2mg"
Pharmacological Group Centrally acting agent; muscle relaxant
Type of Form Form-5
Me-too status (with strength and dosage Xinasia Tablets by Med Asia Pharmaceuticals (Pvt) Ltd.
form) (Reg#078514)
Remarks of the EvaluatorII  In contrary to reference product which is approved as
Tizanidine hydrochloride equivalent to Tizanidine 2mg,
firm had initially applied for Tizanidine equal to 2mg.
submitted revised Form-5 with composition as per
reference product, with submission of fee of Rs. 5,000/-
vide deposit slip# 1916162 dated 25-03-2019 for change
of formulation.
Decision:Approved.
Pregabalin…75mg"
Type of Form Form-5
Approval status of product in Reference USFDA Approved
Me-too status (with strength and dosage Gabica by M/s Getz Pharma
form)
II
Brand Name +Dosage Form + Strength Trama 100mg Capsule
Composition "Each extended release capsule contains:

Tramadol hydrochloride…100mg"
2018
Pharmacological Group Opiate analogue
Type of Form Form-5
Approval status of product in Reference Conzip capsules approved by USFDA as Extended release
Regulatory Authorities capsules
Me-too status (with strength and dosage Zultra SR 100mg by M/s. Wilshire Laboratories (Pvt.) Ltd;
form) (Reg#080714)
Remarks of the EvaluatorII  In contrary to reference product approved by USFDA,
which is available as extended release capsule, firm had
initially applied for immediate release capsules.
Clarification shall be submitted in this regard.
of formulation.
Decision:Approved.
Brand Name +Dosage Form + Strength Phenadrin-P Tablets
Orphenadrine citrate…35mg
Paracetamol…….450mg"
Pharmacological Group Narcotic analgesic combination
Type of Form Form-5
Pack size & Demanded Price 1 x 10‘s, 2 x 10‘s, 2 x 12‘s, 3 x 10‘s, 5 x 10‘s, 10 x 10‘s;
As per the brand leader
Approval status of product in Reference Norgesic of M/s iNova Pharmaceuticals Australia Pvt. Ltd
Regulatory Authorities approved by TGA of Australia
Me-too status (with strength and dosage Rid-All Forte by M/s Stanley Pharma (Reg.#069786)
form)
Brand Name +Dosage Form + Strength Pacivan 20mg Tablets
Olmesartan Medoxomil…20mg"
2018
Pharmacological Group Angiotensin-II antagonist
Type of Form Form-5
Me-too status (with strength and dosage Olmeday tablets 20mg by M/s Werrick Pharmaceuticals, 216-
form) 217, I-10/3, Industrial Area, Islamabad (Reg.#075378)
Decision:Approved.
Brand Name +Dosage Form + Strength Pacivan 40mg Tablets
Olmesartan Medoxomil…40mg"
Pharmacological Group Angiotensin-II antagonist
Type of Form Form-5
Me-too status (with strength and dosage Olmeday tablets 40mg by M/s Werrick Pharmaceuticals, 216-
form) 217, I-10/3, Industrial Area, Islamabad (Reg.#075379)
Decision:Approved.
Brand Name +Dosage Form + Strength Tizaxidine 4mg Tablets
Tizanidine as hydrochloride…4mg"
Pharmacological Group Centrally acting agent; muscle relaxant
Type of Form Form-5
Me-too status (with strength and dosage SN Skelax 4 mg Tablets by M/s SNB Pharma (Pvt) Ltd.
form) (Reg#078413)
Remarks of the EvaluatorII  In contrary to reference product which is approved as
Tizanidine hydrochloride equivalent to Tizanidine 4mg,
firm had initially applied for Tizanidine equal to 4mg.
of formulation
Decision:Approved.
Brand Name +Dosage Form + Strength Tamalgesic-P Tablets
Composition "Each film Coated Tablet Contains:
Tramadol hydrochloride…37.5mg
Paracetamol…325mg"
Pharmacological Group Analgesic/ Opioid Analgesic
Type of Form Form 5

Approval status of product in Reference
Ultracet by Janssen (USFDA)
Me-too status (with strength and dosage Distalgesic Tablets by Atco laboratories, Karachi (R. No.
form) 073865)
Decision:Approved.
Brand Name +Dosage Form + Strength Imizine 25mg Tablets
Composition "Each Sugar Coated Tablet Contains:
Imipramine…25mg"
Pharmacological Group Non selective monoamine reuptake inhibitor
Type of Form Form 5
Approved by MHRA of UK
Me-too status (with strength and dosage Imral 25mg Tablets by Sayyed Pharmaceuticals (Pvt) Ltd
form) (Reg. No. 070379)
Decision:Approved.
124. Name and address of manufacturer / "M/s High-Q Pharmaceuticals. Plot No.224, Sector 23,
Applicant Korangi Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Thiosim 4mg Tablet
Thiocolchicoside….…4mg"
Pharmacological Group Muscle relaxant
Type of Form Form 5
Pack size & Demanded Price As per leader price
Approved by ANSM of France.
Me-too status (with strength and dosage
Wodnik 4mg Tablet of M/s Martin Dow (Reg.# 081138)
form)
on 10-04-2018, concluding an acceptable level of compliance
with good manufacturing practices for Pharma products
125. Name and address of manufacturer / "M/s High-Q Pharmaceuticals. Plot No.224, Sector 23,
Applicant Korangi Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Thiosim 4mg Capsule
Thiocolchicoside…4mg"
Type of Form Form 5
Pack size & Demanded Price As per leader price
Approval status of product in Reference Myoplege 4 mg capsule by Laboratories GENEVRIER SA
Regulatory Authorities (ANSM approved)

Me-too status (with strength and dosageMuscor 4mg Capsule by M/s Genome Pharmaceuticals Pvt.
form) Ltd.(Reg#046466)
Remarks of the EvaluatorII No USP or BP monograph is available for applied
formulation.
126. Name and address of manufacturer / "M/s Vision Pharmaceuticals. Plot # 22,23, Industrial
Applicant Triangle, Kahuta Road, Islamabad"
Brand Name +Dosage Form + Strength Vomiz 10mg Tablet
Domperidone……10mg"
Pharmacological Group Peripheral dopamine receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 5 x 10‘s; As per SRO
Approved by TGA of Australia
Me-too status (with strength and dosage Epodom 10mg Tablets of M/s Atlantic Pharmaceutical (Pvt.)
form) Ltd, (Reg.# 062326)
Remarks of the Evaluator II
 In contrary to reference product approved by TGA of
Australia which is available as film coated tablet, firm
had initially applied for uncoated tablet. Upon
communication of above observation firm has submitted
revised formulation for film coated tablets, along with fee
of Rs. 5,000 vide deposit slip# 0815680 dated 01-04-2019
Brand Name +Dosage Form + Strength Vomiz-V 12.72mg Tablet
Domperidone Maleate……12.72mg"
Pharmacological Group Peripheral dopamine receptor antagonist
Type of Form Form 5
Me-too status (with strength and dosage Motilium 10mg tablet of M/s Janssen-Cilag
form)
GMP status GMP certificate issued on 26-01-2018.
II
Decision:Approved.
128. Name and address of manufacturer / "M/s Vision Pharmaceuticals. Plot# 22,23, Industrial
Brand Name +Dosage Form + Strength Acuvis 37.5/325 mg Tablets
Tramadol hydrochloride…37.5mg
Paracetamol…325mg"
Pharmacological Group Analgesic/ Opioid Analgesic
Type of Form Form 5
Ultracet by Janssen (USFDA)
Me-too status (with strength and dosage Distalgesic Tablets by Atco laboratories, Karachi (R. No.
form) 073865)
Remarks of the EvaluatorII  In contrary to reference product which is available as film
coated tablet, firm had initially applied for uncoated
tablet. Clarification shall be submitted in this regard.
submitted revised formulation for film coated tablets,
along with fee of Rs. 5,000 vide deposit slip# 0815679
dated 01-04-2019
Decision:Approved.
Brand Name +Dosage Form + Strength Dimenate 50mg Tablet
Dimenhydrinate……50mg"
Type of Form Form 5
Pack size & Demanded Price 100‘s; As per SRO
Approved by MHRA of UK
Me-too status (with strength and dosage Mendate Tablets by Hicon Pharmaceuticals Peshawar (Reg.
form) No. 077430)
Decision:Approved.
Brand Name +Dosage Form + Strength Examic 500mg/5ml Injection
Composition "Each 5ml ampoule Contains:
Tranexamic acid…500mg"
Pharmacological Group Anti-Fibrinolytic
Type of Form Form-5
Pack size & Demanded Price As per SRO.
Approval status of product in Reference Cyklokapron 500mg Solution for Injection by M/s Pfizer
Regulatory Authorities Limited (MHRA approved )
Me-too status (with strength and dosage Traxacid Injection 500mg/5ml by M/s Asian Continental
form) (Reg#057866)
Decision:Approved.
Brand Name +Dosage Form + Strength Citap 100mg Tablet
Sitagliptin as phosphate monohydrate….…100mg"

Pharmacological Group Antidiabetic
Type of Form Form-5
Me-too status (with strength and dosage Gliptin Tablets of M/s Himont Pharma (Pvt.) Ltd, (Reg.#
form) 076858)
―Based on the areas inspected the document reviewed and
considering the finding of inspection M/s Aspin Pharma is
considered to be operating at satisfactory level of compliance
with respect to cGMP guidelines as per Drug Act 1976 and
DRAP Act 2012.‖
Decision:Approved.
Brand Name +Dosage Form + Strength Omilok 40/1100 mg Capsule
Omeprazole……40mg
Sodium Bicarbonate….…1100mg"
Pharmacological Group Proton pump inhibitor/Antacid
Type of Form Form-5
Me-too status (with strength and dosage Omsod 40 mg Capsules of M/s Reliance Pharma, (Reg.#
form) 072154)
Brand Name +Dosage Form + Strength Omilok 20/1100 mg Capsule
Omeprazole…20mg
Sodium Bicarbonate….…1100mg"
Type of Form Form-5
Me-too status (with strength and dosage Omsod 20 mg Capsules of M/s Reliance Pharma, (Reg.#
form) 072153)
Brand Name +Dosage Form + Strength Omilok 20/1680 mg Sachet
Omeprazole…20mg
Sodium Bicarbonate…1680mg"
Type of Form Form-5
Me-too status (with strength and dosage RISEK INSTA Powder by Getz Pharma (Pvt.) Ltd. (Reg.#
form) 058547)
Decision:Approved.
Brand Name +Dosage Form + Strength Omilok 40/1680 mg Sachet
Omeprazole…40mg
Sodium Bicarbonate…1680mg"
Type of Form Form-5
Me-too status (with strength and dosage Ruling + Sachet by M/s High-Q, Karachi. (Reg.# 070633)
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Urbifen 100mg Tablet
Flurbirpofen……100mg"
Type of Form Form-5
Approval status of product in Reference Approved by Health Canada
Me-too status (with strength and dosage Strefen Tablets of Healers Pharmaceuticals (Reg.# 069733)
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Urbifen 50mg Tablet
Flurbirpofen……50mg"

Type of Form Form-5
Approval status of product in Reference Approved by Health Canada
Me-too status (with strength and dosage Floriwel 50mg Tablets of M/s Welmark Pharmaceuticals
form) (Reg.# 064387)
Decision:Approved.
Brand Name +Dosage Form + Strength Asomox 400mg Tablets
Moxifloxacin Hydrochloride 436.37mg Eq. to
Moxifloxacin……...400mg"
Type of Form Form-5
Me-too status (with strength and dosage Metoxim 400mg Tablet by M/s Foray Pharmaceutical
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Citap-M 50/1000 mg Tablet
Sitagliptin as phosphate monohydrate……50mg
Metformin hydrochloride……1000mg"
Pharmacological Group Anti-diabetic agent and oral hypoglycemic
Type of Form Form-5
Finished product Specifications Manufacturer specification
Me-too status (with strength and dosage Sitamet tablet by M/s CCL Pharmaceuticals Pvt. Ltd.
form)
Brand Name +Dosage Form + Strength Citap-M 50/500 mg Tablet
Sitagliptin as phosphate monohydrate……50mg
Metformin hydrochloride……500mg"

Pharmacological Group Anti-diabetic agent and oral hypoglycemic
Type of Form Form-5
Me-too status (with strength and dosage Sitamet tablet by M/s CCL Pharmaceuticals Pvt. Ltd.
form)
141. Name and address of manufacturer / "M/s Zafa Pharmaceuticals Laboratories Private Limited.
Applicant L-1/B Block-22, Federal B industrial Area, Karachi"
Brand Name +Dosage Form + Strength Molac 10mg/ml Injection
Ketorolac Tromethamine…….10mg"
Type of Form Form-5
Pack size & Demanded Price 1ml; As per latest DPC
Approval status of product in Reference US-FDA Approved.
Me-too status (with strength and dosage Tromit Injection of Standpharm (Reg.# 049959)
form)
GMP status GMP certificate issued on 23-05-2018
Decision:Approved.
142. Name and address of manufacturer / "M/s Zafa Pharmaceuticals Laboratories Private Limited.
Applicant L-1/B Block-22, Federal B industrial Area, Karachi"
Brand Name +Dosage Form + Strength Molac 30mg/ml Injection
Ketorolac Tromethamine…30mg"
Type of Form Form-5
Pack size & Demanded Price 1ml; As per latest DPC
Approval status of product in Reference US-FDA Approved.
Me-too status (with strength and dosage Tromit Injection of Standpharm (Reg.# 049960)
form)
GMP status GMP certificate issued on 23-05-2018
II
Decision:Approved.
143. Name and address of manufacturer / "M/s Avant Pharmaceuticals (Pvt.) ltd., Karachi"
Applicant
Brand Name +Dosage Form + Strength Paroxiwel 20mg tablet
Paroxetine as hydrochloride hemihydrate….…20mg"
Diary No. Date of R& I & fee Dy. No 43820 dated 26-12-2018 (Duplicate dossier)
Rs.20,000/- Dated 03-11-2017 (Photocopy)
Type of Form Form-5 (Duplicate dossier)

Approval status of product in Reference Approved by MHRA of UK.
Me-too status (with strength and dosageNeoxetine Tablets 20mg of M/s Neomedix Pharmaceuticals,
form) Islamabad (Reg.# 081407)
on 20-2-2018, concluding overall rating of GMP good at the
time of inspection.
Remarks of the EvaluatorII The firm has submitted duplicate dossier and as per record
retrieved from R & I section forwarded by Reg-II section
dated 01-03-2019 (attached with dossier) initial submission
date of dossier has been verified as 09-11-2017 (Dy. No R&I
20499).
Decision:Approved. Registration Board further decided to verify fee challan as per decision of 285 th
meeting of Registration Board.
144. Name and address of manufacturer / "M/s Wellborne Pharmachem and Biologicals, Plot No.51/1 –
Applicant 52/1, Phase-II, Industrial Estate, Hattar."
Brand Name +Dosage Form + Strength Salino 0.9% injection
Composition "Each 5ml contains:
Sodium chloride….…45mg"
Diary No. Date of R& I & fee Dy. No R&I : 155 dated 16-06-2015 (Original dossier)
Dy. No R&I : 32408 dated 28-09-2018
Pharmacological Group Electrolyte
Pack size & Demanded Price 5ml: As fixed by Government
Me-too status (with strength and dosage Sacro Injection of Macter Intr. Karachi. (Reg.# 079756)
form)
on 27-06-2018, concluding that firm is operating under good
level of cGMP.
II
Remarks of the Evaluator The firm has submitted duplicate dossier and as per record
retrieved from R & I section forwarded by Reg-I section dated
04-03-2019 (attached with dossier) initial submission date of
dossier has been verified as 16-06-2015 (Dy. No R&I: 155).
Decision:Approved. Registration Board further decided to verify fee challan as per decision of
285thmeeting of Registration Board.
145. Name and address of manufacturer / "M/s Scilife Pharma (Pvt) Ltd, Plot No. FD-57/58-A-2,
Applicant Korangi Creek, Industrial Park (KCIP) Karachi." Contract
manufacturing by M/s Nabiqasim Industries Ltd, 17/24,
Korangi Industrial Area, Korangi Highway, korangi, Karachi.
Brand Name +Dosage Form + Strength Lomisec IV 40mg injection
Omeprazole sodium eq. to Omeprazole….…40mg"
Dy. No R&I : 38068 dated 19-11-2018
Finished product Specifications Innovator specifications

Me-too status (with strength and dosage RISEK 40MG injection by M/s Julphar Pakistan (Pvt) Ltd
form) (Reg#045617)
GMP status Scilife: GMP inspection dated 10-07-2018 concluding GMP
compliance level is rated as GOOD.
NabiQasim: GMP inspection dated 02-08-2018 concluding
that firm is operating at an acceptable level of compliance of
cGMP Requirements at the time of inspection.
II
Remarks of the Evaluator The firm has submitted duplicate dossier and as per record
retrieved from R & I section forwarded by Reg-I section dated
01-03-2019 (attached with dossier) initial submission date of
dossier has been verified as 08-09-2017 (Dy. No R&I:
14325).
Decision: Approved with innovator‘s specifications. Registration Board further decided to verify
fee challan as per decision of 285thmeeting of Registration Board.
146. Name and address of manufacturer / "M/s Wenovo Pharmaceuticals. Plot # 31& 32 Punjab Small
Applicant Industrial Estate Taxila Pakistan"
Brand Name +Dosage Form + Strength Wenvax XR 75mg Capsule
Composition "Each Extended Release Capsule Contains:
Venlafaxine as Hydrochloride…75mg"
Pharmacological Group Serotonin and nor epinephrine reuptake inhibitor
Type of Form Form-5
Me-too status (with strength and dosage Venflax XR 75mg Capsule by M/s Regal Pharmaceuticals
form) (Reg#081978)
GMP status GMP inspection dated 30-09-2018 & 29-10-2018 wherein
panel unanimously recommends the grant of GMP certificate.
 Source of pellets, along with stability studies data, GMP
II
certificate of supplier and differential fee in case of
import of pellets shall be submitted.
147. Name and address of manufacturer / "M/s Global Pharmaceuticals Pvt Ltd. Plot # 204-205,
Applicant Industrial Triangle, Kahuta Road, Islamabad"
Brand Name +Dosage Form + Strength Linzy 100mg/5ml Dry Suspension
Composition "Each 5ml of reconstituted suspension contains:
Linezolid……100mg"
Pharmacological Group Antibacterial
Type of Form Form-5
Pack size & Demanded Price 60ml; As per DRAP‘s pricing policy
Me-too status (with strength and dosage J-Linz dry powder for Suspension by M/s Jupiter Pharma
form) (Reg#081949)
GMP status GMP inspection dated 11 & 24-10-2018 wherein panel
unanimously recommends the grant of GMP certificate.
II
148. Name and address of manufacturer / "M/s Getz Pharma Pvt Ltd. 29-30/27, Korangi Industrial
Applicant Area, Karachi."
Brand Name +Dosage Form + Strength Saltra DPI Powder for Inhalation 50mcg+500mcg
Composition "Each capsule contains:
Salmeterol Xinafoate eq. to Salmeterol……50mcg
Fluticasone Propionate……500mcg"
Pharmacological Group Adrenergics in combination with corticosteroids or other
drugs, excluding Anticholinergics.
Type of Form Form-5
Approval status of product in Reference Advair diskus approved by USFDA
Me-too status (with strength and dosage Seretide Diskus 50/500mcg Powder For Inhalation of M/s
form) Glaxosmithkline Pakistan Limited, 35-Dockyard Road, West
Wharf, Karachi. (Reg.#074728).
GMP status GMP inspection dated 26-06-2018 wherein firm was
considered to be operating at an acceptable level of
compliance with GMP guidelines as of today.
 The applied formulation is approved in USFDA is supplied as a disposable purple plastic inhaler
containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-
protective foil.
Sr. Observations Response by Firm
#
i. Under standardized in vitro test Please refer to submitted finished product specification
conditions, ADVAIR DISKUS delivers wherein we have mentioned that Delivered-Dose
233mcg of fluticasone propionate and Uniformity should be as per USP monograph i.e.,
45mcg of salmeterol base per blister Saltra DPI delivers 233mcg of fluticasone propionate
from ADVAIR DISKUS when tested at a and 45mcg of salmeterol base per capsule when tested
flow rate of 60L/min. for 2 seconds at a flow rate of 60L/min. for 2 seconds.
while you have not submitted any label
claim for delivered dose
ii. In reference products referred by you, This is to bring to your kind attention that DRAP has
formulation is pre-dispensed in a foil already approved Salmeterol + Fluticasone
blister strips, whereas applied propionate DPI 50mcg + 250mcg in hard capsules in
formulation is primarily pre-dispensed in its 275th DRB Meeting for M/s Macter International
hard capsules. Justification shall be Ltd., Karachi with the brand name of Salmicort DPI
submitted for change in primary (Salmeterol + Fluticasone propionate) Capsules 50mcg
container closure system with respect to + 250mcg (extract attached).
compatibility of applied formulation with
In order to confirm the compatibility of applied
the hard gelatin capsule.
formulation with hard capsules, this is to inform you
that HMPC based capsule shell is inert in nature and
has no impact on formulation. Also, the primary
packaging of our applied product and reference
product is same i.e., Blister foil.
iii Clarification regarding intended This is to inform your good office that we have
. manufacturing area, since applied established a segregated facility for the manufacturing
formulation contains Fluticasone, which of Dry Powder Inhalers (DPI) Capsules. Layout of the
is a steroid. said facility has been approved by DRAP (copy of
approval letter attached). Further, we have requested
Central Licensing Division of DRAP for the
constitution of panel for the inspection of our newly
established Dry Powder Inhalers (DPI) manufacturing
facility (copy of request letter attached). We hereby
declared that after registration of ‗Saltra DPI‘, the said
product will be manufactured in our segregated DPI
manufacturing facility.

Decision: Deferred for further deliberation upon manufacturing requirement of applied
formulation.
149. Name and address of manufacturer / "M/s Getz Pharma Pvt Ltd. 29-30/27, Korangi Industrial
Applicant Area, Karachi."
Brand Name +Dosage Form + Strength Saltra DPI Powder for Inhalation 50mcg+250mcg
Salmeterol Xinafoate eq. to Salmeterol……50mcg
Fluticasone Propionate……250mcg"
Pharmacological Group Adrenergics in combination with corticosteroids or other
drugs, excluding Anticholinergics.
Type of Form Form-5
Approval status of product in Reference Advair diskus approved by USFDA
Me-too status (with strength and dosage Seretide Diskus 50/250mcg Powder For Inhalation of M/s
form) Glaxosmithkline Pakistan Limited, 35-Dockyard Road, West
Wharf, Karachi. (Reg. #074727).
GMP status GMP inspection dated 26-06-2018 wherein firm was
compliance with GMP guidelines as of today.
 The applied formulation is approved in USFDA is supplied as a disposable purple plastic inhaler
containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-
protective foil.
Sr. Observations Response by Firm
#
i. Under standardized in vitro test Please refer to submitted finished product
conditions, ADVAIR DISKUS delivers specification wherein we have mentioned that
465mcg of fluticasone propionate and Delivered-Dose Uniformity should be as per USP
45mcg of salmeterol base per blister monograph i.e., Saltra DPI delivers 233mcg of
from ADVAIR DISKUS when tested at a fluticasone propionate and 45mcg of salmeterol base
flow rate of 60L/min. for 2 seconds per capsule when tested at a flow rate of 60L/min.
while you have not submitted any label for 2 seconds.
claim for delivered dose
ii. In reference products referred by you, This is to bring to your kind attention that DRAP has
formulation is pre-dispensed in a foil already approved Salmeterol +
blistered strips, whereas applied Fluticasone propionate DPI 50mcg + 500mcg in
formulation is primarily pre-dispensed in hard capsules in its 275th DRB Meeting for M/s
hard capsules. Justification shall be Macter International Ltd., Karachi with the brand
submitted for change in primary name of Salmicort DPI (Salmeterol + Fluticasone
container closure system with respect to propionate) Capsules 50mcg + 500mcg (extract
compatibility of applied formulation with attached).
the hard gelatin capsules. In order to confirm the compatibility of applied
formulation with hard capsules, this is to inform you
that HMPC based capsule shell is inert in nature and
has no impact on formulation. Also, the primary
packaging of our applied product and reference
product is same i.e., Blister foil.
iii. Clarification regarding intended This is to inform your good office that we have
manufacturing area, since applied established a segregated facility for the
formulation contains Fluticasone, which manufacturing of Dry Powder Inhalers (DPI)
is a steroid. Capsules. Layout of the said facility has been
approved by DRAP (copy of approval letter
attached). Further, we have requested Central
Licensing Division of DRAP for the constitution of
panel for the inspection of our newly established Dry
Powder Inhalers (DPI) manufacturing facility (copy
of request letter attached). We hereby declared that
after registration of ‗Saltra DPI‘, the said product
will be manufactured in our segregated DPI
manufacturing facility.
Decision: Deferred for further deliberation upon manufacturing requirement of applied
formulation.
150. Name and address of manufacturer / "M/s Genome Pharmaceuticals Pvt Ltd. Plot # 16/I-Phase IV,
Applicant Industrial Estate, Hattar, KPK"
Brand Name +Dosage Form + Strength Ceclofin SR-200 Tablets
Composition "Each Sustained Release film coated Tablet Contains:
Aceclofenac……200mg"
Type of Form Form-5
Pack size & Demanded Price As recommended by the PRC
Approval status of product in Reference --
Me-too status (with strength and dosage Alkeris SR 200mg Tablet of Sami Pharmaceuticals, Karachi
form) (Reg. #061066).
GMP status GMP inspection dated 12/05/18 concluding that overall the
firm was operating under Good level of cGMP.
II
151. Name and address of manufacturer / "M/s Scotmann Pharmaceuticals. 5-D, I-10/3, Industrial Area,
Brand Name +Dosage Form + Strength Pekny 550mg Tablets
Rifaximin…550mg"
Pharmacological Group Antibiotics
Type of Form Form-5
Pack size & Demanded Price 2 x 5‘s, 10‘s ; As per SRO
Me-too status (with strength and dosage Rixago 550mg Tablet by M/s OBS Pharma Karachi
form) (Reg#081073)
GMP status GMP inspection dated 10-10-2018 & 17-10-2018 wherein the
panel unanimously recommends for grant of GMP certificate.
II
Brand Name +Dosage Form + Strength Pekny 200mg Tablets
Rifaximin…200mg"
Type of Form Form-5
Pack size & Demanded Price 2 x 5‘s, 10‘s ; As per SRO
Me-too status (with strength and dosage Normix Tablets by M/s Sanital Pharmaceutical Rawalpindi.
form) (Reg#022656)
II
Brand Name +Dosage Form + Strength Mozart 1mg/ml Oral Solution
Risperidone……1mg"
Type of Form Form-5
Me-too status (with strength and dosage Risperdal Oral Solution by M/s Johnson & Johnson Ltd
form) Karachi. (Reg.# 027396)
Decision: Approved.
154. Name and address of manufacturer / "M/s Medpharm Research Lab. 28 km, Ferozepur Road,
Applicant Lahore"
Brand Name +Dosage Form + Strength Medmox 400mg Tablets
Moxifloxacin as HCl……400mg"
Type of Form Form-5
Pack size & Demanded Price 5‘s; As recommended by PRC
Me-too status (with strength and dosage Navelox Tablets 400mg by M/s Navegal Laboratories (Reg#
form) 068237)
GMP status Last inspection dated 12-01-2018 for grant of new DML.
Panel recommends grant of new DML.
II
Decision:Approved.
155. Name and address of manufacturer / "M/s Saydon Pharmaceutical Industries (Pvt) Ltd, 77-A,
Applicant Hayatabad Industrial Estate, Peshawar"
Brand Name +Dosage Form + Strength Resperon 3mg Tablet
Risperidone…….3mg"
Type of Form Form-5

Me-too status (with strength and dosage Becalm 3mg Tablet of M/s Maple Pharmaceuticals, Karachi
form) (Reg.# 058206)
GMP status Last inspection dated 13-02-2018 concluding as under:
"Overall the firm was in good working condition and
following the cGMP guidelines as per Drugs Act, 1976 and
rules framed there under, Based on the area inspected the
people met and document reviewed and considering the
findings of Inspection of M/s Say don Pharmaceuticals Pvt.
Ltd Peshawar is considered at acceptable level of compliance
with CGMPguidelines as per Drugs Act, 1976 and rules
framed under."
(No of Recommendations written by Area FID in the detail
report after conclusion.)
Recommendations:
The management is advised to appoint fill time QA In charge
with sufficient experience and testing of their products,
according to Pharmacopeia methods. All the above points
discuss with the management and they are agreed to rectify at
their earliest. The HPLC operator and microbiologist need
training. The firm is further advised to purchase latest official
books. The firm is also directed to upgrade their SOPs for
―Sterility Testing" and arrange official strains of microbes for
media testing.‖
Decision: Deferred for updated status of GMP of the firm form QA & LT division as inspection
report submitted by firm does not conclude GMP compliant status.
156. Name and address of manufacturer / "M/s Saydon Pharmaceutical Industries Pvt Ltd. 77-A,
Risperidone…..4mg"
Type of Form Form-5
Me-too status (with strength and dosage Riss 4mg Tablet of M/s M/s Shawan Pharmaceuticals,
form) Islamabad (Reg.# 080376)
II
Brand Name +Dosage Form + Strength Sebixa 10mg Tablet
Memantine HCl….…10mg"
Type of Form Form-5

Me-too status (with strength and dosage Stir-UP 10mg Tablets of M/s Nabiqasim Pharmaceuticals
form) (Reg.# 047453)
Brand Name +Dosage Form + Strength Sebixa 20mg Tablet
Memantine HCl….…10mg"
Type of Form Form-5
Me-too status (with strength and dosage Rement 20mg Table of M/s High-Q Pharmaceuticals,
II
Brand Name +Dosage Form + Strength Topadon 25mg Tablet
Topiramate…..25mg"
Type of Form Form-5
Me-too status (with strength and dosage Engrax Tablets 100mg of M/s English Pharmaceuticals
form) Industries. (Reg.# 040144)
Type of Form Form-5

Brand Name +Dosage Form + Strength Damictal 50mg Tablet
Lamotrigine…….50mg"
Pharmacological Group Antiepileptic
Type of Form Form-5
Me-too status (with strength and dosage Sportin 50mg Tablets of M/s Fassgen Pharmaceuticals,
form) (Reg.# 070345)
Lamotrigine……25mg"
Type of Form Form-5
Me-too status (with strength and dosage Sportin 25mg Tablets of M/s Fassgen Pharmaceuticals,
form) (Reg.# 070344)
Type of Form Form-5

GMP status
Lamotrigine……100mg"
Type of Form Form-5
Me-too status (with strength and dosage Epicta 100mg Tablets of M/s Alina Combine Pakistan,
Topiramate……50mg"
Type of Form Form-5
Me-too status (with strength and dosage Engrax Tablets 100mg of M/s English Pharmaceuticals
form) Industries. (Reg.# 040144)
II
Brand Name +Dosage Form + Strength Zepidep 15mg Tablet
Mirtazapine Hemihydrate……15mg"
Pharmacological Group Antidepressants
Type of Form Form-5
Me-too status (with strength and dosage Mirton-15 Tablets of M/s Genome Pharmaceuticals (Pvt.)

Topiramate……100mg"
Type of Form Form-5
Me-too status (with strength and dosage Topamid 100mg Tablets of M/s Fassgen Pharmaceuticals,
form) (Reg.# 062311)
II
Brand Name +Dosage Form + Strength Deplam 50mg Tablet
Trazodone HCl Eq. to Trazodone…….50mg"
Type of Form Form-5
Me-too status (with strength and dosage Depzodon Tablets of M/s Shaheen Pharmaceuticals, (Reg.#
form) 040907)
Remarks of the EvaluatorII In contrary to reference product approved by USFDA, which
is available as uncoated tablet, firm had applied for film
coated tablet. Clarification shall be submitted in this regard.
 Updated status of GMP of the firm form QA & LT division as inspection report submitted
by firm does not conclude GMP compliant status.
 Submission of revised formulation as per reference product.
Brand Name +Dosage Form + Strength Perica 100mg Capsule
Pregabalin…….100mg"
Type of Form Form-5
Finished product Specifications Manufacturers specification

form)
Decision:Deferred for updated status of GMP of the firm form QA & LT division as inspection
Pregabalin…….75mg"
Type of Form Form-5
Approval status of product in Reference Lyrica Capsule by PF Prism
Regulatory Authorities (USFDA Approved)
Me-too status (with strength and dosage Gabica by Getz Pharma
form)
II
Pregabalin……25mg"
Type of Form Form-5
Approval status of product in Reference Lyrica Capsule by PF Prism
Me-too status (with strength and dosage Neugast 25mg Capsule by M/s S.J & G, Karachi
form) (Reg.#076771 )
Brand Name +Dosage Form + Strength Flow 0.4mg Capsule
Tamsulosin HCl 0.2% SR Pellets Eq. to Tamsulosin
HCl…….0.4mg"
Pharmacological Group 5-alpha reductase inhibitor
Type of Form Form-5

Me-too status (with strength and dosage M-Sol 0.4mg Capsule of M/s M/s Regal Pharmaceuticals
form) (Reg.#081977)
Remarks of the EvaluatorII  Source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of
import of pellets shall be submitted.
 Updated status of GMP of the firm form QA & LT division as inspection report submitted
 Source of pellets, along with stability studies data, GMP certificate of supplier and
differential fee in case of import of pellets shall be submitted.
173. Name and address of manufacturer / "M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km, GT Road
Applicant Khori Murredke, Sheikhupura"
Brand Name +Dosage Form + Strength Moxamic-A 100mg/ml Injection
Tranexamic acid…….100mg"
Pharmacological Group Haemostatic
Type of Form Form-5
Pack size & Demanded Price 5ml glass ampoule; As per PRC
Me-too status (with strength and dosage Tremic-500 Injection by M/s Fynk Pharma. (Reg.# 062678)
form)
GMP status GMP inspection dated 21-02-2018 concluding as under:
―Overall hygienic condition of firm is satisfactory at the
time of inspection. They were advised improve further their
documentation as mention in above. They agreed‖
Decision:Approved.
174. Name and address of manufacturer / "M/s Winthrox Laboratories Pvt Ltd. K-219/A, S.I.T.E, Super
Applicant Highway, Phase-II, Karachi, Pakistan"
Brand Name +Dosage Form + Strength Pentowin 40mg Tablets
Composition "Each delayed release Tablet Contains:
Pantoprazole as Sodium Sesquihydrate…40mg"
Type of Form Form-5
Pack size & Demanded Price 10‘s,20‘s,30‘s; As per SRO
Me-too status (with strength and dosage Cantrofast Tablets of M/s Candid Pharmaceuticals
form) (Reg.#082031)
GMP status GMP inspection dated 09-102018 concluding as under:
―All the observations noted during the inspections were
discussed with their CEO and technical persons for earlier
compliance. Based on above observations, documentations
reviwed and personnel met their overall GMP compliance
level is rated as good.
Decision:Approved.
Brand Name +Dosage Form + Strength Drozenel 10mg Tablet
Ebastine….…10mg"
Type of Form Form-5
Finished product Specifications JP
Approval status of product in Reference Approved by ANMS of France
Me-too status (with strength and dosage Clubex 10mg Tablets of M/s Welmark Pharmaceuticals.
form) (Reg.# 056446)
reviwed and personnel met their overall GMP compliance
Decision:Approved.
Brand Name +Dosage Form + Strength Maltin-F Oral Syrup
Iron III Hydroxide polymaltose complex Eq. to Elemental
Iron……..50mg
Folic Acid……..0.35mg"
Pharmacological Group Haematinic
Type of Form Form-5
Approval status of product in Reference N/A
Me-too status (with strength and dosage Irofin-F Syrup of M/s AlinaCombine Karachi. (Reg.#074893)
form)
Decision: Registration Board approved the case with innovator‘s specification, since iron
preparations are not considered as drug by various reference regulatory authorities.
Brand Name +Dosage Form + Strength Drozenel 20mg Tablet
Ebastine….…20mg"
Type of Form Form-5
Approval status of product in Reference Approved by Medicine Evaluation Board of Netherland.
Me-too status (with strength and dosage Lobastin Tablet 20mgTablets of M/s Lowitt Pharmaceutical
form) (Pvt) Ltd. (Reg.# 080844)
II
Decision:Approved.
Brand Name +Dosage Form + Strength Maltin-F Tablet
Composition "Each chewable Tablet Contains:
Iron III Hydroxide Polymaltose Complex Eq. to Elemental
Iron ……. 100mg
Folic Acid……0.35mg"
Pharmacological Group Anti-anaemic
Type of Form Form-5
Me-too status (with strength and dosage Ipomalt -F Tablets of M/s Rock Pharmaceutical Laboratories
form) (Pvt) Ltd. (Reg.# 077301)
Decision:Registration Board approved the case with innovator‘s specification, since iron
Brand Name +Dosage Form + Strength Rowin 250mg Tablet
Azithromycin…….250mg"
Pharmacological Group Macrolide Anti-biotic
Type of Form Form-5
Me-too status (with strength and dosage A-Mycin 250mg Tablets of M/s Alen Pharmaceuticals (Pvt.)
II
Decision:Approved.
Brand Name +Dosage Form + Strength Maltin Oral Drops
Iron III Hydroxide polymaltose complex Eq. to Elemental
Iron…50mg"
Type of Form Form-5
Me-too status RBC Oral Drops of M/s Genix Pharma (Reg.#076165)
Decision:Registration Board approved the case with innovator‘s specification, since iron

Brand Name +Dosage Form + Strength Examic 250mg/5ml Injection
Tranexamic acid…….250mg"
Pharmacological Group Antifibrinolytics
Type of Form Form-5
Pack size & Demanded Price 5ml x 10‘s;As per SRO
Approval status of product in Reference Transcermin Note 5% Injection by M/s Daiichi Sankyo
Regulatory Authorities Co., Ltd. (PMDA Japan Approved)
Me-too status (with strength and dosage Tremic-250 Injection by M/s Fynk Pharma. (Reg.# 062677)
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Dimenate 50mg Injection
Dimenhydrinate……50mg"
Pharmacological Group Antihistamines
Type of Form Form-5
Pack size & Demanded Price 1ml x 25‘s; As per SRO
Approval status of product in Reference Approved by Health Canada.
Me-too status (with strength and dosage Misvinate 50mg Injection by M/s Mission Karachi (Reg.#
form) 080319)
Decision:Approved.
Brand Name +Dosage Form + Strength Examic 250mg Capsule
Tranexamic acid……250mg"
Type of Form Form-5
Approval status of product in Reference Approved by PMDA of Japan
Me-too status (with strength and dosage Tranex 250mgCapsule by M/s Mission Karachi (Reg.#
form) 080311)
Decision:Approved.

Brand Name +Dosage Form + Strength Examic 500mg Capsule
Tranexamic acid……500mg"
Type of Form Form-5
Approval status of product in Reference Approved by Italian Medicine Agency
Me-too status (with strength and dosage Tranex 500mgCapsule by M/s Mission Karachi (Reg.#
form) 080310)
Decision:Approved.
Brand Name +Dosage Form + Strength Sert 100mg Tablet
Sertraline HCl Eq. to Sertraline…….100mg"
Pharmacological Group Selective serotonin reuptake inhibitor
Type of Form Form-5
Pack size & Demanded Price 3 x 10‘s; As per brand leader
Me-too status (with strength and dosage Ertalin 100 mg Tablets of M/s Genome Pharmaceuticals
form) (Reg.# 076845)
on 22/02/2018, concluding good level of GMP compliance at
Decision:Approved.
Brand Name +Dosage Form + Strength Phenadrin-P Forte 50/650 mg Tablets
Orphenadrine Citrate…….50mg
Paracetamol…..…650mg"
Pharmacological Group Narcotic analgesic combination
Type of Form Form-5
Pack size & Demanded Price 1 x 10‘s, 2 x 10‘s, 3 x 10‘s, 2 x 12‘s, 5 x 10‘s, 10 x 10‘s; As
per brand leader
Me-too status (with strength and dosage Orthoflex-D 50mg Tablet of M/s Noa Hemis Karachi (Reg.#
form) 075984)

Brand Name +Dosage Form + Strength Citolin 100mg Oral Solution
Citicoline Sodium Eq. to Citicoline…100mg"
Type of Form Form-5
Pack size & Demanded Price 30ml, 60ml; As per SRO
Approval status of product in Reference Approved by AEMPS of Spain.
Me-too status (with strength and dosage Cercolin Syrup of M/s Schazoo Laboratories (Reg.# 048985)
form)
reviewed and personnel met their overall GMP compliance
188. Name and address of manufacturer / "M/s Semos Pharmaceuticals Pvt Ltd. Plot No. 11, Sector 12-
Applicant A, North Karachi, Krachi-75850, Pakistan"
Brand Name +Dosage Form + Strength Vortox 20mg Tablet
Vortioxetine hydrobromide 25.42 Eq. to
Vortioxetine…20mg"
Type of Form Form-5
Me-too status (with strength and dosage Brintellix 20mg tablet by M/s Lundebeck
form)
GMP status GMP inspection dated 04-07-2018 concluding good GMP
compliance.
189. Name and address of manufacturer / "M/s Semos Pharmaceuticals Pvt Ltd. Plot No. 11, Sector 12-
Applicant A, North Karachi, Krachi-75850, Pakistan"
Brand Name +Dosage Form + Strength Vortox 10mg Tablet
Vortioxetine Hydrobromide 12.7 Eq. to Vortioxetine…10mg"
Type of Form Form-5
Me-too status (with strength and dosage Brintellix 10mg tablet by M/s Lundebeck
form)
GMP status GMP inspection dated 04-07-2018 concluding good GMP
compliance.
190. Name and address of manufacturer / "M/s Mission Pharmaceuticals Pvt Ltd. Plot No. A-94, SITE
Applicant Super Highway Karachi, Pakistan"
Brand Name +Dosage Form + Strength Elvox 250mg Tablet
Levofloxacin Hemihydarte Eq. to Levofloxacin …… 250mg"
Diary No. Date of R & I & fee Dy. No 12548 dated 05-04-2018 Rs.20,000/- 05-04-2018
Type of Form Form-5
Regulatory Authorities (MHRA Approved)
Me-too status (with strength and dosage Leflox Kingdom Tablets 250mg of M/s Getz Pharma
form)
GMP status Last GMP inspection was conducted on 24-09-2018 and the
report concludes good level of GMP compliance.
Remarks of the EvaluatorII  Scientific justification for using 5% overage of
Levofloxacin hemihydrate in the master formulation.
Decision:Deferred for scientific justification for using 5% overage of Levofloxacin hemihydrate in
the master formulation
191. Name and address of manufacturer / "M/s Mission Pharmaceuticals Pvt Ltd. Plot No. A-94, SITE
Applicant Super Highway Karachi, Pakistan"
Brand Name +Dosage Form + Strength Elvox 500mg Tablet
Levofloxacin Hemihydarte Eq. to Levofloxacin …… 500mg"
Type of Form Form-5
Regulatory Authorities Kingdom (MHRA Approved)
Me-too status (with strength and dosage Leflox Tablets 500mg of M/s Getz Pharma
form)
Remarks of the EvaluatorII  Scientific justification for using 5% overage of
Levofloxacin hemihydrate in the master formulation.
Decision:Deferred for scientific justification for using 5% overage of Levofloxacin hemihydrate in
the master formulation
192. Name and address of manufacturer / "M/s Dr. Raza Pharma. Road B-4, Plot No. 44-C, Industrial
Applicant Estate, Hayatabad, Peshawar"
Brand Name +Dosage Form + Strength Befine 100mg/5ml Suspension
Type of Form Form-5
Pack size & Demanded Price 90ml; (As per Govt. policy)
Me-too status (with strength and dosage Mefen 100mg Suspension of M/s Metro Pharmaceuticals
form) (Reg.# 082038)
GMP status Last inspection dated 24-01-2019 concluding satisfactory
cGMP compliance.
Decision:Approved.
Brand Name +Dosage Form + Strength Nocuf DM Syrup
Diphenhydramine HCl …… 5mg
Dextromethorphan HBr …… 6.25mg"
Pharmacological Group Antihistamine/Antitussive
Type of Form Form-5
Pack size & Demanded Price (As per Govt. policy)
Me-too status (with strength and dosageKufmed DM Syrup of M/s Fozan Pharmaceuticals (Pvt) Ltd
form) (Reg.# 074514)
cGMP compliance.
authorities/agencies which were adopted by the Registration Board in its 275thmeeting.
Brand Name +Dosage Form + Strength Sertax 50mg Tablets
Sertraline as Hydrochloride…..…50mg"
Pharmacological Group Selective serotonin reuptake inhibitors
Type of Form Form 5
Me-too status (with strength and dosage Ertalin 50 mg Tablets of M/s Genome pharmaceuticals,
form) (Reg.#076844)
cGMP compliance.
Decision:Approved.
Brand Name +Dosage Form + Strength Passulosin 0.4mg SR Capsule
Composition "Each Sustained Release Capsule Contains:
Tamsulosin Hydrochloride (as modified release
pellets)........................0.4mg
Source of pellets: ―M/s Spansules Formulations, Hyderabad,
India.
Rs. 80,000/- dated 22-04-2019
Pharmacological Group Alpha 1 adrenergic receptor blocker
Type of Form Form 5
Me-too status (with strength and dosage Uripro 0.4mg Capsule M/s Getz Pharma (Reg.#081040)
form)
cGMP compliance.
Brand Name +Dosage Form + Strength Tri-Fit Plus Tablets
Amlodipine as Besylate……10mg
Hydrochlorothiazide…12.5mg
Valsartan…….160mg"
Type of Form Form 5
Me-too status (with strength and dosage Sofvasc –HCT Tablet of Wilson‘s Pharmaceuticals, 387-388,
form) I-9, Sector, Industrial Area, Islamabad. (Reg.# 077749)
cGMP compliance.
Brand Name +Dosage Form + Strength Tri-Fit Tablets
Amlodipine as Besylate……5mg
Hydrochlorothiazide…….12.5mg
Valsartan……160mg"
Type of Form Form 5
Me-too status (with strength and dosage Aldric-H 5/160/12.5mg of M/s Martin Dow Ltd. Karachi.
form) (Reg.# 081152)
cGMP compliance.

Brand Name +Dosage Form + Strength Tri-Ase 20mg Tablets
Rosuvastatin as Calcium…20mg"
Type of Form Form-5
form) 064848)
cGMP compliance.
Decision:Approved.
Rosuvastatin as Calcium…10mg"
Type of Form Form-5
form) 064847)
cGMP compliance.
Decision:Approved.
Rosuvastatin Calcium…5mg"
Type of Form Form-5
Me-too status (with strength and dosage Rosat Tablets 5 mg by M/s Genera Pharma. (Reg.# 069984)
form)
cGMP compliance.
Decision:Approved.

Brand Name +Dosage Form + Strength Preleptic 75mg Capsule
Pregabalin…75mg"
Pharmacological Group Anti epileptic
Type of Form Form-5
form)
cGMP compliance.
Decision:Approved with innovator‘s specification and change of brand name.
Brand Name +Dosage Form + Strength Preleptic 50mg Capsule
Pregabalin…50mg"
Pharmacological Group Anti epileptic
Type of Form Form-5
form)
cGMP compliance.
Brand Name +Dosage Form + Strength Alzamantine 10mg Tablets
Memantine HCl…10mg"
Pharmacological Group Psychoanaleptics.
Type of Form Form-5
Me-too status (with strength and dosage Dmantin 10mg Tablets by M/s Genome Pharmaceuticals
form) (Reg.#056078)
cGMP compliance.

Brand Name +Dosage Form + Strength Neutral Plus Suspension
Simethicon…125mg"
Pharmacological Group Antacid & antiflatulent
Type of Form Form-5
Me-too status (with strength and dosageSimecrol Plus Suspension by M/s Hicon Pharmaceuticals
form) (Reg.#041459)
cGMP compliance.
Brand Name +Dosage Form + Strength Neutral Suspension
Simethicone…….25mg"
Pharmacological Group Antacid & antiflatulent
Type of Form Form-5
Me-too status (with strength and dosage Simecrol Suspension by M/s Hicon Pharmaceuticals
form) (Reg.#041458)
cGMP compliance.
Remarks of the Evaluator II
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
206. Name and address of manufacturer / "M/s S.J & G Fazul Ellahie Pvt Ltd. E-46, S.I.T.E. Karachi-
Applicant 75700"
Brand Name +Dosage Form + Strength Graber 120mg Capsule
Orlistat (as 50% w/w pellets) ……. 120mg"
Source of pellets: M/s Alphamed formulations, Pvt. Ltd, Sy.
No. 225, Sampanbole Village, Medchal-Malkajgiri District,
Telangana, India.
(Photocopy)
Pharmacological Group Anti-obesity
Type of Form Form-5
Pack size & Demanded Price 30‘s; As per DPC
Me-too status Orlovit capsules by M/s CCL Pharma (Reg.#046324)
GMP status Last inspection report dated 02/05/18 concluding as under:
―The firm has complied/improved according to the directions
of the FID. Panel was satisfied for the improvements under
taken by the firm to comply with the observations dated 12th
July 2017. Further the panel advised the firm to continue the
improvements process
Remarks of the EvaluatorII Stability data submitted by supplier for Orlistat pellets is not
as per Zone-IV A conditions.
Decision: Deferred for further deliberation upon stability data requirement for orlistat pellets.
Applicant Khori Murredke,Sheikhupura"
Brand Name +Dosage Form + Strength Moxamic-A 50mg/ml Injection
Tranexamic acid…50mg"
Pharmacological Group Fibrinolytic
Type of Form Form-5
Approval status of product in Reference Transcermin Note 5% Injection by M/s Daiichi Sankyo
Regulatory Authorities Co., Ltd. (PMDA Japan Approved)
Me-too status (with strength and dosage Traxacid 250mg/5ml Injection by M/s Asian Continental
form) (Reg#057865)
―Overall hygienic condition of firm is satisfactory at the
time of inspection. They were advised improve further their
II
Decision:Approved.
Brand Name +Dosage Form + Strength Metoprolol Tartrate 5mg/5ml Injection
Metoprolol Tartrate ……. 5mg"
Pharmacological Group Β-receptor blocker
Type of Form Form-5
Pack size & Demanded Price 5ml x 5‘s; As per PRC
Me-too status (with strength and dosage Metobar Injection by M/s Barret Hodgson
form) (Reg#076480)
―Overall hygienic condition of firm is satisfactory at the time
of inspection. They were advised improve further their
Decision:Approved.
Brand Name +Dosage Form + Strength Baligno Cartridge Injection
Composition "Each Catridge (1.8ml) Contains:
Lignocaine HCl …… 36mg
Epinephrine Bitartrate…0.0324mg"
Pharmacological Group Antiarrhythmatic & local anaesthetic
Type of Form Form-5
Pack size & Demanded Price Ra. 1352 per 1.8ml x 50‘s ampoules
Me-too status (with strength and dosage KWANG MYUNG LIDOCAINE HCL of M/s ALI Pharma
―Overall hygienic condition of firm is satisfactory at the time
of inspection. They were advised improve further their
Decision: Deferred for evidence of approval of required manufacturing facility for cartridge filling.
210. Name and address of manufacturer / "M/s Dyson Research Laboratories Pvt Ltd. 28 km Ferozepur
Applicant Road Lahore"
Brand Name +Dosage Form + Strength Timzi 2mg Tablets
Tizanidine as hydrochloride……2mg"
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Me-too status (with strength and dosage SN Skelax 2 mg Tablets by M/s SNB Pharma (Pvt) Ltd.
form) (Reg#078412)
GMP status Last inspection report 01-08-2017 with conclusion that Panel
Recommended issuance of GMP certificate to the firm.
II
Decision: Approved
211. Name and address of manufacturer / "M/s The Schazoo Zaka Pvt Ltd. Lahore, Kalalwala, Zaka ur
Applicant Rehman State, Plot No.1, 20-km Lahore-Jaranwala Road,
Shikhupura"
Brand Name +Dosage Form + Strength Desvenla XR 100mg Tablet
Composition "Each Extended Release tablet Contains:
Desvenlafaxine as Succinate ……. 100mg"
Type of Form Form-5
Pack size & Demanded Price Rs. 98 per tablet; 1 x 10‘s
Me-too status (with strength and dosage Desvel XR 100mg Tablet by M/s Hilton Pharma (Reg#070760)
form)
GMP status Last inspection report 01-08-2017 with conclusion that Panel
Decision:Approved.
212. Name and address of manufacturer / "M/s The Schazoo Zaka (Pvt) Ltd. Lahore, Kalalwala, Zaka
Applicant ur Rehman State, Plot No.1, 20-km Lahore-Jaranwala Road,
Shikhupura"
Brand Name +Dosage Form + Strength Desvenla XR 50mg Tablet
Composition "Each Extended Release tablet Contains:
Desvenlafaxine as Succinate ……. 50mg"
Type of Form Form-5
Pack size & Demanded Price Rs. 60 per tablet; 1 x 10‘s
Me-too status (with strength and dosage Desvel XR 50mg Tablet by M/s Hilton Pharma (Reg#070761)
form)
Decision:Approved.
213. Name and address of manufacturer / "M/s Kaizen Pharmaceuticals Pvt Ltd. E-127-129, North
Applicant Western Industrial Zone, Bin Qasim, Karachi"
Brand Name +Dosage Form + Strength Safestin 4mg Tablet
Pitavastatin Calcium Eq. to Pitavastatin…4mg"
Pharmacological Group HMG-CoA reductase inhibitor
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s,30‘s; As per PRC
Me-too status (with strength and dosage Pitalip Tablets 4mg by M/s Hilton Pharma (Reg#070657)
form)
GMP status Last inspection report 02-08-2018 concluding satisfactory
level of GMP compliance
Remarks of the EvaluatorII  JP monograph is available for applied formulation.
Decision: Approved with JP specifications and change of brand name.
Pitavastatin Calcium Eq. to Piotavastatin……1mg"
Type of Form Form-5
Me-too status Pitalip Tablets 1mg by M/s Hilton Pharma (Reg#070655)
 JP monograph is available for applied formulation.
II

Pitavastatin Calcium Eq. to Piotavastatin……2mg"
Type of Form Form-5
Me-too status (with strength and dosage Pitalip Tablets 2mg by M/s Hilton Pharma (Reg#070656)
form)
Remarks of the EvaluatorII  JP monograph is available for applied formulation.
Brand Name +Dosage Form + Strength Nimodin 30mg Tablet
Nimodipine……30mg"
Pharmacological Group Selective calcium channel blockers
Type of Form Form-5
Me-too status Uni-Pine 30mg tablet by M/s Uni-tech (Reg#048665)
Decision:Approved.
217. Name and address of manufacturer / "M/s Seraph Pharmaceuticals. Plot No. 210, Industrial
Brand Name +Dosage Form + Strength Sympta 20mg Capsule
Composition Each Hard Gelatin Capsule Contains:
Duloxetine Hydrochloride enteric coated pellets e.q to
Duloxetine…20mg"
Diary No. Date of R & I & fee Dy. No 6484 dated 21-02-2018 Rs. 20,000/- 21-02-2018
Type of Form Form 5
Pack size & Demanded Price 14‘s, As per PRC.
Approval status of product in Reference Cymbalta
Regulatory Authorities USFDA Approved.
Me-too status (with strength and dosage 073501; Swenta 20mg Capsule
form) M/s Martin Dow, Karachi.
GMP status GMP certificate issue don the basis of inspection conducted
on 11-0Source of pellets6-2018.
V

218. Name and address of manufacturer / M/s Bio Mark Pharmaceuticals, Plot No. 527-Sunder
Applicant Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Spasgo tablet 80mg/80mg
Composition Each sugar coated tablet contains:
Hydrated Phloroglucinol 80mg corresponding to anhydrous
Phloroglucinol….......62.233mg
Trimethylphloroglucinol….......80mg
Diary No. Date of R & I & fee Dy. No.14498; 11-09-2017; Rs.20,000/- (11-09-2017)
Pharmacological Group Anti-spasmodic
Type of Form Form-5
Finished product Specifications Innovator‘s specification
Pack size & Demanded Price 3x10‘; As fixed by Govt.
Approval status of product in Reference SPASFON (ANSM approved)
Me-too status (with strength and dosage Spasrid tablets of M/s Barret Hodgson (Reg.# 034743)
form)
GMP status GMP certificate issued on the basis of inspection conducted
on 16-08-2018.
Remarks of the EvaluatorV
219. Name and address of manufacturer / "M/s Genome Pharmaceuticals (Formerly Silver Oak) Plot
Applicant No.16//1, Phase No.4.4, Industrial Estate Area, Hattar Distt.
Haripur.‖
Brand Name +Dosage Form + Strength Qupin SR 300mg tablet
Composition "Each sustained release tablet contains:

Quetiapne as Fumarate ……… 300mg"
Dy. No R&I : 38068 dated 19-11-2018
Rs.8,000/- Dy. No. 746 dated 13-09-2011/-
Rs. 12,000/- Dy. No. 407 dated 28-11-2014 Dated 16-06-
2015 (Photocopy)
Pharmacological Group Psychotropic agent
Me-too status (with strength and dosage Ziapine-SR Tablets 300mg of M.s English Pharma
form) (Reg.#068002)
GMP status GMP inspection dated 12/05/18 concluding that overall the
firm was operating under Good level of cGMP.
Remarks of the EvaluatorII Deputy Director (R-IV) vide letter No. F.16-4/2013-Reg-IV
dated 26-12-2018 has stated that ―Firm could not produce the
verified copy for 8,000/- challan, the firm has again submitted
fee of Rs. 8,000/- vide challan no. 0811378 dated 21-12-2018.
The firm has verified copy of challan of Rs. 12,000/-
Decision:Approved. Fee verification shall be processed as per decision of registration Board.
220. Name and address of manufacturer / "M/s Innvotek Pharmaceuticals, Islamabad.‖
Applicant
Brand Name +Dosage Form + Strength Hydra Lubricant Eye drops
Composition "Each ml contains:
Sodium hyaluronate …….. 2mg"
Diary No. Date of R& I & fee Dy.No.(R&I):123 (08-11-2016), Rs. 20,000/- (08-11-2016)
Pharmacological Group Lubricant
Type of Form Form-5
Approval status of product in Reference Approved by TGA
Me-too status (with strength and dosage Hylo of M/s Helix Pharma (Reg.#067031)
form)
―Based on the areas inspected the people met and the
documents reviewed and considering the findings of the
inspection. M/s Noa Hemis Pharma located at Karachi is
compliance to the cGMP guidelines, however management
should put more focus on hiring of adequate qualified persons
for further up gradation and strengthens of technical
expertise.‖
Brand Name +Dosage Form + Strength Osteo-D 5mg/ml Injection
Cholecalciferol…5mg Eq. to 200,000 IU"
Diary No. Date of R& I & fee Dy. No 843 dated 05-01-2018 Rs. 20,000 Dated 05-01-2018
(Photocopy)
Pharmacological Group Vitamin D
Type of Form Form-5 (Duplicate)
Approval status of product in Reference VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution for
Regulatory Authorities injection ANSM, France approved
Me-too status (with strength and dosage D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
form)
on 01-10-2018, concluding good level of GMP compliance at
Decision: Approved with change of brand name. Fee shall be verified as per procedure adopted by
Registration Board.
222. Name and address of manufacturer / "M/s Wimits Pharmaceuticals (Pvt.) Ltd. Plot No. 129,
Applicant Sundar Industrial Estate, Raiwind Road, Lahore"
Brand Name +Dosage Form + Strength Valtra Tablet
Amlodipine as Besyate……10mg
Valsartan…320mg
Hydrochlorothiazide…25mg"
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per Drug pricing policy
Regulatory Authorities.
Me-too status Sofvasc –HCT Tablet of Wilson‘s Pharmaceuticals, 387-388,
I-9, Sector, Industrial Area, Islamabad. (Reg.# 077753)
Remarks of the Evaluator2

Decision: Approved.
Brand Name +Dosage Form + Strength Valtra-D Tablet
Amlodipine as Besyate…5mg
Valsartan…160mg
Type of Form Form-5
Me-too status Aldric-H 5/160/25mg Tablet of M/s Martin Dow Ltd.
Karachi (Reg.# 081148)
Decision: Approved.
Brand Name +Dosage Form + Strength Valtra-H Tablet
Amlodipine Besyate…10mg
Valsartan…160mg
Type of Form Form-5
Me-too status Sofvasc –HCT Tablet of Wilson‘s Pharmaceuticals, 387-388,
I-9, Sector, Industrial Area, Islamabad. (Reg.# 077753)
Decision: Approved.
b. Deferred cases
225. Name and address of manufacturer / M/s Pharma Lord (Pvt.) Ltd, 12Km, Lahore Road, Layyah.
Applicant
Brand Name +Dosage Form + Strength Slimax 120mg capsule
Composition Each capsule contains:
Orlistat IR pellets eq. to Orlistat….......120mg
Source of pellets: Vision Pharmaceuticals, Islamabad.
Diary No. Date of R& I & fee Dy. No.10017; 25-07-2017; Rs.20,000/- (25-07-2017)
Pharmacological Group Anti-obesity
Type of Form Form-5
Pack size & Demanded Price 1x10‘s; As per SRO
3x10‘s; As per SRO
10x10‘s; As per SRO
Approval status of product in Reference Xenical 120mg capsule (USFDA Approved)
Me-too status Orly capsule 120mg of M/s Rotex Medica Pakistan
GMP status 26-05-2017-Routine GMP Inspection; Firm is GMP compliant
Remarks of the Evaluator. ● Firm has submitted only real time stability study data
of three batches of pellets for 24 months.
Previous Decision: Registration Board in its 282nd meeting deferred for further
deliberation upon requirement of accelerated stability study
data of Orlistat pellets
Evaluation by PEC:  Firm has submitted declaration form M/s Vision
Pharmaceuticals (Pvt.) Ltd. as under:
―Orlistat melts at about 42oC and its formulation becomes
unstable at higher temperature so it‘s not suitable to perform
stability studies at accelerated conditions i.e., 40 + 2oC and
75% + 5%, due to this reason accelerated stability studies
for orlistat immediate release pellets is not being performed.
We are performing only real time stability studies (i.e., 30 +
2oC and 65% + 5%).
Decision: Deferred for further deliberation upon stability data requirement for orlistat pellets.
226. Name and address of manufacturer / M/s Hi-Med Pharmaceuticals. 208C Sunder Industrial Estate,
Applicant Lahore, Pakistan
Brand Name +Dosage Form + Strength Hicar 40/3360 mg Sachet
Composition Each sachet Contains:
Omeprazole…40mg
Sodium Bicarbonate…3360mg
Pharmacological Group Proton Pump Inhibitor/antacid
Type of Form Form-5
Pack size & Demanded Price As recommended by PRC
Me-too status Not verifiable
GMP status New DML on 13-06-2018
Remarks of the Evaluator.  Evidence of approval of applied formulation in reference
 Evidence of applied formulation/drug already approved by
Previous Decision: Registration Board in its 284th meeting Deferred for following:
 Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
declared/approved by the Registration Board in its
275th meeting.
 Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm
Evaluation by PEC:  Firm has submitted revised Form5 with following
composition:
―Each sachet Contains:
Omeprazole……40mg
Sodium Bicarbonate…1680mg‖
 Following me-too reference has been verified against
revised composition:
―Ruling + Sachet of M/s High-Q (Reg.#070633)‖
 Reference for revised formulation has also been verified
from USFDA.

 Firm has submitted fee of Rs. 20,000/- for revision of
formulation vide deposit slip# 0832240 dated 19-03-2019.
Decision: Approved with followimg composition:
―Each sachet Contains:
Omeprazole…….................40mg
Sodium Bicarbonate….....1680mg‖
227. Name and address of manufacturer / "M/s Treat Pharmaceutical Industry Pvt Ltd.
Applicant A-37, Small Industrial Estate, Township Kohat Road, Bannu"
Brand Name +Dosage Form + Strength Lanspro 30mg Capsule
Lansoprazole (as enteric coated pellets 8.5%
w/w).……..30mg"
Pharmacological Group Antipeptic ulcerant
Type of Form Form-5
Me-too status Leazole 30mg Capsules of M/s Leads Pharma (Pvt.) Ltd.
(Reg.#035891)
GMP status Last GMP inspection report dated 05/10/2017
Panel recommends DML renewal and additional sections
Remarks of the Evaluator.
Previous decision Registration Board in its 287th meeting deferred for source of
pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets
Evaluation by PEC Firm has submitted source of ―Lansoprazole 8.5% w/w enteric
coated pellets‖ from M/s Vision Pharmaceuticals, Pakistan.
Stability data for three batches of pellets has also been
submitted as per Zone-Iva conditions, form the M/s Vision
Pharmaceuticals, Pakistan.
Decision:Approved.
228. Name and address of manufacturer / M/s Novamed Pharmaceuticals (Pvt) Ltd., 28 KM, Ferozepur
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Tamflo Capsule
Tamsulosin hydrochloride (as SR pellets)…..0.4mg
Diary No. Date of R& I & fee Dy No. 1174: 15-10-2014 PKR 20,000/-: 02-10-2014
Pharmacological Group Selective alpha 1 receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 10‘s: As per SRO
Approval status of product in Reference Diffundox XL 400 microgram Capsules by Winthrop
Regulatory Authorities. Pharmaceuticals (MHRA Approved)
Me-too status Tamsolin capsule by Getz
GMP status GMP inspection conducted on 5th and 27th December 2017
with conclusive remarks that firm is compliant to good cGMP
at the time of inspection.
Remarks of the Evaluator. Source of pellets along with GMP of manufacturer, stability
study data of pellets is not submitted.
Previous decision Registration Board in its 287th meeting deferred the case for
further deliberation.
Evaluation by PEC Firm has submitted source of ―Tamsulosin hydrochloride SR
pellets 0.2%w/w‖ from M/s Vision Pharmaceuticals, Pakistan.
Stability data for three batches of pellets has also been
submitted as per Zone-IVA conditions, form the M/s Vision
Pharmaceuticals, Pakistan.
229. Name and address of manufacturer / M/s Zephyr Pharmatec Pvt. Ltd., A-39, S.I.T.E. II, Super
Applicant Highway, Karachi.
Brand Name +Dosage Form + Strength Acurax tablets 400mg
Composition Each tablet contains:
Doxofylline….......400mg
Pharmacological Group Bronchodilator
Type of Form Form-5
Finished product Specification Innovator‘s specifications
Pack size & Demanded Price 10‘s; As per PRC‘s price
Approval status of product in Reference Italian Medicine Agency (AIFA) Italy approved
Me-too status Profylline tablet 400mg of M/s Kaizen
GMP status Last inspection report conducted on 18-07-2017
concluding good level of GMP compliance.
Remarks of the Evaluator.  No official monograph of the applied formulation exists in
available editions of USP/BP/IP/JP.
 Original fee challan for Accurax 500mg tablets is attached
instead of Accurax 400mg tablets.
 Firm has revised formulation from film coated tablets to
uncoated tablets without submission of requisite fee.
Previous decision Registration Board in its 283rd meeting deferred for following:
 Original fee challan for applied formulation.
 Submission of fee for revision of formulation
Evaluation by PEC Firm has submitted that erroneously the strength of the product
in deposit slip had been mentioned as 500mg whereas the
correct strength of the product is 400mg.
Now the firm has submitted a new deposit slip of Rs. 20,000/-
with correct strength i.e., 400mg as a fee for the registration of
subject product vide deposit slip# 0825041 dated 01-04-2019.
Decision:Approved with innovator‘s specification
230. Name and address of manufacturer / M/s Festel Laboratories, Jinnah Industrial Estate, Link
Applicant Kattarband Road, Thokar Niaz Baig, Multan Road, Lahore
contract manufacturing by:
M/s. English Pharmaceutical Industries, Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road , Lahore
Brand Name +Dosage Form + Strength Esotac Injection 40mg
Composition Each vial contains:
Esomeprazole as sodium……40mg
Diary No. Date of R& I & fee 2132, 05-05-2016, Rs. 50,000/- (04-05-2016)
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Finished product Specification Innovator
Me-too status Nexum IV 40mg infusion of M/s Getz Pharma (Reg.#050651)
GMP status Not provided
Remarks of the Evaluator. Firm has submitted following documents:
 GMP certificate of M/s English Pharmaceuticals issued on
the basis of inspection conducted on 26-01-2018
 GMP inspection report of M/s Festel Laboratories
recommending renewal of DML conducted on 24-1-2016.
This inspection report is not conducted within a period of last

1 year.
 Form 5 signed by authorized and technical persons.
 After being deferred in 285th meeting of Registration Board,
the firm has submitted revised master formulation without
overage.
assessment and confirmation of manufacturing capacity of M/s.
English Pharmaceutical Industries, Link Kattar Bund Road,
Thokar Niaz Baig, Multan Road, Lahore by panel to be
constituted by Chairman Registration Board for further
granting contract manufacturing permission as the firm has
already been granted approval for contract manufacturing of
numerous products.
Evaluation by PEC Firm has submitted the panel inspection report of M/s English
Pharmaceutical Industries, Lahore conducted on 18-01-2019,
in response to letter no. F.3-9/2018 Reg-II (M-286) (Misc.), for
the purpose of assesment and confirmation of manufacturing
capacity for contract manufacturing of Omeprazole dry powder
Injection wherein the panel of inspectors has reported as under:
 As per record the firm has manufactured 16 batches of
different products to a total number of 127,490 vials
during year 2018 with an average production of 1499
vials per day. Hence utilized capacity of the firm was
about 4%.
 Firm has provided necessary equipment for carrying
out the required QC testing of the products.
contract manufacturing by
Brand Name +Dosage Form + Strength Omefin Injection 40mg
Omeprazole as sodium……40mg
Type of Form Form 5
Approval status of product in Reference Omeprazole IV of sandoz (TGA)
Me-too status Loprot of Nabiqasim
1 year.
overage.
numerous products.
Evaluation by PEC As recorded for above application
Brand Name +Dosage Form + Strength Fespan Injection 40mg
Pantoprazole as sodium……40mg
Type of Form Form 5
Approval status of product in Reference Protonix by wyeth (USFDA
Me-too status Neege by Sami
1 year.
overage.
numerous products.
Brand Name +Dosage Form + Strength Naplin Injection 1g
Vancomycin as Hydrochloride ……1 g
Pharmacological Group Glycopeptide antibacterial
Type of Form Form 5
Approval status of product in Reference Vancomycin 1g of Fresenius Kabi, USA (USFDA
Me-too status Vinjec injection by Bosch
1 year.
overage.
numerous products.
Brand Name +Dosage Form + Strength Naplin Injection 500mg
Vancomycin as Hydrochloride ……500 mg
Type of Form Form 5
Approval status of product in Reference Vancomycin 500mg of Fresenius Kabi, USA (USFDA
Me-too status Vinjec injection by Bosch
1 year.
overage.

numerous products.
235. Name and address of manufacturer / M/s City Pharmaceutical Laboratories, Plot No. 12-A,
Applicant Sector 5, I-5, New Serveyno-276, Korangi Industrial
Area, Karachi.
Brand Name +Dosage Form + Strength Spastop tablets 40mg
Composition Each film coated tablet contains:
Drotaverine as hydrochloride………40mg
Pharmacological Group Non-anticholinergic antispasmodic
Type of Form Form-5
Finished product Specification Manufacturer‘s specifications
Pack size & Demanded Price 2x10‘s; Rs.40.00/-
Approval status of product in Reference Approved by 3 EMA member states i.e. Poland,
Regulatory Authorities. Hungary, Latvia
Me-too status No-Spa 40mg tablet of M/s Sanofi Aventis
GMP status Last GMP inspection conducted on 06-03-2018 and the report
concludes that the firm is considered to be operating at
satisfactory level of compliance with GMP guidelines.
Remarks of the Evaluator. Firm has submitted revised formulation for uncoated tablets
Previous decision Registration Board in its 284th meeting deferred for submission
of requisite fee for change of formulation.
Evaluation by PEC Firm has submitted the fee of Rs. 5,000/- vide deposit slip#
0746032 dated 20-02-2019, for change of formulation of
Spastop 40mg tablets.
Decision: Approved with Innovator‘s specifications and change of brand name as ―uncoated tablet‖.
236. Name and address of manufacturer / M/s Cibex (Pvt.) Ltd., F-405, S.I.T.E., Karachi
Applicant
Brand Name +Dosage Form + Strength Cimora 10mg sachet
Composition Each sachet contains:
Esomeprazole (as magnesium) ECP 8.5%..........10mg
Source of granules: Vision Pharmaceuticals
Type of Form Form-5
Pack size & Demanded Price 28‘s; As per PRC
Approval status of product in Reference Nexium (USFDA approved)
Me-too status Axesom of M/s Highnoon
GMP status Certificate of cGMP based on evaluation conducted on 20-09-
17 is provided.
Remarks of the Evaluator. Firm has submitted original fee challan of Rs. 20,000/- (deposit
slip# 0708918) submitted to DRAP on 31-07-2018 for Cimora
(Esomeprazole) 10mg sachet.
Previous decision Registration Board in its 285th meeting referred the case to QA
& LT Division to conduct GMP inspection of Firm on priority.
Evaluation by PEC Firm has submitted copy of GMP certificate issued by Add.
Director, DRAP Karachi issued on the basis of inspection
conducted on 25-9-2018
237. Name and address of manufacturer / M/s Winthrox Laboratories (Pvt) Ltd, Plot No. K-219-A,
Applicant Phase-II, S.I.T.E., Karachi.
Brand Name +Dosage Form + Strength Cefozil dry suspension 250mg/5ml
Composition Each 5ml contains:
Cefprozil (as monohydrate)…250mg
Diary No. Date of R& I & fee Diary No:15205, 24/04/2018, Rs. 20,000/- (23/04/2018)
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price As per DRAP policy
Approval status of product in Reference USFDA Approved as 250mg anhydrous cefprozil
Me-too status Vegapro 250mg/5ml dry powder for Suspension of
M/s Vega Pharmaceuticals as 250mg anhydrous cefprozil
GMP status 14-09-2017 Panel recommends grant of Additional sections
Remarks of the Evaluator. You have applied for formulation containing Cefprozill
monohydrate 250mg/5ml while the reference product approved
in USFDA contains cefprozil equivalent to 250mg anhydrous
cefprozil per 5ml of constituted suspension, clarification is
required in this regard
Previous decision Registration Board in its 282nd meeting deferred for
clarification of formulation submitted by the firm.
Evaluation by PEC Firm has submitted master formulation declaring the content of
Ceprozil monohydrate eq. to 250mg of Cefrprozil anhydrous
per 5 ml.
Decision: Approved.
238. Name and address of manufacturer / M/s Evolution Pharmaceuticals Pvt. Ltd. Plot # 25 & 26, Street
Applicant S-3, RCCI, National Industrial Zone, Rawat, Islamabad..
Brand Name +Dosage Form + Strength Evoprin 300mg Dispersible Tablet
Composition Each dispersible Tablet Contains:
Aspirin…300mg
Pharmacological Group Analgesic
Type of Form Form-5
Finished product Specification
Pack size & Demanded Price 100‘s,200‘s,300‘s & 600‘s; as per SRO
Me-too status --
GMP status Last inspection report dated 25-10-2018 with following
recommendations:
―As the operations have not started as of yet at M/s Evolution
Pharmaceuticals, Rawat the GMP status can only be
ascertained upon the start of active pharmaceutical , however ,
keeping in view the facility inspected the firm has requisite
manufacturing facility for manufacturing of Pharmaceuticals.
Remarks of the Evaluator.  Evidence of applied formulation/drug already approved by
Previous decision Registration Board in its 286th meeting deferred for evidence of
applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and
name of firm.
Evaluation by PEC Following me-too reference against the applied formulation has
been verified:
―Disprin Cold ‗n‘ fever Dispersible tablets of M/s Reckit
Benckiser Pak Ltd. (Reg.# 027536)
Decision: Approved with BP specifications and change of brand name.
239. Name and address of manufacturer / M/s Medizan Laboratories Pvt. Ltd. Plot No.313, Industrial
Applicant Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Bupion SR 75mg tablets
Composition Each sustained release film coated tablet contains:
Bupropion hydrochloride………..75mg
Diary No. Date of R& I & fee Dy.No.1266;(06-10-2016);Rs.20,000/-(03-10-2016)
Type of Form Form-5
Pack size & Demanded Price 20‘s; As decided by the Ministry of Health
Approval status of product in Reference Could not be confirmed in this strength as sustained release
Regulatory Authorities. tablets
Me-too status Wellben SR 75mg tablet of M/s Bosch Pharmaceuticals,
Karachi
GMP status Last GMP inspection conducted on 20-11-2017 and the
report concludes that the firm was considered to be operating
at reasonably acceptable compliance with GMP guidelines as
of today.
Remarks of the Evaluator.  Shortcomings:
regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275 th
meeting.
Previous decision Registration Board in its 283rd meeting deferred for evidence of
approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the
Evaluation by PEC  Firm has requested to change the composition of Bupion
SR 75mg tablets to plain film coated tablets due to
unavailability of sustained formulation in reference
regulatory authorities.
 Firm has submitted revised Form 5 and master formulation
with following composition:
―Each film coated tablet contains:
Bupropion hydrochloride………..75mg
 Firm has also submitted fee of Rs. 5,000/- vide deposit
slip# 0811865 dated 04-02-2019.
Decision: Approved with following composition:
―Each film coated tablet contains:
Bupropion hydrochloride………..75mg‖
240. Name and address of manufacturer / M/s. Farmigea Pakistan (Pvt) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Moxicin 0.5% Eye Drops
Composition Each ml contains:-
Moxifloxacin HCl……..0.5%w/v
Diary No. Date of R& I & fee Dairy No.8991 dated 15.07.2013 Rs:20,000/-
Type of Form Form-5
Pack size & Demanded Price Rs. 195; 5ml
Me-too status Eyemox Eye Drops 0.5%. by M/s Vega Pharmaceuticals,

Lahore (Reg.# 045929)
GMP status Last inspection report conducted on 01-02-2018 wherein panel
has recommended the resumption of production of steroidal
products in the general area as decision of the CLB in its 239th
meeting.
Previous decision Registration Board in its 258th meeting deferred for following:
 Commitment as per 251st meeting of RB is required.
 Shelf life is 3years mentioned by the firm Minutes for
258th Registration Board Meeting whereas 2years are
allowed by the Board.
 Availability is SRA is not provided.
 Latest inspection report is required.
 Reference Literature for full description of the
specification and analytical method for API, Excipients
and Finished product is required.
 Type of plastic container and compatibility stability of the
product with container may also be approved.
 Most of documents are not signed by QC Manger and
Production In charge.
Evaluation by PEC  Firm has submitted that their bottle is with Drop-tainer
dispensing system consisting of a transparent low density
polyethylene bottle and dispensing plug and white
polypropylene closure. Tamper evidence is provided by a
security seal around the closure of the bottle. This
container closure system is same as that of the reference
product.
 Moreover firm has submitted Form 5, rectifying the other
shortcomings.
 Evidence of international availability has been verified
from the MHRA of UK.
Decision:Deferred for confirmation of manufacturing/packaging facility of bottle with Drop-tainer
dispensing system consisting of a transparent low density polyethylene bottle and dispensing plug
and white polypropylene closure.
Applicant
Brand Name +Dosage Form + Strength Ocufusic 1% Eye Drops
Fusidic acid ..… 1%
Diary No. Date of R& I & fee Dairy No.9874 dated 21-08-2013 Rs:20,000/-
Type of Form Form-5
Approval status of product in Reference Fucithalmic 1%w/w viscous eye drops approved by MHRA of
Regulatory Authorities. UK
Me-too status Eyemox Eye Drops 0.5%. by M/s Vega Pharmaceuticals,
Lahore (Reg.# 045929)
products in the general area as decision of the CLB in its 239 th
meeting.
 Shelf life is 3years mentioned by the firm Minutes for

258th Registration Board Meeting whereas 2years are
allowed by the Board.
 Availability is SRA is not provided.
 Latest inspection report is required.
 Reference Literature for full description of the
specification and analytical method for API, Excipients
and Finished product is required.
 Type of plastic container and compatibility stability of the
product with container may also be approved.
 Most of documents are not signed by QC Manger and
Production In charge.
product.
 Moreover firm has submitted Form 5, rectifying the other
shortcomings.
 Evidence of international availability has been verified
from the MHRA of UK.
Applicant
Brand Name +Dosage Form + Strength Ocufusic 1% Eye Drops
Fusidic acid...… 1%
Diary No. Date of R& I & fee Dairy No.9874 dated 21-08-2013 Rs:20,000/-
Type of Form Form-5
Approval status of product in Reference Fucithalmic 1%w/w viscous eye drops approved by MHRA of
Me-too status Fusitek Eye Drops by Innvotek pharma (Reg.# 026957)
products in the general area as decision of the CLB in its 239 th
meeting.
 Confirmation of container closure system whether as per
innovator or otherwise
 Clarification of composition as reference product states
composition as mg/gm whereas composition of applied
product is stated in mg/ml
product.


Reference product is available as tube.

Moreover firm has submitted Form 5, with composition as
per reference product as under:
―Each gm contains:-
Fusidic acid...… 10mg‖
Applicant
Brand Name +Dosage Form + Strength Ocupatol 0.2% Eye Drops
Olopatadine HCl equivalent to Olopatadine ……. 0.2%
Pharmacological Group Anti-allergic
Type of Form Form-5
Me-too status Olopat DS Eye Drops by M/s Vega Pharmaceuticals, Lahore
(Reg.# 069169)
GMP status Last inspection report conducted on 07-12-2016 with remarks
of satisfactory level of GMP compliance.
Remarks of the Evaluator. Firm has submitted that they will be using same container
closure system as that of the reference product.
Evaluation by PEC Firm has submitted that copy of Last inspection report
conducted on 01-02-2018 wherein panel has recommended the
resumption of production of steroidal products in the general
area as decision of the CLB in its 239th meeting.
Applicant
Brand Name +Dosage Form + Strength Levoflox Eye Drop
Levofloxacin as hemihydrate ….…0.5% w/v
Pharmacological Group anti biotic/ floroquinolone
Type of Form Form-5
Finished product Specification JP
Me-too status Xeflox Eye Drops 0.5% by M/s Helix Pharma, Karachi (Reg.#
042189)
Previous decision  Registration Board in its 288th meeting referred the case to
QA & LT Division to conduct GMP inspection of Firm on
priority.

Applicant
Brand Name +Dosage Form + Strength Nepanac 0.1% Gel Eye Drops
Nepafenac…..0.1%
Diary No. Date of R& I & fee Dairy No. 9873 dated 21.08.2013 Rs:20,000/-
Pharmacological Group anti-inflammatory
Type of Form Form-5
Finished product Specification Manufacturer Specifications
Me-too status Venac 0.1% Eye Drops by M/s M/s Vega Pharmaceuticals
(Pvt) Ltd, Lahore (Reg.# 069189)
246. Name and address of manufacturer / M/s Atco Laboratories Limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Prolox powder for oral suspension 500mg/5ml
Composition When reconstituted, each 5ml contains:
Ciprofloxacin (as hydrochloride)........500mg
Source of Ciprofloxacin taste masked granules: M/s Surge
Laboratories Pakistan
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form-5
Finished product Specification Manufacturer‘s specification
Pack size & Demanded Price 15ml; Rs.1200/- 30ml; Rs.2400/-
60ml; Rs.4800/- 90ml; Rs.7200/-
120ml; Rs.9600/-
Me-too status Quash 500mg/5ml suspension of M/s Wilshire Lab. Pvt. Ltd.
GMP status Panel inspection conducted on 21-07-2017 concludes that
firm is operating at the good GMP compliance.
Remarks of the Evaluator.  Firm has submitted revised master formulation with
following composition:
―When reconstituted, each 5ml contains:
Ciprofloxacin........ 500mg ―

Firm has also submitted fee of Rs. 5,000/- for revision of
formulation vide deposit slip#. 0821164.
Previous decision Registration Board in its 287th meeting for further deliberation
upon the salt form of API, in view of reference product.
Evaluation by PEC Firm has referred to USP 41 monograph of ―Ciprofloxacin
suspension‖, wherein Ciprofloxacin RS has been used instead
of Ciprofloxacin HCl RS for identification and other tests.
Hence it could be inferred that Ciprofloxaicn suspension
contains Ciprofloaxaicn in base form.
Decision: Approved with USP specifications as per following composition:
Ciprofloxacin........ 500mg‖
Applicant
Source of Ciprofloxacin taste masked granules: M/s Surge
Laboratories Pakistan
Type of Form Form-5
60ml; Rs.2400/- 90ml; Rs.3600/-
120ml; Rs.4800/-
Me-too status Quash 250mg/5ml suspension of M/s Wilshire Lab. Pvt. Ltd.
 Firm has also submitted fee of Rs. 5,000/- for revision of
Diluent shall be as per innovator‘s product.
Applicant
Source of Ciprofloxacin HCL taste masked granules: M/s
Surge Laboratories Pakistan
Type of Form Form-5
60ml; Rs.1200/- 90ml; Rs.1800/-
120ml; Rs.2400/-
Approval status of product in Reference Approved by Registration Board on the recommended dosage
Regulatory Authorities. basis
Me-too status Quash 125mg/5ml suspension of M/s Wilshire Laboratories
Pvt. Ltd.
 Firm has also submitted fee of Rs. 5,000/- for revision of
Diluent shall be as per innovator‘s product.
249. Name and address of manufacturer / M/s Valor Pharmaceuticals. 124/A Industrial Triangle, Kahuta
Applicant Road Islamabad
Brand Name +Dosage Form + Strength Evilar 400mg Soft Gel Capsule
Composition Each Soft Gel Capsule Contains:
Alpha tocopheryl acetate...…400mg
Pharmacological Group Vitamin
Type of Form Form-5
Finished product Specification Manufacture specs.
Pack size & Demanded Price 100‘s; Rs. 528/-As per SRO
Me-too status Zescap 400mg capsule Of M/s Zafa Pharmaceutical
Laboratories (Pvt) Ltd. (Reg.#030626)
GMP status New section granted on 25-06-2018
regulatory authorities/agencies which were declared/
approved by the Registration Board in its 275th meeting.
Previous decision Registration Board in its 283rd meeting for evidence of
approval of applied formulation in reference regulatory
Registration Board in its 275th meeting as submitted reference
is not verifiable.
Evaluation by PEC Following reference submitted by firm has been verified from
Austrian Agency for Health and Food Safety:
Evit 600 I.E kapseln.
The qualitative comnposition of said product declares
following equivalency:
1 capsule contains:
400 mg = 600 I.U. RRR-alpha-tocopherol
https://aspregister.basg.gv.at/aspregister/faces/aspregister.jspx?
_afrLoop=570329877391478&_afrWindowMode=0&_adf.ctrl-
state=19hs10qzp3_4
Case No. 02 Registration applications of newly granted DML or New section (Human)
a. New DML (Remaining molecule)
CLB in its 267th meeting held on 31st December, 2018 has considered and approved the grant the Drug
Manufacturing License (DML) bby way of formulation to M/ s Dynatis Pakistan (Pvt.) Ltd, Plot No. 710, Sunder
Industrial Estate, Lahore with following six sections and accordingly various applications were considered against
each sectionin previous meetings of Registration Board as detailed under :
Sr.# Name of Section No. of molecules considered Available balance
in previous Board meetings
1. Tablet Section (General) 10 0
2 Capsule Section (General) 9 1
3. Sachet Section (General) 3 7
4. Cream/Ointment Section (General) 8 2
5. Cream/Ointment Section (Steroidal) 10 0
6. Lotion Section (General) 6 4
Now the following products have been applied by firm against the remaining balance of priority molecules, which
are presented hereby for consideration of Registration Board.
Capsule Section (General) 2 products/ 1 molecules
250. Name and address of manufacturer / "Dynatis Pakistan Pvt Ltd. Plot No.710, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore"
Brand Name +Dosage Form + Strength Diltem SR 180mg capsule
Composition Each Capsule Contains:
Diltiazem hydrochloride (as extended release pellets)....180mg
Source of pellets: M/s Alphamed Formulations, India
Pharmacological Group Benzothiazepine derivative
Type of Form Form-5
Pack size & Demanded Price 30‘s: as per DPC
Approval status of product in Approved by MHRA of UK
Reference Regulatory Authorities.
Me-too status Perlita SR Capsule of M/s Wilshire Laboratories (Pvt) Ltd;
(Reg.# 069206)
GMP status Inspection dated 04-12-2018 recommends grant of DML.
Brand Name +Dosage Form + Strength Diltem SR 90mg capsule
Diltiazem hydrochloride (as extended release pellets)….. 90mg
Source of pellets: M/s Alphamed Formulations, India
Pharmacological Group Benzothiazepine derivative
Type of Form Form-5
Pack size & Demanded Price 30‘s: as per DPC
Me-too status Perlita SR Capsule of M/s Wilshire Laboratories (Pvt) Ltd;
(Reg.# 069205)
Lotion Section (General) 1 products/ 1 molecules
Brand Name +Dosage Form + Strength Dynasten 1% Lotion
Composition Each gm Contains:
Clotrimazole ………… 1%
Diary No. Date of R& I & fee Dy. No 5838 dated 11-02-2019 Rs.20,000/- Dated 11-02-2019
Type of Form Form-5
Pack size & Demanded Price as per DPC
Approval status of product in Approved by USFDA
Me-too status Dandizole Lotion of M/s Wilson‘s Pharmaceuticals; (Reg.#
037754)

Cream/Ointment Section (General) 1 products/ 1 molecules
Brand Name +Dosage Form + Strength Dexiclo 4% Gel
Chlorhexidine digluconate 7.1% w/w equivalent to 4% w/w
Chlorhexidine
Pharmacological Group Antiseptic & Anti-infective
Type of Form Form-5
Pack size & Demanded Price as per DPC
Approval status of product in Recommended in WHO Essential medicine llist
Me-too status
Remarks of the Evaluator Stability data required.

Decision: Deferred for confirmation of approval of required manufacturing facility of ―Gel section‖
from CLB. Moreover Board advised for product‘s stability data for the applied formulation.

b. New/Additional Section(s).
Case of M/s Don Valley Pharmaceuticals. 31-km, Main Ferozepur Road, Lahore
The CLB in its 269th meeting held on 26-02-2019 has granted New ―Dry Powder Vial Injection
(Cephalosporin)‖ to the firm. The firm has applied for 01 molecule (6 products) in the said section.
254. Name and address of manufacturer / "M/s Don Valley Pharmaceuticals. 31-km, Main Ferozepur Road,
Applicant Lahore"
Brand Name +Dosage Form + Strength Tridon IV 1gm Injection
Ceftriaxone Sodium Eq. to Ceftriaxone…1gm"
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form 5
Finished Product Specification USP
Me-too status Rezone 1gm Injection IV by M/s Well Care Pharmaceuticals,
Islamabad. (Reg.#031980)
GMP status Grant of Additional section of ―Dry Powder Vial Injection
(Cephalosporin)‖ dated 05-03-2019.
 Decision: Approved.
Applicant Lahore"
Brand Name +Dosage Form + Strength Tridon IV 500mg Injection
Ceftriaxone Sodium Eq. to Ceftriaxone…500mg"
Type of Form Form 5
Me-too status Rezone 500mg Injection IV by M/s Well Care Pharmaceuticals,
Applicant Lahore"
Brand Name +Dosage Form + Strength Tridon IM 1gm Injection
Ceftriaxone Sodium Eq. to Ceftriaxone…1gm"
Type of Form Form 5
Me-too status Amcef Injection of M/s Linear Pharma Rawat (Reg.# 075343)
Applicant Lahore"
Brand Name +Dosage Form + Strength Tridon IV 250mg Injection
Type of Form Form 5
Approval status of product in Rocephin Injection IV FDA Approved.
Me-too status Wincef 250 mg IV Injection of M/s Wel Wink Pharmaceuticals
(Reg.# 078096)
Applicant Lahore"
Brand Name +Dosage Form + Strength Tridon IM 250mg Injection
Ceftriaxone Sodium Eq. to Ceftriaxone……250mg"
Type of Form Form 5
Me-too status El-cef Injection of M/s Linear Pharma Rawat (Reg.# 075341)
Applicant Lahore"
Brand Name +Dosage Form + Strength Tridon IM 500mg Injection
Type of Form Form 5
Me-too status Fotamin IM 500 mg Injection by M/s Vision Pharmaceuticals.
(Reg.#030694)

Case of M/s. Aries Pharmaceuticals, (Pvt.) Ltd., I-W, Industrial Estate, Hayatabad, Peshawar.
The CLB in its 269th meeting held on 26-02-2019 has granted New ―Dry Powder Vial Injection (Cephalosporin)‖ to
the firm. The firm has applied for 08 molecule (26 products) in the said section.
260. Name and address of manufacturer / M/s. Aries Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Aricef Plus IV/IM Injection 1g
Cefoperazone as Sodium…….500mg
Sulbactam as Sodium…....…….500mg
Type of Form Form 5
Approval status of product in Reference Approved by PMDA-Japan
Me-too status 2Sum Injection 1g of M/s Sami Pharmaceuticals, Karachi (Reg.#
047002)
GMP status 26-02-2019 Grant of Additional Section.
Panel recommends grant of Additional Section.
Decision:Approved.

Applicant
Brand Name +Dosage Form + Strength Aricef Plus IV/IM Injection 2g.
Cefoperazone as Sodium…….1000mg
Sulbactam as Sodium…....…….1000mg
Type of Form Form 5
Approval status of product in Reference Approved in Europe (Poland, Slovakia,Czech Republic) by EMA
Me-too status CEBAC 2g of M/s Bosch Pharmaceuticals, Karachi (Reg.# 037631)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Kecef IV/IM Injection 250mg
Cefotaxime as Sodium…….250mg
Diary No. Date of R& I & fee Diary No:4642, 01/02/2019 , Rs: 20,000/-
Type of Form Form 5
Me-too status Cefotax by Bosch
Decision:Approved.

Applicant
Diary No. Date of R& I & fee Diary No: , 01/02/2019 , Rs: 20,000/-
Type of Form Form 5
Me-too status Getex Dry powder Injection 500mg by M/s Amarant from
Medicaid, Karachi (Reg#080278)
Decision:Approved.
Applicant
Diary No. Date of R& I & fee Diary No: 4644 , 01/02/2019 , Rs: 20,000/-
Type of Form Form 5
Me-too status Getex Dry powder Injection 1gm by M/s Amarant
from Medicaid, Karachi (Reg#080279)
Decision:Approved.

Applicant
Brand Name +Dosage Form + Strength Kecef IV/IM Injection 2.0gm
Cefotaxime as Sodium…….2.0gm.
Diary No. Date of R& I & fee Diary No: 4645, 01/02/2019 , Rs: 20,000/-
Type of Form Form 5
Me-too status Claforan Injection 1gm by M/s Sanofi Aventis from Medicaid,
Karachi (Reg#076156)

Decision:Approved.

Applicant
Brand Name +Dosage Form + Strength Arizid IV/IM Injection 250mg.
Ceftazidime pentahydrate eq. to Ceftazidime…….250mg.
Type of Form Form 5
Me-too status Ceplo Injection 250mg IM/IV of M/s Cirin Parma (Pvt.) Ltd,
(Reg.# 024415)
Remarks of the Evaluator.  In contrary to approved by the reference agencies/authorities
wherein the applied formulation is approved as Ceftazidime ―as
pentahydrate‖ equal to 250mg, you have applied for
Ceftazidime ―as Sodium‖ equal to 250mg. Clarification is
required in this regard.
 Upon communication of above observation, now firm has
submitted revised composition as per reference product, which
has been corrected above. Moreover firm has submitted Rs.
5,000 for revision of formulation vide deposit slip# 0829912
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arizid IV/IM Injection 500mg.
Type of Form Form 5
Me-too status Vegazid 500mg Injection of Vega Pharmaceuticals (Reg.# 078704)
Decision:Approved.
th
Minutes of 289 Meeting of Registration Board (14-16 May, 2019) | 124
Applicant
Brand Name +Dosage Form + Strength Arizid IV/IM Injection 1.0gm.
Type of Form Form 5
Me-too status Vegazid 1gm Injection of Vega Pharmaceuticals (Reg.# 078705)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Bactocef IM Injection 250mg.
Ceftriaxone as Sodium…….250mg.
Diary No. Date of R& I & fee Dy.No 5847 dated 11-02-2019 Rs.20,000/- Dated 11-02-2019
Type of Form Form 5
Me-too status El-cef Injection of M/s Linear Pharma Rawat (Reg.# 075341)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Bactocef IM Injection 500mg.
Type of Form Form 5
Me-too status Fotamin IM 500 mg Injection by M/s Vision Pharmaceuticals.
(Reg.#030694)

Decision:Approved.

Applicant
Brand Name +Dosage Form + Strength Bactocef IM Injection 1.0gm
Ceftriaxone as Sodium…….1.0gm
Type of Form Form 5
Me-too status Amcef Injection of M/s Linear Pharma Rawat (Reg.# 075343)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arizon IV Injection 250mg.
Type of Form Form 5
Approval status of product in Reference Rocephin Injection IV FDA Approved.
Me-too status Wincef 250 mg IV Injection of M/s Wel Wink Pharmaceuticals
(Reg.# 078096)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arizon IV Injection 500mg.
Type of Form Form 5

Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arizon IV Injection 1.0gm.
Ceftriaxone as Sodium…….1.0gm.
Type of Form Form 5
Me-too status Rezone 1gm Injection IV by M/s Well Care Pharmaceuticals,
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arizon IV Injection 2.0gm.
Ceftriaxone as Sodium…….2.0gm.
Type of Form Form 5
Approval status of product in Reference Rocephin Injection IV FDA Approved.
Me-too status ANTRIX Injection I.V of M/s Fynk Pharmaceuticals, (Reg.#
077172)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arirox IV/IM Injection 250mg.
Cefuroxime as Sodium…….250mg.
Type of Form Form 5
Me-too status Cefulite powder Injection by M/s Elite Pharma (Reg.#067747)
Decision:Approved.
Applicant

Brand Name +Dosage Form + Strength Arirox IV/IM Injection 750mg.
Cefuroxime as Sodium…….750mg.
Type of Form Form 5
Me-too status Astalexim 750mg Injection by M/s Astellas Pharmaceuticals,
Peshawar (Reg.#079751)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Arirox IV/IM Injection 1.5gm.
Cefuroxime as Sodium…….1.5gm.
Type of Form Form 5
Me-too status Astalexim 1.5g Injection by M/s Astellas Pharmaceuticals,
Peshawar (Reg.#079750)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Cefgen IV Injection 500mg.
Cefpirome Sulfate Eq. to Cefpirome …….500mg.
Type of Form Form 5
Finished product Specification Manufacturer Specification
Approval status of product in Reference Cefrom Injection Approved by ANSM of France
Me-too status Welrome Dry Powder Injection by M/s Welwrd Pharmaceutical
(Reg.# 040372)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Cefgen IV Injection 1000mg.

Cefpirome Sulfate Eq. to Cefpirome …….1000mg.
Type of Form Form 5
Approval status of product in Reference Cefrom Injection Approved by ANSM of France
Me-too status Welrome Dry Powder Injection by M/s Welwrd Pharmaceutical
(Reg.# 040373)
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Cefradin IV/IM Injection 250mg.
Cephradine L-Arginine Eq. to Cephradine …….250mg.
Type of Form Form 5
Me-too status Velosef Injection by GSK-Pakistan
Remarks of the Evaluator. Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board
in its 275th meeting
Applicant
Type of Form Form 5
Approval status of product in Reference Cefril-A Injection Bristol-Myers Squibb
authorities/agencies which were adopted by the Registration Board in its 275 thmeeting
Applicant

Type of Form Form 5
Approval status of product in Reference Cefril-A Injection Bristol-Myers Squibb
Applicant
Brand Name +Dosage Form + Strength Arimep IV/IM Injection 500mg.
Cefepime HCl L-Arginine Eq. to Cefepime…….500mg.
Type of Form Form 5
Approval status of product in Reference MAXIPIME Injection Hospira (USAFDA Approved)
Me-too status Gepin Dry Powder Injection 500mg by M/s Amarant from
Medicaid Karachi. (Reg.#080281)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Arimep IV/IM Injection 1000mg.
Cefepime HCI L-Arginine Eq. to Cefepime…….1000mg.
Type of Form Form 5
Approval status of product in Reference MAXIPIME Injection Hospira (USAFDA Approved)
Me-too status Gepin Dry Powder Injection 1gm by M/s Amarant from Medicaid
Karachi. (Reg.#080282)
Decision:Approved.
Case of M/s TAS. Pharmaceuticals (Pvt.) Ltd, Islamabad.
The CLB in its 267th meeting held on 31.12.2018 has granted New Capsule Section (General) to the firm. The firm

has applied for 04 molecules (6 products) in the New Capsule Section (General).
286. Name and address of manufacturer / TAS. Pharmaceuticals (Pvt.) Ltd, Plot No 209, Kahuta Tiangle,
Applicant Humak Industrial Area, Islamabad.
Brand Name +Dosage Form + Strength BIOESO 20mg Capsule
Composition Each hard gelatin Capsule contains:
Enteric coated pellets of Esomeprazole Magnesium trihydrate
equivalent to Esomeprazole ……. 20mg.
Source of pellets: M/s Vision Pharmaceuticals, Islamabad
Diary No. Date of R& I & fee Diary No 11345, Dated 05/03/2019, Rs 20000/- , Dated
04/03/2019
Type of Form Form 5
Pack size & Demanded Price Unit price & pack size as per DRAP policy.
Me-too status Esopol Capsule 20mg of M/s Hassan Pharmaceuticals (Pvt.)
Ltd., (Reg.# 064143)
GMP status Grant of Additional section of ―Capsule Section (General)‖
dated 17-01-2019.
Remarks of the Evaluator.  Firm has submitted Rs. 5,000/- vide deposit slip# 1934510
dated 07-05-2019 for revision of formulation
Decision:Approved.
287. Name and address of manufacturer / TAS. Pharmaceuticals (Pvt) Ltd, Plot No 209, Kahuta Tiangle,
Brand Name +Dosage Form + Strength BIOESO 40mg Capsule
Enteric coated pellets of Esomeprazole Magnesium trihydrate
equivalent to Esomeprazole ……. 40mg.
04/03/2019
Type of Form Form 5
Me-too status Esopol Capsule 40mg of M/s Hassan Pharmaceuticals (Pvt) Ltd.,
(Reg.# 064144)
dated 17-01-2019.
Decision: Approved.
Brand Name +Dosage Form + Strength BIOZOLE 20mg Capsule
Enteric coated pellets of Omeprazole equivalent to Omeprazole
……. 20mg.
04/03/2019
Type of Form Form 5

Me-too status Ruling 20 mg Capsule of M/s High-Q (Reg.#044191)
dated 17-01-2019.
Brand Name +Dosage Form + Strength BIOZOLE 40mg Capsule
Enteric coated pellets of Omeprazole equivalent to Omeprazole
……. 40mg.
04/03/2019
Type of Form Form 5
Me-too status Acizole Capsule 40mg by M/s Cirin Pharmaceuticals, (Reg#
034369)
dated 17-01-2019.
Brand Name +Dosage Form + Strength TASOCIN 250mg Capsule
Azithromycin Di-hydrate equivalent to Azithromycin … 250mg
Diary No. Date of R& I & fee Diary No 11349, Dated 05/03/2019, Rs 20000/- 04/03/2019
Pharmacological Group Macrolides
Type of Form Form 5
Me-too status Exthro 250mg Capsule by M/s Indus Pharma. (Reg.# 055935)
dated 17-01-2019.
Brand Name +Dosage Form + Strength TASOLINE 0.4mg Capsule
Composition Each hard gelatin Capsule contains :
Tamsulosin HCl sustained release pellets equivalent to
Tamsulosin HCl……. 0.4mg.
04/03/2019

Pharmacological Group Alpha Adrenergic Blockers
Type of Form Form 5
Me-too status Uripro 0.4mg Capsule M/s Getz Pharma (Reg.#081040)
dated 17-01-2019.
Case of "M/s Neutro Pharma (Pvt) Ltd. 9.5 km, Sheikhupura Road,Lahore"
The CLB in its 269th meeting held on 26-02-2019 has granted New ―General Lyophilization section‖ to the firm.
Now the firm has applied for 10 molecules/13 products as presented under:
292. Name and address of manufacturer / "M/s Neutro Pharma (Pvt.) Ltd. 9.5 km, Sheikhupura Road,
Applicant Lahore"
Brand Name +Dosage Form + Strength Neuvir 500mg Injection
Acyclovir …500mg"
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded Price As per pricing policy
Me-too status Aclovir 500mg Powder for Infusion by M/s Genix Karachi
(Reg.#073691)
GMP status Grant of Additional section of ―General Lyophilization section‖
dated 29-01-2019.
Remarks of the Evaluator.  Salt form of Acyclovir is not mentioned in Form 5 and master
formulation.
 Reference product is available in Lyophilized cake form,
whereas submitted master formulation & manufacturing outline
declare that ready to fill powder is being filled in the vials.
Clarification/ justification shall be submitted in this regard.
 Upon communication of above observations vide letter no. F.1-
1/2017/PEC-DRAP (AD PEC-II) dated 25-04-2019, firm has
submitted as under:
 Revised Form 5 with following revised composition:
―Each Vial Contains:
Acyclovir as sodium …500mg‖
 Revised master formulation & manufacturing outline for the
production of applied product by way of Lyophilization
resulting in the formation of Lyophilization cake.
 Firm has also submitted fee of Rs. 5,000/- vide deposit slip#
1918568 dated 08-05-2019.
Decision: Approved as per following composition:
―Each Lyophilized Vial Contains:
Acyclovir ….. 500mg‖
Applicant Lahore"
Brand Name +Dosage Form + Strength Noxi 8mg Injection
Lornoxicam……..8mg"
Type of Form Form 5
Finished Product Specification Manufacturer‘s specifications
Approval status of product in Reference Xefo 8 mg powder and solvent for solution for injection by
Regulatory Authorities. M/s Takeda Austria GmbH, (Austria Approved)
Me-too status Viltaz Injection 8mg/2ml by M/s Wilshire Laboratories
Lahore (Reg. # 077112)
dated 29-01-2019.
Remarks of the Evaluator.  Reference product is available in Lyophilized cake form,
submitted as under:
 Revised Form 5 with revised master formulation &
manufacturing outline for the production of applied product by
way of Lyophilization resulting in the formation of
Lyophilization cake.
1918570 dated 08-05-2019.
Lornoxicam……..8mg"
Applicant Lahore"
Brand Name +Dosage Form + Strength Petra 40mg Injection
Esomeprazole as Sodium…40mg"
Type of Form Form 5
Approval status of product in Reference Nexium IV of M/s Astrazeneca Pharms approved by USFDA
Me-too status Nexum IV 40mg Injection by M/s Getz Pharma, Karachi
(Reg#050651)
dated 29-01-2019.
Remarks of the Evaluator.  Submitted master formulation & manufacturing outline declare
that ready to fill powder is being filled in the vials. Clarification
shall be submitted whether firm has facility of dry powder
filling in their approved ―General Lyophilization section.‖
submitted that we have both facilities of Lyophilized cake form
and ready to fill powder in vial.

Applicant Lahore"
Brand Name +Dosage Form + Strength Lan-30 Injection
Lansoprazole……..30mg"
Type of Form Form 5
Approval status of product in Reference Prevacid IV Injection, Takeda Pharmaceuticals USA,
Regulatory Authorities. (USFDA approved)
Me-too status Belenz Injection 30mg by M/s Wellborne Pharmachem
Hattar. (Reg#054894)
dated 29-01-2019.
Applicant Lahore"
Brand Name +Dosage Form + Strength Azineu 500mg Injection
Azithromycin…….500mg"
Type of Form Form 5
Me-too status Zithromax Injection by M/s Biocare Pharmaceutica, Lahore
(Reg.#053895)
dated 29-01-2019.
Decision:Approved.
Applicant Lahore"
Brand Name +Dosage Form + Strength Omeneu 20mg Injection
Omperazole as sodium…….20mg"
Type of Form Form 5
Finished Product Specification Manufacturer specifications
Me-too status --
dated 29-01-2019.
regulatory authorities/agencies which were declared/approved
by the Registration Board in its 275th meeting could not be
verified.
DRAP (generic / me-too status) alongwith registration number,
brand name and name of firm could not be verified.
were declared/approved by the Registration Board in its 275 th meeting could not be verified.
alongwith registration number, brand name and name of firm could not be verified.
Applicant Lahore"
Brand Name +Dosage Form + Strength Caprenen 1g Injection
Capreomycin as Sulphate…….1gm"
Type of Form Form 5
Me-too status Capacin injection 1gm of M/s Hoffmann Human
Health Pakistan ltd., Lahore (Reg.# 043062)
dated 29-01-2019.
Decision:Approved.
Applicant Lahore"
Brand Name +Dosage Form + Strength V.Zde 200mg/Vial Injection
Voriconazole…….200mg"
Pharmacological Group Anti fungal
Type of Form Form-5
Finished Product Specification Manufacturer specification
Approval status of product in Reference Vfend 200mg powder for solution for injection MHRA
Regulatory Authorities. Approved
Me-too status Vivid Injection 200mg by M/s S.J & G Karachi (Reg#070582)
dated 29-01-2019.
Applicant Lahore"
Brand Name +Dosage Form + Strength Neupanto 40mg Injection
Pantoprazole as Sodium……40mg"
Type of Form Form-5
Finished Product Specification Manufacturer specification
Approval status of product in Reference Pantoprazole 40mg Powder for Solution for Injection or
Regulatory Authorities. Infusion. By M/s TEVA UK Limited (MHRA
Approved)
Me-too status Pazole Dry Powder Injection IV 40mg by M/s Fynk
Pharmaceuticals (Reg#081267)
dated 29-01-2019.
Applicant Lahore"
Brand Name +Dosage Form + Strength Neuvir 250mg Injection
Acyclovir ….… 250mg"
Type of Form Form 5

Me-too status Aclovir 250mg Powder for Infusion by M/s Genix Karachi
(Reg.#073690)
dated 29-01-2019.
Remarks of the Evaluator.  Salt form of Acyclovir is not mentioned in Form 5 and master
formulation.
 Reference product is available in Lyophilized cake form,
submitted as under:
 Revised Form 5 with following revised composition:
―Each Vial Contains:
Acyclovir as sodium …250mg‖
 Revised master formulation & manufacturing outline for the
production of applied product by way of Lyophilization
resulting in the formation of Lyophilization cake.
1918569 dated 08-05-2019.
Acyclovir ….. 250mg‖
Applicant Lahore"
Brand Name +Dosage Form + Strength Claromy 500mg Injection
Clarithromycin as Lactobionate…500mg"
Pharmacological Group Macrolide Antibiotic
Type of Form Form 5
Finished Product Specification BP
Me-too status Maclacin 500mg Injection by M/s Bosch, Karachi
(Reg#061080)
dated 29-01-2019.
Remarks of the Evaluator.  Reference product approved by MHRA is available in
Lyophilized cake form, whereas submitted master formulation
& manufacturing outline declare that ready to fill powder is
being filled in the vials. Clarification/ justification shall be
submitted in this regard.
submitted as under:
 Revised Form 5 with revised master formulation &
manufacturing outline for the production of applied product by
way of Lyophilization resulting in the formation of
Lyophilization cake.
1918571 dated 08-05-2019.
Decision:Approved.
Applicant Lahore"
Brand Name +Dosage Form + Strength Petra 20mg Injection
Esomeprazole as Sodium……20mg"
Type of Form Form 5
Approval status of product in Reference Nexium IV of M/s Astrazeneca Pharms approved by USFDA
Me-too status Pep-Ease 20mg Injection by M/s Safe Karachi (Reg#070827)
dated 29-01-2019.
Applicant Lahore"
Brand Name +Dosage Form + Strength Omeneu 40mg Injection
Omperazole as sodium…….40mg"
Type of Form Form 5
Me-too status RISEK 40MG injection by M/s Julphar Pakistan (Pvt) Ltd
(Reg#045617)
dated 29-01-2019.

Case No. 03 Registration applications for Local Manufacturing of (Veterinary) Drugs.
a. New Cases
305. Name and address of manufacturer / "M/s S.J & G Fazul Ellahie Pvt Ltd. E-46, S.I.T.E. Karachi-75700"
Applicant
Brand Name +Dosage Form + Strength Lox 50mg Injection
Flunixin Meglumine Eq. to Flunixin…50mg"
Diary No. Date of R & I & fee Dy. No 12280 dated 04-04-2018 Rs.20,000/- Dated 04-04-2018
Type of Form Form-5
Pack size & Demanded Price 50ML, 100ML
Me-too status (with strength and dosage Fluean injection by M/s Leads Pharma (Pvt.) LTD., Islamabad
form) (Reg.#034589)
GMP status Last inspection report dated 02/05/18 concluding as under:
―The firm has complied/improved according to the directions of the
FID. Panel was satisfied for the improvements under taken by the
firm to comply with the observations dated 12th July 2017. Further
the panel advised the firm to continue the improvements process
Decision:Approved.
306. Name and address of manufacturer / "M/s Mylab Pvt Ltd. Khankah Sharif Bahawalpur"
Applicant
Brand Name +Dosage Form + Strength Monasin 20% Premix
Composition "Each Kg Contains:
Monensin Sodium…….200gm"
Type of Form Form-5
Pack size & Demanded Price 1Kg, 5Kg, 10Kg, 20Kg, 25Kg
Me-too status (with strength and dosage MONENSIN 20% PREMIX by M/s VETMED (REGD) LAHORE
form) (Reg.#025305)
GMP status Last inspection report dated 13 & 14-09-2018 recommending
renewal of DML.
Decision:Approved.
Applicant
Brand Name +Dosage Form + Strength Toxisorb Powder
Silicon Dioxide……69.1%
Aluminium Trioxide…….18.9%
Feric Oxide……5.75%
Magnesium Oxide…….2.92%
Sodium Oxide……..0.53%"
Pharmacological Group Mineral mixture
Type of Form Form-5
Pack size & Demanded Price 1Kg, 2.5Kg,5Kg, 10Kg, 20Kg, 25Kg
Me-too status (with strength and dosage MYCO-AD POWDER by M/s TAROBINA CORP LAHORE
form) (Reg.#020841)
renewal of DML.

Applicant
Brand Name +Dosage Form + Strength Tylofen Injection
Tylosin Tartrate……. 15gm
Gentamycin Sulphate…….6gm
Dexamethasone as Sodium Phosphate…..… 0.0265gm
Chlorophenramine (Maleate)……. 0.750gm"
Pharmacological Group Antibiotic, anti-inflammatory and antihistamine
Type of Form Form-5
Pack size & Demanded Price Clear glass vials of 10ml, 20ml, 30ml, 50ml,100ml.
Me-too status (with strength and dosage Genta Combisone Injection by M/s Leads Pharma (Pvt) Ltd.,
form) Islamabad (Reg.#046696)
renewal of DML.
II
Decision: RegistrationBoard referred the case to ―Expert Veterinary Group for Veterinary Drugs‖ for
review of formulation.
Applicant
Brand Name +Dosage Form + Strength Piperax Water Soluble Powder
Composition "Each kg Contains:
Piperazine Citrate…500gm"
Pharmacological Group Anthalmentic
Type of Form Form-5
Pack size & Demanded Price 1Kg, 5Kg, 10Kg, 20Kg, 25Kg
Me-too status (with strength and dosage Pipera-G Water Soluble Powder by M/s GALLIPHARM
form) International Rawalpindi. (Reg.#020105)
renewal of DML.
II
Applicant
Brand Name +Dosage Form + Strength Novazyme Powder
Composition "Each 100gm Contains:
Cellulase…… 4200,000 IU
Xylanase….. 2500,000 IU
Phytase…200,000 IU
Alpha Amylase….…700,000 IU
Pectinase……. 50,000 IU"
Pharmacological Group Enzymes
Type of Form Form-5
Pack size & Demanded Price 1Kg,2.5Kg, 5Kg, 10Kg, 20Kg, 25Kg
Me-too status (with strength and dosage NATUZYME POWDER by M/s GHAZI BROTHERS,
form) KARACHI (Reg.#034512)
renewal of DML.
Remarks of the EvaluatorII  Evidence of applied formulation/drug already approved by
brand name and name of firm since submitted reference is of
different composition.
 Upon communication of above observation firm has submitted
revised Form 5 with following composition as per me-too
reference :
―Each 1000gm Contains:
Cellulase…… 4200,000 IU
Xylanase….. 2500,000 IU
Phytase…200,000 IU
Alpha Amylase….…700,000 IU
Pectinase……. 50,000 IU
Calcium carbonate ….. 500gm‖

Firm has also submitted fee of Rs. 5,000/- vide dated 08-05-
2019 for revision of formulation.
Decision: Registration Board did not accede with firm‘s request for revision of formulation with
inclusion of an additional API and deferred for evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith registration number, brand name and name of firm.
Applicant
Brand Name +Dosage Form + Strength Hi-Pyrine Injection
Antipyrine….…400mg"
Pharmacological Group Analgesic & Antipyretic
Type of Form Form-5
Pack size & Demanded Price Clear glass vials of 10ml, 20ml, 30ml, 50ml,100ml.
Me-too status (with strength and dosage ANTIPIRINA-40 INJECTION by M/s SELJUK INC
form) ISLAMABAD (Reg.#020093)
renewal of DML.
II
Decision: RegistrationBoard referred the case to ―Expert Veterinary Group for Veterinary Drugs‖ for
review of formulation.
Applicant
Brand Name +Dosage Form + Strength Mylan 250 Premix
Tylosin Tartrate……250gm"
Type of Form Form-5
Pack size & Demanded Price 1Kg,5Kg, 10Kg, 20Kg, 25Kg
Me-too status (with strength and dosage TYLAN PREMIX 250 by M/s ELI LILLY PAKISTAN,
form) (Reg.#013730)
renewal of DML.
II
brand name and name of firm since submitted reference is of
different composition.
 Upon communication of above observation firm has submitted
revised Form 5 with following composition as per me-too
reference :
―Each Kg Contains:
Tylosin phosphate …… 250gm‖
 Firm has also submitted fee of Rs. 5,000/- vide dated 08-05-
2019 for revision of formulation.
Decision: Approved with change of brand ame as per following composition:
―Each Kg Contains:
Tylosin phosphate …… 250gm‖
Applicant
Brand Name +Dosage Form + Strength Toxifix Plus Powder
Calcium Propionate…8.9%
Fumaric Acid & lactic acid……2.4%
Butylated Hydroxianisole…….0.2%"
Pharmacological Group Calcium supplement and acidifier
Type of Form Form-5
Me-too status (with strength and dosage TOXI BIND DRY POWDER by M/s VET PHARMA
form) GUJRANWALA (Reg.#020823)
renewal of DML.
II
Applicant
Brand Name +Dosage Form + Strength Betamax Powder
Composition "Each gm Contains:
Betaine Anhydrous…97%"
Pharmacological Group Dietary supplement
Type of Form Form-5
Me-too status (with strength and dosage BETAFIN SCR POWDER by M/s U.M.ENTERPRISES
form) KARACHI. (Reg.#018420)
renewal of DML.
II
Applicant
Brand Name +Dosage Form + Strength Enrex 80 Premix
Composition "Each kg Contains:
Enramycin……80gm"
Type of Form Form-5
Me-too status (with strength and dosage ENRAMYCIN F.80 by M/s HOECHST PHARMACEUTICAL
form) KARACHI (Reg.#015483)
renewal of DML.
II
316. Name and address of manufacturer / "M/s Selmore Pharmaceuticals Pvt Ltd. 36-Km, Multan Road
Applicant Lahore."
Brand Name +Dosage Form + Strength Eva 100ml Injection
L-arginine HCL...1.44mg
L-cysteine HCL...3.20mg
L-glutamine...3.20mg
Glycine...3.20mg
L-histidine...1.32mg
L-isoleucine HCL...3.60mg
L-leucine HCL...4.28mg
L-lysine HCL...5.44mg
L-methionine...3.20mg
L-threonine...3.20mg
L-tryptophan...0.86mg
L-phenylalanine...5mg
L-valine...3.60mg
Thiamine HCL...4mg
Riboflavin Sod. Phosphate...0.171mg
Pyridoxine HCL...0.34mg
Nicotinamide...8mg
Ascorbic Acid...4mg
Glucose...33mg
Calcium Chloride...0.08mg
Potassium Chloride...0.21mg
Magnesium Sulphate...0.08mg"
Pharmacological Group Vitamins, amino acids & mineral supplement.
Type of Form Form-5
Pack size & Demanded Price 100ml glass container
Me-too status Ami-Vicom Injection by M/s Selmore Lahore (Reg.#016294)
GMP status Last inspection report dated 05-03-2018, 17-08-2018 & 16-10-2018
recommending renewal of DML.
Applicant Lahore."
Brand Name +Dosage Form + Strength Amoxiclox 50/100 mg Injection
Cloxacillin as Sodium…50mg
Amoxicillin as Trihydrate…….100mg"
Pharmacological Group Penicillin
Type of Form Form-5
Pack size & Demanded Price 100ml glass vial
Me-too status (with strength and dosage Clomix injection by M/s Alina Combine Pharmaceuticals (Pvt)
form) Ltd., Karachi. (Reg.#049680)

Applicant Lahore."
Brand Name +Dosage Form + Strength Amoxiclox 50/100 mg Injection
Cloxacillin as Sodium…50mg
Amoxicillin as Trihydrate…….100mg"
Type of Form Form-5
Me-too status (with strength and dosage Clomix injection by M/s Alina Combine Pharmaceuticals (Pvt)
form) Ltd., Karachi. (Reg.#049680)
II
Decision: Approved with innovator‘s specification.
Applicant Lahore."
Brand Name +Dosage Form + Strength Cloxam 100ml Injection
Ampicillin as Trihydrate…125mg
Cloxacillin as Sodium…125mg"
Type of Form Form-5
Me-too status (with strength and dosage Ampicox injection by M/s Alina Nawan Laboratories
form) (Reg.#035061)
II
Applicant Lahore."
Brand Name +Dosage Form + Strength Eva 250ml Injection
L-arginine HCL...1.44mg
L-cysteine HCL...3.20mg
L-glutamine...3.20mg
Glycine...3.20mg
L-histidine...1.32mg
L-isoleucine HCL...3.60mg
L-leucine HCL...4.28mg
L-lysine HCL...5.44mg
L-methionine...3.20mg
L-threonine...3.20mg
L-tryptophan...0.86mg
L-phenylalanine...5mg
L-valine...3.60mg
Thiamine HCL...4mg
Riboflavin Sod. Phosphate...0.171mg
Pyridoxine HCL...0.34mg
Nicotinamide...8mg
Ascorbic Acid...4mg

Glucose...33mg
Calcium Chloride...0.08mg
Potassium Chloride...0.21mg
Magnesium Sulphate...0.08mg"
Pharmacological Group Vitamins, amino acids & mineral supplement.
Type of Form Form-5
Me-too status (with strength and dosage AMI-VICOM INJECTION by M/s SELMORE AGENCIES
form) LAHORE (Reg.#016294)
Remarks of the EvaluatorII Evidence of Me-too status in applied fill volume is required.
Decision: Deferred for evidence of me-too status in applied fill volume.
321. Name and address of manufacturer / "M/s Prix Pharmaceutica Pvt Ltd.Plot No 5, Pharmacity, 30-km
Applicant Multan Road, Lahore"
Brand Name +Dosage Form + Strength Pri-en 20 Injection
Composition "Each ml Injection Contains:
Enrofloxacin…200mg"
Pharmacological Group Fluoroquinolone
Type of Form Form-5
Me-too status (with strength and dosage AN-CIN INJECTION by M/s Elko organization (Reg.#031596)
form)
II
322. Name and address of manufacturer / M/s Noble Pharma, Azad Kashmir
Applicant
Brand Name +Dosage Form + Strength Nobienrox 24% Liquid
Composition Each 100ml contains:-
Enrofloxacin………..…10gm
Aminophyllin…………...4gm
Guaifenesin…………...10gm
Type of Form Form-5
Finished product Specification Inhouse
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml
Me-too status Anrox solution by bio labs Reg # 033240
GMP status Copy of GMP inspection report dated 16-11-2018 concluding as
under:
―GMP is a continual improvement process and keeping in view the
above stated observations during inspection, areas visited,
documents reviewed it is concluded that M/s Noble Pharmaceuticals
AJK has basic facilities for manufacturing and testing of
pharmaceuticals(Vet). At the time of inspection the firm was
operating at an average level of GMP; the areas of improvement
have been discussed and agreed by the representatives if the firm.‖
Remarks of the Evaluator. Firm has Veterinary Oral liquid (General) section.

Applicant
Brand Name +Dosage Form + Strength Flodox-C Oral Liquid
Florfenicol …………..11gm
Colistin Sulphate…….50MIU
Type of Form Form-5
Pack size & Demanded Price 100ml, 500ml, 1000ml
Me-too status Flo raft oral liquid by nawal pharma Reg # 078252
GMP status Copy of GMP inspection report dated 16-11-2018 concluding as
under:
Remarks of the Evaluator. Firm has Veterinary Oral liquid(General) section.
Applicant
Brand Name +Dosage Form + Strength Uniflor-C oral solution/Liquid
Florfenicol …………..230gm
Colistin Sulphate…….50MIU
Pharmacological Group Anti-bacterial
Type of Form Form-5
Pack size & Demanded Price 100ml, 500ml, 1000ml
Me-too status C-flor by Bio-oxine Reg # 074782
Remarks of the Evaluator. Firm has veterinary oral powder(General), veterinary Oral
liquid(General), Veterinary Liquid Vials Injection(General)
Applicant
Brand Name +Dosage Form + Strength Nobien 20% Injection IM
Composition Each ml solution contains:-
Enrofloxacin…………20%
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml
Me-too status Enroquin Forte Injection by Mehran int Karachi Reg # 019045
Remarks of the Evaluator. Firm has Veterinary Liquid Vials Injection(General)
Decision:Approved with innovator‘s specification. Moreover Registration Board directed the firm to
select one fillvolume only for applied formulation.

Applicant
Brand Name +Dosage Form + Strength Nobien 10% Injection
Composition Each ml solution contains:-
Enrofloxacin…………10%
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml
Me-too status SYVAQUINOL-100 INJECTION by SEIGNOR PHARMA
KARACH Reg # 019084
Remarks of the Evaluator. Firm has Veterinary Liquid Vials Injection(General)
Decision:Approved with innovator‘s specification. Moreover Registration Board directed the firm to
select one fill volume only for applied formulation.
b. Deferred Cases
327. Name and address of manufacturer / M/s Ras Pharmaceuticals, Lahore Road, Multan.
Applicant
Brand Name +Dosage Form + Strength WARM-NIL Plus Oral Liquid
Levamisole HCl ……... 1.5gm
Oxyclozanide …… 3.0gm
Cobalt sulphate ……. 0.382gm
Diary No. Date of R& I & fee Dy. No 5125 dated 12-08-2015 Rs.20,000/-
Pharmacological Group Antibacterial/ Dewormer
Type of Form Form-5
Pack size & Demanded Price Decontrolled/ 100ml, 500ml, 1L, 2.5 L , 5 L & 25 L
Me-too status --
GMP status GMP inspection dated 16-10-2018 concluding fair level of GMP
compliance.
Previous Decision: Registration Board in its 253rd meeting deferred for confirmation of
me-too status.
Evaluation by PEC:  Following me-too reference submitted by firm has been verified
against the applied formulation:
―Vital Cure Oral Drench of M/s Prix Pharmaceutical (Pvt.) Ltd.,
Lahore. (Reg.# 063690)
Applicant
Brand Name +Dosage Form + Strength TETZOLE Oral Liquid
Toltrazuril….2.5gm
Vitamin K3…..0.3gm
Diary No. Date of R& I & fee Dy. No 5128 dated 12-08-2015 Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price Decontrolled/ 100ml, 500ml, 1L, 2.5 L , 5 L & 25 L
Me-too status Coccitol Liquid of M/s Grand Pharma (Pvt) Ltd., RCCI Rawat
(Reg.# 062029)
GMP status GMP inspection dated 16-10-2018 concluding fair level of GMP
compliance.
Previous Decision: Registration Board in its 253rd meeting deferred for clarification of
Pharmacological group submitted.
Evaluation by PEC: Firm has submitted that previously pharmacological group was
submitted erroneously and requested to consider the
pharmacological group as ―Anti-protozoal agent against
Coccidiosis‖ as correct pharmacological group for applied
formulation.
Decision: Approved with Innovator‘s Specification.
329. Name and address of manufacturer / M/s Noble Pharma Plot No. B-1, Old Industrial Area, Mirpur AJK,
Applicant Pakistan.
Brand Name +Dosage Form + Strength Nobifenda oral suspension
Oxfendazole…….2.265%w/v
Oxyclozanide…….6.25%w/v
Cobalt sulphate…….0.167%w/v
Sodium selinate……..0.05%w/v
Pharmacological Group Anthelmintic / De wormer
Type of Form Form 5
Finished product Specification Firm has claimed in house specification
Pack size & Demanded Price 100ml, 250ml, 500ml, 1L Pack : Decontrolled
Me-too status Crefenda Oral Suspension by Delux Chemicals Indusrties
(Reg.#058746)
GMP status Last inspection report dated 08-11-2016: Firm is GMP compliant
Previous Decision: Registration Board in its 286th meeting referred the case to QA &
LT Division for updated GMP status of the firm.
Evaluation by PEC: Copy of GMP inspection report dated 16-11-2018 concluding as
under:
Applicant Pakistan.
Brand Name +Dosage Form + Strength Nobimint 10% Powder
Composition Each 100g contains:
Amantadine HCl……10gm
Type of Form Form 5
Pack size & Demanded Price 100g, 250g, 500g, 1Kg Jar : Decontrolled
Me-too status Amantabak 10% powder by Attabak Pharma
under:
Applicant Pakistan.
Brand Name +Dosage Form + Strength Fighter suspension
Albendazole……10g
Ivermectin………0.2g
Triclabendazole…….12g
Pharmacological Group Anthelmintic / De wormer
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1L Pack : Decontrolled
Me-too status Thunder Drench by Star labs
under:
Decision: Approved with innovator‘s specifications and change of brand name.
332. Name and address of manufacturer / M/s Aptly Pharmaceuticals.
Applicant 5-km, Sargodha-Sidhar Bypass Road, Faisalabad
Brand Name +Dosage Form + Strength Apla Flush Oral Powder
Composition "Each 100gm Contains:
Hexamehtylenetetramine…96.5gm
Riboflavin…….1gm
Calcium Pantothenate…0.5gm
Nicotinamide…2.5gm"
Pharmacological Group Antibacterial/Vitamins
Type of Form Form-5
Pack size & Demanded Price 500gm, 1Kg, 2.5 Kg, 5Kg in plastic jars; Decontrolled
Me-too status Arenal Powder of M/s Leads Pharma, Islamabad (Reg.#035197)
GMP status New DML granted on 29-08-2018
Previous Decision of 285th Meeting: Deferred for clarification/justification of quantities of active
pharmaceutical ingredients (APIs) in grams per 100gm.
Evaluation by PEC:  Firm has submitted that composition of their applied product
―Apla Flush‖ was written incorrect. We are therefore humbly
requesting to kindly change the composition of the product as
follows:
Hexamehtylenetetramine…95.5gm
Riboflavin…….1gm
Calcium Pantothenate…0.5gm
Nicotinamide…2.5gm‖
 Firm has submitted Fee of Rs. 5,000/- vide deposit
slip#0794615 dated 12-03-2019 for revision of formulation.
 Following me-too reference against the revised composition has
been verified:
Z-Renal Water Soluble Powder of M/s Zoic International,
Decision: Approved with innovator‘s specifications as per following composition:
Hexamehtylenetetramine…...95.5gm
Riboflavin…….........................1gm
Calcium Pantothenate…........0.5gm
Nicotinamide….......................2.5gm‖
Applicant
Brand Name +Dosage Form + Strength Coliran 25% Oral Solution
Colistin Sulphate……25gm
Diary No. Date of R& I & fee Dy. No. 54; 25-5-2016; Rs.20,000/- (25-5-2016)
Type of Form Form-5
Finished product Specification Mfg
Pack size & Demanded Price 50ml, 100ml, 200ml, 500ml, 1 Liter, 5 Liter, 25Liter Decontrolled
Me-too status Colisulph Liquid by Lexicon Karachi (Could not be confirmed)
GMP status 16-10-2018 Firm was operating at the fair level of GMP
Compliance.
Remarks of the Evaluator. Fee challan Photocopy attached.
Me-too status could not be confirmed.
Previous Decision: Registration Board in its 288th meeting deferred for evidence of
applied formulation/drug already approved by DRAP (generic / me-
too status) alongwith registration number, brand name and name of
firm. Only the pack sizes, already approved by Registration Board
for generic / me-too product will be given.
Evaluation by PEC:  Firm has submitted that the formulation was written mistakenly
and now they have submitted revised Form 5 with following
composition:
―Each 100ml contains:
Colistin Sulphate……480 MIU‖.
 Firm has submitted Rs. 5,000/- for revision of formulation vide
deposit slip# 0714713 dated 02-05-2019
 Following me too reference has been verified against the revised
formulation.
―Colostine Oral Liquid of M/s D-Maarson Pharmaceuticals,
(Reg.#078360)‖
Decision: Approved with innovator‘s specifications as per following composition:
―Each 100ml contains:
Colistin Sulphate……480 MIU‖
Applicant
Brand Name +Dosage Form + Strength DIGESTON-P ORAL POWDER
Composition Each 1000gm contains:-
Propoinic acid calcium……………250g
Propoinic acid sodium……………..400g
Acetanilide…………………………150g
Magnesium Oxide…………………125g
Iron Sulphate………………….…400mg
Zinc Sulphate……………………100mg
Magnesium Sulphate…………….200mg
Copper Sulphate…………………450mg
Cobalt Sulphate……………….…400mg
Sodium Molybdate………….…...100mg
Sodium Chloride…………………...20g
Diary No. Date of R& I & fee Dy. No. 1375, 13-01-2017, 20,000/-, 13-01-2017
Pharmacological Group Minerals
Type of Form Form-5
Finished product Specification In-house
Pack size & Demanded Price 10g, 15g, 25g, 50g, 100g, 250g, 500g, 1Kg, 2.5Kg, 5Kg,
10Kg, 25Kg; Decontrolled
Me-too status Alvegest powder of Star Laboratories
Compliance.
Remarks of the Evaluator. Me-too status could not be confirmed.
firm.
Evaluation by PEC:  Following me too reference has been verified against the revised
formulation.
―BIOGEST ORAL POWDER of M/s BIO-OXIME
PHARMACEUTICALS, (Reg.#0074791)‖
335. Name and address of manufacturer / M/s. Ras Pharmaceuticals (Pvt) Ltd., 25-Km Lahore Road, Multan
Applicant
Brand Name +Dosage Form + Strength SUPER COLI POWDER
Composition Diary No. Nil (Duplicate), 20,000/-, (Photocopy attached) 25-05-
2016
Diary No. Date of R& I & fee Each 100gm contains:-
Colistin Sulphate…………...25.00gm
Type of Form Form-5
Finished product Specification The firm has claimed manufacturer‘s specifications.
Pack size & Demanded Price 100g, 500g, 1Kg, 2.5Kg, 5Kg, 25Kg; Decontrolled
Me-too status N/A
Compliance.
Remarks of the Evaluator.  The submitted me-too reference is of different strength.
firm.
composition:
―Each 100gm contains:-
Colistin Sulphate…………...24.00gm‖
formulation.
―Colimicin Powder of M/s Leads Pharma (Pvt.) ltd., Islamabad
(Reg.#044971)‖
Decision: Approved with innovator‘s specifications and change of brand name as per following
composition:
Colistin Sulphate…………...24.00gm‖
Applicant
Brand Name +Dosage Form + Strength TCD-35 Oral Powder
Composition Each 100gm contains:
Tylosin tartrate……10gm
Doxycycline HCl….20gm
Colistine Sulphate….45 MIU
Bromhexine HCl….4gm
Type of Form Form-5
Finished product Specification In-House
Pack size & Demanded Price 100gm, 500gm, 1kg, 2.5kg, 5kg, 25kg, Decontrolled
Me-too status CD Ras Powder by Zakfas Pharmaceuticals
(Could not be confirmed)
Compliance.
Remarks of the Evaluator. Fee challan Photocopy attached.
Me-too status could not be confirmed.
firm.
composition:
―Each 100gm contains:
Bromhexine HCl…. 0.4gm‖
 Firm ha ssubmitted Rs. 5,000/- for revision of formulation vide
deposit slip# 0714712.
formulation.
―DOXYLINE WATER SOLUBLE POWDER of M/s NSHAL
PHARMACEUTICAL INDUSTRIES (Reg.#075776)‖
Decision: Decision: Approved with innovator‘s specifications as per following composition:
Bromhexine HCl…. 0.4gm‖
Applicant
Brand Name +Dosage Form + Strength AMPRO C-50 Oral Powder
Composition Each gram contains: -
Amprolium HCl …………… 500mg
Diary No. Date of R& I & fee Diary No:19403, 30-10-2017 , Rs: 20,000/-
Type of Form Form-5
Pack size & Demanded Price As per policy of DRAP.
Me-too status BIO-AMP 50% POWDER (Reg.# 023410)
Compliance.
Previous Decision: Registration Board in its 288th meeting deferred for submission of
correct pharmacological group.
Evaluation by PEC:  Firm has submitted correct pharmacological group as
―Antiprotozoal agent against Coccidiosis‖
Decision: Approved.
338. Name and address of manufacturer / M/s International Pharma Labs. Raiwind Road, Bhobtian Chowk,
Applicant defence Road, 1-KM Towards Kahna, Lahore
Brand Name +Dosage Form + Strength SPIROX-10 Oral Powder
Composition Diary No:5138, 12-08-2015 , Rs: 20,000/-
Diary No. Date of R& I & fee Each 100gm contains:
Spiramycin..….10gm
Doxycycline HCl……10gm
Bromhexine HCl….2gm
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price Decontrolled/
100gm, 500gm, 1kg, 2.5kg, 5kg, & 25 kg
Me-too status --
Compliance.
Previous Decision: Registration Board in its 287th meeting deferred for confirmation of
me-too status.
Evaluation by PEC: Following me-too reference submitted by firm has been verified:
AS-PLUS WATER SOLUBLE POWDER of M/s ATTABAK
PHARMACEUTICAL
ISLAMABAD. (Reg.# 071063)
Case No. 04 Registration Applications of Categories to be Considered on Priority.

a. Local manufacturing applications of priority categories defined by
339. Name and address of manufacturer / "M/s Navegal Laboratories. 41/1-A2, Phase-1, Industrial Estate,
Applicant Hattar"
Brand Name +Dosage Form + Strength Tofanib 5mg Tablets
Tofacitinib as Citrate …… 5mg"
Pharmacological Group Immunosuppresants
Type of Form Form-5
Reference Regulatory Authorities
Me-too status (with strength and NA
th
dosage form)
GMP status Last inspection report 11-3-2017 The GMP was satisfactory
brand name and name of firm.
 Evidence o f approval of required manufacturing facility for ―Cytotoxic drugs‖ from CLB.
Applicant Hattar"
Brand Name +Dosage Form + Strength Tofanib 10mg Tablets
Tofacitinib as Citrate …… 10mg"
Pharmacological Group Immunosuppressants
Type of Form Form-5
Me-too status (with strength and NA
dosage form)
II
 Evidence o f approval of required manufacturing facility for ―Cytotoxic drugs‖ from CLB.
Applicant Hattar"
Brand Name +Dosage Form + Strength Famylex 500mg Tablets
Famciclovir…500mg"
Pharmacological Group Antivirals for systemic use
Type of Form Form-5
Me-too status (with strength and Miclovir Tablets 500mg of M/s Cirin Pharmaceuticals, (Reg.#
dosage form) 070361)
Decision:Approved with innovator‘s specifications.
Applicant Hattar"
Brand Name +Dosage Form + Strength Famylex 250mg Tablets
Famciclovir…250mg"
Pharmacological Group Antivirals for systemic use

Type of Form Form-5
Me-too status (with strength and Miclovir Tablets 250mg of M/s Cirin Pharmaceuticals, (Reg.#
II
Applicant Hattar"
Brand Name +Dosage Form + Strength Fingo 0.5mg Capsule
Fingolimod HCl 0.55mg Eq. to Fingolimod …0.5mg"
Type of Form Form-5
Me-too status --
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-
too status) alongwith registration number, brand name and name of firm.
Applicant Hattar"
Brand Name +Dosage Form + Strength Naxia 500mg Capsule
Hydroxyurea……500mg"
Type of Form Form-5
Finished product Specifications Other antineoplastic agents
Pack size & Demanded Price USP
Me-too status (with strength and Hydrine Capsules 500mg by M/s Al-Habib (Reg#022625)
dosage form)
Remarks of the EvaluatorII  Evidence of approval of required manufacturing facility of
―Capsule (Oncology) section‖ from Central Licensing Board.
Decision: Deferred for Evidence of approval of required manufacturing facility of ―Capsule (Oncology)
section‖ from Central Licensing Board.
345. Name and address of manufacturer / "M/s Medpharm Research Lab. 28 km, Ferozepur Road, Lahore"
Applicant
Brand Name +Dosage Form + Strength Medomide 100mg Capsule
Thalidomide…….100mg"
Pharmacological Group Other Immunosuppresants

Type of Form Form-5
Me-too status (with strength and Thalido-100 Capsules by M/s Atco Labs, Karachi (Reg#047188)
dosage form)
GMP status Last inspection dated 12-01-2018 for grant of new DML,
Decision: Approved.
346. Name and address of manufacturer / "M/s Medpharm Research Lab. 28 km, Ferozepur Road, Lahore"
Applicant
Brand Name +Dosage Form + Strength Medoxifen 20mg Tablet
Tamoxifen as Citrate…20mg"
Pharmacological Group Anti-oestrogens
Type of Form Form-5
Me-too status (with strength and TAMOXIFEN TABLETS 20MG by M/s REHMAN MEDICINE
dosage form) COMPANY PESHAWAR (Reg#014978)
GMP status Last inspection dated 12-01-2018 for grant of new DML,
Decision: Approved.
347. Name and address of manufacturer / "M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial Area,
Applicant Karachi, Pakistan"
Brand Name +Dosage Form + Strength Tenvira 1mg Tablet
Entecavir as monohydrate…1mg"
Type of Form Form-5
Pack size & Demanded Price 20‘s, 30‘s; As per PRC
Me-too status (with strength and Bvir 1mg Tablet manufactured by Bosch Pharmaceuticals, Karachi
dosage form) Reg. No. 55639
GMP status Last inspection dated 02-08-2018 concluding acceptable level of
compliance of cGMP Requirements at the time of inspection.
II
Remarks of the Evaluator In contrary to approved by the reference agencies/authorities
wherein the applied formulation is approved as Entecavir ―as
monohydrate‖ equal to 1mg, while you have applied for Entecavir
monohydrate equal to 1mg. Clarification is required in this regard.
Decision: Deferred for revision of formulation as per reference product.
348. Name and address of manufacturer / "M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial Area,
Applicant Karachi, Pakistan"
Brand Name +Dosage Form + Strength Tenvira 0.5mg Tablet
Entecavir as monohydrate…0.5mg"
Type of Form Form-5
Pack size & Demanded Price 20‘s, 30‘s; As per PRC
Me-too status (with strength and Bvir 0.5mg Tablet manufactured by Bosch Pharmaceuticals,
dosage form) Karachi Reg. No. 055638
GMP status Last inspection dated 02-08-2018 concluding acceptable level of
Remarks of the EvaluatorII  In contrary to approved by the reference agencies/authorities
wherein the applied formulation is approved as Entecavir ―as
monohydrate‖ equal to 0.5mg, while you have applied for
Entecavir monohydrate equal to 0.5mg. Clarification is
Decision: Deferred for revision of formulation as per reference product.
349. Name and address of manufacturer / "M/s Sami Pharmaceuticals Pvt Limited. F-95, S.I.T.E, Karachi,
Applicant Pakistan"
Brand Name +Dosage Form + Strength Afino 0.75mg Tablets
Everolimus……0.75mg"
Pharmacological Group Protein kinase inhibitor
Type of Form Form-5
Pack size & Demanded Price As per latest decision taken by DPC in respect of ususal/hardship
cases.
Me-too status (with strength and CERTICAN TABLETS 0.75MG by M/s NOVARTIS PHARMA,
GMP status Last inspection dated 14-06-2018 recommending issuance of GMP
certificate.
Applicant Pakistan"
Everolimus…….0.25mg"
Type of Form Form-5
cases.
certificate.
II
th
Applicant Pakistan"
Everolimus…….2.5mg"
Type of Form Form-5
cases.
Me-too status (with strength and AFINITOR 2.5MG TABLETS by M/s NOVARTIS PHARMA,
dosage form) Karachi (Reg. No. 078105)
certificate.
Applicant Pakistan"
Brand Name +Dosage Form + Strength Afino 10mg Tablets
Everolimus…….10mg"
Type of Form Form-5
Pack size & Demanded Price As per decision taken by DPC in respect of ususal/hardship cases.
Me-too status (with strength and AFINITOR 10MG TABLETS by M/s NOVARTIS PHARMA,
certificate.
Applicant Pakistan"
Brand Name +Dosage Form + Strength Afino 5mg Tablets
Everolimus…….5mg"
Type of Form Form-5
cases.
Me-too status (with strength and AFINITOR 5MG TABLETS by M/s NOVARTIS PHARMA,
certificate.
II

354. Name and address of manufacturer / "M/s Hiranis Pharmaceuticals (Pvt.) Ltd.Plot No. E-145 to E-149,
Applicant North Western Industrial Zone, Port Qasim, Karachi, Pakistan"
Brand Name +Dosage Form + Strength Evercan 0.75mg Tablet
Everolimus……0.75mg"
Type of Form Form-5
GMP status Last inspection dated 29-01-2019concluding overall GMP
compliant status.
355. Name and address of manufacturer / "M/s Hiranis Pharmaceuticals (Pvt.) Ltd.Plot No. E-145 to E-149,
Brand Name +Dosage Form + Strength Evercan 0.25mg Tablet
Everolimus…0.25mg"
Type of Form Form-5
GMP status Last inspection dated 29-01-2019concluding overall GMP
compliant status.
356. Name and address of manufacturer / "M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Applicant Estate, Lahore"
Brand Name +Dosage Form + Strength Mycophen 500mg Tablet
Mycophenolate mofetil……500mg"
Pharmacological Group Immunosuppressant
Type of Form Form-5
Approval status of product in Mycophenolate Mofetil 500 mg film-coated tablets by
Reference Regulatory Authorities Morningside Healthcare Ltd, Approved by MHRA
Me-too status (with strength and Mycophenol 500 mg Tablets by Wellborne
dosage form) Pharmachem and Biologicals, Hattar. Reg. No. 77412
GMP status GMP Certificate Issued on 27-08-2018
Decision:Approved.

357. Name and address of manufacturer / "M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Applicant Estate, Lahore"
Brand Name +Dosage Form + Strength Mimpara 30mg Tablet
Cinacalcet as HCL…30mg"
Pharmacological Group Anti-parathyroid agent
Type of Form Form-5
Me-too status (with strength and --
dosage form)
GMP status GMP Certificate Issued on 27-08-2018
Remarks of the EvaluatorII Submit stability data as per format decided by Registration Board
in its 278th meeting.
Decision: Deferred for submission of stability data as per format decided by Registration Board in its
278th meeting.
358. Name and address of manufacturer / "M/s Cunningham Pharmaceuticals Pvt Ltd. Plot # 81, Sunder
Applicant Industrial Estate, Raiwind Road Lahore, Pakistan"
Brand Name +Dosage Form + Strength Tacrim 1mg Capsule
Tacrolimus as Monohydrate…1mg
Diary No. Date of R & I & fee Dy.No 44501 dated 31-12-2018 Rs.20,000/- Dated 31-12-2018
Type of Form Form-5
Me-too status (with strength and dosage Inograf 1 mg capsule by Platinum Pharma (Reg.# 045491)
form)
GMP status GMP Certificate issued on 12-03-2018
Decision:Approved.
Brand Name +Dosage Form + Strength Tacrim 0.5mg Capsule
Tacrolimus as Monohydrate…0.5mg"
Type of Form Form-5
Me-too status (with strength and dosage Inograf 0.5 mg capsule by Platinum Pharma (Reg.# 045490)
form)
Decision:Approved.

Brand Name +Dosage Form + Strength Thalide 50mg Capsule
Thalidomide…50mg‘
Type of Form Form-5
Me-too status (with strength and dosage Thalido 50mg Capsules by M/s Atco (Reg.# 048589)
form)
Decision:Approved.
Brand Name +Dosage Form + Strength Suninit 25mg Capsule
Sunitnib as Sunitinib malate…25mg"
Pharmacological Group Anti-cancer
Type of Form Form-5
Me-too status (with strength and dosage SUTENT 25MG CAPSULE by M/s Pfizer (Reg.# 052226)
form)
Decision: Deferred for Evidence of approval of required manufacturing facility for ―Cytotoxic drugs‖
from CLB.
Brand Name +Dosage Form + Strength Suninit 12.5mg Capsule
Sunitnib as Sunitinib malate…12.5mg"
Type of Form Form-5
Me-too status (with strength and dosage SUTENT 12.5MG CAPSULE by M/s Pfizer (Reg.# 052225)
form)
V
from CLB.

Brand Name +Dosage Form + Strength Suninit 50mg Capsule
Sunitnib as Sunitinib malate…50mg"
Type of Form Form-5
Me-too status (with strength and dosage SUTENT 50MG CAPSULE by M/s Pfizer (Reg.# 052227)
form)
V
from CLB.
b. Availability of Drugs
The Board in its 277th meeting held on 27th - 29th, December, 2017 decided that for the
following molecules, which are generally reported to be in short supply and having limited or no
manufacturers/importers, the registration application shall have priority review process and
consideration by the Board to ensure their free availability.
a. Fludrocortisone 0.1 mg Tablet.
b. Amiodarone 100 & 200 mg Tablets, and 30mg/ml & 50mg/ml Injection.
c. Clobazam 10 mg Tablet.
d. Acetazolamide 250 Tablets.
e. Hydrochlorthiazide 25 mg & 50 mg Tablets.
f. Streptomycin 1 gram Injection.
g. Nitrofurantoin 50 mg & 100 mg Tablet.
Accordingly in 287th meeting of Registration Board the relevant applications from

available record were presented. Now following applications of above cited formulations have
been identified in record and are presented here for consideration of Board:
364. Name and address of manufacturer / "M/s Searle IV Solutions Pvt Ltd. 1.5 km, Manga Raiwind Road,
Applicant Lahore"
Brand Name +Dosage Form + Strength Actaglucom 250mg Tablet
Acetazolamide……250mg"
Pharmacological Group Carbonic anhydrase inhibitor
Type of Form Form-5
Me-too status Acetamide Tablets of M/s Werrick Pharma. (Reg.#025175)
Decision: Approved.
365. Name and address of manufacturer / "M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial Estate,
Brand Name +Dosage Form + Strength Acetamid Tablets 250mg

Composition "Each tablet contains:
Acetazolamide……250mg"
Type of Form Form-5
Pack size & Demanded Price 30‘s;As per SRO
GMP status 13-07-2017 for Grant of new DML
Decision: Approved.
366. Name and address of manufacturer / "M/s Sante Pvt Ltd A-97, S.I.T.E Super Highway, Karachi,
Applicant Pakistan"
Brand Name +Dosage Form + Strength Tazol 250mg Tablet
Acetazolamide…250mg"
Type of Form Form-5
Pack size & Demanded Price 100‘s; MRP Rs. 750/- 30‘s; MRP Rs. 350/-
GMP status Last inspection report dated 29-3-17 confirms satisfactory
compliance to GMP
Decision: Approved.
367. Name and address of manufacturer / "M/s Ameer & Adnan Pharmaceuticals Pvt. Limited, Plot No. 47,
Applicant Sunder Industrial Estate, Raiwind Road, Lahore."
Brand Name +Dosage Form + Strength Amedone 3ml injection
Amiodarone hydrochloride …… 150mg
Pharmacological Group Antiarrhythmic
Type of Form Form-5
Me-too status Cordaronex I.V Injection of M/s Khalid Brothers, Karachi
(Reg.# 010645)
report concludes the firm to be GMP compliant.
Decision: Approved.
Brand Name +Dosage Form + Strength Amedone 100mg tablets

Type of Form Form-5
Me-too status Amid Tablets of M/s. C.C.L Pharmaceuticals, (Pvt) Ltd (Reg.#
045973)
Decision: Approved.
369. Name and address of manufacturer / "M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km, GT Road Khori
Applicant Murredke, Sheikhupura"
Brand Name +Dosage Form + Strength Amiodarone HCl Injection 150mg/3ml
Amiodarone HCl …50mg"
Type of Form Form-5
Pack size & Demanded Price 3ml ampoule; As PRC
Me-too status Cordaronex I.V Injection of M/s Khalid Brothers, Karachi
(Reg.# 010645)
report concludes as under:
―Overall hygienic condition of firm is satisfactory at the time of
inspection. They were advised improve further their
documentation as mention in above. They agreed.‖
Decision: Approved.
Applicant Hattar"
Brand Name +Dosage Form + Strength Fribium 10mg Tablet
Clobazam ……10mg"
Pharmacological Group Benzodiazepine
Type of Form Form-5
Pack size & Demanded Price As PRC
Me-too status Frisium tablet of M/s Sanofi-Aventis (Reg.# 002694)
Decision: Deferred for evidence of approval of required manufacturing facility of ―Tablet
(Psychotropic) Section‖ from CLB.
371. Name and address of manufacturer / "M/s Tabros Pharma Pvt Ltd. L-20/B,Sector-22, Federal B
Brand Name +Dosage Form + Strength Fludrocort 0.1mg Tablet
Fludrocortisone Acetate…0.1mg"
Pharmacological Group Mineralocorticoid

Type of Form Form-5
Pack size & Demanded Price Rs. 6.25mg per tablet
Rs. 125mg per 20‘s
Me-too status --
GMP status Last inspection report 07-02-2018 concluding as under:
On the basis of current inspection it was observed that the firm
rectified all observations noted during last GMP Inspection
Remarks of the Evaluator2  Evidence of required manufacturing facility required.
 Evidence of me-too status required.
 Evidence of approval of required manufacturing facility for applied formulation from CLB.
Brand Name +Dosage Form + Strength Amedone 200mg tablets
Type of Form Form-5
Me-too status Amid Tablets of M/s. C.C.L Pharmaceuticals, (Pvt) Ltd (Reg.#
045972)
2
Decision: Approved.
c. Export Facilitation.
Assistant Director (Reg-II) vide letter no. F.5-85/2013-Reg-V (Vol-I) dated 25-02-2019, has declared that M/s
CCL Pharmaceutical (Pvt.) Ltd, Lahore has claimed for export of USD 40,20,355/- during the fiscal year 2017-18,
achieved the benchmark as defined in the Board‘s decision. The firm has requested for priority
evaluation/consideration of their following applications.
373. Name and address of manufacturer / "M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial Estate,Kot
Applicant Lakhpat, Lahore"
Brand Name +Dosage Form + Strength Xalia 2.5mg Tablet
Rivaroxaban….…2.5mg"
Pharmacological Group Antithrombic agent
Type of Form Form-5
Finished product Specifications Innovator‘s specification
Approval status of product in Xarelto of M/s Bayer healthcare approved by EMA
Me-too status (with strength and Xarelto 2.5mg Tablet by M/s. Bayer Pakistan (private) limited
dosage form) (Reg#074794)
GMP status Firm has submitted copy of GMP inspection report conducted on

08-03-2017 & 31-03-2017, concluding the firm was found to be
operating at satisfactory level of GMP compliance
Brand Name +Dosage Form + Strength Doxyline Capsule 50mg
Doxycycline Hyclate eq. to Doxycyxline……50mg"
Pharmacological Group Tetracycline
Type of Form Form-5
Me-too status (with strength and Doxinom-50 Capsules by M/s. Genome Pharmaceuticals (Pvt.)
dosage form) Ltd (Reg#060832)
Decision: Approved.
Brand Name +Dosage Form + Strength Doxyline Capsule 100mg
Doxycycline Hyclate eq. to Doxycyxline……100mg"
Type of Form Form-5
Me-too status (with strength and Doxinom-100 Capsules by M/s. Genome Pharmaceuticals (Pvt.)
dosage form) Ltd (Reg#056095)
Decision:Approved.
Brand Name +Dosage Form + Strength Vcon Tablet 200mg
Voriconazole……200mg"
Pharmacological Group Anti-mycotic
Type of Form Form-5
Approval status of product in Approved by MHRA
Me-too status (with strength and Vorinaz Tablet by M/s Atco Lab. Karachi (Reg.# 081097)
dosage form)
II
Decision:Approved.

Brand Name +Dosage Form + Strength Qutyl XR 300mg Tablet
Quetiapine Fumarate Eq. to Quetiapine…300mg"
Pharmacological Group Anti-psychotic
Type of Form Form-5
Me-too status (with strength and Quit XR 300 mg Tablets by M/s. Navegal Laboratories (Reg.#
Decision:Approved.
Type of Form Form-5
Me-too status (with strength and Pine XR Tablet by M/s. Werrick Pharmaceuticals (Reg.# 082047)
dosage form)
Decision:Approved.
Type of Form Form-5
Me-too status (with strength and Qusel XR 150mg tablet of M. Ray Pharma (Reg.#067501)
dosage form)
Decision:Approved.
380. Name and address of Applicant "M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial Estate, Kot
Lakhpat, Lahore.‖
Detail of Drug Sale License N/A
Name and address of manufacturer M/s Phil Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP,

Thuan An District, Binh Duong, Vietnam
Name and address of marketing M/s Phil Inter Pharma Co. Ltd., No. 20, Huu Nghi Blvd., VSIP,
authorization holder Thuan An District, Binh Duong, Vietnam.
Number of product license and date of issue: VD-30864-18 dated
05th July, 2018.
Name of exporting country Vietnam
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No 35872 Dated 29-10-2018
Fee including differential fee Rs. 100,000/- Dated 29-10-2018
Brand Name +Dosage Form + Strength Isotret 10mg Soft Gelatin capsule
Composition "Each softgel capsule contains:
Isotretinoin…….10mg"
Finished Product Specification Manufacturer specifications.
Pharmacological Group Retinoic for treatment of acne
Shelf life 3 years
Demanded Price As per brand leader
Pack size
International availability Approved by USFDA
Me-too status Acnotin 10 Soft Gelatin Capsules of M/s Ferozsons Laboratories
Ltd, (Reg.# 070318)
Stability studies  Long term stability studies of 36 months and Accelerated
stability studies of 6 months of three batches at Zone-IV A
conditions.
Detail of certificates attached  Original Legalized Free Sale certificate issued by Ministry of
Health Vietnam, Drug Administration valid upto 05-07-2023.
 Original Legalized CoPP (Certificate#. 692/GP-QLP) issued
on 14-08-2018 by Ministry of Health Vietnam, Drug
Administration, declaring the free sale of applied product and
GMP compliant status of the manufacturer i.e., M/s Phil Inter
Pharma Co. Ltd., No. 25, Street No. 8, VSIP, Thuan An District,
Binh Duong, Vietnam
 Legalized copy of GMP certificate issued by Ministry of
Health Vietnam, Drug Administration, in the name of M/s Phil
Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP, Thuan An
District, Binh Duong, Vietnam valid for three years from date of
approval.
 Copy of ―Letter of Authorization‖ from M/s Phil Inter
Pharma Co. Ltd., No. 20, Huu Nghi Blvd., VSIP, Thuan An
District, Binh Duong, Vietnam authorising M/s CCL
Pharmaceuticals Pvt Ltd. 62 Industrial Estate, Kot Lakhpat,
Lahore to carry out registration process in Pakistan for applied
product.
Remarks of the Evaluator:
Sr. Observations Response of Firm

# (Communicated vide letter No. F.1- (Received vide letter No. CCL/19/R-242 dated 06-05-
1/2017/PEC-DRAP (AD PEC-II dated 11- 2019)
04-2019))
i. Clarification shall be submitted whether Firm has submitted revised Form 5-A with following
application is for ―Finished details:
pharmaceutical product import‖ or ―Bulk Name and address of the indenter or agent:
import and local repack‖, since it is not "M/s CCL Pharmaceuticals Pvt Ltd. 65-Industrial
evident form the submitted Form-5A. Estate, Kot Lakhpat, Lahore.‖
Name and address of the manufacturer of drug:
―M/s Phil Inter Pharma Co. Ltd., No. 25, Street No. 8,

VSIP, Thuan An District, Binh Duong, Vietnam‖
Bulk Import and local repack at:
M/s CCL Pharmaceuticals Pvt Ltd. 62-Industrial Estate,
Kot Lakhpat, Lahore.
 The undertaking of Form 5-A endures scanned
signature and stamp of the manufacturer i.e., M/s Phil
Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP,
Thuan An District, Binh Duong, Vietnam.
 The fee voucher has been submitted by the
DML no. 000052, which is for the M/s CCL
Pharmaceuticals Pvt Ltd. 62-Industrial Estate, Kot
Lakhpat, Lahore, whereas revised Form 5-A has been
submitted by M/s CCL Pharmaceuticals Pvt Ltd. 65-
Industrial Estate, Kot Lakhpat, Lahore
ii. Manufacturer has referred finished Revised technical specifications of finished product
product specifications as in-house, have been submitted as per USP monograph for the
whereas USP and BP monograph is Isotretinoin capsules.
available for applied formulation. This revised document does not have any signatures or
Clarification shall be submitted in this revision/effective date.
regard
iii. Finished product specifications submitted Revised finished product testing method has been
from manufacturer of applied formulation submitted wherein dissolution test as per USP test 2
does not contain dissolution test. from USP monograph for the Isotretinoin capsules has
Clarification/Justification shall be been mentioned.
submitted in this regard.
iv. Dissolution test has not been performed Revised stability study reports have been submitted for
during the stability studies. three batches as per Zone IV-b conditions wherein
Clarification/justification shall be dissolution test and its results have been mentioned
submitted in this regard.  It is pertinent to mention that revised stability
study reports submitted by firm for the long term
conditions contains the same results as presented in
stability study reports submitted along with original
dossier, in respect of various tests, batch numbers, test
date etc, while the only difference is the inclusion of
Dissolution tests and its results.
 Submitted data of stability studies submitted from manufacturer reveal that stability has been performed
with packaging of 1000 capsules per aluminium poly bag-bulk packaging.
Decision: Deferred for following observations:
 The undertaking of Form 5-A endures scanned signature and stamp of the manufacturer i.e.,
M/s Phil Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP, Thuan An District, Binh Duong, Vietnam.
 The fee voucher has been submitted by the DML no. 000052, which is for the M/s CCL
Pharmaceuticals Pvt Ltd. 62-Industrial Estate, Kot Lakhpat, Lahore, whereas revised Form 5-A has
been submitted by M/s CCL Pharmaceuticals Pvt Ltd. 65-Industrial Estate, Kot Lakhpat, Lahore.
 Revised stability study reports submitted by firm for the long term conditions contains the
same results as presented in stability study reports submitted along with original dossier, in respect
of various tests, batch numbers, test date etc, while the only difference is the inclusion of Dissolution
tests and its results.
381. Name and address of Applicant "M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial Estate, Kot
Lakhpat, Lahore
Detail of Drug Sale License N/A
Name and address of manufacturer M/s Phil Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP,
Thuan An District, Binh Duong, Vietnam
Name and address of marketing M/s Phil Inter Pharma Co. Ltd., No. 20, Huu Nghi Blvd., VSIP,
authorization holder Thuan An District, Binh Duong, Vietnam.
Number of product license and date of issue: VD-30864-18 dated
05th July, 2018.
Name of exporting country Vietnam
Brand Name +Dosage Form + Strength Isotret 20mg Soft Gelatin capsule
Composition "Each softgel capsule contains:
Isotretinoin…….20mg"
Pharmacological Group Retinoic for treatment of acne
Shelf life 3 years
Demanded Price
Pack size As per brand leader
International availability Approved by USFDA
Me-too status Acnotin 20 Soft Gelatin Capsules of M/s Ferozsons Laboratories
Ltd, (Reg.# 070319)
Stability studies  Long term stability studies of 36 months and Accelerated
stability studies of 6 months of three batches at Zone-IV A
conditions.
Detail of certificates attached  Original Legalized Free Sale certificate issued by Ministry
of Health Vietnam, Drug Administration valid upto 05-07-2023.
 Original Legalized CoPP (Certificate#. 692/GP-QLP)
issued on 14-08-2018 by Ministry of Health Vietnam, Drug
Administration, declaring the free sale of applied product and
GMP compliant status of the manufacturer i.e., M/s Phil Inter
Pharma Co. Ltd., No. 25, Street No. 8, VSIP, Thuan An District,
Binh Duong, Vietnam
 Legalized copy of GMP certificate issued by Ministry of
Health Vietnam, Drug Administration, in the name of M/s Phil
Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP, Thuan An
District, Binh Duong, Vietnam valid for three years from date of
approval.
 Copy of ―Letter of Authorization‖ from M/s Phil Inter
Pharma Co. Ltd., No. 20, Huu Nghi Blvd., VSIP, Thuan An
District, Binh Duong, Vietnam authorising M/s CCL
Pharmaceuticals Pvt Ltd. 62 Industrial Estate, Kot Lakhpat,
Lahore to carry out registration process in Pakistan for applied
product.
Sr. Observations Response of Firm
# (Communicated vide letter No. (Received vide letter No. CCL/19/R-242 dated 06-05-2019)
F.1-1/2017/PEC-DRAP (AD
PEC-II dated 11-04-2019))
i. Clarification shall be submitted Firm has submitted revised Form 5-A with following details:
whether application is for Name and address of the indenter or agent:
―Finished pharmaceutical "M/s CCL Pharmaceuticals Pvt Ltd. 65-Industrial Estate, Kot
product import‖ or ―Bulk import Lakhpat, Lahore.‖
and local repack‖, since it is not Name and address of the manufacturer of drug:
evident form the submitted ―M/s Phil Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP,
Form-5A. Thuan An District, Binh Duong, Vietnam‖
Bulk Import and local repack at:
M/s CCL Pharmaceuticals Pvt Ltd. 62-Industrial Estate, Kot
Lakhpat, Lahore.
 The undertaking of Form 5-A endures scanned signature
and stamp of the manufacturer i.e., M/s Phil Inter Pharma Co.
Ltd., No. 25, Street No. 8, VSIP, Thuan An District, Binh

Duong, Vietnam.
 The fee voucher has been submitted by the DML no.
000052, which is for the M/s CCL Pharmaceuticals Pvt Ltd. 62-
Industrial Estate, Kot Lakhpat, Lahore, whereas revised Form 5-
A has been submitted by M/s CCL Pharmaceuticals Pvt Ltd. 65-
Industrial Estate, Kot Lakhpat, Lahore
ii. Manufacturer has referred Revised technical specifications of finished product have been
finished product specifications submitted as per USP monograph for the Isotretinoin capsules.
as in-house, whereas USP and This revised document does not have any signatures or
BP monograph is available for revision/effective date.
applied formulation.
Clarification shall be submitted
in this regard
iii. Finished product specifications Revised finished product testing method has been submitted
submitted from manufacturer of wherein dissolution test as per USP test 2 from USP monograph
applied formulation does not for the Isotretinoin capsules has been mentioned.
contain dissolution test.
Clarification/Justification shall
be submitted in this regard.
iv. Dissolution test has not been Revised stability study reports have been submitted for three
performed during the stability batches as per Zone IV-b conditions wherein dissolution test and
studies. its results have been mentioned
Clarification/justification shall  It is pertinent to mention that revised stability study
be submitted in this regard. reports submitted by firm for the long term conditions contains
the same results as presented in stability study reports submitted
along with original dossier, in respect of various tests, batch
numbers, test date etc, while the only difference is the inclusion
of Dissolution tests and its results.
 Submitted data of stability studies submitted from manufacturer reveal that stability has been performed
with packaging of 1000 capsules per aluminium poly bag-bulk packaging.
 The undertaking of Form 5-A endures scanned signature and stamp of the manufacturer i.e.,
M/s Phil Inter Pharma Co. Ltd., No. 25, Street No. 8, VSIP, Thuan An District, Binh Duong, Vietnam.
 The fee voucher has been submitted by the DML no. 000052, which is for the M/s CCL
Pharmaceuticals Pvt Ltd. 62-Industrial Estate, Kot Lakhpat, Lahore, whereas revised Form 5-A has
been submitted by M/s CCL Pharmaceuticals Pvt Ltd. 65-Industrial Estate, Kot Lakhpat, Lahore.
 Revised stability study reports submitted by firm for the long term conditions contains the
same results as presented in stability study reports submitted along with original dossier, in respect
of various tests, batch numbers, test date etc, while the only difference is the inclusion of Dissolution
tests and its results.
Assistant Director (Reg-V) vide letter dated 08-01-2019, has declared that M/s Schazoo Zaka Pvt. Ltd.
Sheikhupura has claimed for 3 molecules to be considered on priority against USD 327564/- during the fiscal year
July 2017-June 2018, duly verified from submitted documents (Form E GD) as per decision of Registration Board.
382. Name and address of manufacturer / M/s Schazoo Zaka Pvt. Ltd. Sheikhupura
Applicant
Brand Name +Dosage Form + Strength Alerda-D tablets
Desloratadine………5mg"
Pharmacological Group Anti-allergic
Type of Form Form-5
Pack size & Demanded Price Rs. 13 per tablet

Me-too status (with strength and Desdine 5mg Tablet of M/s M/s Hygeia Pharmaceuticals,
dosage form) Islamabad (Reg.# 080821)
GMP status GMP Certificate issued on the basis of inspection dated 26-06-
2018 & 27-06-2018 with following sections:
1- Tablet (Gen, Anti TB)
2- Capsule (Gen)
3- Dry Powder suspension (Gen, Anti TB)
4- Sachet (Gen, Anti TB).
Remarks of the EvaluatorII Firm has requested to consider the above applied product in
replacement of their previously submitted application of
Roflumilast molecule since stability data is required for that.
Decision:Approved.
d. Import Applications of Priority Categories Defined by Registration Board in 257th

meeting.
i. Human
383. Name and address of Applicant M/s Pharmatec Pakistan (Pvt.) Ltd., D-86/A, Manghopir Road,
S.I.T.E., Karachi-75700, Pakistan
Detail of Drug Sale License Address: M/s Pharmatec Pakistan (Pvt.) Ltd., D-86/A, Manghopir
Road, S.I.T.E., Karachi-75700, Pakistan
Validity: 22-06-2019
Status: License to sell drugs by way of ―Whole Sale‖
Name and address of manufacturer M/s CENEXI, 52, rue Marcel et Jacques Gaucher, 94120
Fontenay-sous-Bois, France
Name and address of marketing M/s Stragen Nordic A/S HelsingØrsgade 8C, HillerØd, Denmark
authorization holder
Name of exporting country Germany
Diary No. & Date of R& I Dy. No. 30408 Dated 10-09-2018
Brand Name +Dosage Form + Strength Urapidil Stragen I.V 50mg/10ml (Solution for Injection)
Urapidil ……. 10mg
Pharmacological Group Alpha-adrenoceptor antagonist
Shelf life 18 months
Demanded Price Rs. 8,000/- per 5‘s
Pack size 5 ampoules
International availability Approved by ANSM of France
Me-too status N/A
Detail of certificates attached  Original Legalized CoPP
Certificate No: 2286/1
Certifying Authority: District Government of Cologne,
Deaprtment 24, Zeughausstrae 2-10, 50667 Cologne. (The name
of issuing authority is included in the WHO list of ―Competent
authorities of countries participating in the WHO certification
scheme on the quality of pharmaceutical products moving in
international commerce‖
https://www.who.int/medicines/areas/quality_safety/regulation_le
gislation/certification/contacts/en/index1.html as accessed on 19-
12-2018)
Issue Date: 10-07-2018
Free sale in exporting country: Yes
Applicant of certificate: M/s Stragen Pharma GmbH,
Technologie Park Koln, eupener Strasse 135-137, 50933,
Cologne, Germany.
 GMP: No
 Applicant of certificate: M/s Stragen Pharma GmbH,
technologie Park Koln, Eupener Strasse 135-137, 50933,
Cologne, Germany
 Original legalized GMP Certificate
Certificate no. HPF/FR/168/2017 valid upto 22-03-2020
Manufacturer Address: M/s CENEXI – Fontenay Sous Bois, 52,
rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois,
France
Issued by French National Agency for Medicines and Health
Products Safety.
 Firm has submitted an Original legalized statement from M/s Stragen Pharma SA, Switzerland declaring
M/s Stragen Nordic A/S Denmark (Product License Holder) an affiliate of M/s Stragen Pharma SA,
Switzerland. The statement further grants the M/s Pharmatech Pakistan (Pvt.) Ltd, right to register and to
commercialize, the finished product in Pakistan under Stragen Pharma‘s trademark.
 Copy of ―License and Supply Agreement‖ has been submitted between the applicant and M/s Stargen
Pharma S.A., Switzerland.
 Applicant for COPP is different from Product License Holder.
 Only Long term stabilities data for three batches as per Zone IV-A conditions have been submitted by
applying bracketing principle on 5ml & 20 ml ampoule
Decision: Registration Board deferred the case for evaluation of bracketing principle applied by the
firm on ―long term stabilities data‖ in view of applicable ICH guidelines and presentation of complete
details before the Board.
384. Name and address of Applicant M/s Pharmatec Pakistan (Pvt.) Ltd., D-86/A, Manghopir Road,
S.I.T.E., Karachi-75700, Pakistan
Detail of Drug Sale License Address: M/s Pharmatec Pakistan (Pvt.) Ltd., D-86/A, Manghopir
Road, S.I.T.E., Karachi-75700, Pakistan
Status: License to sell drugs by way of ―Whole Sale‖
Name and address of manufacturer M/s CENEXI, 52, rue Marcel et Jacques Gaucher, 94120
Fontenay-sous-Bois, France
Name and address of marketing M/s Stragen Nordic A/S HelsingØrsgade 8C, HillerØd, Denmark
Diary No. & Date of R& I Dy. No. 30409 Dated 10-09-2018
Brand Name +Dosage Form + Strength Urapidil Stragen I.V 25mg/5ml (Solution for Injection)
Urapidil ……. 25mg
Pharmacological Group Alpha-adrenoceptor antagonist
Demanded Price Rs. 4,000/- per 5‘s
Pack size 5 ampoules
International availability Approved by ANSM of France
Me-too status N/A
Detail of certificates attached  Original Legalized CoPP
Certifying Authority: District Government of Cologne,
Deaprtment 24, Zeughausstrae 2-10, 50667 Cologne. (The name
of issuing authority is included in the WHO list of ―Competent
authorities of countries participating in the WHO certification
scheme on the quality of pharmaceutical products moving in
international commerce‖
https://www.who.int/medicines/areas/quality_safety/regulation_le
gislation/certification/contacts/en/index1.html as accessed on 19-
12-2018)
Free sale in exporting country: Yes
 GMP: No
 Applicant of certificate: M/s Stragen Pharma GmbH,
technologie Park Koln, Eupener Strasse 135-137, 50933,
Cologne, Germany
 Original legalized GMP Certificate
Certificate no. HPF/FR/168/2017 valid upto 22-03-2020
Manufacturer Address: M/s CENEXI – Fontenay Sous Bois, 52,
rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois,
France
Issued by French National Agency for Medicines and Health
Products Safety.
 Firm has submitted a Original legalized statement from M/s Stragen Pharma SA, Switzerland declaring
M/s Stragen Nordic A/S Denmark (Product License Holder) an affiliate of M/s Stragen Pharma SA,
Switzerland. The statement further grants the M/s Pharmatech Pakistan (Pvt.) Ltd, right to register and to
commercialize, the finished product in Pakistan under Stragen Pharma‘s trademark.
 Applicant for COPP is different from Product License Holder.
 Only Long term stabilities data for three batches as per Zone IV-A conditions have been submitted by
applying bracketing principle on 5ml & 20 ml ampoule.
Decision: Registration Board deferred the case for evaluation of bracketing principle applied by the
firm on ―long term stabilities data‖ in view of applicable ICH guidelines and presentation of complete
details before the Board.
385. Name and address of Applicant "M/s RG Pharmaceuticals Pvt Ltd. 703, Progressive Square,
P.EC.H.S., Block-6, Shahrah-e-Faisal, Karachi, Pakistan
Detail of Drug Sale License Address: M/s RG Pharmaceutica Pvt Ltd. 703, Progressive Square,
P.EC.H.S., Block-6, Shahrah-e-Faisal, Karachi, Pakistan Validity:
17-01-2021
Status: Drug License by way of WholeSale.
Name and address of manufacturer M/s Hanlim Pharm. Co., Ltd. 2-27, Yeongmun-Ro, Cheoin-Gu,
Yongin-Si, Gyeonggi-do, Republic of Korea"
Name and address of marketing M/s Hanlim Pharm. Co., Ltd. 2-27, Yeongmun-Ro, Cheoin-Gu,
authorization holder Yongin-Si, Gyeonggi-do, Republic of Korea"
Name of exporting country Korea
Brand Name+Dosage Form+Strength Carbella 0.01% Solution for Injection
Carbetocin…….100µg"
Pharmacological Group Oxytocin & analogue (indicated for the prevention of uterine atony
following delivery of the infant by Caesarean section under
epidural or spinal anaesthesia)
Shelf life 36 months: Store in a refrigerator 2oC to 8oC.
Demanded Price
Pack size 1ml glass ampoule x 5‘s

International availability PABAL 100 micrograms/ml solution for injection of M/s Ferring
Pharmaceuticals Ltd. approved by MHRA of UK.
Me-too status N/A
Stability studies Firm has submitted long term (36 months) at 2 oC - 8oC &
accelerated (06 months) stability data at 25+ 2oC, 60+ 5% RH for
three batches.
Detail of certificates attached  Original Legalized CoPP (Certificate#. 2018-D1-1220)
issued on 29-05-2018 by Gyeongin Regional Food and Drug
Administration, Korea, declaring the free sale of applied
product and GMP compliant status of the manufacturer i.e.,
M/s Hanlim Pharm. Co., Ltd. 2-27, Yeongmun-Ro, Cheoin-
Gu, Yongin-Si, Gyeonggi-do, Republic of Korea.
 Original legalized GMP certificate issued by Commissioner
ofGyeongin Regional office of Food and Drug Safety for the
M/s Hanlim Pharm. Co., Ltd. 2-27, Yeongmun-Ro, Cheoin-
Gu, Yongin-Si, Gyeonggi-do, Republic of Korea, valid till 18-
12-2019.
 Original Notarized ―Letter of Authorization‖ from M/s
Hanlim Pharm. Co., Ltd. 2-27, Yeongmun-Ro, Cheoin-Gu,
Yongin-Si, Gyeonggi-do, Republic of Korea declaring M/s RG
Pharmaceutica Pvt Ltd. 703, Progressive Square, P.EC.H.S.,
Block-6, Shahrah-e-Faisal, Karachi, Pakistan as sole and
exclusive distributor of applied product in aterritory defined as
Pakistan.
Remarks of the Evaluator.  The application has been forwarded by Dir. Biological Drugs,
vide letter no. F.3-54/2017-AD (BD)EVN/RG dated 30-10-
2018, stating as under:
―During evaluation, it is observed that the active substance
Carbetocin is a synthetic analogue and not a biological
substance. MHRA assessment report of Pabal 100 µg/ml
(Carbetocin) clearly indicates that the Carbetocin is a synthetic
analogue and manufactured by synthetic method.‖
Decision: Approved with Innovator‘s specifications.as per Policy for inspection of Manufacturer
abroad.
386. Name and address of Applicant "M/s Punjab Medical Services, Office No: 4/5 2, Floor jala Center
Opp, OPC Gate Gangaram Hospital Mozang Road Lahore.
Detail of Drug Sale License Address: M/s Punjab medical Services Pharmacy, Sharif mansion
near ganga ram Hospital, 16-Queens Road Lahore
License no.: 05-352-0063-01231P
Status: License to sell Drugs in a Pharmacy.
Name and address of manufacturer M/s Onko Ilac Sanayi ve Ticaret A.S Gebze Organize Sanayi
Bolgesi, 1700 sokak, No:1703,Gebze Kocaeli, Turkey
Name and address of marketing M/s Onko Ilac Sanayi ve Tic A.S kosuyolu cad No: 34, 34718
authorization holder Kosuyolu kadikoy, Istanbul, Turkey.
Name of exporting country Turkey
Brand Name +Dosage Form + Exetu 25mg film coated tablets
Strength
Exemestane...… 25mg"
Pharmacological Group Anti-neoplastic agents. ATC code: L02BG06
Demanded Price As per SRO
Pack size --
International availability Approved by EMA (European Medicine Agency)
Me-too status N/A
Stability studies Firm has submitted long term (36 months) at 30+ 2oC, 65+ 5% RH
& accelerated (06 months) stability data at 40+ 2oC, 75+ 5% RH
for three batches.
Detail of certificates attached  Original Legalized CoPP (Certificate no.: 2018/1248) issued
on 27-03-2018 by Ministry of Healthy Turkish Medicines and
Medical Devices Agency, declaring the free sale of applied
product in the exporting country i.e., Turkey and the GMP
compliant status of the manufacturer.
 Original Legalized GMP certificate (Certificate#
TR/GMP/2017/188) issued by Ministry of Healthy Turkish
Medicines and Medical Devices Agency in the name of M/s
Onko Ilac Sanayi ve Tic A.S kosuyolu cad No: 34, 34718
Kosuyolu kadikoy, Istanbul, Turkey. valid upto May, 2019.
 Copy of ―Letter of Authorization‖ by Onko İlaç Sanayi ve
Ticaret A.Ş located at Koşuyolu Cad. No: 34, 34718, Kadiköy
Istanbul, Turkey, issued in the name of M/s Punjab medical
Services on 22-03-2018 and valid for 3 years is submitted by
the firm.
abroad.
Case No. 05: Registration Applications of Import Cases.

a. New Cases (Veterinary)
387. Name and address of Applicant "M/s Samara Store, C-140, Block-D, Unit # 6, Latifabad,
Hyderabad, Pakistan‖
Detail of Drug Sale License Address: M/s Samara Medical Store, Shop No. 17 Qamar
Market Unit No. 07 Latifabad, Hyderabad.
Status: License to sell, stock and exhibition for sale, distribute
drugs by way of retail sale.
Name and address of manufacturer M/s The Arab Pecticides & Veterinary Drugs Mfg. Co.
Factory/El-Hassan Industrial Estate-Ibrid, Jordan
Name and address of marketing M/s The Arab Pecticides & Veterinary Drugs Mfg. Co.
authorization holder Factory/El-Hassan Industrial Estate-Ibrid, Jordan
Registration No. 42/5/2005
Registration date: 16/06/2005
Re-Registration date: 27-08-2015dated 13-09-1996
Name of exporting country Jordan
Diary No. & Date of R& I Dy. No10671 Dated 23-03-2018
Rs. 50,000/- Dated 15-04-2019
Brand Name +Dosage Form + Strength Tilmotil oral solution
Tilmicosin (as Tlimicosin phospahte) ……. 250mg

Shelf life 36 months if stored at a temperature below 30oC
Demanded Price De-controlled
Pack size 120ml & 240ml.
International availability Not applicable
Me-too status Tilcosin Solution of M/s Selmore Pharmaceuticals (PVT) LTD.,
Stability studies Firm has submitted long term (36 months) accelerated (06
months) stability data for three batches as per Zone IV-a
conditions.
Detail of certificates attached  Original& Legalized Certificate issued by Minister of
Agriculture & Minister of Environment, (Ministry of
Agriculture/Veterinary Department) issued on 27-03-2019
declaring that applied product is produced by M/s The Arab
Pesticides & Veterinary Drugs Mfg. Co. under the same
name, composition and pack and is used at the country of
origin (Jordan),
 Original & Legalized GMP certificate (004287) issued
byMinister of Agriculture in the name of M/s The Arab
Pecticides & Veterinary Drugs Mfg. Co. Factory/El-Hassan
Industrial Estate-Ibrid, Jordan, valid for three years from
date of issue i.e., 27-03-2019.
 Copy of Exclusive agency agreement has been submitted.
abroad.
388. Name and address of Applicant "M/s Samara Store, C-140, Block-D, Unit # 6, Latifabad,
Hyderabad, Pakistan‖
Detail of Drug Sale License Address: M/s Samara Medical Store, Shop No. 17 Qamar
Market Unit No. 07 Latifabad, Hyderabad.
Status: License to sell, stock and exhibition for sale, distribute
drugs by way of retail sale.
Name and address of manufacturer M/s The Arab Pecticides & Veterinary Drugs Mfg. Co.
Factory/El-Hassan Industrial Estate-Ibrid, Jordan
Name and address of marketing M/s The Arab Pecticides & Veterinary Drugs Mfg. Co.
authorization holder Factory/El-Hassan Industrial Estate-Ibrid, Jordan
Registration No. 42/5/2005
Registration date: 16/06/2005
Re-Registration date: 27-08-2015dated 13-09-1996
Name of exporting country Jordan
Diary No. & Date of R& I Dy. No10672 Dated 23-03-2018
Rs. 50,000/- Dated 15-04-2019
Brand Name +Dosage Form + Strength Colivet 4.8 water soluble powder
Colistin sulphate ……… 4.8 mIU
Shelf life 36 months if stored at a temperature below 30oC
Demanded Price De-controlled
Pack size 100gm, 500gm, 1Kg
International availability Not applicable
Me-too status COLAK POWDER of M/s A & K Pharmaceutical Faisalabad
(Reg.# 049796)
Stability studies Firm has submitted long term (36 months) accelerated (06
months) stability data for three batches as per Zone IV-a
conditions.
Detail of certificates attached  Original& Legalized Certificate issued by Minister of
Agriculture & Minister of Environment, (Ministry of
Agriculture/Veterinary Department) issued on 27-03-2019
declaring that applied product is produced by M/s The Arab
Pesticides & Veterinary Drugs Mfg. Co. under the same
name, composition and pack and is used at the country of
origin (Jordan),
 Original & Legalized GMP certificate (004287) issued
byMinister of Agriculture in the name of M/s The Arab
Pecticides & Veterinary Drugs Mfg. Co. Factory/El-Hassan
Industrial Estate-Ibrid, Jordan, valid for three years from
date of issue i.e., 27-03-2019.
 Copy of Exclusive agency agreement has been submitted.
Remarks of the Evaluator.  Notarized Copy of Exclusive agency agreementt shall be
submitted.
abroad.
b. Deferred Cases.
i. Human.
389. Name and address of Applicant M/s Fabnos International 26-C, Tauheed commercial area, street
No. 26 Phase V, DHA Karachi
Detail of Drug Sale License Address: Fabnos International, 26/C, Ist floor, Tauheed Comm,
Area, 26th street Phase V, Karachi
Name and address of manufacturer M/s Productora Y Comercializadora Odontologica New Stetic
S.A., Guarine, Antioquia, Carrera 53N 50-09, Autopista
Medellin-Bogota kilometro 22 Guarne Antioquia, Colombia,
South America
Name and address of marketing M/s Productora Y Comercializadora Odontologica New Stetic
authorization holder S.A., Guarine, Antioquia‖
Rs. 85000/- Dated 30-04-14
Brand Name +Dosage Form + Strength Lidocaine 2%
Composition Each dental cartridge of 1.8ml contains:
Lidocaine hydrochloride …… 36mg
Pharmacological Group Anaesthetic
Shelf life 2 years
Demanded Price & Pack size 14$ per cartridge/ Glass cartridge of 1.8ml
International availability --
Me-too status --
Previous remarks of evaluator  International availability not confirmed.
 Me-too status not confirmed
 Legalized COPP need to be submitted, Firm has
submitted copy of COPP.

Previous decision Registration board in its 254th meeting Deferred for:
 Submission of Legalized COPP.
 Confirmation of availability in reference drug
authorities.
 Confirmation of me-too status.
 Stability studies as per ICH/WHO Zone IV-A
conditions.
Evaluation by PEC Firm Has Submitted Following:
 Legalized Copy Of ―COPP‖ Both In Spanish And With
English Translation (Certificate# 2018005595) Issued By
―National Institute For The Surveillance Of Medications And
Foods‖, Ministry Of Health And Social Protection, Republic
Of Colombia.
 Following Particulars Are Evident Form The Submitted
Copp:
 Free Sale Status In The Exporting Country I.E.,
Colombia: Available
 Market Authorization Holder: ―M/s Productora Y
Comercializadora Odontologica New Stetic S.A.,
Guarine, Antioquia‖
 Product Authorization Number: INVIMA 2012m-
004009 R4
 Manufcaturer: M/s Productora Y Comercializadora
Odontologica New Stetic S.A., Guarine, Antioquia
 GMP status of manufacturer: Compliant
 Issue don: 10-04-2018

Long term (36 months) & accelerated (06 months) stability
studies data has been submitted for three batches as per Zone-
IV b conditions.
Decision: Approved as per Policy for inspection of Manufacturer abroad.
390. Name and address of Applicant M/s Fabnos International 26-C, Tauheed commercial area, street
No. 26 Phase V, DHA Karachi
Detail of Drug Sale License Address: Fabnos International, 26/C, Ist floor, Tauheed Comm,
Area, 26th street Phase V, Karachi
Name and address of manufacturer M/s Productora Y Comercializadora Odontologica New Stetic
S.A., Guarine, Antioquia
Name and address of marketing M/s Productora Y Comercializadora Odontologica New Stetic
authorization holder S.A., Guarine, Antioquia‖
Rs. 85000/- Dated 30-04-14
Brand Name +Dosage Form + Strength Lidocaine 2% E80
Composition Each dental cartridge of 1.8ml contains:
Lidocaine ashydrochloride……36mg
Epinephrine….0.2250mg
Shelf life 2 years
Demanded Price & Pack size 14$ per cartridge/ Glass cartridge of 1.8ml
International availability --
Me-too status --
Previous remarks of evaluator  International availability not confirmed.
 Me-too status not confirmed
 Legalized COPP need to be submitted, Firm has
submitted copy of COPP.
Previous decision Registration board in its 254th meeting Deferred for:
 Submission of Legalized COPP.
 Confirmation of availability in reference drug
authorities.
 Confirmation of me-too status.
 Stability studies as per ICH/WHO Zone IV-A
conditions.
Evaluation by PEC Firm Has Submitted Following:
 Legalized Copy Of ―COPP‖ Both In Spanish And With
English Translation (Certificate# 2018005596) Issued By
―National Institute For The Surveillance Of Medications And
Foods‖, Ministry Of Health And Social Protection, Republic
Of Colombia.
 Following Particulars Are Evident Form The Submitted
Copp:
 Free Sale Status In The Exporting Country I.E.,
Colombia: Available
 Market Authorization Holder: ―M/s Productora Y
Comercializadora Odontologica New Stetic S.A.,
Guarine, Antioquia‖
 Product Authorization Number: INVIMA 2012m-
004009 R4
 Manufcaturer: M/s Productora Y Comercializadora
Odontologica New Stetic S.A., Guarine, Antioquia
 GMP status of manufacturer: Compliant
 Issue don: 10-04-2018
 Long term (36 months) & accelerated (06 months) stability
studies data has been submitted for three batches as per Zone-
IV b conditions.
Decision: Deferred for clarification of applied composition, since reference product contains
―Lidocaine hydrochloride ….. 36 mg‖ whereas applied product conatins ―Lidocaine as
hydrochloride…..36mg.‖
391. Name and address of Applicant M/s Medinet Pharmaceuticals ,Building No. 601, First Floor ,
Main Peshawar Road, Near Lane No. 5, Rawalpindi
Detail of Drug Sale License Address: Building No. 601, First Floor , Main Peshawar Road,
Near Lane No. 5, Rawalpindi
Status: License to sell drugs as a distributor
Name and address of manufacturer Biomendi , S. A.U , Poligono Industrial de Bernedo ,s/n, 01118,
Bernedo (Alava), Spain
Name and address of marketing License Holder/MAH
authorization holder G.E.S Genericos Espanoles Laboratorio, S. A.
Colquide 6-Portal 2,1 –Oficina F
28230 Las Rozas Madrid Spain
Product Owner
M/s Altan Pharma Limited , 2 Harbour Square, Crofton Road Dun
Laoghair , Co. Dublin, Ireland
Tha Altan Pharma Limited is the ultimate shareholder of its
affiliate G.E.S Genericos Espanoles Laboratorio and Biomendi ,
S. A.
Name of exporting country Spain

Diary No. & Date of R& I Dy. No. 3465 Dated 26/1/2018
Fee including differential fee Rs. 100,000/- Dated 26/1/2018
Brand Name +Dosage Form + Strength Thrombostat Injection 12.5mg/250mg
Solution for Infusion
Composition One bag of thrombostat contains:
Tirofiban 12.5mg/250ml
Finished Product Specification Inhouse
Pharmacological Group Platelet aggregation inhibitors excl. heparin
ATC Code: B01AC17
Shelf life 2 years
Demanded Price & Pack size Rs 18,934.75; Bag of PVC free polyolefin
International availability Spain: tirofiban TIROFIBAN GES 50 micrograms / ml solution
for perfusion EFG
Me-too status ---
Detail of certificates attached Legalized Scanned Copy CoPP
Certifying Authority: Agencia Espanola Del Medicamento Y
Productos Sanitarios (Spanish Medicines and Health Products
Agency)
Free Sale: Confirms the free sale of the product in exporting
country.
GMP: The facilities and operations conform to WHO-GMP.
Expiry : 1 year
GMP certificate
Certificate No: ES/094HVI/17
Certifying Authority: Agencia Espanola Del Medicamento Y
Productos Sanitarios (Spanish Medicines and Health Products
Agency)
Distribution Agreement
M/s Medinet Pharmaceuticals ,Building No. 601, First Floor ,
Main Peshawar Road, Near Lane No. 5, Rawalpindi
Stability Studies Packaging Material: Nexcel M312
30 Months (2 Batches)
Condition: 30/65%RH
24 Months (1 Batches)
Condition: 30/65%RH
6 Months
Condition:40/<25%RH
Previous Remarks of the Evaluator.  Clarify the difference between product license owner and
product license holder mentioned on Form 5A.
License Holder/MAH
G.E.S Genericos Espanoles Laboratorio, S. A.
Colquide 6-Portal 2,1 –Oficina F
28230 Las Rozas Madrid Spain
Product Owner
Both companies belong to same shareholder Altan Pharma
Limited.
Tha Altan Pharma Limited is the ultimate shareholder of its
affiliate G.E.S Genericos Espanoles Laboratorios and Biomendi ,
S. A.
 ―Not require any special storage condition‖.
 Test for Water loss has been determined i.e. test for semi-
permeable membrane.
Shortcomings
 Name of drug in COPP is TIROFIBAN GES 50
micrograms / ml solution for perfusion EFG.
 Valid drug sale license is missing Provide notary attested
photocopy.
Applied for Renewal, not yet received.
Previous Decision: Registration Board in its 285th meeting Deferred for the following reasons:
 Clarification regarding the difference in brand name mentioned on COPP i.e. ―TIROFIBAN GES 50
micrograms / ml solution for perfusion EFG‖ and on Form
 5A i.e. ―Thrombostat Injection 12.5mg/250mg Solution for Infusion‖.
 Submission of valid drug sale license.
 Justification for submission of stability data at 30 °C ± 2 °C/65% RH ± 5% RH as the requirement
for aqueous-based products packaged in semi-permeable containers is at 30 °C ± 2 °C/35% RH.
Evaluation by PEC:
The firm has submitted as under:
 The brand name in Spain is as mentioned on COPP that is ―Tirofiban GES 50micrograms/ml solution
for perfusion EFG‖ but we are proposing the brand name ―Thrombostat Injection‖ for Pakistan. Both the
products are same only the brand name is different in Pakistan.
 We have been authorized by the principal for this brand name (copy of communication via e-mail
enclosed) and we have received from the Trade marks registry, Karachi, the certificate of Registration of
trade mark section 33 (4) for ―Thrombostat‖ dated, 04 Oct. 2018 (copy enclosed).
 Copy of valid DSL for M/s Medinet Pharmaceuticals, Building No. 601, Lane No. 5, Main Peshawar
Road, District Rawalpindi, valid upto 13-12-2019.
 Firm has submitted stability studies data for three batches at 30 °C ± 2 °C/35% ± 5% RH.
abroad.
392. Name and address of Applicant M/s Servier Research and Pharmaceuticals [Pakistan](pvt). Ltd,
Country Head Office: 65- Main Boulevard, Gulberg, Lahore,
Pakistan.
Detail of Drug Sale License Valid upto: 28-06-2020
Name and address of manufacturer M/s Servier (Ireland) Industries ltd., Gorey Road, Arklow Co
Wicklow, Ireland.
Name and address of marketing M/s Les laboratories Servier, 50 rue Carnot, 92284, Suresnes
authorization holder Cedex, France.
Name of exporting country Ireland
Diary No. & Date of R& I Dy No. 12544: 05-4-2018
Fee including differential fee PKR 50,000/-: 05-04-2018
Brand Name +Dosage Form + Strength COVERSAM 5/10 tablet
Perindopril Arginine …………………5mg
Amlodipine besylate eq. to Amlodipine…………. 10mg
Finished Product Specification Innovator‘s Specs.
Pharmacological Group Anti- Hypertensive
Shelf life 03-Years (demanded)
Pack size 30‘s
International availability Perindopril/Amlodipine. 5mg/10mg. Tablets IC0041-013-002.
Approved in HPRA, Ireland.
Me-too status NA.
Detail of certificates attached  Original and Legalized Certificate of Pharmaceutical Product
(COPP).
 Sole Agency agreement (Expired).

 Copy of Valid Drug Sale License.
 Credentials of the manufacturer.
 GMP inspection report of the manufacturer conducted on 31 st
March 2017 wherein stated that the firm comply with the
requirements of the EU Guide to GMP.
 Copy of Sole Agency agreement submitted notarized from Lahore, wherein it is stated that,
―This agreement shall thereafter remain en-forced until September 30, 2016. It shall thereafter be
automatically renewed for subsequent one (1) year period.‖
 Undertaking that the applied brand name is not similar or has no resemblance (look alike- sound
alike) with already registered drugs to justify the fee submitted.
Previous Decision: Registration Board in its286th meeting deferred for submission of original, valid and
legalized sole agency agreement.
Evaluation by PEC: Firm has submitted notarized copy of ―Purchase and Supply Agreement‖ signed on 1 st
November 2018, between M/s Les laboratories Servier, 50 rue Carnot, 92284, Suresnes Cedex, France and
M/s Servier Research and Pharmaceuticals Pakistan (pvt). Ltd, 65- Main Boulevard, Gulberg, Lahore,
Pakistan.
abroad.
Pakistan.
Wicklow, Ireland.
Perindopril Arginine ……………………….…10mg
Amlodipine besylate eq. to Amlodipine…………...10mg
Pack size 30‘s
Me-too status NA.
(COPP).

Pakistan.
abroad.
Pakistan.
Wicklow, Ireland.
Brand Name+Dosage Form+Strength COVERSAM 5/5 tablet
Perindopril Arginine ………………………………5mg
Amlodipine besylate eq. to Amlodipine…………. .5mg
Pack size 30‘s
Me-too status NA.
(COPP).
M/s Servier Research and Pharmaceuticals Pakistan (pvt). Ltd, 65- Main Boulevard, Gulberg, Lahore.
abroad.

Pakistan.
Wicklow, Ireland.
Perindopril Arginine ………………………………10mg
Amlodipine besylate eq. to Amlodipine…………. …5mg
Pack size 30‘s
Me-too status NA.
(COPP).
Pakistan.
abroad.

Case No. 06 Registration Applications of Drugs for which Stability Study Sata is
Submitted.
a. Deferred Cases.
396. Name and address of manufacturer / M/s Sami Pharmaceuticals Pvt. Ltd, Karachi.
Applicant
Brand Name+Dosage Form+ Strength Iburo Injection 800mg/8ml
Ibuprofen…800mg
Diary No. Date of R& I & fee Dy. No. 31027; 14-09-2018; Rs. 50,000/-, 14-09-2018
Type of Form Form-5D
Finished product Specifications Innovator specifications
Pack size & Demanded Price Rs. 13,500/vial Rs. 13,5000/10‘s vial
Approval status of product in Approved in USFDA
Reference Regulatory Authorities Caldolor by Cumberlands Pharmaceuticals
Me-too status (with strength and N/A
dosage form)
GMP status Last GMP Inspection dated 3-10-2017 with conclusive remarks of
good level of GMP compliance.
STABILITY STUDY DATA
Drug Iburo Injection 800mg/8ml
Name of Manufacturer M/s Sami Pharmaceuticals Pvt. Ltd
Manufacturer of API SI Group ,Orangeburg, SC, USA
API Lot No. 4050-3159
Description of Pack
Glass Vial
(Container closure system)
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months
Accelerated:06Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,1,2,3,4,6 Months
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 10.5 liter 10.5 liter 10.5 liter
(1333 vials) (1333 vials) (1333 vials)
Manufacturing Date Dec 2017 Dec 2017 Dec 2017
Date of Initiation Jan 2018 Jan 2018 Jan 2018
No. of Batches 03
Date of Submission Dy. No. 31027; 14-09-2018
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
No.
1. COA of API Yes
Lot number: 4050-3159
2. Approval of API by regulatory authority of SI Group, Inc. ,725 Cannon Bridge Road, Orangeburg,
country of origin or GMP certificate of API South Carolina (SC) 29115, United States (USA)
manufacturer issued by regulatory authority of 12/31/2019
country of origin.

3. Protocols followed for conduction of stability Yes
study and details of tests.
4. Data of 03 batches will be supported by Yes
attested respective documents like
chromatograms, laboratory reports, data sheets
etc.
5. Documents confirming import of API etc. Yes
Invoice No:442831
Ibuprofen 40 Microns
ADC Attested Invoice dated: 09-10-2017
Quantity: 5 Kg
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of Yes
data / documents.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR
● The firm has claimed In House specifications and the product is not present in USP/BP.
Sr. No. Deficiencies/Shortcomings Reply by Firm

Justify the quantity of API i.e. Quantity of API has been calculated on the basis of its
1. 805.713/vial used in the formulation as potency and considering the assay value, moisture content
the label claim is 800mg/vial. etc.,
We attached herewith FORM 7 marked as Annexure 02,
which in essence is batch declaration obtained from the
Batch No of API not mentioned on
2. Manufacturer on its letter head as per Drug Act, 1976.
ADC invoice and Form 6.
FORM 6 and endorsement from ADC was applied against
FORMs 3 and 7.
Approval of API by regulatory
SI Group, Inc., 725 Cannon Bridge Road, Orangeburg,
authority of country of origin or valid
South Carolina (SC) 29115, United States (USA)
3. GMP certificate of API manufacturer
Registration of Establishment No. 3011012288
issued by regulatory authority of
Validity: 12/31/2019
country of origin.
Batch size of the lab scale batches are 10.5 liters, vials
produced from 10.5 liters are 1312 vials approx.
Clarify how 10.5 L batch size is
903 vials sent for stability, remaining vials utilized in initial
4. equivalent to 1333 vials?
test analysis
Due to typographical error in analytical reports; no. of vials
1333 was mistakenly written instead of 903 vials- Sorry
• Method of analysis of assay has gradient program of
75 minutes
• Complete analysis at single frequency of stability at
The batch no Lab-01 the standard 3 was
3rd and 6th month consist of at least 15 runs
ran on 7 July 2018 at 6:09 pm and
• At 6th month time point, in analysis of Ibuprofen
5. sample on 8 July 2018 at 2:34 am.
sequence of injections started on Saturday, July 07, 2018 at
Justify the time gap between standard
3:38:01 PM
and sample. (Accelerated Condition).
• Ended on Sunday, July 08, 2018 at 10:34:28 AM
that is also verified by our attached audit trail marked as
Annexure 06
The batch no Lab-01 the standard 3 was • Method of analysis of assay has gradient program of
ran on 3 April 2018 at 6:09 pm and 75 minutes
6.
sample on 4 April 2018 at 3:00 am. • Complete analysis at single frequency of stability at
Justify the time gap between standard 3rd and 6th month consist of at least 15 runs
and sample. (Real time Condition). • Similarly, at 3rd month time point, sequence of
injections started on Tuesday, April 03, 2018 at 3:37:22 PM
and
• Ended on Wednesday, April 04, 2018 at 09:20:01
AM that is also verified by our attached audit trail marked as
Annexure 07
The batch no Lab-2 an intense peak has
been observed in both standards and Due to system behavior, extra peak appears on both standard
7. samples at RT between 50 min and and samples that means this peak is due to system response,
60minutes, especially in standard not due to degradation
.Justify. (Accelerated Condition).
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Iburo (Ibuprofen)
800mg/8ml Injection by M/s Sami Pharmaceuticals Pvt. Limited, Karachi.
Reference No: F.13-11/2017-PEC (Pt) dated 23rd January, 2019.
Investigation Date and Time: 28th January, 2019. (Forenoon)
Investigation Site: Factory premises of M/s Sami Pharmaceuticals Pvt. Ltd. Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Sami Pharmaceuticals (Pvt.) Ltd., Karachi
for registration of Iburo (Ibuprofen) 800mg/8ml Injectionand constituted a three member panel to investigate the
authenticity / genuineness of data (import of raw material and stability data). Panel was advised to conduct
inspection of the firm and to submit report for further consideration.
1. An intense peak was observed for batch no. Lab-02 in both standard and sample at Retention time between
50min and 60mins. The firm provided the following justification that ―Due to system behaviour extra peak
appears on both standard and samples shall mean this peak is due to system response, not due to degradation‖.
Composition of Panel:
1. Dr. Rafeeq Alam, Meritorious Professor, Department of Pharmacology, University of Karachi, Karachi,
Member Registration Board.
2. Mr. Aslam Shah, Member Registration Board.
3. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also audited.
The details of investigation may be summarized as under:
Details of Investigation:
S.No. Description Observation by panel
The firm has imported 5.0kg Ibuprofen raw material from M/s
Do you have documents confirming SI Group Inc, United States, vide invoice no. 442831 dated 05-
1 the import of API including approval 09-2017 and has obtained approval from DRAP Karachi.
from DRAP? Batch No. Quantity Imported
4050-3159 5.0kg
There is proper vendor evaluation process being implemented
by the firm and the rationale behind vendor selection is
Do you have any rationale behind
2 controlled through:
selecting the particular manufacturer
 Postal Audit checklist
 GMP approval by competent authority
Do you have documents confirming The firm has imported EP grade 250mg of reference standard
3 the Import of Reference standard and and impurity standard from EDQM
Impurities standards?

4 The firm has Certificate of Analysis for API, working standards
Do you have certificate of analysis of
and impurity standard.
the API reference standard and
impurities standards?
Do you have any approval of API or The API manufacturer is registered establishment by USFDA
GMP certificate of manufacturer the USFDA identifier is 3011012288 which is valid till 31-
5
issued by regulatory authority of Dec-2019. The firm has also provided copy of GMP certificate
country of origin? issued by TGA Australia.
Do you use API manufacturer method The firm has used pharmacopoeial method of testing.
6
of Testing for testing of API?
Do you have stability Studies Report The firm has stability studies report of API Ibuprofen
7
on API? conducted by API manufacturer.
If Yes, whether the stability testing has The manufacturer of API has performed the stability studies of
been performed as per SIM method API as per SIM Method.
8
and degradation products have been
quantified?
Do you have method for quantifying The firm has methods for quantifying the impurities in API.
9
the impurities in the API?
Do you have some remaining The firm has 3.20Kg API Ibuprofen but have consumed all
10 quantities of the API, Its reference reference standard and impurity standard.
standard and impurities standard?
Have you used pharmaceutical grade The firm has used pharmaceutical grade excipient L-arginine.
11
excipients?
Do you have documents confirming The firm has documents confirming the import of the used
12 excipients.
the import of the used excipients
Do you have test reports and other The firm has test reports and other records on the excipients.
13
records on the excipients?
Do you have written and authorized The firm has written and authorized protocol for the
14 protocols for the development of Iburo development of Iburo 800mg/8ml Injection.
800mg/8ml Injection?
Have you performed Drug-Excipient Since firm has used same excipients as used by the innovator.
15 compatibility studies? Therefore, compatibility studies were not performed.
Have you performed comparative The firm has performed comparative studies on the basis of
16
studies? physical, chemical and microbiological analysis.
The firm has product development (R&D) Section with the
facility of manufacturing oral and topical preparation only. The
Do you have Product Development /
product under consideration has been manufactured in routine
17 R&D Section?
sterile area of the firm. The firm has dedicated analytical
section for development of analytical methods and testing of
new products.
Do you have necessary equipment‘s The firm has necessary equipment available in routine sterile
available in product development area for development ofIburo Injection 800mg/8ml.
18
section for development of Iburo
800mg/8ml Injection?
Are the equipment‘s in product The available equipment in Product Development and sterile
19 area are qualified.
development qualified?
Do you have proper maintenance / There is proper maintenance / calibration program for the
20 calibration / re-qualification program equipment used in PD.
for the equipment used in PD?

Do you have qualified staff in product The firm has 08 Pharmacists and 02 Chemists for Product
development section with proper Development Formulation and 6 Pharmacist and 4 Chemists in
21
knowledge and training in product Analytical side.
development?
Have you manufactured three stability The firm has manufactured three stability batches of each
batches for the stability studies of 10.5L.
Iburo 800mg/8ml Injection as Iburo 800mg/8ml Injection
required? Batch No Date of Mfg. Expiry Date
22
Lab-01 12-17 11-19
Lab-02 12-17 11-19
Lab-03 12-17 11-19
Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is the
23 number of Injection per testing frequencies.
batch size of stability of batches?
Do you have complete record of The firm has complete record for the stability batches of Iburo
24
production of stability batches? 800mg/8ml Injection.
Do you have protocols for stability The firm has protocols for testing of stability batches.
25
testing of stability batches
Do you have developed and validated The firm has developed and validated method of testing of
26 the method for testing of stability finish product Iburo 800mg/8ml Injection, based on method of
batches testing of API.
Do you have method transfer studies Method transfer studies is not applicable as the firm developed
in case when the method of testing and validated their own method.
27
being used by your firm is by any
other lab.
Do you have documents confirming The firm has proper documents confirming the qualification of
the qualification of equipment / equipment / instruments being used in the test and analysis of
28 instruments being used in the test and the Iburo 800mg/8ml Injection.
analysis of the product‘s API and
product Iburo 800mg/8ml Injection?
Do your method of analysis Stability The firm‘s Method of analysis is Stability indicating.
29
indicating?
Do your HPLC software 21CFR The HPLC software is 21CFR compliant.
30
compliant?
Can you show audit trail reports on The firm has audit trail Reports on testing.
31
Iburo 800mg/8ml Injection testing?
Do you have some remaining The firm has some remaining quantities of stability batches
32 quantities of degradation products and only.
stability batches?
The firm has three stability batches kept on stability for Real
Do you have batches kept on stability
33 time stability testing. 9 Months Real Time and 6 months
testing?
Accelerated stability studies has been completed.
Do you have valid calibration status The firm has valid calibration status for the equipment used in
for the equipment‘s used in Iburo Iburo 800mg/8ml Injection production and analysis.
34
800mg/8ml Injection production and
analysis?
Do Proper and Continuous monitoring Adequate monitoring and control are available for stability
35 and control are available for stability chamber. Chambers are controlled and monitored through
chamber? software 21CFR compliance.
Do related manufacturing area, Related manufacturing area, equipment, personnel and utilities
36 equipment, personnel and utilities be can be rated as GMP compliant.
rated as GMP compliant?

Any other query raised by the
Pharmaceutical Evaluation Cell? 1. The panel observed a peak of similar nature in
An intense peak was observed for mobile phase run at same retention time, this
batch no. Lab-02 in both standard and type of peak is also observed in other runs
sample at Retention time between too. However, the peak area is very less as
37 50min and 60mins. The firm provided compared to the mentioned peak.
the following justification that ―Due to 2. The panel disagrees with the firm‘s response
system behaviour extra peak appears and conclude the peak to be of mobile phase.
on both standard and samples shall
mean this peak is due to system
response, not due to degradation‖.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Iburo 800mg/8ml Injection (Ibuprofen) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are compliant and are suited for the
manufacturing of Iburo 800mg/8ml Injection.
Decision of 288th meeting:Registration Board after thorough deliberation deferred the case for submission of
documented analytical evidence wherein it has been identified that an intense peak observed in both standard and
sample at retention time between 50min and 60mins is of mobile phase.
Remarks of Evaluator:
Firm has submitted as under:

 To investigate the issue of extra peak eluted in analysis of IBURO 800mg/8ml Injection at 56 th minute, few
exercises have been performed to prove that the particular unknown peak at 56 minute was not linked with
any impurity, degradation or related substance
 To further support our claim that the said unknown peak is due to chromatographic condition gradient
system generated, we have performed following exercises:
EXERCISE # 1:
 Analysis with extended run time of 100 minutes instead of 75 minutes inject the mobile phase, standard,
sample and impurity standards to see whether any impurity eluted after the normal run time.
OBSERVATION:
 No peak of API and any impurity related to API were eluted after normal stop time i.e. 75 minutes.
 The approx. relative retention time of ibuprofen and its impurities (as listed below) and none of these
impurities were observed at 56th minute.
 Kindly note a peak is eluted at 56th minute when we have a change in ratio of mobile phase in gradient
programme at 55th minute.
TIME MOBILEPHASE A MOBILE PHASE B
25 100 0
55 15 85
70 15 85
CONCLUSION:
 None of these impurities were eluted or gave peak at 56th minute. Hence, it is due to system generated jerk
because of significant change in gradient program.
 Reference chromatograms of mobile phase, standard, sample and impurity standards are attached and
marked as annexure 1.
EXERCISE # 2:
 To Identify that any API impurity is eluting at 56 minutes the fraction discharge of sample and standard at
run time 55 minute ± 10 minutes are collected and inject on same HPLC system
OBSERVATION:
 During whole run time, no peak of API and its related impurity is observed only the same peak was
observed at same retention time which was due to significant change in gradient programme

CONCLUSION:
 It was concluded that the fraction discharge which was collected and run on HPLC shows no peak of
impurity, API and related compound
 However, the same response were observed which as mentioned above was due to significant change in
gradient programme
 Please again note a peak is again eluted at 56 th minute when we have a change in ratio of mobile phase in
gradient programme at 55th minutes
 Reference chromatograms of fractional discharge of standard and sample are attached and marked as
annexure- 2
EXERCISE # 3:
 To investigate the behavior of system due to change in gradient program at particular time , we have
changed the ratio of mobile phase at 60 minutes instead of 55 minutes and again injected mobile phase,
standard , sample and impurity standard
OBSERVATION:
 It was observed that after changing gradient program, the peak which was observed at 56 minutes shifted to
61 minutes
CONCLUSION:
 After this study we have concluded that the said peak is purely system generated jerk because of significant
change in mobile phase ratio
 Reference chromatograms are attached and marked as annexure - 3
Firm has also submitted relevant chromatograms for the above cited studies.
Decision: Registration Board decided to approve registration of ―Iburo (Ibuprofen) 800mg/8ml Injection by
M/s Sami Pharmaceuticals Pvt. Limited, Karachi. Manufacturer will place first three production batches of
the product on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.
b. Verification of stability study data

Sr. Name & Address of Brand Name Type of Form, International Availability /
No. Manufacturer / (Proprietary Name + Initial Diary & Local Availability
Applicant Dosage Form + Date, Fee (including
Strength), Composition, differential fee), GMP Inspection Report
Pharmacological Group, Demanded Price / Date & Remarks
Finished Product Pack size
Specification
397. M/s Macter Sacval tablet Form 5D USFDA approved
International Ltd, F- Each film coated tablet Dy. No. 3920, Last GMP inspection report
126, SITE, Karachi. contains: 24-05-2017 date 14-03-2017 concluding
Sacubitril…….49mg PKR 50,000/-: 24- good level of GMP
Valsartan ….. 51mg 05-2017 compliance.
(Neprilysin inhibitor, & Rs. 600/tablet
Angiotensin receptor
blocker)
Evaluation by PEC:
The firm has submitted stability data along with documents as per checklist approved in 278 th meeting of
Registration Board.
Details of submitted data are as under:
Drug Sacval tablet
Name of Manufacturer M/s Macter International Ltd, F-126, SITE, Karachi.
Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co., Ltd., Jinwan District, Zhuhai City,
Guangdong province, China.
API Lot No. 57317060103
Description of Pack Alu-Alu blister packed in unit carton
th
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0,3 & 6 months
Real Time: 0,3,6 months
Batch No. 001P 002P 003P
Batch Size 1500 tablets 1500 tablets 1500 tablets
Manufacturing Date 01-2018 01-2018 01-2018
Date of Initiation 20-01-2018 20-01-2018 20-01-2018
No. of Batches 03
No.
1. COAS of APIs Yes.
2. Approval of API by regulatory authority of country of GMP certificate (certificate# GD20160649)
origin or GMP certificate of API manufacturer issued issued by China Food And Drug Administration,
by regulatory authority of country of origin. valid upto 13-11-2021, in the name of M/s
Zhuhai Rundu Pharmaceutical Co., Ltd., Jinwan
District, Zhuhai City, Guangdong province,
China.
3. Protocols followed for conduction of stability study
No
and details of tests.
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory Yes
reports, data sheets etc.
5. Documents confirming import of API etc. Copy of Form 6 dated 31-10-2017 has been
submitted for import of Sacubitril & Valsartan
(1:1). Quantity: 2 Kgs.
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Yes
documents.
7. Commitment to continue real time stability study till
Yes
assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules,
Yes
1978.
Specification
Sacubitril…… 24mg PKR 50,000/-: 24- good level of GMP

(Neprilysin inhibitor, & Rs. 600/tablet
blocker)
Evaluation by PEC:
The firm has submitted stability data along with documents as per checklist approved in 278th meeting of
Registration Board.
Drug Sacval tablet
API Lot No. 57317060103
Description of Pack
Alu-Alu blister packed in unit carton
No. of Batches 03
No.
China.
No
documents.

Yes
Yes
1978.
Specification
Sacubitril…….97mg PKR 50,000/-: 24- good level of GMP
(Neprilysin inhibitor, &
blocker)
Evaluation by PEC:
Registration Board.
Drug Sacval tablet
API Lot No. 57317060103
Description of Pack
No. of Batches 03
No.

China.
No
documents.
Yes
Yes
1978.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Sacval
24mg+26mg, 49mg+51mg, 97mg+103mg (Sacubitril - Valsartan) Tablets by M/s. Macter International
Ltd., F-216, S.I.T.E, Karachi.
Reference No: F.13-11/2017-PEC (Vol. I) dated 06th March, 2019.
Investigation Date and Time: 23th April, 2019 (Afternoon).
Investigation Site: M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Macter International Ltd., F-216,
S.I.T.E, Karachi for registration of Sacval (Sacubitril - Valsartan) 24mg+26mg, 49mg+51mg, 97mg+103mg
Tablets. PER Division considered scientifically rational laboratory scale data submitted by the firm as pre-
requisite of registration being new formulation and constituted a three-member panel to investigate the
authenticity / genuineness of data (import of raw material and stability data). Panel was advised to conduct
1. Dr. Rafeeq Alam Khan, Meritorious Professor and Dean, Faculty of Pharmacy, Ziauddin University.
(Member Registration Board)
2. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
3. Dr. Krishan Das, Assistant Director, DRAP, Karachi.

involved, ongoing studies, printed data and integrity and security of data in respective databases were also
audited. The details of investigation may be summarized as under:
Detail of Investigation:
S. No. Question Observation

1. Do you have documents confirming the The firm has imported 2Kg Sacubitril - Valsartan (Co-
import of Sacubitril - Valsartan API crystal) API from M/s. Zhuhai Rundu Pharmaceutical Co.
including approval from DRAP? Ltd vide invoice No. RIS17087 dated: 10.10.2017. There is
proper approval from DRAP Karachi on Form 6 (2966-17)
2. What was the rationale behind selecting The rationale behind selecting the particular manufacturer of
the particular manufacturer of API? API is the vendor evaluation process based on audit and
other criteria like manufacturer GMP status, DMF source
etc.
3. Do you have documents confirming the The firm has imported Sacubitril - Valsartan working
import of Sacubitril - Valsartan standard and two impurity standards from the API
reference standard and impurity manufacturer.
standards?
4. Do you have certificate of Analysis of The firm has Certificate of Analysis of API, working
the API, reference standards and standard of API and impurities standards.
impurity standards?
5. Do you have GMP certificate of API The firm has GMP certificates for API manufacturer issued
manufacturer issued by regulatory by Zhuhai Food & Drug administration, China.
authority of country of origin?
6. Do you use API manufacturer method The firm has used API manufacturer method of testing.
of testing for testing API?
7. Do you have stability studies reports on The firm has stability studies report on API (Sacubitril -
APIs? Valsartan ) conducted by API manufacturer.
8. If yes, whether the stability testing has The manufacturer of API has performed the stability studies
been performed as per SIM method and as per SIM method. The process related impurities have
degradation products have been been quantified, however, no degradation product has been
quantified? observed.
9. Do you have method for quantifying The firm has method for quantifying impurities.
the impurities in the API?
10. Do you have some remaining quantities The firm has some remaining quantities of API (Sacubitril -
of the API, its reference standard and Valsartan ) working standard and impurity standard.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? including Microcrystalline cellulose, Hydroxypropyl
cellulose, Crospovidone, Magnesium stearate, Talcum
Powder & Colloidal Silicon dioxide.
12. Do you have documents confirming the The firm has necessary documents confirming the import of
import of the used excipients? the used excipients.
13. Do you have test reports and other The firm has test reports and other records for the excipients
records on the excipients used? used.
14. Do you have written and authorized The firm has written and authorized protocol for the
protocols for the development of development of Sacval (Sacubitril - Valsartan )24mg+26mg,
Sacubitril - Valsartan Tablets? 49mg+51mg, 97mg+103mg tablets.
15. Have you performed Drug-excipient The firm has not performed Drug Excipient compatibility
compatibility studies? studies as composition of their product is similar to that of
innovator product (Entresto Tablets, from Novartis, UK.
16. Have you performed comparative The firm has perform comparative dissolution profile with
dissolution studies? innovator product. The firm‘s product shows comparable
dissolution profile.
17. Do you have product development The firm has product development (R&D) section with
(R&D) section requisite facilities.

18. Do you have necessary equipments The firm has all the necessary equipment available in
available in product development product development section for the development of
section for development Sacubitril - Sacubitril - Valsartan tablets.
Valsartan Tablets?
19. Are the equipment in product The equipment in product development section are
development section qualified? qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-
calibration / re-qualification program qualification program for the equipment used in PD section.
for the equipment used in PD section?
21. Do you have qualified staff in product The firm has qualified staff in PD section with proper
development section with proper knowledge and training in Product Development including
knowledge and training in product 01 Ph.D., 04 Pharmacists 04 MSc Chemistry and 01 BEMS
development? & M.Phil.
22. Have you manufactured three stability The firm has manufactured three stability batches as
batches for the stability studies of follows;
Sacubitril - Valsartan Tablets Sacubitril - Valsartan 24mg +26mgtablets:
required? Sr. No. B. No. Batch size
1 001P 1500
2 002P 1500
3 003P 1500
Sacubitril - Valsartan 49mg+51mg tablets:
Sr. No. B. No. Batch size
1 001P 1500
2 002P 1500
3 003P 1500
Sacubitril - Valsartan 97mg+103mg tablets:
Sr. No. B. No. Batch size
1 001P 1500
2 002P 1500
3 003P 1500
The tablets are packed in Alu Alu blisters with pack size 14s
for both potencies.
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches is
batch size of stability batches? the number of tablets required per testing frequency and
number of testing frequencies.
24. Do you have complete record of The firm has complete records of production of stability
production of stability batches? batches.
25. Do you have protocols for stability The firm has detailed protocol for the stability testing of
testing of stability batches? Sacubitril - Valsartan tablets.
26. Do you have developed and validated The firm has developed and validated method for testing of
the method for testing of stability stability batches of finished product i.e. Sacubitril -
batches? Valsartan tablets based on the API method of testing
provided by the API manufacturer.
27. Do you have method transfer studies in The firm has developed and validated method based on API
case when the method of testing being manufacturer for testing of finished product.
used by your firm is given by any other
lab?

28. Do you have documents confirming the The firm has proper documents confirming the qualification
qualification of equipment / of equipment / instruments being used in the test and
instruments being used in the test and analysis of the API (Sacubitril - Valsartan ) and the finished
analysis of Sacubitril - Valsartan and drug Sacval (Sacubitril - Valsartan ) tablets.
the finished drug?
29. Do your method of analysis stability The firm method of analysis is stability indicating as
indicating? evidence by forced degradation studies and spiking studies
of the two major impurities. Both the impurities are process
related and the forced degradation studies also confirmed
that there is no degradation product.
30. Do your HPLC software 21CFR The HPLC software is 21CFR compliant as per record
Compliant? available with the firm.
31. Can you show Audit trail reports on Audit Trail on the testing reports on Sacubitril - Valsartan
Sacubitril - Valsartan testing? API and Sacval tablets is available.
32. Do you have some remaining quantities The firm has only remaining quantities of stability batches
of degradation products and stability kept on real-time stability testing.
batches?
33. Do you have stability batches kept on The firm has three lab scale batches kept on stability studies
stability testing? for real time stability testing. Currently 12 months studies
have been completed with satisfactory results.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment used
the equipment used in Sacubitril - in Sacval (Sacubitril - Valsartan ) tablets production and
Valsartan Tablets production and analysis.
analysis?
35. Do proper and continuous monitoring The firm has adequate monitoring and control system for
and control are available for stability stability chambers.
chamber?
36. Do related manufacturing area, The related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are GMP compliant at time of inspection.
rated as GMP compliant?
Conclusions:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Sacval 24mg+26mg (Sacubitril - Valsartan ) Tablets , Sacval 49mg+51mg (Sacubitril -
Valsartan ) Tablets, Sacval 97mg+103mg Tablets (Sacubitril - Valsartan ) Tablets is verifiable
satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well suited
for the manufacturing of Sacval 24mg+26mg (Sacubitril - Valsartan ) Tablets, Sacval 49mg+51mg
(Sacubitril - Valsartan ) Tablets , Sacval 97mg+103mg (Sacubitril - Valsartan ) Tablets.
Recommendation
1. Keeping in view above mentioned conclusion registration of Sacval 24mg+26mg, 49mg+51mg,
97mg+103mg tablets is recommended in the name of manufacturer.
Decision: Registration Board decided to approve registration of ―Sacval tablet 24/26
(Sacubitril/valsartan)‖, ―Sacval tablet 49/51 (Sacubitril/valsartan)‖ ―Sacval tablet 97/103
(Sacubitril/valsartan)‖ by M/s Macter International Ltd, F-126, SITE, Karachi.Manufacturer will place
first three production batches of all products on long term stability studies throughout proposed shelf life
and on accelerated studies for six months.
Sr. Name & Address of Brand Name Type of Form, International
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Fee Availability / Local
Applicant Dosage Form + (including differential Availability
Strength), fee),
Composition, Demanded Price / Pack GMP Inspection Report
Pharmacological size Date & Remarks

Group,
Finished Product
Specification
400. M/s Indus Pharma (Pvt.) Canazin tablet 300mg Form-5-D Invokana 300mg film-
Limited, Plots No. 26, Each film-coated tablet coated tablets of M/s
27, 63-67, Sector-27, contains: Diary. No: 17883 Napp Pharmaceuticals,
Korangi Industrial Area, Canagliflozin (as Dated: 15-05-2018 Limited (MHRA
Karachi. Canagliflozin Approved)
Hemihydrate.300mg Rs.50,000/- (15-05-2018)
(Anti-Diabetic) 10‘s ; as per DPC Not applicable
Manufacturers GMP inspection report
conducted on 14-11-
2017, concluding an
acceptable level of GMP
compliance.
Evaluation by PEC:
- Firm has provided 06 months accelerated and 06 months real time stability data for 03 batches.
Drug Canazin tablet 300mg (Canagliflozin)
Name of Manufacturer M/s Indus Pharma (Pvt.) Limited, Plots No. 26, 27, 63-67, Sector-27, Korangi
Industrial Area, Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatec Co. Limited, China.
API Lot No. RD-CLF (hemihydrate)- 201705101
Description of Pack Alu- Alu Blister strip of 2x5 tablets
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5% RH
Real time : 30°C ± 2°C / 65% ± 5% RH
Time Period Accelerated: 06 months
Real time: 06 months
Frequency Accelerated: 0,3,6 months
Real time: 0,3,6 months
Batch No. TR-01-Can 300 Tab P-1/ Can 300mg Tablet P-2/ Can 300mg Tab
Batch Size 2500 Tablets 2500 Tablets 2500 Tablets
No. of Batches 03
Date of Submission 15-05-2018 (Diary No. 17883)
No.
1. CoA of API Yes
2. Approval
0 of API by regulatory authority of country M/s Nantong Chanyoo Pharmatech Co. Limited,
of origin or GMP certificate of API manufacturer China:
issued by regulatory authority of country of origin.  Photocopy of GMP Certificate issued by
People‘s Republic of China, Nantong,
Jiangsu is submitted.
 Photocopy of Certificate of GMP compliance
of a manufacturer by Agency for medicinal
products and medical devices of the Republic
of Solvenia is submitted.
3. Protocols followed for conduction of stability study Yes

4. Data of 03 batches will be supported by attested Yes
respective documents like chromatograms,
laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Photocopy of ADC (Karachi) attested Commercial
Invoice is submitted.
Commercial invoice is from M/s Changzhou
Pharmaceutical Factory, No. 518 Loading East Road,
Changzhou, China.
6. All provided documents will be attested (name, Yes
sign and stamp) for ensuring authenticity of data /
documents.
7. Commitment to continue real time stability study Yes
till assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules, Yes
1978.
Sr.# Deficiency/ Observation Response by M/s Indus Pharma

i. Initial analysis of finished Raw data sheets of initial analysis showing relevant calculations still need
dosage form is not to be submitted.
submitted.
ii. Justify the time gap The main reason for time gap between withdrawal and analysis of stability
between withdrawal of samples of Canazin tablets is to reduce workload of analysis to club all
sample and its analysis. three batches (i.e. B. No. Tr-1-Can 300 tab, P-1-Can 300 tab and P-2 Can
300 tab) including accelerated and long term-analysis. Canazin tablets B.
No. Tr-1-Can 300 tab was withdrawn at 12-03-2018 while P-1 Can 300 tab
and P-2-Can 300 tab at 20-03-2018 from stability chamber for 6 month
analysis. Analysis was started at 20-03-2018 and was done at 02-04-2018.
iii. Provide system generated Reply needs to be submitted.
(U-V 1800) Absorbance
Values of all time points.
FOR PANEL:
 Verify Dissolution Testing of all Time Points on U-V 1800.
 The Assay Results in Stability Data Sheets of Initial Testing do not match with the Summary Report of the
First Batch i.e. Batch No. Tr-1-Can 300 Tab.
 In the submitted reply, for the first batch i.e. Batch No. TR-01-Can 300mg Tab, Dissolution is 92.96% while
in the stability sheet, it is mentioned as 93.19%.
 The percentage of assay in the submitted reply of initial analysis is 100.43% while in the stability sheet, it is
mentioned as 100.06%.
 Raw data sheets of initial analysis showing relevant calculations still need to be submitted.
 Regarding justification of the time gap between withdrawal of sample and its analysis, firm had replied that
analysis was started at 20-03-2018 and was done at 02-04-2018.While in the submitted raw data sheets of
Canazin tablets Batch No. Tr-1-Can 300 Tab ; withdrawal Date is mentioned as 11-03-18 and Analysis Date
is mentioned as 02-04-2018. Justification / Clarification is needed.
401. Name and address of manufacturer / M/s Indus Pharma (Pvt.) Ltd. Plot No. 26, 27, 63, 64, 65, 66 &
Applicant 67, Sector 27, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Canazin Film Coated Tablets 100mg
Diary No. Date of R& I & fee Dy No. 11346, Rs: 50,000/- 28-03-2018

Composition Each film coated tablet contains:-
Canagliflozin as hemihydrate ….100mg
Pharmacological Group Sodium-glucose co-transporter 2 (SGLT2) inhibitors
ATC Code: A10BK02
Anti-diabetic
Type of Form Form 5-D
Finished Product Specification Manufacturer Specs.
Pack size & Demanded Price Pack of 10‘s
Approval status of product in Invokana tablet-USFDA approved
Me-too status Not applicable
GMP status Last inspection report 16-8-2017 firm was considered to be
operating at an acceptable level of compliance with GMP.
Remarks of the Evaluator.  Method is as per USFDA.

Drug Canazin Film Coated Tablets 100mg
M/s Indus Pharma (Pvt.) Ltd.
Name of Manufacturer Plot No. 26, 27, 63, 64, 65, 66 & 67, Sector 27
Korangi Industrial Area, Karachi
Manufacturer of API M/s NANTONG Chanyoo Pharmatech Co., Ltd, China
API Lot No. RD-CLF(hemihydrate)-201705101
Description of Pack
Alu-Alu blister strip packed in unit carton
Real time : 30°C ± 2°C / 65% ± 5%RH
Stability Storage Condition
Real time: 6 months
Time Period
Real time: 0,3,6 (months)
Frequency
Accelerated: 0,3,6 (months)
TR-01-Can P-1 Can 100 tab P-2 Can 100 tab
Batch No.
100 tab
Date of Initiation 08-2019 08-2019 08-2019
No. of Batches 03
Date of Submission 28-03-2018 (Dy No. 11346)
Sr. No. Documents To Be Provided Status
1. COA of API Yes
RD-CLF (hemihydrate)-
201705101
2. Approval of API by regulatory authority of country of origin or Yes
GMP certificate of API manufacturer issued by regulatory authority
of country of origin.
3. Protocols followed for conduction of stability study and details of Yes
tests.
4. Data of 03 batches will be supported by attested respective Yes
documents like chromatograms, laboratory reports, data sheets etc.

6. All provided documents will be attested (name, sign and stamp) for Yes
ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till assigned shelf Yes
life of the product.
8. Commitment to follow Drug Specification Rules, 1978. Yes
. The firm has claimed In House specifications and the product is not present in USP/BP .
i. Approved in USFDA with box warning.
Shortcoming Reply
Commercial invoice issuer Changzhou Pharmaceutical Factory (3.2kg) is Firm submitted relationship
mentioned. Whereas GMP is of M/s NANTONG Chanyoo Pharmatech Co., letter.
Ltd, China.
The stability data of initial time point shows following discrepancies: Firm has submitted that the
 Batch no. TR-01—Can 100 mg, the COA mentions assay 107.00% identified difference is due to
however, in stability data sheet is 107.03%. typographical error and has
 Batch no. TR-01—Can 100 mg, the COA mentions Dissolution results as revised all stability data sheets.
101.70% however, in stability data sheet is 102.77%.
 Batch no. P-1—Can 100 mg, the COA mentions Dissolution results as
 Batch no. P-2—Can 100 mg, the COA mentions Dissolution results as
Clarify and justify the same.
Remarks of the Evaluators:
The following observations were noted in the stability files as mentioned against each.
Sr. Name of Applicant Brand Name, Composition Observations
No.
1. M/s Indus Pharma Canazin tablet 300mg  Confirmation of performance of Dissolution
(Pvt.) Limited, Plots Each film-coated tablet Testing on UV 1800 as UV spectra and
No. 26, 27, 63-67, contains: system generated results have not been
Sector-27, Korangi Canagliflozin (as provided by the firm.
Industrial Area, Canagliflozin  Confirmation of performance of assay and
Karachi. Hemihydrate)……...300mg dissolution at initial time point as the assay
results mentioned in Stability Data Sheets of
Initial Testing do not match with the COA of
Batch No. Tr-1-Can 300 Tab.
Batch No Stability COA
TR-01-Can Summary
300mg report
Assay 100.06% 100.43%
Dissolution 93.19% 92.96%
 Confirmation and justification regarding the
time gap of 22 days between withdrawal of
sample from stability chamber and its analysis
for Batch No. Tr-1-Can 300 Tab.
Sample withdrawal Date :11-03-18
Analysis Date: 02-04-2018.
2. M/s Indus Pharma Canazin tablet 100mg Confirmation of performance of assay and
(Pvt.) Limited, Plots Each film-coated tablet dissolution at initial time point as the assay results
No. 26, 27, 63-67, contains: mentioned in Stability Data Sheets of Initial
Sector-27, Korangi Canagliflozin (as Testing do not match with the COA.
Industrial Area, Canagliflozin Tests Stability Summary COA
Karachi. Hemihydrate)……...100mg report

TR-01—Can 100 mg
Assay 107.03%. 107.00%
Dissolution 102.77%. 101.70%
P-1—Can 100 mg
Dissolution 100.76%. 99.72%
P-2—Can 100 mg
Firm has submitted that the identified difference
is due to typographical error and has revised all
stability data sheets which needs to be confirmed.
Now, the firm has also claimed exemption. However, as per last product specific inspection report of Sacutan
97mg/103mg ―The HPLC Software is 21 CFR complaint as per record available with the firm. However,
practically implementation of 21 CFR part-11 compliance needs further improvement.by the firm.‖
Therefore on the directions of Chairman Registration Board letter was issued to M/s Indus Pharma, Karachi
regarding improvements made so far by the firm for practical improvement of 21 CFR II compliance of HPLC
software as pointed out in last PSI inspection report. The firm has replied that the following points already exist.
1. The HPLC software is 21 CFR part 11 complaint where all user level are properly defined.
2. No user or main user can delete, edit or manipulate data from software.
3. All actions are recorded in audit trails.
4. Created strict policies on windows and disable options like ―Delete, Copy, Paste and rename‖ of any file
from user level.
Furthermore, the following improvement are being made in order to strengthen it further.
1. A new HPLC of ―Agilent Infinity series‖ has been installed in Quality Control Laboratory & two more
are under procurement and will be commissioned by the mid of 2019.
2. Chromatography Data System (CDS) Software is also being procured for compliance and Data Security.
With the ever-evolving emphasis on data security, data integrity, and compliance, it is of vital importance
that the software provides comprehensive preventive and detection technical controls. This will enable to
meet the latest regulatory requirements and ensure the highest levels of data quality.

Decision of 287th meeting: Registration Board decided to constitute panel for the Canazin 100mg & Canazin
300mg Tablet for onsite investigation to confirm genuineness / authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc., along with following observations.
Brand Name, Composition Observations
Canazin tablet 300mg  Confirmation of performance of Dissolution Testing on UV 1800 as UV
Each film-coated tablet contains: spectra and system generated results have not been provided by the
Canagliflozin (as Canagliflozin firm.
Hemihydrate) ……... 300mg  Confirmation of performance of assay and dissolution at initial time
point as the assay results mentioned in Stability Data Sheets of Initial
Testing do not match with the COA of Batch No. Tr-1-Can 300 Tab.
Batch No Stability Summary COA
TR-01-Can 300mg report
Assay 100.06% 100.43%
Dissolution 93.19% 92.96%
 Confirmation and justification regarding the time gap of 22 days
between withdrawal of sample from stability chamber and its analysis
for Batch No. Tr-1-Can 300 Tab.
Sample withdrawal Date :11-03-18
Analysis Date: 02-04-2018.
Canazin tablet 100mg Confirmation of performance of assay and dissolution at initial time point as
Each film-coated tablet contains: the assay results mentioned in Stability Data Sheets of Initial Testing do not
Canagliflozin (as Canagliflozin match with the COA.
Hemihydrate) ……... 100mg Tests Stability Summary report COA
TR-01—Can 100 mg
Assay 107.03%. 107.00%
Dissolution 102.77%. 101.70%
P-1—Can 100 mg
P-2—Can 100 mg
Firm has submitted that the identified difference is due to typographical
error and has revised all stability data sheets which needs to be confirmed.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Canazin
100mg & 300mg Tablets (Canagliflozin) Tablets by M/s. Indus Pharma (Pvt.) Limited, Korangi Industrial
Area, Karachi.
Reference No: F.13-11/2017-PEC (Vol-I) dated 20th, February, 2019.
Investigation Date and Time: 14th March, 2019 (Morning).
Investigation Site: Factory premises of M/s. Indus Pharma (Pvt.) Limited, Korangi
Background:
Chairman Registration Board considered the applications of M/s. Indus Pharma, Plots No. 26, 27, 63-67,
Sector 27, Korangi Industrial Area, Karachi for registration of Canazin 100mg & 300mg (Canagliflozin)
Tabletsand constituted a three-member panel to investigate the authenticity / genuineness of data (import of raw
material and stability data). Panel was advised to conduct inspection of the firm and to submit report for further
consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology, University of Karachi,
Karachi, Member Registration Board, Islamabad.
2. Dr. Saif ur Rehman Khattak, Director, CDL, DRAP, Karachi.
3. Dr. Sajjad Abbasi, Area FID, DRAP Office, Karachi.


