Agenda For 288th Meeting of Registration Board

AGENDA FOR 288th MEETING OF REGISTRATION BOARD
TO BE HELD ON 14th & 15th FEBRUARY, 2019
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Item Detail of Item Pages

No.
I. Confirmation of minutes of 287th meeting of Registration Board 2
II. Division of Pharmaceutical Evaluation & Registration 3 – 1000
 Pharmaceutical Evaluation Cell (PEC) 3 – 794
 Registration-I 795-825
 Registration-II 826-827
 Import & Vet. 828-849
 Post Registration-I 850-855
 Post Registration-II 856-874

875-1000
 RRR Section
III. Division of Biological Evaluation & Research 1001-1025
IV. Division of Quality Assurance & Laboratory Testing 1026-1065
V. Any other item with permission of the Chair 1065
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4
Islamabad.
Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |1

Item No. I: Confirmation of Minutes of 287th Meeting of Registration Board.
287th meeting of Registration Board was held on 03–04th January 2019. The draft
minutes of 287th meeting of Registration Board were circulated among the members of
the meeting on 31st January 2019 for perusal/ comments (if any) within five days. In
continuation of previous minutes, an updated version of minutes was shared via email
with the members of the meeting on 04th February 2019 for their
comments/perusal/approval by 06th February 2019. In later minutes, one case of
Division of Biological Evaluation & Research (Case No.01 of Additional Agenda) was
updated and shared. Whereas, rest of minutes were same.
None of the members disagreed the draft minutes. Accordingly, fair minutes were
approved by the Chairman Registration Board and circulated to all concerned.
Submitted for confirmation of Registration Board, please.

Item No. II Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell
S.No. Detail
Case No. 01 Review of formulation
Case No. 02 Registration applications for local manufacturing of (Human) drugs
a. New cases
b. Deferred cases
Case No. 03 Registration applications of newly granted DML or New section (Human)
a. New DML
b. New/Additional section(s)
c. Remaining products of new section
d. Deferred cases
Case No. 04 Registration applications for local manufacturing of (veterinary) drugs
a. New Cases
b. Deferred Cases
Case No. 05 Registration applications of newly granted DML or New section
(Veterinary)
a. New DML /section
Case No. 06 Registration applications of categories to be considered on priority
a. Export Facilitation
b. Local manufacturing applications of priority categories defined by
Registration Board in its 257th meeting
c. Applications submitted on CTD format
d. Import applications of priority categories defined by Registration Board
in its 257th meeting
Case No. 07 Registration applications of import cases
a. New Cases (Human)
b. New Cases (Veterinary)
c. Deferred cases
i. Human
ii. Veterinary
Case No. 08 Registration applications of drugs for which stability study data is
submitted
a. New cases
b. Deferred cases
c. Onsite Verification of stability study data
d. Exemption from onsite verification of stability data
Case No. 09 Miscellaneous cases
a. Case Referred by Appellate Board
b.

Case No. 01: Review of formulation
a) Review of Quinolone- and fluoroquinolone-containing medicinal products
The case was deferred by Registration Board for further deliberation in 287th 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:
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:
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 injury. Since the use
of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these
medicines should be avoided.
The CHMP opinion will now be forwarded to the European Commission, which will issue a
final legally binding decision 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.

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.
FDA review of quinolones

FDA has started reviewing quinolones due to safety issues in 2016 and recently issued warning
and suggested changes in safety information in 2018. As per safety announcement of 20-12-2018
“A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can
increase the occurrence of rare but serious events of ruptures or tears in the main artery of the
body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm
can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for
systemic use given by mouth or through an injection.
Fluoroquinolones should not be used in patients at increased risk unless there are no other
treatment options available. People at increased risk include those with a history of blockages
or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain
genetic disorders that involve blood vessel changes, and the elderly. We are requiring that a
new warning about this risk be added to the prescribing information and patient Medication
Guide for all fluoroquinolones.
FDA has only approved following qunilones and there review is also limited to these approved
quinolones only.

Submitted before the Board for its consideration.
Evaluator PEC-II
b) Registration of Linagliptin and other cases of similar nature
The registration of “Linaglitpin” and other cases of similar nature, including registration of “Ferric
carboxymaltose” containing products, are pending before the Drug Registration Board for it
sconsideration since long. In this regard, the IPO of Pakistan furnished its opinion vide letter No. 2/AD-
patent/2006 dated 11th November, 2015. The said case was placed before Registration Board in its 278 th
meeting held on 29th to 31st January, 2018 along with following opinion of Legal Affair Division, DRAP,
“This Division is of the concerted opinion that the approach of IPO-Pakistan would create a
system of “patent linkage” i.e. practice of linking drug marketing approval to the status of the
patent of the originator’s product and not allowing the grant of marketing approval to any third
party prior to the expiration of the patent term, unless consented to by the patent owner. The
concept of patent linkage requires the generic manufacturer to prove that the drug, for which he
seeks approval, is not covered by a valid patent.
1. The assertion that drug approval cannot be granted for any drug that is likely to violate
any existing patent right is highly misleading on following grounds:-
(i) The grant of drug regulatory approval cannot, by itself amount to a patent infringement.
(ii) The existence of patent infringement cannot be assumed merely because the patentee
states so, but has to be clearly established before a court of law in accordance with the
infringement provisions mentioned under the Patents Ordinance, 2000. Such an
assessment is beyond the statutory powers of the Drug Registration Board, which
may not be able to deal with complex issues of patent scope, validity and
infringement.
2. The mere grant of a drug regulatory approval, would not, ipso facto, entail a
contravention of the Patent Ordinance or any other law. Section 30 of the Patents Ordinance,
2000 spells out the various exclusive rights of a patentee and includes the acts of “making, using,
offering for sale, selling or importing” the patented product or process as the case may be. The
grant of a drug regulatory approval on the basis that drug is safe and effective does not amount to
an act of “making, using, offering for sale, selling or importing” the patented product.
3. Section 30(5)(e) of the Patents Ordinance, 2000 clearly stipulates that the rights under the
patent shall not extend to acts, including tests, necessary for the approval of a product. It is
highly illogical to argue that when all acts leading up to the stage of drug approval are exempt

from patent infringement, the very act of approval itself amounts to an infringement. The
aforesaid section permits any drug manufacturer to experiment with any patented drug with a
view to generating data that could then be submitted to a drug control authority. The aim of this
section is to ensure that generic drugs are introduced into the market as soon as the patent expires
or is invalidated, so that consumers may benefit from this early entry of affordably priced drugs.
On the contrary, if generis manufacturers are not allowed to start with their proceedings for
regulatory approval during validity of a patent, it would indirectly amount to an extension of the
term for exclusive patent rights to the rights holder.
4. More importantly, neither is the Drug Registration Board authorized by the DRAP Act,
2012 or the Drugs Act, 1976 and rules made thereunder to make assessment of patent
infringement nor does it possess the institutional competence to make such an assessment. Under
section 18 of the IPO Act, 2012, it is only the IP Tribunal that can make such an assessment in an
infringement suit filed under the Patents Ordinance, 2000.
5. The countries that follow a system of patent linkage have a specific statutory or other
legal provision enabling such linkage. In fact, even developed countries such as the EU have, for
several policy reasons, avoided creating a patent linkage mechanism.
6. Patent linkage falls under the umbrella of ‘TRIPS Plus’ concept, i.e. higher intellectual
property standards negotiated among WTO members subsequent to TRIPS agreement. This
concept covers both those activities aimed at increasing the level of protection for right holders
beyond that which is given in the TRIPS agreement and those measures aimed at reducing the
scope or effectiveness of limitations on rights and exceptions.
7. The system of patent linkage is against public health interests as the time gap between
expiration of patent protection period of a drug and the introduction of its generic equivalent in
the market can prove disadvantageous. Grant of marketing approval does not in any manner
infringe the patent holder’s rights. The approval sought is only addressing the drug as safe and
bestowing upon it the right to carry on clinical trials, so that as soon as a valid patent expires, it is
ready to enter the market without any further delay.
8. Therefore, keeping in view the exceptions provided in law and public health interest, it is
proposed that the drug marketing approval should not be linked to the patent status of the
originator’s product by the Drug Registration Board.”
The Board in 278th meeting decided as under:

“Legal Affair Division, DRAP furnished their opinion vide letter No.F.11-1/2013 /DD(LA) dated
31.01.2018, thus Registration Board decided to forward forementioned opinion to IPO Pakistan for
their comments. Moreover, Deputy Director, Legal Affair Division, DRAP was advised to follow up
the matter with IPO Pakistan for their response.”
Accordingly IPO-Pakistan was requested by Deputy Director (Legal Affairs Division) to furnish its
comments vide letter No. F.11-1/2013/DD (LA) dated 14-03-2018. IPO-Pakistan forwarded its
views/comments vide letter No. 02/AD-I (Patents)/2008 dated 2nd October , 2018, which are reproduced
as under:
“With reference to DRAP’s letter No. F.11-1/2013/DD (LA) DATED MARCH 14, 2018, on the above
noted subject, the comments are as under:
2. The matter of use of rights by third parties, for patented products against Patent No.141311.
141044, and 141068, has already been decided by Sindh High Court, Karachi. The decision was made
after detailed arguments between the parties and in light of the Patent Ordinance, 2000. The same is
reproduced as:

“…. till the validity of Plaintiff’s Patent No. 141311, 141044, 141068, Defendants are restrained from
selling, ‘Linagliptin’ containing products or manufacturing or making formulating supplying, stocking,
importing, exporting, offering for sale, passing off, advertising or otherwise enabling others to infringe or
pass off, offer for sale or use in any form in any manner which is in infringement of the claims of the
petitioners patent, Resultantly, pending application(s) is also disposed of….”
3. The referred Section 30(5) e of the Patent Ordinance, 2000, in the DRAP letter, is an exception to
the Patent rights established under this Ordinance with certain limitation. Accordingly to Section 30(5) E,
the rights under patent shall not extend to acts, including tests, necessary for approval of a product for its
commercialization after the expiration of the patent.
4. DPAP’s Drug Registration Board has a purview with regard to the approval of a product that also
includes its commercialization, however the said exception of the Patents law shall be applied with
limitation to commercialization after the expiration of the patents.
5. The concept of Patent linkage falls under the umbrella of ‘TRIPS plus’. The developing countries
including Pakistan do not support the concept of Patent linkage.
6. Three products (Drugs) containing Linagliptin are valid patents granted to a German firm (the
applicant), BOEHRINGER INGELHEIM INTERNATIONAL GMBH by the patent Office, Karachi as
per following details:
SN Patent No. Filing date/Novelty Patent Expiry Next renewal Current patent
date date date validity status
1 141311 21/08/2002 20/08/2022 21/08/2019 Valid
2 141044 05/11/2004 04/11/2024 05/11/2018 Valid
3 141068 14/05/2009 13/05/2029 14/05/2019 Valid
7. In view of the above legal references and the decision of Singh High Court, Karachi, it is
concluded the rights of commercialization of Linagliptin and similar products, patented in Pakistan, Only
confer to the patentee(s) till the validity of their respective granted patent(s). However, third parties have
rights for acts, including tests, necessary for approval of Linagliptin etc., for its commercialization after of
the patent(s), under Section 30(5) e of patents Ordinance, 2000.”
The case is hereby presented before the Board for its consideration:
c) Tranexamic acid Capsule 500mg

The formulation of tranexamic acid 500mg capsule was deferred by Registration Board from
various meetings, now the reference has been verified from The Italian Medicine Agency
(AIFA).
The formulation is available in Italy and registered by AIFA Italy in the following strength
and dosage form. The details of product registration are as follows
 Brand Name: TRANEX 500 mg capsules
 Market Authorization number: AIC n. 022019020
 Composition
Active ingredient:
Each capsule contains Tranexamic acid……………500mg
 Marketing Authorization holder: MALESCI INSTITUTE
FARMACOBIOLOGICO SpA, Italy.
 Link for reference:
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/farmaco?farmaco=022019
(Accessed on 31-01-2019)
The following previously deferred cases of the same formulation are hereby presented before the
Board:
1. Name and address of manufacturer / M/s StandPharm (Pvt.) limited, 20 Km Ferozepur
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Tramic capsule 500mg
Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 10

Composition Each capsule contains:
Tranexamic acid…………………..500mg
Diary No. Date of R& I & fee Dy.No.17184; 05-10-2017; Rs.20,000/- (04-10-2017)
Pharmacological Group Anti- fibrinolytic agent
Type of Form Form-5
Finished Product Specification Not provided
Pack size & Demanded Price 2x 10’s & Rs. 16.5/- per cap
Approval status of product in Reference Could not be confirmed
Regulatory Authorities.
Me-too status Maxna 500mg capsule of M/s AGP (Pvt.) Limited (Reg.
# 032378)
GMP status Last GMP inspection was conducted on 19-10-2017 and
the report concludes a satisfactory level of GMP
compliance.
Remarks of the Evaluator.  The official monograph of the applied
formulation is not available in USP and BP.
 The evidence of approval in reference regulatory
authorities could not be confirmed.
Decision of previous meeting of RB Deferred for evidence of approval of applied formulation
in reference regulatory authorities/agencies which were
adopted by the Registration Board in its 275th meeting.
(M-285)
Evaluation by PEC  The evidence of approval status of this
formulation has now been verified from Italy
 The GMP inspection report stated in this
case falls within period of last 3 years
 Decision:
2. Name and address of manufacturer / M/s Islam Pharmaceuticals,7 km, Pasrur Road, Sialkot
Applicant
Brand Name +Dosage Form + Strength Tramic Capsule 500mg
Composition Each Capsule Contains:
Tranexamic Acid…500mg
Diary No. Date of R& I & fee DyNo.29174;31-08-2018; Rs. 20,000/-
Pharmacological Group Antifibrinolytics
Type of Form Form-5
Finished Product Specification Manufacturer’s Specifications
Pack size & Demanded Price 20’s: As per SRO
Me-too status Traxic 500mg Capsules of Fassgen Pharmaceuticals,
GMP status New License (letter issuance date: 29th August 2018)
Remarks of the Evaluator. Evidence of approval status of applied formulation in
reference agencies is required as provided evidence has
not been verified.
Decision of previous meeting of RB Deferred for evidence of approval status of applied
formulation i.e. “Tranexamic Acid 500mg Capsule” in
reference regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275th
meeting. (M-285)
 Decision:

3. Name and address of manufacturer / Cunnigham Pharmaceuticals (Pvt) Ltd. Plot No. 81
Applicant Sundar Industrial Estate Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Tranmic 500mg Capsule
Composition Each Capsule contains:
Tranexamic acid…. 500mg
Diary No. Date of R& I & fee Dy No.18687; 22-05-2018; Rs.20,000/-
Pharmacological Group Anti-fibrinolytics
Type of Form Form-5
Finished Product Specification Specifications
Pack size & Demanded Price 2×10’s: As per SRO
Me-too status Traxic 500mg Capsules of Fassgen Pharmaceuticals,
GMP status New License (letter Issuance Date: )
Remarks of the Evaluator. Applicant has added 5 % overage in master formulation.
Evidence of approval status of applied formulation in
reference agencies is required.
Decision of previous meeting of RB Deferred for the following:
 Justification on scientific basis for addition
of 5% overage in master formulation.
 Evidence of approval of applied formulation
in reference regulatory authorities/agencies which
were adopted by the Registration Board in its 275th
meeting. (M-284)
 Last GMP inspection report dated 31-01-
2018 concludes as “It was a new unit constructed
purposefully for the production of pharmaceuticals and
granted license by way of formulation in march 2016.
On the basis of finding of the panel it was concluded
that the firm was operating under good compliance of
cGMP on the day of inspection.
 Justification for addition of 5% overage is
NOT submitted
 Decision:
4. Name and address of manufacturer / M/s Nabi Qasim Industries Pvt Ltd, Karachi
Applicant
Brand Name +Dosage Form + Strength Transic capsule 500mg
Tranexamic acid…….500mg
Diary No. Date of R& I & fee Dy. No.1461; 29-8-2017; Rs.20,000/- (22-8-2017)
Pharmacological Group Haemostatic/Fibrinolytic
Type of Form Form-5
Finished Product Specification Innovator’s Specification
Pack size & Demanded Price 20’s, 30’s, 100’s, As per PRC
Approval status of product in Reference Could not be confirmed.
Me-too status HAEMIC-500mg by GENIX
GMP status GMP status Last inspection conducted on 03-08-2017
and 02-11-2017 reports conclude that firm is found GMP
compliant.
Remarks of the Evaluator. Approval status in RRA could not be confirmed.

adopted by the Registration Board in its 275th meeting.
(M-283)
2018 concludes as “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
compliance of cGMP requirements at the time of
inspection”
 Decision:
5. Name and address of manufacturer / M/s Danas Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Danim 500mg capsules
Tranexamic acid….500mg
Pharmacological Group Anti-fibrinolytic
Type of Form Form-5
Finished Product Specification JP
Pack size & Demanded Price 2x10’s, As per SRO
Me-too status HAEMIC-500mg by
GENIX
GMP status The firm was granted GMP certificate based on
inspection conducted on 03-10-2017.
Remarks of the Evaluator. Approval status in RRA could not be confirmed.
meeting. (M-282)
 Decision:
6. Name and address of manufacturer / M/S Epharm Laboratories, A-40, Road No.1, S.I.T.E,
Applicant Super Highway, Industrial Area, North Karachi,
Pakistan.
Brand Name +Dosage Form + Strength Ephamic-500mg Capsules
Tranexamic Acid----500mg
Diary No. Date of R& I & fee Dy.No.1180, 11-01-2017, Rs.20,000/-
Pharmacological Group Haemostatic/Fibrinolytic
Type of Form Form-5
Pack size & Demanded Price 10’s,20’s,30’s; As per SRO
Me-too status HAEMIC-500mg by
GENIX

GMP status Last Inspection report conducted on 27-04-2017 and
panel is of the view to grant GMP certificate
Remarks of the Evaluator. •Approval status of product in Reference Regulatory
Authorities not confirmed. Provided reference of
Amchafibrin-500mg Capsules by Rottapharm Spain
could not be confirm in capsule.
On asking about the clarification regarding submission of
accelerated stability studies data before production starts
the firm reply that submitted study is for small scale trail
batch however the long term accelerated and real time
stability will be submitted after production starts.
meeting (M-279)
 Last GMP inspection report 01-03-2018
concludes as “Based on above observations and
keeping in view the attitude of the management
towards the continuous improvements their current
level of compliance was noted as satisfactory.”
 Decision:
7. Name and address of manufacturer / M/s NOA HEMIS Pharmaceuticals, Plot No. 154 Sector
Applicant 23 Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Extam-D Capsule 500mg
Tranexamic acid… 500mg
Diary No. Date of R& I & fee Dy No.1159; 15-12-2015; Rs.20,000/-
Pharmacological Group Hemostatics /Antifibrinolytics
Type of Form Form-5
Finished Product Specification Manufacturer’s Specification
Pack size & Demanded Price 10’s, 20’s; As per PRC
Approval status of product in Reference Not provided, however firm submitted reference of
Regulatory Authorities. Hemostan has approved in Phillipines.
Me-too status Maxna 500mg capsules by Novartis.
GMP status Last GMP Inspection dated 14-6-17 with conclusive
remarks of cGMP compliance.
Remarks of the Evaluator.  Evidence of approval of applied formulation
in Reference Regulatory Authorities.
declared/approved by the Registration Board (M-278)
2018 confirms good compliance to GMP
 Decision:
8. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Inxamic Capsules 500mg
Composition Diary No: 24118 , 13-12-2017 , Rs: 20,000/-
Diary No. Date of R& I & fee Each capsule contains:-
Tranexamic Acid....500mg

Pharmacological Group Antifibrinolytic
Type of Form Form-5
Pack size & Demanded Price 20’s, 100’s/ As per SRO
Approval status of product in Reference Caprilon (Finland)/Hexatron (Japan) not confirmed.
Me-too status Trasamin 500mg Capsule by M/s Hilton Pharma
(Reg#009730)
GMP status 13-07-2017
Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.  Approval status of product in Reference Regulatory
Authorities not confirmed.
case falls within period of last 3 years, no latest
inspection report could be confirmed
 Decision:
9. 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 TRANXAM 500mg CAPSULES
Composition Each capsule contains:-
Tranexamic acid…500mg
Diary No. Date of R& I & fee Diary No: 26574, 29/12/2017, Rs: 20,000/-
Pharmacological Group Antifibrinolytics (Amino acids)
Type of Form Form-5
Pack size & Demanded Price 2x10’s/ As per SRO
(Reg#009730)
GMP status 05/10/2017
Grant of renewal of DML and additional sections.
Panel recommends DML renewal and additional sections
 Decision:
10. Name and address of manufacturer / M/s N.S Pharma,
Applicant Plot no. 576, 577 Sunder Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Tramic 500mg Capsule

Composition Diary No. 16186, 26/09/2017, Rs: 20,000/-
Tranexamic Acid.....500mg
Pharmacological Group Plasminogen activation inhibitor
Type of Form Form-5
Finished Product Specification Innovator’s
Pack size & Demanded Price 20’s/As Per SRO
Approval status of product in Reference Transamin of Daiichi Sanko (Japan) (Not confirmed)
(Reg#009730)
Grant of new DML
in Reference Regulatory Authorities (M-275)
 Decision:
11. Name and address of manufacturer / M/s. Lisko Pakistan,L-10-D, Block No 21, Shaheed
Applicant Rashid Minhas Road, Federal B, Industrial Area, Karachi
Brand Name +Dosage Form + Strength Tranxic Capsule 500 mg
Tranexamic acid….500 mg
Diary No. Date of R& I & fee 665, 25-04-2016, Rs. 20,000/- (25-04-2016)
Pharmacological Group Fibrinolytic /Haemostatic
Type of Form Form 5
Finished Product Specification Not provided
Pack size & Demanded Price As per SRO
Me-too status Transamin of Hilton Pharmaceuticals
GMP status 23-01-2017, Good
Remarks of the Evaluator. M/s. Lisko Pakistan,L-10-D, Block No 21, Shaheed
Rashid Minhas Road, Federal B, Industrial Area, Karachi
Decision of previous meeting of RB Deferred for the submission of evidence of approval of
applied formulation in reference regulatory
authorities/agencies which were declared/approved by
the Registration Board in its 249th meeting. (M-274)
 Last GMP inspection report dated 24-4-2018
concludes “Based on current inspection, documents
reviewed it was noted that firm is currently working
under satisfactory level of cGMP compliance.
 (Show cause notice revoked on 27-04-
2018)”
 Decision:
12. Name and address of manufacturer / M/s. Wellborne PharmaChem and Biologicals,

Applicant Plot No. 51/1,52/2, Phase I-II, Industrial Estate
Hattar
Brand Name +Dosage Form + Strength Transec Capsule 500mg
Composition Each capsule contain:
Diary No. Date of R& I & fee Dy. No. 153, 16-06-2015 , Rs.20,000/- (16-06-2015)
Pharmacological Group Anti-fibrinolytic
Type of Form Form-5
Finished Product Specification Manufacturer
Me-too status Transamin of Hilton Pharmaceuticals
GMP status Last inspection conducted on 27-02-2017“Strictly
following the GMP compliance.”
Remarks of the Evaluator.  Firm have not applied on prescribed application
format as per Schedule A of Drugs (Licensing,
Registering, and Advertising) Rules, 1976.
Decision of previous meeting of RB Deferred for the following reasons:
Submission of evidence of approval of applied
formulation in reference regulatory
the Registration Board in its
249th meeting.
Submission of applied formulation on prescribed
application format as per Schedule A
of Drugs (Licensing, Registering, and Advertising)
Rules, 1976. (M-274)
concludes “The firm was inspected to ascertain and
assess the manufacturing testing facilities and to
evaluate the GMP compliance. During the inspection,
certain suggestions/improvements were made regarding
the production, quality control and other facilities. The
management of the firm agreed to comply with these
suggestions at their earliest and look committed to
bring the necessary improvements. The firm was also in
the process of installation a 2D bar code printer to
comply with the DRAP guidelines.
As per available production, quality control facilities
and technical/qualified personnel employed, it is
concluded the firm M/s Wellborn Pharmachem and
Biologiclas Industrial Estate Hattar is operating under
good level of cGMP.”
 Firm has submitted new form 5
 Decision:
13. 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 Tranza 500mg Capsule
Composition Diary No: 13026, 22/08/2017, Rs: 20,000/-
Tranexamic Acid.....500mg
Pharmacological Group Plasminogen activation inhibitor
Type of Form Form 5
(Reg#009730)
GMP status New License (Inspection Date: 10th June 2017)
by reference regulatory authorities. (M-274)
concludes as “Keeping in view the stated conditions
and attitude of the firm towards better compliance, their
current GMP is rated as GOOD”
 Decision:
14. Name and address of manufacturer / PALPEX PHARMACEUTICALS (Pvt) Ltd.
Applicant Plot # FD-46-A8 Korangi Creek Industrial Park Karachi.
Brand Name +Dosage Form + Strength TRANSPAL Capsule 500 mg
Composition Each capsule contains
Tranexamic Acid ....500 mg
Diary No. Date of R& I & fee Dy. No. 5706, Dated 12/06/2017,
Rs 20,000/= Dated 12/06/2017,
Pharmacological Group Anti – Fibrinolytic
Type of Form Form – 5
Finished Product Specification USP
Pack size & Demanded Price Pack Size: 1×10’s Price: As per S.R.O
Approval status of product in Reference Cannot be confirmed
(Reg#009730)
GMP status New License
Remarks of the Evaluator.  The firm has claimed USP specifications and the
product is not present in USP/BP. However, the
product is present in JP.
 Approval status of the product in reference regulatory
authorities cannot be confirmed.
Decision of previous meeting of RB Deferred for evidence of approval in reference regulatory
authorities. (M-272)
 GMP certificate issued dated 8-5-2018
 Decision:
15. Name and address of manufacturer / M/s Astellas Pharmaceutical (Pvt) Ltd.
Applicant Industrial Estate, Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Asmic 500mg capsules
Composition Diary No: 4378, 30/05/2017, Rs: 20,000/-
Diary No. Date of R& I & fee Each capsule contains:
Tranexamic acid…500mg
Pharmacological Group Antifibrinolytic
Type of Form Form-5

Finished Product Specification Manufacturer‘s Specifications
Pack size & Demanded Price 20’s/ As Per SRO
(Reg#009730)
GMP status 31-03-17; Inspection of Additional Sections.
Panel recommends grant of additional sections
by reference regulatory authorities. (M-272)
concludes as Over all the firm was operating under
satisfactory level of GMP."
 Decision:
16. Name and address of manufacturer / Wimits Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Xamic 500mg capsules
Composition Dy No:51; 23-12-2013; Rs.20,000/-
Diary No. Date of R& I & fee Each capsule contains
Pharmacological Group Antifibrinolytics/Antiplasmenic agent
Type of Form Form-5
Finished Product Specification Manufacturer’s Specification
Pack size & Demanded Price 20’s As per SRO
Approval status of product in Reference USA
Me-too status Transamin by Himont
GMP status Last Inspection report 10-10-2016 firm had maintained
conformance to GMP compliance in the manufacturing and
quality control operations.
Remarks of the Evaluator.  Fee challan photocopy is attached
 International availability in reference
regulatory authorities is not confirmed.
 Firm has claimed Mfg Specs while the
product is present in Japanese Pharmacopeia.
Decision of previous meeting of RB Deferred for evidence of approval status of formulation
in the reference regulatory authorities. (M-271)
concludes as “The panel of inspectors was of the
opinion, that the firm M/s Wimits Pharmaceuticals
Lahore had maintained satisfactory conformance
to GMP Compliance in the manufacturing and
Quality control operations on the day of
inspection.”GMP Certificate issued on 10-12-
2018.."
 Decision:
17. Name and address of manufacturer / M/s Rotex pharma, Islamabad
Applicant
Brand Name +Dosage Form + Strength Voxin 500mg Capsule
Composition 34, 7-2-2011, Rs 8000, Rs 12000
Tranexamic acid……500mg
Pharmacological Group Antifibrinolytic hemostatic
Type of Form Form-5
Pack size & Demanded Price 20’s. 30’s As per SRO
Approval status of product in Reference Not provided
Me-too status Maxna capsules 500mg by AGP
GMP status Last Inspection report 17-3-2017
The panel concluded that the company is following GMP
guidelines.
Remarks of the Evaluator.  Fee challan photocopy is attached
 International availability in RRA cannot be
confirmed.
 The firm has claimed manufacturer’s specs
and has not submitted the data as per requirement
of the decision made in 267th meeting of DRB.
Decision of previous meeting of RB Deferred for evidence of approval in Reference
Regulatory Authorities. (M-270)
 Decision:
18. Name and address of manufacturer / M/s. Martin Dow Limited, Plot No. 37 Sector 19,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Tivita 500mg Capsule
Composition Dy No. 1068, 30-06-2014, Rs.20000/-

Tranexamic acid(USP) …500mg
Pharmacological Group Hemostatics, (Amino acid antifibrinolytics)(
B02AA02)
Type of Form Form-5
Finished Product Specification Mfg Specs
Pack size & Demanded Price 20’s, 30’s, 30’s (alu/alu blister); As per brand
leader’s price.
Approval status of product in Reference Not provided however firm submitted reference of
Regulatory Authorities. Hemostan has approved in Phillipines.
Me-too status Maxna 500mg capsules by Novartis.
GMP status Last GMP Inspection of M/s Martin Dow conducted
on 18-03-2016 with conclusive remarks of
satisfactory level of cGMP compliance & overall it
is rated as good.
Certificate of cGMP issued to the firm based on
inspection conducted on 18-03-16 & is valid for a
period of one year from the date of issue.
Remarks of the Evaluator. i. Firm has claimed Mfg Specs but has not

submitted the data as required by decision
taken in 267th R.B meeting, & the applied
formulation does not exist in available USP
& B.P.
ii. Firm has capsule general section.
Decision of previous meeting of RB Deferred for:

I. Evidence of approval, of applied formulation, by
reference regulatory authorities as decided in
249th meeting of Registration Board as stated
reference is incorrect
II. Submission of GMP inspection report conducted
within the period of last one year. (M-269)
concludes as “After reviewing their QA System, QC
& Manufacturing, relevant documents, utilities and
personnel capacity the current GMP are rated as
GOOD.”
 Decision:
19. Name and address of manufacturer / M/s Gulf Pharmaceuticals Rawat.
Applicant
Brand Name +Dosage Form + Strength Exacyl-500 Capsules
Tranexamic Acid……500mg
Diary No. Date of R& I & fee 11-07-2012 Rs.8000/= (Photocopy attached) 30-10-
2014 Rs.12,000/= Dy.No.6945
Pharmacological Group (Haemostatic)
Type of Form Form 5
Finished Product Specification
Pack size & Demanded Price 2x10’s As per SRO
Approval status of product in Reference Not Provided
Me-too status Transamin of Hilton pharma
GMP status Inspection conducted on 18-05-2016 showed that the
firm is found complying GMP as of today
Remarks of the Evaluator. RRA not provided
Firm claims manufacturer’s specs
Decision of previous meeting of RB Deferred for evidence of approval by reference
regulatory authorities. (M-268)
 Decision:
20. Name and address of manufacturer / M/s Bio Labs (Pvt) Ltd, Islamabad
Applicant
Brand Name +Dosage Form + Strength Tranex 500mg Capsules
Tranexamic Acid .……..500mg
Diary No. Date of R& I & fee Dy.No.2695 Rs.8000/= 31-05-2012
Rs.12,000/= 28-07-2014
Pharmacological Group (Antihaemorrhagics/ Antihaemophillic Preparations)
Type of Form Form 5
Pack size & Demanded Price 1x10‘s, 2x10‘s, 10x10‘s: As Per SRO
Approval status of product in Reference International Availability not provided.
Me-too status Aneptil by Alina
GMP status Last inspection report of 16-8-2016 submitted with
compliance remarks.
Remarks of the Evaluator.
Decision of previous meeting of RB Deferred for evidence of approval of applied dosage form
& strength (formulation) by reference regulatory
authorities (M-267)
 GMP certificate issued on the basis of
inspection dated 5th and 6th December 2017.
 Decision:
21. Name and address of manufacturer / M/s Swiss PharmaceuticalKarachi
Applicant
Brand Name +Dosage Form + Strength Utramax 500mg Capsule

Tranexamic Acid…..500 mg
Diary No. Date of R& I & fee Duplicate 28-7-2010, Dy.No.1449
Rs.8000/- (Photocopy) + Rs.12,000/-12-11-2014
Pharmacological Group (Anti hemorrhagic)
Type of Form Form-5
Pack size & Demanded Price 20’s Rs.250/-
Approval status of product in Reference Cyklokapron in USA
Me-too status Transamin by Hilton Pharma
GMP status Last inspection report 19-04-2016 Shows acceptable
level of GMP compliance.
Remarks of the Evaluator. Reference Authority status could not be confirmed
Firm has claimed Mfg. Specs while the product is
present in Japanese Pharmacopeia
regulatory authorities (M-266)
2018 concludes as GMP compliance level is rated as
GOOD.”
 Decision:
22. Name and address of manufacturer / M/s. Tayyab Laboratories, Islamabad
Applicant
Brand Name +Dosage Form + Strength TRANEX 500 MG CAPSULE
Composition Each Capsule Contains

Tranexamic Acid BP………500 MG
Diary No. Date of R& I & fee 16-12-2016
Dy. No 2976 Rs. 20000/-
Pharmacological Group (Fibrinolytic)
Type of Form Form5
Finished Product Specification (Manufacturing Specs)
Pack size & Demanded Price As per SRO: 100s
Approval status of product in Reference
Me-too status Transamire by hiton pharma
GMP status
Evaluation by PEC  The evidence of approval status of this formulation
has now been verified from Italy
 Last GMP inspection report could not be confirmed
 Decision:
23. Name and address of manufacturer / M/s. Weather Folds Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Tranxam 500mg Capsule
Tranexamic acid.. 500mg
Diary No. Date of R& I & fee 29-12-2010
Dy No. 41
Rs.8000/
Rs.12000/
17-11-2014
Pharmacological Group (Antifibrinolytic)
Type of Form Form 5
Finished Product Specification Mfg Specs
Pack size & Demanded Price as per SRO
Me-too status RANEX-Ambrosia pharmaceuticals
GMP status Inspection report dated 04-08-2016
Grant Renewal of DML
Remarks of the Evaluator. Evidence of approval status in reference regulatory
authorities in capsule dosage form is required.
Decision of previous meeting of RB Deferred for evidence of approval status in reference
regulatory authorities in capsule dosage form. (M-263)
concludes as Overall the firm was GMP Compliant as
per DRAP Guidelines
 Decision:
24. Name and address of manufacturer / M/s Jaens Pharmaceutical Industries (Pvt) Ltd.,
Applicant Sheikhupura
Brand Name +Dosage Form + Strength Xamic Capsule
Tranexamic Acid : 500mg.
Diary No. Date of R& I & fee Dy No. 633 fee Rs.20,000/
Pharmacological Group Haemostatic / Fibrinolytic
Type of Form Form 5
Finished Product Specification MFG Specs
Pack size & Demanded Price Rs.20,000/ 1x20‘s blister As fixed by Govt.
Me-too status Transamin Capsule By M/s Hilton
GMP status Inspection Date 28-09-2016 GMP status: Submit
compliance within 15 days time period, so that
follow up inspection could be carried out.
Decision of previous meeting of RB Deferred for evidence of approval of applied dosage
form & strength in reference regulatory authorities (M-
263)
2017 concludes as Based on the areas inspected, the
people met and considering the findings of
inspection M/s Jaens Pharmaceuticals (pvt.) ltd., 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.”
 Decision:
d) Propyphenazone 175 mg / Caffeine Anhydrous 25 mg sugar coated tablet

The formulation of Propyphenazone 175 mg / Caffeine Anhydrous 25 mg sugar coated tablet
was deferred by Registration Board from various meetings, now the reference has been verified
from Spanish Agency for Medicines and Health Products Spain.
The formulation is available in Spain and registered by Spanish Agency for Medicines and
Health Products in the following strength and dosage form. The details of product registration
are as follows
 Brand Name: OPTALIDON DRAGEES*
 Market Authorization number: 3941
 Composition (This formulation is sugar coated)
Active ingredient:
Propyphenazone ……………175mg
Caffeine anhydrous………….25mg
 Marketing Authorization holder: PERRIGO SPAIN SA.
 Link for reference:
https://cima.aemps.es/cima/pdfs/ft/3941/FT_3941.pdf (Accessed on 08-02-2019)
*. DRAGEES is a dosage form previously used to describe coated tablets in Europe. Now this
term has been re-mapped by EMA (https://www.ema.europa.eu/documents/other/eudravigilance-
extended-medicinal-product-dictionary-xevmpd-pharmaceutical-dose-forms_en.xls Accessed on
08-02-2019)
The following previously deferred cases of the same formulation are hereby presented before the
Board:
25. Name and address of manufacturer / M/s MBL Pharma, B-77-A, H.I.T.E., Hub Baluchistan
Applicant

Brand Name +Dosage Form + Strength Andinole Tablet
Composition Each sugar coated tablet contains:
Propyphenazone …..175 mg
Caffeine anhydrous…25mg
Diary No. Date of R& I & fee Dy No. 1030: 18-5-2016PKR 20,000/-: 18-5-2016
Pharmacological Group (Analgesics)
Type of Form Form 5
Finished Product Specification Firm has claimed in house specification
Pack size & Demanded Price 200‘s: Rs. 160/-
Me-too status Romtolido tablets by Regent Pharma
GMP status Last inspection report dated 22-5-2017 confirms
good
compliance to GMP
Remarks of the Evaluator. Evidence of approval in reference regulatory
authorities
could not be confirmed
formulation has now been verified from Spain
 Decision:
Case No. 02: Registration applications for local manufacturing of (Human) drugs
a. New cases
Evaluator PEC-II
26. Name and address of M/s Welmed Pharmaceuticals Industries (Pvt.) Ltd., Plot No.
manufacturer / Applicant 108, R-02, Industrial Estate Gadoon, Dist. Swabi.
Brand Name +Dosage Form + Linzomed tablet 600mg
Strength Other proposed brand names:
Linozid
Lizomed
Zizolid
Composition Each film coated tablet contains:
Linezolid….……600mg
Pharmacological Group Oxazolidinone anti-infective
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 1x10’s; As per DRAP policy
Approval status of product in Zyvox 600mg tablet(USFDA approved)
Reference Regulatory
Authorities
Me-too status (with strength and Linzol tablet 600mg of M/s Regal Pharmaceuticals
dosage form)
GMP status Firm has submitted copy of GMP inspection report
conducted on 12-12-2018, concluding as under:
“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.”
Remarks of the Evaluator
Decision:
Brand Name +Dosage Form + Welfenac tablet 100mg
Aceclofenac
Welfin
Aceclofenac…. ……100mg
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specifications Manufacturer’s specification
Pack size & Demanded Price 1x10’s; As per SRO
Approval status of product in Preservex 100mg tablets (MHRA approved)
Authorities
Me-too status (with strength and Anac tablet 100mg of M/s Ankaz Pharmaceuticals
dosage form)
“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:
Brand Name +Dosage Form + Montimed tablet 10mg
Montimedwin
Telukast
Montelukast as sodium…. ……10mg
Pharmacological Group Leukotriene receptor antagonist
Type of Form Form-5
Finished product Specifications BP
Pack size & Demanded Price 1x10’s; As per DRAP policy
Approval status of product in Singulair (USFDA approved)
Authorities
Me-too status (with strength and Montewns tablet 10mg of M/s Wnsfeild Pharmaceutical
dosage form)
GMP status Firm has submitted copy of GMP inspection report conducted on
12-12-2018, concluding as under:
“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:
29. Name and address of "M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
manufacturer / Applicant Road, Islamabad"
Brand Name +Dosage Form + Xalfin 200mg Tablets
Strength
Composition "Each Film Coated Tablet Contains:
Rifaximin ……200mg"
Diary No. Date of R& I & fee Dy. No 1622 dated 11-01-2018 Rs. 20,000 Dated 11-01-2018
Pharmacological Group Intestinal anti-infective
Type of Form Form-5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 10’s As recommended by PRC
Approval status of product in Approved by MHRA of UK
Authorities.
Me-too status Nixaf 200mg Tablet of M/s Sami Karachi (Reg.#076310)
GMP status Copy of GMP certificate submitted issue don the basis of
inspection conducted on 05 & 06-12-2017
Remarks of the Evaluator2
Decision:
30. Name and address of "M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
manufacturer / Applicant Road, Islamabad"
Brand Name +Dosage Form + Xalfin 550mg Tablets
Strength
Rifaximin…550mg"
Diary No. Date of R& I & fee Dy. No 1623 dated 11-01-2018 Rs. 20,000 Dated 11-01-2018
Pharmacological Group Intestinal anti-infective
Type of Form Form-5
Pack size & Demanded Price 10’s As recommended by PRC
Authorities.
Me-too status Rixago 550mg Tablet by M/s OBS Pharma Karachi
(Reg#081073)
GMP status Copy of GMP certificate submitted issue don the basis of
inspection conducted on 05 & 06-12-2017
Decision:
31. Name and address of M/s Pharmedic Lab., 15-16 Km, Multan Road Lahore.
manufacturer / Applicant
Brand Name +Dosage Form + Valpine tablet
Strength
Amlodipine (as besylate) …… 10mg
Valsartan (as potassium)…….. 160mg
Diary No. Date of R& I & fee Dy. No. 2259; 08-12-2016; Rs.20,000/- (08-12-2016)
Pharmacological Group Anti-hypertensive
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 7’s; Rs.140/-, 14’s; Rs. 250/-, 28’s; Rs. 500/-

Authorities.
Me-too status Amlodine Tablet 10/160 of M/s Jupiter Pharma (Reg.#081933)
GMP status Copy of cGMP panel inspection, dated 07-08-20198, 04-09-2018
& 22-11-2018 recommending as under:
“The observations noted during the inspections were discussed at
length with the firm’s management and it was advised to rectify
the shortcomings and submit compliance report.”
Remarks of the Evaluator.  Master formulation includes “Valsartan as Potassium”
whereas reference product approved by USFDA & MHRA
contains Valsartan in pure form only. Clarification is required
in this regard.
 Upon communication of above observations firm has
submitted revised master formulation containing Valsartan as
base form only.
Decision:
Brand Name +Dosage Form + Valpine 5/80 tablet
Strength
Type of Form Form 5
Authorities.
in this regard.
base form only.
Decision:
Brand Name +Dosage Form + Valpine 5/160 tablet
Strength
Type of Form Form 5
Authorities.
in this regard.
base form only.
Decision:
Brand Name +Dosage Form + Stevia tablet 100mg
Strength
Sitagliptin (as phosphate monohydrate) …… 100mg
Pharmacological Group Anti-diabetic
Type of Form Form 5

Authorities.
Me-too status Duvel 100mg Tablet of M/s Martin Dow Ltd. Karachi
(Reg.#079616)
Decision:
Brand Name +Dosage Form + Stevia-M tablet 50/500mg
Strength
Metformin hydrochloride …… 500mg
Type of Form Form 5

Agenda for 288 Meeting of Registration Board (14-15 February, 2019)
th
| 29
Finished product Specification Manufacturer specification
Approval status of product in Approved by USFDA
Authorities.
Me-too status Treviamet 50mg/500mg Tablets by M/s GETZ Pharma Pakistan
(Reg# 055443)
Remarks of the Evaluator.  In contrary to approved by the reference agencies/authorities
wherein the applied formulation is contains Metformin
hydrochloride equal to 500mg, while you have applied for
Metformin as hydrochloride equal to 500mg of Metformin.
Clarification is required in this regard.
submitted revised master formulation containing Metformin
hydrochloride equal to 500mg.
Decision:
Strength
Type of Form Form 5

Authorities.
Me-too status Duvel 25mg Tablet by M/s Martin Dow Ltd. Karachi (Reg#
079614)
Decision:
Strength
Type of Form Form 5
Approval status of product in Not verifiable
Authorities.
Me-too status Tagipmet 25/500 Tabletsby M/s. Highnoon Laboratories, (Reg#
071231)
Remarks of the Evaluator.  Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved
by the Registration Board shall be submitted.
Decision:
Strength
Type of Form Form 5

Authorities.
Me-too status Tagipmet 50/1000 Tablets by M//s. Highnoon Laboratories,
(Reg.# 059787)
Remarks of the Evaluator.  In contrary to approved by the reference agencies/authorities
wherein the applied formulation is contains Metformin
hydrochloride equal to 1000mg, while you have applied for
Metformin as hydrochloride equal to 1000mg of Metformin.
Clarification is required in this regard.
submitted revised master formulation containing Metformin
hydrochloride equal to 1000mg.
Decision:
Strength
Type of Form Form 5

Authorities.
Me-too status Duvel 50mg Tablet by M/s Martin Dow Ltd. Karachi (Reg#
079615)
Decision:
Brand Name +Dosage Form + Moflox tablet 400mg
Strength
Moxifloxacin (as hydrochloride) …… 400mg
Pharmacological Group Antibiotic
Type of Form Form 5

Finished product Specification Manufacturer’s specification
Pack size & Demanded Price 1 x 5’s; Rs. 475/-
Authorities.
Me-too status Navelox Tablets 400mg by M/s Navegal Laboratories
(R#068237)
Decision:
Evaluator PEC-III
41. Name and address
of M/s Nortech Pharmaceuticals, Plot No. 203, Sihala Industrial
manufacturer / Applicant Triangle, Kahuta Road, Islamabad`
Contract Manufactured by:
M/s Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23,
Industrial Estate, Kahuta road, Model Town, Islamabad.
Brand Name +Dosage Form + Essonor 40mg Injection
Strength
Composition Each vial Contains:
Esomeprazole (as sodium)…40mg
Diary No. Date of R& I & fee Dy.No 21383 dated 17-11-2017
Rs. 50,000/- Dated 17-11-2017
Pharmacological Group PPI
Type of Form Form 5
Pack size & demanded price 1’s: As per SRO
Approval status of product in Nexium I.V. 40 mg Powder for solution for injection/infusion by
Reference Regulatory Authorities. Astrazaneca (MHRA Approved)
Me-too status Nexum Injection by Getz
GMP status Vision Pharmaceuticals was issued GMP certificate based on
inspection dated 26-01-2018
Remarks of the Evaluator3.  Firm has initially applied for contract manufacturing
from Bio-labs, but later firm has requested to change the
manufacturer from M/s Bio-labs to M/s Vision Pharma
 M/s Nortech pharma has 6 approved sections and have
no product already approved for contract manufacturing.
Decision:
42. Name and address of M/s Nortech Pharmaceuticals, Plot No. 203, Sihala Industrial
manufacturer / Applicant Triangle, Kahuta Road, Islamabad
M/s Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23,
Industrial Estate, Kahuta road, Model Town, Islamabad.
Brand Name +Dosage Form + Omepranor 40mg Injection
Strength
Omeprazole (as sodium)…40mg
Rs. 50,000/- Dated 17-11-2017
Type of Form Form 5
Approval status of product in Omeprazole 40 mg Powder for Solution for Infusion by Sandoz
Reference Regulatory Authorities. (MHRA Approved)
Me-too status Risek Injection by Getz
Remarks of the Evaluator3.  Firm has initially applied for contract manufacturing
from Bio-labs, but later firm has requested to change the
manufacturer from M/s Bio-labs to M/s Vision Pharma
 M/s Nortech pharma has 6 approved sections and have
no product already approved for contract manufacturing.
Decision:
43. Name and address of M/s Caraway Pharmaceuticals, Plot No. 12, Street # N-3, Rawat
manufacturer / Applicant Industrial Zone (RCCI), Rawat, Islamabad.
M/s Bio-Labs (Pvt.) Ltd., Plot No. 145, Industrial Triangle,
Kahuta road, Islamabad.
Brand Name +Dosage Form + Ompro 40mg Injection
Strength
Omeprazole (as sodium)…..40mg
Rs. 50,000/- Dated 12-11-2017
Type of Form Form 5
GMP status Bio-labs pharma was issued GMP certificate based on inspection
dated 5th and 6th December 2017
Remarks of the Evaluator3.  M/s Caraway pharma has 9 approved sections.
 Registration Board in its 286th meeting on the basis of
panel inspection report for capacity assessment decided NOT to
allow the contract manufacturing in Dry Vial (General) section
till capacity assessment and Dry vial (Cephalosporin) till capacity
enhancement however the Board allowed contract manufacturing
for Infusion (nonantibiotic and antibiotic) and Ampoule (General)
section.
Decision:
44. Name and address of M/s Caraway Pharmaceuticals, Plot No. 12, Street # N-3, Rawat
manufacturer / Applicant Industrial Zone (RCCI), Rawat, Islamabad.
Brand Name +Dosage Form + Vogue 40mg Injection
Strength
Esomeprazole (as sodium)…40mg
Rs. 50,000/- Dated 12-11-2017
Type of Form Form 5
3
Remarks of the Evaluator .  M/s Caraway pharma has 9 approved sections.
section.
Decision:
45. Name and address of M/s Jupiter Pharma, Plot No. 25, Street # S-6, National
manufacturer / Applicant Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Julac Injection
Strength
Composition Each 1ml ampoule contains:
Ketorolac Tromethamine ………….30mg
Rs. 50,000/- Dated 17-11-2017
Type of Form Form 5
Approval status of product in Ketorolac Injection by Hospira
Reference Regulatory Authorities. (USFDA Approved)
Me-too status Toradol Injection
3
Remarks of the Evaluator .  M/s Jupiter Pharma has 3 approved sections and have
no product already registered for contract manufacturing.
section.
Decision:
Brand Name +Dosage Form + Jumep Injection
Strength
Composition Each vial contain:
Omeprazole sodium eq. to Omeprazole ………..40mg
Rs. 50,000/- Dated 17-11-2017
Type of Form Form 5
Remarks of the Evaluator3.  M/s Jupiter Pharma has 3 approved sections and have
section.
Decision:
Brand Name +Dosage Form + Esojup Injection
Strength
Composition Each vial contain:
Esomeprazole (as sodium)………..40mg
Rs. 50,000/- Dated 17-11-2017
Type of Form Form 5
section.
Decision:
Brand Name +Dosage Form + Julevo Infusion 500mg /100ml
Strength
Composition Each 100 ml contains:
Levofloxacin Hemihydrate eq. to levofloxacin………..500mg
Rs. 50,000/- Dated 17-11-2017
Type of Form Form 5
Pack size & demanded price As per SRO
Approval status of product in Levofloxacin 5 mg/ml Solution for Infusion by Hospira
Me-too status Livaquin Injection by Barret Hodgson
3
section.
Decision:
Brand Name +Dosage Form + Ostoblock Ampoule
Strength
Composition Each 1ml contains:
Cholecalciferol ……5mg
Rs. 50,000/- Dated 17-11-2017
Pharmacological Group Vitamin D3 analogue
Type of Form Form 5
Approval status of product in Vitamin D3 Good 200,000 IU / 1 ml, oral solution in
Reference Regulatory Authorities. ampoule and Vitamin D3 Good 200,000 IU / 1 ml, solution
for injection IM in ampoule by Bouchara-Recordati. ANSM
Approved
Me-too status ORA-D3 Injection by Ameer & Adnan Pharmaceuticals
3
section.
Decision:
Brand Name +Dosage Form + Jucip Infusion
Strength
Ciprofloxacin lactate eq. to Ciprofloxacin……………200mg
Rs. 50,000/- Dated 17-11-2017
Type of Form Form 5
Approval status of product in Ciprofloxacin 2 mg/ml solution for infusion by Hospira
Me-too status Novidat Injection by Sami
3
section.
Decision:
Brand Name +Dosage Form + Neurojup Injection
Strength
Composition Each ampoule (Iml) contains:
Mecobalamin……..500mcg
Rs. 50,000/- Dated 17-11-2017
Pharmacological Group Vitamin B12
Type of Form Form 5
Pack size & demanded price As per SRO
Approval status of product in PMDA Japan Approved
Reference Regulatory Authorities.
Me-too status Flench inj. By Tabros Pharma
3
section.
Decision:
Brand Name +Dosage Form + Jurose Injection
Strength
Iron sucrose eq. to elemental iron .………….100mg
Rs. 50,000/- Dated 17-11-2017
Pharmacological Group Anti- anaemic
Type of Form Form 5
Finished Product Specification BP Specs
Pack size & demanded price 5ml x 5’s: As per SRO
Approval status of product in Venofer Injection
Reference Regulatory Authorities. (TGA Australia Approved)
Me-too status Irofit Injection by Zafa
section.
Decision:
Evaluator PEC-IV
53. Name and address of manufacturer / M/s Brookes Pharma Pvt Ltd.
Applicant 58 & 59, Sector 15, Korangi Industrial Area, Karach
Brand Name +Dosage Form + Strength Gen-Zithro 250mg Tablet
Composition Each Film Coated Tablet Contains:
Azithromycin………250mg
Diary No. Date of R& I & fee Dy.No;24930 18-12-2017 Rs. 20,000-(18-12-2017)
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form 5
Finished product Specifications USP
Pack size & Demanded Price 6’s, ; As per SRO
Approval status of product in Azithromycin tablet of (MHRA approved)
Reference Regulatory Authorities
Me-too status (with strength and Azic 250mg Tablet by M/s NabiQasim
dosage form)
GMP status Last GMP inspection conducted 11-10-2017 & 16-10-
2017and the report concludes that firm was considered
to be operating at Satisfactory level of compliance
with GMPguidelines
Decision:
Applicant 58 & 59, Sector 15, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Gen-Zithro 500mg Tablet
Azithromycin………500mg
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form 5
Pack size & Demanded Price 6’s, ; As per SRO
Approval status of product in Azithromycin tablet of (MHRA approved)
Me-too status (with strength and Azic 500mg Tablet by M/s NabiQasim
dosage form)
GMP status Last GMP inspection conducted 11-10-2017 & 16-10-
2017and the report concludes that firm was considered
to be operating at Satisfactory level of compliance
with GMPguidelines
Decision:
55. Name and address of manufacturer / M/s Welwrd Pharmaceuticals.
Applicant Plot # 3, Block A, Phase I-II, Industrial Estate Hattar,
KPK
Brand Name +Dosage Form + Strength Toward 25mg Tablet
Topiramate (USP)…25mg
Diary No. Date of R& I & fee Dy.No 5337 dated 14-02-2018 Rs. 20,000/- Dated 13-
02-2018
Pharmacological Group Anti Psychotic
Type of Form Form 5
Approval status of product in TOPAMAX tablet of (USFDA approved)
Me-too status (with strength and Neutop 25mg Tablet M/s Nabiqasim
dosage form)
GMP status The last GMP inspection conducted on 14-06-2017
and report concludes that overall the firm is GMP
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Toward 50mg Tablet
Topiramate (USP)…50mg
02-2018
Pharmacological Group Anti Psychotic
Type of Form Form 5
Approval status of product in TOPAMAX tablet of (USFDA approved)
Me-too status (with strength and Neutop 50mg Tablet M/s Nabiqasim
dosage form)
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Nebiwrd 2.5mg Tablet
Composition Each uncoated tablet contains:
Nebivolol as hydrochloride (In-house)…2.5mg
02-2018
Pharmacological Group Anti Hypertensive
Type of Form Form 5
Finished product Specifications Manufacture specification
Approval status of product in BYSTOLIC tablet of (USFDA approved)
Me-too status (with strength and Nibovo Tablets 2.5mgM/s. Dyson Research
dosage form) Laboratories
compliant
Decision:
58. Name and address of manufacturer / M/s Welwrd Pharmaceuticals. Plot # 3, Block A, Phase
Applicant I-II, Industrial Estate Hattar, KPK
Brand Name +Dosage Form + Strength Nebiwrd 5mg Tablet
Nebivolol as hydrochloride (In-house)…5mg
02-2018
Pharmacological Group Anti Hypertensive
Type of Form Form 5
Approval status of product in BYSTOLIC tablet of (USFDA approved)
Me-too status (with strength and Nibovo Tablets 5mgM/s. Dyson Research
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Ivowel 5mg Tablets
Ivabradine (as HCl)…5mg
02-2018
Pharmacological Group Antiangina
Type of Form Form 5
Approval status of product in Ivabradine tablet of (MHRA approved)
Me-too status (with strength and Sivab tablets of M/s Getz
dosage form)
compliant
Decision:

KPK
Brand Name +Dosage Form + Strength Ivowel 7.5mg Tablets
Ivabradine (as HCl)…7.5mg
02-2018
Pharmacological Group Antiangina
Type of Form Form 5
Approval status of product in Ivabradine tablet of (MHRA approved)
Me-too status (with strength and Sivab tablets of M/s Getz
dosage form)
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Etrowrd 60mg Tablet
Etoricoxib (In-house)…60mg
02-2018
Type of Form Form 5
Approval status of product in ACOXXEL 60 MG of (MHRA approved)
Me-too status (with strength and Oraxib 60mg Table M/s. Atco Lab
dosage form)
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Riswrd 1mg Tablet
Risperidone (USP)…1mg
02-2018
Pharmacological Group Sedative
Type of Form Form 5
Approval status of product in RISPERDAL 1MG of (MHRA approved)
Me-too status (with strength and Rislet 1mg Tablet M/s. High-Q Pharmaceuticals
dosage form)
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Riswrd 2mg Tablet
Risperidone (USP)…2mg
02-2018
Type of Form Form 5
dosage form)
compliant
Decision:
KPK
Brand Name +Dosage Form + Strength Doxwrd 400mg Tablets
Doxofylline (In-House)…400mg
02-2018
Pharmacological Group Anti-Asthamatic
Type of Form Form 5
Finished product Specifications Manufacturer specification
Approval status of product in Ansimar 400 mg tabletABC International Pharma Srl
Reference Regulatory Authorities Ivrea, Italy
Me-too status (with strength and Unifyline 400mg Tablets M/s. Platinum
dosage form) Pharmaceuticals
compliant
Decision:
65. Name and address of manufacturer / M/s Akhai Pharmaceuticals Pvt Ltd.
Applicant Plot # A-248 & A-256 to A-259, H.I.T.E. Lasbela
Balochistan, Pakistan
Brand Name +Dosage Form + Strength Sitag Tablet

Sitagliptin Phosphate Monohydrate Eq. to
Sitagliptin…50mg
02-2018
Pharmacological Group Antihyperglycemic
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s: As per SRO
Approval status of product in Januvia tablets of (FDA approved)
Me-too status (with strength and A-Glip Tablets of M/s Atco Labs
dosage form)
GMP status GMP Certificate issued based on inspection dated 15
March,2018. GMP inspection report dated 15-03-2018
rated GMP as Good.
Decision:
Brand Name +Dosage Form + Strength Sitag Tablet
Sitagliptin Phosphate Monohydrate Eq. to
Sitagliptin…100mg
02-2018
Pharmacological Group oral blood glucose lowering drugs
Type of Form Form-5
Approval status of product in Sitagliptin 100 mg film-coated tablets by M/s
Reference Regulatory Authorities Laboratoires Biogaran (MHRA Approved)
Me-too status (with strength and A-Glip 100mg Tablets by M/s Atco Laboratories Ltd
dosage form) (Reg#053096)
rated GMP as Good.
Decision:
Brand Name +Dosage Form + Strength Metco Tablet
Sitagliptin…50mg
Metformin HCl…500mg
02-2018
Type of Form Form-5
Approval status of product in Janumet tablets of (TGA approved)
Me-too status (with strength and S-Gliptin Plus Tablets of M/s Barrett Hodgson
dosage form)
rated GMP as Good.
Decision:
Sitagliptin…50mg
02-2018
Type of Form Form-5
Me-too status (with strength and S-Gliptin Plus Tablets of M/s Barrett Hodgson
dosage form)
rated GMP as Good.
Decision:
Sitagliptin…50mg
02-2018
Type of Form Form 5
Me-too status (with strength and Silmax-M 50mg/1000mg Tablet by M/s High-Q
rated GMP as Good.
Decision:
70. Name and address of manufacturer / M/s Scilife Pharma Pvt Ltd.

Applicant Plot # FD-57/58-A2, Korangi Creek Industrial Park,
Karachi
Brand Name +Dosage Form + Strength Lowsartan 25mg Tablet
Losartan potassium…25mg
02-2018
Pharmacological Group Antihypertensive
Type of Form Form 5
Pack size & Demanded Price 14’s, 20’s, 30’s, 100’s ; As per SRO
Me-too status (with strength and Rosar 25mg Tablets of M/s Rock Pharmaceuticals
dosage form)
GMP status Last inspection report 5-12-2017 Manufacturer’s
overall rating is good compliance.
Decision:
71. Name and address of manufacturer / M/s Scilife Pharma Pvt Ltd.
Applicant Plot # FD-57/58-A2, Korangi Creek Industrial Park,
Karachi
Brand Name +Dosage Form + Strength Lowsartan 50mg Tablet
02-2018
Type of Form Form 5
Pack size & Demanded Price 14’s, 20’s, 30’s, 100’s; As per SRO
Approval status of product in Cozaar, 50 mg of ( USFDA Approved)
Me-too status (with strength and Jasartan Tablets 50mg of M/S Jawa Pharmaceutical
dosage form)
GMP status Last inspection report 5-12-2017 Manufacturer’s
overall rating is good compliance.
Decision:
72. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. E-145 to E-149, North Western Industrial
Zone, Port Qasim, Karachi, Pakistan
Brand Name +Dosage Form + Strength VilGlip-M Tablet 50/500
Composition Each film coated Tablet contains:
Vildagliptin…50mg
02-2018
Pharmacological Group Antihyperglycemic agent
Type of Form Form 5
Pack size & Demanded Price As per PRC
Approval status of product in GA Galvumet Tablet Of (TGA Approved)
Me-too status (with strength and Galmet 50mg/500mg Table M/s Vision Pharmaceuticals,
dosage form)
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 guideline
Remarks of the Evaluator4 Shelf life of 18 months with packaging

material of PA/Al/PVC/Al -polyamide-aluminum foil-
polyvinylchloride/aluminum foil or
PCTFE/PVC/Alu or 2 years with PA/Alu/PVC/Alu.
Decision:
Brand Name +Dosage Form + Strength VilGlip-M Tablet 50/1000
Composition Each film coated Tablet contains:
Vildagliptin…50mg
02-2018
Pharmacological Group Antihyperglycemic agent
Type of Form Form 5
Approval status of product in GA Galvumet Tablet Of (TGA Approved)
Me-too status (with strength and Galmet 50mg/1000mg Table M/s Vision
dosage form) Pharmaceuticals,
the
Remarks of the Evaluator4 Shelf life of 18 months with packaging

material of PA/Al/PVC/Al -polyamide-aluminum foil-
polyvinylchloride/aluminum foil or
PCTFE/PVC/Alu or 2 years with PA/Alu/PVC/Alu.
Decision:
Brand Name +Dosage Form + Strength Fosmicin Capsule 500mg
Fosfomycin (as Calcium)…500mg
02-2018
Pharmacological Group Anti Bacterial Agent
Type of Form Form 5
Approval status of product in Fosfomicina calcica solufos 500mg capsule by
Reference Regulatory Authorities Spain

Me-too status (with strength and Cynfo 500mg Capsule of M/s Sami
dosage form)
the

Decision:
Brand Name +Dosage Form + Strength Fosmicin Suspension 250mg/5ml
02-2018
Type of Form Form 5
Approval status of product in FOSFOCINA Suspension 250mg/5ml by Spain
Me-too status (with strength and Fosfonex 250mg/5ml Suspension of M/s Nexus Pharma
dosage form)
the

Decision:
76. Name and address of manufacturer / M/s Nabiqasim Industries Pvt Ltd.
Applicant 17/24, Korangi Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Strength Norlim-M Tablet 2/500mg
Composition Each fim coated tablet Contains:
Glimipride…2mg
Metformin HCl USP…500mg
02-2018
Pharmacological Group Anti-Diabetic
Type of Form Form 5
Pack size & Demanded Price 30’s, ; As per PRC
Approval status of product in Not found
Me-too status (with strength and Gpride-M SR Tablet M/s Sami pharamaceuticals
dosage form)
GMP status Last GMP of Nabi qasim Inspection conducted on
03-8-
2018 and report concludes that firm is considered to be
operating at an acceptable level of compliance of GMP
requirements. .

Remarks of the Evaluator4  Evidence of approval of applied formulation in
reference regulatory authorities/agencies
Decision:
77. Name and address of manufacturer / M/s Crystolite Pharmaceuticals.
Applicant Plot # 1 & 2, Street S-2, National Industrial Zone,
Rawat, Islamabad
Brand Name +Dosage Form + Strength Sinofex 5mg Tablets
Solifenacin succinate……………….5mg
02-2018
Pharmacological Group Urologicals
Type of Form Form 5
Pack size & Demanded Price 10’s, 30’s ; As per SRO
Approval status of product in SEYLACINE 5 MG of MHRA approved
Me-too status (with strength and Urgesin 5mg Tablet of AGP
dosage form)
GMP status Routine GMP inspection conducted on 17-10-2017
concluded that the firm is operating at agood level
of GMP compliance.
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Sinofex 10mg Tablets
Solifenacin succinate……………….10mg
02-2018
Pharmacological Group Urologicals
Type of Form Form 5
Pack size & Demanded Price 10’s, 30’s ; As per SRO
Approval status of product in SEYLACINE 10 MG of MHRA approved
Me-too status (with strength and Urgesin 10mg Tablet of AGP
dosage form)
of GMP compliance.
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Ketolite
α-Ketoanalogue to DL-isoleucine (Calcium-salt)…67mg
α-Ketoanalogue to isoleucine (Calcium-salt)…101mg
α-Ketoanalogue to phenylalanine (Calcium-Salt)…68mg
α-Ketoanalogue to valine (Calcium-Salt)…86mg
α-hydroxyanalogue to DL-methionine (Calcium-Salt)...59mg
L-lysine acetate...105mg corresponding to...75mg L-lysine
L-threonine...53mg
L-tryptophan...23mg
L-histidine...38mg
L-tyrosine...30mg
Total nitrogen content per tablet....36mg
Calcium content per tablet...1.25mmol = 50mg
02-2018
Pharmacological Group Calcium and analogue of essential amino acids
Type of Form Form 5
Pack size & Demanded Price 10’s x 10’s, ; As per SRO
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)
of GMP compliance.
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Urexa 40mg Tablets
Febuxostat…40mg
02-2018
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase
Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 30’s ; As per SRO
Approval status of product in Uloric 40mg Tablet of (USFDA approved)
Me-too status (with strength and Febuxin 40mg Tablet of M/s AGP
dosage form)
of GMP compliance..
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Urexa 80mg Tablets
Febuxostat…80mg
02-2018
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase
Inhibitor)
Type of Form Form 5
Approval status of product in Uloric 80mg Tablet of (USFDA approved)
Me-too status (with strength and Febuxin 80mg Tablet of M/s AGP
dosage form)
of GMP compliance..
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Frocit 10mEq Tablet
Composition Each extended release tablet contains;
Potassium citrate …10mEq
02-2018
Pharmacological Group Urinary Alkalinizing agent
Type of Form Form 5
Approval status of product in Urocit-K ( of USFDA approved
Me-too status (with strength and Lospin Tablets by Valor Pharmaceuticals
dosage form)
of GMP compliance.
Decision:
83. Name and address of manufacturer / M/s Wellborne Pharmachem & Biologicals.
Applicant Plot No. 51/1, 52/2, Phase I & II, Hattar Industrial
Estate, Hattar, K.P.K
Brand Name +Dosage Form + Strength Wellverin 135mg Tablet
Mebeverine hydrochloride (BP)…135mg
02-2018
Pharmacological Group Anti-Spasmodic
Type of Form Form 5
Pack size & Demanded Price 3 x 10’s ; As per SRO
Approval status of product in Mebeverine hydrochloride 135 mg of MHRA
Reference Regulatory Authorities approved
Me-too status (with strength and Mevos Tablets 135mg of M/s. Dyson Research
GMP status Last GMP inspection report dated 08-08-2018
recommending renewal of DML.

Decision:
Brand Name +Dosage Form + Strength Winfo 500mg Capsules
Composition Each capsules contains:
Fosfomycin calcium eq. to fosfomycin (BP)…500mg
02-2018
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s As per SRO
Approval status of product in Fosfomicina calcica solufos 500mg capsule by
Reference Regulatory Authorities Spain
Me-too status (with strength and Cynfo 500mg Capsule of M/s Sami
dosage form)
Decision:
Brand Name +Dosage Form + Strength Werison 50mg Tablet
Eperisone HCl…50mg
02-2018
Pharmacological Group Other centrally acting agents
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s, 3 x 10’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 (Reg# 039302)
dosage form)
Decision:
Brand Name +Dosage Form + Strength Zumax 200mg Tablet
Cefixime as trihydrate…200mg
02-2018
Type of Form Form 5
Approval status of product in Cefixime 200mg of MHRA approved
Me-too status (with strength and Caricef 200mg Tablet of M/s Sami
dosage form)
Decision:
87. Name and address of manufacturer / M/s Welmark Pharmaceuticals.
Applicant Plot #122 Phase 5, Block B, Industrial Hattar
Brand Name +Dosage Form + Strength Mark-Aid 500mg
Diflunisal…500mg
02-2018
Type of Form Form 5
Approval status of product in Diflunisal 500mg of MHRA approved
Me-too status (with strength and Dolobis-500 Tablets of M/s Genome Pharmaceuticals
dosage form)
GMP status Last GMP inspection was conducted on 16-09-2017
and report concludes that firm was GMP compliant.
Decision:
Brand Name +Dosage Form + Strength Noximark 4mg Tablet
Lornoxicam…4mg
02-2018
Type of Form Form 5
Approval status of product in Xefo 4 mg tablet (EMA approved)
Me-too status (with strength and Lorfix 4mg Tablet of M/s AGP
dosage form)
Decision:
Brand Name +Dosage Form + Strength WelVit Injection
Composition Each 3ml Injection contains:
Cyanocobalamin……..1000mcg
Pyridoxine…….. 100mg
Thiamine HCl (Vitamin B1) ……… 100mg

02-2018
Pharmacological Group Vitamin B compounds
Type of Form Form 5
Pack size & Demanded Price 5’s :As per SRO
Approval status of product in Neurobion solution for Injection 3ml by M/s Merck
Reference Regulatory Authorities Selbstmedikation GmbH (Germany Approved)
Me-too status (with strength and Neurolina Injection 3ml by M/s Alina Combine
Decision:
Brand Name +Dosage Form + Strength Atrawel 50mg/5ml Injection
Composition Each ampoule contains:
Atracurium Besylate (USP)…50mg
02-2018
Pharmacological Group Non depolarizing muscle relaxant
Type of Form Form 5
Approval status of product in MHRA approved
Me-too status (with strength and Atrium Injections by M/s Searle Pakistan, Karachi
Decision:
Brand Name +Dosage Form + Strength Weloskiren 150mg
Aliskiren (as hemifumerate)…150mg
02-2018
Pharmacological Group Renin inhibitors
Type of Form Form 5
Approval status of product in Tekturna USFDA approved
Me-too status (with strength and Stay Tablet 150mg of M/s Wilson’s Pharmaceuticals,
dosage form)
Remarks of the Evaluator4 Correction of salt Aliskiren (as hemifumerate) without
submission of fee.

Decision:
Brand Name +Dosage Form + Strength Weloskiren 300mg
Aliskiren(as hemifumerate)…300mg
02-2018
Pharmacological Group Renin inhibitors
Type of Form Form 5
Approval status of product in Tekturna USFDA approved
dosage form)
submission of fee.
Decision:
Brand Name +Dosage Form + Strength Weloskiren HCt
Aliskiren(as hemifumerate)…150mg
Hydrochlorthiazide…25mg
02-2018
Pharmacological Group Renin inhibitors and diuretic
Type of Form Form 5
Approval status of product in Tekturna HCT USFDA approved
dosage form)
submission of fee.
Decision:
94. Name and address of manufacturer / M/s Bajwa Pharmaceuticals (Pvt) Ltd.
Applicant 36-Km, GT Road Khori Murredke,Sheikhupura
Brand Name +Dosage Form + Strength Ioprowa Injection
Composition Each ml contains:
Iopromide…623.4mg (equivalent to 300mg Iodine).
02-2018
Pharmacological Group Radiographic contrast medium
Type of Form Form 5
Pack size & Demanded Price 100ml x 1’s As per PRC
Approval status of product in Ultravist® 300 of MHRA approved
Me-too status (with strength and Ultravist® 300 of M/s. Medipharm
dosage form)
and report concludes that 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:
Brand Name +Dosage Form + Strength Falfin Injection
Nalbuphine HCl…10mg
02-2018
Pharmacological Group Opiate analgesic
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s; RS: 45/1 Ampoule
Approval status of product in Nalbuphine Hydrochloride of USFDA approved
Me-too status (with strength and Nalphin 20mg Injection of M/s Pharmatec
dosage form)
Decision:
Brand Name +Dosage Form + Strength B-CIN 50 Injection
Amikacin (Sulphate)…50mg
02-2018
Type of Form Form 5
Pack size & Demanded Price 1ml x 1’s & 1ml x 05;As per PRC
Approval status of product in Amikacin of USFDA approved
Me-too status (with strength and Grasil 50mg Injection of M/s Sami Pharmaceuticals,
dosage form)

Decision:
Brand Name +Dosage Form + Strength B-CIN 100mg/2ml Injection
02-2018
Type of Form Form 5
Pack size & Demanded Price 2ml x 1’s : 2ml x 5’s & 2ml x 10’s ;As per SRO
Approval status of product in Amikin Injection Of MHRA Approved
Me-too status (with strength and Nekrocin 100 Injection of M/s Safe Pharmaceuticals,
dosage form)
Decision:
02-2018
Type of Form Form 5
Approval status of product in Briklin 250mg/2ml by EMA
Me-too status (with strength and Aminocin 250mg Injection of M/s Macquins International,
dosage form)
Decision:
02-2018
Type of Form Form 5
Approval status of product in Amikacin Injection Of USFDA Approved
Me-too status (with strength and Dunkin 500mg Injection of M/s Amros Karachi .
dosage form)
Decision:
100. Name and address of manufacturer / M/s Aries Pharmaceuticals.
Applicant 1-W, Industrial Estate, Hayatabad, Peshawar, k.p.k
Brand Name +Dosage Form + Strength Amoston conti Tablet
Composition Each blister pack contains:
14 White film coated Tablet Contains:
Estradiol as Hemihydrate (USP)………1mg
14 Brown Film Coated Tablet Contains:
Estradiol as Hemihydrate (USP)………….1mg
Dydrogesterone (USP)…5mg
02-2018
Pharmacological Group Progestogen and synthetic steriod
Type of Form Form 5
Pack size & Demanded Price 1 x 28’s : As per SRO
Approval status of product in FEMOSTON 1/5 tablet by Netherland Approved
Me-too status (with strength and Femoston Conti Tablets Of M/S ABOTT
dosage form)
and report concludes that panel recommend the grant of
additional sections
Remarks of the Evaluator4 Tablet Hormone section available
Decision:
101. Name and address of manufacturer / M/s Aries Pharmaceuticals.
Applicant 1-W, Industrial Estate, Hayatabad, Peshawar, k.p.k
Brand Name +Dosage Form + Strength Amoston Tablet
Composition Each blister pack contains:
14 White film coated Tablet Contains:
Estradiol as Hemihydrate (USP)…1mg
14 Brown Film Coated Tablet Contains:
Estradiol as Hemihydrate (USP)…1mg
Dydrogesterone (USP)…10mg
02-2018
Pharmacological Group Progestogen and synthetic steriod
Type of Form Form 5
Pack size & Demanded Price 1 x 28’s : As per SRO
Approval status of product in FEMOSTON 1/10 tablet by Netherland Approved
Me-too status (with strength and Femoston 1/10 Tablets Of M/S ABOTT
dosage form)
and report concludes that panel recommend the grant of
additional sections
Remarks of the Evaluator4 Tablet Hormone section available
Decision:
102. Name and address of manufacturer / M/s Magns Pharmaceuticals.
Applicant Plot No. 7-B, Value Addition City Faisalabad
Brand Name +Dosage Form + Strength Cilox Dry Powder Suspension
Ciprofloxacin (as taste mask granules 35%)…125mg
02-2018
Pharmacological Group Macrolide Antibiotic
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
the
report concludes that the firm was considerd to be opeating
at Good level of compliance.
Remarks of the Evaluator4  Source of granules: Vision
Decision:
103. Name and address of manufacturer / M/s Macter International Limited.
Applicant F-216, S.I.T.E. Karachi, Pakistan
Brand Name +Dosage Form + Strength Dapozin-M 5mg+850mg
Composition Each tablet contain:
Dapagliflozin……..5mg
Metformin……….850mg
02-2018
Pharmacological Group Antidiabetic
Type of Form Form 5-D
Finished product Specifications Manufacturer specification.
Pack size & Demanded Price 14’s, 28’s
RS: 5000/14’s & 10500/28’s
Approval status of product in EMA approved
Me-too status (with strength and Not found
dosage form)
and report concludes manger agreed to overcome the
shortcomings and submit compliance reporthence
reinspection will be conducted accordingly.
Remarks of the Evaluator4 Stability data required
104. Name and address of manufacturer / M/S Wahaabsons Pharma (Pvt) Ltd. 4 KM Buner Road
Applicant Barikot, Swat.

Brand Name +Dosage Form + Strength Wablex L Syrup
Composition Each 5ml contains
Vitamin B1... 4.16mg
Vitamin B2... 1.66mg
Vitamin B6....1mg
Vitamin B12... 8.33mcg
Niacinamide….18mg
Sodium d-pantothenate…..2.5mg (Calcium d
Pantothene………2.5mg)
Vitamin C….75mg
Inositol…...5mg
Lysine Monohydrochloride….33.33mg
Pharmacological Group Nutritional supplements
Type of Form Form 5
Finished product Specifications Manufacture’s specification
Pack size & Demanded Price 120ml ;As Rs: 60/
Approval status of product in N/A
Me-too status (with strength and Lyodex Syrup of M/s Cardex Pharmaceutical,
dosage form)
GMP status Last GMP inspection conducted on 25-10-2018
Recommendations:
Apart from the aforementioned recommendations, the
firm is further advised to:
1- To develop an independent quality assurance
department and appoint an experienced quality
assurance manager.
2- To improve the water treatment system by
installing double RO system along with the currently
installed de-ionizer system.
All the above points were discussed with the firm’s
management and they agreed comply them at the
earliest under intimation to the area FID.
Remarks of the Evaluator  Revision in master formulation Sodium d pantothenate

is replaced with Calcium d-pantothenat.
Decision:
105. Name and address of manufacturer / M/s Pharmedic Laboratories (Pvt) Ltd,Lahore
Applicant
Brand Name +Dosage Form + Strength Nofat 60mg Capsule

Orlistat..........60mg
Diary No. Date of R& I & fee Dy.No.12292 1-10-2015 Rs. 20,000
Pharmacological Group Lipase inhibitor
Type of Form Form 5
Approval status of product in Beacita 120mg Capsules of( MHRA approved)
Me-too status (with strength and Orlisat 120mg Capsules by M/s Merck Sharp & Dhome,
dosage form)

GMP status Last inspection conducted on 31-08-2018and report
concludes that firm was considered to be operating at
satisfactory level of compliance with GMP
Remarks of the Evaluator4  Source of pellets: Vision
Decision:
106. Name and address of manufacturer / M/s Pharmedic Laboratories (Pvt) Ltd,Lahore
Applicant
Brand Name +Dosage Form + Strength Peta 20mg Tablet
Composition Each tablet contains:
Piroxicam β-Cyclodextrin Eq.to Piroxicam.........20mg.
Diary No. Date of R& I & fee Dy. No. 1226 21-10-2015 Rs. 20,000
Type of Form Form 5
Finished product Specifications Manufacturer Specs
Approval status of product in Cycladol tablet ( ANSM approved)
Me-too status (with strength and Pirujin Tablet M/s Jupiter Pharma
dosage form)
GMP status Last inspection conducted on 31-08-2018and report
concludes that firm was considered to be operating at
satisfactory level of compliance with GMP
Decision:
107. Name and address of manufacturer / M/s Sharex Laboratories (Pvt) Ltd, Sadiqabad
Applicant
Brand Name +Dosage Form + Strength Tracodil-Cough Syrup

Ammonium Chloride…125
Sodium Citrate……55mg
Chlorpheniramine maleate………2.5mg
Menthol……..1mg
Diary No. Date of R& I & fee Dy. No. 2439 07-06-2016 Rs. 20,000
Pharmacological Group Anti-tussive
Type of Form Form 5
Finished product Specifications Manufacturer Specs
Pack size & Demanded Price 120ml Rs; 59/-
Approval status of product in Not provided
Me-too status (with strength and Sypriton Syrup of M/s Sayyed Pharmaceuticals (but no
dosage form) menthol
Remisole-neo of M/s Remington pharmaceuticals

(Glycerin 150mg)
GMP status Last GMP inspection conducted on 29-03-2017 ,and the
report concludes that firm is at satisfactory level of GMP
compliance.
.
Remarks of the Evaluator4 Change of Brand Names
 Tracodil C
 Tracodil P
 Tracodil Koff
Decision:

108. Name and address of manufacturer / M/s Axis Pharmaceuticals, Value Addition City,
Applicant 3-B, 1.5Km, Khurrianwala-Sahianwala Road,
Faislabad
Brand Name +Dosage Form + Strength Glovin Tablet 850mg
Composition Each film coated tablet contains:-

Metformin-HCl (BP)……..850mg
Diary No. Date of R& I & fee Dy. No. 2329/R&I dated 03.04.2015
Rs.12000/= 31.03.2015
Dy. No. 742/DDC-R-V dated. 13.04.2015
8000/-04-06-11
Pharmacological Group Biguanide
Type of Form Form 5
Pack size & Demanded Price 30’s : As per SRO
Approval status of product in Glucophage 850 Mg Of USFDA Approved
Me-too status (with strength and Glucophage 850 mg of M/s Merck
dosage form)
GMP status Last GMP inspection conducted on 19-09-2018 & 03-
10-2018,and the report concludes that firm is at
Operating fair level of GMP compliance.
.
Decision:
109. Name and address of manufacturer / M/s Axis Pharmaceuticals, Value Addition City,
Applicant 3-B, 1.5Km, Khurrianwala-Sahianwala Road,
Faislabad
Brand Name +Dosage Form + Strength Transix 500mg Capsule

Tranexamic Acid (BP)………500mg
Diary No. Date of R& I & fee Dy. No. 2329/R&I dated 03.04.2015
Rs.12000/= 31.03.2015
Dy. No. 742/DDC-R-V dated. 13.04.2015
8000/-04-06-11
Pharmacological Group Haemostatic/ Fibrinolytic
Type of Form Form 5
Finished product Specifications JP
Approval status of product in Tranxe of AIFa Italy approved
Me-too status (with strength and Bleex 500 .mg Capsule of M/s Navegal Laboratories
dosage form)
10-2018,and the report concludes that firm is at
Operating fair level of GMP compliance.
.
Decision:
110. Name and address of manufacturer / M/S Saibins Pharmaceuticals Plot # 316 Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Saipram 5mg tablet

Escitalopram (as oxalate) USP.......5mg
Diary No. Date of R& I & fee Dy. No. 2913 21-12-2015 Rs. 20,000/-
Pharmacological Group Selective Serotonin Reuptake Inhibitors (SSRIs)
Type of Form Form 5
Approval status of product in Escitalopram 5 mg Of ( MHRA Approved)
Me-too status (with strength and Gentle 5mg Tablet Of M/S Wilson’s Pharmaceuticals,
dosage form)
12- 2018 and the report concludes that panel
unanimously
recommended the renewal of DML 000773 by way
of
formulation of M/s Saibins Pharmaceuticals
Islamabad..
Decision:
Brand Name +Dosage Form + Strength Saipram 20mg tablet

Escitalopram (as oxalate) USP.......20mg
Diary No. Date of R& I & fee Dy. No. 2913 21-12-2015 Rs. 20,000/-
Pharmacological Group Selective Serotonin Reuptake Inhibitors (SSRIs)
Type of Form Form 5
Approval status of product in Escitalopram 20 mg Of ( MHRA Approved)
Me-too status (with strength and Gentle 20mg Tablet Of M/S Wilson’s harmaceuticals,
dosage form)
unanimously
of
formulation of M/s Saibins Pharmaceuticals
Islamabad..
Decision:
Brand Name +Dosage Form + Strength Topira 50mg Tablet
Topiramate……….50mg
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 50mg Tablets of M/S Helix Pharma
dosage form)
unanimously
of
formulation of M/s Saibins Pharmaceuticals Islamabad..
Remarks of the Evaluator The official monograph is available in USP
Decision:
Brand Name +Dosage Form + Strength Topira 100mg Tablet
Topiramate……….100mg
Pharmacological Group Antiepileptic agent
Type of Form Form 5
Approval status of product in Topamax Of ( USFDA Approved)
Me-too status (with strength and Epilock 100 mg Tablets of M/S Welmark
unanimously
of
Decision:
Brand Name +Dosage Form + Strength Tazip 15mg tablet
Mirtazaipine ……. 15mg
Pharmacological Group Antidepressant
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s; As per SRO
Approval status of product in Mirtazapine of (MHRA Approved)
Me-too status (with strength and Tazemir 15mg Tablet of M/s Lisko Pakistan
dosage form)
unanimously
of
Decision:
Brand Name +Dosage Form + Strength Tazip 30mg tablet
Mirtazaipine ……. 30mg
Type of Form Form-5
Pack size & Demanded Price 2 x 10’s; As per SRO
Approval status of product in Mirtazapine of (MHRA Approved)
Me-too status (with strength and Tazemir 30mg Tablet of M/s Lisko Pakistan
dosage form)
unanimously
of
Decision:
116. Name and address of manufacturer / M/S Global Pharmaceuticals (Pvt) Ltd, Plot # 204-
Applicant 205, Industrial Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Mecomed 1000mcg Injection
Mecobalamine JP ……….1000mcg
Pharmacological Group Viitamin
Type of Form Form 5
Pack size & Demanded Price 1ml x 10’s : As per SRO
Approval status of product in Not found
dosage form)
GMP status Last GMP inspection was conducted on 11 & 24-10-
2018 and the report concludes that panel unanimously
decided to recommend the issuance of GMP
Remarks of the Evaluator 4
 Evidence of approval of applied formulation in
declared/approved by the Registration Board in its 275 th
meeting.
 Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm.
Decision:
117. Name and address of manufacturer / M/s Werrick Pharmaceuticals.
Applicant 216-217,I-10/3, Industrial Area, Islamabad
Brand Name +Dosage Form + Strength EbaSoft Liquid
Composition Each 5ml Contains:

Ebastine…5mg
02-2018
Pharmacological Group Anti-histamine
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml ; As per SRO
Approval status of product in Ebastel oral solution 1mg/ml of Almirall, Spanish
Reference Regulatory Authorities medicine agency
Me-too status (with strength and Sebastine syrup of Vision Pharma

dosage form)
concluded that the firm is operating at a very good level
of GMP compliance.
.
Decision:.
Brand Name +Dosage Form + Strength Flueze-Extra Tablets 200/5mg
Ibuprofen…200mg
Phenylephrine Hydrochloride…5mg
02-2018
Pharmacological Group NSAID & Sympathomimetic decongestant
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, ; As per SRO
Approval status of product in Nurofen Cold & Flu Relief 200mg/5mg Tablets.
dosage form)
of GMP compliance .
Remarks of the Evaluator4 Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number,
brand name and name of firm
Decision:
Brand Name +Dosage Form + Strength Flueze-Extra Tablets 200/10mg
Ibuprofen…200mg
Phenylephrine Hydrochloride…10mg
02-2018
Pharmacological Group NSAID & Sympathomimetic decongestant
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, ; As per SRO
Approval status of product in ADVIL CONGESTION RELIEF of USFDA
dosage form)
of GMP compliance
Decision:
Brand Name +Dosage Form + Strength Flueze Expectorant
Guaifenesin…50mg
02-2018
Pharmacological Group Expectorant
Type of Form Form 5
Pack size & Demanded Price 60ml ; As per SRO
Approval status of product in Lemsip Cough for Chesty Cough of MHRA approved
dosage form)
of GMP compliance.
Decision:
Brand Name +Dosage Form + Strength Flueze-Extra Sachets
Composition Each Sachet contains:
Paracetamol…1000mg
Phenylephrine Hydrochloride…12.2mg
Guaifenesin…200mg
02-2018
Pharmacological Group NSAID & Sympathomimetic decongestant & Expectorant
Type of Form Form 5
Approval status of product in Lemsip Cough Max for Mucus Cough & Cold
Reference Regulatory Authorities 1000mg/200mg/12.2mg Powder for Oral Solution of
MHRA approved
dosage form)
of GMP compliance.

Decision:
Brand Name +Dosage Form + Strength Flueze-Extra Capsules
Paracetamol…500mg
Phenylephrine Hydrochloride…6.1mg
Guaifenesin…100mg
02-2018
Pharmacological Group NSAID & Sympathomimetic decongestant & Expectorant
Type of Form Form 5
Approval status of product in Lemsip Cough Max for Mucus Cough & Cold
Reference Regulatory Authorities 500mg/100mg/6.1mg Powder for Oral Solution of MHRA
approved
dosage form)
of GMP compliance.
Decision:
Brand Name +Dosage Form + Strength Fluezo Pro Tablets
Ibuprofen…150mg
Paracetamol…500mg
02-2018
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As per SRO
Approval status of product in Combogesic 500 Mg/150 Mg Film-Coated Tablets of
Reference Regulatory Authorities MHRA approved

dosage form)
of GMP compliance.
Decision:
124. Name and address of manufacturer / M/s Atco Laboratories Limited.B-18, S.I.T.E. Karachi
Applicant
Brand Name +Dosage Form + Strength Eskazole Tablets 200mg
th
| 68
Albendazole USP…200mg
02-2018
Pharmacological Group ANTHELMINTICS
Type of Form Form 5
Pack size & Demanded Price 2’s, 7’s, 14’s, 20’s, 28’s, 30’s & 60’s
RS: 100/2’s, 350/7’s, 500/10’s,700/14’s 1000/20’s,
1400/28’s, 1500/30’s & 3000/60’s
Approval status of product in ALBENZA Of USFDA Approved
Me-too status (with strength and Bentil Tablets of M/s Alliance Pharmaceuticals
dosage form)
and report concludes that firm was considered to be
operating at good level of compliance
Decision:
Applicant
Brand Name +Dosage Form + Strength Eskazole Tablets 400mg
Albendazole USP…400mg
02-2018
Pharmacological Group ANTHELMINTICS
Type of Form Form 5
Pack size & Demanded Price 2’s, 7’s, 14’s, 20’s, 28’s, 30’s & 60’s
RS: 200/2’s, 700/7’s, 1000/10’s,1400/14’s 2000/20’s,
2800/28’s, 3000/30’s & 6000/60’s
Approval status of product in Eskazole 400mg tablet by GSK Austrailia
Me-too status (with strength and Wormgo Tablets of M/s Mediceena Pharma
dosage form)
Decision:
Applicant
Brand Name +Dosage Form + Strength Carizole Topical Solution 1%w/v
Clotrimazole USP…10mg (1%w/v)
02-2018
Pharmacological Group Antifungal
Type of Form Form 5
Pack size & Demanded Price 5ml, 10ml, 15ml, 20ml, 30ml, &60ml
RS: 250/5ml, 500/10ml, 750/15ml, 1000/20ml, 1500/30ml,
&300/60ml
Approval status of product in Canesten Solution Of MHRA Approved
Me-too status (with strength and Not found (Firm provided Clotrimazole Solution 1% w/v
dosage form) in 137 meeting Registration No: 022958 Registration date
01-01-1999 Karachi chemicals Industries.
Remarks of the Evaluator4  Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
Decision:
127. Name and address of manufacturer / M/s Aspin Pharma Pvt Ltd.
Applicant Plot # 10 & 25, Sector 20, Korangi Industrial Area,
Karachi 74900, Pakistan
Brand Name +Dosage Form + Strength Obzinq 20mg Disperable Tablets
Composition Each disperible tablet contains:
Zinc Sulfate monohydrate 54.90mg eq. to Zinc…..20mg
02-2018
Pharmacological Group Antidiarrheal
Type of Form Form 5
Approval status of product in WHO prequalified Zincfant Tablet 20 mg manufactured
Reference Regulatory Authorities by Laboratoires Pharmaceutique s Rodael -France
Me-too status (with strength and Zinxus Tablet of M/s Ferozsons
dosage form)
and report concludes firm was operating at satisfactory
Decision:
128. Name and address of manufacturer / M/s Asian Continental Pvt Ltd.
Applicant Continental House, D/32, S.I.T.E. Super Highway,
Karachi
Brand Name +Dosage Form + Strength Roxam Uncoated Tablet
Piroxicam-β-Cyclodextrin…191.2mg eq. to Piroxicam
(USP)…….…20mg
02-2018
Type of Form Form 5
Pack size & Demanded Price 10’s ,20’s, ; As per DRAP policy
Approval status of product in Cycladol 20 mg Tablets of ( ANSM approved)
Me-too status (with strength and Pirujin Tablet M/s Jupiter Pharma
dosage form)
and report concludes that their current GMP compliance
level is rated as Good.

Decision:
Karachi
Brand Name +Dosage Form + Strength Prazo 0.25mg Tablet
Alprazolam (USP)…0.25mg
02-2018
Pharmacological Group Benzodiazepine derivatives
Type of Form Form 5
Pack size & Demanded Price 3 x 10’s , ; As per DRAP policy
Approval status of product in Xanax 250 microgram Tablets by M/s Pfizer Limited
Reference Regulatory Authorities (MHRA Approved)
Me-too status (with strength and Alprazolam 0.25mg Tablets by M/s Heal Pharmaceutical
dosage form)
GMP status Last GMP inspection was conducted on 6/14/2018
Remarks of the Evaluator4 Psychotropic section is not available.
Decision:
Karachi
Brand Name +Dosage Form + Strength Prazo 0.5mg Tablet
Alprazolam (USP)…0.5mg
02-2018
Type of Form Form 5
Pack size & Demanded Price 3 x 10’s , ; As per DRAP policy
Approval status of product in Xanax 500 microgram Tablets by M/s Pfizer Limited
Reference Regulatory Authorities (MHRA Approved)
Me-too status (with strength and Alprazolam 0.5mg Tablets by M/s Heal Pharmaceutical
dosage form)
Remarks of the Evaluator4 Psychotropic section is not available
Decision:
Evaluator PEC-V
131. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd, 539-A Sundar
Applicant Industrial Estate, Raiwind Road ,Lahore
Diary No. Date of R& I & fee Diary No:3061, 23/01/2018, Rs: 20,000/- Dated
18/01/2018
Brand Name +Dosage Form + Strength Diafax Tablet 550mg
Rifaximin……550mg

Pharmacological Group Antibiotics (A07AA11)
Type of Form Form 5
Finished product Specification Inhouse
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.
Remarks of the Evaluator. Tablet Section is approved.
Decision:
132. Name and address of manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd, 539-A Sundar
Applicant Industrial Estate, Raiwind Road ,Lahore
18/01/2018
Brand Name +Dosage Form + Strength Diafax Tablet 200mg
Rifaximin……200mg
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®
Rixago 200mg
M/s OBS Pharma Karachi . .
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.
Remarks of the Evaluator. Tablet Section is approved.
Decision:
133. Name and address of manufacturer / M/s Bloom Pharmaceuticals Pvt. Ltd.
Applicant Plot No. 30, Phase I and II, Industrial Estate, Hattar
23/01/2018
Brand Name +Dosage Form + Strength Austaban Cream
Composition Each g contains:
Mupirocin as Calcium….20mg
Pharmacological Group Antibiotics For Topical Use
D06AX09
Type of Form Form 5
Pack size & Demanded Price 15g, 30g, As Per SRO
Approval status of product in Reference Bactroban
Mupicin Cream.
M/s Shrooq Pharmaceuticals (Pvt) Ltd,Lahore.
GMP status 07-04-2018. Conclusion:
Overall the firm was operating under good level of
cGMP.
Remarks of the Evaluator. Cream section is present.
Decision:
23/01/2018
Brand Name +Dosage Form + Strength Blofol Syrup
Iron III hydroxide polymaltose complex eq. to
elemental iron…50mg
Folic acid…..0.35mg
Pharmacological Group Hematinic
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml in an amber glass bottle
Approval status of product in Reference NA
Bioron F Syrup 120ml
M/s Shaheen Pharmaceuticals,Swat
cGMP.
Remarks of the Evaluator. Liquid syrup section approval is present.
Decision:
23/01/2018
Brand Name +Dosage Form + Strength Blomine Tablet 500mcg
Mecobalamin….500mcg
Pharmacological Group Vitamin B12.
Type of Form Form 5
Finished product Specification JP
Pack size & Demanded Price 2x10’s, 3x10’s, 10x10’s, As per SRO.
Approval status of product in Reference PMDA Approved sugar coated
Heam 500 mcg Tablet
M/s Linear Parma, Rawat.Islamabad
cGMP.
Remarks of the Evaluator. Firm has revised their formulation from film coated to
sugar coated tablet without the submission of requisite
fee.
Decision:
136. Name and address of manufacturer / M/sWelmed Pharmaceutical Industries(Pvt)Ltd.
Applicant Plot No. 108- R-2,IndustrialEstate Gadoon, Dist.
Swabi, KPK

Brand Name +Dosage Form + Strength Mecowel Tablet 500mcg
Diary No. Date of R& I & fee Diary No:19684, 1/11/2017, Rs: 20,000/- Dated 19-
Oct-2017
Mecobalamin…500mcg
Pharmacological Group WHO ATC index also classifies Mecobalamin as
“Antianemic preparations”
Type of Form Form 5
Pack size & Demanded Price 7’s,14;s, 28’s. As per SRO
Approval status of product in Reference PMDA approved (as sugar coated)
Me-too status 039173 Nervon 500ug Tablets Each film coated
tablet contains:- Mecobalamin….500ug Getz
Pharma, Karachi
GMP status 04-03-2017,
Renewal of DML and grant of additional sections.
Remarks of the Evaluator. PMDA approved (as sugar coated). While the firm has
applied as film coated tablet.
Decision:
Swabi, KPK
Brand Name +Dosage Form + Strength Sitamin Tablet 500mg/50mg
Oct-2017
Sitagliptin(as phosphate monohydrate)…50mg
Metformin hydrochloride…..500mg
Pharmacological Group Dipeptidyl peptidase-4 inhibitor/Biguanide
Type of Form Form-5
Finished product Specification Manufacturer’s Specifications
Approval status of product in Reference Approved in US-FDA
Me-too status Glusimet 50mg/500mg Tablet of Opal Lab. Karachi.
Remarks of the Evaluator. The applied formulation is “Each film coated tablet
contains: Sitagliptin(as phosphate monohydrate)…50
mg whereas, in master formulation it is mentioned
“Each film coated tablet contains: Sitagliptin(as
phosphate monohydrate)…64.2 mg.
Decision:
Swabi, KPK
Brand Name +Dosage Form + Strength Sitamin Tablet 1000mg/50mg
Oct-2017
Type of Form Form-5
Finished product Specification Manufacturer’s Specifications
Me-too status Silmax-M 50mg/1000mg tablet of M/s. High-Q
Pharmaceuticals
Remarks of the Evaluator. The applied formulation is “Each film coated tablet
contains: Sitagliptin(as phosphate monohydrate)…50
mg whereas, in master formulation it is mentioned
“Each film coated tablet contains: Sitagliptin(as
phosphate monohydrate)…64.2 mg.
Decision:
139. Name and address of manufacturer / M/s Treat Pharmaceutical Industry Pvt. Ltd, A-37,
Applicant Small Industrial Estate, Township, Kohat Road,
Bannu
10/01/2018
Brand Name +Dosage Form + Strength Titamin Injection 500mg/10ml
Kemin, Treat me, Trimitek
Ketamine as Hydrochloride…..500mg/10ml
Pharmacological Group General anesthetics (N01AX03)
Type of Form Form 5
Pack size & Demanded Price 10ml glass ampoule, As per SRO.
Approval status of product in Reference Ketalar
10-mL multi-dose vial
Ketarol Injection 50mg/ml
M/s Global Pharmaceuticals, Islamabad.
GMP status Panel inspection dated 05-10-2017 recommended for
renewal of DML
Remarks of the Evaluator. International availability is in vial.
Section Approval: Liquid infusion.
Decision:
140. Name and address of manufacturer / M/s Zafa Pharmaceutical Laboratories Pvt. Ltd.,
Applicant L-4/1, A & B, Block-21, Federal B, Industrial Area,
Karachi
22/01/2018
Brand Name +Dosage Form + Strength Biozaf Tablet 150mg
Ibandronate monosodium monohydrate, equivalent to
Ibandronic acid…150mg
Pharmacological Group Drugs Affecting Bone Structure And Mineralization
Bisphosphonates (M05BA06)
Type of Form Form-5
Finished product Specification In-house
Pack size & Demanded Price 1’s, As per SRO.
Approval status of product in Reference Boniva Tablets

Franjic 150mg Tablet
M/s Martin Dow Ltd. Karachi. .
GMP status 11-01-2018, Renewal of DML.

Decision:
141. Name and address of manufacturer / M/s English Pharmacetuicals Industries, Link Kattar
Applicant Band Road, Thokar Niaz Baig, Multan Road
22/01/2018
Brand Name +Dosage Form + Strength Water for Injection 10ml
Water for injection …10ml
Pharmacological Group N/A
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 10ml ampoule, As per SRO
Approval status of product in Reference MHRA Approved
Water for Injection
M/s Genix Pharma Karachi .
GMP status 16-01-2018, Fair compliance except for penicillin
section.
Remarks of the Evaluator. Liquid Injection ampoule SVP is present.
Decision:
142. Name and address of manufacturer / M/s Medera Pharmaceuticals Pvt. Ltd
Applicant Plot 2, Street 4, National Industrial Zone, Rawat
Brand Name +Dosage Form + Strength Terbinafine Tablet 250 mg
Terbimed, Finomed, Binomed
Diary No. Date of R& I & fee Duplicate dossier
Terbinafine Hydrochloride eq. to Terbinafine ..250mg
Pharmacological Group Antifungals for systemic use (D01BA02)
Type of Form Form-5
Pack size & Demanded Price 10’s Alu Alu Blister, As per SRO
Approval status of product in Reference Lamisil terbinafine 250mg (as hydrochloride)
Regulatory Authorities. TGA Approved uncoated.
Cutis 250mg Tablet
M/s Tabros Pharma Karachi . .
GMP status 06-02-2018 Conclusion:
Keeping in view of the above facts, overall GMP
compliance is found Good as of today.
Remarks of the Evaluator.  Evidence of international availability and me-too
as film coated tablet is required.
 Firm has provided evidence of film coated tablets
which could not be confirmed.
 Present in USP
Decision:
143. Name and address of manufacturer / M/s Medera Pharmaceuticals Pvt. Ltd

Applicant Plot 2, Street 4, National Industrial Zone, Rawat
Brand Name +Dosage Form + Strength Orlimed Capsules 120 mg
Statomed, Obestat Capsule
Diary No. Date of R& I & fee Duplicate dossier
Orlistat…120mg
Pharmacological Group Peripherally acting anti-obesity products (A08AB01)
Type of Form Form-5
Pack size & Demanded Price 30’s Alu Alu Blister, As per SRO
Approval status of product in Reference Beacita 120mg Capsules, hard
Regulatory Authorities. MHRA Approved
Orlisat 120mg Capsules
M/s Sharp & Dhome, Karachi
Keeping in view of the above facts, overall GMP
compliance is found Good as of today.
Remarks of the Evaluator. Present in USP.
Provide source of pellets.
Decision:
144. Name and address of manufacturer / "M/s OBS Pakistan Private Limited.
Applicant C-14, S.I.T.E, Karachi, Pakistan"
Diary No. Date of R& I & fee Form-5 Dy.No 3194 dated 24-01-2018 Rs. 20,000
Dated 24-01-2018
Brand Name +Dosage Form + Strength Mezeron 15mg Tablet
Mirtazapine…15mg"
Pharmacological Group Antidepressants
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, As per SRO.
Approval status of product in Reference REMERON
Regulatory Authorities. USFDA Approved with box warning.
Mirtazameron Tablet 15mg
M/s Akson Pharmaceuticals Pvt Ltd, Islamabad
GMP status 15/11/17. Conclusion:
“Based on the areas visited people met and
documentation reviewed and found good and
compliant as per GMP requirement.”
Approval of Amendments in Approved Sections/
Facility (03-12-018):
1-Warehouse Hormone (Section) Amendment
2-Sachet section Hormone (Section) Amendment
3-Tablet section Hormone (Section) Amendment
4-Capsule Hormone Section Amendment
Decision:
145. Name and address of manufacturer / "M/s OBS Pakistan Private Limited.
Applicant C-14, S.I.T.E, Karachi, Pakistan"
Dated 24-01-2018
Brand Name +Dosage Form + Strength Mezeron 45mg Tablet
Mirtazapine…45mg
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, As per SRO.
Approval status of product in Reference USFDA Approved.
Charmfil 45mg Tablet
M/s. Wilshire Laboratories (Pvt) Ltd, Lahore.
“Based on the areas visited people met and
documentation reviewed and found good and
compliant as per GMP requirement.”
Approval of Amendments in Approved Sections/
Facility (03-12-018):
1-Warehouse Hormone (Section) Amendment
2-Sachet section Hormone (Section) Amendment
3-Tablet section Hormone (Section) Amendment
4-Capsule Hormone Section Amendment
Remarks of the Evaluator. Approved in USFDA with box warning.
Decision:
146. Name and address of manufacturer / M/s Spencer & Company Pvt Ltd., D-105, S.I.T.E
Applicant Karachi
Diary No. Date of R& I & fee Dy.No 2720 dated 19-01-2018 Rs. 20,000 Dated 19-
01-2018
Brand Name +Dosage Form + Strength Ibuflam 100mg/5ml Suspension, Inflagesic, Influben
Composition "Each 5ml Contains:
Ibuprofen…100mg"
Type of Form Form 5
Pack size & Demanded Price 60ml, As per SRO.
Approval status of product in Reference Company: ACTAVIS MID ATLANTIC
Ibo-Z Suspension 100mg.
Z-Jans Pharmaceuticals (Pvt) Ltd,Peshawar.
GMP status 29-08-2017, Satisfactory.

Decision:
Applicant Karachi"
01-2018
Brand Name +Dosage Form + Strength Calpen 50mg Tablets, Calate, Calviden
Composition Each Uncoated Tablet Contains:
Calcium D Pantothenate…50mg"
Pharmacological Group Vitamin B5
Type of Form Form 5
Pack size & Demanded Price 5x10’s, As per SRO.

Capcipan-T 50mg Tablet
M/s Ambrosia Pharmaceuticals, Islamabad
Remarks of the Evaluator. International availability could not be confirmed.

Decision:
Applicant Karachi"
01-2018
Brand Name +Dosage Form + Strength Tenor 50mg Tablets, Tenocard, Betasel
Atenolol…50mg
Pharmacological Group Beta blocking agents, selective
Type of Form Form 5
Pack size & Demanded Price 2x10’s, As per SRO
M-Nol 50 mg Tablet
M/s Mafins Karachi . .