CANAZIN 100MG & 300MG TABLETS
Sr.
Question Observation by Panel
No
1. Do you have documents confirming the import Thefirmhasimported 3.2kgCanagliflozin
o f Canagliflozin API including approval from Hemihydrate fromM/s Nantong Chanyoo, China
DRAP? vide invoice no:CY117185 dated:17/05/2017 with
properapprovalfromDRAP Office,Karachi.
2. What was the rationale behind selecting the There is proper vendor evaluation process being
particular manufacturer of API? implementedincludingPostalAudit checklist,Testing
of API, DMF and GMP approval by competent
authority.
3. Do you have documents confirming the import of The firm has documents confirming the import of
Canaglifloz in reference standard and impurity Canagliflozin Hemihydrate working standard and 05
standard? major impurities standards.
4. Do you have certificate of Analysis of the API, The firm has certificate of analysis of the
reference standard of the API and impurity API,referencestandardoftheAPIand
standard? impuritystandards.
5. Do youhave GMP certificate of API The firm has valid GMP certificate of the API
manufacturers issued by regulatory manufacturer issued by the concerned provincial
authorities of country of origin? RegulatoryAuthorityofthecountryoforigin.
6. Do you use API manufacturer method of testing ThefirmhasusedAPImanufacturermethodfor testing
fortesting API? API.
7. Do you have stability studies report on API? The firmhasstabilitystudies reports on the API.
8. If yes, whether the stability testing has been The stability testing has been performedas perSIM
performed as per SIM method and degradation method.
products have been quantified?
9. Do you have method for quantifying the The firmhasHPLCmethodforquantifying the
impurities in the API? impurities in the API.
10. Do you have some remaining quantities of the The firm has remainingquantitiesof the API, its
API, its reference standard and impurities reference standard and impuritiesstandards.
standards?
11. Have you used pharmaceutical grade excipients? The firm has used pharmaceutical grade excipients
including lactose anhydrous, microcrystalline
cellulose, hydroxy propyl cellulose, croscarmellose
sodium, purified talc, magnesium stearate & opadry
II 85G68918 white (same composition as that of
innovator INVOKANA tablet range).
12. Do you have documents confirming the import of Thefirmhasnecessarydocumentsconfirmingtheimpor
the used excipients? t of the used excipient.
13. Do you have test reports and other records on the The firm has test reports and other records on the
excipients used? excipient used.
14. Do you havewritten and authorized protocols for The firmhas written and authorized protocols for the
the development of Canagliflozin tablets? developmentofCanagliflozin tablets 100mg &
300mg.
15. Have you performed Drug-excipient
compatibility studies?
16. Have you performed comparative Thefirmhasperformedcomparativedissolutionstudies
dissolution studies? on their tablets0 (100mg & 300mg)against
theinnovator product Invokana 100mg tablet
batch no:HBL4Y00 & Invokana 300mg
T ablet Batch No:GKL 9Q000.Thefirm‘s
t a b le t s (100mg & 3 0 0 m g) have
comparabledissolutionprofileswiththatoftheinnovato
r tablets.
17. Doyouhaveproductdevelopment(R&D) section? The firm does not have dedicated product
development section. They have equipments for
manufacturing lab scale batches. Some of these
equipments are used while shifting them to the
commercial manufacturing area; whereas, some
equipments of commercial scale manufacturing are
being used for product development.
Dedicated area for product devlopement is in

process. Design for the same has been finalized.
New equipment is under custom clearance and will
be commissioned after renovation.
18. Do you have necessary equipment available As above.
inproduct development section for development
of Canagliflozin capsules?
19. Are the equipment in product development Theavailableequipmentsforproductdevelopmentsect
section qualified? ion are qualified.
20. Do you have proper maintenance calibration/ Thefirmhaspropermaintenance/calibrationwithre-
re-qualification program for the equipment used qualificationprogramfortheequipmentusedforprodu
in PD section? ct development.
21. Do you have qualified staff in product Thefirmhasateamof05technicalpersons (04
development section with proper knowledge and Pharmacist & 01 M.Sc. Chemistry) for product
training in product development? development. These personnel have proper
knowledge and training in productdevelopment.
22. Have you manufactured three stability batches The firm has manufactured three stability batches of
for the stability studies of Canagliflozin tablets Canagliflozin Tablets.
asrequired? Canagliflozin 100mg tablets having batch No.
TR-01-CAN 100 TAB, P-1 /CAN 100mg TAB, P-
2/CAN 100mg TAB each of 2500tablets. The tablets
are packed in Alu Alu blister pack of 1x.10s
Canagliflozin Tablet 300mg havingbatch#TR-01
CAN 300, P-1CAN 300mg, P-2 CAN
300mgeachof2500 tablet.The tablets are packed in
Alu Alu blisters of pack size 5x2s.
Firm has changed the manufacturing process from
wet granulation (innovator) to direct compression.
23. Do you have any criteria for fixing the batch size The criteria for fixing the batch size of stability
of stability batches? batches is the quantity of tablets required
pertesting frequency and the number of
testingfrequencies.
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches. All the Log Books are properly
maintained.
25. Do you have protocols for stability testing of The firm has detailed protocols for stability testing
stability batches? of stability batches.
26. Do you have developed and validated the method The method is based upon the API method of API
for testing of stability batches? manufacturer which has been validated and used for
the testing finish product in stability testing. The
method is supported by forced degradation studies
on the product hence stability indicating.
27. Do you have method transfer studies in case The firmhasperformed complete validation studies.
when the method of testing being used by your
firm is given by any other lab?
28. Do you have documents confirming the The firm has proper documents confirming
qualification of equipment/instruments being the qualification of equipment/instruments being
used in the test and analysis of Canagliflozin API used in the test and analysis of the API and the
and the finished drug? finished drug.
29. Do yourmethod of analysis stability indicating? The firm has performed forced degradation (FD)
study on their product Canagliflozin Tablet
100mg& Canagliflozin Tablet 300mg for the
conformance of stability indicating nature of their
method for testing the finished product during
stability studies.
30. Do your HPLC software 21CFR 1. Yes HPLC software is 21 CFR Part 11
Compliant? compliant where all user levels are properly
defined.
2. No user or main user can delete, edit or
manipulate data from software.
4. Created strict policies on windows and disable
options like ―Delete, Copy, Paste and rename‖
of any file from user level.
Furthermore, the following improvements are being
made in order to strengthen it further.
1. A new HPLC of ―Agilent Infinity series‖ has
been installed in Quality Control Laboratory &
two more are under procurement and will be
commissioned by the mid of 2019.
2. Chromatography Data System (CDS) Software
is also being procured for Compliance and
Data Security.
With the ever-evolving emphasis on data security,
data integrity, and compliance, it is of vital
importance that the software provides
comprehensive preventive and detection technical
controls. This will enable us to meet the latest
regulatory requirements and ensure the highest
levels of data quality.
31. Can you show Audit trail reports on Audittrailonthetestingreports is available.
Canagliflozintesting?
32. Do you have some remaining quantities of The firm has remaining quantities of stability
degradation products and stability batches? batches only.
33. Do youhave stability batches kept on The firm has three stability batches kept on realtime
stabilitytesting? stability testing. 12months studies have been
completed on the sebatches with satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the
equipment‘s used in Canagliflozin capsules equipment used in Canagliflozin 300mg tablet
production andanalysis? production and analysis.
35. Do proper and continuous monitoring and control Adequate monitoring and control are available for
are available for stability chamber? stability chambers including data loggers and
centralized controlling software.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel
equipment, personnel and utilitiesberated as and utilities are in compliance.
GMP compliant?
37. Observations of PEC? 1. The resubmitted data is correct and has been
Assay and observation results initially provided to verified from system and concerned log
PEC were wrong. books.

Correct data was resubmitted to the PEC.
All revised stability data sheets needs to be
confirmed.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Canazin 100mg & 300mg (Canagliflozin) Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suited for the
manufacturing of Canazin 100mg & 300mg (Canagliflozin) Tablets.
Recommendations:
1. Since canagliflozin is falls in BCS Class IV (poor solubility and poor permeability) and the manufacturer
has also changed the manufacturing process therefore, post registration bioequivalence studies should
be conducted before marketing the product.
2. Registration of Canazin 100mg & 300mg tablets may kindly be granted in the name of the manufacturer.
Note: The firm has submitted written undertaking for post registration bioequivalence studies on the tablets
(copy enclosed).
Decision: Registration Board decided to approve registration of ―Canzin 100mg tablets (Canagliflozin 100
mg) and Canzin 300mg tablets (Canagliflozin 300mg) by M/s Indus Pharma (Pvt.) Ltd.Plot No. 26, 27, 63,
64, 65, 66 & 67, Sector 27Korangi Industrial Area, Karachi. Manufacturer will place first three
production batches of both products on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Local Availability
Applicant Dosage Form + Fee (including
Strength), differential fee), GMP Inspection Report Date &
Composition, Demanded Price / Pack Remarks
Pharmacological size
Group,
Finished Product
Specification
402. M/s Abbott Labs, Pak Brufen Duo tablet Form 5-D Combogesic 500/150 tablets
Ltd, Landhi, Karachi. Each film coated tablet Diary No. 5307 dated approved by MHRA of UK
contains:- 14-02-2018
Paracetamol …500mg Rs. 50,000/- dated 13-
Ibuprofen …… 150mg 02-2018
(Analgesic, 2 x 14‘s,
Antipyretic) 2 x 7‘s
Evaluation by PEC:
Registration Board. Moreover firm has stated that they are submitting following actual technical data of the
product along with the stability data, as the previously submitted data in the dossier was tentative data:
Details of submitted data are as under: (Dy.# 42171 dated 10-12-2018)

Drug Brufen Duo tablet
Name of Manufacturer M/s Abbott Labs, Pak Ltd, Landhi, Karachi.
Manufacturer of API Ibuprofen: M/s Shandong Xinhua Pharmaceutical Co., Ltd., China
Paracetamol: M/s Zenith Chemical Industries (Pvt.) Ltd. Lahore
API Lot No. Ibuprofen: 17112353
Paracetamol: ZPAR17-355
Description of Pack
PVC-Alu foil

Frequency Accelerated: 0,3,6 month
Real Time: 0,3,6 month
Batch No. 87654XZ 86652XZ 87653xz
Batch Size 20 Kg 20 Kg 20 Kg
Manufacturing Date 21-03-2018 27-02-2018 21-03-2018
No. of Batches 03
No.
1. COAs of APIs Yes.
2. Approval of API by regulatory authority of country of Ibuprofen: Copy of GMP certificate (Certificate#
origin or GMP certificate of API manufacturer issued SD20140251) issued by China Food and Drug
by regulatory authority of country of origin. Administration valid till 12-12-2018.
Paracetamol: Copy of DML issued by DRAP, with
issuance date of 15-06-2011
Yes
5. Documents confirming import of API etc. Ibuprofen: Copy of invoice attested by ADC
DRAP, Karachi dated 30-11-2017invoice has been
submitted.
Paracetamol: Not applicable
documents.
Yes
Yes
1978.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Brufen Duo
500mg / 150mg (Paracetamol / Ibuprofen) Tablets by M/s. Abbott Laboratories, Pakistan Limited, Landhi,
Karachi.
Reference No: F.13-11/2017-PEC(Pt) dated 18th January, 2019.

Investigation Date and Time: 28th February, 2019 (Evening).
Investigation Site: Factory premises of M/s. Abbott Laboratories, Pakistan Limited, Landhi, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Abbott Laboratories, Pakistan Limited,
Landhi, Karachi for registration of Brufen Duo 500mg / 150mg (Paracetamol / Ibuprofen) Tabletsand constituted
a three-member panel to investigate the authenticity / genuineness of data (import of raw material and stability
data). Panel was advised to conduct inspection of the firm and to submit report for further consideration.

3. Dr. Kirshan Das, Assistant Director, DRAP Office, Karachi.
BRUFEN DUO 500MG / 150MG TABLETS
Sr.
Question Observation by panel
No.
1 Do you have documents confirming the import The firm has imported 50kg Ibuprofen (Lot #
of APIs? 17112353) from M/s. Shandong Xinhua
Pharmaceutical Co., Ltd., China. 1500kg Paracetamol
(Lot # ZPAR17-355) has been purchased locally for
these batches from M/s. Zenith Chemical Industries
(Pvt) Ltd., Lahore, Pakistan.
2 What was the rationale behind selecting the There is proper vendor qualification program being
particular manufacturers of APIs? implemented by the firm which includes GMP Status,
provision of DMF, reference standard, impurity
standards etc. However, in the instant case both the
sources of both the material have already been
approved by the firm for manufacturing of other
registered products like Brufen Tablets and Cofcol
Tablets.
3 Do you have documents confirming the import The firm has documents confirming the import of
of the APIs, reference standard of the APIs and Ibuprofen. Paracetamol has been purchased locally for
impurity standards of the APIs? which there are proper documents of purchase. The
firm has also imported USP reference standards of the
APIs. An impurity standard for Paracetamol and two
major impurity standards for Ibuprofen have also been
imported from USP for which proper import
documents are available.
4 Do you have certificate of Analysis of the APIs, The firm has certificates of analysis for both APIs,
reference standards and impurity standards? reference standards of the APIs and their impurities
standards.
5 Do you have any approval of API or GMP The firm has GMP certificates of manufacturers of
certificate of API manufacturer issued by both APIs.
regulatory authority of country of origin?
6 Do you use API manufacturer method of The firm has used USP methods for testing of the
testing? APIs.
7 Do you have stability studies reports on APIs? The firm has stability studies reports on both APIs
conducted by the API manufacturers.
8 If yes, whether the stability testing has been The stability testing has been performed as per SIM
performed as per SIM method and degradation methods and degradation products have been
products have been quantified? quantified.
9 Do you have method for quantifying the The firm has method for quantifying the impurities in
impurities in the API? the APIs.
10 Do you have some remaining quantities of the The firm has some remaining quantities of the APIs,
API, its reference standard and impurities reference standards of the APIs and impurities
standards? standards.
11 Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients? The excipients include: Microcrystalline cellulose,
Pregelatinized Starch, Corn starch, Cross Carmellose

sodium, talc, magnesium stearate, methocel 15cps,
PEG 8000 and titanium dioxide.
12 Do you have documents confirming the import Except corn starch which is locally purchased all the
of the used excipients? other excipients are imported with proper import
documents.
13 Do you have test reports and other records on The firm has test reports and other records on the
the excipients used? excipients used.
14 Do you have written and authorized protocols The firm has written and authorized protocols for the
for the development of Brufen Duo tablets? development of Brufen Duo 500mg / 150mg
(Paracetamol / Ibuprofen) Tablets.
15 Have you performed Drug-excipient Drug-excipients compatibility studies were not
compatibility studies? performed as formulation of Brufen Duo tablets is the
same as that of the innovator product (Combogesic
500mg / 150mg tablets, manufactured by M/S. ICN
Polfa, Poland). The firm is advised to conduct proper
compatibility testing in future cases as impurities and
differences of sources may impact the studies.
16 Have you performed comparative dissolution The firm has performed comparative dissolution
studies? studies against the innovator product (Combogesic
500mg / 150mg tablets) while employing FDA
guidance document for comparative dissolution
profile. The firm formulation have comparable
dissolution profile with that of the innovator product.
17 Do you have product development (R&D) The firm has well equipped product development
section? laboratory with equipment for manufacturing of tablet
dosage form whereas the analytical activities are
performed in routine QC lab.
18 Do you have necessary equipment available in The firm has necessary equipment for product
product development section for development development in product development laboratory. The
of tablets? analytical work has been performed in routine QC lab
with dedicated equipments and personnel.
19 Are the equipment in product development The available equipment in product development
section qualified? section are qualified.
20 Do you have proper maintenance / calibration / The firm has SOP for the maintenance/ calibration/
re-qualification program for the equipment used requalification of equipment used on PD section.
in PD section?
21 Do you have qualified staff in product The firm has 02 qualified staff (pharmacists) in
development section with proper knowledge manufacturing part whereas 04 personnels (03
and training in product development? chemists and 01 pharmacists) in analytical part of the
product development.
22 Have you manufactured three stability batches The firm has manufactured three stability batches
for the stability studies of Brufen Duo tablets as (pilot scale, 20kg each) for the accelerated and real
required? time stability studies of Brufen Duo 500mg / 150mg
tablets with batch No. 87654XZ, 86652XZ and
87653XZ each of 24390 tablets. The tablets are
packed in PVC / Alu blisters with pack size of 2x14‘s
and 2x7‘s.
23 What was the criteria for fixing the batch size of The criteria for fixing the batch size of stability
stability batches? batches is the ICH guidelines.
24 Do you have complete record of production of The firm has complete record of production of
stability batches? stability batches. Necessary log books of equipment
used have been available with the firm.
25 Do you have protocols for stability testing of The firm has protocol for stability testing of stability
stability batches? batches.
26 Do you have developed and validated the The firm has developed and validated the method for
method for testing of stability batches? testing stability batches. The method is based upon
force degradation studies.
27 Do you have method transfer studies in case The method for testing the finish product has been
when the method of testing being used by your developed and validated by M/S. I&D, Abbott
firm is given by any other lab? Laboratory, India. The method was transferred to M/S.
Abbott Laboratories, Pakistan through testing on one
pilot scale batch manufactured by M/S. I&D, Abbott
Lab, India as test method transfer studies as per USP
requirement of method transfer.
28 Do you have documents confirming the The firm has documents confirming the qualification
qualification of equipment / instruments being of equipment / instruments being used in the test and
used in the test and analysis of API and the analysis of API and finished drug.
finished drug?
29 Do your method of analysis stability indicating? The firm‘s method of analysis is stability indicating.
The stability studies on the three stability batches
show quantification of the degradation products along
with the active components of the tablets.
30 Do your HPLC software is 21CFR compliant? The HPLC software is 21CFR Compliant as per
record available with the firm.
31 Can you show Audit Trail reports on API and The firm showed the audit trail reports on API and
finish product testing ? finish product testing.
32 Do you have some remaining quantities of The firm has remaining quantities of stability batches
degradation products and stability batches? and degradation products.
33 Do you have stability batches kept on real time The firm has completed accelerated stability testing.
stability testing? The real time stability testing is in progress on all the
three stability batches. 09 months real time stability
studies have been performed on all three batches with
satisfactory results.
34 Do you have valid calibration status for the The firm has valid calibration status for the equipment
equipment used in the production and analysis used in Brufen Duo tablets production and analysis.
of API and tablets?
35 Do proper and continuous monitoring and Continuous power supply and monitoring are
control are available for stability chamber? available for stability chambers.
36 Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel
personnel and utilities be rated as GMP and utilities are rated as GMP compliant.
compliant?
Conclusions:
for registration of Brufen Duo 500mg / 150mg (Paracetamol / Ibuprofen) Tablets is verifiable to
satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited for
the manufacturing of Brufen Duo 500mg / 150mg (Paracetamol / Ibuprofen) Tablets.
Recommendations:
1. The firm may kindly be granted necessary registration of Brufen Duo 500mg / 150mg (Paracetamol /
Ibuprofen) Tablets
Decision: Registration Board decided to approve registration of ―Brufen Duo 500mg / 150mg (Paracetamol
/ Ibuprofen) Tablets by M/s. Abbott Laboratories, Pakistan Limited, Landhi, Karachi.Manufacturer will
place first three production batches of the product on long term stability studies throughout proposed shelf
life and on accelerated studies for six months.

c. Exemption from onsite verification of stability data
Cases of Exemption form onsite Investigation form submitted stability data
Sr. Name & Address of Brand Name Type of Form, International Availability
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Date, / Local Availability
Applicant Form + Strength), Composition, Fee (including
Pharmacological Group, differential fee), GMP Inspection Report
Finished Product Specification Demanded Price / Date & Remarks
Pack size
403. M/s Genix Pharma Empag-M Tablet 12.5mg/500mg Form-5-D USFDA Approved.
Pvt. Ltd. Karachi. Tablet Dy. No: 30795 Last GMP inspection
Each film coated tablet contains: Dated.12-09-2018 conducted on 08-08-2017,
Empagliflozin ............12.5mg Rs.50,000/-(12-09- and the report concludes
Metformin hydrochloride..500mg 2018) that firm is operating at
(Anti Diabetic) 2x7‘s; As per SRO. satisfactory level of
compliance of GMP.
Evaluation by PEC:
Firm has claimed innovator‘s Specification.
Drug Each film coated tablet contains:
Empagliflozin ….............12.5mg
Metformin hydrochloride ………..500mg
Name of Manufacturer M/s Genix Pharma Pvt. Ltd. Karachi.
Manufacturer of API Empagliflozin: Ruyuan HEC Co. Pharm. Co. Ltd.
Xiaba Development Zone, Ruyuan County, Shaoguan City, Guangdong Province,
China
Metformin hydrochloride: M/s Wanbury Ltd., India
API Lot No. Empagliflozin: EGLZ-RD20171101A
Metformin hydrochloride: MT00600118, MT00610118, MT00620118
MT00630118
Description of Pack
Alu-Alu Blister Pack
Stability Storage Real time : 30°C ± 2°C / 65% ± 5% RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5% RH
Frequency Accelerated: 0,1,2,3,4,6 (month)
Real Time: 0,3,6 (month)
Batch No. 18SB-100-01 18SB-101-02 18SB-102-03
No. of Batches 3
Date of Submission 43218, 19-12-2018
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country of Empagliflozin
origin or GMP certificate of API manufacturer issued Firm has provided copy of valid GMP certificate
by regulatory authority of country of origin. of M/s Ruyuan HEC Pharm Co., Ltd, China for
Empagliflozin valid till 21-01-2019, issued by
Shaoguan FDA.
Metformin HCl
Firm also provided copy of GMP certificate of M/s
Wanbury Ltd., India for Metformin HCl valid till
28-07-2018 issued by Director, Drugs Control
Administration, Government of Andhra Pradesh -
India.
Submit valid GMP certificate.
Yes
5. Documents confirming import of API etc.
Yes

documents.
Yes
Yes
1978.
REQUEST OF EXEMPTION ROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278 th Meeting:
Administrative Portion
1. Reference of last onsite panel inspection Firm has referred to onsite inspection report of their product
for instant dosage form conducted during ―Wymly Tablets 25 mg‖, which was conducted on 9 th April,
last two years. 2018. (Afternoon) and was presented in 281st meeting of
Registration Board.
Following observations were reported in the report:
 The HPLC software is 21CFR compliant and having
certificates of Compliance by USFDA
 The firm has audit trail Reports on testing.
 Adequate monitoring and control are available for stability
chamber. Chambers are controlled and monitored through
software 21CFR compliance.
2. Documents for the procurement of API  Declaration by WIS Pharmtec Co. Ltd, China
with approval from DRAP (in case of The firm has imported Empagliflozin API 750 g from
import). M/s WIS Pharmtec Co. Ltd, China and the declaration
includes the following information.
Batch No.: EGLZ-RD20171101A
EMPAGLIFLOZIN
Mfg Date: 01-11-2017

 Details of ADC attested commercial Invoice by
WIS Pharmtec Co. Ltd, China
Invoice No. WIS170152
Quantity imported: 0.75 Kg
Date of import: 29-06-2016
ADC Attestation Date: 07-12-2017
Manufacturer: Ruyuan HEC Co. Pharm. Co. Ltd.
Xiaba Development Zone, Ruyuan County, Shaoguan
City, Guangdong Province, China.
Commercial invoice doesnot mention the batch no.

 Details of ADC Attested invoice commercial
Invoice by WanburyLtd., India
Firm has imported Metformin HCl from M/s Wanbury
Ltd., India and has approval from DRAP for import.
METFORMIN HCL
Date of Import: 05 May 2015
Invoice No.:EXP/92001577/17-18
ADC Attested invoice:30-01-2018
Batch No. Quantity imported
MT00600118 1280kg
MT00610118 1280kg
MT00620118 1280kg
MT00630118 1160kg
3. Documents for the procurement of Empagliflozin Working Standard

reference standard and impurity Source Quantity Date of
Batch No.
standards. imported declaration
Ruyuan 09-07-2018
EGLZ-
HEC 2g
WS20161201
Pharm Co.
Metformin HCL
Commercial invoice no: 29829781
Copy of commercial invoice from USP for reference standards
of Metformin HCl & impurity standards.
4. Approval of API/ DML/GMP certificate Empagliflozin
of API manufacturer issued by regulatory Firm has provided copy of GMP certificate of M/s Ruyuan HEC
authority of country of origin. Pharm Co., Ltd, China for Empagliflozin valid till 21-01-2019,
issued by Shaoguan FDA.
Metformin HCl
Copy of GMP certificate issued by DCA Andhra Pradesh valid
upto 05-02-2022 for M/s Wanbury Ltd., West Godavari District,
Andhra Pradesh, India has been submitted.
5. Mechanism for Vendor pre-qualification  The firm has submitted Vendor evaluation Form.
 Copy of Vendor Certification Questionnaire filled for M/s
Ruyuan HEC Pharm Co., Ltd.
Wanbury Ltd., Dist. Raigad, Maharashtra State, India.
6. Certificate of analysis of the API,  Copies of COAs of API‘s have been submitted, detailed as
reference standards and impurity under:
standards API Batch. # Source
Empagliflozin EGLZ- HEC Ruyuan
RD20171101A Pharm
Empagliflozin Working EGLZ- HEC Ruyuan
standard WS201612101 Pharm
Metformin HCL MT00600118 USP
USP
Metformin Related R072Y0 USP
Compound A
Melamine G1M492 USP
7. Documents for the procurement of The firm has submitted commercial invoices of the excipients
excipients used in product development? used in formulation from relevant manufacturers.
Excipient Commercial Invoice
Maize Starch Mak Kemikal, 400kg,
PVP K30 Mak Kemikal, 300kg
Aerosil 200 Mak Kemikal, 100kg
Opadry II white Colorcon, 41.97 kg
Magnesium Stearate Premium Chemicals, 200Kg
PVP Copovidone Zhejiang Neo-Dankong
Pharmaceutical, 10Kg
Black Currant Far Eastern impex, Pakistan, Qty.
5kg
Dye, Red Iron oxide Dawawala Chemical Corp.,50Kg
Excipient Source Batch No.

Copovidone Boai NKY P170822002
Pharmaceuticals, China
Corn Starch Gujarat Ambuja Exports, 418
India
Colloidal Evonik 137070130
Silicon
Dioxide
Magnesium Huzhou City Linghu 20180118
Stearate Xinwang Chemical Co,
China
Opadry II Colorcon DT661438
white
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff along
development with relevant experience. with their training record involved in product development.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of following documents for
development & stability testing of trial development of Empag-M 12.5/500mg tablet
batches. a. Development protocol.
b. Stability Study Protocol.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing
three stability batches. Record and Batch Packaging Record of three stability batches
for the stability studies of Empag-M 5/1000mg tablets such as.
Batch No. Date of Mfg. Batch Size
18SB-100-01 04-2018 1500 Tablets
18SB-101-02 04-2018 1500 Tablets
18SB-102-03 04-2018 1500 Tablets
11. Record of remaining quantities of 18SB-100-01 18SB-101-02 18SB-102-03
stability batches. Batch size: 1500 Tablets
Received for Stability: 200 Tablets
Balance: Nil (40C/75%rH)
Balance: 168 (30C/65%rH)
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of digital printouts of
temperature and humidity monitoring of graphical chart for Real Time and Accelerated Conditions.
stability chambers (real time and
accelerated)
13. Method used for analysis of API along The firm has applied supplier‘s method for analysis of API and
with COA. has submitted analytical reports, raw data sheets & relevant
chromatograms.
14. Method used for analysis of FPP &  The firm has submitted photocopy of Finished Product
complete record of testing of stability specification & Test method.
batches (i.e. chromatograms, lab reports,  Firm has submitted complete record of testing of stability
raw data sheets etc.) batches (i.e. chromatograms, lab reports, raw data sheets
etc.)

15. Reports of stability studies of API from Empagliflozin
manufacturer. The firm has submitted copies of reports of 06 Months
Accelerated and 24 Months Real Time Stability Study (30oC+2
o
C, 65+5%) Data of 03 Batches of API.
Metformin HCl
The firm has submitted copies of reports of 06 Months
Accelerated and 24 Months Real Time Stability Study (30 oC+2
o
16. Analysis reports for excipients used. The firm has submitted copies of its own Analytical reports for
all excipients used in product development.
17. Drug-excipients compatibility studies.  Not submitted by the firm.
Firm has stated that composition of developed product is similar
to innovator‘s product formulation. Therefore it is presumed that
used inactive ingredients are compatible with active & also with
each other and this is ensured by satisfactory results from formal
stability studies.
18. Record of comparative dissolution data. pH 0.1N , Acetate buffer 4.5, Buffer 6.8.
Feature Reference Genix
product Product
Brand name Synjardy
Batch No. 706521 18SB-100-01
Mfg. date 03-2018 04-2018
19. Compliance Record of HPLC software Firm has submitted audit trail reports for complete stability
21CFR & audit trail reports on product studies analysis of three batches.
testing.

No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Date, Availability / Local
Applicant Form + Strength), Composition, Fee (including Availability
Pharmacological Group, differential fee),
Finished Product Specification Demanded Price / GMP Inspection Report
Pack size Date & Remarks
404. M/s Genix Pharma Empag-M Tablet 12.5mg/1000 Form-5-D USFDA Approved.
Pvt. Ltd. Karachi. mg Dy. No: 30796 Last GMP inspection
Tablet Dated.12-09-2018 conducted on 08-08-
Each film coated tablet contains: Rs.50,000/- (12-09- 2017, and the report
Empagliflozin.............12.5mg 2018) concludes that firm is
Metformin hydrochloride 2x7‘s; As per SRO. operating at satisfactory
………..1000mg level of compliance of
(Anti Diabetic) GMP.
Evaluation by PEC:
Empagliflozin ….............12.5mg
China
MT00630118
Description of Pack
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Batch No. 18SB-103-01 18SB-103-02 18SB-103-03
No. of Batches 3
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of Empagliflozin
country of origin or GMP certificate of API Firm has provided copy of valid GMP certificate of M/s
manufacturer issued by regulatory authority of Ruyuan HEC Pharm Co., Ltd, China for Empagliflozin
country of origin. valid till 21-01-2019, issued by Shaoguan FDA.
Metformin HCl
Firm also provided copy of GMP certificate of M/s
Wanbury Ltd., India for Metformin HCl valid till 28-07-
2018 issued by Director, Drugs Control Administration,
Government of Andhra Pradesh - India.
3. Protocols followed for conduction of stability
Yes
respective documents like chromatograms, Yes
Yes

sign and stamp) for ensuring authenticity of data Yes
/ documents.
7. Commitment to continue real time stability
Yes
8. Commitment to follow Drug Specification
Yes
Rules, 1978.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board in its 278 th
Meeting:
for instant dosage form conducted during ―Wymly Tablets 25 mg‖, which was conducted on 9 th April,
Registration Board.

EMPAGLIFLOZIN
Mfg Date: 01-11-2017
METFORMIN HCL

Batch No. Quantity imported
MT00600118 1280kg
MT00610118 1280kg
MT00620118 1280kg
MT00630118 1160kg

reference standard and impurity Source Quantity Date of
Batch No.
standards. imported declaration
Ruyuan HEC EGLZ- 09-07-2018
Pharm Co. WS20161 2g
201
Metformin HCL
of API manufacturer issued by regulatory Firm has provided copy of GMP certificate of M/s Ruyuan
authority of country of origin. HEC Pharm Co., Ltd, China for Empagliflozin valid till 21-01-
2019, issued by Shaoguan FDA.
Metformin HCl
 Copy of GMP certificate issued by DCA Andhra Pradesh
valid upto 05-02-2022 for M/s Wanbury Ltd., West
Godavari District, Andhra Pradesh, India has been
submitted.
RD20171101A Pharm
Empagliflozin Working EGLZ- HEC Ruyuan
standard WS201612101 Pharm
USP
Metformin Related R072Y0 USP
Compound A
Melamine G1M492 USP
Opadry II white Colorcon, 41.97 kg DT661438
Magnesium Premium Chemicals,
Stearate 200Kg
Black Currant Far Eastern impex,
Pakistan, Qty. 5kg
Dye, Red Iron Dawawala Chemical
oxide Corp.,50Kg

Pharmaceuticals, China
Corn Starch Gujarat Ambuja Exports, 418
India
Silicon Dioxide
Magnesium Huzhou City Linghu 20180118
Stearate Xinwang Chemical Co,
China
Opadry II white Colorcon DT661438
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff
development with relevant experience. along with their training record involved in product
development.
Production Data
development & stability testing of trial development of Empag-M 12.5/1000mg tablet
batches. a. Development protocol.
18SB-103-01 04-2018 1500 Tablets
18SB-104-02 04-2018 1500 Tablets
18SB-105-03 04-2018 1500 Tablets
11. Record of remaining quantities of 18SB-103-01, 18SB-104-02, 18SB-105-03
QA / QC DATA
accelerated)
chromatograms.
raw data sheets etc.) batches (i.e. chromatograms, lab reports, raw data sheets etc.)
o
Metformin HCl
Accelerated and 24 Months Real Time Stability Study (30oC+2
o
stability studies.
Feature Reference product Genix Product
Brand name Synjardy
Batch No. 605012 18SB-103-01
Mfg. date 01-2018 04-2018
testing.

Pharmacological Group, differential fee), GMP Inspection
Finished Product Specification Demanded Price / Report Date &
Pack size Remarks
405. M/s Genix Pharma Empag-M Tablet 5mg/1000 mg Form-5-D USFDA Approved.
Pvt. Ltd. Karachi. Each film coated tablet contains: Dy. No: 30794 Last GMP inspection
Empagliflozin ….............5mg Dated.12-09-2018 conducted on 08-08-
Metformin hydrochloride Rs.50,000/- (12-09- 2017, and the report

………..1000mg 2018) concludes that firm is
(Anti Diabetic)\ 2x7‘s; As per SRO. operating at satisfactory
Innovator Specs. level of compliance of
GMP.
Evaluation by PEC:
Empagliflozin ….............5mg
China
MT00630118
Description of Pack
Batch No. 18SB-097-01 18SB-098-02 18SB-099-03
No. of Batches 3
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country of Empagliflozin
origin or GMP certificate of API manufacturer issued Firm has provided copy of valid GMP certificate
by regulatory authority of country of origin. of M/s Ruyuan HEC Pharm Co., Ltd, China for
Empagliflozin valid till 21-01-2019, issued by
Shaoguan FDA.
Metformin HCl
Firm also provided copy of GMP certificate of
M/s Wanbury Ltd., India for Metformin HCl
valid till 28-07-2018 issued by Director, Drugs
Control Administration, Government of Andhra
Pradesh - India.
3. Protocols followed for conduction of stability study and
Yes
details of tests.
Yes
6. All provided documents will be attested (name, sign Yes

th
and stamp) for ensuring authenticity of data /
documents.
Yes
the following documents in conjunction with the checklist approved by the Registration Board in its 278th
Meeting:
for instant dosage form conducted during ―Wymly Tablets 25 mg‖, which was conducted on 9th April,
Registration Board.
EMPAGLIFLOZIN
Mfg Date: 01-11-2017

METFORMIN HCL
Quantity
Batch No.
imported
MT00600118 1280kg
MT00610118 1280kg
MT00620118 1280kg
MT00630118 1160kg

reference standard and impurity Source Batch Quantity Date of declaration
standards. No. imported
Ruyuan HEC EGLZ- 09-07-2018
Pharm Co. WS201 2g
61201
Metformin HCL
of API manufacturer issued by regulatory Firm has provided copy of GMP certificate of M/s Ruyuan HEC
authority of country of origin. Pharm Co., Ltd, China for Empagliflozin valid till 21-01-2019,
issued by Shaoguan FDA.
Metformin HCl
upto 05-02-2022 for M/s Wanbury Ltd.,West Godavari District,
Andhra Pradesh, India
RD20171101A Pharm
Working WS201612101 Pharm
standard
USP
Metformin R072Y0 USP
Related
Compound A
Melamine G1M492 USP
Commercial Invoice of Colorcon required.
Opadry II white Colorcon, COA not DT661
commercial invoice 438
Magnesium Premium Chemicals, 200Kg
Stearate
Yellow Iron Dawawala Chemical
Oxide Coorporation, 5 kg

Pharmaceutic 2
als, China
Corn Starch Gujarat 418
Ambuja
Exports,
India
Silicon
Dioxide
Magnesium Huzhou City 20180118
Stearate Linghu
Xinwang
Chemical Co,
China
Opadry II Colorcon DT661438
white
development.
Production Data
development & stability testing of trial development of Empag-M 5/1000mg tablet
batches. c. Development protocol.
d. Stability Study Protocol.
18SB-097-01 04-2018 1500 Tablets
18SB-098-02 04-2018 1500 Tablets
18SB-099-03 04-2018 1500 Tablets
11. Record of remaining quantities of 18SB-097-01,18SB-098-02,18SB-099-03
QA / QC DATA
accelerated)
chromatograms.
raw data sheets etc.) batches (i.e. chromatograms, lab reports, raw data sheets
etc.)

o
Metformin HCl
o
to innovator‘s product formulation. Therefore it is presumed
that used inactive ingredients are compatible with active & also
with each other and this is ensured by satisfactory results from
formal stability studies.
Feature Reference Genix
product Product
Brand name Synjardy
Batch No. 802167 18SB-097-01
Mfg. date 02-2018 04-2018
testing.
Sr.# Name & Brand Name Type of Form, International REMARKS

Address of (Proprietary Name + Initial Diary & Date, Availability / (IF ANY)
Manufacturer / Dosage Form + Strength), Fee (including Local
Applicant Composition, differential fee), Availability
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
Specification Remarks
406. "M/s Genix Empag-M Tablet 5mg/500 Form-5D Dy. No Approved by
Pharma Pvt Ltd, mg 30793 dated 12-09- USFDA
44-45/B, "Each film coated tablet 2018 Rs.50,000/- Last GMP
Korangi Creek contains: Dated 12-09-2018 inspection
Raod, Karachi‖ Empagliflozin …… 5mg 10‘s, 14‘s20‘s, 28‘s & conducted on 16-
Metformin HCl ….. 30‘s 02-
500mg" As per SRO 2018concluding
(Antidiabetic) satisfactory level
of cGMP
compliance..
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Empag-M Tablet 5mg/500 mg
Name of Manufacturer M/s Genix Pharma Pvt Ltd, 44-45/B, Korangi Creek Raod, Karachi
Manufacturer of API Empagliflozin: M/s Ruyuan HEC Pharm Co., Ltd. China
Metformin HCl: M/s Wanbury Ltd., Dist. Raigad, Maharashtra State., India
Metformin HCl: MT00600118
Description of Pack Alu-Alu blister foil with unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months) Accelerated: 0,1,2,3,4 & 6 (months)
Batch No. 18SB-093-01 18SB-095-02 18SB-096-03
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Sr.# Documents To Be Provided Status
i. COA of API Yes
ii. Approval of API by regulatory Empagliflozin:
authority of country of origin or GMP Copy of GMP certificate (2017029) issued by M/s Shaoguan
certificate of API manufacturer issued Food & Drug Administration, valid upto 21-01-2019 for M/s
by regulatory authority of country of Ruyuan HEC Pharm Co., Ltd.
origin. Metformin HCl:
upto 05-02-2022 for M/s Wanbury Ltd.,West Godavari District,
Andhra Pradesh, India
iii. Protocols followed for conduction of
Yes
stability study and details of tests.
iv. Data of 03 batches will be supported by
Yes
chromatograms, laboratory reports, data
sheets etc.
v. Documents confirming import of API Empagliflozin:
etc. Copy of Commercial Invoice signed & stamped by ADC DRAP, Islamabad
of Empagliflozin has been attached.
Batch No. Invoice No. Quantity

Imported.
EGLZ- WIS170152 750gm
RD20171101A
Metformin HCl:
Copy of Commercial Invoice signed & stamped by ADC DRAP, Islamabad
of Metformin HCl has been attached.
vi. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
authenticity of data / documents.
vii. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
viii. Commitment to follow Drug
Yes
Specification Rules, 1978.
REMARKS OF EVALUATOR2
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale
Batches.

REQUEST OF EXEMPTION FROM ON SITE INSPECTION
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of Empag-
M Tablets tablets vide Letter no. RA/223//18, dated 21-12-2018 and provided the following documents in
conjunction with the checklist approved by the Registration Board in its 278 th Meeting:
(Date of submission: 26-12-2018 vide diary no. 43816)
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product ―Wymly
inspection for instant dosage form 25mg Tablets‖, which was conducted on 9th Apr, 2018 and was
conducted during last two years. presented in 281st meeting of Registration Board held on 11th – 13th
April, 2018.
Registration Board decided to approve registration of ―Wymly 25mg
Tablets (Tenofovir alafenamide as fumarate)Tablets
i. The HPLC software is 21CFR compliant.
ii. The firm has audit trail Reports on testing.
iii. Adequate monitoring and control are available for stability
software 21CFR compliance
2. Documents for the procurement of Empagliflozin:
API with approval from DRAP (in Copy of Commercial Invoice signed & stamped by ADC DRAP,
case of import). Islamabad dated 07-12-2017 for the import of Empagliflozin has
been attached.
Batch No. Invoice No. Quantity
Imported.
EGLZ- WIS170152 750gm
RD20171101A
Metformin HCl:
Copy of Commercial Invoice signed & stamped by ADC DRAP,
Islamabad dated 30-01-2018 for the import of Metformin HCl has
been attached.
3. Documents for the procurement of Empagliflozin:
reference standard and impurity Firm has submitted a copy of declaration dated 09-07-2018 from M/s
standards. Ruyuan HEC Pharm Co., Ltd. China, stating submission of 2gm
Empagliflozin working standard (batch# EGLZ-WS201612101) to
M/s Genix Pharma (Pvt.) Ltd.
Metformin HCl:
Copy of commercial invoice from USP for reference standards of
Metformin HCl & impurity standards.
4. Approval of API/ DML/GMP Empagliflozin:
certificate of API manufacturer issued
Copy of GMP certificate (2017029) issued by M/s Shaoguan Food &
by regulatory authority of country of
Drug Administration, valid upto 21-01-2019 for M/s Ruyuan HEC
origin. Pharm Co., Ltd.
Metformin HCl:
Copy of GMP certificate issued by DCA Andhra Pradesh valid upto
05-02-2022 for M/s Wanbury Ltd.,West Godavari District, Andhra
Pradesh, India
5. Mechanism for Vendor pre-  The firm has submitted copy of SOP for Vendor Certification.
qualification  Copy of Vendor Certification Questionnaire filled for M/s
 Copy of Vendor Certification Questionnaire filled for M/s
6. Certificate of analysis of the API, The firm has submitted certificate of analysis for Empagliflozin,
reference standards and impurity working standard for Empagliflozin and Metformin HCl.
standards USP certificates for reference standard &impurity standards of
Metformin HCl has been submitted.
7. Documents for the procurement of The firm has submitted photocopy of Purchase Order/Invoices for the
excipients used in product procurement of excipients used in product development
development?
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified staff (4
product development with relevant members) involved in product development.
experience.
Production Data
9. Authorized Protocols/SOP for the  The firm has submitted photocopy of following documents for
development & stability testing of development of Empag-M 5/500mg tablet
trial batches. a. Development protocol.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing Record
of three stability batches. and Batch Packaging Record of three stability batches for the
stability studies of Empag-M 5/500mg tablets such as.

18SB-093-01 04-2018 1500 Tablets
18SB-095-02 04-2018 1500 Tablets
18SB-096-03 04-2018 1500 Tablets
11. Record of remaining quantities of The firm has submitted sample utilization record for three trial
stability batches. batches kept in stability chambers for accelerated & long term
stability studies.
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital printouts for Real
temperature and humidity monitoring Time and Accelerated Conditions for complete stability studies of
of stability chambers (real time and applied formulations
accelerated)
13. Method used for analysis of API  The firm has submitted photocopy of raw material specifications,
along with COA. raw material testing procedures, COA and analytical record
including chromatograms for both Empagliflozin & Metformin
HCl.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
complete record of testing of stability Procedure for Empag-M 5/500 mg tablets along with Stability Study
batches (i.e. chromatograms, lab Report of stability batches, lab reports, raw data sheets etc.
reports, raw data sheets etc.)
15. Reports of stability studies of API Empagliflozin: The firm has submitted stability studies reports for
from manufacturer. both Accelerated (40°C ± 2°C / 75% ± 5%RH) for 6 months & Long
term (30°C ± 2°C / 65% ± 5%RH) conditions for 24 months from
manufacturer.
Metformin HCl:
The firm has submitted stability studies reports for both Accelerated
(40°C ± 2°C / 75% ± 5%RH) for 6 months & Long term (30°C ± 2°C /
65% ± 5%RH) conditions for 72 months from manufacturer.
16. Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical reports for
all excipients used in product development of Empag-M 5/500 mg
tablets.
 Firm has stated that composition of developed product is similar
stability studies.
18. Record of comparative dissolution  Firm has submitted Comparative Dissolution Profile protocol &
data.
reports. The details of reference product & Sample product are as
follows:
Feature Reference Product of M/s
product Genix
Brand name Synjardy 5/500mg Empag-M 5/500mg
tablet tablet
Batch No. 803151 18SB-093-01
Expiry date 02-2021 --
 Comparative dissolution studies have been performed in
following mediums:
a. 0.1N HCl buffer
b. pH 4.5 Acetate buffer
c. pH 6.8 Phosphate buffer
 Firm has submitted relevant chromatograms and results for the
CDP study showing acceptable f2 values.
19. Compliance Record of HPLC  Firm has submitted audit trail reports of stability studies of
software 21CFR & audit trail reports applied formulation
on product testing.
 Raw material analytical test method of Empagliflozin submitted by firm differs from supplier‘s testing
method as per following details:
Test parameter Method of M/s Method of M/s Genix
Ruyuan HEC
Detector wavelength of 210 223
HPLC for Assay test
 Clarify why potency adjustment not done for Empagliflozin and Metformin as assay is 99.20% and 99.69%,
respectively.
 Test for ―Content of Uniformity‖ for Empagliflozin has not been performed for all three stability batches.
Upon communication of above observation vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated 18-01-
2019. Firm responded as under vide its letter no. RA/038/19 (dated 12-02-2019):
 Empagliflozin shows its maxima at 223nm. Reference spectrum of Empagliflozin is attached. Revised method
from supplier of Empagliflozin with wavelength at 223nm has been submitted.
 Test for ―Content of Uniformity‖ for Empagliflozin has been performed for all three stability batches at the
most recent time point of long term stability studies.
 Firm has submitted that ―we have revised the SOP of Product development for potency adjustment of Active
Raw materials and potency will be adjusted upto 100% for all trial products as we dispense after adjustment
the potency upto 100% for commercial batches. It I sour practice for all API dispense after potency
adjustment for commercial products.‖
Decision:Registration Board decided to approve registration of ―Empag-M Tablet 5mg/500mg
(Empagliflozin/Metformin hydrochloride), Empag-M Tablet 5mg/1000mg (Empagliflozin/Metformin
hydrochloride), Empag-M Tablet 12.5mg/1000mg (Empagliflozin/Metformin hydrochloride) and Empag-M
Tablet 12.5mg/500mg (Empagliflozin/Metformin hydrochloride) by M/s M/s Genix Pharma Pvt. Ltd.
Karachi. Manufacturer will place first three production batches of all products on long term stability
studies throughout proposed shelf life and on accelerated studies for six months

No Manufacturer / (Proprietary Name + Initial Diary & Date, Local Availability
. Applicant Dosage Form + Fee (including
Strength), differential fee), GMP Inspection Report
Composition, Demanded Price / Pack Date & Remarks
Group,
Finished Product
Specification
407. M/s Neutro Pharma Dacla 60mg tablets Form 5 Approved by USFDA
(Pvt.) Ltd. Lahore, Each film coated Dy.# 35251 dated 23-10-
Pakistan. tablet contains:- 2018 Last GMP inspection report
Daclatasvir Rs. 20,000/- 23-10-2018 dated 18-07-2017 concluding
dihydrochloride eq. to 28‘s, As per SRO that firm has maintained a
Daclatasvir… 60mg fair level of GMP
(NS5A Inhibitor) compliance.
Evaluation by PEC:
Firm has submitted 6 months accelerated and Long term stability studies detailed as under:
Drug Dacla 60mg tablets
Name of Manufacturer M/s Neutro Pharma (Pvt.) Ltd. Lahore, Pakistan.
Manufacturer of APIs M/s Ruyuan HEC Pharm, Guangdong, China.
API Lot No. DSV-RD20106101
Description of Pack
Unit carton
Frequency Accelerated: 0,1,2,3,4 & 6 month
Real Time: 0,3,6 month
Batch No. HTB 003 HTB 004 HTB 005
No. of Batches 03
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country of origin Copy of GMP certificate issued by Shaoguan
or GMP certificate of API manufacturer issued by regulatory Food and Drug Administration valid upto 17-06-
authority of country of origin. 2018.
Protocols followed for conduction of stability study and
Yes
details of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data Yes
sheets etc.

Documents confirming import of API etc. Copy of commercial invoice attested by ADC
DRAP, Lahore dated 11-07-2017.
All provided documents will be attested (name, sign and Yes
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned Yes
shelf life of the product.
Commitment to follow Drug Specification Rules, 1978. Yes
 Dissolution method submitted by you in finished product testing method is different from that
recommended by USFDA.
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of and
provided the following documents in conjunction with the checklist approved by the Registration Board in its
278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection reports of their product
inspection for instant dosage form ―NUVALDI Tablets 400mg (Sofosbuvir)‖, which was presented
conducted during last two years. in 281st meeting of Registration Board wherein Registration Board
decided to approve registration of ―NUVALDI Tablets 400mg
(Sofosbuvir) by M/s. Neutro Pharma (Pvt.) Ltd., Lahore.
Following observations were recorded in the report:
 Firm have used HPLC system from KNAUR (Germany) for
testing of stability batches. Software ClarityChrom® which is
21CFR Compliant. 02 Users (QCM - Mr. Shahzad and
Analyst - Ms. Sumbul) have access to the HPLC software as
observed at the time of inspection. However the analyst had
access to QCM‘s account as well. The firm was advised to
change this practice at once.
 Firm have shown audit trail reports on stability study testing.
2. Documents for the procurement of API Copy of Commercial invoice (invoice# WIS70072) dated 28-06-
with approval from DRAP (in case of 2017, from M/s WIS Pharmatech Co., Ltd, China in the name of
import). M/s Neutro Pharma (Pvt.) Ltd. Lahore for Daclatasivr
dihydrochloride. The said invoice has been attested by AD DRAP
(I&E) Lahore, dated 14-07-2014.
Batch No. Mfg. Date Quantity
Imported.
DSV- 09-06-2017 1.5Kgs
RD201706101
3. Documents for the procurement of Firm has submitted a copy of a label declaring content as
reference standard and impurity ―Daclatasvir reference standard‖ with Batch# PRS-17023 &
standards. quantity 100mg. Manufacturer is M/s Ruyuan HEC Pharm Co.,
Ltd. China.
No document for impurity standard has been submitted.
4. Approval of API/ DML/GMP Copy of GMP certificate issued by Shaoguan Food and Drug
certificate of API manufacturer issued Administration valid upto 17-06-2018.
by regulatory authority of country of
origin.
5. Mechanism for Vendor pre-  The firm has submitted SOP for Vendor Supplier Evaluation.
qualification
6. Certificate of analysis of the API, Photocopy of COA of Daclatasivr dihydrochloride with Batch No.
reference standards and impurity DSV-RD201706101 by M/s Ruyuan HEC Pharm Co., Ltd. China
standards is submitted.
Reference standards: Qualification report of reference standard
of Batch No. PRS-17023 R/RD/60121118 by M/s
Ruyuan HEC Pharm Co., Ltd. China is submitted.
No document for impurity standard has been submitted.
7. Documents for the procurement of Submitted
excipients used in product
development.
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified staff
product development with relevant involved in product development comprising of 5 members.
experience.
Production Data
9. Authorized Protocols/SOP for the  The firm has submitted photocopy of SOP for Real time &
development & stability testing of trial
Accelerated Stability along with manufacturing protocol for
batches. all three trial batches of Dacla 60mg tablet.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing
of three stability batches. Record of three stability batches of Dacla 60mg tablet, such as.
Dacla 60mg tablet
HTB-003 01-2018 2222 Tablets
HTB-004 01-2018 2222 Tablets
HTB-005 01-2018 2222 Tablets
11. Record of remaining quantities of The firm has submitted reconciliation sheet mentioning following
stability batches. details:
Dacla 60mg tablet
Batch No. Remaining Quantity
HTB-003 280
HTB-004 252
HTB-005 308
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital printouts for
temperature and humidity monitoring Accelerated Long term conditions for complete stability studies of
of stability chambers (real time and applied formulations.
accelerated)
13. Method used for analysis of API along The firm has submitted photocopy of COA & testing procedures
with COA. for Daclatasvir dihydrochloride from M/s Ruyuan HEC Pharm,
China, along with relevant FTIR spectrums and chromatograms
for the API analysis.
complete record of testing of stability Procedure Dacla 60mg Tablet along with Stability Study Report
batches (i.e. chromatograms, lab of stability batches, chromatograms, lab reports, raw data sheets
reports, raw data sheets etc.) etc.
15. Reports of stability studies of API from The firm has submitted stability studies reports for both
manufacturer. Accelerated (40°C ± 2°C / 75% ± 5%RH) for 6 months & Long
manufacturer.
16. Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical reports
for all excipients used in product development of Dacla tablets.
17. Drug-excipients compatibility studies.  The firm has submitted analytical record for drug excipient
compatibility studies.
18. Record of comparative dissolution data.  Firm has submitted Comparative Dissolution reports. The
details of reference product & Sample product are as follows:
Feature Reference product Product of M/s Neutro
Brand name Mydacla 60mg of Dacla 60mg tablet

m/s Mylan India
 Comparative dissolution studies have been performed in 0.1M
HCl buffer.
 Firm has submitted relevant UV spectrums and results for the
CDP study.
 Firm has performed CDP in one buffer medium only for 6
tablets only, whereas as per guidelines CDP shall be
performed in three dissolution mediums using 12 units each
of reference and sample product.
19. Compliance Record of HPLC software  Firm has submitted audit trail reports of stability studies
21CFR & audit trail reports on product of applied formulation
testing.
Observation Response
Submitted digital data logging record of Firm has replied as under:
accelerated stability chamber shows fall in ―It is clarified that the product was placed for accelerated
humidity measurement from 70% for the time stability studies at 40°C ± 2°C / 75% ± 5%RH. During the
period dated 06-03-2018 to 23-03-2018 as well said period of time when humidity ranges were out of limit,
as in the month of April, 2018 7 August, 2018. the climate chamber of accelerated stability studies was out
Clarification shall be submitted in this regard of order and the product was shifted to a parallel accelerated
stability chamber which was being operated at the same
conditions of temperature and humidity (40°C ± 2°C / 75% ±
5%RH) to avoid any effect on the study. So, it is assured that
throughout the accelerated stability period, the product was
exposed to optimum conditions of temperature and humidity
for accelerated stability studies.‖
Relevant chromatograms, FTIR spectrum, lab As per submitted analytical record for API analysis, firm has
reports, raw data sheets & COAs of API not applied supplier‘s method of analysis for Assay analysis
analysis by M/s Neutro Pharma (Pvt.) Ltd. since the elution program mentioned in supplier‘s method of
Lahore shall be submitted. analysis is gradient with run time of 35 minutes, whereas
submitted chromatograms show run time of only 10 minutes.
Relevant analytical record i.e., chromatograms, Firm has submitted UV spectrums and raw data sheets for the
raw data sheets for dissolution analysis for the dissolution analysis for the complete stability studies.
complete stability studies have not been
submitted.
Finished product testing method mentions Firm has stated that ―Practically we used UV method for
HPLC method for dissolution analysis whereas dissolution test, but mistakenly not written in SOP while
CDP samples have been analysed by UV HPLC method was lodged. We have rectified and providing
spectrophotometric method. you UV method for dissolution test in SOP for Declatasvir
60mg tablet. Next time we shall try to avoid such mistakes.
Firm has performed CDP in one buffer Firm has submitted new data for CDP in one buffer of 0.1N
medium only for 6 tablets only, whereas as per HCl, using 12 tablets each of both reference product
guidelines CDP shall be performed in three (Mydacla) and the trial product. F2 factor = 78.42 has been
dissolution mediums using 12 units each of calculated by firm for the said CDP study.
reference and sample product.
 Dissolution method submitted by firm in finished product testing method is different from that
recommended by USFDA in terms of Dissolution medium since firm has used 0.1M HCl while USFDA has
recommended Phosphate Buffer, pH 6.8 with 0.75% Brij 35, as dissolution medium.
 The dossier has been submitted with brand name of ―Dacla 60mg tablets‖, whereas most of the stability
studies have been performed with Product name as Hepadec tablet.
Decision: Registration Board deferred the case for following reasons:
 Documeneted evidence for the activity of shifting the samples of applied product to a parallel
accelerated stability chamber, during the period when humidity ranges were out of limit for the
parent Accaelerated stability studies chamber.
 Performance of dissolution test on the next time point of long term stability studies as per USFDA
recommended method for all three stability batches.
Sr. Name & Address Brand Name Type of Form, International REMARKS
# of Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / (IF ANY)
Applicant Dosage Form + Strength), Fee (including Local Availability
Composition, differential fee),
408. M/s Saffron Xpedia-Met Form-5D (Duplicate) Approved by
Pharmaceuticals 12.5mg/500mg Tablets Dy. dated 06-03-2015 USFDA
Pvt Ltd., 19-Km, "Each film coated tablet Rs.50,000/- Dated 03- Last GMP
Sheikhupura contains: 04-2015 (Photocopy inspection
Road, Faisalabad Alogliptin as benzoate attested by ABL conducted on 13-
…… 12.5mg spinning mills 10-
Metformin HCl .. 500mg" Faislabad) 2017recommendi
(Antidiabetic) 30‘s/ Rs. 650/- ng renewal of
DML.
Drug Xpedia-Met 12.5mg/500mg Tablets
Name of Manufacturer M/s Saffron Pharmaceuticals Pvt Ltd., 19-Km, Sheikhupura Road, Faisalabad
Manufacturer of API Alogliptin Benzoate: M/s Ruyuan HEC Pharm Co., Ltd. China
Metformin HCl: M/s IPCA Lab. Aurangabad, India
API Lot No. Alogliptin benzoate: AGLT II-201608101U
Metformin HCl: 17322ML 2RMI
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months
Real Time: 6 Months
Frequency Real Time: 0,3,6,9 7 12(months)
Accelerated: 0,1,2,3,4 & 6 (months)
Batch No. T-002 T-003 T-004
No. of Batches 03
COA of API Yes
Approval of API by regulatory authority Firm has submitted copy of GMP certificate of Alogliptin
of country of origin or GMP certificate Benzoate for M/s Ruyuan HEC Pharm Co Ltd. China Issued by
of API manufacturer issued by Shaoguan Food and Drug Administration China valid upto 18-
regulatory authority of country of origin. 12-2019.
Firm has submitted copy of GMP Certificate (certificate no.
GMP/17/2014-157-3) of Metformin for M/s IPCA Lab.
Aurangabad, India Issued by FDA Maharashtra State
Aurangabad dated 28-07-2014. Validity of certificate is not
evident for submitted document.
Protocols followed for conduction of
stability study and details of tests. Yes

Data of 03 batches will be supported by
Yes
sheets etc.
Documents confirming import of API Alogliptin Benzoate
etc. Firm has submitted copy of ADC attested invoice (Invoice#
PH60093) confirming import of 1.5 Kg Alogliptin from WIS
Pharmatech. The invoice was cleared on 08.11.2016.
Metformin
Firm has submitted copy of ADC attested invoice confirming
import of 500 Kg Metformin HCl from IPCA Lab. Ltd., India.
The invoice was cleared on 15-12-2016.
All provided documents will be attested
Commitment to continue real time
the product.
Commitment to follow Drug
Yes
Batches.
Sr. Name & Address Brand Name Type of Form, International REMARKS
# of Manufacturer / (Proprietary Name + Initial Diary &Date, Availability / (IF ANY)
Applicant Dosage Form + Strength), Fee (including Local Availability
409. M/s Saffron Xpedia-Met Form-5D (Duplicate) Approved by
Pharmaceuticals 12.5mg/1000mg Tablets dated 06-03-2015 USFDA
Pvt Ltd., 19-Km, "Each film coated tablet Rs.50,000/- Dated 03- Last GMP
Sheikhupura contains: 04-2015 (Photocopy inspection
Road, Faisalabad Alogliptin a sbenzoate attested by ABL conducted on
…… 12.5mg spinning mills 13-10-2017
Metformin HCl....1000mg Faisalabad) recommending
(Antidiabetic) 30‘s/ Rs. 650/- renewal of DML.
Drug Xpedia-Met 12.5mg/500mg Tablets
Name of Manufacturer M/s Saffron Pharmaceuticals Pvt Ltd., 19-Km, Sheikhupura Road, Faisalabad
Manufacturer of API Alogliptin benzoate: M/s Ruyuan HEC Pharm Co., Ltd. China
Metformin HCl: M/s IPCA Lab. Aurangabad, India
API Lot No. Alogliptin benzoate: AGLT II-201608101U
Metformin HCl: 17322ML 2RMI
Real Time: 30°C ± 2°C / 65% ± 5%RH
Frequency Real Time: 0,3,6,9 & 12 (months) Accelerated: 0,1,3 & 6 (months)

Batch No. T-002 T-003 T-004
Date of Initiation
No. of Batches 03
COA of API Yes
Approval of API by regulatory authority Firm has submitted copy of GMP certificate of Alogliptin
of country of origin or GMP certificate Benzoate for M/s Ruyuan HEC Pharm Co Ltd. China Issued by
of API manufacturer issued by Shaoguan Food and Drug Administration China valid upto 18-
regulatory authority of country of origin. 12-2019.
Aurangabad, India Issued by FDA Maharashtra State
Aurangabad dated 28-07-2014. Validity of certificate is not
evident for submitted document.
stability study and details of tests. Yes

Yes
sheets etc.
Documents confirming import of API Alogliptin Benzoate
etc. Firm has submitted copy of ADC attested invoice (Invoice#
PH60093) confirming import of 1.5 Kg Alogliptin from WIS
Metformin
the product.
Yes
Batches.
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of Xpedia
Met 12.5/500mg Tablets & Xpedia-Met 12.5mg/1000mg vide Letter no. Saf/018/426 & Saf/018/427
respectively dated 19-12-2018 and provided the following documents in conjunction with the checklist approved
by the Registration Board in its 278th Meeting:
(Date of submission: 21-12-2018 vide diary no. 43534 & 43535)
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
th
inspection for instant dosage form Saffaldi Tablet 400mg (Sofosbuvir), which was conducted on 8 th
conducted during last two years. January, 2018 and was presented in 279th meeting of Registration
Board held on 28th February-2nd March, 2018.
Following two observations were reported in the report:
 The firm has used two HPLC systems in the stability
studies of Saffaldi 400mg tablet details of which are as
under:
i. Schimadzu Lab solution (Equipment ID: QC-75)
ii. Schimadzu LC solution (Equipment ID: QC-101)
 Firm has demonstrated audit trail reports for the submitted
stability studies. The relevant log books for stability studies
were also verified.
 The firm has stability chambers for accelerated and real time
stability studies with uninterrupted power supply and digital
data loggers. Records of digital data logger for both chambers
were demonstrated.
2. Documents for the procurement of Alogliptin Benzoate
API with approval from DRAP (in Firm has submitted copy of ADC attested invoice (Invoice#
case of import). PH60093) confirming import of 1.5 Kg Alogliptin from WIS
Metformin
3. Documents for the procurement of Not submitted. Firm has stated that manufacturers have not
reference standard and impurity provided impurity.
standards.
4. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate of Alogliptin
certificate of API manufacturer Benzoate for M/s Ruyuan HEC Pharm Co Ltd. China Issued by
issued by regulatory authority of Shaoguan Food and Drug Administration China valid upto 18-12-
country of origin. 2019.

Aurangabad, India Issued by FDA Maharashtra State Aurangabad
dated 28-07-2014. Validity of certificate is not evident for
submitted document.
5. Mechanism for Vendor pre- Firm has submitted copy of SOPs for vendor qualification.
qualification.
6. Certificate of analysis of the API, The firm has submitted certificates of analysis for Alogliptin
reference standards and impurity Benzoate & Metformin HCl.COAs of reference standard has been
standards. submitted while COA of any impurity has not been submitted.
7. Documents for the procurement of The firm has submitted photocopy of Purchase Order/Invoices for
excipients used in product the procurement of excipients used in product development
development?
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified staff (2
product development with relevant members) involved in Research & Development department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of following documents
development & stability testing of a. SOP for Pharmaceutical Product Development protocol.
trial batches. b. SOP for conducting stability studies.

stability studies of Xpedia-Met 12.5/500mg &Xpedia-Met
12.5/1000mg tablets such as.
Xpedia-Met 12.5/500mg tablets
T-002 07-2017 1500 Tablets
T-003 09-2017 1500 Tablets
T-004 09-2017 1500 Tablets
T-002 10-2017 1500 Tablets
T-003 12-2017 1500 Tablets
T-004 12-2017 1500 Tablets
11. Record of remaining quantities of The firm has submitted sample utilization record for three trial
stability batches. batches kept in stability chambers long term stability studies.

Batch No. Remaining
quantities
T-002 254 Tablets
T-003 280 Tablets
T-004 192 Tablets
Batch No. Remaining
quantities
T-002 330 Tablets
T-003 330 Tablets
T-004 280 Tablets
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital printouts for Real
temperature and humidity monitoring Time conditions only and that also does not cover the complete
of stability chambers (real time and period of stability studies since submitted data is for January 2018
accelerated) & February 2018 only.
13. Method used for analysis of API  The firm has submitted photocopy of raw material
along with COA. specifications, raw material testing procedures, COA and for
both Alogliptin benzoate & Metformin HCl along with
relevant analytical record.
complete record of testing of stability Procedure for Xpedia-Met 12.5/500mg tablets & Xpedia-Met
batches (i.e. chromatograms, lab 12.5/500mg tablets along with Stability Study Report of stability
reports, raw data sheets etc.) batches, chromatograms, lab reports, raw data sheets etc.
15. Reports of stability studies of API Alogliptin benzoate: The firm has submitted stability studies
from manufacturer. reports for both Accelerated (40°C ± 2°C / 75% ± 5%RH) for 6
months & Long term (30°C ± 2°C / 65% ± 5%RH) conditions for
24 months from manufacturer.
Metformin HCl:
The firm has submitted stability studies reports for both
Accelerated (40°C ± 2°C / 75% ± 5%RH) for 6 months & Long
manufacturer.
for all excipients used in product development of Xpedia-Met
tablets.

17. Drug-excipients compatibility Firm has submitted drug excipient compatibility studies by using
studies. binary mixtures of both APIs with all excipients and determination
of %age content by HPLC analysis
18. Record of comparative dissolution  Firm has submitted Comparative Dissolution Profile protocol
data. & reports. The details of reference product & Sample product
are as follows:
product Genix
Brand name Vipdomet Xpedia-Met
12.5/500mg tablet 12.5/500mg tablet
Batch No. 1393181 T-002
following mediums:
a. pH 1.2 buffer
b. pH 4.5 Acetate buffer
c. pH 6.8 Phosphate buffer
 Firm has submitted results for the CDP study showing
acceptable f2 values.
on product testing.
 Dissolution test mentioned in submitted Standard Analytical Procedure and Xpedia-Met 12.5/500mg tablet
(Document# QC/AP/FG/198) & of Xpedia-Met 12.5/1000mg tablet (Document# QC/AP/FG/208) differs
from USFDA recommended method in terms of time, since USFDA has recommended 30 minutes whereas
firm has applied 45 minutes.
 The firm has submitted photocopies of digital printouts for Real Time conditions only and that also does not
cover the complete period of stability studies since submitted data is for January 2018 & February 2018
only.
 Dissolution test mentioned in submitted Standard Analytical Procedure and Xpedia-Met 12.5/500mg
tablet (Document# QC/AP/FG/198) & of Xpedia-Met 12.5/1000mg tablet (Document# QC/AP/FG/208)
differs from USFDA recommended method in terms of time, since USFDA has recommended 30
minutes whereas firm has applied 45 minutes.
 The firm has submitted photocopies of digital printouts for Real Time conditions only and that also
does not cover the complete period of stability studies since submitted data is for January 2018 &
February 2018 only
Sr Name & Address Brand Name Type of Form, International REMARK
.# of Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local S
Applicant Dosage Form + Strength), Fee (including Availability (IF ANY)
Composition, differential fee), GMP Inspection
Pharmacological Group, Demanded Price / Report Date &
Finished Product Pack size Remarks
Specification
410. "M/s Scotmann Velocity tablets 60mg Form-5D Dy. No Approved by
Pharmaceuticals. "Each film coated tablet 42034 dated 07-12- USFDA
5-D, I-10/3, contains: 2018 Rs.20,000/- Anplag by M/s
Industrial Area, Ticagrelor.…60mg" Dated 07-12-2018 PharmEvo
Islamabad" (Antithrombotic drugs) 2x10‘s, 6 x 10‘s, 3 x GMP certificate
10‘s, 4x7‘s, 2x14‘s, issued on the basis
28‘s: As per SRO of inspection
conducted on 10-
10-2018 & 17-10-
2018.

Drug Velocity Tablets 60mg
Name of Manufacturer M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad
Manufacturer of API M/s Glenmark Pharmaceuticals Ltd, Z/103/I, Dahej SEZ Part-II, Opposite to
GCPTTL, Dahej Gujrat
API Lot No. 82160976
Description of Pack
Alu-Alu blister pack
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. Trial#01 Trial#02 Trial#03
Batch Size 1500 Tablet 1500 Tablet 1500 Tablet
No. of Batches 03
Sr Documents To Be Provided Status
.#
i. COA of API Yes
ii. Approval of API by regulatory authority
of country of origin or GMP certificate Firm has submitted copy of GMP certificate (No. 16061165)
of API manufacturer issued by dated 27-06-2016 issued by Food and Drugs control
regulatory authority of country of origin. Administration Gujrat State India.
iii. Protocols followed for conduction of

Yes
iv. Data of 03 batches will be supported by
Yes
sheets etc.
v. Documents confirming import of API Firm has submitted following
etc.  Copy of form 6 dated 16-05-2017, confirming license to
import of M/s Scotmann with M/s Glenmark Pharmaceuticals
Ltd, Z/103/I, Dahej SEZ Part-II, Opposite to GCPTTL, Dahej
Gujrat
 ADC attested commercial invoice confirming import of
1.125Kg Ticagrelor
vi. All provided documents will be attested
vii. Commitment to continue real time
the product.
viii. Commitment to follow Drug
Yes

Batches.

Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of
Velocity 60mg tablets vide Letter no. SM/DRA/DRAP/0119/490 dated 17-01-2019 and provided the following
documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
inspection for instant dosage form Dascot Tablet 30mg (Daclatasvir), which was conducted on 26 th
Board held on 29-31st January, 2017.
i. The HPLC software is 21CFR Compliant.
ii. Firm has shown all Audit trail reports.
chambers. Data Loggers are also placed in stability chambers
for monitoring
2. Documents for the procurement of Firm has submitted following
API with approval from DRAP (in  Copy of form 6 dated 16-05-2017, confirming license to import
case of import). of M/s Scotmann with M/s Glenmark Pharmaceuticals Ltd,
Z/103/I, Dahej SEZ Part-II, Opposite to GCPTTL, Dahej Gujrat
 ADC attested commercial invoice confirming import of 1.125Kg
Ticagrelor
3. Documents for the procurement of Firm has submitted copy of invoice for 500mg Ticagrelor along
reference standard and impurity with impurity standard A (50mg), B (7.5mg) and C (7.5mg)
standards.
4. Approval of API/ DML/GMP
Firm has submitted copy of GMP certificate (No. 1808965) dated
certificate of API manufacturer
09-08-2018 issued by Food and Drugs control Administration
issued by regulatory authority of
Gujrat State India, valid upto 09-08-2018.
country of origin.
5. Mechanism for Vendor pre- Firm has submitted copy of vendor evaluation form and vendor
qualification evaluation report
6. Certificate of analysis of the API, Firm has submitted COA of API and reference standard.
reference standards and impurity
standards
7. Documents for the procurement of Firm has submitted documents for procurement of excipients.
development?
8. List of qualified staff involved in Firm has provided list of technical staff of product development
product development with relevant section.
experience.
Production Data
9. Authorized Protocols/SOP for the Firm has submitted authorized protocols/SOPs for the development
development & stability testing of & testing of trial batches.
trial batches.
10. Complete batch manufacturing Firm has provided Batch Manufacturing Record for all the three
record of three stability batches. batches

11. Record of remaining quantities of Firm has provided following remaining quantities for each batch
stability batches. for long term stability studies:
 Trial#01: 176 Tablets
QA / QC DATA
12. Record of Digital data logger for Firm has submitted record of Digital data logger for temperature
temperature and humidity and humidity monitoring of stability chambers.
monitoring of stability chambers
(real time and accelerated)
13. Method used for analysis of API Firm has submitted COA and method of analysis of API.
along with COA.
14. Method used for analysis of FPP & Firm has submitted method of analysis of FPP and complete record
complete record of testing of of testing of stability batches along with chromatograms.
stability batches (i.e.
chromatograms, lab reports, raw
data sheets etc.)
15. Reports of stability studies of API Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH)
from manufacturer. stability studies & long term (30°C ± 2°C & 65±5%RH) stability
studies reports of three batches.
16. Analysis reports for excipients Firm has submitted analysis reports for all excipients used.
used.
17. Drug-excipients compatibility Firm has submitted that their formulation is as per innovator and
studies. provided various references for the formulation compatibility
18. Record of comparative dissolution  Firm has submitted data of comparative dissolution profile
data. against reference product Brilinta tablets (Lot# KM0394) at pH
1.2, 4.5 and 6.8.and calculated values of f1 and f2 which were
within accepted range
19. Compliance Record of HPLC Firm has submitted audit trail reports for HPLC analysis for all the
software 21CFR & audit trail three batches.
reports on product testing.
Decision: Registration Board decided to approve registration of ―Velocity tablets 60mg (Ticagrelor) by
M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad". Manufacturer will place first
three production batches of the product on long term stability studies throughout proposed shelf life and
on accelerated studies for six months.
Address of (Proprietary Name + Initial Diary & Availability / Local (IF ANY)
Manufacturer / Dosage Form + Strength), Date, Fee Availability
Applicant Composition, (including
Finished Product Demanded Price / Report Date &
Specification Pack size Remarks
411. M/s Ferozsons Sitagen-M 100/1000 Form-5 Approved by USFDA
Labs, Tablets Dy. No: 3448 Last GMP inspection
Amangarh, Each film coated tablet Dated. 25-01-2019 conducted on 10-01-
Nowshera. contains:- Rs.20,000/- dated 2018recommending
Sitagliptin phosphate 22-01-2019 issuance of GMP
monohydrate eq. to As per DRAP certificate
Sitagliptin (Immediate policy
release) .……... 100mg
Metformin HCl (sustained
release) .…… 1000mg
(Anti-diabetic)
th
Drug Sitagen-M 100/1000 Tablets
Name of Manufacturer M/s Ferozsons Labs, Amangarh, Nowshera.
Manufacturer of API Sitagliptin phosphate monohydrate: M/s Beijing Huikang Boyuan Chemical
Tech Co, Ltd – China.
Metformin HCl: M/s Ipca Laboratories Limited – India.
API Lot No. Sitagliptin: M-20170112-D02-M06-01
Metformin HCl: 17127ML2ARM
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Batch No. SMXR-004 SMXR-005 SMXR-006
No. of Batches 03
COA of API
Yes
Approval of API by regulatory Sitagliptin:

authority of country of origin or GMP  Copy of GMP Certificate issued on January 03, 2018 by Fuxin Food
certificate of API manufacturer and Drug Administration People‘s Republic of China in the name of
issued by regulatory authority of M/s Beijing Huikang Boyuan Chemical Tech Co, Ltd – China, has
country of origin. been submitted.
Metformin:
 Copy of GMP Certificate issued on August 28, 2018 by Food and
Drug Administration, M.S. Bandra (E), Mumbai, Maharashtra State,
India is submitted.
Yes
Data of 03 batches will be supported
by attested respective documents like
Yes
chromatograms, laboratory reports,
data sheets etc.
Documents confirming import of API The firm has submitted
etc.  Photocopy of ADC (Peshawar) attested commercial invoice for
300kg Sitagliptin phosphate monohydrate invoice # HN170727-C
dated: 12-08-2017, lot No. M-20170112-D02-M06-01 from Beijing
Huikang Boyuan Chemical Tech Co, Ltd – China
 Photocopy of ADC (Peshawar) attested commercial invoice for
1000kg Metformin HCl invoice # MEG1718/1631990 dated:
12/02/2018 lot No. 17127ML2ARM from M/s Ipca Laboratories
Limited – India.
All provided documents will be
Yes
attested (name, sign and stamp) for

ensuring authenticity of data /
documents.
stability study till assigned shelf life Yes
of the product.
Yes
Batches.

Sitagen-M XR Tablets 100/1000 mg vide Letter no. PDFLL-657212091, dated 12-02-2019 and provided the
Name & Address of Manufacturer / Applicant
Sr. # Question Submission
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product ―INVICTA
inspection for instant dosage TABLETS‖ (Sofosbuvir 400mg and Velpatasvir 100mg), which was
form conducted during last conducted on 16-March 2018 and was presented in 281st meeting of
two years. Registration board. Registration Board decided to approve registration of
―INVICTA TABLETS‖ by M/s. Ferozsons Laboratories Limited.
According to the report following points were confirmed
 HPLC is 21 CFR compliant
 Audit trails of the test reports were available.
 Related manufacturing area equipment‘s personals and utilities
were found GMP compliant.
2. Documents for the The firm has submitted
procurement of API with  Photocopy of ADC (Peshawar) attested commercial invoice for
approval from DRAP (in case 300kg Sitagliptin phosphate monohydrate invoice # HN170727-C
of import). dated: 12-08-2017, lot No. M-20170112-D02-M06-01 from Beijing
Limited – India.
3. Documents for the  Copy of NOC from DRAP Peshawar along with invoice for import
procurement of reference of Sitagliptin Phosphate USP Reference Standard has been
standard and impurity submitted.
standards.  Copy of P.O and invoice for import of Metformin HCl USP
Reference Standard has been submitted.
 No relevant document for procurement of impurity standards has
been submitted.
4. Approval of API/ DML/GMP Sitagliptin:
certificate of API  Copy of GMP Certificate issued on January 03, 2018 by Fuxin Food
manufacturer issued by and Drug Administration People‘s Republic of China in the name of
regulatory authority of M/s Beijing Huikang Boyuan Chemical Tech Co, Ltd – China, has
country of origin. been submitted.
Metformin:

India is submitted.
5. Mechanism for Vendor pre- Firm has submitted SOP ―Procedure for induction of new vendor‖
qualification
6. Certificate of analysis of the  Sitagliptin
API, reference standards and Photocopy of COA of Batch No. M-20170112-D02-M06-01 issued from
impurity standards Beijing Huikang Boyuan Chemical Tech Co, Ltd – China
 Metformin hydrochloride
Photocopy of COA of Batch No. 17127ML2ARM issued from M/s Ipca
Laboratories Limited – India is submitted.
 Reference standards:
The firm has submitted the copy of COA‘s of USP reference standard for
Sitagliptin phosphate and Metformin HCl.
7. Documents for the Firm has submitted documents for procurement of excipients used in
procurement of excipients product development.
used in product
development?
8. List of qualified staff Firm has submitted list of 10 qualified persons
involved in product
development with relevant
experience.
Production Data
9. Authorized Protocols/SOP The firm has submitted copy of SOP with the title ‗Product Development
for the development & Protocol of Sitagen-M XR Tablets (Sitagliptin + Metformin HCl)‘.
stability testing of trial Effective date 15-05-2018.
batches.
10. Complete batch Firm has provided complete batch manufacturing record of all the three
manufacturing record of three batches
stability batches. SITAGEN-M XR Tablets 100mg/1000mg
Batch No. Bach size Mfg. Started Mfg. Completed
SMXR-004 1200 Tabs 20-06-2018 22-06-2018
SMXR-005 1200 Tabs 20-06-2018 23-06-2018
SMXR-006 1200 Tabs 21-06-2018 24-06-2018
11. Record of remaining Firm has submitted following remaining quantities:
quantities of stability batches. Sitagen-M XR Tablet 100mg/1000mg ; Stability Pack Size : 2 x 5‘s)
 SMXR-004: Batch Size : 1200 Tablets
Yield 650 Tablets (65 Packs),
26 packs (Stability samples) For Accelerated (11 Packs) For Long Term
(15 Packs)
39 packs (PD reference samples)
Yield 630 Tablets (63 Packs)
26 packs (Stability samples For Accelerated (11 Packs) For Long Term
(15 Packs)
Yield 660 Tablets (66 Packs).
(15 Packs)
40 packs (PD reference sample)
QA/QC DATA
12. Record of Digital data logger Firm has submitted record of digital data logger for temperature and
for temperature and humidity humidity monitoring control for the complete stability period from
monitoring of stability 11-05-2018 to 11-01-2019.
chambers (real time and

accelerated)
13. Method used for analysis of Firm has provided the method used for analysis of API along with its
API along with COA. certificate of analysis
14. Method used for analysis of Firm has provided method used for analysis of FPP and complete record
FPP & complete record of of testing of stability batches including chromatograms, lab reports and
testing of stability batches raw data sheets are submitted with 06 months stability data (Accelerated
(i.e. chromatograms, lab & Real Time).
15. Reports of stability studies of The firm has submitted copy of
API from manufacturer. accelerated, 06 Months (40°C ± 2°C & 75±5%RH) , long term, 24
Months (30°C ± 2°C & 65±5%RH) stability study reports of 03 batches
of Sitagliptin phosphate monohydrate from M/s Beijing Huikang Boyuan
Chemical Tech Co, Ltd – China
And
accelerated, 06 Months (40°C ± 2°C & 75±5%RH) , long term, 60
of Metformin HCl from M/s Ipca Laboratories Limited – India
16. Analysis reports for The firm has submitted copy of Manufacturer‘s COAs and Firm analysis
excipients used. reports for the excipients used in the applied formulation.
17. Drug-excipients The firm has not submitted Drug-excipients compatibility studies and has
compatibility studies. referred to the Innovator Product (Janumet XR Tablets).
18. Record of comparative Firm has submitted comparative dissolution profile with the reference
dissolution data. product Janumet XR Tablets manufactured by MSD International
GmbH.
Feature Reference Product of Ferozsons
Product Laboratories Limited
Brand Janumet XR Sitagen-M XR Tablets
name Tablets 100mg/1000mg
100mg/1000mg
Batch No. M045756 SMXR-004
Mfg. date 12-2016 06-2018
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR &
software 21CFR & audit trail audit trail reports

Address of (Proprietary Name Initial Diary & Date, Availability / (IF ANY)
Manufacturer / + Dosage Form + Fee (including Local
Applicant Strength), differential fee), Availability
Composition, Demanded Price /
Pharmacological Pack size GMP Inspection
Group, Report Date &
Finished Product Remarks
Specification
412. M/s Ferozsons Sitagen-M 50/1000 Form-5 Approved by The applied
Labs, Tablets Dy. No: 125 USFDA formulation was
Amangarh, Each film coated Dated. 02-03- Last GMP previously
Nowshera. tablet contains:- 2015 inspection approved in 276th
Sitagliptin Rs.20,000/- conducted on 10- meeting of
phosphate 14‘s,28‘s,30‘s 01- Registration Board
monohydrate eq. to As per SRO 2018recommendi in the name of M/s
Sitagliptin ng issuance of Ferozsons as
(Immediate release) GMP certificate bilayer tablets.
.……... 50mg Now firm has
Metformin HCl requested to change
(sustained release) the formulation as
.…… 1000mg per reference
(Anti-diabetic) product and has
submitted new
Form 5 and
relevant stability
data. Firm has also
submitted fee of
Rs. 5,000/- vide
deposit slip#
0788903 dated 25-
01-2019.
Drug Sitagen-M 50/1000 Tablets
Name of Manufacturer M/s Ferozsons Labs, Amangarh, Nowshera.

Manufacturer of API Sitagliptin phosphate monohydrate: M/s Beijing Huikang Boyuan Chemical
Tech Co, Ltd – China.
Metformin HCl: M/s Ipca Laboratories Limited – India.
API Lot No. Sitagliptin: M-20170112-D02-M06-01
Metformin HCl: 17127ML2ARM
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Batch No. SMXR-001 SMXR-002 SMXR-003
No. of Batches 03
COA of API
Yes
Approval of API by regulatory Sitagliptin:

authority of country of origin or GMP  Copy of GMP Certificate issued on January 03, 2018 by Fuxin
certificate of API manufacturer issued Food and Drug Administration People‘s Republic of China in the
by regulatory authority of country of name of M/s Beijing Huikang Boyuan Chemical Tech Co, Ltd –
origin. China, has been submitted.
Metformin:
Drug Administration, M.S. Bandra (E), Mumbai, Maharashtra
State, India is submitted.
Yes
Data of 03 batches will be supported Yes

by attested respective documents like
chromatograms, laboratory reports,
data sheets etc.
Documents confirming import of API The firm has submitted
etc.  Photocopy of ADC (Peshawar) attested commercial invoice for
300kg Sitagliptin phosphate monohydrate invoice # HN170727-C
dated: 12-08-2017, lot No. M-20170112-D02-M06-01 from
Beijing Huikang Boyuan Chemical Tech Co, Ltd – China
Limited – India.
All provided documents will be
Yes
documents.
the product.
Yes
Batches.

Sitagen-M XR Tablets 50/1000 mg vide Letter no. PDFLL-658212091, dated 12-02-2019 and provided the
Sr. Question Submission
#
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product ―INVICTA
inspection for instant dosage TABLETS‖ (Sofosbuvir 400mg and Velpatasvir 100mg), which was
form conducted during last two conducted on 16-March 2018 and was presented in 281st meeting of
years. Registration board. Registration Board decided to approve registration of
―INVICTA TABLETS‖ by M/s. Ferozsons Laboratories Limited.
According to the report following points were confirmed
2. Documents for the procurement The firm has submitted

of API with approval from  Photocopy of ADC (Peshawar) attested commercial invoice for
DRAP (in case of import). 300kg Sitagliptin phosphate monohydrate invoice # HN170727-C
dated: 12-08-2017, lot No. M-20170112-D02-M06-01 from Beijing
Limited – India.

3. Documents for the procurement  Copy of NOC from DRAP Peshawar along with invoice for import
of reference standard and of Sitagliptin Phosphate USP Reference Standard has been
impurity standards. submitted.
 Copy of P.O and invoice for import of Metformin HCl USP
Reference Standard has been submitted.
 No relevant document for procurement of impurity standards has
been submitted.
4. Approval of API/ DML/GMP Sitagliptin:
certificate of API manufacturer  Copy of GMP Certificate issued on January 03, 2018 by Fuxin Food
issued by regulatory authority of and Drug Administration People‘s Republic of China in the name of
country of origin. M/s Beijing Huikang Boyuan Chemical Tech Co, Ltd – China, has
been submitted.
Metformin:
India is submitted.
qualification
6. Certificate of analysis of the  Sitagliptin
API, reference standards and Photocopy of COA of Batch No. M-20170112-D02-M06-01 issued from
impurity standards Beijing Huikang Boyuan Chemical Tech Co, Ltd – China
 Metformin hydrochloride
Photocopy of COA of Batch No. 17127ML2ARM issued from M/s Ipca
Laboratories Limited – India is submitted.
 Reference standards:
The firm has submitted the copy of COA‘s of USP reference standard for
Sitagliptin phosphate and Metformin HCl.
7. Documents for the procurement Firm has submitted documents for procurement of excipients used in
of excipients used in product product development.
development?
8. List of qualified staff involved in Firm has submitted list of 10 qualified persons
product development with
relevant experience.
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of SOP with the title ‗Product Development
the development & stability Protocol of Sitagen-M XR Tablets (Sitagliptin + Metformin HCl)‘ and
testing of trial batches. Stability protocols.
Effective date 05-01-2018.
10. Complete batch manufacturing  Firm has provided complete batch manufacturing record of all the
record of three stability batches. three batches
SITAGEN-M XR Tablets 50mg/1000mg
SMXR-001 1200 Tabs 21-04-2018 23-04-2018

SMXR-002 1200 Tabs 21-04-2018 24-04-2018
SMXR-003 1200 Tabs 21-04-2018 25-04-2018
11. Record of remaining quantities Firm has submitted following remaining quantities:
of stability batches. Sitagen-M XR Tablet 50mg/1000mg ; Stability Pack Size : 2 x 5‘s)
26 packs (Stability samples) For Accelerated (11 Packs) For Long Term
(15 Packs)

(15 Packs)
(15 Packs)
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of digital data logger for temperature and
temperature and humidity humidity monitoring control for the complete stability period from
monitoring of stability chambers 11-05-2018 to 11-01-2019.
13. Method used for analysis of API Firm has provided the method used for analysis of APIs along with their
along with COA. certificate of analysis.
14. Method used for analysis of FPP  Firm has provided method used for analysis of FPP and complete
& complete record of testing of record of testing of stability batches including chromatograms, lab
stability batches (i.e. reports and raw data sheets are submitted with 06 months stability
chromatograms, lab reports, raw data (Accelerated & Real Time).
data sheets etc.)
15. Reports of stability studies of The firm has submitted copy of accelerated, 06 Months (40°C ± 2°C &
API from manufacturer. 75±5%RH) , long term, 24 Months (30°C ± 2°C & 65±5%RH) stability
study reports of 03 batches of Sitagliptin phosphate monohydrate from
M/s Beijing Huikang Boyuan Chemical Tech Co, Ltd – China
And
Accelerated, 06 Months (40°C ± 2°C & 75±5%RH) , long term, 60
of Metformin HCl from M/s Ipca Laboratories Limited – India
16. Analysis reports for excipients The firm has submitted copy of Manufacturer‘s COAs and Firm analysis
used. reports for the excipients used in the applied formulation.
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility studies and has
studies. referred to the Innovator Product (Janumet XR Tablets).
dissolution data. product Janumet XR Tablets manufactured by MSD International
GmbH.
Feature
Reference Product of Ferozsons
Brand name Janumet XR Sitagen-M XR Tablets
Tablets 50mg/1000mg
50mg/1000mg
Batch No. M040718 SMXR-001
Mfg. date 12-2016 04-2018
Evaluation by PEC:
 Dissolution method submitted by firm differs from that recommended by USFDA detailed as under:
Parameter USFDA Firm‘s method
recommendation
Time (Sitagliptin) 30 minutes 45 minutes
Apparatus Paddle Basket
RPM 75 100

 In contrary to reference product wherein extended release metformin core has been prepared by
incorporating matrix forming polymer in the metformin core, whereas firm has applied an extended release
coating over the metformin core. Clarification/justification shall be submitted for this variation.
 Upon communication of above observations vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-II) dated
04-04-2019, firm has responded as under:
 Firm has submitted analytical record for performance of dissolution data as per USFDA recommendations
for all the three stability batches of both strengths, wherein the results of Sitagliptin are more than 90% in
30 minutes. Moreover firm has committed that in future we will follow USFDA recommendations for
testing the dissolution of our products placed on real time stability.
 Firm has referred to literature of various formulations of Metformin Extended release tablets approved by
USFDA, wherein an extended release coating over the metformin core has been applied and this technology
has been named as ―osmotic pump technology system‖.
Decision: Registration Board was apprised of the decision of 151 st meeting of Appellate Board regarding
Sovel 400/100mg Tablet (Sofosbuvir/Velpatasvir) of M/s Indus Pharmaceuticals, Karachi, wherein Board
agreed with the submission made by the firm and allowed the appeal regarding GMP status of their
supplier of Sofosbuvir i.e. M/s Bejing Huikang Boyuan Chemical Co., Ltd. Subsequently Registation
Board in its 288th meeting approved the said product of M/s Indus Pharmaceuticals, Karachi.
Hence considering the baove cited reference and submitted stability studies data decided to approve
Sitagen-M 100/1000 Tablets of M/s Ferozsons Labs, Amangarh, Nowshera. Manufacturer will place first
three production batches of the product on long term stability studies throughout proposed shelf life and
The Board also approved the change of formulation of Sitagen –M 50/1000 tablets as per reference
product.
Sr. Name & Brand Name Type of Form, International REMARKS

# Address of (Proprietary Name + Initial Diary & Date, Availability / (IF ANY)
Manufacturer / Dosage Form + Strength), Fee (including Local
Applicant Composition, differential fee), Availability
413. M/s Hilton Hilfo-B 25 mg Tablet Form 5-D Approved by
Pharma (Pvt.) Each film coated tablet Diary No. 3666 dated USFDA
Ltd. Karachi contains: 23-12-2016 Not applicable.
Tenofovir Alafenamide Rs.50,000/- dated 23- GMP Certificate
fumarate equivalent to 25 12-2016 issued on 19-02-
mg Tenofovir 30‘s As per DPC 2018.
Alafenamide
(Anti-viral)
Drug Hilfo-B 25 mg Tablet
Name of Manufacturer M/s Hilton Pharma (Pvt.) Ltd. Karachi
Manufacturer of API M/s YiChang HEC ChangJiang Pharmaceutical Co., Ltd, Hubei Province, China
API Lot No. HCS171610-01
Real Time: 30°C ± 2°C / 65% ± 5%RH
Frequency Real Time: 0,3 & 6 (months) Accelerated: 0,3 & 6 (months)
Batch No. HFB-281307-4 HFB-281307-5 HFB-281307-6
Batch Size 4,500 Tablets 4,500 Tablets 4,500 Tablets
th
No. of Batches 03
COA of API Yes
Approval of API by regulatory authority The firm has provided copy of Certificate of GMP compliance issued
of country of origin or GMP certificate to M/s Jiangxi Synergy Pharmaceutical Co., Ltd. by Germany valid
of API manufacturer issued by Up to 27-11-2018
regulatory authority of country of origin.
Yes
Yes
sheets etc.
Documents confirming import of API Commercial Invoices signed & stamped by ADC DRAP, Karachi
etc. dated 28-03-2017 has been attached.

the product.
Yes
Batches.

Now the firm has requested for Exemption from On-site Investigation of their submitted stability data of Hilfo-B
25mg tablets vide Letter no. AQS/SK/191104-01, dated 11-04-2018 and provided the following documents in
conjunction with the checklist approved by the Registration Board in its 278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their
inspection for instant dosage form product ―HILVEL 400mg + 100mg (Sofosbuvir +
conducted during last two years. Velpatasvir)‖, which was conducted on 14th December,
2017 and was presented in 277th meeting of Registration Board
held on 27-29th December, 2017.
Registration Board decided to approve registration of
―HILVEL 400mg / 100mg (Sofosbuvir + Velpatasvir‖ by
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer will place
first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six
months.
i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of Hilvel Tablets
400mg+100mg is available.
chamber. Chamber are controlled and monitored through
software having alarm system for alerts as well.
2. Documents for the procurement of Copy of Form 6 signed & stamped by ADC DRAP, Karachi dated
API with approval from DRAP (in 03-01-2018 for the import of Tenofovir Alfenamide Fumarate
case of import). has been submitted.
Batch No. Invoice No. Quantity Imported
Not mentioned WIS1700069 300gm
on invoice
3. Documents for the procurement of Firm has submitted a letter from M/s Yichang HEC Changjiang
reference standard and impurity Pharmaceutical Co., Ltd., China declaring the submission of
standards. working standard & impurity standards (A, PMPA) for Tenofovir
Alfenamide Fumarate by hand through M/s Wis International Pvt.
Ltd to M/s Hilton Pharma (Pvt.) Ltd.
4. Approval of API/ DML/GMP  The firm has provided copy of Manufacturing License for
certificate of API manufacturer issued Pharmaceutical (Certificate # 20160013) issued to M/s
by regulatory authority of country of YiChang HEC ChangJiang Pharmaceutical Co., Ltd, Hubei
origin. Province, China by Hubeii Food & Drug Administration valid
Up to 31-12-2020.
 The GMP certificate mentioning the name of API i.e.,
Tenofovir Alfenamide, has been issued by Yichang Food and
Drug Administration, which is not the relevant regulatory
authority.
5. Mechanism for Vendor pre-  The firm has submitted photocopy of ―SOP for Selection of
qualification manufacturer for API/Excipient and Procurement Procedure‖,
SOP No: PDV-FM-068 with effective date 02-03-2018.
Version no: 01
 Copy of ―Vendor‘s Audit form‖ filled for M/s YiChang HEC
ChangJiang Pharmaceutical Co., Ltd, Hubei Province, China,
dated 20-03-2019
6. Certificate of analysis of the API,  The firm has submitted certificate of analysis for API (Batch#
reference standards and impurity HCS171610-01), working standard and impurity standard for
standards Tenofovir Alfenamide Fumarate.
 The Qualification report of reference standards & Impurity
standards have been submitted form HEC R&D center.
7. Documents for the procurement of The firm has submitted photocopy of Purchase Order/Invoices for
excipients used in product the procurement of excipients used in product development
development?
8. List of qualified staff involved in The firm has submitted photocopy of List of qualified staff
product development with relevant involved in product development & regulatory affairs comprising
experience. of 18 members.
Production Data
9. Authorized Protocols/SOP for the  The firm has submitted photocopy of Development Protocol
development & stability testing of for Lab scale batch manufacturing of Hilfo-B 25mg Film
trial batches. coated tablets.
 Project code # HPL/07/18/HFB
 Issued on July, 2018
 The SOP mentions the details of master formulation &
manufacturing method for both products. Copies of stability
protocols have also been submitted for both products.

stability studies of Hilfo-B 25mg tablets, such as.
Hilfo-B 25mg Tablet
HFB-281307-4 09-08-2018 4,500 Tablets
HFB-281307-5 09-08-2018 4,500 Tablets
HFB-281307-6 09-08-2018 4,500 Tablets
Hilfo-B 25mg Tablet
Batch No. Remaining Quantity
MRG-266201-10 130 Tablets
QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital printouts of Real
temperature and humidity monitoring Time and Accelerated Conditions for complete stability studies of
of stability chambers (real time and applied formulations.
accelerated)
13. Method used for analysis of API  The firm has submitted photocopy of raw material
along with COA. specifications, raw material testing procedures and report for
Hilfo-B (batch #.HCS171610-01)
 Relevant chromatograms, FTIR spectrum, lab reports, raw
data sheets & COAs have been submitted.
complete record of testing of stability Procedure PD-FPS/136/00) for Hilfo-B 25 mg tablets along with
batches (i.e. chromatograms, lab Stability Study Report of stability batches & chromatograms, lab
reports, raw data sheets etc.) reports, raw data sheets etc.
15. Reports of stability studies of API The firm has submitted stability studies reports on Tenofovir
from manufacturer. Alfenamide fumarate from API manufacturer for both Accelerated
(25°C ± 2°C / 60% ± 5%RH)& Long term (5°C ± 3°C) conditions.
for all excipients used in product development of Hilfo-B tablets.
17. Drug-excipients compatibility studies.  The firm has not performed Drug-excipients compatibility
studies and stated that the qualitative composition of their
product is similar to that of innovator‘s product tablet and also
stability studies have not shown any incompatibility or
significant degradation.
18. Record of comparative dissolution  Firm has submitted F2 factor protocol & reports. The details
data. of reference product & Sample product are as follows:
Hilfo-B 25mg Tablet
product Hilton
Brand name Tenofomide Hilfo-B 25mg
25mg tablet tablet
Batch No. 001FB1 HFB-281407-5
Expiry date 01-2021 --
following mediums:
i. pH 1.2 HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
 As per submitted reports both reference and trial product

released more than 85% at all three dissolution mediums.
 Firm has submitted UV spectrums and raw data sheets for the
CDP study.
on product testing.
 Firm has also submitted report from FID, Karachi for verification of storage facility concluding as under:
―The above facility based on its suitability is recommended for the storage of all types of bio-tech vaccines
required to be stored at 2-8oC.
 Firm has also submitted a declaration from M/s YiChang HEC ChangJiang Pharmaceutical Co., Ltd, Hubei
Province, China stating that the company name, Yichang Dongyang Chingjiang Pharm Co., Ltd on Chinese
cFDA website is the exactly same company with us. The translation issue causes the difference that
Dongyang is our Chinese name pronunciation.
Decision: Registration Board decided to approve registration of ―Hilfo -B 25 mg Tablet (Tenofovir

Alafenamide fumarate equivalent to 25 mg) by M/s Hilton Pharma (Pvt.) Ltd. Karachi.Manufacturer will
place first three production batches of the product on long term stability studies throughout proposed
shelf life and on accelerated studies for six months.
Sr# Name & Address Brand Name Type of Form, International Availability / Local
of Manufacturer / (Proprietary Name + Initial Diary & Date, Availability
Strength), Composition, differential fee), GMP Inspection Report Date &
Pharmacological Demanded Price / Remarks
Group, Pack size
Finished Product
Specification
414. M/s Scilife Teno-Alf Tablet Form 5-D Vemlidy Tablets by Gilead
Pharma (Pvt.) Ltd, Each film coated tablet Dy. No. 1129 Sciences (USFDA Approved)
Plot FD-57/58-A2 contains: 02-5-2017 GMP inspection report dated:
Korangi Creek Tenofovir alafenamide PKR 50,000/- 10-07-2018 concluding acceptable
Industrial Park , fumarate eq to (02-5-2017) level of compliance.
Karachi - Tenofovir 10‘s, 30‘s
alafenamide……25mg Alu-Alu
Anti-Viral Blister
(In house specification) As per SRO
The firm has submitted stability study data along with required documents as per checklist approved in
276th meeting of Registration Board for exemption from ―On site investigation of submitted stability
data‖. Details of submitted data are as under:
(Dy.# 34588 dated 18-10-2018)
Drug Teno- Alf Tablet 25mg
Name of Manufacturer M/s Scilife Pharma (Pvt.) Ltd, Plot FD-57/58-A2
Korangi Creek Industrial Park , Karachi
Manufacturer of API M/s Shanghai Desano Chemical Pharmaceutical Co., China
API Lot No. DBH2581-B15A-170904
Description of Pack
Alu Alu blister with Unit Carton
Time Period Real time: 0,3,6 months Accelerated: 0,3,6 months
Frequency Accelerated: 0,3,6,9,12,18,24,36 months Real Time: 0,3,6 months
Batch No. 006B18 007B18 008B18
No. of Batches 3
Date of Submission Dy.# 34588 dated 18-10-2018
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP certificate
country of origin or GMP certificate of API Certificate No. : SH20170006
manufacturer issued by regulatory authority of Certifying Authority: China Food and Drug
country of origin. Administration.
The mentioned bulk drug on GMP certificate is
Efavirenz whereas, you have applied for Tenofovir
Alafenamide.
study and details of tests. Stability Study Protocol Number: P-FSB-105/00.
4. Data of 03 batches will be supported by Registration Board in its 276th Meeting decided that
attested respective documents like following time points for stability studies shall be
chromatograms, laboratory reports, data sheets adopted: Accelerated stability studies: 0, 1st , 2nd , 3rd ,
etc. 4th& 6th months whereas, you have conducted
accelerated Stability at following time points
Accelerated stability studies: 0,3rd& 6th months.
5. Documents confirming import of API etc. i. Copy of Form 6 (License to import drug for Clinical
Trial/Examination, Test or Analysis).
Supplier: M/s Shanghai Desano Chemical
Pharmaceutical Co., China
Quantity: 400g
ii. Copy of Commercial Invoice
Invoice No. : DL-Y-2017-0297
Batch No.: DBH2581-B15A-170904
Mfg Date: 18, Sep 2017
Exp. Date: 17, March 2019
Quantity: 400g
(Including working standard)
sign and stamp) for ensuring authenticity of
data / documents.
Yes
Yes
Rules, 1978.
Data for exemption from On-site investigation of submitted stability data
1. Reference of last onsite panel inspection for Registration Board approved ROMILAST (Roflumilast
instant dosage form conducted during last 500mcg) Tablets and TASVIR (Daclatasvir 60mg) Tablets
two years. in its 275th Meeting.
 Date of Inspection: 05th October, 2017 (Morning).
 The HPLC software is 21CFR Compliant as per record
of the firm.
 Audit trail on the testing reports (of ROMILAST and
TASVIR) can be made. Physically the related audit
trial was checked and found in order.
2. Documents for the procurement of API with iii. Copy of Form 6 (License to import drug for Clinical
approval from DRAP (in case of import). Trial/Examination, Test or Analysis).
Supplier: M/s Shanghai Desano Chemical Pharmaceutical
Co., China
Quantity: 400g
iv. Copy of Commercial Invoice
Invoice No. : DL-Y-2017-0297
Batch No.: DBH2581-B15A-170904
Mfg Date: 18, Sep 2017
Exp. Date: 17, March 2019
Quantity: 400g
(Including working standard)
The storage condition of API as per Manufacturer
requirement is 2-8°C.
3. Documents for the procurement of reference Material Batch No. Qty.

standard and impurity standards. Tenofovir Alafenamide 251A1601 100 mg
Fumarate Working Standard
Fumaric Acid Working BCBP2928V 50mg
Standard
Isomer 6, Isomer 7 161011-1-1 20mg
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate
API manufacturer issued by regulatory Certificate No. : SH20170006
authority of country of origin. Certifying Authority: China Food and Drug
Administration.
The mentioned bulk drug on GMP certificate is Efavirenz
whereas, you have applied for Tenofovir Alafenamide.
5. Mechanism for Vendor pre-qualification Not provided.
6. Certificate of analysis of the API, reference Firm has submitted certificate of analysis of working
standards and impurity standards standard and the impurity standards.
Material Batch No.
Tenofovir Alafenamide 251A1601
Fumarate Working Standard
Fumaric Acid Working BCBP2928V
Standard
Isomer 6, Isomer 7 161011-1-1
7. Documents for the procurement of excipients
used in product development?
MCC 102 Sigachi Industries, SH/17070968
Pashammailaram, India
Lactose Kerry Ingredients, 0001434878
Monohydrate Mumbai , India
Croscarmellose Gujarat Microwax 7111507225
Nandasan, India
Magnesium Nitika Pharmaceutical MGST1F252
Stearate Specialities, Nagpur
HPMC Shin Etsu DEAT291993
PEG 6000 Pan Asia Chemical 20150320
Corp
Titanium Cosmo Chemical K521-10120
Dioxide Korea
Talcum Powder Nitika Pharmaceutical PUTA2F163
Specialities, Nagpur
Yellow Ferric Bush Boake Allen 1280194001
Oxide Pakistan Pvt. Limited

8. List of qualified staff involved in product Name Designation Qualification Experie
development with relevant experience. nce
Jawad Sr. Manager B-Pharmacy 15 years
ahmed R&D
Syed M. Ast. Manager d-Pharmacy 07 years
Atif Abbas R&D
Adnan Asst. Manager M.Sc 07 years
Ahmed R&D analytical
Chemistry
Ghulam Sr. Executive BS Organic 04 years
Rasool R&D Chemistry
Ishaq Executive BS Analytical 03 years
Ahemd R&D Chemistry
Danish Officer R&D M.Sc Organic 01 years
Khalid Chemistry
Ashraf Sr. R&D Intermediate 13 years
Hussain Operatro
Production Data
9. Authorized Protocols/SOP for the Firm has provided authorized protocols for product
development & stability testing of trial development and stability testing of trial batches.
batches. Stability Study Protocol Number: P-FSB-105/00.
10. Complete batch manufacturing record of Firm has provided complete batch manufacturing record
three stability batches. and batch packaging record of all the three batches.
11. Record of remaining quantities of stability Firm has submitted following remaining quantities:
batches. Description 006B18 007B18 008B18
Theoretical Batch 2500 2500 2500
Size
Total produced 2297 2295 2302
Used for initial 50 50 50
testing
Kept on 350 350 350
30°C/RH75%
Kept on 100 100 100
40°C/RH75%
Remaining on 270 270 270
30° C/RH75%
Remaining on - - -
40° C/RH75%
Total used for 50 - -
CDP
Remaining 1747 1795 1802
quantities in R&D
QA/QC DATA
12. Record of Digital data logger for temperature Tabular record of Digital data logger for temperature and
and humidity monitoring of stability humidity monitoring of stability chambers has been
chambers (real time and accelerated). submitted.
13. Method used for analysis of API along with Firm has provided the method used for analysis of API
COA. along with its certificate of analysis but has not performed
related substances, test for enantiomer, residual solvent.
14. Method used for analysis of FPP & complete Firm has provided method used for analysis of FPP and
record of testing of stability batches (i.e. complete record of testing of stability batches including
chromatograms, lab reports, raw data sheets chromatograms, lab reports and raw data sheets.
etc.)

15. Reports of stability studies of API from Firm has submitted stability data of 3 batches of API
manufacturer. conducted at 2-8oC for long term but upto 24 months and
25oC for accelerated studies till 6 months.
Accelerated 25°C±2&60%±5
0,1,2,3,6 month
Term %
0,3,6,9,12,18 &
Long Term 5°C±3
24 month
16. Analysis reports for excipients used. Firm has submitted COA and analysis reports of all
excipients used in the study.
17. Drug-excipients compatibility studies. Firm has not performed drug excipient compatibility
studies as they claim their qualitative composition of
innovator and Teno-Alf is same. However, that is not the
case. The comparison of innovator product and Teno-Alf is
mentioned below:
Vemlidy Innovator Teno-Alf
Croscarmellose sodium Croscarmellose sodium
Microcrystalline cellulose Microcrystalline cellulose
Magnesium stearate Magnesium stearate
Lactose Monohydrate Lactose Monohydrate
Film Coat Film Coat

Polyvinyl alcohol HPMC
PEG PEG
Talc Talc
Titanium Dioxide Titanium Dioxide
Yellow Ferric Oxide Yellow Ferric Oxide
18. Record of comparative dissolution data. Firm has submitted comparative dissolution profile with
the reference product Vemlidy 25mg tablet at pH 1.2, pH
4.5 and pH 6.8.
19. Compliance Record of HPLC software
21CFR & audit trail reports on product
testing.
Evaluation by PEC:
Firm has submitted SOP for cleaning and usage of Refrigerator and freezer as evidence for requisite facility for
storage of API.
Decision: Registration Board decided to approve registration of ―Teno -Alf Tablet (Tenofovir
Alafenamide fumarate equivalent to 25 mg) by M/s Scilife Pharma (Pvt.) Ltd, Plot FD-57/58-A2Korangi
Creek Industrial Park , Karachi . Manufacturer will place first three production batches of the product
on long term stability studies throughout proposed shelf life and on accelerated studies for six months.
Sr. Name & Address of Brand Name Type of Form, International Availability
No. Manufacturer / (Proprietary Name + Initial Diary & Date, / Local Availability
Applicant Dosage Form + Strength), Fee (including
Composition, differential fee), GMP Inspection Report
Pharmacological Group, Demanded Price / Pack Date & Remarks
Finished Product size
Specification
415. M/s Scilife Pharma Sofolos Form 5-D Harvoni, FDA.
(Pvt.) Ltd Tablet Dairy No. 1271 Harvoni, Ferozsons,
Plot FD-57/58-A2 Each film coated tablet dated 21-09-2016 Pakistan.
Korangi Creek contains:- Rs.50,000/-
Industrial Park Sofosbuvir……400mg As per PRC GMP inspection report
Karachi Ledipasvir……90mg dated 10-07-2018
(Direct-acting antiviral concluding acceptable
agent against the hepatitis level of compliance.
C virus)
(MFG Specs)

Drug Soladi Film Coated Tablet
Other proposed brand names
Sofo-Led
Hepled
Ledisof
Scihop-L
Sciled-C
Name of Manufacturer M/s Scilife Pharma (Pvt.) Ltd, Plot FD-57/58-A2
Korangi Creek Industrial Park , Karachi
Manufacturer of API Sofosbuvir: M/s Nantong Chanyoo Pharmatech. Co. ltd.
Ledipasvir –Co-povidone: Ruyuan HEC Pharm
API Lot No. Sofosbuvir: RD-SFB (Form VI) -201703091
Ledipasvir –Co-povidone: YAXi-201704003
Description of Pack
Alu- Alu blister with unit carton
Time Period Real time: 6 Months
Accelerated: 6 Months
Frequency Accelerated: 0,3,6 Month
Real Time: 0,3,6 Month
Batch No. SF002 SF003 SF004
No. of Batches 3
Date of Submission 26-11-2018 (Dy. No. 38654)
No.
1. COA of API Yes
Sofosbuvir: RD-SFB (Form VI) -201703091
Ledipasvir –Co-povidone: YAXi-201701002(Previous
Lot No)
Ledipasvir –Co-povidone: YAXi-201704003(New Lot
No)
2. Approval of API by regulatory authority of Sofosbuvir:Copy of Certificate of GMP compliance
country of origin or GMP certificate of API issued to M/s Nantong Chanyoo Pharmatech by Agency
manufacturer issued by regulatory authority of for medicinal products and medical devices of the
country of origin. Republic of Solvenia. (verified from EU GMP database).
Ledipasvir –Co-povidone: Copy of GMP certificate
issued by Shaoguan food and Drug Administration has
been submitted for M/s Ruyuan HEC Pharm Co., Ltd.
The certificate is valid up to 17-06-2018.
Yes
4. Data of 03 batches will be supported by
Yes
etc.
5. Documents confirming import of API etc. Sofosbuvir
 Copy of Form 6 (License to Import drug) issued by
ADC (Karachi) dated 15-06-2017, for the import of
Sofosbuvir 1 kg from the M/s Nantong Chanyoo
Pharmatech Co., Ltd. China has been submitted.
 Copy of Commercial Invoice (invoice no.
CY117186B) attested by ADC (Karachi) dated 20-
06-2017 has been submitted. Batch No RD-SFB
(Form VI) -201703091.
 Issuer: Changzhou Pharmaceutical Factory.
Ledipasvir Co-povidone
Correction in Ledipasvir Copovidone Lot No. used in
stability batches of Sofoled, erroneously the ADC
approval of Ledipasvir Copovidone attached is not of
that lot which is used in submitted stability batches. The
batches were manufactured by another lot which was
received from manufacturer via FedEx to Scilife Pharma
Private without any custom clearance.
data / documents.
Yes
Yes
Rules, 1978.
 Brand name mentioned on Form 5 is Soladi whereas in protocols and provided data you have mentioned
Sofo-Led.
 Scilife already have the export purpose registration of the said combination Soladi with Brand name Sofo-
Led 400/90 mg Tablet. Hence the overall technical and stability documents of the said combination was
being prepared, done and submitted with the brand name Sofo-Led tablet.
Meeting:
1. Reference of last onsite panel inspection for Registration Board approved ROMILAST (Roflumilast
instant dosage form conducted during last 500mcg) Tablets and TASVIR (Daclatasvir 60mg) Tablets in
two years. its 275th Meeting.
 Date of Inspection: 05th October, 2017 (Morning).
 The HPLC software is 21CFR Compliant as per
record of the firm.
 Audit trail on the testing reports (of ROMILAST and
TASVIR) can be made. Physically the related audit
trial was checked and found in order.
2. Documents for the procurement of API with Sofosbuvir
approval from DRAP (in case of import). i. Copy of Form 5 (License to Import drug) issued by
Licensing Authority (Karachi) dated 15-06-2017, for
the import of Sofosbuvir from the M/s Nantong
Chanyoo Pharmatech Co., Ltd. China has been
submitted.
ii. Copy of Commercial Invoice
Invoice no. CY117186B
Attested by ADC (Karachi) dated 20-06-2017.
Batch No RD-SFB (Form VI) -201703091.
Quantity: 1 Kg
Issuer: Changzhou Pharmaceutical Factory.
Ledipasvir Co-povidone (0.5 Kg)
Correction in Ledipasvir Copovidone Lot No. used in
stability batches of Sofoled, erroneously the ADC approval
of Ledipasvir Copovidone attached is not of that lot which is
used in submitted stability batches. The batches were
manufactured by another lot which was received from
manufacturer via FedEx to Scilife Pharma Private without
any custom clearance. As a proof of shipment procured from
the approved source firm has submitted the following
documents:
Shipment and Transportation Documents
 Airway Bill
 Good Declaration From Fed- Ex
 Parcel Travel History
 Fed- Ex proof of delivery
 Import Duty Statement
3. Documents for the procurement of reference Sofosbuvir
standard and impurity standards. Changzhou Pharmaceutical Factory have provided material
of Sofosbuvir Form VI 1.5Kg to M/s Scilife Pharma, along
with dispatched impurities of Sofosbuvir Form VI along with
working standard against bracketed invoice no CyI16166
Ledipasvir-Co-povidone DMF Declaration
Ruyuan Pharma HEC Pharm Co. confirmed that they have
supplied Ledipasvir&Co-povidone Solid dispersion along
with working standard and impurities standard in Feb 2017.
4. Approval of API/ DML/GMP certificate of Sofosbuvir: Copy of Certificate of GMP compliance issued
API manufacturer issued by regulatory to M/s Nantong Chanyoo Pharmatech by Agency for
authority of country of origin. medicinal products and medical devices of the Republic of
Solvenia. (verified from EU GMP database)
Ledipasvir –Co-povidone: Copy of GMP certificate issued
by Shaoguan food and Drug Administration has been
submitted for M/s Ruyuan HEC Pharm Co., Ltd. The
certificate is valid up to 12-12-2018.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for qualification of vendors for
raw materials and packaging material.
6. Certificate of analysis of the API, reference Sofosbuvir
standards and impurity standards API Batch. #
Sofosbuvir Form VI RD-SFB-201703091
Sofosbuvir Form VI WSFB39-170401
SFBA-1 WSFB10-170601
Impurity A SFB WSFB13-170601
Impurity B SFB WSFB14-170601
Methyl-ester SFB WSFB07-170601
Amino-SFB WSFB08-170601
Chloro-SFB WSFB05-170601
Pentafluorophenol WSFB12-170601
2-hydroxymethyl SFB WSFB09-170601
SFBMA WSFB11-170601
SFBD3 WSFB15-170601

SFBE WSFB02-170601
SFBD1 WSFB03-170601
SFBD2 WSFB02-170601
Ledipasvir and Co-povidone Solid Dispersion
API YAXi-201701002
(Previous Lot No COA)
Reference Standard HCS15429-42
Supplied By Dongguan
Changan HEC Pharm
Scilife COA WS-RD-LED/01
Working Standard
Manufacturer
HEC Pharma
Supplier
WIS Group
Impurity A Reference HCS14416-25-02
Standard
Changan HEC Pharm
Impurity C Reference HCS14401-22-02
Standard
Changan HEC Pharm
7. Documents for the procurement of excipients The firm has submitted commercial invoices & COAs of
used in product development? excipients used in formulation from relevant manufacturers.
MCC 102 Sigachi Industries, SH/16101727
Pashammailaram, India
Lactose Kerry Ingredients, 0000981612
Monohydrate Mumbai , India
Croscarmellos Gujarat Microwax 7111507225
e Nandasan, India
Colloidal Evonik Industries 156050314
Silicon Germany
Dioxide
Aerosil
Magnesium Nitika Pharmaceutical MGST1F252
Stearate Specialities, Nagpur
HPMC Shin Etsu DEAT26172
5
PEG 6000 Pan Asia Chemical Corp 20150320
Titanium Cosmo Chemical K521-10120
Dioxide Korea
Talcum Nitika Pharmaceutical PUTA2F163
Powder Specialities, Nagpur
development.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted SOP of Product development and
development & stability testing of trial protocol for stability studies specific to the product.
batches.
three stability batches. Record and batch packaging record of the following 03
Batches.

Batch Reconciliation After Batch Completion
SF002
324 Tablets:
SF003
322 Tablets:
SF003
322 Tablets:
11. Record of remaining quantities of stability Description B.No:SF002 B.No:SF003 B.No:SF004
batches. Theoretical 800 tablets 800 tablets 800 tablets
Batch Size
Total produced 761 762 762
Used for initial 50 50 50
testing
Kept On 245 245 245
30°C/RH75%
Kept On 70 70 70
40°C/RH75%
Remaining On 105 105 105
30° C/RH75%
Remaining On - - -
40° C/RH75%
Total used for 72 - -
CDP
Remaining 324 397 397
quantities in
R&D
QA / QC DATA
12. Record of Digital data logger for temperature  Tabular record of Digital data logger for temperature and
and humidity monitoring of stability humidity monitoring of stability chambers has been
chambers (real time and accelerated) submitted.
13. Method used for analysis of API along with Sofosbuvir & Ledipasvir Co-povidone
COA. Firm has provided method but not performed the complete
testing of API e.g. Isomers identification, Related substances
and residual solvent Their provided method is as per vendor.
14. Method used for analysis of FPP & complete  The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. specification & Test method.
chromatograms, lab reports, raw data sheets  Firm has submitted complete record of testing of
etc.) stability batches (i.e. chromatograms, lab reports, raw
data sheets etc.)
15. Reports of stability studies of API from Sofosbuvir
Accelerated and 12 Months Real Time Stability Study Data
of 03 Batches of API as per Zone-IVa conditions
Ledipasvir and Copovidone
Accelerated and 12 Months Real Time Stability Study
(30oC+2 oC, 60+5%) Data of 03 Batches of API.
16. Analysis reports for excipients used. The firm has submitted copies of its own Analytical reports
for all excipients used in product development.
17. Drug-excipients compatibility studies. Firm has not performed drug excipient compatibility studies
as they claim their qualitative composition of innovator and
Sofo-Led is same. However, that is not the case. The
comparison of innovator product and Sofo-Led is mentioned
below:
Harvoni Innovator Sofo-Led
Copovidone
Croscarmellose sodium Croscarmellose sodium
th
Microcrystalline cellulose Microcrystalline cellulose
Magnesium stearate Magnesium stearate
Lactose Monohydrate Lactose Monohydrate
Colloidal Silicon Dioxide Colloidal Silicon Dioxide
Film Coat Film Coat

Polyvinyl alcohol HPMC
PEG PEG
Talc Talc
Titanium Dioxide Titanium Dioxide
FDC Yellow Subset Yellow,
FCF Aluminum Lake
18. Record of comparative dissolution data. Firm has submitted protocol for comparative dissolution at
pH 1.2, pH 4.5 and pH 6.8. The details of reference product
& Sample product are as follows:
Feature Reference product Product of
by Hetero Labs Ltd M/s Scilife
Brand name Ledifos 400/90mg Sofo-Led
400/90mg
Batch No. 3117251 SF002
Mfg. date 01-2017 06-2017
testing.
Decision: Registration Board decided to approve registration of ―Sofolos Tablet400/90
(Sofosbuvir/Ledipasvir) by M/s Scilife Pharma (Pvt.) Ltd, Plot FD-57/58-A2Korangi Creek Industrial
Park , Karachi - Manufacturer will place first three production batches of the product on long term
stability studies throughout proposed shelf life and on accelerated studies for six months.
Case No. 07 Miscellaneous Cases.

a. Cases Referred by Appellate Board:
1. Omera (Omeprazole) & Esomega (Esomeprazole) Injections by M/s BF Biosciences Ltd., 5-
Km, Sundar Raiwind Road, Raiwind.
Following cases were presented in 277 th meeting of Registration Board, submitted on Form 5
along with enclosures on CTD format. The details of cases & decisions of Board are reproduced
as under:
416. Name and address of manufacturer / M/s BF Biosciences Ltd., 5-Km, Sundar Raiwind Road,
Applicant Raiwind.
Brand Name +Dosage Form + Strength Omera 40mg Infusion
(Lyophilized Powder For Solution For Intravenous Injection)
Omeprazole (as sodium) …40mg
Pharmacological Group Proton pump inhibitors
Type of Form Form-5
Pack size & Demanded Price 1‘s;As per SRO
Me-too status Risek Injection 40mg of M/s Getz Pharma (Reg.#024170)
GMP status Last inspection report 08-09-2017 Panel concludes good level
of GMP compliance.
Remarks of the Evaluator.  Firm has section approval for Biological parenteral only
whereas applied formulation does not fall in this category.
 Firm has submitted Enclosures along with form 5 as per
CTD format approved in 264th meeting of registration
Board.
 Firm has submitted reports of accelerated & real time
stability studies for three batches.
Decision: Registration Board deferred the case for personal hearing for clarification of firm‘s
request to manufacture applied formulation in Biological parenteral section.
417. Name and address of manufacturer / M/s BF Biosciences Ltd., 5-Km, Sundar Raiwind Road,
Applicant Raiwind.
Brand Name +Dosage Form + Strength Esomega 40mg Infusion
(Lyophilized Powder For Solution For Intravenous Injection)
Esomeprazole (as sodium) …40mg
Type of Form Form-5
Me-too status X-Prazole 40mg Infusion of M/s Mediate Pharmaceuticals,
Karachi (Reg.#057925)
GMP status Last inspection report 08-09-2017 Panel concludes good level
of GMP compliance.
Remarks of the Evaluator.  Firm has section approval for Biological parenteral only
whereas applied formulation does not fall in this category.
 Firm has submitted Enclosures along with form 5 as per
CTD format approved in 264th meeting of registration
Board.
 Firm has submitted reports of accelerated & real time
stability studies for three batches.
Decision: Registration Board deferred the case for personal hearing for clarification of firm‘s
request to manufacture applied formulation in Biological parenteral section.
Following details have been submitted of Module 3 (Quality / CMC) for both above cited
applications:
Contents of Module: 3 (Quality / CMC)
Sub- Data submitted
Module Section Contents
section
3 3.2.S DRUG SUBSTANCE
General Information Detail submitted for
i. Nomenclature
3.2.S.1
ii. Structure
iii. General properties
Manufacture Detail submitted for
i. Manufacturer(s)
3.2.S.2
ii. Description of Manufacturing Process and
Process Controls
Characterization Detail submitted for
i. Elucidation of Structure and other
3.2.S.3
Characteristics
ii. Impurities
Control of Drug Detail submitted for
Substance i. Control of Drug Substance
3.2.S.4 ii. Specification
iii. Analytical Procedures
iv. Validation of Analytical Procedures
v. Batch Analyses
vi. Justification of Specification
Reference Standards Detail submitted for Reference Standards
3.2.S.5
or Materials
Container Closure Detail submitted for Container Closure System
3.2.S.6
System
Stability Detail submitted for Stability. (Protocol & reports
3.2.S.7
have been submitted)
3.2.P DRUG PRODUCT
Description and Detail submitted for Composition of Drug Product

3.2.P.1 Composition of Drug
Product
Pharmaceutical Detail submitted for Components of the Drug
3.2.P.2
Development Product.
Manufacture Detail submitted for
i. Manufacturer(s)
ii. Batch Formula
iii. Description of Manufacturing Process and
3.2.P.3 Process Controls
iv. Controls of Critical Steps and
Intermediates
Undertaking has been submitted for Process
validation
Control of Excipient Detail submitted for
i. Specifications
3.2.P.4
ii. Analytical Procedures
All excipients used are of Pharmacopoeal grades
Control of Drug Detail submitted for
Product i. Specification(s)
3.2.P.5 ii. Analytical Procedures
iii. Validation of Analytical Procedures
(Protocol & report have been submitted)
Reference Standards Detail submitted for Reference Standards or
3.2.P.6
or Materials Materials
Container Closure Detail submitted for Container Closure System
3.2.P.7
System
Stability Following have been submitted:
i. Stability Summary and Conclusions
ii. Post-approval Stability Protocol and
3.2.P.8
Stability Commitment
iii. Stability Data (Only reports have been
submitted.)
 Now, the firm has requested for personal hearing before the Honourable Drug
Registration Board to enable to them to present their case. The representatives of the firm
now have been called upon for personal hearing.
Proceedings: Dr. Ajmal Nasir (Director Technical) appeared before the Board and briefed
regarding justification for the manufacturing of non- biologicals along with bio-pharmaceuticals
at BF Biosciences Ltd as under:
―BF Biosciences is manufacturing six products i.e. Interferon Alpha 2a, Interferon Alpha 2b,
Pegylated interferon alpha 2a, Erythropoietin, Filgrastim and Terlipressin acetate injections.
Drug Substances manufactured using a Biological system using living organisms/cel l lines
through culturing or Recombinant DNA are termed as BIOLOGICALS, whereas Drug Products
manufactured using already produced Biological Drug Substances (which no longer contain
living organisms) are termed as Bio-Pharmaceuticals. Dedicated facility is required for the
manufacturing of BIOLOGICAL SUBSTANCES and certain other highly sensitizing
compounds etc., but not for biopharmaceuticals.
All above-mentioned products manufactured at BF Biosciences are Bio-Pharmaceuticals. These
bio-pharmaceutical formulations are peptides that are easily denatured by temperature as well as
pH changes, and thus can be eliminated from the facility through cleaning validation between
production batches. These do not therefore bear contamination risks carried by penicillin-based
antibiotics and other products requiring dedicated manufacturing facilities.
Bio-Pharmaceuticals formulation and filling / Lyophilization (if required) is allowed as per

WHO 1, Eudralex 2and FDA 3 guidelines along with non-Biopharmaceuticals on Campaign
basis.
At BF Biosciences we intend to avail this allowance to manufacture non-Biologicals along with

Bio-Pharmaceuticals on Campaign basis.
All required controls and systems are in place and are compliant to requirements for campaign-
based manufacturing of biopharmaceuticals and non- biologicals.‖
REFERENCES
1) Annex 3 WHO good manufacturing practices for biological products
Replacement of Annex 1 of WHO Technical Report Series, No. 822
Section 9 , 13 GMP OF BIOLOGICAL PRODUCTS WHO s22400en.pdf
2) EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
guidelines forGood Manufacturing Practice for Medicinal Products for Human and
Veterinary Us e Annex 2 Manufacture of Biological active substances and Medicinal
Products for Human Use Section 8 g and 9
3) FDA approves BioMarin‘s manufacturing facility in Cork, Ireland he FDA has
approved BioMarin Pharmaceutical‘s bulk biologics manufacturing plant, located in Cork,
Ireland for production of the formulated bulk substance. Niamh Marriott (European
Pharmaceutical Review)
 It is pertinent to mention that M/s BF Biosciences Ltd. Lahore was previously granted
registration for Omega injection (Omeprazole), Reg. No. 067967, in same manufacturing
facility vide letter no. F.15-7/2010-Reg-V (M-228) dated 10-12-2010.
Later Central Licensing Board in 235th meeting while discussing the case of renewal of DML
of M/s BF Bio Sciences, Lahore passed following orders in respect of Omega injection
(Omeprazole) , Reg. No. 067967:-3
―The Board was apprised by licensing division that the firm in its renewal application has
mentioned that they have registration of omeprazole at biotech facility where as panel in the
inspection report has mentioned that the firm has dedicated biotech manufacturing facility
only. The Board in this regard advised to refer the case of registration of Omega injection
(Omeprazole), Reg. No. 067967 to Drug Registration Board for its consideration and further
necessary action accordingly‖.
Registration Board in its 245th meeting held on 29th & 30th September, 2014 decided to issue
show cause for cancellation of registration of Omega injection (Omeprazole), Reg. No.
067967, registered in the name of M/s BF Biosciences Ltd. Lahore.
Subsequently Omega injection (Omeprazole), Reg. No. 067967 of M/s BF Biosciences Ltd.
Lahore, was de-registered vide letter no. F.15-2/2015-Reg-V (M-247)
Decision of 278th meeting: Registration Board deliberated the matter in detail and decided to
refer the case to Central Licensing Board for their comments on firm‘s request as
CLB has granted for Biological parenteral section only.

Subsequently the firm appealed before the Appellate Board, wherein the case was presented in
151st meeting of the Appellate Board. The proceedings and order of the Appellate Board are
reproduced as under:
BEFORE THE APPELLATE BOARD IN ITS 151ST SITTING HELD ON
16TH JANUARY, 2019
ORDER
Appeal No. 32/2018

Appellant: M/s BF Biosciences, Lahore
Appeal preferred against the decision of: Central Licensing Board
Decision Appealed Against: Appeal against rejection of application
for manufacturing of non-biological
parental preparations at the facility of
biological preparations.
Date of the issuance of the decision: 07-08-2018
Date of the Appeal received: 04-10-2018
Present:
1. Dr. Dr. Shaikh Akhter Hussain Chairman

2. Dr. Jamil Anwar Member
3. Mr. Qaiser Muhammad Member
4. Mr. Salim Khan Member
5. Dr. Farzana Chaudhary Member (Expert)
6. Brig. Dr. Akbar Waheed Member (Expert)
7. Prof. Dr. Maqsood Ahmad Member (Expert)
8. Mr. Shahid Nasir Member (Expert)
Appellant represented by:
1. Mr. Omar Waheed, General Manager, M/s BF Biosciences, Lahore.

2. Mr. Baqar Hasan, Director (Reg. & Legal), M/s BF Biosciences, Lahore.
3. Dr. Ajmal Nasir, Director (Technical), M/s BF Biosciences, Lahore.
Proceedings:
The appellant challenged the decision passed by the Central Licensing Board in its 264th
meeting held on 09-07-2018 whereby the Central Licensing Board in its 264 th meeting held on
9th July, 2018 has considered their request for campaign manufacturing of non-biological
products in biological manufacturing facility under DML No. 000655 and decided as under:
―The Central Licensing Board considered the report of the Technical Evaluation
Committee and decided to regret the permission for manufacture of non-
biological parental preparations at the facility of biological preparations at M/s BF
Biosciences Limited, Lahore under Drug Manufacturing License no. 000655
(formulation) on campaign manufacture basis as no such circumstances
/exceptional case of emergency exists as required under the rules. The same may
be conveyed to Drug Registration Board as the case was referred by the said
Board for comments. The Central Licensing Board however, considered the
recommendations at Serial No. 2 of the Committee and also decided to forward
the same to Drug Registration Board for consideration.‖

2. Furthermore, the Central Licensing Board approved the recommendations of Technical
Evaluation Committee at Serial No. 2 that BF Biosciences may be facilitated by processing
pending applications for biological drugs on priority to overcome underutilization of the facility
as country needs biological products as well.
3. The representative of the firm delivered a comprehensive presentation. The main thrust of
argument of the appellant was that the firm is not producing biological but bio-pharmaceuticals.
He further submitted that the terms ―biological‖ and ―biopharmaceutical‖ are defined as
follows:-
BIOLOGICAL PRODUCT:--A virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, or analogous product, or
arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic
compound), applicable to the prevention, treatment, or cure of a disease or condition of
human beings.
REFERENCE: 42 U.S. Codex. 262(a) FDA
Since all the products filled by BF Biosciences are peptides and proteins in nature they
did not fall in the definition of Biologics as described above and hence are not Biologics.
Peptides and proteins are considered a s Biopharmaceuticals due to the use of Living
organism in the manufacture of the final product. However, the finished product does not
contain any live organism as given in definition below.
BIO PHARMACEUTICALS:--A therapeutic product made through the genetic

manipulation of living things or their cells, including (but not limited) proteins and
monoclonal antibodies, peptide, and other molecules that are not chemically synthesized,
along with gene therapies, cell therapies and engineered tissues. Biopharmaceuticals
ethical pharmaceutical drugs derived through bioprocessing.
REFERENCE: Glossary, International Society of Pharmaceutical Engineers (ISPE)
4. The representative of the firm added that there is no reference in any guideline
requirement for separate formulation and filling sections for biopharmaceutical and
pharmaceutical products. However extra care is advised vide:-
(i) EudraLex The Rules Governing Medical Product in the European Union (Vol. 4).
(ii) EU Guideline for Good Manufacturing Practice for Medicinal Products for
Human and Veterinary Use.
5. Following examples of permissions to manufacture biopharmaceutical & non
biopharmaceutical on campaign basis were quoted by the firm:-
(i) FDA has approved BioMarin Pharmaceuticals‘s bulk biologics manufacturing
plant, located in Cork, Ireland for production of the formulated bulk substance.
(Elsufase alfa (trade name Vimizim) is a drug for the treatment of Morquio
syndrome which is caused by deficiency in the enzyme N-acetylagalcatosamine-
6-sulfatase. Elosulfase alfa is synthetic version of the enzyme (non Biological
product). This facility is for the manufacturing of Bulk biologics and allowed to
manufacture bulk for their product Vimizim ( Elosulfase alfa) is a non-biological
product on campaign based manufacturing by following The above mentioned

guidelines for change over and campaign based manufacturing and use facility as
multiproduct facility.
(ii) Baxter‘s facility at Halle Germany. Based on ―Risk Assessment‖ combined with
State of the Art Organizational Procedures & Technical Standards in accordance
with Industry Standards Baxter was allowed to manufacture:
o Small Molecules (cytotoxic & non Cytotoxic)
o Liposomal & NOano particle Formulation
o Monoclonal antibodies
o ADCs (Antibody Drug Conjugates)
o Nocleic Acid Products e.g. Gene Therapeutics.
Baxter was allowed to manufacture small molecules (non biopharmaceuticals) along with
biopharmaceuticals including Liposomal and Nano particle formulation, MABS, DCs etc based
on guidelines on campaign based manufacturing and risk assessment and mitigation.
Bio Pharmaceuticals Non Biopharmaceuticals
Liposome‘s Oxiplatin
Enoxaparin Sodium Lidocaine
Heparin Sodium Gentamicin
MABs (Monoclonal Anti Bodies)
ADCs (antibody Drug Conjugates
6. Responding to a query raised by the Chairman regarding campaign manufacturing
timetable, the firm proposed to change over on quarterly basis due to shelf life requirement in
tender business. Following checklist will be strictly observed on change over from
biopharmaceutical to non-biopharmaceuticals (and vice versa) which will be verified by DRAP:
CHANGE OVER CHECKLIST
Sr. Activity Date:
1 Last Production campaign was for
Yes No
2 All manufacturing/Formulation Equipment for last manufacturing campaign
removed from area and kept segregated.
3(a) Dispensing area is cleaned, sanitized as per SOP after last campaign and logged
in.
3(b) Formulation Area is cleaned, sanitized as per SOP after last campaign and logged
in.
3(c) Filling Area is cleaned, sanitized as per SOP after last campaign and logged in.
4 Changeover of Machine and filling machine as per change over SOP & logged in.
5 Freeze dryer is cleaned and sterilized through CIP & SIP procedure and logged in
after last campaign.
6 New change parts are installed after cleaning as per approved SOP and
Sterilization.
7 All Manufacturing equipment & filling parts are product specific / dedicated and
logged in.
7. Prof. Dr. Maqsood Ahmad stated the protocols are different for both products i.e.
biological and pharmaceutical. Patients cannot be put to risk by allowing campaign
manufacturing. The firm clarified that they are manufacturing bio-pharmaceuticals and not
biological products. As per international guidelines, manufacturing of bio-pharmaceuticals with
pharmaceuticals on campaign basis is allowed.
Decision:
8. The Board noted that the firm has very stringent quality assurance mechanism with state
of the art manufacturing and quality control facility in line with the international regulations.
9. The Board allowed the appeal and permitted M/s BF Biosciences, Lahore for
manufacturing of proton-pump inhibitors (Omeprazole & Esomeprazole) in already approved
section for biological drugs on campaign manufacturing basis. The Secretary, Registration Board
is directed to place the following products of the appellant before the Registration Board in its
forthcoming meeting and issue registrations within 30 days thereof:-
(i) Omera (Omeprazole) 40mg injection.
(ii) Esomega (Esomeprazole) 40mg injection.
10. The appellant may be allowed to manufacture other proton-pump inhibitors, including
Lansoprazole and Dexlansoprazole, if it fulfills the requirement of CTD dossier. However, the
campaign manufacturing is allowed on the basis of change over checklist mentioned in
paragraph 6 (above) subject to verification by the panel comprising the following, before each
interval of production:-
(i) Mr. Shahid Nasir (Member, Appellate Board); and

(ii) Mt. Asim Rauf, Additional Director (E&M), DRAP, Lahore.
Decision of 288th meeting: Registration Board deferred above products for the submission of
following as required by the CTD:
i. Stability data of three batches as per Zone-IVA conditions according to directions of
Registration board in oits 278th meeting.
ii. Process validation data.
Evaluation by PEC: The firm has submitted that our applications of ―Omera (Omeprazole)
40mg injection‖ & ―Esomega (Esomeprazole) 40 mg injection‖ were also submitted on Form-5
dated 04-10-2017 & 03-10-2017 respectively. Hence the firm as requested to consider their
products on Form-5 where the stability data and process validation is not required for
registration.
Decision: Registration Board acceded with firm‘s request and approved ―Omera
(Omeprazole) 40mg injection‖ & ―Esomega (Esomeprazole) 40 mg
injection‖. The campaign manufacturing is allowed on the basis of change
over checklist mentioned in paragraph 6 (above) subject to verification by
the panel comprising the following, before each interval of production:-
(i) Mr. Shahid Nasir (Member, Appellate Board); and
(ii) Mt. Asim Rauf, Additional Director (E&M), DRAP, Lahore.
b. Registration of Cysteamine
Chief Drugs Controller, Punjab vide letter No. CDC/INT-CC/172/2019 dated 08-01-2019
has requested the CEO, DRAP to take the needful action to ensure the availability of
Cysteamine in Pakistan by registering it at earliest, since the said drug is not registered in
Pakistan and it is indicated for life threatning genetic disorder named Cystinosis.
In this regard it is submitted for information of Board that till date no registration
application of ―Cysteamine‖ could be identified in available entered record.
Decision: Registration Board decided that any submitted application of ―Cysteamine‖

will be considered on priority upon completion of relevant codal formalities.

Evaluator PEC-III
Case no. 01: Registration applications for local manufacturing of (Human) drugs
a. Deferred cases
418. Name and address of manufacturer / M/s Novamed Pharmaceuticals (Pvt) Ltd., 28 KM, Ferozepur
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Tamflo Capsule
Tamsulosin hydrochloride…..0.4mg
Pharmacological Group Selective alpha 1 receptor antagonist
Type of Form Form 5
Approval status of product in Diffundox XL 400 microgram Capsules by Winthrop
Reference Regulatory Authorities. Pharmaceuticals (MHRA Approved)
Me-too status Tamsolin capsule by Getz
GMP status GMP inspection conducted on 5th and 27th December 2017
with conclusive remarks that firm is compliant to good cGMP
at the time of inspection.
Remarks of the Evaluator3 Source of pellets along with GMP of manufacturer, stability
study data of pellets is not submitted.
Decision of previous meeting of Registration Board deferred the case for further
Registration Board deliberation(M-284)
Evaluation by PEC Firm has submitted source of pellets from Vision
Pharmaceuticals, Islamabad along with stability data of 3
batches. After the use of pellets, the label claim will become
Each capsule contains:
Tamsulosin hydrochloride (as SR pellets)……..0.4mg
Decision: Approved.
419. Name and address of manufacturer / M/s Delta Pharma Pvt Ltd.Plot. No. 9, Nowshera Industrial
Applicant Estate, Risalpur, Kpk, Pakistan
Brand Name +Dosage Form + Strength Ventodine 2mg/5ml Liquid Suspension
Composition Each 5ml of Suspension Contains:
Sulbutamol as Sulphate…2mg
Diary No. Date of R& I & fee Dy. No 39940: 04-12-2018 PKR 20,000/- : 04-12-2018
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml: As per SRO
Approval status of product in Reference Ventolin Syrup by Glaxo Wellcome
Regulatory Authorities. (MHRA Approved)
Me-too status Ventolin Syrup by GSK
GMP status Firm is granted additional sections Oral liquid (general) and
dry suspension (general) section on the basis of inspection
dated 12-10-2018
Remarks of the Evaluator.  Justify the formulation of liquid suspension, since the
MHRA approved reference formulation is liquid solution /
syrup. In case of revision of formulation fee (for revision
of formulation) needs to be submitted.
Decision of 287th meeting of RB Deferred for revision of formulation as per reference product
along with submission of requisite fee for change of
formulation
Evaluation by PEC  Firm has revised formulation as per reference product
along with submission of 5,000 fee dated 07-02-2019. The
revised formulation submitted by the firm is as:
Each 5ml of solution Contains:
Sulbutamol as Sulphate…2mg
th
Decision of 288 meeting of Deferred for submission of fee for revision of dosage form.
Registration Board
Evaluation by PEC Firm has submitted the balance fee i.e. 15,000/- dated 09-05-
2019 for revision of dosage form
Decision: Approved.
420. Name and address of manufacturer / M/s Delta Pharma Pvt Ltd. Plot. No. 9, Nowshera Industrial
Applicant Estate, Risalpur, KPK, Pakistan
Brand Name +Dosage Form + Strength Zindell 20mg/5ml Liquid Suspension
Composition Each 5ml Contains:
Zinc as Sulphate Monohydrate…20mg
Diary No. Date of R& I & fee Dy. No 39943: 04-12-2018 PKR 20,000/- : 04-12-2018
Pharmacological Group Zinc supplement
Type of Form Form-5
Finished Product Specification International pharmacopoeia
Pack size & Demanded Price 60ml: As per SRO
Me-too status Zincat-OD Syrup by Atco Pharma
GMP status Firm is granted additional sections Oral liquid (general) and
dry suspension (general) section on the basis of inspection
dated 12-10-2018
Remarks of the Evaluator.  Justify the formulation of liquid suspension, since the
WHO recommended formulation is liquid solution / syrup.
In case of revision of formulation fee (for revision of
formulation) needs to be submitted.
th
Decision of 287 meeting of RB Deferred for revision of formulation as per reference product
formulation
Evaluation by PEC  Firm has revised formulation as per reference product
along with submission of 5,000 fee dated 07-02-2019. The
revised formulation submitted by the firm is as:
Each 5ml of solution Contains:
Zinc as Sulphate Monohydrate…20mg
Decision of 288th meeting of Deferred for submission of fee for revision of dosage form.
Registration Board
Evaluation by PEC Firm has submitted the balance fee i.e. 15,000/- dated 09-05-
2019 for revision of dosage form
Decision: Approved.
Case No. 02: Registration Applications of Newly Granted DML or New Section (Human)
a. New DML
M/s Avensis Pharmaceuticals, Karachi. (New Licence)
CLB in its 267th meeting held on 31st Dec, 2018 has considered and approved the grant of DML to
Avensis Pharmaceuticals by way of Formulation with following nine sections:
i. Capsule (General) Section
ii. Sachet (General) Section
iii. Liquid Ampoule & Vial (General) Section
iv. SVP Infusion (General) Section
v. Dry Powder Injection (Cephalosporin) Section
vi. Tablet (Psychotropic) Section
vii. Liquid Ampoule (Psychotropic) Section
viii. Dry Powder Suspension (Cephalosporin) Section
ix. Capsule (Cephalosporin) Section
Accordingly DML has been issue by secretary CLB vide letter no. F.2-6/2017-Lic. Dated 08-01-
2019. Number of DML: 000894.
Some applications have already been considered by the Board in its 288 th meeting. The details of
freshly applied products along with balance of molecules left after 288 th meeting is given in the table
below.
Following applications applied by firm are hereby presented for consideration of Board.
No. of molecules Fresh Fresh Total
Sr.
Section considered in M- molecules products molecules
No
288 applied applied
1. Sachet (General) Section 0 6 7 6
Liquid Ampoule & Vial (General) 7 9 10
2. 3
Section
3. Capsule (Cephalosporin) Section 0 4 7 4
Liquid Ampoule & Vial (General) Section:
09 product/ 07 molecule
421. Name and Address of Manufacturer / M/s Avensis Pharmaceuticals, F-24/1, Eastern Industrial
Applicant Zone, Port Muhammad Bin Qasim Karachi
Brand Name + Dosage Form+Strength Vital D3 Injection 5mg/ml
Diary No. Date of R & I & fee Dy.No 10773: 05-03-2019 PKR 20,000/-: 05-03-2019
Composition Each 1ml Ampoule Contains:
Cholecalciferol…200,000 IU
Pharmacological Group Vitamin D supplement
Type of Form Form 5
Pack Size & Demanded Price 1‘s, 5‘s: As per SRO
Approval Status of Product in VITAMIN D3 GOOD 200 000 IU / 1 ml, oral solution in
Reference Regulatory Authorities. ampoule by Bouchara-Recordati (ANSM FranceApproved)
Me-too Status CCL-D Injection by CCL Pharma (Reg#077118)
GMP Status 28-11-2018; Grant of DML Panel recommends Grant of DML
Decision: Approved.
Brand Name + Dosage Form+ Strength Ranit 50mg/2ml Injection
Ranitidine Hcl Eq. to Ranitidine…50mg
Type of Form Form 5
Approval Status of Product in Ranitidine 50mg/2ml Solution for Injection and Infusion by
Reference Regulatory Authorities. Alliance Pharmaceuticals (MHRA Approved)
Me-too Status New-Dine Injection by News Pharma (Reg#077156)
Decision: Approved.
Brand Name + Dosage Form+ Strength Tramasis 100mg/2ml Injection
Tramadol HCl…100mg
Pharmacological Group Opioid Analgesic
Type of Form Form 5
Finished Product Specification Firm has claimed in house specification
Approval Status of Product in Tramadol 50 mg/ml solution for injection/infusion by AS
Reference Regulatory Authorities. KALCEKS (MHRA Approved)
Me-too Status TOMDOL Injection 100mg by Rasco Pharma (Reg#074988)
3
Brand Name + Dosage Form +Strength Haemofer 100mg/5ml Injection
Iron III Hydroxide Sucrose Complex eq to elemental Iron as
…100mg
Type of Form Form 5
Pack Size & Demanded Price 5‘s: As per SRO
Approval Status of Product in Venofer Injection by LUITPOLD (USFDA Approved)
Me-too Status Venofer I.V. Injection of M/s Gastro Care Karachi
(Reg.#023654)
Brand Name +Dosage Form + Strength Mecovit 500mcg/ml Injection
Mecobalamin…500mcg
Pharmacological Group Vitamin B 12 analogue
Type of Form Form 5
Approval Status of Product in PMDA Japan Approved
Me-too Status Flench Injection by Tabros Pharma (Reg#029050)
3
Brand Name + Dosage Form+ Strength Vitamin B-12 1000mcg/2ml Injection
Composition Each 2ml ampoule contains:
Vitamin B12 (Cyanocobalamin)…1000mcg
Type of Form Form 5
Finished Product Specification JP Specs
Approval Status of Product in B12 Steigerwald solution for injection by Bayer Vital GmbH
Reference Regulatory Authorities. (Germany Approved)
Me-too Status Newbal Injection by News Pharma (Reg#078919)
GMP Status 28-11-2018; Grant of DML
Panel recommends Grant of DML
Decision: Approved.
Brand Name + Dosage Form+ Strength Vitamin B-12 1000mcg/1ml Injection
Diary No. Date of R & I & fee Dy.No 17412: 07-03-2019 PKR 20,000/-:06-03-2019
Vitamin B12 (Cyanocobalamin)…1000mcg
Type of Form Form 5
Approval Status of Product in B12 >> Ankermann << 1000 μgsolution for injection by
Reference Regulatory Authorities. Wörwag Pharma GmbH (Germany Approved)
Me-too Status Cyanocobalamin Injection by Amaan Pharma (Reg#094555)
Decision: Approved.
Brand Name + Dosage Form+ Strength Lincosis 600mg/2ml Ampoule
Lincomycin Hcl Monohydrate eq. to Lincomycin…600mg
Type of Form Form 5
Approval Status of Product in LINCOMYCIN SXP lincomycin (as hydrochloride
Reference Regulatory Authorities. monohydrate) 600 mg/2 mL solution for injection ampoule by
Southern Cross Pharma Pty Ltd (TGA Approved)
Me-too Status Lincomycin Injection by Amaan Pharma (Reg#087509)
Decision: Approved.
Brand Name + Dosage Form+ Strength Lincosis 600mg/2ml Vial
Composition Each 2ml vial Contains:
Lincomycin HCl Monohydrate Eq. to Lincomycin…600mg
Type of Form Form 5
Pack Size & Demanded Price 1x1‘s: As per SRO
Approval Status of Product in LINCOCIN lincomycin 600 mg/2 mL (as hydrochloride)
Reference Regulatory Authorities. injection vial by Pfizer Australia Pty Ltd (TGA Approved)
Me-too Status Lincomin Injection 600 mg by Elite Pharma (Reg#080198)
Decision: Approved.
Sachet (General) Section: 07 product/ 06 molecule
Brand Name + Dosage Form+ Strength Ruler Insta 20mg Sachet
Omeprazole….................20mg
sodium bicarbonate….....1680mg
Type of Form Form 5
Pack Size & Demanded Price 10‘s, 14‘s, 20‘s: As per SRO
Approval Status of Product in Zegerid powder for oral suspension by Santarus Inc.
Reference Regulatory Authorities. (USFDA Approved)
Me-too Status Risek Insta Sachet 20mg+1680mg by Getz Pharma
(Reg#058547)
Decision: Approved.
Brand Name + Dosage Form+ Strength Ruler Insta 40mg Sachet
Omeprazole…40mg
sodium bicarbonate…1680mg
Type of Form Form 5
Approval Status of Product in Zegerid powder for oral suspension by Santarus Inc.
Me-too Status Risek Insta Sachet 40mg + 1680mg by Getz Pharma
(Reg#058548)
Decision: Approved.
Brand Name + Dosage Form+ Strength Limka-Soda Sachet
Composition Each Sachet Contains:
Sodium bicarbonate…1.716g
Sodium citrate…0.613g
Citric Acid…0.702g
Tartaric Acid…0.858g
Pharmacological Group Antacid and anti-flatulent
Type of Form Form 5
Approval Status of Product in Could not be confirmed in the exact strength
Me-too Status Citro soda sachet by Abbott
Remarks of the Evaluator3 Following TGA approved product was quoted by the firm
URACOL Effervescent Granules oral powder sachet
citric acid……………….. 720 mg
sodium bicarbonate ……..1.76 g
sodium citrate……………630 mg
tartaric acid………………890 mg
Registration Board has already approved case of Martin Dow

for a product Lemo Soda Sachet 4gm on the basis of me-too
status because the formulation is considered OTC in various
authorities. The approved product of Martin Dow contains
tartaric acid 0.856gm
authorities/agencies which were adopted by the Registration Board in its 275 th meeting.
Brand Name + Dosage Form+ Strength Oasis Sachet
Sodium Chloride…2.6g
Potassium Chloride…1.5g
Sodium citrate Dihydrate…2.9g
Glucose…13.5g
Pharmacological Group Oral rehydration therapy
Type of Form Form 5
Approval Status of Product in WHO recommended low osmolarity formula
Me-too Status Omene ORS Sachet by Winthrox (Reg#080538)
3
Decision: Approved.
Brand Name + Dosage Form+ Strength Smecdral Sachet
Dioctahedral Smectite…3g
Pharmacological Group Other intestinal adsorbents
Type of Form Form 5
Approval Status of Product in ANSM approved
Me-too Status G-SMECTA Sachet by GT Pharma (Reg#080688)
Brand Name + Dosage Form+ Strength ORS Sachet
Sodium Chloride…1.3g
Potassium Chloride…0.75g
Sodium citrate Dihydrate…1.45g
Glucose…6.75g
Pharmacological Group Oral rehydration therapy
Type of Form Form 5
Approval Status of Product in Low osmolar sachet for reconstitution in ½ Liter

Me-too Status Winlyt Sachet by Winthrox
Decision: Approved.
Brand Name + Dosage Form+ Strength Avezole Insta 20mg Sachet
Enteric coated granules of esomeprazole magnesium
trihydrate eq. to esomeprazole…20mg
Type of Form Form 5
Approval Status of Product in Nexium 20mg Sachet by Astrazaneca (USFDA Approved)
Me-too Status Somezol 40mg Sachet by Bosch Pharma (Reg#081612)
Capsule (Cephalosporin) Section: 07 product/ 04 molecule
Brand Name + Dosage Form+ Strength Novacef 200mg Capsule
Cefixime as Cefixime Trihydrate…200mg
Type of Form Form 5
Approval Status of Product in Spain approved
Me-too Status Cefim capsule by Hilton
Decision: Approved.
Brand Name + Dosage Form+ Strength Novacef 400mg Capsule
Cefixime as Cefixime Trihydrate…400mg
Type of Form Form 5
Approval Status of Product in Spain approved
Me-too Status Cefim capsule by Hilton
Decision: Approved.

Brand Name + Dosage Form+ Strength Avadrox 500mg Capsule
Cefadroxil Monohydrate eq. to Cefadroxil…500mg
Type of Form Form 5
Approval Status of Product in MHRA Approved
Me-too Status Evacef Capsules 500mg by Highnoon
Decision: Approved.
Brand Name + Dosage Form+ Strength Viocef 250mg Capsule
Cefradine as Cefradine Monohydrate…250mg
Type of Form Form 5
Me-too Status Velosef capsule
Decision: Approved.
Brand Name + Dosage Form+ Strength Viocef 500mg Capsule
Cefradine as Cefradine Monohydrate…500mg
Type of Form Form 5
Me-too Status Velosef capsule
Decision: Approved.
Brand Name + Dosage Form+ Strength Avalex 250mg Capsule
Cephalexin Monohydrate Eq. to Cephalexin…250mg
Type of Form Form 5
Approval Status of Product in Keflex Capsule by Pragma (USFDA Approved)
Me-too Status Kix Capsule by Linta Pharma
Decision: Approved.
Brand Name + Dosage Form+ Strength Avalex 500mg Capsule
Cephalexin Monohydrate Eq. to Cephalexin…500mg
Type of Form Form 5
Approval Status of Product in Keflex Capsule by Pragma (USFDA Approved)
Me-too Status Kix Capsule by Linta Pharma
Decision: Approved.
Case No. 03: Registration Applications of Categories to be Considered on Priority

d. Local manufacturing applications of priority categories defined by Registration Board in its
257th meeting
444. Name and address of manufacturer / M/s Dyson Research Laboratories (Pvt) Ltd. 28th KM
Applicant Ferozepur Road Lahore
Brand Name +Dosage Form+ Strength Tamoxen Tablet 20mg
Tamoxifen (as citrate)……..20mg
Pharmacological Group Anti-estrogens (L02BA)
Type of Form Form 5
Approval status of product in TAMOXIFEN CITRATE20mg Tablet
Me-too status Tamoxifen-Sandoz 20mg Tablet by Novartis
GMP status Last inspection report 01-8-2017 with conclusion that panel
Remarks of the Evaluator3 
Decision: Approved.
445. Name and address of manufacturer / M/s Shaheen Pharmaceuticals, 3Km Murghzar Road, Saidu
Applicant Sharif Swat Pakistan
Brand Name+Dosage Form + Strength Shetrozole Tablet 2.5mg
Letrozole…….2.5mg
Pharmacological Group Aromatase Inhibitor (L02BG)
Type of Form Form 5

Approval status of product in Femara 2.5mg Tablet by Novartis
Reference Regulatory Authorities. (MHRA Approved)
Me-too status Femara 2.5mg Tablet by Novartis
GMP status Last GMP inspection conducted on 13-09-2018and the report
concludes that overall the firm was found to be GMP
compliant.

3
Decision:Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Brand Name +Dosage Form + Strength Carolimus Tablet 5mg
Composition Each Tablet contains:
Everolimus………5mg
Pharmacological Group Selective immunosuppressant (L04AA)
Type of Form Form 5
Finished Product Specification Innovator‘s
Approval status of product in Linevero 5mg Tablet by Ethypharm
Me-too status Afinitor 5mg Tablet by Novartis
compliant.

3
Decision: Approved.
Brand Name +Dosage Form + Strength Shamoxifen Tablet 10mg
Type of Form Form 5
Approval status of product in Nolvadex 10mg Tablet by Astrazaneca
Me-too status Tamoxifen-Sandoz Tablet by Novartis
compliant.
Decision: Approved.
Brand Name +Dosage Form + Strength Shamoxifen Tablet 20mg
Type of Form Form 5
Approval status of product in Nolvadex-D 20mg Tablet by Astrazaneca
Me-too status Tamoxifen-Sandoz 20mg Tablet by Novartis
compliant.
Decision: Approved.
449. Name and address of manufacturer / M/s McOlson Research Laboratories (Pvt) Ltd., 26 KM,
Applicant Lahore-Sharikpur Road Sheikhupura
Brand Name +Dosage Form + Strength Lefnomid 20mg Tablet
Leflunomide……..20mg
Pharmacological Group Selective immunosuppressants (L04AA)
Type of Form Form 5
Approval status of product in MHRA Approved
Me-too status Tablet Lufid 20mg by Swiss Pharma
GMP status Last GMP inspection report dated 15-02-2018
declaringfollowing ―General Observations‖: ―HVAC system
isproperly installed and functional in all production
areas.Overall cleanliness of the plant is good. Flow of
personalmovement, material movement and process is as per
cGMP.
The firm has sufficient production capacities formanufacturing
of different products in all sections. Howeverthe firm was
advised to improve documentation systemregarding validation
of testing procedure and manufacturingprocedure.
Decision: Approved.
450. Name and address of manufacturer / M/s McOlson Research Laboratories (Pvt) Ltd., 26 KM,
Applicant Lahore-Sharikpur Road Sheikhupura
Brand Name +Dosage Form + Strength Lefnomid 100mg Tablet
Type of Form Form 5
Me-too status Aidra 100mg Tablets by Wilshire
GMP status Last GMP inspection report dated 15-02-2018
declaringfollowing ―General Observations‖: ―HVAC system
isproperly installed and functional in all production
areas.Overall cleanliness of the plant is good. Flow of
personalmovement, material movement and process is as per
cGMP.
The firm has sufficient production capacities formanufacturing
of different products in all sections. Howeverthe firm was
advised to improve documentation systemregarding validation
of testing procedure and manufacturingprocedure.

Decision: Approved.
451. Name and address of manufacturer / M/s Caraway Pharmaceuticals Plot No. 12, Street N-3,
Applicant National Industrial Zone RCCI Rawat Islamabad
Brand Name +Dosage Form + Strength Lefluno 100mg Tablet
Type of Form Form 5
Me-too status Aidra 100mg Tablets by Wilshire
GMP status Last GMP inspection conducted on 19-12-2017, and thereport
concluded that the overall GMP compliance is Goodas of
today.
Decision: Approved.
e. EXPORT FACILITATION:
Following six cases were received from Assistant Director Reg-I vide letter No. F.7-7/2017-Reg-II (Vol-III)
dated 30thApril 2019. According to the contents of the letter the firm has achieved the benchmark of USD
501,457.13/- during the fiscal year 2017-18, now the firm has submitted list of 5 molecules (1 human and 4
veterinary) for consideration on priority as per the decision of 263 rd meeting of Registration Board.
Human
452. Name and address of manufacturer / M/s Hilton Pharma (Pvt) Ltd. Plot No. 13-14, Sector 15,
Applicant Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Rifix 550mg Tablet
Rifaximin……550mg
Type of Form Form 5
Pack size & Demanded Price 10‘s. 12‘s, 14‘s, 20‘s, 28‘s, 30‘s: As per DPC
Approval status of product in Targaxan 550mg film coated tablet by Alfasigma
Me-too status Faxim Tablet by StandPharm
concludes that firm is operating at satisfactory level of GMP
compliance.
Veterinary
Brand Name +Dosage Form + Strength Hilfen Injection 300mg/ml
Composition Each ml contains:
Florfenicol……300mg
Type of Form Form 5
Pack size & Demanded Price 10ml vial: Decontrolled
Me-too status Rivaflor 300 Injection by Mylab Pharma (Reg#078205)
Type of Form Form 5
Me-too status Flor-Vet Injection by Medivet (Reg#063546)
Type of Form Form 5
Me-too status Florofen Injection by Leads Pharma (Reg#043160)
Brand Name +Dosage Form + Strength Mycohil COL Liquid
Tylosin Tartrate……..100mg
Doxycycline HCL…..200mg
Colistin Sulfate……0.5MIU
Bromhexine HCl……..5mg
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 1000ml: Decontrolled
Me-too status CRD-COL LIQUID by Attabak Pharma (Reg#058879)

3
Brand Name +Dosage Form + Strength Hilworm suspension
Oxfendazole………22.65mg
Triclabendazole……85mg
Pharmacological Group Anti-helmintic
Type of Form Form 5
Me-too status Vorcid Suspension by Breeze Pharma (Reg#063563)
Case No. 04: Registration applications of import cases

a. Deferred cases
i. Human
458. Name and address of Applicant M/s Mehran International , Pliva Avenue Hume Road Near
World Map, Karachi, Pakistan
Detail of DSL Address: Mehran International, Plot No. JM 25/1 S.T. Homes
shop No. 4/4-A, Jamshed quarter, Karachi.
Name and address of manufacturer M/s Cisen Pharmaceutical Co., Ltd., Tongji Tech Industry
Garden, Jining High & New Technology Industries
Development Zone, Jining, Shandong Province China (As per
CoPP)
Name and address of marketing M/s Cisen Pharmaceutical Co., Ltd., Tongji Tech Industry
authorization holder Garden, Jining High & New Technology Industries
CoPP and Sole agency agreement)
Exporting agent for Pakistan:
M/s Ninhua Group Co., Ltd., 21 Jiangxia St. Ningbo, P.R. China
(as per sole agency agreement)
Name of exporting country China
Brand Name +Dosage Form + CARBOPLATIN IV Injection 100mg
Strength Freeze dried cake for solution for IV injection (Lyophilized
Powder)
Carboplatin…….100mg
Pharmacological Group Antineoplastic
Shelf life 2 years
Pack size 1×1‘s
International availability Cannot be confirmed
Me-too status Carboplatin for injection 100mg/vial by M/s Mehran
International. (Imported from China) (Reg # 052270)
Carboplatin for injection 100mg/vial by PakChina International
(Imported from China)(Reg # 066006)
Detail of certificates attached Original Legalized CoPP issued by Jining Food and Drug
Administration valid till 14/12/2017 confirms the free of the
product in exporting country. The facilities and operation
conform to GMP as recommended by WHO.
Remarks of the Evaluator.  The firm has applied for registration with generic name.
 Approval status of the product with strength 100mg/vial
cannot be confirmed. However product with 50mg/vial,

150mg/vial and 450mg/vial are approved by USFDA.
 Firm has initially submitted real-time stability data
conducted at 25 ± 2oc and 65 ± 5%RH, letter was issued to
submit stability study data conducted according to the
conditions of zone IV-A. In response to the letter firm has
submitted stability data sheet specifying stability conditions
as 30 ± 2oc and 65 ± 5%RH with same results at each time
point.
Previous Decision(M-274):
The Registration Board deferred the cases for;
 Submission of clarification regarding since the data/assay values in the stability studies are
unjustifiable/irrational as there is no difference in assay values of initially submitted stability data
(at 25 ± 2oc and 60 ± 5%RH) and the stability data submitted after issuance of letter (at 30 ± 2oc
and 65 ± 5%RH). Since this ambiguity shows that the revised data (at 30 ± 2 oc and 65 ± 5%RH)
is not true
 Evidence of approval status of the product in reference regulatory authorities in the applied
strength.
 Detail of diluent to be used for reconstitution.
Evaluation by PEC:
Shortcomings Response by the firm
Submission of clarification regarding since the Firm has submitted stability study data sheets
data/assay values in the stability studies are duly signed by the authorized personnel of
unjustifiable/irrational as there is no difference in manufacturer of 3 batches conducted as per
assay values of initially submitted stability data (at 25 the conditions of zone IV-A. The data
± 2oc and 60 ± 5%RH) and the stability data submitted is only for 6 months. The firm has
submitted after issuance of letter (at 30 ± 2oc and 65 NOT submitted any clarification regarding
± 5%RH). Since this ambiguity shows that the already submitted stability data sheets having
revised data (at 30 ± 2oc and 65 ± 5%RH) is not true. same values at both conditions.
Detail of diluent to be used for reconstitution. Firm has submitted details of preparation and
administration of the applied formulation.
Evidence of approval status of the product in Firm has not submitted any reference
reference regulatory authorities in the applied
strength.
After the evaluation of the response, another letter of shortcoming No. F.1-1/2017/PEC-DRAP(AD PEC-
V) was issued by dated 23-11-2018. Now the response of the firm against that letter is also received.
Clarifythe formulation whether Freeze dried Lyophilized powder
cake or lyophilized powder
The certifying authority for CoPP is Jinning Firm has submitted that ―as per the announcement
Food and Drug Administration which is not a of Shandong province food and drug
state or provincial certifying authority. administration, shandong province food and drug
administration authorize the city level food and
drug administration to issue CoPP. Since the
manufacturer M/s Cisen Pharmaceutical Co. Ltd. is
in Shandong province, therefore the city level
Jinning food and drug administration is authorized
to issue CoPP. Firm has also submitted following
link but it could not be accessed
http://www.sfda.gov.cn/art/2017/12/20/art_8045_7
82171.html
Evidence of approval of applied formulation in Firm has submitted evidence of USFDA which
reference regulatory authorities which were could not be verified
approved by Registration Board in its 275th
meeting
Product is present in USP and specification of Firm has submitted that their inner control
pH are more stringent in USP 5-7 while your standards (6.0-7.0) are more stringent than USP.
claimed specification are 5.5-7.5
Long term stability data of at least one year is Firm has submitted accelerated stability study
required for grant of 2 years shelf life whereas stability data of 3 batches for one year instead of
you have provided data of 6 months with results long term stability study data till claimed shelf life
of related substances out of specification.
Decision: Deferred for following submissions:
 Evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting
 Real time stability study data of 3 batches as per zone IV-A for the complete shelf life.
CoPP)
CoPP and Sole agency agreement)
Brand Name +Dosage Form + CARBOPLATIN IV Injection 200mg
Powder)
Carboplatin…….200mg
Pharmacological Group Antineoplastic agent, Platinum Containing cytotoxic
Shelf life 3 years
Diary No. & Date of R& I Dy. No. 3562Dated 6/03/2017
Pack size 1×1‘s
International availability Evidence of approval in Reference Regulatory Authority.
Me-too status Could not be confirmed
Detail of certificates attached Original Legalized CoPP issued by Jining Food and Drug
Administration valid till 14/12/2017 confirms the free of the
product in exporting country. The facilities and operation
 Agreement does not include the carboplatin.
 Evidence of approval in Reference Regulatory Authority.
 Stability data sheets of atleast 3 batches according to Zone
IVA.
 Valid drug sale license.
 Credentials are not signed .
 Certificate no is not mentioned on COPP.
 Clarification of pharmacological group.

 Mention the type of container.
 Product is present in USP while finished product
specifications are not as per USP. Like pH in USP is 5-7
while you have provided 5.5-7.5.
 URDU version label.
 Site master file or signed credentials.
Evaluation by PEC
Clarifythe formulation whether Freeze dried cake Lyophilized powder
or lyophilized powder
The certifying authority for CoPP is Jinning Food Firm has submitted that ―as per the announcement
and Drug Administration which is not a state or of Shandong province food and drug
provincial certifying authority. administration, shandong province food and drug
manufacturer M/s Cisen Pharmaceutical Co. Ltd.
is in Shandong province, therefore the city level
http://www.sfda.gov.cn/art/2017/12/20/art_8045_
782171.html
meeting
Product is present in USP and specification of pH Firm has submitted that their inner control
are more stringent in USP 5-7 while your standards (6.0-7.0) are more stringent than USP.
claimed specification are 5.5-7.5
Name and address of manufacturer M/s Shanxi PUDE Pharmaceutical Co., Ltd., First
Pharmaceutical Zone, Economic & Development Zone of
Datong, Shanxi, China
Name and address of marketing M/s Shanxi PUDE Pharmaceutical Co., Ltd., First
authorization holder Pharmaceutical Zone, Economic & Development Zone of
Brand Name +Dosage Form + CALCIUM FOLINATE injection 100mg
Powder)
Calcium folinate…. 100mg
Pharmacological Group Anti dot to folic acid antagonist/Detoxifying agent for
antineoplastic treatment
Shelf life 2 years
Pack size 1×1‘s
International availability Calcium folinate powder for solution 100mg/vial by M/s Mylan,
ANSM France Approved
Me-too status Calcium flogen 100mg injection by M/s Genetech (IMPORTED
from China ) (Reg # 059269)
Detail of certificates attached Original Legalized CoPP (certificate No. 20150008) issued by
Shanxi Food and Drug Administration valid till 31/08/2017
confirms the free of the product in exporting country. The
facilities and operation conform to GMP as recommended by
WHO.
point.
(at 25 ± 2oc and 60 ± 5%RH) and the stability data submitted after issuance of letter (at 30 ± 2 oc
is not true.
 Evidence of approval of the product in reference regulatory authorities in the same
strength/volume/dosage form.
 Submission of original, legalized and valid CoPP.
Evaluation by PEC:
unjustifiable/irrational as there is no difference in assay manufacturer of 3 batches conducted as per
values of initially submitted stability data (at 25 ± 2 oc the conditions of zone IV-A. The data
and 60 ± 5%RH) and the stability data submitted after submitted is only for 6 months. The firm has
issuance of letter (at 30 ± 2oc and 65 ± 5%RH). Since NOT submitted any clarification regarding
this ambiguity shows that the revised data (at 30 ± 2 oc already submitted stability data sheets having
and 65 ± 5%RH) is not true. same values at both conditions.
Evidence of approval status of the product in reference Firm has not submitted any reference
regulatory authorities in the applied strength.
Submission of original, legalized and valid CoPP Firm has submitted new CoPP which is valid
till 26-02-2020.

Clarifythe formulation whether Freeze dried cake or Lyophilized powder
lyophilized powder
The certifying authority for CoPP is Jinning Food Firm has submitted that ―as per the
and Drug Administration which is not a state or announcement of Shandong province food and
provincial certifying authority. drug administration, shandong province food and
drug administration authorize the city level food
and drug administration to issue CoPP. Since the
Jinning food and drug administration is
authorized to issue CoPP. Firm has also
submitted following link but it could not be
accessed
782171.html
approved by Registration Board in its 275th meeting
Variation in address mentioned on DSL and Form Firm has submitted revised Form 5A
5A. Clarify
required for grant of 2 years shelf life whereas you stability data of 3 batches for one year instead of
have provided data of 6 months with results of long term stability study data till claimed shelf
related substances out of specification. life
Name and address of manufacturer M/s Shanxi PUDE Pharmaceutical Co., Ltd., First
Pharmaceutical Zone, Economic & Development Zone of
Name and address of marketing M/s Shanxi PUDE Pharmaceutical Co., Ltd., First
authorization holder Pharmaceutical Zone, Economic & Development Zone of
Brand Name +Dosage Form + CALCIUM FOLIN ATE injection 300mg
Strength Freeze Dried cake for solution for IV injection (Lyophilized
Powder )
Calcium folinate…. 300mg
Pharmacological Group Anti dot to folic acid antagonist
Shelf life 3 years

Pack size 1×1‘s
International availability Could not be confirmed
(Approved as lyophilized powder for injection 200mg/Vial &
350mg/Vial)
Detail of certificates attached Original Legalized CoPP (certificate No. 20150009) issued by
Shanxi Food and Drug Administration valid till 15/09/2017
confirms the free of the product in exporting country. The
facilities and operation conform to GMP as recommended by
WHO.
 Firm has initially submitted real-time stability data conducted
at 25 ± 2oc and 65 ± 5%RH, letter was issued to submit
stability study data conducted according to the conditions of
zone IV-A. In response to the letter firm has submitted
stability data sheet specifying stability conditions as 30 ± 2 oc
and 65 ± 5%RH with same results at each time point.
Decision:
is not true
 Submission of original legalized and valid CoPP.
Evaluation by PEC:
unjustifiable/irrational as there is no difference in manufacturer of 3 batches conducted as per
assay values of initially submitted stability data (at 25 the conditions of zone IV-A. The data
± 2oc and 60 ± 5%RH) and the stability data submitted submitted is only for 6 months. The firm has
after issuance of letter (at 30 ± 2oc and 65 ± 5%RH). NOT submitted any clarification regarding
Since this ambiguity shows that the revised data (at 30 already submitted stability data sheets having
± 2oc and 65 ± 5%RH) is not true. same values at both conditions.
Evidence of approval status of the product in reference Firm has not submitted any reference
regulatory authorities in the applied strength.
Submission of original, legalized and valid CoPP Firm has submitted new CoPP which is valid
till 26-02-2020.

accessed
http://www.sfda.gov.cn/art/2017/12/20/art_8045
_782171.html
meeting
Variation in address mentioned on DSL and Form Firm has submitted revised Form 5A
5A. Clarify
Development Zone, Jining, Shandong Province China
Brand Name +Dosage Form + Docetaxel injection 20mg
Strength Freeze dried cake for solution for injection (Lyophilized powder)
Composition Each Vial (0.5ml) Contains:
Docetaxel…….20mg
(Monograph is present for sterile solution)
Shelf life 2 years
Pack size 1×1‘s
International availability DOCEFREZ lyophilized powder for injection (20mg/vial of 1ml,
80mg/vial of 4ml) by Ms/ Sun Pharmaceutical Ind. Ltd, USFDA
Approved.
Me-too status Docet 20mg/0.5ml injection by M/s Helix Pharma (IMPORTED)
(Reg # 072507)
Detail of certificates attached Original legalized CoPP (certificate No. 151100B0/62248)
issued by Jining Food and Drug Administration on 14/12/2015
confirms the free sale of the product in exporting country. The
facilities and operations conform to GMP as recommended by
WHO.
 The product is approved in USFDA as powder for injection
in 1ml vial while the firm has applied with for powder for
injection in 0.5ml vial. 1ml of the solvent is required for
reconstitution. (Ref USFDA) and 2mg/0.5ml injection is
approved in Health Canada as Solution for injection.
 The firm has claimed USP specifications while the
product is not present in USP/BP.
submitted stability data sheet specifying stability
conditions as 30 ± 2oc and 65 ± 5%RH with same results
at each time point.
(at 25 ± 2oC and 60 ± 5%RH) and the stability data submitted after issuance of letter (at 30 ± 2 oC
and 65 ± 5%RH). Since this ambiguity shows that the revised data (at 30 ± 2 oC and 65 ± 5%RH)
is not true
strength/volume.
Evaluation by PEC:
Submission of clarification regarding since the Firm has again submitted stability data with
data/assay values in the stability studies are protocol having condition 30 ± 2oC and 65 ±
unjustifiable/irrational as there is no difference in assay 5%RH and stability data with condition 25 ±
values of initially submitted stability data (at 25 ± 2 oc 2oC and 60 ± 5%RH. This data has been
and 60 ± 5%RH) and the stability data submitted after verified/stamped by Cisen Pharmaceuticals.
issuance of letter (at 30 ± 2oc and 65 ± 5%RH). Since The firm has NOT submitted any clarification
this ambiguity shows that the revised data (at 30 ± 2 oc regarding already submitted stability data
and 65 ± 5%RH) is not true. sheets having same values at both conditions.
Evidence of approval of the product inreference Docetaxel Actavis 20mg/0.5ml
regulatory authorities in the same strength/ volume. concentrate and solvent for solution for
infusionMHRA Approved.
The protocols of stability mentions conditions 30 Firm has submitted long term stability of 3 batches
± 2oC and 65 ± 5%RH whereas the stability data 1604051231, 1604051232, 1604051233. The
mentions the condition 25 ± 2oC and 60 ± batches were manufactured in April 2018 and the
5%RH. The data is same as submitted before firm has submitted stability data till 36 months
which should have been completed in April 2021
but the stability data sheets contains values for the
time points which are yet to come.
Clarifythe formulation whether lyophilized Concentrate
powder or concentrate
and Drug Administration which is not a state or of Shandong province food and drug administration,
provincial certifying authority. shandong province food and drug administration
authorize the city level food and drug
administration to issue CoPP. Since the
manufacturer M/s Cisen Pharmaceutical Co. Ltd. is
in Shandong province, therefore the city level
2171.html
Evidence of approval of applied formulation in Docetaxel Actavis 20mg/0.5ml concentrate
reference regulatory authorities which were and solvent for solution for infusionMHRA
approved by Registration Board in its 275th Approved.
meeting
Firm has claimed USP specification but impurity Firm has submitted that their docetaxel injection is
and endotoxin specification of USP are more according to CFDA standard, but the inner
stringent than provided specification. controlled parameter of impurity and endotoxin is
more strict than USP standard. The firm has also
compared USP standard limits with their inner
controlled standards.
Decision: Registration Board deferred the case for following submission:
 Clarification of the stability study data sheets which contains the results of 3 years stability
study data for batches manufactured in April 2018.
 Submission of original signed stability study data sheets along with complete results for
long term stability of 3 batches 1604051231, 1604051232 and 1604051233 which were
manufactured in April 2018.
Brand Name +Dosage Form + DOCETAXEL Injection 80 mg
Strength Freeze dried cake for solution for IV injection (lyophilized
Powder)
Composition Each Vial (2ml) Contains:
Docetaxel…….80mg
(Monograph is present for sterile solution)
Shelf life 3 years
Pack size 1×1‘s
International availability DOCEFREZ lyophilized powder for injection (20mg/vial of 1ml,
80mg/vial of 4ml) by Ms/ Sun Pharmaceutical Ind. Ltd, USFDA

Approved.
Me-too status Docet 80mg/2ml injection by M/s Helix Pharma (IMPORTED)
(Reg # 072508)
Detail of certificates attached Legalized copy and valid CoPP (certificate No.
171100B0/33636) issued by Jining Food and Drug
Administration on 05/06/2017 confirms the free sale of the
product in exporting country. The facilities and operations
 The product is approved in USFDA as powder for injection
in 4ml vial while the firm has applied with for powder for
injection in 2ml vial. 4ml of the solvent is required for
reconstitution. (Ref USFDA) and 80mg/2ml injection is
approved in HealthCanada as Solution for injection.
 The firm has claimed USP specifications while the
product is not present in USP/BP.
submitted stability data sheet specifying stability
conditions as 30 ± 2oc and 65 ± 5%RH with same results
at each time point.
is not true
 Finished product specifications.
Evaluation by PEC:
Submission of clarification regarding since the Firm has again submitted stability data with
data/assay values in the stability studies are protocol having condition 30 ± 2oC and 65 ±
unjustifiable/irrational as there is no difference in 5%RH and stability data with condition 25 ±
assay values of initially submitted stability data (at 25 2oC and 60 ± 5%RH. This data has been
± 2oc and 60 ± 5%RH) and the stability data verified/stamped by Cisen Pharmaceuticals.
submitted after issuance of letter (at 30 ± 2oc and 65 The firm has NOT submitted any clarification
± 5%RH). Since this ambiguity shows that the regarding already submitted stability data sheets
revised data (at 30 ± 2oc and 65 ± 5%RH) is not true. having same values at both conditions.
Evidence of approval of the product inreference Docetaxel Actavis 80mg/2ml concentrate
regulatory authorities in the same strength/volume. and solvent for solution for
infusionMHRA Approved.
The copy of CoPP has been provided Original, legalized CoPP was already available in the
dossier. The CoPP confirm the product as
80mg/1.5ml, while 7ml vials are mentioned in the
stability study data and the international reference
was also for 80mg/2ml.
The protocols of stability mentions conditions Firm has submitted long term stability of 3 batches
30 ± 2oC and 65 ± 5%RH whereas the stability 1608231231, 1608231232, 1608231233. The batches
data mentions the condition 25 ± 2oC and 60 ± were manufactured in August 2018 and the firm has
5%RH. The data is same as submitted before submitted stability data till 36 months which should
have been completed in August 2021 but the stability
data sheets contains values for the time points which
are yet to come.
The certifying authority for CoPP is Jinning Firm has submitted that ―as per the announcement of
Food and Drug Administration which is not a Shandong province food and drug administration,
state or provincial certifying authority. shandong province food and drug administration
authorize the city level food and drug administration
to issue CoPP. Since the manufacturer M/s Cisen
Pharmaceutical Co. Ltd. is in Shandong province,
therefore the city level Jinning food and drug
administration is authorized to issue CoPP. Firm has
also submitted following link but it could not be
accessed
171.html
Evidence of approval of applied formulation in Docetaxel Actavis 80mg/2ml concentrate
reference regulatory authorities which were MHRA Approved, but the product mentioned in
approved by Registration Board in its 275th CoPP is 80mg/1.5ml
meeting
Firm has claimed USP specification but Firm has submitted that their docetaxel injection is
impurity and endotoxin specification of USP according to CFDA standard, but the inner controlled
are more stringent than provided specification. parameter of impurity and endotoxin is more strict
than USP standard. The firm has also compared USP
standard limits with their inner controlled standards.
Decision: Registration Board deferred the case for following submission:
 Clarification of the stability study data sheets which contains the results of 3 years stability
study data for batches manufactured in August 2018.
 Submission of original signed stability study data sheets along with complete results for
long term stability of 3 batches 1608231231, 1608231232 and 1608231233 which were
manufactured in August 2018.
 Clarification regarding the fill volume, since the CoPP confirms that the product is
80mg/1.5ml, while in stability study data 7ml vials are mentioned. Furthermore the MHRA
approved reference product contains 80mg/2ml.
Name and address of manufacturer M/s Cisen Pharmaceutical Co. Ltd., Tongji Tech-Industry
Garden, Jining High & New Technology Ind. Development
Zone, Jining, Shandong Province, China.
Name and address of marketing M/s Cisen Pharmaceutical Co. Ltd., Tongji Tech-Industry
authorization holder Garden, Jining High & New Technology Ind. Development
Zone, Jining, Shandong Province, China. (as per CoPp and Sole
agency agreement)
Brand Name +Dosage Form + Oxaliplatin for injections 50mg
Strength Freeze dried cake for solution for IV injections (lyophilized)
Composition Each Vial Contains:
Oxaliplatin….. 50mg
Finished Product Specification In House
Shelf life 3 years
Pack size 1×1‘s (7ml glass vial)
International availability ELOXATIN for injection (50mg 100mg) by M/s SANOFI
AVENTIS US, USFDA approved
Me-too status Celdach 50 injection by Hakimsons (Reg # 72565) 64
Detail of certificates attached Original Legalized CoPP (certificate No. 151100B0/47076)
issued by Jining Food and Drug Administration on 16/09/2015 is
attached which confirms the free sale of the product in exporting
country. The facilities and operations conform to GMP as
recommended by WHO.
Remarks of the Evaluator.  The firm has claimed In House manufacturing specifications
while the product is available in USP. As per USP the
product contains Oxaliplatin and Lactose monohydrate while
according to formulation provided by the firm the product
contains Oxaliplatin and Mannitol.
conditions of zone IV-A. In response to the letter, firm has
point.
and 65 ± 5%RH). Since this ambiguity shows that the revised data (at 30 ± 2oc and 65 ± 5%RH)
is not true.
 Clarification regarding formulation since USP specifies the formulation containing Oxaliplatin
with Lactose monohydrate while submitted formulation by you contains Oxaliplatin and
Mannitol.
Evaluation by PEC:
unjustifiable/irrational as there is no difference in manufacturer of 3 batches 170610, 170611,
assay values of initially submitted stability data (at 170612 conducted as per the conditions of zone
25 ± 2oc and 60 ± 5%RH) and the stability data IV-A. The data submitted is only for 6 months.
submitted after issuance of letter (at 30 ± 2oc and 65 Additionally the impurities identified at various
± 5%RH). Since this ambiguity shows that the time points exceeds the limit identified in
revised data (at 30 ± 2oc and 65 ± 5%RH) is not acceptance criteria i.e. NMT 0.2%. The firm
true. has NOT submitted any clarification regarding
already submitted stability data sheets having
same values at both conditions.

Clarification regarding formulation since USP Firm has submitted that their principle
specifies the formulation containing Oxaliplatin manufacturer has informed that China FDA
with Lactose monohydrate while submitted does not approved lactose as excipient of
formulation by you contains Oxaliplatin and lyophilized powder instead they accept
Mannitol mannitol because it provides more stability.
accessed
782171.html
Evidence of approval of applied formulation in Eloxatin Injection 50mg by M/s Sanofi Aventis
reference regulatory authorities which were Inc USA. (USFDA Approved)
meeting
According to the specification of related substances Firm has submitted specifications of oxaliplatin
any individual impurity specs in NMT 0.2%. and comparison of its specs with USP and inner
However the results are greater than 0.2% i.e. out control standards but the firm has NOT
of specs, clarification is required. submitted justification of their results outside the
acceptance criteria.
 Scientific justification for out of specification impurities (i.e. results greater than 0.2%) while
the acceptance criteria was NLT 0.2%.
Name and address of manufacturer M/s Cisen Pharmaceutical Co. Ltd., Tongji Tech-Industry
Garden, Jining High & New Technology Ind. Development
Zone, Jining, Shandong Province, China.
Name and address of marketing M/s Cisen Pharmaceutical Co. Ltd., Tongji Tech-Industry
authorization holder Garden, Jining High & New Technology Ind. Development
Zone, Jining, Shandong Province, China. (as per CoPP and Sole
agency agreement)
(as per Sole Agency Agreement)
Brand Name +Dosage Form + OXALIPLATIN for injections 100mg
Strength Freeze dried cake for solution for IV injections (lyophilized)
Shelf life 3 years
Pack size 1×1‘s
International availability ELOXATIN for injection (50mg 100mg) by M/s SANOFI
AVENTIS US, USFDA approved
Me-too status Celdach 50 injection by Hakimsons (Reg # 72564)
Detail of certificates attached Original Legalized CoPP (certificate No. 151100B0/47077)
issued by Jining Food and Drug Administration on 16/09/2015 is
attached which confirms the free sale of the product in exporting
country. The facilities and operations conform to GMP as
recommended by WHO.
Remarks of the Evaluator.  The firm has claimed In House manufacturing specifications
product contains Oxaliplatin and Lactose monohydrate
while according to formulation provided by the firm the
product contains Oxaliplatin and Manitol.
point.
and 65 ± 5%RH). Since this ambiguity shows that the revised data (at 30 ± 2oc and 65 ± 5%RH)
is not true.
 Clarification regarding formulation since USP specifies the formulation containing Oxaliplatin
with Lactose monohydrate while submitted formulation by you contains Oxaliplatin and
Mannitol.
Evaluation by PEC:
unjustifiable/irrational as there is no difference in manufacturer of 3 batches 170613, 170614,
assay values of initially submitted stability data (at 170615 conducted as per the conditions of zone
25 ± 2oc and 60 ± 5%RH) and the stability data IV-A. The data submitted is only for 6 months.
submitted after issuance of letter (at 30 ± 2oc and 65 Additionally the impurities identified at various
± 5%RH). Since this ambiguity shows that the time points exceeds the limit identified in
revised data (at 30 ± 2oc and 65 ± 5%RH) is not true. acceptance criteria i.e. NMT 0.2%. The firm has
NOT submitted any clarification regarding
already submitted stability data sheets having
same values at both conditions.
Clarification regarding formulation since USP Firm has submitted that their principle
specifies the formulation containing Oxaliplatin with manufacturer has informed that China FDA does
Lactose monohydrate while submitted formulation not approved lactose as excipient of lyophilized
by you contains Oxaliplatin and Mannitol powder instead they accept mannitol because it
provides more stability.
and Drug Administration which is not a state or of Shandong province food and drug
provincial certifying authority. administration, shandong province food and drug
782171.html
Evidence of approval of applied formulation in Eloxatin Injection 100mg by M/s Sanofi Aventis
reference regulatory authorities which were Inc USA. (USFDA Approved)
meeting
According to the specification of related Firm has submitted specifications of oxaliplatin
substances any individual impurity specs in NMT and comparison of its specs with USP and inner
0.2%. However the results are greater than 0.2% control standards but the firm has NOT submitted
i.e. out of specs, clarification is required. justification of their results outside the acceptance
criteria.
 Scientific justification for out of specification impurities (i.e. results greater than 0.2%) while
the acceptance criteria was NLT 0.2%.
ii. Veterinary
466. Name and address of Applicant M/s Chakwal Pharma International, OTI Plaza, 210-Lalazar
commercial market, Thokar Niaz Baig, Raiwind Road Lahore.
Detail of Drug Sale License Address: OTI Plaza, 2nd floor 210-Lalazar commercial market,
Thokar Niaz Baig, Raiwind Road Lahore.
Status: License to sell drugs by way of wholesale
Name and address of Alfasan Nederland B.V. Kuipersweg 9, 3449 JA Woerden
manufacturer Netherlands
Name and address of marketing Alfasan Nederland B.V. Kuipersweg 9, 3449 JA Woerden
authorization holder Netherlands
Name of exporting country Netherlands

Brand Name +Dosage Form + Alfamec1% solution for injection
Strength
Ivermectin……..10mg
Finished Product Specification Firm has claimed inhouse specification while the finished product
monograph is available in BP/USP
Pharmacological Group Antiparasitic
Demanded Price Decontrolled
Pack size 100ml
International availability Netherland approved
Me-too status Ivoron Injection by Breeze Pharma (Reg # 059152)
Detail of certificates attached  Original, legalized CoPP (No. 247607) issued by Medicines
Evaluation Board Agency, Veterinary Medicinal Products Unit, and
Ministry of Economic Affairs, Netherlands dated 13 June 2017
confirms free sale status and GMP of the manufacturer.
 Copy of GMP certificate of M/s Alfasan International issued by
Medicine Evaluation Board dated 1 and 2 February 2017 is also
submitted.
 Copy of letter of exclusive sole distributor authorization dated 05-
05-2017 between M/s Alfasan International B.V and M/s Chakwal
Pharma International.
Firm was asked to clarify the following vide letter dated 4 th September 2018, The firm has now provided
following clarifications:
Shortcomings Reply of the firm
Clarification is required regarding the name of Firm has submitted original, legalized letter from
manufacturer since Form 5-A specify Alfasan Alfasan International stating that as per agreement
International as manufacturer, while the between Alfasan Nederland and Alfasan
manufacturer mentioned in CoPP is Alfasan International BV it is agreed that Alfasan
Nederland, and the GMP certificate submitted is International is allowed to export the product for
also of Alfasan International B.V. Furthermore which Alfasan Nederland BV is the registration
the sole agency agreement is with M/s Alfasan holder.
International B.V, which is product license Firm has further stated that Alfasan is a multilayer
holder in country of origin, justification in this group of companies all based in same physical
regard is also required. address. Alfasan Nederland is the full holding
company and registration holder of all products.
Alfasan International‘s factory inspected by Dutch
veterinary Authority is also based at the same
address, therefore the GMP certificate has been
issued in the name of Alfasan International.
Real time and accelerated stability study data of Firm has submitted data of 36 months of 3 batches
3 batches as per the conditions of Zone IV-A, conducted at 30oC and 65% RH.
since the submitted stability studies are
conducted at different conditions.
Firm has further submitted that their principle has performed stability studies as per BP monograph.
Decision of 288th meeting of Registration Board:
Deferred for revision of Form5A for manufacturer revised agreement with Marketing authorization
holder as per CoPP
Evaluation by PEC:
Firm has submitted revised Form 5-A with address of manufacturer as per CoPP and sole agency
agreement
Decision:Approved with BP specifications as per Policy for inspection of manufacturer abroad.

Detail of Drug Sale License Address: OTI Plaza, 2nd floor 210-Lalazar commercial market, Thokar
Niaz Baig, Raiwind Road Lahore.
Name and address of Alfasan Nederland B.V. Kuipersweg 9, 3449 JA Woerden Netherlands
manufacturer
Name and address of marketing Alfasan Nederland B.V. Kuipersweg 9, 3449 JA Woerden Netherlands
Brand Name +Dosage Form + Lincomycin-Spectinomycin 5/10 solution for injection
Strength
Composition Each ml solution contains:
Lincomycin (as hydrochloride)……..50mg
Spectinomycin (as hydrochloride)……….100mg
Finished Product Specification Firm has claimed in house specification and the finished product
monograph is not available in any pharmacopoeia.
Pharmacological Group Systemic antibiotics
Pack size 250ml vial
Me-too status Lincotin Injection by Star Labs (Reg # 025704)
Evaluation Board Agency, Veterinary Medicinal Products Unit,
submitted.
 Copy of letter of exclusive sole distributor authorization dated 05-05-
2017 between M/s Alfasan International B.V and M/s Chakwal
Clarification is required regarding the name Firm has submitted original, legalized letter from
of manufacturer since Form 5-A specify Alfasan International stating that as per agreement
Alfasan International as manufacturer, between Alfasan Nederland and Alfasan International
while the manufacturer mentioned in CoPP BV it is agreed that Alfasan International is allowed to
is Alfasan Nederland, and the GMP export the product for which Alfasan Nederland BV is
certificate submitted is also of Alfasan the registration holder.
International B.V. Furthermore the sole Firm has further stated that Alfasan is a multilayer group
agency agreement is with M/s Alfasan of companies all based in same physical address.
International B.V, which is product license Alfasan Nederland is the full holding company and
holder in country of origin, justification in registration holder of all products. Alfasan
this regard is also required. International‘s factory inspected by Dutch veterinary
Authority is also based at the same address, therefore the
GMP certificate has been issued in the name of Alfasan
International.

Real time and accelerated stability study Firm has submitted stability study data of 3 batches at
data of 3 batches as per the conditions of 30oC and 65% RH. The batches were manufactured in
Zone IV-A, since the submitted stability 2012.
studies are conducted at different
conditions.
holder as per CoPP
Evaluation by PEC:
agreement
Decision: Approved with Innovator‘s specifications as per Policy for inspection of manufacturer
abroad.
manufacturer
Type of Form Form 5-A;
Brand Name+Dosage Amoxycilline 20% LA suspension for injection
Form+Strength
Composition Each ml suspension contains:
Amoxycillin trihydrate………..200mg
monograph is available in USP/BP
Pharmacological Group Antibacterial for systemic use
Me-too status Novamox 20% LA Injection by Selmore
Ministry of Economic affairs, Netherlands dated 13 June 2017
submitted.
Real time and accelerated stability study data of Firm has submitted stability study data of 3 batches
3 batches as per the conditions of Zone IV-A, at 30oC and 65% RH.
Firm has submitted that the manufacturer has performed stability testing as per BP monograph
holder as per CoPP
Evaluation by PEC:
agreement
Decision:Approved with BP specifications as per Policy for inspection of manufacturer abroad.
manufacturer
Brand Name+Dosage Xylazine 2% solution for injection
Form+Strength
Xylazine (as hydrochloride)………..20mg
monograph is available in USP.
Pharmacological Group Hypnotics and sedatives
Pack size 30ml vial
Me-too status Xylaz Injection by Prix Pharma (Reg # 013246)

submitted.
International as manufacturer, while the between Alfasan Nederland and Alfasan International
manufacturer mentioned in CoPP is Alfasan BV it is agreed that Alfasan International is allowed to
Nederland, and the GMP certificate submitted export the product for which Alfasan Nederland BV is
is also of Alfasan International B.V. the registration holder.
Furthermore the sole agency agreement is Firm has further stated that Alfasan is a multilayer
with M/s Alfasan International B.V, which is group of companies all based in same physical
product license holder in country of origin, address. Alfasan Nederland is the full holding
justification in this regard is also required. company and registration holder of all products.
veterinary Authority is also based at the same address,
therefore the GMP certificate has been issued in the
name of Alfasan International.
Real time and accelerated stability study data Firm has submitted stability study data of 3 batches at
of 3 batches as per the conditions of Zone IV- 30oC and 65% RH.
A, since the submitted stability studies are
Firm has performed stability testing as per in house specification while the product monograph is also
available in USP. The difference in the specifications is provided in the table below:
Test Specification limit of the firm Limits specified by USP
pH 3.0 – 7.0 4.5 – 5.5
The stability data initially provided by the firm at zone II specified pH as 3.0 – 7.0, while the stability
data provided by the firm afterwards contains the limit of pH 5.0 – 6.0. The results of pH at all-time
points were within the USP limits.
holder as per CoPP
Evaluation by PEC:
agreement
Decision:Approved with USP specifications as per Policy for inspection of manufacturer abroad.
manufacturer
Brand Name+Dosage Multivitamin solution for injection
Form+Strength
Vitamin A…..15,000 IU
Cholecalciferol….1000 IU
Alfa-tocoferol acetate……20mg
Thiamine hydrochloride……10mg
Riboflavine sodium phosphate……6.85mg
Pyridoxine hydrochloride……..3mg
Cyanocobalamine………50 mcg
Nicotinamide……35mg
D-Panthenol……..25mg
monograph is not available in any pharmacopoeia.
Pharmacological Group Multivitamins
submitted.
Firm was asked to clarify the following vide letter dated 4th September 2018, The firm has now provided
Clarification is required regarding the name Firm has submitted original, legalized letter from
of manufacturer since Form 5-A specify Alfasan International stating that as per agreement
Alfasan International as manufacturer, between Alfasan Nederland and Alfasan International
while the manufacturer mentioned in CoPP BV it is agreed that Alfasan International is allowed to
is Alfasan Nederland, and the GMP export the product for which Alfasan Nederland BV is
certificate submitted is also of Alfasan the registration holder.
International B.V. Furthermore the sole Firm has further stated that Alfasan is a multilayer group
agency agreement is with M/s Alfasan of companies all based in same physical address. Alfasan
International B.V, which is product license Nederland is the full holding company and registration
holder in country of origin, justification in holder of all products. Alfasan International‘s factory
this regard is also required. inspected by Dutch veterinary Authority is also based at
the same address, therefore the GMP certificate has been
Real time and accelerated stability study Firm has submitted stability study data of 3 batches at
data of 3 batches as per the conditions of 30oC and 65% RH. The batches were manufactured in
Zone IV-A, since the submitted stability 2012.
studies are conducted at different
conditions.
Me-too status Firm has submitted following me-too
Multivor (Reg#048151) of ICI Pakistan
This me-too could NOT be confirmed since the claimed
me-too contains different strength of riboflavin and
cyanocobalamin
th
Decision of 288 meeting of Registration Board:
holder as per CoPP

Evaluation by PEC:
agreement.
The me-too status of this formulation could not be confirmed
Decision:Approved with innovator‘s specifications as per Policy for inspection of manufacturer
abroad.
manufacturer
Brand Name +Dosage Form + Tylosin 20% solution for injection
Strength
Tylosin (as tartrate)……..200mg
Finished Product Specification BP Specs
Pharmacological Group Macrolide
Pack size 100ml
Me-too status Tylowan 20 Injection by Nawan Pharma (Reg # 025356)
submitted.

Real time and accelerated stability study data of Firm has submitted data of 36 months of only 2
3 batches as per the conditions of Zone IV-A, batches conducted at 35oC and 65% RH
Deferred for the Submision of Long term stability studies conducted under the conditions of zone IV-A
of 1 batch till shelf life and revision of Form5A for manufacturer revised agreement with Marketting
authorization holder as per CoPP
Evaluation by PEC:
agreement.
Firm has not submitted stability study data of 3rd batch
Decision:Deferred for the Submission of long term stability studies conducted under the conditions
of zone IV-A of 3rdbatch till the complete shelf life.
Case No. 05: Registration applications of drugs for which stability study data is submitted
a. Deferred cases
Applicant Dosage Form + Date, Fee
Strength), (including GMP Inspection Report Date &
Composition, differential fee), Remarks
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
472. M/s Genix Pharma (Pvt) Carlep Tablets 200mg Form 5-D Aptiom Tablets by Sunovion
Ltd., 44, 45-B, Korangi Each tablet contains: Dy No. 351 Pharms (USFDA Approved)
Creek Road, Karachi Eslicarbazepine 14-3-2016
acetate……200mg PKR 50,000/- Last inspection report dated
(Anti-epileptic) (14-3-2016) 8.8.2017 confirms satisfactory
10‘s, 20‘s, 30‘s: compliance to GMP
Rs. 2250/ tablet
251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 17881 dated 15-5-2018)
Drug Carlep Tablets 200mg
Name of Manufacturer M/s Genix Pharma (Pvt) Ltd., 44, 45-B, Korangi Creek Road, Karachi
Manufacturer of API Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP Road, AT & Post
Karakhadi, Tal Padra, City Karakhadi, District: Vadodara Gujrat State,
India.
API Lot No. ECA/50010117
Description of Pack

Frequency Accelerated: 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 26 (Weeks)
Real Time: 0, 1, 2, 3, 4, 6, 8 (Months)
Batch No. TR001 TR002 TR003
No. of Batches 03
# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of Firm has submitted copy of GMP certificate of M/s
country of origin or GMP certificate of API Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP
manufacturer issued by regulatory authority of Road, AT & Post Karakhadi, Tal Padra, City
country of origin. Karakhadi, District: Vadodara Gujrat State, India.
Valid till 26-4-2019 issued by Food and Drugs
Control Administration Gujrat State India.
Yes
Yes
etc.
5. Documents confirming import of API etc. Firm has submitted ADC attested commercial
invoice dated 24-2-2017confirming import of 3 Kg
Eslicarbazepine acetate. The commercial invoice
contains the address of head office of the firm.
data / documents.
Yes
Yes
Rules, 1978.
Shortcoming communicated Response by the firm
Justify the partial mode of testing i.e. without Firm has submitted that they have performed stability studies
dissolution and assay at 1st and 3rd months in as per guidelines of Registration Board.
real time stability study data of all the three The guidelines of Registration Board in 251st meeting specify
batches. weekly testing intervals while firm has used monthly testing
intervals and claimed that they are following guidelines of
Registration Board.
Justify the specifications of dissolution (i.e. Firm has submitted that as per correspondence document by
NLT 80% of the labeled amount in 45 CDER ―it seems to be unacceptableof dissolution criteria Q
minutes) submitted under finished product at 15 minutes as mentioned‖. Firm has also provided a
specification, since the reference product reference link for this data
approved by USFDA Aptiom Tablets have https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/02
updated the dissolution specification for 200 2416Orig1s000AdminCorres.pdf

mg strength, to a single point Q* at 15
minutes since its dissolution profile was not- As per the details of the reference shared the exact
similar to the appropriate comparator as recommendations from FDA is ―Your proposal for a
specified in the executive summary of the dissolution acceptance criterion of Q= at 15 minutes for the
chemistry review for NDA 22416 (Ref: 200 mg tablets is not acceptable. Based on the provided data,
https://www.accessdata.fda.gov/drugsatfda_d a dissolution acceptance criterion of Q= at 15 minutes is
ocs/nda/2013/022416Orig1s000ChemR.pdf). appropriate. Nevertheless, it must be recognized that some
For elaboration on the value of ―Q‖ FDA in batches may require Stage 2 and, occasionally, Stage 3
its draft guidance for industry on dissolution testing. Revise you dissolution acceptance criterion for the
testing of immediate release solid oral 200 mg tablets from Q= at 15 minutes to Q at 15 minutes,
dosage forms under ―setting dissolution and submit a revised specifications table for the drug
specifications‖ have recommended ―for product.‖
highly soluble and rapidly dissolving drug Firm has submitted a reference of EDQM
products (BCS classes 1 and 3), a single- http://www.edqm.eu/en/Helpdesk-1683.html?rubrique=801
point dissolution test specification of NLT which specifies that in most of the cases Q can be 75% and
85% (Q=80%) in 60 minutes or less is overall dissolution limit can be 80% (Q+5).
sufficient as a routine quality control test for Since the reference product is FDA approved and upon
batch-to-batch uniformity‖ (Ref: approval the firm will be granted ―innovator‘s specification‖
https://www.fda.gov/downloads/drugs/guida therefore the guidelines of FDA should be implemented for
nces/ucm070237.pdf) this product.
Decision of previous meetings of Registration Board:
Registration Board after thorough discussion decided to reject the stability data on the basis of following
reasons:
 Adaptation of dissolution specification NLT 80% of the labeled amount in 45 minutes, while the FDA
approved reference product Aptiom tablets have used dissolution specifications NLT 85% in 15
minutes.
 Results of dissolution below 85% in 45 minutes at various time intervals.
 Registration Board further directed the firm to repeat the stability studies as per the recommendations
laid down in 278th meeting and finished product specifications as per the approved reference /
innovator product. (M-284)
Registration Board deferred the above cases of Carlep Tablets 200mg, 400mg and 800mg forfurther
deliberation. (M-286)
Registration Board after thorough discussion decided to defer the applications of Carlep
Tablets 200mg, 400mg and 800mg on the basis of following reasons:
 Adaptation of dissolution specification NLT 80% of the labeled amount in 45 minutes, while theFDA
approved reference product Aptiom tablets have used dissolution specifications NLT 85% in45 minutes.
 Results of dissolution below 85% in 45 minutes at various time intervals.(M-287)
Firm‘s Reply:
 Firm has referred tofollowing literature:
i. CDER review of reference product approved by USFDA which declares that BCS class of drug
Eslicarbazepine Acetate is not established while Eslicarbazepine Acetate has very low aqueous solubility.
ii. Following text from Section 6.1 (Immediate release dosage forms) of USP chapter <1092> (The
Dissolution Procedure; Development and Validation)
―Although release and stability data are collected during dosage form development, it is common to record
the entire dissolution profile or the amount of drug dissolved at specified intervals, such as 10, 20, 30, 40,
50, and 60 min or 15, 30, 45, and 60 min. At registration, dissolution for an immediate-release tablet
usually becomes a single-point test. The acceptance criterion and test time are established by evaluating
the dissolution profile data. The acceptance criterion for a dissolution test is a function of Q, which Is
expressed as a percentage of label claim of drug dissolved at a specified time. Typical Q values are in the
range of 75%-80% dissolved. Q values in excess of 80% are not generally used because allowance needs
to be made for assay and content uniformity ranges.‖
iii. Following text of a review article titled as ―Pharmacokinetics & Drug interactions of Eslicarbazepine
acetate‖:
―Therefore, Eslicarbazepine Acetate is a highly permeable-poorly soluble (BCS class II), drug, whereas
Eslicarbazepine is a highly soluble-highly permeable (BCS class I) drug.
 Moreover firm has submitted as under:

a. Practically we performed BCS class identification tests, material does not belong to BCS Class I.
b. Due to low solubility of drug dissolution limit Not less than 80% and as per USP General Chapter,
<1092> Q-values in the range of 75% to 80%.
Firm has submitted that they have performed dissolution as per FDA dissolution method and the time point is 45
minutes that was published on 27-8-2015 while the reference stated by PEC was published in 2013, so we
followed the later one. On the other hand if any product doesn‘t include in pharmacopoeia then we generally
follow USP<1092>, the acceptance criteria for a dissolution is a function of Q which is expressed as a
percentage of labeled of drug dissolved a specific time Q value in range of 75% to 80%.
Decision: Registration Board after thorough discussion decided to reject the application ―Carelp Tablet
200mg‖ on the basis of following reasons:
 Adaptation of dissolution specification NLT 80% of the labeled amount in 45 minutes, while the
FDA approved reference product Aptiom tablets have used dissolution specifications NLT 85% in
15 minutes.
Strength), Composition, differential fee), GMP Inspection Report Date
Pharmacological Demanded Price / & Remarks
Group, Pack size
Finished Product
Specification
473. M/s Genix Pharma (Pvt) Carlep Tablets 400mg Form 5-D Aptiom Tablets by Sunovion
Ltd., 44, 45-B, Korangi Each tablet contains: Dy No. 246 Pharms (USFDA Approved)
Creek Road, Karachi Eslicarbazepine 18-2-2016
acetate……400mg PKR 50,000/- Last inspection report dated
(Anti-epileptic) (18-2-2016) 8.8.2017 confirms satisfactory
10‘s, 20‘s, 30‘s: Rs compliance to GMP
2500 / tablet
(Dy.# 15519 dated 26-4-2018)
Manufacturer of API Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP Road, AT & Post
Karakhadi, Tal Padra, City Karakhadi, District: Vadodara Gujrat State,
India.
Description of Pack
Real Time: 0, 1, 2, 3, 4, 6, 8 (Months)

No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of country Firm has submitted copy of GMP certificate of M/s
of origin or GMP certificate of API manufacturer Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP
issued by regulatory authority of country of origin. Road, AT & Post Karakhadi, Tal Padra, City
Karakhadi, District: Vadodara Gujrat State, India.
Yes
invoice dated 24-2-2017 confirming import of 3
Kg Eslicarbazepine acetate. The commercial
invoice contains the address of head office of the
firm.
documents.
Yes
Yes
1978.
i. [

Justify the partial mode of testing i.e. without dissolution Firm has submitted that they have performed
and assay at 1st and 3rd months in real time stability study stability studies as per guidelines of Registration
data of all the three batches. Board.
The guidelines of Registration Board in 251st
meeting specify weekly testing intervals while
firm has used monthly testing intervals and
claimed that they are following guidelines of
Registration Board.
Justify the specifications of dissolution (i.e. NLT 80% of Firm has submitted a reference of EDQM
the labeled amount in 45 minutes) submitted under http://www.edqm.eu/en/Helpdesk-
finished product specification, since FDA in its draft 1683.html?rubrique=801 which specifies that in
guidance for industry on dissolution testing of immediate most of the cases Q can be 75% and overall
release solid oral dosage forms under ―setting dissolution dissolution limit can be 80% (Q+5).
specifications‖ have recommended ―for highly soluble Since the reference product is FDA approved and
and rapidly dissolving drug products (BCS classes 1 and upon approval the firm will be granted
3), a single-point dissolution test specification of NLT ―innovator‘s specification‖ therefore the
85% (Q=80%) in 60 minutes or less is sufficient as a guidelines of FDA should be implemented for
routine quality control test for batch-to-batch uniformity‖ this product.
(Ref:
https://www.fda.gov/downloads/drugs/guidances/ucm070
237.pdf).

reasons:
minutes.
 Results of dissolution below 85% in 45 minutes at various time intervals.(M-287)
Firm‘s Reply:
iv. CDER review of reference product approved by USFDA which declares that BCS class of drug
v. Following text from Section 6.1 (Immediate release dosage forms) of USP chapter <1092> (The
vi. Following text of a review article titled as ―Pharmacokinetics & Drug interactions of Eslicarbazepine
acetate‖:
c. Practically we performed BCS class identification tests, material does not belong to BCS Class I.
d. Due to low solubility of drug dissolution limit Not less than 80% and as per USP General Chapter,
45 minutes.

Specification
474. M/s Genix Pharma (Pvt) Carlep Tablets 800mg Form 5-D Aptiom Tablets by
Ltd., 44, 45-B, Korangi Each tablet contains: Dy No. 238 Sunovion Pharms (USFDA
Creek Road, Karachi Eslicarbazepine 18-2-2016 Approved)
acetate……800mg PKR 50,000/-
(Anti-epileptic) (18-2-2016) Last inspection report dated
10‘s, 20‘s, 30‘s: Rs 8.8.2017 confirms
3000/ tablet satisfactory compliance to
GMP
(Dy.# 15519 dated 26-4-2018)
Manufacturer of API Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP Road, AT & Post Karakhadi,
Tal Padra, City Karakhadi, District: Vadodara Gujrat State, India.
Description of Pack
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 0, 1, 2, 3, 4, 6, 8 (Months)
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of country Firm has submitted copy of GMP certificate of M/s
of origin or GMP certificate of API manufacturer Ami Lifesciences Pvt. Ltd., Block No. 82/B, ECP
issued by regulatory authority of country of origin. Road, AT & Post Karakhadi, Tal Padra, City
Karakhadi, District: Vadodara Gujrat State, India.
Yes
th
invoice dated 27-4-2017 confirming import of 7 Kg
Eslicarbazepine acetate. The commercial invoice
contains the address of head office of the firm.
documents.
Yes
Yes
1978.
ii.
Justify the partial mode of testing i.e. without Firm has submitted that they have performed
dissolution and assay at 1st and 3rd months in real time stability studies as per guidelines of Registration
stability study data of all the three batches. Board.
The guidelines of Registration Board in 251st
meeting specify weekly testing intervals while firm
has used monthly testing intervals and claimed that
they are following guidelines of Registration Board.
Justify the specifications of dissolution (i.e. NLT 80% Firm has submitted a reference of EDQM
of the labeled amount in 45 minutes) submitted under http://www.edqm.eu/en/Helpdesk-
finished product specification, since FDA in its draft 1683.html?rubrique=801 which specifies that in
guidance for industry on dissolution testing of most of the cases Q can be 75% and overall
immediate release solid oral dosage forms under dissolution limit can be 80% (Q+5).
―setting dissolution specifications‖ have Since the reference product is FDA approved and
recommended ―for highly soluble and rapidly upon approval the firm will be granted ―innovator‘s
dissolving drug products (BCS classes 1 and 3), a specification‖ therefore the guidelines of FDA
single-point dissolution test specification of NLT should be implemented for this product.
85% (Q=80%) in 60 minutes or less is sufficient as a
routine quality control test for batch-to-batch
uniformity‖ (Ref:
https://www.fda.gov/downloads/drugs/guidances/ucm
070237.pdf).
reasons:
minutes.
 Results of dissolution below 85% in 45 minutes at various time intervals. (M-287)

Firm‘s Reply:
vii. CDER review of reference product approved by USFDA which declares that BCS class of drug
viii. Following text from Section 6.1 (Immediate release dosage forms) of USP chapter <1092> (The
ix. Following text of a review article titled as ―Pharmacokinetics & Drug interactions of Eslicarbazepine
acetate‖:
e. Practically we performed BCS class identification tests, material does not belong to BCS Class I.
f. Due to low solubility of drug dissolution limit Not less than 80% and as per USP General Chapter,
45 minutes.
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Local Availability
Applicant Form + Strength), Date, Fee (including
Composition, differential fee), GMP Inspection Report
Finished Product Specification Pack size
475. M/s Hudson Pharma Brinzoson Eye Drops Form 5-D Simbrinza ophthalmic
(Pvt) Ltd., D-93, (Ophthalmic suspension) Dy No. 12980 suspension by Novartis
North Western Each ml contains: 06-04-2018 (USFDA Approved)
Industrial Zone Port Brinzolamide….10mg PKR 50,000/-
Qasim Karachi Brimonidine tartrate….2mg (22-01-2018) New section granted on
(Anti glaucoma preparation) (DUPLICATE) 11-04-2018
5ml: As per SRO
(Dy.# 14615 dated 19-4-2018)
Drug Brinzoson Eye Drops (Ophthalmic suspension)
Name of Manufacturer M/s Hudson Pharma (Pvt) Ltd., D-93, North Western Industrial Zone Port Qasim
Karachi

Manufacturer of API Brinzolamide: M/s ICROM S.P.A.,Via Delle Arti, 33–20863 Concorezzo (MB),
Italy
Brimonidine tartrate: M/s Symed Labs, Limited, Unit-II, Plot No. 25/B, Phase-
III. I.D.A., Jeedimetla, Hyderabad, Telangana, India
API Lot No. Brinzolamide: 001/16M
Brimonidine tartrate: 2SU0051016
Description of Pack
Eye drops bottle
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 1, 3, 6 (Months)
Batch No. 001 002 003
Batch Size 76 bottles 76 bottles 76 bottles
No. of Batches 03
1. COA of API Brinzolamide: Yes
Brimonidine tartrate: Yes
2. Approval of API by regulatory authority of country Brinzolamide: Firm has submitted copy of GMP
of origin or GMP certificate of API manufacturer certificate issued by AIFA, Italy issued on 15-02-
issued by regulatory authority of country of origin. 2017
Brimonidine tartrate: Firm has submitted copy of
GMP certificate issued by DCA, Govt. of
Telangana, India
Yes
5. Documents confirming import of API etc. Brinzolamide: Firm has submitted ADC attested
invoice dated 31-5-2017 confirming import of 20gm
API along with import of 200mg working standard.
Brimonidine tartrate: Firm has submitted ADC
attested invoice dated 20-6-2017 confirming import
of 0.1Kg API.
and stamp) for ensuring authenticity of data / No
documents.
7. Commitment to continue real time stability study
Yes
th
1978.
The stability data sheets of batch 001, 002 and 003 Firm has submitted that stability sheets were mainly
for 6th months accelerated conditions was signed developed for chemical analysis of product, separate
and approved on 15-02-2018 and 16-2-2018 stability sheets were filled with sterility completion.
respectively, while the report of sterility test for the Column for sterility will be left blank till completion
same was signed on 28-02-2018. Justify the of sterility and that will fill after completion of
development and approval of stability data sheets sterility. Now we are putting initial with date on
before the results of sterility test. product analysis sheet.
Justify the shifting of retention time of brimonidine Firm has submitted that finished product analytical
from 4.054 at 6th month testing to 5.27 at 3rd month method is not available in any pharmacopoeia it is in-
testing and brinzolamide from 7.07 at 6th month house method. Analytical method was on development
testing to 6.01 at 3rd month testing and 5.34 at 1st stage and now it is fully developed. With the passage
month testing interval. of time column efficiency is affected and retention
time depends on column efficiency. On every testing
frequency standard peak is comparable to sample peak.
Minor difference in retention time may appear due to
column efficiency.
Justify the formulation containing brimonidine as Firm has submitted that they have applied for the same
tartrate 2mg, since the USFDA approved reference formulation i.e. Brimonidine tartrate 2mg. Firm has
product contains brimonidine tartrate 2mg. submitted revised form 5-D.
The initially submitted form 5-D and master
formulation contains brimonidine as tartrate 2mg.
Justify the finished product specification without Firm has submitted that USP has not specified test for
benzalkonium chloride assay, osmolality, preservatives in any ophthalmic formulation. Similarly
redispersibility and viscosity since all these tests are the standard limits for viscosity and redispersibility are
included in the specifications of the USFDA not available therefore we will develop our own limits
approved reference product i.e. Simbrinza on commercial batches.
ophthalmic suspension.
Justify the manufacturing of batches of ophthalmic Firm has submitted that these stability batches were
suspension in August 2017, while the Eye / Ear & manufactured in R&D solution filling machine under
Nasal drop (General) section was approved by laminar. Before commercial manufacturing pilot
Central licensing Board vide letter No. F.2- batches will be manufactured and will be kept on
12/2010-Lic (Vol-I) dated 11th April 2018. stability.
Shortcomings after reply:
Justify the initiation and completion of stability studies Firm has submitted analytical method validation
without analytical method validation, since ICH data to justify the initiation of stability studies.
guidelines Q1A(R2): Stability testing of new drug The data provided by the firm is of January 2018,
substances and products specify that ―Analytical while the stability studies were initiated in
procedures should be fully validated and stability August 2017.
indicating‖.
The initially submitted master formulation dated 19-4- Firm has submitted Form 5-D, composition and
2018 contains brimonidine (as tartrate) 2mg, while in the manufacturing method of correct formulation.
reply you have mentioned that ―we have the same The newly submitted formulation contains
formulation and have submitted Form 5-D with different formulation as compared to initially
correction‖. Justification is required since the developed applied formulation.
formulation on which stability studies are conducted
contains brimonidine (as tartrate) 2mg. Further in case of
revision of formulation fee needs to be submitted.
As per ICH guidelines Q6A Specifications: Test Firm has once again submitted that USP has not
Procedures and Acceptance Criteria for New Drug specified test for preservatives in any ophthalmic
Substances and New Drug Products: Chemical formulation. Similarly the standard limits for

Substances and Q1A(R2): Stability testing of new drug viscosity and redispersibility are not available
substances and products, the testing should cover therefore we will develop our own limits on
preservative content and the acceptance criteria should commercial batches.
remain part of the specification. Further the guidelines Since after approval this product will be given
specify, for relatively viscous solutions or suspensions, it ―Innovator‘s specification‖ therefore this product
may be appropriate to include rheological properties should have been tested for all the tests specified
(viscosity/specific gravity) in the specification. by the innovator product.
Justification is required since these tests are not
performed at any testing interval.
 Further firm has used LDPE bottles for eye drops which is a semi permeable container. As per ICH
guidelines for drug products packaged in semi-permeable containers the testing conditions are:
Study Storage conditions
Long Term 30°C ± 2°C/35% RH ± 5% RH
Accelerated 40°C ± 2°C/not more than (NMT) 25% RH
Aqueous-based products packaged in semi-permeable containers should be evaluated for potential water
loss in addition to physical, chemical, biological, and microbiological stability.
Decision of 284th meeting of RB:
reasons:
 Manufacturing of batches of applied formulation i.e. ophthalmic suspension before the approval of
relevant section i.e. Eye / Ear & Nasal drops (General) by Licensing Division, DRAP.
Registration Board further directed the firm to repeat the stability studies as per the recommendations laid down
in 278th meeting.
Firm has submitted fresh application for the same product on Form 5-D dated 7th December 2018 along with fee
PKR 50,000/- dated 7th December 2018. Firm has submitted same stability study data which was previously
rejected.
Decision of 287th meeting of Registration:
Deferred for the opinion of Licensing Division upon following:
―Manufacturing of batches of applied formulation i.e. Cream before the approval of relevant section i.e. Eye /
Ear & Nasal drops (General) by Licensing Division, DRAP
Evaluation by PEC:
Firm has submitted that ―In lieu of the decision (3-4th January 2019, 287th meeting of registration board) made
by the Drug Regulatory Authority of Pakistan (DRAP) on Hudson Pharma's application for registration of
Combison and Brinzoson Eye Drops, Hudson Pharma would like to place a humble request for a stability audit.
The registration section rejected the stability studies on the aforementioned drugs based on the reason that the
stability testing was conducted before the approval of relevant section, i.e. Eye / Ear & Nasal drops. However,
we could not find the requirement of relevant section approval prior to stability studies approval in any written
DRAP regulations. The Copies of our earlier applications along with supporting documents and Board Decision
is annexed herewith for your ready reference and convenience.
Being aggrieved by and dissatisfied with the subject decision, we hereby submit the following grounds for
review and reconsideration of the Hon‘ble Board member:-
DRAP Laws:-
As far as the DRAP Act and Rules are concerned, we have gone through the relevant provisions and found
following relevant to our case:
a. Rule 21 of The Drug (Licensing, Registering and Labelling)Rules, 1976
For the sake of convenience, Rule 21 is reproduced as under:-
21. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for
experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such
manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to
its Secretary.
As we studied Rule 21 of The Drug Rules 1976, we could not find a requirement for section approval even for
the manufacture of drugs for experimental purposes in Form 3.
b. Rule 7 / Form 6 of The Drugs (Import & Export) Rules, 1976
Therefore, the only available option we had was to apply under Rule 7 of The Drugs (Import & Export) Rules,
1976. To obtain Form 6 for import of the APIs for Clinical Trail Examination, Test or Analysis.

Here again, there is no requirement of the Section Approval as per law and it only requires a valid Drug
Manufacturing License, which was provided and accordingly the license for import of APIs were allowed for
the subject purpose.
International Laws and Practices:
In addition to the above, we also conducted a comprehensive research to know about the international pharma
industry practices all over the world. The regulatory requirements for the filing of generic drug applications in
the USA and EU envisage that stability testing requirements precede the requirements for section approval.
According to the USFDA, the ANDA (Abbreviated New Drug Application) flowchart (Fig 1) depicts that
preapproval inspection (in DRAP terminology this would equate to a visit for section approval) is assessed only
after chemistry, micro and labelling review is approved. Based on the data that we have studied so far, we can
establish that among the major regulatory bodies across the globe, stability studies are done prior to receiving
section approval. In fact, in the US and EU, there are large Contract Research Organizations (CROs) that
provide outsourcing services for chemistry, biological and stability testing of drugs. Furthermore, in most
instances in the EU and US, the stability testing and chemistry review is done at the CRO‘s facilities which
implies that the manufacturing facility or section where the commercial product is manufactured will be
different than where the stability testing was conducted.
The explosive proliferation of CRO‘s and contract manufacturing organizations (CMO‘s) in China and India is
clear evidence that developing market regulators prioritize an efficient approval pathway that encourages
innovation and enable new treatments to quickly become available to address the unmet needs of their
respective local populations. The new drug approval process that is followed by all large regulatory bodies
across the globe has a major advantage of allowing the manufacturer to invest in a facility or section after
passing stability studies, biological analysis, chemical analysis, and labelling approval. The main advantage is
that it de-risks capital expenditures for drug manufacturers allowing for greater investment and innovation.
Therefore, in light of the data that we have gathered, we wish to extend our invitation to visit of our
manufacturing facility at the date and time of your convenience to ensure that the stability results,
manufacturing section, and overall facility standards meet your requirements for Combison and Brinzoson‖
Decision: Registration Board decided to seek comments of Legal Affairs and Licensing Divisions for
following clarification:
 Can manufacturing of trial batches of a product be carried out in a facility which is not yet
approved or licensed by Central Licensing Board?
b. VERIFICATION OF STABILITY STUDY DATA:

Sr. Name & Address Brand Name Type of Form, International Availability /
No. of Manufacturer / (Proprietary Name + Initial Diary & Local Availability
Applicant Dosage Form + Strength), Date, Fee (including
Composition, differential fee), GMP Inspection Report Date
Pharmacological Group, Demanded Price / & Remarks
Specification
476. The Searle Ticor 90mg Tablet Form 5-D Brilinta Tablets by Astra
company Limited Each film coated tablet Dy No. 23: Zaneca (USFDA Approved)
F-319 S.I.T.E contains: 13-3-2017
Karachi Ticagrelor…..90mg Rs. 50,000/- Last GMP inspection report
Anticoagulant/ antiplatelet 13-03-2017 dated 13-2-2018: Followup, as
agent As Per SRO per the data provided by
Mfg specs QALT Division.
251st meeting of Registration Board.Detailsof submitted data are as under:
(Dy.# 31206 dated 17-9-2018)
Drug Ticor 90mg Tablet
Name of Manufacturer The Searle company Limited F-319 S.I.T.E Karachi

Manufacturer of API M/s Alembic Pharmaceuticals Ltd. Vadodara Gujrat.
API Lot No. 1604000781
Description of Pack
Alu-Alu blister pack
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 17PD-305 17PD-306 18PD-010
Manufacturing Date December 2017 December 2017 January 2018
Date of Initiation January 2018 January 2018 January 2018
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of country of Firm has submitted GMP certificate of M/s
origin or GMP certificate of API manufacturer issued by Alembic Pharmaceuticals Ltd. Vadodara Gujrat
regulatory authority of country of origin. issued by Food and Drug control administration
Gujrat state India on 06-09-2018
Yes
details of tests.
5. Documents confirming import of API etc. Firm has submitted copy of ADC attested invoice
dated 12-01-2017 confirming import of 1.5kg
Ticagrelor from M/s Alembic Pharmaceuticals Ltd
6. All provided documents will be attested (name, sign and
Yes
Yes
As per FDA chemistry review, four polymorphic forms of ticagrelor have been identified, out of which one form
was used in all preclinical and clinical studies since it does not convert to any other form on storage. Verification
of the exact polymorphic form of ticagrelor is required.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Ticor
(Ticagrelor) 60mg & 90mg Tablets by M/s The Searle Company Limited, Karachi.
Investigation Date and Time: 11th March, 2019. (Forenoon)
Investigation Site: Factory premises of M/s The Searle Company Limited, Karachi.
Background:
Chairman Registration Board considered the applications of M/s. The Searle Company Limited, Karachi
for registration of Ticor (Ticagrelor) 60mg & 90mgTabletsand constituted a three-member panel to investigate
the authenticity / genuineness of data (import of raw material and stability data). Panel was advised to conduct
―Verification of polymorphic form of Ticagrelor as the FDA chemistry review mentions four polymorphic
forms and only one form is not converted into other form on storage‖
1. Dr. Rafeeq Alam, Meritorious Professor, Department of Pharmacology, University of Karachi, Karachi,
Member Registration Board.

Q.# QUESTION OBSERVATION BY PANEL
1. Do you have documents confirming the The firm has imported Ticagrelor raw material 1.5 Kg
import of Ticagrelor API including approval from M/s Alembic Pharmaceutical Limited, and got
from DRAP? approval from DRAP, Karachi.
2. What was the rationale behind selecting the The firm has implemented proper vendor evaluation
particular manufacturer of API? system. The rationale for the selection of this
manufacturer was availability of GMP certificate from
relevant authority, availability of DMF, working
standard, stability studies of API.
3. Do . you have documents confirming the The firm has imported working standard along with API
import of Ticagrelor reference standard and consignment. However, impurities testing is done on the
impurity standards? basis of RRT.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API, and working
API, reference standards and impurity standards provided by Alembic Pharmaceuticals Limited.
standards?
5. Do you have GMP certificate of API GMP certificate of API manufacturer issued by Food and
manufacturer issued by regulatory authority Drug Control Administration, Gujrat State, India.
of country of origin?
6. Do you use API manufacturer method of The firm has used API manufacturer‘s method of
testing for testing API? analysis for API testing.
7. Do you have stability studies reports on The firm has long term (3 years) and accelerated study (6
APIs? month) reports for Ticagrelor provided by Alembic
Pharmaceutical Limited.
8. If yes, whether the stability testing has been The stability testing is as per SIM as Impurity profile has
performed as per SIM method and been reported in stability study report of Ticagrelor
degradation products have been quantified? provided by M/S Alembic Pharmaceutical Limited.
9. Do you have method for quantifying the The firm had API manufacturer method for quantification
impurities in the API? of impurities in the API and the firm had quantified the
impurities on the basis of RRT and impurities are under
procurement for further confirmation.
10. Do you have some remaining quantities of The firm has 0.208 Kg of API Ticagrelor.
the API, its reference standard and impurities
standards?

11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients i.e.
excipients? hydroxyl propyl cellolose, Mannitol, Di basic calcium
phosphate, sodium starch glycolate, Magnesium stearate.
12. Do you have documents confirming the The firm has necessary documents confirming the import
import of the used excipients? of the used excipients.
13. Do you have test reports and other records on The firm has necessary test reports and other record for
the excipients used? the excipients used.
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of Ticagrelor development of Ticagrelor Tablets 90mg & 60mg.
Tablets Range?
15. Have you performed Drug-excipient The firm has used same excipient as used by the
compatibility studies? innovator (Brilinta / Brilique of AstraZeneca), therefore,
compatibility studies were not performed.
16. Have you performed comparative dissolution The firm has performed comparative dissolution studies
studies? on Ticagrelor Tablets 90mg against Brilique Tablets
90mg having lot no. TERR and Ticagrelor Tablet 60 mg
against Brilinta Tablets 60mg having lot no. KAGN,
manufactured by AstraZeneca with comparable results.
17. Do you have product development (R&D) The firm has dedicated product development (R&D)
section. section with requisite manufacturing & analysis facilities.
18. Do you have necessary equipment available The firm has necessary equipment available in product
in product development section for development section for development of the Ticagrelor
development of Ticagrelor Tablets Range? tablets.
19. Are the equipment in product development The equipment in product development section are
section qualified? qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-
calibration / re-qualification program for the qualification program for the equipment used in PD
equipment used in PD section? section.
21. Do you have qualified staff in product The firm had qualified staff comprising of 24 members in
development section with proper knowledge R&D department.
and training in product development?
22. Have you manufactured three stability The firm has manufactured three stability batches of each
batches for the stability studies of Ticagrelor strength forstability studies;
Tablets Range required? 1. Ticagrelor Tablets 90mg Batch numbers are
17PD-305, 17PD-306&18PD-010having batch
size 2500 tablets each.
2. Ticagrelor Tablets 60mg Batch numbers are
18PD-017, 18PD-018 & 18PD-019 having batch
size 2500 tablets each.
23. Do you have any criteria for fixing the batch The firm had informed that their criteria for fixing batch
size of stability batches? size is based on number of samples required for stability
studies for all testing frequencies.
24. Do you have complete record of production The firm has complete record of production of stability
of stability batches? batches.
25. Do you have protocols for stability testing of The firm has detailed protocols for stability testing of
stability batches? stability batches.
26. Do you have developed and validated the The firm has developed and validated the method of
method for testing of stability batches? testing for finished product.
27. Do you have method transfer studies in case Not applicable
when the method of testing being used by
your firm is given by any other lab?
28. Do you have documents confirming the The firm has proper documents confirming the
qualification of equipment / instruments qualification of equipment / instruments being used in the
being used in the test and analysis of test and analysis of Ticagrelor Tablets 90mg & 60mg
Ticagrelor Tablets Range and the finished API and the finished drug.
drug?
29. Do your method of analysis stability The firm used stability indicating method for the
indicating? quantification of any impurities and degradation products
in the tablets kept on stability testing.
30. Do your HPLC software 21CFR Compliant? The HPLC software is 21CFR Compliant as per record
available with the firm. The firm has Water‘s Alliance
2695 with Empower 3 software.
31. Can you show Audit trail reports on Audit trail on the testing reports is available.
Ticagrelor Tablets Range testing?
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches
degradation products and stability batches? only.
33. Do you have stability batches kept on The firm has completed accelerated stability testing on
stability testing? three stability batchesof each strength. Currently 12th
month real time stability testing has been completed with
satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the equipment
equipment used in Ticagrelor Tablets Range used in Ticagrelor Tablet Range for production and
production and analysis? analysis.
35. Do proper and continuous monitoring and Firm has software for monitoring of stability chambers.
control are available for stability chamber?
36. Do related manufacturing area, equipment, Related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities were GMP compliant.
compliant?
37. Any Other query raised by PER Division: The firm has procured polymorphic form II, the same has
Verification of polymorphic form of been confirmed by comparing the XRD results of
Ticagrelor as the FDA chemistry review manufacturer and a patent available WO2013/079589
mentions four polymorphic forms and only A1, The API manufacturer has provided declaration of
one form is not converted into other form on polymorphic form II and they have also obtained market
storage authorization from USFDA conditionally with expiration
of patent, which also shows the polymorphic form II is
accepted by USFDA.
Conclusions:
for registration of Ticor 60mg & 90mg Tablets (Ticagrelor) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are compliant and are suited for the
manufacturing of Ticor 60mg & 90mg Tablets.
Recommendations:
1. The firm may kindly be granted necessary registration of Ticor 60mg & 90mg tablets.
2. Since Ticagrelor falls in BCS Class IV (Low solubility and low permeability), therefore requires
Bioequivalence Studies. Therefore, post-registration bioequivalence studies are also recommended.
Note: The firm has submitted written commitment vide letter No. NIL dated 11 th March, 2019 for bioequivalence
studies on Ticor tablets
Decision: Registration Board decided to approve registration of ―Ticor (Ticagrelor) 60mg & Ticor
(Ticagrelor)90mg Tablets with Innovator‘s specifications by M/s The Searle Company Limited, Karachi.
Manufacturer will place first three production batches of both products on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Sr. Name & Address Brand Name Type of Form, International Availability /
No. of Manufacturer / (Proprietary Name + Initial Diary & Date, Local Availability
Applicant Dosage Form + Strength), Fee (including
Pharmacological Group, Demanded Price / & Remarks
Specification
477. M/s Global Velcure Plus Tablet Form 5-D Epclusa Tablets by Gilead
Pharmaceuticals Each film coated tablet Dy No. 15519 Sciences
(Pvt) Ltd., Plot # contains: 26-04-2018 (USFDA Approved)
204-205, Industrial Sofosbuvir…..400mg PKR 50,000/-

Triangle Kahuta Velpatasvir co-povidone eq. (24-7-2018)
Road, Islamabad. to velpatasvir….100mg 28‘s: As per SRO
(Anti-viral)
251st meeting of Registration Board.Detailsof submitted data are as under:
(Dy.# 15519 dated 26-4-2018)
Drug Velcure Plus Tablet
Name of Manufacturer M/s Global Pharmaceuticals (Pvt) Ltd., Plot # 204-205, Industrial Triangle Kahuta
Road, Islamabad.
Manufacturer of API Sofosbuvir:M/s Suli Pharmaceutical Technology Jiangyin Co Ltd., No. 2 Runhua
Road, Harbour Economic Development District, Jiangyin, Jiangsu Province China
Velpatasvir:M/s Nantong Chanyoo Pharmatech Co. Ltd., No. 2 Tonghai Si Road,
Yangkou Chemical Industrial Park, Rudong Coastal Economic Development Zone,
Nantong, Jiangsu Province.
API Lot No. Sofosbuvir:SLZY059-Form6-17060101
Velpatasvir:201703002
Description of Pack
HDPE Bottles with child resistant closure
Real Time: 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 26 (Weeks)
Batch No. T-035(Q) T-036(Q) T-037(Q)
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of country of Sofosbuvir: Firm has submitted GMP certificate of
origin or GMP certificate of API manufacturer issued M/s Suli Pharmaceutical Technology issued by
by regulatory authority of country of origin. Jiangsu Changzhou Drug Administration
Velpatasvir: Firm has submitted copy of GMP
certificate issued by Nantong Food and Drug
Administration.
Copy of ―Certificate of GMP Compliance of a
Manufacturer‖ issued by ―Agency for medicinal
products and medical devices of the Republic of
Solvenia‖ for the M/s Nantong Chanyoo Pharmatech
Co.Ltd verified from following website link of
European Inspections database, when visited on 18-
10-32016:
http://eudragmdp.ema.europa.eu/inspections/gmpc/s
earchGMPCompliance.do?ctrl=searchGMPCResult
ControlList&action=Drilldown&param=28517 has
been verified.
Yes
5. Documents confirming import of API etc. Sofosbuvir: Firm has submitted ADC attested
invoice on 19-6-2017 confirming import of 100Kg
sofosbuvir. The ADC attested invoice is for already
registered Cure-C tablet.
Velpatasvir: Firm has submitted ADC attested
invoice dated 21-4-2017 confirming import of 1 Kg
velpatasvir copovidone.
documents.
Yes
Yes
1978.
Observations Reply by the firm
Justify the submitted specification of dissolution The firm has replied that ―we have not found any
test under the ―finished product specification‖ specific guidelines in this regard so we adopted this
specify the limit as NLT 75% (Q+5%), while as per value i.e. NLT 75% (Q+5%) at 30 minutes. We can
―Guidance for Industry, Dissolution testing of change our specification limits to NLT 80% on your
Immediate Release Solid Oral Dosage Forms‖ suggestion. Firm has further stated that DRAP has
issued by USFDA, a single-point dissolution test already approved same combination with 80%
specification of NLT 85% (Q=80%) in 60 minutes dissolution for some companies.
or less is sufficient as a routine quality control test
for batch-to-batch uniformity.‖
GMP certificate of the API manufacturer issued by Firm has submitted that the supplier of sofosbuvir i.e.
concerned regulatory authority of China, since the M/s Suli Pharmaceutical Technology Jiangyin Co Ltd
submitted copy of GMP certificate is issued by is our DRAP approved source in case of ―Cure-C
district regulatory authority, while as per Drug Tablet‖. That‘s why we have used the same source in
Administration Law of the People‗s Republic of this product as well.
China, Chapter-I General Provisions; Article 5 as Firm in its later reply submitted that their API was
discussed in 274th meeting of Registration Board manufactured by Jiangsu Yongda instead of Suli
―The drug regulatory department of the people‗s Pharma which is only a supplier in this case. The
government at or above the provincial level shall response of the firm was sent to AD (I&E) Islamabad
organize inspections of drug manufacturers in office for verification of the stance of the firm.
accordance with the Good Manufacturing Practice AD (I&E) office vide their letter No. F.4-15/2018-
for Pharmaceutical Products (GMP) and the I&E/QA&LT dated 15th November 2018 submitted the
measures and schedule for implementing the GMP copies of Form 3, Form 5 and Form 7. Form 5 (License
formulated by the drug regulatory department under to Import drugs) confirm that the material is
the State Council, and issue a certificate to the manufactured by Suli Pharma China, While Form 3 and
manufacturer that complies with the GMP‖ Form 7 confirms that the manufacturer is Jiangsu
Yongda Pharma, China.
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Velcure Plus
(Velpatasvir…..100 mg + Sofosbuvir……400 mg) Tablets by M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot
No. 204-205, Industrial Estate Triangle, Kahuta Road, Model Town, Islamabad.