Decision:
149. Name and address of manufacturer / M/s Safe Pharmaceutical Private Limited, C-I-20,
Applicant Sector 6-B, North Karachi, Industrial Area, Karachi
23/01/2018
Brand Name +Dosage Form + Strength Pregsafe Capsule 100mg
Pregabalin….100mg
Pharmacological Group Antiepileptic
N03AX16
Type of Form Form 5
Pack size & Demanded Price As per DRAP policy.
Approval status of product in Reference Lyrica USFDA Approved.
Balin 100mg
M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5,
National industrial zone Rawat.Islamabad
GMP status The firm was last inspected on 07.04.2018, wherein
the firm was at good cGMP.
Decision:
150. Name and address of manufacturer / M/s Safe Pharmaceutical Private Limited, C-I-20,
Applicant Sector 6-B, North Karachi, Industrial Area, Karachi

23/01/2018
Brand Name +Dosage Form + Strength Pregsafe Capsule 50mg
Pregabalin….50mg
N03AX16
Type of Form Form 5
Pack size & Demanded Price As per DRAP policy.
Approval status of product in Reference Lyrica USFDA Approved.
Balin 50mg
the firm was at good cGMP.
Decision:
151. Name and address of manufacturer / "M/s Hiranis Pharmaceuticals (Pvt.) Ltd.
Zone, Port Qasim, Karachi, Pakistan"
01-2018
Brand Name +Dosage Form + Strength Tizolex 2mg Tablets
Composition "Each Tablet Contains:
Tizanidine as HCl…2mg"
Pharmacological Group Muscle Relaxants
Type of Form Form-5
Pack size & Demanded Price As per SRO.
Approval status of product in Reference Tizanidine 2 mg Tablets
Tandolax 2mg Tablet by High-Q Pharmaceuticals,
Karachi . .
the firm was rated at satisfactory level of cGMP
compliance.
Decision:
01-2018
Brand Name +Dosage Form + Strength Tizolex 4mg Tablets
Tizanidine as HCl…4mg"
Pharmacological Group Muscle Relaxants
Type of Form Form-5
Approval status of product in Reference Tizanidine 4 mg Tablets
Tandolax 4mg Tablet by High-Q Pharmaceuticals,
Karachi . .
compliance.
Decision:
01-2018
Brand Name +Dosage Form + Strength Rosuvast 5mg Tablet
Rosuvastatin as Calcium…5mg
Pharmacological Group HMG CoA reductase inhibitors
Type of Form Form-5
Finished product Specification Mfg. Specs.
Pack size & Demanded Price 10’s, As per SRO.
Approval status of product in Reference Crestor USFDA Approved
Rosan Tablet 5mg
Sante Karachi . .
compliance.
Decision:
01-2018
Brand Name +Dosage Form + Strength Caweda 125mg Tablet
Terbinafine as HCL…125mg"
Type of Form Form-5
Pack size & Demanded Price 10’s, As per SRO
Approval status of product in Reference MHRA Approved.
Logirid Tablet 125mg
by Lowitt Pharmaceutical (Pvt) Ltd,
Plot.No.24 Industrial Estate, Peshawar.
compliance.
Decision:

01-2018
Brand Name +Dosage Form + Strength Caweda 250mg Tablet
Type of Form Form-5
Approval status of product in Reference MHRA Approved.
Logirid Tablet 250mg
by Lowitt Pharmaceutical (Pvt) Ltd,
Plot.No.24 Industrial Estate, Peshawar.
compliance.
Decision:
02-2018
Brand Name +Dosage Form + Strength Dolact Tablet 75mg/200mcg
Composition "Each film coated tablet contains:
Diclofenac Sodium (as enteric coated)…75mg
Misoprostol (1% HPMC Dispersion)…200mcg"
Pharmacological Group NSAID/Prostaglandin
Type of Form Form 5
Approval status of product in Reference Arthrotec
Misocot 75 Tablet
By M/s Nabiqasim Karachi . .
compliance.
Remarks of the Evaluator. Approved in USFDA with box warming.
Decision:
157. Name and address of manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25 &
Applicant 26, Street No. S-3, RCCI, National Industrial Zone,
Rawat, Islamabad
Brand Name +Dosage Form + Strength Alvas Tablets 10mg
Atorvastatin as calcium trihydrate....10mg
Diary No. Date of R& I & fee Dy.No. 6396 dated 21-02-2018; Rs. 20,000/- 19-02-
2018

Pharmacological Group Statin / HMG-CoA Reductase Inhibitor
Type of Form Form-5
Finished product Specification As per Inhouse Specifications
Pack size & Demanded Price 10’s, 20’s; As per SRO
Approval status of product in Reference Lipitor 10mg Film coated Tablets, Pfizer Ireland
Regulatory Authorities Pharmaceuticals, Ireland (MHRA Approved)
Hitor 10mg Tablet
M/s Hygeia Pharmaceuticals, Islamabad
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 Present in USP.
Decision:
Rawat, Islamabad
Atorvastatin as calcium trihydrate….. 20mg
2018
Type of Form Form-5
Hitor 20mg Tablet
M/s Hygeia Pharmaceuticals, Islamabad
recommendations:
inspected the firm has requisite manufacturing facility
for manufacturing of Pharmaceuticals.
Decision:
Rawat, Islamabad
Atorvastatin as calcium trihydrate ....40mg
2018
Type of Form Form-5
Finished product Specification As per in-house Specifications.
Atorscot Tablets 40mg
M/s Scotmann Pharmaceuticals, Plot NoE-5, Sector I-
10/3 Islamabad.
recommendations:
Decision:
Rawat, Islamabad
Atorvastatin as calcium trihydrate ....80mg
2018
Type of Form Form-5
"Lipirex Tablets 80mg.
"M/s Highnoon Laboratories, 17.5 Km Multan Road,
Lahore
recommendations:
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Alvas-EZ Tablets 10/10mg
Atorvastatin as calcium trihydrate...10mg
Ezetimibe …………………………..10mg
2018
Pharmacological Group Statin / Cholesterol Absorption Inhibitor
Type of Form Form-5
Approval status of product in Reference Atozet 10mg/10mg Film coated Tablets, Merck Sharp
Regulatory Authorities & Dohme Ltd. UK (MHRA Approved)
Atorax-E Tablets
"M/s. Dyson Research Laboratories (Pvt) Ltd,
28Km, Ferozepur Road, Lahore.
recommendations:
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Alvas-EZ Tablets 20/10mg
Atorvastatin as calcium trihydrate....20mg
Ezetimibe …………………………..10mg
Diary No. Date of R& I & fee Dy.No.6401 dated 21-02-2018; Rs. 20,000/- 19-02-
2018
Pharmacological Group Statin / Cholesterol Absorption Inhibitor
Type of Form Form-5
Finished product Specification As per inhouse Specifications
Approval status of product in Reference Atozet 20mg/10mg Film coated Tablets, Merck Sharp
Regulatory Authorities & Dohme Ltd. UK (MHRA Approved)
Lipiget EZ 40mg+10mg
M/s Getz Pharma Karachi .
recommendations:
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Alvas Plus Tablets 10/20mg
Amlodipine as besylate……………….....10mg
Atorvastatin as calcium trihydrate……....20mg
2018
Pharmacological Group Calcium Antagonist / Statin
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s, 14’s & 20’s; As per SRO
Approval status of product in Reference Caduet Tablets 10/20mg, Pfizer Inc. USA (USFDA
Regulatory Authorities Approved)
AM-Descol 10/20
Nabiqasim Indus, Karachi
recommendations:
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Simvax Tablets 10mg
Simvastatin……..10mg
Diary No. Date of R& I & fee Dy.No. 6403 dated 21-02-2018; Rs. 20,000/- 19-
02-2018
Type of Form Form-5
Finished product Specification USP Specifications
Approval status of product in Reference Zocor 10mg Tablets, Accord Healthcare Inc., USA
Regulatory Authorities (USFDA Approved)
Mistin 10mg Tablet.
M/s Mission Pharma. Karachi . .
recommendations:
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Mistin 20mg Tablet.
M/s Mission Pharma. Karachi . .
recommendations:
pharmaceutical; however,
keeping in view the facility inspected the firm has
requisite
manufacturing facility for manufacturing of
Pharmaceuticals.
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Approval status of product in Reference Simvastatin 40mg Tablets, Accord Healthcare Inc.,
Regulatory Authorities USA (USFDA Approved)
Tavam 40mg Tablet
M/s Zanctok Pharmaceuticals, Karachi
recommendations:
pharmaceutical; however,keeping in view the facility
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Modlip 80mg Tablets
"M/s Wilshire Laboratories, 124/A, Kotlakhpat, Indus.
Area, Township Scheme, Lahore.
recommendations:
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Simvax Plus Tablets 10/10mg
Simvastatin USP……...10mg
Ezetimibe USP……….…10mg
2018
Pharmacological Group HMG CoA reductase inhibitors in combination with
other lipid modifying agents
Type of Form Form-5
Approval status of product in Reference Vytorin 10mg/10mg Tablets, MSD International
Regulatory Authorities GmbH. (USFDA Approved)
Iril 10/10 Tablet
By M/s Genix Pharma (Pvt.) Ltd Karachi
recommendations:
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Iril 10/20 Tablet
recommendations:
for manufacturing of pharmaceuticals.
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Iril 10/40 Tablet
recommendations:
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Iril 10/80 Tablet
recommendations:
Decision:
Rawat, Islamabad
Brand Name +Dosage Form + Strength Rovastat Tablets 5mg
Rosuvastatin as Calcium……..5mg
2018
Type of Form Form-5
Approval status of product in Reference Crestor 5mg film coated Tablets, Astrazeneca UK ,
Regulatory Authorities Ltd. (MHRA Approved)
Rovista 5mg Tablets
M/s Getz Pharma, Karachi
recommendations:
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Rovista 10mg Tablets
recommendations:
Decision:
Rawat, Islamabad
2018
Type of Form Form-5
Rovista 20mg Tablets
recommendations:
Remarks of the Evaluator XIII
Decision:
Rawat, Islamabad
02-2018
Type of Form Form-5
Rosocard Tablets
"M/s Himont Pharma (Pvt.) Ltd., 17 Km Ferozpur
Road, Lahore.
recommendations:
Decision:
176. Name and address of manufacturer / M/s Wimits Pharmaceuticals Pvt. Ltd.
Applicant Plot 129 Sunder Industrial Estate Raiwind Lahore
Brand Name + Dosage Form + Strength DEPRE-F Capsule 3mg/ 25mg
Olanzapine…………………..3mg
Fluoxetine as hydrochloride…25mg
02-2018
Pharmacological Group Antidepressant ( SSRI), Antipsychotic
Type of Form Form 5
Pack size & Demanded Price Pack Size: 14’s,
Price: As per SRO
Approval status of product in SYMBAX Capsule USA (USFDA)
Me-too status Co-Depricap capsule (Reg 076136) Nabi Qasim
GMP status Last GMP inspection is conducted on 08/11/2018 and
The report concludes that firm was found to be
operating at good level of GMP compliance.
Remarks of the Evaluator Approved in USFDA with box warning.
Decision:
Brand Name + Dosage Form + Strength DEPRE-F Capsule 6mg /25mg
02-2018
Type of Form Form 5
Pack size & Demanded Price Pack Size: 14’s
Price: As per SRO
Approval status of product in SYMBAX capsule USFDA
Me-too status Co-Depricap capsule (Reg 076135) Nabi Qasim
Decision:
Brand Name + Dosage Form + Strength DEPRE-F Capsule 12mg/ 25mg
02-2018
Type of Form Form 5
Pack size & Demanded Price Pack Size: 14’s,
Price: As per SRO
Approval status of product in SYMBAX capsule USFDA
Olanzo F 12/25mg
Decision:
Brand Name + Dosage Form + Strength Flucona Capsule 150mg
Fluconazole ………….150mg
02-2018
Pharmacological Group Antifungal Agent
Type of Form Form 5
Price: As per SRO
Approval status of product in DIFLUCAN Fluconazole 150mg Capsules Blister
Reference Regulatory Authorities. TGA Approved.

Jutrazole Capsule
M/s Jupiter PharmaPlot # 25, St# S6 RCCI, Rawat
Islamabad
Remarks of the Evaluator Present in BP not in USP.
Decision:
Brand Name + Dosage Form + Strength Convulsant Capsule 4mg
Thiocolchicoside…4mg
02-2018
Pharmacological Group Muscle relaxant
Type of Form Form 5
Price: As per SRO
Approval status of product in Myoplege 4mg capsule France
Reference Regulatory Authorities. (ANSM APPROVED)
Colril Capsules
M/s Searle Pakistan, Karachi
Decision:
Evaluator PEC-VI
181. Name and address of manufacturer / M/s Remington Pharmaceuticals Industries Pvt Ltd.
Applicant Lahore
Brand Name +Dosage Form + Strength Citapram 5mg Tablet
Escitalopram Oxalate eq to Escitalopram..…5mg
Diary No. Date of R& I & fee Dy.No 22194 dated 27-11-2017 Rs. 20,000 Dated 24-11-
2017
Pharmacological Group SSRI
Type of Form Form-5

Me-too status Citanew by Hilton Pharma
GMP status GMP certificate issued based on inspection dated 15&
16th Jan, 2018 showed good compliance.
Remarks of Evaluator Firm has initially applied as:

Each film coated tablet contains:
Escitalopram oxalate….5mg
Now they corrected the composition with Rs.5000/ fee
Deposited (0796405) dated 16-11-2018.
Decision:
Applicant Lahore
Escitalopram Oxalate eq to Escitalopram..…10mg
2017
Type of Form Form-5

Me-too status Zavget10mg Tablets by Getz Pharma, Reg. No. 45279
Deposited (0796410) dated 16-11-2018.
Decision:
Applicant Lahore
Escitalopram Oxalate eq to Escitalopram..….20mg
2017
Type of Form Form-5

Me-too status Repram 20mg tablet of M/s Regal Pharma (Reg. #
081963)
Deposited (0796409) dated 16-11-2018.
Decision:
Applicant Lahore
Brand Name +Dosage Form + Strength Resert 50mg Tablets
Sertraline HCL eq to Sertraline……50mg
2017
Type of Form Form-5

Me-too status Zoloft Tablets 50mg of M/s Pfizer (Reg. # 020855)
Sertraline HCL…50mg
Deposited (0796408) dated 16-11-2018.
Decision:
Applicant Lahore
Brand Name +Dosage Form + Strength Resert 100mg Tablets
Sertraline HCL eq to Sertraline……100mg
2017
Type of Form Form-5

Me-too status Zoloft Tablets 100mg by M/s Pfizer (Reg.# 020856)
Sertraline HCL…100mg
Deposited (0796407) dated 16-11-2018.
Decision:
Applicant Lahore
Brand Name +Dosage Form + Strength Reflit 20mg Capsule
Composition Each Hard Gelatin Capsule Contains:
Fluoxetine HCL eq to Fluoxetine…20mg
2017
Type of Form Form-5

Approval status of product in Reference USFDA Approved

Me-too status Flufa 20mg Capsules of Farm Aid Group
Fluoxetine HCL…20mg Now they corrected the
composition with Rs.5000/ fee Deposited (0796406)
dated 16-11-2018.
Decision:
187. Name and address of manufacturer / M/s Medicraft Pharmaceuticals Pvt Ltd.
Applicant 126-B, Indstrial Estate, Hayatabad, Peshawar,
Pakistan
Brand Name +Dosage Form + Strength Riximid 200mg Tablet
Composition Each Film Coated tablet Contains:
Rifaximin…….200mg
2018
Type of Form Form-5
Finished product Specification Manfacturer’s

Me-too status Nixaf 200mg tablet of Sami Pharma (Reg#076310)
GMP status Last GMP Inspection conducted on 30-1-2018 with
conclusive remarks of cGMP compliance.
Remarks of Evaluator
Decision:
Pakistan
Brand Name +Dosage Form + Strength Riximid 550mg Tablet
Composition Each Film Coated tablet Contains:
Rifaximin…….550mg
2018
Type of Form Form-5

Me-too status Rixago 550mg Tablet by M/s OBS Pharma Karachi
(Reg#081073)
Decision:
Pakistan
Brand Name +Dosage Form + Strength Bestine-D 8mg Tablet
Composition Each Tablet Contains:
Betahistine Dihydrochloride……….8mg
2018
Pharmacological Group Anti-vertigo
Type of Form Form-5
Pack size & Demanded Price 3 x 10’s, As per SRO
Approval status of product in Reference TGA approved

Me-too status VR-Tigo Tablets 8mg by Himont Pharmaceuticals
(Pvt) Ltd. Reg. No. 79703
Decision:
Pakistan
Brand Name +Dosage Form + Strength Dasron 8mg/4ml Injection
Composition Each 4ml Ampoule Contains:
Ondansetron Hydrochloride….…8mg
2018
Pharmacological Group Serotonin type 3 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 4ml, As per SRO

Me-too status Zofran injection of M/s GSK (Reg. # 020669)
Remarks of Evaluator Salt factor is incorrect.
Decision:
Pakistan
Brand Name +Dosage Form + Strength Flupixol Depot 40mg/2ml
Flupentixol Decanoate…40mg
2018
Pharmacological Group Antipsychotic
Type of Form Form-5
Pack size & Demanded Price 2ml, As per SRO

Me-too status Luixol 40mg Depot Injection Reg # 068464
Remarks of Evaluator International availability could not be confirmed
Decision:
Pakistan
Brand Name +Dosage Form + Strength Telmi 40mg Tablet
Telmisartan…40mg
2018
Type of Form Form-5
Pack size & Demanded Price 2 x 7’s, As per SRO

Me-too status Tasmi 40mg tablet of M/s Getz Pharma (Reg. #
047482)
Decision:
Evaluator PEC-VII
193. Name and address of manufacturer / M/s Wellborne Pharmachem and Biologicals, Plot
Applicant No. 51/1, 52/2 phase I & II, Industrial Estate,
Hattar.
Brand Name +Dosage Form + Strength Linezomed 600 mg tablet
Composition Each film-coated tablet contains:
Linezolid ...................................600mg
Diary No. Date of R& I & fee D#43488, 3-Aug 2016; Rs. 20,000/- (Duplicate)
Pharmacological Group Macrolide (Antibiotics)
Form Form-5
3x4’s
Approval status of product in Zyvox 600 mg film-coated tablets by Pharmacia
Reference Regulatory Authorities Limited (MHRA Approved)
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals (Reg. #
066904)
and the report shows good GMP c.
Remarks of evaluator VII
Decision:
194. Name and address of manufacturer / M/S Epharm Laboratories, A-40, Road No.1,
Applicant S.I.T.E, Super Highway, Industrial Area, North
Karachi, Pakistan.
Brand Name +Dosage Form + Strength Ephanac 50 mg capsules

Composition Each enteric coated pellet filled capsule contains:
Diclofenac Sodium…50 mg
Diary No. Date of R& I & fee D#88 , Rs. 8,000/- (29-12-2010), 12000 (21-july-
2014), 80000/- (19-6-2018)
Pharmacological Group Antispasmodic/Anticholinergic
Type of Form Form-5
Finished product Specifications Innovators
Pack size & Demanded Price 10’s
As per SRO
Approval status of product in DIFENE 50 Milligram Capsules Gastro-Resistant
Reference Regulatory Authorities (Ireland)
Me-too status Lotofenac 50mg Capsule by Lotus Pharmaceuticals
Islamabad
GMP status 01/03/18
“Based on above observations and keeping in view
the attitude of the management towards the
continuous improvements their current level of
compliance was noted as satisfactory.”
Remarks of Evaluator VII Source of pellets is Zen biotech Telangana india.
Decision:
195. Name and address of manufacturer / M/S Biolabs (Pvt) Ltd, Plot # 145, Industrial
Applicant Triangle, Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Ferric-C 50mg/ml Injection

Dated 28-12-2017
Composition Each ml Contains:

Ferric Carboxymaltose…50mg
Type of Form Form-5
Finished Product Specification Innovators specifications
Pack Size & Demanded Price Type 1 glass.
2ml solution containing 100 mg iron
10 ml solution containing 500 mg iron
20 ml solution containing 1000 mg iron
As per SRO
Approval Status of Product in Reference Ferinject by Vifor Pharma (TGA)
Me-too Status Ferinject imported by M/s. RG Pharmaceutica (Pvt.)
Ltd.,Karachi.(R. No. 072548)
GMP status M/s Bio-Labs (Pvt.) Ltd., Islamabad was granted
GMP certificate based on inspection conducted on 5th
& 06th -12-2017.
Remarks of the Evaluator VII
Decision:
196. Name and address of manufacturer / M/S Biolabs (Pvt) Ltd, Plot # 145, Industrial
Brand Name +Dosage Form + Strength Voric 200mg Tablets

Dated 28-12-2017
Voriconazole…200mg
Type of Form Form-5
Pack Size & Demanded Price As per SRO
Approval Status of Product in Reference V-fend tablet of M/s Pfizer Pharma (UK)
Me-too Status Vorif tablets of M/s Ferozesons Laboratories

& 06th -12-2017
Decision:
197. Name and address of manufacturer / M/S Biolabs (Pvt) Ltd, Plot # 145, industrial
Brand Name +Dosage Form + Strength Epilepto-D 250mg Tablets

Dated 28-12-2017
Divalproex Sodium…250mg
Pharmacological Group Anticonvulsants & Anti-epileptics
Type of Form Form-5
Pack Size & Demanded Price 30’s
As per SRO
Approval Status of Product in Reference Divalproex Sodium delayed-release tablet (USFDA
Regulatory Authorities. Approved)
Me-too Status Epival tablet 250mg of M/s Abbott Laboratories (Reg.
# 007160)
& 06th -12-2017
Decision:
198. Name and address of manufacturer / M/s Lisko Pakistan Pvt Ltd. L-10-D, Block 21,
Applicant Shaheed Rashid Minhas Road, F.B. Industrial
Area, Karachi
Brand Name +Dosage Form + Strength Fulliron 800mg/15ml Dry Suspension
Dated 17-01-2018
Iron Protein Succinylate…800mg
Pharmacological Group Anti-Anemic
Type of Form Form-5
Finished Product Specification Innovator's Specs.
Pack Size & Demanded Price 30ml: 80 Rupees, 60ml:160 rupees, 90ml:220
rupees, 100ml:250 rupees, 120ml: 300 rupees.
Approval Status of Product in Reference
Regulatory Authorities. N/A
Me-too Status
Follinemic suspension by Epharm Labs (Reg #
044349)
GMP status Latest inspection dated 24-04-2018
Conclusion:
“Based on current inspection, documents reviewed it
was noted that firm is currently working under
satisfactory level of cGMP compliance.
(Show cause notice revoked on 27-04-2018)”
Remarks of the Evaluator VII Firm has requested to change the formulation to
Liquid
Each 15ml contains:
Iron Protein Succinylate 800mg equivalent to
elemental Iron … 40mg
Firm has also submitted fee PKR 5,000/- (Chalan No.
0747452) for change in formulation
Decision:
Evaluator PEC-VIII
199. Name and address of Manufacturer / M/s Barrett Hodgson Pakistan (Private) Limited.
Applicant
Brand Name + Dosage Form + Strength Baritral SR tablet 100mg
Composition Each sustained release film coated tablet contains:
Tramadol hydrochloride…. 100mg
Diary No. Date of R&I & fee DyNo.3972; 31-01-2018; Rs. 20,000/-
Pharmacological Group Analgesic
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 10’s: Rs. 320/- Or As per SRO
Regulatory Authorities
Me-too status Zultra SR 100mg tablet of M/s. Wilshire Laboratories
(Pvt) Ltd
GMP status Panel inspection conducted on 19-09-17 unanimously
recommended grant of cGMP Certificate.
Decision:
Applicant
Brand Name + Dosage Form + Strength Fidaxo tablet 30mg
Fexofenadine hydrochloride…. 30mg
Pharmacological Group Antihistamine
Type of Form Form-5
Approval status of product in Reference Approved in MHRA
Me-too status Fexinol Tablets 30mg of Martin Dow Pharmaceuticals
Decision:
Applicant
Type of Form Form-5
Me-too status Telfast Tablets 120mg of Hoechst Marion Roussel
Decision:
Applicant
Type of Form Form-5
Me-too status Telfast Tablets 120mg of Hoechst Marion Roussel
GMP status GMP inspection conducted on 08-08-17 concluded that
firm is operating at satisfactory level of GMP
compliance.
Decision:
203. Name and address of Manufacturer / M/s Unexolabs (Private) Limited, Fine chemical &
Applicant Pharmaceuticals Manufacturer’s
Brand Name + Dosage Form + Strength Uvastin tablet 10mg
Rosuvastatin (as calcium) …. 10mg
Type of Form Form-5
Pack Size & Demanded Price 10’s: Or As per SRO
Me-too status Lolipid Tablets 10mg of Alliance Pharmaceuticals.
firm is has shown positive approach towards compliance
of GMP advices given for further up gradation.
Decision:
Type of Form Form-5
Me-too status Could not be confirmed
Remarks of Evaluator  Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status)
alongwith registration number, brand name and
name of firm.
Decision:
Type of Form Form-5
Me-too status Lolipid Tablets 20mg of Alliance Pharmaceuticals.
Decision:
Brand Name + Dosage Form + Strength Umrazole-20 Plus Capsule
Omeprazole…20mg
Sodium Bicarbonate…1100mg
Pharmacological Group PPIs/Antacid
Type of Form Form-5
Pack Size & Demanded Price 2×7’s: Or As per SRO
Me-too status Omsod 40 mg Capsules ofReliance Pharma
Decision:
Brand Name + Dosage Form + Strength Umrazole-40 Plus Capsule
Omeprazole…40mg
Type of Form Form-5
Pack Size & Demanded Price 2×7’s: Or As per SRO
Me-too status Omsod 20 mg Capsules ofReliance Pharma
Decision:
208. Name and address of Manufacturer / M/s Genix Private Limited, 44, 45-B Koangi Creek
Applicant Road, Karachi.
Brand Name + Dosage Form +Strength Mep-B Insta 20mg/1680

Omeprazol…20mg
Sodium bicarbonate…1680mg
Type of Form Form-5
Pack Size & Demanded Price 10’s ; As per SRO
Approval status of product in Reference Approved in USFDA
Me-too status RisekInsta Sachet 20mg/1680mg of Getz Pharma.
GMP status GMP Inspection conducted on 08-08-2017 concluded
that firm is operating at satisfactory level of GMP
compliance.
Decision:
209. Name and address of Manufacturer / M/s Genix Private Limited, 44, 45-B Koangi Creek
Applicant Road, Karachi.
Brand Name + Dosage Form +Strength Mep-B Insta 40mg/1680

Omeprazol…40mg
Sodium bicarbonate…1680mg
Type of Form Form-5
Me-too status RisekInsta Sachet 40mg/1680mg of Getz Pharma.
compliance.
Decision:
210. Name and address of Manufacturer / M/s Sami Pharmaceuticals Pvt Limited.
Applicant F-95, S.I.T.E, Karachi, Pakistan
Brand Name + Dosage Form + Strength Co-Sevia Tablet 5mg/160mg/25
Amlodipine(as besylate)…5mg
Valsartan…..160mg
Hydrochlorothiazide…25mg
Calcium antagonist/Angiotensin II
antagonist/Diuretic
Type of Form Form-5
Me-too status Valtec AMH 5/160/25 Tablet of Tabros Pharma
Karachi
GMP status Certificate of cGMP is issued to the firm based on
evaluation conducted on 14-06-218 with following
sections:
1- Oral Liquid Syrup/suspension/drops/dry powder
suspension (Gen/Gen Antibiotic).
2- Granualtion/Pelletization/taste masking (Gen/Gen
Antibiotic).
3- Liquid Injectable-LVP (Gen/Gen Antibiotic).
4- Tablet/Capsule/Sachet (Gen/Gen Antibiotic).
5- Liquid Freeze Dried Injectable-SVP (Gen/Gen
Antibiotic).
6- Tablet(Hormone)
7- Gel/Cream/Ointment (Gen/Gen Antibiotic).
8- Tablet/Capsule/Liquid Injectable (Psychotropic).
Decision:
Brand Name+DosageForm+Strength Co-Sevia Tablet 5 mg/160mg/12.5mg
Valsartan…..160mg
Hydrochlorothiazide…12.5mg
antagonist/Diuretic
Type of Form Form-5
Me-too status Tri-Velker Tablet 5/160/12.5 Tablet of High-Q
Karachi
sections:
Antibiotic).
Antibiotic).
6- Tablet(Hormone)
Decision:
Brand Name + Dosage Form + Strength Co-Sevia tablet 10 mg/160mg/12.5mg
Valsartan…..160mg
Hydrochlorothiazide…12.5mg
antagonist/Diuretic
Type of Form Form-5
Me-too status Valtec AMH 10/160/12.5 Tablet of Tabros Pharma
Karachi
sections:
Antibiotic).
Antibiotic).
6- Tablet(Hormone)
Decision:
Brand Name + Dosage Form + Strength Co-Sevia tablet 10 mg/160mg/25mg
Valsartan…..160mg
antagonist/Diuretic
Type of Form Form-5
Karachi
sections:
Antibiotic).
Antibiotic).
6- Tablet(Hormone)
Decision:
Brand Name + Dosage Form + Strength Co-Sevia tablet 10 mg/320mg/25mg
Valsartan…..320mg
antagonist/Diuretic
Type of Form Form-5
Karachi
sections:
2- Granualtion/Pelletization/taste masking
(Gen/Gen Antibiotic).
Antibiotic).
6- Tablet(Hormone)
Decision:
215. Name and address of Manufacturer / M/s Welmark Pharmaceuticals Plot # 122, Block-B,
Applicant Phase-V, Industrial Estate Hattar.
Brand Name + Dosage Form + Strength Weltriptan tablet 40mg
Eletriptan hydrobromide…. 40mg
Diary No. Date of R&I & fee Dy.No.3983;31-01-18: Rs. 20,000
Pharmacological Group Anti-Migraine
Type of Form Form 5
Me-too status Relpax 40mg Tablets of Pfizer Laboratories Ltd.
period of one year.
Remarks of Evaluator Reference product is approved as Eletriptan (as
hydrobromide) 40mg film coated tablet which is
different from that of applied formulation i.e.
Eletriptan hydrobromide 40mg uncoated tablet.
Submit Form 5, master formulation & manufacturing
method in line with reference product.
Monograph for test/analysis of applied formulation is
not present in available USP/BP.
Decision:
Brand Name + Dosage Form + Strength Weltriptan tablet 20mg
Eletriptan hydrobromide…. 20mg
Diary No. Date of R&I & fee Dy.No.3982;31-01-18: Rs. 20,000
Pharmacological Group Anti-Migraine
Type of Form Form 5
Me-too status Elle Tablets 20mg of M/s Wilshire Laboratories.
period of one year.
Remarks of Evaluator Reference product is approved as Eletriptan (as
hydrobromide) 20mg film coated tablet which is
different from that of applied formulation i.e.
Eletriptanhydrobromide 20mg uncoated tablet.
Submit Form 5, master formulation & manufacturing
method in line with reference product.
Monograph for test/analysis of applied formulation is
not present in available USP/BP.
Decision:
Brand Name + Dosage Form + Strength Welpure tablet 300mg
Allopurinol…. 300mg
Diary No. Date of R&I & fee Dy.No.3981; 31-01-18: Rs. 20,000
Pharmacological Group Anti-Gout
Type of Form Form 5
Finished Product Specification BP Specifications
Me-too status Zyuric-300 Tablet of M/s Rasco Pharma
period of one year.
Decision:
218. Name and address of Manufacturer / Previously Wellness Pharmaceuticals Plot # 33
Applicant Sundar Industrial Estate Lahore.
Now:
M/s Horizon Healthcare (Pvt Ltd.
Plot # 33, Sundar Industrial Estate Lahore.
Brand Name + Dosage Form + Strength NEBULA Tablets 10mg
Nebivolol…10mg
Diary No. Date of R&I & fee Dy No. 6141 ; 19-02-18: Rs.20,000
Pharmacological Group Beta blocker
Type of Form Form 5
Finished Product Specification Innovator
Pack Size & Demanded Price 10’s: As per SRO
Me-too status Nebil 10mg Tablet of Getz Karachi
compliance.
Remarks of Evaluator Reference product in approved as uncoated tablet but
you have applied with coating. 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
coated tablet.
Applicant has submitted the fee challan of Rupee Rs.
20,000 dated 08th of January, 2019 in the name of
Decision:
219. Name and address of Manufacturer / Previously Wellness Pharmaceuticals Plot # 33
Applicant Sundar Industrial Estate Lahore.
Now:
Brand Name + Dosage Form+ Strength NEBULA Tablets 5mg
Nebivolol…5mg
Type of Form Form 5
compliance.
Remarks of Evaluator Reference product in approved as uncoated tablet but
you have applied with coating. 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
coated tablet.
Applicant has submitted the fee challan of Rupee Rs.
20,000 dated 08th of January, 2019 in the name of
Decision:
220. Name and address of Previously Wellness Pharmaceuticals Plot # 33 Sundar Industrial
Manufacturer/Applicant Estate Lahore.
Now:
Brand Name + Dosage Form + NEBULA Tablets 2.5mg
Strength
Nebivolol…2.5mg
Diary No. D of R & I & Fee Dy No. 6139 ; 19-02-18: Rs.20,000
Pharmacological group Beta blocker
Type of Form Form 5
Finished product Specifications Innovator
Pack Size & demanded price 10’s: As per SRO
Approval status of product in Approved in US-FDA
reference regulatory authorities
Me-too status Nebil 2.5mg Tablet of Getz Karachi
GMP Status GMP Inspection conducted on 12-12-2017 concluded that firm is
operating at satisfactory level of GMP compliance.
Remarks of Evaluator Reference product in approved as uncoated tablet but you have
applied with coating. 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 coated tablet.
Applicant has submitted the fee challan of Rupee Rs. 20,000
dated 08th of January, 2019 in the name of M/s Horizon
Healthcare (Pvt Ltd.
Decision:
Now:
Brand Name + Dosage Form + DANZSTINE Tablets 8mg
Strength
Betahistine dihydrochloride…8mg
Pharmacological group Anti-vertigo
Type of Form Form 5
Finished product Specifications USP Specifications
Pack Size & demanded price 30’s, 60’s, 100’s, : As per SRO
Approval status of product in Approved in MHRA
Me-too status Betalin Tablet 8mg of M/s Linear Parma
Remarks of Evaluator Applicant has submitted the fee challan of Rupee Rs. 20,000
Decision:
Now:
Strength
Betahistine dihydrochloride …16mg
Pharmacological group Anti-vertigo
Type of Form Form 5
Pack Size & demanded price 30’s, 60’s, 100’s : As per SRO
Me-too status Betalin Tablet 16mg of M/s Linear Parma
Decision:
Now:
Strength
Betahistine dihydrochloride ….24mg
Pharmacological group Anti vertigo
Type of Form Form 5
Pack Size & demanded price 30’s, 60’s, 100’s: As per SRO
Me-too status Serc 24mg tablet of M/s Abbott Pakistan
Decision:
Now:
Brand Name + Dosage Form + LIPTIN Tablets 25mg
Strength
Sitagliptin …25mg
Pharmacological group Anti-diabetic
Type of Form Form 5
Pack Size & demanded price 10’s, 30’s: As per SRO
Me-too status Duvel 25mg Tablet of Martin Dow
Remarks of Evaluator Reference product in approved as Sitagliptin (as phosphate
monohydrate) 25mg tablet but you have applied for Sitagliptin
25mg 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 Sitagliptin
25mg tablet.
Decision:
Now:
Strength
Sitagliptin …50mg
Diary No. D of R & I & Fee Dy No. 6131; 19-02-18: Rs.20,000
Type of Form Form 5
50mg 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 Sitagliptin
50mg tablet.
Decision:
Now:
Brand Name + Dosage Form + Solicept Tablets 5mg
Strength
Solifenacin Succinate…5mg
Pharmacological group Anticholinergic
Type of Form Form 5
Me-too status Fenaso 5mg of M/s Highnoon
Decision:
Now:
Brand Name + Dosage Form + Solicept Tablets 10mg
Strength
Solifenacin Succinate…10mg
Pharmacological group Anticholinergic
Type of Form Form 5
Me-too status Fenaso 10mg of M/s Highnoon
Decision:
Now:
Brand Name + Dosage Form + ITON Tablets 50mg
Strength
Itopride hydrochloride…50mg
Pharmacological group Gastrokinetic
Type of Form Form 5
Pack Size & demanded price 10’s,30’s: As per SRO
Approval status of product in Approved in PMDA
Me-too status Ganaton by M/s Abbott Pakistan
Remarks of Evaluator Reference product in approved as film coated tablet but you have
applied for uncoated tablet. Submit form 5, master formulation &
as uncoated tablet.
Decision:
Now:
Brand Name + Dosage Form + ITON Tablets 150mg
Strength
Itopride hydrochloride …150mg
Type of Form Form 5
Approval status of product in Ganaton by Abbott USA
Me-too status Ganaton by M/s Abbott Pakistan
Remarks of Evaluator Evidence of approval of applied formulation i.e. Itopride
hydrochloride 150mg uncoated tablet in reference regulatory
authorities/agencies which were declared/approved by the
Registration Board in its 275th meeting.
Decision:
Now:
Brand Name + Dosage Form + ITON Capsule 50mg
Strength
Itopride hydrochloride …50mg
Type of Form Form 5
Approval status of product in Ganaton by Abbott USA (as provided by the firm)
Me-too status Ganaton by M/s Abbott Pakistan (as provided by the firm)
Remarks of Evaluator Evidence of approval of applied formulation i.e. Itopride
hydrochloride 50mg capsule in reference regulatory
Decision:
Now:
Brand Name + Dosage Form + Roxab Tablets 10mg
Strength
Rivaroxaban…10mg
Pharmacological group Anticoagulant
Type of Form Form 5
Approval status of product in Xarelto by BAYER Germany
Me-too status Xarelto by M/s Bayer Pakistan
Decision:
Now:
Strength
Rivaroxaban…15mg
Type of Form Form 5
Decision:
Now:
Strength
Rivaroxaban…20mg
Type of Form Form 5
Decision:
Now:
Strength
Sitagliptin …100mg
Type of Form Form 5
100mg tablet. Submit form 5, master formulation &
as Sitagliptin 100mg tablet.
Decision:
R-V vides its letter No. F.8-6/2013-Reg-V dated 21stof January, 2019forwarded two original dossiers of
below mentioned products of Nova-Med Pharma, Lahore for Evaluation having following information on
the letter.
Sr. Name of drug(s) with composition Date of submission of
N. Name of firm fee
1. M/s Novamed Each 3 ml ampoule Contains: Dy. No. 8933
Pharma, Lahore. Thiamine hydrochloride…100mg Dated 17-07-2017
Pyridoxine hydrochloride…
100mg
Cyanocobalamin…. 1000mcg
2. M/s Novamed Nuphine injection 10mg/ml Dy. No. 12496
Pharma, Lahore. Each ml ampoule Contains: Dated 18-08-2017
Nalbuphine hydrochloride….
10mg
235. Name and address of M/s Novamed Pharma, Lahore.
Manufacturer/Applicant
Brand Name + Dosage Form + Nerin- B Ampoule
Strength
Composition Each 3 ml ampoule Contains:
Thiamine hydrochloride…100mg
Pyridoxine hydrochloride… 100mg
Cyanocobalamin…. 1000mcg
Pharmacological group Vitamin Supplement
Type of Form Form 5
Finished product Specifications Manufacturer’s Specifications
Approval status of product in Approved in Germany (as provided by the firm)
Me-too status Neurobion of Martin Dow (001486) (pharmaguide)
GMP Status GMP Certificate issued on 03-01-2018 with following sections:
1- Tablet section( Non Antibiotic, Antibiotic & Psychotropic)
2- Capsule Section (Non Antibiotic, Antibiotic & Cephalosporin)
3- Oral Liquid section (Non Antibiotic)
4- Dry powder for oral suspension section(Non Antibiotic,
Antibiotic & Cephalosporin)
5- Liquid Inject able section (Vial and Ampoule) (Non Antibiotic,)
6- Dry powder inject able section (Cephalosporin)
7- Cream/ Ointment / Gel (General)
8- Eye Drops (General)
9- Tulle Dressing (General).
Decision:
236. Name and address of M/s Novamed Pharma, Lahore.
Manufacturer/Applicant
Brand Name + Dosage Form + Nuphine injection 10mg/ml
Strength
Composition Eachml ampoule Contains:
Nalbuphine hydrochloride…. 10mg
Pharmacological group Opioid Analgesic
Type of Form Form 5
Finished product Specifications Manufacturer’s Specifications
Pack Size & demanded price 5’s(1ml): As per SRO
Me-too status Neurobionof Martin Dow (001486) (pharmaguide)
GMP Status GMP Certificate issued on 03-01-2018 with following sections:
1- Tablet section( Non Antibiotic, Antibiotic & Psychotropic)
2- Capsule Section (Non Antibiotic, Antibiotic & Cephalosporin)
3- Oral Liquid section (Non Antibiotic)
4- Dry powder for oral suspension section(Non Antibiotic,
Antibiotic & Cephalosporin)
5- Liquid Inject able section (Vial and Ampoule) (Non Antibiotic,)
6- Dry powder inject able section (Cephalosporin)
7- Cream/ Ointment / Gel (General)
8- Eye Drops (General)
9- Tulle Dressing (General).
Remarks of Evaluator Applied formulation is not present in USP & B.P.
Step of terminal sterilization has not been mentioned in
manufacturing outline. Clarify or justify the same.
Mention type of primary packaging material of applied
formulation.
Decision:
237. Name and address of manufacturer/ M/s Medizan Laboratories Limited.
Applicant
Brand Name +Dosage Form+ P-Nec XR 12.5mg Tablets
Strength
Diary No. Date of R&I &fee DiaryNo:6123; 19/02/2018; Rs:20,000/-
Composition Each enteric film coated extended release tablet contains:
Paroxetine (as hydrochloride) …12.5mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Finished Product Specification USP specification
Pack size &Demanded Price 10’s, 30’s, ;As Per SRO
Approval status of product in Approved in USFDA
Me-too status Deroxat CR tablet 12.5mg by Global Pharma
GMP status GMP Inspection conducted on 20-11-2017 concluded that
firm is operating at satisfactory level of GMP Compliance.
Remarks of the Evaluator. Submit manufacturing method in line with reference
product.
Decision:
238. Name and address of manufacturer/ M/s Medizan Laboratories Limited.
Applicant
Brand Name +Dosage Form+ P-Nec XR 25mg Tablets
Strength
Diary No. Date of R&I &fee DiaryNo:6124; 19/02/2018; Rs:20,000/-
Composition Each enteric film coated extended release tablet
contains:Paroxetine (as hydrochloride) …25mg
Type of Form Form-5
Pack size &Demanded Price 10’s, 30’s;As Per SRO
Me-too status Deroxat CR tablet 25mg by Global Pharma
Remarks of the Evaluator. Submit manufacturing method in line with reference
product.
Decision:
R-II vides its letter No. F.6-10/2013-Reg-II dated 21thof June, 2018,forwarded one duplicate dossier of below
mentioned product of Macquin’s International, Karachi for further action if the case has already not been
considered.
Sr. Name of drug(s) with Date & diary number Remarks
N. Name of firm composition
1. M/s. Macquin’s Ocu-Drozol Eye drop (5ml) Dy. No. Nill Duplicate
International, Each ml contains: 06-06-2016 dossier
Karachi Dorzolamide (as Form 5
hydrochloride)….. 20mg Rs. 20,000
Timolol (as maleate)…. 5mg 06-06-2016
(Duplicate)
Evaluation by PEC:The case of applied formulation has not been found registered with the name of firm as per
record available with us till to date so the case has been evaluated and placed inside the agenda for the
consideration of the worthy Registration Board.
239. Name and address of manufacturer/ M/s. Macquin’s International, Karachi
Applicant
Brand Name +Dosage Form+ Ocu-Drozol Eye drop (5ml)
Strength
Diary No. Date of R&I &fee DiaryNo: duplicate dossier
Dorzolamide (as hydrochloride)….. 20mg
Timolol (as maleate)…. 5mg
Pharmacological Group Anti-gluocoma
Type of Form Form-5
Pack size &Demanded Price 5ml : As Per SRO
Me-too status Dorlol Dye Drops of Genix Karachi
Remarks of the Evaluator. Submit manufacturing method & master formulation
Decision:
Evaluator PEC-IX
240. Name and address of Polyfine Chempharma, 51-Industrial Estate, Hayatabad
manufacturer / Applicant Peshawar Pakistan
Brand Name +Dosage Form Proton 50 mg Tablet
+ Strength
Itopride HCl…..50mg
Diary No. Date of R& I & Dy No. 6898: 22.02.2018
fee PKR 20,000/-: 22.02.2018
Pharmacological Group Drugs for functional gastrointestinal disorders
Type of Form Form 5
Finished Product The firm has claimed manufacturer’s specifications
Specification
Pack size & Demanded 3x10’s; as per SRO
Price
Approval status of product Itopride hydrochloride tablet 50 mg. PMDA approved
in Reference Regulatory
Authorities.
Me-too status Itoride Tablet. Reg No. 42040
GMP status The firm was inspected on 17.03.2017 wherein the GMP was rated
satisfactory.
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 provided
acceptance limits/criteria only.
 The brand name shall be changed.
 Decision:
Brand Name +Dosage Form Fission 50 mg Tablet
+ Strength
Clomiphene citrate…..50mg
fee PKR 20,000/-: 22.02.2018
PKR 5000/-: 04.02.2019
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form 5
Finished Product USP
Specification
Price
Approval status of product Clomid™ 50mg Tablets. MHRA approved
Authorities.
Me-too status Gynofen 50mg Tablet. Reg No. 53337
satisfactory.
Remarks of the Evaluator.  The firm revised the formulation to plain tablet with submission
of Rs. 5000/-.
 The brand name shall be changed.
 Decision:
Brand Name +Dosage Form Glip-Met Tablet 50/500mg
+ Strength
Sitagliptin (as phosphate monohydrate)…50mg
Metformin HCl…….500mg
fee PKR 20,000/-: 22.02.2018
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form 5
Specification
Price
Approval status of product JANUMET® (sitagliptin and metformin HCl) tablet, 50/500mg film-
in Reference Regulatory coated. USFDA approved
Authorities.
Me-too status Neoglip 50/500mg Tablets. Reg. No. 53099
satisfactory.
Remarks of the Evaluator.  The firm revised Sitagliptin (as phosphate) to Sitagliptin (as
phosphate, monohydrate) in label claim.
 The firm was asked to provide complete finished product
specifications (list of tests, reference to analytical procedures, and
proposed acceptance criteria). However, the firm provided
 Decision:
Brand Name +Dosage Form Glip-Met Tablet 50/1000mg
+ Strength
Sitagliptin (as phosphate)…50mg
Metformin HCl…….1000mg
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Approval status of product JANUMET® (sitagliptin and metformin HCl) tablet, 50/1000mg
in Reference Regulatory film-coated. USFDA approved
Authorities.
Me-too status Neoglip 50/1000mg Tablets. Reg. No. 53100
satisfactory.
Remarks of the Evaluator.  The firm revised Sitagliptin (as phosphate) to Sitagliptin (as
phosphate, monohydrate) in label claim.
 The firm was asked to provide complete finished product
 Decision:
Brand Name +Dosage Form Zyrova Tablet 20mg
+ Strength
Rosuvastatin as calcium…20mg
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Approval status of product Crestor 20mg film-coated tablets. MHRA approved
Authorities.
Me-too status Rostat 20mg Tablet. Reg. No. 55731
satisfactory.
 Decision:
+ Strength
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Authorities.
satisfactory.
 Decision:
+ Strength
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Authorities.
satisfactory.
 Decision:
Brand Name +Dosage Form Roger Tablet 5/160/12.5mg
+ Strength
Amlodipine as besylate…5mg
Valsartan…..160mg
Hydrochlorthiazide……12.5
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Approval status of product EXFORGE HCT® Tablets by Novartis Pharmaceuticals
in Reference Regulatory Corporation. US-FDA approved
Authorities.
Me-too status Exforge HCT 5/160/12.5MG film coated tablets by Novatris
th
| 124
Pharma. Reg. No. 69548
satisfactory.
Remarks of the Evaluator. The brand name shall be changed.
 Decision:
Brand Name +Dosage Form Roger Tablet 10/160/12.5mg
+ Strength
Amlodipine as besylate…10mg
Valsartan…..160mg
Hydrochlorthiazide……12.5
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Approval status of product EXFORGE HCT® Tablets by Novartis Pharmaceuticals
in Reference Regulatory Corporation. US-FDA approved
Authorities.
Me-too status Exforge HCT 10/160/25MG film coated tablets by Novatris Pharma.
Reg. No. 69551
satisfactory.
Remarks of the Evaluator.  The brand name shall be changed.
 Decision:
Brand Name +Dosage Form Vilda-Met 50/500mg
+ Strength
Vildagliptin…50mg
Metformin HCl…..500mg
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Finished Product The firm has claimed manufacturer’s specifications.
Specification
Price
Approval status of product GALVUMET 50/500 vildagliptin 50 mg/metformin hydrochloride
in Reference Regulatory 500 mg film coated tablet. TGA approved
Authorities.
Me-too status Galmet 50mg/500mg Tablet. Reg No. 81905
satisfactory.
 The approved shelf-life of the product in 18 months in TGA
Australia
 Decision:
+ Strength
Vildagliptin…50mg
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Authorities.
Me-too status Valiant-M Tablets. Reg No. 77485
satisfactory.
Australia
 Decision:
+ Strength
Vildagliptin…50mg
fee PKR 20,000/-: 22.02.2018
Type of Form Form 5
Specification
Price
Authorities.
Me-too status Galmet 50mg/850mg Tablet. Reg No. 81906
satisfactory.
Australia
 Decision:
Brand Name +Dosage Form Hist Tablet 16mg
+ Strength
Betahistine dihydrochloride…16mg
fee PKR 20,000/-: 22.02.2018
Pharmacological Group Antivertigo preparations
Type of Form Form 5
Finished Product BP
Specification
Price
Approval status of product Betahistine 16 mg uncoated tablets. MHRA approved
Authorities.
Me-too status Histogen 16mg Tablets. Reg. No. 56092
satisfactory.
Remarks of the Evaluator. 
 Decision:
Brand Name +Dosage Form Uric-Cure Tablet 80mg
+ Strength
Febuxostat……80mg
fee PKR 20,000/-: 22.02.2018
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form 5
Specification
Price
Approval status of product ULORIC (febuxostat) tablet for oral use. USFDA approved
Authorities.
Me-too status Febulos 80mg Tablet. Reg. No. 82695
satisfactory.
 Decision:
Brand Name +Dosage Form Uric-Cure Tablet 40mg
+ Strength
Febuxostat……40mg
fee PKR 20,000/-: 22.02.2018
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form 5
Specification
Price
Approval status of product ULORIC (febuxostat) tablet for oral use. USFDA approved
Authorities.
Me-too status Febulos 40mg Tablet. Reg. No. 82694
satisfactory.
 Decision:
Evaluator PEC-XII
255. Name and address of manufacturer / M/s Gulf Pharmaceuticals, Plot # 49, Street # S-5,
Applicant National industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Sitatin-P 50 Tablet
Diary No. Date of R& I & fee Form-5 Dy.No 5445 dated 14-02-2018 Rs. 20,000/-
Dated 14-02-2018
Composition Each film-coated tablet Contains:
Sitagliptin (as phosphate monohydrate) …50mg
Pharmacological Group Dipeptidyl peptidase 4 (DPP-4) inhibitors
Type of Form Form-5
Pack size & Demanded Price 14’s/ As per SRO
Approval status of product in Reference JANUVIA 50 mg film-coated tablet by M/s Merck
Regulatory Authorities. Sharp Dohme (USFDA Approved)
Me-too status A-Glip 50mg Tablets by M/s Atco (Reg#053097)
GMP status Last GMP inspection conducted on 02-2-2018 & 07-2-
2018, and report concludes recommendation for
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Telsar-AM Tablet 5/80mg
Dated 14-02-2018
Amlodipine (as besylate) …5mg
Telmisartan …80mg.
Pharmacological Group Angiotensin II antagonists and calcium channel
blockers
Type of Form Form-5
Approval status of product in Reference Telmisartan and amlodipine tablet 5mg/80mg by M/s
Regulatory Authorities. Mylan Pharmaceuticals Inc. (USFDA approved)
Me-too status Telsarta-A 5/80 Tablet by M/s Pharmevo
(Reg#073762)
renewal of DML.
Remarks of the Evaluator.  In reference regulatory authorities like in EMA
and USFDA the applied drug is multi-layered
tablet, firm has not applied drug as multi layered
tablet.
 Firm has not submitted evidence of double layer
compression machine.
Decision:
Dated 14-02-2018
blockers
Type of Form Form-5
Approval status of product in Reference Not confirmed
Me-too status Not confirmed
renewal of DML.
tablet.
 Approval status of product in Reference
Regulatory Authorities not confirmed.
 Me-too status not confirmed from available
database.
Decision:
Brand Name +Dosage Form + Strength Telsar-80 Tablet
Dated 14-02-2018
Telmisartan…80mg
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain
Type of Form Form-5
Approval status of product in Reference Telmark 80mg film-coated tablets by M/s Glenmark
Regulatory Authorities. Pharmaceuticals s.r.o (MHRA Approved)
Me-too status Tesart 80mg Tablets by M/s 'Bosch (Reg#045083)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength BP-Ril-20 Tablet
Dated 14-02-2018
Lisinopril (as dihydrate) …20mg
Pharmacological Group ACE inhibitors, plain
Type of Form Form-5
Approval status of product in Reference LISINOPRIL 20mg TABLETS by M/s Actavis UK
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Zestril tablets 20mg by M/s ICI (Reg#012352)
renewal of DML.
Decision:
Dated 14-02-2018
Type of Form Form-5
Approval status of product in Reference JANUVIA 100mg film-coated tablet by M/s Merck
Regulatory Authorities. Sharp Dohme (USFDA Approved)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Sitatin-Plus Tablet 25/500mg
Dated 14-02-2018
Metformin hydrochloride …500mg
Type of Form Form-5
Finished Product Specification Manufacturer’s specifications
Approval status of product in Reference Not confirmed.
Me-too status Sitaglu Met Tablets 25/500 by M/s Hilton
(Reg#073734)
renewal of DML.
Remarks of the Evaluator.  Approval status of product in Reference
Decision:
Brand Name +Dosage Form + Strength Sitatin-Plus Tablet 25/1000mg
Dated 14-02-2018
Metformin hydrochloride …1000mg
Type of Form Form-5
renewal of DML.
database.
Decision:
Dated 14-02-2018
Telmisartan…20mg
Type of Form Form-5
Approval status of product in Reference Telmisartan STADA 20 mg film-coated tablets by M/s
Regulatory Authorities. STADA Arzneimittel AG (Swedish Medical Producta
Agency Approved)
Me-too status Mycardix 20mg Tablets by M/s Macter (Reg#044215)
renewal of DML.
Decision:
Dated 14-02-2018
Telmisartan…40mg
Type of Form Form-5
Approval status of product in Reference Telmisartan STADA 40 mg film-coated tablets by M/s
Regulatory Authorities. STADA Arzneimittel AG (Swedish Medical Producta
Agency Approved)
Me-too status Mycardix 40mg Tablets by M/s Macter (Reg#044216)
renewal of DML.
Decision:
Dated 14-02-2018
Type of Form Form-5
Approval status of product in Reference Sitagliptin APOTEX 25 mg tablet by M/s Apotex Pty
Regulatory Authorities. Ltd (TGA Approved)
renewal of DML.
Decision:
Dated 14-02-2018
Lisinopril (as dihydrate) …10mg
Type of Form Form-5
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Amsatin Tablet 5/80mg
Dated 14-02-2018
Amlodipine (as Besylate)…5mg
Valsartan…80mg
blockers
Type of Form Form-5
Approval status of product in Reference Amlodipine/Valsartan 5 mg/80 mg film-coated tablets
Regulatory Authorities. by M/s Genus Pharmaceuticals Ltd (MHRA
Approved)
Me-too status Exforge 5/80mg film coated tablets by M/s Novartis
Pharma (Pakistan) Limited (Reg#047569)
renewal of DML.
Decision:
Dated 14-02-2018
blockers
Type of Form Form-5
(Reg#073763)
renewal of DML.
tablet.
Decision:
Dated 14-02-2018
blockers
Type of Form Form-5
(Reg#073767)
renewal of DML.
tablet.
Decision:
Dated 14-02-2018
Lisinopril (as dehydrate) …20mg
Type of Form Form-5
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Lostan-K25 Tablet
Dated 14-02-2018
Type of Form Form-5
Approval status of product in Reference Klomentan 25 mg film-coated tablets. By M/s Amneal
Regulatory Authorities. Pharma Europe Limited (Sweden Approved)
Me-too status Pixan-25 Tablets by M/s Medipak (Reg#023943)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Lostan-K50 Tablet
Dated 14-02-2018
Losartan potassium …50mg
Type of Form Form-5
Approval status of product in Reference Losartan Potassium 50 mg Film-coated Tablets. By
Regulatory Authorities. M/s Cadila Pharmaceuticals (MHRA Approved)
Me-too status Pixan-50 Tablets by M/s Medipak (Reg#023944)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Vildatin-Plus Tablet 50/500mg
Dated 14-02-2018
Vildagliptin…50mg
Metformin Hydrochloride…850mg
Type of Form Form-5
Pack size & Demanded Price 14’s /As per SRO
Approval status of product in Reference GALVUMET 50/500 mg film coated tablet by M/s
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Ltd (TGA
Approved)
Me-too status Galvus Met 50/500MG tablets by M/s Novartis
(Reg#078106)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Vildatin-Plus Tablet 50/850
Dated 14-02-2018
Vildagliptin…50mg
Type of Form Form-5
Approval status of product in Reference GALVUMET 50/850 mg film coated tablet by M/s
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Ltd (TGA
Approved)
Me-too status Glavimet 50/850mg Tablet by M/s Atco
(Reg#073496)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Guflinz 600mg Tablets
Dated 14-02-2018
Linezolid…600mg
Pharmacological Group Oxazolidinone antibacterial
Type of Form Form-5
Approval status of product in Reference Zyvox 600 mg film-coated tablets by M/s Pharmacia
Regulatory Authorities. Limited, (MHRA approved.)
Me-too status Ecasil 600mg tablet by M/s Sami (Reg#066904)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Guflinz 100mg/5ml Dry Powder Suspension
Dated 14-02-2018
Composition After reconstitution Each 5ml contains:
Linezolid…100mg
Type of Form Form-5
Approval status of product in Reference Zyvox 100 mg/5 ml granules for oral suspension by
Regulatory Authorities. M/s Pharmacia Limited (MHRA Approved)
Me-too status Lizotek Oral Suspension 100mg/5ml by M/s
TabrosPharma (Reg#057941)
GMP status
Decision:
Dated 14-02-2018
Valsartan…160mg
blockers
Type of Form Form-5
Approval status of product in Reference Amlodipine/Valsartan 10 mg/160 mg film-coated
Regulatory Authorities. tablets by M/s Genus Pharmaceuticals Ltd (MHRA
Approved)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Erotine 150mg Capsule
Dated 14-02-2018
Erdosteine…150mg
Pharmacological Group Mucolytics
Type of Form Form-5
Me-too status Erdozet Capsules 150mg by M/s S.J&G
(Reg#073809)
renewal of DML.
Decision:
Dated 14-02-2018
Valsartan…160mg
blockers
Type of Form Form-5
Approval status of product in Reference Amlodipine/Valsartan 5 mg/160 mg film-coated
Regulatory Authorities. tablets by M/s Genus Pharmaceuticals Ltd (MHRA
Approved)
renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Guflinz 400mg Tablets
Dated 14-02-2018
Linezolid…400mg
Type of Form Form-5
Pack size & Demanded Price 12’s/As per SRO.
Regulatory Authorities. Limited, (USFDA approved.)
renewal of DML.
Decision:
Dated 14-02-2018
Erdosteine…175mg
Type of Form Form-5
Me-too status Not confirmed.
renewal of DML.
database.
Decision:
Dated 14-02-2018
Erdosteine…300mg
Type of Form Form-5
Approval status of product in Reference Erdotin 300 mg Capsules by M/s Edmond Pharma Srl
Regulatory Authorities. (MHRA Approved)
Me-too status Erdozet Capsules 300mg by M/s S.J&G
(Reg#070859)
renewal of DML.
Decision:
283. Name and address of manufacturer / M/s Shaigan Pharmaceuticals (Pvt) Ltd, 14 KM
Applicant Adyala Raod Post Office Daghal, Rawalpindi
Brand Name +Dosage Form + Strength Etam Injection
Dated 14-02-2018
Etamsylate…250mg
Pharmacological Group Vitamin K and other hemostatics (Other systemic
hemostatics)
Type of Form Form-5
Pack size & Demanded Price 6’s Ampoule / As per SRO
Approval status of product in Reference DICYNONE 250 mg/2 ml, solution injectable
Regulatory Authorities. (ampoule) by M/s Vifor France (ANSM Approved)
Me-too status Dicynone Injection 250mg/2ml (ampoule) by M/s
Routine GMP Inspection
Company is found complying GMP
Decision:
Brand Name +Dosage Form + Strength Isolide Gel
Dated 14-02-2018
Composition Each gram of gel contains:
Isotretinoin …0.5mg (0.05%w/w)
Erythromycin …20mg (2%w/w)
Pharmacological Group Anti-acne preparations for topical use
Type of Form Form-5
Pack size & Demanded Price 10g /As per SRO
Approval status of product in Reference Isotrexin Gel by M/s GlaxoSmithKline UK Limited
Me-too status Isotrexin Gel by M/s Stiefel Laboratories
(Reg#047552)
Decision:
Brand Name +Dosage Form + Strength Oronide 60mg Tablets
Dated 14-02-2018
Composition Each film caoted tablet contains:
Nateglinide…60mg
Pharmacological Group Other blood glucose lowering drugs, excl. insulins
Type of Form Form-5
Approval status of product in Reference Starlix film-coated 60mg Tablets by M/s Novartis
Regulatory Authorities. Europharm Limited (HPRA Ireland Approved)
Me-too status Starlix Film Coated Tablets 60mg by M/s Novartis
(Reg#027341)
Decision:
Brand Name +Dosage Form + Strength Oronide 120mg Tablets
Dated 14-02-2018
Composition Each film caoted tablet contains:
Nateglinide…60mg
Pharmacological Group Other blood glucose lowering drugs, excl. insulins
Type of Form Form-5
Approval status of product in Reference Starlix film-coated 120mg Tablets by M/s Novartis
Regulatory Authorities. Europharm Limited (HPRA Ireland Approved)
Me-too status Starlix Film Coated Tablets 60mg by M/s Novartis
(Reg#027340)
Decision:
Brand Name +Dosage Form + Strength Ulgin Liquid
Dated 14-02-2018
Sodium Alginate…500mg
Calcium Carbonate…160mg
Pharmacological Group Antacid
Type of Form Form-5
Finished Product Specification BP
Pack size & Demanded Price 120ml/ As per SRO
Approval status of product in Reference Gaviscon oral liquid peppermint bottle by M/s Reckitt
Regulatory Authorities. Benckiser Pty Ltd, (TGA approved)
Me-too status Ul-Nil Suspension by M/s Z-Jans. (Reg# 052470)
Remarks of the Evaluator.  Evidence of Atomic absorption apparatus not
submitted by the firm.
Decision:
Brand Name +Dosage Form + Strength Acetosol Infusion 1g/100ml
Dated 14-02-2018
Paracetamol…1g
Pharmacological Group Other analgesics and antipyretics (Anilides)
Type of Form Form-5
Approval status of product in Reference Paracetamol 1000 mg/100ml Solution for Infusion
Regulatory Authorities. (Vial) by M/s Sandoz Limited (MHRA Approved)
Me-too status Bofalgan 1g/100ml Infusion (Vial) M/s Bosch
Pharmaceuticals (Reg#070607)
Decision:
Brand Name +Dosage Form + Strength Vomipreg Tablets 10/10mg
Dated 14-02-2018
Composition Each Enteric coated tablet contains:
Doxylamine Succinate …10mg
Pyridoxine hydrochloride …10mg
Pharmacological Group Anti-Histamine + Vitamin B6
Type of Form Form-5
Approval status of product in Reference Doxylamine Succinate And Pyridoxine Hydrochloride
Regulatory Authorities. Tablet, Delayed Release by M/s Actavis Labs Fl Inc.
(USFDA Approved)
Me-too status Nausidox 10mg/10mg Tablet OBS Pakistan.
(Reg#076292)
Decision:
Brand Name +Dosage Form + Strength Sterile Water for injection 4ml
Dated 12-02-2018
Sterile Water for injection…4ml
Pharmacological Group Diluent
Type of Form Form-5
Pack size & Demanded Price 1’s / As per SRO
Approval status of product in Reference -
Me-too status Water for Injection 4ml ampoule by M/s Healthtek
(Reg#079940)
GMP status 11-10-2017 & 16-10-2017
Firm is operating at satisfactory level of GMP
compliance.
Remarks of the Evaluator.  Approval of manufacturing facility for production
of said formulation could not be confirmed.
Decision:
Brand Name +Dosage Form + Strength Sterile Water for injection 2ml
Dated 12-02-2018
Sterile Water for injection…2ml
Type of Form Form-5
Approval status of product in Reference -
Me-too status Water for Injection 2ml ampoule by M/s Healthtek
(Reg#076466)
GMP status 11-10-2017 & 16-10-2017
compliance.
of said formulation could not be confirmed
Decision:
Brand Name +Dosage Form + Strength Met-Cort Cream 2%w/w + 1% w/w
Dated 12-02-2018
Composition Each gram Cream contains
Miconazole nitrate …20mg (2%w/w)
Hydrocortisone …10mg (1%w/w)
Pharmacological Group Antifungals for topical use (Imidazole and triazole
derivative + Corticosteroid)
Type of Form Form-5
Approval status of product in Reference Daktacort 2% / 1% w/w cream by M/s Janssen-Cilag
Me-too status Micasone Cream by M/s Leonine Pharma
(Reg#013602)
GMP status 11-10-2017 & 16-10-2017
compliance.
Decision:
293. Name and address of manufacturer / M/s Pharma Lord (Pvt) Ltd, 12 KM, Lahore Raod,
Applicant Layyah, Punjab
Brand Name +Dosage Form + Strength QGEM 320mg Tablet
Dated 15-02-2018
Gemifloxacin (as mesylate) …320mg
Pharmacological Group Fluoroquinolone
Type of Form Form-5
Pack size & Demanded Price 7’s, 10x10’s/ As per SRO
Approval status of product in Reference Factive film-coated tablet 320mg by M/s Merus Labs
Regulatory Authorities. International, Inc (USFDA Approved)
Me-too status Genflox 320mg Tablet by M/s High-Q
GMP status Last GMP inspection is conducted on 26-05-17 &
report concludes that firm was considered GMP
compliant
Decision:
Brand Name +Dosage Form + Strength Qmox 400mg Tablet
Dated 15-02-2018
Moxifloxacin (as hydrochloride) …400mg
Type of Form Form-5
Approval status of product in Reference Avelox 400 mg film-coated tablets by M/s Bayer plc
Me-too status Moxiflox Tablets 400mg by M/s Mediceena Pharma
(Reg#034453)
compliant
Decision:
Brand Name +Dosage Form + Strength Lezin 5mg Tablet
Dated 15-02-2018
Levocetirizine dihydrochloride …5mg
Pharmacological Group Antihistamines for systemic use (Piperazine
derivatives)
Type of Form Form-5
Approval status of product in Reference Levocetirizine dihydrochloride 5mg film-coated
Regulatory Authorities. tablets by M/s Manx Healthcare Ltd (MHRA
Approved)
Me-too status Levrix Tablets 5mg by M/s AGP (Reg#034675)
compliant
Decision:
Brand Name +Dosage Form + Strength Otron 8mg Tablet
Dated 15-02-2018
Ondansetron (as hydrochloride dihydrate). …8mg
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form-5
Approval status of product in Reference Ondansetron 8 mg film-coated tablets by M/s Teva
Regulatory Authorities. UK Limited (MHRA Approved)
Me-too status Welon Tablets 8mg by M/s Werrick (Reg#029561)
compliant
Decision:
Brand Name +Dosage Form + Strength Deslor 5mg Tablet
Dated 15-02-2018
Desloratadine …5mg
Pharmacological Group Other antihistamines for systemic use
Type of Form Form-5
Approval status of product in Reference Desloratadine 5 mg film-coated tablets by M/s Bristol
Regulatory Authorities. Laboratories Ltd (MHRA Approved)
Me-too status Aerius Film Coated Tablets 5mg by M/s ICI Pakistan
LTD (Reg#031370)
compliant
Decision:
Brand Name +Dosage Form + Strength Captop 25mg Tablet
Dated 15-02-2018
Captopril …25mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 2x10’s, 10x10’s/ As per SRO
Approval status of product in Reference Captopril 25mg Tablets by M/s Tillomed Laboratories
Regulatory Authorities. Ltd (MHRA Approved)
Me-too status Capoten 25mg tablet by M/s Squibb Khi
(Reg#006156)
compliant
Decision:
Brand Name +Dosage Form + Strength Captop 50mg Tablet
Dated 15-02-201
Captopril …50mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 2x10’s, 10x10’s/ As per SRO
Approval status of product in Reference Captopril 50mg Tablets by M/s Tillomed Laboratories
Regulatory Authorities. Ltd (MHRA Approved)
Me-too status Capoten 50mg tablet by M/s Squibb Khi
(Reg#006157)
compliant
Decision:
Brand Name +Dosage Form + Strength Oxalid 600mg Tablet
Dated 15-02-2018
Linezolid…600mg
Type of Form Form-5
Pack size & Demanded Price 2x6’s, 10x10’s/ As per SRO
Regulatory Authorities. Limited, (MHRA approved.)
compliant
Decision:
Brand Name +Dosage Form + Strength Clar 250mg Tablet
Dated 15-02-2018
Clarithromycin …250mg
Pharmacological Group Macrolides
Type of Form Form-5
Approval status of product in Reference Clarithromycin 250 mg Film-coated Tablets by M/s
Regulatory Authorities. Teva UK Limited (MHRA Approved)
Me-too status Clara 250mg Tablet by M/s Saydon Pharma
(Reg#023322)
compliant
Decision:
Brand Name +Dosage Form + Strength Clar 500mg Tablet
Dated 15-02-2018
Type of Form Form-5
Approval status of product in Reference Clarithromycin 500 mg Film-coated Tablets by M/s
Me-too status Clara 500mg Tablet by M/s Saydon Pharma
(Reg#023323)
compliant
Decision:
303. Name and address of manufacturer / M/s Novamed Pharmaceuticals (Pvt) Ltd.
Applicant 28-km,Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Galvecta Plus Tablet 50/500mg
Dated 15-02-2018
Vildagliptin…50mg
Type of Form Form-5
Approval status of product in Reference GALVUMET 50/500 film coated tablet by M/s
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Ltd
(TGA Approved)
Me-too status Galvus Met 50/500mg Tablets by M/s Novartis
(Reg#078106)
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.
Decision:
304. Name and address of manufacturer / M/s Novamed Pharmaceuticals (Pvt) Ltd.
Applicant 28-km,Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Demant Tablet 10mg
Dated 15-02-2018
Memantine hydrochloride …10mg
Pharmacological Group Other anti-dementia drugs
Type of Form Form-5
Approval status of product in Reference Memantine 10 mg film-coated tablets by M/s Aristo
Regulatory Authorities. Pharma GmbH (MHRA Approved)
Me-too status Zexa Tablets 10mg by M/s Mass Pharma (Pvt) Ltd
(Reg#040700)
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.
Decision:
305. Name and address of manufacturer / M/s Bio Labs Pvt Ltd.
Applicant Plot # 145, Industrial Triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength Tacrol 0.1%w/w Ointment
Dated 15-02-2018
Composition Each gram contains:
Tacrolimus (as monohydrate)…1mg (0.1%w/w)
Pharmacological Group Agents for dermatitis, excluding corticosteroids
Type of Form Form-5
Pack size & Demanded Price 10g, 30g /As per SRO
Approval status of product in Reference Tacrolimus Accord 0.1 % ointment by M/s Accord
Regulatory Authorities. Healthcare Limited (MHRA Approved)
Me-too status Limus 0.1% Ointment by M/s Nabiqasim
(Reg#045215)
inspection conducted on 5th & 6th December 2017.
Decision:
306. Name and address of manufacturer / M/s Bio Labs Pvt Ltd.
Applicant Plot # 145, Industrial Triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength Osteo-Cure 50mg Capsule
Dated 15-02-2018
Diacerein…50mg
Pharmacological Group Other antiinflammatory and antirheumatic agents,
non-steroids
Type of Form Form-5
Approval status of product in Reference DIACEREIN BIOGARAN 50 mg hard capsule by
Regulatory Authorities. M/s
BIOGARAN (ANSM, France Approved)
Me-too status Dibro 50mg capsules by M/s Winbrain Research
Laboratories (Reg#071639)
inspection conducted on 5th & 6th December 2017.
Remarks of the Evaluator. Brand name resemblance.
Decision:
307. Name and address of manufacturer / M/s Medizan Laboratories (Pvt) Ltd, Plot No. 313,
Applicant Industrial Triangle, Kahuta road, Islamabad
Brand Name +Dosage Form + Strength Pletanant-100mg Tablet
Dated 15-02-2018
Cilostazol …100mg
Pharmacological Group Platelet aggregation inhibitors excl. heparin
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s/ As per SRO
Approval status of product in Reference Cilostazol 100 mg tablets by M/s Generics [UK] Ltd
Regulatory Authorities. t/a Mylan (MHRA Approved)
Me-too status Prigtal Tablets 100mg by M/s Getz (Reg#036229)
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.
Decision:
Brand Name +Dosage Form + Strength Lamital 300mg Tablet
Dated 15-02-2018
Lamotrigine…300mg
Pharmacological Group Other antiepileptics
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s, 60’s, 150’s/ As per SRO
Approval status of product in Reference LAMICTAL XR extended-release tablets 300mg by
Regulatory Authorities. M/s GlaxoSmithKline (USFDA Approved)
Remarks of the Evaluator.  Me-too status not confirmed from available
database.
 Firm has applied as film coated tablet whereas
formulation approved in USFDA is extended-
release tablet.
Decision:
Brand Name +Dosage Form + Strength Aspide 200mg Tablets
Dated 15-02-2018
Amisulpride…200mg
Pharmacological Group Antipsychotics (Benzamides)
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s, 60’s, / As per SRO
Approval status of product in Reference Amisulpride 200mg Tablets by M/s Accord-UK Ltd
Me-too status Amiride Tablet 200mg by M/s Shrooq
Pharmaceuticals (Pvt) Ltd (Reg#063102)
Decision:
Dated 15-02-2018
Lamotrigine…50mg
Type of Form Form-5
Approval status of product in Reference Lamotrigine Actavis 50mg tablets by M/s Actavis UK
Me-too status Lamictal Tablets 50mg by M/s GSK (Reg#014919)
Decision:
Dated 15-02-2018
Lamotrigine…100mg
Type of Form Form-5
Approval status of product in Reference Lamotrigine Actavis 100mg tablets by M/s Actavis
Me-too status Lamictal Tablets 100mg by M/s GSK (Reg#014921)
Decision:
Dated 15-02-2018
Amisulpride…100mg
Type of Form Form-5
Me-too status Solium-100 Tablets by M/s Genome Pharmaceuticals
(Pvt,) Ltd (Reg#074533)
Decision:
Dated 15-02-2018
Amisulpride…50mg
Type of Form Form-5
Me-too status Solium-50 Tablets by M/s Genome Pharmaceuticals
(Pvt,) Ltd (Reg#064017)
Decision:
Brand Name +Dosage Form + Strength Pletanant-50mg Tablet
Dated 15-02-2018
Cilostazol …50mg
Pharmacological Group Platelet aggregation inhibitors excl. heparin
Type of Form Form-5
Pack size & Demanded Price 10’s, 60’s, / As per SRO
Approval status of product in Reference Cilostazol 50 mg tablets by M/s Generics [UK] Ltd t/a
Regulatory Authorities. Mylan (MHRA Approved)
Me-too status Prigtal Tablets 50mg by M/s Getz (Reg#036228)
Decision:
Brand Name +Dosage Form + Strength Phloronal-80mg Tablets
Dated 15-02-2018
Phloroglucinol dihydrate…80mg
Trimethylphloroglucinol…80mg
Pharmacological Group Other drugs for functional gastrointestinal disorders
Type of Form Form-5
Approval status of product in Reference SPASFON, coated tablet by M/s Teva Health (ANSM
Regulatory Authorities. approved.)
Me-too status Anafortan Plus Tablet by M/s AGP Pharma
(Reg#024504)
Decision:
Karachi
Brand Name +Dosage Form + Strength Prazo Tablet 1mg
Dated 14-02-2018
Composition Each Tablet contains:
Alprazolam …1mg
Type of Form Form 5
Approval status of product in Reference Alprazolam Mylan 1 mg, tablet by M/s Mylan Sas
Regulatory Authorities. (ANSM France Approved)
Me-too status Alprazolam 1 mg Tablets by M/s Heal
Pharmaceuticals (Reg.# 079392)
Firm is operating at good level of GMP compliance.
of said formulation could not be confirmed
Decision:
317. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt) Ltd.
Applicant 62 Quaid e Azam Industrial Estate,Kot,
Lakhpat,Lahore
Brand Name +Dosage Form + Strength Colitis ER Tablet 400mg
Diary No. Date of R& I & fee Duplicate dossier : duplicate fee challan of Rs.
20,000/-
(06-07-2017) (Challan#0593963)
Dy.No 38004 dated 19-11-2018
Composition Each enteric coated Tablet contains:
Mesalamine…400mg
Pharmacological Group Intestinal antiinflammatory agents (Aminosalicylic
acid and similar agents)
Type of Form Form 5
Pack size & Demanded Price 10’s, 3x10’s / As per SRO
Approval status of product in Reference ASACOL mesalazine 400 mg enteric coated by M/s
Regulatory Authorities. Emerge Health Pty Ltd (TGA Approved)
Me-too status Mesacam 400mg EC Tablets by M/s Genome (Reg.#
084212)
conducted on 20-04-2018 & 24-04-2018, concluding
satisfactory level of GMP compliance.
Decision:
318. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt) Ltd.
Applicant 62 Quaid e Azam Industrial Estate,Kot,
Lakhpat,Lahore
Brand Name +Dosage Form + Strength Colitis ER Tablet 800mg
Diary No. Date of R& I & fee Duplicate dossier : duplicate fee challan of Rs.
20,000/-
(06-07-2017) (Challan#0593963)
Dy.No 38005 dated 19-11-2018
Composition Each enteric coated Tablet contains:
Mesalamine…800mg
Pharmacological Group Intestinal antiinflammatory agents (Aminosalicylic
acid and similar agents)
Type of Form Form 5
Pack size & Demanded Price 10’s, 3x10’s / As per SRO
Approval status of product in Reference ASACOL mesalazine 800 mg enteric coated by M/s
Regulatory Authorities. Emerge Health Pty Ltd (TGA Approved)
Me-too status Mesal 800mg EC Tablets by M/s Highnoon (Reg.#
081380)
Decision:
Evaluator PEC-XIII
319. Name and address of manufacturer / M/s Akhai Pharmaceuticals Pvt. Limited, Plot
Applicant No. A- 248 & A- 256 to 259 H.I.T.E. Lasbella,
Balochistan.
Brand Name +Dosage Form + Strength Desco tablet 5mg
Desloratadine ……………..5mg
Pharmacological Group Antihistamine/ Anti-allergic
Type of Form Form -5
Finished product Specification Manufacturers
Pack size & Demanded Price 1x 10’s & As per SRO
Approval status of product in Reference Desloratadine film-coated tablet 5mg of M/s Lupin
Regulatory Authorities Healthcare (UK) Limited (MHRA Approved)
Me-too status Destina tablet 5mg of M/s Hilton Pharma
(Reg. # 039364 )
GMP status Last GMP inspection was conducted on 03-08-
2017 and the report concludes good GMP
compliance.
Remarks of the Evaluator XIII  Firm has General Tablet section as
mentioned in the submitted GMP
inspection report.
 No official monograph is available in USP,
BP, IP or JP.
Decision:
320. Name and address of manufacturer / M/s Genix Pharma Pvt. Limited, 44, 45-B,
Applicant Korangi Creek Road, Karachi.
Brand Name +Dosage Form + Strength Water for injection 2ml
Water for injection …...2ml
Pharmacological Group Diluent / Solvent for reconstitution
Type of Form Form-5
Pack size & Demanded Price 2ml ampoule x 5’s ; 2ml ampoule x 10’s & as per
PRC
Approval status of product in Reference Sterile water for injection of M/s Pfizer Limited
Regulatory Authorities (MHRA Approved)
Me-too status Water for injection of M/s Epoch Pharmaceuticals
(Reg. # 047128)
2018 and the report concludes an acceptable level
of GMP compliance.
Remarks of the Evaluator  Firm has liquid injectable (vial, ampoule
and infusion) section as mentioned in the
section approval letter.
Decision:
Brand Name +Dosage Form + Strength Water for injection 4ml
Water for injection …..4ml
Pharmacological Group Diluent / Solvent for reconstitution
Type of Form Form-5
Pack size & Demanded Price 4ml ampoule x 5’s ; 4ml ampoule x 10’s & as per
PRC
Approval status of product in Reference Sterile water for injection of M/s Pfizer Limited
Me-too status Sterile water for injection 4ml of M/s Healthtek,
Karachi (Reg. # 079940)
of GMP compliance.
Remarks of the Evaluator  Firm has liquid injectable (vial, ampoule
and infusion) section as mentioned in the
Decision:
Brand Name +Dosage Form + Strength Levarol inhalation solution 0.63mg
Levalbuterol as HCl………0.63mg
Pharmacological Group Beta-2 Agonist
Type of Form Form- 5
Finished product Specification U.S.P.
Pack size & Demanded Price 3ml, 5ml, 10ml & as per PRC
Approval status of product in Reference Xopenex inhalation solution 0.63mg, 0.021% (3ml)
Regulatory Authorities of M/s Oak Pharms Inc. (USFDA Approved)
of GMP compliance.
Remarks of the Evaluator  Firm has Inhaler section as mentioned in
the section approval letter.
 Firm has applied three volumes i.e. 3ml,
5ml and 10ml while only 3ml is approved
in USFDA.
 Stability is required for the applied
formulation so firm needs to resubmit the
application on Form-5D with submission of
additional fees and stability studies data as
per decision of 276th meeting.
Decision:
Brand Name +Dosage Form + Strength Levarol inhalation solution 1.25mg
Levalbuterol as HCl………1.25mg
Pharmacological Group Beta-2 Agonist
Pack size & Demanded Price 3ml, 5ml, 10ml & as per SRO
Approval status of product in Reference Xopenex inhalation solution 1.25mg, 0.042% (3ml)
Regulatory Authorities of M/s Oak Pharms Inc. (USFDA Approved)
of GMP compliance.
Remarks of the Evaluator  Firm has Inhaler section as mentioned in
the section approval letter.
 Firm has applied three volumes i.e. 3ml,
5ml and 10ml while only 3ml is approved
in USFDA.
 Stability is required for the applied
formulation so firm needs to resubmit the
application on Form-5D with submission of
additional fees and stability studies data as
per decision of 276th meeting.
Decision:
324. Name and address of manufacturer / M/s Unexolabs (Pvt.) Limited, 9.5 km
Applicant Sheikhupura Road, Lahore.
Brand Name +Dosage Form + Strength Cefdrox capsule 500mg
Cefadroxil (as Monohydrate)……….500mg
Diary No. Date of R& I & fee Dy.No.454; 04-01-2018;Rs.20,000/- (04-01-2018)
Pharmacological Group First Generation Cephalosporin
Finished product Specification Not claimed
Pack size & Demanded Price 3x 4’s & not claimed
Approval status of product in Reference Cefadroxil 500mg capsules of M/s Sandoz Limited,
Regulatory Authorities UK (MHRA Approved)
Me-too status Duricef 500mg capsule of M/s Bristol Myer,
2016 and the report concludes:
“Firm has shown positive approach towards
compliance of GMP and advices were given for
further up-gradation.”
Remarks of the Evaluator XIII  Firm has General Capsule section as
mentioned in the GMP inspection report.
 The official monograph of the applied
formulation is available in USP.
 Submitted GMP report does not show
compliant status.
Decision:
Brand Name +Dosage Form + Strength Pregalin capsule 50mg
Pregabalin ……………………50mg
Pharmacological Group Anti- epileptic
Pack size & Demanded Price 14’s & not claimed
Approval status of product in Reference Axalid 50mg hard capsule of M/s Kent
Regulatory Authorities Pharmaceuticals, Limited (MHRA Approved)
Me-too status Gabica 50 mg capsule of M/s Getz Pharma,
 No official monograph of the applied
formulation is available in USP, BP, IP or
JP.
compliant status.
Decision:
Brand Name +Dosage Form + Strength Pregalin-75 capsule
Pack size & Demanded Price 14’s & not claimed
JP.
compliant status.
Decision:
JP.
compliant status.
Decision:
JP.
compliant status.
Decision:
Brand Name +Dosage Form + Strength Torvastin-20 tablet (20mg)
Atorvastatin as Calcium Trihydrate ………..20mg
Pharmacological Group HMG CoA Reductase Inhibitor
Me-too status Atorlip 20mg tablet of M/s Pearl Pharma
(Reg. # 034931 )
Remarks of the Evaluator XIII  Firm has General tablet section as
JP.
compliant status.
Decision:
330. Name and address of manufacturer / M/s Zaynoon Pharmaceuticals Pvt Limited.
Applicant 27/28-B, Industrial Estate, Hayatabad, Peshawar,
Pakistan
Brand Name +Dosage Form + Strength Nafpol Drops 100mg/ml
Paracetamol…….100mg
Diary No. Date of R& I & fee Dy. No 860; 05-01-2018; Rs.20,000/- (05-01-2018)
Pharmacological Group Analgesic / Antipyretic
Type of Form Form-5
Pack size & Demanded Price 60ml & Rs. 20/-
Me-too status Chilpol drops 100mg/ ml of M/s Alliance Pharma
(Reg. # 068435)
2017 and the report concludes satisfactory GMP
compliance.
Remarks of the Evaluator XIII  No official monograph for the applied
JP.
 The international availability for the
applied formulation could not be
confirmed.
 Drops are applied in amber glass bottle.
 Firm has only one approved section i.e.
“Oral liquid” as mentioned in the submitted
GMP report.
Decision:
331. Name and address of manufacturer / M/s Zaynoon Pharmaceuticals Pvt. Limited,
Pakistan
Brand Name +Dosage Form + Strength Nafpol total suspension 120mg + 1mg/ 5ml
Paracetamol (Micronised)…………..120mg
Chlorpheniramine Maleate……………1mg
Pharmacological Group Analgesic / Anti-pyretic/Anti-histamine
Type of Form Form-5
Me-too status Pedrol Total suspension of M/s Stanley Pharma
(Reg. # 026268)
compliance.
Remarks of the Evaluator XIII  Firm has only one approved section i.e.
“Oral liquid” as mentioned in the submitted
GMP report.
 Applied in amber glass bottle.
confirmed.
Decision:
Pakistan
Brand Name +Dosage Form + Strength Zaycon drops (Oral suspension) 40mg/ ml (30ml)
Simethicone ………………………….……40mg
Pharmacological Group Anti- flatulent
Type of Form Form-5
Me-too status Minicol 40mg/ml Oral Drops by M/s Libra
(Reg. # 036627)
compliance.
Remarks of the Evaluator XIII  Applied in amber glass bottle.
 The official monograph for the applied
 Firm has oral liquid section as mentioned
in the GMP inspection report.
confirmed.
Decision:
Pakistan
Brand Name +Dosage Form + Strength P- Barbit Elixir 20mg/ 5ml
Phenobarbital ……...20mg
Pharmacological Group Anti- convulsant/ Anti-epileptic
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml & Rs. 24/- for 60ml ; Rs. 40/- for
120ml
Approval status of product in Reference Could not be confirmed in the applied strength
Regulatory Authorities (Available strengths are 15mg/ ml in MHRA and
TGA, Australia)
Me-too status Debritone 20mg/ 5ml Elixir of M/s Xenon Pharma
compliance.
Remarks of the Evaluator XIII  The official monograph for the applied
formulation is not available in USP, BP, IP
or JP.
 International reference could not be
confirmed in the applied strength.
Decision:
334. Name and address of manufacturer / M/s Lisko Pakistan (Pvt.) Limited, L-10-D Block-
Applicant 21 Shaheed Rashid Minhas Road, F.B. Industrial
Area, Karachi
Brand Name +Dosage Form + Strength Nitox tablet 500mg
Composition Each film- coated tablet contains:
Nitazoxanide…………….500mg
Diary No. Date of R& I & fee Dy.No.326;03-01-2018; Rs.20,000/- (20-11-2017)
Pharmacological Group Broad spectrum Anti-parasitic Thiazolide
Pack size & Demanded Price 10’s, 20’s, 30’s & Rs. 50/-per tablet
Approval status of product in Reference Alinia 500mg film- coated tablet of M/s Romark
Regulatory Authorities Pharmaceuticals (USFDA Approved)
Me-too status Nitazide 500mg tablet of M/s Helix Pharma
(Reg. # 075908)
2018 and the report concludes satisfactory level of
GMP compliance.
mentioned in the submitted GMP report.
 No official monograph is available in USP,
BP, IP or JP for the applied formulation.
Decision:
Area, Karachi
Brand Name +Dosage Form + Strength Levit tablet 250mg
Levetiracetam …………..250mg
Pharmacological Group Pyrrolidone derivative (Anti-epileptic)
Pack size & Demanded Price 10’s, 30’s & Rs. 100/- per tablet
Approval status of product in Reference Keppra 250mg film-coated tablet of M/s UCB
Regulatory Authorities Pharma Limited (MHRA Approved)
Me-too status Keppra tablet 250mg of M/s AGP Pharma
(Reg. # 045684)
GMP compliance.
Decision:
Area, Karachi
Pack size & Demanded Price 10’s, 30’s & Rs. 100/- per tablet
Me-too status Keppra tablet 500mg of M/s AGP Pharma
(Reg. # 045685)
GMP compliance.
Decision:
Area, Karachi
Pack size & Demanded Price 10’s & Rs. 100/- per tablet
Me-too status Lumark 750mg tablet of M/s Searle Pharma
(Reg. # 069065)
GMP compliance.
Decision:
Area, Karachi
Brand Name +Dosage Form + Strength Levit oral solution 100mg/ ml
Levetiracetam ……….….…..100mg
Pack size & Demanded Price 30ml, 60ml, 90ml, 120ml & Rs. 200/-, Rs. 400/-
Rs.550/-, Rs. 850/-per bottle respectively
Me-too status Tamlev 100mg/ ml oral solution of M/s Medisure
(Reg. # 081613)
GMP compliance.
Remarks of the Evaluator XIII  Firm has Liquid Syrup section as
Decision:
339. Name and address of manufacturer / M/s Theramed Pharmaceutical (Pvt.) Limited, 45
Applicant km, Multan road, Lahore.
Brand Name +Dosage Form + Strength Rismed tablet 1mg
Risperidone …………….....1mg
Diary No. Date of R& I & fee Dy.No.25934;26-12-2017;Rs.20,000/-(21-12-2017)
Pack size & Demanded Price 10’s, 18’s, 20’s, 30’s, 50’s & As per DRAP policy
Me-too status Benzisox of M/s Highnoon Laboratories
2017 and the report concludes renewal of DML and
grant of additional sections.
Remarks of the Evaluator XIII  Firm has General Tablet section as is
Decision:
Brand Name +Dosage Form + Strength C- Pine tablet 25mg
Clozapine……………..…..25mg
Pack size & Demanded Price 14’s, 30’s, 50’s & as per DRAP policy
Approval status of product in Reference Approved as uncoated in USFDA and MHRA
Me-too status Clozaril tablet 25mg of M/s Novartis Pharma
Remarks of the Evaluator XIII  Firm has applied the formulation as film-
coated tablet while it is approved as
uncoated in USFDA and MHRA.
 Firm has General Tablet section as is
Decision:
Brand Name +Dosage Form + Strength ET- Oxine capsule 50mg
Etifoxine HCl...….50mg
Pharmacological Group Anxiolytic
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 12’s, 24’s & As per DRAP policy
Approval status of product in Reference ANSM (France) Approved
Me-too status Stresam capsule 50mg of M/s CCL Pharma
(Reg. # 024595)
Remarks of the Evaluator XIII  The official monograph for the applied
formulation is not available in USP or BP.
Decision:
Brand Name +Dosage Form + Strength V- Fexin 37.5mg capsule
SR pellets of Venlafaxine HCl eq. to Venlafaxine
…………………………………………....37.5mg
Pharmacological Group Anti- depressant
Pack size & Demanded Price 10’s, 14’s, 20’s & As per DRAP policy
Me-too status Faxine SR 37.5mg capsule of M/s Semos (Reg. #
055879)
Remarks of the Evaluator XIII  Source of pellets is M/s Vision Pharma.
 Firm has submitted data of pellets
including stability data, CoA of
manufacturer.
 GMP certificate of the manufacturer
remains valid till 21-02-2018.
Decision:
Brand Name +Dosage Form + Strength V- Fexin 75mg capsule
SR pellets of Venlafaxine HCl eq. to Venlafaxine
…………………………………………......75mg
Pharmacological Group Anti- depressant
Pack size & Demanded Price 10’s, 14’s, 20’s & As per DRAP policy
Me-too status Faxine 75mg capsule of M/s Semos(Reg.# 055878)
Remarks of the Evaluator XIII  Source of pellets is M/s Vision Pharma.
 Firm has submitted data of pellets
including stability data, CoA of
manufacturer.
 GMP certificate of the manufacturer
remains valid till 21-02-2018.
Decision:
344. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot No. 31, 32,
Applicant Punjab Small Industrial Estate, Taxilla.
Brand Name +Dosage Form + Strength Low-lip 10mg tablet
Diary No. Date of R& I & fee Dy.No.26688; 29-12-2017;Rs.20,000/-(29-12-
2017)
Pharmacological Group Selective competitive inhibitor of HMG-CoA
reductase Inhibitor (Statins)
Finished product Specification Innovator’s
Pack size & Demanded Price As per SRO & as per SRO
Me-too status Rovista 10mg tablet of M/s Getz Pharma (Reg.#
044044)
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.
Decision:
Applicant Punjab Small Industioral Estate, Taxilla.
Brand Name +Dosage Form + Strength Low- lip 20mg tablet
Diary No. Date of R& I & fee Dy.No.26689; 29-12-2017;Rs.20,000/-(28-12-
2017)
Pharmacological Group Selective competitive inhibitor of HMG-CoA
reductase Inhibitor (Statins)
Me-too status Rovista 20mg tablet of M/s Getz Pharma (Reg.#
044045)
GMP certificate.
Decision:
346. Name and address of manufacturer / M/s Star Laboratories (Pvt.) Ltd. 23 kilometer,
Applicant Multan road, Lahore
Brand Name +Dosage Form + Strength Montel Paediatric Sachet 4mg
Composition Each sachet contains:
Montelukast as Sodium…4 mg
Diary No. Date of R& I & fee Dy. No. 463;27-01-2014; Rs.20,000/- (27-01-2014)
Pharmacological Group Leukotriene Receptor Antagonist
Type of Form Form-5
Finished product Specification Innovators
Me-too status Montiwel 4mg Sachet of M/s Welwrd
Pharmaceuticals (Reg. # 075518)
2016 and GMP certificate is provided for export
purpose.
Remarks of the Evaluator XIII  Firm has Oral Dry Powder Sachet section
as mentioned in the section approval letter.
Decision:
347. Name and address of manufacturer / M/s Ameer & Adnan Pharmaceuticals (Pvt.)
Applicant Limited, Plot # 47, Sunder Industrial Estate,
Lahore
Brand Name +Dosage Form + Strength Adcipro Infusion 500mg
Composition Each 100ml injectable solution contains:
Ciprofloxacin as Lactate………..200mg
Diary No. Date of R& I & fee Dy. No. 285;06-02-2017; Rs.20,000/- (06-02-2017)
Pharmacological Group Quinolone Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1’s & as per SRO
Me-too status Cipgreen Infusion 200mg/ 100ml of M/s Evergreen
Pharmaceuticals (Reg. # 062617)
2018 and the report concludes the firm to be GMP
compliant.
Remarks of the Evaluator XIII  Firm has Liquid Injectable General /
Infusion section as mentioned in the
Decision:
348. Name and address of manufacturer / M/s Inventor Pharma, Plot # K/196, S.I.T.E.,
Applicant (SHW) Phase –II, Karachi.
Brand Name +Dosage Form + Strength Lactol syrup 3.35gm/ 5ml
Lactitol Monohydrate……….3.35gm
Diary No. Date of R& I & fee Dy. No. 25410; 21-12-2017; Rs.1,00,000/- (21-12-
2017)
Pharmacological Group To treat constipation and chronic encephalopathy
Pack size & Demanded Price 120ml & As per DRAP policy
Approval status of product in Reference Lactitol Monohydrate by M/s Zambon Schweiz AG
Regulatory Authorities (Swiss Medica) Switzerland Approved
Me-too status Lacasil syrup 3.35gm/ 5ml of Sami Pharmaceuticals
(Reg. # 070552)
and the report concludes good level of GMP
compliance.
Remarks of the Evaluator  Evidence of availability of RI detector needs
to be confirmed by the firm.
 Source of lactitol, along with stability
studies data, GMP certificate of supplier
needs to be submitted.
 Firm has oral Liquid General section.
 Letter was issued to the firm on 3rd Dec.,
2018 but still no reply has been received.
Decision:
349. Name and address of manufacturer / M/s Saibins Pharmaceuticals, Plot # 316,
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Lonofast tablet 4mg
Lornoxicam…………….....4mg
Pharmacological Group NSAIDs
Pack size & Demanded Price 1x 10’s & as per SRO
Approval status of product in Reference Xefo 4 mg Filmtabletten by M/s Takeda Pharma
Regulatory Authorities AG, (Swiss Medic approved)
Me-too status Nicam Tablets of M/s S.J & G Fazul Ellahie (Pvt.)
Ltd, (Reg. # 061603)
2018 & 28-12-2018 and the report concludes
renewal of DML.
Remarks of the Evaluator XIII  No USP or BP monograph is available for
the applied formulation.
 Letter was issued to the firm on 29th Jan.,
2019 but the firm has not replied yet.
 The formulation is applied as film-coated
while film-coating is not mentioned in the
master formulation.
 3% overage is applied.
Decision:
350. Name and address of manufacturer / M/s Jaens Pharmaceutical Industries Pvt Limited.
Applicant 28-km Lahore-Sheikhupura Road, Sheikhupura
Contract Manufacturer
M/s English Pharmaceutical Industries Link
Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore
Brand Name +Dosage Form + Strength Gezole injection I/V 40mg
Composition Each vial contains:
Omeprazole as Sodium (lyophilised)……….40mg
Diary No. Date of R& I & fee Dy. No.16472; 04-05-2018; Rs.50,000/-
DUPLICATE (13-10-2014)
Pharmacological Group Proton pump inhibitor
Pack size & Demanded Price 1’s & Rs. 300/- per vial
Me-too status OmepMine 40mg injection of M/s Lawari
International (Reg. # 069704)
GMP status Applicant:
Grant of additional section dated 08-05-2018.
Manufacturer:
The firm was granted GMP certificate based on
inspection dated 16-01-2018.
Remarks of the Evaluator XIII  Firm showed yellow copy of fee- challan as
an evidence of fees paid.
 Lyophilized injection section of
manufacturer needs confirmation.
 Firm has 12 already registered drugs on
Contract and 08 approved sections.
 No USP or BP monograph is available for
Decision:
351. Name and address of manufacturer / M/s Basel Pharmaceuticals, 227-Phase, Multan
Applicant Industrial Estate, Multan
Contract Manufacturer
M/s English Pharmaceutical Industries Link
Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore
Brand Name +Dosage Form + Strength B- zole injection I/V 40mg
Omeprazole as Sodium (lyophilised)……….40mg
Me-too status OmepMine 40mg injection of M/s Lawari
International (Reg. # 069704)
GMP status Applicant:
27-10-2016 and the status from QA shows “reply
FID to send case to CLB”.
Manufacturer:
The firm was granted GMP certificate based on
Remarks of the Evaluator XIII  Firm showed yellow copy of fee- challan as
an evidence of fees paid.
 Lyophilized injection section of
manufacturer needs confirmation.
 Already registered drugs on Contract and
approved sections need to be confirmed by
the firm.
 GMP status of the applicant needs
confirmation.
 Letter was issued to the firm on 30th
January, 2019 but the firm has not replied
yet.
Decision:
352. Name and address of manufacturer / M/s Biolabs (Pvt.) Limited, Plot # 145, Industrial
Brand Name +Dosage Form + Strength Emtil tablet 250mg
Mycophenolate Mofetil…250mg
Pharmacological Group Immuno-supressant
Pack size & Demanded Price 10’s, 20’s, 30’s, 40’s, 50’s & as per PRC (MOH)
Approval status of product in Reference Could not be confirmed in the applied strength
Regulatory Authorities (available strength is 500mg)
Me-too status Linfonex 250mg tablet of M/s CCL Pharma
(Reg. # 053874)
GMP status GMP certificate was granted based on inspection
conducted on 05 & 06.12.2017.
Remarks of the Evaluator XIII  For the applied formulation, Registration
Board asks manufacturer to provide safety
and protective measures for workers and
personnel which remain in direct contact or
are involved in close handling of these
drugs.
 Firm has General Tablet section as
 Could not be confirmed internationally in
the applied strength (available strength is
500mg).
Decision:
Applicant Punjab Small Industioral Estate, Taxilla.
Brand Name +Dosage Form + Strength Febux tablet 80mg
Febuxostat …………..…..80mg
Diary No. Date of R& I & fee Dy.No.475; 04-01-2018;Rs.20,000/-(04-01-2018)
Pharmacological Group Xanthine Oxidase Inhibitor
Me-too status Febuxin 80mg tablet of M/s AGP Pharma
(Reg. # 081105)
GMP certificate.
Remarks of the Evaluator  Firm has General Tablet section as
Decision:
Brand Name +Dosage Form + Strength Rimeta tablet 35mg
Composition Each modified-release film- coated tablet contains:
Trimetazidine dihydrochloride ……….….…35mg
Pharmacological Group Anti- anginal
Finished product Specification In- house
Approval status of product in Reference Trimetazidine 35mg, modified release film-coated
Regulatory Authorities tablet (ANSM approved)
Me-too status Trikat MR 35mg of Next Pharma (Reg.# 064849)
GMP certificate.
formulation is available in JP.
Decision:
Brand Name +Dosage Form + Strength Colside tablet 4mg
Thiocolchicoside .….….…..4mg
Pharmacological Group Muscle Relaxant
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)
GMP certificate.
 Approved in ANSM (France) as uncoated
tablet while is applied as film-coated.
Decision:
Brand Name +Dosage Form + Strength Etorwen tablet 60mg
Etoricoxib ……………..…60mg
Me-too status Etoria 60mg Table of M/s Hygeia Pharmaceuticals,
(Reg.# 080818)
GMP certificate.
Decision:
357. Name and address of manufacturer / M/s Fedro Pharmaceutical Labs (Pvt.) Limited,
Applicant 149 Industrial Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Rofyl Plus Syrup 45mg+8mg/ 5ml
Acefylline Piperazine…………….……..45mg
Diphenhydramine Hydrochloride……...…8mg
Diary No. Date of R& I & fee Dy. No.471; 04-01-2018; 20,000/-(04-01-2018)
Pharmacological Group Xanthine /Anti-histaminic agent
Type of Form Form-5
Finished product Specification Manufacturer’s
Pack size & Demanded Price 60ml, 90ml & 120ml & as per SRO
Me-too status Acefyl Cough Syrup of M/s Nabi Qasim
(Reg.# 023394 )
2017 and the report concludes renewal of DML.
Remarks of the Evaluator XIII  The firm has General liquid section as is
mentioned in the section approval letter.
 The approval status of the applied
formulation in the reference regulatory
Decision:
358. Name and address of manufacturer / M/s Asian Continental (Pvt.) Ltd., D/32, S.I.T.E.
Applicant Super Highway, Karachi
Brand Name +Dosage Form + Strength Predot tablet 10mg
Domperidone as Maleate …........10mg
Pharmacological Group Anti- emetic/ Anti- vertigo
Pack size & Demanded Price 3x 10’s, 5x 10’s &As per PRC
Me-too status Dompro tablets 10mg of M/s Unison Chemical
Works (Reg. # 050154)
2017 and the report concludes good compliance.
Remarks of the Evaluator XIII  General tablet section as is mentioned in
the GMP inspection report.
formulation is available in BP.
Decision:
Brand Name +Dosage Form + Strength Acbedol tablet 37.5mg/ 325mg
Tramadol HCl………….37.5mg
Paracetamol…………..... 325mg
Pack size & Demanded Price 1x 10’s & as per PRC
Approval status of product in Reference Tramacet 37.5mg/ 325mg film-coated tablet of M/s
Regulatory Authorities Grunenthal Limited (MHRA Approved)
Me-too status Tonoflex-P of M/s Sami Pharmaceuticals (Reg.#
067163)
Decision:
Brand Name +Dosage Form + Strength Ac- tidal capsule 50mg
Tramadol HCl.....50mg
Approval status of product in Reference Tramadol 50 mg capsules, hard by M/s Milpharm
Regulatory Authorities Limited (MHRA Approved)
Me-too status Tramal capsule 50mg by Impex Plus Karachi (Reg.
# 010170)
formulation is available in BP.
Decision:
361. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt. Limited, Plot #
Applicant 11, Sector 12-A, North Karachi Industrial Area,
Karachi.
Brand Name +Dosage Form + Strength Semolax tablet 5mg
Composition Each enteric-coated tablet contains:
Bisacodyl …………………....5mg
Pharmacological Group Laxative
Pack size & Demanded Price 20’s, 60’s, 100’s, 500’s, 1000’s & as per PAC
Me-too status Bisacodyl tablet 5mg of M/s Ferozesons Pharma
(Reg. # 002878)
compliance.
Decision:
Karachi.
Brand Name +Dosage Form + Strength Oxetine CR tablet 25mg
Composition Each enteric- coated controlled –release tablet
contains:
Paroxetine as Hydrochloride……………25mg
Pack size & Demanded Price 10’s, 15’s, 20’s, 30’s & as per PAC
Me-too status Paroxin CR tablet 25mg of Shrooq Pharma
(Reg. # 060470)
compliance.
Decision:
Karachi.
Brand Name +Dosage Form + Strength Oxetine CR tablet 12.5mg
contains:
Paroxetine as Hydrochloride…………12.5mg
Pack size & Demanded Price 10’s, 15’s, 20’s, 30’s & as per PAC
Me-too status Paroxin CR tablet 12.5mg of Shrooq Pharma
(Reg. # 060471)
compliance.
Decision:
Karachi.
Brand Name +Dosage Form + Strength Oxetine CR tablet 37.5mg
contains:
Paroxetine as Hydrochloride……………37.5mg
Pack size & Demanded Price 10’s, 20’s, 30’s & as per PAC
Me-too status Deroxat CR 37.5mg tablets of M/s Global Pharma
(Reg. # 069948)
compliance.
Decision:
365. Name and address of manufacturer / M/s Wilson’s Pharmaceuticals, 387- 388, I-9
Applicant Industrial Area, Islamabad.
Brand Name +Dosage Form + Strength Talergin EB Syrup
Ebastine ….....5mg
Pharmacological Group Anti- histamine
Pack size & Demanded Price 30ml & 60ml / bottle & as per SRO
Me-too status Fystine Liquid Syrup of M/s Fynk Pharma
(Reg. # 077173)
2018 and the report concludes very good level of
GMP compliance.
Remarks of the Evaluator XIII  Firm has Oral Liquid General Section as
 No USP, BP or JP monograph is available
for the applied formulation.
 Internationally, the applied formulation
could not be confirmed.
Decision:
Brand Name +Dosage Form + Strength Lorin- P tablet
Composition Each extended- release tablet contains:
Loratadine………………………5mg
Pseudoephedrine Sulphate…...120mg
Pharmacological Group Anti- histamine/ Sympathomimetic (Nasal
Decongestants)
Pack size & Demanded Price 1x 10’s, 3x 10’s & as per PRC
Me-too status Could not be confirmed as extended- release
tablet
 Me- too could not be confirmed as
extended- release tablet.
Decision:
367. Name and address of manufacturer / M/s Aspin Pharma (Pvt.) Limited, Plot # 10 & 25,
Applicant Sector 20, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Obglyza tablet 2.5mg
Saxagliptin as Hydrochloride …..2.5mg
Pharmacological Group Anti- diabetic
Pack size & Demanded Price 7’s, 10’s, 14’s, 30’s & as per DPC
Me-too status Saxagen tablet 2.5mg of M/s Genix Pharma
(Reg. # 076644)
2017 and the report concludes satisfactory
compliance.
 Firm has General Tablet Section as
Decision:
368. Name and address of manufacturer / M/s Aspin Pharma (Pvt.) Limited, Plot # 10 & 25,
Brand Name +Dosage Form + Strength Obglyza tablet 5mg
Saxagliptin as Hydrochloride …..5mg
Pharmacological Group Anti- diabetic
Pack size & Demanded Price 7’s, 10’s, 14’s, 30’s & as per DPC
Me-too status Saxagen tablet 5mg of M/s Genix Pharma
(Reg. # 076643)
compliance.
 Firm has General Tablet Section as
Decision:
369. Name and address of manufacturer / M/s Neutro Pharma (Pvt.) Limited, 9.5 Km,
Brand Name +Dosage Form + Strength Truace tablets 37.5mg/ 325mg
Tramadol ………………37.5mg
Paracetamol……………..325mg
Diary No. Date of R& I & fee Dy. No. 31372; 17-09-2018; Rs.8,000/- (30-11-
2010)+ Rs.12,000/- (10-11-2017) DUPLICATE
Pharmacological Group Analgesic/ Opiate Analogue
Type of Form Form-5
Pack size & Demanded Price 2x 5’s, 10’s, 2x 10’s, 10x 10’s & as per SRO
Me-too status Tramadoln Plus tablet 37.5mg/ 325mg of M/s
Akson Pharma (Reg. # 085459)
GMP status Last GMP inspection was conducted on 21 & 23-
08-2017 and the report concludes renewal of DML.
Remarks of the Evaluator  Firm has tablet General section as
mentioned in the inspection report.
 Firm has shown its yellow copy as an
evidence of fees paid.
Decision:
370. Name and address of manufacturer / M/s Neutro Pharma (Pvt.) Limited, 9.5 Km,
Brand Name +Dosage Form + Strength Nuprofen SR tablet 800mg
Ibuprofen……………….800mg
2010)+ Rs.12,000/- (10-11-2017) DUPLICATE
Pack size & Demanded Price 30’s, 60’s, 24’s & as per SRO
Approval status of product in Reference Brufen Retard tablet 800mg of M/s Mylan Products
Regulatory Authorities Limited (Approved in MHRA as sustained-release
tablet)
Me-too status Could not be confirmed in the applied strength
(available strengths are 200mg, 400mg & 600mg)
GMP status Last GMP inspection was conducted on 21 & 23-
08-2017 and the report concludes renewal of DML.
Remarks of the Evaluator  The official monograph for the applied
formulation is available in International
Pharmacopoeia.
 Firm has tablet General section as
mentioned in the inspection report.
 Firm has shown its yellow copy as an
evidence of fees paid.
 Firm has applied the formulation as film-
coated tablet while in reference regulatory
authorities, it is approved as sustained-
release tablet.
 Me- too product could not be confirmed in
the applied strength.
Decision:
371. Name and address of manufacturer / M/s ARP (Pvt.) Limited, Plot # 12 & 12A, Street
Applicant No. W-3, National Industrial Zone , Rawat
Brand Name +Dosage Form + Strength Infecnil tablet 250mg
Ciprofloxacin as HCl..…..250mg
Me-too status Novidat 250mg tablet of M/s Sami Pharma
(Reg. # 011836)
GMP status GMP certificate (valid up to 05-10-2018) was
issued on the basis of inspection conducted on
06.10.2017.
Remarks of the Evaluator XIII  General Tablet Section is available in the
firm as mentioned in the section approval
letter.
Decision:
372. Name and address of manufacturer / M/s ARP (Pvt.) Limited, Plot # 12 & 12A, Street
Applicant No. W-3, National Industrial Zone , Rawat
Brand Name +Dosage Form + Strength Infecnil tablets 750mg
Ciprofloxacin as HCl..…..750mg
Me-too status Novidat 250mg tablet of M/s Sami
GMP status GMP Certificate (valid up to 05-10-2018) was
issued on the basis of inspection conducted on
06.10.2017.
letter.
Decision:
373. Name and address of manufacturer / M/s Fas Pharmaceuticals (Pvt.) Limited, Plot # F-
Applicant 748/ L S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Fensedal CF tablet
Paracetamol …………………..500mg
Pseudoephedrine HCl…………..60mg
Chlorpheniramine Maleate ……...4mg
Pharmacological Group Anti-pyretic / Analgesic/ decongestant/ Anti-
histamine
Me-too status Panafin-CF tablet of M/s Medipak (Reg. # 023954)
compliance.
letter.
 The applied formulation could not be
confirmed internationally.
formulation is not available in USP, BP or
JP.
Decision:
374. Name and address of manufacturer / M/s Espoir Pharmaceutical , Laboratory
Applicant Complex, University Road, Karachi
Brand Name +Dosage Form + Strength Vidogip tablets 50mg
Vildagliptin ……………....50mg
Pack size & Demanded Price 2x 14’s & As per DRAP policy
Approval status of product in Reference GALVUS (Vildagliptin 50 mg tablets un-coated)
Regulatory Authorities by Novartis Pharmaceuticals Australia Pty Ltd.
TGA approved
Me-too status V- Glip 50mg uncoated tablet of M/s Wellborne
Pharma (Reg. # 080908)
compliance with assurance of earlier compliance
against the observations being observed during
inspection.
inspection report.
 Firm has applied as film- coated tablet
while the formulation is approved in
reference regulatory authority as uncoated
tablet.
Decision:
Brand Name +Dosage Form + Strength Maxicam tablet 7.5mg
Meloxicam ………………7.5mg
Diary No. Date of R & I & fee Dy.No.7180;26-02-2018; Rs.20,000/- (23-02-2018)
Pharmacological Group Anti- inflammatory/ Anti- rheumatic
Pack size & Demanded Price 10’s & as per brand leader
Approval status of product in Reference Approved
Me-too status Artex un-coated tablet of M/s Pharmedic
(Reg. # 023939)
inspection.
inspection report.
 The applied formulation is approved as
uncoated in USFDA and dispersible in
MHRA while the firm has applied the
formulation as film-coated tablet.
Decision:
Brand Name +Dosage Form + Strength Maxicam tablet 15mg
Meloxicam ……………….15mg
Pharmacological Group Anti- inflammatory/ Anti- rheumatic
Pack size & Demanded Price 10’s & as per DRAP policy
Me-too status Artex un-coated tablet of M/s Pharmedic
(Reg. # 023940)
inspection.
inspection report.
 The applied formulation is approved as
uncoated in USFDA and dispersible in
MHRA while the firm has applied the
formulation as film-coated tablet.
Decision:
377. Name and address of manufacturer / M/s Welmark Pharmaceuticals. Plot #122 Phase
Applicant 5, Block B, Industrial Estate Hattar
Brand Name +Dosage Form + Strength Welosamide 150mg Tablet
Lacosamide……………………………..…150mg
Diary No. Date of R& I & fee Dy. No.7189; 26-02-2018;Rs.20,000/-(23-02-2018)
Type of Form Form-5
Finished product Specification USP specification
Approval status of product in Reference Vimpat film-coated tablets of M/s UCB Pharma,
Regulatory Authorities UK (MHRA Approved)
Me-too status Lacolep 150mg Tablets by Hilton Pharma
(Reg. # 073859)
renewal of DML.
 Firm has applied USP specifications while
no USP or BP monograph is available for
Decision:
Brand Name +Dosage Form + Strength Welosamide 200mg Tablet
Lacosamide…………………..…………...200mg
Type of Form Form-5
Approval status of product in Reference Vimpat film-coated tablets of M/s UCB Pharma,
Me-too status Lacolep 200mg Tablets by Hilton Pharma
(Reg. # 073860)
renewal of DML.
 Firm has applied USP specifications while
no USP or BP monograph is available for
Decision:
379. Name and address of manufacturer / M/s Macter International Ltd., F-216, S.I.T.E,
Applicant Karachi
Brand Name +Dosage Form + Strength Pen- V tablet 250mg
Penicillin-V (Phenoxymethyl Penicillin) as
Potassium …………………….……250mg
Diary No. Date of R& I & fee Dy. No.231;02-01-2018; Rs.20,000/- (02-01-2018)
Pack size & Demanded Price Rs. 400/- for 50’s & Rs. 760/- for 100’s
Approval status of product in Reference Penicillin VK tablets 250 mg of M/s Sandoz
Regulatory Authorities Limited (MHRA Approved)
Me-too status Penicillin-V tablet 250mg of M/s Lisko
(Reg. # 011959)
compliance.
Decision:
380. Name and address of manufacturer / M/s Macter International Ltd., F-216, S.I.T.E,
Applicant Karachi
Brand Name +Dosage Form + Strength Pen- V tablet 500mg
Penicillin-V (Phenoxymethyl Penicillin) as
Potassium …………………….……500mg
Pack size & Demanded Price Rs. 600/- for 50’s & Rs. 1140/- for 100’s
Me-too status Penicillin-V tablet 250mg of M/s Lisko
(Reg. # 011959)
compliance.
Decision:
Pakistan
Brand Name +Dosage Form + Strength Zayzine Syrup 5mg/ 5ml
Cetirizine Di-hydrochloride………5mg
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml & Rs. 30/-, Rs. 58/-
Approval status of product in Reference Benadryl Allergy Children's 1mg/ml Oral Solution
Regulatory Authorities of M/s McNeil Products Ltd (MHRA Approved)
Me-too status Calzine Syrup of M/s Caliph Pharma
(Reg. # 080402)
compliance.
Remarks of the Evaluator XIII  Firm has relevant section i.e. “Oral liquid”
as mentioned in the submitted GMP report.
Decision:
Pakistan
Brand Name +Dosage Form + Strength Zayfyl Syrup 45mg/ 8ml
Acefylline Piperazine…45mg
Diphenhydramine………8mg
Pharmacological Group Xanthine/ Anti-histamine
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml & Rs.43/-, Rs.22/-
Me-too status Acefyl cough syrup 45mg/ 8mg of M/s NabiQasim
(Reg. # 023394)
compliance.
Remarks of the Evaluator XIII  Firm has relevant section i.e. “Oral liquid”
as mentioned in the submitted GMP report.
 No official monograph is avialable for the
applied formulation.
 Approval in reference regulatory
Decision:
383. Name and address of manufacturer / M/s. Zafa Pharmaceuticals Laboratories (Private)
Applicant Limited, L-4/1, A & B Block 21, Federal-B
Industrial Area, Karachi
Brand Name +Dosage Form + Strength Ibudex Tablet 200mg
Dexibuprofen ………...…200mg
Pharmacological Group Anti- rheumatic
Approval status of product in Reference Atriscal 200 mg - film-coated tablets of M/s Gebro
Regulatory Authorities Pharma GmbH, Approved in Austria
Me-too status Haltrin 200mg Tablet of M/s Brookes Pharma
(Reg. # 061068)
GMP status GMP certificate was issued on 15-05-2018 on the
basis of inspection conducted on 25-01-2018.
Remarks of the Evaluator XIII  No official monograph is available for the
applied formulation in USP, BP or JP.
Decision:
384. Name and address of manufacturer / M/s Zafa Pharmaceuticals Laboratories (Private)
Applicant Limited, L-4/1, A & B Block 21, Federal-B
Brand Name +Dosage Form + Strength Ibudex Tablets 400mg
Dexibuprofen ………...…400mg
Pharmacological Group Anti- rheumatic
Me-too status Vanit 400mg tablet of M/s Getz Pharma
(Reg. # 061487)
GMP status GMP certificate was issued on 15-05-2018 on the
basis of inspection conducted on 25-01-2018.
Remarks of the Evaluator XIII  No official monograph is available for the
applied formulation in USP, BP or JP.
Decision:
Brand Name +Dosage Form + Strength Weldrate 5mg Tablet
Risedronate Sodium…….....5mg
Pharmacological Group Bisphosphonate (to prevent bone reabsorption)
Type of Form Form-5
Me-too status Actonel 5mg tablet of M/s Sanofi Aventis Pharma
(Reg. # 027337)
renewal of DML.
Remarks of the Evaluator XIII Firm has General tablet section as mentioned in the
GMP inspection report.
Decision:
Risedronate as Sodium…..35mg
Type of Form Form-5
Me-too status Actonel 35mg tablet of M/s Sanofi Aventis Pharma
(Reg. # 031387)
renewal of DML.
Decision:
Risedronate Sodium…….150mg
Type of Form Form-5
Me-too status Actonel 150mg tablets of M/s Sanofi Aventis
renewal of DML.
Decision:
388. Name and address of manufacturer / M/s Welmed Pharmaceuticals Industries (Pvt.)
Applicant Ltd., Plot No. 108, R-02, Industrial Estate Gadoon,
Dist. Swabi, KPK
Brand Name +Dosage Form + Strength Welfine tablet 125mg
Terbinafine as HCl…...125mg
Pharmacological Group Anti-fungal
Pack size & Demanded Price 7’s, 14’s, 28’s & as per SRO
Approval status of product in Reference TGA Australia Approved as uncoated tablet
Me-too status Afert tablet 125mg of M/s Genix (Reg. # 055856)
and the report concludes renewal of DML.
Remarks of the Evaluator XIII  Film-coating is applied in the master
formulation while the applied formulation
is uncoated and approved in reference
regulatory authority as uncoated as well.
Decision:
389. Name and address of manufacturer / M/s Welmed Pharmaceuticals Industries (Pvt.)
Applicant Ltd., Plot No. 108, R-02, Industrial Estate Gadoon,
Dist. Swabi, KPK
Brand Name +Dosage Form + Strength NT-Wel tablet 500mg
Nitazoxanide …………...500mg
Pharmacological Group Anti- amoebic/ Anti- protozoal
Pack size & Demanded Price 20’s & As per SRO
Me-too status Izato 500mg tablet of M/s Sami Pharma
(Reg. # 076308)
and the report concludes renewal of DML.
Remarks of the Evaluator XIII Firm has claimed USP specifications while the
applied formulation is non- pharmacopoeial.
Decision:
390. Name and address of manufacturer / M/s Revive Pharmakon, Adda Plot Sharaiz
Applicant Avenue Jatti Umra, 10km Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Revasol M- 20 I/V Infusion 500ml
Mannitol …….………..20g (20%)
Pharmacological Group Antiglaucoma , Diuretic
Me-too status Mannitol solution 20% of M/s Imran & CO,
and the report concludes the firm to be GMP
compliant.
Decision:
391. Name and address of manufacturer / M/s Ipram International, Plot # 26, S.S 3, National
Applicant Industrial Zone Rawat, Islamabad.
Brand Name +Dosage Form + Strength Iprolac 10mg/ 1ml I/V I/M Injection
Ketorolac Tromethamol ……..10mg
Pharmacological Group NSAIDs
Pack size & Demanded Price 1ml x 5’s ampoules & as per SRO
Approval status of product in Reference Toradol Ketorolac Trometamol 10mg/1ml injection
Regulatory Authorities ampoule of M/s Atnahs Pharma Australia Pty Ltd
(TGA Approved)
Me-too status Ketopan injection 10mg/ ml of M/s Welwrd
GMP status 16-02-2017 and grant of additional sections was
granted in the report.
Decision:
Evaluator PEC-XIV
392. Name and address of manufacturer / M/s Weatherfolds Pharmaceuticals, Plot # 69, Phase-
Applicant II, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Go-Peptic Suspension
Sucralfate……………1000mg
Diary No. Date of R& I & fee 1880, 18-01-2018, 20,000/-, 04-01-2018
Pharmacological Group Cytoprotective agent
Type of Form Form-5
Approval status of product in Reference Approved by MHRA of UK
Me-too status Sucralate Oral Liquid suspension of M/s Regal Pharma
(Reg.#081988)
overall the firm was GMP compliant as per DRAP
guidelines
Decision:
Brand Name +Dosage Form + Strength ALPHA-C 0.25mcg Tablet
Alfacalcidol………………0.25mcg
Pharmacological Group Vitamin D3 analogue
Type of Form Form-5
Pack size & Demanded Price As per SRO; As per SRO
Approval status of product in Reference PMDA approved.
Me-too status Alfa-D Tablets 0.25mcg of Platinum (Reg#028124)
guidelines
Decision:
Brand Name +Dosage Form + Strength Fusid 250mg Tablet
Sodium Fusidate………………250mg
Pharmacological Group Steroid Antibacterials;
ATC code: J01XC01
Type of Form Form-5
Me-too status Fucidin Tablet of LEO Pharma
guidelines
Decision:
395. Name and address of manufacturer / M/s McOlson Research Laboratories (Pvt.) Ltd. 26th
Applicant KM Lahore- Sharikpur Road Sheikhupura
Brand Name +Dosage Form + Strength McFAX 50mg Tablet
Venlafaxine as hydrochloride…………….50 mg
Pharmacological Group SSNRI (Antidepressant)
Type of Form Form-5
Pack size & Demanded Price 20’s; As per SRO
Approval status of product in Reference Venlafaxine Hydrochloride 50mg tablets by M/s Teva
Regulatory Authorities. Pharmaceuticals USA (USFDA Approved)
Me-too status Amfax 50mg Tablets by M/s Amson (Reg#029070)
GMP status GMP inspection conducted on 10-04-2017 & 24-04-2017
concluded that in overall consideration firm has fair
compliance of GMP, however some advises are also
given in the report to the firm for further up-gradations.
Decision:
Brand Name +Dosage Form + Strength McFAX 37.5mg Tablet
Venlafaxine as hydrochloride…………….37.5 mg
Pharmacological Group SSNRI (Antidepressant)
Type of Form Form-5
Approval status of product in Reference EFFEXOR of Pfizer (USFDA)
Me-too status EFEXOR of Pfizer
Decision:
Brand Name +Dosage Form + Strength Valmac 80 mg Tablet
Composition Each Film coated Tablet contains:
Valsartan………………….80mg
Pharmacological Group Angiotensin II receptor Antagonist
Type of Form Form-5
Approval status of product in Reference Approved by USFDA
Me-too status DIOVAN tablets 80 by M/s Novartis Pharma
(Reg#027346)
Decision:
Brand Name +Dosage Form + Strength Valmac 160 mg Tablet
Pharmacological Group Angiotensin II receptor Antagonist
Type of Form Form-5
Me-too status DIOVAN tablets 160 by M/s Novartis Pharma Karachi
(Reg.#027347)
Decision:
Brand Name +Dosage Form + Strength Co-Valmac 80/12.5 mg Tablet
Hydrochlorothiazide………..12.5mg
Pharmacological Group Angiotensin II Receptor Antagonist and diuretic
Type of Form Form-5
Approval status of product in Reference Diovan HCT Tablet by Novartis
Regulatory Authorities. (USFDA Approved)
Me-too status Co-Diovan Tablets by Novartis
Decision:
Brand Name +Dosage Form + Strength Co-Valmac 160/12.5 mg Tablet
Hydrochlorothiazide………..12.5mg
Type of Form Form-5
Me-too status Sofvasc-HCT Tablet of Wilson Pharma (Reg.# 077749)
Decision:
Brand Name +Dosage Form + Strength Co-Valmac 160/25 mg Tablet
Hydrochlorothiazide………..25mg
Type of Form Form-5
Me-too status Sofvasc-HCT Tablet of Wilson Pharma (Reg.# 077753)
Decision:
Brand Name +Dosage Form + Strength M-SART 50 mg Tablets
Losartan Potassium……………..50mg
Pharmacological Group Angiotensin II Receptor Antagonist
Type of Form Form-5
Approval status of product in Reference Cozaar by MSD (MHRA Approved)
Me-too status Cozaar by OBS
Decision:
403. Name and address of manufacturer / M/s Akhai Pharmaceuticals (Pvt.) Ltd, plot # A-248 &
Applicant A-256 to A-259, H.I.T.E. Lasbela Balochistan,
Pakistan
Brand Name +Dosage Form + Strength ZIDAN 4mg TABLET
Tizanidine as hydrochloride……….4mg
Type of Form Form-5
Approval status of product in Reference MHRA approved
Me-too status Musidin 4mg Tablet of M/s Martin Dow
GMP status The firm is granted GMP Certificate is issued based on
Decision:
404. Name and address of manufacturer / M/s Akhai Pharmaceuticals (Pvt.) Ltd, plot # A-248 &
Applicant A-256 to A-259, H.I.T.E. Lasbela Balochistan,
Pakistan
Brand Name +Dosage Form + Strength ZIDAN 2mg TABLET
Tizanidine as hydrochloride……….2mg
Type of Form Form-5
Me-too status Tandolax 2mg Tablet M/s High-Q Pharmaceuticals
GMP status The firm is granted GMP Certificate is issued based on
Decision:
405. Name and address of manufacturer / M/s EPHARM Laboratories, A-40, Road No. 1.
Applicant S.I.T.E, Super Highway Industrial Area, north
Karachi
Brand Name +Dosage Form + Strength TELTAN-80mg TABLETS
Telmisartan………….80mg
Pharmacological Group Angiotensin II receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s; As per SRO
1 × 14’s; As per SRO
Me-too status Tasmi 80mg tablet of M/s Getz Pharma (Reg. # 047483)
GMP status GMP inspection dated 27-04-2017 concluded that panel is
of the view to recommend the grant of GMP certificate of
this site.
Decision:
Karachi
Brand Name +Dosage Form + Strength TELTAN-40mg TABLETS
Telmisartan………….40mg
Type of Form Form-5
Me-too status Tasmi 40mg tablet of M/s Getz Pharma (Reg. # 047482)
this site.
Decision:
Karachi
Brand Name +Dosage Form + Strength RUSTATIN-20mg TABLET
Rosuvastatin as calcium………….20mg
Type of Form Form 5
Finished product Specification Firm has claimed in house specification
Pack size & Demanded Price 1x10’s: As per SRO
Approval status of product in Reference Crestor 20 mg film-coated tablets by AstraZeneca UK
Me-too status Rolip 20mg Tablets by Hilton Pharma (Reg# 042354)
this site.
Decision:
Karachi
Brand Name +Dosage Form + Strength RUSTATIN-10mg TABLET
Rosuvastatin as calcium………….10mg
Type of Form Form 5
Approval status of product in Reference Crestor 10 mg film-coated tablets by AstraZeneca UK
Me-too status Rolip 10mg Tablets by Hilton Pharma (Reg# 042353)
this site.
Decision:
Karachi
Brand Name +Dosage Form + Strength EPTRIL-20mg TABLETS
Lisinopril as dihydrate……………….20mg
Pharmacological Group ACE inhibitor
Type of Form Form 5
2x10’s: As per SRO
Approval status of product in Reference USFDA approved
Me-too status Corace Tablet 20mg of M/s Bosch Pharmaceuticals
this site.
Decision:
Karachi
Type of Form Form 5
Me-too status Corace Tablet 20mg of M/s Bosch Pharmaceuticals
this site.
Decision:
Karachi
Type of Form Form 5
Me-too status Corace Tablet 5mg of M/s Bosch Pharma (Reg#027175)
this site.
Decision:
412. Name and address of manufacturer / M/s Theramed Pharmaceutical (Pvt.) Ltd. 45-Km,
Applicant Multan Road, Lahore
Brand Name +Dosage Form + Strength Loroxi 8mg Tablet
Lornoxicam…………………8mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s; As to be awarded by DRAP
Approval status of product in Reference Acabel 8 mg film-coated tablets by Grünenthal Pharma,
Regulatory Authorities. S.A. (Spain Approved)
Me-too status Recam Tablet 8mg by M/s Regal Pharmaceuticals
(Reg.#081952)
GMP status Panel inspection dated 10.10.2017 recommended renewal
of DML and additional section.
Decision:
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
(Reg#061603)
Decision:
Type of Form Form-5
Me-too status Recam Tablet 8mg by M/s Regal Pharmaceuticals
(Reg.#081952)
Decision:
Brand Name +Dosage Form + Strength Theramet 50/1000mg Tablet
Sitagliptin as phosphate………..50mg
Metformin HCl……………..1000mg
ATC code: A10BD07
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 28’s; As to be awarded by DRAP
Approval status of product in Reference Janumet 50/1000 mg film coated Tablet by Merck
Me-too status Treviamet 50mg + 1000mg Tablet by Getz (Reg#
055444)
Decision:
Brand Name +Dosage Form + Strength Fenid 60/120mg Tablet
Composition Each film coated extended release tablet contains:
Fexofenadine HCl………….60mg
Pseudoephedrine HCl…………..120mg
Pharmacological Group Sympathomimetic,
H1 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 10’s; As to be awarded by DRAP
Approval status of product in Reference ALLEGRA-D (Bi-layered tablet) NDA: 020786. |
Regulatory Authorities. Extended Release; Oral | Over-The-Counter From Sanofi
Aventis; Approved in USFDA.
Me-too status Fexet-D 60Mg/120Mg Tablets of Getz Pharma (Pvt.) Ltd,
Karachi (Reg # 039099)
Decision:
Brand Name +Dosage Form + Strength Losar Plus 100/25mg Tablet
Losartan Potassium ……………..100mg
Hydrochlorothiazide………………25mg
Pharmacological Group Anti-hypertensive (Angiotensin II Receptor Antagonist,
Thiazide Diuretic)
Type of Form Form-5
Approval status of product in Reference Cozaar Comp 100mg/25mg ( MHRA Approved)
Me-too status Lotass Plus 100mg/25mg of M/S Getz pharma
Decision:
Brand Name +Dosage Form + Strength Itomed 50mg Tablet
Itopride hydrochloride…………50m
Pharmacological Group Gastroprokinetic agent
Type of Form Form-5
Approval status of product in Reference Ganaton of M/s Abbott Laboratories (PMDA approved)
Me-too status Itoguard Tablet of M/s Macter Int (Reg#055753)
Decision:
Brand Name +Dosage Form + Strength Losar Plus 50/12.5mg Tablet
Hydrochlorothiazide………………12.5mg
Pharmacological Group Anti-hypertensive (Angiotensin II Receptor Antagonist,
Thiazide Diuretic)
Type of Form Form-5
Approval status of product in Reference Cozaar Comp Tablet by MSD (MHRA Approved)
Me-too status Xavor DIU 50mg/12.5mg of M/s Ferozsons
Decision:
Brand Name +Dosage Form + Strength Losar 100 Tablet
Type of Form Form-5
Approval status of product in Reference Cozaar tablets by MSD (MHRA Approved)
Me-too status Tansin DS by Pharmevo
Decision:
Brand Name +Dosage Form + Strength Losar 50 Tablet
Type of Form Form-5
Approval status of product in Reference COZAAR 50 mg tablet ,Merck Sharp & Dohme UK
Regulatory Authorities. MHRA Approved.
Me-too status Xavor 50mg Tablet by Ferozsons pharma (Reg# 079743)
Decision:
Brand Name +Dosage Form + Strength Losar 25mg Tablet
Type of Form Form-5
Approval status of product in Reference COZAAR 25 mg tablet ,Merck Sharp & Dohme UK
Me-too status Xavor by Ferozsons pharma (Reg # 079742)
Decision:
Brand Name +Dosage Form + Strength Theratin 40mg Tablet
Atorvastatin as calcium trihydrate………….40mg
Pharmacological Group HMG-CoA reductase inhibitor
Type of Form Form-5
Finished product Specification JP specs
Approval status of product in Reference Lipitor 40mg film coated Tablets by Pfizer
Me-too status Lipitor 40mg Tablets by Pfizer (Reg# 023622)
Decision:
Brand Name +Dosage Form + Strength Tiroxin 50mcg Tablet
Composition Each tablet contains :
Thyroxine Sodium……………..50mcg
Pharmacological Group Thyroid supplement
Type of Form Form-5
Finished product Specification BP (as Levothyroxine Tablets)
Approval status of product in Reference Eltroxin 50mcg tablet (Levothyroxine)
Me-too status Thyroxin50mcg of M/s GSK
Decision:
Brand Name +Dosage Form + Strength Ofocin 200mg Tablet
Ofloxacin…………….200mg
Type of Form Form-5
Me-too status A-Vid Tablets 200mg of M/s Alliance Pharma. (Reg.#
043768)
Decision:
Brand Name +Dosage Form + Strength Theriptin 50mg Tablet
Sitagliptin as phosphate…………50mg
Type of Form Form-5
Approval status of product in Reference Januvia tablets of (FDA approved)
Me-too status A-Glip Tablets of M/s Atco Labs
Decision:
Brand Name +Dosage Form + Strength Therazith 250mg Tablet
Azithrmycin Dihydrate eq. to Azithromycin…...250mg
Type of Form Form-5
Approval status of product in Reference Azithromycin 250 mg film-coated tablets by Milpharm
Me-too status Zetro 250mg Tablet by Getz Pharma (Reg# 066913)
Decision:
Brand Name +Dosage Form + Strength Acefenac 100mg Tablet
Aceclofenac………..100mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As to be awarded by DRAP
Me-too status Aclofen Tablets by M/s Alliance Pharma (Reg # 068419)
Decision:
Brand Name +Dosage Form + Strength T-Merz Syrup
L-Ornithine L-Aspartate……….….300mg
Nicotinamide…………………....…24mg
Riboflavin sodium Phosphate……..0.76mg
Pharmacological Group Hepatic Encephalopathy
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml; As to be awarded by DRAP
Me-too status Hepa-Merz by M/s Brookes
Decision:
430. Name and address of manufacturer / M/s FAAS Pharmaceuticals (Pvt.) Ltd., F-748, S.I.T.E,
Applicant Karachi, Pakistan
Brand Name +Dosage Form + Strength Calculix 250mg Capsule
Ursodeoxycholic acid……………..250mg
Pharmacological Group Cholagogues & hepatic preparations
Type of Form Form-5
Pack size & Demanded Price 1×10’s; As per SRO
Approval status of product in Reference Ursogal capsule by Galen Ltd
Me-too status Urso capsule by AGP
GMP status Inspection dated 04-05-2018 concluded that the firm has
complied/ improved according to the directions of the
FID. Panel was satisfied for the improvements undertaken
by the firm to comply with the observations.
Decision:
Brand Name +Dosage Form + Strength Calculix 500mg Capsule
Ursodeoxycholic acid……………..500mg
Pharmacological Group Bile acids and derivatives
Type of Form Form-5
Approval status of product in Reference Ursochol 500 mg capsule, hard
Regulatory Authorities. By Orifarm Generics A/S (Sweden Approved)
Me-too status Urso capsule by AGP
Decision:
Brand Name +Dosage Form + Strength F-REPA 0.5mg Tablet
Repaglinide…………….0.5mg
Type of Form Form-5
Pack size & Demanded Price 1×10’s, 1×30’s; As per SRO
Approval status of product in Reference Prandin 0.5mg Tablet by Gemini Labs LLC approved by
Regulatory Authorities. USFDA
Me-too status Rapaglax Tablets 0.5mg by M/s Cirin Pharmaceuticals
Decision:
Brand Name +Dosage Form + Strength Histego 24mg Tablets
Betahistine Dihydrochloride..………24mg
Pharmacological Group Anti-Vertigo
Type of Form Form-5
Me-too status Vertin 24mg tablets of M/s Libra pharmaceuticals
Decision:
Betahistine Dihydrochloride …………16mg
Type of Form Form-5
Me-too status Vertin 16mg tablets of M/s Remington Pharma (Reg #
071250)
Decision:
Betahistine Dihydrochloride ……………8mg
Type of Form Form-5
Me-too status VR-Tigo Tablets 8mg by Himont Pharmaceuticals (Pvt)
Ltd. (Reg#079703)
Decision:
Brand Name +Dosage Form + Strength IVANODE 5mg Tablets
Ivabradine as hydrochloride…………5mg
Pharmacological Group Anti-anginal
Type of Form Form-5
Me-too status Iva Tablet 5 mg of M/s CSH Pharma (Reg.# 081685)
Decision:
Brand Name +Dosage Form + Strength IVANODE 7.5mg Tablets
Ivabradine as hydrochloride…………7.5mg
Pharmacological Group Anti-anginal
Type of Form Form-5
Me-too status Ivatab Tablet 7.5 mg of M/s Nabiqasim (Reg # 076155)
Decision:
Brand Name +Dosage Form + Strength OMONIC 150mg Tablets
Ibandronate sodium monohydrate eq. to Ibandronic
acid………..150mg
Pharmacological Group Bisphosphonates
Type of Form Form-5
Finished product Specification USP specifications
Approval status of product in Reference USFDA app
Me-too status Bionic Tablets 150mg by M/s S.J.&G. Fazul Ellahie
(Reg.#058637)
Decision:
Brand Name +Dosage Form + Strength Terbifaas 125mg Tablets
Composition Each Tablet contains:
Terbinafine as hydrochloride…………125mg
Type of Form Form-5
Approval status of product in Reference TERBINAFINE 125 mg uncoated tablets Stada
Regulatory Authorities. Arzneimittel AG (MHRA Approved)
Me-too status Lamisil 125mg Tablet by Sandoz (Reg# 013208)
Decision:
Brand Name +Dosage Form + Strength Decoag 15mg Tablet
Rivaroxaban……………15mg
Pharmacological Group Anticoagulant
Type of Form Form-5
Finished product Specification Manufacturer specifications
Approval status of product in Reference Xarelto of M/s Bayer healthcare approved by EMA
Me-too status Xarelto 15mg Tablet by M/s. Bayer Pakistan (private)
limited (Reg#072549)
Decision:
Brand Name +Dosage Form + Strength Decoag 20mg Tablet
Rivaroxaban……………20mg
Pharmacological Group Anticoagulant
Type of Form Form-5
Approval status of product in Reference Rivaroxaban 20 mg film-coated tablets by Milpharm
Regulatory Authorities. Limited. MHRA approved
Me-too status Rivaxo 20mg film-coated Tablet by Getz Pharma
Reg.#80791
Decision:
Brand Name +Dosage Form + Strength RIFAAS 550mg Tablet
Rifaximin………………550mg
Type of Form Form-5
Finished product Specification In-house specifications
Approval status of product in Reference REFERO 550 mg film-coated tablets by Alfasigma S.p.A
Me-too status Xifaxa 550mg Tablet by Brookes Pharm (Reg#070438)-
Decision:
Brand Name +Dosage Form + Strength RIFAAS 200mg Tablet
Rifaximin………………200mg
Type of Form Form-5
Approval status of product in Reference Xifaxanta 200 mg film-coated tablets by Norgine
Regulatory Authorities. Pharmaceuticals Limited (MHRA approved)
Me-too status Rifaxa 200mg Tablets by Ferozsons (Reg . No. 068205)
Decision:
Brand Name +Dosage Form + Strength RHEUMAX 4mg TABLET
Lornoxicam…………….4mg
Type of Form Form-5
Pack size & Demanded Price 1×10’s, 20’s; As per SRO
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
(Reg#061603)
Decision:
Brand Name +Dosage Form + Strength RHEUMAX 8mg TABLET
Lornoxicam…………….8mg
Type of Form Form-5
Pack size & Demanded Price 1×10’s and 20’s; As per SRO
Me-too status Zafon 8mg Tablet by Getz Pharma (Reg# 058589)
Decision:
Brand Name +Dosage Form + Strength Mucyst 200mg Sachet
Acetylcysteine…………….200mg
Pharmacological Group Mucolytic agent
Type of Form Form-5
Pack size & Demanded Price 30’s,; As per SRO
Approval status of product in Reference Acetylcysteine 200 mg Powder for Oral Solution by M/s
Regulatory Authorities. NTC S.r.l. (MHRA approved)
Me-too status Mucolator 200mg powders by M/s Abbott Laboratories.
(Reg# 017693)
Decision:
Brand Name +Dosage Form + Strength Storiosis 2gm sachet
Strontium Ranelate……………..2gm
Pharmacological Group Bone metabolism modulator
Type of Form Form-5
Pack size & Demanded Price 1×7’s ; As per SRO
Approval status of product in Reference PROTOS strontium ranelate 2g granules for oral
Regulatory Authorities. suspension sachet by Servier Laboratories (TGA
Australia Approved)
Me-too status Onita Sachet by PharmEvo (Reg # 057746)
Decision:
448. Name and address of manufacturer / M/s Treat Pharmaceutical industry (Pvt) Ltd., A-37,
Applicant Small Industrial Estate, Township Kohat Road,
Bannu
Brand Name +Dosage Form + Strength Tremgine INJECTION
Methylergometrine as maleate…………..0.2mg
Pharmacological Group Uterotonics
ATC Code: G02AB01
Type of Form Form-5
Pack size & Demanded Price 1ml ampoule; As per SRO
Approval status of product in Reference Methylergonovine Maleate Injection 0.2mg/ml (1ml) by
Regulatory Authorities. American Regent, Inc, USFDA
Me-too status Ergomin Injection 0.2 mg (1ml) Reg # 066614
GMP status
Remarks of the Evaluator. The label claim is not as per Reference product. Revision
of Form-5 is required.
Decision:
449. Name and address of manufacturer / M/s The Searle Company Limited, F-319 SITE,
Brand Name +Dosage Form + Strength HEMONSTIL 500mg/10ml INJECTION
Composition Each 10ml injection contains:
Iron as Ferric Carboxymaltose……………..500mg
Pharmacological Group Haematinic
Type of Form Form 5
Pack size & Demanded Price 1‘s x 10ml / As per SRO
Approval status of product in Reference Injectafer 750 mg iron / 15 mL single-use vial by M/s
Regulatory Authorities. Luitpold Pharms Inc (USFDA Approved)
Me-too status Ferinject 50mg/ml Injectable Vial (10ml) by M/s R.G
Pharmaceutica (Reg#072548)
GMP status Copy of GMP certificate valid upto 05-2019, issued
by Additional Director, DRAP, Karachi has been
submitted.
Remarks of the Evaluator.  Label claim does not clarify quantity of iron in applied
formulation is not as per Reference product.
 Evidence of 10 ml pack size in Reference Regulatory
Authorities is required to be submitted.
Decision:
450. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt.) Ltd. 62-Industrial
Applicant Estate, Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Sita-Met 50/850 Tablet
Sitagliptin as phosphate monohydrate…….50mg
Metformin hydrochloride……………….850mg
ATC Code: A10BD07
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s/ As per SRO
Approval status of product in Reference JANUMET Tablet 50 mg/850 mg by M/s Merck Sharp &
Regulatory Authorities. Dohme (Australia) Pty Limited (TGA approved)
Me-too status S-Gliptin Plus 50mg+850mg Tablet of M/s Barrett
Hodgson (Reg#081619)
Decision:
451. Name and address of manufacturer / M/s ZAFA Pharmaceutical Laboratories (Private)
Applicant Ltd, L1/B Block-22 Federal B Industrial Area,
Karachi.
Brand Name +Dosage Form + Strength Padrone Injection 30mg
Composition Each 10ml vial contains:
Pamidronate Disodium……………30mg
ATC Code: M05BA03
Type of Form Form 5
Approval status of product in Reference Pamisol 30mg/10ml Injection vial of Hospira Australia
Regulatory Authorities. (TGA approved)
Me-too status Pamidria 30 Sterile Freeze Dried Powder of M/s CIPLA
Ltd (Reg#066117)
GMP status GMP certificate issued on the basis of inspection dated
03.01.2018.
Decision:
Karachi.
ATC Code: M05BA03
Type of Form Form 5
Ltd (Reg#066118)
03.01.2018.
Decision:
Karachi.
ATC Code: M05BA03
Type of Form Form 5
Ltd (Reg#066119)
03.01.2018.
Decision:
454. Name and address of manufacturer / M/s Scotmann Pharmaceuticals, 5-D, I-10/3,
Applicant Industrial Area, Islamabad
Brand Name +Dosage Form + Strength Telscot HCT Tablet
Telmisartan…………….40mg
Hydrochlorothiazide…….12.5mg
Pharmacological Group Angiotensin II Receptor Blocker/Thiazide Diuretic
Type of Form Form 5
Approval status of product in Reference Micardis HCT (USFDA approved)
Me-too status Misar-H 40/12.5 Tablets of 'Highnoon Laboratories,
Lahore (Reg # 065688)
GMP status The panel recommended for the grant of GMP certificate
based on inspection dated 14-09-2017 & 21-09-2017.
Remarks of the Evaluator.  The formulation is approved as bilyered tablet in
reference country while applied formulation is single
tablet. Clarification is required.
Decision:
Hydrochlorothiazide…….12.5mg
Type of Form Form 5
Me-too status Misar-H 80/12.5 Tablets of M/s Highnoon Laboratories,
Lahore. (Reg # 065685)
Decision:
Hydrochlorothiazide…….25mg
Type of Form Form 5
Me-too status Misar-H 80/25 Tablets of M/s Highnoon Laboratories,
Lahore. (Reg # 065685)
Decision:
457. Name and address of manufacturer / M/s Brookes Pharma (Private) Limited, 58 & 59,
Brand Name +Dosage Form + Strength Misonil 75 Tablets
Diclofenac sodium……………..75mg
Misoprostol (HPMC dispersion 1%)………..200mcg
Pharmacological Group NSAID with prostaglandin analogue
Type of Form Form 5
Pack size & Demanded Price 20’s; As per brand leader price
Approval status of product in Reference Arthrotec 75 of GD Searle (USFDA approved)
Me-too status Cytopan-75 Tablets by Getz Pharma (Reg#024014)
GMP status GMP inspection dated 11-10-2017 and 16-10-2017
concluded that the firm is considered to be operating at
satisfactory level of compliance.
Remarks of the Evaluator.  Master formulation shows that the tablet consists of an
enteric coated core containing 75mg of diclofenac
sodium surrounded by an outer mantle containing
200mcg misoprostol.
Decision:
Brand Name +Dosage Form + Strength Glucomin SR 2mg/500mg Tablet
Composition Each bilayered tablet contains:
Glimepiride……………..2 mg
Metformin hydrochloride (as sustained release)….500 mg
Pharmacological Group Combinations of oral blood glucose lowering drug
Type of Form Form 5
Pack size & Demanded Price 3 × 10’s; As per brand leader price
Approval status of product in Reference N/A
Me-too status Amaryl M SR tablet of Sanofi Aventis
Remarks of the Evaluator.  Evidence of approval in reference regulatory authority
could not be verified.
Decision:
Brand Name +Dosage Form + Strength Glucomin SR 1mg/500mg Tablet
Composition Each bilayered tablet contains:
Glimepiride……………..1 mg
Metformin hydrochloride (as sustained release)….500 mg
Pharmacological Group Combinations of oral blood glucose lowering drug
Type of Form Form 5
Pack size & Demanded Price 3 × 10’s; As per brand leader price
Me-too status Amaryl M SR tablet of Sanofi Aventis
Remarks of the Evaluator.  Evidence of approval in reference regulatory authority
could not be verified.
Decision:
460. Name and address of manufacturer / M/s Welmed Pharmaceutical Industries (Pvt.) Ltd,
Applicant Plot # 108, R:2 Industrial Estate Gadoon Swabi, KPK
Brand Name +Dosage Form + Strength MONTIMED TABLET 5mg
Montelukast sodium……………5mg
Type of Form Form 5
Pack size & Demanded Price 1 × 10’s; As per DRAP policy
Approval status of product in Reference Montelukast Hexal 5mg Chewable Tablets (MHRA)
Me-too status Montekast 5mg tablet of M/s Global pharmaceutical
GMP status Last GMP inspection dated 12-7-2018 concludes as “All
the observations were discussed with the firm
management and technical persons. They committed to
rectify all the observations. The firm may be considered
to be operating in satisfactory level of cGMP compliance
subject to fulfillment of observations mentioned in the
inspection report”
Recommendations:
The firm should rectify all the observations in the report
in the shortest period of time and convey the same to
QALT division.
Remarks of the Evaluator. Master formulation shows film coating while reference
product is chewable tablet. Clarification is required.\
Label claim is not as per reference product.
Decision:
Brand Name +Dosage Form + Strength WELFINE TABLET
Terbinafine as Hydrochloride………250mg
Pharmacological Group Allylamine antifungal
Type of Form Form 5
Me-too status Neoterbin Tablets 250mg by M/s Neomedix (Reg#
081411)
Recommendations:
QALT division.
Decision:
Brand Name +Dosage Form + Strength WELFENAC TABLET
Aceclofenac……………..100mg
Type of Form Form 5
Me-too status Aclofen Tablets by M/s Alliance Pharmaceuticals (Pvt)
Ltd, (Reg.# 068419)
Recommendations:
QALT division.
Decision:
Brand Name +Dosage Form + Strength Lormed 8mg Tablet
Lornoxicam ……………..8mg
Type of Form Form 5
Regulatory Authorities. S.A. (Spanish agency of medicine and sanitary products)
Me-too status Zafon 8mg Tablet by Getz Pharma (Reg# 058589)
Recommendations:
QALT division.
Decision:
464. Name and address of manufacturer / M/s Paramount Pharmaceuticals, Plot no. 36,
Applicant Industrial triangle, kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength ALLERSAFE Tablet
Montelukast sodium eq. to Montelukast ………..10mg
Ebastine……………………………………10mg
H1 Antihistamine
Type of Form Form-5
GMP status Last GMP inspection was Conducted on 05.05.2017 with
conclusive remarks of Good cGMP compliance.
Remarks of the Evaluator.  Evidence of applied formulation already approved by
DRAP/DCO is required to be submitted.
reference regulatory authority is required to be
submitted.
Decision:
Brand Name +Dosage Form + Strength ALLER-D Tablet
Montelukast sodium eq. to Montelukast………..10mg
Doxofylline………………………………..400mg
Xanthine Derivative
Type of Form Form-5
Remarks of the Evaluator.  Evidence of applied formulation already approved by
DRAP/DCO is required to be submitted.
reference regulatory authority is required to be
submitted.
Decision:
Brand Name +Dosage Form + Strength Dolex Forte Tablets
Paracetamol………………650mg
Orphenadrine citrate………….50mg
Pharmacological Group Analgesic muscle relaxant
Type of Form Form-5
Approval status of product in Reference Pleren Plus Tablets of pharma lab , Peru
Me-too status Nuberol Forte tablets of M/s Searle
Remarks of the Evaluator. Evidence of approval of applied formulation in reference
regulatory authority is required to be submitted.
Decision:
Brand Name +Dosage Form + Strength Fibrate 67mg Capsules
Fenofibrate……………67mg
Pharmacological Group Lipid modifying agents
ATC code: C10AB05
Type of Form Form-5
Approval status of product in Reference Fenofibrate 67 mg capsules by Actavis UK Limited.
Regulatory Authorities. MHRA approved
Me-too status Lipidof 67 Capsule by ACME LABORATORIES
PAKISTAN (PVT) LTD. (Reg. No. 33164)
Decision:
Brand Name +Dosage Form + Strength Fibrate 200mg Capsules
Fenofibrate……………200mg
Pharmacological Group Lipid modifying agents
ATC code: C10AB05
Type of Form Form-5
Approval status of product in Reference Fenofibrate 200mg capsules by Rhodes Pharms. US-FDA
Regulatory Authorities. approved
Me-too status Felip 200mg Capsule by Bosch Pharmaceuticals (Pvt)
Ltd. Reg. No. 55918
Decision:
Brand Name +Dosage Form + Strength Dutine 60mg Capsules
Duloxetine as Hydrochloride (EC pellets
20%)…………..60mg
ATC code: N06AX21
Type of Form Form-5
Me-too status Dulan (Duloxetine 60 mg capsule) by M/s Hilton
Pharma.(Reg#055448)
Remarks of the Evaluator. Source of pellets is required to be submitted.
Decision:
Brand Name +Dosage Form + Strength Dutine 30mg Capsules
Duloxetine as Hydrochloride (EC pellets
20%)…………..30mg
ATC code: N06AX21
Type of Form Form-5
Pharma.(Reg#055447)
Remarks of the Evaluator. Source of pellets is required to be submitted.
Decision:
471. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, 14-Km, Adyala Road,
Applicant Post office Dahgal, Rawalpindi
Brand Name +Dosage Form + Strength Medrogest Injectable Suspension
Medroxyprogesterone Acetate…………..150mg
Pharmacological Group Depot Progestogen
Type of Form Form-5
Pack size & Demanded Price 1ml vial ; As per SRO
Approval status of product in Reference Depo-Provera 150 mg/ml by Pfizer Limited (MHRA
Me-too status Medroxy Depo Injection by Global Pharma
the report concludes issuance of GMP certificate for
export purpose.
Remarks of the Evaluator. The firm has provided Liquid injection ampoule
(hormone) section.
Evidence of approval in vial section is required.
Decision:
472. Name and address of manufacturer / M/s Candid Pharmaceuticals Opposite pusrur sugar
Applicant mills Sialkot Road, Pasrur
Brand Name +Dosage Form + Strength KALFEN TABLET 50mg
Diclofenac potassium……………50mg
Type of Form Form-5
Pack size & Demanded Price 2 × 10’s; Rs. 98.00/-
Approval status of product in Reference Diclofenac Potassium 50 mg Tablets (film-coated ) by
Regulatory Authorities. Accord Healthcare Limited Dexcel®-Pharma Ltd.
(MHRA approved)
Me-too status Arnil-P 50mg Tablet by Brookes Pharma, Karachi. (Reg
# 82129)
GMP status Inspection Report dated 15-12-2016 which concludes that
firm was found to be operating at a satisfactory level of
GMP compliance.
Decision:
473. Name and address of manufacturer / M/s Aries Pharmaceuticals, 1-W, Industrial Estate,
Applicant Hayatabad Peshawar, KPK
Brand Name +Dosage Form + Strength FLAGYZOLE Oral Suspension
Metronidazole (as Benzoate)…………….75mg
Furazolidone……………………………25mg
Pharmacological Group Amebicide
Type of Form Form-5
Pack size & Demanded Price 90ml; Rs. 34.00/-
Me-too status Dependal-M suspension of M/s GSK Pharma
GMP status Firm has submitted GMP inspection report dated 4-6-
2018 confirming satisfactory compliance to GMP.
Decision:
474. Name and address of manufacturer / M/s Tayyab laboratories Pvt. Ltd. Plot # 13-A, Street
Applicant N-5, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength DOXIVA SYRUP
Doxofylline……………..100mg
Pharmacological Group Xanthines
ATC code: R03DA11
Type of Form Form-5
Approval status of product in Reference Approved in Italy
Me-too status Agolix 100mg/5ml syrup of Hiranis Pharmaceuticals(Reg
No. 067129)
concluded that overall GMP compliance is good.
Decision:
Brand Name +Dosage Form + Strength Zareka 400mg Tablet
Linezolid………………400mg
Diary No. Date of R& I & fee Dy. No. 4013, 01-02-2018, Rs. 20,000/- 31-01-2018
Pharmacological Group Other antibacterials
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
the firm was considered to be operating at satisfactory
compliance with GMP guideline
Decision:
Brand Name +Dosage Form + Strength Zareka 600mg Tablet
Linezolid…………………..600mg
Pharmacological Group Other Antibacterials
Type of Form Form-5
Me-too status Zyvox Tablets 600mg by Pharmacia (Reg# 028440)
Decision:
Brand Name +Dosage Form + Strength Zareka 100mg/5ml Suspension
Linezolid………………….100mg
Type of Form Form-5
Approval status of product in Reference Zyvox Dry Suspension by Pharmacia (USFDA
Me-too status Nezolid 100mg Suspension by Searle (Reg# 050326)
Decision:
Brand Name +Dosage Form + Strength Teramic 100mg Capsule
Itraconazole…………..100mg
Type of Form Form-5
Me-too status Mukil Capsule 100mg of M/s. Dyson Research
Laboratories (Pvt) Ltd (Reg.# 055356)
Remarks of the Evaluator. Source of pellets: M/s Vision Pharma
Decision:
Brand Name +Dosage Form + Strength Omiloc 20mg Capsule
Omeprazole (as enteric coated pellets)……..20mg
Type of Form Form-5
Me-too status Jumep -20 Capsule of M/s Jupiter Pharma
Decision:
Brand Name +Dosage Form + Strength Omiloc 40mg Capsule
Omeprazole (as enteric coated pellets)……..40mg
Type of Form Form-5
Me-too status Jumep-40 Capsule of M/s Jupiter Pharma
Decision:
481. Name and address of manufacturer / M/s Honig Pharmaceuticals Laboratories. 14-km,
Applicant Adyala Road, Rawalpindi
Brand Name +Dosage Form + Strength Procyl Tablets
Piroxicam Beta Cyclodextrin……….…20mg
Diary No. Date of R& I & fee Dy.No 4172, 02-02-2018, Rs. 20,000/-, 02-02-2018
Pharmacological Group Oxicams
Type of Form Form-5
Approval status of product in Reference BREXIN 20 mg scored tablet by Pierre Fabre
Regulatory Authorities. Medicament (ANSM Approved)
Me-too status Brexin Tablets 20mg by Chiesi (Reg#10637)
GMP status Inspection report 21-12-2017 The panel unanimously
recommended for the renewal of DML.
Remarks of the Evaluator. The label claim is not as per Reference product.
Decision:
482. Name and address of manufacturer / M/s Saturn Pharmaceuticals. 23-km Thokar Raiwind
Applicant Road, Lahore contract manufactured by M/s Synchro
Pharmaceuticals., 77-Industrial Estate, Kot Lakhpat,
Lahore
Brand Name +Dosage Form + Strength Satizime 250mg IM Injection
Ceftriaxone as Sodium…………250mg
Diary No. Date of R& I & fee Dy.No. 4109, 01-02-2018, Rs. 50,000/-, 01-02-2018
Pharmacological Group Third generation Cephalosporin
Type of Form Form-5
Approval status of product in Reference Ceftriaxone 250mg (IM) by Lupin Pharmaceuticals Inc.
Regulatory Authorities. US-FDA approved
Me-too status Unixone Injection (ceftriaxone Sodium) 250mg IM by
Caliph Pharmaceuticals (Pvt.) Ltd. Reg. No. 82556
GMP status Panel inspection of M/s Synchro Pharma dated 29-03-
2016 recommended for renewal of DML.
M/s Synchro pharma has provided Dry Powder For
Injectable Cephalosporin section.
Panel inspection of M/s Saturn pharma dated 16-02-2018
concluded that the firm now seems complied with cGMP
at satisfactory level, hence the panel was of the opinion
that the firm may be allowed for resumption of
production.
Decision:
Lahore
Brand Name +Dosage Form + Strength Satizime 500mg IM Injection
Ceftriaxone as Sodium…500mg
Type of Form Form-5
Approval status of product in Reference Ceftriaxone 500mg (IM) by Lupin Pharmaceuticals Inc.
Regulatory Authorities. US-FDA approved
Me-too status Wincef 500 mg (Ceftriaxone sodium) IM injection by
Wnsfeild Pharmaceuticals. Reg. No. 68371
production.
Decision:
Lahore
Brand Name +Dosage Form + Strength Satizime 1g IV Injection
Ceftriaxone as Sodium…1.0gm
Type of Form Form-5
Approval status of product in Reference Ceftriaxone 1 g (IV) by Lupin Pharmaceuticals Inc. US-
Regulatory Authorities. FDA approved
Me-too status Martixon 1gm (Ceftriaxone sodium) I.V Dry powder
Injection by Alkemy Pharma. Reg. No. 70663
production.
Decision:
Lahore
Brand Name +Dosage Form + Strength Satofer 100mg/5ml Suspension
Cefixime Trihydrate eq. to Cefixime…………100mg
Type of Form Form-5
Finished product Specification USP Specification
Me-too status Stlicef Dry Suspension 100mg/5ml of Treat Pharma
production.
Decision:
Lahore
Brand Name +Dosage Form + Strength Satofer 200mg/5ml Suspension
Cefixime Trihydrate eq. to Cefixime…………200mg
Type of Form Form-5
Me-too status Stlicef Dry Suspension 200mg/5ml of Treat Pharma
production.
Decision:
Lahore
Brand Name +Dosage Form + Strength Satocap 400mg Capsule
Composition Each Capusle Contains:
Cefixime as Trihydrate………………..400mg
Type of Form Form-5
Approval status of product in Reference SUPRAX 400mg capsules by M/s Lupin Pharma
Me-too status Soxime Capsule 400 mg by Swat Pharmaceuticals
(Reg#060128)
production.
Decision:
Brand Name +Dosage Form + Strength Nitza 500mg Tablet
Nitazoxanide………….…500mg
Pharmacological Group Agents against amoebiasis and other protozoal diseases
Type of Form Form-5
Approval status of product in Reference ALINIA® (nitazoxanide) film-coated tablets, for oral use
Regulatory Authorities. by Romark L.C. US-FDA approved
Me-too status Trinide 500mg Tablet by Ferozsons Laboratories Ltd.
Reg. No. 80594
guidelines
Decision:
Brand Name +Dosage Form + Strength Mebifold SR 200mg Capsule
Composition Each Modified Release Capsule Contains:
Mebeverine HCl………………..200mg
Pharmacological Group Anti-spasmodic
Type of Form Form-5
Approval status of product in Reference Mebeverine 200 mg modified release capsules of Aspire
Regulatory Authorities. pharma, UK (MHRA approved)
Me-too status Despas MR Capsule of S.J&G Fazul Ellahie, Karachi
guidelines
Decision:
Brand Name +Dosage Form + Strength Artham 30+180 mg/5ml Suspension
Artemether……………30mg
Lumefantrine………..…180mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Me-too status Arceva-DS Dry Suspension by Sami Pharmaceuticals
guidelines
Decision:
491. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals., Plot # 122, Block A,
Applicant Phase V, Hattar Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Chicowin 4mg Tablet
Thiocolchicoside………………4mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Approval status of product in Reference ANSM approved
Me-too status Myolax tablet of Reko Pharma (Reg#074170)
GMP status Last GMP Inspection conducted on 18-1-2018 in which
panel recommended the renewal of DML.
Remarks of the Evaluator. Applied formulation is Film coated while reference
formulation is uncoated tablet.
Decision:
Brand Name +Dosage Form + Strength Betawin 8mg Tablet
Betahistine Dihydrochloride……………8mg
Type of Form Form-5
Me-too status VR-Tigo Tablets 8mg by Himont Pharmaceuticals (Pvt)
Ltd. (Reg#079703)
Decision:
Brand Name +Dosage Form + Strength Meb Plus 135mg/3.5g Sachet
Composition Each Sachet Contains:
Mebeverine HCl………135mg
Ispaghula Husk……………3.5g
Pharmacological Group Antispasmodics/Laxatives
Type of Form Form-5
Approval status of product in Reference Fybogel Mebeverine effervescent granules by M/s Reckitt
Regulatory Authorities. Benckiser Healthcare (UK) Ltd. (MHRA approved)
Me-too status Colospas Fibro 135mg/3.5g powder by M/s Nabiqasim.
(Reg# 058672)
Decision:
Brand Name +Dosage Form + Strength Terbilet 250mg Tablet
Terbinafine as Hydrochloride……………250mg
Type of Form Form-5
Me-too status Neoterbin Tablets 250mg by M/s Neomedix (Reg#
081411)
Decision:
Brand Name +Dosage Form + Strength Varox 15mg Tablet
Rivaroxaban……………………15mg
Pharmacological Group Factor Xa inhibitor
Type of Form Form-5
Reg.#80790
Decision:
Brand Name +Dosage Form + Strength Varox 20mg Tablet
Rivaroxaban……………………20mg
Pharmacological Group Factor Xa inhibitor
Type of Form Form-5
Reg.#80791
Decision:
Brand Name +Dosage Form + Strength Nebiwin 2.5mg Tablet
Nebivolol as Hydrochloride…………2.5mg
ATC Code: C07AB12
Type of Form Form-5
Approval status of product in Reference Bystolic (uncoated)
Me-too status Nebix 2.5mg tablet by Highnoon
Decision:
Brand Name +Dosage Form + Strength Nebiwin 5mg Tablet
Nebivolol as Hydrochloride…………..5mg
ATC Code: C07AB12
Type of Form Form-5
Me-too status Nebix 5mg Tablets of M/s. Highnoon (Reg#062777)
Decision:
Brand Name +Dosage Form + Strength Nebiwin 10mg Tablet
Nebivolol as Hydrochloride…………..10mg
ATC Code: C07AB12
Type of Form Form-5
Approval status of product in Reference Bystolic Of (USFDA Approved)
Me-too status Nabilox 10mg Tablet of M/s Nabiqasim
Decision:
500. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals.
Applicant Plot # 122, Block A, Phase V, Hattar Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Doxowin 400mg Tablet
Doxofylline…………………..…400mg
Pharmacological Group Other Systemic Drugs for Obstructive Airway Diseases
(Xanthines)
Type of Form Form-5
Approval status of product in Reference DOXOFILLINA ABC 400mg tablet by M/s ABC
Regulatory Authorities. FARMACEUTICI S.p.A (Italian Medicine Agency
approved)
Me-too status Profylline Tablet 400mg by M/s Kaizen (Reg# 073744)
Decision:
501. Name and address of manufacturer / M/s Usawa Pharmaceuticals.
Applicant 146 S.I.Z. Risalpur, KPK, Pakistan
Brand Name +Dosage Form + Strength U-Zolid 600mg Tablet
Linezolid……………………..600mg
Type of Form Form-5
Me-too status Zyvox Tablets 600mg by Pharmacia (Reg# 028440)
GMP status The firm was issued GMP certificate based on inspection
conducted on 08-12-2017.
Decision:
502. Name and address of manufacturer / M/s Caliph Pharmaceuticals Pvt Ltd., Plot # 17,
Applicant Special Industrial Zone, Risalpur, KPK, Pakistan
Brand Name +Dosage Form + Strength Cepmol Extra Tablet
Composition Each tablet Contains:
Paracetamol………………500mg
Caffeine…………………..65mg
Pharmacological Group Analgesic combination
Type of Form Form-5
Approval status of product in Reference Paracetamol Extra Tablets of Wrafton Laboratories
Regulatory Authorities. Limited, UK (MHRA approved)
Me-too status Acetofeb Extra Tablets of M/s Vision Pharmaceuticals
(Reg.#038900)
renewal of DML.
Decision:
503. Name and address of manufacturer / M/s Brookes Pharma Pvt Ltd., 58 & 59, Sector 15,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Pantopep 40mg Tablets
Composition Each Enteric Coated Tablet Contains:
Pantoprazoele Sodium Sesquihydrate eq. to
Pantoprazole……………...40mg
Type of Form Form-5
Approval status of product in Reference PROTONIX (pantoprazole sodium) delayed-release
Regulatory Authorities. tablets, for oral use by Wyeth Pharms. US-FDA approved
Me-too status Pantasa Tablets by Platinum Pharma (Reg.No.030205)
concluded that the firm is considered to be operating
at satisfactory level of compliance.
Decision:
504. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products Pvt Ltd.
Applicant D-122, Sindh Industrial Trading Estate, Karachi
Brand Name +Dosage Form + Strength Vibe 2.5mg Tablet
Nebivolol Hydrochloride eq. to Nebivolol………..2.5mg
ATC Code: C07AB12
Type of Form Form-5
Me-too status Nebix 2.5mg tablet by Highnoon
GMP status GMP inspection dated 05-06-2018 concluded that the
firm is found to be complying at Good level of GMP
compliance at the time of inspection.
Decision:
505. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products Pvt Ltd.
Applicant D-122, Sindh Industrial Trading Estate, Karachi
Brand Name +Dosage Form + Strength Vibe 5mg Tablet
Nebivolol Hydrochloride eq. to Nebivolol………..5mg
ATC Code: C07AB12
Type of Form Form-5
Me-too status Nebix 5mg tablet by Highnoon
GMP status GMP inspection dated 05-06-2018 concluded that the
firm is found to be complying at Good level of GMP
compliance at the time of inspection.
Decision:
506. Name and address of manufacturer / M/s. Genetics Pharmaceuticals Pvt. Ltd.
Applicant 539-A, Sundar Industrial Estate,Raiwind,Lahore
Brand Name +Dosage Form + Strength Vergo 24mg Tablet
Betahistine Dihydrochloride…………24mg
Type of Form Form-5
Me-too status Vertin 24mg tablets of M/s Libra pharmaceuticals
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.
Decision:
507. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd.
Applicant 44,45-B, Korangi Creek Road, Karachi, 75190,
Pakistan
Brand Name +Dosage Form + Strength Fina 5mg Tablet
Finasteride………………..5mg
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form-5
Approval status of product in Reference Proscar Tablet (USFDA Approved)
Me-too status Proscar Tablet of M/s Muller &Phipps (Reg#014068)
GMP status Last GMP inspection report dated 16-02-2018 concluding
“satisfactory level of compliance with cGMP guidelines
as of today. The management was also suggested to
further strengthen stability and analytical sections.”
Decision:
508. Name and address of manufacturer / M/s Lisko Pakistan Pvt Ltd., L-10-D, Block 21,
Applicant Shaheed Rashid Minhas Road, F.B. Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Co-Allset 300/25 mg Tablet
Irbesartan……………….300mg
Hydrochlorothiazide……….25mg
Pharmacological Group Angiotensin II antagonists and diuretics
Type of Form Form-5
Approval status of product in Reference Irbesartan and Hydrochlorthiazide Tablets by Aurobindo
Regulatory Authorities. Pharm (USFDA Approved)
Me-too status Irecon – H Tablet by Barret Hodgson
satisfactory compliance to GMP.
Decision:
509. Name and address of manufacturer / M/s Standpharm Pakistan Pvt. Ltd., 20-km,
Applicant Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Vilip-M Tablet 50/500mg
Vildagliptin…………….50mg
Metformin HCI………….500mg
Type of Form Form-5
Approval status of product in Reference GALVUMET 50/500 film coated tablet by Novartis
Regulatory Authorities. Pharmaceuticals (TGA Australia Approved)
Me-too status Galvus Met 50/500mg Tablets by Novartis (Reg#
078106)
compliance.
Decision:
Brand Name +Dosage Form + Strength Duranol 60mg Capsules
Duloxetine………..…60mg
Pharmacological Group Other antidepressants
Type of Form Form-5
Approval status of product in Reference Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly,
Pharma.(Reg#055448)
compliance.
Decision:
Type of Form Form-5
Pharma.(Reg#055447)
compliance.
Remarks of the Evaluator. Source of pellets
Decision:
Type of Form Form-5
Pharma.(Reg#055446)
compliance.
Remarks of the Evaluator. Source of pellets
Decision:
Brand Name +Dosage Form + Strength Resque 500mg Tablet
Azithromycin…………500mg
Type of Form Form-5
Approval status of product in Reference Azithromycin 500 mg Film-Coated Tablets by TEVA UK
compliance.
Decision:
514. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt Ltd.
Applicant Plot No.11, Sector 12-A, North Karachi, Karachi,
Pakistan
Brand Name +Dosage Form + Strength Sebast 20mg Tablet
Ebastine…………..…20mg
Type of Form Form-5
Approval status of product in Reference Kestine
Regulatory Authorities. Netherlands Approved
Me-too status Antine Tablets 20 mg of M/s Wise Pharma Reg#068792
GMP status Last inspection conducted on 17-10-2017 with good GMP
compliance.
Decision:
515. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt Ltd.
Applicant Plot No.11, Sector 12-A, North Karachi, Karachi,
Pakistan
Brand Name +Dosage Form + Strength Sebast 10mg Tablet
Ebastine…………..…10mg
Type of Form Form-5
Approval status of product in Reference EBASTINE ARROW 10 mg film-coated tablets
Regulatory Authorities. ANSM Approved
Me-too status Nosetine Tablets by Technovision Pharmaceuticals
GMP status Last inspection conducted on 17-10-2017 with good GMP
compliance.
Decision:
b. Deferred cases
Evaluator PEC-II
516. Name and address of manufacturer / M/s Welmed Pharmaceuticals Industries (Pvt.) Ltd.,
Applicant Plot No. 108, R-02, Industrial Estate Gadoon, Dist.
Swabi.
Brand Name +Dosage Form + Strength G-Med tablet 320mg
Other proposed brand names:
Wel-Gem
Gemiwel
Gemifloxacin as mesylate…. ……320mg
Pharmacological Group Anti-biotic
Type of Form Form-5
Me-too status G-Active tablet 320mg of M/s. Dyson Research
Laboratories
GMP status Panel Inspection conducted on 04-03-2017 recommends