Inspection Date and Time: 08th (Morning) and 27th February 2019 (Afternoon)
Inspection Site: M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Estate Triangle,
Kahuta Road, Model Town, Islamabad.
Background:
M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Estate Triangle, Kahuta Road, Model
Town, Islamabad applied for registration of Velcure Plus (Velpatasvir…..100 mg + Sofosbuvir……400 mg)
Tablets with following composition:
Velcure Plus Tablets

Each film coated tablet contains:-
Sofosbuvir…………..400 mg
Velpatasvir copovidone eq. to Velpatasvir………...100 mg
Chairman Registration Board constituted following three member panel for on-site investigation to
confirm the genuineness/authenticity of submitted stability data and associated documents, import of API,
quality, specification, test analysis, facilities etc. Panel was requested to conduct inspection of the firm to verify
the submitted data by the firm and to submit a report on approved format for further consideration of case by the
Registration Board.
1. Additional Director, QA & LT, DRAP, Islamabad.
2. Area FID, Islamabad.
3. Mr. Arsalan Tariq, Assistant Director, QA & LT, DRAP, Islamabad.
Scope of Inspection:
On-site investigation to confirm the genuineness/authenticity of submitted stability data and associated
documents, import of API, quality, specification, test analysis, facilities.
Tools for Inspection:

The Inspection was conducted by using a structured questionnaire approved by DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used and retained,
personnel involved, ongoing studies, printed data and integrity and security of data in respective databases were
also audited. The details of findings/verification inspection are summarized as under:
Detail of Inspection:
Q.
No.
1. Do you have documents Sofosbuvir
confirming the import of Invoice Number: 17SLZY023
API including approval from ADC attestation date: 19.06.2017
DRAP? Exporter: M/s Suli Pharmaceuticals Technology Jiangyin Co. LTD. No.2
Runhua Raod Harbour Economic Development District, Jiangyin Jiangsu
Province, China 214444.
Manufacturer: M/s Jiangsu Yongda Pharmaceutical Co. Ltd. No.05
Guangqu Road, New North Area, Changzhou, Jiangsu, China, 213001.
Batch No. SLZY059
Manufacturing Date: 29.04.2017
Retest Date: 28.04.2018
Quantity: 100 kg (The quantity was already in use in manufacturing of
commercial batches of registered product Cure-C (Sofosbuvir) 400 mg
Tablet).
Velpatasvir Copovidone
Invoice Number: CY117070
ADC attestation date: 21-04-2017
Exporter: M/s Changzhou Pharmaceutical Factory., 518 Laodong, East
road, Changzhou Jiangsu Province, China
Manufacturer: M/s Nantong Chanyoo Pharmatect Co. Ltd. China No. 2,
Tonghai Si Road, Yangkou Chemical Industrial Park, Rudong Coastal

Economic Development Zone, Nantong, Jiangsu Province 226407, P.R.
China
Batch No. 201703002
Mfg. Date: 16-03-2017
Exp. Date: 15-03-2018
Quantity: 01kg
2. What was the rationale Sofosbuvir
behind selecting the The firm has submitted that M/s Jiangsu Yongda Pharmaceutical Co. Ltd. is
particular manufacturer of their regular supplier and has Valid GMP; Client List of API manufacture
API? contains International and Local clients, Stability Data (Accelerated and
Real Time).
The firm has submitted a comparison sheet showing different parameters to
compare among 3 different sources API. M/S Nantong was selected on the
basis of Valid GMP, good impurity profile, previous history of Antiviral
manufacturing and good Client List of API manufacture contains
International and Local client. The firm has already used the ―Daclatasvir‖
from the same suppliers.
The selection of vendor was discussed in detail in the light of GMP
guidelines and firm was advised to devise an S.O.P for the purpose. There
should be a detailed report/study for such prequalification studies.
3. Do you have documents The firm imported following reference standards:
confirming the import of Sofosbuvir:
Sofosbuvir and velpatasvir Name of Source Batch No. Qua Invoi Mfg. Exp.
copovidone reference product ntity ce date date
standard and impurity No.
standards? Impurity M/s Suli SLZY059 1 gm - 24.05. 24.05.
Standard Pharmaceutical B- 17 18
SFBA-1 Technology via 1701001
Nimbus
Chemtech
The firm has developed tertiary working standard of Sofosbuvir from
secondary standards B.No.WS59-141001-Form6 provided by the
Manufacturer/source for Sofosbuvir.
Velpatasvir Copovidone:
Firm has imported Working Standard and impurities as per details below:
Name of Source Batch Quan Invoic Mfg. Exp.
product No. tity e No. date date
Velpatasv M/s Nantong WS20 1 gm CY11 15.10. 14.10.
ir Chanyoo Pharmatect 16100 7070 16 17
Working Co. Ltd. China via 01 A
Standard Changzhou
Pharmaceutical,
Factory, China.
Dihydrog As above WVL 100 As 10.11. 09.11.

en of VLP P0161 mg above 16 17
101
VLP-10 As above WVL 100 As 05.12. 04.12.
P0416 mg above 16 17
1201
VLP-11 As above WVL 100 As 10.12. 09.12.
1201
VLP-C As above WVL 100 As 17.12. 16.12.
1201

The firm again imported the following reference standards on 12.10.2017 as
per details below:
Name of Source Batch Quan Invoice Mfg. Exp.
product No. tity No. date date
Velpatasvir M/s Nantong WS20 1 gm - 05.10.17 04.10.18
Working Chanyoo Pharmatect 17100
Standard Co. Ltd. China via 01
Neon Chemicals
Dihydroge As above 20170 30 As 10.06.17 09.06.18
n of VLP 7001 mg above
VLP-10 As above 20170 30 As 04.07.17 03.07.18
7001 mg above
VLP-11 As above 20170 30 As 07.07.17 06.07.18
7001 mg above
VLP-C As above 20170 30 As 06.07.17 05.07.18
7001 mg above
* M/s Nantong Chanyoo Pharmatect Co. Ltd. China No. 2, Tonghai Si
Road, Yangkou Chemical Industrial Park, Rudong Coastal Econimic
Development Zone, Nantong, Jiangsu Province 226407, P.R. China.
4. Do you have certificate of The firm has submitted COAs of following drugs (APIs)/materials of source
Analysis of the API, as mentioned below:
reference standards and Sofosbuvir
impurity standards?  Sofosubuvir (API) B.No.SLZY059-Form6-17060101
 Sofosubuvir reference standard B.No.WS59-141001-Form6
 Impurity Standard SFBA-1 from the Source/Manufacturer (Batch No.
SLZY059B-1701001).
 Velpatasvir Copovidone (API)
 Velpatasvir Working Standard from the Source/Manufacturer
 Impurity Standard Dihydrogen of VLP
 Impurity Standard VLP-10
 Impurity Standard VLP-11
 Impurity Standard VLP-C
5. Do you have GMP Sofosbuvir
certificate of API The firm has submitted copy of GMP certificate No: JS20150406 in the
manufacturer issued by name of Manufacturer that is ―M/s Jiangsu Yongda Pharmaceutical Co. Ltd.
regulatory authority of No.05 Gangqu Road, chunjiang town, New North Area, Changzhou,
country of origin? Jiangsu, China,‖ of Sofosbuvir by the Certifying Authority of ―Jiangsu
Food & Drugs Administration, China.‖
Issued on: 30-03-2015
Valid upto: 29-03-2020
The firm has submitted copy of GMP certificate No: 2017006 in the name
of Manufacturer that is ―M/s Nantong Chanyoo Pharmatech Co. Ltd. No. 2,
Tonghai Si Road, Yangkou Chemical Industrial Park, Rudong Coastal
Econimic Development Zone, Nantong, Jiangsu Province 226407, P.R.
China for source of Velpatasvir Copovidone by the Certifying Authority
of ―Nantong Food & Drugs Administration (China)‖
Issued on: 08-09-2017
Valid upto: 07-09-2020
6. Do you use API The firm has used method of testing for testing API Sofosbuvir &
manufacturer method of Velpatasvir Copovidone provided from their respective manufacturers.
testing for testing API?

7. Do you have stability studies Sofosbuvir:
reports on API? Firm has submitted data of accelerated stability studies data of three batches
SLZY059-150102-Form 6 (Mfg.: 08th Feb, 2015), SLZY059-150401-Form
6 (Mfg: 04th Apr, 2015), & SLZY059-150501-Form 6 (Mfg:01st June,
2015), up to 6 months and for real time data up to 36 month, conducted by
the API manufacturer ―M/s Suli Pharmaceuticals Technology Jiangyin Co.
LTD. No.2 Runhua Raod Harbour Economic Development District,
Jiangyin Jiangsu Province, China 214444 for API namely Sofosbuvir .The
data submitted by the API manufacturers lies within the limits for the assay,
water & impurities.
Velpatasvir Copovidone:
Firm has submitted data of three batches 201611001 (Mfg.: 07 th Nov,
2016), 201611002 (Mfg.: 15th Nov, 2016), & 201611003 (Mfg.: 23rd Nov,
2016), for accelerated stability studies up to 6 months and for real time data
up to 24 month, conducted by the API manufacturer ―M/s Nantong
Chanyoo Pharmatech Co. Ltd. China No. 2, Tonghai Si Road, Yangkou
Chemical Industrial Park, Rudong Coastal Economic Development Zone,
Nantong, Jiangsu Province 226407, P.R. China for API namely Velpatasvir
Copovidone.The data submitted by the API manufacturers lies within the
limits for the Assay water & impurities.
8. If yes, whether the stability The firm has submitted the stability testing studies of the API the
testing has been performed determination of impurities, degradation products (as per definition of
as per SIM method and SIM).
degradation products have
been quantified?
9. Do you have method for The firm stated that they have used the vendor provided methods for
quantifying the impurities in quantifying the impurities in the API Sofosubvir and velpatasvir.
the API?
10. Do you have some The firm has submitted remaining quantities of the API, reference standard
remaining quantities of the and impurities standards as per details below:
API, its reference standard
and impurities standards?
11. Have you used The firm has used pharmaceutical grade excipients as indicated from the
pharmaceutical grade COAs submitted by firm.
excipients?

12. Do you have documents The firm purchased the excipients used in the applied formulation from
confirming the import of the local suppliers as per details below:
used excipients?
PHARMACOLGOCAL
S.No ITEM NAME
NATURE
1 Avicel 102 Excipient
2 Crosscarmellose Excipient
Sodium
3 Magnesium Stearate Excipient
4 Tabcoat white Excipient
5 Tabcoat orange Excipient
13. Do you have test reports and The firm has performed tests on above mentioned excipients and hence has
other records on the test reports and other records on the excipients used.
excipients used?
14. Do you have written and The firm has written and authorized protocols for the development of
authorized protocols for the Velcure Plus Tablet. But submitted documented was not in accordance with
development of Velcure Plus ICH Q-8 which actually pertains to Pharmaceutical Development. The firm
tablets 400/100mg was advised to improve the submitted protocol in the light of said
(Velpatasvir + document.
Sofosbuvir)?
15. Have you performed Drug- The firm has not performed Drug-Excipients compatibility studies as their
excipients compatibility formulation (API & Excipients) is similar/comparable to that of the
studies? EPCLUSA Tablet approved by EMA.
16. Have you performed The firm has performed comparative dissolution studies against the
comparative dissolution EPCLUSA Tablet (B# YPPGD1) approved by EMA. However, the studies
studies? seem improvement for example the firm has used 6 units for both test and
reference products instead of 12 as recommended in USFDA Guidance for
Industry: Dissolution testing of immediate release solid oral dosage form.
17. Do you have product The firm possesses an approved Research & Development (R&D) and
development (R&D) section Validation Department for product development studies.
18. Do you have necessary The firm has following necessary equipment in R & D section though for
equipment available in the development of Velcure Plus Tablet.
product development section
for development of Velcure
Plus tablets?
19. Are the equipment in The equipment used in production and analysis of trial batches are qualified
product development section as per details mentioned in reply of above question # 18.
qualified?
20. Do you have proper The firm has calibration program for the equipment used in production and
maintenance/calibration/re- QC as per details mentioned in reply of question 18.
qualification program for the

equipment used in PD
section?
21. Do you have qualified staff The firm has appointed a team of following technical personnel:
in product development
section with proper Sr. Employee Name Designation Qualification Experienc
knowledge and training in #. e
product development? 1. Mr. Muhammad Manager M. Sc. Analytical 17 years
Jamil R&D Chemistry
2. Dr. Tanseer Abbas Executive Pharm -D 06
Years
3. Atif Ali Executive M. Sc. Chemistry 5 years
4. Dr. Anas Ullah Senior analyst Pharm D 4.5 years
5. Muhammad Analyst M. Sc. Chemistry 1.5
Zubair Years
6. Miss Kainat Zahra Pharmacist Pharm D 06
month
22. Have you manufactured The firm has manufactured following three stability batches for the stability
three stability batches for the studies of Velcure Plus Tablet:
stability studies of Velcue S. No. Stability Batchs Batch Sizes
Plus tablets? a. T-035Q 1500 tablets
b. T-036Q 1500 tablets
c. T-037Q 1500 tablets
23. Do you have any criteria for The firm has set the criteria for fixing the batch size of stability batches
fixing the batch size of as/& derived the quantity sufficient for the studies both in accelerated and
stability batches? real time studies to cover all testing time points as per details below:
Tablets for
Batch Tablets for real Total packs per
S# accelerated
Sizes time studies batch required
studies
448 Tablets 336 Tablets 784 Tablets
1500
a OR OR OR
tablets
16 Packs 12 Packs 28 Packs
Batch size = 1500 Tablets, Pack Size 28‘S
24. Do you have complete The firm has complete record of production of stability batches. Starting
record of production of from Raw Material manufacturing order sheet assuring the traceability of
stability batches? manufacturing and analysis of all the three stability batches.
25. Do you have protocols for The firm has controlled protocol for testing of stability batches of applied
stability testing of stability formulation at 30 Co+ 2 Co & 65 % RH + 5 % with them for real time
batches? studies and at 40 Co+ 2 Co & 75 % RH + 5 % for accelerated studies.
26. Do you have developed and The firm has used Pharmacopoeial (B.P) method for testing of finished drug
validated the method for in their stability studies. The firm has also submitted a report verifying the
testing of stability batches? validation studies of the analytical method covering following parameters
of validation:
i. Specificity
ii. Precision
a. Repeatability
b. Intermediate Precision
iii. Accuracy
iv. Linearity
v. Robustness
vi. System Suitability
vii. Limit of Quantification/Detection
viii. Range
Remarks: The firm has started initial testing of samples placed on stability
on 04.08.2017 while the validation of testing method performed on
17.07.2017.
27. Do you have method transfer The firm has not conducted method transfer studies. According to the firm
studies in case when the since their analytical method is developed by them hence no method
method of testing being used transfer studies are required.
by your firm is given by any
other lab?
28. Do you have documents The firm showed documents confirming the qualification of equipment /
confirming the qualifications instruments being used in the test and analysis of APIs and the finished
of equipment /instruments drug.
being used in the test and
analysis of APIs and the
finished drug
29. Do your method of analysis The firm‘s method of testing is stability indicating for stability testing of
stability indicating? their finished product, the data sheet submitted by firm verifies the testing
of impurity on samples kept on stability studies. The firm has conducted
impurity testing at one time at 6th month time point it was discussed to
conduct the impurity testing at initial and end time point (i.e., at 0 and 6) to
get an exact verification of impurity profiling/level.
30. Do your HPLC software is Firm has 1 HPLC dedicated for R&D testing at the time of studies
21CFR compliant? conducted (now they have 2) and is 21 CFR II compliant. This HPLC
system is used for stability studies of Velcure Plus Tablet. The HPLC used
for the stability studies is 21-CFR compliant. However, the record from
logbooks, analytical test reports was randomly found verifiable onsite. A
complete trail of such testing was available and verifiable.
31. Can you show Audit Trail A complete trail of such testing was found available and verifiable from log
reports on Velcure Plus books, analytical test reports and software of HPLC as well.
tablets testing?
32. Do you have some The firm has remaining quantities of stability batches as per following
remaining quantities of details:
degradation products and
stability batches?
Samples Remaining
Samples for
Batch Total for Real Packs
S# accelerated
No. Packs Time
studies
studies
T- 22
1 50 12 Packs 16 Packs
035Q
T- 21
036Q
T- 22
037Q
33. Do you have stability The firm has completed the accelerated stability testing on the three
batches kept on stability stability batches of Velcure Plus Tablet. Also the firm has completed the
testing? real time stability testing up to 18 months on all three batches.
34. Do you have valid The firm has valid calibration status for the equipment used in Velcure Plus
calibration status for the Tablet production and analysis as per record available during onsite visit.
equipments used in
production in analysis?
35. Do proper and continuous Continuous power supply and monitoring with back up from generator and
monitoring and control are UPS are available for stability chamber to address the problem of
available for stability
interrupted power supply or load shedding. Portable digital data loggers are
chamber? available for continuous monitoring of temperature and humidity conditions
of stability chamber. The firm submitted date-wise data for every next hour
of temperature and humidity conditions of stability chambers used for
accelerated and real time studies.
36. Do related manufacturing The related manufacturing area, equipment, personnel and utilities are rated

area, equipment, personnel as GMP compliant.
and utilities be rated as GMP
compliant?
Conclusions & Recommendations:

1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Velcure Plus tablets is verifiable to a satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suitable for the
manufacturing of Velcure Plus tablets, therefore, the panel recommends the registration of Velcure Plus
tablets in the name of the manufacturer.
Decision: Registration Board decided to approve registration of ―Velcure Plus Tablets‖ with Innovator‘s
specifications by M/s Global Pharmaceuticals (Pvt) Ltd., Plot # 204-205, Industrial Triangle Kahuta Road,
Islamabad. Manufacturer will place first three production batches on long term stability studies
Sr. Name & Address Brand Name Type of Form, International

No. of Manufacturer / (Proprietary Name + Dosage Initial Diary & Date, Availability / Local
478. M/s. TITLIS Delanso Capsule 30mg Form 5-D DEXILANT 30mg
Pharma 528-A Each capsule contains: Dy. No. 196 Delayed release Capsule
Sundar Industrial Enteric coated pellets of 15-09-2014 USFDA approved
Estate, Lahore Dexlansoprazole …30 mg PKR 50,000/-
(Proton pump inhibitor) 10‘s: As per brand
leader
Delanso Capsule 60mg Form 5-D DEXILANT 60mg
Each capsule contains: Dy. No. 201 Delayed release Capsule
Enteric coated pellets of 15-09-2014 USFDA approved
Dexlansoprazole …60 mg PKR 50,000/-
(Proton pump inhibitor) 10‘s: As per brand
leader
M/s Titlis Pharma had initially submitted stability data for above applied formulations by using pellets from M/s.
Lee Pharma Ltd. India, but in 276th meeting of Registration Board the representative of M/s. Titlis Pharma,
Lahore, appeared and apprised the Board that the pellets used in stability batches do not possess dual delayed
release profile so they will perform and submit new stability studies with different source of pellets. Hence Board
acceded with request of M/s Titlis Pharma and directed to submit new stability data using pellets of dual delayed
release profile as per reference product.
Now recently firm had submitted new stability data by using pellets from M/s Vision Pharmaceuticals,
Islamabad, which was evaluated and proceeded for the onsite inspection.
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Delanso Capsules
30mg & Delanso capsules 60mg by M/s Titlis Pharmaceuticals Lahore.
Inspection Date and Time: 02nd May, 2019
Inspection Site: M/s. Titlis Pharma, 528-A, Sunder Industrial Estate, Lahore.
1. Mr. Shafiq-ur-Rehman (Director DTL, Lahore)
2. Miss Ufaq Tanveer Butt (FID, DRAP, Lahore)
3. Miss Maham Misbah. (Assistant Director, DRAP, Lahore)
Product: DELANSO 30mg & 60mg Capsules

Firm: M/s Titlis Pharmaceuticals Lahore

Q.# QUESTION OBSERVATION BY PANEL
The firm has not imported the API. Rather, the firm has
procured 1 kg Dexlansoprazole DDR pellets locally
Do you have documents confirming the
1. from M/s Vision Pharmaceuticals, Islamabad, having
import API including approval from DRAP?
Batch number DLP240T vide Invoice No.VP0001
dated May 03, 2018.
Previously, firm had conducted stability studies using
pellets from another source (M/s. Lee Pharma India).
During personal hearing, M/s Titlis Pharma had
apprised the Drug Registration Board in its 276 th
meeting that the pellets used in stability batches did not
possess dual delayed release profile. The board had
directed M/s Titlis Pharma to submit new stability data
What was the rationale behind selecting the
2. using pellets of dual delayed release profile as per
particular manufacturer of API?
reference product (Dexilant capsules of M/s Takeda
Pharma).
Selection of the manufacturer is also based upon its
GMP,ISO 9001: 2015, 17025, 14001, PNAC
Certification and already Approved DRAP source.
Eight companies have obtained registration approval
with source Vision Pharmaceuticals Islamabad.
Do you have documents confirming the No reference standard and impurity standards were
3. import of API reference standard and available. But the Firm had procured working standard
impurity standards? of API from Vision Pharmaceuticals Islamabad.
Do you have certificate of Analysis of the
The Firm had certificate of analysis of API and
4. API, reference standards and impurity
Working standard of API.
standards?
Do you have GMP certificate of APIs Yes, The Firm had cGMP Certificate of API‘s
5. manufacturer issued by regulatory authority manufacturer (M/s Vision Pharmaceuticals, Islamabad)
of country of origin? issued by Drug Regulatory Authority of Pakistan.
Do you use APIs manufacturer method of Yes, The Firm is using manufacturer method for testing
6.
testing for testing APIs? of Dexlanoprazole DDR pellets.
Yes, Thefirm has six month accelerated and 36 months
7. Do you have stability studies reports on API?
real time stability studies report of API.
Yes, The stability testing has been performed as per
SIM method and degradation products have been
If yes, whether the stability testing has been
quantified.
8. performed as per SIM method and
Degradation Products are Sulphones & Sulphides.
degradation products have been quantified?
Total Impurity: NMT 2% ( Total Impurity Identified
1.06%)
Do you have method for quantifying the Yes, The Firm had the method for quantifying the
9.
impurities in the API? impurities in the API by normalization method.
Do you have some remaining quantities of the
Yes, The Firm had remaining quantities of API and
10. API, its reference standard and impurities
working standard of API.
standards?
Have you used pharmaceutical grade Not Applicable; Only encapsulation of ready to fill
11.
excipients? pellets is being performed.
Do you have documents confirming the Not Applicable; Only encapsulation of ready to fill
12.
import of the used excipient? pellets has been performed.
Do you have test reports and other records on Not Applicable; Only encapsulation of ready to fill
13.
the excipients used? pellets has been performed.
Do you have written and authorized protocols Yes, The Firm had written and authorized protocols for
14. for the development of Dexlansoprazole DDR the development of DELANSO (Dexlansoprazole)
30mg Capsules? Capsules 30mg and 60mg.
Have you performed Drug-excipients Not Applicable; Only encapsulation of ready to fill
15.
compatibility studies? pellets has been performed.
16. Have you performed comparative dissolution Yes, The Firm had performed comparative dissolution
studies? studies with DEXILANT Capsules 30mg and 60mg
manufactured by M/s Tekeda Pharmaceuticals Limited
(Japan). However, the firm used six vessel dissolution
apparatus (Type II, Model of DS-2013 and Make by
Curio Pakistan).
The firm was advised to purchase twelve vessel
dissolution apparatus for performing comparative
dissolution studies.
The firm was testing Dual Delay Release Profile by
testing the dissolution of the pellets at pH 5.5 and at
pH 7
Yes, The firm had product development (R&D) section
Do you have product development (R&D)
17. for product development,manufacturing& testing
section
facilities for trial batches.
The firm used automatic capsule filling machine of
Do you have necessary equipment available production area (Model: NJP 800) for manufacturing of
in product development section for trial batches. Dedsuster was built in the machine. The
18.
development of Dexlansoprazole DDR 30mg Capsule Polisher (Model HJP-C- Model 150) was
Capsules? available for capsule polishing. Firm was advised to
purchase metal detector.
Are the equipments in product development Yes, All the equipments used in production &testing of
19.
section qualified? Delanso 30mg are qualified.
Do you have proper maintenance / calibration Yes, The firm had proper maintenance & calibration
20. / re-qualification program for the equipment Plan for the equipment used in Product Development.
used in PD section? (Plan Attached)
Do you have qualified staff in product Yes, The firm had qualified staff with suitable
21. development section with proper knowledge knowledge and training in product development.
and training in product development? (Organogram Attached)
The firm have manufactured three stability batches for
the stability studies with following details:
Batch # Mfg date Batch size
Delanso 30mg Capsules
T-050 MAY – 2018 500 Capsules
Have you manufactured three stability T-051 MAY – 2018 500 Capsules
batches for the stability studies of T-052 MAY – 2018 500 Capsules
22.
Dexlansoprazole DDR 30mg capsules as Batch # Mfg date Batch size
required? Delanso 60mg Capsules
The capsules are packed in blisters Alu/Alu foil with
pack size of 2×7‘s.
The criteria for fixing the batch size of stability batches
Do you have any criteria for fixing the batch
23. are based upon the number of Capsules per testing and
size of stability batches?
testing frequencies.
Do you have complete record of production Yes, The firm had complete record of production of
24.
of stability batches? stability batches.
Do you have protocols for stability testing of Yes, The firm had protocols for stability testing of
25.
Do you have developed and validated the The firm had validated method for the testing of
26.
method for testing of stability batches? Delanso 30mg and 60mg Capsules.
Do you have method transfer studies in case
The firm is using manufacturer method of testing, and
27. when the method of testing being used by
has validated the method of testing.
Do you have documents confirming the
Yes, The firm had documents confirming the
qualification of equipments / instruments
28. qualification of equipment / instruments being used in
being used in the test and analysis of API and
the test and analysis of API and the finished drug.
the finished drug?
Does your method of analysis stability Yes, The method of analysis is stability Indicating for
29.
indicating? testing of finished products.
The firm have quaternary gradient HPLC (Shimadzu;
30. Do your HPLC software 21CFR Compliant? Model: LC20AT); with time and date locked but it is
not 21CFR Compliant.
31. Can you show Audit trail reports? Yes, The firm had shown the Audit trail reports.
Yes, The firm had remaining quantities of stability
batches placed in stability chamber for ongoing stability
studies. Remaining Quantities as follows:
Batch # Retaining For ongoing
Samples stability Studies
T-050 84 Capsules 133 Capsules
Do you have some remaining quantities of T-051 70 Capsules 133 Capsules
32.
degradation products and stability batches? T-052 84 Capsules 133 Capsules
Batch # Retaining For ongoing
Samples stability Studies
Yes, The firm had completed the accelerated stability
studies and kept all the three laboratory scale batches of
Delanso 30mg and 60mg capsules for long term
stability studies.
There were two Stability Chambers with following
details:
Do you have stability batches kept on Stability Chamber No 1 ; for Long Run Studies
33.
stability testing? Make: Galvano Scientific
Capacity: 400 Liters
Temperature: 30 +- 2C & 65 % RH
Stability Chamber No 2 ; for Accelerated Studies
Make: Dawn Analytical
Capacity: 400 Liters
Temperature: 40 +- 2C & 75 % RH
Do you have valid calibration status for the Yes, The firm had valid calibration status for the
34. equipments used in Dexlansoprazole DDR equipment used in Delanso 30mg and 60mg Capsules
30mg Capsules production and analysis? production and analysis.
Power backup by UPS & 200kv Generator was
available. Digital data logger was not installed for
Do proper and continuous monitoring and
35. continuous monitoring and control of stability
control are available for stability chamber?
chambers. Storage conditions were being recorded
thrice daily manually.
Yes, The related manufacturing area, equipment,
Do related manufacturing area, equipment,
personnel and utilities are GMP compliant (GMP
36. personnel and utilities be rated as GMP
Certificate No.138/2018–DRAP (AD-709919-530)
compliant?
Valid till 11-07-2019.
Conclusion:-
On the basis of risk-bassed approach, the genuiniess/authenticity of stability data submitted for
registration of Delanso 30mg capsules (Dexlansoprazole 30mg) and Delanso 60mg capsules (Dexlansoprazole
60mg ) is verifiable to satisfactory level and it seems that M/s Titlis Pharma had performed stability studies.
Related manufacturing area, equipment, personnel and utilities are also rated as GMP compliant to satisfactory
level.
Decision: Registration Board decided to approve registration of ―Delanso 30mg capsules
(Dexlansoprazole 30mg) and Delanso 60mg capsules (Dexlansoprazole 60mg )‖ with Innovator‘s
specifications by M/s Titlis Pharma. Manufacturer will place first three production batches of both
products on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.
c. EXEMPTION FROM ONSITE VERIFICATION OF STABILITY DATA:
Sr. Name & Address Brand Name Type of Form, International Remarks
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability / Local
Applicant Dosage Form + Date, Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / GMP Inspection
Pharmacological Pack size Report Date
Group,
Finished Product
Specification
479. M/s Getz Pharma Apixo Tablets 2.5mg Form 5D Eliquis Tablets 2.5mg
Pvt. Ltd Each film coated tablet 30-07-2017 by Bristol-Myers
29-30, Sector 27, contains: DUPLICATE Squibb Pfizer
Korangi Industrial Apixaban...2.5mg DOSSIER (USFDA Approved)
Area, Karachi PKR 50,000/-
Direct Factor Xa 30-06-2017 Last GMP Inspection
Inhibitors As per SRO dated 17-12-2018
(Firm has submitted concluding acceptable
attested copy of fee level of GMP
chalan from ABL compliance status
Karachi along with
undertaking)
Drug Apixo Tablets 2.5mg
Name of Manufacturer M/s Getz Pharma Pvt. Ltd 29-30, Sector 27, Korangi Industrial Area, Karachi
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co. Ltd., China
Description of Pack Alu-Alu Blister
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH Real Time: 30°C ± 2°C/75%±5% RH
Time Period Accelerated: 6 (months) Real Time: 6 (months)
Frequency Accelerated:0,1,3,6 (months) Real Time: 0,3,6 (months)
Batch No. 429DS02 429DS03 429DS04
No. of Batches 03
Date of Submission 1666 (25-03-2019)
1. COA of API. Yes

country of origin or GMP certificate of API Jiangsu Yongan Pharmaceutical Co. Ltd., China issued
manufacturer issued by regulatory authority of by CFDA, China. The certificate is valid till 03-03-
5. Documents confirming import of API etc. Firm has submitted ADC attested invoice confirming
import of 1 Kg Apixaban from M/s Jiangsu Yongan
Pharmaceutical Co. Ltd., China dated 28-12-2017 for
Batch No. 20171127
documents.
1978.
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last two product for Arcox (Etoricoxib) Tablets 90mg & 120mg on
years. 17th September, 2018 and was presented in 286th meeting
of Registration Board held on 14 – 16th November, 2018.
Registration approved the case and the inspection report
confirmed following points
recordavailable with the firm.
 Audit trail on the testing reports is available.
 Adequate monitoring and control are available for
 Stability chamber. Chambers are controlled and
monitoredthrough software having alarm system for
alerts as well.
2. Documents for the procurement of API with Firm has submitted ADC attested invoice confirming
approval from DRAP (in case of import). import of 1 Kg Apixaban from M/s Jiangsu Yongan
Batch No. 20171127
3. Documents for the procurement of reference The firm has submitted that they have procured reference
standard and impurity standards. standards from the API manufacturer in September 2017
through courier. Firm has also submitted copy of invoice.
Documents for procurement of impurity standards is not
submitted.
4. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate of M/s
manufacturer issued by regulatory authority of Jiangsu Yongan Pharmaceutical Co. Ltd., China issued by
country of origin. CFDA, China. The certificate is valid till 03-03-2021.
The certificate has been verified from SFDA website.
5. Mechanism for Vendor pre-qualification Firm has submitted copy of vendor evaluation report of
Apixaban.

6. Certificate of analysis of the API, reference Firm has submitted copy of COA of API and reference
standards and impurity standards standard.
7. Documents for the procurement of excipients The firm has submitted documents for procurement of
used in product development? excipients used in the formulation of applied product.
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in
development with relevant experience. R&D department.
Production Data
9. Authorized Protocols/SOP for the development The firm has submitted copy of product design and
& stability testing of trial batches. development SOP‘s.
10. Complete batch manufacturing record of three The firm has submitted copy of Batch Manufacturing
stability batches. Records of all the three Batches
11. Record of remaining quantities of stability Firm has provided following remaining quantities for each
batches. batch:
429DS02 : 540 Tablets
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted copies of data logger record for
and humidity monitoring of stability chambers stability chambers with real time and accelerated stability
(real time and accelerated) testing
13. Method used for analysis of API along with The firm has submitted copy of Raw Material
COA. Specifications, Raw Material Testing Procedures along
with COA.
14. Method used for analysis of FPP & complete The firm has submitted copy of Finished Product Testing
record of testing of stability batches (i.e. Procedure and specification.
chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted stability study data of 3 batches of
manufacturer. API as per the conditions of Zone IV-A.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used
in applied product development
17. Drug-excipients compatibility studies. The firm has submitted that they have used same
excipients in their formulation as that of reference product
except film coating material. Therefore they have not
performed drug-excipient compatibility studies.
18. Record of comparative dissolution data. The firm has performed comparative dissolution study
with reference product but only at 6.8pH phosphate buffer
with 0.05% SLS while the FDA recommended method is
to test the product in three media including pH 1.2, pH 4.5
and pH 6.8 buffers
19. Compliance Record of HPLC software 21CFR Audit trail on testing reports for the applied product has
& audit trail reports on product testing. been submitted by the firm.
Remarks of the evaluator:
Shortcoming Response by the firm
The firm has performed comparative dissolution Firm has responded that as per assessment report of EMA
study with reference product but only at 6.8pH and USFDA, apixaban belongs to BCS class-III with no
phosphate buffer with 0.05% SLS while the FDA reported concerns pertaining to solubility, and that its
recommended method is to test the product in three solubility is not affected by changes in pH. The firm has
media including pH 1.2, pH 4.5 and pH 6.8 buffers submitted that it is evident that conducting dissolution
study in other pH medium would not have yielded useful
scientific information on release of apixaban. Hence we
have performed dissolution profile study only in QC
release medium.
Decision: Registration Board decided to approve registration of ―Apixo Tablets 2.5mg (Apixaban 2.5mg)
with Innovator‘s specifications by M/s Getz Pharma Pvt. Ltd29-30, Sector 27, Korangi Industrial Area,
Karachi. Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Group,
Finished Product
Specification
480. M/s Getz Pharma Apixo Tablets 5mg Form 5D Eliquis Tablets 5mg
Pvt. Ltd Each film coated tablet 30-07-2017 by Bristol-Myers
29-30, Sector 27, contains: DUPLICATE Squibb Pfizer
Korangi Industrial Apixaban.....5mg DOSSIER (USFDA Approved)
Area, Karachi PKR 50,000/-
Direct Factor Xa 30-06-2017 Last GMP Inspection
Inhibitors As per SRO dated 17-12-2018
(Firm has submitted concluding acceptable
attested copy of fee level of GMP
chalan from ABL compliance status
Karachi along with
undertaking)
Drug Apixo Tablets 5mg
Name of Manufacturer M/s Getz Pharma Pvt. Ltd 29-30, Sector 27, Korangi Industrial Area, Karachi
Description of Pack Alu-Alu Blister
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/75%±5% RH
Time Period Accelerated: 6 (months)
Real Time: 6 (months)
Frequency Accelerated:0,1,3,6 (months)
Real Time: 0,3,6 (months)
Batch No. 428DS02 428DS03 428DS04
No. of Batches 03
1. COA of API. Yes
country of origin or GMP certificate of API Jiangsu Yongan Pharmaceutical Co. Ltd., China issued
manufacturer issued by regulatory authority of by CFDA, China. The certificate is valid till 03-03-
5. Documents confirming import of API etc. Firm has submitted ADC attested invoice confirming
import of 1 Kg Apixaban from M/s Jiangsu Yongan
Batch No. 20171127
documents.
1978.
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product for
inspection for instant dosage form Arcox (Etoricoxib) Tablets 90mg & 120mg on 17th September,
conducted during last two years. 2018 and was presented in 286th meeting of Registration Board
held on 14 – 16th November, 2018. Registration approved the case
and the inspection report confirmed following points
 The HPLC software is 21CFR Compliant as per recordavailable
with the firm.
 Stability chamber. Chambers are controlled and
monitoredthrough software having alarm system for alerts as
well.
2. Documents for the procurement of API Firm has submitted ADC attested invoice confirming import of 1
with approval from DRAP (in case of Kg Apixaban from M/s Jiangsu Yongan Pharmaceutical Co. Ltd.,
import). China dated 28-12-2017 for Batch No. 20171127
3. Documents for the procurement of The firm has submitted that they have procured reference standards
reference standard and impurity from the API manufacturer in September 2017 through courier.
standards. Firm has also submitted copy of invoice.
Documents for procurement of impurity standards is not submitted.
4. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate of M/s Jiangsu
certificate of API manufacturer issued Yongan Pharmaceutical Co. Ltd., China issued by CFDA, China.
by regulatory authority of country of The certificate is valid till 03-03-2021.
origin. The certificate has been verified from SFDA website.
5. Mechanism for Vendor pre- Firm has submitted copy of vendor evaluation report of Apixaban.
qualification
6. Certificate of analysis of the API, Firm has submitted copy of COA of API and reference standard.
reference standards and impurity
standards
7. Documents for the procurement of The firm has submitted documents for procurement of excipients
excipients used in product used in the formulation of applied product.
development?
8. List of qualified staff involved in The firm has submitted List of qualified staff involved in R&D

product development with relevant department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of product design and development
development & stability testing of trial SOP‘s.
batches.
10. Complete batch manufacturing record The firm has submitted copy of Batch Manufacturing Records of
of three stability batches. all the three Batches
11. Record of remaining quantities of Firm has provided following remaining quantities for each batch:
stability batches. 429DS02 : 460 Tablets
QA / QC DATA
12. Record of Digital data logger for Firm has submitted copies of data logger record for stability
temperature and humidity monitoring chambers with real time and accelerated stability testing
of stability chambers (real time and
accelerated)
13. Method used for analysis of API along The firm has submitted copy of Raw Material Specifications, Raw
with COA. Material Testing Procedures along with COA.
14. Method used for analysis of FPP & The firm has submitted copy of Finished Product Testing
complete record of testing of stability Procedure and specification.
batches (i.e. chromatograms, lab
15. Reports of stability studies of API from The firm has submitted stability study data of 3 batches of API as
manufacturer. per the conditions of Zone IV-A.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used in
applied product development
17. Drug-excipients compatibility studies. The firm has submitted that they have used same excipients in their
formulation as that of reference product except film coating
material. Therefore they have not performed drug-excipient
compatibility studies.
18. Record of comparative dissolution data. The firm has performed comparative dissolution study with
reference product but only at 6.8pH phosphate buffer with 0.05%
SLS while the FDA recommended method is to test the product in
three media including pH 1.2, pH 4.5 and pH 6.8 buffers
19. Compliance Record of HPLC software Audit trail on testing reports for the applied product has been
21CFR & audit trail reports on product submitted by the firm.
testing.
The firm has performed comparative dissolution Firm has responded that as per assessment report of
study with reference product but only at 6.8pH EMA and USFDA, apixaban belongs to BCS class-III
phosphate buffer with 0.05% SLS while the FDA with no reported concerns pertaining to solubility, and
recommended method is to test the product in three that its solubility is not affected by changes in pH. The
media including pH 1.2, pH 4.5 and pH 6.8 buffers firm has submitted that it is evident that conducting
dissolution study in other pH medium would not have
yielded useful scientific information on release of
apixaban. Hence we have performed dissolution profile
study only in QC release medium.
Decision: Registration Board decided to approve registration of ―Apixo Tablets 5mg (Apixaban5mg) with
Innovator‘s specifications by M/s Getz Pharma Pvt. Ltd29-30, Sector 27, Korangi Industrial Area, Karachi.
Manufacturer will place first three production batches on long term stability studies throughout proposed

Group,
Finished Product
Specification
481. M/s Crystolite Nutadol 75mg Tablets Form 5D NUCYNTA
Pharmaceuticals. Each film coated tablet Dy No. 3692 TABLETS (USFDA
Plot No. 1&2, contains: Date: 16-04-2019 Approved)
Street No. S-2, Tapentadol (as PKR 50,000/-
National Industrial hydrochloride) …75mg 26-02-2019 GMP Inspection
Zone, Rawat, Analgesic 10 x 10‘s: As per report conducted on
Rawalpindi. (Other opioids) SRO 17th October 2017
Manufacturer‘s concluded that firm is
Specifications. operating at good
level of GMP.
Drug Nutadol 75mg Tablets
Name of Manufacturer M/s Crystolite Pharmaceuticals.
Plot No. 1&2, Street No. S-2, National Industrial Zone, Rawat, Rawalpindi.
Description of Pack 3 x 10‘s Alu-Alu Blister
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (months)
Real Time: 6 (months)
Frequency Accelerated:0,1,2,3,4,6 (months)
Real Time: 0,3,6 (months)
Batch No. 001T18 002T18 003T18
No. of Batches 03
1. COA of API. Yes
country of origin or GMP certificate of API Precise Chemipharma Pvt. Ltd, C-384, T.T.C.
manufacturer issued by regulatory authority of Industrial Area, MIDC Village, Pawane, Navi,
country of origin. Mumbai, India issued by Food and Drug
Administration Mahrashtra state which is valid upto
10-10-2018
5. Documents confirming import of API etc. Firm has submitted ADC attested invoice dated 05-06-
2017 confirming import of 1.2 kg Tapentadol
hydrochloride, Lot No. 6009122016 from M/s Precise
Chemipharma Pvt. Ltd, C-384, T.T.C. Industrial Area,
MIDC Village, Pawane, Navi, Mumbai, India.
documents.
1978.
instant dosage form conducted during last two product TENFAMIDE Tablets 25mg on 17th July, 2018
years. and was presented in 284th meeting of Registration Board.
Registration approved the case and the inspection report
confirmed following points
recordavailable with the firm.
Stability chamber.
2. Documents for the procurement of API with Firm has submitted ADC attested invoice dated 05-06-
approval from DRAP (in case of import). 2017 confirming import of 1.2 kg Tapentadol
hydrochloride, Lot No. 6009122016 from M/s Precise
Chemipharma Pvt. Ltd, C-384, T.T.C. Industrial Area,
MIDC Village, Pawane, Navi, Mumbai, India.
3. Documents for the procurement of reference The firm has submitted undertaking letter from precise
standard and impurity standards. chemipharma that working standard is along with
shipment of sample.
4. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate of M/s
manufacturer issued by regulatory authority of Precise Chemipharma Pvt. Ltd, C-384, T.T.C. Industrial
country of origin. Area, MIDC Village, Pawane, Navi, Mumbai, India issued
by Food and Drug Administration Mahrashtra state which
is valid upto 10-10-2018
5. Mechanism for Vendor pre-qualification Firm has submitted vendor evaluation form filled by
Precise Chemipharma Pvt. Ltd.
6. Certificate of analysis of the API, reference Firm has submitted copy of COA of API and reference
standards and impurity standards standard.
7. Documents for the procurement of excipients The firm has submitted documents for procurement of
used in product development? excipients used in the formulation of applied product.
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in
development with relevant experience. R&D department.
Production Data
9. Authorized Protocols/SOP for the development The firm has submitted copy of product development

& stability testing of trial batches. protocols.
10. Complete batch manufacturing record of three The firm has submitted copy of Batch Manufacturing
stability batches. Records of all the three Batches. The quantity of tablets
finally packed are:
001T18: 483 Tablets
002T18: 488 Tablets
003T18: 483 Tablets
11. Record of remaining quantities of stability Firm has provided following remaining quantities for each
batches. batch:
001T18: 213 Tablets
002T18: 178 Tablets
003T18: 213 Tablets
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted copies of data logger record for
and humidity monitoring of stability chambers stability chambers with real time and accelerated stability
(real time and accelerated) testing
13. Method used for analysis of API along with The firm has submitted copy of Raw Material
with COA.
14. Method used for analysis of FPP & complete The firm has submitted copy of Finished Product Testing
record of testing of stability batches (i.e. Procedure and specification.
chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted stability study data of 3 batches of
manufacturer. API as per the conditions of Zone IV-A.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients used
in applied product development
17. Drug-excipients compatibility studies.
18. Record of comparative dissolution data. The firm has performed comparative dissolution study
with reference product at 4.5 pH and 6.8pH, further the
dissolution test at 10, 20, 30, 45 and 60 min is also
performed.
19. Compliance Record of HPLC software 21CFR Audit trail on testing reports for the applied product has
& audit trail reports on product testing. been submitted by the firm.

Justify the dissolution specification of NLT 80% in Firm has replied that the dissolution specification
60 minutes, since tapentadol is an immediate results of their product Nutadol 75mg tablet at 30
release dosage form and the FDA minutes complies with FDA limits defined in
biopharmaceutics review of the reference product biopharmaceutics review. The firm has stated that
suggests dissolution specification as NLT 80-85% the specification of their commercial product will
in 30 minutes. be NLT 80-85% in 30 minutes.
Decision: Registration Board decided to approve registration of ―Nutadol Tablets 75mg (Tapentadol
75mg)‖ with Innovator‘s specifications by M/s Crystolite PharmaceuticalsRawalpindi. Manufacturer will
place first three production batches on long term stability studies throughout proposed shelf life and on

Evaluator PEC-I
Case No. 01: Registration Applications for Local Manufacturing of (Human) Drugs.
a. New Cases: -
482. Name and address of manufacturer / ARP (Pvt) Ltd Plot 12&12A, Street No W-3, National Industrial
Applicant Zone (RCCI) Rawat Rawalpindi.
Brand Name +Dosage Form + Strength Esitil Tablet 20mg
Escitalopram as Oxalate ………..20mg
Diary No. Date of R& I & fee Dy. No. 7655: 28.02.2018 PKR 20,000/-: 26.02.2018
Pharmacological Group Antidepressant (SSRI) selective Serotonin-reuptake inhibitors.
Type of Form Form 5
Pack size & Demanded Price As approved by the Government/As per SRO
Approval status of product in Lexapro 20 mg tablets by Forest, Inc Subsidiary of Forest
Reference Regulatory Authorities. Laboratories, Inc USA, approved by MHRA of UK
Me-too status Citanew 20mg Tablet by Hilton Pharma Karachi
GMP status Last inspection was conducted on 05&06-10-2017 for the
purpose of renewal of DML and for GMP certificate issuance,
wherein the GMP certificate was issued.
Decision: Approved.
Brand Name +Dosage Form + Strength CO-FLON Capsule 6mg/25mg
Olanzapine …………………………..6mg
Fluoxetine HCL eq to Fluoxetine……25mg
Pharmacological Group Antidepressant, Anti-Psychotic
Type of Form Form 5
Finished Product Specification Firm has claimed manufacturer‘s spec.
Pack size & Demanded Price As per SRO 14‘s Blister Pack
Approval status of product in SYMBYAX capsule by Eli Lilly and Company. (USFDA
Reference Regulatory Authorities. Approved)
Me-too status Olanzo – F 6/25 Capsule by M/s Regal Pharmaceuticals.
Decision: Approved.
484. Name and address of Manufacturer / ARP (Pvt) Ltd Plot 12&12A, Street No W-3, National Industrial
Brand Name +Dosage Form + Strength METAVID Tablet 50mg/1000mg Capsule
Composition Each Film coated Tablet contains:
Vildagliptin…………..50mg
Metformin HCl………1000mg
Pharmacological Group Ant diabetic/ Hypoglycemic
Type of Form Form 5
Pack size & Demanded Price As per SRO 14s,30‘s.
Approval status of product in Galvumet 50mg/ 1000mg film-coated tablet by M/s Novartis
Reference Regulatory Authorities. Pharmaceuticals Australia Pty Limited.
Me-too status Galvus Met 50/1000mg tablet of M/s Novartis (Reg. # 066107)
Decision: Approved.
Brand Name +Dosage Form + Strength Cybix Capsule 30mg
Duloxetine as enteric coated pellets 17.65% equivalent to
Duloxetine.........….. 30mg
Source of pellets: Surge Labs Pvt. Ltd
Pharmacological Group SSNRIs
Type of Form Form 5
Pack size & Demanded Price As per SRO 30‘s
Approval status of product in Cymbalta (Duloxetine 30 mg capsule) by M/s Eli Lilly, USFDA
Me-too status Dulan (Duloxetine 30 mg capsule) by M/s Hilton Pharma.
(Reg#055447)
Duloxetine as enteric coated pellets 17.65% eq. to Duloxetine…..
20mg
Pharmacological Group SSNRIs
Type of Form Form 5
Pack size & Demanded Price As per SRO 14‘s,
Approval status of product in Cymbalta (Duloxetine 20 mg capsule) by M/s Eli Lilly, USFDA.
Me-too status Dulan (Duloxetine 20mg capsule) by M/s Hilton Pharma.
(Reg#055446)
Brand Name +Dosage Form + Strength METAVID Tablet 50mg/850mg Capsule
Vildagliptin……………….50mg
Metformin HCl…………………850mg
Pharmacological Group Anti-Diabetic/ Hypoglycemic
Type of Form Form 5
Pack size & Demanded Price As per SRO 30‘s, 1x14‘s
Approval status of product in GALVUMET 50/850 by Novartis. (TGA Approved)
Me-too status Galvus Met 50mg/850mg Tablet of M/s Novartis (Reg.#066106)
 Decision: Approved with innovator‘s specifications.

Brand Name +Dosage Form + Strength Rexin Tablet 20mg
Composition Each Film coated tablet contains:
Paroxetine as HCL………………20mg
Diary No. Date of R& I & fee Dy No. 7679: 28.02.2018 PKR 20,000/-: 26.02.2018
Pharmacological Group SSRIs
Type of Form Form 5
Pack size & Demanded Price As per SRO 30‘s, 1x7‘s,10‘s,30s
Approval status of product in Paroxetine 20 mg Film-coated tablets. MHRA approved.
Me-too status Frais Tablet 20mg. Reg. No. 82658
Remarks of the Evaluator. The reference product contains paroxetine as HCL hemihydrate,
and firm mentioned, ―Paroxetine HCL‖ accordingly the firm was
asked to correct label claim, adjust the API quantity along with
the submission of required fees.
The firm in response submitted updated form5, revised master
formulation along with fee of Rs. 5000/= with deposit slip No.
0760189 dated 12 March 2019.
Decision: Approved
Brand Name +Dosage Form + Strength Zitpro Tablet 500mg
Azithromycin as Dihydrate……….500mg
Type of Form Form 5
Pack size & Demanded Price As per SRO 1x10‘s, 1x06‘s, 1x12‘s.
Approval status of product in FDA. Zithromax 500mg by M/s Pfizer.
Me-too status Azomax 500mg Tablets by M/s Novartis Reg. No. 45415
Remarks of the Evaluator. The firm was asked to correct label claim, as tablet is film coating
along with submission of required fees.
The firm in response submitted revised updated form5, along
with submission of fee of Rs. 5000/= with deposit slip no.
0760190 dated 12th March 2019.
Brand Name +Dosage Form + Strength Tramacet Tablet 37.5mg/325mg
Composition Each Film Coated Tablet contains:
Tramadol HCL……….37.5mg
Paracetamol…………..325mg
Pharmacological Group Opioid analgesic
Type of Form Form 5
Pack size & Demanded Price As per SRO 1x10‘s, 2x10‘s,
Approval status of product in Tramacet 37.5 mg/ 325 mg film-coated tablets of Grunanthal
Reference Regulatory Authorities. (USFDA)
Me-too status Tonoflex Plus 37.5mg/325mg Reg. No 67163.
Brand Name +Dosage Form + Strength Celmed Capsule 200 mg
Composition Each Capsule contains:
Celecoxib …………………200mg
Type of Form Form 5
Approval status of product in CELEBREX capsule by G.D. Searle (USFDA Approved).
Me-too status Orthocel 200mg Capsule by M/S Lisko Pharmaceuticals,
Karachi.
 Decision: Approved with Innovator‘s Specifications.
Olanzapine ……………………………3mg
Fluoxetine HCL eq. to Fluoxetine……25mg
Pharmacological Group Atypical Anti-Psychotic
Type of Form Form 5
Pack size & Demanded Price As per SRO 14‘s, 30‘s
Approval status of product in Symbyax capsule by Eli Lilly (USFDA Approved).
Me-too status Co-Depricap capsule by Nabiqasim Reg.No. 76136
Decision: Approved.
Olanzapine ……………………………12mg
Fluoxetine HCL eq. to Fluoxetine……25mg
Pharmacological Group Atypical Anti-Psychotic
Type of Form Form 5
Approval status of product in Symbyax capsule by Eli Lilly USFDA Approved.
Me-too status Olanco 12 mg/25mg capsules of M/s Genome (Reg. # 064014).
Brand Name +Dosage Form + Strength Thiorel Capsule 4mg
Thiocolchicoside……………….4mg
Type of Form Form 5
Pack size & Demanded Price As per SRO 2x10‘s,
Approval status of product in Myoplege 4mg approved by ANSM approved.
Me-too status Colril Capsules by Searl Pharma Reg.No. 39261
Brand Name +Dosage Form + Strength Pregabin 100mg Capsule
Pregabalin……………….100 mg
Pharmacological Group Anti-Epileptic
Type of Form Form 5
Pack size & Demanded Price As per SRO 2x7‘s
Approval status of product in Alzain 100 mg Capsules, Hard by Dr. Reddy‘s Laboratories (UK)
Reference Regulatory Authorities. Ltd, approved by MHRA of UK.
Me-too status Zeegab 100mg by Hilton Pharma, Karachi. Reg. No. 47360
Brand Name +Dosage Form + Strength Linvox Tablet 600mg
Linezolid…………………600 mg
Pharmacological Group Antibiotics, Oxazolidinone
Type of Form Form 5
Finished Product Specification Firm had claimed manufacturer‘s specs.
Pack size & Demanded Price As per SRO 1x10‘s, 1x12‘s, 1x14‘s
Approval status of product in Zyvox 600mg Tablet of Pharmacia & Upjohn (USFDA
Reference Regulatory Authorities. approved).
Me-too status Linexa Tablet 600mg by M/s. Cirin Pharma (Reg# 073213)
497. Name and address of Manufacturer / ARP (Pvt) Ltd. Plot 12&12A, Street No W-3, National Industrial
Brand Name +Dosage Form + Strength Fobix Tablet 40mg
Febuxostat ……………….40mg
Pharmacological Group Antigout Agent
Type of Form Form 5
Finished Product Specification Manufacturer‘s spec.

Pack size & Demanded Price As per SRO 2x10‘s.
Approval status of product in Uloric tablets by Takeda (USFDA Approved).
Me-too status Zurig 40mg tablet of M/s Getz Pharma (Reg. # 067290).
Brand Name +Dosage Form + Strength S-MET Tablet 50mg/1000mg
Sitagliptin as Phosphate… ……….50mg
Metformin HCL…………………..1000mg
Pharmacological Group Anti-diabetic/ hypoglycaemic agents.
Type of Form Form 5
Pack size & Demanded Price As per SRO 1x10‘s, 14‘s,
Approval status of product in Janumet Tablets by Merck (TGA approved).
Me-too status Tagipmet XR by M/s Highnoon Labs. (Reg.# 084650).
Remarks of the Evaluator. The firm was asked to correct label claim as firm did not mention
as film coated along with the submission of applicable fee.
The firm in response submitted revised Form-5 with fee of
Rs.5,000/= with deposit slip no. 0760192, dated 12 March 2019.
Brand Name +Dosage Form + Strength Contrazole Capsule 200mg
Fluconazole ……….200mg
Type of Form Form 5
Pack size & Demanded Price As per SRO; 1x4‘s,
Approval status of product in Azocan 200mg Capsules by FDC International Ltd. MHRA
Reference Regulatory Authorities. approved.
Me-too status Fcozole 200mg Capsules by Medicraft Pharmaceuticals (Pvt.)
Ltd. Reg. No. 60237
Brand Name +Dosage Form + Strength S-MET Tablet 50mg/500mg
Sitagliptin as Phosphate ………………50mg
Metformin HCL……………………….500mg
Pharmacological Group Anti-diabetic/ hypoglycemic agents.
Type of Form Form 5
Pack size & Demanded Price As per SRO 1x10‘s, 14‘s,
Approval status of product in Janumet tablets of (TGA approved).
Me-too status Tagipmet XR 50/500 Tablet Reg. No. 84649
Remarks of the Evaluator. The firm was asked to mention film coated in label claim along
with the applicable fee.
The firm in response submitted updated form5 with fee of
Rs.5000/= with deposit slip no. 0760193 dated 11.03.2019.
Brand Name +Dosage Form + Strength Araxone Injection 2gm IV
Ceftriaxone sodium powder eq. to Ceftriaxone……………..2gm
Type of Form Form 5
Pack size & Demanded Price 1x 1‘s As per SRO
Approval status of product in Rocephin IV Injection 2gm By M/s Roche Products Limited
Reference Regulatory Authorities. (MHRA approved)
Me-too status Titan 2gm IV Injection by M/S Macter Pharma (Reg.No. 075825)
Brand Name +Dosage Form + Strength AMSARTAN 5mg/80 mg Tablet
Composition Each Film Coated Tablet contains
Amlodipine besylate eq. to Amlodipine…………5 mg
Valsartan…………. 80 mg
Pharmacological Group Calcium channel blocker/Angiotensin receptor Blocker
Type of Form Form 5
Pack size & Demanded Price As per SRO, 14‘s,28‘s
Approval status of product in Amlodipine / Valsartan 5 mg / 80 mg film-coated tablets by M/s
Reference Regulatory Authorities. Winthrop Pharmaceuticals UK Limited MHRA Approved.
Me-too status Exforge 5/80mg film coated tablets of M/s Novartis (R# 047569).
Brand Name +Dosage Form + Strength AMSARTAN 5mg/160mg Tablet
Amlodipine besylate eq. to Amlodipine ……………5 mg
Valsartan…………. …..160 mg
Type of Form Form 5
Approval status of product in Exforge Tablet By Novartis USFDA Approved.
Me-too status Valam 5/160mg Tablet of CCL Pharma (Reg#050261)
th
See for dedicated section
Brand Name +Dosage Form + Strength METAVID 50mg/500mg Tablet
Vildagliptin ………..50 mg
Metformin HCl…….500 mg
Pharmacological Group Hypoglycemic agent
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer‘s specifications.
Pack size & Demanded Price As per SRO, 30‘s
Approval status of product in GALVUS MET 50mg/500mg tablets. Swiss-Medics approved.
Me-too status Galmet 50mg/500mg Table M/s Vision Pharmaceuticals,
Remarks of the Evaluator The firm was asked to mention film coated in label claim along
with the applicable fee.
Rs.5000/= with deposit slip no. 0760194 dated 11.03.2019.
Brand Name +Dosage Form + Strength RESPOCURE 250mg Dry Suspension
Composition Each 5 ml contains Clarithromycin taste masked granules 27.5 %
eq. to Clarithromycin…………..250mg
Source of granules: Surge Labs Pvt. Ltd
Type of Form Form 5
Pack size & Demanded Price As per SRO, 1x 6ml in 90ml Glass Bottle
Approval status of product in USFDA Approved
Me-too status Claritek Tablets of M/s Getz Reg. No 61347
Remarks of the Evaluator The firm applied for Respocure 250/5ml, but mentioned as
Respocure 125/5ml dry suspension. The firm was asked to
clarify.
Rs.5000/= with deposit slip no. 0760195 dated 12 March 2019.
Brand Name +Dosage Form + Strength AMSARTAN 10mg/160mg Tablet
Amlodipine besylate eq. to
Amlodipine………………….. 10mg
Valsartan……………………..160 mg
Type of Form Form 5
Approval status of product in Exforge Tablet By Novartis USFDA Approved
Me-too status Exforge 10/160mg Film Coated Tablets. Reg. No 47571
Composition Each Capsule contains
Duloxetine Enteric coated pellets 17.65% eq. to
Duloxetine………..60 mg
Pharmacological Group Selective Serotonin and Norepinephrine reuptake inhibitors
SSNRI‘s
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer‘s specifications
Approval status of product in Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly, USFDA
Me-too status Duprex Capsule 60mg CCL Pharmaceuticals, Reg. No. 54412
Brand Name +Dosage Form + Strength LOXEN 4mg Tablet
Lornoxicam ………..4 mg
Pharmacological Group Non-steroidal anti-inflammatory drug (NSAID)
Type of Form Form 5
Approval status of product in Xefo 4 mg tablet (EMA approved)
Me-too status Acabel 4mg Tablet by M/s Continental Pharma (Reg.
No:061603)
Brand Name +Dosage Form + Strength LOXEN 8mg Tablet
Lornoxicam ………..8 mg
Pharmacological Group Non-steroidal anti-inflammatory drug (NSAID)
Type of Form Form 5
Approval status of product in Xefo 8 mg tablet (EMA approved).
Me-too status LoxiBar 8mg Tablet Of M/S Barret Hodgson Reg. No. 81193.
 Decision:Approved with manufacturer‘s specifications.
Brand Name +Dosage Form + Strength Celmed Capsule 100mg
Celecoxib………..100 mg
Pharmacological Group NSAIDs
Type of Form Form 5
Approval status of product in Celebrex 100 mg capsules, hard by Pfizer Limited. MHRA
Reference Regulatory Authorities. approved
Me-too status Bexicox 100 Capsule by Medipak Ltd, Lahore. Reg. No. 23946
 Decision:Approved with innovator‘s specification.
Brand Name +Dosage Form + Strength LINVOX 400mg Tablet
Linezolid……………………400 mg
Pharmacological Group synthetic antibacterial agent
Type of Form Form 5
Pack size & Demanded Price As per SRO, 1x 10‘s &1x 12‘s.
Approval status of product in USFDA Approved.
Me-too status Ecasil Tablet of M/s Sami Pharmaceuticals (Reg. # 067162).
Brand Name +Dosage Form + Strength ISOFLOX 750mg Tablet
Levofloxacin hemihydrate USP
Eq. Levofloxacin…………….750mg
Pharmacological Group Flouroquinolones antibiotic
Type of Form Form 5
Pack size & Demanded Price As per SRO, 1x 10‘s
Approval status of product in USFDA approved
Me-too status Oliza 750 Tablets by M/s UniMark Pharma (Reg.#038004)
 Decision: Approved with manufacturer‘s specifications.

Brand Name +Dosage Form + Strength FOBIX 80mg Tablet
Febuxostat……………….80 mg
Pharmacological Group Antigout Agent
Type of Form Form 5
Pack size & Demanded Price As per SRO, 2x 10‘s
Approval status of product in Uloric tablets by Takeda (USFDA Approved).
Me-too status Zurig 80mg Tablet of M/s Getz Pharma Pvt Ltd.
Remarks of the Evaluator The firm mentioned Fobix 80mg on deposit slip but mentioned
Uricstat 80mg on Form5, Firm was asked to clarify.
The firm was also asked to correct label claim, as firm mentioned
uncoated in label claim and submitted formulation for film
coating.
Rs.5000/= with deposit slip No. 0760196 dated 12 March 2019.
But submitted deposit slip was mistakenly written as Fobix 40mg
and febuxostat 40mg, Firm also submitted undertaking for
mistake.
 Decision: Approved with innovator‘s specification.
Brand Name +Dosage Form + Strength TORYX 60mg Tablet
Etoricoxib …………………60 mg
Pharmacological Group Non-steroidal anti-inflammatory drug (NSAID) selective COX-2
inhibitors.
Type of Form Form 5
Approval status of product in ARCOXIA 60mg Film-Coated Tablets (MHRA approved).
Me-too status Etoria 60mg table of M/s Hygeia Pharma, Islamabad (Reg#080818)
515. Name and address of manufacturer / M/s. Axis Pharmaceuticals 3-B, Value addition City, 1.5Km
Applicant Khurrianwala – Sahianwala road Faisalabad.
Brand Name +Dosage Form + Strength Nimsulin Tablets
Composition Each Film Coated Tablet contains;
Nimesulide…….……... 100mg
Pharmacological Group Non-steroidal anti-inflammatory drug (NSAID) selective COX-2
inhibitors.
Type of Form Form-5
Approval status of product in Approved by EMA.
Me-too status Nims Table 100mg by M/S Sami Pharmaceuticals Reg.No. 26657

GMP status Last inspection was conducted on 19th Sep & 3rd October 2018 by
panel for the purpose of grant of GMP certificate, panel rated the
firm operating at fair level of compliance with GMP and
recommended for grant of GMP.
 Decision: Deferred for evidence of approval of applied formulation as ―film coated tablet‖ by
reference regulatory authorities adopted by Registration Board in its 275 th meeting.
Brand Name +Dosage Form + Strength Velamet Tablets 50/850 mg
Vildagliptin…………………………………50mg
Metformin Hydrochloride ……….…………850mg
Pharmacological Group Hypoglycaemic
Type of Form Form 5
Finished Product Specification Firm has claimed manufacturer‘s specifications.
Approval status of product in Galvumet Tablet Of (TGA Approved).
Me-too status Galvusmet 50mg/850mg Tablet of M/s Novartis Pharma Stein
AG, Switzerland. (Reg#066106).
 Decision:Approved with Innovator‘s specifications with a shelf life of 18 months.
Brand Name +Dosage Form + Strength Velamet tablets 50/1000 mg
Vildagliptin……………………………..…50mg.
Metformin Hydrochloride ……….……….1000mg
Pharmacological Group Hypoglycemic
Type of Form Form 5
Approval status of product in Galvumet Tablet Of (TGA Approved).
Me-too status Vilget-M 50mg+1000mg Tablet M/s Getz
 Decision:Approved with Innovator‘s specifications with a shelf life of 18 months.
Brand Name +Dosage Form + Strength Stelomin Tablets
Sitagliptin as Phosphate…………50mg
Metformin hydrochloride………..500mg
Diary No. Date of R& I & fee Dy. No. 9984 Dated: 16-03-18 Rs.20,000/- Dated: 09-03-18
Pharmacological Group Hypoglycemic
Type of Form Form-5
Me-too status Tagipmet XR by M/s Highnoon Labs. (Reg.# 084649).
Brand Name +Dosage Form + Strength Stelomin Plus Tablets
Sitagliptin as phosphate………………………50mg
Metformin Hydrochloride (USP)……………1000mg
Pharmacological Group Hypoglycaemic
Type of Form Form 5
Approval status of product in Approved by USFDA.
Me-too status Tagipmet XR by M/s Highnoon Labs. (Reg. # 084650).
520. Name and address of manufacturer / SPL Pharmaceuticals, Plot #4, Phase III, Hattar Industrial Estate
Applicant Hattar-Pakistan.
Brand Name +Dosage Form + Strength Owell 40mg Capsule
Composition Each Delayed Release Capsule Contains:-
Omeprazole as enteric coated pellets 8.5%.................40mg
Source of pellets: M/s Vision Pharmaceuticals.
Diary No. Date of R& I & fee Dy. No. 11354: 28.03.2018 PKR 20,000/:- 27.03.2018
Pharmacological Group Proton Pump inhibitors
Type of Form Form 5
Approval status of product in Losec 40 mg hard gastro-resistant capsules by AstraZeneca UK
Reference Regulatory Authorities. Ltd. Approved by MHRA.
Me-too status Xempra 40mg Capsule by Nimrall Laboratories Reg. No. 60029.
GMP status Panel inspection was conducted on 04.01.2018 for the purpose of
renewal of DML and panel unanimously recommended the
renewal of DML.
Brand Name +Dosage Form + Strength Rocetec injection 500mg
Composition Each vial contains:-
Ceftriaxone sodium powder eq. to Ceftriaxone…..500mg
Diary No. Date of R& I & fee Dy. No. 11351:- 28.03.2018 PKR 20,000/:- (27.03.2018)
Type of Form Form 5
Pack size & Demanded Price 1‘s As per SRO
Islamabad. (Reg. #031982).

Brand Name +Dosage Form + Strength Mepraz 20mg capsule
Composition Each Delayed Release Capsule Contains:
Esomeprazole (as magnesium Trihydrate) enteric coated pellets
……….......20mg
Source of pellets: M/s Vision Pharmaceuticals.
Pharmacological Group Proton Pump inhibitors
Type of Form Form 5
Approval status of product in Esomeprazole magnesium Capsule 20mg of Mylan
Reference Regulatory Authorities. Pharmaceuticals USFDA.
Me-too status Esomax Capsule 20mg of M/s Martin Dow Pharmaceuticals.
Brand Name +Dosage Form + Strength Q-Mox 400mg Tablets
Moxifloxacin as HCL……………….400mg
Pharmacological Group Fluoroquinolones.
Type of Form Form-5
Finished Product Specification Manufacturer specification.
Pack size & Demanded Price 1 x 5‘s: As per SRO
Approval status of product in AVELOX Tablets of USFDA approved.
Me-too status Swismox 400mg Tablet of M/s Swiss, Karachi (Reg.#070659)
Remarks of the Evaluator The firm applied for Qmox 400mg tablet while attached deposit
slip is for Qmox capsule. Firm was asked for clarification.
The firm in response submitted undertaking that by mistake
capsule was written on deposit slip, and requested to consider and
present it before Registration Board.
Decision: Deferred for seeking opinion of Legal Affair Division.
524. Name and address of manufacturer / Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area,
Applicant Islamabad.
Brand Name +Dosage Form + Strength Dobro 100mgTablets
Spironolactone………………….100mg
Diary No. Date of R& I & fee Dy No. 9979: 16.03.2018 PKR 20,000/:- 14.03.2018
Pharmacological Group Potassium Spring Diuretic
Type of Form Form 5
Approval status of product in Aldactone of (USFDA approved).
Me-too status Spirone 100 mg Tablets M/s Caraway Pharmaceuticals.

GMP status GMP inspection was conducted on 14.09.2017 &21.09.2017 and
concluded as firm found to be operating at very good level of
GMP.
Brand Name +Dosage Form + Strength Dobro Plus Tablets
Spironolactone……………….50mg
Furosemide…………………..20mg
Type of Form Form 5
Pack size & Demanded Price 2 x 10‘s, As per SRO
Approval status of product in Osyrol Lasix of Sanofi Aventis, GmbH, Germany.
Me-too status Spiromide Tab 20mg/50mg of Searle company.
GMP.
Brand Name +Dosage Form + Strength Dobro 25mg Tablets
Spironolactone…………25mg
Type of Form Form 5
Pack size & Demanded Price 100‘s: As per SRO.
Approval status of product in Aldactone of (USFDA approved)
Me-too status Acclazide Tablets 25mg Tablets M/s Consolidated Chemicals
Reg. No. 23843
GMP.
 Decision: Approved with BP Specefications.
527. Name and address of manufacturer / Welmark Pharmaceuticals Plot. No. 122, Block B, Phase V,
Applicant Industrial Estate Hattar KPK.
Brand Name +Dosage Form + Strength Recowel 50mg/5ml Injection
Rocuronium Bromide…………50mg
Pharmacological Group Non-depolarizing neuromuscular blocker
Type of Form Form5
Me-too status Esmeron Injection 50mg of M/s Organon Pakistan Pvt.
(Reg.#021154)
GMP status GMP inspection was conducted on 16.19.2017 and concluded as
overall the firm was GMP compliant as per DRAP guidelines.
 Decision: Deferred for confirmation of vial manufacturing facility.
Brand Name +Dosage Form + Strength Amlodipril 8mg/5mg
Perindopril Erbumine……..8mg
Amlodipine Besylate eq. to Amlodipine…….5mg
Pharmacological Group Anti-Hypertensive
Type of Form Form-5
Approval status of product in Perindopril ter-butylamine/ Amlodipine CF 8/5mg un-coated
Reference Regulatory Authorities. tablets (Approved in Netherland)
Me-too status Coversam 8/5mg tablet of M/s Servier Research &
Pharmaceuticals (Reg.# 065961)
 Decision: Approved with Innovator‘s specifications.
Brand Name +Dosage Form + Strength Orlimark 120mg capsules
Composition Each Capsule Contains:-
Orlistat…………………120mg
Source:- M/s Vision Pharmaceuticals.
Pharmacological Group Anti-Obesity Agents
Type of Form Form-5
Approval status of product in Beacita Capsule by Actavis
Me-too status Orlifit Capsule by Getz Pharma Reg. No. 42390
 Decision: Deferred for further deliberation regarding stability of Orlistat Pellets.
Brand Name +Dosage Form + Strength Amlodipril 4mg/5mg
Perindopril Erbumine………………………..4mg
Amlodipine Besylate eq. to Amlodipine…….5mg
Pharmacological Group Anti-Hypertensive
Type of Form Form-5

Approval status of product in Perindopril ter-butylamine/ Amlodipine CF 4/5mg un-coated
Reference Regulatory Authorities. tablets (Approved in Netherland).
Me-too status Coversam 4/5mg tablet of M/s Servier Research &
Pharmaceuticals, Pakistan (Reg. # 065962).
Brand Name +Dosage Form + Strength Recowel 100mg/10ml
Composition Each Vial Contains:-
Rocuronium Bromide…………100mg
Pharmacological Group Non-depolarizing neuromuscular blocker
Type of Form Form5
Approval status of product in Esmeron Injection By M/S NV Organon, Approved by MHRA.
Me-too status Esmeron Injection 50mg of M/s Organon Pakistan (Pvt)
(Reg.#021155)
 Decision: Deferred for confirmation of vial manufacturing facility.
Brand Name +Dosage Form + Strength Welgard 80mg Tablet
Composition Each Tablet Contains:-
Nadolol ………………..80mg
Pharmacological Group Non-Selective Beta Blocker
Type of Form Form-5
Approval status of product in Corgard 80mg tablet by Sanofi Aventis(MHRA Approved).
Me-too status NALID 80mg Tablets By M/S Genome Pharmaceuticals Hattar.
Brand Name +Dosage Form + Strength Markcon 100mg
Itraconazole …………………100mg
Pharmacological Group Anti-Fungal
Type of Form Form-5
Pack size & Demanded Price As per SRO,
Approval status of product in Itraconazole 100 mg capsules, hard by M/s SandozLimited
Reference Regulatory Authorities. (MHRA Approved).

Me-too status Rolac 100mg Capsules of Sami Pharmaceuticals, Reg.No. 24491.
Remarks of the Evaluator The firm was asked to correct label claim as reference product
contains Itraconazole 100 mg and mentioned as Itraconazole
10mg on Form-5 along with the submission of applicable fee.
The firm in response submitted that it is typing mistake, whereas
in rest of pages it is 100mg and submitted the revised form 5
without submitting applicable fee.
 Decision: Deferred for submission of applicable fee.
Brand Name +Dosage Form + Strength Irofer 500mg/10ml
Composition Each ampoule of 10ml Contains:-
Iron as ferric carboxymaltose ……….500mg
Pharmacological Group Hematinic
Type of Form Form-5
Pack size & Demanded Price 10 ml ampoule,As per SRO
Approval status of product in Ferinject 50mg/ml (ANSM, France)
Me-too status Ferinject 50mg/ml of RG Pharma Reg. No 72548
Remarks of the Evaluator The Firm has claimed reference product which contains 500mg
and mentioned on deposit slip is 50mg. Accordingly the firm was
asked to submit clarification.
The firm in response submitted that by human error they
mentioned 50mg instead of 50mg/ml in deposit slip without
submission of undertaking.
 Decision: Deferred for submission of applicable fee.
Brand Name +Dosage Form + Strength De-Cholic 500mg Capsule
Ursodeoxycholic acid………………..500mg
Pharmacological Group Bile acid
Type of Form Form-5
Pack size & Demanded Price 10‘s, As per SRO
Approval status of product in Ursochol 500 mg capsule, hard By Orifarm Generics A/S
Reference Regulatory Authorities. (Sweden Approved).
Me-too status Rivsa 500mg Capsule by M/S Martin Dow Ltd Reg. No 82264.
 Decision: Approved with BP Specifications.
Brand Name +Dosage Form + Strength De-Cholic 250mg Capsule
Ursodeoxycholic acid………………250mg
Pharmacological Group Bile acid
Type of Form Form-5
Pack size & Demanded Price 10‘s, As per SRO
Approval status of product in Ursodeoxycholic acid 250mg Hard Capsules by M/s Strides
Reference Regulatory Authorities. Pharma UK Ltd MHRA approved.
Me-too status Rivsa 250mg Capsule by M/S Martin Dow Ltd Reg. No 82265.
537. Name and address of manufacturer / Innvotek Pharmaceuticals Plot 35 Industrial Triangle Kahuta
Applicant Road Islamabad.
Brand Name +Dosage Form + Strength Aceril 1.25 mg Tablet
Ramipril ………………1.25 mg
Pharmacological Group ACE inhibitor
Type of Form Form 5
Pack size & Demanded Price 14‘s, 10‘s, 20‘s, 28‘s,30‘s ,50‘s As per SRO
Approval status of product in Tritace 1.25 mg tablets By Sanofi Aventis Pharma Ltd. UK.
Me-too status Ramipace 1.25 mg Tablet by M/S Pharmevo Ltd. Reg. No. 29172
GMP status GMP inspection conducted on 9-11-2017 concluded that firm is
working at satisfactory level of GMP compliance.
Remarks of the Evaluator Firm has submitted the GMP certificate issued to the firm based
on inspection conducted on 30.11.2017.
The firm has submitted grant of approval sections/amendments
Approval decision for Tablet and Capsule section.
Decision: Approved with BP Specifications.
Brand Name +Dosage Form + Strength Aceril 2.5 mg Tablet
Ramipril …………………….2.5 mg
Type of Form Form 5
Approval status of product in Tritace 2.5 mg tablets By Sanofi Aventis Pharma Ltd. UK.
Me-too status Ramipace 2.5 mg Tablet by M/S Pharmevo Ltd. Reg. No. 29173.
Brand Name +Dosage Form + Strength Aceril 5 mg Tablet
Ramipril ………………….5 mg

Type of Form Form 5
Approval status of product in Tritace 5 mg tablets By Sanofi Aventis Pharma Ltd. UK(MHRA
Reference Regulatory Authorities. Approved).
Me-too status Ramipace 5 mg Tablet by M/S Pharmevo Ltd. Reg. No. 29173
Brand Name +Dosage Form + Strength Aceril 10 mg Tablet
Ramipril ……………………..10 mg
Type of Form Form 5
Approval status of product in Tritace 10 mg tablets By Sanofi Aventis Pharma Ltd. UK.
Me-too status Ramipace 10 mg Tablet by M/S Pharmevo Ltd. Reg. No. 34428
Brand Name +Dosage Form + Strength Folex Tablet
Composition Each Chewable tablet contains:-
Iron III hydroxide Polymaltose complex eq. to elemental iron-----
------------------------100mg
Folic Acid--------- 0.35mg
Type of Form Form-5
Pack size & Demanded Price 10‘s , 30‘s
Approval status of product in Ferrum Fol 100mg/ 350mg chewable Tablets, HPRA Ireland
Reference Regulatory Authorities. Approved.
Me-too status Polymalt F Chewable Tablet by High Q Pharmaceuticals Reg.
No. 73606

Remarks of the Evaluator Firm applied for chewable tablet and submitted formulation for
film coating, accordingly firm was asked to submit clarification.
Firm in response submitted revised formulation and submitted fee
of Rs.5000/= with deposit No. 0814265 dated 14th March 2019.
Firm has submitted the GMP certificate issued to the firm based
Decision: Registration Board approved the case with innovator‘s specification, since iron
Brand Name +Dosage Form + Strength Clotek50 mg Tablet
Clomiphene Citrate ………………50mg
Pharmacological Group Selective Estrogen receptor Modulator, Ovulator Stimulant
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s , 50‘s
Approval status of product in Clomid 50 mg Tablet by Aventis Pharma Limited. (MHRA
Me-too status Ovafin 50 mg Tablet by M/s OBS (Reg#019173).
The panel has inspected the M/s Innvotek Pharmaceuticals as per
following mandate:
i- Recommendations for grant of Renewal of DML no.000487.
ii- Amendment/changes in existing sections:
Tablet section Gen (revised) and Capsule Section (revised)
inspection and recommendations.
Keeping in view of the above facts on record, the panel
unanimously recommends the renewal of DML no.000487 by
way of formulation and recommends the amendment changes in
existing sections: Tablet section Gen (Revised) and Capsule
section (revised) to M/s Invotek Pharma Islamabad.
Remarks of the Evaluator As the Product contains Clomiphene citrate and firm mentioned
―Clomiphene as citrate‖ Accordingly firm was asked to submit
revised form 5 with submission of applicable fee. If any.
The firm in response submitted form 5 with correct label claim
and deposit slip of Rs.5000/= with deposit No. 0814266 dated
14th March 2019.
The Firm has submitted the GMP certificate issued to the firm
based on inspection conducted on 30.11.2017.
Decision: Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and personnel
which remain in direct contact or are involved in close handling of these drugs.
Brand Name +Dosage Form + Strength Candetar 8 mg Tablet
Candesartan Cilexetil ………………8mg
Pharmacological Group Angiotensin II Receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 7‘s, 14‘s, 28‘s, 30‘s , 56‘s ,70‘s as per SRO
Approval status of product in Amias Tablet 8 mg by M/S Takeda UK Limited (MHRA
Me-too status Advant 8 mg Tablet by Getz Pharma Pakistan Reg. No 36059
Brand Name +Dosage Form + Strength Candetar 16 mg Tablet
Candesartan Cilexetil ………………16mg
Type of Form Form 5
Pack size & Demanded Price 7‘s, 14‘s, 28‘s, 30‘s , 56‘s ,70‘s as per SRO
Approval status of product in Amias Tablet 8 mg by M/S Takeda UK Limited MHRA
Me-too status Advant 16 mg Tablet by Getz Pharma Pakistan Reg. No 34070
Brand Name +Dosage Form + Strength Candezide 16/12.5 Tablet
Candesartan Cilexetil………………..16mg
Hydrochlorothiazide …………………12.5 mg
Thiazide Diuretic
Type of Form Form 5
Pack size & Demanded Price 7‘s, 14‘s, 28‘s, 20‘s As per SRO
Approval status of product in Candesartan and Hydrochlorothiazide 16/12.5 by MYLAN
Reference Regulatory Authorities. PHARMS INC, US FDA Approved.
Me-too status Advantec 16/12.5 Tablet by Getz Pharma Pakistan Reg.No 39428
The firm applied for uncoated tablet while submitted finish
product specification for coated tablet, Firm was asked to clarify.
The firm in response submitted revised formulation for uncoated
tablet without submission of fee.


546. Name and address of manufacturer / Wenovo Pharmaceuticals Plot 31 & 32 Punjab Small Industrial
Applicant Estate Taxila Rawalpindi.
Brand Name +Dosage Form + Strength Topiwen 25mg Tablet
Composition Each Film-Coated Tablet Contains:-
Topiramate……………….25mg
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per SRO
Approval status of product in Topamax 25 mg film-coated tablets by M/s Janssen-Cilag
Reference Regulatory Authorities. Limited (MHRA Approved).
Me-too status Neutop 25mg Tablet by M/s Nabiqasim (Reg#076387)
GMP status GMP inspection conducted on 30-09-2018 & 29-10-2018.
Firm is compliant to current Good Manufacturing requirements
with need of some improvements which have been discussed and
agreed with the management; panel unanimously recommends
the grant of GMP certificate.
Brand Name +Dosage Form + Strength Topiwen 100mg Tablet
Topiramate…100mg
Type of Form Form-5
Approval status of product in Topamax (MHRA approved)
Me-too status Engrax Tablets 100mg of M/s English Pharmaceuticals
Industries. (Reg# 040144).
Brand Name +Dosage Form + Strength Wendine 5 mg Tablet
Ivabradine as HCl ……...5mg
Diary No. Date of R& I & fee Dy. No. 10703: 22-03-2018 PKR 20,000/-: 21-03-2018
Pharmacological Group Antianginal
Type of Form Form-5
Finished Product Specification Manufacturers Specification
Approval status of product in Corlanor 5mg (US FDA approved).
Me-too status Sivab Tablet 5 mg of M/s Getz Pharma (Pvt.) Ltd Reg. No. 76442
Brand Name +Dosage Form + Strength Wendine 7.5 mg Tablet
Ivabradine as HCl ……...7.5mg
Pharmacological Group Antianginal
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per SRO.
Approval status of product in Corlanor 7.5mg (US FDA approved)
Me-too status Sivab Tablet 7.5 mg of M/s Getz Pharma Reg. No. 076443
Brand Name +Dosage Form + Strength Rispowen 1 mg Tablet
Risperidone……………..1mg
Diary No. Date of R& I & fee Dy. No. 10681: 22-03-2018 PKR. 20,000/-: 21-03-2018
Pharmacological Group Anti-Psychotic
Type of Form Form-5
Me-too status Risperin Tablets 2mg of M/S Hansel Pharma (Reg. # 41346).
Risperidone…………….2mg
Diary No. Date of R& I & fee Dy No. 10681: 22-03-2018 PKR. 20,000/-: 21-03-2018
Type of Form Form-5
Me-too status Risperin Tablets 2mg of M/S Hansel Pharma (Reg. # 41347).
Risperidone ………………..3mg
Type of Form Form-5
Me-too status Risperin Tablets 2mg of M/S Hansel Pharma (Reg. # 41347)
Risperidone…….………4mg
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per SOP
Me-too status Apprid Tablets 4mg of M/S Usawa Pharmaceuticals, Risalpur
(Reg.# 43322)
Brand Name +Dosage Form + Strength Flozapine 3/25 mg capsule
Composition Each Capsule contains:-
Olanzapine……………..............3 mg
Fluoxetine as hydrochloride...…25 mg
Pharmacological Group SSRI/Thienbenzodiazepine.
Type of Form Form-5
Finished Product Specification USP Specifications
Approval status of product in Symbyax 3 mg/25 mg Capsules of Eli Lilly, USA (USFDA).
Me-too status Olanco Capsules by Genome Pharma. (Reg. # 079388).
Brand Name +Dosage Form + Strength Wenvax 37.5 mg Tablet
Venlafaxine Hydrochloride Eq. to Venlafaxine…37.5mg
Pharmacological Group Selective serotonin and norepinephrine reuptake inhibitor (SNRI)
Type of Form Form-5
Approval status of product in Venlafaxine Hydrochloride 37.5mg tablets by M/s Teva
Reference Regulatory Authorities. Pharmaceuticals USA (USFDA Approved)
Me-too status Amfax 37.5mg Tablets by M/s Amson (Reg#029062)

Remarks of the Evaluator The firm was asked to clarify that they applied for film coated
tablet, and submitted formulation as extended release, whereas
approved formulation in reference countries is extended release
and uncoated.
The firm in response submitted the revised formulation for
uncoated tablet along with fee of Rs.5000/ with deposit slip no.
1917516 dated 19.03.2019.
Brand Name +Dosage Form + Strength Wenvax 50 mg Tablet
Venlafaxine Hydrochloride Eq. to Venlafaxine……..50mg
Pharmacological Group Selective serotonin and norepinephrine reuptake inhibitor (SNRI)
Type of Form Form-5
Approval status of product in Venlafaxine Hydrochloride 50mg extended release tablets by M/s
Reference Regulatory Authorities. OSMOTICA PHARM USA (USFDA Approved).
Me-too status Amfax 50mg Tablets by M/s Amson (Reg#029070)
Remarks of the Evaluator The firm was asked to clarify that they applied for film coated
tablet, and submitted formulation as extended release, whereas
approved formulation in reference countries is extended release
and uncoated.
The firm in response submitted the revised formulation for
uncoated tablet along with fee of Rs.5000/ with deposit slip no.
1917515 dated 19.03.2019.
Brand Name +Dosage Form + Strength Valpine 5/80 mg tablet
Amlodipine as Besylate …….…5mg
Valsartan………………………..80mg
Pharmacological Group Anti-Hypertensive, Calcium Channel Blocker
Type of Form Form-5
Finished Product Specification USP specification
Approval status of product in Amlodipine Besylate and Valsartan 5/80 mg of Par Pharm
Reference Regulatory Authorities. (USFDA).
Me-too status Avcard 5/80mg Tablets by Hilton Pharma (Reg. No. 55137)
Brand Name +Dosage Form + Strength Valpine 5/160mg Tablet
Amlodipine as besylate……5mg
Valsartan…………………...160mg
Pharmacological Group Anti-Hypertensive, Calcium Channel Blocker

Type of Form Form-5
Approval status of product in Exforge 5 mg/160 mg Film-coated tablets by M/S Novartis
Reference Regulatory Authorities. (EMA Approved).
Me-too status Avcard 5/160 mg Tablets by Hilton Pharma (Reg. No. 55138)
Brand Name +Dosage Form + Strength Valpine 10/160mg tablet
Composition Each Film Coated Tablet Contains:-
Amlodipine Besylate as Amlodipine…10mg
Valsartan………………………………160mg
Pharmacological Group Anti-Hypertensive, Calcium Channel Blocker.
Type of Form Form-5
Finished Product Specification USP specification
Approval status of product in Exforge 10 mg/160 mg film-coated tablets by Novartis (EMA
Me-too status Avcard 10/160 mg Tablets by Hilton Pharma (Reg. No. 55139)
Brand Name +Dosage Form + Strength Vilmet 50/500mg Tablets
Vildagliptin……………………50mg
Metformin hydrochloride……..500mg
Pharmacological Group Ant diabetic
Type of Form Form-5
Finished Product Specification Firm has claimed manufacturer‘s specification.
Approval status of product in GALVUMET 50/500 film coated tablet by
Reference Regulatory Authorities. NovartisPharmaceuticals (TGA Australia Approved).
Me-too status Galmet 50mg/500mg Tablet by M/S Vision (Reg. No.81905)
Brand Name +Dosage Form + Strength VILMET 50/850mg Tablets
Vildagliptin ……………………...50mg
Metformin Hydrochloride……….850mg
Type of Form Form-5
Approval status of product in Galvumet Tablet Of (TGA Approved)
Brand Name +Dosage Form + Strength VILMET 50/1000mg Tablets
Vildagliptin…………………50mg
Metformin Hydrochloride…1000mg
Type of Form Form-5
Approval status of product in GALVUMET 50/1000 film coated tablet by
Reference Regulatory Authorities. NovartisPharmaceuticals (TGA Australia Approved).
Decision: Approved with Innovators specifications.
Brand Name +Dosage Form + Strength LINZ 400 mg Tablet
Linezolid…………………….400mg
Pharmacological Group Other Antibacterial
Type of Form Form-5
Finished Product Specification Firm has claimed manufacturer‘s specification
Approval status of product in Zyvox 400 mg tablet by M/s Pharmacia and Upjohn Pharma
Reference Regulatory Authorities. (USFDA).
Me-too status Oxalid 400mg Tablets by M/s Aries Pharma (Reg. No. 82580)
 Decision: Approved with change of brand name & with Innovators specifications.
Brand Name +Dosage Form + Strength LINZ 600 mg Tablet
Linezolid…600mg
Diary No. Date of R& I & fee Dy. No. 10690: 22-03-2018 PKR 20,000/: 21-03-2018
Pharmacological Group Other Antibacterial
Type of Form Form-5
Approval status of product in Zyvox 600 mg film-coated tablets by Pharmacia Limited
Me-too status Linox 600 mg Tablet by M/S Nabi Qasim (Reg. No. 81180)

Brand Name +Dosage Form + Strength LINZ 100mg/5ml Oral Suspension
Composition Each 5ml of reconstituted suspension contains:
Linezolid…100mg
Pharmacological Group Antibacterial agent of Oxazolidinone class
Type of Form Form-5
Approval status of product in Zyvox Dry Suspension by Pharmacia (USFDA Approved).
Me-too status Nezolid 100mg Suspension by Searle (Reg. No. 050326).
Brand Name +Dosage Form + Strength Linz 2mg/1ml Infusion
Composition Each 100ml Vial contains:-
Linezolid………………….200mg
Pharmacological Group Oxazolidinone
Type of Form Form-5
Me-too status Linzol Infusion 200mg of M/s Regal Pharma, (Reg.#081997)
Remarks of the Evaluator Registration Board approved the applied formulation with
innovator‘s specifications in the light of decision taken in 271st
meeting, stated as under: ―In order to ensure, safety, efficacy and
quality of Linezolid infusion, Registration Board decided as
under;
i) All the Manufacturers of Linezolid Infusion shall follow the
packaging instructions of the innovator of the product i.e. M/s
Pfizer which has clearly mention the storage precautions in its
Product Information Leaflet (PIL).
Decision: Approved with change of brand name & with Innovators specifications.
―In order to ensure, safety, efficacy and quality of Linezolid infusion, Registration Board decided as
under;
 i) All the Manufacturers of Linezolid Infusion shall follow the packaging instructions of the inno vator
of the product i.e M/s Pfizer which has clearly mention the storage precautions in its Product
Information Leaflet (PIL). They will also make sure that the solution is kept correctly in its box and
foil wrapping in order to protect from light.‖
Brand Name +Dosage Form + Strength Lamowen 25 mg Tablet
Lamotrigine………………25mg
Pharmacological Group Anticonvulsant
Type of Form Form-5

Me-too status Lamictal 25mg tablet of M/s GSK (Reg. # 014918) (uncoated).
Remarks of the Evaluator Firm was asked to clarify that the firm applied for film-coated
tablet while the applied formulation in approved in reference
countries is uncoated. Firm in response submitted revised
formulation along with fee of 5000/ with deposit slip No.
1917511 dated 19.03.2019.
Lamotrigine………………50mg
Type of Form Form-5
Approval status of product in Lamictal 50 mg tablets by M/s The Wellcome FoundationLtd
Me-too status Lamotec Tablets 50 mg by M/s Rotex Medica Pakistan (Pvt) Ltd.
(Reg#070154)
1917512 dated 19.03.2019.
Lamotrigine…100mg
Type of Form Form-5
Approval status of product in Lamictal 100 mg tablets by M/s The Wellcome FoundationLtd
Me-too status Lamotec Tablets 100 mg by M/s Rotex Medica Pakistan (Pvt)
Ltd. (Reg#070155).
1917513 dated 19.03.2019.

Brand Name +Dosage Form + Strength OLAWEN 5 mg Tablet
Olanzapine…5mg
Type of Form Form-5
Me-too status Olanzyan 5 mg Tablets of M/s Roryan Pharma (Reg.#78590).
Brand Name +Dosage Form + Strength OLAWEN 10 mg Tablet
Olanzapine…10mg
Type of Form Form-5
Me-too status Olanzyan 5 mg Tablets of M/s Roryan Pharma (Reg. No. 78591).
Brand Name +Dosage Form + Strength FLOZAPINE 25/12 mg capsule
Fluoxetine HCl eq. to Fluxetine………..25mg
Olanzapine…………………………….12mg
Pharmacological Group Antipsychotic and SSRI
Type of Form Form-5
Approval status of product in Symbyax 12mg/25mg capsule by Eli Lilly (USFDAApproved).
Me-too status Olanzakson DS Capsule of M/s Akson (Reg. No. 81658)
573. Name and address of manufacturer / M/s NovaMed Pharmaceuticals (Pvt) Ltd. 28 Km Ferozpur Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Diapin 100mg SR tablet
Composition Each Sustained Release tablet contains:
Diclofenac sodium…………….100 mg
Type of Form Form-5

Approval status of product in Voltaren-XR, USFDA Approved.
Me-too status Rheunil SR 100mg Tablets by M/s Munawar Pharma
Reg.No.024585
GMP status Panel inspection was conducted on 22.01.2019 by panel, and
concluded as under:
―Firm Operating at good level of GMP.‖
574. Name and address of manufacturer / "M/s Usawa Pharmaceuticals, Plot No. 146, Special Industrial
Applicant Zone (EPZ) Risalpur, contract manufacturing by M/s Bio Lab
(Pvt) Ltd, Plot # 145, Industrial Triangle, Kahuta Road
Islamabad.
Brand Name +Dosage Form + Strength UD-3 Injection 5mg/ml
Composition Each ml Injection contains:
Cholecalciferol…………5mg (200,000IU)
Type of Form Form-5
Pack size & Demanded Price As per SRO, I x5
Approval status of product in VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution for
Reference Regulatory Authorities. injection ANSM, France approved
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg. No. 076115)
GMP status Panel Inspection of Applicant:
M/s Usawa Pharma.14.10.2016. GMP certificate issued.
Panel Inspection of Manufacturer:
M/s Bio Lab Pharma. 20.11.2017.
―The firm operating at fair compliance with GMP as of today.‖
Remarks of the Evaluator The firm has provided list of already approved products
registered for contract manufacturing i.e. 8 products and applied
products for contract manufacturing are 2.
The firm submitted that they have the following approved
sections: 1. Tablet (General Antibiotic) 2. Capsule (General
Antibiotic) 3. Capsule (cephalosporin) 4. Dry Powder Suspension
(cephalosporin).
575. Name and address of manufacturer / M/s Vision Pharmaceuticals (Pvt.) Ltd. Plot# 22-23, Industrial
Applicant Triangle, Kahuta Road Islamabad, contract manufacturing by
M/s Global Pharmaceuticals (Pvt.) ltd. Plot # 204-205, Industrial
Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Visopen IV Injection 500mg
Meropenum……….500mg
Pharmacological Group Anti-Bacterial Carbapenum
Type of Form Form-5
Pack size & Demanded Price As per SRO, 1‘S
Approval status of product in Merrem By M/s PFIZER (US FDA) approved.
Me-too status Mopen 500mg Injection by M/s Hilton Pharma Reg. No. 36429

GMP status Panel Inspection of Applicant: M/s Vision Pharma.11.02.2019.
GMP certificate issued.
Panel Inspection of Manufacturer: M/s Global Pharma.
11.10.2018 & 24.11.2018.GMP certificate issued.
Remarks of the Evaluator API also contains sodium carbonate.
The firm has provided list of already approved products
The firm submitted that they have 10 approved sections.
Brand Name +Dosage Form + Strength Visopen IV Injection 1000mg
Meropenum…………….1000mg
Pharmacological Group Anti-Bacterial Carbapenum
Type of Form Form-5
Pack size & Demanded Price As per SRO, 1‘S
Approval status of product in Merrem By M/s PFIZER (US FDA) approved.
Me-too status Mopen 1000mg Injection by M/s Hilton Pharma Karachi Reg.
No. 36427.
Brand Name +Dosage Form + Strength Enem IV Injection
Imipenem Monohydrate eq. to Imipenem………500mg
Cilastin Sodium eq. to Cilastin………………….50mg
Pharmacological Group Carbapenem
Type of Form Form-5
Pack size & Demanded Price As per SRO, 1‘s vial
Approval status of product in Imipenem/Cilastatin 500mg/500mg Powder for Solution for
Reference Regulatory Authorities. Infusion by M/s STRAVENCON Ltd. (PL-39655/0018). MHRA
Approved.
Me-too status Cilapen IV Injection by M/s Bosch Pharma. (Reg#048491)
Brand Name +Dosage Form + Strength Pizo IV Injection 2.25gm
Piperacillin (as Piperacillin Sodium)………2gm
Tazobactam (as Tazobactam Sodium)…….0.25gm
Type of Form Form-5
Me-too status Tanzo Injection 2.5 gm by Bosch Pharma Reg. No. 039593
 Decision: Approved with change of name.
Brand Name +Dosage Form + Strength Pizo IV Injection 4.5gm
Piperacillin (as Piperacillin Sodium)…………4gm
Tazobactam (as Tazobactam Sodium)………..0.50gm
Type of Form Form-5
Me-too status Tanzo Injection 4.5gm by Bosch Pharma Reg. No. 039439
 Decision: Approved with change of name.
580. Name and address of manufacturer / Regal Pharma Plot #2A, St#S-5 National Industrial Zones, Rawat
Brand Name +Dosage Form + Strength Qinreg 200mg Tablet
Hydroxychloroquine Sulphate………200mg

Type of Form Form-5
Approval status of product in Plaquenil 200mg Film coated tablet (MHRA Approved)
Me-too status HCQ 200mg tablets of GETZ (Reg. No. 045471).
GMP status Last inspection was conducted on 20.11.2017 by area FID, and
rated the firm operating at fair level of compliance with GMP as
of today.
Remarks of the Evaluator The Applied formulation in reference countries agencies is film
coated and firm applied for uncoated, however firm submitted
formulation for film coated.
The firm was asked to correct label claim and submit updated
form5.
The firm in response submitted same previous form5 for
uncoated and did not justify.
were adopted by the Registration Board.
Brand Name +Dosage Form + Strength Lepride 25mg Tablets
Levosulpride ………………….25mg
Type of Form Form-5
Finished Product Specification Manufacturer‘s specifications.
Approval status of product in Levidomed 25mg tablets of M/s Medochemie Ltd. approved by
Reference Regulatory Authorities. AIFA of Italy.
Me-too status Sulvoric 25mg of M/s High-Q, Karachi (Reg. No. 070484).
rated the firm operating at fair level of compliance with GMP as
of today.
Remarks of the Evaluator Applied formulation in reference countries agencies is film
coated and firm applied for uncoated. The firm was asked to
clarify.
Firm in response submitted same form5, formulation for uncoated
tablets.
Brand Name +Dosage Form + Strength Lepride 50 mg Tablets
Levosulpride ……………50mg
Pharmacological Group Antipsycotic
Type of Form Form-5
Finished Product Specification Manufacturer‘s specifications.
Approval status of product in Levidomed 50mg tablets of M/s Medochemie Ltd. approved by
Reference Regulatory Authorities. AIFA of Italy.
Me-too status Sulvoric 50mg of M/s High-Q, Karachi (Reg.#070485)
rated as ―The firm operating at fair level of compliance with
GMP as of today.‖
Remarks of the Evaluator Applied formulation in reference agencies is film coated and firm
applied for uncoated. The firm was asked to clarify.
tablets.
Brand Name +Dosage Form + Strength Cine 1mg Tablet
Cinitapride hydrogen tartrate eq. to cinitapride…1mg
Pharmacological Group Propulsives
Antidopaminergic prokinetic
Type of Form Form-5
Approval status of product in Cidine 1 mg uncoated tablet by ALMIRALL, SA (Spain
Me-too status Cidine Tablets by Highnoon Lab (Reg#052940).
rated as ―The firm operating at fair level of compliance with
GMP as of today.‖
Remarks of the Evaluator Applied formulation in reference agencies is film coated and firm
applied for uncoated. The firm was asked to clarify.
tablets.
584. Name and address of manufacturer / "M/s P.D.H Pharmaceuticals Pvt Ltd. 19 km, Ferozepur Road,
Applicant Lahore"
Brand Name +Dosage Form + Strength Orfit 120mg Capsule
Orlistat……………….120mg"
Pharmacological Group Lipase inhibitor
Type of Form Form-5
Pack size & Demanded Price 3 x10, As per SRO
Approval status of product in Beacita Capsule by Actavis (MHRA Approved).
Me-too status Orlifit Capsule by Getz Pharma Reg. No. 42390

GMP status Panel inspection was conducted on 20.09.2017 for the purpose of
renewal of DML, and concluded as under:-
―After thorough evaluation of documents and inspection of the
unit, panel decided to recommend the renewal of DML.
Remarks of the Evaluator  Submit source of Pellets.
 Submit Stability studies, Master formula & GMP of source.
 Firm did not reply yet.
 Submit source of Pellets.
 Submit Stability studies, Master formula & GMP of source.
Applicant Lahore"
Brand Name +Dosage Form + Strength Linzold 400mg Tablet
Linezolid………..400mg"
Pharmacological Group Antibacterial, Oxazolidinone
Type of Form Form-5
Finished Product Specification The firm has claimed manufacturer‘s spec.
Me-too status Ecasil Tablet of M/s Sami Pharmaceuticals (Reg. # 067162)
Applicant Lahore."
Brand Name +Dosage Form + Strength Linzold 600mg Tablet
Linezolid…600mg"
Type of Form Form-5
Approval status of product in Zyvox 600mg Tablet of Pharmacia & Upjohn (USFDA approved)
Me-too status Linexa Tablet 600mg by M/s. Cirin Pharma (Reg. # 073213)
Applicant Lahore."
Brand Name +Dosage Form + Strength Linzold 100mg/5ml Dry Suspension
Linezolid…100mg"
Type of Form Form-5
Pack size & Demanded Price 60ml, As per SRO
Approval status of product in Zyvox Dry Suspension by Pharmacia (USFDA Approved)
Me-too status Nezolid 100mg Suspension by Searle (Reg. No. 050326)
Applicant Lahore."
Brand Name +Dosage Form + Strength 3D Syrup
Vitamin D3………………..1000 IU"
Pharmacological Group Multivitamin
Type of Form Form5
Pack size & Demanded Price 120ml
Approval status of product in N/A
Me-too status Me-too could not be verified.
Remarks of the Evaluator Submit Me-too status with documentary evidence. Submit
International availability from reference countries agencies.
Applicant Lahore."
Brand Name +Dosage Form + Strength Kuin-Kid 125mg Dry Powder Suspension
Ciprofloxacin HCL Eq. to Ciprofloxacin………….125mg"
Pharmacological Group Antibacterial, Quinolones
Type of Form Form5
Me-too status Hiflox Dry suspension of M/s Hilton Pharma (Reg. # 067498).
Applicant Lahore."
Brand Name +Dosage Form + Strength Kuin-Kid 250mg Dry Powder Suspension
Ciprofloxacin HCL Eq. to Ciprofloxacin…………..250mg"
Pharmacological Group Antibacterial, Quinolones
Type of Form Form5
Me-too status Hiflox Dry suspension of M/s Hilton Pharma (Reg. # 067499).

 Decision: Approved with innovator‘s specifications. Diluent shall be provided as per innovator‘s
product.
Applicant Lahore."
Brand Name +Dosage Form + Strength Eazyflow 10mg Tablet
Rivaroxaban…………………10mg"
Pharmacological Group Anti-Thrombic agent
Type of Form Form5
Approval status of product in Rivaroxaban 10 mg film-coated tablets by Milpharm Limited.
Reference Regulatory Authorities. MHRA approved.
Me-too status Xaroban 10mg Tablet by M/s The Searle Company Ltd Kar. Reg.
No. 76284.
 Decision: Approved with change of brand name and with innovator‘s specifications
Applicant Highway, Phase-II, Karachi, Pakistan."
Brand Name +Dosage Form + Strength Windom 10mg Tablet
Composition "Each Film CoatedTablet Contains:
Domperidone………………….10mg"
Type of Form Form5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s. As per SRO
Approval status of product in Epodom 10mg Tablets of M/s Atlantic Pharmaceutical (Pvt.) Ltd,
Reference Regulatory Authorities. (Reg. 062326).
Me-too status Approved by TGA of Australia.
GMP status GMP inspection was conducted on 14.09.17 and GMP
compliance rated as good.
Brand Name +Dosage Form + Strength Winralex 10mg Tablet
Composition "Each Film coated Tablet Contains:
Escitalopram as Escitalopram Oxalate……….10mg"
Diary No. Date of R& I & fee Dy. No 14483 dated 18-04-2018
Rs.20,000/- Dated 17-04-2018
Type of Form Form5
Approval status of product in CIPRALEX 10 mg film-coated tablets, by H. Lundbeck A/S.
Reference Regulatory Authorities. approved by MHRA.
Me-too status Zavesca 10mg Tablets by Getz Pharma, Reg. No. 45279

Brand Name +Dosage Form + Strength Zolowin 20mg Capusle
Omperazole……………….20mg
Sodium Bicarbonate………1100mg"
Pharmacological Group Proton Pump Inhibitors/Antacid
Type of Form Form5
Pack size & Demanded Price 5‘s, 10‘s, 14‘s, 20‘s, 30‘s. As per SRO
Me-too status Encid 20mg by M/s Wilson Pharma Reg. No. 70224
Brand Name +Dosage Form + Strength Zolowin 40mg Capusle
Omperazole…………………..40mg
Sodium Bicarbonate…………1100mg"
Pharmacological Group Proton Pump Inhibitors/Antacid
Type of Form Form5
Pack size & Demanded Price 5‘s, 10‘s, 14‘s, 20‘s, 30‘s. As per SRO
Me-too status Encid 40mg by M/s Wilson Pharma Reg. No. 70225
Brand Name +Dosage Form + Strength Tifany 1mg Tablet
Ketotifen as Hydrogen Fumarate………….1mg"
Pharmacological Group Other Antihistamines
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s. As per SRO.
Approval status of product in ZADITEN Tablets 1mg by Alfasigma S.P.A. MHRA approved.
Me-too status Aria Tablet by m/s Highnoon laboratories Reg. No. 14742


Brand Name +Dosage Form + Strength Rifaxiwin 200mg Tablet
Rifaximin……………….200mg"
Type of Form Form5
Approval status of product in Xifaxan film coated tablet USFDA Approved.
Me-too status Nimixa 200mg By Getz Pharma.(Reg.#070734)
Brand Name +Dosage Form + Strength Rifaxiwin 550mg Tablet
Rifaximin…………………..550mg"
Type of Form Form5
Approval status of product in Xifaxan film coated tablet USFDA Approved.
Me-too status Nimixa 550mg By Getz Pharma. (Reg. No. 070733).
Brand Name +Dosage Form + Strength Wincer Capsule 50MG
Diacerein……………………….50mg"
Pharmacological Group Anti- Inflammatory Agent
Type of Form Form-5
Pack size & Demanded Price 5‘s, 10‘s, 20‘s, 30‘s. As per SRO.
Approval status of product in Diacerein Biogaran 50 mg Hard Capsule by M/s Biogaran
Reference Regulatory Authorities. (ANSM, France approved).
Me-too status Dibro 50mg capsules by M/s Winbrain Research Lab (R#071639)
Applicant Islamabad."
Brand Name +Dosage Form + Strength Sem 1mg Tablet
Eszopiclone…………………..1mg"
Pharmacological Group Benzodiazepine related drugs
Type of Form Form-5
Pack size & Demanded Price 1×10‘s, As per SRO
Approval status of product in Lunesta Tablet by Sunovion Pharms
Me-too status Clonexa 1mg Tablet by M/s Atco Laboratories Ltd R.No. 58428.
GMP status The firm was inspected on 19.09.2017 & 21.09.2017 &
concluded as: - ―The firm operating at very good level of GMP.‖
Type of Form Form-5
Approval status of product in Lunesta Tablet by Sunovion Pharms (USFDA Approved).
Me-too status Clonexa 1mg Tablet by M/s Atco Laboratories Ltd R.No. 58429.
Type of Form Form-5
Approval status of product in Lunesta Tablet by Sunovion Pharms, (USFDA Approved).
Me-too status Clonexa 1mg Tablet by M/s Atco Laboratories Ltd R.No. 58430
Brand Name +Dosage Form + Strength Grip 20mg/ml Oral Drops
Composition "Each ml Contains: -
Escitalopram as (Escitalopram Oxalate)………………20mg"

Type of Form Form-5
Approval status of product in Anisdis 20 mg/ml oral drops by Pharmacare, (MHRA Approved).
Me-too status Cipralex 20g/ml Drops by M/s Lundbeck Pakistan 9pvt) Ltd.
Reg. No. 066177
Remarks of the Evaluator Me-too could not be verified from available database. Firm was
asked to submit me-too evidence. Firm in reply submitted the
evidence, which was verified from available me-too data base.
 Decision: Approved
Brand Name +Dosage Form + Strength Grip 10mg/ml Oral Drops
Composition "Each ml Contains: -
Escitalopram as (Escitalopram Oxalate)………..10mg"
Type of Form Form-5
Pack size & Demanded Price 15ml, 30ml, 60ml. As per SRO.
Approval status of product in International availability could not be verified.
Me-too status Citanew Oral Drops by M/s Hilton Pharma Reg. No. 47485
authorities / agencies which were adopted by the Registration Board in its 275 th meeting.
605. Name and address of manufacturer / "M/s CKD Pharmaceuticals Pakistan Private Limited. Plot No.
Applicant 50/28, Korangi Industrial Area, Karachi."
Brand Name +Dosage Form + Strength Incosta 10mg Tablet
Domperidone Maleate Eq. to Domperidone…10mg"
Pharmacological Group Dopamine antagonist
Type of Form Form5
Finished Product Specification The firm has claimed Manufacturer specification.
Pack size & Demanded Price 5×10‘s, As per SRO.
Approval status of product in TGA Australia Approved.
Me-too status Epodom 10mg Tablets of M/s Atlantic Pharmaceutical (Pvt.) Ltd,
(Reg.# 062326).
GMP status 13.07.17 & 16.07.17.
Panel concluded as: Firm was considered to be operating at an
acceptable level of compliance with GMP guidelines.
 Decision: Approved with change of brand name and innovator‘s specifications.
Brand Name +Dosage Form + Strength Sukoon Tablet 300mg
Composition "Each Enteric Coated Tablet Contains:
Acetyl Salicyclic Acid (Aspirin)…………300mg"

Type of Form Form5
Pack size & Demanded Price 3×10‘s, As per approved.
Approval status of product in Aspirin 300mg tablet By M/s Alliance Pharmaceuticals (MHRA
Me-too status Me-Too status could not be verified from available data base.
GMP status 13.07.17 & 16.07.17.
Remarks of the Evaluator Firm was asked to provide Evidence of applied formulation/drug
already approved by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
Firm in reply submitted only Me-too without providing
international availability evidence, however given me-too is also
uncoated and firm applied for enteric coated.
Brand Name +Dosage Form + Strength Pass 3.35g/5ml Syrup
Lactulose………………….3.35g"
Pharmacological Group Laxative
Type of Form Form5
Pack size & Demanded Price 120ml, 240ml. As per SRO
Approval status of product in Duphalac syrup (MHRA approved)
Me-too status Laxum Syrup of M/s Hisun Pharmaceuticals, Swabi R.No.
64054.
GMP status 13.07.17 & 16.07.17.
Remarks of the Evaluator Validity of attached supplier‘s GMP is 12/2015.
 Decision: Deferred for provision of GMP of manufacturer of lactulose.
Brand Name +Dosage Form + Strength Combact 400mg Tablet
Moxifloxacin…400mg"
Pharmacological Group Fluoroquinolones
Type of Form Form-5
Finished Product Specification Manufacturer specification.
Pack size & Demanded Price 1×5‘s, As per SRO.
Approval status of product in AVELOX Tablets of USFDA approved
Me-too status Swismox 400mg Tablet of M/s Swiss, Karachi (Reg.#070659)
GMP status 13.07.17 & 16.07.17.

 Decision: Approved with change of brand name and innovator‘s specification.
Applicant 50/28, Korangi Industrial Area, Karachi"
Brand Name +Dosage Form + Strength H2Block 150mg Tablet
Ranitidine as HCL…………….150mg"
Type of Form Form-5
Pack size & Demanded Price 1×10‘s. As per SRO.
Me-too status Ranidol Tablets 150mg of M/s Fedro Pharmaceutical (R#079257)
GMP status 13.07.17 & 16.07.17.
610. Name and address of manufacturer / "M/s Ray Pharma Pvt. Ltd. S-58, S.I.T.E Karachi, Pakistan"
Applicant
Brand Name +Dosage Form + Strength Lotemax-T Eye Drops
Loteprednol Etabonate…………5mg
Tobramycin…………………….3mg"
Pharmacological Group Antibiotic & Corticosteroids.
Type of Form Form5
Pack size & Demanded Price 1×5ml,
Approval status of product in Zylet of (USFDA approved).
Me-too status Lotepred-T Ophthalmic Suspension by M/s Elko Pharma
Pakistan.70515
GMP status 14.03.2018, The firm is operating at Good level of GMP
compliance.
Remarks of the Evaluator The firm was asked to Submit documentary evidence for separate
dispensing hood for ophthalmic steroidal products.
 Decision: Deferred for following:
 Submit documentary evidence for separate dispensing hood for ophthalmic steroidal products.
611. Name and address of manufacturer / "M/s Ray Pharma Pvt. Ltd. S-58, S.I.T.E Karachi, Pakistan."
Applicant
Brand Name +Dosage Form + Strength Eitane Oral Drops
Polyethylene glycol…………………4mg
Propylene Glycol……………………3mg"
Pharmacological Group Lubricant
Type of Form Form5
Pack size & Demanded Price 15ml, As per SRO.
Approval status of product in Systane of Alcon, UK, OTC product (Daily Med)
Me-too status Corniwet Eye Solution of M/s Medicaids. # 076375
compliance.
612. Name and address of manufacturer / "M/s Ray Pharma Pvt. Ltd. S-58, S.I.T.E Karachi, Pakistan."
Applicant
Brand Name +Dosage Form + Strength Inflanec Eye Drops
Nepafenac………………..1mg"
Type of Form Form5
Pack size & Demanded Price 5ml, As per SRO
Approval status of product in AVANEP sterile ophthalmic suspension of ALCON Labs ,
Reference Regulatory Authorities. USA
Me-too status NEPATEK 0.1% Sterile Ophthalmic suspension.
compliance.
613. Name and address of manufacturer / "M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Applicant Area, Karachi, Pakistan."
Brand Name +Dosage Form + Strength Aczol 100mg Capsule
Itraconazole…………………100mg"
Type of Form Form5
Finished Product Specification The Firm has claimed manufacturer‘s spec.
Pack size & Demanded Price 4‘s. As per SRO.
Approval status of product in Itraconazole 100 mg capsules, hard by M/s Sandoz
Reference Regulatory Authorities. Limited (MHRA Approved).
Me-too status Rolac 100mg Capsules of Sami Pharmaceuticals, Reg. No. 24491
GMP status 03.08.2017, The firm is operating at an acceptable level of
compliance of GMP requirements at the time of inspection.
Brand Name +Dosage Form + Strength Glytec-M XR 50/500 mg Tablet
Sitagliptin as Phosphate……..…50mg
Metformin HCL………………..500mg"
Type of Form Form5
Me-too status Tagipmet XR 50/500 Table M/s Highnoon Labs Reg. No. 84649.

Remarks of the Evaluator Firm was asked to correct label claim.
The firm has applied for sustained release and also submitted
formulation for sustained released. Accordingly firm was asked
to submit COA, stability study data of three batches conducted in
Zone IV-A.
 Revision of label claim as per the reference product along with the submission of requisite fee.
 Correct pharmacological group.
 Submission of stability studies data of three batches as per Registration Board guidelines
approved in 278th meeting.
Sitagliptin Phosphate Monohydrate……..50mg
Metformin HCL…………………………1000mg"
Type of Form Form5
Me-too status Tagipmet XR by M/s Highnoon Labs. (Reg.# 084650)
Zone IV-A.
Sitagliptin Phosphate Monohydrate……….100mg
Metformin HCL……………………………1000mg"
Type of Form Form5
Approval status of product in Janumet Tablets by Merck (TGA approved)

Zone IV-A.
617. Name and address of manufacturer / "M/s Rasco Pharma. 5.5 Km, Raiwind Road, Lahore."
Applicant
Brand Name +Dosage Form + Strength Topzol 20mg Tablet
Pantoprazole Sodium Sesquihydrate Eq. to
Pantoprazole……20mg"
Pharmacological Group Proton Pump Inhibitors
Type of Form Form5
Pack size & Demanded Price As per SRO. 14‘s.
Approval status of product in USFDA Approved present as Protinix Delayed release tablet
Me-too status Panzet 20mg gastro resistant (Enteric coated) Tablet Reg #
081050
GMP status GMP certificate issued on the basis of inspection dated
22.02.2018.
618. Name and address of manufacturer / "M/s Rasco Pharma. 5.5 Km, Raiwind Road, Lahore."
Applicant
Brand Name +Dosage Form + Strength Topzol 40mg Tablet
Pantoprazole Sodium Sesquihydrate Eq. to
Pantoprazole……40mg"
Type of Form Form5
Approval status of product in USFDA Approved present as Protinix Delayed release tablet.
Me-too status Pantberg 40mg enteric coated Tablet Reg # 079782
22.02.2018.
 Decision: Approved with Innovator‘s specifications and change of brand name.
619. Name and address of manufacturer / "M/s Rasco Pharma. 5.5 Km, Raiwind Road, Lahore"
Applicant
Brand Name +Dosage Form + Strength Le-Tact 500mg/5ml Injection
Levetiracetam…………….500mg"
Type of Form Form-5
Pack size & Demanded Price 1×5ml. As per SRO.
Approval status of product in KEPPRA 500mg/5ml Injection of USFDA approved
Me-too status Lumark Injection M/s Searle Pak Reg. No.75873
22.02.2018.
620. Name and address of manufacturer / "M/s Winilton Pharmaceuticals Pvt Ltd. Plot No.45, Street No. S-
Applicant 5, National Industrial Zone, Rawat, Islamabad."
Brand Name +Dosage Form + Strength Piroxiwin 20mg Dispersible Tablet
Piroxicam Beta Cyclodextrin Eq. to Piroxicam………….20mg"
Pharmacological Group Anti-inflammatory and ant rheumatic products, non-steroids
(oxicams)
Type of Form Form-5
Pack size & Demanded Price 2×10. As per SRO
Approval status of product in CYCLADOL 20 mg scored tablet. ANSM approved.
Me-too status Utrahit-beta Tablet. Reg. No. 81355
GMP status 14.07.2017. Panel Inspection report. The firm is operating at Fair
level of GMP.
621. Name and address of manufacturer / "M/s Winilton Pharmaceuticals Pvt Ltd. Plot No.45, Street No. S-
Applicant 5, National Industrial Zone, Rawat, Islamabad."
Brand Name +Dosage Form + Strength Lorex 8mg Tablets
Lornoxicam………………………….8mg"
Type of Form Form-5
Pack size & Demanded Price 10‘s Tablets. As per SRO.
Approval status of product in Approved by EMA
Me-too status RecamTablet 8 mg by M/s Regal Pharmaceuticals (Reg.#081952)
GMP status 14.07.2017. Panel Inspection report.
The firm is operating at Fair level of GMP.
622. Name and address of manufacturer / "M/s Saydon Pharmaceutical Industries Pvt Ltd. 77-A, Hayatabad
Applicant Industrial Estate, Peshawar."
Brand Name +Dosage Form + Strength Sayfon 40/0.04 mg Injection
Composition "Each 4ml Ampoule Contains:
Phloroglucinol Hydrate………………40mg
Trimethyl phloroglucinol…………….0.04mg"
Pharmacological Group Gastrointestinal Anticholinergic
Type of Form Form5
Approval status of product in SPASFON, solution for injection in ampoule by M/s TEVA
Reference Regulatory Authorities. HEALTH, (ANSM Approved)
Me-too status Spasfon Injection 4ml by M/s Himont (Reg. # 018530).
GMP status 13th Feb 2018. The firm is considered to be operated at
acceptable level of compliance with GMP guidelines as per
Drugs Act 1976.
623. Name and address of manufacturer / "M/s Saydon Pharmaceutical Industries Pvt Ltd. 77-A, Hayatabad
Applicant Industrial Estate, Peshawar."
Brand Name +Dosage Form + Strength Sayfon 80/80 mg Tablet
Composition "Each Sugar Coated Tablet Contains:
Phloroglucinol DiHydrate …………………..80mg
Trimethyl phloroglucinol……………………80mg"
Pharmacological Group Gastrointestinal Anticholinergic
Type of Form Form5
Approval status of product in Approved in ANSM
Me-too status Anafortan plus tablet of M/s AGP Ltd. Karachi. Reg. No. 24504
Applicant Industrial Estate, Hattar."
Brand Name +Dosage Form + Strength B-Carb 5% 1ml Injection
Composition "Each ampoule of 1ml Contains:
Sodium Bicarbonate………………….50mg"
Pharmacological Group Irrigating solution.
Type of Form Form-5
Pack size & Demanded Price 1ml×10 ampoule. As per SRO.
Approval status of product in WHO recommended diluent for Artesunate Injection.
Me-too status Dasura 50mg/ml Injection by M/s Mediate Pharmaceutical (Pvt.)
Ltd (Reg#061962)
GMP status 04-09-2018 & 26-09-2018.
The panel unanimously recommends the renewal of DML
000614 by way of formulation granted to M/s Welmark KPK.
 Decision: Approved with BP specifications.
Applicant Industrial Estate, Hattar."
Brand Name +Dosage Form + Strength B-Carb 5% 100mg/2ml Injection
Composition "Each ampoule of 2ml Contains:
Sodium Bicarbonate…………….100mg"
Pharmacological Group Irrigating solution.
Type of Form Form-5
Pack size & Demanded Price 2ml×10 ampoule. As per SRO.
Approval status of product in Recommended in WHO list, as separate ampoule of 5% sodium
Reference Regulatory Authorities. bicarbonate solution diluent for Artesun 120 mg injection.
Me-too status Sodium bicarbonate injection of M/s Genix Pharma
(Reg#061962)
626. Name and address of manufacturer / "M/s Zafa Pharmaceuticals Laboratories Private Limited. L1/B
Applicant Block-22, Federal B industrial Area, Karachi."
Brand Name +Dosage Form + Strength Xynosine-F Nasal Spray
Fluticasone Propionate…………………50mcg"
Diary No. Date of R& I &fee Dy. No 14265 dated 17-04-2018 Rs.20,000/- Dated 16-04-2018
Pharmacological Group Decongestants (Corticosteroid)
Type of Form Form-5
Pack size & Demanded Price 15ml. As per SRO
Approval status of product in Flixonase Aqueous Nasal Spray by M/s GlaxoSmithKline UK
Me-too status Flexosone Nasal Spray by "Schazoo Laboratories, R.No 40863.
 Decision: Approved with BP specifications.
627. Name and address of manufacturer / "M/s Werrick Pharmaceuticals. 216-217, I-10/3, Industrial Area,
Brand Name +Dosage Form + Strength Gluset Plus 500mg Tablet
Sitagliptin as Phosphate Monohydrate……………..50mg
Metformin HCL…………………………………….500mg"
Type of Form Form-5
GMP status 07.12.2017 Very good level of GMP.
 Decision: Approved with innovator‘s Specifications.
628. Name and address of manufacturer / "M/s Werrick Pharmaceuticals. 216-217, I-10/3, Industrial Area,
Brand Name +Dosage Form + Strength Gluset Plus 1000mg Tablet
Sitagliptin as Phosphate Monohydrate………………50mg
Metformin HCL………………………………….1000mg"
Type of Form Form-5
Approval status of product in Janumet Tablets by Merck (TGA approved)
GMP status 07.12.2017 Very good level of GMP.
 Decision: Approved with innovator‘s Specifications.

629. Name and address of manufacturer / "M/s Global Pharmaceuticals Pvt Ltd. Plot # 204-205, Industrial
Applicant Triangle, Kahuta Road, Islamabad."
Brand Name +Dosage Form + Strength Emitant 40mg Capsule
Aprepitant……………………..40mg"
Pharmacological Group Anti-emetic
Type of Form Form-5
Pack size & Demanded Price 1‘s. As per SRO
Approval status of product in Emend ( USFDA Approved)
Me-too status Apritus 40mg Capsule Of M/S S.J&G Reg. No. 74885.
GMP status 12.07.2017 Good compliance level of GMP. GMP certificate
issued.
Aprepitant……………………..80mg"
Type of Form Form-5
Me-too status Apritus 80mg Capsule Of M/s S.J&G. Reg. No. 74886.
GMP status 12.07.2017 Good compliance level of GMP. GMP certificate
issued.
Aprepitant…………………..125mg"
Type of Form Form-5
Me-too status Apritus 80mg Capsule Of M/s S.J&G. Reg. No. 74886.
GMP status 12.07.2017 Good compliance level of GMP. certificate issued.
632. Name and address of manufacturer / "M/s Allmed Pvt Ltd. Plot No. 590, Sundar Industrial Estate,
Applicant Lahore, Pakistan."
Brand Name +Dosage Form + Strength Anomed 4mg/2ml Injection
Ondansetron as Ondansetron hydrochloride…………..4mg"

Type of Form Form-5
Approval status of product in Ondansetron 2 Mg/Ml Solution For Injection (MHRA
Me-too status Adosetron 4mg Injection by M/s Searl IV Solutions Pakistan
Reg. No. 78780.
GMP status 13-09-2017 Purpose: GMP Compliance Conclusion: Satisfactory
Remarks of the Evaluator The firm applied for 3 products and attached 2 deposit slips of
50,000 and 10,000 separately for 3 products. Among 3 products
one product named as Nitron Tablet has already been approved in
DRB meeting 283rd. Deposit slips were overwritten by another
product and firm was asked to clarify. Firm in response replied
that ―It was just because of wrong sentence written, that was
corrected by overwriting and further verified by statistical officer
DRAP.‖
 Decision: Approved with Innovator‘s specifications. Deposit slip shall be verified from Budget and
Account Division before issuance of Registration letter.
633. Name and address of manufacturer / "M/s Allmed Pvt Ltd. Plot No. 590, Sundar Industrial Estate,
Applicant Lahore, Pakistan."
Brand Name +Dosage Form + Strength Anomed 4mg/5ml Oral Solution
Ondansetron
Ondansetron as Ondansetron hydrochloride ………..4mg"
Pharmacological Group Anti-Emetic Serotonin (5HT3) Antagonist.
Type of Form Form-5
Pack size & Demanded Price 60ml. As per SRO
Approval status of product in Ondensetron oral solution by West-Ward Pharma (USFDA
Me-too status Ondanles by NeoMedics Pharma
GMP status 13-09-2017 Purpose: GMP Compliance Conclusion: Satisfactory
 Decision: Approved with Innovator‘s specifications. Deposit slip shall be verified from Budget and
Account Division before issuance of Registration letter.
Brand Name +Dosage Form + Strength Dexcin Cream
Dexamethasone Phosphate (As dexamethasone Phosphate)....1mg
Neomycin………………………………..3.5mg"
Pharmacological Group Antibiotic, Corticosteroids.
Type of Form Form-5
Pack size & Demanded Price 15g. As per SRO
Approval status of product in No evidence could be verified from reference agencies.
Me-too status Me-too evidence could not be verified from available database.
GMP status 11.10.2017 & 16.10.2017 Satisfactory level of GMP compliance.

Remarks of the Evaluator Submit international availability with same strength from
reference countries agencies.
Submit Me-too evidence with same strength with documentary
proof.
635. Name and address of manufacturer / "M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi Creek
Applicant Industrial Park, Karachi."
Brand Name +Dosage Form + Strength Duphil 400mg Tablet
Doxyfylline………………….400mg"
Pharmacological Group Anti-Asthmatic
Type of Form Form-5
Finished Product Specification USP Specs
Approval status of product in Doxofillina ABC 400 Mg Tablet Of (AIFA Italy Approved).
Me-too status Unifyline 400mg Tablets Of M/S Platinum Pharma Reg. No.
47179
GMP status 05.12.2017 Renewal of DML. Satisfactory level of GMP.
636. Name and address of manufacturer / "M/s Hicon Pharmaceuticals. 131-Industrial Estate, Hayatabad."
Applicant
Brand Name +Dosage Form + Strength Pericon 50mg Tablets
Eperisone Hydrochloride………………..50mg"
Pharmacological Group Other centrally acting agents
Type of Form Form-5
Finished Product Specification The Firm has claimed manufacturer‘s specification.
Pack size & Demanded Price 02×10‘s; 03×10‘s. As per SRO.
Approval status of product in Expose 50mg film coated tablets by ALFASIGMA S.P.A.
Reference Regulatory Authorities. (AIFA Italy Approved).
Me-too status Perispa 50 Mg Tablets by Platinum Pharma (Reg# 039302)
GMP status Routine GMP inspection was conducted on 26.07.2017.
Satisfactory level of GMP.
637. Name and address of manufacturer / "M/s Hilton Pharma Pvt Ltd. Plot No. 13-14, Sector 15, Korangi
Applicant Industrial Area, Karachi, Pakistan."
Brand Name +Dosage Form + Strength Vomifit 10/10 mg Tablet
Composition "Each Delayed Release Capsule Contains:
Doxylamine Succinate…………………10mg
Pyridoxine HCl…………………………10mg"
Pharmacological Group Doxylamine, combinations
Type of Form Form-5
Approval status of product in Diclegis delayed release tablets. US-FDA approved
Me-too status Nausidox 10mg/10mg Tablet. Reg. No. 76292
GMP status 19.07.2017.
Routine GMP inspection. Satisfactory level of GMP compliance.
 Decision: Approved with Innovator‘s specifications and change of brand name.
638. Name and address of manufacturer / "M/s CCL Pharmaceuticals (Pvt.) Ltd. 62-Industrial Estate, Kot
Applicant Lakhpat, Lahore."
Brand Name +Dosage Form + Strength Snare 2gm IV Injection
Ceftriaxone Sodium eq. to ceftriaxone……………2gm"
Pharmacological Group Third generation cephalosporin antibiotic
Type of Form Form-5
Pack size & Demanded Price 1×1. As per SRO.
Approval status of product in Rocephin (IV/IM) Injection 2gm By M/s Roche ProductsLimited
Reference Regulatory Authorities. (MHRA approved).
Me-too status Triax 2gm Injection of M/s. Wilshire Laboratories
GMP status 08.03.2017 & 31.03.2017 GMP report conclusion not available.
639. Name and address of manufacturer / "M/s Genix Pharma Pvt. Ltd. 44,
Applicant 45-B, Korangi Creek Road, Karachi, 75190, Pakistan."
Brand Name +Dosage Form + Strength Decon 50mcg/actuation Nasal Spray
Composition "Each actuation Contains:
Mometasone Furoate Monohydrate Eq. to Mometasone
Fumarate……………………………………50mcg"
Type of Form Form-5
Finished Product Specification The Firm has claimed manufacturer‘s specification
Pack size & Demanded Price Anti-allergic
Approval status of product in Nasonex® 50 micrograms/actuation Nasal spray, suspension.
Reference Regulatory Authorities. MHRA approved.
Me-too status Hivate Nasal Spray By M/s Saffron Pharma Reg. No. 60352
GMP status 16.02.2018. Satisfactory level of compliance.
 Decision: Deferred for confirmation of manufacturing facility.
640. Name and address of manufacturer / "M/s Siam Pharmaceuticals. 217, Industrial Triangle, Kahuta
Applicant Road, Islamabad By
M/s Vision Pharmaceuticals. Plot#22,23, Industrial Triangle,
Kahuta Road, Islamabad."
Brand Name +Dosage Form + Strength Omitid 40mg IV Injection
Omeprazole as Sodium…40mg"
Type of Form Form-5
Approval status of product in MHRA Approved.
Me-too status Risek 40mg Infusion by Getz Pharma Reg. No. 24170.
GMP status Panel Inspection of Applicant:
M/s Siam, Pharma: -
16.02.2018. Recommended grant of renewal of DML.
Panel Inspection of Manufacturer:
M/s Vision Pharma.
26.01.2018. Good level of compliance. GMP certificate granted.
641. Name and address of manufacturer / "M/s Siam Pharmaceuticals. 217, Industrial Triangle, Kahuta
Applicant Road, Islamabad By
M/s Vision Pharmaceuticals. Plot # 22, 23, Industrial Triangle,
Kahuta Road, Islamabad."
Brand Name +Dosage Form + Strength Esiam 40mg IV Injection
Esomeprazole as Sodium………………..40mg"
Type of Form Form-5
Approval status of product in MHRA Approved.
Me-too status Nexum IV 40mg Injection by Getz Pharma Reg. No. 50651.
642. Name and address of manufacturer / "M/s Lisko Pakistan Pvt Ltd. L-10-D, Block 21, Shaheed Rashid
Applicant Minhas Road, F.B. Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Nebilol 5mg Tablet
Nebivolol as HCL……………….5mg"
Pharmacological Group Beta Blockers
Type of Form Form-5
Pack size & Demanded Price 10s, 14s, 20s, 28s, 30s. As per SRO
Me-too status Nebix Tablets of M/s. Highnoon Laboratories (Reg.#062777).
GMP status 24-04-2018. Satisfactory level of cGMP compliance. (Show
cause notice revoked on 27-04-2018).‖
Brand Name +Dosage Form + Strength Sipro XR 500mg Tablet
Ciprofloxacin as HCL……………….500mg"

Type of Form Form-5
Pack size & Demanded Price 5‘s, 10‘s, 14‘s, 20‘s. As per SRO.
Approval status of product in Ciprofloxacin 500 mg TabletsBy DR REDDYS LABS LTD. US
Reference Regulatory Authorities. FDA Approved.
Me-too status Ciprin XR Tablets 500 mg by M/s Werrick Pharmaceuticals
(Reg#044686).
Remarks of the Evaluator The applied product is not as per reference product.
 Decision: Deferred for revision of formulation as per US FDA approved reference product, since the
reference product is Bi-layered tablet, while firm has applied for single layered tablet. Furthermore
evidence of belayed tablet machine is also required to be submitted.
Brand Name +Dosage Form + Strength Co-Allset 150/12.5 mg Tablet
Irbesartan…………………….150mg
Hydrochlorothiazide…………12.5mg"
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form-5
Pack size & Demanded Price 5‘s, 10‘s, 14‘s, 20‘s. As per SRO
Approval status of product in Avalide tablet of Sanofi Aventis, USFDA approved.
Me-too status COAPROVEL tablet of Sanofi Aventis Reg. No. 043095.
Brand Name +Dosage Form + Strength Metrol 50mg Tablet
Metoprolol Tartrate………………..50mg"
Pharmacological Group Beta Blocker
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s. As Per SRO.
Approval status of product in Lopressor Tablets 50mg by M/s Novartis, FDA approved.
Me-too status Carsel Tablets 50mg by M/s Lahore Chemical and
Pharmaceuticals Reg. No. 24369.
Brand Name +Dosage Form + Strength Metrol 100mg Tablet
Metoprolol Tartrate…………………….100mg"
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s. As Per SRO.
Approval status of product in Metoprolol tartrate 100mg of Milpharm, MHRA Approved.
Me-too status Carsel Plus 100mg tablet of M/s Unimark pharmaceuticals Reg.
No. 38008
a. New/Additional Section(s)
01Molecule/02 Products
647. Name and address of manufacturer / M/s Wilshire Laboratories, 124/A, Kotlakhpat, Indus: Area,
Applicant Township scheme, Lahore.
Brand Name +Dosage Form + Strength Zune Insta 20mg Sachet
Composition Each Sachet contains:
Esomeprazole enteric coated pellets 22.5% w/w............20mg
Diary No. Date of R& I & fee Dy. No. 1326, 20-07-2018; Fee in PKR: 100,000/-17-07-2018.
Pharmacological Group Anti-ulcerative.
Type of Form Form-5
Finished Product Specification Innovator‘s Specifications.
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 28‘s, 30‘s, 40‘s / As per policy of DRAP.
Me-too status Somezol by Bosch Pharma Karachi. (Reg. # 081611).
GMP status Date of Inspection: 27-08-18, 05-10-18, 06-11-18.
Recommendations:
The firm Wilshire Labs Lahore evaluated with respect to
productions operations, personal, documentations, Quality
assurance and quality control etc. Based on observations the firm
was found to be operating at satisfactory level of GMP
compliance at the time of inspections.
Remarks of the Evaluator Source of pellets: PRECISE CHEMIPHARMA PRIVATE
LIMITED (710550), GUT NO. 215/1 & 215/2, KHATWAD
PHATA, ATPOST-TALEGAON, TAL-DINDORI, DIST.
NASHIK-422202, MAHARASHTRA, INDIA.
Firm Submitted: -
1. GMP Certificate (Valid upto 27-02-2022).
2. CoAs.
3. Stability studies of three batches for 36 months of real time.
Decision: Approved.
648. Name and address of manufacturer / M/s Wilshire Laboratories, 124/A, Kotlakhpat, Indus: Area,
Applicant Township scheme, Lahore.
Brand Name +Dosage Form + Strength Zune Insta 20mg Sachet
Esomeprazole enteric coated pellets 22.5% w/w.....20mg
Diary No. Date of R& I & fee Dy. No. 1326, 20-07-2018; Fee in PKR: 100,000/-17-07-2018.
Pharmacological Group Anti-ulcerative.
Type of Form Form-5
Finished Product Specification Innovator‘s Specifications.
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 28‘s, 30‘s, 40‘s / As per policy of DRAP.
Me-too status Somezol by Bosch Pharma Karachi. (Reg. # 081611).
Remarks of the Evaluator Source of pellets: PRECISE CHEMIPHARMA PRIVATE
LIMITED (710550), GUT NO. 215/1 & 215/2, KHATWAD
PHATA, ATPOST-TALEGAON, TAL-DINDORI, DIST.
NASHIK-422202, MAHARASHTRA, INDIA.
Firm Submitted: -
1. GMP Certificate (Valid upto 27-02-2022).
2. COAs.
3. Stability studies of three batches for 36 months of real time.
Decision: Approved.
b. New DML:
Following registration dossiers have been received dated 07/03/ 2019 stating that the firm has been
granted approval of new DML by way of formulation by Central Licensing Board in its 269 th meeting
for following thirteen (13) sections.
1. Tablet section (General)
2. Capsule section (General)
3. Cream/Ointment/Gel section
4. Oral liquid syrup section (General)
5. Dry powder oral suspension section (General)
6. Liquid Sterile Ampoule section (General)
7. Liquid Sterile Ampoule section (psychotropic)
8. Tablet section (psychotropic)
9. Sterile Ampoule section (steroid)
10. Sterile infusion/small volume vial section (General)
11. Dry Powder for Injection (Cephalosporin)
12. Capsule section (Cephalosporin)
13. Dry powder oral suspension section (Cephalosporin)
The following applications have been evaluated and presented before the Board.
S.No. Section No. of Products No. of Molecules
1 Dry Powder for Injection (Cephalosporin) 15 5
2 Dry powder oral suspension section (Cephalosporin) 9 5
3 Capsule section (Cephalosporin) 6 4
4 Sterile infusion/small volume vial section (General 8 8
5 Liquid Sterile Ampoule section (General) 12 10

Dry Powder for Injection (Cephalosporin)05 Molecules/15 Products
649. Name and address of manufacturer "M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
/Applicant National Industrial Zone, Rawat, Islamabad, Pakistan"
Brand Name + Dosage Form + Strength Iqupam 500mg IV Injection
Cefepime HCL with L-Arginine Eq. to
Cefepime……………….……………….500mg"
Diary No. Date of R & I & Fee Form-5 Dy. No 15650 dated 07-03-2019
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Pack Size & Demanded Price As per SRO.
Approval Status of product in Reference Cefipime hydrochloride 500mg Injection by M/s Hospira, Inc.
Regulatory Authorities (USFDA approved)
Me-too Status Novapime injection 500mg of M/s Novamed Pharmaceuticals.

Reg. No. 59905
GMP Status 19.02.2019. Panel inspection for the purpose of grant of DML.
Panel recommended for grant of DML.
Decision: Approved.
656. Name and address of manufacturer "M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
/Applicant National Industrial Zone, Rawat, Islamabad, Pakistan"
Brand Name + Dosage Form + Strength Iqupam 1GM IV Injection
Cefepime HCL with L-Arginine Eq. to
Cefepime………………..1000mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Maxipime 1gm of Hospira Inc., USA (USFDA).
Me-too Status Novapime Injection 1gm of M/s Novamed Pharmaceuticals.
Reg. No. 59906.
GMP Status As recorded for above application
Decision: Approved.
657. Name and address of manufacturer / "M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
Applicant National Industrial Zone, Rawat, Islamabad, Pakistan"
Brand Name + Dosage Form + Strength C-Trix 250mg IM Injection
Ceftriaxone as Ceftriaxone sodium…250mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Ceftriaxone 250mg (IM) by Lupin Pharmaceuticals Inc.
Regulatory Authorities USFDA approved.
Me-too Status Unixone Injection (ceftriaxone Sodium) 250mg IM by Caliph
Pharmaceuticals (Pvt.) Ltd. Reg. No. 82556
Decision: Approved.
Brand Name + Dosage Form + Strength C-Trix 250mg IV Injection
Ceftriaxone as Ceftriaxone Sodium……………250mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Rocephin I.V injection of (MHRA approved)
Me-too Status Stracef 250mg I.V. M/s Swiss Pharma Karachi. Reg. No. 42467

Decision: Approved.
Brand Name + Dosage Form + Strength C-Trix 500mg IV Injection
Ceftriaxone as Ceftriaxone Sodium…………….500mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Rocephin I.V injection of (MHRA approved)
Me-too Status Rocephin Roche 500mg IV INJ By M/s Roche Pharma Karachi.
Reg. No. 8435.
Decision: Approved.
Brand Name + Dosage Form + Strength C-Trix 500mg IM Injection
Ceftriaxone as Ceftriaxone Sodium………….500mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Rocephin powder for solution for injection by Roche (MHRA
Regulatory Authorities Approved).
Me-too Status Rocephin Roche 500mg IM INJ By M/s Roche Pharma
Karachi. Reg. No. 8434
Decision: Approved.
Brand Name + Dosage Form + Strength C-Trix 1g IV Injection
Ceftriaxone as Ceftriaxone Sodium………….1000mg"
Rs.20,000/- Dated 07-03-2019
Type of Form Form5
Approval Status of product in Reference Rocephin powder for solution for injection by Roche (MHRA
Regulatory Authorities Approved).
Me-too Status Rocephin Roche 1000mg IV INJ By M/s Roche Pharma
Karachi. Reg. No. 8437

Decision: Approved.
Brand Name + Dosage Form + Strength C-Trix 2g IV Injection
Ceftriaxone as Ceftriaxone Sodium……….2000mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Rocephin IV Injection 2gm By M/s Roche Products Limited
Regulatory Authorities (MHRA approved).
Me-too Status Titan 2gm IV Injection by M/S Macter Pharma (Reg. No.
075825)
Decision: Approved.
Brand Name + Dosage Form + Strength C-Tox 250mg IV Injection
Cefotaxime as Sodium…………………..250mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Claforan Injection 250mg by M/s Aventis Pharma Limited
Regulatory Authorities (MHRA Approved).
Me-too Status Getex Injection 250mg by M/s Amarant Pharmaceuticals Reg.
No. 80277
Decision: Approved.
Cefotaxime as Sodium…500mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Me-too Status Getex Injection 500mg by M/s Amarant Pharma R.No. 80278
Decision: Approved.

Cefotaxime as Sodium………..1gm"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Claforan Injection 1gm by M/s Aventis Pharma Limited
Me-too Status Getex Dry powder Injection 1gm by M/s Amarant from
Medicaid, Karachi (Reg#080279).
Decision: Approved.
Brand Name + Dosage Form + Strength Forfo 500mg IV Injection
Ceftazidime as Pentahydrate…………….500mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Approved by MHRA of UK.
Me-too Status Vegazid 500mg Injection of Vega Pharmaceuticals.
Decision: Approved.
Brand Name + Dosage Form + Strength Forfo 1000mg IV Injection
Ceftazidime as Pentahydrate…1gm"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Approved by MHRA of UK
Me-too Status Panacef Injection 1gm by M/s CCL (Reg. No. 023986)
Decision: Approved.
Brand Name + Dosage Form + Strength Sul-Fort 1000mg IV/IM Injection
Cefoperzone as Sodium…500mg
Sulbactam as Sodium…500mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Finished Product Specification JP
Approval Status of product in Reference Approved by PMDA-Japan
Me-too Status Cebac Injection 1gm by M/s Bosch (Reg#037630))
Decision: Approved with JP specifications.
Brand Name + Dosage Form + Strength Sul-Forte 2g IV Injection
Cefoperazone as Sodium………………..1000mg
Sulbactam as Sodium……………………1000mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Approved in Europe (Poland, Slovakia, Czech Republic) by
Regulatory Authorities EMA.
Me-too Status Sulzone 2gm Injection by M/s Biocare Pharmaceuticals (Reg.
No. 028469).
Dry powder oral suspension section (Cephalosporin)
05 Molecules/09 Products
Brand Name + Dosage Form + Strength Saclo 125mg/5ml Dry Powder Suspension
Composition "Each 5ml of Suspension Contains:
Cefaclor as Monohydrate………..125mg"
Diary No. Date of R & I & Fee Dy. No 15633 dated 07-03-2019 Rs.20,000/- 06-03-2019
Type of Form Form5
Approval Status of product in Reference Cefaclor 125mg/5ml of (MHRA approved).
Me-too Status Sac-Lor 125mg/5ml Dry Powder Suspension of M/s Semos
Pharma. Reg. No. 81617.
Decision: Approved.
Brand Name + Dosage Form + Strength Saclo 250mg/5ml Dry Powder Suspension
Cefeclor as Monohydrate………….250mg"
Diary No. Date of R & I & Fee Dy. No 15634 dated 07-03-2019
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Cefaclor 250mg/5ml powder for oral suspension of MHRA
Regulatory Authorities approved
Me-too Status Sac-Lor 250mg/5ml Dry Powder Suspension of M/s Semos
Pharma. Reg. No. 81618.
Decision: Approved.
Brand Name + Dosage Form + Strength C-Pod 50mg/5ml Dry Powder Suspension
Cefpodoxime as Proxetil…………..50mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Cefpodoxime proxetil 50mg / 5 ml powder for oral suspension
Regulatory Authorities of USFDA approved.
Me-too Status Qink Dry Suspension 50mg/5ml of M/s Wilshire Laboratories
Lahore Reg. No. 60519.
Decision: Approved.
Brand Name + Dosage Form + Strength C-Pod 100mg/5ml Dry Powder Suspension
Cefpodoxime as Proxetil…100mg"
Diary No. Date of R & I & Fee Dy. 58hyNo 15636 dated 07-03-2019
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Cefpodoxime proxetil 100mg / 5 ml powder for oral suspension
Regulatory Authorities of USFDA approved.
Me-too Status Qink Dry Suspension 100mg/5ml of M/s Wilshire Laboratories
Lahore Reg. No. 53636
Decision: Approved.
Brand Name + Dosage Form + Strength Fedric 125mg/5ml Dry Suspension
Cefadroxil as Monohydrate………….125mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference ORACEFAL powder for oral suspension (ANSM Approved)
Me-too Status Evacef Suspension 125mg/5ml of M/s Highnoon Laboratories
Reg. No. 11213
Decision: Approved.
Brand Name + Dosage Form + Strength Fedric 250mg/5ml Dry Powder Suspension
Cefadroxil as Monohydrate…………………250mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form5
Approval Status of product in Reference Cefadroxil 250mg/5ml of (USFDA approved).
Me-too Status Evacef Suspension 250mg/5ml of M/s Highnoon Laboratories
Reg. No. 11214.
Decision: Approved.
Brand Name + Dosage Form + Strength Ziq 100mg/5ml Dry Suspension
Composition "Each 5ml of Suspension Contains:-
Cefixime as Trihydrate…………..100mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form-5
Pack Size & Demanded Price As pee SRO
Approval Status of product in Reference Suprax of Sanofi Aventis, USFDA
Me-too Status Cefim suspension of M/s Hilton Pharma (Reg. No. 022108).
Decision: Approved.
Brand Name + Dosage Form + Strength Ziq 200mg/5ml Dry Suspension
Cefixime as Trihydrate………….200mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form-5
Approval Status of product in Reference USFDA Approved
Me-too Status Cefim-Ds suspension of M/s Hilton Pharma (Reg.# 029082).
Decision: Approved.
Brand Name + Dosage Form + Strength Rediq 250mg/5ml Dry Powder Suspension
Composition "Each 5ml of Reconstituted Suspension Contains:
Cephradine as Monohydrate…250mg/5ml"
Rs.20,000/- Dated 06-03-2019
Type of Form Form-5
Approval Status of product in Reference Approved in MHRA(Powder for Syrup).
Me-too Status Apacef 250 mg/5ml Dry Powder Suspension of ApexPharma
Pharma Reg. No. 73542
Decision: Approved.
Capsule section (Cephalosporin)
04 Molecules/ 06 products
Brand Name + Dosage Form + Strength Ziq 400mg Capsule
Cefixime as Trihydrate………………..400mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form-5
Approval Status of product in Reference Suprax 400mg capsule of Sanofi Aventis, USFDA
Me-too Status Cefiget capsule 400mg of GETZ Pharma
Brand Name + Dosage Form + Strength Fedric 500mg Capsule
Cefadroxil as Monohydrate……………..500mg"
Rs.20,000/- Dated 06-03-2019

Type of Form Form-5
Approval Status of product in Reference Cefadroxil 500 mg capsules, hard (containing Cefadroxil as
Regulatory Authorities monohydrate 500 mg) by Sandoz Ltd. Approved by MHRA.
Me-too Status Galen 500mg Capsule by Ankaz Pharma Karachi. Reg. No.
70647
Decision: Approved.
Brand Name + Dosage Form + Strength Rediq 250mg Capsule
Composition "Each Hard Gelatin Capsule Contains:-
Cephradine monohydrate eq. to
Cephradine……………250mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form-5
Approval Status of product in Reference Cephradine 250mg Capsule by TEVA PHARMA USA
Regulatory Authorities (USFDA)
Me-too Status Zasinol 250mg Capsule (080643)
Decision: Approved.
Brand Name + Dosage Form + Strength Rediq 500mg Capsule
Cephradine Monohydrate eq. to Cephradine ………….500mg"
Rs.20,000/- Dated 06-03-2019
Type of Form Form-5
Approval Status of product in Reference Cephradine 500mg Capsule by TEVA PHARMA USA
Regulatory Authorities (USFDA)
Me-too Status Zasinol 250mg Capsule (080644)
Decision: Approved.
Brand Name + Dosage Form + Strength Saclo 250mg Capsule
Cefeclor as Monohydrate………….250mg"
Diary No. Date of R & I & Fee Dy.#15625 dated 07-03-2019 Rs.20,000/- Dated 06-03-2019
Pharmacological Group Second-generation cephalosporins.
Type of Form Form-5

Pack Size & Demanded Price As per SRO
Approval Status of product in Reference Cefaclor Capsules 250mg (Cefaclor monohydrate Ph Eur Eq. to
Regulatory Authorities 250mg of Cefaclor) by Strides Pharma UK Ltd. Approved by
MHRA.
Me-too Status Deduclol 250mg Capsule by Martin Dow Karachi. R.# 80640
Decision: Approved.
Brand Name + Dosage Form + Strength Saclo 500mg Capsule
Cefeclor as Monohydrate……………..500mg"
Diary No. Date of R & I & Fee Dy. No 15626 dated 07-03-2019 Rs.20,000/- Dated 06-03-
2019
Pharmacological Group Second-generation cephalosporins
Type of Form Form-5
Approval Status of product in Reference Cefaclor Capsules 500mg (Cefaclor monohydrate Eq. to 500mg
Regulatory Authorities of Cefaclor) by Kosei Pharma UK Limited. Approved by
MHRA
Me-too Status Deduclol 500mg Capsule by Martin Dow Karachi. R.# 80639
Decision: Approved.
Sterile infusion/small volume vial section (General)
08 Molecules/ 08 Products.
Brand Name + Dosage Form + Strength Linca 600mg/2ml Ampoule
Composition "Each 2ml Vial Contains:
Lincomycin Hydrochloride Monohydrate Eq. to
Lincomycin…600mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Antibiotic,
Type of Form Form-5
Approval Status of product in Reference LINCOCIN 600mg/2ml (Vial) solution for injection by M/s
Regulatory Authorities Pharmacia and Upjohn (USFDA Approved).
Me-too Status Dds Lincomycin 600mg Injection by M/s Global Pharma,
Reg. No. 32155
Decision: Deferred for confirmation of manufacturing facility for 2ml vial.
Brand Name + Dosage Form + Strength Oflix 200 mg / 100ml Injection
Composition "Each 100ml Injection Contains:
Ofloxacin ……. 200mg"

Rs.20,000/- Dated 07-03-2019
Type of Form Form-5
Pack Size & Demanded Price 01×100ml. As per SRO.
Approval Status of product in Reference Tarivid Infusion 2mg/ml (MHRA approved)
Me-too Status Anacaine Injection by M/s Akson Pharma. (Reg.# 037614)
Decision:Approved with Innovator‘s specifications.
Brand Name + Dosage Form + Strength Imidol 5mg/ml IV Infusion
Composition "Each 100ml infusion Contains:
Metronidazole…………….500mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Anti-amoebic
Type of Form Form-5
Pack Size & Demanded Price 100ml. As per SRO.
Approval Status of product in Reference Metronidazole Infusion (MHRA Approved)
Me-too Status Resgyl Infusion 500 mg / 100 ml by M/s Rasco Pharma
Decision: Approved with BP specifications.

Brand Name + Dosage Form + Strength Roxil 2mg / ml Intravenous Infusion
Composition "Each 100ml Infusion Bottle Contains:
Ciprofloxacin lactate eq. to ciprofloxacin ……. 200mg"
Rs.20,000/- Dated 07-03-2019
Type of Form Form-5
Approval Status of product in Reference Ciprofloxacin 2 mg/ml Solution for Infusion by M/s Hospira
Regulatory Authorities UK Ltd (MHRA).
Me-too Status Reflox Infusion of M/s Regal Pharmaceutical.
Decision: Approved.
Brand Name + Dosage Form + Strength I-Quin 5mg /ml Intravenous Infusion
Levofloxacin Hemihydrate eq. to Levefloxacin ……. 500mg"
Rs.20,000/- Dated 07-03-2019

Type of Form Form-5
Pack Size & Demanded Price 1 x 100ml: As per SRO
Approval Status of product in Reference Levofloxacin solution for infusion 500mg/100ml (Vial) by
Regulatory Authorities Hikma Farmacêutica (Portugal), S.A (MHRA Approved).
Me-too Status Levaquin 500mg I.V Injection by Barrett Hodgson Reg.#
023875

Brand Name + Dosage Form + Strength Avelux 1.6mg/ml Intravenous Infusion
Moxifloxacin as Hcl………………160mg"
Rs.20,000/- Dated 07-03-2019
Type of Form Form-5
Approval Status of product in Reference Avelox 400mg/250ml by Bayer Pharma. MHRA Approved.
Regulatory Authorities International availability from reference countries agencies
with applied strength and pack size could not be verified.
Me-too Status Cinmox Infusion 1.6mg by M/s nexus Pharma Reg. No. 61596
Remarks of the Evaluator International availability from same reference countries
agencies with applied strength and pack size could not be
verified.
International availability from reference countries agencies with applied strength and pack size
could not be verified.
Brand Name + Dosage Form + Strength P-Mol 10mg/ml Intravenous Infusion
Paracetamol…………….1000mg"
Rs.20,000/- Dated 07-03-2019
Type of Form Form-5
Approval Status of product in Reference Perfalgan 10mg/ml, solution for infusion (MHRA approved).
Me-too Status Provas Infusion 10mg/ml of M/s Sami Pharma Reg. No. 53223
Decision: Approved.
Brand Name + Dosage Form + Strength Gentle 80mg/2ml Injection
Composition "Each 2ml Glass Vial Contains:
Gentamicin Sulphate……………….80mg"
Type of Form Form-5
Approval Status of product in Reference Gentamicin Injection by M/s Fresenius Kabi USA, LLC
Me-too Status Genta Injections by m/s Epoch Pharma Reg. No. 47130
Decision: Deferred for confirmation of manufacturing facility for 2ml vial.

Liquid Sterile Ampoule section (General)
10Molecules/12 Products
Brand Name + Dosage Form + Strength Ayanol 5mg/ml Injection
Cholecalciferol…………..5mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Vitamin D
Type of Form Form-5
Approval Status of product in Reference Vitamin D3 Good 200,000 IU / 1 ml IM solution for injection
Regulatory Authorities of
( ANSM France approved)
Me-too Status Calciferol Injection M/s Global Pharmaceuticals.
Decision: Approved.
Brand Name + Dosage Form + Strength Water for Injection 5ml
Sterile Water for Injection……………….5ml"
Pharmacological Group Diluent/Solvent
Type of Form Form-5
Pack Size & Demanded Price 5ml ×10 Ampoule, 5ml ×100 Ampoule, 5ml ×1000 Ampoule.
As per SRO.
Approval Status of product in Reference Approved in MHRA
Me-too Status Aqua R ampoule by M/s Regal Pharmaceuticals
(Reg#082010).
Decision: Approved.
Brand Name + Dosage Form + Strength Water for Injection 10ml
Sterile Water for Injection……………10ml"

Rs.20,000/- Dated 07-03-2019
Pharmacological Group Diluent/Solvent
Type of Form Form-5
Pack Size & Demanded Price 10ml ×10 Ampoule, 10ml ×100 Ampoule, 10ml ×1000
Ampoule. As per SRO.
Approval Status of product in Reference Approved in MHRA
Me-too Status Water for injection 10ml by M/s Novamed (Reg#076972)
Decision: Approved.
Brand Name + Dosage Form + Strength Nevitra 500mg/5ml Injection
Levetiracetam…………….500mg"
Rs.20,000/- Dated 07-03-2019
Type of Form Form-5
Pack Size & Demanded Price 1‘s & 10‘s. As per SRO.
Approval Status of product in Reference USFDA approved
Me-too Status Eplipsa 500mg/5ml Injection of M/s Helix (Reg.#075918)
Decision: Approved.
Brand Name + Dosage Form + Strength Katro 30mg/ml Injection
Ketorolac Tromethamine……………..30mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Analgesic, anti-inflammatory
Type of Form Form-5
Pack Size & Demanded Price 02x05 ampoules, 50 ampoules & 100 ampoules.
As per SRO.
Approval Status of product in Reference Toradol Injection of Atnahs Pharma, UK (MHRA Approved)
Me-too Status Toralac Injection 30mg/ml by M/s Vision Pharma
(Reg#050290).
Decision: Approved.
Brand Name + Dosage Form + Strength Mevit 500mcg/ml Injection
Mecobalamin…………..500mcg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Vitamin B12
Type of Form Form-5
Finished Product Specification Firm has claimed manufacturer‘s specifications.
Pack Size & Demanded Price 02x05 ampoules, 50 ampoules & 100 ampoules. As per SRO.
Approval Status of product in Reference PMDA approved.
Me-too Status Wycomin 500 mcg Injection by Wnsfeild Pharmaceuticals.
Reg. No. 75581.
Decision: Approved.
Brand Name + Dosage Form + Strength Diqran 75mg/3ml Injection
Diclofenac Sodium………………75mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group NSAID‘s.
Type of Form Form-5
Pack Size & Demanded Price 1x5ampoules, 25 ampoules & 100ampoules.
As per SRO.
Approval Status of product in Reference Voltarol ampoules 75mg/3ml (UK-MHRA).
Me-too Status Defnac 75mg/3ml of M/s Searle Pakistan Pvt. Ltd.
Decision: Approved.
Brand Name + Dosage Form + Strength I-Spa 40mg/2ml Injection
Drotaverine as HCl……………….40mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Anti-spasmodic
Type of Form Form-5
Finished Product Specification Manufacturer‘s Specification
Approval Status of product in Reference 1. NO-SPA 40 mg solution for injection by Sanofi
Regulatory Authorities Aventis (OGYEI Hungary Approved) (Link:
https://www.ogyei.gov.hu/gyogyszeradatbazis/index.php?a
ction=show_details&item=11235)
2. 2. NO-SPA 40 mg / 2 ml solution for injection by
Sanofi
Romania (NAMMD Romania Approved) (Link:
https://www.anm.ro/_/_RCP/RCP_6973_10.10.14.pdf
Me-too Status NO-SPA Injection of M/s Sanofi Aventis Pakistan R.No. 8296.

Brand Name + Dosage Form + Strength Qinimide 20mg/2ml Injection
Furosemide……………….20mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Loop Diuretics
Type of Form Form-5
Pack Size & Demanded Price 2mlx50ampoules. As per SRO.
Approval Status of product in Reference Furosemide 20mg /2ml solution for Injection (MHRA
Regulatory Authorities approved)
Me-too Status Lasix Injection of Sanofi Aventis (Reg#000230)
Brand Name + Dosage Form + Strength RBC-Fer 100mg/5ml Injection
Iron as Iron Sucrose…………….100mg"
Rs.20,000/- Dated 07-03-2019
Pharmacological Group Iron salt
Type of Form Form-5
Pack Size & Demanded Price 1x5 ampoules. As per SRO.
Approval Status of product in Reference Venofer Injection by Vifor (MHRA Approved).
Me-too Status Vortex 100mg/ 5ml injection of Saturn Pharma Reg. No. 71281
Decision: Approved with BP specification and change of brand name.

Brand Name + Dosage Form + Strength Lidolic 10mg/ml injection
Lidocaine Hcl……………………..20mg"
Diary No. Date of R & I & Fee Form-5 Dy.#15589 dated 07-03-2019 Rs.20,000/- 07-03-2019
Pharmacological Group Local anaesthetics
Type of Form Form-5
Pack Size & Demanded Price 01x5ampoules
Approval Status of product in Reference Lidocaine injection 1% w/v of B. Braun (MHRA approved)
Me-too Status Lidocaine HCl 1% Injection of Healthtek (Reg#079939)
Decision: Approved as IM preparation.
Brand Name + Dosage Form + Strength Lidolic 20mg/ml Injection
Lidocaine HCl……………..40mg"
Rs.20,000/- Dated 06-03-2019
Pharmacological Group Local anaesthetics
Type of Form Form-5
Pack Size & Demanded Price 02x5ampoules
Approval Status of product in Reference Approved by MHRA of UK.
Me-too Status Lignox 2% injection (2ml) of M/s Novamed (Reg. #076968).
Decision: Approved as IM preparation.
Case No. 03: Registration Applications for Local Manufacturing of (Veterinary) Drugs.
a. New Cases:-
705. Name and address of manufacturer / M/s Farm Aid Group, plot # 3/2, Phase I & II, Hattar Industrial
Applicant Estate, Haripur.
Brand Name +Dosage Form + Strength Rafticol Liquid
Composition Each 100 ml contains:
Florfenicol………..…..11gm
Colistine Sulphate……….50MIU
Pharmacological Group Quinolone Antibiotic
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 200ml, 250ml, 500ml, 1 Litre, 2.5 litre, 5Liter,
15 Litre, 20 Litre, 25 Litre. Decontrolled.
Me-too status F-COL Liquid by "D-Maarson Pharmaceuticals, Plot # 17,
Street SS-2, National Industrial Zone, Rawat, Islamabad."
Reg. No. 072679.
GMP status Routine GMP inspection was conducted on 03.10.2018 by
Area FID and concluded as under:
The firm is considered to be operating at satisfactory level of
GMP and found to be fulfilling GMP requirements.

706. Name and address of manufacturer / Farm Aid Group, plot # 3/2, Phase I & II, Hattar Industrial
Brand Name +Dosage Form + Strength Tylofag Powder
Composition "Each kg Contains:-
Tylosin Tartrate ……...500gm"
Pharmacological Group Macrolid Antibiotic
Type of Form Form5
Pack size & Demanded Price 10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500gm, 1 kg, 5kg,
10kg, 15kg, 20kg, 25kg.

Me-too status Tylo-50 Water Soluble Powder by M/s Symans
Pharmaceuticals (Pvt) Ltd, Lahore. Reg. No. 63847.
707. Name and address of manufacturer / Farm Aid Group, plot # 3/2, Phase I & II, Hattar Industrial
Brand Name +Dosage Form + Strength Doxy-DS Powder
Composition Doxycycline Hcl………….....400gm
Tylosin Tartrate…………….200gm
Colistin Sulphate……………500MIU
Bromhexine Hcl……………10gm
Type of Form Form 5
Pack size & Demanded Price 10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500gm, 1 kg, 5kg,
10kg, 15kg, 20kg, 25kg.
Me-too status Fit Respi Water Soluble Powder by ―D-Maarson
Pharmaceuticals, Plot # 17, Street SS-2, National Industrial
Zone, Rawat, Islamabad.‖
708. Name and address of manufacturer / MYLAB Pvt. Ltd, Khankah Shariff Bahawalpur
Applicant
Brand Name +Dosage Form + Strength Animec Injection
IVERMECTIN.....................10.5mg.
Pharmacological Group Anthelmintic
Type of Form Form 5
Pack size & Demanded Price Decontrolled

Me-too status I-Mectin injection by M/s International Pharma Labs.,
Raiwind Road Lahore. Reg. No. 63618
GMP status Panel inspection was conducted on 13.09.2018 & 14.09.2018
for the purpose of renewal of DML and grant of additional
section. The panel recommended renewal of DML and grant
of additional sections.

709. Name and address of manufacturer / MYLAB Pvt. Ltd, Khankah Shariff Bahawalpur.
Applicant
Brand Name +Dosage Form + Strength Tiamax Water Soluble Powder
Tiamulin ( as Hydrogen Fumerate)………45gm
Pharmacological Group Broad Spectrum Antibiotic
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1kg, 5kg, 10kg, Decontrolled.
Me-too status Tiamubak 45% Oral Powder by M/s Attabak pharmaceuticals,
Islamabad. Reg. No. 048170
Applicant
Brand Name +Dosage Form + Strength Tilmax Oral Solution
Tilmicosin Phosphate……250mg
Pharmacological Group Macrolid Antibiotic
Type of Form Form 5
Pack size & Demanded Price 240ml, 500ml, 1000ml, 5 Litre, Decontrolled.
Me-too status Biotil Reg. No. 046568 by Bio-Labs (Pvt) Ltd., Islamabad.
Applicant
Brand Name +Dosage Form + Strength Savizol Drench
Oxyclozanide……….22.65mg
Type of Form Form 5

Me-too status Me-too could not be confirmed from available database.
Remarks of the Evaluator Me-too could not be confirmed from available database.
Decision: Deferred for providing evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm.
Applicant
Brand Name +Dosage Form + Strength Albazen Drench
Albendazole………..112.5mg
Type of Form Form 5
Me-too status Valbazen Drench 11.25% of SK & F (Reg. No. 013228)
Applicant
Brand Name +Dosage Form + Strength Fluxin Injection
Flunixin Meglumine…………..50mg
Diary No. Date of R& I &fee Dy. No.832; 05-01-2018; Rs.20,000/- (22-12-2017)
Pharmacological Group Non-steroidal, Analgesic Agent
Type of Form Form 5
Pack size & Demanded Price 10ml Glass vial, 20ml Glass vial, 50ml Glass vial, 100ml
Glass vial.
Me-too status Loxin Injection By M/S Selmore Pharmaceuticals (Pvt) Ltd,
Lahore. Reg. No. 35098
Applicant
Brand Name +Dosage Form + Strength Trobanil R.T.U Injection
Diminzene Aceturate……………50mg
Antipyrine………………………350mg
Pharmacological Group Anti-protozoan; Antipyretic
Type of Form Form 5
Pack size & Demanded Price 10ml Glass vial, 20ml Glass vial, 50ml Glass vial, 100ml
Glass vial.
Me-too status Fa Try Banil R.T.U. Injection by M/s prix Pharma. R.# 27476
Remarks of the Evaluator Me-too status of applied strength could not be verified from
available database. Accordingly firm was asked to clarify.
Firm in response submitted revised strength from 250mg to
350mg as per Me-too along with differential fee of
Rs.5000/dated 08.05.2019 with deposit slip no. 1936659.
Decision: Deferred for deliberation regarding chemical nature of Anti-pyrine.
Applicant
Brand Name +Dosage Form + Strength Colimax Water Soluble Powder
Colistin Sulphate………….50MIU
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1000gm, 5kg
Me-too status Me-too status could not be verified from available database.
Remarks of the Evaluator Submit Me-too reference evidence.
Submit Form-5 undertaking duly signed by concerned person.
Applicant
Brand Name +Dosage Form + Strength Neofarm Water Soluble Powder
Composition Each gram contains:
Neomycin Sulphate ………..700mg
Pharmacological Group Antibiotic, Ant glycoside
Type of Form Form 5
Pack size & Demanded Price 500gm, 1kg, 5kg, 10kg, Decontrolled
Me-too status Neocin Powder by M/s Leads Pharma (Pvt) Ltd., Islamabad.
Reg. No. 063714
Applicant
Brand Name +Dosage Form + Strength Tetragen Water Soluble Powder
Composition Each kg contains:-
Tiamulin hydrogen Fumerate………….124gm
Chlortetracycline Hydrochloride………321.54gm
Pharmacological Group Broad spectrum Antibiotic
Type of Form Form 5
Pack size & Demanded Price 500gm, 1kg, 5kg, 10kg
Me-too status CDC Plus Water Soluble Powder by M/s Alina Combine
Pharmaceuticals (Pvt) Ltd., Karachi Reg. No. 49689
Applicant
Brand Name +Dosage Form + Strength Fighter Drench
Oxyclozanide…………62.5mg
Oxfendazole…………..22.5mg
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, 5 Litre
Me-too status Thunder Drench by Star Laboratories (Pvt) Ltd, Lahore, Reg.
No. 58941
Applicant
Brand Name +Dosage Form + Strength Kilzan Drench
Levamisole……….15mg
Oxyclozanide……..30mg
Type of Form Form 5
Me-too status El-Levaclozanil Suspension by Elko Organization Karachi
Reg. No. 022158
Applicant
Brand Name +Dosage Form + Strength Bromex Oral Solution
Bromhexine HCl………..10mg
Methanol………………..20mg
Type of Form Form 5
Me-too status Baxsel-E solution by M/s Baxter Pharmaceuticals, A-1/A,
Scheme # 3, Phase 1, S.I.T.E., Super Highway, Karachi. Reg.
No. 72636.
Applicant
Brand Name +Dosage Form + Strength Diarin Oral Powder
Composition Each 28gm Contains:-
Neomycin Sulphate……………….0.538gm
Streptomycin Sulphate……………0.676gm
Sulphaguandine…………………...5gm
Phthalyl Sulphathiazole…………...1.5gm

Riboflavin…………………………0.1gm
Nicotinamid……………………….0.5gm
Diary No. Date of R& I & fee Dy. No. 826; 05-01-2018 Rs. 20,000/- (22-12-2017)
Pharmacological Group Combination of Antibiotics & Vitamins
Type of Form Form-5
Pack size & Demanded Price 28gm, 100gm, 500gm, 1kg. Decontrolled.
Me-too status Neodiaristin Oral Powder by M/s Prix Pharmaceuticals,
Lahore Reg. No. 33221
Applicant
Brand Name +Dosage Form + Strength Tamulin 125 Oral Solution
Tiamulin Hydrogen Fumerate…125mg
Diary No. Date of R& I & fee Dy. No 823; 05-01-2018 Rs. 20,000/- (22-12-2017)
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, 5 Litre.
Me-too status Vetamulin-100 Injection. By M/s LabPak International (Pvt)
Ltd., Islamabad Reg. No. 48143
Applicant
Brand Name +Dosage Form + Strength Roxaflox Gold Oral Soution
Enrofloxacin Base…200mg
Type of Form Form 5
Me-too status Vety-Enrox Liquid by Vety-Care Islamabad Reg. No. 19940
Applicant
Brand Name +Dosage Form + Strength Mineral Injection
Composition Each ml Contains:-
Sodium as Iodide…………………………...50mg
Potassium as Iodide.......................................50mg
Potassium as Chloride....................................4.28mg
Zinc as Chloride.............................................0.135mg
Manganese as Chloride...................................0.885mg
Magnesium as Chloride..................................19.64mg
Copper as Chloride.........................................0.220mg
Ferrous as Chloride........................................12.960mg
Molybdenum as Ammonium Molybdate........0.018mg
Cobalt as Chloride..........................................0.164mg
Calcium as Gluconate.....................................300mg
Pharmacological Group Mineral Supplements
Type of Form Form 5
Pack size & Demanded Price 10ml Glass Vial, 20ml Glass Vial, 30ml Glass Vial, 50ml
Glass Vial, 100ml Glass Vial. Decontrolled.
Me-too status Minerasol Injection by Selmore Pharmaceuticals (Pvt) ltd.,
Lahore Reg. No. 29664.
Applicant
Brand Name +Dosage Form + Strength CRC 25 % Water Soluble Powder
Composition Each Gram Contains:-
Chlortetracycline as HCl…………….. 250mg.
Type of Form Form 5
Pack size & Demanded Price 500gm, 1kg, 5kg, 10kg, Decontrolled.
Me-too status Chlortetravet Water Soluble Powder by M/s Samara Stores,
Hyderabad Reg. No. 28567
Applicant
Brand Name +Dosage Form + Strength Micospec Injection
Spectinomycin as HCL…………100mg
Lincomycin HCL………………..50mg
Type of Form Form 5
Pack size & Demanded Price 10ml Glass Vial, 20ml Glass Vial, 50ml Glass Vial, 100ml
Glass Vial. Decontrolled.
Me-too status Lincopec Injection by M/s Leads Pharma. Reg. No. 043581
Decision: Approved with Innovator‘s specifications. Firm shall select 01 fill volume of the product.

Applicant
Brand Name +Dosage Form + Strength Hydromycin Water Soluble Powder
Composition Each kg Contains:
Lincomycin as HCL…………….400gm
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1000gm, 5kg, 10kg, 20kg. Decontrolled.
Me-too status Lincocin 40% Soluble Powder by M/s Pharmacia Pakistan Pvt.
Ltd., Islamabad Reg. No. 29685
Applicant
Brand Name +Dosage Form + Strength Duralin Complex Injection
Oxytetracycline HCL………………………10mg
Dexamethasone as Sodium Phosphate……..0.5mg
Diary No. Date of R& I & fee Dy. No 13038, dated 06-04-2018
Rs.20,000/- Dated 27-02-2018
Pharmacological Group Anti-Inflammatory-Anti biotic combination
Type of Form Form 5
Pack size & Demanded Price 10 ml Clear Glass vial,
20 ml Clear Glass vial,
Decontrolled.
Me-too status OXY COMPLEX INJECTION 150MG
Remarks of the Evaluator The Firm was asked to clarify Me-too and formulation, firm in
reply submitted revised formulation from 100mg to 10mg as
per Me-toowithout submission of fee.
Decision: Deferred for submission of differential fee for revised formulation i.e. Rs.5000/=.
Applicant
Brand Name +Dosage Form + Strength Rapidox Water Soluble Powder
Doxycycline Hyclate………..400gm
Tylosin Tartrate……………..200gm
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1kg, 5kg, 10kg, 25kg. Decontrolled.
Me-too status Bax Tylo 60 Powder by M/s "Baxter Pharmaceuticals, Super
Highway, Karachi Reg. No. 72640
Applicant
Brand Name +Dosage Form + Strength Hi-Renyl Powder
Composition Each 100gm Contains:
Ammonium Chloride………45gm
Magnesium Sulphate………25gm
Sodium Sulphate…………...25gm
Sorbitol……………………..5gm
Rs.20,000/- Dated 27-02-2018
Pharmacological Group Nutritional Supplement ( Dietary electrolyte balance)
Type of Form Form 5
Pack size & Demanded Price 1kg, 5kg, 10kg, 20kg, 25kg. Decontrolled.
Me-too status Renal Plus Powder by M/s Bio-Labs Pvt. Ltd, Reg. No. 43173.
Applicant
Brand Name +Dosage Form + Strength Vitamax K3 Water Soluble Powder
Vitamin K3……………..40gm
Diary No. Date of R& I &fee Dy. No 13035 dated 06-04-2018 Rs.20,000/- 27-02-2018
Pharmacological Group Vitamin Supplements
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1kg, 5kg, 10kg, 20kg. Decontrolled.
Me-too status Me too status could not be verified from the available
database.
Remarks of the Evaluator Me-too could not be verified from available database.
Applied product is Vitamin K3 Powder and Attached deposit
slip is for Spasmin Injection.
 Deposit slip clarification.
Applicant
Brand Name +Dosage Form + Strength Curbex Powder
Calcium Propionate……….44.5%
Sorbic Acid………………..4%
Fumaric Acid………………4%

Rs.20,000/- Dated 27-02-2018
Pharmacological Group Calcium supplement
Type of Form Form 5
Me-too status Myco Curb Dry Powder by M/s Vet Pharma Trading
Gujranwala Reg. No. 20145
Applicant
Brand Name +Dosage Form + Strength Salimax 120 Premix
Salinomycin Sodium………120gm
Rs.20,000/- Dated 27-02-2018
Type of Form Form 5
Me-too status Salinomix Water Soluble Powder 6% by M/s Rex
Pharmaceutical Pakistan, Karachi.
Decision: Approved with Brand name ―Salimax 120‖and Innovator‘s specifications.
Applicant
Brand Name +Dosage Form + Strength Lipodol Powder
Composition Each Kg Contains:
Clopidol……………..98%"
Diary No. Date of R& I &fee Dy. No 13030 dated 06-04-2018
Rs.20,000/- Dated 27-02-2018
Pharmacological Group Antiprotozoal
Type of Form Form 5

Me-too status Clopidol Powder By M/S Vetimpex Trading Co Karachi Reg.
No. 14516
Applicant
Brand Name +Dosage Form + Strength Mycoban 200 Premix
Monensin Sodium…………..200gm
Rs.20,000/- Dated 27-02-2018
Pharmacological Group Broad spectrum Antibiotic
Type of Form Form 5
Me-too status Elancoban 200 premix by M/s Eli Lilly Fegersheim Exp by Eli
Lilly Switzerland Reg. No. 013729.
Decision: Approved with the Brand name ―Mycoban 200‖ and Innovator‘s specifications.
Applicant
Brand Name +Dosage Form + Strength Grafix Plus Powder
Inactivated Yeast………………..31%
Diatomaceous Earth……………..55.2%
Zeolite…………………………...13%
Rs.20,000/- Dated 27-02-2018
Pharmacological Group Saccharomyces cerevisiae
Type of Form Form 5

Me-too status Mycofix Plus by M/s Naseem Vet Rawalpindi. Reg. No.
19910
Decision: Registration Board decided to seek comments of H&OTC Division about formulation.
Applicant
Brand Name +Dosage Form + Strength Vita-3 Injection
Vitamin A Palmitate……………80,000 IU
Vitamin E Acetate……………...20mg
Vitamin D3…………………….40,000 IU
Rs.20,000/- Dated 27-02-2018
Pharmacological Group
Type of Form Form 5
Pack size & Demanded Price 10 ml Clear Glass vial,
Decontrolled.
Me-too status Vitamin AD3E Injection by M/s Prix Pharma Reg. No. 22175
th
Decision: Approved with Innovator‘s specifications. Firm shall select 1 fill volume of the product.
Case No. 04: Registration Applications of Newly Granted DML or New Section
(Veterinary)
a. New Section ( New Cases)
Oral Powder Section
10 Molecules/ 22 Products.
738. Name and address of manufacturer M/s Vetec Laboratories, Plot No. 20, Street S-5, National
/Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength ANTHEY PLUS POWDER
Composition Each 1000 gm Contains:-
Levamisole HCL……………750 gm
Diary No. Date of R & I & Fee Dy. No. 11632; 06-03-2019; Rs. 20,000/- (01-03-2019)
Type of Form Form-5
Finished Product Specification Firm has claimed In-house specification
Pack Size & Demanded Price 100gm, 500gm, 1Kg, 2.5 kg, 5 kg, 25 kg : Decontrolled
Approval Status of product in Reference N/A
Me-too Status Levoral 75% by N.B Sons (Pvt) Ltd., Lahore. (Reg. No. 049588)
GMP Status New License (Inspection Date: 04-10-2018 & 05-11-2018).
DML issued on 05.03.19
739. Name and address of manufacturer M/s Vetec Laboratories, Plot No. 20, Street S-5, National
/Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength BROMODOX-60 POWDER
Composition Each 100 gm Contains :-
Tylosin Tartrate……………….20 gm
Doxycycline Hyclate………….40 gm
Colistin Sulphate………….......10 gm
Bromhexine HCL……………..2 gm
Type of Form Form-5
Me-too Status BROCOTYD by Univet Pharmaceuticals (Reg. No. 058962).
Remarks of the Evaluator Firm was asked to correct salt from Doxycycline HCL to
Doxycycline Hyclate along with the submission of applicable
fee.
Firm in response submitted revised Form5 with correct label
claim but did not submit the fee for revision of formulation.
Decision:Deferred for submission of fee for revision of formulation.
740. Name and address of manufacturer / M/s Vetec Laboratories, Plot No. 20, Street S-5, National
Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength PARA-COOL POWDER
Paracetamol……………..20 gm

Vitamin C………………..5 gm
Potassium Carbonate…….12.5 gm
Sodium Bicarbonate……..12.5 gm
Vitamin E………………..1.25 gm
Type of Form Form-5
Me-too Status PARACE by Biogen Pharmaceuticals (Reg. No. 063812)
Remarks of the Evaluator Firm was asked to correct API Strength in Master formulation as
per Me-too or justify the formulation.
Firm in reply submitted same formulation which is not as per
Me-too.
me-too status) alongwith registration number, brand name and name of firm.
Brand Name + Dosage Form + Strength LINCO FORTE-V POWDER
Lincomycin HCL……110 gm
Diary No. Date of R & I & Fee Dy No. 11649; 06-03-2019; Rs. 20,000/- (01-03-2019)
Type of Form Form-5
Me-too Status Lincowan Forte by Nawan Labs Karachi. (Reg. No. 022149).
Brand Name + Dosage Form + Strength ANTA 10 POWDER
Amantadine HCL……10 gm
Pharmacological Group Antibiotic/ Antibacterial
Type of Form Form-5
Me-too Status ACEDINE by Leads Pharmaceuticals (Reg. No. 078356)

Brand Name + Dosage Form + Strength SE-DOX 50 POWDER
Doxycycline HCL…………………500 gm
Type of Form Form-5
Me-too Status Me-too could not be verified from available data base.
Remarks of the Evaluator Firm was asked to submit Me-too or correct salt from
Doxycycline HCL to Doxycycline Hyclate as per available Me-
too along with the submission of applicable fee.
Firm in response submitted me-too which is Doxycycline
Hyclate of M/s Selmore.
Brand Name + Dosage Form + Strength SE- LINCO POWDER
Lincomycin HCL…………..44 gm
Type of Form Form-5
Me-too Status Lincomix Powder by Pfizer Animal Health (Reg. No. 017935).
Brand Name + Dosage Form + Strength D-TYLOXINE 20 POWDER
Tylosin Tartrate……200 gm
Doxycycline Hyclate……400 gm
Colistin Sulphate……..1000 M.I.U
Bromhexine HCL……10 gm
Diary No. Date of R & I & Fee Dy. No. 11629; 06-03-2019; Rs. 20,000/- (01.03-2019)
Type of Form Form-5
Me-too Status MAKZIM PLUS by Evergreen Pharmaceuticals Reg.No.
Remarks of the Evaluator Firm was asked to correct salt from Doxycycline HCL to
Doxycycline Hyclate along with the submission of applicable
fee.
Firm in response submitted revised Form5 with correct label
claim but did not submit the fee for revision of formulation.
Applicant Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength BROMODOX-30 POWDER
Tylosin Tartrate………100 gm
Doxycycline HCL……200 gm
Colistin Sulphate……..400 M.I.U
Bromhexine HCL……3 gm
Type of Form Form-5
Me-too Status BROMODOX-T by Attabak Pharmaceuticals (Reg.No. 049788).
Brand Name + Dosage Form + Strength OXINOTIN-V POWDER
Oxytetracycline HCL………….200 gm
Neomycin Sulphate……………200 gm
Colistin Sulphate……….. …….240 M.I.U
Type of Form Form-5
Me-too Status OXCINOCOL by Elegance Pharmaceuticals (Reg. No. 034533)
Brand Name + Dosage Form + Strength LINCOMAX POWDER
Composition Each gm Contains :-
Lincomycin as HCL……400 mg
Type of Form Form-5
Me-too Status LINCOSEL 40 by Selmore Pharmaceuticals (Reg No. 089826)
Brand Name + Dosage Form + Strength FLORO –FORTE
Composition Each gm Contains:-
Neomycin Sulphate…………………..150 mg
Florfenicol……………………………100 mg
Oxytetracycline HCL…………………300 mg
Type of Form Form-5
Me-too Status E-COL by Evergreen Pharmaceuticals (Reg. No. 081733)
Remarks of the Evaluator Firm was asked to Revise Oxytetracycline to Oxytetracycline
HCL in label claim and Master Formula as per Me-too along
with the submission of applicable fee.
Firm submitted revised form5 with correct label claim and fee of
Rs.5000/ deposit slip No. 0828982 dated 08/05/2019.
Brand Name + Dosage Form + Strength SE REST POWDER
Tylosin Tartarate……………..200 gm
Doxycycline HCL…………….400 gm
Colistin Sulphate……………...500 M.I.U
Bromhexine HCL……………..10 gm
Pharmacological Group Antibiotic/ Expectorant
Type of Form Form-5
Me-too Status DOX 40 by Nawal Pharmaceuticals (Reg. No. 074096).
Brand Name + Dosage Form + Strength COLIDOXIL –DS POWDER

Tylosin Tartrate……………20 gm
Doxycycline HCL…………40 gm
Colistin Sulphate………….6 gm
Bromhexine HCL…………2 gm
Type of Form Form-5
Me-too Status NOBI TDC 680 by Noble Pharmaceuticals (Reg. No. 062127).
Brand Name + Dosage Form + Strength BLSS 4 POWDER
Lincomycin HCL…………….5 gm
Spectinomycin HCL…………7.5 gm
Spiramycin Adipose…………2.5 gm
Bromhexine HCL……………0.5 gm
Type of Form Form-5
Me-too Status SPECLINX by Ventage Pharmaceuticals ( Reg. No. 081714)
DML issued on 05.03.19.
Remarks of the Evaluator Firm was asked to revise Spiramycin Adipate to Spiramycin
Adipose and Bromhexine to Bromhexine HCL along with the
submission of applicable fee.
Firm in reply submitted updated form5 with correct label claim
and fee of Rs.5000/ with deposit slip No. 0828983 dated
08.05.2019.
Brand Name + Dosage Form + Strength NEOXYCOLIN POWDER
Oxytetracycline HCL…………250 gm
Neomycin Sulphate…………..250 gm
Colistin Sulphate……….. …..300 M.I.U
Type of Form Form-5
Me-too Status OXYCOL FORTE by Attabak Pharmaceuticals (Reg.# 071068)
Brand Name + Dosage Form + Strength DOXYCOL-T POWDER
Tylosin Tartrate……………..10 gm
Doxycycline HCL…………..20 gm
Colistin Sulphate……………3 gm
Bromhexine HCL…………...1 gm
Type of Form Form-5
Me-too Status BIOSIN TD by Leads Pharma (Reg. No. 044951)
Remarks of the Evaluator Firm mentioned different strength on label claim and Master
Formula, Firm was asked to Clarify/Justify.
Firm in reply submitted revised form 5 but which is not as per
Me-too.
Brand Name + Dosage Form + Strength U-DOX-25 POWDER
Doxycycline Hyclate Eq. to Doxycycline Base………25 gm
Type of Form Form-5
Me-too Status UNIDOX-25% by Univet Pharmaceuticals (Reg. No. 029642).
Remarks of the Evaluator Firm was asked to revise Doxycycline to ―Doxycycline Hyclate
eq.to 25gm Doxycycline Base‖ in label claim and Master
Formula along with the submission of applicable fee.
Firm in reply submitted updated Form5 with fee of Rs.5000/
with deposit slip No. 0828984 dated 08.05.2019.
Decision: Approved with Innovator‘s specification.
Brand Name + Dosage Form + Strength PARAZOL POWDER
Paracetamol………………..20 gm
Vitamin C………………….5 gm

Potassium Carbonate………12.5 gm
Sodium Bicarbonate……….12.5 gm
Vitamin E………………….1.25 gm
Type of Form Form-5
Me-too Status POZADOL by Leads Pharmaceuticals (Reg. No. 084969)
Brand Name + Dosage Form + Strength AMANTEX-98% POWDER
Amantadine HCL……98 gm
Pharmacological Group Anti Parkinsons
Type of Form Form-5
Me-too Status Emanta-98 by Evergreen Pharmaceuticals (Reg. No. 081735).
Brand Name + Dosage Form + Strength NCO-FORTE POWDER
Oxytetracycline HCL……..300 gm
Neomycin Sulphate……….250 gm
Colistin Sulphate……….. ..500 M.I.U
Type of Form Form-5
Me-too Status OXYNEORIQ-C by Baariq Pharmaceuticals (Reg. No. 073952).
Remarks of the Evaluator Firm was asked to mention correct label claim form
―Oxytetracycline‖ to ―Oxytetracycline HCL‖ on form 5 with
updated form5 and applicable fee.
The firm in reply submitted updated form5 with correct label
claim and fee of Rs.5000/ with deposit slip No. 0828985 dated
08.05.2019.
Decision:Approved with Innovator‘s specification.
Brand Name + Dosage Form + Strength ST-S3 POWDER
Sulphachlorpyrazine Sodium as (Sulphachlozine Sodium Salt
Monohydrate)….. ………….30 gm
Type of Form Form-5
Me-too Status SB-S3 by SB Pharmaceuticals (Reg. No. 028538)
Remarks of the Evaluator Firm was asked to correct label claim and add salt with API
along with submission of applicable fee and updated Form5.
Firm in reply submitted revised form5 with correct label claim
and fee of Rs.5000/ with deposit slip No.0828986 Dated
08.05.2019.
Evaluator PEC-IV
Case no. 01: Registration Applications for Local Manufacturing of (Human) Drugs.
a. New Cases.
760. Name and address of manufacturer / Hamaz Pharmaceuticals (pvt) Ltd, 13 KM Bosan Road, Multan
Applicant
Brand Name +Dosage Form + Strength Nefox Tablet 100mg
Composition Each tablet contains:-
Nimesulide………..100mg
Diary No. Date of R& I & fee Dy.No 348 dated 03.03.2015 Rs.8000/- 06-07-10
Rs.12000/= 02.03.2015
Pharmacological Group NSAID Cox-2 Inhibitor
Type of Form Form 5
Pack size & Demanded Price 20‘s; Rs. 100/
Approval status of product in Approved by EMA
Me-too status (with strength and Nimside Tablets 100mg.of M/s Novamed
dosage form) Pharmaceuticals
GMP status Last GMP inspection conducted on 17-01-2018., and the report
concludes that the firm was considered to be operating at
satisfactory level of compliance to the cGMP
Decision: Keeping in view the approval status of Nimesulide 100mg tablet in EMA, the Registration
Board approved the applied formulation of Nimesulide Tablets 100mg with innovator‘s specifications
and a pack size of 15 tablets as per recommendations of EMA only for the following clinical
indications as a second line choice.
 Treatment of acute pain
 Primary dysmenorrhea
761. Name and address of manufacturer / Hamaz Pharmaceuticals (pvt) Ltd, 13 KM Bosan Road, Multan
Applicant
Brand Name +Dosage Form + Strength Rockcef Suspension 250mg

Cephradine USP….250mg
Diary No. Date of R& I & fee Dy.No 356 dated 03.03.2015. Rs.8000/- 05-07-10
Rs.12000/= 02.03.2015
Type of Form Form 5
Finished product Specifications USP Specs
Pack size & Demanded Price 60ml bottle; Rs 128/pack
Approval status of product in Velocef of USFDA discontinued
Me-too status (with strength and Cephrascot suspension by M/s Scotmann
Decision: Approved as suspension based upon approval status in USFDA and available metoo.
762. Name and address of manufacturer / M/s Epharm Laboratories. A-40, Road No. 1, S.I.T.E. Super
Applicant Highway Industrial Area, North Karachi
Brand Name +Dosage Form + Strength Tamsin-0.4mg SR Capsule
Tamsulosin HCL SR pellets 0.2% w/w eq. to Tamsulosin
HCL…….…0.4mg
Diary No. Date of R& I & fee Dy.No;25214 19-12-2017 Rs. 20,000-(18-12-2017)
Pharmacological Group Alpha blocker
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s ; As per SRO
Approval status of product in Contiflo xl capsule of (MHRA approved)
Me-too status (with strength and Alfamax tablet M/s Platinum Pharmaceuticals,
dosage form)
GMP status The last GMP inspection conducted on 01-03-2018 & report
concludes that current level of compliance was noted as
satisfactory.
Remarks of the Evaluator4  Source of pellets : Vision Pharmaceuticals
763. Name and address of manufacturer / M/s Noa Hemis Pharmaceuticals. Plot No. 154, Sector-23,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Eslor 5mg Tablet
Desloratadine…5mg
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s ; As per PRC
Approval status of product in CLARINEX of USFDA approved
Me-too status Larinex Tablets of M/s Getz Pharma
GMP status Last GMP inspection conducted on 20-03-2018., and the report
concludes that the firm was considered to be operating at an
acceptable level of compliance to the cGMP
Decision: Approved
Brand Name +Dosage Form + Strength Alpha Keto Tablets

Alpha-Keto phenyl alanine,Ca Salt……….68mg
Alpha-Hydroxymethionine,Ca Salt………59mg
Alpha-Keto isoleucine,Ca Salt…..…67mg
Alpha-Keto leucine,Ca Salt……..101mg
Alpha-Keto valine,Ca Salt………86mg
L-Tryptophan………23mg
L-Threonine……….53mg
L-Tyrosine…………30mg
L-Histidine……...38mg
L-Lysine...........105mg
Pharmacological Group Amino-Acids
Type of Form Form 5
Finished product Specifications Manufacturer‘s Specifications
Approval status of product in KETOSTERIL by Fresenius Kabi, Germany.(Bfarm
Reference Regulatory Authorities approved)
Me-too status (with strength and Ketoalfa Tablets M/s Genome Pharmaceuticals
dosage form)
4
765. Name and address of manufacturer / M/s Noa Hemis Pharmaceuticals, Plot No. 154, Sector-23,
Brand Name +Dosage Form + Strength Fibrogel-M Sachet
Ispaghula husk…3.5gm
Mebeverine HCl…135mg
Pharmacological Group Anti-Spasmodic
Type of Form Form 5
Approval status of product in Fybogel Mebeverine effervescent granules by M/s Reckitt
Reference Regulatory Authorities Benckiser Healthcare (UK) Ltd. (MHRA approved)
Me-too status (with strength and Colospas Fibro 135mg/3.5g powder by M/s Nabiqasim.
dosage form) (Reg#058672)
Brand Name +Dosage Form + Strength Panzet 40mg Tablet
Composition Each Gastro Resistant Tablet contains:
Pantoprazole (as Sodium Sesquihydrate)…40mg
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s, , ; As per PRC
Approval status of product in Pantoprazole 40 mg Tablet Of ( MHRA Approved)
Me-too status (with strength and Pantopraz 40mg Tablet M/s Klifton Pharma,
dosage form)
Decision: Approved
Brand Name +Dosage Form + Strength Snapta 50mg Tablet
Sertraline (as HCl)…50mg
Pharmacological Group Anti depressant
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s ; As per PRC
Approval status of product in Zoloft Tablet Of (USFDA Approved)
Me-too status (with strength and Ertalin 50 mg Tablets M/s Genome Pharmaceuticals
dosage form)
Decision: Approved
Brand Name +Dosage Form + Strength Lastine 10mg Tablet
Ebastine…10mg
Type of Form Form 5
Approval status of product in EBASTINE ARROW 10 mg film-coated tablets
Reference Regulatory Authorities ANSM Approved
Me-too status (with strength and Atmos Tablets 10mg of M/s Scotmann Pharmaceuticals
dosage form)
Brand Name +Dosage Form + Strength Noatrin-D 20mg Tablet
Composition Each Dipersible tablet contains:
Piroxicam (as Betacyclodextrin)…20mg
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s ; As per SRO
Approval status of product in Not found
Me-too status (with strength and Infladex Dispersible Tablets of M/s Gray's
Remarks of the Evaluator4  Evidence of approval of applied formulation in reference
 (Only piroxicam in reference product)

authorities/agencies which were declared/approved by the Registration Board in its 275 th meeting.
770. Name and address of manufacturer / M/s Brookes Pharma Pvt Ltd. 58 & 59, Sector 15, Korangi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Claron 125mg/5ml Suspension
Clarithromycin as taste masked granules 38%…125mg
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form-5
Pack size & Demanded Price 60ml ;As per SRO
Approval status of product in Biaxin granules for oral suspension 125mg/5ml by M/s
Reference Regulatory Authorities Abbvie, USFDA approved.
Me-too status (with strength and Rethro 125mg/5ml Dry Suspension by M/s Regal
dosage form) Pharmaceuticals.
GMP status Last GMP inspection conducted 29-11-2018
and the report concludes that firm was considered
to be operating at Satisfactory level of compliance
with GMPguidelines
Remarks of the Evaluator4  Source of pellets; Surge Laboratories
 (22-02-2018 GMP certificate)
Decision: Approved
771. Name and address of manufacturer / M/S Welwrd Pharmaceuticals, Plot No ; 3, Block A, Phase I – II,
Applicant Industrial Estat,Hattar, Pakistan
Contract manufactured by
M/S Wnsfeild Pharmaceuticals, Hattar Pakistan.
Brand Name +Dosage Form + Strength Welgest 10mg tablet
Composition Each film tablet contains:
Dydrogesterone..…………10mg
Diary No. Date of R& I & fee Dy.No.10556; 31-07-2017; Rs.50,000/- (31-07-2017)
Pharmacological Group Progesterone
Type of Form Form 5
Pack size & Demanded Price 20‘s ; As per SRO
Approval status of product in
Reference Regulatory Authorities Duphaston by BGP Products (Swissmedic Approved)
Me-too status (with strength and Duphaston by Abbott (Reg. No. 006654)
dosage form)
GMP status Last GMP inspection of Welwrd conducted on 12-11-2018 and
the report concludes that firm is operating at satisfactory level
GMP
&
Last GMP inspection of Wnsfeild conducted on 18-01-2018 and
the report concludes renewal of DML
Remarks of the Evaluator  Contract manufacturing agreement: Attached
 Number of sections of applicant approved by Licensing
Board:08
 Number of products already registered/approved on
contract manufacturing in the name of applicant: 02
Decision: Approved

B. DEFERRED CASES:
772. Name and address of manufacturer / M/s Dr Raza Pharma, B-4, Plot No. 44- C, Industrial Estate,
Brand Name +Dosage Form + Strength Lipidase 10mg Tablets
Atorvastatin (as calcium trihydrate salt)……10mg
Diary No. Date of R& I & fee Dy.No :Duplicte 8-3-2011 Rs.8000/- Rs.12000/-
Dated 14-1-2015
Pharmacological Group Hypolipidamic(Statin)
Type of Form Form 5
Finished product Specifications Manufacturer spec
Pack size & Demanded Price 10‘s; 20‘s; 30‘s As Per SRO
Approval status of product in Lipitor tablets by Pfizer (MHRA Approved)
Me-too status (with strength and Lipitor of M/s Pfizer
dosage form)
GMP status Last inspection conducted on 06-08-2018 and report concludes
that overall the cGMP compliance is saisfactory.
Previous remarks of the Evaluator.
Previous decision(s) Deferred for following reasons:
Deferred for updated status of GMP of the firm form QA & LT
division as inspection report submitted by firm does not conclude
GMP compliant status. (M-285)
Evaluation by PEC Last inspection conducted on 24-01-2019 and report concludes
that overall the cGMP compliance is satisfactory.
Decision: Approved with innovator‘s specification. Fee shall be verified as per procedure adopted by
Registration Board.
Brand Name +Dosage Form + Strength DS-100 SR Capsules
Composition Each capsule contains:-
Diclofenac Sodium Pellets equivalent to Diclofenac....100mg
Dated 14-1-2015
Type of Form Form 5
Finished product Specifications USP Specs
Pack size & Demanded Price 10‘s; 20‘s; 30‘s As Per SRO
Approval status of product in Diclofenac Sodium of USFDA approved
Me-too status (with strength and Dicast S.R Tablets of M/s Winbrain Research
dosage form) Laboratories
Previous remarks of the Evaluator. Source of pellets: Vision pharma
GMP compliant status.(M-285)
Registration Board.
Brand Name +Dosage Form + Strength Trizol Suspension
Sulphamethoxazole…..200mg
Trimethoprim……….40mg
Dated 14-1-2015
Pharmacological Group Sulphonamide
Type of Form Form 5
Pack size & Demanded Price 50ml; As Per SRO
Approval status of product in Co-Trimoxazole of MHRA approved
Me-too status (with strength and Cotazole Suspension of M/s Meditech Pharmaceuticals
dosage form)
GMP compliant status.(M-285)
Registration Board.
775. Name and address of manufacturer / CSH Pharamaceuticals (Pvt) Ltd., 32-Km, Ferozepur road,
Applicant Lahore
Brand Name +Dosage Form + Strength Clavicin 375mg Dispersible Tablets
Composition Each dispersible tablet contains:-
Amoxicillin Trihydrate………250mg
Clavulanic Acid…..125mg
Diary No. Date of R& I & fee Dy.No : 590 (Duplicate) 25-02-2013
Pharmacological Group Beta – lactamase inhibitor, Broad spectrum penicillin
Type of Form Form 5
Pack size & Demanded Price 1x6‘s; Rs :300/ 1x 6‘s
Approval status of product in Not found
Me-too status (with strength and Amclav 375mg Tablet of M/s Getz
dosage form)
GMP status Last GMP inspection was conducted on 27-09-2017 and report
concludes that panel recommend the renewal of DML
Previous remarks of the Evaluator.  Evidence of approval of applied formulation in reference
regulatory authorities/ agencies which were declared/
Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies which were declared/
approved by the Registration Board in its 275th meeting (M-282)
Evaluation by PEC Augmentin dispersible tablets 250mg/125mg by EMA approved
Registration Board.
776. Name and address of manufacturer / M/S Lisko Pakistan (Pvt) Ltd. L-10-D Block-21 Shaheed
Applicant Rashid Minhas Road, F.B. Industrial Area, Karachi
Brand Name +Dosage Form + Strength Claricure SR 500mg Tablet
Clarithromycine……….500 mg
Diary No. Date of R& I & fee Dy.No.9792`; 24-07-2017; Rs.20,000/- (14-07-2017)

Type of Form Form 5
Pack size & Demanded Price 1 x 10‘s ; As per SRO
Approval status of product in Klaricid of (MHRA approved)
Me-too status Respect tablet M/s Spencer Pharmaceutical
GMP status Last GMP inspection is conducted on 24- 04- 2018 and the report
concludes that overall firm has satisfactory level of GMP
compliance.
Registration Board directed the firm to submit clarification
regarding applied dosage form whether sustained release or
otherwise (M-283)
Evaluation by PEC Firm reply that Claricure SR 500mg is sustained release product
Decision: Approved.
777. Name and address of manufacturer / Prays Pharmaceuticals, Plot # , Street SS, National Industrial
Applicant Zone (RCCI) Rawat, Islamabad
Manufactured by: Bio Labs (Pvt) Ltd, Plot#, Industrial Triangle,
Kahuta Road Islamabad
Brand Name+Dosage Form + Strength Sun-D Injection
Composition Each ml contain:
Cholecalciferol.......5mg (eq. To 200,000 IU)
Diary No. Date of R& I & fee Dy.No:707 ; 02-02-2015; Rs.250,000/-
Type of Form Form 5
Finished product Specifications (BP Spec‘s)
Pack size & Demanded Price 5ml x 10‘s As per PRC
Approval status of product in Vitamin D3 Good 200,000 IU / 1 ml IM solution for
Reference Regulatory Authorities injection of ( ANSM France approved)
Me-too status (with strength and Calciferol Injection M/s Global Pharmaceuticals
dosage form)
GMP status
Previous remarks of the Evaluator. 
1st Letter: 09th March , 2018

Reminder Letter: 24th April , 2018

Latest GMP inspection report (which should have been
conducted within the period of last one year).
 Contract agreement.
 No. of already registered contract manufactured products.
 Revise Form -5 by applicant (Prays pharma)
Registration Board deferred the case for further deliberation
(M-284)
Evaluation by PEC  No. of already registered contract manufactured products: No
 Revise Form -5 by applicant (Prays pharma): Submitted
Applicant Zone (RCCI) Rawat, Islamabad Manufactured by: (Previous)
Bio Labs (Pvt) Ltd, Plot #, Industrial Triangle, Kahuta Road
Islamabad.
(Now) Nicholas Pharmaceuticals, Plot # 34 St # SS-02 National
Industrial Zone Rawat Islamabad Pakistan.
Brand Name+Dosage Form + Strength Prayxone Injection 250mg IV
Composition Each vial contain:
Ceftriaxone Sodium Eq. To Ceftriaxone......250mg
Diary No. Date of R& I & fee Dy. No. 709; 02-02-2015 ; Rs. 50,000/-
Type of Form Form 5
Approval status of product in Rocephin I.V injection of (MHRA approved)
Me-too status (with strength and Wincef 250 mg IV Injection M/s Wel Wink
dosage form) Pharmaceuticals,
GMP status
Previous remarks of the Evaluator.  Letter: 24th April , 2018
 Latest GMP inspection report (which should have been
 Original contract agreement.
 No. of already registred contract manufactured products
 Revise Form -5 by applicant (Prays pharma).
 Seprate dossier should be submitted for Ceftriaxon I.V
and I.M as separate registeration is granted to these 2
routes. So clarification is required for which routes of
administration you want to apply this dossier along wih
its diluent.
Registration Board deferred the case for further
deliberation (M-284)
 Firm change manufacturing facility from Biolabs to Nicholas
Pharmaceuticals
 Applied for IV route
 Last inspection of Nicholas Pharmaceuticals is conducted on
03- 08- 2018 and the report concludes that
―Keeping in view the above facts, detailed visit of facility and
supporting documents provided by the company, the panel
unanimously recommend the M/s Nicholas for the grant of DML
and sections:
1- Capsule(Cephalosporin)
2- Dry suspension section(Cephalosporin)
3- Dry powder Injectable section(Cephalosporin)
4- Dry powder Injectable section(Carbapenems)‖
Decision: Approved
Islamabad.
Brand Name +Dosage Form + Strength Prayxone Injection 500mg IV
Ceftriaxone Sodium Eq. To Ceftriaxone......500mg
Diary No. Date of R& I & fee Dy. No. 708; 02-02-2015; Rs. 50,000/-
Type of Form Form 5
Me-too status (with strength and Wincef 500 mg IV Injection M/s Wel Wink
dosage form) Pharmaceuticals,
GMP status
its diluent.
 Firm change manufacturing facility from Biolabs to Nicholas
Pharmaceuticals
 Last inspection of Nicholas Pharmaceuticals is conducted on
03- 08- 2018 and the report concludes that
―Keeping in view the above facts, detailed visit of facility
and supporting documents provided by the company, the
panel unanimously recommend the M/s Nicholas for the
grant of DML and sections:
Decision: Approved
Islamabad.
Brand Name +Dosage Form + Strength Prayxone Injection 1gm IV
Ceftriaxone Sodium Eq. To Ceftriaxone......1gm
Diary No. Date of R& I & fee Dy. No. 710; 02-02-2015 ; Rs. 50,000/-
Type of Form Form 5
Me-too status (with strength and Trivolive 1gm Injection I.V M/s Olive Pharmaceuticals
dosage form)
GMP status

its diluent.
Evaluation by PEC  No. of already registered contract manufactured products:
No
 Firm change manufacturing facility from Biolabs to
Nicholas Pharmaceuticals
 Last inspection of Nicholas Pharmaceuticals is
conducted on 03- 08- 2018 and the report concludes that
―Keeping in view the above facts, detailed visit of facility
and supporting documents provided by the company, the
panel unanimously recommend the M/s Nicholas for the
grant of DML and sections:
Decision: Approved
781. Name and address of manufacturer / M/S Welmark Pharmaceuticals, Plot No ; 122, Block B, Phase-
Applicant V, Industrial Estat,Hattar, Pakistan
Brand Name +Dosage Form + Strength Weltop 25mg Tablet
Topiramate……….25mg
Pharmacological Group Antiepileptic agent
Type of Form Form 5
Approval status of product in Topamax Of ( USFDA Approved)
Me-too status (with strength and Lowseiz 25mg Tablets of M/S Helix Pharma
dosage form)
GMP status Last GMP inspection was conducted on 16-09-2017 and
the report concludes that overall firm was GMP compliant
Previous remarks of the Evaluator. Letter No.F.33-1/2018-REG-IV(2nd PRVC) dated:6th
April,2018 from REG-IV that following application recived for
export registeration and later firm informed that application
is for local registration.
Registration Board referred the case to QA & LT Division
to conduct GMP inspection of Firm.(M-285)
Evaluation by PEC Last inspection conducted on 04-09-2018 & 26-09-2018. and
report concludes that ―As per observation made, facilities of
production and quality control inspected, technical staff
employed and keeping in view the overall GMP compliance
status of the firm, the panel unanimously recommends the
renewal of DML 000614 by way of formulation granted to M/s
Welmark KPK‖.
Decision: Approved
782. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Applicant Karachi, 75190, Pakistan
Brand Name +Dosage Form + Strength Leucoarte CA 30mg/10ml Solution for Injection
Composition Each 10ml of ampule Contains:
Folinic Acid as Calcium Folinate………30mg
Pharmacological Group Detoxifying agent for antineoplastic treatment
Type of Form Form 5
Pack size & Demanded Price 1‘s, 10‘s, ; As per SRO
Approval status of product in REFOLINON 3MG/ML SOLUTION FOR INJECTION Of
Reference Regulatory Authorities MHRA Approved
Me-too status (with strength and Not found
dosage form)
GMP status Date of latest Inspection: 16-02-2018 M/s Genix Pharma Pvt. Ltd
Karachi was considered at an satisfactory level of compliance
with CGMP GUIDLINES as of today. The management was also
suggested to further strengthen stability and analytical sections.‖
Previous remarks of the Evaluator.  Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) along with registration
number, brand name and name of firm
Deferred for evidence of applied formulation/drug already
registration number, brand name and name of firm. (M-287)
Evaluation by PEC Due to typographical error the strength was written
30mg/10ml instead of 30mg/3ml (10mg/ml) corrected
formulation is
LeucoArt CA 30mg/3ml Solution for injection
Each 3ml of Ampoule contains:
Folinic Acid as calcium folinate……30mg (10mg/ml)
 Calcium Folinate 10mg/ml (Fill volume 3ml) Austria
approved
 Kunyrin Injection 30mg/3ml Of M/S Al-Habib
Pharmaceuticals
 Fee for correction RS: 20000/- Deposited through challan
No: 0829498 dated : 20-03-2019
783. Name and address of manufacturer / M/S Welmed Pharmaceuticals Industries (Pvt) Ltd., 108,
Applicant R:2 Industrial Estat,Gadoon, District Swabi, Pakistan
Contract manufactured by: Previous: M/S Biolabs (Pvt) Ltd, Plot
# 145, Industrial Triangle, Kahuta Road Islamabad.
Now: Winthrox Laboratories (Pvt) Ltd K-219-A, SITE

highway, phase-II Karachi, Pakistan
Brand Name +Dosage Form + Strength Welrose injection
Iron sucrose complex eq. to emental Iron……….100mg
Pharmacological Group Anti anaemics
Type of Form Form 5
Approval status of product in Venofer Injection by Vifor (MHRA Approved)
Me-too status (with strength and Venofer injection by Gastrocare ,
dosage form)
GMP status Last GMP inspection of Welwrd conducted on 12-07-2018
and the report concludes
All the observations in the inspection were discussed with the
firm management and technical persons. They were committed to
rectify all the observations. The firm may be considerd to be
operating in satisfactory level of cGMP compliance subject to
fulfillment of observations mentioned in the inspection report.‖
&
Last inspection of Bio-Labs conducted on 05-12-2017 & 06-
12-2017 and report concludes that firm is found at fair level of
GMP compliance
Previous remarks of the Evaluator.  Number of sections of applicant approved by Licensing
Board :06
Previous decision(s) (M-285) Deferred for following reasons:
Regsitration Board Board decided to defer all applied products
of contract manufacturing from M/s Bio Labs (Pvt) Ltd. of
Cephalosporin facility, Ampoule general
section and infusion (Non-Antibiotic and Antibiotic) section till
the finalization of inspection
report for assessment and confirmation of manufacturing capacity
of M/s Bio Labs (Pvt) Ltd(M-285)
Evaluation by PEC Change manufacturing facility from M/S Biolabs to M/S
Winthrox.
Previous decision(s) (M-288) Deferred for following reasons
Deferred for updated status of GMP of the firm ―Winthrox‖
form QA & LT division as inspection report was not submitted by
firm (M-288)
Evaluation by PEC Last inspection of Winthrox conducted on 09-10-2018 and report
concludes that overall GMP compliance is rated as good.
Decision: Approved
Contract manufactured by:
Previous: M/S Biolabs (Pvt) Ltd, Plot # 145, Industrial

Brand Name +Dosage Form + Strength Welferol 5mg injection
Cholecalciferol (Vitamin D3) ……….5mg
(Eq to 200,000 IU of vitamin D)
Type of Form Form 5
Pack size & Demanded Price 1ml x 1‘s ; As per SRO
Approval status of product in Vitamin D3 Good 200,000 IU / 1 ml IM solution for
Reference Regulatory Authorities injection of ( ANSM France approved)

Me-too status (with strength and Calciferol Injection M/s Global Pharmaceuticals,
dosage form)
― All the observations in the inspection were discussed with the
&
GMP compliance
Board :06
Winthrox.
firm (M-288)
Evaluation by PEC Last inspection of Winthrox conducted on 09-10-2018 and
report concludes that overall GMP compliance is rated as good.
Decision: Approved
785. Name and address of manufacturer / M/S Welmed Pharmaceuticals Industries (Pvt) Ltd., 108, R:2
Applicant Industrial Estat,Gadoon, District Swabi, Pakistan
Contract manufactured by:
Previous: M/S Biolabs (Pvt) Ltd, Plot # 145, Industrial

Brand Name +Dosage Form + Strength Mecowel 500mcg injection
Mecobalamine…..500mcg
Pharmacological Group Co-enzyme-type vitamin B12
Type of Form Form 5
Finished product Specifications Manufacture‘s specification
Approval status of product in PMDA approved
Me-too status (with strength and Wycomin 500 mcg Injection by Wnsfeild Pharmaceutical,
dosage form)
th
&
GMP compliance
Board :06
Winthrox.
firm (M-288)
Contract manufactured by: Previous: M/S Biolabs (Pvt) Ltd, Plot
# 145, Industrial Triangle, Kahuta Road Islamabad.

Brand Name +Dosage Form + Strength Ketrol-T 30mg injection
Ketorolac trometamol……..30mg
Type of Form Form 5
Approval status of product in Ketorolac of USFDA approved
Me-too status (with strength and Tolek injection by Regal Pharmaceuticals
dosage form)
&
Last inspection of Bio-Labs conducted on 05-12-2017 & 06-12-
2017 and report concludes that firm is found at fair level of GMP
compliance
Board :06
the finalization of inspection report for assessment and
confirmation of manufacturing capacity of M/s Bio Labs (Pvt)
Ltd (M-285)
Winthrox.
firm (M-288)
Decision: Approved
787. Name and address of manufacturer / M/s Invictus Pharmaceuticals, Plot No. 21,26, Street No.NS-2,
Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Creva 10mg Tablets
Rosuvastatin…10mg
Pharmacological Group Statin or HMG CoA Reductase Inhibitor
Type of Form Form -5
Finished product Specifications Manufacturers specification Specifications
Pack size & Demanded Price 1 x 10‘s , 1 x 20‘s, 1 x 30‘s:as per SRO
Approval status of product in Crestor 10mg film-coated tablets by M/s AstraZeneca
Reference Regulatory Authorities UK Ltd (MHRA Approved)
Me-too status (with strength and Easetec 10mg tablet by M/s Pharmatec (Reg#067564)
dosage form)
GMP status Last inspection conducted on 13-11-2018 and panel
recommend grant of DML
Previous remarks of the Evaluator. Correction of Salt form Rosuvastatin as calcium without
submission of fee
Deferred for submission of fee for revision of
formulation.(M-287)
Evaluation by PEC Rs:5000/= fee submitted through challan No;0841674
dated: 14-02-2019
Rosuvastatin…20mg
Me-too status (with strength and Easetec 20mg tablet by M/s Pharmatec (Reg#067565)
dosage form)
submission of fee
Deferred for submission of fee for revision of formulation.
(M-287)
dated: 14-02-2019
Rosuvastatin…40mg
Me-too status (with strength and Rosocard Tablets of M/s Himont Pharma
dosage form)
submission of fee
(M-287)
dated: 14-02-2019
Brand Name +Dosage Form + Strength Epiral 50mg Tablets
Eperisone…….…50mg
Pharmacological Group Muscle relaxant, Centrally acting agent
Type of Form Form 5
Finished product Specifications Manufacturer,s specification
Pack size & Demanded Price 1 x 10‘s, 1 x 20‘s & 1 x 30‘s ; As per SRO
Approval status of product in Expose 50mg film coated tablets by ALFASIGMA
Reference Regulatory Authorities S.P.A.(AIFA Italy Approved)
Me-too status (with strength and Perispa 50 Mg Tablets by Platinum Pharma (R# 039302)
dosage form)
Previous remarks of the Evaluator. Correction of Salt form Eperisone as HCl without submission
of fee .
(M-287)
dated: 14-02-2019
a. New DML
M/s Norwich Pharmaceuticals, Islamabad
CLB in its 267th meeting has granted New license with following 3 sections. The details of products applied for
each section is provided below:
Section No. of molecules applied No. of products applied
Capsule section (Cephalosporin) 05 10
Dry powder injection (Cephalosporin)
Dry powder suspension (Cephalosporin)
The letter was issued on 8th January 2019.
Capsule (Cephalosporin)
10 Products/ 05 Molecules
791. Name and address of manufacturer / M/s Norwich Pharmaceuticals, Plot No. 220, Industrial
Applicant Triangle, Kahuta Road, Islamabad, Pakistan
Brand Name +Dosage Form + Strength Ceficlor 250mg Capsule
Cefaclor Monohydrate Eq. to Cefaclor…250mg
Pharmacological Group Cephalosporins
Type of Form Form 5
Approval status of product in Cefaclor Capsules 250mg (Cefaclor monohydrate Ph Eur Eq. to
Reference Regulatory Authorities 250mg of Cefaclor) by Strides Pharma UK Ltd.
Approved by MHRA
Me-too status (with strength and Resclor 250 mg Capsules by M/s Genome Pharmaceuticals
dosage form)
GMP status New license
Decision: Approved
Brand Name +Dosage Form + Strength Ceficlor 500mg Capsule
Diary No. Date of R& I & fee Dy.No 3385 dated 24-01-2019 Rs.20,000/- Dated 24-
01-2019
Type of Form Form 5
Reference Regulatory Authorities 500mg of Cefaclor) by Strides Pharma UK Ltd.
Approved by MHRA
Me-too status (with strength and Resclor 500 mg Capsules by M/s Genome Pharmaceuticals
dosage form)

Decision: Approved
Brand Name +Dosage Form + Strength Rulex 250mg Capsule
Cephalexin Monohydrate Eq to Cephalexin…250mg
01-2019
Type of Form Form 5
Approval status of product in Cephalexin Capsules of USFDA approved
Me-too status (with strength and Defmat 250mg Capsule by M/s Martin Dow
dosage form)
Decision:
Brand Name +Dosage Form + Strength Rulex 500mg Capsule
Cephalexin Monohydrate Eq to Cephalexin…500mg
01-2019
Type of Form Form 5
Approval status of product in Cephalexin Capsules of USFDA approved
Me-too status (with strength and Defmat 500mg Capsule by M/s Martin Dow
dosage form)
Decision: Approved
Brand Name +Dosage Form + Strength Cecil 500mg Capsule
Cefadroxil Monohydrate Eq. to Cefadroxil…500mg
Type of Form Form 5
Approval status of product in Cefadroxil Capsules of MHRA approved
Me-too status (with strength and Gabadrox 500mg Capsule by M/s Gaba Pharma
dosage form)
Decision: Approved

Brand Name +Dosage Form + Strength Cecil 1g Capsule
Cefadroxil Monohydrate Eq. to Cefadroxil…1000mg
Type of Form Form 5
Approval status of product in Could not found
Me-too status Gabadrox 1g Capsule by M/s Gaba Pharma
Remarks of the Evaluator Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/ approved
by the Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength Cefrid 250mg Capsule
Cephradine Monohydrate Eq. to Cephradine…250mg
Type of Form Form 5
Approval status of product in Cefradine Capsules of MHRA approved
Me-too status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)
Decision: Approved
Brand Name +Dosage Form + Strength Cefrid 500mg Capsule
Cephradine Monohydrate Eq. to Cephradine…500mg
Type of Form Form 5
Approval status of product in Cefradine Capsules of MHRA approved
Me-too status Dinar 500mg capsule by Baxter Pharma
Decision: Approved
Brand Name +Dosage Form + Strength Micef 200mg Capsule
Cefixime Trihydrate Eq. to Cefixime…200mg

Type of Form Form 5
Approval status of product in CEFIXIMA NORMON 200 mg CAPSULAS by M/s
Reference Regulatory Authorities Laboratorios Normon, S.A., Spain approved
Me-too status (with strength and Xime 200 mg Capsulesby M/s Fedro Pharmaceutical,
dosage form)
Decision: Approved
Brand Name +Dosage Form + Strength Micef 400mg Capsule
Cefixime Trihydrate Eq. to Cefixime…400mg
Type of Form Form 5
Approval status of product in Suprax of (USFDA approved)
Me-too status (with strength and Maxophine Capsules of M/s Global Pharmaceuticals,
dosage form)
Decision: Approved
Case No. 03: Registration Applications of Import Cases.

801. Name and address of Applicant M/s Muller & Phipps Pakstan (Pvt) Ltd., Uzma court, Main
Clifton Road, P.o Box 3880 karachi- 75600 Pakistan
Detail of Drug Sale License Address:Plot No. 208& 208/1 sector 23 Korangi Industrial
Area Karachi.
Validity : 03/10/2019
Status: drug to sell drugs in a wholesale distributor
Name and address of manufacturer M/s Fresenius Kabi Austria GmbH Hafnerstrasse 36 A-8055
Graz / Austria
Name and address of marketing M/s Fresenius Kabi Deutschland GmbH D- 61346 Bad
authorization holder Homburg v. d. Hohe
Diary No. & Date of R& I Dy No : 1548 Dated : 04/05/2017
Fee including differential fee Rs : 1,00,000 Dated : 04/05/2017
Brand Name +Dosage Form + Strength SMOFlipid 20% emulsion for Infusion
Composition 1000ml contains :
Soya-bean oil,refined…………...........60gm
Triglycerides,medium chain………....60gm
Oliv oil, refined……………………...50gm
Fishg oil, rich in omega 3- acids…….30gm
Finished Product Specification Inhouse Specifications
Pharmacological Group Fat Emulsion (Solution for parenteral nutrition)

Demanded Price 10 x 100ml Rs; 6470.5/-
Unite Price of one bottle Rs; 647.5/-
10 x 250ml Rs; 10059/-
Unite price of one bottle Rs; 1005.90/-
10 x 500ml Rs; 19706/-
Unite price of one bottle Rs; 1970.60/-
Pack size 250ml,
International availability USFDA Approved
Me-too status N/A
Detail of certificates attached Valid and Legalized CoPP
Certificate No: ROBQ4
Certified by: Regierungsprasiddiun Darmstadt Luisenplatz 2 d-
64278 Darmstadt
Issued on : 07/02/2017
Free sale: Confirms the free sale of the product in exporting
country.
GMP certificate
GMP certificate No : INS-480166-0085-001(13/15)
Date of Inspection: 05-02-2018
Valid until : 3 years
Sole Contract Agreement
16-04-2018
Remarks of the Evaluator. Short coming Reply of firm
communicated
Address on form 5-A and This is to certify that Muller &
address on Drug sale Phipps Pakistan (Pvt) Ltd, has
License is change registred office at Uzma court,
Main Clifton Road, P.o Box
3880 karachi- 75600 Pakistan
and our central warehouse is
located at plot No 208 & 208/1,
Sector -23, Korangi Industrial
area Karachi, Where the
products are recived, stored and
transferred to other M&P
establishment all over the
Pakistan.
Stability study data for real 2 batches (WA1519 and
time is not for 3 batches. WA1523) were put on stability
at 30°C in order to gather more
information about the product
As this temperature was
used for stability solely as a
back-up (at that time), not all
batches were put on stability at
30°C
Accelerated stability study Accelerated studies were
is performed at 40°C ± 2°C / performed with the original
NMT 25%RH in glass primary packaging material,
container . Please clarify. which is glass container = see
ICH Topic Q 1 A (R2)
2.2.4 Container-closure system:
―Stability testing should be
conducted on the dosage form
packaged in the
primary container-closure
systems proposed for
marketing(including , as
appropriate, any secondary
packaging and container label).
Any available studies carried out
on the
FPP outside its immediate
container or in other packaging
materials can form a useful part
of the stress testing of the
dosage form or can be
considered as
supporting information,
respectively. ‖
As glass container are

impermeable containers, the
relative humidity is not relevant
according to ICH Topic Q 1 A
(R2)
2.2.7.2 FPPs packaged in

impermeable containers:
―Sensitivity to moisture or
potential for solvent loss is not a
concern for
FPPs packaged in impermeable
containers that provide a
permanent barrier
to passage of moisture or
solvent. Thus stability studies
for products stored in
impermeable containers can be
conducted under any controlled
or ambient RH
condition.‖
In case of long term The registred and relevant
stability the result at 30°C of labelled conditions for
°
non esterified fatty acid at SMOFlipid 20% is up to 25 C.
24 month is out of As it is known that SMOFlipid
specification. So clarify . 20% is not stable for 24 month
at 30°C , Fresenius Kabi has
reduced the shelflife to 18
months in countries with a
labelled storage condition of up
to 30°C
In future allongoing stabilities
for SMOFlipid 20% at 30°C will
be only tested and reported up to
18 months.
Decision: Registration board Deferred the case for following reason:
 Submission of stability data of 3rd batch as provided data is of only 2 batches.
 Accelerated stability study conducted at at 40°C ± 2°C /75±5%RH as per zone-IV A
requirement.

Case No. 04: Registration Applications of Drugs for which Stability Study Data is
Submitted.
a. New Cases.
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No of Manufacturer / (Proprietary Name + Initial Diary & Availability / Local Decision /
. Applicant Dosage Form + Date, Fee Availability Remarks
Strength), (including (if any)
Composition, differential GMP Inspection Report
Pharmacological fee), Date & Remarks
Group, Demanded
Finished Product Price / Pack
Specification size
802. M/s Pharmedic Hepvir 400mg Tablets Form-5 Sovaldi Tablets by
Laboratories (Pvt) Each film coated tablet 29-05-2015 US FDA approved
Ltd, 16-KM contains: Dy.No.316
Last inspection report 07-
Multan Road, Sofosbuvir Rs.20,000/-
08-2018, 04-09-2018 &
Lahore- Pakistan ………..400 mg 28‘s
22-11-2018 and
Rs; 55000/28
conclusion of report is
Based on the findings of
Antihepatitis
the inspection and the
improvements made by
(Manufacturers the firm, the panel of
specifications)
inspectors recommends
resumption of production
in the liquid injectable
section (gen).
2- The matter of
unauthorized production in
Liquid injectable section
(gen) had already been
forward to the directorate
of QA and LT vide letter
no 11210/2018-DRAP (L-
VII) dated 24-08-2018 for
necessary action.
3- Firm was advised to
rectify the observations
made during the CGMP
inspection and submit
compliance report.
Drug Hepvir 400mg Tablet
Name of Manufacturer M/s Pharmedic Laboratories (Pvt) Limited
Manufacturer of API M/s Pharmagen Ltd., Kot nabi Bukhsh Wala, 34-KM, Ferozepur Road, Lahore
API Lot No. 00511211/001/2017
Description of Pack Alu/Alu
(Container closure
system)
Stability Storage Accelerated: 40°C ± 2°C & 75±5%RH
Condition Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 06 Months
Frequency Accelerated: 0,1,2,4,3,6 (Month)
Real Time: 0,3,6(Month)
Batch No. SOF-TR-07 SOF-TR-08 SOF-TR-09
Manufacturing Date May – 2018 May – 2018 May – 2018
No. of Batches 3
1. COA of API Copy of COA M/s Pharmagen Ltd Pakistan is
submitted.
2. Approval of API by regulatory authority of country of Copy of GMP Certificate Ref. No. 06/2019- DRAP
origin or GMP certificate of API manufacturer issued by (AD/607409-530) Dated: 11-01-2019 issued by
regulatory authority of country of origin. DRAP is submitted.
3. Protocols followed for conduction of stability study and Yes
details of tests.
respective documents like chromatograms, laboratory
5. Documents confirming import of API etc. Local source (not valid)
6. All provided documents will be attested (name, sign and Yes
7. Commitment to continue real time stability study till Yes
Initially submitted incomplete data of one batch that is SOF-TF-06 containing methylene chloride as excipient.
Now they submitted three new trial batches with revise formulation without methylene chloride .
Decision: Registration Board deferred for updated report on GMP compliance. Incase of satisfactory report, panel
shall be constituted for onsite verification of stability study.
Sr. Name & Address Brand Name Type of Form, International Availability / Previous DRB
No. of Manufacturer / (Proprietary Name + Initial Diary Local Availability Decision /
Applicant Dosage Form + & Date, Fee Remarks
Strength), (including GMP Inspection Report Date (if any)
Composition, differential & Remarks
Pharmacological fee),
Group, Demanded
Finished Product Price / Pack
Specification size
803. M/S Barrett Eye Aid Ophthalmic Form 5D Prolensa
Hodgson Pakistan Solution 0.07% New Section 0.07% ophthalmic
(Pvt) Ltd. f/423, Each ml contains: 03-04-2014 solution
SITE, Karachi- Bromfenac Dy. No.379 US FDA
75700- Pakistan Sodium Rs.50,000/-
Sesquihydrate (Duplicate Last inspection report 20-02-
0.0805% (eq. to Dossier) 2018 and report concludes that
Bromfenac free firm is operating at
acid……….. 0.7mg 1.6ml/ satisfactory level of GMP
Rs: 575/- compliance.
Non-Steroidal 3ml/RS:1025/
anti-inflammatory -
5ml/Rs:1695/-
(Manufacturers
specifications)
Drug Eye Aid Ophthalmic Solution 0.07%
Name of Manufacturer M/S Barrett Hodgson Pakistan (Pvt) Ltd.
Manufacturer of API M/s Enaltec Labs 17th floor, Kesar Solitaire Plot No: 5, Sector19, Sanpada Navi
Mumbai, Maharashtra
M/s Indoco remedies limited, Kilo Lab R-92 – 93, T.T.C, MIDC, Thane Belapur Road,
Rabble, New Mumbai
API Lot No. M/s Enaltec Labs EL- 03/A007/13002
M/s Indoco remedies RK13BRN001
Description of Pack LDPE
(Container closure
system)
Stability Storage Accelerated: 40°C ± 2°C /NMT 25%RH
Condition Real Time: 30°C ± 2°C / 35±5%RH
Frequency Accelerated: 0,1,3,6 (Month)
Real Time: 0,3,6(Month)
Batch No. EXP-OP-160 PLT-OP-005 PLT-OP-006
Batch Size 500ml 1 liter 1 liter
Manufacturing Date May – 2015 Nov-2016 Nov-2016
Date of Initiation June-2015 Dec-2016 Dec-2016
No. of Batches 3
1. COA of API Copy of COA from M/s Enaltec Labs is submitted.
Copy of COA from M/s Indoco remedies is submitted.
2. Approval of API by regulatory authority of Copy of GMP of Indoco Remedies Certificate No. NEW-WHO-
country of origin or GMP certificate of API GMP/CERT/KD/59732/2017/11/21539 issued by Food & Drug
manufacturer issued by regulatory authority Adminstration, M. Bandra-kurla Complex Bandra, Mumbai- 400
of country of origin. Maharashtra is submitted.
Copy of GMP of Enaltec Labs Certificate No. 6078745 issued
by Food & Drug Adminstration, Maharashtra is submitted.
3. Protocols followed for conduction of Yes
sheets etc.
5. Documents confirming import of API etc. No

6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
Rules, 1978.
 Batch no : EXP-OP-160 is manufactured from Indoco Remedies Bromfenac Sodium Sesquihydrate Batch No:
RK13BRN001
 Batch no : PLT-OP-005 is manufactured from Enaltec Lab Bromfenac Sodium Batch No: EL-03/A007/13002
 Batch no : PLT-OP-006 is manufactured from Enaltec Lab Bromfenac Sodium Batch No: EL-03/A007/13002
 For Batch No: EXP-OP-160 they performed Long term stability study for 24 months while for Batch no : PLT-
OP-005 & Batch no : PLT-OP-006 6 months long term stability study.
 Documents confirming import of API etc:
In reference to letter No. F.1-1/2017/PEC- DRAP (AD PEC- IV) dated :02 May, 2018 firm requested for
extension
1) On 4th May, 2018 request for extension till 30 May, 2018
2) On 28th May, 2018 request for extension till July, 2018
3) On 23rd May, 2018 request for extension till 31 October, 2018
4) On 25th January, 2018 request for extension till 30 June, 2019
5) On 26th April, 2018 request for extension till 30 June, 2019
Decision: Registration board after thorough deliberation decided to reject the above applied application as
firm has not submitted documents confirming import of API for conduction of stability study not submitted
since more than one year.
b. Verification of stability study data

Sr. Name & Address of Brand Name Type of Form, International Previous DRB
No. Manufacturer / (Proprietary Name + Initial Diary & Availability / Local Decision /
Applicant Dosage Form + Date, Fee Availability Remarks
Strength), (including (if any)
Pharmacological Demanded Price Report Date &
Group, / Pack size Remarks
Finished Product
Specification
804. M/S Indus Pharma Exilant 60mg Capsule Form 5 D Dexilant Delayed Differential fee of
(Pvt) Ltd Plot No. 26, Each HPMC capsule 30-01-2018 Release Capsule Rs: 50000
27,63, 64, 65, 66 & contains: Dy. No.3745 60mg of Deposit slip No:
67, Sector-27, Rs.50,000/- USFDA approved 0742299 dated
Korangi Industrial Dual Delayed Release 02-07-2018
Area Karachi. dexlansoprazole pellets 14‘s Last inspection was submitted for
23% eq to As per SRO conducted on 16- pellets.
Dexlansoprazole 08-2017 and report
….………..60mg concludes that firm
was considered to
Proton Pump inhibitor be operating at an
(Manufacturers acceptable level of
specifications) GMP compliance
Drug Exilant 60mg Capsule
Name of Manufacturer M/S Indus Pharma (Pvt) Ltd Karachi
Manufacturer of API M/S Murli Krishan Pharma Pvt Ltd, India

API Lot No. MKPPLR-DEF-17001
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, ,3,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. P-1/DEX CAPS P-2/DEX CAPS P-3/DEX CAPS
Batch Size 2,500 capsules 2,500 capsules 2,500 capsules
Manufacturing Date June– 2017 June – 2017 June – 2017
No. of Batches 3
Date of Submission 30-01-2018 (Dy. No3745)
1. COA of API Copy of COA from M/s Murli Krishan Pharma Pvt Ltd
India is submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate No. New-WHO-
country of origin or GMP certificate of API GMP/CERT/PD/52224/2017/11/18462 issued by Food &
manufacturer issued by regulatory authority of Drug administration, M.S. Bandra-Kurla Complex,
country of origin. Maharashtra, India is submitted.
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested dated: 10-10-2017
Commercial Invoice No MKPPL/RG/011 Dated: 24-05-
2017 issued by M/s Murli Krishan Pharama, India is
submitted.
sign and stamp) for ensuring authenticity of
data / documents.
Rules, 1978.
 Commercial Invoice of API was attested by ADC Karachi on 10-10-2017 while all the 3 batches are produced
in june 2017 and stability starts on 15-06-2017 .
 Firm reply:
 ―Kindly note that the request for the issuance of form6/Clearnce certificate was submitted to DRAP- Karachi
in letter dated 29th May 2017 along with required document.
We further investigated the concern from your office and were informed by the respective personnel of the
concern department of Indus Pharma that during the evalution of our application by Drap- Karachi, we were
informed by the Pakistan customs that our consignment of Dexlansoprazole DDR pellets 23% - 2.5 Kg for the
testing and trial/Developmental Batches, had been released via the Green channel by the customs on 3rd June 2017,
based on the submissionof soft copies of the essential documents on the computerized system weboc (web based one
custom) of the Pakistan customs. We had the consignment cleared accordingly and was used for testing and
development of trial batches in June 2017 and put on stability accordingly
As our application was al;ready filled in DRAP – Karachi, We received the Form-6 along with ADC/Ad
attested commercial invoice on 10th October 2017‖
 Certificate of analysis of API by manufacturer submitted is for different batch No than batch No mentioned
on commercial invoice
Firm reply:
Kindly note that the batch No in certificate of analysis is a typographical error. The correct batch No is MKPPLR-
DEF-17001 as mentioned in commercial invoice instead of MKPPLR-DLF-17001
Decision: The Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc.
Prof. Dr. Rafeeq Alam Khan, Member Registration Board.
Dr. Saif ur Rehman Khattak, Director/FGA, CDL, Karachi.
Mr. Sajjad Abbasi, FID, Karachi.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Exilant 60mg
(Dexlansoprazole) Capsules by M/s. Indus Pharma (Pvt.), Korangi Industrial Area, Karachi.
Reference No: F.13-11/2017-PEC (PT) dated 17th January, 2019.
Investigation Site: Factory premises of M/s. Indus Pharma (Pvt.) Limited, Korangi Industrial Area, Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Indus Pharma, Plots No. 26, 27, 63-67, Sector 27,
Korangi Industrial Area, Karachi for registration of Exilant 60mg (Dexlansoprazole) Capsules and constituted a
three-member panel to investigate the authenticity / genuineness of data (import of raw material and stability data).
Panel was advised to conduct inspection of the firm and to submit report for further consideration.
3. Dr. Sajjad Abbasi, Area FID, DRAP Office, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing of
stability batches and stability studies on these batches.

The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel involved,
ongoing studies, printed data and integrity and security of data in respective databases were also audited. The details
of investigation may be summarized as under:
Sr.
Question Observation bypanel
No.
1. Doyouhavedocumentsconfirmingthe import Thefirmhasimported2.5kgDexlansoprazole
ofDexlansoprazole API including pelletsfromM/sMurli Krishna,Indiainvoice number:
approvalfromDRAP? MKPPL/RG/011 dated 24/05/2017.Approval fromDRAP
Office,Karachi was obtained on 10/10/2017 i.e. after a
period of 4 months.
2. Whatwastherationalebehindselecting the There is proper vendor evaluation process being
particularmanufacturerofAPI? implementedincludingPostalAuditchecklist,Testingof the
APIand GMP approvalbycompetentauthority along with the
DMF.
3. Do you have documents confirming the The firm has document confirming the imported
import of Dexlansoprazole reference standard Dexlansoprazole pellets(API), working standard of the API
and impurity standard? and 2 major impurities from the manufacturer of the API.
4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API, working
API, reference standard of the API and standard of the API and 2 major impurities standards.
impurity standard?
5. Do youhave GMP certificate of API The firm has valid GMP certificate of the API
authoritiesofcountryoforigin? Regulatory Authority of the country of origin.
6. Do you use API manufacture rmethod of The firm has used API manufacturer method for testing
testing for testing API? API.
7. Doyouhavestabilitystudiesreporton API? The firmhasstabilitystudies reports on the API.
8. If yes, whether the stability testing has been The stability testing has been performed as per SIM method
performed as per SIM method and and degradation products have been quantified.
degradation products have been
quantified?
9. Do you have method for quantifying the The firm has HPLC method for quantifying the impurities
impurities in the API? in the API.
10. Do you have some remaining quantities of the The firm has remaining quantities of the API, and working
API, its reference standard and impurities standard of API only.
standards?
11. Have you used pharmaceutical grade No excipients used, Only HMPC based capsule shells as
excipients? used by the innovator. (Dexilant capsule manufactured by
Takeda Pharma)
12. Do you have documents confirming the The firm has necessary documents confirming the import of
import of the used excipients? the used excipient.
13. Do you have test reports and other records on The firm has test reports and other records on the excipient
the excipients used? used.
14. Do you have written and authorized protocols The firm has written and authorized protocols for the
for the development of Dexlansoprazole development of Exilant Capsules 60mg
capsules? (Dexlansoprazole).
15. Have you performed Drug-excipient Same excipients were used as of innovator.
compatibilitystudies?
16. Have you performed comparative The firm has performed comparative dissolution studies on
dissolution studies? their capsules against the innovator product Dexilant
Capsules 60mg batch no/lot no. A25777, Manufactured By:
Takeda Pharma, USA). The firm‘s product has comparable
dissolution profile with that of the innovator product.
17. Doyouhaveproductdevelopment(R&D) The firm does not have dedicated product development
section? section.They have equipment‘s for manufacturing lab scale
batches. Some of these equipments are used while shifting
them to the commercial manufacturing area, whereas,
some equipments of commercial scale manufacturing are
being used for product development.
Dedicated area for product development is under

renovation. New small-scale equipment for R%D have
arrived at the facility and will be commissioned after
renovation work is completed.
18. Do you have necessary equipment As above.
available in product development section for
development of Dexlansoprazole capsules?
19. Are the equipment in product The available equipment for productdevelopment section
development section qualified? are qualified.
20. Do you have proper maintenance The firm has propermaintenance/calibration with re-
calibration/re-qualification program for the Qualification program for the equipment used for product
equipment used in PD section? development.
21. Do you have qualifiedstaffinproduct The firm has a team of 05 technical persons (04 Pharmacist
development section with proper &1 MSC Chemistry) for product development. These
knowledge and training in product personnel have proper knowledge and trainining product
development? development.
22. Have you manufactured three stability batches The firm has manufactured three stability batches of
for the stability studies of Dexlansoprazole Exilant Capsules 60mg capsules having batch # P-
capsules as required? 1/DEX, P-2/DEX and P-3/ DEXeach of 2500 capsules
batch size.The capsulesare packed in Alu Alu blisters of
pack size 2x7s.
23. Do you have any criteria for fixing the batch The criteria for fixing the batch size of stability batches is
size of stability batches? the quantity of capsules required per testing frequency and
the number of testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. All the Log Books are properly maintained.
26. Do you have developed and validated the The method is based upon the API method of API
method fortesting of stability batches? manufacturer. The firm has fully validated the method for
testing of their finished product.
27. Doyouhavemethodtransferstudiesin The firmhasperformed complete validation studies.
casewhenthemethodoftestingbeing
usedbyyourfirmisgivenbyanyother lab?
qualification of equipments/instruments qualificationofequipment/instrumentsbeingusedinthe
being used in the test and analysis of testandanalysis ofthe APIand the finished drug.
Dexlansoprazole API and the finished drug?
29. Do your method of analysis stability The firm has performed forced degradation (FD) study on
indicating? their product Exilant Capsules 60mg capsules for the
conformance of stability indicating nature of their method
for testing the finished product during stability studies.
30. Do your HPLC software 21CFR 1. Yes, HPLC software is 21 CFR Part 11
Compliant? compliant where all user levels are properly
defined.
2. No user or main user can delete, edit or
manipulate data from software.
4. Created strict policies on windows and disable
options like ―Delete, Copy, Paste and rename‖
of any file from user level.
Furthermore, the following improvements are being made
in order to strengthen it further.
1. A new HPLC of ―Agilent Infinity series‖ has
been installed in Quality Control Laboratory &
two more are under procurement and will be
commissioned by the mid of 2019.
2. Chromatography Data System (CDS) Software
is also being procured for Compliance and
Data Security.
With the ever-evolving emphasis on data security, data
integrity, and compliance, it is of vital importance that the
software provides comprehensive preventive and detection
technical controls. This will enable us to meet the latest
regulatory requirements and ensure the highest levels of
data quality.
31. Can you showAudit trail reports on Audittrailonthetestingreports is available.
Dexlansoprazoletesting?

32. Do you have some remaining quantities of The firm has remaining quantities of stability batches only.
degradation products and stability
batches?
33. Do you have stability batches kept on The firm has three stability batches kept on realtime
stability testing? stability testing. 18months studies have been completed on
these batches with satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the equipment used
equipments used in Dexlansoprazole in Exilant Capsules 60mg production and analysis.
capsules production and analysis?
35. Do proper and continuous monitoring and Adequatemonitoringandcontrolareavailableforstability
control are available for stability chambers including data loggers and centralized
chamber? controllingsoftware.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be rated as utilities are in compliance.
GMP compliant?
Conclusions:
for registration of Exilant 60mg (Dexlansoprazole) Capsules is verifiable to satisfactory level .
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited
For the manufacturing of Exilant 60mg (Dexlansoprazole) Capsules.
Recommendations:
1. Since Exilant 60mg Capsules are modified release (delayed release) capsules therefore, post registration
Bioequivalence studies should be conducted on the product before marketing.
2. Firm must developed specific identification test for dexlansoprazole in the pallets and the finished product .
3. The firm may kindly be granted necessary registration of Exilant 60mg (Dexlansoprazole) Capsules.
Note: The firm has submitted written undertaking for post registration bioequivalence studies on the capsules
(copy enclosed
Decision: Deferred for following reason:
 Commercial Invoice of API was attested by DRAP Karachi on 10-10-2017 while all the 3 batches are
produced in june 2017 and stability starts on 15-06-2017 .
 Recommendation by panel that ―Firm must developed specific identification test for dexlansoprazole
in the pellets and the finished product‖
c. Exemption from onsite verification of stability data

Strength), Composition, differential fee),
Finished Product Pack size Report Date
Specification
805. M /s. Scotmann Voreta Tablets 10 mg Form 5 Jardiance Tablets 10
Pharmaceuticals, Each Film Coated tablet Dairy No.4415 mg by Boehringer
5D, I-10/3, contains: Dated:31-01-2019 Ingelheim
Industrial Area, Empagliflozin Rs.20,000/- dated: Pharmaceuticals,
Islamabad …………10mg 31-01-2019 USFDA
GMP Inspection
Anti-Diabetic Drug, 1x10‘s, 1x14‘s, conducted on
Sodium-Glucose Co- 2x7‘s, 4x7‘s, 10-10-2018
Transporter2 (SGLT2) 3x10‘s, 30‘s, & 17-10-2018
Inhibitor. 2x10‘s; concluded
As per SRO that the panel
(Manufacturer‘s unanimously
Specification) recommended for
the grant of
cGMP certificate.
Drug Voreta Tablets 10 mg
Name of Manufacturer M/s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.
Manufacturer of API Empagliflozin: M/s Zhejiang Huahai Pharmaceutical Co. Ltd., China
API Lot No. D5284-17-004
Description of Pack
Alu Alu Blister Pack
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 06 months
Real Time: 0, 3,6, (months)
Batch No. Trial # 01 Trial # 01 Trial # 01
Manufacturing Date 02/2018 02/2018 02/2018
Date of Initiation 15/2/2018 15/2/2018 15/2/2018
No. of Batches 03
Date of Submission 30-01-2019 (4213)
No.
1. COA of API. Copy of COA (Batch#D5284-17-004) from M/S
Zhejiang Huahai pharmaceuticals CO; Ltd China is
submitted.
2. Approval of API by regulatory authority of country Copy of GMP Certificate (certificate No.ZJ20140072)
of origin or GMP certificate of API manufacturer issued by China Food & Drug Administration China.
issued by regulatory authority of country of origin. It is valid until 25/09/2019.
Yes
5. Documents confirming import of API etc. Copy of Form 6 (License to Import drug for clinical trial
examination, test or analysis) issued by ADC DRAP
(Islamabad) dated 14-07-2017, for the import of
Empagliflozin from M/s Zhejiang Huahai
Pharmaceuticals CO; Ltd and
Copy of Commercial Invoice (invoice No.
HH20171596, dated: 17-07-2017) attested by ADC
DRAP (Islamabad) dated 27-07-2017 is also submitted
sign and stamp) for ensuring authenticity of data / Yes
documents.
Yes
1978.


instant dosage form conducted during last two product Dascot Tablets 30mg and 60 mg and Velscot
years. 400mg/100mg tablets which was conducted on 26th
January, 2018 and was presented in 278th meeting of
Registration Board held on 29-31st January, 2018.
According to the report following points were confirmed.
 The firm has 21 CFR compliant HPLC software
 The firm has audit trail reports available.
 The firm possesses stability chambers with digital
data loggers.
2. Documents for the procurement of API with Copy of Form 6 (License to Import drug for clinical trial
approval from DRAP (in case of import). examination, test or analysis) issued by ADC Drap
Empagliflozin from M/s Zhejiang Huahai Pharmaceuticals
CO; Ltd China and Copy of Commercial Invoice (invoice
No. HH20171596, dated: 17-07-2017) attested by ADC
Drap (Islamabad) dated 27-07-2017 are submitted.
3. Documents for the procurement of reference The firm has submitted photocopy of Invoices for the
standard and impurity standards. procurement of reference standard and impurity standards.
4. Approval of API/ DML/GMP certificate of API The firm has submitted GMP Certificate No: ZJ20140072
manufacturer issued by regulatory authority of from M/S Zhejiang Huahai pharmaceuticals CO; Ltd China
country of origin. is submitted. Issued by China Food & Drug Administration
China.
It is valid until 25/09/2019.
5. Mechanism for Vendor pre-qualification The firm has submitted photocopy of ―SOP for Selection of
manufacturer for API/Excipient and Procurement
Procedure.
6. Certificate of analysis of the API, reference The firm has submitted
standards and impurity standards COA of API Batch No.D5284-17-004
COA of Reference Std Batch No. 2015-583
COA of Empagliflozin Ethoxy Impurties
Batch No.2016-1024
7. Documents for the procurement of excipients used The firm has submitted photocopy of Purchase
in product development? Order/Invoices for the procurement of excipients used in
product development
development with relevant experience. involved in product development
Production Data
9. Authorized Protocols/SOP for the development & The firm has submitted photocopy of Development
stability testing of trial batches. Protocol for Lab scale batch manufacturing of Voreta
tablets 10mg.

10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch Manufacturing
stability batches. Record of the following 03 Batches
Batch No. Batch Size Mfg. Date
Trial #01 1200 Tablets 02-2018
11. Record of remaining quantities of stability The firm has submitted reconciliation sheet mentioning
batches. remaining quantity of three trial batches.
The detail is as under:
Trial Total no. of Used Remaining

no. tablets for quantities quantities
stability
01 450 tabs 224 tabs 226 tabs
QA / QC DATA
12. Record of Digital data logger for temperature and Firm has submitted photocopies of data logger record for
humidity monitoring of stability chambers (real Accelerated stability chamber from 16-01-2018 to 01-09-
time and accelerated) 2018 and for Real Time stability chamber starting from 16-
01-2018 to 01-09-2018
13. Method used for analysis of API along with COA. The firm has submitted photocopy of method used for
analysis of APIs (Empagliflozin) along with COA.
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. Specifications and Testing Method of Voreta Tablets
chromatograms, lab reports, raw data sheets etc.) 10mg.
Complete record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets etc.) are
submitted with 06 months stability data (Accelerated &
Real Time).
15. Reports of stability studies of API from The firm has submitted copy of accelerated, 06 Months
manufacturer. (40°C ± 2°C & 75±5%RH) &long term, 24 Months (30°C
± 2°C & 65±5%RH) stability study reports of 03 batches of
Empagliflozin from Zhejiang Huahai Pharmaceuticals CO;
Ltd China.
16. Analysis reports for excipients used. The firm has submitted copies of Analytical reports for all
excipients used in product development of Voreta 10 mg
tablets.
17. Drug-excipients compatibility studies. The firm has stated that we manufactured lab scale batches
of our applied products ―Voreta Tablets‖ by using same
formulation (excipients) of Innovator‘s Product.
18. Record of comparative dissolution data. Firm has submitted Comparative dissolution study of their
product (Voreta Tablets) with Innovator‘s Brand ―Jardiance
Tablets‖ The details are as follows:
Feature Reference. Product
Brand Name Jardiance Tablets 10mg
Batch No. 607110
Mfg. Date 09/2016
Exp. Date 09/2019
Comparative dissolution studies have been performed in
following media:
i. pH 1.2 HCl solution.
ii. pH 4.5 Acetate buffer solution.
iii. pH 6.8 phosphate buffer solution.
Copy of Calculation Sheets and HPLC chromatograms has
been submitted for Comparative dissolution studies..
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports for complete stability
audit trail reports on product testing. studies analysis of three batches, comparative dissolution
and method of testing.
Decision: Registration Board decided to approve registration of ―Voreta Tablets 10 mg (Empagliflozin)‖ with
Innovator‘s specifications by M /s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.
Sr. Name & Address Brand Name Type of Form, International Availability / Local
No. of Manufacturer / (Proprietary Name + Initial Diary & Availability
Pharmacological Group, Demanded Price /
Specification
806. M /s. Scotmann Voreta Tablets 25 mg Form 5 Jardiance Tablets 25 mg by Boehringer
Pharmaceuticals, Each Film Coated tablet Dairy No.4416 Ingelheim Pharmaceuticals,
5D, I-10/3, contains: Dated: 31-01-2019 USFDA
Industrial Area, Empagliflozin….25mg Rs.20,000/- dated
Islamabad 31-01-2019 GMP Inspection conducted on
Anti-DiabeticDrug, 10-10-2018 & 17-10-2018 concluded
Sodium-Glucose Co- 1x10‘s, 1x14‘s, that the panel unanimously
Transporter2 (SGLT2) 2x7‘s, 4x7‘s, recommended for the grant of
Inhibitor. 3x10‘s, 30‘s, cGMP certificate.
(Manufacturer‘s 2x10‘s;
Specification) As per SRO
Drug Voreta Tablets 25 mg
API Lot No. D5284-17-004
Description of Pack
Real Time: 30°C ± 2°C/65%±5% RH
Batch No. B# T-01 B# T-02 B# T-03
No. of Batches 03

No.
1. COA of API. Copy of COA (Batch#D5284-17-004) from M/S
Zhejiang Huahai pharmaceuticals CO; Ltd China is
submitted.
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer Copy of GMP Certificate (certificate No.ZJ20140072)
issued by regulatory authority of country of origin. issued by China Food & Drug Administration China.

Yes
5. Documents confirming import of API etc. Copy of Form 6 (License to Import drug for clinical trial
examination, test or analysis) issued by ADC DRAP
Empagliflozin from M/s Zhejiang Huahai
Pharmaceuticals CO; Ltd and Copy of Commercial
Invoice (invoice No. HH20171596, dated: 17-07-2017)
attested by ADC DRAP (Islamabad) dated 27-07-2017
is also submitted
documents.
Yes
1978.

data loggers.
2. Documents for the procurement of API with Copy of Form 6 (License to Import drug for clinical trial
approval from DRAP (in case of import). examination, test or analysis) issued by ADC Drap

No. HH20171596, dated: 17-07-2017) attested by ADC
Drap (Islamabad) dated 27-07-2017 are submitted.
4. Approval of API/ DML/GMP certificate of API The firm has submitted GMP Certificate No: ZJ20140072
manufacturer issued by regulatory authority of from M/S Zhejiang Huahai pharmaceuticals CO; Ltd China
country of origin. is submitted. Issued by China Food & Drug Administration
China.
Procedure.
6. Certificate of analysis of the API, reference The firm has submitted
Batch No.2016-1024
product development
Production Data
stability testing of trial batches. Protocol for Lab scale batch manufacturing of Voreta
tablets 25mg.
T#01 1200 Tablets 02-2018
T#02 1200 Tablets 02-2018
T#03 1200 Tablets 02-2018

Trial Total no. Used Remaining

no. of tablets quantities quantities
for
stability
QA / QC DATA
12. Record of Digital data logger for temperature and Firm has submitted photocopies of data logger record for
humidity monitoring of stability chambers (real Accelerated stability chamber from 16-01-2018 to 01-09-
time and accelerated) 2018 and for Real Time stability chamber starting from 16-
01-2018 to 01-09-2018

record of testing of stability batches (i.e. Specifications and Testing Method of Voreta Tablets
chromatograms, lab reports, raw data sheets etc.) 25mg.
Real Time).
Ltd China.
excipients used in product development of Voreta 25 mg
tablets.
of our applied products ―Voreta Tablets‖ by using same
formulation (excipients) of Innovator‘s Product.
product (Voreta Tablets) with Innovator‘s Brand ―Jardiance
Tablets‖ The details are as follows:
Brand Name Jardiance Tablets 25mg
Batch No. 605049
Mfg. Date 06/2016
Exp. Date 06/2019
following media:
Decision: Registration Board decided to approve registration of ―Voreta Tablets 25 mg (Empagliflozin)‖ with
Innovator‘s specifications by M /s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.
Sr. Name & Address Brand Name Type of Form, International Availability / Local
No. of Manufacturer / (Proprietary Name + Dosage Initial Diary & Availability
Applicant Form + Strength), Date, Fee (including
Finished Product Specification Pack size
807. M /s. Scotmann Voreta Plus Tablets 12.5 Form 5D Synjardy Tablets 12.5 mg/500
Pharmaceuticals, mg/500 mg Dairy No. 42033 mg by Boehringer Ingelheim
5D, I-10/3, Each film coated tablet dated Pharmaceuticals, USFDA
Industrial Area, contains: Rs.50,000/- dated
Islamabad Empagliflozin.........12.5 mg 07-12-2018 GMP Inspection conducted on
Metformin HCl.......500 mg 10-10-2018 & 17-10-2018

Anti-Diabetic Drug, Sodium- 1x10‘s, 3x10‘s, concluded that the panel
Glucose Co-Transporter2 6x10‘s, 8x10‘s; As unanimously recommended for
(SGLT2) Inhibitor. per SRO the grant of cGMP certificate.
(Manufacturer‘s Specification)
Drug Voreta Plus Tablets 12.5 mg/500 mg
Metformin HCl: M/s Abhilasha Pharma Pvt. Ltd India
API Lot No. Empagliflozin: D5284-17-004
Metformin HCl: MET123/17
Description of Pack
Real Time: 30°C ± 2°C/65%±5% RH
Batch No. B# T-01 B# T-02 B# T-03
No. of Batches 03
No.
1. COA of API. Empagliflozin: Copy of COA (Batch#D5284-17) from
M/S Zhejiang Huahai pharmaceuticals CO; Ltd China is
submitted.
Metformin hydrochloride: Copy of COA (Batch#
MET123/17) from M/s Abhilasha Pharma Pvt. Ltd India
is submitted.
2. Approval of API by regulatory authority of country Empagliflozin: Copy of GMP Certificate (certificate
of origin or GMP certificate of API manufacturer No.ZJ20140072) issued by China Food & Drug
issued by regulatory authority of country of origin. Administration China.
Metformin hydrochloride: Copy of GMP certificate
(Certificate No. 1706138) issued by Food & Drugs
Control Administration, Gandhinagar, Gujarat state,
India for M/s Abhilasha Pharma Pvt. Ltd India.
It is valid upto 01-06-2019.
Yes

5. Documents confirming import of API etc. Empagliflozin: Copy of Form 6 (License to Import drug
for clinical trial examination, test or analysis) issued by
ADC DRAP (Islamabad) dated 14-07-2017, for the
import of Empagliflozin from M/s Zhejiang Huahai
Invoice (invoice No. HH20171596) attested by ADC
DRAP (Islamabad) dated 27-07-2017 is also submitted.
Metformin HCl: Copy of Export invoice (Invoice No.
Exp009) ) issued by ADC DRAP (Islamabad) dated 06-
09-2017, for the import of Metformin HCl from M/s
Abhilasha Pharma Pvt. Ltd India
documents.
Yes
1978.

data loggers.
2. Documents for the procurement of API with Empagliflozin: Copy of Form 6 (License to Import drug
approval from DRAP (in case of import). for clinical trial examination, test or analysis) issued by
ADC Drap (Islamabad) dated 14-07-2017, for the import of
No. HH20171596) attested by ADC Drap (Islamabad)
dated 27-07-2017 are submitted.
Exp009) ) issued by ADC DRAP (Islamabad) dated 06-09-
2017, for the import of Metformin HCl from M/s Abhilasha
Pharma Pvt. Ltd India.
4. Approval of API/ DML/GMP certificate of API Empagliflozin: The firm has submitted GMP from M/S
manufacturer issued by regulatory authority of Zhejiang Huahai pharmaceuticals CO; Ltd China is
country of origin. submitted. Issued by China Food & Drug Administration
China.

Metformin HCl: The firm has submitted GMP from M/s
Abhilasha Pharma Pvt. Ltd India issued by Food & Drugs
Control Administration, Gandhinagar, Gujarat state, India.
Procedure.
6. Certificate of analysis of the API, reference Empagliflozin: The firm has submitted
Batch No.2016-1024
Metformin HCl: The firm has submitted
COA of API Batch No. MET123/17
COA of Reference Std Batch No. RO69HO
COA of Dicyandiamide (Impurity A)
Batch No.RM083/17
product development
Production Data
stability testing of trial batches. Protocol for Lab scale batch manufacturing of Voreta Plus
Tablets 12.5 mg/500 mg.
T#01 1500 Tablets 11-2017
T#02 1500 Tablets 11-2017
T#03 1500 Tablets 11-2017


stability
QA / QC DATA
12. Record of Digital data logger for temperature and Firm has submitted copy of record of digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability chambers
time and accelerated) from Nov.2017 to June.2018.
The firm has submitted photocopy of method used for
analysis of APIs (Metformin HCl) along with COA.
record of testing of stability batches (i.e. Specifications and Testing Method of Voreta Plus Tablets
chromatograms, lab reports, raw data sheets etc.) 12.5 mg/500 mg.
Real Time).
Ltd China.
The firm has submitted copy of accelerated, 06 Months
(40°C ± 2°C & 75±5%RH) &long term, 36 Months (30°C
Metformin HCl from M/s Abhilasha Pharma Pvt. Ltd
India.
excipients used in product development of Voreta Plus
of our applied products ―Voreta Plus Tablets 12.5 mg/500
mg‖ by using same formulation (excipients) of Innovator‘s
Product.
product (Voreta Plus Tablets 12.5 mg/500 mg) with
Innovator‘s Brand ―Synjardy Tablets 12.5 mg/500 mg‖ The
details are as follows:
Brand Name Synjardy Tablets 12.5
mg/500 mg
Batch No. 857718
Exp. Date 04/2021
following media:
Decision: Registration Board decided to approve registration of ―Voreta Plus Tablets (Empagliflozin 12.5mg,
Metformin HCl 500 mg )‖ with Innovator‘s specifications by M /s. Scotmann Pharmaceuticals, 5D, I-10/3,
Industrial Area, Islamabad. Manufacturer will place first three production batches of both products on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.

Sr. Name &Address Brand Name Type of Form, International Remarks
Strength), Composition, differential fee),
Finished Product Pack size Report Date
Specification
808. M /s. Scotmann Voreta Plus Tablets Form 5D Synjardy Tablets
Pharmaceuticals, 5mg/1000mg Dairy No. 42032 5 mg/1000 mg by
5D, I-10/3, Each Film Coated Tablet Dated; 07-12-2018 Boehringer Ingelheim
Industrial Area, contains: Rs.50,000/- dated Pharmaceuticals,
Islamabad Empagliflozin……5mg 07-12-2018 USFDA
Metformin HCl...1000mg
1x10‘s, 3x10‘s, GMP Inspection
Anti-Diabetic Drug, 6x10‘s, 8x10‘s; As conducted on
Sodium-Glucose Co- per SRO 10-10-2018
Transporter2 (SGLT2) & 17-10-2018
Inhibitor concluded that the
panel unanimously
(Manufacturer‘s recommended for the
Specification) grant of cGMP
certificate.
Drug Voreta Plus Tablets 5 mg/1000 mg
Metformin HCl: M/s Abhilasha Pharma Pvt. Ltd India
API Lot No. Empagliflozin: D5284-17-004
Metformin HCl: MET123/17
Description of Pack
(Container closure Alu Alu Blister Pack
system)
Stability Storage Accelerated: 40°C ± 2°C/75%±5% RH
Condition Real Time: 30°C ± 2°C/65%±5% RH
Batch No. B# T-01 B# T-02 B# T-03
No. of Batches 03
No.
1. COA of API. Empagliflozin: Copy of COA (Batch#D5284-17) from
M/S Zhejiang Huahai pharmaceuticals CO; Ltd China is
submitted.

Metformin hydrochloride: Copy of COA (Batch#
MET123/17) from M/s Abhilasha Pharma Pvt. Ltd India
is submitted.
2. Approval of API by regulatory authority of country Empagliflozin: Copy of GMP Certificate (certificate
of origin or GMP certificate of API manufacturer No.ZJ20140072) issued by China Food & Drug
issued by regulatory authority of country of origin. Administration China.
Metformin hydrochloride: Copy of GMP certificate
(Certificate No. 1706138) issued by Food & Drugs
Control Administration, Gandhinagar, Gujarat state,
India for M/s Abhilasha Pharma Pvt. Ltd India.
Yes
5. Documents confirming import of API etc. Empagliflozin: Copy of Form 6 (License to Import drug
for clinical trial examination, test or analysis) issued by
ADC DRAP (Islamabad) dated 14-07-2017, for the
import of Empagliflozin from M/s Zhejiang Huahai
Invoice (invoice No. HH20171596) attested by ADC
DRAP (Islamabad) dated 27-07-2017 is also submitted.
Exp009) ) issued by ADC DRAP (Islamabad) dated 06-
09-2017, for the import of Metformin HCl from M/s
Abhilasha Pharma Pvt. Ltd India
documents.
Yes
1978.

data loggers.

2. Documents for the procurement of API with Empagliflozin: Copy of Form 6 (License to Import drug
approval from DRAP (in case of import). for clinical trial examination, test or analysis) issued by
ADC Drap (Islamabad) dated 14-07-2017, for the import of
No. HH20171596) attested by ADC Drap (Islamabad)
dated 27-07-2017 are submitted.
Exp009) ) issued by ADC DRAP (Islamabad) dated 06-09-
2017, for the import of Metformin HCl from M/s Abhilasha
Pharma Pvt. Ltd India.
4. Approval of API/ DML/GMP certificate of API Empagliflozin: The firm has submitted GMP from M/S
manufacturer issued by regulatory authority of Zhejiang Huahai pharmaceuticals CO; Ltd China is
country of origin. submitted. Issued by China Food & Drug Administration
China.
Metformin HCl: The firm has submitted GMP from M/s
Abhilasha Pharma Pvt. Ltd India issued by Food & Drugs
Control Administration, Gandhinagar, Gujarat state, India.
Procedure.
6. Certificate of analysis of the API, reference Empagliflozin: The firm has submitted
Batch No.2016-1024
Metformin HCl: The firm has submitted
COA of API Batch No. MET123/17
COA of Reference Std Batch No. RO69HO
COA of Dicyandiamide (Impurity A)
Batch No.RM083/17
product development
Production Data
stability testing of trial batches. Protocol for Lab scale batch manufacturing of Voreta Plus
T#01 1500 Tablets 11-2017
T#02 1500 Tablets 11-2017
T#03 1500 Tablets 11-2017


stability
QA / QC DATA
12. Record of Digital data logger for temperature and Firm has submitted copy of record of digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability chambers
time and accelerated) from Nov.2017 to June.2018.
The firm has submitted photocopy of method used for
analysis of APIs (Metformin HCl) along with COA.
record of testing of stability batches (i.e. Specifications and Testing Method of Voreta Plus Tablets
chromatograms, lab reports, raw data sheets etc.) 5mg/1000 mg.
Real Time).
Ltd China.
The firm has submitted copy of accelerated, 06 Months
(40°C ± 2°C & 75±5%RH) &long term, 36 Months (30°C
Metformin HCl from M/s Abhilasha Pharma Pvt. Ltd
India.
excipients used in product development of Voreta Plus
Tablets 5 mg/1000 mg.
of our applied products ―Voreta Plus Tablets 5mg/1000
mg‖ by using same formulation (excipients) of Innovator‘s
Product.
product (Voreta Plus Tablets 5 mg/1000 mg) with
Innovator‘s Brand ―Synjardy Tablets 5 mg/1000 mg‖ The
details are as follows:
Brand Name Synjardy Tablets
5mg/1000 mg
Batch No. 856298
Exp. Date 02/2021
following media:

been submitted for Comparative dissolution studies
Decision: Registration Board decided to approve registration of ―Voreta Plus Tablets (Empagliflozin 5mg,
Metformin HCl 1000 mg )‖ with Innovator‘s specifications by M /s. Scotmann Pharmaceuticals, 5D, I-10/3,
Industrial Area, Islamabad. Manufacturer will place first three production batches of both products on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
Applicant Dosage Form + Strength), Date, Fee (including Availability
Pharmacological Group, Demanded Price / GMP Inspection Report
Finished Product Pack size Date
Specification
809. M/s Shaigan Dacavir-60 Tablets Form 5-D DAKLINZA daclatasvir
Pharmaceuticals Dairy No. Duplicate tablets by M/s Gilead
, 14-Km, Adyala Each Film coated Tablet Dossier Sciences, Inc (USFDA
Road, Post Contains: Rs.50,000/-, approved)
Office Dahgal, Daclatasvir 22-12-2016
Rawalpindi Dihydrochloride (Duplicate) Last GMP inspection
…………....60mg was conducted on
As per SRO 14-12-2017 The
Direct Acting company is found
Antivirals complying CGMP as of
(Antivirals for today and panel
treatment of HCV unanimously agreed to
infections) issue CGMP certificate
for export along with
Manufacturer‘s COPP, The management
Specifications. was advised to continue
the process of up
gradation.
Drug Dacavir 60 Tablets
Name of Manufacturer M/s Shaigan Pharmaceuticals, 14-Km, Adyala Road, Post Office Dahgal,
Rawalpindi
Manufacturer of API Ruyuan HEC Pharma Co .Ltd China
API Lot No. DSV-RD201602201R1
Description of Pack Alu-Alu Blister of 4x7‘s. Pack
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 0,1,2,3,4,6,8,12,16,20,24,26 weeks
Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 weeks
Frequency Accelerated: 26 (weeks) Real Time: 26 (weeks)
Batch No. T-001 T-001 T-001
th
No. of Batches 03
1. COA of API. Copy of COA (Batch# DSV-RD201602201R1) from
Ruyuan HEC Pharma Co .Ltd China, is submitted.
2. Approval of API by regulatory authority of country Copy of GMP Certificate issued by Shaoguan Food
of origin or GMP certificate of API manufacturer and Drug Administration Peoples Republic of China
issued by regulatory authority of country of origin. (Certificate #2018004), has been submitted with
validity till 05-03-2019.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice
for the import of 700g of Daclatasvir
(Invoice#W20160216PK0103) attested by ADC
DRAP, Islamabad dated 13-05-2016.
documents.
Yes
1978.

1. Reference of last onsite panel inspection The firm has submitted reference of already approved
for instant dosage form conducted during product in 285th meeting the decision as:
last two years. Registration Board decided to approve registration of Vebuvir
Tablets 400 mg (Sofosbuvir) of M/s Shaigan Pharmaceuticals (Pvt)
Ltd, 14 km, Adyala road, post Office Dahgal, Rawalpindi.
Manufacturer will place first three production batches of both
products on long term stability studies throughout proposed shelf
Date of inspection: 8th August, 2018
The HPLC software of the firm is 21 CRF compliant.
The firm has provided USB data loggers, which are set for
recording temperature and humidity after each hour.
2. Documents for the procurement of API The firm has submitted copy of commercial invoice for the import
with approval from DRAP (in case of of 700g of Daclatasvir (Invoice#W20160216PK0103) attested by
import). ADC DRAP, Islamabad dated 13-05-2016.

3. Documents for the procurement of Firm has stated that Reference standards and impurity standard
reference standard and impurity were supplied free of cost therefore Import Documents are
standards. unavailable, whereas COA of both are submitted.
4. Approval of API/ DML/GMP certificate Copy of GMP Certificate issued by Shaoguan Food and Drug
of API manufacturer issued by regulatory Administration Peoples Republic of China (Certificate #2018004),
authority of country of origin. has been submitted with validity till 05-03-2019.
5. Mechanism for Vendor pre-qualification The firm has submitted Mechanism for Vendor prequalification.
6. Certificate of analysis of the API,  Copy of COA of Daclatasvir ((Batch# DSV-RD201602201R1)
reference standards and impurity from Ruyuan HEC Pharma Co .Ltd China, is submitted.
standards  Copy of COA of working standards Batch# PRS-15048 have been
Submitted
 COAs of impurity standards have been submitted.
Impurity A (Batch# PRS-16043)
Impurity B (Batch# PRS-16044)
Impurity C (Batch# PRS-16022)
7. Documents for the procurement of The firm has submitted photocopy of Commercial invoices/COAs
excipients used in product development? of the excipients used in the formulation of applied product
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in product
development with relevant experience. development department.
Production Data
9. Authorized Protocols/ SOP for the
The firm has submitted photocopy of ―Protocols/SOP for the
development & stability testing of trial
Development of ―Dacavir 60 Tablets.
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing Records
three stability batches. of following 03 Batches:
T-001 1000 Tablets 03-2017
T-002 1000 Tablets 03-2017
T-003 1000 Tablets 03-2017
11. Record of remaining quantities of Trial No Total no. Of Tablets Tablets used Remaining
stability batches. For stability testing for testing Qty of tablets
T-001 868 230
T-002 870 638 232
T-003 863 225
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of digital data logger record for
temperature and humidity monitoring of Accelerated stability chamber from 20-03-2017 to 11-10-2017 and
stability chambers (real time and Real Time stability chamber starting from 24-03-2017 to 02-10-
accelerated) 2017.
13. Method used for analysis of API along The firm has submitted photocopy of Raw Material Specifications,
with COA. Raw Material Testing Procedures along with COA for Daclatasvir.
14. Method used for analysis of FPP &
The firm has submitted photocopy of Finished Product Testing
complete record of testing of stability
Procedure for ―Dacavir-60 Tablets‖ along with Stability Study
batches (i.e. chromatograms, lab reports,
Reports.
raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months Accelerated
manufacturer. (40°C±2°C/75%±5%RH) and 36 Months Real Time
(30°C±2°C/65%±5%RH) Stability Study Data of 03 Batches for
Daclatasvir from Ruyuan HEC Pharma Co .Ltd China.
16. Analysis reports for excipients used. The firm has submitted photocopy Analytical reports of excipients
used.
17. Drug-excipients compatibility studies. The firm has submitted that ingredients of Dacavir-60 Tablets and
Daklinza 600mg Tablet (innovator brand) are same.
18. Record of comparative dissolution data.The firm has performed comparative dissolution studies with
Mydekla 60mg Tablets manufactured by M/s. Mylan Labs, India
(Batch#8067665, EXP 04/19) using Phosphate buffer pH 6.8 with
0.7% Brij 35. The firm‘s product (Dacavir 60 Tablets) results are
comparable with MYDEKLA 60mg Tablets.
19. Compliance Record of HPLC software The firm has submitted audit trail reports of Dacavir-60 Tablets
21CFR & audit trail reports on product from 13-04-2017 to 28-09-2018.
testing.
Decision: Registration Board decided to approve registration of ―Dacavir-60 Tablets (Daclatasvir
Dihydrochloride)‖ with Innovator‘s specifications by M/s Shaigan Pharmaceuticals , 14-Km, Adyala Road,
Post Office Dahgal,Rawalpindi. Manufacturer will place first three production batches of both products on
long term stability studies throughout proposed shelf life and on accelerated studies for six months.
810. Name and address of manufacturer / M/s Sami Pharmaceuticals (Pvt.) Limited. F-95 S.I.T.E. Karachi.
Applicant
Brand Name +Dosage Form + Strength SILOS 4mg Capsules
Composition Each capsules contains:
Silodosin MS…….….4mg
Diary No. Date of R& I & fee Dy NO.113921; 05-03-2019: 50,000/- (04-03-2019)
Pharmacological Group Antiadrenergic agent
Finished product Specification Innovator‘s Specification
Pack size & Demanded Price 10‘s: RS; 600-/10‘s
Regulatory Authorities. (RAPAFLO Capsules of ALLERGAN SALES LLC)
Me-too status N/A
GMP status GMP certificate issued dated: 14-06-2018
Drug SILOS 4mg Capsules
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt.) Limited. F-95 S.I.T.E. Karachi.
Manufacturer of API M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd. China
API Lot No. Lot#: 13000-171203-02-1 , Quantity; 1kg
Stability Storage Condition Accelerated:40°C ± 2°C/75%±5% RH Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (Months) Real Time: 6 (Months)
Frequency Accelerated: 0,1,2,3,4,6 (Months) Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. Lab#01 Lab#02 Lab#03
Batch Size 4000 Capsules 4000 Capsules 4000 Capsules
Date of Initiation June 2018 June 2018 June 2018
No. of Batches 03
1. COA of API. Copy of COA (Batch#13000-171203-02-1) from M/S
Zhejiang Tianyu Pharmaceuticals Co., Ltd. China is
submitted.
2. Approval of API by regulatory authority of
Copy of GMP (certificate no. MI-2016-CE-
country of origin or GMP certificate of API
06202-1) has been submitted for M/s. Zhejiang Tianyu
manufacturer issued by regulatory authority of
Pharmaceuticals Co., Ltd. China approved by TGA,
country of origin
Austraila .Valid till 15-03-2021

study and details of tests. Yes

5. Documents confirming import of API etc. Copy of Form 6 License to Import drug for clinical trial
examination, test or analysis) issued by ADC (Karachi)
dated 12-02-2018, for the import of Silodosin API from
M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd. China;
has been submitted.
Copy of Commercial invoice No. TYI18106 attested by
ADC (Karachi) dated 12-02-2018 has been submitted
sign and stamp) for ensuring authenticity of data Yes
/ documents.
Yes
Yes
Rules, 1978.
REMARKS OF EVALUATORS
The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale Batches.
ADMINISTRATION PORTION
Firm has referred last onsite panel inspection for instant
dosage form conducted during last two years- DELANZO DR
(Dexlansoprazole) 30mg & 60mg Capsules on 02nd April,
2018, by following panel:
1. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy,
Jinnah University for Woman, 5-C, St-1, Nazimabad,
Karachi
Reference of last onsite panel inspection for 2. Dr. Saif-Ur-Rehman Khattak, Director / FGA, CDL,
1. instant dosage form conducted during last DRAP, Karachi.
two years. 3. Dr. Mehwish Tanveer, Assistant Director, DRAP Office,
Karachi.
data loggers
Copy of Form 6 License to Import drug for clinical trial
examination, test or analysis) issued by ADC (Karachi) dated
12-02-2018, for the import of Silodosin API from M/s.
Documents for the procurement of API with
2. Zhejiang Tianyu Pharmaceuticals Co., Ltd. China; has been
approval from DRAP (in case of import).
submitted.
Copy of Commercial invoice No. TYI18106 attested by ADC
(Karachi) dated 12-02-2018 has been submitted
Documents for the procurement of reference Impurity and working standards were also dispatched with
3.
standard and impurity standards. API
Approval of API/ DML/GMP certificate of Copy of GMP (certificate no. MI-2016-CE-06202-1) has been
4. API manufacturer issued by regulatory submitted for M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd.
authority of country of origin. China approved by TGA, Austraila .Valid till 15, March 2021

The firm has submitted Work instruction for Evaluation of
5. Mechanism for Vendor pre-qualification
Suppliers and vendors.
 Copies of COAs of Silodosin (Batch No.#13000-171203-
02-1) from M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd.
China.
 Copy of COA of working standards Batch# WRS161201 &
Certificate of analysis of the API, reference Batch# WRS160701 have been submitted.
6.
standards and impurity standards  COAs of impurity standards have been submitted.
YDL Impurity 1 Batch No # IRS160901
YDL Impurity 4 Batch No # WRS160701
The firm has submitted commercial invoices & COAs of all
Documents for the procurement of excipients
7. the excipients used in formulation of SILOS 4mg Capsules,
from relevant manufacturers
List of qualified staff involved in product The firm has submitted copy of List of qualified staff their
8.
Production Data
Authorized Protocols/SOP for the The firm has submitted photocopy of SOP for development of
9. development & stability testing of trial SILOS 4mg Capsules Stability protocol.
batches.
The firm has submitted copy of Batch manufacturing Record
of the following 3 batches Three stability batches:
Complete batch manufacturing record of Batch No. Batch Size Mfg. Date
10.
three stability batches. Lab-01 4000 Capsules May 2018
Lab-02 4000 Capsules May 2018
The firm has submitted reconciliation sheet mentioning
remaining quantity of three trial batches.
Record of remaining quantities of stability
11. Trial Total No. of Capsules Used Remaining
batches.
no. for stability quantities quantities
01 2980 416 2564
02 2980 416 2564
03 2980 416 2564
QA/QC Data
Record of Digital data logger for temperature The firm has submitted photocopies of digital printouts for
12. and humidity monitoring of stability Real Time and Accelerated Conditions for complete stability
chambers (real time and accelerated) Studies of applied formulations.
The firm has supplier‘s method for analysis of API and has
Method used for analysis of API along with
13. submitted analytical reports, raw data sheets & relevant
COA.
chromatograms.
The firm has submitted photocopy of Finished Product
Method used for analysis of FPP & complete
specification & Test method along with analytical method
record of testing of stability batches (i.e.
14. validation report.
chromatograms, lab reports, raw data sheets
Firm has submitted complete record of testing of stability
etc.)
batches (i.e. chromatograms, lab reports, raw data sheets etc.)
Accelerated(40°C ± 2°C & 75±5%RH) and 12 Months Real
Reports of stability studies of API from
15. Time Stability Study (30°C ± 2°C & 65±5%RH) Data of 03
manufacturer.
Batches of API M/s. Zhejiang Tianyu Pharmaceuticals Co.,
Ltd. China

The firm has submitted copies of its own Analytical reports
16. Analysis reports for excipients used. for all excipients used in product development of SILOS 4mg
Capsules
The firm has submitted Compatibility study report (dated 5-6-
2018) along with raw data sheets and relevant chromatograms.
It is pertinent to mention here that compatibility studies have
been performed after the initiation of stability studies
Firm has submitted Comparative Dissolution Profile protocol
& reports. The details of reference product & Sample product
are as follows:
Reference Product of M/s
Feature
Product SAMI
18. Record of comparative dissolution data
Brand Name RAPAFLO SILOS Capsules
Batch No. 1132872A LAB-01
Exp. Date Feb-2019 26-05-2018
Firm have comparable dissolution profile with the reference
product
Compliance Record of HPLC software Firm has submitted audit trail reports for complete stability
19. 21CFR & audit trail reports on product studies analysis of three batches.
testing.
Decision: Registration Board decided to approve registration of ―SILOS 4mg Capsules (Silodosin)‖ with
Innovator‘s specifications by M/s Sami Pharmaceuticals (Pvt.) Limited. F-95 S.I.T.E. Karachi. Manufacturer
will place first three production batches of both products on long term stability studies throughout proposed
Applicant
Brand Name +Dosage Form + Strength SILOS 8mg Capsules
Composition Each capsules contains:
Silodosin MS…….….8mg
Diary No. Date of R& I & fee Dy No.11392; 05-03-2019: 50,000/- (04-03-2019)
Pharmacological Group Antiadrenergic agent
Pack size & Demanded Price 10‘s; Rs: 1000/10‘s
Regulatory Authorities. (RAPAFLO Capsules of ALLERGAN SALES LLC)
Me-too status N/A
GMP status GMP certificate issued dated: 14-06-2018
Drug SILOS 8mg Capsules
Manufacturer of API M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd. China
API Lot No. Lot#: 13000-171203-02-1 , Quantity; 1kg
Stability Storage Condition Accelerated:40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (Months)
Real Time: 6 (Months)
Frequency Accelerated: 0,1,2,3,4,6 (Months)
Real Time: 0,3,6,9,12,18,24 (Months)
Batch Size 3000 Capsules 3000 Capsules 3000 Capsules
Date of Initiation June 2018 June 2018 June 2018

No. of Batches 03
Date of Submission (11392) 05-03-2019
1. COA of API. Copy of COA (Batch#13000-171203-02-1) from M/S
Zhejiang Tianyu Pharmaceuticals Co., Ltd. China is
submitted.
Copy of GMP (certificate no. MI-2016-CE-
06202-1) has been submitted for M/s. Zhejiang Tianyu
Pharmaceuticals Co., Ltd. China approved by TGA,
country of origin
Austraila .Valid till 15-03-2021
Yes
5. Documents confirming import of API etc. Copy of Form 6 License to Import drug for clinical trial
examination, test or analysis) issued by ADC (Karachi)
dated 12-02-2018, for the import of Silodosin API
from M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd.
China; has been submitted.
Copy of Commercial invoice No. TYI18106 attested by
ADC (Karachi) dated 12-02-2018 has been submitted
documents.
Yes
Yes
1978.
Administration portion
Firm has referred last onsite panel inspection for instant
dosage form conducted during last two years- DELANZO DR
(Dexlansoprazole) 30mg & 60mg Capsules on 02nd April,
2018, by following panel:
1. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy,
Jinnah University for Woman, 5-C, St-1, Nazimabad,
Karachi
Reference of last onsite panel inspection for 2. Dr. Saif-Ur-Rehman Khattak, Director / FGA, CDL,
1. instant dosage form conducted during last DRAP, Karachi.
two years. 3. Dr. Mehwish Tanveer, Assistant Director, DRAP Office,
Karachi.
data loggers

12-02-2018, for the import of Silodosin API from M/s.
Documents for the procurement of API with
2. Zhejiang Tianyu Pharmaceuticals Co., Ltd. China; has been
approval from DRAP (in case of import).
submitted
Copy of Commercial invoice No. TYI18106 attested by ADC
(Karachi) dated 12-02-2018 has been submitted
Documents for the procurement of reference Impurity and working standards were also dispatched with
3.
standard and impurity standards. API
Approval of API/ DML/GMP certificate of Copy of GMP (certificate no. MI-2016-CE-06202-1) has been
4. API manufacturer issued by regulatory submitted for M/s. Zhejiang Tianyu Pharmaceuticals Co., Ltd.
authority of country of origin. China approved by TGA, Austraila .Valid till 15, March 2021
 Copies of COAs of Silodosin (Batch No.#13000-171203-
02-1) from M/s. Zhejiang Tianyu Pharmaceuticals Co.,
Ltd. China.
 Copy of COA of working standards Batch# WRS161201
Certificate of analysis of the API, reference & Batch# WRS160701 have been submitted.
6.
standards and impurity standards  COAs of impurity standards have been submitted.
YDL Impurity 4 Batch No # WRS160701
7. the excipients used in formulation of SILOS 8mg Capsules,
from relevant manufacturers
8.
development with relevant experience. involved in product development.
Production Data
Authorized Protocols/SOP for development The firm has submitted photocopy of SOP for development of
9.
& stability testing of trial batches. SILOS 8mg Capsules Stability protocol.
10.
three stability batches. Lab-01 3000 Capsules May 2018
Record of remaining quantities of stability Tria Total no. of Used Remaining

11.
batches. l no. Capsules for quantities quantities
stability
01 2514 336 2178
02 2514 336 2178
03 2514 336 2178
QA/QC Data

The firm has supplier‘s method for analysis of API and has
13. submitted analytical reports, raw data sheets & relevant
COA.
chromatograms.
etc.)
Accelerated(40°C ± 2°C & 75±5%RH) and 12 Months
15. Real Time Stability Study (30°C ± 2°C & 65±5%RH) Data
manufacturer.
of 03 Batches of API M/s. Zhejiang Tianyu Pharmaceuticals
Co., Ltd. China
The firm has submitted copies of its own Analytical reports
16. Analysis reports for excipients used. for all excipients used in product development of SILOS 8mg
Capsules
The firm has submitted Compatibility study report (dated 07-
12-2018) along with raw data sheets and relevant
chromatograms.
It is pertinent to mention here that compatibility
studies have been performed after the initiation of
stability studies
are as follows:
Reference Product of
Feature
Product M/s SAMI
18. Record of comparative dissolution data SILOS
Brand Name RAPAFLO
Capsules
Batch No. 1145668M LAB-01
Exp. Date Feb-2019 26-05-2018
Firm have comparable dissolution profile with the reference
product .
testing.
Decision:Registration Board decided to approve registration of ―SILOS 8mg Capsules (Silodosin)‖ with
Innovator‘s specifications by M/s Sami Pharmaceuticals (Pvt.) Limited. F-95 S.I.T.E. Karachi. Manufacturer
will place first three production batches of both products on long term stability studies throughout proposed
Applicant
Brand Name +Dosage Form + Strength IBURO 400mg/100ml Infusion
Ibuprofen BP ………400mg
Diary No. Date of R& I & fee Dy No.15669; 07-03-2019: 50,000/- (04-03-2019)
Approval status of product in Reference Ibuprofen 600mg/100ml Infusion of MHRA approved
Me-too status N/A
GMP status The last GMP inspection conducted on 07-02-2018 & 14-02-2019
and report concludes that firm was considered to be operating at
good compliance with GMP.
Remarks of the Evaluator Both SVP and LVP sections are present.
Drug IBURO 400mg/100ml Infusion
API Lot No. Lot#: 4050-3159 , Quantity; 5 kg
Description of Pack Glass bottle USP Type – II
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 0,3,6,9,12,18,24 (Months)
Batch Size 15 L 15 L 15 L
Date of Initiation July 2018 July 2018 July 2018
No. of Batches 03
Date of Submission
1. COA of API. Copy of COA (Batch#4050-3159) from M/S SI Group
,Orangeburg, SC, USA is submitted
SI Group, Inc. ,725 Cannon Bridge Road,
Orangeburg, South Carolina (SC) 29115, United States
(USA)
country of origin
Yes
Invoice No:442831
Ibuprofen 40 Microns
ADC Attested Invoice dated: 09-10-2017
Quantity: 5 Kg
documents.
Yes
Yes
1978.
Reference of last onsite panel inspection for  Firm has referred last onsite panel inspection for instant
1.
instant dosage form conducted during last dosage form conducted during last two years IBURO
two years. (Ibuprofen) 800mg/8ml Injection on 28th January, 2019
by following panel:
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Member
Registration Board
3. Mr. Affan Ali Qureshi, Assistant Director (CDL),
DRAP, Karachi.
09-10-2017, for the import of Ibuprofen from M/s. SI Group,
Documents for the procurement of API with Inc., 725 Cannon Bridge Road, Orangeburg, South Carolina
2.
approval from DRAP (in case of import). (SC) 29115, United States (USA)
Copy of Commercial invoice No. 442831 dated 05-09-
2017 attested by ADC (Karachi) dated 09-10-2017 has been
submitted .
Documents for the procurement of reference Firm has submitted pro forma of Working /reference standard
3.
standard and impurity standards. from EDQM.
Approval of API/ DML/GMP certificate of SI Group, Inc., 725 Cannon Bridge Road, Orangeburg, South
4. API manufacturer issued by regulatory Carolina (SC) 29115, United States (USA) Registration of
authority of country of origin. Establishment No. 3011012288
Certificate of analysis of the API, reference The firm has Certificate of Analysis for API, working
6.
standards and impurity standards standards and impurity standard.
7. the excipients used in formulation of IBURO 400mg/100ml
Infusion, from relevant manufacturers
8.
Production Data
9.
& stability testing of trial batches. IBURO 400mg/100ml Infusion Stability protocol.
10.
three stability batches. Lab-01 15 L July 2018
Lab-02 15 L July 2018
Lab-03 15 L July 2018
Record of remaining quantities of stability Trial Total no. of Used Remaining

11.
batches. no. Bottles for quantities quantities
stability
01 91 30 61
02 91 30 61
03 91 30 61
QA/QC Data

The firm has applied supplier‘s method for analysis of API and
13. has submitted analytical reports, raw data sheets & relevant
COA.
chromatograms.

etc.)
15. Accelerated and Real Time Stability Study Data of 03 Batches
manufacturer.
of API M/s. SI Group, Inc.
The firm has submitted copies of its own Analytical reports for
16. Analysis reports for excipients used. all excipients used in product development of IBURO
400mg/100ml Infusion
17. Drug-excipients compatibility studies. 06-2018) along with raw data sheets and relevant
chromatograms.
are as follows:
Feature
18. Record of comparative dissolution data Product M/s SAMI
Ibuprofen Ibuprofen
Brand Name
Infusion Infusion
Batch No. 18301406 LAB-01
Exp. Date June - 2020 -
testing.
 Justify the quantity of API i.e. 402.857/vial The quantity of API as per label claim is 400mg/100ml
used in the formulation as the label claim is whereas the calculated quantity of API is 402.857mg/100ml
400mg/100ml. which is according to its potency. However, the quantity of
API per 100ml will remain same as of label claim.
Decision: Registration Board decided to approve registration of ―IBURO 400mg/100ml Infusion (Ibuprofen)‖
with Innovator‘s specifications by M/s Sami Pharmaceuticals (Pvt.) Limited. F-95 S.I.T.E. Karachi.
Applicant
Brand Name +Dosage Form + Strength IBURO 600mg/100ml Infusion
Ibuprofen BP ………600mg
Diary No. Date of R& I & fee Dy N.15670;07-03-2019: 50,000/- (04-03-2019)
Pack size & Demanded Price 100ml : As per SRO
Approval status of product in Ibuprofen 600mg/100ml Infusion of MHRA approved
Me-too status N/A
GMP status The last GMP inspection conducted on 07-02-2018 & 14-02-2019
and report concludes that firm was considered to be operating at good

compliance with GMP.
Remarks of the Evaluator Both SVP and LVP sections are present.
Drug IBURO 600mg/100ml Infusion
API Lot No. Lot#: 4050-3159 , Quantity; 5 kg
Description of Pack Glass bottle USP Type – II
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 0,3,6,9,12,18,24 (Months)
Batch Size 15 L 15 L 15 L
Date of Initiation July 2018 July 2018 July 2018
No. of Batches 03
Date of Submission
1. COA of API. Copy of COA (Batch#4050-3159) from M/S SI Group
,Orangeburg, SC, USA is submitted
SI Group, Inc. ,725 Cannon Bridge Road,
Orangeburg, South Carolina (SC) 29115, United States
(USA)
country of origin
Yes
5. Documents confirming import of API etc. Copy of Commercial invoice No. 442831 dated 05-09-
2017 attested by ADC (Karachi) dated 09-10-2017 has
been submitted.
documents.
Yes
Yes
1978.
 Firm has referred last onsite panel inspection for instant
dosage form conducted during last two years IBURO
Reference of last onsite panel inspection for
(Ibuprofen) 800mg/8ml Injection on 28th January, 2019
1. instant dosage form conducted during last
by following panel:
two years.
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Member
Registration Board
3. Mr. Affan Ali Qureshi, Assistant Director (CDL),
DRAP, Karachi.
09-10-2017, for the import of Ibuprofen from M/s. SI Group,
Documents for the procurement of API with Inc., 725 Cannon Bridge Road, Orangeburg, South Carolina
2.
approval from DRAP (in case of import). (SC) 29115, United States (USA)
Copy of Commercial invoice No. 442831 dated 05-09-2017
attested by ADC (Karachi) dated 09-10-2017 has been
submitted .
Documents for the procurement of reference Firm has submitted pro forma of Working /reference standard
3.
standard and impurity standards. from EDQM.
Approval of API/ DML/GMP certificate of SI Group, Inc., 725 Cannon Bridge Road, Orangeburg, South
4. API manufacturer issued by regulatory Carolina (SC) 29115, United States (USA) Registration of
authority of country of origin. Establishment No. 3011012288
Certificate of analysis of the API, reference The firm has Certificate of Analysis for API, working
6.
standards and impurity standards standards and impurity standard.
7. the excipients used in formulation of IBURO 600mg/100ml
Infusion, from relevant manufacturers
8.
Production Data
9.
& stability testing of trial batches. IBURO 600mg/100ml Infusion Stability protocol.
10.
three stability batches. Lab-01 15 L June 2018
Lab-02 15 L June 2018
Lab-03 15 L June 2018
Record of remaining quantities of stability Trial Total no. of Used Remaining

11.
batches. no. Bottles for quantities quantities
stability
01 91 30 61
02 91 30 61
03 91 30 61
QA/QC Data
The firm has applied supplier‘s method for analysis of API and
13. has submitted analytical reports, raw data sheets & relevant
COA.
chromatograms.
Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. specification & Test method along with analytical method
14.
chromatograms, lab reports, raw data sheets validation report.
etc.) Firm has submitted complete record of testing of stability

15. Accelerated and Real Time Stability Study Data of 03 Batches
manufacturer.
of API M/s. SI Group, Inc.
The firm has submitted copies of its own Analytical reports for
16. Analysis reports for excipients used. all excipients used in product development of IBURO
600mg/100ml Infusion
17. Drug-excipients compatibility studies. 06-2018) along with raw data sheets and relevant
chromatograms.
Firm has submitted Comparative analysis reports. The details
of reference product & Sample product are as follows:
Feature
18. Record of comparative dissolution data Product M/s SAMI
Ibuprofen Ibuprofen
Brand Name
Infusion Infusion
Batch No. 18301411 LAB-01
Exp. Date June - 2020 -
testing.
The quantity of API as per label claim is 600mg/100ml
 Justify the quantity of API i.e. 605.285/vial
whereas the calculated quantity of API is 604.285mg/100ml
used in the formulation as the label claim is
which is according to its potency. However, the quantity of
600mg/100ml.
API per 100ml will remain same as of label claim.
Decision: Registration Board decided to approve registration of ―IBURO 600mg/100ml Infusion (Ibuprofen)‖
with Innovator‘s specifications by M/s Sami Pharmaceuticals (Pvt.) Limited. F-95 S.I.T.E. Karachi.
814. Name and address of manufacturer / M/s Werrick pharmaceuticals, 216-217, I-10/3, Industrial
Applicant Area, Islamabad.
Brand Name +Dosage Form + Strength Deflazot Tablets 6mg
Composition Each Compressed tablets contains:
Deflazacort .........6mg
Diary No. Date of R& I & fee Dy. No.16554 dated : 07-03-2019 Rs.20,000/- 07-03-2019
Pharmacological Group Corticosteroids
Type of Form Form – 5
Pack size & Demanded Price 20's, 30's, ; As per SRO
Approval status of product in Approved in US-FDA (EMFLAZA Tablet 6mg )
Me-too status (with strength and CALCORT TABLETS 6mg of M/s HOECHST KARACHI
dosage form) (Reg No# 025224)
GMP status GMP Inspection conducted on 09-11-2018 with conclusive remarks
that firm is operating at satisfactory level of GMP compliance.
Drug Deflazot Tablets 6mg
Name of Manufacturer M/s Werrick pharmaceuticals, 216-217, I-10/3, Industrial Area, Islamabad.

Manufacturer of API M/s Anuh Pharma Ltd.
API Lot No. APL/191/1-17 (Deflazacort)
Description of Pack Alu -Alu Blister Pack in Unit carton
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 9 Months
Frequency Real Time: 0,3,6 & 9 (months)
Batch No. Trial# 01 Trial# 02 Trial# 03
No. of Batches 03
#
1. COA of API. Copy of COA (batch # APL/191/1-17) from M/s Anuh
Pharma Ltd. India
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate No.6080699) issued by
country of origin or GMP certificate of API Food & Drugs Administration Konkan Division, Maharashtra
manufacturer issued by regulatory authority of State. It is valid until 21/03/2019.
country of origin.
3. Protocols followed for conduction of
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice No;
EXP/276/2018 dated 20-12-2017 (Deflazacort) attested by
ADC, DRAP, Islamabad dated; 18-01-2018
sign and stamp) for ensuring authenticity of data
/ documents.
Yes
Rules, 1978.
The firm has submitted 26 Weeks Accelerated and 38 Weeks Real Time Stability Data for 03 Batches.
following documents in conjunction with the checklist approved by the Registration Board in its 278 th Meeting
instant dosage form conducted during last product ―Cell-Tab 400mg (Sofosbuvir) Tablets‖, which was
two years. presented Initially in 256th subsequently in 269th&finally in 276th
meeting of Registration board.
above stated drug product of M/s. Werrick
Pharmaceuticals. According to the report following
points were confirmed.
 The firm has 21CFR compliant HPLC software.
2. Documents for the procurement of API with The firm has submitted copy of commercial invoice No;
approval from DRAP (in case of import). EXP/276/2018 dated 20-12-2017 (Deflazacort) attested by ADC,
DRAP, Islamabad dated; 18-01-2018.
3. Documents for the procurement of reference The firm has submitted copies of COA for following working
standard and impurity standards. standard:
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate declaring
API manufacturer issued by regulatory following information:
authority of country of origin. Certificate No.6080699 Issued to: M/s Anuh Pharma Ltd, India.
Issued by: Food & Drug Administration, Konkan Division,
Maharashtra State. Validity: Valid Till 21-03-2019.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API, reference Applicant has submitted following COAs:
standards and impurity standards  Copy of COA of API (batch # APL/191/1-17) from M/s
Anuh Pharma Ltd. India has been submitted.
 Copy of COA of reference standard of Deflazacort (batch
# APL/150/G-17) has been submitted.
7. Documents for the procurement of The firm has submitted photocopy of Commercial
excipients used in product development? invoices/COAs of all the excipients used in the
formulation of applied product.
 Commercial invoice dated 26-09-17 for Corn Starch.
 Commercial invoice dated 10-11-17 for Lactose.
 Commercial invoice dated 25-09-17 for Aerosil.
 Commercial invoice dated 03-11-16 for Magnesium Stearate
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in R&D
development with relevant experience. department.
Production Data
9. Authorized Protocols/SOP for the evelopment The firm has submitted photocopy of ―Protocols/SOP
& stability testing of trial batches. for the Development of Deflazot Tablets 6mg
Mfg. Date
Batch No. Batch Size
Trial # 01 1500 tablets Mar-18


stability
Trial # 1190 Tab 320 Tab 880 Tab
01 (60 packs * (16 packs * (44 packs *
20‘s) 20‘s) 20‘s)
02 (58 packs * (15 packs * (43 packs
20‘s) 20‘s) *20‘s)
03 (58 packs * (15 packs * (43 packs
20‘s) 20‘s) *20‘s)
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger record for
and humidity monitoring of stability chambers used in Real Time & Accelerated stability studies
chambers (real time and accelerated) of applied product from 01-05-2018 to 13-02- 2019.
13. Method used for analysis of API along with The firm has submitted photocopies of following:
COA. Raw Material Test/Analysis Procedures & Raw Material
Specifications Of Deflazacort (in house) .
14. Method used for analysis of FPP & complete The firm has submitted photocopies of following:
record of testing of stability batches (i.e. FPP Test/Analysis Method & FPP Specifications (In-house)
chromatograms, lab reports, raw data sheets etc.) for Deflazot Tablets 6mg.
manufacturer. and 36 Months Real Time Stability Study Data of 03 Batches
of Deflazacort from M/s Anuh Pharma Ltd, India according
to zone IVA conditions.
16. Analysis reports for excipients used. The firm has submitted copy of Analytical reports of
excipients used.
17. Drug-excipients compatibility studies. The firm has used the excipients of innovator.
18. Record of comparative dissolution data. Exemption Claimed as the reference product is not available
in Pakistan.
19. Compliance Record of HPLC software 21CFR & Audit trail on testing reports of Deflazacort from 28-03-2018
audit trail reports on product testing. to 7-02-2019 was submitted by the firm.
 Record of comparative dissolution datanot provided according to firmExemption Claimed as the reference
product is not available in Pakistan.
Sr. Deficiencies/Shortcomings Reply by Firm
#
1. In T# 01final mixing of powder was done In Trial # 01 final mixing of granules was done on 12-03-2018,
on (12-03-2018) and compression was and in process analysis carried out on 28-03-2018, then trial was
done on 25-04-2018 .Justify. compressed into two steps. Initially small amount of granules
were compressed on 31-03-2018. After its analysis on 23-04-
2018 (compressed tablets) the remaining granules were
compressed on 25-04-2018. Granules were stored/kept in sealed
bag and well closed container during the process Evidence
weight variation sheet (attached)
2. In all 3 batches approval for blistering The Initial compression of the batches was done on 31-03-2018
was 23-04-2018 while compression done after which the compressed tablet were analysed on 23-04-2018
on 25- and approval for the blistering for initially compressed tablets
04-2018. Justify. was given. However, the remaining granules were compressed
on 23-04-2018 and the process of blistering was carried out on
30-04-2018. In this way the trial got compressed in two steps.
The whole trial was not initially compressed due to limited
quantity of API and once the initially compressed tablets were
passed the remaining trial got compressed.
3. In all 3 batches compression was As the compression of tablets done in two steps, the analytical
done on 25-04-2018 while some tests like D.Time, Friability etc., for initially compressed tablet
analytical test were performed on 31-03- was carried out on 31-03-2018 on the date of initial compression
2018 as per submitted batch and remaining granules were compressed on 25-04-2018 as
manufacturing record. Justify evident from weight variation sheet.
4. In T# 02 & T# 03 final mixing of powder In T# 02 and T# 03 final mixing of granules was done on 28-03-
was done on (23-03-2018) and 2018. Initially some granules were compressed on 31-03-2018
compression done on and once passed through analysis on23-04-2018 the remaining
25-04-2018 .Justify trial got compressed on 25-04-2018as evident from weight
variation sheet.
5. In T# 01, 3rd month for Real time Typographical error in raw data sheet. Corrected raw data sheets
stability assay chromatograms not attached.
matching raw data sheets. Justify
6. In Batch No T # 02, 6th month for Real Typographical error in raw data sheet. Corrected raw data sheets
time stability dissolution chromatograms attached.
not matching raw data sheets. Justify.
Decision: Registration Board deferred for onsite verification of stability studies.
Diary No. Date of R& I & fee Dy. No.16555 dated : 07-03-2019 Rs.50000/- 07-03-2019
Type of Form Form – 5 D
Pack size & Demanded Price 10‘s, 20's, 30's, ; As per SRO
Me-too status (with strength and Nil
dosage form)
Real Time: 30°C ± 2°C / 65% ± 5%RH
Frequency Real Time: 0,3,6 & 9 (months) Accelerated: 0,1,2,3,4 & 6 (months)

No. of Batches 03
No.
Pharma Ltd. India
country of origin.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice No.EXP/
276 /2018 dated 20-12-2017 (Deflazacort) attested by ADC,
DRAP, Islamabad dated; 18-01-2018
/ documents.
Yes
Rules, 1978.
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product ―Cell-Tab
inspection for instant dosage form 400mg (Sofosbuvir) Tablets‖, which was presented Initially in 256th
conducted during last two subsequently in 269th&finally in 276th meeting of Registration board.
years. Registration Board decided to approve registration of above stated drug
product of M/s. Werrick Pharmaceuticals. According to the report
following points were confirmed.
2. Documents for the procurement of The firm has submitted copy of commercial invoice No; EXP/276/2018
API with approval from DRAP (in dated 20-12-2017 (Deflazacort) attested by ADC, DRAP, Islamabad dated;
case of import). 18-01-2018.
3. Documents for the procurement of The firm has submitted copies of COA for following working standard :
reference standard and impurity

standards.
4. Approval of API/ DML/GMP The firm has submitted copy of GMP certificate declaring following
certificate of API manufacturer information:
issued by regulatory authority of Certificate No.6080699 Issued to: M/s Anuh Pharma Ltd, India.
country of origin. Issued by: Food & Drug Administration, Konkan Division, Maharashtra
State.
Validity: Valid Till 21-03-2019.
5. Mechanism for Vendor pre- The firm has submitted SOP for Evaluation of Vendors.
qualification
6. Certificate of analysis of the API, Applicant has submitted following COAs:
reference standards and impurity  Copy of COA of API (batch # APL/191/1-17) from M/s Anuh
standards. Pharma Ltd. India has been submitted.
 Copy of COA of reference standard of Deflazacort (batch #
APL/150/G-17) has been submitted.
7. Documents for the procurement of The firm has submitted photocopy of Commercial
excipients used in product invoices/COAs of all the excipients used in the
development? formulation of applied product.
 Commercial invoice dated 03-11-16 for Magnesium Stearate
8. List of qualified staff involved in The firm has submitted List of qualified staff involved in R&D department.
product development with relevant
experience.
Production Data
9. Authorized Protocols/SOP for the Development The firm has submitted photocopy of ―Protocols/SOP for the
& stability testing of trial batches. Development of Deflazot Tablets 6mg
Mfg. Date
Mar-18
Trial # 01 1500 tablets
Mar-18
Mar-18
Trial Total no. of Used quantities Remaining

no. tablets for quantities
stability
20‘s) 20‘s) 20‘s)
20‘s) 20‘s) 20‘s)
20‘s) 20‘s) 20‘s)

QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger record
and humidity monitoring of stability for chambers used in Real Time & Accelerated stability
chambers (real time and accelerated) studies of applied product from 01-05-2018 to 13-02- 2019.
COA. Raw Material Test/Analysis Procedures & Raw
Material Specifications Of Deflazacort (in house) .
excipients used.
in Pakistan.
Sr.# Deficiencies/Shortcomings Reply by Firm
1. In all 3 batches final mixing of powder In all three batches final mixing of granules was done on 31-
was done on (31-03-2018) and 03-2018, and in process analysis carried out on 03-04-2018,
compression done on 25-04-2018 then trial was compressed into two steps. Initially small amount
.Justify.. of granules were compressed on 21-04-2018. After its analysis
on 23-04-2018 (compressed tablets) the remaining granules
were compressed on 25-04-2018. Granules were stored/kept in
sealed bag and well closed container during the process
Evidence weight variation sheet (attached)
2. In all 3 batches compression was done on As the compression of tablets done in two steps, the analytical
25-04-2018 while some analytical test tests like D.Time, Friability etc., for initially compressed tablet
were performed on 21-04-2018 as per was carried out on 21-04-2018 on the date of initial
submitted batch manufacturing record. compression and remaining granules were compressed on 25-
Justify 04-2018 as evident from weight variation sheet
3. In all 3 batches approval for blistering The Initial compression of the batches was done on 21-04-2018
was 24-04-2018 while compression after which the compressed tablet were analysed on 24-04-2018
done on 25-04-2018. Justify and approval for the blistering for initially compressed tablets
was given. However, the remaining granules were compressed
on 25-04-2018 and the process of blistering was carried out on
30-04-2018. In this way the trial got compressed in two steps.
The whole trial was not initially compressed due to limited
quantity of API and once the initially compressed tablets were
passed the remaining trial got compressed.
816. Name and address of manufacturer / M/s Werrick pharmaceuticals, 216-217, I-10/3, Industrial Area,
Pack size & Demanded Price 10's, 20's, 30's ; As per SRO
Me-too status (with strength and CALCORT TABLETS 6mg of M/s HOECHST KARACHI
dosage form) (Reg No# 025224)
Real Time: 30°C ± 2°C / 65% ± 5%RH
No. of Batches 03
No.
Pharma Ltd. India
country of origin.

Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice No;
EXP/276/2018 dated 20-12-2017 (Deflazacort) attested by
ADC, DRAP, Islamabad dated; 18-01-2018
/ documents.
Yes
Rules, 1978.
the following documents in conjunction with the checklist approved by the Registration Board in its 278 th Meeting
instant dosage form conducted during last two product ―Cell-Tab 400mg (Sofosbuvir) Tablets‖, which was
years. presented Initially in 256th subsequently in 269th&finally in
276th meeting of Registration board.
above stated drug product of M/s. Werrick
approval from DRAP (in case of import). EXP/276/2018 dated 20-12-2017 (Deflazacort) attested by
ADC, DRAP, Islamabad dated; 18-01-2018.
standard and impurity standards. standard :
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate
API manufacturer issued by regulatory declaring following information:
authority of country of origin. Certificate No.6080699 Issued to: M/s Anuh Pharma Ltd,
India.
standards and impurity standards  Copy of COA of API (batch # APL/191/1-17) from
M/s Anuh Pharma Ltd. India has been submitted.
 Copy of COA of reference standard of Deflazacort
(batch # APL/150/G-17) has been submitted.
7. Documents for the procurement of excipients The firm has submitted photocopy of Commercial
used in product development? invoices/COAs of all the excipients used in the
 Commercial invoice dated 03-11-16 for Magnesium
Stearate
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved
development with relevant experience. in R&D department.

Production Data
9. Authorized Protocols/SOP for the Development The firm has submitted photocopy of ―Protocols/SOP
Mfg. Date
Apr-18
Apr-18
Apr-18

stability
20‘s) 20‘s) 20‘s)
20‘s) 20‘s) 20‘s)
20‘s) 20‘s) 20‘s)
QA / QC DATA
and humidity monitoring of stability chambers for chambers used in Real Time & Accelerated stability
(real time and accelerated) studies of applied product from 01-05-2018 to 13-02- 2019.
COA. Raw Material Test/Analysis Procedures & Raw
Material Specifications Of Deflazacort (in house) .
record of testing of stability batches (i.e. FPP Test/Analysis Method & FPP Specifications (In-
chromatograms, lab reports, raw data sheets etc.) house) for Deflazot Tablets 30mg.
manufacturer. and 36 Months Real Time Stability Study Data of 03
Batches of Deflazacort from M/s Anuh Pharma Ltd, India
according to zone IVA conditions.
excipients used.
in Pakistan.

Sr.# Deficiencies/Shortcomings Reply by Firm
1. In all 3 batches final mixing of powder was In all three batches final mixing of granules was done on
done on (12-04-2018) and compression was 12-04-2018, and in process analysis carried out on 25-04-
done on (27-04-2018) .Justify. 2018, then trial was compressed into two steps. Initially
small amount of granules were compressed on 25-04-
2018. After the analysis compressed tablets the remaining
granules were compressed on 27-04-2018. Granules were
stored/kept in sealed bag and well closed container during
the process
2. In all 3 batches approval for blistering was 26- The Initial compression of the batches was done on 25-04-
04-2018 while compession done on 27-04- 2018 after which the compressed tablet were analysed on
2018. Justify 26-04-2018 and approval for the blistering for initially
compressed tablets was given. However, the remaining
granules were compressed on 27-04-2018 and the process
of blistering was carried out on 02-05-2018. In this way
the trial got compressed in two steps. The whole trial was
not initially compressed due to limited quantity of API
and once the initially compressed tablets were passed the
remaining trial got compressed.
3. In all 3 batches compression done on 27-04- As the compression of tablets done in two steps, the
2018 while some analytical test were analytical tests like D.Time, Friability etc., for initially
performed on 25-04-2018 as per submitted compressed tablet was carried out on 25-04-2018 on the
batch manufacturing record. Justify date of initial compression and remaining granules were
compressed on 27-04-2018 as evident from weight
variation sheet.
Pack size & Demanded Price 10's, 20's, 30's ; As per SRO
Me-too status (with strength and Not avaiable
dosage form)

Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 9 Months
No. of Batches 03
No.
Pharma Ltd. India
country of origin.
Yes
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice No.EXP/
276 /2018 dated 20-12-2017 (Deflazacort) attested by ADC,
DRAP, Islamabad dated; 18-01-2018
/ documents.
Yes
Rules, 1978.
following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their product
instant dosage form conducted during last two ―Cell-Tab 400mg (Sofosbuvir) Tablets‖, which was
years. presented Initially in 256th subsequently in 269th &finally in
276th meeting of Registration board.
Registration Board decided to approve registration of above
stated drug product of M/s. Werrick Pharmaceuticals.
approval from DRAP (in case of import). EXP/276/2018 dated 20-12-2017 (Deflazacort) attested by
ADC, DRAP, Islamabad dated; 18-01-2018.
standard and impurity standards. standard:
4. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate declaring
manufacturer issued by regulatory authority of following information:
country of origin. Certificate No.6080699Issued to: M/s Anuh Pharma Ltd,
India.
standards and impurity standards  Copy of COA of API (batch # APL/191/1-17) from
M/s Anuh Pharma Ltd. India has been submitted.
 Copy of COA of reference standard of Deflazacort
(batch # APL/150/G-17) has been submitted.
used in product development? invoices/COAs of all the excipients used in the
 Commercial invoice dated 03-11-16 for Magnesium
Stearate
development with relevant experience. in R&D department.
Production Data
9. Authorized Protocols/SOP for the Development The firm has submitted photocopy of ―Protocols/SOP
10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch
stability batches. Manufacturing Record of the following 03 Batches
Mfg. Date
Apr-18
Apr-18
Apr-18

stability
20‘s) 20‘s) 20‘s)
20‘s) 20‘s) 20‘s)
20‘s) 20‘s) 20‘s)
QA / QC DATA
and humidity monitoring of stability chambers for chambers used in Real Time & Accelerated stability
(real time and accelerated) studies of applied product from 01-05-2018 to 13-02- 2019.
COA. Raw Material Test/Analysis Procedures & Raw Material
Specifications Of Deflazacort (in house) .
excipients used.
in Pakistan.
Sr. No. Deficiencies/Shortcomings Reply by Firm
1. In all 3 batches final mixing of powder was In all three batches final mixing of granules was done on
done on (17-04-2018) and compression 18-04-2018, and in process analysis carried out on 25-
done on (30-04-2018) . Justify 04-2018, then trial was compressed into two steps.
Initially small amount of granules were compressed on
26-04-2018. After its analysis on 27-04-2018
(compressed tablets) the remaining granules were
compressed on 30-04-2018. Granules were stored/kept in
sealed bag and well closed container during the process
2. In batch No. T# 01 & T# 02 approval for The Initial compression of the Trial #01 & 02 was done
blistering was 27-04-2018 while on 26-04-2018 after which the compressed tablet were
compression done on 30-04-2018. Justify. analysed on 27-04-2018 and approval for the blistering
for initially compressed tablets was given. However, the
remaining granules were compressed on 30-04-2018 and
the process of blistering was carried out on 02-05-2018.
In this way the trial got compressed in two steps. The
whole trial was not initially compressed due to limited
quantity of API and once the initially compressed tablets
were passed the remaining trial got compressed.
3. In batch No. T#03 approval for blistering The Initial compression of the Trial #03 was done on 26-
was 28-04-2018 while compassion done 04-2018 after which the compressed tablet were analysed
on 30-04-2018 on 28-04-2018 and approval for the blistering for
initially compressed tablets was given. However, the
remaining granules were compressed on 30-04-2018 and
the process of blistering was carried out on 02-05-2018.
In this way the trial got compressed in two steps. The
whole trial was not initially compressed due to limited
quantity of API and once the initially compressed tablets
were passed the remaining trial got compressed.
4. In all 3 batches compression on 30-04- As the compression of tablets done in two steps, the
2018 while some analytical test were analytical tests like D.Time, Friability etc., for initially
performed on 26-04-2018 as per submitted compressed tablet was carried out on 26-04-2018 on the
batch manufacturing record. Justify date of initial compression and remaining granules were
compressed on 30-04-2018 as evident from weight
variation sheet.
Evaluator PEC-V
a. New Cases
818. Name and address of manufacturer / M/s Mission Pharmaceuticals Pvt Ltd. Plot No. A-94, S.I.T.E.
Applicant Super Highway Karachi, Pakistan
Brand Name +Dosage Form + Strength Mismol 500mg Tablet
Paracetamol…500mg
Diary No. Date of R& I & fee Dy. No. 6826, 22-02-2018, Rs. 20,000/- (22-02-2018)
Pharmacological Group Analgesics
Type of Form Form- 5
Pack size & Demanded Price 200‘s for Rs. 180/-, Jar of 1x1000‘s: Rs, 665/-
Approval status of product in Reference MHRA Approved
Me-too status Feveren Tablet 500mg of M/s Asian Continental Karachi (Reg. #
076689)
Remarks of the Evaluator  General tablet section is available in the firm as
mentioned in the submitted section approval letter.
Decision: Approved.
819. Name and address of manufacturer / M/s Mission Pharmaceuticals Pvt Ltd. Plot No. A-94, S.I.T.E.
Applicant Super Highway Karachi, Pakistan
Brand Name +Dosage Form + Strength Merzole 40mg capsule
Esomeprazole Magnesium (enteric-coated
pellets)……………………………...40mg
Diary No. Date of R & I & fee Dy. No. 6828,22-02-2018, Rs. 20,000/- (22-02-2018)
Pack size & Demanded Price 7‘sx2 &Rs. 323.00/-
Me-too status Esoact 40mg capsule of M/s UmemaPharmaBalochistan (Reg. #
076535)
Remarks of the Evaluator.  General capsule section is available in the firm as
Source of pellets is M/s Vision Pharma.
 CoA of manufacturer, stability data of pellets and GMP
certificate of manufacturer is submitted by the firm
which was valid until 25-01-2019.
Decision: Approved.
820. Name and address of manufacturer / M/s WelbornePharmachem and Biologicals, Plot no. 51/1, 52/2,
Applicant Phase I and II Industrial Estate , Hattar, Pakistan
Brand Name +Dosage Form + Strength Nebron Tablet 2.5mg
Nebivolol as HCl………..2.5mg
Diary No. Date of R& I & fee Diary No:3056, 23/01/2018, Rs: 20,000/- Dated 22/01/2018
Pharmacological Group Beta blocking agents, selective
(C07AB12)
Type of Form Form 5
Finished product Specification Not claimed
Pack size & Demanded Price 2x7‘s , AluAlu Blister, As per SRO
Approval status of product in Reference Bystolic
Regulatory Authorities USFDA Approved
Me-too status 061344; Nebil 2.5mg Tablet
M/s Getz Karachi
thereport concludes good level of GMP compliance.
Remarks of the Evaluator XIII  The applied formulation is available as uncoated in
MHRA and USFDA while the firm has applied as film-
coated tablet.
 No USP or BP monograph is available for the applied
formulation.
Decision: Deferred for revision of formulation to uncoated tablet as per reference product along with
submission of fee for revision of formulation.
Brand Name +Dosage Form + Strength Nebron Tablet 5mg
Nebivolol as HCl………….5mg
(C07AB12)
Type of Form Form 5
Me-too status 061345
Nebil 5mg Tablet
M/s Getz Karachi
Remarks of the Evaluator XIII
 The applied formulation is available as uncoated in
coated tablet.
formulation.

Brand Name +Dosage Form + Strength Nebron Tablet 10mg
Nebivolol as HCl………..10mg
(C07AB12)
Type of Form Form 5
Me-too status 061345
Nebil 5mg Tablet
M/s Getz Karachi
 The applied formulation is available as uncoated in
coated tablet.
formulation.
B. DEFERRED CASES
823. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd, 539-A Sundar Industrial
Applicant Estate, Raiwind Road ,Lahore
Brand Name +Dosage Form + Strength Diafax Tablet 550mg
Rifaximin……………….550mg
Diary No. Date of R& I & fee Diary No:3061, 23/01/2018, Rs: 20,000/- 18/01/2018
Pharmacological Group Antibiotics (A07AA11)
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 30‘s & As per SRO.
Approval status of product in Reference XIFAXAN®
Regulatory Authorities. USFDA Approved
Me-too status 081073; Rixago 550mg
M/s OBS Pharma Karachi.
GMP status GMP dated 12-2-2018, the GMP compliance status of firm can‘t
be verified because firm was not operational at the time of
inspection however premises were found well maintained and at
satisfactory level.
Previous remarks of the Evaluator Tablet Section is approved.
Previous decision Deferred in 288th DRB meeting for updated status of GMP of the
firm form QA & LT division as inspection report submitted by
firm does not conclude GMP compliant status.
Evaluation by PEC  Firm has submitted its latest GMP inspection report
dated: 29-03-2019 concluding satisfactory level of GMP
compliance.
 Firm has General Tablet section as mentioned in the
submitted GMP inspection report.

824. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd, 539-A Sundar Industrial
Applicant Estate, Raiwind Road,Lahore
Brand Name +Dosage Form + Strength Diafax Tablet 200mg
Rifaximin……………….200mg
Diary No. Date of R& I & fee Diary No:3060, 23/01/2018, Rs: 20,000/- 18/01/2018
Pharmacological Group Antibiotics (A07AA11)
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 30‘s, As per SRO.
Approval status of product in Reference XIFAXAN®
Me-too status 081073; Rixago 550mg
M/s OBS Pharma Karachi.
Previous decision Deferred in 288th DRB meeting for updated status of GMP of the
firm form QA & LT division as inspection report submitted by
firm does not conclude GMP compliant status.
dated: 29-03-2019 concluding satisfactory level of GMP
compliance.
825. Name and address of manufacturer / M/s Hi-Med Pharmaceuticals, Plot No. 208C, Sundar Industrial
Applicant Estate, Lahore
Brand Name +Dosage Form + Strength Itomed tablet 50mg
Itopride as hydrochloride….50mg
Pharmacological Group Gastroprokinetic / Propulsives
Finished product Specification Innovator specifications
Pack size & Demanded Price 10‘s, 30‘s AluAlu Blister, As per SRO
Approval status of product in Reference Approved In PMDA
Me-too status Ganaton 50mg Tablet by M/s Abbott. (Reg. # 028429)
GMP status Grant of New DML Approved dated 13-06-2018
Previous remarks of the Evaluator The formulation is approved in reference regulatory authority as
Itopride hydrochloride whereas, firm has applied for Itopride (as
hydrochloride).
Firm has revised their formulation.
Previous decision Deferred in 284th DRB meeting for submission of fee for revision
of formulation from ―Itopride as hydrochloride‖ to ―Itopride
hydrochloride‖.--
Evaluation by PEC  Firm has revised its formulation with the label claim:
Each film coated tablet contains:
Itopride Hydrochloride….50mg
 Rs. 5000/- fees is submitted by the firm.
Decision:Approved with innovator‘s specification with revised label claim as follows:
Itopride Hydrochloride….50mg

Case no. 02 Registration Applications of Categories to be Considered on Priority.
b. Local Manufacturing Applications of Priority Categories Defined by

Registration Board in its 257th Meeting
826. Name and address of manufacturer / M/s Biomark Pharmaceuticals Plot 527, Sundar
Applicant Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Folic Tablet 5 mg
Composition Each uncoated tablet contains:
Folic Acid ……..…….…5mg
Diary No. Date of R& I & fee Dy.No;16429 Date:03-05-18 , Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 3x10‘s AluAlu Blister
As per SRO (10% less then Brand Leader)
Approval status of product in Reference MHRA approved
Me-too status Folimic tablets 5mg of M/s Alliance
Pharmaceuticals
GMP status Last inspection conducted on 10-03-2017 for Grant
of DML.Panel recommends grant of DML.
Previous remarks of the Evaluator
Previous decision In 284st DRB meeting, Registration Board referred the case
to QA & LT Division to conduct GMP
inspection of Firm on priority.
Evaluation by PEC  Firm has submitted its GMP certificate based on
evaluation conducted on 16-08-2018.
Decision: Approved.
Evaluator PEC-VI
Case no. 01: Registration Applications for Local Manufacturing of (Human) Drugs.
a. New Cases
827. Name and address of manufacturer / M/s Caliph Pharmaceuticals Plot No. 17 Risalpur, KPK
Applicant
Brand Name +Dosage Form + Strength Listate 120mg Capsule

Orlistat……………....120mg
Diary No. Date of R& I & fee Dy.No. 25; 27-12-2017; Rs.20,000/- (27-12-2017)
(Duplicate)
Pharmacological Group Lipase Inhibitor
Type of Form Form-5
Finished product Specification USP Specification
Pack size & Demanded Price As per SRo, As per SRO
Approval status of product in Reference Xenical, orlistat120mg, capsule;oral, USFDA Approved.

Me-too status Trimzak 120mg Capsule BY SchazooZaka (Pvt) Ltd, Lahore.
(Reg.# 071105)
GMP status Firm was granted certificate of cGMP based on evaluation
conducted on 6-11-2018.
Remarks of Evaluator Fee challan Photocopy attached.
Pellets details are not provided.
Decision:Deferred for source of pellets, along with stability studies data, GMP certificate of

B. DEFERRED CASES
828. Name and address of manufacturer / M/s Medera Pharmaceuticals. Plot No.249/A, Industrial,
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Medarone 200mg tablet
AmiodaroneHCl……200mg
Pharmacological Group Antiarrythmatic
Type of Form Form-5
Pack size & Demanded Price 3 x 10‘s As per SRO
Approval status of product in Reference USFDA Approved as uncoated tablet

Me-too status Amid Tablets 20mg by CCL 045972
GMP status 23-11-2017 firm was considered to be operating at fair
compliancewith GMP guidelines.
Remarks of the Evaluator. Me-too status could not be confirmed in the available
database.
Previous Decision: Decision of 287th
Deferred for revision of formulation as per reference product
formulation.
Evaluation by PEC: Firm has deposited Rs. 5,000/- Deposit Slip No. (1921545)
and requested (on covering letter) to change our product from
film coated tablet to uncoated tablet.
The firm has not submitted revised master formulation.
Decision: Deferred for submission of documents and master formulation for uncoated tablet.
829. Name and address of manufacturer / M/s Genome Pharmaceuticals, Hattar

Applicant
Brand Name +Dosage Form + Strength Everogen 3mg Dispersible tablets
Composition Each dispersible tablet contains:
Everolimus……3mg
Pharmacological Group Anti-neoplastic agent
Type of Form Form-5
Finished product Specification Manufacturer‗s Specification
Approval status of product in Reference AFINITOR DISPERZ TABLET FOR ORAL SUSPENSION.
GMP status Panel Inspection on 14-01-2017, No observations as
informed by QA.
Previous Decision: Decision of 281st meeting:
Decision of 288th meeting:
approved by DRAP (generic / me-too status) along with
registration number, brand name and name of firm, or else
application on form-5D alongwith stability data and
differential fee.
Evaluation by PEC: The firm has stated the Afinitor 3mg Dispersible tablet
(Everolimus…….3mg) has been approved in M.263 having
.(Reg. No. 088396)
me-too status) along with registration number, brand name and name of firm, or else application
on form-5D alongwith differential fee.
830. Name and address of manufacturer / M/s Genome Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Everogen 2mg Dispersible tablets
Composition Each dispersible tablet contains:
Everolimus……2mg
Pharmacological Group Anti-neoplastic agent
Type of Form Form-5
Finished product Specification Manufacturer‗s Specification
Approval status of product in Reference AFINITOR DISPERZ TABLET FOR ORAL SUSPENSION.
GMP status Panel Inspection on 14-01-2017, No observations as
informed by QA.
registration number, brand name and name of firm, or else
application on form-5D alongwith stability data and
differential fee.
Evaluation by PEC: The firm has stated the Afinitor 2mg Dispersible tablet
(Everolimus…….3mg) has been approved in M.262.(Reg.
NO. 088397)
me-too status) along with registration number, brand name and name of firm, or else application
on form-5D alongwith differential fee.
831. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd, 30-km, Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Exestane 25mg Tablets
Composition Each film-coated tablet contains:
Exemestane…25mg
Diary No. Date of R& I & fee Diary No:10938, 26/03/2018, Rs. 20,000/-
Pharmacological Group Aromatase inhibitors (Steroidal)
Type of Form Form-5
Pack size & Demanded Price 3x5‘s/ As per SRO
Approval status of product in Reference Aromasin 25 mg coated tablets by M/s Pfizer Limited
Me-too status Ph&TExemestane 25mg Coated Tablets by M/s Mehran
International (Reg#078122)
GMP status 07-11-2017. Panel recommends grant of Additional sections
The Board deferred product and advised the firm to get
approval from Licensing Division particularly for either
Tablet (Steroidal Hormone) or Tablet (Non-steroidal
Hormone) for further processing by Registration Board. .
Deferred for clarification whether the applied product is
hormone or otherwise.
Evaluation by PEC: The firm has stated that this product is Steroidal aromatase
Inhibitor and will be manufactured in Steroidal hormone
Section.
Decision: Deferred for clarification regarding manufacturing facility whether steroidal or non-
steroidal hormone section.
(Veterinary)
a. Deferred Cases
832. Name and address of manufacturer / M/s IntervacPvt Ltd, 18-km, Lahore Sheikhupura Road,
Applicant Sheikhupura
Brand Name +Dosage Form + Strength PBS-250 Injection
Procaine Penicillin…….15 ,00,000IU
Benzyl Penicillin……..5,00,000IU
Streptomycin Sulphate…..2.5gm
Diary No. Date of R& I & fee Dy. No 560.; 22-12-2015; Rs.20,000/- (22-12-2015)
Type of Form Form-5
Finished product Specification Manufacturer‘s
Pack size & Demanded Price 2.5gm sterile powder vial, Decontrolled
Me-too status Penivet 2.5 Injection of Star Laboratories
GMP status CLB in its 264th meeting held on 9th July 2018 approved
2additional sections of the firm.
A) Liquid Injectable (Pencillin Veterinary Section)
B) Dry Powder Injection (Penicillin Veterinary Section)
Remarks of the Evaluator. Me-too status could not be confirmed in the available
database.
approved by DRAP (generic/ me-too status) alongwith
Evaluation by PEC: Firm has provided me-too as: Penivet 2.5gm Injection Reg
No. 008031. It has been confirmed.
833. Name and address of manufacturer / M/s IntervacPvt Ltd, 18-km, Lahore Sheikhupura road,
Brand Name +Dosage Form + Strength Penfas-S Injection
Procaine Penicillin…….15,00,000IU
Benzyl Penicillin……..5,00,000IU
Streptomycin Sulphate…….5gm
Diary No. Date of R& I & fee Dy. No 568.; 22-12-2015; Rs.20,000/- (22-12-2015)
(Duplicate)
Type of Form Form-5
Pack size & Demanded Price 5gm sterile powder vial, Decontrolled

Me-too status Penivet 5 Injetion
Remarks of the Evaluator. Fee challan photocopy attached.
Me-too status could not be confirmed in the available
database.
approved by DRAP (generic/ me-too status) along with
Evaluation by PEC: Firm has provided me-too as: Penivet 5gm Injection Reg
No. 008032. It has been confirmed.
834. Name and address of manufacturer / M/s IntervacPvt Ltd, 18-km, Lahore Sheikhupura road,
Brand Name +Dosage Form + Strength PPS-360 Injectable Suspension
Procaine Penicillin……200mg
Streptomycin Sulphate….160mg
Type of Form Form-5
Pack size & Demanded Price 50ml, Decontrolled

Me-too status Neo-Strepen of NawanReg # 053997
Evaluation by PEC: Firm has provided me-too as: Neo Strepen of Nawan
laboratories Reg No. 053997

Case No. 03: Registration Applications of Import Cases:
A. DEFERRED CASES
I. HUMAN
835. Name and address of Applicant M/s Aster Life Sciences, 32-Babar Block, New Garden Town,
Lahore.
Detail of Drug Sale License Adress: M/s Aster Life Sciences, 32-Babar Block, New Garden
Town, Lahore.
Status: License to sell drugs as a Distributor.
Name and address of manufacturer M/s Panacea Biotec ltd, Village Malpur, Baddi, District Solan-
173205, Himachal Pradesh, India.
Name and address of marketing M/s Panacea Biotec ltd, Village Malpur, Baddi, District Solan-
authorization holder 173205, Himachal Pradesh, India.
Name of exporting country India
Brand Name +Dosage Form + Strength PanimunBioral 25mg capsule(Soft gelatin)
Cyclosporin…..25mg
Pharmacological Group Calcineurin Inhibitors, ATC Code: L04AD01
Shelf life 2Years
Demanded Price Rs. 1500/ 30 Capsules
Rs. 2500/ 50 Capsules
Pack size 6x5‘s blister strips
Me-too status Gengraf Capsules by Abbott
Detail of certificates attached ● Original Legalized COPP (No. of certificate
MB/05/203/WHO/GMP/18-198) issued from Licensing
Authority cum Controlling Authority Baddi-173205,
Dis.Solan, Himachal Pradesh. And is valid upto 11-02-
2020. The product is actually available on the market for
use in the exporting country.
● Photocopy of legalized Certificate of GMP issued from
Health and Family Welfare Department, Himachal Pradesh,
Solan (State Drugs Controller). It is valid upto 25-11-2017.
Certificate No. HFW-II|Drugs|302/05 (Vol-II)
● Letter of authorization issued on 26-09-2017 and is valid
upto 30-April 2020, from M/s Panacea Biotec, India have
submitted
 Firm has submitted 6 months accelerated stability study(40+-2 ‗C, 75RH+-5%) data and 12 months
real-time (30+-2 ‗C, 70RH+-5%) stability study data , 24 months stability data at (25‘C+-2‘C,
60RH+-5%RH) of 5 batches.
Initiation dates:
Batch #108/094A (8-10-2005)
Batch #0243/010 (8-10-2005)
Batch #108/094B (8-10-2005)
Batch #0243/018 (8-10-2005)
Batch #0243/014 (8-10-2005)
Decision of 287th: Deferred for justification of claimed shelf life of 2 years, since firm has submitted long
term stability (30+-2 oC, 70RH+5%) data of 12 months only.
Confirmation from Import Policy order regarding import of applied formulationfrom India.
Evaluation of PEC: The firm has submitted long term stability data of 36 months of 3 batches and

requested to consider our shelf-life as 36 months.
Regarding confirmation of Import policy the firm submitted that formulation is not included in the list of
restricted items.
Lahore.
Town, Lahore.
Shelf life 2Years
Demanded Price Rs. 3000/ 30 Capsules Rs. 5000/ 50 Capsules
Dis.Solan, Himachal Pradesh. And is valid upto 11-02-2020.
The product is actually available on the market for use in the
exporting country.
● Letter of authorization issued on 26-09-2017 and is valid upto
30-April 2020, from M/s Panacea Biotec, India have
submitted
Firm has submitted 6 months accelerated stability study(40+-2 ‗C, 75RH+-5%) data and 12 months real-
time (30+-2 ‗C, 70RH+-5%) stability study data , 24 months stability data at (25‘C+-2‘C, 60RH+-5%RH)
of 5 batches.
Initiation dates:
Batch #108/094A (8-10-2005)
Batch #0243/010 (8-10-2005)
Batch #108/094B (8-10-2005)
Batch #0243/018 (8-10-2005)
Batch #0243/014 (8-10-2005)
Decision of 287th: Deferred for justification of claimed shelf life of 2 years, since firm has submitted long
term stability (30+-2 oC, 70RH+5%) data of 12 months only.
Lahore.
Town, Lahore.
Shelf life 2Years
Demanded Price Rs. 4800/ 30 Capsules
Rs. 8000/ 50 Capsules
Dis.Solan, Himachal Pradesh. And is valid upto 11-02-
2020. The product is actually available on the market for
use in the exporting country.
● Letter of authorization issued on 26-09-2017 and is valid
upto 30-April 2020, from M/s Panacea Biotec, India have
submitted
 Firm has submitted 6 months accelerated stability study(40+-2 ‗C, 75RH+-5%) data and 12 months
real-time (30+-2 ‗C, 70RH+-5%) stability study data , 24 months stability data at (25‘C+-2‘C,
60RH+-5%RH) of 5 batches.
Initiation dates:
Batch #108/094A (8-10-2005)
Batch #0243/010 (8-10-2005)
Batch #108/094B (8-10-2005)
Batch #0243/018 (8-10-2005)
Batch #0243/014 (8-10-2005)
Decision: Deferred for justification of claimed shelf life of 2 years, since firm has submitted long term
stability (30+-2 oC, 70RH+5%) data of 12 months only.

Case No.04: Registration Applications of Drugs for which Stability Study Data is
Submitted.
a. Exemption from Onsite Verification of Stability Data.
Exemption case
Sr. Name & Address of Brand Name Type of Form, International REMARKS
No. Manufacturer / (Proprietary Name + Initial Diary & Availability / (IF ANY)
Applicant Dosage Form + Strength), Date, Fee Local Availability
Composition, (including
Pharmacological Group, differential GMP Inspection
Finished Product fee), Report Date &
Specification Demanded Remarks
Price / Pack
size
838. M/s Ferozsons Artril tablets 49mg/51mg Form 5-D USFDA The firm has
Laboratories Limited, Diary No. Approved claimed
Nowshera, KPK Each film coated tablet 1838 dated Manufacturer‘s
contains: 24-8-2018 Specifications.
Sacubitril……...49mg Rs. 50,000/- Last inspection
Valsartan as (Valsartan 20-08-2018, report 10-1-2018,
trisodiumhemipentahydrat 1x14‘s, As per Panel
e)……………….51mg SRO recommended for
the issuance og
Angiotensin II receptor GMP Certificate.
Inhibitor and Neprilyn
Drug Artril tablets 49mg/51mg
Name of Manufacturer M/s Ferozsons Laboratories Limited, Nowshera, KPK
Manufacturer of API M/s Nantong ChanyooPharmatech Co. Ltd. China.
API Lot No. 201706001
Description of Pack Alu/Alu film blister pack
Real Time: 30°C ± 2°C & 75±5%RH
Time Period Accelerated: (6-months) Real Time: (6-months)
Frequency Accelerated: 0,1,2,3,4,6 months
Batch No. SV tab-001 SV tab-002 SV tab-003
Manufacturing Date December-2017 December-2017 December-2017
Date of Initiation December-2017 December-2017 December-2017
No. of Batches 3
Date of Submission 20-08-2018
No.
1. COA of API Copy of COA from Nantong ChanyooPharmatech
Co. Ltd. China. is submitted.

2. Approval of API by regulatory authority of country of GMP certificate issued from Nantong Chemical and
origin or GMP certificate of API manufacturer issued Medical Industry is valid until 5-12-2019.
by regulatory authority of country of origin.
respective documents like chromatograms, laboratory
documents.
1978.
PREVIOUS REMARKS OF EVALUATOR1

DECISION 275TH RB MEETING
Registration Board deliberated that it has been decided that onsite inspection for verification of data will be
exempted as decided in instant meeting.
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide
Letter dated 19-10-2018 and provided the following documents in conjunction with the checklist approved by the
Registration Board in its 276th Meeting:
1. Reference of last onsite panel inspection for  Registration Board approved ―Invicta (Sofosbuvir 400mg
instant dosage form conducted during last two + Velpatasvir 100mg)‖ Tablets in its 281st Meeting.
years.  Dates of Inspection:
o 16th March 2018.
2. Documents for the procurement of API with Firm has attested form-6 that permits the import of 2kg of
approval from DRAP (in case of import). Sacubitril + Valsartan from M/s Nantong
ChanyooPharmatech Co. China.
3. Documents for the procurement of reference  The firm has provided Invoice No. CY117235 Dated 26
standard and impurity standards. Jun 2017 of importing Working standard and Impurity
standard.
4. Approval of API/ DML/GMP certificate of GMP certificate issued from Nantong chemical and Medical
API manufacturer issued by regulatory Industry association and is valid until 5-12-2019.
authority of country of origin.
5. Mechanism for Vendor pre-qualification Firm has given procedure for Induction of New Vendor for
evaluation of vendors.
6. Certificate of analysis of the API, reference Photocopy of COA of Batch No. 201706001 by Nantong
standards and impurity standards ChanyooPharmatechCo.Ltd is submitted.
Working standards: Photocopy of COA of Batch No.
WS201610001 is submitted.
Impurity Standard: Photocopy of COA of impurity
standards are submitted.
7. Documents for the procurement of excipients The firm has submitted photocopy of Commercial Invoice
used in product development? from M/s JRS Pharma, Germany dated 3-07-2017 for
purchase Alufoil-bag.
The firm has submitted photocopy of Commercial Invoice

from M/s Z.Son Enterprises, Peshawar dated 24-10-2017
for the purchase of 1kg LHPC.
from M/s B.B Mineral dated 26-08-2017 for purchase of
Talcum powder.
from M/s Axis Chemicals, Karachi dated 2-10-2017 for
purchase of Magnesium sterate,.
from M/s Colorcon, England dated 3-4-2017 for purchase of
Opadry 200 yellow.
development with relevant experience. involved in product development with relevant experience.
Production Data
9. Authorized Protocols/SOP for the The firm has written and authorized protocol for the
development & stability testing of trial development of product.
batches.
stability batches. Record and Batch Packaging Record of the following 03
Batches:
SV Tab-001 2500 Tablets December-2017
11. Record of remaining quantities of stability Batch Testing No. of Total Remaining
batches. No. Frequency tablets number of Quantity
consumed tablets (Approx)
per test consumed
Trial # For 882 280
01 Accelerated
For Real Time
Trial # For 798 280
02 Accelerated
For Real Time
Trial # For 798 280
03 Accelerated
For Real Time
QA / QC DATA
12. Record of Digital data logger for temperature Now the firm has submitted photocopies of Log-it Chart
and humidity monitoring of stability chambers (Humidity and temperature) starting from 31-Dec-2017 to30-
(real time and accelerated) Aug-2018.
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material
COA. Specifications, Raw Material Testing Procedures along with
COA.
record of testing of stability batches (i.e. Testing Procedure along with Stability Study Report &
chromatograms, lab reports, raw data sheets Supporting data for testing of stability batches.
etc.)
15. Reports of stability studies of API from The firm has submitted photocopy of 12 Months stability real
manufacturer. time report of API at 25‘C+-2‘C/ 60%+-5% and 6 Months
accelerated Stability report at (40‘C+_2‘C/75%+-5%RH)
Study Data of 03 Batches.
16. Analysis reports for excipients used. The firm has submitted photocopy of Certificates of Analysis
for excipients used.
17. Drug-excipients compatibility studies.  The firm has submitted that we have used same excipients

as that of Innovator‘s product i.e. Entresto 49mg/51mg of
Novartis.
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study of their
product with Entresto tablet of M/s Novartis
Pharmaceuticals. The details are as follows:
Feature Reference Product of
Product Scotmann
 Brand name  Entresto  Artril tablet

tablet
 Batch No.  FX000010  SVtab-001
 Mfg. date   December-

2017
 Comparative dissolution study was performed in

following media(volume: 900ml, RPM= 50, Apparatus=
Paddle ):
 0.1N HCl
 Acetate Buffer pH 4.5
 Phosphate buffer pH 6.8
19. Compliance Record of HPLC software 21CFR The firm has submitted as follows:
& audit trail reports on product testing.  Certificate of Compliance developed by Shimadzu
Corporation, Analytical & Measurement Instruments
Division 1 Nishinokyo-Kuwabaracho, Nakagyo-Ku,
Kyoto, Japan
 The firm has submitted photocopy of Audit Trails.
Remarks: The firm has submitted photocopy of 12 Months stability real time report of API at 25‘C+-2‘C/ 60%+-
5% and 6 Months accelerated Stability report at (40‘C+_2‘C/75%+-5%RH) Study Data of 03 Batches.
Decision 287th meeting: Registration Board deferred for submission of stability data of API from manufacturer as
per Zone-IVA conditions.
Evaluation by PEC: The firm has now submitted long term stability data of API (30 oC±2oC/65%RH±5%RH) for
18months of 3 batches.
Decision: Registration Board decided to approve registration of Artril tablets 49mg/51mg by M/s Ferozsons
Laboratories Limited, Nowshera, KPK. Manufacturer will place first three production batches of both
products on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.
Evaluator PEC-VIII
Case No. 01 Registration Applications for Local Manufacturing of (Human) Drugs.
a. New cases
839. Name and address of Manufacturer / M/s Winthrox Laboratories (Pvt.) Ltd, K-219-A, SITE, Super
Applicant Highway, Phase-II Karachi, Pakistan.
Brand Name + Dosage Form + Strength Pozwin tablet 15/2mg
Pioglitazone ( as hydrochloride)…15mg
Glimepiride….2mg
Diary No. Date of R&I & fee DyNo.3788; 30-01-2018; Rs. 20,000/-
Pharmacological Group Anti-Diabetic
Type of Form Form-5
Finished Product Specification Manufacturers Specifications

Me-too status Glio-P Tablet of Macter International (Pvt) Ltd, Karachi
GMP status Certificate of cGMP is issued to the firm based on inspection
conducted on 16-08-2018 & is valid for a period of one year.
Remarks of Evaluator Applied formulation is film coated tablet which is different from
Reference product i.e. uncoated tablet. Submit Form 5, Master
formulation & manufacturing method either in line with
reference product along with required fee or evidence of
reference product as film coated tablet.
 In response to above query firm has submitted revised
Form 5 with change in composition & fee challan of Rs.
5000/- dated 12-03-2019for change in formulation.
840. Name and address of Manufacturer / M/s Winthrox Laboratories (Pvt.) Ltd, K-219-A, SITE, Super
Applicant Highway, Phase-II Karachi, Pakistan.
Brand Name + Dosage Form + Strength Winralex Oral Drops10mg/ml
Escitalopram (as oxalate)…10mg
Pharmacological Group Anti-Depressant
Type of Form Form-5
Approval status of product in Reference Approved in MHRA(not verifiable)
Me-too status Depsit 10mg/ml Oral Drops of Genix Pharma Karachi
Remarks of Evaluator Reference product is approved as Escitalopram (as oxalate) 1
mg/ml drops, which is different form applied formulation i.e.
Escitalopram (as oxalate) 10mg/ml. Submit form 5, master
formulation, manufacturing method either in-line with reference
product or evidence of approval of applied formulation.
authorities/agencies which were adopted by Registration Board in its 275th meeting.
841. Name and address of manufacturer / WINTHROX LABORATORIES (PVT.) LTD.
Applicant K-219-A, SITE, Superhighway, Phase-II Karachi, Pakistan.
Brand Name +Dosage Form + Strength Erinoc Tablets 50mg
Each sugar Coated Tablets contains:
Composition:
Eperisone hydrochloride……………. 50mg
Diary No. Date of R& I & fee: Dy No. 3780; 30-01-18: Rs. 20,000
Pharmacological Group Muscle Relaxant
Type of Form Form-5
Approval status of product in Approved in AIFA(Italy)
Reference Regulatory Authorities. Expose 50mg film coated tablets by ALFASIGMA S.P.A.
Me-too status Eperinal Tablets 50mg of Global Pharmaceuticals
Reference product is Eperisone hydrochloride 50mg film coated
tablet but you have applied with sugar coating, Submit form,
master formulation, manufacturing method either in-line with
reference product along with requisite fee or evidence of approval
of applied formulation with sugar coating.
 In response to above query Firm has submitted evidence
of applied drug product in AIFA which is also of Film
coated tablet.

Brand Name +Dosage Form + Strength COXWIN 60mg Tablets
Each Film Coated Tablets contains:
Composition:
Etoricoxib ……………….. 60mg
Diary No. Date of R& I & fee Diary
Dy No. 3781; 30-01-18: Rs. 20,000
No:
Pharmacological Group Anti-inflammatory And Anti-rheumatic Products, Non-Steroids
Type of Form Form-5
Approval status of product in Approved in MHRA
Me-too status Starcox 60 mg tab by Getz Pharma
Monograph for test/analysis of applied formulation is not present
in available USP & B.P.
Brand Name +Dosage Form + Strength POZWIN TABLETS
Composition: Glimepiride…………. 2mg
Pioglitazone as hydrochloride….. 30mg
Dy. No. 3789; 30-01-18: Rs. 20,000
No:
Pharmacological Group Combination of blood glucose lowering drugs
Type of Form Form-5
Approval status of product in Duetact tablet by Takeda
Me-too status Piozer G by Hilton
Applied formulation is film coated tablet which is different from
formulation & manufacturing method either in line with reference
product along with required fee or evidence of reference product
as film coated tablet.
 In response to above query firm has submitted revised
Form 5 with change in composition & fee challan of Rs.
5000/- dated 12-03-2019for change in formulation.
Brand Name +Dosage Form + Strength Tifany Syrup 1mg/5ml
Each 5ml contains:
Composition:
Ketotifen (as hydrogen fumarate) …1mg
Dy No. 3779; 30-01-18: Rs. 20,000
No:
Type of Form Form-5
Approval status of product in Zaditen 1 mg / 5 ml oral solution by M/s SIGMA
Reference Regulatory Authorities. TAU, ANSM approved (as provided by the firm)

Me-too status Zatofen 1mg/5ml Syrup by M/s Novartis
Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by
Remarks of the Evaluator. the Registration Board in its 275th meeting as provided evidence is
different from the applied formulation, in the sense that it
Ketotifen (as fumarate) not as Ketotifen (as hydrogen fumarate).
authorities/agencies which were adopted by Registration Board in its 275th meeting
Brand Name +Dosage Form + Strength FLEXABENZ-XR Capsule 30mg
Cyclobenzaprine hydrochloride …30mg
Composition:
(Extended release pellets)
Source: Vision Pharmaceuticals
Type of Form Form-5
Finished Product Specification USP specifications
Approval status of product in Amrix extended release capsule of Teva Pharms intl,
Me-too status Emrix-SR of Getz Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength FLEXABENZ-XR Capsule 15mg
Cyclobenzaprine hydrochloride …15mg
Composition:
(Extended release pellets)
Source: Vision Pharmaceuticals
Type of Form Form-5
Approval status of product in Amrix extended release capsule of Teva Pharms intl,
Me-too status Emrix-SR of Getz Pharma
Decision: Approved.
847. Name and address of manufacturer M/s Seatal (Private) Limited, 45-km Multan Road Lahore.
/ Applicant
Brand Name +Dosage Form + Avulus tablet 5mg
Strength
Composition Each film coated contains:
Escitalopram(as oxalate)….5mg
Diary No. Date of R& I & fee Dy No.598; 30-12-2015; Rs.20,000/-
Pharmacological Group Selective Serotonin Reuptake Inhibitors
Type of Form Form-5

Pack size & Demanded Price 10‘s, 20‘s, 30‘s; As per PRC
Me-too status Safepram tablet 5mg of Martin Dow
GMP status GMP inspection conducted on 25-10-2018concluded that firm is
operating at good level of cGMP compliance.

Decision: Approved.
848. Name and address of manufacturer / M/s Seatal (Private) Limited, 45-km Multan Road Lahore.
Applicant
Strength

Type of Form Form-5
Decision: Approved.
849. Name and address of manufacturer / M/s Seatal (Private) Limited, 45-km Multan Road Lahore.
Applicant
Strength

Type of Form Form-5
Decision: Approved.
850. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot #122 Phase 5, Block B,
Applicant Industrial Hattar
Brand Name+Dosage Form + Strength Welnaz 200mg tablet
Each Film Coated Tablet Contains:
Composition
Voriconazole…200mg"
Diary No. Date of R& I & fee Dy. No. 3980; 31-01-18: Rs. 20,000

Type of Form Form-5
Finished Product Specification Manufacturer‘s Specifications
Approved in US-FDA
Me-too status Vorinaz 200mg Tablet of Atco Lab. Karachi
GMP inspection conducted on 16-09-2017 shows that firm is GMP
GMP status
compliant.
Decision: Approved with Japanese Pharmacopoeia Specifications.
851. Name and address of manufacturer / M/s Welmark Pharmaceuticals.
Applicant Plot #122 Phase 5, Block B, Industrial Hattar
Brand Name+Dosage Form + Strength Markfene 50mg Tablet
Each Tablet Contains:
Composition
Clomiphene Citrate…50mg
Diary No. Date of R& I & fee Dy. No. 3978; 31-01-18: Rs. 20,000
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form-5
Approved in US-FDA
Me-too status Clomidex Tablets 50 mg of CSH, Pharmaceuticals-North (Pvt.) Ltd.
GMP inspection conducted on 16-09-2017 shows that firm is GMP
GMP status
compliant.
Firm has submitted ―Tablet Hormone Section‖ approval letter. Is it a
Remarks of the Evaluator required manufacturing facility or it has to be manufactured in
general section?
Decision: Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and personnel
which remain in direct contact or are involved in close handling of these drugs.
852. Name and address of manufacturer / Hicon Pharmaceuticals, 131, Industrial Estate, Hayatabad,
Applicant Peshawar.
Brand Name +Dosage Form + Strength Trevomol Tablets 325mg/37.5mg
Composition Paracetamol….. 325mg
Tramadol hydrochloride …37.5mg
Diary No. Date of R& I & fee Diary No Dy No. 24469; 30-01-18: Rs. 20,000
Pharmacological Group Analgesic/ Opioid Analgesics
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s: As per SRO
Approved in US-FDA
Me-too status Misadol Plus Tablet of Mission Pharma. Karachi
GMP inspection conducted on 26-07-2017shows that firm is
GMP status
operating at satisfactory level of cGMP.
Decision: Approved.
853. Name and address of manufacturer / Hicon Pharmaceuticals, 131, Industrial Estate, Hayatabad.
Applicant Peshawar.
Brand Name +Dosage Form + Strength GLIMM-P Tablets 4mg/30mg

Glimepiride….4mg
Pioglitazone (as hydrochloride) …30mg
Diary No. Date of R& I & fee Diary No Dy. No. 24472; 14-12-18: Rs. 20,000
Pharmacological Group Anti-diabetic
Type of Form Form-5
Approved in US-FDA
Dazemep plus Tablet 4/30 of Lowitt Pharmaceutical (Pvt) Ltd,
Me-too status
GMP inspection conducted on 26-07-2017shows that firm is
GMP status
operating at satisfactory level of cGMP.
Remarks of the Evaluator product along with required fee or evidence of reference product as
film coated tablet.
 Firm has submitted revised form 5 & Fee challan of Rupee
5000/- Dated 01-03-2019 for revision of formulation.
Decision: Approved.
854. Name and address of manufacturer / Hicon Pharmaceuticals, 131, Industrial Estate, Hayatabad,
Applicant Peshawar.
Brand Name +Dosage Form + Strength Cardopin Plus Tablets 10mg/160mg/12.5mg
Each Film Coated Tablet Contains:
Amlodipine (as besylate)…10mg
Composition
Valsartan.......................…160mg
Hydrochlorothiazide….......12.5mg
Type of Form Form-5
Approved in US-FDA
Me-too status Valtec AMH 10/160/12.5 Tablet of Tabros Pharma Karachi
Decision: Approved.
855. Name and address of manufacturer / Hicon Pharmaceuticals, 131, Industrial Estate, Hayatabad.
Applicant Peshawar.
Brand Name +Dosage Form + Strength GLIMM-P Tablets 2mg/30mg
Composition Glimepiride….2mg
Pioglitazone (as hydrochloride) …30mg
Type of Form Form-5
Approved in US-FDA
Me-too status Pio-Glee Tablet of M/s Rasco Pharma
product along with required fee or evidence of reference product as
film coated tablet.
 Firm has submitted revised form 5 & Fee challan of Rupee
5000/- Dated 01-03-2019 for revision of formulation.
Decision: Approved.
856. Name and address of manufacturer / M/s Nabiqasim Industries Pvt Ltd.
Applicant 17/24, Korangi Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Carelox 100mg Tablet
Cefpodoxime ( as proxetil) …100mg
Diary No. Date of R& I & fee Dy No. 6113: 19-02-18 ; Rs. 20,000
Type of Form Form-5
Finished product Specification USP Specifications
Me-too status Sefpotil 100mg Tablet of Lisko
GMP status Based on the area inspected, people met, and documents reviewed
and considering the finding of the inspection, M/s Nabi Qasim
Karachi is considered to be operating at an acceptable level of
Decision: Approved.
857. Name and address of manufacturer / M/s Nabiqasim Industries Pvt Ltd.
Applicant 17/24, Korangi Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Scabex 5% Lotion
Permethrin…50mg"
Pharmacological Group Pyrethrines, incl. synthetic compounds
Type of Form Form-5
Finished product Specification Innovator s Specifications
Me-too status Plaveo Lotion 50mg/ml of Hiranis Karachi
Decision: Approved.
858. Name and address of manufacturer / "M/s Wilson's Pharmaceuticals, 387-388, I-9, Industrial Area,
Brand Name +Dosage Form + Strength Talergin-EB 20mg Tablets
Ebastine…20mg
Type of Form Form-5
Finished product Specification Manufacturers Specifications
Pack size & Demanded Price 10‘s, 20‘s, 30‘s: As per SRO
Approval status of product in Reference Could not beconfirmed
Me-too status Lobastin Tablet 20mg of Lowitt Pharmaceutical (Pvt) Ltd,
GMP status Overall the firm was found to be operating at a very good level of
CGMP Compliance at the time of inspection.

Remarks of the Evaluator Evidence of approval of applied formulation in reference regulatory
Registration Board in its 275th meeting, as the provided evidence is
not verifiable.
authorities/agencies which were adopted by Registration Board in its 275thmeeting.
859. Name and address of manufacturer / "M/s Welmed Pharmaceuticals Industries (Pvt) Ltd.
Applicant Plot # 108, R:2, Industrial Estate Gadoon, Swabi"
Brand Name +Dosage Form + Strength Clarimed 500mg Tablet
Clarithromycin…500mg"
Type of Form Form-5
Approval status of product in Reference Approved in MHRA
Me-too status Claramet -500 Tablets of M/s Metro Pharmaceuticals.
GMP status GMP Inspection conducted on 12-12-2018 concluded that the firm
has rectified majority of Observations noted in the previous
inspection and the management is committed to further improve
their CGMP compliance. The firm may be considered to be
operating in satisfactory level of CGMP compliance.
Decision: Approved with USP Specifications.
860. Name and address of manufacturer / "M/s CKD Pharmaceuticals Pakistan Private Limited.
Applicant Plot No. 50/28, Korangi Industrial Area, Karachi"
Brand Name +Dosage Form + Strength Furaz Tablet 100mg
Furazolidone…100mg"
Pharmacological Group Antidiarrheal
Type of Form Form-5
Approval status of product in Reference Approved in US-FDA(but discountinued)
Me-too status Fydin Tablets of Healers Pharmaceuticals, Peshawar.
GMP status Firm is rated as GMP Compliant based on inspection conducted on
04/09/2018.
861. Name and address of manufacturer / "M/s Welmed Pharmaceuticals Industries (Pvt) Ltd.
Applicant Plot # 108, R:2, Industrial Estate Gadoon, Swabi"
Brand Name +Dosage Form + Strength Clarimed 250mg Tablet
Clarithromycin…250mg"
Type of Form Form-5
Me-too status Claramet -250 Tablets of M/s Metro Pharmaceuticals.
GMP status GMP Inspection conducted on 12-12-2018 concluded that the firm
has rectified majority of Observations noted in the previous
inspection and the management is committed to further improve
their CGMP compliance. The firm may be considered to be
operating in satisfactory level of CGMP compliance.
Applicant Block-22, Federal B industrial Area, Karachi"
Brand Name +Dosage Form + Strength Zodip-V Tablet 10/160mg
Amlodipine(as besylate)…10mg
Valsartan…160mg"
Type of Form Form-5
Me-too status Co-Valzaar 10mg/160mg Tablet of Vision Pharmaceuticals.
GMP status GMP Inspection conducted on 03-01-2018 concluded that firm is
operating at good level of GMP compliance.
Decision: Deferred for correct pharmacological group.
Brand Name +Dosage Form + Strength Zodip-V Tablet 5/160mg
Amlodipine(as besylate)…5mg
Valsartan…160mg"
Type of Form Form-5
Me-too status Co-Valzaar 5mg/160mg Tablet of Vision Pharmaceuticals.
Remarks of the Evaluator 
Approval of section/manufacturing facility by the Central
Licensing Board. However, you may submit panel inspection
report for renewal of DML verifying the section/ manufacturing
facility.
Decision: Deferred for correct pharmacological group.
Brand Name +Dosage Form + Strength Toplan Injection 200mg
Teicoplanin…200mg"
Type of Form Form-5

Me-too status Planin 200mg Injection of S.J &G. Fazul Ellahie, Karachi .
Remarks of the Evaluator  Approval of section/manufacturing facility by the Central
facility.
 Type of primary packaging material
Decision: Deferred for the following:
 Approval of section/manufacturing facility by the Central Licensing Board. However, you may
submit panel inspection report for renewal of DML verifying the section/manufacturing facility.
 Mention type of primary packaging material for applied formulation.
Brand Name +Dosage Form + Strength Toplan Injection 400mg
Teicoplanin…400mg"
Type of Form Form-5
Me-too status Teicon Injection 400mg Of Al Habib Pharmacueticals Karachi
Remarks of the Evaluator  Approval of section/manufacturing facility by the Central
facility.
 Type of primary packaging material
 Approval of section/manufacturing facility by the Central Licensing Board. However, you may
submit panel inspection report for renewal of DML verifying the section/manufacturing facility.
 Mention type of primary packaging material for applied formulation.
866. Name and address of manufacturer / "M/s Hiranis Pharmaceuticals (Pvt.) Ltd, Plot No. E-145 to E-149,
Applicant North Western Industrial Zone, Port Qasim, Karachi."
Brand Name +Dosage Form + Strength GlipVil Tablets 50mg
Vidagliptin…50mg"
Type of Form Form-5
Me-too status Incriptin 50 mg Tablet of Martin Dow Ltd. Karachi
operating at satisfactory level of GMP Compliance at the time of

inspection.
Remarks of the Evaluator Reference product in approved as uncoated tablet but you have
applied for film coated tablet. Submit form 5, master
formulation & manufacturing method either in-line with
reference product along with requisite fee or evidence of
approval of applied drug product as film coated tablet.
o Applicant has revised the formulation from coated to uncoated
tablet with submission of Fee Rs. 5000/- Dated 0th May, 2019.
867. Name and address of manufacturer / "M/s Hiranis Pharmaceuticals (Pvt.) Ltd, Plot No. E-145 to E-149,
Brand Name +Dosage Form + Strength VilGlip-M Tablet 50/850
Composition "Each film coated Tablet contains:
Vildagliptin…50mg
Metformin HCl…850mg"
Type of Form Form-5
Me-too status Galmet 50mg/850mg Tablet of M/s Vision Pharmaceuticals.
868. Name and address of manufacturer / "M/s Kaizen Pharmaceuticals Pvt Ltd.
Applicant E-127-129, North Western Industrial Zone, Bin Qasim, Karachi"
Brand Name +Dosage Form + Strength Aripra Tablet 20mg
Aripiprazole …20mg"
Type of Form Form-5
Me-too status Apify 20mg Tablet of Akhai Karachi
Decision: Approved.
869. Name and address of manufacturer / "M/s Novamed Pharmaceuticals (Pvt) Ltd, 28-km,Ferozepur Road,
Applicant Lahore"
Brand Name +Dosage Form + Strength Pitava Tablet 2mg
Pitavastatin (as calcium)…2mg"
Pharmacological Group Anti-hyperlipidaemia
Type of Form Form-5
Finished product Specification Manufacturer‘s Specifications
Me-too status Pitalip Tablets 2mg of Hilton Karachi
operating at good level of GMP Compliance.
Decision: Approved with Japanese Pharmacopoeia specifications.
870. Name and address of manufacturer / "M/s Nova-Hemis Pharmaceuticals, Plot No. 154, Sector-23,
Applicant Korangi Industrial area. Karachi.
Brand Name +Dosage Form + Strength Cosiphen Syrup
Composition Each 5ml of syrup contains:
Aminophylline…. 32mg
Diphenhydramine hydrochloride….8mg
Ammonium Chloride…30mg
Menthol….. 0.98mg
Diary No. Date of R& I & fee Duplicate Dossier: Duplicate fee challan Rs. 20,000(25-05-17 )
Pharmacological Group Anti-Tussive
Type of Form Form-5
Approval status of product in Reference Could not be confirmed
Me-too status Broxol Syrup of Stanley Pharmaceuticals (Pvt) Ltd.
GMP status Panel Inspection for renewal of DML conducted on 28-02-19
recommends renewal of DML.
871. Name and address of manufacturer / "M/s Noa-Hemis Pharmaceuticals, Plot No. 154, Sector-23, Korangi
Applicant Industrial area. Karachi.
Brand Name +Dosage Form + Strength Cosiphen DM Syrup
Composition Each 5ml of syrup contains:
Diphenhydramine hydrochloride….5mg
Dextrometharphan Hydrobromide…. 6.25mg
Diary No. Date of R& I & fee Duplicate Dossier: Duplicate fee challan Rs. 20,000(23-05-17 )
Pharmacological Group Anti-Tussive
Type of Form Form-5
Me-too status Xatus D Syrup of Asian Continental (Pvt.) Ltd Karachi
GMP status Panel Inspection for renewal of DML conducted on 28-02-19
recommends renewal of DML.
872. Name and address of manufacturer / "M/s Genome Pharmaceuticals Pvt Ltd, Plot # 16/I-Phase IV,
Applicant Industrial Estate, Hattar, KPK
By M/s Aries Pharmaceuticals, 1-W, Industrial Estate, Hayatabad,
Peshawar, Khyber Pakhtunkhwa"
Brand Name +Dosage Form + Strength Livi 2.5mg tablet
Tibolone…2.5mg"
Diary No. Date of R& I & fee Dy.No 5558 dated 15-02-2018 Rs. 50,000/- Dated 15-02-2018
Pharmacological Group Estrogens
Type of Form Form-5
Finished product Specification BP Specifications
Me-too status Livial tablet of OBS (druginfosis)
Remarks of the Evaluator M/S. Aries Pharmaceuticals has submitted section approval
letter for tablet (hormone) section.
Decision: Approved. The Board further advised the manufacturer to get approval for steroidal hormone
section from Licensing Division before issuance of Registration letter.
Brand Name +Dosage Form + Strength Dinac Tablet 2mg/35mcg
Composition "Each film coated Tablet contains:
Cyproterone Acetate…2mg
Ethinyloestradiol…35mcg"
Type of Form Form-5
Me-too status Acne-Heal Tablet of OBS, Pak Karachi
Decision: Approved with innovator‘s specification. The Board further advised the manufacturer to get
approval for steroidal hormone section from Licensing Division before issuance of Registration letter.
Brand Name +Dosage Form + Strength Safe 10mg Tablets
Dydrogesterone…10mg"
Type of Form Form-5
Me-too status Danilon 10mg Tablet of Sami
Clarification regarding cis or trans form of Dydrogesterone.
Decision: Registration Board deferred the case for clarification regarding Specifications of applied drug
product as it is not present in BP.
By: Skims Pharmaceuticals, 10/B Value Addition city,
Khurrianwala, Faisalabad"
Brand Name +Dosage Form + Strength Levetram 100mg Syrup

Levetiracetam…100mg"
Type of Form Form-5
Me-too status Levixa 100mg/ml Oral Solution of High-Q Pharmaceuticals,
GMP status Verification of facility for grant of additional sections to M/S Skims
Pharmaceuticals conducted on 19-01-2018 concluded that firm is
operating at good level of CGMP compliance.
Remarks of the Evaluator M/s. Skims Pharmaceuticals has submitted section approval
letter for Oral Liquid General section.
Type of Primary Packaging material.
Decision: Registration Board deferred the case for clarification regarding Type of Primary Packaging
material of applied drug product.
876. Name and address of manufacturer / "M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 129, Sundar Industrial Estate, Raiwind Road, Lahore"
Brand Name +Dosage Form + Strength Presto 200mg Capsule
Fenofibrate…200mg"
Pharmacological Group LIPID MODIFYING AGENTS, PLAIN
Type of Form Form-5
Me-too status Tegex 200mg Capsule of Helix Pharmaceuticals Karachi
operating at good level of GMP Compliance
877. Name and address of manufacturer / "M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 129, Sundar Industrial Estate, Raiwind Road, Lahore"
Brand Name +Dosage Form + Strength Lozan Tablet 40mg
Composition "Each enteric coated tablets contains:
Pantoprazole (as sodium sesquihydrate)…40mg"
Pharmacological Group PPI
Type of Form Form-5
Me-too status Cantrofast Tablets 40mg of M/s Candid Pharmaceuticals
operating at good level of GMP Compliance
Decision: Approved with USP specification.

878. Name and address of manufacturer / "M/s Bloom Pharmaceuticals Pvt Ltd.
Applicant Plot # 30, Phase I & II, Industrial Estate, Hattar, Pakistan"
Brand Name +Dosage Form + Strength Blufen 200mg Suspension
Ibuprofen…200mg"
Type of Form Form-5
Pack size & Demanded Price 60ml, 90ml, 120ml: As per SRO
Me-too status Brofanic DSOral liquid suspension of M/s Regal Pharmaceuticals.
GMP status GMP Inspection conducted on 07-04-2018concluded that firm is
operating at satisfactory level of GMP Compliance.
Remarks of the Evaluator 2% overage
Decision:Deferred for justification on scientific grounds regarding addition of 2% overage in master

formulation.
879. Name and address of manufacturer / M/s. Scilife Pharma Plot No. FD-57/58-A2, Korangi Creek
Applicant Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Zoptra tablet 40mg
Composition Each delayed release tablet contains:
Pantoprazole (as sodium sesquihydrate)………40mg
Diary No. Date of R& I & fee Dy. No.3943; 24-05-2017; Rs.20,000/-
Pharmacological Group PPIs
Type of Form Form-5
Me-too status (with strength and dosage Cantrofast Tablets 40mg of Candid Pharmaceuticals,
form)
880. Name and address of manufacturer / M/s. Scilife Pharma Plot No. FD-57/58-A2, Korangi Creek
Applicant Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Zoptra tablet 20mg
Pantoprazole (as sodium sesquihydrate)………20mg
Diary No. Date of R& I & fee Dy. No.3943; 24-05-2017; Rs.20,000/-
Pharmacological Group PPIs
Type of Form Form-5
Me-too status (with strength and dosage Cantrofast Tablets 20mg of Candid Pharmaceuticals,
form)
881. Name and address of manufacturer / M/s Amson Vaccines & Pharma (Pvt) Ltd. Plot No. 154,
applicant Insdustrial Triangle, Kahuta Road, Islamabad Pakistan.

Brand Name + Dosage Form + Strength Osso-D Suspension 60ml / 120ml
Each 5ml Contains
Composition Ossien Minerl Complex (Microcystalline Hydroxyapatite
complex)…400mg + Vitamin D … 400IU
Diary No. Date of R&1 & fee Duplicate dossier
Pharmacological Group Minerals And Electrolytes
Type of Form Form-5
Finished product and specification AMSON SPECS
Pack size and demanded price 60ml /120ml in PET bottle/AS per policy of DRAP
Approval status of product in reference
--
regulatory authorities
Me too status Intig D Suspension SAMI Pharmacuticals
Remarks of the evaluator
882. Name and address of manufacturer / M/s Werrick Pharmaceuticals, 216-217, I-10/3, Industrial
Brand Name +Dosage Form + Strength IND-AIR Dry Powder Inhaler 150mcg
Diary No. Date of R& I & fee Diary No: 15331: 15-09-17; Rs: 20,000/-
Composition Each Rota capsule contains:
Indacaterol(as maleate)…. 150mcg
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form-5
Approval status of product in Approved in TGA
Me-too status Onbrez Breezhaler 150mcg Inhalation of Novartis Pharma
GMP status 17-01-2019: Grant of Section/Facility and Regularization.

Decision: Registration Board decided to defer the case for further deliberation.
Brand Name +Dosage Form + Strength BUD-AIR Dry Powder Inhaler 100/6mcg
Budesonide…. 100mcg
Formoterol fumarate….6mcg
Pharmacological Group Long acting beta-2-adrenoreceptor
agonists/Corticosteroid
Type of Form Form-5
Approval status of product in Approved in Canada (MHRA)
Me-too status Venticort Rotacaps 100mcg+6mcg Capsule of Macter
Intr.

Remarks of the Evaluator. Reference product is powder for inhalation which is
different from applied formulation i.e. Rota cap for
inhalation..
Brand Name +Dosage Form + Strength BUD-AIR Dry Powder Inhaler 400/6mcg
Budesonide…. 400mcg
Formoterol fumarate dihydrate….6mcg
Type of Form Form-5
Approval status of product in Approved in Canada (MHRA)
Me-too status Venticort Rotacaps 100mcg+6mcg Capsule of Macter Int.
Remarks of the Evaluator. Reference product is powder for inhalation which is

different from applied formulation i.e. Rota cap for
inhalation.
Brand Name +Dosage Form + Strength Oxytide-F Dry Powder Inhaler 50/100mcg
Salmeterol Xinafoate…. 50mcg
Fluticasone propionate….100mcg
Type of Form Form-5
Approval status of product in Approved in MHRA & TGA
Me-too status Seretide Accuhaler 50/100mcg of GSK
Remarks of the Evaluator. .

886.. Name and address of Manufacturer / M/s Welmark Pharmaceuticals
Applicant Contract manufactured by
M/s. Weatherfolds Pharmaceuticals
Brand Name+Dosage Form+Strength Stop 750 mcg tablet
Levenorgestral… 750mcg
Diary No. Date of R&I & fee DyNo.3977; 31-01-2018; Rs. 20000/-

Pharmacological Group Contraceptives
Type of Form Form-5
Me-too status Emkit of Zafa pharmaceuticals (drug infosis)
GMP status GMP inspection of M/S. weatherfold conducted on 15-09-
2017 concluded that firm is operating at satisfactory level
of GMP compliance.
Remarks of Evaluator Evidence of section approval is required.
which were adopted by Registration Board in its 275th meeting.
 Evidence of approval of required manufacturing facility for applied formulation.
b. DEFERRED CASES:
887. Name and address of Manufacturer / M/s Bio-Mark Pharmaceuticals
Applicant Plot No.527-Sunder Industrial Estate, Lahore
Brand Name+DosageForm+Strength Dopridone Oral Suspension 5mg
Domperidone…5mg
Diary No. Date of R&I & fee Duplicate Dossier : Photocopy Of Fee Challan Of Rupee
Rs.20,000/- Dated 05-07-17
Pharmacological Group Dopamine D2-receptor antagonist
Type of Form Form 5
Me-too status Epodom Suspension of Atlantic Pharmaceutical (Pvt) Ltd,
GMP status Certificate of cGMP is issued to the firm based on inspection
conducted on 16-08-2018 & is valid for a period of one year.
Remarks of Evaluator
Previous Decision Registration Board in its 287th meeting deferred the case for the
following:
For clarification of primary container closure system for applied
formulation.
Evaluation by PEC Firm has submitted following:
 Firm opted for amber glass bottle for the applied
formulation.
 Fee challan of Rupee 5000/- dated, 22-03-19.
888. Name and address of manufacturer / M/s Wilshire Laboratories (Pvt) Ltd. 124/1, Quid-e-azam
Applicant Industrial Estate, Kot Lakhpat, Lahore.
Brand Name +Dosage Form+ Strength Namsal Injection 0.009g/ml

Sodium Chloride…. 0.009gm
Type of Form Form-5
Pack size & Demanded Price 40ml,50ml,100ml ; As per SRO
Approval status of product in Approved in US-FDA
Me-too status Flow NS IV Infusion Injectable of Mediflow (100ml)
GMP status GMP inspection conducted on 18-05-2017 with conclusive
remarks that firm is operating at satisfactory level of GMP
compliance.
Remarks of the Evaluator. Separate application for each volume.
Mention type of primary packaging material.
(Applicant has selected the filled volume ―100ml‖ & type I glass
as container closure system).
Previous Decision Registration Board in its 283rd meeting deferred the case for the
following:
Deferred for confirmation whether manufacturing facility of
Liquid injectables is approved for ― Small Volume Parenterals‖
or ― Large Volume Parenterals‖
Evaluation by PEC:
Firm has replied as follow:
Please note that we already hold registration of our different liquid injections with different pack sizes
including 1ml, 3ml, 50ml,100ml, 250ml, 300ml, for your ready reference following documents are
attached:
 Approval of our liquid Injection section.
 Registration letter issued by Ministry of Health for our products (Adios, Neumo, & Quash) with
pack sizes of 100ml & 50ml.
 Registration Letter issued by DRAP for our product Palzic Injection with 250ml pack size.
 Registration Letter issued by DRAP for our Product Volinza Injection with 300ml pack size.
 Registration Letter issued by DRAP for our Product Zwitter Injection with 3ml pack size.
 Registration Letter issued by DRAP for our Product Xyster Injection with 1ml pack size.
Sr. Reply of the Firm Evaluation by PEC:
No.
1 Approval of our liquid Injection section. Applicant has submitted photocopy of Letter of CLB
bearing a number No.F.1-65/84- Lic(Vol-II)(M-227)
2 Registration letter issued by Ministry of Applicant has submitted Photocopy of Registration
Health for our products (Adios, Neumo, Letter dated 16th of March 2004, for Adios Injection
& Quash) with pack sizes of 100ml & (100ml), Neumo Injection (100ml), Quash Injection
50ml. (50ml, 100ml).
3 Registration Letter issued by DRAP for Firm has submitted Photocopy of Registration Letter
our product Palzic Injection with 250ml dated 09th of May 2017, for Palzic Injection (250ml).
pack size.
our Product Volinza Injection with dated 08th of January 2018, for Volinza Injection
300ml pack size. (300ml).
our Product Zwitter Injection with 3ml dated 24th of October 2017, for Zwitter Injection
pack size. (3ml).
our Product Xyster Injection with 1ml dated 18th of August 2011, for Zyster Injection (1ml).
pack size.
Decision: Registration Board decided to defer the case for clarification regarding approval of
required manufacturing facility & equipment for applied drug product from Licensing Divisions.
Brand Name+Dosage Form + Strength Namsal Injection 0.009g/ml

Type of Form Form-5
Pack size & Demanded Price 2ml,5ml; As per SRO
Me-too status Engsol Injection 0.90% w/v of English pharma(5ml)
Remarks of the Evaluator. Separate application for each applied volume.

following:
Evaluation by PEC:
attached:
 Registration Letter issued by DRAP for our Product Xyster Injection with 1ml pack size.
Decision: Registration Board decided to defer the case for clarification regarding approval of
required manufacturing facility& equipment for applied drug product from Licensing Divisions.
Brand Name+Dosage Form + Strength Namsal Injection 0.009g/ml
Type of Form Form-5
Pack size & Demanded Price 10ml,20ml; As per SRO
Me-too status Engsol Injection 0.90% w/v of English Pharma(10ml)
compliance.
Remarks of the Evaluator. Separate application for each applied volume.
following:

Evaluation by PEC:
attached:
 Registration Letter issued by DRAP for our Product Xyster Injection with 1ml pack size
Decision:Registration Board decided to defer the case for clarification regarding approval of
required manufacturing facility& equipment for applied drug product from Licensing Divisions.
891. Name and address of Manufacturer / M/s. Danas Pharmaceuticals, 312, industrial triangle,
Applicant Kahuta Road, Islamabad.
Brand Name+DosageForm+Strength Pequine tablets 75mg
Quetiapine (as fumarate)….75 mg
Diary No. Date of R&I & fee DyNo.9095; 18-07-2017; Rs. 20000/-
Type of Form Form-5
Pack Size & Demanded Price 3×10‘s; As per SRO
Approval status of product in Not submitted
Me-too status Not submitted
GMP status Certificate of GMP is issued to the firm based on inspection
conducted on 03-10-2017 valid for a period of one year.
Remarks of Evaluator Firm has claimed Manufacturer specifications but the applied
formulation exist in USP.
Firm has submitted that 75mg is a typographical error, kindly
read the strength as 25mg instead of 75mg as 75mg is not
available in reference agencies, hence corrected strength is
25mg.
Previous Decision Registration Board in its meeting deferred the case for
Submission of fee for revision of formulation.
Evaluation by PEC Applicant has submitted Fee challan of Rupee 5000/- dated 25-
Decision: Registration Board decided to reject the applied drug product after taking the history of
case into account.
892. Name and address of manufacturer / M/s. Danas Pharmaceuticals, 312, industrial triangle,
Brand Name+Dosage Form + Strength Sidik tablet 250mg
Sodium fusidate…. 250mg
Type of Form Form-5
Pack size & Demanded Price 2×10‘s ; As per SRO
Approval status of product in Approved in MHRA(uncoated tablet)
Me-too status Fucidin of LEO Pharm
GMP status Certificate of GMP is issued to the firm based on inspection
conducted on 03-10-2017 valid for a period of one year.
Remarks of the Evaluator Applicant has revised the formulation from film coated to
uncoated tablet, which is in line with reference product without
submission of fee.
Previous Decision Registration Board in its meeting deferred the case for
submission of fee for revision of formulation from Sodium
fusidate 250mg film coated tablet to Sodium fusidate 250mg
uncoated tablet.
Evaluation by PEC Applicant has submitted Fee challan of Rupee 5000/- dated 07-
Decision: Deferred for evidence of approval of required manufacturing facility as the applied drug
product is a steroidal medication.
893. Name and address of Manufacturer / M/s. Searle IV infusion, 1.5 km Raiwind Road, Manga Mandi
Applicant Lahore
Brand Name+Dosage Form+Strength Tenorains 300mg Tablet
Composition Tenofovir disproxil fumarate….300mg
Diary No. Date of R&I & fee Dy.No.8939; 17-07-2017; Rs. 20,000/-
Pharmacological Group Nucleoside reverse transcriptase inhibitors
Type of Form Form-5
Pack Size & Demanded Price 30‘s ; Rs.3450/- or As per SRO
Me-too status Viread 300mg tablet of Ferozsons laboratories limited
remarks that firm is GMP compliant
Previous decision Registration board in its 283rd meeting deferred the case for the
correction of label claim as per reference product.
Evaluation by PEC Applicant has submitted that the label claim of applied drug
product is same to that of reference product.
Decision: Approved with international Pharmacopoeia Specifications.
Case no. 02 Registration Applications of Newly Granted DML or New Section (Human).
a. New/Additional Section(s)& Remaining Molecules (if any).
Lyophilized Vials Injectable (General):
Previously considered Molecules; 08(M-275, M-288)
Now applied: Molecules: 01 Products: 03
894. Name and address of Manufacturer / M/s MTI Medical Pvt Ltd.
Applicant 586-587, Sundar Industrial Estate, Lahore, Pakistan"
Brand Name + Dosage Form + Strength Colimate Lyophilized 500,0000 IU Injection
Colistimethate Sodium…500,0000 IU"
Diary No. Date of R&I & fee Dy.No 18442 dated 21-05-2018 Rs.20,000/- 21-05-2018
Type of Form Form-5
Pack Size & Demanded Price 1‘s:As per SRO

GMP status NEW SECTION (Letter Issuance date: 11th April, 2017)
Lyophilized Vials Injectables(general)
Remarks of Evaluator Type of primary packaging material.
 For evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board in its 275 th
meeting.
 For evidence of applied formulation/ drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm.
 For clarification regarding Type of primary packaging material for applied drug product.
Type of Form Form-5
Decision:Deferred for submission of stability studies both accelerated & real time for six month as
per guidelines approved & reviewed by registration board in its 251 st& 278th meeting respectively.
Type of Form Form-5
Me-too status Colistat powder for Injection of Medisure Lab. Karachi.
Decision:Approved.
Dry powder Injectable (General):
Previously considered Molecules; 08 (M-275, M-288)
Name and address of Manufacturer / "M/s Horizon Healthcare (Pvt) Ltd.
Applicant Plot No. 33, Sundar Industrial Estate, Lahore"
Brand Name + Dosage Form + Strength Tigezon 50mg Injection
897. Composition "Each Vial Contains:
Tigecycline Lyophilized Powder…50mg"
Diary No. Date of R&I & fee Duplicate dossier Rs.20,000/- (duplicate dossier)
Type of Form Form-5
Pack Size & Demanded Price 1‘s, 5‘s, 10‘s :As per SRO
Me-too status Tilane 50mg Injection of S.J&G Karachi .
Decision:Registration Board deferred the case wheather it has to considered on priority as the
firm has changed his nomenclature from Wellness Pharmaceuticals to Horizon Healthcare (Pvt)
Ltd.
b. Deferred Cases New DML/New Section(s).

898. Name and address of manufacturer/ M/s Saffron Pharmaceutical 19 km, Sheikhupura Road,
Applicant Faisalabad.
Brand Name +Dosage Form+Strength Karit DrySuspension125mg/5ml
Diary No. Date of R&I &fee DiaryNo:34120; 15/10/2018; Rs:20,000/-
Composition Each 5ml(when reconstituted)contains:
Clarithromycin …125mg
(granules for oral suspension)
Pharmacological Group Antibiotic(Macrolide)
Type of Form Form-5

Pack size &Demanded Price 30ml,50ml,60ml/As perSRO
Approval status of production Biaxin granules for oral suspension 125mg/5mlbyM/s
Reference Regulatory Authorities. Abbvie, USFDA approved.
Me-too status Klarim Dry Suspension 125mg/5ml of Amrose Pharma
GMP status New Section (Letter Issuance date: )
Remarks of the Evaluator. Mention type of primary packaging material of applied
formulation.
 (Firm has mentioned amber glass bottle as container
closure system for applied formulation)
Firm is using imported granules for which following things are
required:
 GMP of pellets manufacturer and stability studies of
three batches of pellets conducted in accordance with
zone IV-A conditions.
 Differential fee Of Rupee 80,000/- required in case of
imported pellets.
Previous Decision: Registration Board in its 287th meeting deferred the case
For source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of import of
pellets.
Evaluation By PEC Firm has submitted fee challan of Rupee 80,000/- dated 01-03-
2019 & stability studies in accordance with zone IVA conditions
& GMP certificate of Zheijiang Zhongtong Pharmaceuticals.
Decision: Approved.
899. Name and address of manufacturer/ M/s Saffron Pharmaceutical 19 km, Sheikhupura Road,
Applicant Faisalabad.
Brand Name +Dosage Form+Strength Karit DrySuspension250mg/5ml
Diary No. Date of R&I &fee DiaryNo:34121; 15/10/2018; Rs:20,000/-
Composition Each 5ml(when reconstituted)contains:
Clarithromycin …250mg
(granules for oral suspension)
Pharmacological Group Antibiotic(Macrolide)
Type of Form Form-5
Pack size &Demanded Price 30ml, 60ml; Rs. 400/-, Rs. 600/-
Approval status of production Approved in MHRA
Me-too status Rethro 250mg /5ml of M/s Regal Pharmaceuticals
GMP status New Section (Letter Issuance date: )
Remarks of the Evaluator. Mention type of primary packaging material of applied
formulation.
 (Firm has mentioned amber glass bottle as container
closure system for applied formulation)
Firm is using imported granules for which following things are
required:
 GMP of pellets manufacturer and stability studies of
three batches of pellets conducted in accordance with
zone IV-A conditions.
Differential fee of Rs.80,000/- required in case of
imported pellets
Previous Decision: Registration Board in its 287th meeting deferred the case
For source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of import of
pellets.
Evaluation By PEC Firm has submitted fee challan of Rupee 80,000/- dated 01-03-
2019 & stability studies in accordance with zone IVA
conditions & GMP certificate of Zheijiang Zhongtong
Pharmaceuticals.
Decision: Approved.
Case No. 03: Registration Applications for Local Manufacturing of (Veterinary) Drugs.
a. New Cases.
900. Name and address of manufacturer / "M/s Nawal Pahrmaceuticals, Plot No. 11-A, Punjab Small
Applicant Industrial Estate,Taxila"
Brand Name +Dosage Form + Strength Cina-Wal Liquid
Enrofloxacin…75mg
Sulphamethoxypiridazine…75mg
Sulphamethazine…50mg
Trimethoprim…25mg"
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ML, 500ml: Decontrolled
Approval status of product in Reference -
Me-too status Cina T.S Oral Suspension of M/S. Vety-Care, Rawalpindi
GMP status GMP Inspection conducted on 29-10-2018 concluded that
firm is compliant to current Good manufacturing
requirements with the need of some improvements which
have been discussed and agreed with the management.
Decision: Referred to expert group on veterinary drugs.
901. Name and address of manufacturer / "M/s Nawal Pahrmaceuticals.
Applicant Plot No. 11-A, Punjab Small Industrial Estate,Taxila"
Brand Name +Dosage Form + Strength Fen-Wal Liquid
Florfenicol…25g
Colistin Sulphate…50 MIU"
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ML, 500ml, 1Litre, 2.5Litre:
Decontrolled
Me-too status Flocol Liquid of M/s. D-maarson pharmaceuticals
Decision:Approved with Innovator‘s Specifications.
Brand Name +Dosage Form + Strength Neo-Flox Powder
Composition "Each gm contains:
Oxytetracycline hydrochloride…300mg
Florfenicol…100mg
Neomycin sulphate…150mg"
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 10kg, 25kg: Decontrolled
Me-too status E-Col of M/s. Evergreen (Reg.#081733) (From M-286th RB)
Decision: Approved with Innovator‘s Specifications.
Brand Name +Dosage Form + Strength Amar-Wal 98% Powder
Composition "Each 100g contains:
Amantadine hydrochloride…98g"
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 10kg, 25kg: Decontrolled
Me-too status Amantadine hydrochloride powder of M/s Evergreen (Reg.#
081735) (From M-285th RB)

Brand Name +Dosage Form + Strength Tylo-Wal Powder
Tylosin Tartrate…980mg"
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 5kg, 10kg, 25kg: Decontrolled
Me-too status Tylotar-98 of M/s. Evergreen Reg. #081736 (From M-285th
RB)
Remarks of the Evaluator Evidence of applied formulation/drug already approved by

number, brand name and name of firm, as the provided me-
too is not verifiable.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm, as the provided
me-too is not verifiable.
Brand Name +Dosage Form + Strength Wal-Fen 25% Liquid
Florfenicol…25g"
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1litre, 2.5litre: Decontrolled
Me-too status Florfenicol Oral Liquid of M/S. Attabak Pharmaceuticals,
Islamabad.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm, as the provided
me-too is not verifiable.
Brand Name +Dosage Form + Strength Fenicol Oral Liquid
Florfenicol…10g
Colistin sulphate…. 50MIU
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1litre, 2.5litre: Decontrolled
Me-too status Floro-C Oral Liquid Of M/S. D-Maarson Pharmaceuticals
907. Name and address of manufacturer / "M/s Farm Aid Group, Plot # 3/2, Phase I & II, Hattar
Applicant Industrial Estate, Haripur, KPK"
Brand Name +Dosage Form + Strength LC 10 Powder
Composition "Each 100gm powder contains:
Lincomycin HCl …9gm
Colistin Sulphate …80,000,000 IU."
Type of Form Form-5
Pack size & Demanded Price 10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500gm,1kg,
5kg,10kg,15kg,20kg, 25kg: Decontrolled
Me-too status LC-100 Oral Powder Of M/S. Ras Pharma, Multan
GMP status GMP Inspection conducted on 07-09-2017concluded as
follows:
Observations/ Recommendations:
"1- Improve quality assurance system as per GMP
guidelines.
2- Develop annual product review system for marketed
products.
Overall firm was working under satisfactory level of GMP."
908. Name and address of manufacturer / "M/s Farm Aid Group, Plot # 3/2, Phase I & II, Hattar
Applicant Industrial Estate, Haripur, Kpk"
Brand Name +Dosage Form + Strength LS Mox Powder
Composition "Each 100gm powder contains:
Amoxicillin Trihydrate…20gm
Lincomycin HCl…9gm
Spectinomycin 2HCl…8.8gm"
Type of Form Form-5
Finished product Specification Innovators Specifications
Pack size & Demanded Price 10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500gm,1kg,
5kg,10kg,15kg,20kg, 25kg: Decontrolled
Me-too status LC-100 Oral Powder Of M/S. Ras Pharma, Multan
Remarks of the Evaluator Approval of section/manufacturing facility by the Central
Licensing Board. However, you may submit panel
inspection report for renewal of DML verifying the
section/manufacturing facility.
Evaluation by PEC:
On recommendation of panel of experts, The CLB in its
253rd meeting held on May 15th-16th, 2017 has considered
and approved the grant of Dry Penicillin Powder
section(vet).
Brand Name +Dosage Form + Strength Linco-Wal Powder (water soluble)
Lincomycin hydrochloride…100mg
Colistin Sulphate…800,000 IU"
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 5kg, 10kg, 25kg: Decontrolled
Me-too status Colimycin Water Soluble Powder of Attabak
Pharmaceutical Islamabad.
GMP status GMP Inspection conducted on 29-10-2018 concluded that
firm is compliant to current Good manufacturing
requirements with the need of some improvements which
have been discussed and agreed with the management.
Brand Name +Dosage Form + Strength Doxy-50 Powder (water soluble)
Doxycycline HCl …500mg"
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 5kg, 10kg, 25kg:Decontrolled
Me-too status Doxybak Powder of Attabak Pharmaceuticals Islamabad.
(Each 100g Contain:
Doxycycline HCl …….50gm)
Brand Name +Dosage Form + Strength T-Dox Powder (water soluble)
Composition "Each 100gm contains:
Doxycycline HCl …40mg
Tylosin tartrate …20g"
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 5kg, 10kg, 25kg:Decontrolled
Me-too status Dot Powder of Attabak Pharmaceutical, Islamabad.
Brand Name +Dosage Form + Strength Waltin Liquid (oral liquid)
Enrofloxacin …10g
Colistin Sulphate …50 MIU"
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1litre:Decontrolled
Me-too status Enrotin solution of Attabak pharma Islamabad
Brand Name +Dosage Form + Strength Menbro-60 Liquid (oral liquid)
Bromhexine HCl …50mg
Menthol …40mg"
Type of Form Form-5
Me-too status Broman of D-Maarson (not verifiable)
Remarks of the Evaluator Evidence of approval of applied formulation in reference
Brand Name +Dosage Form + Strength Enro-Mix Liquid (oral liquid)
Enrofloxacin…20gm
Colistin Sulphate…50 MIU"
Type of Form Form-5
Me-too status Floxa-C Oral Solution Of "Baariq Pharmaceuticals,
915. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Applicant Industrial Area, 20th km Ferozepur Road, Lahore"
Brand Name +Dosage Form + Strength Ever-Coc Water Soluble Powder
Composition "Each gm Contains:
Amprollium hydrochloride…200mg
Furaltadon hydrochloride …200mg
Vitamin K3…5mg"
Pharmacological Group Antibiotics/antibacterial
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1kg, 5kg,10kg, 25kg : Decontrolled
Me-too status Wealcoc Powder Of M/S. Mallard Pharmaceutical, Multan
GMP status Panel Inspection conducted on 03-01-2018 for renewal of
DML recommended renewal of DML.
Sr. Remarks of the Evaluator Reply of the firm
No.
1 Approval of section/manufacturing facility by Firm has Panel Inspection report for
the Central Licensing Board. However, you may renewal of DML confirming liquid Oral
submit panel inspection report for renewal of (veterinary) & Dry Powder General section.
DML verifying the section/manufacturing *Dry powder general section does not
facility. contain the world veterinary with it.
Decision:Registration Board decided to reject the applied drug product as Furaltadon
hydrochloride is banned in many countries including EMA for use in livestock owing to its
carcinogenic effects on humans.
916. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo Town,
Applicant Industrial Area, 20th km Ferozepur Road, Lahore"
Brand Name +Dosage Form + Strength Terivet Plus Oral Suspension
Trimethoprim............…80mg
Sulfadiazine….............400mg
Type of Form Form-5
Approval status of product in Reference -
Me-too status Sulzine oral suspension of ISIS Pharmaceuticals.
GMP status Panel Inspection conducted on 03-01-2018 for renewal of
DML recommended renewal of DML.
Sr. Remarks of the Evaluator Reply of the firm
No
1 Approval of section/manufacturing facility by Firm has Panel Inspection report for renewal
the Central Licensing Board. However, you of DML confirming liquid Oral (veterinary)
may submit panel inspection report for renewal & Dry Powder General Section.
of DML verifying the section/manufacturing *Dry powder general section does not
facility. contain the world veterinary with it.
Decision: Approved with innovator‘s Specifications.
917. Name and address of Manufacturer / M/s A & K Pharmaceuticals, 94-A, Punjab Small Industrial
Applicant Estate, Faisalabad.
Brand Name + Dosage Form + Strength Colmox-20 Powder (Oral Powder)
Composition Each Kg contains:
Amoxicillin trihydrate….....0.2kg
Colistin sulphate….............0.06kg
Pharmacological Group Penicillin Antibiotic, Polymyxin Antibiotic
Type of Form Form-5
Pack Size & Demanded Price 28g, 100g Alu sachet

250g, 450g,500g,100g plastic jars
5kg,25kg Polythene bag:
Decontrolled
Me-too status Technolan Water Soluble Powder of Vetworld Animal Health
Company, Rawalpindi (500gm, 1000gm.)
GMP status Panel Inspection for Renewal of DML conducted on 09-11-
2018 recommends renewal of DML bearing No. 000534 &
grant of Bolus section in favour of M/s. A&K
Pharmaceuticals & does not recommend Oral dry Powder
(Penicillin) at present.
Sr. Remarks of Evaluator: Reply By the Firm.
No.
1. Approval of section/manufacturing facility Our Penicillin Section for oral powders is
(Penicillin dedicated facility) by the Central under approval. When it will be approved we
Licensing Board. However, you may submit will submit the approval report.
panel inspection report for renewal of DML  Applied formulation contains Penicillin
verifying the section/manufacturing facility. antibiotic in it.
2. Submit quantity per grams for both APIs of Each gram contains:
applied formulation; furthermore submit Amoxicillin trihydrate… 200mg.
quantity of Colistin sulphate in international Colistin sulphate….1200000IU.
(IU) units as well.
Decision: Registration Board decided to reject the applied formulation as firm don‘t have required
manufacturing facility for applied drug Product.
Brand Name + Dosage Form + Strength Levanew-400 Bolus (Oral Bolus)
Composition Each bolus contains:
Levamisol hydrochloride…. 0.4g
Type of Form Form-5
Pack Size & Demanded Price 5‘s, 10‘s, 20‘s, 50‘s, 100‘s,: Decontrolled
Me-too status Leva 400 Bolus of Intervac (Pvt) Ltd
(5 Bolus,10 Bolus,20 Bolus,50 Bolus)
Sr.# Remarks of Evaluator Reply of the firm
1 Approval of section/manufacturing facility Panel Inspection for Renewal of DML conducted
by the Central Licensing Board. However, on 09-11-2018 recommends renewal of DML
you may submit panel inspection report for bearing No. 000534 &grant of Bolus section in
renewal of DML verifying the favour of M/s. A&K Pharmaceuticals & does not
section/manufacturing facility. recommend Oral dry Powder (Penicillin) at present.
Decision: Deferred for evidence of approval of required manufacturing facility for applied
formulation.
Levamisol hydrochloride…. 0.6g(600mg)
Type of Form Form-5
Me-too status VERNIL-600 Bolus of Star Laboratories Lahore (5 Bolus,10
Bolus, 50 Bolus)
Sr. Remarks of Evaluator Reply of the firm
No.
1 Approval of section/manufacturing facility Panel Inspection for Renewal of DML conducted on
by the Central Licensing Board. However, 09-11-2018 recommends renewal of DML bearing
you may submit panel inspection report No. 000534 & grant of Bolus section in favour of
for renewal of DML verifying the M/s. A&K Pharmaceuticals & does not recommend
section/manufacturing facility. Oral dry Powder (Penicillin) at present.
formulation.
Levamisol hydrochloride…. 1.125g(1125mg)
Type of Form Form-5
Me-too status Primisol 1125 Bolus of Prix Pharmaceutica (Pvt) Ltd., Lahore
(20‘s, 50‘s)
Sr.# Remarks of Evaluator Reply of the firm
1 Approval of section/manufacturing facility Panel Inspection for Renewal of DML
by the Central Licensing Board. However, conducted on 09-11-2018 recommends renewal
you may submit panel inspection report for of DML bearing No. 000534 &grant of Bolus
renewal of DML verifying the section in favour of M/s. A&K Pharmaceuticals
section/manufacturing facility. & does not recommend Oral dry Powder
(Penicillin) at present.
Decision:Deferred for evidence of approval of required manufacturing facility for applied
formulation.
Brand Name + Dosage Form + Strength Milko-Plus Minerals (Oral)
Calcium…155 grams
Phosphorus…135 grams
Magnesium…55 grams
Sodium…45 grams
Iron…1 grams
Zinc…3 grams
Manganese…2 grams
Copper…0.6 grams
Cobalt…0.01 grams
Iodine…0.04 grams
Selenium…0.003 grams
Type of Form Form-5
Pack Size & Demanded Price 1kg,5kg,10kg,25kg: Decontrolled
Me-too status L.S.Minerals Powder of Nawan Labs Karachi
Sr. Remarks of Evaluator: Reply of the Firm
No
1. Approval of section/manufacturing facility by Panel Inspection for Renewal of DML
the Central Licensing Board. However, you conducted on 09-11-2018 recommends
may submit panel inspection report for renewal of DML bearing No. 000534 &grant
renewal of DML verifying the of Bolus section in favour of M/s. A&K
section/manufacturing facility. Pharmaceuticals & does not recommend Oral
dry Powder (Penicillin) at present.
2. Evidence of applied formulation/drug already SP minerals Granules by7 Selmore Pharma,
approved by DRAP (generic / me-too status) Lahore. Reg # 088154.
alongwith registration number, brand name
and name of firm as provided me too does not  Needs verification.
contain one of the ingredients of applied
formulation i.e. ―selenium‖ in it.
formulation.
Brand Name + Dosage Form + Strength Milko-gold Minerals (Oral)
Vitamin A…0.8 grams
Vitamin D3…0.16 grams
Vitamin E…0.38 grams
Vitamin B2…1.25 grams
Copper Sulphate…0.25 grams
Magnesium Sulphate…25 grams
Calcium Chloride…0.023 grams
Zinc Sulphate…2.17 grams
Maganese Sulphate…10 grams
Potassium Iodide…0.5 grams
Sodium Selenite…0.01 grams
Dibasic Calcium Phosphate…150 grams
Sodium Chloride…120 grams
Type of Form Form-5
Pack Size & Demanded Price 1kg,5kg,10kg,25kg(bags): Decontrolled
Me-too status White Gold Powder of Leads Pharma (Pvt) Ltd.
Sr. Remarks of Evaluator Reply of the firm
No
.
1 Approval of section/manufacturing facility Panel Inspection for Renewal of DML
by the Central Licensing Board. However, conducted on 09-11-2018 recommends
you may submit panel inspection report for renewal of DML bearing No. 000534 & grant
renewal of DML verifying the of Bolus section in favour of M/s. A&K
section/manufacturing facility. Pharmaceuticals & does not recommend Oral
dry Powder (Penicillin) at present.
2 Evidence of applied formulation/drug Some other ingredients were added
already approved by DRAP (generic / me- additionally like Vitamin B1 & vitamin B6 in
too status) alongwith registration number, the given Me too status after our application
brand name and name of firm as provided for registration of drug. However we are
me too contains some other ingredients in interested in the same formulation as follow:
it. Me Too: White Gold Powder of Leads
Pharma
Reg No. 058842
 Evidence of approval of required manufacturing facility for applied formulation.
Case No. 04: Registration Applications of Categories to be Considered on Priority.

a. Import applications of priority categories defined by Registration Board in its
257th meeting
i. Human
923. Name and address of Applicant Genix Pharma (Pvt) ltd. 44, 45-B Korangi Creek Road, Karachi,
75190, Pakistan.
Detail of Drug Sale License Address: Genix Pharma (Pvt) ltd. 44, 45-B Korangi Creek Road,
Karachi, 75190, Pakistan.
Status: Drug License by way of Wholesale
Name and address of Yichang Humanwell Pharmaceutical Co., Ltd., No. 19 of Dallan
manufacturer road, Yichange Developing Zone, Hubei Province, China.
Name and address of marketing Yichang Humanwell Pharmaceutical Co., Ltd., No. 19 of Dallan
authorization holder road, Yichange Developing Zone, Hubei Province, China.
Diary No. & Date of R& I Dy. No.15723 Dated 27/04/2018
Brand Name +Dosage Form + Refent Injection 1mg
Strength
Remifentanil hydrochloride….1mg
(freeze-dried powder for injection)
Finished Product Specification Innovator‘s specifications
Shelf life 2 years
Pack size 5‘s: As Per SRO
International availability Approved in US-FDA
Me-too status N/A
Detail of certificates attached Origional legalized CoPP:
Certificate No: 20170063

Certified by: Hubei Food & Drug Administration No. 19
Gongzheng Road Wu Chang District, Wuhan City, China.
Issued date: 18/12/2017
Free sale in exporting country: Confirms the free sale of the
product in exporting country.
GMP: The facilities and operations conform to GMP as
recommended by WHO as per CoPP.
legalized Free sale Certificate:
Certificate No: 2017-63
Certified by: Hubei Food & Drug Administration.
Validity: 2years
legalized GMPCertificate:
Certificate No: HB20170318
Certified by: Hubei Province Food & Drug Administration.
Validity: valid until 03-02-2022
Letter of authorization:
Genix Pharma (Pvt) ltd & Yichang Humanwell Pharmaceutical.
Remarks of the Evaluator. Submit stability Studies both accelerated & real time of three
batches of applied formulation as per Zone VI-A conditions as
submitted stability studies are not according to Zone IVa
conditions.
(Applicant has submitted that Product is unstable at 30C it has
to be stored between 2- 25C) they have submitted stability
study data at following conditions:
Real Time: 25oC ± 2oC / 60% ± 5%RH
For clarification regarding storage conditions of Innovator product.
For submission of stability study data both accelerated & real time for two more batches of
applied drug product as stability studies data for only one batch is submitted.

924. Name and address of Applicant M/s We Care (Revolution in Health care) House No. 275 Street
No.55 Sector I-8/3, Islamabad.
Detail of Drug Sale License Address: Flat No B-6, 2nd Floor, Block D-12, Sector G-8, Markaz
Islamabad.
Status: Licence To Sell Drugs In A Whole Sale Distribution.
Name and address of M/s Shenzhen South China Pharmaceutical (NCPC) Co., Ltd.
manufacturer D Building No. 2, Industrial Park Of Xiashijia, Jiangshi,
District: Gongming Town.,Guangming New Zone, Shenzhen, P.R.
China
Name and address of marketing M/s SinoPharm International Co., Ltd. Building 12, No. 899, Zu
authorization holder Chongzhi Rd., Zhangjiang Hi-Tech Park, Pudong District, Shanghai,
201203, China.
Fee including differential fee Rs. 100,000/-
Brand Name +Dosage Form + Biopenem Injection
Strength
Meropenem for Injection… 0.5gm (500mg)
Demanded Price De-Controlled
Pack size 1gm, 500gm, 1kg
Me-too status Xepime 0.5gm Injection IV Each vial contains:- Meropenem (as
Trihydrate)…0.5gm of Macter International (Pvt) Ltd , Karachi
Detail of certificates attached Original legalized GMP Certificate:
Certificate No. GD20170711
Certified by: China Food & Drug Administration
Original Legalised Letter of authorization
M/s We Care & M/s Shenzhen North China
Validity:.
Sr. Remarks of the Evaluator: Reply of the firm
No.
1 Explain the difference of Name of
Manufacturer on Letter of Authorization
i.e. Shenzhen North China & on Form 5
Shenzhen South China.
2 Reference product is approved as Firm has claimed it as meropenem (as
meropenem (as trihydrate) 0.5gm Powder trihydrate) 0.5gm injection.
for Injection or Infusion which is different
from applied formulation i.e. meropenem
0.5gm Powder for Injection or infusion.
Clarify/ Justify.
3 Mention type of primary packaging Type I glass
material of applied formulation whether it
is Type I, Type II & Type III glass
container.
4 Submit copy of valid DSL of the applicant. Applicant has submitted DSL with Following
Information:
Address: Flat No B-6, 2nd Floor, Block D-12,
Sector G-8, Markaz Islamabad.
Status: Licence To Sell Drugs In A Whole
Sale Distribution
Decision: Approved.
925. Name and address of Applicant M/s We Care (Revolution in Health care) House No. 275 Street
No.55 Sector I-8/3, Islamabad.
Detail of Drug Sale License Address: Flat No B-6, 2nd Floor, Block D-12, Sector G-8, Markaz
Islamabad.
Status: Licence To Sell Drugs In A Whole Sale Distribution
Name and address of M/s Shenzhen South China Pharmaceutical (NCPC) Co., Ltd.
manufacturer D Building No. 2, Industrial Park Of Xiashijia, Jiangshi,
District: Gongming Town.,Guangming New Zone, Shenzhen, P.R.

China
Name and address of marketing M/s SinoPharm International Co., Ltd. Building 12, No. 899, Zu
authorization holder Chongzhi Rd., Zhangjiang Hi-Tech Park, Pudong District, Shanghai,
201203, China.
Brand Name +Dosage Form + Biopenem Injection
Strength
Meropenem for Injection… 1gm (1000mg)
Shelf life 24months (Stability studies submitted according to Zone IVA
conditions)
Pack size
Me-too status Xepime 1gm Injection IV Each vial contains:- Meropenem (as
Trihydrate)…1gm of Macter International (Pvt) Ltd , Karachi
Detail of certificates attached Copy of Original legalized GMP Certificate:
( for Meropenem 0.5gm Injection)
Certificate No. GD20170711
Original Legalised Letter of authorization
M/s We Care & M/s Shenzhen North China
Validity:
Sr.# Remarks of the Evaluator Reply of the firm
1 Explain the difference of Name of Manufacturer on
Letter of Authorization i.e. Shenzhen North China &
on Form 5 Shenzhen South China.
2 Reference product is approved as meropenem (as Firm has claimed it as meropenem
trihydrate) 1gm Powder for Injection or Infusion (as trihydrate) 0.5gm injection.
which is different from applied formulation i.e.
meropenem 1gm Powder for Injection or infusion.
Clarify/Justify.
3 Mention type of primary packaging material of Type I glass
applied formulation whether it is Type I, Type II &
Type III glass container.
4 Submit Original legalized GMP Certificate & Free Firm submitted legalized COA
sale Certificate or Original legalized COPP, for the instaed of COPP.
applied strength i.e. ― meropenem 1gm powder for
injection or Infusion‖. Of applied formulation as
attached documents are of another strength.
5 Submit copy of valid DSL of the applicant. Applicant has submitted DSL with
Following Information:
Address: Flat No B-6, 2nd Floor,
Block D-12, Sector G-8, Markaz
Islamabad.
Status: Licence To Sell Drugs In A
Whole Sale Distribution
Decision: Deferred for submission of Original Legalized COPP for applied drug product.
926. Name and address of Applicant M/s Network Marketing Services,
14C (Commercial) P.C.H.S., Defence Road, Lahore.
Detail of Drug Sale License Address:
Validity:
Status:
Name and address of M/s Yangtze River Pharmaceutical Group Co., Ltd.
manufacturer 1 South Yangtze River Road, Taizhou, Jiangsu,China
Name and address of marketing M/s Yangtze River Pharmaceutical Group Co., Ltd.
authorization holder 1 South Yangtze River Road, Taizhou, Jiangsu, China
Brand Name +Dosage Form + Angiovision Injection
Strength
Iohexol…. 755mg
(equivalent to 350mg of iodine)
Pharmacological Group Water-soluble, nephrotropic, low osmolar X-ray contrast media/
Non Ionic Contrast Media
Shelf life 24months (Stability studies submitted according to Zone IVA
conditions)
Pack size 100ml (Iohexol 77.5g equivalent to 350mg of iodine)
(OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL)
Me-too status Iobrix-350 Injection Of Hoffmann Human Health Pak Ltd Lahore
Detail of certificates attached Original legalized COPP:
Certificate No: F-2016-06001.
Certified by: Jiangsu Food & Drug Administration, China.
Date for Issuance: June 7, 2016.
Validity: Two Years From Issuance (it is not valid now).
Original legalized GMP Certificate:
Certificate No. CN20140268
Date for Issuance: 05/06/2014
Valid till: 05/06/2019
Remarks of the Evaluator Submit Stability study of one more batch of applied formulation both
accelerated & real time conducted in accordance with zone IV-A
conditions as you have submitted stability studies of two batches of
Submit Valid Original legalized COPP as submitted COPP is not
valid now.
Submit Original Legalised Letter of authorization as it is not
submitted.
Submit differential fee of Rs. 50,000/- as fee for registration of
imported drug product is Rs. 100, 000/-, but you have submitted Rs.
50,000/- only.
Submit Valid Copy of DSL as it is not submitted.
Explain the reason on scientific grounds that why you have not
performed sterility testing of applied formulation at any time point in
the submitted stability studies.
 For submission of Stability study data of one more batch of applied formulation both
accelerated & real time conducted in accordance with zone IV-A conditions as stability
studies data of only two batches of applied formulation is submitted.
 For submission of Original Legalized COPP for applied drug product as it is not valid now
& Original Legalised Letter of authorization as well.
 For submission of differential fee of Rs. 50,000/- as fee for registration of imported drug
product is Rs. 100, 000/-, but submitted fee is Rs. 50,000/- only.
 For Submission of Valid Copy of DSL as it is not submitted.
 Justification/ clarification on scientific grounds for not carrying out sterility testing of
applied formulation at any time point in the submitted stability studies.
927. Name and address of Applicant M/s Network Marketing Services,
14C (Commercial) P.C.H.S., Defence Road, Lahore.
Detail of Drug Sale License Address:
Validity:
Status:
Name and address of M/s Yangtze River Pharmaceutical Group Co., Ltd.
manufacturer 1 South Yangtze River Road, Taizhou, Jiangsu, China
Name and address of marketing M/s Yangtze River Pharmaceutical Group Co., Ltd.
authorization holder 1 South Yangtze River Road, Taizhou, Jiangsu, China
Brand Name +Dosage Form + Angiovision Injection
Strength
Iohexol…. 755mg
(equivalent to 350mg of iodine)
Pharmacological Group Water-soluble, nephrotropic, low osmolar X-ray contrast media/
Non Ionic Contrast Media
Shelf life 24months
Pack size 50ml (Iohexol 77.5g equivalent to 350mg of iodine)
(OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL)
Me-too status Iobrix-350 Injection Of Hoffmann Human Health Pak Ltd Lahore
Detail of certificates attached Original legalized COPP:
Certificate No: F-2016-06001.
Certified by: Jiangsu Food & Drug Administration, China.
Date for Issuance: June 7, 2016.
Validity: Two Years From Issuance (it is not valid now).
Original legalized GMP Certificate:
Certificate No. CN20140268
Date for Issuance: 05/06/2014
Valid till: 05/06/2019
Submit Valid Original legalized COPP as submitted COPP is not valid now.
Submit Original Legalised Letter of authorization as it is not submitted.
Submit differential fee of Rs. 50,000/- as fee for registration of imported drug product is Rs. 100, 000/-,
but you have submitted Rs. 50,000/- only.
 For submission of Original Legalized COPP for applied drug product as it is not valid now
& Original Legalised Letter of authorization as well.
 For submission of differential fee of Rs. 50,000/- as fee for registration of imported drug
product is Rs. 100, 000/-, but submitted fee is Rs. 50,000/- only.
 For Submission of Valid Copy of DSL as it is not submitted.
a. New Cases (Veterinary)

928. Name and address of Applicant M/s. Huzaifa International, Commercial Area, Aziz Bhatti Town,
Sargodha.
Detail of Drug Sale License Address: Commercial Area, Aziz Bhatti Town, District Sargodha
Status: Licence to sell as a ―Distributer‖
Name and address of manufacturer Shandong Soocom Animal Remedy co., Ltd. Xundakang Road No.
666 of Agricultural High & New Technology Development Zone of
Jinan, China.
Name and address of marketing Shandong Soocom Animal Remedy co., Ltd. Xundakang Road No.
authorization holder 666 of Agricultural High & New Technology Development Zone of
Jinan, China.
Name of exporting country The People‘s Republic Of China
Brand Name +Dosage Form + Enrodong -20 Oral Solution
Strength
Composition Each litre contains:
Enrofloxacin…. 200g
Target Species --------
Shelf life 24months
Pack size 1 litre
Me-too status Enroquin Forte Injection of Mehran Int Karachi
Detail of certificates attached LEGALIZED CERTIFICATE OF FREE SALES:
Certificate No. No Number
Certified by: Shandong Animal Husbandry & Veterinary Bureau.
GMP:
Legalized copy of Letter of authorization
Huzaifa International & Shandong Soocom Animal remedy Co.,
Ltd. For following products:
Oxytetracycline Injection 20 % (Oxydong-20)
Enrofloxacin Oral Solution 20% (Enrodong-20)
Validity:
Sr. Remarks of the Evaluator. Reply of the Firm.
No.
1 In case of finished product label, the Urdu Applicant has submitted Urdu version of
version of Name of drug, dosage & instructions Name of drug, dosage & instructions.
as per requirement of (Drugs labeling and
prescribing rules) 1986 is required while you
have not submitted the Urdu version of dosage.
2 Submit evidence of Shandong Animal -------
Husbandry & Veterinary Bureau as a concerned
regulatory body of M/s. Shandong Soocom
Animal Remedy.
3 Submit stability studies both accelerated & real Stability of three batches of applied drug
time of three batches of applied drug product product both accelerated & real time
conducted in accordance with zone IV-A conducted in accordance with zone IV-A
conditions. condition for 24 months is submitted by
the firm. (Data is same to that of 25°C
±2°C, RH 65%±5%)
4 In Assay of applied drug product it is mentioned Firm has replied as follow:
that number of theoretical plates should be less Chinese Veterinary Pharmaceutical
than 2500, submit reference of this limit. Pharmacopoeia 2010 Version.
Enrofloxacin test method:
Enrofloxacin solution test method:
Appendix page 36, HPLC test operate
mehod.
5 Submit copy of valid DSL of the applicant. Copy of DSL submitted by the firm
having following information on it.
Address: Commercial Area, Aziz Bhatti
Town, District Sargodha
Decision: Deferred for submission of complete original record of stability studies data both
accelerated & real time for three batches supported by attested respective documents like
chromatograms, laboratory reports, and raw data data sheets confirming conduction of stability
studies of applied formulation as per Zone IVA conditions.
929. Name and address of Applicant Huzaifa International, Commercial Area, Aziz Bhatti Town,
Sargodha.
Detail of Drug Sale License Address: Commercial Area, Aziz Bhatti Town, District Sargodha.
Jinan, China
Jinan, China
Brand Name +Dosage Form + Oxydong -5 Injection
Strength
Oxytetracycline…. 5g

Shelf life 24months
Pack size 100ml
Me-too status OXYTETRACYCLINE INJECTION of BAYER PHARMA
KARACHI
Free sale in exporting country: Confirms the free sale of the product
in exporting country.
GMP:
Validity:
Sr.# Remarks of the Evaluator. Reply of the Firm.
1 In case of finished product label, the Urdu version of Applicant has submitted Urdu version of
Name of drug, dosage & instructions as per Name of drug, dosage & instructions.
requirement of (Drugs labeling and prescribing
rules) 1986 is required while you have not submitted
the Urdu version of dosage.
2 Submit evidence of Shandong Animal Husbandry & -------
Veterinary Bureau as a concerned regulatory body of
M/s. Shandong Soocom Animal Remedy.
3 Submit stability studies both accelerated & real time Stability of three batches of applied drug
of three batches of applied drug product conducted product both accelerated & real time
in accordance with zone IV-A conditions. conducted in accordance with zone IV-A
condition for 24 months is submitted by
the firm. (Data is same to that of 25°C
±2°C, RH 65%±5%)
4 Justification/Clarification on scientific basis for not According to international
carrying out endotoxin test of applied formulation. pharmacopoeia endotoxin test is only
required to be performed for intravenous
injections or powders for injections. Our
applied drug product is oil based
injection which is injection
intramuscularly or subcutaneously,
therefore endotoxin test does not require
to be performed.
*However applied drug product is water
based injection as per data submitted in
dossier.
6 Mention the type of primary packaging material Type I glass Container.
weather it is type I, Type II, Or Type III glass
container.
Decision: Deferred for submission of complete original record of stability studies data both
accelerated & real time for three batches supported by attested respective do cuments like
studies of applied formulation as per zone IVa conditions.
930. Name and address of Applicant Huzaifa International, Commercial Area, Aziz Bhatti Town,
Sargodha.
Detail of Drug Sale License Address: Commercial Area, Aziz Bhatti Town, District Sargodha.
Jinan, China
Jinan, China
Brand Name +Dosage Form + Oxydong LA -20 Injection
Strength
Oxytetracycline…. 20g
Shelf life 24months
Pack size 100ml
Me-too status Eloxy 20% L.A Injection of Eros Pharmaceutical (Pvt) Ltd.,
Karachi.
Free sale in exporting country: Confirms the free sale of the product
in exporting country.
GMP:
Validity:
Sr.# Remarks of the Evaluator. Reply of the Firm.
1 In case of finished product label, the Urdu Applicant has submitted Urdu version of
version of Name of drug, dosage & instructions Name of drug, dosage & instructions.
as per requirement of (Drugs labeling and
prescribing rules) 1986 is required while you
have not submitted the Urdu version of dosage.
2 Submit evidence of Shandong Animal Husbandry -------
& Veterinary Bureau as a concerned regulatory
body of M/s. Shandong Soocom Animal Remedy.
3 Submit stability studies both accelerated & real Stability of three batches of applied drug
time of three batches of applied drug product product both accelerated & real time
conducted in accordance with zone IV-A conducted in accordance with zone IV-A
conditions. condition for 24 months is submitted by the
firm. (Data is same to that of 25°C ±2°C, RH
65%±5%)
4 Justification/Clarification on scientific basis for According to international pharmacopoeia

not carrying out endotoxin test of applied endotoxin test is only required to be
formulation. performed for intravenous injections or
powders for injections. Our applied drug
product is oil based injection which is
injection intramuscularly or subcutaneously,
therefore endotoxin test does not require to
be performed.
*However applied drug product is water
based injection as per data submitted in
dossier.
6 Mention the type of primary packaging material Type I glass Container.
weather it is type I, Type II, Or Type III glass
container.
7 Submit copy of valid DSL of the applicant. Copy of DSL submitted by the firm having
following information on it.
Address: Commercial Area, Aziz Bhatti
Town, District Sargodha
Decision: Deferred for submission of complete original reco rd of stability studies data both
accelerated & real time for three batches supported by attested respective documents like
studies of applied formulation as per zone IVa conditions.
931. Name and address of Applicant M/s. Ghazi Brothers, Ghazi House, D-35, K.D.A Scheme No. 1,
Miran Muhammad Shah Road, Karachi-75350, Pakistan.
Detail of Drug Sale License Address: M/s. Ghazi Brothers, Gazi house D-35, KDA Scheme
No.1. Miran Muhammad Shah Road, Karachi.
Validity: 25 May, 2020
Status: License to sell drugs as a Distributor
Name and address of manufacturer Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
Industrial Park, Pucheng, Fujian, China.
Name and address of marketing Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
authorization holder Industrial Park, Pucheng, Fujian, China.
Brand Name +Dosage Form + Sinomd Powder (for oral use)
Strength
Composition Each 1kg of powder contains:
Bacitracin (as methylene disalicylate)… 500g
(700g of bacitracin methylene disalicylate eq. to 500g of bacitracin
base)
Shelf life 3 years
(Conditions: Accelerated 40±2, 75%±5% for 6 months
Real time: 25±2, 60%±5% )
Pack size 100gm, 250gm, 500gm, 1kg, 5kg , 10kg , 25kg
Me-too status Not verified

Detail of certificates attached Original Legalized Free Sale Certificate:
 Issued by: Pucheng Administration of Animal Husbandry
& Veterinary & Aquatic Products.
 Issued on: 14/January/2016
 Free sale in exporting country: confirms the free sale of
the product in exporting country.
Original Legalized GMP Certificate:
 Certificate No.: (2015) S.Y.GMP Z.Zi, No.13003
 Issued by: Ministry of Agriculture of the People Republic
of China, Fujian Province.
 Issued on:21/August/2015
 Valid till:20/August/2020
Original legalized letter of authorization:
 Lifecome biochemistry Vs. Ghazi Brothers for following
formulations:
Sinobac 15% granular(Bacitracin 15% granular)
Sinomd 15% granular (Bacitracin methylene disalicylate)
Sinocol 10% granular(Colistin Sulpahte 10% granular)
Sinomd water soluble (Bacitracin methylene disalicylate
50% soluble powder)
Remarks of the Evaluator.  Stability data is in accordance with zone IV-a Conditions.
932. Name and address of Applicant M/s. Ghazi Brothers, Ghazi House, D-35, K.D.A Scheme No. 1,
Miran Muhammad Shah Road, Karachi-75350, Pakistan.
Detail of Drug Sale License Address: M/s. Ghazi Brothers, Gazi house
d-35, KDA Scheme No.1. Miran Muhammad Shah Road, Karachi.
Validity: 25 May, 2020
Status: License to sell drugs as a Distributor
Name and address of manufacturer Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
Industrial Park, Pucheng, Fujian, China.
Name and address of marketing Life Come Biochemistry Co., Ltd. No. 19 Nanpu Ecological
authorization holder Industrial Park, Pucheng, Fujian, China.
Brand Name +Dosage Form + Sinocol Powder 10% (for oral use)
Strength
Composition Colistin as sulphate 10% granular
Colistin sulphate….. 125g (as Colistin 100g)
Shelf life 2 years
(Conditions: Accelerated 40±2, 75%±5% for 6 months
Real time: 25±2, 60%±5% )
Pack size 1kg, 5kg , 10kg , 25kg
Me-too status Not verified
Detail of certificates attached Original Legalized Free Sale Certificate:
 Issued by: Pucheng Administration of Animal Husbandry
& Veterinary & Aquatic Products.
 Issued on: 14/January/2016
 Free sale in exporting country: confirms the free sale of
the product in exporting country.
Copy of Legalized GMP Certificate:
 Certificate No.: (2015) S.Y.GMP Z.Zi, No.13003
 Issued by: Ministry of Agriculture of the People Republic
of China, Fujian Province.
 Issued on:21/August/2015
 Valid till:20/August/2020
Copy of legalized letter of authorization:
 Lifecome biochemistry Vs. Ghazi Brothers for following
formulations:
Sinobac 15% granular(Bacitracin 15% granular)
Sinomd 15% granular (Bacitracin methylene disalicylate)
Sinocol 10% granular(Colistin Sulpahte 10% granular)
Sinomd water soluble (Bacitracin methylene disalicylate
50% soluble powder)
Remarks of the Evaluator.  Stability data is in accordance with zone IV-Conditions.
c. Deferred Cases:
i. Human
933. Name and address of Applicant M/s Helix Pharma (Pvt) Ltd. Hakimsons House, A/56, S.I.T.E
Manghopir Road Karachi.
Detail of Drug Sale License Address:Helix pharma (pvt) Ltd., Hakim sons house A-56,
S.I.T.E. Karachi.
Validity:
Name and address of manufacturer Reliance Life sciences Pvt Ltd., Plant 3,5,6, Dhirubhai life
Sciences centre (DALC) r-282 Thane- Belapur Road, Rabale,
Navi Mumbai- 400701, India.
Name and address of marketing Reliance Life sciences Pvt Ltd., Plant 3,5,6, Dhirubhai life
authorization holder Sciences centre (DALC) r-282 Thane- Belapur Road, Rabale,
Type of Form Form 5A
Brand Name+Dosage Form+ Erlotirel 100 Tablets
Strength
Erlotinib……. 100mg
Pharmacological Group Anti-Cancer
Demanded Price As Per MRP
Pack size
Me-too status Tarceva 100mg tablets of Roche Pakistan Limited, Karachi
Detail of certificates attached Original legalized CoPP:
Certificate No: COPP/CERT/KD/60727/2017/11/20552/103919
Certified by: Food & Drug administration, M.S. Bandra-Kurla
Complex Bandra –Kurla Complex, Mumbai, Maharashtra State,
India
Issued on: 23/08/2017
Valid up to: 17th May 2019

GMP:The facilities and operations conform to GMP as
Original legalized Free sale Certificate:
(This certificate is issued for export registration)
Certified by: Food & Drugs Administration Konkan Division,
Maharashtra State, India.
Validity: Untill 23/10/2018
Remarks of the Evaluator.  Reliance Life sciences has submitted two Original legalized
Free sale Certificate as mentioned below:
One certificate is issued for export registration only.(In-House)
Second certificate is issued for product freely sold in India(IP)
 Submit complete stability study data both accelerated & real
time of three batches of applied formulation as per zone IVa
conditions as you have submitted only six month accelerated
data for three batches & 3 months real time data for one
batch and 6 month real time for two batches as per zone IVb
conditions.
Previous decision Registration Board in its 288th meeting deferred the case for the
following:
For submission of stability data at real time of three batches of
applied formulation as per Zone IVa till claimed shelf life.
Evaluation by PEC Applicant has submitted stability studies.
Decision: Approved with innovator‘s specification & as per Policy for inspection of Manufacturer
abroad.
934. Name and address of Applicant M/s Helix Pharma (Pvt)Ltd. Hakimsons House, A/56, S.I.T.E
Manghopir Road Karachi.
Detail of Drug Sale License Address:Helix pharma (pvt) Ltd., Hakim sons house A-56,
S.I.T.E. Karachi.
Validity:
Name and address of manufacturer Reliance Life sciences Pvt Ltd., Plant 3,5,6, Dhirubhai life
Sciences centre (DALC) r-282 Thane- Belapur Road, Rabale,
Name and address of marketing Reliance Life sciences Pvt Ltd., Plant 3,5,6, Dhirubhai life
authorization holder Sciences centre (DALC) r-282 Thane- Belapur Road, Rabale,
Brand Name +Dosage Form + Erlotirel 150 Tablets
Strength
Erlotinib……. 150mg
Pharmacological Group Anti-Cancer
Demanded Price As Per MRP
Pack size 3×10‘s tablets
Me-too status Tarceva 150mg tablets of Roche Pakistan Limited, Karachi
Detail of certificates attached Original legalized CoPP:
Certificate No: COPP/CERT/KD/60572/2017/11/20441/103630
Certified by: Food & Drug administration, M.S. Bandra-Kurla
Complex Bandra –Kurla Complex, Mumbai, Maharashtra State,
India
Issued on: 11/08/2017
Valid up to: 17th May 2019
GMP:The facilities and operations conform to GMP as
Original legalized Free sale Certificate:
(This certificate is issued for export registration)
Certified by: Food & Drugs Administration Konkan Division,
Maharashtra State, India.
Validity: Untill 23/10/2018
Remarks of the Evaluator.  Reliance Life sciences has submitted two Original
legalized Free sale Certificate described below:
One certificate is issued for export registration only.(In-House)
Second certificate is issued for product freely sold in India(IP)
 Data of 03 batches supported by attested respective
documents like chromatograms, laboratory reports, data
sheets etc.
Previous decision Registration Board in its 288th meeting deferred the case for the
following:
For submission of stability data at real time of three batches of
applied formulation as per Zone IVa till claimed shelf life.
Evaluation by PEC Applicant has submitted stability studies.
Decision: Approved with innovator‘s specification & as per Policy for inspection of Manufacturer
abroad.
ii. Veterinary.
935. Name and address of Applicant M/s Vet line international Flat # 55/5, first floor, main shadman
market, Lahore.
Detail of Drug Sale License Address: Vet line international Flat # 55/5, first floor, main
shadman market, Lahore.
Name and address of manufacturer M/s Range Pharma Sdn. Bhd. No.1, Jalan TSB 11, Taman Industri
Sungai Buloh, 47000 Sungai Buloh, Selangor Darul Ehsan,
Malaysia.
Name and address of marketing M/s Range Pharma Sdn. Bhd. No.1, Jalan TSB 11, Taman Industri
authorization holder Sungai Buloh, 47000 Sungai Buloh, Selangor Darul Ehsan,
Malaysia.
Name of exporting country Malaysia
Brand Name +Dosage Form + Quinosol 20% Solution (oral)
Strength (Water Soluble Liquid: Enrofloxacin; 200mg/ml)
Composition Each 1ml of liquid contains:
Enrofloxacin ……. 200mg
Target Species Broilers, Turkeys, Pullets
Pack size 200ml, 500ml, 1liter
International availability
Me-too status Enroxsel 20 Oral Solution Of Selmore Pharmaceuticals
Detail of certificates attached Original legalized CoPP
Certificate No. 0473H/2017
Certified by: Drug Control Authority, National Pharmaceutical
Regulatory Division (NPRA), Ministry Of Health Malaysia.
Letter of authorization
Vet line international & Range Pharma
Validity: 3years from date of signature i.e. 15th-05-2017.
Remarks of the Evaluator.  Quantity of excipients mentioned in product formula attached
alongside the COPP is different from that mentioned in SmPC
& under Heading of composition on Form 5A. Clarify/Justify.
 Justification on scientific basis for addition of 2 % overage of
enrofloxacin in master formulation.
 Long term stability data of API is for Neomycin Sulphate
instead of Enrofloxacin.
 In Finished Product Specifications under microbial
contamination test, limits of microbial count are not
mentioned. Mention the limits of microbial count.
Previous Decision Registration Board in its 287th meeting deferred the case for
the following:
 Quantity of excipients mentioned in product formula attached
alongside the COPP is different from that mentioned in SmPC
& under Heading of composition on Form 5A. Clarify/Justify.
 Justification on scientific basis for addition of 2 % overage of
enrofloxacin in master formulation.
 Long term stability data of API is for Neomycin Sulphate
instead of Enrofloxacin.
Evaluation by PEC:
Sr. Registration Board in its 287thmeeting Response of the firm
No. deferred the case for the following
reason:
1  Quantity of excipients mentioned in The firm has submitted a clarification letter from
product formula attached alongside M/s. Range Pharmaceuticals addressed to DRAP
the COPP is different from that wherein it is stated that in the COPP, the amount of
mentioned in SmPC & under active ingredient, enrofloxacin, is expressed per ml
Heading of composition on Form 5A. (200mg/ml) whilst the excipients are expressed per
Clarify/Justify. litre (L). Whereas both the active ingredient &
excipients mentioned in the SmPC & composition
provided under form 5A were expressed per ml.
The COPP unit description is due to the way the
product content is recorded in our Registration
filling with our Regulatory Body. However, we
confirm that the attached COPP, SmPc, &
Composition provided under heading of

composition on form 5A are equivalent, which are
as follow:
Each ml of Quinosol 20% solution contains:
Active substance:
Enrofloxacin… 200mg
Excipients:
Potassium hydroxide… 32mg
Propylene glycol…200mg
Sodiumthiosulfite…1.25gm
Benzyl alcohol… 0.01ml
Purified water… 0.05ml
2 Justification on scientific basis for The additional 2% overage of enrofloxacin in
addition of 2 % overage of enrofloxacin master formulation is added to compensate the
in master formulation. processing or handling loss during production.
3 Long term stability data of API is for Long term stability data of API (Enrofloxacin.) is
Neomycin Sulphate instead of submitted.
Enrofloxacin.
4 In Finished Product Specifications underFirm has submitted that microbial contamination
microbial contamination test, limits of test limits were established according to BP 2012
microbial count are not mentioned. (Appendix XVID, Microbiological Quality of Non-
Mention the limits of microbial count. sterile Pharmaceutical Preparations & Substance
for Pharmaceutical use.)
market, Lahore.
Name and address of manufacturer M/s Range Pharma Sdn. Bhd. No.1, Jalan TSB 11, Taman Industri
Sungai Buloh, 47000 Sungai Buloh, Selangor Darul Ehsan,
Malaysia.
Name and address of marketing M/s Range Pharma Sdn. Bhd. No.1, Jalan TSB 11, Taman Industri
authorization holder Sungai Buloh, 47000 Sungai Buloh, Selangor Darul Ehsan,
Malaysia.
Brand Name +Dosage Form + Mucolin 1% Powder(Oral)
Strength (Water Soluble Liquid: Bromhexine hydrochloride; 10mg/ml)
Composition Each 1ml of liquid contains:
Bromhexine hydrochloride ……. 10mg
Target Species Cattle, Poultry
Pharmacological Group Mucolytic
Pack size 200ml, 500ml, 1liter
International availability
Me-too status Broncoden of Lexicon & broncoveex of Samara
Detail of certificates attached Original legalized CoPP
Certificate No. 0479H/2017
Certified by: Drug Control Authority, National Pharmaceutical
Regulatory Division (NPRA), Ministry Of Health Malaysia.
Issued date: 25th /09/2017
Letter of authorization
Vet line international & Range Pharma
Validity: 3years from date of signature i.e. 15th-05-2017.
Remarks of the Evaluator.  Justification on scientific basis for addition of 2 %
overage of Bromhexine hydrochloride in master
formulation.
number, brand name and name of firm as the provided me
too contains some other ingredients as well.
the following:
 Justification on scientific basis for addition of 2 %
overage of Bromhexine hydrochloride in master
formulation.
number, brand name and name of firm as the provided me
too contains some other ingredients as well.
Evaluation by PEC
Sr. Registration Board in its 287th meeting deferred Response of the firm
No. the case for the following reason:
1 Justification on scientific basis for addition of 2 The additional 2% overage of
% overage of Bromhexine hydrochloride in enrofloxacin in master formulation is
master formulation. added to compensate the processing or
handling loss during production.
2 In Finished Product Specifications under Firm has submitted that microbial
microbial contamination test, limits of contamination test limits were
microbial count are not mentioned. Mention established according to BP 2012
the limits of microbial count. (Appendix XVID, Microbiological
Quality of Non-sterile Pharmaceutical
Preparations & Substance for
Pharmaceutical use.)
3 Evidence of applied formulation/drug already Evidence of Me TOO
approved by DRAP (generic / me-too status) Brand Name: Bromocin Oral Liquid
alongwith registration number, brand name and Name of manufacturer: Biogen Pharma
name of firm as the provided me too contains Registration NO: 063803
some other ingredients as well
market, Lahore.
Name and address of manufacturer M/s Bela Pharm GmbH & Co.KG LohnerStrasse 19
49377 Vechta, Germany.
Name and address of marketing M/s Bela Pharm GmbH & Co.KG LohnerStrasse 19
authorization holder 49377 Vechta, Germany.
Brand Name +Dosage Form + Neomycinsulfat (Water Soluble Powder)
Strength
Composition Each 1gm of powder contains:
Neomycin Sulphate……. 1000mg
Target Species Cattle, Chicken
Pharmacological Group Aminoglycoside antibiotic
Shelf life 2years
Pack size 500gm, 1kg
Me-too status Dufa-Neogut Water Soluble Powder Of M/S. N.B. Sons (Pvt)
Ltd.
Detail of certificates attached Copy of Original legalized CoPP
Certificate No. 41401-7/8-14/012
Certified by: Staatl. Gewerbeaufsichtsamt Oldenburg,
Theodor- Tantzen- Platz 8
D-26122 Oldenburg.
Remarks of the Evaluator.  Submit stability study data of three batches of applied drug
product both accelerated & real time according to zone IV-
A conditions, as you have submitted stability study data of
two batches of applied drug product.
 Submit Original legalized COPP as you have submitted
Copy of COPP.
Evaluation by PEC: The representative of firm has informed
that they have submitted the Original legalized COPP in year
2014, at that time their application was rejected but after six
month same formulation was approved by the Registration
Board, now we have again submitted application for this
formulation & documents are attached inside the dossier of
previous application.
Previous Decision Registration Board in its 288th Meeting deferred the case for
the following:
 Submission of original, legalized and Valid CoPP.
 Submision of Long term stability studies conducted
under the conditions of zone IV-A of remaining 1
batch till shelf life.
Evaluation by PEC
Sr. Registration Board in its 288th Response of the firm

No. Meeting deferred the case for the
following:
1 Submission of original, legalized Applicant has submitted the following:
and Valid COPP. Original legalized CoPP
Certificate No. DE-NI-04-WHO-2019-0008
Certified by: Staatl. Gewerbeaufsichtsamt Oldenburg,
Theodor- Tantzen- Platz 8
D-26122 Oldenburg.
Free sale in exporting country: Confirms the free
sale of the product in exporting country.
GMP: The facilities and operations conform to GMP
as recommended by WHO as per COPP.
2 Submission of Long term stability Applicant has submitted stability study data both
studies conducted under the accelerated & real time for one more batch of applied
conditions of zone IV-A of drug product.
remaining 1 batch till shelf life.
Case no. 07 Registration applications of drugs for which stability study data is submitted.
a. Verification of stability study data
938. Name and address of M/s Pharmatec Pakistan (Private) Limited, D-86/A, S.I.T.E.,
manufacturer / Applicant Karachi- 75700
Brand Name +Dosage Form + Apixa tablet 5mg
Strength
Composition Each film coated tablet Contains:
Apixaban …. 5mg
Diary No. Date of R& I & fee Dy. No. 21690: 21-06-18, 20,000(23-12-14)+30,000(17-05-16)
duplicate fee challan
Pharmacological Group Antithrombotic Agents
dosage form)
GMP status --------
Drug Apixa tablet 5mg
Name of Manufacturer M/s Pharmatec Pakistan (Private) Limited, D-86/A, S.I.T.E., Karachi- 75700
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., LTD.
Previously (M/s. Jiangxi Tonghe Pharmaceutical Co., Ltd.)
API Lot No. 20170204V
Description of Pack
14‘s: Alu/PVC blister
Time Period Accelerated: 3 Month Real Time: 3 Month
Frequency Accelerated: 0,3,6 (Month) Real Time: 0,3,6 (Month)
Batch No. 17PD067APIT01(A) 17PD067APIT01(B) 17PD083APIT02(A)

Manufacturing Date October 2017 October 2017 November 2017
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of M/s Jiangxi Synergy Pharmaceutical Co., LTD. This
country of origin or GMP certificate of API was Previously named as M/s. Jiangxi Tonghe
manufacturer issued by regulatory authority of Pharmaceutical Co., Ltd. (As per API manufacture‘s
country of origin. Web information).
Certificate number : JX20150013
etc.
ADC attested commercial invoice of August, 2017
stating 0.2 kg of apixaban is submitted by the firm
Rules, 1978.
939. Name and address of manufacturer / M/s Pharmatec Pakistan (Private) Limited, D-86/A,
Applicant S.I.T.E., Karachi- 75700
Brand Name + Dosage Form + Strength Apixa tablet 2.5mg
Apixaban …. 2.5mg
Diary No. Date of R& I & fee Dy. No. 21690: 21-06-18, 20,000(23-12-14)+30,000(17-
05-16) duplicate fee challan
Pharmacological Group Antithrombotic Agents
Me-too status (with strength and dosage N/A
form)
GMP status --------
Drug Apixa tablet 2.5mg
Name of Manufacturer M/s Pharmatec Pakistan (Private) Limited, D-86/A, S.I.T.E., Karachi- 75700
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., LTD.
Previously (M/s. Jiangxi Tonghe Pharmaceutical Co., Ltd.)
API Lot No. 20170204V
Description of Pack
10‘s: Alu/PVC blister
Time Period Accelerated: 3 Month
Real Time: 3 Month
(Now they have submitted six month data of both real time and accelerated)
Frequency Accelerated: 0,3,6 (Month)
Batch No. 17PD066APIT01(A) 17PD066APIT01(A) 17PD092APIT04(A)
Manufacturing Date October 2017 October 2017 November 2017
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of M/s Jiangxi Synergy Pharmaceutical Co., LTD. This
country of origin or GMP certificate of API was Previously named as M/s. Jiangxi Tonghe
manufacturer issued by regulatory authority of Pharmaceutical Co., Ltd. (As per API manufacture‘s
country of origin. Web information).
Certificate number : JX20150013
etc.
ADC attested commercial invoice of August, 2017
stating 0.2 kg of Apixaban is submitted by the firm
Rules, 1978.
Inspection Report
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Apixa 2.5mg &
5mg (Apixaban) Tablets by M/s. Pharmatec Pakistan (Private) Ltd., S.I.T.E, Karachi.
Investigation Date and Time: 30th April, 2019 (Morning).

Investigation Site: Factory premises of M/S. Pharmatec Pakistan (Private) Ltd., D-86/A, S.I.T.E, Karachi.
Background:
Chairman Registration Board considered the applications of M/S. Pharmatec Pakistan (Private) Ltd., D-86/A,
S.I.T.E, Karachi for registration of Apixa 2.5mg & 5mg (Apixaban) Tablets and constituted a three-member
panel to investigate the authenticity / genuineness of data (import of raw material and stability data). Panel was
advised to conduct inspection of the firm and to submit report for further consideration.
1. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women, Karachi. (Member
Registration Board) Islamabad.
3. Mr. Abdul Waheed, Assistant Director, CDL, DRAP, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing
of stability batches and stability studies on these batches.

ongoing studies, printed data and integrity and security of data in respective databases were also audited. The
details of investigation may be summarized as under:
APIXA 2.5MG AND 5MG TABLETS
Sr.# Question Observation bypanel
1. Doyouhavedocumentsconfirmingthe import of Thefirmhasimported 0.2 kg Apixaban API (Lot No.

Apixaban API including approvalfromDRAP? 20170204V) fromM/S. Jiangxi Synergy
Pharmaceutical Co., Ltd., China. Approval fromDRAP
Office,Karachi was obtained on August, 2017.
2. Whatwastherationalebehind selecting the There is proper vendor evaluation process being
particularmanufacturer ofAPI? implementedincluding auditchecklist,Testingof the
APIand GMP approvalbycompetentauthority along with
the DMF.
3. Doyouhavedocumentsconfirmingthe importof The firm has document confirming the import of
Apixaban reference standard and Apixaban (API), working standardoftheAPIand 8 major
impuritystandard? impuritiesfromthe manufacturerofthe API.
4. Do you have certificate of Analysis of the ThefirmhascertificateofanalysisfortheAPI,working
API,referencestandardoftheAPIand standardofthe API and 8 impurities standards.
impuritystandard?
5. Do youhaveGMPcertificateofAPI The firm has valid GMP certificate of the API
authoritiesofcountryoforigin? Regulatory Authority of thecountryoforigin.
6. DoyouuseAPImanufacturermethodof Thefirmhasused API manufacturer methodfor testing
testingfortestingAPI? API.
7. Doyouhavestabilitystudiesreporton API? The firmhasstabilitystudies reports on the API.
8. Ifyes,whetherthestabilitytestinghas The stabilitytestinghasbeen performed as per SIM
beenperformedasperSIM methodand method and major degradationproducts (02) have been
degradation products have been quantified? quantified.
9. Doyouhavemethodforquantifyingthe The firmhasmethodforquantifying the impurities in the
impuritiesinthe API? API.
10. Doyouhavesomeremainingquantitiesof the ThefirmhasremainingquantitiesoftheAPI, working
API, its reference standard and standard of API and 08 impurity standards.
impuritiesstandards?
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? including Avicell PH 102, Povidone, Talc, Magnesium
Stearate, Opadry.
12. Doyouhavedocumentsconfirmingthe The firm has documents confirming the import of all
importoftheusedexcipients? excipients used.
13. Doyouhavetestreportsandotherrecords on The firmhastest reports and other records on the

theexcipients used? excipient used.
14. Do you have written and authorized protocols The firmhas written and authorized protocols for the
for thedevelopmentof Apixa Tablets? developmentof Apixa 2.5mg and 5mg Tablets.
15. Have you performed Drug-excipient Drug excipients compatibility testing has not been
compatibilitystudies? performed as formulations are same as that of innovator
tablets.
16. Have you performed comparative dissolution The firm has performed comparative dissolution studies
studies? of 2.5mg and 5mg Apixa tablets against innovator
tablets (Eliquis 2.5mg and 5mg tablets manufactured by
BMS, USA) and their tablets have shown comparable
dissolution profiles to that of the innovator tablets.
17. Doyouhaveproductdevelopmentsection? The firm has product development section with
equipment for manufacturing of tablet dosage form.
The analytical part has been performed in routine QC
Lab. The R&D section needs improvements in terms of
segregation of operations and HVAC system.
18. Do you have necessary equipment As above.
availableinproduct developmentsection
fordevelopmentof Apixa Tablets?
19. Arethe equipment in product The available equipment in product development
developmentsection qualified? section are qualified.
20. Do you have proper maintenance calibration / The firm has proper maintenance/ calibration withre-
re-qualificationprogramfor the qualificationprogramfor the equipment used for product
equipmentusedin PD section? development.
21. Do you have qualified staff in product The firm has a team of 04 technicalpersons (03
development section with proper knowledge Pharmacist & 1 Chemist) for product development.
and training in product development? These personnel have proper knowledge and training in
22. Have you manufactured three stability batches The firm has manufactured three stability batches of:
for the stability studies of Apixa tablets 1. Apixa Tablets 2.5mg havingbatch #
asrequired? 17PD066APIT01(A), 17PD066APIT01(A) and
17PD092APIT04 (A) eachof5000 tablets batchsize.
2. Apixa Tablets 5mg havingbatch #
17PD067APIT01(A), 17PD067APIT01(B) and
17PD083APIT02 (A) eachof5000 tablets batchsize.
The tablets are packed in Alu/PVC blisters ofpacksize
14‘s and 10‘s for 5mg & 2.5mg strengths respectively.
23. Doyouhaveanycriteriaforfixingthe batchsize The criteria for fixing the batch size of stability batches
ofstabilitybatches? is the equipment size (Maximum 5kg) of tablets and the
number of tablets required for whole stability testing.
24. Do you have complete record of The firm hascompleterecordofproductionofstability
production ofstabilitybatches? batches. Allthe LogBooks are properly maintained.
26. Do you have developed and validated the The firm has used the API related substance method for
method for testing of stability batches? testing of their stability batches. The stability indicating
nature of the method has been supported by forced
degradation studies. Spiking studies also have been
performed recently. The method is also completely
validated.
27. Doyouhavemethodtransferstudiesin The firm has performed complete validation studies.
casewhenthemethodoftestingbeing
usedbyyourfirmisgivenbyanyother lab?
28. Doyouhavedocumentsconfirmingthe The firm has proper documents confirming the
qualificationofequipments/instruments being qualificationofequipment/instrumentsbeingusedinthe
used in the test and analysis of Apixaban testandanalysis ofthe APIand the finished drug.
APIand the finished drug?
29. Do your method of analysis stability The firm‘s method of analysis is stability indicating.
indicating?
30. Do your HPLC software 21CFR Compliant? The HPLC software is 21CFR Compliant as per record
available with the firm and as evidenced by the
practices.
31. Can you show Audit trail reports on Apixaban Audittrailonthetestingreports is available.
testing?
32. Do you have some remaining quantitiesof Thefirmhasremainingquantitiesof two degradation
degradation products and stability batches? products (major degradation products) and stability
batches.
33. Do you have stability batches kept on The firm has completed accelerated stability testing on
stabilitytesting? the three stability batches of both strengths. The real
time stability testing is in progress on all the three
stability batches. Degradation products quantification
has been made on 12 months studies, however, testing
has been performed throughout as per SIM method.
34. Doyouhavevalidcalibrationstatus for the Thefirmhasvalidcalibrationstatusfortheequipmentused
equipment‘s used in Apixa Tablets production in Apixa 2.5mg and 5mg Tablets production and
andanalysis? analysis.
35. Do proper and continuous monitoring and Continuous power supply and monitoring are available
control are available for stability chamber? for stability chambers.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel
personnel and utilities berated as GMP and utilities are rated as GMP compliant.
compliant?
Conclusions:
firm for registration of Apixa 2.5mg and 5mg (Apixaban) Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suited for the
manufacturing of Apixa 2.5mg and 5mg (Apixaban) Tablets.
Recommendations:
1. Apixa 2.5mg and 5mg (Apixaban) Tablets are recommended for registration in the name of the firm.
2. The API falls in BCS Class III (Highly soluble and Poorly permeable) and has problematic
bioavailability and the reference product (EMA Assessment Report on Eliquis Tablet) has shown
significant variation (20%-30%) within participants, therefore, the panel recommends post-registration
bioequivalence studies and post-marketing safety studies on Apixa tablets also.
Decision: Registration Board decided to approve registration of ―Apixa 2.5mg and 5mg (Apixaban)
Tablets by M/S. Pharmatec Pakistan (Private) Ltd. Manufacturer will place first three production batches
of the product on long term stability studies throughout proposed shelf life and on accelerated studies for
six months.
940. Name and address of manufacturer / M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi Industrial
Applicant Area, Karachi.
Brand Name +Dosage Form + Strength EstineTablets 10mg
Composition Each Oro-dispersible tablet contains:
Ebastine…10mg
Diary No. Date of R& I & fee Dy.No. 4910; 06-06-17: Rs. 20,000 & Rs. 30,000
Type of Form Form 5D
Pack size & Demanded Price 10‘s: Rs. 250.00/-
dosage form)
GMP status Based on the area inspected, the people met and the
documents reviewed, the considering the findings of the
inspection, including the observations listed in the inspection
report, M/s Getz Pharma, Karachi was considered to be
operating at an acceptable level of compliance with GMP
guidelines as of today.
Drug EstineTablets 10mg (Ebastine10mg)
Name of Manufacturer M/s Getz Pharma (Pvt.) Ltd. 29-30/27, Korangi Industrial Area, Karachi.
Manufacturer of API Bal Pharma Limited, India
API Lot No. API Batch # 500111706023
Description of Pack
Alu-Alu blister
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,3,6 Months
Batch No. 418DS01 418DS02 418DS03
Batch Size 25000 tablets
25000 tablets 25000 tablets
Manufacturing Date January, 2018 January, 2018 January, 2018

Date of Initiation March, 2018 March, 2018 March, 2018
No. of Batches 03
Date of Submission Dy. No.38888, 27-11-18
No.
1. COA of API COA of Ebastine from Bal Pharma Limited, India, is
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate:
country of origin or GMP certificate of API Certificate No. DCD/CR-2096 GSC NO.
manufacturer issued by regulatory authority of 13561/SPL.CL-I/2017-2018.
country of origin. Issued By: Drugs Control Department, Government of
Karnataka.
Validity: One year from date of Issue i.e. 05th April
2018.
etc.
th
data / documents.
Rules, 1978.
Inspection Report
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Estine
(Ebastine) 10mg & 20mg Oro-dispersible Tablets by M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Industrial Area , Karachi.
Reference No: F.13-11/2017-PEC (Vol.I) dated 25th April, 2019.

Investigation Date and Time: 6th May, 2019. (Forenoon)
Investigation Site: Factory premises of M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Background:
Chairman Registration Board considered the applications of M/s Getz Pharma Pvt. Limited, 29-30/27,
Korangi Industrial Area, Karachi for registration of Estine (Ebastine) 10mg & 20mg Oro-dispersible Tablets and
constituted a three member panel to investigate the authenticity / genuineness of data (import of raw material and
stability data). Panel was advised to conduct inspection of the firm and to submit report for further consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Dean Faculty of Pharmacy, Ziauddin University.
(Member Registration Board)
2. Dr. Kirshan Das, Assistant Director, DRAP, Karachi

Estine (Ebastine) Tablets 10mg & 20mg, Oro-dispersible Tablets
Q. Question Observation by panel
No.
1 Do you have documents confirming the The firm has imported ―Ebastine API‖ from M/s Bal
import of Ebastine API including approval Pharma Ltd, India and has approval from DRAP for
from DRAP? import vide License No.1657/17-DRAP (K) dated
21.06.2017.
2 What was the rationale behind selecting the There is proper vendor evaluation process being
particular manufacturer of API? implemented by the firm and the rationale behind vendor
selection is controlled through Postal Audit checklist /
Physical Site Inspection and availability of valid GMP
approval by competent authority. Further, M/s Bal
Pharma Ltd, India has Certificate of Suitability (CEP) for
Ebastine API issued by European Directorate for the
Quality of Medicines & HealthCare (EDQM).
3 Do you have documents confirming the Firm has imported Ebastine working standard from M/s
import of Ebastine reference standard and Bal Pharma Ltd, India vide invoice No. SAM-010 dated

impurity standards? 14.06.2017.
For impurity testing, firm has used Relative Retention
Time (RRT) for location and calculation of impurities as
provided by Ph. Eur.
4 Do you have certificate of Analysis of the The firm has certificate of analysis for API and working
API, reference standards and impurity standard.
standards?
5 Do you have GMP certificate of API Firm has provided copy of valid GMP certificate of M/s
manufacturer issued by regulatory authority Bal Pharma Ltd, India valid till 04-02-2020.
6 Do you use API manufacturer method of The firm has used method of testing adopted from
testing for testing API? European Pharmacopeia (Ph. Eur) monograph for
Ebastine API and the same has been verified as per USP
chapter 1226 (verification of compendial procedure)
7 Do you have stability studies reports on The firm has 5 years real time stability study data
API? provided by API manufacturer.
performed as per SIM method and method and degradation products have been quantified.
9 Do you have method for quantifying the Yes, the firm has method for quantifying the impurities in
impurities in the API? the API adopted from European Pharmacopeia (Ph. Eur)
monograph for Ebastine API.
10 Do you have some remaining quantities of The firm has some remaining quantities of the API and
the API, its reference standard and working standard.
11 Have you used pharmaceutical grade The firm have used pharmaceutical grade excipients
excipients? which include Microcrystalline Cellulose (Avicel PH-
101), Mannitol, Poloxamer 188, Povidone K-30,
Hypromellose, Carboxymethylcellulose Calcium,
Colloidal Anhydrous Silica, Croscarmellose Sodium,
Crospovidone, Aspartame, Trusil Powder Orange
Flavour and Magnesium Stearate.
12 Do you have documents confirming the The firm has necessary documents confirming the import
13 Do you have test reports and other records The firm has test reports and other records on the
on the excipients used? excipients used.
14 Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of Ebastine development of Ebastine Oro-dispersible Tablets 10mg &
tablets? 20mg.
15 Have you performed Drug-excipient The firm has performed Drug-excipient compatibility
compatibility studies? studies and concluded that the excipients used in the
proposed formulation of Ebastine Oro-dispersible Tablets
10mg & 20mg are compatible with the API.
16 Have you performed comparative The firm has used dissolution criteria as per Japanese
dissolution studies? Pharmacopoeia monograph for Ebastine Oro-dispersible
Tablets and the product complies. Further, this product is
orally dispersible which disintegrates very rapidly. The
release is more than 85% within 15 minutes, therefore,
F2 waiver is applicable.
17 Do you have product development (R&D) The firm has dedicated product development (R&D)
section section with requisite manufacturing and analysis
facilities.
18 Do you have necessary equipment available The firm has necessary equipment available in product
in product development section for development section for development ofEbastine Oro-
development of Ebastine tablets? dispersible Tablets 10mg & 20mg.
19 Are the equipment in product development The available equipment in product development section
section qualified? are qualified.
20 Do you have proper maintenance / The firm has proper maintenance / calibration with re-
21 Do you have qualified staff in product The firm has qualified staff in product development
development section with proper knowledge section with proper knowledge and training in product
and training in product development? development. There are 50 Scientists (Pharmacist &
Chemist) working only in R&D Section.
22 Have you manufactured three stability The firm has manufactured three stability batches of
batches for the stability studies of Ebastine Ebastine Oro-dispersible Tablets 10mg & 20mg. Packed
tablets as required? in Alu-Alu blisters:
Ebastine Tablets 10mg
418DS01 January 2018 2500 Tablets
418DS03 February 2018 2500 Tablets

419DS04 March 2018 4000 Tablets
23 Do you have any criteria for fixing the batch The criteria for fixing the batch size of stability batches is
size of stability batches? the capacity of their R&D equipment where probable
simulation of manufacturing procedure of production
batches are expected as well as quantity of tablets
required per testing frequencies.
24 Do you have complete record of production The firm has complete record of production of stability
of stability batches? batches. All the Log Books are properly maintained.
25 Do you have protocols for stability testing The firm has detailed protocols for stability testing of
of stability batches? stability batches having protocol number:
Batch No. Protocol No.
418DS01 FS-019-18
418DS02 FS-020-18
418DS03 FS-021-18

419DS01 FS-022-18
419DS03 FS-023-18
419DS04 FS-024-18
method for testing of stability batches? testing of stability batches.
27 Do you have method transfer studies in case The firm has developed and validated method of testing
when the method of testing being used by for finished product and complete Method Validation
your firm is given by any other lab? Report is available. Therefore, method transfer is not
applicable.
28 Do you have documents confirming the The firm has proper documents confirming the
qualification of equipments / instruments qualification of equipment / instruments being used in the
being used in the test and analysis of test and analysis of Ebastine API and the finished drug.
Ebastine API and the finished drug?
29 Do your method of analysis stability The firm has performed forced degradation (FD) study on
indicating? their product Ebastine Oro-dispersible Tablets 10mg &
20mg for the conformance of its stability indicating
nature.
30 Do your HPLC software 21CFR Compliant? The HPLC software is 21CFR Compliant as per record

available with the firm. The firm have WATER‘s HPLC
with Empower 3 software having following features:
 Have Audit trail
 Have backup system
 Have Data traceability
 Have Data achieving system
 Have data integrity
 Have Data security
System Security Policy
31 Can you show Audit trail reports on Audit trail on the testing reports is available.
Ebastine testing?
32 Do you have some remaining quantities of The firm has remaining quantities of stability batches.
degradation products and stability batches?
33 Do you have stability batches kept on The firm has three stability batches kept on real time
stability testing? stability testing. 12 months real time stability data is
available.
equipments used in Ebastine tablets used in production and analysis of Ebastine Oro-
production and analysis? dispersible Tablets 10mg & 20mg.
35 Do proper and continuous monitoring and Adequate monitoring and control are available for
control are available for stability chamber? stability chamber. Chambers are controlled and
monitored through software having alarm system for
alerts as well.
36 Do related manufacturing area, equipment, Related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are in compliance.
compliant?
Conclusions:
for registration of Estine (Ebastine) 10mg & 20mg Oro-dispersible Tablets is verifiable to satisfactory
level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited
for the manufacturing of Estine 10mg & 20mg Oro-dispersible Tablets.
Recommendations:
The firm may kindly be granted necessary registration of Estine 10mg & 20mg Oro-dispersible tablets.
Decision: Registration Board decided to approve registration of ―Ebastine tablets 10 mg by M/s Getz
Pharma (Pvt) Ltd., Karachi, with the change in brand name. Manufacturer will place first three
production batches of the product on long term stability studies throughout proposed shelf life and on
941. Name and address of manufacturer / M/s Dyson research laboratories 28 km, Ferozepur Road
Applicant Lahore.
Brand Name +Dosage Form + Strength Dexal Capsule 30mg
Dexlansoprazole…30mg
Diary No. Date of R& I & fee Dy No. 143; 13-01-16 : Rs. 50,000/- (23-12-15)
Pack size & Demanded Price 10‘s: Rs. As per SRO
dosage form)
GMP status
Drug Dexal Capsule 30mg (Dexlansoprazole…30mg)
Name of Manufacturer M/s Dyson research laboratories 28 km, Ferozepur Road Lahore.
Manufacturer of API M/s Spansules Formulation, India
API Lot No. Dexlansoperazole DDR pellets 17.0% w/w. (Batch. # DLT/SF/0010117)
Description of Pack
Alu-PVC blister
Frequency Real Time: 0,1,3,6,9 Months(on going)
Accelerated: 0,1,3,6 Months
Batch No. T01 T02 T03
Batch Size 2200 Capsules
2200 Capsules 2200 Capsules

No. of Batches 03
Date of Submission Dy No.27052( 07-08-18)
No.
1. COA of API Yes
2. Approval of API by regulatory authority of The applicant has submitted the following documents:
country of origin or GMP certificate of API GMP Certificate:
manufacturer issued by regulatory authority of Issued to: M/s Spansules Formulations, India.
country of origin. Issued on: 05-09-2018
Issued by: Drug Control Administration, Telangana,
India.
Validity: One year from the date of Issue.
etc.
5. Documents confirming import of API etc. Applicant has submitted following:
Letter of Permission to import API signed by AD (I&E)
Lahore on 19-12-16.
Copy of commercial invoice for Dexlansoperazole
pellets 17%., attested by AD (I&E), DRAP Lahore on
03-02-2017 3.983 kgs.
data / documents.
Rules, 1978.
942. Name and address of manufacturer / M/s Dyson research laboratories 28 km, Ferozepur Road
Applicant Lahore.
Brand Name +Dosage Form + Strength Dexal Capsule 60mg
Dexlansoprazole…60mg
Diary No. Date of R& I & fee Dy No. 144; 13-01-16 : Rs. 50,000/- (25-12-15)
Pack size & Demanded Price 10‘s: Rs. As per SRO
dosage form)
GMP status
Drug Dexal Capsule 60mg (Dexlansoprazole 60mg)
Name of Manufacturer M/s Dyson research laboratories 28 km, Ferozepur Road Lahore.
Manufacturer of API M/s Spansules Formulation, India
API Lot No. Dexlansoperazole DDR pellets 17.0% w/w. (Batch. # DLT/SF/0010117)
Description of Pack
Alu-PVC blister
Frequency Real Time: 0,1,3,6,9 Months(on going)
Accelerated: 0,1,3,6 Months
Batch No. T01 T02 T03
Batch Size 2200 Capsules
2200 Capsules 2200 Capsules

No. of Batches 03
Date of Submission Dy No.27053, 07-08-18
No.
1. COA of API Yes
2. Approval of API by regulatory authority of The applicant has submitted the following documents:
country of origin or GMP certificate of API GMP Certificate:
manufacturer issued by regulatory authority of Issued to: M/s Spansules Formulations, India.
country of origin. Issued on: 05-09-2018
India.

etc.
5. Documents confirming import of API etc. Applicant has submitted following:
Letter of Permission to import API signed by AD (I&E)
Lahore on 19-12-16.
Copy of commercial invoice for Dexlansoperazole
pellets 17%., attested by AD (I&E), DRAP Lahore on
03-02-2017 for 3.983 kgs.
data / documents.
Rules, 1978.
Queries & Response of the firm
Sr. Queries Response of firm & its Evaluation by PEC
No.
1. Submit Approval of API/DML/GMP The applicant has submitted the following documents:
certificate of API manufacturer issued by GMP Certificate:
regulatory authority of country of origin as Issued to: M/s Spansules Formulations, India.
only Copy of DML has been submitted by the Issued on: 05-09-2018
firm. Issued by: Drug Control Administration, Telangana,
India.
2. API & working standards were purchased from In response to this query applicant has submitted a
M/s Spansules Formulations & Impurity statement by M/s Spansules Formulations which is stated
standard from Everest organics limited is used, below:
Clarify/Justify. With reference to our supply of Dexlansoperazole DDR
pellets to our customer M/s Dyson Research
Laboratories (Pvt) for their trial & stability studies, we
confirm that we are pellets manufacturer & we purchase
API Powder for pellets manufacturing from Indian
manufacturer M/s Everest Organic Ltd.
Hence our customer purchased impurities directly from
Everest Organics Ltd. On our recommendation.
3. You have submitted COA for In response to this query applicant has submitted a
Dexlansoperazole DDR pellets 17.0% w/w in statement by M/s Spansules Formulations which is stated
which the manufacturer of API did not below:
performed impurity profiling of pellets. With reference to our supply of Dexlansoperazole DDR
Clarify/Justify. pellets to our customer M/s Dyson Research
Laboratories (Pvt) for their trial & stability studies, we
confirm that we are pellets manufacturer in india &
pellets are ready to fill product made with the mixing
with several inactives so impurity profile cannot be
tested in biproduct. Since we have conducted stability
studies of pellets of Dexlansoprazole, impurities profile
was not required.
4. Batch numbers of trial batches for applied drug The Applicant has submitted its clarification:
product i.e. Dexal Capsule 30mg is T01, T02, We are using ―T‖-series for our trial batches only, in
T03 which is same to that of Dexal Capsule which numerical figures represents n = number of trials
60mg i.e. T01, T02, T03. Justify/Clarify how conducted (i.e. n= 1, 2, 3, 4, 5….). Furthermore,
the firm has distinguished between trial products can be identified against their strengths as
batches of two strength of applied drug Dexal capsule 30mg & 60mg respectively & labelling
product. for trail packs done accordingly to distinguish between
same products having different strengths.
5. Dissolution test at first month studies of all The applicant has submitted the following justification:
three trial batches of Dexal capsule 30mg & Dissolution test for trial batches T01, T02, T03,was not
Dexal capsule 60mg is not performed, Clarify. performed for Ist month only, while all other tests
including Assay were performed & were with Specified
limits. So you are requested to consider our stability
data for other months for evaluation. Since the
dissolution results of 0, 3 & 6 months (as per ICH
guidelines) comply with specifications; product anyhow
is stable as per reports of stability.
However, dissolution test at 3rd month in real Time
Stability studies has been carried out for only one trail
batch for Dexal capsule 30mg & 60mg.
Inspection Report M/s Dyson research laboratories 28 km, Ferozepur Road Lahore, applied for
registration of Dexal Capsule 30mg& Dexal Capsule 30mg with following composition:
Dexal Capsule 30mg
Dexlansoprazole…30mg, &
Dexal Capsule 60mg
Dexlansoprazole…60mg,
Chairman Registration Board constituted a three member panel for on-site investigation to confirm the
genuineness/authenticity of submitted stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc. Panel was requested to conduct inspection of the firm to verify the
submitted data by the firm and to submit a report on approved format for further consideration of case by the
Registration Board along with the clarification of following point.
Why the dissolution test at 3rd month of Real Time stability studies has not been carried out for two stability
batches for Dexal capsule 30mg (batch no. T02, T03) and Dexal capsule 30mg (batch no. T02, T03).
1. Director, DTL, Lahore
2. Area FID, Lahore.
3. Mst. Haleema Sharif, Assistant Director, PEC, DRAP, Islamabad.
documents, import of API, quality, specification, test analysis, facilities

also audited. The details of inspection is summarized as under:
Q.
No.