renewal of DML
Remarks of the Evaluator.  Latest GMP inspection report conducted within
the period of last one year.
 Clarification regarding quantity of API as salt and
its equivalent weight as base.
 Original fee challan of Rs.20,000/- for
Gemifloxacin 500mg tablets is attached instead
of Gemifloxacin 320mg tablets.
Upon communication of above cited observations firm has
submitted firm has submitted revised master formulation
as under:
“ Each film coated tablet contains:
Gemifloxacin as mesylate…. ……320mg”
 Firm has submitted an undertaking that in the
deposit slip we have mentioned the strength as
500mg tablet instead of 320mg due to typing
error. We will use the above mentioned deposit
slip for G-Med 320mg tablet only.
 Firm has submitted fee of Rs. 20,000/- (Deposit
slip#. 0765528) dated 14-09-2018 for the applied
formulation of Gemifloxacin 320mg tablet.
Previous Decision: Registration Board in its 284th meeting 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.
Evaluation by PEC:  Firm has submitted copy of GMP inspection report
“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:
517. Name and address of manufacturer / M/s Biocef (Pvt). Ltd., 517, Sundar Industrial Estate,
Applicant Lahore
Brand Name +Dosage Form + Strength CEFIA Capsule 200mg
Composition Each Capsule Contains:-

Cefixime (as trihydrate)………….200mg
Diary No. Date of R& I & fee Dy Rs.20,000/- (15-06-2017)
Pharmacological Group Third-generation cephalosporins
Type of Form Form-5
Pack size & Demanded Price 10’s: Rs. 314.0
Approval status of product in Reference Not verifiable
Me-too status Cefim Capsule 200mg of M/s Hilton Pharmaceuticals...
Reg.034664
GMP status New facility DML issued (DML No. 000864, Dated 14-
06-2017)
Remarks of the Evaluator.  Evidence of approval for applied formulation by
reference regulatory authority is required.
Previous Decision: Registration Board in its 272nd meeting deferred for
submission of evidence of approval of applied formulation
meeting.
Evaluation by PEC: Following reference for applied formulation submitted by
firm has been verified:
“Cefixime Normon 200 mg hard capsules EFG” of M/s
Laboratorios Normon, SA Round of Valdecarrizo, 6
28760 Tres Cantos – Madrid Spain approved by
AEMPS of Spain.”
https://cima.aemps.es/cima/publico/detalle.html
(Accessed on 07-02-2019)
Moreover firm has submitted that at the time of

application firm’s name was Biocef which was changed by
Central Licensing Board from Biocef to Curexa Health
vide letter No. F.1-23/2006-Lic dated 09th October, 2017.
Now the firm has submitted new application on Form with
the applicant title as M/s Curexa Health (Pvt.) Ltd. Lahore
details of which are as under
Name and address of manufacturer / M/s Curexa Health (Pvt.) Ltd. Plot No. 517, Sunder
Applicant Industrial Estate, Lahore
Brand Name +Dosage Form + Strength CEFIA Capsule 200mg
Composition Each Capsule Contains:-
Cefixime (as trihydrate)………….200mg
Diary No. Date of R& I & fee Dy. No. 4659 dated 01-02-2019, Rs.20,000/- (01-02-
2019)
Type of Form Form-5
Pack size & Demanded Price 5’s & 10’s; As per SRO
Approval status of product in Reference Cefixime Normon 200 mg hard capsules EFG” of M/s
Regulatory Authorities. Laboratorios Normon, SA Round of Valdecarrizo, 6
28760 Tres Cantos – Madrid Spain approved by AEMPS
of Spain.
Me-too status Cefim Capsule 200mg of M/s Hilton Pharmaceuticals...
Reg.034664
GMP status Copy of GMP certificate issued by Additional Director,
DRAP, Lahore issued on the basis of inspection
conducted on 20-02-2018.
Decision:
518. Name and address of manufacturer / M/s. Farmigea Pakistan (Pvt) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Ocupatol 0.2% Eye Drops
Composition Each ml contains:-
Olopatadine HCl equivalent to Olopatadine ……. 0.2%
Diary No. Date of R& I & fee Dairy No.8990 dated 15.07.2013 Rs:20,000/-
Pharmacological Group Anti-allergic
Type of Form Form-5
Pack size & Demanded Price Rs. 275; 5ml
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.
confirmation of container closure system whether as per
innovator or otherwise
Evaluation by PEC: Firm has submitted that they will be using same container
closure system as that of the reference product.
Decision:
Applicant
Brand Name +Dosage Form + Strength Levoflox Eye Drop
Levofloxacin as hemihydrate ….…0.5% w/v
Diary No. Date of R& I & fee Dairy No.8994 dated 15.07.2013 Rs:20,000/-
Pharmacological Group anti biotic/ floroquinolone
Type of Form Form-5
Me-too status Xeflox Eye Drops 0.5% by M/s Helix Pharma, Karachi
(Reg.# 042189)
confirmation of container closure system whether as per
innovator or otherwise
Decision:
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)
following:
i. Confirmation of container closure system whether
as per innovator or otherwise
ii. Clarification of dosage form as reference product
is available as eye drops, suspension
Moreover firm has submitted that it is a typographical
error mentioning it as a gel. The product is in Eye drop
suspension form.
Decision:
521. Name and address of manufacturer / "M/s Pharmevo Private Limited. Plot # A-29, North
Applicant Western Industrial Zone, Port Qasim, Karachi"
Brand Name +Dosage Form + Strength Duzalta 40mg Capsule
Composition Each Delayed Release Capsule Contains:
Enteric Coated Pellets of Duloxetine HCL Eq. to
Duloxetine……40mg
Diary No. Date of R& I & fee Dy. No 1637 dated 11-01-2018 Rs. 20,000 Dated 10-01-
2018
Type of Form Form-5
Me-too status Worth 40 mg Capsules of M/s Werrick pharmaceuticals.
(Reg.# 068816)
GMP status Last GMP inspection report dated 23-02-2018 concluding
acceptable level of compliance with GMP standards as
today
Remarks of the Evaluator. Source of pellets from M/s Alphamed Formulations Pvt.,
Ltd., Sy. No. 225, Sampanabole (V) Sahmirpet (M),
Ranga Reddy, Dist., 500 078, Telangana State. India
GMP certificate valid upto 13-12-2018
differential fee for import of pellets
Evaluation by PEC: Firm has submitted following:
 Fee of Rs. 100,000/- vide deposit slip#0702567
dated 21-01-2019, for import of pellets.
 Stability data for three batches of duloxetine
pellets for both long term & accelerated storage
conditions as per Zone IV-A from M/s Alphamed
Formulations Pvt., Ltd., india.
Decision:
Evaluator PEC-III
522. Name and address of M/s Seatle (Pvt) Ltd., 45 KM, Multan Road, Lahore.
Brand Name +Dosage Form + Setaxin Tablet 250mg
Strength
Levofloxacin as hemihydrate eq to levofloxacin…..250mg
Diary No. Date of R& I & fee Dy No. 198: 09-12-2015
PKR 20,000/-: 08-12-2015
Pharmacological Group Fluoroquinolone antibacterial
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s: As per SRO
Approval status of product in Evoxil tablet by Beacon Pharmaceutical
Me-too status Lefoflox tablet by Bosch Pharma
GMP status GMP inspection report within 1 year is not available
Remarks of the EvaluatorIII. GMP inspection report within 1 year is not available
Decision of 284th meeting of RB  Registration Board deferred the case for further
deliberation.
Evaluation by PEC  Firm has submitted latest GMP inspection report
dated 25-10-2018 which specifies good compliance to
GMP.
 Decision:
Brand Name +Dosage Form + Setaxin Tablet 500mg
Strength
Levofloxacin as hemihydrate eq to levofloxacin…..500mg
PKR 20,000/-: 08-12-2015
Type of Form Form 5
Approval status of product in Evoxil tablet by Beacon Pharmaceutical
Me-too status Lefloxid tablet by Wnsfield Pharma
deliberation.
GMP.
 Decision:
Brand Name +Dosage Form + Egrol Sachet
Strength
Macrogol 3350………13.125g
Sodium Chloride…….0.3507g
Sodium Bicarbonate……..0.1785g
Potassium chloride………0.0466g
PKR 20,000/-: 08-12-2015
Pharmacological Group Osmotically active laxative
Type of Form Form 5
Pack size & Demanded Price 10’s: Rs. 225/-
14’s: Rs. 315/-
28’s: Rs. 630/-
Approval status of product in Movicol 13.8g sachet by Norgine Limited
Me-too status Movopeg Sachet by Wnsfeild Pharmaceutical,
Evidence of sachet section could not be confirmed
deliberation.
GMP.
 Evidence of sachet section could NOT be
confirmed
 Decision:
Brand Name +Dosage Form + Grash Capsule
Strength
Orlistat……….60mg
PKR 20,000/-: 04-12-2015
Pharmacological Group Antiobesity preparation
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 84’s: As per SRO
Approval status of product in Beacita Capsule by Actavis
Me-too status Orslim capsule by Pharmevo
Source of pellets including GMP of manufacturer, stability
study data of pellets is not provided.
deliberation.
GMP.
 Source of pellets including GMP of
manufacturer, stability study data of pellets is not provided.
 Decision:
Brand Name +Dosage Form + Grash Capsule
Strength
Orlistat……….120mg
PKR 20,000/-: 04-12-2015
Pharmacological Group Antiobesity preparation
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, 84’s: As per SRO
Approval status of product in Beacita Capsule by Actavis
Me-too status Orslim capsule by Pharmevo
Source of pellets including GMP of manufacturer, stability
study data of pellets is not provided.
deliberation.
GMP.
 Source of pellets including GMP of
manufacturer, stability study data of pellets is not provided.
 Decision:
527. Name and address of M/s Welmed Pharmaceutical Industries (Pvt) Ltd., Plot #
manufacturer / Applicant 108, R.2, Industrial Estate Gadoon, Swabi, KPK.
Brand Name +Dosage Form + Letpro 2.5mg Tablet
Strength
Composition Dy No. 15265: 24-4-2018
PKR 20,000/-: 23-4-2018
Diary No. Date of R& I & fee Each film coated tablet contains:
Letrozole…….2.5mg
Pharmacological Group Non-Steroidal aromatase inhibitor
Type of Form Form 5
Approval status of product in Femara Tablets by Novartis
Me-too status Femara Tablets by Novartis
GMP status Last GMP inspection dated 12-7-2018 concludes as “All the
observations were discussed with the firm management and
technical persons. They committed to rectify all the
observations. The firm may be considered to be operating in
satisfactory level of cGMP compliance subject to fulfillment of
observations mentioned in the inspection report”
Recommendations:
The firm should rectify all the observations in the report in the
shortest period of time and convey the same to QALT division.
Remarks of the EvaluatorIII.
Decision of 285th meeting of RB Registration Board referred the case to QA&LT division for
detailed evaluation of the GMP inspection report.
Evaluation by PEC  Firm has submitted Panel inspection report dated
12-12-2018 for verification of compliance of last routine
GMP inspection, the report concluded as “The firm has
rectified majority of observations noted in the previous
inspection and the management is committed to further
improve their GMP compliance. The firm may be
considered to be operating in satisfactory level of cGMP
compliance”.
 Decision:
528. Name and address of M/s Ahad Pharmaceuticals Ltd., 13 KM, Gomal
manufacturer / Applicant University, Multan Road, Dera Ismail Khan
Brand Name +Dosage Form + Anmycin Injection
Strength
Lincomycin as hydrochloride……..600mg
PKR 20,000/-: 08-12-2015
Pharmacological Group Lincosamide
Type of Form Form 5
Pack size & Demanded Price 2ml x 5’s ampoule packed in unit carton: As per SRO
Approval status of product in Lincocin injection by Pharmacia Upjohn
Me-too status Lincomycin Injection by Abbott Pharma
GMP status Could not be confirmed
Remarks of the EvaluatorIII.  GMP inspection within last 1 year is required
Decision of 284th meeting of RB Registration Board referred the case to QA & LT Division to
conduct GMP inspection of Firm on priority.
Evaluation by PEC  Firm has submitted GMP inspection report dated
07-11-2018 which concludes as “The firm may be
considered to be operating at satisfactory level of cGMP
compliance”
 Decision:
529. Name and address of M/s Welwrd Pharmaceuticals,
manufacturer / Applicant Plot No. 03, Block –A, Phase-I,II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Wrdrop 150mg tablet
Strength
Composition Duplicate copy where these particulars couldn’t be verified.
Diary No. Date of R& I & fee Each prolonged release Tablet contains: -
Bupropion hydrochloride …150mg
Type of Form Form-5
Approval status of product in Zyban 150 mg prolonged release tablets by M/s
Reference Regulatory Authorities. GlaxoSmithKline UK (MHRA approved)
Me-too status Wellbutrin XL Tablets 150mg by M/s Glaxosmithkline
(Reg#047527)
GMP status Last GMP inspection conducted on 14-06-2017 and the report
concludes that overall the firm is GMP compliant.
Remarks of the EvaluatorIII.  Diary No. Date of R& I & fee:
Duplicate copy where these particulars couldn’t be
verified.
Firm has submitted complete fee PKR 20,000 dated 28-6-
2018
Decision of 283rd meeting of RB Deferred for verification of submission of application on 16-
7-2014 in R&I DRAP.
Evaluation by PEC  Firm has submitted copy of receiving of their
application “WRDROP 150mg Tablet” in DRAP R&I on
16-7-2014.
 The application is also present in list-II at Sr. No
359.
 Decision:
530. Name and address of NOA HEMIS Pharmaceuticals, Plot No. 154, Sector 23,
manufacturer / Applicant Korangi Industrial Area Karachi
Brand Name +Dosage Form + Flexem 30mg Capsule
Strength
Cyclobenzaprine hydrochloride…..30mg
Diary No. Date of R& I & fee Dy. No. 190: 31-05-2010
PKR 8000/- (31-5-2010) +
PKR 12,000/- (13-5-2013)
Pharmacological Group (muscle relaxant)
Type of Form Form 5
Pack size & Demanded Price 7’s, 14’s, As per SRO
Approval status of product in Amrix Capsule by Teva (USFDA Approved)
Me-too status Emrix-SR 30mg Capsule by Getz Pharma
GMP status
Remarks of the EvaluatorIII. Reminder
17-5-2018
Letter
10-04-2018
 Latest GMP inspection report (which should
have been conducted within the period of last one year).
 Evidence of approval of manufacturing facility /
section of the manufacturer by Licensing division.
 Evidence of submission of 12,000/- fee chalan.
 Justify the formulation of cyclobenzaprine
hydrochloride plain (immediate release) capsule, since the
product approved by reference regulatory authorities and by
DRAP is cyclobenzaprine hydrochloride extended release
capsule.
 For cyclobenzaprine hydrochloride extended
release pellets, provide
o Source of pellets
o GMP of manufacturer of pellets
o Certificate of Analysis of Pellets
o Stability study data of 3 batches of pellets
o Differential fee (if pellets are imported).
Decision of 284th meeting of RB Registration Board deferred the case for further deliberation.
Evaluation by PEC Firm has submitted the following documents:
 Section approval letter for capsule section
 Copy of fee chalan of 12,000/- dated 08-05-2013
confirming good compliance to GMP
 Revised formulation as follows
Each capsule contains:
Cyclobenzaprine HCl (as extended release pellets)….30mg
Firm has not yet submitted source of pellets.
 Decision:
531. Name and address of M/s Lisko Pakistan (Pvt) Ltd., L-10-D, Block-21, Shaheed
manufacturer / Applicant Rashid Minhas Road F.B Industrial Area Karachi.
Brand Name +Dosage Form + Valsart Plus Tablet 10/160/25mg
Strength
PKR 20,000/-: 25-8-2017
Amlodipine as besylate………10mg
Valsartan……160mg
Hydrochlorthiazide………25mg
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s:
Approval status of product in Exforge HCT tablet by Novartis
Me-too status Exforge HCT tablet by Novartis
GMP status Last inspection report dated 24-4-2018 confirms satisfactory
compliance to GMP.
Decision of 283rd meeting of RB Registration Board deferred the case as FID has reported for
not having stability chamber for conducting Real time
stability studies.
Evaluation by PEC FID-V Karachi through its letter No. F.SAA.02-06/2018-FID-
V (K) dated 30th August 2018 has confirmed that firm has
purchased 2 stability chambers with capacity of 250 L
(accelerated) and 800L (Real time).
 Decision:
Brand Name +Dosage Form + Mypride 50mg Tablet
Strength
PKR 20,000/-: 25-8-2017
Itopride hydrochloride….......50mg
Pharmacological Group Antiemetic
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Pack size & Demanded Price 10’s, 30’s: As per SRO
Approval status of product in (PMDA approved)
Me-too status Ganaton 50 mg tablet by M/s Abbott.
compliance to GMP.
stability studies.
 Decision:
Brand Name +Dosage Form + Kufest Syrup
Strength
PKR 20,000/-: 25-8-2017
Carbocisteine………250mg
Pharmacological Group Mucolytic
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Pack size & Demanded Price 120ml Bottle: As per SRO
Approval status of product in Mucodyne Oral solution of M/s Sanofi Aventis
Me-too status Rhinathiol 5% for adults of M/s Sanofi Aventis
compliance to GMP.
stability studies.
 Decision:
534. Name and address of M/s. Bryon Pharmaceuticals, Peshawar
Brand Name +Dosage Form + Omeceph Oral Dry Suspension
Strength
Diary No. Date of R& I & fee 18-6-2010 : PKR 8,000 (18-6-2010) +
PKR 12,000/- (11-03-2013) (Photocopy)
Composition Each 5 ml contains:-
Cefixime trihydrate equivalent to Cefixime ………..100 mg
Pharmacological Group (Cephalosporin)
Type of Form Form 5
Pack size & Demanded Price 30 ml: Rs.284.0
Approval status of product in MHRA Approved
Me-too status Cefim suspension by Hilton
Decision of 238th meeting of RB Deferred till inspection by Licensing Section.
Evaluation by PEC Firm has submitted copy of section approval letter for dry
suspension (cephalosporin) and capsule (cephalosporin)
section dated 28-01-2019.
 Decision:
Brand Name +Dosage Form + Omeceph Oral DS Dry Suspension
Strength
PKR 12,000/- (11-03-2013) (Photocopy)
Composition Each 5 ml contains:-
Cefixime trihydrate equivalent to Cefixime ………..200 mg
Type of Form Form 5
Pack size & Demanded Price 30 ml: Rs.345.0
Me-too status Cefim suspension by Hilton
 Decision:
Brand Name +Dosage Form + Omeceph 400 mg Capsules
Strength
PKR 12,000/- (11-03-2013) (Photocopy)
Cefixime trihydrate ≡ Cefixime ………..400 mg
Type of Form Form 5
Pack size & Demanded Price 5’s : Rs.505
Me-too status Cefim capsule by Hilton
 Decision:
537. Name and address of M/s Delta Pharma Pvt Ltd.
manufacturer / Applicant Plot. No. 9, Nowshera Industrial Estate, Risalpur, Kpk,
Pakistan
Brand Name +Dosage Form + Ventodine 2mg/5ml Liquid Suspension
Strength
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 Ventolin Syrup by Glaxo Wellcome
Reference Regulatory Authorities. (MHRAb 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
 Decision:
Pakistan
Brand Name +Dosage Form + Zindell 20mg/5ml Liquid Suspension
Strength
Zinc as Sulphate Monohydrate…20mg
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
Approval status of product in WHO recommended formulation
Me-too status Zincat-OD Syrup by Atco Pharma
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.
formulation
Evaluation by PEC  Firm has revised formulation as per reference
Each 5ml of solution Contains:
Zinc as Sulphate Monohydrate…20mg
 Decision:
Pakistan
Brand Name +Dosage Form + Excip 250mg/5ml Dry Powder
Strength
Ciprofloxacin as Ciprofloxacin HCL…250mg
PKR 20,000/- : 04-12-2018
Type of Form Form-5
Approval status of product in Ciproxin 250mg/5ml granules and solvent for oral suspension
Reference Regulatory Authorities. by Bayer (MHRA Approved)
Me-too status Novidat Dry Powder for Suspension by Sami Pharma
dated 12-10-2018
Remarks of the Evaluator.  Justify the formulation containing ciprofloxacin
as hydrochloride since the reference formulation approved
by MHRA contains ciprofloxacin base.
 Provide source of granules of ciprofloxacin since
granulation process is not mentioned in method of
manufacturing.
formulation
Evaluation by PEC  Source of pellets: Vision Pharmaceuticals
 Firm has revised formulation as per reference
Each 5ml Contains:
Ciprofloxacin …250mg
 Decision:
Pakistan
Brand Name +Dosage Form + Excip 125mg/5ml Dry Powder
Strength
Ciprofloxacin as Ciprofloxacin HCL…125mg
PKR 20,000/- : 04-12-2018
Type of Form Form-5
Approval status of product in Approved by Registration Board based on quantitative
Reference Regulatory Authorities. composition mentioned in SmPC of 250mg dry suspension
Me-too status Nafcin 125mg Suspension by Global Pharma
dated 12-10-2018
Remarks of the Evaluator.  Justify the formulation containing ciprofloxacin
as hydrochloride since the reference formulation approved
by MHRA contains ciprofloxacin base.
 Provide source of granules of ciprofloxacin since
granulation process is not mentioned in method of
manufacturing.
formulation
Evaluation by PEC  Source of pellets: Vision Pharmaceuticals
 Firm has revised formulation as per reference
Each 5ml Contains:
 Decision:
541. Name and address of M/s Pharmedic Laboratories (Pvt) Ltd., 16-Km Multan
manufacturer / Applicant Road Lahore
Brand Name +Dosage Form + Prazem 0.25 Tablet
Strength
PKR 20,000/-: 22-07-2015
Alprazolam………….0.25mg
Pharmacological Group Benzodiazepines
Type of Form Form 5
Pack size & Demanded Price 30’s: Rs 136/30 tablets
Approval status of product in Xanax by Pfizer
Me-too status Xanax by Pfizer
compliance to GMP
Decision of 273rd meeting of RB Deferred for confirmation of approved manufacturing
facility/section by Central Licensing Board.
Evaluation by PEC Firm has submitted copy of approval of Tablet (psychotropic)
section dated 6th September 2018.
 Decision:
542. Name and address of M/s Pharmedic Laboratories (Pvt) Ltd., 16-Km Multan
manufacturer / Applicant Road Lahore
Brand Name +Dosage Form + Prazem 0.5mg Tablets
Strength
PKR 20,000/-: 22-07-2015
Alprazolam………….0.5mg
Pharmacological Group Benzodiazepines
Type of Form Form 5
Pack size & Demanded Price 30’s: Rs 191/30 tablets
Approval status of product in Xanax by Pfizer
Me-too status Xanax by Pfizer
compliance to GMP
Decision of 273rd meeting of RB Deferred for confirmation of approved manufacturing
facility/section by Central Licensing Board.
Evaluation by PEC Firm has submitted copy of approval of Tablet (psychotropic)
section dated 6th September 2018.
 Decision:
543. Name and address of M/s Care Pharmaceuticals, 8-km,Thokar, Raiwind
manufacturer / Applicant Road, Lahore.
Brand Name +Dosage Form + Optilone Eye Drops
Strength
Prednisolone.....0.1%w/w
Diary No. Date of R& I & fee Dy. No. 7447 dated 20-07-2012 Rs.8000 & Rs.12,000 dated
30-07-2013
Pharmacological Group Corticosteroid
Type of Form Form 5
Pack size & Demanded Price Rs.30/10ml pack.
Approval status of product in --
Me-too status Solopred drops by M/s Jeans
GMP status Firm is GMP compliant as per inspection by area FID.
Decision of 257th meeting of RB Deferred for the confirmation of approval status in
reference drug Authorities and manufacturing facility
Evaluation by PEC  Following reference submitted by firm has been
verified:
“Pred Mild ophthalmic drop by M/s Allergen
(approved by USFDA)”
 Firm has also submitted revised Form-5 with
following composition as per reference product:
“Each ml contains:-
Prednisolone as acetate.....0.1%w/w”
 Fee of Rs. 5,000 has also been submitted vide
deposit slip# 0792098 dated 06-02-2019 for revision
of formulation.
 Moreover firm has referred to 248th meeting
of Registration Board wherein Board has allowed
manufacturing of steroidal ophthalmic preparation
in general area.
 Decision:
Brand Name +Dosage Form + Occubetan Eye Drops
Strength
Neomycin as sulphate ….... 0.5%w/v
Betamethasone as Sodium Phosphate …. 0.1%w/v
Diary No. Date of R& I & fee Dy. No. 7444 dated 20-07-2012 Rs.8000 & Rs.12,000 dated
30-07-2013
Pharmacological Group Antibiotic/Corticosteroid
Type of Form Form 5
Finished Product Specification Manufacturer’s Specifications.
Pack size & Demanded Price Rs.50/7.5ml.
Me-too status Betatek-N Drops by M/s Innvotek Pharma
th
| 247
Decision of 257th meeting of RB Deferred for the confirmation of approval status in
reference of drug authorities
Evaluation by PEC  Following reference submitted by firm has been
verified:
“Betnesol-N Eye, Ear and Nose Drops by M/s RPH
Pharmaceuticals AB (approved by MHRA of
UK)”
Web link (accessed on 08-02-2019):
http://www.mhra.gov.uk/home/groups/spcpil/documents/spcp
il/con1542345155760.pdf
 Decision:
Brand Name +Dosage Form + Epitizo Syrup
Strength
Composition Each 5ml contains:-
Pizotifen (as Hydrogen Maleate) …………. 0.25mg
Diary No. Date of R& I & fee Dy. No. dated 01-06-10
Pharmacological Group Appetite Stimulant/ Vitamin
Type of Form Form 5
Finished Product Specification Manufacturer’s Specifications.
Pack size & Demanded Price Rs.50/60ml.
Me-too status Mosegor syrup by M/s Novartis Pharma
Decision of 257th meeting of RB Referred to the Review Committee
Evaluation by PEC Firm has submitted that applied formulation is approved
by MHRA of UK i.e., Sanomigran 0.25mg/5ml.
Moreover Registration Board in its recent meetings have
approved the same formulation
It is also submitted that previously pharmacological
group was mistakenly mentioned so please correct it as
Anti- Migraine according to international classification
of this drug.
 Decision:
Evaluator PEC-V
546. Name and Address of Manufacturer / M/s Pacific Pharmaceuticals Ltd, 30-km, Multan Road,
Applicant Lahore.
Brand Name + Dosage Form +
Oncamide/Oncomide Tablets 50mg
Strength
Diary No. Date of R & I & fee Diary No:12520, 05/04/2018, Rs. 20,000/-
Composition
Biclatumide… 50mg
Antineoplastic And Immunomodulating Agents
Pharmacological Group Anti-Androgens
ATC code L02BB03
Type of Form Form-5
Pack Size & Demanded Price 28’s/ As per SRO
Approval Status of Product in
COSUDEX bicalutamide 50mg tablet film coated by
Reference
AstraZeneca Pty Ltd (TGA Approved)
Me-too Status Casodex 50mg Tablet by ICI (Reg. No. 027380)
07-11-2017
GMP Status
Panel recommends grant of Additional sections
Deferred for clarification/justification for
Previous Decision(M-283): manufacturing of applied formulation in Tablet
(Hormone) section.
Fresh Evaluation:
Firm has submitted that said product is not a hormone and will be manufactured in General
Tablet Manufacturing Facility by taking the safety and protective measures.
The said product is used to treat prostate cancer and as per DRAP policy Anticancer products
will be given priority.
Decision:
547. Name and address of manufacturer
M/s Medipak limited 132/1,Industrial Estate, Kot Lakhpat,
/
Lahore
Applicant
Medisol BES
Brand Name +Dosage Form +
Balanced Electrolyte Solution
Strength
Opthalmic Irrigation Solution.
Diary No. Date of R& I & fee Diary No:19938, 3/11/2017, Rs: 20,000/- Dated 2/11/2017
Each 100 mL containing
sodium chloride …. 0.64g
potassium chloride ..0.075g
Composition calcium chloride dehydrate…0.048g
magnesium chloride hexahydrate 0.03g
sodium acetate trihydrate 0.39g
sodium citrate dehydrate…0.17g
Pharmacological Group Extraocular and intraocular irrigating solution
Type of Form Form 5
Finished product Specification Mfg.
Pack size & Demanded Price 500 ml LDPE, As per SRO
Approval status of product in BSS*
Reference Sterile Irrigating Solution (balanced salt solution)
025684
Me-too status Balanced Salt Solution 500ml
M/s Alza Pharmaceuticals, Islamabad
17-10-2017, Satisfactory. Management was keen to
GMP status
maintain and improve the compliance to highest level.
 Section is present.
Remarks of the Evaluator.  The international availability of the applied formulation
is in polypropylene container whereas, firm has applied for
LDPE container.
Deferred for the following reasons:
 Submission of evidence of applied formulation/drug
already approved by DRAP (generic / me-too status)
along with registration number, brand name and name
Previous Decision (M-285): of firm.
 Submission of evidence of applied formulation in
“LDPE container” as approved in reference regulatory
the Registration Board in its 275th meeting.
Fresh Evaluation:
Firm has submitted that their product is already registered in 10 ml and 250 ml pack size with
same formulation Registration No. 014778 and manufacturing since 1994. The only difference
is pack size.
To strengthen the case firm has provided the following:
I. Packaging Design Compatibility with salts and Blow Fill seal Technology.
II. Leachability factor
III. Physical and Chemical Factors
IV. SGS Testing Report
V. Shelf Life Stability Report of 250 ml pack size.
Decision:
548. Name and address of manufacturer M/s. Reign Pharmaceuticals, TBIC Building –I,
/ Applicant PCSIR Laboratories Complex,
Shahrah-E-Dr. Salim uz Zaman Siddiqui Road, Off
University Road, Karachi
Brand Name +Dosage Form + Lesil Tablet 250mg
Strength
Composition Each film coated contains:
Levofloxacin as hemihydrate……250mg
Diary No. Date of R& I & fee 161, 8-11-16, Rs. 20,000/-
Pharmacological Group Quinolone Anti-bacterial
Fluoroquinolones
ATC code J01MA12
Type of Form Form 5
Approval status of product in Levaquin by Janssen Ortho LLC
Me-too status Registration Number: 023979
Brand Name: Levoflox Tablets 250mg
Manufacturer Name: Bosch Pharmaceuticals (Pvt) Ltd,
221, Bosch House Sector 23, Korangi Industrial Area
Karachi
GMP status Last inspection report 08-11-2017 overall GMP
compliance level is rated as good.
Remarks of the Evaluator. ● Approved in USFDA with box warning.
● Overage has been added.
Firm provided the following justification
To adjust potency we add overage. We are applying wet
granulation method/Drying in which potency is reduced.
To adjust potency we add water content value.
Calculation
Strength of tablet factor x %LOD
Previous Decision (M-282) Deferred for clarification since the justification
submitted for use of overage is irrational.
Evaluation by PEC:
Firm has submitted that they will not use overage.
Decision:
549. Name and Address of Manufacturer / M/s Aulton Pharmaceuticals,
Applicant Plot#84/1, Block-A, Phase 5, Industrial Estate, Hattar.
Brand Name + Dosage Form + Tazo Tablet 2 mg
Strength
Diary No. Date of R & I & fee Diary No:19823 ,02/11/2017, Rs: 20,000/- , 01/11/2017
Tizanidine as HCl……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 of MHRA approved
Me-too Status Tandolax 2mg Tablet M/s High-Q Pharmaceuticals
GMP Status Inspection dated 13-02-2018
"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. Evidence of approval of applied formulation as “film
coated tablets” in reference regulatory
Previous Decision(M-285) Deferred for submission of evidence of approval of
applied formulation as “film coated tablets” in
declared/approved by the Registration Board in its
275th meeting.
Evaluation by PEC:
Firm has revised their formulation from film coated to uncoated tablets with submission of Rs.
5000/- dated 17-12-2018.
Decision:
550. Name and Address of Manufacturer / M/s Aulton Pharmaceuticals,
Applicant Plot#84/1, Block-A, Phase 5, Industrial Estate, Hattar.
Brand Name + Dosage Form + Tazo Tablet 4 mg
Strength
Diary No. Date of R & I & fee Diary No:19824 ,02/11/2017, Rs: 20,000/- , 01/11/2017
Tizanidine as HCl……4mg
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 of MHRA approved (uncoated)
Me-too Status Tandolax 4mg Tablet M/s High-Q Pharmaceuticals
GMP Status Inspection dated 13-02-2018
"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"
coated tablets” in reference regulatory
Previous Decision(M-285) Deferred for submission of evidence of approval of
applied formulation as “film coated tablets” in
275th meeting.
Evaluation by PEC:
Firm has revised their formulation from film coated to uncoated tablets with submission of Rs.
5000/- dated 17-12-2018.
Decision:
551. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-Km, Feroz
Applicant Pur Road, Lahore.
Brand Name +Dosage Form + Strength Micin Gel 1%
Composition Each g of gel contains:
Clindamycin as phosphate……1%
Diary No. Date of R& I & fee Duplicate, 22-12-2010, 8,000/-, (Photocopy attached), 22-
12-2010, 12,000/- (Photocopy attached), 31-03-2015
Pharmacological Group Anti-infectives for treatment of acne
ATC Code; D10AF01
Type of Form Form 5
Pack size & Demanded Price 15g, 20g
Approval status of product in Approved by USFDA
Me-too status Uniclin Gel by M/s Kaizen Pharma, Karachi (Reg.
No. 076304)
GMP status Inspection dated 30-08-2017 recommended for Renewal
of DML.
Remarks of the Evaluator. Duplicate Dossier.
Previous Decision(M-285):
Deferred for submission of latest GMP inspection report which should have been conducted
within the period of last one year.
Fresh Evaluation:
Date of inspection: 07-06-2017, 30-08-2017. Recommendation of DML.
Decision:
Brand Name +Dosage Form + Strength Isonon Plus Gel
Erythromycin…20mg
Isotretinoin…..0.5mg
Pharmacological Group Anti-acne preparations
ATC Code: D10AD54
Type of Form Form 5
Pack size & Demanded Price 10g
Approval status of product in Isotrexin® Gel (MHRA Approved)
Me-too status Tretocin by Derma tecno Pakistan
of DML.
Fresh Evaluation:
Date of inspection: 07-06-2017, 30-08-2017. Recommendation of Renewal DML.
Decision:
Brand Name +Dosage Form + Strength Tacrus Ointment 0.03%
Tacrolimus (as monohydrate)…0.3mg (0.03%w/w)
Pharmacological Group Agents for dermatitis, excluding corticosteroid
ATC Code: D11AH01
Type of Form Form 5
Approval status of product in PROTOPIC (tacrolimus) Ointment 0.03%w/w by M/s
Reference Regulatory Authorities. LEO PHARMA AS (USFDA Approved)
Me-too status Tacroderm Ointment 0.03% by M/s Caraway
of DML.
Fresh Evaluation:
Decision:
Brand Name +Dosage Form + Strength Myfate DS Tablet
Sucralfate…1g
Pharmacological Group Anti-ulcer
ATC Code: A02BX02
Type of Form Form 5
Approval status of product in USFDA Approved (Uncoated)
Me-too status Registration Number:011748
Brand Name: SUCFATE 1GM TAB Each tablet
contains:- SUCRALFATE 1000mg
Manufacturer Name:SIZA
of DML.
Remarks of the Evaluator. Firm has revised their formulation from film coated to
uncoated tablet without submission of fee.
Fresh Evaluation:
Decision:
Brand Name +Dosage Form + Strength Tenovir Tablet 300mg
Tenofovir Disoproxil fumarate………300mg
12-2009,
Pharmacological Group Nucleoside reverse transcriptase inhibitors
ATC Code: J05AF07
Type of Form Form 5
Finished product Specification Mfg. Specs
Pack size & Demanded Price 30’s in PVC jar
Approval status of product in Tenofovir by Teva Pharma
Me-too status Tenofo-B by Getz
of DML.
Previous remarks of the Evaluator. Approved with box warning in USFDA.
Fresh Evaluation:
Decision:
556. Name and address of Manufacturer / M/s Shaheen Pharmaceuticals.
Applicant 3 km, Murghzar Road,Saidu Sharif, Swat
Brand Name+DosageForm+Strength Dipam Tablet 5mg
Diazepam…5mg
Diary No. Date of R&I & fee Dy No.30435; 10-09-2018; Rs.20,000/-
Pharmacological Group Anxiolytics
Benzodiazepine derivative
ATC Code: N05BA01
Type of Form Form 5
Pack Size & Demanded Price 3x10’s, As per PRC
Dipam tablet
By Leads Pharma Pvt Ltd,
GMP status The Central Licensing Board in its 265th meeting held on
09th -10th August, 2018 has considered and approved the
grant of following one (01) additional section
1. Psychotropic Tablet Section in place of
Quinolone Tablet section and shifting of Quinolone tablet
section to tablet General Section.
Remarks of Evaluator Approved in USFDA with box warning.
Firm has revised their formulation from film coated to
uncoated tablet without the submission of fee.
Previous Decision (M-286):
Deferred for submission of fee of Rs. 5000/- as the formulation has been revised from film
coated to uncoated tablets.
Fresh Evaluation:
Firm has submitted fee of Rs. 5000/- dated 27-12-2018.
Decision:
Applicant 3 km, Murghzar Road,Saidu Sharif
Diazepam…2mg
ATC Code: N05BA01
Type of Form Form 5
Anxosal 2mg Tablets
By Universal Pharmaceuticals (Pvt) Ltd.
Fresh Evaluation:
Decision:
558. Name and address of Manufacturer / M/s Shaheen Pharmaceuticals.3 km, Murghzar
Applicant Road,Saidu Sharif
Diazepam…10mg
ATC Code: N05BA01
Type of Form Form 5
Dipam tablet
By Leads Pharma Pvt Ltd,
Fresh Evaluation:
Brand Name+DosageForm+Strength Zepam Tablet 6mg
Bromazepam…6mg
ATC Code: N05BA08
Type of Form Form 5
Finished Product Specification Inhouse
Approval status of product in Reference TGA Approved (uncoated)
"Normeez 6mg Tablets
By Navegal Laboratories
Remarks of Evaluator Firm has revised their formulation from film coated to
Fresh Evaluation:
Brand Name+DosageForm+Strength Zepam Tablet 1.5 mg
Bromazepam…1.5 mg
ATC Code: N05BA08
Type of Form Form 5
Finished Product Specification In-house
Pack Size & Demanded Price 3x10’s, As per SRO.
Yazd 1.5mg Tablet
By M/s. Wilshire Laboratories (Pvt) Ltd;
 Submission of fee of Rs. 5000/- as the formulation has been revised from film coated to
uncoated tablets.
 Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board in its
275th meeting.
Fresh Evaluation:
Swissmedica Approved.
Brand Name+DosageForm+Strength Zepam Tablet 3mg
Bromazepam…3mg
ATC Code: N05BA08
Type of Form Form 5
Approval status of product in Reference TGA Approved
"Normeez 6mg Tablets
By Navegal Laboratories
Fresh Evaluation:
Brand Name+DosageForm+Strength Nazep Tablet 0.5mg
Composition Each tablet contains::
Clonazepam…0.5mg
Pharmacological Group Antiepileptics
Benzodiazepine derivatives
ATC Code: N03AE01
Type of Form Form 5
"Clonazil Tablet 0.5mg
By "M/s English Pharm,
Fresh Evaluation:
563. Name and address of Manufacturer / M/s Shaheen Pharmaceuticals. 3 km, Murghzar
Brand Name+DosageForm+Strength Nazep Tablet 1mg
Clonazepam…1mg
ATC Code: N03AE01
Type of Form Form 5
"Curo 1mg Tablets
"M/s. Wilshire Laboratories (Pvt) Ltd;
Fresh Evaluation:
Brand Name+DosageForm+Strength Nazep Tablet 2mg
Clonazepam…2mg
ATC Code: N03AE01
Type of Form Form 5
"Clonazil Tablet 2mg
By "M/s English Pharm,
Fresh Evaluation:
Brand Name+DosageForm+Strength Butone Tablet 30mg
Phenobarbitone…30mg
Barbiturates and derivatives
ATC Code: N03AA02
Type of Form Form 5
Approval status of product in Reference MHRA Approved (uncoated)
"Phenotone Tablets
by "M/s Rasco Pharma,
Fresh Evaluation:
Brand Name+DosageForm+Strength Alpraz Tablet 2mg
Alprazolam…2mg
ATC Code: N05BA12
Type of Form Form 5
Approval status of product in Reference USFDA Approved (uncoated)
Lydia 2mg Tablets
by M/s. Wilshire Laboratories (Pvt) Ltd;
Fresh Evaluation:
Brand Name+DosageForm+Strength Alpraz Tablet 1mg
Alprazolam…1mg
ATC Code: N05BA12
Type of Form Form 5
Lydia 1mg Tablets
Fresh Evaluation:
Applicant 3 km, Murghzar Road,Saidu Sharif
Brand Name+DosageForm+Strength Alpraz Tablet 0.25mg
Alprazolam…0.25mg
ATC Code: N05BA12
Type of Form Form 5
Lydia 0.25mg Tablets
Fresh Evaluation:
Brand Name+DosageForm+Strength Alpraz Tablet 0.5mg
Alprazolam…0.5mg
ATC Code: N05BA12
Type of Form Form 5
Lydia 0.25mg Tablets
Fresh Evaluation:
570. Name and address of manufacturer / M/s. Fynk Pharmaceuticals, 19-Km, Ferozepur Road,
Applicant G.T. Road, Kala shah Kaku, Lahore.
Brand Name +Dosage Form + Strength Neblol tablet 10mg
Nebivolol HCl equivalent to Nebivolol … 10mg
Diary No. Date of R& I & fee Dy. No. 17526, 09-10-2017; Rs.20,000/- (09-10-
2017)
ATC Code: C07AB12
Type of Form Form 5
Pack size & Demanded Price 1x14’s
Alu-Alu Blister
Brand Name:Nebil 10mg Tablet
Manufacturer Name:Getz
“Overall hygienic condition of firm is satisfactory and
they advised to comply all advises/shortcomings
which are mentioned above. They showed good
intension to improve further. However overall
condition of the firm is satisfactory.”
Remarks of the Evaluator. 1. The master formulation of the applied
AD PEC V formulation does not mention the coating
material.
2. Evidence of approval of applied formulation as
“film coated tablets” in reference regulatory
authorities/agencies which were
declared/approved by the Registration Board in
its 275th meeting.
 Submission of latest GMP inspection report which should have been conducted within
 Submission of the master formulation of the applied formulation mentioning the
coating material.
 Submission of evidence of approval of applied formulation as “film coated tablets” in
reference regulatory authorities/agencies which were declared/approved by the
Fresh Evaluation:
I. Firm has submitted that in 286th RB Meeting the GMP inspection conducted of any firm
shall be considered valid for a period of 3 years. Hence, GMP inspection conducted in Sep
2017 should be considered as valid.
20-09-2017 Conclusion:“Overall hygienic condition of firm is satisfactory and they advised to
comply all advises/shortcomings which are mentioned above. They showed good intension to
improve further. However overall condition of the firm is satisfactory.”
II. Revision of formulation from film coated to uncoated tablets and submission of Rs. 5000/-
dated 27-12-2018.
Brand Name +Dosage Form + Strength Neblol tablet 5mg
Nebivolol HCl equivalent to Nebivolol … 5mg
2017)
ATC Code: C07AB12
Type of Form Form 5
Alu-Alu Blister
AD PEC V coated tablets” in reference regulatory
the Registration Board in its 275th meeting.
Fresh Evaluation:
dated 27-12-2018.
Brand Name +Dosage Form + Strength Neblol tablet 2.5mg
Nebivolol HCl equivalent to Nebivolol … 2.5mg
2017)
ATC Code: C07AB12
Type of Form Form 5
Alu-Alu Blister
Remarks of the Evaluator.  Evidence of approval of applied formulation as
AD PEC V “film coated tablets” in reference regulatory
its 275th meeting.
Fresh Evaluation:
dated 27-12-2018.
Brand Name +Dosage Form + Strength Vildamin Tablets 50/850
Vildagliptin………50mg
2017)
Type of Form Form-5
Pack size & Demanded Price 1*14’s / As per SRO
Approval status of product in Reference GALVUMET 50mg/ 850mg film-coated tablet by M/s
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Limited
Me-too status Galvus Met 50/850mg Tablets by M/s Novartis
(Reg#066106)
they advised to comply all advises/shortcomings which
are mentioned above. They showed good intension to
improve further. However overall condition of the firm
is satisfactory.”
AD PEC V
Fresh Evaluation
20-09-2017 Conclusion: “Overall hygienic condition of firm is satisfactory and they advised to
Brand Name +Dosage Form + Strength Zolic Tablets 600mg
Linezolid ...................................600mg
2017)
Pharmacological Group Antibacterial
ATC Code: J01XX08
Type of Form Form-5
Pack size & Demanded Price 1x10;s, 12’s ,As per SRO
Me-too status Ecasil tablet of M/s Sami Pharmaceuticals
(Reg. # 066904)
AD PEC V
Fresh Evaluation
575. Name and address of manufacturer / M/s Fynk Pharmaceuticals, 19 Km G.T. Road,
Applicant Kalashah Kaku, Lahore.
E-Prazole Insta oral sachet
Brand Name +Dosage Form + Strength
Source of granules: Vision pharmaceuticals
Each sachet contains:

Composition Esomeprazole (as magnesium trihydrate EC 22.5%
granules)……….…………20mg
Type of Form Form-5
Pack size & Demanded Price 1x14’s; As per PRC
USFDA approved
Me-too status Somezol 20mg sachet of M/s Bosch Karachi
Copy of GMP inspection on 20-09-2017 concluded
GMP status
that overall condition of the firm is satisfactory.
● Firm has submitted the following scientific
justification of addition of 5% excess of API: “Stability
data of three batches of API has been provided for real
Remarks of the Evaluator. time and accelerated, that shows that the potency of the
API is reduced with the passage of time. So, 5% API of
the labelled amount is justified with the assay limit
90% to 110% for the labelled amount.”
Registration Board in its 282nd meeting did not

accede with firm’s justification for overage and
Previous Decision: deferred the case for submission of master formulation
without overage or with complete product development
data to justify overages.
 Firm has submitted revised master formulation