1. Do you have documents confirming the Dexlansoperazole pellets 17% w/w:
import of API including approval from Copy of commercial invoice stating following
DRAP? information is submitted by the firm.
ADC attestation date:03-02-2017
Exporter/manufacturer: M/s Spansules Formulations,
India.
Batch No. DLT/SF/0010117
Quantity: 3.983 Kgs
2. What was the rationale behind selecting the Supplier was qualified based on pre-shipment samples,
particular manufacturer of API? GMP certification, regulatory and documents compliant.
3. Do you have documents confirming the The firm imported Dexlansoerazole working standards
import of reference standard and impurity from Everest Laboratories (Manufacturer of
standards? Dexlansoprazole API) through Indentor Neon
Pharmaceuticals.
The firm has submitted Invoices for purchase & Air way
Bill for influx of Impurity Standards for both impurities:
Sulphide, Sulphone.
Invoice #: Exp/091/17-18
Sulphide;
Batch # Sulphide/WS-01/17
Mfg: 10/17
Quantity: 100mg
Sulphone;
Batch # Sulphone/WS-01/17
Mfg: 10/17
Quantity: 100mg
4. Do you have certificate of Analysis of the The firm has submitted COAs of following APIs as
API, reference standards and impurity obtained from source mentioned below:
standards? Dexlansoperazole pellets
5. Do you have GMP certificate of API The applicant has submitted the following documents:
manufacturer issued by regulatory authority GMP Certificate:
of country of origin? Issued to: M/s Spansules Formulations, India.
Issued on: 05-09-2018
India.
6. Do you use API manufacturer‘s method of The firm stated that they have used API testing method of
testing for testing API? source that is M/s Spansules Formulations, India.
7. Do you have stability studies reports on API? Yes
8. If yes, whether the stability testing has been Yes the stability testing has been performed as per SIM
performed as per SIM method and method and degradation products have been quantified
9. Do you have method for quantifying the The firm has method for calculating/quantify known
impurities in the API? impurities in API.
10. Do you have some remaining quantities of the The firm has some remaining quantities of the API,
API, its reference standard and impurities reference standard and impurities standards (sulphone &
standards? shulphide Impurity standards).
11. Have you used pharmaceutical grade No excipients have been used in the manufacturing of
excipients? applied formulation

12. Do you have documents confirming the Firm has used ready to fill (semi-finished)
import of the used excipients? dexlansoperazole pellets for fabrication of applied
formulation; No excipients have been used in the
manufacturing of applied formulation.
13. Do you have test reports and other records on Firm has used ready to fill (semi-finished)
the excipients used? dexlansoperazole pellets for fabrication of applied
formulation; No excipients have been used in the
manufacturing of applied formulation.
14. Do you have written and authorized protocols The firm has written and authorized protocols for the
for the development of Dexal 30mg & 60mg development of Dexal 30mg & 60mg Capsule.
Capsule?
15. Have you performed Drug-excipients N/A ( Since firm is refilling pellets in capsules)
16. Have you performed comparative dissolution The firm has not performed comparative dissolution
studies? studies at three pH values that are 1.2, 4.5 and 6.8.
Instead, they have performed comparative studies with the
Innovator Product Dexilant capsule 30mg.
Batch #: 1503372
Mfg date: 12-2019
Exp date: 11-2019
17. Do you have product development (R&D) Yes, the firm has product development (R&D) section.
section
18. Do you have necessary equipment available Yes, the firm has necessary equipment in R & D section
in product development section for though filling for the development of for Dexal 60 mg
development of Dexal 30mg & 60mg Capsule has been carried in General Production Capsule
Capsule? Section of the firm having commercial scale Capsule
filling machine.
19. Are the equipment in product development The equipment used in production and analysis of trial
section qualified? batches are qualified.
20. Do you have proper The firm has Internal & External calibration program for
maintenance/calibration/re-qualification the equipment used in production and QC.
program for the equipment used in PD
section?
21. Do you have qualified staff in product Yes , the firm has qualified staff in product development
and training in product development? development
22. Have you manufactured three stability batches The firm has manufactured following three stability
for the stability studies of Dexal 30mg & batches for the stability studies of Dexal 30mg & 60mg
60mg Capsule as required? Capsule
S. No. Stability Batches Batch Sizes
a. T-01 2,200
b. T-02 2,200
c. T-03 2,200
23. Do you have any criteria for fixing the batch
The criteria for fixing batch size depend on the quantity
size of stability batches? required for stability testing.
24. Do you have complete record of production of
The firm has complete record of production of stability
25. Do you have protocols for stability testing of
The firm has controlled protocol of testing of stability
stability batches? batches of applied formulation at 30 Co+ 2 Co & 65 % RH
+ 5 % with them for real time studies and at 40 Co+ 2 Co
& 75 % RH + 5 % for accelerated studies.
26. Do you have developed and validated the The firm has adopted a Supplier method for testing of
method for testing of stability batches? finished product which has been used in the stability

studies. The firm has also submitted a report verifying the
validation studies of the analytical method covering
following parameters of validation:
i. Specificity
ii. Linearity
iii. Precision
iv. Ruggedness
27. Do you have method transfer studies in case The firm has not conducted method transfer studies.
when the method of testing being used by According to the firm they have developed their method
your firm is given by any other lab? of testing in their own laboratory hence no need of such
method transfer studies.
28. Do you have documents confirming the The firm showed documents confirming the qualification
used in the test and analysis of APIs and the analysis of APIs and the finished drug.
finished drug
29. Do your method of analysis stability The firm method of testing is stability indicating which
indicating? has been used in stability studies of their finished product.
The firm has conducted impurity testing one time at 6
month time point.
30. Do your HPLC software is 21CFR compliant? Firm has 1 HPLC dedicated for R&D testing at the time
of studies conducted and it is 21 CFR compliant. This
HPLC system is used for stability studies of Dexal 30mg
& 60mg Capsule. The HPLC used for the stability studies
is 21-CFR compliant. However, the record from
logbooks, analytical test reports was randomly found
verifiable onsite. A complete trail of such testing was
found available and verifiable.
31. Can you show Audit Trail reports on Dexal A complete trail of such testing was found available and
30mg & 60mg Capsule testing? verifiable from and software of HPLC.
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches.
33. Do you have stability batches kept on stability The firm has completed the accelerated stability testing on
testing? the three stability batches of Dexal 30mg & 60mg
Capsule. Also the firm has stability batches kept on
stability testing for the real time stability testing up to 12
months on all three batches of Dexal 30mg & 60mg
Capsule.
34. Do you have valid calibration status for the The firm has valid calibration status for the equipments
equipments used in production and analysis? used in production and analysis of Dexal 30mg & 60mg
Capsule as per record available during onsite visit.
35. Do proper and continuous monitoring and Continuous power supply and monitoring with back up
control are available for stability chamber? from generator and UPS are available for stability
chamber to address the problem of interrupted power
supply or load shedding. Digital data loggers are available
for continuous monitoring of temperature and humidity
conditions of stability chamber.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are rated as GMP compliant.
compliant?
37. ―Dissolution test at 3rd month of Real Time 1. Dissolution testing of batch No. T02 & T03 of
stability studies has not been carried out for both strengths 30 mg & 60 mg for real time study at 3rd
two stability batches for Dexal capsule 30mg month was missed unintentionally by confusion.
(batch no. T02, T03) and Dexal capsule 30mg 2. Testing of dissolution of batch No. T01 for both
(batch no. T02, T03).‖ strengths 30 mg & 60 mg may be considered instead

because the skipped batches have the same granules filled
in capsules and maintained at real time study condition.
3. All other tests for T02 & T03 were performed on
3rd month, & were within limits.
4. We have submitted 9 months study of real time
stability where T02 & T03 complied all the specifications,
through 9 months period.
5. In the light of point 4, batch No T02 & T03
Complied dissolution specs at 6th & 9th months so
though unintentional skipping of test at 3rd month was
done but product is showing valid stability results.
Company humbly request to consider all other testing at
all time points a valid stability of products & grant please
registration accordingly.
Conclusion & Recommendations

The firm was also advised to keep record of raw data of the stability testing.
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Dexal Capsule 30mg & Dexal Capsule 60mg is verifiable to a satisfactory
level. The related manufacturing area, equipment, personnel and utilities are GMP compliant and
suitable for the manufacturing of Dexal Capsule 30mg & Dexal Capsule 60mg, therefore, the panel
recommends the registration of above stated product in the name of the manufacturerM/s Dyson
research laboratories 28 km, Ferozepur Road Lahore.
Decision: Registration Board decided to approve registration of ―Dexal Capsule 30mg & Dexal Capsule
60mg (Dexlansoprazole) by M/S. Dyson research laboratories, Lahore. Manufacturer will place first three
b. EXEMPTION FROM ONSITE VERIFICATION OF STABILITY DATA

943. Name and address of manufacturer / M/s Highnoon Laboratories, 17.5 Km, Multan Road, Lahore.
Applicant
Brand Name +Dosage Form + Strength Apiban 2.5mg tablet
Apixaban …… 2.5mg
Pharmacological Group Antithrombotic agents
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s,20‘s, 30‘s
Me-too status Not available
GMP status GMP certificate based upon evaluation conducted on 6-7-2017
Remarks of the Evaluator  Firm has submitted Form 5-D (dated 20-12-2017)
alongwith differential fee of Rs. 30,000/-
 Stability data as per directions of 251st meeting of
Registration Board shall be submitted.
submission of stability studies data as per directions of 251st
Evaluation by PEC Now the firm has submitted stability studies of the applied
formulation.
Drug Apiban 2.5mg tablet
Name of Manufacturer M/s Highnoon Laboratories, 17.5 Km, Multan Road, Lahore.
th
API Lot No. Lot No. 1704002291
Description of Pack
Alu-alu blister
Time Period Accelerated: 06month
Real Time: 06month
Real Time: 0,3,6 (Month)& ongoing
Batch No. RD-18101 RD-18102 RD-18103
Batch Size 7,600 Tabs 7,600 Tabs 7,600 Tabs
No. of Batches 03
Date of Submission
No.
1. COA of API Applicant has submitted Photocopy of COA of
Apixaban having following information on it.
For API Apixaban:
Batch No: 1704002291
Manufacturer:M/s Alembic Pharmaceuticals
Limited, India.
2. Approval of API by regulatory authority of country Firm has submitted following:
of origin or GMP certificate of API manufacturer Copy of GMP certificate for Apixaban
issued by regulatory authority of country of origin. Manufacturer:
Issued To: M/s. Alembic Pharmaceuticals, India.
Issued By: Food & Drug Administration,
Gandhinagar, Gujrat State, India.
Issued On: 02 August, 2016
Valid up till: 01-08-2018.
5. Documents confirming import of API etc. Applicant has submitted ADC attested invoice
stating following information on it:
For Apixaban:
Invoice #: 90046555 (dated: 20-09-2017)
Manufacturer of API: M/s. Alembic
Pharmaceuticals Ltd., India, Survey No. 842, 843,
Vill. Karakhadi, Tal.Padra, Dist. Vadodara-391450,
Gujarat, India.
Quantity of API: 1kg
Lot No. 1704002291
Cleared on/Attested on: 16-01-18
documents.
1978.
Apixaban 2.5mg Tablets
01 Reference of last onsite panel Firm has quoted the onsite panel inspection for Nebvax (Nebivolo +
inspection for instant dosage form Valsartan) 5/80mg Tablet, Daplozmet 5/850mg Tablet & Daplozmet
conducted during last two years. 5/1000mg Tablet conducted on 1st January, 2019 & presented in
288th RB meeting as a reference inspection for instant dosage form.
1. Is your HPLC Audit trail was active on all HPLC
software 21CFR systems used in the method
compliant? validation and stability study.
Individual user log in and IDs were
available.
2. Is proper and Yes, monitoring and control was
continuous monitoring available for the stability chambers
and control available provided.
for stability chamber? Firm was advised to install alarm
system in stability chamber and
perform challenge test.
02 Documents for the procurement of Applicant has submitted ADC attested invoice stating following
API with approval from DRAP (in information on it:
case of import). For Apixaban:
Invoice #: 90046555 (dated: 20-09-2017)
Manufacturer of API: M/s. Alembic Pharmaceuticals Ltd., India,
Survey No. 842, 843, Vill. Karakhadi, Tal.Padra, Dist. Vadodara-
391450, Gujarat, India.
Lot No. 1704002291
03 Documents for the procurement of .
standards.
04 Approval of API/ DML/GMP Firm has submitted following:
certificate of API manufacturer Copy of GMP certificate for Apixaban Manufacturer:
issued by regulatory authority of Issued To: M/s. Alembic Pharmaceuticals, India.
country of origin. Issued By: Food & Drug Administration, Gandhinagar, Gujrat State,
India.
05 Mechanism for Vendor pre- Firm has submitted Vendor Qualification Flow Chart.
qualification.
06 Certificate of analysis of the API, For API Apixaban:
reference standards and impurity Photocopy of COA of Batch No. 1704002291 issued by M/s
standards. Alembic Pharmaceuticals Limited, India is submitted.
Working standards:
The firm has submitted the copy of COA of working Standards
(Apixaban) Batch No. WS/APN/001, Quantity 0.2gm, provided by
the API Manufacturer - M/s Alembic Pharmaceuticals Limited,
India is submitted.
07 Documents for the procurement of Firm has submitted documents for procurement of excipients used
excipients used in product in product development.
development?
08 List of qualified staff involved in Firm has submitted list of 06 qualified person working in R&D
experience.
PRODUCTION DATA
09 Authorized Protocols / SOP for the The firm has submitted copy of generalized SOP with the title
development & stability testing of ‗Product Design & Development‟, Effective Date: 10th April,2017,
trial batches. & Analytical method for testing of API & FPP.
10 Complete batch manufacturing Firm has provided batch manufacturing record of all the three
BATCH MFG. MFG.
BACH SIZE
NO . STARTED COMPLETED
RD-
7,600 Tabs 02-05-2018 03-05-2018
18101
RD-
7,600 Tabs 02-05-2018 03-05-2018
18102
RD-
7,600 Tabs 02-05-2018 03-05-2018
18103
11 Record of remaining quantities of Firm has submitted following remaining quantities:
stability batches. Apixaban 2.5mg Tablets; Stability Pack Size : 2 x 14‘s)
 RD-18101: Batch Size : 7,600 Tablets
Number of tablets blistered: 400
12 Packs placed on stability (Accelerated: 03 Packs, Real Time
: 09 Packs), out of which 01 pack are remaining Accelerated
and 06 Packs remaining Real Time.
QA/QC DATA
12 Record of Digital data logger for Firm has submitted record of digital data logger for temperature
temperature and humidity and humidity monitoring control for the complete stability period.
(Real Time and Accelerated)
13 Method used for analysis of API Firm has provided the method used for analysis of API along with
along with COA. its certificate of analysis.
14 Method used for analysis of FPP & Firm has provided method used for analysis of FPP and complete
complete record of testing of record of testing of stability batches including chromatograms, lab
stability batches (i.e. reports and raw data sheets are submitted with 06 months
chromatograms, lab reports, raw data Accelerated stability data and 06 months Real Time Stability
sheets etc.) Data.
15 Reports of stability studies of API APIXABAN: The firm has submitted copy of Accelerated 06
from manufacturer. Months (40°C ± 2°C & 75±5%RH) stability study reports of 03
batches of Apixaban from M/s Alembic Pharmaceuticals Ltd.,
India, Survey No. 842, 843, Village Karakhadi, Taluk-Padra,
District-Panchmahal Vadodara-391450, Gujarat, India.
16 Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients used in
the applied formulation.
17 Drug-excipients compatibility The firm has submitted Drug-excipients compatibility studies
studies.
18 Record of comparative dissolution Firm has submitted comparative dissolution profile with the
data. reference product Eliquis 2.5mg Tablet, Bristol-Myers Squibb,
USA.
REFERENCE PRODUCT OF
FEATURE
PRODUCT HIGHNOON
BRAND Eliquis 2.5mg Tabs. Apixaban 2.5mg Tabs.
NAME
BATCH # AAM5629 RD-18102
MFG/EXPIR Mfg. Date: 08-2016 Mfg. Date: 05-2018
Y Exp. Date: 07-2019 Exp. Date: 05-2020
19 Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR
software 21CFR & audit trail reports & audit trail reports.
on product testing.
Evaluation by PEC:
Sr. Deficiencies Justification
No.
1. Documents for the procurement of reference The related substances in API % FPP are evaluated
standard and impurity standards are not by the validated method the related substance is
submitted, clarify/Justify calculated by relative retention time which does not
require impurity standard. For identification of the
known impurities (Impurity A, Impurity B,
Impurity C, Impurity D) the relative retention time
(i.e. with reference to Apixaban: Impurity A= about
2.19; Impurity B= about 0.45; Impurity C= about
1.26; Impurity D= about 2.82; Apixaban= about
1.00) is used. The API Manufacturer testing
procedure and highnoon method of testing for
finished product are attached for reference A-1.
2. Batch size for each of three trials is 3800 tablets Total Tablets required for
as per you reconciliation sheet; out of which Dissolution=6
400 tablets are blistered, 350 tablets were kept Disintegration=6
on stability. Assay/Purity=30
Justify/clarify that 350 tablets are sufficient for Total Tablets=42
test/ analysis of each of the trials at all time Total Intervals (Real Time Stability)=6
points up till proposed shelf life. Moreover, Total Intervals (Accelerated Stability)=2
where the remaining tablets which were not Total Intervals=8
blistered were kept? Total Tablets Required=8*42=336
So total 350 tablets are placed in stability and the
no of required tablets for testing are 336 and
remaining quantities of the tablets are with the
product Development Department.
3. Analytical method used for test/analysis of The method is in-house and is validated. The
applied drug product is in house or supplier, analytical method validation report was submitted
Clarify. in file no.1, Annex 13. However a copy of report is
enclosed.
4. Submit stability data of API by its The stability data is enclosed.
manufacturer, as it is not submitted.
5. Time intervals for sampling in CDP are 10, 20, As per item 10.3.3 of WHO Technical Report series
30, & 45 minutes, which are different from that No.992, 2015, Annes & Multisource (generic)
recommended by guidelines, clarify/justify. pharmaceutical products; guidelines on registration
requiremets to establish interchangeability.
―10.3.3 Disssolution profile comparison for
biowavers based on dose-proportionality of
formulation
As for biowaivers based on BCS, a model
independent mathematical approach (e.g. F2 test)
can used for comparing the dissolution profiles fo
two products. The dissolution of the two products

(reference strength and additional strength) should
be measured under the same test condition. The
dissolution sampling times for both reference
strength and additional strength profiles should be
the same for example.
 Fro immediate release products
5,10,15,20,30,45 and 60 minutes.
 For 12 hour extended release products
1,2,4,6,8 and 12 hours
 For 24 hour extended release products
1,2,4,6,8,16 and 24 hours.
6. Evidence of purchase of reference product Receipt for Eliquis purchase (enclosed)
eliquis for CDP.
7. Submit chromatograms for 3rd month The chromatograms are attached in Annexure 16 of
accelerated stability studies for all three trial already submitted file NO.2. However copies of
batches. chromatogram for 3rd month accelerated stability
studies for all three trial batches are attached for
your reference.
8. According to information on chromatograms: In Due to overload of work the testing of batch was
initial studies of batch 18101, Assay is planned in parts according to the availability of the
performed on 29th May, 2018 & dissolution on equipment. Therefore after performing assay testing
2nd June 2018, clarify/justify before further on 29th of May, 2018 dissolution testing was
processing of the case. planned on 2nd June 2018.
Decision: Registration Board decided to defer the case for confirmation of audit trail of HPLC analysis
For stability studies of all three trial batches of applied product & clarification as all three trials of both
stregths of Apiban tablet 2.5mg & 5mg have same audit trial in terms of date & time at all time intervals
for all injections of sample & standard, by Area FID and respective evaluator, PEC.
944. Name and address of manufacturer / M/s Highnoon Laboratories, 17.5 Km, Multan Road, Lahore.
Applicant
Brand Name +Dosage Form + Strength Apiban 5mg tablet
Apixaban …… 5mg
Pharmacological Group Antithrombotic agents
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s,20‘s, 30‘s
Me-too status Not available
GMP status GMP certificate based upon evaluation conducted on 06-07-
2017.
Remarks of the Evaluator  Firm has submitted Form 5-D (dated 20-12-2017)
alongwith differential fee of Rs. 30,000/-
 Stability data as per directions of 251st meeting of
Registration Board shall be submitted.
submission of stability studies data as per directions of 251 st
Evaluation by PEC Now the firm has submitted stability studies of the applied
formulation.
Drug Apiban 5mg tablet
Name of Manufacturer M/s Highnoon Laboratories, 17.5 Km, Multan Road, Lahore.
API Lot No. Lot No. 1704002291

Description of Pack
2×14‘s: Alu-alu blister
Time Period Accelerated: 6 Month
Real Time: 6 Month
Batch No. RD-18092 RD-18093 RD-18094
Manufacturing Date 05, 2018 05, 2018 05, 2018
Date of Initiation 06, 2018 06, 2018 06, 2018
No. of Batches 03
Date of Submission
No.
1. COA of API Applicant has submitted Photocopy of COA of
Apixaban having following information on it.
For API Apixaban:
Batch No: 1704002291
Manufacturer:M/s Alembic Pharmaceuticals
Limited, India.
2. Approval of API by regulatory authority of country Firm has submitted following:
of origin or GMP certificate of API manufacturer Copy of GMP certificate for Apixaban
issued by regulatory authority of country of origin. Manufacturer:
Issued To: M/s. Alembic Pharmaceuticals, India.
Issued By: Food & Drug Administration,
Gandhinagar, Gujrat State, India.
5. Documents confirming import of API etc. Applicant has submitted ADC attested invoice
stating following information on it:
For Apixaban:
Invoice #: 90046555 (dated: 20-09-2017)
Manufacturer of API: M/s. Alembic
Pharmaceuticals Ltd., India, Survey No. 842, 843,
Vill. Karakhadi, Tal.Padra, Dist. Vadodara-391450,
Gujarat, India.
Lot No. 1704002291
documents.
th
1978.
Apixaban 5mg Tablets
01 Reference of last onsite panel Firm has quoted the onsite panel inspection for Nebvax
inspection for instant dosage form (Nebivolo + Valsartan) 5/80mg Tablet, Daplozmet 5/850mg
conducted during last two years. Tablet & Daplozmet 5/1000mg Tablet conducted on 1st January,
2019 & presented in 288th RB meeting as a reference inspection
for instant dosage form.
1. Is your HPLC Audit trail was active on all
software 21CFR HPLC systems used in the
compliant? method validation and stability
study. Individual user log in
and IDs were available.
2. Is proper and Yes, monitoring and control
continuous monitoring was available for the stability
and control available chambers provided.
for stability chamber? Firm was advised to install
alarm system in stability
chamber and perform
challenge test.
02 Documents for the procurement of API Applicant has submitted ADC attested invoice stating following
with approval from DRAP (in case of information on it:
import). For Apixaban:
Invoice #: 90046555 (dated: 20-09-2017)
Manufacturer of API: M/s. Alembic Pharmaceuticals Ltd.,
India, Survey No. 842, 843, Vill. Karakhadi, Tal.Padra, Dist.
Vadodara-391450, Gujarat, India.
Lot No. 1704002291
03 Documents for the procurement of
standards.
04 Approval of API/ DML/GMP Firm has submitted following:
certificate of API manufacturer issued Copy of GMP certificate for Apixaban Manufacturer:
by regulatory authority of country of Issued To: M/s. Alembic Pharmaceuticals, India.
origin. Issued By: Food & Drug Administration, Gandhinagar, Gujrat
State, India.
05 Mechanism for Vendor pre- Firm has submitted Vendor Qualification Flow Chart.
qualification.
06 Certificate of analysis of the API, For API Apixaban:
reference standards and impurity Photocopy of COA of Batch No. 1704002291 issued by M/s
standards. Alembic Pharmaceuticals Limited, India is submitted.
Working standards:
The firm has submitted the copy of COA of working Standards
(Apixaban) Batch No. WS/APN/001, Quantity 0.2gm, provided
by the API Manufacturer – M/s Alembic Pharmaceuticals
Limited, India is submitted.
07 Documents for the procurement of Firm has submitted documents for procurement of excipients
excipients used in product used in product development.
development?
08 List of qualified staff involved in Firm has submitted list of 06 qualified person working in R&D
experience.
PRODUCTION DATA
09 Authorized Protocols / SOP for the The firm has submitted copy of generalized SOP with the title
development & stability testing of trial ‗Product Design & Development‘, Effective Date: 10 th April,
batches. 2017, & Analytical method for testing of API & FPP.
10 Complete batch manufacturing record Firm has provided complete batch manufacturing record of all
of three stability batches. the three batches
MFG.
BATCH BACH MFG.
COMPLET
NO . SIZE STARTED
ED
RD-18092 3,800 Tabs 02-05-2018 03-05-2018
RD-18093 3,800 Tabs 02-05-2018 03-05-2018
RD-18094 3,800 Tabs 02-05-2018 03-05-2018
11 Record of remaining quantities of Firm has submitted following remaining quantities:
stability batches. Apixaban 5mg Tablets; Stability Pack Size : 2 x 7‘s)
23 Packs placed on stability (Accelerated: 06 Packs, Real
Time : 17 Packs), out of which 01 pack are remaining
Accelerated and 12 Packs remaining Real Time.
QA/QC DATA
12 Record of Digital data logger for Firm has submitted record of digital data logger for temperature
temperature and humidity monitoring and humidity monitoring control for the complete stability
of stability chambers (Real Time and period.
Accelerated)
13 Method used for analysis of API along Firm has provided the method used for analysis of API along
with COA. with its certificate of analysis
14 Method used for analysis of FPP & Firm has provided method used for analysis of FPP and
complete record of testing of stability complete record of testing of stability batches including
batches (i.e. chromatograms, lab chromatograms, lab reports and raw data sheets are submitted
reports, raw data sheets etc.) with 06 months Accelerated stability data and 06 months Real
Time Stability Data.
15 Reports of stability studies of API APIXABAN: The firm has submitted copy of Accelerated 06
from manufacturer. Months (40°C ± 2°C & 75±5%RH) stability study reports of 03
batches of Apixaban from M/s Alembic Pharmaceuticals Ltd.,
India, Survey No. 842, 843, Village Karakhadi, Taluk-Padra,
District-Panchmahal Vadodara-391450, Gujarat, India.
16 Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients used in
17 Drug-excipients compatibility studies. The firm has submitted Drug-excipients compatibility studies
18 Record of comparative dissolution Firm has submitted comparative dissolution profile with the
data. reference product Eliquis 5mg Tablet, Bristol-Myers Squibb,
USA.
REFERENCE PRODUCT OF
FEATURE
PRODUCT HIGHNOON
BRAND NAME Eliquis 5mg Tabs. Apixaban 5mg Tabs.
BATCH NO. AAX1407 RD-18093
MFG./ EXPIRY Mfg. Date: 01-2018 Mfg. Date: 05-2018
DATE Exp. Date: 12-2020 Exp. Date: 05-2020
19 Compliance Record of HPLC software Firm has submitted compliance record of HPLC software 21
21CFR & audit trail reports on product CFR & audit trail reports.
testing.
Evaluation by PEC:
Sr. Deficiencies Justification
No.
1. Submit Valid copy of GMP certificate of API The GMP certificate for Apixaban (1809992) issued
Manufacturer issued by concerned regulatory to alembic pharmaceutical Ltd, Valid up to 05-9-
authority of country of origin, as it is not valid 2021 is attached.
now.
2. Batch size for each of three trials is 7600 tablets Total Tablets required for
as per your reconciliation sheet; out of which Dissolution=6
400 tablets are blistered, 364 tablets were kept Disintegration=6
on stability. Assay/Purity=30
Justify/clarify that 364 tablets are sufficient for Total Tablets=42
test/ analysis of each of the trials at all time Total Intervals (Real Time Stability)=6
points up till proposed shelf life. Moreover, Total Intervals (Accelerated Stability)=2
where the remaining tablets which were not Total Intervals=8
blistered were kept? Total Tablets Required=8*42=336
So total 364 tablets are placed in stability and the no
of required tablets for testing are 336 and remaining
quantities of the tablets are with the Product
Development Department.
3. Documents for the procurement of following All the above excipients are procured from local
excipients; macrogol 600, lactose anhydrous, vendors and their COAs are submitted in Annex 12
polysorbate 80, titanium dioxide, iron oxide of already submitted file 1. The copies of COAs for
yellow, colloidal silicon dioxide are not your reference are enclosed.
submitted.
4. Submitted stability data of API by its The stability data is enclosed.
Manufacturer, as it is not submitted.
5. Trial RD-18092 , RD-18093 & RD-18094 is Due to overload of work the testing of batch was
prepared on 2nd May 2018 & assay testing is planned in parts according to the availability of the
carried out on 29th May 2018 & dissolution on equipment. Therefore after performing assay testing
2nd June 2018 as per information on on 29th of May, 2018 dissolution testing was planned
chromatograms, Clarify/Justify, on 2nd June 2018.
6. Chromatograms for Trial RD-18092 & RD- The batch numbers mentioned on sample
18093 at initial studies are not of applied drugchromatograms are as per batch numbers were
product instead they are of some other mentioned collectiverly because same standard is
formulation & contain a different batch number, used against multiple samples analysed on same day.
Clarify/Justify before further processing of case.
As products development has developed different
formulations other thatn those formulation submitted,
so batch numbers of those trials (formulation) were
also mentioned on standards.
7. Chromatogram for blank solution for trial 18093 Based on your query we reviewed chromatogram of
at 6th month Accelerated Stability Studies blank. As the diluents may have very minor residues
shows some upward & downward peaks. therefore for the ease of review its scale is
Clarify/Justify normalized at 1 mAU along Y axis whereas in
sample chromatogram due the very high
concentration of solute its scale is normalized at 80

mAU along y-axis. So the baseline looks like that due
to low scale )1/80th of the scale used for sample.) For
understanding thechromatogram of blank solution
normalized at 80 mAU is attached check A-4.
8. Baseline for reference standards is not stable. Based on your we reviewed all datat and we found
Clarify/Justify. that in the chromatogram of reference solution of
related substances, there is low concentration , its
scale is normalized at 10mAU along Y axis whereas
in sample chromatogram due to very high
concentration its scale is noramlized at 1700mAU
along y-axis. So the baseline looks like that at low
scale. For understanding the chromatogram of
reference solution narmalized at 1700mau is attached.
9. Date & time for both strengths of Apixaban As the manufacturing of both strengths of
2.5mg & 5mg tablet are same as per Apixaban2.Smg &5mg are same as well as testing
chromatograms & Audit trail. Justify/Clarify. procedure is also same so we planned their analysis
at same date and time
Decision: Registration Board decided to defer the case for confirmation of audit trail of HPLC analysis.
For stability studies of all three trial batches of applied product & clarification about how it is possible for
all three trials of both stregths of Apiban tablet 2.5mg & 5mg to have same audit trial in terms of date &
time at all time intervals for all injections of sample & standard, by Area FID and respective evaluator,
PEC.
945. Name and address of manufacturer / Genix Pharma (Pvt.) Ltd, Karachi
Applicant
Brand Name +Dosage Form + Strength Empag M 12.5mg + 1000mg Tablets
Composition Each Extended Release Film Coated Tablet Contains: -
Empagliflozin ……12.5mg
Metformin hydrochloride…1000mg
Diary No. Date of R& I & fee Dy No.34140; 15-10-2018: 50,000/- ; 09-10-18
Pharmacological Group Anyti-diabetic
Type of Form Form-5
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 28‘s, 30‘s As per SRO
Regulatory Authorities. (Synjardy XR Tablet)
Me-too status N/A
GMP status In the light of inspected areas, facilities status of equipment
and hygiene and sanitation of area and equipment, control
procedures and documentations, internal and external
inspection and audit reports safety of the workers, stability
protocols and data, product development, recalls and
complaints handling & other CGMP issues, M/s Genix
Pharma Pvt. Ltd Karachi was considered at an satisfactory
level of compliance with CGMP GUIDLINES as of today.
The management was also suggested to further strengthen
stability and analytical sections
Drug Empag M 12.5mg /1000mg Tablets
Name of Manufacturer Genix Pharma (Pvt.) Ltd, Karachi
Manufacturer of API For Empagliflozin:
M/s WIS Pharmatech Co., Ltd. Factory, Manufactured by M/s Ruyuan HEC
Pharm Co., Ltd. China has been submitted.
For Metformin HCl: M/s Wanbury Limited, India
API Lot No. Empagliflozin: Lot #: EGLZ-RD20171101A
Metformin Hydrochloride Lot #: MT00600118

Description of Pack Alu /alu Blister Pack in Unit carton
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. 18SB-103-01 18SB-104-02 18SB-105-03
Date of Initiation 26-06-2018

No. of Batches 03
Date of Submission
No.
1. COA of API. Photocopy of COAs of Empagliflozin
&Metformin hydrochloride for following batches
have been submitted.
Particulars Batch No.
Empagliflozin EGLZ-RD20171101A
Metformin Hydrochloride MT00600118
2. Approval of API by regulatory authority of country Applicant has submitted the following:
of origin or GMP certificate of API manufacturer For Empagliflozin:
issued by regulatory authority of country of origin. GMP Certificate No: 2018024
Issued to: Ruyuan HEC Pharm Co., LTD
Issued by: Shaoguan Food & Drug
Administration
Validity: Until 18-12-2019
For Metformin HCl:

5. Documents confirming import of API etc. Applicant has submitted the following:
For Empagliflozin:
Copy of commercial Invoice declaring following
information on it:
Invoice No: WIS170152
Attested by: ADC Karachi
Attested on: 07-12-2017
Quantity: 0.75 Kg
From: M/s WIS Pharmatech Co., Ltd. Factory,
Manufactured by M/s Ruyuan HEC Pharm Co.,
Ltd. China.
For Metformin HCl:
Copy of commercial Invoice declaring following

information on it:
Invoice No: EXP/92001577/ 17-18
Quantity: 5000 Kg
From: M/s Wanbury Limited, India.
documents.
1978.
Data for Exemption from onsite investigation
Reference of last onsite panel Firm has referred to onsite inspection report of their Product
1. inspection for instant dosage ―WYMLY Tablets 25mg (Tenofovir Alafenamide)‖, which was
form conducted during last two conducted on 06-02-2018, and was presented in 281st meeting of
years. Registration Board held on 11-13th April, 2018. Registration Board
decided to approve registration of WYMLY Tablets 25mg (Tenofovir
Alafenamide), of M/s. Genix Pharma (Pvt.) Ltd., Karachi.
Following two points are reported inside the above stated inspection
report:
 The HPLC software is 21CFR complaint and having
certificates of compliance by USFDA.
 Audit trail on the testing reports of WYMLY Tablets 25mg
(Tenofovir Alafenamide) is available.
(Adequate monitoring and control are available for stability chamber.
Chamber are controlled and monitored through software having alarm
system for alerts as well).
Documents for the procurement Applicant has submitted the following:
2. of API with approval from For Empagliflozin:
DRAP (in case of import). Copy of commercial Invoice declaring following information on it:
Invoice No: WIS170152
Quantity: 0.75 Kg
From: M/s WIS Pharmatech Co., Ltd. Factory, Manufactured by M/s
Ruyuan HEC Pharm Co., Ltd. China has been submitted.
For Metformin HCl:
Copy of commercial Invoice declaring following information on it:
Invoice No: EXP/92001577/ 17-18
Quantity: 5000 Kg
From: M/s Wanbury Limited, India

Documents for the procurement For Empagliflozin:
3. of reference standard and The firm has submitted copy of letters from M/s Ruyuan HEC Pharm
impurity standards. Co., Ltd. China in the name of M/s Genix Pharma (Pvt.) Ltd, Karachi,
declaring the submission of following reference standards.
Particulars Batch No. Quantity
Working standard EGLZ-WS201612101 2gm
For Metformin HCl:
M/s USP 7135 English Muffin Way Frederick, MD 21704, USA in the
name of M/s Genix Pharma (Pvt.) Ltd, Karachi, declaring the
submission of following reference standards.
Particulars Batch No. Quantity
Working standard -------- 200mg
Approval of API/ DML/GMP Applicant has submitted the following:
4. certificate of API manufacturer For Empagliflozin:
issued by regulatory authority of GMP Certificate No: 2018024
country of origin. Issued to: Ruyuan HEC Pharm Co., LTD
Issued by: Shaoguan Food & Drug Administration
Validity: Until 18-12-2019
For Metformin HCl:
Mechanism for Vendor pre- The firm has submitted photocopy of ―SOP for Selection of
5. qualification manufacturer for Vendor Certification.
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of ―Vendor‘s Audit form‖ filled for M/s Ruyuan HEC Pharm
Co., Ltd. China.
Copy of ―Vendor‘s Audit form‖ filled for M/s Wanbury Limited.
India.
Certificate of analysis of the Photocopy of COAs of Empagliflozin, working standards and impurity
6. API, reference standards and standards issued by M/s Ruyuan HEC Pharm Co., Ltd. China. & M/s
impurity standards USP 7135 English Muffin Way Frederick, MD 21704 is submitted.
Detail is as under :
Particulars Batch No
Empagliflozin EGLZ-RD20171101A
Metformin MT00600118
Hydrochloride
Working Standards
Empagliflozin EGLZ-WS201612101
Metformin HCl R069H0
Impurity Standards
Melamine GIM492
Metformin Related R072Y0
Compound A
Documents for the procurement The firm has submitted photocopy of Purchase Order/Invoices for the
7. of excipients used in product procurement of excipients used in product development.
development?
List of qualified staff involved in The firm has submitted photocopy of List of qualified staff involved in
8. product development with product development comprising of 04 members.
Production Data
Authorized Protocols/SOP for The firm has submitted photocopy of Development Protocol for Lab
9. the development & stability scale batch manufacturing of Empag-M Tablets (12.5mg + 1000mg).
testing of trial batches.

The master formulation and manufacturing method mentioned in
development protocol is same as that of reference product.
Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Record and
10. record of three stability batches. Batch Packaging Record of the following 03 Batches:
BATCH NO BATCH SIZE MFG DATE
18SB-103-01 1500 Tablets 04-2018
18SB-104-02 1500 Tablets 04-2018
18SB-105-03 1500 Tablets 04-2018
Record of remaining quantities The firm has attached Record of remaining quantities of stability
11. of stability batches. batches
QA / QC DATA
Record of Digital data logger for The firm has submitted photocopies of digital printouts of graphical
12. temperature and humidity chart for Real Time and Accelerated Conditions starting from 01-03-
monitoring of stability chambers 2018 to 31-10-2018.
Method used for analysis of API For Empagliflozin:
13. along with COA. The firm has submitted photocopy of raw material specifications, raw
material testing procedures and report for Empagliflozin.
For Metformin HCl:
The firm has submitted photocopy of raw material specifications, raw
material testing procedures and report for Metformin HCl.
Method used for analysis of FPP The firm has submitted photocopy of Finished Product Testing
14. & complete record of testing of Procedure (QC-FPNS-135 issued on 10-04-2018) for Empag M
stability batches (i.e. Tablets (12.5mg + 1000mg) along with Stability Study Report of
chromatograms, lab reports, raw stability batches.
data sheets etc.)
Reports of stability studies of For Empagliflozin:
15. API from manufacturer. The firm has submitted photocopy of Empagliflozin 06 Months
Accelerated (40oC+2 oC, RH 75+5%) Data of 03 Batches of from M/s
Ruyuan HEC Pharm Co., Ltd. China.
For Metformin HCl:
Metformin HCl 06 Months Accelerated (40oC+2 oC, RH 75+5%) and
72Months Real Time Stability Study (30oC+2 oC, RH 65+5%) of
Metformin HCl from M/s Wanbury Limited. India.
16. Analysis reports for excipients The firm has submitted photocopies of its own Analytical reports for
used. all excipients used in product development of Empag-M Tablets.
Drug-excipients compatibility The firm has stated that the composition of developed product is
17. studies. similar to the innovator‘s product formulation, no ingredient which
could have adverse effects over product‘s in-vivo performance is used
during product development therefor, it is presumed that used inactive
ingredients are compatible with the active (Empagliflozin+ Metformin
HCl) & also with each other and this is ensured by satisfactory results
from formal stability studies.
Record of comparative Firm has submitted F2 factor protocol (QC/PRO/CD/21) & reports
18. dissolution data. dated 03-12-2018. The details of reference product & Sample product
are as follows:
feature Reference product Product of M/S
Genix Pharma
Brand name Synjardy Tablet Empag-M Tablets

5mg/1000mg 5mg +1000mg
Batch No 605012 18SB-097-01
Expiry Date 12-2020 04-2020
Comparative dissolution studies have been performed in following
mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
In pH 0.1 N HCl buffer similarity factory is 87.083
In pH 4.5 Acetate buffer similarity factory is 84.201
In pH 6.8 Phosphate buffer similarity factory is 83.539
Compliance Record of HPLC Firm has submitted audit trail reports of stability studies of applied
19. software 21CFR & audit trail formulation
Remarks of Evaluator :
Sr.# Deficiencies Justification
1. You are acquiring Metformin Hcl from M/s M/s Wanbury, Head office located in
Wanbury, a pharmaceutical unit located in Maharashtra state while manufacturing unit
Maharashtra state of India as per commercial located in Andhra-Pardesh. This address is also
invoice, but submitted GMP certificate is of another mentioned on commercial invoice, COA and
site of same manufacturer located in Andhra- GMP.
Pardesh. Submit GMP certificate of desired site. Reference attached (Annexure point no. 1)
2. You have procured four lots of Metformin Hcl as per The batch number MT00600118 is used.
invoice; also submit the record about which lot is COAs and BMRs are attached for reference.
used in the manufacturing of trial batches. Annexure point No.2
3. COA for one lot of Metformin Hcl is submitted, but Genix Pharma is also manufacturing other
you have procured four lots, as per submitted combination products like Metformin Hcl and
commercial invoice, clarify/justify Sitagliptin Phosphate Tablets Range. That‘s
why Metformin Hcl is used from commercial
material.
4. How would you have come to know about batch The clarification letter from supplier with
number of Empagliflozin, one of the APIs of applied purchase invoice is attached as reference
drug product, as it is not mentioned on commercial (Annexure Point no 4)
invoice. Clarify/Justify.
5. What analytical method you are using for test/ The in-house validated method is used for
Analysis of applied drug product either in-house or analysis of finished product
supplier. (Annexure Point no 5)
6. Evidence of procurement of reference product Purchase invoice attached
Synjardy XR? (Annexure Point no 6)
7. Submit Raw data sheets for dissolution and assay Complete dissolution and assay testing along
testing along with chromatograms at every time with chromatograms are attached in file
points because raw data sheet submit separately (Annexure Point no 7)
which are difficult to understand.
8. In dissolution testing, Empagliflozin is quantified by Empagliflozin cannot be detectable due to its
HPLC & Metformin Hcl is quantified by UV lowest concentration with respect to metformin
method as per your FPP Specification. Justify. Hcl. That‘s why dissolution is conducted on
HPLC while Metformin Hcl can be detected
without any interference.
Dissolution of Metformin Hcl extended release
tablets are also given in USP by Spectroscopy
method.
9. Submit spectrums for dissolution testing of UV data of Metformin Hcl is attached in
metformin Hcl, if you have quantified it on UV. separate file
(Annexure Point no 7)
10. In dissolution testing, Empagliflozin is quantified by The dissolution of Empagliflozin was conducted

HPLC & Metformin Hcl is quantified by UV as per assay method that‘s why tablets
Spectrophotometric Method as per your FPP contained to APIs showing its absorbance
Specification, but all chromatog-Uiorams for Metformin Hcl and Empagliflozin.
dissolution testing shows peaks for both APIs.
Clarify/Justify.
11. Date acquired 29th of June 2018 on chromatograms Audit Trial reports of content uniformity are
for run of sample of content uniformity test at initial attached
studies of trial no 18SB-112-01CU03 of applied (Annexure Point no 11)
drug product is not verifiable from the submitted
audit trial reports some others chromatograms are
not verifiable form submitted audit trial reports.
Clarify/Justify
12. Details of equipment used for applying layer of (Attached in Annexure Point no 12)
Empagliflozin over Metformin Hcl Extended release
core, is required to be submitted
Decision: Deferred for clarification regarding compensation of manufacturing loss during coating of
API(Empagliflozin) over extended release core(Metformin hydrochloride) as there is no any overage
mentioned in master formulation to compensate for manufacturing/process loss of API during coating.
Name and address of manufacturer / M/s Werrick pharmaceuticals, 216-217, I-10/3, Industrial Area,
Brand Name +Dosage Form + Strength Betanorm Plus Tablets 5/80mg
Nebivolol as hydrochloride…5mg
Valsratan……….80 mg
Diary No. Date of R& I & fee Dy.No. dated 09-03-2017 Rs.20, 000/- for Form 5
Dated 09-03- 2017
Dy. No_________ dated 03-04-2017 differential fee of
Rs.30,000/- for Form 5D Dated 03-04- 2017
Pharmacological Group B-adrenergic Receptor blocking Agent,
946. Angiotensin II Receptor Blocker

Pack size & Demanded Price 30‘s ; As per SRO

GMP status GMP Inspection conducted on 02-02-2017 with conclusive
compliance.
Drug Betanorm Plus Tablets 5/80mg
M/s Werrick pharmaceuticals, 216-217, I-10/3, Industrial Area,
Name of Manufacturer Islamabad.
Manufacturer of API Nebivolol as hydrochloride: M/s Cadila pharmaceuticals
Limited.
Valsartan: M/s Zhejiang Tianyu Pharmaceutical Co., China.
API Lot No. Nebivolol as hydrochloride:
Lot #: 17NV016
Valsartan:
Lot #: 10240-170702
Description of Pack Alu /PVC Blister Pack in Unit carton

Real Time: 30°C ± 2°C / 65% ± 5%RH

Real Time: 9 Months
Frequency Real Time: 0,3, 6,9,12,18 & 24 (months)
Accelerated: 0,3 & 6 (months)
03
No. of Batches
Date of Submission Dy No. 39212: 28/11/2018
Sr.
No.
1 COA of API. Firm has submitted the following:
Nebivolol as hydrochloride:
Copy of COA:
Batch #: 17NV016
Manufacturer: M/s Cadila Pharmaceuticals Ltd, India.
Valsartan:
Copy of COA:
Batch #:10240-170702)
Manufacturer: M/s Zhejiang Tianyu Pharmaceuticals
Co, Ltd, China.
2 Approval of API by regulatory authority of Firm has submitted the following:
country of origin or GMP certificate of API Nebivolol as hydrochloride:
manufacturer issued by regulatory authority Copy of GMP certificate:
of country of origin. Certificate No.180686
Issued by: India Food & Drugs Control Administration,
India.
Validity: until 20/12/2018
Valsartan:Copy of GMP certificate:
Certificate No. Zj20130111
Issued by: China Food & Drugs Administration, china.
Validity: until 09/12/2018
3 Protocols followed for conduction of stability
study and details of tests. Yes
4 Data of 03 batches will be supported by

Yes
sheets etc.
5 Documents confirming import of API etc. Firm has submitted the following:
Nebivolol as hydrochloride:
Copy of commercial invoice:
Dated: 31-07-2017
Valsartan:
Dated: 17-08-2017 attested by ADC, DRAP,Islamabad
6 All provided documents will be attested
authenticity of data /documents.

7 Commitment to continue real time stability
Yes
8 Commitment to follow Drug Specification Yes
Rules, 1978.
Data for EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided the following documents in conjunction with the checklist approved by the Registration Board in
its 278th Meeting:
Date of submission: 28-11-2018 vide diary No. 28-11-18.
1 Reference of last onsite panel Firm has referred to onsite inspection report of their product ―Cell-
inspection for instant dosage form Tab 400mg (Sofosbuvir) Tablets‖, which was presented Initially in
conducted during last two 256th subsequently in 269th &finally in 276th meeting of
years. Registration board.
Registration Board decided to approve registration of above stated
drug product of M/s. Werrick
●The firm has 21CFR compliant HPLC software.
●The firm has audit trail reports available.
2 Documents for the procurement Firm has submitted the following:

of API with approval from DRAP For Nebivolol hydrochloride:
(in case of import). Copy of commercial invoice:
Dated: 31st of July, 2017.
Attested on: 31st of August, 2017.
Attested By: ADC, DRAP Islamabad.
Quantity of API: 5kgs Nebivolol hydrochloride.
Batch #: 17NV016
For Valsartan:
Dated: 11th of August 2017.
Attested on: 06th of August, 2017.
Attested By: ADC, DRAP Islamabad.
Quantity of API: 500kgs.
Batch #: 10240-170701/10240-170702.
3 Documents for the procurement The firm has submitted copies of COA for following
of reference standard and working standard & impurity Standards:
impurity standards. For working standard:
Nebivolol hydrochloride : 100.5 %
Valsartan: 99.7%
For Impurity standard:
Valsartan Related compound A: 99.9%
Valsartan Related compound B: 98.3 %
Valsartan Related compound C: 99 %
4 Approval of API/ DML/GMP The firm has submitted copy of GMP certificates
certificate of API manufacturer declaring following information:
issued by regulatory authority of For Nebivolol as hydrochloride:
country of origin. Certificate No.180686
Issued to: M/s Cadila Pharmaceutical Ltd, 294, G.I.D.C Estate,
Ankleshwar-393 002, District- Bharuch. India.
Issued by: Food & Drug Control Administration, Gujarat State, India.
For Valsartan:
Certificate No. ZJ 20130111
Issued to: M/s Zhejiang Tianyu Pharmaceutical Co., Ltd, China.

Issued by: State Food & Drug Administration, China.
5 Mechanism for Vendor pre- The firm has submitted copy of SOP for Evaluation of Vendors.
qualification
6 Certificate of analysis of the API, Applicant has submitted following COAs:
reference standards and impurity APIs:
standards For Nebivolol hydrochloride:
Copy of COA of API
Batch # 17NV016
From: M/s Cadila Pharmaceutical Ltd, India.
For Valsartan:
Copy of COA of API
Batch # 10240-170702
From: M/s Zhejiang Tianyu Pharmaceutical Co., Ltd, China.
For Reference Standards:
Copy of COA of Nebivolol hydrochloride
Copy of COA of Valsartan
For Working Standards:
Copy of COA for Valsartan impurity Standards A, B & C
7 Documents for the procurement The firm has submitted photocopy of Commercial
of excipients used in product invoices/COAs of all the excipients used in the
development? formulation of applied product.
Commercial invoice dated 01-11-17 for Microcrystalline cellulose.
200.
Commercial invoice dated 17-11-16 for HPMC.
Commercial invoice dated 14-01-17 for Talcum.
Commercial invoice dated 19-04-17 for Sodium Starch Glycolate.
Commercial invoice dated 03-11-16 for Magnesium Stearate.
Commercial invoice dated 25-09-17 for Titanium Dioxide.
Commercial invoice dated 25-09-17 for Polysorbate tween.
Commercial invoice dated 24-07-17 for Color Red # 40.
8 List of qualified staff involved in The firm has submitted List of qualified staff involved in product
product development with development.
Production Data
9 Authorized Protocols/SOP for the The firm has submitted photocopy of ―Work Instructions‖ for the
development & stability testing of Development of Betanorm Plus Tablets 5/80mg‖.
trial batches.
10 Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Records
record of three stability batches. of following 03 Batches:
Trial # 01 1500 tablets Nov-17
Trial # 02 1500 tablets Nov-17
Trial # 03 1500 tablets Dec-17

11 Record of remaining quantities of Trial Total no. of Tablets Remaining
stability batches. No Tablets used for Quantities
For stability testing of tablets
testing
Trial # 1246 Tab
01 (41 packs * 210 1036
(7packs (34 packs *
30‘s)
* 30‘s) 30‘s)
Trial # 1226 Tab
210 1016
02 (40 packs *
(7packs (33 packs *
30‘s)
* 30‘s) 30‘s)
Trial # 1232 Tab
210 1022
03 (41 packs *
(7packs (34 packs *
30‘s)
* 30‘s) 30‘s)
QA / QC DATA
12 Record of Digital data logger for Firm has submitted photocopies of data logger record temperature &
temperature and humidity humidity for chambers used in Real Time & Accelerated stability
monitoring of stability chambers studies of applied product from 01-12-2017 to 31-08- 2018.
(real time and accelerated).
13 Method used for analysis of API The firm has submitted photocopies of following:
along with COA. Raw Material Test/Analysis Procedures & Raw Material
Specifications Of Nebivolol hydrochloride (In-house) and Valsartan
(USP).
COAs for Nebivolol hydrochloride & Valsartan
(Supplier/Manufacturer).
14 Method used for analysis of FPP The firm has submitted photocopies of following:
& complete record of testing of FPP Test/Analysis Method & FPP Specifications (In-house) for
stability batches (i.e. Betanorm Plus 5/80mg tablet.
chromatograms, lab reports, raw Firm has submitted method validation studies on following
data sheets etc.) parameters:
Specificity
Linearity
Accuracy
Robustness
Precision
15 Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated and 18
from manufacturer. Months Real Time Stability Study Data of 03 Batches of Nebivolol
HCl from M/s Cadila Pharmaceutical Ltd, India according to zone
IVA conditions.
The firm has submitted photocopy of 06 Months Accelerated and 36
Months Real Time Stability Study Data of 03 Batches of Valsartan
from M/s zhejiang Tianyu Pharmaceutical Co., Ltd, China according
16 Analysis reports for excipients The firm has submitted copy of Analytical reports of
used. excipients used.
17 Drug-excipients compatibility Applicant is referring to handbook of Pharmaceutical excipients &
studies. innovator Product (Byvalsont tablet) & stability studies as an
evidence of Drug-excipients compatibility.
18 Record of comparative The firm has performed comparative dissolution studies in three
dissolution data. media including pH 1.2, pH 4.5 and pH 6.8 buffers with Byvalson
Tablets 5/80mg distributed by M/S. Allergan USA with Lot
No.W00551. The firm‗s product results are comparable to that of the
competitor product.

19 Compliance Record of HPLC Audit trail on testing reports of Nebivolol HCl & Valsartan from 27-
software 21CFR & audit trail 11-2017 to 13-09-2018 was submitted by the firm.
Remarks Of Evaluator:
Sr. Query Response by the form
No
.
1 Submit valid GMP Certificates of When we submitted Registration file , GMP certificate of the
Both API Manufacturers, as these are manufacturer were valid then. Now we are again submitting
not valid now. valid GMP certificates.
2 Submit documents for the documents for the procurement of excipients; Color Red # 40
procurement of excipients Color Red & HPMC; used in manufacturing of trial batches are
# 40 & HPMC; used in manufacturing submitted now.
of trial batches.
3 Sodium starch glycolate is not an Sodium Starch glycolate is widely used in oral
excipient of innovator & you have not pharmaceuticals as a disintegrant in capsule & tablet
performed drug excipient formulations. It is commonly used in tablet prepared by either
compatibilities studies, How would direct compression or wet granulation process.
you justify the compatibility of this Although the effectiveness of many disintegrants is effected
excipient with drug. by the presence of hydrophobic excipients such as lubricants,
the disintegrant efficiency of sodium stach glycolate is
unimpaired.
Ref: Hand book of Pharmaceutical Excipients, sixth edition.
Decision: Registration Board decided to approve registration of ―Betanorm Plus Tablets 5/80mg
(Nebivolol as hydrochloride & Valsartan) by M/s Werrick pharmaceuticals, Islamabad. Manufacturer
will place first three production batches of the product on long term stability studies throughout proposed

No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Availability / Local
Dosage Form + Date, Fee Availability
Strength), Composition, (including
Finished Product Demanded Price / Report Date &
Specification Pack size Remarks
947. M/s Saffron Pharmaceuticals SAFPAVIR TABLET Duplicate Dossier. Approved in US-FDA.
(Pvt.) LTD, 19 Km Sheikhupura Each film coated tablet Form-5D The firm was granted
Road, Faisalabad. contains: Dated.28-10-2016 GMP certificate based
Sofosbuvir…400 mg Rs.50,000/- on inspection
Velpatasvir…100 mg (Photocopy) conducted on dated 3rd
Rs. 34500/28‘s of October, 2018.
Drug SAFPAVIR Tablet 400mg/100mg.
Name of Manufacturer M/s Saffron Pharmaceuticals (Pvt.) LTD, 19 Km Sheikhupura Road,
Faisalabad.
Manufacturer of API Sofosbuvir: M/s Ruyuan HEC Pharm Co Ltd. China.
Velpatasvir: M/s Ruyuan HEC Pharm Co Ltd. China.
API Lot No. Sofosbuvir: YAK-RD201608202
Velpatasvir: VEPII-20162001
Description of Pack
Alu/Alu blister packed in unit cartoon (28‘s)

Frequency Accelerated: 0, 1, 3,6 (month)
Real Time: 0, 3,6 (month)
Batch No. T-002 T-003 T-004
Batch Size 1500 1500 1500

Date of Initiation 07-2017 07-2017 09.2017
No. of Batches 03
Date of Submission 22-02-2019 (Dy. No 22-02-19)
No.
1. COA of API Firm has submitted copy of GMP certificate
of Sofosbuvir
of M/s Ruyuan HEC Pharm Co Ltd. China,
Issued by Shaoguan Food and Drug
Administration China dated 19.12.2018
Firm has submitted copy of GMP Certificate

of Velpatasvir
of M/s Ruyuan HEC Pharm Co Ltd. Issued
by Shaoguan Food and Drug Administration
China dated 19-12-2018.
2. Approval of API by regulatory authority of country of origin Firm has submitted following:
or GMP certificate of API manufacturer issued by Copy of GMP certificate for Sofosbuvir &
regulatory authority of country of origin. Velpatasvir copovidone dispersion.
Issued To: M/s Ruyuan HEC Pharm Co Ltd.
China.
Issued By: Shaoguan Food and Drug
Administration China.
Issued On: 19.12.2018.
Valid up till: 18-12-2019
Yes
details of tests.
4. Data of 03 batches will be supported by attested respective
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir:
Firm has submitted copy of ADC attested
invoice confirming import of 5.0 Kg from
The invoice was cleared on 15.01.2017.
Velpatasvir
Firm has submitted copy of ADC attested
invoice confirming import of 1.80 Kg M/s
Ruyuan HEC Pharm Co Ltd. China .The
invoice was cleared on 06.04.2017.
6. All provided documents will be attested (name, sign and Yes

Yes
Data for exemption from on-site investigation of submitted stability data.
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product Saffaldi
inspection for instant dosage form Tablet 400mg (Sofosbuvir), which was conducted on 8th January, 2018
conducted during last two years. and was presented in 279th meeting of Registration Board held on 28th of
February -2nd of March, 2018.
ii. Adequate monitoring and control are available for stability
chambers. Data Loggers are also placed in stability
chambers for monitoring.
2. Documents for the procurement of Applicant has submitted ADC attested invoice stating following
API with approval from DRAP (in information on it:
case of import). For Sofosbuvir:
Manufacturer of API: M/s Ruyuan HEC Pharm Co Ltd. China.
Exporter of API: M/s. WIS Pharmatech, China.
Quantity of API: 5Kg.
Cleared on/Attested on: 15-01-2017.
For Velpatasvir Co-Povidone solid dispersion:
Manufacturer of API: M/s Ruyuan HEC Pharm Co Ltd. China.
Exporter of API: M/s. WIS Pharmatech, China.
Quantity of API: 5Kg.
Cleared on/Attested on: 06-04-2017.
3. Documents for the procurement of
standards.
4. Approval of API/ DML/GMP Firm has submitted following:
certificate of API manufacturer Copy of GMP certificate for Sofosbuvir & Velpatasvir Co-Povidone
issued by regulatory authority of Dispersion.
country of origin. Issued To: M/s Ruyuan HEC Pharm Co Ltd. China.
Issued By: Shaoguan Food and Drug Administration China.
Issued On: 19.12.2018.
5. Mechanism for Vendor pre- Firm has submitted copy of SOPs for vendor qualification.
qualification
6. Certificate of analysis of the API, Firm has submitted following documents:
reference standards and impurity COA of both APIs from M/s. Ruyuan HEC.
standards. Qualification report reference standard.
Qualification report of Sofosbuvir impurity Standards A, B, C, D, F.
7. Documents for the procurement of Firm has submitted documents for procurement of excipients.
development?
8. List of qualified staff involved in Firm has provided list of technical staff of product development with
product development with relevant relevant experience.
experience.

Production Data
9. Authorized Protocols/SOP for the Firm has submitted authorized general protocols/SOPs for the
development & stability testing of development & testing of trial batches.
trial batches.
10. Complete batch manufacturing Firm has provided Batch Manufacturing Record for all the three batches.
record of three stability batches.
11. Record of remaining quantities of Firm has provided following remaining quantities for each batch
stability batches. T-002: 252 Tablets
T-003: 430 Tablets
T-004: 430 Tablets
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of Digital data logger for temperature and
temperature and humidity humidity monitoring of stability chambers.
13. Method used for analysis of API Firm has submitted COA and method of analysis of API.
along with COA.
14. Method used for analysis of FPP Firm has submitted method of analysis of FPP and complete record of
& complete record of testing of testing of stability batches along with chromatograms
stability batches (i.e.
data sheets etc.)
15. Reports of stability studies of Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH) stability
API from manufacturer. studies & long term (30°C ± 2°C & 65±5%RH) stability studies reports
of three batches.
16. Analysis reports for excipients Firm has submitted analysis reports for all excipients used.
used.
17. Drug-excipients compatibility Firm has submitted drug excipient compatibility studies by mixing both
studies. API with all excipients and then determination of % content by HPLC.
18. Record of comparative Firm has submitted data of comparative dissolution profile at pH 1.2, 4.5
dissolution data. and 6.8.and calculated values of f2 which were within accepted range
19. Compliance Record of HPLC Firm has submitted audit trial reports for HPLC analysis for all the three
software 21CFR & audit trail batches.
Evaluation by PEC:
S.# Query Response by the firm
1. Submit documents for the procurement of Chromatographic purity by HPLC (%age Area)
reference standard and impurity standard as in documents are attached herewith. Therefore no
this section your have submitted commercial impurity standard required in such case.
invoices for the import of API.
2. COAs of reference standard and impurity COA of reference standard submitted
standards have not been submitted.
3. Submit record of digital datat logger of Documents are submitted.
stability chamber for accelerated stability
studies.
4. Submit procedure for drug-excipient
Required stability data according to Zone IV-A
compatibilities studies. manufacturer has not provided the data due to current
Crisis between both the countries; we are
continuously having follow up regarding this matter.
5. Evidence of procurement of reference drug Applicant has submitted something else
procedure for CDP.

6. For six month stability studies of Trial T003 Single peak are visible, Documents are attached
all chromatograms for Velpatasvir have two herewith
peaks in them. Justify / clarify.
7. For 3rd month stability studies of trial T002 PDA detector used in that case of two peaks.
peaks on chromatograms for both APIs are not
visible. Clarify / justify.
Decision: Registration Board decided to approve registration of ―SAFPAVIR Tablets 400mg/100mg
(Sofobuvir & Velpatasvir) by M/s Saffron Pharmaceuticals (Pvt.) LTD, Faisalabad. Manufacturer will
place first three production batches of the product on long term stability studies throughout proposed shelf
948. Name and address of manufacturer / M/s Wilson‘s Pharmaceuticals, 387-388, Industrial Area,
Brand Name +Dosage Form + Strength CO-O Tablets 2.5mg

Apixaban……..2.5mg
Diary No. Date of R& I & fee Dy No. ; 06-12-2018: 20,000/- ; 07-12-18
Pharmacological Group Factor XA Inhibitor
Type of Form Form-5
Regulatory Authorities. Eliquis
Me-too status Apixa Tablets
CCL Pharmaceuticals
compliance.
Drug CO-O Tablets 2.5mg
Name of Manufacturer M/s Wilson‘s Pharmaceuticals, 387-388, Industrial Area, Islamabad.
Manufacturer of API M/s Glenmark Pharmaceuticals, Ltd, GIDC Industrial Estate, Ankleshwar-
393002, Gujarat State, India
API Lot No. Lot #: 801704823 , Quantity; 100g
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (Months) Real Time: 6 (Months)
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. Trial #01/Trial 01A Trial #02 Trial #03
No. of Batches 03
Date of Submission (06-12-2018)
1. COA of API. Copy of COA (batch #801704823) from M/s Glenmark
th
Pharmaceuticals, Ltd, Plot no 3109, GIDC Industrial Estate,
Ankleshwar- 393002, and Gujarat State, India is submitted.
2. Approval of API by regulatory Copy of GMP certificate (certificate No. G/25/1629) issued by
authority of country of origin or Food & Drugs Control Administration, India. It is valid until
GMP certificate of API 30-04-2020.
manufacturer issued by regulatory
4. Data of 03 batches will be supported Yes
by attested respective documents
like chromatograms, laboratory
5. Documents confirming import of The firm has submitted copy of commercial invoice for 100gm
API etc. dated 29-09-2017 attested by ADC, DRAP, Islamabad
6. All provided documents will be Yes
documents.
7. Commitment to continue real time Yes
stability study till assigned shelf life
of the product.
8. Commitment to follow Drug Yes
-The firm has submitted 6months Accelerated and Real Time Stability Data for 03 Batches.
following documents as per checklist approved by the Registration Board in its 278 th Meeting:
Date of submission: 27-02-2018 vide diary No. 8825.
inspection for instant dosage form ―Saferon (Sofosbuvir 400mg) Tablets‖, which was conducted on
conducted during last two years. 19th April, 2017 and was presented in 278th meeting of
Registration board. Registration Board decided to approve
registration of Saferon (Sofosbuvir 400mg) Tablets‖ by M/s.
Wilson Pharmaceuticals Islamabad. According to the report
 The firm possesses stability chambers with digital data
loggers.
2. Documents for the procurement of The firm has submitted copy of commercial invoice dated 29-09-
API with approval from DRAP (in 2017 attested by ADC, DRAP, Islamabad.
case of import).
3. Documents for the procurement of The firm has submitted copy of invoice declaring following
reference standard and impurity information:
standards. For Working Standard & Impurities A, B, C, D, E.
Invoice Number : 2006007417
Dated: 05-12-2017
4. Approval of API/ DML/GMP The firm has submitted copy of GMP certificate declaring following
certificate of API manufacturer issued information:
by regulatory authority of country of Certificate No. G/25/1629
origin. Issued to: M/s Glenmark Pharmaceuticals, Ltd, Plot No. 3109, GIDC
Industrial Estate, Ankleshwar- 393002, Gujarat State, India
Issued by: Food & Drugs Control Administration, Gujrat state India.
qualification
reference standards and impurity For API:
standards  Copy of COA (batch #801704823) from M/s Glenmark
Pharmaceuticals, Ltd, Plot No. 3109, GIDC Industrial Estate,
Ankleshwar- 393002, Gujarat State, India is submitted.
For reference/working standard:
 Copy of COA of working standard for is submitted.
Working standard Number: 18801-01.
For Impurities:
 Copy of COA of impurity Standards A, B, C, D & E has been
submitted.
7. Documents for the procurement of The firm has submitted photocopy of Commercial invoices/COAs of
excipients used in product all the excipients used in the formulation of applied product.
development?
8. List of qualified staff involved in The firm has submitted List of qualified staff comprising of 11
product development with relevant members involved in R&D department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of ―Protocols/SOP for the
development & stability testing of Development of CO-O Tablets 2.5 mg‖.
trial batches.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing Records
of three stability batches. of following 03 Batches:
Trial # 01 1500 tablets 03-2018
Trial # 02 1500 tablets 03-2018
Trial # 03 1500 tablets 03-2018
Trial No CO-O Tablets 2.5mg
Remaining Quantity
Accelerated Long Term
Trial # 01 109 tablets 205 tablets
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for chambers
temperature and humidity monitoring used in Real Time & Accelerated stability studies of applied product
of stability chambers (real time and from 01-03-2018 to 30-09-2018.
accelerated).
13. Method used for analysis of API The firm has submitted photocopies of following:
along with COA.  Raw Material Test/Analysis Procedures & Raw Material
Specifications (In-house).
 COAs for Apixaban (Supplier/Manufacturer).
14. Method used for analysis of FPP & The firm has submitted photocopies of following:
complete record of testing of stability  FPP Test/Analysis Method & FPP Specifications (In-house)
batches (i.e. chromatograms, lab for CO-O Tablets 2.5 mg.
15. Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated and 36
from manufacturer. Months Real Time Stability Study Data of 03 Batches of Apixaban
from M/s Glenmark Pharmaceuticals, Ltd, India.
16. Analysis reports for excipients used. The firm has submitted copy of Analytical reports of excipients used.
17. Drug-excipients compatibility Excipients of applied drug product are similar to that of innovator
studies. product (Eliquis).
18. Record of comparative dissolution The firm has submitted comparative dissolution studies in three
data. media including (0.1 N HCl) pH 1.2, (Acetate Buffer) pH 4.5 and
(Sodium Phosphate Buffer) pH 6.8 buffers with Eliquis Tablets 5mg
manufactured by Pfizer Ortakoy with Batch No.171731108.
19. Compliance Record of HPLC Firm has submitted audit trail reports of stability Studies of applied
software 21CFR & audit trail reports formulation.
on product testing.
S. NO. Query Response by the firm.
1 In procedure for dissolution Submitted spectra of dissolution test show absorbance by peak
testing it is mentioned that pick calculation. A spectrophotometer records the degree of
measure the other absorbance on absorption by a sample at different wavelength and the resulting
UV spectrometer at 277+5nm. plot of absorbance (A) versus (ƛ) is known as a spectrum. By
Clarify / justify peak pick calculation spectrophotometer give absorbance at ƛ
max (wavelength at which there is a maximum absorbance).
That is why there is ± difference from actual wavelength is
observed.
Now spectra of next two intervals (9th month & 12 Month) with
point pick calculation of absorbance at single & fix wavelength
of Apixaban are attached. All result of dissolution test are within
limit.
2 Result of dissolution testing is On certificate of analysis of working standard, assay limit is 98-
calculated without considering the 102% while potency of working standard is 99.1% as per
potency of standard as the COA,that complies with assay limit. If we are getting such assay
potency of working standard is result of working standard like 99% or 101% we can consider it
99%. Clarify / justify analytical deviation and can round it to 100% for routine
application or can use potency as 100%.
If assay results of working standard are not within limit then it is
very necessary to confirm the things with high degree of
investigation.
3 Why the content uniformity test is Content uniformity test had been performed but was not
not performed by the firm, Clarify submitted as it is not a stability indicating parameter. Content
/ justify. uniformity data, attached as Now.
4 Submit how much quantity of Working standard & all impurities are supplied by supplier, free
working standards and impurities of cost and on our demand non commercial invoice & COAs of
are imported airway bill/any other working standard and all impurities is provided by supplier,
evidence for the import of the attached now.
same.
5 Submit invoice for purchase of We are submitting it Now.
SLS and lactose (Tablettose)
6 Submit evidence of purchase of Firm has submitted photocopy of pictures of outer packing of
reference product/innovator reference pro reference product/innovator product.
product.
7 Chromatograms of method We are submitting it Now.
validation studies are verifiable
from submitted audit trail data.
Justify / clarify
Decision: Registration Board deferred the case & advised the firm to mention that one wavelength (ƛ max
wavelength at which there is a maximum absorbance) at which dissolution testing has to be performed &
submit the results of dissolution testing for next time interval by taking reading on that wavelength(ƛ max).
949. Name and address of manufacturer / M/s Wilson‘s Pharmaceuticals, 387-388, Industrial Area,
Brand Name +Dosage Form + Strength CO-O Tablets 5mg
Apixaban……..5mg
Diary No. Date of R& I & fee Dy No. ; 06-12-2018: 20,000/- ; 07-12-18
Pharmacological Group Factor XA Inhibitor
Type of Form Form-5
Regulatory Authorities. Eliquis
Me-too status Apixa Tablets
CCL Pharmaceuticals
compliance.
Drug CO-O Tablets 5mg
Name of Manufacturer M/s Wilson‘s Pharmaceuticals, 387-388, Industrial Area, Islamabad.
Manufacturer of API M/s Glenmark Pharmaceuticals, Ltd, GIDC Industrial Estate, Ankleshwar-
393002, Gujarat State, India
API Lot No. Lot #: 801704823 , Quantity; 100g
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 0,3,6,9,12,18,24 (Months)
Batch No. Trial #01 Trial #02 Trial #03
No. of Batches 03
Date of Submission (06-12-2018)
No.
1. COA of API. Copy of COA (batch #801704823) from M/s Glenmark
Pharmaceuticals, Ltd, Plot no 3109, GIDC Industrial Estate,
2. Approval of API by regulatory authority Copy of GMP certificate (certificate No. G/25/1629) issued
of country of origin or GMP certificate of by Food & Drugs Control Administration, India. It is valid
API manufacturer issued by regulatory until 30-04-2020.

sheets etc.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice dated 29-
09-2017 attested by ADC, DRAP, Islamabad
7. Commitment to continue real time Yes
stability study till assigned shelf life of the
product.
Rules, 1978.
● The firm has submitted 6months Accelerated and Real Time Stability Data for 03 Batches.
Meeting:
Date of submission: 27-02-2018 vide diary no.
inspection for instant dosage form ―Saferon (Sofosbuvir 400mg) Tablets‖, which was conducted on
conducted during last two years. 19th April, 2017 and was presented in 278th meeting of
Registration board. Registration Board decided to approve
registration of Saferon (Sofosbuvir 400mg) Tablets‖ by M/s.
Wilson Pharmaceuticals Islamabad. According to the report
The firm possesses stability chambers with digital data
loggers.
2. Documents for the procurement of Copy of commercial invoice dated 19th of September 2017 declaring
API with approval from DRAP (in 100g quantity of API has been submitted which is attested by ADC,
case of import). DRAP Islamabad.
3. Documents for the procurement of The firm has submitted copy of commercial invoice dated 29-09-
reference standard and impurity 2017 attested by ADC, DRAP, Islamabad.
standards. The firm has submitted copy of invoice declaring following
information:
For Working Standard & Impurities A, B, C, D, E.
Invoice Number : 2006007417
Dated: 05-12-2017
4. Approval of API/ DML/GMP The firm has submitted copy of GMP certificate declaring
certificate of API manufacturer following information:
issued by regulatory authority of Certificate No. G/25/1629
country of origin. Issued to: M/s Glenmark Pharmaceuticals, Ltd, Plot no 3109,
GIDC Industrial Estate, Ankleshwar- 393002, Gujarat State, India
Issued by: Food & Drugs Control Administration, India.

qualification
reference standards and impurity For API:
standards  Copy of COA (batch #801704823) from M/s Glenmark
Pharmaceuticals, Ltd, Plot No. 3109, GIDC Industrial Estate,
For reference/working standard:
 Copy of COA of working standard for is submitted.
Working standard Number: 18801-01.
For Impurities:
Copy of COA of impurity Standards A, B, C, D & E has been
submitted.
7. Documents for the procurement of The firm has submitted photocopy of Commercial invoices/COAs of
excipients used in product all the excipients used in the formulation of applied product.
development?
8. List of qualified staff involved in The firm has submitted List of qualified staff comprising of 11
product development with relevant members involved in R&D department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of ―Protocols/SOP for the
development & stability testing of Development of CO-O Tablets 5 mg‖.
trial batches.
10. Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Records
record of three stability batches. of following 03 Batches:
Trial # 01 1500 tablets 03-2018
Trial # 02 1500 tablets 03-2018
Trial # 03 1500 tablets 03-2018
Trial No CO-O Tablets 5mg
Remaining Quantity
Accelerated Long Term
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for chambers
temperature and humidity used in Real Time & Accelerated stability studies of applied product
monitoring of stability chambers from 01-03-2018 to 30-09-2018.
(real time and accelerated).
13. Method used for analysis of API The firm has submitted photocopies of following:
along with COA.  Raw Material Test/Analysis Procedures & Raw Material
Specifications (In-house).
 COAs for Apixaban (Supplier/Manufacturer).
14. Method used for analysis of FPP & The firm has submitted photocopies of following:
complete record of testing of  FPP Test/Analysis Method & FPP Specifications (In-house)
stability batches (i.e. for CO-O Tablets 5 mg.
data sheets etc.)

15. Reports of stability studies of API The firm has submitted photocopy of 06 Months Accelerated and 36
from manufacturer. Months Real Time Stability Study Data of 03 Batches of Apixaban
from M/s Glenmark Pharmaceuticals, Ltd, India.
16. Analysis reports for excipients used. The firm has submitted copy of Analytical reports of excipients used.
17. Drug-excipients compatibility Excipients of applied drug product are similar to that of innovator
studies. product (Eliquis).
18. Record of comparative dissolution The firm has performed comparative dissolution studies in three
data. media including (0.1 N HCl) pH 1.2, (Acetate Buffer) pH 4.5 and
(Sodium Phosphate Buffer) pH 6.8 buffers with Eliquis Tablets
2.5mg manufactured by Pfizer Ortakoy with Batch No.171731002R..
19. Compliance Record of HPLC Firm has submitted audit trail reports of stability
software 21CFR & audit trail reports Studies of applied formulation.
on product testing.
S. Query Response by the firm.
NO.
1 In procedure for dissolution testing Submitted spectra of dissolution test show
it is mentioned that measure the absorbance by peak pick calculation. A
other absorbance on UV spectrophotometer records the degree of absorption
spectrometer at 277+5nm. Clarify / by a sample at different wavelength and the resulting
justify plot of absorbance (A) versus (ƛ) is known as a
spectrum. By peak pick calculation
spectrophotometer give absorbance at ƛ max
(wavelength at which there is a maximum
absorbance). That is why there is ± difference from
actual wavelength is observed.
Now spectra of next two intervals (9th month & 12
Month) with point pick calculation of absorbance at
single & fix wavelength of Apixaban are attached.
All result of dissolution test are within limit.
2 Result of dissolution testing is On certificate of analysis of working standard, assay
calculated without considering the limit is 98-102% while potency of working standard
potency of standard as the potency is 99.1% as per COA,that complies with assay limit.
of working standard is 99%. Clarify If we are getting such assay result of working
/ justify standard like 99% or 101% we can consider it
analytical deviation and can round it to 100% for
routine application or can use potency as 100%.
If assay results of working standard are not within
limit then it is very necessary to confirm the things
with high degree of investigation.
3 Why the content uniformity test is Content uniformity test had been performed but was
not performed by the firm, Clarify / not submitted as it is not a stability indicating
justify. parameter. Content uniformity data, attached as
Now.
4 Submit how much quantity of Working standard & all impurities are supplied by
working standards and impurities are supplier, free of cost and on our demand non
imported airway bill/any other commercial invoice & COAs of working standard
evidence for the import of the same. and all impurities is provided by supplier, attached
now.
5 Submit invoice for purchase of SLS We are submitting it Now.
and lactose (Tablettose)
6 Batch numbers of two trial batches ON each pack and strip of all three trials of both
of both strengths of applied drug strength of Apixabantablets, there is in houise
product are similar. How would you printing ofBrand Name with composition. Trial #
have distinguished them during Mfg. Date & expiry date and tablet color both
stability studies? strength is also different ( light yellow color 2.5mg
tablet & orange color 5mg tablet. Therefor all three
trials can be easily distinguished / identified during
stability study.
7 Chromatograms of method We are submitting it Now.
validation studies are verifiable from
submitted audit trail data. Justify /
clarify
Decision: Registration Board deferred the case & advised the firm to mention that one wavelength (ƛ max
wavelength at which there is a maximum absorbance) at which dissolution testing has to be performed &
submit the results of dissolution testing for next time interval by taking reading on that wavelength(ƛ max).
Evaluator PEC-VII
Case No. 01 Registration Applications for Local Manufacturing of (Human) Drugs.
a. New cases
950. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products Pvt Ltd, D-122, S.I.T.E,
Applicant Karachi
Brand Name +Dosage Form + Strength Quesanic 100 mg tablets
Quetiapine (as Fumarate)………………..100mg
Diary No. Date of R& I & fee Dyn# 11237, 7-8-2017, Rs, 20,000/-
Type of Form Form 5
Approval status of product in Reference Seroquel 100 mg film-coated tablets Approved in MHRA as
Regulatory Authorities film-coated
Me-too status Pequit tablets of M/s Medizan Pharmaceuticals
GMP status Copy of inspection conducted on 5-6-2018 and the report
concludes that firm overall ratings is GOOD.
Decision: Approved.
951. Name and address of Manufacturer / M/S Epharm Laboratories, A-40, Road No.1, S.I.T.E, Super
Applicant Highway, Industrial Area, North Karachi, Pakistan.
Brand Name+DosageForm+Strength Ponstapharm Forte Tablet 500mg
Mefenamic Acid….500mg
Diary No. Date of R&I & fee Dy.No.2707, 26-01-2017, Rs.20,000/-
Type of Form Form-5
Finished Product Specification B.P
Pack Size & Demanded Price 100‘s,200‘s,300‘S; As per SRO
Approval status of product in Reference Ponstan Forte Tablets by
Regulatory Authorities Chemidex Pharma Ltd UK
Me-too status DOLORAN-DS Tablet by EPLA Pharma
GMP status Last Inspection report conducted on 27-04-2017 and panel is of
the view to grant GMP certificate
Decision: Approved.
Applicant Highway, Industrial Area, ephagNorth Karachi, Pakistan.
Brand Name+DosageForm+Strength Ephagesic Tablets 450mg/35mg
Paracetamol….450mg
Orphenadrine citrate……35mg
Pharmacological Group Analgesic & Skeletal muscle relaxant
Type of Form Form-5
Pack Size & Demanded Price 50‘s,100‘s,500‘S; As per SRO
Approval status of product in Reference Norgesic by M/s iNova Pharmaceuticals, Australia (TGA)
Me-too status Acetor of Neomedix
GMP status Last Inspection report conducted on 27-04-2017 and panel is of
the view to grant GMP certificate
Decision: Approved.
Applicant Highway, Industrial Area, North Karachi, Pakistan.
Brand Name+DosageForm+Strength Ephamic -250mg Injection IM/IV
Tranexamic Acid…..250mg
Pharmacological Group Haemostatic/Fibrinolytic
Type of Form Form-5
Finished Product Specification B.P
Pack Size & Demanded Price 5mlx1‘s,5mlx5‘s,5mlx10‘s,5mlx100‘s; As per SRO
Approval status of product in Reference Tranexamic Acid-250mg/5ml Injection by Advacare Pharma
Regulatory Authorities USA
Me-too status BRINO-250mg injection by SAMI PHARMA.
GMP status Last Inspection report conducted on 27-04-2017 and report
concludes that the overall GMP was satisfactory.
Decision: Approved.
954. Name and address of manufacturer / M/s Cherwel Pharmaceuticals (Pvt) Ltd Plot # 20, phase 4,
Applicant Hattar industrial estate, KPK Pakistan
Brand Name +Dosage Form + Strength Esocure 20mg Capsule
Diary No. Date of R& I & fee Form-5 Dy.No 22895 dated 04-12-2017 Rs. 20,000/-
DATED 04-12-2017
Esomeprazole (enteric coated pellets)…20mg
Type of Form Form-5
Approval Status of Product in Esomeprazole 20 mg Capsule by Generics UK
Me-too Status Nexum Capsule by Getz Pharma
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
Decision: Approved.
955. Name and address of manufacturer / M/s Cherwel Pharmaceuticals (Pvt) Ltd Plot # 20, phase 4,
Applicant Hattar industrial estate, KPK Pakistan
Brand Name +Dosage Form + Strength Nafzole 40 mg
Diary No. Date of R& I & fee Form-5 Dy.No 22896 dated 04-12-2017 Rs. 20,000/-
Dated 04-12-2017
Omeprazole (as 22.5%w/w enteric coated pellets) …….. 40mg
Type of Form Form-5
Approval Status of Product in Approved by MHRA
Me-too Status Acizole Capsule 40mg by M/s Cirin Pharmaceuticals, (Reg#
034369)
Remarks of the Evaluator. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
Decision: Approved.
956. Name and address of manufacturer / M/s ICI Pharmaceuticals 5, West wharf, Karachi Contract
Applicant manufacture by Nabiqasim industry 17/24, Korangi industrial
area Karachi
Brand Name +Dosage Form + Strength Etipro IV infusion
Diary No. Date of R& I & fee Dy.No. Duplication 30-Aug-2016, 50,000/- (duplicate)
Composition Each Vial Contains:-
Omeprazole (as Sodium) ...……… 40 mg
Type of Form Form-5
Finished Product Specification As per innovator
Pack size & Demanded Price 1‘s / As Per SRO
Approval status of product in Reference Omeprazole IV of sandoz (TGA)
Me-too status Loprot of Nabiqasim
GMP status Last GMP Inspection dated 3-08-2017 with conclusive remarks
of acceptable cGMP compliance
Remarks of the Evaluator.  No USP or BP monograph is available for applied
formulation.
 ICI has 2 sections
 They are already manufacturing 6 products on contract
manufacturing bases.
Decision: Deferred whether application was submitted by M/s ICI or Wyeth.
957. Name and address of manufacturer / M/s Paramount Pharmaceuticals, 36, industrial area triangle
Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Clorten 4 mg tablets
Lornoxicam ….4mg
Type of Form Form 5
Finished product Specifications Manufacturer specs
Pack size & Demanded Price 1x10‘s / As per SRO
Approval status of product in Reference Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG, (Swiss
Regulatory Authorities Medic approved)
Me-too status Acabel 4mg Tablet by M/s Continental Pharma (Reg
No:061603)
GMP status Last inspection report 16 jan 2019, Firm is allowed to start the
manufacturing in the light of GMP guideline
Brand Name +Dosage Form + Strength Amval tablet 10/160
Amlodipine (as besylate)….. 10 mg

Valsartan…..160mg

Type of Form Form 5
Approval status of product in Reference EXFORGE of USFDA
Me-too status Amlodine Tablet 10/160mg of M/s Jupiter Pharma
Decision:Approved.
Valsartan…..80 mg
Type of Form Form 5
Me-too status Amlodine Tablet 5/80 mg of M/s Jupiter Pharma
Decision:Approved.
Valsartan…..160mg
Type of Form Form 5
Me-too status Amlodine Tablet 5/160 mg of M/s Jupiter Pharma
Decision:Approved.
Brand Name +Dosage Form + Strength Azolin 400mg tablets
Doxyphylline ….. 400 mg

Pharmacological Group Anti-Asthmatic
Type of Form Form 5
Approval status of product in Reference NA (In Italy)
Me-too status Doxfree of EG Pharma
Decision:Approved.
Brand Name +Dosage Form + Strength Azolin 8 mg tablets
Lornoxicam ….8mg
Type of Form Form 5
Finished product Specifications Manufacturer specs
Approval status of product in Reference Xefo 8 mg Filmtabletten by M/s Takeda Pharma AG, (Swiss
Regulatory Authorities Medic approved)
Me-too status Acabel 8mg Tablet by M/s Continental Pharma
b. DEFERRED CASES
963. Name and address of manufacturer / M/s Medicraft Pharmaceuticals, 126-B, Industrial estate
Applicant Hayatabad Peshawar
Brand Name +Dosage Form + Strength Ketrowin 30 mg/ ml injection
Composition Each ampoule contains:-
Ketorolac tromethamine as ketorolac……… 30 mg
Diary No. Date of R& I & fee Dy. No. 297; 8-8-2016; Rs. 20,000/-
Pharmacological Group Anti-inflammatory and anti-rheumatic products
Type of Form Form 5
Pack size & Demanded Price 1x1 ampoule: As per SRO
Approval status of product in Reference Ketorolac Tromethamine Injection 30mg/ml by M/s Hospira
Regulatory Authorities Pharmaceuticals, USFDA approved
Me-too status Toralac Injection 30mg/ml by M/s Vision Pharmaceuticals
GMP status Last GMP Inspection conducted on dated 30-01-2018 with
conclusive remarks of good cGMP compliance.
Remarks of Evaluator Decision of 284:
Deferred for clarification of applied composition
Remarks of evaluator:
Revised form 5 for ketorolac to methamine 30 mg/ml was
provide without fee.
Decision of 287:
Remarks of Evaluator: Revised form 5 as per innovator is provided.
Each ampoule contains:-
Ketorolac tromethamine ……… 30 mg
was provide with fee of 5000/- (Fee challan 0803231) dated
18/5/2019
Decision:Approved.
964. Name and address of manufacturer / M/s Dr Raza Pharma,44-C, industrial estate Hayatabad, Peshawar
Applicant
Brand Name +Dosage Form + Strength Lansozol 30 mg capsules
Lansoprazole (as enteric-coated 8.5% pellets)……30 mg
Diary No. Date of R& I & fee Dy.No. 3095, 30-4-2015, Rs.12,000/- (13-01-15), Rs.8000/-, (4-
March- 2011)
Pharmacological Group Anti-Peptic Ulcerant, Proton Pump Inhibitor
Type of Form Form-5
Pack size & Demanded Price 2x7‘s
As per SRO
Approval status of product in Reference Lansoprazole 30mg GR capsules of M/s Generics limited (UK
Regulatory Authorities. MHRA Approved)
Me-too status Inhibitol capsules 30mg of M/s Highnoon Laboratories
GMP status Last GMP Inspection conducted on 18.03.2017 with conclusive
remarks of cGMP.
Remarks of Evaluator Source of pellets Vision pharma.
Latest GMP
Decision of 283: Registration Board referred the case to QA & LT Division to conduct GMP inspection of
Firm on priority.
Last GMP Inspection conducted on 24-June 2019 with conclusive remarks of satisfactory cGMP.
Decision: Approved.
965. Name and address of manufacturer / M/s Noa Hemis Plot #154, Sector 23, Korangi industrial area
Applicant Karachi
Brand Name +Dosage Form + Strength Bianchi Syrup
Levocetirizine dihydrochloirde………5 mg
Diary No. Date of R& I & fee Dy.No. 1569, 4-8-2016, Rs.20,000/-
Pharmacological Group Anti-Histaminic
Type of Form Form-5
Finished Product Specification Innovators
Pack size & Demanded Price 60 ml / As per SRO
Me-too status Letirix Syrup of M/s Alliance Pharmaceuticals
GMP status Last GMP Inspection dated 17-11-16 with conclusive remarks
of cGMP compliance
Remarks of Evaluator Levocetirizine dihydrochloride 2.5mg/5ml oral solution is
available in USFDA
Decision of 274: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board in its 249th meeting.
Revised dossier is provided as under
Revised Dossier;
Name and address of manufacturer / M/s Noa Hemis Plot #154, Sector 23, Korangi industrial area
Applicant Karachi
Brand Name +Dosage Form + Strength Bianchi Syrup
Levocetirizine dihydrochloirde………2.5 mg
Diary No. Date of R& I & fee Dy.No. 7719, 21-2-2019, Rs. 5000/- (Challan # 0545425)
Pharmacological Group Anti-Histamin/Antiallergic
Type of Form Form-5
Pack size & Demanded Price 60 ml / As per SRO
Approval status of product in Reference Xyzal 0.5mg/ml oral solution of M/s UCB Pharma Limited
Me-too status Ocitra Syrup of M/s Searle Pakistan (Pvt.) Limited (Reg.
#054519)
GMP status Last GMP Inspection dated 28-2-2019 with panel recommend
grant of DML renewal
Decision: Deferred for submission of requisite fee for the revision of formulation.
Case No. 02: Registration Applications of Newly Granted DML or New Section (Human).
c. Deferred Cases New DML/New Section(s)
966. Name and address of manufacturer / M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207, Industrial
Applicant Triangle Kahuta Road Islamabad
M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207, Industrial Triangle Kahuta Road Islamabad
In response to licensing division letter dated 04-September, 2018 has considered the grant of following new
sections. Accordingly, firm has applied for following products for consideration by Drug Registration
Board.
Sr. No Section No. of products No. of molecules
1 Sterile Dry powder vials section (Steroid)
2 Sterile liquid ampoule section (Steroid)
3 Topical section (Steroid)
4 Eye/ear/Nose drops section (Steroid)
5 Warehouse (Steroid)
6 Sterile liquid Vial SVP section (General) 11 10
7 Liquid ampoule SVP section (General)
Brand Name +Dosage Form + Strength Tirostat 12.50mg/50ml Injection
Diary No. Date of R& I & fee Form-5 Dy.No 40226 dated 05-12-2018 Rs.20,000/-
Dated 05-12-2018
Composition Each 50ml Injection Contains:
Tirofiban as Hydrochloride Monohydrate…12.5mg
Type of Form Form-5
Finished Product Specification In-house Specification
Pack size & Demanded Price 100ml‘s, As per SRO
Approval status of product in Reference Aggrastat 250 mcg/ml concentrate for solution for infusion in
Regulatory Authorities. 50 ml Type I glass vial. (MHRA Approved)
Me-too status Aggrastat of atco laboratories limited
GMP status New section: 19 Sep 2018
Decision of 283: Deferred for evidence of approval of applied formulation with 100ml fill volume in
reference regulatory authorities which were adopted by Registration Board in its 275th meeting is required.
The firm provide the copy of form 5 in which the applied volume is 50 mlwhich is in accordance with
reference product present in reference regulatory authority (MHRA) which were adopted by Registration
Board in its 275th meeting is required.
967. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot # 31& 32 Punjab Small
Applicant Industrial Estate Taxila
Brand Name +Dosage Form + Strength Wemsin 0.4 mg capsule
Diary No. Date of R& I & fee Form-5 Dy.No 26462 (28-12-2012) Rs. 20,000/- 28-12-2017
Tamsulosin HCl 0.2% pellets……….0.4mg
Pharmacological Group Antivertigo preparations
Type of Form Form-5
Approval Status of Product in Reference Tamsulosin Zentiva 400 microgram prolonged-release hard
Regulatory Authorities. capsules (MHRA approved)
Me-too Status Talsin of Pharmedic (Pvt) Ltd
GMP status Last GMP inspection conducted on 29-10-2018, and the report
concluded that there is some need of improvement which have
been discussed and agreed. Panel recommend the grant of GMP
certificate.
Remarks of the Evaluator. In form 5 the strength of tamsulosin is different from strength
throughout dossier.
Form 5 is revised by the firm without fee
Decision of 287: Deferred for clarification of applied composition along with submission of fee for revision
of Form 5.
Revised form 5 as per innovator (MHRA approved) is provided.
Each modified release capsule contains:
Tamsulosin HCl ……….0.4mg (as modified released pellets)
Fee of 5000/- (Fee challan 01917517) dated 09/04/2019 is provided
Decision: Deferred for COA, GMP of pellet manufacturer along with stability studies data both
accelerated & real time conducted in accordance with zone IV-A conditions, and differential fee in
case of import of pellets.
968. Name and address of Manufacturer / M/s Liven pharmaceuticals 49, km, Multan road Lahore
Applicant
Brand Name+ Dosage Form+ Strength Vit-B 3 ml injection. IM/IV
B1 (Thiamine HCL)…33.33mg
B6 (Pyridoxine HCL)…33.33mg
B12 (Cyanocobalamin)…33.33mg
Diary No. Date of R&I & fee Dy No. 17338 ; 10-05-2018; Rs.20,000/- Dated 10-05-2018
Pharmacological Group Multivitamin
Type of Form Form-5
Pack Size & Demanded Price 3 ml, 5‘s, 10‘s, 25‘s / As per SRO
Approval status of product in Reference Neurobion ampoules by M/s Merck (Germany Approved)
Me-too status Bevidox 3ml Injection by M/s Abbott (Reg#008345)
GMP status New DML
Remarks of Evaluator The formulation‘s composition mentioned on Form 5 and
Master formulation is different which need clarification.
Decision of 285:
Deferred for evidence of approval of applied formulation in reference regulatory authority adopted by
Registration Board in 275th meeting.
Remarks of evaluator VII
Revised formulation is submitted
Each 3 ml Contains:
B1 (Thiamine HCL)…100 mg
B6 (Pyridoxine HCL)…100 mg
B12 (Cyanocobalamin)…1000 mcg
Fee of 20,000/- is provided (Deposit # 0817429, date: 01-02-2019)
Decision: Approved.

Case. No.1. M/s International Pharma Labs. Raiwind Road, Bhobtian Chowk, Defence Road, 1-KM
Towards Kahna, Lahore (Additional section)
CLB in its meeting held on 2 March, 2018 has considered and renew the grant of drug manufacturing license by
way of formulation with grant to following additional sections
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Sr. No Section No. of products No. of molecules
1 Liquid repacking section (human)
2 Powder repacking section (human)
3 Sachet section (General) for human
4 External preparations/
Application/Aerosol section for human
5 Liquid injectable section (steroid )
veterinary
6 Oral Powder section (penicillin)
veterinary
External section:
969. Name and address of manufacturer / M/s International Pharma Labs. Raiwind Road, Bhobtian
Applicant Chowk, Defence Road, 1-KM Towards Kahna, Lahore
Brand Name +Dosage Form + Strength Oxy-G Plus Spray (vet)
Diary No. Date of R& I & fee Form-5 Dy.No 30859-B dated 13-09-2018 Rs.20,000/- Dated 13-
09-2018
Oxytetracycline HCl…40mg
Gentian violet…4mg
Citronella oil…….20 mg
Permethrine……….10 mg
Type of Form Form-5
Finished Product Specification Manufacturer
Pack size & Demanded Price Price: 435/125 ml
700/200ml
Me-too status TERAGEN Plus AEROSOL SPRAY
GMP status Last GMP Inspection Conducted on December 19,2017 August
2018 with conclusive remarks of good compliance
Decision 287:Deferred for justification of applied dosage form in the section of ―Oral Powder
section (Penicillin) Veterinary‖
Remarks:
Firm inform that the applied formulation is under spray section newly approved by central licensing board.
Letter of CLB is not attached
Decision:Deferred for review of formulation & its drug delivery system as applied formulation is
spray & its ingredients are mentioned in grams.
970. Name and address of manufacturer / M/s International Pharma Labs. Raiwind Road, Bhobtian
Applicant Chowk, Defence Road, 1-KM Towards Kahna, Lahore
Brand Name +Dosage Form + Strength Oxy-G Spray (Vet)
Diary No. Date of R& I & fee Form-5 Dy.No 30859-C dated 13-09-2018 Rs.20,000/-
Dated 13-09-2018
Oxytetracycline HCl…40mg
Gentian violet…4mg
Type of Form Form-5
Pack size & Demanded Price 410/200 ml
256/125 ml
308/150ml
Me-too status TERAGEN AEROSOL SPRAY
Remarks of the Evaluator. •In cover letter it was mentioned that you are applying for
human drug, but on form 5 the price of the applied formulation
was claimed as decontrolled, which is claimed only for
veterinary product. Clarify.
Decision 287:Deferred for justification of applied dosage form in the section of ―Oral Powder
section (Penicillin) Veterinary‖
Remarks:
Firm inform that the applied formulation is under spray section newly approved by central licensing board.
Letter of CLB is not attached
Decision:Deferred for review of formulation & its drug delivery system as applied formulation is
spray & its ingredients are mentioned in grams.
Case no. 03 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
971. Name and address of Manufacturer / M/s Prix Pharmaceutical (Pvt) Ltd., Plot #5, pharma city, 30 km,
Applicant Multan road, Lahore.
Brand Name+ Dosage Form+ Strength Pri-Trichlor 100 water soluble powder
Composition Each g contains:-
Trichlorfon…………..980 mg
Diary No. Date of R&I & fee Dy No. 5878 ; 13-06-2018; Rs.20,000/-
Pharmacological Group Organophosphate acetylcholinesterase inhibitor.
Type of Form Form-5
Pack Size & Demanded Price 100gm, 500 gm, 1000 gm.
Decontrolled
Approval status of product in NA
Me-too status Seguvan Powdercontains, Trichlorphon 98% w/w of Symans
Pharma
GMP status Latest GMP inspection report dated 11-12-2018 concluding
renewal of grant of DML
Decision:Approved.
Brand Name+ Dosage Form+ Strength Amanta-Pri 10% oral liquid
Composition Each 100 ml oral liquid contains:-
Amantadine Hydrochloride…………..100 g
Diary No. Date of R&I & fee Dy No.2714 ; 5-05-2017; Rs.20,000/-
Pharmacological Group DOPAMINERGIC AGENTS
Type of Form Form-5
Finished Product Specification USP (oral Solution)
Pack Size & Demanded Price 100 ml, 250ml, 500 ml, 1000ml.
Decontrolled
Me-too status NA
Remarks of Evaluator  Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) can‘t be verified
Decision:Deferred for the following:
For evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
For Clarification regarding difference in label claim & composition.
Brand Name+ Dosage Form+ Strength Ketoflame 10 injection
Ketoprofen…………..100 mg
Type of Form Form-5
Pack Size & Demanded Price 100 ml glass vial
Decontrolled
Approval status of product in Comforion Vet 100 mg/ml Solution for Injection of Orion
Reference Regulatory Authorities Corporation, Finland (UK)
Me-too status Ketoject Injection of M/s Selmore Pharma (Reg # 043141)
Brand Name+ Dosage Form+ Strength Trocid 34 injection
Nitroxynil…………..340 mg
Pharmacological Group Dewormer/Anthelmintic
Type of Form Form-5
Pack Size & Demanded Price 100 ml glass vial
Decontrolled
Approval status of product in Trodax 34% w/v solution for injection by Merial Animal Health
Reference Regulatory Authorities Limited, UK
Me-too status Nitroxy injection of Alina Combine Pharma (Reg # 049683)

Brand Name+ Dosage Form+ Strength Atropri-injection
Atropine sulphate…………..1 mg
Pharmacological Group Antimuscrinic
Type of Form Form-5
Pack Size & Demanded Price 100 ml in glass vial
Decontrolled
Me-too status Atrovet Injection. 1mg/ml By Selmore Pharmaceuticals, Lahore
Decision:Approved with Japanese Pharmacopoeia Specifications.
b. Deferred Cases
Section: Oral Powder section (penicillin) veterinary
Brand Name +Dosage Form + Strength I-Amamox 80 gm Powder (Vet)
Diary No. Date of R& I & fee Form-5 Dy.No 31031-B dated 14-09-2018 Rs.20,000/- Dated 14-
09-2018
Amoxicillin as Trihydrate…80 gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 250 gm, 500 gm, 1 kg, 2.5 kg, 5 kg, 10 kg, 25 kg
Decontrolled
Me-too status NA
Remarks of the Evaluator. PRIMOX 70% WATER SOLUBLE POWDER of Prix can‘t be
verified
Decision 287:Deferred for evidence of applied formulation/drug already approved by DRAP
Remarks:
Firm revised the form 5 along with fee of 5000/- (0807341)
Each 100gm Water Soluble Powder Contains:-
Amoxicillin Trihydrate …….80g Equivalent To 70g Of Amoxicillin Base
Me too is confirmed. PRIMOX 70% WATER SOLUBLE POWDER ('074032)
Brand Name +Dosage Form + Strength I-Amoxical DS Powder
Diary No. Date of R& I & fee Form-5 Dy.No 31031-C dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Amoxicillin as Trihydrate…25gm
Colistin Sulphate…100mg
Type of Form Form-5
Decontrolled
Me-too status NA
Remarks of the Evaluator. Me too not verified, COLI-A Powder (044941) EACH 100GM
CONTAINS:- AMOXICILLIN SODIUM ..23GM. COLISTIN
SULPHATE… 100MIU.
Decision of 287: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
Remarks:
Firm revised the formulation along with Form 5 with 5000/-fee (Challan # 0807340)
Each 100gm Contains:
Amoxicillin Trihydrate…23 gm
Colistin Sulphate…100 MIU
Me-too status : Pentamox Water Soluble Powder (071018)

Brand Name +Dosage Form + Strength I-Colamox Powder
Diary No. Date of R& I & fee Form-5 Dy.No 31031-O dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Spectinomycin as HCL…5gm
Colistin Sulphate…50 MIU
Amoxicillin Trihydrate…10gm
Bromhexine HCL…0.5gm
Type of Form Form-5
Decontrolled
Me-too status COLIBAC-SP 160 POWDER of Nawan pharma
Decision:Deferred for evidence of applied formulation/drug already approved by DRAP
Remarks:
Me too, AS-PLUS WATER SOLUBLE POWDER (071063) is confirmed

Brand Name +Dosage Form + Strength Stepcin-C Powder
Diary No. Date of R& I & fee Form-5 Dy.No 26772-G dated 03-08-2018 Rs.20,000/-
Dated 03-08-2018
Composition Each KG Contains:
Colistin sulphate …60 MIU
Procaine Penicillin…12 gm
Streptomycin sulphate…..36 gm
Zinc bacitracin………….52 gm
Type of Form Form-5
Decontrolled
Me-too status PROCAIN SB WATER SOLUBLE POWDER (Not confirmed)
Decision of 287:Deferred for evidence of approval of applied formulation in reference regulatory
authorities/ agencies which were adopted by the Registration Board in its 275th meeting.
Remarks:
Me too is confirmed now, Procain Sb Plus Water Soluble Powder (058954)
Brand Name +Dosage Form + Strength Stepcin Powder
Diary No. Date of R& I & fee Form-5 Dy.No 26772-G dated 03-08-2018 Rs.20,000/- (Duplicate)
Dated 03-08-2018
Composition Each Kg Contains:
Procaine Penicillin…12gm
Streptomycin Sulphate…36gm
Zinc Bacitracin…(10%)25gm
Type of Form Form-5
Pack size & Demanded Price 5 gm, 10 gm, 25 gm, 50 gm, 100 gm, 200 gm, 250 gm, 500 gm, 1
kg, 2.5 kg, 5 kg, 10 kg, 15 kg, 2 kg and 25 kg
Decontrolled
Me-too status Procain Sb Water Soluble Powder (058955)
Remarks:
Each Kg Contains:
Procaine Penicillin…12gm
Streptomycin Sulphate…36gm
Zinc Bacitracin…50 gm
Me-too status : Procain Sb Water Soluble Powder (058955)
Brand Name +Dosage Form + Strength I-Amoxycol DS Powder (Vet)
Diary No. Date of R& I & fee Form-5 Dy.No 31031-L dated 14-09-2018 Rs.20,000/-
Dated 14-09-2018
Amoxicillin Trihydrate…200mg
Colistin Sulphate…600,000 MIU
Type of Form Form-5
Pack size & Demanded Price 5 gm, 10 gm, 25 gm, 50 gm, 100 gm, 200 gm, 250 gm, 500 gm, 1
kg, 2.5 kg, 5 kg, 10 kg, 15 kg, 2 kg and 25 kg
Decontrolled
Me-too status NA
Remarks of the Evaluator. Me too evidence not present
Remarks:
Each Gm Contains: -
Amoxycillin Trihydrate 200mg.
Colistin Sulphate 800,000 Units.
Me-Too Status Amoxycol Water Soluble Powder. (035110)
Case no. 04 Registration Applications of Import Cases.

a. Deferred cases
i. Human
982. Name and address of Applicant M/S Huaxing pharmaceuticals Pvt. Ltd. Address: 207,D1,
Nespak society district Lahore.
By
M/S Shandong Luoxin pharmaceutical group stock limited Road
Luo 7, High & New technology industries development zone,
Linyi city, Shandong province china.
Detail of Drug Sale License Address: Huaxing Pharmaceuticals (Pvt) Ltd.
Address: 207,D1, Nespak society district Lahore
Validity: 28-june 2018
Status: Drug License by Way of distributor
Name and address of manufacturer M/S Shandong Luoxin pharmaceutical group stock co. limited
Road Luo 7, High & New technology industries development
zone, Linyi city, Shandong province china.
Name and address of marketing Huaxing Pharmaceuticals (Pvt) Ltd.
authorization holder Address: 207,D1, Nespak society district Lahore
Name of exporting country People‘s republic of China
Diary No. & Date of R& I Dy. No.23500 Dated 6-07-2018
Fee including differential fee Rs. 100,000/- Dated 6-july-2018
Brand Name +Dosage Form + Strength Aciclovir tablet 0.1 g tablet
Composition Each tablet contain
Acyclovir…. 100 mg
Shelf life 24 month
Demanded Price 200 rupees per box
Pack size
International availability NA
Me-too status NA
Detail of certificates attached GMP certificate
(Translated Copy, attested)
Certificate No:SD20160446
Certifying Authority: China food and drug administration
Issue date: 25-1-2016
Valid date: 24-1-2021
COPP (Original, Embassy Attested)
Certificate No:LY2018-013
Certifying Authority: Shandong Linyi food and drug
administration
Issue Date:1-01-2016
Valid: 18-3-2019
Letter of Authorization (Copy)
Date of Agreement:12-march-2018 (Valid for 5 year)
Remarks of the Evaluator.  Label specimen was without the Urdu version which is
required as per The Drugs (Labelling and Packaging)
Rules, 1986 was Submitted
 Not found in any reference regulatory authority in this
strength
 Evidence of approval of applied formulation in DRAP
(me too status) Not approved in this strength
 Previously due to the location of the manufacturer and
the applicant initial stability study was carried out under
the condition of zone-II (25°C ± 2°C / 60% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) Stability data
for 3 batches is submitted . however on query new
stability specific to zone IV A (30°C ± 2°C / 65% ± 5%
RH Accelerated: 40°C ± 2°C / 75% ± 5% RH) firm
commit to complete the stability study of 3 commercial
batches up to shelf life.
 Detailed method of manufacturing of tablet was missing
on query it was Submitted
Decision of 286: Deferred for submission of stability study data as per zone IV A.
Remarks:
Stability data is not submitted.
Previously due to the location of the manufacturer and the applicant, initial stability study was carried out
under the condition of zone-II (25°C ± 2°C / 60% ± 5% RH).
However on query firm provides the undertaking to provide stability study of 3 commercial batches on Zone
IV-A conditions.
Decision: Deferred for submission of stability studies both accelerated & real time for three batches of
applied drug product conducted in accordance with zone IV-A conditions.
By
Address: 207, D1, Nespak society district Lahore
Brand Name +Dosage Form + Strength Aniracetam capsule 0.2 g
Composition Each Capsule contain
aniracetam…. 0.2 g
Finished Product Specification In-house
Pharmacological Group Antidepressant, Mental performance enhancer
Shelf life 24 month
Demanded Price 600 rupees per bottle
Pack size 18 capsules per bottle
International availability NA
Me-too status NA
Issue date: 10- July 2002
administration
Issue Date:9-12-2005
Valid: 18-3-2019/
Remarks of the Evaluator.  Submitted Label specimen is without the Urdu version
which is required as per The Drugs (Labelling and
Packaging) Rules, 1986
Submitted
Not approved in any reference regulatory authority
 Evidence of approval of applied formulation in DRAP (me
too status).
Not approved in DRAP
 Stability data is not submitted. Submit stability studies (long
term & accelerated) conducted under the conditions of zone
IV-A of 03 batches duly signed shall be submitted.
Not Provided
Previously due to the location of the manufacturer and the
applicant initial stability study was carried out under the
condition of zone-II (25°C ± 2°C / 60% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) Stability data for
3 batches is submitted . however on query new stability

specific to zone IV A (30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH) firm commit to
complete the stability study of 3 commercial batches up to
shelf life.
 Detailed method of manufacturing of tablet is missing
Submitted
 Complete protocols of stability studies are needed.
Submitted
Remarks:
However on query firm provides the undertaking to provide stability study of 3 commercial batches on Zone
IV-A conditions.
Decision:Deferred for submission of stability studies both accelerated & real time for three batches of
By
Brand Name +Dosage Form + Strength Calcium Folinate injection
Composition Each vial contain
Calcium folinate….100 mg
Demanded Price 1800 per vial
Pack size 1‘s vial
International availability Leucovorin Calcium 100 mg/vial (USFDA)
Me-too status leucovorin calcium (Atco)
COPP (Orignal, Embassy Attested)

administration
Issue Date:31-March-2005
Valid: 18-3-2019
Submitted
 Stability data is not submitted. Submit stability studies
(long term & accelerated) conducted under the conditions
of zone IV-A of 03 batches duly signed shall be submitted.
Not Provided
Accelerated: 40°C ± 2°C / 75% ± 5% RH) Stability data for 3
batches is submitted . however on query new stability specific
to zone IV A (30°C ± 2°C / 65% ± 5% RH Accelerated: 40°C
± 2°C / 75% ± 5% RH) firm commit to complete the stability
study of 3 commercial batches up to shelf life.
Submitted
Remarks:
Previously due to the location of the manufacturer and the applicant initial stability study was carried out
under the condition of zone-II (25°C ± 2°C / 60% ± 5% RH) However on query firm provides the
undertaking to provide stability study of 3 commercial batches on Zone IV-A conditions.
By: M/S Shandong Luoxin pharmaceutical group stock limited
Brand Name +Dosage Form + Strength Cefprozil tablet 0.25g
Composition Each Film coated tablet contain
Cefprozil…..0.2g
Pack size 8 tablets/box
International availability CEFPROZIL (CEFPROZIL) tablet LUPIN
Me-too status NA
COPP (Copy, Embassy Attested)
administration
Valid: 18-3-2019
Free Sale certificate: (Original)
Certificate No:LYFSC2018-003
Certifying Authority: Shandong food and drug administration
of the people‘s republic of china
Submitted
 Evidence of approval of applied formulation in DRAP (me
too status) not available.
Evidence of cefprozil capsule is provided not of tablet
Not Provided
shelf life.
Submitted
Decision of 286: Deferred for consideration on its turn with respect to the queue.
Remarks:
Previously due to the location of the manufacturer and the applicant initial stability study was carried out
under the condition of zone-II (25°C ± 2°C / 60% ± 5% RH) However on query firm provides the
undertaking to provide stability study of 3 commercial batches on Zone IV-A conditions.

By
Brand Name +Dosage Form + Strength Oxaliplatin injection
lyophilized powder for IV injections
Pharmacological Group Antineoplastic Drug
Demanded Price 10,000 rupies per vial
International availability ELOXATIN for injection (50mg 100mg) by M/s
SANOFI AVENTIS US, USFDA approved
Me-too status Me-too status Celdach 50 injection by Hakimsons (Reg # 72564)
administration
Issue Date: 11-Dec-2012
Valid: 18-3-2019
Free Sale certificate:

Submitted
Not Provided
shelf life.
 Finished product specifications (along with the official
monograph if the product is pharmacopoeial).
The firm has claimed In House manufacturing specifications
product contains Oxaliplatin and Lactose monohydrate while
according to formulation provided by the firm the product
also contain Oxaliplatin and lactose.
Submitted
Remarks:
Previously due to the location of the manufacturer and the applicant initial stability study was
carried out under the condition of zone-II (25°C ± 2°C / 60% ± 5% RH) However on query firm
provides the undertaking to provide stability study of 3 commercial batches on Zone IV-A
conditions.
By
Brand Name +Dosage Form + Strength Ambroxol HCL tablets

Composition Each tablet contain
ambroxol hydrochloride…. 30 mg
Finished Product Specification in-house
Pharmacological Group Respiratory system
International availability AMBROXOL ARROW 30 mg tablet (ANSM)
Me-too status FLUIBRON of CHIESI PHARMACEUTICALS
administration
Issue Date: 11-Dec-2012
Valid: 2020-2-7
Free Sale certificate:
Label with Urdu version is submitted
regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275th
meeting.
Approved in France
Not Provided
shelf life.
Submitted
Decision of 286: Deferred for consideration on its turn with respect to the queue.
Remarks:
Stability data is submitted.

However on query regarding stability specific to zone IV A (30°C ± 2°C / 65% ± 5% RH Accelerated: 40°C
± 2°C / 75% ± 5% RH) firm provides the stability study of 3 commercial batches for 6 months.
ii. Veterinary
market, Lahore.
Detail of Drug Sale License Address: M/s Vet line international Flat # 55/5, first floor, main
Renewal: 11-2-2019
Name and address of manufacturer M/s Range Pharma Sdn. Bhd. No.1, Jalan TSB 11, Taman
Industri Sungai Buloh, 47000 Sungai Buloh, Selangor Darul
Ehsan, Malaysia
Name and address of marketing M/s Range Pharma Sdn. Bhd. No.1, Jalan TSB 11, Taman
authorization holder Industri Sungai Buloh, 47000 Sungai Buloh, Selangor Darul
Ehsan, Malaysia
Brand Name +Dosage Form + Strength Neocin 49% Powder
Composition Each g Contains:
Neomycin as Sulphate…490 mg
Pharmacological Group Anti-infective
Shelf life 3 years
Pack size 100 g, 500 g, 1000g, 25 kg
International availability NA (present in 500 mg strength)
Me-too status NA
Detail of certificates attached Free Sale certificate (Original , Notary Attested, Embassy
attested)
Certificate No:CFS-025H/2017
Certifying Authority: NPRA ministry of health Malaysia
Issue Date: 31-May-2017
Certificate of pharmaceutical products (COPP):
Certificate No: 0476H/2017
Certifying Authority: Malysia Drug control authority
Date of issue: 27-July 2017
GMP certificate (Copy, Notary Attested, Embassy attested)
Certificate No:061/17
Certifying Authority: NPRA ministry of health Malaysia
Issue Date: 13-November 2015
Agency agreement:
(Notary Attested, Embassy attested)
Remarks of the Evaluator. Evidence of me too not provided, Provided reference
(DUFAMOX 50% WATER SOLUBLE POWDER)contain 500
mg/g not 490mg.
Decision of 287: Decision: Deferred for evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm. Remarks of the
Evaluator:
The firm provide the international reference of ―AQUAMICIN polvo‖ approved in Spain
(https://cimavet.aemps.es/cimavet/pdfs/es/p/1242+ESP/P_1242+ESP.pdf) but the provided reference has
Each g contains:
Neomycin sulfate ........................................490.000 IU
Not 490 mg.
The firm claim that 1000 IU =1 mg neomycin
Hence 490,000IU/g=490mg/g (Ref: Chines pharmacopeia)
Case No. 05 Registration Applications of Drugs for which Stability Study Data is Submitted
11 Name & Address of Brand Name Type of Form, International Availability
Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Fee / Local Availability
Dosage Form + (including differential
Strength), fee), GMP Inspection Report
Composition, Demanded Price / Pack Date & Remarks
Group,
Finished Product
Specification
989. M/s Getz Pharma (Pvt) Estine tablets 20 mg Form-5-D EBASTINE TEVA 20
Ltd., 29-30/27, Korangi Each orodespersable Dy. No: 11909 mg, France ANSM
Industrial Area, Karachi. tablet contains: Dated.6-6-2017 GMP inspection report
Ebastin….20 mg Rs.50,000/- (29-10-2015) conducted on Last
(Anti histamine) 10‘s ; Rs. 316/- inspection was conducted
on --------- with no
observation
Drug Estine tablets 20 mg
Name of Manufacturer M/s Getz Pharma (Pvt) Ltd., 29-30/27, Korangi Industrial Area, Karachi.
Manufacturer of API Ebastine : Bal Pharmaceuticals, unit II, 61-B Bommasandra industrial area
Bangalore
API Lot No. Ebastine: 500111706023
Description of Pack
Alu Alu blister
Accelerated:6 months
Frequency Accelerated: 0,3,6 (month)
Batch No. 418DS01 418DS02 418DS03

No. of Batches 03

No.
1. COA of API Yes
2. 0 Approval of API by regulatory authority of country Ebastine: Copy of GMP certificate issued Bal
of origin or GMP certificate of API manufacturer Pharmaceuticals limited, unit II, 61-B
issued by regulatory authority of country of origin. Bommasandra industrial area Bangalore .
Karnataka India. Dated 5 April 2018
Yes
5. Documents confirming import of API etc. Ebastine: Copy of commercial invoice has been
submitted issued by ADC, Karachi DRAP.
documents.
Yes
Yes
1978.
Sr.# Deficiency/Observation Response

i. On COA unit II is mentioned The Firm claimed that the GMP certificate provided is of the
clarification is required wethere same unit as mentioned on COS of AP. Declaration by Bal
GMP provided is of same plant or Pharma India states that the complete address of unit II I,e,
not? 61-B Bommasandra industrial area Bangalore 560 099, India
is in line with address mentioned in GMP certificate.
ii. Stability data of API from Provided
manufacturer is needed
iii. Clarification is required regarding This is to inform that every new entry 3 batches are
the time gap of almost 2 months manufactured. Therefore for the maximum utility of
between manufacturing and stability equipment, chemical reagents and analyst lean process
study as manufacturing date is 21-1- approach is being used in Getz pharma where we performed
2018 and stability study starting initial testing of all 3 batches of same product
date is 21-3-2108 simultaneously. Since the 3rd batch of estine 20 mg was
manufacture on 8-3-2018 therefore we complete the analysis
of all the 3 batches on 20-3-2018 and charge them on
stability on 21-3-2018
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Estine
(Ebastine) 10mg & 20mg Oro-dispersible Tablets by M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Industrial Area , Karachi.
Reference No: F.13-11/2017-PEC (Vol.I) dated 25th April, 2019.

Investigation Date and Time: 6th May, 2019. (Forenoon)
Investigation Site: Factory premises of M/s Getz Pharma Pvt. Limited, 29-30/27, Korangi
Background:
Chairman Registration Board considered the applications of M/s Getz Pharma Pvt. Limited, 29-30/27,
Korangi Industrial Area, Karachi for registration of Estine (Ebastine) 10mg & 20mg Oro-dispersible Tablets and
constituted a three member panel to investigate the authenticity / genuineness of data (import of raw material and
stability data). Panel was advised to conduct inspection of the firm and to submit report for further consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Dean Faculty of Pharmacy, Ziauddin University. (Member
Registration Board)
2. Dr. Kirshan Das, Assistant Director, DRAP, Karachi

Estine (Ebastine) Tablets 10mg & 20mg, Oro-dispersible Tablets
Q.# Question Observation by panel
1 Do you have documents confirming the The firm has imported ―Ebastine API‖ from M/s Bal
import of Ebastine API including approval Pharma Ltd, India and has approval from DRAP for
from DRAP? import vide License No.1657/17-DRAP (K) dated
21.06.2017.
2 What was the rationale behind selecting the There is proper vendor evaluation process being
particular manufacturer of API? implemented by the firm and the rationale behind vendor
selection is controlled through Postal Audit checklist /
Physical Site Inspection and availability of valid GMP
approval by competent authority. Further, M/s Bal
Pharma Ltd, India has Certificate of Suitability (CEP) for
Ebastine API issued by European Directorate for the
Quality of Medicines & HealthCare (EDQM).
3 Do you have documents confirming the Firm has imported Ebastine working standard from M/s
import of Ebastine reference standard and Bal Pharma Ltd, India vide invoice No. SAM-010 dated
impurity standards? 14.06.2017.
For impurity testing, firm has used Relative Retention
Time (RRT) for location and calculation of impurities as
provided by Ph. Eur.
4 Do you have certificate of Analysis of the The firm has certificate of analysis for API and working
API, reference standards and impurity standard.
standards?
5 Do you have GMP certificate of API Firm has provided copy of valid GMP certificate of M/s
manufacturer issued by regulatory authority Bal Pharma Ltd, India valid till 04-02-2020.
6 Do you use API manufacturer method of The firm has used method of testing adopted from
testing for testing API? European Pharmacopeia (Ph. Eur) monograph for
Ebastine API and the same has been verified as per USP
chapter 1226 (verification of compendial procedure)
7 Do you have stability studies reports on The firm has 5 years real time stability study data
API? provided by API manufacturer.
performed as per SIM method and method and degradation products have been quantified.
9 Do you have method for quantifying the Yes, the firm has method for quantifying the impurities in
impurities in the API? the API adopted from European Pharmacopeia (Ph. Eur)
monograph for Ebastine API.
10 Do you have some remaining quantities of The firm has some remaining quantities of the API and
the API, its reference standard and working standard.
11 Have you used pharmaceutical grade The firm have used pharmaceutical grade excipients
excipients? which include Microcrystalline Cellulose (Avicel PH-
101), Mannitol, Poloxamer 188, Povidone K-30,
Hypromellose, Carboxymethylcellulose Calcium,
Colloidal Anhydrous Silica, Croscarmellose Sodium,
Crospovidone, Aspartame, Trusil Powder Orange Flavour
and Magnesium Stearate.
12 Do you have documents confirming the The firm has necessary documents confirming the import
13 Do you have test reports and other records The firm has test reports and other records on the
on the excipients used? excipients used.
protocols for the development of Ebastine development of Ebastine Oro-dispersible Tablets 10mg &
tablets? 20mg.
15 Have you performed Drug-excipient The firm has performed Drug-excipient compatibility
compatibility studies? studies and concluded that the excipients used in the
proposed formulation of Ebastine Oro-dispersible Tablets
10mg & 20mg are compatible with the API.
16 Have you performed comparative The firm has used dissolution criteria as per Japanese
dissolution studies? Pharmacopoeia monograph for Ebastine Oro-dispersible
Tablets and the product complies. Further, this product is
orally dispersible which disintegrates very rapidly. The
release is more than 85% within 15 minutes, therefore, F2
waiver is applicable.
17 Do you have product development (R&D) The firm has dedicated product development (R&D)
section section with requisite manufacturing and analysis
facilities.
18 Do you have necessary equipment available The firm has necessary equipment available in product
in product development section for development section for development ofEbastine Oro-
development of Ebastine tablets? dispersible Tablets 10mg & 20mg.
20 Do you have proper maintenance / The firm has proper maintenance / calibration with re-
21 Do you have qualified staff in product The firm has qualified staff in product development
and training in product development? development. There are 50 Scientists (Pharmacist &
Chemist) working only in R&D Section.
22 Have you manufactured three stability The firm has manufactured three stability batches of
batches for the stability studies of Ebastine Ebastine Oro-dispersible Tablets 10mg & 20mg. Packed
tablets as required? in Alu-Alu blisters:


419DS04 March 2018 4000 Tablets
23 Do you have any criteria for fixing the batch The criteria for fixing the batch size of stability batches is
size of stability batches? the capacity of their R&D equipment where probable
simulation of manufacturing procedure of production
batches are expected as well as quantity of tablets
required per testing frequencies.
of stability batches? batches. All the Log Books are properly maintained.
25 Do you have protocols for stability testing of The firm has detailed protocols for stability testing of
stability batches? stability batches having protocol number:
418DS01 FS-019-18
418DS02 FS-020-18
418DS03 FS-021-18

419DS01 FS-022-18
419DS03 FS-023-18
419DS04 FS-024-18
method for testing of stability batches? testing of stability batches.
27 Do you have method transfer studies in case The firm has developed and validated method of testing
when the method of testing being used by for finished product and complete Method Validation
your firm is given by any other lab? Report is available. Therefore, method transfer is not
applicable.
qualification of equipments / instruments qualification of equipment / instruments being used in the
being used in the test and analysis of test and analysis of Ebastine API and the finished drug.
Ebastine API and the finished drug?
29 Do your method of analysis stability The firm has performed forced degradation (FD) study on
indicating? their product Ebastine Oro-dispersible Tablets 10mg &
20mg for the conformance of its stability indicating
nature.
30 Do your HPLC software 21CFR Compliant? The HPLC software is 21CFR Compliant as per record
available with the firm. The firm have WATER‘s HPLC
with Empower 3 software having following features:
 Have Audit trail
 Have backup system
 Have Data traceability
 Have Data achieving system
 Have data integrity
 Have Data security
System Security Policy
31 Can you show Audit trail reports on Audit trail on the testing reports is available.
Ebastine testing?
32 Do you have some remaining quantities of The firm has remaining quantities of stability batches.
33 Do you have stability batches kept on The firm has three stability batches kept on real time
stability testing? stability testing. 12 months real time stability data is
available.
equipments used in Ebastine tablets used in production and analysis of Ebastine Oro-
production and analysis? dispersible Tablets 10mg & 20mg.
35 Do proper and continuous monitoring and Adequate monitoring and control are available for
control are available for stability chamber? stability chamber. Chambers are controlled and monitored
through software having alarm system for alerts as well.
36 Do related manufacturing area, equipment, Related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are in compliance.
compliant?
Conclusions:
firm for registration of Estine (Ebastine) 10mg & 20mg Oro-dispersible Tablets is verifiable to
satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well
suited for the manufacturing of Estine 10mg & 20mg Oro-dispersible Tablets.
Recommendations:
The firm may kindly be granted necessary registration of Estine 10mg & 20mg Oro-dispersible tablets
Decision: Registration Board decided to approve registration of ―Ebastine tablets 20 mg by M/s
Getz Pharma (Pvt) Ltd., Karachi, with the change in brand name. Manufacturer will place first
three production batches of the product on long term stability studies throughout proposed shelf
No. Manufacturer / (Proprietary Name Initial Diary & Date, Fee Local Availability
Applicant + Dosage Form + (including differential fee),
Strength), Demanded Price / Pack GMP Inspection Report Date
Composition, size & Remarks
Pharmacological
Group,
Finished Product
Specification
990. M/s Sante Pvt Ltd Zithrosan 1% eye Form-5-D Azasite by Oak pharma
245/2-Z, Block 6, drops Dy. No: 09 (USFDA)
PECHS, Karachi 75400 Each 10 ml Dated: 31-1-2013 Last inspection was conducted
contains: Rs.20,000/- + 30,000 on 20-8-2018 for renewal /
Azithromycin as (Callan: 0033070, dated= grant of GMP Certificate and
dihydrate ……10 20/1/2014) Duplicated the report concludes good
mg 2.5 ml compliance of GMP.
(Anti-biotic) (Deferred in 245 meeting
In-house for application on Form-5
Specifications D and balance fee)
Drug Zithrosan 1% eye drops
Name of Manufacturer M/s Sante Pvt Ltd 245/2-Z, Block 6, PECHS, Karachi 75400
Manufacturer of API Azithromycin: Ningxia Qiyuan pharmaceuticals co. Ltd. No. 1 Street,
wangyuan industrial area, Yinchuan Ningxia China
API Lot No. 161015-1111
Description of Pack
2.5 ml filled in 5ml PP bottle, LDP nozzle and HDPE cap
Frequency Accelerated: 0,3,6 (month)

Batch No. 06T 07T 08T
Batch Size 1 liter 1 liter 1 liter

No. of Batches 03
Storage condition 2-8 ºC
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP certificate issued to M/s Ningxia Qiyuan
country of origin or GMP certificate of API pharmaceuticals co. Ltd. No. 1 Street, wangyuan industrial
manufacturer issued by regulatory authority of area, Yinchuan Ningxia China Issued by Ningxia food and
country of origin. drug administration
Yes
Yes
sheets etc.
5. Documents confirming import of API etc. Azithromycin:Copy of commercial invoice has been
submitted, manufacturer is M/s Ningxia Qiyuan
pharmaceuticals co. Ltd. No. 1 Street, wangyuan
industrial area, Yinchuan Ningxia China Issued by
ADC Karachi DRAP quantity issued of azithromycin
is 75 kg
6. All provided documents will be attested
Yes
Yes
Rules, 1978.
 The firm has provided 06 Months Accelerated and 6 Months Real Time Stability Data for 03 Batches.
Sr.# Deficiency/Observation Response by Pharma.
i. On submitted GMP certificate of Issuing authority is Ningxia food and drug administration
supplier of API (azithromycin),
issuing Drug regulatory authority is
not clear.
ii. Clarification is required, regarding Firm responded that, Due to change of HPLC system (as we
variation in run time of have 4 HPLC). Run time also depend upon source of organic
chromatograms in assay and solvents in mobile solvents in mobile phase. We use
dissolution analysis. ACN/MeOH of merck and sigma. Sometime run time shifts due
to weak signal strength of D2 lamp and also efficiently of
column may effect run time. Also USP states in most of its
methods, ―Make adjustments if necessary‖. Secondly if to
reduced tailing factors and peak adjustment, we change mobile

phase 4 to 5% (USP allowed 20%) the retention time shift.
Moreover the run time within the span of analysis is not varying
and the runtime of standard and sample during analyses is same
as per requirement.
iii. Detailed method of testing including Submitted
assay, pH and sterility etc. is not
provided along with the stability
protocols and specifications
iv. Clarification is required, since the Submitted
pack size and packaging material of
container
Report on Investigation of Authenticity / Genuineness of data submitted for registration of

Zithrosan 1% Eye Drops (Azithromycin as dehydrate) by M/s. Sante (Pvt). Ltd., 245/2-Z,
Block-6, PECHS, Karachi.

Investigation Site: Factory premises of M/s. Sante (Pvt). Ltd., Karachi.
Background:
Chairman Registration Board considered the applications of M/s Sante (Pvt). Ltd.,
Karachi for registration of Zithrosan 1% Eye Drops (Azithromycin as dehydrate) and constituted
a three-member panel to investigate the authenticity / genuineness of data (import of raw
material and stability data). Panel was advised to conduct inspection of the firm and to submit
report for further consideration.
2. Dr. Rafeeq Alam Khan, Meritorious Professor, Department of Pharmacology, University
of Karachi, Karachi, Member Registration Board, Islamabad.
3. Dr. Sidra Yasmeen, Assistant Director, DRAP Office, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and
stability data), manufacturing of stability batches and stability studies on these batches.

The investigation was conducted by using a structured questionnaire of DRAP. For
objective evidence physical inspection of the facilities for manufacturing and quality control,
material used and retained, personnel involved, ongoing studies, printed data and integrity and
security of data in respective databases were also audited. The details of investigation may be
summarized as under:
Sr.
No.
1 Do you have documents confirming the import The firm has used 34.26g quantities for
of API? manufacturing of three stability batches (1 litre
each) of Zithrosan 1% eye drops, from 75 kg API
(Azithromycin Dihydrate - tablet grade) imported for
production of their registered product, Azithromycin
tablets vide invoice No. 201610103 dated 25th
October, 2016 from M/S. Ningxia Qiyuan
Pharmaceutical Co. Ltd., China.
The firm has got proper approval from DRAP,

Sr.
No.
Office, Karachi.
2 What was the rationale behind selecting the No ophthalmic grade API has been imported by the
particular manufacturer of API? firm for manufacturing of stability batches of
Zithrosan 1% eye drops, however, the API primarily
imported for tablet manufacturing has been selected
as per approved vendor certification program.
of the API, reference standard of the API and API and working standard of the API. No impurity
impurity standards of the API? standard has been imported by the firm irrespective
of the fact that the API has a number of known
specified impurities like Azithromycin-N-oxide, N-
dimethyl Azithromycin, Azithromycin A, P etc.
4 Do you have certificate of Analysis of the API, The firm has certificates of analysis for the API and
reference standards and impurity standard? working standard of the API.
5 Do you have any approval of API or GMP The firm has GMP certificate of API manufacturer
certificate of API manufacturer issued by issued by the concerned regulatory authority of
regulatory authority of country of origin? country of origin (China).
6 Do you use API manufacturer method of The firm has used In-house method for testing of the
testing? API.
7 Do you have stability studies reports on API? The firm has stability studies reports on API
conducted by the API manufacturer.
performed as per SIM method and degradation method and degradation product have been
9 Do you have method for quantifying the The firm has method for quantifying the impurities in
impurities in the API? the API.
10 Do you have some remaining quantities of the The firm has some remaining quantities of the API
API, its reference standard and impurities and working standard of the API only.
standards?
11 Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients? The excipients include: Mannitol, Citric Acid
(Anhydrous), Sodium Citrate (Dihydrate), Poloxamer
407, Benzalkonium Chloride, CMC, Sodium
Chloride, EDTA &Sodium Hydroxide Pellets.
of the used excipients? some excipients; however, major excipients have
been purchased locally.
14 Do you have written and authorized protocols The firm has written and authorized protocols for the
for the development of Zithrosan 1% Eye development of Zithrosan 1% Eye Drops
Drops? (Azithromycin). However, the protocol has not been
used completely.
15 Have you performed Drug-excipient The firm has not performed Drug-excipients
compatibility studies? compatibility studies irrespective of the fact that the
formulation of Zithrosan 1% Eye Drops is different
from the innovator product (Azasite 1% Solution, by
M/s. Inspire Pharmacueticals, USA).
16 Have you performed comparative studies? The firm has not performed comparative studies with
the innovator product. The innovator product is even
not procured by the firm.
17 Do you have product development (R&D) The firm has an R&D Lab provided with some
section? equipment.
18 Do you have necessary equipment available in As Above.
product development section for development
Sr.
No.
of Eye Drops?
19 Are the equipment in product development The available equipment in product development
section qualified? section are qualified.
20 Do you have proper maintenance / calibration / The firm has SOP for the
re-qualification program for the equipment used maintenance/calibration/requalification of equipment
in PD section? used on PD section.
21 Do you have qualified staff in product The firm has 02 qualified staff (pharmacists) in
development section with proper knowledge manufacturing part whereas 04 personnel (03
and training in product development? chemists and 01 pharmacists) in analytical part of the
22 Have you manufactured three stability batches The firm has manufactured three stability batches for
for the stability studies of Zithrosan 1% Eye accelerated and real time stability studies of Zithrosan
Drops as required? 1% Eye Drops with batch No. 06T, 07T & 08T each
of 1Litre quantity. Tablet grade material has been
used with 5% overage for manufacturing of eye
drops. Literature survey of Azasite 1% ophthalmic
solution (innovator product) clearly indicate that the
eye drops are in solution form without any overage
whereas the firm‘s product is in suspension form with
5% overage. Moreover, the development protocol of
the firm shows that filteration be used for sterilization
of the final product however, the filteration process
for ophthalmic suspension is inappropriate process.
The firm actually has not sterilized the suspension
besides the fact that they have conducted the sterility
testing in the stability testing program.
23 What were the criteria for fixing the batch size The criteria for fixing the batch size of stability
of stability batches? batches is the number of test and their frequencies.
used have been available with the firm.
method for testing of stability batches? testing stability batches. However, the method is an
isocratic method being validated without the use of
impurity standards and forced degradation studies
hence the method is non-stability indicating and not
validated properly as per guidelines.
27 Do you have method transfer studies in case Not applicable at this stage.
when the method of testing being used by your
firm is given by any other lab?
28 Do you have documents confirming the The firm has documents confirming the qualification
used in the test and analysis of API and the analysis of API and finished drug.
finished drug?
29 Do your method of analysis stability indicating? The method of analysis is not stability indicating. The
accelerated stability studies report (Batch # 08T)
show the assay results as under:
100.14% (0 month), 107.78% (3 months) and
114.55% (6 months). Hence there is significant
change within three months time. The real time
stability reports on all three trial batches (06T, 07T
and 08T) show that the assay results have crossed the

Sr.
No.
specifications (90.0 % to 110.0%) at 12 months i.e.
Batch # 06T (118.81%), 07T (118.94%) and 08T
(119.53%) respectively. The firm container closure
system is LDPE bottle with HDPE caps however, no
water loss studies have been conducted by the firm as
required for LDPE containers.
31 Can you show Audit Trail reports on API and The firm showed the audit trail reports on API and
finish product testing ? finish product testing.
32 Do you have some remaining quantities of The firm has some remaining quantities of stability
degradation products and stability batches? batches only.
33 Do you have stability batches kept on real time The firm has completed the accelerated and real time
stability testing? stability testing. The results of study do not conform
to the designed specifications.
34 Do you have valid calibration status for the The firm has valid calibration status for the
equipment used in the production and analysis equipment used in Zithrosan 1% Eye Drops
of API and Eye Drops? production and analysis.
35 Do proper and continuous monitoring Continuous power supply and monitoring are
and control are available for stability available for stability chambers, however currently
chamber? there is no pack of Azithrosan 1% Eye Drops
available in the chambers as the study has already
been completed.
personnel and utilities be rated as GMP and utilities be rated as GMP compliant.
compliant?
Conclusions:
1. The firm has used 34.26g quantities for manufacturing of three stability batches (1 litre each)
of Zithrosan 1% eye drops, from 75 kg API (Azithromycin Dihydrate - tablet grade) imported for
production of their registered product, Azithromycin tablets vide invoice No. 201610103 dated 25 th
October, 2016 from M/S. Ningxia Qiyuan Pharmaceutical Co. Ltd., China.
2. The firm has not performed comparative studies with the innovator product. The innovator
product is even not procured by the firm.
3. The firm has manufactured three stability batches for accelerated and real time stability studies of
Zithrosan 1% Eye Drops with batch No. 06T, 07T & 08T each of 1Litre quantity. Tablet grade material
has been used with 5% overage for manufacturing of eye drops. Literature survey of Azasite 1%
ophthalmic solution (innovator product) clearly indicate that the eye drops are in solution form without
any overage whereas the firm‘s product is in suspension form with 5% overage. Moreover, the
development protocol of the firm shows that filteration be used for sterilization of the final product
however, the filteration process for ophthalmic suspension is inappropriate process. The firm actually has
not sterilized the suspension besides the fact that they have conducted the sterility testing in the stability
testing program.
4. The firm has developed and validated the method for testing stability batches. However, the
method is an isocratic method being validated without the use of impurity standards and forced
degradation studies hence the method is non-stability indicating and not validated properly as per
guidelines.
5. The method of analysis is not stability indicating. The accelerated stability studies report (Batch #
08T) show the assay results as under:
100.14% (0 month), 107.78% (3 months) and 114.55% (6 months). Hence there is significant change
within three months time. The real time stability reports on all three trial batches (06T, 07T and 08T)
show that the assay results have crossed the specifications (90.0 % to 110.0%) at 12 months i.e. Batch #
06T (118.81%), 07T (118.94%) and 08T (119.53%) respectively. The firm container closure system is
LDPE bottle with HDPE caps however, no water loss studies have been conducted by the firm as
required for LDPE containers.
6. The firm has completed the accelerated and real time stability testing. The results of study do not
conform to the designed specifications.
Recommendations:
1. Keeping in view the above facts the genuineness / authenticity of stability data submitted by the
firm for registration of Zithrosan 1% Eye Drops (Azithromycin as dehydrate) is not verifiable.
2. Since significant change has been found within 03 months in accelerated stability studies,
although using non-stability indicated method which clearly indicate that the product is unstable and
extrapolated value of degradation will be outside the product specifications (Assay limit 90% - 110%)
even using non-stability indicating method.
3. The real time stability studies have also shown out of specification results at 12 months with
further increase at 18 months.
4. The firm must re-design / conduct their studies with proper ultra-fine grade API, properly
developed formulation and testing program including comparative studies using authentic reference
standards of API, impurities and innovator product with stability indicating method under the guidance of
proper product development staff.
Decision: Registration Board deliberated that applied product is me too / generic drug
product and thus its product development data is required before sale of drug as
done in all other cases. After thorough deliberation, the Board decided to approve
the registration of Zithrosan 1% Eye Drops (Azithromycin as dihydrate) based on
availability of other generics of applied drug Product. As panel has identified
shortcomings thus firm shall repeat product development and registration letter
shall be issued after submission of data.
b. Exemption from onsite verification of stability data

Applicant Form + Strength), Fee (including Availability
Pharmacological Group, Demanded Price / Pack GMP Inspection Report
Finished Product Specification size Date & Remarks
991. M/s Ferozsons ARTRIL Tablets 24mg/26mg Form-5 USFDA. ENTRESTO
Laboratories Each film coated tablet Dy. No: 3449 by M/s Novartis
Limited contains Dated.25-01-2019
P.O Ferozsons, Sacubitril….24mg Rs.20,000/- Sacuvan tablets 24/26mg
Amangarh, (Neprilysin inhibitor) (21-01-2019) of GETZ pharma
Nowshera, KPK- Valsartan…..26mg (Challan # 0788889)
Pakistan (Angiotensin II Receptor As per SRO. The firm was granted
Antagonists) GMP certificate based
As Sacubitril + Valsartan on inspection conducted
trisodium hemipentahydrate on dated 10-01-2018.
Firm has claimed Mfg. Specs.

Drug ARTRIL Tablets 24mg/26mg
Name of Manufacturer M/s Ferozsons Laboratories Limited
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co, Ltd – China No.2 Tonghai Si Road,
Yangkou Chemical Industrial Park, Rudong Coastal Economic Development Zone,
Nantong, Jiangsu Province 226407, P.R. China
API Lot No. 201706001
Description of Pack
Alu/Alu blister packed in unit carton (1x14‘s)

Stability Storage Real time : 30°C ± 2°C / 75% ± 5% RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5% RH
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (month)
Real Time: 0, 3, 6 (month)
Batch No. SVTab-004 SVTab-005 SVTab-006

Date of Initiation 11-06- 2018 11-06- 2018 11-06- 2018
No. of Batches 03
Date of Submission 1-2-2019 (Dy. No.4653)
No.
1. COA of API Copy of COA from M/s Nantong Chanyoo
Pharmatech Co, Ltd – China is submitted
2. Approval of API by regulatory authority of country Copy of GMP Certificate issued on December 06,
of origin or GMP certificate of API manufacturer 2016 by Nantong Chemical & Medical Industry
issued by regulatory authority of country of origin. Association, People‘s Republic of China is
submitted valid till Dec 2019
Yes
5. Documents confirming import of API etc. Copy of Form 6 issued by ADC Peshawar DRAP
along with Form 3, Form 7, packing list,
commercial invoice and goods declaration has
been submitted.
Import quantity: 2 kg
Batch #: 201706001
Working standard:
Batch #: WS201610001
Impurities: Provided
Address of Exporter:
M/s Changzhou Pharmaceutical Factory, 518
Laodong East Road, Changzhou, Jiangsu
Province, China
Address of Consignee:
M/s Ferozsons Laboratories Limited. P.O
Ferozsons Amangarh, Nowshera, KPK-Pakistan
documents.
Yes
Yes
1978.

Dissolution:
Sacubitril/Valsartan: Tablet II (Paddle) 50, Phosphate Buffer, pH 6.8[degassed], 900,10, 15, 20, 30 and 45
inspection for instant dosage ―INVICTA TABLETS‖ (Sofosbuvir 400mg and Velpatasvir 100mg),
form conducted during last two which was conducted on 16-March 2018 and was presented in 281st
years. meeting of Registration board. Registration Board decided to approve
registration of ―INVICTA TABLETS‖ by M/s. Ferozsons Laboratories
Limited. According to the report following points were confirmed
2. Documents for the procurement The firm has submitted photocopies of ADC (Peshawar) attested Form
of API with approval from 6 dated 01/06/2017, Commercial Invoice for 2kg via Invoice #
DRAP (in case of import). CY117235 dated: 26/06/2017 lot No. 201706001 from M/s.
Changzhou Pharmaceutical Factory, 518 Laodong East Road,
Changzhou, Jiangsu Province, China vide proper approval from DRAP
Office, Peshawar.
3. Documents for the procurement The reference and impurity standards were received free of cost with
of reference standard and API i.e. Sacubitril + Valsartan trisodium hemipentahydrate.
impurity standards.
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on December 06, 2016 by Nantong
certificate of API manufacturer Chemical & Medical Industry Association, People‘s Republic of China
issued by regulatory authority is submitted
qualification
6. Certificate of analysis of the  API
API, reference standards and Photocopy of COA of Batch No. 201706001 issued by M/s Nantong
impurity standards Chanyoo Pharmatech Co, Ltd – China is submitted.
 Reference standards and impurity standards:
The firm has submitted the copy of COA‘s of Working Standard and
Impurity standards of API provided by the API Manufacturer M/s
Nantong Chanyoo Pharmatech Co, Ltd - China
development?
8. List of qualified staff involved Firm has submitted list of 10 qualified persons
in product development with
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of SOP with the title ‗Protocol For
the development & stability Development of generic product Artril Tablets (Sacubitril
testing of trial batches. 24mg/Valsartan 26mg) ‘.
10. Complete batch manufacturing Firm has provided complete batch manufacturing record of all the three
ARTRIL Tablets 24mg/26mg

Batch No. Bach size Mfg. Started Mfg.
Completed
SVTab-004 2500 Tabs 29-05-2018 31-05-2018
SVTab-005 2500 Tabs 30-05-2018 01-06-2018
SVTab-006 2500 Tabs 31-05-2018 01-06-2018
of stability batches. Artril Tablet 24mg/26mg ; Stability Pack Size : 1 x 14‘s)
 SVTab-004: Batch Size : 2500 Tablets
58 packs (Stability samples) For Accelerated (22 Packs) For Long
Term (36 Packs)
Term (36 Packs)
Term (36 Packs)
QA/QC DATA
chambers (real time and  Previously Reported in panel inspection:
accelerated) The firm has stability chamber for carrying out accelerated and real
time stability studies provided with uninterrupted power supply and
data loggers.
14. Method used for analysis of Firm has provided method used for analysis of FPP and complete
FPP & complete record of record of testing of stability batches including chromatograms, lab
testing of stability batches (i.e. reports and raw data sheets are submitted with 06 months stability data
chromatograms, lab reports, (Accelerated & Real Time).
15. Reports of stability studies of The firm has submitted copy of accelerated, 06 Months (40°C ± 2°C
API from manufacturer. & 75±5%RH) , long term, 18 Months (25°C ± 2°C & 60±5%RH),&
stability study reports of 03 batches of Sacubitril/Valsartan Complex
(LCZ696) from M/s Nantong Chanyoo Pharmatech Co., Ltd., China
16. Analysis reports for excipients The firm has submitted copy of Manufacturer‘s COAs and Firm
used. analysis reports for the excipients used in the applied formulation.
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility studies and
studies. has referred to the Innovator Product (ENTRESTO Tablets).

dissolution data. product Entresto Tablets manufactured by Novartis Singapore
Pharmaceutical.
Brand name Entresto Tablets Artril Tablets 24mg/26mg
24mg/26mg
Batch No. FX000011 SVTab-004
Mfg. date Exp. 01-2020 05-2018
pH buffer 0.01N Solution
pH 4.5 Acetate buffer solution.
pH 6.8 phosphate buffer solution.
• Copy of Calculation Sheets and HPLC chromatograms has
been submitted for Comparative dissolution studies
Evaluation by PEC:
i. • On commercial invoice M/S It is to clarify that as per provided invoice M/s Changzhou
Changzhou pharmaceutical is Pharmaceutical Factory – China is a Beneficiary‘s name
mentioned while COA and GMP and Manufacturer name is Nantong Chanyoo Pharmatech
provided is of M/S Nantong Jiangsu Co, Ltd – China
china. Clarification needed. Moreover STATEMENT that Nantong Chanyoo
Pharmatech Co, Ltd –China is wholly owned subsidiary of
M/s Changzhou Pharmaceutical Factory – China is also
provided
ii. Stability of API is on 25°C ± 2°C & Stability studies report of API as per condition of Zone IV-
60±5%RH A is submitted
iii. Extra peak on some chromatograms The extra peaks in some chromatograms are of solvent
I.e. SVT-004-603.icd, SVT-004- Solvent pH 1.2 is used as media to conduct comparative
602.icd dissolution profile
Chromatograms showing only solvent pH 1.2 peaks obtain
are also provided.
iv. Comparative dissolution raw data Provided
sheets
v. The initiation date is 6/2018 but the The chromatograms are not of 2017. Whereas the sample:
date on chromatograms are of 2017. QC NO.R-8937 & 201709011 is sample identification
(sample: QC NO.R-8937 number and not the date.
&201709011) Clarification is needed
Moreover each and every chromatogram has its own date at
which analysis was conducted. Chromatograms with
highlighted dates are provided
Decision: Registration Board decided to approve registration of ―ARTRIL Tablets 24mg/26mg
(Sacubitril….24mg & Valsartan…..26mg) by M/s Ferozsons Laboratories Limited,
Nowshera, KPK-Pakistan, with the change in brand name. Manufacturer will place first three production
batches of the product on long term stability studies throughout proposed shelf life and on accelerated
studies for six months.

Pack size Remarks
992. M/s Ferozsons ARTRIL Tablets 97mg/103mg Form-5 USFDA. ENTRESTO
Laboratories Each film coated tablet contains Dy. No: 3450 by M/s Novartis
Limited Sacubitril….97mg Dated.25/01/2019
P.O Ferozsons, (Neprilysin inhibitor) Rs.20,000/- Not applicable
Amangarh, Valsartan…..103mg (Challan #0788890 )
Nowshera, KPK- (Angiotensin II Receptor As per SRO The firm was granted
Pakistan Antagonists) GMP certificate based
As Sacubitril + Valsartan on inspection
trisodium hemipentahydrate conducted on dated 10-
01-2018.
Firm has claimed Mfg. Specs.

Drug ARTRIL Tablets 97mg/103mg
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co, Ltd – China
No.2 Tonghai Si Road, Yangkou Chemical Industrial Park, Rudong Coastal
Economic Development Zone, Nantong, Jiangsu Province 226407, P.R.China
API Lot No. 201706001
Description of Pack
Batch No. SVTab-007 SVTab-008 SVTab-009

No. of Batches 03
No.
1. COA of API Copy of COA from M/s Nantong Chanyoo
Pharmatech Co, Ltd – China is submitted
2. Approval
0 of API by regulatory authority of country of Copy of GMP Certificate issued on December
origin or GMP certificate of API manufacturer issued 06, 2016 by Nantong Chemical & Medical
by regulatory authority of country of origin. Industry Association, People‘s Republic of
China is submitted.
th
5. Documents confirming import of API etc. Copy of Form 6 issued by ADC Peshawar
DRAP along with Form 3, Form 7, packing
list, commercial invoice and goods declaration
has been submitted.
Batch #: 201706001
Working standard:
Batch #: WS201610001
Address of Exporter:
M/s Changzhou Pharmaceutical Factory, 518
Laodong East Road, Changzhou, Jiangsu
Province, China
Ferozsons Amangarh, Nowshera, KPK-
Pakistan
documents.
Yes
Yes
1978.

inspection for instant dosage ―INVICTA TABLETS‖ (Sofosbuvir 400mg and Velpatasvir 100mg),
form conducted during last two which was conducted on 16-March 2018 and was presented in 281st
years. meeting of Registration board. Registration Board decided to approve
registration of ―INVICTA TABLETS‖ by M/s. Ferozsons Laboratories
Limited. According to the report following points were confirmed
2. Documents for the procurement The firm has submitted photocopies of ADC (Peshawar) attested Form
of API with approval from 6 dated 01/06/2017, Commercial Invoice for 2kg via Invoice #
DRAP (in case of import). CY117235 dated: 26/06/2017 lot No. 201706001 from M/s. Changzhou
Pharmaceutical Factory, 518 Laodong East Road, Changzhou, Jiangsu
Province, China vide proper approval from DRAP Office, Peshawar.
3. Documents for the procurement The reference and impurity standards were received free of cost with
of reference standard and API i.e. Sacubitril + Valsartan trisodium hemipentahydrate. Copy of
impurity standards. packing list and commercial invoice provided
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on December 06, 2016 by Nantong
certificate of API manufacturer Chemical & Medical Industry Association, People‘s Republic of China
issued by regulatory authority is submitted
qualification
6. Certificate of analysis of the  API
API, reference standards and Photocopy of COA of Batch No. 201706001 issued by M/s Nantong
impurity standards Chanyoo Pharmatech Co, Ltd – China is submitted.
The firm has submitted the copy of COA‘s of Working Standard and
Impurity standards of API provided by the API Manufacturer M/s
Nantong Chanyoo Pharmatech Co, Ltd - China
development?
8. List of qualified staff involved Firm has submitted list of 10 qualified persons
in product development with
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of SOP with the title ‗Protocol For
the development & stability Development of generic product Artril Tablets (Sacubitril
testing of trial batches. 97mg/Valsartan 103mg) ‘.
10. Complete batch manufacturing Firm has provided complete batch manufacturing record of all the three
ARTRIL Tablets 97mg/103mg
SVTab-007 950 Tabs 14-05-2018 17-05-2018

SVTab-008 950 Tabs 18-05-2018 19-05-2018
SVTab-009 950 Tabs 20-05-2018 21-05-2018
of stability batches. Artril Tablet 97mg/103mg ; Stability Pack Size : 1 x 14‘s)
Term (19 Packs)

Term (19 Packs)

Term (19 Packs)
QA/QC DATA
chambers (real time and  Previously Reported in panel inspection:

accelerated) The firm has stability chamber for carrying out accelerated and real
time stability studies provided with uninterrupted power supply and
data loggers.
14. Method used for analysis of Firm has provided method used for analysis of FPP and complete
FPP & complete record of record of testing of stability batches including chromatograms, lab
testing of stability batches (i.e. reports and raw data sheets are submitted with 06 months stability data
chromatograms, lab reports, (Accelerated & Real Time).
15. Reports of stability studies of The firm has submitted copy of accelerated, 06 Months (40°C ± 2°C
API from manufacturer. & 75±5%RH) , long term, 18 Months (25°C ± 2°C & 60±5%RH),&
stability study reports of 03 batches of Sacubitril/Valsartan Complex
(LCZ696) from M/s Nantong Chanyoo Pharmatech Co., Ltd., China
16. Analysis reports for excipients The firm has submitted copy of Manufacturer‘s COAs and Firm
used. analysis reports for the excipients used in the applied formulation.
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility studies and
studies. has referred to the Innovator Product (ENTRESTO Tablets).
dissolution data. product Entresto Tablets manufactured by Novartis Singapore
Pharmaceutical.
Brand name Entresto Artril Tablets
Tablets 97mg/103mg
97mg/103mg
Batch No. F0005 SVTab-008
Mfg. date Exp. 12-2018 05-2018
Evaluation by PEC:
i. • On commercial invoice M/S It is to clarify that as per provided invoice M/s Changzhou
Changzhou pharmaceutical is Pharmaceutical Factory – China is a Beneficiary‘s name and
mentioned while COA and GMP Manufacturer name is Nantong Chanyoo Pharmatech Co, Ltd
provided is of M/S Nantong Jiangsu – China
china. Clarification needed. Moreover STATEMENT that Nantong Chanyoo Pharmatech
Co, Ltd –China is wholly owned subsidiary of M/s
Changzhou Pharmaceutical Factory – China is also provided
ii. Stability of API is on 25°C ± 2°C & Stability studies report of API as per condition of Zone IV-A
60±5%RH is submitted
iii. Extra peak on some chromatograms The extra peaks in some chromatograms are of solvent
I.e. SVT-004-603.icd, SVT-004- Solvent pH 1.2 is used as media to conduct comparative
602.icd dissolution profile
Chromatograms showing only solvent pH 1.2 peaks obtain
are also provided.
iv. Comparative dissolution raw data Provided
sheets

v. The initiation date is 6/2018 but the The chromatograms are not of 2017. Whereas the sample:
date on chromatograms are of 2017. QC NO.R-8937 & 201709011 is sample identification
(sample: QC NO.R-8937 number and not the date.
&201709011) Clarification is needed
Moreover each and every chromatogram has its own date at
which analysis was conducted. Chromatograms with
highlighted dates are provided.
Decision: Registration Board decided to approve registration of ―ARTRIL Tablets 97mg/103mg
(Sacubitril….97mg & Valsartan…..103mg) by M/s Ferozsons Laboratories Limited, Nowshera, KPK-
Pakistan, with the change in brand name. Manufacturer will place first three production batches of the
product on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.

Finished Product Specification size Date & Remarks
993. M/s Ferozsons SOLYXA Tablets 5mg Form-5 USFDA. VESICARE
Laboratories Each film coated tablet Dy. No: 6563 by M/s Astellas Pharma
Limited contains Dated.14-2-19 USA
P.O Ferozsons, Solifenacin succinate….5mg Rs.20,000/-
Amangarh, (Antimuscarinics) (22-May-2017) Fenaso of Highnoon
Nowshera, KPK- As per SRO Laboratories Ltd.
Pakistan Firm has claimed Mfg. Specs.
The firm was granted
GMP certificate based
on inspection conducted
on dated 10-01-2018.

Drug SOLYXA Tablets 5mg
Name of Manufacturer M/s Ferozsons Laboratories Limited P.O Ferozsons, Amangarh, Nowshera, KPK-
Pakistan
Manufacturer of API M/s Jubilant Generics Limited – India
Plot # 18, 56, 57 and 58, KIADB Industrial Area, Nanjangud, Mysore, Karnataka
571302, India
API Lot No. 7SLF317008
Description of Pack
Batch No. SSTab-004 SSTab-005 SSTab-006

No. of Batches 03
No.
1. COA of API Copy of COA from Jubilant Generics Limited –
India is submitted
2. Approval of API by regulatory authority of country Copy of GMP Certificate (DCD/CR-125/SPL.CL-
of origin or GMP certificate of API manufacturer /2018-19) issued on April 23, 2018 by Office of
issued by regulatory authority of country of origin. the Drugs Controller For the State of Karnataka,
Palace Road, Bangalore-560 001-India is
submitted.
Yes
5. Documents confirming import of API etc. Copy of Form 6 issued by ADC Peshawar DRAP
along with copy of DRAP acknowledgement
regarding intimation of receiving of Solifenacin
succinate 150gm along with working standard
250mg and impurities standards 5x10mg from
M/s Jubilant Generics Limited - India
API Batch #: 7SLF317008
Working standard Batch #: SLF/R0019/045
Address of Manufacturer:
M/s Jubilant Generics Limited – India
Plot # 18, 56, 57 and 58, KIADB Industrial Area,
Nanjangud, Mysore, Karnataka 571302, India
Ferozsons Amangarh, Nowshera, KPK-Pakistan
documents.
Yes
Yes
1978.

inspection for instant dosage form ―INVICTA TABLETS‖ (Sofosbuvir 400mg and Velpatasvir
conducted during last two years. 100mg), which was conducted on 16-March 2018 and was
presented in 281st meeting of Registration board. Registration
Board decided to approve registration of ―INVICTA TABLETS‖
by M/s. Ferozsons Laboratories Limited. According to the report
following points were confirmed
 Related manufacturing area equipment‘s personals and
utilities were found GMP compliant.
2. Documents for the procurement of The firm has submitted Copy of Form 6 # 00425/2017-
API with approval from DRAP (in DRAP(P)/1550 dated: 01-06-2017 issued by ADC Peshawar
case of import). DRAP along with copy of DRAP acknowledgement dated: 06-
10-2017, regarding intimation of receiving of Solifenacin
succinate 150gm along with working standard 250mg and
impurities standards 5x10mg from M/s Jubilant Generics
Limited – India
3. Documents for the procurement of The reference and impurity standards were received free of cost
reference standard and impurity with API i.e. Solifenacin succinate. Copy of DRAP
standards. acknowledgement regarding intimation of receiving of
Solifenacin succinate 150gm along with working standard
250mg and impurities standards 5x10mg from M/s Jubilant
Generics Limited – India is attached.
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on April 23, 2018 by Office of
certificate of API manufacturer issued the Drugs Controller For the State of Karnataka, Palace Road,
by regulatory authority of country of Bangalore-560 001-India is submitted
origin.
5. Mechanism for Vendor pre- Firm has submitted SOP ―Procedure for induction of new
qualification vendor‖
6. Certificate of analysis of the API,  API
reference standards and impurity Photocopy of COA of Batch No. 7SLF317008 issued by Jubilant
standards Generics Limited – India is submitted.
The firm has submitted the copy of COA‘s of Working Standard
and Impurity standards of API provided by the API Manufacturer
7. Documents for the procurement of Firm has submitted documents for procurement of excipients
development?
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of SOP with the title ‗Protocol For
development & stability testing of Development of generic product Solyxa 5mg and 10mg Tablets
trial batches. (Solifenacin succinate) ‘.
10. Complete batch manufacturing record Firm has provided complete batch manufacturing record of all
SOLYXA Tablets 5mg
Batch No. Bach Mfg. Started Mfg.
size Completed
SSTab-004 2500 02-04-2018 09-04-2018
Tabs
SSTab-005 2500 02-04-2018 09-04-2018
Tabs
SSTab-006 2500 02-04-2018 09-04-2018
Tabs

11. Record of remaining quantities of Firm has submitted following remaining quantities:
stability batches. Solyxa Tablet 5mg; Stability Pack Size : 1 x 10‘s)
 SSTab-004: Batch Size : 2500 Tablets
65 packs (Stability samples) For Accelerated (26 Packs) For
Long Term (39 Packs)
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of digital data logger for temperature
temperature and humidity monitoring and humidity monitoring control for the complete stability period
of stability chambers (real time and from
accelerated) 11-05-2018 to 11-01-2019
 Previously Reported in panel inspection:
The firm has stability chamber for carrying out accelerated and
real time stability studies provided with uninterrupted power
supply and data loggers.
13. Method used for analysis of API along Firm has provided the method used for analysis of API along
14. Method used for analysis of FPP & Firm has provided method used for analysis of FPP and complete
complete record of testing of stability record of testing of stability batches including chromatograms,
batches (i.e. chromatograms, lab lab reports and raw data sheets are submitted with 06 months
reports, raw data sheets etc.) stability data (Accelerated & Real Time).
15. Reports of stability studies of API The firm has submitted copy of accelerated, 06 Months (40°C ±
from manufacturer. 2°C & 75±5%RH) , long term, 60 Months (30°C ± 2°C &
65±5%RH),& stability study reports of 03 batches of Solifenacin
succinate from M/s Jubilant Generics Limited – India
16. Analysis reports for excipients used. The firm has submitted copy of Manufacturer‘s COA‘s and Firm
analysis reports for the excipients used in the applied
formulation.
17. Drug-excipients compatibility studies. The firm has not submitted Drug-excipients compatibility studies
and has referred to the Innovator Product (VESICARE Tablets).
18. Record of comparative dissolution Firm has submitted comparative dissolution profile with the
data. reference product Vesicare Tablets manufactured by Astellas
Pharma US, Inc.

Brand name Vesicare Solyxa Tablets 5mg
Tablets 5mg
Batch No. D1700004 SSTab-004

Mfg. date Exp. 12-2019 04-2018
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21
software 21CFR & audit trail reports CFR & audit trail reports
on product testing.
Evaluation by PEC:
i. The formula used to calculate the Firm claims that, As already mentioned in method of analysis
assay and dissolution is not correct. the concentration of sample & standard used in the assay and
Clarification is required for this dissolution is same. So, that‘s why the peak area of standard
regard. and sample was considered to calculate the percentage of
assay and dissolution
Formula
Peak area of sample
%age = ------------------- x 100
Peak area of standard
USP Reference is provided
ii. Clarification is required, regarding Firm responded that these inverted peaks or extra peaks are
inverted peaks in assay and of pure solvent peak used in the analysis method provided.
dissolution analysis (Dissolution: e.g. Moreover, the analytical method validation study. In which
Sample ID: B No. SSTAB-005) Assay the specificity is clarifying the solvent peaks
(Sample ID: B No. SSTAB-
005.103.lcd)
iii. Clarification is required, regarding Firm reply that, ―The difference of run time in dissolution
variation in run time of profile study is due to different media used and during study
chromatograms in assay and possibility of some extra peaks may be elute. Due to this
dissolution analysis. (Dissolution is on reason, run time increased to make sure the elution of these
5.5 min in chromatograms in volume extra peaks if any. That‘s why the run time increases up to
2/6) and 7 minutes in chromatograms one min more in the comparative dissolution profile study.
in volume 6/6) As this is only the study of our product dissolution behavior
in different media with innovator product‖.
iv. Why baseline is not stable in The comparative dissolution study is conducted in different
comparative dissolution pH media as recommended by the USP. The column behaves
chromatograms (e.g. in case of differently in different medias as a general rule. In case of
dissolution pH 4.5). Justify Acetate buffer media pH 4.5 the base line is stable and some
peaks of the media are observed as a normal consequence.
This is followed by the distinct peak of the active Solifenacin
succinate which is reproducible in all the runs. Therefore
there is no observed deviation.
Decision:Deferred for consideration of case on its turn, as applied formulation is a Me Too product, for
which submission of stability studies are not required at present.

Finished Product Specification Demanded Price / Pack Report Date &
size Remarks
994. M/s Ferozsons SOLYXA Tablets 10mg Form-5 USFDA.
Laboratories Each film coated tablet contains Dy. No: 22841 VESICARE by M/s
Limited Solifenacin succinate….10mg Dated.15-8-2018 Astellas Pharma
P.O Ferozsons, (Antimuscarinics) Rs.20,000/- USA
Amangarh, (22-May-2017)
Nowshera, KPK- Firm has claimed Mfg. Specs. Duplicate Fenaso of Highnoon
Pakistan As per SRO Laboratories Ltd.
The firm was granted

GMP certificate
based on inspection
conducted on dated
10-01-2018.
Drug SOLYXA Tablets 10mg
Manufacturer of API M/s Jubilant Generics Limited – India
Plot # 18, 56, 57 and 58, KIADB Industrial Area, Nanjangud, Mysore, Karnataka
571302, India
API Lot No. 7SLF317008
Description of Pack
Batch No. SSTab-001 SSTab-002 SSTab-003
No. of Batches 03
No.
1. COA of API Copy of COA from Jubilant Generics Limited
– India is submitted
2. Approval
0 of API by regulatory authority of country of Copy of GMP Certificate issued on April 23,
origin or GMP certificate of API manufacturer issued 2018 by Office of the Drugs Controller For the
by regulatory authority of country of origin. State of Karnataka, Palace Road, Bangalore-
560 001-India is submitted.
Yes
details of tests.
5. Documents confirming import of API etc. Copy of Form 6 issued by ADC Peshawar
DRAP along with copy of DRAP
acknowledgement regarding intimation of
receiving of Solifenacin succinate 150gm
along with working standard 250mg and
impurities standards 5x10mg from M/s
Jubilant Generics Limited - India
API Batch #: 7SLF317008
Working standard Batch #: SLF/R0019/045
Address of Manufacturer:
Plot # 18, 56, 57 and 58, KIADB Industrial
Area, Nanjangud, Mysore, Karnataka 571302,
India
Ferozsons Amangarh, Nowshera, KPK-
Pakistan
documents.
Yes

inspection for instant dosage form ―INVICTA TABLETS‖ (Sofosbuvir 400mg and Velpatasvir
conducted during last two years. 100mg), which was conducted on 16-March 2018 and was
presented in 281st meeting of Registration board. Registration
Board decided to approve registration of ―INVICTA TABLETS‖
by M/s. Ferozsons Laboratories Limited. According to the report
2. Documents for the procurement of The firm has submitted Copy of Form 6 # 00425/2017-
API with approval from DRAP (in DRAP(P)/1550 dated: 01-06-2017 issued by ADC Peshawar
case of import). DRAP along with copy of DRAP acknowledgement dated: 06-
10-2017, regarding intimation of receiving of Solifenacin
succinate 150gm along with working standard 250mg and
impurities standards 5x10mg from M/s Jubilant Generics
Limited – India
reference standard and impurity with API i.e. Solifenacin succinate. Copy of DRAP
standards. acknowledgement regarding intimation of receiving of
Solifenacin succinate 150gm along with working standard
250mg and impurities standards 5x10mg from M/s Jubilant
Generics Limited – India is attached.
4. Approval of API/ DML/GMP Copy of GMP Certificate issued on April 23, 2018 by Office of
certificate of API manufacturer issued the Drugs Controller For the State of Karnataka, Palace Road,
by regulatory authority of country of Bangalore-560 001-India is submitted
origin.
5. Mechanism for Vendor pre- Firm has submitted SOP ―Procedure for induction of new
qualification vendor‖
6. Certificate of analysis of the API,  API
reference standards and impurity Photocopy of COA of Batch No. 7SLF317008 issued by Jubilant
standards Generics Limited – India is submitted.
The firm has submitted the copy of COA‘s of Working Standard
and Impurity standards of API provided by the API Manufacturer
M/s Jubilant Generics Limited – India.

7. Documents for the procurement of Firm has submitted documents for procurement of excipients
development?
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of SOP with the title ‗Protocol For
development & stability testing of Development of generic product Solyxa 5mg and 10mg Tablets
trial batches. (Solifenacin succinate) ‘.
10. Complete batch manufacturing record Firm has provided complete batch manufacturing record of all
SOLYXA Tablets 10mg
Batch No. Bach size Mfg. Mfg.
Started Completed
SSTab-001 2500 Tabs 02-04-2018 07-04-2018
SSTab-002 2500 Tabs 02-04-2018 07-04-2018
SSTab-003 2500 Tabs 02-04-2018 07-04-2018
stability batches. Solyxa Tablet 10mg; Stability Pack Size : 1 x 10‘s)
QA/QC DATA
temperature and humidity monitoring and humidity monitoring control for the complete stability period
of stability chambers (real time and from
accelerated) 11-05-2018 to 11-01-2019
 Previously Reported in panel inspection:
The firm has stability chamber for carrying out accelerated and
real time stability studies provided with uninterrupted power
supply and data loggers.
13. Method used for analysis of API along Firm has provided the method used for analysis of API along
complete record of testing of stability record of testing of stability batches including chromatograms,
batches (i.e. chromatograms, lab lab reports and raw data sheets are submitted with 06 months
reports, raw data sheets etc.) stability data (Accelerated & Real Time).
15. Reports of stability studies of API The firm has submitted copy of accelerated, 06 Months (40°C ±
from manufacturer. 2°C & 75±5%RH) , long term, 60 Months (30°C ± 2°C &
65±5%RH),& stability study reports of 03 batches of Solifenacin
succinate from M/s Jubilant Generics Limited – India
16. Analysis reports for excipients used. The firm has submitted copy of Manufacturer‘s COA‘s and Firm
analysis reports for the excipients used in the applied
formulation.
17. Drug-excipients compatibility studies. The firm has not submitted Drug-excipients compatibility studies
and has referred to the Innovator Product (VESICARE Tablets).
18. Record of comparative dissolution Firm has submitted comparative dissolution profile with the
data. reference product Vesicare Tablets manufactured by Astellas
Pharma US, Inc.
Brand name Vesicare Tablets Solyxa Tablets 10mg
10mg
Batch No. E1700232 SSTab-001
Mfg. date Exp. 02-2020 04-2018
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21
software 21CFR & audit trail reports CFR & audit trail reports
on product testing.
Evaluation by PEC:
i. The formula used to calculate the assay and Firm claims that, As already mentioned in method of
dissolution is not correct. Clarification is analysis the concentration of sample & standard used
required for this regard. in the assay and dissolution is same. So, that‘s why
the peak area of standard and sample was considered
to calculate the percentage of assay and dissolution
Formula
Peak area of sample
%age = ------------------- x 100
Peak area of standard
USP Reference is provided
ii. Clarification is required, regarding inverted Firm responded that these inverted peaks or extra
peaks in assay and dissolution analysis peaks are of pure solvent peak used in the analysis
(Dissolution: e.g. Sample ID: B No. SSTAB- method provided.
005) Assay (Sample ID: B No. SSTAB- Moreover, the analytical method validation study. In
005.103.lcd) which the specificity is clarifying the solvent peaks
iii. Clarification is required, regarding variation Firm reply that, ―The difference of run time in
in run time of chromatograms in assay and dissolution profile study is due to different media used
dissolution analysis. (Dissolution is on 5.5 and during study possibility of some extra peaks may
min in chromatograms in volume 2/6) and 7 be elute. Due to this reason, run time increased to
minutes in chromatograms in volume 6/6) make sure the elution of these extra peaks if any.
That‘s why the run time increases up to one min more
in the comparative dissolution profile study. As this is
only the study of our product dissolution behavior in
different media with innovator product‖.
iv. Why baseline is not stable in comparative The comparative dissolution study is conducted in
dissolution chromatograms (e.g. in case of different pH media as recommended by the USP. The
dissolution pH 4.5). Justify column behaves differently in different medias as a
general rule. In case of Acetate buffer media pH 4.5
the base line is stable and some peaks of the media are
observed as a normal consequence. This is followed
by the distinct peak of the active Solifenacin succinate
which is reproducible in all the runs. Therefore there
is no observed deviation.
Decision: Deferred for consideration of case on its turn, as applied formulation is a Me Too product, for
which submission of stability studies are not required at present.

Pharmacological Group, Demanded Price / Pack GMP Inspection
Finished Product size Report Date &
995. M/s Highnoon Valpas 400/100 tablets Form 5D Epclusa400mg/100m
Laboratories, 17.5km, Each Film Coated Tablet Dy. No. 2009 g Tablet (Canada)
Multan Road, Lahore contains: (Duplicate dossier)
Sofosbuvir…… ….400mg 13/01/2017 Last inspection report
Velpatasvir…100 mg Fee 50000/- (Challan # Dated 27/09/2018 is
Anti-viral drug 0568772) Duplicate attached which
confirms the good
Pack Size level of GMP
14‘s tablets compliance.
Price /- per pack

Drug Valpas 400/100 tablets
Name of Manufacturer M/s Highnoon Laboratories, 17.5km, Multan Road, Lahore
Manufacturer of API Sofosbuvir (Optimus Drugs Pvt Ltd, India)
Velpatasvir (Optrix Laboratories Pvt Ltd)
API Lot No. Sofosbuvir (OP-GLD/10/17/073)
Velpatasvir (OT-VCP/002/79)
Description of Pack
Alu – Alu blister
Stability Storage Condition Real Time: 30‘C ± 2‘C / 65% ± 5%RH
Accelerated:40‘C ±2‘C / 75% ± 5%RH
Frequency Real Time:0,3,6,9, 12, 18, 24 (Months)
Accelerated: 0,3 & 6 ( Months)
Batch No. RD 18123 RD 18124 RD 18125
No. of Batches 03 batches
No.
1. COA of API Copy of COA from:
Sofosbuvir: Optimus Drugs Pvt Ltd, 1-2-11/1,
Above SBI bank st no.2,Kakatiya Nagar,
Habsiguda Hyderabad-500007, Telangana
India
Velpatasvir: Optrix Laboratories Pvt Ltd,
Survey no 147,Ramalingampally (V),

Bommalaramaram (M), Yadadri Bhuvanagirl
(D)-508126, Telangana India
2. Approval
0 of API by regulatory authority of country of Copy of GMP Certificate:
origin or GMP certificate of API manufacturer issued Sofosbuvir: (#2021/A3/2018) issued to
by regulatory authority of country of origin. Optimus Drugs Pvt Ltd, 1-2-11/1, Above SBI
bank st no.2,Kakatiya Nagar, Habsiguda
Hyderabad-500007, Telangana India issued by
drug control administration Gov of telangana
valid till 21-5-2020.
Velpatasvir: (#5109/A3/2018) issued to
Optrix Laboratories Pvt Ltd, Survey no
147,Ramalingampally (V), Bommalaramaram
(M), Yadadri Bhuvanagirl(D)-508126,
Telangana India drug control administration
Gov of telangana valid till 4-9-2020.
Yes
5. Documents confirming import of API etc. Copy of commercial invoice has been
submitted issued by ADC, DRAP.
Sofosbuvir: Import quantity: 250 kg
Reference standard: NA
Impurities: Not provided
Velpatasvir: Import quantity: 2 kg
Reference standard: NA
documents.
Yes
Yes
1978.

1. Reference of last onsite panel Last onsite inspection conducted on 1st January, 2019 for following
inspection for instant dosage products
form conducted during last two  Nebvax (Nebivolo + Valsartan) 5/80mg Tablet
years.  Daplozmet 5/850mg Tablet
 Daplozmet 5/1000mg Tablet
According to the report following important points were confirmed
1. HPLC is 21 CFR compliant
2. Audit trails of the test reports were available.
3. Related manufacturing area equipment‘s personals and

2. Documents for the procurement Sofosbuvir: The firm has submitted photocopies of ADC (Lahore)
of API with approval from attested, dated 31-10-2017, Commercial Invoice for 250 Kg via
DRAP (in case of import). Invoice # 293/EXP dated: 24-10-2017 Lot No. OP-GLD/10/17/071
from M/s. Optimus Drugs (Pvt) Ltd., India Survey No. 239 & 240,
Dothigudem (V), Pochampally (M), Yadadri – Bhuvanagiri (D),
508284, Telangana, India. vide proper approval from DRAP Office,
Lahore.
Velpatasvir: The firm has submitted photocopies of ADC (Lahore)

attested, dated 21-02-2018, Commercial Invoice for 2Kg via Invoice #
OT069/EXP dated: 25-01-2018 Lot No. OT-VCP/002/79 from M/s.
Optrix Laboratories (Pvt) Ltd., India, Survey No. 147,
Ramalingampally (V), Bommalaramaram (M), Yadadri – Bhuvanagiri
(D), Telangana, India vide proper approval from DRAP Office,
Lahore.
3. Documents for the procurement The reference standards were received free of cost with API
of reference standard and Sofosbuvir & Velpatasvir. Therefore, no separate procuring
impurity standards. documents available.
4. Approval of API/ DML/GMP Sofosbuvir copy of GMP Certificate issued on 02 January, 2017 by
certificate of API manufacturer Drugs Control Administration, Government of Telangana, India.
issued by regulatory authority of Velpatasvir copy of GMP Certificate issued on 12th July, 2017 by
country of origin. Drugs Control Administration, Government of Telangana, India.
5. Mechanism for Vendor pre- Firm has submitted Vendor Qualification Flow Chart.
qualification
6. Certificate of analysis of the  Sofosbuvir API:
API, reference standards and Photocopy of COA of Batch No. OP-GLD/10/17/073 issued by
impurity standards M/s Optimus Drugs Pvt Ltd, India is submitted.
1. Reference standards:
The firm has submitted the copy of Reference Standards
(Sofosbuvir) Batch No. OP-SFS/RS1402, provided by the API
Manufacturer - M/s Optimus Drugs Pvt Ltd, India
 Velpatasvir API:
Photocopy of COA of Batch No. OT-VCP/002/79 issued by M/s
Optrix Laboratories Pvt Ltd, India is submitted.
2. Reference standards:
The firm has submitted the copy of Reference Standards
(Velpatasvir) Batch No. OT-VCP/S1/003/01, provided by the API
Manufacturer - M/s Optrix Laboratories Pvt Ltd, India
development?
8. List of qualified staff involved in Firm has submitted list of 06 qualified person working in R&D section
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of generalized SOP with the title
the development & stability ‗Product Design & Development‘.
testing of trial batches. Effective Date: 10th April, 2017

10. Complete batch manufacturing Firm has provided complete batch manufacturing record of all the
SOFOSBUVIR - VELPATASVIR 400-100MG TABLET
BATCH BATCH MFG. MFG.
NO . SIZE STARTED COMPLETED
RD-18123 900 Tabs 06-06-2018 06-06-2018
RD-18124 900 Tabs 06-06-2018 06-06-2018
RD-18125 900 Tabs 06-06-2018 06-06-2018
of stability batches. Sofosbuvir-Velpatasvir 400-100mg Tablet; Stability Pack Size
: 4 x 7‘s)
 RD-18123: Batch Size : 900 Tablets
23 Packs placed on stability (Accelerated: 06 Packs, Real Time :
17 Packs), out of which 02 pack are remaining Accelerated and
13 Packs remaining Real Time.
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of digital data logger for temperature and
temperature and humidity humidity monitoring control for the complete stability period.
13. Method used for analysis of API Firm has provided the method used for analysis of API along with its
along with COA. certificate of analysis
14. Method used for analysis of FPP Firm has provided method used for analysis of FPP and complete
& complete record of testing of record of testing of stability batches including chromatograms, lab
stability batches (i.e. reports and raw data sheets are submitted with 06 months Accelerated
chromatograms, lab reports, raw stability data and 06 months Real Time Stability Data.
data sheets etc.)
15. Reports of stability studies of Sofosbuvir: The firm has submitted copy of Long Term 24 Months
API from manufacturer. (25°C ± 2°C & 60±5%RH) stability study reports of 03 batches of
Sofosbuvir from M/s Optimus Drugs (Pvt) Ltd., India.
Velpatasvir: The firm has submitted copy of Accelerated 03 Months
(40°C ± 2°C & 75±5%RH) and Long Term 03 Months (25°C ± 2°C
& 60±5%RH) stability study reports of 03 batches of Velpatasvir from
M/s Optrix Laboratories (Pvt) Ltd., India.
16. Analysis reports for excipients The firm has submitted copy of COAs for the excipients used in the
used. applied formulation.
17. Drug-excipients compatibility The firm has submitted Drug-excipients compatibility studies
studies.

dissolution data. product EpclusaTM 400mg/100mg Tablet, Patheon Inc. Mississauga,
ON L5N 7K9 Canada.
REFERENCE P RODUCT OF
F EATURE
P RODUCT HIGHNOON
B RAND EpclusaT M 400/100mg Sofosbuvir–
NAME Tablet Velpatasvir
400/100mg Tablets
B ATCH NO. YPPGD3 RD-18124
MFG. / Mfg. Date: 07-2017 Mfg. Date: 06-2018
EXPIRY Exp. Date: 07-2020 Exp. Date: 06-2020
DATE
Test was performed at:
i. 1.2N Hydrochloric Acid Solution
software 21CFR & audit trail audit trail reports.
Evaluation by PEC:
S# Short comings Response of Firm

1. COA of impurity standards are The related substance in API and FPP are evaluated by the
required validated method provided by API manufacturer (Optimus
drug pvt Ltd). In this method the related substance (RP
isomers) are calculated by area normalization method
which does not required impurity standard. For
identification of known impurity (RP isomer) the relative
retention time of the impurity are used. The relative
retention time of impurity is about 0.95 with reference to
sofosbuvir retention time.
2. Valid GMP certificate is required as Valid GMP certificate of Sofosbuvir: (# 2021/A3/2018)
Photocopy of GMP Certificate issued to Optimus Drugs Pvt Ltd, valid up to 21-5-2020 is
Sofosbuvir: (# 11980/A3/2016) issued provided.
to Optimus Drugs Pvt Ltd, was valid
up to 1-2019.
3. Valid GMP certificate is required as Valid GMP certificate of Velpatasvir: (#5109/A3/2018)
Photocopy of GMP Certificate issued to Optimus Drugs Pvt Ltd, valid up to 4-9-2020 is
Velpatasvir: (#8340/A3/2017) issued provided.
by Optrix Laboratories Pvt Ltd, was
valid up to 7-2018.
4. The innovators finish product testing The microbiological testing is not performed on trial
including tests for microbial contents. batches the first three commercial validation batches will
Justify the exemption of these tests be subject to microbiology testing and subsequently every
5th commercial batch of solid dosage form will be tested
5. Stability studies reports on conditions For API: The firm has submitted copy Long Term 03
of Zone IV-A for API conducted by Months (25°C ± 2°C & 60±5%RH) stability study reports
API manufacturer is required. of 03 batches
On query they submitted that according to WHO technical
report series Regarding real time stability study storage
conditions for long term stability study is 25°C ± 2°C /
60% ± 5% RH or 30°C ± 2°C / 65% ± 5% RH ―which is
determined by the climatic condition under which API is
intended to be stored‖.
ICH guideline also supported that statement that ―therefore
the climatic conditions for long term stability study can be
selected based on the intended storage conditions of the

API.
Manufacturer recommended the storage of valpatesvir API
at 25°C ± 2°C / 60% ± 5% RH and at highnoon the raw
material store is maintained at 25°C ± 2°C / 60% ± 5% RH
therefore we request you to accept the stability at 25°C ±
2°C / 60% ± 5% RH
Decision: Registration Board decided to defer the case for submission of complete stability studies for
three batches of API either as per zone IV-A conditions as only copy of Long Term 03 Months (25°C ±
2°C & 60±5%RH) stability study reports of 03 batches are submitted OR Justification on scientific basis
that whether an API with stability studies at (250C ±20C & 60 ±5% RH.) be used to prepare a FPP
which has to be stored at zone IV-A conditions.
Finished Product Specification Pack size Report Date &
Remarks
996. M/s Highnoon Sacuva 50 mg tablets Form 5D Entresto
Laboratories, 17.5km, Dy. No. 384 (FDA)
Multan Road, Lahore Each Film Coated Tablet 10/11/2016
contains: Fee 50000/- (challan Last inspection report
Sacubitril ….24 mg # 0568768) Dated 27/09/2018 is
Valsartan …..26mg 07/11/2016 attached which
Angiotensin II Receptor Pack Size confirms the good
Blockers 14‘s, 20‘s,30‘s, 60‘s level of GMP
tablets compliance.
Price /- per pack

Drug Sacuva 50 mg
Manufacturer of API (Sacubitril/Valsartan) Zhuhai Rundu Pharmaceutical Co. Ltd China No.6,
North Airport Road, Sanzao Town, Jinwan District, Guangdong, China
API Lot No. 57317060103
Description of Pack
Alu – Alu blister
Time Period Real Time: 24 Months (9 month data provided)
Batch No. RD 18002 RD 18003 RD 18004
Date of Initiation 03/18 03/18 03/18

No.
1. COA of API Copy of COA from M/s Zhuhai Rundu
Pharmaceutical Co. Ltd China No.6, North
Airport Road, Sanzao Town, Jinwan District,
Guangdong, China submitted.
2. Approval
0 of API by regulatory authority of country of Copy of GMP Certificate (# GD20160649)
origin or GMP certificate of API manufacturer issued by issued by China Food and Drug
regulatory authority of country of origin. Administration People‘s Republic of China is
submitted valid till 2021.
Yes
details of tests.
Reference standard: 50 mg #170801
Working standard: 100 mg
Batch #: 18-WS-04
Yes
Yes
ii. Risk assessment report of sacubitril/valsartan is provided about NDMA
iii. Stability Study of API is on 25 C and 30 both
iv. Detection at 254. With 8 minutes time Check it with protocol
v. Check protocol according to USFDA dissolution or not?
vi. Some of the excipient are different from innovator e.g. innovators is using copovidone
form conducted during last  Nebvax (Nebivolo + Valsartan) 5/80mg Tablet
two years.  Daplozmet 5/850mg Tablet

6. Related manufacturing area equipment‘s personals and utilities

2. Documents for the The firm has submitted photocopies of ADC (Lahore) attested, dated 19-
procurement of API with 10-2017, Commercial Invoice for 2Kg via Invoice # RIS17079 dated: 28-
approval from DRAP (in case 09-2017 Lot No. 57317060103 from M/s. Zhuhai Rundu Pharmaceutical
of import). Co. Ltd China No.6, North Airport Road, Sanzao Town, Jinwan District,
Guangdong, China vide proper approval from DRAP Office, Lahore
3. Documents for the The reference standards were received free of cost with API
procurement of reference Secubitril/Valsartan. Therefore, no separate procuring documents
standard and impurity available.
standards. Reference standard: 50 mg #170801
Batch #: 18-WS-04
4. Approval of API/ DML/GMP Copy of GMP Certificate (# GD20160649) issued by China Food and
certificate of API Drug Administration People‘s Republic of China is submitted valid till
manufacturer issued by 2021
regulatory authority of
country of origin.
qualification
6. Certificate of analysis of the  Sacubitril / Valsartan API:
API, reference standards and Photocopy of COA of Batch No. 57317060103 issued by M/s Zhuhai
impurity standards Rundu Pharmaceutical Co., Ltd., China is submitted.
Reference standards:
The firm has submitted the copy of Reference Standards (Sacubitril
& Valsartan) Batch No. 170801, provided by the API Manufacturer -
M/s Zhuhai Rundu Pharmaceutical Co., Ltd., China
8. List of qualified staff Firm has submitted list of 06 qualified person working in R&D section
involved in product
experience.
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of generalized SOP with the title ‗Product
the development & stability Design & Development‘.
stability batches. Sacuva 50mg Tablets
MFG. MFG.
B ATCH NO. B ACH SIZE
STARTED COMPLETED
RD-18002 3,000 Tabs 09-01-2018 12-01-2018
RD-18003 3,000 Tabs 09-01-2018 12-01-2018
RD-18024 3,000 Tabs 29-01-2018 05-02-2018
quantities of stability batches. Sacuva 50mg Tablets; Stability Pack Size : 2 x 10‘s)
19 Packs placed on stability (Accelerated: 05 Packs, Real Time : 14
Packs), out of which 01 pack are remaining Accelerated and 07
Packs remaining Real Time.

QA/QC DATA
for temperature and humidity humidity monitoring control for the complete stability period.
monitoring of stability
accelerated)
testing of stability batches raw data sheets are submitted with 06 months Accelerated stability data
(i.e. chromatograms, lab and 09 months Real Time Stability Data.
15. Reports of stability studies of SACUBITRIL: The firm has submitted copy of Accelerated 06 Months
API from manufacturer. (40°C ± 2°C & 75±5%RH), Long Term 12 Months (25°C ± 2°C &
60±5%RH) and Intermediate 12 Months (30°C ± 2°C & 75±5%RH) &
stability study reports of 03 batches of Sacubitril/Valsartan from M/s
Zhuhai Rundu Pharmaceutical Co., Ltd., China
16. Analysis reports for The firm has submitted copy of COAs for the excipients used in the
excipients used. applied formulation.
studies.
dissolution data. product Entresto 50mg Tablet, Novertis Pharma, Switzerland.
F EATURE
P RODUCT HIGHNOON
BRAND NAME Entresto 50mg Tabs Sacuva 50mg Tabs
BATCH NO. TN690 RD-18024
MFG. / EXPIRY Mfg. Date: 12-2017 Mfg. Date: 01-2018
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR & audit
software 21CFR & audit trail trail reports.
Evaluation by PEC:
 The firm has submitted copy of generalized SOP with the title ‗Product Design &
Development‘.Provide complete stability protocols along with detail protocols of dissolution method and assay
methods.
 Why on stability 24.3 and 25.7 is mentioned but reference is of 24 ad 26
 In protocol batch number is mentioned as 18024 but in protocol its 8005?
 Impurity standard details?
 Reference of last onsite panel inspection for instant dosage form conducted during last two years
1. Provide complete stability protocols The stability and report have been submitted
along with detail protocols of trail
batches and testing methods e.g.
dissolution method and assay
methods.
2. COA and import documents of The related substance in API and FPP are evaluated by the

impurity standards are required validated method provided by API manufacturer Zuhai
Rundu pharmaceuticals co Ltd. In this method the related
substance are calculated by area normalization method
which does not required impurity standard. For
identification of impurity the relative retention time of the
impurity are used. The relative retention time of impurity B
is about 0.7 and impurity C is about 5 with reference to
valsartan retention time (6 min)
3. Some of the excipient are different Firm replied that they are also using Co-povidone by the
from innovator e.g. innovators is name of Kollidone VA 64
using copovidone which is not used in
applied product. Clarification is
needed.
4. Reference to approval of one (01) Last onsite inspection conducted on 1st January, 2019 for
similar dosage form by Registration following products
Board on the basis of which you are  Nebvax (Nebivolo + Valsartan) 5/80mg Tablet
claiming exemption from verification  Daplozmet 5/850mg Tablet
of authenticity of submitted stability  Daplozmet 5/1000mg Tablet
data
According to the report following important points were
confirmed
Related manufacturing area equipment‘s personals and
Decision: Registration Board decided to approve registration of ―Sacuva 50 mg tablets (Sacubitril 24 mg,
Valsartan …..26mg) by M/s M/s Highnoon Laboratories, Lahore,. Manufacturer will place first three

Pharmacological Group, Demanded Price / Report Date &
Finished Product Specification Pack size Remarks
Laboratories, Dy. No. 385 (FDA)
17.5km, Multan Each Film Coated Tablet 10/11/2016
Road, Lahore contains: Fee 50000/- Last inspection report
Sacubitril ….49mg (#0568770) Dated 27/09/2018 is
confirms the good
Angiotensin II Receptor Pack Size level of GMP
Blockers 14‘s tablets compliance.
Price /- per pack

Drug Sacuva 100 mg
API Lot No. 57317060103
Description of Pack Alu – Alu blister
Batch No. RD 18005 RD 18006 RD 18043
No.
2. Approval
submitted valid till 2021
Yes
details of tests.
Batch #: 18-WS-04
Yes
Yes
vii. Risk assessment report of sacubitril/valsartan is provided about NDMA
viii. Stability Study of API is on 25 oC and 30 both
ix. Detection at 254. With 8 minutes time Check it with protocol
x. Check protocol according to USFDA dissolution or not?
xi. Some of the excipient are different from innovator e.g. innovators is using copovidone

Guangdong, China vide proper approval from DRAP Office, Lahore.
standards.
country of origin.
qualification
involved in product
experience.
Production Data
MFG. MFG.
STARTED COMPLETED
RD-18005 1,500 Tabs 18-01-2018 22-01-2018

RD-18006 1,500 Tabs 18-01-2018 23-01-2018
RD-18043 1,500 Tabs 29-01-2018 12-02-2018
QA/QC DATA
accelerated)
studies.
dissolution data. product Entresto 100mg Tablet, Novertis Pharma, Switzerland
F EATURE
P RODUCT HIGHNOON
BRAND NAME Entresto 100mg Tabs Sacuva 100mg Tabs
BATCH NO. TP182 RD-18043
MFG. / EXPIRY DATE Mfg. Date: 12-2017 Mfg. Date: 01-2018
Exp. Date: 11-2019 Exp. Date: 01-2020
Evaluation by PEC:
 Provide complete stability protocols along with detail protocols of dissolution method and assay methods.
 In protocol batch number is mentioned as 18024 but in protocol its 8005.

1. Provide complete stability protocols The stability and report have been submitted
along with detail protocols of trail
batches and testing methods e.g.
dissolution method and assay methods.
2. COA and import documents of impurity The related substance in API and FPP are evaluated by
standards are required the validated method provided by API manufacturer
Zuhai Rundu pharmaceuticals co ltd.In this method the
related substance are calculated by area normalization
method which does not required impurity standard. For
identification of impurity the relative retention time of
the impurity are used. The relative retention time of
impurity B is about 0.7 and impurity C is about 5 with
reference to valsartan retention time (6 min)
3. Some of the excipient are different from Firm replied that they are also using Copovidoneby the
innovator e.g. innovators is using name of Kollidone VA 64
copovidone which is not used in applied
product. Clarification is needed.
4. Reference to approval of one (01) similar Last onsite inspection conducted on 1st January, 2019
dosage form by Registration Board on for following products
the basis of which you are claiming  Nebvax (Nebivolo + Valsartan) 5/80mg Tablet
exemption from verification of  Daplozmet 5/850mg Tablet
authenticity of submitted stability data  Daplozmet 5/1000mg Tablet

confirmed

Valsartan 51mg) by M/s Highnoon Laboratories, Lahore,. Manufacturer will place first three production
batches of the product on long term stability studies throughout proposed shelf life and on accelerated

No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Availability / Local
Applicant Form + Strength), Date, Fee (including Availability
Laboratories, Dy. No. 383 (FDA)
17.5km, Multan Each Film Coated Tablet 10/11/2016
Road, Lahore contains: Fee 50000/- Last inspection report
Sacubitril ….97mg (#0568769) Dated 27/09/2018 is
confirms the good
Angiotensin II Receptor Pack Size level of GMP
Blockers 14‘s tablets compliance.
Price /- per pack

Drug Sacuva 200 mg
API Lot No. 57317060103
Description of Pack
Alu – Alu blister
Accelerated: 0,3 & 6 (Months)
Batch No. RD 18008 RD 18009 RD 18044
No.
2. Approval
submitted valid till 2021
Yes
details of tests.
Batch #: 18-WS-04
Yes
Yes

i. Risk assessment report of sacubitril/valsartan is provided about NDMA
ii. Stability Study of API is on 25 oC and 30 both
iii. Detection at 254. With 8 minutes time Check it with protocol
iv. protocol according to USFDA
v. Some of the excipient are different from innovator e.g. innovators is using copovidone

Guangdong, China vide proper approval from DRAP Office, Lahore.
standards.
country of origin.
qualification
involved in product
experience.

Production Data
MFG. MFG.
STARTED COMPLETED
RD-18008 750 Tabs 18-01-2018 23-01-2018
RD-18009 750 Tabs 18-01-2018 23-01-2018
RD-18044 750 Tabs 29-01-2018 12-02-2018
QA/QC DATA
accelerated)
studies.
dissolution data. product Entresto 200mg Tablet, Novertis Pharma, Switzerland.
F EATURE
P RODUCT HIGHNOON
B RAND NAME Entresto 200mg Tabs Sacuva 200mg Tabs

B ATCH NO. TN272 RD-18044
MFG. / EXPIRY Mfg. Date: 12-2017 Mfg. Date: 01-2018
Evaluation by PEC:
 Provide complete stability protocols along with detail protocols of dissolution method and assay
methods.
S Short comings Response of Firm
#
1. Provide complete stability protocols along The stability and report have been submitted
with detail protocols of trail batches and
testing methods e.g. dissolution method and
assay methods.
2. COA and import documents of impurity The related substance in API and FPP are evaluated by
standards are required the validated method provided by API manufacturer
Zuhai Rundu pharmaceuticals co ltd.In this method the
related substance are calculated by area normalization
method which does not required impurity standard. For
identification of impurity the relative retention time of
the impurity are used. The relative retention time of
impurity B is about 0.7 and impurity C is about 5 with
reference to valsartan retention time (6 min)
3. Some of the excipient are different from Firm replied that they are also using Copovidoneby the
innovator e.g. innovators is using copovidone name of Kollidone VA 64
which is not used in applied product.
Clarification is needed.
4. Reference to approval of one (01) similar Last onsite inspection conducted on 1st January, 2019
dosage form by Registration Board on the for following products
basis of which you are claiming exemption  Nebvax (Nebivolo + Valsartan) 5/80mg Tablet
from verification of authenticity of submitted  Daplozmet 5/850mg Tablet
stability data  Daplozmet 5/1000mg Tablet

confirmed
Valsartan …..103mg) by M/s M/s Highnoon Laboratories, Lahore,. Manufacturer will place first three

999. M/s Crystolite Dasone 5% gel Form-5-D ACZONE of Aqua
Pharmaceuticals, Each g of gel contains: Dy. No: 910 Pharma (USFDA)
plot #1 & 2, Street Dapsone……5% w/w Dated: 11-4-16 Last inspection was
S-2, National (Anti-Infective) Rs.50,000/- conducted on 17-10-
Industrial Zone, In-house Specifications (8/4/2016) 2017 concluding good
Rawat, Islamabad. (Challan # 0532804) compliance
As per SRO

Drug Dasone 5% gel
Name of Manufacturer M/s Crystolite Pharmaceuticals, plot #1 & 2, Street S-2, National Industrial Zone,
Rawat, Islamabad.
Manufacturer of API Dapsone: M/S Chongqing Huapont shengchem Pharma. co. Ltd. No. 666, Rongjun
road, Nanjin Avenue, Hechuandistrict Chongqing, China
API Lot No. Dapsone: DAP-20170701
Description of Pack
15 gm and 30 gm plastic tube
Frequency Accelerated: 0, 3,6 (month) Real Time: 0, 3,6, 9 (month)
Batch No. 034T17 035T17 036T17

Batch Size 0.6 kg (60 packs) 0.6 kg (60 packs) 0.6 kg (60 packs)

No. of Batches 03
1. COA of API Copy of COA from Chongqing Huapont
shengchem Pharma. co. Ltd. No. 666, Rongjun
road, Nanjin Avenue, Hechuandistrict
Chongqing, China submitted.
2. Approval
0 of API by regulatory authority of country of Copy of GMP Certificate issued by Chongqing
origin or GMP certificate of API manufacturer issued (City) Food and Drug Administration People‘s
by regulatory authority of country of origin. Republic of China is submitted valid till 2020.
Yes

5. Documents confirming import of API etc. Dapsone:
Copy of commercial invoice has been submitted
issued by ADC, Islamabad DRAP.
Import quantity: 400 g
Batch #: DAP-WS-20170514
documents.
Yes

inspection for instant dosage form ―Halovate cream, lotion, ointment‖ (Halobetasol) and Plaiglo
conducted during last two years. cream which was conducted on 22-August 2017 and was
presented in 271th meeting of Registration board. Registration
Board decided to approve registration. According to the report
2. Documents for the procurement of The firm has submitted photocopies of ADC (Islamabad) attested
API with approval from DRAP (in Commercial Invoice for 400gm via Invoice # HP2017914 dated:
case of import). 14/09/2017 lot No. DAP-20170701 from Chongqing Huapont
shengchem Pharma. co. Ltd. No. 666, Rongjun road, Nanjin
Avenue, Hechuandistrict Chongqing, Chinavide proper approval
from DRAP Office, Islamabad.
reference standard and impurity with API. Therefore no procuring documents available. But
standards. undertaking from Chongqing Huapont Pharmaceuticals co Ltd is
provided that sample is provided along with API
4. Approval of API/ DML/GMP Copy of GMP Certificate issued by Chongqing Food and Drug
certificate of API manufacturer Administration People‘s Republic of China is submitted valid till
issued by regulatory authority of 2020. (Certificate # CQ20150003)
country of origin.
5. Mechanism for Vendor pre- Firm has submitted SOPs for vendor evaluation and performance
qualification monitoring
6. Certificate of analysis of the API,  Dapsone API:
reference standards and impurity Photocopy of COA of Batch No. DAP-20170701 issued by
standards Chongqing Huapont shengchem Pharma. co. Ltd. Chongqing,
China is submitted.
The firm has submitted the copy of Working Standard (Batch
# DAP-WS-20170514), Reference Standard and impurity
standards of API were not provided
7. Documents for the procurement of Firm has submitted documents for procurement of excipients used
development?
8. List of qualified staff involved in Firm has submitted list of 6 qualified person, 3working in R&D
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP for stability
development & stability testing of studies and product development protocols.
trial batches.
Batch No. Bach size Mfg. Started
034T17 0.6 kg (60 packs) 10- 2017
035T17 0.6 kg (60 packs) 10- 2017
036T17 0.6 kg (60 packs) 10- 2017
stability batches. Dapsone 5% gel ; Batch #: 034T17
Stability Pack Size : 35 packs
Remaining Packs after 9 months of real time stability: 17 packs
Remaining Packs after 6 months of accelerated stability: 3 packs
Batch #: 035T17
Batch #: 036T17
QA/QC DATA
temperature and humidity monitoring and humidity monitoring control for the complete stability period.
accelerated)
13. Method used for analysis of API Firm has provided the method used for analysis of API along with
along with COA. its certificate of analysis
complete record of testing of stability record of testing of stability batches including chromatograms, lab
batches (i.e. chromatograms, lab reports and raw data sheets are submitted with 06 months stability
reports, raw data sheets etc.) data (Accelerated). & 9 months real Time
15. Reports of stability studies of API Dapsone: The firm has submitted copy of accelerated, 06
from manufacturer. Months (40°C ± 2°C & 75±5%RH) , long term, 36 Months
(30°C ± 2°C & 75±5%RH),& stability study reports of 03 batches
of Dapsone from Chongqing Huapont shengchem Pharma. co.
Ltd. Chongqing, China
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients used in
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility studies
studies. and has referred to the Innovator Product
18. Record of comparative dissolution Firm claims that as it‘s a gel dosage form comparative studies
data. is not needed
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR
software 21CFR & audit trail reports & audit trail reports
on product testing.
Evaluation by PEC:
Deficiency/Observation Response by Pharma.
The firm do not submitted the copy of Working standard COA was submitted, other are still
Working Standards, Reference Standard and needed.
impurity standards of API provided by the
API Manufacturer
Firm has not submitted SOPs for vendor Provided
evaluation and performance monitoring
Drug-excipients compatibility studies. Firm has not submitted Drug-excipients compatibility
studies & has referred to Innovator Product.
Evidence of fee of 50,000/- Provided
Description of Pack Provided
GMP certificate is of city not province Copy of GMP Certificate issued by Chongqing (City)
Food and Drug Administration People‘s Republic of
China is submitted valid till 2020 is again submitted
Decision: Registration Board decided to approve registration of ―Dasone 5% gel by M/s Crystolite
Pharmaceuticals, Islamabad, and Manufacturer will place first three production batches of the product
on long term stability studies throughout proposed shelf life and o n accelerated studies for six months.
1000. M/s Crystolite Dasone 7.5 % gel Form-5-D ACZONE of Aqua
Pharmaceuticals, Each g of gel contains: Dy. No: 909 Pharma (USFDA)
plot #1 & 2, Street Dapsone……7.5% w/w Dated: 11-4-2016
S-2, National (Anti-Infective) Rs.50,000/- Last inspection was
Industrial Zone, In-house Specifications (8/4/2016) conducted on 17-10-
Rawat, Islamabad. (Challan # 0532805) 2017 concluding good
compliance

Drug Dasone 7.5% gel
Name of Manufacturer M/s Crystolite Pharmaceuticals, plot #1 & 2, Street S-2, National Industrial Zone,
Rawat, and Islamabad.
Manufacturer of API Dapsone: M/S Chongqing Huapont shengchem Pharma. co. Ltd. No. 666, Rongjun
road, Nanjin Avenue, Hechuandistrict Chongqing, China
API Lot No. Dapsone: DAP-20170701
Description of Pack
15 gm and 30 gm plastic tube
Frequency Accelerated: 0, 3,6 (month) Real Time: 0, 3,6, 9 (month)
Batch No. 034T17 035T17 036T17
Batch Size 0.6 kg (60 packs) 0.6 kg (60 packs) 0.6 kg (60 packs)

No. of Batches 03
1. COA of API Copy of COA from Chongqing Huapont
shengchem Pharma. co. Ltd. No. 666, Rongjun
road, Nanjin Avenue, Hechuandistrict
Chongqing, China submitted has different batch
number then the batch number on commercial
invoice.
2. Approval
0 of API by regulatory authority of country of Copy of GMP Certificate issued by Chongqing
origin or GMP certificate of API manufacturer issued Food and Drug Administration People‘s
by regulatory authority of country of origin. Republic of China is submitted valid till 2020.
Yes
5. Documents confirming import of API etc. Dapsone: Copy of commercial invoice has been
submitted issued by ADC, Islamabad DRAP.
Import quantity: 400 g
Batch #: DAP-WS-20170514
documents.
Yes
i. Comparative Dissolution in: pH 1.2 HCl solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer
solution
ii. Calculations of F2 Value is missing in comparative dissolution
iii. Impurities details provided ( valsartan B C, COA provided)
iv. Detection at 254 nm
v. Run time: 15 min
vi. The test performed are pH, physical appearance, identification and assay by HPLC (50 volume of
acetonitrile and 50 of water) a max (254 m),column 250x4.6 mm and flow rate is 1 ml/min
inspection for instant dosage form ―Halovate cream, lotion, ointment‖ (Halobetasol) and Plaiglo
conducted during last two years. cream which was conducted on 22-August 2017 and was
presented in 271th meeting of Registration board. Registration
Board decided to approve registration. According to the report
2. Documents for the procurement of The firm has submitted photocopies of ADC (Islamabad) attested
API with approval from DRAP (in Commercial Invoice for 400gm via Invoice # HP2017914 dated:
case of import). 14/09/2017 lot No. DAP-20170701 from Chongqing Huapont
shengchem Pharma. co. Ltd. No. 666, Rongjun road, Nanjin
Avenue, Hechuandistrict Chongqing, Chinavide proper approval
from DRAP Office, Islamabad.
reference standard and impurity with API. Therefore no procuring documents available. But
standards. undertaking from Chongqing Huapont Pharmaceuticals co Ltd is
provided that sample is provided along with API
4. Approval of API/ DML/GMP Copy of GMP Certificate issued by Chongqing Food and Drug
certificate of API manufacturer Administration People‘s Republic of China is submitted valid till
issued by regulatory authority of 2020.
country of origin.
5. Mechanism for Vendor pre- Firm has submitted SOPs for vendor evaluation and performance
qualification monitoring
6. Certificate of analysis of the API,  Dapsone API:
reference standards and impurity Photocopy of COA of Batch No. DAP-20170701 issued by
standards Chongqing Huapont shengchem Pharma. co. Ltd. Chongqing,
China is submitted.
The firm submitted the copy of Working Standards, But
Reference Standard and impurity standards of API is not
provided
7. Documents for procurement of Firm has submitted documents for procurement of excipients used
development?
8. List of qualified staff involved in Firm has submitted list of 6 qualified person, 3working in R&D
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP for stability
development & stability testing of studies and product development protocols.
trial batches.
037T17 0.6 kg (60 packs) 15-12- 2017
038T17 0.6 kg (60 packs) 15-12- 2017
039T17 0.6 kg (60 packs) 15-12- 2017
stability batches. Dapsone 7.5% gel ; Batch #: 037T17
Batch #: 038T17
Batch #: 039T17
QA/QC DATA
temperature and humidity monitoring and humidity monitoring control for the complete stability period.
accelerated)
13. Method used for analysis of API Firm has provided the method used for analysis of API along with
along with COA. its certificate of analysis
complete record of testing of stability record of testing of stability batches including chromatograms, lab
batches (i.e. chromatograms, lab reports and raw data sheets are submitted with 06 months stability
reports, raw data sheets etc.) data (Accelerated). & 9 months real Time
15. Reports of stability studies of API Dapsone: The firm has submitted copy of accelerated, 06
from manufacturer. Months (40°C ± 2°C & 75±5%RH) , long term, 36 Months
(30°C ± 2°C & 75±5%RH),& stability study reports of 03 batches
of Dapsone from Chongqing Huapont shengchem Pharma. co.
Ltd. Chongqing, China
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients used in
17. Drug-excipients compatibility The firm has not submitted Drug-excipients compatibility studies
studies. and has referred to the Innovator Product
18. Record of comparative dissolution Firm claims that as it‘s a gel dosage form comparative studies is
data. not needed
19. Compliance Record of HPLC Firm has submitted compliance record of HPLC software 21 CFR
software 21CFR & audit trail reports & audit trail reports
on product testing.
Evaluation by PEC:
The firm do not submitted the copy of Working Working standard COA was submitted, other
Standards, Reference Standard and impurity are still needed.
standards of API provided by the API Manufacturer
Firm has not submitted SOPs for vendor evaluation Provided
and performance monitoring
Drug-excipients compatibility studies. The firm has not submitted Drug-excipients
compatibility studies and has referred to the
Innovator Product
Evidence of fee of 50,000/- Provided
Description of Pack Provided
Decision: Registration Board decided to approve registration of ―Dasone 7.5% gel by M/s Crystolite
Pharmaceuticals, Islamabad, and Manufacturer will place first three production batches of the product
on long term stability studies throughout proposed shelf life and on accelerated studies for six months.

No. Manufacturer / (Proprietary Name + Dosage Form + Initial Diary & Availability / Local
Applicant Strength), Composition, Date, Fee (including Availability
Pack size Remarks
1001. M/ s Dyson Esonap 20/500 Tablet Form 5 Vimovo Tablet
Research Each coated tablet contains: Dairy No. Duplicate 20/500 by Horizone
Laboratories (Pvt.) Naproxen…….500 mg dossier Pharma USA
Ltd. 28th KM Esomperazole (as Meagnesium) Dated 4-2-2019.
Ferozpur Road, ........20 mg Rs.8000/- Panel inspection
Lahore. (Duplicate) conducted on 08-12-
Anti-inflammatory and Anti- Dated 25-May-2011 2018 recommended
rheumatic 12000 absent for grant of
Manufacturer‘s Specifications. GMPcertificate.

Drug Esonap 500/20 mg Tablet
Name of Manufacturer M/ s Dyson Research Laboratories (Pvt.) Ltd. 28th KM Ferozpur Road, Lahore.
Manufacturer of API Naproxen: M/S Zhejiang Tianxin pharmaceutical co., Ltd No 215 Fengze road,
Tiantai Zheiang 317200, China
Esomeprazole as magnesium trihydrate: M/s Everest Organics Ltd. Aroor
Village, Sadasivpet Mandal, Medak District – 502291 Telangana India
API Lot No. Naproxen: NX1611329
Esomeprazole: ESM/E-326/16
Description of Pack
Alu / Alu Blister Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 1, 2,3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. Trial#03 Trial#04 Trial#05

No. of Batches 03
Date of Submission 4872 (4/2/2019)

No.
1. COA of API Yes

2. Approval
0 of API by regulatory authority of country of Naproxen: Copy of GMP certificate
origin or GMP certificate of API manufacturer issued by (Certificate No. ZJ20170020) for M/S
regulatory authority of country of origin. Zhejiang Tianxin Pharmaceutical
corporation Limited China issued by
Zheijang province Food & Drug
Administration, valid upto 3/28/2022.
Esomeprazole: Copy of GMP certificate
(Certificate No. ZJ20170020) for M/s
Everest Organics Ltd. Aroor Village,
Sadasivpet Mandal, Medak District –
502291 Telangana India issued by
Zheijang province Food & Drug
Administration, valid up to 3/28/2022.
Yes
details of tests.
sheets etc.
5. Documents confirming import of API etc. Firm has submitted following:
•Copy of form 3 confirming license to
import of API‘s
•Copy of form 7 (Batch Certification)
•ADC attested copy of commercial invoice
stamp) for ensuring authenticity of data / documents. Yes

Yes
 Dissolution was according to USFDA. Details are as under
Dissolution 1 (naproxen at core), Dissolution 2 (naproxen at coating stage),Dissolution 3 (esomeprazole at
coating stage)
1. Reference of last onsite panel Firm has referred to onsite inspection report of their products
inspection for instant dosage Daclavir Tablet 30 & 60 mg (Daclatasvir as Dihydrochloride),
form conducted during last two Ledipasvir + Sofosbuvir and Sofosbuvir Tablets which was
years. conducted on 06th February, 2018 and was presented in 279th
meeting of Registration Board held on 29-31st January, 2018.
2. Documents for the procurement Firm has submitted following:
of API with approval from  Permission letter for import of API Vide Ref No.
DRAP (in case of import). 12494/2016/DRAP (A-IV)
Quantity: Naproxen: 6.562 kg, Esomeprazole: 334.5 gm
 Copy of form 3 confirming license to import of API‘s
 Copy of form 7 (Batch Certification)
 ADC (Lahore) attested copy of commercial invoice
3. Documents for the procurement Esomeprazole: Firm has submitted copy of invoice for the
of reference standard and Purchase of reference standard & Impurity standard i-e 100 mg
impurity standards. Omeprazole Sulphone ( Impurity-D) & Omeprazole N-Oxide
(Impurity-E)
Naproxen: Firm has submitted exemption of submission of

procurement of impurity standard of naproxen s they claim that API
manufacturer claim no impurity in there COA as per USP.
4. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate

certificate of API manufacturer Esomeprazole Magnesium Trihydrate:
issued by regulatory authority of Everest Organic limited
country of origin. Certificate No. L.Dis.No.3600/E(S)/TS/2018
Dated 30-06-2018
Issued by: Drugs control Administration Government of Telangana,
India.
Naproxen Base:
Zheijiang Tianxin pharma
Certificate # No. ZJ20140007
Dated 27-01-2014
Issued by: State Food and Drug Administration China
5. Mechanism for Vendor pre- Firm has submitted copy of vendor evaluation documents form and
qualification vendor evaluation report
6. Certificate of analysis of the Esomeprazole Magnesium Trihydrate:
API, reference standards and Firm has submitted COA of API and reference standard and impurity
impurity standards standards (Impurity D and E)
Naproxen: Firm has submitted COA of API
reference standard missing
Impurity: Firm submitted exemption of submission of
procurement of impurity standard as they claim that API
manufacturer claim no impurity in there COA as per USP.
7. Documents for the procurement Firm has submitted documents for procurement of excipients.
of excipients used in product
development?
8. List of qualified staff involved in Technical staff (6 person) list including R&D was provided by firm.
Production Data
9. Authorized Protocols/SOP for Firm has submitted authorized protocols/SOPs for the development
the development & stability & testing of trial batches.
testing of trial batches.
10. Complete batch manufacturing Firm has provided Batch Manufacturing Record for all three batches
record of three stability batches.
11. Record of remaining quantities T03: 540 Tablets (70 Acc, 470 Real Time)
of stability batches. T04: 530 Tablets (60 Acc, 470 Real Time)
T05: 530 Tablets (60 Acc, 470 Real Time)
QA/QC DATA
12. Record of Digital data logger for Firm has submitted record of Digital data logger for temperature and
temperature and humidity humidity monitoring of temperature and humidity monitoring of
monitoring of stability chambers stability, stability chambers (real time and Chambers (real time and
(real time and accelerated) accelerated)
13. Method used for analysis of API Firm has submitted COA and method of analysis of API
along with COA.
14. Method used for analysis of FPP Firm has submitted method of analysis of FPP and complete record
& complete record of testing of of testing of stability complete record of testing of stability batches
stability batches (i.e. along batches (i.e. chromatograms, lab reports, with chromatograms,
chromatograms, lab reports, raw lab reports, raw data sheets etc.)
data sheets etc.)
15. Reports of stability studies of Esomeprazole:
API from manufacturer. Firm has submitted both accelerated (40°C ± 2°C &75±5%RH)
stability studies & long term (30°C ± 2°C & 65±5%RH) stability
studies reports of three batches
Naproxen:
Firm has submitted both accelerated (40°C ± 2°C &75±5%RH)
stability studies & long term (25°C ± 2°C & 65±5%RH) stability
studies reports of three batches
16. Analysis reports for excipients Form has provided COA and testing reports of excipients used
used.
17. Drug-excipients compatibility Firm has used the same excipients as that used by innovator Firm has
studies. conducted compatibility study of drug-excipients using FTIR spectra.
18. Record of comparative
dissolution data. Comparative dissolution with innovator was performed and record
was available.
19. Compliance Record of HPLC Firm has 21CFR compliant software installed on HPLC 20-A
software 21CFR & audit trail Schimadzu
Evaluation by PEC:
i. Clarification regarding exemption of

Naproxen API manufacturer complies specification of
submission of procurement of impurity
both USP and BP as per COA. So as per USP
standard of naproxen on the base of the
specification there are no impurities as mentioned in
claim that API manufacturer claim no
the COA. We also followed USP specifications
impurity in there COA as per USP but the
containing no impurities. COA of Naproxen is
provided COA mentioned two impurities
provided
i.e. impurity O, L
ii. Certificate of analysis of the Naproxen, CAO of Naproxen reference standard is provided and
reference standards prove of its we received RS along with the API so there is no
procurement separate invoice of it.
iii. USP and API manufacturer performs USP performs assay by titration method, reference. In
naproxen API, assay with HPLC Justify the COA of Naproxen API, manufacturer did not mention
use of titration method for testing of API HPLC method of assay. (Note: Testing of Naproxen
by applicant. by manufacturer on HPLC does not make firm bound
to adopt the same because questioned article is a USP
monograph).
iv. API stability of naproxen at conditions of Provided.
zone IV-A Firm has submitted both accelerated (40°C ± 2°C
&75±5%RH) stability studies & long term (25°C ±
2°C & 65±5%RH) stability studies reports of three
batches on query they provide the stability studies
on long term (30°C ± 2°C & 65±5%RH) by API
manufacturer
v. Details method of comparative dissolution. Comparative dissolution as required by standard is not
Why it‘s not performed on 3 mediums? applicable to modified or delayed release tablet
dosage form. Secondly firm has conducted and
provided data of comparative dissolution of Naproxen
in acidic medium and in pH 6.8 buffer.
Decision: Registration Board decided to approve registration of ―Esonap 20/500 Tablet
(Naproxen…….500 mg & Esomperazole (as Meagnesium) ...20 mg) by M/s Dyson Research Laboratories
(Pvt.)Ltd. 28th KM Ferozpur Road, Lahore. Manufacturer will place first three production batches of the
months.

No. Manufacturer / (Proprietary Name + Dosage Form Initial Diary & Availability / Local
Applicant + Strength), Composition, Date, Fee Availability
Pharmacological Group, (including
Finished Product Specification differential fee), GMP Inspection
Demanded Price / Report Date &
Pack size Remarks
1002. M/s Helix Pharma OMO / ASPER TABLETS Form-5D YOSPRALA Tablets
(Pvt.) Ltd. A-56, 81mg/40mg 81mg/40mg by
S.I.T.E, Dy. No. 1576 Arelez
Manghopir road, Each Film coated delayed released 4-05-2017 Pharmaceuticals US
Karachi. tablet contains: Inc.
Aspirin (Delayed-release)….81 mg Rs. 50,000/-
Omeprazole (Immediate (Challan # Not applicable
release)……. 40 mg 0587028)
GMP compliant
(PPI and analgesic) Pack Size: dated 24/09/2018
Firm has claimed Mfg. Specs. 10‘s , 20‘s & 30‘s
(Helix Pharma) (As per PRC)

Drug OMO / ASPER TABLETS 81mg/40mg
(Aspirin + Omeprazole)
Name of Manufacturer Helix Pharma (Pvt.) Ltd., Karachi.
Manufacturer of API Aspirin: M/s JQC (Huayin) Pharmaceutical Co.,Ltd. CHINA.
Omeprazole: M/s Metrochem API Pvt. Ltd, INDIA.
API Lot No. Aspirin: CA1709001

Omeprazole: OMP/1709477
Description of Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 3 ,6 (Months) Real Time : 0, 3 ,6 (Months)
Batch No. TF 001 TF 002 TF 003

Manufacturing Date 01 - 2018 01 – 2018 01 – 2018
No. of Batches 03

1. COA of API Yes

2. Approval of API by regulatory authority of country of Aspirin: Firm has submitted copy of
origin or GMP certificate of API manufacturer issued GMP Certificate (#SN20150132) of
by regulatory authority of country of origin. manufacturer ―JQC (Huayin)
Pharmaceutical Co., Ltd. CHINA.‖ issued
by SFDA, China which is valid till
29/04/2020.
Omeprazole: Firm has submitted copy
GMP Certificate of manufacturer
―Metrochem API Pvt Ltd, Plot No:
62/C/6, Pipeline road, Phase-I, IDA,
Jeedimetla INDIA‖ issued by Drugs
Control Administration, Government of
Telangara , India.
Yes
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested invoice
provided.
documents.
Yes
Yes
1978.
 Dissolution is according to USFDA.
Letter No. 1857 (R&I) dated 15-01-2018 and provided the following documents in conjunction with the
checklist approved by the Registration Board in its 276th Meeting.
1. Reference of last onsite panel  Registration Board approved RAMELTON Tablets 8mg
inspection for instant dosage form (Ramelteon) in its 273rd Meeting.
conducted during last two years. o Date of Inspection: 18-08-2017.
o The HPLC is 21CFR Compliant.
o Audit trail on the testing reports of ―Ramelton
(Ramelteon) Tablets 8mg were available.
2. Documents for the procurement of Aspirin: The firm has submitted photocopies of ADC
API with approval from DRAP (in (Karachi) attested Form 6 dated 30-11-2017, Commercial
case of import). Invoice attestation on dated 30/11/2017 for 0.8 Kg of Aspirin
Omeprazole: The firm has submitted photocopies of ADC
(Karachi) attested Form 6 dated 24-10-2017, Commercial
Invoice attestation on dated 24/10/2017 for 2.0 Kg of
Omeprazole.
3. Documents for the procurement of  The firm has submitted analytical reports/COA of
reference standard and impurity reference standard & impurity standards.
standards. Reference/Working standard: omeprazole and aspirin
provided
Impurity standard: omeprazole and aspirin provided

The firm has clarified that the reference standard and
impurity standards are procured along with the APIs‘
consignment and not separately.
4. Approval of API/ DML/GMP Aspirin: Firm has submitted copy of GMP Certificate of
certificate of API manufacturer issued manufacturer ―JQC (Huayin) Pharmaceutical Co.,Ltd.
by regulatory authority of country of CHINA.‖ issued by SFDA, China which is valid till
origin. 29/04/2020.
Omeprazole: Firm has submitted copy GMP Certificate of
manufacturer ―M/s Metrochem API Pvt. Ltd, INDIA‖ issued
by Drugs Control Administration, Government of Telangara,
India valid till 2018.
5. Mechanism for Vendor pre-  The firm has submitted copy of vender evaluation
qualification questionnaire for vender pre-qualification along with
filled questionnaire from both APIs manufacturers.
6. Certificate of analysis of the API,  ASPIRIN API:
reference standards and impurity Photocopy of COA of Batch No. CA1709001 issued by
standards ―M/s JQC (Huayin) Pharmaceutical Co.,Ltd. CHINA‖ is
submitted.
The firm has submitted copy of Working Standards
(Aspirin), USP Reference Standard and impurity
standards provided by the API Manufacturer - M/s JQC
(Huayin) Pharmaceutical Co.,Ltd. CHINA.
 OMEPRAZOLE API:
Photocopy of COA of Batch No. OMP/1709477 issued
by M/s Metrochem API Pvt. Ltd, INDIA is submitted.
(Omeprazole),USP Reference Standard and impurity
standards provided by the API Manufacturer - M/s
Metrochem API Pvt. Ltd, INDIA along with procuring
invoice of Reference standard & impurity standards.
7. Documents for the procurement of Firm has submitted copy of COAs for the excipients used in
excipients used in product the applied formulation.
development?
8. List of qualified staff involved in Firm has submitted copy of R&D staff list
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP with the title
development & stability testing of ‗Protocol For Development of New Product‘.
trial batches. Effective date 12-08-2017.
10. Complete batch manufacturing record The firm has submitted copy of Trial batch manufacturing
of three stability batches. record. Details are as under:
OMP TABLETS 81/40mg
Batch Bach size Mfg. Mfg.
No. Started Completed
TF001 500 Tabs 16-01-2018 16-01-2018
TF002 500 Tabs 17-01-2018 17-01-2018
TF003 500 Tabs 18-01-2018 18-01-2018
11. Record of remaining quantities of OMO Tablets 81/40mg ;
stability batches. Stability Pack Size : 3 x 10‘s
 TF001: Batch Size : 500 Tablets
Yield 492 Tablets (16 Packs) , 01 Pack used for testing
method validation. 01 Pack used for Initial testing, 01
Pack used for Comparative Dissolution Profile. 13
(3x10‘s) Packs placed on stability (Accelerated : 03 Packs
, Real Time : 10 Packs) out of which 09 packs are
remaining (Accelerated : 01 Pack , Real Time : 08 Packs).
Yield 493 Tablets (16 Packs) , 01 Pack used for Initial
testing. 15 (3x10‘s) Packs placed on stability (Accelerated
: 03 Packs , Real Time : 12 Packs) out of which 11 packs
are remaining (Accelerated : 01 Pack , Real Time : 10
Packs).
testing. 15 (3x10‘s) Packs placed on stability (Accelerated
: 03 Packs , Real Time : 12 Packs) out of which 11 packs
are remaining (Accelerated: 01 Pack , Real Time : 10
Packs).
QA/QC DATA
12. Record of Digital data logger for  Previously Reported in panel inspection:
temperature and humidity monitoring The firm has installed software for recording the
of stability chambers (real time and temperature/Humidity of the chamber (for real time stability
accelerated) software V5.7T Thermo, India & for Accelerated Stability
studies, software is Logit Chrt; Technoman; Pakistan) & the
data can been verified for 01 year.
Now the firm has submitted copy of record of digital data

logger (Logit Chart, Technoman) for temperature and
humidity monitoring of stability chambers.
13. Method used for analysis of API along  The firm has submitted photocopy of method used for
with COA. analysis of APIs (Aspirin) & Omeprazole) along with
COA.
complete record of testing of stability Specifications and Testing Method of OMO Tablets
batches (i.e. chromatograms, lab 81/40mg & OMO Tablets 325/40mg.
reports, raw data sheets etc.)  Complete record of testing of stability batches (i.e.
Real Time).
15. Reports of stability studies of API ASPIRIN: The firm has submitted copy of accelerated, 06
from manufacturer. Months (40°C ± 2°C & 75±5%RH) &long term, 48 Months
(30°C ± 2°C & 65±5%RH) stability study reports of 03
batches of ASPIRIN from M/s JQC (Huayin) Pharmaceutical
Co. Ltd. CHINA.
OMEPRAZOLE: The firm has submitted copy of

accelerated, 06 Months (25°C ± 2°C & 60±5%RH) &long
term, 60 Months (5°C ± 3°C) stability study reports of 03
batches of Omeprazole from M/s Metrochem API Pvt. Ltd,
INDIA.
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients used
in the applied formulation.
17. Drug-excipients compatibility studies.  The firm has not submitted Drug-excipients compatibility
studies and has referred to the Innovator Product
(YOSPRALA).

18. Record of comparative dissolution  Firm has submitted Comparative dissolution study of their
data. product (OMO Tablets all SKUs (81/40mg & 325/40mg)
with Innovator‘s Brand ―YOSPRALS‖ conducted on
following dates ;
 81/40 mg : 29/11/2018 to 04/12/2018
 325/40mg: 06/12/2018 to 12/12/2018
 The details are as follows:
Feature Reference Product Product of
HELIX Pharma
Brand name YOSPRALA Tablets OMO Tablets
81mg/40mg 81/40mg
Batch No. 3146921 TF001
Mfg. date Not mentioned 01-2018
Exp. 07-2019
Feature Reference Product Product of HELIX

Pharma
Brand name YOSPRALA Tablets OMO Tablets
325mg/ 40mg 325/40mg
Batch No. 3149884 TF001
Exp. 06-2019

following media:
ASPIRIN :
OMEPRAZOLE :
 Copy of Calculation Sheets and HPLC chromatograms
has been submitted for Comparative dissolution studies.
19. Compliance Record of HPLC The firm has submitted copy of Audit Trail for Initial, 3rd
software 21CFR & audit trail reports and 6th Month Testing Intervals of OMO TABLETS
on product testing. 81/40mg & OMO TABLETS 325/40mg.
Evaluation by PEC:
Clarification regarding GMP certificate, as on GMP Firm replied that the submitted GMP for
name of firm is JQC (Huayian) Pharmaceuticals but manufacturer of Aspirin JQC (Huayian)
on china FDA site firm certified under the provided Pharmaceuticals is the abbreviation of Huayin
certificate number is Huayin Jinjincheng Jinjincheng Pharmaceutical Co., Ltd. Is
Pharmaceutical Co., Ltd. Is mentioned mentioned on SFDA.
The GMP certificate of Metrochem API Pvt Ltd, India The GMP certificate of Metrochem API Pvt
is not valid after 2-2018. Provide the valid GMP Ltd, India valid up to 11-1-2019. Is provided
certificate
Mechanism for Vendor pre-qualification and list of Provided
R&D staff not attached only annexure heading is
attached
API stability of omeprazole at conditions of zone IV- The storage conditions of omeprazole is at cold
A as provided stability is at Accelerated: 25°C ± 2°C conditions that‘s whyAPI stability of
& 60±5%RH and Real Time: 5°C ± 3°C. omeprazole was provided at Accelerated: 25°C
± 2°C & 60±5%RH and Real Time: 5°C ± 3°C.

The innovators finished product release specifications As per USP monographs of uniformity of
tests for this dosage form including tests for content contents if the weight of the API is more than
uniformity Justify the exemption of these tests as it is 25 mg then the content uniformity test is
very important becauseomeprazole is being optional however as per your requirement they
incorporated via coating solution. provides the content uniformity test of
omeprazole on the base of weight variation
Since API of omeprazole is being incorporated via Since API of omeprazole is being incorporated
coating solution so how it is possible to ensure that via coating solution to ensure proper amount of
proper amount of active has been incorporated in active has been incorporated in dosage using
dosage form while using 100% quantity in master 50% overage that has already been submitted
formulation along with stability.
Decision: Registration board decided to defer the case for submission of stability studies of three
batches of API both accelerated & real time according to zone IV-A conditions.
No. Manufacturer / (Proprietary Name + Dosage Form + Initial Diary & Availability /
Applicant Strength), Composition, Date, Fee (including Local
Pharmacological Group, differential fee), Availability
Finished Product Specification Demanded Price /
Pack size GMP Inspection
Report Date &
Remarks
1003. M/s Helix Pharma OMO / ASPER TABLETS 325 Form-5D YOSPRALA
(Pvt.) Ltd. A-56, mg/40mg Tablets
SITE, Manghopir Each tablet contains: Dy. No. 1575 325mg/40mg by
road, Karachi. Aspirin (Delayed-release)….325 mg 04-5-2017 Arelez
Omeprazole (Immediate release) Pharmaceuticals
.................40 mg Rs. 50,000/- US Inc.
(PPI and analgesic) (Challan # 0587027) Not applicable
Firm has claimed Mfg. Specs. (Helix Pack Size:
Pharma) 10‘s , 20‘s & 30‘s GMP compliant
(As per PRC) dated 24/9/2018

Drug OMO / ASPER TABLETS 325 mg/40mg
(Aspirin + Omeprazole)
Manufacturer of API Aspirin: M/s JQC (Huayin) Pharmaceutical Co.,Ltd. CHINA.
Omeprazole: M/s Metrochem API Pvt. Ltd, INDIA.
API Lot No. Aspirin : CA1709001

Omeprazole : OMP/1709477
Description of Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 3 ,6 (Months)
Real Time : 0, 3 ,6 (Months)

Manufacturing Date 01 - 2018 01 – 2018 01 – 2018
No. of Batches TF 001

1. COA of API Yes
2. Approval of API by regulatory authority of country of origin Aspirin: Firm has submitted copy of
or GMP certificate of API manufacturer issued by GMP Certificate of manufacturer ―JQC
regulatory authority of country of origin. (Huayin) Pharmaceutical Co.,Ltd.
CHINA.‖ issued by SFDA,China
which is valid till 29/04/2020.
Omeprazole: Firm has submitted copy
GMP Certificate of manufacturer ―M/s
Metrochem API Pvt. Ltd, INDIA‖
issued by Drugs Control
Administration, Government of
Telangara, India.
Yes
details of tests.
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested
invoice provided.
stamp) for ensuring authenticity of data / documents. Yes

Yes
2. Documents for the procurement of API Aspirin: The firm has submitted photocopies of ADC
with approval from DRAP (in case of (Karachi) attested Form 6 dated 30-11-2017, Commercial
import). Invoice attestation on dated 30/11/2017 for 0.8 Kg of Aspirin
Omeprazole: The firm has submitted photocopies of ADC
(Karachi) attested Form 6 dated 24-10-2017, Commercial
Invoice attestation on dated 24/10/2017 for 2.0 Kg of
Omeprazole .
3. Documents for the procurement of  The firm has submitted analytical reports/COA of reference
reference standard and impurity standard & impurity standards.
standards.  The firm has clarified that the reference standard and
impurity standards are procured along with the APIs‘
consignment and not separately.
4. Approval of API/ DML/GMP Aspirin: Firm has submitted copy of GMP Certificate of
certificate of API manufacturer issued manufacturer ―JQC (Huayin) Pharmaceutical Co.,Ltd.
by regulatory authority of country of CHINA.‖ issued by SFDA,China which is valid till 29/04/2020.
origin.
Omeprazole: Firm has submitted copy GMP Certificate of
manufacturer ―M/s Metrochem API Pvt. Ltd, INDIA‖ issued by
Drugs Control Administration, Government of Telangara ,
India.
qualification questionnaire for vender pre-qualification along with filled
questionnaire from both APIs manufacturers.
6. Certificate of analysis of the API,  ASPIRIN API:
reference standards and impurity Photocopy of COA of Batch No. CA1709001 issued by
standards ―M/s JQC (Huayin) Pharmaceutical Co.,Ltd. CHINA‖ is
submitted.
(Aspirin), USP Reference Standard and impurity standards
provided by the API Manufacturer - M/s JQC (Huayin)
Pharmaceutical Co.,Ltd. CHINA.
 OMEPRAZOLE API:
Photocopy of COA of Batch No. OMP/1709477 issued by
M/s Metrochem API Pvt. Ltd, INDIA is submitted.
(Omeprazole),USP Reference Standard and impurity
standards provided by the API Manufacturer - M/s
Metrochem API Pvt. Ltd, INDIA along with procuring
invoice of Reference standard & impurity standards.
7. Documents for the procurement of Firm has submitted copy of COAs for the excipients used in the
excipients used in product applied formulation.
development?
experience.
Production Data
development & stability testing of ‗Protocol For Development Of New Product‘.
10. Complete batch manufacturing The firm has submitted copy of Trial batch manufacturing
record of three stability batches. record. Details are as under:
OMP TABLETS 325/40mg

Batch Bach size Mfg. Mfg.
No. Started Completed
TF001 500 Tabs 22-01-2018 22-01-2018
TF002 500 Tabs 23-01-2018 23-01-2018
TF003 500 Tabs 24-01-2018 24-01-2018

11. Record of remaining quantities of OMO Tablets 325/40mg ;
stability batches. Stability Pack Size : 3 x 10‘s
Yield 492 Tablets (16 Packs) , 01 Pack used for testing
method validation. 01 Pack used for Initial testing, 01 Pack
used for Comparative Dissolution Profile. 13 (3x10‘s)
Packs placed on stability (Accelerated : 03 Packs , Real
Time : 10 Packs) out of which 09 packs are remaining
(Accelerated : 01 Pack , Real Time : 08 Packs).
testing. 15 (3x10‘s) Packs placed on stability (Accelerated :
03 Packs , Real Time : 12 Packs) out of which 11 packs are
testing. 15 (3x10‘s) Packs placed on stability (Accelerated :
03 Packs , Real Time : 12 Packs) out of which 11 packs are
QA/QC DATA
temperature and humidity monitoring The firm has installed software for recording the
of stability chambers (real time and temperature/Humidity of the chamber (for real time stability
accelerated) software V5.7T Thermo, India & for Accelerated Stability
studies, software is Logit Chrt; Technoman; Pakistan) & the
data can been verified for 01 year.
Now the firm has submitted copy of record of digital data
logger (Logit Chart, Technoman) for temperature and
humidity monitoring of stability chambers.
13. Method used for analysis of API along  The firm has submitted photocopy of method used for
with COA. analysis of APIs (Aspirin) & Omeprazole) along with
COA.
complete record of testing of stability Specifications and Testing Method of OMO Tablets
batches (i.e. chromatograms, lab 81/40mg & OMO Tablets 325/40mg.
reports, raw data sheets etc.)  Complete record of testing of stability batches (i.e.
Real Time).
15. Reports of stability studies of API from ASPIRIN : The firm has submitted copy of accelerated, 06
manufacturer. Months (40°C ± 2°C & 75±5%RH) &long term, 48
Months (30°C ± 2°C & 65±5%RH) stability study reports of
03 batches of ASPIRIN from M/s JQC (Huayin)
OMEPRAZOLE: The firm has submitted copy of

accelerated, 06 Months (25°C ± 2°C & 60±5%RH) &long
term, 60 Months (5°C ± 3°C) stability study reports of 03
batches of Omeprazole from M/s Metrochem API Pvt. Ltd,
INDIA.
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients
used in the applied formulation.
17. Drug-excipients compatibility studies.  The firm has not submitted Drug-excipients
compatibility studies and has referred to the Innovator
Product (YOSPRALA).

18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study of
their product (OMO Tablets all SKUs (81/40mg &
325/40mg) with Innovator‘s Brand ―YOSPRALS‖
conducted on following dates ;
 81/40 mg : 29/11/2018 to 04/12/2018
 325/40mg : 06/12/2018 to 12/12/2018
Product HELIX Pharma
Brand name YOSPRALA OMO Tablets
Tablets 81/40mg
81mg/40mg
Batch No. 3146921 TF001
Exp. 07-2019

Product HELIX Pharma
Brand name YOSPRALA OMO Tablets
Tablets 325/40mg
325mg/40mg
Batch No. 3149884 TF001
Exp. 06-2019
following media:
ASPIRIN :
OMEPRAZOLE :
 Copy of Calculation Sheets and HPLC chromatograms
has been submitted for Comparative dissolution studies.
19. Compliance Record of HPLC software The firm has submitted copy of Audit Trail for Initial, 3rd
21CFR & audit trail reports on product and 6th Month Testing Intervals of OMO TABLETS
testing. 81/40mg & OMO TABLETS 325/40mg.
Evaluation by PEC:
Clarification regarding GMP certificate, as on GMP name Firm replied that the submitted GMP for
of firm is JQC (Huayian) Pharmaceuticals but on china manufacturer of Aspirin JQC (Huayian)
FDA site firm certified under the provided certificate Pharmaceuticals is the abbreviation of
number is Huayin Jinjincheng Pharmaceutical Co., Ltd. Is Huayin Jinjincheng Pharmaceutical Co., Ltd.
mentioned Is mentioned on SFDA.
The GMP certificate of Metrochem API Pvt Ltd, India is The GMP certificate of Metrochem API Pvt
not valid after 2-2018. Provide the valid GMP certificate Ltd, India valid up to 11-1-2019. Is provided
Mechanism for Vendor pre-qualification and list of R&D Provided
staff not attached only annexure heading is attached
API stability of omeprazole at conditions of zone IV-A as The storage conditions of omeprazole is at
provided stability is at Accelerated: 25°C ± 2°C & cold conditions that‘s whyAPI stability of
60±5%RH and Real Time: 5°C ± 3°C. omeprazole was provided at Accelerated:
25°C ± 2°C & 60±5%RH and Real Time:
5°C ± 3°C.
The innovators finished product release specifications testsAs per USP monographs of uniformity of
for this dosage form including tests for content uniformity contents if the weight of the API is more
Justify the exemption of these tests as it is very importantthan 25 mg then the content uniformity test is
becauseomeprazole is being incorporated via coating optional however as per your requirement
solution. they provides the content uniformity test of
omeprazole on the base of weight variation
Since API of omeprazole is being incorporated via coating Since API of omeprazole is being
solution so how it is possible to ensure that proper amount incorporated via coating solution to ensure
of active has been incorporated in dosage form while proper amount of active has been
using 100% quantity in master formulation incorporated in dosage using 50% overage
that has already been submitted along with
stability.
Decision: Registration Board decided to approve registration of ―OMO / ASPER TABLETS 325
mg/40mg (Aspirin + Omeprazole) by M/ s Helix Pharma (Pvt.) Ltd., Karachi. Manufacturer will place
first three production batches of the product on long term stability studies throughout proposed shelf
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local
Applicant Dosage Form + Strength), Fee (including Availability
1004. M/s Helix Pharma NAP-X Tablets 500/20mgForm-5D VIMOVO Tablets
(Pvt.) Ltd. A-56, Each tablet contains: Dy. No. Duplicate 500/20mg by
S.I.T.E, Manghopir Naproxen (delayed released)
dossier AstraZeneca Canada
road, Karachi. ……..500mg 08-2010 Inc.
Esomeprazole as magnesium
Rs. 150,00/-(27-Aug-
(immediate 2010), 90,000/-(31-5-
release)……20mg 2013 Challan # Not applicable
0001138) Duplicate
Firm has claimed Mfg. Pack Size: GMP compliant dated
Specs. (Helix Pharma) 10‘s , 20‘s , 30‘s 24/09/2018
(As per PRC)

Drug NAP-X Tablets 500/20mg (Naproxen + Esomeprazole)
Manufacturer of API Naproxen Sodium: M/s Zhejiang Charioteer Pharmaceutical Co., Ltd.
CHINA.
Esomeprazole -Mg: M/s Smilax Laboratories Ltd, Plot # 70 & 71, JN
Pharma city, Parawada, Visakhapatnam-531021, Andhera Pradesh INDIA.
API Lot No. Naproxen Sodium: 176315A61
Esomeprazole -Mg: EOV1705007
Description of Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 3 ,6 (Months) Real Time : 0, 3 ,6 (Months)

Manufacturing Date 02 – 2018 02 - 2018 02 – 2018
No. of Batches 03
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country Naorpxen Sodium: Firm has submitted copy of
of origin or GMP certificate of API manufacturer GMP Certificate of manufacturer ―Zhejiang
issued by regulatory authority of country of origin. Charioteer Pharmaceutical Co., Ltd. CHINA.‖ (#
ZJ20150090) issued by SFDA, China which is
valid till 07/06/2020.
Esomeprazole-Mg: Firm has submitted copy
GMP Certificate of manufacturer ―M/s Smilax
Laboratories Ltd, INDIA‖ (#1550/DD/
DCA/VSP/2017) issued by Drugs Control
Administration, Visakhapatnam Region, India.
Yes
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested invoice
provided.
documents.
Yes
Yes
1978.
 Dissolution is according to USFDA.
2. Documents for the procurement of Naproxen Sodium: The firm has submitted photocopies of ADC
API with approval from DRAP (in (Karachi) attested Form 6 dated 07-02-2018, Commercial Invoice
case of import). attestation on dated 07/02/2018 for 2.5 Kg of Naproxen Sodium.
Esomeprazole-Mg: The firm has submitted photocopies of FedEx
paper along with Proforma Invoice for Esomeprazole-Mg.

3. Documents for the procurement of  The firm has submitted analytical reports/COA of reference
reference standard and impurity standard & impurity standards.
standards.  The firm has clarified that the reference standard and impurity
standards are procured along with the APIs‘ consignment and
not separately.
4. Approval of API/ DML/GMP Naorpxen Sodium: Firm has submitted copy of GMP Certificate
certificate of API manufacturer of manufacturer ―Zhejiang Charioteer Pharmaceutical Co., Ltd.
issued by regulatory authority of CHINA.‖ issued by SFDA, China which is valid till 07/06/2020.
country of origin. Esomeprazole-Mg: Firm has submitted copy GMP Certificate of
manufacturer ―M/s Smilax Laboratories Ltd, INDIA‖ issued by
Drugs Control Administration, Visakhapatnam Region, India.
Valid up to 1-2019
questionnaire from API‘s manufacturer.
6. Certificate of analysis of the API,  Naproxen Sodium API:
reference standards and impurity Photocopy of COA of Batch No. 176315A61 issued by
standards ―Zhejiang Charioteer Pharmaceutical Co.,Ltd. CHINA‖ is
submitted.
The firm has submitted copy of Working Standards (Naproxen
Sodium), USP Reference Standard.
Esomeprazole - Mg API:
Photocopy of COA of Batch No. EOV1705007 issued by M/s
Smilax Laboratories Ltd, INDIA is submitted.
(Esomeprazole-Mg),USP Reference Standard.
7. Documents for the procurement of Firm has submitted copy of COAs/Procurement documents for the
excipients used in product excipients used in the applied formulation.
development?
experience.
Production Data
development & stability testing of ‗Protocol For Development Of New Product‘.
10. Complete batch manufacturing The firm has submitted copy of Trial batch manufacturing record.
record of three stability batches. Details are as under:
NAP-X TABLETS 500/20mg
TF001 1000 Tabs 02-02-2018 03-02-2018
TF002 1000 Tabs 06-02-2018 07-02-2018
TF003 1000 Tabs 08-02-2018 09-02-2018
11. Record of remaining quantities of NAP-X Tablets 500/20mg ;
stability batches. Stability Pack Size : 30‘s
Yield 985 Tablets (32 Packs) , 02 Pack used for testing method
validation. 01 Pack used for Initial testing, 02 Pack used for
Comparative Dissolution Profile. 15 (3x10‘s) Packs placed on
stability (Accelerated : 06 Packs , Real Time : 9 Packs) out of
which 11 packs are remaining (Accelerated : 04 Pack , Real
Time : 07 Packs).
Yield 987 Tablets (32 Packs) , 01 Pack used for Initial testing.
15 (3x10‘s) Packs placed on stability (Accelerated : 06 Packs ,
Real Time : 09 Packs) out of which 11 packs are remaining
Yield 989 Tablets (32 Packs) , 01 Pack used for Initial testing.
15 (3x10‘s) Packs placed on stability (Accelerated : 06 Packs ,
Real Time : 09 Packs) out of which 11 packs are remaining
QA/QC DATA
temperature and humidity The firm has installed software for recording the
monitoring of stability chambers temperature/Humidity of the chamber (for real time stability
(real time and accelerated) software V5.7T Thermo, India & for Accelerated Stability studies,
software is Logit Chrt; Technoman; Pakistan) & the data can been
verified for 01 year.
Now, the firm has submitted copy of record of digital data logger
(Logit Chart, Technoman) for temperature and humidity monitoring
of stability chambers.
13. Method used for analysis of API The firm has submitted photocopy of method used for analysis of
along with COA. APIs (Naproxen Sodium) & Esomeprazole-Mg) along with COA.
complete record of testing of Specifications and Testing Method of NAP-X Tablets
stability batches (i.e. 500/20mg.
chromatograms, lab reports, raw  Complete record of testing of stability batches (i.e.
data sheets etc.) chromatograms, lab reports, raw data sheets etc.) are submitted
with 06 months stability data (Accelerated & Real Time).
15. Reports of stability studies of API NAPROXEN SODIUM : The firm has submitted copy of
from manufacturer. accelerated, 06 Months (40°C ± 2°C & 75±5%RH) &long term,
36 Months (30°C ± 2°C & 65±5%RH) stability study reports of 03
batches of Naproxen Sodium from M/s Zhejiang Charioteer
ESOMEPRAZOLE : The firm has submitted copy of accelerated,
06 Months (40°C ± 2°C & 75±5%RH) &long term, 36 Months
(30°C ± 2°C & 65±5%RH) stability study reports of 03 batches of
Esomeprazole from M/s Smilax Laboratories Ltd, INDIA.
16. Analysis reports for excipients The firm has submitted copy of COAs for the excipients used in the
used. applied formulation.
17. Drug-excipients compatibility  The firm has not submitted Drug-excipients compatibility
studies. studies and has referred to the Innovator Product (VIMOVO).
18. Record of comparative dissolution  Firm has submitted Comparative dissolution study of their
data. product (NAP-X Tablets 500/20mg with Innovator‘s Brand
―VIMOVO‖ conducted on following dates ;
 500/20 mg : 09/01/2019 to 15/01/2019
Feature Reference Product Product of Helix Pharma
Brand name VIMOVO Tablets NAP-X Tablets 500/
500mg/20mg 20mg
Batch No. DAGN TF 001
Exp.
following media:

NAPROXEN :
iii. pH 6.8 Phosphate buffer solution.
ESOMEPRAZOLE :
 Copy of Calculation Sheets and HPLC chromatograms has
been submitted for Comparative dissolution studies.
19. Compliance Record of HPLC The firm has submitted copy of Audit Trail for Initial, 3 rd and 6th
software 21CFR & audit trail Month Testing Intervals of NAP-X TABLETS 500/20mg.
Evaluation by PEC:
Above observation were communicated to firm vide letter no. F.1-1/2019/PEC-DRAP (AD PEC-VII), to
which firm has responded as under:
vi. The innovator product is as naproxen alone not as Please be informed that ―we have applied
naproxen sodium as applied by the firm. formulation naproxen + esomeprazole a
Justification is needed magnesium in applied dossier. In submitted
stability data we are using salt of naproxen
i.e. naproxen sodium but we have derived
contents naproxen by applying factor in the
calculation sheets‖.
vii. The GMP certificate of Smilax lab Ltd, India is not GMP certificate of Smilax lab Ltd, India
valid after 1-2019. Provide the valid GMP issued on 18-1-2019 valid for 3 years is
certificate provided.
viii. Documents for the procurement of API Firm reply that they received the documents
esomeprazole with approval from DRAP is needed through FedEx.
as only the photocopies of FedEx invoice is FedEx documents are provided
submitted without any AD attestation
ix. In USFDA dissolution method, Type II (Paddle) The firm claim that ―we have followed
with sinkers are used but in applied finished USFDA dissolution method by using type II
product specification sinker I not mentioned. (Peddle) and sinkers but missed to mentioned
Clarification is needed sinkers in FP testing method and
comparative dissolution profile. We are
enclosing revised FP testing protocol along
with procuring documents od sinkers‖
x. API stability of esomeprazole at Accelerated Provided
conditions is not submitted
Decision:Registration Board decided to reject the registration application of applied formulation as it
contains Naproxen Sodium but reference product product contains Naproxen only so the applied
formulation is not generic to innovator.
1005. Duplicate Of Case At Serial No. 990

No. of Manufacturer (Proprietary Name + Dosage Initial Diary & Date, Availability / Local
/ Applicant Form + Strength), Fee (including Availability
Remarks
1006. M/s Wilsons‘s Sofvasc Trio Tablet Form-5-D Tribenzor, USFDA
Pharmaceuticals Each film coated Tablet Fast Track 10‘s, 20‘s approved
Plot No. 387- contains: & 30‘s Rs.559/- per Triday of werrick
388, Sector I-9 Olmesartan medoxomil tablet pharma
Industrial area, ….40mg 11-12-2010/ 335 GMP compliant dated
Islamabad. Amlodipine as besylate 17-05-2013/ 3125 24-01-2018
…….10mg Rs.60,000/- ―Overall the firm was
Hydrochlorothiazide ……...25 (duplicate) found to be operating
mg at a very good level of
Anti-Hypertensive agent CGMP Compliance at
Diuretic the time of inspection.‖

Drug Sofvasc Trio Tablet
Name of Manufacturer M/s Wilsons‘s Pharmaceuticals Plot No. 387-388, Sector I-9 Industrial area,
Islamabad.
Manufacturer of API Amlodipine besilate: M/s Hetero Drugs Limited (Unit-IV), India.
Olmesartan medoxomil: M/s Glenmark Pharmaceuticals Ltd. India.
Hydrochlorothiazide: M/s Suzhou Lixin Pharmaceutical Co. Ltd, China
API Lot No. Olmesartan medoxomil: 83170554
Amlodipine besilate: AM0321216 and AM0331216
Hydrochlorothiazide: C01-20170102
Description of Pack
Condition Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 1,2,3, 4 ,6 (Months)
Batch No. Trail 001 Trail 001 Trail 001
No. of Batches 03
Date of Submission 14-1-2019 ( D # 1670)

1. COA of API Yes
2. Approval of API by regulatory authority of country Olmesartan medoxomil:
of origin or GMP certificate of API manufacturer M/s Glenmark Pharmaceuticals Ltd. India:

issued by regulatory authority of country of origin. Photocopy of GMP Certificate No. 1708289
issued by Food & Drugs Control
Administration (Gujarat) India, valid up to 18-
08-2019 is submitted.
Amlodipine besilate:
M/s Hetero Drugs Limited (Unit-IV), India:
Photocopy of GMP Certificate No.
6208/E(G)/TS/2017 issued by Drugs Control
Administration (Telangana) India, valid up to
21-04-2018 is submitted.
Hydrochlorothiazide:
M/s Suzhou Lixin Pharmaceutical Co. Ltd,
China: Photocopy of GMP Certificate No.
JS20140325 issued by Jiangsu Food and Drug
Administration China, valid up to 25-08-2019
is submitted.
Yes
5. Documents confirming import of API etc. Copy of ADC attested Form 5, form 3 and
commercial invoice provided for all 3 actives.
Amlodipine as besylate Quantity… 300 kg
Olmesartan medoxomil Quantity… 100 kg
Hydrochlorothiazide Quantity…300 kg
documents.
Yes
Yes
1978.
vii. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-
VII), to which firm has responded as under:
1. Reference of last onsite panel Registration Board decided to approve Registration of ―Saferon
inspection for instant dosage form (Sofosbuvir 400mg) tablets by M/s Wilson Pharmaceuticals, I-9
conducted during last two years. Industrial Area, Islamabad in its 278th Meeting.
Date of Inspection: 10-12-2015, 19-04-2017 & 20-01-2018
compliant and audit trail on the testing reports was available and
confirmed.
2. Documents for the procurement Amlodipine as besylate:
of API with approval from DRAP The firm has submitted photocopies of ADC (Islamabad) attested
(in case of import). Form 5, Commercial Invoice issued by M/s Hetero corporate,
INDIA attestation on dated 23/Dec/2016 for 300 kg of
Amlodipine. The firm has imported Raw Material ,Qty ; 12x25 kg
; Batch # AM0321216 and AM0331216
Olmesartan medoxomil: The firm has submitted photocopies of
ADC (Islamabad) attested Form 5 and commercial invoice dated

11/10/2017. Commercial Invoice is issued by M/s Glenmark
Pharma Ltd, INDIA Moreover detail of Qty; 10 kg; Batch
83170554 is mentioned on invoice.
The firm has submitted photocopies of ADC (Islamabad) attested
Form 5 and AD attested commercial invoice issued by M/s Suzhou
Lixin Pharmaceutical Co. Ltd, China dated 29/3/17. Commercial
Invoice is issued by M/s Suzhou Lixin Pharma Co. Ltd, China
Moreover detail of Qty; 300 kg ; Batch # C01-20170102 is
mentioned on invoice
3. Documents for the procurement Hydrochlorthiazide
of reference standard and Working Standard
impurity standards. 1g from 3J Diagnostic, TRC Canada
Impurities
Impurity A (Suzhou Lixin Pharmaceutical Co. Ltd)
Impurity B (Suzhou Lixin Pharmaceutical Co. Ltd)
Chlorthiazide
Benzothiadiazine Related Compound A
Amlodipine Besylate Working Standard
Working Standard
25g from 3J Diagnostic, , TRC Canada
Olmesartan Medoxomil Working Standard
Working Standard
1g from 3J Diagnostic, , TRC Canada
Olmesartan Impurity A (Synpure Labs)
Olmesartan Olefenic Impurity (Synpure Labs)
Olmesartan Related Compound A(Synpure Labs)
Omlesartan Alkyl Impurity(Synpure Labs)
4. Approval of API/ DML/GMP Amlodipine as besylate:
certificate of API manufacturer M/s Hetero Drugs Limited (Unit-IV), India: Photocopy of GMP
issued by regulatory authority of Certificate No. 6208/E(G)/TS/2017 issued by Drugs Control
country of origin. Administration (Telangana) India, valid up to 18-5-2020 is
submitted.
Olmesartan medoxomil:
M/s Glenmark Pharmaceuticals Ltd. India: Photocopy of GMP
Certificate No. 1708289 issued by Food & Drugs Control
Administration (Gujarat) India, valid up to 18-08-2019 is
submitted.
M/s Suzhou Lixin Pharmaceutical Co. Ltd, China: Photocopy of
GMP Certificate No. JS20140325 issued by Jiangsu Food and
Drug Administration China, valid up to 25-08-2019 is submitted.
questionnaire from APIs manufacturer.
6. Certificate of analysis of the API, Amlodipine as besylate API:
reference standards and impurity Photocopy of COA of Batch No. AM0331216 issued by ―
standards M/s Hetero Drugs Limited (Unit-IV), India‖ is submitted.
The firm has submitted copy of Reference Standard and
impurity standards are provided
Olmesartan medoxomil API:
Photocopy of COA of Batch No. 83170554 issued by M/s
Glenmark Pharmaceuticals Ltd. India is submitted.
The firm has submitted copy of Reference Standard and impurity

standards are provided
Hydrochlorothiazide API:
Photocopy of COA of Batch No. C01-20170102 issued by
M/s Suzhou Lixin Pharmaceutical Co. Ltd, China is submitted.
7. Documents for the procurement Firm has submitted copy of commercial invoices for the excipients
of excipients used in product used in the applied formulation.
development?
8. List of qualified staff involved in Firm has submitted copy of R&D staff list. 17 personals are
product development with present in there R &D
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of SOP with the title
development & stability testing of ‗Protocols/standard operating procedure for the development of
trial batches. Sofvasc trio tablet 40/10/25 mg tablet‖
Effective date not mentioned
Trail#1 1500 Tabs 2-2018
Trail#2 1500 Tabs 2-2018
Trail#3 1500 Tabs 2-2018
11. Record of remaining quantities of Trapeze plus XR ;
stability batches. Stability Pack Size :
 Trail #1: Batch Size : 1500 Tablets
Yield 1320 Tablets ,
124 tablets used for testing
other are remaining
other are remaining
other are remaining
QA/QC DATA
monitoring of stability chambers temperature/Humidity of the chamber (for real time stability & for
(real time and accelerated) Accelerated Stability studies)
Now the firm has submitted copy of record of digital data logger
for temperature and humidity monitoring of stability chambers.
13. Method used for analysis of API  The firm has submitted photocopy of method used for analysis
along with COA. of APIs along with COA.
14. Method used for analysis of FPP  The firm has submitted photocopy of Finished Product
& complete record of testing of Specifications and Testing Method of applied product and its
stability batches (i.e. validation data.
data sheets etc.) chromatograms, lab reports, raw data sheets etc.) are
submitted with 06 months stability data (Accelerated & Real
Time).
15. Reports of stability studies of API Amlodipine as besylate:
from manufacturer. The firm has submitted copy of accelerated, 06 Months (40°C ±
2°C & 75±5 % RH) &long term, 36 Months (30°C±2°C &
65±5% RH) stability study reports of 03 batches
Olmesartan medoxomil
The firm has submitted copy of accelerated, 06 Months (40°C ±
65±5%RH) stability study reports of 03 batches
16. Analysis reports for excipients The firm has submitted copy of COAs for the excipients used in
used. the applied formulation.
studies. studies and provides excipient analysis report
18. Record of comparative  Firm has submitted Comparative dissolution study of their
dissolution data. product Sofvasc trio with Innovator‘s Brand ―Tribenzor‖
conducted on following dates:
following media:
Amlodipine as besylate:
19. Compliance Record of HPLC The firm has submitted copy of Audit Trail for Initial, 3rd and 6th
software 21CFR & audit trail Month Testing Intervals
Evaluation by PEC:
Dissolution parameters stated in finished product testing method, submitted along with stability studies data
are recommended by USFDA.
Amlodipine Besylate/Hydrochlorothiazide/Olmesartan Medoxomil:
Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45

Submit raw data sheets of all time points. Provide Provided
concentrations of standard and sample solution
used in assay and dissolution, as it is not clear
from the provided method.

Clarification regarding peak resolution as some Peak resolution was found by the firm and new
peaks are merged in method validation (e.g. in chromatograms are submitted. A resolution of 1.5 or
sample ID ―sys suitably 6‖ and in ―linearity- greater between the peaks will ensure that the
150%‖ etc.) sample components are well (baseline) separated to
degree at which the area or height of each peak may
be accurately measured. No resolution was found to
be less than 2.
Valid GMP certificate is required as Photocopy of Valid GMP certificate No. 6208/E(G)/TS/2017
GMP Certificate No. 6208/E(G)/TS/2017 issued issued by Drugs Control Administration
by Drugs Control Administration (Telangana) (Telangana) India was valid up to 21-04-2018 is
India was valid up to 21-04-2018 provided
List of qualified staff involved in product Provided
development with relevant experience does not
mentioned their qualifications.
COA of Impurity standard of amlodipine are not Provided
provided same is required.
Impurities analysis not performed for finished Provided
product. Clarify and justify
Decision: Registration Board decided to approve registration of ―Sofvasc Trio Tablet 40/10/25 mg by
Wilsons‘s Pharmaceuticals, Islamabad. Manufacturer will place first three production batches of the
months.
Remarks
1007. M/s Wilsons‘s Sofvasc Trio Tablet 40/5/25 mg Form-5-D Tribenzor, USFDA
Pharmaceuticals Each film coated Tablet Fast Track approved
Plot No. 387-388, contains: 10‗s,20‗s&30‗ Triday of werrick
Sector I-9 Olmesartan medoxomil ….40 s Rs.522/- per pharma
Industrial area, mg tablet GMP compliant dated
Islamabad. Amlodipine as besylate …….5 11-12-2010/337 24-01-2018
mg Hydrochlorothiazide 17-05-2013/ 3125 ―Overall the firm was
……...25 mg Rs.60,000/- found to be operating
Anti-Hypertensive agent (duplicate) at a very good level of
Diuretic CGMP Compliance at
the time of inspection‖

Drug Sofvasc Trio Tablet 40/5/25 mg
Islamabad.
Description of Pack

No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Olmesartan medoxomil:
is submitted.
Yes
documents.
Yes

1978.
viii. Above observation were communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PEC-
VII), to which firm has responded as under:
inspection for instant dosage (Sofosbuvir 400mg) tablets by M/s Wilson Pharmaceuticals, I-9
form conducted during last two Industrial Area, Islamabad in its 278th Meeting.
years. Date of Inspection: 10-12-2015, 19-04-2017 & 20-01-2018
confirmed.
of API with approval from The firm has submitted photocopies of ADC (Islamabad) attested
DRAP (in case of import). Form 5, Commercial Invoice issued by M/s Hetero corporate,
; Batch # AM0321216 and AM0331216
3. Documents for the procurement The firm has submitted the commercial invoice of the reference
of reference standard and standard and impurity standard purchased from different source
impurity standards. other then API manufacturer.
submitted.
submitted.
GMP Certificate No. SU20160171 issued by Jiangsu Food and
Drug Administration China, valid up to 31-december-2020 is
submitted.
6. Certificate of analysis of the Amlodipine as besylate API:

API, reference standards and Photocopy of COA of Batch No. AM0331216 issued by ―
impurity standards M/s Hetero Drugs Limited (Unit-IV), India‖ is submitted.
development?
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of SOP with the title
the development & stability ‗Protocols/standard operating procedure for the development of
testing of trial batches. Sofvasc trio tablet 40/10/25 mg tablet‖
Effective date not mentioned
Trail#1 1500 Tabs 2-2018
Trail#2 1500 Tabs 2-2018
Trail#3 1500 Tabs 2-2018
11. Record of remaining quantities Trapeze plus XR ;
of stability batches. Stability Pack Size :
600 tablets used for stability
568 are remaining
568 are remaining
568 are remaining
QA/QC DATA
monitoring of stability chambers temperature/Humidity of the chamber (for real time stability & for
Time).
15. Reports of stability studies of Amlodipine as besylate:
API from manufacturer. The firm has submitted copy of accelerated, 06 Months (40°C ±
2°C & 75±5 % RH) &long term, 48 Months(30°C±2°C &
studies. studies and provides excipient analysis report
conducted on following dates ;
following media:

Evaluation by PEC:
Qualification of qualified person not mentioned ------
COA of Impurity standard are not provided and some

COA‘s of standards were purchased from different
manufacture (TRC, Synpure labs, then the API
manufacturer. Justify/clarify.
COA of Impurity standard of amlodipine are not provided -------
same is required.
Decision: Registration Board after thorough deliberation deferred the case for scientific justification
of use of working standard from manufacturer other than API manufacturer.
Finished Product Specification Pack size Report Date
&Remarks
1008. M/s Wilsons‘s Sofvasc Trio Tablet Each Form-5-D Fast Track Tribenzor, USFDA
Pharmaceuticals Tablet contains: Olmesartan 10‘s, 20‘s & 30‘s approved
Plot No. 387-388, medoxomil ….20mg Rs.410/- per tablet Triday of werrick
Sector I-9 Amlodipine as besylate 11-12-2010/339 pharma
Industrial area, …..5mg Hydrochlorothiazide 17-05-2013/ GMP compliant dated
Islamabad. ……..12.5mg 3125 24-01-2018
Anti-Hypertensive agent Rs.60,000/- ―Overall the firm was
Diuretic (duplicate) found to be operating
at a very good level of
CGMP Compliance at
the time of inspection‖

Drug Sofvasc Trio Tablet 20/5/12.5 mg
Islamabad.
Description of Pack

No. of Batches 03

No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country Olmesartan medoxomil:
is submitted.
Yes
documents.
Yes
Yes
1978.

inspection for instant dosage (Sofosbuvir 400mg) tablets by M/s Wilson Pharmaceuticals, I-9
form conducted during last two Industrial Area, Islamabad in its 278th Meeting.
years. Date of Inspection: 10-12-2015, 19-04-2017 & 20-01-2018
confirmed.
of API with approval from The firm has submitted photocopies of ADC (Islamabad) attested
DRAP (in case of import). Form 5, Commercial Invoice issued by M/s Hetero corporate,
; Batch # AM0321216 and AM0331216
3. Documents for the procurement The firm has submitted the commercial invoice of the reference
of reference standard and standard and impurity standard purchased from different source
impurity standards. other then API manufacturer.
submitted.
submitted.
GMP Certificate No. SU20160171 issued by Jiangsu Food and
Drug Administration China, valid up to 31-december-2020 is
submitted.
6. Certificate of analysis of the Amlodipine as besylate API:
API, reference standards and Photocopy of COA of Batch No. AM0331216 issued by ―
impurity standards M/s Hetero Drugs Limited (Unit-IV), India‖ is submitted.

development?
Production Data
9. Authorized Protocols/SOP for The firm has submitted copy of SOP with the title
the development & stability ‗Protocols/standard operating procedure for the development of
testing of trial batches. Sofvasc trio tablet 20/5/12.5mg tablet‖
Trail#1 1500 Tabs 2-2018
Trail#2 1500 Tabs 2-2018
Trail#3 1500 Tabs 2-2018
11. Record of remaining quantities Trapeze plus XR ;
of stability batches. Stability Pack Size:
568 are remaining
568 are remaining
568 are remaining
QA/QC DATA
12.  Previously Reported in panel inspection:
Record of Digital data logger for
temperature and humidity
The firm has installed software for recording the
monitoring of stability chamberstemperature/Humidity of the chamber (for real time stability & for

Time).
15. Reports of stability studies of Amlodipine as besylate:
API from manufacturer. The firm has submitted copy of accelerated, 06 Months (40°C ±
studies. studies and refereed to the claimed that there composition is
same as innovators and refereed to hand book of excipient.
conducted on following dates:
following media:

Evaluation by PEC:

Qualification of qualified person not mentioned ------
COA of Impurity standard are not provided and some COA‘s of

standards were purchased from different manufacture (TRC, Synpure
labs, then the API manufacturer. Justify/clarify.
COA of Impurity standard of amlodipine are not provided same is ------
required.
Decision: Registration Board after thorough deliberation deferred the case for scientific justification
of use of working standard from a manufacturer other than API manufacturer.
Case No. 06: Miscellaneous Cases:

1009. Name and address of manufacturer / M/s Aptly pharmaceuticals, 5 Km, Sargodha road Bypass,
Applicant Faisalabad
M/s Aptly Pharmaceuticals, 5-Km Sargodha-Sidhar Bypass Road, Faisalabad. (New License)
CLB in its 265th meeting held on 9th & 10th August, 2018 has considered and approved the grant of
Drug Manufacturing License (No.000887) by way of formulation with following five sections:
1. Oral Liquid (General) Veterinary section
2. Oral Liquid (General Antibiotic) Veterinary section
3. Oral Powder (General) Veterinary section
4. Oral Powder (General Antibiotic) Veterinary section
5. Oral Powder (Penicillin) Veterinary section (14 products/ 10 molecules)
Brand Name +Dosage Form + Strength Aoromox C-20 Powder
Diary No. Date of R& I & fee Dy.No.29934, 5-9-18, Rs. 20,000/-
Composition Each 100gm contain
Amoxicillin Trihydrate....25 gm
Colistin sulphat …80 MIU
Type of Form Form-5
Pack size & Demanded Price 500 gm, 1 kg, 2.5 kg, 5 kg
Decontrolled
Me-too status Colimoxin Forte Oral Dry Powder (080961)
GMP status Last GMP Inspection Conducted on 6 August 2018 with
conclusive remarks of good compliance for grant of drug
manufacturer license by way of formulation in respect to
following sections
 Oral liquid General
 Oral liquid antibiotic
 Oral powder general
 Oral powder antibiotic
 Oral powder penicillin
Decision of 285: Approved with innovators specifications
The Previous composition was different from Me too,
The firm now provide the form 5 in which the applied formulation is as under
Each 100gm contain
Colistin sulphat …80 MIU
Which is in line with Me too product:
Colimoxin Forte Oral Dry Powder of Salmore Pharma (080961)
Decision: Deferred for submission of full fee.
1010. Name and address of manufacturer / M/s Aptly pharmaceuticals, 5 Km, Sargodha road Bypass,
Applicant Faisalabad
Brand Name +Dosage Form + Strength Speclinomox Powder
Diary No. Date of R& I & fee Dy.No.29893, 5-9-18, Rs. 20,000/-
Composition Each kg contain
Spectinomicin sulphate.. 8.8 gm
Lincomycin HCL …...8.8 gm
Type of Form Form-5
Pack size & Demanded Price 500 gm, 1 kg, 2.5 kg, 5 kg
Decontrolled
Me-too status Linkomox Oral Powder. (048226)
Decision of 285: Approved with innovators specifications
The Previous composition was different from Me too,
The firm now provide the form 5 in which the applied formulation is as under
Each 100 gm contain
Spectinomicin sulphate.. 8.8 gm
Lincomycin HCL …...8.8 gm
Which is in line with Me too product:
Linkomox Oral Powder of Biogen Pharma (048226)
Decision: Deferred for submission of full fee.

Evaluator PEC-X
Case No. 01: Registration Aapplications of Newly Granted DML or New Section (Human)
a. M/s Perfect Pharma Pvt. Ltd. 5-km, Manga Road, Raiwind Lahore.
CLB in its 262nd meeting held 23-05-2018 has considered and approved the Tablet
(Psychotropic) section. The details of molecules and products applied are as below:
Tablet (Psychotropic) Section : 10 molecules / 20 products
1011. Name and address of manufacturer / M/s Perfect Pharma Pvt. Ltd. 5-km, Manga Road, Raiwind
Applicant Lahore
Brand Name +Dosage Form + Strength Kalpax tablet 0.25mg
Composition Each tablet Contains:
Alprazolam…..0.25mg
Diary No. Date of R& I & fee Dy. No 10634 Dated 05-03-2019, Rs. 20,000/-
Pharmacological Group Benzodiazepine derivatives
Type of Form Form 5
Approval status of product in XANAX® Pharmacia & Upjohn Company LLC USA
Me-too status Leazam Tablet 0.25mg (Reg. 065304) of Leads Pharma
GMP status The firm was granted tablet (Psychotropic) section on the
recommendation of panel of expert on dated 26-06-2018
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Kalpax tablet 0.5mg
Alprazolam…..0.5mg
Type of Form Form 5
Me-too status Zanac 0.5mg Tablet (Reg. 058628) of Zanctok Pharma
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Kalpax tablet 1mg
Alprazolam…..1mg
Type of Form Form 5
Me-too status Lydia 1mg Tablet (Reg. 065699 ) of M/s. Wilshire Lab
GMP status The firm was granted tablet (Psychotropic) section on the
recommendation of panel of expert on dated 26-06-2018
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Kalpax tablet 2mg
Alprazolam…..2mg
Type of Form Form 5
Me-too status Onax 2 Tablet (Reg. 058450) of Safe Pharma
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Proraze tablet 1mg
Lorazepam…..1mg
Type of Form Form 5
Approval status of product in Ativan® C-IV of MEDA Manufacturing GmbH Cologne,
Reference Regulatory Authorities. Germany
Me-too status Veniti 1mg Tablet (Reg. 065694) of M/s. Wilshire Lab
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Proraze tablet 2mg
Lorazepam…..2mg
Type of Form Form 5
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Prodiaze tablet 2mg
Diazepam…..2mg
Type of Form Form 5
Approval status of product in DIAZEPAM TABLETS BP 2mg of Actavis UK Limited
Me-too status Anxosal 2mg Tablets (Reg. 064075) of Universal Pharma
Decision: Approved
Applicant Lahore
Diazepam…..5mg
Type of Form Form 5
Me-too status Rorpam 5mg Tablet (Reg. 080238) of Roryan Pharma
Decision: Approved
Applicant Lahore
Diazepam…..10mg
Type of Form Form 5
Me-too status Rorpam 10mg Tablet (Reg. 080239) of Roryan Pharma
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Clonamedics tablet 0.5mg
Clonazepam…..0.5mg
Type of Form Form 5
Approval status of product in KLONOPIN TABLETS (clonazepam) of Roche Pharma USA
Me-too status Clonazep 0.5 mg Tablets (Reg. 078588) of Roryan Pharma
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Clonamedics tablet 1mg
Clonazepam…..1mg
Type of Form Form 5
Me-too status Curo 1mg Tablets (Reg. 065700) of M/s. Wilshire Lab
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Clonamedics tablet 2mg
Clonazepam…..2mg
Type of Form Form 5
Me-too status Clonazep 2 mg Tablets (Reg. 078589) of Roryan Pharma
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Bromakal tablet 1.5mg
Bromazepam…..1.5mg
Pharmacological Group Anxiolytic agents
Type of Form Form 5
Finished Product Specification Innovator‘s specification
Approval status of product in Apo-Bromazepam 1.5mg of APOTEX INC.Toronto,
Me-too status E-Ze 1.5mg Tablet (Reg. 061254) of Genix Karachi
Decision: Approved with innovator‘s specification
Applicant Lahore
Brand Name +Dosage Form + Strength Bromakal tablet 3mg
Bromazepam…..3mg
Type of Form Form 5
Approval status of product in Apo-Bromazepam 3mg of APOTEX INC.Toronto,
Me-too status Yazd 3mg Tablet (Reg. 065692) of M/s. Wilshire Lab
Applicant Lahore
Brand Name +Dosage Form + Strength Bromakal tablet 6mg
Bromazepam…..6mg
Type of Form Form 5
Me-too status Tanil-6mg Tablet (Reg. 060760) of M/s Friends Pharma
Decision: Approved with innovators specification
Applicant Lahore
Brand Name +Dosage Form + Strength Paradeine tablet
Paracetamol….500mg
Codeine phosphate….15mg
Type of Form Form 5
Approval status of product in Co-codamol 15/500 Tablets of Zentiva Pharma UK Limited
Me-too status Lowmol Tablets (Reg. 040426) of Lowit Pharma (Pvt) Ltd.,
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Zolkalp tablet 10mg
Zolpidem tartrate…..10mg
Pharmacological Group Benzodiazepine derivatives (Sedative hypnotic)
Type of Form Form 5
Approval status of product in Zolpidem 10 mg Film-Coated Tablets of Generics [UK] Ltd t/a
Reference Regulatory Authorities. Mylan
Me-too status Somnia 10mg Tablets (Reg. 067737) of M/s. Wilshire Lab.
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Methylkal tablet 10mg
Methylphenidate hydrochloride…..10mg
Pharmacological Group Centrally acting sympathomimetics
Type of Form Form 5
Approval status of product in Medikinet® 10 mg tablet of MEDICE Arzneimittel Pütter GmbH
Reference Regulatory Authorities. & Co. KG Kuhloweg 37, 58638 Iserlohn, Germany
Me-too status Fanidan Tablet 10 mg (Reg. 066475) of Danas Pharma.
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Phenokal tablet 30mg
Phenobarbitone…..30mg
Pharmacological Group Antiepileptics
Type of Form Form 5
Approval status of product in PHENOBARBITAL ACCORD TABLETS BP 30mg of Accord-
Reference Regulatory Authorities. UK Ltd
Me-too status Phenotone Tablets (Reg. 065717) of M/s Rasco Pharma
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Midakal tablet 7.5mg
Midazolam…..7.5mg
Type of Form Form 5
Approval status of product in Dormicum 7.5 mg, film-coated tablets of Roche Nederland
Me-too status Phenotone Tablets (Reg. 065717) of M/s Rasco Pharma

M/s Hiranis Pharmaceuticals, Karachi .
CLB in its 269nd meeting held 26-02-2019 has considered and approved the Tablet
(Psychotropic) section. The details of molecules and products applied are as below:
Tablet (Psychotropic) Section: 9 molecules / 20 products
1031. Name and address of manufacturer / M/s Hiranis pharmaceuticals (Pvt.) Ltd. plot No. E-145 to E-149,
Applicant North Western Industrial Zone, port Qasim, Karachi
Brand Name +Dosage Form + Strength ANZILUM Tablet 0.25mg
Alprazolam………………0.25mg
Type of Form Form-5
Me-too status Leazam Tablet 0.25mg (Reg. 065304) of Leads Pharma
concludes that the firm is overall GMP compliant.
Decision: Approved
Brand Name +Dosage Form + Strength ANZILUM Tablet 0.5mg
Alprazolam………………0.5mg
Type of Form Form-5
Me-too status Zanac 0.5mg Tablet (Reg. 058628) of Zanctok Pharma
Decision: Approved
Brand Name +Dosage Form + Strength ANZILUM Tablet 1mg
Alprazolam………………1mg
Type of Form Form-5
Me-too status Lydia 1mg Tablet (Reg. 065699 ) of M/s. Wilshire Lab
Decision: Approved
Brand Name +Dosage Form + Strength ANZILUM Tablet 2mg
Alprazolam………………2mg
Type of Form Form-5
Me-too status Onax 2 Tablet (Reg. 058450) of Safe Pharma
Decision: Approved
1035. Name and address of manufacturer / M/s Hiranis pharmaceuticals (Pvt.) Ltd. plot No.E-145 to E-149,
Brand Name+Dosage Form+Strength Lonza Tablet 0.5mg
Lorazepam………………0.5mg
Type of Form Form-5
Me-too status Veniti 0.5mg Tablet (Reg. 071220) of M/s. Wilshire Lab
Decision: Approved
Brand Name+Dosage Form+Strength Lonza Tablet 1mg
Lorazepam………………1mg
Type of Form Form-5
Decision: Approved
Brand Name+Dosage Form+Strength Lonza Tablet 2mg
Lorazepam………………2mg
Type of Form Form-5
th
Decision: Approved
Brand Name +Dosage Form + Strength Somno Tablet 5mg
Zolpidem Tartrate ……… 5mg
Type of Form Form-5
Approval status of product in Ambien of Sanofi Aventis, USFDA
Me-too status Demtrat Tablet 5mg of Bosch (Reg 061072)
Decision: Approved
Brand Name +Dosage Form + Strength Somno Tablet 10mg
Zolpidem Tartrate ……… 10mg
Type of Form Form-5
Approval status of product in Ambien of Sanofi Aventis, USFDA
Me-too status Zolpidem 10mg Tablet (Reg. No. 061008) of Medimarker‘s
Hyderabad
Decision: Approved.
Brand Name +Dosage Form + Strength Mazinil Tablet 3mg
Bromazepam………………3mg
Pharmacological Group Anxiolytic
Type of Form Form-5
Me-too status Yazd 3mg Tablet (Reg. 065692) of M/s. Wilshire Lab

Brand Name +Dosage Form + Strength Mazinil Tablet 6mg
Bromazepam………………6mg
Pharmacological Group Anxiolytic
Type of Form Form-5
Me-too status Tanil-6mg Tablet (Reg. 060760) of M/s Friends Pharma
Brand Name +Dosage Form + Strength Clotril Tablet 0.5mg
Clonazepam………………0.5mg
Type of Form Form-5
Me-too status Clonazep 0.5 mg Tablets (Reg. 078588) of Roryan Pharma
Decision: Approved
Brand Name +Dosage Form + Strength Clotril Tablet 1mg
Clonazepam………………1mg
Type of Form Form-5
Me-too status Curo 1mg Tablets (Reg. 065700) of M/s. Wilshire Lab
Decision: Approved
Brand Name +Dosage Form + Strength Clotril Tablet 2mg
Clonazepam………………2mg
Type of Form Form-5
Me-too status Clonazep 2 mg Tablets (Reg. 078589) of Roryan Pharma
Decision: Approved
Brand Name +Dosage Form + Strength ESILGAN Tablet 1mg
Estazolam………………1mg
Type of Form Form-5
Approval status of product in Prosom Tab of Abbott, USFDA
Me-too status Esilgan Tablet 1mg of Helix (Reg#007480)
Brand Name +Dosage Form + Strength ESILGAN Tablet 2mg
Estazolam………………2mg
Type of Form Form-5
Approval status of product in Prosom Tab of Abbott, USFDA
Me-too status Esilgan Tablet 1mg of Helix (Reg#007480)
Brand Name +Dosage Form + Strength Slorit-D Tablet 2.5/120
Desloratadine………………2.5mg
Pseudoephedrine Sulfate…..120mg
(Extended Release)
Pharmacological Group Antihistamine/Sympathomimetic Amine
Type of Form Form-5
Approval status of product in CLARINEX-D of MSD, USFDA
Me-too status DESRHIN Tab of Atco (Reg#067246)
Decision: Deferred for evidence of approval of requisite manufacturing facility/section from licensing
division
Brand Name +Dosage Form + Strength Slorit-D Tablet 5/240
Desloratadine………………5mg
Pseudoephedrine Sulfate…..240mg
(Extended Release)
Pharmacological Group Antihistamine/Sympathomimetic Amine
Type of Form Form-5
Approval status of product in CLARINEX-D of MSD, USFDA
Me-too status DESRHIN Tab of Atco (Reg#067247)
division
Brand Name +Dosage Form + Strength Laderfex-D Tablet 60/120
Fexofendine HCl………….60mg
Pseudoephedrine HCl……..120mg
(Extended Release)
Pharmacological Group Antihistamine/Sympathomimetic
Type of Form Form-5
Approval status of product in ALLEGRA-D Tab of Sanofi Aventis, USFDA
Me-too status Fenadrin D Tablet of Noa Hemis (Reg#042352)
division
Brand Name +Dosage Form + Strength Hirafen-Plus Tablet 200mg/30mg
Ibuprofen……………………200mg
Pseudoephedrine HCl………..30mg
Pharmacological Group NSAID/Sympathomimetic
Type of Form Form-5
Approval status of product in Advil Cold and Sinus of Pfizer, USFDA
Me-too status Rovinac Tablets of Rock Pharma (Reg# 064206)

division
M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207, Industrial Triangle Kahuta Road
Islamabad
CLB in its 267th meeting held 31-12-2018 has considered and approved the one additional
section of Liquid vial SVP (X-ray contrast media) Section. The details of molecules and products
applied are as below:
Liquid Vial SVP (X-ray Contrast Media)
08 Products / 05 molecules
Brand Name +Dosage Form + Strength Gadomag Injection
Composition Each ml vial Contains:
Gadopenteate dimeglumine………….0.469g
Pharmacological Group Radiopaque diagnostic agent
Type of Form Form 5
Pack size & Demanded Price 10ml, 15ml, 20ml & 100ml vial / MRP. Rs. As per SRO
Approval status of product in MAGNEVIST (GADOPENTETATE DIMEGLUMINE) of Bayer
Reference Regulatory Authorities. HealthCare Pharmaceuticals
Me-too status Omnivist 10ml Injection. Each Ml Contains:-
Gadopentetate Dimeglumine 469mg Of Graton Pharma, Karachi.
GMP status New section for Liquid vial SVP( X-ray contrast media) letter
issued by DRAP dated 17th January 2019
Decision: Approved
Brand Name +Dosage Form + Strength Uroimag 76% injection
Amidotrizoate meglumine ………… 660mg
Sodium amidotrizoate …………………. 100mg
Pharmacological Group Diagnostic contrast media
Type of Form Form 5
Finished Product Specification Rotex Specs.
Pack size & Demanded Price Pack of 20‘s, 50‘s & 100‘s / MRP. Rs. As per SRO
Approval status of product in UROGRAFIN of Bayer plc 400 South Oak Way
Me-too status
Brand Name +Dosage Form + Strength Ioimag – 300 Injection
Composition Each ml contains 612mg Iopamidol equivalent to 300mg of iodine
per ml.
Type of Form Form 5
Pack size & Demanded Price Pack of 20ml, 50ml & 100ml / MRP. Rs. As per SRO
Approval status of product in NIOPAM 300, solution for injection of Bracco Imaging spa. Via
Reference Regulatory Authorities. Egidio Folli 50 20134 Milano - Italy
Me-too status SCANLUX 300MG/ML SOLUTION FOR INJECTION of M/s
HAJI MEDICINE CO., RAWALPINDI
Decision: Approved
Brand Name +Dosage Form + Strength Ioimag – 370 Injection
Composition Each ml contains 755mg Iopamidol equivalent to 370mg of iodine
per ml.
Type of Form Form 5
Pack size & Demanded Price Pack of 20ml, 50ml & 100ml
MRP. Rs. As per SRO
Approval status of product in NIOPAM 370, solution for injection of Bracco Imaging spa Via
Reference Regulatory Authorities. Egidio Folli 50 20134 Milano – Italy
Me-too status Pamiray 370 inj. Of Al-Habib Pharma Karachi
Decision: Approved
Brand Name +Dosage Form + Strength Iovist -300 Injection
Composition Each ml contains 623mg Iopromide equivalent to 300mg of Iodine
per ml
Type of Form Form 5
MRP. Rs. As per SRO
Approval status of product in Ultravist -300 Injection of Bayer Health Care Germany
Me-too status Ultravist-300 Injection Contains:
Iopromide…0.623gm of M/s Ali Gohar & Co. Karachi
Decision: Approved
Brand Name +Dosage Form + Strength Iovist -370 Injection
Composition Each ml contains 768.86mg Iopromide equivalent to 370mg of
Iodine per ml
Type of Form Form 5
Pack size & Demanded Price Pack of 20ml, 50ml & 100ml / MRP. Rs. As per SRO
Approval status of product in Ultravist -370 Injection of Bayer Health Care Germany
Me-too status Ultravist 370 Injectioncontains: - IOPROMIDE…0.769gm of
M/s ALI GOHAR & CO KARACHI

Decision: Approved
Brand Name +Dosage Form + Strength Hexoimag-300 Injection
Composition Each ml contains 647mg Iohexol equivalent to 300mg of Iodine
per ml
Type of Form Form 5
MRP. Rs. As per SRO
Approval status of product in Omnipaque -300 inj. GE Healthcare Ireland Limited, Cork,
Reference Regulatory Authorities. Ireland
Me-too status OMNIPAQUE INJECTION 300MG/MLCONTAINS: -
IOHEXOL 647.1MG of M/s APEX PVT LTD KARACHI
Decision: Approved
Brand Name +Dosage Form + Strength Hexoimag-350 Injection
Composition Each ml contains 755mg Iohexol equivalent to 350mg of Iodine
per ml
Type of Form Form 5
MRP. Rs. As per SRO
Approval status of product in Omnipaque -350 inj. GE Healthcare Ireland Limited, Cork,
Me-too status Monopaque 350mg/ml Injection of Graton Pharma,
Decision: Approved
M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207, Industrial Triangle Kahuta Road
Islamabad (duplicate dossier)
New Section for sterile dry powder vial and sterile liquid ampoule (Steroid) inspected by panel
of expert on dated 19th Sep. 2018 and panel recommended the grant of applied new/additional
sections.
Liquid Ampoule (Steroid)
5 products/ 4 molecules
Brand Name +Dosage Form + Strength DEPO-MED 40MG/ML INJECTION
Composition Each 1ml Ampoule Contains;
Methylprednisolone acetate …………40mg
Diary No. Date of R& I & fee Dy. No 4339 Dated 23-04-2019, Rs. 20,000/- dated 04-12-2018
Pharmacological Group Glucocorticoid
Type of Form Form 5

Pack size & Demanded Price 1 Amp x 1ml / MRP As per SRO
Approval status of product in Depo-Medrone Injection 40mg/1ml by M/s Pfizer Limited
Me-too status Co-Sterol Injection of Cirin Pharma (63094)
GMP status New Section for sterile dry powder vial and sterile liquid
ampoule (Steroid) inspected by panel of expert on dated 19th Sep.
2018 and panel recommended the grant of applied section.
Decision: Approved with change in brand name
Brand Name +Dosage Form + Strength DEPO-MED 80MG/2ML INJECTION
Methylprednisolone acetate ……80mg

Type of Form Form 5
Pack size & Demanded Price 1 Amp x 2ml / MRP. Rs. As per SRO
Approval status of product in Depo-Medrone Injection 80mg/2ml by M/s Pfizer Limited
Me-too status ROTAPRED DEPOT INJECTION 80MG of ROTEX (12174)
Brand Name +Dosage Form + Strength TRIMACORT 40MG INJECTION
Triamcinolone acetonide …………40mg
Type of Form Form 5
Pack size & Demanded Price 1 Amp x1ml / MRP. Rs. As per SRO
Approval status of product in KENACORT A40 triamcinolone acetonide 40mg/1ml injection
Reference Regulatory Authorities. ampoule by M/s Aspen Pharma (Pvt) Ltd (TGA Approved)
Me-too status Lisanolona 40mg/1ml injection (ampoule) by M/s Mehran
International (Reg. # 039871)
Brand Name +Dosage Form + Strength DEPO MEDROX 150MG/ML INJECTION
Medroxyprogesterone acetate ………….150mg
Pharmacological Group Synthetic progestogen
Type of Form Form 5
Pack size & Demanded Price 1 Amp x1ml / MRP. Rs. As per SRO
Approval status of product in Depo-Provera (1ml) 150mg/1ml Sterile Suspension for injection
Reference Regulatory Authorities. (1ml) by M/s Pfizer, UK (MHRA Approved)
Me-too status MEGESTRON INJ of ORGANON (Reg. 12656)
Brand Name +Dosage Form + Strength DEXASONE 4MG/ML INJECTION
Dexamethasone phosphate (as sodium) ………4mg
Diary No. Date of R& I & fee Dy. No 4337 Dated 23-04-2019, Rs. 20,000/- 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 25‘s Ampoule x 1ml / MRP. Rs. As per SRO
Approval status of product in DBL DEXAMETHASONE SODIUM PHOSPHATE
Reference Regulatory Authorities. INJECTION 4mg/ml (as sodium) Injection Ampoule by M/s
Hospira Australia Pvt Ltd
Me-too status D.Dron Injection of Epharm Laboratories (Reg. 058424)
Decision: Approved
REGAL Pharmaceuticals, Islamabad.

The CLB in its 269th meeting held on 26.02.2019 granted three additional section to the firm.
The details of molecules and products applied are as below:
Dry Suspension Section (Cephalosporin): 7 molecules/ 13 Products
1064. Name and address of manufacturer / Regal. Pharmaceuticals, Plot No 2-A, Street No. S-5 National
Applicant Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength ZOLEX 125mg/5ml Dry Suspension
Composition Each 5ml after reconstitution contains:
Cephalexin Monohydrate eq to Cephalexin USP… 125mg
Diary No. Date of R& I & fee Diary No 15108 Dated 07/03/2019, Rs 20000/- , Dated 06/03/2019
Pharmacological Group Cephalosporine Antibiotic
Type of Form Form 5
Pack size & Demanded Price 60 ml ; and Price as per Policy
Approval status of product in Cefalexin 125mg/5ml Powder for Oral Suspension of M/s
Reference Regulatory Authorities. Milpharm Limited UK
Me-too status AG-CIN 125mg Dry Suspension (Saydon Pharma)
GMP status Grant of Additional Sections by CLB in its 269th meeting dated
26th Feb. 2019 are as under:
1. Capsule Section (Cephalosporin)
2. Dry Suspension Section (Cephalosporin)
3. Dry Powder vial Injection (Cephalosporin)
Brand Name +Dosage Form + Strength ZOLEX 250mg/5ml Dry Suspension

Type of Form Form 5
Approval status of product in Cefalexin 250mg/5ml Powder for Oral Suspension of M/s
Reference Regulatory Authorities. Milpharm Limited UK
Me-too status AG-CIN 250mg Dry Suspension (Saydon Pharma)
Brand Name +Dosage Form + Strength CEFIX 100mg/5ml Dry Suspension
Composition Each 5ml contains after reconstitution:
Cefixime trihydrate eq to cefixime USP…. 100 mg.
Diary No. Date of R& I & fee Diary No 15103, Dated 07/03/2019, Rs 20000/- Dated 06/03/2019
Type of Form Form 5
Pack size & Demanded Price 30ml; and Price as per Policy
Approval status of product in Cefixime 100 mg/5 ml granules for oral suspension (MHRA)
Me-too status EPAN 100mg/5ml Dry suspension (EPHARM Labs)
Brand Name +Dosage Form + Strength CEFIX 200mg/5ml Dry Suspension
Cefixime trihydrate eq to cefixime……. 200 mg.
Pharmacological Group Cephalosporine antibiotic
Type of Form Form 5
Approval status of product in Cefixime for Oral Suspension of Aurobindo Pharma USA, Inc. U.
Me-too status EPAN 200mg/5ml Dry suspension (EPHARM Labs)
Brand Name +Dosage Form + Strength Reclor 125mg/5ml Dry Suspension
Cefaclor monohydrate USP………. 125 mg.
Type of Form Form 5
Finished Product Specification USP. Specification
Approval status of product in 125mg/5ml SUSPENSION (cefaclor) (MHRA)
Me-too status CECLOR 125mg/5ml ELI LILLY (Reg. 007176)
Brand Name +Dosage Form + Strength Reclor 250mg/5ml Dry Suspension
Cefaclor as monohydrate ………. 250 mg.
Type of Form Form 5
Approval status of product in 250mg/5ml SUSPENSION (cefaclor) (MHRA)
Me-too status CECLOR 125mg/5ml ELI LILLY (Reg. 007175)
Brand Name +Dosage Form + Strength Prolix 40mg/5ml Dry Suspension
Cefpodoxime proxetil eq to Cefpodoxime USP ….. 40mg.
Type of Form Form 5
Finished Product Specification USP Specification
Pack size & Demanded Price 30ml and Price as per Policy
Approval status of product in Cefpodoxime 40 mg/5 ml granules for oral suspension of
Reference Regulatory Authorities. Milpharm Limited Ares, Odyssey Business Park West End Road
South Ruislip HA4 6QD United Kingdom
Me-too status Podicef 40mg/5ml Dry Suspension of Mediate Pharma
(R.#057919)
Applicant Industrial Zone, Rawat, Islamabad
Cefpodoxime proxetil eq to Cefpodoxime USP ….. 50mg.
Diary No. Date of R& I & fee Diary No 15110 Dated 07/03/2019, Rs 20000/- Dated 07/03/2019
Pharmacological Group Cephalosporine Antibiotics
Type of Form Form 5
Approval status of product in cefpodoxime proxetil eq 50mg base/5ml of pharmacia and upjohn
Reference Regulatory Authorities. USFDA
Me-too status Qink 50mg/5ml Dry Suspension(Wilshire Labs)
Brand Name +Dosage Form + Strength Recef 250mg/5ml Dry Suspension
Cephradine as monohydrate eq to cephradine USP ….. 250mg.
Type of Form Form 5
Pack size & Demanded Price Price as per Policy
Approval status of product in VELOSEF '250' of APOTHECON (USFDA)
Me-too status VELOSEF 250MG sus. (Reg. 1868) by Gsk
Brand Name +Dosage Form + Strength NEROX 125mg/5ml Dry Suspension
Cefadroxil Monohydrate USP eq to Cefadroxil ……… 125mg
Type of Form Form 5
Approval status of product in CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 125MG
Reference Regulatory Authorities. BASE/5ML of APOTHECON
Me-too status Evacef Suspension 125mg of Highnoon Lab (Reg 11213)
Brand Name +Dosage Form + Strength NEROX 250mg/5ml Dry Suspension
Cefadroxil Monohydrate USP eq to Cefadroxil……… 250mg
Type of Form Form 5
Approval status of product in Cefadroxil 250 mg/5 ml granules for oral suspension (MHRA)
Me-too status Evacef Suspension 250mg of Highnoon Lab (Reg. 11214)
Brand Name +Dosage Form + Strength CEFTEN 90mg/5ml Dry Suspension
Ceftibuten as dihydrate ………. 90 mg.
Type of Form Form 5
Finished Product Specification As per Innovator
Approval status of product in CEDAX 90mg/5ml
th
Reference Regulatory Authorities. (Schering Corporation Miami Lakes, FL 33014, USA)
Me-too status XIGRIS 90mg/5ml Dry suspension (Wilshire Labs)
 Decision: Approved with innovator‘s specification
Cefpodoxime proxetil eq to cefpodoxime ….. 100mg.
Type of Form Form 5
Approval status of product in CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR
Reference Regulatory Authorities. SUSPENSION;ORAL (USFDA)
Me-too status Qink 100mg/5ml Dry Suspension(Wilshire Labs)
REGAL. Pharmaceuticals, Islamabad.

The CLB in its 269th meeting held on 26.02.2019 granted three additional section to the firm.
The details of molecules and products applied are as below:
Capsule Section (Cephalosporin):
6 molecules/ 10 Products
Brand Name +Dosage Form + Strength Ceften 400mg Capsules
Ceftibuten as Dihydrate ……. 400mg.
Diary No. Date of R& I & fee Diary No 15076, Dated 07/03/2019, Rs 20000/-, Dated 07/03/2019
Pharmacological Group Cephalosporine
Type of Form Form 5
Finished Product Specification As per innovator
Pack size & Demanded Price 10 Capsules and Price as per Policy
Approval status of product in CEFTIBUTEN DIHYDRATE EQ 400MG BASE of SI PHARMS
Me-too status Xigris Capsule 400mg capsule Wilshire Lab
 Decision: Approved with innovator‘s specification
Brand Name +Dosage Form + Strength Reclor 250mg Capsule
Cefaclor USP ….. 250mg.
Diary No. Date of R& I & fee Diary No 15118, Dated 07/03/2019, Rs 20000/-, Dated 07/03/2019
Type of Form Form 5
Pack size & Demanded Price 12‘s Blister and Price as per Policy
Approval status of product in CEFACLOR EQ 250MG BASE of LILLY USFDA
Me-too status U-Saclor 250 mg Capsules of Usawa (Reg. 76821)
Brand Name +Dosage Form + Strength Reclor 500mg Capsule
Cefaclor as monohydrate ….. 500mg.
Type of Form Form 5
Pack size & Demanded Price 12‘s Blister Capsule, Price as per Policy.
Approval status of product in CEFACLOR EQ 500MG BASE of LILLY USFDA
Me-too status U-Saclor 500 mg Capsules of Usawa (Reg. 76822)
Brand Name +Dosage Form + Strength ZOLEX 250mg Capsule
Type of Form Form 5
Pack size & Demanded Price 12‘s & 10‘s Capsules/Blister and Price as per Policy
Approval status of product in CEPHALEXIN EQ 250MG BASE of BELCHER PHARMS
Me-too status Vegzin Capsules of Vega Pharma (Reg. 78693)
Brand Name +Dosage Form + Strength ZOLEX 500mg Capsule
Type of Form Form 5
Pack size & Demanded Price 12‘s & 10‘s Capsules/Blister and Price as per Policy
Approval status of product in CEPHALEXIN EQ 500MG BASE of BELCHER PHARMS
Me-too status Vegzin Capsules of Vega Pharma (Reg. 78694)
Brand Name +Dosage Form + Strength CEFIX 200mg Capsule
Cefixime trihydrate eq to cefixime………. 200 mg.
Type of Form Form 5
Finished Product Specification JP Specification
Pack size & Demanded Price 5 Capsules/Blister & Price as per Policy
Approval status of product in Cefixima Normon 200 mg cápsulas of Laboratorios Normon, S.A.
Reference Regulatory Authorities. (Spanish medicine agency approved)
Me-too status Soxime 200mg Capsule of Swat Pharma (Reg. 060127)
Brand Name +Dosage Form + Strength CEFIX 400mg Capsule
Cefixime trihydrate eq to cefixime………. 400 mg.
Pharmacological Group Cephalosporine Antibiotics
Type of Form Form 5
Finished Product Specification JP Specification
Pack size & Demanded Price 5 Capsules/Blister and Price as per Policy
Approval status of product in CEFIXIME 400MG capsule ALKEM LABS LTD USFDA
Me-too status Cefim Capsule 400mg of Hilton Pharma (19818)
Brand Name +Dosage Form + Strength Recef 250mg Capsule
Cephradine as monohydrate eq to cephradine USP….. 250mg.
Type of Form Form 5
Pack size & Demanded Price 12‘s capsule/Blister Price as per Policy
Approval status of product in Cefradine 250mg Capsules (Athlone Pharmaceuticals Limited
Me-too status SN Sef 250mg Capsules of SNB Pharma (Pvt) Ltd (Reg. 77500)
Brand Name +Dosage Form + Strength Recef 500mg Capsule
Cephradine as monohydrate eq to cephradine USP….. 500mg.
Type of Form Form 5
Pack size & Demanded Price 12‘s Capsule/Blister, Price as per Policy
Approval status of product in Cefradine 500mg Capsules (Athlone Pharmaceuticals Limited
Me-too status Velo 500 mg Capsule of Linta Pharmaceutics (Reg. 78187)
Brand Name +Dosage Form + Strength NEROX 500mg Capsule
Cefadroxil Monohydrate USP eq to Cefadroxil……… 500mg
Type of Form Form 5
Pack size & Demanded Price 12‘s & 10‘s Capsules and Price as per Policy
Approval status of product in Cefadroxil 500 mg Capsules (MHRA)
Me-too status Gabadrox 500mg Capsule of Gaba PharmaKar (Reg. 76273)
M/s Novex Pharmaceuticals, Plot No 54, S6 National Industrial Zone Rawat Islamabad
(New License)
Drug Manufacturing License (DML) to issue to M/s Novex Pharaceuticals by way of
formulation and granted (04) new section to the firm. Accordingly, firm has applied for
following products for consideration by Drug Registration Board.
Eye Drops Section
04 Products/04 Molecules
1087. Name and address of Manufacturer / M/s Novex Phamaceuticals, Plot No 54, S6 National Industrial
Applicant Zone Rawat Islamabad
Brand Name + Dosage Form + Strength Novoprost 0.005% w/v Opthalmic Solution
Composition 2.5ml Opthalmic Solution contains:
Latanoprost…………………..….125µg.
Diary No, Date of R & I & fee Dy. No. 13678 dated 07-03-19 Rs20,000/-Dated 07-03-19
Pharmacological Group Prostaglandins
Type of Form Form-5
Approval Status of product in Reference Xalatan 50 micrograms/ml eye drops solution
Regulatory Authorities. Pfizer Limited
Me-too status Hilatan M/s Himont Pharmaceuticals (Pvt) Ltd
GMP Status Panel inspection conducted on 12-02-2019 & 21-02-2019, and
the report concludes that the panel unanimously Recommended
M/s Novex Pharmaceuticals for the grant of DML for the
following section:
1. Sterile SVP Liquid Infusion vial (General)
2. Sterile Liquid Ampoule (General)
3. Sterile Liquid Ampoule (Steroid)
4. Sterile Eye/Ear/Nasal Preparations (Steroid)
Decision: Approved
Brand Name + Dosage Form + Strength Moxoflow 0.5% Sterile Ophthalmic Solution
Composition Each ml Opthalmic Solution contains:
Moxifloxacin Hydrochloride 5.45mg equivalent to
Moxifloxacin…………..….5mg.
Diary No, Date of R & I & fee Dy. No 13667 dated 07-03-19 Rs20,000/-Dated 07-03-19
Pharmacological Group Quinolone antibiotic
Type of Form Form-5
Approval Status of product in Reference Moxivig 0.5%w/v Eye Drops, Solution
Regulatory Authorities. Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited
Me-too status A-Mox of M/S Atco Laboratories Ltd
Decision: Deferred for evidence of approval of requisite manufacturing facility from licensing division
since the firm has Sterile Eye/Ear/Nasal Preparations (Steroid) section
Brand Name + Dosage Form + Strength Nobradex Sterile Ophthalmic Suspension
Composition Each ml Ophthalmic Solution contains:
Tobramycin …………………..….3 mg.
Dexamethasone ………………...1 mg
Diary No, Date of R & I & fee Dy. No. 13668 dated 07-03-19 Rs 20,000/-Dated 07-03-19
Pharmacological Group Water-Soluble Aminoglycoside Antibiotic
Type of Form Form-5
Approval Status of product in Reference TOBRADEX 3mg/ml/1mg/ml Eye Drops, Suspension
Me-too status Bracin D Sterile Ophthalmic Suspension (Reg. 30904) of Atco.
Decision: Approved
Brand Name + Dosage Form + Strength Novaket 0.5% w/v Ophthalmic Solution
Composition Each ml Opthalmic Solution contains:
Ketorolac Tromethamine ……………..….5mg.
Type of Form Form-5
Approval Status of product in Reference Acular Allergan Ltd. United Kingdom
Me-too status Kats Sterile Ophthalmic Solution of Medicaids (Pak) (R#058072)
Decision: Deferred for evidence of approval of requisite manufacturing facility from licensing division
since the firm has Sterile Eye/Ear/Nasal Preparations (Steroid) section
Sterile Liquid Ampoule (Steroid)
6 Products/ 6 Molecules
1091. Name and address of Manufacturer / M/s Novex Pharmaceuticlas, Plot No 54, S6 National Industrial
Brand Name + Dosage Form + Strength Dexalon 4mg/ml Injection
Dexamethasone as sodium phosphate…….4mg
Pharmacological Group Glucocorticosteroid
Type of Form Form-5
Approval Status of product in Reference Decadron Injection Merck Pharma
Me-too status DECADRON INJ 4MG/ML of Merck Sharp
Decision: Approved
Brand Name + Dosage Form + Strength Novalon 4mg/ml Injection
Betamethasone as sodium phosphate…….4mg
Type of Form Form-5
Approval Status of product in Reference Betamethasone Injection RPH Pharmaceutical Sweden
Me-too status Benate Injection, M/s Neutro Pharma (Reg. 044617)
Decision: Approved
Brand Name + Dosage Form + Strength Progest 250mg/ml Injection
Progestrone……..250mg
Pharmacological Group Hormone
Type of Form Form-5
Finished Product Specification In-house
Approval Status of product in Reference
Me-too status
Remarks of the Evaluator i. Approval Status of product in Reference Regulatory
Authorities is not confirmed.
ii. Generic/me-too) not confirmed from available data.
were adopted by the Registration Board
Brand Name + Dosage Form + Strength Novacort 40mg/ml Injection
Triamcinolone Acetonide……..40mg
Type of Form Form-5
Approval Status of product in Reference Kenalog Injection Apothecon Pharma Inc.
Regulatory Authorities. USA
Me-too status Danacort 40mg/ml Injection of M/S Danas Pharma (R.#081431)
Decision: Approved
Brand Name + Dosage Form + Strength Nedrol 40mg/ml Injection
Methylprednisolone Acetate……..40mg
Type of Form Form-5
Approval Status of product in Reference Depo-Medrol Injection
Regulatory Authorities. Pfizer New York
Me-too status DEPOMEDROL 40MG INJ Of KURRAM IBD
Decision: Approved
Brand Name + Dosage Form + Strength Testone 250mg Injection
Testosterone Propionate ……….….250mg
Pharmacological Group anabolic Steroid
Type of Form Form-5
Approval Status of product in Reference Sustanon 250 is a solution in oil. Each ampoule contains 1 ml
Regulatory Authorities. arachis oil containing the following active substances:
- 30 mg Testosterone propionate
- 60 mg Testosterone phenylpropionate
- 60 mg Testosterone isocaproate
- 100 mg Testosterone decanoate
Me-too status
Sterile Liquid Ampoule (General)
Brand Name + Dosage Form + Strength Nofever 150mg/5ml Injection
Composition Each ml ampoule contains:

Paracetamol ………..150mg
Diary No, Date of R & I & fee Dy. No. 14864 dated 07-03-19 Rs 20,000/-Dated 06-03-19
Pharmacological Group Analgesic & antipyretic
Type of Form Form-5
Me-too status
Brand Name + Dosage Form + Strength Gentox 80mg/2ml Injection
Gentamycin as sulfate…………….80mg
Type of Form Form-5
Finished Product Specification
Me-too status Lirin 80mg Injection of Zinta Pharma (Reg. 040098)
Remarks of the Evaluator Approval Status of product in Reference Regulatory Authorities
is not confirmed.
Brand Name + Dosage Form + Strength Nalfin 10mg Injection
Nalbuphine HCl ………..10mg
Type of Form Form-5
Approval Status of product in Reference Nubain Injection Par Pharm Inc
Me-too status Nalfy Injection of M/s Vision Pharma (Reg. 081912)
Decision: Approved
Brand Name + Dosage Form + Strength Renox 25mg Injection
Ranitidine HCl ………..25mg
Type of Form Form-5
Approval Status of product in Reference Zantac Injection Teligent Pharm Inc USA
Me-too status
Remarks of the Evaluator i. Composition showed that API is Nalbuphine HCL
whereas applied product is Ranitidine HCL.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along
with registration number, brand name and name of firm
 Composition showed that API is Nalbuphine HCL whereas applied product is Ranitidine HCL
clarify.
Brand Name + Dosage Form + Strength Mecob 500mcg Injection
Mecobalamin ………..500mcg
Type of Form Form-5
Approval Status of product in Reference Methycobal (PMDA)
Me-too status Neucobal Inj. (Reg. 074370)
Decision: Approved
Brand Name + Dosage Form + Strength Novex-D Injection
Cholecalciferol ………..5mg
Pharmacological Group Vitamin D3
Type of Form Form-5
Approval Status of product in Reference Vitamin D3 Good (ANSM)
Me-too status Genvit-D 5mg Injection (Reg. 61284)
Decision: Approved
Brand Name + Dosage Form + Strength Novatral 75mg/3ml Injection
Diclofenac sodium ………..75mg
Type of Form Form-5
Finished Product Specification Innovator‘s Specificatios
Approval Status of product in Reference DICLOFENAC 75MG/3ML SOLUTION FOR INJECTION
Regulatory Authorities. (MHRA)
Me-too status ANAFENAX INJECTION 75MG (Reg. 10019)
Decision: Approved
Brand Name + Dosage Form + Strength Novil 22.75mg/ml Injection
Pheniramine Maleate….22.75mg
Pharmacological Group Anti-Histamine
Type of Form Form-5
Me-too status Avil (Reg. 000226)
Brand Name + Dosage Form + Strength TRAMOX Injection
Tramadol HCl ………..100mg
Pharmacological Group Opioid Analgesic
Type of Form Form-5
Approval Status of product in Reference Zydol Injection Grünenthal Ltd. United Kingdom
Me-too status Zultra Injection (Reg. 80059)
Decision: Approved
Brand Name + Dosage Form + Strength Novecin 300mg Injection IV/IM
Lincomycin as HCl ………..300mg
Pharmacological Group Lincosamide antibiotic
Type of Form Form-5
Approval Status of product in Reference Lincomycin Injection
Regulatory Authorities. X-Gen Pharma Inc USA
Me-too status Mahacin Injection M/s Humayun International Pharma (Pvt) Ltd,
20 K M Satiana Road, Faisalabad
Remarks of the Evaluator Covering letter showing that applied product is
methylprednisolone acetate) whereas in form-5A it is
Lincomycin.
Decision: Deferred due to Covering letter showing that applied product is methylprednisolone acetate)
whereas in form-5A it is Lincomycin clarify.
Brand Name + Dosage Form + Strength Novafer 100mg/5ml Injection
Iron sucrose complex ………..100mg
Type of Form Form-5
Approval Status of product in Reference Vonefer Injection Vifor France.
Me-too status
Remarks of the Evaluator i. Composition submitted in form-5A shows paracetamol
whereas covering letter shows Iron sucrose complex.
 Incorrect composition.
Sterile SVP Liquid Infusion vial (General)
8 Molecules / 9 Products
Brand Name + Dosage Form + Strength Metox 500mg/100ml Injection
Composition Each 100ml vial contains:
Metronidazole……….500mg
Pharmacological Group nitroimidazoles (Amoebicides)
Type of Form Form-5
Pack Size & Demanded Price 100ml x1s (100ml Vial for injection) or , As per SRO
Approval Status of product in Reference Metronidazole 500 mg / 100 ml Intravenous Infusion by Baxter
Regulatory Authorities. Healthcare Ltd UK
Me-too status Lomizole Infusion 500mg of Llyods Pharmaceutical (R.#032001)
Decision: Approved
Paracetamol……..….1000mg
Pharmacological Group analgesics and antipyretics

Type of Form Form-5
Pack Size & Demanded Price 100ml x1‘s, As per SRO
Approval Status of product in Reference Paraceatmol Injection
Regulatory Authorities. Accord Healthcare Ltd UK (UK emc Approved)
Me-too status Paedal Infusion of M/s Regal Pharmaceuticals
Decision: Approved
Paracetamol……..….500mg
Pharmacological Group analgesics and antipyretics
Type of Form Form-5
Pack Size & Demanded Price 50ml x1‘s , As per SRO
Approval Status of product in Reference Paracetamol Injection
Regulatory Authorities. Accord Healthcare Ltd UK (UK emc Approved)
Me-too status
Remarks of the Evaluator Generic/me-too) not confirmed from available data.
Brand Name + Dosage Form + Strength NS 0.9% Injection
Composition Each 100ml injection contains:
Sodium chloride….0.9g
Type of Form Form-5
Finished Product Specification B.P Specifications
Pack Size & Demanded Price 100ml infusion, As per SRO
Approval Status of product in Reference Sodium Chloride 0.9% Intravenous Infusion BP of Baxter
Regulatory Authorities. Healthcare Ltd.
Caxton Way, Thetford
Norfolk IP24 3SE
United Kingdom
Me-too status 0.9% Sodium Chloride of Martin Dow Karachi (Reg. 021038)
Decision: Approved
Brand Name + Dosage Form + Strength Oflovex 200mg/100ml Injection
Ofloxacin……….200mg
Type of Form Form-5
Approval Status of product in Reference Tarivid Injection Sanofi-aventis Pharms
Me-too status Satacin Infusion I.V Injection (Reg. 71286) of Satum
Decision: Approved
Brand Name + Dosage Form + Strength Novecip 200mg/100ml Infusion
Ciprofloxacin…..….200mg
Type of Form Form-5
Pack Size & Demanded Price 100ml x1‘s, As per SRO
Approval Status of product in Reference Ciprofloxacin 2 mg/ml solution for infusion
Regulatory Authorities. of Hikma Farmacêutica (Portugal), S.A UK.
Me-too status Efecip Infusion 200mg/100ml of Genix Karachi (Reg. 073466)
Decision: Approved
Brand Name + Dosage Form + Strength Levonox 500mg/100ml Infusion
Levofloxacin as Hemihydrate…..….500mg
Type of Form Form-5
Approval Status of product in Reference Levofloxacin 5 mg/ml Solution for Infusion of Hospira UK
Regulatory Authorities. Limited
Me-too status Myroleve 500mg/100ml Infusion of Myrtle Pharma Karachi
(Reg. 070629)
Decision: Approved
Brand Name + Dosage Form + Strength Flucoz 200mg/100ml Injection
Fluconazole……..….200mg
Type of Form Form-5
Approval Status of product in Reference Diflucon 200mg/100ml Injection Pfizer Pharms
Me-too status
Remarks of the Evaluator Generic/me-too) not confirmed from available data.
Brand Name + Dosage Form + Strength Novemox 400mg/250ml Infusion
Composition Each 250ml infection contains:
Moxifloxacin as HCl……….400mg
Type of Form Form-5
Pack Size & Demanded Price 1s (250 Vial for injection) or , As per SRO
Approval Status of product in Reference Avelox 400 mg/250 ml solution for infusion of Bayer plc, 400
Regulatory Authorities. South Oak Way UK
Me-too status Moximed 400mg /250ml Infusion of Medimarker‘s Hyderabad
(Reg. 061020)
Decision: Approved
Case no. 06 Registration Applications of Import Cases:

a. New cases
M/s Servier Research and Pharmaceuticals (Pakistan) Lahore applied following imported human
pharmaceutical products. The detail are as under:
1117. Name and address of Applicant M/s Servier Research and Pharmaceuticals (Pakistan) Pvt. Ltd., 65
Main Boulevard Gulberg, Lahore
Detail of Drug Sale License Address: M/s Servier Research Pharmaceuticals, Kot abdul malik
ferozwala District Sheikhupura
Status: License to Sell Drugs As a Distributor
License no. 0011000 0002078 valid up to 28-06-2020
Name and address of manufacturer M/s Les Laboratoires Servier Industrie, 905, route de saran 45520
Gidy France
Name and address of marketing M/s Les Laboratoires Servier Industrie, 50, rue carnot-92284
authorization holder suresnes Cedex France
Name of exporting country France
Brand Name +Dosage Form + Strength CARIVALAN 6.25mg/5mg film coated tablets
Carvedilol…….6.25mg
Ivabradine…….5mg
Pharmacological Group Betablocker/ hyperpolarization-activated cyclic nucleotide-gated
channel blocker
Demanded Price
Pack size 14, 28 & 56 Tablets
International availability France
Me-too status N/A
Stability studies Firm has submitted long term Provided data 18 months at
300C±65%RH and 6 months at 400C±75%RH for three batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 026355) issued on 22-03-
2019 by Chamber de commerce et d‘Industrie de Region Paris Ile-

de-Farance declaring the free sale of applied product and GMP
compliant status of the manufacturer i.e., M/s Les Laboratoires
Servier Industrie, 905, route de saran 45520 Gidy France.
 Original Notarized ―Letter of Authorization‖ from M/s Les
Laboratoires Servier Industrie, 50, rue carnot-92284 suresnes
Cedex France declaring M/s Servier Research and
Pharmaceuticals (Pakistan) Pvt. Ltd., Pakistan as marketing
authorization holder in aterritory defined as Pakistan.
Decision: Approved as per policy of inspection of manufacturer abroad
Status: License to Sell Drugs as a Distributor
Gidy France
Brand Name +Dosage Form + Strength CARIVALAN 6.25mg/7.5mg film coated tablets
Ivabradine…….7.5mg
channel blocker
Demanded Price
Me-too status N/A
300C±65%RH (two batches) and one batch 9month and 6 months
at 400C±75%RH for three batches.
Gidy France
Brand Name +Dosage Form + Strength CARIVALAN 12.5mg/7.5mg film coated tablets
channel blocker
Demanded Price
Me-too status N/A
Gidy France
Brand Name +Dosage Form + Strength CARIVALAN 25mg/5mg film coated tablets
Carvedilol…….25mg
Ivabradine…….5mg

channel blocker
Demanded Price
Me-too status N/A
Gidy France
Brand Name +Dosage Form + Strength CARIVALAN 25mg/7.5mg film coated tablets
Carvedilol…….25mg
channel blocker
Demanded Price
Me-too status N/A
1122. Name and address of Applicant M/s Punjab Medical Services Office No. 4/5 2. Floor Jalal Center
Opp. OPC Gme Gangaram Hospital Mozang Road Lahore
Detail of Drug Sale License Address: Punjab Medical Services Office No. 4/5 Jalal Center
Opp. DPO Gate sir Ganga ram Hospital Mozang Road Lahore
License no: 05-352-0063-041061D valid upto 27th Feb. 2021
Name and address of manufacturer M/s Onko Ilac Sanayi ve Ticaret A.S Address: Gebze Organize
Sanayi Bolgesi, 1700 Sokak no: 1703 Gebze Kocaeli Turkey
Name and address of marketing M/s Kocsel Ilac Sanayi ve Tic A.S. Kosuyolu Cad No: 34, 34781
authorization holder Kosuyolu Kadikoy, Istanbul, Turkiye
Brand Name +Dosage Form + Strength Gadotu 287mg/ml IV solution for Injection (10ml)

Gadodiamide….287mg
Finished Product Specification Ph. Eur.

Pharmacological Group MRI contrast agent
Shelf life 24 months: Store at room temperature below 250C
Pack size 10ml glass vial
International availability OMNISCANTM (gadodiamide) Injection for Intravenous by M/s
GE Healthcare Ireland Limited, Cork, Ireland
Me-too status OMNISCAN INJECTION (GADODIAMIDE 287MG/ML) Reg.
23181)
Stability studies Firm has submitted long term (24 months) at 30±2 oC RH 65%+
5%+ 5% & accelerated (06 months) stability data at 40+ 2oC, 75+
5% RH for three batches.
Detail of certificates attached  Original Legalized CoPP (Certificate#. 2018/1148) issued on
22-03-2018 by Republic of Turkey Ministry of Health Turkish
Medicines and Medical Devices Agency declaring the free
sale of applied product and GMP compliant status of the
manufacturer i.e., M/s Onko Ilac Sanayi ve Ticaret A.S
Address: Gebze Organize Sanayi Bolgesi, 1700 Sokak no:
1703 Gebze Kocaeli Turkey valid until 20/03/2020..
 Original Notarized ―Letter of Authorization‖ from M/s Kocsel
Ilac Sanayi ve Tic A.S. Kosuyolu Cad No: 34, 34781
Kosuyolu Kadikoy, Istanbul, Turkiye declaring M/s Punjab
Medical Services, Pakistan authorize to perform registration
procedures, sales and other similar activities concerning
medicinal products for territory defined as Pakistan.
Authorization valid for three years.
1123. Name and address of Applicant M/s Punjab Medical Services Office No. 4/5 2. Floor Ja/a/Center
Brand Name +Dosage Form + Strength Gadotu 287mg/ml IV solution for Injection (20ml)

Gadodiamide….287mg

Pharmacological Group MRI contrast agent
Shelf life 24 months: Store at room temperature below 250C
International availability OMNISCANTM (gadodiamide) Injection for Intravenous by M/s
GE Healthcare Ireland Limited, Cork, Ireland
Me-too status OMNISCAN INJECTION (GADODIAMIDE 287MG/ML) Reg.
23181)
Detail of certificates attached  Original Legalized CoPP (Certificate#. 2018/1148) issued
on 22-03-2018 by Republic of Turkey Ministry of Health
Turkish Medicines and Medical Devices Agency declaring the
free sale of applied product and GMP compliant status of the
1703 Gebze Kocaeli Turkey valid until 20/03/2020.
Kocsel Ilac Sanayi ve Tic A.S. Kosuyolu Cad No: 34, 34781
Authorization valid for three years.
Brand Name +Dosage Form + Strength Kopaq 300 I mg/ml IV solution for Injection (50ml)

Iohexol….647mg

Pharmacological Group X-ray contrast media
Shelf life 36 months: Store below 300C
Pack size 50ml HP 756/100 Pen class of glass
International availability OMNIPAQUE Injection by M/s GE Healthcare Australia
Me-too status OMNIPAQUE INJECTION 300MG/ML of M/s APEX (Reg.
8867)
Authorization valid for three years


Iohexol….647mg


Pack size 100ml HP 756/100 Pen class of glass
Me-too status Iobrix-350 Injection of M/s HOFFMANN (Reg. 32138)
1703 Gebze Kocaeli Turkey valid until 20/03/2020..


Iohexol….755mg

Pack size 50ml sterile type I neutral glass vial
Me-too status OMNIPAQUE INJECTION 350MG/ML of M/s APEX (Reg.
8868)


Iohexol….755mg
Pack size 100ml sterile type I neutral glass vial
Me-too status Iobrix-350 Injection of HOFFMANN (Reg. 32138)

Brand Name +Dosage Form + Strength Ravistu 300mg I/ml solution for Injection (50ml)

Iopromide….623.4mg
International availability Ultravist 300 (MHRA)
Me-too status

Me-too status Ultravist ® 300 (Reg. 072542) of M/s. Medipharm.


Me-too status ULTRAVIST 370 (Reg. 9865) of ALI GOHAR & CO
Stability studies Firm has submitted long term (24 months) at 30±2oC RH 65%+

Me-too status
Stability studies Firm has submitted long term (24 months) at 30±2oC RH 65%+
b. Deferred Cases:
Following products of M/s Servier Research and Pharmaceuticals Pakistan Lahore deferred in
274th meeting of Registration Board. The detail are as under:
1132. Name
1 and address of Applicant M/s Servier Research and Pharmaceuticals Pakistan Private
. limited 65 Main Boulevard Gulberg, Lahore.
Detail of Drug Sale License Address: Servier Research and Pharmaceuticals Pakistan Private
limited, 9km Lahore Sheikhupura road, near Dosaco chowk Kot
Abdul Malik, Tehsil Ferozewala, District Sheikhupura
Status: License to sell drugs in Pharmacy
Name and address of manufacturer M/s. Les Laboratoirie Industrie, 905, route de Saran 45520
Gidy, France.
Name and address of Product License M/s Les Laboratories Servier -50 rue Carnot -92282 Suresnes
Holder Cedex-France
Exporting Country France
Brand Name +Dosage Form + Triveram 20mg/10mg/10mg
Strength Film coated tablets
Composition Each film coated tablets contains:-
Atorvastatin calcium trihydrate………………21.64mg
(Eq. to Atorvastatin…….20mg)
Perindopril Arginine……………………….…10mg
(Eq. to Perindopril……..6.79mg)
Amlodipine beilate…………..………………..13.87mg
(Eq. to amlodipine……..10mg)
Pharmacological Group (Statin/ACE Inhibitors/Calcium Antagonist)
Shelf life 2 years
Pack size 30 tablets in HDPE bottle with dessicant
Demanded Price Not Proposed
Intrnational availability Available in France as per CoPP
Me-too status N/A
Detail of certificates Not provided
Remarks of the Evaluator. Following documents are not provided;
1. Original legalized CoPP
2. Stability data for zone IV-A
3. Approval status in reference regulatory authorities
Orevious Decision:
In 260th meeting Registration Board deferred the case for submission of original & legalized CoPP,
approval status in reference authorities and stability data as per zone IV-A
Evaluation by PEC:
The firm has submitted following documents:

1. Original & legalized CoPP (certificate No. 013199) issued by Commerce and Industry Chamber of
Paris Ile de France region on 11/07/2017 describes that the facilities and operations conform to GMP as
recommended by WHO.
2. The product is not available in exporting country for free sale, the reasons statedin CoPp are as follows;
 The medicinal product has been reformulated in order to improve its stability under tropical
conditions.
 The medicinal product has been exclusively developed for the treatment of diseases, especially
for tropical diseases, which are not endemic in the exporting country.
 The medicinal product has been reformulated to exclude excipients which are not approved in the
importing country.
 The medicinal product has been reformulated to comply with a requirement regarding the dosage
of an active ingredient
 The medicinal product has a marketing authorization for another dose, another pharmaceutical
form or a different formulation.
However, the firm has quoted the decision of Registration Board:
"if an imported drug is not on free sale in its respective country of origin /manufacture, such product will
be registered in Pakistan if the product manufactured in the applied facility is approved by any of the
regulatory authorities from USFDA, EMA, PMDA Japan, Australia TGA, Health Canada, Switzerland or
any of regulatory authority of former erstwhile Westren Europe (United Kingdom, Germany, France,
Switzerland, Netherlands, Austria, Belgium, Denmark, Finland, Sweden, Italy, Ireland, Luxemburg,
Norway, Scotland and Spain) or three stringent regulatory bodies of former erstwhile Eastren Europe.
However, references countries regarding availability of drug / molecule /formulation shall remain the
same as specified in 249th meeting of RegistrationBoard‟‟.
The firm has provided following reference where the product is registered, which have been verified.
 Ireland (Triveram 20mg/10mg/10mg film-coated tablets)
https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA0568-028-004_24042017124231.pdf
 Estonia (Triveram 20mg/10mg/10mg film-coated tablets)
http://ravimiregister.ravimiamet.ee/en/default.aspx?pv=HumRavimid.Otsing
 Poland (Triveram 20mg/10mg/10mg film-coated tablets)
http://pub.rejestrymedyczne.csioz.gov.pl/(X(1)S(agwz3bqzsblyxdimdge4wuyd))/Rejestr.aspx?AspxAuto
DetectCookieSupport=1#results
2. Stability data of 3 batches
Deferred for submission of CoPP‟s of the countries where the product is registered for confirmation of
free sale of the product.
Now the firm has submitted Original Legalized CoPP (Certificate#. 026370) issued on 22-03-2019 by
Chamber de commerce et d‘Industrie de Region Paris Ile-de-Farance declaring the free sale of applied
product and GMP compliant status of the manufacturer i.e., M/s Les Laboratoires Servier Industrie, 905,
route de saran 45520 Gidy France.
Decision : Approved as per policy of inspection of manufacturer abroad

1133. Name
2 and address of Applicant M/s Servier Research and Pharmaceuticals Pakistan Private
. limited 65 Main Boulevard Gulberg, Lahore.
Detail of Drug Sale License Address: Servier Research and Pharmaceuticals Pakistan Private
limited, 9km Lahore Sheikhupura road, near Dosaco chowk Kot
Abdul Malik, Tehsil Ferozewala, District Sheikhupura
Status: License to sell drugs in Pharmacy
Name and address of manufacturer M/s. Les Laboratoirie Industrie, 905, route de Saran 45520
Gidy, France.
Name and address of Product License M/s Les Laboratories Servier -50 rue Carnot -92282 Suresnes
Holder Cedex-France
Exporting Country France

Brand Name+Dosage Form + Strength Triveram 10mg/5mg/5mg
Film coated tablets
Composition Each film coated tablets contains:-
Atorvastatin calcium trihydrate………………10.82mg
(Eq. to Atorvastatin…….10mg)
Perindopril Arginine……………………….…5mg
(Eq. to Perindopril……..3.40mg)
Amlodipine beilate…………..………………..6.94mg
(Eq. to amlodipine……..5mg)
Pharmacological Group (Statin/ACE Inhibitors/Calcium Antagonist)
Shelf life 2 years
Pack size 30 tablets in HDPE bottle with dessicant
Demanded Price Not Proposed
Intrnational availability Available in France as per CoPP
Me-too status N/A
Detail of certificates Not provided
Remarks of the Evaluator. Following documents are not provided;
1. Original legalized CoPP
2. Stability data for zone IV-A
3. Approval status in reference regulatory authorities
Orevious Decision:
In 260th meeting Registration Board deferred the case for submission of original & legalized CoPP,
approval status in reference authorities and stability data as per zone IV-A
Evaluation by PEC:
The firm has submitted following documents:
1. Original & legalized CoPP (certificate No. 013198) issued by Commerce and Industry Chamber of
Paris Ile de France region on 11/07/2017 describes that the facilities and operations conform to GMP as
recommended by WHO.
2. The product is not available in exporting country for free sale, the reasons statedin CoP p are as follows;
 The medicinal product has been reformulated in order to improve its stability under tropical
conditions.
 The medicinal product has been exclusively developed for the treatment of diseases, especially for
tropical diseases, which are not endemic in the exporting country.
 The medicinal product has been reformulated to exclude excipients which are not approved in the
importing country.
 The medicinal product has been reformulated to comply with a requirement regarding the dosage of an
active ingredient
 The medicinal product has a marketing authorization for another dose, another pharmaceutical form
or a different formulation.
However, the firm has quoted the decision of Registration Board:
"if an imported drug is not on free sale in its respective country of origin /manufacture, such product will
be registered in Pakistan if the product manufactured in the applied facility is approved by any of the
regulatory authorities from USFDA, EMA, PMDA Japan, Australia TGA, Health Canada, Switzerland or
any of regulatory authority of former erstwhile Westren Europe (United Kingdom, Germany, France,
Switzerland, Netherlands, Austria, Belgium, Denmark, Finland, Sweden, Italy, Ireland, Luxemburg,
Norway, Scotland and Spain) or three stringent regulatory bodies of former erstwhile Eastren Europe.
However, references countries regarding availability of drug / molecule /formulation shall remain the
same as specified in 249th meeting of RegistrationBoard‟‟.
The firm has provided following reference where the product is registered, which have been verified.
 Ireland (Triveram 10mg/5mg/5mg film-coated tablets)
https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA0568-028-001_24042017124311.pdf
 Estonia (Triveram 10mg/5mg/5mg film-coated tablets)
http://ravimiregister.ravimiamet.ee/en/default.aspx?pv=HumRavimid.Otsing
 Poland (Triveram 10mg/5mg/5mg film-coated Tablets)
http://pub.rejestrymedyczne.csioz.gov.pl/(X(1)S(agwz3bqzsblyxdimdge4wuyd))/Rejestr.aspx?AspxAuto
DetectCookieSupport=1#results
Stability data of 3 batches.
Deferred for submission of CoPP‟s of the countries where the product is registered for confirmation of
free sale of the product
Now the firm has submitted Original Legalized CoPP (Certificate#. 026369) issued on 22-03-2019 by
Chamber de commerce et d‘Industrie de Region Paris Ile-de-Farance declaring the free sale of applied
product and GMP compliant status of the manufacturer i.e., M/s Les Laboratoires Servier Industrie, 905,
route de saran 45520 Gidy France.
Decision: Approved as per policy of inspection of manufacturer abroad.
Evaluator PEC-XI
Case No. 01: Registration applications for local manufacturing of (Human) Drugs.
a. New cases
1134. Name and address of manufacturer / Sigma Pharma International (Pvt) Ltd., Plot # E-50, North
Applicant Western Industrial Zone, Bin Qasim, Karachi, Pakistan
Brand Name +Dosage Form + Strength Torsom Tablet 250mg
Levetiracetam…….250mg
Pharmacological Group Other antiepileptics
Type of Form Form 5
Approval status of product in Levetiracetam 250 mg film-coated tablets. MHRA approved
Me-too status Leveticam film-coated 250mg Tablets. Reg. No. 84220
GMP status The firm has been granted GMP certificate on the basis of
inspection dated 18.09.2018.
Remarks of the Evaluator. 
Decision: Approved.
Type of Form Form 5
Decision: Approved.
Levetiracetam……750mg

Type of Form Form 5
Me-too status Levotam film-coated 750mg Tablets. Reg. No. 55641
Decision: Approved.
Brand Name +Dosage Form + Strength Torsom XR Tablet 500mg
Composition Each extended release tablet contains:
Levetiracetam……500mg
Type of Form Form 5
Approval status of product in KEPPRA XR (levetiracetam) film-coated extended-release
Reference Regulatory Authorities. tablets, for oral use. MHRA approved
Me-too status Lerace XR Tablet. Reg. No. 70417
Decision: Approved.
Brand Name +Dosage Form + Strength Nofovir Tablet 300mg
Tenofovir disproxil fumarate………..300mg
Type of Form Form 5
Finished Product Specification IP
Approval status of product in Viread 300mg Tablets. US-FDA approved
Me-too status Xenofovir Tablet. Reg. No. 81653
Decision: Approved.
Brand Name +Dosage Form + Strength Thickside Capsule 4mg
Thiocolchicoside…….4mg
Type of Form Form 5
Approval status of product in MIOREL 4 mg capsule. ANSM approved
Me-too status Muscucoside capsule 4mg. Reg. No. 81656
Brand Name +Dosage Form + Strength Artist Tablet 80mg
Telmisartan…….80mg
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain
Type of Form Form 5
Approval status of product in Telmark 80mg film-coated tablets. MHRA approved
Me-too status Tesart 80mg film-coated Tablets. Reg. No. 45083
Remarks of the Evaluator. .
Decision: Approved.
Type of Form Form 5
Me-too status Tesart 40mg film-coated Tablets. Reg. No. 45082
Decision: Approved.
Type of Form Form 5
Me-too status Pressurex 20mg film-coated Tablets. Reg. No. 67535
Decision: Approved.
Brand Name +Dosage Form + Strength Masaco Tablet 800mg
Mesalazine…….800mg
Pharmacological Group Aminosalicylic acid and similar agents
Type of Form Form 5
Approval status of product in ASACOL® HD (mesalamine) delayed-release tablets, for oral
Reference Regulatory Authorities. use. MHRA approved
Me-too status Masacol 800mg Tablet. Reg. No. 61348
Remarks of the Evaluator.  The firm has mentioned film-coated tablet with seal coat and
modified release coat. Upon clarification, the firm revised
the coating to enteric coating without fee. However, the
reference product has an outer protective coat consisting of a
combination of acrylic based resins, Eudragit S (methacrylic
acid and methyl methacrylate copolymer (1:2), NF) and
Eudragit L (methacrylic acid and methyl methacrylate
copolymer (1:1), NF). The inner coat consists of an acrylic
based resin, Eudragit S, which dissolves at pH 7 or greater,
releasing mesalamine in the terminal ileum and beyond for
topical anti- inflammatory action in the colon.
Decision: Deferred for clarification from the firm.
Brand Name +Dosage Form + Strength Mesaco Tablet 400mg
Composition Each modified release tablet contains:
Mesalazine…….400mg
Pharmacological Group Aminosalicylic acid and similar agents
Type of Form Form 5
Approval status of product in ASACOL® HD (mesalamine) delayed-release tablets, for oral
Reference Regulatory Authorities. use. MHRA approved
Me-too status Coltab Tablet 400mg. Reg. No. 41652
Remarks of the Evaluator.  The firm has mentioned film-coated tablet with seal coat and
modified release coat. Upon clarification, the firm revised
the coating to enteric coating without fee. However, the
reference product has an outer protective coat consisting of a
combination of acrylic based resins, Eudragit S (methacrylic
acid and methyl methacrylate copolymer (1:2), NF) and
Eudragit L (methacrylic acid and methyl methacrylate
copolymer (1:1), NF). The inner coat consists of an acrylic
based resin, Eudragit S, which dissolves at pH 7 or greater,
releasing mesalamine in the terminal ileum and beyond for
topical anti- inflammatory action in the colon.
Decision: Deferred for clarification from the firm.
Brand Name +Dosage Form + Strength Vibes Tablet 7.5mg
Ivabradine as HCl…….7.5mg
Pharmacological Group Other cardiac preparations
Type of Form Form 5
Approval status of product in CORLANOR film-coated tablets, for oral use. USFDA

Me-too status Ivatab 7.5mg Tablet. Reg. No. 76155
Brand Name +Dosage Form + Strength Vibes Tablet 5mg
Ivabradine as HCl…….5mg
Type of Form Form 5

Approval status of product in CORLANOR film-coated tablets, for oral use. USFDA
Me-too status Ivatab 5mg Tablet. Reg. No. 76154
Brand Name +Dosage Form + Strength Change Tablet 5mg
Escitalopram as oxalate…….5mg
Type of Form Form 5
Approval status of product in Lexapro® (escitalopram) 5mg film-coated Tablets, for oral use.
Reference Regulatory Authorities. USFDA approved
Me-too status Dipgo Tablet 5mg, film-coated. Reg. No. 85714
Decision: Approved
Brand Name +Dosage Form + Strength Merriot Tablet 30mg
Mirtazapine…….30mg
Pharmacological Group Other antidepressants
Type of Form Form 5
Approval status of product in Remeron film-coated 30mg tablet. USFDA approved
Me-too status Remirta 30mg Tablet. Reg. No. 82606
Decision: Approved.
Brand Name +Dosage Form + Strength Merriot Tablet 15mg
Mirtazapine…….15mg
Type of Form Form 5
Approval status of product in Remeron film-coated 15mg tablet. USFDA approved
Me-too status Remirta 15mg Tablet. Reg. No. 82605
Decision: Approved.
Brand Name +Dosage Form + Strength Urdoo Capsule 250mg
Ursodeoxycholic acid…….250mg
Pharmacological Group Bile acids and derivatives
Type of Form Form 5
Approval status of product in URSOFALK ursodeoxycholic acid 250mg capsule blister pack.
Reference Regulatory Authorities. TGA approved
Me-too status Rivsa 250mg Capsule. Reg. No. 82263
Decision: Approved.
Brand Name +Dosage Form + Strength Urdoo Capsule 500mg
Type of Form Form 5
Approval status of product in Ursochol 500 mg capsule, hard. Swedish Medical Product
Reference Regulatory Authorities. Agency approved
Decision: Approved.
Brand Name +Dosage Form + Strength Bosten Tablet 62.5mg
Bosentan as monohydrate…….62.5mg
Type of Form Form 5
Approval status of product in TRACLEER® (bosentan) film-coated tablets, for oral use.
th
Me-too status Bsantan 62.5mg film-coated tablets. Reg. No. 84199
Brand Name +Dosage Form + Strength Wemet Tablet 50/500mg
Sitagliptin as phosphate monohydrate…….50mg
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form 5
Approval status of product in JANUMET® (sitagliptin and metformin HCl) tablet, 50/500mg
Reference Regulatory Authorities. film-coated. USFDA approved
Me-too status Neoglip 50/500mg Tablets. Reg. No. 53099
Brand Name +Dosage Form + Strength Wemet Tablet 50/1000mg
Type of Form Form 5
Approval status of product in JANUMET® (sitagliptin and metformin HCl) tablet,
Reference Regulatory Authorities. 50/1000mg film-coated. USFDA approved
Brand Name +Dosage Form + Strength Cornil Tablet 10mg
Nicorandil………10mg
Diary No. Date of R& I & fee Dy No. 6955: 23.02.2018
PKR 20,000/-: 23.02.2018
Pharmacological Group Other vasodilators used in cardiac diseases
Type of Form Form 5
Approval status of product in IKOREL Nicorandil 10mg un-coated tablet. TGA approved
Me-too status Nicodil 10mg Tablet. Reg. No. 83345
Decision: Approved.
Brand Name +Dosage Form + Strength Cornil Tablet 20mg
Nicorandil………20mg
Type of Form Form 5
Approval status of product in IKOREL Nicorandil 20mg un-coated tablet. TGA approved
Me-too status Nicodil 20mg Tablet. Reg. No. 83346
Decision: Approved.
1157. Name and address of manufacturer / High-Q Pharmaceuticals Plot No. 224, Sector 23 Korangi
Brand Name +Dosage Form + Strength Pramadol Tablet
Tramadol HCl……37.5mg
Paracetamol……..325mg
Pharmacological Group Opioids in combination with non-opioid analgesics
Type of Form Form 5
Pack size & Demanded Price 10‘s; As per leader price
Approval status of product in ULTRACET (tramadol hydrochloride and acetaminophen)
Reference Regulatory Authorities. tablets, for oral use by Janssen Pharms US-FDA approved
Me-too status Tril-P Tablet by Linta Pharmaceuticals. Reg. No. 78181
GMP status The firm was inspected on 10.04.2018 with the Conclusion:
―Based on the areas inspected, the people met and the
documents reviewed, and considering the finding of inspection,
including the observations & advises made, M/s High-Q
Pharma is located at plot no.224, sector 23, Karachi was
considered to be operating at an acceptable level of compliance
with good manufacturing practices for Pharma products.‖
Decision: Approved.
1158. Name and address of manufacturer / AGP Limited B-23, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Rivarox 2.5mg tablet
Rivaroxaban……..2.5mg
Pharmacological Group Factor Xa inhibitor
Type of Form Form 5
Finished Product Specification The firm has claimed innovator‘s specifications
Pack size & Demanded Price 14‘s; Rs. 3796.77/-
28‘s; Rs. 7213.54/-
Approval status of product in Rivaroxaban 2.5mg film-coated tablets. USFDA approved
Me-too status XARELTO 2.5MG TABLETS. Reg No. 74794
GMP status GMP granted on the basis of inspection dated 16.10.2018
Decision: Approved.
1159. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt) Ltd. Plot No. E-145 to E-
Applicant 149, North western Industrials Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Spacinol Tablet 80/80mg
Composition Each sugar-coated tablet contains:
Phloroglucinol hydrate…..80mg
trimethylphloroglucinol ……..80mg
Pharmacological Group Drugs for functional gastrointestinal disorders
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer specifications.
Approval status of product in Phloroglucinol/Trimethylphloroglucinol Acino 62.233mg/
Reference Regulatory Authorities. 80mg, coated tablet by ACINO France SAS. Approved by
ANSM
Me-too status Despasm Tablet by Irza Pharmaceuticals. Reg. No. 85210
GMP status The firm was last inspected on 07.09.2017, wherein the firm
was rated at satisfactory level of cGMP compliance.
1160. Name and address of manufacturer / M/s Genix Pharma (Pvt) Ltd 44, 45-B Korangi Creek Road,
Applicant Karachi 75190, Pakistan
Brand Name +Dosage Form + Strength Lotenol (0.5% w/v) Ophthalmic Suspension
Composition Each ml of suspension contains:
Loteprednol etabonate…..5mg
Pharmacological Group Corticosteroids, plain
Type of Form Form 5
Finished Product Specification The firm has claimed innovator‘s specifications.
Pack size & Demanded Price 2.5ml, 5ml, 10ml; As per PRC
Approval status of product in Lotemax ophthalmic suspension 0.5% (w/v). USFDA approved
Me-too status Lotepred Forte Ophthalmic Suspension 0.5%. Reg. # 67458
GMP status The firm was inspected on 16.02.2018, with the following
conclusion:
"In the light of inspected areas, facilities status of equipment
complaints handling & other cGMP issues, M/s Genix Pharma
Pvt. Ltd Karachi was considered at an satisfactory level of
compliance with cGMP guidelines as of today. The
management was also suggested to further strengthen stability
and analytical sections.‖
Decision: Approved.
1161. Name and address of manufacturer / M/s Genix Pharma (Pvt) Ltd 44, 45-B Korangi Creek Road,
Applicant Karachi 75190, Pakistan
Brand Name +Dosage Form + Strength Denide (0.05% w/w) Cream
Desonide…..0.5mg
Pharmacological Group Corticosteroids, moderately potent (group II)
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 60g; As per PRC

Approval status of product in DESOWEN Desonide 0.5mg/g cream tube. TGA approved
Me-too status Stienoide Cream. Reg. # 46986
conclusion:
"In the light of inspected areas, facilities status of equipment
complaints handling & other cGMP issues, M/s Genix Pharma
Pvt. Ltd Karachi was considered at an satisfactory level of
compliance with cGMP guidelines as of today. The
management was also suggested to further strengthen stability
and analytical sections.‖
Decision: Approved.
1162. Name and address of manufacturer / M/s Akhai Pharmaceuticals (Pvt.) Ltd. Plot # A-248 & A-256
Applicant to A-259, HITE, Lasbela Balochistan, Pakistan
Brand Name +Dosage Form + Strength Ezibe 10mg Tablet
Ezetimibe……..10mg
Pharmacological Group Other lipid modifying agents
Type of Form Form 5
Pack size & Demanded Price 1x10‘s; as per SRO
Approval status of product in ZETIA (ezetimibe) Tablets. USFDA approved
Me-too status Ezemibe Tablets 10mg. Reg No. 35815
GMP status The firm was inspected on 15.03.2018, wherein GMP was
rated as GOOD.
Decision: Approved.
1163. Name and address of manufacturer / Next Pharmaceutical Products Private Limited Plot No 44 A-B,
Applicant Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Fexo Plus Tablet 60/120mg
Composition Each extend release tablet contains:
Fexofenadine HCl…..60mg
Pseudoephedrine HCl……120mg
PKR 5,000/-: 01.01.2019
Pharmacological Group pseudoephedrine, combinations
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s; As per decision of PRC
Approval status of product in ALLEGRA-D 12 HOUR Extended-Release Tablets. USFDA
Me-too status Fexet-D 60Mg/120Mg film-coated Tablets. Reg No. 39099
(data does not depict two layer tablet)
GMP status The firm was last inspected on 22.02.2018, wherein the panel
stated the firm had four sections but only two sections (Tablet
and capsules) are operational at the time of inspection, and
rated the GMP compliance as satisfactory.
Remarks of the Evaluator.  The reference product is in the form of two layer extended
release tablet. The firm revised formulation accordingly,

along with submission of Rs. 5,000/-.
 The firm was asked to provide proof of availability of
manufacturing facility. The firm requested for withdrawal of
the product due to non-availability of bilayer tablet machine.
Decision: Registration Board acceded to request for withdrawl of application and it stands
disposed off.
1164. Name and address of manufacturer / M/s Barrett Hodgson Pakistan (Private) Ltd. F/423, SITE,
Applicant Karachi
Brand Name +Dosage Form + Strength Xyloaid 2% Injection with epinephrine (adrenaline) 1:200,000
(ampule)
Lidocaine HCl (as monohydrate)……..20mg
Epinephrine as bitartrate……5mcg
Pharmacological Group lidocaine, combinations
Type of Form Form 5
Pack size & Demanded Price 10ml x50‘s; Rs.1277.47
Approval status of product in XYLOCAINE® PARENTERAL SOLUTIONS (20mL vial,
Reference Regulatory Authorities. 10ml plastic ampule). Health Canada approved. However, it is
not confirmed whether it is lidocaine HCl, lidocaine HCl
monohydrate or lidocaine HCl as monohydrate.
Me-too status Lovocain 2% Injection. Reg. No. 48306 (5ml).
GMP status The firm was inspected on 16th-28th August, 2018
Conclusion:
The firm has complied and addressed all the observations as
progressive towards good level of GMP compliance.
Remarks of the Evaluator.  The me-too products contain epinephrine (with 5ml fill
volume); however, the firm has applied for Epinephrine as
bitartrate.
 Proof of me-too product approved by DRAP with same fill volume and same salt form.
 Proof of International availability of same dosage form with same strength in reference
regulatory authority as defined in 275th meeting of the Registration Board is required.
Applicant Karachi
Brand Name +Dosage Form + Strength Xyloaid 2% Injection
Pharmacological Group Local anesthetics
Type of Form Form 5
Pack size & Demanded Price 10ml x50‘s; Rs.1258.41
Approval status of product in Lidocaine 20 mg/ml solution for injection. MHRA approved
Me-too status GEE-Ligno Injection. Reg. No. 80834 (10ml)
GMP status The firm was inspected on 16th-28th August, 2018
Conclusion:
The firm has complied and addressed all the observations as
progressive towards good level of GMP compliance.
Decision: Deferred as firm has already same formulation

Applicant Karachi
Brand Name +Dosage Form + Strength Xyloaid 2% Jelly for topical use
Lidocaine HCl as monohydrate……..20mg
Pharmacological Group Anesthetics for topical use
Type of Form Form 5
Pack size & Demanded Price 15gm; Rs.42.50
Approval status of product in Xylocain® 2% gel. Approved in Norway
Me-too status Logel 2w/w. Reg. No. 40221
Applicant Karachi
Brand Name +Dosage Form + Strength Xyloaid 4% Topical solution
Type of Form Form 5
Pack size & Demanded Price 50ml; Rs.63.14
Approval status of product in XYLOCAINE 4% TOPICAL liqnocaine hydrochloride
Reference Regulatory Authorities. 40mg/mL solution bottle. TGA approved
Me-too status XYLOCAINE 4% TROPICAL SOL. Reg. No. 380
Applicant Karachi
Brand Name +Dosage Form + Strength Xyloaid 5% Ointment
Lidocaine ……..50mg
Type of Form Form 5
Pack size & Demanded Price 20g; Rs.61.42
Approval status of product in Lidocaine 5% m/m Ointment. MHRA approved
Me-too status Xylocaine 5% Ointment. Reg. No. 23075
1169. Name and address of manufacturer / M/s Fozan Pharmaceutical. 36-A, Industrial Estate, Hayatabad,
Applicant Peshawar
Brand Name +Dosage Form + Strength Mecofoz Tablet
Composition Each sugar-coated tablet contains:
Mecobalamin ……….500µg
PKR 5,000/-: 14.03.2019
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of Form Form 5
Pack size & Demanded Price 3x10‘s, 10x10‘s; As per DRAP policy
Approval status of product in Methicobide tablet 500 mcg sugar-coated, by Daito
Reference Regulatory Authorities. Corporation. Approved by PMDA Japan
Me-too status Balin 500mcg Tablet (sugar-coated) by Cibex Pharma Karachi.
Reg. No. 74877
GMP status The firm was inspected on 25.05.2018, wherein the GMP was
reported satisfactory.
Remarks of the Evaluator.  The firm revised the formulation to sugar-coated tablet along
with submission of Rs. 5000/- fee.
Decision: Approved
1170. Name and address of manufacturer / Linta Pharmaceuticals (Pvt.) Limited, Plot No. 03, Street No. S-
Applicant 5, National Industrial Zone Rawat, Islamabad-Pakistan
Brand Name +Dosage Form + Strength Levecet Tablet 250mg
Type of Form Form 5
GMP status The firm was inspected on 12.06.2018, wherein the firm was
reported to be GMP compliant.
Type of Form Form 5
Type of Form Form 5
Me-too status Levotam film-coated 750mg Tablets. Reg. No. 55641
Brand Name +Dosage Form + Strength Glita Plus Tablet 50/500mg
Type of Form Form 5
 Decision: Approved with innovator‘s specifications
Brand Name +Dosage Form + Strength Glita Plus Tablet 50/1000mg
Type of Form Form 5
Approval status of product in JANUMET® (sitagliptin and metformin HCl) tablet,
Reference Regulatory Authorities. 50/1000mg film-coated. USFDA approved
Brand Name +Dosage Form + Strength Airmax Tablet 5mg
Composition Each chewable tablet contains:
Montelukast (as sodium)…….5mg
PKR 5,000/-: 20.03.2019
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Approval status of product in SINGULAIR® (montelukast sodium) Chewable Tablets.
Me-too status Nohist Chewable Tablet 5mg. Reg. No. 85712
Remarks of the Evaluator.  The firm revised the formulation to chewable tablets in line
with the reference product along with submission of Rs.
5000/- fee.
Brand Name +Dosage Form + Strength Airmax Tablet 10mg
Montelukast (as sodium)…….10mg
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Approval status of product in Montelukast 10 mg film-coated tablets. MHRA approved
Me-too status Nohist Tablet 10mg. Reg. No. 85713
Brand Name +Dosage Form + Strength Blin Capsule 50mg
Pregabalin…….50mg
Type of Form Form 5
Approval status of product in Alzain 50 mg Capsules, Hard. MHRA approved
Me-too status Scirica 50mg Capsule. Reg. No. 82187
Brand Name +Dosage Form + Strength Flix Capsule 150mg
Fluconazole…….150mg
Pharmacological Group Antimycotics for systemic use
Type of Form Form 5
Approval status of product in Fluconazole 150mg Capsules. MHRA approved
Me-too status Conza Capsule. Reg. No. 84049
Brand Name +Dosage Form + Strength Fude-H Cream
Composition Each gram of cream contains:
Fusidic Acid……20mg
Hydrocortisone……10mg
Pharmacological Group Corticosteroids, combinations with antibiotics
Type of Form Form 5
Approval status of product in Fucidin H Cream by LEO Laboratories Limited. MHRA
Me-too status Hivate Cream by Saffron Pharma. Reg. No. 46432
Brand Name +Dosage Form + Strength Low-B Plus 50/12.5mg Tablet
Losartan potassium……50mg
Hydrochlorothiazide……12.5mg
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics
Type of Form Form 5
Approval status of product in FORTZAAR 50 mg / 12.5 mg film-coated tablets. ANSM
Me-too status Rosar-H Tablets. Reg. No. 64218
1181. Name and address of manufacturer / Fedro Pharmaceuticals (Pvt.) Ltd., 149-Industrial Estate,
Applicant Hayatabad, Peshawar, Khyber Pakhtunkhwa, Pakistan
Brand Name +Dosage Form + Strength Fedsert Tablet 50mg
Sertraline as HCl……50mg
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s; As per DRAP policy
Approval status of product in ZOLOFT (sertraline hydrochloride) 50mg film-coated tablets,
Reference Regulatory Authorities. for oral use. USFDA approved
Me-too status Lowtral 50mg Tablets. Reg. No. 51000
GMP status The firm was inspected 30.01.2019 with the following
conclusion and recommendations:
Conclusion:
The firm has rectified majority of observations noted in the
previous inspection and the management is committed to
further improve their cGMP compliance. The firm may be
considered operating in satisfactory level of cGMP compliance.
Recommendations:
They are advised to:-
1- Further increase no of Pharmacist in production section.
2- Purchase another HPLC for tests and analysis.
3- Provide room for retention samples.
Remarks of the Evaluator.  The firm revised ‗sertraline as HCl‘ to ‗sertraline HCl‘ in
Master formula only.
 Decision: Deferred for fee
Brand Name +Dosage Form + Strength Fedsert Tablet 100mg
Sertraline as HCl……100mg
Type of Form Form 5
Approval status of product in ZOLOFT (sertraline hydrochloride) 100mg film-coated tablets,
Me-too status Lowtral 100mg Tablets. Reg. No. 50993
Remarks of the Evaluator.  The firm revised ‗sertraline as HCl‘ to ‗sertraline HCl‘ in
Master formula only.
 Decision: Deferred for fee
Brand Name +Dosage Form + Strength Lorx Tablet 4mg
Lornoxicam……4mg
Pharmacological Group Oxicams
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, 50‘s; As per DRAP policy
Approval status of product in XEFO 4 mg film-coated tablets. ANSM approved
Me-too status Noxilor Tablet. Reg. No. 84039
Brand Name +Dosage Form + Strength Lorx Tablet 8mg
Lornaxicam……8mg
Pharmacological Group Oxicams
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, 50‘s; As per DRAP policy
Approval status of product in NOXON 8 mg film-coated tablets. AIFA approved
Me-too status Lornoxi DS 8mg Tablet. Reg. No. 74933
th
Type of Form Form 5
Decision: Approved
Type of Form Form 5
Decision: Approved
1187. Name and address of manufacturer / Winthrox Laboratories, (Pvt) Ltd., K-219-A, SITE, Super
Applicant Highway, Phase-II, Karachi, Pakistan
Brand Name +Dosage Form + Strength Winfan-P Tablet 50mg
Diclofenac potassium……50mg
PKR 5,000/-: 08.03.2019
Pharmacological Group Acetic acid derivatives and related substances
Type of Form Form 5
Approval status of product in Diclofenac Potassium 50 mg film-coated Tablets. MHRA
Me-too status Arnil-P 50mg film-coated tablets. Reg # 82129
GMP status The firm was inspected on 14.09.2017, wherein the GMP of the
firm was rated as GOOD.
Remarks of the Evaluator.  The firm revised the formulation to film-coated tablet with
submission of Rs. 5,000/- fee.
Brand Name +Dosage Form + Strength Windic Tablet 50mg
Composition Each enteric-coated tablet contains:
Diclofenac sodium……50mg
PKR 5,000/-: 08.03.2019
Type of Form Form 5
Approval status of product in Diclofenac Sodium 50 mg gastro-resistant tablets. MHRA
Me-too status Diclopal 50mg delayed release tablet. Reg # 82298
Remarks of the Evaluator.  The firm revised the formulation to enteric-coated tablet with
submission of Rs. 5,000/- fee.
Brand Name +Dosage Form + Strength Windic SR Tablet 100mg
Composition Each sustained release tablet contains:
Diclofenac sodium……100mg
PKR 5,000/-: 08.03.2019
Type of Form Form 5
Approval status of product in Dicloflex Retard 100 mg prolonged release tablet. MHRA
Me-too status Diclorax 100mg Tablet. Reg. # 85498
Remarks of the Evaluator.  The firm revised the formulation to sustained release tablet
with submission of Rs. 5,000/- fee.
 The revised coating composition has HPMC 15cp as binder.
The reference product contains sub-coat of Copovidone and
Sucrose, and Pigmented film coat of Opadry 02B24025. The
dossier does not depict the same.
 The firm was asked about the use of sustained release
polymer in composition, i.e., how the drug release was
sustained/extended. The firm did not justify the same. The
firm has mentioned HMPC K100 and HPMC K4 as binder.
 Decision: Deferred for further clarification from the firm.
1190. Name and address of manufacturer / Weather Folds Pharmaceuticals Plot No. 12 Street # N-3
Applicant National Industrial Zone (RCCI) Rawat Islamabad Pakistan
Brand Name +Dosage Form + Strength Telmi Tablet 40mg
Telmisartan………40mg
Type of Form Form 5
Approval status of product in Reference Mirpresoc 40mg tablets. MHRA approved
Me-too status Mycardix 40mg Tablets. Reg. No. 44216
GMP status The firm was inspected on 15.09.2017 with the following
conclusion:
Overall the firm was GMP Compliant as per DRAP Guidelines.
Brand Name +Dosage Form + Strength Telmi AM Tablet 40/5mg
Amlodipine as Besylate…..5mg
Telmisartan………40mg
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain +
Dihydropyridine derivatives
Type of Form Form 5
Pack size & Demanded Price 2x7; As per SRO
Approval status of product in Reference TWYNSTA® (telmisartan/amlodipine) 40/5mg tablets, for oral
Regulatory Authorities. use. USFDA approved
Me-too status Amtas 5mg + 40mg Tablet. Reg. No. 66943
conclusion:
Overall the firm was GMP Compliant as per DRAP Guidelines.
Brand Name +Dosage Form + Strength Vastafo 10mg
Rosuvastatin as calcium…..10mg
PKR 20,000/-: 08.01.2018
Pharmacological Group HMG CoA reductase inhibitors
Type of Form Form 5
Approval status of product in Reference Crestor 10mg film-coated tablets. MHRA approved
Me-too status Rostat 10mg Tablet. Reg. No. 55730
1193. Name and address of manufacturer / Cunningham Pharmaceuticals (Pvt.) Ltd., Plot # 81, Sunder
Applicant Industrial Estate, Raiwand Road Lahore
Brand Name +Dosage Form + Strength Amodip Tablet 10/160mg
Amlodipine (as besylate) …….10mg
Valsartan……….160mg
Pharmacological Group Antihypertensives
Type of Form Form 5
Pack size & Demanded Price 14‘s, 28‘s; As per SRO
Approval status of product in Exforge film-coated tablet 10/160. USFDA approved
Me-too status VALTAN -M 170 PLUS TABLET. Reg. No. 77207
GMP status GMP Certificate issued on the basis of inspection
dated 01.04.2019
Type of Form Form 5
Approval status of product in Exforge film-coated tablet 5/160. USFDA approved
GMP status GMP Certificate issued on the basis of inspection
dated 01.04.2019
Type of Form Form 5
Approval status of product in Exforge film-coated tablet 5/80. TGA approved
GMP status GMP Certificate issued on the basis of inspection dated
01.04.2019

Brand Name +Dosage Form + Strength Revo Tablet 25mg
Eltrombopag as olamine…….25mg
Pharmacological Group Other systemic hemostatics
Type of Form Form 5
Approval status of product in PROMACTA® (eltrombopag asolamine) 25 mg film-coated
Reference Regulatory Authorities. tablets, for oral use. USFDA approved
Me-too status REVOLADE TABLETS 25MG. Reg. No. 69584
01.04.2019
Brand Name +Dosage Form + Strength Revo Tablet 50mg
Eltrombopag as olamine…….50mg
Pharmacological Group Other systemic hemostatics
Type of Form Form 5
Approval status of product in PROMACTA® (eltrombopag asolamine) 50 mg film-coated
Reference Regulatory Authorities. tablets, for oral use. USFDA approved
Me-too status REVOLADE TABLETS 50MG. Reg. No. 69585
01.04.2019
Brand Name +Dosage Form + Strength Amlodip-H Tablet 10/12.5/160mg
Valsartan…..160mg
Hydrochlorthiazide……12.5mg
Type of Form Form 5
Approval status of product in EXFORGE HCT® Tablets by Novartis Pharmaceuticals
Reference Regulatory Authorities. Corporation. US-FDA approved
Me-too status Exforge HCT 10/160/12.5MG film coated tablets by Novatris
Pharma. Reg. No. 69550
01.04.2019
Brand Name +Dosage Form + Strength Amlodip-H Tablet 5/12.5/160mg
Valsartan…..160mg
Hydrochlorthiazide……12.5mg
Type of Form Form 5
01.04.2019
Brand Name +Dosage Form + Strength Amlodip-H Tablet 5/25/160mg
Valsartan…..160mg
Hydrochlorthiazide……25mg
Type of Form Form 5
Me-too status Exforge HCT 5/160/25MG film coated tablets by Novatris
01.04.2019
Valsartan…..160mg
Type of Form Form 5
01.04.2019
Valsartan…..320mg
Type of Form Form 5
01.04.2019
1203. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25 & 26, Street
Applicant No. S-3, RCCI, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Arize Tablets 15mg
Aripiprazole ……….15mg
Pharmacological Group Other antipsychotics
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s; As per SRO
Approval status of product in ABILIFY® (aripiprazole) Tablets. USFDA approved
Me-too status Raylify 15mg tablet. Reg. No. 66721
GMP status Last GMP inspection report dated 25.102.2018 declaring
following
Recommendations:
As the operations have not started as of yet at M/s Evolution
Pharmaceuticals, Rawat GMP status can only be ascertained upon
the start of active production, however: Keeping in view the
facility inspected the firm has requisite for manufacturing of
pharmaceuticals.
Brand Name +Dosage Form + Strength Lopirox Liquid 1.5%
Composition Contains:
Ciclopirox olamine……….1.5% (w/w)
Pharmacological Group Other antifungals for topical use
Type of Form Form 5
Pack size & Demanded Price 60ml, 90ml, 120ml; As per SRO
Approval status of product in Stieprox 15 mg/g Shampoo. HPRA approved
Me-too status Cicorox liquid. Reg. No. 82286
GMP status Last GMP inspection report dated 25.10.2018 declaring following
Recommendations:
As the operations have not started as of yet at M/s Evolution
Pharmaceuticals, Rawat GMP status can only be ascertained upon
the start of active production, however: Keeping in view the
facility inspected the firm has requisite for manufacturing of
pharmaceuticals.
 Decision: Deferred for further delibration.
Brand Name +Dosage Form + Strength Evocort 250mg Tablets
Sodium fusidate………250mg
Pharmacological Group Steroid antibacterials
Type of Form Form 5
Approval status of product in Fucidin 250 mg Tablets, film-coated. MHRA approved
Me-too status Pandate 250mg Tablets, film-coated. Reg. No. 81426
Remarks of the Evaluator.  Proof of approval of the section for the applied product was
asked from the firm. The firm submitted approval of general
section (tablet) section.
 Decision: Deferred for approval of steroid section.
Brand Name +Dosage Form + Strength Sedron 150mg Tablets
Risedronate sodium as hemi-pentahydrate………150mg
Pharmacological Group Bisphosphonates
Type of Form Form 5
Approval status of product in ACTONEL® (risedronate sodium) film-coated tablets. USFDA
Me-too status Udro-150mg film-coated Tablets. Reg. No. 80979
Brand Name +Dosage Form + Strength Dynacin Tablets 100mg
Minocycline as Hydrochloride…….100mg
Pharmacological Group Tetracyclines
Type of Form Form 5
Approval status of product in Minocycline 100 mg Film-coated Tablets. MHRA approved
Me-too status Myocin 100mg Tablet. Reg. No. 82288
Brand Name +Dosage Form + Strength Alendor Tablets 70mg
Alendronate Sodium Trihydrate eq. to Alendronic
Acid…….70mg
Type of Form Form 5
Approval status of product in FOSAMAX® (alendronate sodium) uncoated tablets, for oral
Reference Regulatory Authorities. use. USFDA approved
Me-too status Osoaid Tablets 70mg. Reg. No. 79761 ( does not trihydrate form)
Remarks of the Evaluator. .
Brand Name +Dosage Form + Strength Alendor-D Tablets
Alendronate Sodium Trihydrate eq. to Alendronic Acid….70mg
Cholecalciferol………………70mcg
Pharmacological Group Bisphosphonates, combination
Type of Form Form 5
Approval status of product in FOSAMAX® Plus D tablets. USFDA approved
Me-too status Alendix Tablets. Reg. No. 79781( does not trihydrate form)
Brand Name +Dosage Form + Strength Evotrol 2mg Tablets
Tolterodine tartrate………2mg
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form 5
Approval status of product in Detrusitol® 2 mg film-coated tablets. MHRA approved
Me-too status Ezeecon 2mg film-coated Tablets. Reg. No. 83232
Brand Name +Dosage Form + Strength Valamax 500mg Tablets
Valacyclovir as HCl………500mg
Type of Form Form 5
Approval status of product in VALTREX (valacyclovir hydrochloride) film-coated, capsule-
Reference Regulatory Authorities. shaped tablets. USFDA approved
Me-too status Viro Tablets 500mg. Reg. No. 43866 (does not depict film-
coated)
Brand Name +Dosage Form + Strength Selgene 5mg Tablets
Selegiline HCl………5mg
Pharmacological Group Monoamine oxidase B inhibitors
Type of Form Form 5
Approval status of product in ELDEPRYL® (Selegiline hydrochloride) 5mg Tablets. MHRA
Me-too status Elesen 5mg Tablets. Reg. No. 64657
Brand Name +Dosage Form + Strength Vabrilex 500mg Tablets
Vigabatrin………500mg
Pharmacological Group Fatty acid derivatives
Type of Form Form 5
Approval status of product in SABRIL® (vigabatrin) film-coated tablets, for oral use. USFDA
Me-too status Brizga 500mg film-coated Tablet. Reg. No. 82266
Brand Name +Dosage Form + Strength Fertex 50mg Tablets
Clomifene citrate………50mg
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form 5
Approval status of product in Clomid™ 50mg Tablets. MHRA approved
Me-too status Gynofen 50mg Tablet. Reg No. 53337
Decision: Registration Board approved registration of applied product in general manufacturing
areas with condition that manufacturer shall provide safety and protective measures for workers and
Brand Name +Dosage Form + Strength Solfena 10mg Tablets
Solifenacin succinate………10mg
Type of Form Form 5
Approval status of product in VESIcare (solifenacin succinate) film-coated 10mgtablets.
Me-too status Solfine film-coated Tablet 10mg. Reg No. 81959
Brand Name +Dosage Form + Strength Solfena 5mg Tablets
Solifenacin succinate………5mg
Type of Form Form 5
Approval status of product in VESIcare (solifenacin succinate) film-coated 5mgtablets.
Me-too status Solfine film-coated Tablet 5mg. Reg No. 81958
Brand Name +Dosage Form + Strength Galamin 4mg Tablets
Galantamine as hydrobromide………4mg
Pharmacological Group Anticholinesterases
Type of Form Form 5
Pack size & Demanded Price 10‘s, 14‘s, 20‘s, 28‘s; As per SRO
Approval status of product in REMINYL 4 mg film-coated tablets. ANSM approved
Me-too status Reminyl 4Mg Tablets. Reg No. 39801
Brand Name +Dosage Form + Strength Galamin 8mg Tablets
Galantamine as hydrobromide………8mg
Type of Form Form 5
Approval status of product in Galantamine 8 mg Film-coated Tablets. MHRA approved
Me-too status Reminyl 8mg Tablets. Reg No. 39802
Brand Name +Dosage Form + Strength Lamorig 25mg Tablets
Lamotrigine………25mg
Type of Form Form 5
Approval status of product in Lamictal 25 mg tablets. MHRA approved
Me-too status Sportin 25mg Tablets. Reg No. 70344
Type of Form Form 5
Type of Form Form 5
Brand Name +Dosage Form + Strength Eldon 4mg Tablets
Ondansetron as HCl dihydrate………4mg
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form 5
Pack size & Demanded Price 10‘s 20‘s, 30‘s; As per SRO
Approval status of product in Ondansetron 4 mg Film-coated Tablets. MHRA approved
Me-too status Ondan Tablet film-coated 4mg. Reg No. 82656
Brand Name +Dosage Form + Strength Eldon 8mg Tablets
Ondansetron as HCl dihydrate………8mg
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form 5
Pack size & Demanded Price 10‘s 20‘s, 30‘s; As per SRO
Approval status of product in Ondansetron 8 mg Film-coated Tablets. MHRA approved
Me-too status Ondan Tablet film-coated 8mg. Reg No. 82657
Brand Name +Dosage Form + Strength Alvert 8mg Tablets
Betahistine dihydrochloride………8mg
Type of Form Form 5
Approval status of product in Betahistine 8 mg uncoated tablets. MHRA approved
Me-too status Histogen 8mg Tablets. Reg No. 56090
Type of Form Form 5
Me-too status Histogen 16mg Tablets. Reg No. 56092
Type of Form Form 5
Me-too status Varsilla 24mg Tablet. Reg No. 76081
Brand Name +Dosage Form + Strength Amisyl 50mg Tablets
Amisulpride………50mg
Pharmacological Group Benzamides
Type of Form Form 5
Approval status of product in SOLIAN 50 amisulpride 50 mg uncoated tablet. TGA approved
Me-too status Ampisol 50mg Tablet. Reg No. 76060
Brand Name +Dosage Form + Strength Amisyl 100mg Tablets
Amisulpride………100mg
Pharmacological Group Benzamides
Type of Form Form 5
Approval status of product in SOLIAN 100 amisulpride 100 mg uncoated tablet. TGA
Me-too status Ampisol 100mg Tablet. Reg No. 76061

Brand Name +Dosage Form + Strength Ropilor 2mg Tablets
Ropinirole as HCl………2mg
Pharmacological Group Dopamine agonists
Type of Form Form 5
Approval status of product in REQUIP (ropinirole) 2mg film-coated tablets, for oral use.
Me-too status Balans 2mg Tablet. Reg No. 50558
Brand Name +Dosage Form + Strength Ropilor 1mg Tablets
Ropinirole as HCl………1mg
Type of Form Form 5
Approval status of product in REQUIP (ropinirole) 1mg film-coated tablets, for oral use.
Me-too status Balans 1mg Tablet. Reg No. 50564
Brand Name +Dosage Form + Strength Ropilor 0.25mg Tablets
Ropinirole as HCl………0.25mg
Type of Form Form 5
Approval status of product in REQUIP (ropinirole) 0.25mg film-coated tablets, for oral use.
Me-too status Balans 0.25mg Tablet. Reg No. 50557
Brand Name +Dosage Form + Strength Donaz Tablets 5mg
Donepezil HCl………5mg
Type of Form Form 5
Approval status of product in ARICEPT® (donepezil hydrochloride) 5mg film-coated tablets,
Me-too status Nepezil 5mg film-coated Tablet. Reg No. 83285
Brand Name +Dosage Form + Strength Donaz Tablets 10mg
Donepezil HCl………10mg
Type of Form Form 5
Approval status of product in ARICEPT® (donepezil hydrochloride) 10mg film-coated tablets,
Me-too status Nepezil 10mg film-coated Tablet. Reg No. 83286
Brand Name +Dosage Form + Strength Volric Tablets 200mg
Voriconazole………200mg
Pharmacological Group Triazole derivatives
Type of Form Form 5
Approval status of product in VFEND® (voriconazole) 200mg film-coated tablets, for oral use.
Me-too status Voric 200mg film-coated Tablet Reg No. 83272
Brand Name +Dosage Form + Strength Zonex Tablets 40mg
Esomeprazole as magnesium trihydrate………40mg
Type of Form Form 5
Approval status of product in NEXIUM 40MG gastro-resistant tablets. MHRA approved
Me-too status Ulcez 40mg Tablet. Reg No. 76085
Brand Name +Dosage Form + Strength Zonex Tablets 20mg
Esomeprazole as magnesium trihydrate………20mg
Type of Form Form 5
Approval status of product in NEXIUM 20MG gastro-resistant tablets. MHRA approved
Me-too status Ulcez 20mg Tablet. Reg No. 76084
Brand Name +Dosage Form + Strength Revlix Capsule 6mg
Rivastigmine as hydrogen tartrate………6mg
Type of Form Form 5
Approval status of product in EXELON® (rivastigmine tartrate) capsules, for oral use. USFDA
Me-too status Riveme 6mg Capsule. Reg. No. 79954
Brand Name +Dosage Form + Strength Revlix Capsule 3mg
Rivastigmine as hydrogen tartrate………3mg
Type of Form Form 5
Approval status of product in Rivastigmine 3 mg capsules. MHRA approved
Brand Name +Dosage Form + Strength Revlix Capsule 1.5mg
Rivastigmine as hydrogen tartrate………1.5mg
Type of Form Form 5
Approval status of product in Rivastigmine 3 mg capsules. MHRA approved
 Decision: Deferred for confirmation of generic and approval status of reference regulatory authorities.
Brand Name +Dosage Form + Strength Sunate Capsule 50mg
Sunitinib as malate………50mg
Pharmacological Group Protein kinase inhibitors
Type of Form Form 5
Approval status of product in SUTENT capsules 50mg. USFDA approved
Me-too status SUTENT 50MG CAPSULE. Reg. No. 52227
Remarks of the Evaluator.  The me-too product has mentioned Sunitinib malate instead
of Sunitinib as malate.
 The Registration Board in its 282nd meeting decided as:
―The manufacturing of cytotoxic drug shall be carried out in a
dedicated or self contained facilities and manufacturer‟s shall
provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close
handling of these drugs.
b. Anti-neoplastic Drugs (L01 class)” of WHO Anatomical
Therapeutic Chemical (ATC) classification (ATC) system shall be
considered as reference for categorization of drugs as
Cytotoxic/Antineoplastic‖
 As Sunitinib falls in Class L01, therefore, dedicated or self
contained facilities is required along with the provision of
safety and protective measures for workers and personnel
which remain in direct contact or are involved in close handling
of these drugs.
 Decision: Rejected due to non-availability of approved section
Brand Name +Dosage Form + Strength Sunate Capsule 25mg
Sunitinib as malate………25mg
Pharmacological Group Protein kinase inhibitors
Type of Form Form 5
Approval status of product in SUTENT capsules 25mg. USFDA approved
Me-too status SUTENT 25MG CAPSULE. Reg. No. 52226
Remarks of the Evaluator.  The me-too product has mentioned Sunitinib malate instead
of Sunitinib as malate.
 The Registration Board in its 282nd meeting decided as:
personnel which remain in direct contact or are involved in close
Therapeutic Chemical (ATC) classification (ATC) system shall be
considered as reference for categorization of drugs as
 As Sunitinib falls in Class L01, therefore, dedicated or self
contained facilities is required along with the provision of
safety and protective measures for workers and personnel
of these drugs.
 Decision: Rejected due to non-availability of approved section
Brand Name +Dosage Form + Strength Evogab Capsule 100mg
Gabapentin………100mg
Type of Form Form 5
Approval status of product in Gabapentin 100mg Capsules. MHRA approved
Me-too status Pentowan 100mg Capsule. Reg. No. 79688
Type of Form Form 5
Me-too status Pentowan 300mg Capsule. Reg. No. 82103
Type of Form Form 5
Me-too status Neogab 400mg Capsule. Reg. No. 32055
Brand Name +Dosage Form + Strength Ursicol Capsule 250mg
Type of Form Form 5
Brand Name +Dosage Form + Strength Ursicol Capsule 500mg
Type of Form Form 5
Approval status of product in Ursochol 500 mg capsule, hard. Swedish Medical Product
Reference Regulatory Authorities. Agency approved
Brand Name +Dosage Form + Strength Zonamid Capsule 25mg
Zonisamide…….25mg
PKR 20,000/-: 13.03.2018
Type of Form Form 5
Approval status of product in ZONISAMIDE 25 mg hard capsules. MHRA approved
Me-too status Zonisa 25mg Capsule. Reg. No. 58503

Type of Form Form 5
Type of Form Form 5
Brand Name +Dosage Form + Strength Valzip Capsule 20mg
Ziprasidone as HCl monohydrate…….20mg
Pharmacological Group ANTIPSYCHOTICS, Indole derivatives
Type of Form Form 5
Approval status of product in GEODON 20mg hard capsules. USFDA approved
Me-too status Prazip Capsule 20mg. Reg. No. 60393
Type of Form Form 5
Type of Form Form 5
Type of Form Form 5
Approval status of product in RRAs. GEODON 80mg hard capsules. USFDA approved
Brand Name +Dosage Form + Strength Thiox Capsule 4mg
Type of Form Form 5

Brand Name +Dosage Form + Strength Meconic Capsule 500mcg
Mecobalamin ……….500mcg
Type of Form Form 5
Approval status of product in Could not be confirmed
Me-too status Cobamin capsules. Reg. No. 22643
Decision: Deferred for Proof of International availability of same dosage form with same strength in
reference regulatory authority as defined in 275th meeting of the Registration Board.
Brand Name +Dosage Form + Strength Dobica Capsule 500mg
Calcium dobesilate monhydrate……….500mg
Pharmacological Group Other sclerosing agents
Type of Form Form 5
Approval status of product in Doxium ® 500 capsule. Swissmedic approved
Me-too status DOXIUM capsule 500mg. Reg. No. 23199
Brand Name +Dosage Form + Strength Loperiv Capsule 2mg
Loperamide HCl……............….2mg
Pharmacological Group Antipropulsives
Type of Form Form 5
Approval status of product in GASTRO-STOP loperamide hydrochloride 2mg capsules. TGA
Me-too status IMODIUM 2MG Capsule. Reg. No. 6159
Brand Name +Dosage Form + Strength Anquin Tablet 400mg
Norfloxacin……….............400mg
Type of Form Form 5
Approval status of product in Norfloxacin-ratiopharm® 400 mg tablets. MHRA approved
Me-too status Urac 400mg film-coated Tablets. Reg. No. 64219
Brand Name +Dosage Form + Strength Synflam Tablet 275mg
Naproxen sodium……….275mg
Pharmacological Group Propionic acid derivatives
Type of Form Form 5
Approval status of product in APRANAX 275 mg film-coated tablets. ANSM approved
Me-too status Calaxin Tablets. Reg. No. 74502
Brand Name +Dosage Form + Strength Epilene Plus Gel
Adapalene……….1mg
Benzoyl Peroxide……..25mg
Pharmacological Group adapalene, combinations
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g, 45g, 50g; As per SRO
Approval status of product in Epiduo 0.1% / 2.5% gel. MHRA approved
Me-too status Adoxide Gel. Reg. No. 85169
Brand Name +Dosage Form + Strength Epilene Gel 0.3%
Pharmacological Group Retinoids for topical use in acne
Type of Form Form 5
Approval status of product in Differin® 0.3% gel. USFDA approved
Me-too status Adapco Forte Gel. Reg. No. 83213
Brand Name +Dosage Form + Strength Epilene Gel 0.1%
Type of Form Form 5
Approval status of product in Differin® 0.1% gel. USFDA approved
Me-too status Semycin Gel. Reg. No. 78623
Brand Name +Dosage Form + Strength Epilene Cream 0.1%
Type of Form Form 5
Approval status of product in Differin 0.1% Cream. MHRA approved
Me-too status Adapal Cream 0.1%. Reg. No. 83838
Brand Name +Dosage Form + Strength Evonex Cream 0.005%
Calcipotriol as monohydrate……….0.05mg
PKR 20,000/-: 13.03.2018
Pharmacological Group Other antipsoriatics for topical use
Type of Form Form 5
Pack size & Demanded Price 15g, 30g; As per SRO
Approval status of product in Calcipotriol Cream 50 micrograms/g. MHRA approved
Me-too status Calcipot Cream Reg. No. 69823
Brand Name +Dosage Form + Strength Evonex Ointment 0.005%
Calcipotriol………...................0.05mg
Type of Form Form 5
Pack size & Demanded Price 15g, 30g; As per SRO
Approval status of product in DAIVONEX calcipotriol 50 micrograms/g ointment tube. TGA
Me-too status Sfonex Ointment. Reg. No. 85170
Brand Name +Dosage Form + Strength Silevo Cream 1%
Silver sulfadiazine……….10mg
Pharmacological Group Sulfonamides
Type of Form Form 5
Pack size & Demanded Price 10g, 20g, 250g, 500g; As per SRO
Approval status of product in Flamazine Cream 1.0%w/w. MHRA approved
Me-too status SILZIN CREAM Reg. No. 21193
Brand Name +Dosage Form + Strength Klotriz Cream 1%
Clotrimazole……….10mg
Pharmacological Group Imidazole and triazole derivatives
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 20g; As per SRO
Approval status of product in Clotrimazole 1% Cream. MHRA approved
Me-too status DERMOSPORIN (SKIN) CRM Reg. No. 8505
Brand Name +Dosage Form + Strength Femcin-V (vaginal) Cream 2%
Clindamycin as phosphate……….20mg
Pharmacological Group Antiinfectives for treatment of acne
Type of Form Form 5
Pack size & Demanded Price 40g; As per SRO
Approval status of product in Dalacin Cream 2%. MHRA approved
Me-too status Abwo Vaginal Cream 2% Reg. No. 82547
th
Brand Name +Dosage Form + Strength Acneza Cream 20%
Azelaic acid……….200mg
Pharmacological Group Other anti-acne preparations for topical use
Type of Form Form 5
Pack size & Demanded Price 5g, 10g, 15g, 20, 25g, 30g; As per SRO
Approval status of product in Skinoren 20% Cream. MHRA approved
Me-too status Skinex Cream Reg. No. 84452
Brand Name +Dosage Form + Strength Vabrilex Sachet 500mg
Vigabatrin……….500mg
Pharmacological Group ANTIEPILEPTICS, Fatty acid derivatives
Type of Form Form 5
Finished Product Specification Available in USP as ― for solution‖
Approval status of product in Sabril® 500 mg granules for oral solution. MHRA approved
Reference Regulatory Authorities. (granular powder)
Me-too status Vlep 500mg Sachet Reg. No. 70474
Remarks of the Evaluator.  The me-too product does not clarify whether the content is
granules or powder.
 The USP has used the term powder in the assay procedure
and did not mention dissolution test thereof.
 Decision: Deferred for clarification from the firm.
Brand Name +Dosage Form + Strength Vofen Sachet 600mg
Ibuprofen……….600mg
PKR 20,000/-: 13.03.2018
Pharmacological Group Propionic acid derivatives
Type of Form Form 5
Approval status of product in Brufen® 600mg Effervescent Granules. MHRA approved
Me-too status Brufen 600mg Sachet Reg. No. 44414
Remarks of the Evaluator.  The me-too product does not clarify whether the content is
granules or powder.
 Decision: Deferred for clarification.
Brand Name +Dosage Form + Strength Volric Dry suspension 200mg/5ml
Composition Each 5ml (after reconstitution) contains:
Voriconazole……….200mg
Pharmacological Group Triazole derivatives
Type of Form Form 5
Pack size & Demanded Price 60ml, 75ml, 90ml; As per SRO
Approval status of product in Voriconazole Pfizer 40 mg/ml powder for oral suspension.
Reference Regulatory Authorities. MHRA approved
Me-too status Voric 200mg/5ml Suspension. No. 83917
Remarks of the Evaluator.  The me-too data does not clarify whether the product is
suspension or ‗powder for suspension‘.
 Decision: Deferred for clarification.
1273. Name and address of manufacturer / McOLSON Research Laboratories (Pvt.) Ltd 26th Km. Lahore-
Applicant Sharikpur Road Distt. Sheikhupura
Brand Name +Dosage Form + Strength Racitam 250mg tablet
Levetiracetam….250mg
Type of Form Form 5
GMP status ―Last GMP inspection report dated 15-02-2018 declaring
following ― General Observations‖:
―HVAC system is properly installed and functional in all
production areas. Overall cleanliness of the plant is good. Flow
of personal movement, material movement and process is as per
cGMP. The firm has sufficient production capacities for
manufacturing of different products in all sections. However the
firm was advised to improve documentation system regarding
validation of testing procedure and manufacturing procedure.‖
Brand Name +Dosage Form + Strength Racitam 500mg tablet
Levetiracetam….500mg
PKR 20,000/-: 14.03.2018
Type of Form Form 5
Brand Name +Dosage Form + Strength M-Gab 75mg Capsule
Pregabalin….75mg
Type of Form Form 5
Brand Name +Dosage Form + Strength McProx 20mg Tablet
Composition Each film-coated contains:
Paroxetine as HCl hemihydrate….20mg
Type of Form Form 5
Approval status of product in Paroxetine 20 mg Film-coated tablets. MHRA approved
Me-too status Frais Tablet 20mg. Reg. No. 82658 (Does not depict
hemihydrate)
Remarks of the Evaluator. Firm revised Paroxetine as HCl to Paroxetine as HCl hemihydrate
1277. Name and address of manufacturer / M/s Farm Aid Group. Plot # 3/2, Phase I & II, Hattar Industrial
Applicant Estate, Haripur
Brand Name +Dosage Form + Strength Usodex 250mg Capsule
Ursodeoxycholic acid…250mg
Type of Form Form 5
GMP status The firm was inspected on 07.09.2017, wherein the following
Observations/ Recommendations were made:
"1- Improve quality assurance system as per GMP
GUIDELINES.
2- Develop annual product review system for marketed products.
Overall the firm was working under satisfactory level of GMP."
1278. Name and address of manufacturer / M/s Farm Aid Group. Plot # 3/2, Phase I & II, Hattar Industrial
Applicant Estate, Haripur
Brand Name +Dosage Form + Strength Dia-Farm 50mg Capsule
Diacerein…50mg
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-steroids
Type of Form Form 5
Approval status of product in ART 50 mg capsule. ANSM approved
Me-too status Diora 50mg Capsule. Reg. No. 67631
1279. Name and address of manufacturer / M/s Kaizen Pharmaceuticals Pvt Ltd. E-127-129, North Western
Applicant Industrial Zone, Bin Qasim, Karachi
Brand Name +Dosage Form + Strength Torfen 100mg/5ml Liquid Suspension
Ibuprofen…100mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml; as per PRC
Approval status of product in Proven oral suspension ibuprofen 20mg/mL oral liquid bottle.
Me-too status Azofin Suspension. Reg. No. 20860
conclusion; ―The building facilities and procedures demonstrated
at the time of inspection found at satisfactory level of GMP
compliance. Moreover, firm should focus on above mentioned
observations and comply with them on priority basis.‖
1280. Name and address of manufacturer / M/s Honig Pharmaceuticals Labs. – Rawalpindi 14 KM, Adyala
Applicant Road, Rawalpindi; contract manufacturing by: Vision
Pharmaceuticals Plot # 22-23, Industrial Triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength SEC 40mg IV Injection
Omeprazole as sodium……40mg
Type of Form Form 5
Approval status of product in OMEPRAZOLE SANDOZ IV omeprazole (as sodium) 40mg
Reference Regulatory Authorities. powder for injection vial. TGA approved
Me-too status Somezol Injection. Reg. No. 45386
GMP status The firm M/s Vision Pharmaceuticals was inspected on
11.02.2019, wherein the panel recommended the grant of GMP
certificate.
The firm M/s Honig Pharmaceuticals was inspected on
11.10.2018 and reported complying GMP.
Remarks of the Evaluator.  The shelf-life of the product in TGA is 18 months.
 The firm M/s Honig Pharmaceuticals has submitted inspection
report for DML renewal, wherein 04 sections have been
mentioned.
 The firm M/s Honig Pharmaceuticals has submitted a list of 09
approved product for contact manufacturing.
products applied for contact manufacturing by M/s Honig
Pharmaceuticals.
 Adjustment of weight of API as per salt factor is required in
Master Formula.
 The firm has mentioned the dosage form as injection. However,
the composition and manufacturing outlines depict that the
product is lyophilized powder for injection.
 The firm has provided copy of contract manufacturing
agreement between the applicant and manufacturer.
 The firm was asked to clarify the lyophilization process, but the
firm did not reply.
 Decision: Deferred for the following:
 Adjustment of weight of API as per salt factor is required in Master Formula.
 Clarify whether the product is filled and lyophilized or only lyophilized powder is filled.
 Clarify the dosage form.
Islamabad
Brand Name +Dosage Form + Strength Moxing 400mg/250ml IV Injection
Moxifloxacin as HCl……400mg
PKR 50,000/-: 14.03.2018
Type of Form Form 5
Pack size & Demanded Price (250ml) 1‘s; As per SRO
Approval status of product in AVELOX IV 400 moxifloxacin 400 mg/250 mL (as
Reference Regulatory Authorities. hydrochloride) intravenous infusion solution bottle. TGA
approved
Me-too status Esobrain Injection 40mg. Reg. No. 85072
GMP status
Remarks of the Evaluator.  The firm M/s Honig Pharmaceuticals has submitted inspection
mentioned.
Pharmaceuticals.
 The firm mentioned HDPE as primary packaging. Then
changed to LDPE). The reference product is packed in Glass
Type I clear bottle.
 The firm was asked for adjustment of weight of API as per salt
factor. The firm did not revised the same.
Decision: Deferred for clarification about the packaging.
Islamabad
Brand Name +Dosage Form + Strength Xamp 40mg IV Injection
Esomeprazole as sodium……40mg
Type of Form Form 5
Pack size & Demanded Price 1‘s; As per DPC
Approval status of product in NEXIUM IV esomeprazole 40mg (as sodium) powder for
Reference Regulatory Authorities. injection vial. TGA approved
Me-too status Somezol Injection. Reg. No. 45386
GMP status
Remarks of the Evaluator.  The firm M/s Honig Pharmaceuticals has submitted inspection
mentioned.
Pharmaceuticals.
the composition and manufacturing outlines depict that the
product is lyophilized powder for injection.
 Adjustment of weight of API as per salt factor is required in
Master Formula.
 The firm has mentioned 33% potency of lyophilized powder,
but did not clarify the other 67% composition.
 The firm was asked to clarify the lyophilization process, but the
firm did not reply.
 Decision: Decision: Deferred for the following:
 Adjustment of weight of API as per salt factor is required in Master Formula.
 Clarification whether the product is filled and lyophilized or only lyophilized powder is filled.
 Clarification of the dosage form.
 Clarification about the composition of the dosage form (powder).
1283. Name and address of manufacturer / Navegal Laboratories 41/1-A2, Phase-1, Industrial Estate Hattar
Applicant
Brand Name +Dosage Form + Strength Oslu 75mg Capsule
Oseltamivir as phosphate…..75mg
PKR 20,000/-: 28.11.2018
Pharmacological Group Neuraminidase inhibitors
Type of Form Form 5
Pack size & Demanded Price 1x10‘s, 2x10‘s; As per SRO
Approval status of product in TAMIFLU® (oseltamivir phosphate) capsules, for oral use.
Me-too status Tamiflu 75Mg Capsules. Reg. No. 39619
GMP status The firm was inspecvted on 31.12.2016, wherein renewal of
DML was recommended.
 Decision: Deferred for consideration on its its turn.
Applicant
Brand Name +Dosage Form + Strength Cinapar 90mg Tablet
Cinacalcet as HCl…..90mg
Pharmacological Group Other anti-parathyroid agents
Type of Form Form 5
Pack size & Demanded Price 1x10‘s, 1x15‘s, 2x10‘s, 2x15‘s; As per SRO
Approval status of product in Cinacalcet 90 mg film-coated tablets. MHRA approved
 Decision: Deferred for submission of stability studies.
Applicant
Type of Form Form 5
Applicant
Type of Form Form 5
1287. Name and address of manufacturer / M/s Winthrox Laboratories (Pvt) Ltd. K-219-A, SITE, Super
Applicant Highway, Phase-II, Karachi-Contract Manufacturing by: M/s
Global Pharmaceuticals (Pvt) ltd. Plot No. 204-205, Industrial
Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Menem Powder for solution for injection 500mg
Meropenemas as trihydrate……500mg
Pharmacological Group Carbapenems
Type of Form Form 5
Pack size & Demanded Price 1‘s vial; As per DRAP policy
Approval status of product in MERREM® IV (meropenem for injection) 500mg, for
Reference Regulatory Authorities. intravenous use. US-FDA approved
Me-too status Engpan Injection 500mg. Reg. No. 64555
Remarks of the Evaluator.  List of already approved product for contact manufacturing of
M/s Winthrox Laboratories is required.
 List of product applied for contact manufacturing by M/s
Winthrox Laboratories is required.
 List of all approved sections of M/s Winthrox Laboratories is
required.
 The firm has mentioned the dosage form as injection.
However, firm revised it to Powder for solution for injection.
 List of already approved product for contact manufacturing of M/s Winthrox Laboratories is
required.
 List of product applied for contact manufacturing by M/s Winthrox Laboratories is required.
 List of all approved sections of M/s Winthrox Laboratories is required.
Brand Name +Dosage Form + Strength Menem Powder for solution for injection 1g
Meropenem as trihydrate……1g
Type of Form Form 5
Approval status of product in MERREM® IV (meropenem for injection) 1g, for intravenous
Reference Regulatory Authorities. use. US-FDA approved
Me-too status Meropeon Injection 1g. Reg. No. 78145
required.
the firm revised it to Powder for solution for injection.
required.

Brand Name +Dosage Form + Strength Tazowin Powder for solution for injection 4.5g
Piperacillin as sodium……4g
Tazobactam as sodium……0.5g
Pharmacological Group Piperacillin and beta-lactamase inhibitor
Type of Form Form 5
Approval status of product in ZOSYN® (piperacillin and tazobactam) for injection, for
Reference Regulatory Authorities. intravenous use. US-FDA approved
Me-too status Tanzo Injection. Reg. No. 39439
required.
firm now revised it to Powder for solution for injection
required.
Brand Name +Dosage Form + Strength Tazowin Powder for solution for injection 2.25g
Piperacillin as sodium……2g
Tazobactam as sodium……0.25g
Pharmacological Group Piperacillin and beta-lactamase inhibitor
Type of Form Form 5
Approval status of product in ZOSYN® (piperacillin and tazobactam) for injection, for
Reference Regulatory Authorities. intravenous use. USFDA approved
Me-too status Tanzo Injection. Reg. No. 39593
Remarks of the Evaluator.  Tazowin 2.5 has been mentioned on fee challan instead of
Tazowin 2.25
 List of already approved product for contact manufacturing of
required.
 Submission of undertaking about the fee challan.
required.
Brand Name +Dosage Form + Strength Imicil Powder for solution for injection
Imipenem as monohydrate…..500mg
Cilastin as sodium………500mg
Type of Form Form 5
Approval status of product in PRIMAXIN® (imipenem and cilastatin) for Injection, for
Reference Regulatory Authorities. intravenous use. USFDA approved
Me-too status Imclas Injection IV. Reg. No. 48341
required.
 List of already approved product for contact manufacturing of M/s Winthro x Laboratories is
required.
1292. Name and address of manufacturer / Genetics Pharmaceuticals (Pvt.) Limited., 539-A, Sunder
Applicant Industrial Estate Raiwand Road Lahore
Brand Name +Dosage Form + Strength Entrate 70mg Tablet
Alendronate Sodium Trihydrate eq. to Alendronic Acid….70mg
Type of Form Form 5
Pack size & Demanded Price 4‘s, 10‘s; as per SRO
Approval status of product in FOSAMAX® (alendronate sodium) uncoated tablets, for oral
Me-too status Osoaid Tablets 70mg. Reg. No. 79761 ( does not trihydrate form)
GMP status The firm was inspected on 29.03.2019, wherein the panel
concluded that the firm is operating at satisfactory level of GMP
compliance.

Brand Name +Dosage Form + Strength Revalp 250mg ER Tablet
Divalproex sodium eq. to Valproic acid……250mg
Type of Form Form 5
Approval status of product in Depakote® ER Divalproex sodium extended-release 250mg
Reference Regulatory Authorities. tablets. USFDA approved with box warning
concluded that the firm is operating at satisfactory level of GMP
compliance.
Remarks of the Evaluator.  Adjust weight of API in Master Formula as per salt factor.
 Proof of approval of me-too product with same dosage form,
strength and salt form by DRAP is required.
 Adjustment of weight of API in Master Formula as per salt factor.
 Proof of approval of me-too product with same dosage form, strength and salt form by DRAP is
required.
Brand Name +Dosage Form + Strength Revalp 500mg ER Tablet
Divalproex sodium eq. to Valproic acid……500mg
Type of Form Form 5
Approval status of product in Depakote® ER Divalproex sodium extended-release 500mg
Reference Regulatory Authorities. tablets. USFDA approved with box warning
Me-too status Volpar CR 500mg Tablets. Reg. No. 73237
1295. Name and address of manufacturer / Werrick Pharmaceuticals, 216-217, I-10/3, Industrial Area,
Applicant Islamabad
Brand Name +Dosage Form + Strength Flueze DS Expectorant (flavored liquid)
Composition Each 20ml contain:
Acetaminophen…..650mg
Phenylephrine………10mg
Dextromethorphan HBr…….20mg
Guaifenesin………400mg
Pharmacological Group Analgesic + decongestant + cough suppressant + expectorasnt
(not in ATC)
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer specifications
Pack size & Demanded Price 120ml; As per SRO
GMP status The firm was inspected on 09.11.2018, wherein grant of GMP
certificate was recommended.
Remarks of the Evaluator. Facility for water processing with details is required.
 Proof of approval of me-too product with same dosage form, strength and salt form by DRAP.
 Proof of International availability of same dosage form with same strength in reference regulatory
authority as adopted in 275th meeting of the Registration Board.
 Facility for water processing with details.
Applicant Islamabad
Brand Name +Dosage Form + Strength Flueze Plus Expectorant (flavored liquid)
Guaifenesin………200mg
Pharmacological Group dextromethorphan, combinations
Type of Form Form 5
Remarks of the Evaluator. Facility for water processing with details is required.
Applicant Islamabad
Brand Name +Dosage Form + Strength Flueze Plus cough syrup
Doxylamine Succinate…….12.5mg
Type of Form Form 5
Remarks of the Evaluator.  Facility for water processing with details is required.
Applicant Islamabad
Brand Name +Dosage Form + Strength Flueze cough syrup
Type of Form Form 5
Remarks of the Evaluator.  Facility for water processing with details is required.
1299. Name and address of manufacturer / Zafa Pharmaceutical Laboratories (Private) Limited A-46, SITE
Applicant North Karachi
Brand Name +Dosage Form + Strength Dydrone Tablet 10mg
Dydrogesterone…….10mg
Pharmacological Group Progestogens
Type of Form Form 5
Approval status of product in Duphaston 10 mg film-coated tablets. Approved in Belgium
Me-too status D-Gest 10mg Tablets. Reg. No. 77100
GMP status The firm was inspected on 07.02.2019, wherein the GMP was
rated as GOOD
Remarks of the Evaluator.  The firm submitted that they will use trans-isomer of API.
 Decision: Deferred for confirmation of approval of the section.
1300. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd., Plot # 549, Sundar Industrial Estate,
Applicant Raiwand Road, Lahore
Brand Name +Dosage Form + Strength Trexate 2.5mg Tablet
Methotrexate……..2.5mg
PKR 20,000/-: 28.11.2018
Pharmacological Group Other immunosuppressants (L04AX03)
Type of Form Form 5
Approval status of product in Maxtrex 2.5 mg un-coated tablets. MHRA approved
Me-too status METHOTREXATE TABLET 2.5MG. Reg. No. 66007
GMP status The firm has been issued DML on the basis of inspection dated
13.07.2017 and 04.10.2017.
Remarks of the Evaluator.  The Registration Board in its 282nd meeting decided as:
personnel which remain in direct contact or are involved in
close handling of these drugs.
Therapeutic Chemical (ATC) classification (ATC) system shall
be considered as reference for categorization of drugs as
 As methotrexate also falls in Class L01, therefore, dedicated
or self contained facilities is required along with the provision
of safety and protective measures for workers and personnel
of these drugs.
1301. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd., Plot # 549, Sundar Industrial Estate,
Applicant Raiwand Road, Lahore
Brand Name +Dosage Form + Strength Trexate 10mg Tablet
Methotrexate……..10mg
Pharmacological Group Other immunosuppressants (L04AX03)
Type of Form Form 5
Approval status of product in Maxtrex 10 mg un-coated tablets. MHRA approved
Me-too status METHOTREXATE TABLET 10MG. Reg. No. 66009
GMP status The firm has been issued DML on the basis of inspection dated
13.07.2017 and 04.10.2017.
Remarks of the Evaluator. ―The manufacturing of cytotoxic drug shall be carried out in a
Therapeutic Chemical (ATC) classification (ATC) system shall
be considered as reference for categorization of drugs as
 As methotrexate also falls in Class L01 , therefore, dedicated
or self contained facilities is required along with the provision
of safety and protective measures for workers and personnel
of these drugs.
1302. Name and address of manufacturer / M/s Welwrd Pharmaceuticals. Plot # 3, Block A, Phase I-II,
Applicant Industrial Estate Hattar, KPK
Brand Name +Dosage Form + Strength Terbiwrd 250mg Tablet
Terbinafine as HCL…250mg
Pharmacological Group Antifungals for systemic use
Type of Form Form 5
Approval status of product in LAMISIL terbinafine 250mg (as hydrochloride) tablet,
Reference Regulatory Authorities. uncoated. TGA approved
Me-too status Terbin DS Tablets 250mg. Reg. No. 49235
GMP status Inspection was conducted on 12.11.2018, wherein the following
sections of the firm were considered to be operating at
satisfactory level of GMP.

i) Tablet Section (General/antibiotics)
ii) Liquid injectable section (General/antibiotics)
iii) Dry injectable section (General/antibiotics)
iv) Dry powder injectable (cephalosporins)
While the remaining sections viz Capsule general, dry powder
suspension general and Sachet sections were observed with
certain shortcomings that need to be rectified.
1303. Name and address of manufacturer / M/s Weather Folds Pharmaceuticals. Plot # 69, Phase-II,
Applicant Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Simcol 40mg Oral Drops
Simethicone…40mg
Pharmacological Group Antiflatulent
Type of Form Form 5
Approval status of product in Reference Infacol 40mg/ml oral drops (suspension). MHRA approved
Me-too status Minicol Drops. Reg. No. 36627
recommended the grant of GMP certificate.
1304. Name and address of manufacturer / Aspin Pharma (Pvt.) Ltd., Plot No. 10 & 25, Sector 20, Korangi
Applicant Industrial Area, Karachi 74900, Pakistan
Brand Name +Dosage Form + Strength Athrocin DS
Azithromycin as dihydrate……200mg
Type of Form Form 5
Pack size & Demanded Price 15ml, 25ml; As per DPC
Approval status of product in Azithromycin 200 mg/5 ml Suspension. MHRA approved
Me-too status Chemzee Dry Powder Suspension. Reg. No. 35875
GMP status The firm was inspected on 20.02.2018, wherein the GMP level
was rated as satisfactory.
Remarks of the Evaluator.  The USP has specified Amperometric electrochemical detector
with Dual glassy carbon Electrode. The firm was asked for
provision of the same. The firm did not respond.
 The firm has mentioned the dosage form as suspension instead
of dry suspension in Form 5.
Decision: Deferred for provision of provision of Amperometric electrochemical detector with Dual
glassy carbon Electrode
Brand Name +Dosage Form + Strength AMLO 2.5mg Tablet
Amlodipine as besylate……2.5mg
Pharmacological Group Dihydropyridine derivatives
Type of Form Form 5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s; As per DPC
Approval status of product in NORVASC® (amlodipine besylate) 2.5mg Tablets for oral
Reference Regulatory Authorities. administration. USFDA approved
Me-too status Amlocard 2.5 Tablets Reg. No. 20554
Brand Name +Dosage Form + Strength AMLO 5mg Tablet
Type of Form Form 5
Approval status of product in NORVASC® (amlodipine besylate) 5mg Tablets for oral
Me-too status Amlocard 5 Tablets Reg. No. 20555
Brand Name +Dosage Form + Strength AMLO 10mg Tablet
Type of Form Form 5
Approval status of product in NORVASC® (amlodipine besylate) 10mg Tablets for oral
Me-too status Amlocard 10 Tablets Reg. No. 20556
Brand Name +Dosage Form + Strength Athrocin 250mg Tablet
Azithromycin as dihydrate ……250mg
Type of Form Form 5
Approval status of product in ZITHROMAX (azithromycin) 250 mg film-coated tablet.
Me-too status Macrocap film-coated 250mg Tablets. Reg. No. 84260
Brand Name +Dosage Form + Strength Athrocin 500mg Tablet
Azithromycin as dihydrate……500mg
Type of Form Form 5
Approval status of product in ZITHROMAX (azithromycin) 500 mg film-coated tablet.
Me-too status Macrocap film-coated 500mg Tablets. Reg. No. 84261
Brand Name +Dosage Form + Strength Athrocin 100mg/5ml Dry Suspension
Azithromycin as dihydrate ……100mg
Type of Form Form 5
Pack size & Demanded Price 15ml, 25ml; As per DPC
Approval status of product in ZITHROMAX (azithromycin) 100mg/5ml suspension. USFDA
Me-too status Azitma 100mg/5ml Suspension. Reg. No. 74901
Remarks of the Evaluator.  The USP has specified Amperometric electrochemical detector
with Dual glassy carbon Electrode. The firm was asked for
provision of the same. The firm did not respond.
 The firm has mentioned the dosage form as suspension instead
of dry suspension in Form 5.
Brand Name +Dosage Form + Strength Drotaspin 40mg Tablet
Drotaverine HCl ……40mg
Pharmacological Group Papaverine and derivatives
Type of Form Form 5
Finished Product Specification The firm ahs claimed in-house specifications
Approval status of product in Apporved in three EMA states as un-coated tablets in
Reference Regulatory Authorities. Hungary (both coated and uncoated), Romania & Solvakia (both
coated and uncoated).
Me-too status Spasmostar Tablets. Reg. No. 78711
Remarks of the Evaluator. The firm was asked to provide complete finished product
specifications in line with General chapters of pharmacopeia (list
of tests, reference to analytical procedures, and proposed
acceptance criteria). Firm submitted incomplete specifications.
1312. Name and address of manufacturer / Global Pharmaceuticals Plot # 204-205, Industrial triangle,
Applicant Kahuta Road, Islamabad; Contract manufacturing by Vision
Pharmaceuticals Plot #22-23, Industrial triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength Neuro Vita 3ml Injection
Composition Each 03 ml ampoule contains:
Thiamine chloride HCl …..100mg
Pyridoxine HCl ….100mg
Vitamin B12…..1000mcg
PKR 30,000/-: 18.04.2019
Pharmacological Group Vitamins
Type of Form Form 5
Pack size & Demanded Price 3ml x 25‘s; As per SRO
Approval status of product in Reference Neurobion® solution for injection. DIMDI Germany approved
Me-too status NEUROBION INJ. Reg. No. 1485
GMP status The firm M/s Vision Pharma was inspected on 11.02.2019,
wherein issuance of GMP certificate was recommended.
The firm M/s Global Pharma was inspected on 11. &
24.10.2018, wherein issuance of GMP certificate was
recommended.
Remarks of the Evaluator.  Fee of Rs. 20,000 has been submitted by Vision
Pharmaceuticals. While fee of Rs. 30000/- has been submitted
by Global Pharma.
 In the agreement, it has been mentioned that the agreement is
signed in the presence of witnesses. However, names and
signatures (thumb impressions) of witnesses are not present
thereof.
 First page of Form 5 shall be signed M/s Global
Pharmaceuticals.
 The firm has revised thiamine to thiamine chloride HCl
without submission of fee.
 The firm has revised to pyridoxine to pyridoxine HCl without
submission of fee.
 Decision: Registration Board decided to refer the case to Division of Legal Affairs (DRAP) for
clarification of the following:
 Fee of Rs. 20,000 has been submitted by Vision Pharmaceuticals. While fee of Rs. 30000/- has been
submitted by Global Pharma.
 In the agreement, it has been mentioned that the agreement is signed in the presence of witnesses.
However, names and signatures (thumb impressions) of witnesses are not present thereof.
 The firm has revised thiamine to thiamine chloride HCl without submission of fee.
 The firm has revised to pyridoxine to pyridoxine HCl without submission of fee.
1313. Name and address of manufacturer / M/s AGP Limited. B-23, S.I.T.E. Karachi
Applicant
Brand Name +Dosage Form + Strength Dotril 10mg Sachet
Racecadotril…..10mg

Diary No. Date of R& I & fee Dy No. 15146: 24.04.2018 PKR 50,000 +10,000/-: 23.04.2018
(For Dotril 10mg Sachet + Dotril 30mg Sachet + Dotril 100mg
Capsule)
Pharmacological Group Other antidiarrheals
Type of Form Form 5
Pack size & Demanded Price 16‘s; Rs. 875
Approval status of product in TIORFAN 10 mg INFANTS, oral powder in sachet-dose. ANSM
Reference Regulatory Authorities. Approved
HIDRASEC INFANTS 10 mg, Granules for oral suspension.
MHRA approved (the pharmaceutical form is Granules for oral
suspension White powder with characteristic apricot smell)
Applicant
Brand Name +Dosage Form + Strength Dotril 30mg Sachet
Racecadotril…30mg
PKR 50,000 +10,000/-: 23.04.2018 (For Dotril 10mg Sachet +
Dotril 30mg Sachet + Dotril 100mg Capsule)
Type of Form Form 5
Pack size & Demanded Price 16‘s; Rs. 875 (to avoid confusion; same as for 10mg)
Approval status of product in TIORFAN 30 mg CHILDREN, oral powder in sachet-dose.
Reference Regulatory Authorities. ANSM Approved
HIDRASEC CHILDREN 30 mg, Granules for oral suspension.
MHRA approved (the pharmaceutical form is Granules for oral
suspension White powder with characteristic apricot smell)
Remarks of the Evaluator.  Provide complete finished product specifications in line with
general chapters (list of tests, reference to analytical
procedures, and proposed acceptance criteria), including tests
for granules.
Applicant
Brand Name +Dosage Form + Strength Dotril 100mg capsule
Racecadotril…100mg
PKR 50,000 +10,000/-: 23.04.2018 (For Dotril 10mg Sachet +
Dotril 30mg Sachet + Dotril 100mg Capsule)
Type of Form Form 5
Pack size & Demanded Price 10‘s; Rs. 654
Approval status of product in HIDRASEC 100 mg hard capsules. MHRa approved

Applicant
Brand Name +Dosage Form + Strength Emerep 40mg Capsule
Aprepitant…40mg
Pharmacological Group Other antiemetics
Type of Form Form 5
Approval status of product in EMEND (aprepitant) 40mg capsules, for oral use. USFDA
Me-too status Apreon 40mg Capsules. Reg. No. 68201
 Decision:
Applicant
Aprepitant…80mg
Type of Form Form 5
Pack size & Demanded Price 6‘s; Rs.7967.24/-
Applicant
Aprepitant…125mg
Type of Form Form 5
Applicant
Brand Name +Dosage Form + Strength Choir 1mg/ml Oral Solution
Risperidone…1mg
Type of Form Form 5
Pack size & Demanded Price 30ml; Rs. 189/-
Approval status of product in RISPERDAL® (risperidone) oral solution. USFDA approved.
1320. Name and address of manufacturer / M/s Mediate Pharmaceutical Pvt Ltd. Plot No. 150-151, Sector
Applicant 24, Korangi Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Res-Med 2mg Tablet
Risperidone.............…2mg
Type of Form Form-5
Approval status of product in RISPERDAL® (risperidone) 2mg tablets, for oral use. USFDA
Me-too status Rislet 2mg Tablet. Reg. No. 76412
GMP status The firm was inspected on 15.02.2017 wherein the firm was
considered to be operating at acceptable level of compliance with
GMP guidelines.
Remarks of the Evaluator. The firm had provided international availability of film-coated
tablet, but did not mention label claim and coating composition in
Master Formula. However, coating process is present in
manufacturing outlines. Upon clarification, the firm revised all the
required documents to film-coated tablet with submission of
Rs.5,000/- fee.

Brand Name +Dosage Form + Strength Res-Med 1mg Tablet
Risperidone…1mg
Type of Form Form 5
Approval status of product in RISPERDAL® (risperidone) 1mg tablets, for oral use. USFDA
Me-too status Rislet 1mg Tablet. Reg. No. 76417
Remarks of the Evaluator. The firm had provided international availability of film-coated
tablet, but did not mention label claim and coating composition in
Master Formula. However, coating process is present in
manufacturing outlines. Upon clarification, the firm revised all the
required documents to film-coated tablet with submission of
Rs.5,000/- fee.
Decision: Approved.

Brand Name +Dosage Form + Strength Megrital 400mg Tablet
Carbamazepine…..400mg
Type of Form Form 5
Me-too status Tegral 400mg Tablet. Reg. No. 79918 (does not depict coating)
Remarks of the Evaluator.  Clarification is required about solvent-E.
 The firm revised the formulation from coated tablet to un-
caoted tablet with submission of Rs. 5000/- fee.
 Decision: Deferred for clarification about solvent-E.
Brand Name +Dosage Form + Strength Topage 50mg Tablet
Topiramate …..50mg
Type of Form Form 5
Approval status of product in Topamax® 50 mg film-coated tablets. MHRA approved
Me-too status Topister Tablet 50mg. Reg. No. 82548
Brand Name +Dosage Form + Strength Solvent (Water for Injection) 10ml Type I glass
Composition Each ampule contains:
Sterile water for Injection …..10ml
Pharmacological Group Solvents and diluting agents, incl. irrigating solutions
Type of Form Form 5
Pack size & Demanded Price 10ml, As per DRAP Policy
Approval status of product in STERILE WATER FOR INJECTION 100% (10ml) in vial.
Me-too status Water for Injection (sterile) 10ml in ampule. Reg. No. 76972
Type of Form Form 5
Approval status of product in Water for Injections BP (sterile injection) 2ml ampule. MHRA
Me-too status Water for Injection (sterile) 2ml (ampule). Reg. No. 76466
Type of Form Form 5
Approval status of product in Water for Injections BP 5ml. MHRA approved. Could not be
Reference Regulatory Authorities. confirmed in the applied volume, i.e., 3ml
Brand Name +Dosage Form + Strength Solvent 5 ml (Type I glass ampule) for Medisonate Injection
Composition Each 5ml ampule contains:
Sodium chloride…..0.9%
Pharmacological Group Electrolyte solutions
Type of Form Form 5
Approval status of product in Sodium Chloride 0.9% w/v Injection BP 5 ml in hermitically
Reference Regulatory Authorities. sealed translucent plastic ampule. MHRA approved.
Remarks of the Evaluator. The firm mentioned sodium hydroxide and HCl for pH
adjustment in manufacturing outlines. However, these are not
present in Master formula. The firm was asked for justification in
line with the reference product. The firm did not reply.
 Decision: Deferred for further clarification/revision of formulation.
Brand Name +Dosage Form + Strength Solvent 1 ml (Type I glass ampule) for Medisonate Injection
Sodium bicarbonate…..5%
Pharmacological Group Electrolyte solutions
Type of Form Form 5
Finished Product Specification ???
Me-too status Sodium Bicarbonate Injection. Reg. No. 76428 (does not specify
the pack volume)
Remarks of the Evaluator.  The firm has mentioned sodium hydroxide and HCl for pH
adjustment in manufacturing outlines. However, these are not
present in Master formula. Justification in line with the
reference product is required.
 Complete finished product specifications in line with general
chapters of pharmacopeia (list of tests, reference to analytical
procedures, and proposed acceptance criteria) are required.
 Decision: Deferred for the following.
 Complete finished product specifications in line with general chapters of pharmacopeia (list of
tests, reference to analytical procedures, and proposed acceptance criteria) are required.
Applicant Karachi, 75190, Pakistan. Contract munafacturing by: M/s
Daneen Pharma (Pvt) Ltd. 27, Sundar industrial Estate, Sundar
Raiwind Raod, Lahore.
Brand Name +Dosage Form + Strength Cariclor 125mg/5ml Powder for Oral Solution
Composition After reconstitution each 5ml contain:
Pharmacological Group First-generation cephalosporins
Type of Form Form 5
Pack size & Demanded Price 60ml, 90ml, 120; As per SRO
Approval status of product in Distaclor 125mg/5ml Granule for Suspension. MHRA approved
Me-too status Eclor Oral Suspension 125mg/5ml Dry Suspension. R.#083946
GMP status The firm M/s Genix Pharma was inspected on 16.02.2018, with the
following conclusion:
"In the light of inspected areas, facilities status of equipment and
hygiene and sanitation of area and equipment, control procedures
and documentations, internal and external inspection and audit
reports safety of the workers, stability protocols and data, product
development, recalls and complaints handling & other cGMP
issues, M/s Genix Pharma Pvt. Ltd Karachi was considered at an
satisfactory level of compliance with cGMP guidelines as of today.
The management was also suggested to further strengthen stability
and analytical sections.
The firm M/s Genix Pharma has submitted inspection report of M/s
King Pharmaceutical 27, Sundar industrial Estate, Sundar Raiwind
Raod, Lahore, Pakistan dated 06.02.2018, wherein renewal of
Remarks of the Evaluator.  The firm M/s Genix Pharma has submitted list of 11 products
approved for contract manufacturing.
 The firm M/s Genix Pharma has submitted list of 17 products
applied for contract manufacturing.
 The firm M/s Genix Pharma has submitted list of 04 approved
section.
 The firm has applied for ―powder for suspension‖. However,
the firm has mentioned granulation process and upon
clarification, provided evidence of reference product ―granule
for suspension‖

Daneen Pharma Pvt Ltd. 27, Sundar industrial Estate, Sundar
Raiwind Raod, Lahore, Pakistan
Brand Name +Dosage Form + Strength Cariclor 250mg/5ml Powder for Oral Solution
Composition After reconstitution each 5ml contain:
Type of Form Form 5
Pack size & Demanded Price 60ml, 90ml, 120; As per SRO
Approval status of product in Distaclor 250mg/5ml granule for Suspension. MHRA approved
Me-too status Eclor Oral Suspension 250mg/5ml Dry Suspension. Reg. No.
83945
section.
 The firm has applied for ―powder for suspension‖. However,
the firm has mentioned granulation process and upon
clarification, provided evidence of reference product
―granule for suspension‖.
Brand Name +Dosage Form + Strength Cariclor 500mg Capsule
Type of Form Form 5
Reference Regulatory Authorities. 500mg of Cefaclor). Approved by MHRA
Me-too status Deduclol 500mg Capsule. Reg. No. 80639
section.
Brand Name +Dosage Form + Strength Cariclor 250mg Capsule
Type of Form Form 5
Reference Regulatory Authorities. 250mg of Cefaclor). Approved by MHRA
Me-too status Deduclol 250mg Capsule. Reg. No. 80640
section.
Brand Name +Dosage Form + Strength Keprex 250mg Powder for Injection
Cefotaxime Sodium Eq. to Cefotaxime…250mg
Pharmacological Group Third-generation cephalosporins
Type of Form Form 5
Approval status of product in CEFOTAXIMA NORMON 250 mg POWDER AND SOLVENT
Reference Regulatory Authorities. FOR SOLUTION INJECTABLE IV EFG. CIMA approved
Me-too status Varxiame 250mg IM/IV Injection. Reg. No. 49270
section.
Applicant Karachi, 75190, Pakistan. Contract manufacturing by: M/s
Brand Name +Dosage Form + Strength Keprex 1g Powder for Injection
Cefotaxime Sodium Eq. to Cefotaxime…1g
Type of Form Form 5
Approval status of product in CEFOTAXIME INJECTION cefotaxime 1g (as sodium) powder
Reference Regulatory Authorities. for injection IV. TGA approved
section.
Brand Name +Dosage Form + Strength Keprex 500mg Powder for Injection
Cefotaxime Sodium Eq. to Cefotaxime…500mg
Type of Form Form 5
Approval status of product in Cefotaxime 500 mg powder for solution for injection. MHRA
section.
Brand Name +Dosage Form + Strength Xytol 2g Powder for Injection
Cefoperazone Sodium Eq. to Cefoperazone…1g
Sulbactam Sodium Eq. to Sulbactam…1g
Pharmacological Group Third generation cephalosporins and beta-lactamase inhibitors
Type of Form Form 5
Approval status of product in Approved in 03 European countries, i.e., Czech Republic, Poland
Reference Regulatory Authorities. and Slovakia
Me-too status Ectafin Injection 2gm IV by Hi-Medic Pharmaceuticals (Pvt)
Ltd. Reg. No. 80027
section.
Brand Name +Dosage Form + Strength Xytol 1g Powder for Injection
Cefoperazone Sodium Eq. to Cefoperazone…500mg
Sulbactam Sodium Eq. to Sulbactam…500mg
Type of Form Form 5
Approval status of product in Sulperazon Injection. PMDA Approved
Ltd. Reg. No. 80028
section..
Brand Name +Dosage Form + Strength Aleeva 500mg Powder for Injection
Cefepime as HCl…500mg
Type of Form Form 5
Approval status of product in MAXIPIME (cefepime hydrochloride) for injection, for
Reference Regulatory Authorities. intravenous or intramuscular use. USFDA Approved
Me-too status Cefevial Injection 500 mg IV Reg. No. 80029
section.
Brand Name +Dosage Form + Strength Aleeva 1g Powder for Injection
Cefepime as HCl…1g
Type of Form Form 5
Approval status of product in MAXIPIME (cefepime hydrochloride) for injection, for
Reference Regulatory Authorities. intravenous or intramuscular use. USFDA Approved
Me-too status Cefevial Injection 1g IV Reg. No. 80030
section.
1340. Name and address of manufacturer / M/s Wellness Pharmaceuticals Pvt Ltd. Plot No 33, Sundar
Brand Name +Dosage Form + Strength Myosone Tablet 50mg
Eperisone hydrochloride…50mg
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form 5
Approval status of product in Expose 50mg film coated tablet. AIFA approved
Me-too status Soma 50 mg Tablets film-coated. Reg. No. 78470
recommendations:
Based on the evaluation of the firm and findings of the inspection,
the firm was found to be operating at satisfactory level of GMP
compliant at the time of inspection. However, firm has received
approval for changes in layout plan vide letter no F.1-51/2004-Lic
dated 16-08-2018 whereby after revision three sections were
approved in layout. At the time of inspection, it was noted that
some changes in production are had been done as per approved
layout. Some changes were yet to be done. Firm was advised to
inform licensing Division Drap, Islamabad upon completion of
the proposed changes for further processing.
Remarks of the Evaluator.  The firm has provided facility of water processing without
specifications.
 The firm has changed its name to ―Horizon Healthcare (Pvt.)
Ltd Plot No. 33 Sundar Industrial Estate, Lahore and
submitted Rs. 20000/- fee dated 31.01.2019.
Brand Name +Dosage Form + Strength Coxlab Tablet 60mg
Etoricoxib…….60mg
Type of Form Form 5
Approval status of product in ARCOXIA etoricoxib 60mg film-coated tablet. TGA approved
Me-too status Gencox 60mg Tablets film-coated. Reg. No. 78839
Remarks of the Evaluator.  The firm has changed its name to ―Horizon Healthcare (Pvt.)
Brand Name +Dosage Form + Strength MBC 135mg Tablets
Mebeverine HCl…135mg
Type of Form Form 5
Approval status of product in COLESE mebeverine hydrochloride 135mg tablet film-coated.
Me-too status Mebofac Tablets 135mg film-coated. Reg. No. 74267
Brand Name +Dosage Form + Strength Flovas 4mg Tablet
Pitavstatin Calcium eq. to Pitavastatin…4mg
Type of Form Form 5
Finished Product Specification JP (with label claim: Pitavastatin Calcium Tablets contain not less
than 95.0% and not more than 105.0% of the labeled
amount of pitavastatin calcium)
Approval status of product in LIVALO (pitavastatin) Tablet, Film Coated for Oral use. USFDA
Me-too status Astin 4mg Tablet. Reg. No. 70449
Remarks of the Evaluator. The firm has changed its name to ―Horizon Healthcare (Pvt.) Ltd
Plot No. 33 Sundar Industrial Estate, Lahore and submitted
Rs.20,000/- fee dated 31.01.2019.
Brand Name +Dosage Form + Strength Ranx 500mg Tablet
Composition Each film-coated extended release tablet contains:
Ranolazine…500mg
Type of Form Form 5
Approval status of product in RANEXA® (ranolazine) 500mg extended-release tablets, film-
Reference Regulatory Authorities. coated. USFDA approved
Me-too status Rangizin XR Tablet. Reg. No. 76770
Remarks of the Evaluator.  The firm revised the formulation from film-coated to film
coated, extended release tablet (in line with the reference
product) along with submission of Rs. 5000/- fee.
Brand Name +Dosage Form + Strength Ranx 1000mg Tablet
Ranolazine…1000mg
Type of Form Form 5
Finished Product Specification ????
Approval status of product in RANEXA® (ranolazine) 1000mg extended-release tablets, film-
Reference Regulatory Authorities. coated. USFDA approved
Me-too status Ranzol-XR 1000mg Tablet. Reg. No. 61010
Remarks of the Evaluator.  The firm revised the formulation from film-coated to film
coated, extended release tablet (in line with the reference
product) along with submission of Rs. 5000/- fee.
 Decision: Deferred for clarification of finished product specifications.
Brand Name +Dosage Form + Strength Nicoran 20mg Tablet
Nicorandil…20mg
Type of Form Form 5
Approval status of product in IKOREL Nicorandil 20mg tablet un-coated. TGA approved
Me-too status Nicogina 20mg Tablet. Reg. No. 67050
Remarks of the Evaluator.  The firm revised the label claim to un-coated tablet with
submission of Rs. 5000/- fee.
 Blistering and packing steps are missing.
 Decision: Deferred for submission of complete manufacturing outlines.
Brand Name +Dosage Form + Strength Nicoran 10mg Tablet
Nicorandil…10mg
Type of Form Form 5
Approval status of product in IKOREL Nicorandil 10mg tablet un-coated. TGA approved
Me-too status Nicogina 10mg Tablet. Reg. No. 67049
Remarks of the Evaluator.  The firm revised the label claim to un-coated tablet with
 Undertaking at the end of revised form is missing.
Brand Name +Dosage Form + Strength Diltcontin 90mg Tablet
Composition Each film-coated, extended release tablet contains:
Diltiazem HCl…90mg
Type of Form Form 5
Finished Product Specification Available in USP as extended release
Approval status of product in CARDIZEM® 90mg tablet un-coated. USFDA approved
Remarks of the Evaluator.  The firm revised the label claim to exztended release tablet
Decision: Deferred for Submission of complete manufacturing outlines.
Brand Name +Dosage Form + Strength Diltcontin 120mg Tablet
Composition Each film-coated, extended release tablet contains:
Diltiazem HCl…120mg
Type of Form Form 5
Finished Product Specification Available in USP as extended release
Approval status of product in CARDIZEM® 120mg tablet un-coated. USFDA approved
Remarks of the Evaluator.  The firm revised the label claim to exztended release tablet
Brand Name +Dosage Form + Strength Liptin-M 50/500mg Tablet
Sitagliptin as phophpahte monohydrate…50mg
Metformin HCl…500mg
Type of Form Form 5
Remarks of the Evaluator.  The firm revised Sitagliptin to Sitagliptin
as phophpahte monohydrate (Form 5, master Formula, weight
adjustment as per slat factor) in line with the reference product
along with submission Rs. 5000/- fee.
 Decision: Deferred for Submission of complete manufacturing outlines.
Brand Name +Dosage Form + Strength Liptin-M 50/1000mg Tablet
Sitagliptin…50mg
Metformin HCl…1000mg
Type of Form Form 5
Remarks of the Evaluator.  The firm revised Sitagliptin to Sitagliptin as phophpahte
monohydrate (Form 5, master Formula, weight adjustment as
per slat factor) in line with the reference product along with
submission Rs. 5000/- fee.
 Decision: Deferred for Submission of complete manufacturing outlines.
Brand Name +Dosage Form + Strength Diltcontin 90mg Capsule
Diltiazem HCl (as sustained release pellets)…90mg
PKR 5,000/-: 29.04.2019
Type of Form Form 5
Approval status of product in Angitil SR 90mg MR capsules. MHRA approved
Me-too status TIAZEM SR 90MG CAP. Reg No. 10863
Remarks of the Evaluator.  The firm has revised formulation in line with the reference
product without submission of Rs. 5000/- fee.
 The pellets have been tested /analysed with unknown
specifications.
 The long term stability of pellets has been conducted at 25±2
C, 65±5 RH.
 Differential fee for imported pellets is required.
 GMP certificate of source of pellets is required.
 The reference for specifications of pellets.
 The long term stability of pellets shall be conducted in zone IV-A.
Brand Name +Dosage Form + Strength Diltcontin 180mg Capsule
Diltiazem HCl (as sustained release pellets)…180mg
Type of Form Form 5
Approval status of product in Angitil SR 180mg MR capsules. MHRA approved
Remarks of the Evaluator.  The firm has revised formulation in line with the reference
product without submission of Rs. 5000/- fee.
Ltd Plot No.33 Sundar Industrial Estate, Lahore and submitted
Rs.20,000/- fee dated 31.01.2019.
 The pellets have been tested /analysed with unknown
specifications.
C, 65±5 RH.
 The reference for specifications of pellets.
Brand Name +Dosage Form + Strength Clowin 50mg tablet
Clomiphene citrate…50mg
Type of Form Form 5
Approval status of product in GENRX CLOMIPHENE clomifene citrate 50mg tablet, un-
Reference Regulatory Authorities. coated. TGA approved
Me-too status OVA-MIT TABLETS. Reg. No. 20404
Remarks of the Evaluator.  Blistering and packing steps are missing in the manufacturing
outlines.
Brand Name +Dosage Form + Strength Clowin 50mg capsule
Clomiphene citrate…50mg
Type of Form Form 5
Me-too status PROLIFEN CAP. Reg. No. 10250
Remarks of the Evaluator.  Blistering and packing steps are missing in the manufacturing
outlines.
 Submission of complete manufacturing outlines.
authority as defined in 275th meeting of the Registration Board
Brand Name +Dosage Form + Strength Prostem 400mcg capsule
Tamsulosin HCl (modified release pellets)…400mcg
Pharmacological Group Drugs used in benign prostatic hypertrophy
Type of Form Form 5
Approval status of product in FLOMAX® (tamsulosin hydrochloride, USP) Capsules, for oral
Me-too status Tamsolin 0.4mg Capsule. Reg. No. 50392
 Blistering and packing steps are missing in the manufacturing
outlines.
 The firm has revised the salt form of API and formulation in
line with the reference product with submission of Rs. 5000/-
fee.
 The pellets have been tested with in-house specifications.
C, 65±5 RH.
 Submission of complete manufacturing outline.
Brand Name +Dosage Form + Strength Jmslim 120mg capsule
Orlistat…120mg
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form 5
Approval status of product in Beacita 120mg Capsules, hard. MHRA approved
Me-too status Xenical Capsule. Reg. No. 42142
Remarks of the Evaluator.  Diltiazem HCl has been mentioned in the
filling step of manufacturing outlines
 Blistering and packing steps are missing
in the manufacturing outlines.

1358. Name and address of manufacturer / Jupiter Pharma Plot No. 25, Street # S-6, National Industrial Zone
Applicant (RCCI) Rawat Rawalpindi
Brand Name +Dosage Form + Strength Clarip Tablet 500mg
Clarithromycin…..500mg
Type of Form Form 5
Approval status of product in Clarithromycin 500 mg Film-coated Tablets. MHRA approved
Me-too status Clarital 500mg Tablet. Reg. No. 85500
conclusion:
Keeping in view the above stated observations during inspection,
areas visited, documents reviewed it is concluded that M/s Jupiter
Pharma Rawat is operating at fair level of cGMP compliance as of
today.
Remarks of the Evaluator.  The firm submitted updated Form 5. First page of Form 5 is
missing.
 Decision: Deferred for submission of First page of Form 5.
Brand Name +Dosage Form + Strength Clarip Tablet 250mg
Type of Form Form 5
Approval status of product in Clarithromycin 250 mg Film-coated Tablets. MHRA approved
Me-too status Clarital 250mg Tablet. Reg. No. 85501
missing.
Brand Name +Dosage Form + Strength J-Artan Tablet 25mg
Losartan Potassium…..25mg
Type of Form Form 5
Approval status of product in Cozaar® 25 mg film-coated tablets. MHRA approved
Me-too status Lotass 25mg Tablet. Reg. No. 66802
Remarks of the Evaluator. Firm submitted updated Form 5. First page of Form 5 is missing.
Brand Name +Dosage Form + Strength J-Artan Tablet 50mg
Losartan Potassium…..50mg
Type of Form Form 5
Approval status of product in Cozaar® 50 mg film-coated tablets. MHRA approved
Me-too status Lotass 50mg Tablet. Reg. No. 66803
Remarks of the Evaluator. Firm submitted updated Form 5. First page of Form 5 is missing.

Brand Name +Dosage Form + Strength Clarip Dry Suspension 250mg/5ml
Type of Form Form 5
Approval status of product in Clarithromycin 250mg/5ml granules for oral suspension. MHRA
Me-too status KETEK 250 mg/5ml Oral Suspension. Reg. No. 84173 (does not
depict granules)
missing.
1363. Name and address of manufacturer / Saibins Pharmaceuticals Plot # 316 Industrial Triangle Kahuta
Brand Name +Dosage Form + Strength Truvan-D 80+12.5mg Tablets
Hydrochlorthiazide…..12.5mg
Type of Form Form 5
Approval status of product in Co-Diovan 80mg/12.5mg film-coated tablets by Novartis Farma
Reference Regulatory Authorities. S.p.A., Via Provinciale Schito. Approved by MHRA
Me-too status Valzar Plus 80/12.5 Tablets by Remington Pharmaceuticals (Pvt)
Ltd,. Reg. No. 50901
GMP status The firm has been granted GMP inspection on the basis of
inspection dated 24.12.2018.
Brand Name +Dosage Form + Strength Truvan-D 160+25mg Tablets
Valsartan USP……….160mg
Hydrochlorthiazide BP…..25mg
Type of Form Form 5
Approval status of product in Co-Diovan 160mg/25mg film-coated tablets by Novartis Farma
Reference Regulatory Authorities. S.p.A., Via Provinciale Schito. Approved by MHRA
Me-too status Valzar Plus 160/25 Tablets by Remington Pharmaceuticals (Pvt)
Ltd. Reg. No. 50900

Brand Name +Dosage Form + Strength Truvan-D 160+12.5mg Tablets
Valsartan USP……….160mg
Hydrochlorthiazide BP…..12.5mg
Type of Form Form 5
Approval status of product in Co-Diovan 160mg/12.5mg tablets by Novartis Farma S.p.A., Via
Reference Regulatory Authorities. Provinciale Schito. Approved by MHRA
Me-too status Velker Plus Tablet by High-Q Pharma Karachi.. Reg. No. 76210
Brand Name +Dosage Form + Strength Saipin F 6/25 mg Capsules
Olanzapine……….6mg
Fluoxetine as HCl…..25mg
Pharmacological Group Antipsychotics and selective serotonin reuptake inhibitors
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer‘s specs (Available in USP)
Approval status of product in SYMBYAX (olanzapine and fluoxetine) capsules by Eli Lilly
Reference Regulatory Authorities. and Company. Approved by US-FDA
Me-too status Co-Depricap 6/25 Capsule by NabiQasim Karachi. Reg. No. 76135
Remarks of the Evaluator.  The firm revised Fluoxetine to Fluoxetine (as
hydrochloride) without submission of any fee.
 Decision: approved with USP specifications.
Brand Name +Dosage Form + Strength Saipin F 6/50 mg Capsules
Type of Form Form 5
Me-too status Not confirmed
Remarks of the Evaluator. The firm revised Fluoxetine to Fluoxetine (as hydrochloride)
without submission of any fee.
 Decision: Deferred for submission of fee for revision of formulation
Brand Name +Dosage Form + Strength Saipin F 12/50mg Capsules
Type of Form Form 5
Pack size & Demanded Price 2x7; As per SRO
Approval status of product in SYMBYAX (olanzapine and fluoxetine) capsules by Eli Lilly and
Reference Regulatory Authorities. Company. Approved by US-FDA
Type of Form Form 5
Me-too status Dipof 3/25 mg capsule by Global Pharmaceuticals. Reg. No. 77899
Type of Form Form 5
Me-too status Amprexa-F 12/25mg Capsule by Amarant Pharma (R.#076751)
Brand Name +Dosage Form + Strength Truvan 160mg Tablets
Valsartan……..160mg
Type of Form Form 5
Approval status of product in Cuenca 160 mg film-coated tablets by Laboratorios Liconsa, S.A.
Reference Regulatory Authorities. Approved by MHRA
Me-too status Velker Tablet by High-Q Pharma Karachi. Reg. No. 76209
Brand Name +Dosage Form + Strength Truvan 80mg Tablets
Valsartan……..80mg
Type of Form Form 5
Approval status of product in Cuenca 00 mg film-coated tablets by Laboratorios Liconsa, S.A.
Reference Regulatory Authorities. Approved by MHRA
Me-too status Velker 80 mg Tablet by High-Q Pharma Karachi. Reg. No. 76202
Brand Name +Dosage Form + Strength Norvan HCT 5+80+12.5mg Tablets
Amlodipine as besilate (BP)…..5mg
Valsartan (USP)……..80mg
Hydrochlorthiazide (BP)….12.5mg
Type of Form Form 5
Approval status of product in Not confirmed
 Proof of approval of me-too product with same dosage form, same strength and same pack size by
DRAP.
authority as defined in 275th meeting of the Registration Board.
Brand Name +Dosage Form + Strength Norvan HCT 5+160+25mg Tablets
Hydrochlorthiazide (BP)….25mg
Type of Form Form 5
Me-too status Exforge HCT 5/160/25MG film coated tablets by Novatris Pharma.
Reg. No. 69549
Type of Form Form 5
Brand Name +Dosage Form + Strength Norvan HCT 10+160+25mg Tablets
Hydrochlorthiazide (BP)….25mg
Type of Form Form 5
Remarks of the Evaluator. Correction of quantity of Hydrochlorthiazide in Master Formula is
required.
Decision: Deferred for correction of quantity of Hydrochlorthiazide in Master Formula.
PKR 20,000/-: 29.12.2017
Type of Form Form 5
Brand Name +Dosage Form + Strength Spasnil Tablets
Phloroglucinol…..80mg
trimethylphloroglucinol ……..80mg
Type of Form Form 5
Approval status of product in PHLOROGLUCINOL / TRIMETHYLPHLOROGLUCINOL
Reference Regulatory Authorities. ACINO 62.233 mg / 80 mg, coated tablet by ACINO France SAS.
Approved by ANSM
Me-too status Despasm Tablet by Irza Pharmaceuticals. Reg. No. 85210
Remarks of the Evaluator.  International availability is the form of sugar-coated tablet. The
firm revised the formulation to sugar-coated tablet without
submission of prescribed fee and correction of label. Morever,
sugar/sucrose has not been mentioned in the composition of
coating
 The API ‗Phloroglucinol‘ is the form of ‗Phloroglucinol hydrate‘.
Necessary correction is required.
 Submission of fee for revision of formulation.
 Correction of label and composition of coating
 Correction of‗Phloroglucinol‘ to ‗Phloroglucinol hydrate‘.
Brand Name +Dosage Form + Strength Trupride 1mg Tablet
Cinitapride hydrogen tartarate eq. to Cinitapride …..1mg
Pharmacological Group Drugs for functional gastrointestinal disorders, Propulsives
Type of Form Form 5
Approval status of product in Blaston 1 mg Tablets by LACER, SA. Approved by Spanish
Reference Regulatory Authorities. Agency of Medicines and Health Products
Me-too status Cint 1mg Tablet by High-Q Pharmaceuticals. Reg. No. 73888
Remarks of the Evaluator.  Mention correct quantity of API in Master Formula
after adjustment of salt factor.
 Decision: Deferred for correction of quantity of API in Master Formula.
Brand Name +Dosage Form + Strength Bera 20mcg Tablet
Beraprost as sodium …..20mcg
Type of Form Form 5
Me-too status Benprost 20mcg tablet by Nabiqasim Karachi. Reg. No. 61237
Brand Name +Dosage Form + Strength Impat 100mg Tablet
Lacosamide …..100mg
Type of Form Form 5
Finished Product Specification The firm did not mentioned in reference
Approval status of product in Lacosamide Aspire 100 mg film-coated tablets by Aspire Pharma
Reference Regulatory Authorities. Limited. MHRA Approved
Me-too status Lalap 100mg Tablet by Genix Pharma (Pvt.) Ltd. Reg. No. 70471
Brand Name +Dosage Form + Strength Impat 50mg Tablet
Lacosamide …..50mg
Type of Form Form 5
Finished Product Specification The firm did not mentioned in reference
Approval status of product in Lacosamide Aspire 50 mg film-coated tablets by Aspire Pharma
Reference Regulatory Authorities. Limited. MHRA Approved
Me-too status Lalap 50mg Tablet by Genix Pharma (Pvt.) Ltd. Reg. No. 70470
Brand Name +Dosage Form + Strength TIO-F Capsule
Tiotropium (as bromide monohydrate)…..18mcg
Formoterol fumarate dihydrate……….12mcg
Pharmacological Group Drugs for obstructive airway diseases
Type of Form Form 5
Finished Product Specification The firm has claimed Innovator‘s specifications.
Me-too status Tiovair-F Rotacaps by Highnoon Laboratories. Reg. No. 054314
Remarks of the Evaluator.  Proof of International availability of same dosage form with
same strength in reference regulatory authority as defined in
275th meeting of the Registration Board is required.
 Provision of manufacturing facility for steroid-based rotacap is
required.
 Decision: deferred for the following:
regulatory authority as defined in 275th meeting of the Registration Board.
 Provision of manufacturing facility for steroid-based rotacap.
Brand Name +Dosage Form + Strength Bufor Capsule
Budenoside…..200mcg
Formoterol fumarate as dihydrate……….6mcg
Pharmacological Group Drugs for obstructive airway diseases
Type of Form Form 5
Pack size & Demanded Price 3×10‘s: As per SRO
Remarks of the Evaluator.  Provision of manufacturing facility for steroid-based
rotacap is required.
 Proof of International availability of same dosage form
with same strength in reference regulatory authority as defined in
275th meeting of the Registration Board is required.
 The registration Board in its 283rd meeting approved
Wilsonide Plus 200mcg+6mcg Rotacaps of M/s Wilson‘s
Pharmaceuticals on the basis of Symbicort 200/6 Turbohaler,
Inhalation Powder by M/s AstraZeneca (MHRA Approved) with
the following decision ―Registration Board deliberated that
instant product is in unit dose preparation / rotacap having same
dose per actuation as in multidose product. Thus Registration
Board approved the product.”
regulatory authority as defined in 275th meeting of the Registration Board.
 Provision of manufacturing facility for steroid-based rotacap.
Brand Name +Dosage Form + Strength Etor Tablet 60mg
Etoricoxib…..60mg
Pharmacological Group Anti-inflammatory and antirheumatic products, non-steroids
Type of Form Form 5
Approval status of product in ARCOXIA 60 mg film-coated tablets by Merck Sharp & Dohme
Reference Regulatory Authorities. BV. ANSM approved
Me-too status Eto 60 mg Tablet by Linta Pharmaceuticals. Reg No. 78176
Brand Name +Dosage Form + Strength Ronic Tablet 150mg
Ibandronate sodium monohydrate eq. to ibnadronic acid …..150mg
Pharmacological Group Drugs affecting bone structure and mineralization
Type of Form Form 5
Approval status of product in BONIVA (ibandronate sodium) film-coated Tablets by Hoffmann
Reference Regulatory Authorities. LA Roche. US-FDA approved
Me-too status Ibadron 150mg Tablet by S.J.&G.FazulEllahie(Pvt) Ltd. Reg No.
58637
Remarks of the Evaluator. The firm revised the salt form ibandronate sodium as monohydrate
eq. to ibnadronic acid 150mg without submission of any fee.
 Decision: Deferred for submission of fee for revision of formulation.
Brand Name +Dosage Form + Strength Bosent Tablet 62.5mg
Bosentan as monohydrate…..62.5mg
Pharmacological Group Antihypertensives for pulmonary arterial hypertension
Type of Form Form 5
Approval status of product in TRACLEER® (bosentan) film-coated tablets, for oral use by
Reference Regulatory Authorities. Actelion Pharms Ltd. US-FDA approved
Me-too status Bosecard 62.5mg tablet by Zafa Pharma Karachi. Reg No. 81464
Brand Name +Dosage Form + Strength Bosent Tablet 125mg
Bosentan as monohydrate…..125mg
Pharmacological Group Antihypertensives for pulmonary arterial hypertension
Type of Form Form 5
Approval status of product in TRACLEER® (bosentan) film-coated tablets, for oral use by
Reference Regulatory Authorities. Actelion Pharms Ltd. US-FDA approved
Me-too status Bozpah 125mg Tablet by Nabiqasim Karachi. Reg No. 81521
Brand Name +Dosage Form + Strength Dechol Tablet 40mg
Atorvastatin (as calcium trihydrate)…..40mg
Type of Form Form 5
Approval status of product in ACH-ATORVASTATIN CALCIUM (film-coated) by Accord
Reference Regulatory Authorities. Healthcare Inc. Health Canada approved
Me-too status Fatilor 40mg Tablet by Lisko Pakistan Ltd. Reg No. 58163 (does
not depict film-coating)
Atorvastatin (as Atorvastatin calcium trihydrate)…..20mg
Type of Form Form 5
Me-too status Torvia 20mg Tablet by Pakistan Pharmaceutical Products. Reg No.
81161
Atorvastatin (as Atorvastatin calcium trihydrate)…..10mg
Type of Form Form 5
Me-too status Torvia 10mg Tablet by Pakistan Pharmaceutical Products. Reg.
No. 81162
Brand Name +Dosage Form + Strength Linezolid Tablet 600mg
Linezolid…..600mg
Pharmacological Group Antibacterials for systemic use
Type of Form Form 5
Approval status of product in ZYVOX® (linezolid) 600mg tablets (film-coated) for oral use by
Reference Regulatory Authorities. Pharmacia and Upjohn. US-FDA approved
Me-too status Ozlin 600 mg Tablet by Linta Pharmaceuticals. Reg No. 78179
Brand Name +Dosage Form + Strength Linezolid Tablet 400mg
Linezolid…..400mg
Pharmacological Group Antibacterials for systemic use
Type of Form Form 5
Approval status of product in ZYVOX® (linezolid) tablets (film-coated) for oral use by
Reference Regulatory Authorities. Pharmacia and Upjohn. not discontinued or withdrawn by US-FDA
for safety or efficacy reasons
Me-too status Enliv 400mg Tablet by PharmEvo (Pvt.) Ltd. Reg No. 58096 (does
not depict coating)
Brand Name +Dosage Form + Strength Bystol Tablet 10mg
Nebivolol HCl eq. to Nebivolol…..10mg
Type of Form Form 5
Approval status of product in BYSTOLIC® (nebivolol 10mg) tablets, for oral use by Allergan
Reference Regulatory Authorities. Sales LLC. US-FDA approved
Me-too status Bynevol 10mg Tablet by Atco Lab Karachi. Reg No. 81562

Brand Name +Dosage Form + Strength Bystol Tablet 5mg
Nebivolol HCl eq. to Nebivolol…..5mg
Type of Form Form 5
Approval status of product in BYSTOLIC® (nebivolol 5mg) tablets, for oral use by Allergan
Me-too status Bynevol 5mg Tablet by Atco Lab Karachi. Reg No. 81099
Brand Name +Dosage Form + Strength Bystol Tablet 2.5mg
Nebivolol HCl eq. to Nebivolol…..2.5mg
Type of Form Form 5
Approval status of product in BYSTOLIC® (nebivolol 2.5mg) tablets, for oral use by Allergan
Me-too status Bynevol 2.5mg Tablet by Atco Lab Karachi. Reg No. 81561
Brand Name +Dosage Form + Strength Vidin tablet 50mg+1000mg
Vildagliptin…..50mg
Metformin hydrochloride BP…..1000mg
Type of Form Form 5
Approval status of product in GALVUMET 50/1000 vildagliptin 50 mg/metformin
Reference Regulatory Authorities. hydrochloride 1000 mg film coated tablet by Novartis
Pharmaceuticals Australia Pty Ltd. TGA approved
Me-too status Valiant-M Tablets by Ferozsons Labs., Nowshehra. Reg No. 77485
Remarks of the Evaluator. The approved shelf-life of the product in 18 months in TGA
Australia
 Decision: Approved with 18 months of shelf life
Brand Name +Dosage Form + Strength Vidin tablet 50mg+500mg
Vildagliptin…..50mg
Metformin hydrochloride BP…..500mg
Type of Form Form 5
Approval status of product in GALVUMET 50/500 vildagliptin 50 mg/metformin hydrochloride
Reference Regulatory Authorities. 500 mg film coated tablet by Novartis Pharmaceuticals Australia
Pty Ltd. TGA approved
Me-too status Galmet 50mg/500mg Tablet by Vision Pharma. Reg No. 81905
Remarks of the Evaluator. The approved shelf-life of the product in 18 months in TGA
Australia
 Decision: Approved with 18 months of shelf life
Brand Name +Dosage Form + Strength Platax tablet 75mg
Clopedogrel as bisulphate……..75mg
Type of Form Form 5
Approval status of product in NOUMED CLOPIDOGREL clopidogrel (as hydrogen sulfate) 75
Reference Regulatory Authorities. mg film coated tablet blister by Blooming Health Pty Ltd. TGA
approved
Me-too status Disclot Tablets. Reg No. 33906
Brand Name +Dosage Form + Strength Platax Plus tablet 75mg+81mg
Composition Each film-coated bilayer tablet contains:
Clopidogrel……..75mg
acetylsalicylic acid……….81mg
Type of Form Form 5
Approval status of product in DUOPLAVIN 75 mg / 75 mg film-coated tablets. ANSM approved
Remarks of the Evaluator.  The firm revised acetylsalicylic acid …..81mg to acetylsalicylic
acid…..75mg.
 In Form 5, the firm has claimed Clopedogrel (75mg) and
acetylsalicylic acid (81mg) while in Master Formula they have
label claim is Clopidogrel as bisulphate (75mg) and
acetylsalicylic acid (75mg).
 The product in international reference country is film-coated
tablet. Justification was asked form the firm for manufacturing of
bilayer tablet is required. The firm simply replied that they will
manufacture film-coated tablet. They did not revised the
composition and manufacturing outlines etc.
 The firm did not mention granulation process. However, in 287 th
meeting similar product was deferred for deliberation with
remarks of evaluator ―Internationally available as film coated
tablet prepared by mixing granules of clopidogrel (prepared by
wet granulation) and aspirin (prepared by dry granulation)‖.
 Revision of formaulation and all the related documetns in line with the reference pro duct along with
submission of applicable fee.
Brand Name +Dosage Form + Strength Norbin tablet 5mg
Amlodipine besilate Ph. Eur. eq. to amlodipine…….5mg
Diary No. Date of R& I & fee Dy No. 26912: 29.12.2017 KR 20,000/-: 29.12.2017
Pharmacological Group Selective calcium channel blockers with mainly vascular effects
Type of Form Form 5
Approval status of product in NORVASC amlodipine 5mg (as besilate) tablet by Pfizer Australia
Reference Regulatory Authorities. Pty Ltd. TGA approved
Me-too status Sofvasc 5mg Tablets by Wilson‘s Pharmaceuticals, Islamabad. Reg
No. 20182
Brand Name +Dosage Form + Strength Norbin tablet 10mg
Amlodipine besilate Ph. Eur. eq. to amlodipine…….10mg
Pharmacological Group Selective calcium channel blockers with mainly vascular effects
Type of Form Form 5
Approval status of product in NORVASC amlodipine 10mg (as besilate) tablet by Pfizer
Reference Regulatory Authorities. Australia Pty Ltd. TGA approved
Me-too status Sofvasc 10mg Tablets by Wilson‘s Pharmaceuticals, Islamabad.
Reg No. 20183
Brand Name +Dosage Form + Strength Louric tablet 80mg
Febuxostat…….80mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form 5
Approval status of product in ULORIC (febuxostat) 80mg tablet (coated) for oral use by Takeda
Reference Regulatory Authorities. Pharms USA. US-FDA approved
Me-too status Adenuric 80mg Tablet by S.J & G Fazul Ellahie (PVt) Ltd,
Karachi. Reg No. 67034
 Decision: Approved with change of brand name
Brand Name +Dosage Form + Strength Louric tablet 40mg
Febuxostat…….40mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form 5
Approval status of product in ULORIC (febuxostat) 40mg tablet (coated) for oral use by Takeda
Reference Regulatory Authorities. Pharms USA. US-FDA approved
Me-too status Adenuric 40mg Tablet by S.J & G Fazul Ellahie (PVt) Ltd,
Karachi. Reg No. 67033
1405. Name and address of manufacturer / Caraway Pharmaceuticals Plot No. 12 Street # N-3 National
Applicant Industrial Zone (RCCI) Rawat Islamabad Pakistan
Brand Name +Dosage Form + Strength Famcare Tablet 2.5mg
Letrozole……..2.5mg
Pharmacological Group Aromatase Inhibitors
Type of Form Form 5
Approval status of product in Letrozole 2.5 mg, film-coated tablets. MHRA approved
Me-too status Letzole Tablets 2.5mg. Reg. No. 75805
Remarks of the Evaluator.  The firm had mentione film-coated tablet and mentioned
compositions and step of coating. However, in Form 5, it was
―each tablet contain‖. The firm corrected the label claim to
film-coated tablet.

B. DEFERRED CASES:
1406. Name and address of manufacturer /M/s Fozan Pharmaceutical. 36-A, Industrial Estate, Hayatabad,
Applicant Peshsawar. Contract Manufacturing by: M/s Welwrd
Pharmaceuticals, Plot # 3, Block_A, PhaseI-II, Hattar Industrial
Estate, Hattar
Brand Name +Dosage Form + Strength KORS Injection 2g
Cefoperazone as sodium…1g
Sulbactam as sodium…..1g
Type of Form Form 5
Approval status of product in Approved in 03 European countries, i.e., Czech Republic,
Reference Regulatory Authorities. Poland and Slovakia
Ltd. Reg. No. 80027
GMP status Inspection of M/s Wellwrd Pharma was conducted on
12.11.2018, wherein the following sections of the firm were
considered to be operating at satisfactory level of GMP.
i) Tablet Section (General/antibiotics)
ii) Liquid injectable section (General/antibiotics)
iii) Dry injectable section (General/antibiotics)
iv) Dry powder injectable (cephalosporins)
While the remaining sections viz Capsule general, dry powder
suspension general and Sachet sections were observed with
certain shortcomings that need to be rectified.
Remarks of the Evaluator.  The firm has submitted list of six (06) approved products for
contract manufacturing.
 The firm has submitted list of eleven (11) products applied for
contract manufacturing.
 Latest GMP inspection report of manufacturer, M/s Fozan
Pharmaceutical shows that the firm has seven (07) approved section.
Previous decision  The Board in its 287 th meeting deferred the case for correction of
label claim.
 The Board in its 288 th meeting deferred the case for revision of
Form 5.
Evaluation by PEC  The firm submitted revised Form 5.
1407. Name and address of manufacturer / Tayyab Laboratories Pvt. Ltd. Plot No. 13-A, Street N-5,
Applicant National Industrial Zone, Rawat, Islamabad, Pakistan
Brand Name +Dosage Form + Strength Asko Plus Tablet
Paracetamol USP…..500mg
Hyoscine_N-butyl bromide BP….10mg
PKR: 5,000/-; 17.12.2018
Pharmacological Group Paracetamol combination with antispasmodic/psycholeptics
Type of Form Form 5
Approval status of product in Buscopan Plus film-coated tablet. DMDI Germany approved
Me-too status Hyo-Plus Tablets. Reg. No. 64452 (film-coated)
conclusion:
Keeping in view the above facts, detailed visit of the facility,
and supporting documents provided by the company, the firm
M/s Tayyab Laboratories (Pvt) Ltd., Plot No, 13, Street No N-5
RCCI, Rawat, Rawalpindi, found complaint as of today and
advised to continue with the process of up-gradation with same
spirit.
Remarks of the Evaluator.  The firm was asked to submit updated Form 5 duly signed by the
concerned persons. The firm submitted Form 5. However,
undertaking at the end of Form 5 is still missing.
 The firm provide new name as ―Arreta Pharmaceuticals Pvt. Ltd.
Plot No. 13, Street N-5, National Industrial Zone, Rawat,
Islamabad, Pakistan
Previous decision  The registration Board in its 287 th meeting deferred the case for
submission of undertaking at the end of Form 5.
Emulation by PEC  The firm submitted updated duly signed Form 5.
 The firm has claimed innovator‘s specifications.
 The firm submitted Rs. 20,000/- dated 19.04.2019. Dy. No. 4039.
1408. Name and address of manufacturer / Rotex Pharma Pvt Ltd. Plot No. 206 & 207. Industrial Triangle,
Applicant Kahuta Road, Islamabad Pakistan
Brand Name +Dosage Form + Strength Etox CR 25mg Tablet
Composition Each enteric, film-coated, controlled release tablet contains:
Paroxetine (as HCl hemihydrate)……25mg
Diary No. Date of R& I & fee Dy No. 41547: 07.12..2018 PKR 20,000/-: 07.12..2018
Type of Form Form 5
Approval status of product in PAXILCR enteric, film-coated tablet 25mg. USFDA approved
Me-too status Panox CR Tablet 25 mg. Reg. No. 81954 (does not depict
enteric, film coating and hemihydrate form).
GMP status New section granted on the basis of inspection dated 19.09.2018
Remarks of the Evaluator.  The firm revised the formulation from controlled release tablet‖ to
―enteric, film-coated, controlled release tablet‖ without submission
of any fee.
Previous decision The Board in its 288 th meeting deferred the case for submission of
fee for revision of formulation
Fee submitted Rs. 5000/-; dated 14.02.2019
1409. Name and address of manufacturer / Rotex Pharma Pvt Ltd. Plot No. 206 & 207. Industrial Triangle,
Applicant Kahuta Road, Islamabad Pakistan
Brand Name +Dosage Form + Strength Etox CR 12.5mg Tablet
Composition Each enteric, film-coated, controlled release tablet contains:
Paroxetine (as HCl hemihydrate)……12.5mg
Diary No. Date of R& I & fee Dy No. 41554: 07.12..2018 PKR 20,000/-: 07.12..2018
Type of Form Form 5
Approval status of product in PAXILCR enteric, film-coated tablet 12.5mg. USFDA approved
Me-too status Jurox CR 12.5 Tablet. Reg. No. 81929 (does not depict
enteric, film coating and hemihydrate form).
GMP status New section granted on the basis of inspection dated 19.09.2018
Remarks of the Evaluator.  The firm revised the formulation from controlled release tablet‖ to
―enteric, film-coated, controlled release tablet‖ without submission
of any fee.
th
Previous decision The Board in its 288 th meeting deferred the case for submission of
fee for revision of formulation
Fee submitted Rs. 5000/-; dated 14.02.2019
Case No. 02: Registration applications of newly granted DML or New section (Human)
a. New DML
The CLB in its 267th meeting held on 31.12.2018 has been granted DML to the firm. The firm has applied
for 07 molecules (14 products) in the dry powder (cephalosporin) section.
Applicant Triangle, Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Rulex Powder for oral suspension 250mg/5ml
Cephalexin as monohydrate…… 250mg
Type of Form Form 5
Approval status of product in GENRX CEPHALEXIN cefalexin (as monohydrate)
Reference Regulatory Authorities. 250mg/5mL powder for suspension. TGA approved
Me-too status Pefalex Suspension 250mg. Reg. No. 80050
GMP status New DML
Brand Name +Dosage Form + Strength Rulex Powder for oral suspension 125mg/5ml
Type of Form Form 5
Approval status of product in GENRX CEPHALEXIN cefalexin (as monohydrate)
Reference Regulatory Authorities. 125mg/5mL powder for suspension. TGA approved
Me-too status Pefalex Suspension 125mg. Reg. No. 80049
GMP status New DML
Brand Name +Dosage Form + Strength Rulex Powder for oral drops 100mg/ml
Type of Form Form 5
Approval status of product in Kefex 100 mg / ml granules for oral suspension. Approved in
Reference Regulatory Authorities. Finland
KEFLEX EQ 100mg base/ml discontinued in USFDA but not
for safety or efficacy reasons.
Me-too status KEFLEX PAED, 100MG DRP. Reg. No. 1071
GMP status New DML
Remarks of the Evaluator.  Kefexin in Finland has Pharmaceutical form as ―Granules
for oral suspension: orange-yellow powder‖ and the salt
from does not depict hydrate from of API. Moreover,
there is no description for drops or dropper. The nature
and content of container are 30 and 50 ml: glass bottle
(type III glass) and polyethylene / polypropylene closure.
It is pertinent to mention that Cefaclor ―for suspension‖
and oral drop have been mentioned separate in the same
strength in AIFA, wherein the latter is supplied with
dropper. Only the following statement is present: With the
syringe for dispensing, an adapter from a separate Orion
Pharma can be attached to the bottle mouth adapter /
syringe package
 The Board in tis 271th meeting has approved Nufex
Pediatric drop 100mg/ml on the basis of KEFLEX EQ
100mg base/ml discontinued in USFDA but not for safety
or efficacy reasons, The SmPC is not available to get the
requisite information.
Brand Name +Dosage Form + Strength Micef Powder for oral suspension 200mg/5ml
Cefixime as trihydrate…… 200mg
Type of Form Form 5
Approval status of product in SUPRAX® (cefixime) for oral suspension. USFDA approved
Me-too status Elixime Dry Suspension 200mg. Reg. No. 53730
GMP status New DML
Brand Name +Dosage Form + Strength Micef Powder for oral suspension 100mg/5ml
Cefixime as trihydrate…… 100mg
Type of Form Form 5
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension. MHRA
Me-too status Elixime Dry Suspension 100mg. Reg. No. 53729
GMP status New DML
Brand Name +Dosage Form + Strength Cefrid Powder for oral suspension 250mg/5ml
Cephradine as monhydrate…… 250mg
Type of Form Form 5
Pack size & Demanded Price 30 ml; As per SRO
Me-too status Hidin Oral Suspension 250mg. Reg. No. 80036
GMP status New DML
Decision: Deferred for Proof of International availability of same dosage form with same strength
in reference regulatory authority as defined in 275th meeting of the Registratio n Board.
Brand Name +Dosage Form + Strength Cefrid Powder for oral suspension 125mg/5ml
Cephradine as monhydrate…… 125mg
Type of Form Form 5
Me-too status Hidin Oral Suspension 125mg. Reg. No. 80037
GMP status New DML
 Decision: Decision: Deferred for Proof of International availability of same dosage form with same
strength in reference regulatory authority as defined in 275th meeting of the Registration Board.
Brand Name +Dosage Form + Strength Furox Powder for oral suspension 125mg/5ml
Cefuroxime as axetil…… 125mg
Type of Form Form 5
Approval status of product in Zinnat granules for Suspension 125mg/5ml. MHRA approved
Me-too status Kefzy Suspension 125mg/5ml. Reg. No. 82756
GMP status New DML
Remarks of the Evaluator.  The reference product contains granules for oral
suspension. However, the provided master formula and
manufacturing outlines does not depict granule formation.
The firm was asked for justification/ clarification. The firm
provided another reference product, which could be verified.
 Decision: Deferred for confirmation of approval status in reference regulatory authoritis.
Brand Name +Dosage Form + Strength Furox Powder for oral suspension 250mg/5ml
Cefuroxime as axetil…… 250mg
Type of Form Form 5
Me-too status Kefzy Suspension 250mg/5ml. Reg. No. 82757
GMP status New DML
Remarks of the Evaluator. The reference product contains granules for oral suspension.
However, the provided master formula and manufacturing
outlines does not depict granule formation. The firm was
asked for justification/ clarification. The firm provided another
reference product, which could not be verified.
 Decision: Deferred for Proof of International availability of same dosage form with same strength
in reference regulatory authority as adopted in 275th meeting of the Registration Board.
Brand Name +Dosage Form + Strength Cecil Powder for oral suspension 125mg/5ml
Cefadroxil as monohydrate…… 125mg
Type of Form Form 5
Approval status of product in Biodroxil 125 mg /5 ml - Pulver zur Herstellung einer
Reference Regulatory Authorities. Suspension zum Einnehmen (Biodroxil 125 mg / 5 ml -
Powder for oral suspension). AGES approved
Me-too status Evacef Suspension 125mg. Reg. No. 11213
GMP status New DML
Brand Name +Dosage Form + Strength Cecil Powder for oral suspension 250mg/5ml
Cefadroxil as monohydrate…… 250mg
Type of Form Form 5
Approval status of product in Cefadroxil 250 mg/5 ml powder for oral suspension. USFDA
Me-too status Evacef Suspension 250mg. Reg. No. 11214
GMP status New DML
Brand Name +Dosage Form + Strength Ceficlor Powder for oral suspension 250mg/5ml
Cefaclor as monohydrate…… 250mg
Type of Form Form 5
Approval status of product in Cefaclor 250mg/5ml powder for Suspension. MHRA
83945
GMP status New DML
Brand Name +Dosage Form + Strength Ceficlor Powder for oral suspension 125mg/5ml
Type of Form Form 5
Approval status of product in Cefaclor 125mg/5ml powder for Suspension. MHRA
83946
GMP status New DML
Brand Name +Dosage Form + Strength Ceficlor Powder for oral drops 50mg/ml
Type of Form Form 5
Approval status of product in PANACEF 50 mg/ml gocce orali, sospensione. AIFA
Me-too status Cefalor Drops 50mg/ml. Reg. No. 34368
GMP status New DML
Remarks of the Evaluator.  The reference product is oral drops, suspension with
direction for reconstitution.
The firm has been granted DML on the basis of inspection 13.11.2018 & 17.12.2018. The firm has applied
for 10 molecules (21 products) in the capsule section.
1424. Name and address of manufacturer / Invictus Pharmaceuticals, Plot No. 21, 26, Street No. NS-2,
Applicant national Industrial Zone (RCCI) Rawat Rawalpindi
Brand Name +Dosage Form + Strength Tecso Capsule 20mg
Esomeprazole magnesium trihydrate (enteric coated pellets)
eq. to esomeprazole…… 20mg
Type of Form Form 5
Approval status of product in NEXIUM® (esomeprazole magnesium) 20mg delayed-release
Reference Regulatory Authorities. capsules (in the form of enteric-coated granules). USFDA
approved
Me-too status Obpra Capsule 20mg by Obson Pharma. Reg. No. 54165
GMP status The firm has been granted DML on the basis of inspection
13.11.2018 & 17.12.2018.
Sourcce of pellets: The firm M/s Vision Pharmaceuticals was
inspected on 11.02.2019, wherein the panel recommended the
grant of GMP certificate.
Remarks of the Evaluator.  The source of pellets is Vision Pharmaceuticals, Islamabad,
wherein all the testing methods are under discussion.
 The pellets have been assayed on the basis of esopemrazole
Mg (%) as trihydrate.
 Decision: Deferred for further delibration regarding assay on the basis of esopemrazole Mg (%) as
trihydrate
Brand Name +Dosage Form + Strength Tecso Capsule 40mg
Esomeprazole magnesium trihydrate (enteric coated pellets)
eq. to esomeprazole…… 40mg
Type of Form Form 5
Approval status of product in NEXIUM® (esomeprazole magnesium) 40mg delayed-release
Reference Regulatory Authorities. capsules (in the form of enteric-coated granules). USFDA
approved
Me-too status Obpra Capsule 40mg by Obson Pharma. Reg. No. 54166
13.11.2018 & 17.12.2018.
Remarks of the Evaluator.  The source of pellets is Vision Pharmaceuticals, Islamabad,
wherein all the testing methods are under discussion.
 The pellets have been assayed on the basis of esopemrazole
Mg (%) as trihydrate.
 Decision: Deferred for further delibration regarding assay on the basis of esopemrazole Mg (%) as
trihydrate
Brand Name +Dosage Form + Strength Ovic Capsule 20mg
Omeprazole (as enteric coated pellets)…… 20mg
Type of Form Form 5
Approval status of product in Losec 20 mg hard gastro-resistant capsules by AstraZeneca
Reference Regulatory Authorities. UK Ltd., Approved by MHRA
Me-too status Omecap Capsule by Next Pharmaceutical Products (Pvt) Ltd,

13.11.2018 & 17.12.2018. Sourcce of pellets: The firm M/s
Vision Pharmaceuticals was inspected on 11.02.2019, wherein
the panel recommended the grant of GMP certificate.
Brand Name +Dosage Form + Strength Ovic Capsule 40mg
Omeprazole (as enteric coated pellets)…… 40mg
Type of Form Form 5
Approval status of product in Losec 40 mg hard gastro-resistant capsules by AstraZeneca
Reference Regulatory Authorities. UK Ltd., Approved by MHRA
Me-too status Omecap Capsule by Next Pharmaceutical Products (Pvt) Ltd,
13.11.2018 & 17.12.2018.
Brand Name +Dosage Form + Strength Syolex Capsule 20mg
Duloxetine HCl (enteric coated pellets) eq. to duloxetine...20mg
PKR 5,000/-: 04.03.2019
Type of Form Form 5
Approval status of product in Dutor 20 mg gastro-resistant capsules, hard. MHRA approved
Me-too status Oxcym DR 20 mg Capsule. Reg. No. 76164
13.11.2018 & 17.12.2018.
Remarks of the Evaluator.  The reference product contains doluxetine HCl (enteric
coated pellets) eq. to Doluxetine…20mg. The firm revised
the salt form in label claim in Form 5 along with submission
of Rs. 5000/- fee.
Duloxetine HCl (enteric coated pellets) eq. to duloxetine..30mg

PKR 5,000/-: 04.03.2019
Type of Form Form 5
Me-too status Oxcym DR 30 mg Capsule. Reg. No. 53101
13.11.2018 & 17.12.2018.
of Rs. 5000/- fee.
Duloxetine HCl(enteric coated pellets) eq. to duloxetine..40mg
PKR 5,000/-: 04.03.2019
Type of Form Form 5
Me-too status Worth capsule 40mg. Reg. No. 68816
13.11.2018 & 17.12.2018.
of Rs. 5000/- fee.
Brand Name +Dosage Form + Strength Ezocin Capsule 250mg
Azithromycin as dihydrate…… 250mg
Type of Form Form 5
Approval status of product in Azithromycin 250 mg Capsules. MHRA approved
Me-too status Azofas 250mg Capsules. Reg. No. 60291

13.11.2018 & 17.12.2018.
Remarks of the Evaluator.  The USP has mentioned amperometric electrochemical
detector with dual glassy carbon electrodes for
assay/analysis. The firm submitted that they will purchase
the same.
Decision: Deferred for amperometric electrochemical detector with dual glassy carbon electrodes
for assay/analysis.
Brand Name +Dosage Form + Strength Thiovin Capsule 4mg

PKR 20,000/-: 14.01.2019
Type of Form Form 5
Finished Product Specification The firm has claimed manufacture‘s specifications.
13.11.2018 & 17.12.2018.
Remarks of the Evaluator.  The firm was asked to provide complete finished product
specifications (list of tests, reference to analytical
procedures, and proposed acceptance criteria). However, the
firm did not submit the same.
 Decision: Approved with innovator‘s specfications.
Brand Name +Dosage Form + Strength Iborine Capsule 200mg
Mebeverine HCl…….200mg
Pharmacological Group Synthetic anticholinergics, esters with tertiary amino group
Type of Form Form 5
Approval status of product in COLOFAC® MR 200mg Capsules. MHRA approved
Me-too status Mebrest-200 Capsule. Reg. No. 80547
13.11.2018 & 17.12.2018.
 Decision: Deferred for provision of complete finished product specifications (list of tests, reference
to analytical procedures, and proposed acceptance criteria)
Brand Name +Dosage Form + Strength Velcox Capsule 100mg

Celecoxib…….100mg
Type of Form Form 5
Me-too status Bexicox 100 Capsule by Medipak Ltd, Lahore. R.No. 23946
13.11.2018 & 17.12.2018.
 Celecoxib also lies in L01 class with ATC code L01XX33,
for which a dedicated or self-contained facility is required as
per decision of 282nd meeting of Registration Board.
 Decision: Apporved with Innovator‘s Specification.
Brand Name +Dosage Form + Strength Velcox Capsule 200mg
Celecoxib…….200mg
Type of Form Form 5
Me-too status Bexicox 200 Capsule by Medipak Ltd, Lahore. R. No. 23947
13.11.2018 & 17.12.2018.
 Celecoxib also lies in L01 class with ATC code L01XX33,
for which a dedicated or self-contained facility is required as
per decision of 282nd meeting of Registration Board.
 Decision: Apporved with Innovator‘s Specification.
Brand Name +Dosage Form + Strength Enxic-F Capsule 3/25mg
Olanzapine…….3mg
Type of Form Form 5
Approval status of product in SYMBYAX (olanzapine and fluoxetine) 3/25mg capsules.
Reference Regulatory Authorities. US-FDA approved
Me-too status Co-Depricap 3/25 Capsule by NabiQasim Karachi.R.#076136
13.11.2018 & 17.12.2018.
Type of Form Form 5
Me-too status Co-Depricap 6/25 Capsule by NabiQasim Karachi. R.#076135
13.11.2018 & 17.12.2018.
Type of Form Form 5
Me-too status Amprexa-F 12/25mg Capsule. Reg. No. 76751
13.11.2018 & 17.12.2018.
Brand Name +Dosage Form + Strength Provic Capsule 150mg
Type of Form Form 5
Finished Product Specification The firm has claimed in-house specifications
13.11.2018 & 17.12.2018.
Type of Form Form 5
13.11.2018 & 17.12.2018.
Type of Form Form 5
Approval status of product in Alzain 75mg Capsules, Hard. MHRA approved
13.11.2018 & 17.12.2018.
Type of Form Form 5
Approval status of product in Alzain 50mg Capsules, Hard. MHRA approved
13.11.2018 & 17.12.2018.
Brand Name +Dosage Form + Strength Vensor Capsule 75mg
Venlafexine HCl (extended release pellets) eq. to
Venlafexine…….75mg
Type of Form Form 5
Approval status of product in EFFEXOR XR® (venlafaxine Extended-Release) 75mg
Reference Regulatory Authorities. Capsules. USFDA approved
Me-too status Vfx Capsule 75mg. Reg. No. 82659
13.11.2018 & 17.12.2018.
Brand Name +Dosage Form + Strength Vensor Capsule 37.5mg
Venlafexine HCl (extended release pellets) eq. to
Venlafexine…….37.5mg
Type of Form Form 5
Approval status of product in EFFEXOR XR® (venlafaxine Extended-Release) 37.5mg
Reference Regulatory Authorities. Capsules. USFDA approved
Me-too status Venomap-SR 37.5mg Capsule. Reg. No. 61332
13.11.2018 & 17.12.2018.
 Decision:Approved

M/s. IQRA Pharmaceuticals, Islamabad ( New License)
Following registration dossiers have been received dated 07/03/ 2019 stating that the firm has been granted
approval of new DML by way of formulation by Central Licensing Board in its 269 th meeting for following
thirteen (13)sections
1. Tablet section (General)
2. Capsule section (General)
3. Cream/Ointment/Gel section
4. Oral liquid syrup section (General)
5. Dry powder oral suspension section (General)
6. Liquid Sterile Ampoule section (General)
7. Liquid Sterile Ampoule section (psychotropic)
8. Tablet section (psychotropic)
9. Sterile Ampoule section (steroid)
10. Sterile infusion/small volume vial section (General)
11. Dry Powder for Injection (Cephalosporin)
12. Capsule section (Cephalosporin)
13. Dry powder oral suspension section (Cephalosporin)
The following applications have been evaluated and presented before the Board
Sr.# Section No. of products No. of molecules
1. Tablet section (General) 14 10
2. Capsule section (General) 15 8
3. Cream /Ointment/Gel Section 05 05
4. Liquid Sterile Ampoule section (psychotropic) 08 07
5. Tablet section (psychotropic) 17 08
6. Sterile Ampoule section (steroid) 04 03
Tablet (General) Section (Human): 10 Molecules/14 Products
1452. Name and address of manufacturer / M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
Brand Name + Dosage Form + Strength Qix 10mg Tablet
Escitalopram as Oxalate…10mg
Diary No. Date of R & I & Fee Dy No. 15569: 07.03.2019 Rs. 20,000/-: 07.03.2019
Type of Form Form-5
Pack Size & Demanded Price 1x14‘s; as per SRO
Approval Status of product in Reference Lexapro® (escitalopram) 10mg film-coated Tablets, for oral
Regulatory Authorities use. USFDA approved
Me-too Status Dipgo Tablet 10mg, film-coated. Reg. No. 85715
GMP Status New License
Decision: Approved
Brand Name + Dosage Form + Strength Losu 25mg Tablets
Levosulpiride…25mg
Type of Form Form 5
Pack Size & Demanded Price 10‘s, 20‘s; As per SRO
Approval Status of product in Reference LEVOPRAID® 25 mg Tablets by TEOFARMA Srl.
Regulatory Authorities Approved by AIFA
Me-too Status Sulvo Tablets 25mg. Reg. No. 31747
Decision: Approved
Brand Name + Dosage Form + Strength Losu 50mg Tablets
Levosulpiride…50mg
Type of Form Form 5
Pack Size & Demanded Price 10‘s, 20‘s; as per SRO
Approval Status of product in Reference LEVOPRAID® 50 mg Tablets by TEOFARMA Srl.
Regulatory Authorities Approved by AIFA
Me-too Status Sulvo Tablets 50mg. Reg. No. 31748
Decision: Approved
Brand Name +Dosage Form + Strength SETRIZ 10mg Tablets
Composition Each film coated tablet contain:
Cetirizine dihydrochloride…….10mg
Pharmacological Group Antihistamines for systemic use
Type of Form Form 5
Pack size & Demanded Price 10‘s,20‘s ,100‘s; As per SRO
Approval status of product in Reference Cetec 10 mg film-coated tablets (Cetirizine hydrochloride).
Regulatory Authorities. MHRA Approved
Me-too status Farozen Tablet. Reg. No. 67914 (does not depict film-coating)
Decision: Approved
Brand Name +Dosage Form + Strength Furbi 100mg Tablets
Composition Each sugar-coated tablet contain:
Flurbiprofen…100mg
Type of Form Form 5
Pack size & Demanded Price 1x10‘s,2x10‘s, 6x5‘s; As per SRO
Approval status of product in Reference Flurbiprofen 100 mg sugar-coated tablets by Mylan Products
Regulatory Authorities. Ltd. MHRA approved
Me-too status Flunifen Tablet by Unipharma (Pvt) Ltd. Reg. No. 81350
Remarks of the Evaluator The firm revised of formulation (label claim, master formula,
and manufacturing outlines) to sugar-coated tablet along with
Decision: Approved
Brand Name +Dosage Form + Strength Moxo 400mg Tablets
Moxifloxacin as HCl…400mg
Pharmacological Group Floroquinolones
Type of Form Form 5
Approval status of product in Reference Avelox® 400mg film-coated tablets. MHRA approved
Me-too status Navilox 400mg Tablet. Reg. No. 85166
Decision: Approved
Brand Name +Dosage Form + Strength I-Quin 250mg Tablets
Levofloxacin as hemihydrate……250mg
Type of Form Form 5
Approval status of product in Reference Evoxil 250 mg film-coated tablets. MHRA approved
Me-too status Levolis 250mg Tablets. Reg. No. 85178
Decision: Approved
Brand Name +Dosage Form + Strength I-Quin 500mg Tablets
Levofloxacin as hemihydrate……500mg
Type of Form Form 5
Approval status of product in Reference Evoxil 500 mg film-coated tablets. MHRA approved
Me-too status Levoquin 500mg Tablet. Reg. No. 85206
Decision: Approved
Brand Name +Dosage Form + Strength Piro-Bd 20mg Tablet
Piroxicam as betacyclodextrin …20mg
(oxicams)
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer‘s specification.
Approval status of product in Reference BREXIN 20 mg scored tablet by Pierre FABRE
Regulatory Authorities. MEDICAMENT. ANSM approved
Me-too status Piram-BX Tablets 20mg. Reg. No. 80594
Decision: Approved with innovator‘s specifications
Brand Name +Dosage Form + Strength D-Fo SR 100mg Tablet
Composition Each prolonged release tablet contains:
Diclofenac Sodium…100mg
Type of Form Form 5
Pack size & Demanded Price 2x10‘s, 3x10‘s; As per SRO
Approval status of product in Reference Dicloflex Retard 100 mg prolonged release tablet. MHRA
Regulatory Authorities. approved
Me-too status Diclorax 100mg Tablet. Reg. # 85498
Remarks of the Evaluator  The firm revised the formulation to prolonged release
tablet along with submission of applicable fee Rs. 5000/-.
 Revision of all compostion, manufacturing outlines
required.
 The reference product contains sub-coat of Copovidone
and Sucrose, and Pigmented film coat of Opadry
02B24025. The dossier does not depict the same.
Decision: Deferred for revision of compostion and manufacturing outlines.
Brand Name +Dosage Form + Strength Tam-P 37.5/325 mg Tablets
Tramadol Hcl…37.5mg
Paracetamol…325mg
Type of Form Form 5
Approval status of product in Reference ULTRACET (tramadol hydrochloride and acetaminophen)
Regulatory Authorities. coated tablets, for oral use. USFDA approved
Me-too status Tril-P Tablet. Reg. No. 78181
Decision: Approved
Brand Name +Dosage Form + Strength Roxil 250mg Tablets
Ciprofloxacin as HCl…250mg
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 250 mg film coated tablets. MHRA approved
Me-too status C-Flox 250mg Tablet. Reg. No. 83720
Decision: Approved
Type of Form Form 5
Me-too status C-Flox 500mg Tablet. Reg. No. 83719
Decision: Approved
Type of Form Form 5
Me-too status CIP Tablets 750 mg. Reg. No. 79347
Decision: Approved
Capsule (General) Section (Human): 08 Molecules/15 Products
Brand Name + Dosage Form + Strength Zito 250mg Capsule
Composition Each hard gelatin capsule contains:
Azithromycin as Dihydrate……250mg
Type of Form Form-5
Pack Size & Demanded Price 1x6‘s, 10‘s; as per SRO
Approval Status of product in Reference Azithromycin 250 mg Capsules. MHRA approved
Me-too Status Azofas 250mg Capsules. Reg. No. 60291

The USP has mentioned amperometric electrochemical
detector with dual glassy carbon electrodes for
assay/analysis. The firm submitted that they will
purchase the said electrode.
Decision: Deferred for provision of amperometric electrochemical detector with dual glassy
carbon electrodes for assay/analysis.
Brand Name + Dosage Form + Strength Nero-P 25mg Capsule
Pregabalin…25mg
Type of Form Form-5
Pack Size & Demanded Price 2x7‘s, 2x14‘s, 30‘s; as per SRO
Approval Status of product in Reference Alzain 25 mg Capsules, Hard. MHRA approved
Me-too Status Zeegap 25 mg Capsules. Reg. No. 47357
Pregabalin…50mg
Type of Form Form-5
Me-too Status Scirica 50mg Capsule. Reg. No. 82187
Pregabalin…75mg
Type of Form Form-5
Pregabalin…100mg
Type of Form Form-5
Brand Name + Dosage Form + Strength Piriq 20mg Capsule
Piroxicam…20mg
(oxicams)
Type of Form Form-5
Pack Size & Demanded Price 1x10‘s, 20‘s, 100‘s; as per SRO
Approval Status of product in Reference FELDENE 20mg capsules. MHRA approved
Me-too Status FELDENE 20mg capsules. Reg. No. 6349
Decision: Approved
Brand Name + Dosage Form + Strength Fentiq 150mg Capsule
Fluconazole…150mg
Pharmacological Group Antimycotics for systemic use
Type of Form Form 5
Pack Size & Demanded Price 1x10‘s, 20‘s, 100‘s; as per SRO
Approval Status of product in Reference Fluconazole 150mg capsule. MHRA approved
Me-too Status Fungon Capsules 150mg. Reg. No. 55353
Decision: Approved
Brand Name + Dosage Form + Strength Reso 40mg Capsule
Enteric coated pellets of Esomeprazole magnesium trihydrate
Eq. to Esomeprazole…40mg
Type of Form Form 5
Pack Size & Demanded Price 2x7, 20‘s, 100‘s; as per SRO
Approval Status of product in Reference NEXIUM® (esomeprazole magnesium) 40mg delayed-
Regulatory Authorities release capsules (in the form of enteric-coated granules).
USFDA approved
Me-too Status Obpra Capsule 20mg by Obson Pharma. Reg. No. 54166
inspected on 11.02.2019, wherein the panel recommended
Remarks of the Evaluator  The pellets have been assayed on the basis of
esopemrazole Mg (%) as trihydrate.
Decision: Approved
Brand Name + Dosage Form + Strength Reso 20mg Capsule
Enteric coated pellets of Esomeprazole magnesium trihydrate
Eq. to Esomeprazole…20mg
Type of Form Form 5
Approval Status of product in Reference NEXIUM® (esomeprazole magnesium) 40mg delayed-
Regulatory Authorities release capsules (in the form of enteric-coated granules).
USFDA approved
Me-too Status Obpra Capsule 20mg by Obson Pharma. Reg. No. 54165
Source of pellets: The firm M/s Surge Pharma was inspected
on 22.02.2018 and 04.05.2018, wherein it was concluded that
the firm has maintained fair level of GMP compliance.
Remarks of the Evaluator  The pellets have been assyed on the basis of
esopemrazole Mg (%) as trihydrate.
 The pellets of Sruge of Pharma have been assayed and
tested for stability with in-house specifications.
Decision: Approved
Brand Name + Dosage Form + Strength G-OM 20mg Capsule
Enteric coated pellets of Omeprazole Eq. to
Omeprazole….20mg
Type of Form Form 5
Approval Status of product in Reference Losec 20 mg hard gastro-resistant capsules by AstraZeneca
Regulatory Authorities UK Ltd., Approved by MHRA
Me-too Status Omecap Capsule by Next Pharmaceutical Products (Pvt) Ltd,

Decision: Approved
Brand Name + Dosage Form + Strength G-OM 40mg Capsule
Enteric coated pellets of Omeprazole Eq. to
Omeprazole….40mg
Type of Form Form 5
Approval Status of product in Reference Losec 40 mg hard gastro-resistant capsules by AstraZeneca
Regulatory Authorities UK Ltd., Approved by MHRA
Me-too Status Omecap Capsule by Next Pharmaceutical Products (Pvt) Ltd,
Decision: Approved
Brand Name + Dosage Form + Strength Sero-T 20mg Capsule
Enteric coated pellets of Duloxetine HCl Eq. to
Duloxetine…20mg
Type of Form Form 5
Pack Size & Demanded Price 2x7‘s, 4x7‘s, 1x10‘s; as per SRO
Approval Status of product in Reference Depalta 20mg gastro-resistant capsules, hard. MHRA
Me-too Status Oxcym DR 20 mg Capsule. Reg. No. 76164
Decision: Approved
Duloxetine…30mg
Type of Form Form 5

Decision: Approved
Duloxetine…60mg
Type of Form Form 5
Sourcce of pellets: The firm M/s Surge Pharma was
inspected on 22.02.2018 and 04.05.2018, wherein it was
concluded that the firm has maintained fair level of GMP
compliance.
Decision: Approved
1480. Name and address of manufacturer M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
/ Applicant National Industrial Zone, Rawat, Islamabad, Pakistan
Brand Name + Dosage Form + Strength Doxy-Liq 100mg Capsule
Doxycycline as Hyclate…100mg
Pharmacological Group Tetracyclines
Type of Form Form 5
Pack Size & Demanded Price 10‘s, 20‘s, 30‘s, 100‘s; as per SRO
Approval Status of product in Reference Doxycycline 100mg Capsules. MHRA approved
Me-too Status Sodox Capsule 100mg. Reg. No. 84061
Decision: Approved
Tablet (Psychotropic) Section (Human): 08 Molecules/17 Products
Brand Name + Dosage Form + Strength Al-Proz 0.25mg Tablet
Alprazolam…0.25mg
Type of Form Form-5

Pack Size & Demanded Price 10‘s, 3x10‘s, 5x10‘s; as per SRO
Approval Status of product in Xanax 250 microgram Tablets. MHRA approved
Me-too Status Lamzo 0.25mg Tablet. Reg. No. 57867
Decision: Approved
Brand Name + Dosage Form + Strength Al-Proz 0.5mg Tablet
Alprazolam…0.5mg
Type of Form Form-5
Approval Status of product in Xanax 500 microgram Tablets. MHRA approved
Me-too Status Lamzo 0.5mg Tablet. Reg. No. 57868
Decision: Approved
Brand Name + Dosage Form + Strength Al-Proz 1mg Tablet
Alprazolam…01mg
Type of Form Form-5
Approval Status of product in ALPRAZOLAM-GA alprazolam 1mg tablet. TGA approved
Me-too Status Lamzo 1mg Tablet. Reg. No. 57869
Decision: Approved
Brand Name + Dosage Form + Strength Al-Proz 2mg Tablet
Alprazolam…2mg
Type of Form Form-5
Approval Status of product in ALPRAZOLAM-GA alprazolam 2mg tablet. TGA approved
Me-too Status M-Zolam 2mg Tablet. Reg. No. 58406
Decision: Approved
Brand Name + Dosage Form + Strength Lorvan 1mg Tablet
Lorazepam…1mg
Type of Form Form-5
Approval Status of product in Ativan® (lorazepam) 1 mg Tablets. USFDA approved
Me-too Status Lorze 1mg Tablet. Reg. No. 61233
Decision: Approved
Brand Name + Dosage Form + Strength Lorvan 2mg Tablet
Lorazepam…1mg
Type of Form Form-5
Approval Status of product in Ativan® (lorazepam) 2 mg Tablets. USFDA approved
Me-too Status Lorze 2mg Tablet. Reg. No. 61234
Decision: Approved
Brand Name + Dosage Form + Strength Dezopam 5mg Tablet
Diazepam…5mg
Type of Form Form-5
Pack Size & Demanded Price 100‘s, 3x10‘s, 1000‘s; as per SRO
Approval Status of product in Diazepam 5 mg Tablets. MHRA approved
Me-too Status Dalium 5mg Tablet. Reg. No. 61854
Decision: Approved
Brand Name + Dosage Form + Strength Dezopam 10mg Tablet
Diazepam…10mg
Type of Form Form-5
Pack Size & Demanded Price 100‘s, 3x10‘s, 1000‘s; as per SRO
Approval Status of product in Diazepam 10 mg Tablets. MHRA approved
Me-too Status Dalium 10mg Tablet. Reg. No. 61855
Decision: Approved
Brand Name + Dosage Form + Strength Epitop 25mg Tablets
Topiramate…25mg
Type of Form Form 5
Approval Status of product in Topamax® 25 mg film-coated tablets. MHRA approved
Me-too Status Erbro 25mg Tablet Tablet. Reg. No. 80384
Remarks of the Evaluator  Topiramate does not look to be psychotropic drug.
Decision: Deferred for consideration on its turn.
Brand Name + Dosage Form + Strength Epitop 50mg Tablets
Topiramate…50mg
Type of Form Form 5
Approval Status of product in Topamax® 50 mg film-coated tablets. MHRA approved
Me-too Status Topister Tablet 50mg. Reg. No. 82548
Remarks of the Evaluator  Topiramate does not look to be psychotropic drug.
Decision: Deferred for consideration on its turn
Brand Name + Dosage Form + Strength Co-Pam 1mg Tablet
Clonazepam…1mg
Type of Form Form 5
Approval Status of product in KLONOPIN TABLETS 1mg. USFDA approved
Me-too Status Curo 1mg Tablets. Reg. No. 65700
Decision: Approved
Brand Name + Dosage Form + Strength Co-Pam 0.5mg Tablet
Clonazepam…0.5mg
Type of Form Form 5
Approval Status of product in KLONOPIN TABLETS 0.5mg. USFDA approved
Me-too Status Cozepam 0.5mg Tablet. Reg. No. 64716
Decision: Approved
Brand Name + Dosage Form + Strength Co-Pam 2mg Tablet
Clonazepam…2mg
Type of Form Form 5
Approval Status of product in KLONOPIN TABLETS 2mg. USFDA approved
Me-too Status Cozepam 2mg Tablet. Reg. No. 64715
Decision: Approved
Brand Name + Dosage Form + Strength Zol-P 10mg Tablet
Zolpidem tartrate…10mg
Type of Form Form 5
Approval Status of product in Stilnoct 10mg film-coated tablets. MHRA approved
Me-too Status Ensomie Tablet 10mg. Reg. No. 85026
Decision: Approved
Brand Name + Dosage Form + Strength Brozil 1.5mg Tablets
Bromazepam…1.5mg
Type of Form Form 5
Approval Status of product in BROMAZEPAM ARROW 1.5 mg tablets. ANSM approved
Me-too Status Yazd 1.5mg Tablet. Reg. No. 71219
Decision: Approved
Brand Name + Dosage Form + Strength Brozil 3mg Tablets
Bromazepam…3mg
Type of Form Form 5
Approval Status of product in LEXOTAN bromazepam 3mg tablet. TGA approved
Me-too Status Arbro Tablet 3mg. Reg. No. 78887
Decision: Approved
Brand Name + Dosage Form + Strength Bital 30mg Tablet
Phenobarbital………..……. 30 mg
Pharmacological Group Barbiturates and derivatives
Type of Form Form 5
Pack Size & Demanded Price 100‘s, 60‘s, 1000‘s; as per SRO
Approval Status of product in Phenobarbital 30mg Tablets. MHRA approved
Me-too Status Fenotal 30 mg Tablets. Reg. No. 79323
Decision: Approved
Liquid Injectable (Steroidal hormones) Section (Human):
Brand Name + Dosage Form + Strength Tipomed 80mg/ml Injection
Methylprednisolone Acetate…80mg
Pharmacological Group Glucocorticoids
Type of Form Form-5
Pack Size & Demanded Price 1x1ml; as per SRO
Approval Status of product in Reference DEPO-MEDROL® (methylprednisolone acetate injectable
Regulatory Authorities suspension, USP) single dose vial (1ml). USFDA approved
Me-too Status Radilem Suspension 80mg (each vial contains; Sterile,
micronized methylprednisolone acetate.80.0mg). R.#033424
Remarks of the Evaluator  The firm has mentioned injection dosage form. The
composition dosage from is injectable suspension.
Decision: Approved
Brand Name + Dosage Form + Strength Tipomed 40mg/ml Injection
Methylprednisolone Acetate…40mg
Type of Form Form-5
Approval Status of product in Reference DEPO-MEDROL® (methylprednisolone acetate injectable
Regulatory Authorities suspension, USP) single dose vial (1ml). USFDA approved
Me-too Status Co-Sterol Injection (1 ml suspension in vial). Reg. No. 63094
Decision: Approved
Brand Name + Dosage Form + Strength Trimacort 40mg Injection
Triamcinolone Acetonide…40mg
Type of Form Form-5
Approval Status of product in Reference KENACORT A40 triamcinolone acetonide 40mg/1 mL
Regulatory Authorities injection, suspension ampoule. TGA approved
Me-too Status Dexafort Injection (1ml). Reg. No. 69744 (deos not depict
vial or ampule).
Remarks of the Evaluator  You have mentioned injection dosage form. The
composition dosage from is injectable suspension.
Decision: Approved
Brand Name + Dosage Form + Strength Dixadron 4mg/ml Injection
Dexamethasone Phosphate as Sodium…4mg
Type of Form Form-5
Approval Status of product in Reference Dexamethasone 3.3 mg/ml solution for injection 1 ml
Regulatory Authorities ampule. (Each ml of solution for injection contains 4.00 mg
of dexamethasone phosphate (as 4.37 mg dexamethasone
sodium phosphate) equivalent to 3.32 mg of dexamethasone
base). MHRA approved
Me-too Status Histopak Injection (1ml). Reg. No. 57655 (deos not depict
vial or ampule).
Decision: Approved
Liquid Sterile Ampoule (psychotropic)Section (Human):
Brand Name + Dosage Form + Strength Dezopam 5mg/ml Injection (2ml)
Diazepam…5mg
Type of Form Form-5
Approval Status of product in Reference Diazepam 5mg/ml Solution for Injection (2ml, 4ml). MHRA
Me-too Status DIAZEPAM INJECTION 2ml ampule. Reg. No. 01117
Remarks of the Evaluator  Submit updated Form 5 duly signed by all concerned
persons.
 All signatures shall be in original rather scanned one.
Decision: Deferred for submission for rectification of shortcomings.
Brand Name + Dosage Form + Strength Bital 200mg/ml Injection (1ml)
Phenobarbital Sodium…200mg
Pharmacological Group Barbiturates derivatives
Type of Form Form-5
Approval Status of product in Reference Phenobarbital Sodium 200mg/ml Injection (1ml). MHRA
Me-too Status P-Bar Injection 1ml ampule. Reg. No. 79731
Remarks of the Evaluator Proof/justification is required about using Sodium edetate.
Decision: Deferred for justification about using Sodium edetate.
Brand Name + Dosage Form + Strength Bupnor 0.3mg/ml Injection (1ml)
Buprenorphine HCl Eq. to Buprenorphine…0.3mg
Pharmacological Group Oripavine derivatives
Type of Form Form-5
Approval Status of product in Reference Temgesic Injection 1ml ampule. MHRA approved
Me-too Status Enorfine Injection 1ml. Reg. No. 41528 (deos not show
ampule or vial)
Decision: Approved

Brand Name + Dosage Form + Strength Morine 10mg/ml Injection (1ml)
Morphine Sulphate Pentahydrate Eq. to Morphine
Sulphate…10mg
Pharmacological Group Natural opium alkaloids
Type of Form Form-5
Pack Size & Demanded Price 5‘s; as per SRO
Approval Status of product in Reference Morphine Sulfate Injection BP 10mg in 1ml ampule. MHRA
Me-too Status Morfscot Injections 10mg. Reg. No. 28300 (deos not show
ampule or vial)
Remarks of the Evaluator  The reference and me-too products do not have API in
hydrate form. Justify.
 In case you prove reference products with API in hydrate
form, adjust the quantity of API in master formula (only)
as per salt factor.
Decision: Deferred for:
 Proof proof of International availability of same dosage form with same strength, salt
form and same pack size in reference regulatory authority as defined in 275 th meeting of
the Registration Board, and me-too product with same strength, salt form and same pack
size approved by DRAP and adjusmtnet of weight of API in Master Formula, or
 Revision of API as for abovementioned reference product.
Brand Name + Dosage Form + Strength Morine 20mg/ml Injection (1ml)
Morphine Sulphate Pentahydrate Eq. to Morphine
Sulphate…20mg
Pharmacological Group Natural opium alkaloids
Type of Form Form-5
Pack Size & Demanded Price 5‘s; as per SRO
Approval Status of product in Reference Morphine Sulfate Injection BP 20mg in 1ml ampule. MHRA
Me-too Status Morfscot Injections 10mg. Reg. No. 28301 (deos not show
ampule or vial)
Remarks of the Evaluator  The reference and me-too products do not have API in
hydrate form. Justify.
 In case you prove reference products with API in hydrate
form, adjust the quantity of API in master formula (only)
as per salt factor.
Decision: Deferred for:
the Registration Board, and me-too product with same strength, salt form and same pack
size approved by DRAP and adjusmtnet of weight of API in Master Formula, or
 Revision of API as for abovementioned reference product.