Evaluation by PEC:
without overage.
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
Fresh Evaluation
576. Name and address of manufacturer / M/s Fynk Pharmaceuticals, 19 Km G.T. Road,
Applicant Kalashah Kaku, Lahore.
E-Prazole Plus oral sachet
Brand Name +Dosage Form + Strength
Source of granules:Vision pharmaceuticals
Composition Esomeprazole (as magnesium trihydrate EC 22.5%
granules) ………………………40mg
Type of Form Form-5
Pack size & Demanded Price 1x14’s; As per PRC
USFDA approved
Me-too status Somezol 40mg sachet of M/s Bosch Karachi
Copy of GMP inspection on 20-09-2017 concluded that
GMP status
overall condition of the firm is satisfactory.
● Firm has submitted the following scientific
justification of addition of 5% excess of API: “Stability
data of three batches of API has been provided for real
Remarks of the Evaluator. time and accelerated, that shows that the potency of the
API is reduced with the passage of time. So, 5% API of
the labelled amount is justified with the assay limit
90% to 110% for the labelled amount.”
Registration Board in its 282nd meeting did not accede
with firm’s justification for overage and deferred the
Previous Decision:
case for submission of master formulation without
overage or with complete product development data to
justify overages.
 Firm has submitted revised master formulation
Evaluation by PEC:
without overage.
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
Fresh Evaluation
577. M/s. Lisko Pakistan (PVT.) LTD.L-10-D, Block No.21,
Name and address of manufacturer /
Shaheed Rashid Minhas Road, Federal “B” Industrial
Applicant
Area, Karachi
Brand Name +Dosage Form + Strength Legend Plus Capsule 40mg+1100mg
Composition Omeprazole……………………… 40mg
Sodium Bicarbonate……………1100mg
Drugs For Peptic Ulcer And Gastro-Oesophageal
Reflux Disease (Gord)
Pharmacological Group
Proton pump inhibitors/Antacid
ATC code: A02BC01
Type of Form Form-5
USFDA Approved
Registration Number: 070571
Me-too status Brand Name: Zoltar Insta 40mg Capsule
Manufacturer Name: Pharmevo
Latest GMP inspection conducted on 24-04-2018 and
the report concludes satisfactory level of GMP
GMP status
compliance.
(Recommendations)
Previously, applied formulation contained omeprazole
enteric coated pellets. Now the firm has replied
Omeprazole has been mistakenly taken as enteric
coated pellets and is in the form of powder.
Previous Decision (M-283): Deferred for the following reasons:
 Submission of Fee Rs.20,000/- for revision of formulation from enteric coated pellets of
omeprazole to powder.
 Un-availability of stability chamber for conducting real time stability analysis as per
observations mentioned in inspection report of area FID.
Fresh Evaluation:
I. Firm has submitted Fee Rs.5,000/- and 15,000/- dated 11-02-2019.
II. FID verified 2 stability chamber 1 for Accelerated stability studies and 1 for Real time
stability studies.
578. M/s. Lisko Pakistan (PVT.) Ltd.L-10-D, Block No.21,
Name and address of manufacturer /
Shaheed Rashid Minhas Road, Federal “B” Industrial
Applicant
Area, Karachi
Brand Name +Dosage Form + Strength Legend Plus Capsule 20mg+1100mg
Composition Omeprazole……………………… 20mg
Sodium Bicarbonate……………1100mg
Drugs For Peptic Ulcer And Gastro-Oesophageal
Reflux Disease (Gord)
Pharmacological Group
Proton pump inhibitors/Antacid
ATC code: A02BC01
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 15’s, 7’s, 30’s
USFDA Approved
Registration Number: 070570
Me-too status Brand Name: Zoltar Insta 20mg Capsule
Manufacturer Name: Pharmevo
Latest GMP inspection conducted on 24-04-2018 and
GMP status the report concludes satisfactory level of GMP
compliance.(Recommendations)
Previously, applied formulation contained omeprazole
enteric coated pellets. Now the firm has replied
Omeprazole has been mistakenly taken as enteric
coated pellets and is in the form of powder.
Previous Decision (M-283): Deferred for the following reasons:
 Submission of Fee Rs.20, 000/- for revision of formulation from enteric coated pellets of
omeprazole to powder.
 Un-availability of stability chamber for conducting real time stability analysis as per
observations mentioned in inspection report of area FID.
Fresh Evaluation:
I. Firm has submitted Fee Rs.5,000/- and 15,000/- dated 11-02-2019.
II. FID verified 2 stability chamber 1 for Accelerated stability studies and 1 for Real time
stability studies.
Evaluator PEC-IV
579. Name and address of manufacturer M/s. FAAS Pharmaceuticals (Pvt) Ltd . Plot No.
/ Applicant F/748-L., S.I.T.E., Karachi, Pakistan
Contract manufactured by
M/S Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi ,
Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Ulciloc 40mg IV Injection
Strength
Omeprazole Sodium (U.S.P) equivalent to Omeprazole
(Lyophilized powder)……….40mg
Diary No. Date of R& I & fee Dy.No. 17779; 14-05-2018; Duplicate dossier
Rs.50,000/- (18-08-2017)
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Approval status of product in Omeprazol 40mg injection of (MHRA approved)
Me-too status (with strength and Fymezole Dry Powder Injection IV of M/s Fynk
GMP status Routine GMP inspection of FAAS Pharmaceuticals
conducted on 14-07-2017 concluded that the current level
of compliance is rated satisfactory .
&
Last GMP of Nabi qasim Inspection conducted on 03-
08-2018 and report concludes that firm is considered to
be operating at an acceptable level of compliance of
GMP requirments.
Previous remarks of the Evaluator.  Contract manufacturing agreement: attached
 Number of sections of applicant approved by
Licensing Board:03
 Number of products already registered/approved on
contract manufacturing in the name of applicant: Nil
Previous decision(s) Deferred for following reasons:
Deferred for clarification of applied dosage form whether
lyophiloized powder or lyophilized cake. (M-285)
Evaluation by PEC Omeprazole sodium equivalent to omeprazole in the form
of Lyophilizes cake.
Decision:
580. Name and address of manufacturer M/S Welmed Pharmaceuticals Industries (Pvt) Ltd.,
/ Applicant 108, R:2 Industrial Estat,Gadoon, District Swabi,
Pakistan
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 + Welrose 20mg injection
Strength
Iron (as Sucrose)……….5mg
(Eq to 200,000 IU of vitamin D)
Pharmacological Group Anti anaemics
Type of Form Form 5
Pack size & Demanded Price 5ml x 5’s ; As per SRO
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
 Number of products already registered/approved
on contract manufacturing in the name of
applicant: 12
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.
Decision:
Pakistan

Brand Name +Dosage Form + Welferol 5mg injection
Strength
Cholecalciferol (Vitamin D3) ……….5mg
(Eq to 200,000 IU of vitamin D)
Pharmacological Group Vitamin D analogue
Type of Form Form 5
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)
&
Licensing Board :06
applicant: 12
Winthrox.
Decision:
Pakistan

highway, phase-II Karachi, Pakistan.
Brand Name +Dosage Form + Mecowel 500mcg injection
Strength
Mecobalamine…..500mcg
Pharmacological Group Co-enzyme-type vitamin B12
Type of Form Form 5
Approval status of product in PMDA approved
Me-too status (with strength and Wycomin 500 mcg Injection by Wnsfeild
dosage form) Pharmaceutical,
&
Licensing Board :06
applicant: 12
Winthrox.
Decision:
Pakistan

Brand Name +Dosage Form + Ketrol-T 30mg injection
Strength
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)
&
Licensing Board :06
applicant: 12
Winthrox.
Decision:
584. Name and address of manufacturer M/s Helix Pharma Karachi
/ Applicant
Brand Name +Dosage Form + Cymanta Capsule 20mg
Strength
22.4 mg of Duloxetine……20mg
Diary No. Date of R& I & fee Dy.No.995; 30-12-2014; Rs.12,000/- Duplicate dossier
Pharmacological Group Serotonin and Noradrenalin reuptake inhibitors
Type of Form Form 5
Finished product Specifications (USP Specs)
Pack size & Demanded Price 10’s & 14’s As per PRC
Approval status of product in Cymbalta of (USFDA approved))
Me-too status (with strength and Swenta 20mg Capsule by M/s Martin Dow
dosage form)
GMP status Last inspection conducted on 10-08-2017 and report
concludes that firm is found at satisfactory level of GMP
compliance
Previous remarks of the Evaluator.  Source of pellets: M/s Pelltech Healthcare India
 Rs; 1,00,000 fee challan attached (15-11-2017)
 Copy Of GMP certificate No: NEW-WHO-
Deferred for clarification of composition of applied
formulation. (M-285)
Evaluation by PEC Each capsule contains:
22.4mg of Duloxetine HCl (Enteric coated pellets)
equivalent to Duloxetine…………….20mg
Decision:
Evaluator-PEC-VI
585. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd,
Applicant 30-km, Multan Road, Lahore.
Brand Name +Dosage Form + Strength Femme-Safe Tablets 1.5mg
Levonorgestrel … 1.5mg
Diary No. Date of R& I & fee Diary No:10935, 26/03/2018, Rs. 20,000/-
Pharmacological Group Hormonal contraceptives for systemic use (Progestogens)
Type of Form Form-5
Approval status of product in Levonorgestrel 1.5 mg tablet by M/s Gedeon Richter Plc.
Remarks of the Evaluator. Me-too Status not confirmed from available
database.
Levonorgestrel: (Synthetic Progestogen) is a synthetic
estrane steroid and a derivative of testosterone
G GENITO URINARY SYSTEM AND SEX
HORMONES
G03 SEX HORMONES AND MODULATORS OF THE
GENITAL SYSTEM
G03A HORMONAL CONTRACEPTIVES FOR
SYSTEMIC USE
G03AC Progestogens
ATC Code : G03AC03
Previous Decision: Decision of 281st meeting:
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.
Decision of 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: Firm has provided me too as Emkit-DS tablet 1.5mg

of Zafa Pharma Reg # 032543.
Decision:
Brand Name +Dosage Form + Strength Fina-Grow 1mg Tablets
Finasteride…25mg
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form-5
Approval status of product in Finasteride 1 mg Film-coated Tablets by M/s TEVA UK

Reference Regulatory Authorities. Ltd (MHRA Approved)
Me-too status Hairfin Tablets 1mg by M/s Elko Organization
(Reg#034771)
Remarks of the Evaluator. Finasteride is a 5α-reductase inhibitor, and hence is an
antiandrogen.
Finasteride is a synthetic 4-azasteroid.
G GENITO URINARY SYSTEM AND SEX
HORMONES
G04 UROLOGICALS G04C DRUGS USED IN
BENIGN PROSTATIC HYPERTROPHY
G04CB Testosterone-5-alpha reductase inhibitors
ATC Code: G04CB01
Decision of 286th meeting:
Clarification required whether the applied product is
steroidal hormone or otherwise.
Evaluation by PEC: Firm has stated that applied formulation is a synthetic
4-azasteroid compound and is analogue of androgen
steroid hormone.
Decision:
Brand Name +Dosage Form + Strength Androstat Tablets 50mg
Cyproterone acetate … 50mg
Pharmacological Group Antiandrogen
Type of Form Form-5
Approval status of product in Androcur 50 mg tablets by M/s Bayer plc (MHRA

Reference Regulatory Authorities. Approved)
Me-too status Androcur 50 mg tablets by M/s ALI GOHAR & CO
(Reg#010221)
Remarks of the Evaluator. Cyproterone acetate: A synthetic steroidal antiandrogen.
CPA, also known as 1α,2α-methylene-6-chloro-17α-
acetoxy-δ6-progesterone or as 1α,2α-methylene-6-chloro-
17α-hydroxypregna-4,6-diene-3,20-dione acetate, is a
synthetic pregnane steroid and an acetylated derivative of
17α-hydroxyprogesterone
Deferred for further deliberation upon requirements of
manufacturing facility for applied formulation.
Evaluation by PEC: The firm has stated the the applied formultaions are
steroidal hormone and will be manufactured in
steroidal hormone section.
Decision:
Brand Name +Dosage Form + Strength Allure Tablets 0.035/2mg
Cyproterone acetate … 2mg
Ethinylestradiol… 0.035mg
Pharmacological Group Antiandrogens and estrogens
Type of Form Form-5
Approval status of product in Acnocin 2000/35 Tablets by M/s Sandoz Limited (MHRA
Reference Regulatory Authorities. Approved)
Me-too status DIANE-35 Tablets by M/s Ali Gohar & Co.
(Reg#011467)
Remarks of the Evaluator. Cyproterone acetate: A synthetic steroidal antiandrogen.
Ethinylestradiol: A Steroidal Sex hormone
Deferred for further deliberation upon requirements of
manufacturing facility for applied formulation.
Evaluation by PEC: The firm has stated the the applied formulations are
steroidal hormone and will be manufactured in
steroidal hormone section.
Decision:
589. 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
Pack size & Demanded Price As per SRO, As per SRO
Approval status of product in AFINITOR DISPERZ TABLET FOR ORAL

Reference Regulatory Authorities. SUSPENSION. USFDA Approved
GMP status Panel Inspection on 14-01-2017, No observations as
informed by QA.
Remarks of the Evaluator. Me-too status could not be confirmed.
Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
Evaluation by PEC: The firm has stated the Afinitor 3mg Dispersible
tablet (Everolimus…….3mg) has been approved in
M.263.
Decision:
590. Name and address of manufacturer / M/s Genome Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Everogen 2mg Dispersible tablets
Everolimus……2mg
Pharmacological Group Anti-neoplastic agent
Type of Form Form-5
Finished product Specification Manufacturer‘s Specification
Pack size & Demanded Price As per SRO, As per SRO
Approval status of product in AFINITOR DISPERZ TABLET FOR ORAL

Reference Regulatory Authorities. SUSPENSION. USFDA Approved
GMP status Panel Inspection on 14-01-2017, No observations as
informed by QA.
Remarks of the Evaluator. Me-too status could not be confirmed.
Deferred for evidence of applied formulation/drug already
Evaluation by PEC: The firm has stated the Afinitor 2mg Dispersible
tablet (Everolimus…….2mg) has been approved in
M.262.
Decision:
Evaluator PEC-VII
591. Name and address of manufacturer / M/s. News Pharma,42 Sunder industrial
Applicant estate, Raiwind road, Lahore
Brand Name +Dosage Form + Strength Newcocin 600mg/2ml Injection
Diary No. Date of R& I & fee Dy.No. 762, 30-3-2015, Rs.20,000/-
Lincomycin as HCl…..600mg
Pharmacological Group H-1-Antagonist
Type of Form Form-5
Pack Size & Demanded Price Rs.450.00/5x2ml ampoules (IM/IV)
Approval Status of Product in Reference Lincocin by Pharmacia (USFDA)
Me-too Status Lincococin by Pfizer
GMP status Last GMP Inspection of News Pharma
Conducted on 26-4-2018. GMP certificate is
provided
Remarks of the Evaluator. inspection report is not within the past one year
Decision of 273:
Deferred for latest GMP inspection report conducted within past one year.
Remarks of evaluator VII:
Last GMP Inspection of News Pharma Conducted on 26-4-2018. GMP certificate is provided
Decision:
592. Name and address of manufacturer / M/s. News Pharma,42 Sunder industrial
Applicant estate, Raiwind road, Lahore
Brand Name +Dosage Form + Strength Newcin Injection 80mg/2ml
Diary No. Date of R& I & fee Dy.No. 762, 30-3-2015, Rs.20,000/-
Gentamicin (as sulphate)…….80mg
Water for injection q.s to….2ml
Pharmacological Group H-1-Antagonist
Type of Form Form-5
Pack Size & Demanded Price Rs.250.00/5x2ml ampoules
Rs.1125.00/25x2ml ampoules
Approval Status of Product in Reference Garamycin by Schering (USFDA)
Me-too Status Cidomycin by Sanofi aventis
GMP status Last GMP Inspection of News Pharma
Conducted on
6-4-2016 with conclusive remarks of cGMP
Compliance.
Remarks of the Evaluator. Inspection report is not within the past one year
Decision of 273:
Deferred for latest GMP inspection report conducted within past one year.
Last GMP Inspection of News Pharma Conducted on 26-4-2018. GMP certificate is provided
Decision:
593. Name and address of Manufacturer / M/s Winlet Pharma 30 Km, Laksian Lahore
Applicant road. Sargodha
Brand Name+ Dosage Form+ Strength Lorades 0.5 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
Me-too status Deltafast of Schaazoo
GMP status New DML granted Inspection Date 05/12/2017
Decision of 282:
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.
Each 5 ml contains:
Desloratadine …2.5 mg
International: (Clarinex syrup by Schering, USFDA Approved)
Me-too status: (Neo-antial syrup by Sami Pharma)
Fee of 5000/-, challan # 0814955, dated: 31/12/2018 was submitted
Decision:
Brand Name+ Dosage Form+ Strength Famole 10 mg/5ml susp
Famotidine ..........10 mg
Type of Form Form-5
Me-too status Apsin of saffron
Remarks of 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)
Decision of 282:
Each 5 ml contains:
Famotidine ..........40 mg
International: (Pepcid 40 mg/5 ml of Salix Pharma Inc., USA (USFDA)
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
Decision:
Brand Name+ Dosage Form+ Strength Fosfo 250 mg/5 ml DS
Composition Each 5ml(when reconstituted)contains:
Fosfomycin …250 mg
Pharmacological Group Antibiotic / antibacterial
Type of Form Form-5
Finished Product Specification Innovators
Me-too status Fosomin by CCL
Remarks of Evaluator Dry powder suspension is not available in any
reference authority
Decision of 282:
International: FOSFOCINA Suspension 250mg/5ml by Spain
Me-too status: Fosfonex 250mg/5ml Suspension of M/s Nexus Pharma
Decision:
Brand Name+ Dosage Form+ Strength Paradol Elixir 160 mg/ 5ml drops
Paracetamol…………………..160 mg
Pharmacological Group Iron Supplement/Hematinic
Type of Form Form-5
Me-too status NA
Remarks of Evaluator • Evidence of approval of applied
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 of 282:
Provided reference of health Canada “acetaminophen 160 child elixir” can’t be confirmed
Decision:
597. Name and address of manufacturer / M/s Cibex Pvt. Ltd. Factory # 405, SITE,
Applicant Karachi.
Brand Name +Dosage Form + Strength Balin chewable tablet
Composition Each chewable tablets contains:-
Mecobalamin……… 500 mcg
Diary No. Date of R& I & fee Dy. No. 224; 3-1-2017; Rs. 20,000/-
Pharmacological Group Co-enzyme Vit B12
Type of Form Form-5
Finished product Specifications Innovator specs
As per SRO
Approval status of product in Reference NA (Approved in PMDA as sugar coated)
Me-too status Mecomed 500mcg by Global Pharma (Reg. No.
041670) in sugar coating
GMP status Last GMP Inspection of Cibex Pvt. Ltd
conducted on 29-8-17 with conclusive remarks
of satisfactory level of cGMP compliance.
Decision of 282:
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting
and me too reference.
Provided reference of health Canada “Natural life nutrition product: natural one vitamin B-12.
Reg#: 80035585” can’t be confirmed
Me too: Himont pharma, hicobal chewable tablet, Reg # 032320 can’t be confirmed.
Decision:
598. Name and address of manufacturer / M/s Elite Pharma Pvt Ltd., P.D.H. Street 9.5
Applicant km Sheikhupura Road, Lahore.
Brand Name +Dosage Form + Strength Betavel ointment 5 gm Tube
Composition Each 5 gm ointment Contains:
Betamethasone as valerate………..0.1%
Diary No. Date of R& I & fee Dy.No. 11922, 15-8-2017, Rs.20,000/=
Pharmacological Group Corticosteroids
Type of Form Form-5
Pack size & Demanded Price 5 gm
As per SRO
Approval status of product in Reference BETA-VAL 0.1% ointment (USFDA)
Me-too status Betacin of Geofman Pharmaceuticals
“It is advised to overcome the shortcomings and
submit the compliance report to the competent
authorities so that the inspection could be
conducted accordingly.”
Decision of 283:
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm on
priority and licensing division for licensing status.
Last GMP inspection conducted on 4-6-2018 and 16-7-2018, concludes:
“Keep in view that most of the observations are rectified by the management so maintaining
satisfactory GMP compliance.”
Decision:
599. Name and address of manufacturer / M/s Demont Research Laboratories. 20km,
Applicant Lahore-Sharikpur Road, Sheikhupura,
Pakistan
Brand Name +Dosage Form + Strength Demnac 75/200mg Tablet
Diary No. Date of R& I & fee Form-5 Dy.No 26421 dated 28-12-2017 Rs.
20,000 Dated 28-12-2017
Diclofenac Sodium…75mg
Misoprostol…200Ug
Pharmacological Group (Cytoprotactant/NSAID)
Type of Form Form-5
Pack Size & Demanded Price 1x12’s
As per SRO
Approval Status of Product in Reference NA
Regulatory Authorities. (Arthrotec 75 modified-release tablets (MHRA)
but as gastro resistant)
Me-too Status ARTHO PLUS of Shaigan
GMP status Last GMP Inspection of Conducted on
23/2/2018, 26/2/2018 and report shows
satisfactory cGMP level.
Remarks of the Evaluator. Each tablet consists of a gastro-resistant core
containing 75 mg diclofenac sodium surrounded
by an outer mantle containing 200 micrograms
misoprostol But firm applied as film coated
tablet
Decision of 286:
Deferred for revision of formulation and label claim as per the USFDA approved
Reference product.
Revised Form 5, and formulation as gestro resistant core containing 75 mg diclofenac sodium
surrounding by an outer mantle of 200 microgram of misoprostol along with the fee of 5000/-(
Deposit slip # 0820236, dated:31-1-2019) is submitted.
Decision:
Pakistan
Brand Name +Dosage Form + Strength Demzoflex 2mg Tablet
20,000 Dated 28-12-2017
Composition Each Film coated Tablet Contains:
Tinzanidine as Hydrochloride…2mg
Pharmacological Group Muscle Relaxant
Type of Form Form-5
As per SRO
Regulatory Authorities. Tizanidine 2mg uncoated Tablets Actavis UK
Ltd (MHRA)
Me-too Status Analar by AGP
23/2/2018, 26/2/2018 and report shows
Remarks of the Evaluator. Tablet is approved as uncoated tablet in
reference regulatory authority.
Decision of 286:
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.
Revised Form 5, and master formulation as uncoated tablet i.e.
Each uncoated Tablet Contains:
along with the fee of 5000/-( Deposit slip # 0820237, dated:31-1-2019) is submitted.
Decision:
Pakistan
Brand Name +Dosage Form + Strength Demzoflex 4mg Tablet
20,000 Dated 28-12-2017
Type of Form Form-5
As per SRO
Approval Status of Product in Reference Tizanidine of MHRA approved
Me-too Status Musidin of M/s Martin Dow
23/2/2018, 26/2/2018 and report shows
Remarks of the Evaluator. Tablet is approved as uncoated tablet in
reference regulatory authority.
Decision of 286:
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
Revised Form 5, and master formulation as uncoated tablet i.e.
Each uncoated Tablet Contains:
along with the fee of 5000/-( Deposit slip # 0820238, dated:31-1-2019) is submitted.
Decision:
602. Name and address of manufacturer / M/s. Rakaposhi Pharmaceuticals, 97-K
Applicant Industrial Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Gesteron 10 mg tablet
Composition Each Film coated tablet contains:-
Dydrogesteron……10 mg
Diary No. Date of R& I & fee Dy. No.1046; 10-1-2017; Rs. 20,000/-
Pharmacological Group Progestogen
Type of Form Form-5
Approval status of product in Reference Duphaston by BGP Products
Regulatory Authorities (Swissmedic Approved)
Me-too status Duphaston by Abbott
GMP status Last GMP Inspection dated …. with conclusive
remarks of good cGMP compliance.
Remarks of Evaluator Letter was issued to the firm ;
 Approval of section/manufacturing
facility by the Central Licensing Board
for hormonal products. However, you
may submit panel inspection report for
renewal of DML verifying the
section/manufacturing facility
 Latest GMP inspection report (which
should have been conducted within the
period of last one year).
 As Firm don’t have approved section so
they switch to contract manufacturing by
Aries Pharmaceuticals and revised fee
and dossier is received.
Details are as under
603. Name and address of manufacturer / M/s. Rakaposhi Pharmaceuticals, 97-K
Applicant Industrial Estate, Hayatabad, Peshawar
contract manufacturing by M/s. Aries
Pharmaceuticals (Pvt) Ltd. 1-W, Industrial
Estate, Hayatabad Peshawar, Pakistan
Brand Name +Dosage Form + Strength Gesteron 10 mg tablet
Dydrogesteron……10 mg
Diary No. Date of R& I & fee Dy. No.8122, 5-3-1-2018; Rs. 20,000/- +30000/-
Pharmacological Group Progestogen
Form-5
As per SRO
Approval status of product in Reference Duphaston by BGP Products
Regulatory Authorities (Swissmedic Approved)
Me-too status Duphaston by Abbott
GMP status Last GMP inspection of Aries pharma was
conducted on 4-June-2018 with satisfactory
GMP compliance
Remarks of evaluator Rakaposhi is already contract manufacturing 1
product.
Decision 283:
Defered for further delebration on cis/trans isomers of Dydrogesteron
The firm claims that aries already has been given registration of this product for their company.
But this can’t be verified from our database.
Evaluator PEC-VIII
604. Name and address of Manufacturer / M/s Rock Pharmaceuticals Laboratories (Pvt) Ltd. 134-
Applicant B & 135-B Nowshera Industrial Estate, Risalpur.
Brand Name +Dosage Form +Strength Xocip 750mg tablets
Ciprofloxacin (as hydrochloride monohydrate)…750mg
Type of Form Form-5
Pack Size & Demanded Price 10’s; As per SRO
Me-too status Ciprobid tablet 750mg of Nova pharmaceuticals
GMP status GMP inspection conducted on 07-12-2017 does not
have conclusive remarks.
Previous Decision Registration Board in its 281st meeting referred the case
to QA & LT Division to conduct GMP inspection of
Firm on priority.
Evaluation by PEC Firm has submitted GMP Inspection Report dated 18th
of July, 2018 with conclusive remarks that firm is
complying cGMP.
Decision:
Brand Name +Dosage Form +Strength Tiglit-M tablet 50/500
Type of Form Form-5
Firm on priority.
complying cGMP.
Decision:
Brand Name +Dosage Form +Strength Tiglit-M tablet 50/1000
Type of Form Form-5
Firm on priority.
complying cGMP.
Decision:
Brand Name +Dosage Form +Strength Robifen tablet 100mg
Flurbiprofen…100mg
Type of Form Form-5
Pack Size & Demanded Price 6×5’s; As per SRO
Approval status of product in Reference Approved in ANSM
Me-too status Biofen 100mg Tablet of Mission Pharma
Firm on priority.
complying cGMP.
Decision:
Brand Name +Dosage Form +Strength Robecide 200mg/5ml suspension
Metronidazole(as benzoate)…200mg
Diary No. Date of R&I & fee DyNo.5030or 5630; 07-06-2017; Rs. 20,000/-
Pharmacological Group Amoebicide
Type of Form Form-5
Pack Size & Demanded Price 1’s (60ml); As per SRO
Me-too status Mogel 200mg Suspension of M/s Metro Pharma
Firm on priority.
complying cGMP.
Decision:
Evaluator PEC-IX
609. Name and address of Berlex Lab. International, 10 Km Nangshah Chowk Karachi Road,
manufacturer / Applicant Multan
Brand Name +Dosage Bercocin Capsule 500mg
Form + Strength
Lincomycin as HCl monohydrate……. 500mg
fee PKR 20,000/-: 21.04.2017
Pharmacological Group Lincosamides
Type of Form Form 5
Specification
Pack size & Demanded 2x6’s; Rs. 97/-
Price
Approval status of product Lincocine 500 mg capsule (Lincomycin as HCl hydrate) by Pfizer
in Reference Regulatory Holding France. Approved by ANSM France
Authorities.
Me-too status Linnco 500mg Capsule (Lincomycin as HCl) by Mafins
Pharmaceuticals (Pvt) Ltd., Karachi. Reg. No. 79898
GMP status The firm was last inspected on 05.07.2018, wherein the panel
recommended renewal of DML
Remarks of the Evaluator.  The USP has specified Raman spectroscopy for dissolution
study of Lincomycin capsules. However, upon clarification, the firm
did not provide proof of provision of Raman spectrophotometer.
 The firm revised the formulation to Lincomycin as HCl
monohydrate (in Master Formula) from Lincomycin HCl without
submission of fee. However, Form 5 still has Lincomycin HCl.
Previous decision  The Board in its 286th meeting deferred the case for
provision of Raman spectrophotometer and correction of Form 5.
Evaluation by PEC  The firm submitted revised Form 5 and requested for BP
specifications instead of USP specifications.
 Decision:
AD PEC- XIII
610. Name and address of manufacturer / M/s Amarant Pharmaceuticals, 158 D. Tore,
Applicant Gadap Road, Superhighway Karachi
Brand Name +Dosage Form + Strength Telmipine Tablet 80/5mg
Telmisartan……....80mg
Amlodipine…….….5mg
2017)
Finished product Specification Innovator's Specs
Pack size & Demanded Price 10’s,14’s/As per SRO
Me-too status Amtas Tablet by M/s Getz Pharma Karachi
GMP status Not provided
Previous remarks of the Evaluator GMP inspection needs to be conducted.
Previous decision In 279th meeting, Registration Board referred the
case to QA & LT Division to conduct GMP
inspection of Firm on priority.
Evaluation by PEC  Firm has now submitted its latest GMP
inspection report Dated: 24-07-2018 and
the report concludes good level of GMP
compliance.
Telmisartan………..80mg
2017)
compliance.
th
Decision of 288 meeting:
Telmisartan……....40mg
2017)
compliance.
Telmisartan……......40mg
2017)
compliance.
th
Decision of 288 meeting:
614. Name and address of manufacturer / M/s Avant Pharmaceuticals, M- 028 H.I.T.E.,
Applicant Lasbela, Balochistan
Brand Name +Dosage Form + Strength Cetofast tablet 20mg
Escitalopram as Oxalate ………20mg
Diary No. Date of R& I & fee Dy.No.22906; 04-12-2017; Rs.20,000(21-11-2017)
Pharmacological Group Anti-psychotic
Type of Form Form-5
Approval status of product in Reference CIPRALEX 20 mg film-coated tablets (MHRA)
Me-too status Repram 20mg tablet of M/s Regal Pharma
(Reg. # 081963)
and the report concludes good GMP compliance.
Previous remarks of the Evaluator The firm has applied Anti-psychotic while in
WHO ATC index it is Antidepressant (SSRI).
Previous decision Deferred for applied pharmacological group as the
firm has applied Anti-psychotic while in WHO
ATC index it is Antidepressant (SSRI).
Evaluation by PECXIII  Firm has submitted its correct
pharmacological group as SSRI (Anti-
depressant).
615. Name and address of manufacturer / M/s Avant Pharmaceuticals, M-028 H.I.T.E.,
Brand Name +Dosage Form + Strength Lemowin tablet 25mg
Lamotrigine ……………..25mg
Pharmacological Group Anti- epileptic/ Anti- convulsant
Type of Form Form-5
Me-too status Lamictal 25mg tablet of M/s GSK (Reg. # 014918)
Previous remarks of the Evaluator Firm has applied as film-coated tablet while the
applied formulation is approved in MHRA as
uncoated.
Previous decision 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
Evaluation by PECXIII  Firm has submitted Rs. 5000/- for change
of formulation from film-coated to
uncoated tablet
 Firm has revised its label claim as,
“ Each uncoated tablet contains:”
 Firm has also revised its master
formulation as un-coated tablet.
Brand Name +Dosage Form + Strength Lemowin tablet 50mg
Lamotrigine ……………..50mg
Pharmacological Group Anti-epileptic/ Anti-convulsant
Type of Form Form-5
Me-too status Lamotrin 50mg tablet of M/s Swan Pharma
(Reg. # 083016)
Previous remarks of the Evaluator Firm has applied as film-coated tablet while the
applied formulation is approved in MHRA as
uncoated.
Previous decision Deferred for submission of evidence of approval of
applied formulation as “film-coated tablets” in
were adopted by the Registration Board in its
275th meeting or else the formulation may be
revised in accordance with reference product along
Evaluation by PECXIII  Firm has submitted Rs. 5000/- for change
of formulation from film-coated to
uncoated tablet
 Firm has revised its label claim as,
“ Each uncoated tablet contains:”
 Firm has also revised its master
formulation as un-coated tablet.
Brand Name +Dosage Form + Strength Avemate 25mg Tablet
Topiramate ……………....25mg
Diary No. Date of R& I & fee Dy.No.22917;04-12-2017;Rs.20,000 (04-12-2017)
Pharmacological Group Anti- psychotic
Me-too status Tritop 25mg tablet of M/s Semos Pharma (Reg. #
075818)
Previous remarks of the Evaluator Firm has submitted its applied pharmacological
group as Antipsychotic while it is Antiepileptic
according to WHO ATC index (N03AX11).
Previous decision Deferred for correction of applied pharmacological
group as the firm has submitted its
pharmacological group as Antipsychotic while it is
Antiepileptic according to WHO ATC index
(N03AX11)
Evaluation by PECXIII  Firm has submitted its correct
pharmacological group as Anti- epileptic.
618. Name and address of manufacturer / M/s Avant Pharmaceuticals, M- 028 H.I.T.E.,
Brand Name +Dosage Form + Strength Avemate 50mg Tablet
Topiramate ……………....50mg
2017)
Pharmacological Group Anti- psychotic
Me-too status Tritop 50mg tablet of M/s Semos Pharma (Reg. #
075818)
Previous remarks of the Evaluator Firm has submitted its applied pharmacological
Previous decision Deferred for correction of applied pharmacological
group as the firm has submitted pharmacological
Evaluation by PEC XIII
 Firm has submitted its correct
pharmacological group as Anti- epileptic.
619. Name and address of manufacturer / M/s Z- Jans Pharmaceuticals, 148-A, Industrial
Applicant Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Alpa- Z tablet 0.5mg
Alprazolam…0.5mg
Diary No. Date of R& I & fee Dy.No.4117;28-12-2016; Rs.20,000/- (28-12-
2016)
Pharmacological Group Anxiolytic / Benzodiazepine derivative
Finished product Specification U.S.P
Pack size & Demanded Price as per SRO & as per SRO
Approval status of product in Reference Australia (TGA Approved)
Me-too status Xanax tablet 0.5mg of M/s Pfizer Pharmaceuticals
(Reg. # 012303)
GMP status Latest GMP inspection was conducted on 07-11-
2017 and the submitted report does not mention
any
conclusion.
Previous remarks of the Evaluator  The applied dosage form i.e. tablet is not
mentioned on fee- challan and strength is
being overwritten as 0.5mg above 0.25mg
under deposit slip # 0569580.
 Submitted GMP inspection report does not
mention any conclusion.
 Firm has psychotropic section.
Previous decision Deferred in 281st DRB meeting for following
reasons:
 Updated status of GMP of the firm from
QA & LT division as inspection report
submitted by firm does not conclude GMP
compliant status.
 Clarification of fees from Budgets and
Accounts Division against the applied
dosage form and strength.
Evaluation by PEC  The firm has submitted its latest inspection
report conducted on 03-07-2018 and 02-
08-2018 and the report concludes
rectification of observations with grant of
GMP certificate.
 Verification of fee- challan could not be
confirmed by the firm.
620. Name and address of manufacturer / M/s Rock Pharmaceutical Laboratories (Pvt.)
Applicant Limited, 134-B & 135-B, Noushehra Industrial
Estate, Risalpur
Brand Name +Dosage Form + Strength Roxart tablet 80mg/ 480mg
Artemether………………….80mg
Lumefantrine ……………...480mg
Pharmacological Group Antimalarial
Type of Form Form-5
Finished product Specification International Pharmacopoeia
Pack size & Demanded Price 4’s & as per SRO
Approval status of product in Reference WHO Approved formulation
Me-too status Artheget tablet 80mg/ 480mg of M/s Getz
Pharmaceuticals, Pak ( Reg. # 058405)
GMP status Last GMP inspection report dated 07-12-2017 with
no conclusion.
Previous remarks of the Evaluator  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.
Evaluation by PEC  Firm has now submitted its latest
inspection report conducted on 18-07-2018
and the report concludes grant of GMP
certificate.
621. Name and address of manufacturer / M/s Rock Pharmaceutical Laboratories (Pvt.)
Applicant Limited, 134-B & 135-B, Noushehra Industrial
Estate, Risalpur
Brand Name +Dosage Form + Strength Cafegot tablet 1mg/ 100mg
Ergotamine tartarate…………………...1mg
Caffeine ( anhydrous).……..……......100mg
Pharmacological Group Ergot Alkaloid/ Xanthine
Type of Form Form-5
Me-too status Cafergot of M/s Novartis Pharmaceuticals
GMP status Last GMP inspection report dated 07-12-2017 with
no conclusion.
Previous remarks of the Evaluator  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.
Evaluation by PEC  Firm has now submitted its latest
inspection report conducted on 18-07-2018
and the report concludes grant of GMP
certificate.
Evaluator PEC-XIV
622. Name and address of manufacturer / M/s Caylex Pharmaceuticals, (Pvt) Limited, 27-Km
Applicant Raiwind road Lahore.
Brand Name +Dosage Form + Strength AZOLOD Tablets 250mg
Azithromycin as Dihydrate…………..250mg
Diary No. Date of R& I & fee Dy.No. 8000/- dated 29-12-2010, 12000/- dated
28-10-13
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 20, 50,100, 250 and 500 tablets
Approval status of product in Reference Azithromycin 250 mg film-coated tablets by Milpharm
GMP status The firm has submitted copy of letter from QA division
vide letter No.F. 4-17/98-QA dated 4th January, 2018 in
which the Director QA & LT has allowed resuming the
production of the firm M/s Caylex Pharma except in
Cephalosporin section.
Previous remarks of the Evaluator. 
Previous decision(s) Deferred for rectification f following: (M-250)
a. Evidence of approval of section from Drug Licensing
Division is not submitted.
b. Methylene chloride is used in film coating which is
class II solvent and its use has been restricted because of
its inherent toxicity.
c. Inspection of the firm was carried out on 13-05-14 by
the panel of inspectors and number of observations/
shortcomings pointed out during the inspection.
Evaluation by PEC  Diary No. is not mentioned.
 The firm has submitted coating without methylene
chloride.
Decision:
Brand Name +Dosage Form + Strength AZOLOD Tablets 500mg
Azithromycin as Dihydrate…………..500mg
Diary No. Date of R& I & fee Dy.No. 738, 8000/- dated 29-12-2010, 12000/- dated 28-
10-2013
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 20, 50,100, 250 and 500 tablets
Approval status of product in Reference Azithromycin 500 mg Film-Coated Tablets by TEVA UK
Me-too status Zetro 500mg Tablet by Getz Pharma (Reg # 053120)
Evaluation by PEC  The firm has submitted coating without methylene
chloride.
Decision:
Brand Name +Dosage Form + Strength IROP Syrup
Iron protein succinylate 800mg equivalent to elemental
Iron……………..40mg
Diary No. Date of R& I & fee Dy.No. 738, 8000/- dated 29-12-2010, 12000/- dated 28-
10-2013
Type of Form Form-5
Finished product Specification Manufacturer specs
Pack size & Demanded Price As per SRO/ Pack of 30, 60,90, 120 and 450ml
Approval status of product in Reference Approved in Italy
Me-too status Wincuss Syrup 800mg/15 ml of Winthrox Karachi.
Previous decision(s) Deferred for rectification of following: (M-250)
b. Inspection of the firm was carried out on 13-05-14 by
Evaluation by PEC 
Decision:
Brand Name +Dosage Form + Strength O-CIN Tablet 400mg
Ofloxacin…………………400mg
Diary No. Date of R& I & fee Dy.No. , 8000/- dated 29-12-2010, 12000/- dated 28-10-
2013
Pharmacological Group Fluoroquinolones
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 10, 20, 30, 50, 100, 250, and 500’s
Approval status of product in Reference Tarivid 400 of MHRA approved
Me-too status Clamocid 400mg Tablets by M/s Rock Pharmaceuticals
Laboratories
Evaluation by PEC  Diary No. is not mentioned.
chloride.
Decision:
Brand Name +Dosage Form + Strength BISUB Tablet 265mg
Bismuth Subsalicylate……………...265mg
2013
Pharmacological Group Mucosal protective
Type of Form Form-5
b. Evidence of approval of same generic, dosage form in
reference agencies is not submitted.
c. Applied drug is available locally as chewable tablet
however firm has applied film coated.
d. Inspection of the firm was carried out on 13-05-14 by
Decision:
Brand Name +Dosage Form + Strength BISUB Suspension
Bismuth subsalicylate……….….88mg
Diary No. Date of R& I & fee Dy.No. ,8000/- dated 29-12-2010, 12000/- dated 28-
10-2013
Pharmacological Group Anti-diarrhoeal
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60, 90, 120, and 450ml
Approval status of product in Reference Pepti-Calm 525.6mg/30ml Oral Suspension of The Boots
Regulatory Authorities. Company (MHRA approved)
Me-too status BISMOL Syrup of Macter International
Division is required.
Decision:
Brand Name +Dosage Form + Strength K-ZIM Syrup 100mg/ 5ml
Cefixime as Trihydrate………....100mg
2013
Pharmacological Group Cephalosporin antibiotic
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60, 90, 120, 450ml
Approval status of product in Reference Cefixime 100 mg/5 ml Powder for Oral Suspension by
Regulatory Authorities. M/s Generics Ltd (MHRA Approved)
Me-too status Cefim Suspension 100mg/5ml by M/s Hilton Pharma
(Reg#022108)
b. Master formulation of liquid oral dosage form is
submitted.
c. Precautions/controls submitted for liquid oral dosage
form.
d. Finished product specifications are not submitted.
e. Inspection of the firm was carried out on 13-05-14 by
Moreover, the status of the section for applied
formulation is not clear from the report.
Evaluation by PEC  Reference formulation is Powder for oral suspension
while applied formulation is syrup.
Decision:
Brand Name +Dosage Form + Strength CAYMOL Plus Tablet
Paracetamol…………...200mg
Aspirin……………..…300mg
2013
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60, 90, 120, 450ml
Me-too status Liskoprin of Lisko Pvt Limited.
Division is not provided.
b. Evidence of approval of same generic, dosage form
and strength in reference drug agencies need to be
submitted.
Evaluation by PEC  Approval status in reference agency is required to be
submitted.
Decision:
Brand Name +Dosage Form + Strength CAYBION Capsules 50mg
Diclofenac sodium enteric coated pellets (32%)……50mg
2013
Type of Form Form-5
Approval status of product in Reference Approved in ANSM
Me-too status Amfac Capsules of Ambrosia Pharma (Reg#056576)
and strength in reference agencies is not submitted.
c. Source of Diclofenac sodium pellets, their composition,
certificate of analysis, stability studies as per zone IV and
in case of import of pellets, legalized GMP certificate of
the source along with the requisite fee prescribed under
the rules is not submitted.
Evaluation by PEC  Diary no. is missing
 Source of Pellets: M/s Vision Pharma (Diclofenac
sodium Enteric coated pellets 32%)
Decision:
Brand Name +Dosage Form + Strength CAYBION Capsules SR 100mg
Diclofenac sodium SR pellets (32%)……………..100mg
2013
Type of Form Form-5
Approval status of product in Reference Diclomax Retard 100mg modified release capsules of
Regulatory Authorities. Galen Ltd., UK (MHRA approved)
Me-too status Flamex SR capsules 100mg of M/s Werrick Pharma
(Reg#020592)
and strength in reference agencies is not submitted.
c. Source of Diclofenac sodium pellets, their composition,
certificate of analysis, stability studies as per zone IV and
in case of import of pellets, legalized GMP certificate of
the source along with the requisite fee prescribed under
the rules is not submitted.
shortcomings pointed out during the inspection
Evaluation by PEC  Source of Pellets: M/s Vision Pharma (Diclofenac
sodium SR pellets 32%)
 Diary no. is missing.
Decision:
Brand Name +Dosage Form + Strength C-PHOS Tablet 250mg
Chloroquine Phosphate …………...250mg
2013
Type of Form Form-5
Me-too status Cloroquin 250mg Tablet of klifton Pharma (Reg#058332)
a. Formulation is approved in reference drug agencies as
uncoated tablet however applied formulation is film
coated.
b. Reference of finished product spec need to be
submitted as it is included in official pharmacopeia.
Evaluation by PEC  Diary no. is missing.
Decision:
Brand Name +Dosage Form + Strength DIMIN Tablet 50mg
Diphenhydramine Hydrochloride……….50mg
2013
Type of Form Form-5
Finished product Specification Manufacturer’s specs
Previous decision(s) Deferred for rectification of following:
and strength in reference drug agencies is not submitted.
c. Me too status submitted is needs confirmation.
Decision:
Brand Name +Dosage Form + Strength GEMFLOX Tablet 320mg
Gemifloxacin as mesylate……………..…..320mg
2013
Type of Form Form-5
Approval status of product in Reference Factive Tablets of LG Life Sciences (USFDA approved)
Me-too status Gemixa Tablets of Bosch Pharma Karachi
b. Methylene chloride is used as coating solvent which is
class II as per ICH and its use has been restricted due to
its inherent toxicity
chloride.
Decision:
Brand Name +Dosage Form + Strength MOXILEX Tablet 400mg
Moxifloxacin as Hydrochloride…………..400mg
2013
Type of Form Form-5
Approval status of product in Reference Avelox of Bayer UK (MHRA approved)
Me-too status Avelox of Bayer Health Care Karachi
b. Methylene chloride is used as coating solvent which is
class II as per ICH and its use has been restricted due to
its inherent toxicity
chloride.
Decision:
Brand Name +Dosage Form + Strength DOXIN Tablet
Doxylamine Succinate………........10mg
Pyridoxine hydrochloride……..…..10mg
10-2013
Pharmacological Group Anti-histamine + Vitamin B6
Type of Form Form-5
Approval status of product in Reference Doxylamine Succinate And Pyridoxine Hydrochloride
Regulatory Authorities. (10/10) | ANDA #205811 | Tablet, Delayed Release;Oral |
Prescription | Actavis Labs Fl Inc. Approved in USFDA
Me-too status Nausidox 10mg/10mg Tablet of OBS (Reg#076292)
c. Methylene chloride issued in film coating which is
chloride.
 The formulation is not as per reference
Decision:
Brand Name +Dosage Form + Strength FERRO-G Syrup
Ferrous Gluconate 300mg equivalent to elemental
Iron……………...34mg
10-2013
Pharmacological Group Haematinic
Type of Form Form-5
Me-too status Lawrgluconate of Lawrance Pharma (Reg#071165)
Decision:
Brand Name +Dosage Form + Strength FAPA SR Capsules 100mg
Diclofenac Potassium pellets 32% eq. to Diclofenac
potassium……….100mg
10-2013
Type of Form Form-5
Me-too status Difene 100mg SR Capsule of M/s Aries (Reg#060292)
and stength in FDA, TGA, EMA, Health Canada and in
regultory body of Japan needs to be submitted.
c. Evidence of local availability submitted needs
confirmation.
d. Source of Diclofenac sodium pellets, their
composition, certificate of analysis, stability studies as
per zone IV and in case of import of pellets, legalized
GMP certificate of the source along with the requisite fee
prescribed under the rules is not submitted.
e. Inspection of the firm was carried out on 13-05-14 by
Decision:
Brand Name +Dosage Form + Strength PROLOL Tablet 5mg
Bisoprolol Fumarate………………5mg
10-2013
Pharmacological Group Cardio selective Beta Blocker
Type of Form Form-5
Approval status of product in Reference Bisprolol tablets of Accord health care UK (MHRA
Regulatory Authorities. approved)
Me-too status Bison Tablets of M/s Siza Int (Reg#024042)
b. Methylene chloride issued in film coating which is
chloride.
Decision:
Brand Name +Dosage Form + Strength CALCILEX Chewable Tablet
Composition Each chewable tablet contains:
Calcium Gluconate………………..500mg
10-2013
Pharmacological Group Calcium supplement
Type of Form Form-5
and strength in reference drug agencies is not provided
c. Evidence of local availability submitted needs
confirmation.
Decision:
Brand Name +Dosage Form + Strength CAYMINATE Syrup
Dimenhydrinate…………………..12.5mg
10-2013
Pharmacological Group Antiemetic
Type of Form Form-5
Approval status of product in Reference Dimenhydrinate oral Liquid of ALRA (Discontinued in
Regulatory Authorities. USFDA)
Me-too status Hydrinate Liquid of M/s Lisko (Reg#025593)
is not submitted.
Decision:
Brand Name +Dosage Form + Strength CIGAR Syrup
Pizotifen as hydrogen maleate………….….0.5mg
10-2013
Pharmacological Group Antimigraine drug
Type of Form Form-5
Approval status of product in Reference Sanomigran Elixir 0.25mg /5ml by M/s phoenix, (MHRA
Me-too status Aptigar Syrup (0.5mg/10ml) of Evergreen Pharma
(Reg#054398)
c. Dosage of applied formulation is not submitted
moreover the firm submitted that it is also used as
appetite stimulant.
d. Quantity of API submitted in master formulation is not
in conformance with the label claim.
e. Manufacturing method of cefixime syrup is submitted.
f. Inspection of the firm was carried out on 13-05-14 by
shortcomings pointed out during the inspection
Evaluation by PEC The firm has provided Oral Liquid section (General).
Decision:
Brand Name +Dosage Form + Strength ZINPHATE Suspension
Zinc Sulphate (monohydrate)……………10mg
Diary No. Date of R& I & fee Dy.No. 8000/- dated 29-12-10, 12000/- dated 28-
10-13
Pharmacological Group Zinc Supplement
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60,90, 120 and 450ml
Approval status of product in Reference WHO recommended
Me-too status Zinxus Suspension of M/s Ferozsons
b. Quantity of API submitted in master formulation is not
rational with the label claim.
Evaluation by PEC  The dosage form of Reference product is syrup while
that of applied formulation is suspension.
 Diary No. is not mentioned.
Decision:
644. Name and address of manufacturer / M/s Swan Pharmaceuticals, 11-E, Industrial triangle,
Applicant Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Axoff 40mg tablet
Febuxostat………..40mg
Diary No. Date of R& I & fee Dy.2685; 15-06-2016; Rs.20,000/- (15-06-2016)
Type of Form Form 5
Me-too status Febuxin by M/s AGP, Karachi (Reg. No. 081104)
GMP status Last inspection conducted on 21-12-2016.
Previous remarks of the Evaluator.  No official monograph is available for applied
formulation in USP or BP.
Previous decision(s) Deferred for updated status of GMP from QA&LT
Division (M-275).
Evaluation by PEC GMP inspection dated 21-12-2016 concluded that the
firm has to work very hard to improve and meet the
GMP guidelines as per Drug Act, 1976 and rules framed
thereunder. The company is advised to submit a
comprehensive plan of rectification/improvements and
then after rectifying the shortcomings submit
compliance report.
Decision:
Brand Name +Dosage Form + Strength Axoff 80mg tablet
Febuxostat………..80mg
Diary No. Date of R& I & fee Dy.2690; 15-06-2016; Rs.20,000/- (15-06-2016)
Type of Form Form 5
Me-too status Febuxin by M/s AGP, Karachi (Reg. No. 081105)
Previous remarks of the Evaluator.  No official monograph is available for applied
formulation in USP or BP.
Division (M-275).
compliance report.
Decision:
Brand Name +Dosage Form + Strength Paradol tablets
Paracetamol………..325mg
Tramadol hydrochloride………37.5mg
Pharmacological Group Analgesic/ Opioid Analgesic
Type of Form Form 5
Ultracet by Janssen (USFDA)
Me-too status Distalgesic Tablets by Atco laboratories, Karachi (R. No.
073865)
Division (M-275).
compliance report.
Decision:
Brand Name +Dosage Form + Strength Levictam 500mg tablet
Composition Each film coated tablets Contains:
Levetiracetam……….500mg
Pharmacological Group Second generation antiepileptic
Type of Form Form 5
Me-too status Keppra Tablets 500mg by M/s AGP (Pvt.) Ltd, Karachi
(Reg. No. 045685)
Division (M-275).
compliance report.
Decision:
Brand Name +Dosage Form + Strength Levictam 250mg tablet
Levetiracetam……….250mg
Pharmacological Group Second generation antiepileptic
Type of Form Form 5
Me-too status Keppra Tablets 250mg by M/s AGP (Pvt.) Ltd, Karachi
(Reg. No. 045684)
Division (M-275).
compliance report.
Decision:
Brand Name +Dosage Form + Strength Vamlodip-DS tablets
Amlodipine as besylate…………10mg
Valsartan……..160mg
Diary No. Date of R& I & fee Dy. 2686; 15-06-2016; Rs.20,000/- (15-06-2016)
Type of Form Form 5
Me-too status Valpine Tablets 10/160mg by M/s Fassgen
Pharmaceuticals, (Reg. No. 073303)
Division (M-275).
compliance report.
Decision:
Brand Name +Dosage Form + Strength Sertowan 50 mg tablet
Sertraline (as hydrochloride) …… 50mg
Pharmacological Group Selective serotonin reuptake inhibitors
Type of Form Form 5
Me-too status Ertalin 50 mg Tablets of M/s Genome pharmaceuticals,
(Reg.#076844)
Division (M-275).
compliance report.
Decision:
651. Name and address of manufacturer / M/s Seatle (Pvt) Ltd., 45-KM, Multan Road Lahore
Applicant
Brand Name +Dosage Form + Strength Phastive Capsule
Omeprazole ……20mg
Sodium Bicarbonate ……1100mg
PKR 20,000/-: 13-10-2015
Type of Form Form 5
Approval status of product in Reference Zegerid by Santarus Inc
Me-too status Faast plus by CCL
GMP status
Previous remarks of the Evaluator.  Latest GMP inspection report (which should have been
conducted within the period of last one year)
Previous decision(s) Deferred for GMP inspection report conducted within a
period of last 1 year (M-273).
firm was considered to be operating at GOOD level of
compliance with GMP guidelines as per Drugs Act, 1976
and rules framed thereunder.
Decision:
Applicant
Brand Name +Dosage Form + Strength Phastive Capsule
Omeprazole ……40mg
Sodium Bicarbonate ……1100mg
PKR 20,000/-: 13-10-2015
Pharmacological Group Antiulcer
Type of Form Form 5
Approval status of product in Reference Zegerid by Santarus Inc
Me-too status Faast plus by CCL
GMP status
Previous decision(s) Deferred for GMP inspection report conducted within a
period of last 1 year (M-273).
Decision:
Applicant
Brand Name +Dosage Form + Strength Dight Tablet 5mg
Rosuvastatin Calcium………..5mg
Diary No. Date of R& I & fee 209, 20-01-2016, 20,000/-
Pharmacological Group HMG Co-A reductase inhibitor
Type of Form Form-5
Finished product Specification As per innovator’s specifications
Pack size & Demanded Price 10’s, 20’s, 30’s; As per PRC
Approval status of product in Reference Crestor 5mg tablet of IPR (USFDA approved)
Me-too status Crestat Tablet of CCL
GMP status The panel inspection conducted on 11-12-14 & 09-1-2015
recommended the resumption of production.
Previous decision(s) Deferred for submission of latest GMP inspection report
which should have been conducted within period of one
year (M-274).
Decision:
Applicant
Type of Form Form-5
year (M-274).
Decision:
Applicant
Type of Form Form-5
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Riglip Tablets 50/500mg
Composition Each Tablets contains:-
Sitagliptin as phosphate…..50mg
Metformin HCl …...………500mg
Pharmacological Group Anti-diabetic (Type II Diabetes Mellitus)
Type of Form Form-5
Approval status of product in Reference Janumet film coated tablet 50/500mg of Merck Sharp &
Regulatory Authorities. Dohme (USFDA)
Me-too status Treviamet film coated tablet 50/500mg of M/s Getz
Pharmaceuticals
Previous remarks of the Evaluator.  Latest GMP inspection report (which should have
been conducted within period of one year).
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Riglip Tablets 50/1000mg
Composition Each Tablets contains:-
Sitagliptin as phosphate…..50mg
Metformin HCl (USP)………1000mg
Pharmacological Group Anti-diabetic (Type II Diabetes Mellitus)
Type of Form Form-5
Approval status of product in Reference Janumet film coated tablet 50/1000mg of Merck Sharp &
Regulatory Authorities. Dohme (USFDA)
Me-too status Treviamet film coated tablet 50/1000mg of M/s Getz
Pharmaceuticals
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Zyrian Capsule 50mg
Composition Each Capsule contains:-
Pregabalin……….…..50mg
Pharmacological Group Anti-epileptic
Type of Form Form-5
Approval status of product in Reference Lyrica capsule 50mg of Pfizer (USFDA approved)
Me-too status Dygab capsule 50mg of M/s Dyson Research Labs
year (M-274).
Decision:
Applicant
Type of Form Form-5
Approval status of product in Reference Lyrica Capsule by PF Prism CV (USFDA Approved)
Me-too status Gabica by Getz
year (M-274).
Decision:
Applicant
Type of Form Form-5
Approval status of product in Reference Lyrica Capsule by PF Prism CV (USFDA Approved)
Me-too status Gabica by Getz
year (M-274).
Decision:
Applicant
Type of Form Form-5
Approval status of product in Reference Lyrica 150mg Capsuleby M/s PF Prism CV, USFDA
Me-too status Gabica 150mg Capsule by M/s Getz Pharma
(Reg#048724)
GMP status The panel inspection conducted on 11-12-14 & 09-01-
2015 recommended the resumption of production.
year (M-274).
Decision:
Applicant
Type of Form Form-5
Approval status of product in Reference Lyrica 300mg Capsule by M/s PF Prism CV, (USFDA)
Me-too status Gabica 300mg Capsule by M/s Getz Pharma
(Reg#047368)
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Cygnet Tablet 500mg
Composition Each Film coated tablet Contains:-
Ciprofloxacin (as HCl)……500mg
Pharmacological Group Fluoroquinolone, antibacterial agent
Type of Form Form-5
Approval status of product in Reference Ciproxin by Bayer
Me-too status Ciprox tablet by Amson
year (M-274).
Decision:
Applicant
Diary No. Date of R& I & fee Nil (Duplicate), 20,000/-, 15-02-2016
Type of Form Form-5
Approval status of product in Reference Ciproxin by Bayer (MHRA Approved)
year (M-274).
Decision:
Applicant
Diary No. Date of R& I & fee Nil (Duplicate), 20,000/-, 15-02-2016
Type of Form Form-5
Approval status of product in Reference Ciproxin by Bayer (MHRA Approved)
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Goulle 20mg Capsule
Composition Each capsule of enteric coated pellets (22.5%w/w)
contains:-
Esomeprazole (as magnesium trihydrate)……….40mg
Type of Form Form-5
Pack size & Demanded Price 7’s,14’s & 28’s ; As per brand leader’s price/PRC
Me-too status E-Z Capsule 20mg of M/s English Pharm (Reg.# 050151)
recommends the resumption of production.
Previous remarks of the Evaluator.  Last inspection report conducted within last one year
by DRAP shall be submitted.
Firm has submitted following:
 Legalized copy of GMP certificate for M/s Precise
Chemipharma Pvt. Ltd, India (source of
Esomeprazole enteric coated 8.5% w/w pellets)
issued by FDA Maharashtra.
 COA of Esomeprazole enteric coated 8.5% w/w
pellets.
 Stability study data for Esomeprazole enteric coated
8.5% w/w pellets.
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Goulle 40mg Capsule
Composition Each capsule of enteric coated pellets (22.5%w/w)
contains:-
Esomeprazole (as magnesium trihydrate)…….40mg
Type of Form Form-5
Pack size & Demanded Price 7’s,14’s & 28’s ; As per brand leader’s price/PRC
Me-too status E-Z Capsule 40mg of M/s M/s English Pharm (Reg.#
050150)
recommends the resumption of production.
Previous remarks of the Evaluator.  Last inspection report conducted within last one year by
DRAP shall be submitted.
 Legalized copy of GMP certificate for M/s Precise
Chemipharma Pvt. Ltd, India (source of Esomeprazole
enteric coated 8.5% w/w pellets) issued by FDA
Maharashtra.
 COA of Esomeprazole enteric coated 8.5% w/w pellets.
 Stability study data for Esomeprazole enteric coated
8.5% w/w pellets.
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Troisa Cream
Composition Each Gram Contains:-
Eflornithine hydrochloride (as monohydrate)……139mg
Diary No. Date of R& I & fee Dy No. 2287: 26-5-2016PKR 20,000/-: 25-5-2016
Pharmacological Group Ornithine decarboxylase inhibitor
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g: As per SRO
Approval status of product in Reference Vaniqa cream by Skinmedica
Me-too status Depilus cream by Atco
GMP status
Previous remarks of the Evaluator. Latest GMP inspection report is not provided
year (M-274).
Decision:
Applicant
Brand Name +Dosage Form + Strength Leadmox Tablet
Composition Each Tablet contains:-
Moxifloxacin hydrochloride eq to Moxifloxacin….400mg
Type of Form Form-5
Me-too status Swismox 400mg Tablet of M/s Swiss, Karachi
year (M-274).
Decision:
670. Name and address of manufacturer / M/s. Abbott Laboratories (Pakistan) Ltd, Karachi.
Applicant
Brand Name +Dosage Form + Strength Moksi IV Infusion 400mg.
Composition 250ml infusion contains:
Moxifloxacin hydrochloride……400mg
Diary No. Date of R& I & fee Dy No. 304, 16/12/2014, Rs.20,000/-
Type of Form Form-5
Firm claimed that the Finished product specification are
neither available in any pharmacopoeia nor Innovator
Finished product Specification
specifications are present in any reference authority.
Therefore we request the DRAP to provide us finished
product specifications of innovator product since the
innovator product is registered with DRAP.
Pack size & Demanded Price 250mL, As per brand leader (Avelox).
Approval status of product in Reference Avelox 400mg/250ml solution for infusion by Bayer,
Regulatory Authorities. MHRA approved.
Me-too status Avelox 400mg Infusion by Bayer Healthcare.
GMP status Last GMP Inspection of M/s Abbott Laboratories
conducted on 15-02-2016 with conclusive remarks of
recommendation for the grant of additional section of
manufacturing of aseptically filled lyophilized products.
conducted within 1 year (M-269).
Evaluation by PEC Routine GMP inspection dated 24-10-2018 and 06-11-
2018 concluded that the building, facilities and
procedures demonstrated at the time of inspection found
at acceptable level of GMP compliance. The management
is also committed for continual improvement and has
assured further cGMP compliance.
Decision:
671. Name and address of manufacturer / M/s Jupiter Pharma
Applicant Plot # 25, St# S6 RCCI Rawat Rawalpindi.
Brand Name +Dosage Form + Strength Judol Tablet
Alfacalcidol……..…0.5mcg
Diary No. Date of R& I & fee Dy. No 2650, (13-06-2016), Rs. 20,000/-
Pharmacological Group Vitamin –D Analogue
Type of Form Form-5
Pack size & Demanded Price Pack of 1 x 10’s; As per DPC
Approval status of product in Reference PMDA approved
Me-too status Alfamak Tablets 0.5mcg of Makson (Reg#070017)
GMP status GMP inspection conducted on 31-01-2018 concluded
that M/s Jupiter Pharma is operating at a fair level of
cGMP compliance as of today.
Previous decision(s) Deferred as 10 molecules per section has already been
approved (M-260).
Evaluation by PEC The firm has provided Tablet section (General).
Decision:
672. Name and address of manufacturer / M/s Jupiter Pharma,
Applicant Plot # 25, St# S6 RCCI Rawat Rawalpindi.
Brand Name +Dosage Form + Strength Mides Tablet
Desloratadine ……………..5mg
Diary No. Date of R& I & fee Dy. No 2655, (13-06-2016), Rs. 20,000/-
Type of Form Form-5
Pack size & Demanded Price Pack of 1 x 10’s; As per DPC
Me-too status Alenor – Macter
GMP status GMP inspection conducted on 31-01-2018 concluded
that M/s Jupiter Pharma is operating at a fair level of
cGMP compliance as of today.
Previous decision(s) Deferred as 10 molecules per section has already been
approved (M-260).
Evaluation by PEC The firm has provided Tablet section (General).
Decision:
673. Name and address of manufacturer / M/s. Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km,
Applicant Feroz Pur Road, Lahore
Brand Name +Dosage Form + Strength Referox tablet 250mg
Deferasirox……. 250mg
Diary No. Date of R& I & fee Dy No. 29491: 03.09.2018
PKR 20,000/-: 03.09.2018
Pharmacological Group Iron chelating agents
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer specs.
Pack size & Demanded Price 10’s, 30’s
Approval status of product in Reference EXJADE 250 mg Tablets for oral suspension by Novartis
Regulatory Authorities. Pharma.
Approved by US-FDA
Me-too status Arefed 250 mg dispersible tablets, by Genome
Pharmaceuticals, Hattar, Reg. No. 85092
GMP status The firm was last inspected on 07.06.2017 & 30.08.2017,
wherein the panel recommended the renewal of DML
Previous decision(s) Registration Board referred the case to QA & LT
Division to conduct GMP inspection of Firm on priority.
(M-285)
Decision:
Brand Name +Dosage Form + Strength Referox tablet 500mg
Deferasirox……. 500mg
PKR 20,000/-: 03.09.2018
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer specs.
Pack size & Demanded Price As per SRO; 10’s, 30’s
Approval status of product in Reference EXJADE 500 mg Tablets for oral suspension by Novartis
Regulatory Authorities. Pharma.
Approved by US-FDA
Me-too status Arefed 500 mg dispersible tablets, by Genome
Pharmaceuticals, Hattar, Reg. No. 85093
(M-285)
Decision:
Brand Name +Dosage Form + Strength Voricon Tablet 200mg
Voriconazole…………200mg
Diary No. Date of R& I & fee Dairy No. 5614 dated 4.06.2013, Rs:20,000/-
Type of Form Form-5
Pack size & Demanded Price As Per SRO; 10’s
Me-too status Vozo 200mg Tablet of Hilton Pharma
renewal of DML.
Previous decision(s) Deferred for following: (M-258)
 Commitment as per 251st meeting of RB is required.
Availability in SRA is not provided by the firm.
Reference literature for detailed specification and
analytical method is required.
Latest Inspection Report is required.
Registration Board referred the case to QA & LT
(M-285)
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.
Decision:
Brand Name +Dosage Form + Strength Fuzo SR Tablet 10mg
Composition Each tablet contains:-
Alfuzosin HCl………….10mg
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 Reference Uroxatral extended release tablets, USFDA
Me-too status Luzio SR Tablet 10mg by Wilshire Laboratories,
renewal of DML.
 Availability in SRA is not provided by the firm.
 Reference literature for detailed specification and
 Latest Inspection Report is required.
(M-285)
The firm has submitted in-house specs and detail of
analytical method.
Decision:
Brand Name +Dosage Form + Strength Bami Tablet 600mg
Bamifylline Hydrochloride…………...600mg
Pharmacological Group (Bronchodilators & antiasthma)
Type of Form Form-5
Pack size & Demanded Price Rs. 361/-, 30’s
Approval status of product in Reference AIFA, Italy
Me-too status Bamifix Tablet 600mg by Chiesi Pharma
(M-285)
analytical method.
Decision:
Brand Name +Dosage Form + Strength Feriwin-F Tablet
Iron Protein Succinylate….……..20mg
Folic acid……………………2.5mg
Pharmacological Group Heamatinic Drug
Type of Form Form 5
Me-too status Sucrofer-F Tablets of CCL pharma (Reg#052640)
(M-285)
The firm has submitted revised Form-5 stating label claim
as below:
Each film coated tablet contains:-
Iron Protein Succinylate eq. to elemental Iron…..20mg
Folic acid…………………….…2.5mg
analytical method.
Decision:
679. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km, Feroz
Applicant Pur Road, Lahore
Brand Name +Dosage Form + Strength Termi 250mg Tablet
Diary No. Date of R& I & fee Dy.No 14606 dated 19-04-2018 Rs.20,000/- Dated 19-
04-2018
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per PRC
Me-too status Neoterbin Tablets 250mg by M/s Neomedix
Pharmaceuticals, Islamabad. (Reg.# 081411)
(M-285)
Decision:
680. Name and address of manufacturer / Shrooq Pharmaceuticals (Pvt.) Ltd., 21-km, Feroz
Applicant Pur Road, Lahore
Brand Name +Dosage Form + Strength Hirso 13.9% Cream
Composition "Each 100g Contains:
Eflornithine as Hydrochloride Monohydrate…..13.9g"
04-2018
Pharmacological Group Antiprotozoals
Type of Form Form-5
Me-too status Depilus Cream of M/s Atco Lab. Karachi (Reg.#
073868)
wherein the panel recommended the renewal of DML.
(M-285)
Decision:
681. Name and address of manufacturer / M/s Shrooq Pharmaceuticals (Pvt.) Ltd., 21-Km,
Applicant Feroz Pur Road, Lahore.
Brand Name +Dosage Form + Strength Micin Gel 1%
Composition Each g of gel contains:
Clindamycin as phosphate……1%
ATC Code; D10AF01
Type of Form Form 5
Pack size & Demanded Price 15g, 20g
Me-too status Uniclin Gel by M/s Kaizen Pharma, Karachi (Reg.
No. 076304)
Previous remarks of the Evaluator.  Duplicate dossier
(M-285)
Decision:
Brand Name +Dosage Form + Strength Isonon Plus Gel
Erythromycin…20mg
Isotretinoin…..0.5mg
Pharmacological Group Anti-acne preparations
ATC Code: D10AD54
Type of Form Form 5
Approval status of product in Reference Isotrexin® Gel (MHRA Approved)
Me-too status Tretocin by Derma tecno Pakistan
Previous remarks of the Evaluator.  Duplicate Dossier.
(M-285)
Decision:
Brand Name +Dosage Form + Strength Tacrus Ointment 0.03%
Pharmacological Group Agents for dermatitis, excluding corticosteroid
ATC Code: D11AH01
Type of Form Form 5
Approval status of product in Reference PROTOPIC (tacrolimus) Ointment 0.03%w/w by M/s
Regulatory Authorities. LEO PHARMA AS (USFDA Approved)
Me-too status Tacroderm Ointment 0.03% by M/s Caraway
Previous remarks of the Evaluator. Duplicate dossier
(M-285)
Decision:
Brand Name +Dosage Form + Strength Myfate DS Tablet
Sucralfate…1g
ATC Code: A02BX02
Type of Form Form 5
Approval status of product in Reference USFDA Approved (Uncoated)
Brand Name: SUCFATE 1GM TAB Each tablet
contains:- SUCRALFATE 1000mg
Manufacturer Name:SIZA
Previous remarks of the Evaluator. Firm has revised their formulation from film coated to
uncoated tablet without submission of fee.
(M-285)
Decision:
Brand Name +Dosage Form + Strength Tenovir Tablet 300mg
Tenofovir Disoproxil fumarate………300mg
12-2009,
Pharmacological Group Nucleoside reverse transcriptase inhibitors
ATC Code: J05AF07
Type of Form Form 5
Pack size & Demanded Price 30’s in PVC jar
Approval status of product in Reference Tenofovir by Teva Pharma
Me-too status Tenofo-B by Getz
Previous remarks of the Evaluator.  Approved with box warning in USFDA.
(M-285)
Case No. 03: Registration applications of newly granted DML or New section (Human)
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)
Dry powder injection 6 18
(Cephalosporin)
Dry powder suspension
(Cephalosporin)
The letter was issued on 8th January 2019.
Dry Powder injection (Cephalosporin) section: Molecules-6/ Products-18

686. Name and address of manufacturer / M/s Norwich Pharmaceuticals. Plot No. 220,
Brand Name +Dosage Form + Strength Cefron 250mg Injection
Composition Each Vial Contains:
Ceftazidime pentahydrate eq. to Ceftazidime…250mg
Diary No. Date of R& I & fee Dy. No. 3407 dated 24-01-2019
Rs.20,000/- Dated 24-01-2019
Pharmacological Group Cephalosporin
Type of Form Form 5
Approval status of product in Reference Fortum powder for solution for injection by M/s
Regulatory Authorities. GlaxoSmithKline UK (MHRA Approved)
Me-too status Panacef Injection by CCL
GMP status New license
Remarks of the Evaluator3.
Decision:
Brand Name +Dosage Form + Strength Cefron 500mg Injection
Ceftazidime pentahydrate eq. to Ceftazidime…500mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Cefron 1gm Injection
Ceftazidime pentahydrate Eq. to
Ceftazidime…1000mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Furox 750mg Injection
Cefuroxime sodium eq. to Cefuroxime…750mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Cefuroxime powder for solution for injection
Me-too status ZINACEF 750MG INJ by M/s GSK Pakistan
GMP status
Decision:
Brand Name +Dosage Form + Strength Furox 1.5gm Injection
Cefuroxime sodium eq. to Cefuroxime…1.5gm
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Cefuroxime powder for solution for injection
Me-too status Zecef Injection 1.5gm by Bosch Pharmaceuticals
Decision:
Brand Name +Dosage Form + Strength L-Pime 500mg Injection
Cefepime hydrochloride eq. to Cefepime…500mg
(with L-Arginine)
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Cefipime hydrochloride Injection by Hospira, Inc.
Regulatory Authorities. (USFDA approved)
Me-too status Uspime Injection by Usawa Pharmaceuticals
Decision:
Brand Name +Dosage Form + Strength L-Pime 1gm Injection
Cefepime hydrochloride eq. to Cefepime…1gm
(with L-Arginine)
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Cefipime hydrochloride Injection by Hospira, Inc.
Me-too status Uspime Injection by Usawa Pharmaceuticals
Decision:
Brand Name +Dosage Form + Strength Norbac 1gm Injection
Cefoperazone sodium Eq. to Cefoperazone…500mg
Sulbactam Sodium Eq. to Sulbactam…500mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Finished Product Specification JP Specs
Approval status of product in Reference PMDA Japan Approved
Me-too status Cebac Injection by Bosch Pharma
Decision:
Brand Name +Dosage Form + Strength Norbac 2gm Injection
Cefoperazone sodium Eq. to Cefoperazone…1000mg
Sulbactam Sodium Eq. to Sulbactam…1000mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Approved by 3 European countries:
Regulatory Authorities. Czech:
http://www.sukl.eu/modules/medication/detail.php?cod
e=0015273&tab=info
Slovakia:
https://www.sukl.sk/hlavna-stranka/english-
version/special-pages/medical-product-
detail?page_id=842&lie_id=6343A
Poland:
http://pub.rejestrymedyczne.csioz.gov.pl/?AspxAutoD
etectCookieSupport=1#results
Links are assessed on 1st Oct 2018
Me-too status Bezone Injection by Medisave
Decision:
Brand Name +Dosage Form + Strength Norcef 250mg IM Injection
Ceftriaxone sodium eq. to Ceftriaxone…250mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Rocephin Injection by Roche
R egulatory Authorities. (MHRA Approved)
Me-too status Rocephin Injection by Roche
Decision:
Brand Name +Dosage Form + Strength Norcef 250mg IV Injection
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Norcef 500mg IM Injection
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Norcef 500mg IV Injection
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Norcef 1gm IV Injection
Ceftriaxone sodium eq. to ceftriaxone…1000mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Norcef 2gm IV Injection
Ceftriaxone sodium eq. to ceftriaxone…2gm
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Decision:
Brand Name +Dosage Form + Strength Taxim 250mg Injection
Cefotaxime Sodium Eq. to Cefotaxime…250mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Claforan 250mg Injection by Sanofi Aventis
Regulatory Authorities. (Netherland Approved)
Me-too status Baxim Injection by Nabiqasim
Decision:
Brand Name +Dosage Form + Strength Taxim 500mg Injection
Cefotaxime sodium eq. to Cefotaxime…500mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Cefotaxime Injection
Decision:
Brand Name +Dosage Form + Strength Taxim 1gm Injection
Cefotaxime sodium eq. to Cefotaxime…1000mg
Rs.20,000/- Dated 24-01-2019
Type of Form Form 5
Approval status of product in Reference Cefotaxime Injection
Decision:
Evaluator PEC-IV
TABLET (GENERAL)
22 Products/ 10 Molecules
704. Name and address of M/s Invictus Pharmaceuticals.
manufacturer / Applicant Plot No. 21,26, Street No.NS-2, National Industrial
Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Linzovic 400mg Tablet
Strength
Linezolid…400mg
01-2019
Type of Form Form 5
Finished product Specifications Manufacturers specification
Pack size & Demanded Price 10’s, 12’s, & 14’s ;As per SRO
Approval status of product in Zyvox 400 mg tablet of (USFDA approved)
Me-too status (with strength and Barizold 400mg Tablet by M/s Barrett Hodgson (Reg
dosage form) No:076342)
GMP status Last inspection conducted on 13-11-2018 and panel
recommend grant of DML
Decision:
Brand Name +Dosage Form + Linzovic 600mg Tablet
Strength
Linezolid…600mg
01-2019
Type of Form Form 5
Pack size & Demanded Price 10’s, 12’s, & 14’s ;As per SRO
Approval status of product in Zyvox 400 mg tablet of (USFDA approved)
Me-too status (with strength and Ecasil 600mg tablet by M/s Sami (Reg#066904)
dosage form)
Decision:
Brand Name +Dosage Form + Itopic 50mg Tablets
Strength
Composition Each film coated Tablet Contains:
Itopride as HCL…50mg
01-2019
Pharmacological Group Prokinetics
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s , 1 x 20’s, 1 x 30’s & 1 x 50’s; As per SRO
Approval status of product in Ganaton of M/s Abbott Laboratories (PMDA) Japan
Reference Regulatory Authorities Approved
Me-too status (with strength and Itop 50mg Tablet by M/s Nexus.
dosage form)
Decision:
Brand Name +Dosage Form + Itopic 150mg Tablets
Strength
Itopride as HCL…150mg
01-2019
Pharmacological Group Prokinetics
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s , 1 x 20’s, 1 x 30’s & 1 x 50’s; As per SRO
Approval status of product in Ganaton of M/s Abbott Laboratories (PMDA) Japan
Reference Regulatory Authorities Approved
Me-too status (with strength and Dysrid-150mg Tablets by M/s Onyx Pharmaceuticals
dosage form)
Decision:
Brand Name +Dosage Form + Creva 10mg Tablets
Strength
Rosuvastatin…10mg
01-2019
Pharmacological Group Statin or HMG CoA Reductase Inhibitor
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)
Remarks of the Evaluator4 Correction of Salt form Rosuvastatin as calcium without
submission of fee
Decision:
Strength
Rosuvastatin…20mg
01-2019
Me-too status (with strength and Easetec 20mg tablet by M/s Pharmatec (Reg#067565)
dosage form)
submission of fee
Decision:
Strength
Rosuvastatin…40mg
01-2019
Me-too status (with strength and Rosocard Tablets of M/s Himont Pharma
dosage form)
submission of fee
Decision:
Brand Name +Dosage Form + Lorvic 4mg Tablets
Strength
Lornoxicam…4mg
01-2019
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s , 1 x 20’s, 1 x 30’s ; As per SRO
Me-too status (with strength and LoxiBar 4mg Tablet Of M/S Barret Hodgson
dosage form)
Decision:
Brand Name +Dosage Form + Lorvic 8mg Tablets
Strength
Lornoxicam…8mg
01-2019
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s , 1 x 20’s, 1 x 30’s ; As per SRO
Me-too status (with strength and LoxiBar 8mg Tablet Of M/S Barret Hodgson
dosage form)
Decision:
Brand Name +Dosage Form + Rison 1mg Tablets
Strength
Risperidone…….…1mg
01-2019
Type of Form Form 5
Pack size & Demanded Price 10’s ,20’s, 30’s As per SRO
dosage form)
Decision:
Strength
01-2019
Type of Form Form 5
dosage form)
Decision:
Strength
01-2019
Type of Form Form 5
dosage form)
Decision:
Strength
01-2019
Type of Form Form 5
dosage form)
Decision:
Brand Name +Dosage Form + Arovent 10mg Tablets
Strength
Montelukast as Sodium…10mg
01-2019
Pharmacological Group Anti-asthmatic
Type of Form Form 5
Pack size & Demanded Price 1 x 14’s , 1 x 28’s ; As per SRO
Approval status of product in Ga Singulair Of (USFDA Approved)
Me-too status (with strength and Mecost 10mg Tablet M/s Sigma
dosage form)
Decision:
Brand Name +Dosage Form + Lomide 50mg Tablets
Strength
Lacosamide…….…50mg
01-2019
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s, 1 x 20’s & 1 x 30’s ; As per SRO
Approval status of product in Vimpat tablet of (USFDA approved)
Me-too status (with strength and Nurosa 50mg Table M/s Helix Pharma
dosage form)
Decision:
Strength
01-2019
Type of Form Form 5
Me-too status (with strength and Nurosa 100mg Table M/s Helix Pharma
dosage form)
Decision:
Strength
01-2019
Type of Form Form 5
Me-too status (with strength and Atcomid 200mg Tablet M/s Atco Lab
dosage form)
Decision:
Brand Name +Dosage Form + Cox-E 30mg Tablets
Strength
Etoricoxib….…30mg
01-2019
Pharmacological Group Anti-inflammatory and anti-rheumatic drugs
Type of Form Form 5
Finished product Specifications Manufacturer,s specification
Approval status of product in Arcoxia 30mg tablet Of ( (MHRA Approved)
dosage form)
Decision:
Brand Name +Dosage Form + Cox-E 60mg Tablets
Strength
Etoricoxib….…60mg
01-2019
Pharmacological Group Anti-inflammatory and anti-rheumatic drugs
Type of Form Form 5
Approval status of product in Arcoxia 60mg tablet Of ( (MHRA Approved)
Me-too status (with strength and Etroxin tablet 60mg Of M/S Akson Pharmaceuticals
dosage form)
Decision:
Brand Name +Dosage Form + Epiral 50mg Tablets
Strength
Eperisone…….…50mg
01-2019
Pharmacological Group Muscle relaxant, Centrally acting agent
Type of Form Form 5
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 (Reg# 039302)
dosage form)
Remarks of the Evaluator4 Correction of Salt form Eperisone as HCl without submission
of fee .
Decision:
Brand Name +Dosage Form + Dep CR 12.5mg Tablet
Strength
Composition Each enteric film coated Tablet Contains:
Paroxetine…….…12.5mg
01-2019
Pharmacological Group Selective serotonin-reuptake inhibitors
Type of Form Form 5
Approval status of product in PAXIL CR of (USFDA approved)
Me-too status (with strength and Panox CR Tablet 12.5 mg M/s Regal Pharmaceuticals,
dosage form)
Decision:
Brand Name +Dosage Form + Dep CR 25mg Tablet
Strength
Composition Each enteric film coated Tablet Contains:
Paroxetine…….…25mg
01-2019
Pharmacological Group Selective serotonin-reuptake inhibitors
Type of Form Form 5
Approval status of product in PAXIL CR of (USFDA approved)
Me-too status (with strength and Panox CR Tablet 25 mg M/s Regal Pharmaceuticals,
dosage form)
Decision:
Evaluator PEC-XII
Case. No. M/s Zamko Pharmaceuticals (Pvt) Ltd. Lahore. (New Licence)
The Central Licensing Board in its 267th meeting held on 31st December, 2018 has considered and approved the
grant of DML by the way of formulation of firm M/s Zamko Pharmaceuticals (Pvt) Ltd. 641-A Sundar
Industrial Estate, Lahore (DML:00890) as under:-
Sr. No Section No. of products No. of molecules
1 Tablet (General) Section 15 09

2 Capsule (General) Section - -
3 Oral powder suspension (General) Section 10 07
Tablet (General) Section
726. Name and Address of Manufacturer / M/s Zamko Pharmaceuticals (Pvt) Ltd.
Applicant 641-A Sundar Industrial Estate, Lahore
Brand Name + Dosage Form + Strength Zamlide 600mg Tablet
Diary No. Date of R & I & fee Form-5 Dy.No 3546 dated 24-01-2019 Rs.20,000/-
Dated 25-01-2019
Linezolid…600mg
Type of Form Form 5
Pack Size & Demanded Price 10’s /As per SRO
Approval Status of Product in Reference Zyvox film coated tablet 600mg. By Pharmacia and Up-
Regulatory Authorities. john. (USFDA Approved).
Me-too Status Nezolid Tablet of M/s Searl I.V. Lhr. (Reg. # 050325)
GMP Status 13-04-2018
Grant of DML
Panel recommends Grant of DML

Decision:
Brand Name + Dosage Form + Strength Zoxacin 250mg Tablet
Dated 25-01-2019
Ciprofloxacin (as hydrochloride) …250mg
Type of Form Form 5
Approval Status of Product in Reference Cipro 250mg Tablet by M/s Bayer Health Care
Regulatory Authorities. Pharmaceuticals
Inc.USA & Germany (USFDA Approved)
Me-too Status Mercip 250mg tablet by M/s Merck (Reg#024601)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Clicin 500mg Tablet
Dated 25-01-2019
Clarithromycin…500mg
Type of Form Form 5
Approval Status of Product in Reference Clarithromycin 500mg Film-coated Tablets by M/s
Regulatory Authorities. Ranbaxy (UK) Limited, (MHRA approved)
Me-too Status CLARION 500MG TABLET by M/s. 'Ferozsons Labs
(Reg#0002873)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Moxacin 400mg Tablet
Dated 25-01-2019
Moxifloxacin(as hydrochloride)…....400mg
Type of Form Form 5
Approval Status of Product in Reference Avelox 400 mg film-coated tablets by Bayer plc (MHRA
Me-too Status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zonac 50mg Tablet
Dated 25-01-2019
Composition Each enteric coated Tablet Contains:
Pharmacological Group Acetic acid derivatives and related substances
Type of Form Form 5
Approval Status of Product in Reference Diclofenac Sodium 50mg Gastro-Resistant Tablets by
Regulatory Authorities. M/s Dexcel®-Pharma Ltd (MHRA Approved)
Me-too Status Camotaren SR 50mg tablet by M/s MENDOZA
(Reg#012260)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zamkast 10mg Tablet
Dated 25-01-2019
Montelukast (as sodium) …10mg
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Pack Size & Demanded Price 10’s/As per SRO
Approval Status of Product in Reference Singulair tablets 10mg of M/s Merck Sharp & Dohme,
Regulatory Authorities. Australia (TGA Approved)
Me-too Status Montiget 10mg tablets of M/s Getz Pharma
(Reg. # 034838)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Clicin 250mg Tablet
Dated 25-01-2019
Composition Each film coated tablet contains: -
Pharmacological Group Macrolide antibiotic
Type of Form Form 5
Approval Status of Product in Reference Clarithromycin 250mg Film-coated Tablets by M/s
Regulatory Authorities. Ranbaxy (UK) Limited, (MHRA approved)
Me-too Status Pathocin Tablet 250mg by M/s Wilson Pharmaceuticals
(Reg#016724)
Grant of DML
Remarks of the Evaluator. .
Decision:
Brand Name + Dosage Form + Strength Zonac SR 100mg Tablet
Dated 25-01-2019
Composition Each sustained release Tablet Contains:
Pharmacological Group Acetic acid derivatives and related substances
Type of Form Form 5
Approval Status of Product in Reference Dicloflex Retard 100 mg by M/s Dexcel®-Pharma Ltd
Me-too Status Konac SR Tablets 100mg by M/s Remington
Pharmaceutical (Reg#020535)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zolor 10mg Tablet
Dated 25-01-2019
Composition Each film-coated Tablet Contains:
Loratadine…10mg
Pharmacological Group Other antihistamines for systemic use
Type of Form Form 5
Approval Status of Product in Reference Clarityn Allergy 10mg Tablets by M/s Bayer plc (MHRA
Me-too Status Senergy OD10mg tablet of M/s Highnoon (Reg.#017672)
Grant of DML
Remarks of the Evaluator.  Approved in MHRA and Netherland as uncoated
while is applied as film-coated.
Decision:
Brand Name + Dosage Form + Strength Zolocin 500mg Tablets
Dated 25-01-2019
Levofloxacin (as hemihydrate) …500mg
Type of Form Form 5
Approval Status of Product in Reference EVOXIL 500 MG FILM-COATED TABLETS by
Regulatory Authorities. Beacon Pharmaceutical (MHRA Approved)
Me-too Status Lefloxid tablet 500mg by M/s Wnsfield Pharma
(Reg#046819)
Grant of DML
Decision:
Decision:
Brand Name + Dosage Form + Strength Zamkast 4mg Chewable Tablet
Dated 25-01-2019
Composition Each chewable tablet contains;
Montelukast (as sodium).....4mg
Type of Form Form 5
Approval Status of Product in Reference Singulair 4mg chewable tablet by M/s Merck Sharp &
Regulatory Authorities. Dohme Corp, USFDA approved
Me-too Status Exma 4mg chewable tablet by M/s Asian Continental
(Reg#081007)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zambin 500mcg Tablet
Dated 25-01-2019
Composition Each film Coated Tablet Contains:
Mecobalamin…500mcg
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of Form Form 5
Pack Size & Demanded Price 10x10’s /As per SRO
Approval Status of Product in Reference Methicobide tablet 500 mcg sugar-coated, by Daito
Regulatory Authorities. Corporation. Approved by PMDA Japan
Me-too Status Elgin 500 mcg tablet of M/s Novartis Pharma (Pvt)
Limited (Reg. # 032638)
Grant of DML
Remarks of the Evaluator.  Firm has applied as film coated tablet whereas
formulation approved in PMDA is sugar coated.
Decision:
Brand Name + Dosage Form + Strength Zoxacin 500mg Tablet
Dated 25-01-2019
Type of Form Form 5
Approval Status of Product in Reference Cipro 500mg Tablet by M/s Bayer Health Care
Regulatory Authorities. Pharmaceuticals Inc.USA & Germany (USFDA
Approved)
Me-too Status Mercip 500mg Tablet by M/s Merck (Reg#024602)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zolocin 250mg Tablet
Dated 25-01-2019
Type of Form Form 5
Approval Status of Product in Reference EVOXIL 250 MG FILM-COATED TABLETS by
Regulatory Authorities. Beacon Pharmaceutical (MHRA Approved)
Me-too Status Cravit Tablets 250mg by M/s Hilton (Reg#022245)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zamkast 5mg Chewable Tablet
Dated 25-01-2019
Composition Each chewable tablet contains:
Montelukast (as sodium)…5mg
Type of Form Form 5
Approval Status of Product in Reference Singulair 5mg chewable tablet by M/s Merck Sharp &
Regulatory Authorities. Dohme Corp, USFDA approved
Me-too Status NenKast 5mg chewable tablet by M/s Nenza
Grant of DML
Decision:
Oral powder suspension (General) Section
Brand Name + Dosage Form + Strength Zoxacin 250mg/5ml Dry Suspension
Dated 25-01-2019
Ciprofloxacin (TM micro pellets 35%) …250mg
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form 5
Pack Size & Demanded Price 60ml /As per SRO
Approval Status of Product in Reference Ciproxin 250 mg/5 ml granules and solvent for oral
Regulatory Authorities. suspension by M/s Bayer Healthcare, MHRA approved.
Me-too Status Hiflox Dry suspension 250mg/5ml by M/s Hilton
(Reg#067499)
Grant of DML
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuticals, Islamabad.
Decision:
Brand Name + Dosage Form + Strength Zoxacin 125mg/5ml Dry Suspension
Dated 25-01-2019
Ciprofloxacin (TM micro pellets 35%) …125mg
Pharmacological Group Fluoroquinolone antibiotic
Type of Form Form 5
Approval Status of Product in Reference Not confirmed
(Reg#067498)
Grant of DML
Remarks of the Evaluator.  Registration Board in its 269th meeting decided as
follows:
Keeping in view the following statement written in

Qualitative and quantitative composition “2.5 mL
suspension after reconstitution (1/2 measuring spoon)
contains 125 mg ciprofloxacin” and domestic conditions
for difficulties in dispensing 250mg/5ml suspension for
children under 2 years of age, Registration Board decided
to approve the formulation of ciprofloxacin 125mg/5ml
granules and solvent for oral suspension as per reference
product approved by USFDA and MHRA
 Source of pellets: Vision Pharmaceuticals, Islamabad.
Decision:
Brand Name + Dosage Form + Strength Zamlide 100mg/5ml Dry Powder Suspension
Dated 25-01-2019
Linezolid…100mg
Type of Form Form 5
Approval Status of Product in Reference Linezolid 100 mg/5 ml granules for oral suspension by
Regulatory Authorities. Pfizer. (MHRA Approved)
Me-too Status Nezolid 100mg Suspension of Searle Pak, Karachi
(Reg. # 050326)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Mycin 250mg/5ml Dry Suspension
Dated 25-01-2019
Fosfomycin Calcium…250mg
Type of Form Form 5
Approval Status of Product in Reference FOSFOCINA Suspension 250mg/5ml by M/s
Regulatory Authorities. LABORATORIOS ERN, S.A. Barcelona, España (Spain
Approved)
Me-too Status Fosfonex 250mg/5ml Suspension of M/s Nexus Pharma
(Reg#075836)
Grant of DML
Remarks of the Evaluator.  Firm has applied as Fosfomycin Calcium…250mg,
whereas, formulation approved in Spain is
Decision:
Brand Name + Dosage Form + Strength Zolocin 125mg/5ml Dry Suspension
Dated 25-01-2019
Pharmacological Group Quinolone antibacterials
Type of Form Form 5
Approval Status of Product in Reference Could not be confirmed
Me-too Status Could not be confirmed
Grant of DML
Remarks of the Evaluator.  Evidence of approval of applied formulation in
reference regulatory authorities which were approved
by Registration Board in its 275th meeting is
required.
 Evidence of applied formulation/drug already
alongwith registration number, brand name and name
of firm is required.
Decision:
Brand Name + Dosage Form + Strength Zithro 200mg/5ml Suspension
Dated 25-01-2019
Azithromycin (as dihydrate) …200mg
Pharmacological Group Macrolide
Type of Form Form-5
Pack Size & Demanded Price 30ml/As per SRO
Approval Status of Product in Reference Zithromax 200mg/ 5ml powder for oral suspension of
Regulatory Authorities. M/s Pfizer Limited (MHRA Approved)
Me-too Status Azomax 200mg oral suspension of M/s Novartis Pharma,
Pakistan (Reg. # 022201)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zamadin 40mg/5ml Dry Powder Suspension
Dated 25-01-2019
Famotidine…40mg
Pharmacological Group Drugs for peptic ulcer and gastro-oesophageal reflux
disease (GORD) (H2-receptor antagonists)
Type of Form Form 5
Approval Status of Product in Reference Pepcid 40mg/5ml for oral suspension 40mg/5ml by M/s
Regulatory Authorities. Salix Pharma, (USFDA Approved)
Me-too Status Zepcin Dry Suspension 40mg/5ml by M/s Cirin
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Clicin 125mg/5ml Suspension
Dated 25-01-2019
Clarithromycin (as EC taste masked granules
27.5%)…125mg
Type of Form Form 5
Pack Size & Demanded Price 30ml, 60ml/As per SRO
Approval Status of Product in Reference Biaxin granules for oral suspension 125mg/5ml by M/s
Regulatory Authorities. Abbvie, USFDA approved.
Me-too Status Claritek Dry Suspension 125mg/5ml by M/s Getz Pharma
(Reg#009846)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Clicin 250mg/5ml Suspension
Dated 25-01-2019
27.5%)…250mg
Type of Form Form 5
Pack Size & Demanded Price 30ml, 60ml/As per SRO
Regulatory Authorities. Abbvie,(USFDA approved.)
(Reg#061347)
Grant of DML
Decision:
Brand Name + Dosage Form + Strength Zolocin 250mg/5ml Dry Suspension
Dated 25-01-2019
Pharmacological Group Quinolone antibacterials
Type of Form Form 5
Approval Status of Product in Reference Could not be confirmed
Me-too Status Could not be confirmed
Grant of DML
reference regulatory authorities which were approved
by Registration Board in its 275th meeting is
required.
alongwith registration number, brand name and name
of firm is required.
Decision:
Evaluator PEC-VIII
751. Name and Address of Manufacturer / M/s Zamko Pharmaceuticals (Pvt.) Ltd.,
Applicant 641-A Sundar Industrial Estate, Lahore.
Brand Name + Dosage Form + ZAMZOLE 20mg capsules
Strength
Diary No. Date of R & I & fee Each capsule contains:
Esomeprazole (as magnesium trihydrate)… 20mg
(As enteric coated pellets)
Source of pellets: M/s Vision Pharma Islamabad.
Composition Dy No. 3518; 25-01-2019; Rs.20,000/-
Type of Form Form-5
Pack Size & Demanded Price 14’s;As fixed by government
Approval Status of Product in Approved by MHRA
Me-too Status BS-Zole Capsule 20mg of M/s. Berlex Lab International
GMP Status Letter Issuance Date : 8th January, 2019
Decision:
Brand Name + Dosage Form + ZAMZOLE 40mg capsules
Strength
Esomeprazole (as magnesium trihydrate)… 40mg
(As enteric coated pellets)
Composition Dy No. 3514;25-01-2019; Rs.20,000/-
Type of Form Form-5
Pack Size & Demanded Price 14’s; As fixed by government
Me-too Status BS-Zole Capsule 40mg of M/s. Berlex Lab International
Decision:
Brand Name + Dosage Form + ZAMPROLE 20mg capsules
Strength
Omeprazole….20mg
(enteric coated pellets)
Type of Form Form-5
Pack Size & Demanded Price As fixed by government
Me-too Status Jumep -20 Capsule of M/s Jupiter Pharma
Decision:
754. Name and address of manufacturer / M/s Zamko Pharmaceuticals (Pvt.) Ltd.,
Brand Name +Dosage Form + ZAMPROLE 40mg capsules
Strength
Omeprazole….40mg
(enteric coated pellets)
Type of Form Form-5
Pack size & Demanded Price As fixed by government
Approval status of product in Approved by MHRA
Me-too status Jumep -40 Capsule of M/s Jupiter Pharma
GMP status Letter Issuance Date : 8th January, 2019
Decision:
Brand Name +Dosage Form + ZAMPHENE Capsule 50mg
Strength
Diary No. Date of R& I & fee Dy No. 3526;25-01-2019; Rs.20,000/-
Clomiphene citrate……..50mg
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form 5
Pack size & Demanded Price 10’s, 30’s: As per SRO
Approval status of product in Approved in MHRA(as provided by the firm)
Reference Regulatory Authorities. Clomid 50mg Tablets by M/s Sanofi
Me-too status Prolifin Capsule 50mg (Reg#010250)Of Chiesi
Pharmaceuticals (as provided by the firm)
275th meeting.
 Evidence of applied formulation/drug already approved
Decision:
Brand Name +Dosage Form + ZAMBLIN 300mg Capsule
Strength
Pregabalin……………300mg
Type of Form Form-5
Me-too status Gabica 300mg Capsule of Getz Pharma
Remarks of the Evaluator. Monograph for test/analysis of Applied formulation is not
present in USP.
Decision:
Brand Name+ Dosage Form + ZAMBLIN 150mg Capsule
Strength
Diary No. Date of R & I & fee Dy No. 3510;25-01-2019; Rs.20,000/-
Pregabalin……………150mg
Type of Form Form-5
Approval Status of Product in Pregabalin 150mg Hard capsules Accord Healthcare Limited
Reference Regulatory Authorities. United Kingdom, Hungary.
Me-too Status Gabica150mg Capsule of Getz Pharma

present in USP.
Decision:
Brand Name + Dosage Form + ZAMBLIN 100mg Capsule
Strength
Pregabalin…………….100mg
Type of Form Form-5
Approval Status of Product in Pregabalin 100mg Hard capsules Accord Healthcare
Reference Regulatory Authorities. Limited
United Kingdom, Hungary.
Me-too Status Gabica100mg Capsule of Getz Pharma
present in USP.
Decision:
Strength
Pregabalin………….75mg
Type of Form Form-5
Me-too Status Gabica 75mg Capsule of Getz Pharma
present in USP.
Decision:
Strength
Pregabalin…………………….50mg
Type of Form Form-5
Me-too Status Gabica 50mg Capsule of Getz Pharma
present in USP.
Decision:
Brand Name + Dosage Form + ZAFLAM 75mg SR Capsule
Strength
Diclofenac sodium………….75mg
(as sustained release pellets)
Source of pellets: M/s Vision Phrma Islamabad.
Type of Form Form-5
Approval Status of Product in Diclomax SR Capsules 75mg;United Kingdom, Itlay (as
Reference Regulatory Authorities. provided by the firm)
Me-too Status Dicloyan-S Roryan Pharmaceutical Industries (Pvt) Ltd

Pakistan.
275th meeting as the provided evidence is not
verifiable.
Decision:
Brand Name + Dosage Form + ZAFLAM RETARD 100mg Capsule
Strength
Diclofenac sodium ……………….100mg
(as sustained release pellets)
Source of pellets: M/s Vision Phrma Islamabad.
Type of Form Form-5
Approval Status of Product in Diclomax Retard Capsules 100mg;United Kingdom, Itlay
Reference Regulatory Authorities. (as provided by the firm)
Me-too Status Dicloyan-S Roryan Pharmaceutical Industries (Pvt) Ltd
Pakistan.
were declared/approved by the Registration Board
in its 275th meeting as the provided evidence is not
verifiable.
Decision:
Brand Name +Dosage Form + Strength MYCIN Capsule 500mg
Composition Each Hard Capsule contains:
Fosfomycin calcium.......................500mg
Type of Form Form 5
Finished Product Specification Ph,Eur
Approval status of product in Approved in Spain
Reference Regulatory Authorities. FOSFOSINA 500mg Hard capsules; SPAIN
Me-too status Osfocin Capsule 500mg of Krka Pak, Karachi
in its 275th meeting as the provided evidence is
not verifiable.
Decision:
Brand Name +Dosage Form + Strength ZAMITRA Capsule 100mg
Itraconazole..................100mg
(Immediate ReleasePellets)
Type of Form Form 5
Me-too status Traconol Capsule 100mg of Fozan Pharmaceuticals
Decision:
Brand Name +Dosage Form + ZITHRO Capsule 250mg
Strength
Azithromycin (as dihydrate).............250mg
Pharmacological Group Antibiotic(Macrolide)
Type of Form Farm 5
Me-too status Azomaxof Novartis Pharma
Decision:
Brand Name +Dosage Form + ZAMCON Capsule 150mg
Strength
Fluconazole.........................150mg
Type of Form Farm 5
Pack size & Demanded Price 1’s : as per SRO
Me-too status Trac Capsules 150mg of Fozan Pharmaceuticals
Brand Name + Dosage Form + ZAMPRID OD Capsule 150 mg
Strength
Diary No. Date of R & I & fee Each Hard Capsule Contains:
Itopride Hydrochloride …150mg
(sustained release pellets)
Composition Dy. No. 3547;25-01-2019; Rs.20,000/-
Pharmacological Group Prokinetic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack Size & Demanded Price 14’s, 30’s; as per SRO
Approval Status of Product in Ganaton OD of M/s Abbott Laboratories (PMDA) India
Reference Regulatory Authorities. Approved
Me-too Status NOGERD by Helix Pharma(Reg#067043)
275th meeting as provided evidence is of India which
is not one among the reference agencies.
b. New/Additional section(s)
Evaluator PEC-III
M/s Caliph Pharma, Risalpur
Firm was granted 2 new/ additional section vide letter by secretary Licensing Board through letter No.
F.3-6/2005-Lic (Vol-I) dated 17-01-2019. According to the letter CLB in its 267th meeting has approved
following sections, for which the firm has applied for products as under:
Section No. of molecules applied No. of products applied

Cream/ointment/Lotion section 10 18
(General)
Sachet Section (General) 10 11
Cream/ointment/Lotion section (General): Molecules-10/ Products-18

768. Name and address of manufacturer / M/s Caliph Pharmaceuticals Pvt Ltd. Plot # 17,
Brand Name +Dosage Form + Strength Ketocal 2% w/w Lotion
Composition Each Gram of Lotion Contains:
Ketoconazole…20mg (2% w/w)
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Antifungals for topical use
Type of Form Form 5
Approval status of product in Reference Dandrazol 2% w/w topical solution by Transdermal
Me-too status Ketonaz lotion by Sante (Reg#073453)
GMP status Panel inspection report dated 6-11-2018 recommended
renewal of DML and grant of 2 additional sections.
Decision:
Brand Name +Dosage Form + Strength Ketocal 2% w/w Cream
Composition Each Gram Contains:
Rs.20,000/- Dated 04-02-2019
Type of Form Form 5
Approval status of product in Reference Nizoral 2% w/w cream by Janssen
Me-too status Ketoval cream by Valor Pharma (Reg#027868)
Decision:
Brand Name +Dosage Form + Strength Tacrocal 0.1% w/w Ointment
Tacrolimus as Monohydrate…1mg (0.1% w/w)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Finished Product Specification Innovator’s specification
Approval status of product in Reference Protopic 0.1% w/w ointment by LEO Pharma
Me-too status Eczemus 0.1% ointment by Brookes (Reg#045493)
Decision:
Brand Name +Dosage Form + Strength Tacrocal 0.03% w/w Ointment
Tacrolimus as Monohydrate…0.3mg (0.03% w/w)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Protopic 0.03% w/w ointment by LEO Pharma
Me-too status Eczemus 0.03% ointment by Brookes (Reg#045494)
Decision:
Brand Name +Dosage Form + Strength Minoxical 5% w/v Lotion
Composition Each ml of lotion Contains:
Minoxidil…50mg (5% w/v)
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Other dermatologicals
Type of Form Form 5
Approval status of product in Reference Regaine for men extra strength 5% w/v topical
Regulatory Authorities. solution by McNeil (MHRA Approved)
Me-too status Minoxin Plus lotion by Brookes Pharma (Reg#034492)
Decision:
Brand Name +Dosage Form + Strength Clobetacal Ointment 0.05% w/w
Clobetasol Propionate…0.5mg (0.05% w/w)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference ClobaDerm 500mcg/g ointment by Auden
Me-too status Cobi-scot ointment by Scotmann (Reg#037761)
Decision:
Brand Name +Dosage Form + Strength Clobetacal 0.05% w/w Cream
Clobetasol Propionate…0.5mg (0.05% w/w)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference ClobaDerm 500mcg/g cream by Auden
Me-too status Dermit Cream 0.05% w/w by Fynk Pharma
(Reg#080078)
Decision:
Brand Name +Dosage Form + Strength Mometacal 0.1% w/w Ointment
Mometasone Furoate…1mg (0.1% w/w)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Elocon 0.1% w/w ointment by Merck
Me-too status Momate 0.1% ointment by Maxitech (Reg#083745)
Decision:
Brand Name +Dosage Form + Strength Mometacal 0.1% w/w Lotion
Composition Each Gram of lotion Contains:
Mometasone Furoate…1mg (0.1% w/w)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Elocon 0.1% w/w scalp lotion by Merck
Me-too status Momate 0.1% lotion by Maxitech (Reg# 083744)
Decision:
Brand Name +Dosage Form + Strength Nixcal 5% w/w Lotion
Permethrin…50mg (5% w/w)
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Scabicides
Type of Form Form 5
Approval status of product in Reference Permethrin lotion 5% w/w by GSK
Me-too status Nedax plus lotion by Stiefel (Reg#037852)
Decision:
Brand Name +Dosage Form + Strength Nixcal 5% w/w Cream
Permethrin…50mg (5% w/w)
Rs.20,000/- Dated 04-02-2019
Pharmacological Group Scabicides
Type of Form Form 5
Approval status of product in Reference Permethrin 5% w/w cream by Sandoz
Me-too status Lotrix cream by GSK (Reg#010516)
Decision:
Brand Name +Dosage Form + Strength Clindacal 1% w/v Lotion
Clindamycin as Phosphate…10mg (1% w/v)
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Dalacin T 1%w/v Topical solution by Pfizer
Me-too status Dalacin T lotion by Pfizer (Reg#013582)
Decision:
Brand Name +Dosage Form + Strength Clindacal 2% w/w Vaginal Cream
Clindamycin as Phosphate…20mg (2% w/w)
Rs.20,000/- Dated 04-02-2019
Pharmacological Group Gynaecological anti-infectives and antiseptics
Type of Form Form 5
Approval status of product in Reference Dalacin Cream 2% w/w by Pfizer
Me-too status Dalacin V cream by Pfizer (Reg#018574)
Decision:
Brand Name +Dosage Form + Strength Diprocal-G Cream
Betamethasone as Dipropionate…0.5mg (0.05%w/w)
Gentamicin as sulphate…1mg (0.1%w/w)
Rs.20,000/- Dated 04-02-2019
Pharmacological Group Topical glucocorticoid along with aminoglycoside
antibiotic
Type of Form Form 5
Approval status of product in Reference Diprogenta cream by MSD
Regulatory Authorities. (Germany Approved)
Me-too status Effigenta Cream by Mass Pharma (Reg#024375)
Decision:
Brand Name +Dosage Form + Strength Diprocal-G Ointment
Betamethasone as Dipropionate…0.5mg (0.05% w/w)
Gentamicin as sulphate…1mg (0.1% w/w)
Rs.20,000/- Dated 04-02-2019
Pharmacological Group Topical glucocorticoid along with aminoglycoside
antibiotic
Type of Form Form 5
Approval status of product in Reference Diprogenta Ointment by MSD
Me-too status Effigenta ointment by Mass Pharma (Reg# 024376)
Decision:
Brand Name +Dosage Form + Strength Diprocal-S Ointment
Composition Each Gram Cont ains:
Betamethasone as Dipropionate…0.5mg
Salicyclic Acid…30mg
Rs.20,000/- Dated 04-02-2019
Pharmacological Group Corticosteroids combination with analgesic
Type of Form Form 5
Approval status of product in Reference Diprosalic 0.05% w/w / 3%w/w ointment by Merck
Me-too status Provate-S ointment by Reko Pharma (Reg#027190)
Decision:
Brand Name +Dosage Form + Strength Diprocal-S Lotion 0.05% w/w / 2%w/w
Betamethasone as Dipropionate…0.5mg
Salicyclic Acid…20mg
Rs.20,000/- Dated 04-02-2019
Pharmacological Group Corticosteroids combination with analgesic
Type of Form Form 5
Approval status of product in Reference Diprosalic Scalp application 0.05%w/w / 2%w/w
Regulatory Authorities. cutaneous solution by Merck UK (MHRA Approved)
Me-too status Provate-S Lotion by Saffron (Reg# 060354)
Decision:
th
| 365
Brand Name +Dosage Form + Strength Daktacal Cream 2% w/w / 1% w/w
Miconazole Nitrate…20mg
Hydrocortisone (as Acetate)…10mg
Rs.20,000/- Dated 04-02-201
Type of Form Form 5
Approval status of product in Reference Daktacort hydrocortisone cream (2%w/w / 1%w/w) by
Regulatory Authorities. McNeil Products (MHRA Approved)
Me-too status Albicost cream by Shrooq Pharma (Reg# 040842)
Decision:
Sachet Section (General): Molecules-10/ Products-11
Brand Name +Dosage Form + Strength Zegecal 20/1680 mg Sachet
Omeprazole…20mg
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Proton Pump Inhibitors
Type of Form Form 5
Approval status of product in Reference Zegerid Powder for oral suspension by Santaurus
Me-too status Risek Insta Sachet by Getz
Decision:
Brand Name +Dosage Form + Strength Zegecal 40/1680 mg Sachet
Omeprazole…40mg
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Proton Pump Inhibitors
Type of Form Form 5
Approval status of product in Reference Zegerid Powder for oral suspension by Santaurus
Me-too status Risek Insta Sachet by Getz
Decision:
Brand Name +Dosage Form + Strength Mucocal 200mg Sachet
Acetylcysteine…200mg
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Acetylcysteine 200mg powder for oral solution by
Regulatory Authorities. Colonis (MHRA Approved)
Me-too status Mucolator 200mg Sachet by Abbott (Reg#017693)
Decision:
Brand Name +Dosage Form + Strength Electrocal Sachet
Pre-Cooked Rice Powder…6gm
Sodium Citrate…0.580gm
Sodium Chloride…0.350gm
Potassium Chloride…0.300gm
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Electrolytes with carbohydrates
Type of Form Form 5
Approval status of product in Reference Dioralyte Relief Blackcurrant Sachets by Sanofi
Regulatory Authorities. Aventis (MHRA Approved)
Me-too status Peditral-R Sachet by Searle (Reg#076282)
Decision:
Brand Name +Dosage Form + Strength Hepa-Cal 3gm Sachet
L-Ornithine L-Aspartate…3gm
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Hepato-protective
Type of Form Form 5
Approval status of product in Reference Hepa-Merz 3g granules by Merz Pharma
Regulatory Authorities. (AGES Austria Approved)
Me-too status Couthy 3gm sachet by Martin Dow (Reg#070474)
Decision:
Brand Name +Dosage Form + Strength Stroncal 2g Sachet
Strontium Ranelate…2g
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Other drugs affecting bone structure and mineralization
Type of Form Form 5
Approval status of product in Reference Strontium ranelate Aristo 2g granules for oral
Regulatory Authorities. suspension by Aristo (MHRA Approved)
Me-too status Onita Sachet 2g by PharmEvo (Reg#057746)
Decision:
Brand Name +Dosage Form + Strength Ibucal 600mg Sachet
Ibuprofen…600mg
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Brufen granules by Mylan
Me-too status Hibufen 600mg Sachet by Hiranis (Reg#081554)
Decision:
Brand Name +Dosage Form + Strength Montecal 4mg Sachet
Montelukast as Sodium…4mg
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Singulair pediatric 4mg granules by Merck
Me-too status Singulair 4mg oral granules by Merck (Reg#031377)
Decision:
Brand Name +Dosage Form + Strength Mebecal 135mg/3.5g Sachet
Mebeverine hydrochloride…135mg
Ispaghula Husk…3.5g
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Antispasmodic / laxative
Type of Form Form 5
Approval status of product in Reference Fybogel Mebeverine granules for oral suspension in
Regulatory Authorities. unit sachet by Reckitt Benckiser (MHRA Approved)
Me-too status Mebipas sachet by Hilton Pharma (Reg#066844)
Decision:
Brand Name +Dosage Form + Strength Macrocal Sachet
Macrogol 3350…13.125g
Sodium Chloride…0.3507
Potassium Chloride…0.0466g
Sodium Bicarbonate…0.1785g
Rs.20,000/- Dated 30-01-2019
Pharmacological Group Osmotically active laxative
Type of Form Form 5
Approval status of product in Reference MOVICOL 13.8g sachet, powder for oral solution by
Regulatory Authorities. Norgine Ltd. (MHRA Approved)
Me-too status Marfinal Sachet 13.8gm by Martin Dow (Reg#080647)
Decision:
Brand Name +Dosage Form + Strength Fosfocal 3g Sachet
Fosfomycin as Trometamol…3g
Rs.20,000/- Dated 30-01-2019
Type of Form Form 5
Approval status of product in Reference Monuril 3g granules for oral solution by Zambon
Me-too status Uronol sachet 3g by Faas Pharma (Reg#083971)
Decision:
Evaluator PEC-IV
LIQUID INJECTION AMPOULE (GENERAL)