Brand Name + Dosage Form + Strength Telwin 30mg/ml Injection
Pentazocine as lactate …30mg
Diary No. Date of R & I & Fee Dy No. 15581: 07.03.2019
Rs. 20,000/-: 07.03.2019
Pharmacological Group Benzomorphan derivatives
Type of Form Form-5
Finished Product Specification USP (a sterile solution of Pentazocine in
Water for Injection, prepared with the aid of Lactic Acid).
Pack Size & Demanded Price 1x5, 1x10, 25 ampule, 100 ampule; As per SRO
Approval Status of product in Reference Could not be confirmed
Me-too Status AmezocinInjection. Reg. No. 65939 (deos not show ampule
or vial)
Remarks of the Evaluator  Clarification is required about the pack size.
 The firm revised the salt form in line with the reference
product along with submission of Rs. 5000/- fee.
 Clarification of pack size.
the Registration Board,
Brand Name + Dosage Form + Strength Nilbo 10mg/ml Injection
Nalbuphine hydrochloride….10mg
Pharmacological Group Morphinan derivatives
Type of Form Form-5
Finished Product Specification The firm has claimed manufactuer‘s specifications.
Pack Size & Demanded Price 2x5 ampule PVC contour cellular package 1 contour cellular
in a carton box.
Approval Status of product in Reference NUBAIN (Nalbuphine Hydrochloride) Injection, 10 mg/mL
Regulatory Authorities (1ml ampule). Health Canada approved
Me-too Status Nalburax Injection. Reg. No. 28830 (deos not show ampule
or vial)
Remarks of the Evaluator  Clarification is required about the pack size.
Decision: Deferred for consideration on its turn as neither Narcotic or Psychotropic as per INCB.
Brand Name + Dosage Form + Strength Opidol 100mg/2ml Injection
Tramadol hydrochloride….100mg
Pharmacological Group Other opioids
Type of Form Form-5
Pack Size & Demanded Price 2mlx10‘s;, 2mlx30‘s; as per SRO
Approval Status of product in Reference Tramadol 50mg/ml Solution for Injection or Infusion (2ml).
Regulatory Authorities MHRA approved
Me-too Status Welmadol Injection (2ml). Reg. No. 52629 (deos not show
ampule or vial)
Decision: Deferred for consideration on its turn as neither Narcotic or Psychotropic as per INCB
Cream/ointment/Gel Section (Human): 05 Molecules/05 Products
Brand Name + Dosage Form + Strength Fucilid 15g Cream
Fusidic Acid…20mg
Pharmacological Group Other antibiotics for topical use
Type of Form Form-5
Pack Size & Demanded Price 15g, 30g; as per SRO
Approval Status of product in Reference Fusidic Acid 2% Cream. MHRA approved
Me-too Status Tica-H Cream. Reg. No. 54358
Decision: Approved
Brand Name + Dosage Form + Strength Fucilid-H Cream
Fusidic Acid…20mg
Hydrocortisone Acetate…10mg
Pharmacological Group Corticosteroids + Fusidic acid (not in ATC)
Type of Form Form-5
Pack Size & Demanded Price 15g, 30g; as per SRO
Approval Status of product in Reference Fucidin H Cream. MHRA approved
Me-too Status Dercid -H Cream. Reg. No. 24166
Remarks of the Evaluator Submit updated Form 5 duly signed by all concerned persons
Decision: Deferred for submission of updated Form 5.
Brand Name + Dosage Form + Strength Areeba Trim Cream
Fluocinolone Acetonide…0.1mg
Hydroquinone…40mg
Tretinoin…0.5mg
Pharmacological Group Corticosteroids, potent (group III) in combination with other
dermatological and retinoids for topical use
Type of Form Form 5
Pack Size & Demanded Price 30g; as per SRO
Approval Status of product in Reference TRI-LUMA® (fluocinolone acetonide, hydroquinone, and
Regulatory Authorities tretinoin) cream, 0.01%, 4%, 0.05% for topical use by
Galderma Labs LP. US-FDA approved
Me-too Status Trimelasin Cream by Valor Pharmaceuticals. R.No. 31104

Brand Name + Dosage Form + Strength Trima-H Cream
Clotrimazole…10mg
Hydrocortisone as Acetate…10mg
Type of Form Form 5
Approval Status of product in Reference Canesten HC Cream. MHRA approved
Me-too Status Aquazole Cream 10gm by Martin Dow. Reg. No. 67931
(contains Hydrocortisone Acetate instead of Hydrocortisone
as Acetate)
Remarks of the Evaluator The firm revised hydrocortisone to hycdrocortisone acetate in
master Formula and adjusted its quantity as per salt factor.
Brand Name + Dosage Form + Strength Pendic Gel 1%
Diclofenac diethylamine 11.6 mg eq. to Diclofenac
sodium…..10mg
Type of Form Form 5
Approval Status of product in Reference VOLTAREN OSTEO GEL diclofenac diethylamine
Regulatory Authorities 11.6mg/g (1.16%) tube. USFDA approved. With no
equivalency.
Me-too Status Dicmaf 1% Gel. With label claim ―each gram contains:
Diclofenac Diethylamine 11.6 mg eq. to Diclofenac
Sodium.10 mg‖. Reg No. 79899
Remarks of the Evaluator The compostions depict that the product is emulsion. Clarify.
Decision: Deferred for clarification about the compositions.

(Veterinary).
a. Deferred Cases
The firm has been granted additional section Oral powder (penicillin) on the basis of inspection dated 13-
14.09.2018. The firm has applied for 07 generics (08 products).
1515. Name and address of manufacturer / Mylab Pvt. Ltd Khankah Shareef Bahawalpur
Applicant
Brand Name +Dosage Form + Strength Dyro-X Oral Powder
Composition Each 12grams contain:
Neomycin sulphate…… 400mg
Streptomycin sulphate….400mg
Sulfaguanidine………4g
Kaolin……………….4g
Pectin………………..400mg
Bismuth subnitrate……2g
Vitamin A acetate……..80,000IU
Pharmacological Group Combination of antibiotics with antidiarrheals and vitamin A
(not available in ATC)
Type of Form Form 5
Finished Product Specification The firm has claimed manufacture‘s specifications
Pack size & Demanded Price Carton box of 6 sachet; The firm has submitted that the price is
decontrolled.
Me-too status Diarroban Powder. Reg. No. 026438
GMP status The firm has been granted additional section Oral powder
(penicillin) on the basis of inspection dated 13-14.09.2018.
Remarks of the Evaluator.  The firm has mentioned in master Formula that ―appropriate
overage is added to compensate the potency loss on storage‖.
The firm was asked for clarification. However, the firm did
not replied.
 The firm was asked to submit complete updated Form 5 duly
signed by all concerned persons. However, the firm submitted
incomplete Form 5.
 The firm was asked to submit complete finished product
specifications and testing method. However, the firm did not
submit the same.
 The firm has claimed the product on priority for Oral
Powder (penicillin) Veterinary. However, the product is not
related to the said section.
Previous decision The Board in its 288th meeting deferred the case for the
following:
 Justification on scientific basis for addition of overage in
master formulation.
 For submission of complete Form-5
related to the said section
Evaluation by PEC  The firm removed overage
 Updated Form 5 submitted
 The firm has claimed innovator‘s specifications
 Decision: Deferred for consideration on its turn.
Applicant
Brand Name +Dosage Form + Strength Diarin Oral Powder
Composition Each 28grams contain:
Neomycin sulphate…… 0.538g
Streptomycin sulphate….0.676g
Sulfaguanidine………5g
Phthalyl sulphathiazole……….1.5g
Riboflavin………..0.1g
Nicotinamide……0.5g
Pharmacological Group Combination of antibiotics with antidiarrheals and vitamin (not
available in ATC)
Type of Form Form 5
Finished Product Specification The firm has claimed Innovator‘s specifications
Pack size & Demanded Price 28g, 100g, 500g, 1000g, 25kg; The firm has submitted that the
price is decontrolled.
not replied.
incomplete Form 5.
submit the same.
following:
DRAP (generic/me-too status) alongwith registration
master formulation.
Powder (penicillin) Veterinary. However, the product is
not related to the said section
 Decision: Deferred for consideration on its turn
Applicant
Brand Name +Dosage Form + Strength Listin-Hi WSP

Amoxicillin trihydrate…… 200mg
Lincomycin base….88mg
Spectinomycin base………88mg
Vitamin E Acetate……30mg
PKR 20,000/-: 27.02.2018
Pharmacological Group Combination of antibiotics with vitamin E (not available in
ATC)
Type of Form Form 5
Pack size & Demanded Price 1kg, 2.5kg, 5kg, 10kg, 20kg, 25kg; The firm has submitted that
the price is decontrolled.
Me-too status Lincamox-S Water Soluble Powder. Reg. No. 63788
not reply.
incomplete Form 5.
submit the same.
 The me-too product contains Lincomycin Base; however,
the firm has revised Lincomycin Base to Lincomycin as HCl
 The me-too product contains Vitamin E acetate. The firm
was asked for correction in Form 5 and Master Formula along
with submission of applicable fee. However, the firm did not
revise Form 5 with submission of fee.
following:
master formulation.
 Revision of formulation in line with reference product along
approved by DRAP with submission of fee
 The firm again revised lincomycin HCl to Lincomycin base.
 The firm revised Vitamin E to Vitamin E acetate with
submission of fee Rs. 5000/- (Dy. No. 5552; 08.05.2019).
Applicant
Brand Name +Dosage Form + Strength Phenox Plus WSP
Phenoxymethylpenicillin…….800mg
Pharmacological Group Beta-lactamase sensitive penicillins
Type of Form Form 5
Pack size & Demanded Price 100g, 500g, plastic bottles; 1 kg, 10kg, 25kg, plastic bag; As per
SRO (10% less than the brand leader)
Remarks of the Evaluator.  Undertakings have not been signed.
 Reference (Pharmacopeia / innovator / manufacturer) for
finished product specifications is required.
 Submit clear stepwise manufacturing outlines.
 Complete finished product specifications and testing method
are needed.
 Details of environmental control processing including waste
disposal management.
 Proof of me-too product (name and registration number)
with same dosage form, same salt form and same strength is
required
 Justification for overage is required.
 Signature at the beginning of Form 5 is missing.
 The firm has mentioned the word flavor. The name of flavor
that will be used in the product is required.
following:
master formulation.
 Submision of clear stepwise manufacturing outlines and
testing methods.
Evaluation by PEC  The firm removed overage.
 Updated Form 5 submitted.
 Me-too status could not be confirmed
 The name of flavor that will be used in the product is required.
Applicant
Brand Name +Dosage Form + Strength Klavimox WSP
Composition Each 100 grams contain:
Amoxicillin as trihydrate…….16g
clavulanic acid as potassium salt ……..4g
Pharmacological Group Amoxicillin and beta-lactamase inhibitor
Type of Form Form 5
Pack size & Demanded Price 100g, 500g, 1 kg, 10kg, 25kg,; As per SRO (10% less than the
brand leader)
Me-too status PRIMOX-PLUS WATER SOLUBLE POWDER. Reg. No.
074026
not reply.
incomplete Form 5.
submit the same.
 The product is intended for oral use. In the proposed dosage,
the firm has mentioned 1ml/20kg body weight, which is
submitted for Clavimox Injection. Clarification is was asked
from the firm. The firm did not reply.
 Correction of ‗clavulanic acid as potassium‘ to ‗potassium
clavulanate‘ is required in Master Formula.
 The firm changed clavulanic acid to clavulanic acid as
potassium salt without submission of fee.
 Available in USP, wherein the monograph is for ―for oral
suspension‘.
following:
master formulation.
signed by all concerned persons. However, the firm
submitted incomplete Form 5.
specifications and testing method. However, the firm did
not submit the same.
 Correction of amoxicillin as trihydrate to amoxicillin
trihydrate in Master Formula is required.
disposal management is needed.
submitted for Clavimox Injection. Clarification is required
from the firm.
 Correction of ‗clavulanic acid as potassium‘ to ‗potassium
clavulanate‘ is required in Master Formula.
submitted for Clavimox Injection.
 Available in USP, wherein the monograph is for ―for oral

suspension‘.
 Submission of fee for revision of salt form.
 Submission of correct dosage
 Clairifaction about the dosage form.
Applicant
Brand Name +Dosage Form + Strength Avipen 325 WSP
Phenoxymethylpenicillin…….325mg
Type of Form Form 5
Pack size & Demanded Price 100g, 500g; 1 kg, 10kg, 25kg; As per SRO (10% less than the
brand leader)
Me-too status PHENOXYPEN WATER SOLUBLE POWDER. Reg. No.
081303
not reply.
incomplete Form 5.
submit the same.
disposal management are missing.
 The me-too product contains phenoxymethylpenicillin
(293mg/g) eq. to potassium phenoxymethylpenicillin
(325mg/g). The firm was asked for correction is required in
label claim (Form 5 only) along with submission of
applicable fee. The firm neither changed the label claim in
Form 5 nor submitted the applicable fee.
following:
master formulation.
(325mg/g). The firm was asked for correction is required in
label claim (Form 5 only) along with submission of
applicable fee. The firm neither changed the label claim in

Form 5 nor submitted the applicable fee.
(325mg/g). The firm was asked for correction in label claim
(Form 5 only) along with submission of applicable fee. The
firm submitted Rs. 5000/- fee but revision of label claim is
required.
 Decision: Deferred for revision of label claim.
Applicant
Brand Name +Dosage Form + Strength Avigrow 100 WSP
Composition Each kg contains:
Procaine penicillin…….12g
Streptomycin sulfate ……36g
Zinc bacitracin……52g
Type of Form Form 5
Pack size & Demanded Price 100g, 500g; 1 kg, 10kg, 25kg; As per SRO (10% less than the
brand leader)
Me-too status PENSTREP POWDER. Reg. No. 017923
not reply.
incomplete Form 5.
submit the same.
 The me-too product contains streptomycin sulphate. The
firm revised ‗streptomycin‘ to ‗streptomycin sulphate‘. The
firm was asked to submit applicable fee. Then firm again
changed streptomycin sulphate to streptomycin.
following:
master formulation.

 • The me-too product contains streptomycin sulphate. The
firm revised ‗streptomycin‘ to ‗streptomycin sulphate‘. The
firm was asked to submit applicable fee. Then firm again
 The firm revised ‗streptomycin‘ to ‗streptomycin sulphate‘.
The firm was asked to submit applicable fee. Then firm again
 The firm has now revised streptomycin to streptomycin
sulfate along with submission of Rs. 5000/- fee.
 The firm submitted details of environmental control
processing.
Applicant
Brand Name +Dosage Form + Strength Spectamox Plus WSP
Composition Each 100 grams contain:
Amoxicillin trihydrate…….20g
Lincomycin……….8.8g
Spectinomycin…….8.8g
Pharmacological Group Amoxicillin and beta-lactamase inhibitor
Type of Form Form 5
Pack size & Demanded Price 100g, 500g, plastic bottles; 1 kg, 10kg, 25kg, plastic bag; As per
SRO (10% less than the brand leader)
Me-too status SPECLIMOX ORAL POWDER. Reg. No. 033235
Remarks of the Evaluator.  Undertaking at the end of form 5 is missing.
 The me-too product contains amoxicillin trihydrate. The
firm has mentioned amoxicillin trihydrate.
 Justification for overage is required.
following:
master formulation.
 Undertaking at the end of form 5 is missing.
 The me-too product contains amoxicillin trihydrate. The
firm has mentioned amoxicillin as trihydrate.
Evaluation by PEC  The firm removed overage and flavor.
 The firm revised amoxicillin as trihydrate to amoxicillin
trihydrate.
 The firm submitted details of environmental control
processing.
 The firm removed the flavor form the compositions.
 Decision: Approved with innovator‘s spcifications
Case No. 05: Registration Applications of Categories to be Considered on Priority.

Local manufacturing applications of priority categories defined by Registration Board in its 257 th
meeting
1523. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Factory Plot # 122, Block B,
Applicant Phase V, Industrial Estate, Hattar, District Haripur, Pakistan
Brand Name +Dosage Form + Strength Nelfi 250mg tablet
Nelfinavir as Mesylate…..250mg
Pharmacological Group Protease inhibitors
Type of Form Form 5
Finished Product Specification IP
Approval status of product in VIRACEPT® (nelfinavir mesylate) film-coated Tablets, for
Reference Regulatory Authorities. oral use USFDA approved
Me-too status NELFIN–250 Tablets. Reg. No.41115
GMP status The firm was inspected on 04.09.2018 & 26.09.2018 with the
conclusion:
As per observation made, facilities of production and quality
control inspected, technical staff employed and keeping in view
the overall GMP compliance status of the firm, the panel
unanimously recommends the renewal of DML 000614 by way
of formulation granted to M/s Welmark KPK.
Remarks of the Evaluator.  The firm revised Nelfinavir Mesylate to Nelfinavir as
Mesylate in Form 5 without any fee.
 Decision: Deferred for submission of fee
1524. Name and address of manufacturer / Aulton Pharmaceutical, Plot No. 84/1, Block A, Phase V,
Applicant Industrial Estate, Hattar Pakistan
Brand Name +Dosage Form + Strength Leflunomalt 10mg tablet
Leflunomide…… 10mg
Type of Form Form 5
Approval status of product in Reference Leflunomide 10 mg Film-coated Tablets Approved by
Regulatory Authorities. MHRA
Me-too status Zefora Tablets 10mg. Reg. No.66488
GMP status The firm was last inspected on 13.02.2018, wherein it was
concluded that "Overall the firm was in good working
condition with proper documentation, adequate Equipments
both in production and quality control and qualified staff for
performing the manufacturing and analysis of the
manufactured products in accordance with the cGMP
guidelines. Some of the minor shortcomings as described
above were identified to the firm for immediate rectification.
Based on the premises inspected, the qualified staff met and
documentation reviewed, it is concluded that M/s Aulton
Pharma Industrial Estate Hatter operate at good level of
compliance with cGMP guidelines"
Remarks of the Evaluator.  The firm was asked to provide clear and complete
manufacturing outlines mentioning the addition/mixing of
each component of the formulation including APIs. The
firm submitted inomplete having instructions/precautionary
measures.
b. Export facilitation
Following three cases were received from section I & V-I vide letter No. F.1-9/2013-Reg-I dated 19.02.2019.
According to the contents of the letter the firm has claimed two molecules (03 products) to be considered on
priority basis in lieu of export facilitation.
1525. Name and address of manufacturer / Selmore Pharmaceuticals (Pvt.) Ltd., 36 Km, Multan Road
Applicant Lahore
Brand Name +Dosage Form + Strength Triox Drench
Composition Each 100 ml contain:
Oxfendazole……...2.265g
Triclabendazole…….8.50g
Pharmacological Group Other antitrematodal agents + Oxfendazole (not in ATC)
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml; Decontrolled
Me-too status VORCID SUSPENSION. Reg. No. 063563
GMP status The firm was inspected on 05.03.2018, 17.08.2018 &
16.10.2018, wherein renewal of DML: was recommended.
 Decision: Approved with innovator‘s specifcation
Applicant Lahore
Brand Name +Dosage Form + Strength Amoxygent Forte IM Injection 50ml
Amoxicillin trihydrate……...150mg
Gentamycin sulfate eq. to Gentamycin……40mg
Pharmacological Group Penicillins with extended spectrum + aminoglycoside (not in
ATC)
Type of Form Form 5
Pack size & Demanded Price 50ml; Decontrolled
Me-too status GENTAMOX INJECTION (100ml). Reg. No. 80160
Remarks of the Evaluator.  The registration board in its meeting 287th meeting approved
100ml on the basis of 50ml.
Applicant Lahore
Brand Name +Dosage Form + Strength Amoxygent Forte IM Injection 100ml
Amoxicillin trihydrate……...150mg
Gentamycin sulfate eq. to Gentamycin……40mg
Pharmacological Group Penicillins with extended spectrum + aminoglycoside (not in
ATC)
Type of Form Form 5
Pack size & Demanded Price 100ml; Decontrolled
Me-too status GENTAMOX INJECTION (100ml). Reg. No. 80160
c. Import applications of priority categories defined by Registration Board in its 257 th

meeting
i. Human
1528. Name and address of Applicant Aster Life Sciences 32-Babar Block, New Garden Town, Lahore
Detail of Drug Sale License No. 05-352-0065-013801D, valid till 29.11.2019
Address: 32-Babar Block, New Garden Town, Lahore
Name and address of Manufacturer Panacea Biotec Limited, Vill. Malpur, Baddi, Distt. Solan,
Himachal Pradesh-173205, India
Name and address of marketing M/s Panacea Biotech Ltd., Village Malpur, Baddi, Distt. Solan-
authorization holder 173205, Himachal Pradesh, India
Diary No. Date of R& I Dy No. 25111: 19.07.2018
Fee including differential fee PKR 50,000/-: 19.07.2018
Brand Name +Dosage Form + PacliAll Lyophilzed Powder for Injectable Suspension
Strength
Paclitaxel USP…..100mg
Human Albumin USP……..900mg
Pharmacological Group Taxanes
Pack size & Demanded Price
Approval status of product in ABRAXANE® for Injectable Suspension (paclitaxel protein-bound
Reference Regulatory Authorities. particles for injectable suspension, albumin-bound).
Label claim; Each single-use vial contains 100mg of paclitaxel
(bound to human albumin) and approximately 900 mg of human
albumin (containing sodium caprylate and sodium
acetyltryptophanate)
USFDA approved with box warning.
Me-too status ONCOTAXEL 100MG. Reg. No. 78156 (does not depict protein
bounding).
Detail of certificate attached  Original, legalized COPP, valid till 11.02.2020 issued by State
Drug Controller Distt. Solan Himachal Pradesh is attached.
 Original, legalized FSC, valid till 10.10.2020 issued by State
Drug Controller Distt. Solan Himachal Pradesh is attached.
 Original legalized GMP certificate valid until 11.02.2020 issued
by Health and Family Welfare Department, Himachal Pradesh
Baddi Distt. Solan is attached.
 Original legalized Sole agent letter is provided which is valid till
31.03.2021.
Remarks of the Evaluator.  It has been mentioned in the COPP, SmPC and composition that
the product contains Chloroform and Ethanol. Upon clarification,
the firm submitted that these solvents are subsequently removed
during the process. The level of these solvent in final drug
product are controlled to concentrations much below the
allowable limits as per ICH Q3C guidelines.
 The label claim of reference product is ―Each single-use vial
contains 100mg of paclitaxel (bound to human albumin) and
approximately 900mg of human albumin (containing sodium
caprylate and sodium acetyltryptophanate)‖. However, the
applied product has label claim ―Each vial contains 100 mg of
paclitaxel and 900mg of human albumin USP‖.
 In the reference product, human albumin has been stabilized by
sodium caprylate and sodium acetyltryptophanate. Clarification
was asked for such stabilization of your product. The firm
submitted that the albumin contains such stabilizing agents. The
firm submitted COA of albumin from CSL Behring, Switzerland,
mentioning sodium caprylate and sodium acetyltryptophan.
Decision: Deferred for further delibration
Evaluator PEC-XII
a. Deferred cases
1529. Name and address of manufacturer / M/s Shaigan Pharmaceuticals (Pvt) Ltd,
Applicant 14 KM Adyala Raod Post Office Daghal, Rawalpindi
Brand Name +Dosage Form + Strength Ulgin Liquid
Composition Form-5 Dy.No 5423 dated 14-02-2018 Rs. 20,000/- 14-02-2018
Diary No. Date of R& I & fee Each 10ml Contains:
Sodium Alginate…500mg
Calcium Carbonate…160mg
Type of Form Form-5
Pack size & Demanded Price 120ml/ As per SRO
Approval status of product in Gaviscon oral liquid peppermint bottle by M/s Reckitt
Reference Regulatory Authorities. Benckiser Pty Ltd, (TGA approved)
Me-too status Ul-Nil Suspension by M/s Z-Jans. (Reg# 052470)
GMP status 14-12-2017; Routine GMP Inspection
Company is found complying GMP
Remarks of the Evaluator. Evidence of Atomic absorption apparatus not submitted by firm
Decision of previous meeting of RB Deferred for confirmation of availability of atomic absorption
spectrophotometer. (M-288)
Evaluation by PEC  Firm has submitted panel inspection report dated 06-08-
2018. The report states that the quality control lab of the
firm has atomic absorption spectrophotometer. To perform
routine tests/ analysis.
Decision: Approved.
1530. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd.
Applicant 539-A, Sundar Industrial Estate,Raiwind,Lahore
Brand Name +Dosage Form + Strength Vepridone 1mg ODT Tablet
Composition Form-5 Dy.No 1055 dated 08-01-2018 Rs. 20,000 08-01-2018
Diary No. Date of R& I & fee Each Oraly Disintegrating Tablet Contains:
Risperidone…1mg
Type of Form Form-5
Pack size & Demanded Price 14‘s, 28‘s/ As per SRO
Approval status of product in RISPERDAL Quicklet 1 mg orodispersible tablets by M/s
Reference Regulatory Authorities. Janssen-Cilag Ltd (MHRA Approved)
Me-too status Wizen Flash Tablets 1mg by M/s Werrick Pharmaceuticals
(Reg#034340)
GMP status GMP dated 12-2-2018, the GMP compliance status of firm
can‘t be verified because firm was not operational at the time of
satisfactory level.
Decision of previous meeting of RB Deferred for updated status of GMP of the firm form QA & LT
division as inspection report submitted by firm does not
conclude GMP compliant status. (M-287)
2019 for GMP compliance.
The report states that panel was of opinion that the firm was
operating at satisfactory level of GMP compliance.
Decision: Approved.
Risperidone…2mg
Type of Form Form-5
Pack size & Demanded Price 14‘s, 28‘s/ As per SRO
(Reg#034341)
can‘t be verified because firm was not operational at the time of
satisfactory level.
Decision: Approved.
Risperidone…3mg
Type of Form Form-5
Pack size & Demanded Price 14‘s, 28‘s / As per SRO

(Reg#034342)
Decision: Approved.
Risperidone…4mg
Type of Form Form-5
Pack size & Demanded Price 120‘s/ As per SRO
(Reg#034343)
Decision: Approved.
1534. Name and address of manufacturer / M/s Rogen Pharmaceuticals (Pvt.) Ltd, Plot #: 30, Street No. S-
Applicant 4, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Letrogen 1mg Tablets
Composition Dy No. 30025: 06-09-2018 PKR 20,000/-: 06-09-2018
Diary No. Date of R& I & fee Each tablet contains:
Letrozole …2.5mg
Pharmacological Group Non-Steroidal aromatase inhibitor
Type of Form Form-5
Pack size & Demanded Price 10‘s, 30‘s / As per SRO
Approval status of product in FEMARA letrozole 2.5mg coated tablet by Novartis
Reference Regulatory Authorities. Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too status Femara 2.5mg Tablet by Novartis (Reg. No. 021129)
GMP status 7-9-2017 renewal of DML and grant of additional section.
Panel recommends renewal of DML & grant of additional
section.
Remarks of the Evaluator. Firm has applied as uncoated tablet whereas approved
formulation in RRA is film coated.
Decision of previous meeting of RB Deferred for revision of formulation as per reference product

formulation (M-287)
Evaluation by PEC Firm has revised formulation as per reference product along
with submission of 5,000 fee dated 01-01-2019
(Challan#0550130). The revised formulation submitted by the
firm is as:
Letrozole …2.5mg
Decision: Approved.
1535. Name and address of manufacturer / M/s Rotex Pharma (Pvt) Ltd., Plot No. 206 & 207 Industrial
Applicant triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Elpha Tablet 2mg
Composition Dy No. 8179: 10-7-2017 PKR 20,000/-: 10-07-2017
Diary No. Date of R& I & fee Each film coated tablet contains:
Melphalan (as hydrochloride)………..2mg
Pharmacological Group Alkylating agent
Type of Form Form-5
Approval status of product in Alkeran Tablet by Apotex Inc.
Me-too status Alkaran tablet by GSK
GMP status 30-03-2017: Grant of Additional Sections
Panel recommends grant of Additional Sections
Remarks of the Evaluator. ● Justify the formulation containing melphalan (as
hydrochloride) since the reference product contains
melphalan only.
● After communication of above observation vide letter no. F.1-
1/2017/PEC-DRAP dated 19-04-2018, the firm has submitted
revised Form 5 along with composition and master formulation,
details of which are as under:
―Each tablet contains:
Melphalan …… 2mg‖
Decision of previous meeting of RB Deferred for submission of fee for revision of formulation.
(M-282)
Evaluation by PEC Firm has revised formulation as per reference product along
with submission of 5,000 fee dated 29-04-2019
(Challan#1930971). The revised formulation submitted by the
firm is as:
―Each tablet contains:
Melphalan …… 2mg‖
Decision: Registration Board approved registration of product with condition that
manufacturer shall provide safety and protective measures for workers and personnel which
remain in direct contact or are involved in close handling of these drugs.
Applicant Hattar.
Contract manufactured by: M/s Weatherfold Pharmaceuticals.
Plot # 69, Phase-II, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Cypomark 2mg/35mcg Tablets
Diary No. Date of R& I & fee Form-5 Dy.No 1463 dated 10-01-2018 Rs. 50,000/- 10-01-2018
Cyproterone Acetate…2mg
Ethinyloestradiol…35mcg
Pharmacological Group Anti-androgen/ Oestrogen (Anti-Acne Preps)
Approval status of product in Co-Cyprindiol 2000/35 Coated Tablets by M/s Strandhaven
Reference Regulatory Authorities. Limited (MHRA approved)
Me-too status Diane-35 Tablets by M/s ALI GOHAR & CO (Reg#011467)
GMP status Welmark Pharmaceuticals: 04-09-2018 & 26-09-2018
Keeping in view the overall GMP compliance status of the firm,
the panel unanimously recommends the renewal of DML
Weatherfold Pharmaceuticals: Last GMP Inspection
conducted on 15-09-2017 concluded that overall the firm was
GMP compliant as per DRAP guidelines
Remarks of the Evaluator.  Firm has does not have Tablet (Hormone) section.
Decision of previous meeting of RB Deferred for evidence of approval of required manufacturing
facility of ―Tablet (Hormone) section‖ by Central Licensing
Board. (M-287)
Evaluation by PEC  Firm has submitted that it wants to revise the contract to
M/s Wnsfield Pharmaceuticals, Plot No. 122, Block-A,
Phase-V, Hattar Industrial Estate, Hattar.
 Firm has submitted contract copy (on stamp paper) between
contract giver i.e.: M/s Welmark Pharmaceuticals. And
contract acceptor M/s Wnsfield Pharmaceuticals dated 19-
12-2018.
 Products mentioned in contract are:
i. Cypomark 2mg/35mcg Tablets (Cyproterone
Acetatev+Ethinyloestradiol)
ii. Norcewel 5mg Tablet (Norethisterone Acetate)
iii. Dyfowel 10mg Tablet (Dydrogesterone)
iv. Levonorgesterel 750mcg Tablet
 M/s Wnsfield Pharmaceuticals has Tablet (Steroidal
hormone) section approved by CLB in its 267th meeting
held on 31-12-2018.
 Last GMP inspection of M/s Wnsfield Pharmaceuticals
conducted on 18-01-2018, and the report concludes that
keeping in view of overall GMP compliance, the panel
recommend the Renewal of DML.
Decision: Approved with innovator‘s specification for contract manufacturing by M/s Wnsfield
Pharmaceuticals, Hattar. The Board further advised the manufacturer to get approval for ―Tablet
(steroidal hormone) section‖ from Licensing Division before issuance of Registration letter.
Applicant Hattar
Brand Name +Dosage Form + Strength Norcewel 5mg Tablet
Norethisterone Acetate…5mg
Pharmacological Group Progestogen
Approval status of product in Norethisterone 5mg Tablets by M/s Wockhardt UK Ltd ,
Me-too status Feminor 5mg tablet by M/s Wilson (Reg#011160)
Board. (M-287)

12-2018.
held on 31-12-2018.
Decision: Approved with BP specification for contract manufacturing by M/s Wnsfield
Applicant Hattar
Brand Name +Dosage Form + Strength Dyfowel 10mg Tablet
Dydrogesterone…10mg
Pharmacological Group Progestogen
Approval status of product in Duphaston 10 mg film-coated tablet by M/s Mylan Medical
Reference Regulatory Authorities. SAS , (ANSM approved)
Me-too status Duphaston 10 mg tablet by M/s Abbott(Reg#006654)
Board. (M-287)
12-2018.
held on 31-12-2018.
Decision: Approved with BP specification for contract manufacturing by M/s Wnsfield
1539. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd,
Applicant 30-km, Multan Road, Lahore.
Brand Name +Dosage Form + Strength Exestane 25mg Tablets
Diary No. Date of R& I & fee Diary No:10938, 26/03/2018, Rs. 20,000/-
Exemestane…25mg
Pharmacological Group Aromatase inhibitors (Steroidal)
Pack size & Demanded Price 3x5‘s/ As per SRO
Approval status of product in Aromasin 25 mg coated tablets by M/s Pfizer Limited
Me-too status Ph&T Exemestane 25mg Coated Tablets by M/s Mehran
International (Reg#078122)
GMP status 07-11-2017. Panel recommends grant of Additional sections
Decision of previous meeting of RB The Board deferred product and advised the firm to get
approval from Licensing Division particularly for either Tablet
(Steroidal Hormone) or Tablet (Non-steroidal Hormone) for
further processing by Registration Board. (M-281)
Deferred for clarification whether the applied product is
hormone or otherwise. (M-286)
Evaluation by PEC  Firm has submitted that the applied product is steroidal
aromatase inhibitor and it was confirmed as well.
Decision: Deferred for confirmation of concerned section
1540. Name and address of manufacturer / M/s Zamko Pharmaceuticals (Pvt) Ltd.
Applicant 641-A Sundar Industrial Estate, Lahore .
Brand Name +Dosage Form + Strength Mycin 250mg/5ml Dry Suspension
Diary No. Date of R& I & fee Form-5 Dy.No 3535 dated 24-01-2019 Rs.20,000/- 25-01-2019
Fosfomycin Calcium…250mg
Pharmacological Group Other antibacterials
Pack size & Demanded Price 60ml / As per SRO
Approval status of product in FOSFOCINA Suspension 250mg/5ml by M/s
Reference Regulatory Authorities. LABORATORIOS ERN, S.A. Barcelona, España (Spain
Approved)
Me-too status Fosfonex 250mg/5ml Suspension of M/s Nexus Pharma
(Reg#075836)
GMP status 13-04-2018; Grant of DML Panel recommends Grant of DML
Remarks of the Evaluator. Firm has applied as Fosfomycin Calcium…250mg, whereas,
formulation approved in Spain is Fosfomycin (as
Calcium)…250mg
Decision of previous meeting of RB Deferred for revision of salt forms of the API in the formulation
as per the reference product along with submission of fee for
revision of formulation. (M-288)
Evaluation by PEC  Firm has revised the formulation as follows:

Each 5ml Contains:
Fosfomycin (as calcium) …250mg
Alongwith form 5 and master formulation
 Firm has submitted fee challan of Rs.5,000/-
(Challan#812309) Dated 11-02-2019
Decision: Approved.
1541. Name and address of manufacturer / M/s Zamko Pharmaceuticals (Pvt) Ltd.
Applicant 641-A Sundar Industrial Estate, Lahore .
Brand Name +Dosage Form + Strength Zambin 500mcg Tablet
Diary No. Date of R& I & fee Form-5 Dy.No 3528 dated 24-01-2019 Rs.20,000/- 25-01-2019
Composition Each film Coated Tablet Contains:
Approval status of product in Methicobide tablet 500 mcg sugar-coated, by Daito
Reference Regulatory Authorities. Corporation. Approved by PMDA Japan
Me-too status Elgin 500 mcg tablet of M/s Novartis Pharma (Pvt)
Limited (Reg. # 032638)
GMP status 13-04-2018; Grant of DML.Panel recommends Grant of DML
Remarks of the Evaluator.  Firm has applied as film coated tablet whereas formulation
approved in PMDA is sugar coated.
Decision of previous meeting of RB Deferred for submission of evidence of approval of applied
formulation as ―film coated tablets‖ in reference regulatory
authorities/agencies which were adopted by the Registration
Board in its 275th meeting or else the formulation may be
revised in accordance with reference product along with
submission of requisite fee. (M-288)
Evaluation by PEC  Firm has revised the formulation as follows:
Each sugar Coated Tablet Contains:
Alongwith form 5 and master formulation
 Firm has submitted fee challan of Rs. 5000/-
(Challan#817188) Dated 11-02-2019
Decision: Approved.
Case No. 02: Registration Applications of Newly Granted DML or New Section (Human).
a. New DML
M/s Cure Laboratories (Pvt) Ltd., Rawalpindi (New Licence)
CLB in its 269th meeting held on 26th Feb 2019 has considered and granted the Drug Manufacturing License
(DML) to M/s Cure Laboratories (Pvt) Ltd by way of formulation and granted (03) new section to the firm.
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Sr.No Section No. of Products No of Molecules
1 Capsule Section (Cephalosporin) 17 09
2 Dry Powder Suspension (Cephalosporin) Section 19 10
3 Dry Powder Vial (Sterile) (Cephalosporin) Section 36 10
Cephalosporin Capsule Section
1542. Name and address of Manufacturer / M/s Cure Laboratories (Pvt) Ltd., Plot No. 11&12, Street No.
Applicant NS-2 National Industrial Zone, Rawat Rawalpindi.
Brand Name + Dosage Form + Strength Caflor 250mg Capsule
Cefaclor (as monohydrate)....250mg
Diary No, Date of R & I & fee Dy.No 11187 dated 05-03-2019 Rs.20,000/- Dated 04-03-2019
Pharmacological Group 2nd Generation Cephalosporin
Type of Form Form-5
Pack Size & Demanded Price 12‘s /As per SRO
Approval Status of product in Reference Cefaclor 250mg Capsules by M/s Ranbaxy (UK) Limited
Me-too status Faceclor 250mg Capsule by M/s City Karachi (Reg#070600)
GMP Status 19-02-2019 &22-02-2019 Grant of DML Panel unanimously
recommended grant of DML
Decision: Approved.
1543. Name and address of Manufacturer / M/s Cure Laboratories (Pvt) Ltd.Plot No. 11&12, Street No.
Applicant NS-2 National Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength Caflor 500mg Capsule
Cefaclor (as monohydrate)...500mg
Type of Form Form-5
Approval Status of product in Reference Cefaclor Capsules 500mg by M/s Strides Pharma UK Ltd
Me-too status Faceclor 500mg Capsule by M/s City Karachi (Reg#070601)
Decision: Approved.
Brand Name + Dosage Form + Strength Roxikef 250mg Capsule
Cefadroxil (as monohydrate).....250mg
Type of Form Form-5
Pack Size & Demanded Price 12s, As per SRO
Approval Status of product in Reference Not confirmed
Me-too status Oradrox Capsules 250mg M/s Biorex Pharmaceutical
(Reg#031876)
Remarks of the Evaluator  Approval Status of product in Reference Regulatory
Authorities not confirmed.
1545. Name and address of Manufacturer / M/s Cure Laboratories (Pvt) Ltd, Plot No. 11&12, Street No.
Type of Form Form-5
Approval Status of product in Reference Cefadroxil 500 mg capsules, hard by M/s Alkaloid-INT d.o.o.
Me-too status Evacef 500mg Capsules by M/s Highnoon Laboratories
(Reg#009141)
Decision: Approved.
Type of Form Form-5
Pack Size & Demanded Price 12s , As per SRO
Me-too status Safedroxil 1g Capsule M/s Safe Pharmaceuticals (Reg#048856)
1547. Name and address of Manufacturer / M/s Cure Laboratories (Pvt) Ltd., Plot No. 11&12, Street
Applicant No. NS-2 National Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength Poxime 100mg Capsule
Cefpodoxime (as proxetil)…100mg
Type of Form Form-5
Pack Size & Demanded Price 12s / As per SRO
Me-too status Qink Capsules 100mg M/s Wilshire (Reg#036255)
 Master formulation submitted by the firm is of another
product.
 Submission of master formulation for applied product.
Brand Name + Dosage Form + Strength Fixikef 200mg Capsule
Cefixime (as trihydrate).....200mg
Type of Form Form-5
Pack Size & Demanded Price 5s , As per SRO
Approval Status of product in Reference Spain approved
Me-too status Cefix Capsules 200mg M/s Biosynth (Reg#030249)
Decision: Approved.
Brand Name + Dosage Form + Strength Fixikef 400mg Capsule
Cefixime (as trihydrate).....400mg
Type of Form Form-5
Approval Status of product in Reference Suprax 400 mg capsules by Lupin Pharma (USFDA Approved)
Me-too status Cefiget Capsule 400 mg by Getz Pharma (Reg#045118)
Decision: Approved.
Brand Name + Dosage Form + Strength Velofex 250mg Capsule
Cephradine....250mg
Pharmacological Group 1st Generation Cephalosporin
Type of Form Form-5
Approval Status of product in Reference Cefradine 250mg Capsules by M/s Athlone Pharmaceuticals
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)
Decision: Approved.
Brand Name + Dosage Form + Strength Velofex 500mg Capsule
Cephradine.....500mg
Type of Form Form-5
Approval Status of product in Reference Cefradine 500mg Capsules by M/s Athlone Pharmaceuticals
Me-too status Dinar 500mg capsule byM/s Baxter Pharma (Reg#084548)
Decision: Approved.
th
Brand Name + Dosage Form + Strength Rinidef 100mg Capsule
Cefdinir…100mg
Pharmacological Group 3rd Generation Cephalosporin
Type of Form Form-5
Pack Size & Demanded Price 6s /, As per SRO
Approval Status of product in Reference Cefzon capsule 100 mg by M/s Astellas Pharma Inc.
Regulatory Authorities. (PMDA Japan Approved)
Me-too status Cefnir 100mg Capsule by M/s Barret Hodgson (Reg#023931)
Decision: Approved.
Brand Name + Dosage Form + Strength Rinidef 300mg Capsule
Cefdinir…300mg
Type of Form Form-5
Pack Size & Demanded Price 6‘s, /As per SRO
Approval Status of product in Reference Cefdinir 300mg Capsule by M/s Sandoz (USFDA approved)
Me-too status Zaply 300mg capsule by Wilshire/Horizon (Reg#053638)
Decision: Approved.
Brand Name + Dosage Form + Strength Curakef 250mg Capsule
Cephalexin (as monohydrate).....250mg
Type of Form Form-5
Pack Size & Demanded Price 2x6‘s /As per SRO
Approval Status of product in Reference Cefalexin 250 mg Capsules, HARD by M/s Athlone
Regulatory Authorities. Pharmaceuticals Limited (MHRA Approved)
Me-too status Xtab-250 Capsule by M/s Wellborne Pharmachem and
biological (Reg#081747)
Decision: Approved.
Brand Name + Dosage Form + Strength Curakef 500mg Capsule
Cephalexin (as monohydrate)…500mg
Type of Form Form-5
Approval Status of product in Reference Cefalexin 500 mg Capsules by M/s Alkem Pharma GmbH
Me-too status Ceporex 500mg Capsule by M/s GSK (Reg#005641)
Decision: Approved.
Brand Name + Dosage Form + Strength Oxicure 250mg Capsule
Cefuroxime (as axetil) ...250mg
Type of Form Form-5
Pack Size & Demanded Price 12s /As per SRO
Me-too status Trucef capsule by M/s Synchro Pharma (Reg#048978)
Brand Name + Dosage Form + Strength Oxicure 500mg Capsule
Cefuroxime (as axetil) ...500mg
Type of Form Form-5
Pack Size & Demanded Price 12s /, As per SRO
Me-too status Trucef capsule by M/s Synchro Pharma (Reg#048978)
 Master formulation submitted by the firm is of another
product.
 Submission of master formulation for applied product.
Brand Name + Dosage Form + Strength Bitafen 400mg Capsule
Ceftibuten (as dihydrate)…400mg
Type of Form Form-5
Finished Product Specification Innovator's specifications
Pack Size & Demanded Price 5‘s, /As per SRO
Approval Status of product in Reference ISOCEF 400 mg capsule by M/s RECORDATI Chemical
Regulatory Authorities. Industry and Pharmaceutical S.p.A. (Italy Approved)
Me-too status Xigris 400mg capsule by Wilshire/Horizon (Reg#053635)
Dry Powder Suspension (Cephalosporin) Section
Brand Name + Dosage Form + Strength Caflor 125mg/5ml Dry Suspension
Composition Each 5 ml after reconstitution contains:
Cefaclor (as monohydrate)…250mg
Type of Form Form-5
Pack Size & Demanded Price 60ml /As per SRO
Approval Status of product in Reference Cefaclor 250mg/5ml Suspension by M/s Strides Pharma UK
Regulatory Authorities. Ltd (MHRA approved)
Me-too status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081618)
GMP Status Grant of DML
Remarks of the Evaluator 19-02-2019 &22-02-2019
Grant of DML.Panel unanimously recommended grant of DML
Decision: Approved.
Brand Name + Dosage Form + Strength Caflor 250mg/5ml Dry Suspension
Cefaclor (as monohydrate)…250mg
Type of Form Form-5
Approval Status of product in Reference Cefaclor 250mg/5ml Suspension by M/s Strides Pharma UK
Regulatory Authorities. Ltd (MHRA approved)
Me-too status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos Pharma
(Reg#081618)
Decision: Approved.
Brand Name + Dosage Form + Strength Roxikef 125mg/5ml Dry Suspension
Cefadroxil (as monohydrate)…125mg
Type of Form Form-5
Approval Status of product in Reference ORACEFAL 125 mg / 5 ml powder for oral suspension by M/s
Regulatory Authorities. Bristol - Myers Squibb (ANSM Approved)
Me-too status Evacef Suspension 125mg/5ml by M/s Highnoon Laboratories,
Lahore (Reg#011213)
Decision: Approved.
Brand Name + Dosage Form + Strength Roxikef 250mg/5ml Dry Suspension
Cefadroxil (as monohydrate)…250mg
Type of Form Form-5
Approval Status of product in Reference Duricef 250mg/5ml by M/s Warner Chilcott , (USFDA
Regulatory Authorities. Approved)
Me-too status Evacef Suspension 250mg/5ml by M/s Highnoon Laboratories,
Lahore (Reg#011214)
Decision: Approved.
Brand Name + Dosage Form + Strength Rinidef 125mg/5ml Dry Suspension
Cefdinir…125mg
Type of Form Form-5
Approval Status of product in Reference Cefdinir 125mg/5ml powder for Suspension by M/s Lupin
Regulatory Authorities. LTD (USFDA approved)
Me-too status Zefnir 125mg/5ml dry Suspension by M/s Genome
Pharmaceuticals (Reg. No. 075525)
Decision: Approved.
Brand Name + Dosage Form + Strength Rinidef 250mg/5ml Dry Suspension
Cefdinir…250mg
Type of Form Form-5
Approval Status of product in Reference Cefdinir 250mg/5ml powder for Suspension by M/s Lupin
Regulatory Authorities. LTD (USFDA approved)
Me-too status Zefnir 250mg/5ml dry Suspension by M/s Genome
Decision: Approved.
Brand Name + Dosage Form + Strength Fixikef 100mg/5ml Dry Suspension
Cefixime (as trihydrate)…100mg
Type of Form Form-5
Pack Size & Demanded Price 30ml, /As per SRO
Approval Status of product in Reference Cefixime 100 mg/5 ml Powder for Oral Suspension by M/s
Regulatory Authorities. Generics [UK] Ltd t/a Mylan (MHRA Approved)
Me-too status Stlicef dry suspension 100mg/5ml by M/s Treat Pharma
(Reg#073247)
Decision: Approved.
Brand Name + Dosage Form + Strength Fixikef 200mg/5ml Dry Suspension
Cefixime (as trihydrate)…200mg
Type of Form Form-5
Pack Size & Demanded Price 30ml/As per SRO
Approval Status of product in Reference Cefixime for oral suspension 200mg/5ml by M/s Aurobindo
Regulatory Authorities. Pharma (USFDA approved)
Me-too status Biozil Dry Suspension 200mg/5ml by M/s Biolabs
(Reg#054770)
Decision: Approved.
Brand Name + Dosage Form + Strength Poxime 40mg/5ml Dry Suspension
Type of Form Form-5
Approval Status of product in Reference Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension
Regulatory Authorities. by M/s Sandoz GMBH, MHRA approved
Me-too status Apodox Dry Suspension by M/s Alliance (Reg#054697)
Decision: Approved.
Brand Name + Dosage Form + Strength Poxime 80mg/5ml Dry Suspension
Type of Form Form-5
Me-too status Cefporite 80 mg/5ml DS Dry Suspension
M/s Sharooq Pharmaceuticals (Reg#069443)
Brand Name + Dosage Form + Strength Zilacure 125mg/5ml Dry Suspension
Type of Form Form-5
Approval Status of product in Reference Cefprozil powder for suspension 125mg/5ml by M/s Aurobindo
Regulatory Authorities. Pharma USA, Inc. (USFDA approved)
Me-too status Vegapro 125mg/5ml dry powder for Suspension by M/s Vega
Decision: Approved.
Brand Name + Dosage Form + Strength Zilacure 250mg/5ml Dry Suspension
Type of Form Form-5
Approval Status of product in Reference Cefprozil powder for suspension 250mg/5ml by M/s Aurobindo
Regulatory Authorities. Pharma USA, Inc. (USFDA approved)
Me-too status Vegapro 250mg/5ml dry powder for Suspension by M/s Vega
Decision: Approved.
Brand Name + Dosage Form + Strength Oxicure 125mg/5ml Dry Suspension
Cefuroxime (as axetil)…125mg
Type of Form Form-5
Approval Status of product in Reference Zinnat Suspension 125mg/5ml by M/s Glaxo Wellcome UK
Me-too status Kefrox Suspension of M/s CCL Pharmaceuticals (Reg.#
026054)
Decision: Approved.
Brand Name + Dosage Form + Strength Oxicure 250mg/5ml Dry Suspension
Cefuroxime (as axetil) …250 mg
Type of Form Form-5
Pack Size & Demanded Price 50ml (after reconstitution), As per SRO
Approval Status of product in Reference ZINNAT cefuroxime (as axetil) 250 mg/5mL granules for oral
Regulatory Authorities. suspension by M/s Aspen Pharmacare Australia Pty Ltd (TGA
Approved)
Me-too status Optik 250mg/5ml DS Dry Suspension M/s Wilshire
Laboratories (Pvt) Ltd. (Reg#053644)
Decision: Approved.
Brand Name + Dosage Form + Strength Curakef 125mg/5ml Dry Suspension
Type of Form Form-5
Approval Status of product in Reference Cefalexin 125mg/5ml Powder for Oral Suspension by M/s
Regulatory Authorities. Milpharm Limited (MHRA approved)
Me-too status Vegzin 125mg/5ml by M/s Vega Pharmaceuticals (R#078699)
Decision: Approved.
Brand Name + Dosage Form + Strength Curakef 250mg/5ml Dry Suspension
Type of Form Form-5
Approval Status of product in Reference Cefalexin 250mg/5ml Powder for Oral Suspension by M/s
Regulatory Authorities. Milpharm Limited (MHRA approved)
Me-too status Vegzin 250mg/5ml by M/s Vega Pharmaceuticals (R#078700)
Decision: Approved.
Brand Name + Dosage Form + Strength Velofex 125mg/5ml Dry Suspension
Cephradine…125mg
Type of Form Form-5
Pack Size & Demanded Price 60ml, 90ml /As per SRO
Me-too status Licef Dry Powder Susp.125mg/5ml by M/s Wisdom (R#078532)
Remarks of the Evaluator  Approval status of product in Reference Regulatory
Brand Name + Dosage Form + Strength Velofex 250mg/5ml Dry Suspension
Cephradine…250mg
Type of Form Form-5
Approval Status of product in Reference Cefradine 250mg/5ml dry powder for syrup by M/s Strides
Regulatory Authorities. Pharma UK Ltd (MHRA Approved)
Me-too status Licef Dry Powder suspension 250mg/5ml by M/s Wisdom
Pharmaceuticals (Reg#078531)
Decision: Approved.
Brand Name + Dosage Form + Strength Bitafen 90mg/5ml Dry Suspension
Ceftibuten (as dihydrate)…90mg
Type of Form Form-5
Finished Product Specification Innovator's specifications
Approval Status of product in Reference CEDAX 90mg/5ml Dry Suspension by M/s Shionogi USA, Inc
Me-too status Xigris 90mg/5ml Dry Suspension by Wilshire/Horizon
(R#053634)
Dry Powder Vial (Sterile) (Cephalosporin) Section
Brand Name + Dosage Form + Strength Fepime 500mg Injection
Cefepime (as hydrochloride)…500mg
With L-Arginine
Pharmacological Group 4th Generation Cephalosporin
Type of Form Form-5
Approval Status of product in Reference Cefipime hydrochloride 500mg Injection by M/s Hospira, Inc.
Me-too status Uspime 500mg Injection by Usawa Pharma (R#060251)
Decision: Approved.
Cefepime (as hydrochloride)…1 gm
With L-Arginine
Type of Form Form-5
Approval Status of product in Reference Cefipime hydrochloride 1gm Injection by M/s Hospira, Inc.
Me-too status Uspime 500mg Injection by Usawa Pharma (R# 060250)
Decision: Approved.
Cefepime (as hydrochloride)…2gm
With L-Ariginine
Type of Form Form-5
Approval Status of product in Reference Cefipime hydrochloride 2g Injection by M/s Hospira, Inc.
Me-too status Pimax Injection 2g by M/s Hilton Pharma (Reg#042114)
Decision: Approved.
Brand Name + Dosage Form + Strength Niacef 250mg Injection IV
Ceftriaxone (as sodium)…250mg
Type of Form Form-5
Approval Status of product in Reference Rocephin IV 250 mg Powder and Solvent for Solution for
Regulatory Authorities. Injection by M/s Roche Products Ltd (MHRA Approved)
Me-too status Trixone 250mg IV Injection by M/s Aptcure (Pvt) Ltd
(Reg#085225)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference Rocephin IV 500 mg Powder and Solvent for Solution for
Me-too status Signum 500 mg Injection I.V by M/s Cherwel Pharmaceuticals
(Pvt) Ltd (Reg#079307)
Decision: Approved.
Ceftriaxone (as sodium)…1gm
Type of Form Form-5
Approval Status of product in Reference Rocephin IV 1 g powder and solvent for solution for injection
Regulatory Authorities. by M/s Roche Products Ltd (MHRA Approved)
Me-too status Signum 1 gm Injection I.V. by M/s Cherwel Pharmaceuticals
(Pvt) Ltd (Reg#079308)
Decision: Approved.
Ceftriaxone (as sodium)…2 grams
Type of Form Form-5
Approval Status of product in Reference Rocephin IV Injection 2gm By M/s Roche Products Limited
Regulatory Authorities. (MHRA approved)
Me-too status Titan 2gm IV Injection by M/S Macter Pharma (Reg No.
075825)
Decision: Approved.
Brand Name + Dosage Form + Strength Niacef 250mg Injection IM
Type of Form Form-5
Approval Status of product in Reference Rocephin IM 250 mg Powder and Solvent for Solution for
Me-too status Ceftiheim Injection IM 250mg by M/s Pakheim International
Pharma (Pvt) Ltd (Reg#085193)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference Rocephin IM 500 mg Powder and Solvent for Solution for
Me-too status Rocimed 500mg Injection I.M by M/s Medicraft
Pharmaceuticals (Pvt) Ltd (Reg#082030)
Decision: Approved.
Ceftriaxone (as sodium)…1gram
Type of Form Form-5
Approval Status of product in Reference Rocephin IM 1 g powder and solvent for solution for injection
Regulatory Authorities. by M/s Roche Products Ltd (MHRA Approved)
Me-too status Lozone Injectin I.M 1gm by M/s Llyods Pharma (R#027052)
Decision: Approved.
Brand Name + Dosage Form + Strength Ricef 250mg Injection
Cefoperazone (as sodium)…500mg
Type of Form Form-5
Approval Status of product in Reference Cefobid 250mg Powder and solvent for solution injection for
Regulatory Authorities. intramuscular Use by M/s Pfizer Italia SRL (AIFA Italy
Approved)
Me-too status CEFOBID Injection 0.25gm by M/s PFIZER (Reg#020651)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference Cefobid 500mg Powder and solvent for solution injection for
Regulatory Authorities. intramuscular Use by M/s Pfizer Italia SRL (AIFA Italy
Approved)
Me-too status CEFOBID Injection 0.5gm by M/s PFIZER (Reg#013841)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference CEFOBID 1g/3ml powder and solvent for solution for injection
Regulatory Authorities. for intramuscular use by M/s Pfizer Italia SRL (AIFA Italy
Approved)
Me-too status CEFOBID Injection 1gm by M/s PFIZER (Reg#008524)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference CEFOBID 2 g powder for solution for injection for intravenous
Regulatory Authorities. use by M/s Pfizer Italia SRL (AIFA Italy Approved)
Me-too status CEFOBID Injection 2gm by M/s PFIZER (Reg#013842)
Decision: Approved.
Brand Name + Dosage Form + Strength Mitrox 250mg Injection
Ceftizoxime…………….250mg
Type of Form Form-5
Approval Status of product in Reference Not confirmed.
Me-too status Tezox 250mg Injection M/s Bosch Pharmaceuticals (Pvt.) Ltd
(Reg#034859)
Type of Form Form-5
Me-too status Tezox 500mg Injection M/s Bosch Pharma (Reg#034852)
Type of Form Form-5
Me-too status Tezox 1000mg Injection M/s Bosch Pharmaceuticals (Pvt.) Ltd
(Reg#034853)
Brand Name + Dosage Form + Strength Oxicure 250mg Injection
Cefuroxime (as sodium)…250mg
Type of Form Form-5
Approval Status of product in Reference Cefuroxime 250 mg powder for solution for injection by M/s
Regulatory Authorities. Stragen UK Limited (MHRA Approved)
Me-too status ZINACEF 250MG INJ by M/s GSK Pakistan (Reg#006221)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference Curoxim 500 mg powder and solvent for suspension for
Regulatory Authorities. injection by M/s GlaxoSmithKline S.p.A. (AIFA Italy
Approved)
Me-too status Optik 500mg Injection M/s 'Wilshire (Reg#071388)
Decision: Approved.
Type of Form Form-5
Pack Size & Demanded Price 1‘s/As per SRO
Approval Status of product in Reference Cefuroxime 750 mg powder for solution for injection by M/s
Regulatory Authorities. MIP Pharma GmbH (MHRA Approved)
Me-too status ZINACEF 750MG INJ by M/s GSK Pakistan (Reg#006222)
Decision: Approved.
Cefuroxime (as sodium)…1.5gm
Type of Form Form-5
Approval Status of product in Reference Cefuroxime 1.5 g powder for solution for injection/infusion by
Regulatory Authorities. M/s Stragen UK Limited (MHRA Approved)
Me-too status Zecef Injection 1.5gm by M/s
Bosch Pharmaceuticals (Pvt) Ltd, (Reg#026898)
Decision: Approved.
Brand Name + Dosage Form + Strength Ricef Plus 250mg Injection
Cefoperazone (as sodium)....125mg
Sulbactam (as sodium)....125mg
Pharmacological Group 3rd Generation Cephalosporin + Beta Lactamase Inhibitor
Type of Form Form-5
Me-too status Not confirmed.
 Me-too status not confirmed from available database.
which were adopted by the Registration Board in its 275th meeting.
Type of Form Form-5
Approval Status of product in Reference PMDA Japan Approved
Me-too status 2Sum Injection 500mg of M/s Sami Pharmaceuticals,
Karachi (Reg.# 079941)
Decision: Approved.
Type of Form Form-5
Approval Status of product in Reference PMDA Japan Approved
Me-too status Cebac Injection 1gm by M/s Bosch (Reg#037630)
Decision: Approved.
Cefoperazone (as sodium)…1 gram
Sulbactam (as sodium)…1 gram
Type of Form Form-5
Approval Status of product in Reference Approved in Europe (Poland, Slovakia, Czech
Regulatory Authorities. Republic) by EMA
Me-too status Cebac Injection 2gm by M/s Bosch (Reg#037631)
Decision: Approved.
Brand Name + Dosage Form + Strength P-Rome 500mg Injection
Cefpirome (as sulphate) ....500mg
Pharmacological Group 4th generation cephalosporin
Type of Form Form-5
Approval Status of product in Reference Cefrom 0.5 g powder for solution for injection (IV) by M/s
Regulatory Authorities. Sanofi Aventis France (ANSM Approved)
Me-too status Cefrom Injection 0.5gm by M/s Sanofi Aventis (Reg#021123)
Brand Name + Dosage Form + Strength P-Rome 1000mg Injection
Cefpirome (as sulphate) ....1000mg
Pharmacological Group 4th generation cephalosporin
Type of Form Form-5
Pack Size & Demanded Price 1‘s / As per SRO
Approval Status of product in Reference Cefrom 1 g powder for solution for injection (IV) by M/s
Regulatory Authorities. Sanofi Aventis France (ANSM Approved)
Me-too status Cefrom Injection 1gm by M/s Sanofi Aventis (Reg#021124)
Brand Name + Dosage Form + Strength C-Taz 250mg Injection
Ceftazidime (as pentahydrate)…250mg
Type of Form Form-5
Approval Status of product in Reference Fortum 250 mg powder for solution for injection by M/s
Regulatory Authorities. GlaxoSmithKline UK (MHRA Approved)
Me-too status Panacef Injection 250mg by M/s CCL (Reg# 023858)
GMP Status 19-02-2019 &22-02-2019
Grant of DML
Panel unanimously recommended grant of DML
Decision: Approved.
Ceftazidime (as pentahydrate)…500mg
Type of Form Form-5
Approval Status of product in Reference Fortum 500 mg powder for solution for injection by M/s
Me-too status Panacef Injection 500mg by M/s CCL (Reg# 023859)
Decision: Approved.
Ceftazidime (as pentahydrate)…1gm
Type of Form Form-5
Approval Status of product in Reference Fortum 1g powder for solution for injection by M/s
Me-too status Panacef Injection 1gm by M/s CCL (Reg# 023986)
Decision: Approved.
Brand Name + Dosage Form + Strength Dimax 250mg Injection
Cefotaxime (as sodium)....250mg
Type of Form Form-5
Cefotaxime (as sodium)....500mg
Type of Form Form-5
Cefotaxime (as sodium)....1gm
Type of Form Form-5
Approval Status of product in Reference Claforan Injection 1gm by M/s Aventis Pharma Limited
Me-too status Getex Dry powder Injection 1gm by M/s Amarant from
Brand Name + Dosage Form + Strength Cefazol 250mg Injection
Cefazolin (as sodium)…250mg
Type of Form Form-5
Approval Status of product in Reference CEFAMEZIN 250 mg / 2 ml powder and solvent for solution
Regulatory Authorities. for injection for intramuscular use by M/s PFIZER ITALIA
S.r.l (AIFA Italy Approved)
Me-too status Cefamezin 250mg injection by M/s Barrett Hodgson
(Reg#008126)
Decision: Approved.
Cefazolin (as sodium)…500mg
Type of Form Form-5
Approval Status of product in Reference Cefazolin For Injection 500mg by M/s Sandoz (USFDA
Me-too status Safelin Injection 500mg by M/s Fassgen Pharmaceuticals
(Reg#074512)
Decision: Approved.
Cefazolin (as sodium)…1g
Type of Form Form-5
Approval Status of product in Reference Cefazolin For Injection 1g by M/s Sandoz (USFDA Approved)
Me-too status Safelin Injection 1 gm by M/s Fassgen Pharma(Reg#074513)

Decision: Approved.
M/s Greater Pharma Rawat Rawalpindi (New Licence)
CLB in its 269th meeting held on 26th Feb 2019 has considered and granted the Drug Manufacturing License
(DML) to M/s Greater Pharma by way of formulation and granted (04) new section to the firm. Accordingly,
firm has applied for following products for consideration by Drug Registration Board.
Sr.No Section No. of Molecules No of Products
1 Cream/Ointment section (General) 09 10
2 Topical Lotion Section (General) 08 08
3 Capsule Section (General) 10 13
4 Cream/Ointment Section (Steroid) 07 07
5 Topical Lotion Section (Steroid) 02 02
Cream/Ointment section (General)
1614. Name and address of Manufacturer / Greater Pharma. Plot No 35,Street No SS-3, RCCI Industrial
Applicant Estate, Rawat Rawalpindi.
Brand Name + Dosage Form + Strength Adben Gel
Composition Each gram contains
Adapalene …1 mg (0.1%w/w)
Benzoyl peroxide …25 mg (2.5%w/w)
Type of Form Form-5
Pack Size & Demanded Price 10 g, 15 g, 30 g /As per SRO
Approval Status of product in Reference Epiduo 0.1% / 2.5% gel by M/s Galderma (UK) Ltd (MHRA
Me-too status Adalen e-B Gel by Pharmatec (Reg#076683)
GMP Status 20-12-2017 Panel recommends grant of DML.
Remarks of the Evaluator  Firm does not have manufacturing facility to manufacture
applied product.
Decision: Deferred for evidence of required manufacturing facility for applied formulation since
firm has approved section for Cream/Ointment (general) whereas applied formulation is a gel.
Brand Name + Dosage Form + Strength Calciget Ointment 0.005 %w/w
Composition Each gram of Ointment tube contains
Calcipotriol … 50 mcg (0.005%w/w)
Type of Form Form-5
Pack Size & Demanded Price 30 g /As per SRO
Approval Status of product in Reference Calcipotriol Ointment 50micrograms/g by M/s Sandoz
Me-too status Dervit Ointment 0.005%w/w by M/s Nabiqasim (R#067444 )
Decision: Approved.
Brand Name + Dosage Form + Strength Calcin-B Gel
Composition Each gram of tube contains
Clindamycin (as phosphate) …10 mg (1%w/w)
Benzoyl peroxide …50 mg (5%w/w)
Pharmacological Group Anti-infectives for treatment of acne
Type of Form Form-5
Pack Size & Demanded Price 10,15 & 25 g /As per SRO
Approval Status of product in Reference Duac Once Daily 10mg/g + 50mg/g Gel by M/s
Regulatory Authorities. GlaxoSmithKline UK Limited (MHRA Approved)
Me-too status Clingard- Gel by M/s Hoover Pharmaceuticals (Reg#064533)
applied product.
Brand Name + Dosage Form + Strength Clacin Gel 1%w/w
Clindamycin (as phosphate) …................10 mg (1%w/w)
Type of Form Form-5
Pack Size & Demanded Price 10g /As per SRO
Approval Status of product in Reference RESIDERM 1%w/w GEL by M/s Crawford Healthcare
Me-too status Clindacin Gel 1%w/w by M/s Sante (Reg#067485)
applied product.
Brand Name + Dosage Form + Strength Clacin-V Cream 2%w/w
Clindamycin (as phosphate) …20 mg (2%w/w)
Type of Form Form-5
Approval Status of product in Reference Dalacin Cream 2%w/w By M/s Pfizer Ltd (MHRA Approved)
Me-too status Clinzen Cream 2%w/w by M/s Shrooq (Reg#040844 )
Decision: Approved.
Brand Name + Dosage Form + Strength Isogel-E Gel 0.5/20 mg
Isotretinoin …0.5mg (0.05%w/w)
Erythromycin …20mg (2%w/w)
Pharmacological Group Retinoids and antiinfectives for topical use in acne
Type of Form Form-5
Approval Status of product in Reference Isotrexin Gel by M/s GlaxoSmithKline UK Limited (MHRA
Me-too status Isogyl Gel of Noa Hemis (Reg#080623)
applied product.
Brand Name + Dosage Form + Strength Renac Gel 2.5 %w/w
Ketoprofen ….......................25mg (2.5 %w/w)
Pharmacological Group Antiinflammatory preparations, non-steroids for topical use
Type of Form Form-5
Pack Size & Demanded Price 25g, 30g /As per SRO
Approval Status of product in Reference Fastum 2.5% gel by M/s A Menarini Industrie Fa
Regulatory Authorities. rmaceutiche Ruinite srl (MHRA Approved)
Me-too status Ticon 2.5 % w/w Gel of M/s Amarant, Karachi
(Reg.# 070499)
applied product.
Brand Name + Dosage Form + Strength Trago Cream 2%w/w
Mupirocin (as calcium dihydrate) …20mg (2%w/w)
Pharmacological Group Other antibiotics for topical use
Type of Form Form-5
Approval Status of product in Reference Bactroban 2% cream by M/s GlaxoSmithKline (USFDA
Me-too status Mupiderm 2% Cream by M/s Tabros (Reg#070685)
Decision: Approved.
Brand Name + Dosage Form + Strength Trico Ointment 0.1 %w/w
Tacrolimus (as monohydrate) …1mg
Pharmacological Group Agents for dermatitis, excluding corticosteroids
Type of Form Form-5
Approval Status of product in Reference Protopic 0.1% w/w ointment by M/s Astellas Ireland Co. Ltd
Regulatory Authorities. (Netherlands Approved),
Me-too status Eczemus 0.1% Ointment by M/s Brookes Pharma
(Reg#045493)
Brand Name + Dosage Form + Strength Terbiget Cream 1%w/w
Terbinafine hydrochloride ...10 mg (1%w/w)
Type of Form Form-5
Pack Size & Demanded Price 10g, 15g /As per SRO
Approval Status of product in Reference Terbinafine Hydrochloride 1 % Cream By M/s Generics [UK]
Regulatory Authorities. Limited t/a Mylan (MHRA Approved)
Me-too status Bina 1.0% Cream by M/s Linta pharmaceuticals (Pvt) Limited ,
Islamabad (Reg.# 080268)
Topical Lotion Section (General)
Brand Name + Dosage Form + Strength Hairget Solution 5 %w/v
Composition Each ml contains
Minoxidil ….50 mg (5% w/v)
Pharmacological Group Other dermatologicals
Type of Form Form-5
Approval Status of product in Reference Regaine for Men Extra Strength Scalp Solution 5% w/v
Regulatory Authorities. Cutaneous Solution by M/s McNeil Products Limited (MHRA
Approved)
Me-too status Higrow Topical Solution 5%w/v by M/s Shaigan (R#052658)
Brand Name + Dosage Form + Strength Ciclo-G Lotion 1.5%w/w
Ciclopirox olamine…15mg (1.5% w/w)
Type of Form Form-5
Pack Size & Demanded Price 60ml ,90ml, 120ml /As per SRO
Approval Status of product in Reference Stieprox 15mg/g Shampoo by M/s GlaxoSmithKline
Regulatory Authorities. (Ireland) Limited (HPRA Ireland Approved)
Me-too status Stieprox Topical Liquid by M/s GSK (Reg#026392)
Decision: Approved.
Brand Name + Dosage Form + Strength D.Clor Lotion 20%w/v
Composition Each ml of Lotion contains
Aluminium chloride hexahydrate………..200 mg (20% w/v)
Pharmacological Group Other anti-acne preparations for topical use
Type of Form Form-5
Approval Status of product in Reference Anhydrol Forte 20% w/v Cutaneous Solution by M/s Diomed
Regulatory Authorities. Developments Limited (MHRA Approved)
Remarks of the Evaluator  Firm has applied as lotion whereas formulation approved
by MHRA is solution.
 Me-too status not confirmed from available database.
Brand Name + Dosage Form + Strength G-Mith Lotion
Composition Each100 ml lotion Contains:
Permethrin …0.5gm
Crotamiton …10 g
Pharmacological Group Scabicidal preparation
Type of Form Form-5
Remarks of the Evaluator  The formulation applied by the firm is not approved by
DRAP nor in Reference Regulatory Authorities.
 Firm has submitted that it wants to revise formulation to:
Each gram Contains:
Permethrin …50mg (5%w/w)
 Approval Status of revised product in Reference
Regulatory Authorities is KWELLADA-P LOTION 5%
w/w by M/s MEDTECH PRODUCTS INC (Health Canada
Approved)
 Me-too status of revised product is Bioscab lotion 5% by
M/s Bio-Labs (Reg#054774)
Decision: Deferred for further deliberation.
Brand Name + Dosage Form + Strength Ketocare Lotion 2 %w/w
Composition Each gram contain:
Ketoconazole…20mg (2%w/w)
Pharmacological Group Imidazole and triazole derivatives
Type of Form Form-5
Approval Status of product in Reference Nizoral Anti-Dandruff Shampoo 2%w/w by M/s McNeil
Regulatory Authorities. Products Limited (MHRA Approved)
Me-too status Ketonaz Lotion by M/s Sante (Reg#073453)
Remarks of the Evaluator  Firm initially applied as w/v whereas formulation approved
by MHRA is w/w.
 Firm has revised formulation on w/w basis with submission
of fee of Rs. 5000/- (Challan#0844646) Dated 09-05-2019
Brand Name + Dosage Form + Strength Clacin-L Lotion 1%w/v
Clindamycin (as phosphate) …10mg (1%w/v)
Type of Form Form-5
Approval Status of product in Reference Dalacin T Topical Lotion by M/s Star Pharmaceuticals Ltd
Me-too status Austaclin-T Lotion by M/s Bloom Pharmaceuticals (Pvt) Ltd
(Reg#063077)
Brand Name + Dosage Form + Strength Silkin 10%w/w Lotion
Composition Each mg contains
Urea ….......................100 mg (10 % w/w)
Pharmacological Group Carbamide products(hydrating and keratolytic agent)
Type of Form Form-5
Approval Status of product in Reference EUCERIN INTENSIVE 10% W/W UREA TREATMENT
Regulatory Authorities. LOTION. By M/s Beiersdorf UK Limited, (HPRA, Ireland
Approved)
GMP Status 20-12-2017
Panel recommends grant of DML.
Remarks of the Evaluator  Me-too status not confirmed from available database.
Brand Name + Dosage Form + Strength Flucel Lotion 5 %w/w
Fluorouracil ….................50mg (5%w/w)
Pharmacological Group Antimetabolites (Pyrimidine analogues)
Type of Form Form-5
Approval Status of product in Reference Efudex topical solution 5%w/w by M/s ICN Pharmaceuticals
Regulatory Authorities. (USFDA Approved)
Capsule Section (General))
Brand Name + Dosage Form + Strength Tricin Capsule 250 mg
Azithromycin (as dihydrate) …250mg
Type of Form Form-5
Pack Size & Demanded Price 1x6‘s 5x6‘s & 1x10‘s As per SRO
Approval Status of product in Reference Azithromycin 250 mg Capsules by Jubilant
Regulatory Authorities. Pharmaceuticals nv. (MHRA approved)
Me-too status Azofas 250mg Capsules by Fassgen Pharmaceuticals.
(Reg#060291)
Decision: Approved.
Brand Name + Dosage Form + Strength Esocap Capsule 40 mg
Esomeprazole magnesium trihydrate (as enteric coated pellets
22.5%) eq. to Esomeprazole……40mg
Type of Form Form-5
Approval Status of product in Reference NEXIUM® (esomeprazole magnesium) 40mg delayed release
Regulatory Authorities. capsules, for oral use by Astra Zeneca Pharms. (USFDA
approved)
Me-too status Obpra Capsule 40mg by Obson Pharma. (Reg#054166)
Remarks of the Evaluator  Source of pellets:Vision Pharmaceuticals, Islamabad
Decision: Approved.
Brand Name + Dosage Form + Strength Well-P capsule 0.4 mg
Tamsulosin hydrochloride (as SR pellets 0.2%) …0.4mg
Pharmacological Group Alpha adrenergic antagonist
Type of Form Form-5
Pack Size & Demanded Price 10‘s, 20‘s , 30‘s . As per SRP
Approval Status of product in Reference Flomax 0.4mg capsule by M/s Boehringer Ingelheim
Regulatory Authorities. Pharmaceuticals (USFDA Approved)
Me-too status Tamflo 0.4mg SR Capsule by M/s Genome Pharma
(Reg#074562)
Remarks of the Evaluator  Source of pellets:Vision Pharmaceuticals, Islamabad
Decision: Approved.
Brand Name + Dosage Form + Strength Lozna Capsule 100 mg
Danazol.................. …100 mg
Pharmacological Group Antigonadotropins and similar agents
Type of Form Form-5
Pack Size & Demanded Price 30‘s, 100‘s/ As per SRO
Approval Status of product in Reference Danazol Capsules 100mg by M/s Generics (UK) Ltd t/a Mylan
Me-too status Serocrime100mg Capsules by Hilton (Reg#013162)
GMP Status 20-12-2017
Panel recommends grant of DML.
Remarks of the Evaluator  Firm does not have capsule steroid section to manufacture
applied product.
Decision: Deferred for confirmation of requisite section for the applied product.
Brand Name + Dosage Form + Strength Lozna Capsule 200 mg
Danazol....................... …200 mg
Pharmacological Group Antigonadotropins and similar agents
Type of Form Form-5
Pack Size & Demanded Price 30‘s, 100‘s/ As per SRO
Approval Status of product in Reference Danazol Capsules 200mg by M/s Generics (UK) Ltd t/a Mylan
Me-too status Danzol 200mg Capsules by Platinum Pharma (Reg#034832)
Remarks of the Evaluator  Firm does not have capsule steroid section to manufacture
applied product.
Decision: Deferred for confirmation of requisite section for the applied product.
Brand Name + Dosage Form + Strength Olanzatin 3mg/25mg Capsule
Olanzapine…3mg
Fluoxetine (as hydrochloride) …25mg.
Pharmacological Group Antidepressants in combination with psycholeptics
Type of Form Form-5
Pack Size & Demanded Price 14‘s & 30‘s / As per SRO
Approval Status of product in Reference Symbyax 3mg/25mg capsule by Eli Lilly (USFDA Approved)
Me-too status Co-Depricap 3/25mg Capsule by M/s Nabi Qasim Industries
Pvt.Ltd. (Reg#076136)
Decision: Approved.
Olanzapine…6mg
Type of Form Form-5
Pack Size & Demanded Price 14‘s & 30‘s / As per SRO
Me-too status Co-Depricap 6/25mg Capsule by M/s NabiQasim Industries
Pvt.Ltd. (Reg#076135)
Decision: Approved.
Olanzapine…12mg
Type of Form Form-5
Pack Size & Demanded Price 10‘s / As per SRO
Me-too status Olanco Capsules 12/25mg by M/s Genome (Reg#064014)
Decision: Approved.
Brand Name + Dosage Form + Strength Premac Capsule 100 mg
Pregabalin …100mg
Type of Form Form-5
Pack Size & Demanded Price 14‘s / As Per SRO
Approval Status of product in Reference Alzain 100 mg Capsules, Hard by Dr. Reddy‘s Laboratories
Regulatory Authorities. (UK) Ltd, (MHRA approved )
Me-too status Zeegap 100mg Capsules by Hilton Pharma (REG#047360)
Brand Name + Dosage Form + Strength Fungi-D capsule 150 mg
Fluconazole …150mg
Pharmacological Group Antimycotics For Systemic Use
Type of Form Form-5
Approval Status of product in Reference Fluconazole 150mg capsule by Bristol Laboratories
Regulatory Authorities. Limited. (MHRA approved)
Me-too status Fungon Capsules 150mg by Dyson Research
Laboratories. (Reg#055353)
Decision: Approved.
Brand Name + Dosage Form + Strength Gybix Capsule 60 mg
Duloxetine Hydrochloride (as 17% enteric coated pellets) eq. to
Duloxetine …60mg
Type of Form Form-5
Approval Status of product in Reference Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly,
Regulatory Authorities. (USFDA Approved)
Me-too status Dulan (Duloxetine 60 mg capsule) by M/s Hilton (R#055448)
Remarks of the Evaluator  Source of pellets: M/s Vision Pharmaceuticals, Islamabad
Decision: Approved.
Brand Name + Dosage Form + Strength Refit Capsule 120 mg
Orlistat …120mg
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form-5
Pack Size & Demanded Price 10‘s, 30‘s / As Per SRO
Approval Status of product in Reference Orlistat 120 mg capsules, hard by M/s TEVA UK Limited
Me-too status Osker 120mg Capsule by M/s Genix (Reg#066788)
Remarks of the Evaluator  Source of pellets not submitted by the firm.
Decision: Deferred for submission of source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of import of pellets.
Brand Name + Dosage Form + Strength Brotin Capsule 5 mg
Bromocriptine (as mesylate) …5 mg
Pharmacological Group Prolactine inhibitors
Type of Form Form-5
Approval Status of product in Reference Parlodel 5mg Capsules by M/s Mylan Products Ltd (MHRA
Me-too status Parlodel Capsule 5mg by M/s Sandoz (Reg#013745)
Decision: Deferred for confirmation of manufacturing facility.
Cream/Ointment Section (Steroid)
Brand Name + Dosage Form + Strength Closol Cream 0.05%w/w
Composition Each gram Contains:
Clobetasol Propionate… 0.5mg (0.05%w/w)
Pharmacological Group Corticosteroids, very potent (group IV)
Type of Form Form-5
Pack Size & Demanded Price 30 g. /As per SRO
Approval Status of product in Reference ClobaDerm 500 micrograms/g Cream by Auden Mckenzie
Regulatory Authorities. Pharma Division Ltd. (MHRA approved)
Me-too status Clobicare Cream by Martin Dow Ltd. (Reg#067938)
Decision: Approved.
Brand Name + Dosage Form + Strength Beta-N Cream
Betamethasone (as valerate)…1mg
Neomycin sulphate…….5mg
Pharmacological Group Corticosteroids, potent, combinations with antibiotics
Type of Form Form-5
Finished Product Specification Innovator‘s Specification
Approval Status of product in Reference Betnovate® N Cream by Suerte Pharma Ltd. (MHRA
Me-too status Betnovate-N Cream by GSK (Reg#000254)
Remarks of the Evaluator  Firm initially applied as Betamethasone …1mg, whereas
formulation approved by MHRA is Betamethasone (as
valerate) …1mg.
 Firm has revised formulation with submission of fee of Rs.
5000/- (Challan#0844645) Dated 09-05-2019
Brand Name + Dosage Form + Strength Beta-D Cream 0.05 %w/w
Composition Each gram Contains:
Betamethasone (as dipropionate) … 0.5mg (0.05%w/w)
Diary No, Date of R & I & fee Form-5 Dy.No 16722 dated 07-03-2019 Rs.20,000/- Dated 07-
03-2019
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form-5
Approval Status of product in Reference Diprosone Cream 0.05%w/w by M/s MERCK CANADA INC
Regulatory Authorities. (Health Canada Approved)
Me-too status Novasone Cream 0.05% by M/s Mass Pharma (Reg#024371)
Decision: Approved.
Brand Name + Dosage Form + Strength Clear –M Cream
Hydroquinone …40mg(4 %w/w)
Fluocinolone acetonoide …0.1mg (0.01 %w/w)
Tretinoin …0.5mg(0.05%w/w)
Type of Form Form-5
Pack Size & Demanded Price 15g, 30g/As per SRO
Approval Status of product in Reference TRI-LUMA® (fluocinolone acetonide,hydroquinone, and
Regulatory Authorities. tretinoin) cream, 0.01%, 4%, 0.05% for topical use by
Galderma Labs LP. (USFDA approved)
Me-too status Trimelasin Cream by Valor Pharmaceuticals. (Reg#031104)
Brand Name + Dosage Form + Strength Beta-F Cream
Fusidic acid …20 mg (2%w/w)
Betamethasone (as valerate) …1 mg (0.1%w/w)
Type of Form Form-5
Approval Status of product in Reference Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream by
Regulatory Authorities. Goapharma. (MHRA approved)
Me-too status Fusivate Cream by Macter International. (Reg#033014)
Brand Name + Dosage Form + Strength FUGET– H Cream
Fusidic acid….20 mg (2% w/w)
Hydrocortisone acetate…..10 mg (1% w/w)
Type of Form Form-5

Approval Status of product in Reference Fucidin H Cream by LEO Laboratories Limited. (MHRA
Regulatory Authorities. approved)
Me-too status Mirazym Cream of M/s Hiranis Karachi (Reg.# 076516)
Topical Lotion Section (Steroid)
Brand Name + Dosage Form + Strength Cloget Topical Solution 0.05%w/v
Clobetasol Propionate…0.5mg (0.05%w/v)
Pharmacological Group Corticosteroids, very potent (group IV)
Type of Form Form-5
Approval Status of product in Reference clobetasol propionate topical solution, 0.05%w/v by M/s
Regulatory Authorities. Actavis (USFDA Approved)
Me-too status Clobicare Lotion by Seatle (Reg#083857)
Decision: Approved.
Brand Name + Dosage Form + Strength Besa Lotion
Betamethasone (as dipropionate) …0.5mg (0.05%w/w)
Salicylic acid …20mg (2% w/w)
Pharmacological Group Corticosteroids, potent, combinations with kertolytic agent
Type of Form Form-5
Approval Status of product in Reference Diprosalic Scalp Application 0.05% w/w / 2% w/w, cutaneous
Regulatory Authorities. solution by M/s Merck Sharp & Dohme Limited (MHRA
Approved)
Me-too status Betamet-S Lotion by M/s Seatle (Private) Limited
(Reg#083858)
Remarks of the Evaluator  Firm initially applied as:
Each ml contains:
Betamethasone …0.5mg (0.05%w/v)
Salicylic acid …30mg (3% w/v)
Now firm has revised the formulation to:
Each gram contains:

Betamethasone (as dipropionate) …0.5mg (0.05%w/w)
Salicylic acid …20mg (2% w/w)

Firm has revised formulation with submission of fee of Rs.
20,000/- (Challan#0844647) Dated 09-05-2019

b. NEW/ADDITIONAL SECTION(S)
M/ s Berlex Lab International.., Multan (New section)

CLB in its 226th meeting held on 31st December 2010 has considered and granted new section to M/ s Berlex Lab
International.., Multan.
Firm submitted on 02-04-2019 that no product has yet been registered for psychotropic tablet section and they
may be allowed 10 products as per policy.
Firm‘s application was sent to Reg-II section on 08-05-2019 to confirm if any products of Tablet (Psychotropic)
Section have been registered till date for further processing.
Reg-II section replied on 09-05-2019 that as per record available in section, none of Tablet (Psychotropic) is
found registered on the name of applicant.
Sr.No Section No. of Products
1 Tablet (Psychotropic) Section 10
Tablet (Psychotropic) Section
10 Products
1653. Name and address of Manufacturer / M/s Berlex Lab International. 10-Km, Nagshah Chowk,
Applicant Karachi Road, Multan.
Brand Name + Dosage Form + Strength Xulax 2mg Tablet
Alprazolam…2mg
Pharmacological Group Benzodiazepine Derivative
Type of Form Form-5
Approval Status of product in Reference ALPRAZOLAM 2 mg TABLETS, USP by M/s JAMP Pharma
Regulatory Authorities. Corporation (Health Canada Approved)
Me-too status Pranax 2 mg Tablets by M/s Aries Pharma (Pvt.) Ltd.
(Reg#079370)
GMP Status 30-01-2018 & 09-04-2018.
Renewal of DML and grant of additional sections. Panel
recommends Renewal of DML and grant of additional sections.
Decision: Approved.
1654. Name and address of Manufacturer / M/s Berlex Lab International.
Applicant 10-Km, Nagshah Chowk, Karachi Road, Multan.
Brand Name + Dosage Form + Strength Xulax 1mg Tablet
Alprazolam…1mg
Diary No, Date of R & I & fee Form-5 Dy.No 42706 (13-12-2018) Rs.20,000/- 13-12-2018
Type of Form Form-5
Approval Status of product in Reference ALPRAZOLAM MYLAN 1 mg, scored tablet by M/s MYLAN
Regulatory Authorities. SAS (ANSM France Approved)
Me-too status Alprazolam 1 mg Tablets by M/s Heal Pharma (Reg#079392)
Decision: Approved.
Brand Name + Dosage Form + Strength Xulax 0.5mg Tablet
Alprazolam…0.25mg
Type of Form Form-5
Approval Status of product in Reference Xanax 500 microgram Tablets by M/s Pfizer Limited
Me-too status Azolam Tablet 0.5mg by M/s Tas Pharmaceuticals
(Reg#016521)
Decision: Approved.
Brand Name + Dosage Form + Strength Xitonil 3mg Tablet
Bromazepam…3mg
Type of Form Form-5
Approval Status of product in Reference Lexotan 3mg Tablets by M/s Roche Products Limited (HPRA
Regulatory Authorities. Ireland Approved)
Me-too status Bromota Tablet 3mg by M/s Orta Laboratories (Reg#065938)
Decision: Approved.
Brand Name + Dosage Form + Strength Xovibar 30mg Tablet
Phenobarbitone…30mg
Pharmacological Group Barbiturates and derivatives
Type of Form Form-5
Approval Status of product in Reference Phenobarbitone 30 mg Tablets by M/s Bristol Laboratories
Me-too status ALEPTAL Tablet 30mg by M/s Bloom Pharmaceuticals (Pvt)
Ltd (Reg#080596)
Decision: Approved.
Brand Name + Dosage Form + Strength Xepam 10mg Tablet
Diazepam…10mg
Type of Form Form-5
Approval Status of product in Reference Diazepam 10mg Tablets by M/s TEVA UK Limited (MHRA
Me-too status Dipam tablet 10mg by M/s Leads Pharma Pvt Ltd
(Reg#065300)
Decision: Approved.
Brand Name + Dosage Form + Strength Xepam 5mg Tablet
Diazepam…5mg
Type of Form Form-5
Approval Status of product in Reference Diazepam 5 mg Tablets by M/s TEVA UK Limited (MHRA
Me-too status Dipam tablet 5mg by M/s Leads Pharma Pvt Ltd (Reg#065299)
Decision: Approved.
Brand Name + Dosage Form + Strength Ritaxin 10mg Tablet
Methylphenidate Hydrochloride…10mg
Pharmacological Group Centrally acting sympathomimetics
Type of Form Form-5
Approval Status of product in Reference METHYLPHENIDATE HYDROCHLORIDE Tablet by M/s
Regulatory Authorities. SPECGX LLC (USFDA Approved)
Me-too status Phenida Tablets 10mg by M/s Zafa (Reg#034745)
Decision: Approved.

Brand Name + Dosage Form + Strength Bupnar 0.2mg Tablet
Buprenorphine as hydrochloride…0.2mg
Pharmacological Group Analgesics (Oripavine derivatives)
Type of Form Form-5
Me-too status Bunex 0.2mg Tablet by M/s Safe Pharma (Reg#053395)
Remarks of the Evaluator Firm has applied as uncoated tablet whereas formulation
approved in MHRA and TGA is sublingual tablet.
Decision: Deferred for revision of formulation and requsite fee.

Brand Name + Dosage Form + Strength Zolpida 10mg Tablet
Zolpidem Tartrate…10mg
Type of Form Form-5
Approval Status of product in Reference Zolpidem 10 mg Film-Coated Tablets by M/s Generics [UK]
Me-too status Somnia 10mg Tablets by M/s Wilshire Laboratories
(R#067737)
Decision: Approved.
Case No. 03 Registration Applications of Categories to be Considered on Priority.

a. Export Facilitation.
Applications was received through letter No.F.7-7/2017-Reg-II (Vol-III) dated: 30-04-2019
―M/s Tabros Pharma Pvt Ltd.Karachi have achieved benchmark of USD 762,638.93/- during fiscal year 2017-
2018. In this regard, please find the (5 molecule) applications:
1663. Name and address of Manufacturer / M/s Tabros Pharma Pvt Ltd.
Applicant L-20/B,Sector-22, Federal B Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Trozar 40mg Tablet
Composition Each film coated tablet contains;
Atorvastatin (as calcium trihydrate) …40mg
Type of Form Form-5
Approval Status of product in Atorvastatin 40 mg film-coated tablets by M/s KRKA, d.d.,
Me-too status Lipitor Tablets 40mg by M/s Parke-Davis (Reg#023622)
GMP Status 25-10-2018 Routine GMP inspection
cGMP compliance level is rated as good.
Decision: Approved.
Brand Name + Dosage Form + Strength Trozar 20mg Tablets
Type of Form Form-5
Decision: Approved.
Brand Name + Dosage Form + Strength Trozar 10mg Tablets
Type of Form Form-5
Decision: Approved.
Brand Name + Dosage Form + Strength Zynamite 6.4mg Tablet
Composition Each Sustained Release Tablet Contains:
Glyceryl Trinitrate…6.4mg
Pharmacological Group Vasodilators used in cardiac diseases (Organic nitrates)
Type of Form Form-5
Approval Status of product in SUSTAC Prolonged release tablets 6.4MG by M/s
Reference Regulatory Authorities. CHEMIDEX PHARMA LIMITED (MHRA Approved)
Me-too status Slotac SR tablet 6.4mg of M/s Werrick (Reg#025168)
Brand Name + Dosage Form + Strength Zynamite 2.6mg Tablet
Composition Each Sustained Release Tablet Contains:
Glyceryl Trinitrate…2.6mg
Pharmacological Group Vasodilators used in cardiac diseases (Organic nitrates)
Type of Form Form-5
Approval Status of product in SUSTAC Prolonged release tablets 2.6MG by M/s
Reference Regulatory Authorities. CHEMIDEX PHARMA LIMITED (MHRA Approved)
Me-too status Slotac SR tablet 2.6mg of M/s Werrick (Reg#025167)
Brand Name + Dosage Form + Strength Ansifix 50mg Tablet
Composition Each film-coated tablet Contains:
Sitagliptin (as phosphate monohydrate) …50mg
Pharmacological Group Dipeptidyl peptidase 4 (DPP-4) inhibitors
Type of Form Form-5
Approval Status of product in JANUVIA 50 mg film-coated tablet by M/s Merck Sharp
Reference Regulatory Authorities. Dohme (USFDA Approved)
Me-too status A-Glip 50mg Tablets by M/s Atco (Reg#053097)
Decision: Approved.
Type of Form Form-5
GMP Status As recoded for above application
Decision: Approved.
Type of Form Form-5
Decision: Approved.
Brand Name + Dosage Form + Strength Ansiget 50/500mg Tablet
Sitagliptin (as phospate monohydrate) …50mg
Diary No, Date of R & I & fee Form-5 Dy.No 6201 dated 13-02-2019 Rs.20,000/- 12-02-2019
Type of Form Form-5
Approval Status of product in Janumet 50/500 mg film coated Tablet by Merck Sharp &
Reference Regulatory Authorities. Dohme (Australia) Pty Ltd (TGA Approved)
Me-too status Treviamet 50mg/500mg Tablets by M/s GETZ Pharma Pakistan
(Reg# 055443)
Type of Form Form-5
Approval Status of product in Janumet 50/850 mg film coated Tablet by Merck Sharp &
Reference Regulatory Authorities. Dohme (Australia) Pty Ltd (TGA Approved)
Me-too status Treviamet 50mg + 850mg Tablet by Getz (Reg# 083315)
Type of Form Form-5
Approval Status of product in Janumet 50/1000 mg film coated Tablet by Merck
Me-too status Treviamet 50mg + 1000mg Tablet by Getz (Reg# 055444)
Brand Name + Dosage Form + Strength Colostan 3MIU IV powder for Injection and Infusion
Colistimethate Sodium 3million international units IU eq
to...........…240mg
Pharmacological Group Other antibacterials (Polymyxins)
Type of Form Form-5
Pack Size & Demanded Price 1‘s, 10‘s /As per SRO
Approval Status of product in Colistimethate sodium 3 MIU, powder for solution for injection
Reference Regulatory Authorities. by M/s PANMEDICA (MHRA Approved)
Decision: Deferred for submission of application on requisite form and differential fee and stability
study data as per the requirements of 278th meeting of Registration Board.

to…160mg
Type of Form Form-5
Decision: Deferred for submission of application on requisite form and differential fee and stability
study data as per the requirements of 278th meeting of Registration Board.
to…80mg
Type of Form Form-5
Me-too status Colistat powder for Injection 1MIU by M/s Medisure
(Reg#076160)
Decision: Approved.
Case No. 04 Registration applications of drugs for which stability study data is submitted
Specification
1677. M/s. Kaizen Cinacal Tablets 30mg Form 5 SENSIPAR (cinacalcet)
Pharmaceuticals (Pvt.) Dairy No. 17988 dated film-coated tablet 30mg by
Ltd; Plot No. E-127, E- Each film coated tablet 12-10-2017. M/s Amgen Inc. (USFDA
128 & E-129 North contains: Rs.20,000/- dated 28- approved)
Western Industrial Cinacalcet (as 09-2017.
Zone, Bin Qasim, hydrochloride)… 30mg Mimcipar 30mg Tablet by
Karachi. As per SRO, for 10‘s. M/s Genome (Reg#082301)
Anti-Parathyroid Agents As per SRO, for 20‘s.
(Other anti-parathyroid As per SRO, for 30‘s. Copy of GMP inspection
agents) report dated 18 & 31-07-
Manufacturer‘s 2017 recommending renewal
Specifications. of DML.
Drug Cinacal Tablets 30mg (Cinacalcet)
Name of Manufacturer M/s. Kaizen Pharmaceuticals (Pvt.) Ltd; Plot No. E-127, E-128 & E-129 North
Western Industrial Zone, Bin Qasim, Karachi.
Manufacturer of API Enaltec Labs Pvt. Ltd,
1706, 17th Floor, Plot No. 5, Kesar Solitaire, Sector-19, Navi Mumbai. Sanpada-
40070, Dist-Thane-Zone7, India.
API Lot No. EL-03/A100/16002
Description of Pack Alu/Alu blister
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Months)
Batch No. TF-01 TF-02 TF-03
Manufacturing Date September 2017 Feburary 2018 Feburary 2018
Date of Initiation December 2017 March 2018 March 2018
No. of Batches 03
Sr. Documents to Be Provided Status
No.
1) COA of API Copy of COA for Cinacalcet hydrochloride from M/s
Enaltec Labs Pvt. Ltd,, India has been submitted.
2) Approval of API by regulatory authority of country Photocopy of GMP Certificate No. 6078745 for
of origin or GMP certificate of API manufacturer Alembic Pharmaceuticals Limited, India issued by
issued by regulatory authority of country of origin. Food and Drugs Administration, Maharashtra, India is
submitted. Valid till 05-12-2018.
3) Protocols followed for conduction of stability
Yes
4) Data of 03 batches will be supported by attested
5) Documents confirming import of API etc. Copy Invoice submitted by the firm confirms import of
360.1grams Cinacalcet hydrochloride via DHL.
Batch no. is mentioned in invoice. Invoice is not ADC
attested.
6) All provided documents will be attested (name,
documents.
7) Commitment to continue real time stability study
Yes
8) Commitment to follow Drug Specification Rules, Yes
1978.
Evaluation by PEC:
 Invoice is not attested by ADC.
Decision:
Specification
1678. M/s. Kaizen Cinacal Tablets 60mg Form 5 SENSIPAR (cinacalcet)
Pharmaceuticals (Pvt.) Dairy No. 17989 dated film-coated tablet 60mg by
Ltd; Each film coated tablet 12-10-2017. M/s Amgen Inc. (USFDA
Plot No. E-127, E-128 contains: Rs.20,000/- dated 28- approved)
& E-129 North Cinacalcet (as 09-2017.
Western Industrial hydrochloride)… 60mg Mimcipar 60mg Tablet by
Zone, Bin Qasim, As per SRO, for 10‘s. M/s Genome (Reg#082302)
Karachi. Anti-Parathyroid Agents As per SRO, for 20‘s.
(Other anti-parathyroid As per SRO, for 30‘s. Copy of GMP inspection
agents) report dated 18 & 31-07-
Manufacturer‘s 2017 recommending renewal
Specifications. of DML.
Drug Cinacal Tablets 60mg (Cinacalcet)
Name of Manufacturer M/s. Kaizen Pharmaceuticals (Pvt.) Ltd; Plot No. E-127, E-128 & E-129 North
Western Industrial Zone, Bin Qasim, Karachi.
Manufacturer of API Enaltec Labs Pvt. Ltd, 1706, 17th Floor, Plot No. 5, Kesar Solitaire, Sector-19,
Navi Mumbai. Sanpada-40070, Dist-Thane-Zone7, India.
API Lot No. EL-03/A100/16002
Description of Pack Alu/Alu blister
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Months)
Batch No. TF-01 TF-02 TF-03
Manufacturing Date October 2017 Feburary 2018 Feburary 2018
Date of Initiation December 2017 March 2018 March 2018
No. of Batches 03
No.
1) COA of API Copy of COA for Cinacalcet hydrochloride from M/s
Enaltec Labs Pvt. Ltd,, India has been submitted.

2) Approval of API by regulatory authority of country Photocopy of GMP Certificate No. 6078745 for
of origin or GMP certificate of API manufacturer Alembic Pharmaceuticals Limited, India issued by
issued by regulatory authority of country of origin. Food and Drugs Administration, Maharashtra, India is
submitted. Valid till 05-12-2018.
3) Protocols followed for conduction of stability
Yes
5) Documents confirming import of API etc. Copy Invoice submitted by the firm confirms import of
360.1grams Cinacalcet hydrochloride via DHL.
Batch no. is mentioned in invoice. Invoice is not ADC
attested.
6) All provided documents will be attested (name,
documents.
7) Commitment to continue real time stability study
Yes
8) Commitment to follow Drug Specification Rules,
Yes
1978.
Evaluation by PEC:
 Invoice is not ADC attested.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Cinacal 30mg &
60mg Tablets (Cinacalcet as HCl) Tablets by M/s. Kaizen Pharmaceuticals, Pvt. Ltd., Bin Qasim, Karachi.
Investigation Date and Time: 28th February, 2019 (Forenoon).
Investigation Site: Factory premises of M/s. Kaizen Pharmaceuticals, (Pvt.), Ltd., Plot#E-127, E-
128 & E-129, North Western Industrial Zone, Bin Qasim, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Kaizen Pharmaceuticals, (Pvt.) Ltd., Bin
Qasim, Karachi for registration of Cinacal 30mg & 60mg (Cinacalcet as HCl) Tablets and constituted a three-
member panel to investigate the authenticity / genuineness of data (import of raw material and stability data).
Panel was advised to conduct inspection of the firm and to submit report for further consideration.
3. Dr. Kirshan Das, Assistant Director, DRAP Office, Karachi.
CINACAL 30MG & 60MG TABLETS
Sr.
No.
1 Do you have documents confirming the The firm has imported 50g batch No. (EL-03/A100/16001)
import of API ? Cinacalcet hydrochloride via DHL on 22-02-2017 and
360.1g batch No. (EL-03/A100/16002) also through DHL
on 28-02-2017 from M/s. Enaltec Lab, (Pvt) Ltd., India
Sr.
No.
vide in indenter Biofar, Karachi. The firm has got license
No. 3445 dated 05-12-2018 for 360.1g after the laps of 22
months which is not a proper procedure.
2 What was the rationale behind selecting the There is proper vendor qualification program being
particular manufacturer of API? implemented by the firm which includes GMP Status,
provision of DMF, reference standard, impurity standards
etc.
3 Do you have documents confirming the The firm has documents confirming the import of API
import of API reference standard and working standard batch No. (EL/IRS/A100/16/004),
impurity standards? however, any impurity standard has not been imported. As
per COA of the API there are two known impurities in the
API.
4 Do you have certificate of Analysis of the The firm has certificate of analysis for the API and
API, reference standards and impurity working standards of API. Two batches of working
standards? standards have been imported by the firm of which one was
expired in June, 2017 while other in September, 2018. The
firm has been conducting analysis with expired working
standard of the API.
5 Do you have any approval of API or GMP The firm has non-specific GMP certificate of the
certificate of API manufacturer issued by manufacturer issued by Food & Drug Administration,
regulatory authority of country of origin? Maharashtra, India.
6 Do you use API manufacturer method of The firm has used API manufacturer method for Assay
testing? only which is an isocratic method, however, the method for
related substances which is gradient method has not been
used to qualify / quantify the related substances.
7 Do you have stability studies reports on API? The firm has stability studies reports on API showing no
value against the impurities (A&B).
performed as per SIM method and method, however, no degradation products have been
degradation products have been quantified? found as per stability data provided for three API batches.
9 Do you have method for quantifying the The firm has method for quantifying the impurities in the
impurities in the API? API, however, this method has not been used.
10 Do you have some remaining quantities of The firm has some remaining quantities of the API,
the API, its reference standard and impurities working standard of the API, however, there is no quantity
standards? of any impurity as no impurity has been imported by the
firm.
11 Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients. The
excipients? excipients include Avicel PH 102 (BP), PVP-K30 (USP),
Aerosil-200 (USP), Magniesium Sterate (BP),
Pregelatinized Starch (USP), Crospovidone (BP) and
SheffCoat.
12 Do you have documents confirming the All the excipients have been purchased locally; however,
import of the used excipients? their COAs are available with the firm.
protocols for the development of API development of Cinacal (Cinacalcet) 30mg & 60mg tablets.
tablets?
15 Have you performed Drug-excipient Drug-excipients compatibility studies were not performed
compatibility studies? as the firm has used the same excipients as of innovator
(Mimpara, manufactured by M/S. Amgen, USA).
16 Have you performed comparative dissolution The firm has performed comparative dissolution studies
studies? only 60mg tablets in comparison to the innovator product
(Mimpara 60mg tablets) while employing FDA guidance
document for comparative dissolution profile. The firm
Sr.
No.
formulation have comparable dissolution profile with that
of the innovator product. Firm has not performed any
comparative dissolution profile study on 30mg tablets.
Moreover, the method used for assay in dissolution studies
is spectrophotometeric which needs to be validated.
17 Do you have product development (R&D) The firm has product development (R&D) section with
section equipment for manufacturing of tablet dosage form
whereas the analytical activities are performed in routine
QC lab.
18 Do you have necessary equipment available The firm has necessary equipment for product development
in product development section for in product development section however Cinacal tablets
development of API tablets? manual work (mixing in poly bag, wet massing in tray) and
production equipment (compression machine, tray dryer,
coating pan and blister machine) have been used.
20 Do you have proper maintenance / The firm has SOP for the
calibration / re-qualification program for the maintenance/calibration/requalification of equipment used
equipment used in PD section? on PD section.
21 Do you have qualified staff in product The firm has some qualified staff in product development
development section with proper knowledge section however, needs to be improved in all respects.
22 Have you manufactured three stability The firm has manufactured three stability batches for the
batches for the stability studies of Cinacal accelerated and real time stability studies of Cinacal tablet
tablets as required? Cinacal Tablet 30mg
(Batch No. TF-01, TF-02 and TF-03 each of 1000 tablets)
Cinacal Tablet 60mg
(Batch No. TF-01, TF-02 and TF-03 each of 1000 tablets).
The tablets are packed in Alu Alu blisters with pack size of
10‘s.
23 What was the criteria for fixing the batch The criteria for fixing the batch size of stability batches is
size of stability batches? the number of tablets per testing and the number of tablets
required for whole stability testing.
of stability batches? batches. Necessary log books of equipment used have been
available with the firm.
method for testing of stability batches? testing stability batches. The method is based on assay
method of API provided by API manufacturer. The method
is isocratic in non-selective / specific hence cannot quantify
the impurities (degradation products).
27 Do you have method transfer studies in case Validation is done for the assay method. However, the
when the method of testing being used by method is non-stability indicating.
28 Do you have documents confirming the The firm has documents confirming the qualification of
qualification of equipment / instruments equipment / instruments being used in the test and analysis
being used in the test and analysis of API of API and finished drug.
and the finished drug?
29 Do your method of analysis stability The firm‘s method of analysis is not stability indicating.
indicating?
30 Do your HPLC software is 21CFR The HPLC software is 21CFR Compliant as per record
compliant? available with the firm.
31 Can you show Audit Trail reports on API The firm showed the audit trail reports on API and finished
Sr.
No.
and finished product testing? product.
32 Do you have some remaining quantities of The firm has remaining quantities of stability batches only.
degradation products and stability batches? Degradation products have not been procured nor studied.
33 Do you have stability batches kept on real The firm has completed accelerated stability testing on the
time stability testing? three stability batches of both strengths. The real time
stability testing is in progress on all the three stability
batches. 12 months studies have been performed on the
first batch whereas, the rest two have been studied for 09
months. Significant variation i.e. > 5% degradation has
been found for all the three batches upto three months in
the accelerated testing. The real time studies upto 9 months
also show degradation about 6% for all three trail batches.
1% more degradation has been found in another 3 months
(12 months study) for the first trial batch (Batch#TF-01).
34 Do you have valid calibration status for the The firm has valid calibration status for the equipment used
equipment used in the production and in Cinacal tablets production and analysis.
analysis of API and tablets?
35 Do proper and continuous monitoring and Continuous power supply and monitoring are available for
control are available for stability chamber? stability chambers. More stability chambers are required
for future studies.
36 Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities be rated as GMP compliant.
compliant?
Conclusions:
1. Significant change has been found for all the three trial batches in accelerated stability testing at three
months. The firm has continued real time stability testing. The 12 months study on trial batch (TF-01)
show more than 7% degradation.
2. The firm is using non-stability indicating method therefore, the extent of actual degradation in the trial
batches could not be determined.
3. The firm has conducted comparative dissolution profile on 30mg tablets with innovator tablets (Mimpara,
30mg tablets, Manufactured by M/S. Amgen, USA) and have used an expired API working standard for
analysis at various time points.
Recommendations:
1. Keeping in view the above facts the genuineness / authenticity of stability data submitted by the firm for
registration of Cinacal 30mg & 60mg Tablets (Cinacalcet as HCl) Tablets are not verifiable.
2. Since > 7% degradation has already been found for one batch at 12 months real time stability studies,
although using non-stability indicated method which clearly indicate that the product is unstable and
extrapolated value of degradation will be outside the product specifications (Assay limit 90% - 110%)
even using non-stability indicating method.
3. The firm must re-design / conduct their studies with proper formulation and testing program using
authentic reference standards and stability indicating method under the guidance of proper product
development staff.
Note: The firm has also shown their interest to re-design the whole study.
Decision: Registration Board rejected the application for registration of Cinacal Tablets 30mg & Cinacal
Tablets 60mg (Cinacalcet (as hydrochloride)) by M/s. Kaizen Pharmaceuticals (Pvt.) Ltd; Plot No. E-127, E-
128 & E-129 North Western Industrial Zone, Bin Qasim, Karachi based on the observations in the Report
on Investigation of Authenticity / Genuineness of data for said products. Following are the observations:
1. Significant change has been found for all the three trial batches in accelerated stability testing at
three months. The firm has continued real time stability testing. The 12 months study on trial
batch (TF-01) show more than 7% degradation.
2. The firm is using non-stability indicating method therefore, the extent of actual degradation in the
trial batches could not be determined.
3. The firm has conducted comparative dissolution profile on 30mg tablets with innovator tablets
(Mimpara, 30mg tablets, Manufactured by M/S. Amgen, USA) and have used an expired API
working standard for analysis at various time points.

No. Manufacturer / Applicant (Proprietary Name + Initial Diary & Date, Fee Availability / Local
Dosage Form + (including differential Availability
Strength), Composition, fee),
1679. M/s Global Promig plus tablets Form 5-D Vimovo tablets
Pharmaceuticals (Pvt.) 375mg/20mg Dairy No. 27397 approved by
Ltd, Plot No. 204-205,, Each modified release dated 09-08-2018 USFDA
Industrial Triangle, tablet contains: Rs.50,000/-
Kahuta Road, Islamabad. Naproxen….…375mg 60‘s
Esomeprazole as As per DRAP‘s pricing
magnesium...… 20mg policy
(NSAID/Proton pump
inhibitor)
(Innovator‘s
Specifications)

Drug Promig plus tablets 375mg/20mg
Name of Manufacturer M/s Global Pharmaceuticals (Pvt.) Ltd, Plot No. 204-205, Industrial Triangle,
Kahuta Road, Islamabad.
Manufacturer of API Naproxen: M/s Zhejiang Tianxin Pharmaceutical Co., Ltd., Tiantai, Zhejiang, China.
Esomeprazole magnesium: M/s Metrochem API Private Limited, Telnagana State ,
India
Esomeprazole magnesium: ESM/1707301
Description of Pack HDPE Bottle with Silica gel, heat induction seal & child resistant closure.
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0,1,2,3,6 months
Batch No. PPT-01 PPT-02 PPT-03
No. of Batches 03
No.
i. COAs of API Submitted
ii. Approval of API by regulatory authority of country of Naproxen: Copy of GMP Certificate
origin or GMP certificate of API manufacturer issued (Certificate#. ZJ20140007) issued by SFDA to
by regulatory authority of country of origin. M/s Zhejiang Tianxin Pharmaceutical Co., Ltd.,
Tiantai, Zhejiang, China, valid upto 26-1-2019.
Esomeprazole magnesium: Copy of GMP
Certificate (Certificate#. L. Dis. No.
428/A2/2017) issued by DCA Government of
Telangana to M/s Metrochem API Private
Limited, Telnagana State, India and valid upto
February, 2018.
iii. Protocols followed for conduction of stability study
Submitted
iv. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory Submitted
v. Documents confirming import of API etc. Esomeprazole magnesium: Copy of license to
import raw material of Esomeprazole
magnesium (25Kg) issued by Assistant Director
I&E Islamabad, to the M/s Global
Pharmaceuticals (Pvt.) Ltd., to be used solely in
the manufacture of their registered product
―Esmazole tablet (Reg.# 056279).‖
Naproxen: Copy of license to import drug
Naproxen base (3Kg) for clinical, trial
examination, test for analysis issued by
Assistant Director I&E Islamabad, to the M/s
Global Pharmaceuticals (Pvt.) Ltd.
vi. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Submitted
documents.
vii. Commitment to continue real time stability study till
Submitted
viii. Commitment to follow Drug Specification Rules,
Submitted
1978.
i. Firm has submitted 6 months of Accelerated & Long term stability data.
ii. Firm has submitted that Esomeprazole drug layer is applied via coating and they have taken 6%
additional quantity of Esomeprazole focusing the loss in coating.
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Fee Availability /
Applicant Dosage Form + (including differential Local Availability
1680. M/s Global Promig plus tablets Form 5-D Vimovo tablets
Pharmaceuticals (Pvt.) 500mg/20mg Dairy No. 27398 approved by
Ltd, Plot No. 204-205,, Each modified release dated 09-08-2018 USFDA
Industrial Triangle, tablet contains: Rs.50,000/- -
Kahuta Road, Islamabad. Naproxen….…500mg 60‘s
Esomeprazole as As per DRAP‘s pricing
magnesium...… 20mg policy
(NSAID/Proton pump
inhibitor)
(Innovator‘s
Specifications)

th
Drug Promig plus tablets 500mg/20mg
Name of Manufacturer M/s Global Pharmaceuticals (Pvt.) Ltd, Plot No. 204-205, Industrial Triangle,
Kahuta Road, Islamabad.
Manufacturer of API Naproxen: M/s Zhejiang Tianxin Pharmaceutical Co., Ltd., Tiantai, Zhejiang, China.
Esomeprazole magnesium: M/s Metrochem API Private Limited, Telnagana State ,
India
Esomeprazole magnesium: ESM/1707301
Description of Pack
HDPE Bottle with Silica gel, heat induction seal & child resistant closure.
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0,1,2,3,6 months
Batch No. PPT-01 PPT-02 PPT-03
No. of Batches 03
No.
i. COAs of API Submitted
ii. Approval of API by regulatory authority of country of Naproxen: Copy of GMP Certificate
origin or GMP certificate of API manufacturer issued (Certificate#. ZJ20140007) issued by SFDA to
by regulatory authority of country of origin. M/s Zhejiang Tianxin Pharmaceutical Co., Ltd.,
Tiantai, Zhejiang, China, valid upto 26-01-
2019.
Esomeprazole magnesium: Copy of GMP
Certificate (Certificate#. L. Dis. No.
428/A2/2017) issued by DCA Government of
Telangana to M/s Metrochem API Private
Limited, Telnagana State, India and valid upto
February, 2018.
iii. Protocols followed for conduction of stability study
Submitted
iv. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory Submitted
v. Documents confirming import of API etc. Esomeprazole magnesium: Copy of license to
import raw material of Esomeprazole
magnesium (25Kg) issued by Assistant Director
I&E Islamabad, to the M/s Global
Pharmaceuticals (Pvt.) Ltd., to be used solely in
the manufacture of their registered product
―Esmazole tablet (Reg.# 056279).‖
Naproxen: Copy of license to import drug
Naproxen base (3Kg) for clinical, trial
examination, test for analysis issued by
Assistant Director I&E Islamabad, to the M/s
Global Pharmaceuticals (Pvt.) Ltd.
vi. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Submitted
documents.
vii. Commitment to continue real time stability study till
Submitted
viii. Commitment to follow Drug Specification Rules,
Submitted
1978.
iii. Firm has submitted 6 months of Accelerated & Long term stability data.
iv. Firm has submitted that Esomeprazole drug layer is applied via coating and they have taken 6%
additional quantity of Esomeprazole focusing the loss in coating.
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Promig Plus
500mg/20mg (Naproxen …..500 mg + Esomeprazole……20 mg) and Promig Plus 375mg/20mg (Naproxen
…..375 mg + Esomeprazole……20 mg) Tablets by M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-
205, Industrial Estate Triangle, Kahuta Road, Model Town, Islamabad.
Inspection Date and Time: 1st (Morning), 13th (Morning) and 14th (Morning) March,2019
Inspection Site: M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Estate Triangle,
Kahuta Road, Model Town, Islamabad.
Background:
M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Estate Triangle, Kahuta Road, Model
Town, Islamabad applied for registration of
Promig Plus 500mg/20mg (Naproxen …..500mg + Esomeprazole……20mg) Tablets and Promig Plus
375mg/20mg (Naproxen …..375mg + Esomeprazole……20 mg) Tablets with following composition:
Promig Plus 500mg/20mg Tablets

Each modified release tablet contains:-
Naproxen …………………500 mg
Esomeprazole Magnesium equivalent to Esomeprazole……20mg
Promig Plus 375mg/20mg Tablets

Each modified release tablet contains:-
Naproxen ………………....375mg
Esomeprazole Magnesium equivalent to Esomeprazole……20mg
Chairman Registration Board constituted following three member panel for on-site investigation
to confirm the genuineness/authenticity of submitted stability data and associated documents, import of API,
quality, specification, test analysis, facilities etc. Panel was requested to conduct inspection of the firm to verify
the submitted data by the firm and to submit a report on approved format for further consideration of case by the
Registration Board.
1. Additional Director, QA & LT, DRAP, Islamabad.
2. Area FID, Islamabad.
3. Mr. Arsalan Tariq, Assistant Director, QA & LT, DRAP, Islamabad.
documents, import of API, quality, specification, test analysis, facilities.

also audited. The details of findings/verification inspection are summarized as under:
Q.
#
1. Do you have documents confirming Naproxen
the import of API including Invoice Number: 16TXI-164
approval from DRAP? ADC attestation date: 05.08.2016
Exporter/Manufacturer: M/s Zhejaing Tianxin Pharmaceutical Co.
Ltd. No.215, Fengze Road, Tiantai County, Zhejiang Province
317200, China.
Batch No. NX 1604301
Manufacturing Date: 21.04.2016
Expiry Date: 20.04.2019
Quantity: 03 kg
Esomeprazole Magnesium
Invoice Number: AE/17/022
ADC attestation date: 07-08-2017
Exporter: M/s Metrochem API Private Ltd. Flat No.302, Bhanu
Enclave, Sunder Nagar Erragadda,Hyderabad-500038, T.S India
Manufacturer: M/s Metrochem API Private Ltd. Plot No. 62/C/6, Pipe
line road, phase-1IDA Jeedimetla, Hyderabad-500, Telangana State,
India
Batch No. ESM/1707301
Mfg. Date: July-2017
Exp. Date: June-2022
Quantity: 25Kg (The quantity was already in use in manufacturing of
commercial batches of registered product Esmazole Tablet 40mg
(Esomeprazole).
2. What was the rationale behind Naproxen
selecting the particular manufacturer The firm has submitted a comparison sheet showing different
of API? parameters to compare among 3 different API sources namely:
a. M/s Vervain Pharma-Chem India
b. M/s Wellona Pharmaceutical Ltd. India
c. M/s Zhejiang Tianxin Pharmaceutical Co. China
M/s Zhejiang Tianxin Pharmaceutical Co. Ltd. was selected on the
basis of Valid GMP, COA, good impurity profile, and good client list
of API manufacture contains International and Local client and
Stability Data (Accelerated and Real Time) as per requirement. The
firm is already using the ―Naproxen sodium‖ from the same suppliers.
The firm has submitted that M/s Metrochem API Private Ltd. Flat
No.302, Bhanu Enclave, Sunder Nagar Erragadda,Hyderabad-500038,
T.S India is their regular supplier and having Valid GMP by the
relevant regulatory authority.
The selection of vendor was discussed in detail in the light of GMP
guidelines and firm was advised to devise a comprehensive S.O.P
covering more parameters in details for the purpose. There should be a
detailed report/study for such prequalification studies.
3. Do you have documents confirming The firm imported following reference standards:
the import of reference standard and Naproxen:
impurity standards? Name of Source Batch Qty Invoice Mfg. Exp.
product No. No. date date
Working M/s Zhejiang 1112106 1 gm 16TXI- 06.2. 05.02.
Standard Tianxin 164 2015 2017

Pharmaceutica
l Co. Ltd.
The firm has developed tertiary working standard of Naproxen
from secondary standards provided by the Manufacturer/ source for
Naproxen.
Esomeprazole Magnesium:
Firm has imported primary standard from which they have and
impurities as per details below:
Name of Invoice Mfg. Exp.
Source Batch No. Qty
product No. date date
Esomepraz USP G0I290 10 783 - -
ole primary mg Purchased
reference via Cavax
standard Enterprises
Omeprazole As OP-IMP- 20 Purchased July, June
Sulphone above E/WS-01/17 mg via NEON 2017 ,
Chemicals, 2018
Pakistan
Omeprazole As OP-IMP- 20 As above July, June
N-oxide above E/WS-01/17 mg 2017 ,
2018
4. Do you have certificate of Analysis The firm has submitted COAs of following drugs (APIs)/materials of
of the API, reference standards and source as mentioned below:
impurity standards? Neproxen
 Neproxen (API) B. No. NX1604301
 Neproxen reference standard B.No.1112106
 Esomeprazole Magnesium (API) B. No. ESM/1707301
 Esomeprazole Magnesium Primary Standard from USP, B. No.
G0I290
 Impurity Standard Omeprazole Sulphone, B.No. OP-IMP-
E/WS-01/17
 Impurity Standard Omeprazole N-oxide, B.No. OP-IMP-E/WS-
01/17
5. Do you have GMP certificate of Neproxen
API manufacturer issued by The firm has submitted copy of GMP certificate No: ZJ20140007 in
regulatory authority of country of the name of Manufacturer that is ―M/s Zhejiang Tianxin
origin? Pharmaceutical Co. Ltd. No.215, Fengze Road, Tiantai County,
Zhejiang Province 317200, China.‖ of Neproxen by the Certifying
Authority of ―China Food & Drugs Administration, China.‖
Issued on: 27-01-2014
Valid up to: 26-01-2019
The firm has submitted copy of GMP certificate No:
L.Dis.No.428/A2/2017 in the name of Manufacturer that is ―M/s
Metrochem API Private Ltd. Unit-I, Plot No.62/C/6, pipeline road,
phase-1, IDA Jeedimetla, Hyderabad-500055, Telangana State, India
for source of Esomeprazole Magnesium by the Certifying Authority
of ―Drug Control Administration, Government of Telangana (India)‖
Issued on: 02-02-2017
Valid upto: 01 year from the date issue (01-02-2017).
6. Do you use API manufacturer The firm has used USP/pharmacopoeial method of testing for testing
method of testing for testing API? for the API Naproxen & Esomeprazole Magnesium.

7. Do you have stability studies reports Naproxen:
on API? Firm has submitted data of accelerated stability studies data (at 40 Co
+ 2 Co & 75 % RH + 5 %) of three batches 0605104 (Mfg: 3rd May,
2006), 0605105 (Mfg: 5th May, 2006), & 0605106 (Mfg: 6th May,
2006), up to 6 months and for real time (at 30 C o + 2 Co & 60 % RH +
5 %) data up to 36 month, conducted by the API manufacturer ―M/s
Zhejiang Tianxin Pharmaceutical Co. Ltd. No.215, Fengze Road,
Tiantai County, Zhejiang Province 317200, China. for API namely
Neproxen. The data submitted by the API manufacturers lies within
the limits for the assay, loss on drying & related substances.
Esomeprazole Magnesium:
Firm has submitted data of three batches ESM/A/200807076 (Mfg.:
July, 2008), ESM/A/200807077 (Mfg.: July, 2008), &
ESM/A/200807078 (Mfg.: July, 2008), for accelerated stability studies
(at 40 Co + 2 Co & 75 % RH + 5 %) up to 6 months and for real time
data (at 30 Co + 2 Co & 60 % RH + 5 %) up to 60 month, conducted
by the API manufacturer ―M/s Metrochem API Private Ltd. Plot No.
62/C/6, Pipe line road, phase-1IDA Jeedimetla, Hyderabad-500,
Telangana State, India for API namely Esomeprazole Magnesium.
The data submitted by the API manufacturers lies within the limits for
the Assay water & impurities.
8. If yes, whether the stability testing The firm has submitted the stability testing studies of the API
has been performed as per SIM verifying the determination of impurities, degradation products as per
method and degradation products USP/pharmacopoeial specifications.
have been quantified?
9. Do you have method for quantifying The firm stated that they have used the USP testing method for
the impurities in the API? quantifying the impurities in the API Naproxen (by using
chromatographic purity test) and Esomeprazole Magnesium.
10. Do you have some remaining The firm has submitted remaining quantities of the API, reference
quantities of the API, its reference standard and impurities standards as per details below:
standard and impurities standards?
Consum Remainin
Entity Received Consumption
S# Batch No. ed g amount
Name amount Details
amount (approx.)
Raw material
10g 2990gm
Testing
Three Stability
Batches
STRNGHTH
Naproxen 3kg 500/20 mg
1 NX1604301
PPT-01, PPT-
2625g 365gm
02,PPT-03
STRNGHTH
375/20 mg
PPT-01, PPT-
02,PPT-03
Three Stability
Batches
STRNGHTH
500/20 mg
Esomepraz
ESM/17073 PPT-01, PPT-
2 ole 0.5kg 143.4g 356.6gm
01 02,PPT-03
magnesium
STRNGHTH
375/20 mg
PPT-01, PPT-
02,PPT-03

Naproxen
Raw material
3 (Working. 1112106 1g 100mg 990mg
Testing
Standard )
Omeprazol OP-IMP- Approx: Finished Approx:
4 --------
e Sulphone E/WS-01/17 20mg product 20mg
omeprazole OP-IMP-
5 Approx: Finished --------- Approx:
N oxide E/WS-01/17
20mg product 20mg
11. Have you used pharmaceutical The firm has used pharmaceutical grade excipients as indicated from
grade excipients? the COAs submitted by firm.
12. Do you have documents confirming The firm purchased the excipients used in the applied formulation
the import of the used excipients? from local suppliers as per details below:
S# EXCIPIENT NAME Grade
1 PVP-K30 Pharmaceutical
2 Crosscarmellose Sodium Pharmaceutical
3 Talcum Pharmaceutical
4 Magnesium Stearate Pharmaceutical
5 Aerosil 200 Pharmaceutical
6 Eudragit L100 Pharmaceutical
7 Triacetin Chemical
8 Sodium Hydroxide Analytical
9 Tabcoat clear Pharmaceutical
10 Titanium Dioxide Pharmaceutical
11 Polyethylene Glycol 400 Pharmaceutical
12 HPMC E5 Pharmaceutical
13 Propyl paraben Pharmaceutical
14 Methyl paraben Pharmaceutical
15 Ethanol Pharmaceutical
13. Do you have test reports and other The firm has performed tests on above mentioned excipients and
records on the excipients used? hence has test reports and other records on the excipients used.
Remarks:
a) The firm has not performed complete tests for verifying the
quality of excipients.
b) The firm shows COA of Talcum with no test of Asbestos which
is a cancer causing agent.
14. Do you have written and authorized The firm has written and authorized protocols for the development of
protocols for the development of Promig Plus 500mg/20mg Tablet & Promig Plus 375mg/20mg Tablet.
Promig Plus 500mg/20mg Tablet & But submitted documented was not in accordance with ICH Q-8
Promig Plus 375mg/20mg Tablet which actually pertains to Pharmaceutical Development. The firm was
(Neproxen+Esomeprazole advised to improve the submitted protocol in the light of said
Magnesium)? document.
15. Have you performed Drug- The firm has not performed Drug-Excipients compatibility studies as
excipients compatibility studies? their formulation (API & Excipients) is similar/comparable to that of
the Vimovo Tablet approved by EMA.
16. Have you performed comparative The firm has performed comparative dissolution studies against the
dissolution studies? Vimovo Tablet 500 mg/20 mg (B# AAAN) approved by EMA.
However, the studies seems improvement for example the firm has
used 6 units for both test and reference products instead of 12 as
recommended in USFDA Guidance for Industry: Dissolution testing
of immediate release solid oral dosage form.
17. Do you have product development The firm possesses an approved Research & Development (R&D) and
(R&D) section Validation Department for product development studies.
18. Do you have necessary equipment The firm has following necessary equipment in R & D section for the
available in product development development of Promig Plus 500mg/20mg Tablet and 375mg/20mg
section for development of Promig Tablet.
Plus 500mg/20mg Tablet & Promig
Plus 375mg/20mg Tablet?
19. Are the equipment in product The equipment used in production and analysis of trial batches are
development section qualified? qualified as per details mentioned in reply of above question # 18.
20. Do you have proper The firm has calibration program for the equipment used in production
maintenance/calibration/re- and QC as per details mentioned in reply of question 18.
qualification program for the
equipment used in PD section?
21. Do you have qualified staff in The firm has appointed a team of following technical personnel:
product development section with Sr. #. Employee Name Designation Qualification Experience
proper knowledge and training in 1. Mr. Muhammad Manager M. Sc. 17 years
product development? Jamil R&D Analytical
Chemistry
2. Dr. Tanseer Executive Pharm -D 06 Years
Abbas
3. Atif Ali Executive M. Sc. 5 years
Chemistry
4. Dr. Anas Ullah Senior Pharm D 4.5 years
analyst
5. Muhammad Analyst M. Sc. 1.5 Years
Zubair Chemistry
6. Miss Kainat Zahra Pharmacist Pharm D 06 month
22. Have you manufactured three The firm has manufactured following three stability batches for the
stability batches for the stability stability studies of Promig Plus 500mg/20mg Tablet and Promig Plus
studies of Promig Plus 500mg/20mg 375mg/20mg Tablet:
Tablet Promig Plus 375mg/20mg S. No. Stability Batchs Batch Sizes
Tablet? Promig Plus 500mg/20mg Tablet
a. PPT-01 1000 tablets
b. PPT-02 1000 tablets
c. PPT-03 1000 tablets
Promig Plus 375mg/20mg Tablet
d. PPT-01 1000 tablets
e. PPT-02 1000 tablets
f. PPT-03 1000 tablets
23. Do you have any criteria for fixing The firm has set the criteria for fixing the batch size of stability
the batch size of stability batches? batches as/& derived the quantity sufficient for the studies both in
accelerated and real time studies to cover all testing time points as per
details below:
Tablets for
Batch Tablets for real Total packs per
accelerated
Sizes time studies batch required
studies
1000 420 Tablets 360 Tablets 780 Tablets
tablets OR OR OR

7 Packs 6 Packs 13 Packs
Batch size = 1000 Tablets, Pack Size 60‘S
24. Do you have complete record of The firm has complete record of production of stability batches.
production of stability batches? Starting from Raw Material manufacturing order sheet assuring the
traceability of manufacturing and analysis of all the three stability
batches.
25. Do you have protocols for stability The firm has controlled protocol for conducting stability studies on
testing of stability batches? batches of applied formulation at 30 Co + 2 Co & 65 % RH + 5 % for
real time studies and at 40 Co + 2 Co & 75 % RH + 5 % for accelerated
studies.
26. Do you have developed and The firm has used its own developed method for testing of finished
validated the method for testing of drug in their stability studies. The firm has also submitted a report
stability batches? verifying the validation studies of the analytical method covering
following parameters of validation:
i. Specificity
ii. Precision
a. Repeatability
b. Intermediate Precision
iii. Accuracy
iv. Linearity
v. Robustness
vi. System Suitability
vii. Limit of Quantification/Detection
viii. Range
27. Do you have method transfer studies The firm has not conducted method transfer studies. According to the
in case when the method of testing firm since their analytical method is developed by them hence no
being used by your firm is given by method transfer studies are required.
any other lab?
28. Do you have documents confirming The firm showed documents confirming the qualification of
the qualifications of equipment/instruments being used in the test and analysis of APIs and
equipment/instruments being used the finished drug as per details under question No:18.
in the test and analysis of APIs and
the finished drug?
The firm‘s method of testing is stability indicating for stability testing
29. Do your method of analysis stability
indicating? of their finished product, the data sheet submitted by firm verifies the
testing of impurity on samples kept on stability studies. The firm has
conducted impurity testing at one time at 6th month time point it was
discussed to conduct the impurity testing at initial and end time point
(i.e., at 0 and 6) to get an exact verification of impurity profiling/level.
30. Do your HPLC software is 21CFR Firm has 1 HPLC dedicated for R&D testing at the time of studies
compliant? conducted (now they have 2) and is 21 CFR II compliant. This HPLC
system is used for stability studies of Promig Plus 500mg/20mg Tablet
and Promig Plus 375mg/20mg. The HPLC used for the stability
studies is 21-CFR compliant. The record from logbooks, analytical
test reports was randomly found verifiable onsite. A complete trail of
such testing was available and verifiable.
31. Can you show Audit Trail reports A complete trail of such testing was found available and verifiable
on Promig Plus 500mg/20mg tablets from log books, analytical test reports and software of HPLC as well.
testing?
32. Do you have some remaining The firm has remaining quantities of stability batches as per following
quantities of degradation products details:
and stability batches?

Sample for Sample for Remain
Batch Total
S# Product Name Accelerated Real Time ing
No. packs
study Study Packs
Promig plus PPT-01 14 6 7 2
1 500/20mg PPT-02 16 6 7 2
Tablet PPT-03 15 6 7 2
Promig plus PPT-01 15 6 7 2
2 375/20mg PPT-02 15 6 7 2
Tablet PPT-03 15 6 7 2
33. Do you have stability batches kept The firm has completed the accelerated stability testing on the three
on stability testing? stability batches of Promig Plus 500mg/20mg Tablet and
375mg/20mg Promig Plus Tablet. Also the firm has completed the
real time stability testing up to 12 months on all three batches.
However, in real time studies the testing at 9th month time point is
missing.
34. Do you have valid calibration status The firm has valid calibration status for the equipment used in
for the equipments used in production and analysis of Promig Plus 500mg/20mg Tablet and
production in analysis? 375mg/20mg Promig Plus Tablet as per record available during onsite
visit.
35. Do proper and continuous Continuous power supply and monitoring with back up from generator
monitoring and control are available and UPS are available for stability chamber to address the problem of
for stability chamber? interrupted power supply or load shedding. Portable digital data
loggers are available for continuous monitoring of temperature and
humidity conditions of stability chamber. The firm submitted date-
wise data for every next hour of temperature and humidity conditions
of stability chambers used for accelerated and real time studies.
36. Do related manufacturing area, The related manufacturing area, equipment, personnel and utilities are
equipment, personnel and utilities rated as GMP compliant.
be rated as GMP compliant?
37. Applied technology of drug layering The firm stated that drug layer of Esomeprazole was applied on the
for Esomeprazole in which Drug is enteric coated Naproxen tablet (core) through manual coating
loaded via coating solution on the technique i.e. coating pan and spray gun.
core tablet of Naproxen.
38. Justification of 6% overage of In order to fix this percentage the firm performed several trials. First
esomeprazole in master formulation the firm applied 100% esomeprazole drug layer as dispersion in IPA,
(Which is required to be based on the results showed remarkable reduction in esomeprazole assay to
study/scientific rationale) for which 26.89%. The possible loss was due to use of esomeprazole as
firm has stated that additional dispersion and its loss during coating process. Then they decided to
quantity of Esomeprazole was used change the coating solution composition and applied esomeprazole
focusing the loss of coating. drug layer as solution in ethanol. Keeping in view of the drug loss
during coating the firm performed three consecutive trials with 120%
esomeprazole in coating solution in ethanol. The first trial B# T-012Q
(part I) yield a results 111.13%. The same formulation was again
trialed for two times B#T-012Q (Part II), B#T-012Q (Part III) with
more precaution and the results produced were 115.69% and 116.38%.
The average loss in all three 03 trials was 6%. Based on the average
loss a trial T-026 with 106% Esomeprazole in coating solution in
ethanol was conducted and the results achieved were 101.37%. Based
on these trials 6% overage was made as part of master formulation.
Conclusions & Recommendations:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of 375mg/20mg Promig Plus Tablet and Promig Plus 500mg/20mg tablets is verifiable to a satisfactory
level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suitable for the
manufacturing of 375mg/20mg Promig Plus Tablet and Promig Plus 500mg/20mg tablets, therefore, the panel

recommends the registration of Promig Plus 500mg/20mg tablets in the name of the manufacturer.
Decision: Registration Board decided to approve registration of ―Promig plus tablets 500mg/20mg & Promig
Plus tablets 375mg/20mg by by M/s. Global Pharmaceuticals (Pvt.) Ltd., Islamabad. Manufacturer will place
first three production batches of the product on long term stability studies throughout proposed shelf life and
b. Exemption from onsite verification of stability data

Finished Product size Date & Remarks
Specification
1681. M/s Saffron Elixa 2.5mg Tablets Form 5-D ELIQUIS (apixaban) film
Pharmaceuticals (Pvt) coated tablets 2.5mg by
Ltd. Each film coated Dairy No. 184 dated 07- M/s Bristol-Myers
19 km Sheikhupura tablet contains: 12-2015. Squibb Company
Road Apixaban …2.5mg Rs.50,000/- dated 28-11- (USFDA approved)
Faisalabad 2016.(Challan#0290354) The firm was last
Antithrombotic agent inspected on 03.10.2018,
(Direct factor Xa Rs.5040/- / 60‘s. .wherein the panel
inhibitor) recommended the grant
Manufacturer‘s of GMP certificate
Specifications.
Drug Elixa 2.5mg Tablets (Apixaban)
Name of Manufacturer M/s Saffron Pharmaceuticals (Pvt) Ltd.
Manufacturer of API M/s Glenmark Pharmaceuticals Limited, Plot#3109, GIDC, Industrial estate,
Ankleshwar city Ankleshwar-393002 District, Bharuch, Gujrat state India.
API Lot No. 801609708
Description of Pack Alu Alu Blister Pack in Unit carton
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 6 months Real Time: 9 months
Frequency Accelerated: 0,3,6 (months) Real Time: 0,3,6, 9, 12, 18, 24 (months)
Batch No. T-004 T-003 T-002
No. of Batches 03
No.
1) COA of API Method used for analysis of API along with copy of
COA for dapagli Apixaban from M/s Fuxin Long
Rui Pharmaceutical Co., Ltd. has been submitted.
2) Approval of API by regulatory authority of country Copy of GMP certificate issued by Food and Drugs
of origin or GMP certificate of API manufacturer control administration, Gujrat state India to,
issued by regulatory authority of country of origin. Glenmark Pharmaceuticals Limited. Plot#3109,
GIDC, Industrial estate, Ankleshwar city
Ankleshwar-393002 District, Bharuch, Gujrat state
India valid up to 18-08- 2019.
3) Protocols followed for conduction of stability study
Yes
5) Documents confirming import of API etc.  Firm has submitted ADC attested copy dated 07-
02-2017 confirming import of 0.057 Kg
Apixaban.
 Batch no. 801609708
 Invoice no. 2006004973
 Firm has submitted copy of Form-3 confirming
import of API from M/s Glenmark
pharmaceuticals Ltd.
batch no of API i.e. 801609708.
6) All provided documents will be attested (name, sign
documents.
7) Commitment to continue real time stability study till
Yes
8) Commitment to follow Drug Specification Rules,
Yes
1978.
inspection for instant dosage form Saffaldi Tablet 400mg (Sofosbuvir), which was conducted on 8th
chambers. Data Loggers are also placed in stability chambers for
monitoring
2. Documents for the procurement of  Firm has submitted ADC attested copy dated 07-02-2017
API with approval from DRAP (in confirming import of 0.057 Kg Apixaban.
case of import). Batch no. 801609708
Invoice no. 2006004973
 Firm has submitted copy of Form-3 confirming import of API
from M/s Glenmark pharmaceuticals Ltd.
 Firm has submitted copy of Form-7 confirming batch no of
API i.e. 801609708.
3. Documents for the procurement of  Firm has submitted declaration from API manufacturer
reference standard and impurity regarding dispatiching of Apixaban working standard to M/s
standards. Saffron Pharmaceuticals.
 Quantity of working standard imported by the firm is n100mg
Batch#WD18801.01.
4. Approval of API/ DML/GMP Copy of GMP certificate issued by Food and Drugs control
th
certificate of API manufacturer administration, Gujrat state India to, Glenmark Pharmaceuticals
issued by regulatory authority of Limited. Plot#3109, GIDC, Industrial estate, Ankleshwar city
country of origin. Ankleshwar-393002 District, Bharuch, Gujrat state India valid up
to 18-08- 2019.
5. Mechanism for Vendor pre-  Firm has submitted vendor evaluation form which confirms the
qualification SOPs for vendor qualification. However, it is not filled by
either the manufacturer of API nor by the applicant.
6. Certificate of analysis of the API,  Certificate of analysis of the API submitted by the firm.
reference standards and impurity  COA of working standard submitted by the firm.
standards
7. Documents for the procurement of  Firm has submitted documents for procurement of excipients
development?
8. List of qualified staff involved in  Firm has submitted list of 2 qualified person working in
product development with relevant product development section.
experience.
Production Data
9. Authorized Protocols/SOP for the  Firm has submitted SOP for product design and development
development & stability testing of protocol (document # RD/GN/SP/002).
trial batches.  Firm has submitted SOPs for stability study protocol.
(document # RD/GN/SP/001)
10. Complete batch manufacturing  Firm has provided complete batch manufacturing record of all
record of three stability batches. the three batches.
11. Record of remaining quantities of Batch No Remaining
stability batches. Quantities of tablets
T-004 264
T-003 264
T-002 176
QA/QC DATA
12. Record of Digital data logger for  Firm has submitted manual records of stability chamber#3 for
temperature and humidity long term stability from 05-09-2017 to29-12-2017
monitoring of stability chambers  Firm has submitted record of digital data logger for
(real time and accelerated) temperature and humidity monitoring control for real time
stability study. The time period was from 01-01-2018 to 27-03-
2018.
 Another digital data submitted for long term stability study is
from 15-08-2018 to 25-01-2019.
 The data submitted for long term stability study does not cover
whole period.
 Firm has not submitted record of digital data logger for
temperature and humidity monitoring control for accelerated
stability study.
13. Method used for analysis of API  Method used for analysis of API along with copy of COA for
along with COA. Apixaban from M/s Glenmark pharmaceuticals Ltd. has been
submitted.
14. Method used for analysis of FPP &  Firm has provided method used for analysis of FPP
complete record of testing of Firm has submitted complete record of testing of stability batches
stability batches (i.e. including chromatograms, lab reports and raw data sheets
chromatograms, lab reports, raw data
sheets etc.)
15. Reports of stability studies of API  Firm has submitted summary sheet of 3 batches of API
from manufacturer. conducted at 40°C ± 2°C / 75% ± 5%RH for accelerated studies
for 6 months.
 Submitted summary sheet of long term stability study for 3
batches of API is conducted at 25°C ± 2°C / 60% ± 5%RH for
long term for 18months.
16. Analysis reports for excipients used.  Firm has submitted COA and analysis reports of all excipients
used in the study
17. Drug-excipients compatibility  Submitted by the firm.
studies.
18. Record of comparative dissolution  Firm has submitted Dissolution profile of FPP at 3 different
data. mediums i.e HCl buffer pH 1.2, Acetate Buffer pH 4.5,
Phosphate Buffer pH 6.8.
 However firm did not submit Dissolution profile of reference
product at above mentioned mediums thus also firm was
unable to calculate the f2 similarity factor.
on product testing.
Evaluation by PEC:
 Relevant chromatograms and FTIR spectrum, for generated COA of API by M/s Saffron
Pharmaceuticals (Pvt) Ltd are not submitted.
 Firm has not submitted dissolution profiles for reference product for CDP. Also, f2 similarity factor shall
be calculated and submitted.
 Relevant analytical record of CDP i.e. chromatograms, raw data sheets not submitted by the firm.
 Long term Stability studies of Apixaban as per Zone IV-A conditions from API manufacturer is not
submitted. Upon intimation to the firm, the response was, ―Required stability data according to Zone-IV-
A manufacturer has not provided the data due to current crisis between both the countries; we are
continuously having follow up regarding this matter.‖
 System generated electronic record of stability chambers for temperature and humidity conditions
covering the stability study duration is not submitted.
Decision: Registration Board decided to deferred the case for following:
i. Submission of relevant chromatograms and FTIR spectrum, for generated COA of API by
the firm.
ii. Submittion of dissolution profiles for reference product for CDP. Also, f2 similarity factor
shall be calculated and submitted.
iii. Submission of relevant analytical record of CDP i.e. chromatograms, raw data sheets.
iv. Submission of long term Stability studies of Apixaban as per Zone IV-A conditions from
API manufacturer.
v. Submission of system generated electronic record of stability chambers for temperature
and humidity conditions covering the stability study duration.
Finished Product size Date & Remarks
Specification
1682. M/s Saffron Elixa 5mg Tablets Form 5-D ELIQUIS (apixaban) film
Pharmaceuticals (Pvt) Each film coated coated tablets 5mg by
Ltd. tablet contains: Dairy No. 182 dated 07- M/s Bristol-Myers
Apixaban …5mg 12-2015. Squibb Company
19 km Sheikhupura Rs.50,000/- dated 28-11- (USFDA approved)
Road Antithrombotic agent 2016.(Challan#0290355) The firm was last
Faisalabad (Direct factor Xa inspected on 03.10.2018,
inhibitor) Rs.5040/- / 60‘s. .wherein the panel
Manufacturer‘s recommended the grant
Specifications. of GMP certificate
Drug Elixa 5mg Tablets (Apixaban)
Name of Manufacturer M/s Saffron Pharmaceuticals (Pvt) Ltd.

Manufacturer of API M/s Glenmark Pharmaceuticals Limited, Plot#3109, GIDC, Industrial estate,
Ankleshwar city Ankleshwar-393002 District, Bharuch, Gujrat state India.
API Lot No. 801609708
Description of Pack Alu Alu Blister Pack in Unit carton
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 9 months
Frequency Accelerated: 0,3,6 (months)
Real Time: 0,3,6, 9, 12, 18, 24 (months)
Batch No. T-004 T-003 T-002
No. of Batches 03
No.
1. COA of API Method used for analysis of API along with copy of
COA for dapagli Apixaban from M/s Fuxin Long
Rui Pharmaceutical Co., Ltd. has been submitted.
2. Approval of API by regulatory authority of country Copy of GMP certificate issued by Food and Drugs
of origin or GMP certificate of API manufacturer control administration, Gujrat state India to,
issued by regulatory authority of country of origin. Glenmark Pharmaceuticals Limited. Plot#3109,
GIDC, Industrial estate, Ankleshwar city
Ankleshwar-393002 District, Bharuch, Gujrat state
India valid up to 18-08- 2019.
Yes
5. Documents confirming import of API etc.  Firm has submitted ADC attested copy dated 07-
02-2017 confirming import of 0.057 Kg
Apixaban.
 Batch no. 801609708
 Invoice no. 2006004973
import of API from M/s Glenmark
pharmaceuticals Ltd.
batch no of API i.e. 801609708.
documents.
Yes

Yes
1978.
inspection for instant dosage form Saffaldi Tablet 400mg (Sofosbuvir), which was conducted on 8th
chambers. Data Loggers are also placed in stability chambers for
monitoring
2. Documents for the procurement of  Firm has submitted ADC attested copy dated 07-02-2017
API with approval from DRAP (in confirming import of 0.057 Kg Apixaban.
case of import). Batch no. 801609708
Invoice no. 2006004973
 Firm has submitted copy of Form-3 confirming import of API
from M/s Glenmark pharmaceuticals Ltd.
 Firm has submitted copy of Form-7 confirming batch no of
API i.e. 801609708.
3. Documents for the procurement of  Firm has submitted declaration from API manufacturer
reference standard and impurity regarding dispatiching of Apixaban working standard to M/s
standards. Saffron Pharmaceuticals.
 Quantity of working standard imported by the firm is n100mg
Batch#WD18801.01.
4. Approval of API/ DML/GMP Copy of GMP certificate issued by Food and Drugs control
certificate of API manufacturer administration, Gujrat state India to, Glenmark Pharmaceuticals
issued by regulatory authority of Limited. Plot#3109, GIDC, Industrial estate, Ankleshwar city
country of origin. Ankleshwar-393002 District, Bharuch, Gujrat state India valid up
to 18-08- 2019.
5. Mechanism for Vendor pre-  Firm has submitted vendor evaluation form which confirms the
qualification SOPs for vendor qualification. However, it is not filled by
either the manufacturer of API nor by the applicant.
6. Certificate of analysis of the API,  Certificate of analysis of the API submitted by the firm.
reference standards and impurity  COA of working standard submitted by the firm.
standards
7. Documents for the procurement of  Firm has submitted documents for procurement of excipients
development?
8. List of qualified staff involved in  Firm has submitted list of 2 qualified person working in
product development with relevant product development section.
experience.
Production Data
9. Authorized Protocols/SOP for the  Firm has submitted SOP for product design and development
development & stability testing of protocol (document # RD/GN/SP/002).
trial batches.  Firm has submitted SOPs for stability study protocol.
(document # RD/GN/SP/001)
10. Complete batch manufacturing  Firm has provided complete batch manufacturing record of all
record of three stability batches. the three batches.
11. Record of remaining quantities of Batch No Remaining Quantities of tablets
stability batches. T-004 316
T-003 212
T-002 176
QA/QC DATA
12. Record of Digital data logger for  Firm has submitted manual records of stability chamber#3 for
temperature and humidity long term stability from 05-09-2017 to29-12-2017
monitoring of stability chambers  Firm has submitted record of digital data logger for
(real time and accelerated) temperature and humidity monitoring control for real time
stability study. The time period was from 01-01-2018 to 27-03-
2018.
 Another digital data submitted for long term stability study is
from 15-08-2018 to 25-01-2019.
 The data submitted for long term stability study does not cover
whole period.
 Firm has not submitted record of digital data logger for
temperature and humidity monitoring control for accelerated
stability study.
13. Method used for analysis of API  Method used for analysis of API along with copy of COA for
along with COA. Apixaban from M/s Glenmark pharmaceuticals Ltd. has been
submitted.
14. Method used for analysis of FPP &  Firm has provided method used for analysis of FPP
complete record of testing of Firm has submitted complete record of testing of stability batches
stability batches (i.e.chromatograms, including chromatograms, lab reports and raw data sheets
lab reports, raw data sheets etc.)
15. Reports of stability studies of API  Firm has submitted summary sheet of 3 batches of API
from manufacturer. conducted at 40°C ± 2°C / 75% ± 5%RH for accelerated studies
for 6 months.
 Submitted summary sheet of long term stability study for 3
batches of API is conducted at 25°C ± 2°C / 60% ± 5%RH for
long term for 18months.
16. Analysis reports for excipients used.  Firm has submitted COA and analysis reports of all excipients
used in the study
17. Drug-excipients compatibility  Submitted by the firm.
studies.
18. Record of comparative dissolution  Firm has submitted Dissolution profile of FPP at 3 different
data. mediums i.e HCl buffer pH 1.2, Acetate Buffer pH 4.5,
Phosphate Buffer pH 6.8.
 However firm did not submit Dissolution profile of reference
product at above mentioned mediums thus also firm was
unable to calculate the f2 similarity factor.
on product testing.
Evaluation by PEC:
 Relevant chromatograms and FTIR spectrum, for generated COA of API by M/s Saffron
Pharmaceuticals (Pvt) Ltd are not submitted.
 Firm has not submitted dissolution profiles for reference product for CDP. Also, f2 similarity factor shall
be calculated and submitted.
 Relevant analytical record of CDP i.e. chromatograms, raw data sheets not submitted by the firm.
 Long term Stability studies of Apixaban as per Zone IV-A conditions from API manufacturer is not
submitted. Upon intimation to the firm, the response was, ―Required stability data according to Zone-IV-
A manufacturer has not provided the data due to current crisis between both the countries; we are
continuously having follow up regarding this matter.‖
 System generated electronic record of stability chambers for temperature and humidity conditions
covering the stability study duration is not submitted.
Decision: Registration Board decided to deferred the case for following:
i. Submission of relevant chromatograms and FTIR spectrum, for generated COA of API by
the firm.
ii. Submittion of dissolution profiles for reference product for CDP. Also, f2 similarity factor

shall be calculated and submitted.
iii. Submission of relevant analytical record of CDP i.e. chromatograms, raw data sheets.
iv. Submission of long term Stability studies of Apixaban as per Zone IV-A conditions from
API manufacturer.
v. Submission of system generated electronic record of stability chambers for temperature
and humidity conditions covering the stability study duration.
Evaluator PEC-XIII
Case No. 01 Registration applications for local manufacturing of (Human) drugs.
a. Deferred cases
1683. Name and address of manufacturer / M/s Iceberg Pharmaceuticals (Pvt) Ltd, Risalpur.
Applicant Contract Manufacturer: M/s Bio-Labs (Pvt) Ltd,Plot # 145,
Industrial triangle, Islamabad.
Brand Name +Dosage Form + Strength M- Xone 250mg Injection I/M
Ceftriaxone Sodium eq. to Ceftriaxone……….250mg
Diary No. Date of R& I & fee Dy. No. 187, 24-04-2017; Rs.50,000/- (24-04-2017)
Type of Form Form-5
Pack size & Demanded Price 1‘s & as per SRO
Approval status of product in Rocephin 250mg powder for solution for Injection vials of M/s
Reference Regulatory Authorities. Roche, UK (MHRA Approved)
Me-too status Rocephin of M/s Roche
GMP status M/s Iceberg: Last inspection 04-11-2016.
M/s Bio-Labs: Last inspection report dated 05 & 06-12-2017
concludes fair level of GMP compliance.
Previous remarks of the Evaluator  Firm has submitted that they have not registered any
product for contract manufacturing till date.
 Agreement between both the firms is submitted.
 Relevant section in the manufacturer firm is confirmed
as dry powder injection (Cephalosporin).
 M/s Iceberg‘s GMP inspection needs to be conducted.
Previous decision In 279th DRB meeting, Registration Board deferred the case for
assessment and confirmation of manufacturing capacity of M/s
Biolabs by panel to be constituted by Chairman Registration
Board for further granting contract manufacturing permission
as the firm has already been granted approval for contract
manufacturing of numerous products.
Evaluation by PEC  Firm has changed the Contract Manufacturer from M/s
Biolabs to M/s AstellasPharma.
 Applicant i.e. M/s Iceberg has 5 sections and they have
submitted that they have not been given registration of any
product on contract manufacturing till date.
 Manufacturer firm i.e. M/s Astellas Pharma has Dry
Powder Injection (Cephalosporin) section as mentioned in
the submitted section approval letter.
 Firm has submitted a copy of agreement between both the
firms.
 GMP inspection of M/s Astellas was conducted on 02-10-
2017 and the report concludes satisfactory level of GMP
compliance.
 Firm wants to apply these drugs on the same fees submitted
earlier on M/s Biolabs Contract basis.

GMP inspection of M/s Iceberg was conducted on 05-12-
2018 and the report concludes:
―Production of the firm shall remain suspended till
recommendation by panel & subsequent approval by theCLB.‖
Decision: Deferred for updated status of GMP of the applicant firm from QA & LT division as
inspection report submitted by the firm does not conclude GMP compliant status.
Applicant Contract Manufacturer: M/s Bio-Labs (Pvt) Ltd, Plot # 145,
Brand Name +Dosage Form + Strength M- Xone 500mg Injection I/M
Ceftriaxone Sodium eq. to Ceftriaxone..500mg
Diary No. Date of R& I & fee Dy. No. 186, 24-04-2017; Rs.50,000(24-04-2017)
Type of Form Form-5
Approval status of product in Rocephin powder for solution for Injection vials by
Reference Regulatory Authorities. Roche (MHRA Approved)
Me-too status Rocephin by Martin Dow
GMP status M/s Iceberg: Last inspection 04-11-2016
M/s Bio-Labs: Last inspection report dated 5 &6th
December, 2017 concludes fair level of GMP
compliance.
 M/s Iceberg‘s GMP inspection needs to be
conducted.
Biolabs to M/s AstellasPharma.
submitted that they have not been given registration of
any product on contract manufacturing till date.
Powder Injection (Cephalosporin) section as
 Firm has submitted a copy of agreement between both
the firms.
 GMP inspection of M/s Astellas was conducted on 02-
10-2017 and the report concludes satisfactory level of
GMP compliance.
 Firm wants to apply these drugs on the same fees
submitted earlier on M/s Biolabs Contract basis.
 GMP inspection of M/s Iceberg was conducted on 05-
12-2018and the report concludes:
recommendation by panel and subsequent approval by CLB.‖

Brand Name +Dosage Form + Strength M- Xone 1g Injection I/M
Ceftriaxone Sodium eq. to Ceftriaxone…….1g
Type of Form Form-5
Approval status of product in Rocephin powder for solution for Injection vials by Roche
Me-too status Rocephin by Martin Dow
M/s Bio-Labs: Last inspection report dated 5 & 6th
December, 2017 concludes fair level of GMP
compliance.
Biolabs to M/s Astellas Pharma.
the firms.
GMP compliance.

Brand Name +Dosage Form + Strength Senofer 20mg/ml Injection
Composition Each ml ampoule contains:-
Iron (as sucrose)…… 20 mg
Pharmacological Group Replenishes Hgb and depleted iron stores
Finished product Specification U.S.P.
Pack size & Demanded Price 5ml x 5‘s & as per PRC
Approval status of product in Venofer Injection by Vifor Pharma (UK MHRA Approved)
Me-too status Ferotein-S by Getz venofer of RG
 Manufacturer firm i.e. M/s Astellas Pharma has
General Liquid Injection section as mentioned in the
submitted section approval letter.
the firms.
GMP compliance.
Production of the firm shall remain suspended till
Brand Name +Dosage Form + Strength LNTROP-D Injection I/M
Cholecalciferol …… 5 mg (eq. to 2, 00,000 I.U.)
Type of Form Form-5
Pack size & Demanded Price ―1‘s, 5‘s‖ & As per SRO

Vitamin D3 Good 200,000 IU / 1 ml IM solution for injection
Reference Regulatory Authorities. (ANSM, France)
Me-too status Get D injection of M/s Getz Pharma
the firms.
GMP compliance.
12-2018 and the report concludes:
1688. Name and address of manufacturer / M/s Dr. Raza Pharma, Plot # 44- C, Industrial Estate,
Applicant Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Klary 250mg/ 5ml Dry Suspension
Clarithromycin ………..………...….250mg
Diary No. Date of R& I & fee Dy.No.17158; 05-10-2017; Rs.20,000(05-10-2017)
Pharmacological Group Antibiotic (Macrolide)
Pack size & Demanded Price 60ml, 90ml, 120ml & as per SRO
Me-too status Claritek 250mg/ 5ml Dry Suspension of M/s Getz Pharma
GMP status Last GMP inspection was conducted on 6th August, 2018 &
report concludes:
―Overall the GMP compliance is satisfactory and the firm is
advised to prepare a plan for the rectification of all the

deficiencies mentioned above at the earliest. They are further
directed to immediately get the approval/validation of their
layout plan from Licensing Division. The above points were
discussed with management and they agreed to rectify at the
earliest.‖
Previous remarks of the Evaluator General dry powder suspension section is not
available in the firm. Instead dry powder
suspension (Cephalosporin) and Dry suspension (Penicillin) is
available.
Previous decision  Deferred in 285th DRB meeting for following reasons:
Updated status of GMP of the firm form QA & LT division
as inspection report submitted by firm does not conclude
GMP compliant status.
 Approved manufacturing facility for ―General‖ dry powder
suspension section.
Evaluation by PEC  Firm has submitted its last GMP inspection report;
dated: 24-01-2019, and the report concludes
satisfactory GMP compliance.
 General dry powder suspension section is verified
through submitted GMP report dated 24-01-2019.
Decision: Approved
Brand Name +Dosage Form + Strength Klary tablet 500mg
Composition Each film- coated tablet contains:
Clarithromycin…….……500mg
Diary No. Date of R& I & fee Dy.No.17159; 05-10-2017;Rs.20,000 (05-10-2017)
Pharmacological Group Antibacterial (Macrolide)
Pack size & Demanded Price 10‘s, 20‘s, 30‘s. 50‘s, 100‘s,500‘s and 1000‘s & Rs. 450/-
Me-too status Arithro of M/s Novamed Pharmaceuticals (Reg. # 043479)
GMP status Last GMP inspection was conducted on 6th August, 2018and
the report concludes:
earliest.‖
Previous remarks of the Evaluator Firm has General tablet section.
Previous decision Deferred in 285th DRB meeting for updated status of GMP of
the firm form QA & LT division as inspection report submitted
Decision: Approved
Brand Name +Dosage Form + Strength Vixime dry suspension 200mg/ 5ml
Cefixime (as Trihydrate)………………200mg
Pharmacological Group Cephalosporin (Antibiotic)
Pack size & Demanded Price 60ml , 90ml, 120ml, 150ml & Rs. 300/-
Me-too status Cefspan 200mg Dry Suspension of M/s Barrett Hodgson(Reg.
# 024634)
earliest.‖
Previous remarks of the Evaluator  The official monograph of the applied formulation is
available in USP.
 Firm has dry powder suspension (Cephalosporin)
section.
Evaluation by PEC Firm has submitted its last GMP inspection report; dated: 24-
01-2019, and report concludes satisfactory GMP compliance.
Decision: Approved
Brand Name +Dosage Form + Strength Cifa 250mg Dry Suspension
Ciprofloxacin ………………………...250mg
Pharmacological Group Quinolones (Antibiotic)
Finished product Specification Manufacturers
Pack size & Demanded Price 60ml , 90ml, 120ml, 150ml & Rs. 160/-
Me-too status Mytil 250mg Dry Suspension of M/s Wilson (Reg. #027696)
directed to immediately get the approval/ validation of their
earliest.‖
Previous remarks of the Evaluator General dry powder suspension section is not
available in the firm. Instead dry powder
suspension (Cephalosporin) and Dry suspension (Penicillin) is
available.
Previous decision Deferred in 285th DRB meeting for following reasons:
 Updated status of GMP of the firm form QA & LT
division as inspection report submitted by firm does
not conclude GMP compliant status.

Approved manufacturing facility for ―General‖ dry
powder suspension section.
 General dry powder suspension section is verified
through submitted GMP report dated 24-01-2019.
formulation.
Decision: Approved with innovator‘s specifications. Diluent shall be as per innovator‘s product
1692. Name and address of manufacturer / M/s Rock Pharmaceutical Laboratories (Pvt) Limited, 134-B &
Applicant 135-B, Noushehra Industrial Estate, Risalpur.
Brand Name +Dosage Form + Strength Ropol tablets 500mg
Paracetamol ………..........................500mg
Diary No. Date of R& I & fee Dy. No. 192; 24-04-2017; Rs.20,000 (24-04-2017)
Pharmacological Group Non- Narcotic Analgesic
Type of Form Form-5
Pack size & Demanded Price 20x10‘s & as per SRO
Me-too status Panadol tablet 500mg of M/s GSK (Reg. # 000817)
GMP status Last GMP inspection report dated 07-12-2017 with no
conclusion.
Previous remarks of the Evaluator  A banned excipient called Methylene Chloride is
mentioned to be used under the heading of
specifications in Annexure-D of the dossier.
 The GMP report does not mention any conclusion.
Previous decision  Deferred in 281st DRB meeting for updated status of
GMP of the firm form QA & LT division as inspection
report submitted by firm does not conclude GMP
compliant status and justification of addition of a
banned excipient named Methylene Chloride.
Evaluation by PEC  Last GMP inspection was conducted 18-07-2018 and
the report concludes grant of GMP certificate.
 An Undertaking is submitted by the firm not to use any
banned excipient in any of their proposed formulation.
 Firm has General tablet section as mentioned in the
Decision: Approved
Brand Name +Dosage Form + Strength Macrozith tablet 500mg
Azithromycin Dihydrate eq. to Azithromycin..................500mg
Diary No. Date of R& I & fee Dy. No. 1040; 22-03-2017;Rs.20,000 (22-03-2017)
Pharmacological Group Macrolide
Type of Form Form-5
Me-too status Azomax tablet 500mg of M/s Novartis Pharma
conclusion.
mentioned to be used under the heading of specifications in
Annexure-D of the dossier.
Previous decision  Deferred in 281st DRB meeting for updated status of GMP
of the firm form QA & LT division as inspection report
submitted by firm does not conclude GMP compliant status
and justification of addition of a banned excipient named
Methylene Chloride.
Evaluation by PEC  Last GMP inspection was conducted 18-07-2018 and the
report concludes grant of GMP certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Valsam tablet 10mg/160mg
Amlodipine (as Besylate)……………….10mg
Valsartan……………………………….160mg
Pharmacological Group Angiotensin II antagonist and calcium channel blocker
Type of Form Form-5
Approval status of product in Exforge tablet 10mg/160mg of M/s Novartis Pharmaceuticals
Me-too status Exforge tablet 10mg/160mg of M/s Novartis Pharma, Pak
(Reg. # 047571)
conclusion.
mentioned to be used under the heading of
specifications in Annexure-D of the dossier.
Previous decision  Deferred in 281st DRB meeting for updated status of
GMP of the firm form QA & LT division as inspection
report submitted by firm does not conclude GMP
compliant status and justification of addition of a
banned excipient named Methylene Chloride.
Decision: Approved
Brand Name +Dosage Form + Strength Roxart tablet 20mg/120mg
Artemether………………….20mg
Lumefantrine ……………...120mg

Type of Form Form-5
Finished product Specification International Pharmacopoeia
Pack size & Demanded Price 2x8‘s & as per SRO
Approval status of product in WHO Approved as Dispersible tablet
Me-too status Artheget tablet 20mg/120mg of M/s Getz Pharmaceuticals,
Pak ( Reg. # 042295)
conclusion.
Previous remarks of the Evaluator  The GMP report does not mention any conclusion.
 The applied formulation is approved in WHO
prequalified list as dispersible tablet while not applied
as dispersible.
Previous decision Deferred in 281st DRB meeting for updated status of GMP of
by firm does not conclude GMP compliant status and type of
dosage form as dispersible tablet is approved in reference
regulatory authorities while not applied as dispersible.
 In WHO prequalified list of medicines, both type of
tablets are available i.e. uncoated as well as
dispersible. Firm has applied as uncoated which is
approved in WHO.
Decision: Approved
1696. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals, Plot # 122, Block- A , Phase-V,
Applicant Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength O-Carb oral granules Sachet 40/1100mg
Composition Each 4g of oral granules contains:
Omeprazole ………….…..40mg
Sodium Bicarbonate……1100mg
Pharmacological Group Proton Pump Inhibitor/ Salt solutions (Antacid)
Finished product Specification Innovators
Pack size & Demanded Price As per SRO & as per SRO
Approval status of product in Could not be confirmed in the applied strength (Sodium
Reference Regulatory Authorities. bicarbonate is approved in 1680mg)
Me-too status Could not be confirmed in the applied strength
(Sodium bicarbonate is approved in 1680mg)
GMP status Last inspection report conducted on 18-01-2018 recommending
renewal of DML.
Previous remarks of the Evaluator  The me-too and international evidence in the applied
strength could not be confirmed.
Previous decision Deferred in 285th DRB meeting for the following reasons:
by DRAP (generic / me-too status) along with
 Evidence of approval of applied formulation in
declared/approved by the Registration Board in its
275th meeting.
Evaluation by PEC  Now, the firm has corrected its formulation as

Omeprazole…………………………40mg
Sodium Bicarbonate…………..….1680mg
 Firm has submitted Rs. 20,000/- and has submitted new
Form- 5.
Decision: Approved
1697. Name and address of manufacturer / M/s Venus Pharma, 23 Km Multan Road, Lahore.
Applicant
Brand Name +Dosage Form + Strength Phenobarbital Injection 200mg/ ml
Phenobarbital Sodium ………………….200mg
Diary No. Date of R& I & fee Dy.No.17639; 11-05-2018; Rs.20,000 (11-05-2018)
Pharmacological Group Barbiturate and derivatives (Anti- epileptic)
Finished product Specification B.P.
Pack size & Demanded Price 1ml x 5 amp, 1ml x 100 ampoules & Rs. 150/- , Rs.250/-
Approval status of product in Phenobarbital sodium Injection of M/s Aspen (Australia
Reference Regulatory Authorities Approved)
Me-too status Phenobarb 200mg/ml of M/s Atco Pharma
report concludes renewal of DML.
Previous remarks of the Evaluator  Renewal of injectable ampoule (Psychotropic) section
was done on 10-12-2014.
 Firm has not mentioned whether they have applied as
glass ampoules or plastic ampoules while the reference
approves glass ampoules.
Previous decision Deferred in 283rd DRB meeting with following decision:
Registration Board referred the case to QA & LT Division to
conduct inspection of the firm.
Moreover, the firm needs to clarify the type of container
closure system whether they have
applied as glass ampoules or plastic.
Evaluation by PEC  Firm has submitted its latest GMP report dated: 9 th
July, 2018 concluding satisfactory GMP compliance
with grant of GMP certificate for export purpose.
 Firm has clarified the type of primary packaging
container as USP Type- I Glass Ampoule.
 Firm has Liquid Injectable Psychotropic (Vial and
ampoule) section as mentioned in the submitted section
approval letter.
Decision: Approved
1698. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt Ltd, 539-A Sundar
Applicant Industrial Estate, Raiwind Road ,Lahore
Brand Name +Dosage Form + Strength Vergo 24mg Tablet
Betahistine Dihydrochloride………………24mg
Diary No. Date of R& I & fee Dy.No. 4303, 06-02-2018, Rs. 20,000/-, 06-02-2018
Pharmacological Group Anti-Vertigo
Type of Form Form-5
Approval status of product in MHRA approved
Me-too status Vertin 24mg tablets of M/s Libra Pharmaceuticals
can‘t be verified because firm was not operational at the time
of inspection however premises were found well maintained

and at satisfactory level.
the firm form QA & LT division as inspection report
submitted by firm does not conclude GMP compliant status.
dated: 29-03-2019 concluding satisfactory level of
GMP compliance.
Decision: Approved
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
Liquid Syrup (General)

Applicant Triangle Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Respect 1mg/ml Oral Solution
Risperidone ………….… 1mg
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml/ MRP. Rs. As per SRO
Approval status of product in Risperdal 1mg/ml oral solution by M/s Janssen-Cilag Ltd
Reference Regulatory Authorities (MHRA Approved)
Me-too status Persch Oral solution 1mg/ml by M/s Barrett Hodgson Pakistan
Pvt. Ltd. (Reg. No. 032477)
GMP status New Section (Inspection Date: 19th Sep. 2018)
Remarks of the Evaluator XIII  Applied brand name may be changed.
Brand Name +Dosage Form + Strength Ronex Syrup 1g/ 5ml
Piracetam ……….1g
Diary No. Date of R& I & fee Dy.No.41083;06-12-2018;Rs.20,000 (06-12-2018)
Pharmacological Group Psycho-stimulant /Nootropic
Type of Form Form 5
Pack size & Demanded Price 120ml& As per SRO
Approval status of product in Piracetam Arrow 20% oral solution (Approved in ANSM
Reference Regulatory Authorities France)
Me-too status Benlon Syrup of M/s Akhai Pharmaceuticals (Reg. # 050796)
formation.
Brand Name +Dosage Form + Strength Espasevit Liquid Syrup 4mg/ 5ml
Ondansetron as OndansetronHCl ………. 4mg
Pharmacological Group Antacid/ Anti-emetic
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml & As per SRO
Me-too status Ondanles by Neo Medix Pharma (Reg. # 066472)
GMP status New Sections (Inspection Date: 19th Sep. 2018)
Remarks of the Evaluator XIII  No USP or BP monograph is available for the applied
formulation.
Brand Name +Dosage Form + Strength Domep 5mg/5ml Liquid suspension
Composition Each 5ml suspension contains:
Domperidone ……….………. 5mg
Pharmacological Group Propulsive/ Drugs for GIT disorders
Type of Form Form 5
Pack size & Demanded Price 60ml, 90ml & 120ml& As per SRO
Approval status of product in MHRA approved
Me-too status Domi 1mg/ml oral suspension of M/s Heal Pharma (R# 048021)
Remarks of the Evaluator XIII No USP or BP monograph is available for the applied
formulation.
Brand Name +Dosage Form + Strength R-Tine 10mg/5ml Liquid syrup
Memantine hydrochloride ………………... 10mg
Pharmacological Group Anti- dementia drug
Type of Form Form 5
Pack size & Demanded Price 120ml /MRP. Rs. As per SRO
Me-too status Zexa 10mg/5ml syrup by English Pharma (Reg. No. 071544)
formulation.
Brand Name +Dosage Form + Strength Megatron 50mg/5ml Syrup
Iron-III Hydroxide as Polymaltose Complex........... 50mg
Pharmacological Group Anti-anemic
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml, 450ml & As per SRO
Me-too status Irofer Syrup of M/s Hicon Pharmaceuticals(Reg. # 041475)
Decision: Approved
Brand Name +Dosage Form + Strength Rozic 20mg/5ml Syrup
Zinc Sulphate monohydrate eq. to Elemental Zinc … 20mg
Pharmacological Group Zinc Supplement
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml &Rs. As per SRO
Me-too status Osiris 20mg/5ml of M/s Sami (Reg. # 066902)
Remarks of the Evaluator XIII  The international availability of the applied formulation
could not be confirmed.
Brand Name +Dosage Form + Strength Zencit 1mg/ml Liquid Syrup
Cetirizine dihydrochloride ……………….… 1mg
Type of Form Form 5
Pack size & Demanded Price 60ml & 120ml & As per SRO
Me-too status Stamin Oral Solution 1mg/ml of M/s ShaiganPharma
(Reg. # 027006)
Decision: Approved
Brand Name +Dosage Form + Strength Katif 1mg/ 5ml Liquid Syrup
Ketotifen (as hydrogen fumarate) ……….… 1mg
Type of Form Form 5
Pack size & Demanded Price 60ml & As per SRO
Approval status of product in Zaditen 1mg/5ml oral solution by M/s Sigma Tau, ANSM
Reference Regulatory Authorities approved
Me-too status Tifien Syrup of M/s Hicon Pharma (Reg. # 041474)
formulation.
Decision: Deferred for evidence of approval of applied formulation in reference agencies as applied
formulation is Ketotifen (as hydrogen fumarate) 1mg/5ml syrup, which is different from quoted
reference i.e. ketotifen (as fumarate) 1mg/5ml syrup.
Brand Name +Dosage Form + Strength Rocit 100mg/ml Liquid Syrup
Citicoline (as sodium) …………………… 100mg
Pharmacological Group Psycho-stimulant / Nootropics
Type of Form Form 5
Pack size & Demanded Price 30ml & 60ml & As per SRO
Approval status of product in Citicoline Kern Pharma 100 mg / ml oral solution EFG by
Reference Regulatory Authorities KERN PHARMA, SL (Spain Approved)
Me-too status Cercolin syrup of M/s Schazoo Pharma
(Reg. No. 048985)
Remarks of the Evaluator XIII  No USP or BP monograph is available for the applied
formulation.
Decision: Approved
Dry Vial (Steroid)
Brand Name +Dosage Form + Strength Solu- Cort 100mg Injection
Hydrocortisone Sodium succinate eq. to hydrocortisone..100mg
Diary No. Date of R& I & fee Dy.No.40170;05-12-2018; Rs.20,000 (05-12-2018)
Type of Form Form 5
Pack size & Demanded Price 1‘s & As per SRO
Approval status of product in Solu- Cortef injection of M/s Pharmacia and Upjohn(USFDA
Me-too status Cortizone 100mg Injection of M/s Vision Pharma (R.# 081898)
XIII
Remarks of the Evaluator Firm has Sterile Dry powder Vial (Steroid) Section.
Brand Name +Dosage Form + Strength Solu- Cort 250mg Powder for Injection
Hydrocortisone Sodium succinate eq. to hydrocortisone..250mg
Type of Form Form 5
Approval status of product in Solu- Cortef injection of M/s Pharmacia and Upjohn (USFDA
Me-too status Cortizone 250mg Injection of M/s Vision Pharma (R.# 081899)
Remarks of the Evaluator XIII Firm has Sterile Dry powder Vial (Steroid) Section.
Brand Name +Dosage Form + Strength Solu- Cort 500mg (Powder for) Injection
Hydrocortisone Sodium succinate eq. to hydrocortisone...500mg
Type of Form Form 5
Me-too status Cortisone 500mg Injection of M/s Vision Pharma (R.# 081900)
XIII
Brand Name +Dosage Form + Strength Solu- Cort 1gm Injection
Hydrocortisone Sodium succinate eq. to hydrocortisone... 1g
Type of Form Form 5
Me-too status Could not be confirmed in the applied strength (available
strengths are 100mg,250mg & 500mg)

XIII
 Me- too status could not be confirmed in the applied
strength as available strengths are 100mg,250mg & 500mg.
me-too status) along with registration number, brand name and name of firm.
1713. Name and address of manufacturer / M/s RotexPharma (Pvt.) Ltd. Plot No. 206 & 207, Industrial
Brand Name +Dosage Form + Strength Solu- Med 40mg Injection
Methylprednisolone Sodium succinate eq. to
methylprednisolone..............40mg
Type of Form Form 5
Approval status of product in Solu-Medrone 40mg/ml of M/s Pfizer Limited (MHRA
Me-too status Depo-Medrol injection 40mg/ml by M/s Kurram IBD, Pakistan
(Reg.#000606)
Decision: Approved
methylprednisolone………………………. 125mg
Type of Form Form 5
Approval status of product in Solu- Medrone 125mg/ml of M/s Pfizer Limited (MHRA
Me-too status Solumedrol injection 125mg of M/s Ali Gohar& Company
(Reg. # 000599)
Decision: Approved
methylprednisolone………………………. 500mg
Type of Form Form 5
Approval status of product in Solu- Medrone 500mg/ml of M/s Pfizer Limited (MHRA
Me-too status Elcort 500mg Injection by M/s Vision Pharma
(Reg # 081903)
Decision: Approved
Brand Name +Dosage Form + Strength Solu- Med 1gm Injection
methylprednisolone……………………. 1gm
Type of Form Form 5
Approval status of product in Solu- Medrone 1g/ml of M/s Pfizer Limited (MHRA Approved)
Me-too status Solu- medrol injection 1000mg by M/s Kurram, ISB
(Reg. # 005806)
XIII
Decision: Approved

Case no. 03 Registration applications for local manufacturing of (veterinary) drugs.
a. Deferred Cases
Evaluator PEC XIII
1717. Name and address of manufacturer / M/s Inshal Pharmaceuticals, Plot # 2 Street SS-2 RCCI,
Applicant Industrial Area, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Citrolyte Powder 100g
Composition Each 100gm powder contains:
Vitamin C…………..….20gm
Paracetamol……………..2gm
Magnesium Sulphate.....3.5gm
Calcium Carbonate……4.5gm
Potassium Chloride…..….4gm
Diary No. Date of R& I & fee Dy.No.370;25-05-2011;8000/-(25-05-2011)&
Rs.12,000/- (05-12-2014)
Pack size & Demanded Price 30g, 50g, 100g, 250g, 500g, 1kg, 10kg, 25kg &
Decontrolled
Me-too status Spin-C Powder of M/s Leads Pharmaceuticals,
Islamabad (Reg. # 078239)
GMP status Last GMP inspection was conducted on 11-05-18 andthe
report concludes renewal of DML.
Previous remarks of the Evaluator Firm has Oral Powder Section (Veterinary).
Previous decision Deferred in 286th DRB meeting for submission of correct
pharmacological group.
Evaluation by PEC  Firm has submitted its correct pharmacological
group as NSAIDs + VITAMIN +
ELECTROLYTES.
Decision: Approved
1718. Name and address of manufacturer / M/s Prix Pharmaceuticals (Pvt.) Limited Plot # 5,
Applicant Pharmacity 30 km Multan Road, Lahore
Brand Name +Dosage Form + Strength Ectomec-10 Injection (10mg/ml)
Composition Each ml of vial contains:
Doramectin ……..10mg
Pharmacological Group Anti- parasitic
Pack size & Demanded Price 10ml glass vial & Decontrolled
Me-too status Doramec 10mg/ ml Injection of M/s SelmorePharma (Reg.
# 035149)
report concludes satisfactory GMP compliance.
Previous remarks of the Evaluator  Firm has General Injectable Liquid (Veterinary)
section.
 Vial section needs to be confirmed.
 GMP report has some observations.
Previous decision Deferred in 288th DRB meeting for updated status of GMP
of the firm form QA & LT division and confirmation of
injectable vial section.
Evaluation by PEC  The firm has submitted its latest inspection report
dated: 10-10-2018 and the report concludes renewal
of DML.
 General Liquid Injectable (vial) section is confirmed
by the submitted GMP report.
 No USP or BP monograph is available for the
1719. Name and address of manufacturer / M/s Prix Pharmaceuticals (Pvt.) Limited Plot # 5,
Applicant Pharmacity 30 km Multan Road, Lahore
Brand Name +Dosage Form + Strength Ectomec-10 Injection (10mg/ ml)
Doramectin ……..10mg
Pharmacological Group Anti- parasitic
Pack size & Demanded Price 100ml glass vial & Decontrolled
Me-too status Doramec-DMG Injection 100ml of M/s Leads Pharma (Reg.
# 043544)
Previous remarks of the Evaluator  Firm has General Injectable Liquid (Veterinary)
section.
of DML.
1720. Name and address of manufacturer / M/s Prix Pharmaceuticals (Pvt) Limited Plot # 5, Pharmacity
Applicant 30 km Multan Road, Lahore
Brand Name +Dosage Form + Strength Pri- Florcid Injection 300mg/ ml
Florfenicol ….…300mg
Pharmacological Group Fluorinated analogue of Chloramphenicol
Pack size & Demanded Price 100ml & Decontrolled
Me-too status Florofen Injection 300mg/ ml of M/s Leads Pharma (Reg. #
043160)
Previous remarks of the Evaluator Firm has General Injectable Liquid (Veterinary) section.
of DML.
Case No.04: Registration applications of Categories to be considered on Priority.
a. Export facilitation
1721. Name and address of manufacturer / M/s Genix Pharma (Pvt.) Limited, 44, 45-B Korangi Creek
Applicant Road, Karachi.
Brand Name +Dosage Form + Strength Vancom Dry Powder Injection 1g I/V
Vancomycin as HCl…………........1g
Diary No. Date of R& I & fee Dy.No.2041;16-01-2019; Rs.20,000/- (16-01-2019)
Pharmacological Group Anti- infective/ Antibiotic
Pack size & Demanded Price 1‘s & As per PRC
Me-too status Vinjec -1000mg Injection of M/s Bosch Pharma
(Reg. # 027573)
report concludes an acceptable level of GMP compliance.
 Firm has Dry Powder Injection (General) section as
Decision: Approved
1722. Name and address of manufacturer / M/s Medisure Laboratories (Pvt) Limited, A-115, S.I.T.E.,
Applicant Super Highway, Karachi
Brand Name +Dosage Form + Strength Ticalor tablet 90mg
Ticagrelor ………………..90mg
Diary No. Date of R& I & fee Dy.No.42669;13-12-2018; Rs.20,000/ (11-12-2018)
Pharmacological Group Platelet Aggregation Inhibitor
Me-too status Ticard Tablet 90mg of M/s Atco (Reg. # 089364)
report concludes good GMP compliance.
XIII
 Tablet General Section is available in the firm as
 Initially, film- coating was not applied in the master
formulation. Now, the firm has revised its
formulation as film-coated tablet.
 Stability is required against the applied formulation
according to the decision of 278th meeting.
Decision: Deferred for submission of six months accelerated and real time stability studies data
as the applied formulation is subsequent drug generic version.
Brand Name +Dosage Form + Strength Agolax tablet 25mg
Agomelatine ………….…25mg
Pack size & Demanded Price 1x 30‘s & As per SRO
Me-too status Valdoxan tablet 25mg of M/s Servier
(Reg.# 078160)
 Tablet General Section is available in the firm as
XIII
 No USP or BP monograph is applied for the applied
formulation.
 Film- coating was not applied in the master
formulation. Then, the firm revised its formulation
accordingly with submission of Rs. 5000/- fees.
Brand Name +Dosage Form + Strength Medi-Lade tablet 25mg
Eltrombopag as Olamine…25mg
Pharmacological Group Anti- haemorrhagic
Me-too status Revoladetablet 25mg of M/s GSK(Reg. # 069584)
Remarks of the Evaluator XIII  Tablet General Section is available in the firm as
formulation.
Brand Name +Dosage Form + Strength Medi-Lade tablet 50mg
Eltrombopag as Olamine ………50mg
Pharmacological Group Anti- haemorrhagic
Me-too status Revolade tablet 50mg of M/s GSK (Reg. # 069585)
Remarks of the Evaluator XIII  Tablet General Section is available in the firm as
formulation.
Evaluator PEC-XIV
Case no. 01 Registration applications for local manufacturing of (Human) drugs
Deferred cases:
1726. Name and address of manufacturer / M/s Shaigan Pharmaceuticals (pvt) Ltd, 14 Km Adyala Road,
Applicant Post office Dhgal, Rawalpindi-Pakistan
Brand Name +Dosage Form + Strength Clycin T Gel
Composition Each gram of Topical gel contains:
Clindamycin (as phosphate)………10mg
Type of Form Form 5
Pack size & Demanded Price 1‘s x 5gm; Rs. 75;
1‘s x 10gm; Rs. 130
Me-too status Uniclin Gel by M/s Kaizen Pharma, Karachi (R. No. 076304)
GMP status Inspection report dated 17-08-2016 recommended for the grant
of additional sections
Previous decision(s) Deferred for submission of latest GMP inspection report
conducted within last 1 year by DRAP. (M-274)
Evaluation by PEC Copy of panel inspection dated 06-08-2018 concluded that the
company is found complying GMP as of today and panel
unanimously agreed to issue GMP certificate.
Decision: Approved.
1727. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road,
Applicant Post office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Zegrid 40 mg capsule
Omeprazole enteric coated pellets eq. to omeprazole…40mg
Diary No. Date of R& I & fee Dy. No.624; 6-1-2017; Rs. 20,000/-
Type of Form Form-5
Approval status of product in Losec 40 mg hard gastro-resistant capsules by Astra Zeneca
Reference Regulatory Authorities. UK Ltd.(MHRA approved)
Me-too status Losec 40mg capsule by M/s Barrett Hodgson
GMP status Last GMP inspection was conducted on 6-aug-2018 and the
report concludes issuance of GMP
Previous remarks of the Evaluator.  Source of pellets and related documents of M/S RA Chem
pharma Ltd (Plot # A-19-C, A-23A & A-23-B road No.
18, IDA Nacharam Medchal-Malkajgiri district 5000076
telangana india). GMP is issued by Drug control
administration gov of Telangana valid up to 2-4-2019.
 Stability data of pellets for 3 batches was provided
Previous decision(s) Deferred for submission of differential fee in case of import of
pellets (M-288).
Evaluation by PEC  The firm has submitted differential fee of Rs. 80,000/-
(Deposit slip # 1902995) dated 08-05-2019.
Decision: Approved.
1728. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road,
Applicant Post office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Zegrid 20 mg capsule
Omeprazole enteric coated pellets eq. to omeprazole……20mg
Type of Form Form-5
Approval status of product in Losec 20 mg hard gastro-resistant capsules by Astra Zeneca
Reference Regulatory Authorities. UK Ltd.(MHRA approved)
Me-too status Losec 20mg capsule by M/s Barrett Hodgson
GMP status Last GMP inspection was conducted on 6-aug-2018 and the
report concludes issuance of GMP
Previous remarks of the Evaluator.  Source of pellets and related documents of M/S RA Chem
pharma Ltd (Plot # A-19-C, A-23A & A-23-B road No.
18, IDA Nacharam Medchal-Malkajgiri district 5000076
telangana india). GMP is issued by Drug control
administration gov of Telangana valid up to 2-4-2019.
 Stability data of pellets for 3 batches was provided
Previous decision(s) Deferred for submission of differential fee in case of import of
pellets (M-288).
Evaluation by PEC  The firm has submitted differential fee of Rs. 80,000/-
Decision: Approved.
1729. Name and address of manufacturer / M/s Amarant Pharmaceuticals (Pvt) Ltd, Plot No. 168, Sector
Applicant No.23, Korangi industrial area, Karachi
Brand Name +Dosage Form + Strength Listan AH tablet
Amlodipine besylate eq to Amlodipine…..10mg
Valsartan………………………..…160mg
Hydrochlorothiazide………………..25mg
Diary No. Date of R& I & fee Dy. No. 175, 27-01-2017, Rs.20,000/- (24-01-2017)
Type of Form Form-5
Pack size & Demanded Price 14‘s, 28‘s, As per SRO
Approval status of product in Exforge HCT by Novartis Pharma
Reference Regulatory Authorities. (USFDA approved)
Me-too status Exforge HCT 10/160/25MG by Novartis Pharma
GMP status The inspection report conducted on 23-11-2016 concluded that
the firm is employing resources for upgradation as per
approved layout plan.

Previous remarks of the Evaluator. Last inspection report is older than 1 year.
Previous decision(s) Deferred for updated status of GMP of the firm form QA & LT
Evaluation by PEC Copy of inspection dated 24-07-2018 concluded as follows:
―During inspection active production was seen under way in
Tablet (G), Capsule (G) and in veterinary sections. Up-
gradation is expected to be completed within next few months.
After that firm would be able for inspection of grant of renewal
of their DML and & regularization of LoP. The firm was
further advised to get the changes made into approved LoP,
reapproved from concerned division. Based on the above stated
observations, their current GMP compliance level is rated as
GOOD.‖
Decision: Approved.
Valsartan……160mg
Hydrochlorothiazide……25mg
Type of Form Form-5
Me-too status Exforge HCT 5/160/25MG by Novartis Pharma
Evaluation by PEC As recoded for above application
Decision: Approved.
Hydrochlorothiazide……25mg
Type of Form Form-5
Me-too status Exforge 10/320/25MG by Novartis Pharma
Decision: Approved.
Hydrochlorothiazide……12.5mg
Type of Form Form-5
Me-too status Exforge HCT 5/160/12.5MG by Novartis Pharma
Decision: Approved.
Valsartan…………………….…160mg
Hydrochlorothiazide…………..…12.5mg
Type of Form Form-5
Me-too status Exforge HCT 10/160/12.5MG by Novartis Pharma
Decision: Approved.

Brand Name +Dosage Form + Strength Cefirant 200mg Capsule
Cefixime as trihydrate ………200 mg
Diary No. Date of R& I & fee Dy.No.481, 12-02-2011, Rs.8000/-, Rs.12,000/-, 25-6-2014
Pharmacological Group 3rd Generation cephalosporin
Type of Form Form-5
Finished product Specification USP specifications
Pack size & Demanded Price 6‘s ; As per PRC
Approval status of product in Approved in Spain
Me-too status Soxime Capsule 200mg by Swat Pharmaceuticals.
Previous decision(s) Deferred as per decision of 250th meeting of Registration
Board and verification of fee challan of Rs. 8000/- (M-268)
Decision: Approved.
Brand Name +Dosage Form + Strength ROTANA 60mg/1.5ml Injection
Composition Each Injection Vial Contains:
Cabazitaxel (anhydrous)……….60mg,
Polysorbate 80 q.s……………1.5ml
Each Diluent Vial Contains:
Ethanol 13% (w/w) in Water for injection…….4.5ml
Diary No. Date of R& I & fee Diary No:8329, 11-07-2017, Rs: 20,000/-
Pharmacological Group Antineoplastic agent (Taxane)
Type of Form Form 5
Pack size & Demanded Price Combine Pack of 1 Vial x 1.5ml of injection & 1 Vial x 5.7ml
Diluent/ As per SRO
Approval status of product in CABAZITAXEL SANOFI cabazitaxel 60mg/1.5mL
Reference Regulatory Authorities. concentrated injection vial by Sanofi-Aventis Australia Pty Ltd
(TGA Approved)
Me-too status Jevtana Injection 60mg/1.5ml by Sanofi-aventis (Reg#078125)
GMP status 30-03-2017. Grant of Additional Sections
Previous decision(s) Deferred for deliberation on manufacturing of diluent
(M-275).
conduct GMP inspection of Firm on priority (M-285).
Deferred for deliberation upon regulatory requirements for
registration of diluent alongwith applied formulation (M-287).
Evaluation by PEC The firm has referred the decision of 274th meeting wherein
Registration decided as under:
―For diluents in combo pack with drug, same fee as for product
and diluents shall be considered and single registration number
shall be allotted to combo pack.‖
 The firm is granted GMP certificate based on inspection
 The firm has submitted that DRAP has already approved and
issued us registration letter in Combo pack for Inj. Doxetal
120mg/6ml having 6ml vial injection plus 9ml diluent.
Brand Name +Dosage Form + Strength ROTAFER 15mg/2ml Injection
Calcium Folinate eq. to folinic acid…15mg
Type of Form Form 5
Pack size & Demanded Price 5‘s x 2ml/As per SRO
Approval status of product in DBL LEUCOVORIN CALCIUM Folinic Acid 15mg/2mL (as
Reference Regulatory Authorities. calcium folinate) Injection by Hospira Australia Pty Ltd (TGA
Approved)
Me-too status Kunyrin 15mg/2ml injection by Al-Habib (Reg. No. 021042)
GMP status 30-03-2017; Grant of Additional Sections
Previous decision(s) Deferred for confirmation/justification for manufacturing of the
applied product in Liquid Ampoule (Oncology) section as
applied product is not cytotoxic anti-cancer (M-275).
Evaluation by PEC  The firm has submitted that since it is not a cytotoxic
anticancer product, therefore kindly grant the registration for
Rotafer 15mg /2ml in General Liquid Ampoule section.
Brand Name +Dosage Form + Strength ROTAFER 50mg/5ml Injection
Calcium Folinate eq. to folinic acid…50mg
Type of Form Form 5
Pack size & Demanded Price 5‘s x 5ml/ As per SRO
Approval status of product in DBL LEUCOVORIN CALCIUM Folinic Acid 50mg/5mL (as
Reference Regulatory Authorities. calcium folinate) Injection by Hospira Australia Pty Ltd (TGA
Approved)
Me-too status Kunyrin 50mg/5ml injection by Al-Habib
(Reg. No. 021041)
GMP status 30-03-2017
Grant of Additional Sections
applied product is not cytotoxic anti-cancer (M-275).
Evaluation by PEC  The firm has submitted that since it is not a cytotoxic
anticancer product, therefore kindly grant the registration for
Rotafer 50mg /2ml in General Liquid Ampoule section.

Brand Name +Dosage Form + Strength ONCOFU 250mg/5ml Injection
Fluorouracil…250mg
Pharmacological Group Antimetabolite (Pyrimidine analogue)
Type of Form Form 5
Pack size & Demanded Price Pack of 1 Amp x 5ml, MRP. Rs. As per SRO
Approval status of product in Fluorouracil Injection, 50 mg/ml, solution for injection by
Reference Regulatory Authorities. medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6 22880 Wedel Germany (MHRA Approved)
Me-too status Fivuflu 250mg injection by Atco (Reg.# 045756)
Previous remarks of the Evaluator.  Confirmed as vial in MHRA but firm has applied in
ampoule packaging.
 Evidence of vial from available me-too database
Previous decision(s) Deferred for clarification/justification on scientific basis for
applied packaging material as reference product approved by
MHRA of UK is available in glass vial whereas firm has
applied for glass ampoule.(M-275).
Deferred for evidence of me-too status in applied fill volume of
5 ml (M-287).
Evaluation by PEC The firm has referred the decision of 274th meeting wherein
Registration Board has decided as me-too is available in 10ml
vial with type-1 glass and, the container closure is more safe as
ampoule does not have rubber stopper and thus DRB approved
that product.
The firm is granted GMP certificate based on inspection
conducted on 17-03-2017
The firm has submitted me-too reference ―UTORAL injection
of Al-Habib Corporation (Reg#021046)‖ which has been
verified from available database.
Decision: Approved.
Brand Name +Dosage Form + Strength ASP 10,000IU Powder for Injection
Composition Each Vail Contains:
L-Asparaginase………..10,000IU
Pharmacological Group Protein Synthesis inhibitor
Type of Form Form 5
Pack size & Demanded Price 1‘s Vial/
As per SRO
Approval status of product in Leunase 10,000KU injection vial by Sanofi-Aventis Australia
Reference Regulatory Authorities. Pty Ltd (TGA Approved)
Me-too status Leunase 10,000KU injection by M/s S. Ejazuddin and Co. (Reg
no. 044896)
applied product in Dry Powder Vial (Oncology) section in the
light of decision of Registration Board in its 271 st meeting
regarding ―Specific manufacturing requirements for certain
classes of drugs‖ (M-275).
Deferred for clarification of origin of API whether biological
source or synthetic (M-287).
Evaluation by PEC The firm is granted GMP certificate based on inspection
The firm has submitted source of API as ―Synthetic‖.
Decision: Registration Board deferred the case for further delibration regarding source of API.
Brand Name +Dosage Form + Strength OCTERO 0.05mg/ml Injection
Octreotide (as acetate)……….…0.05mg
Pharmacological Group Somatostatin analogue (Cytostatics)
Type of Form Form 5
Approval status of product in SANDOSTATIN (octreotide acetate)50mcg injection, solution
Reference Regulatory Authorities. by M/s Novartis Pharmaceuticals Corporation (USFDA
Approved)
Me-too status Sandostatin 0.05mg injection by Novartis
(Reg. No. 013473)
applied product is not cytotoxic anti-cancer. Moreover, source
of Octreotide (synthetic or biological) shall be submitted by the
applicant along with relevant documents (M-275).
Brand Name +Dosage Form + Strength OCTERO 0.1mg/ml Injection
Octreotide (as acetate)…….…0.1mg
Pharmacological Group Somatostatin analogue (Cytostatics)
Type of Form Form 5
Approval status of product in SANDOSTATIN (octreotide acetate)100mcg injection,
Reference Regulatory Authorities. solution by M/s Novartis Pharmaceuticals Corporation
(USFDA Approved)
Me-too status Sandostatin 0.1mg injection by Novartis (Reg. No. 013472)
applied product is not cytotoxic anti-cancer. Moreover, source
of Octreotide (synthetic or biological) shall be submitted by the
applicant along with relevant documents (M-275).
Brand Name +Dosage Form + Strength CITROMED oral Sachet
Composition Each 5gm sachet contains:
Sodium Bicarbonate……………………1.76g
Sodium citrate………………………...0.63g
Citric acid…………………………0.72g
Tartaric acid……………………….0.89g
Diary No. Date of R& I & fee 40241, 05-12-2018, 20,000/-, 04-12-2018
Pharmacological Group Urinary Alkaliniser
Type of Form Form 5
Finished product Specification In-house specifications
Approval status of product in TGA Approved formulation (4g) is
Reference Regulatory Authorities. Sodium bicarbonate…..1.76gm
Sodium citrate………..0.63gm
Citric acid……………0.72gm
Tartaric acid………….0.89gm
Me-too status Citro soda Sachet of Abbott Labs
Citric acid…………………………0.72g
Me-too is different.
GMP status Panel inspection dated 19-09-2018 recommended the grant of
additional section (Sachet General).
Previous decision(s) Deferred for following: (M-288)
Registration Board in its 275th meeting
Evaluation by PEC The firm has submitted revised Form-5 with fee challan of Rs.
5,000/-, (Deposit slip # 1930973) dated 30-04-2019.
Revised composition is below:
Each 5gm sachet contains:
Citric acid………………………………0.88g
The firm has submitted me-too reference of Citrosoda sachet
by Abbott (5g) (Reg # 008749)
Sodium bicarbonate…..2.145gm
Sodium citrate………….0.765gm
Citric acid…………..…0.88gm
Tartaric acid…………..1.075gm
Decision: Deferred for submission of differential fee for revision of formulation.
1743. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt.) Limited, Located at plot
Applicant No. E-145 to E-149, North Western Industrial Zone, Port
Qasim, Karachi.
Brand Name +Dosage Form + Strength Brethease 100mcg/6mcg Capsule
Formoterol Fumarate………….6mcg
Budesonide…………………….100mcg
Diary No. Date of R& I & fee Dy.No. 939, 28-10-2013, 20,000/-, 28-10-2013
Pharmacological Group Corticosteroid + selective beta2–adrenergic agonist
Type of Form Form-5
Me-too status Combivair 100mcg + 6mcg capsule of M/s Highnoon
GMP status Last GMP inspection conducted on 07-09-2017, and the
report concludes that the firm was considered to be
operating at satisfactory compliance with GMP guidelines.
Previous decision(s) Deferred for product specific inspection by Director DTL
Karachi alongwith FID with following verifications
(M-243):
 Confirmation of approval of formulation by the stringent
regulatory agencies.
 Confirmation of API in ultramicronized form.
Evaluation by PEC The firm has submitted copy of product specific inspection
conducted by Director DTL, Karachi and Area FID which
concludes as below:
―In the light of manufacturing, Quality Control, Storage
facilities and technical persons met, the panel is of the view to
recommend Registration of a) Aclidum Capsule, b) Brethease
200mcg/6mcg Capsule, c) Brethease 100mcg/6mcg Capsule, d)
Brethease 400mcg/6mcg Capsule to the firm under the Drug
Act, 1976.”
authorities/agencies adopted by the Registration Board in 275 th meeting.
Applicant No. E-145 to E-149, North Western Industrial Zone, Port
Qasim, Karachi.
Type of Form Form-5
Karachi alongwith FID alongwith following verifications (M-
243):
Applicant No. E-145 to E-149, North Western Industrial Zone , Port
Qasim, Karachi.
Type of Form Form-5
Karachi alongwith FID alongwith following verifications (M-
243):
Applicant No. E-145 to E-149, North Western Industrial Zone , Port
Qasim, Karachi.
Brand Name +Dosage Form + Strength Aclidum Capsule
Aclidinum Bromide 400mcg eq. to Aclidinum …343mcg
Pharmacological Group Anticholinergic
Type of Form Form-5
Pack size & Demanded Price Rs. 2250/ pack of 15‘s (Rs. 150/ capsule)

Previous decision(s) Deferred for product specific inspection & International
availability status in capsule dosage form (M-243):
1747. Name and address of manufacturer / M/s. Jaens Pharmaceutical Industries (Pvt) Ltd. Lahore
Applicant Contract manufactured by M/s. English Pharma, Lahore
Brand Name +Dosage Form + Strength Tenum 1gm Injection (IV)
Meropenem trihydrate equivalent to meropenem…1g
Diary No. Date of R& I & fee Dy No. 3087, 15-05-2013, Rs.50000/-, 15-05-2013
Pharmacological Group Carbapenems (ATC code: J01DH02)
Type of Form Form-5
Pack size & Demanded Price 1‘s; As per SROs
Approval status of product in Meronem IV 1g by Pfizer Limited
Me-too status Merem 1g injection by Global Pharma
GMP status GMP inspection of M/s Jeans pharma dated 20-12-2017
concluded that M/s Jeans Pharmaceuticals is operating
satisfactory. Overall hygienic condition of the firm was
satisfactory at the time of inspection, however, they were
advised to continue improvements in production and quality
control they agreed.
CLB in its 265th meeting held on 9th & 10th August, 2018 has
considered and approved the grant of DML (no. 000886) by
way of formulation to M/s Nicholas pharmaceuticals,
Islamabad.
Previous decision(s) Deferred for evidence of section approval for non-penicillin B-
Lactam antibiotics & clarification of Pharmacological group
(M-267).
Evaluation by PEC The firm M/s Jeans Pharma has requested to change the
contract manufacturing from M/s English Pharma to M/s
Nicholas Pharmaceuticals, Plot#34, Street#SS-2, National
Industrial Zone, Islamabad.
M/s Nicholas Pharmaceuticals, Islamabad has provided Dry
Powder Injectable section (Carbapenems) section.
The firm has clarified the pharmacological group
―Carbapenems‖.
Decision: Registration Board acceded to the firm‘s request and approved the formulation for
contract manufacturing with M/s Nicholas Pharmaceuticals, Plot#34, Street#SS-2, National
1748. Name and address of manufacturer / M/s. Jaens Pharmaceutical Industries (Pvt) Ltd. Lahore
Applicant Contract manufactured by M/s. English Pharma, Lahore
Brand Name +Dosage Form + Strength Tenum 500mg Injection (IV)
Meropenem trihydrate equivalent to meropenem…500mg
Pharmacological Group Carbapenems (ATC code: J01DH02)
Type of Form Form-5
Pack size & Demanded Price 1‘s; As per SROs
Approval status of product in Meronem IV 500 mg by Pfizer Limited
Me-too status Merem 500mg injection by Global Pharma
GMP status GMP inspection of M/s Jeans pharma dated 20-12-2017
concluded that M/s Jeans Pharmaceuticals is operating
satisfactory. Overall hygienic condition of the firm was
satisfactory at the time of inspection, however, they were
advised to continue improvements in production and quality
control they agreed.
CLB in its 265th meeting held on 9th & 10th August, 2018 has
considered and approved the grant of DML (no. 000886) by
way of formulation to M/s Nicholas pharmaceuticals,
Islamabad.
Previous decision(s) Deferred for evidence of section approval for non-penicillin B-
Lactam antibiotics & clarification of Pharmacological group
(M-267).
Evaluation by PEC The firm M/s Jeans Pharma has requested to change the
contract manufacturing from M/s English Pharma to M/s
Nicholas Pharmaceuticals, Plot#34, Street#SS-2, National
M/s Nicholas Pharmaceuticals, Islamabad has provided Dry
Powder Injectable section (Carbapenems) section.
The firm has clarified the pharmacological group
―Carbapenems‖.
Decision: Registration Board acceded to the firm‘s request and approved the formulation for
contract manufacturing with M/s Nicholas Pharmaceuticals, Plot#34, Street#SS-2, National
1749. Name and address of manufacturer / M/s Paramount Pharamceuticals, Plot No. 36, Industrial
Applicant triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Omeprazen 40mg
Composition Each capsule contains;
Omeprazole (as enteric coated pellets 8.5%)…....40mg
Diary No. Date of R& I & fee Dy No. 1977: 24-5-2016PKR 20,000/-: 24-5-2016
Type of Form Form 5
Approval status of product in Omeprazole by Actavis
Me-too status Xempra 40mg Capsule by Genome Pharmaceutical
GMP status Last inspection conducted on 30-12-2015
Previous remarks of the Evaluator.  GMP inspection is older than 1 year
 Source, COA, stability study data and GMP of manufacturer
of pellets is not provided
Previous decision(s) Deferred for following submissions: (M-274)
 Source of pellets
 Certificate of analysis of pellets
 Real time and accelerate stability study data of 3 batches of
pellets conducted as per the requirements of zone IV-A
 GMP of manufacturer of pellets
 Differential fee (if pellets are imported)
 GMP inspection report conducted within a period of last 1
year
Evaluation by PEC The firm has submitted Followings:

Source of pellets: M/s Vision pharma
The firm is granted GMP certificate based on inspection dated
20-11-2018.
Decision: Approved.
1750. Name and address of manufacturer / M/s Macter International (Private) Ltd, F-216, SITE, Karachi.
Applicant
Brand Name +Dosage Form + Strength Ramol Plus Tablet
Tramadol HCl…………...37.5mg
Paracetamol…………….325mg
Diary No. Date of R& I & fee Diary No.38, 02-08-2011, Rs.8,000.
Type of Form Form-5
Pack size & Demanded Price 10‘s, 20‘s, 30‘s, 40‘s; As per PRC
Approval status of product in Tramacet tablet of (MHRA approved)
Me-too status Radol-P tablet of M/s Regal Pharma
GMP status Last GMP inspection conducted on 23/05/2018, the firm is
found to be complying at a good level of GMP compliance at
Previous decision(s) Deferred for the submission of following (M-256):-
 Differential fee not attached.
 Calculations as base not provided.
 Complete description required to be submitted in reference to
innovator.
 Demanded price of the firm is not as per formulation.
 Dosage and indications are not as per the innovator.
 Manufacturing method is not complete.
 Commitment as per the decision of RB not provided.
 Composition is not as per the innovator.
 Documents are not signed by the technical staff.
 Finished product specifications are not provided.
 Fresh Inspection report not attached
 Details of HVAC & water treatment system not attached.
Registration Board deferred the case for consideration on its
turn. (M-285)
Evaluation by PEC The firm has submitted differential fee of Rs. 12000/-, (Deposit
slip#0760287) dated 09-08-2018.
Demanded price of the firm is ―As per PRC‖.
Commitments as per 251st meeting have been submitted.
Documents are signed by the technical staff.
The firm has claimed the priority consideration in lieu of
Export facilitation. The details of priority molecules were
provided by Reg-I vide letter No.F.7-7/2017-Reg-II (Vol-II).
Decision: Approved.
1751. Name and address of manufacturer / M/s Hoover Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength G-Pas Powder Sachet
Composition Dy. No.5997; 13-06-2017; Rs.20,000/- (13-06-2017)
Diary No. Date of R& I & fee Each sachet contains:
Mebeverine HCl….135mg
Ispaghula Husk……..3.5gm
Pharmacological Group Laxative and antispasmodic
Type of Form Form-5

Finished product Specification Manufacturer‘s Specification
30‘s; As per SRO
Approval status of product in Fybogel (MHRA)
Me-too status Husk-M by M/s. Genix
GMP status Last inspection report 20-1-2017 Panel recommended the grant
of additional section.
Previous decision(s) Deferred for clarification as Reference Regulatory Authority
product is present as granules for oral suspension (M-274).
Evaluation by PEC The firm has submitted that there may be typographic error in
the drafting of product in the agenda of 274th meeting i.e.,
Ispaghula powder instead of ispaghula Husk. The firm has
submitted revised Form-5 with fee Challan of Rs.5,000/-
(Deposit slip#0748681) dated 29-08-2018.
1752. Name and address of manufacturer / M/s Venus Pharma, 23-km Multan road, Lahore
Applicant
Brand Name +Dosage Form + Strength CLARITHROVIN Tablets
Composition Each Film coated tablet contain:
Clarithromycin………..….500mg
Diary No. Date of R& I & fee 04.06.2010, Rs. 8,000/-, 05.11.2013, Rs. 12,000/- (Photocopy
attached)
Type of Form Form-5
Pack size & Demanded Price Rs. 398/10‘s
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status Klarinor 500 mg Tablets by M/s Nortech Pharmaceuticals (Pvt)
Ltd (Reg#077970)
GMP status The panel of inspectors dated 09-07-2018 recommends for
grant of GMP certificate for export purpose only.
Previous decision(s) Deferred for the submission of following: (M-261)
i. Inspection report
ii. Commitment as per decision of board
iii. Finished product specification are incomplete.
iv. Fee of Rs. 8000/- and 12000/- is Photocopy
Evaluation by PEC The firm has submitted revised Form-5 and master formulation
with fee challan of Rs. 5,000/- (Deposit slip#1934401) dated
26-04-2019.
Decision: Approved.
1753. Name and address of manufacturer / M/s Maxitech Pharma Pvt. Ltd., Plot No. E-178, SITE Super
Applicant Highway Phase II, Karachi.
Brand Name +Dosage Form + Strength Cyclomax-B 20mg Capsule
Piroxicam-Beta-Cyclodextrin……….20mg
Diary No. Date of R& I & fee Dy.1339, 28-11-2016, Rs.20,000/-
Type of Form Form-5
Approval status of product in FELDENE 20mg CAPSULES by Pfizer Limited.

Me-too status FELDEN 20MG CAP by Pfizer Karachi. (Reg#006349)
compliance to GMP.
Previous decision(s) Deferred as reference product contains piroxicam base only
(M-264).
with correct salt form as below:
Piroxicam…………….20mg
Fee challan of Rs.5,000/- (Deposit slip # 0848058) dated 04-
02-2019 has been submitted.
Decision: Registration Board approved with innovator‘s specifications and revised formulation as
below:
Piroxicam…………….20mg
1754. Name and address of manufacturer / M/s Maxitech Pharma Pvt. Ltd., Plot No. E-178, SITE Super
Applicant Highway Phase II, Karachi.
Brand Name +Dosage Form + Strength Dimed-S Lotion 0.05% + 3%
Betamethasone dipropionate……0.05%
Salicylic Acid………………….3%
Diary No. Date of R& I & fee Dy. No. 1192, 24-11-2016, Rs.20,000/-
Pharmacological Group Anti-inflammatory / Antipruritic
Type of Form Form-5
As per PRC
Approval status of product in Diprosalic lotion by Schering-Plough (Canada)
Me-too status Betasalic by Atco
compliance to GMP.
Previous decision(s) Deferred as reference product contains piroxicam base only
(M-264).
Evaluation by PEC The firm has revised the strength of formulation as below:
Each ml contains:
Betamethasone Dipropionate……0.05%
International availability: Diprosalic Scalp application
0.05%w/w / 2%w/w cutaneous solution by Merck UK (MHRA
Approved)
Me-too status: Provate-S Lotion by Saffron (Reg# 060354)
Fee challan of Rs.5,000/- (Deposit slip # 0848059) dated 04-
02-2019 and Rs.15,000/- (Deposit Slip # 1936828) dated 13-
05-2019.
Decision: Registration Board approved with innovator‘s specifications and revised formulation as
below:
Each ml contains:
Betamethasone Dipropionate……0.05%
1755. Name and address of manufacturer / M/s Genome Pharmaceuticals (Pvt.) Ltd, Plot # 16/I-phase IV,
Applicant Industrial Estate Hattar, KPK
Brand Name +Dosage Form + Strength Clarinom 250mg Dry Suspension
Clarithromycin (as granules)…………250mg
Diary No. Date of R& I & fee Dy No. 667, 16-7-2012, Rs.8000/-, Rs.12,000/-, 26-11-2014
Type of Form Form-5
Pack size & Demanded Price 60ml; As Per SRO
Approval status of product in Clarithromycin 250 mg/5ml suspension (MHRA approved)
Me-too status Malacin DS 250mg by M/s Bosh Pakistan
GMP status GMP inspection conducted on 12-05-2018 showed good level
of compliance.
Previous remarks of the Evaluator. Source of Granules: M/s Surge Pharma
Previous decision(s) Deferred for clarification of Dissolution test of Clarithromycin
taste masked coated granules in acidic medium i.e 0.1N HCl as
FDA dissolution database recommends dissolution of
Clarithromycin suspension in phosphate buffer only (M-265).
Evaluation by PEC The firm has submitted that
―Clarithromycin for oral suspension is mentioned in official
monograph of USP, and USP has not described the dissolution
test for Clarithromycin Dry suspension. The dissolution test of
clarithromycin granule is in-house test according to USFDA
dissolution database. Updated specifications, analytical method
and USP monograph has been attached.‖
Decision: Approved.
1756. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals, Plot # 122, Block-A, Phase-V
Applicant Hattar Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Hi-Mine 4mg Tablet
Composition Each Film coated Tablet Contains:
Galantamine as Hydrobromide…………..4mg
Pharmacological Group Anticholinesterase
Type of Form Form-5
As per SRO
Me-too status Reminyl 4mg Tablet by Janssen-Cilag Pharma
concludes that keeping in view of overall GMP compliance, the
panel recommends the Renewal of DML.
Previous remarks of the Evaluator.  Reference product is uncoated tablet while applied
formulation is film coated tablet. Clarification /Revision of
Form-5 is required.
Previous decision(s) Deferred for revision of formulation as per reference product
formulation (M-278).
Evaluation by PEC The approval status of applied formulation with film coating
has been confirmed in MHRA
―Reminyl 4mg Film coated tablet.‖
Decision: Approved.
1757. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd, 30th Kilometer, Multan Road,
Applicant P.O. Box 399, Lahore, Pakistan
Brand Name +Dosage Form + Strength TAMOXIDEX 10mg TABLET
Tamoxifen citrate equivalent to Tamoxifen………10mg

Pharmacological Group Anti-Oestrogens, hormone antagonist
Type of Form Form 5
Approval status of product in Nolvadex Tablet of Astrazeneca (USFDA approved)
Me-too status Tamoxifen Sandoz 10mg Tablet by Novartis Pharma (Reg
no.047670)
GMP status The firm was granted GMP certificate based on inspection
Previous decision(s) Deferred for confirmation of requisite section for the applied
product with reference to decision of 286th meeting of
Registration Board regarding ―Manufacturing facility for
steroidal and non-steroidal hormones‖ (M-288).
Evaluation by PEC The firm has submitted that the applied product is Non-
steroidal Antiestrogen.
Registration Board approved registration of product in general
manufacturing areas with condition that manufacturer shall
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
1758. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd, 30th Kilometer, Multan Road,
Applicant P.O. Box 399, Lahore, Pakistan
Brand Name +Dosage Form + Strength TAMOXIDEX 20mg TABLET
Tamoxifen citrate equivalent to Tamoxifen………20mg
Pharmacological Group Anti-Oestrogens, hormone antagonist
Type of Form Form 5
Approval status of product in Nolvadex Tablet of Astrazeneca (USFDA approved)
Me-too status Tamoxifen Sandoz 20mg Tablet by Novartis Pharma (Reg
no.047671)
Previous decision(s) Deferred for confirmation of requisite section for the applied
product with reference to decision of 286th meeting of
Registration Board regarding ―Manufacturing facility for
steroidal and non-steroidal hormones‖ (M-288).
Evaluation by PEC The firm has submitted that the applied product is Non-
steroidal Antiestrogen.
Registration Board approved registration of product in general
manufacturing areas with condition that manufacturer shall
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and

1759. Name and address of manufacturer / M/s Getz Pharma (Pvt) Limited, 29-30-Sector 27, Korangi,
Brand Name +Dosage Form + Strength TREVIAMET XR Tablets
Sitagliptin as Phosphate monohydrate……….100mg
Metformin Hydrochloride……………………1000mg
Diary No. Date of R& I & fee Dy. No 1803 dated 14-12-2012, 50,000 dated 12-12-2012
Pharmacological Group DPP-4 & Biguanide
Pack size & Demanded Price Rs. 169 /- per tablet/ Pack of 14‘s & 30‘s
Approval status of product in Janumet XR (USFDA approved)
Me-too status Tagipmet XR 100/1000mg by M/s Highnoon
dated 16-02-2018.
Previous decision(s) Deferred for submission of laboratory scale scientifically
rational stability data as per requirements decided in the 251st
meeting of Registration Board (M-257).
Evaluation by PEC The firm has submitted that the subject product is the line
extension of our already registered and marketed products
―Treviamet XR Tablets 50mg + 500mg (Reg#085938) and
―Treviamet XR Tablets 50mg + 1000mg (Reg#085939)‖.
Treviamet XR Tablets 100mg + 1000mg is dose proportional
to our other registered strengths as well as the qualitative
composition, manufacturing process and testing procedure is
same as that of Treviamet XR Tablets 50mg + 500mg & 50mg
+ 1000mg.
Decision: Deferred for submission of stability data as per requirements decided in the 278 th meeting
of Registration Board.
1760. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot#: 25 & 26,
Applicant Street#S-3, RCCI, National Industrial Zone,Rawat, Islamabad.
Brand Name +Dosage Form + Strength Epirom Injection 500mg
Cefpirome Sulphate (with sodium carbonate)…….500mg
Pharmacological Group Cephalosporin (Antibiotics)
Type of Form Form-5
Me-too status Pirome Injection 500mg of Cirin Pharmaceuticals
GMP status New License (Inspection Date: 07th June 2017)
Previous remarks of the Evaluator. The applied formulation is repealed in ANSM and it is not
found in other reference agencies.
Previous decision(s) Deferred for evidence of approval of applied formulation in
declared/approved by the Registration Board (M-278).
Evaluation by PEC The approval status of applied formulation has been confirmed
in ANSM.
1761. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25 & 26,
Applicant Street#S-3, RCCI, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Epirom Injection 1gm

Cefpirome Sulphate (with sodium carbonate)..........1gm
Diary No. Date of R& I & fee DyNo.14232; 07-09-2017; Rs. 20,000/-
Pharmacological Group Cephalosporin (Antibiotics)
Type of Form Form-5
Me-too status Pirome Injection 1gm of Cirin Pharmaceuticals
GMP status New License (Inspection Date: 07th June 2017)
Previous remarks of the Evaluator. The applied formulation is repealed in ANSM and it is not
found in other reference agencies.
declared/approved by the Registration Board (M-278).
in ANSM.
1762. Name and address of manufacturer / M/s. Remedy Pharmaceuticals (Pvt) Ltd. Lahore
Brand Name +Dosage Form + Strength Opizole 40mg Injection
Omeprazole Sodium (Lyophilized) eq. to
Omeprazole……….…40mg
Type of Form Form-5
Approval status of product in Omeprazole IV 40mg Injection of sandoz (TGA)
Me-too status Risek 40mg injection by Getz Pharma
GMP status GMP certificate of M/s English Pharmaceuticals issued on the
basis of inspection conducted on 26-01-2018.
Previous decision(s) Secretary RB apprised the Board that firm has changed their
name to M/s A‘raf Pharmaceuticals Lahore.
The Board deferred the case for clarification regarding name of
the firm (M-265).
Evaluation by PEC The firm has submitted document of licensing division dated
11th November, 2013 for change of name of company to ―M/s
A‘raf (Pvt) Ltd, 23-Km, Raiwind Road, Lahore (DML
No.00685)‖.
GMP status of M/s A‘raf (Pvt) Ltd could not be verified.
Decision: Deferred for submission of GMP status of ―M/s A‘raf (Pvt) Ltd, 23-Km, Raiwind Road,
Lahore (DML No.00685)‖ and number of products already approved in contract manufacturing
and details of section approved by CLB.
1763. Name and address of manufacturer / M/s. Remedy Pharmaceuticals (Pvt) Ltd. Lahore
Brand Name +Dosage Form + Strength Piprazo 4.50gm Injection
Sterile Piperacillin Sodium eq. to Piperacillin ………….4.0gm
Sterile Tazobactam Sodium eq. to Tazobactam
…………0.50gm
Pharmacological Group Penicillin antibiotic
Type of Form Form-5
Approval status of product in Piperacillin Tazobactum by Sandoz (MHRA Approved)
Me-too status Tazocin 4.5gm by Wyeth Ltd
GMP status GMP certificate of M/s English Pharmaceuticals issued on the
basis of inspection conducted on 26-01-2018.
Previous decision(s) Secretary RB apprised the Board that firm has changed their
name to M/s A‘raf Pharmaceuticals Lahore.
The Board deferred the case for clarification regarding name of
the firm (M-265).
Evaluation by PEC The firm has submitted document of licensing division dated
11th November, 2013 for change of name of company to ―M/s
A‘raf (Pvt) Ltd, 23-Km, Raiwind Road, Lahore (DML
No.00685)‖.
GMP status of M/s A‘raf (Pvt) Ltd could not be verified.
Decision: Deferred for submission of GMP status of ―M/s A‘raf (Pvt) Ltd, 23-Km, Raiwind Road,
Lahore (DML No.00685)‖ and number of products already approved in contract manufacturing
and details of section approved by CLB.
1764. Name and address of manufacturer / M/s Innvotek Pharmaceuticals, Plot No. 35, Industrial Triangle,
Brand Name +Dosage Form + Strength Trend ophthalmic suspension
Neomycin (as sulphate)……………….3500 IU
Dexamethasone…….………….……….1 mg
Polymixin B sulphate…….……..…….6000 IU
Diary No. Date of R& I & fee Dy.No.124;(08-11-2016);Rs.20,000/-(08-11-2016)
Pharmacological Group Steroid, antibacterial agent
Type of Form Form-5
Approval status of product in Maxitrol ophthalmic suspension (MHRA approved)
Me-too status Max-ND ophthalmic solution of M/s Polyfine Chempharma
GMP status Last GMP inspection conducted on 09-03-2017 and the
report concludes that viewing the facts the company is
following the GMP guidelines as of today.
Previous remarks of the Evaluator. The reference of me-too drug provided by the firm Maxitrol
eye drops of M/s Novartis also contains
 Hypromellose ……………..0.5% as active
 Neomycin (as sulphate)……………….3500 IU
 Dexamethasone…….………………….1 mg
 Polymixin B sulphate…….……..…….6000 IU
Previous decision(s) Deferred for confirmation of hypermellose and solution /
suspension in reference regulatory authorities (M-277).
Deferred for further deliberation in view of reference product
(M-287).
Evaluation by PEC The firm has submitted that Hypermellose is not mentioned as
active in label claim approved by Reference regulatory
authorities and it is considered only as an excipient.

The dosage form of reference product is in ophthalmic
suspension.
The firm has referred USP reference monograph of product is
an ophthalmic suspension stating neomycin, polymyxin B
Sulfate and dexamethasone as an active. Hypromellose is also
not mentioned as API in any monograph of official
compendium.
Decision: Registration Board deferred the case for further deliberation in view of reference
product.
1765. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot No. 31, 32, Punjab Small
Applicant Industrial Estate, Taxilla.
Brand Name +Dosage Form + Strength Wenoxime 200mg Capsules
Cefixime…………………200mg
Diary No. Date of R& I & fee Dy.No.8899, 17-01-2014, Rs.20,000/-, 17-01-2014
Pharmacological Group Cephalosporin antibiotic
Pack size & Demanded Price 1 × 5‘s; As per SRO
Approval status of product in Spanish Agency of Medicines and Health Products
Me-too status Suprax by Lupin Pharma Icef Capsule by ICI
GMP status Last GMP inspection was conducted on 30-09-2018 & 29-10-
2018 and the report concludes that firm is GMP compliant with
need of some improvements and the panel recommends grant
of GMP certificate.
Previous decision(s) Deferred for confirmation of international availability in
reference regulatory Authorities (M-243 & M-250).
in Spanish Agency of Medicines and Health Products.
Decision: Approved.
1766. Name and address of manufacturer / M/s Medicraft Pharmaceuticals (Pvt) Ltd, 126-B, Industrial
Applicant Estate, Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Vit.D 5mg/ml Injection
Cholecalciferol (200,000I.U).................5mg
Diary No. Date of R& I & fee Rs. 40,000/- (Duplicate Dossier)
Type of Form Form-5
Finished product Specification BP Spec‘s
Pack size & Demanded Price 1ml x 5‘s
Approval status of product in Vitamin D3 Good 200,000IU / 1 ml solution for injection of
Reference Regulatory Authorities. (ANSM France approved)
Me-too status Calciferol Injection M/s Global Pharmaceuticals
GMP status Last GMP inspection conducted on 30-01-2018 and report
concludes that firm may be considered to be operative in Good
level of cGMP Compliance.
a. Revised Form-5 is submitted with following label claim:
Each ml contains:
Cholecalciferol………..5mg eq. to 250000 IU
b. Clarification is required regarding calculation of 5mg eq. to
250000IU.
c. Quantity of API submitted in master formulation is not
rational with label claim.
d. Reference of calcitrol (1mcg/ml) injection is given under
evidence of availability in reference agencies and Pakistan.
Evaluation by PEC The firm has submitted revised Form-5 with fee challan of Rs.
5,000/- (Deposit slip#0802855) dated 09-01-2019.
Differential fee is required to be submitted.
Decision: Deferred for submission of differential fee for revision of formulation.
1767. Name and address of manufacturer / M/s Medicraft Pharmaceuticals (Pvt) Ltd, 126-B, Industrial
Applicant Estate, Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Go-Spa Injection 40mg/ 2ml
Composition Each 2ml ampoule ontains:-
Drotaverine HCl………..…40mg
Pharmacological Group Anti-Spasmodic
Type of Form Form-5
Finished product Specification in house specification
Pack size & Demanded Price 25x2ml, As per SRO
Approval status of product in Not provided
Me-too status No-Spa by Sanofi- Aventis
report concludes:
―The firm MAY BE considered to be operative in
GOOD level of cGMP compliance. However, it was an old
facility, over space is limited, workload is heavy due to heavy
production of for local and export purposes. The firm should
plan for modification and/ or shifting to wide area in future.
They were also advised to arrange more fire-extinguishers and
improve emergency exits in the building. They should also
make a direct connection with fire brigade and install smoke
detectors.
Previous remarks of the Evaluator. Inspection report includes many observations.
The applied drug couldn‘t be searched in the reference
declared/approved by Registration Board in 275th meeting (M-
279).
Evaluation by PEC Following reference for drotaverine 40mg/2ml injection in
three European countries along with reference weblink.
1. NO-SPA 40 mg solution for injection by Sanofi Aventis

(OGYEI Hungary Approved)
(Link:https://www.ogyei.gov.hu/gyogyszeradatbazis/index.php
?action=show_details&item=11235)
Date of access: 09-11-2018
2. NO-SPA 40 mg / 2 ml solution for injection by Sanofi
Romania (NAMMD Romania Approved)
(Link:https://www.anm.ro/_/_RCP/RCP_6973_10.10.14.pdf)
3. No-Spa 20 mg/ml solution for injection by Chinoin

Pharmaceutical and Chemical Works Co. Ltd (Executive
Agency For Medicinal Products, Bulgaria Approved)
(Link:http://www.bda.bg/images/stories/documents/register/dru
gs/details/lf2120.htm)
1768. Name and address of manufacturer / M/s NovaMed Pharmaceuticals Pvt. Ltd., 28-Km Ferozepur
Applicant Road, Lahore
Brand Name +Dosage Form + Strength Vitamol-F Tablets
Composition Each Tablet contains:-
Paracetamol …………….650mg
Orphenadrine Citrate ……50mg
Diary No. Date of R& I & fee Dy No. 806: 21-09-2015
PKR 20,000/-: 21-09-2015
Pharmacological Group Analgesic and muscle relaxant
Type of Form Form 5
Me-too status Nuberol Forte by Searle
GMP status GMP inspection dated 22-01-2019 concluded that the firm
was considered to be operating at GOOD level of compliance
with GMP guidelines.
Previous remarks of the Evaluator.  Latest GMP inspection report (which should have been
conducted within the period of last one year)
regulatory authorities which were approved by Registration
Board in its 249th meeting
Previous decision(s) Deferred for following submission (M-273)
 GMP inspection report conducted within a period of last 1
year.
 Evidence of approval by reference regulatory authorities
Evaluation by PEC The firm has revised formulation with submission of fee
challan of Rs.20,000/- (Deposit slip # 1900994) dated 27-03-
2019. The new formulation is as below:
Each tablet contains:-
International availability: Norgesic 35mg/ 450mg uncoated
tablet of M/s iNova Pharmaceuticals, Approved in (TGA)
Australia
Me-too status: Gloral tablet of M/s Global Pharmaceuticals
(Reg # 066681).
Decision: Approved with innovator‘s specifications and with following revision:
1769. Name and address of manufacturer / M/s EG Pharmaceutical, Plot No. 13-A, Industrial Triangle,
Brand Name +Dosage Form + Strength TIZAREX Tablet 2mg
Tizanidine as hydrochloride..………2mg
Pharmacological Group Skeletal Muscle relaxant
ATC Code: M03BX02
Type of Form Form 5
Pack size & Demanded Price 1 x 10‘s ; As per SRO
Approval status of product in Tizanidine 2mg Tablet of Teva, UK (MHRA approved)
Me-too status Tandolax 2mg Tablet M/s High-Q Pharmaceuticals
GMP status GMP inspection conducted on 28-08-2018 & 03-09-2018
concluded that M/s EG Pharma may be considered to be
operating in compliance with GMP guidelines as per Drugs
Act, 1976 and rules framed thereunder.
Previous remarks of the Evaluator. Salt form of applied formulation is not mentioned in Form-5.
Clarification is required.
Previous decision(s) Deferred for revision of formulation with salt form of API as
per reference product along with submission of requisite fee for
change of formulation (M-287).
Evaluation by PEC The firm has submitted revised Form-5 with correct salt form
and deposited fee challan of Rs.5,000/- (Deposit slip#0717200)
dated 18-03-2019.
Decision: Approved.
Brand Name +Dosage Form + Strength DELORTA TABLET 5mg
Desloratadine……………5mg
Type of Form Form-5
Me-too status Desdine 5mg Tablet of M/s Hygeia Pharmaceuticals,
Islamabad (Reg.# 080821)
GMP status As recoded for above application
Evaluation by PEC The firm has submitted revised Form-5 from uncoated to Film
coated tablet and deposited fee challan of Rs.5,000/- (Deposit
slip#0717199) dated 18-03-2019.
Brand Name +Dosage Form + Strength PITAVA 2MG TABLET
Pitavastatin as calcium ……………2mg
Type of Form Form-5
Pack size & Demanded Price 1x10‘s, As per SRO
Me-too status PITALO 2mg Tablet of GENIX PHARMA
Previous remarks of the Evaluator. Salt form of API is not mentioned in label claim.
Clarification/correction is required.
Previous decision(s) Deferred for revision of formulation with salt form of API as
per reference product along with submission of requisite fee for
change of formulation (M-287).
with fee challan of Rs.5,000/- (Deposit slip#0505697) dated

18-03-2019.
Brand Name +Dosage Form + Strength SIGLIP TABLETS 50/1000MG
Sitagliptin as phosphate monhydrate……50mg
Metformin Hydrochloride……….1000mg
Type of Form Form-5
Pack size & Demanded Price 14‘s/ As per policy of DRAP.
Approval status of product in ARTG ID: 149023; JANUMET 50mg/1000mg film-coated
Reference Regulatory Authorities. tablet by M/s Merck Sharp & Dohme (Australia) Pty Ltd
Approved in TGA.
Me-too status Neoglip 50/1000mg Tablets of M/s Atco Lab (Reg#053100)
 Revision of formulation with salt form of API as per
reference product along with submission of requisite fee for
change of formulation.
 Submision of enclosures of Form-5
Evaluation by PEC The firm has submitted revised formulation as per reference
18-03-2019.
Brand Name +Dosage Form + Strength Monticast 5mg Chewable tablet
Composition Each chewable tablet contains:
Montelukast as Sodium …..5mg
Pharmacological Group Leukotriene receptor antagonist
Pack size & Demanded Price 1x 14‘s & as per SRO
Me-too status Monty 10mg tablets of M/s Leads Pharma (Reg. # 050965)
Previous remarks of the Evaluator. Details of enclosures of Form-5 are missing. Revised Form-5 is
required.
 Master formulation shows film coating while reference
product is chewable tablet. Clarification is required.
18-03-2019.
Decision: Approved.
Brand Name +Dosage Form + Strength DENSETRON INJECTION 8MG/4ML (IM/IV)

Ondansetron as hydrochloride dihydrate………8mg
Pharmacological Group Antiemetic; Serotonin (5HT3) antagonists
ATC Code: A04AA01
Type of Form Form-5
Pack size & Demanded Price 1x10‘s, As per SRO
Me-too status Ondansetron –Sandoz 8mg / 4ml solution for injection of M/s
Novartis (Reg#066121)
Previous remarks of the Evaluator. Salt form of API is not mentioned in Form-5. Revised Form-5
is required.
18-03-2019.
Decision: Approved.
1775. Name and address of manufacturer / M/s Welwrd Pharmaceuticals, Plot No.3, Block I-II, Industrial
Applicant Estate, hattar
Brand Name +Dosage Form + Strength Artiwel 120mg Injection
Artesunate……………120mg
Type of Form Form-5
Pack size & Demanded Price 1 vial with relevant solvent (WFI or Lignocaine); As per policy
of MOH
Approval status of product in WHO prequalified formulation
Me-too status Gen-M Injection 120mg of M/s Genix (Reg. # 076073)
GMP status GMP inspection conducted on 12-11-2018 concluded that the
firm is operating at satisfactory level of GMP.
Previous decision(s) Deferred for clarification of diluent for applied formulation.
Moreover Registration Board directed the firm to submit
separate applications for registration of diluents (M-287).
Evaluation by PEC The firm has submitted that
―We have wrongly mentioned in formulation. Our firm has
separately applied for sodium bicarbonate 5% as a solvent.‖
Decision: Approved with international pharmacopoeia specifications.
1776. Name and address of manufacturer / M/s Akson Pharmaceuticals Pvt Ltd, Plot # 9-B/1&2, Old
Applicant Industrial Estate, Sector D 1, Mirpur Azad Kashmir.
Brand Name +Dosage Form + Strength Clomison Tablet 50mg
Clomiphene Citrate….………..50mg
Diary No. Date of R& I & fee Diary No. 6143, 24-09-2013, Rs.20,000/-.
Pharmacological Group Ovulatory stimulant
Type of Form Form-5

Approval status of product in Clomid 50mg Tablets by M/s Sanofi , (MHRA approved)
Me-too status Ovafin 50 mg tablet by M/s OBS (Reg#019173)
GMP status Last inspection of Akson Pharmaceuticals was conducted on
16-06-2017 & 25-07-2017 for renewal of DML and panel
recommended for renewal of DML.
Previous decision(s) Deferred till decision on manufacturing requirement for
clomiphene (M-259).
Evaluation by PEC
Decision: Registration Board decided to approve registration of applied product in general
manufacturing areas with condition that manufacturer shall provide safety and protective
measures for workers and personnel which remain in direct contact or are involved in close
1777. Name and address of manufacturer / M/s Pearl Pharmaceuticals, Plot No.204, Street No.1, I-10/3
Applicant industrial Area, Islamabad
Brand Name +Dosage Form + Strength Trolim Ointment
Tacrolimus as monohydrate……….….. 0.03% w/w
Diary No. Date of R& I & fee Dy.No.2694, 17-01-2011, Rs.8,000/-, 17-01-2011 Rs.12,000/-,
13-04-2015
Pharmacological Group Immunomodulator
Type of Form Form-5
Pack size & Demanded Price 10gm, Rs.325.00
Approval status of product in Protopic 0.03% w/w ointment by M/s Astellas Ireland Co. Ltd
Reference Regulatory Authorities. (Netherlands Approved),
Me-too status Eczemus 0.03% Ointment by M/s Brookes Pharma
(Reg#045494)
GMP status GMP inspection dated 23-07-2018 concluded that the firm was
found in satisfactory compliance with GMP guidelines.
Previous decision(s) Deferred for evidence of approval by reference regulatory
authorities for decision regarding requirement of
manufacturing facility for Tacrolimus (M-268).
Evaluation by PEC  Firm has Cream/Ointment (Steroid, Non-Steroid)
Section.
 Approval status has been confirmed in
Netherlands.
 Registration Board decided to grant registration of
above applied products in general manufacturing areas with
condition that manufacturer shall provide safety and
protective measures for workers and personnel which remain
in direct contact or are involved in close handling of these
drugs.
Decision: Registration Board decided to approve registration of applied formulation in general
manufacturing areas with condition that manufacturer shall provide safety and protective
measures for workers and personnel which remain in direct contact or are involved in close
1778. Name and address of manufacturer / M/s Linta Pharmaceuticals (Pvt) Limited, Plot # 3, Street no. S-
Applicant 5, National Industrial Zone Rawat, Islamabad
Brand Name +Dosage Form + Strength Spix tablet 80mg/ 80mg
Phloroglucinol Dihydrate ..…………................80mg
Trimethylphloroglucinol………………………80mg
Pharmacological Group Antispasmodics
Type of Form Form-5
Pack size & Demanded Price 3x10‘s & as per DRAP policy
Approval status of product in Approved by ANSM of France
Me-too status Spadix 80mg/80mg tablets of M/s Tabros Pharma
report concludes firm may be issued GMP certificate.
Previous decision(s) Deferred for clarification of dosage form since reference
product is available as sugar coated tablet whereas firm has
applied for film coated tablet (M-279).
Deferred for submission of fee for revision of formulation (M-
283).
Evaluation by PEC The firm has submitted revised Form-5 with sugar coating in
label claim and master formulation in line with reference
country:
Each sugar-coated tablet contains:
Phloroglucinol Dihydrate.…………................80mg
The firm has deposited fee challan of Rs. 5,000/- (Deposit
slip#0818783) dated 31-12-2018.
Each sugar-coated tablet contains:
Phloroglucinol Dihydrate.……………………..80mg
1779. Name and address of manufacturer / M/s. Fynk Pharmaceuticals, 19-Km, Ferozepur Road, G.T.
Applicant Road, Kala shah Kaku, Lahore.
Brand Name +Dosage Form + Strength Bucaine Injection
Bupivacaine hydrochloride.………….7.5mg
Pharmacological Group Local anesthetic agent
Type of Form Form-5
Pack size & Demanded Price 2ml × 5‘s, 10‘s, 100‘s; As per PRC
Approval status of product in Bupivacaine hydrochloride 15mg/2ml Injection of Aurobindo
Reference Regulatory Authorities. Pharms (Health Canada)
Me-too status Bucane Injection 7.5mg/ml of ophth Pharma (Reg#042023)
GMP status GMP inspection on 20-09-2017 concluded that overall
condition of the firm is satisfactory.
reference regulatory authorities/agencies which were adopted
by the Registration Board in its 275th meeting.
registration number, brand name and name of firm. (M-284).
Deferred for submission of differential fee of Rs. 15,000/- for
change of formulation. (M-287)
with fee challan of Rs. 5000/- (deposit slip # 0771779) dated
18-12-2018. The correct formulation is as below:
Each 2ml ampoule contains:
Bupivacaine hydrochloride.………….15mg
The firm has submitted differential fee of Rs. 15,000/- (deposit
slip # 0841315) dated 21-02-2019 for revision of formulation.
Each 2ml ampoule contains:
Bupivacaine hydrochloride.………….15mg
1780. Name and address of manufacturer / M/s. Fynk Pharmaceuticals, 19-Km, Ferozepur Road, G.T.
Applicant Road, Kala shah Kaku, Lahore.
Brand Name +Dosage Form + Strength Fosmin Gel
Composition Each gram Contains:-
Isotretinoin.………………..0.05% w/w
Diary No. Date of R& I & fee R&I 1381, 04-03-2015, Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price As per SRO/10gm
Approval status of product in Isotrex Gel 0.05% by M/s Stiefel Laboratories (MHRA
Reference Regulatory Authorities. approved)
Me-too status Iso Scot Gel 0.05% of M/s Scotman Pharma
GMP status GMP inspection on 20-09-2017 concluded that overall
condition of the firm is satisfactory.
Previous decision(s) Deferred for confirmation of approval by Reference Regulatory
authorities / countries (M-257).
for change of formulation from cream to gel.
The firm has deposited fee challan of Rs. 5,000/- (deposit slip #
0841316) dated 21-02-2019 and fee challan of Rs. 15,000/-
1781. Name and address of manufacturer / M/s. Cibex (Private) Ltd., F-405, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Strength Cibcos-R Syrup
Acefylline Piperazine……….…45mg
Diphenhydramine……………..…8mg
Diary No. Date of R& I & fee Dy. No. 607, 30-04-2014, Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price As per SRO/60ml, 120ml
Me-too status Acelyf Syrup of M/s Hicon Pharma
GMP status GMP Inspection of Cibex Pvt. Ltd conducted on 29-08-2017
with showed conclusive remarks of satisfactory level of cGMP
compliance.
Previous decision(s) Deferred for review of formulation by the Review Committee
(M-245).
Evaluation by PEC The firm has submitted that for cough preparation, condition of
SRA has been waived.
1782. Name and address of manufacturer / M/s Winthrox Laboratories (Private) Limited, Karachi
Applicant
Brand Name +Dosage Form + Strength Wincip 250mg/5ml Granules for Oral Suspension.
Composition Dy. No. 504 dated 21-09-2015, Rs: 20,000/-
Diary No. Date of R& I & fee Each 5ml of reconstituted suspension contains:

Ciprofloxacin………….…..250 mg
Granules:-
Each 100mg Granules contains 22.5mg of Ciprofloxacin base.
Solvent/Diluent:
Soya lecithin, Medium chain triglycerides, Strawberry flavor,
Sugar (Granular), Purified water.
Type of Form Form-5
Finished product Specification Manufacture Specification
Pack size & Demanded Price Pack size of 60 ml / as per price fixed by Government.
Approval status of product in Ciproxin-USFDA approved
Me-too status Hiflox (Hilton)
GMP status Oral Dry Powder Suspension (General) & Liquid Syrup
(General) granted in 239th meeting of Central Licensing Board.
Previous remarks of the Evaluator. --.
Previous decision(s) Deferred for verification of composition of diluents in
Registration Board (M-255).
Registration Board deferred the case as per decision of 269 th
meeting regarding formulation of ―ciprofloxacin 125mg/5ml
granules and solvent for oral suspension‖. Wherein
Registration Board was apprised that already registered
products were either not providing diluent with the
ciprofloxacin suspension or the composition of diluent was not
as per the reference product. Registration Board advised
Pharmaceutical Evaluation Cell to prepare the case along with
details including manufacturing area requirements of the
solvent/diluent and considering the legal requirements for the
separate registration of the solvent for further deliberation in
Registration Board
(M-270).
Deferred for clarification of applied formulation since
reference product contains Ciprofloxacin as base only whereas
submitted source contains Ciprofloxacin as hydrochloride
granules (M-286).
Evaluation by PEC  Firm has submitted detailed composition of diluent as under:
Sr.# Raw Material Req. volume per
bottle
i. Soya lecithin 0.45g
ii. Medium chain 0.500
triglycerides
iii. Sugar (Granular) 3.31
iv. Strawberry flavor 0.669
v. Purified water q.s 40.0 ml
 The above stated composition is qualitatively identical to that
of reference product approved by USFDA.
 Source: M/s Vision Pharma
 The firm has submitted revised Form-5 and master
formulation with fee challan of of Rs. 5,000/- (Deposit
slip#0721179) dated 07-11-2018.
Decision: Approved. Diluent shall be as per innovator‘s composition.
1783. Name and address of manufacturer / M/s Winlet Pharma 30 Km, Laksian Lahore road. Sargodha
Applicant
Brand Name +Dosage Form + Strength Lorades 2.5 mg/5ml Syrup
Desloratadine …………0.5 mg
Diary No. Date of R& I & fee Dy No. 3414, 13-04-2018, Rs.20,000/-
Type of Form Form-5
Finished product Specification Manufacturer
Approval status of product in Clarinex syrup by Merck Sharp Dohm (USFDA Approved)
Me-too status Neo-Antial syrup by Sami Pharma
GMP status New DML granted Inspection Date 05/12/2017
by the Registration Board in its 275th meeting (M-282).
Deferred for submission of 20,000/- fee for revision of applied
strength (M-288).
Evaluation by PEC The firm has submitted revised Form-5 as per reference
formulation with following details:
Each 5 ml contains:
Desloratadine ……………..2.5 mg
International availability: Clarinex syrup by Merck Sharp
Dohm (USFDA Approved)
Me-too status: (Neo-antial syrup by Sami Pharma)
Fee of 5000/-, challan # 0814955, dated: 31/12/2018 was
submitted.
The firm has submitted differential fee of Rs. 15,000/- (Deposit
slip # 1916637) dated 09-05-2019.
1784. Name and address of manufacturer / M/s Winlet Pharma 30 Km, Laksian Lahore road. Sargodha
Applicant
Brand Name +Dosage Form + Strength Famole 40 mg/5ml Dry Suspension
Famotidine ....................10 mg
Diary No. Date of R& I & fee Dy No. 3417, 13-04-2018, Rs.20,000/-
Type of Form Form-5
Approval status of product in Pepcid 40 mg/5 ml for suspension of Salix Pharma Inc., USA
Reference Regulatory Authorities. (USFDA approved)
Me-too status Pepnex 40mg/5ml Dry Powder Suspension of M/s Nexus
Pharma
GMP status New DML granted Inspection Date 05/12/2017
Previous remarks of the Evaluator. Not approved by reference drug regulatory agencies.
Internationally available formulation is dry powder for
suspension in the strength of 40 mg/ 5 ml.(Ref: US FDA)
by the Registration Board in its 275th meeting (M-282).
Deferred for submission of 20,000/- fee for revision of applied
strength (M-288).
Evaluation by PEC The firm has submitted revised Form-5 as per reference
formulation with following details:
Each 5 ml contains:
Famotidine ……..........40 mg
International: (Pepcid 40 mg/5 ml of Salix Pharma Inc., USA
(USFDA approved)
Me-too status: (Pepnex 40mg/5ml Dry Powder Suspension of
M/s Nexus Pharma)
Fee of 5000/-, challan # 0814954, dated: 31/12/2018 was
submitted.
The firm has submitted differential fee of Rs. 15,000/- (Deposit
slip # 1916638) dated 09-05-2019.
Decision: Approved.
1785. Name and address of manufacturer / M/s Walt Danzay Pharmaceuticals, Plot No 35-A, Small
Applicant Industrial Estate, Taxila, Pakistan
Brand Name +Dosage Form + Strength WaltDul Capsule 30 mg
Enteric coated pellets of Duloxetine hydrochloride (17.5%)
equivalent to Duloxetine……………30mg
Diary No. Date of R& I & fee Dy No: 1396 : 03-05-2017 PKR 20,000/- : 03-05-2017
Pharmacological Group Selective Serotonin Reuptake Inhibitor (SSRI)
Type of Form Form 5
Finished product Specification -
Pack size & Demanded Price 14‘s
As Per SRO
Approval status of product in Cymbalta by Lilly
Me-too status Dulan by Hilton Pharma
GMP status Inspection report dated 15-02-2017, the panel recommended
the grant of drug manufacturing license
Previous remarks of the Evaluator. Firm has claimed in house specifications while the product is
present in USP
 Firm has not provided source, GMP, COA and stability data
of pellets
Previous decision(s) Deferred for following submissions (M-271)
 Real time and accelerated stability study data of 3
batches of pellets
Submission of same brand name for all strengths
Registration Board deferred for clarification as submitted
source of pellets is not of USP grade (M-275).
Registration Board deferred the case since submitted source of
pellets is not of USP grade (M-278).
Evaluation by PEC Firm has requested to change the source of pellets
(22.5%) to M/s Murli Krishna Pharma (Pvt) Ltd., along with
fee PKR 100,000/- (Chalan # 0726014).
copy of GMP certificate
25oC ± 2oC and 60% ± 5% RH which is not as per the

requirement of Zone IV-A.
to be tested at buffer stage
of either 20% or 32%, while the pellets of M/s Murli Krishna is
22.5%.
60 mins, while that provided in COA is NLT 70% of Q in 45

min.
New firm title is ―M/s. Horizon Healthcare (Pvt.) Ltd,
Taxila, Pakistan‖.
GMP certificate granted based on inspection conducted on 26-
01-2018.
The firm has submitted stability data sheet with revised storage
conditions of 30oC ± 2oC and 65% ± 5%RH while remaining
particulars i.e., batch numbers and results etc was the same.
The firm has submitted fresh dossier with new title of the firm
―M/s. Horizon Healthcare (Pvt.) Ltd, Taxila, Pakistan‖.
New fee challan of Rs. 20,000/- (deposit slip # 0817179) dated
05-12-2018 has been submitted.
Source of pellets: M/s Murli Krishna Pharma (Pvt) Ltd, India.
The firm has submitted revised COA from M/s Murli Krishna
Pharma (Pvt) Ltd, India with dissolution specifications same as
mentioned in USP.
Decision: Approved.
1786. Name and address of manufacturer / M/s Walt Danzay Pharmaceuticals, Plot No 35-A, Small
Applicant Industrial Estate, Taxila, Pakistan
Brand Name +Dosage Form + Strength DulaxWalt 60 mg Capsule
Composition Each capsule contains
Enteric coated pellets of Duloxetine hydrochloride (22.5%)
equivalent to Duloxetine……………60mg
Diary No. Date of R& I & fee Dy No: 3193 : 18-05-2017 PKR 20,000/- : 18-05-2017
Pharmacological Group Selective Serotonin Reuptake Inhibitor (SSRI)
Type of Form Form-5
Finished product Specification -
Pack size & Demanded Price 1 x 10‘s: As Per SRO
Approval status of product in Cymbalta by Lilly
Me-too status Dulan by Hilton Pharma
GMP status Inspection report dated 15-02-2017, the panel recommended
the grant of drug manufacturing license
Previous remarks of the Evaluator. Firm has claimed in house specifications while the product is
present in USP
 Firm has not provided source, GMP, COA and stability data of
pellets
 Firm has applied for different brand name for 30mg strength
of same drug
Previous decision(s) Deferred for following submissions (M-271).
 Real time and accelerated stability study data of 3
batches of pellets
Submission of same brand name for all strengths
Registration Board deferred for clarification as submitted
source of pellets is not of USP grade (M-275).
Evaluation by PEC Firm has requested to change the source of pellets
(22.5%) to M/s Murli Krishna Pharma (Pvt) Ltd., along with
fee PKR 100,000/- (Chalan # 0726014).
copy of GMP certificate
25oC ± 2 oC and 60% ± 5% RH which is not as per the

requirement of Zone IV-A.
of either 20% or 32%, while the pellets of M/s Murli Krishna is
22.5%.
60 mins, while that provided in COA is NLT 70% of Q in 45

min.
New firm title is ―M/s. Horizon Healthcare (Pvt.) Ltd,
Taxila, Pakistan‖.
GMP certificate granted based on inspection conducted on 26-
01-2018.
The firm has submitted stability data sheet with revised storage
conditions of 30oC ± 2 oC and 65% ± 5% while remaining
particulars i.e., batch numbers and results etc was the same.
The firm has submitted fresh dossier with new title of the firm
―M/s. Horizon Healthcare (Pvt.) Ltd, Taxila, Pakistan‖.
New fee challan of Rs. 20,000/- (deposit slip # 0817180) dated
05-12-2018 has been submitted.
Source of pellets: M/s Murli Krishna Pharma (Pvt) Ltd, India.
The firm has submitted revised COA from M/s Murli Krishna
Pharma (Pvt) Ltd, India with dissolution specifications same as
mentioned in USP.
Decision: Approved.
1787. Name and address of manufacturer / M/s ISIS Pharmaceuticals and chemicals 25/1-3 sector 12-C,
Applicant North Karachi industrial area, Karachi
Brand Name +Dosage Form + Strength Isaline 0.9% 100ml Infusion
Normal Saline…………….5% 100ml
Diary No. Date of R& I & fee Dy.No.1715, 30-8-2016, Rs.20,000/-
Pharmacological Group Electrolyte solution
Type of Form Form-5
Finished product Specification BP specifications
Approval status of product in Sodium Chloride 0.9% Intravenous Infusion by M/s Eastgate
Reference Regulatory Authorities. Way (MHRA)
Me-too status Lifesol IV Infusion by M/s Geofman
GMP status Last GMP Inspection dated 12-6-17 with conclusive remarks of
good cGMP compliance.
Previous decision(s) Deferred for clarification of composition as firm has mentioned
Normal saline instead of Sodium chloride in Form 5 and master
formulation. Details of container closure system (glass or
plastic) are required (M-275).
Evaluation by PEC ● The firm has submitted that
● ―Due to some typographical error the composition of the
product was mentioned as Normal saline 0.9% instead of
sodium chloride 0.9%.‖
● Now the firm has submitted revised Form-5 with following
label claim:
● Each vial contains:
Sodium chloride………………0.9%
● 100ml vial (Infusion packed in plastic bottles)
● The firm has deposited fee challan Rs. 20,000/- (Deposit
slip#0610570) dated 28-11-2018. (photocopy attached)
Decision: Registration Board approved the formulation with following revision:
Each vial contains:
Sodium chloride………………0.9%

1788. Name and address of manufacturer / M/s Pharmix Laboratories, 21km Ferozpur Road, Lahore.
Applicant
Brand Name +Dosage Form + Strength SUNDROP Oral Drops
Cholecalciferol…..……….5mg
Diary No. Date of R& I & fee Dy. No.625, R&I Dated 11.12.2014, Rs. 20,000/-
Type of Form Form-5
Finished product Specification Manufacturer‘s Specs
Pack size & Demanded Price 1x10ml,1x30ml &Rs.700/pack of 10ml,Rs.2000/pack of 30ml
Approval status of product in Finnish Medicine Agency
Me-too status Doplet Oral Drops of M/s Saffron Pharma (Reg#078963)
GMP status GMP inspection conducted on 31-05-2018 to 01-06-2018
concluded that the firm has improved the documentation
regarding production, QC and QA and the firm has installed a
new HPLC (gradient system) and double beam UV
spectrophotometer.
Previous remarks of the Evaluator. The composition of the proposed drug is incorrectly mentioned
in Form-5 as ―each 10 ml contains cholecalciferol 5mg/10ml‖
is written. Moreover, brand name resembles the other firms‘
drug.
Previous decision(s) Deferred for evidence of approval in reference agencies and
me-too status. Moreover, the proposed composition of the drug
needs to be verified since both strengths 5mg/10ml and 5mg/ml
are mentioned in the dossier.
(M-271).
Deferred for confirmation of approval status of applied
formulation in reference regulatory authorities/agencies and
their generic / me-too status (M-275).
Evaluation by PEC  Firm has clarified the proposed strength as 5mg/10ml (eq. to
20,000 IU/ml or 0.5mg cholecalciferol / ml).
 The submitted me-too reference ―Doplet-Oral Drops of M/s.
Saffron Pharma‖ has been verified.
 The approval status of applied formulation has been
confirmed in Finnish medicine agency.
 The firm has submitted fee challan of Rs. 5,000/- (deposit slip
# 0811091) dated 25-04-2019.
1789. Name and address of manufacturer / M/s. Hamaz Pharmaceuticals (Pvt.) Ltd, 13-Km, Bosan Road,
Applicant Lutfabad Multan
Brand Name +Dosage Form + Strength ZEETOP 20mg Tablets
Composition Each dispersible tablet Contains:-
Zinc Sulphate Monohyrate USP eq. to ….20mg elemental
Zinc.
Diary No. Date of R& I & fee 351, 03.03.2015, Rs.8000/-, Rs.12000/-, 02-03-2015
Pharmacological Group Indirectly-acting sympathomimetic
Type of Form Form-5
Finished product Specification International pharmacopoea
Pack size & Demanded Price 1*10‘s; As per brand leader
Approval status of product in WHO approved formulation
Me-too status Zindigi by Zafa Pharmaceuticals
GMP status GMP inspection dated 17-01-2018 concluded as follows:
In view of all the above it is observed that the management has
addressed most of the short comings, which were pointed out
during the last inspection which leads the panel of inspectors to
the conclusions that the firm is presently operating at
satisfactory level of GMP compliance. M/s Hamaz
Pharmaceuticals is situated at Multan hence it is advised to the
management to continue their efforts to further upgrade their
systems.
Previous decision(s) Deferred for confirmation of dosage form whether dispersible
tablet or otherwise. (M-266)
Evaluation by PEC The firm has submitted revised master formulation for
dispersible tablet. However, fee for such revision not
submitted.
Decision: Deferred for submission of fee for revision of formulation.
1790. Name and address of manufacturer / M/s Noa Hemis Pharmaceuticals, Plot # 154, Sector 23,
Brand Name +Dosage Form + Strength Flexibon Delayed Release Tablet
Composition Each delayed release tablet contains
Diclofenac Sodium (enteric coated)………..50mg
Misoprostol (1% w/w dispersion HPMC)………200mcg
Diary No. Date of R& I & fee Dy. No. 168 dated 17-09-2011 & 10-04-2014Rs. 20,000/-
Pharmacological Group NSAID/ Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 20‗s Rs. 350/-
Approval status of product in Arthrotec 50 modified release tablets of Pfizer (MHRA
Reference Regulatory Authorities. approved)
Me-too status Cytopan 50mg tablet of M/s GETZ Pharma (Reg#039729)
GMP status GMP inspection dated 20-03-2018 is considered to be
operating at an acceptable level of compliance.
Previous decision(s) Deferred for completion of application w.r.t following
Shortcomings (M-256):-
To furnish approval status of same dosage form in reference
To submit complete dosage form alongwith quantities of salt
and base in master formulation per unit dose and per batch.
To furnish master formulation with amount of base as well as
salt per unit dose and per batch.
Official monographs/reference pharmacopeia required for
active and inactive ingredient in the master formulation.
Reference of finished product specification alongwith
procedure of analysis.
Deferred for the clarification of manufacturing outline as in
reference regulatory authorities (M-283).
Evaluation by PEC The firm has submitted complete master formulation stating
enteric coated Diclofenac sodium and Misoprostol (1%
dispersion w/w in HPMC).
The firm has submitted fee challan of Rs. 5,000/- (Deposit
slip#0308598) dated 13-02-2019.
However, the firm has not clarified the manufacturing outline.
Decision: Deferred for clarification of manufacturing outline for applied formulation.
1791. Name and address of manufacturer / M/s. Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km, Feroz Pur
Brand Name +Dosage Form + Strength Fuzo SR Tablet 10mg
Alfuzosin HCl………….10mg
Diary No. Date of R& I & fee Dairy No. 5564 dated 5.06.2013, Rs:20,000/-
Pharmacological Group Selective alpha 1- adrenergic blocker
Type of Form Form-5
Pack size & Demanded Price Rs. 980/ 30‘s
Approval status of product in Uroxatral extended release tablets, USFDA
Me-too status Luzio SR Tablet 10mg by Wilshire Laboratories,
GMP status Panel inspection dated 30-08-2017 recommended for renewal
of DML.
 Availability in SRA is not provided by the firm.
 Reference literature for detailed specification and analytical
method is required.
 Latest Inspection Report is required.
conduct GMP inspection of Firm on priority. (M-285).
Deferred for revision of formulation and label claim as per the
reference regulatory authorty approved reference product (M-
288).
Evaluation by PEC The firm has submitted following:
Commitments as per 251st meeting of RB are required.
The formulation is approved in MHRA.
The firm has submitted in-house specs and detail of analytical
method.
The firm has submitted revised master formulation with correct
label claim as below:
Each extended release tablet contains:-
Alfuzosin Hydrochloride………….10mg
Fee challan of Rs. 5,000/- (Deposit slip # 1916772) dated 06-
05-2019 has been submitted.
Decision: Registration Board approved with innovator‘s specifications and with following revision:
Each extended release tablet contains:-
Alfuzosin Hydrochloride………….10mg
1792. Name and address of manufacturer / M/s. Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km, Feroz Pur
Brand Name +Dosage Form + Strength Feriwin-F Tablet
Iron Protein Succinylate….……..20mg
Folic acid……………………2.5mg
Diary No. Date of R& I & fee Dairy No. 5567 dated 5.06.2013, Rs:20,000/-
Pharmacological Group Heamatinic Drug
Type of Form Form 5
Me-too status Sucrofer-F Tablets of CCL pharma (Reg#052640)
GMP status The firm was last inspected on 07.06.2017 & 30.08.2017,
wherein the panel recommended the renewal of DML
 Availability in SRA is not provided by the firm.
 Reference literature for detailed specification and analytical
method is required.

 Latest Inspection Report is required.
conduct GMP inspection of Firm on priority. (M-285)
Deferred for submission of fee for revision of formulation (M-
288).
Evaluation by PEC The firm has submitted following:
Commitments as per 251st meeting of RB are required.
The firm has submitted revised Form-5 stating label claim as
below:
Iron Protein Succinylate eq. to elemental Iron…..20mg
Folic acid…………………….…2.5mg
The firm has submitted in-house specs and detail of analytical
method.
The firm has submitted fee challan of Rs. 20,000/- (Deposit
slip# 1916775) dated 06-05-2019.
1793. Name and address of manufacturer / M/s Inventor Pharma,
Applicant Plot No. K/196, S.I.T.E, (SHW) Phase-II, Karachi
Brand Name +Dosage Form + Strength In-ORS Solution 500ml
Sodium Chloride ……………………1.75gm
Trisodium Citrate Trihydrate ……..1.45gm
Potassium Chloride ……………..0.75gm
Glucose Anhydrous ……………..10gm
Diary No. Date of R& I & fee Diary No: 13910, 30/08/2017, Rs: 20,000/-
Type of Form Form 5
Pack size & Demanded Price 1‘sx500ml; As per SRO
Approval status of product in Standard ORS formulation
Me-too status Pedinex Oral Rehydration Solution by M/s Nexus Pharma (Pvt)
Ltd (Reg#057883)
New License
Previous decision(s) Deferred for confirmation whether applied formulation is
preservative free or not. (M-277)
Deferred for confirmation of terminal sterilization method for
applied formulation. (M-286)
Evaluation by PEC  The firm has submitted that we have removed ―Sodium
benzoate‖ from our formulation and our new formulation for
this product is free from preservative.
 The firm has submitted fee challan of Rs.5000/-, (Deposit
slip#0808315) dated 05-11-2018 for revision of formulation.
 The liquid is filled under the area of laminar flow hood in
polypropylene bottle immediately sealed.
 Bottle are sterilized in autoclave with steam upto 100oC for
3 hours and pressure 1 to 2 bars.
 GMP inspection conducted on 06th February, 2019
concluded that keeping in view the stated conditions and
attitude of the firm towards better compliance, their current
GMP is rated as GOOD.
Decision: Deferred for confirmation of capacity of autoclave for terminal sterilization.

Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
M/s. Athan Pharmaceuticals Plot No 84/1, block B, Phase V industrial Estate, Hattar
CLB in its 269th meeting held on 26th February, 2019 has considered and approved the grant of
DML # 000900 by way of formulation with following sections:
Tablet General Section: (10molecules/21products)

Cream/Ointment (General) section: (8molecules/ 8products)
Liquid ampoule (General) section: (10molecules/ 10products)
Dry Powder vial (General) section: (6molecules/ 8products)
Oral Powder Suspension (General) section (4molecules/ 4products)
Sachet (General) Section: (1molecule/ 1product)
Ophthalmic (General) Drop Section
Capsule section (General)
Tablet General section (10molecules/ 21products)
1794. Name and address of manufacturer / M/s. Athan Pharmaceuticals Plot No 84/1, block B, Phase V
Applicant industrial Estate, Hattar
Brand Name +Dosage Form + Strength Athapine 10/160mg Tablet
Composition Each film coated Tablet contains:-
Amlodipine as besylate.…..10mg
Valsartan..................160mg
Pharmacological Group Calcium channel blocker+ Angiotensin receptor blockers
Type of Form Form-5
Approval status of product in Reference Exforge Tablet ( USFDA Approved)
Me-too status Co-Valzaar 10mg/160mg Tablet by M/s Vision Pharma
GMP status CLB in its 269th meeting held on 26th February, 2019 has
considered and approved the grant of DML (#000900) by way
of formulation with following section:
Tablet General section
Decision: Approved.
Brand Name +Dosage Form + Strength Athapine 5mg/160mg Tablet
Amlodipine as besylate…….…5mg
Valsartan...........................160mg
Type of Form Form-5
Approval status of product in Reference Amlodipine/Valsartan 5mg/160 mg tablet (MHRA Approved)
Me-too status Exforge Tablet of M/s Novartis Pharma (Reg # 047570)
Decision: Approved.

Amlodipine as besylate ……10mg
Valsartan...................80mg
Type of Form Form-5
Approval status of product in Reference Not confirmed
Evidence of approval of applied formulation in reference regulatory authorities/agencies adopted
by the Registration Board in 275th meeting.
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
Valsartan..............................80mg
Type of Form Form-5
Approval status of product in Reference Exforge Tablet By Novartis USFDA Approved
Me-too status Exforge tablet by M/s Novartis
Decision: Approved.
Brand Name +Dosage Form + Strength Atro 10/40mg Tablet
Ezetimibe………...10 mg
Atorvastatin………..40 mg
Pharmacological Group HMG-CoA reductase inhibitor and other lipid modifying
agents
Type of Form Form-5
Approval status of product in Reference USFDA Approved.
Me-too status Atozet 10/40 tablet of M/s Hilton Pharma
Remarks of the Evaluator. Salt form of atorvastatin is not mentioned. Revision of Form-
5 with requisite fee is required.

You have claimed BP and innovator‘s specifications
simultaneously for your finished product. Clarification is
required.
 Revision of formulation as per reference product along with submission of requisite fee.
 Clarification of finished product specifications of applied formulation.
Brand Name +Dosage Form + Strength Atro 10/20mg Tablet
Ezetimibe….............10mg
Atorvastatin…..........20mg
Pharmacological Group Lipid lowering Agent
Type of Form Form-5
Me-too status Atozet 10/20 tablet of M/s Hilton Pharma (Reg#061223)
Remarks of the Evaluator. Salt form of atorvastatin is not mentioned. Revision of Form-
5 with requisite fee is required.
You have claimed BP and innovator‘s specifications
simultaneously for your finished product. Clarification is
required.
 Revision of formulation as per reference product along with submission of requisite fee.
 Clarification of finished product specifications of applied formulation.
Brand Name +Dosage Form + Strength Aultostat 40mgTablets
Febuxostat…………….....40 mg
Pharmacological Group Anti-gout preparations (preparations inhibiting uric acid
production)
Type of Form Form-5
Me-too status ZURIG 40mg TABLETS GETZ PHARMA
Decision: Approved.
Brand Name +Dosage Form + Strength Aultostat 80mgTablets
Febuxostat….................80 mg
Pharmacological Group Anti-gout preparations (preparations inhibiting uric acid
production)
Type of Form Form-5

Me-too status Febuxin by M/s AGP, Karachi (Reg. No. 081105)
Decision: Approved.
Brand Name +Dosage Form + Strength Lokosa 100mg Tablet
Lacosamide.………....…100mg
Pharmacological Group Antiepileptics, other antiepileptics, ATC code N03AX18
Type of Form Form-5
Approval status of product in Reference Lacosamide Aspire 100 mg film-coated tablets by M/s Aspire
Regulatory Authorities. Pharma Limited (MHRA Approved)
Me-too status Lalap 100mg Tablet by M/s Genix Pharma (Pvt.) Ltd
(Reg#070471)
Brand Name +Dosage Form + Strength Losa 50mg Tablet
Lacosamide.……..…50mg
Pharmacological Group Antiepileptics, other antiepileptics, ATC code: N03AX18
Type of Form Form-5
Me-too status Lacolep 50mg by Hilton Pharma
Brand Name +Dosage Form + Strength Adyzil 400mg Tablet
Linezolid.……..…………..400mg
Pharmacological Group Oxazolidinone antibiotic
Type of Form Form-5
Approval status of product in Reference Zyvox 400 mg film-coated tablets by Pharmacia Limited
Regulatory Authorities. (USFDA Approved and discontinued but for reasons other
than safety and efficacy as per USFDA website)
Me-too status Linzor 400mg Tablets by Hilton Pharma
Remarks of the Evaluator. Master formulation does not contain ingredients for film
coating. Correction is required.
Decision: Deferred for revision of master formulation as per reference formulation alongwith
requisite fee.
Brand Name +Dosage Form + Strength Adyzil 600mg Tablet
Linezolid.…………...…600mg
Type of Form Form-5
Approval status of product in Reference Zyvox 600 mg film-coated tablets by M/s Pharmacia Limited,
Regulatory Authorities. MHRA approved.
Me-too status Ecasil 600mg tablet by M/s Sami (Reg#066904)
Decision: Approved.
Brand Name +Dosage Form + Strength Aultaxe 4mg Tablets
Lornoxicam……………....4mg
Type of Form Form-5
Approval status of product in Reference Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG,
Regulatory Authorities. (Swiss Medic approved)
Me-too status Acabel 4mg Tablet by M/s Continental Pharma (R#061603)
Remarks of the Evaluator. The product name mentioned on fee challan is
Thiocolchicoside 4mg while product name mentioned on
Form-5 is Aultaxe 4mg Tablet.
Decision: Approved.
Brand Name +Dosage Form + Strength Aultaxe 8mg Tablets
Lornoxicam……………....8mg
Type of Form Form-5
Approval status of product in Reference NOXON 8 mg film-coated tablets. (AIFA approved)
Me-too status Lornoxi DS 8mg Tablet. Reg. No. 74933
Decision: Approved.
Brand Name +Dosage Form + Strength Rispron 1mg Tablets
Risperidone…………..…1mg
Type of Form Form-5
Me-too status Tablet Resjun -1 of M/s Jupiter Pharma Islamabad. (Reg.#
081921)
Decision: Approved.
Type of Form Form-5
Me-too status Riss 2mg tablet of M/s Shawan Pharma (Reg. # 080378)
Decision: Approved.
Type of Form Form-5
Me-too status Riss 4mg tablet of M/s Shawan Pharma (Reg. # 080376)
Decision: Approved.
Brand Name +Dosage Form + Strength CITA 50/500mg Tablets
Composition Each film coated Tablet contains:
Sitagliptin……………….50 mg
Metformin………………500 mg
Type of Form Form-5
Finished product Specification specifications
Approval status of product in Reference JANUMET™ (sitagliptin/metformin HCl) tablets
Me-too status S-Gliptin Plus Tablets of M/s Barrett Hodgson
Remarks of the Evaluator. Salt forms of sitagliptin and metformin are not mentioned.
Revision of Form-5 with requisite fee is required.
Brand name mentioned in master formulation is CITAWEL
which is different from that mentioned in Form-5.
Product name mentioned in finished product specification part
is CITAWEL Tablet. Clarification is required.
 Revision of formulation as per reference product alongwith requisite fee.
 Clarification of brand name of applied formulation.
Brand Name +Dosage Form + Strength CITA 50/1000mg Tablet
Composition Each film coated Tablet contains:
Sitagliptin……………….50 mg
Metformin………………1000 mg
Type of Form Form-5
Approval status of product in Reference ARTG ID: 149023; JANUMET 50mg/1000mg film-coated
Regulatory Authorities. tablet by M/s Merck Sharp & Dohme (Australia) Pty Ltd
(Approved in TGA).
Me-too status Neoglip 50/1000mg Tablets of M/s Atco Laboratories Ltd
(Reg#053100)
Remarks of the Evaluator. Salt forms of sitagliptin and metformin are not mentioned.
Revision of Form-5 with requisite fee is required.
Brand name mentioned in master formulation is CITAWEL
which is different from that mentioned in Form-5.
Brand name mentioned in specification part is CITAWEL.
 Clarification of brand name of applied formulation.
Brand Name +Dosage Form + Strength Aultolax 4 mg Tablets
Thiocolchicoside……..…....4 mg
Pharmacological Group Innovator specification
Type of Form Form-5
Approval status of product in Reference Approved in ANSM (France) as uncoated tablet
Me-too status Wodnik 4mg tablet of M/s Martin Dow (Reg. # 081138)

Remarks of the Evaluator. Approved in ANSM (France) as uncoated tablet while it is
applied as film-coated.
Fee challan mentions capsule dosage form while submitted
Form-5 suggests tablet dosage form.
 Clarification of dosage form in Form-5.
Brand Name +Dosage Form + Strength M-Cobo 500 mcg/ Tablet
Mecobalamin ……………….500 mcg
Type of Form Form-5
Finished product Specification JP specifications
Pack size & Demanded Price 2 × 10‘s; As fixed by Govt.
Approval status of product in Reference Approved by PMDA of Japan
Me-too status Mecomed 500mcg by Global Pharma (Reg. No. 041670)
Remarks of the Evaluator. In contrary to reference product approved by PMDA of Japan,
which is available as sugar coated tablet, firm has applied for
film coated tablet.
Decision: Deferred for revision of formulation as per reference product alongwith requisite fee.
Cream/Ointment (General) section (8molecules/ 8products)
Brand Name +Dosage Form + Strength Dermo 0.05% Cream
Composition Each tube contains:
Clobetasol propionate……………..0.05%
Type of Form Form-5
Finished product Specification In-house specification
Pack size & Demanded Price 15g & 30g; As fixed by Govt
Approval status of product in Reference ClobaDerm 500 micrograms/g Cream by Auden Mckenzie
Regulatory Authorities. (Pharma Division) Ltd. (MHRA approved)
Me-too status Clobicare Cream by Martin Dow Pharmaceuticals (Reg#
067938)
Brand Name +Dosage Form + Strength Omegga Cream 0.1%
Momeggasone……………..0.1%
Type of Form Form-5
Pack size & Demanded Price 5g & 15g; As fixed by Govt
Approval status of product in Reference Not confirmed
Me-too status Momeggaderm Cream of Neophar Pharma
(Not confirmed)
adopted by the Registration Board in 275th meeting.
Brand Name +Dosage Form + Strength Mycin Vaginal Cream 2.0%
Clindamycin as phosphate…………..2.0%
Type of Form Form-5
Finished product Specification USP specification
Approval status of product in Reference Cleocin (USFDA approved)
Me-too status Clindanor 2% cream of M/s Nortech pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Fusihyd Cream 15g
Composition Each gram cream contains:
Fusidic Acid ………………..20mg (2%)
Hydrocortisone…………….10mg (1%)
Type of Form Form-5
Approval status of product in Reference Fucidin H Cream (UK MHRA Approved)
Me-too status Melas H Cream of M/s Atco Laboratories
Remarks of the Evaluator. Salt form of Hydrocortisone is not mentioned in Form-5.
Revision of Form-5 with applicable fee is required.
Brand Name +Dosage Form + Strength Terbilet Cream 1.0%
Terbinafine………………1.0%
Type of Form Form-5
Pack size & Demanded Price 5g & 10g; As per SRO
Me-too status Bina 1.0% Cream by M/s Linta pharmaceuticals (Pvt) Limited
, Islamabad (Reg.# 080268)
Remarks of the Evaluator. Salt form of Terbinafine is not mentioned in Form-5.
Revision of Form-5 with applicable fee is required.
Brand Name +Dosage Form + Strength Salic Acid Ointment
Salicyclic acid ………………..2.0 % w/w
Pharmacological Group Salicylate
Type of Form Form-5
Finished product Specification BP specification
Approval status of product in Reference Salicylic acid Ointment 2.0% of Thornton and Ross (MHRA
Regulatory Authorities. approved)
Me-too status Movelat ointment of ATCO (Not confirmed)
Remarks of the Evaluator. Evidence of applied formulation already approved
(generic/me-too) by DRAP /DCO is required.
Brand Name +Dosage Form + Strength Dyclin Gel 50gm
Diclofenac Diethylamine…………….1.16%
Type of Form Form-5
Finished product Specification BP specification
Approval status of product in Reference Approved in MHRA (Voltarol 1.16% Emulgel) 10grams /
Regulatory Authorities. 20grams)
Me-too status Voltral emulgel of M/s GSK (Pvt.) Ltd. (Reg.# 083991)
Remarks of the Evaluator. Label claim of applied formulation is not as per reference
product. Revision of Form-5 with applicable fee is required.
Revision of formulation as per reference formulation alongwith requisite fee.
Clarification regarding required manufacturing facility since section is of cream/ointment while
applied formulation is gel.
Brand Name +Dosage Form + Strength Permet 5% Lotion
Permethrin………………50mg
Pharmacological Group Scabicide
Type of Form Form-5
Finished product Specification Innovator‘s specification
Approval status of product in Reference Permethrin Lotion 5% w/w by M/s GlaxoSmithKline
Regulatory Authorities. Consumer Healthcare (UK) Trading Limited (MHRA
Approved)
Me-too status Nedax Plus Lotion of M/s Stiefel (Reg#037852)

Remarks of the Evaluator. The applied formulation does not specify whether the
formulation is w/w or w/v.
Decision: Deferred for clarification regarding required manufacturing facility since section is of
cream/ointment while applied formulation is lotion.
Liquid ampoule (General) section (10molecules/ 10products)
Brand Name +Dosage Form + Strength ARO Injection 5ml
Composition Each 5ml amber glass ampoule contain:
Iron Sucrose eq. to elemental iron……………..100mg
Pharmacological Group Antianeamic
Type of Form Form-5
Pack size & Demanded Price 5ml × 5‘s; As fixed by Govt
Approval status of product in Reference Venofer Injection by Vifor
Me-too status Vortex 100mg/ 5ml injection of Saturn Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Aultaxe 8mg/2ml Injection
Composition Each injection contains:
Lornoxicam (lyophilized) …………….8mg
Type of Form Form-5
Pack size & Demanded Price 1‘s vial; As recommended by PRC
Approval status of product in Reference Xefo 8 mg powder and solvent for solution for injection by
Regulatory Authorities. M/s Takeda Austria GmbH, (Austria Approved)
Me-too status Zafon 8mg injection of M/s Getz
Decision: Rejected as firm doesnot have manufacturing facility.
Brand Name +Dosage Form + Strength Atrawel 50mg / 5ml Injection
Composition Each ampoule contains:
Atracurium Besylate………………..50mg
Type of Form Form-5
Pack size & Demanded Price 5ml × 5‘s; As per SRO
Me-too status Atrium Injections by M/s Searle Pakistan, Karachi
(Reg#053342)
Decision: Approved.

Brand Name +Dosage Form + Strength CITIL Injection
Citicoline sodium………………250mg (250mg/2ml)
Pharmacological Group Psychostimulants and nootropics
Type of Form Form-5
Pack size & Demanded Price 2ml ; As per SRO
Approval status of product in Reference CITICOLINE PANPHARMA 250 mg / 2 ml solution for
Regulatory Authorities. injection (IM, IV) ampoule by M/s PANPHARMA (ANSM,
France Approved)
Me-too status Cerebolin Injection 250mg/2ml by M/s Zam Zam
(Reg#021969)
Remarks of the Evaluator. 3% Overage is mentioned in master formulation.
Decision: Registration Board deferred the case for justification of 3% overage in master
formulation.
Brand Name +Dosage Form + Strength Irofer 500mg /10ml injection
Composition Each ampoule of 10ml contains:
Iron as ferric carboxymaltose……….500mg
Type of Form Form-5
Pack size & Demanded Price 10ml × 1‘s; As fixed by Govt.
Me-too status Ferinject Injectable 10ml vial of M/s M/s. RG Pharmaceutica
(Pvt.) Ltd., (Reg.# 072548)
formulation.
Brand Name +Dosage Form + Strength Athonate 50mg/5ml Injection
Calcium folinate………….50mg
Pharmacological Group Detoxyfying agent for antineoplastic treatment
ATC code: V03AF03
Type of Form Form-5
Approval status of product in Reference Leucovorin Calcium Of (TGA Approved)
Me-too status Kunyrin 50mg/5ml Injection By Al-Habib (Reg. No. 021041)
Decision: Approved.

Brand Name +Dosage Form + Strength Acobal 1ml injection
Composition Each 1ml injection contains:
Mecobalamin………….500mcg
Type of Form Form-5
Pack size & Demanded Price 1ml; As fixed by Govt
Approval status of product in Reference PMDA approved
Me-too status Wycomin 500 mcg Injection by Wnsfeild Pharmaceutical
Remarks of the Evaluator. R & I date mentioned is 07-09-2019 and date mentioned on
fee challan is 07-06-2019.
Brand name mentioned on fee challan is Acobalamin while
that mentioned on Form-5 is Acobal 1ml Injection.
Pharmacological group is not written on Form-5.
3% Overage is mentioned in master formulation.
Decision: Deferred for clarification of brand name on fee challan and justification of 3% overage
in master formulation.
Brand Name +Dosage Form + Strength Kitax Injection 1ml
Ketorolac Tromethamine…………….30mg / ml
Type of Form Form-5
Approval status of product in Reference Toradol Injection of Atnahs Pharma, UK (MHRA
Me-too status Toralac Injection 30mg/ml by M/s Vision Pharma(R#050290)
formulation.
Brand Name +Dosage Form + Strength AT-D Injection 1ml
Cholecalciferol……………..5mg
Type of Form Form-5
Pack size & Demanded Price 1ml × 1‘s; As fixed by Govt
Approval status of product in Reference Vitamin D3 BON of Bouchara, ANSM Approved
Me-too status GET-D of GETZ Pharma Pakistan
formulation.

Brand Name +Dosage Form + Strength Ondansetron Injection 8mg/4ml
Ondansetron as hydrochloride dihydrate………8mg
Type of Form Form-5
Pack size & Demanded Price 4ml ×5‘s ; As per SRO
Approval status of product in Reference Ondansetron 8mg/4ml solution for injection
Regulatory Authorities. (MHRA approved)
Me-too status Zofran 8mg/4ml injection of M/s GSK
formulation.
Dry Powder vial (General) section: (6molecules/ 8products)
Brand Name +Dosage Form + Strength D-Cript 120mg injection
Artesunate…………………120mg
Type of Form Form-5
Finished product Specification IP specification
Pack size & Demanded Price 1‘s vial; As fixed by Govt
Approval status of product in Reference WHO prequalified formulation
Me-too status Gen-M Injection 120mg of M/s Genix (Reg. # 076073)
Dry Powder vial (General) section
Decision: Approved.
Brand Name +Dosage Form + Strength E-Cript 60mg Injection
Artesunate………………..60mg
Type of Form Form-5
Finished product Specification IP specifications
Approval status of product in Reference WHO Prequalified formulation
Me-too status Gen-M Injection 60mg of M/s Genix (Reg # 047630)
Decision: Approved.
Brand Name +Dosage Form + Strength Vanco 500mg Injection

Vancomycin hydrochloride…………..500mg
Type of Form Form-5
Approval status of product in Reference Vancomycin 500mg Powder for Concentrate for Solution for
Regulatory Authorities. Infusion by M/s Actavis UK Ltd, MHRA approved.
Me-too status Vancomycin 500mg Vial by M/s Abbott (Reg#015015)
Remarks of the Evaluator. Brand name mentioned on fee challan is different from that
mentioned in Form-5. Correction is required.
Decision: Approved.
Brand Name +Dosage Form + Strength Vanco 1gm Injection
Vancomycin hydrochloride………………1gm
Pharmacological Group Tricyclic glycopeptide antibiotic
Type of Form Form-5
Approval status of product in Reference Vancomycin, 1000 mg, Powder for concentrate for solution
Regulatory Authorities. for infusion of Hikma Pharam (MHRA approved)
Me-too status Vancotech Dry Powder Injection of Fynk Pharma (Reg #
081268)
Decision: Approved.
Brand Name +Dosage Form + Strength Colomat 1million IU /vial Injection
Colistimethate sodium eq. to Colistimethate (lyophilized
powder)……………..1MIU
Pharmacological Group Antibiotic (polymixin) ATC code: A07J01XB01
Type of Form Form-5
Me-too status Colistat Injection of M/s Medisure Lab (Reg#076160)
Remarks of the Evaluator. Label claim is not as per reference formulation which is
colistimethate sodium………..1MIU while you have applied
colistimethate ………1MIU.
Decision: Deferred for evidence of approval of manufacturing facility for Dry Powder Lyophilized
injectable section.
Brand Name +Dosage Form + Strength Purple Injection 40mg
Esomeprazole as sodium (lyophilized powder) ……40mg

Pharmacological Group Proton Pump inhibitor
Type of Form Form-5
Me-too status Nexum Injection 40mg of M/s Getz Pharma (Reg. # 050651)
Decision: Approved.
Brand Name +Dosage Form + Strength Peptun 40mg injection
Pantoprazole as sodium (Lyophilized powder)….….40mg
Pharmacological Group Proton Pump inhibitor
Type of Form Form-5
Approval status of product in Reference MHRA approved
Me-too status Pazole Dry Powder Injection IV 40mg of M/s Fynk
pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Dysozole 40mg Injection/ Infusion
Omeprazole as sodium (Lyophilized powder)……40mg
Type of Form Form-5
Me-too status Risek 40mg Infusion by Getz
Decision: Approved.
Oral Powder Suspension (General) section (4molecules/ 4products)
Brand Name +Dosage Form + Strength Linzal Dry Suspension 100mg/5ml
Composition Each 5ml suspension contain:
Linezolid…………….100mg
Type of Form Form-5
Pack size & Demanded Price 60ml; As fixed by Govt
Approval status of product in Reference Linezolid 100 mg/5 ml granules for oral suspension by
Regulatory Authorities. Pfizer.(PL 00057/1420) Approved in MHRA
Me-too status Nezolid 100mg Suspension of Searle Pak, Karachi
(Reg. # 050326)
Oral Powder suspension (General) section
Decision: Approved.
Brand Name +Dosage Form + Strength Aultazole 50mg / 5ml Suspension
Fluconazole……………..10mg
Type of Form Form-5
Pack size & Demanded Price 30ml; As recommended by PRC
Me-too status Zefung Dry Powder Suspension of Nexus Pharma
Remarks of the Evaluator. Fee challan does not specify brand name, strength and dosage
form of applied product. Only API is written as
―Fluconazole‖.
Label claim and master formulation does not suggest Dry
powder suspension. Revision of Form-5 is required.
Decision: Deferred for revision of formulation as per reference product alongwith submission of
applicable fee.
Brand Name +Dosage Form + Strength CLARTON 125mg /5ml Dry Suspension
Clarithromycin taste masked granules 27.5% eq. to
Clarithromycin……………..125mg / 5ml
Type of Form Form-5
Approval status of product in Reference Biaxin granules for oral suspension 125mg/5mlbyM/s
Regulatory Authorities. Abbvie, USFDA approved.
Me-too status Klarim Dry Suspension 125mg/5ml of Amrose Pharma
Remarks of the Evaluator. Brand name mentioned on Fee challan Clartex 125mg / 5ml
while that mentioned on Form-5 is Clarton 125mg / 5ml.
Source of granules is required to be submitted.
Decision: Deferred for clarification of brand name on fee challan and submission of source of
clarithromycin granules.
Brand Name +Dosage Form + Strength Azithromycin 250mg Dry Suspension
Azithromycin ……………..250mg

Type of Form Form-5
Approval status of product in Reference Zithromax 200mg/ 5ml powder for oral suspension of M/s
Regulatory Authorities. Pfizer Limited (MHRA Approved)
Me-too status Azomax 200mg oral suspension of M/s Novartis Pharma,
Pakistan (Reg. # 022201)
Remarks of the Evaluator. You have applied Azithromycin 250mg Dry Suspension while
reference formulation is 200mg Dry Suspension. Clarification
/ Revision of Form-5 with requisite fee is required.
Sachet (General) Section (1molecule/ 1product)
1845. Name and address of manufacturer / M/s. Athan Pharmaceuticals Plot No 84/1, block B, Phase
Applicant V industrial Estate, Hattar
Brand Name +Dosage Form + Strength Athanpartate 3gm Oral Granules
Composition Each 5g Oral Granules contains:
L-ornithine Aspartate………………3gm
Pharmacological Group Hepatoprotective, Lipotropic
Type of Form Form-5
Pack size & Demanded Price 5g Sachet × 5‘s; As per SRO
Approval status of product in Reference Approved in Austria
Me-too status Hepaser Sachet 3gm of M/s Panacea Pharma (Reg#075403)
Case No. 03: Registration applications of newly granted DML or New section (Veterinary)
a. New section
Liquid Injectable (Hormone) Section: (5molecules/12 products)
1846. Name and address of manufacturer / M/s Mylab PVT. LTD., Khankah Shariff, Bahawalpur
Applicant
Brand Name +Dosage Form + Strength BUSALIN INJECTION
Buserelin Acetate……0.0042mg eq. to 0.004mg of Buserelin
Pharmacological Group Gonadotropin-releasing hormone agonist
Type of Form Form 5
Pack size & Demanded Price 10ml × 10‘s clear glass vial; Decontrolled
Me-too status Conceptal Injection of M/s STAR LAB (Reg#058939)
GMP status CLB in its 266th meeting held on 24th October, 2018 has
considered and approved the following additional section.
Liquid Injectable (Hormone) Section (DML# 000747).
Remarks of the Evaluator. Follix Injection is mentioned on fee challan. Clarification is
required.
Clarification regarding manufacturing facility whether steroidal or non-steroidal hormone
section.
Clarification of applied product on fee challan.
Applicant
Buserelin Acetate……………0.0042mg eq. to 0.004mg of
Buserelin
Type of Form Form 5
Me-too status Conceptal injection of M/s STAR LAB (Reg#058939)
Applicant
Buserelin Acetate…0.0042mg eq. to 0.004mg of Buserelin
Type of Form Form 5
Pack size & Demanded Price 2.5ml × 10‘s clear glass vial; Decontrolled
Me-too status Conceptal injection of M/s STAR LAB (Reg#058939)
Applicant
Brand Name +Dosage Form + Strength FOLLIX INJECTION
Estradiol dipropionate……………..1.00mg
Pharmacological Group Synthetic Estrogen
Type of Form Form 5
Pack size & Demanded Price 10ml clear glass vial; Decontrolled
Me-too status Agofollin injection of Ghazi Brothers (Reg#028587)
Applicant
Brand Name +Dosage Form + Strength FOLLIX INJECTION

Estradiol dipropionate……………..1.00mg
Type of Form Form 5
Me-too status Agofollin injection of Ghazi Brothers (Reg#028587)
Applicant
Brand Name +Dosage Form + Strength DROSTEN INJECTION
D-Cloprostenol……………..0.75mg
Pharmacological Group Synthetic Prostaglandin analogue
Type of Form Form 5
Me-too status Delmazine Injectable solution of M/s Prix Pharmaceutica
(Reg#018842)
Remarks of the Evaluator. The submitted me-too reference is of different strength i.e.,D-
Cloprostenol………….0.075 mg per ml.
Applicant
Type of Form Form 5
Me-too status Delmazine Injectable solution of Prix Pharma (R#018842)
Applicant

Type of Form Form 5
Me-too status Delmazine Injectable solution of M/s Prix Pharmaceutica
(Reg#018842)
Applicant
Brand Name +Dosage Form + Strength MYRALIN INJECTION
Lecirelin……………25mcg
Pharmacological Group Synthetic superanalogue of GnRH (gonadotropin releasing
hormone)
Type of Form Form 5
Me-too status SERILIN Injection of M/s Selmore Pharma (Reg#071092)
Applicant
hormone)
Type of Form Form 5
Applicant

hormone)
Type of Form Form 5
Applicant
Brand Name +Dosage Form + Strength STYROL INJECTION
Stilbestrol Dipropionate……………10mg
Type of Form Form 5
Me-too status BESTEROL Injection of M/s Selmore (Reg#071085)

a. Deferred cases
i. Human
1858. Name and address of Applicant M/s. Mehran Dental, Karachi. M No. Al Noor Centre Randle
Road, ADJANKLE Seria Hospital, Karachi
Details of Drug Sale License
Name and address of manufacturer M/s. Laboratorios zeyco s.a. De c.v. Camino a santa ana
tepetitlan no. 2230 colonia santa ana tepetitlan 45230 zapopan
jalisco, Mexico.
Name and address of marketing -do-
Name of exporting country Mexico
Diary No. & Date of R& I Diary No.153 Dated 17-02-2009
Fee including differential fee Rs.15000/- (18-06-2013) + Rs.85000/-
Brand Name +Dosage Form + Strength FD Injection IV
Composition Each 1.8ml ampoule contains: -
Lidocaine HCl………36.0mg
Epinephrine………….0.018mg
Pharmacological Group Local Anesthetic/Adrenergic agonist
Shelf life ---------
Pack size 1 x 10 cartridge ineach blister Total 5 blisterin packet Total 50
pieces of cartridges in Packet
Demanded price Rs. 1200/-
International availability Lidocaine and Epinephrine By Hospira, USFDA
Me-too status Rapicaine by S.Ejazuddin (imported)
Detail of certificates attached
Previous Remarks of the Evaluator. Sole agency agreement has been expired.
Pharmaceutical Product with English translation.
zone
IV-A conditions are ICH/WHO guidelines.
have not been provided along with data.
specifications while given assay method is not as same as

given in USP 35.
has not provided active raw material specifications.
material (glass vial).
Previous Decisions Registration Board deferred the case for rectification of

following observations in the dossier: (M-246)
a. Sole agency agreement has been expired.
b. GMP certificate of manufacturer has been expired.
c. Firm has not provided original & legalized Certificate of
Pharmaceutical Product with English translation.
d. Firm has not provided long term stability studies under zone
IV- A conditions are ICH/WHO guidelines.
e. Chromatograms in analytical methods & stability studies
have not been provided along with data.
f. Firm gave reference of USP for finished product
specifications while given assay method is not as same as
given in USP 35.
g. Firm has not provided active raw material specifications.
h. Firm has not provided specifications of primary packaging
material (glass vial).
g. Undertaking on desired format has not been submitted.
Registration Board deferred the case for the following
reasons (M-270)
 Only long term stability studies have been submitted while the
assay of all 3 batches of epinephrine shows a significant change
that is difference in the assay values is more than 5% from its
initial value.
 Following documents are not submitted:
Sole agency agreement
Original legalized CoPP
GMP certificate
Undertaking as per requirement of Form-5(A).
Evaluation by PEC 1. The product is available in USP as injection but the firm has
claimed In-House specifications.
2. Specifications for primary packaging material have been
provided.
 The firm has submitted justification for significant change in assay
values of epinephrine as follows:
―This requirement is mostly impossible to meet for any dental
cartridge manufacturer in the world given the physicochemical
properties of epinephrine. Our product FD is manufactured
with a 15% overage of epinephrine in order to counter
epinephrine fast degradation occurring from the solution
preparation until the manufacturing process is completed. The
USP monograph specifies that the solution should contain the
equivalent of not less than 90.0% and not more than 115.0% of
the labeled amount of Epinephrine. The unusual limits are due
to high degradation losses of epinephrine occurring during the
manufacturing process prior to the FPP release. Once the
solution is packed inside the cartridges, the degradation
becomes slower as the epinephrine stabilizes inside its
container. The purpose of the overage is not to extend the shelf
life of the product; instead, it is a part of the manufacturing
process in order to obtain a product for release with an
epinephrine assay within USP specifications near to 100%
according to labeled amount.‖
 Regarding CoPP, the firm has submitted that
―The certificate of pharmaceutical product is not legally defined in
Mexico, however, the legislation issues currently its equivalent
document which is a free sale certificate (FSC) for health inputs
which includes all information contained in a Certificate of
Pharmaceutical Product.”
 Original Legalized free sale certificate issued by Ministry Of
Health, Federal commission for the protection against Health
Risks, Mexico
Issued on: 15-01-2019
 Original, legalized Declaration letter dated 01-02-2019 from M/s.
Laboratorios Zeyco s.a. de C.V. Camino a santa ana tepetitlan
no. 2230 colonia santa ana tepetitlan 45230 zapopan jalisco,
Mexico do hereby declare to export to the territory of the Islamic
Republic of Pakistan through our distributor Mehran Dental
Supplier.
● Copy of GMP certificate of the manufacturer is submitted
which is issued on 31-07-2017. Certificate No:
173300516A0786. Valid till April, 2019.
● Valid Legalized copy of GMP certificate is required.
 Submission of original, valid legalized GMP certificate
 Submission of details of drug sale license.
Case No. 07: Registration Applications of Drugs for Which Stability Study Data is
Submitted.
a. Deferred cases
1859. Name and address of manufacturer / M/s Seraph Pharmaceutical Plot No. 210, Industrial Triangle,
Brand Name +Dosage Form + Strength Serbica 20mg capsule
Composition Each capsule contains;
Isotretinoin…....20mg
Diary No. Date of R& I & fee 08-06-2017 / Dy No. 5155 / Rs.20,000/-
Pharmacological Group AntiAcne
Type of Form Form 5
Pack size & Demanded Price 30‘s, 20‘s, 10‘s, 5‘s / As per SRO
Approval status of product in Reference Absorica 20mg capsule by Ranbaxy Laboratories
Me-too status Atractin by Genome
GMP status New License (Inspection Date: 8th May 2017)
th
Decision of previous meeting:  Deferred for confirmation of manufacturing
process/facility for applied formulation/dosage form as
decided by Registration Board for this product (M-271)
 Deferred for clarification of submitted manufacturing
method for applied formulation particularly how
nitrogen purging will be carried out during
manufacturing of hard gelatin capsules and justification
in light of decision of 250th meeting (M-275)
Evaluation by PEC:  Firm has replied that they have applied as per the
formulation and specification of Absorbica capsule in
hard gelatin which is formulated with appropriate
oleaginous vehicles for stability and efficient
antioxidants to prevent the product from oxidation.
 The filling of capsules will be carried out by semi-
automatic capsule filling machine and after filling
empty capsule shells in dyes, the cap and body of shells
will be seprated and the body will be nitrogen purged by
nozzles of cylinders containing nitrogen. After purging
the material will be immediately filled in body of
capsule shells and capsule will be locked immediately
to minimize the air contact.
 The formulation as per annovator containing oleaginous
vehicles and antioxidants itself is sufficient for stability
of product and that the nitrogen purging is an additional
precautionary step for product stability.
Decision of previous meeting: The Board deferred the case for further evaluation. (M-277)
The firm has submitted that the product was formulated with appropriate oleaginous vehicles for stability
and with efficient antioxidants in order to prevent the product from oxidation. To ensure this firm has
conducted accelerated and real time stability study data and submitted it along with required documents as
per checklist approved in 251st meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 31426 dated 18-09-2018)
Drug Serbica 20mg capsule
Name of Manufacturer M/s Seraph Pharmaceutical Plot No. 210, Industrial Triangle, Kahuta Road,
Islamabad
Manufacturer of API Shanghai New Hualian Pharmaceutical Co. Ltd. No.217, Minle Road, Spark
Zone, Haiwan Town, Fengxian District Shanghai.
API Lot No. C014-171106
Description of Pack
3x10‘s: Alu-Alu blister packed in cardboard unit carton
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. T-001 T-002 T-003
Batch Size 500 capsule 500 capsule 500 capsule

No. of Batches 03
Date of Submission (Dy.# 31426 dated 18-09-2018)
1. COA of API Yes
Approval of API by regulatory authority of
country of origin or GMP certificate of API Firm has submitted GMP certificate (No. SH20150008)
2.
manufacturer issued by regulatory authority of issued by state Food and Drug Administration China
country of origin.
Protocols followed for conduction of stability
3. Yes
Data of 03 batches will be supported by attested
4. respective documents like chromatograms, Yes
Firm has submitted copy of Packing list, invoice, Form
7, Form 3, COA and DHL invoice for import of 50g
Isotretinoin on 26-01-2018from Shanghai New Hualian
Pharmaceutical through Kimwell Pharma Limited.
All provided documents will be attested (name,
6. sign and stamp) for ensuring authenticity of data / Yes
documents.
Commitment to continue real time stability study
7. Yes
Commitment to follow Drug Specification Rules,
8. Yes
1978.
 Firm has used BP method for testing of the finished product which is based on analytical methods of UV
spectroscopy, furthermore the BP monograph is for isotretinoin soft gelatin capsule.
Report on investigation of genuineness / authenticity of data submitted for registration of SERBICA Capsule 20mg
(Isotretinoin Hard Gelatin Capsule 20mg) by M/s Seraph Pharmaceutical, Islamabad.
Reference No: F.13-11/2017-PEC (Pt) dated 29th October, 2018.
Investigation Date: 27th December, 2018.
Investigation Site: M/s Seraph Pharmaceutical Plot No. 210, Industrial Triangle, Kahuta Road, Islamabad.
Background:
The Chairman Registration Board approved the following panel for on-site investigation to confirm genuineness /
authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities
etc. in addition to verify and report about the following point for consideration of Registration Board:
i. Firm has used BP method for testing of the finished product which is based on analytical methods of UV
spectroscopy. Furthermore, the BP monograph is for isotretinoin soft gelatin capsule.
1. Dr. Hafsa Karam Elahi, Additional Director, QA&LT-I, DRAP Islamabad
2. Mr. Muhammad Tahir Waqas, Assistant Director (QA&LT), DRAP Islamabad
3. Mst. Haleema Sharif, Assistant Director (PEC), DRAP Islamabad
Investigation to confirm genuineness / authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities etc.


Detail of Investigation:
Q.
No.
1. Do you have documents confirming the Firm have shown copy of DHL invoice for import of 50g
import API including approval from Isotretinoin on 26-01-2018 from Shanghai New Hualian
DRAP? Pharmaceutical through Kimwell Pharma limited.
2. What was the rationale behind selecting the Firm informed that they have selected API‘s supplier on
particular manufacturer of API? the basis of GMP Certification & CEP Certification for
Isotretinoin from EDQM (R1-CEP 2008-231-Rev 01) and
Vendor Prequalification (Desktop).
3. Do you have documents confirming the The firm had analyzed using Reference Absorbance value
import of API reference standard and of Standard given in BP Monograph.
impurity standards?
4. Do you have certificate of Analysis of the Firm have Certificate of Analysis of the API (Batch No.
API, reference standards and impurity C014-171106).
standards?
5. Do you have GMP certificate of API Firm have copy of GMP certificate No. SH20150008 of
manufacturer issued by regulatory authority M/s Shanghai New Hualian Pharmaceutical Co., Ltd.,
of country of origin? China issued by State Food and Drug Administration,
China.
6. Do you use API manufacturer method of Firm have used BP Method for testing of API
testing for testing API? (Isotretinoin) whereas the API Manufacturer have used
USP-36 Monograph.
7. Do you have stability studies reports on Firm have shown copy of 06 Months (Accelerated) and 36
API? Months (Real Time) Stability Study Reports on 03 Batches
of API (Isotretinoin) conducted by the API Manufacturer.
8. If yes, whether the stability testing has been The stability testing has been performed as per SIM
performed as per SIM method and method.
9. Do you have method for quantifying the Firm have method for quantifying the impurities in the
impurities in the API? API.
10. Do you have some remaining quantities of Firm have 15 gm of the API (Isotretinoin) remaining.
the API, its reference standard and
11. Have you used pharmaceutical grade Firm have used pharmaceutical grade excipients:
excipients?  Avicel 102
 Stearoyl polyoxyl glyceride
 Soybean oil
 Tween 80
 Propyl gallate
12. Do you have documents confirming the Firm has shown documents confirming the import of the
import of the used excipients? used excipient (Avicel 102); others were purchased locally.
13. Do you have test reports and other records Firm have test reports and other records on the excipients
on the excipients used? used.
14. Do you have written and authorized Firm have shown a generalized protocol for the
protocols for the development of applied development of new products.
product? Firm was advised to adopt SOP for Product Specific New
Product Development Protocol.
15. Have you performed Drug-excipients Firm have not performed Drug-excipients compatibility
compatibility studies? studies and claims to use same excipients as that of
Innovator (ABSORICA™).
16. Have you performed comparative Firm have performed comparative study of their product
dissolution studies? with ABSORICA™ Hard Gelatin Capsule 20mg. Details
are as follows:

Details Test Reference
Product Product
Brand SERBICA ABSORICA™
Batch No. T001 10-3243
Mfg. Date 2/2018 2/2018
Medium 900ml of 0.1M 900ml of 0.1M
of NaOH at of NaOH at
37°C. 37°C.
Remarks: The analysis was performed using BP
Method for Dissolution Testing in DT apparatus.
Test product showed comparable results with the reference
product.
17. Do you have product development (R&D) Firm have product development (R&D) section.
section?
18. Do you have necessary equipment available Firm have necessary equipment available in product
in product development section for development section for development of applied product.
development of applied product? However capsule filling was done in Production area using
Semi-automatic Capsule Filling Machine tailored with
nozzles of cylinders containing Nitrogen for purging.
19. Are the equipment in product development The equipment in product development section were
section qualified? qualified.
20. Do you have proper maintenance / Firm have proper maintenance / calibration / re-
21. Do you have qualified staff in product RND Manager (Pharmacist, 08 years exp.) is involved in
development section with proper knowledge Product Development (RND).
22. Have you manufactured three stability Three (03) stability batches have been manufactured in 02-
batches for the stability studies of applied 2018 for the stability studies of applied product having
product as required? batch size of 500 capsules each.
23. Do you have any criteria for fixing the batch Keeping in view the DRAP‘s criteria, guidelines and no. of
size of stability batches? units required for test / analysis the firm had developed a
criteria for fixing batch size of stability batches.
24. Do you have complete record of production Firm have shown record of production of stability batches.
of stability batches?
25. Do you have protocols for stability testing Firm have detailed protocols for stability testing of
of stability batches? stability batches.
26. Do you have developed and validated the Firm have used BP Method and conducted Analytical
method for testing of stability batches? Method Verification using 04 parameters.
27. Do you have method transfer studies in case Not applicable.
28. Do you have documents confirming the Firm have documents confirming the qualification of
qualification of equipment / instruments equipment / instruments being used in the test and analysis
being used in the test and analysis of API of API and the finished drug.
29. Is your method of analysis stability Firm have used BP Method for testing of FPP however
indicating? Impurity profiling was not performed.
30. Is your HPLC software 21CFR Compliant? No. The analysis was performed using UV-1601
Spectrophotometer (Schimadzu, BIOSPEC).
31. Can you show Audit trail reports on The log book of UV-1601 Spectrophotometer (Schimadzu,
stability study testing? BIOSPEC) was checked and submitted documents were
cross verified.
32. Do you have some remaining quantities of No degradation products.
degradation products and stability batches? Stability batches are kept on Real Time Stability Testing.
33. Do you have stability batches kept on Firm have stability batches kept on Real Time Stability
stability testing? Testing.
34. Do you have valid calibration status for the Firm have valid calibration status for the equipment used
equipment used in production and analysis? in production and analysis.
35. Do proper and continuous monitoring and Adequate monitoring and control are available for stability
control are available for stability chamber? chambers (China Chong Qing Chuang, CSH-2225D-C)
with built-in Digital Data Loggers.
Power backup has been ensured with UPS & 150kV
Generator.
36. Do related manufacturing area, equipment, Related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are as per cGMP compliance.
compliant?
37. To verify and report about the following The panel verifies that the Firm has used BP method for
point for consideration of Registration testing of the finished product which is based on analytical
Board: methods of UV spectroscopy.
~Firm has used BP method for testing of the
finished product which is based on Moreover, the BP Monograph does not specify whether it
analytical methods of UV spectroscopy. can only be used for isotretinoin soft gelatin capsule.
Furthermore, the BP monograph is for Submitted for consideration of Registration Board.
isotretinoin soft gelatin capsule.
CONCLUSION:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of SERBICA Capsule 20mg (Isotretinoin Hard Gelatin Capsule 20mg) is verifiable to satisfactory
level.
Previous Decision: Registration Board deliberated that since applied formulation is prone to oxidation, and is
likely to undergo degradation, hence 6 months stability data could not be considered sufficient to ascertain shelf
life of 2 years. Therefore Registration Board directed the firm to submit Long term stability studies data for one
year. Moreover Board directed the firm to justify the use of UV spectroscopy instead of HPLC for Assay analysis
of applied formulation (M-287).
Evaluation by PEC: The firm has submitted that rationale behind the use of UV method is that;
As we are using the testing method defined in British Pharmacopoeia and the method given in British
Pharmacopoeia for the analysis of capsule is UV method. Hence we have tested the product as per British
Pharmacopoeia monograph.
The firm has submitted real time stability study data of 9th and 12th month time points of three trial batches.
Decision: Registration Board deferred the case for provision of real time stability data upto assigned shelf
life.

a. Exemption from onsite verification of stability data
Deferred cases:
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability
1860. M/s Shaigan Tikanox-60 Tablets Form 5-D Brilinta Tablet of Astrazeneca
Pharmaceuticals, Pharms
14-Km, Adyala Each Film coated tablet Dairy No.1984 dated (USFDA approved)
Road, Post Office contains: 25-05-2016,
Dahgal, Rawalpindi Ticagrelor…...60mg Rs.50,000/-, N/A
24-05-2016, Last GMP inspection was
Platelet activation Not mentioned conducted on 14-12-2017 The
inhibitor company is found complying
CGMP as of today and panel
Manufacturer‘s unanimously agreed to issue
specifications CGMP certificate for export
along with COPP, The
management was advised to
continue the process of up
gradation.
Drug Tikanox-60 Tablets
Rawalpindi
Manufacturer of API M/s Glenmark Pharmaceuticals Ltd. Gujarat, India
Description of Pack PVC Blister of 1×10‘s pack
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 weeks
Batch No. T-001 T-002 T-003
No. of Batches 03
1. COA of API. Copy of COA (Batch# 82160137) from M/s
Glenmark Pharmaceuticals Ltd. Gujarat, India is
submitted.

2. Approval of API by regulatory authority of Copy of GMP certificate issued by Food and Drugs
country of origin or GMP certificate of API Administration, Maharashtra State, India (Certificate
manufacturer issued by regulatory authority of No 6081505) has been submitted. It is valid until 03-
country of origin. 05-2019.

for the import of 600g of Ticagrelor
(Invoice#2007000394) attested by ADC DRAP,
Islamabad dated 08-09-2016.
documents.
1978.
● The firm has submitted 26 weeks Accelerated and 26 weeks Real Time Stability Data for 03 Batches.
Meeting:
Date of submission: 1213 vide diary no. 10-01-2019
1. Reference of last onsite panel inspection for The firm has submitted reference of already approved
instant dosage form conducted during last two product in 285th meeting the decision as:
years. Registration Board decided to approve registration of
Vebuvir Tablets 400 mg (Sofosbuvir) of M/s Shaigan
Pharmaceuticals (Pvt) Ltd, 14 km, Adyala road, post
office Dahgal, Rawalpindi. Manufacturer will place first
three production batches of both products on long term
stability studies throughout proposed shelf life and on
The firm has provided USB data loggers, which are set
for recording temperature and humidity after each hour.
2. Documents for the procurement of API with The firm has submitted copy of commercial invoice for
approval from DRAP (in case of import). the import of 600g of Ticagrelor (Invoice#2007000394)
attested by ADC DRAP, Islamabad dated 08-09-2016.
3. Documents for the procurement of reference The firm has submitted copy of commercial invoice for
standard and impurity standards. the procurement of working standards.
4. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by Food and Drugs
manufacturer issued by regulatory authority of Administration, Maharashtra State, India (Certificate No
country of origin. 6081505) has been submitted. It is valid until 03-05-
2019.
5. Mechanism for Vendor pre-qualification The firm has submitted Mechanism for Vendor pre-
qualification.
6. Certificate of analysis of the API, reference  Copy of COA (Batch# 82160137) from M/s.
standards and impurity standards Glenmark Pharmaceuticals Ltd. Gujarat, India is
submitted.
 Copy of COA of working standards have been
submitted
 COAs of impurity standards have been
submitted.
Impurity A
Impurity B
Impurity C
used in product development? invoices/COAs of the excipients used in the formulation
of applied product
development with relevant experience. in product development department.
Production Data
9. Authorized Protocols/SOP for the development The firm has submitted photocopy of ―Protocols/SOP
& stability testing of trial batches. for the Development of ―Excel Tablets 40mg‖.
stability batches. Manufacturing Records of following 03 Batches:
T-001 1000 Tablets 07-2017
T-002 1000 Tablets 07-2017
T-003 1000 Tablets 07-2017
11. Record of remaining quantities of stability
batches. Trial No Total no. Tablets Remaining
of Tablets used for Quantities
For testing of tablets
stability
testing
T-001 866 232
T-002 881 634 247
T-003 871 237
QA / QC DATA
12. Record of Digital data logger for temperature and Firm has submitted photocopies of digital data logger
humidity monitoring of stability chambers (real record for Accelerated stability chamber and Real Time
time and accelerated) stability chamber starting from 18-07-2017 to 06-02-
2018.
with COA for Ticagrelor.
record of testing of stability batches (i.e. Testing Procedure for ―Tikanox-60 Tablets‖ along with
chromatograms, lab reports, raw data sheets etc.) Stability Study Reports.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated (40oC±2oC/75%±5%RH) and 36 Months
Real Time (25oC±2oC/60%±5%RH) Stability Study
Data of 03 Batches for Ticagrelor from M/s Glenmark
Pharmaceuticals Ltd. Gujarat, India
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports
of excipients used.
17. Drug-excipients compatibility studies. The firm has submitted that ingredients of Tikanox-60
Tablets and Brilinta 60mg Tablet (innovator brand) are
same.
18. Record of comparative dissolution data. The firm has performed comparative dissolution studies
with Brilinta 60mg Tablets manufactured by M/s.
Astrazeneca Pharms, USA (Batch#JP0010, EXP 02/20).
The firm‘s product (Tikanox-60 Tablets) results are
comparable with BRILINTA 60mg Tablets.
19. Compliance Record of HPLC software 21CFR & The firm has submitted audit trail reports of Tikanox-60
audit trail reports on product testing. Tablets from 11-08-2017 to 26-01-2018.
The storage conditions under which real time stability studies of API were conducted are not as per Zone IVA.
The firm has not performed comparative dissolution profiling at pH 1.2, pH 4.5 and pH 6.8.
Previous Decision: Registration Board deferred the case for submission of stability data of API from supplier
conducted at Zone IV-A conditions and submission of comparative dissolution profiling at pH 1.2, pH 4.5 and
pH 6.8 (M-288).
Evaluation by PEC:
The firm has submitted long term stability data of three batches of API conducted at Zone IV-A.
The firm has performed comparative dissolution studies conducted at pH 1.2, pH 4.5, pH 6.8 with Brilinta 60mg
Tablets manufactured by M/s. Astrazeneca Pharms, USA ((Batch#JP0010, EXP 02/20). The firm‘s product
(Tikanox-60 Tablets) results are comparable with BRILINTA 90mg Tablets.
Decision: Registration Board deferred the case for confirmation of polymorphic form of API Ticagrelor.
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability
Finished Product Pack size Remarks
Specification
1861.
M/s Shaigan Tikanox-90 Tablets Form 5-D Brilinta Tablet of Astrazeneca
Pharmaceuticals, Pharms
14-Km, Adyala Each Film coated tablet Dairy No.1985 dated (USFDA approved)
Road, Post Office contains: 25-05-2016, N/A
Dahgal, Rawalpindi Ticagrelor…...90mg Rs.50,000/-, Last GMP inspection was
24-05-2016, conducted on 14-12-2017 The
Platelet activation Not mentioned company is found complying
inhibitor CGMP as of today and panel
unanimously agreed to issue
Manufacturer‘s CGMP certificate for export
specifications along with COPP, The
management was advised to
continue the process of up
gradation.
Drug Tikanox-90 Tablets
Rawalpindi
Manufacturer of API M/s Glenmark Pharmaceuticals Ltd. Gujarat, India
Description of Pack PVC Blister of 1×10‘s pack
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 weeks
Batch No. T-001 T-002 T-003
th
No. of Batches 03
No.
1. COA of API. Copy of COA (Batch# 82160137) from M/s
Glenmark Pharmaceuticals Ltd. Gujarat, India is
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate issued by Food and Drugs
country of origin or GMP certificate of API Administration, Maharashtra State, India (Certificate
manufacturer issued by regulatory authority of No 6081505) has been submitted. It is valid until 03-
country of origin. 05-2019.

for the import of 600g of Ticagrelor
(Invoice#2007000394) attested by ADC DRAP,
Islamabad dated 08-09-2016.
documents.
1978.
● The firm has submitted 26 weeks Accelerated and 26 weeks Real Time Stability Data for 03 Batches.
the following documents in conjunction with the checklist approved by the Registration Board in its 278th
Meeting:
Date of submission: 1213 vide diary no. 10-01-2019
1. Reference of last onsite panel inspection for The firm has submitted reference of already approved
instant dosage form conducted during last two product in 285th meeting the decision as:
years. Registration Board decided to approve registration of
Vebuvir Tablets 400 mg (Sofosbuvir) of M/s Shaigan
Pharmaceuticals (Pvt) Ltd, 14 km, Adyala road, post
office Dahgal, Rawalpindi. Manufacturer will place first
three production batches of both products on long term
stability studies throughout proposed shelf life and on
The firm has provided USB data loggers, which are set
for recording temperature and humidity after each hour.
2. Documents for the procurement of API with The firm has submitted copy of commercial invoice for
approval from DRAP (in case of import). the import of 600g of Ticagrelor (Invoice#2007000394)
attested by ADC DRAP, Islamabad dated 08-09-2016.
3. Documents for the procurement of reference The firm has submitted copy of commercial invoice for
standard and impurity standards. the procurement of working standards.
4. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by Food and Drugs
manufacturer issued by regulatory authority of Administration, Maharashtra State, India (Certificate No
country of origin. 6081505) has been submitted. It is valid until 03-05-
2019.
5. Mechanism for Vendor pre-qualification The firm has submitted Mechanism for Vendor pre-
qualification.
6. Certificate of analysis of the API, reference 
Copy of COA (Batch# 82160137) from M/s.
standards and impurity standards Glenmark Pharmaceuticals Ltd. Gujarat, India is
submitted.
 Copy of COA of working standards have been
submitted
 COAs of impurity standards have been
submitted.
Impurity A
Impurity B
Impurity C
used in product development? invoices/COAs of the excipients used in the formulation
of applied product
development with relevant experience. in product development department.
Production Data
9. Authorized Protocols/SOP for the development The firm has submitted photocopy of ―Protocols/SOP
& stability testing of trial batches. for the Development of ―Tikanox-90 Tablets‖.
stability batches. Manufacturing Records of following 03 Batches:
T-001 1000 Tablets 07-2017
T-002 1000 Tablets 07-2017
T-003 1000 Tablets 07-2017
11. Record of remaining quantities of stability
batches. Trial No Total no. Tablets Remaining
of Tablets used for Quantities
For testing of tablets
stability
testing
T-001 874 240
T-002 878 634 244
T-003 870 236
QA / QC DATA
12. Record of Digital data logger for temperature and Firm has submitted photocopies of digital data logger
humidity monitoring of stability chambers (real record for Accelerated stability chamber and Real Time
time and accelerated) stability chamber starting from 18-07-2017 to 06-02-
2018.

with COA for Ticagrelor.
record of testing of stability batches (i.e. Testing Procedure for ―Tikanox-90 Tablets‖ along with
chromatograms, lab reports, raw data sheets etc.) Stability Study Reports.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated (40oC±2oC/75%±5%RH) and 36 Months
Real Time (25oC±2oC/60%±5%RH) Stability Study
Data of 03 Batches for Ticagrelor from M/s Glenmark
Pharmaceuticals Ltd. Gujarat, India
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports
of excipients used.
17. Drug-excipients compatibility studies. The firm has submitted that ingredients of Tikanox-90
Tablets and Brilinta 90mg Tablet (innovator brand) are
same.
18. Record of comparative dissolution data. The firm has performed comparative dissolution studies
with Brilinta 90mg Tablets manufactured by M/s.
Astrazeneca Pharms, USA (Batch#JP0010, EXP 02/20).
The firm‘s product (Tikanox-90 Tablets) results are
comparable with BRILINTA 90mg Tablets.
19. Compliance Record of HPLC software 21CFR & The firm has submitted audit trail reports of Tikanox-60
audit trail reports on product testing. Tablets from 11-08-2017 to 26-01-2018.
The storage conditions under which real time stability studies of API were conducted are not as per Zone IVA.
The firm has not performed comparative dissolution profiling at pH 1.2, pH 4.5 and pH 6.8.
Previous Decision: Registration Board deferred the case for submission of stability data of API from supplier
conducted at Zone IV-A conditions and submission of comparative dissolution profiling at pH 1.2, pH 4.5 and
pH 6.8 (M-288).
Evaluation by PEC:
The firm has submitted long term stability data of three batches of API conducted at Zone IV-A.
The firm has performed comparative dissolution studies conducted at pH 1.2, pH 4.5, pH 6.8 with Brilinta 90mg
Tablets manufactured by M/s. Astrazeneca Pharms, USA ((Batch#JP0010, EXP 02/20). The firm‘s product
(Tikanox-90 Tablets) results are comparable with BRILINTA 90mg Tablets.
Decision: Registration Board deferred the case for confirmation of polymorphic form of API Ticagrelor.

MISCELLENEOUS CASES:
REGISTRATION-I
Case No.1. Request For Change in Registration Status of Products From M/s AGP Ltd,
Karachi To M/s. Aspin Pharma, Karachi.
Registration Board in its 288th meeting considered the request of M/s. Aspin
Pharma (Pvt.) Ltd; Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900 for
change of registration status of following products from M/s. AGP Ltd; Karachi to their name
through contract manufacturing by M/s. AGP Ltd; B-23, S.I.T.E, Karachi. The details are given
as under:
Approved Registration
S.No. Reg.No. Name of Drug(s) Remarks
Pack/MRP History
I II III IV V VI
1 055121 Xovat 5mg Tablet Rs. 120.00/ Initial date of Dy.No.3395
Each tablet contains: 10‘s Reg. 11-02-2019
Rosuvastatin as calcium ….5mg 02-03-2009 Rs.70,000/-
(Manufacturer Specifications) Last Renewal Standard Formulation
02-03-2014 approved by RRAs is
film coated.
Rosuvastatin as calcium 02-03-2009 Rs.70,000/-
….10mg Last Renewal Standard Formulation
(Manufacturer Specifications) 02-03-2014 approved by RRAs is
film coated.
Rosuvastatin as calcium 02-03-2009 Rs.70,000/-
….20mg Last Renewal Standard Formulation
(Manufacturer Specifications) 02-03-2014 approved by RRAs is
film coated.
Rosuvastatin as calcium….20mg 26-09-2017 Rs.70,000/-
(As per Innovators Standard Formulation
Specifications) approved by RRAs is
film coated.
The management of the firm has provided following documents:-

i. Application on Form-5 with original fee challan of Rs. 70,000/- for each product.
ii. Copies of initial letters of registration as stated in column V above table.
iii. Section (Tablet General) approval of M/s AGP from Licensing Division dated 28-4-2016.
iv. Copy of last GMP inspection of M/s AGP, dated 16-10-2018, indicating ―Good‖ level.
v. NOC from M/s. AGP Ltd; Karachi 29-01-2019.
vi. DML of M/s Aspin dated 31st May, 2015
vii. DML of M/s AGP, Karachi dated 06-02-2015.
viii. Undertakings in the light of SOPs approved vide M-283.
ix. Contract Agreement of M/s. AGP Limited, Karachi and M/s Aspin, Karachi.
Decision of M-288:
i. Cancellation of registration of products at S.No. 1-4from the name of M/s. AGP
Ltd; B-23, S.I.T.E, Karachi.

ii. Approved registration of products at S.No. 1-4 in the name of M/s. Aspin Pharma
(Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900
through contract manufacturing by M/s. AGP Ltd; B-23, S.I.T.E, Karachi.
Furthermore, formulations shall be standardized in accordance with that
approved by Reference Regulatory Authorities.
iii. Reference will be sent to Cost and Pricing Division for confirmation of maximum
retail price (MRP).
Furthermore, M/s Aspin, Karachi has 04 approved sections, therefore, entitled to contract
manufacturing of 20 products as per policy of 5 products per section.
Now the firm has submitted a request stating that:
“Due to restriction of maximum 20 contract manufacturing of products as per contract
manufacturing policy, we here by request your good office to withdraw the above
mentioned products for transfer of registration via contract manufacturing and consider
these applications null and void”
Decision: Registration Board acceded to the request of M/s. Aspin Pharma (Pvt.) Ltd,
Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900 for
withdrawal of their previously submitted application regarding change in
registration status of above mentioned products via contract manufacturing.
Decision taken in 288th meeting shall stand void ab initio.
Case No.2. Request for Change in Registration Status of Products From M/s OBS
Pakistan (Pvt.) Ltd, Karachi To M/s. Aspin Pharma, Karachi.
Registration Board in its 288th meeting considered the request of M/s. Aspin Pharma
(Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900 for change of
registration status of following products from M/s. OBS Pakistan (Pvt.) Ltd; Karachi to their
name through contract manufacturing by M/s. OBS Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi.
The details are given as under:
Approved Registration Dy.No, Date &
S.#. Reg.# Name of Drug(s)
Pack/MRP History Fees/Remarks
I II III IV V VI
1 093005 Gabolest Capsule 25mg Rs.121.00/ Initial date of Dy.No.3393
Each capsule contains: 14‘s Reg. 08-02-2019
Pregabalin .... 25mg 31-12-2018 Rs.70,000/-
(As per Innovator's Specifications)
Pregabalin ... 50mg 31-12-2018 Rs.70,000/-
Pregabalin .... 100mg 31-12-2018 Rs.70,000/-
Pregabalin .... 200mg 31-12-2018 Rs.70,000/-
Pregabalin .... 225mg 31-12-2018 Rs.70,000/-
Pregabalin ..... 150mg 23-01-2015 Rs.70,000/-
Pregabalin ..... 300mg 23-01-2015 Rs.70,000/-
Pregabalin .... 75mg 23-01-2015 Rs.70,000/-
9 089147 Kapdex 30mg Capsule Rs.451.00/ Initial date of Dy.No.3383
Dexlansoprazole dual delayed release 31-05-2018 Rs.70,000/-
pellets eq. to Dexlansoprazole…30mg Pellets registered
(As per Innovator‘s Specification) source: M/s
Vision
Pharmaceuticals,
Islamabad
10 089148 Kapdex 60mg Capsule Rs.696.00/ Initial date of Dy.No.3382
Dexlansoprazole dual delayed release 31-05-2018 Rs.70,000/-
pellets eq. to Dexlansoprazole..60mg Pellets registered
(As per Innovator‘s Specification) source: M/s
Vision
Pharmaceuticals,
Islamabad
11 075821 Virunix-B 1mg Tablet Rs. 17000.00/ Initial date of Dy.No.3384
Each film coated tablet contains: 30‘s Reg. 08-02-2019
Entecavir as monohydrate ...1mg 03-04-2013 Rs.70,000/-
(Manufacturer Specifications ) Renewal USP Monograph
18-01-2018 is available for
applied
formulation
12 075822 Virunix-B 0.5mg Tablet Rs. 9000.00/ Initial date of Dy.No.3385
Each film coated tablet contains: 30‘s Reg. 08-02-2019
Entecavir as monohydrate...0.5mg 03-04-2013 Rs.70,000/-
(Manufacturer Specifications ) Renewal USP Monograph
18-01-2018 is available for
applied
formulation
ii. Copies of initial letters of registration and renewal status as stated in column V above
table.
iii. Tablet (General) Section approval of M/s. OBS Pakistan (Pvt.) Ltd; Karachi verified from
Licensing Division‘s letter for renewal of DML (dated 08 th July, 2015) & Capsule
(General) vide licensing Division letter no.F-2-1/2000-Lic(Vol-I) dated 13-04-2018.
iv. Copy of last GMP inspection report of M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 06th
November, 2018 indicating ―Good‖ level.
v. NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 28 th January, 2019.
vi. Consent/NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 28 th January, 2019 for
Contract manufacturing of above mentioned products.
vii. DML of M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 31 st March, 2015.
viii. DML of M/s Aspin dated 31st May, 2015
ix. Undertakings in the light of SOPs approved vide M-283.
x. Copy of Contract Agreement of M/s. OBS Pakistan (Pvt.) Ltd; Karachi. and M/s Aspin

The Board was further informed that M/s Aspin Pharma, Karachi has 04 sections,
therefore, entitled for contract manufacturing of 20 products as per policy of 5 products per
section while the firm has already been granted registration of 04 products.
Decision of M-288:
i. Cancellation of registration of products at S.No. 1-12 from the name of M/s. OBS
Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi.
ii. Approved registration of products at S.No. 1-12 in the name of M/s. Aspin
Pharma (Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi Industrial Area
Karachi-74900 through contract manufacturing by M/s. OBS Pakistan (Pvt.) Ltd;
C-14, S.I.T.E, Karachi.
iii. Reference will be sent to Cost and Pricing Division for confirmation of maximum
retail price (MRP).
Now the firm has submitted a request stating that:
―Due to restriction of maximum 20 contract manufacturing of products as per contract
manufacturing policy, we here by request your good office to withdraw our previous
applications and consider above mentioned products for complete Marketing
authorization/ Registration transfer of products from OBS Pakistan Pvt. Ltd to M/s Aspin
Pharma Pvt. Ltd. located at Plot No. 10 & 25, Sector 20, Korangi Industrial Area
Karachi-74900. Pakistan. (Dy.No.265 to 276/DDC (Reg-I) dated 17-04-2019)
The firm has also submitted fresh fee of Rs.20,000/- each for product at Sr.No.09-10
(Dy.No 419 & 420/DDC(Reg-I) dated 03-05-2019)(Source of pellets: M/s Vision
Pharma, Islamabad)
Decision: Registration Board acceded to the request of M/s. Aspin Pharma (Pvt.) Ltd,
Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900 and
decided as follows:
i. Cancellation of registration of products at S.No. 1-8 & 11-12from the
name of M/s. OBS Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi.
ii. Approved registration of products at S.No. 1-8 & 11-12in the name of
M/s. Aspin Pharma (Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi
Industrial Area Karachi-74900.
iii. Reference will be sent to Cost and Pricing Division for confirmation of
maximum retail price (MRP).
iv. Deferred the request w.r.t products at S.No.9-10 for submission of
stability data& associated documents.
v. Decision taken in 288th meeting shall stand void ab initio.
Case No.03: Request of M/s. Aspin Pharma, Karachi for Change in Registration Status of
Products of M/s. OBS Pakistan (Pvt) Ltd, Karachi.
Registration Board, in its 287thmeeting held on 03-04th January,2019, deferred the
request of M/s. Aspin Pharma (Pvt.) Ltd; Plot No.10 & 25, Sector 20, Korangi Industrial Area
Karachi-74900 for change of registration status of following product from M/s. OBS Pakistan
(Pvt.) Ltd; Karachi to their namefor submission of source of Mebeverine extended release
pellets, by the firm.Details are given as under:
Name of Drug(s) with Approved Registration
S.No. Reg.No. Remarks
composition Pack/ MRP History
I II III IV V VI
Bever-M 200mg Capsule 084748 Rs.142/10‘s Initial date of Documents related
1.
Each capsule contains: Reg. to source of pellets
Mebeverine HCI as extended 09-08-2017 along with
release pellets eq. to Mebeverine differential fee of
HCl ..............200mg Rs.80,000 are yet
(Innovator's Specification) to be provided.
Source: M/s RA Chem Pharma
Ltd, India

i. Original challan Fee of Rs. 20,000/- for each product.
ii. Copies of initial letters of registration and renewal status as stated in column V above.
iii. Section approval of M/s Aspin verified from Licensing Division‘s letter for renewal of
DML (dated 09th June, 2016) confirming following sections;
 Tablet (General)
 Capsule (General)
 Liquid Syrup
 Ointment/ Cream.
iv. Copy of last GMP inspection report of M/s Aspin, Karachi dated 08 th August, 2018
indicating ―Satisfactory‖ level.
v. NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 19th November, 2018.
vi. DML of M/s Aspin dated 31st May, 2015.
The firm has now submitted requisite documents (Copy of GMP, COA and stability
Studies)for source of Mebeverine Pellets from M/s RA Chem Pharma Ltd. India along with fee
of Rs.100,000/-(Dy.135/DD(R-I) dated 19-Mar-19)
Decision: Registration Board decided as follows:

i. Cancellation of registration of Bever-M 200mg Capsule (R#084748)
from the name of M/s. OBS Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi.
ii. Approved registration of Bever-M 200mg Capsule in the name of M/s.
Aspin Pharma (Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi
Industrial Area Karachi-74900.
maximum retail price (MRP). Furthermore, Registration certificate
shall be issued after submission of valid & legalized GMP certificate of
M/s RA Chem Pharma Ltd. India.
Case No.4. Request for Change in Registration Status of Products from M/s OBS
Pakistan (Pvt.) Ltd, Karachi to M/s. Aspin Pharma, Karachi.
(Pvt.) Ltd; Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900 for change of
name through contract manufacturing by M/s. AGP Limited, D-109, S.I.T.E, Karachi (Contract
Manufacturer remain the same). The details are given as under:
S. Approved Registration
Reg.No. Name of Drug(s) Remarks
No Pack/MRP History
I II III IV V VI
1 057942 M-Span 100mg/5ml Dry Rs.180.00/ Initial date of Reg. Dy.No.3414
Suspension 30ml 30-07-2009 via contract 11-02-2019
Each 5ml contains: Manufacturing from M/s Rs.20,000/-
Cefixime as trihydrate...100mg Mediate Pharma Ltd
(USP Specifications)

2 057943 M-Span 200mg/5ml Dry Rs.300.00/ Change of Contract Dy.No.3416
Suspension 30ml Manufacturing to M/s 11-02-2019
Each 5ml contains: Macter International Rs.20,000/-
Cefixime as trihydrate...200mg 07-02-2011
Change of Contract
3 057944 M-Span 400mg Capsules Rs.325.00/ Manufacturing to M/s Dy.No.3415
Each capsule contains: 5‘s AGP Ltd 11-02-2019
Cefixime as trihydrate...400mg 14-12-2015 Rs.20,000/-
(USP Specifications) Permission is valid up to
30-06-2020
ii. Copies of initial letters of registration and renewal status as stated in column V above.
iii. Section approval of M/s. AGP Limited, D-109, S.I.T.E, Karachi.
iv. Copy of last GMP inspection report of M/s. AGP Limited, D-109, S.I.T.E, Karachi dated
09th August, 2018 indicating ―Good‖ level (Sections: Capsule (Ceph), Tablet (Ceph), Dry
suspension (Ceph).
v. NOC from M/s. AGP Pakistan (Pvt.) Ltd; Karachi dated 29th January, 2019.
vi. Consent/NOC from M/s. AGP Limited, D-109, S.I.T.E, Karachi dated 29th January, 2019
for Contract manufacturing of above mentioned products.
vii. DML of M/s Aspin dated 31st May, 2015
viii. DML of M/s AGP, Karachi dated 15-07-2014.
x. Contract Agreement of M/s. AGP Limited, D-109, S.I.T.E, Karachi and M/s Aspin
Decision of M-288: Registration Board deferred the request for submission of requisite fee for
grant of contract manufacturing permission.
The firm has now submitted differential fee of Rs.50,000/- for each product
(Dy.No.1164/ (R&I) dated 19-Mar-19).
i. Cancellation of registration of products at S.No. 1-3from the name of
M/s. OBS Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi.
ii. Approved registration of products at S.No. 1-3in the name of M/s. Aspin
Karachi-74900 through contract manufacturing by M/s. AGP Limited,
D-109, S.I.T.E, Karachi.
Case No.5. Request For Change in Registration Status of Products From M/s OBS
(Pvt.) Ltd; Plot No. 10 & 25, Sector 20, Korangi Industrial Area Karachi-74900 for change of
name through contract manufacturing by M/s. Global Pharmaceuticals Pvt. Ltd; Islamabad
(Contract Manufacturer remain the same). The details are given as under:
Approved Registration
Pack/MRP History
I II III IV V VI
1 089308 Onem IV Injection Rs.776.55/1‘s Date of Reg. in the Dy.No.3399
Each vial contains: name of M/s OBS 11-02-2019
Imipenem Monohydrate Pakistan (Pvt) Ltd, Rs.20,000/-
eq. to Imipenem ….500mg Karachi via contract
Cilastatin Sodium eq. to Manufacturing from
Cilastatin …. 500mg M/s Global
(USP Specifications) Pharmaceuticals Pvt.
Ltd: 29-12-2018
ii. Copies of initial letters of registration as stated in column V above.
iii. Section (Dry Powder Injection Penem) approval verified from panel inspection of M/s
Global for renewal of DML dated 26-12-2018.
iv. Copy of last GMP inspection of M/s Global, dated 26-12-2018.
v. NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi 29-01-2019.
vii. DML of M/s Global, Islamabad dated 26-02-2013 and renewal applied on 11-12-2017.
viii. Consent/NOC from M/s. Global for contract manufacturing dated 29-01-2019.
x. Contract Agreement of M/s. Global, Islamabad and M/s Aspin, Karachi.
Decision of M-288: Registration Board deferred the request for submission of requisite fee for
grant of contract manufacturing permission.
The firm has now submitted differential fee of Rs.50,000/- (Dy.No.1165/ (R&I) dated
19-Mar-19)
i. Cancellation of registration of Onem IV Injection (R# 089308) from
the name of M/s. OBS Pakistan (Pvt.) Ltd, C-14, S.I.T.E, Karachi.
ii. Approved registration of Onem IV Injection in the name of M/s. Aspin
Pharma (Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi Industrial
Area Karachi-74900 through contract manufacturing by M/s. Global
Pharmaceuticals Pvt. Ltd, Islamabad.
M/s. Aspin Pharma (Pvt.) Ltd; Plot No. 10 & 25, Sector 20, Korangi Industrial
Area Karachi-74900 has requested for change of registration status of following products from
M/s. OBS Pakistan (Pvt.) Ltd; Karachi to their name. The details are given as under:
I II III IV V
S.No. Name of Drug(s) Reg.No. Registration Remarks
History
1. Obsarib Capsule 075820 Initial date of Reg. Dy.No7412 (R&I )
Each capsule contains: 03-04-2013 20-02-2019
Ribavirin ........400mg Last Renewal Rs.20,000/-
(Manufacturer‘s specification) 18-01-2018 Duplicate Dossier
2. Obsarib Tablet 081468 Initial date of Reg. Dy.No7414 (R&I )
Each film coated tablet contains: 03-08-2016 20-02-2019
Ribavirin ........600mg Rs.20,000/-
(Manufacturer‘s specification) Duplicate Dossier
3. Obsarib Tablet 081469 Initial date of Reg. Dy.No7413 (R&I )
Each film coated tablet contains: 03-08-2016 20-02-2019
Ribavirin ........500mg Rs.20,000/-
(Manufacturer‘s specification) Duplicate Dossier

4. Fitzloc 250mg Tablet 076293 Initial date of Reg. Dy.No.3309 (R&I )
Each film coated tablet contains: 21-04-2014 11-04.2019
Levetiracetam ........250mg Last Renewal 22-02-2019 Rs.20,000/-
(Manufacturer‘s specification) with fee of Rs.10,000/-
7. C-Yalta 20mg Capsule 076116 Initial date of Reg. Dy.No.3318 (R&I )
Each capsule contains: 25-10-2013 11-04.2019
Duloxetine HCl enteric coated (Source of Pellets: Rs.20,000/-
pellets eq. to Duloxetine … M/s Spansules formulation , Dy.No.4923 (R&I )
20mg India) 30-04.2019
(Manufacturer‘s Specifications) Last Renewal applied on Rs.100,000/-
27-09-2018
With fee of Rs.10,000/-Pellets Applied Source of
are being imported from India Pellets:
and the firm has submitted M/s Spansules, India
renewal fee of Rs.10,000/-
only
pellets eq. to Duloxetine … M/s Spansules formulation , Dy.No.4941(R&I )
60mg India) 30-04.2019
27-09-2018
renewal fee of Rs.10,000/-
only
pellets eq. to Duloxetine … M/s Spansules formulation , Dy.No.4922 (R&I )
30mg India) 30-04.2019
27-09-2018
renewal fee of Rs.10,000/-only
10. C-Yalta 90mg Capsule 070797 Initial date of Reg. Dy.No.3933(R&I )
pellets eq. to Duloxetine … M/s Spansules formulation ,
90mg India) Applied Source of
(Manufacturer‘s Specifications) Last Renewal applied on Pellets:
22-03-2016 with Rs.10,000/- M/s Spansules, India
Pellets are being imported
from India and the firm has
submitted renewal fee of
Rs.10,000/- only
11. Anvol 2.5mg Tablet 081780 Initial date of Reg. Dy.No.2909 (R&I )
Each tablet contains: 07-10-2016 08-04.2019
Nebivolol (as HCl) …..2.5mg Rs.20,000/-
(Manufacturer‘s Specifications)
12. Anvol 5mg Tablet 081069 Initial date of Dy.No.2910 (R&I )
Each tablet contains: Reg. 08-04.2019
Nebivolol (as HCl) …..5mg 22-06-2016 Rs.20,000/-
13. Anvol 10mg Tablet 081781 Initial date of Dy.No.2911 (R&I )
Each tablet contains: Reg. 08-04.2019
Nebivolol (as HCl) …..10mg 07-10-2016 Rs.20,000/-
14. Tracetol Tablet 083188 Initial date of Dy.No.3623 (R&I )
Each film coated tablet contains: Reg. 15-04.2019
Tramadol hydrochloride 15-03-2017 Rs.20,000/-
…37.5mg
Paracetamol…..325mg
15. Angiwell-XR 500mg Tablet 083190 Initial date of Dy.No.3314(R&I )
Each extended release tablet Reg. 11-04.2019
contains: 15-03-2017 Rs.20,000/-
Ranolazine….500mg
(As per innovator‘s
specifications)
16. Angiwell-XR 1000mg Tablet 083191 Initial date of Dy.No.3315(R&I )
Each extended release tablet Reg. 11-04.2019
contains: 15-03-2017 Rs.20,000/-
Ranolazine….1000mg
(As per innovator‘s
specifications)
17. Uricontrol 5mg Tablet 081070 Initial date of Dy.No.3626(R&I )
Solifenacin succinate….5mg 22-06-2016 Rs.20,000/-
18. Uricontrol 10mg Tablet 081071 Initial date of Dy.No.3627 (R&I )

Solifenacin succinate….10mg 22-06-2016 Rs.20,000/-
19. Zerogout 40mg Tablet 081062 Initial date of Dy.No.3624(R&I )
Febuxostat….40mg 22-06-2016 Rs.20,000/-
20. Zerogout 80mg Tablet 081063 Initial date of Dy.No.3625(R&I )
Febuxostat….40mg 22-06-2016 Rs.20,000/-

i. Applications on CTD along with Original Fee challan for each product as mentioned
in Column V.
ii. Copies of initial letters of registration and renewal status as stated in column IV above.
iii. Section approval of M/s Aspin verified from Licensing Division‘s letter for renewal of
DML (dated 09th June, 2016) confirming following sections;
 Liquid Syrup
 Ointment/ Cream.
iv. Copy of last GMP inspection report of M/s Aspin, Karachi dated 08 th August, 2018
indicating ―Satisfactory‖ level.
v. NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 03-April 2019 & 31-12-2018.
i. Cancellation of registration of products at S.No. 2 and 3 from the name of
M/s. OBS Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi.
ii. Approved registration of products at S.No. 2and 3 in the name of M/s. Aspin
Karachi-74900.
iii. Deferred products at S.No. 4-6 & 11-20 as requisite Form 5-F is incomplete.
iv. Reference will be sent to Cost and Pricing Division for confirmation of
maximum retail price (MRP). Furthermore, label claims shall be
standardized (where required) as per standard approved by Reference
v. Deferred the request w.r.t products at S.No.1 for submission of evidence of
approval status of applied formulation by Reference Regulatory Authorities.
vi. Deferred the request w.r.t products at S.No.7-9 for confirmation of renewal
status & submission of complete documents/information regarding source of
pellets.
vii. Deferred the request w.r.t products at S.No.10 for confirmation of renewal
status & submission of deferential fee along with complete documents/
information regarding source of pellets.
M/s. Aspin Pharma (Pvt.) Ltd, Plot No. 10 & 25, Sector 20, Korangi Industrial Area
Karachi-74900 has requested for change of registration status of following products from
M/s. OBS Pakistan (Pvt.) Ltd; Karachi to their name through contract manufacturing by
M/s. OBS Pakistan (Pvt.) Ltd; C-14, S.I.T.E, Karachi. The details are given as under:
I II III IV V
Sr. Name of Drug(s) Reg.No. Registration Remarks
No. History
1. Divestra Tablet 073476 Initial date of Reg. Dy.No.3619 (R&I )
Each tablet contains: 05-10-2012 15-04.2019
Cyproterone acetate ........2mg Change of Brand Name from Rs.70,000/-
Ethinyl estradiol…0.035mg ―Acne-Heal‖) to ―Divestra‖
(Manufacturer‘s specification) 27-05-2016 Standard formulation
approved by MHRA is
Last Renewal 15-08-2017 ―Film coated‖
with fee of Rs.10,000/-
2. U-Progest 100mg Capsule 070796 Initial date of Reg. Dy.No.3628 (R&I )
Each soft gel capsule contains: 24-08-2011 15-04.2019
Progesterone Rs.70,000/-
(Micronized)….100mg Last Renewal 22-03-2016
(Manufacturer Specifications)
3. U-Progest 200mg Capsule 073498 Initial date of Reg. Dy.No.3629 (R&I )
Each soft gel capsule contains: 27-11-2012 15-04.2019
Progesterone (Micronized)...200mg Last Renewal 28-09-2017 Rs.70,000/-
(Manufacturer Specifications) with Rs.10,000/-
i. Applications on CTD along with original fee challan for each product as mentioned in
Column-V.
ii. Copies of initial letters of registration and renewal status as stated in Column-IV above
table.
iii. Section approval (Soft Gel Capsule General & Tablet Hormone) of M/s. OBS Pakistan
(Pvt.) Ltd. Karachi verified from Licensing Division‘s letter for renewal of DML (dated
08th July, 2015).
iv. Copy of last GMP inspection report of M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 06 th
November, 2018 indicating ―Good‖ level.
v. NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 03-April-2019.
vi. Consent/NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi for Contract Manufacturing of
above mentioned products.
vii. DML of M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 31 st March, 2015.
viii. DML of M/s Aspin dated 31st May, 2015
x. Copy of Contract Agreement of M/s. OBS Pakistan (Pvt.) Ltd; Karachi and M/s Aspin.
Decision: Registration Board decided to defer the applications as requisite Form 5-F is
incomplete.
Case No.8. Request for Change in Registration Status of Products from M/s AGP Ltd,
B-23- S.I.T.E Karachi To M/s. AGP Limited, D-109 S.I.T.E., Karachi.
M/s. AGP Limited, D-109 S.I.T.E., Karachi has requested for change of
registration status of following products from M/s AGP Ltd, B-23-C S.I.T.E Karachi to their
name. Details are given as under:
Reg. Registration
S.No. Name of Drug(s) Remarks
No. History
I II III IV V
1 013583 Ceclor 50mg/ml Drops Dy.No.1447/DDC (Reg-II)
Each ml contains:- 18-08-2017
Products are
Cefaclor as Monohydarte……….50mg Rs.20,000/-
registered in the
Cefaclor 50mg/ml Suspension
name of M/s AGP approved by Health Canada,
however, cancelled post
(Pvt) Ltd, B-23-
market.
2 007176 Ceclor 125mg Suspension S.I.T.E Karachi Dy.No.1445/DDC (Reg-II)
Each 5ml contains:- 18-08-2017
on contract
Cefaclor as Monohydrate………125mg Rs.20,000/-
manufacturing
UK MHRA approved.
from M/s. AGP
3 053182 Ceclor 187mg Suspension Dy.No.1443/DDC (Reg-II)
Each 5ml contains:- Health Care (Pvt) 18-08-2017
Cefaclor as monohydrate............187mg Limited, Karachi Rs.20,000/-
& permission is USFDA approved
4 007175 Ceclor 250mg/5ml Suspension Dy.No.1449/DDC (Reg-II)
valid upto
Cefaclor as Monohydrate……. ..250mg 30.06.2020 Rs.20,000/-
USFDA approved

5 018560 Ceclor MR 375mg Tablet Dy.No.1446/DDC (Reg-II)
Each modified release tablet contains:- 18-08-2017
Cefaclor ……………… 375mg Rs.20,000/-
USFDA approved Cefaclor
375mgExtended Release
Tablet.
Standard formulation contains:
―Cefaclor as monohydrate…
375mg‖
6 017812 Ceclor MR 500mg Tablet Dy.No.12045/(R&I)
Cefacloras Rs.20,000/-
monohydarte…………500mg
USFDA approved Cefaclor
375mgExtended Release
Tablet.
7 017813 Ceclor MR 750mg Tablet Dy.No.1550/DDC (Reg-II)
Cefaclor asmonohydarte……….. 750mg Rs.20,000/-
8 007177 Ceclor 250mg Capsule Dy.No.1444/DDC (Reg-II)
Each capsule contains:- 18-08-2017
Cefaclor as Monohydarte Rs.20,000/-
…………………. 250mg
USFDA approved.
9 007178 Ceclor 500mg Capsule Dy.No.1448/DDC (Reg-II)
Each capsule contains: 18-08-2017
Cefaclor as Monohydarte……..500mg Rs.20,000/-
UK MHRA approved.
10 001071 Keflex 100mg/ml Drops Dy.No.1422/DDC (Reg-II)
Each ml contains:- 16-08-2017
Cephalexin ……… 100mg Rs.20,000/-
UK MHRA approved.
11 001070 Keflex 125mg Suspension Dy.No.1421/DDC (Reg-II)
Cephalexin ………… 125mg Rs.20,000/-
USFDA approved.
12 003757 Keflex 250mg Suspension Dy.No.1423/DDC (Reg-II)
Cephalexin……. ….. 250mg Rs.20,000/-
USFDA approved.
13 001072 Keflex 250mg Capsule Dy.No.1419/DDC (Reg-II)
Each capsule contains: 16-08-2017
Cephalexin………….250mg Rs.20,000/-
USFDA approved.
14 001073 Keflex 500mg Capsule Dy.No.1420/DDC (Reg-II)
Each capsule contains:- 16-08-2017
Cephalexin………… ….. 500mg Rs.20,000/-
USFDA approved.

i. Application with Original Fee challan for each product as mentioned in Colum V.
ii. Copies of initial letters of registration & approval letter for extension in contract
manufacturing permission as stated in column IV above.
iii. Copy of last GMP inspection of M/s AGP Limited, D-109 S.I.T.E., Karachi (DML
000044), dated 09-08-2018, indicating ―Good‖ level. Furthermore, it has been stated in

the report that the management informed that this facility is dedicated for
manufacturing of Cephalosporins only.
iv. NOC from M/s. AGP Ltd, B-23- S.I.T.E Karachi dated 19-03-2019.
v. Approval of Licensing division for Change in title from M/s AGP Healthcare (Pvt) Ltd,
D-109, S.I.T.E Karachi DML 000044 to M/s AGP Limited, D-109 S.I.T.E Karachi
000044 vide letter no. F.2-49/84-Lic (Pt) dated 29-12-2016.
vi. Approval of Licensing division for Change in title from M/s AGP (Pvt) Ltd, B-23,
S.I.T.E Karachi DML 000348 to M/s AGP Limited, B- 23 S.I.T.E Karachi 000348 vide
letter No. F.2-3/92-Lic (Vol-II) dated 29-12-2016.
vii. DML of M/s AGP Healthcare (Pvt) Ltd, D-109, S.I.T.E Karachi dated 15-07-2014.
viii. Undertakings in the light of SOPs approved vide M-283.

i. Cancellation of registration of products at S.No. 1-6 & 8-14 from the
name of M/s AGP (Pvt) Ltd, B-23- S.I.T.E Karachi.
ii. Approved registration of products at S.No. 1-6 & 8-14 in the name of
M/s. AGP Limited, D-109 S.I.T.E., Karachi.
iv. Deferred the request w.r.t products at S.No.7 for submission of evidence
of approval status of applied formulation by Reference Regulatory
Authorities.
Case No.9. Request For Change in Registration Status of Products From M/s Opal
Laboratories (Pvt) Ltd.Karachi To M/s. ScilifePhamra (Pvt.) Ltd., Karachi.
Registration Board in its 286th meeting considered the request of M/s.

ScilifePhamra (Pvt.) Ltd; 16, K.O.C.H.S, Amir Khusro Road P.O.Box # 8935 Karachi-75350
for change in registration status of following products from M/s. Opal Laboratories (Pvt.) Ltd,
LC-41, L.I.T.E, Landhi, Karachi to their name:-
S.No. Name of Drug(s) Reg.No.
1. Vpride 1mg Tablet 039350
Glimepride ……………. 1mg
The management of the firm provided Form-5 and fee of Rs. 20,000/- for each product
and provided following products:-
i. Form-5 along with fee of Rs.20,000/-each.
ii. Copy of initial letter of registration and renewal status.
iii. NOC from M/s. Opal Laboratories (Pvt.) Ltd, Karachi (dated nil).
iv. Copy of inspection report dated 10-07-2018.

M/s Opal Laboratories has submitted 3 times renewal fee on 18-10-2017 & 30-11-2017
under SRO 1005(I)/2017.
Decision of M-286: Registration Board deferred the case for confirmation of renewal status
from RRR section and submission of fresh NOC from M/s Opal
Laboratories (Pvt.) Ltd, Karachi, issued within last 6 Months.
RRR section has confirmed the renewal status i.e ―Regisatrtion Board acceded to request
of the firm and decided to grant/regularize the renewal till 11-07-2020. Furthermore, the firm has
also submitted fresh NOC from M/s Opal Laboratories (Pvt.) Ltd, Karachi dated 12-03-2019

M/s Opal Laboratories (Pvt.) Ltd, LC-41, L.I.T.E, Landhi, Karachi
ii. Approved registration of products at S.No. 1-4 in the name of M/s.
ScilifePhamra (Pvt.) Ltd; Plot No.FD-57/58-A-2 Korangi Creek
Industrial park (KCIT) Karachi.
Case No.10. Request For Change in Registration Status of Products From M/s Getz
Pharma (Pvt) Ltd. Karachi To M/s. ScilifePhamra (Pvt.) Ltd., Karachi.
M/s. ScilifePhamra (Pvt.) Ltd; Plot No.FD-57/58-A-2 Korangi Creek Industrial

park (KCIT) Karachihas requested for change in registration status of following products from
M/s Getz Pharma (Pvt) Ltd. Karachi to their name:-
S.No. Reg. No. Name of Drug and Registration
Remarks
Composition History
I II III IV V
1. 019865 M-Low 5mg Tablets Initial Reg. Date: 15-04-1997 Dy.No.2466/DDC(Reg-
Each tablet contains: II)
Amlodipine ........5mg Change of Brand name from 17-12-2018
―Amlocard‖ to ―Lopicard‖ Duplicate Dossiers
15-05-2001 14-11-2016
Rs.20,000/-
Change of Brand name from
―Lopicard‖ to ―M-Low‖
11-02-2009
Last renewal applied on

10-12-2013
2. 019866 M-Low 10mg Tablets Initial Reg. Date: 15-04-1997 Dy.No.2466/DDC(Reg-
Each tablet contains: II)
Amlodipine Change of Brand name from 17-12-2018
........10mg ―Amlocard‖ to ―Lopicard‖ Duplicate Dossiers
15-05-2001 14-11-2016
Rs.20,000/-
Change of Brand name from
―Lopicard‖ to ―M-Low‖
11-02-2009
Last renewal applied on

10-12-2013
i. Duplication Dossier with Fee Challan of Rs. 20,000/- for each product.
ii. Copies of initial letters of registration and renewal status as stated in column IV above.
iii. Section approval of M/s Scilifeverified from Panel Inspection Report for grant of DML
(dated 29-03-2016) confirming following sections;
 Sachet (General)
 Dry Suspension Oral (General)
 Ointment/ Cream (General)
iv. Copy of last GMP inspection report of M/s Scilife, Karachi dated 10-07-2018 indicating
―Good‖ level.
v. NOC from M/s. Getz (Pvt.) Ltd; Karachi dated 19th November, 2018.
W.r.t renewal status, RRR section has confirmed that the case was discussed in 288 th
Meeting of the Board and minutes are under process. As per decision recorded in minutes
(Provided by RRR Section) renewal is w.e.f 11-02-2014 to 10-02-2019. However, it is clarified
by RRR section that ―inadvertently validity of renewal has been recorded 10-02-2023 which will
be corrected as 10-02-2024. Case will be placed in forthcoming meeting of Registration Board
for the information of the Board. It is for your information that validity of renewal is according
to the change of brand name i.e., 11-02-2009. Firm applied for the renewal of year 2019 on 20-
12-2018 and accordingly the correct validity of renewal will be w.e.f 11-02-2019 to 10-2-2024.‖
M/s Getz Pharma (Pvt) Ltd. Karachi.
ii. Approved registration of products at S.No. 1-2 in the name of M/s.
Scilife Phamra (Pvt.) Ltd; Plot No.FD-57/58-A-2 Korangi Creek
Industrial park (KCIT) Karachi. For verification of duplicate fee
challan, procedure shall be adopted as approved vide 285 th meeting of
Registration Board.
Case No.11. Request for Change in Registration Status of Products From M/s Aspin
Pharma (Pvt) Ltd, Plot 10 & 25, Main Korangi Industrial Rd, Sector 20,
Korangi Industrial Area, Karachi To M/s. AGP Limited, B-23-C S.I.T.E,
Karachi
M/s. AGP Limited,B-23-C S.I.T.E, Karachi has requested for change in
registration status of following products from M/s Aspin Pharma (Pvt) Ltd, Plot 10 & 25, Main
Korangi Industrial Rd, Sector 20, Korangi Industrial Area, Karachi to their name. The details are
given as under:
Date of Registration &
S.No. Name of Drug(s) Reg.No. Remarks
Approved Pack/MRP
I II III IV V
1. Roscor 5mg Tablet 089300 21-12-2018 Dy.40(19-02-2019)
Each film coated tablet contains:- Rs. 120/10‘s Rs.20,000/-
Rosuvastatin calcium eq. to Rosuvatatin
………………….. 5mg
(As per *Innovator‘s Specification)
Each film coated tablet contains:- Rs. 200/10‘s Rs.20,000/-
……………….. 10mg
Each film coated tablet contains:- Rs. 388/10‘ Rs.20,000/-
……………….. 20mg

i. Application on Form-5 with Original Fee challan of Rs. 20,000/-.
ii. Copies of initial letter of registration as stated in column IV above.
iii. Panel Inspection Report of M/s. AGP Limited,B-23-C S.I.T.E, Karachi renewal of DML
as evidence of approved section (Tablet General) dated 28-04-2016.
iv. Copy of last GMP inspection of M/s. AGP Limited,B-23-C S.I.T.E, Karachi dated 16-10-
2018, indicating ―Good‖ level of GMP compliance.
v. NOC from M/s Aspin Pharma (Pvt) Ltd, Plot 10 & 25, Main Korangi Industrial Rd,
Sector 20, Korangi Industrial Area, Karachi dated 04-02-2019
Later on, the firm, vide letter No. RA/DRAP/070-19 dated 13-03-2019 had applied
for withdrawal from application for transfer of registration of Roscor Tablet
range. (Dy.No.166/DD(R-I) dated 20-03-2019)
Decision: Registration Board acceded to the request of M/s. AGP Limited, B-23-C
S.I.T.E, Karachifor withdrawal of their application regarding change in
registration status of above mentioned products from M/s Aspin Pharma
(Pvt) Ltd, Plot 10 & 25, Main Korangi Industrial Rd, Sector 20, Korangi
Industrial Area, Karachi to their name.
Case No.12. Request for Change in Registration Status of Products From M/s
Standpharm Pakistan (Pvt) Ltd, Lahore ToM/s. ICI Pakistan Ltd. Karachi.
M/s. ICI Pakistan Ltd., S-33, Hawkes Bay Road, Karachi has requested for
Change in Registration Status of following Products from M/s Standpharm Pakistan (Pvt) Ltd,
Lahore to their name. The details are given as under:
Registration
S.No. Name of Drug(s) Reg.No. Remarks
History
I II III IV V
1 Alcuflex Tablet 020286 Initial Reg. Date Dy.7362 R&I
Each tablet contains:- 16-10-1997 (20.02.2019)
Naproxen Sodium……550mg Change of Brand Rs.20,000/-
name
08-12-2016 The firm has now applied
for film coated tablet as
per standard formulation
approved by RRAs.

i. Application on Form-5 with Original Fee challan of Rs. 20,000/-
iii. Copy of Approval of Change of Brand Name (Alcuflex)dated 08.12.2016.

iv. Panel Inspection Report of M/s ICI Pakistan Ltd., S-33, Hawkes Bay Road, Karachi for
renewal of DML as evidence of approved section (Tablet General) dated 02-03-2018.
v. Copy of last GMP inspection of M/s ICI Pakistan Ltd., S-33, Hawkes Bay Road, Karachi,
dated 22-01-2018, indicating ―Good‖ level of GMP compliance.
vi. NOC from M/s Standpharm Pakistan (Pvt) Ltd, Lahore dated 01-02-2019.
vii. Undertakings in the light of SOP approved vide M-283 of Reg. Board.
RRR section has confirmed on 25-04-2019 that renewal application of above mentioned
product has been received within due date.
i. Cancellation of registration of Alcuflex Tablet (R# 020286) from the
name of M/s Standpharm Pakistan (Pvt) Ltd, 20-Km Ferozepur Road
Lahore.
i. Approved registration of Alcuflex Tablet in the name of M/s. ICI
Pakistan Ltd., S-33, Hawkes Bay Road, Karachi.Furthermore,
formulation shall be standardized to ―Film coated tablet‖ as per firm‘s
request &standard formulation approved by Reference Regulatory
Authorities.
ii. Reference will be sent to Cost and Pricing Division for confirmation of
Case No.13. Request for Change in Registration Status of Products From M/s Surge
Laboratories (Pvt.) Ltd., Sheikhupura To M/s. Nabiqasim Industries Pvt
Ltd. Karachi.
M/s. Nabiqasim Industries Pvt Ltd.,17/24 Korangi Industrial Area Karachi has
requested for change in registration status of following products from M/s Surge Laboratories
(Pvt.) Ltd.,10-Km Faisalabad Road BhikhiDistt.Sheikhupurato their name. The details are given
as under:
Registration
History
I II III IV V
1 065657 Prekacin Injection 500mg Initial Reg. Dy.2439(11.12.2018)
Each 2ml contains: Date Rs.20,000/-
Amikacin Sulphate eq. to 02-09-2010
Amikacin………………….500mg
Each 2ml vial contains: Date Rs.20,000/-
Each 2ml vial contains: Date Rs.20,000/-

iii. The firm has provided evidence for approval of Lyophilized/ vial (General)
Sectionissued vide Licensing Division‘s Letter No.F.2-20/85-Lic (Vol.III) (M-227)
dated20-06-2011.
iv. Copy of last GMP inspection of M/s. Nabiqasim dated 02-08-2018, indicating
―acceptable‖ level of GMP compliance& availability of ―small volume Lyophilized
Injectables‖.
v. Copy of DML of M/s. Nabiqasim dated 12-07-2014.
vi. NOC from M/s Surge Laboratories (Pvt.) Ltd dated 08-05-2019.
Decision: Registration Board deferred the request M/s. Nabiqasim Industries Pvt Ltd.
Karachifor confirmation regarding approval status of requisite
manufacturing facility i.e., Liquid vial (General) (SVP) Sectionform
Licensing Division of DRAP.
Case No.14. Request for Change in Registration Status of Products From M/s Webros
Pharmaceuticals, Rawat To M/s Bloom Pharmaceuticals (Pvt) Ltd.,Hattar.
M/s Bloom Pharmaceuticals (Pvt) Ltd., plot No. 30 Phase I & II Industrial Estate
Hattar. has requested for change in registration status of following products from M/s Webros
Pharmaceuticals, Plot No. 1 Street No. 10 National Industrial Zone Rawatto their namealong
with few changes as per details mentioned against each.
S.# Reg. No. Product for registration Registration New Remarks
with generic name History proposed
brand
name
I II III IV V VI
1. 034707 Wefen 400mg Tablet Initial Date of Blufen Dy.No.3820/R&I
Each tablet contains:- Registration 26-12-2016
Ibuprofen………..400mg 02-12-2004 Rs.20,000/-
RRR section has The case was deferred in M-267
confirmed that for clarification of renewal status.
RB acceded to The firm has also requested for
request of the following changes in the currents
firm & decided status of Registration letter:-
to grant/ i. From plain tablet to film coated
regularize the tablet
renewal till 01- ii. USP Specification
12-2019 Status of renewal needs to be
confirmed.
UK MHRA approved as Film coated

tablet.
2. 034694 Webnizole Tablet Initial Date of Zonid Duplicate Dossier with Yellow copy
Each tablet contains:- Registration of fee challan of Rs.20,000/- dated
Metronidazole……….200mg 02-12-2004 23-12-2016
The case was deferred in M-267
RRR section has for clarification of renewal status.
confirmed that The firm has also requested for
RB acceded to following changes in the currents
request of the status of Registration letter:-
firm & decided i. From plain tablet to film coated
to grant/ tablet
regularize the ii. USP Specification
renewal till 01- Status of renewal needs to be
12-2019 confirmed
UK MHRA approved as Film coated

tablet.
3. 066389 Mycelex Cream Initial Date of Blotrim Dy.No.3818/R&I
Each gm contains: Registration 26-12-2016
Clotrimazole……… 1% w/w 01-10-2010 Rs.20,000/-
RRR section has UK MHRA approved.

confirmed that
RB acceded to
request of the
firm & decided
to grant/
regularize the
renewal till 30-
09-2020
4. 066391 Acticin Cream Initial Date of Blotrix Dy.No.3817/R&I
Each tube contains: Registration 26-12-2016
Permithrin…………..5% 01-10-2010 Rs.20,000/-
w/w
(Webros Specifications) RRR section has UK MHRA approved.
confirmed that
RB acceded to
request of the
firm & decided
to grant/
regularize the
renewal till 30-
09-2020
5. 066393 Alicam Gel Initial Date of Sandan Dy.No.3815/R&I
Each gel contains: Registration 26-12-2016
Piroxicam……………0.5% 01-10-2010 Rs.20,000/-
RRR section has UK MHRA approved.
confirmed that
RB acceded to
request of the
firm & decided
to grant/
regularize the
renewal till 30-
09-2020
6. 066394 Adan Gel Initial Date of Valoron Dy.No.3816/R&I
Each gel contains: Registration 26-12-2016
Diclofenac as Diethyl 01-10-2010 Rs.20,000/-
Ammonium The firm has also requested for
Salt……………1gm RRR section has following changes in the currents
(BP Specifications) confirmed that status of Registration letter:-
RB acceded to
request of the ―Each 1g gel contains:
firm & decided Diclofenac Diethylammonium
to grant/ 11.6mg eq. to Diclofenac
regularize the Sodium….10mg.‖
renewal till 30- UK MHRA approved.
09-2020
iii. Section approval verified from Licensing Division letter No. F.3-5/93-Lic (Vol-II) dated
11-04-2016 confirming following sections.
 Tablet General
 Cream Ointment General
iv. Copy of last GMP inspection of M/s Bloom Pharmaceuticals, Hattar, dated 07-04-2018,
indicating ―Good‖ level of GMP compliance.
v. NOC from M/s Webros Pharmaceuticals, Rawatdated 30-04-2019
vi. Undertakings in the light of SOP approved vide M-283 of Reg. Board.

i. Cancellation of registration of products at S.No.1-6 from the name of
from M/s Webros Pharmaceuticals, Plot No. 1 Street No. 10 National
Industrial Zone Rawat.
ii. Approved registration of products at S.No.1-6 (along with change in
brand names)in the name of M/s. Bloom Pharmaceuticals (Pvt) Ltd., plot
No. 30 Phase I & II Industrial Estate Hattar. Furthermore,
formulations/label claims shall be standardized as per firm‘s request &
standard formulations approved by Reference Regulatory Authorities.
Case No.15. Issuance of Registration letter of Pyrexa 5mg & 10mg Tablets by M/s.
Genome Pharmaceuticals, Hattar.
Following two products of M/s. Genome Pharmaceuticals, Hattar were approved
th
in 264 meeting of Registration Board as dispersible tablets but because of availability of these
products in reference regulatory authorities in Orally Disintegrating/Orodispersible tablets the
registration letter could not be issued . Now the firm has submitted duplicate dossiers with
respect to these products with correct formulation i.e. Orodispersible tablets.
1. M/s. Pyrexa 5mg Dispersible Price 10‘s Product is available and approved
Genome Tablets Not fixed yet As Per SRO by US FDA as orally disintegrating
Pharmac Each tablet contains:- tablet, and also available and
euticals, Olanzapine …..5mg approved by MHRA as
Hattar. (Antipsychotic) orodispersible tablet specifications
Genome Specs may be given accordingly.
Name has been changed to
―Olnaz‖ due to similarity with
already registered products.
2. Pyrexa 10mg Dispersible Price has not 10‘s Product is available and approved
Tablets been fixed As Per SRO by US FDA as orally-disintegrating
Each tablet contains:- yet tablet, and also available and
Olanzapine …..10mg approved by MHRA as
(Anti psychotic) orodispersible tablet specifications
Manufacturer‘s Specs may be given accordingly.
Name has been changed to

―Olnaz‖ due to similarity with
already registered products.
Decision of M-287: Registration Board decided to defer the case for submission of fresh fee
for both products.
Now the firm has submitted a fresh fees of Rs.20,000/- for each product dated 6.02.2019.
(Deposit Slip # 084063 & 084062 respectively).
Decision: Registration Board deferred the request of M/s. Genome Pharmaceuticals,
Hattarfor submission of generic/me-too status of Olanzapine orally-
disintegrating/ Orodispersible Tablet 5 mg & 10mg.

Case No.16. Correction in Letter of Drug(s) of M/s. Helix Pharma (Pvt.) Ltd; Karachi
M/s. Helix Pharma (Pvt.) Ltd; Karachi has requested for correction in formation of their
following registered product:-
S.No. Name of Drug(s) with existing Existing MRP & Correct MRP & Reg.No.
formulation Pack Size Pack Size
1. Vomitron 3mg / 3ml Injection Rs. 253.00 / 3ml Rs. 253.00 / 3ml 086056
Each 3ml contains:- vial ampoule
Granisetron as hydrochloride
……….. 3mg
The firm has requested to correct the pack from vial to ampoule as the firm has approved
ampoule section by Licensing Division and they had also applied the drug in ampoule dosage
form.
It is submitted that product was approved in 274 th meeting of Registration Board as under:-
1 Name and address of manufacturer / M/s Helix Pharma (Pvt.) Ltd., Hakimsons House, A-56,
Applicant S.I.T.E., Karachi.
Brand Name +Dosage Form + Strength Vomitron 3mg/3ml injection
Granisetron as hydrochloride……….3mg
Pharmacological Group 5HT3-antagonist
Type of Form Form-5
Pack size & Demanded Price 3ml x 1‘s; As per PRC
Approval status of product in Granisetron 1mg/ml concentrate for solution for
Reference Regulatory Authorities injection or infusion (MHRA approved)
Me-too status (with strength and Graniset 3mg/3ml injection of M/s CCL
dosage form)
GMP status Last inspection conducted on 10-08-2017 and report
concludes that firm is operating at satisfactory level of
compliance with GMP.
Decision:Approved.
The above contents of the Registration Board shows that the firm has not specifically for
ampoule, therefore, letter was issued with vial dosage form. There is a considerable difference
between the price of vial and ampoule pack sizes for above product.
Decision of M-279: Registration Board deferred the case for clarification from Costing and
Pricing Division on the price of the above mentioned product in vial and
ampoule.
The pricing division has clarified vide letter .No.F.11-20/20148-DD(P) (M-279 Local) dated 17-
01-2019. That price of Granisetron 3mg ampoule has been fixed vide SRO 252 (I)/2018 dated
21-02-2018. Division of PE&R may proceed if it is same drug.
MRP Fixed vide said SRO 252 (I)/2018 dated 21- MRP/ Pack issued vide Reg. Letter No. F. 3-
02-2018 11/2017 Reg-II (M-274) dated 18-12-2017
Rs.3165/5x3ml Rs.253/3ml Vial
Rs.633/1x3ml
Decision: Registration Board deferred the case for seeking opinion of Costing &Pricing
Division of DRAP.

Case No.17. Products of M/s S.J & G. FazulEllahie (Pvt) Ltd., E/46, SITE, Karachi
Registration Board in 215th meeting approved following products of M/s S.J & G.
FazulEllahie (Pvt) Ltd., E/46, SITE, and Karachi. Case was again discussed in 259 th meeting
wherein board deferred the following product due to reasons mentioned in last column below:
Product name with specification Demanded Decision
pack size
Vivid Suspension 60ml Registration Board deferred the case
Each 5ml contains: for confirmation of me too status.
Voriconazole ……….200mg
The firm has provided evidence of fee of Rs. 15,000/- dated 29th December, 2008 and Rs.
35,000/-on 24th September, 2013 and Form-5D. However, the fee challans are not original nor
endorsed by STO DRAP.
Decision of M-267: Registration Board deferred the request of the firm for verification of fee
challans from Budget and Accounts.
The firm has now provided yellow copy of deposit slip of Rs.35,000/- & photocopy of
deposit slip of Rs.15,000/- along with letter of verification issued by ―Federal Treasury‖.
However, different account heads are mentioned on challan copy& verification letter.
Decision: Registration Board observed that the case pertains to verification of
duplicate fee challan that has already been addressed vide its 285 th meeting.
Case No.18. Correction in Price of Drug(s) of M/s. Barrett Hodgson Pakistan (Pvt.) Ltd,
Karachi.
M/s. Barrett Hodgson Pakistan (Pvt) Ltd; F/423, SITE Karachi-75700 has
requested that they were granted the registration of following product with MRP Rs.770.00/20‘s
while the price is fixed as under:-
S.# Regn Product(s) with composition. MRP/Pack Issued Approved MRP/Pack
No. on Reg. Letter as per Pricing
Minutes
1. 091005 Vesibar Tablet 5mg Rs. 770.00 /20‘s Rs. 779.00/20‘s
Each tablet contains:- 9th PAC
Solifenacin succinate……….5mg
equivalent to 3.8mg Solifenacin
The firm has requested to grant them the correct price and remaining pack size & MRP. Extract
from the minutes of 282th meeting of Registration Board is as under:-
5. Name and Address of Manufacturer / M/s Barrett Hodgson Pakistan (Pvt) Ltd.
Applicant F/423 S.I.T.E.Karachi.
Brand Name+ Dosage Form+Strength Vesibar Tablet 5mg
Diary No. Date of R & I & fee Diary No:3652, 23/05/2017, Rs: 20,000/-
Solifenacin succinate…5mg equivalent to 3.8mg Solifenacin.
Type of Form Form 5
Pack Size & Demanded Price 10‘s/ Rs.550/- 14‘s/ Rs.770/-
20‘s/ Rs.1100/- 28‘s/ Rs.1540/-
30‘s/ Rs.1650/-

Approval Status of Product in Reference Solifenacin 5 mg film-coated tablets by M/s Milpharm
Me-too Status Solina 5mg Tablet by M/s Hilton Pharma (Reg#61212)
GMP Status Last Inspection conducted on 08-08-2017and report concludes
that overall GMP compliance of the firm was found quite
satisfactory.
The firm has further requested to approve the price for film coated tablet and also approve the
description of the product.
Decision of 19th PRVC: The Committee evaluated and recommended the case in light of
SOP‟s approved by Registration Board. The request of the firm for
correction in pharmaceutical form i.e. film coated tablet has been
approved by the Chairman Registration Board while for correction
of MRP, the case has been referred to Registration Board.
Decision: Registration Board approved the correction in MRP of Vesibar Tablet 5mg
(R#091005) from Rs. 770.00 /20‘s to Rs. 779.00/20‘s.
Case No.19. Correction in Registration letter of M/s. Atco, Labs, Karachi.

M/s Atco Laboratories Limited, B-18, S.I.T.E, Karachi-75700 have applied for
correction of strength of their following registered products:
S.No Reg.No Name of Drug(s) with Name of Drug(s) with Remarks
existing Composition existing Composition
I II III IV V
1 088221 Atcovate 0.05% Lotion Atcovate 0.05% Lotion The Registration Board
Each gm contains:- Each gm contains:- approved the existing
Fluticasone Propionate Fluticasone Propionate formulation as mentioned in
……. 0.05mg ……. 0.5mg column No. III. However,
(USP Specification) (0.05% w/v) correction is required in
(USP Specification) strength of Fluticasone
Propionate from
―0.05mg‖ to ―0.5mg‖ andper
unit claim from
―Each gm contains:‖ to
―Each ml contains:‖
The management of the firm has provided following documents for this purpose:-
i. Original challan of Rs. 5000/-.
ii. Copies of initial letter of registration.
iii. Registration is valid.
Decision of M-283: Registration Board deferred the case for confirmation of MRP fixed for
“Fluticasone Propionate0.5mg/ml Lotion”.
Pricing Division has fixed the MRP of Rs.200/20ml vide 12 th DPC and same has been
granted to above mentioned formulation vide letter No. F. 3-13/2017 Reg-II (M-276).
Decision: Registration Board approved the correction in composition of Atcovate
0.05% Lotion (R# 088221) i.e., as under:
Atcovate 0.05% Lotion
Each gm contains:-
Fluticasone Propionate ……. 0.5mg (0.05% w/w)
(USP Specification)
Case No.20. De-Registration of Alpram Tablet of M/s. Akhai Pharmaceuticals (Pvt.) Ltd.
Karachi.
M/s. Akhai Pharmaceuticals (Pvt.) Ltd; A-248, A-256 to A-259, H.I.T.E,
Lasbella, Balochistan has requested they were granted the registration of following product in
import and later the product was transferred from import to local contract manufacturing by M/s.
Cirin Pharmaceutical (Pvt.) Ltd; for a period of 10 months (from 18-12-2006 to 17-10-2007)
vide letter dated 18-12-2006:-
S.No. Name of Drug(s) Reg.No.
1. Alpram Tablet 015749
Alprazolam ……………. 0.5mg
Later on, contract manufacturing permission was extended till 27-05-2008 vide letter
dated 28-11-2008 by M/s. Cirin Pharmaceuticals, Hattar. Subsequently the permission was
extended through same manufacturer till 08-07-2009 and 30-06-2010 vide letters dated 24-07-
2008 & 13-07-2009.
The firm had applied for renewal of registration of above drug on 13-12-2011 with fee of
Rs. 4000/- and on 18-08-2016 with fee of Rs. 10,000/-. The case of the firm was forwarded to
RRR section for confirmation of renewal status and RRRl section has forwarded the case with
the remarks that the above product was registered under contract manufacturing from M/s. Cirin
Pharmaceuticals (Pvt.) Ltd; Hattar and forwarded the case to Reg-II Section for processing.
In the meanwhile, the firm has submitted approval of Tablet (Psychotropic) Section by
Licensing Division and requested to transfer the registration of above product in the name of
their firm as they have developed their own facility. Furthermore, the firm has also provided a
copy of application with fee of Rs. 20,000/- wherein the firm had applied for contract to local
manufacturing on their own facility.
The case was deferred in 4th PRVC meeting for further deliberation in its next meeting.
Decision of M-279: Registration Board deferred the case for opinion of Legal Affairs Division.
The firm has now applied for de-registration of Alpram 0.5mg Tablet (R#015749) stating
that they have been granted new registration of same molecule under Reg. No.089351 vide 280th
meeting held on 15-03-2018.
Decision: Registration Board acceded to the request of M/s. Akhai Pharmaceuticals
(Pvt.) Ltd; A-248, A-256 to A-259, H.I.T.E, Lasbella, Balochistan for de-
registration of Alpram Tablet 0.5mg (R# 015749).
Case No.21. Request of M/s Delta Pharma, Risalpur for Extension in Contract
Manufacturing Permission Along With Change in Contract Manufacturer.
M/s Delta Pharma, Risalpur has submitted 3 times renewal fee on 04-12-2017 in
pursuance of SRO 1005(I)/ 2017 dated 05-10-2017 for renewal/ extension in contract
manufacturing permission along with change in contract manufacturer of following products:
S.No Reg.No Name of Product Previous New Date of
Manufacturer Manufacturer applications/Fee
1. 050327 G-Xon 500mg Injection M/s. Medicraft M/s Bio-Lab 04-12-2017

Each vial contains: Pharmaceutical (Pvt) Ltd., Rs.150,000/-
Ceftriaxone (as s, Peshawar Islamabad
Sodium)….500mg
(USP Specification)

2. 044259 G-Xon 250mg Injection -do- -do- -do-
Each vial contains:
Ceftriaxone (as
Sodium)….250mg
(USP Specification)
3. 044260 G-Xon 1gm Injection -do- -do- -do-
Each vial contains:
Ceftriaxone (as Sodium)….1gm
(USP Specification)
With reference to above mentioned case following facts are submitted:

i. The 3 times renewal fee in respect of above products was submitted even after
expiry of deadline i.e 03-12-2017 set under the SRO 1005(I)/ 2017.
ii. The 3 times renewal fee has been submitted on 4-12-2017 while the DML status
was invalid. However the firm was granted DLM (Afresh) on 18-12-2017 with
Tablet (General) & Capsule (General) sections.
The Board was informed that the fee has been submitted under the head of contract
manufacturing. However the firm, in its request has stated that the fee is submitted with
reference to SRO 1005(I)/ 2017.
Decision of M-281: - Registration Board observed that though the fee is submitted under SRO
1005(I)/ 2017 which address the issue of renewal of registration while this
case falls in the category of extension of contract manufacturing.
However, since the fee is submitted during the period when the DML of
the firm was invalid so the case was deferred for soliciting the views/
comments of Legal Affairs Division of DRAP regarding validity of the fee
submitted by the firm.
Accordingly, the case was referred to Legal Affair Divisions and the said division has
responded as under:
―The DML of firm is not valid on the date of submission of fee. The DML was granted
afresh to the firm on 18-12-2017 while the fee was submitted by the firm on 04-12-2017.
Further, the firm deposited the fee under SRO 1005 (I)/2017 under the head of contract
manufacturing therefore, the application of the firm for extension in contract
manufacturing cannot be entertained against the fee submitted under SRO 1005 (I)/2017.
It is gain clarified that the SRO 1005(I)/2017 only covers the renewal of regular
registered products and not the extension of contract manufacturing.‖
Decision: Registration Board deliberated the case in the light of comments submitted
by Legal Affairs Division of DRAP and decided that the above mentioned
request of M/s Delta Pharma, Risalpur shall not be acceded as the DML of
the firm was not valid on the date of submission of fee.
Case No.22. Brand Name Resemblance of Approved Products of M/s Caliph

Pharmaceuticals, Risalpur.
Registration Board, in its 279th meeting approved the following two products of
M/s Calpih Pharmaceuticals, Risalpur. Detail is given as under:
Name and address of manufacturer / Caliph Pharmaceuticals Pvt. LTD, Plot 17, Special Industrial
Applicant Zone Risalpur, KPK
Brand Name +Dosage Form +Strength Largyl Tablet 200mg
Metronidazole…….200mg
Pharmacological Group Antiamoebic
Type of Form Form 5
Pack size & Demanded Price 10x10‗s; As per SRO
Approval status of product in Flagyl 200 mg Approved by (MHRA)
Me-too status Flagyl of Sanofi Aventus
GMP status Last GMP inspection Date:07-03-2017 with satisfactory cGMP
compliance
Decision: Approved
Name and address of Caliph Pharmaceuticals Pvt. LTD, Plot 17, Special Industrial
manufacturer / Applicant Zone Risalpur, KPK
Brand Name +Dosage Form +Strength Largyl Tablet 400mg
Metronidazole…….400mg
Pharmacological Group Antiamoebic
Type of Form Form 5
Pack size & Demanded Price 10x10‗s; As per SRO
Approval status of product in Flagyl 400 mg Approved by (MHRA)
Reference RegulatoryAuthorities.
Me-too status Flagyl of Sanofi Aventus
GMP status Last GMP inspection Date:07-03-2017 with satisfactory cGMP
compliance
Decision: Approved
While processing for issuance of registration letter, it was identified that the applied
brand name ―Largyl‖ resembles with ―Flagyl‖ &M/s. Caliph Pharma was advised accordingly to
change brand name of their product ―Largyl‖. The firm responded by producing evidence that
same brand name has already been granted to their registered product i.e. ―Largyl 200mg Liquid
Suspension‖ bearing registration no.079356‖. The firm has also produced evidence of similar
name with little variance to different firms. For example Metrogyl (Unexo lab, Reg #009498),
Ferogyl (Fedro Pharma, Reg #011926), Entagyl (BJ Pharma, Reg#087946) and Resgyl (Rasco
Pharma, Reg#078931).
It was later on identified that the registered brand name of M/s Caliph is ―Fedragyl‖
instead of ―Ferogyl‖
Decision: Registration Board deliberated the case regarding resemblance of brand
names and observed that unlike ―Largyl‖, the brand names ―Metrogyl‖,
―Fedragyl‖, ―Entagyl‖ and ―Resgyl‖ do not closely resemble with ―Flagyl‖.
Therefore, M/s Caliph Pharmaceuticals Pvt. Ltd, Plot 17, Special Industrial
Zone Risalpur, KPK shall be directed to change the brand name of their
registered product ―Largyl 200mg Liquid Suspension (Reg # 079356)‖.

Case No.23. Approved Cases of Revision of Formulation
Registration Board, in its various meetings approved following cases of revision
of formulation in the light of decision taken by the Board, vide its 250 th meeting.
a) Revision of Formulation of Nocer 10 Suspension (Reg. No. 042966)

M/s. Bryon Pharmaceuticals, Peshawar has requested for revision of formulation of
their registered product Nocer 10 suspension in the light of decision of M-250 that is reproduced
below:
90. FAMOTIDINE 10 MG/5ML LIQUID SUSPENSION
International availability Me too status Remarks
Not available in reference ACICON of M/s Barret Not approved by reference drug
authorities Hodgson, Karachi regulatory agencies. Internationally
CAPSID of M/s Olive Labs, available formulation is dry powder for
Islamabad suspension in the strength of 40 mg/ 5
ml. (Ref: US FDA)
Decision:
i. Applicants shall revise their formulation as per innovator (new registration application with complete fee)
within six months if manufacturing facility is approved by CLB.
ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be adopted. Otherwise
show cause notice shall be issued for de-registration of registered drugs in this formulation.
iii. All such application shall be processed on priority basis.
The firm has submitted a fresh dossier with revised formulation as per following details:
Reg. No. Previous formulation Revised formulation
042966 Nocer 10 suspension Nocer 40 Dry Suspension
Each 5ml contains: Each 5ml contains:
Famotidine……..10mg Famotidine……..40mg
Detail of submissions:
i) Application on form-5 with fee of Rs.20,000/-
ii) Copy of Registration letter dated 13-04-2006
iii) Last renewal submitted on 31-03-2016 (verified from copies of submissions to the
renewal section)
iv) Last inspection report dated 15-02-2017
v) Data regarding Accelerated stability study conducted on 3 batches (from Oct-2016-
Apr-2017).
Decision of M-276: The Registration Board approved the revision of formulation & also
modification of the brand name accordingly in line with decision of its
250th meeting as per following details:
Nocer 40 Dry Suspension: Famotidine 40mg/5ml
Accordingly, fresh registration letter was issued to M/s. Bryon Pharmaceuticals,
Peshawar for Nocer 40 Dry Suspension (R#087998).
b) Revision of Formulation of Zithrox Capsule (Reg. No. 052518)
M/s. MKB Pharmaceuticals, Peshawar has requested for revision of formulation of their
registered product Zithrox Capsule in the light of decision of M-250 that is reproduced below:
12. AZITHROMYCIN 500MG CAPSULES
International availability Me too status Remarks
Not approved in reference drug AZOGEN of M/s Not approved in reference drug agencies.
agencies. Only 250 mg capsules are Rogen, Islamabad. Only 250 mg capsules are approved.
approved. However, 500 mg tablets AZOTINE of M/s However, 500 mg tablets are available.
are available. Nimral Pharma, When azithromycin capsules were
Zithromax of M/s Pfizer, UK. Islamabad administered with food, the rate of
absorption (Cmax) of azithromycin was
reduced by 52% and the extent of
absorption (AUC) by 43%.
Zithromax 250 mg capsules should be given
as a single daily dose. In common with
many other antibiotics Zithromax Capsules
should be taken at least 1 hour before or 2
hours after food. (Ref: MHRA)
Decision:
i. Applicants shall either revise their formulation to tablet dosage form, if not registered previously and if
manufacturing facility is approved by CLB (new registration application with complete fee) or,
ii. Shall submit Pharmaceutical development data including stability, bioavailability/ bioequivalence studies
within six months period.
iii. For already registered drugs, same procedure as mentioned above (at Sr. No. i& ii) shall be adopted.
Otherwise show cause notice shall be issued for deregistration of drug in this formulation.
iv. All such application shall be processed on priority basis.
The firm has submitted a fresh dossier with revised formulation as per following details:
Reg. No. Previous formulation Revised formulation
052518 Zithrox Capsules Zithrox Tablet
Each capsule contains: Each film coated tablet contains:
Azithromycin as dihydrate……..500mg Azithromycin as dihydrate……..500mg
Detail of submissions:
i) Application on form-5 with fee of Rs.20,000/-
ii) Copy of Registration letter dated 18-09-2008
iii) Last renewal submitted on 09-09-2013 (verified from copies of submissions to the
renewal section)
iv) Last inspection report dated 26-12-2016
v) Data regarding stability study i.e 6 months accelerated &12 months real time
conducted on 3 batches (from Mar-2016- Mar-2017).
Decision of M-276: The Registration Board approved the revision of formulation of Zithrox
Capsules to Zithrox Tablets containing "Azithromycin as
dihydrate…..500mg" in line with its decision of 250 th meeting.
Accordingly, fresh registration letter was issued to M/s. MKB Pharmaceuticals, Peshawar
for Zithrox Tablets (R#087999).
c) Revision of Formulation of Registered Product(s) of M/s. Akhai Pharmaceuticals

(Pvt.) Karachi.
M/s. Akhai Pharmaceuticals (Pvt.) Ltd; A-248, A-256 to A-259, H.I.T.E,
Lasbella, Balochistan has requested for revision of formulation of their following registered
product:-
S.No. Name of Drug(s) with existing Name of Drug(s) with demanded Reg.No.
formulation formulation
1. Zonacin 500mg Capsule Zonacin 500mg Tablet 070429
Each capsule contains:- Each film coated tablet contains:- dated 21-04-
Azithromycin ………… 500mg Azithromycin ………… 500mg 2011
(BP Specification) (USP Specification)

The firm has stated that after reviewing the effectiveness and dosage of capsule against
the tablet formulation which contains same molecule, they believe that their formulation should
be changed to tablet. The firm has stated that Azithromycin is not available in BP specification
and it is available in USP specification. They have requested to correct the specification from BP
specification to USP specification. The firm initially provided fee of Rs. 5000/- only along with
Form -5 for above product.
The PRVC in its 4th PRVC deferred the case to provide fee of Rs. 20,000/- and Form-5
and evaluation of the case in light of 250 th meeting decision of Registration Board. The
management of the firm has provided relevant information along with balance fee of Rs. 15,000/ -
. The RRR section has informed that the renewal application of the above product received
within time.
Decision of M-283: Registration Board approved the revision of formulation of Zonacin
500mg Capsules to Zonacin 500mg Tablets with USP Specifications.
Registration/approval letter for revised formulation of Zonacin tablet has not been issued yet.
In view of the position explained above, casesmentioned at a) and b) have been placed
for deliberation regarding registration status of previously registered formulations of these
products as fresh registration letters with new registration numbers have been issued for revised
formulations. Furthermore, w.r.t the third case(c)& all such cases in future,guidance is sought for
issuance of fresh registration letter or post-registration approval letter for revision of formulation.
Decision: Registration Board observed that since the above mentioned formulations
have been revised to new dosage forms. Therefore, it will be more
appropriate to issue fresh registration certificates. Accordingly, the Board
also directed to cancel the previously registered formulations as per following
details:
i. Cancellation of registration of Nocer 10 suspension (R# 042966) from the
name of M/s. Bryon Pharmaceuticals, Peshawar.
ii. Cancellation of registration of Zithrox Capsules (R# 052518) from the name
of M/s. MKB Pharmaceuticals, Peshawar.
iii. Cancellation of registration of Zonacin 500mg Capsule (R# 070429) from the
name of M/s. Akhai Pharmaceuticals (Pvt.) Ltd; A-248, A-256 to A-259,
H.I.T.E, Lasbella, Balochistan.
Case No.24. Request of M/s Abbott Laboratories (Pakistan ) Limited for Correction in
Composition of Citrosoda Regular.
Registration Board, in its 284th meeting, held on 31st July- 01st Aug, 2018
considered the request of M/s Abbott Laboratories (Pakistan) Ltd Opp. Radio Pakistan
Transmission Centre, Hyderabad Road, Landhi, Karachi for Change in flavor of Citrosoda
(008749) i.e reproduced as under:
M/s. Abbott Laboratories (Pakistan) Ltd Opp. Radio Pakistan Transmission Centre,
Hyderabad Road, Landhi, Karachi-75120 has requested that they have the registration of
following product with lemon flavor. The management of the firm has submitted application on
registration dossier and fee of Rs. 20,000/- and has requested to grant them additional variant
without any flavor:-

S.No. Reg.No. Name of Drug(s) Demanded MRP and specs International
availability
1. 008749 Citrosoda 100‘s TGA
Each sachet 4gm contains:- 20‘s Australia
Sodium Bicarbonate….1.76gm 100‘s Ural Sachet
Sodium Citrate ………0.63gm 20‘s
Citric Acid ………….. 0.72gm (The firm has stated that
Tartaric Acid ……….. 0.89gm Citricosoda is already a
registered brand of Abbott in
flavors of Orange and lemon
(Originator Brand)
Decision of M-284: Registration Board approved the registration of above product with
innovator specifications. The claim of firm regarding MRP of the product
shall be referred to Cost & Pricing Division.
The firm has informed that the formulation of Citrosoda Regular mentioned in 284 thmeeting is
not correct as per the documents & approval submitted by the firm with application & form-5,
dated 02-05-2018 & 18-07-2018. Now the firm has requested to correct the formulation as
mentioned below.
S/ Reg.# Composition Correct composition/ Correct composition/ Packsize
N Approved in M-284 gramof Sachet 4gram of Sachet
I II III IV V VI
1. 008749 Citrosoda CitrosodaRegular CitrosodaRegular 4gm Sachet
Each sachet 4gm Each gm of sachet Each 4gm of sachet of 20‘s
contains:- contains:- contains:- 4gm sachet
Sodium Sodium Sodium Bicarbonate of 100‘s
Bicarbonate...1.76gm Bicarbonate...0.429gm …………….1.716gm
Sodium Sodium Sodium
Citrate………0.63gm Citrate……..0.153gm Citrate……....0.613gm
Citric Citric Citric
Acid..…….....0.72gm Acid……....0.176gm Acid…........0..702gm
Tartaric Tartaric Tartaric
Acid..............0.89gm Acid............0.215gm Acid………0.858gm
Decision: Registration Board approved the correction in composition of Citrosoda

Regular i.e., as under:
Citrosoda Regular
Each gm of sachet contains:-
Sodium Bicarbonate......0.429gm
Sodium Citrate………...0.153gm
Citric Acid…………….0.176gm
Tartaric Acid.................0.215gm

Case No.25. Request of M/s Safe Pharmaceuticals (Pvt) Limited, Karachi for Correction
in Formulation of Fayneec Capsule 50mg
M/s Safe Pharmaceuticals, Karachi was granted approval for registration of Fayneec
50mg Capsule vide 260thmeeting of Registration Board as per below mentioned detail.
S/N Name and Brand Name Type of Form Remarks on the Remarks Decision of
address of (Proprietary name + Dosage Initial date, formulation (if by M-260
manufacturer / Form + Strength) diary any) including Evaluator/
Applicant Composition Fee including International Decision
Pharmacological Group differential status in
Finished product fee stringent drug
Specification Demanded regulatory
Price / Pack agencies /
size authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by
the Evaluator
1. M/s Safe Fayneec Capsule 50mg Form 5 Deflamat 50mg- Fee Approved.
Pharmaceuticals Dy No. Nil Kapseln by M/s Rs.8000 & Photocopy
Pvt Ltd, Each capsule contains:- dated 17-02- Astellas Pharma Rs.12,000/- fee
Karachi Diclofenac Sodium as SR 2010 GmbH Austria. are challanswill
pellets………..………50mg Rs.8000 Local. Mobikare photocopy. be verified
Source of (Photocopy) 50mg by M/s by Budget
Pellets Anti-Rheumatics & 22-05- Barrett Hodgson & Accounts
M/s Vision 2013 GMP compliant Division
Pharmaceuticals USP Specifications Rs.12000 as per and
Kahuta road, (Photocopy) inspection Chairman
Islamabad As per SRO report dated 09- Registration
06-2015. Board will
15 permit
issuance of
registration
letter.
Later on, after verification of duplicate fee challans, registration letter couldn‘t be issued
as the approval status of Diclofenac Sodium 50mg SR Capsule couldn‘t be confirmed in
Reference Regulatory Authorities.However, the firm has now informed that the formulation of
Fayneec Capsule 50mg mentioned in 260 thmeeting is not correct as per documents submitted by
the firm at the time of initial application. Detail is given below:
S/N Composition Approved in M-260 Correct Composition as per Firm‘s
Request
I II III
1. Fayneec Capsule 50mg Fayneec Capsule 50mg
Each capsule contains:- Each capsule contains:-
Diclofenac Sodium as SR Diclofenac Sodium………..………50mg
pellets………..………50mg
In this regard, the firm has submitted photocopies of following documents stating
―Fayneec Capsule 50mg (Diclofenac Sodium)‖:
i. Form-5 along with fee deposit slips…..whether enteric coated granules/pellets
mentioned anywhere

ii. MOH acknowledged receipt for Fee of Rs.8000/-
iii. DRAP‘s acknowledged receipt for Fee of Rs.12,000/-
iv. Last Inspection Report dated 31-07-2018 (Compliance level: GOOD)
Decision: Registration Board approved the correction in formulation of Fayneec
Capsule 50mg as per details mentioned vide column III of above table. The
Board further directed the firm to submit an undertaking stating their
Case No.26. Request of M/s. Zaynoon Pharmaceuticals, Peshawar For Grant of Afresh
Registration.
The Registration Board, in 276th meeting held on 22 nd - 25thNovember, 2017,
declared registration of all drugs of M/s. Zaynoon Pharmaceuticals, Peshawar invalid due to
invalidity of DML declared by CLB (vide 249th meeting). However, the firm was issued afresh
DML No. 000358 by way of formulation, dated 11-04-2017. Management of the firm has
now applied for registration of following products on form-5 with fee of Rs.20,000/- each as per
details mentioned below:
S.No. Brand Name, Dy.No./Date Evidence of Section Approval,
Composition and & Availability in Last
(Reg.No) Demanded RRAs and Inspection Report &
Price/ Pack Metoo Status DML
Provided by
Firm
1. Zayfen Suspension. Rs.14.00 Bruphene Approval of Liquid
Each 5ml contains:- Rs.18.00 Suspension of Syrup
Ibuprofen……………….100mg 60ml M/s. Abbott Section: 13-04-2017
(B.P Specification) 90ml Karachi Last Inspection
Reg. No.064409 report: 11-01-2018
DML: 11-04-2017
(Flag- A)
2. Nafpol 6 Plus Suspension. Rs.15.00 Calpol 6 Plus -do-
Each 5ml contains:- 60ml Suspension
Paracetamol……………250mg. M/s. GSK
(BP Specification)
Reg. No.064410
3. Zaycid Suspension. Rs.18.00 Mylanta -do-
Each 5ml contains:- 120ml Antacid
Aluminium Hydroxide….....215mg. Original Oral
Magnesium Hydroxide……….80mg. Liquid Bottle
Simethicone…………………..25mg. of M/s.
(USP Specification) Johnson &
Reg. No.064411 Johnson
Karachi
The firm has provided copies of challan of Rs.20,000/- for each product. They have requested to
re-register the above products accordingly.
As per information obtain from QA&LT Division, based on critical observation made by FID
querying routine GMP inspection on 11-10-2018, a panel has been constituted for thorough
inspection of the firm for verification of observation.
S.No. Observations
1. The air curtain was not working at the male change room entrance.
2. The management has placed a basin in the change room which is advised to be removed.
3. Raw material store is very small and the passage to liquid section is also from the
receiving area for materials; which needs to be separated by some partition.
4. The firm is also advised to provide the quarantine for the received materials.
5. The raw material testing record was seen randomly but regretted to state the record was
not up-to-date although QC released tags found placed on all the raw material but the
data is not traceable in the QC lab.
6. Improvement is advised in the condition of the dispensing room.
7. The management is advised to change the balance in the dispensing room.
8. The management is advised to control the humidity before dispensing the Raw Material.
9. The flooring in the liquid section is in very bad condition and needs immediate
improvement; especially the washing area needs replacement of tiles.
10. The management is using used bottles which should be immediately stopped as already
advised in the last inspection.
11. In the QC Lab the record is not maintained and loose papers are being used for the
recording of the test results; the management is directed to use ledgers for the data so it
can be kept in safe custody.
12. HPLC is not in working condition, it is a very old model and needs to be replaced.
13. The management is also advised to follow official testing methods for the testing of their
registered products and should buy recent official books which are mandatory for the
development of their QC methods.
14. The SOP for stability testing are not satisfactory.
15. The capacity of the Stability Chamber was also not sufficient for their registered
products.
16. The HPLC operator also needs training.
17. The management is advised to appoint the full time QA in-Charge with sufficient
experience.
18. The management is advised to immediately do the following;
a) Calibration of all the equipment.
b) Preparation and up-gradation of all the SOPs of Production and QC
c) Purchase of official books (latest edition) and preparation of testing method
accordingly.
d) Up-gradation of HPLC.
e) Adaptation of official testing method.
f) Training of staff.
g) Appointment of QA staff as per rules.
Decision of M-286: Registration Board deferred the above-referred case till the firm complies
with GMP requirements.
The firm has now provided the latest GMP Panel Inspection Report dated 12-12-2018, conducted
for the verification of the compliance/ improvements of the firm with reference to last inspection
dated 11-01-2018.
Conclusion:
The firm‘s management has rectified most of the observations of previous inspection. They have
purchased Karl Fischer apparatus and also submit the invoice of FTIR and it will be delivered to
them in two months time. In light of above mentioned observations it is concluded that the firm
is now operating at ―Good‖ level of GMP Compliance.

Decision: Registration Board decided as under:
i. Approved the grant of registration for products at S.No. 1 & 2 of above table.
ii. Deferred the product at S.No.3 for submission of evidence confirming approval
status of applied formulation in Reference Regulatory Authorities.
Case No.27. Registration of Co-Dep 12/25 Capsule of M/s. Nabiqasim Industries Private
Limited, Karachi.
Registration Board, in its 237th meeting considered the following product of M/s
Nabiqasim Industries Private Limited, Karachi as per below mentioned details:
Sr. No Name of Name of drug(s) & Proposed Demanded Date of application, Remarks
firm(s) Composition Pack size Price Diary No. & Form
1. M/s Co-Dep 12/25 Capsule 10‘s As per PRC 18-11-2011
NabiQasim Each capsule contains: 14‘s Dy.No.372
Karachi Olanzapine ………12 mg 20‘s Form-5
Fluoxetine HCl…..25 mg 30‘s Rs.8000/-
(Anti psychotropic) Rs.52,000/-
24-1-2013
Decision of M-237: The board referred the cases to committee comprising of Brig.(R).Prof.
Dr. Muzammil Hasan Najmi (Member Registration Board), Dr.
TaufeequrRehman, Assistant Professor, Department of Pharmacy, Quaid-
e-Azam University, Islamabad (Member Registration Board), DDG (Reg-
II) and concerned DDC for securitization, verification of codal
requirements and recommendations for me-too registration applications.
The recommendations of committee will be submitted to Chairman,
Registration Board for decision.
Minutes of Expert Committee of Drug Registration Board
Name of Name of drug(s) & Composition Proposed Demanded Date of Remarks

firm(s) Pack size Price application,
Diary No. &
Form
M/s Co-Dep 12/25 Capsule 10‘s As per PRC 18-11-2011 Deferred for
NabiQasi Each capsule contains: 14‘s Dy.No.372 confirmation
m Karachi Olanzapine ……….……12 mg 20‘s Form-5 of me-too
Fluoxetine HCl….……..25 mg 30‘s Rs.8000/- status
(Anti psychotropic) Rs.52,000/-
24-1-2013
The firm has now referred to 248 th meeting of Registration Board, wherein, it has been
stated that a number of formulations including above mentioned formulation will be considered
for registration by Registration Board and thus the Board advised P E & R Division to place all
deferred cases in agenda of the meeting. However, their deferred application has not been put on
agenda.
In this regard, the firm has provided the following documents& requested for grant of
registration:
i. Photocopy of Acknowledgement Receipt of Registration Application dated 16-11-2011.
ii. Photocopies of fee deposit slips of Rs.8,000/- & Rs.52,000/-.
iii. Evidence for approval status of applied formulation in USFDA (As mentioned in below
table)
Company Drug Name Active ingredient Strength Dosage Form/Route
Lilly Symbyax Fluoxetine HCL ; EQ 25mg Base Capsule :Oral
Olaznzapine EQ 12mg Base

Decision: Registration Board approved the grant of registration with ―USP
Specifications‖ for Co-Dep 12/25 Capsule‖ of M/s. Nabiqasim Industries
Private Limited, Karachi.Formulation/ Label claim shall be standardized in
accordance with the standard formulation approved by Reference
Regulatory Authorities. Furthermore, for verification of fee challan,
procedure shall be adopted as approved by the Board vide its 285 th meeting.
Case No.28. Request For Change in Formulation (Dosage form)of Products Approved in
the Name of M/s Le Mendoza Pharmaceutical (Pvt) Ltd, Karachi.
Registration Board, in its 277th meeting held on 27-29th December, 2017, approved the
change in registration status of following products from M/s Chas. A Mendoza Karachi to its new
title i.eM/s. Le Mendoza Pharmaceuticals (Pvt.) Ltd., Karachi.
Sr. Renewal
Name of product along Initial Date Fee along
No Reg. No. Remarks validity till
with composition of Reg. with date
.
1. 058642 Azocam DS Capsules 10/10/2009 (Due date: Locally 09-10-2019
Each capsule contains: 09-10-2014) Manufactured
Azithromycin as Rs.30,000/-
dihydrate … 500mg 04-12-2017
2. 017658 Ciprocam Capsule 18/07/1995 (Due date: Locally 17-07-2020
250mg 17-07-2015) Manufactured
Each capsule contains:- Rs.30,000/-
Ciprofloxacin Hcl eq. to 04-12-2017
Ciprofloxacin …250mg
3. 017659 Ciprocam Capsules 18/07/1995 (Due date: Locally 17-07-2020
500mg 17-07-2015) Manufactured
Each capsule contains:- Rs.30,000/-
Ciprofloxacin Hcleq to 04-12-2017
Ciprofloxacin …500mg
The approval letter of above mentioned products to new title of the firm were pending
due to non-availability of above mentioned formulations in ―Capsule‖ dosage form in
RRAs.However, these formulations are available in Tablet dosage form.
Now the firm has requested for revision of above mentioned formulations to ―Tablet‖
dosage form & submitted fresh applications on Form-5 along with fee of Rs.20,000/- for each
product.(Dy.Nos. 43736, 16322, 16323/R&I. with date 24-12-2018& 03-05-2018 respectively)

i. Cancellation of registration of products at S.No. 1-3 of above table.
ii. Approved the grant of new registrations for revised formulations of
above mentioned products at S.No. 1-3 in ―Tablet dosage form‖.

Case No.29. Approved Products of M/s SNB Pharma (Pvt) Ltd. Peshawar.
Registration Board in its 237th& 238th meeting considered the following products
of M/s SNB Pharma (Pvt) Ltd. Peshawar as per below mentioned details:
M-237
ANOMALY
Decision:-The Registration Board referred the applications (after submission of differential fee for registration)
to committee comprising Brig. (R). Prof. Dr. Muzammil Hassan Najmi (Member Registration Board), Dr.
Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam University, Islamabad
(Member Registration Board), DDG (Reg-II) and concerned DDC‘s/ADC‘s for scrutiny, verification of codal
requirements and recommendations for me-too registration applications. The recommendations of committee
will be submitted to the Chairman, Registration Board for decision.
S. Name of Name of Drugs /label AU Price Date Remarks Current Status
No Firms Claim
1. M/s. SNB Diclo-P 75 mg Tablets 10‘s As Per 24-5- Approved / Applied pack
Pharmaceutic Each film coated tablet SRO 2011 Remaining size:
als Peshawar contains:- 4/6 3x10‘s
New License Diclofenac Decision of M-
Potassium……75 mg 258 regarding
(Antirheumatic) de-registration
of instant
formulation.
2. -do- Domp 10 mg Tablets 50‘s As Per -do- Do Applied pack
Each tablet contains:- SRO size:
Domperidone ……..10 mg 10‘s
(Anti-Dopamineragic)
3. -do- SNfer Tablets 10‘s As Per -do- do Applied pack
Each tablet contains:- SRO size:
Iron (III) hydroxide 3x10‘s
Polymaltose
≡ Iron (Element)...100 mg
Folic Acid……….0.35 mg
(Anti-anaemic)
4. -do- L-Floxin 250 mg Tablets 10‘s As Per -do- do -
Each film coated tablet SRO
contains:-
Levofloxacin Hemihydrate
≡ Levofloxacin... 250mg
(Quinolone)
5. -do- L-Floxin 500 mg Tablets 10‘s As Per -do- do -
contains:-
Levofloxacin Hemihydrate
≡ Levofloxacin.. 500mg
(Quinolone)
6. -do- SNVasc Tablets 2x10‘ As Per -do- do -
Each tablet contains:- s SRO
Amlodipine (as
besylate)…..5 mg
(Calcium Antagonist)
7. -do- Neuromine Tablets 100‘s As Per -do- do Standard
Each film coated tablet SRO formulation
contains:- approved by
Mecobalamine..500 mcg RRAs is
(Antianamic) ―sugar coated‖

Applied pack
size:
2x10‘s
8. -do- Naprox 275 mg Tablets 20‘s As Per -do- do Applied pack
Each film coated tablet SRO size:
contains:- 1x10‘s
Naproxen
Sodium………275 mg
(Antirheumatic)
9. -do- Naprox 550 mg Tablets 20‘s As Per -do- do Applied pack
Each film coated tablet SRO size:
contains:- 1x10‘s
Naproxen Sodium ..550mg
(Antirheumatic)
10. -do- Diclo-S 50 mg Enteric 10‘s As Per -do- do Applied pack
Coated Tablets SRO size:
Each enteric coated tablet 3x10‘s
contains:-
Diclofenac
Sodium……..50 mg
(Anti-rheumatic)
11. -do- L-Vcit 10 mg Tablets 10‘s As Per -do- do -

contains:-
Levocetirizine (as 2HCl)
…..10 mg
(Antihistamine)
12. -do- Famo 40 mg Tablets 10‘s As Per -do- do -
contains:-
Famotidine………..40 mg
(H2- Blocker)
13. -do- SNalfa Tablets 3x10‘ As Per -do- do -
Each tablet contains:- s SRO
Alfacalcidol …..0.5 μg
(20.I.U.)
(Vitamin D analogue)
M-238
S. Name of Name of Drugs /label AU Price Date Remarks
No. Firms Claim
14. M/s. SNB Famot 10mg Suspension 60ml As Per 22-5- Approved Decision of M-
Pharmaceutica Each 5ml contains:- SRO 2012 subject to 250 regarding
ls, Peshawar Famotidine………10mg correction revision of
(H2 Blocker) in formulation.
compositio
n
However the
Registration
Board
advised the
Registration
sections to
again review
the
Registration
Dossiers

before
issuance of
Registration
letters
15. -do- Cefim 200mg Dry 30ml As Per -do- -do- Standard
Suspension 60ml SRO formulation
Each 5ml contains;- contains
Cefixime………200mg ―Cefixime as
(Cephalosporin) trihydrate….200
mg/5ml‖
Original dossiers along with fee challans of products at S.No.1-13 of above table have been
retrieved from record. However, recommendations of committee could not be
retrieved.Furthermore, the firm has now requested for issuance of registration letter & provided
following documents:
i. Copy of DML dated 20-09-2012.
ii. Evidence for Approval of following sections:
 Dry Suspension (General)
 Liquid Syrup (General)
 Cephalosporin (Capsule & Dry Powder Suspension)
iii. Last Inspection report dated 17-10-2018Conclusion is as under,
The firm has finished maintenance work and the plant is ready for production activities.
The firm had already requested for approval of start production after their volunteer stop
production to regulate then supply of medicines to market. They are committed to comply
cGMP guidelines. The panel agrees with the firm for resumption of their production after
volunteer stop production.

i. Approved grant of registration for the products at S.No. 2-6, 8-10 & 12-
13 of above table.
ii. Rejected the product at S.No.1 in accordance with the decision taken by
the Board vide its 258th meeting.
iii. Deferred the products at S.No.7 & 15 for submission of revised
formulation as approved by Reference Regulatory Authorities along
with requisite fee for revision.
iv. Deferred the product at S.No.11 for submission of evidence confirming
approval status in Reference Regulatory Authorities.
v. Deferred the product at S.No.14 in accordance with the decision taken
by the Board vide its 250th meeting.

Case No.30. Change in Formulation of Approved Product of M/s Noa Hemis
Pharmaceutical, Karachi
Registration Board in its 256th meeting approved the following product of M/s
NoaHemis, Karachi
S/N Name and Brand Name Type of Form International Decision
address of (Proprietary name + Initial date, status in stringent
manufacturer / Dosage Form + diary regulatory
Applicant Strength) Fee including agencies
Composition differential fee Me-too status
Pharmacological Group Demanded GMP status as
Finished product Price / Pack size depicted in
Specification inspection report
(dated)
1 M/s NoaHemis Clinac Gel Form 5 MHRA approved Approved
Pharmaceuticals Each gram contains Rs. 20000/- vide Dalacin
, Plot # 154, Clindamycin Phosphate Dy. No. 167 Dalacin–Pfizer
Sector 23, 20mg dated 17-9-2011 GMP compliant
Korangi Anti acne & 10-04-2014 section vide
Industrial Area, USP specifications Pack size of inspection report of
Karachi 10gm Rs.145/- panel dated 02-2-
2015.
The firm has now requested for change in above mentioned formulation to ―Clindamycin
Phosphate eq. to Clindamycin 10mg (1%w/w), stating the reason of non-availability of applied
formulation in Reference Regulatory Authorities. Detail is given below:
S/N Name of Product Previously Applied Revised Formulation
applied for registration Formulation
1. Clinac 1% Gel Each gram contains: Each gram of gel contains:
Clindamycin Phosphate.......20mg Clindamycin Phosphate eq. to
Clindamycin……10mg (1%w/w)
In this regard, the firm has submitted fresh application along with fee of Rs.20,000/- and
last inspection report dated 28-02-2019 for renewal of DML.
Decision: Registration Board approved the change in formulation of Clinac Gel as per
following details:
Clinac 1% Gel
Each gram of gel contains:
Clindamycin Phosphate eq. to Clindamycin……10mg (1%w/w)
Case No.31. Verification of Authentication of Stability Data Submitted For Xenase Nasal
Spray of M/s Sante (Pvt) Ltd., Karachi.
Registration Board in its 243rd meeting deferred registration of following products
of M/s Sante (Pvt) Ltd., Karachi and decided as recorded in last column.
Ear/Nasal drops Xenase Rs.800/15ml 1.Form-5D 1. PATANASE Deferred for
(General) Nasal Spray Plastic 2. 23-11-2011 (ALCON PHARMS (i) expert
section vide Each100 micro liter Bottle Dy.No.379 LTD) SPRAY, opinion
letter no F.2- contains: Rs.15000/- METERED;NASA (ii) Product
12/2006-lic Olopatadine 3. 08-04-2013 L OLOPATADINE Specific
dated 25-02- hydrochloride…… Rs.35,000/- HYDROCHLORID Inspection for
2011 ……..665mcg E 0.665MG/SPRAY manufacturin
equivalent to 0.6% (FDA) g facility.
(600mcg) of base. 2.Acceptable level
(Anti Allergic) of GMP (09.05.13)

According to the decision of 243rd meeting of Registration Board the Product Specific Inspection
of premises was conducted by Director DTL (Mr. Abdul RazzaqJawinda) and Area FID (Syed
Hakim Masood) on 16th April, 2015. The panel was of the view to recommend Registration of
Xenase Nasal Spray (OlopatadineHCl 0.6% w/v) to the firm subject to the approval of
Competent Authority. Regarding expert opinion since product is FDA approved there is no need
to take opinion as per M-250 decision of Registration Board.
Registration Board in its 256th meeting approved the request of the firm for grant of registration
of above product i.e. Xenase Nasal Spray.
At the time of issuance of registration letter it was observed that the product is new molecule and
registration letter was not issued. The firm was asked to provide stability studies as per decision
of the Registration Board. Later on, the firm provided stability studies and the case was
reconsidered in M-286 with following decision:
Decision of M-286: Registration Board deferred the case for onsite investigation to confirm
genuineness/ authenticity of stability data and associated documents submitted by the firm. The
Board further advised that the panel shall be constituted without waiting for confirmation/
finalization of minutes of 286th meeting.
In line with the decision of M-286, a panel comprising of following members was constituted:
i. Dr. Ghulam Sarwar, Member Registration Board
ii. Mr. Affan Qureshi, Assistant Director, CDL, Karachi
iii. Area FID

Xenase (Olopatadine) 0.6% w/v Nasal Spray by M/s. Sante Pharma Pvt. Ltd., Karachi.
Reference No: F.3-9/2018-Reg-II (M-286) (Misc) dated 21st December, 2018.

Investigation Date and Time: 28th December, 2018 (Afternoon).
Investigation Site: Factory premises of M/s. Sante Pharma, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Sante Pharma, Karachi for
registration of Xenase (Olopatadine) 0.6% w/v Nasal Sprayand constituted a three-member panel
to investigate the authenticity / genuineness of data (import of raw material and stability data).
Panel was advised to conduct inspection of the firm and to submit report for further
consideration.
4. Prof Ghulam Sarwar, Dean Faculty of Pharmacy, Jinnah University for Women (Member
Registration Board)
5. Mr. Abdul Rasool Shaikh, Area FID, DRAP, Karachi.

The investigation was conducted by using a structured questionnaire of DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used

and retained, personnel involved, ongoing studies, printed data and integrity and security of data
in respective databases were also audited. The details of investigation may be summar ized as
under:
Xenase (Olopatadine) Nasal Spray
Sr. Question Observation by panel
No.
1 Do you have documents confirming the import of The firm has imported Olopatadine 1kg batch #
API ? V0673/0 15030 vide invoice # 20151730 dated 23-12-
2015 and obtained approval from DRAP Karachi
2 What was the rationale behind selecting the There is proper vendor qualification being
particular manufacturers of APIs? implemented by the firm which include a desktop
audit by means of a questionnaire which is filled by
the manufacturer, GMP Status, provision of DMF and
stability data etc.
The manufacturer was evaluated on above mentioned
criteria. The same source is being used in another
registered eye preparation as well.
3 Do you have documents confirming the import of The firm has documents confirming the import of API
API reference standard and impurity standards? USP reference standard and impurity standards.
4 Do you have certificate of Analysis of the API, The firm has certificates of analysis for API, USP
reference standards and impurity standards? reference standard and their impurities.
5 Do you have any approval of API or GMP The firm has GMP certificate of Olopatadine
certificate of API manufacturer issued by Manufacturer M/s Crystal Pharma, Spain issued by
regulatory authority of country of origin? Spanish Agency of Medicine and Sanitary Products
(AEMPS).
6 Do you use API manufacturer method of testing? The firm has used USP method of testing for API.
7 Do you have stability studies reports on API? The firm has accelerated stability studies reports of six
months and five years real time stability studies
reports on Olopatadine.
performed as per SIM method and degradation method and degradation products have been
9 Do you have method for quantifying the impurities The firm has USP method for quantifying the
in the API? impurities in the API.
10 Do you have some remaining quantities of the API, The firm has remaining quantities of API and
its reference standard and impurities standards? reference standard of API.
11 Have you used pharmaceutical grade excipients? The firm has used pharmaceutical grade excipients.
12 Do you have documents confirming the import of The firm has documents confirming the procurement
the used excipients? of all excipients used.
13 Do you have test reports and other records on the The firm has test reports and other records on the
excipients used? excipients used.
14 Do you have written and authorized protocols for The firm has written and authorized protocols for the
the development of API nasal solution? product development.
15 Have you performed Drug-excipient compatibility Drug-excipients compatibility studies were not
studies? performed as the firm has used the same excipients as
of innovator ―Patanase‖ manufactured by Alcon
Laboratories USA.
16 Have you performed comparative dissolution N/A
studies?
17 Do you have product development (R&D) section The firm has R&D section which include facilities for
manufacturing.
18 Do you have necessary equipment available in The firm has necessary equipment for product
product development section for development of development of API Nasal Spray. The product in
API Nasal Spray? question has been developed while using some
equipment of commercial manufacturing also.

No.
Furthermore, the analytical part has been performed
via the routine quality control equipment. Firm has
already placed orders for procurement of other
equipment for this section.
19 Are the equipment in product development section The available equipment in product development
qualified? section are qualified.
20 Do you have proper maintenance / calibration / re- The firm has SOP for the
qualification program for the equipment used in PD maintenance/calibration/requalification of equipment
section? used on PD section.
21 Do you have qualified staff in product development The firm has qualified staff which include One
section with proper knowledge and training in Chemist and Two Pharmacists in product
product development? development section with relevant work experience.
22 Have you manufactured three stability batches for The firm has manufactured three consecutive stability
the stability studies of API nasal solution as batches for the accelerated and real time stability
required? studies of Xenase Nasal Spray packed in LDPE
bottles of 15ml each.
Batch No. Batch Size Mfg Date
03T 1000ml 05-2016
04T 1000ml 09-2016
05T 1000ml 09-2016
23 What was the criteria for fixing the batch size of The criteria for fixing the batch size of stability
stability batches? batches is the number of bottles per testing and the
number of bottles required for whole stability testing.
used has been available with the firm.
25 Do you have protocols for stability testing of The firm has detailed protocol for stability testing of
stability batches? stability batches in which the stability conditions are:
Real Time: 30°C and 65% RH
Accelerated: 40°C and 75% RH,
however, the firm has used LDPE container for the
product in question for which ICH guidelines and
WHO recommends 30°C and 35% RH for real time
and 40°C and 25% RH for accelerated stability
studies.
26 Do you have developed and validated the method The firm has developed and validated their own
for testing of stability batches? method for testing of stability batches in light of USP
method for Ophthalmic Solution. The method is
supported by impurities standards spiking studies,
forced degradation, hence capable of quantifying the
degradation products in their nasal spray.
27 Do you have method transfer studies in case when Not Applicable
the method of testing being used by your firm is
given by any other lab?
qualification of equipment / instruments being used qualification of equipment / instruments being used in
in the test and analysis of API and the finished the test and analysis of API and finished drug.
drug?
29 Do your method of analysis stability indicating? The firm‘s method of analytical testing has stability
indicating parameters.
31 Can you show Audit Trail reports on API testing? The firm showed the audit trail reports on API testing.
32 Do you have some remaining quantities of The firm has completed both accelerated and real time
degradation products and stability batches? stability studies however a few bottles were available
No.
with the firm.
33 Do you have commitment batches kept on stability The firm has completed both accelerated and real time
testing? stability studies
equipment used in API nasal solutions production used in Xenase Nasal Spray production and analysis.
in analysis?
35 Do proper and continuous monitoring and control Continuous power supply and monitoring are
are available for stability chamber? available for stability chambers.
personnel and utilities be rated as GMP compliant? and utilities be rated as GMP compliant.
Discussion:
1. On the basis of risk-based approach the genuineness / authenticity of stability data,
associated documents, import of API, quality, specification, test analysis, facilities as
submitted by the firm for registration of Xenase (Olopatadine) 0.6% Nasal Spray is
verifiable to satisfactory level.
2. Furthermore, the firm has conducted the stability studies as per their protocol which is
30°C and 65% RH for real time and 40°C and 75% RH for accelerated stability studies,
whereas, the recommended stability conditions for products packed in semi-permeable
containers are 30°C and 35% RH for real time and 40°C and 25% RH for accelerated
stability studies. However, 30°C and 65% RH for real time and 40°C and 75% RH for
accelerated stability studies may be used for semi-permeable containers provided the
calculated water loss multiplied with the corresponding factor may not exceed 5% of
initial, which is considered as significant change.
3. In this case the firm has not calculated water loss at any stage, so no comparison can be
made between the reference and alternative relative humidity as mentioned in ICH Q1A
(R2) (2.2.7.3. Drug products packaged in semi-permeable containers).
4. On risk-based approach the data evaluated during inspection does not show any deviation
in the critical tests throughout the study period which may be altered if the water has lost
more than the prescribed limits.
5. The related manufacturing area, equipment, personnel and utilities are GMP compliant
and well suited for the manufacturing of Xenase (Olopatadine) 0.6% Nasal Spray.
Recommendations:
The firm may be granted necessary registration of Xenase (Olopatadine) 0.6% Nasal Spray in
their name with the direction to conduct stability studies on their commitment batches as per ICH
guidelines i.e. 30°C and 35% RH for real time and 40°C and 25% RH for accelerated stability
studies and submit the data to the Drug Registration Board.
Decision of M-286: Registration Board deferred the case for submission of stability data at
next time point of long term stability studies along with assessment of water loss rate for appl ied
container closure system as per ICH Q1A (R2) guidelines for “Stability Testing of New Drug
Substance and Products.”
In line with the above mentioned decision, the firm later on submitted following information,
presented in 288th meeting of Registration Board:

General Study of Water loss
on Semi permiable Packaging material (LDPE)
Product : Xenase Nasal Spray
Batch No. 07T
Storage condition 40°C / 75% RH
(1st Interval)
Bottle No. Initial wt. (I) gm Final Wt (F) gm Difference (gm) Ratio
Date : 31-12-2018 Date : 07-01-2019 I-F Diff * 3
1 24.7534 24.7445 0.0089 0.0267
2 25.3129 25.3089 0.0040 0.0120
3 25.1638 25.1461 0.0177 0.0531
4 25.3596 25.3501 0.0095 0.0285
5 25.5955 25.5905 0.0050 0.0150
(2nd Interval)
Date : 31-12-2018 Date : 14-01-2019 I-F Diff * 3
1 24.7534 24.7432 0.0102 0.0306
2 25.3129 25.3047 0.0082 0.0246
3 25.1638 25.1253 0.0385 0.1155
4 25.3596 25.3447 0.0149 0.0447
5 25.5955 25.5875 0.0080 0.0240
(3rd Interval)
Date : 31-12-2018 Date : 21-01-2019 I-F Diff * 3
1 24.7534 24.7414 0.0120 0.0360
2 25.3129 25.2948 0.0181 0.0543
3 25.1638 25.0919 0.0719 0.2157
4 25.3596 25.3404 0.0192 0.0576
5 25.5955 25.5813 0.0142 0.0426
(4th Interval)
Date : 31-12-2018 Date : 28-01-2019 I-F Diff * 3
1 24.7534 24.7398 0.0136 0.0408
2 25.3129 25.2858 0.0271 0.0813
3 25.1638 25.0658 0.0980 0.2940
4 25.3596 25.3359 0.0237 0.0711
5 25.5955 25.5723 0.0232 0.0696
(1st Interval)
Date : 31-12-2018 Date : 07-01-2019 I-F Diff * 3
1 25.1325 25.1306 0.0019 0.0057
2 23.7190 23.7164 0.0026 0.0078
3 25.4003 25.3968 0.0035 0.0105
4 25.5157 25.5146 0.0011 0.0033
5 25.8982 25.8977 0.0005 0.0015

(2nd Interval)
Date : 31-12-2018 Date : 14-01-2019 I-F Diff * 3
1 25.1325 25.1283 0.0042 0.0126
2 23.7190 23.7135 0.0055 0.0165
3 25.4003 25.3923 0.0080 0.0240
4 25.5157 25.5142 0.0015 0.0045
5 25.8982 25.8974 0.0008 0.0024
(3rd Interval)
Date : 31-12-2018 Date : 21-01-2019 I-F Diff * 3
1 25.1325 25.1199 0.0126 0.0378
2 23.7190 23.7051 0.0139 0.0417
3 25.4003 25.3821 0.0182 0.0546
4 25.5157 25.5131 0.0026 0.0078
5 25.8982 25.8920 0.0062 0.0186
(4th Interval)
Date : 31-12-2018 Date : 28-01-2019 I-F Diff * 3
1 25.1325 25.1135 0.0190 0.0570
2 23.7190 23.6986 0.0204 0.0612
3 25.4003 25.3736 0.0267 0.0801
4 25.5157 25.5122 0.0035 0.0105
5 25.8982 25.8868 0.0114 0.0342
(1st Interval)
Date : 31-12-2018 Date : 07-01-2019 I-F Diff * 1.9
1 25.1325 25.1306 0.0019 0.00361
2 23.7190 23.7164 0.0026 0.00494
3 25.4003 25.3968 0.0035 0.00665
4 25.5157 25.5146 0.0011 0.00209
5 25.8982 25.8977 0.0005 0.00095
(2nd Interval)
Date : 31-12-2018 Date : 14-01-2019 I-F Diff * 1.9
1 25.1325 25.1283 0.0042 0.00798
2 23.7190 23.7135 0.0055 0.01045
3 25.4003 25.3923 0.0080 0.0152
4 25.5157 25.5142 0.0015 0.00285
5 25.8982 25.8974 0.0008 0.00152
(3rd Interval)
Date : 31-12-2018 Date : 21-01-2019 I-F Diff * 1.9
1 25.1325 25.1199 0.0126 0.02394
2 23.7190 23.7051 0.0139 0.02641
3 25.4003 25.3821 0.0182 0.03458
4 25.5157 25.5131 0.0026 0.00494

5 25.8982 25.8920 0.0062 0.01178
(4th Interval)
Date : 31-12-2018 Date : 28-01-2019 I-F Diff * 1.9
1 25.1325 25.1135 0.0190 0.0361
2 23.7190 23.6986 0.0204 0.0388
3 25.4003 25.3736 0.0267 0.0507
4 25.5157 25.5122 0.0035 0.0066
5 25.8982 25.8868 0.0114 0.0217
Detail of Supporting Documents Provided by the Firm/Observations:

 As protocol & testing method, the firm has only provided ICH guidelines for stability
testing of drug products packaged in Semi-Permeable containers.
 The firm has submitted water loss test results on Real Time storage conditions by
multiplying with following 2 different ratios (i.e., Ratio of water loss rates at a given
temperature as per ICH guidelines)
―3‖ (initially)
―1.9‖ (after clarification sought in the light of ICH guidelines).
 As per ICH guidelines:
―A 5% loss in water from its initial value is considered a significant change for a product
packaged in a semi-permeable container after an equivalent of 3 months‘ storage at
40°C/NMT 25% RH. However, for small containers (1 mL or less) or unit-dose products, a water
loss of 5% or more after an equivalent of 3 months‘ storage at 40°C/NMT 25% RH may be
appropriate, if justified‖.
Decision of M-288: Registration Board deliberated the case in the light of ICH Q1A (R2)
guidelines for “Stability Testing of New Drug Substance and Products”
and decided that the firm shall be directed to submit following
information/documents:
i. Data to demonstrate that the drug product will not have significant
water loss (i.e., 5% loss in water from its initial value) after an
equivalent of 3 months‟ storage.
ii. Data to demonstrate linear water loss rate at the alternative
relative humidity over the storage period.

The firm has now provided following information:

on Semi permeable Packaging material (LDPE)
Batch No. 07T
Manufacturer : Sante Private Ltd.
Bottle 1 Bottle 2 Bottle 3 Bottle 4 Bottle 5

31.12.18 (Initial Weight) 25.1721 25.4129 25.4128 25.2248 25.7429
14.01.19 (15 days) 25.1695 25.4087 25.4085 25.2191 25.7352
29.01.19 (30 days) 25.1622 25.4032 25.3965 25.2152 25.7287
13.02.19 (45 days) 25.1587 25.3977 25.3903 25.2093 25.7253
28.02.19 (60 days) 25.1522 25.3925 25.3825 25.2049 25.7177
15.03.19 (75 days) 25.1491 25.3842 25.3792 25.1977 25.7145
30.03.19 (90 days) 25.1409 25.3791 25.3754 25.1893 25.7047
% Water Loss Bottle 1 Bottle 2 Bottle 3 Bottle 4 Bottle 5

14.01.19 (15 days) 0.0103 0.0165 0.0169 0.0226 0.0299
29.01.19 (30 days) 0.0393 0.0382 0.0641 0.0381 0.0552
13.02.19 (45 days) 0.0532 0.0598 0.0885 0.0614 0.0684
28.02.19 (60 days) 0.0791 0.0803 0.1192 0.0789 0.0979
15.03.19 (75 days) 0.0914 0.1129 0.1322 0.1074 0.1103
30.03.19 (90 days) 0.1239 0.1330 0.1472 0.1407 0.1484
% loss * 1.9 Bottle 1 Bottle 2 Bottle 3 Bottle 4 Bottle 5

14.01.19 (15 days) 0.01962 0.03140 0.03215 0.04293 0.05683
29.01.19 (30 days) 0.07473 0.07252 0.12187 0.07231 0.10481
13.02.19 (45 days) 0.10114 0.11364 0.16822 0.11675 0.12990
28.02.19 (60 days) 0.15021 0.15252 0.22654 0.14989 0.18599
15.03.19 (75 days) 0.17360 0.21458 0.25121 0.20412 0.20961
30.03.19 (90 days) 0.23550 0.25271 0.27962 0.26740 0.28194

on Semi permeable Packaging material (LDPE)
Batch No. 07T
Manufacturer : Sante Private Ltd.
Bottle 1 Bottle 2 Bottle 3 Bottle 4 Bottle 5

31.12.18 (Initial Weight) 25.7189 25.1465 25.6543 25.8701 25.6406
14.01.19 (15 days) 25.7147 25.1407 25.6492 25.8639 25.6322
29.01.19 (30 days) 25.6993 25.1359 25.6407 25.8569 25.6282
13.02.19 (45 days) 25.6937 25.1287 25.6375 25.8501 25.6189
28.02.19 (60 days) 25.6892 25.1233 25.6310 25.8463 25.6107
15.03.19 (75 days) 25.6843 25.1185 25.622 25.8359 25.6059
30.03.19 (90 days) 25.6708 25.1087 25.6152 25.8288 25.5971
% Water Loss Bottle 1 Bottle 2 Bottle 3 Bottle 4 Bottle 5

14.01.19 (15 days) 0.0163 0.0231 0.0199 0.0240 0.0328
29.01.19 (30 days) 0.0762 0.0422 0.0530 0.0510 0.0484
13.02.19 (45 days) 0.0980 0.0708 0.0655 0.0773 0.0846
28.02.19 (60 days) 0.1155 0.0923 0.0908 0.0920 0.1166
15.03.19 (75 days) 0.1345 0.1113 0.1259 0.1322 0.1353
30.03.19 (90 days) 0.1870 0.1503 0.1524 0.1596 0.1697

% loss * 3 Bottle 1 Bottle 2 Bottle 3 Bottle 4 Bottle 5
14.01.19 (15 days) 0.0490 0.0692 0.0596 0.0719 0.0983
29.01.19 (30 days) 0.2286 0.1265 0.1590 0.1531 0.1451
13.02.19 (45 days) 0.2939 0.2124 0.1965 0.2319 0.2539
28.02.19 (60 days) 0.3464 0.2768 0.2725 0.2760 0.3498
15.03.19 (75 days) 0.4036 0.3340 0.3777 0.3966 0.4060
30.03.19 (90 days) 0.5611 0.4510 0.4572 0.4789 0.5090

Decision: Registration Board decided to approve registration of ―Xenase (Olopatadine)
Nasal Spray‖ by M/s Sante (Pvt) Ltd.,A/97 S.I.T.E Super Highway
Karachi.Manufacturer will place first three production batches of the
product on long term stability studies throughout proposed shelf life and on
Case No.32. Approved Product of M/s OBS Pakistan (Pvt) Ltd., Karachi
Registration Board in its 254th meeting held on 11-12th November, 2015

considered the following product of M/s OBS Pakistan (Pvt) Ltd., Karachi as per below
mentioned details:
Registration Board in 234th meetings deferred following registration application of M/s OBS
Pakistan (Pvt) Ltd., Karachi for expert opinion being new formulation:
S.# Name of firm(s) Pack size Demanded price
85. Andrex Gel 1% 5gm Rs.3000/-
Each 5 gm contains: 30‘s
Testosterone …….50 mg
(Hormonals)
Now, the firm has informed that they have developed sachet filling area (Hormone) and
considering the good manufacturing facility, Sachet filling area (Hormone) has been given
approval by the CLB. Furthermore, Andrex Gel 1% is approved by different regulatory
Authorities of the world including FDA and is available in market in various countries around
the world.
The firm have provided following with their claim:

i) Approval of additional section of Sachet (Hormones) Soft Gel.
ii) Evidence of approval of above generic in TGA
iii) Approval product in FDA.

Decision of M-254: Registration Board approved request of firm for registration of above
product (Andrex Gel 1%).
At the time of issuance of registration letter it was observed that the product is new
molecule and registration letter was not issued. The firm was asked to provide stability studies as
per decision of the Registration Board. Later on, the firm provided stability studies anda panel
comprising of following members was constituted:
i. Dr. RafeeqAlam Khan, Meritorious Professor, Department of Pharmacology,
University of Karachi. (Member Registration Board)
ii. Prof. Ghulam Sarwar, Dean Faculty of Pharmacy, Jinnah University for Women,
Karachi. (Member Registration Board)
iii. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.

Andrex (Testosterone) 1% Gel by M/s OBS Pakistan Pvt. Limited, C-14, Manghopir Road,
S.I.T.E, Karachi.
Reference No: F.3-1/2016-R-II (M-254) dated 8thFebruary, 2019.

Investigation Date and Time: 1st March, 2019. (Afternoon)
Investigation Site: Factory premises of M/s OBS Pakistan Pvt. Limited, C-14, Manghopir
Road, S.I.T.E, Karachi.
Background:
Chairman Registration Board considered the applications of M/s OBS Pakistan Pvt.
Limited, C-14, Manghopir Road, S.I.T.E, Karachi for registration of Andrex (Testosterone) 1%
Gel and constituted a three member panel to investigate the authenticity / genuineness of data
(import of raw material and stability data). Panel was advised to conduct inspection of the firm
and to submit report for further consideration.
1. Dr. RafeeqAlam Khan, Meritorious Professor, Department of Pharmacology, University
of Karachi. (Member Registration Board)
2. Prof. Ghulam Sarwar, Dean Faculty of Pharmacy, Jinnah University for Women,
Karachi. (Member Registration Board)


Andrex Gel 1% (Testosterone)
Q. NO. QUESTION OBSERVATION BY PANEL
1. Do you have documents confirming the Firm has procured 1.5kg testosterone import from M/S.
import of API including approval from IPCA Laboratories Limited, Gujarat, India having Batch
DRAP? number TST/M/002/15 vide Invoice No.MUM/2014-
15/5106 dated March 25, 2015 and obtained approval
from DRAP, Karachi.
2. What was the rationale behind selecting Selection of the manufacturer has been based upon its
the particular manufacturer of API? GMP Certification and availability of DMF (open part).
Supplier‘s assessment through postal audit.
3. Do you have documents confirming the The firm has procured working standards of API while
import of reference standard and impurity impurities are not included as per USP monograph.
standards?
4. Do you have certificate of analysis of API, The firm has certificate of analysis for API, Working
reference standards and impurity standards standards of APIs.
5. Do you have GMP certificate of API The firm has GMP certificate of API Manufacturer
manufacturer issued by regulatory issued by Drugs Control Administration, Government of
authority of country of origin? Ghandinagar, Gujarat, India.
6. Do you use API manufacturer method of The firm is using API manufacturer method for testing of
the testing for testing API? API which is as per USP monograph.
7. Do you have stability studies report on The firm has accelerated stability studies report of six
API? months and 36 months real time stability reports of API.
8. If yes, whether the stability testing has The stability testing has been performed as per USP
been performed as per SIM and monograph.
degradation products have been
quantified?
9. Do you have methods for quantifying the Not Applicable
impurities in API?
10. Do you have some remaining quantities of The firm has remaining quantities of the API & working
API, the reference standards and standard of API.
impurities?
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excepients?
12. Do you have documents confirming the The firm has necessary documents confirming the
import of used excepients? procurement of used excipients.
13. Do you have test reports and other records The firm has test reports & other record on the used
on the excepients used excipients.
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Andrex (Testosterone) Gel.
products?
15. Have you performed drug-excepient The firm hasn‘t performed drug-excipients computability
compatibility studies? study as same excipients of RLD brand used in
formulation.
Carbomer, Ethyl Alcohol, Isopropyl Myristate, Sodium
Hydroxide
16. Have you performed comparative Not Applicable
dissolution studies?
17. Do you have product development (R&D) The firm has dedicated area for product development
section? comprising manufacturing & testing facilities for trial
batches. However, the product in question has been
developed in Hormonal Manufacturing Area.
18. Do you have necessary equipment The firm has necessary equipment for production of trial
available in product development section batches in Hormonal Manufacturing Area.
for development of product?
19. Are the equipment in product The equipment used in production and analyses of trial
development section qualified? batches are qualified.
20. Do you have proper maintenance/ The firm has proper maintenance / calibration /
Q. NO. QUESTION OBSERVATION BY PANEL
calibration/requalification program for the requalification program for the equipment used in
equipment used in P&D section? production and QC Lab for trial batches.
21. Do you have qualified staff in product The firm has a team of 6 pharmacists for product
development section with proper development section and 2 pharmacist & 5 chemists in
knowledge and training in product analysis of trial batches with operators, with suitable
development? knowledge and training in product development.
22. Have you manufactured stability batches The firm has manufactured three stability batches for the
for the stability studies of the product as stability studies with following details:
required? Batch # Mfg date Batch size
EXP-G-01 June-2015 3.0 kg
EXP-G-02 June-2015 1.5 kg
EXP-G-03 Nov-2015 1.5 kg
The Gel is packed in Alu/Alu Sachet with pack size of
1x 10‘s.
23. Do you have criteria for fixing of the As per statement of the firm, the criteria for fixing the
batch size of stability batches? batch size of stability batches is the number of sachets
required for completion of stability studies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. Necessary log book of equipment used have
been available with the firm, assuring the traceability of
manufacturing and analyses of stability batches.
25. Do you have protocols for stability testing The firm has protocols for stability testing of Stability
of stability products? batches.
26. Do you have developed and validated the The firm has used method for testing of stability batches
method for testing of stability batches? of their finished product, which is stability indicating and
has validated while using the working standards of API
and also supported by forced degradation studies.
27. Do you have method transfer studies in Not Applicable.
case when the method of testing used by
your firm is given by another firm?
qualification of equipment/instruments qualification of equipment / instruments being used in
being used in the test and analysis of API the test and analysis of API and finished products.
and the finished products?
29. Do your method of analysis stability The firm method of testing is stability indicating for
indicating? stability testing of their finished product, as supported by
forced degradation studies.
30. Do your HPLC software 21 CFR The firm has used 21 CFR compliant HPLC.
compliant?
31. Can you show audit trail reports on Audit trail initially not activated. However, now audit
product testing? trail is activated from 12thmonths studies.
32. Do you have some remaining quantities The firm has completed stability studies while some
degradation products and stability quantities of working standard of the API available.
batches?
33. Do you have stability batches kept on The firm has completed the stability testing on the three
stability testing? stability batches of Andrex (Testosterone) 1% Gel.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment
the equipment used in production and used in production and analysis of Andrex (Testosterone)
analysis? 1% Gel.
35. Do proper and continuous monitoring and Continuous power supply and monitoring (data loggers)
control are available for stability are available for stability chambers. The data is properly
chamber? reviewed on daily basis.
personnel, and utilities be rated as GMP and utilities are rated as GMP compliant.
compliant?

CONCLUSION:
1. On the basis of risk-based approach the genuineness/authenticity of stability data
submitted by the firm for registration of Andrex (Testosterone) 1% Gel is verifiable to
satisfactory level.
2. The related manufacturing area, equipment, and utilities of Hormonal Section can be
rated as GMP compliant and are suited for the manufacturing of Andrex (Testosterone)
1% Gel.
3. Keeping in view the above statement the panel recommends grant of registration in the
name of manufacturer.
Decision: Registration Board decided to approve registration of ―Andrex
(Testosterone) 1% Gel‖ by M/s OBS Pakistan (Pvt) Ltd., Karachi.
Manufacturer will place first three production batches of the product on long
term stability studies throughout proposed shelf life and on accelerated
Case No.33. Approved Product of M/s GaxoSmithKline Pakistan Limited, 35-Dockyard

Road, West Wharf, Karachi.
Following product of M/s GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West
Wharf, Karachi was approved by the Registration Board in its 243 rd meeting, held on 08-09 May,
2014, as per following details:-
S Name & 1. Brand Name 1. Type of form 1. Me-too Status Decision
# Address of 2. Dosage Form 2. Type of application 2. GMP status
Manufactur 3. Composition 3. Demanded Price/
e/ Applicant 4. Pharmacological Pack size
Group 4. Initial date, diary
5. Date on which fee
becomes complete
according to type of
application/ or Form
(Total Fee)
1 M/s Panadol Joint Tablet 1. Form 5 A 1. Paracetamol- Approved
GaxoSmithK Each modified release 2. 20‘s Rs. 200/- Osteo 665mg with change
line Pakistan tablet contains: 3. 22-06-12 modified release in brand
Limited, 35- Paracetamol PhEur 4. 18-04-13 tablets approved name.
Dockyard 665mg modified release Rs.150,000/- by TGA
Road, West (Non narcotic 2. New Drug
Wharf, Analgesic) 3. Firm was
Karachi Finished product inspected on 20-
specifications are 01-2011 and
Manufacturer GMP compliance
was good.
The Cost & Pricing Division has now fixed the price of above mentioned formulation.
However, while possessing for issuance of registration letter, it was informed by the fir m that the
above mentioned application was made for bulk import and local repacking. In this regard the
firm has now provided revised Form- 5D (for being a new molecule) along with fee of Rs.5000/-
as per following details:
Name and address of Applicant M/s GaxoSmithKline Pakistan Limited, 35-Dockyard Road, West
Wharf, Karachi-74000
Name and address of manufacturer Manufacturing Site: M/s GaxoSmithKline Australia Pty Limited,
Consumer Healthcare Division, 82 Hughes Avenue, Ermington
NSW 2115, Australia.
Packaging Site: M/s GaxoSmithKline Pakistan Limited, F-268
S.I.T.E., Karachi (DML 000233)
Name of exporting country Australia
Type of Form Form 5-D
Brand Name +Dosage Form + Strength Panadol Joint Tablet
Composition Each modified release tablet contains:
Paracetamol……….665mg
Proposed Shelf life 48 months
Demanded Pack size & Price Rs. 200/- per 20‘s
International availability TGA Approved Panadol Back and Neck Long Lasting
Paracetamol 665mg Modified Release film coated Tablets
Me-too status N/A
Detail of certificates attached Notarized copy of CoPP
Certificate No. 11/0084
The facilities and operations conform to GMP as recommended
WHO.
Free sale: Confirms the free sale of the product in exporting
country.
GMP: Notarized copy of GMP Certificate based on inspection
GMP Status of Packaging site. Last GMP Inspection Report dated 11-09-2018.
―The firm is found to complying at good level of GMP
requirements at the time of inspection‖
DML of Packaging site. DML was issued/ renewed dated 10-07-2010. The firm has
applied for renewal of DML vide application dated 22-06-2015.
Details of Import, Packing & Batch Release:
M/s GaxoSmithKline Pakistan Limited, F-268 S.I.T.E., Karachi (DML 000233) will be responsible for
Complete testing and QC release of the product.
The firm has elaborated complete details of import, packing & batch release of finished product
Step # 1: Bulk labeled tablets of Pandaol Joint will be imported from M/s GaxoSmithKline Australia Pty
Limited, Consumer Healthcare Division, 82 Hughes Avenue, Ermington NSW 2115, Australia.
Step # 2: Complete testing will be performed as per requirement of tableting mentioned in QC release.
Step # 3: Bulk tablets will be packed in blisters, unit cartons and finally in master cartons. This packing activity
will be performed in GMP compliant facility located at GSK Pakistan Limited F-268 SITE, Karachi.
Step # 4: QC release & batch release of the final dosage form will be done by the GSK Pakistan limited.
The Board was further informed that original dossier of above mentioned case has been
traced along with Original & Legalized CoPP (Certificate No. 11/0084). However, requirement
of stability data needs deliberation.
Decision of M-288: Registration Board deferred the case for submission of stability data and
associated documents. The Board further advised that the panel shall be
constituted for onsite investigation to confirm genuineness/ authenticity of
submitted data/documents without waiting for confirmation/ finalization of
minutes of 288th meeting.
In line with the above mentioned decision of the Board, the firm provided stability
studies and a panel comprising of following members was constituted:
i. Dr.SaifurRehmanKhattak, Director, CDL, DRAP, Karachi.

ii. Dr. Najam us Saquib, Additional Director, DRAP Office, Karachi.
iii. Mr. Kirshan Das, Assistant Director, DRAP Office, Karachi.

Panadol Joint 665mg Tablets (Paracetamol) by M/s. GlaxoSmithKline Pakistan Limited,
S.I.T.E, Karachi.
Reference No: F.3-3/2019-Reg-I (M-288) dated 29th, April, 2019.

Investigation Date and Time: 08th May, 2019 (Morning).
Investigation Site: Factory premises of M/s. GlaxoSmithKline Pakistan
Limited, F-268 S.I.T.E, Karachi.
Background:
Chairman Registration Board considered the applications of M/s. GlaxoSmithKline
Pakistan Limited, F-268 S.I.T.E, Karachi for registration of Panadol Joint 665mg Tablets
(Paracetamol) and constituted a three-member panel to investigate the authenticity / genuineness
of data (import of raw material and stability data). Panel was advised to conduct inspection of the
firm and to submit report for further consideration.
1. Dr.SaifurRehmanKhattak, Director, CDL, DRAP, Karachi.
2. Dr. Najam us Saquib, Additional Director, DRAP Office, Karachi.
3. Mr. Kirshan Das, Assistant Director, DRAP Office, Karachi.

PANADOL JOINT 665MG TABLETS
S.
No
1. Do you have documents confirming the Around 7500 Panadol joint tablets were imported in
import of API including approval from bulk from miser GskErmington Australia. Via invoice
DRAP? number 142 dated 18th Dec 2013. With reference to
DRAP Islamabad letter # F.3-3/2012-IE/PT dated 10th
July 2013.
Three batches of bulk tablets were imported with batch
# 131707,131708 and 131751 each of 2500 tablets. The
manufacturing and expiry date of these three batches
were Aug 2013 and Aug 2017 respectively. Tablets for
imported in fibre drums. Approval from DRAP Karachi
for the release of the consignment was obtained on 08 th
Jan 2014.
2. What was the rationale behind selecting the Not applicable
particular manufacturer of API?

S.
No
3. Do you have documents confirming the Reference standard has been imported from Hamire
import of reference standard and impurity road, Barnard castle, co. Durham, DL12 8DT, UK
standards? bearing Catalogue number 5307 batch 8 for
paracetamol, bearing catalogue number 1481 batch 4 for
4-chloroacetanilide and bearing catalogue number 5305
batch 6 for p-aminophenol.
4. Do you have certificate of Analysis of the As above
API, reference standards and impurity
standards?
5. Do you have GMP certificate of API Not applicable.
manufacturer issued by regulatory authority
6. Do you use API manufacturer method of It is a bulk product tested vide the tablet manufacturing
testing for testing API? site (GskErmington Australia) method of testing.
7. Do you have stability studies reports on Although it is a bulk product however stability reports
API? of API are also available
8. If yes, whether the stability testing has been The stability has been performed as SIM it is available
performed as per SIM method and with the firm.
9. Do you have method for quantifying the Not applicable
impurities in the API?
10. Do you have some remaining quantities of API not applicable however some quantities of the
the API, its reference standard and reference standard and impurities are available.
11. Have you used pharmaceutical grade Not applicable
excipients?
12. Do you have documents confirming the Not applicable
import of the used excipients?
13. Do you have test reports and other records Not applicable
on the excipients used?
14. Do you have written and authorized Protocol for development is available. Complete testing
protocols for the development of applied of the bulk product is advised to be added in the
product? protocol and the related tests to be performed on receipt
of the bulk product. Moreover, holding time studies
should also be performed for the period between receipt
of the bulk product in conversion on packaging.
15. Have you performed Drug-excipients Not applicable
16. Have you performed comparative Since the product is that of innovator therefore only
dissolution studies? dissolution studies has been performed at Gsk site
17. Do you have product development (R&D) Not applicable
section
18. Do you have necessary equipments Not applicable
available in product development section
for development of applied product?
19. Are the equipments in product development Not applicable
section qualified?
20. Do you have proper maintenance / Not applicable
calibration / re-qualification program for the
equipment used in PD section?
S.
No
21. Do you have qualified staff in product Not applicable
development section with proper knowledge
22. Have you manufactured three stability The firm has packed (blistering and cartooning) three
batches for the stability studies of appliedbatches with batch number 01, 02 and 03 each of 125
product as required? packs of 20s.
23. Do you have any criteria for fixing the batch
DRAP reference letter for import of bulk tablets
size of stability batches? reference as above.
24. Do you have complete record of production The firm has complete record of import of bulk product
of stability batches? tablets (three batches) and there blistering and
cartooning.
25. Do you have protocols for stability testing The firm has authorised protocol for stability testing of
of stability batches? Panadol Joints tablets # STAB/STP-NP/968/02.
26. Do you have developed and validated the The firm has adopted Gsk Australia Ermington method
method for testing of stability batches? of testing. Proper method transfer studies has been
conducted.
27. Do you have method transfer studies in case As above
28. Do you have documents confirming the The firm has documents confirming the qualification of
qualification of equipments / instruments equipment‘s / instruments being used in the test and
being used in the test and analysis of API analysis bulk finished drug.
29. Is your method of analysis stability The firm has SIRM.
indicating?
30. Is your HPLC software is 21CFR The firm has HPLC compliant with 21CFR. audit trail
compliant? reports are available
(Details of Model, software, description/
version (i.e. software validation report for
21 CFR Part 11 compliance including audit
trail, password protection, date & time lock
and user authorizations shall also be
reported.)
31. Can you show Audit Trail reports on Audit trail reports on the testing are available
stability studies testing?
32. Do you have some remaining quantities of Since stability has been completed two years ago
degradation products and stability batches? therefore no stability batch or degradation products are
available with firm as such however a blister of 10
tablets batch number 03 was produced by the firm as a
reference for review of the panel
33. Do you have stability batches kept on Stability testing has already competed
stability testing?
34. Do you have valid calibration status for the The firm has valid calibration status of equipment‘s
equipments used in production and
analysis?
35. Do proper and continuous monitoring and The firm has continuous monitoring and control are
control are available for stability chamber? available for stability chamber.
(Number and utilized/available capacity of
stability chambers shall also be reported.)
personnel and utilities be rated as GMP and utilities be rated as GMP compliant.
compliant?

Conclusion:
1. On the basis of risk-based approach the genuineness / authenticity of stability data
submitted by the firm for registration of Panadol Joint tablet is verifiable to satisfactory
level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant
and suited for the manufacturing of Panadol Joint tablet.
Recommendation
1. Panadol Joint tablet is recommended for registration (bulk import and local packing) in
the name of the firm.
Decision: Registration Board decided to approve registration of ―Panadol Joint
Tablets (Paracetamol 665mg Modified Release)‖ in the name of M/s
GlaxoSmithKline Pakistan Limited, F-268 S.I.T.E., Karachi (DML 000233)
as per following details:
Bulk tablets will be imported from M/s GlaxoSmithKline Australia Pty
Limited, Consumer Healthcare Division, 82 Hughes Avenue, Ermington
NSW 2115, Australia and M/s. GlaxoSmithKline Pakistan Limited, F-268
S.I.T.E, Karachi will be responsible forblistering and packing oftablets
alongwith final quality control release of the finished pharmaceutical
product. Furthermore, first three production batches of the productwill be
placed on long term stability studies throughout proposed shelf life and on
Case No. 34. Grant of Registration OnPriority Basis In Lieu of Export Facilitation.
Registration Board, in its 288th meeting considered the following application of M/s
Medisure Laboratories (Pvt.) Limited, A-115, S.I.T.E., Super Highway, Karachi on priority basis
in lieu of export facilitation. Detail is as under:
Following pplication has been forwarded by registration-I section vide letter No. F.7-7/2017-Reg-II (Vol-II) for
priority consideration in lieu of Export facilitation
Name and address of manufacturer / M/s Medisure Laboratories (Pvt.) Limited, A-115, S.I.T.E., Super
Applicant Highway, Karachi
Brand Name +Dosage Form + Strength Ticalor tablet 90mg
Ticagrelor ………………..90mg
Pharmacological Group Platelet Aggregation Inhibitor
GMP status Last GMP inspection was conducted on 28-06-2018 and the report
concludes good GMP compliance.
XIII
formulation.
 Tablet General Section is available in the firm as mentioned in
the submitted section approval letter.
 Film- coating is not applied in the master formulation.
 Me- too status could not be confirmed.
 Stability is required against the applied formulation.
Decision: Deferred for application on Form 5-D along with submission of differentialfee and stability study
data as per the requirements of 278th meeting of Registration Board.
Now the firm has requested to replace the above mentioned molecule with new molecule detailed
below:
I II III IV
Sr.No Molecule/Generic Product Name & Composition Date of Submission of
Dossier
1. Lacosamide Lacoste 50mg Tablet 31-12-2018
Lacosamide………….50mg
Lacoste 100mg Tablet 31-12-2018
Lacoste Injection 31-12-2018
Each 20ml contains:
The case has been placed for deliberation whether a replacement can be made with an
item i.e., already considered on priority (in lieu of export facilitation) and deferred by the
Registration Board.
Decision: Registration Board acceded to the request of M/s Medisure Laboratories
(Pvt.) Limited, A-115, S.I.T.E., Super Highway, Karachi for replacement of
previously deferred application of Ticagrelor 90mg Tablet with
abovementioned Lacosamide Tablet Range for grant of registration on
priority basis in lieu of export facilitation.
Case No.35. Request of M/s. Muller & Phipps Pakistan (Private) Limited,Karachi .
M/s. Muller & Phipps Pakistan (Pvt.) Ltd. Uzma Court, Main Clifton Road, P.O.
Box3880-Karachi-75600 has requested that they have multinational distribution network for
national and multinational pharmaceuticals companies. On behalf of importers / manufacturers
they always participate in the institution tender business. As per the institution requi rements
outer / secondary packs must be stamped / over printed with the same of institution and wording
―Not for Sale‖. Their licensed warehouse has been approved by the Drug Regulatory Authority
of Pakistan for storage of biological and non-biological products.
They have provided following documents:-
i. Drug Regulatory Authority of Pakistan, Inspectors Approval reports.
ii. Provisional Establishment Certificate to Import Medical Devices provided in schedule-D.
iii. Copy of valid sale license.
iv. Authority letters for institutions of different manufacturers.
v. Fee of Rs. 5000/- for this purpose.
They have further quoted the SRO 470(I)/2017 and the medical devices Rules 2017, as under:-
1. Drugs (Labelling & Packing) Rules, 1986 (Rule 9A, Sub-rule (2):
―Where the imported drugs, at the time of import, do not confirm to the provision of sub-
rule (1), the person importing the drug shall make an arrangement at a local facility
licensed to manufactured drugs of sell the drugs in terms of clause (i) of Rule (3) of the
Drugs (Import & Export) Rules, 1976 with the prior approval of the Registration Board to
print the GSI Application, before the drug is placed in to the Pakistani Market.‖
2. Medical Devices Rules 2017: (Rule 38, Sub-rule (2):
―Where a medical devices has either not been appropriately labeled, or partially labelled
as mentioned in sub-rule (1), the importer on his request in this behalf may be allowed by
MDB to comply with these rules relating to labeling by printing the information of
establishment-license‘s details, enlistment or registration number, MRP or any other
information which may be required by MDB at establishment‘s licensed premises‖.
They have requested that the above stated proviso should also be extended to the
stamping / marketing on outer packs for Government Institution Supplies only, as the Drugs
(Labeling and Packing) Rules has been amended.
The PRVC in its 14th meeting referred the case for presenting in Registration Board.
Decision of M-286: Registration Board referred the case to Legal Affairs Division of DRAP
for opinion/ comments.
Comments furnished by Legal Affairs Division
The term ―label‖ is defined in the Drugs Act, 1976 as display of written, printed or graphic
matter upon the immediate container, or the outside container or wrapper of a drug package. As
per aforesaid Act, ―labeling‖ means all labels and other written, printed or graphic matter
accompanying any drug. The act defines ―manufacture‖ as all operations involved in the
production of the drug, including labeling with a view to its storage, sale and distribution.
Therefore, labeling is part of manufacturing process.
Rule 7 of the Drugs (Labeling and Packaging) Rules, 1986 deals with labeling of drugs for
Government supply. The said rule stipulates that the label of a container of every drug intended
for the supply to any Government agency including an autonomous body or a semi government
agency shall, while complying with other labeling requirements of 1986 rules, bear the words or
mark reading ―Government Supply‖ or such other words or mark as may be required by the
agency concerned.
In view of the above, labeling requirements including the addition of words ―Government
Supply‖ or ―Not for Sale‖, being part of drug manufacturing process, has to be carried out during
that process.
It is further clarified that S.R.O. 470(I)/2017 was issued to amend the 1986 rules to
include barcoding requirements. Rule 3A(2) of S.R.O. 2470(I)/2017 requires an importer to
make an arrangement at a local facility licensed to manufacture drugs or sell drugs to print the
GS1 application, if the imported drugs do not conform to the barcoding requirements at the time
of import, before the drug is placed in to the Pakistan market. The said rule only deals with
barcoding requirements. The provisions of Medical Devices Rules, 2017 cannot be extended to
labeling requirements of drugs under the 1986 Rules.
Decision: Registration Board deliberated the case in the light of comment

furnished by Legal Affairs Division of DRAP & decided that the
request of M/s. Muller & Phipps Pakistan (Private) Limited, Karachi
shall not be acceded.

Registration-II
Case No. 36: Allocation Of Quota For Control Substances Ephedrine HCl for the year
2017 to M/s. Sharex Laboratories, Sadiqabad.
The case of M/s. Sharex Laboratories, Sadiqabad was considered in 275 th and 286th meeting of
Registration Board as per detailed below:-
Proceedings of 275th of Registration Board:
The instant case was presented based on the letter received from Assistant Director (CD) (Dated
21st Sep, 2017) wherein it has been stated that M/s Sharex Laboratories, sadiqabad applied for
quota allocation of product ―Tracodil syrup (Reg. 003158). The case was presented before 43 rd
meeting of committee on allocation of controlled drug held on 26 th July, 2017, the comittee
deferred the case for issuance of show cause by DRAP for manufacturing of Tracodil syrup
(Reg. 003158) 60ml, 400ml pack without approval. It was requested to verify the status of
product registration of Tracodil syrup (Reg. 003158) 400ml pack size.
The approved pack sizes of product ―Tracodil Syrup‖ (Reg no. 003158) have been verified as per
available record i.e 120ml, 450ml (National Formulary 1981) and 60ml (dated 27 th October
1988).
Decision of 275th meeting of Registration Board:-
Registration decided to call M/s Sharex Laboratories, Sadiqabad for personal hearing and
for deliberating above mentioned matter before the Registration Board.
Proceedings of 286th meeting of Registration Board:-

Mr. Muhammad Ishfaq, production pharmacist, appeared before Registration Board and
apologized on behalf of the firm for applying quota of 400ml pack size of product ―Tracodil
syrup (Reg.003158) without approval.
Decision of 286th meeting of Registration Board:-

Registration Board in its 286th meeting decided to refer the case to Legal Affair division
for legal opinion.
Accordingly, the case was refer to Legal Affairs, Division and in response, Legal Affairs,
Division has provided following opinion:-
i. That M/s. Sharex Laboratory applied for the quota allocation of product ―Tracodil
Syrup‖ (Reg.No.003158).
ii. That the Committee on Allocation of Controlled Drugs held on 26.07.2017
deferred the case for issuance of show cause by DRAP for manufacturing of
―Tracodil Syrup‖ (Reg.No.003158) 60ml, 400ml pack without approval. It was
requested to verify the status of product registration of ―Tracodil Syrup‖
(Reg.No.003158) and 60ml (dated 27th October, 1988).
iii. That the approved pack size of the product ―Tracodil Syrup‖ (Reg.No.003158)
have been verified as per available record i.e 120ml, 450ml (National Formulary
1981) and 60ml (dated 27th October, 1988).
iv. That Mr. Muhammad Ishfaq production pharmacist, appeared in 286 th meeting
before Board and apologized on behalf of the firm for applying quota of 400ml
pack size of product ―Tracodil Syrup‖ (Reg.No.003158) without approval.
v. That the Registration Board in 286 th meeting referred the case to Legal Affairs,
Division for legal opinion.
vi. Drug Regulatory Authority of Pakistan Act, 2012 in Schedule-II A(1) (a) (vii)
prohibits export, import or manufacture and sale or sell of any therapeutic goods
which is not registered or is not in accordance with conditions of registration as

disclosed in the registration dossier and that has undergone pharmaceutical
evaluation. Furthermore, Schedule-II(A)(c) prohibits to sell any therapeutic goods
except under, and in accordance with the conditions of a license issued under this
Act. In addition, Schedule-II A(a)(f) prohibit to supply an incorrect, imcomplete
or misleading information when required to furnish any information under this
Act or the rules.
vii. In this regard, DRAP Act, 2012 under section 27 read with schedule-III (6)
provides penalty for violating the prohibitions mentioned above.
Decision: In light of the opinion of Legal Affair‘s Division on the matter, Registration
Board deliberated the case and decided to issue showcause notice to M/s
Sharex Laboratories, Sadiqabad for violation of condition of drug
registration, as follows:
 Cancellation of registration.
 Suspension of registration.
 Prosecution in Drug Court
Case No. 37: CASE OF UNIVERSITY OF SARGODHA (UOS) PHARMACEUTICAL

LABORATORIES, SARGODHA.
Dr. Muhammad Tahir, Haseeb, Incharge UOS Pharmaceutical Laboratories,
University of Sargodha has informed that they were granted the registration drugs vide letter
No.F.8-9/2017-Reg-III(M-273) dated 09-10-2018. He has further informed that a pharmaceutical
industrial unit (University of Sargodha Pharmaceutical Laboratories) was established by the
University of Sargodha for commercial and research purposes and requisite license was attained
from Drug Regulatory Authority of Pakistan vide license No. 000859, dated 21-06-2017 for this
purpose. The Syndicate of the university of Sargodha in its 1/2018 meeting held on 12-05-2018
has declared pharmaceutical industrial unit as research entity only, in order to provide strengthen
the research activities at UOS. Now, as per decision of the Syndicate, the above Industrial Unit
will be used only as ―Research and Training Unit‖ for pharmacy students and researchers, as
well as other integrated disciplines. This pharmaceutical industrial unit will not be run for
commercial purposes. He has submitted as under:-
a. This is for your kind information and subsequent necessary action in this regard
please.
b. He has requested to facilitate in this regard according to the law and licensing terms
to run above unit as research and training only.
It is pertinent to mentioned that UOS Pharmaceutical Laboratories, Sarghoda was granted
registration in 273rd meeting and registration letters were issued as per following details:-
S.No. Reg. No. Name of Drug(s) & Composition Packing MRP
1. 086170 Reinolex 250mg Tablet 10's Rs.130/-
Ciprofloxacin as hydrochloride …….250mg
(BP Specifications)
2. 086171 Reinolex 500mg Tablet 10's Rs.215/-
Ciprofloxacin as hydrochloride ……500mg
(BP Specifications)
3. 086172 Sarmed 50mg Tablet 20‘s Rs.60/-
Each enteric coated tablet contains:
Diclofenac sodium…………….50mg

4. 086173 Sarflam 50mg Tablet 20‘s Rs.60/-
Diclofenac potassium……….50mg
5. 086174 Accflam 100mg Tablet 10‘s Rs.75/-
Aceclofenac………………..100mg
(As per *Innovator‘s Specifications)
6. 086175 Zyrtezine 10mg Tablet 10‘s Rs.42/-
Cetirizine hydrochloride ………..10mg
7. 086176 Spondulac-B 20mg Tablet 20's Rs.175/-
Each tablet contains:
Piroxicam β cyclodextrin equivalent to piroxicam...20mg
(As per Innovator‘s Specifications)
8. 086177 Omepasec 20mg Capsule 14's Rs.144/-
Omeprazole enteric coated pellets eq.to Omeprazole
............................20mg
(BP Specifications)
9. 086178 Omepasec 40mg Capsule 2x7‘s Rs.250/-
Omeprazole enteric coated pellets equivalent to
omeprazole……….40mg
(BP Specifications)
10. 086179 Benzipep 20mg Capsule 2x7's Rs.119/-
Esomeprazole enteric coated pellets equivalent to
esomeprazole…….20mg
11. 086180 Benzipep 40mg Capsule 2x7's Rs.198/-
Esomeprazole enteric coated pellets equivalent to
esomeprazole…….40mg
12. 086181 Spondulac 20mg Capsule 10‘s Rs.71/-
Piroxicam ……………20mg
13. 086182 Nexafib 250mg Capsule 100's Rs.650/-
Tranexamic acid……………..250mg
(JP Specifications)
14. 086183 Sarmed 100mg Capsule 30‘s Rs.138/-
Diclofenac sodium enteric coated pellets equivalent to
Diclofenac sodium…….100mg
15. 086184 Leishnil 50mg Capsule 56's Rs.16,000/-
Miltefosine…………………50mg
(As per *Innovator‘s Specifications)

16. 086185 Nomalus Dry Suspension 30ml Rs.90/-
After reconstitution each 5ml contains:
Artemether ……………..15mg
Lumefantrine……………90mg
(IP Specifications)
17. 086186 Histoplasmazole Dry Suspension 35ml Rs.210/-
Fluconazole…….…………50mg
18. 086187 Olizid Dry Suspension 60ml Rs.350/-
Linezolid………100mg
19. 086188 Macclar 125mg Dry Suspension 60ml Rs.223/-
Clarithromycin taste masked granules …125mg
20. 086189 Macclar 250mg Dry Suspension 60ml Rs.368/-
Clarithromycin taste masked granules …250mg
21. 086190 Dimune-Z Oral Syrup 60ml Rs.60/-
Each 5ml contains:
Zinc sulphate eq. to elemental Zinc………20mg
22. 086191 Navostatin Oral Suspension 30ml Rs.48/-
Each 1ml contains:
Nystatin…………………100000 IU
23. 086192 Zyrtezine Oral syrup 60ml Rs.27/-
Each 5ml contains:
Cetirizine hydrochloride …….5mg
24. 092114 Contaflex 250mg Tablet 10‘s Rs.250/-
Levofloxacin hemihydrate eq. to Levofloxacin…250mg
25. 092115 Contaflex 500mg Tablet 10‘s Rs.416/-
Levofloxacin hemihydrate eq.to Levofloxacin...500mg
26. 092116 Firmivit-F 100mg Tablet 2x10‘s Rs.95/-
Each tablet contains:
Iron III hydroxide polymaltose complex equivalent to
elemental iron …………………….100mg
Folic acid………….0.35mg
(As per * innovator‘s Specifications)
27. 092117 Histoplasmazole 150mg Capsule 1‘s Rs.138/-
Fluconazole….150mg
(BP Specifications)
Decision: Keeping in view the decision of Central Licensing Board for cancellation of
Drug Manufacturing License the Registration Board deliberated and
cancelled the registrations of all drug products registered in the name of M/s
UOS Pharmaceutical Laboratories, University of Sargodha.
Case No.38: Pending Registration cases of M/s. Moringa Pharmaceuticals (Pvt.) Ltd.
Lahore.
The Registration Board in its 237 th meeting decided the following registration
applications of M/s. Moringa Pharmaceuticals (Pvt.) Ltd. Lahore. The details is as under:-
S. Name of firm(s) Name of Drug(s) with formulation Applied Applied Date of Decision of
No. pack size MRP Submission RB
1. M/s. Moringa Gabafit Capsules 150mg 2×7‘s Rs.350.00 22-1-2013 Deferred

Pharmaceuticals (Pvt.) Each capsule contains:-
Ltd. Lahore Pregabalin…150mg
New License (Anticonvulsant)
Sections
(i) Tablets (ii)
Capsules (iii) Dry
powder Suspension (iv)
Liquid syrup.
2. -do- Gabafit Capsules 75 mg 1x14‘s Rs.237.00 -do- Deferred
Each capsule contains:- for review.
Pregabalin…..75mg
(Anticonvulsant)
3. -do- Omefix-20 Capsules 20/1100 2×7‘s Rs.146.00 -do- Deferred
Each capsule contains:-
Omeprazole…20mg
(PPI & antacid)
4. -do- Omefix-40 Capsules 40/1100 2×7‘s Rs.252.00 -do- Deferred
Each capsule contains:-
Omeprazole…40mg
(PPI & antacid)
5. -do- Winpain Tablets 550mg 1×20‘s Rs.198.00 -do- Approved.
Each film coated tablet
contains:-
Naproxen Sodium…550mg
(NSAID)
6. -do- Fexal-120mg Tablets 10‟s Rs.120.00 -do- Approved.
Fexofenadine HCl…….120mg
(antihistamine)
7. -do- Fexal-180mg Tablets 10‘s Rs.169.00 -do- Approved.
Each film coated tablet
contains:-
Fexofenadine HCl…….180mg
(antihistamine)
8. -do- Methicol Tablet 500mcg 3x10‘s Rs.255.00 -do- Approved.
Each sugar coated tablet contains
Mecobalamin…..500mcg
(vitamin, endogenous coenzyme
B12)
The firm has again submitted application dossiers on Form-5 alongwith attested copy of challan
from treasury officer, Lahore of Rs. 1,60,000/-. GMP inspection of firm was conducted on 06-
06-2018 reflecting that firm do have Tablet (General & Antibiotic) and Capsules (General &
Antibiotics) sections. Firm has requested to issue the registration of above products.
Decision: Registration Board decided to approve the above-mentioned products in the
name of M/s M/s. Moringa Pharmaceuticals (Pvt.) Ltd. Lahore.

Import & Veterinary-I
VETERINARY CASES
Case No.39: M/s. Noble Pharmaceuticals, Old Industrial Area, Mirpur, AJK.
QA&LT Division of DRAP, Islamabad has forwarded the case of M/s. Noble Pharma,
Mirpur Azad Kashmir that Federal Inspector of Drugs-III, Islamabad performed routine GMP
inspection of M/s. Noble Pharma, Mirpur Azad Kashmir on 16-11-2018 wherein it has been
observed that the firm has following two registered penicillin containing products but has no
separate penicillin manufacturing section (veterinary).
S.No Reg. No. Name of drug(s) & Composition.
1. 058725 Nobi-PSBC Powder
Each 1000gm contains:-
Procain Penicillin…………12gm
Streptomycin Sulpahte……36gm
Zinc Bacitracin……………52gm
Colistin Sulpahte…………..60IU
2. 071009 Nobimox Powder
Each Kg contains:-
Amoxycillin Trihydrate….150gm
Colistine Sulphate…..….50 M.I.U
Decision:- Registration Board decided to issue show cause notice to M/s. Noble Pharma,
Mirpur Azad Kashmir for cancellation of registration of above mentioned
products registered in the name of M/s. Noble Pharma, Mirpur Azad Kashmir
for not possessing the penicillin manufacturing facility.
Case No. 40: Request of M/s. Orient Traders International, Karachi for Grant of
Additional Pack Size for Already Registered Veterinary Drug.
M/s. Orient Traders International, Karachi has requested for grant of additional pack size
for their following registered imported veterinary product. Details are mentioned below;
S. Reg. Name of Drug (s) / Existing Demanded Initial Date Justification
# No. Composition. Pack. Additional of Regn.
packs. Letter
th
1. 093614 Lincomycin-40S Oral Powder 100gm 1.5Kg 25 January, “Will be more
Each gm contains:- 500gm 2019 feasible to
Lincomycin Hydrochloride 1Kg farmer with
equivalent to 10Kg respect to its
Lincomycin…..400mg 25Kg cost & usage”.
M/s. Orient Traders International, Karachi has deposited fee of Rs.5000/- and submitted
required supporting documents including;
(i) Copy of initial Registration letter.
(ii) Copy of Drug Sale License.
(iii) Copy of free sale certificate issued by Belgium authorities wherein the demanded
pack size is mentioned as ―Plastic jar of 1.5kg. Original of the same free sale
certificate is already present/submitted at the time of processing of registration
letter (issued dated 24-10-2018).
The demanded pack is not given to other firms.
Decision:- Registration Board approved the grant of additional pack size of ―1.5 Kg
plastic jar‖ to registered product Lincomycin-40S Oral Powder (Reg.No.
093614) of M/s. Orient Traders International, Karachi on same terms and
conditions.
Case No. 41: Request of M/s. Elko Organization (Pvt) Ltd., Karachi for Grant of
Additional Packs for their already Registered Veterinary Drugs.
M/s. Elko Organization (Pvt) Ltd., Karachi has applied for grant of additional pack sizes
of their following registered veterinary drugs as per details mentioned against each: -
S. Regn. Name of Drug(s)/Composition Already Demanded Initial Justification
No. No.

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MINUTES OF 289 th MEETING OF REGISTRATION BOARD

HELD ON 14 th-16th MAY, 2019

Item No. Detail of Item Pages

 Pharmaceutical Evaluation Cell (PEC) ...................... ......... 21–1118

IV. Division of Biological Evaluation & Research 1403 – 1427

A. Biological Evaluation & Research ...................................... 1456 – 1477

Drug Regulatory Authority of Pakistan

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) |1

Decision: Registration Board confirmed minutes of 288 th meeting.

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) |3

A. Dr. Amanullah Khan, Director DTL, Quetta.

2. Email of January 26, 2018

a. Biological Drugs Registration:

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) |4

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) |5

b. Manufactures Abroad Inspection Reports

B. Dr. Aslam Shah Member Registration Board, DRAP.

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) |7

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Decision: Keeping in view status of product in reference regulatory authorities,

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 12

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 13

Furthermore, the firm has also stated that:

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 14

Case No.04. Risks & Concerns Associated with Dydrogesterone.

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 15

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Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 18

A. Use of multidose Oxytocin vials in Veterinary.

B. M/s. Mustafa Brothers, Faisalabad:

Now the firm has submitted the following reply.

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 19

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 20

Pharmaceutcial Evaluation Cell (PEC)

Case No. 03 Registration applications for local manufacturing of (veterinary) drugs

Case No. 05 Registration applications of categories to be considered on priority

Case No. 06 Registration applications of import cases

Case No. 08 Miscellaneous cases

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 21

12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

Minutes of 289th Meeting of Registration Board (14-16 May, 2019) | 22

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Remarks of the EvaluatorII

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