797. Name and address of M/s Berlex Lab International 10-Km Nagshah chowk
manufacturer / Applicant Karachi road Multan
Brand Name +Dosage Form + Amkan 100mg/2ml Injection
Strength
Composition Each Ampoule Contains:
Amikacin as Sulphate…….…100mg/2ml
Type of Form Form 5
Pack size & Demanded Price 1’s x 2ml;As per SRO
Approval status of product in Amikin Injection Of MHRA Approved
Me-too status (with strength and Nekrocin 100 Injection of M/s Safe Pharmaceuticals,
dosage form)
GMP status GMP & grant license inspection report conducted on
05-07-2018
Decision:
Strength
Type of Form Form 5
Approval status of product in Briklin 250mg/2ml by EMA
Me-too status (with strength and Aminocin 250mg Injection of M/s Macquins International,
dosage form)
05-07-2018
Decision:
Strength
Type of Form Form 5
Approval status of product in Amikacin Injection Of USFDA Approved
Me-too status (with strength and Dunkin 500mg Injection of M/s Amros Karachi .
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Cobalim 500mcg/ml Injection
Strength
Mecobalamin…….…500mcg
Pharmacological Group Co-enzyme-type vitamin B12
Type of Form Form 5
Approval status of product in PMDA approved
Me-too status (with strength and Wycomin 500 mcg Injection by Wnsfeild
dosage form) Pharmaceutical,
05-07-2018
Decision:
Brand Name +Dosage Form + Xofer 100mg/5ml Injection
Strength
Iron sucrose compex eq to elemental Iron…….…100mg
Pharmacological Group Iron replacement product
Type of Form Form 5
Approval status of product in Venofer 100mg/5ml Injection of MHRA approved
Me-too status (with strength and Bisleri 100mg/5ml Injection of M/S Sami Pharma
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Xocol 500mg/4ml Injection
Strength
Citicoline (as sodium)…….…500mg
Pharmacological Group Psychostimulants, Agents Used For ADHD And
Nootropics (Other psychostimulants and nootropics)
Type of Form Form 5
Approval status of product in ITICOLINE PANPHARMA 500 mg/ 4ml, solution
Reference Regulatory Authorities injectable (IM,IV) ampoule by M/s PANPHARMA
(ANSM, France Approved)
Me-too status (with strength and SOMAZINA INJECTION 500mg/4ml by Alina pharma
dosage form) (Reg.No. 016975)
05-07-2018
Decision:
Brand Name +Dosage Form + Xocol 250mg/2ml Injection
Strength
Citicoline (as sodium)…….…250mg
Pharmacological Group Psychostimulants, Agents Used For ADHD And
Nootropics (Other psychostimulants and nootropics)
Type of Form Form 5
Approval status of product in ITICOLINE PANPHARMA 500 mg/ 4ml, solution
Reference Regulatory Authorities injectable (IM,IV) ampoule by M/s PANPHARMA
(ANSM, France Approved)
Me-too status (with strength and Neurotec Injection. 250mg/2ml by M/s Schazoo
dosage form) Laboratories,
05-07-2018
Decision:
Brand Name +Dosage Form + Tritamol 100mg/2ml Injection
Strength
Tramadol HCl…….…250mg
Type of Form Form 5
Approval status of product in Zydol Injection of MHRA approved
Me-too status (with strength and Tramed 100mg Injection by M/s Cirin Pharmaceuticals,,
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Ketarax 10mg/ml Injection
Strength
Ketorolac Tromethamine…….…10mg
Type of Form Form 5
Approval status of product in Toradol 10mg/ml of TGA approved
Me-too status (with strength and Ketopan Injection 30mg by M/s Welwrd Pharmaceuticals,
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Ketarax 30mg/ml Injection
Strength
Ketorolac Tromethamine…….…30mg
Type of Form Form 5
Approval status of product in Toradol 30mg/ml of TGA approved
Me-too status (with strength and Ketopan Injection 30mg by M/s Welwrd Pharmaceuticals,
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Ketam 500mg/10ml Injection
Strength
Ketamine HCl…….…500mg/10ml
Pharmacological Group General Anesthesia
Type of Form Form 5
Approval status of product in Ketalar 50 Mg/Ml Injection, of MHRA approved
Me-too status (with strength and Misket 50mg/ml Injection by M/s Mission
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Ketam 100mg/2ml Injection
Strength
Ketamine HCl…….…100mg/2ml
Pharmacological Group General Anesthesic
Type of Form Form 5
Approval status of product in Ketalar 50 Mg/Ml Injection, of MHRA approved
Me-too status (with strength and Misket 50mg/ml Injection by M/s Mission
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Diclotal 2ml Injection
Strength
Diclofenac sodium…….…75mg
Lidocaine HCl…….20mg
Pharmacological Group NSAID & Local Anesthesia
Type of Form Form 5
Approval status of product in Diclofenac-Mepha 75 ampoules, of Mepha pharma
Reference Regulatory Authorities AG approved by switerzerland
Me-too status (with strength and Difam Plus Injection by M/s Bosch
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Xovit 5mg/ml Injection
Strength
Cholecalciferol…….…5mg
Type of Form Form 5
Approval status of product in Vitamin D3 Good 5mg/ 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)
05-07-2018
Decision:
Brand Name +Dosage Form + Xalbuphine 10mg/ml Injection
Strength
Composition Each ml Ampoule Contains:
Nalbuphine as hydrochloride…….10mg
Pharmacological Group Opioid Analgesic
Type of Form Form 5
Finished product Specifications Manufacturer
Approval status of product in Nubain Injection 10mg/ml of Health Canada
Me-too status (with strength and Nalfy Injection 10mg by M/s. Vision Pharmaceuticals,
dosage form)
05-07-2018
Decision:
Brand Name +Dosage Form + Xalbuphine 20mg/ml Injection
Strength
Composition Each ml Ampoule Contains:
Nalbuphine as hydrochloride…….20mg
Pharmacological Group Opioid Analgesic
Type of Form Form 5
Finished product Specifications Manufacturer
Approval status of product in Nubain Injection 20mg/ml of Health Canada
Me-too status (with strength and Nalfy Injection 20mg by M/s. Vision Pharmaceuticals,
dosage form)
05-07-2018
Decision:
Evaluator PEC-XII
Case. No..M/s Rotex Pharma (Pvt) Ltd, Islamabad. (New Section)
The Central Licensing Board in its 266th meeting held on 24th Oct, 2018 has considered and approved the grant of
15 additional section of firm M/s Rotex Pharma (Pvt) Ltd.,Plot No. 206 & 207. Industrial Triangle, Kahuta Road,
Islamabad (DML:000651) as under:-
1 Cream/ ointment (General) 10 11

2 Topical (Steroid section) 09 10
3 Oral Dry Suspension (General) 10 12
Cream/ ointment (General)
11 Products/ 10 Molecule
813. Name and Address of Manufacturer / M/s Rotex Pharma (Pvt) Ltd.,
Applicant Plot No. 206 & 207. Industrial Triangle, Kahuta Road,
Islamabad
Brand Name + Dosage Form + Strength Racto 0.03%w/w Ointment
Diary No. Date of R & I & fee Form-5 Dy.No 41127 dated 06-12-2018 Rs.20,000/- Dated
06-12-2018
Pharmacological Group Agent for dermatitis excluding corticosteroids
Type of Form Form 5
Pack Size & Demanded Price 10g , 30g/ As per SRO
Approval Status of Product in Reference PROTOPIC (tacrolimus) Ointment 0.03%w/w by M/s LEO
Regulatory Authorities. PHARMA AS (USFDA Approved)
Me-too Status Prolimus ointment 0.03% of M/s Kaizen Pharma
(Reg.#073752)
Grant of Additional sections
Panel Recommended grant of additional sections
Decision:
Islamabad
Brand Name + Dosage Form + Strength Racto 0.1%w/w Ointment
06-12-2018
Tacrolimus (as monohydrate)…1mg (0.1%w/w)
Pharmacological Group Agent for dermatitis excluding corticosteroids
Type of Form Form 5
Pack Size & Demanded Price 10g , 30g/ As per SRO
Approval Status of Product in Reference PROTOPIC (tacrolimus) Ointment 0.1%w/w by M/s LEO
Regulatory Authorities. PHARMA AS (USFDA Approved)
Me-too Status Aimus ointment of M/s Aims Pharmaceuticals (Reg.#
069939)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Rocim 2%w/w Ointment
06-12-2018
Mupirocin …20mg (2%w/w)
Pharmacological Group Other antibiotics for topical use
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g,15g, 30g/ As per SRO
Approval Status of Product in Reference Bactroban 2% Ointment by M/s GlaxoSmithKline (MHRA
Me-too Status Bactroban 2% Ointment by M/s GlaxoSmithKline
(Reg#010399)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Reson 0.05% Cream
07-12-2018
Isotretinoin…0.5mg (0.05%w/w)
Pharmacological Group Retinoids for treatment of acne
Type of Form Form 5
Pack Size & Demanded Price 10g / As per SRO
Approval Status of Product in Reference Isotrex 0.05% Cream by GSK
Me-too Status Acnecid Cream by M/s Reko Pharmacal (Reg.#024688)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Citex 0.005% Cream
07-12-2018
Calcipotriol (as monohydrate) …0.05mg (0.005%w/w)
Pharmacological Group Other antipsoriatics for topical use
Type of Form Form 5
Pack Size & Demanded Price 30g/ As per SRO
Approval Status of Product in Reference Calcipotriol Cream 50 micrograms/g by M/s Sandoz
Me-too Status Calcipot Cream 0.005% by M/s Valor Pharmaceuticals
(Reg#069823)
Decision:
Islamabad
Brand Name + Dosage Form + Strength C-Zole-V 1%w/w Cream
07-12-2018
Composition Each gm of cream contains:
Clotrimazole ……..10mg (1% w/w)
Pharmacological Group Azole Antifungal
Type of Form Form 5
Pack Size & Demanded Price 10g,15g, 20g, 35g/ As per SRO
Approval Status of Product in Reference Clotrimazole 1% w/w Cream by M/s Teva UK Limited
Regulatory Authorities. (MHRA approved)
Me-too Status Dermofit 1% Cream by M/s Baxter (Reg#073438)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Flor-H 13.9%w/w Cream
07-12-2018
Eflornithine hydrochloride (as monohydrate) …139mg
(13.9%w/w)
Pharmacological Group Other agents against leishmaniasis and trypanosomiasis
Type of Form Form 5
Pack Size & Demanded Price 15g, 30g/ As per SRO
Approval Status of Product in Reference VANIQA (eflornithine hydrochloride) Cream, 13.9% by
Regulatory Authorities. M/s Bristol-Myers Squibb Company (USFDA Approved)
Me-too Status Vaniflor Cream 13.9% by M/s Highnoon (Reg.#071575)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Plane 0.1%w/w Cream
07-12-2018
Adapalene…1mg (0.1%w/w)
Pharmacological Group Retinoids for topical use in acne
Type of Form Form 5
Approval Status of Product in Reference Differin 0.1% w/w Cream by M/s Galderma (UK) Limited
Me-too Status Elucider Cream 0.1% by M/s Hoover Pharmaceuticals
(Reg.#062458)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Terfugal 1%w/w Cream
07-12-2018
Terbinafine hydrochloride…10mg (1%w/w)
Pharmacological Group Other antifungals for topical use
Type of Form Form 5
Pack Size & Demanded Price 10g,15g, 30g/ As per SRO
Approval Status of Product in Reference LAMISIL 1% w/w Cream by M/s GlaxoSmithKline
Regulatory Authorities. Consumer Healthcare (UK) Trading Limited (MHRA
Approved)
Me-too Status Lamisil Cream 1% by M/s Sandoz (Reg.#)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Fast 2% Cream
06-12-2018
Fusidic Acid…20mg (2%w/w)
Type of Form Form 5
Pack Size & Demanded Price 5g,15g / As per SRO
Approval Status of Product in Reference Fucidin 20 mg/g Cream by M/s LEO Laboratories Limited
Me-too Status FUCIDIN CREAM by M/s Leo (Reg.#015539)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Citop 0.005% Ointment
06-12-2018
Calcipotriol …0.05mg (0.005%w/w)
Pharmacological Group Other antipsoriatics for topical use
Type of Form Form 5
Approval Status of Product in Reference Dovonex Ointment by M/s LEO Laboratories Ltd (MHRA
Me-too Status DAIVONEX OINTMENT 0.005% by M/s ZAM ZAM
CORP (Reg#015726)
Decision:
Topical (Steroid section)
824. Name and Address of Manufacturer / Applicant M/s Rotex Pharma (Pvt) Ltd.,
Plot No. 206 & 207. Industrial Triangle, Kahuta Road,
Islamabad
Brand Name + Dosage Form + Strength Flunone Cream
Dated 06-12-2018
Fluocinolone acetonide…0.1mg (0.01%w/w)
Hydroquinone…40mg (4%w/w)
Tretinoin…0.5mg (0.05%w/w)
Pharmacological Group Corticosteroid+ melanin synthesis inhibitor+retinoid
Type of Form Form 5
Pack Size & Demanded Price 10g,15g, 30g/ As per SRO
Approval Status of Product in Reference TRI-LUMA Cream 0.01%/4%/0.05% by M/s
Regulatory Authorities. GALDERMA laboratories, L.P (USFDA Approved)
Me-too Status Trimelasin Cream by M/s Valor Pharmaceuticals
(Reg#031104)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Betacal Ointment
Dated 06-12-2018
Calcipotriol (as monohydrate) …0.05mg (0.005%w/w)
Betamethasone (as dipropionate)…0.5mg (0.05%w/w)
Pharmacological Group Anti-psoriatic
Type of Form Form 5
Approval Status of Product in Reference Dalbecal 50 microgram/ g + 0.5 mg/ g Ointment by M/s
Me-too Status Daivobet Ointment by M/s Zam Zam corporation (Reg #
031379)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Fubasome Cream
Dated 06-12-2018
Betamethasone (as valerate) …1mg (0.1%w/w)
Pharmacological Group Corticosteroids, potent, combinations with antibiotics
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g,15g,/ As per SRO
Approval Status of Product in Reference Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream by
Regulatory Authorities. M/s Goapharma (MHRA Approved)
Me-too Status Fucicort Leo Cream by M/s Leo Pharma (Reg.#012803)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Presol 0.1%w/w Cream
Dated 07-12-2018
Methylprednisolone aceponate…1mg
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g / As per SRO
Approval Status of Product in Reference ADVANTAN methylprednisolone aceponate 1mg/g
Regulatory Authorities. cream by M/s Bayer Australia Ltd (TGA Approved)
Me-too Status Advantan 0.1% w/w cream by M/s Bayer Health Care
(Reg#018644)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Beta-One Cream
07-12-2018
Betamethasone (as dipropionate) …0.5mg (0.05%w/w)
Clotrimazole…10mg (1%w/w)
Pharmacological Group Corticosteroids and antiinfectives in combination
Type of Form Form 5
Pack Size & Demanded Price 10g, 15g, 30g/ As per SRO
Approval Status of Product in Reference Lotriderm Cream by M/s Expono Ltd (MHRA Approved)
Me-too Status Lotriderm -B Cream by M/s Hoover Pharmaceuticals
(Reg.#064534)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Beta-Gen Cream
07-12-2018
Betamethasone (as dipropionate)…0.5mg (0.05%w/w)
Gentamicin (as sulphate) …1mg (0.1%w/w)
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g,15g,/ As per SRO
Approval Status of Product in Reference Diprogenta Cream by Beragena Arzneimittel GmbH
Me-too Status Effigenta Cream by Mass Pharma (Reg.#024375)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Hydrozole 1% Cream
07-12-2018
Clotrimazole…10mg (1% w/w)
Hydrocortisone (as acetate)… 10mg (1% w/w)
Type of Form Form 5
Pack Size & Demanded Price 10g, 20g / As per SRO
Approval Status of Product in Reference Canesten HC Cream by M/s Bayer plc (MHRA Approved)
Me-too Status Hydrozole Cream by M/s Stiefel Laboratories Pakistan
(Pvt) Ltd (Reg#029329)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Beta-Gen Ointment
07-12-2018
Betamethasone (as dipropionate)…..0.5mg (0.05% w/w)
Gentamicin (as sulphate)……..1mg (0.1% w/w)
Pharmacological Group Corticosteroids, potent, combinations with antibiotics
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g,15g, 30g/ As per SRO
Approval Status of Product in Reference Diprogenta Ointment by M/s MSD (Germany Approved)
Me-too Status Effigenta Ointment by M/s Mass Pharma (Reg.#024376)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Tesol 0.05%w/w Ointment
07-12-2018
Clobetasol (as propionate) …0.5mg (0.05%w/w)
Pharmacological Group Corticosteroids, very potent (group IV)
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g,15g/ As per SRO
Approval Status of Product in Reference Clobetasol Propionate 0.05% w/w Ointment by M/s
Regulatory Authorities. Accord Healthcare Limited (MHRA Approved)
Me-too Status Clobevate Ointment 0.05% by M/s Stiefel Laboratories
(Re#029330)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Fudrosone Cream
06-12-2018
Hydrocortisone Acetate…10mg (1%w/w)
Pharmacological Group Corticosteroids, weak, combinations with antibiotics
Type of Form Form 5
Pack Size & Demanded Price 5g, 10g,15g/ As per SRO
Approval Status of Product in Reference Fucidin H Cream by M/s LEO Laboratories Limited
Me-too Status Fucidin H Cream by M/s Leo Pharmaceutical Products
(Reg.#023123)
Decision:
Oral Dry Suspension (General)
Islamabad
Brand Name + Dosage Form + Strength Texklar 125mg/5ml Dry Suspension
05-12-2018
Composition Each 5 ml after reconstitution contains:
27.5%)…125mg
Type of Form Form 5
Pack Size & Demanded Price 60ml / As per SRO
Regulatory Authorities. Abbvie, (USFDA approved.)
(Reg#009846)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Fortycin 250mg/5ml Dry Suspension
05-12-2018
Fosfomycin Calcium Eq. to Fosfomycin…250mg
Type of Form Form 5
Pack Size & Demanded Price 60ml/ As per SRO
Approval Status of Product in Reference FOSFOCINA SUSPENSIÓN 250mg/ml by M/s
Regulatory Authorities. LABORATORIOS ERN, S.A. (Approved by
Spanish Agency of Medicines and Health Products)
Me-too Status Focin Suspension 250mg/5ml by M/s Tabros Pharma
(Reg.#015946)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Volvic 40mg/5ml Dry Suspension
05-12-2018
Composition Each 5 ml after reconstitution contains: -
Famotidine …40mg
Pharmacological Group Drugs for peptic ulcer and gastro-oesophageal reflux
disease (GORD) (H2-receptor antagonists)
Type of Form Form 5
Approval Status of Product in Reference Pepcid 40mg/5ml for oral suspension 40mg/5ml by M/s
Regulatory Authorities. Salix Pharma, (USFDA Approved)
Me-too Status Zepcin Dry Suspension 40mg/5ml by M/s Cirin
Decision:
Islamabad
Brand Name + Dosage Form + Strength Fluzol 50mg/5ml Dry Suspension
05-12-2018
Composition Each 5ml of reconstituted suspension contains:
Fluconazole…50mg
Pharmacological Group Anti-Fungal
Type of Form Form 5
Approval Status of Product in Reference Diflucan 10 mg/ml powder for oral suspension by Pfizer
Regulatory Authorities. Limited, (MHRA approved)
Me-too Status Zefung oral suspension, 50mg/5ml by M/s Nexus Pharma
Karachi. (Reg# 081593)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Lemoxol 15/90 mg Dry Suspension
05-12-2018
Artemether…15 mg
Lumefantrine…90 mg
Pharmacological Group Anti-Malarial
Type of Form Form 5
Finished Product Specification International Pharmacopoeia specifications
Pack Size & Demanded Price 30ml, 60ml / As per SRO
Approval Status of Product in Reference WHO approved formulation
Me-too Status Artem plus dry suspension15mg+90mg/5ml by M/s Hilton
Decision:
Islamabad
Brand Name + Dosage Form + Strength Scanlux 250mg/5ml Dry Suspension
05-12-2018
Ciprofloxacin (taste Mask micro pellets 35%)…250mg
Type of Form Form 5
Pack Size & Demanded Price 30ml,60ml,100ml/ / As per SRO
Approval Status of Product in Reference Ciproxin 250 mg/5 ml granules and solvent for oral
Regulatory Authorities. suspension by M/s Bayer Healthcare, MHRA approved.
(Reg#067499
Remarks of the Evaluator.  Source of granules: Vision Pharmaceuticals,
Islamabad.
Decision:
Islamabad
Brand Name + Dosage Form + Strength Oxazolid 100mg/5ml Dry Suspension
05-12-2018
Linezolid…100mg
Pharmacological Group Anibacterial agent of Oxazolidinone class
Type of Form Form 5
Approval Status of Product in Reference Linezolid 100 mg/5 ml granules for oral suspension by M/s
Regulatory Authorities. Pfizer Limited, MHRA approved.
Me-too Status Barizold Dry Suspension100 mg/5 ml by M/s Barret
Hodgson(Reg#076343)
Decision:
Islamabad
Brand Name + Dosage Form + Strength Scanlux 125mg/5ml Dry Suspension
05-12-2018
Ciprofloxacin (taste Mask micro pellets 35%)…125mg
Type of Form Form 5
(Reg#067498)
Remarks of the Evaluator.  Source of granules: Vision Pharmaceuticals,
Islamabad.
 Registration Board in its 269th meeting decided as
follows:
Keeping in view the following statement written in
Qualitative and quantitative composition “2.5 mL
suspension after reconstitution (1/2 measuring spoon)
contains 125 mg ciprofloxacin” and domestic
conditions for difficulties in dispensing 250mg/5ml
suspension for children under 2 years of age,
Registration Board decided to approve the formulation
of ciprofloxacin 125mg/5ml granules and solvent for
oral suspension as per reference product approved by
USFDA and MHRA.
Decision:
Islamabad
Brand Name + Dosage Form + Strength Vorit 200mg/5ml Dry Suspension
05-12-2018
Composition Each 5ml reconstituted suspension contains:
Voriconazole…200mg
Pharmacological Group Triazole antifungal
Type of Form Form 5
Pack Size & Demanded Price 60ml, 70ml / As per SRO
Approval Status of Product in Reference VFEND powder for suspension 200mg/5ml by M/s PF
Regulatory Authorities. PRISM CV (USFDA Approved)
Me-too Status VORIF 200mg/5ml suspension by M/s Ferozsons
Decision:
Islamabad
Brand Name + Dosage Form + Strength Texklar 250mg/5ml DS Duspension
05-12-2018
Composition Each 5ml reconstituted suspension contains
27.5%)…125mg
Type of Form Form 5
Regulatory Authorities. Abbvie, (USFDA approved.)
(Reg#061347)
Decision:
Islamabad
Brand Name + Dosage Form + Strength ARY 200mg/5ml Dry Suspension
06-12-2018
Composition Each 5ml reconstituted suspension contains:
Acyclovir…200mg
Pharmacological Group Antiviral
Type of Form Form 5
Finished Product Specification USP (oral suspension)
Approval Status of Product in Reference Zovirax Suspension 200mg/5ml by M/s Mylan Pharma
Regulatory Authorities. Inc.(USFDA Approved)
Me-too Status Acylex Suspension 200mg/5ml by M/s Ferozsons Labs
(Reg#012684)
Remarks of the Evaluator.  Availability of applied formulation as Powder for
suspension could not be confirmed from Reference
Regulatory Authorities and available me too database
Decision:
Islamabad
Brand Name + Dosage Form + Strength Azi 200mg/5ml Dry Suspension
06-12-2018
Composition Each 5ml reconstituted suspension contains
Azithromycin (as dihydrate) as taste masked pellets
(35%)…200mg
Type of Form Form 5
Approval Status of Product in Reference Zithromax Powder for Oral Suspension 200mg/5ml by M/s
Regulatory Authorities. Pfizer Limited, (MHRA approved.)
Me-too Status Azoreg 200mg/5ml, by M/s Regal Pharmaceuticals Rawat
(Reg.# 081982)
Decision:
Evaluator PEC-VI
Liquid Ampoule SVP (General)
20 products/ 10 molecules
846. Name and address of manufacturer / M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207,
Applicant Industrial Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength AQUATEX Injection 5ml
Diary No. Date of R& I & fee DY No. 14224, 14-12-2018, Rs. 20,000, 5-12-2018
Water for injection….5ml
Type of Form Form 5
Pack size & Demanded Price 5ml x 100Amp / MRP. Rs. As per SRO
Approval status of product in Reference Sterile water for injection by M/s Pfizer Ltd (MHRA
Me-too status Aqua r ampoule by M/s Regal Pharmaceuticals (Reg.
No. 082010)
GMP status New Sections (Inspection Date: 19th Sep. 2018)
Decision:
Brand Name +Dosage Form + Strength AQUATEX Injection 10ml
Water for injection ……10ml
Pharmacological Group Diluent/solvent
Type of Form Form 5
Pack size & Demanded Price 10ml / MRP. Rs. As per SRO
Approval status of product in Reference Sterile water for injection by M/s Pfizer Ltd (MHRA
Me-too status Water for Injection of M/s Visison Pharma (Reg.#
032340)
Decision:
Brand Name +Dosage Form + Strength ROTACAINE 1% w/v Injection
Composition Each ml ampoule contains:
Lidocaine HCl …………. 10mg
Pharmacological Group Local anaesthetic
Type of Form Form 5
Pack size & Demanded Price 2ml x 50’s & 2ml x 100’s/ MRP. Rs. As per SRO
Approval status of product in Reference Lidocaine injection 1% w/v (MHRA Approved)
Me-too status Lidocaine 1% Injection of M/s Zafa Pharmaceuticals.
(Reg. # 030216)
Decision:
Brand Name +Dosage Form + Strength ROTACAINE 2% w/v Injection
Composition Each ml ampoule contains:
Lignocaine HCl …………. 20mg
Pharmacological Group Local anaesthetic
Type of Form Form 5
Pack size & Demanded Price 2ml x 50’s & 2ml x 100’s/ MRP. Rs. As per SRO
Approval status of product in Reference Lidocaine injection 2% w/v (MHRA Approved)
Me-too status Lignox 2% injection (2ml) of M/s Novamed
(Reg.#076968)
Decision:
Brand Name +Dosage Form + Strength NALPAIN Injection 10mg/ml
Nalbuphine hydrochloride …………. 10mg
Type of Form Form 5
Finished Product Specification In-House
Pack size & Demanded Price 10amp x 1ml: pack of 5’s / MRP. Rs. As per SRO
Approval status of product in Reference Approved by Health Canada
Me-too status Kinz 10mg/ml Injection by M/s Sami
Decision:
Brand Name +Dosage Form + Strength NALPAIN Injection 20mg/ml
Nalbuphine hydrochloride …………. 20mg
Type of Form Form 5
Pack size & Demanded Price 5amp x 1ml: pack of 5’s / MRP. Rs. As per SRO
Approval status of product in Reference Nubain Injection 20mg/ml by M/s Sandoz Canada
Regulatory Authorities. Incorporated, Health Canada approved
Me-too status Kinz 20mg/ml injection by M/s Sami (Reg. No.
018687)
Decision:
Brand Name +Dosage Form + Strength VOLPAN injection 100mg/2ml
Tramadol hydrochloride …………. 100mg
Pharmacological Group Opioid
Type of Form Form 5
Finished Product Specification Manufacturer specs.
Pack size & Demanded Price 5amp x 2ml: / MRP. Rs. As per SRO
Me-too status Tramal 50ml/ml Injection by M/s Searle (Reg. No.
010072)
Decision:
Brand Name +Dosage Form + Strength ROTA-D Injection
Cholecalciferol …………. 200,000IU (5mg)
Type of Form Form 5
Pack size & Demanded Price 1’s x 1ml / MRP. Rs. As per SRO
Approval status of product in Reference Vitamin D3 BON of Bouchara, France Approved
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
Decision:
Brand Name +Dosage Form + Strength AMICIN Injection 100mg/2ml
Amikacin as sulphate …………. 100mg
Pharmacological Group Antibiotic for topical use
Type of Form Form 5
Pack size & Demanded Price 2ml: pack of 1’s, 5’s & 10’s / MRP. Rs. As per SRO
Me-too status Amikin of M/s Bristol Myers (Reg. No. 010666)
Decision:
Type of Form Form 5
Approval status of product in Reference Health Canada Approved
Me-too status AMIKACIL I.M / I.V INJECTION 250MG /
1MLReg. No. 023105
Decision:
Type of Form Form 5
Pack size & Demanded Price 2ml: pack of 1’s & 10’s / MRP. Rs. As per SRO
Approval status of product in Reference Approved by Health Canada
Me-too status Kimdon Injection 500mg reg # 036915
Decision:
Brand Name +Dosage Form + Strength TRANSMIC Injection 1g /10ml
Tranexamic acid …………. 1gm
Pharmacological Group Fibrinolytic
Type of Form Form 5
Approval status of product in Reference Cyklokapron 500mg solution for injection by M/s
Regulatory Authorities. Pfizer (Could not be confirmed)
Me-too status Traxacid Injection by M/s Asian Continental (Could
not be confirmed)
Remarks of the Evaluator. International availability and me-too status could not
be confirmed.
Decision:
Brand Name +Dosage Form + Strength TRANSMIC Injection 250mg /5ml
Tranexamic acid …………. 250mg
Pharmacological Group Fibrinolytic / Haemostatic
Type of Form Form 5
Approval status of product in Reference PMDA Approved
Me-too status Tremic-250 Injection by M/s Fynk Pharma. (Reg.#
062677)
Decision:
Brand Name +Dosage Form + Strength TRANSMIC Injection 500 /5ml
Tranexamic acid …………. 500mg
Pharmacological Group Fibrinolytic
Type of Form Form 5
Approval status of product in Reference Cyklokapron 500mg solution for injection by M/s
Regulatory Authorities. Pfizer (MHRA Approved)
Me-too status Tremic-500 Injection by M/s Fynk Pharma. (Reg.#
062678)
Decision:
Brand Name +Dosage Form + Strength C-LINE Injection 1g/4ml
Citicoline (as sodium) …………. 1g
Pharmacological Group Psychostimulant Nootropics
Type of Form Form 5
Finished Product Specification Manufacturer Specs.
Approval status of product in Reference Approved by Spanish regulatory authority
Me-too status Citolin by Global Pharma
Decision:
Brand Name +Dosage Form + Strength C-LINE Injection 250mg/2ml
Citicoline (as sodium) …………. 250mg
Type of Form Form 5
Approval status of product in Reference Approved by ANSM France
Me-too status Cerebolin Injection 250mg/2ml by M/s Zam Zam
(Reg#021969)
Decision:
Brand Name +Dosage Form + Strength C-LINE Injection 500mg/4ml
Citicoline (as sodium) …………. 500mg
Type of Form Form 5
Approval status of product in Reference Citicolin Panpharma 500mg/4ml solution injectable
Regulatory Authorities. by M/s PANPHARMA; Approved by ANSM France
Me-too status SOMAZINA Injection500 by Alina pharma Reg. No.
016975
Decision:
Brand Name +Dosage Form + Strength ATRACUR Injection 25mg/2.5ml
Composition Each 2.5ml ampoule contains:
Atracurium besylate…………. 25mg
Type of Form Form 5
Pack size & Demanded Price 2.5ml: pack of 5’s / MRP. Rs. As per SRO
Approval status of product in Reference Atracurium Besilate 10mg/ml Solution for injection
Regulatory Authorities. 2.5ml (MHRA Approved)
Me-too status Atrum-3H 25mg/2.5ml Injection Reg # 039339
Decision:
Brand Name +Dosage Form + Strength ATRACUR Injection 50mg/5ml
Atracurium besylate…………. 50mg
Type of Form Form 5
Pack size & Demanded Price 5ml: pack of 5’s / MRP. Rs. As per SRO
Approval status of product in Reference Atracurium Besilate 10mg/ml Solution for injection
Regulatory Authorities. 5ml by M/s Hikma Farmaceutica (Portugal) S.A.,
(MHRA Approved)
Me-too status Atrum-3H 50mg/5ml Injection Reg # 039340
Decision:
Brand Name +Dosage Form + Strength MECONEURO Injection 500mcg/ml
Mecobalamin…………. 500mcg
Pharmacological Group Vitamin B12 analogue
Type of Form Form 5
Approval status of product in Reference PMDA Approved
Me-too status Wycomin 500 mcg Injection of Wnsfeild
Pharmaceutical
Decision:
Evaluator PEC-XIV
Sachet Section (10 molecules/ 11products)

866. Name and address of manufacturer / M/s Rotex (Pvt) Ltd. Plot No. 206 & 207, Industrial
Applicant triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength V-COL Oral Sachet
Macrogol……………..13.125 g
Sodium Chloride………0.3507 g
Sodium Bicarbonate………..0.1785 g
Potassium chloride…………0.0466 g
Pharmacological Group Osmotically acting laxative
Type of Form Form 5
Finished product Specification Manufacturer
Pack size & Demanded Price 10’s, 20’s, 30’s; As per SRO
Approval status of product in Reference Movicol 13.8g Sachet, powder for oral solution by M/s
Regulatory Authorities. Norgine limited (MHRA approved)
Me-too status Marfinal Sachet 13.8g by M/s Martin Dow (Reg#080647)
GMP status Panel inspection dated 19-09-2018 recommended the
grant of additional section (Sachet General).
Decision:
Brand Name +Dosage Form + Strength PEDICURE –R Oral Sachet
Pre-cooked Rice powder…………….6gm
Sodium chloride……………………350mg
Sodium Citrate……………………580mg
Potassium chloride………………..300mg
Pharmacological Group Electrolyte
Type of Form Form 5
Approval status of product in Reference Dioralyte Relief Blackcurrant sachet of Aventis Pharma
Regulatory Authorities. Ltd., UK (MHRA approved)
Me-too status Hilyte-R Sachet of M/s Hilton Pharma (Reg#073733)
Decision:
Brand Name +Dosage Form + Strength BRUTEX Oral Sachet
Ibuprofen (effervescent granules)……….600mg
Pharmacological Group Anti-inflammatory and anti-rheumatic
Type of Form Form 5
Finished product Specification BP specifications
Pack size & Demanded Price 14’s, 10’s, 50’s, 100’s; As per SRO
Approval status of product in Reference Brufen Granules 600mg by M/s BGP Products Ltd.
Me-too status Brufen 600mg Sachet by Abbott Laboratories (Pakistan)
Limited (Reg. # 044414)
Decision:
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
Pharmacological Group Urinary Alkaliniser
Type of Form Form 5
Me-too status Citro soda Sachet of Abbott Labs
Sodium Bicarbonate……………………1.76g
Sodium citrate………………………...0.63g
Citric acid…………………………0.72g
Tartaric acid……………………….0.98g
Me-too is different.
Decision:
Brand Name +Dosage Form + Strength MEBETEX PLUS Oral Sachet
Mebeverine HCl………………….135mg
Ispaghula Husk……………………3.5gm
Pharmacological Group Antispasmodic/laxative
Type of Form Form 5
Pack size & Demanded Price 10’s & 30’s; As per SRO
Approval status of product in Reference Fybogel Mebeverine effervescent granules by M/s Reckitt
Regulatory Authorities. Benckiser Healthcare (UK) Ltd. (MHRA approved)
Me-too status MEVULAK Sachet of M/s Sami (Reg.#076311)
Decision:
Brand Name +Dosage Form + Strength BIOFOS Oral Sachet
Fosfomycin as trometamol…………….3gm
Type of Form Form 5
Me-too status Fosib 3gm Sachet by M/s Ciba Pharmaceuticals (Reg.#
081515)
Decision:
Brand Name +Dosage Form + Strength RONITA Oral Sachet
Strontium Ranelate…………..2g
Pharmacological Group Anti-osteoporotic
Type of Form Form 5
Approval status of product in Reference PROTOS strontium ranelate 2g granules for oral
Regulatory Authorities. suspension sachet by Servier Laboratories (TGA
Australia Approved)
Me-too status Onita Sachet by PharmEvo( (Reg# 057746)
Decision:
Brand Name +Dosage Form + Strength MONTERO Oral Sachet
Montelukast as sodium…………….4mg
Pharmacological Group USP
Type of Form Form 5
Approval status of product in Reference Singulair Sachet 4mg Granules of Merck, USFDA
Me-too status Montiget Sachet of M/s GETZ Pharma
Decision:
Brand Name +Dosage Form + Strength TIME ORAL Sachet
Omeprazole…………….20mg
Sodium Bicarbonate…………..1680mg
Pharmacological Group Proton pump inhibitor / antacid
Type of Form Form 5
Me-too status Bold Insta Sachet of M/s Scotmann Pharma
Decision:
Brand Name +Dosage Form + Strength TIME ORAL Sachet
Omeprazole……………………40mg
Sodium Bicarbonate…………..1680mg
Pharmacological Group Proton pump inhibitor / antacid
Type of Form Form 5
Me-too status Bold Insta Sachet of M/s Scotmann Pharma
Decision:
Brand Name +Dosage Form + Strength OSMOLET O.R.S SACHET
Anhydrous Glucose……………..13.5g
Tri sodium citrate dihydrate………..2.9g
Sodium chloride………………….2.6g
Potassium chloride……………….1.5g
Pharmacological Group Electrolyte
Type of Form Form 5
Me-too status Peditral Low Sachet
Decision:
Evaluator PEC-XIV
Liquid Injectable Ampoule Vial General Section:10 Molecules/11 Products
877. Name and address of manufacturer / M/s Novartana Pharmaceuticals Pvt Ltd.
Applicant Plot No. 87-B, Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Novibion Injection
Pyridoxine Hydrochloride………100mg
Thiamine Hydrochloride …….…100mg
Cyanocobalamin…………….…1000mcg
Diary No. Date of R& I & fee Dy.No 2069, 17-01-2019 Rs.20,000/-, 16-01-2019
Pharmacological Group Vitamin B compounds
Type of Form Form 5
Pack size & Demanded Price Rs. 666.00/ 25 ampoules
Approval status of product in Reference Neurobion solution for Injection 3ml by M/s Merck
Regulatory Authorities. Selbstmedikation GmbH (Germany Approved)
Me-too status Neurolina Injection 3ml by M/s Alina Combine
(Reg#076143)
GMP status The central licensing Board in its 267th meeting has
considered and approved the grant following one
additional section:
Liquid Injectable ampoule/vial (General) section.
Remarks of the Evaluator. Master formulation shows fill volume 1ml while the
reference formulation is 3ml.
Decision:
Brand Name +Dosage Form + Strength Aquanov 5ml Injection
Water for Injection…………5ml
Diary No. Date of R& I & fee Dy.No 2070, 17-01-2019 Rs.20,000/-,16-01-2019
Pharmacological Group Diluent/Solvent
Type of Form Form-5
Pack size & Demanded Price Rs. 575.00/100’s
Approval status of product in Reference Sterile water for injection by M/s Pfizer Limited, MHRA
Regulatory Authorities. approved.
Me-too status Aqua R ampoule by M/s Regal Pharmaceuticals
(Reg#082010)
additional section:
Decision:
Brand Name +Dosage Form + Strength Diclonov 75mg/3ml Injection
Composition Each ampoule Contains:
Diclofenac Sodium………………75mg
Diary No. Date of R& I & fee Dy. No. 2068, 17-01-2019, Rs.20,000/-,16-01-2019
Type of Form Form 5
Pack size & Demanded Price 3264/100’s
Approval status of product in Reference Voltarol ampoules 75mg/3ml UK, (MHRA approved)
Me-too status Artecid Injection of M/s.Biolabs (Reg#075186)
additional section:
Decision:
Brand Name +Dosage Form + Strength Novalox 400mg/250ml Vial For Infusion
Composition Each 250ml Vial for Infusion Contains:
Moxifloxacin Hydrochloride eq. to
Moxifloxacin……………..400mg
Diary No. Date of R& I & fee Dy.No 2081, 17-01-2019 , Rs.20,000/-,16-01-2019
Pharmacological Group Quinolones
Type of Form Form 5
Pack size & Demanded Price 250ml; Rs. 1200.00 per pack
Approval status of product in Reference Avelox 400mg/250ml solution for infusion by Bayer,
Regulatory Authorities. MHRA approved.
Me-too status Avelox 400mg Infusion by Bayer Healthcare.
additional section:
Decision:
Brand Name +Dosage Form + Strength Novafin 10mg/ml Ampoule
Composition Each 1ml ampoule Contains:
Nalbuphine Hydrochloride.…………….10mg
Diary No. Date of R& I & fee Dy.No 2082, 17-01-2019 , Rs.20,000/- Dated 16-01-2019
Pharmacological Group Opioid analgesic
Type of Form Form 5
Pack size & Demanded Price 1ml ×5’s; Rs. 594.14 per pack
Me-too status Sonotic Injection by Brookes Pharma (Reg. # 057729)
additional section:
Decision:
Brand Name +Dosage Form + Strength Novafin 20mg/ml Ampoule
Nalbuphine Hydrochloride………..…20mg
Diary No. Date of R& I & fee Dy.No 2083, 17-01-2019, Rs.20,000/-, 16-01-2019
Pharmacological Group Opioid analgesic
Type of Form Form 5
Pack size & Demanded Price 1ml × 5’s; 945.60 per pack
Approval status of product in Reference Nubain Injection 20mg/ml by M/s Sandoz Canada
Regulatory Authorities. Incorporated,Health Canada approved
Me-too status Kinz 20mg/ml Injection by M/s Sami (Reg#018687)
additional section:
Decision:
Brand Name +Dosage Form + Strength Novamin 500mcg/ml Ampoule
Mecobalamin………………..500mcg
Pharmacological Group Coenzyme type-vitamin B12
Type of Form Form 5
Pack size & Demanded Price 1ml × 10’s; Rs. 552.00 per pack
Approval status of product in Reference Approved in PMDA
Me-too status Wycomin 500 mcg Injection of Wnsfeild Pharmaceutical
additional section:
Decision:
Brand Name +Dosage Form + Strength Novamol 1gm/100ml Infusion
Composition Each 100ml IV Infusion Contains:
Paracetamol………………….…1gm
Pharmacological Group Analesic & Antipyretic
Type of Form Form 5
Approval status of product in Reference Perfalgan 10mg/ml, solution for infusion (MHRA
Me-too status Provas Infusion 10mg/ml of M/s Sami
additional section:
Decision:
Brand Name +Dosage Form + Strength Novacip 200mg/100ml Vial for Infusion
Composition Each 1ml Vial for Infusion Contains:
Ciprofloxacin as Lactate…………….2mg
Diary No. Date of R& I & fee Dy.No 2079, 17-01-2019, Rs.20,000/-,16-01-2019
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 2 mg/ml Solution for Infusion by M/s
Regulatory Authorities. Hospira UK Ltd (MHRA)
Me-too status Reflox Infusion of M/s Regal Pharmaceutical
additional section:
Decision:
Brand Name +Dosage Form + Strength Avanic 500mg/100ml vial for Infusion
Composition Each 100ml vial of Solution for Infusion contains:
Levofloxacin Hemihydrate eq. to Levofloxacin….500mg
Diary No. Date of R& I & fee Dy.No 2073, 17-01-2019, Rs.20,000/-,16-01-2019
Pharmacological Group Fluoroquinolone Antibiotic
Type of Form Form 5
Pack size & Demanded Price Rs. 750.00 per Pack 100ml
Approval status of product in Reference Levofloxacin infusion by Teva UK
Me-too status Levaquin infusion by Barret Hodgson
additional section:
Decision:
Brand Name +Dosage Form + Strength Novotop 500mg/100ml Vial for Infusion
Composition Each 100ml vial for Infusion Contains:
Metronidazole………………..…500mg
Diary No. Date of R& I & fee Dy.No. 2084,17-01-2019, Rs.20,000/-, 16-01-2019
Type of Form Form 5
Pack size & Demanded Price 100ml; 111.60 per pack
Approval status of product in Reference Metronidazole 5mg/ml Solution for Infusion by Teva UK
Me-too status Metrodex infusion by Caraway Pharma
additional section:
Decision:
c. Remaining products of New section/New License
Evaluator PEC-III
M/s Moringa Pharmaceuticals, Lahore
The following files were received from section R-V vide letter No. F.8-6/2013-Reg-V stating that the firm was
granted two new sections against which the firm has claimed molecules / products as described in the table below:
Section No. of molecules already registered No. of new molecules applied by the firm
Tablet (General) 7 2
Capsule (General) 6 4
Tablet (General) section: Molecules-2 / Products-5

888. Name and address of M/s Moringa Pharmaceuticals. 35-A, Sunder Industrial Estate,
manufacturer / Applicant Lahore
Brand Name +Dosage Form + Alomor-M 12.5/500 mg Tablets
Strength
Alogliptin (as benzoate)…12.5mg
Metformin hydrochloride…500mg
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Pack size 1x10’s: Rs. 1000/-
Approval status of product in Kazano Tablets by Takeda Pharms
GMP status Last inspection dated 06-06-2018 Panel recommended renewal of
DML
3
Remarks of the Evaluator . 
Decision:
Brand Name +Dosage Form + Alomor-M 12.5/1000 mg Tablets
Strength
Alogliptin (as benzoate)…12.5mg
Metformin hydrochloride…1000mg
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Approval status of product in Kazano Tablets by Takeda Pharms
DML
Remarks of the Evaluator3. 
Decision:
Brand Name +Dosage Form + Levlo 1mg Tablet
Strength
Pitavastatin (as calcium)…..1mg
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Pack size 10’s: Rs. 150/-
Approval status of product in Alipza film-coated tablets by Kowa Pharmaceutical
Me-too status Pitastin Tablet by Atco
DML
Decision:
Strength
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
DML
Decision:
Strength
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
DML
Decision:
Capsule (General) Section: Molecules-4 / Products-6
Brand Name +Dosage Form + Traxid 250mg Capsule
Strength
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Approval status of product in PMDA Japan Approved
Me-too status Tranex 250mg Capsule of Mission Karachi.
DML
3
Decision:
Brand Name +Dosage Form + Traxid 500mg Capsule
Strength
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Pack size 20’s: Rs. 334.72/-
Approval status of product in Tranex Capsule by Malesci Institute Pharmacobiological SPA
Reference Regulatory Authorities. (AIFA Italy Approved)
Me-too status Statin Capsule by Wilson
DML
3
Decision:
Brand Name +Dosage Form + Ribamor 200mg Capsule
Strength
Ribavirin…200mg
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Finished Product Specification USP Specs
Approval status of product in (USFDA Approved)
Me-too status Zinger Capsule by Tabros Pharma
DML
Decision:
Brand Name +Dosage Form + Ribamor 400mg Capsule
Strength
Ribavirin…400mg
Rs. 20,000/-: 25-10-2018
Type of Form Form 5
Finished Product Specification USP Specs
Approval status of product in (USFDA Approved)
Me-too status Zinger Capsule by Tabros Pharma
DML
Decision:
Brand Name +Dosage Form + Rid-XR 150mg Capsule
Strength
Itopride SR…150mg
Rs. 20,000/-: 25-10-2018
Pharmacological Group Propulsive
Type of Form Form 5
Approval status of product in Could not be confirmed
Me-too status Itotab-OD Capsule by Opal Laboratories
DML
Remarks of the Evaluator3.  Evidence of approval of applied formulation in
reference regulatory authorities which were adopted by
Registration Board in 275th meeting.
Decision:
Brand Name +Dosage Form + Azydec 500mg Capsule
Strength
Azithromycin…500mg
Rs. 20,000/-: 25-10-2018
Pharmacological Group Macrolide antibiotic
Type of Form Form 5
Approval status of product in Available in WHO Model List of Essential Medicines 20th List
Reference Regulatory Authorities. published in March 2017 (accessed from:
https://www.who.int/medicines/publications/essentialmedicines/20t
h_EML2017.pdf?ua=1) on 4th February 2019.
Me-too status Zithrosan 500mg Capsules by Elko
DML
Decision:
Evaluator PEC-V
Capsule General Section: Applied 10 Molecules/15 Products
Capsule Section
Remaining 5 Molecules
899. Name and address of Manufacturer / M/s Dew-Max Pharmaceuticals Pvt Limited
Applicant Plot No.6, Street#SS-4, National Industrial Zone Rawat,
Islamabad
Diary No. Date of R&I & fee Dy.No 40580 dated 06-12-2018 Rs.20,000/- Dated 05-12-
2018
Brand Name+DosageForm+Strength Linco 500mg Capsule, L-Mycin, Lycin, Lencocin
Composition "Each Hard Gelatin Capsule Contains:
Lincomycin HCl eq. to Lincomycin…500mg"
Type of Form Form 5
Pack Size & Demanded Price 3x4’s, 10’s,12’s 20’s,100’s, As per SRO
Approval status of product in LINCOCINE 500 mg capsule
Reference Regulatory Authorities ANSM approved
F-Linco Capsule 500mg
M/s Fresh Pharmaceuticals, Islamabad
GMP status Grant of DML.
Decision:
Islamabad
2018
Brand Name+DosageForm+Strength Pirodex 20mg Capsule, Piro-Cam, Piro-Cap, Felcam
Piroxicam…20mg"
Pharmacological Group Antiinflammatory and antirheumatic products, non-
steroid, Oxicams
Type of Form Form 5
Pack Size & Demanded Price 1x10’s, 20’s, 100’s. As per SRO.
Approval status of product in MHRA Approved.
Camcard 20mg Capsule
M/s Ardin Karachi . .
Decision:
Islamabad
2018
Brand Name+DosageForm+Strength Fungi-EZ 150mg Capsule, Flucon, Flumax, Fungi-Nil
Fluconazole…150mg"
Pharmacological Group Antimycotics For Systemic Use
Type of Form Form 5
Pack Size & Demanded Price 1x1’s, 1x4’s, As per SRO.
"Feflozim Capsules
M/s Wisdom Pharmaceuticals Industry, 78-A Industrial
Estate, Hayatabad Peshawar
Remarks of Evaluator Present in BP, JP, IP not in USP
Decision:
Islamabad
2018
Brand Name+DosageForm+Strength Aziro 250mg Capsule, Azi-Dew, Azid, Azorax
Azithromycin Dihydrate Eq. to Azithromycin…250mg"
Type of Form Form 5
Pack Size & Demanded Price 1x10’s, 1 x6’s, As per SRO.
"Hosrin Capsules
By M/s Wisdom Pharmaceuticals Industry, 78-A
Industrial Estate, Hayatabad Peshawar
Remarks of Evaluator 3 % overage has been added.
Decision:
Islamabad
2018
Brand Name+DosageForm+Strength R-zole 10mg Capsule, Hi-Cid, Hi-Dex, Rapra, Rabra
Composition "Each Capsule Contains:
Rabeprazole Sodium Eq. to Rabeorazole as Enteric Coated
Pellets…10mg"
Pharmacological Group Proton pump inhibitors
Type of Form Form 5
Pack Size & Demanded Price 14’s, 10’s, 20’s,30’s, 50’s,100’s, As per SRO
Approval status of product in USFDA
Reference Regulatory Authorities (rabeprazole sodium)
Me-too status Me too in this strength could not be firmed.
Remarks of Evaluator  Source of pellets.
along with registration number, brand name and
name of firm.
Decision:
Islamabad
2018
Brand Name+ Dosage Form+ R-zole 20mg Capsule, Hi-Cid, Hi-Dex, Rapra, Rabra
Strength
Composition "Each Capsule Contains:
Rabeprazole Sodium Eq. to Rabeorazole as Enteric Coated
Pellets…20mg"
Type of Form Form 5
Pack Size & Demanded Price 14’s, 10’s, 20’s,30’s, 50’s,100’s, As per SRO
Approval status of product in Not confirmed in this strength.
Rebeadvan capsule 20mg
M/s Advanced Pharmaceuticals, RCCI, Rawat
Remarks of Evaluator  Source of pellets.
in its 275th meeting.
Decision:
Evaluator PEC-VIII
CLB in its 238th Meeting held on 19th November, 2014 has considered & approved the grant of Capsule
Section (general) & Renewal of Injectable Ampoule (Psychotropic) Section of M/s. Venus Pharma, 23
km Multan road, Lahore.
R-V vides its letter No. F.8-6/2013-Reg-V dated 14th of November, 2018 informed about three molecules &
products registered in the Psychotropic Injection section:
Sr. Section Name of drug

No.
1. Renewal of Injectable Ampoule Nalbuphine hydrochloride
(Psychotropic) Section 20mg/ml Injection.
Tramadol hydrochloride
50mg/ml Injection.
Ephedrine (as sulphate) 50mg/ml
Injection
Now the applicant has applied for the following:
Injectable Ampoule (Psychotropic) Section; Molecule:07, Products; 07

905. Name and address of M/s Venus Pharma 23 km Multan Road, Lahore.
Brand Name +Dosage Form + Predol Injection 5mg
Strength
Diary No. Date of R& I & fee Dy No.17645, 11-05-2018, Rs.20,000/-
Haloperidol….5mg
Pharmacological Group Antipsychotics
Type of Form Form-5
Finished Product Specification USP Specification
Pack size & Demanded Price 25’s (1ml); Rs.250/-

Me-too status Halotec Plain Injection of Pharmatec Karachi
GMP status GMP Certificate issued on 27-08-2018
Previous Decision Registration Board in its 286th meeting deferred the case for
detailed deliberation in next meeting.
Evaluation by PEC Applied formulation does not fall in the category of controlled
drugs.
Decision:
Brand Name +Dosage Form + Fluzine Injection 25mg IM
Strength
Fluphenazinedecanoate….25mg
Type of Form Form-5
Finished Product Specification USP Specification
Pack size & Demanded Price 1’s (1ml); Rs.95/-,10’s (1ml); Rs.650/-
Me-too status Halotec Plain Injection of Pharmatec Karachi
drugs.
Decision:
Brand Name +Dosage Form + Viogesic Injection 0.3mg
Strength
Buprenorphine(as hydrochloride) ….0.3mg
Type of Form Form-5
Pack size & Demanded Price 5’s (1ml); Rs.95/-,10’s (1ml); Rs.650/-
Me-too status Segesic Injection 0.3mg/ml of Saydon Pharmaceuticals
Industries
Remarks of the Evaluator. Applied formulation is not present in Available BP & USP.
Evaluation by PEC
Decision:
Brand Name +Dosage Form + Diazocin Injection
Strength
Diazepam….5mg
Type of Form Form-5
Pack size & Demanded Price 5’s (2ml); As per SRO

Me-too status Dipam 5mg Injection of Medicraft Pharmaceuticals (Pvt) Ltd
Evaluation by PEC
Decision:
Brand Name +Dosage Form + Midazocin Injection
Strength
Midazolam (as hydrochloride)….1mg/ml
Type of Form Form-5
Pack size & Demanded Price 5’s & 10’s (5ml); As per SRO
Approval status of product in Approved in US-FDA but discontinued however it is mentioned
Reference Regulatory Authorities. **Federal Register determination that product was not
discontinued or withdrawn for safety or efficacy reasons**
Me-too status Midaz 5mg/5ml Injection of Sami
Evaluation by PEC
Decision:
Brand Name +Dosage Form + Chlorozine Injection
Strength
Chlorpromazine hydrochloride….25mg
Type of Form Form-5
Pack size & Demanded Price 10’s (2ml); Rs.250/-

Approval status of product in Approved in MHRA (Emc)
Me-too status Chlorpromazine 2ml Injection Of Indus Pharma

drugs.
Decision:
Brand Name +Dosage Form + Morfin Injection
Strength
Morphine sulphate….10mg
Type of Form Form-5
Pack size & Demanded Price 100’s (1ml); As per SRO

Me-too status Morfscot Injections 10mg of Scotsmann Pharmaceuticals,
Remarks of the Evaluator. Reference product is approved as morphine sulphate

pentahydrate 10mg/ml Injection which is different from applied
formulation i.e. morphine sulphate 10mg/ml injection. Submit
Form 5, master formulation & manufacturing method in
accordance with label claim.
Evaluation by PEC
Decision:
Evaluator PEC-XII
Case. No. M/s Roryan Pharmaceuticals, Peshawar. (New Section)
The Central Licensing Board in its 266th meeting held on 24th Oct, 2018 has considered and approved the grant of
15 additional section of firm M/s Roryan Pharmaceuticals Pvt Ltd. 85/B-Hayatabad Industrial Estate, Peshawar,
KPK, Pakistan (DML:000566) as under:-
1 Cream/ ointment (General) 11 10

Cream/ ointment (General)
11 Products/ Molecule
912. Name and Address of Manufacturer / M/s Roryan Pharmaceuticals Pvt Ltd.
Applicant 85/B-Hayatabad Industrial Estate, Peshawar, kpk, Pakistan
Brand Name + Dosage Form + Strength Scabicef 5% w/w Topical Cream
04-12-2018
Composition Each Gram Topical Cream Contains:
Permethrin…50mg (5%w/)
Pharmacological Group Ectoparasiticides, incl. scabicides (Pyrethrines, incl.
synthetic compounds)
Type of Form Form 5
Pack Size & Demanded Price 30g/As per SRO
Approval Status of Product in Reference Permethrin 5% w/w Cream by M/s Sandoz Limited
Me-too Status Lotrix cream 5% by M/s WELLCOME (Reg#010516)
GMP Status 19-09-2018 amd 03-10-2018
Grant of Additional sections and cGMP certificate
Panel recommends Grant of Additional sections and
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Burnomit 1% w/w Topical Cream
04-12-2018
Silver Sulfadiazine…10mg (1%w/w)
Pharmacological Group Chemotherapeutics for topical use (Sulfonamides)
Type of Form Form 5
Pack Size & Demanded Price 15g/As per SRO
Approval Status of Product in Reference Flamazine 1%w/w Cream by M/s B&S Healthcare (MHRA
Me-too Status SILZIN cream 1% by M/s COMBAT EURASIAN
PHARMA (Reg#007484)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Robizol 1% w/w Topical Cream
04-12-2018
Bifonazole…10mg (1%w/w)
derivatives)
Type of Form Form 5
Approval Status of Product in Reference Canesten Bifonazole Once Daily Athlete’s Foot 1% w/w
Regulatory Authorities. Cream
Me-too Status MYCOSPOR cream 1% by M/s BAYER (Reg#007484)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Fungicef 1% w/w Topical Cream
04-12-2018
Econazole nitrate…10mg (1%w/w)
derivatives)
Type of Form Form 5
Approval Status of Product in Reference Pevaryl 1% Topical cream by M/s Janssen-Cilag Limited
Me-too Status ECONAZOLE NITRATE 1% cream by M/s
JOHNSON&JOHNSON (Reg#004314)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Ketozol 2% w/w Topical Cream
04-12-2018
derivatives)
Type of Form Form 5
Approval Status of Product in Reference Daktarin Gold 2% Cream by M/s McNeil Products Limited
Me-too Status Myxole Cream 2% by M/s Caraway (Reg#050020)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Romifin 1% w/w Topical Cream
04-12-2018
Terbinafine hydrochloride …10mg (1% w/w)
Pharmacological Group Other antifungals for topical use
Type of Form Form 5
Approval Status of Product in Reference LAMISIL 1% w/w Cream by M/s GlaxoSmithKline
Regulatory Authorities. Consumer Healthcare (UK) Trading Limited (MHRA
Approved)
Me-too Status Lamisil Cream 1% by M/s Sandoz (Reg.#)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Rosidic 2% w/w Topical Cream
04-12-2018
Fusidic Acid…20mg (2% w/w)
Type of Form Form 5
Approval Status of Product in Reference Fucidin 20 mg/g Cream by M/s LEO Laboratories Limited
Me-too Status FUCIDIN CREAM by M/s Leo (Reg.#015539)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Rotrim 1% w/w Topical Cream
04-12-2018
Pharmacological Group Azole Antifungal
Type of Form Form 5
Approval Status of Product in Reference Clotrimazole 1% w/w Cream by M/s Teva UK Limited
Regulatory Authorities. (MHRA approved)
Me-too Status Dermofit 1% Cream by M/s Baxter (Reg#073438)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Pirocin 2% w/w Topical Ointment
04-12-2018
Composition Each Gram Topical Ointment Contains:
Mupirocin Calcium…20mg (2% w/w)
Type of Form Form 5
Approval Status of Product in Reference Bactroban 2% Ointment by M/s GlaxoSmithKline (MHRA
Me-too Status Bactroban 2% Ointment by M/s GlaxoSmithKline
(Reg#010399)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Remarks of the Evaluator.  Firm has applied as Mupirocin Calcium…20mg where
as approved formulation in MHRA, AIFA (Italy) is
Mupirocin …20mg.
Decision:
Brand Name + Dosage Form + Strength Clindacef-V 2% w/w Vaginal Cream
04-12-2018
Composition Each Gram Vaginal Cream Contains:
Clindamycin (as phosphate) …20mg (2%w/w)
Pharmacological Group Antibiotics
Type of Form Form 5
Approval Status of Product in Reference Clindamycin 2% w/w Vaginal Cream by M/s Pfizer Inc.,
Regulatory Authorities. USA (MHRA Approved)
Me-too Status Dalacin Vaginal Cream 2% by M/s UPJOHN PAKISTAN
(Reg#018574)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Brand Name + Dosage Form + Strength Rotrim 10% w/w Vaginal Cream
04-12-2018
Composition Each Gram Vaginal Cream Contains:
derivatives)
Type of Form Form 5
Approval Status of Product in Reference Canestan 10% Vaginal cream of M/s Bayer plc (MHRA
Me-too Status Vaginex-1 Cream of M/s Global Pharmaceuticals
(Reg#022368)
GMP Status 19-09-2018 amd 03-10-2018
cGMP certificate
Decision:
Case. No. M/s Maxitech (Pvt.) Ltd, Karachi. (New Section)
CLB in its 266th meeting held on 24th October, 2018 has considered and granted additional sections to M/s
Maxitech Pharma (Pvt.) Ltd. Accordingly, firm has applied for following products for consideration by Drug
Registration Board.
1 Oral Dry Powder Suspension 19 08

(Cephalosporin) Section
2 Dry Powder Vial Injection (Cephalosporin) 26 09
Section
Oral Dry Powder Suspension (Cephalosporin) Section
923. Name and Address of Manufacturer / M/s Maxitech Pharma (Pvt) Ltd,
Applicant Factory, E-178, SITE, Karachi
Brand Name + Dosage Form + Strength CEFUR DRY POWDER SUSPENSION 125mg/5ml
Diary No. Date of R & I & fee Dy No. 41899: 07-12-2018
PKR 20,000/-: 7-12-2018
Composition Each 5ml suspension after reconstitution contains:
Cefuroxime (as axetil) …125 mg
Pharmacological Group 2nd Generation Cephalosporin Antibiotics
Type of Form Form 5
Pack Size & Demanded Price 60ml :As per SRO
Approval Status of Product in Reference Zinnat Suspension 125mg/5ml by M/s Glaxo Wellcome
Me-too Status Razicef 125mg/5ml Suspension of M/s Raazee
Therapeutics (Reg.# 068059)
GMP Status Last inspection report dated 11-6-2018 confirms
satisfactory compliance to GMP
Brand Name + Dosage Form + Strength CEFUR DRY POWDER SUSPENSION 250mg/5ml
PKR 20,000/-: 7-12-2018
Cefuroxime (as axetil) …250 mg
Type of Form Form 5
Approval Status of Product in Reference Zinnat Suspension 250mg/5ml by M/s Glaxo Wellcome
Me-too Status Razicef 250mg/5ml Suspension of M/s Raazee
Therapeutics (Reg.# 068066)
Decision:
Brand Name + Dosage Form + Strength DINCEF DRY POWDER SUSPENSION 125mg/5ml
PKR 20,000/-: 5-12-2018
Cefdinir …125 mg
Pharmacological Group 3rd Generation Cephalosporin Antibiotics
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)
Brand Name + Dosage Form + Strength DINCEF DRY POWDER SUSPENSION 250mg/5ml
PKR 20,000/-: 7-12-2018
Cefdinir …250 mg
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
Pharmaceuticals (Reg. No. 075526)
Decision:
Brand Name + Dosage Form + Strength MAXLOR DRY POWDER SUSPENSION 125mg/5ml
PKR 20,000/-: 7-12-2018
Cefaclor (as monohydrate) …125 mg
Type of Form Form 5
Approval Status of Product in Reference Cefaclor 125mg/5ml Suspension by M/s Strides Pharma
Regulatory Authorities. UK Ltd (MHRA approved)
Me-too Status Sac-Lor 125mg/5ml Dry Suspension by M/s Semos
Pharma (Reg#081617)
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Cefaclor for Oral Suspension 187mg/5ml USP
Regulatory Authorities. by Yung Shin Pharmaceutical Ind. Co., Ltd. Taiwan
(USFDA Approved)
Me-too Status Ceclor 187mg/ 5ml dry suspension by AGP (Reg#053182)
Decision:
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Cefaclor 250mg/5ml Suspension by M/s Strides Pharma
Regulatory Authorities. UK Ltd (MHRA approved)
Me-too Status Sac-Lor 250mg/5ml Dry Suspension by M/s Semos
Pharma (Reg#081618)
Drops
PKR 20,000/-: 7-12-2018
Cefaclor (as monohydrate) …50mg
Type of Form Form 5
Approval Status of Product in Reference Cefaclor for Oral Suspension 250mg/5ml by Yung Shin
Regulatory Authorities. Pharmaceutical Ind. Co., Ltd. Taiwan
(FDA Approved)
Me-too Status Ceclor Drops 50mg/1ml by Eli Lilly (Reg#013583)
Remarks of the Evaluator. The formulation applied by the firm translates to Cefaclor
(as monohydrate) 250mg/5ml which the firm has also
applied by name of MAXLOR DRY POWDER
SUSPENSION 250mg/5ml.
Decision:
Brand Name + Dosage Form + Strength MEFIX DRY POWDER SUSPENSION 100mg/5ml
PKR 20,000/-: 7-12-2018
Cefixime (as trihydrate) …100 mg
Type of Form Form 5
Approval Status of Product in Reference SUPRAX® (cefixime) for oral suspension 100mg/5ml by
Regulatory Authorities. M/ Lupin Pharmaceuticals, Inc. (USFDA Approved)
Me-too Status Bestar dry Suspension 100mg/5ml by M/s Elko
(Reg#073247)
Brand Name + Dosage Form + Strength MEFIX DS DRY POWDER SUSPENSION 200mg/5ml
PKR 20,000/-: 7-12-2018
Cefixime (as trihydrate) …200 mg
Type of Form Form 5
Approval Status of Product in Reference SUPRAX® (cefixime) for oral suspension 200mg/5ml by
Regulatory Authorities. M/ Lupin Pharmaceuticals, Inc. (USFDA Approved)
Me-too Status Bestar DS dry Suspension 200mg/5ml by M/s Elko
(Reg#037036)

Decision:
Brand Name + Dosage Form + Strength OXIMAX DRY POWDER SUSPENSION 40mg/5ml
PKR 20,000/-: 7-12-2018
Cefpodoxime (as proxetil) …40 mg
Type of Form Form 5
Approval Status of Product in Reference Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz GMBH, (MHRA approved)
Me-too Status Apodox Dry Suspension by M/s Alliance (Reg#054697)
Brand Name + Dosage Form + Strength OXIMAX DRY POWDER SUSPENSION 100mg/5ml
PKR 20,000/-: 7-12-2018
Cefpodoxime (as proxetil) …100 mg
Type of Form Form 5
Approval Status of Product in Reference Cefpodoxime Proxetil 100 mg/5ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz GMBH, (USFDA approved)
Me-too Status Qink Dry Suspension 100mg/5ml by Wilshire Laboratories
(Pvt) Ltd. (Reg#053636)
Decision:
Brand Name + Dosage Form + Strength OZIX DRY POWDER SUSPENSION 125mg/5ml
PKR 20,000/-: 7-12-2018
Cefadroxil (as monohydrate) …125 mg
Pharmacological Group 1st Generation Cephalosporin Antibiotics
Type of Form Form 5
Approval Status of Product in Reference ORACEFAL 125 mg / 5 ml powder for oral suspension by
Regulatory Authorities. M/s Bristol - Myers Squibb (ANSM Approved)
Me-too Status Evacef Suspension 125mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011213)
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Me-too Status Evacef Suspension 250mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011214)
Decision:
Drops
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Me-too Status DROMAX DROPS 100mg/1ml by Bosch (Reg#039441)
Brand Name + Dosage Form + Strength PRIMICEF DRY POWDER SUSPENSION 125mg/5ml
PKR 20,000/-: 7-12-2018
Cephalexin (as monohydrate) …125mg
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
(Reg#078699)
Decision:
Brand Name + Dosage Form + Strength PRIMICEF DRY POWDER SUSPENSION 250mg/5ml
PKR 20,000/-: 7-12-2018
Cephalexin (as monohydrate) …250mg
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
(Reg#078700)
Brand Name + Dosage Form + Strength PRIMIDIN DRY POWDER SUSPENSION 125mg/5ml
PKR 20,000/-: 7-12-2018
Cephradine …125 mg
Type of Form Form 5
Approval Status of Product in Reference Velosef Oral Suspension 125mg/5ml
Regulatory Authorities. by APOTHECON (USFDA Approved) (Discontinued)
Me-too Status Licef Dry Powder suspension 125mg/5ml by M/s Wisdom
Brand Name + Dosage Form + Strength PRIMIDIN DRY POWDER SUSPENSION 250mg/5ml
PKR 20,000/-: 7-12-2018
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
Decision:
Dry Powder Vial Injectable (Cephalosporin) Section
Brand Name + Dosage Form + Strength CEFUR 1.5gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Composition Each Vial contains:
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
Regulatory Authorities. by M/s Stragen UK Limited (MHRA Approved)
Me-too Status Zecef Injection 1.5gm by M/s Bosch Pharmaceuticals (Pvt)
Ltd, (Reg#026898)
Brand Name + Dosage Form + Strength CEFUR 250mg IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefuroxime (as sodium) ...250mg
Type of Form Form 5
Approval Status of Product in Reference Cefuroxime 250 mg powder for solution for injection by
Regulatory Authorities. M/s Stragen UK Limited (MHRA Approved)
Me-too Status ZINACEF 250MG INJ by M/s GSK Pakistan
(Reg#006221)
Decision:
Brand Name + Dosage Form + Strength CEFUR 750mg IM/IV Injection

PKR 20,000/-: 7-12-2018
Cefuroxime (as sodium) ...250mg
Type of Form Form 5
Approval Status of Product in Reference Cefuroxime 750 mg powder for solution for injection by
Regulatory Authorities. M/s MIP Pharma GmbH (MHRA Approved)
Me-too Status ZINACEF 750MG INJ by M/s GSK Pakistan
(Reg#006222)
Brand Name + Dosage Form + Strength FORTEX 1gm IM/IV Injection
PKR 20,000/-: 5-12-2018
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
Medicaid, Karachi (Reg#080279)
Decision:
Brand Name + Dosage Form + Strength FORTEX 250 IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefotaxime (as sodium) …250mg
Type of Form Form 5
Approval Status of Product in Reference Claforan Injection 250mg by M/s Aventis Pharma Limited
Me-too Status Getex Dry Powder Injection 250mg by M/s Amarant from
Medicaid, Karachi (Reg#080277).
Brand Name + Dosage Form + Strength FORTEX 500mg IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefotaxime (as sodium) …500mg
Type of Form Form 5
Approval Status of Product in Reference Claforan Injection 500mg by M/s Aventis Pharma Limited
Me-too Status Getex Dry powder Injection 500mg by M/s Amarant from
Medicaid, Karachi (Reg#080278)
Decision:
Brand Name + Dosage Form + Strength MAROME 1gm IV Injection
PKR 20,000/-: 7-12-2018
Cefpirome (as sulphate) …1gm
Pharmacological Group 4th Generation Cephalosporin Antibiotics
Type of Form Form 5
Approval Status of Product in Reference CEFROM 1 g / 10 ml, powder and solvent for solution for
Regulatory Authorities. injection (IV) by M/s SANOFI AVENTIS FRANCE
(ANSM Approved)
Me-too Status IVCEF 1g Injection by Bosch (Reg#027732)
Brand Name + Dosage Form + Strength MAXZO 1gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefoperazone (as sodium) …500mg
Sulbactam (as sodium) …500mg
Pharmacological Group 3rd Generation Cephalosporin Antibiotics/Beta-lactamase
inhibitors
Type of Form Form 5
Approval Status of Product in Reference Sulperazon Injection by Pfizer Inc. PMDA Approved
Me-too Status Cebac Injection 1gm by M/s Bosch (Reg#037630)
Decision:
Brand Name + Dosage Form + Strength MAXZO 2gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefoperazone (as sodium) …1000mg
Sulbactam (as sodium) …1000mg
Pharmacological Group 3rd Generation Cephalosporin Antibiotics/Beta-lactamase
inhibitors
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)
Brand Name + Dosage Form + Strength MAXZON 1gm IM Injection
PKR 20,000/-: 7-12-2018
Ceftriaxone (as sodium) …1gm
Type of Form Form 5
Approval Status of Product in Reference Rocephin IM 1 g Powder and Solvent for Solution for
Regulatory Authorities. Injection by M/s Roche Products Ltd (MHRA Approved)
Me-too Status Rocphin 1000mg IM Injection by M/s ROCHE
(Reg#008437)
Decision:
Brand Name + Dosage Form + Strength MAXZON 1gm IV Injection
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Rocephin IV 1 g Powder and Solvent for Solution for
Me-too Status Rocphin 1000mg IV Injection by M/s ROCHE
(Reg#008436)
Brand Name + Dosage Form + Strength MAXZON 2gm IM Injection
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Ceftriaxone 2 g Powder for Solution for Injection/Infusion
Regulatory Authorities. (IM) by Sandoz Limited (MHRA Approved)
Me-too Status Cesod 2000mg IM Injection by M/s Amson (Reg#052404)
Decision:
Brand Name + Dosage Form + Strength MAXZON 2gm IV Injection
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Ceftriaxone 2 g Powder for Solution for Injection/Infusion
Regulatory Authorities. (IV) by Sandoz Limited (MHRA Approved)
Me-too Status Cesod 2000mg IV Injection by M/s Amson (Reg#052403)
Brand Name + Dosage Form + Strength MAXZON 250mg IM Injection
PKR 20,000/-: 7-12-2018
Ceftriaxone (as sodium) …250mg
Type of Form Form 5
Approval Status of Product in Reference Rocephin IM 250 mg Powder and Solvent for Solution for
(Reg#008432)
Decision:
Brand Name + Dosage Form + Strength MAXZON 250mg IV Injection
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Rocephin IV 250 mg Powder and Solvent for Solution for
(Reg#008433)
Brand Name + Dosage Form + Strength MAXZON 500mg IM Injection
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Rocephin IM 500 mg Powder and Solvent for Solution for
(Reg#008434)
Decision:
Brand Name + Dosage Form + Strength MAXZON 500mg IV Injection
PKR 20,000/-: 7-12-2018
Type of Form Form 5
Approval Status of Product in Reference Rocephin IV 500 mg Powder and Solvent for Solution for
(Reg#008435)
Brand Name + Dosage Form + Strength MAZOLIN 1gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefazolin (as sodium) …1gm
Type of Form Form 5
Approval Status of Product in Reference Cefazolin 1g Powder for solution for injection/infusion by
Regulatory Authorities. M/s Noridem Enterprises Ltd (MHRA Approved)
Me-too Status Safelin Injection 1 gm by M/s Fassgen Pharmaceuticals
(Reg#074513)
Decision:
Brand Name + Dosage Form + Strength MEZOX 1gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Ceftizoxime (as sodium) …1gm
Type of Form Form 5
Approval Status of Product in Reference Cefizox 1gm Injection by M/s Astellas Pharma US, Inc
Regulatory Authorities. (USFDA Approved) (Discontinued)
Me-too Status Tezox 1gm Injection by Bosch (Reg#034853)
Remarks of the Evaluator.  Applied formulation is discontinued in FDA.
Brand Name + Dosage Form + Strength MEZOX 500mg IM/IV Injection
PKR 20,000/-: 7-12-2018
Ceftizoxime (as sodium) …500mg
Type of Form Form 5
Approval Status of Product in Reference Cefizox 1gm Injection by M/s Astellas Pharma US, Inc
Regulatory Authorities. (USFDA Approved) (Discontinued)
Me-too Status Tezox 500mg Injection by Bosch (Reg#034852)
Remarks of the Evaluator.  Applied formulation is discontinued in FDA.
Brand Name + Dosage Form + Strength XADIME 1gm IM/IV Injection
PKR 20,000/-: 7-12-2018
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:
Brand Name + Dosage Form + Strength XADIME 250MG IM/IV Injection
PKR 20,000/-: 7-12-2018
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
Me-too Status Panacef Injection 250mg by M/s CCL (Reg# 023858)
Brand Name + Dosage Form + Strength XADIME 500MG IM/IV Injection
PKR 20,000/-: 7-12-2018
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:
Brand Name + Dosage Form + Strength XPIME 1gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefepime (as hydrochloride)…1gm
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 Pharmaceuicals (Reg#
060250)
Brand Name + Dosage Form + Strength XPIME 2gm IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefepime (as hydrochloride)…2gm
With L-Arginine
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:
Brand Name + Dosage Form + Strength XPIME 500mg IM/IV Injection
PKR 20,000/-: 7-12-2018
Cefepime (as hydrochloride)…500mg
With L-Arginine
Type of Form Form 5
Approval Status of Product in Reference Cefipime hydrochloride 500mg Injection by M/s Hospira,
Regulatory Authorities. Inc. (USFDA approved)
Me-too Status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060251)
Evaluator PEC-XIII
968. Name and address of manufacturer / M/s Horizon Healthcare (Pvt.) Ltd, Plot # 35-A Small
Applicant Industrial Estate, Taxilla.
Brand Name +Dosage Form + Strength Vinocare Injection 500mg
Vancomycin as Hydrochloride (lyophilized ready-to-fill
powder).................................................................500mg
Pack size & Demanded Price 1x 1’s vial & as per SRO
Me-too status Hisun injection 500mg of M/s Bio- Care Pharma
(Reg.# 052214)
the report concludes that company has shown good
response and rectified the problems and has shown good
compliance as per schedule B-II.
Remarks of the Evaluator  General Dry powder Vial section is available in
the firm as mentioned in the GMP inspection
report.
Decision:
Brand Name +Dosage Form + Strength Vinocare Injection 1g
Vancomycin as Hydrochloride (lyophilized ready-to-fill
powder)........................................................................1g
Pack size & Demanded Price 1x 1’s vial & as per SRO
Me-too status Vancocin injection 1 g of M/s Biolabs Laboratories
(Reg.# 075191)
Remarks of the Evaluator  General Dry powder Vial section is available in
the firm as mentioned in the GMP inspection
report.
Decision:
Brand Name +Dosage Form + Strength Erynate Injection 30mg
Artesunate ……...30mg
Pack size & Demanded Price Pack of one vial containing Artesunate 30mg + 1
ampoule of w. f. i. 5ml+ 1 ampoule 2ml Lignocaine (1x
1’s) & as per SRO
Approval status of product in WHO recommended formulation
Me-too status Gen-M Injection by M/s Genix Pharma Karachi
(Reg. # 076072)
Pharmacopoeia.
 General Dry powder Vial section is available in
the firm.
Decision:
Artesunate ….…..60mg
ampoule of w. f. i. 5ml+ 1 ampoule 2ml Lignocaine (1x
1’s) & as per SRO
Approval status of product in WHO prequalified formulation
Me-too status Misonate 60mg Injection of M/s Tabros Pharma
(Reg. # 057719)
Pharmacopoeia.
the firm.
Decision:
Artesunate ……..120mg
ampoule of w. f. i. 5ml + 1 ampoule 2ml Lignocaine (1x
1’s) & as per SRO
Approval status of product in WHO prequalified formulation
Me-too status Gen-M Injection by M/s Genix Pharma Karachi
(Reg. # 076073)
Pharmacopoeia.
the firm.
Decision:
d. Deferred cases
Evaluator PEC-VIII
973. Name and address of Manufacturer / M/s Winlet Pharmaceuticals 30km Sargodha Road,
Applicant Lahore.
Brand Name +Dosage Form +Strength Ciplox750mg tablets
Ciprofloxacin hydrochloride …750mg
Type of Form Form-5
GMP status New License (Issuance Date: 26th Feb 2018)
Previous decision Registration Board in its 282nd meeting deferred the case
for the following reasons:
 Clarification of composition as reference product is
approved as Ciprofloxacin (as hydrochloride
monohydrate) 750 mg film coated tablet which is
different from applied formulation i.e ciprofloxacin
hydrochloride 750 film coated tablet.
 Submission of fee for revision of formulation.
Evaluation by PEC The firm has now submitted the following:

 Revised Form 5, Master Formulation,
Manufacturing Method in-Line with reference
product so the new composition is as follows:
 Applicant further submitted that as it is only
correction in equivalency of salt of API which
requires no fee.
Decision:
Applicant Lahore.
Brand Name +Dosage Form +Strength Ciplox tablet 250mg
Ciprofloxacin hydrochloride …....250mg
Type of Form Form-5
Finished Product Specification USP specifications
Regulatory Authorities Ciproxin 250mgFilm-CoatedTablets by Bayer
hydrochloride 250 film coated

requires no fee.
Decision:
Applicant Lahore.
Brand Name +Dosage Form +Strength Ciplox tablet 500mg

Ciprofloxacin hydrochloride … 500mg
Type of Form Form-5
Finished Product Specification USP specifications
Pack Size & Demanded Price 10’s, 14’s, 28’s; As per SRO
hydrochloride 500 film coated

requires no fee.
Decision:
The firm has requested for withdrawal of their already applied one molecule i.e. Amlodipine as besylate/
Telmisartan Combination tablet having following strengths 10/40, 10/80 ,5/40,5/80, which was considered
in 281st RB meeting against New License (Tablet General Section)… the applicant further requested to
replace the above stated molecule with Nebivolol 5mg, & 10mg.
APPLICATIONS TO BE CONSIDERED IN REPLACEMENT
976. Name and address of Manufacturer / M/s Medpharm Research Lab 28 km, Ferozepur
Applicant Road, Lahore
Brand Name + Dosage Form+ Strength Medivolol 5mg Tablet
Nebivolol…5mg
Type of Form Form 5
compliance.
Decision:
977. Name and address of M/s Medpharm Research Lab 28 km, Ferozepur
Manufacturer/Applicant Road, Lahore
Brand Name + Dosage Form + Strength Medivolol 2.5mg Tablet
Nebivolol…2.5mg
Pharmacological group Beta blocker
Type of Form Form 5
Approval status of product in reference Approved in US-FDA
regulatory authorities
Me-too status Nebil 2.5mg Tablet of Getz Karachi
GMP Status GMP Inspection conducted on 12-12-2017 concluded
compliance.
Decision:
PREVIOUSLY DEFERRED APPLICATIONS
1. Name and address of manufacturer / M/s MedPharm Research Lab.
Applicant 28-Km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Telmo Tablet 10mg/40mg
Diary No. Date of R& I & fee Diary No: 12612, 05-04-2018, Rs: 20,000/-
blockers
Type of Form Form-5
Regulatory Authorities. Mylan Pharmaceuticals Inc. (USFDAA approved)
Me-too status Amtas 10mg +40mg Tablet by M/s Getz Pharma (Pvt)
Ltd (Reg#066945)
Grant of new DML,
Remarks of the Evaluator. ● In reference regulatory authorities like in EMA
tablet, while the applied drug is single layered
tablet.
Decision:
Deferred for the clarification of manufacturing outline as in reference regulatory authorities the
approved drug is multilayered tablet, while the applied drug is mono layered tablet.
blockers
Type of Form Form-5
Ltd (Reg#066943)
Grant of new DML,
tablet.
Decision:
blockers
Type of Form Form-5
Ltd (Reg#066944)
Grant of new DML,
tablet.
Decision:
blockers
Type of Form Form-5
(Reg#073767)
Grant of new DML,
tablet.
Decision:
Evaluator PEC-IX
978. Name and address of Zeta Pharmaceuticals Plot # 494-A, Sunder Industrial Estate,
manufacturer / Applicant Multan Road Lahore
Brand Name +Dosage Form + Sodazet Sachet
Strength
Citric Acid (USP)…….0.72g
Sodium Citrate (USP)…….0.63g
Sodium Bicarbonate (USP) …..1.76g
Tartaric Acid (NF)……… 0.89g
PKR 20,000/-: 17.08.2018
Pharmacological Group Antacid
Type of Form Form 5
Finished Product Specification The firm has claimed Innovator’s specs.
Pack size & Demanded Price 20’s, Rs. 230/-
Approval status of product in Ural Effervescent Granules sachets approved by TGA
Authorities.
Me-too status Citro Soda granules by Abbott Laboratories. Reg. No. 8749
GMP status The firm has granted Additional Section (Sachet, General) on the basis
of inspection dated 28.05.2018
Remarks of the Evaluator.  The firm revised the composition in Form 5 and revised
the formulation from Powder to granules with submission of Rs.
5000/- fee.
submission of differential fee of Rs. 15000/- for revision of strength
of applied formulation
Evaluation by PEC The firm submitted differential fee.
Dy No. 3610: 25.01.2019
PKR 15,000/-: 25.01.2019
Decision:
979. Name and address of Zeta Pharmaceuticals Plot # 494-A, Sunder Industrial Estate,
manufacturer / Applicant Multan Road Lahore
Brand Name +Dosage Form + Osteozet Sachet
Strength
Strontium Renelate…….2g
PKR 20,000/-: 17.08.2018
Pharmacological Group Drugs for treatment of bone diseases
Type of Form Form 5
Finished Product Specification The firm has claimed Innovator’s specs.
Pack size & Demanded Price 7’s, Rs.770/-
Approval status of product in Strontium ranelate Aristo 2 g granules for oral suspension by Aristo
Reference Regulatory Pharma GmbH, approved by MHRA
Authorities.
Me-too status Strate 2g Sachet by Platinum Pharmaceuticals, Karachi Reg. No.
70841
GMP status The firm has granted Additional Section (Sachet, General) on the basis
of inspection dated 28.05.2018
Remarks of the Evaluator.  The firm revised Strontium Renelate 2mg to Strontium
Renelate 2g and from Powder to granule with submission of Rs.
5000/- fee.
submission of differential fee of Rs. 15000/- for revision of strength
of applied formulation
Evaluation by PEC The firm submitted differential fee.
Dy No. 3609: 25.01.2019
PKR 15,000/-: 25.01.2019
Decision:
980. Name and address of Trillium Pharmaceuticals (Pvt) Ltd. Plot No. C-3 & C-4 Value
manufacturer / Applicant Addition City, Faisalabad
Brand Name +Dosage Form + Triquin Cream 4%
Strength
Hydroquinone…….4% (w/w)
PKR 20,000/-: 31.10.2017
Pharmacological Group Other dermatologicals
Type of Form Form 5
Authorities.
Me-too status Safoquin Cream 4% by Saffron Pharmaceuticals. Reg. No. 46440
GMP status The firm has been granted DML on the basis of inspection dated
03.07.2018
Previous decision The board in its 287th meeting, deferred the case for evidence of
approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in
its 275thmeeting.
Evaluation by PEC  CORRECTOR 4 (hydroquinone 4% w/w) cream. Health
Canada approved
Decision:
Evaluator PEC-XII
981. Name and Address of Manufacturer / Dynatis Pakistan Pvt Ltd.
Applicant Plot No.710, Sundar Industrial Estate, Raiwind Road,
Lahore
Brand Name + Dosage Form + Strength Dylox 30mg Capsule
Dated 26-12-2018
Composition Each hard gelatin Contains:
Enteric coated Pellets of Duloxetine hydrochloride
equivalent to Duloxetine (20%w/w)…30 mg
Type of Form Form 5
Pack Size & Demanded Price 10’s / As per SRO
Approval Status of Product in Reference Duloxetine 30 mg gastro-resistant capsules By Tillomed
Regulatory Authorities. Laboratories Ltd. (MHRA Approved.)
Me-too Status SYMPTA Capsules by M/s Polyfine Chempharma (Pvt,)
Ltd. (Reg.# 078462)
GMP Status Inspection dated 04-12-2018 recommends grant of DML.
Remarks of the Evaluator.  Source of pellets:
Alphamed formulations Private Limited,
Address: Survey no. 225, Sampanbole Village, Shamirpet
Mandal, Medchal-Malkajgiri District-500 078,
Telangana, India.
 Firm has not submitted differential fee for import of
pellets.
Previous decision Registration Board in its 287th meeting deferred the case
for the following reason:
Deferred for submission of differential fee of Rs. 80,000/-
for import of pellets.
Evaluation by PEC  Firm has submitted COA of pellets from
manufacturer.
 Firm has submitted stability study data of pellets
conducted as per Zone IV-A conditions.
 Firm has submitted differential fee of Rs. 80,000/- for
import of pellets.(Challan#0810758)
Decision:
Lahore
Dated 27-12-2018
Enteric coated Pellets (17%) of Duloxetine hydrochloride
equivalent to Duloxetine…20 mg
Type of Form Form 5
Approval Status of Product in Reference Cymbalta (Duloxetine 20 mg capsule) by M/s Eli Lilly,
Me-too Status Dulan (Duloxetine 20 mg capsule) by M/s Hilton
Pharma.(Reg#055446)
Telangana, India.
pellets.
manufacturer.
Decision:
Lahore
Brand Name + Dosage Form + Strength Temolin 0.4mg Capsule
Dated 26-12-2018
Tamsulosin hydrochloride (as extended release pellets
0.2%w/w)………. 0.4mg
Pharmacological Group Drugs used in benign prostatic hypertrophy (Alpha-
adrenoreceptor antagonists)
Type of Form Form 5
Approval Status of Product in Reference Galebon 0.4 mg prolonged-release hard capsules of M/s
Regulatory Authorities. Consilient Health Limited (MHRA Approved)
Me-too Status M-Sol 0.4mg Capsule of M/s Regal Pharmaceuticals
(Reg.#081977)
Telangana, India.
pellets.
manufacturer.
Decision:
Lahore
Dated 27-12-2018
Enteric coated Pellets (17%) of Duloxetine hydrochloride
equivalent to Duloxetine…60 mg
Type of Form Form 5
Approval Status of Product in Reference Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly,
Me-too Status Swenta 60mg Capsule by M/s Martin Dow (Reg#070784)
Telangana, India.
pellets.
manufacturer.
Decision:
Lahore
Brand Name + Dosage Form + Strength O-Fit 120mg Capsule
Dated 27-12-2018
Orlistat (IR Pellets 50%) ……120mg
Pharmacological Group Peripherally acting antiobesity products
Type of Form Form 5
Approval Status of Product in Reference Orlistat 120 mg capsules, hard by M/s TEVA UK
Me-too Status Osker 120mg Capsule by M/s Genix (Reg#066788)
Remarks of the Evaluator.  Registration board deferred the formulation for
clarification of the composition of pellets in its 284th
meeting.
 Source of pellets not submitted by the firm.
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  Source of pellets:
Telangana, India.
 Firm has submitted COA of pellets from
manufacturer.
Decision:
Lahore
Brand Name + Dosage Form + Strength Xolim 40mg Sachet
Dated 27-12-2018
Esomeprazole as Esomeprazole magnesium trihydrate
(enteric coated pellets 22.5%w/w) …40mg
Type of Form Form 5
Finished Product Specification Manufacturer specifications
Pack Size & Demanded Price 5’s, 10’s / As per SRO
Approval Status of Product in Reference NEXIUM (esomeprazole magnesium) for delayed-release
Regulatory Authorities. oral suspension (unit dose packet) by AstraZeneca
Pharmaceuticals LP (USFDA Approved)
Me-too Status Esowin Plus 40mg Sachet of M/s Winthrox
Pharmaceuticals, Karachi. (Reg.# 081519)
Telangana, India.
pellets.
manufacturer.
Decision:
M/s Hamaz Pharmaceuticals (Pvt.) Ltd, 13-km, Lutafabad, Bosan Road, Multan
Firm applied for registration of 19 products against their Liquid Injectable (Ampoule/Vial) (General and
General Antibiotics section). In the inspection report of the firm, ampoule and vials filling rooms and
equipment being mentioned but Licensing Division issued letter for one section for the two separate
sections.
As per policy, registration Board considered only 10 products per new section. The 19 applications were
placed before the board and the board deferred for clarification from Central Licensing Board regarding
separate section for ampoule and vials.
On 17th November 2015, the firm has submitted a request for consideration of their case again in and given
priority of 10 products out of 19.
987. Name and address of Manufacturer / M/s. Hamaz Pharmaceuticals (Pvt.) Ltd;
Applicant 13 km, Bosan road, Lutfabad, Multan
Brand Name +Dosage Form +Strength Spizole IV Infusion 500mg/100ml
Composition Each 100 ml vial contains
Metronidazole …500mg
Diary No. Date of R&I & fee Rs. 20,000/- vide Dy. No. 4810 dated 04-08-2015
Pharmacological Group Quinolone Antibiotics
Type of Form Form-5
Pack Size & Demanded Price Pack of 1 x 100 ml/ price 78.
Approval status of product in Reference METROZINE metronidazole 500mg in 100mL injection
Regulatory Authorities vial by M/s Proqualix Pty Ltd (TGA Approved)
Me-too status Anarob Injection 500mg/100ml by M/s Global
(Reg#026985)
GMP status Certificate of last, GMP Inspection dated 01.08.2017 with
cGMP compliance.
Previous Decision Registration Board in its 253rd meeting deferred the case
Deferred for clarification from Central Licensing Board
regarding separate section for ampoule and vials.
Evaluation by PEC  The firm has requested Registration board to consider
the applied formulations on its turn basis.
 Firm has the following section:
Liquid Injectable (Ampoule/Vial) (General and General
Antibiotics)
Decision:
Brand Name +Dosage Form +Strength Flikz IV Infusion 100mg/50ml
Fluconazole …100mg
Pharmacological Group Antifungal Trizole
Type of Form Form-5
Approval status of product in Reference DIFLUCAN fluconazole 100mg/50mL injection vial by
Regulatory Authorities M/s Pfizer (TGA Approved_
Me-too status Syncon Infusion IV 100mg/50ml by M/s Synchro
(Reg#083374)
cGMP compliance.
Antibiotics)
Decision:
Brand Name +Dosage Form +Strength Flacin IV Injection 600 mg/2ml
Composition Each Vial 02 ml contains
Lincomycin (as hydrochloride) …600mg
Pharmacological Group Lincosamide
Type of Form Form-5
Pack Size & Demanded Price Pack of 1 x 02 ml vials / price 55.
Approval status of product in Reference LINCOCIN 600mg/2mL injection vial by M/s Pfizer
Regulatory Authorities Australia Pty Ltd (TGA Approved)
Me-too status LINCOMYCIN 600MG INJ (vial) by M/s Conagent
(Reg#006065)
cGMP compliance.
Antibiotics)
Decision:
Brand Name +Dosage Form +Strength I-MOX IV Infusion 400 mg/250ml
Moxifloxacin (as hydrochloride) …400 mg
Type of Form Form-5
Pack Size & Demanded Price Pack of 1 x 250 ml vials / price 1250.
Approval status of product in Reference AVELOX IV 400 moxifloxacin 400 mg/250 mL (as
Regulatory Authorities hydrochloride) intravenous infusion solution bottle by
M/s Bayer Australia Ltd (TGA Approved)
Me-too status Izilon I.V Infusion 400mg/250ml by Bosch
(Reg#030074)
cGMP compliance.
Antibiotics)
 Firm does not have relevant section to
manufacture applied product
Decision:
Brand Name +Dosage Form +Strength Gastid Injection 50mg/2ml
Composition Each ampoule (2 ml) contains
Ranitidine (as hydrochloride) …50 mg
Pharmacological Group H2 Blocker
Type of Form Form-5
Pack Size & Demanded Price MRP. Rs 110.56 for 05 Ampoule
Approval status of product in Reference ZANTAC 50mg/2mL injection ampoule by M/s Aspen
Regulatory Authorities Pharmacare Australia Pty Ltd (TGA Approved)
Me-too status ULCEMED I.M / I.V INJECTION 50MG / 2ML by M/s
MEDICEENA (Reg#023104)
cGMP compliance.
Antibiotics)
Decision:
Brand Name +Dosage Form +Strength Nitid Injection 50mg/2ml
Composition Each ampoule (2ml) contains
Pheniramine Maleate 50 mg equivalent to Pheniramine
Salicylate 45.4 mg
Pharmacological Group Arylakylamine
Type of Form Form-5
Pack Size & Demanded Price MRP. Rs 500 for 50 x 02 ml Ampoule
MRP Rs 1211 per 100 x 02 ml
Approval status of product in Reference International availability not confirmed
cGMP compliance.
Antibiotics)
 Approval status of product in Reference Regulatory
Authorities not confirmed
 Me-too status not confirmed from available database.
Decision:
Brand Name +Dosage Form +Strength M.B Vit Injection 500 mcg/ml
Composition Each ampoule (1 ml) contains
Mecobalamin…500 mcg
Diary No. Date of R&I & fee Coenzyme Type Vitamin B12
Pharmacological Group Rs. 20,000/- vide Dy. No. 4836 dated 04-08-2015
Type of Form Form-5
Finished Product Specification Manufacture Specification
Pack Size & Demanded Price MRP Rs 814 per 10 Ampoules
Approval status of product in Reference Methycobal (ampoule)of M/s Eisai Company Ltd
Regulatory Authorities (PMDA Japan Approved)
Me-too status METHYCOBAL INJECTION 0.5mg/ml of M/s
PROGRESSIVE ASSOCIATE (Reg#010313)
cGMP compliance.
Antibiotics)
Decision:
Brand Name +Dosage Form +Strength Vialox IV Infusion 200mg/100ml
Ofloxacin hydrochloride 220 mg eq to Ofloxacin 200 mg
Pharmacological Group Quinolone Antibiotics
Type of Form Form-5
Approval status of product in Reference Tarivid® 200mg/100ml Solution for Infusion (Vial) by
Regulatory Authorities M/s Sanofi-Aventis (MHRA approved)
Me-too status Adios Injection 200mg/100ml by M/s Wilshire
(Reg#032350)
cGMP compliance.
Antibiotics)
 Firm has applied as Ofloxacin (as hydrochloride)
…200 mg ,whereas, formulation approved in
MHRA is Ofloxacin …200 mg
Decision:
Brand Name +Dosage Form +Strength Linor IV Injection 200 mg/100ml
Composition Each 100 ml contains
Linezolid …200mg
Pharmacological Group Oxazolidinone, Antibiotic
Type of Form Form-5
Finished Product Specification Manufacture Specification
Pack Size & Demanded Price Pack of 1 x 100 ml vial /price 346.
1 x 200 ml vial/ price 400
1 x 300 ml vial / Price 600
Approval status of product in Reference FDA approved Linezolid (Sandoz)
Me-too status Zolrest 200mg / 100ml Infusion by M/s Bosch
(Reg#055914)
cGMP compliance.
Antibiotics)
Decision:
Case No. 04: Registration applications for local manufacturing of (veterinary) drugs
a. New cases
Evaluator PEC-IV
996. Name and address of M/S Intervac (Pvt) Ltd., 18-Km, Lahore Sheikhupura
manufacturer / Applicant Road, Sheikhupura, Pakistan
Brand Name +Dosage Form + Oxytofas- DS Injection
Strength
Composition Each 100ml powder contains:
Oxytocin ( Synthetic)……….2000IU
Pharmacological Group Hormone
Type of Form Form 5
Pack size & Demanded Price 50ml; Decontrolled
Me-too status (with strength and Oxytovet Injection Of M/S International Pharma Labs.
dosage form)
GMP status Last inspection conducted on 28-02-2017 & 17-03-2017
and report concludes that panel recommend the renewal of
injectable section (veterinary) and vaccines section
(veterinary).
Decision:
997. Name and address of M/S Intervac (Pvt) Ltd., 18-Km, Lahore Sheikhupura
manufacturer / Applicant Road, Sheikhupura, Pakistan
Brand Name +Dosage Form + Oxytofas- DS Injection
Strength
Composition Each 100ml powder contains:
Oxytocin ( Synthetic)……….2000IU
Pharmacological Group Hormone
Type of Form Form 5
Pack size & Demanded Price 100ml; Decontrolled
Me-too status (with strength and Oxytovet Injection Of M/S International Pharma Labs.
dosage form)
GMP status Last inspection conducted on 28-02-2017 & 17-03-2017
and report concludes that panel recommend the renewal of
injectable section (veterinary) and vaccines section
(veterinary).
Decision:
998. Name and address of M/s Nawal Pahrmaceuticals.
manufacturer / Applicant Plot No. 11-A, Punjab Small Industrial Estate,Taxila
Brand Name +Dosage Form + Multi-Wal Injection
Strength
Vitamin B1…5mg
Vitamin B2…2.5mg
Vitamin B6…2.5mg
Nicotinamide…37.5mg
02-2018
Pharmacological Group Multivitamin
Type of Form Form 5
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml ; Decontrolled
Me-too status (with strength and Vitamin B Complex Of M/S Amros Pharmaceuticals
dosage form)
GMP status Last inspection conducted on 10-10-2017 report concludes
that overall evalution of the inspection report is good
Decision:
Brand Name +Dosage Form + Keto-Wal Injection
Strength
Ketprofen BP…100mg
02-2018
Type of Form Form 5
Me-too status (with strength and Ketoshell Injection Of M/S. Inshal Pharmaceutical
dosage form)
Decision:
Brand Name +Dosage Form + GCD-Wal Injection
Strength
Gentamicin suplhate BP…5g
Colistin Sulpahte BP…50 MIU
Dihydrostreptomycin Sulphate BP…10g
02-2018
Type of Form Form 5
Finished product Specifications Manufacturer’s specificaton
Me-too status (with strength and Tg-65 Injection Of M/S Attabak Pharmaceutical
dosage form)
Decision:
Brand Name +Dosage Form + GTS-MIX Injection
Strength
Gentamicin Sulpahte BP…30mg
Trimethoprim BP…25mg
Sulfadimidine…125mg
02-2018
Type of Form Form 5
Finished product Specifications Manufacturer’s specificaton
Me-too status (with strength and Alfacin Plus Injection. Of M/S Alina Combine
Decision:
Brand Name +Dosage Form + Bersen-Wal Injection
Strength
Trimethoprim BP…80mg
Sulfadiazine BP…400mg
02-2018
Type of Form Form 5
Me-too status (with strength and Trimdiazine Injection Of M/S Elko Organisation
dosage form)
Decision:
Brand Name +Dosage Form + Nitrox-200 Injection
Strength
Nitroxynil BP…200mg
02-2018
Type of Form Form 5
Finished product Specifications Manufacuture specification
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml :Decontrolled
Me-too status (with strength and Nitoxil-20% Injection Of M/S Star Laboratories
dosage form)
Decision:
Brand Name +Dosage Form + Meloxi-Wal Injection
Strength
Meloxicam BP…10mg
02-2018
Type of Form Form 5
Me-too status (with strength and Meloxi-10 Injection Of M/S Selmore
Decision:
Brand Name +Dosage Form + Davo Injection
Strength
Diminazene aceturate…105mg
Antipyrine BP…131mg
Vitamin B12 BP…4mg
02-2018
Pharmacological Group Antihelmentic, vitamin
Type of Form Form 5
Finished product Specifications Manufactures specification
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml:Decontrolled
Me-too status (with strength and Dipyrene Plus Injection Of M/ Breeze Pharma
dosage form)
GMP status Last inspection conducted on 10-10-2017 report
concludes that overall evalution of the inspection report is
good
Decision:
Brand Name +Dosage Form + Nitrox-340 Injection
Strength
Nitroxynil BP…340mg
02-2018
Type of Form Form 5
Finished product Specifications Manufacuture specification
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml :Decontrolled
Me-too status (with strength and Nixil Injection. Of M/S Hilton Pharma (Pvt) Ltd.
dosage form) Karachi. .
Decision:
Brand Name +Dosage Form + Dipyrine Injection
Strength
Diminazene aceturate…105mg
Antipyrine BP…131mg
02-2018
Pharmacological Group Anthelmentic, Vitamin
Type of Form Form 5
Me-too status (with strength and Diamin Plus Injection. Of M/S Alina Combine
dosage form) Pharmaceutical
Decision:
Brand Name +Dosage Form + IVO-Super Injection
Strength
Ivermectin (USP)…10mg
Clorsulon (USP)…100mg
02-2018
Pharmacological Group Anthelmintic
Type of Form Form 5
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml: Decontrolled
Me-too status (with strength and Ivoron Super Injection Of M/S Breeze Pharma
dosage form) Islamabad
Decision:
Brand Name +Dosage Form + Floxacin-10% Injection
Strength
Enrofloxacin BP…100mg
02-2018
Type of Form Form 5
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml Decontrolled
Me-too status (with strength and El-Floxacin Injection Of M/S Elko
dosage form) Organisation Karachi
Decision:
Evaluator PEC-V
1010. Name and address of Manufacturer D-Maarson Pharmaceuticals Plot # 17, Street SS-2,
/ Applicant National Industrial Zone, Rawat
Brand Name, Dosage Form, Strength LICOSON Oral W/S Powder
Composition Each g contains:-
Lincomycin HCl……………100mg
Colistin sulphate …………. 800,000IU
Diary No., Date of R & I & Fee Dy.6438, 21/02/2018, Rs.20,000
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100gm,250gm,500gm,1Kg,5Kg,10Kg,25Kg /
Decontrolled
Approval Status of Product In Reference N/A
Me-Too Status 016204
Lincocol-W/S Powder
M/S International Champharma Lahore
GMP Status GMP Inspection conducted on 14/12/2017. Good
Decision
Brand Name, Dosage Form, Strength FON-MAARS Oral W/S Powder
Composition Each 100g contains:-
Oxytetracycline HCl …………. 300mg
Florfenicol ……………………. 100mg
Neomycin Sulphate …………… 150mg
Type Of Form Form 5
Decontrolled
E-Col Water Soluble Powder
M/s. Evergreen Pharmaceuticals, Lahore.
Decision
Brand Name, Dosage Form, Strength DT-60 Oral W/S Powder
Doxycycline HCl ………….…… 40g
Tylosin tartrate ………….…….. 20g
Type Of Form Form 5
Decontrolled
M Kill-TD Water Soluble Powder
M/s Biogen Pharma, Rawat Chak Beli Road, Rawat.
Decision
Brand Name, Dosage Form, Strength D-ZINE Oral W/S Powder
Composition Each g contains:-
Piperazine Citrate …….…… 1000mg
Pharmacological Group Antiparasitics
Type Of Form Form 5
Decontrolled
Piperapure-1000 Water Soluble Powder.
By Attabak Pharmaceutical Industries, Islamabad.
Decision
Brand Name, Dosage Form, Strength DINESON Oral W/S Powder
Amantadine HCl ………………………98g
Pharmacological Group Anti-Viral
Type Of Form Form 5
Decontrolled
EMANTA-98 ORAL POWDER
M/s. Evergreen Pharmaceuticals,
69-70/B, Main Glaxo Town, Industrial Area, 20th Km
Ferozpur Road, Lahore.
Decision
Brand Name, Dosage Form, Strength ECIDINE 10% Oral W/S Powder
Amantadine HCl ………………………10g
Pharmacological Group Anti-Viral
Type Of Form Form 5
Decontrolled
Amantabak 10% Powder
"M/S. Attabak Pharmaceuticals,
Plot # 5c, I-10/3, Industrial Area, Islamabad."
Decision
Brand Name, Dosage Form, Strength NEO-MAARS Oral W/S Powder
Neomycin Sulphate ……………72g
Type Of Form Form 5
Decontrolled
Velle Neomycin W.S. Powder.
By M.S K&K PHARMACEUTICALS, LAHORE
Decision
Evaluator PEC-I
1017. Name
1 and address of manufacturer M/s RAS Pharmaceutical (pvt) ltd. Qadirpir Raan
Bypass Near Shalimar Petrolium 25km, Multan.
Brand Name +Dosage Form + Strength AMPRO C-50 Oral Powder
Diary No. Date of R& I & fee Diary No:19403, 30-10-2017 , Rs: 20,000/-
Composition Each gram contains: -
Amprolium HCl………………………….…500mg
Pharmacological Group Anti-bacterial
Type of Form Form-5
Pack size & Demanded Price As per policy of DRAP.
Me-too status BIO-AMP 50% POWDER (Reg.# 023410)
GMP status Date of Inspection: 16-10-2018
The firm is a small manufacturing unit (veterinary) and
was operating at the fair level of GMP compliance.
However it is advised to overcome the shortcomings and
submit the compliance accordingly.
Decision:
1018. Name
2 and address of man M/s RAS Pharmaceutical (pvt) ltd. Qadirpir Raan
Bypass Near Shalimar Petrolium 25km, Multan
Brand Name +Dosage Form + Strength DIANIL Oral Suspension
Composition Each 1ml contains: -
a. Sulphadiazine ………………….35.5mg
b. Sulphadimidine ………………...28.4mg
c. Neomycin Sulphate………….…...1.8mg
d. Hyoscine Methylbromide ….…...0.04mg
e. Kaolin……………….…………103.3mg
f. Pectin ……..…………………… 7.10mg
g. Vitamin B1 ……………………..0.15mg
h. Vitamin B2 ……………………..0.22mg
Pharmacological Group Anti-biotic + Vitamins
Type of Form Form-5
Finished Product Specification Manufacturer’s specs.
Me-too status Peclin-S Oral Suspension. (Reg.# 035132)
Decision:
1019. Name
Brand Name +Dosage Form + Strength LINCORAS 11 Feed Premix Powder
Composition Each 1kg powder contains: -
Lincomycin HCl……………….….. 11gm
Type of Form Form-5
Me-too status JFLINCON ORAL POWDER. (Reg.# 043245)
Decision:
1020. Name
Brand Name +Dosage Form + Strength RENOTON Powder
Composition Each 100g contains: -
a. Ammonium Chloride………………. .45gm
b. Magnesium Sulphate…………………25gm
c. Sodium Sulphate……………………...25gm
d. Sorbitol……………………………….5.0gm
Pharmacological Group Feed Supplements as Diuretic
Type of Form Form-5
Me-too status RENAL PLUS POWDER (Reg.# 043174)
Decision:
1021. Name
th
| 463
Brand Name +Dosage Form + Strength DIGESTON Feed Premix Oral Powder
Composition Each 100g powder contains: -
Olaquindox……………………….…. 10gm
Pharmacological Group Growth Promotor
Type of Form Form-5
Me-too status OLANDOX POWDER (Reg.# 022151)
Decision:
Evaluator PEC-VI
1022. Name and address of manufacturer / M/s Ras Pharmaceuticals Pvt Ltd, 25km, Lahore
Applicant road, multan
Brand Name +Dosage Form + Strength Florowan-25 Oral Liquid
Florfenicol ……25gm
Type of Form Form-5
Finished product Specification Manufacurer’s Specification
Pack size & Demanded Price 100ml, 200ml, 500ml, 1 Liter, 5 Liter, 25Liter
Decontrolled
Me-too status NOBIFLOR 25% LIQUID Reg # 063639
GMP status  16-10-2018 Firm was operating at the fair level
of GMP Compliance.
Remarks of Evaluator Fee challan Photocopy attached.
Decision:
Brand Name +Dosage Form + Strength Coliran 25% Oral Solution
Colistin Sulphate……25gm
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)
of GMP Compliance.
Me-too status could not be confirmed.
Decision:
Brand Name +Dosage Form + Strength Coliwan Oral Solution
Colistin Sulphate……20gm
Type of Form Form-5
Decontrolled
Me-too status Colibiotic by Guytton Pharma Reg no # 034573
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength Quinocin 25% Oral Liquid
Enrofloxacin……25gm
Type of Form Form-5
Decontrolled
Me-too status Flunix Liquid by Lead Pharma Islamabad Reg #
046657
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength Bromowan 5% Oral Liquid
Bromhexine HCl……5gm
Pharmacological Group Mucolytic
Type of Form Form-5
Decontrolled
Me-too status Bromofos by Intervac Pharma Reg # 057108
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength R-Encoras Oral Solution
Enrofloxacin……10gm
Colistin Sulphate…..50 M IU
Type of Form Form-5
Finished product Specification In-House
Decontrolled
Me-too status Encoras Oral Solution by Zakfas Pharma Multan Reg
# 057067
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength Hepavit Super Oral Liquid
Carnitine…..2500mg
Methionine…..1000mg
Choline Chloride….1900mg
Magnesium Sulphate….1000mg
Sorbitol…..20,000mg
Type of Form Form-5
Decontrolled
Me-too status Hepasol Liquid by Intervac Reg # 069657
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength Florax -C Oral Liquid
Florfenicol ..…..10gm
Colistin Sulphate……50MIU
Type of Form Form-5
Decontrolled
Me-too status FLORO-C ORAL LIQUID Reg # '074079
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength Enro-C Oral Solution
Enrofloxacin….20gm
Colistin Sulphate….50 MIU
Type of Form Form-5
Decontrolled
Me-too status COL-EN 70 LIQUID Reg # 075691
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength Coli T-30 Oral Powder
Composition Each 100gm contains:
Colistin Sulphate….30gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1kg, 2.5kg, 5kg, 25kg, Decontrolled
Me-too status Coli-cure 30% by Westmont Pharma Reg # 071002

of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength RZL-150 Fee Premix Powder
Composition Each 1kg contains:
Zinc Bacitracin……100gm
Lincomycin (Lincomycin as HCl)…..50gm
Type of Form Form-5

Me-too status ZL-150 by Intervac Reg # 069663
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength SS-30 Oral Powder
Sulphaclozine Sodium……30%
Type of Form Form-5

Me-too status ESb3 by Hilton Pharma (Could not be confirmed)
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength R ONC-154 Oral Powder
Oxytetracycline HCl…..8gm
Neomycin Sulphate….7gm
Colistin Sulphate….0.4gm
Type of Form Form-5

Me-too status ONC-154 by Intervac Pharma Reg # 071035
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength D-50 Oral Powder
Doxycycline HCl…..50gm
Type of Form Form-5

Me-too status Seldox Powder by Selmore Reg # 058717

of GMP Compliance.
Me-too product contains Doxycycline Hyclate.
Decision:
Brand Name +Dosage Form + Strength TCD-35 Oral Powder
Tylosin tartrate……10gm
Doxycycline HCl….20gm
Colistine Sulphate….45 MIU
Bromhexine HCl….4gm
Type of Form Form-5

Me-too status CD Ras Powder by Zakfas Pharmaceuticals(Could not
be confirmed)
of GMP Compliance.
Decision:
Brand Name +Dosage Form + Strength RCD-RAS Oral Powder
Tylosin tartrate……10gm
Doxycycline HCl….20gm
Colistine Sulphate….5gm
Bromhexine HCl…..0.5gm
Type of Form Form-5

Me-too status CD Raas Powder by Zakfas Pharmaceuticals Reg #
057072
of GMP Compliance.
Me-too product contains Doxycycline Hyclate.
Decision:
1038. Name and address of manufacturer / M/s Sanna laboratories, 1019-B, Sargodha road,
Applicant Faisalabad
Brand Name +Dosage Form + Strength Broncodox-Forte (Oral Water Soluble Powder)
Tylosin Tartarate….20gm
Doxycycline HCl……40gm
Colistin Sulphate…..10gm
Bromhexine HCl…..2gm
Diary No. Date of R& I & fee Dy. No. 51; 11-07-2017 ; Rs.20,000/- (10-07-2017)
Type of Form Form-5
Finished product Specification Innovators Specification
Pack size & Demanded Price 100gm, 300gm, 500gm, 1Kg, 5Kg, 10Kg, 25Kg
Decontrolled
Me-too status Brocotyd by Univet Pharmaceutical, Rawalpindi Reg
# 058962
GMP status Panel inspection report conducted on 04-07-2017 for
grant of GMP certificate concluding fair level of
compliance with GMP guidelines.
Remarks of Evaluator Me-too product contains Doxycycline Hyclate
Decision:
1039. Name and address of manufacturer / M/s Star laboratories, 23 KM- Multan road, Lahore.
Applicant
Brand Name +Dosage Form + Strength Kolivet Injection 50ml
Amoxcillin as Trihydrate….100mg
Colistin Sulphate……250,000 IU
Type of Form Form-5
Pack size & Demanded Price 50ml, Decontrolled

Me-too status Colimoxin BY Selmore reg # 034576
GMP status 27-10-2016 In general GMP Compliance was found good
as per guidelines laid down under schedule B and B-II.
Decision:
Applicant
Brand Name +Dosage Form + Strength TYZ injection 50ml

Gentamycin Sulphate…..100mg
Tylosin Tartarate….50mg
Type of Form Form-5

Me-too status B.G. GENTA INJECTION Reg # 075624
Decision:
Applicant
Brand Name +Dosage Form + Strength Ktex injection 50ml

Amoxicillin (as Amoxicillin trihydrate)….140mg
Clavulanic acid (as Potassium Clavulanate)…35mg
Type of Form Form-5

Me-too status Clavet Injection Reg # 046519
Decision:
Applicant
Brand Name +Dosage Form + Strength Ivotek DS injection 50ml

Ivermectin…20mg
Pharmacological Group Antiparasitic
Type of Form Form-5

Me-too status ZAMEC INJECTION. Reg # 046535
Decision:
Applicant
Brand Name +Dosage Form + Strength Ivotek DS injection 10ml

Ivermectin…20mg
Type of Form Form-5

Me-too status ZAMEC INJECTION. Reg # 046535
Decision:
Evaluator PEC-VII
1044. Name and address of manufacturer / M/s A & K pharmaceuticals 94-A Punjab small
Applicant industraial estae Sargodha road Faisalabad.
Brand Name +Dosage Form + Strength Quinak Bolus
Diary No. Date of R& I & fee Form-5 Dy.No 3680 dated 29-01-2018 Rs. 20,000 Dated
29-01-2018
Composition Each Bolus Contains:
Flumiquine…0.35 grams
Cattle, sheep and goat
Type of Form Form-5
Finished Product Specification In house
Pack Size & Demanded Price 5’s, 10’s,20’s, 50’s,100’s
Decontrolled
Me-too Status FLUMIQUIN BOLUS by leads (043585)
operating at satisfactory compliance with GMP
guidelines as of today
Decision:
1045. Name and address of manufacturer / M/sA & K pharmaceuticals 94-A Punjab small
Brand Name +Dosage Form + Strength Moxis-20 Powder
29-01-2018
Composition Each 100 gm ontains:
Amoxicillin Trihydrate…20 g
Cattle, sheep and goat
Type of Form Form-5
Pack Size & Demanded Price 28 gm,100 gm, 200 gm,
Decontrolled
Me-too Status AMOXICILLIN 20% SUSPENSION (057155)
Decision:
Brand Name +Dosage Form + Strength Colmox-23 powder
29-01-2018
Composition Each 100 gm contains:
Ampicillin as Trihydrate…23 g
Colstin Sulphate…100 MIU
Type of Form Form-5

Pack Size & Demanded Price 28 gm,100 gm, 200 gm,
Decontrolled
Me-too Status COLI-A POWDER by Gutoyn (044941)
Decision:
Applicant industrial estae Sargodha road Faisalabad.
Brand Name +Dosage Form + Strength Levanew- 300 bolus
29-01-2018
Composition Each bolus contains:
Levamisole HCL…0.3 grams
Live stock
Type of Form Form-5
Pack Size & Demanded Price 5, 10,20,50 and 100’s (4.90 gm bolus)
Decontrolled
Me-too Status Leva 300 Bolus (Intervac) 073987
Decision:
Brand Name +Dosage Form + Strength Zisco-AK Bolus
29-01-2018
Copper…0.1604 grams
Cobalt…0.0032 grams
Selenium…0.0032 grams
Zinc…0.1443 grams
Iodine…0.0171 grams
Dairy cattles
Type of Form Form-5
Pack Size & Demanded Price 5, 10,20,50 and 100’s
Decontrolled
Me-too Status NA
Remarks of the Evaluator VII Me too not available
Decision:
Brand Name +Dosage Form + Strength Clopinol-500 Bolus
29-01-2018
Composition Each bolus ontains:
Closantel…0.5 grams
Dairy cattles
Type of Form Form-5
Pack Size & Demanded Price 5, 10,20,50 and 100’s (5.1 gm bolus)
Decontrolled
Me-too Status FLUKINIL BOLUS (046571)
Decision:
Brand Name +Dosage Form + Strength Levoxazole Bolus
29-01-2018
Oxyclozanide…2.25 grams
Levamisole HCL…1.125 grams
Pharmacological Group Anthelmentic
Cattle, Sheep and goat
Type of Form Form-5
Pack Size & Demanded Price 10, 20,50 and 100’s (8.025 gm bolus weight)
Decontrolled
Me-too Status VERMICIDE BOLUS by Biolabs (034565)
Decision:
Brand Name +Dosage Form + Strength Parazole-200 Granules
29-01-2018
Albendazole…200 mg
Pharmacological Group Anthelmentic
Cattle, Sheep and goat
Type of Form Form-5
Pack Size & Demanded Price 10, 20,50 and 100’s
Decontrolled
Me-too Status ALVENAX GRANULES by star labs (026581)
Decision:
Brand Name +Dosage Form + Strength LS-Amoxi Powder
29-01-2018
Amoxicillin Trihydrate…0.2kg
Spectinomycin 2HCL…0.08kg
Lincomycin HCL…0.08kg
Vitamin E Acetate…0.03kg
Poultry
Type of Form Form-5
Pack Size & Demanded Price 100, 200, 250, 500, 1000, 5kg, 2.5 kg, 15 kg, 10 kg, 25
kg
Decontrolled
Me-too Status ASLE WATER SOLUBLE POWDER (079840)
Decision:
Brand Name +Dosage Form + Strength Strepen ZC-AK Powder
29-01-2018
Composition Each kg contains:
Procaine Penicillin…0.012kg
Zinc Bacitracin…0.052kg
Streptomycin Sulphate…0.036kg
Colistin Sulphate…0.003kg
Poultry
Type of Form Form-5
kg
Decontrolled
Me-too Status PRO SB-PLUS POWDER (028508)
Decision:
Brand Name +Dosage Form + Strength Strepen Z-AK Powder
29-01-2018
Procaine Penicillin…24 g
Zinc Bacitracin…104 g
Streptomycin Sulphate…72 g
Poultry
Type of Form Form-5
kg
Decontrolled
Me-too Status Polymycin Plus Powder By Star Labs (027493)
Decision:
Brand Name +Dosage Form + Strength Ampicolist-AK Powder
29-01-2018
Composition Each gram Contains:
Ampicillin as Trihydrate…200mg
Colstin Sulphate…600,000 IU
Calves and lambs
Type of Form Form-5
kg
Decontrolled
Me-too Status NA
Remarks of the Evaluator VII Me too evidence missing
Decision:
Brand Name +Dosage Form + Strength Pro-AK Powder
29-01-2018
Composition Each kg Contains:
Procaine Penicillin…12 g
Zinc Bacitracin…52 g
Streptomycin Sulphate…36 g
Poultry
Type of Form Form-5
kg
Decontrolled
Me-too Status NA
Remarks of the Evaluator VII Evidence of applied formulation/drug already approved
registration number, brand name and name of firm
Decision:
Brand Name +Dosage Form + Strength Tydox 30-BD Powder
29-01-2018
Composition Each Kg Contains:
Tylosin Tartrate…0.1kg
Doxycycline HCL…0.2kg
Bromhexine HCL…0.005kg
Dihydrostreptomycin…0.02kg
Poultry
Type of Form Form-5
kg
Decontrolled
Me-too Status NA
Remarks of the Evaluator VII Evidence of applied formulation/drug already approved
registration number, brand name and name of firm
Decision:
Applicant industrial estae Sargodha road Faisalabad.
Brand Name +Dosage Form + Strength Amoxiclave-200 Powder
29-01-2018
Composition Each g Contains:
Amoxicillin Trihydrate…160 mg
Clavulanic Acid…40 mg
Type of Form Form-5
kg
Decontrolled
Me-too Status CLAVET POWDER of salmore (034582)
Decision:
Brand Name +Dosage Form + Strength Moxis-50 Powder
29-01-2018
Composition Each 1000 gm contains:
Amoxicillin Trihydrate…500 g
Type of Form Form-5
kg
Decontrolled
Me-too Status Rymox-50 Water Soluble Powder. (069665)
Decision:
Evaluator PEC-XII
1060. Name and address of manufacturer / M/s Nawal Pahrmaceuticals.
Applicant Plot No. 11-A, Punjab Small Industrial Estate,Taxila
Brand Name +Dosage Form + Strength Bromo-Wal 50 Liquid
Dated 15-02-2018
Bromhexine hydrochloride …50mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml, 1litre, 2.5litre
/Decontrolled
Me-too status Bromomont Oral Liquid 5gm/100ml by M/s
Westmont Pharmaceutical (Reg#063742)
Renewal of DML
Firm is compliant to cGMP requirements.
Decision:
Brand Name +Dosage Form + Strength Nor-Col Oral Liquid
Dated 15-02-2018
Norfloxacin …20g
Colistin sulphate …60 MIU
Pharmacological Group Fluoroquinolone + Polymyxin (antibacterials)
Type of Form Form-5
/Decontrolled
Me-too status Coli-Nor Liquid by M/s LEADS PHARMA (PVT)
LTD (Reg#049501)
Renewal of DML
Firm is compliant to cGMP requirements.
Decision:
Brand Name +Dosage Form + Strength Bromo-Wal 10 Liquid
Dated 15-02-201
Composition Each ml Liquid Contains:
Bromhexine hydrochloride…10mg
Type of Form Form-5
/Decontrolled
Me-too status Brombak Oral Liquid by M/s Attabak Pharmaceutical
(Reg#058904)
Renewal of DML
Panel recommends renewal of DML.
Decision:
Brand Name +Dosage Form + Strength Nor-TS Oral Liquid
Dated 15-02-2018
Norfloxacin …10g
Sulfamethoxypyridazine …15g
Trimethoprim …3g
Pharmacological Group Combinations of antibacterials
Type of Form Form-5
/Decontrolled
Me-too status Norplus Liquid by M/s Attabak Pharmaceutical
(Reg#034534)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Sulpha-Wal Liquid
Dated 15-02-2018
Sulfadiazine …35.50mg
Sulfadimidine …28.40mg
Neomycin sulpahte …1.80mg
Hyoscine methylbromide…0.04mg
Pectin…7.10mg
Kaolin …103.30mg
Vitamin B1 …0.15mg
Vitamin B2 …0.22mg
Pharmacological Group Antidiarrheal combination / multivitamin
Type of Form Form-5
/Decontrolled
Me-too status Ever-X Suspension by M/s Evergreen Pharmaceuticals
(Reg#072691)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Tri-Wal SC Oral Suspension
Dated 15-02-2018
Triclabendazole…50mg
Levamisole hydrochloride …37.5mg
Cobalt sulphate…0.075g
Sodium selenite …0.035g
Type of Form Form-5
/Decontrolled
Me-too status FASINIL PLUS DRENCH by M/s SELMORE
PHARMCEUTICALS (PVT) LTD (Reg#035011)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Gumbo-Wal Powder
Dated 15-02-2018
Composition Each 100g contains:
Ammonium Chloride …70g
DL-Methionine …10g
Sorbitol …5g
Vitamin A …1,50,000 IU
Vitamin C …10g
Pharmacological Group Acidifier + diuretic
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1kg, 5kg, 10kg, 25kg /Decontrolled
Me-too status PERPHRON-N POWDER by M/s FARIM AID
GROUP (Reg#026513)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Colistin-50% Powder
Dated 15-02-2018
Colistin sulphate …500 MIU
Type of Form Form-5
Me-too status VELLE COLISTIN W.S. POWDER by M/s K&K
PHARMACEUTICALS (Reg#043590)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Amantadine 10% Powder
Dated 15-02-2018
Amantadine hydrochloride …10g
Pharmacological Group Anti-parkinson drugs
Type of Form Form-5
Me-too status ANTAMITS WATER SOLUBLE POWDER by M/s
WIMITS PHARMACEUTICALS (Reg#078316)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Pipera-Wal Powder
Dated 15-02-2018
Piperazine citrate …1000mg
Pharmacological Group Anthelmintics
Type of Form Form-5
Me-too status Pipra-Fa Powder by M/s Farm Aid Group
(Reg#026568)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Levamisole-50 Powder
Dated 15-02-2018
Composition Each 100gm Powder contains:
Levamisole hydrochloride …50g
Pharmacological Group Anthelmintics
Type of Form Form-5
Me-too status DEWORM WS POWDER by M/s ATTABAK
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength EN-Flox Powder
Dated 15-02-2018
Composition Each 100gm powder contains:
Enrofloxacin hydrochloride …20g
Type of Form Form-5
Me-too status ENROCIN POWDER by M/s ATTABAK
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Wal-Fone-C injection
Dated 13-02-2018
Calcium gluconate…20.83g
Magnesium hypophosphate…5.33g
Magnesium chloride…2.0g
Calcium D-Saccharate…1.0g
Boric Acid…4.33g
Dextrose anhydrous…20g
Pharmacological Group Minerals
Type of Form Form-5
Pack size & Demanded Price 10ml, 50ml, 100ml, 250ml, 500ml /Decontrolled
Me-too status Dicalfon-C Injection by M/s Mylabs (Reg#073912)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength LS-Wal Injection
Dated 13-02-2018
Spectinomycin (as hydrochloride) …100mg
Lincomycin (as hydrochloride) …50mg
Type of Form Form-5
Pack size & Demanded Price 10ml, 50ml, 100ml , 500ml /Decontrolled
Me-too status SPECTRAL INJECTION. by M/s BREEZE
PHARMA (Reg#059120)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Nixin-Wal Injection
Dated 13-02-2018
Flunixin meglumin …50mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-
steroids
Type of Form Form-5
Me-too status FLUMEG INJECTION by M/s Elko Organization
(Pvt) Ltd (Reg#029631)
Renewal of DML
Decision:
Brand Name +Dosage Form + Strength Wal-D Injection
Dated 13-02-2018
Calcium gluconate…20.83g
Magnesium hypophosphate…5.33g
Magnesium chloride…2.0
Calcium D-Saccharate…1g
Boric Acid…4.33g
Dextrose…20g
Vitamin B1…100mg
Vitamin B2…70mg
Vitamin B12…3000mcg
Nicotinamide…200mg
Pharmacological Group Mineral supplements
Type of Form Form-5
Renewal of DML
Remarks of the Evaluator.  Me-too status not confirmed from available
database.
Decision:
Evaluator PEC-XIII
1076. Name and address of manufacturer / M/s Biolabs (Pvt.) Limited, Plot # 145- Industrial
Applicant Triangle, Kahutta Road, Islamabad.
Brand Name +Dosage Form + Strength Biocolistin injection 20% (100ml)
Tylosin Tartrate …………….200mg
Pack size & Demanded Price 1x1 Vial of 100ml & As per PRC
Me-too status Tysin-200 Injection of M/s Epla Laboratories (Reg. #
026566)
GMP status GMP certificate granted based on inspection conducted
on 5th and 6th Dec, 2017.
Remarks of the Evaluator  Firm has liquid injection general (Vet) section as
is mentioned in the submitted section approval
letter.
Decision:
1077. Name and address of manufacturer / M/s Baariq Pharmaceuticals. Plot # 600, Sundar
Applicant Industrial Estate, Sundar Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Cyanoriq 1000 Injection
Cyanocobalamin…….1000mcg
Diary No. Date of R& I & fee Dy. No.7407 (27-02-2018) Rs. 20,000/- Dated 27-02-2018
Pharmacological Group Vitamin
Type of Form Form 5
Pack size 100ml
Me-too status Cyanocob-1000 injection of M/s Prix Pharma (Reg. #
074021)
compliance.
Decision:
Brand Name +Dosage Form + Strength Tylobar 20 Injection
Tylosin tartrate…200mg
Diary No. Date of R& I & fee Dy. No. 7411 (27-02-2018) Rs. 20,000/- Dated 27-02-
2018
Type of Form Form 5
Pack size 100ml
Approval status of product in Reference N.A
Me-too status Tylosan-20 injection of M/s Sanna Lab (Reg.# 027416)
compliance.
Decision:
Brand Name +Dosage Form + Strength Dine-98 Water Soluble Powder
Composition Each kg Powder contains:
Amantadine HCl…0.980KG
2018
Pharmacological Group Anti- Parkinson drug
Type of Form Form 5
Pack size 100gm, 250gm, 500gm, 1000gm, 2500gm, 5000gm,
10000gm, 25000gm
Me-too status Emanta-98 oral powder by Evergreen Pharma
Reg.#081735
compliance.
Decision:
Brand Name +Dosage Form + Strength Seleriq Injection
Vitamin E as Acetate…50mg
Sodium Selenite……...0.5mg
Diary No. Date of R& I & fee Dy. No 7413 (27-02-2018) Rs. 20,000/- (27-02-2018)
Pharmacological Group Vitamin with mineral
Type of Form Form 5
Pack size 100ml
Me-too status Pri-tolevit Plus SE injection by Prix Pharma (Reg.#
080760)
compliance.
Decision:
Brand Name +Dosage Form + Strength Ketoriq Injection
Ketoprofen…100mg
Rs. 20,000/- Dated 27-02-2018
Type of Form Form 5
Pack size 100ml
Me-too status Ketoflame-10 injection by Prix Pharma (Reg.# 080747)
compliance.
Decision:
Brand Name +Dosage Form + Strength GTRIQ Injection
Gentamycin sulphate…50mg
Tylosin tartrate…100mg
Rs. 20,000/- Dated 27-02-2018
Type of Form Form 5
Pack size 100ml
Me-too status G-Tylo injection by Vetz Pharma (Reg.# 079291)
compliance.
Decision:
Brand Name +Dosage Form + Strength Iverclor Injection
Ivermectin…10mg
Clorsulon…100mg
Rs. 20,000/- Dated 27-02-2018
Type of Form Form 5
Pack size 100ml
Me-too status Ivoshell super injection by Inshall Pharma (Reg.#
080523)
compliance.
Decision:
Brand Name +Dosage Form + Strength Hepariq Injection
Phenoxy-2 Methyl-2 Propionic Acid…100mg
Diary No. Date of R& I & fee Dy. No. 7405 dated 27-02-2018 Rs. 20,000/- Dated 27-02-
2018
Pharmacological Group Appetizer
Type of Form Form 5
Pack size 50ml
Me-too status Hepasel injection by Selmore Pharma (Reg.#046518)
compliance.
Decision:
Brand Name +Dosage Form + Strength Dorariq Injection
Doramectin…10mg
2018
Type of Form Form 5
Pack size 100ml
Me-too status Doramec injection by Leads Pharma (Reg.# 043580)
compliance.
Decision:
Brand Name +Dosage Form + Strength Enrobar-10 Injection
Enrofloxacin…100mg
Diary No. Date of R& I & fee Dy. No.7404 (27-02-2018) Rs. 20,000/-(27-02-2018)
Type of Form Form 5
Pack size 100ml
Me-too status Encure-10 injection by Nawan Lab (Reg.# 020803)
compliance.
Decision:
Brand Name +Dosage Form + Strength Mecclose Injection
Ivermectin…10mg
Closantel…125mg
2018
Type of Form Form 5
Pack size 100ml
Me-too status Ectin- C injection of M/s Decent Pharma (Reg.#
079170)
compliance.
Decision:
Brand Name +Dosage Form + Strength Oxfendbar Suspension
Oxfendazole………..22.65mg
Diary No. Date of R& I & fee Dy. No. 7409 (27-02-2018) Rs. 20,000/-(27-02-2018)
Type of Form Form 5
Pack size 100 ml,250ml,450ml,500ml,1000ml,2500ml,5000ml
Me-too status Oxasel Drench by SelmorePharma (Reg.# 071084)
compliance.
Remarks of the Evaluator XIII  Finished product monograph is available in
USP.
Decision:
Brand Name +Dosage Form + Strength Trimobar-S Injection
Sulphadiazine …400mg
Trimethoprim…80mg
Diary No. Date of R& I & fee Dy. No. 7410 (27-02-2018) Rs. 20,000/- (27-02-2018)
Type of Form Form 5
Pack size 100ml
Me-too status Santrin-50 injection by Sanna Lab (Reg.# 033270)
compliance.
Decision:
Brand Name +Dosage Form + Strength Florbar-30 Injection
Florfenicol…300mg
Diary No. Date of R& I & fee Dy. No. 7402 (27-02-2018) Rs. 20,000/- (27-02-2018)
Type of Form Form-5
Finished Product Specification In- house
Pack size 100ml
Me-too status Florofen injection of M/s Leads Pharma (Reg.# 043160)
compliance.
Decision:
Evaluator PEC-XIV
1091.Name and address of manufacturer / M/s Elko Organization Pvt Ltd.

Applicant Plot No.27 & 28, Sector 12-B, North Karachi,
Brand Name +Dosage Form + Strength Elko Cox Oral Liquid
Composition Each gm contains:
Toltrazuril…2.5% (25mg/ml)
Pharmacological Group Antiprotozoal agent
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 450ml, 500ml,1L,5L; Decontrolled
Me-too status Toltragen Oral Solution.by M/s Biogen Pharma
(Reg#049715)
GMP status Routine GMP inspection conducted on 13-06-2017 &
06-07-2017 concluded that the firm is operating at good
level of GMP compliance as of today.
Decision:
1092.Name and address of manufacturer / M/s Elko Organization Pvt Ltd., Plot No.27 & 28,
Applicant Sector 12-B, North Karachi, Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Elkoflor Oral Solution
Florfenicol…………….300mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 450ml, 500ml,1L,5L; Decontrolled
Me-too status MEDIFLOR 30% Oral Solution (Not confirmed)
level of GMP compliance as of today
Decision:
1093.Name and address of manufacturer / M/s Elko Organization Pvt Ltd., Plot No.27 & 28,
Applicant Sector 12-B, North Karachi, Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Elvomec-Tri Drench
Triclabendzole…………..120mg
Ivermectin………………2mg
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 450ml, 500ml, 1 L, 5 L; Decontrolled
Me-too status Thunder Drench of Star labs
level of GMP compliance as of today
Decision:
1094.Name and address of manufacturer / M/s Evergreen Pharmaceuticals, 69-70/B, Main
Applicant Glaxo Town, Industrial Area, 20th Km Ferozpur
Road, Lahore
Brand Name +Dosage Form + Strength Lincopec WS Powder
Composition Each Kg contains:
Lincomycin Hydrochloride………0.222Kg
Spectinomycin Hydrochloride………0.4447Kg
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, 2500gm;
Decontrolled
Me-too status Spectolin 100 of Baariq Pharma
GMP status Last inspection report 03-01-2018, panel decided to
recommend the renewal of DML.
Remarks of the Evaluator. The submitted me-too reference could not be verified
from available database.
Decision:
1095.Name and address of manufacturer / M/s Biogen Pharma, 8-Km Rawat Chak Beli Road,
Applicant Rawat
Brand Name +Dosage Form + Strength Selectozik IB Water Soluble Powder
Composition Each 1000gm contains:-
Tylosin Tartrate………….100gm
Doxycycline HCI………..200gm
Amantadione HCI………...40gm
Erythrocin………………...10gm
Diary No. Date of R& I & fee 364, 18-01-2011, 8000/-, 17-01-2011, 12000/-, 12-01-
2015
Pharmacological Group Antibiotic/ Antiviral
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml; Decontrolled
Me-too status Biosin TD of Leads Pharma
GMP status The firm has provided its latest inspection report
which was conducted on 18-08-2017 and it
concludes good level of GMP Compliance.
Remarks of the Evaluator. The submitted me-too reference could not be verified
from available database.
Decision:
1096.Name and address of manufacturer / M/s Biogen Pharma, 8-Km Rawat Chak Beli Road,
Applicant Rawat
Brand Name +Dosage Form + Strength B.G. Neo Oxyclor Oral Solution
Neomycin Sulphate………150gm
Oxytetracycline ………….300gm
Chloramphenicol………….300gm
Salicylic Acid…………….50gm
Ascorbic acid……………100gm
Diary No. Date of R& I & fee 422, 20-01-2011, 8000/-, 19-01-2011, 12000/-, 12-01-
2015
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml; Decontrolled
GMP status The firm has provided its latest inspection report
which was conducted on 18-08-2017 and it
concludes good level of GMP Compliance.
Remarks of the Evaluator. Me-too reference could not be verified.
Decision:
b. Deferred cases
Evaluator PEC-VIII
1097. Name and address of M/s. Decent Pharma plot # 30 Street St 3 National
manufacturer / Applicant Industrial Zone Rawat - Islamabad.
Brand Name +Dosage Form + Evomec Super Injection
Strength
Ivermectin ....10mg
Clorsulon…..100mg
Diary No. Date of R& I & fee Dy. No.1189,02-05-2017, 20,000/-, 28-04-2017
Pharmacological Group Anti-parasitic
Type of Form Form-5
Pack size & Demanded Price 50ml(i.m, subcut); Decontrolled
Authorities.
Me-too status Actimec plus injection of Selmore Pharmaceuticals (10ML.
50ML.100ML.)
GMP status Panel inspection conducted on 31-08-2018 & 05-09-2018
recommends resumption of production to M/s decent
Pharmaceuticals by the competent forum of CLB subject to the
following conditions:
 The management has agreed not to manufacture sterile
products prior to the installation of distillation
assembly during this tenure the management has been
advised to conduct BET testing on market samples
(post market surveillance) & retained samples.
 The management shall submit monthly progress report
to the office of concerned Federal inspector of Drugs
on the updated progress on all the undertakings
submitted alongside this report.
 The management has also undertaken to purchase
FTIR within Two months.
(Report by Area FID dated 05-09-2018 verified purchase of
FTIR, So the QA Division vide letter No.F.8-6/2018-QA dated
18th September, 2018 concluded that the firm M/s. Decent
Pharma, Rawat is allowed to resume production in oral
dosage forms. However, production in sterile area shall
remain suspended till the installation of distillation assembly,
verification by the panel of experts and subsequent approval
for resumption of production).
Remarks of the Evaluator Firm has Liquid injection Vet (general section).
Firm is not carrying out Terminal sterilization with this
justification that applied drug product is heat sensitive.
Firm is using Type II glass with this justification that as it is
recommended for acidic, aqueous, & alkaline parenteral
preparation by USP. Furthermore product does not contain any
ingredients which could react with USP type II glass. USP
article 660.
However, The USP article 660 to which the applicant is
referring for the choice of container closure system, states
following:
The following recommendations can be made as to the
suitability of the glass type for containers for pharmaceutical
products, based on the tests for hydrolytic resistance. Type I
glass containers are suitable for most products for parenteral
and nonparenteral uses. Type II glass containers are suitable
for most acidic and neutral aqueous products for parenteral
and nonparenteral uses. Type II glass containers may be used
for alkaline parenteral products where stability data
demonstrate their suitability. Type III glass containers usually
are not used for parenteral products or for powders for
parenteral use, except where suitable stability test data
indicate that Type III glass is satisfactory.
Previous Decision Registration Board in its 286th Meeting deferred the case for
the following reasons:
 Rectification of above stated observation in the
distillation plant made by Panel during the inspection.
 Justification on scientific basis for preferring Type II
glass over Type I glass as a container closure system
for applied formulation or otherwise for use of Type I
glass container for the applied formulation.
 Justification on scientific basis for not performing
terminal sterilization during manufacturing of applied
formulation.
Evaluation By PEC Now the applicant has submitted the following:
 Letter of CLB dated 22nd of January, 2019 confirming
resumption of production in the sterile area.
 No information is available in B.P (Vet) for use of
either type I or type II glass for products containing
Ivermectin& brands containing Ivermectin are
available in market in type II glass, however, we may
opt for type I glass, if recommended by the
Registration Board.
(Evaluation By PEC:As monograph for test/analysis of this
drug product is not present in BP so referring to B.P for this
formulation is not logical, instead, it is present in USP &
initially they were also referring to USP, which states
following: Preserve in single-dose or multidose containers,
preferably of Type I glass or plastic. Store at a temperature not
higher than 30°).
 Ivermectin is heat sensitive with melting point of
150C. Terminal sterilization requires pressure 15
pounds & temperature of 121C which is close to the
melting point of Ivermectin. So, the terminal
sterilization will result in loss of contents of
Ivermectin. Further, Pharmacopoeial monographs both
in B.P/USP do not mention terminal sterilization for
finished product containing Ivermectinhowever, we
may opt for terminal sterilization if recommended by
the Registration Board.
(Evaluation By PEC: Official books/ Official monographsdon’t
actually mention any specific method for sterilization of a drug
product instead, these states that product should comply to the
test for sterility.)
Decision:
1098. Name and address of M/s. Decent Pharma plot # 30Street SS 3 National
Brand Name +Dosage Form + Clozamax oral suspension 110mg/ml
Strength
Closantal…. 110mg
Type of Form Form-5
Finished Product Specification B.P Specifications
Pack size & Demanded Price 100ml, 500ml, 1 Litre; Decontrolled
Authorities.
Me-too status Closenmall of mallard Pharmaceuticals, Multan (Reg #
046690) (not verifiable)
Remarks of the Evaluator. Firm has Liquid Vet (general section).
Evidence of Me Too provided by the firm is not verifiable.
the following:
 For evidence of applied formulation/drug already
Evaluation By PEC Now the firm has submitted Me Too of applied drug product:
Closenmall 11% Liquid (Reg No. 046690) Of Mallard
Pharmaceuticals, Multan.
Decision:
Brand Name +Dosage Form + Biomectin LA injection
Strength
Ivermectin…. 20mg
Diary No. Date of R& I & fee Dy No.1193;02-05-2017 : 20,000/-, 28-04-2017
Type of Form Form-5
Pack size & Demanded Price 50ml (i.m, subcut); Decontrolled
Authorities.
Me-too status Elvomec D/S. Injection 2% Of Elko Organization (Pvt) Ltd.,
Karachi (50ML, 100ML)
Remarks of the Evaluator. Firm has Liquid injection Vet (general section).
article 660.
following:
formulation.
Registration Board.
finished product containing Ivermectinhowever; we
Decision:
Brand Name +Dosage Form + Solofos Injection
Strength
Toldfimos sodium …. 100mg
Pharmacological Group Immune booster
Type of Form Form-5
Authorities.
Me-too status Fosfan Injection Of Selmone Agencies Lahore (20ml, 50ml)
article 660.
following:
formulation.
Registration Board.
drug product is not present in BP (vet), so referring to BP
(vet), for this formulation is not logical;rather the guidelines
given in USP article 660 (stated above) may be used as
reference for the choice of container closure system.
 It is heat sensitive with melting point of 150C.
Terminal sterilization requires pressure 15 pounds &
temperature of 121C which is close to the melting
point of Ivermectin. So, the terminal sterilization will
result in loss of contents of Ivermectin. Further,
Pharmacopoeial monographs both in B.P/USP do not
mention terminal sterilization for finished product
containing Ivermectinhowever; we may opt for
terminal sterilization if recommended by the
Registration Board.
Decision:
Brand Name +Dosage Form + Doramax Injection
Strength
Doramectin…. 10mg
Type of Form Form-5
Authorities.
Me-too status Dectomax Injectable Solution Of Ghazi Brothers, Karachi. (
10ml, 20ml, 25ml, 50ml, 200ml, 500ml)
article 660.
following:
formulation.
Registration Board.
drug product is not present in BP (vet), so referring to BP
(vet), for this formulation is not logical; rather the guidelines
given in USP article 660 (stated above) may be used as
reference for the choice of container closure system.
 Doramectin belongs to group Ivermectinwhich is heat
sensitive with melting point of 150C. Terminal
sterilization requires pressure 15 pounds &
temperature of 121C which is close to the melting
point of Ivermectin. So, the terminal sterilization will
result in loss of contents of Ivermectin. Further,
Pharmacopoeial monographs both in B.P/USP do not
mention terminal sterilization for finished product
containing Ivermectinhowever, we may opt for
terminal sterilization if recommended by the
Registration Board.
Decision:
Brand Name +Dosage Form + Evomec LA Injection
Strength
Ivermectin ....10mg
Type of Form Form-5
Authorities.
Me-too status Actimec injection of Selmore Pharmaceuticals (10ML.20ml
50ML.100ML.)
article 660.
following:
and non-parenteral uses. Type II glass containers are suitable
and non-parenteral uses. Type II glass containers may be used
formulation.
Registration Board.
finished product containing Ivermectinhowever, we
Decision:
Brand Name +Dosage Form + Choice Oral Powder
Strength
Composition Each kg powder contains:-
Doxycycline HCl....400gm
Tylosin tartrate….200gm
Colistin Sulphate…. 500MIU
Bromhexine HCl…. 10gm
Pharmacological Group Anti-bacterial/mucolytic agent
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 01kg, 2.5kg, 5kg, 10kg, 20kg, 25kg;
Decontrolled
Authorities.
Me-too status Respi 100 W/S Powder of Dmaarson Pharmaceuticals Rawat.
(not verifiable)
Remarks of the Evaluator. Evidence of Me Too provide by the firm is not verifiable.
Firm has submitted letter of CLB dated 12th March, 2013
verifying manufacturing facility “Oral dry Powder Section
(vet)”.
 For evidence of applied formulation/drug already
Evaluation By PEC Now the firm has submitted Me Too of applied drug product:
Fit Respi Water Soluble Powder (Reg No.078268) Of D-
Maarson Pharmaceuticals
Decision:
Evaluator PEC-XIV
1104. Name and address of manufacturer / M/s. Decent Pharma Plot No. 30, Street SS 3,
Applicant National Industrial Zone, Rawat
Brand Name +Dosage Form + Strength FENLOR PLUS ORAL SOLUTION
Florfenicol …………………100mg
Diary No. Date of R& I & fee 21-10-2016, Dy. No.2119, Rs.20,000/-, 19-10-2016
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 150ml, 200ml, 450ml,500ml, 1Litre,
2.5Litre, 5Litre, 10Litre, 20Litre; Decontrolled
Me-too status Maxi-Flor Liquid of M/s.Biogen Pharma (Reg#075612)
GMP status QA Division vide letter No.F.8-6/2018-QA dated 18th
September, 2018 concluded that the firm M/s. Decent
remain suspended till the installation of distillation
assembly, verification by the panel of experts and
subsequent approval for resumption of production.
Previous remarks of the Evaluator.
Previous decision Deferred for correction of pharmacological group
(M-286).
Evaluation by PEC The firm has now submitted Pharmacological group as
“Antibacterial/ Amphenicol”.
Decision:
Brand Name +Dosage Form + Strength AQUAFLOR Oral Solution
Florfenicol………..…….230mg
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 150ml, 200ml, 450ml, 500ml, 1Litre,
2.5Litre, 5Litre, 10Litre, 20Litre;Decontrolled
Me-too status Neflox solution of Selmore Pharma (Reg # 049647)
(M-286).
Evaluation by PEC The firm has now submitted Pharmacological group as
“Antibacterial/ Amphenicol”.
Decision:
Brand Name +Dosage Form + Strength AMCO DOX Water Soluble Powder
Composition Each Kg powder contains:
Doxycycline Hyclate…………….. 500g
Type of Form Form-5
Pack size & Demanded Price 50g, 100g, 500g, 1kg, 5Kg, 10Kg,20Kg; Decontrolled
Me-too status Riz wan-S W/S Powder of Nawal Pharma
QA division vide letter No. F.8-9/2018-QA (M-267-
CLB) informed that the firm is directed to resume
production activity in sterile area.
Previous 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 (M-286).
Evaluation by PEC The firm has submitted me-too reference “Doxyveto-
50S Soluble Powder of M/s Orient Traders
(Reg#023470)” which has been verified from database.
Decision:
Brand Name +Dosage Form + Strength CTD Oral Powder
Colistin Sulphate………………500MIU
Tylosin Tartrate………………..100gm
Doxycycline HCl………………200gm
Pharmacological Group Antibacterial & Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 50g, 100g, 500g, 1kg, 5Kg, 10Kg, 20Kg, 25kg;
Decontrolled
Me-too status CT-DOX WSP of M/s Inshal Pharma (Reg#048172)
Previous decision Deferred for correction of Pharmacological group.
(M-286).
Evaluation by PEC The firm has now submitted pharmacological group as
“Antibacterial”.
Decision:
Brand Name +Dosage Form + Strength PRIDE Oral Powder
Colistin Sulphate………………480MIU
Bromhexine HCl……………….5gm
Pharmacological Group Antibacterial and Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1kg, 5Kg, 10Kg, 20Kg, 25kg; Decontrolled
Me-too status PULMOMATS WSP of M/s. Nawal Pharma
(Reg#074093)
(M-286).
“Antibacterial/Mucolytic”.
Decision:
Brand Name +Dosage Form + Strength KLIK Oral Powder
Composition Each Kg contains:
Colistin Sulphate………………60gm
Bromhexine HCl……………….20gm
Pharmacological Group Antibacterial and Bronchodilator
Type of Form Form-5
Pack size & Demanded Price 100g, 500g, 1kg, 5Kg, 10Kg, 20Kg, 25kg; Decontrolled
Me-too status NOBI TDC 680 of M/s. Noble Pharma (Reg#074093)
(M-286).
“Antibacterial/Mucolytic”.
Decision:
Brand Name +Dosage Form + Strength ZESEL ORAL SOLUTION
Composition Each Liter contains:
Vitamin E……………..200,000mg
Sorbitol……………….50,000 mg
Choline Chloride………50,000 mg
Vitamin C……………...20,000 mg
Selenium as sodium selenite……..150 mg
Zinc as Zinc Sulphate……………4000 mg
Pharmacological Group Multivitamin/Nutritional Supplement
Type of Form Form-5
2.5Litre, 5Litre, 10Litre, 20Litre;Decontrolled
Me-too status Vestol-Forte oral liquid of M/s Sanna
(Reg#078272)
Previous decision Deferred for rationale of quantities of APIs in applied
formulation (M-286).
Evaluation by PEC The firm has submitted label of already registered
product Vestol-Forte which describes that it is a proven
combination of Selenium and Vitamin E with added
qualities of Vitamin C, Zinc, choline and sorbitol, which
are inevitable for combating low fertility and
hatchability.
Decision:
Brand Name +Dosage Form + Strength U FLOR ORAL SOLUTION
Florfenicol……………….200mg
Type of Form Form-5
Me-too status FLUROTIN LIQUID of M/s Elegance (Reg#075751)
(M-286).
“Antibacterial/Amphenicol”.
Decision:
Brand Name +Dosage Form + Strength MYCOFLOR ORAL LIQUID
Composition Each liter contains:
Florfenicol…………………110gm
Colistin Sulphate…………..500MIU
Type of Form Form-5
Me-too status F-COL Liquid of M/s D-Maarson (Reg#072679)
(M-286).
“Antibacterial/Amphenicol”.
Decision:
1113. Name and address of manufacturer / M/s Farm Aid Group, Plot # 3/2, Phase I & II,
Applicant Hattar industrial Estate, Haripur
Brand Name +Dosage Form + Strength THIACOL ORAL LIQUID
Thiamphenicol…………………200mg
Pharmacological Group Amphenicols (Broad spectrum Antimicrobial)
Type of Form Form-5
Pack size & Demanded Price 50ml, 100ml, 200ml, 250ml, 500ml, 1L, 2.5 L, 5L, 10L,
15L, 20L, 25L; Decontrolled
Me-too status TRISAN 200 Liquid of M/s prix Pharma
GMP status Routine GMP inspection dated 07-09-2017 showed that
the firm was working under satisfactory level of GMP.
Remarks of the Evaluator. The firm has submitted revised Form-5 with following
label claim:
Each 100ml of solution contains:
Thiamphenicol…………………25g
Firm has submitted fee challan of Rs. 5000/- (deposit
slip#0757431) dated 18-09-2018 and fee challan of
Rs.15,000/- (deposit slip#0816906) dated 03-01-2019.
Decision:
Case No. 05: Registration applications of newly granted DML or New section (Veterinary)
a. New DML/secton
Evaluator PEC-VII
Case of M/s Mylab Pvt Ltd. Khankah Sharif Bahawalpur
CLB in its 266 meeting held on 24 October , 2018 has considered the approval of seven additional sections
grant
Accordingly, firm has applied for following products for consideration by Drug Registration Board.

1 Aerosol (Vet) 10 9
1114. Name and address of manufacturer / M/s Mylab Pvt Ltd. Khankah Sharif
Applicant Bahawalpur
Brand Name +Dosage Form + Strength Tetramide Spray
Dated 15-01-2018
Composition Each 100gm Contains:
Chlotetracycline…367000IU
Sulphanilamide…5.963mg
Pharmacological Group Insecticide/hormonal analogue
Type of Form Form-5
Pack Size & Demanded Price 100, 150, 210 ml, 250 ml
As per SRO (10% less then brand leader
Approval Status of Product in Reference Oro-spray vetoquinol Ireland
Me-too Status Orospray External Spray (027453)
GMP status Last GMP inspection conducted on 13-9-2018 to
14-9-2018 for grant of additional section
Remarks of the Evaluator VII  Aerosol vet section present (can solid
spray manufactured in this facility)
Decision:
Brand Name +Dosage Form + Strength Roximax Topical Spray
Diary No. Date of R& I & fee Dy.No 2008 dated 16-01-2018 Rs. 20,000 Dated
15-01-2018
Composition Each 170 gm Bottle Contains:
Rifaximin…0.5gm
Type of Form Form-5
Pack Size & Demanded Price 10ml, 20 ml, 30 ml, 50 ml and 100 ml
Me-too Status FATROXIMIN TOPIC SPRAY (021263)
GMP status Last GMP inspection conducted on 13-9-2018 to
14-9-2018 for grant of additional section
Decision:
Brand Name +Dosage Form + Strength Hydrocort Spray
Dated 15-01-2018
Oxytetracycline…5mg
Hydrocortisone…1.6mg
Type of Form Form-5
As per SRO (10% less then brand leader)
Me-too Status CORTISEL SPRAY (071079)
GMP status Last GMP inspection conducted on and
Decision:
Brand Name +Dosage Form + Strength Anti-Mastitis Spray
Dated 15-01-2018
Composition Each 15gm Contains:
Rifaximin…0.100gm
Cefacetrile Sodium…0.200gm
Pharmacological Group Anti-Mastitis
Type of Form Form-5
Me-too Status CEFAXIMIN-L ANTI MASTITIS SPRAY
(019906)
Decision:
Brand Name +Dosage Form + Strength Alspray
Dated 15-01-2018
Composition Each gm Contains:
Aluminium Powder…40mg
Pharmacological Group Antiseptic
Type of Form Form-5
Pack Size & Demanded Price 210
As per brand leader
Me-too Status ALUSPRAY PRESSURIZED SUSPENSION
(028560)
Decision:
Brand Name +Dosage Form + Strength Pink spray
Diary No. Date of R& I & fee Dy.No 44227 dated 28-12-2018 Rs. 20,000
(26/12/2018)
Composition Each 150 ml Contains:
Chloramphenicol….. 7.5 gm
Cetrimide…………...1.5 gm
Phthalate ……………1.5 gm
Crystal violet ……….0.75gm
Type of Form Form-5
Pack Size & Demanded Price 250 ml
As per brand leader
Me-too Status PINKSPRAY (020078)
Decision:
Brand Name +Dosage Form + Strength Oxycart spray
(26/12/2018)
Oxytetracyclin….. 750 mg
Oxycartisone……..240 mg
Pharmacological Group Antibiotic/steroidal solution
Type of Form Form-5
As per brand leader
Me-too Status NA
Remarks of the Evaluator VII Me too not available
Decision:
Brand Name +Dosage Form + Strength Tetragen spray
(26/12/2018)
Oxytetracyclin HCl….. 40 mg
Gentian violet……..04 mg
Permethrine……..10 mg
Citronella oil……..20 mg
Pharmacological Group Antibacterial/fly repellent
Type of Form Form-5
As per brand leader
Me-too Status TERAGEN PLUS AEROSOL SPRAY (063623)
Decision:
Brand Name +Dosage Form + Strength Roximax Intrauterine Foam
Dated 15-01-2018
Composition Each 13.4gm Bottle Contains:
Rifaximin…0.10gm
Type of Form Form-5
Pack Size & Demanded Price 100, 500, 1kg, 10 kg, 25 kg
As per SRO (10% less then brand leader)
Approval Status of Product in Reference Itlay
Me-too Status FATROXIMIN INTRAUTERINE FOAM.
('048129)
Decision:
Brand Name +Dosage Form + Strength Liberty Vet Spray
Dated 15-01-2018
Composition Each Liter Contains:
Permethrin…15.44gm
(S)-Methoprene…0.34gm
Pharmacological Group Insecticide/hormonal analogue
Type of Form Form-5
Pack Size & Demanded Price 50, 100, 150, 210 ml
Me-too Status NA
Remarks of the Evaluator VII Proof of me-too product (name and registration
number) with same dosage form, same salt form,
same strength and same volume/pack size (as
demanded) is required.
Decision:
Evaluator PEC-XII
Case. No. M/s Mylab Pvt Ltd. Bahawalpur. (New Section)
The Central Licensing Board in its 266th meeting held on 24th Oct, 2018 has considered and approved the grant
of 7 additional section of firm M/s Mylab Pvt Ltd. Khankah Sharif Bahawalpur Pakistan (DML:000747) as
under:-
1 Liquid injectable (Penicillin) Veterinary 20 10

2 Oral liquid (General) Veterinary 10 10
3 Dry powder injectable (Penicillin) Veterinary - -
4 Liquid Injectable (Hormone) Veterinary - -
5 Liquid Injectable (Steroid) Veterinary - -
6 Aerosol Veterinary - -
7 Oral powder (Penicillin) Veterinary - -
Liquid injectable (Penicillin) Veterinary
20 products / 10 molecules
1124. Name and Address of Manufacturer / M/s Mylab Pvt Ltd.
Applicant Khankah Sharif Bahawalpur
Brand Name + Dosage Form + Strength Propen-300 Injection
Diary No. Date of R & I & fee Form-5 Dy.No 2017 dated 16-01-2018 Rs. 20,000 Dated
15-01-2018
Procaine Penicillin…300mg
Pharmacological Group Broad spectrum antibiotic
Type of Form Form 5
Pack Size & Demanded Price 50ml /Decontrolled
Approval Status of Product in Reference N/A
Me-too Status NAWAPEN-30 by M/s NAWAN LABORATORIES
(Reg#053996)
Renewal of DML and Grant of additional sections.
Panel recommends Renewal of DML and Grant of
additional sections.
Decision:
Brand Name + Dosage Form + Strength LA Durapen Injection
15-01-2018
Procaine Penicillin G…100000IU
Benzathine Penicillin G…150000IU
Dihydrostreptomycin sulphate…200mg
Type of Form Form 5
Me-too Status BPS-LA INJECTION by M/s SELMORE
Decision:
Brand Name + Dosage Form + Strength Bactillin Injection
15-01-2018
Amoxcillin (as trihydrate) …10gm
Colistin sulphate…25,000,000IU
Type of Form Form 5
Me-too Status AMOXILIST LA INJECTION. by M/s BREEZE
PHARMA (PVT.) LTD (Reg#063550)
Decision:
Brand Name + Dosage Form + Strength Dorapen Injection
15-01-2018
Procaine Penicillin...200,000IU
Type of Form Form 5
Me-too Status ORIPEN-S INJECTION. by M/s ORIENT
LABORATORIES (Reg#035016)
Decision:
Brand Name + Dosage Form + Strength Duramox Injection
15-01-2018
Amoxcillin trihydrate…150mg
Gentamycin as sulphate…40mg
Type of Form Form 5
Pack Size & Demanded Price 50ml/Decontrolled
Me-too Status GENTAMOX INJECTION by M/s MARUSH (PVT)
LIMITED (Reg#080160)
Decision:
Brand Name + Dosage Form + Strength Selmox LA Injection
Dated 04-12-2018
Amoxicillin as trihydrate…200mg
Type of Form Form 5
Me-too Status NOVAMOX 20% LA INJECTION. by M/s SELMORE
Decision:
Brand Name + Dosage Form + Strength Streptomet Injection
Dated 04-12-2018
Procaine Penicillin G…200,000 IU
Dihydrostreptomycin Sulphate…200mg
Type of Form Form 5
Me-too Status STREPTOMET INJECTION by M/s SELMORE
Decision:
Brand Name + Dosage Form + Strength Clavet Injection
Dated 04-12-2018
Amoxicillin as Trihydrate…140mg
Clavulanic Acid (as potassium clavulanate) …35mg
Type of Form Form 5
Me-too Status CLAVET INJECTION by M/s SELMORE
PHARMACEUTICALS ( (Reg#046519)
Remarks of the Evaluator.  Brand name resemblance
Decision:
Brand Name + Dosage Form + Strength Mybiotic LA Injection
Dated 04-12-2018
Procaine Penicillin…100,000 IU
Benzyl Penicillin…150,000 IU
Type of Form Form 5
Me-too Status Not confirmed
Remarks of the Evaluator.  Me-too Status not confirmed from available database.
Decision:
Brand Name + Dosage Form + Strength Maxivet-LA Injection
Dated 27-12-2018
Amoxicillin trihydrate…150mg
Type of Form Form 5
Me-too Status Amoxy LA Injection by M/s Inshal Pharmaceutical
Industries (Reg#073932)
Decision:
Brand Name + Dosage Form + Strength Bactillin Injection
Dated 26-12-2018
Amoxcillin (as trihydrate) …10gm
Colistin sulphate…25,000,000IU
Type of Form Form 5
Me-too Status AMOXILIST LA INJECTION. by M/s BREEZE
PHARMA (PVT.) LTD (Reg#063550)
Decision:
Brand Name + Dosage Form + Strength Propen-300 Injection
Dated 26-12-2018
Procaine Penicillin…300mg
Type of Form Form 5
Me-too Status NAWAPEN-30 by M/s NAWAN LABORATORIES
(Reg#053996)
Decision:
Brand Name + Dosage Form + Strength Streptomet Injection
Dated 26-12-2018
Type of Form Form 5
Me-too Status STREPTOMET INJECTION by M/s SELMORE
Decision:
Brand Name + Dosage Form + Strength Dorapen Injection
Dated 26-12-2018
Type of Form Form 5
Me-too Status ORIPEN-S INJECTION. by M/s ORIENT
LABORATORIES (Reg#035016)
Decision:
Brand Name + Dosage Form + Strength Duramox Injection
Dated 26-12-2018
Amoxicillin trihydrate…150mg
Gentamicin as sulphate…40mg
Type of Form Form 5
Me-too Status GENTAMOX INJECTION by M/s MARUSH (PVT)
LIMITED (Reg#080160)
Decision:
Brand Name + Dosage Form + Strength Clavet Injection
Dated 26-12-2018
Clavulanic Acid (as potassium clavulanate) …35mg
Type of Form Form 5
Me-too Status CLAVET INJECTION by M/s SELMORE
PHARMACEUTICALS ( (Reg#046519)
Remarks of the Evaluator.  Brand name resemblance
Decision:
Brand Name + Dosage Form + Strength LA Durapen Injection
Dated 26-12-2018
Benzathine Penicillin G…150,000 IU
Type of Form Form 5
Me-too Status BPS-LA INJECTION by M/s SELMORE
Decision:
Brand Name + Dosage Form + Strength Mybiotic LA Injection
Dated 27-12-2018
Benzyl Penicillin…100,000 IU
Type of Form Form 5
Me-too Status Not confirmed
Remarks of the Evaluator.  Me-too Status not confirmed from available database.
Decision:
Brand Name + Dosage Form + Strength Maxivet-LA Injection
Dated 27-12-2018
Type of Form Form 5
Me-too Status Amoxy LA Injection by M/s Inshal Pharmaceutical
Industries (Reg#073932)
Decision:
Brand Name + Dosage Form + Strength Selmox-LA Injection
Dated 27-12-2018
Amoxicillin as trihydrate…200mg
Type of Form Form 5
Me-too Status NOVAMOX 20% LA INJECTION. by M/s SELMORE
Decision:
Oral liquid (General) Veterinary
10products / 10 molecules
Brand Name + Dosage Form + Strength Vitaking-E Liquid
Dated 27-02-2018
Alpha-Tocopherol Acetate (Vitamin E)…150mg
Pharmacological Group Vitamin
Type of Form Form 5
Pack Size & Demanded Price 100ml, 500ml, 1L, 5L, 10L, 20L, 25L /Decontrolled
Me-too Status HOKOSAN E LIQUID by M/s U.M.ENTER PRISES
(Reg#021446)
Decision:
Brand Name + Dosage Form + Strength Timpavax Liquid
Dated 27-02-2018
Di (Ethyl-Hexyl) Sulphosuccinate…200mg
Polydimethyl Siloxane…3.5mg
Pharmacological Group Stool softner, laxative and lubricant
Type of Form Form 5
Pack Size & Demanded Price 100ml, 500ml, 1L, 5L, 10L, 20L, 25L /Decontrolled
Me-too Status TIMPAVEEX by M/s AIMS TRADER (Reg#008315)
Remarks of the Evaluator. Brand name resemblance.
Decision:
Brand Name + Dosage Form + Strength Doxisol Oral Solution
Dated 27-02-2018
Doxycycline Hycalate…200mg
Type of Form Form 5
Pack Size & Demanded Price 100ml, 500ml, 1L, 5L, 10L, 20L /Decontrolled
Me-too Status DOXY 20% ORAL LIQUID by M/s ATTABAK
PHARMACEUTICAL (Reg#058911)
Remarks of the Evaluator. Firm has applied as Doxycycline Hycalate…200mg/ml,
whereas, formulation approved by DRAP is Doxycycline
hydrochloride…200mg/ml.
Decision:
Brand Name + Dosage Form + Strength Sulbectra Oral Suspension
Dated 27-02-2018
Trimethoprim…80mg (8%w/v)
Sulphadiazine…400mg (40%w/v)
Pharmacological Group Combinations of sulfonamides and trimethoprim, incl.
derivatives
Type of Form Form 5
Pack Size & Demanded Price 500ml, 1L, 5L, 10L, 20L, 25L /Decontrolled
Me-too Status TRYTON SOLUTION by M/s GUYTON
PHARMACEUTICAL (Reg#032225)
Decision:
Brand Name + Dosage Form + Strength Curbex Liquid
Dated 27-02-2018
Composition Each litre Contains:
Ammonium Propionate…65%
Mono and Diglycerides…1.25%
Phosphoric Acid…0.50%
Sorbic Acid…0.25%
Pharmacological Group Acidifiers
Type of Form Form 5
Pack Size & Demanded Price 1L, 5L, 10L, 20L, 25L /Decontrolled
Me-too Status MYCO CURB LIQUID by M/s VET PHARMA
TRADING (Reg#)020146
Decision:
Brand Name + Dosage Form + Strength Levadox Drench
Dated 04-12-2018
Levamisole hydrochloride…1.5gm
Cobalt Sulphate…0.382gm
Sodium Selenite…0.050gm
Type of Form Form 5
Pack Size & Demanded Price 250ml, 500ml, 1L, 5L /Decontrolled
Me-too Status VERNIL S.C. DRENCH by M/s STAR
LABORATORIES (PVT) LTD (Reg#033261)
Decision:
Brand Name + Dosage Form + Strength Combiox Drench
Dated 04-12-2018
Oxyclozanide…94mg
Oxfendazole…34mg
Cobalt Sulphate…3.82mg
Sodium Selenite…0.50mg
Type of Form Form 5
Pack Size & Demanded Price /Decontrolled
Me-too Status COMBIOX DRENCH by M/s SELMORE
PHARMACEUTICALS (PVT) LTD (Reg#057004)
Remarks of the Evaluator.  Brand name resemblance.
Decision:
Brand Name + Dosage Form + Strength I-Tolodox-C Oral Solution
Dated 04-12-2018
Tylosin tartrate…14gm
Doxycycline hydrochloride…16gm
Colistin sulphate…120 MIU
Type of Form Form 5
Me-too Status I-TYLODOX-C ORAL SOLUTION by M/s
INTERNATIONAL PHARMA LABS (Reg#079847)
Decision:
Brand Name + Dosage Form + Strength Interfenicol 25% Oral Solution
Dated 04-12-2018
Florfenicol…25gm
Type of Form Form 5
Me-too Status FLORFENICOL ORAL LIQUID by M/s ATTABAK
Decision:
Brand Name + Dosage Form + Strength Scournil Oral Suspension
Dated 04-12-2018
Sulphadiazine…3.550gm
Sulphadimidine…2.840gm
Kaolin…10.33gm
Pectin…0.710gm
Hyoseine Butyl Bromide…0.004gm
Neomycin Sulphate…0.180gm
Vitamin B1…0.015gm
Vitamin B2…0.022gm
Pharmacological Group Combinations of antibiotics, anti-toxins, antispasmodic
and minerals
Type of Form Form 5
Me-too Status SCOUR-X ORAL SUSPENSION by M/s SELMORE
PHARMACEUTICALS (PVT) LTD. (Reg#023661)
Decision:
Case No. 06: Registration applications of categories to be considered on priority

a. Export Facilitation
Evaluator PEC-IV
Export Facilitation: Applications were received through letter No.F.11-1/2014-DD(R-IV)(Pt), The firm
claimed 4 molecules to be considered on priority”.
1154. Name and address of M/S Genome Pharmaceuticals (Pvt) Ltd, Plot # 16/I-
manufacturer / Applicant Phase IV, Industrial Estate Hattar, KPK, Pakistan
Brand Name +Dosage Form + Hesdimine 450mg/50mg Tablet
Strength
Diosmin…….…450mg
Hesperidine……….50mg
08-2018
Pharmacological Group Bioflavonoids
Type of Form Form 5
Approval status of product in Daflon 500mg Tablets of ( ANSM approved)
Me-too status (with strength and Diflon 500mg Tablets Et M/S Hoover Pharma
dosage form)
report concludes that overall the firm was operating under
good level of GMP.
Decision:
Brand Name +Dosage Form + Hesdimine 450mg/50mg Tablet
Strength
Diosmin…….…900mg
Hesperidine……….100mg
08-2018
Pharmacological Group Bioflavonoids
Type of Form Form 5
Approval status of product in Daflon Tablets of ( ANSM approved)
Me-too status (with strength and Daflon Tablets 1000mg M/s Serveir Research and

good level of GMP.
Decision:
Brand Name +Dosage Form + Clopid-S 75mg/75mg Tablet
Strength
Aspirin…….…75mg
Clopidogrel (as bisulphate)……….75mg
08-2018
Pharmacological Group Antiplatelet drug
Type of Form Form 5
Approval status of product in GA CoPlavix Tablet Of (TGA Approved)
Me-too status (with strength and Clodril Plus Tablet M/s Macter International
dosage form)
good level of GMP.
Decision:
Brand Name +Dosage Form + Agolet 25mg Tablet
Strength
Agomelatine…….…25mg
09-2018
Type of Form Form 5
Approval status of product in GA Agomelatine of (MHRA Approved)
Me-too status (with strength and Valdoxan tablet by Servier
dosage form)
good level of GMP.
Decision:
Brand Name +Dosage Form + Rebam 100mg Tablet
Strength
Rebamipide…….100mg
09-2018
Pharmacological Group Antacid, Antireflux Agent & Antiulcerant
Type of Form Form 5
Approval status of product in GA Mucosta 100mg of (MHRA Approved)
Me-too status (with strength and MUCOSTA TABLET 100MG tablet of M/S. OTSUKA
dosage form)
good level of GMP.
Decision:
Evaluator PEC-III
Following applications were received from section R-V Products can be granted priority registration under Export
Facilitation
1159. Name and address of M/s Schazoo Zaka (Pvt) Ltd 20Km Lahore Jaranwala Road
manufacturer / Applicant Sheikhupura
Brand Name +Dosage Form + Vilag Tablet 50mg
Strength
Vildagliptin……50mg
Rs. 20,000/-: 07-01-2019
Pharmacological Group Anti diabetic
Type of Form Form 5
Pack size 4x7’s: Rs. 25/Tablet
Approval status of product in GALVUS vildagliptin 50 mg tablets un-coated by Novartis
Reference Regulatory Authorities. Pharmaceuticals Australia Pty Ltd. TGA approved
Me-too status Glavil 50mg Tablet by Atco Laboratories.
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).
3
Decision:
Brand Name +Dosage Form + Vilag-M Tablet
Strength
Metformin hydrochloride……500mg
Rs. 20,000/-: 07-01-2019
Type of Form Form 5
Pack size 2x7’s: Rs. 26.07/Tablet
Approval status of product in GALVUMET 50/500 film coated tablet by Novartis
Reference Regulatory Authorities. Pharmaceuticals (TGA Australia Approved)
Me-too status Galvus Met 50/500mg Tablets by Novartis.
2- Capsule (Gen)
Decision:
Strength
Rs. 20,000/-: 07-01-2019
Type of Form Form 5
2- Capsule (Gen)
Decision:
Strength
Rs. 20,000/-: 07-01-2019
Type of Form Form 5
2- Capsule (Gen)
Decision:
Evaluator PEC-II
Registration section-V vide its letter No. F.8-6/2013-Reg-V dated 21-12-2018, has stated to consider
following two applications on priority as per decision of 263rd meeting of Registration Board.
The said letter mentions following details:
“The firm claimed one molecule to be considered on priority against USD 974044 (fiscal year Jan-Dec,
2017) duly verified from submitted documents (Form E GD form and shipment/invoices) as per decision of
Registration Board. Two molecules already considered against above mentioned claim.”
1163. Name and address of manufacturer M/s Schazoo Pharmaceutical Laboratories Pvt Ltd.,
/ Applicant 20 Jaranwala Road, Kalwala Stop, Tehsil
Ferozewala, District Sheikhupura.
Brand Name +Dosage Form + Velam Tablets5/80mg
Strength
Amlodipine as besylate …… 5mg
Valsartan ….. 80mg
Diary No. Date of R& I & fee Dy. No 55 dated 01-01-2019 Rs.20,000/- Dated 01-
01-2019
Pharmacological Group Calcium channel blocker/Angiotensin-II receptor
antagonists
Type of Form Form-5
Pack size & Demanded Price 2 x 7’s: Rs. 22.86/tablet
Rs. 320/pack
Me-too status Exforge Tablet of M/s Novartis Pharma (Reg.#047569)
compliance.
Decision:
1164. Name and address of manufacturer M/s Schazoo Pharmaceutical Laboratories Pvt Ltd.,
/ Applicant 20 Jaranwala Road, Kalwala Stop, Tehsil
Ferozewala, District Sheikhupura.
Brand Name +Dosage Form + Velam Tablets5/160mg
Strength
Amlodipine as besylate …… 5mg
Valsartan ….. 160mg
Diary No. Date of R& I & fee Dy. No 56 dated 01-01-2019 Rs.20,000/- Dated 01-
01-2019
Pharmacological Group Calcium channel blocker/Angiotensin-II receptor
antagonists
Type of Form Form-5
Pack size & Demanded Price 2 x 7’s: Rs. 22.86/tablet
Rs. 320/pack
Me-too status Exforge Tablet of M/s Novartis Pharma (Reg.#047570)
compliance.
Decision:
Evaluator-PEC-XII
Following three cases were received from section R-V vide letter No. F.8-6/2013-Reg-V dated 28th December,
2018. According to the contents of the letter the firm has claimed two molecules to be considered on priority
against export worth USD 974044 which is duly verified from submitted documents (Form E GD and shipment
invoices) as per the decision of Registration Board.
1165. Name and Address of Manufacturer / M/s Schazoo Pharmaceutical Laboratories (Pvt)
Applicant Limited,
20km Lahore-jaranwala road, District Sheikhupura.
Brand Name + Dosage Form + Strength Letrose Tablet 2.5mg
Diary No. Date of R & I & fee Dy.No 43934 dated 26-12-2018 Rs.20,000/- Dated 26-
12-2018
Letrozole …2.5mg
Pharmacological Group Aromatase inhibitors
Type of Form Form 5
Pack Size & Demanded Price 1x10’s/Rs.2470
Approval Status of Product in Reference LETROZOLE APOTEX letrozole 2.5 mg film-coated
Regulatory Authorities. tablet by M/s Cipla Australia Pty Ltd (TGA Approved)
Me-too Status Aromek film coated tablet 2.5mg by M/s Glaxy Pharma
(Reg#052258)
GMP Status Last GMP inspection was conducted on 12-06-2017 and
the report concludes good level of GMP compliance.
Decision:
Applicant Limited,
Brand Name + Dosage Form + Strength Decalc Plus Tablet (Orange flavor)
12-2018
Composition Each chewable tablet Contains:
Calcium carbonate …1250mg eq. to elemental calcium
…500mg
Vitamin D …125I.U
Pharmacological Group Calcium supplement with vitamin
Type of Form Form 5
Pack Size & Demanded Price 3x10’s/Rs.86.79
Me-too Status Qalsan D Chewable Tablet by M/s Novartis Pharma
(Reg#055081)
Remarks of the Evaluator.  Approval status of applied formulation in Reference
Regulatory Authorities could not be confirmed.
Decision:
Applicant Limited,
Brand Name + Dosage Form + Strength Decalc Plus Tablet (Mix fruit flavor)
12-2018
Composition Each chewable tablet Contains:
Calcium carbonate …1250mg eq. to elemental calcium
…500mg
Vitamin D …125I.U
Pharmacological Group Calcium supplement with vitamin
Type of Form Form 5
Pack Size & Demanded Price 3x10’s/Rs.86.79
Me-too Status Qalsan D Chewable Tablet by M/s Novartis Pharma
(Reg#055081)
Remarks of the Evaluator.  Approval status of applied formulation in Reference
Regulatory Authorities could not be confirmed.
Decision:
Following one case was received from section R-III vide letter No. F.6-2/2016-Reg-III dated 17th December,
2018. According to the contents of the letter the firm has claimed one molecule to be considered on priority as
per the decision of Registration Board.
1168. Name and Address of Manufacturer / M/s Ambrosia Pharmaceuticals
Applicant Plot#18, Street#9, National Industrail Zone, Rawat-
Islamabad..
Brand Name + Dosage Form + Strength Infacol Plus Gel Suspension
08-2018
Dicyclomine hydrochloride …2..5mg,
Aluminium hydroxide …200mg
Light magnesium oxide …100mg
Simethicone …20mg
Pharmacological Group Antacid, antiflatulannt, antispasmodic, demulcent
Type of Form Form 5
Pack Size & Demanded Price 60ml/Rs.93.33
Approval Status of Product in Reference Kolanticon Gel Suspension by M/sPeckforton
Regulatory Authorities. Pharmaceuticals (MHRA Approved)
Me-too Status Peptogel Suspension by M/s Mediways (Reg#030280)
During the follow up inspection of M/s Ambrosia
Pharmaceuticals Rawat, it is observed, that majority of
the observations noted in the previous inspection i.e.
conducted on 16-07-2018 have been rectified and the firm
was found working in compliance to GMP as of the date
of inspection.
Decision:
b. Local manufacturing applications of priority categories defined by Registration

Board in its 257th meeting
Evaluator PEC-V
1169. Name and address of Manufacturer / "M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 129, Sundar Industrial Estate, Raiwind Road,
Lahore"
2018
Brand Name+Dosage Form+Strength Lefimide 10mg Tablet
Leflunomide…10mg"
Pharmacological Group Selective immunosuppressant
Type of Form Form 5
Pack Size & Demanded Price 30’s. As per SRO.
Zefora Tablets 10mg
M/s Global Pharmaceuticals, Plot No 204-205, Kahuta
Triangle, Industrial Area, Islamabad.
“The panel of inspectors was of the opinion, that the firm
M/s Wimits Pharmaceuticals Lahore had maintained
satisfactory conformance to GMP Compliance in the
manufacturing and Quality control operations on the day
of inspection.”
GMP Certificate issued on 10-12-2018.
Decision:
1170. Name and address of Manufacturer / "M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 129, Sundar Industrial Estate, Raiwind Road,
Lahore"
2018
Brand Name+Dosage Form+Strength Lefimide 20mg Tablet
Leflunomide…20mg"
Pharmacological Group Selective immunosuppressant
Type of Form Form 5
Pack Size & Demanded Price 30’s. As per SRO.
Zefora Tablets 20mg
M/s Global Pharmaceuticals, Plot No 204-205, Kahuta
Triangle, Industrial Area, Islamabad.
“The panel of inspectors was of the opinion, that the firm
M/s Wimits Pharmaceuticals Lahore had maintained
satisfactory conformance to GMP Compliance in the
manufacturing and Quality control operations on the day
of inspection.”
GMP Certificate issued on 10-12-2018.
Decision:
1171. Name and address of Manufacturer / "M/s Briell Pharmaceutical (Pvt) Ltd.
Applicant 538C Sundar Industrial Estate Multan Road, Lahore."
2018
Brand Name+Dosage Form+Strength Famera 2.5mg Tablet
Letrozole…2.5mg"
Pharmacological Group Hormone antagonists and related agents,
Aromatase inhibitors
Type of Form Form 5
Approval status of product in Femara
Reference Regulatory Authorities USFDA Approved.
Letzole 2.5mg Tablet
M/s Opal Labs, Karachi .
GMP status Last inspection report dated 25-04-2017, the panel
recommended the grant of New DML.
Remarks of Evaluator Form 5 not signed by applicant and undertaking also not
signed.
Decision:
1172. Name and address of Manufacturer / "M/s Espoir Pharmaceuticals.

Applicant PCSIR KLC TBIC-II PCSIR Laboratory Complex,
Shahrah-e-Dr. Salim Uz Zaman Siddiqui Off University
Road, Karachi"
2018
Brand Name+Dosage Form+Strength Letram 2.5mg Tablet
Letrozole…2.5mg"
Pharmacological Group Hormone antagonists and related agents,
Aromatase inhibitors
Type of Form Form 5
Pack Size & Demanded Price 10’s,20’s,30’s, As per SRO
Approval status of product in Femara
Reference Regulatory Authorities USFDA Approved.
Letzole 2.5mg Tablet
M/s Opal Labs, Karachi .
concludes that firm is found at good level of GMP
compliance.
Decision:
1173. Name and address of Manufacturer / "M/s Kaizen Pharmaceuticals Pvt Ltd.
Applicant E-127-129, North Western Industrial Zone, Bin Qasim,
Karachi"
2018
Brand Name+Dosage Form+Strength Deferox 125mg Tablet
Composition "Each Dispersible Tablet Contains:
Deferasirox…125mg"
Type of Form Form 5
Pack Size & Demanded Price 10’s, 20’s, 30’s, As per SRO.
"Osveral 125mg Dispersible
M/s Osvah Pharmaceutical Company, Iran.Nextar Pharma,
Karachi
“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.”
Decision:
Evaluator PEC-XIII
1174. Name and address of manufacturer / M/s Wimits Pharmaceuticals (Pvt.) Limited, Plot # 129,
Applicant Sundar Industrial Estate (P.I.E.) Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Roxwin tablet 250mg
Deferasirox …………....250mg
Pharmacological Group Iron chelating agent
Pack size & Demanded Price 10’s, 30’s & as per SRO
Approval status of product in Reference Exjade 250mg dispersible tablet of M/s Novartis Pharma
Me-too status Oderox-250mg dispersible tablet of M/s A.J. Mirza
the report concludes satisfactory GMP compliance.
Remarks of the Evaluator  Firm has General tablet section as mentioned in
 No official monograph is available in USP, BP,
IP or JP for the applied formulation.
Decision:
1175. Name and address of manufacturer / M/s Wimits Pharmaceuticals (Pvt.) Limited, Plot # 129,
Applicant Sundar Industrial Estate (P.I.E.) Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Roxwin tablet 500mg
Deferasirox ……...…….500mg
Pharmacological Group Iron chelating agent
Pack size & Demanded Price 10’s, 30’s & as per SRO
Approval status of product in Reference Exjade 500mg dispersible tablet of M/s Novartis Pharma
Me-too status Oderox -500 dispersible tablet of M/s A.J. Mirza Pharma
(Pvt.) Ltd (Reg.# 078116)
the report concludes satisfactory GMP compliance.
Remarks of the Evaluator  Firm has General tablet section as mentioned in
 No official monograph is available in USP, BP,
IP or JP for the applied formulation.
Decision:
Evaluator PEC-XIV
1176. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd, 30th Kilometer,
Applicant Multan Road, 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 Reference Nolvadex Tablet of Astrazeneca (USFDA approved)
Me-too status Tamoxifen Sandoz 10mg Tablet by Novartis Pharma
(Reg no.047670)
Decision:
1177. Name and address of manufacturer / M/s Pacific Pharmaceuticals Ltd, 30th Kilometer,
Applicant Multan Road, P.O. Box 399, Lahore, Pakistan
Brand Name +Dosage Form + Strength TAMOXIDEX 20mg TABLET
Tamoxifen citrate equivalent to Tamoxifen………20mg
Pharmacological Group Nonsteroidal Anti-oestrogen
Type of Form Form 5
Pack size & Demanded Price Pack of 30’s; As per SRO
Approval status of product in Reference Nolvadex Tablet of Astrazeneca (USFDA approved)
Me-too status Tamoxifen Sandoz 20mg Tablet by Novartis Pharma
(Reg no.047671)
Decision:
c. Applications submitted on CTD format

Evaluator PEC-III
Firm has been communicated the shortcomings for following two cases along with reminder on
following dates:
Letter: 16th July, 2018
Reminder: 3rd September, 2018
Regardless of reminder firm has not yet replied to any letter and the case is still pending in PEC.
The case is presented before the Board for its consideration.
1178. Name, address of Applicant / Marketing M/s Bosch Pharmaceuticals (Pvt) Ltd., Bosch
Authorization Holder House 221, Sector 23, Korangi Industrial Area,
Karachi.
Name, address of Manufacturing site. M/s Bosch Pharmaceuticals (Pvt) Ltd., Bosch House
221, Sector 23, Korangi Industrial Area, Karachi.
Status of the applicant  Manufacturer
 Importer
 Is involved in none of the above (contract giver)
Dy No. and date of submission Dy No. 21270: 13-06-2018
Details of fee submitted PKR 20,000/-: 13-06-2018
Valid drug manufacturing license DML issued on 16-02-2015 is submitted by the firm.
Evidence of approval of manufacturing facility Copy of approval letter dated 17-3-2015 of Oral dry
/ approved section from licensing authority powder suspension (General) section is submitted.
List of registered drugs in this section Firm has submitted list of 11 products registered in
this section.
Manufacturer’s site master file and credentials N.A
(for importers)
Type of Application  New Drug Product (NDP)
 Generic Drug Product (GDP)
Intended purpose of pharmaceutical product  Domestic sale
 Export sale
 Domestic and Export sales
For imported products, please specify one of NA
following:
Contract Manufacturing as per Rule 20-A of NA
Drugs (Licensing, Registering and Advertising)
Rules, 1976
The proposed proprietary name / brand name Prelox 100mg/5ml Granules for oral suspension
Strength / concentration of drug of Active Each 5ml contains:
Pharmaceutical ingredient (API) per unit Cefpodoxime (as proxetil)…….100mg
Proposed Pack size 50ml (HDPE bottle)
Proposed unit price As per SRO
Pharmacotherapeutic Group of (API) Cephalosporin
Pharmacopoeial reference USP
Route of administration Oral
Dosage form of applied drug Granules for oral suspension
For generic drugs (me-too status) Qink Dry Suspension by Wilshire Laboratories (Reg
# 053636)
The status in reference regulatory authorities Cefpodoxime proxetil for suspension by Sandoz
(USFDA Approved)
Proposed label (outer (secondary) & inner (primary)) & colour scheme in accordance Yes
with Drug (Labelling & Packing) Rules, 1986 along with specimens
Description of Batch numbering system Yes
Training evidence of technical staff with respect of manufacturing of applied drug Not
(mandatory in case of specially designed pharmaceutical product / Novel Dosage provided
Form).
Summary of Product Characteristics (SmPC) including Prescribing Information (PI) Yes but
along with Patient information Leaflet (PIL) of the Finished Pharmaceuticals Product clinical
(FPP). indications
are
different
Commitments Yes
Protocols along with the commitment to follow Good Laboratory Practices (GLP) by Yes
the Manufacturer.
Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance Not
department/section of the Manufacturer / Company. provided
Information on Prior-related Applications Not
provided
Electronic Review Package Not
provided
QIS (Quality Information Summary) Yes
Drug Substance related Document including following:
a. Name and address of API manufacturer. Nectar Lifesciences Limited Vill
Saidpura, The. Dera Bassi, Distt.
Mohali, Punjab. India
b. Approval of manufacturing facility of API by regulatory Not provided.
body of country and validity.
c. Vendor qualification / audit is Document based
Site inspection based
d. Reason for above point (c) GMP status and DMF
MODULE 2: OVERVIEWS & SUMMARIES
Drug Substance Firm has submitted details of drug substance from
DMF from the manufacturer of API
Drug Product Firm has submitted details of drug product
MODULE 3: QULITY / CMC
3.2.S: Drug substance
Manufacturer of API Nectar Lifesciences Limited Vill Saidpura, The.
Dera Bassi, Distt. Mohali, Punjab. India
API Lot No.
Approval of API by regulatory authority of
country of origin or GMP certificate of API
manufacturer issued by regulatory authority of
country of origin.
Documents confirming import of API
3.2.S.1 General Information Attached DMF provides details of nomenclature,
structure and general properties.
3.2.S.2 Manufacture Firm has submitted description of manufacturing
process and process controls and control of materials
3.2.S.3 Characterization Firm has provided details regarding elucidation of
structure and other characteristics and impurities.
3.2.S.4 Control of drug substance Firm has submitted details of specification,
analytical procedures, validation, batch analysis and
justification of specification.
3.2.S.5 Reference standards or materials The DMF provided by firm has not submitted any
details regarding reference standard or materials.
3.2.S.6 Container closure system Firm has provided DMF which specify that material
is packed in LDPE bag.
3.2.S.7 Stability The real time stability data of API has been
conducted at 25oC ±2oC and 60% ± 5% RH, which is
not as per the requirement of zone IV-A.
Accelerated stability data of API is submitted.
3.2.P: Drug Product
3.2.P.1 Description and composition of drug Firm has submitted description and composition of
product drug product.
3.2.P.2 Pharmaceutical development Firm has submitted details of components of drug
products, formulation, overages, and properties,
manufacturing process development, container
closure system, microbiological attributes and
compatibility.
3.2.P.3 Manufacture Firm has submitted detail of manufacturer, batch
formula, description of manufacturing process and
process controls, controls of critical steps and
intermediates.
Firm has not submitted process validation and or
evaluation.
3.2.P.4 Control of excipients Firm has provided details of specifications
(excipients and finished product), analytical
procedures, batch analysis and justification of
specifications.
Firm has not submitted data for validation of
analytical procedure and impurities characterization.
3.2.P.5 Control of drug product Firm has submitted details of specification,
analytical procedures, validation of analytical
procedures, batch analysis, and characterization of
impurities and justification of specification.
3.2.P.6 Reference standard or materials Firm has provided COA of working standard
3.2.P.7 Container closure system Amber glass round bottle 90ml.
3.2.P.8 Stability Firm has submitted stability commitment only.
Firm has not submitted stability study data
Comparative dissolution profile
MODULE 4: NON-CLINICAL / SAFETY
4.2.1 Pharmacology Not provided
4.2.2 Pharmacokinetics Not provided
4.2.3 Toxicology Not provided
MODULE 5: CLINICAL / EFFICACY
NA.
REMARKS OF EVALUATOR
 Training evidence of technical staff with respect of manufacturing of applied drug (1.5.13) is not
provided.
 The details regarding therapeutic indications provided in SmPC (1.5.14) are different from those
approved by USFDA for the same product. Moreover the nature and contents of container is
mentioned as 90ml in SmPC while 50ml in proposed pack size (1.5.4).
 Commitments of sub section 1.5.15, 1.5.16, 1.5.17, 1.5.18 and 1.5.21 are not provided.
 Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance
department/section of the Manufacturer / Company (1.5.22) is not provided.
 Electronic review package (1.6.3) is not provided.
 Approval of manufacturing facility of API by regulatory body of country and validity and Vendor
qualification / audit as per 1.6.5 is not provided.
 The real time stability data of API submitted in DMF has been conducted at 25 oC ±2oC and 60% ±
5% RH, which is not as per the requirement of zone IV-A.
 Validation of analytical procedures (3.2.P.5.3) is not submitted.
 Stability study data (3.2.P.8.3) is not provided. Real-time and accelerated stability study data of 3
batches along with associated documents (documents confirming import of API, signed and
stamped chromatograms and raw data sheets) as per the requirement of 278th meeting of
Registration Board is required.
 Information required in module 4 for pharmacology (4.2.1), Pharmacokinetics (4.2.2) and
Toxicology (4.2.3) including single dose toxicity (4.2.3.1) and repeat dose toxicity (4.2.3.2) is not
provided.
 Page numbers are not mentioned on each page of the submitted dossier, similarly in Form 5-F “See
attachment” is mentioned instead of specifying the exact page number. Since Form 5-F is a legal
form therefore all details provided in this form or its annexures should be easily traceable in the
dossier.
1179. Name, address of Applicant / Marketing M/s Bosch Pharmaceuticals (Pvt) Ltd., Bosch
Authorization Holder House 221, Sector 23, Korangi Industrial Area,
Karachi.
Name, address of Manufacturing site. M/s Bosch Pharmaceuticals (Pvt) Ltd., Bosch House
221, Sector 23, Korangi Industrial Area, Karachi.
Status of the applicant  Manufacturer
 Importer
Dy No. and date of submission Dy No. 21271: 13-06-2018
Valid drug manufacturing license DML issued on 16-02-2015 is submitted by the firm.
Evidence of approval of manufacturing facility Copy of approval letter dated 17-3-2015 of Tablet
/ approved section from licensing authority (General) section is submitted.
List of registered drugs in this section Firm has submitted list of 07 products registered in
this section.
Manufacturer’s site master file and credentials N.A
(for importers)
 Generic Drug Product (GDP)
Intended purpose of pharmaceutical product  Domestic sale
 Export sale
 Domestic and Export sales
For imported products, please specify one of NA
following:
Rules, 1976
The proposed proprietary name / brand name Prelox DS 200mg Tablet
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Cefpodoxime (as proxetil)…….200mg
Proposed Pack size 10’s (Alu/Alu blister Pack)
Proposed unit price As per SRO
Pharmacotherapeutic Group of (API) Cephalosporin
Pharmacopoeial reference USP
Dosage form of applied drug Tablet
For generic drugs (me-too status) Oribro Tablets 200mg by Tabros, Pharma (Reg #
044350)
The status in reference regulatory authorities Cefpodoxime proxetil Tablet 200mg by Sandoz
(USFDA Approved)
Training evidence of technical staff with respect of manufacturing of applied drug Not
(mandatory in case of specially designed pharmaceutical product / Novel Dosage provided
Form).
Summary of Product Characteristics (SmPC) including Prescribing Information (PI) Yes
along with Patient information Leaflet (PIL) of the Finished Pharmaceuticals Product
(FPP).
Commitments Yes
Protocols along with the commitment to follow Good Laboratory Practices (GLP) by Not
the Manufacturer.
Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance Not
department/section of the Manufacturer / Company. provided
Information on Prior-related Applications Not
provided
Electronic Review Package Yes
a. Name and address of API manufacturer. Nectar Lifesciences Limited Vill
Saidpura, The. Dera Bassi, Distt.
Mohali, Punjab. India
b. Approval of manufacturing facility of API by regulatory Not provided.
body of country and validity.
Drug Substance Firm has submitted details of drug substance from
DMF from the manufacturer of API
Drug Product Firm has submitted details of drug product
Manufacturer of API Nectar Lifesciences Limited Vill Saidpura, The.
Dera Bassi, Distt. Mohali, Punjab. India
API Lot No.
Approval of API by regulatory authority of
country of origin.
Documents confirming import of API
3.2.S.1 General Information Attached DMF provides details of nomenclature,
3.2.S.2 Manufacture Firm has submitted description of manufacturing
process and process controls and control of materials
3.2.S.3 Characterization Firm has provided details regarding elucidation of
3.2.S.4 Control of drug substance Firm has submitted details of specification,
analytical procedures, validation, batch analysis and
justification of specification.
3.2.S.5 Reference standards or materials The DMF provided by firm has not submitted any
details regarding reference standard or materials.
3.2.S.6 Container closure system Firm has provided DMF which specify that material
is packed in LDPE bag.
3.2.S.7 Stability The real time stability data of API has been
conducted at 25oC ±2oC and 60% ± 5% RH, which is
not as per the requirement of zone IV-A.
Accelerated stability data of API is submitted.
3.2.P: Drug Product
3.2.P.1 Description and composition of drug Firm has submitted description and composition of
product drug product.
3.2.P.2 Pharmaceutical development Firm has submitted details of components of drug
products, formulation, overages, and properties,
compatibility.
3.2.P.3 Manufacture Firm has submitted detail of manufacturer, batch
intermediates.
Firm has not submitted process validation and or
evaluation.
3.2.P.4 Control of excipients Firm has provided details of specifications
(excipients and finished product), analytical
procedures, batch analysis and justification of
specifications.
Firm has not submitted data for validation of
analytical procedure and impurities characterization.
3.2.P.5 Control of drug product Firm has submitted details of specification,
3.2.P.6 Reference standard or materials Firm has provided COA of working standard
3.2.P.7 Container closure system Aluminium foil 10’s
3.2.P.8 Stability Firm has submitted stability commitment only.
Firm has not submitted stability study data
Comparative dissolution profile
4.2.1 Pharmacology Not provided
4.2.2 Pharmacokinetics Not provided
4.2.3 Toxicology Not provided
NA.
 Training evidence of technical staff with respect of manufacturing of applied drug (1.5.13) is not
provided.
 The clinical indication of Tonsillitis should not be mentioned in SmPC (1.5.14), since this
indication is covered by 100mg cefpodoxime tablet only. Moreover Justify 3 years shelf life
mentioned in SmPC and other sections.
 Justify the dosage “One tablet daily or as directed by physician” on inner label provided in 1.5.11,
since once daily dose is not recommended in any indication as mentioned in SmPC.
 Commitments of sub section 1.5.15, 1.5.16, 1.5.17, 1.5.18, 1.5.19 and 1.5.21 are not provided.
 Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance
department/section of the Manufacturer / Company (1.5.22) is not provided.
 Approval of manufacturing facility of API by regulatory body of country and validity and Vendor
qualification / audit as per 1.6.5 is not provided.
 The real time stability data of API submitted in DMF has been conducted at 25 oC ±2oC and 60% ±
5% RH, which is not as per the requirement of zone IV-A.
 Validation of analytical procedures (3.2.P.5.3) is not submitted.
 Stability study data (3.2.P.8.3) is not provided. Real-time and accelerated stability study data of 3
batches along with associated documents (documents confirming import of API, signed and
stamped chromatograms and raw data sheets) as per the requirement of 278th meeting of
Registration Board is required.
 Comparative dissolution Profile (CDP) along with reference product is not provided.
 Information required in module 4 for pharmacology (4.2.1), Pharmacokinetics (4.2.2) and
Toxicology (4.2.3) including single dose toxicity (4.2.3.1) and repeat dose toxicity (4.2.3.2) is not
provided.
 Page numbers are not mentioned on each page of the submitted dossier, similarly in Form 5-F “See
attachment” is mentioned instead of specifying the exact page number. Since Form 5-F is a legal
form therefore all details provided in this form or its annexures should be easily traceable in the
dossier.
Evaluator-PEC-VI
1180. Name, address of Applicant / Marketing M/s AGP limited, B-23-C, SITE, Karachi.
Authorization Holder
Name, address of Manufacturing site. M/s Mylan laboratories Limited, Plot No. 11,12 &
13, Indore Special Economic Zone, Pharma Zone,
Phase-II, Sector-III, Pithampur-454775 Dist. Dhar,
Madhya Pradesh, India
Status of the applicant  Manufacturer
 Importer
Dy No. and date of submission Dy No. 31739, : 24-9-2018
The proposed proprietary name / brand name HepBest 25mg tablets
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Tenofovir Alafenamide Fumarate eq to tenofovir
Alfenamide….25mg
Dosage form of applied drug Immediate release film coated tablet
Pharmacotherapeutic Group of (API) Antiviral for Systemic use, Nucleoside and
nucleotide reverse transcriptase inhibitor. ATC
Code: J05AF13
Pharmacopoeial reference In-House Formulation
Proposed Pack size 30’s
Proposed unit price Rs.6151.98 for 30’s
The status in reference regulatory authorities USFDA Approved
For generic drugs (me-too status) Not Applicable
Valid drug manufacturing license/Drug Sale Copy of Drug sale License by way of Wholesale.
License Valid till 21-09-2019 is submitted
Evidence of approval of manufacturing facility Copy of certificate of Drug registration issued from
/ approved section from licensing authority office of controller Food and drug administration,
Madhya Pradesh, India
 Generic Drug Product (GDP)
Intended use of pharmaceutical product  Domestic sale
 Export sale
 Domestic and Export sales
For imported products, please specify one of Finished Pharmaceutical Product Import
following: Bulk Import and local repacking (Specify status
of bulk)
Bulk Import local repacking for Export purpose
only
Rules, 1976
List of registered products NA
Manufacturer’s site master file and credentials Yes
(for importers)
Identification of signature of authorized persons , Incharge Production, Quality Control Yes
& Quality Assurance of manufacturer.
Training evidence of technical staff with respect of manufacturing of applied drug N/A
(mandatory in case of specially designed pharmaceutical product / Novel Dosage
Form).
Summary of Product Characteristics (SmPC) including Prescribing Information (PI) Yes
along with Patient information Leaflet (PIL) of the Finished Pharmaceuticals Product
(FPP).
Commitments Yes
Protocols along with the commitment to follow Good Laboratory Practices (GLP) by Yes
the Manufacturer.
Protocols to implement Good Pharmacovigilance Practice by the Pharmacovigilance Yes
department/section of the Manufacturer / Company.
Information on Prior-related Applications N/A
Electronic Review Package Yes
a. Name and address of API manufacturer. M/s Mylan laboratories Limited, (Unit
10) Plot No. 86- Ramky Pharmacity,
India
b. Approval of manufacturing facility of API by regulatory Form no. 26 (Certificate of renewal of
body of country and validity. license to manufacture for sale of
drugs, other than those specified in
schedule X ) is submitted. Valid upto
21-8-2022
Drug Substance Firm has submitted overall summary of drug
substance including general information,
specification, and characterization, control of the
API, reference standard, container closure system
and stability.
Drug Product Firm has submitted summary of drug product

including description and composition of drug
product, pharmaceutical development,
manufacture, control of excipients, manufacturing
process development, container closure system,
microbiological attributes and compatibility,
controls of drug product, reference standards or
materials and stability studies.
General Information Attached DMF provides details of nomenclature,
Manufacture M/s Mylan laboratories Limited, (Unit 10) Plot No.
86- Ramky Pharmacity, Andra Pradesh, India.
Firm has submitted detail of manufacturer,
manufacturing process and process control, control
of materials, control of critical steps and
intermediates, process validation / evaluation and
manufacturing process development.
Characterization Firm has provided details regarding elucidation of
Control of drug substance Firm has submitted details of specification,
analytical procedures, validation, batch analysis
and justification of specification.
Reference standards or materials Firm has submitted details of In-house Working
standard (Batch No. QCD-10/TAF/WS001/16)
Container closure system Firm has provided details on specifications for
packaging material (HMLDPE bags)
Stability Stability study data of 3 batches of API has been
provided .
Accelerated stability studies of API is conducted at
40+-2’C 75% +-5% humidity for 6 months.
3.2.P: Drug Product

Description and composition of drug product Firm has submitted description and composition of
drug product
Pharmaceutical development Firm has provided details of drug substance,
excipients, formulation development, overages,
physicochemical and biological properties,
compatibility.
Manufacture Firm has submitted detail of manufacturer, batch
intermediates, process validation and or evaluation.
Control of excipients Firm has provided details of specifications,
procedures, justification of specifications,
excipients of animal or human origin and novel
excipients.
Control of drug product Firm has submitted details of specification,
Reference standard or materials Firm has submitted certificate of analysis of
reference standards and impurity standards
Container closure system HDPE bottle with dessicant
Stability Firm has provided complete stability study data of
3 batches as per Zone IV-B
Comparative dissolution profile NA
Pharmacology Firm has provided data of pharmacology of the said
product
Pharmacokinetics Firm has provided data of pharmacokinetics of the
said product
Toxicology Firm has provided data of single dose and repeat
dose Toxicology of the said product
Firm has submitted data regarding reports of Biopharmaceutic Studies, Reports of Studies Pertinent
to Pharmacokinetics using Human Biomaterials, Reports of Human Pharmacokinetic (PK) Studies,
Reports of Human Pharmacodynamic (PD) Studies, Reports of Efficacy and Safety Studies, Reports
of Post-Marketing Experience and Case Report Forms and Individual Patient Listings.
STABILITY STUDY DATA
Manufacturer of API M/s Mylan laboratories Limited, (Unit 10) Plot No. 86- Ramky
Pharmacity, India
API Lot No. 50056945
Description of Pack
30, 90 film coated tablets packed in HDPE bottels
(Container closure system)
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 18 months
Accelerated: 6 months
Frequency Accelerated: 0, 1, 3, 5, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 2012170 2012171 2012172
Batch Size 2,30,000 Tablets 2,30,000 Tablets 2,30,000 Tablets
Manufacturing Date Aug-2016 Aug-2016 Aug-2016
Date of Initiation 25-09-2016 26-09-2016 26-09-2016
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Documents To Be Provided Status
COA of API
Yes
Approval of API by regulatory authority of country of Form no. 26 (Certificate of renewal of

origin or GMP certificate of API manufacturer issued license to manufacture for sale of drugs,
by regulatory authority of country of origin. other than those specified in schedule X ) is
submitted. Valid upto 21-8-2022
Protocols followed for conduction of stability study
Yes
and details of tests.
Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory N.A
reports, data sheets etc.
Documents confirming import of API etc. N.A
All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data / Yes
documents.
Letter Communicated to Firm Firm’s response/Remarks of the Evaluator
Real time stability data of API is not as per the 12 months API stability study is provided. The
requirements of zone IV-A Storage condition for Tenofovir Alafenamide
Fumarte is “Store ar below 25’C in tight, light-
resistant containers”. Hence long term stability
studies conducted at 25’C/ 60% RH.
Real time stability study data of Finish product 24-months Long term stability studies conducted
till complete shelf-life (24 months) is required to at 30’C / 75% are provided.
be submitted.
Product interchangeability (comparative The firm has submitted Comparative
dissolution profile) as per the requirements of Dissolutionprofile with the Reference Product
sub section 3.2.R.3 is required to be submitted. (Vemlidy 25mg tablet).
They have also provided summary of
Bioavailability and Bioequivalence studies.
Decision:
d. Import applications of priority categories defined by Registration Board in its 257th

meeting
Evaluator PEC-III
1181. Name and address of Applicant M/s Origin Pharma (Pvt) Ltd., 41-Baber Block New
Garden Town Lahore
Detail of Drug Sale License Address: 41-Baber Block, New Garden Town, Lahore
Validity: 11/08/2019
Status: License to sell drugs as distributor
Name and address of manufacturer World Medicine Ilac San Ve TiC A.S. Evren Mah. Cami
Yolu Cad. No. 50, 34212 Gunesli, Bagcilar/Istanbul.
Name and address of marketing World Medicine Ilac San Ve TiC A.S. Evren Mah. Cami
authorization holder Yolu Cad. No. 50, 34212 Gunesli, Bagcilar/Istanbul.
Name of exporting country Turkey
Type of Form Form 5-A
Diary No. & Date of R& I Dy No. 20400: 06-06-2018
Fee including differential fee PKR 50,000/-: 6-6-2018
Brand Name +Dosage Form + Fluzamed (Fluconazole 0.3% Eye Drops) (ophthalmic
Strength solution)
Fluconazole…..3mg
Finished Product Specification Firm has claimed inhouse specification
Shelf life 2 years (as per data of zone IV-A of 3 batches provided by
the firm)
Demanded Price Rs. 800/-
Pack size 5ml HDPE eye drops bottle
International availability Could not be confirmed
Detail of certificates attached  Original, legalized CoPP (No. 2018/1187) along with
translation in English issued by Turkish Medicine and
Medical Devices Agency on 26-03-2018 confirming free
sale status and GMP of the manufacturer.
 Sole agency letter between M/s World Medicine Ilac San
and M/s Origin Pharma is provided on letter head of World
medicine Ilac San.
 Evidence of approval of applied formulation in reference regulatory authorities approved in 275th
meeting is required.
 Me-too status could not be confirmed.
Decision:
Evaluator PEC-IV
1182. Name and address of M/S Bristol Mayer Biotech Pakistan, 73-B Guldasht
Applicant Town Lahore Cantt Pakistan
Detail of Drug Sale License Address : 73-B Guldasht Town, Zarar Shaheed road
Lahore
Validity : 07/04/2020
Status: to sell drugs in a whole sale distribution
Name and address of Çerkezköy Organize Sanayi Bölgesi Karaağaç Mahallesi Faith
manufacturer Bulvari No: 38 Kapakli/ TEKIRDAĞ/TURKEY
Name and address of marketing VEM ILAC San.ve Tic. A.s. Söğütözü Mahallesi 2177. Cad
authorization holder No:10 B/49 Cankaya/ANKARA/TURKEY
Diary No. & Date of R& I Dy No : 18446 Dated : 21/05/2018
Fee including differential fee Rs : 50,000 Dated : 21/05/2018
Brand Name +Dosage Form + Blumet 100mg/10ml Injection
Strength
Composition Each ml Contains
Methylene blue ……10mg
Pharmacological Group Antidote
Shelf life 36 months
Demanded Price As per SRO
Pack size 10ml Ampoule
International availability NA
Me-too status Not Available
Detail of certificates attached Valid and Legalized CoPP
Certificate No: 2018/1595
Certified by: Turkish Medicines and Medical devices
Agency Söğütözü Mahallesi 2176. Sokak No:5 06520
Cankaya/Ankara/Turkey
Product license and date of issue : 2014/442 _26.05.2014
Valid until : 25-04-2022
Free sale: Free sale of the product in exporting country.:
Yes confirms from COPP
GMP certificate
GMP certificate No : 2018/1580
Date of Issue: 24-04-2018
Valid until : 24/04/2020
Sole Contract Agreement
07-06-2018
Remarks of the Evaluator.  Long term Stability studies for only 06 months
submitted.
275th meeting.
 Refrence provided PROVAYBLUE 5mgml
(50mg/10ml) USFDA is in different strength. And
label provided of Akron, Inc. have disclaimer that this
drug has not been found by FDA to be safe and
effective, and this labelling has not been approved by
FDA.
Decision:
Evaluator PEC-V
1183. Name and address of Applicant M/s Mustafa Brothers,
186-D, Peoples Colony No.1, Faisalabad.
Detail of Drug Sale License Address: Mustafa Brothers, P-186-D, Peoples Colony
No.1 Faisalabad.
Status: License to sell drugs as a Distributor
Name and address of manufacturer M/s Asia Animal Pharmaceutical CO. LTD
No. 130, 1A Highway , Ba Lang Ward, Cai Rang District,
Can Tho City, Vietnam
Name and address of marketing M/s Asia Animal Pharmaceutical CO. LTD
authorization holder No. 130, 1A Highway , Ba Lang Ward, Cai Rang District,
Name of exporting country Vietnam
Diary No. & Date of R& I Dy. No. 14754 Dated 12/09/2017
Fee including differential fee Rs. 100,000/- Dated 12/09/2017
Brand Name +Dosage Form + Marbofloxacin 25 Solution for Injection
Strength
Marbofloxacin…25mg
Target species Cattle, Poultry
Pharmacological Group Antibacterial for systemic use, Flouroquinolones
Shelf life 3 years
Demanded Price Decontrolled
Pack size 100 ml Glass bottle
International availability International availability could not be confirmed.
Me-too status N/A
Detail of certificates attached Original Legalized Free sale Certificate
Certificate no. 260/2017/QLT-CFS
Certifying Authority: Ministry of Agriculture and Rural
Development, Department of Animal Health
Validity: 30-03-2019
Original Legalized GMP certificate
Development,
Validity: Aug 2022.
Copy of Distribution Agreement
M/s Mustafa Brothers
&
M/s Asia Animal Pharmaceutical CO. LTD
Validity: 24, Aug, 2021
Stability Studies  Zone IV A.
36 months data.
Remarks of the Evaluator.  Step of terminal sterilization has not been mentioned in
manufacturing outline. Justify and clarify the same.
Firm has used filtration process through micro filter (1
mm-0.2mm) filter.
 Agreement does not mention the list of product to be
imported.
Decision:
1184. Name and address of Applicant M/s Mustafa Brothers,
Detail of Drug Sale License Address: Mustafa Brothers, P-186-D, Peoples Colony
No.1 Faisalabad.
Name and address of manufacturer M/s Asia Animal Pharmaceutical CO. LTD
Name and address of marketing M/s Asia Animal Pharmaceutical CO. LTD
authorization holder No. 130, 1A Highway , Ba Lang Ward, Cai Rang District,
Name of exporting country Vietnam
Brand Name +Dosage Form + Thiamsone Injectable Solution
Strength
Thiamphenicol …100mg
Oxytetracycline…50mg
Dexamethasone…. 1mg
Target species Cattle, Poultry
Pharmacological Group Antibacterial for systemic use
Shelf life 3 years
Pack size 100 ml Glass bottle
International availability International availability could not be confirmed.
Me-too status N/A
Detail of certificates attached Original Legalized Free sale Certificate
Certificate no. 262/2017/QLT-CFS
Development, Department of Animal Health
Original Legalized GMP certificate
Development,
Validity: Aug 2022.
Agreement
M/s Mustafa Brothers,
&
M/s Asia Animal Pharmaceutical CO. LTD
Validity: 24, Aug, 2021
Stability Studies  Zone IV A.
36 months data.
Remarks of the Evaluator.  Step of terminal sterilization has not been mentioned in
manufacturing outline. Justify and clarify the same.
Firm has used filtration process through micro filter (1
mm-0.2mm) filter.
 Agreement does not mention the list of product to be
imported.
Decision:
Evaluator PEC-VIII
1185. 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:
Status: Drug License by way of Wholesale
Name and address of Reliance Life sciences Pvt Ltd., Plant 3,5,6, Dhirubhai life
manufacturer 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,
Name of exporting country India
Type of Form Form 5A
Diary No. & Date of R& I Dy. No.3409 Dated 26/01/2018
Brand Name +Dosage Form + Erlotirel 100 Tablets
Strength
Erlotinib……. 100mg
Finished Product Specification In House
Pharmacological Group Anti-Cancer
Demanded Price As Per MRP
Pack size
International availability Approved in US-FDA
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
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.
Original legalized Free sale Certificate:
(This certificate is issued for export registration)
Certificate No: 6078190
Certified by: Food & Drugs Administration Konkan Division,
Maharashtra State, India.
Issued date: 24/10/2017
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.
Decision:
1186. 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 Reliance Life sciences Pvt Ltd., Plant 3,5,6, Dhirubhai life
manufacturer 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,
Type of Form Form 5A
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
International availability Approved in US-FDA
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.
Decision:
Evaluator PEC-XII
1187. Name and address of Applicant M/s Punjab Medical Services,
Office No. 4,5 Jalal Centre 2nd floor Opposite O.P.D gate Sir
Ganga Ram Hospital Lahore
Detail of Drug Sale License Adress: Punjab Medical Services Pharmacy, Office No. 4,5
Jalal Centre 2nd floor Opposite O.P.D gate Sir Ganga Ram
Hospital Lahore
Status: License to sell drugs in Pharmacy
Name and address of manufacturer M/s Actavis Italy S.P.A,
Nerviano plant, Viale Pasteur 10 20014, Nerviano (milan),
Italy.
Name and address of marketing M/s Actavis Group PTC ehf.
authorization holder Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.
Name of exporting country Iceland
Diary No. & Date of R& I Dy No.25077 : 19-07-2018
Brand Name +Dosage Form + EPI PMS, 10mg/5ml Solution for Injection
Strength
Epirubicin hydrochloride …10 mg
Pharmacological Group Cytotoxic antibiotics and related substances (Anthracyclines
and related substances)
Pack size Type I glass vials containing 5ml concentrated solution in
pack size of 1’s
International availability Epirubicin hydrochloride 2 mg/ml, solution for injection or
infusion (5ml vial) by M/s Teva UK Limited (MHRA
Approved)
Me-too status Ciazil Injection 10mg vial (5ml) by M/s Rotex (Reg#063978)
Detail of certificates attached Original, Legalized CoPP
Certifying Authority: Icelandic Medicines Agency
Free Sale: Yes
Issue Date: 16-03-2018
Copy of GMP certificate
Certificate No: IT/130-1/H/2016
Certifying Authority: Agenzia Italiana del farmaco (AIFA)
Date of inspection: 05-10-2016
Validity : 3 years
Letter of Authorization
Firm has submitted letter of Authorization from M/s Actavis
Group PTC ehf.Iceland for the applied product in the name of
M/s Punjab Medical Services, Office No. 4,5 Jalal Centre
2nd floor Opposite O.P.D gate Sir Ganga Ram Hospital
Lahore
Issue date: 25-09-2018
 Manufacturer has cytotoxic section.
 Drug product is intended for storage in a refrigerator as per ICH guideline.
Study Storage condition Minimum time period covered by
data at submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C/60% RH ± 5% RH 6 months
 Firm has submitted stability study data of 2 batches. Details are as under:
Batch#31010
Long term (5°C ± 3°C) 36 months duration.
Accelerated (25°C ± 2°C/60% RH ± 5% RH) 2 months duration. (As per documents submitted
by the firm significant changes: a 5%change in assay from its initial value. T3 and T6 months
were not tested because the stability was interrupted after T2 months failure.
Batch#31020
by the firm significant changes: a 5%change in assay from its initial value at T3 and T6 months).
Batch#31030
were not tested because the stability was interrupted after T2 months failure).
As per ICH HARMONISED TRIPARTITE GUIDELINE: STABILITY TESTING OF

NEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2) for Drug substances intended for
storage in a refrigerator:
If significant change occurs between 3 and 6 months’ testing at the accelerated storage condition,
the proposed re-test period should be based on the real time data available at the long term
storage condition.
If significant change occurs within the first 3 months’ testing at the accelerated storage condition,
a discussion should be provided to address the effect of short term excursions outside the label
storage condition, e.g., during shipping or handling. This discussion can be supported, if
appropriate, by further testing on a single batch of the drug substance for a period shorter than 3
months but with more frequent testing than usual. It is considered unnecessary to continue to test
a drug substance through 6 months when a significant change has occurred within the first 3
months.
 The finished product analytical procedure submitted by the firm refers to in-house method for the
‘Assay’ test, whereas USP and BP monograph available for applied formulation.
Decision:
1188. Name and address of Applicant M/s Punjab Medical Services,
Office No. 4,5 Jalal Centre 2nd floor Opposite O.P.D gate Sir
Ganga Ram Hospital Lahore
Detail of Drug Sale License Adress: Punjab Medical Services Pharmacy, Office No. 4,5
Jalal Centre 2nd floor Opposite O.P.D gate Sir Ganga Ram
Hospital Lahore
Status: License to sell drugs in Pharmacy
Name and address of manufacturer M/s Actavis Italy S.P.A,
Nerviano plant, Viale Pasteur 10 20014, Nerviano (milan),
Italy.
Name and address of marketing M/s Actavis Group PTC ehf.
authorization holder Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.
Name of exporting country Iceland
Diary No. & Date of R& I Dy No.25076 : 19-07-2018
Brand Name +Dosage Form + EPI PMS, 50mg/25ml Solution for Injection
Strength
Epirubicin hydrochloride …50 mg
Pharmacological Group Cytotoxic antibiotics and related substances (Anthracyclines
and related substances)
Pack size Type I glass vials containing 25ml concentrated solution in
pack size of 1’s
International availability Epirubicin hydrochloride 2 mg/ml, solution for injection or
infusion (25ml vial) by M/s Teva UK Limited (MHRA
Approved)
Me-too status Ciazil Injection 10mg vial (5ml) by M/s Rotex (Reg#063978)
Detail of certificates attached Original, Legalized CoPP
Certifying Authority: Icelandic Medicines Agency
Free Sale: Yes
GMP: n/a
Copy of GMP certificate
Certificate No: IT/130-1/H/2016
Certifying Authority: Agenzia Italiana del farmaco (AIFA)
Validity : 3 years
Copy of Letter of Authorization
Firm has submitted letter of Authorization from M/s Actavis
Group PTC ehf.Iceland for the applied product in the name of
M/s Punjab Medical Services, Office No. 4,5 Jalal Centre
2nd floor Opposite O.P.D gate Sir Ganga Ram Hospital
Lahore
 Manufacturer has cytotoxic section.
 Drug product is intended for storage in a refrigerator as per ICH guideline.
Study Storage condition Minimum time period covered by
data at submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C/60% RH ± 5% RH 6 months
 Firm has submitted stability study data of 2 batches. Details are as under:
Batch#2CK001
were not tested because the stability was interrupted after T2 months failure.)
Batch#2CK002
were not tested because the stability was interrupted after T2 months failure).
Batch#3CK001
by the firm significant changes: a 5%change in assay from its initial value at T6 months).
As per ICH HARMONISED TRIPARTITE GUIDELINE: STABILITY TESTING OF

NEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2) for Drug substances intended for
storage in a refrigerator:
If significant change occurs between 3 and 6 months’ testing at the accelerated storage condition,
the proposed re-test period should be based on the real time data available at the long term
storage condition.
If significant change occurs within the first 3 months’ testing at the accelerated storage condition,
a discussion should be provided to address the effect of short term excursions outside the label
storage condition, e.g., during shipping or handling. This discussion can be supported, if
appropriate, by further testing on a single batch of the drug substance for a period shorter than 3
months but with more frequent testing than usual. It is considered unnecessary to continue to test
a drug substance through 6 months when a significant change has occurred within the first 3
months.
 The finished product analytical procedure submitted by the firm refers to in-house method for the
‘Assay’ test, whereas USP and BP monograph available for applied formulation.
Decision:
Evaluator PEC-XIV
nd
1189. Name and address of Applicant M/s AA pharma, 2 floor, Shafi Court, Merewether
Road, Civil Lines, Karachi
Detail of Drug Sale License Address: A-16 Block-13, Gulistan e Iqbal, Karachi
Status: License to sell drugs by way of wholesale
Name and address of manufacturer M/s Jiangsu Hengrui Medicine Co., Ltd. 38 Huanghe
Road, Economic and technical development Zone,
Lianyungang, Jiangsu 222047, China.
Name and address of marketing M/s Jiangsu Hansoh pharmaceutical group Co., Ltd. No.9
authorization holder Dongjin Roaf, Economic and technical development Zone,
Name of exporting country China
Diary No. & Date of R& I Dy No. 26100, Dated 30-07-2018
Fee including differential fee PKR 100,000/-, Dated 19-07-2018
Brand Name +Dosage Form + Strength ZEFEI 200mg for injection
Gemcitabine Hydrochloride eq. to Gemcitabine.......200mg
Pharmacological Group Nucleoside metabolic inhibitor
Demanded Price ------
Pack size 10 ml Type I glass vial, 1’s
International availability Gemcitabine 200mg solution for infusion of Accord
healthcare Ltd., MHRA approved
Me-too status Oncogem 200 Injection by AJ Mirza Pharma
(Reg#045671)
Detail of certificates attached ● Original legalized CoPP issued by Jiangsu Provincial
Food and Drug Administration, China confirms free sale
of the product in the exporting country. Certificate No:
LYG(copp)20180019.
● Notarised GMP certificate of the manufacturer issued by
China Food and Drug Administration is submitted which
is valid until 22-05-2019. Certificate No: CN20140247.
● Legalized copy of letter of authorization dated 15-03-
2018 has been submitted from M/s Jiangsu Hansoh
Pharmaceutical Group Co., Ltd, China declaring M/s
AA Pharma, 2nd floor, Shafi Court, Merewether
Road, Civil Lines, Karachi do authorize for importation
and distribution of the product in the territory of
Pakistan.
Remarks of the Evaluator.  The firm has submitted 36 months real time stability
study data for 3 batches
Batch # 16111512
Batch # 16111912
Batch # 16112312
 The firm has submitted 06 months accelerated stability
study data and 12 months real time stability data for
following 3 batches
Batch # 14100512
Batch # 14100712
Batch # 14101112
Decision:
1190. Name and address of Applicant M/s AA pharma, 2nd floor, Shafi Court, Merewether
Road, Civil Lines, Karachi
Detail of Drug Sale License Address: A-16 Block-13, Gulistan e Iqbal, Karachi
Name and address of manufacturer M/s Jiangsu Hengrui Medicine Co., Ltd. 38 Huanghe
Road, Economic and technical development Zone,
Name and address of marketing M/s Jiangsu Hansoh pharmaceutical group Co., Ltd. No.9
authorization holder Dongjin Roaf, Economic and technical development Zone,
Name of exporting country China
Diary No. & Date of R& I Dy No. 26099, Dated 30-07-2018
Fee including differential fee PKR 100,000/-, Dated 23-07-2018
Brand Name +Dosage Form + Strength ZEFEI 1g for injection
Gemcitabine Hydrochloride eq. to Gemcitabine.......1g
Finished Product Specification Nucleoside metabolic inhibitor
Pharmacological Group USP
Demanded Price ------
Pack size 10 ml Type I glass vial, 1’s
International availability Gemcitabine 1g solution for infusion of Accord healthcare
Ltd., MHRA approved
Me-too status Oncogem 1g Injection by AJ Mirza Pharma (Reg#045672)
Detail of certificates attached ● Original legalized CoPP issued by Jiangsu Provincial
Food and Drug Administration, China confirms free sale
of the product in the exporting country. Certificate No:
LYG(copp)20180019.
● Notarised GMP certificate of the manufacturer issued by
China Food and Drug Administration is submitted which
is valid until 22-05-2019. Certificate No: CN20140247.
● Legalized copy of letter of authorization dated 15-03-
2018 has been submitted from M/s Jiangsu Hansoh
Pharmaceutical Group Co., Ltd, China declaring M/s
AA Pharma, 2nd floor, Shafi Court, Merewether
Road, Civil Lines, Karachi do authorize for importation
and distribution of the product in the territory of
Pakistan.
Remarks of the Evaluator.  The firm has submitted 12 months real time stability
study data for 3 batches
Batch # 15102812
Batch # 16060712
Batch # 16120212
 and 06 months accelerated stability study data for
following 3 batches
Batch # 14111212
Batch # 14111612
Batch # 14112012
Decision:
Case No. 07: Registration applications of import cases
a. New Cases (Human)

Evaluator PEC-VI
1191. Name and address of M/s Mustafa Brothers 186-D Peoples Colony No.1
Detail of Drug Sale License Address:P-1860-D, Peoples Colony No.1 Faisalabad
Validity : 12/2/2019
Status: License to sell drugs as a distributor
Name and address of M/s Asia Animal Pharmaceutical Co. Ltd
manufacturer Address: No.130-1A Highway-Ba Lang Ward – Cai
Rang District – CanTho
City: Viet Nam.
Name and address of marketing M/s Asia Animal Pharmaceutical Co. Ltd
authorization holder Address: No.130-1A Highway-Ba Lang Ward – Cai
City: Viet Nam.
Name of exporting country Viet Nam
Brand Name +Dosage Form + Terramycin La
Strength Solution For Injection
Composition Each ml contains :
Oxytetracycline HCL…..200mg
Shelf life 3 Years (As packaged for sale)
14 days (After first opening the immediate packaging)
Pack size 100ml
Me-too status FLOXYTETRA L.A INJECTABLE SOLUTION Reg #
017137
Detail of certificates attached Free sale Certificate: Issued by Ministry of
Agriculture and Rural development and is valid until
29-3-2019
GMP certificate
Copy of GMP certificate issued from Ministry of
Agriculture and Rural development/Socialist Republic
of Viet Nam and is valid until 31 July 2022.
Remarks of the Evaluator. 3 batches tested at Accelerated stability (40’C+-2’C and
75% RH +-5%) for 6 months and Long term stability
(30’C+-2’C and 65% RH +-5%) for 3years or 36months
a) 0112 Manufacturing date 24 March 2012
b) 0212 Manufacturing date 25 March 2012
c) 0312 Manufacturing date 26 March 2012
Decision:
City: Viet Nam.
City: Viet Nam.
Brand Name +Dosage Form + Analgin C
Analgin……250mg
Vitamin C……100mg
Pharmacological Group Antipyretic, Antiinflammatory
Pack size 100ml
29-3-2019
GMP certificate
d) 0111 Manufacturing date March 2011
e) 0211 Manufacturing date March 2011
f) 0311 Manufacturing date March 2011
Analgin is a synonym of metamizole (a banned drug)
Decision:
City: Viet Nam.
City: Viet Nam.
Brand Name +Dosage Form + Ivermectin
Ivermectin…..10mg
Pack size 100ml.
Me-too status MECTIVER 1% INJECTION Reg # 014537
29-3-2019
GMP certificate
g) 0110 Manufacturing date 16th March 2010
h) 0210 Manufacturing date 17th March 2010
i) 0310 Manufacturing date 18th March 2010
Decision:
Evaluator PEC-VII
1. Name and address of Applicant M/S Bristal Mayer Biotech Pakistan, 73-B Guldasht
town, Zarrar Shaheed road, Lahore Cantt
Detail of Drug Sale License Address: M/S Bristal Mayer Biotech Pakistan, 73-B
Guldasht town Zarrar Shaheed road, Lahore Cantt
Pakistan
Validity: 7-April- 2020
Status: License to sell drug as distributor
Name and address of manufacturer Vem ilac San. Ve Tic. A.S.
Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mahallesi. Fatih Bulvari. No 38
Kapakli/TEKIRDAG/Turkey
Name and address of marketing Vem ilac San. Ve Tic. A.S.
authorization holder Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mah. Fatih Blv. No 38 Kapakli/TEKIRDAG/Turkey
Diary No. & Date of R& I Dy. No.14613 Dated 19-01-2018
Fee including differential fee Rs. 50,000/- Dated 19-04-2018
Brand Name +Dosage Form + Strength Blumet I.V Solution for injection 50 mg/ 5ml
Composition Each 1 ml solution contain
Methylene Blue…. 10 mg
Pharmacological Group Antidotes; Other diagnostic agents
Shelf life 36 Months
Demanded Price NA
Pack size 5 ml glass ampoule of Type 1
International availability NA
Me-too status NA
Detail of certificates attached COPP (Original, Embassy Attested)
Certificate No:2018/15g6
Certifying Authority: Ministry of health Turkish
medicine and medical devise agency
Valid Date:25-4-2020
Letter of Authorization (original)
Date of Agreement:7-06-2018 (Valid for 5 year)
Free sale (Original, Embassy Attested)
Certificate No:2018/1581
Remarks of the Evaluator VII • Stability is at 45°C ± 2°C / 75% ± 5% RH (6
months) and 30°C ± 2°C / 65% ± 5% RH (6 months) for
3 batches is provided. (Stability starting date: 11-7-2016)
• Evidence of approval of applied formulation in
reference regulatory authorities not available.
PROVAYBLUE 5 mg/ ml (50 mg/ 10 ml) (USFDA) is in
different strength and provided label of 10 mg/ml itself
claimed this drug is not found to be effective and safe by
USFDA and this label is not approved by fda.
Decision:
2. Name and address of Applicant M/S Bristal Mayer Biotech Pakistan, 73-B Guldasht
town, Zarrar Shaheed road, Lahore Cantt
Detail of Drug Sale License Address: M/S Bristal Mayer Biotech Pakistan, 73-B
Guldasht town Zarrar Shaheed road, Lahore Cantt
Pakistan
Validity: 7-April- 2020
Status: License to sell drug as distributor
Name and address of manufacturer Vem ilac San. Ve Tic. A.S.
Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mah. Fatih Blv. No 38 Kapakli/TEKIRDAG/Turkey
Name and address of marketing Vem ilac San. Ve Tic. A.S.
authorization holder Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mahallesi. Fatih Bulvari. No 38
Kapakli/TEKIRDAG/Turkey
Brand Name +Dosage Form + Strength Fuxesin 100 mg injection
Composition Each vial contain
Anidulafungin…. 100 mg
(Lyophilized powder for solution for infusion)
Shelf life 24 Months (2-8 ºC)
Pack size 20 ml, 50 ml, 100 ml Clear glass vial Type-I
International availability Ecalta 100 milligram(s) Powder and solvent for solution
for infusion Pfizer Europe (MHRA)
Me-too status NA
Detail of certificates attached COPP (Original, Embassy Attested)
Letter of Authorization (Original)
Date of Agreement:1-01-2016 (Valid for 5 year)
Free sale ( Original, Embassy Attested)
Remarks of the Evaluator VII  Stability is at 5°C ± 3°C (24 months) and 25°C ±
2°C / 60% ± 5% RH (for 3 batches)
 Innovator, ERAXIS for Injection unreconstituted
vials and companion diluent vials should be stored at 2-
8ºC; Excursions for 96 hours up to 25°C are permitted
Decision:
b. New Cases (Veterinary) Evaluator PEC-II

1194. Name and address of Applicant M/s Saadat International, 117-Habitat Apartment,
Shadman-II Jail Road, Lahore.
Detail of Drug Sale License Address: Saadat International, 117-Habitat Apartment,
Shadman-II Jail Road, Lahore.
Name and address of M/s Merial 23 Rue Du Prieure, 44150 St Herblon, France.
manufacturer
Name and address of marketing M/s Merial 29 Avenue Tony Garnier, 69007 Lyon
authorization holder No. of product license: FR/V/8415906 9/1996 dated 13-09-1996
Name of exporting country France
Brand Name +Dosage Form + Cofacoli solution
Strength
Colistin (as sulphate)……. 2,000,000 IU
Finished Product Specification Manufacturer specifications.
Pharmacological Group Intestinal anti-infective agent
Demanded Price De-controlled
Pack size 1ltr. & 5ltr.
International availability Not applicable
Me-too status N/A
Detail of certificates attached  Original Legalized Certificate for a Veterinary
Medicinal Product (Certificate No. 18-208889)
Certified by: Agence nationale du medicament veterinaire
(anses) France
Issued on: 28-06-2018
GMP: The facilities and operations conform to GMP as
 Legalized copy of GMP certificate issued by Agence
nationale du medicament veterinaire (anses) France in the
name of s Merial 23 Rue Du Prieure, 44150 St Herblon, France,
valid upto June, 2020.
 Notarized copy of “Letter of Appointment” has been
submitted in which M/s Merial SAS has appointed M/s
Saadat International, Lahore, Pakistan as official
representative and sole agent in Pakistan for applied
formulation, dated 22-06-2018.
Remarks of the Evaluator.  Firm has submitted 36 months long term stability data as per
Decision:
Evaluator PEC-V
1195. Name and address of Applicant M/s Fair International Trading Co.
11 A-Syed Arcade, 2nd floor, Block 5, Gulshan e Iqbal, Karachi
Detail of Drug Sale License Address: D-94, Block 7, Gulshane Iqbal, Karachi
Status: Way of Wholesale
Name and address of M/s Cenavisa, S.L. 43205-RUES/Spain Cami Pedra Estela, s/n
manufacturer
Name and address of marketing M/s Cenavisa, S.L. 43205-RUES/Spain Cami Pedra Estela, s/n
authorization holder
Name of exporting country Spain
Brand Name +Dosage Form + CENAMICINA FORTE 100mg
Strength Solution for use in drinking water
Enrofloxacin…….. 100mg
Target species Chicken (broilers)
Pharmacological Group Anti-microbial
Shelf life 3 years
Pack size 100ml bottle, 1 litre bottle, 5 litre barrel
HDPE bottles
International availability Baytril 10% Oral Solution by M/s Baeyer PLC UK Approved
Me-too status Enflox 10% solution by M/s Alina combine Pakistan (Reg #
035157)
Detail of certificates attached  Original Legalized CoPP
Certificate No. 752/2018
Certifying Authority: Agencia Espanola de medicaomentos Y
productos sanitarios
Date of Issue: 30-10-2018
 GMP certificate (certificate No. ES/177HV/15)
certified by Agencia Espanola de medicaomentos Y productos
sanitarios issued on 31/05/2016.
 Distribution Agreement
Dated: 05-011-2018
Validity: 3 years
Stability data Batch no. 07201/13 (DOM:01-2013), 07202/13 (DOM:02-
2013),,07205/13(DOM:03-2013),
Remarks of the Evaluator.  The firm has claimed In House specifications and the
product is not present in BP/USP.
 Clarification for change in address mentioned on
drug sale license and Form 5 A.
Firm has submitted that address mentioned on DSL is their
warehouse and on Form 5A is office address.
• Submit valid GMP certificate as provided one is not
valid.
CENAVISA S.L. stablished in Cami Pedra Estela s/n in
Reus/Spain, certifies that GPM certificate submitted with
Application form for the registration procedure of
CENAMICINA FORTE on the year 2016, was valid until
01/07/2018.
During this current year 2018, CENAVISA S,L. have been
updating its facilities (Injectable line), for this reason, Spanish
Authorities gave us an extension for this Certificate until
01/01/2019.
Next year, form that data, our authorities will conduct a new
inspection to our factory and CENAVISA S.L. expect to be
authorized and renew once again the GMP certification.
Shortcomings
 Long term stability studies conducted under the
conditions of zone IV-A of 03 batches till shelf life
along with the supporting document,
chromatograms, raw data sheets etc as the provided
data at condition IVA mentions the same batches as
submitted initially at condition II. Clarification is
also required in this regard.
Firm has submitted long term stability data as per Zone IVA
but the supporting documents i.e. chromatograms does not
support the datasheets.There are following observations in the
submitted data.
o The sample injection of all time points seems
to be run on same day,
o The firm has not submitted standard
chromatograms, the peaks are not symmetrical,
retention time vary at different time points.
o The submitted sample chromatograms are at
following time points 0,12,24,36M.
o Firm has not submitted raw data sheets.
o Firm has not submitted clarification.
Hence, the supporting data seems to be false.
Decision:
Evaluator PEC-III
1196. 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.
Name and address of manufacturer Alfasan Nederland B.V. Kuipersweg 9, 3449 JA Woerden
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 + Alfamec 1% solution for injection
Strength
Ivermectin……..10mg
Finished Product Specification Firm has claimed inhouse specification while the finished
product monograph is available in BP/USP
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, 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 4th 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
manufacturer since Form 5-A specify Alfasan from Alfasan International stating that as per
International as manufacturer, while the agreement between Alfasan Nederland and
manufacturer mentioned in CoPP is Alfasan Alfasan International BV it is agreed that
Nederland, and the GMP certificate submitted is Alfasan International is allowed to export the
also of Alfasan International B.V. Furthermore product for which Alfasan Nederland BV is the
the sole agency agreement is with M/s Alfasan registration holder.
International B.V, which is product license Firm has further stated that Alfasan is a
holder in country of origin, justification in this multilayer group of companies all based in same
regard is also required. physical 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
3 batches as per the conditions of Zone IV-A, batches 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:
Road Lahore.
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)
manufacturer.
is also submitted.

holder in country of origin, justification in thismultilayer group of companies all based in same
Real time and accelerated stability study data of Firm has submitted stability study data of 3
3 batches as per the conditions of Zone IV-A, batches at 30oC and 65% RH. The batches were
since the submitted stability studies are manufactured in 2012.
Decision:
Road Lahore.
Netherlands
Type of Form Form 5-A;
Brand Name +Dosage Form + Amoxycilline 20% LA suspension for injection
Strength
Composition Each ml suspension contains:
Amoxycillin trihydrate………..200mg
product monograph is available in USP/BP
Pharmacological Group Antibacterial for systemic use
Me-too status Novamox 20% LA Injection by Selmore
manufacturer.
is also submitted.

3 batches as per the conditions of Zone IV-A, batches at 30oC and 65% RH.
Firm has submitted that the manufacturer has performed stability testing as per BP monograph
Decision:
Road Lahore.
Netherlands
Brand Name +Dosage Form + Xylazine 2% solution for injection
Strength
Xylazine (as hydrochloride)………..20mg
product monograph is available in USP.
Pharmacological Group Hypnotics and sedatives
Pack size 30ml vial
Me-too status Xylaz Injection by Prix Pharma (Reg # 013246)
manufacturer.
is also submitted.

holder in country of origin, justification in this multilayer group of companies all based in same
3 batches as per the conditions of Zone IV-A, batches at 30oC and 65% RH.
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.
Decision:
Road Lahore.
Netherlands
Brand Name +Dosage Form + Multivitamin solution for injection
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
product monograph is not available in any pharmacopoeia.
Pharmacological Group Multivitamins
Shelf life 36 months (Data not as per zone IV-A)
manufacturer.
is also submitted.

3 batches as per the conditions of Zone IV-A, batches at 30oC and 65% RH. The batches were
since the submitted stability studies are manufactured in 2012.
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
Decision:
Road Lahore.
Netherlands
Brand Name +Dosage Form + Tylosin 20% solution for injection
Strength
Tylosin (as tartrate)……..200mg
Finished Product Specification BP Specs
Pack size 100ml
Me-too status Tylowan 20 Injection by Nawan Pharma (Reg # 025356)
manufacturer.
is also 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
Decision:
1202. Name and address of Applicant M/s Unicare Enterprises Plot No. 587/1-B, street No. 3,
Punjab Small Industrial Estate, Nalka Kohala, Sargodha
Road, Faisalabad.
Detail of Drug Sale License Address: Plot No. 587/1-BStreet No. 3 Punjab Small
Industrial Estate, Nalka Kohala, Sargodha Road, Faisalabad
Status: License to sell drugs as “distributor”
Name and address of manufacturer Laboratorios Karizoo S.A. Pol. Ind. La Borda, Mas Pujades,
11-12 08140 Caldes de Montbui Barcelona Spain
Name and address of marketing Laboratorios Karizoo S.A. Pol. Ind. La Borda, Mas Pujades,
authorization holder 11-12 08140 Caldes de Montbui Barcelona Spain
Brand Name +Dosage Form + Flortek 100mg/ml (solution for oral administration)
Strength
Florfenicol……100mg
Pharmacological Group Antimicrobials for systemic use
Shelf life 36 months but not supported with data
Pack size 500ml, 1L, 5L
International availability Approved and available in Spain
Me-too status Naflor 100mg/ml Oral solution by Nawan Pharma (049514)
Detail of certificates attached GMP Certificate:
Copy of GMP certificate (No. ES/189HV/16) is provided by
the firm which states inspection conducted on 19-10-2016.
The GMP certificate has been verified from Eudra GMP
database as well.
COPP:
Original, legalized CoPP confirming free sale and GMP of
the manufacturer issued by Departmento de medicamentos
Veterinarios Parque Empresarial Madrid Spain dated 21 July
2016 is provided.
Sole Agency Agreement:
Copy of sole agency agreement between the MA holder in
Spain and applicant in Pakistan is provided.
Following observations were forwarded to the applicant and the response received is as follows:
Observations Response by the firm
Justify the use of this product in poultry (as Firm has submitted that this is a generic drug
claimed in your label), since this drug is and following registered products are already
approved in country of origin and reference being effectively used in poultry.
regulatory authority i.e. Spain for use in pigs for 1. Naflore by Nawan Laboratories (049514)
the treatment and prevention at the group level 2. Neflox by Selmore (049647)
where clinical signs of swine respiratory disease 3. Rivaflor 100 by Mylab (074100)
associated with Actinobacillus Firm has submitted copy of EMA report of
pleuropneumoniae and Pasteurella multocida committee for veterinary medicinal products for
sensitive to florfenicol are present. extension of florfenicol to chicken. This reports
concludes the recommendation of inclusion of
florfenicol for chicken with following condition:
Not for use in animals from which eggs are
produced for human consumption
Justify the claimed shelf life of 36 months, since Firm has requested that the same shelf life as
the submitted stability data is not conducted as approved in country of origin may be granted.
per the requirements of Zone IV-A, furthermore Firm has not submitted stability study data at
the submitted stability data concludes that the the conditions of zone IV-A.
product is not within established limits when
kept for accelerated stability testing and thus
proposes a shelf life of 18 months with specific
recommendation to not store product above
25oC. The shelf life approved by the country of
origin for this product is also 18 months.
Decision:
1203. Name and address of Applicant M/s Unicare Enterprises Plot No. 587/1-B, street No. 3,
Punjab Small Industrial Estate, Nalka Kohala, Sargodha
Road, Faisalabad.
Detail of Drug Sale License Address: Plot No. 587/1-BStreet No. 3 Punjab Small
Industrial Estate, Nalka Kohala, Sargodha Road, Faisalabad
Status: License to sell drugs as “distributor”
Name and address of manufacturer Laboratorios Karizoo S.A. Pol. Ind. La Borda, Mas Pujades,
11-12 08140 Caldes de Montbui Barcelona Spain
Name and address of marketing Laboratorios Karizoo S.A. Pol. Ind. La Borda, Mas Pujades,
authorization holder 11-12 08140 Caldes de Montbui Barcelona Spain
Brand Name +Dosage Form + Karidox 500mg/g water soluble powder
Strength
Composition Each gram powder contains:
Doxycycline (as hyclate)……..500mg
Pharmacological Group Semi synthetic tetracycline
Pack size 200g, 1Kg thermosealed bag
International availability Approved and available in Spain
Detail of certificates attached GMP Certificate:
Copy of GMP certificate (No. ES/189HV/16) is provided by
the firm which states inspection conducted on 19-10-2016.
The GMP certificate has been verified from Eudra GMP
database as well.
COPP:
Original, legalized CoPP confirming free sale and GMP of
the manufacturer issued by Departmento de medicamentos
Veterinarios Parque Empresarial Madrid Spain dated 21 July
2016 is provided.
Sole Agency Agreement:
Copy of sole agency agreement between the MA holder in
Spain and applicant in Pakistan is provided.
Following observations were forwarded to the applicant and the response received is as follows:
Observations Response by the firm
Justify the use of this product in calves and Firm has submitted that this is a generic product
poultry for treatment of fowl cholera, coryza, and widely used in poultry and cattle in Pakistan
infectious synovitis, avian spirochaetosis, and international reference countries.
colibacillosis, salmonellosis, necrotic enteritis,
ornithosis, coli diarrhea and liver abscess. (as
claimed in your label), since this drug is
approved in country of origin and reference
regulatory authority i.e. Spain for use in Porcine
for the treatment of clinical respiratory
infections caused by strains of Mycoplasma
hyopneumoniae and Pasteurella multocida
sensitive to doxycycline and in Birds (Chickens
and turkeys) for the treatment of clinical
respiratory infections associated with
Mycoplasma gallisepticum sensitive to
doxycycline.
Justify the claimed shelf life of 36 months, since Firm has requested that the same shelf life as
the submitted stability data proposed a shelf life approved in country of origin may be granted.
of 24 months while the shelf life approved by Firm has not submitted stability study data at
the country of origin for this product is the conditions of zone IV-A.
18months.
Evidence of applied formulation/drug already Firm has submitted three references for me-too
approved by DRAP (generic/ me-too status) status, none of them could be verified from
along with registration number, brand name and database.
name of firm
Decision:
Evaluator PEC-VIII
1204. 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.
Status: Licence to sell as a “Distributer”
Name and address of M/s Bela Pharm GmbH & Co.KG LohnerStrasse 19
manufacturer 49377 Vechta, Germany.
Name and address of marketing M/s Bela Pharm GmbH & Co.KG LohnerStrasse 19
authorization holder 49377 Vechta, Germany.
Name of exporting country 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 months
Demanded Price De-Controlled
Pack size 500gm, 1kg
International availability Could not be confirmed
Me-too status N/A
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.
GMP: The facilities and operations conform to GMP as
Letter of authorization
Vet line international &Bela Pharm GmbH.
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.
Decision:
c. Deferred cases
i. Human
Evaluator PEC-II
Following cases previously presented in 284th meeting of Registration Board are reproduced here:
1205. Name and address of Applicant M/s Fresenius Medical Care Pakistan (Private) Ltd. TAMC,
First Floor, 27-C III, M.M. Alam Road Gulberg III, Lahore
54660,Pakistan
Detail of Drug Sale License Copy of DSL of M/s Fresenius Medical Care Pakistan (Private)
Ltd. TAMC, First Floor, 27-C III, M.M. Alam Road Gulberg III,
Lahore 54660,Pakistan (No. 05-352-0065-028601D) issued by
Chief Drugs controller valid upto 27-02-2020
Name and address of M/s Fresenius Medical Care Deutschland GmbH, 66606 St.
manufacturer Wendel / Germany
Name and address of marketing M/s Fresenius Medical Care Deutschland GmbH Else-Kroner-
authorization holder Straße 1 61352 Bad Homburg v.d.H./Germany.
MA. No: 50132.00.00 dated 19.02.2002

Diary No. & Date of R& I Dy. No. 13004-B Dated 09-04-2018
Brand Name +Dosage Form + multiBic 2 mmol/l potassium solution for
Strength haemodialysis/haemofiltration
Composition BEFORE MIXING
Each 1000ml solution contains:
I. Acidic electrolyte, glucose solution

(small compartment)
Active substances:
Potassium chloride=2.982 g
Calcium chloride dihydrate=4.410 g
Magnesium chloride hexahydrate=2.033 g
Glucose monohydrate(=anhydrous glucose 20.00 g)=22.00 g
K+ = 40 mmol
Ca2+ = 30 mmol
Mg2+ = 10 mmol
Cl- = 122 mmol
Glucose = 111 mmol
II. Alkaline hydrogen carbonate solution

(large compartment)
Active substances:
Sodium chloride=6.453 g
Sodium hydrogen carbonate=3.104 g
Na+ = 147 mmol

Cl- = 110 mmol
HCO3− = 37 mmol
AFTER MIXING
1000 ml of the ready-to-use solution contains:
Active substances:
Sodium chloride = 6.136 g
Potassium chloride = 0.1491 g
Sodium hydrogen carbonate = 2.940 g
Calcium Chloride Dihydrate = 0.2205 g
Magnesium Chloride Hexahydrate = 0.1017 g
Glucose Monohydrate (= anhydrous glucose 1.000 g) = 1.100 g
Sodium = 140 mmol

Potassium = 2.0 mmol
Calcium = 1.5 mmol
Magnesium = 0.50 mmol
Chloride = 111 mmol
Hydrogen Carbonate = 35 mmol
Glucose = 5.55 mmol
Pharmacological Group Haemofiltrates
Shelf life 2 years
Storage conditions after mixing of the two compartments (ready-
to-use solution):
Chemical and physical in-use stability of the ready-to-use
solution has been demonstrated for 48 hours at 30 °C. It is not
recommended to store the ready-to-use solution longer than 48 h
including duration of treatment or at a temperature higher than
30°C prior to the inlet of the pump unit.
From a microbiological point of view, once connected to the
haemodialysis, haemofiltration or haemodiafiltration circuit, and
as hydrogen carbonate is present, the product shall be used
immediately.
Demanded Price As per Drug Pricing Policy-2015
Pack size 5000ml: Delivered in a double chamber bag (two-compartment).
Mixing of both solutions by opening the seam between the two
chambers result in the
ready-to –use solution for heamofiltration.
International availability N/A
Me-too status Not verifiable
Detail of certificates attached  Original legalized CoPP
Certificate No: Ba4Q90
Certifying Authority: BFARM, Germany
Free sale in exporting country: Yes
 GMP: The facilities and operations of manufacturing site
conform to GMP as recommended by WHO.
 GMP Certificate
Certificate no. DE_SL_01_GMP _2017_1014 valid upto 05-07-
2020
Manufacturer Address: M/s Fresenius Medical Care
Deutschland GmbH, 66606 St. Wendel / Germany.
Legalized copy of GMP certificate issued by Ministerium for
Soziales, Gesundheit, Frauen und Familie
Sole Agency Agreement: Original legalized Authorisation

certificate issued by M/s Fresenius Medical Care Deutschland
GmbH Else-Kroner- Straße 1 61352 Bad Homburg
v.d.H./Germany declaring “M/s Fresenius Medical Care
Pakistan (Private) Ltd. TAMC, First Floor, 27C III, M.M. Alam
Road Gulberg III, Lahore 54660,Pakistan” as sole agent
responsible for importation, distribution and all registration
related matters for applied formulation.
Remarks of the Evaluator:
Since the applied formulation is packed in a semi permeable plastic container hence firm has
submitted 6 months accelerated (40°C / < 25 % RH) and 24 months long term (30°C / 35 % RH)
stability studies of three batches
Decision: Deferred for confirmation from Medical Devices and Medicated Cosmetics Division,
whether applied formulation falls into classification of Medical devices or not as per prevailing
rules.
1206. Name and address of Applicant M/s Fresenius Medical Care Pakistan (Private) Ltd.
TAMC, First Floor, 27C III, M.M. Alam Road Gulberg III,
Lahore 54660,Pakistan
MA. No: 50736.00.00 dated 19.02.2002

Diary No. & Date of R& I Dy. No. 13004-D Dated 09-04-2018
BEFORE MIXING
Each 1000ml solution contains

(small compartment)
Active substances:
K+ = 80 mmol
Ca2+ = 30 mmol
Mg2+ = 10 mmol
Cl- = 162 mmol
Glucose = 111 mmol

(large compartment)
Active substances:
Na+ = 147 mmol

Cl- = 110 mmol
HCO3− = 37 mmol
AFTER MIXING
Active substances:
Sodium = 140 mmol

Calcium = 1.5 mmol
Chloride = 113 mmol
Glucose = 5.55 mmol
Shelf life 2 years
to-use solution):
immediately.
International availability
 GMP Certificate
2020

rules.
MA. No: 50735.00.00 dated 19.02.2002

Diary No. & Date of R& I Dy. No. 13004-C Dated 09-04-2018
BEFORE MIXING

(small compartment)
Active substances:
K+ = 60 mmol
Ca2+ = 30 mmol
Mg2+ = 10 mmol
Cl- = 142 mmol
Glucose = 111 mmol

(large compartment)
Na+ = 147 mmol

Cl- = 110 mmol
HCO3− = 37 mmol
AFTER MIXING
Active substances:
Sodium = 140 mmol

Calcium = 1.5 mmol
Chloride = 112 mmol
Glucose = 5.55 mmol
Shelf life 2 years
to-use solution):
immediately.
 GMP Certificate
2020
For stability studies firm has referred as under:
“As all solutions of multiBic systems are closely related with only slight differences in their
composition, they fulfil the requirements for applying a reduced stability testing plan with bracketing
and matrixing.
According to ICH guidelines Q1A R2 “Stability Testing of New Drug Substances and Products“
(CPMP/ICH/2736/99) and Q1D “Bracketing and Matrixing Designs for Stability Testing of Drug
Substances and Drug Products“ (CPMP/ICH/4104/00), the stability study design has been set in such
a way that only samples on the extremes regarding strength are tested.
Solutions chosen for stability testing represent the extremes regarding solution strength, as these are
the ones which contain all ingredients in the highest (multiBic 4 mmol / l potassium) resp. the lowest
(multiBic potassium-free) concentrations and multiBic 2 mmol /l potassium which represents the
lowest strength including potassium chloride. Thus, the solutions are representative for the stability
of the intermediate concentration, which is the solution multiBic 3 mmol/l, as well and further testing
on this intermediate concentration is not necessary.”
rules.
MA. No: 50131.00.00 dated 19.02.2002

Diary No. & Date of R& I Dy. No. 13004-A Dated 06-04-2018
Brand Name +Dosage Form + multiBic potassium free solution for
BEFORE MIXING

(small compartment)
Active substances:

th
| 587
Ca2+ = 30mmol
Mg2+ = 10mmol
Cl- = 82mmol
Glucose = 111 mmol

(large compartment)
Active substances:
Na+ = 147 mmol

Cl- = 110 mmol
HCO3− = 37 mmol
AFTER MIXING
Active substances:
Sodium = 140 mmol

Calcium = 1.5 mmol
Chloride = 109 mmol
Glucose = 5.55 mmol
Shelf life 2 years
to-use solution):
immediately.
 GMP Certificate
2020

rules.
Evaluation by PEC: With reference to above cited decision of Registration Board, confirmation was
sought from Medical Devices and Medicated Cosmetics Division, to which Assistant Director-IV
(MDMC) has responded as under vide letter No. F.No.16-4/2018-MD dated 08-01-2019:
In this regard, it is submitted that upon evaluation of the dossier, the above mentioned products shall be
dealt as drugs due to following reasons.
I. The firm have provided Copp (Certificate of Pharmaceutical Products) of the above mentioned
products from Sweden and Germany which is issued only for the Pharmaceutical products and
not for medical devices.
II. The above mentioned products has been registered as drug in different countries live UK,
Sweden, Netherlands, Germany, Belgium, Australia etc. and their Market Authorization numbers
are available.
III. Above mentioned products are categorized as Pharmacotherapeutic group: Hemofiltrates, ATC
code: B05ZB as mentioned in SPC (Summary of Product Characteristics). The Anatomical
Therapeutic Chemical (ATC) Classification System is used for the classification of active
ingredients of drugs according to the organ or system on which they act and their therapeutic,
Pharmacological and chemical properties.
IV. The formulation of the above mentioned products are also available in European Pharmacopoeia.
V. The products are administered directly into the bloodstream (Intravenously). GMDN code is
available for Haemodialysis concentrate and dialysate solution but no GMDN code is found for
solution to be administered intravenously to correct chemical imbalance of the blood caused by
kidney failure.
Evaluator PEC-V
1209. Name and address of Applicant M/s OBS Pakistan (Pvt.) Limited , C-14, Manghopir Road,
S.I.T.E Karachi
Detail of Drug Sale License Address: C-14, Manghopir Road, S.I.T.E Karachi
Validity: 23 May 2018
Status: Drug License by Way of Retailsale
Name and address of manufacturer M/s Santen Pharmaceutical Co. Ltd Shiga Plant
348-3, Aza-suwa, Oaza- shide, Taga-cho, Inukami-gun, Shiga,
Japan
M/s Santen Pharmaceutical Co. Ltd Shiga Plant will be
responsible for
• Preparation of drug solution process.
• Filtration for sterilization and filling process.
• Release testing of product.
and M/s Santen Pharmaceutical Co. Ltd Noto Plant
2-14, Sikinami will be responsible for
• Packaging and labelling process.
• Release testing of product
• Batch release.
Name and address of marketing M/s Santen Pharmaceutical Co. Ltd Shiga Plant
authorization holder 348-3, Aza-suwa, Oaza- shide, Taga-cho, Inukami-gun, Shiga,
Japan
Name of exporting country Japan
Brand Name +Dosage Form + Taflotan Opthalmic Solution 0.0015%w/v
Strength
Tafluprost….15ug
Finished Product Specification Inhouse
Pharmacological Group Glaucoma and Ocular Hypertension
Shelf life 3 years
Demanded Price MRP as per Originator pack
Pack size 1’s 2.5ml polypropylene bottle with polypropylene dropper
International availability Approved in USFDA
Zioptan By Merck Sharp, USA
Me-too status N/A
Detail of certificates attached Original legalized CoPP
Certifying Authority: Ministry of Health, Labour and
Welfare, Government of Japan
Free Sale: Confirms the free sale of the product in exporting
country.
GMP: The facilities and operations conform to WHO-GMP.
GMP certificate
Welfare
Free sale Certificate
Welfare
Issue Date:22-11-2017
Letter of Authorization
Date of Agreement:05-10-2017
Validity :3 Years
Remarks of the Evaluator. Firm provided the stability data at following conditions;
● Long term test: 25C/40%RH & 30/75%RH (36
months)
● Accelerated Test: 40C/NMT 25%RH
The submitted stability data for accelerated condition is not as
per Zone IV A requirement.
Firm submitted the following reply;
The stability testing was conducted in compliance with
Stability testing of New Drug Substances and Products.
The accelerated test conditions has been performed under low
humidity conditions 40C/25%RH instead of climate zone IVA
high humidity condition which is not recommended and
preferred for semi permeable container as stated in ICH.
A Significant change has been observed in assay value of

Tafluprost for all the three batches MTD1332, MTD1333
and MTD1334 at long term stability condition. Clarify.
Upto 36 months storage at 30C/75% the decrease of tafluprost
content is observed (6.5%-6.7%).
The increase of the related substances as degradation product
of tafluprost are observed (1.6%-1.8%), but it is no problem
for safety.
According to the above result , the amount of total
degradation products is less then the decrease of tafluprost
content, it is considered that the reason for the decrease of
tafluprost are not only degradation but also adsorption to
container.
The results of the other tests items are within the
specifications, and there are no significant changes.
The stability is affected by temperature but it is stable for 36
months after distribution under light protected and below
30C..
● Submission of long term stability data according to Zone IVA condition. Submitted data for
long term stability is at 25C/40%RH which is not according to Zone IVA for semi-
permeable containers.
● Submission of test for determination of potential water loss in case of semipermeable
membrane.
Evaluation by PEC:
Firm submitted the following reply:
● Submission of long term stability data according to Zone IVA condition. Submitted data for
long term stability is at 25°C/40%RH which is not according to Zone IVA for semi-
permeable containers.
Please note that the stability conducted on 25°C±2/40%±5 complies the criteria of WHO guidelines
which clearly states the condition in which whether the long term studies are performed at on
25°C±2/40%±5 or 30°C±2/35%±5 is determined by the climatic condition under which the FPP is
intended to be marketed. . Testing at 30 °C/35% RH can be an alternative to the storage condition at
25 °C/40% RH.
Also the region has claimed that incase of semi-permeable container, the low humidity condition
25°C±2/40%RH±5 is a more severe storage condition than high humidity condition 30 °C/35% RH.
Evaluation
However, the data is at 25 °C/40% RH and not at 30 °C/35% RH. Therefore, the stability is
not as per guideline.
Moreover, the low humidity condition is 30 °C/35% RH and not 25°C/40%RH.
The firm has performed stability testing according to ASEAN requirement i.e. at
30°C/75%RH but test for water loss has not been conducted. Moreover, the stability data is of
Shiga Plant whereas, M/s Santen Pharmaceutical Co. Ltd Noto Plant 2-14, Sikinami will be
responsible for
i. Packaging and labelling process.
ii. Release testing of product
iii. Batch release.
1210. Name and address of M/s Hakimsons (Impex) pvt. Limited,
Applicant Hakimsons building, 19-west wharf road, Karachi.
Detail of Drug Sale License Address: Hakimsons building, 19-west wharf road, Karachi.
Validity: 15-Sep-2019
Name and address of M/s Mylan Laboratories Limited
manufacturer Plot No. 1606-1609, G.I.D.C
Sarigam, Dist. Val Sad, Gujrat, India
Name and address of marketing M/s Mylan Laboratories Limited
authorization holder Plot No. 1606-1609, G.I.D.C
Sarigam, Dist. Val Sad, Gujrat, India
Brand Name +Dosage Form + ZINNIA F
Strength
Composition Each sugar coated white tablet contains:
Levonorgestrel………………. 150mcg
Ethinylestradiol…………….... 30mcg
Each sugar coated brown tablet contains:
Ferrous fumarate…………….. 75mcg eq. to Ferrous iron
24.375mg
Pharmacological Group contraceptive
Shelf life 5 years
Demanded Price Decontrolled for UNFP/USAID supplies only
Pack size Combo pack of 21 tablets of Levonorgestrel + Ethinylestradiol
and 7 Tablets of Ferrous fumarate.
3 Blisters of 28 Tablet Each
International availability Ovranette® 150/30 micrograms sugar Coated Tablets.
MHRA Approved
Me-too status
Detail of certificates attached Original legalized CoPP
Certificate No. 051459
Issued by: Food and Drugs Control Administration, Gujarat
state, India
Valid up to: 09/04/2019
Confirms the free sale of the product in exporting country.
The facilities and operations conform to WHO-GMP.
Remarks of the Evaluator. The firm has claimed In House specifications while both tablets
are present in USP and BP.
Following are the short comings:
 Evidence of approval of the product in reference
regulatory authorities since the product is approved in USFDA
in different strength and me too status of the product.
 No combo pack and sugar coated tablet could be
confirmed.
Previous Decision(M-283): Deferred for the following reasons:
Confirmation whether applied formulation can be
imported from India or otherwise as per prevailing Import
Policy Order.
Evidence of approval of applied formulation as combo
pack 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) Along with registration
number, brand name and name of firm as combo pack.
Fresh Evaluation:
Firm has submitted that:
 Confirmation whether applied formulation can be imported from India or otherwise
as per prevailing Import Policy Order.
The applied formulation is estradiol and progesterone (sex hormone) and is not present in
negative list.
 Evidence of approval of applied formulation as combo pack in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th
meeting.
Prequalified by WHO Ethinylestradiol/Levonorgestrel Tablet + Placebo (Ferrous
Fumarate Tablet)
1211. M/s Hoffmann Human Health Pakistan, ltd.
Name and address of Applicant
32-Babar Block, New Garden town,Lahore
Address: 32-Babar Block, New garden town, Lahore.
Detail of Drug Sale License Validity: 29, Nov, 2019
Head Office:
B-1,Extn./A-27, MCIE, Malthura Road, New Dehli
110044, India
Name and address of
Factory:
manufacturer
M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel
Pradesh-173205, India
Form 5-A + Sole
M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel
Name and address of marketing
Pradesh-173
205, India
& Date of R& I Dy. No.17792 Dated 11/10/2017
MYCEPT 250mg Capsule
Strength
Composition
Mycophenolate mofetil…..250mg
Pharmacological Group Immunosuppressant
Demanded Price Rs. 4000/- per box of 30 capsule
Pack size 3x10’s Blister strip.
International availability Cellcept 250mg Capsules
Me-too status N/A
 Original legalized CoPP
(certificate No.MB/05/203/WHO/GMP/18-116) certified
by State Drugs Controller, Licensing Authority cum
Controlling Authority, Himachel Pradesh, India valid till
11/02/2020 confirms the free sale of the product in
Detail of certificates attached
exporting country. The facilities and operation conform to
WHO-GMP. (does not contains the name of Pakistan)
 Free sale certificate (Legalized) confirming free sale of
the applied product is attached.
 Letter of Authorization valid up to 30, April 2020.
Remarks of the Evaluator. Product is present in USP not in BP.
Deferred for confirmation whether applied formulation can
Previous Decision(M-286): be imported from India or otherwise as per prevailing
Import Policy Order.
Fresh Evaluation:
Immunosuppressants are not present in negative list as per prevailing Import Policy Order.
1212. M/s Hoffmann Human Health Pakistan, ltd.
32-Babar Block, New Garden town,Lahore
Address: 32-Babar Block, New garden town, Lahore.
Detail of Drug Sale License Validity: 29, Nov, 2019
Head Office:
B-1,Extn./A-27, MCIE, Malthura Road, New Dehli 110044,
India
Name and address of
Factory:
manufacturer
M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel Pradesh-
173205, India
Form 5-A + Sole
M/s Panacea Biotec Ltd. Malpur, Baddi, Himachel Pradesh-
Name and address of marketing
173
205, India
Brand Name +Dosage Form + MYCEPT 500 tablet
Strength (film coated tablet)
Composition
Mycophenolate mofetil…..500mg
Pharmacological Group Immunosuppressant
Demanded Price Rs. 8000/- per box of 30 capsule
Pack size 3x10’s Blister strip.
International availability Cellcept 500mg Film-Coated Tablets
Me-too status N/A
 Original legalized CoPP
of certificates attached (certificate No. MB/05/203/WHO/GMP/18/117) certified by
State Drugs Controller, Licensing Authority cum Controlling
Authority, Himachel Pradesh, India valid till 11/02/2020
confirms the free sale of the product in exporting country.
The facilities and operation conform to WHO-GMP. (does
not contains the name of Pakistan)
 Free sale certificate (Legalized) confirming free sale of the
applied product is attached.
 Letter of Authorization valid upto 30, April 2020.
Remarks of the Evaluator. Product is present in USP.
Deferred for confirmation whether applied formulation
Previous Decision(M-286): can be imported from India or otherwise as per prevailing
Import Policy Order.
Fresh Evaluation:
Immunosuppressants are not present in negative list as per prevailing Import Policy Order.
1213. M/s Pharmatech Pakistan (PVT) Limited, D-86/A, Mangophir
Road, SITE, Karachi.
Address: Pharmatech Pakistan (Pvt.) Ltd. Pharmatech
Pakistan (Pvt.) Ltd.
Detail of Drug Sale License
Status: Drug sale license by the way of wholesale
M/s Laboratorios Menarini, S.A. C/ Alfonso XII, n0 587
Name and address of manufacturer
08918 Badalona (Barcelona), Spain
Name and address of marketing M/s Menarini International Operations Luxembourg, S.A. 1,
authorization holder Avenue de la Gare Lxembourg L-1611 Luxembourg
KETESSE 25mg Granules for oral solution
Strength
Composition Dexketoprofen trometamol…….. 36.9mg
(Eq. to Dexketoprofen………….. 25mg)
Pharmacological Group NSAIDS
For 4’s pack Rs. 640/-
Demanded Price For 10’s pack Rs. 1600/-
For 20’s pack Rs. 3200/-
Pack size 4’s, 10’s, 20’s
International availability Spain Approved
Me-too status ---
● Original legalized CoPP (certificate No. 2018/00153)
certified by Spanish Agency of Medicines and Medical
Devices, Spain issued on 22/1/2018 confirms the free sale of
the product in exporting country. The facilities and
Detail of certificates attached operations conform to WHO-GMP.
● Agreement/Authorization Issued by
M/s Menarini Asia Pacific Holdings 30 PasirPangjang Road
8-32, Maple Tree Business City Singapore
● The firm has claimed In House specifications and the product is not present in USP/BP.
● Sole agency agreement/letter of authorization.
● Clarification is required since significant changes (more than 5%) have been observed in assay
value of stability studies between initial and final time points.
Clarification of significant changes in assay, value of stability studies from principal A. Menarini is
as under :
a. The observed decrease in the assay values between initial and final time points of the provided
stability data cannot be considered a critical issue since this trend doesn’t affect the requested
quality profile of the drug .
b. More in detail, as reported in the submitted section 3.2.P.8 (Dossier Vol- 2, Annexure XXI”, the
stability of the drug product has been verified for the entire shelf life at 30°C/ 75% RH, 30°C/65%
RH & 30°C/60% RH long term conditions, and the obtained results are fully accompanied with the
shelf life specifications proving that the observed decrease in the assay value does not significantly
affect the quality profile of the finished medicinal product. Taking into account all the above
mentioned considerations, the applicant deems that the observed decrease in the assay value during
storage does not represent a critical aspect, thus excluding any risk of the quality and the efficacy of
the finished medicinal product as well as for the safety of the patients.
Description of the product:
The drug is indicated for symtomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain, dysmonerrhoea, dental pain.
Decision(M-282):
Deferred for following reasons:
● Justification of clarification regarding significant changes in assay values at long term
stability condition.
● Evidence of relationship between product license holder “M/s Menarini International
Operations Luxembourg, S.A. 1, Avenue de la Gare Lxembourg L-1611 Luxembourg and
“M/s Menarini Asia Pacific Holdings,30 Pasir Pangjang Road,8-32, Maple Tree Business City
Singapore”.Provide agreement /Authority Letter from product license holder.
Fresh Evaluation:
Firm has submitted the following reply:
 Justification of clarification regarding significant changes in assay values at long term
stability condition.
We, Laboratorios Menarini, S.A., located in Alfonso XII, 587, 08918 Badalona, Spain,
proposed finished product manufacturer of dexketoprofen trometamol 25 mg granules for oral
solution, hereby
DECLARE
that the observed decrease in the assay values between initial and final time points of the provided
stability data have not be considered as a critical issue since this trend doesn't negatively affect the
requested quality profile of the drug product as defined by the shelf-life specifications reported in
the submitted section 3.2.P.5.1, for the entire proposed shelf life.
More in detail, as reported in the submitted section 3.2.P.8, the stability profile of the drug
product has been verified for the entire shelf life at 30 °C/75% RH, 30 °C/65% RH and 25 °C/60%
RH long term conditions. In addition, notwithstanding the observed decrease in the assay value, we
would like to point out that the lower specification limit of assay at the end of shelf life has been
settled to 92%, according of the results of the first ICH stability studies performed on the product,
thus allowing a loss in the assay more than 5% which may occur during storage if the whole shelf-
life span is considered. Thus it should be noted that, seeing the significant change observed in the
assay value during the studies under accelerated conditions, also intermediate and long term
conditions, both for climatic zone II and IV, have been investigated, confirming that the
decrease of the assay happens gradually throughout the shelf-life and corresponds to an increase of
the impurities content, proving that the phenomenon is properly controlled and falls into the natural
degradation of the active ingredient. Furthermore, the concerned stability studies demonstrate
that the quality profile of the medicinal product is maintained, being all the results in
compliance with the shelf-life specifications thus confirming that the observed decrease in
the assay value does not affect the quality profile of the finished medicinal product.
Taking all the above mentioned consideration into account, we deem that the observed decrease in
the assay value during storage does not represent a critical aspect, thus excluding any risk for the
quality and efficacy of the finished medicinal product, as well as for the safety of the patients.
 Evidence of relationship between product license holder “M/s Menarini International
Operations Luxembourg, S.A. 1, Avenue de la Gare Luxembourg L-1611 Luxembourg
and “M/s Menarini Asia Pacific Holdings,30 Pasir Pangjang Road,8-32, Maple Tree
Business City Singapore”.Provide agreement /Authority Letter from product license
holder.
Firm has submitted letter of declaration concerning the transfer of ownership of the rights on the
product Ketesse Granules for Oral Solution.
We, MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., a company existing
under the law of Luxembourg, with registered officers at 1, Avenue de la Gare, L-1611
Luxembourg, and LABORATORIOS MENARINI SA, a company existing under the law of Spain,
with registered offices at ownership of all rights relating to the product Ketesse Granules for oral
solution 25mg/ Sachet with respect to the country of Pakistan, to A. MENARIINI ASIA-PACIFIC
HOLDINGS PTE. LTD., a company incorporated in Singapore and with registered offices located
at 30 pasir Panjang Road, #08-32 Mapletree Business City, Singapore 117110.
Evaluator PEC-XII
1214. M/s. Revive Health Form 5A
Colicraft 1,000,000 IU Colomycin COPP 260th
Care, Lypholized Dy No.619
powder Injection 1 was Meeting
Office No.503, 5th for solution R&I dated
for Million issued by Registration
Floor, 6 Main Injection 31-12-2015 Internation Spain on Board held
Gulberg, Jail Road, Rs.50,000/- al Units. dated 04- on 28-29th
Lahore. Each vial contains:- As per powder for 05-2016. June, 2016
Colistimethate Sodium PRC. soln for inj Deferred for
M/s. GENFARMA …2,000,000 I.U infusion by GMP confirmation
LABORATORIO, M/s Forest compliant whether
S.L. Site address (Antibiotic)/Polymyxin Laboratori as per formulation
Avda. De la es, UK COPP is me too or
Constitucion, 198- MHRA dated 04- otherwise
199, Poligono USP Specifications approved 05-2016.
Industrial Monte 03 years
Boyal, Casarrubios del
Monte 45950 (Toledo)
Espana, Spain.
Evaluation by PEC
 The applied product is approved/registered by the board for sale in Pakistan. i.e.
Colistat Injection 1MIU (vial) by M/s Medisure Laboratories, Karachi (Reg#076160)
 Firm has also submitted differential fee of Rs. 50,000/- (Challan#0824422) Dated 16-01-2019
Decision:
1215. Name and address of Applicant M/s Himmel Pharmaceuticals (Pvt) Ltd,
House#793-D, Block-C, Faisal Town, Lahore.
Detail of Drug Sale License Address: House#793-D, Block-C, Faisal Town, Lahore.
License no.: 05-352-0065-016174D
Status: License to sell drugs as a Distributor.
Name and address of manufacturer Product license holder: M/s Mylan Pharmaceuticals, S.L.
Plom 2-4, 5 Planta, 08038, Barcelona, Espana/ Spain.
Manufacturing site: M/s PRASFARMA, S.L,
C/Sant Joan, 11-15, 08560, Manlleu (Barcelona), Espana/ Spain.
Name and address of marketing M/s Mylan Pharmaceuticals, S.L.
authorization holder Plom 2-4, 5 Planta, 08038, Barcelona, Espana/ Spain
Brand Name +Dosage Form + HimTam 20mg Tablets
Strength
Tamoxifen (as citrate) …20mg
Finished Product Specification In-house specifications
Pharmacological Group Hormone antagonists and related agents (Anti-estrogens)
Shelf life 2 Years
Pack size Type I glass vials containing 15ml concentrated solution in pack
size of 1’s
International availability TAMOXIFENO FUNK 20 mg Comprimidos by M/s Spain
(CIMA Spain Approved)
Me-too status Bilem Tablets 20mg by M/s Getz Pharma (Reg#036690)
Detail of certificates attached ● Original legalized CoPP issued on 05-10-2017 by Agencia
Espanola Del Medicamento Y Productos Sanitarios confirms
free sale of the product.
● Original legalized GMP certificate of the manufacturer is
submitted which is valid until 16th June 2020. Certificate #
NCF/1739/001/CAT. The certificate is issued by Ministry of
Health of Government of Catalonia- Spain.
● Original, legalized and valid Sole agency agreement by M/s
PRASFARMA, S.L, C/Sant Joan, 11-15, 08560, Manlleu
(Barcelona), Espana/ Spain., issued on 16-11-2017 and valid
for 3 years is submitted by the firm.
 The product is registered in Spain by M/s Mylan under name: TAMOXIFENO FUNK 20 mg
Comprimidos (Marketing authorisation number: 58110)
 The Sole agency agreement/ contract is issued in the name of manufacturer i.e. M/s PRASFARMA,
S.L, who is not product license holder of the product.
 Firm has claimed in-house specifications whereas the product monograph is available in BP.
 The difference in BP and in-house specifications is as follows:
Tests BP specifications In-house specifications
Assay limits 90-110% 95-105%
 Firm has submitted 6 months accelerated stability study data and 36 months real-time stability study
data of 3 batches of batch A-20, A-21 and H-7 manufactured in January 2016,(as per Zone IV-A)
Initiation dates:
Batch # A-20 (October 2007)
Batch # A-21(October 2007)
Batch # H-7(October 2014)
Decision of previous meeting of RB Deferred for submission of legalized and valid sole agency
agreement between the applicant and product licence holder i.e
M/s Mylan Pharmaceuticals, S.L. Plot 2-4, 5 Planta, 08038,
Barcelona, Espana/ Spain. (M-286)
Evaluation by PEC:
Firm has submitted Explanation letter issued by M/s Mylan Pharmaceuticals, S.L. Plom 2-4, 5 Planta,
08038, Barcelona, Espana/ Spain (Product licence holder) stating that:
“M/s Mylan Pharmaceuticals, S.L as holder of registered product in Spain TAMOXIFENO FUNK 20 mg
Comprimidos , has authorized PRASFARMA, S.L, to apply for COPP, in order to register this product in
Pkistan by by Himmel Pharmaceuticals (Pvt) Ltd. PRASFARMA, S.L is manufacturer of product.
Both companies PRASFARMA, S.L, and Mylan Pharmaceuticals, S.L. have a business relation regarding
registration of products outside Europe and we have no objection on this registration of Tamoxifen
(HimTam) by Himmel Pharmaceuticals (Pvt) Ltd.”
Decision:
1216. Name and address of Applicant M/s AGP (Private) Limited,
B-23, S.I.T.E, Karachi
Name and address of manufacturer M/s Mylan Laboratories Limited, Plot No. 11, 12 & 13 Indore
Special Economic Zone, Pharma Zone, Phase-II, Sector_III,
Pithampur-454775, Dist,-Dhar (Madhya.Pradesh.) India
Name and address of marketing M/s Mylan Laboratories Limited, Plot No. 11, 12 & 13 Indore
authorization holder Special Economic Zone, Pharma Zone, Phase-II, Sector_III,
Pithampur-454775, Dist,-Dhar (Madhya.Pradesh.) India
Corporate Office:
House No8-2-293/82/J-III, Plot No. 564/A/22, Road No. 92, Jubilee
Hills, Hyderabad-500 033, India
Brand Name +Dosage Form + TREZAV
Strength (Immediate Release, Film Coated Tablet)
Lamivudine……. 150mg
Nevirapine………200mg
Zidovudine……...300mg
Pharmacological Group Anti-Retroviral
Demanded Price 2634.05/- per bottle of 60 tablets
Pack size 60 Tablets in HDPE bottle
International availability LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE by Cipla Limited,
Tentative Approval by USFDA
Tentative Approval:
If a generic drug product is ready for approval before the expiration
of any patents or exclusivities accorded to the reference listed drug
product, FDA issues a tentative approval letter to the applicant. The
tentative approval letter details the circumstances associated with the
tentative approval. FDA delays final approval of the generic drug
product until all patent or exclusivity issues have been resolved. A
tentative approval does
Me-too status Zidolam-N tablets. by A‟raf Pharmaceuticals (Imported)
(Reg#041106)
Detail of certificates attached Legalized and Valid CoPP (certificate No. 7/2014) issued by Food
and Drug Administration, Bhopal, Madhya Pradesh, India valid till
26/09/2018 confirms the free sale of the product in exporting country.
The facilities and operations conform to GMP as recommended by
WHO as per CoPP.
Remarks of the Evaluator.  The firm has claimed In House manufacturing specifications and
the product is not present in pharmacopoeia (USP & BP).
 Firm has stated that initially the product was manufactured at
Mylan Laboratories, Nashik site due to commercial reasons the
product has been transferred to Mylan Laboratories Indore.
Provided stability data from Nashik site is of 5 years but stability
data from new site that is Indore, is of only 2 years which does
not support the shelf life.
Decision of previous meeting of Registration Board deferred the case for the following reasons:
RB  Submission of long-term stability data till shelf life of the
product.
 Clarification whether anti-viral drugs can be imported from India
or otherwise.
 Evidence of approval in reference regulatory authorities.
(M-271).
Evaluation by PEC
 The applied product is approved/registered by the board for sale in Pakistan. i.e.
Zidolam-N tablets. by A‟raf Pharmaceuticals (Imported) (Reg#041106)
Firm has submitted differential fee of Rs. 50,000/- (Challan#0789324) Dated 21-01-2019
 This formulation is also WHO prequalified.
Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg by Mylan Laboratories
Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India (WHO
Reference Number: HA426 *)
 Firm has submitted that the product is not included in the SRO No. 280 (I) /2012 ‘List of items not
imported from India’ therefore the product can be imported.
 Firm has submitted 6 months accelerated stability study data and 48 months real-time stability study
data of 3 batches of batch 3027703, 3028149 and 3028150 conducted by the manufacturer i.e: Mylan
Laboratories Limited, Plot No. 11, 12 & 13 Indore Special Economic Zone, Pharma Zone, Phase-II,
Sector_III, Pithampur-454775, Dist,-Dhar (Madhya.Pradesh.) India.
Accelerated stability conditions: 40℃ ±2 ℃, 75%RH±5%RH

Long-term stability conditions: 30℃ ±2 ℃, 75%RH±5%RH
Batch# Mfg date Initiation date

3027703 June 2014 12-09-2014
3028149 June 2014 12-09-2014
3028150 July 2014 12-09-2014
Decision:
Evaluator PEC-XIV
1217. Name and address of Applicant M/s Himmel Pharmaceuticals Pvt Ltd.
793-D, Block “C” Faisal Town Lahore, Pakistan
Detail of Drug Sale License Adress: M/s Himmel Pharmaceuticals, 793D, Block C,
Faisal Town, District Lahore.
Status: License to sell drugs as a Distributor.
Name and address of the manufacturer M/s BEACON Pharmaceuticals Limited, kathali,
Bhaluka, Mymensingh, Bangladesh
Head office:
BEACON Business Centre, 9/A, Toyenbee Circular
Road, Motijheel Dhaka, Bangladesh
Name and address of marketing M/s BEACON Pharmaceuticals Limited, kathali,
authorization holder Bhaluka, Mymensingh, Bangladesh
Office Address: 9/A, Toyenbee Circular Road, Motijheel
Dhaka, Bangladesh
Name of exporting country Bangladesh
Diary No. & Date of R& I 27959, 16-08-2018
Fee including differential fee 50,000/-, 11-08-2018
Brand Name +Dosage Form + Strength Regonix 40 Tablet
Regorafenib Monohydrate…..41.491mg eq. to 40mg
Regorafenib
Finished Product Specification In-house specifications
Pharmacological Group Anti-Cancer; Protein Kinase inhibitor
Demanded Price Not mentioned
Pack size 1 × 28’s in HDPE bottle
International availability STIVARGA 40mg Tablet of Bayer Hlthcare (USFDA
approved)
Me-too status N/A
Detail of certificates attached ● Original legalized CoPP issued on 28-02-2018 by
Directorate General of Drug Administration, Aushad
Bhaban, Mohakhali, Dhaka-1212, Bangladesh confirms
free sale of the product in the exporting country.
Certificate No: DA/ 6-110/2016/4366.
● Original legalized GMP certificate of the manufacturer
is submitted which is issued on 20-07-2017. Certificate
No: DA/ 6-110/06/10002.
● Original , legalized letter dated 03-03-2018 from M/s
Beacon Pharmaceuticals Limited., Kathali, Bhaluka,
Mymensingh, Bangladesh declaring M/s Himmel
Pharmaceuticals Pvt Ltd. 793-D Block ‘C’, Faisal
Town, Lahore, Pakistan as authorized agent to register
and sell the applied product in the territory of Pakistan.
Remarks of the Evaluator.  Firm has submitted 6 months accelerated (40 oC ±2 oC,
75%RH±5%RH) stability study data and 24 months
real-time (30 oC ±2 oC, 65%RH±5%RH) stability study
data of 3 batches.
 Manufacturing dates:
Batch #3100007 (05-2016)
Batch #3100008 (05-2016)
Batch #3100009 (05-2016)
Dissolution method mentioned in Finished product
specifications is not as per recommendation of FDA.
Clarification is required.
Previous Decision Deferred for following: (M-286)
Clarification/ revision of label claim on Form-5A as per
CoPP.
Clarification since the submitted dissolution test method
is not in accordance with USFDA recommendation.
Deferred for further deliberation upon justification of
using dissolution method other than that recommended by
USFDA for innovator’s product (M-287).
Evaluation by PEC The firm has submitted revised Form-5A with correct
label claim and fee challan of Rs. 5000/- (deposit slip #
0762366) dated 14-12-2018.
Dissolution method
In-house dissolution USFDA Recommended
conditions
Apparatus: USP Type II Apparatus: USP Type II
(paddle) (paddle)
Dissolution medium: Dissolution medium:
0.1M HCl with 2% SLS Acetate Buffer pH 4.5
Revolution: 100 RPM with 0.1% Sodium
Dissolution time: 45 min Dodecyl Sulfate (SDS)
Revolution: 75 RPM
Dissolution time: 45 min
The firm has submitted justifcation regarding dissolution

method that Regorafenib tablet is a non-pharmacopoeial
product and we use in-house developed method based on
BRITISH Pharmacopeia: Recommendations on
Dissolution Testing.
The pH of the dissolution medium is usually set between
pH 1 and pH 8. In justified case higher pH may be
needed. For the lower pH values in the acidic range, 0.1M
hydrochloric acid is normally used.
Using the paddle or basket apparatus, the volume of
dissolution medium is normally 500-1000ml. A stirring
speed of 50 rpm and 100 rpm is normally chosen; it must
not exceed 150 rpm.
The firm has submitted that Regorafenib is non-
pharmacopeial product and we will adopt FDA
recommended dissolution method in future.
Decision:
iii. Veterinary
Evaluator PEC-XIV
1218. Name and address of Applicant M/s. Huzaifa International, Commercial Area, Aziz Bhatti
Town, Sargodha, Pakistan
Detail of Drug Sale License Valid upto 2019.
Name and address of the manufacturer M/s. Kombipharm International Co. Ltd., 17, Gyeongje-
Ro, Siheung-SI, Gyeonggi-DO, South Korea, The
Republic of Korea
Name and address of marketing M/s. Kombipharm International Co. Ltd., 17, Gyeongje-
authorization holder Ro, Siheung-SI, Gyeonggi-DO, South Korea, The
Republic of Korea
Name of exporting country Korea
Diary No. & Date of R& I Dy No. 722, 25-09-2014
Fee including differential fee Rs.100,000/- 25-09-2014
Brand Name +Dosage Form + Strength Komi Pink Spray
Composition Each Liter contains:-
Florfenicol………………20g
Cetrimide………………..10g
Dimethyl Phthalate……...10g
Crystal violet……………..q.s.
N-Methylpyrrolidone…….q.s.
PVP (Povidone)………….q.s.
Isopropanol………………q.s.
Pharmacological Group Antibiotic-Peptidyl transferase inhibitor
Shelf life 36 months (supported by realtime and accelerated
stability study data)
Pack size 50ml, 100ml, 250ml, 500ml
International availability Available in in korea as per CoPP
Detail of certificates attached 1. Original legalized free sale certificate issued by Animal
and Plant Quarantine Agency Korea on 09-06-2014
confirms free sale availability in Korea
2. Original legalized GMP certificate issued by Animal
and Plant Quarantine Agency Korea on 09-06-2014
confirms GMP status of manufacturing site
Remarks of the Evaluator. 1. Firm has claimed in house spec’s and the product is not
present in BP and USP
Letter of shortcoming was issued to the firm on 14th April
2015 and the reply received is still deficient for
“The drug sale license is to sell drugs in pharmacy and
not for distribution”
Previous Decisions Decision of 270th meeting:
In 270th meeting Registration Board deferred the case as
the concerned member of Board (veterinary expert) was
not available.
Deferred for evidence of approval in reference regulatory
authorities (M-272).
Evaluation by PEC The firm has submitted two references as evidence of
international approval of the product.
1. TOPAZONE NF SRAY, Mexico
The reference cannot be verified; Moreover, Mexico is
not our reference country.
2. FLOXY-SPRAY, Ukraine
The reference has been verified while the firm is unable to
provide evidence of approval in 02 more countries of E.U.
Moreover the product which is registered in Ukraine has a
strength of 2.5gm/100ml while the applied product has
strength of 2gm/100ml.
The firm has submitted reference of formulation approved
in USFDA the composition of which as follows:
Claro Solution
Florfenicol………………16.6mg/ml
Terbinafine as hydrochloride……………14.8mg/ml
Mometasone furoate…………………2.2mg/ml
Our product Komipink Spray is a similar topical
formulation with Florfenicol as an active ingredient and
used for treatment of bacterial infection, scabies and
wounds.
The samples of Komipink spray have been utilized and
appreciated by Pakistan Army and they have demanded
this product availability as soon as possible, since the
Pakistan Army accommodates a great number of Horses,
Dogs and Mules for different defense purposes.
Decision:
Case No. 08: Registration applications of drugs for which stability study data is submitted
a. New cases
b. Deferred cases
Evaluator PEC-XIV
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No of Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision /
Applicant Dosage Form + Date, Fee Local Remarks
Strength), (including Availability (if any)
Composition, differential fee),
Pharmacological Demanded Price GMP
Group, / Pack size Inspection
Finished Product Report Date &
Specification Remarks
1219. M/s Seraph Neovel Tablets Form-5D Renvela 800mg
Pharmaceutical, plot 800mg Diary No. 1647 Tablet of Sanofi
# 210, Industrial dated 11-01-2018, Aventis,
Triangle, Kahuta Each film coated Rs. 50,000/- dated (USFDA
Road, Islamabad tablet contains: 10-01-2018, approved)
Sevelamer 30’s;
Carbonate……..…… As recommended
800mg by PRC The panel
inspection dated
Phosphate binder 11-06-2018
unanimously
Innovator’s recommended
specifications issuance of
GMP
Certificate.

Drug Neovel Tablets 800mg
Name of Manufacturer M/s Seraph Pharmaceutical, plot # 210, Industrial Triangle, Kahuta Road,
Islamabad
Manufacturer of API M/s Suleshvari Pharma, Ankleshwar-393002, Gujarat, india
API Lot No. 17/SVMC/029
Description of Pack Alu/Alu Blister in 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: 26 (Weeks)
Real Time: 26 (Weeks
Frequency Accelerated: 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 26 (Weeks)
Real Time: 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 26 (Weeks)
Batch No. T001 T002 T003
Batch Size 800 Tablets 800 Tablets 800 Tablets
Manufacturing Date 03-18 03-18 03-18
No. of Batches 3
Date of Submission 31-10-2018 (Dy. No. 36103)
Sr. Documents To Be Provided Status
1. COA of API Copy of COA from M/s Suleshvari Pharma, India has
been submitted.
2. Approval of API by regulatory authority of The firm has submitted copy of GMP certificate of M/s
country of origin or GMP certificate of API Suleshvari Pharma, India (Certificate No. S-
manufacturer issued by regulatory authority GMP/17021394) issued by Food & Drug Control
of country of origin. Administration, Ghandhinagar, Gujarat State, India.
3. Protocols followed for conduction of Yes
stability 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. The firm has submitted copy of commercial invoice
(Invoice#SP/EXP-55/2017-18) for the import of
Sevelamer Carbonate (3.00Kg) attested by ADC
DRAP, Islamabad dated 08-03-2018.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
authenticity of 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.
● The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 Batches.
Report on investigation of genuineness / authenticity of data submitted for registration of NEOVEL
Tablet 800mg (Sevelamer Carbonate 800mg) by M/s Seraph Pharmaceutical, Islamabad.
Reference No: F.13-11/2017-PEC (Pt) dated 14th December, 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.
Composition of Panel:
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
Scope of investigation:
Investigation to confirm genuineness / authenticity of stability data and associated documents, import
of API, quality, specification, test analysis, facilities etc.
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:
Detail of Investigation:
Q. No. Question Observation by Panel
1. Do you have documents confirming the Firm have copy of AD (I&E, Islamabad) attested
import API including approval from commercial invoice for import of 3kg Sevelamer
DRAP? Carbonate, Batch No. 17/SVMC/029.
2. What was the rationale behind selecting Firm informed that they have selected API’s supplier on
the particular manufacturer of API? the basis of GMP Certification, Vendor Prequalification
(Desktop) and keeping in view the price advantage.
3. Do you have documents confirming the Phosphate binding capacity is evaluated using Potassium
import of API reference standard and Phosphate which is purchased locally.
impurity standards? No impurities / degradation products have been found.
4. Do you have certificate of Analysis of Firm have Certificate of Analysis of the API (Batch No.
the API, reference standards and 17/SVMC/029).
impurity standards?
5. Do you have GMP certificate of API Firm have copy of GMP certificate No. S-GMP 17021394
manufacturer issued by regulatory of M/s Suleshvari Pharma, India issued by Food and Drug
authority of country of origin? Control Administration, Gujrat, India.
6. Do you use API manufacturer method of Firm have used API manufacturer method of testing for
testing for testing API? testing API (Sevelamer Carbonate).
7. Do you have stability studies reports on Firm have shown copy of 12 Months (Accelerated) and 48
API? Months (Real Time) Stability Study Reports on 03
Batches of API (Sevelamer Carbonate) conducted by the
API Manufacturer (M/s Suleshvari Pharma, India).
8. If yes, whether the stability testing has Firm claims that no impurities / degradation products are
been performed as per SIM method and present hence impurity profiling was not performed.
degradation products have been
quantified?
9. Do you have method for quantifying the Firm claims that no impurities / degradation products are
impurities in the API? present hence impurity profiling was not performed.
10. Do you have some remaining quantities Firm have 0.953 gm of the API (Sevelamer Carbonate)
of the API, its reference standard and remaining.
impurities standards?
11. Have you used pharmaceutical grade Firm have used pharmaceutical grade excipients:
excipients?  Hydrogenated Vegetable Oil
 Microcrystalline Cellulose
12. Do you have documents confirming the Firm have shown documents confirming the import of the
import of the used excipients? used excipients.
13. Do you have test reports and other Firm have test reports and other records on the excipients
records 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 Various combinations of Drug–excipient mixture were
compatibility studies? prepared and analyzed by keeping at accelerated
conditions by the firm. The results were found
satisfactory.
16. Have you performed comparative Firm have performed comparative studies (Disintegration
dissolution studies? and Swelling Test) of their product with SELCARB
Tablet 800mg of M.s Genome Pharma. Details are as
follows:
Details Test Reference

Product Product
Brand NEOVEL SELCARB
Batch No. T001 001
Mfg. Date 3/2018 5/2018
Test product showed comparable results with the

reference product.
17. Do you have product development Firm have product development (R&D) section.
(R&D) section?
18. Do you have necessary equipment Firm have necessary equipment available in product
available in product development section development section for development of applied product.
for development of applied product? However compression was done in Production area using
ZP-17 compression machine.
19. Are the equipment in product The equipment in product development section were
development section qualified? qualified.
20. Do you have proper maintenance / Firm have proper maintenance / calibration / re-
calibration / re-qualification program for qualification program for the equipment used in PD
the equipment used in PD section? section.
21. Do you have qualified staff in product RND Manager (Pharmacist, 08 years exp.) is involved in
development section with proper Product Development (RND).
knowledge and training in product
development?
22. Have you manufactured three stability Three (03) stability batches have been manufactured in
batches for the stability studies of 03-2018 for the stability studies of applied product having
applied product as required? batch size of 800 tablets each.
23. Do you have any criteria for fixing the Keeping in view the DRAP’s criteria, guidelines and no.
batch size of stability batches? of 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 Firm have shown record of production of stability batches.
production of stability batches?
25. Do you have protocols for stability Firm have detailed protocols for stability testing of
testing of stability batches? stability batches.
26. Do you have developed and validated the Firm have developed and validated the method for testing
method for testing of stability batches? of stability batches.
27. Do you have method transfer studies in Not applicable.
case when the method of testing being
used by your firm is given by any other
lab?
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.
and the finished drug?
29. Is your method of analysis stability No impurities / degradation products have been found.
indicating?
30. Is your HPLC software 21CFR No.
Compliant? 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
stability study testing? (Schimadzu, BIOSPEC) was checked and submitted
documents were cross verified.
32. Do you have some remaining quantities No degradation products.
of degradation products and stability Stability batches are kept on Real Time Stability Testing.
batches?
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 Firm have valid calibration status for the equipment used
the equipment used in production and in production and analysis.
analysis?
35. Do proper and continuous monitoring Adequate monitoring and control are available for stability
and control are available for stability chambers (China Chong Qing Chuang, CSH-2225D-C)
chamber? with built-in Digital Data Loggers.
Power backup has been ensured with UPS & 150kV
Generator.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are as per cGMP compliance.
rated as GMP compliant?
CONCLUSION:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of NEOVEL Tablet 800mg (Sevelamer Carbonate 800mg) is verifiable to satisfactory level.
Decision: Deferred for following: (M-287)
Justification of applying UV Spectrophotometric method for Assay analysis of applied formulation instead of
HPLC method.
In vitro bio equivalence equilibrium binding studies and Equilibrium kinetic studies for the applied product.
Evaluation by PEC: The firm has submitted that
“As the vendor of raw material of sevelamer carbonate “Suleshvari, India” is using the UV method for the
analysis of sevelamer carbonate, so we also used the vendor’s UV method for analysis of raw material and
product. Moreover, we validated the testing method, which showed that the UV method is suitable for
analysis of product.
In-vitro kinetic binding study and equilibrium binding study of the drug product was performed as per FDA
guidelines and results were compared with the competitor’s brand “Selcarb 800mg Tablet”.
The firm has submitted details of validation of analytical method.
c. Onsite Verification of stability study data

Evaluator PEC-II
Sr. Name & Address of Brand Name Type of Form, International Availability /
No. Manufacturer / (Proprietary Name + Initial Diary & Local Availability
Applicant Dosage Form + Date, Fee
Strength), (including GMP Inspection Report
Composition, differential fee), Date & Remarks
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
1220. M/s PharmEvo Pvt Teragis 100mg tablet Form 5-D Zafatek Tablets approved by
Ltd, A-29, North West Each film coated tablet Diary No. 438 dated PMDA of Japan
Industrial Zone, Light contains:- 28-03-2016
Industrial Zone, Port Trelagliptin……100mg Rs. 50,000/-
Qasim, Karachi. (Anti-diabetic) 14’s,
As per PRC
Evaluation by PEC:
The firm has submitted stability data along with documents as per checklist approved in 278th meeting
of 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.# 2700 (PEC) dated 17-09-2018)
Drug Teragis 100mg tablet
Name of Manufacturer M/s PharmEvo Pvt Ltd, A-29, North West Industrial Zone, Light Industrial
Zone, Port Qasim, Karachi.
Manufacturer of API Trelagliptin: M/s Ruyuan HEC Pharm, Guangdong province, China
API Lot No. TGLT-201704002
Description of Pack
Alu –Alu foil in unit carton
Frequency Accelerated: 0,3,6 month
Real Time: 0,3,6 month
Batch No. 18PD-2202-02-T 18PD-2203-03-T 18PD-2204-04-T
Batch Size 2500 tablets 1000 tablets 1000 tablets
No. of Batches 03
No.
1. COAS of API
Yes.
2. Approval of API by regulatory authority of country Copy of GMP certificate issued by issued by
of origin or GMP certificate of API manufacturer State office for Health and Social Affairs Berlin,
issued by regulatory authority of country of origin. valid upto 19-05-2019, in the name of M/s
Ruyuan HEC Pharm Co., Ltd., Xiaba
Development Zone, 512721 Shaoguan City,
Ruyuan County, Guangdong Province, China.
The said certificate has been verified form
following web-link of Eudra GMP as accessed
on 21-12-2018:
http://eudragmdp.ema.europa.eu/inspections/gm
pc/searchGMPCompliance.do?ctrl=searchGMP
CResultControlList&action=Drilldown&param=
35719
Moreover Firm has submitted a declaration from
M/s Ruyuan HEC Pharm Co., Ltd stating as
under:
“We have submitted the application to
Guangdong Province FDA for GMP inspection.
Once the inspection is approved, we will provide
the revised provincial GMP immediately.”
3. Protocols followed for conduction of stability study
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, Yes
laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Copy of ADC attested invoice has been
submitted.
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
Yes
till assigned shelf life of the product.
8. Commitment to follow Drug Specification Rules,
Yes
1978.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Teragis
(Trelagliptin) 100mg Tablets by M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial Zone,
Port Qasim , Karachi.
Reference No: F.13-11/2017-PEC (Pt) dated 26th December, 2018.
Investigation Date and Time: 7th February, 2019. (Afternoon)
Investigation Site: Factory premises of M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial
Zone, Port Qasim , Karachi.
Background:
Chairman Registration Board considered the applications of M/s PharmEvo (Pvt.) Limited, A-29, North
Western Industrial Zone, Port Qasim , Karachi for registration of Teragis (Trelagliptin) 100mg & 5mg
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, Department of Pharmacology, University of Karachi.
(Member Registration Board)
2. Dr. Asfandyar Ajab Khan, Assistant Director, CDL, DRAP, Karachi.
3. Dr. Affan Ali Qureshi, 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.
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:
Teragis (Trelagliptin) Tablets 100mg
Q. Question Observation by panel

No.
1. Do you have documents confirming the of The firm has i mpor t ed Trelagliptin 1.5Kg vi de
Trelagliptin API including approval from In voi ce No. WIS1700 27 dat ed 19/ 04/ 2017
DRAP? f r om M /S WIS Pharmtech Co. Ltd. Manufactured
by M/s Ruyuan HEC Pharm Co. Ltd. for the
manufacturing of lab scale batches of TERAGIS
100mg Tablets. The firm has proper approval for
the import of the API from DRAP, Karachi.
2. What was the rationale behind selecting The rationale behind selecting the particular source
the particular manufacturer of API? of API is the laid down criteria of the firm in their
Vendor Evaluation procedure which include the
GMP status of the firm, DMF source and capability
to provide API reference standard and impurity
standard.
3. Do you have documents confirming the Firm has documents confirming the import of
import of Trelagliptin, reference standard Trelagliptin, The APIs working standard was
and impurity standards? imported at the time of import of the APIs
whereas the manufacturer has provided the both
impurity standards later free of cost.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API,
API, reference standards and impurity Working standards of the API and impurities
standards? standards.
5. Do you have GMP certificate of API Firm has GMP certificate issued by the Shaoguan
Manufacturer issued by regulatory Food and Drug Administration, China
Authority of country of origin?
6. Do you use API manufacturer method of The firm has u s e d API manufacturer method for
testing for testing API? testing the API.
7. Do you have stability studies reports on The firm has stability studies reports on API.
API?
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 and however no degradation products are
degradation products have been quantified? reported by the manufacturer. However process
related impurities have been quantified during
9. Do you have method for quantifying the The firm
stability has API manufacturer method for
studies.
impurities in the API? quantifying the impurities in the API.
10. Do you have some remaining quantities of the Firm has some quantities of the API and working
API, its reference standard and standard, however they have consumed all the
impurities standards? impurity standards.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? and include microcrystalline cellulose PH.101,
Mannitol, Hydroxypropyl Cellulose, Cross
Carmellose Sodium, Sodium Stearyl Fumerate
and Opadry white and iron oxide red has been
used for coating.
12. Do you have documents confirming the The firm has necessary documents confirming the
import of the used excipients? import of the used excipients.
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 The firm has written and authorized protocols for
protocols for the development of TERAGIS the development of T E R A G I S 1 0 0 m g
100mg Tablets? Tablets.
15. Have you performed Drug-excipient The firm has not performed Drug-excipient
compatibility studies? compatibility studies as the composition of their
tablets is similar to that of the innovator product
(Zafatek Tablets).
16. Have you performed comparative The firm has not performed comparative dissolution
dissolution studies? profile because they are unable to get pack from
Japan without Japanese prescription which is only
available in Japan, however the data available with
the firm shows that the product is highly soluble and
dissolves more than 85% within 15minutes in all
three media. Therefore, f2 calculation are not
required.
17. Do you have product development (R&D) The firm has dedicated R&D section with
section? reasonable facilities of equipment, human resource
and utilities.
18. Do you have necessary equipment The firm has all necessary equipment related to
available in product development section manufacturing available in R&D section for
for development of Teragis 100mg & 5mg manufacturing of Teragis 100mg
Tablets? T a b l e t s . The quality control related to
development work has been done in the routine
quality control laboratory; however, there are
dedicated HPLCs and Human Resource for this
purpose.
19. Are the equipment in product All the equipment used in product development
development section qualified? are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration
calibration / re-qualification program for programme. Re-qualification program for the
the equipment used in PD section? equipment used in PD section.
21. Do you have qualified staff in product The firm has 06 pharmacists and 01 chemist in
development section with proper manufacturing section of product development
knowledge and training in product section currently with suitable knowledge and
development? training in product. 03 QC Analysts are dedicated
for New products testing.
22. Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies of for the stability studies of:
Teragis 5 mg Tablets as required? Teragis 100mg Tablets with Batch Numbers:
18PD-2202-02-T, 18PD-2203-03-T & 18PD-2204-
04-T
23. Do you have any criteria for fixing the The criteria for fixing batch size is number of tablets
batch size of stability batches? required per testing and number of testing
frequencies.
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches.
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 The firm has developed and validated stability
method for testing of stability batches? indicating method for testing of their finished
product supported by forced degradation.
27. Do you have method transfer studies in Method transfer studies have not been done,
case when the method of testing being however, validation of the method has been
used by your firm is given by any other performed.
28. lab?
Do you have documents confirming the The firm has documents confirming the installation
qualification of equipments / instruments and operational qualification of the equipment /
being used in the test and analysis of instruments being used in the test and analysis of
Trelagliptin and the finished drug? Trelagliptin and the finished drug.
29. Do your method of analysis stability The firm’s method of testing is stability indicating as
indicating? supported by forced degradation.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per
Compliant? record available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports are available.
Trelagliptin testing?
32. Do you have some remaining quantities of The firm has remaining quantities of the
degradation products and stability batches? stability batches.
33. Do you have stability batches kept on The firm has kept all the three batches on
stability testing? real time and accelerated stability testing. Currently,
9 months studies have been completed with
34. Do you have valid calibration status for the satisfactory
The firm has results.
valid calibration status for the
Equipment used in Teragis100mg & 5mg equipment used in Teragis tablets production and
tablets production and analysis? analysis.
35. Do proper and continuous monitoring and The firm has 14 stability chambers, 02 for
control are available for stability chamber? accelerated and 12 for real time stability testing. All
the chambers are properly qualified. All the
chambers are provided with continuous power
supply and data loggers for continuous monitoring.
The data of data loggers is reviewed every 15th day.
36. Do related manufacturing area, equipment, The firm has manufacturing area provided with
personnel and utilities be rated as GMP necessary qualified equipment and utilities. The
compliant? manufacturing personnel are suitable in number
and qualification to run the manufacturing
processes as per GMP requirements. The
environmental conditions and their controls are also
proper. The overall GMP conditions can be rated as
compliant.
Conclusions:
On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Teragis (Trelagliptin) 100mg Tablets is verifiable to satisfactory level.
1. The related manufacturing area, equipment, personnel and utilities are GMP compliant and
well suited for the manufacturing of Teragis 100mg Tablets.
Recommendations:
1. The firm may kindly be granted necessary registration of Teragis 100mg tablets.
Sr. Name & Address Brand Name Type of Form, International Availability / Local
No. of Manufacturer / (Proprietary Name Initial Diary & Availability
Applicant + Dosage Form + Date, Fee
Strength), (including GMP Inspection Report Date &
Composition, differential fee), Remarks
Pharmacological Demanded Price
Group, / Pack size
Finished Product
Specification
1221. M/s Novamed Ledinil Tablet Form 5 Approved by USFDA
Pharmaceuticals Each film coated Diary No. 1928
(Pvt.) Ltd. 28 km tablet contains:- dated 20-04-2014
Ferozepur Road, Sofosbuvir…400mg Rs. 50,000/-
Lahore. Ledipasvir……90mg 14’s,
(Anti-viral) Rs.630,000/-
28’s
Rs.11,97,000/-
Previous Decision:
The case was presented in 260th meeting of Registration Board wherein Board deferred for
rectification of mentioned deficiencies and submission of stability data.
Evaluation by PEC:
Now the firm has submitted stability data along with documents as per checklist approved in 276 th
meeting of Registration Board for exemption from “On site investigation of submitted stability data”.
Detailsof submitted data are as under:
(Dy.# 31647 dated 19-09-2018)
Drug Ledinil Tablet
Name of Manufacturer M/s Novamed Pharmaceuticals (Pvt.) Ltd. 28 km Ferozepur Road, Lahore.
Manufacturer of API Sofosbuvir: M/s Nantong Chanyoo Pharmatech Co., Ltd. Jiangsu Province,
China.
Ledipasvir Co povidone: M/s Changzhou Pharmaceutical Factory, Jiangsu
province China.
API Lot No. Sofosbuvir: RD-RD-SFB-201706021
Ledipasvir Copovidone: 201705001
Description of Pack
Plastic jar
Frequency Accelerated: 0,1,3,6 month
Real Time: 0,3,6 month
Batch No. TP/078-T1/S1 TP/078-T1/S3 TP/078-T1/S4
Manufacturing Date 02-10-2017 03-10-2017 04-10-2017
No. of Batches 03
No.
1. COAS of API
Yes.
2. Approval of API by regulatory authority of country Copy of License for Drug Production (License #
of origin or GMP certificate of API manufacturer S.20160512) issued to M/s Nantong Chanyoo
issued by regulatory authority of country of origin. Pharmatech Co., Ltd. Jiangsu Province, China.
Yes
5. Documents confirming import of API etc. Copies of ADC attested invoices have been
submitted.
6. All provided documents will be attested (name, sign
documents.
Yes
Yes
1978.
Details of data submitted for exemption form On-site investigation
Administrative Portion
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 “Sofonil 400mg (Sofosbuvir) Tablets”, which
years. was conducted on 06th March, 2017 and was
presented in 268th meeting of Registration board held
on 20-21st March, 2017. Registration Board decided to
approve registration of Sofonil Tablets (Sofosbuvir
400mg) by M/s. NovaMed Pharmaceutical (Pvt.) Ltd.,
Lahore.
Following observation regarding HPLC system was
recorded in report:
 The HPLC software is 21CFR compliant as per
record available with the firm
 Audit trail on the testing reports were shown to
the panel during inspection.
2. Documents for the procurement of API with Firm has submitted following:
approval from DRAP (in case of import).  Copy of commercial invoice (No. CYI17214) for
Sofosbuvir (Batch #RD-SFB-201705281 & RD-
SFB-201706021), attested by AD (I&E), DRAP
Lahore on 29-06-2017.
 Copy of commercial invoice (No. CYI17160)
for Ledipasvir copovidone (Batch #201705001),
attested by AD (I&E), DRAP Lahore on 31-07-
2017.
3. Documents for the procurement of reference Firm has submitted DHL receipts of date 10-07-2017,
standard and impurity standards. with contents mentioned as “Ledipasvir/Velpatasvir
sample for lab testing purpose & weight of shipment
as 1Kg.
4. Approval of API/ DML/GMP certificate of Firm has submitted following:
API manufacturer issued by regulatory i. Copy of License for Drug Production
authority of country of origin. (License # S.20160512) issued to M/s
Nantong Chanyoo Pharmatech Co., Ltd.
Jiangsu Province, China.
ii. Copy of GMP certificate (certificate#
JS20180818) valid upto 09/07/2023 issued by
Jiangsu Food & Drug Drug Administration,
has been submitted.
5. Mechanism for Vendor pre-qualification Firm has submitted following:
i. SOP for Vendor Evaluation (Document#.
QC/Gen/080/073)
6. Certificate of analysis of the API, reference Firm has submitted following:
standards and impurity standards i. COA of Sofosbuvir (Batch. # RD-RD-SFB-
201706021) from M/s Nantong Chanyoo
Pharmatech.
ii. COA of working standard for Sofosbuvir
(Batch. # WSFB39-170401) from M/s
Nantong Chanyoo Pharmatech.
iii. COAs of Impurity standards mentioned in
COA of Sofosbuvir.
iv. COA of Ledipasvir Copovidone (Batch #.
201705001) from M/s Changzhou
Pharmaceutical Factory, Jiangsu province
China.
v. COA of Ledipasvir working standard (batch
#. WRS201601001) from M/s Changzhou
Pharmaceutical Factory, Jiangsu province
China.
vi. COAs of Impurity standards mentioned in
COA of Ledipasvir Co povidone
7. Documents for the procurement of excipients Firm has submitted commercial invoices for all the
used in product development? excipients used in the applied formulation, details of
which are as under:
8. List of qualified staff involved in product Firm has submitted R&D staff list comprising of 7
development with relevant experience. members.
Production Data
9. Authorized Protocols/SOP for the development Firm has submitted following:
& stability testing of trial batches. i. Copy of SOP for Ledinil tablet Development
(Document#. R&D/Doc/06/TP-78 effective
date 18-10-2017
ii. Stability study protocol for Ledinil tablet
(R7D/Doc/18/TP/078) approved on 25-09-
2017.
10. Complete batch manufacturing record of three Firm has Batch Manufacturing Record, including Pre-
stability batches. , Dispensing sheets, Master formulation & Standard
Manufacturing procedure, for all the three batches of
Ledinil tablet i.e.
Sr.# Batch No. Mfg. Date

1 TP/078-T1/S1 02-10-2017
2 TP/078-T1/S2 03-10-2017
3 TP/078-T1/S3 04-10-2017
11. Record of remaining quantities of stability Firm has submitted reconciliation sheet for use of
batches. Ledinil tablets for all the three stability batches.
QA/QC DATA
12. Record of Digital data logger for temperature Firm has submitted following:
and humidity monitoring of stability chambers i. Manually filled sheets for temperature &
(real time and accelerated) humidity record of Accelerated & Real time
conditions for the time period of 25-09-2017
to 28-09-2018.
ii. Moreover Firm has referred to Inspection
report dated 22-01-208, by the Area FID, for
the “Verification of data logging system of
Stability Chamber” with following
declaration:
 The scope/ ranges of the Stability Chambers was
as under:
i. 25°C & 60% RH
ii. 30°C & 65% RH
iii. 40°C & 75% RH
 Temperature & Humidity record of the chambers
was available at the time of inspection and was
being recorded twice a day.
 The firm also had provided automatic electric
supply by the Generator & USP system as back-
up arrangement, along with continuous alarm
system for monitoring.
 Both stability chambers were calibrated, their
performance qualification was also being
performed.
13. Method used for analysis of API along with  Firm has submitted Method of analysis & COA
COA. for Sofosbuvir & Ledipasvir copovidone from
M/s Nantong Chanyoo Pharmatech Co., Ltd. &
M/s Changzhou Pharmaceutical Factory, Jiangsu
province China respectively.
14. Method used for analysis of FPP & complete Firm has submitted following for both accelerated &
record of testing of stability batches (i.e. real time stability studies of all three stability batches:
chromatograms, lab reports, raw data sheets i. Method of analysis. (Document #.
etc.) QC/FP/006/N-108) with effective date of 08-
10-2017.
ii. Lab reports
iii. Raw data sheets
iv. HPLC Chromatograms (for Assay analysis &
Dissolution analysis)
15. Reports of stability studies of API from  Firm has submitted both accelerated (40°C ± 2°C
manufacturer. & 75±5%RH) stability studies & long term (25°C
± 2°C & 60±5%RH) stability studies reports of
three batches of Sofosbuvir of 6 months from M/s
Nantong Chanyoo Pharmatech Co., Ltd.
 Firm has submitted both accelerated 6 months

(40°C ± 2°C & 75±5%RH) stability studies &
long term 12 months (25°C ± 2°C & 60±5%RH)
stability studies reports of three batches of
Ledipasvir copovidone from M/s Changzhou
Pharmaceutical Factory, Jiangsu province China.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all the
excipients used in the applied formulation.
17. Drug-excipients compatibility studies. Firm has stated that since formulation of Dasvir tablet
is same as per Innovator Harvoni tablet so no need for
drug excipient compatibility.
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution
study protocol & results. The details of reference
product & Sample product are as follows:
Feature Reference Product of
product Novamed
Brand name Synget-LS Ledinil tablets
400/90mg of M/s
Getz Pharma
Batch No. 010F90 TP/78-T1/S1
Mfg. date 09-2017 10-2017
Expiry date 09-2019 --
 Comparative study dissolution study has been
performed in following mediums:
i. pH 1.2 HCl buffer with similarity factor of 86
ii. pH 4.5 Acetate buffer with similarity factor
of 52
iii. pH 6.8 Phosphate buffer with similarity factor
of 51
19. Compliance Record of HPLC software 21CFR Firm has submitted audit trail reports for HPLC
& audit trail reports on product testing. analysis of both stability studies.
th
Previous Decision: Registration Board in its 285 meeting decided to defer the case for confirmation of
data logging of stability chambers for applied product i.e. Ledinil Tablets, by Area FID.
Evaluation by PEC: Now the Inspection report has been received from Mr. Shoaib Ahmed (FID
lahore) vide letter No. 1456/2019-DRAP (L-V) dated 25-01-2019. The inspection was conducted on
22-01-2019 for the Verification of data of Stability Chamber. The observations & conclusion of
inspection are as under:
Observations:
 The scope/ ranges of the Stability Chambers was as under:
i. 30°C & 65% RH
ii. 40°C & 75% RH
 Temperature & Humidity record of the chambers was available at the time of inspection and was
being recorded twice a day.
 The firm also had provided automatic electric supply by the Generator & USP system as back-
up arrangement, along with continuous alarm system for monitoring.
 Both stability chambers were calibrated, their performance qualification was also being
performed.
Conclusion:
Keeping in view of above, the genuineness / authenticity of stability data submitted by the firm for
registration of Ledinil tablets has been verified.
The case is submitted for consideration of Registration Board
Evaluator PEC-III
Sr. No. Name & Address of Brand Name Type of Internation Previous
Manufacturer / (Proprietary Name Form, al DRB
Applicant + Dosage Form + Initial Diary Availabilit Decision /
Strength), & Date, Fee y / Local Remarks
Composition, (including Availabilit (if any)
Pharmacological differential y
Group, fee),
Finished Product Demanded GMP
Specification Price / Pack Inspection
size Report
Date &
Remarks
1222. M/s Global CORDIN Gel 4% Form 5 Not
Pharmaceuticals (Pvt.) available in
Ltd. Each gram contains:- Dairy No. reference
17440 dated SRAs,
Plot # 204-205, Chlorhexidine 09-10-2017 However
Industrial Triangle Gluconate 7.1% eq. to available in
Kahuta Road. Chlorhexidine…4%w Rs.50,000/- WHO
/w Model List
Islamabad. As per DRAP of Essential
(Bisbiguanide Policy. Medicines
Disinfectant) for Children
and Nepal,
BP Specs. Nigeria.
GMP
compliant
dated 12-
07-2017.
Drug CORDIN Gel 4% (Chlorhexidine Gluconate)
Name of Manufacturer M/s Global Pharmaceuticals (Pvt.) Ltd. Islamabad.
Manufacturer of API M/s Unilab Chemicals & Pharmaceuticals (Pvt.) Ltd. India
API Lot No. F/006/16
Description of Pack Aluminum Tubes
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 26 Weeks
Real Time: 26 Weeks
Frequency Accelerated: 0,6,8,12,16,20,24,26 (Weeks)
Real Time: 0,6,8,12,16,20,24,26 (Weeks)
Batch No. T-006(Q) T-007(Q) T-008(Q)
Batch Size 100 Tubes 100 Tubes 100 Tubes
No. of Batches 03
Sr. No. Documents To Be Provided Status
1. COA of API
Yes
2. Approval of API by regulatory authority of Copy of Certificate of a Pharmaceutical

country of origin or GMP certificate of API Product (Chlorhexidine Gluconate
manufacturer issued by regulatory authority of Solution BP) marked YES at 3.3, issued
country of origin. by Food and Drug Administration
(Maharashtra) India is submitted.
Importing Country is mentioned ‘As per
Annexure’; however the annexure is not
enclosed.
3. Protocols followed for conduction of stability Yes
study and details of tests.
4. Data of 03 batches will be supported by attested Yes
respective documents like chromatograms,
5. Documents confirming import of API etc. Copy of ADC (Islamabad) attested
Commercial Invoice is submitted.
6. All provided documents will be attested (name, Yes
sign and stamp) for ensuring authenticity of
data / documents.
Rules, 1978.
REMARKS OF EVALUATOR1
 The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 Lab
Scale Batches.
 Copy of Certificate of a Pharmaceutical Product (Chlorhexidine Gluconate Solution BP) marked
YES at 3.3, issued by Food and Drug Administration (Maharashtra) India is submitted. Importing
Country is mentioned ‘As per Annexure’; however the annexure is not enclosed.
The Registration Board was apprised that the firm has submitted copy of GMP certificate No. 6077690
issued by FDA, Maharashtra, India for M/s Unilab Chemicals & Pharmaceuticals (Pvt.) Ltd. India.
Decision: Registration Board deliberated that it has been decided that onsite inspection for verification of
data will be exempted as decided in instant meeting. Thus the Board decided as follows:
Onsite inspectionby following panel to confirm genuineness/ authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc.
Additional Director (E&M), DRAP Islamabad
Director DTL Rawalpindi
Area FID, DRAP, Islamanbad
OR
Firm can submit requisite documents as decided in instant meeting in Case No. 02 (On site investigation
of submitted data).
Report on Inspection of Authenticity / Genuineness of data submitted for registration of Cordin gel
(Chlorhexidine) 4 % by M/s. Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial
Estate Triangle, Kahuta Road, Model Town, Islamabad.
Inspection Date and Time: 09th & 10th January, 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 Cordin gel (Chlorhxidine) 4 % with
following composition:
CORDIN Gel 4%
Each gram contains:-
Chlorhexidine Gluconate 7.1% eq. to Chlorhexidine…4%w/w
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.
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 inspection is summarized as under:
Detail of Inspection:
Q.
No Question Observation by panel
.
1. Do you have Chlorhexidine Gluconate Solution BP
documents confirming Invoice Number: E-008/2016-17
the import of API ADC attestation date: 11.05.2016
including approval Exporter: M/s Unilab Chemicals and Pharmaceuticals Pvt Ltd W-32,
from DRAP? M.I.D.C. Phase-II Dombivli (East) District: Thane
Manufacturer: as above
Batch No. F-006/16
Mfg. Date: Jan, 2016
Exp. Date: Dec,2018
Quantity: 5kg
2. What was the rationale The firm has submitted that manufacturer of API was selected on the basis
behind selecting the of Valid GMP, Client List of API manufacture contains International and
particular manufacturer Local clientele, Stability Data (Accelerated and Real Time).
of API? 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 The firm imported following reference and impurity standards:
documents confirming  Chlorhexidine Gluconate Solution Working Standard from the
the import of Source/Manufacturer (Batch No. WS/006/16; WS/001/17;
Chlorhexidine WS/003/18).
Gluconate Solution BP  Firm has also imported CRS containing impurities A, B, F, G, H, I,
reference standard and J, K, L, N and O for identification/quantification of specified
impurity standards? impurities from Cavax Entrprises vide purchase order no. NIL and
Delivery Challan No. GP/611 dated 28-08-2017.
 For specified impurity P the firm imported reagent grade
Chloroaniline R from Sigma-Adrich vide invoice no. Inv. 3240
dated 28.01.2016.
Remarks:
 Firm did not imported BP reference standard of API.
 The CRS is imported after date of manufacturing of Trial Batches
i.e. 14-02-2017 as per BMR submitted.
4. Do you have certificate The firm has submitted COAs of following drugs (APIs)/materials of
of Analysis of the API, source as mentioned below:
reference standards and Chlorhexidine Gluconate Solution BP
impurity standards?  Chlorhexidine Gluconate Solution BP Working Standard
 Reagent Grade for Impurity P (Ph. Eur.)
 CRS containing impurities A, B, F, G, H, I, J, K, L, N and O
5. Do you have GMP Chlorhexidine Gluconate Solution BP

certificate of API The firm has submitted copy of GMP certificate in the name of
manufacturer issued by Manufacturer that is “M/s Unilab Chemicals and Pharmaceuticals Pvt Ltd
regulatory authority of (705082) W-32, M.I.D.C. Phase-II Dombivali Manpada - 421204 District:
country of origin? Thane (Zone6)” of Chlorhexidine Gluconate Solution BP by the
Certifying Authority of “Food & Drugs Administration (Maharashta
State), India.”
Validity: 24-08-2015 to 23-08-2016
Remarks:
 The GMP certificate mentions that this certificate is issued for
purpose of RAJASTHAN MEDICAL SERVICES
CORPORATION LTD., JAIPUR, RAJASTHAN
(GOVERNMENT TENDER PURPOSE).
6. Do you use API The firm stated that they have used pharmacopoeial (B.P.) method for
manufacturer method testing of API.
of testing for testing
API?
7. Do you have stability Firm has submitted data of long term stability studies of three batches
studies reports on API? F/010/09 (Mfg: Jan, 2009), F/014/09 (Mfg: Jan, 2009) & F/015/09 (Mfg:
Jan, 2009) up to 48 months and accelerated data up to 7 months conducted
by the API manufacturer M/s Unilab Chemicals and Pharmaceuticals Pvt
Ltd (705082) W-32, M.I.D.C. Phase-II Dombivali Manpada - 421204
District: Thane (Zone6) under conditions of Zone-IV A that is 30 Co + 2
Co & 65 % RH + 5 % and 40 Co + 2 Co & 75 % RH + 5 % for API namely
Chlorhexidine Gluconate Solution BP. The data submitted by the API
manufacturers lies within the limits for the Assay & pH.
Remarks:
 The firm acquired old stability data from the API manufacturer
instead of latest.
8. If yes, whether the The firm has submitted the stability testing studies showing no capability
stability testing has of calculating API quantitatively in a precise manner free from impurities,
been performed as per excipients and degradation products (as per definition of SIM). No
SIM method anddegradation products have been quantified. The applicant relies on data of
degradation products manufacturer.
have been quantified? However, upon enquiring said observation, the firm submitted an open
part of Drug Master File (DMF) received from the source i.e. M/s Unilab
Chemicals and Pharmaceuticals Pvt Ltd (705082) W-32, M.I.D.C. Phase-II
Dombivali Manpada – 421204 verifying stability conducted on SIM
method.
9. Do you have method The firm stated that they have used Pharmacopoeial (B.P.) method for
for quantifying the quantifying the impurities in the API.
impurities in the API?
10. Do you have some The firm has submitted remaining quantities of the API, reference standard
remaining quantities of and impurities standards as per details below:
the 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 The firm purchased the excipients used in the applied formulation from
documents confirming local suppliers as per details below:
the import of the used
S# Item B# Local Import from Release
excipients?
name Supplier Date from
QC
1 Guar A01/2016100 Scientific GUANGRAO 22/07/2016
Gum Trader LIUHE
CHEMICAL
CO., LTD.
2 Sodium EADK31 Chief DUKSAN 19/02/17
Acetate scientific PURE
Agency CHEMICALS
CO., LTD
13. Do you have test The firm has performed tests on above mentioned excipients and hence has
reports and other test reports and other records on the excipients used.
records on the
excipients used?
14. Do you have written The firm has written and authorized protocols for the development of
and authorized Cordin
protocols for the Gel 4% (Chlorhexidine Gluconate Solution BP). But submitted
development of Cordin documented was not in accordance with ICH Q-8 which pertains to
Gel 4% Pharmaceutical Development. The firm was advised to improve the
(Chlorhexidine submitted protocol in the light of said document.
Gluconate Solution
BP)?
15. Have you performed The firm has not performed Drug-Excipients compatibility studies as their
Drug-excipients formulation (API & Excipients) is similar/comparable to that of the
compatibility studies? Umbipro Gel by GSK approved by EMA.
16. Have you performed The product is Pharamcopoeial (B.P.) wherein dissolution is not a
comparative parameter to be measured as product quality specifications. The firm
dissolution studies? submitted an evidence of WHO multisource (generic) development
guidelines justifying not performance of the comparative dissolution as the
dosage form of applied drug is aqueous Gel. However, they have
performed quality comparison with already approved similar formulation
namely Sepidyl Gel of M/s Aspin Pharma (pvt) Ltd. Karachi by DRAP for
physical identification and pH and assay testing.
17. Do you have product The firm possesses an approved Research & Development (R&D) and
development (R&D) Validation Department for product development studies.
section
18. Do you have necessary The firm has following necessary equipment in R & D section though for
equipment available in the development of Cordin Gel.
product development
section for
development of Cordin
Gel?
19. Are the equipment in The equipment used in production and analysis of trial batches are
product development qualified as per details mentioned in reply of above question # 18.
section qualified?
20. Do you have proper The firm has calibration program for the equipment used in production and
maintenance/calibratio QC as per details mentioned in reply of question 18.
n/re-qualification
program for the
equipment used in PD
section?
21. Do you have qualified The firm has appointed a team of following technical personnel:
staff in product
development section Sr. Employee Designation Qualification Experience
with proper knowledge #. Name
and training in product 1. Mr. Manager M. Sc. 17 years
development? Muhammad R&D Analytical
Jamil 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 Pharmacist Pharm D 06 month
Zahra
22. Have you The firm has manufactured following three stability batches for the
manufactured three stability studies of Cordin Gel:
stability batches for the
stability studies of S. Stability Batchs Batch Sizes
Cordin No.
Gel as required? a. T006(Q) 100 x 5 gm
Tubes
b. T007(Q) 100 x 5 gm
Tubes
c. T008(Q) 100 x 5 gm
Tubes
23. Do you have any The firm has set the criteria for fixing the batch size of stability batches
criteria for fixing the as/& derived the quantity sufficient for the studies both in accelerated and
batch size of stability real time studies to cover all testing time points as per details below:
batches?
S. Tubes Tubes for Total packs
No. /Packs for accelerated per batch
real time studies required
studies
a. 48 tubes 24 tubes 48 + 24= 72
tubes
Batch size = 100 x 5 gm tubes= 500 gm = 0.5 kg

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 The firm has controlled protocol of testing of stability batches of applied
for stability testing of formulation at 30 Co + 2 Co & 65 % RH + 5 % with them for real time
stability batches? studies and at 40 Co + 2 Co & 75 % RH + 5 % for accelerated studies.
26. Do you have developed The firm has used Pharmacopoeial (B.P) method for testing of finished
and validated the drug in their stability studies. The firm has also submitted a report
method for testing of verifying the validation studies of the analytical method covering
stability batches? following parameters of validation:
i. Specificity
ii. Precision
a. Repeatability
iii. Accuracy
Remarks:
The firm has started initial testing of samples placed on stability on
20.03.2017 while the validation of testing method performed on
26.03.2017.
27. Do you have method The firm has not conducted method transfer studies. According to the firm
transfer studies in case since their analytical method is Pharmacopoeial hence no method transfer
when the method of studies are required.
testing being used by
your firm is given by
any other lab?
28. Do you have The firm showed documents confirming the qualification of equipment /
documents confirming instruments being used in the test and analysis of APIs and the finished
the qualification of drug.
equipments/
instruments being used
in the test and analysis
of APIs and the
finished drug
29. Do your method of The firm’s method of testing is stability indicating for stability testing of
analysis stability their finished product being pharmacopoeial (B.P). However, the data
indicating? sheet submitted by firm does not verify the testing of impurity on samples
kept on stability studies though, firm submitted an impurity testing report
for p-Chloroaniline on samples of all three batches conducted on six
month time interval dated 27.09.2017 but document shows no
temperature/humidity conditions and the manufacturing date written as
07/2017. The firm has conducted impurity testing one time at 6 month
time point it was discussed to conduct the impurity testing at initial and
end time point (i.e., 0 and 6) to get an exact verification of impurity
profiling/level.
30. Do your HPLC Firm has 1 HPLC dedicated for R&D testing at the time of studies
software is 21CFR conducted (now they have 2) and is 21 CFR II compliant. This HPLC
compliant? system is used for stability studies of Cordin Gel. 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 A complete trail of such testing was found available and verifiable from
Trail reports on Cordin log books, analytical test reports and software of HPLC as well.
Gel 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?
33. Do you have stability The firm has completed the accelerated stability testing on the three
batches kept on stability batches of Cordin Gel. Also the firm has completed the real time
stability testing? stability testing up to 18 months on all three batches with satisfactory
results.
34. Do you have valid The firm has valid calibration status for the equipment used in Cordin
calibration status for Gel production and analysis as per record available during onsite visit.
the equipments used in
production in analysis?
35. Do proper and Continuous power supply and monitoring with back up from generator and
continuous monitoring UPS are available for stability chamber to address the problem of
and control are interrupted power supply or load shedding. Portable digital data loggers
available for stability are available for continuous monitoring of temperature and humidity
chamber? conditions of stability chamber. The firm submitted data of temperature
and humidity conditions of stability chambers used for accelerated and real
time studies date-wise for every next hour.
36. Do related The related manufacturing area, equipment, personnel and utilities are
manufacturing area, rated as GMP compliant.
equipment, personnel
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 Cordin
Gel is verifiable to a satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and suitable
for the manufacturing of Cordin
Gel, therefore, the panel recommends the registration of Cordin
Gel in the name of the manufacturer.
Evaluator PEC-V
1223. Name and address of M/s Sami Pharmaceuticals Pvt. Ltd
Brand Name +Dosage Form + Iburo Injection 800mg/8ml
Strength
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 Innovator specifications
Specifications
Pack size & Demanded Price Rs. 13,500/vial
Rs. 13,5000/10’s vial
Reference Regulatory Caldolor by Cumberlands Pharmaceuticals
Authorities
Me-too status (with strength N/A
and dosage form)
GMP status Last GMP Inspection dated 3-10-2017 with conclusive remarks of
good level of GMP compliance.
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
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH
Time Period Real Time: 06 Months
Accelerated: 06 Months
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
(1333 vials) (1333 vials)
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
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,
country of origin or GMP certificate of API Orangeburg, South Carolina (SC) 29115, United
manufacturer issued by regulatory authority of States (USA) 12/31/2019
country of origin.
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 Yes
Rules, 1978.
● 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
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
4. equivalent to 1333 vials? initial 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
The batch no Lab-01 the standard 3 was
at 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
5. sample on 8 July 2018 at 2:34 am.
Ibuprofen sequence of injections started on Saturday,
Justify the time gap between standard
July 07, 2018 at 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
• Method of analysis of assay has gradient
program of 75 minutes
• Complete analysis at single frequency of stability
The batch no Lab-01 the standard 3 was at 3rd and 6th
ran on 3 April 2018 at 6:09 pm and month consist of at least 15 runs
6. sample on 4 April 2018 at 3:00 am. • Similarly, at 3rd month time point, sequence of
Justify the time gap between standard injections started on Tuesday, April 03, 2018 at 3:37:22
and sample. (Real time Condition). 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 Due to system behavior, extra peak appears on both
7. and samples at RT between 50 min standard and samples that means this peak is due to
and 60minutes, especially in standard system response, 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 Injection 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. 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”.
4. Dr. Rafeeq Alam, Meritorious Professor, Department of Pharmacology, University of Karachi,
Karachi, Member Registration Board.
5. Mr. Aslam Shah, Member Registration Board.
6. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
databases were also audited. The details of investigation may be summarized as under:
S.No. Description Observation by panel

The firm has imported 5.0kg Ibuprofen raw material from M/s SI
Group Inc, United States, vide invoice no. 442831 dated 05-09-
Do you have documents confirming 2017 and has obtained approval from DRAP Karachi.
1 the import of API including approval Batch No. Quantity Imported
from DRAP? 4050-3159 5.0kg
There is proper vendor evaluation process being implemented by

the firm and the rationale behind vendor selection is controlled
Do you have any rationale behind through:
2
selecting the particular manufacturer
 Postal Audit checklist
 GMP approval by competent authority
The firm has imported EP grade 250mg of reference standard and
Do you have documents confirming impurity standard from EDQM
3 the Import of Reference standard and
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
The API manufacturer is registered establishment by USFDA the
Do you have any approval of API or USFDA identifier is 3011012288 which is valid till 31-Dec-2019.
GMP certificate of manufacturer The firm has also provided copy of GMP certificate issued by
5
issued by regulatory authority of TGA Australia.
country of origin?
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 conducted
7 on API? 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 development
14 protocols for the development of Iburo 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
studies? physical, chemical and microbiological analysis.
16
The firm has product development (R&D) Section with the

facility of manufacturing oral and topical preparation only. The
product under consideration has been manufactured in routine
Do you have Product Development /
sterile area of the firm. The firm has dedicated analytical section
17 R&D 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 area
available in product development for development of Iburo 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 area
19 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 10.5L.
batches for the stability studies of Iburo 800mg/8ml Injection
Iburo 800mg/8ml Injection as Batch No Date of Mfg. Expiry Date
required? Lab-01 12-17 11-19
22
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 batch size of stability of batches? number of Injection per testing frequencies.
The firm has complete record for the stability batches of Iburo
Do you have complete record of 800mg/8ml Injection.
24
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 finish
26 the method for testing of stability product Iburo 800mg/8ml Injection, based on method of testing
batches 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 the
28 instruments being used in the test and 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 only.
32 quantities of degradation products and
stability batches?
The firm has three stability batches kept on stability for Real time
Do you have batches kept on stability
33 stability testing. 9 Months Real Time and 6 months Accelerated
testing?
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.
Any other query raised by the
Pharmaceutical Evaluation Cell?
An intense peak was observed for 1. The panel observed a peak of similar nature in mobile
batch no. Lab-02 in both standard and phase run at same retention time, this type of peak is also
sample at Retention time between observed in other runs too. However, the peak area is
37 50min and 60mins. The firm provided very less as compared to the mentioned peak.
the following justification that “Due to 2. The panel disagrees with the firm’s response and
system behaviour extra peak appears conclude the peak to be peak 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.
Evaluator PEC-VIII
1224. Name and address of M/s. Global Pharmaceuticals, Islamabad.
Brand Name +Dosage Form + Tamsol S Tablets 0.4mg/6.0mg
Strength
Composition Each bilayer modified release tablet contains:
Tamsulosin hydrochloride…0.4mg
Solifenacin succinate… 6.0mg
Diary No. Date of R& I & fee Duplicate Dossier
Pharmacological Group Alpha-adrenoreceptor antagonists/Muscarinic Antagonist.
Me-too status (with strength and N/A
dosage form)
GMP status ----
Drug Tamsol S Tablets 0.4mg/6.0mg
Name of Manufacturer M/s. Global Pharmaceuticals, Islamabad.
Manufacturer of API Tamsulosin hydrochloride(granules): M/s Alphamed, Telangana State, India.
Solifenacinsuccinate(granules):M/s Alphamed, Telangana State, India.
API Lot No. Tamsulosin hydrochloride: 8000173-041(A)
Solifenacin succinate: 8000173-041(B)
Description of Pack
10’s : alu/alu blister
Accelerated:06Months
Frequency Real Time: Initial,3,6 Months(on going)
Accelerated: Initial,1,2,3,4,6 Months
(Only Identification, Appearance & Assay have been carried out at (1st, 2nd&
4th month)
Batch Size 25000 tablets
25000 tablets 25000 tablets

No. of Batches 03
Date of Submission Duplicate dossier
No.
1. COA of API
Not submitted
2. Approval of API by regulatory authority of country Copy of GMP certificate having a number 9267/E (M)
of origin or GMP certificate of API manufacturer TS/2017 issued M/s Alphamed, Telangana State by
issued by regulatory authority of country of origin. DCA Government of Telangana valid for a period of
two years from date of issue 07-2017.
(This certification is for export of drugs only)
documents.
7. Commitment to continue real time stability study Yes
8. Commitment to follow Drug Specification Rules, Yes
1978.
The panel is requested to seek clarification by the firm for the following:
Why the dissolution test at 1st, 2nd& 4th month of accelerated Stability studies has not been carried out by the firm
for all three trials (Batch No. T01, T02, T03).
Report on Inspection of Authenticity / Genuineness of data submitted for registration of bilayer
modified release Tamsol-S (Tamsulosin hydrochloride…..0.4 mg Solifenacin succinate……..6.0 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: 14th &21st January, 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 Tamsol-S with following composition:
Tamsol-S Tablet
Each bilayer modified release tablet contains:-
Tamsulosin hydrochloride.…..0.4 mg
Solifenacin succinate………….6.0 mg
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 alongwith the clarification of following point.
a) Why the dissolution test at 1st 2nd and 4th month of accelerated stability has not been carried
out by the firm for all three trials of Tamsol S tablet 0.4mg/6.0mg (Batch # T-01, T-02 & T-
03).
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
databases were also audited. The details of inspection is summarized as under:
Detail of Inspection:
Q.
Question Observation by panel
No.
1. Do you have documents Solifenacin Succinate Granules 6 % w/w:
confirming the import of API
including approval from DRAP? Invoice Number: 034/2017-18 dated 11.07.2017
ADC attestation date: 04.08.2017
Exporter/manufacturer:M/s Alphamed Formulations (Pvt.)
Ltd.,Survey No. 225, Sampanbole (Village) Shameerpet
(Mandal). Medchal –Malkajgiri Dist. -500078, Telangana
State, India.
Batch No. 8000173-041 (B)
Mfg. Date: May, 2017
Exp. Date: April, 2019
Quantity: 1 Kg
Tamsulosin Hydrochloride:
Invoice Number: 034/2017-18 dated 11.07.2017
ADC attestation date: 04.08.2017
Exporter/Manufacturer:M/s Alphamed Formulations (Pvt.)
State, India.
Batch No. 8000173-041 (A)
Mfg. Date: May, 2017
Exp. Date: April, 2019
Quantity: 2.25 Kg
2. What was the rationale behind The firm has submitted a comparison sheet showing different
selecting the particular parameters to compare among 4 different sources and the
manufacturer of API? conclusion based upon which the applicant selected the API
manufacturer that is M/s Alphamed Formulations (Pvt.)
State, India.
3. Do you have documents The firm imported following working standards from MSN
confirming the import of Laboratories Pvt. Ltd. Sun Pharma:
reference standard of Solifenacin  Solifenacin succinate working standard
Succinate and Tamsulosin o (B#SF0090816)
Hydrochloride and impurity o Date of Standardization: 19th May, 2017
standards? o Validity Date: 18 May, 2018
 Tamsulosin hydrochloride working standard
o Batch No. (B#PNOTMSFL005)
o Date of Standardization : 16th November,
2016
o Validity Date: 15 November, 2017
o Batch No. (B#PNOTMSFL006)
o Date of Standardization: 6th October, 2017
o Validity Date: 5thOctober, 2018
4. Do you have certificate of The firm has submitted COAs of following APIs as obtained
Analysis of the API, reference from source mentioned below:
standards and impurity standards?  Solifenacin Succinate Granules 6 % w/w
 Solifenacin succinate working standard
 Tamsulosin Hydrochloride Granules 0.2 % w/w
5. Do you have GMP certificate of The firm has submitted copy of GMP certificate in the name
API manufacturer issued by of Manufacturer that is “M/s Alphamed Formulations (Pvt.)
regulatory authority of country of Ltd.,Survey No. 225, Sampanbole (Village) Shameerpet
origin? (Mandal). Medchal –Malkajgiri Dist. -500078, Telangana
State, India.”
Valid upto: 19.12.2018
6. Do you use API manufacturer’s The firm stated that they have used API testing method of
method of testing for testing API? source that is M/s Alphamed Formulations (Pvt.) Ltd.,Survey
No. 225, Sampanbole (Village) Shameerpet (Mandal).
Medchal –Malkajgiri Dist. -500078, Telangana State, India.
7. Do you have stability studies Firm has submitted data of long term stability studies at 30
reports on API? Co+ 2 Co & 65 % RH + 5 % of three batches namely
8000173-039(A)(Mfg: February, 2017), 8000173-
045(A)(Mfg: March, 2017) & 8000173-046(A)(Mfg: March,
2017) up to 12 months and accelerated data at 40 Co+ 2 Co &
75 % RH + 5 % up to 6 months of Tamsulosin
Hydrochloride Granules 0.2 % w/w and long term stability
studies at 30 Co+ 2 Co & 65 % RH + 5 % of three batchesof
Solifenacin Succinate Granules 6 % w/w 8000173-
039(B)(Mfg: February, 2017), 8000173-045(B)(Mfg: March,
2017) & 8000173-046(B)(Mfg: March, 2017) up to 12
months and accelerated data at 40 Co+ 2 Co & 75 % RH + 5
%up to 6 months
Remarks:
 The stability data shows various observations like:
o The data mentions 3 months difference
between manufacturing date and testing
date at 0 time point (T0). There is need to
ask from source by the applicant for hold-
time studies ensuring storage condition and
quality of granules.
8. If yes, whether the stability The firm has submitted the stability testing data of source
testing has been performed as per showing testing of unknown impurities.
SIM method and degradation
products have been quantified?
9. Do you have method for The firm has method for calculating/quantify unknown
quantifying the impurities in the impurities in API.
API?
10. Do you have some remaining The firm has submitted remaining quantities of the API,
quantities of the API, its reference reference standard and impurities standards as per details
standard and impurities below:
standards? S# Entity Name Batch No.
Received Consumption Consumed Remaining amount
amount Details amount (approx..)
Raw material
5g 995gm
Testing
Pre formulation
Solifenacin 150g 845gm
trial
1 Granules 8000173-041(B)
1kg
Three Stability
Batches 750g 95gm
T-01,T-02,T-03
Raw material
5g 2245gm
Testing
Pre formulation
Tamsulosin 300 1945gm
2 8000173-041(A) 2.25kg trial
Granules
Three Stability
Batches 1500 445gm
T-01,T-02,T-03
Solifenacin  Raw material
Approx:
3 (Working. SF0090816 500mg Testing 350mg
150mg
Standard )  Stability Testing
Tamsulosin  Raw material
Approx:
4 (Working. PNOTMSFL005 500mg Testing g 400mg
100mg
Standard )  Stability Testing
Tamsulosin
Approx:
5 (Working. PNOTMSFL006 500mg  Stability Testing 450mg
50mg
Standard )
11. Have you used pharmaceutical The firm has used pharmaceutical grade excipients as
grade excipients? indicated from the COAs of excipients submitted by firm.
12. Do you have documents The firm imported the excipient used in the applied
confirming the import of the used
formulation:
excipients?  Magnesium Stearate (Batch No.20160220) from
M/s Hangzhou Zhongbao Import and Export
Corporation., Ltd. Hangzhou, China.
 Tabcoat TC Red (Batch No.SH589925) from M/s
Colorcon Ltd. England.
13. Do you have test reports and The firm has performed tests on above mentioned excipients
other records on the excipients and has test reports and other records on the excipients used.
used?
14. Do you have written and The firm has written and authorized protocols for the
authorized protocols for the development of Tamsol-S Tablet (Tamsulosin
development of Tamsol-S Tablet hydrochloride…..0.4 mg Solifenacin succinate……..6.0
(Tamsulosin mg). But submitted documented was not in accordance with
hydrochloride…..0.4 mg ICH Q-8 which pertains to Pharmaceutical Development.
Solifenacin succinate……..6.0 The firm was advised to improve the submitted protocol in
mg)? the light of said document.
15. Have you performed Drug- The firm has not performed Drug-Excipients compatibility
excipients compatibility studies? studies as the firm claims that their formulation (API &
Excipients) is similar/comparable to that of the Vesomni 6
mg/0.4 mg modified release tablets approved by Netherland.
16. Have you performed comparative The firm has performed comparative dissolution studies at
dissolution studies? three pH values that is 1.2, 4.5 and 6.8. The results show F2
values greater than 50 that is 86.2.
17. Do you have product The firm possesses an approved Research & Development
development (R&D) section (R&D) and Validation Department for product development
studies issued by DRAP vide letter No. F. 1-1/69-Lic.(Vol-
II) dated 13-06-2017.
18. Do you have necessary equipment Yes, the firm has following necessary equipment in R & D
available in product development section though compression for the development of Tamsol-
section for development of S Tablet has been carried in General Production Tablet
Tamsol-S Tablet? Section of the firm having commercial scale double layer
rotary tablet compression machine (Model: ZP-26; Make:
Shanghai-China; Equipment ID – GL/PRD/545; IQ-
290/01-15;OQ-291/01-15 & PQ-292/01-15)
19. Are the equipment in product The equipment used in production and analysis of trial
development section qualified? batches are 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
maintenance/calibration/re- production and QC as per details mentioned in reply of
qualification program for the question 18.
equipment used in PD section?
21. Do you have qualified staff in The firm has appointed a team of following technical
product development section with personnel:
proper knowledge and training in
Sr. #. Employee Name Designation Qualification Experience
product development? 7. Mr Muhammad Jamil Manager R&D M. Sc. Analytical 17 years
Chemistry
8. Dr. Tanseer Abbas Executive Pharm -D 06 Years
9. Atifali Executive M. Sc. Chemistry 5 years
10. Dr. AnasUllah Senior analyst Pharm D 4.5 years
11. Muhammad Zubair Analyst M. Sc. Chemistry 1.5 Years
12. Miss kainat Zahra Pharmacist Pharm D 06 month
22. Have you manufactured three The firm has manufactured following three stability batches
stability batches for the stability for the stability studies of Tamsol-S Tablet:
studies of Tamsol-S Tablet as
required? S. Stability Batches Batch Sizes
No.
d. T-01 2,500
e. T-02 2,500
f. T-03 2,500
23. Do you have any criteria for The firm has set the criteria for fixing the batch size of
fixing the batch size of stability stability batches as/& derived the quantity sufficient for the
batches? studies both in accelerated and real time studies to cover all
testing time points as per details below:
S. Packs for real Packs for Total packs per

No. time studies accelerated batch required
studies
1. 35 30 35 + 30= 65
Batch size = 10 x 1 x 250 = 2,500 tablets

24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? 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 The firm has controlled protocol of testing of stability
stability testing of stability batches of applied formulation at 30 Co+ 2 Co & 65 % RH +
batches? 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 The firm has developed an In-house method for testing of
validated the method for testing finished product which has been used in the stability studies.
of stability batches? The firm has also submitted a report verifying the validation
studies of the analytical method covering following
parameters of validation:
iv. Specificity
v. Linearity and Range
vi. Accuracy and Recovery
vii. Precision
a. Repeatability
viii. Ruggedness
ix. Robustness
Remarks:
The firm has not derived sensitivity studies covering LOD
(Limit of Detection) and LOQ (limit of Quantification).
However, firm submitted statistically calculated values of
LOD & LOQ for Tamsol-S Tablet (Tamsulosin
hydrochloride…..0.4 mg Solifenacin succinate……..6.0
mg) from linearity studies as follows:
Solifenacin Succinate Tamsulosin HCl
LOD 0.569mcg/ml 0.044mcg/ml
LOQ 1.72mcg/ml 0.133mcg/ml
27. Do you have method transfer The firm has not conducted method transfer studies.
studies in case when the method According to the firm they have developed their method of
of testing being used by your firm testing in their own laboratory hence no need of such method
is given by any other lab? transfer studies.
28. Do you have documents The firm showed documents confirming the qualification of
confirming the qualification of equipment / instruments being used in the test and analysis of
equipments/instruments being APIs and the finished drug.
used in the test and analysis of
APIs and the finished drug
29. Do your method of analysis The firm method of testing is stability indicating which has
stability indicating? been used in stability studies of their finished product. The
firm has conducted impurity testing one time at 6 month time
point it was suggested to conduct the impurity testing at 0
and 6 time point to get an exact verification of impurity
profiling.
30. Do your HPLC software is Firm has 1 HPLC dedicated for R&D testing at the time of
21CFR compliant? studies conducted (now they have 2) and it is 21 CFR
compliant. This HPLC system is used for stability studies of
Tamsol-S 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 found available and
verifiable.
31. Can you show Audit Trail reports A complete trail of such testing was found available and
on Tamsol-S Tablet testing? verifiable from log books and software of HPLC as well.
32. Do you have some remaining The firm has remaining quantities of stability batches as per
quantities of degradation products following details:
and stability batches?
33. Do you have stability batches The firm has completed the accelerated stability testing on
kept on stability testing? the three stability batches of Tamsol-S Tablet. Also the firm
has completed the real time stability testing up to 12 months
on all three batches with satisfactory results.
34. Do you have valid calibration The firm has valid calibration status for the equipments used
status for the equipments used in in production and analysis of Tamsol-S Tablet as per record
production and analysis? available during onsite visit and as per details mentioned in
reply of above question # 18.
35. Do proper and continuous Continuous power supply and monitoring with back up from
monitoring and control are generator and UPS are available for stability chamber to
available for stability chamber? address the problem of interrupted power supply or load
shedding. Portable digital data loggers are available for
continuous monitoring of temperature and humidity
conditions of stability chamber. The data of temperature and
humidity conditions of stability chambers used for
accelerated and real time studies date-wise for every next
hour has been verified from record.
36. Do related manufacturing area, The related manufacturing area, equipment, personnel and
equipment, personnel and utilities utilities are rated as GMP compliant. The firm has valid
be rated as GMP compliant? GMP certificate issued by Drug Regulatory Authority of
Pakistan with validity period as 24-10-2018 till 23-10-2021.
37. st
Why the dissolution test at 1 , The firm has performed complete testing including
2nd& 4th month of accelerated dissolution at 0, 3 and 6 month time points for all three trials
stability studies has not carried of Tamsol-S tables 0.4mg/6.0mg (Batch No. T01, T02, T03)
out by the firm for all three trials in compliance to ICH Q1A(R2) guidelines. However, at time
of Tamsol-S tables 0.4mg/6.0mg point 1 and 2 the firm has performed appearance,
(Batch No. T01, T02, T03). identification and assay while relying on dissolution profile
performed at 0 and 3 time point.
Furthermore, the decision regarding time points for
Accelerated stability studies i.e. (0, 1st, 2nd, 3rd, 4th& 6th
months) was taken in 276th Meeting of Registration Board
held on 22-25 Nov, 2017 (date of confirmation of minutes
27-29th Dec, 2017), while manufacturing of trial batches and
finalization of respective study plan has been carried out in
September, 2017.
The firm assured to strictly comply in future the approved
guidelines of Registration Board for stability studies.
Conclusion & Recommendations:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted
by the firm for registration of Tamsol-S Tablet is verifiable to a satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and
suitable for the manufacturing of Tamsol-S Tablet, therefore, the panel recommends the
registration of Tamsol-S Tablet in the name of the manufacturer.
1225. Name and address of manufacturer / M/s Sami Pharmaceuticals (Pvt) Limited. F-95 S.I.T.E.
Applicant Karachi.
Brand Name +Dosage Form + Strength Tefod Tablets 25mg

TenofovirAalfenamide( as fumarate)… 25mg
Diary No. Date of R& I & fee Dy No.35096; 23-10-2018: 50,000/- (15-10-15)
Pharmacological Group Nucleotide reverse transcriptase inhibitor (Anti-Viral)
Type of Form Form-5
Finished product Specification Innovator’s Specifications
Pack size & Demanded Price 10’s, 20’s, 30’s ; Rs. 1700/-, 3400/-, 5000/- respectively
Regulatory Authorities. (VEMLIDY tablet 25mg of Gilead Sciences)
Me-too status N/A
GMP status
Drug Tefod Tablets 25mg
Name of Manufacturer M/s Sami Pharmaceuticals (Pvt) Limited. F-95 S.I.T.E. Karachi.
Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co., Ltd, China
API Lot No. Lot #: HCS171610-01 , Quantity; 600g
Description of Pack Alu/AluBlister Pack
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
Date of Initiation 05-01-2018 December 2017 09-02-2018
No. of Batches 03
Date of Submission 31557 (18-09-2018)
Sr. No. Documents To Be Provided Status
1. COA of API. Copy of COA (batch #20170203) from M/s
Zhuhai Rundu Pharmaceutical Co., Ltd, China is
submitted.
2. Approval of API by regulatory authority of Following things have been submitted by the
country of origin or GMP certificate of API firm:
manufacturer issued by regulatory authority of Copy of GMP certificate:
country of origin. Issued To:Yichang HEC Changjiang
pharmaceutical co., Ltd.
Issued by:Yichang Food and Drug
Administration, China.
Validity:up to 15-05-2015
(It is written on this GMP Certificate that
TenofovirAlafenamideFumarate has been
manufactured for export purpose to Korea,
Taiwan, Egypt, Iran, Pakistan, Bangladesh, India,
Vietnam, Algeria, Argentina)
(Lot # of API is not mentioned on Commercial
Invoice)
5. Documents confirming import of API etc. Following things have been submitted by the
firm:
 Copy of Licence to import Drug
(TenofovirAlafenamideFumarate) for
Clinical
Trials/Examination/Test/Analysis dated
06-12-2017.
 Copy of commercial invoice dated 29-11-
2017 stating 600g of
API(TenofovirAlafenamideFumarate)atte
sted by ADC on 06-12-2017, DRAP,
Islamabad

sign and stamp) for ensuring authenticity of data /
documents.
1978.
The panel is requested to report the confirmation by the firm for the following:
1. Confirmation regarding the storage conditions at which the API was kept before manufacturing of batches,
and the facility of cold room for storage of the API during manufacturing of the commercial batches, since
this API is to be stored between 2 to 8oC.
2. Confirmation of dissolution test results for all three Trial Batches (Lab#01, Lab#02, & Lab #03) on US-FDA
Recommended Dissolution Parameters which are Apparatus; Paddle, rpm; 50, Medium; 0.1NHCl, Volume;
900ml & Time; 30 Minutes. Because initially they adopted a different dissolution method by mistake & now
they have performed dissolution test for their product according to US-FDA recommended dissolution
method & found it satisfactory as per their recent information.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Tefod
(TenofovirAlafenamidehemifumarate) 25mg Tablets 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 Tefod (TenofovirAlafenamidehemifumarate) 25mg 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. Confirmation regarding the storage conditions at which the API was kept before manufacturing of
batches, and the facility of cold room for storage of API during manufacturing of commercial batches,
since this API is to be stored between 2°C to 8°C.
2. Confirmation of dissolution test results for all three trial batches on USFDA recommended dissolution
parameters which are Apparatus: Paddle, rpm:50, Medium: 0.1M HCl, Volume: 900ml and Time: 30mins.
Because they initially adopted a different dissolution method by mistake and now they have performed
dissolution test for their product according to USFDA recommended dissolution method & found it
satisfactory as per their recent information
1. Dr. Rafeeq Alam, Meritorious Professor, Department of Pharmacology, University of Karachi, Karachi,
Member Registration Board.
2. Mr.Aslam Shah, Sr. Manager Pharmacy Services, Indus Hospital, Karachi, Member Registration Board.
3. Dr.Affan Ali Qureshi, 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.

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:
S.No. Description Observation by panel

The firm has imported 600.0g
TenofovirAlafenamidehemifumarate raw material
from M/S WIS Pharmatech Co. Ltd. Manufactured
Do you have documents confirming by M/s Yichang HCE Changjian Pharmaceutical
1 the import of API including approval Co. Ltd. China vide invoice no. WIS170115 dated
from DRAP? 29-11-2017 and has obtained approval from DRAP
Karachi.
Batch No. Quantity Imported
HCS171610-01 600.0 g
There is proper vendor evaluation process being
implemented by the firm and the rationale behind
Do you have any rationale behind vendor selection is controlled through:
2
selecting the particular manufacturer
 Desktop Audit checklist
 GMP approval by competent authority
The firm has imported 100mg of working standard
Do you have documents confirming and 10mg impurity standard from, the API
3 the Import of Reference standard and manufacturer China.
Impurities standards?
4 The firm has Certificate of Analysis for API,

Do you have certificate of analysis of
working standards and impurity standard.
the API reference standard and
The firm has provided copy of GMP certificate
Do you have any approval of API or issued by Yichang Food and Drug Administration
GMP certificate of manufacturer
5
issued by regulatory authority of
country of origin?
The firm has used API Manufacturer’s method of

Do you use API manufacturer method
6 testing
of Testing for testing of API?
Do you have stability Studies Report The firm has stability studies report of API
7 on API? TenofovirAlafenamideHemifumarateconducted by
API manufacturer.
If Yes, whether the stability testing has The manufacturer of API has performed the
been performed as per SIM method stability studies of API as per SIM Method and the
8
and degradation products have been Related Substance have been quantified by the API
quantified.? manufacturer
Do you have method for quantifying The firm has methods for quantifying the
9 impurities in API.
the impurities in the API?
The firm has 320g API
Do you have some remaining
TenofovirAlafenamideHemifumaratebut have
10 quantities of the API, Its reference
consumed all working standard and impurity
standard and impurities standard?
standard.
The firm has used pharmaceutical grade excipients.
Have you used pharmaceutical grade Lactose Monohydrate, Microcrystalline cellulose,
11
excipients? Croscarmellose Sodium and Magnesium Stearate.
Sheffcoat has been used for coating.
Do you have documents confirming The firm has documents confirming the import of
12 the used excipients.
the import of the used excipients
Do you have test reports and other The firm has test reports and other records on the
13 excipients.
records on the excipients?
Do you have written and authorized The firm has written and authorized protocol for
14 protocols for the development of the development of Tefod 25mg Tablets.
Tefod 25mg tablets?
Have you performed Drug-Excipient Since firm has used same excipients as used by the
15 compatibility studies? innovator. Therefore, compatibility studies were
not performed.
Have you performed comparative Firm has performed comparative studies with
studies? innovator Vemlidy 25mg tablets manufactured by
16
Gilead Sciences, Inc, Foster City, CA 94404,
Canada.
The firm has product development (R&D) Section
Do you have Product Development / with the facility of manufacturing and Analysis of
17 R&D Section? R&D products.
Do you have necessary equipment’s The firm has necessary equipment available in
available in product development product development section for development
18
section for development of Tefod ofTefod Tablets 25mg.
25mg tablets?
Are the equipment’s in product The available equipment in Product Development
19 are qualified.
development qualified?
Do you have proper maintenance / There is proper maintenance / calibration program
20 calibration / re-qualification program for the 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
development section with proper Product Development Formulation and 6
21
knowledge and training in product Pharmacist and 4 Chemists in Analytical side.
development?
The firm has manufactured three stability batches
Have you manufactured three stability of each 2500 tablets.
batches for the stability studies of Tefod 25mg tablets
Tefod 25mg tablets as required?
Batch No Date of Mfg. Expiry Date
22
Lab-01 01-18 12-19
Lab-02 01-18 12-19
Lab-03 01-18 12-19
Do you have any criteria for fixing the The criteria for fixing the batch size of stability
23 batch size of stability of batches? batches is the number of Tablets per testing
frequencies.
The firm has complete record for the stability
Do you have complete record of batches of Tefod 25mg tablets.
24
Do you have protocols for stability The firm has protocols for testing of stability
25 batches.
testing of stability batches
Do you have developed and validated The firm has developed and validated method of
26 the method for testing of stability testing of finish product Tefod 25mg Tablets, based
batches on method of testing of API.
Do you have method transfer studies Method transfer studies is not applicable as the
in case when the method of testing firm developed 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
the qualification of equipment / qualification of equipment / instruments being used
28 instruments being used in the test and in the test and analysis of the Tefod 25mg tablets.
analysis of the product’s API and
product Tefod 25mg tablets?
Do your method of analysis Stability The firm’s Method of analysis is Stability
29 indicating.
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
Tefod 25mg Tablets testing?
Do you have some remaining The firm has some remaining quantities of stability
32 quantities of degradation products and batches only.
stability batches?
The firm has three stability batches kept on
Do you have batches kept on stability stability for Real time stability testing. 9 Months
33
testing? Real Time and 6 months Accelerated stability
studies has been completed.
Do you have valid calibration status The firm has valid calibration status for the
34 for the equipment’s used in Tefod equipment used in Tefod 25mg tablets production
25mg tablets production and analysis? and analysis.
Do Proper and Continuous monitoring Adequate monitoring and control are available for
35 and control are available for stability stability chamber. Chambers are controlled and
chamber? monitored through software 21CFR compliance.
Do related manufacturing area, Related manufacturing area, equipment, personnel
36 equipment, personnel and utilities be and utilities can be rated as GMP compliant.
Any other query raised by the
Pharmaceutical Evaluation Cell?
3. Confirmation regarding the 3. The firm has cold storage in their product
storage conditions at which the development section as well as in their
API was kept before routine raw material store.
manufacturing of batches, and the
facility of cold room for storage
of API during manufacturing of
37 commercial batches, since this
API is to be stored between 2°C
to 8°C.
4. Confirmation of dissolution test 4. The firm has performed dissolution testing
results for all three trial batches as per USFDA method.
on USFDA recommended
dissolution parameters which are
Apparatus: Paddle, rpm:50,
Medium: 0.1M HCl, Volume:
900ml and Time: 30mins.
Because they initially adopted a
different dissolution method by
mistake and now they have
performed dissolution test for
their product according to
USFDA recommended dissolution
method & found it satisfactory as
per their recent information
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the
firm for registration of Tefod 25mg Tablets (Tenofoviralafenamide) is verifiable to highly
satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are compliant are suited for the
manufacturing of Tefod 25mg Tablets.
Evaluator PEC-XII
Sr. Name & Address of Brand Name Type of Form, International
No. Manufacturer / (Proprietary Name Initial Diary & Date, Availability / Local
Applicant + Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / Pack GMP Inspection Report
Pharmacological size Date & Remarks
Group,
Finished Product
Specification
1226. M/s Highnoon Daplozmet Tablets Form 5-D Ebymect 5 mg/850 mg
Laboratories, 5mg/850mg film-coated tablets by
17.5km, Multan Road, Dairy No. 21945 dated M/s AstraZeneca AB
Lahore. Each film coated 23-11-2017. (EMA approved)
tablet contains: Rs.50,000/- dated 23-11-
Dapagliflozin (as 2017. Last GMP inspection
propanediol dated 06-07-2017; firm is
monohydrate) As per SRO, for 14’s. considered to be
…5mg As per SRO, for 28’s. operating at Good level
Metformin As per SRO, for 56’s. of compliance of GMP
hydrochloride Requirements at the time
…850mg of inspection.
(Combinations of
oral blood glucose
lowering drugs)
Manufacturer’s
Specifications.
Drug Daplozmet Tablets 5mg/850mg
(Dapagliflozin and Metformin hydrochloride)
Name of Manufacturer M/s Highnoon laboratories,
17.5km, Multan Road, Lahore.
Manufacturer of API Dapagliflozin : MSN Laboratories Pvt Ltd, Sy NO. 317 & 323, Rudraram
(Vill), Patancheru (Mandal), Medak District, Telangana, India.
Metformin: Ipca Laboratories Limited, H-4, M.I.D.C, Waluj Industrial
Area, Aurangabad, India.
API Lot No. Dapagliflozin : DQ0010217
Metformin: 17180ML2JMI
Description of Pack Alu/Alu blister
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 24 months
Real Time: 6 months
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Months)
Batch No. RD 18069 RD 18070 RD 18071
Manufacturing Date April 2018 April 2018 April 2018
Date of Initiation April 2018 April 2018 April 2018
No. of Batches 03
Sr. Documents to Be Provided Status
No.
1. COA of API Copy of COA for Dapagliflozin propanediol from
M/s MSN Laboratories Pvt Ltd, India has been
submitted.
Copy of COA for Metformin hydrochloride from
M/s Ipca Laboratories Limited, Aurangabad, India
has been submitted.
2. Approval of API by regulatory authority of Dapagliflozin propanediol: Photocopy of GMP
country of origin or GMP certificate of API Certificate No. 10162/E(R)/TS/2017 for MSN
manufacturer issued by regulatory authority of Laboratories Pvt Ltd, India issued by DCA, Govt. of
country of origin. Telangana is submitted. Valid till 16-10-2019.
Metformin hydrochloride: Photocopy of GMP
Certificate No. NEW-WHO-
GMP/CERT/AD67318/2018/11/24741 for Ipca
Laboratories Limited, Aurangabad, India issued by
FDA, Maharashtra is submitted. Valid till 27-08-
2021.
3. Protocols followed for conduction of stability
Yes
5. Documents confirming import of API etc. Dapagliflozin propanediol: Photocopy of ADC
(Lahore) attested Commercial Invoice containing
batch details of Batch No. DQ0010217 is submitted.
Quantity: 5kg
Metformin hydrochloride: Photocopy of ADC
batch details of Batch No. 17180ML2JMI is
submitted. Quantity: 5000kg
sign and stamp) for ensuring authenticity of Yes
data / documents.
7. Commitment to continue real time stability
Yes
8. Commitment to follow Drug Specification
Yes
Rules, 1978.
Evaluation by PEC:
Decision:
Group,
Finished Product
Specification
1227. M/s Highnoon Daplozmet Tablets Form 5-D Ebymect 5 mg/1000 mg
Laboratories, 5mg/1000mg film-coated tablets by
17.5km, Multan Road, Dairy No. 21946 dated M/s AstraZeneca AB
Lahore. Each film coated 23-11-2017. (EMA approved)
tablet contains: Rs.50,000/- dated 23-11-
Dapagliflozin (as 2017. Last GMP inspection
propanediol dated 06-07-2017; firm is
monohydrate) As per SRO, for 14’s. considered to be
…5mg As per SRO, for 28’s. operating at Good level
Metformin As per SRO, for 56’s. of compliance of GMP
hydrochloride Requirements at the time
…1000mg of inspection.
(Combinations of
oral blood glucose
lowering drugs)
Manufacturer’s
Specifications.
Drug Daplozmet Tablets 5mg/1000mg
(Dapagliflozin and Metformin hydrochloride)
Name of Manufacturer M/s Highnoon laboratories,
Manufacturer of API Dapagliflozin : MSN Laboratories Pvt Ltd, Sy NO. 317 & 323, Rudraram
(Vill), Patancheru (Mandal), Medak District, Telangana, India.
Metformin: Ipca Laboratories Limited, H-4, M.I.D.C, Waluj Industrial
Area, Aurangabad, India.
API Lot No. Dapagliflozin : DQ0010217
Metformin: 17180ML2JMI
Description of Pack Alu/Alu blister
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Batch No. RD 18072 RD 18073 RD 18074
Manufacturing Date April 2018 April 2018 April 2018
Date of Initiation April 2018 April 2018 April 2018
No. of Batches 03
No.
1. COA of API Copy of COA for Dapagliflozin propanediol from
M/s MSN Laboratories Pvt Ltd, India has been
submitted.
Copy of COA for Metformin hydrochloride from
M/s Ipca Laboratories Limited, Aurangabad, India
has been submitted.
2. Approval of API by regulatory authority of Dapagliflozin propanediol: Photocopy of GMP
country of origin or GMP certificate of API Certificate No. 10162/E(R)/TS/2017 for MSN
manufacturer issued by regulatory authority of Laboratories Pvt Ltd, India issued by DCA, Govt. of
country of origin. Telangana is submitted. Valid till 16-10-2019.
Metformin hydrochloride: Photocopy of GMP
Certificate No. NEW-WHO-
GMP/CERT/AD67318/2018/11/24741 for Ipca
Laboratories Limited, Aurangabad, India issued by
FDA, Maharashtra is submitted. Valid till 27-08-
2021.
Yes
5. Documents confirming import of API etc. Dapagliflozin propanediol: Photocopy of ADC
batch details of Batch No. DQ0010217 is submitted.
Quantity: 5kg
Metformin hydrochloride: Photocopy of ADC
batch details of Batch No. 17180ML2JMI is
submitted. Quantity: 5000kg
data / documents.
Yes
Yes
Rules, 1978.
Evaluation by PEC:
Decision:
Report on Investigation of Authenticity / Genuineness of data submitted for registration of
Daplozmet Tablets 5mg/850mg & Daplozmet Tablets 5mg/1000mg by M/s Highnoon Laboratories,
Reference No: 175/2019/FID (VIII) dated 2nd January, 2019.
Investigation Date and Time: 1st January, 2019.
Investigation Site: Factory premises of M/s Highnoon Laboratories, 17.5km, Multan Road, Lahore.
 Mr Asim Rauf (Additional Director, DRAP, Lahore)
 Ms Uzma Barkat (Area Federal Inspector of Drugs, Lahore)
 Mr Shahrukh Ali (Assistant Director, DRAP, Lahore)
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 Inspection
DAPLOZMET TABLETS 5mg/850mg (Dapagliflozin as propanediol monohydrate +
Metformin HCl)
Sr.
Question Observation by the panel
No.
1. Do you have documents confirming the Firm had imported Dapagliflozin propanediol
import of API? from M/s MSN Laboratories, India, and
Metformin HCl from M/s IPCA Laboratories,
India. Invoices for import attested by AD
(I&E) were also seen.
2. What was the rationale behind Firm has a vendor approval system and
selecting the particular manufacturer of according to the firm, the rationale behind
API? selecting the manufacturer is its GMP status
and evaluation as per SOP for vendor
approval. (Firm is using Metformin HCl from
same source in their other products also.)
3. Do you have documents confirming the Firm had Dapagliflozin working standard and
import of reference standard and four impurity standards (obtained from MSN,
impurity standards? India). Reference standards of Metformin
HCl, its two impurities and two related
substances were also procured. Documentary
evidence related to purchase was seen.
4. Do you have certificate of Analysis of Relevant COAs from principal manufacturer
the API, reference standards and were seen.
impurity standards?
5. Do you have any approval of API or Yes, firm had GMP certificate of both API
GMP certificate of API manufacturer manufacturers issued by regulatory authority
issued by regulatory authority of of the country of origin.
country of origin?
6. Do you use API manufacturer method Yes, firm used API manufacturer`s method of
of testing? testing for Dapagliflozin and compendial
method for Metformin HCl..
7. Do you have stability studies reports on Yes, firm had stability studies reports on API
API? as provided by the manufacturer
8. If yes, whether the stability testing has Yes, stability testing had been performed as
been performed as per SIM method and per Stability Indicating Method (SIM) and
degradation products have been impurities/ related substances/degradation
quantified? products had been quantified.
9. Do you have method for quantifying Yes, firm had method for quantifying the
the impurities in the API? impurities in the API. Dapagliflozin
propanediol was tested accordingly.
However, results of impurity and related
substances of Metformin HCl were taken from
manufacturer’s COA.
10. Do you have some remaining quantities Yes, some remaining quantities of the APIs,
of the API, its reference standard and reference standards, impurity standards and
impurities standards? working standards were available.
11. Have you used pharmaceutical grade Yes, firm had used pharmaceutical grade
excipients? excipients.
12. Do you have documents confirming the Yes, firm had necessary documents
import of the used excipients? confirming the import of the excipients used
in product.
13. Do you have test reports and other Yes, the firm had test reports and other record
records on the excipients used? of the excipients used.
14. Do you have written and authorized Yes, the firm had written and authorized
protocols for the development of the protocols for the development of the product. .
product?
15. Have you performed Drug-excipient Yes, firm had performed drug excipient
compatibility studies? compatibility studies and all excipients were
found compatible with the APIs as per the
report provided.
16. Have you performed comparative Yes, firm has performed comparative
dissolution studies? dissolution studies and the product showed
comparable results.
17. Do you have product development Yes, firm had a product development (PD)
(R&D) section? department.
18. Do you have necessary equipments

Yes, firm had necessary equipment available
available in product development
in product development section for
section for development of the development of the product.
product? Remarks: Firm was advised to upgrade PD
laboratory. Firm’s management informed that
revamping and upgradation of the facility is
already under planning.
19. Are the equipments in product The equipment in product development
development section qualified? section were qualified as informed by the
firm. Equipment qualification protocols were
available. Two protocols were randomly
selected and scrutinized.
20. Do you have proper maintenance / Yes, firm had a maintenance / calibration / re-
calibration / re-qualification program qualification program for the whole facility
for the equipment used in PD section? including equipment used in PD section.
21. Do you have qualified staff in product Yes, firm had qualified and trained staff in
development section with proper product development section. Training record
knowledge and training in product was seen for the year 2018.
development?
22. Have you manufactured three stability Firm had manufactured three stability batches
batches for the stability studies of the for the stability studies of Daplozmet Tablets
product as required? 5mg/850mg with Batch No. RD-18069, RD-
18070 & RD-18071 (batch size of 2500
tablets).
23. What was the criteria for fixing the The criteria for fixing the batch size of
batch size of stability batches? stability batches, as informed by the firm, was
based on the quantity required for stability
study (i.e. number of tablets per testing
frequency and number of testing frequencies /
intervals), minimum working capacity of
equipment and DRAP guidelines.
24. Do you have complete record of Yes, firm had complete record of production
production of stability batches? of stability batches.
25. Do you have protocols for stability Yes, firm had protocols for stability testing of
26. Do you have developed and validated Yes, firm had developed method for testing of
the method for testing of stability stability batches. Test method validation
batches? protocol and report for identification, assay
and content uniformity was available.
27. Do you have method transfer studies in The method for testing of the product was
case when the method of testing being developed and validated in the firm’s
used by your firm is given by any other premises.
lab?
28. Do you have documents confirming the Yes, firm had documents confirming the
qualification of equipments / qualification of equipment / instruments being
instruments being used in the test and used in the test and analysis of API and
analysis of API and the finished drug? finished drug product.
29. Is your method of analysis stability Yes, firm’s method of analysis was stability
indicating? indicating and the record of testing of stability
batches was available.
30. Is your HPLC software 21CFR Audit trail was active on all HPLC systems
compliant? used in the method validation and stability
study. Individual user log in and IDs were
available.
31. Can you show Audit Trail reports on Audit trail reports were available and
product testing? randomly checked.
32. Do you have some remaining quantities The firm has remaining quantities of some
of degradation products and stability impurity standards and stability batches.
batches?
33. Do you have stability batches kept on The stability studies of trial batches kept at
stability testing? 30˚C/65% RH were on going.
34. Do you have valid calibration status for
Firm had valid calibration status for the
the equipments used in production and equipment used in production and analysis of
analysis? the product.
35. Is proper and continuous monitoring Yes, monitoring and control was available for
and control available for stability the stability chambers provided.
chamber? Firm was advised to install alarm system in
stability chamber and perform challenge test.
36. Can related manufacturing area, The related facilities of Highnoon
equipment, personnel and utilities be Laboratories Ltd., Lahore were GMP
rated as GMP compliant? compliant.
DAPLOZMET TABLETS 5mg/1000mg (Dapagliflozin as propanediol monohydrate + Metformin
HCl)
Sr.
No.
1. Do you have documents confirming the Firm had imported Dapagliflozin propanediol
import of API? from M/s MSN Laboratories, India, and
Metformin HCl from M/s IPCA Laboratories,
India. Invoices for import attested by AD
(I&E) were also seen.
2. What was the rationale behind selecting Firm has a vendor approval system and
the particular manufacturer of API? according to the firm, the rationale behind
selecting the manufacturer is its GMP status
and evaluation as per SOP for vendor
approval. (Firm is using Metformin HCl from
same source in their other products also.)
3. Do you have documents confirming the Firm had Dapagliflozin working standard and
import of reference standard and four impurity standards (obtained from MSN,
impurity standards? India). Reference standards of Metformin
HCl, its two impurities and two related
substances were also procured. Documentary
evidence related to purchase was seen.
4 Do you have certificate of Analysis of Relevant COAs from principal manufacturer
impurity standards?
5 Do you have any approval of API or Yes, firm had GMP certificate of both API
issued by regulatory authority of country of the country of origin.
of origin?
6 Do you use API manufacturer method of Firm used API manufacturer`s method of
testing? testing for Dapagliflozin and compendial
method for Metformin HCl.
7 Do you have stability studies reports on Yes, firm had stability studies reports on API
API? as provided by the manufacturer
8 If yes, whether the stability testing has Yes, stability testing had been performed as
been performed as per SIM method and per Stability Indicating Method (SIM) and
degradation products have been impurities/ related substances/degradation
quantified? products had been quantified.
9 Do you have method for quantifying the Yes, firm had method for quantifying the
impurities in the API? impurities in the API. Dapagliflozin
propanediol was tested accordingly.
However, results of impurity and related
substances of Metformin HCl were taken from
manufacturer’s COA.
10 Do you have some remaining quantities Yes, some remaining quantities of the APIs,
of the API, its reference standard and reference standards, impurity standards and
impurities standards? working standards were available.
11 Have you used pharmaceutical grade Yes, firm had used pharmaceutical grade
12 Do you have documents confirming the Yes, firm had necessary documents
in product.
13 Do you have test reports and other Yes, the firm had test reports and other record
14 Do you have written and authorized Yes, the firm had written and authorized
protocols for the development of the protocols for the development of the product. .
product?
15 Have you performed Drug-excipient Yes, firm had performed drug excipient
compatibility studies? compatibility studies and all excipients were
report provided.
16 Have you performed comparative Yes, firm has performed comparative
dissolution studies? dissolution studies and the product showed
comparable results.
17 Do you have product development Yes, firm had a product development (PD)
(R&D) section? department.
18 Do you have necessary equipments Yes, firm had necessary equipment available
available in product development section in product development section for
for development of the product? development of the product.
Remarks: Firm was advised to upgrade PD
19 Are the equipments in product The equipment in product development
development section qualified? section were qualified as informed by the
firm. Equipment qualification protocols were
available. Two protocols were randomly
selected and scrutinized.
20 Do you have proper maintenance / Yes, firm had a maintenance / calibration / re-
calibration / re-qualification program for qualification program for the whole facility
the equipment used in PD section? including equipment used in PD section.
21 Do you have qualified staff in product Yes, firm had qualified and trained staff in
knowledge and training in product was seen for the year 2018.
development?
22 Have you manufactured three stability Firm had manufactured three stability batches
batches for the stability studies of the for the stability studies of Daplozmet Tablets
product as required? 5mg/1000mg with Batch No. RD-18072, RD-
18073 & RD-18074 (batch size of 2500
tablets).
23 What was the criteria for fixing the batch The criteria for fixing the batch size of
size of stability batches? stability batches, as informed by the firm, was
based on the quantity required for stability
study (i.e. number of tablets per testing
frequency and number of testing frequencies /
intervals), minimum working capacity of
equipment and DRAP guidelines.
24 Do you have complete record of Yes, firm had complete record of production
25 Do you have protocols for stability Yes, firm had protocols for stability testing of
26 Do you have developed and validated the Yes, firm had developed method used for
method for testing of stability batches? testing of stability batches. Test method
validation protocol and report for
identification, assay and content uniformity
was available.
27 Do you have method transfer studies in The method for testing of the product was
case when the method of testing being developed and validated in the firm’s
used by your firm is given by any other premises.
lab?
28 Do you have documents confirming the Yes, firm had documents confirming the
qualification of equipments / instruments qualification of equipment / instruments being
being used in the test and analysis of API used in the test and analysis of API and
and the finished drug? finished drug product.
29 Is your method of analysis stability Yes, firm’s method of analysis was stability
30 Is your HPLC software 21CFR Audit trail was active on all HPLC systems
compliant? used in the method validation and stability
study. Individual user log in and IDs were
available.
31 Can you show Audit Trail reports on Audit trail reports were available and
product testing? randomly checked.
32 Do you have some remaining quantities The firm has remaining quantities of some
batches?
33 Do you have stability batches kept on The stability studies of trial batches kept at
34 Do you have valid calibration status for
Firm had valid calibration status for the
the equipments used in production and equipment used in production and analysis of
analysis? the product.
35 Is proper and continuous monitoring and
Yes, monitoring and control was available for
control available for stability chamber?
the stability chambers provided.
Firm was advised to install alarm system in
36 Can related manufacturing area, The related facilities of Highnoon
equipment, personnel and utilities be Laboratories Ltd., Lahore were GMP
Conclusion:
Based on the documents reviewed, areas inspected and technical personnel met, and considering
the findings of the inspection, the panel is of the view that stability studies were conducted by the
firm M/s Highnoon Laboratories Ltd., 17.5 km Multan Road, Lahore, and relevant data of the
products Daplozmet Tablets 5mg/850mg and Daplozmet Tablets 5mg/1000mg (Dapagliflozin as
propanediol monohydrate + Metformin HCl) provided by the firm was verified.
Decision:
Evaluator PEC-XII
Group,
Finished Product
Specification
1228. M/s Bosch Dovir Tablets Form 5-D DAKLINZA daclatasvir
Pharmaceuticals (Pvt) 30mg tablets by M/s Gilead
Limited, Dairy No. 2847, Dated Sciences, Inc (USFDA
Bosch House, 221, Each film coated 15-12-2016. approved)
Sector 23, Korangi tablet contains: Rs.50,000/-, Dated 15-
Industrial Area, Karachi. Daclatasvir (as 12-2016. 21-09-2017 GMP and
dihydrochloride) follow up inspection Firm
…… 30mg 28’s/ As per PRC is operating at acceptable
level of GMP
Direct Acting compliance.
Antivirals
(Antivirals for
treatment of HCV
infections)
Manufacturer’s
Specifications.
Drug Dovir Tablets 30mg (Daclatasvir)
Name of Manufacturer M/s Bosch Pharmaceuticals (Pvt) Limited,
Bosch House, 221, Sector 23, Korangi Industrial Area, Karachi.
Manufacturer of API M/s Optimus Drugs Private Limited,
Survey No. 239 & 240 Dothigudem (V), Pochampally (M), Nalgonda (D),
508284, Telangana, India.
API Lot No. DP-850-S3-006/16
Description of Pack Alu/ alu blister packing.
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Batch No. TR-DV-02 TR-DV-03 TR-DV-04
Manufacturing Date Nov 2017 Nov 2017 Nov 2017
No. of Batches 03
No.
1. COA of API Copy of COA for Daclatasvir (as dihydrochloride)
from M/s Optimus Drugs Private Limited,
Telangana, India. Has been submitted.
2. Approval of API by regulatory authority of Firm has submitted copy of the document ‘List of
country of origin or GMP certificate of API products approved under WHO GMP Certification
manufacturer issued by regulatory authority of Scehme for Export purpose’ issued by DCA
country of origin. Yelangana. Which states the name of Daclatasvir
hydrochloride.
Document confirms that the firm is GMP compliant.
Document is valid till 03-01-2018
Yes
5. Documents confirming import of API etc. Firm has submitted copy of receipt of Daclatasvir.
Firm has imported Daclatasvir from M/s. Optimus
drugs (Pvt.) Ltd via FedEx. Batch number: DP-850-
S3-006/16 and Quantity: 500gms.
Firm has submitted copy of from 6 attested by ADC
Karachi confirming import of API..
data / documents.
Yes
Yes
Rules, 1978.

Group,
Finished Product
Specification
1229. M/s Bosch Dovir Tablets Form 5-D DAKLINZA daclatasvir
Pharmaceuticals (Pvt) 60mg tablets by M/s Gilead
Limited, Dairy No. 2850, Dated Sciences, Inc (USFDA
Bosch House, 221, Each film coated 15-12-2016. approved)
Sector 23, Korangi tablet contains: Rs.50,000/-, Dated 15-
Industrial Area, Karachi. Daclatasvir (as 12-2016. 21-09-2017 GMP and
dihydrochloride) follow up inspection Firm
…… 60mg 28’s/ As per PRC is operating at acceptable
level of GMP
Direct Acting compliance.
Antivirals
(Antivirals for
treatment of HCV
infections)
Manufacturer’s
Specifications.
Drug Dovir Tablets 60mg (Daclatasvir)
Name of Manufacturer M/s Bosch Pharmaceuticals (Pvt) Limited,
Bosch House, 221, Sector 23, Korangi Industrial Area, Karachi.
Manufacturer of API M/s Optimus Drugs Private Limited,
Survey No. 239 & 240 Dothigudem (V), Pochampally (M), Nalgonda (D),
508284, Telangana, India.
API Lot No. DP-850-S3-006/16
Description of Pack Alu/ alu blister packing.
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Batch No. TR-DV-05 TR-DV-06 TR-DV-07
Manufacturing Date Nov 2017 Nov 2017 Nov 2017
No. of Batches 03
No.
1. COA of API Status
2. Approval of API by regulatory authority of

Copy of COA for Daclatasvir (as dihydrochloride)
from M/s Optimus Drugs Private Limited,
Telangana, India. Has been submitted.
country of origin.
3. Protocols followed for conduction of stability Firm has submitted copy of the document ‘List of
study and details of tests. products approved under WHO GMP Certification
Scehme for Export purpose’ issued by DCA
Yelangana. Which states the name of Daclatasvir
hydrochloride.
Document confirms that the firm is GMP compliant.
Document is valid till 03-01-2018
6. All provided documents will be attested (name, Firm has submitted copy of receipt of Daclatasvir.
sign and stamp) for ensuring authenticity of Firm has imported Daclatasvir from M/s. Optimus
data / documents. drugs (Pvt.) Ltd via FedEx. Batch number: DP-850-
S3-006/16 and Quantity: 500gms.
Firm has submitted copy of from 6 attested by ADC
Karachi confirming import of API..
Yes
Yes
Rules, 1978.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Dovir

30mg & 60mg Tablets (Daclatasvir) Tablets by M/s. Bosch Pharmaceuticals, Korangi Industrial Area,
Karachi.
Reference No: F.13-11/2017-PEC(Pt) dated 10th, December, 2018.

Investigation Date and Time: 25th January, 2019 (Afternoon).
Investigation Site: Factory premises of M/s. Bosch Pharmaceuticals, Korangi
Industrial Area, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Bosch Pharmaceutical, Bosch
House 221, Sector 23, Korangi Industrial Area, Karachi for registration of Dovir 30mg & 60mg
(Daclatasvir) 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.
7. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women, Karachi. (Member
Registration Board)
8. Dr. Najam us Saquib, Federal Inspector of Drugs, DRAP, Karachi.
9. Dr. Saif ur Rehman Khattak, Director, CDL, 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 summarized as under::
Details of Inspection
DOVIR 30MG & 60MG TABLETS
S.No. Question Observation by panel
1 Do you have documents confirming the The firm has imported 0.5Kg Daclatasvir
import of API ? Batch no: DP-850-S3-006-16 from M/s
Optimus Drug Pvt Ltd India and has taken
approval from DRAP-Karachi for import
2 What was the rationale behind selecting There is proper vendor qualification being
the 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
import of API reference standard and of API of said batches working standards and
impurity standards? their impurities standards.
4 Do you have certificate of Analysis of the The firm has certificates of analysis for both
API, reference standards and impurity APIs, working standards and their impurities.
standards?
5 Do you have any approval of API or The firm has GMP certificate of the
GMP certificate of API manufacturer manufacturer issued by Drug Control
issued by regulatory authority of country Administration, Govt of Telangana, India
of origin?
6 Do you use API manufacturer method of The firm has used API manufacturer method of
testing? testing for both APIs.
7 Do you have stability studies reports on The firm has stability studies reports on API.
API?
8 If yes, whether the stability testing has The stability testing has been performed as per
been performed as per SIM method and SIM method and degradation products have
degradation products have been been quantified.
quantified?
9 Do you have method for quantifying the The firm has method for quantifying the
impurities in the API? impurities in the API.
10 Do you have some remaining quantities The firm has remaining quantities of API,
of the API, its reference standard and reference standard and impurity standards.
11 Have you used pharmaceutical grade The firm has used pharmaceutical grade
12 Do you have documents confirming the The firm has documents confirming the import
import of the used excipients? of all excipients used.
13 Do you have test reports and other The firm has test reports and other records on
records on the excipients used? the excipients used.
14 Do you have written and authorized The firm has written and authorized protocols
protocols for the development of API for the development of Dovir (Daclatasvir)
tablets? 30mg & 60mg tablets.
15 Have you performed Drug-excipient Drug-excipients compatibility studies were not

compatibility studies? performed as the firm has used the same
excipients as of innovator.
16 Have you performed comparative The firm has performed comparative

dissolution studies? dissolution studies and their product has shown
comparable dissolution profile.
17 Do you have product development The firm has product development (R&D)
(R&D) section section with equipment for manufacturing of
tablet dosage form and analytical lab for test/
analysis of R&D and stability batches.
18 Do you have necessary equipment The firm has necessary equipment for product
available in product development section development of Dovir tablets.
for development of API tablets?
19 Are the equipment in product The available equipment in product
development section qualified? development section are qualified.
20 Do you have proper maintenance / The firm has SOP for the
calibration / re-qualification program for maintenance/calibration/requalification of
the equipment used in PD section? equipment used on PD section.
21 Do you have qualified staff in product The firm has qualified staff in product
development section with proper development section with relevant work
knowledge and training in product experience.
development?
22 Have you manufactured three stability The firm has manufactured three consecutive
batches for the stability studies of API stability batches for the accelerated and real
tablets as required? time stability studies of Dovir tablet
Dovir Tablet 30mg ( TR-DV-02 , TR-DV-03 ,
TR-DV-04 )
Dovir Tablet 60mg ( TR-DV-05 , TR-DV-06 ,
TR-DV-07 )
23 What was the criteria for fixing the batch The criteria for fixing the batch size of stability
size of stability batches? batches is the number of tablets per testing and
the number of tablets required for whole
stability testing.
24 Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches. Necessary log books of
equipment used has been available with the
firm.
25 Do you have protocols for stability The firm has detailed protocol for stability
testing of stability batches? testing of stability batches.
26 Do you have developed and validated the The firm has developed and validated their
method for testing of stability batches? own method for testing of stability batches.
The method is supported by impurities

standards spiking studies and forced
degradation, hence capable of quantifying the
degradation products in their tablets kept on
stability testing.
27 Do you have method transfer studies in Not Applicable

case when the method of testing being
lab?
28 Do you have documents confirming the The firm has proper documents confirming the
qualification of equipment / instruments qualification of equipment / instruments being
and the finished drug? finished drug.
29 Do your method of analysis stability The firm’s method of analytical testing has
indicating? stability indicating parameters.
30 Do your HPLC software is 21CFR The HPLC software is 21CFR Compliant as
compliant? per record available with the firm.
31 Can you show Audit Trail reports on API The firm showed the audit trail reports on API
testing? testing.
32 Do you have some remaining quantities The firm has remaining quantities of stability
of degradation products and stability batches.
batches?
33 Do you have commitment batches kept The firm has completed accelerated stability
on stability testing? testing on the three stability batches of both
strengths. The real time stability testing is in
progress on all the three stability batches.
34 Do you have valid calibration status for The firm has valid calibration status for the
the equipment used in API tablets equipment used in Dovir tablets production and
production in analysis? analysis.
35 Do proper and continuous monitoring Continuous power supply and monitoring are
and control are available for stability available for stability chambers.
chamber?
36 Do related manufacturing area, The related manufacturing area, equipment,
equipment, personnel and utilities be personnel and utilities be rated as GMP
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability
data submitted by the firm for registration of Dovir 30mg & 60mg (Daclatasvir)
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 Dovir 30mg & 60mg Tablets.
Recommendations:
1. The firm may kindly be granted necessary registration of Dovir 30mg & 60mg tablets.
Decision:
Evaluator PEC-XIV
No of Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision /
Applicant Dosage Form + Date, Fee Local Remarks
1230. M/s Highnoon Nebvax 5/80 mg Form 5D Byvalson of M/s The firm has
Laboratories Tablet Dy. No.21689 Allergan sales, claimed
limited. 17.5 Each film coated 21-06-2018 USFDA Manufacturer’s
Kilometer, Multan tablet contains: Rs.50,000/-, Specifications.
Road, Lahore Nebivolol as N/A
Hydrochloride…….... (Duplicate
.5mg Dossier) Last GMP
Valsartan ……80mg inspection
Anti-Hypertensive 14’s, 30’s, 60’s; dated 06-07-
As per SRO 2017; firm is
(Manufacturers considered to
specifications)
be operating at
Good level of
compliance of
GMP
requirements at
the time of
inspection.
Drug Nebvax 5/80 mg Tablet
Name of Manufacturer M/S Highnoon Laboratories limited
Manufacturer of API Valsartan: M/s. Zhejiang Tianyu Pharmaceuticals Co. Ltd. China
Nebivolol HCl: M/s. Cadila Pharmaceuticals Ltd, 294, G.I.D.C, Estate
Ankleshawar- 3293002, Gujrat India
API Lot No. Valsartan: 10230-161204
Valsartan: 10230-161117
Valsartan: 10230-161116
Nebivolol HCl: 17NV011
Description of Pack Alu/Alu Blister in outer unit carton
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 09 Months
Real Time: 0,3,6,9 (Months)
Batch No. RD 17091 RD 17092 RD 17093
Manufacturing Date August-2017 August-2017 August-2017
Date of Initiation September-2017 September-2017 September-2017
No. of Batches 3
1. COA of API Valsartan: Copy of COA from M/s Zhejiang Tiianyu
Pharmaceuticals, China is submitted
Nebivolol HCl: Copy of COA from M/s Cadila
Pharmaceuticals Ltd, India is submitted.
2. Approval of API by regulatory authority of Valsartan: Copy of GMP of M/s Zhejiang Tianyu
country of origin or GMP certificate of API Pharmaceuticals, China (Certificate No.
manufacturer issued by regulatory authority ZJ20130111) issued by State Food and Drug
of country of origin. Administration has been submitted.
Nebivolol HCl: Copy of GMP of M/s Cadila
Pharmaceuticals Certificate No.16061158 6078745
issued by Food & Drug control Adminstration,
Gujarat Estate. India is submitted
sheets etc.
5. Documents confirming import of API etc. Valsartan: Copy of ADC (Lahore) attested dated: 27-
04-2017 Commercial Invoice No TY117257 Dated: 17-
05-2017 issued by M/s Zhejiang Tianyu
Pharmaceuticals is submitted.
Nebivolol HCl: Copy of ADC (Lahore) attested dated:
16-06-2017 Commercial Invoice No CPL/BD/123/17-
18 Dated: 14-06-2017 issued by M/s Cadila
Pharmaceuticals Ltd is submitted.
Rules, 1978.
REMARKS OF EVALUATOR(VI)
● The firm has provided 06 Months Accelerated and 09 Months Real Time Stability Data for 03 Batches.
● The firm has procured Valsartan from M/s Zhejiang Tianyu Pharmaceuticals, China.
● EMA has updated on medicines containing valsartan from Zhejiang Tianyu, China.
“Company no longer authorised to manufacture valsartan active substance for EU medicines due to
presence of NDMA”.
https://www.ema.europa.eu/documents/press-release/update-medicines-containing-valsartan-zhejiang-
tianyu_en.pdf
Previous Decision: Registration Board deferred the case for impurity profiling for identification of
NDMA levels in the procured valsartan from Zhejiang Tianyu, China. (M-285)
● The firm has submitted calculation comparison for maximum level of NDMA in finished product
Nebvax 5/80mg tablet as well as FDA acceptable intake limit by consuming finished products as shown
in table below;
Calculations for Maximum Level of NDMA in finished product Nebvax 5/80mg Tablet
NDMA in Valsartan (API)
Provisional Acceptable Limit of NDMA in API 0.3ppm or 0.3 µg/g or 0.3 nanogram/mg
(Valsartan) 1ppm = 1 µg/g = 1 nanogram /mg
Max NDMA in Valsartan from API NMT 0.3 ppm
Manufacturer Zhejiang Tianyu Pharmaceutical (NMT 0.3 ppm or 0.3 µg/ g or 0.3
Co. Ltd., China nanogram/mg)
FDA acceptable intake Limit of NDMA by 0.096 µg/Day or 96 nanogram/day
consuming Finished products
Quantity of Valsartan in Nebvax 5/80mg Tablet 80mg /Tablet
Maximum daily dose of Nebvax 5/80mg Tablet 1 Tablet / Day
Daily intake of Valsartan by consuming 80mg / Day
maximum dose of Nebvax 5/80mg Tablet
Maximum Qty of NDMA in Valsartan as 1 Tablet / Day
confirmed by API manufacturer
Maximum daily intake of NDMA by consuming 80 mg × 0.3 nanogram/mg = 24 nanogram
Nebvax 5/80mg Tablets
Conclusion Per day quantity of NDMA in Nebvax tablet is
1/4th of FDA acceptable limit.
●
INSPECTION REPORT OF HIGHNOON LABORATORIES LTD, LAHORE
General Information
Name of Manufacturer M/s Highnoon Laboratories Ltd.
Physical Address 17.5 km Multan Road, Lahore
DML No. and Validity DML by way of formulation. No. 00155

Date of renewal: 20-08-2015
Date of Inspection 1st January, 2019
Purpose of Inspection Panel inspection for verification of authenticity of stability

data for purpose of registration of drugs with reference to
DRAP Islamabad letter No. F.13-11/2017-PEC (Pt) dated
14th December, 2018
Name of Inspectors Mr Asim Rauf (Additional Director, DRAP, Lahore)
Ms Uzma Barkat (Area Federal Inspector of Drugs, Lahore)
Mr Shahrukh Ali (Assistant Director, DRAP, Lahore)
Name of firm representatives Dr Saleem Akhter (Director, Quality Operations)
accompanying during Ms Azia Zafar (Head of Quality Control & Validation)
inspection Ms Irum Naila (Head of Regulatory Affairs)
Ms Noureen Afzal (Head of Product Development)
Dr Muhammad Saqlain Tahir (Head of Quality Assurance)
Mr Shahid Rashid (Head of Compliance & Audit)
Mr Muhammad Asif (Manager Quality Control)
Mr Fahd Ali (Manager Stability)
Focus of Inspection
The inspection of M/s Highnoon Laboratories Ltd., Lahore was conducted with reference to DRAP
Islamabad letter no. F.13-11/2017-PEC (Pt) dated 14th December, 2018, for verification of
authenticity of stability data of product namely Nebvax Tablets 5mg/80mg. The panel evaluated the
relevant documentation and also visited the production area, product development laboratory and
quality control laboratory of the company.
The data of was evaluated in accordance with the checklist provided as given below.
Details of Investigation
NEBVAX TABLETS 5/80mg (Nebivolol as HCl + Valsartan)
Sr.
No.
1. Do you have documents confirming the Firm had imported Nebivolol HCl from M/s
import of API? Cadila Pharmaceutical, India and Valsartan from
M/s Zhejiang Tianyu Pharmaceutical, China.
Invoices for import attested by AD (I&E) were
also seen.
2. What was the rationale behind selecting the Firm has a vendor approval system and according
particular manufacturer of API? to the firm, the rationale behind selecting the
manufacturer is its GMP status and evaluation as
per SOP for vendor approval. (Firm was using
Nebivolol HCl and Valsartan from same sources in
their other products also.)
3. Do you have documents confirming the Documentary evidence related to purchase of
import of reference standard and impurity reference standard was available. Impurity
standards? standards were not procured yet.
4. Do you have certificate of Analysis of the Relevant COAs from principal manufacturer were
API, reference standards and impurity seen.
standards?
5. Do you have any approval of API or GMP Yes, firm had GMP certificate of both API
certificate of API manufacturer issued by manufacturers issued by regulatory authority of
regulatory authority of country of origin? their respective country of origin.
6. Do you use API manufacturer method of Yes, firm used API manufacturer`s method of
testing? testing for Nebivolol HCl and compendial method
for Valsartan.
7. Do you have stability studies reports on Yes, firm had stability studies reports on API as
API? provided by the manufacturer
8. If yes, whether the stability testing has been Yes, stability testing had been performed as per
performed as per SIM method and Stability Indicating Method (SIM) and impurities/
degradation products have been quantified? related substances/degradation products had been
quantified.
9. Do you have method for quantifying the Yes, firm had method for quantifying the
impurities in the API? impurities in the API.
However, firm had taken specific results of related
substances A, B and C of Valsartan from
manufacturer’s COA. Firm had performed test for
assessing individual and total percentage of related
substances by area normalization method and
results were found to be within limits prescribed in
USP.
Impurities in Nebivolol HCl were assessed by
using relative retention time given by the API
manufacturer.
The firm informed that clarification for N-NDMA
presence in Valsartan from the said source had
been submitted to the concerned division by the
firm and had been evaluated by concerned division
as given in summary of case provided by PE&R
Division alongwith the inspection letter No. F.13-
11/2017-PEC (Pt) dated 14th December, 2018.
10. Do you have some remaining quantities of Yes, APIs were available however, no remaining
the API, its reference standard and impurities quantities of reference standards were available.
standards?
12. Do you have documents confirming the Yes, firm had necessary documents confirming the
import of the used excipients? import of the excipients used in product.
13. Do you have test reports and other records Yes, the firm had test reports and other record of
on the excipients used? the excipients used.
14. Do you have written and authorized Yes, the firm had written and authorized protocols
protocols for the development of the for the development of the product.
product?
15. Have you performed Drug-excipient Yes, firm had performed drug excipient
compatibility studies? compatibility studies and all excipients were found
compatible with the APIs as per the report
provided.
16. Have you performed comparative dissolution Yes, firm has performed comparative dissolution
studies? studies and the product showed comparable
results.
17. Do you have product development (R&D) Yes, firm had a product development (PD)
section? department.
18. Do you have necessary equipments available Yes, firm had necessary equipment available in
in product development section for product development section for development of
development of the product? the product.
Remarks: Firm was advised to upgrade PD
19. Are the equipments in product development The equipment in product development section
section qualified? were qualified as informed by the firm. Equipment
qualification protocols were available. Two
protocols were randomly selected and scrutinized.
20. Do you have proper maintenance / Yes, firm had a maintenance / calibration / re-
calibration / re-qualification program for the qualification program for the whole facility
equipment used in PD section? including equipment used in PD section.
21. Do you have qualified staff in product Yes, firm had qualified and trained staff in product
development section with proper knowledge development section. Training record was seen for
and training in product development? the year 2018.
22. Have you manufactured three stability Firm had manufactured three stability batches for
batches for the stability studies of the the stability studies of Nebvax Tablets 5mg/80mg
product as required? with Batch No. RD-17091, RD-17092 & RD-
17093 (batch size of 4000 tablets).
23. What was the criteria for fixing the batch The criteria for fixing the batch size of stability
size of stability batches? batches, as informed by the firm, was based on the
quantity required for stability study (i.e. number of
tablets per testing frequency and number of testing
frequencies / intervals), minimum working
capacity of equipment and DRAP guidelines.
24. Do you have complete record of production Yes, firm had complete record of production of
of stability batches? stability batches.
25. Do you have protocols for stability testing of Yes, firm had protocols for stability testing of
stability batches? stability batches.
26. Do you have developed and validated the Yes, firm had developed method for testing of
method for testing of stability batches? stability batches. Test method validation protocol
and report for identification, assay and content
uniformity was available.
27. Do you have method transfer studies in case The method for testing of the product was
when the method of testing being used by developed and validated in the firm’s premises.
your firm is given by any other lab?
being used in the test and analysis of API used in the test and analysis of API and finished
and the finished drug? drug product.
29. Is your method of analysis stability Yes, firm’s method of analysis was stability
30. Is your HPLC software 21CFR compliant? Audit trail was active on all HPLC systems used in
the method validation and stability study.
Individual user log in and IDs were available.
31. Can you show Audit Trail reports on product Audit trail reports were available and randomly
testing? checked.
32. Do you have some remaining quantities of The firm had remaining quantities of stability
degradation products and stability batches? batches.
34. Do you have valid calibration status for the Firm had valid calibration status for the equipment
equipments used in production and analysis? used in production and analysis of the product.
35. Is proper and continuous monitoring and Yes, monitoring and control was available for the
control available for stability chamber? stability chambers provided.
36. Can related manufacturing area, equipment, The related facilities of Highnoon Laboratories
personnel and utilities be rated as GMP Ltd., Lahore were GMP compliant.
compliant?
CONCLUSION
Based on the documents reviewed, areas inspected and technical personnel met, and considering the
findings of the inspection, the panel is of the view that stability studies were conducted by the firm
M/s Highnoon Laboratories Ltd., 17.5 km Multan Road, Lahore, and relevant data of the product
Nebvax Tablets 5mg/80mg (Nebivolol as Hydrochloride + Valsartan) provided by the firm was
verified.
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Availability
Group, / Pack size
Finished Product
Specification
1. M/s Pacific Zaniprill Tablets Form 5-D Zaneril Tablets by Recordati
Pharmaceuticals Ltd., 10/10mg 13-5-2016 Pharmaceuticals (MHRA
30 Km Multan Road, Each film coated PKR 50,000/- Approved)
Lahore, Pakistan. tablet contains: (DUPLICATE)
Enalapril 1x10’s 13-4-2017: Panel recommends
maleate….10mg (As per SRO) renewal of DML
Lercanidipine
HCl….10mg
(ACE Inhibitor/CCB)
Remarks of Evaluator:
The firm has submitted stability study data along with required documents as per checklist approved in 251st
meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 2566 dated 19-1-2018)
Drug Zaniprill Tablets 10/10mg
Name of Manufacturer M/s Pacific Pharmaceuticals Ltd., 30 Km Multan Road, Lahore,
Pakistan.
Manufacturer of API Enalapril Maleate: Zhejiang Huahai Pharmaceutical Co. Ltd., China
Recordati Industria Chimica E Farmaceutica S.p.A.
Lercanidipine
Mfg site: Campoverde Via Mediana Cisterna, 4
hydrochloride:
04011 Campoverde Di Aprilia, Italy.
API Lot No. Enalapril Maleate: 5112-17-059
Lercanidipine
17100694
hydrochloride:
Description of Pack
Opaque PVDC blisters sealed with aluminium foil
Time Period Real time: 26 weeks
Accelerated: 26 weeks
Frequency Accelerated: 0,1,2,3,4,6,8,10,12,16,20,24,26 (Weeks)
Real Time: 0,1,2,3,4,6,8,10,12,16,20,24,26 (Weeks)
Batch No. T0106M T0206M T0306M
Batch Size 10,000 Tablet 10,000 Tablet 10,000 Tablet
Manufacturing Date June-2017 June-2017 June-2017
No. of Batches 03
Date of Submission Dy.# 24476 dated 14-12-2017
# Documents To Be Provided Status
1. COA of API
Yes
2. Approval of API by regulatory authority of Enalapril Maleate: Copy of GMP certificate issued
country of origin or GMP certificate of API by State Food & Drug Administration, China valid
manufacturer issued by regulatory authority of upto 25-09-2019 has been submitted for Enalapril.
country of origin. Lercanidipine hydrochloride: Firm has submitted
copy of Eudra GMP certificate based on inspection
conducted on 16-9-2016. The certificate has been
verified online from Eudra GMP database.
Yes
4. Data of 03 batches will be supported by
Yes
etc.
5. Documents confirming import of API etc. Enalapril Maleate: Firm has submitted invoice of
Gudia (Pvt) Ltd stating that their vendor has brought
the substance from China and have not submitted
any ADC attested invoice.
Lercanidipine hydrochloride: Firm has submitted
ADC attested commercial invoice dated 12-02-2016,
confirming import of API (micronized) 5Kg.
data / documents.
Yes
Yes
Rules, 1978.
 Firm has initially submitted ADC attested invoice for import of Lercanidipine hydrochloride dated 30-3-
2018, later the firm has submitted another invoice of Lercenadipine hydrochloride which was cleared on
12-02-2016. Panel may be requested to verify the exact batch of API used from the dispensing and
quality control log books.
 Firm has manufactured the stability batches in June 2017 and the stability studies were initiated in
February 2018. The Panel may verify the exact temperature and humidity conditions at which the batches
were kept during this time period before initiation of stability studies.
 Firm has initially submitted invoice of Gudia (Private) Limited Ref No. ZHP/008/2017 dated 3 rd June
2017 confirming import of 500g enalapril maleate Batch No. 5112-17-059 and 100mg working standard
Batch No. 2014-199 through DHL. Upon clarification of DHL invoice without ADC clearance and
provision of tracking number of DHL, the firm submitted that their supplier took the material from
principal in their China visit. The firm submitted another copy of invoice of Gudia (Private) Limited with
same details of batch number and quantity but without any reference number, date and with different
signatures. The panel may be requested to verify the details of the import of enalapril maleate including
batch number of the imported API along with exact date of import.
 Firm has used different dissolution media for both API as per the following details:
API Specifications provided by the firm USP specification
Enalapril Apparatus: Paddle Apparatus: Paddle
maleate Speed: 50rpm Speed: 50rpm
Medium: RO Water Medium: pH 6.8 phosphate buffer
Volume: 900ml Volume: 900ml
Time: 30 mins Time: 30 mins
Acceptance criteria: NLT 70% in 30 min Acceptance criteria: NLT 80% (Q) of
labelled amount of C20H28N2O5 · C4H4O4 in
30 min
Lercanidipi Apparatus: Paddle Not available in any official pharmacopoeia
ne Speed: 50rpm
hydrochlori Medium: 0.3% w/v polysorbate 80 in 0.1N
de HCl (freshly prepared)
Volume: 900ml
Time: 45 mins
Acceptance criteria: NLT 70% in 45 min
 While the USP general chapter <1092> The Dissolution Procedure: Development and Validation states
that “Purified water is often used as the dissolution medium, but is not ideal for several reasons. First, the
quality of water can vary depending on the source of the water, and the pH value of the water is not
controlled. Second, the pH value can vary from day to day and can also change during the run,
depending on the active substance and excipients”. Further it recommends that solubility of the drug
along with profiling of drug release in the dissolution media needs to be performed for selection of
suitable dissolution medium. The panel may determine the scientific rationale behind selection of two
different dissolution media and its scientific and regulatory importance in predicting the in vivo drug
release properties.
 Scientific rational behind adaptation of acceptance criteria as NLT 70% while the USP general chapter
<1092> The Dissolution Procedure: Development and Validation states that “ Typical acceptance criteria
for the amount of active ingredient dissolved, expressed as a percentage of the labeled content (Q), are in
the range of 75% to 80% dissolved”
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Availability
Group, / Pack size
Finished Product
Specification
2. M/s Pacific Zaniprill Tablets Form 5-D Zaneril Tablets by Recordati
Pharmaceuticals Ltd., 20/10mg 13-5-2016 Pharmaceuticals (MHRA
30 Km Multan Road, Each film coated PKR 50,000/- Approved)
Lahore, Pakistan. tablet contains: (DUPLICATE)
Enalapril 2x7’s, 4x7’s 13-4-2017: Panel recommends
maleate….20mg (As per SRO) renewal of DML
Lercanidipine
HCl….10mg
(ACE Inhibitor/CCB)
The firm has submitted stability study data along with required documents as per checklist approved in 251st
meeting of Registration Board. Detailsof submitted data are as under:
(Dy.# 2565 dated 19-1-2018)
Drug Zaniprill Tablets 20/10mg
Name of Manufacturer M/s Pacific Pharmaceuticals Ltd., 30 Km Multan Road, Lahore,
Pakistan.
Manufacturer of API Enalapril Maleate: Zhejiang Huahai Pharmaceutical Co. Ltd., China
Recordati Industria Chimica E Farmaceutica S.p.A.
Lercanidipine
Mfg site: Campoverde Via Mediana Cisterna, 4
hydrochloride:
04011 Campoverde Di Aprilia, Italy.
API Lot No. Enalapril Maleate: 5112-17-059
Lercanidipine
17100694
hydrochloride:
Description of Pack
Opaque PVDC blisters sealed with aluminum foil
Time Period Real time: 26 weeks
Accelerated: 26 weeks
Frequency Accelerated: 0,1,2,3,4,6,8,10,12,16,20,24,26 (Weeks)
Real Time: 0,1,2,3,4,6,8,10,12,16,20,24,26 (Weeks)
Batch No. T0106M T0206M T0306M
Batch Size 10,000 Tablet 10,000 Tablet 10,000 Tablet
Manufacturing Date Jun-2017 Jun-2017 Jun-2017
No. of Batches 03
Date of Submission Dy.# 24476 dated 14-12-2017
# Documents To Be Provided Status
1. COA of API
Yes
2. Approval of API by regulatory authority of Enalapril Maleate: Copy of GMP certificate issued
country of origin or GMP certificate of API by State Food & Drug Administration, China valid
manufacturer issued by regulatory authority of upto 25-09-2019 has been submitted for Enalapril.
country of origin. Lercanidipine hydrochloride: Firm has submitted
copy of Eudra GMP certificate based on inspection
conducted on 16-9-2016. The certificate has been
verified online from Eudra GMP database.
Yes
4. Data of 03 batches will be supported by
Yes
etc.
5. Documents confirming import of API etc. Enalapril Maleate: Firm has submitted invoice of
Gudia (Pvt) Ltd stating that their vendor has brought
the substance from China and have not submitted
any ADC attested invoice.
Lercanidipine hydrochloride: Firm has submitted
ADC attested commercial invoice dated 12-02-2016,
confirming import of API (micronized) 5Kg.
data / documents.

Yes
Yes
Rules, 1978.
 Firm has initially submitted ADC attested invoice for import of Lercanidipine hydrochloride dated 30-3-
2018, later the firm has submitted another invoice of Lercanadipine hydrochloride which was cleared on
12-02-2016. Panel may be requested to verify the exact batch of API used from the dispensing and
quality control log books.
 Firm has manufactured the stability batches in June 2017 and the stability studies were initiated in
February 2018. The Panel may verify the exact temperature and humidity conditions at which the batches
were kept during this time period before initiation of stability studies.
 Firm has initially submitted invoice of Gudia (Private) Limited Ref No. ZHP/008/2017 dated 3 rd June
2017 confirming import of 500g Enalapril maleate Batch No. 5112-17-059 and 100mg working standard
Batch No. 2014-199 through DHL. Upon clarification of DHL invoice without ADC clearance and
provision of tracking number of DHL, the firm submitted that their supplier took the material from
principal in their China visit. The firm submitted another copy of invoice of Gudia (Private) Limited with
same details of batch number and quantity but without any reference number, date and with different
signatures. The panel may be requested to verify the details of the import of enalapril maleate including
batch number of the imported API along with exact date of import.
 Firm has used different dissolution media for both API as per the following details:
API Specifications provided by the firm USP specification
Enalapril Apparatus: Paddle Apparatus: Paddle
maleate Speed: 50rpm Speed: 50rpm
Medium: RO Water Medium: pH 6.8 phosphate buffer
Volume: 900ml Volume: 900ml
Time: 30 mins Time: 30 mins
Acceptance criteria: NLT 70% in 30 min Acceptance criteria: NLT 80% (Q) of
labelled amount of C20H28N2O5 · C4H4O4 in
30 min
Lercanidipi Apparatus: Paddle Not available in any official pharmacopoeia
ne Speed: 50rpm
hydrochlori Medium: 0.3% w/v polysorbate 80 in 0.1N
de HCl (freshly prepared)
Volume: 900ml
Time: 45 mins
Acceptance criteria: NLT 70% in 45 min
 While the USP general chapter <1092> The Dissolution Procedure: Development and Validation states
that “Purified water is often used as the dissolution medium, but is not ideal for several reasons. First, the
quality of water can vary depending on the source of the water, and the pH value of the water is not
controlled. Second, the pH value can vary from day to day and can also change during the run,
depending on the active substance and excipients”. Further it recommends that solubility of the drug
along with profiling of drug release in the dissolution media needs to be performed for selection of
suitable dissolution medium. The panel may determine the scientific rationale behind selection of two
different dissolution media and its scientific and regulatory importance in predicting the in vivo drug
release properties.
 Scientific rational behind adaptation of acceptance criteria as NLT 70% while the USP general chapter
<1092> The Dissolution Procedure: Development and Validation states that “ Typical acceptance criteria
for the amount of active ingredient dissolved, expressed as a percentage of the labeled content (Q), are in
the range of 75% to 80% dissolved”
INSPECTION REPORT OF PACIFIC PHARMACEUTICALS LTD, LAHORE
General Information
Name of Manufacturer M/s Pacific Pharmaceuticals Ltd.
Physical Address 30 km Multan Road, Lahore
DML No. and Validity DML by way of formulation. No. 000295
Date of Inspection 28th January, 2019
Purpose of Inspection Panel inspection for verification of authenticity of stability data for
purpose of registration of drugs with reference to DRAP Islamabad
letter No. F.13-11/2017-PEC (Pt) dated 4th December, 2018
Name of Inspectors Mr Asim Rauf (Additional Director, DRAP, Lahore)
Ms Uzma Barkat (Area Federal Inspector of Drugs, Lahore)
Mr Hafiz Ahsan (Assistant Director,PEC, DRAP, Islamabad)
Name of firm representatives Mr Ahmad Junaid (Quality Control In charge)
accompanying during inspection Mr Ghazi Mustansar Riaz (Quality Assurance In charge)
Mr Farhan Bhatti (Dy. Compliance Manager)
Focus of Inspection
The inspection of M/s Pacific Pharmaceuticals Ltd., Lahore was conducted with reference to DRAP
Islamabad letter no. F.13-11/2017-PEC (Pt) dated 4th December, 2018, for verification of
authenticity of stability data of products namely Zaniprill Tablets 10/10mg and Zaniprill Tablets
10/20mg. The panel evaluated the relevant documentation and also visited the production area,
product development laboratory and quality control laboratory of the company. The data of both
products was evaluated in accordance with the checklist provided as given below.
Details of Investigation
A. ZANIPRILL TABLETS 10/10mg (Lercanidipine HCl and Enalapril maleate)
Sr.
No.
1. Do you have documents confirming the Firm had imported Lercanidipine HCl from
import of API? M/s Recordati, Ireland and Enalapril maleate
from M/s Zhejiang Huahai Pharmaceutical
Co. Ltd., China. Copy of invoice for import
attested by AD (I&E), DRAP, Lahore issue
no. 2355/2016-DRAP dated 15-02-2016 was
provided by firm. Enalapril Maleate was
imported through M/s Gudia Pvt Ltd, Lahore
and firm showed copy of a letter from M/s
Gudia whereby it was stated that the principal
handed over Enalapril maleate sample
1000gm and working standard 100mg to them
for onward submission to M/s Pacific
Pharmaceuticals, Lahore. No other document
related to import was available. It was counter
checked from QC sample incoming log book.
2. What was the rationale behind selecting Firm had been importing Lercanidipine from
the particular manufacturer of API? the same manufacturer since many years for
use in their registered product.
Firm’s management informed that the
manufacturer for Enalapril maleate was
selected through their vendor approval system.
3. Do you have documents confirming the Firm had Lercanidipine working standard and
import of reference standard and impurity standards (obtained from Recordati,
impurity standards? Ireland).
Working standard of Enalapril was obtained
from the principal manufacturer through
Gudia Private whereas secondary standard
was obtained from Sigma-Aldrich. Impurity
standards of Enalapril maleate were not
procured.
impurity standards?
of origin?
6. Do you use API manufacturer method of Firm used API manufacturer`s method of
testing? testing for Lercanidipine. Firm imported
Enalapril maleate USP but method of testing
applied was from BP monograph.
7. Do you have stability studies reports on Firm had stability studies reports on API as
API? provided by the manufacturer.
However, for Lercanidipine 12 months
accelerated and 24 months real time stability
studies report was available. For Enalapril 6
months accelerated and 18 months real time
stability studies report was available.
8. If yes, whether the stability testing has Yes, stability testing had been performed by
been performed as per SIM method and the manufacturer as per Stability Indicating
degradation products have been Method (SIM) and degradation products had
quantified? been quantified.
9. Do you have method for quantifying the Yes, firm had method obtained from
impurities in the API? manufacturer for quantifying the impurities in
the API. Lercanidipine was tested accordingly.
However, impurity testing was not performed
for Enalapril maleate by the firm.
10. Do you have some remaining quantities Yes, some remaining quantities of the working
of the API, its reference standard and standards and impurity standards of
impurities standards? Lercanidipine were available.
in product.
14. Do you have written and authorized The firm had written and authorized
protocols for the development of the formulation development report available for
product? the product.
15. Have you performed Drug-excipient Yes, firm had performed drug-excipient
compatibility studies? compatibility studies and excipients were
report provided.
16. Have you performed comparative No, firm had not performed comparative
dissolution studies? dissolution studies.
17. Do you have product development Yes, firm had R&D department.
(R&D) section?
18. Do you have necessary equipments At the time of inspection,

available in product development section renovation/upgradation was in progress in the
for development of the product? R&D lab and relevant equipment were not
installed. However, firm’s management
informed that they had the necessary
equipment which were currently
decommissioned due to revovation of the lab.
19. Are the equipments in product At the time of inspection,
development section qualified? renovation/upgradation was in progress in the
R&D lab and relevant equipment were not
installed.
20. Do you have proper maintenance / Yes, firm informed that they had a
calibration / re-qualification program for maintenance / calibration / re-qualification
the equipment used in PD section? program for the whole facility including
equipment used in PD section.
knowledge and training in product was available..
development? Firm was advised to further impart product
development specific training to their R&D
team.
batches for the stability studies of the for the stability studies of Zaniprill Tablets
product as required? 10/10mg with Batch No T0106M, T0206M
and T0306M. (batch size of 10,000 tablets).
23. What was the criteria for fixing the batch The criteria for fixing the batch size of
size of stability batches? stability batches, as informed by the firm was
one tenth of proposed commercial size batch.
26. Do you have developed and validated the Firm had taken method for assay and
method for testing of stability batches? dissolution testing from the method of their
existing product Lercanidipine tablets having
method and acceptance limits provided by M/s
Recordati.
For assay of Enalapril maleate in tablets,
testing method was taken from BP monograph
of Enalapril maleate tablets. Parameters for
dissolution and acceptance criteria were taken
from BP monograph of Enalapril maleate
tablets but quantification was done through
UV/VIS spectrophotometry using in house
developed method.
Four analytical method validation reports were
available. One each for quantitative assay of
Lercanidipine HCl and Enalapril maleate and
one each for dissolution of each API in
finished product. The parameter of robustness
of method was not mentioned in validation
reports.
27. Do you have method transfer studies in The method transfer studies were not
case when the method of testing being available.
lab?
29. Is your method of analysis stability The BP monograph of Enalapril tablets gives a
indicating? stability indicating method but it was seen that
BP monograph of Enalapril tablets was not
completely adopted by the firm for finished
product testing. Related substances testing had
not been done during stability studies as given
in the monograph. No acceptance criteria for
related substances had been given or defined
in finished product specifications. However,
in the stability studies protocol (initiated on
26-02-2018), Limit of degradation was given
as NMT 2.0% in specifications.
Firm had taken method for assay and
dissolution testing from the method of their
Recordati No acceptance criteria for related
substances had been given or defined in
finished product specifications. However, in
the stability studies protocol (initiated on 26-
02-2018), Limit of degradation was given as
NMT 2.0% in specifications.
30. Is your HPLC software 21CFR Four HPLC systems were used. Audit trail
compliant? was not installed on HPLC systems used at the
time of method validation and stability
studies.
31. Can you show Audit Trail reports on Data could only be verified from one system
product testing? by tracing it through manual log book. In rest
three there was some technical IT related issue
due to which back up data was not available at
the time of inspection. Relevant entries were
randomly checked from manual log books for
these systems.
batches?
34. Do you have valid calibration status for Firm had valid calibration status for the
the equipments used in production and equipment used in analysis of the product.
analysis? However, renovation/upgradation was in
progress in the production area and R&D lab
at the time of inspection and the area was shut
down.
35. Is proper and continuous monitoring and Yes, monitoring and control was available for
control available for stability chamber? the stability chambers provided. Digital data
loggers were provided and record was
randomly checked.
stability chambers and perform challenge test.
36. Can related manufacturing area, The QC laboratory was found to be GMP
equipment, personnel and utilities be compliant at the time of inspection.
rated as GMP compliant? Renovation/upgradation was in progress in the
production area and R&D lab at the time of
inspection and the area was shut down.
B. ZANIPRILL TABLETS 10/20mg (Lercanidipine HCl and Enalapril maleate)

Sr.
No.
1. Do you have documents confirming the Firm had imported Lercanidipine HCl from
import of API? M/s Recordati, Ireland and Enalapril maleate
from M/s Zhejiang Huahai Pharmaceutical
Co. Ltd., China. Copy of invoice for import
attested by AD (I&E), DRAP, Lahore issue
no. 2355/2016-DRAP dated 15-02-2016 was
provided by firm. Enalapril Maleate was
imported through M/s Gudia Pvt Ltd, Lahore
and firm showed copy of a letter from M/s
Gudia whereby it was stated that the principal
handed over Enalapril maleate sample
1000gm and working standard 100mg to them
for onward submission to M/s Pacific
Pharmaceuticals, Lahore. No other document
related to import was available. It was counter
checked from QC sample incoming log book.
2. What was the rationale behind selecting Firm had been importing Lercanidipine from
the particular manufacturer of API? the same manufacturer since many years for
use in their registered product.
Firm’s management informed that the
manufacturer for Enalapril maleate was
selected through their vendor approval system.
3. Do you have documents confirming the Firm had Lercanidipine working standard and
import of reference standard and impurity standards (obtained from Recordati,
impurity standards? Ireland).
Working standard of Enalapril was obtained
from the principal manufacturer through
Gudia Private whereas secondary standard
was obtained from Sigma-Aldrich. Impurity
standards of Enalapril maleate were not
procured.
impurity standards?
of origin?
6. Do you use API manufacturer method of Firm used API manufacturer`s method of
testing? testing for Lercanidipine. Firm imported
Enalapril maleate USP but method of testing
applied was from BP monograph.
7. Do you have stability studies reports on Firm had stability studies reports on API as
API? provided by the manufacturer.
However, for Lercanidipine 12 months
accelerated and 24 months real time stability
studies report was available. For Enalapril 6
months accelerated and 18 months real time
stability studies report was available.
8. If yes, whether the stability testing has Yes, stability testing had been performed by
been performed as per SIM method and the manufacturer as per Stability Indicating
degradation products have been Method (SIM) and degradation products had
quantified? been quantified.
9. Do you have method for quantifying the Yes, firm had method obtained from
impurities in the API? manufacturer for quantifying the impurities in
the API. Lercanidipine was tested accordingly.
However, impurity testing was not performed
for Enalapril maleate by the firm.
10. Do you have some remaining quantities Yes, some remaining quantities of the working
of the API, its reference standard and standards and impurity standards of
impurities standards? Lercanidipine were available.
in product.
14. Do you have written and authorized The firm had written and authorized
protocols for the development of the formulation development report available for
product? the product.
15. Have you performed Drug-excipient Yes, firm had performed drug-excipient
compatibility studies? compatibility studies and excipients were
report provided.
16. Have you performed comparative No, firm had not performed comparative
dissolution studies? dissolution studies.
17. Do you have product development Yes, firm had R&D department.
(R&D) section?
18. Do you have necessary equipments At the time of inspection,

available in product development section renovation/upgradation was in progress in the
for development of the product? R&D lab and relevant equipment were not
installed. However, firm’s management
informed that they had the necessary
equipment which were currently
decommissioned due to revovation of the lab.
19. Are the equipments in product At the time of inspection,
development section qualified? renovation/upgradation was in progress in the
R&D lab and relevant equipment were not
installed.
20. Do you have proper maintenance / Yes, firm informed that they had a
calibration / re-qualification program for maintenance / calibration / re-qualification
the equipment used in PD section? program for the whole facility including
equipment used in PD section.
knowledge and training in product was available..
development? Firm was advised to further impart product
development specific training to their R&D
team.
batches for the stability studies of the for the stability studies of Zaniprill Tablets
product as required? 10/20mg with Batch No T0106M, T0206M
and T0306M. (batch size of 10,000 tablets).
23. What was the criteria for fixing the batch The criteria for fixing the batch size of
size of stability batches? stability batches, as informed by the firm was
one tenth of proposed commercial size batch.
26. Do you have developed and validated the Firm had taken method for assay and
method for testing of stability batches? dissolution testing from the method of their
Recordati.
For assay of Enalapril maleate in tablets,
testing method was taken from BP monograph
of Enalapril maleate tablets. Parameters for
dissolution and acceptance criteria were taken
from BP monograph of Enalapril maleate
tablets but quantification was done through
UV/VIS spectrophotometry using in house
developed method.
Four analytical method validation reports were
available. One each for quantitative assay of
Lercanidipine HCl and Enalapril maleate and
one each for dissolution of each API in
finished product. The parameter of robustness
of method was not mentioned in validation
reports.
27. Do you have method transfer studies in The method transfer studies were not
case when the method of testing being available.
lab?
29. Is your method of analysis stability The BP monograph of Enalapril tablets gives a
indicating? stability indicating method but it was seen that
BP monograph of Enalapril tablets was not
completely adopted by the firm for finished
product testing. Related substances testing had
not been done during stability studies as given
in the monograph. No acceptance criteria for
related substances had been given or defined
in finished product specifications. However,
in the stability studies protocol (initiated on
26-02-2018), Limit of degradation was given
as NMT 2.0% in specifications.
Firm had taken method for assay and
dissolution testing from the method of their
Recordati No acceptance criteria for related
substances had been given or defined in
finished product specifications. However, in
the stability studies protocol (initiated on 26-
02-2018), Limit of degradation was given as
NMT 2.0% in specifications.
30. Is your HPLC software 21CFR Four HPLC systems were used. Audit trail
compliant? was not installed on HPLC systems used at the
time of method validation and stability
studies.
31. Can you show Audit Trail reports on Data could only be verified from one system
product testing? by tracing it through manual log book. In rest
three there was some technical IT related issue
due to which back up data was not available at
the time of inspection. Relevant entries were
randomly checked from manual log books for
these systems.
batches?
34. Do you have valid calibration status for Firm had valid calibration status for the
the equipments used in production and equipment used in analysis of the product.
analysis? However, renovation/upgradation was in
progress in the production area and R&D lab
at the time of inspection and the area was shut
down.
35. Is proper and continuous monitoring and Yes, monitoring and control was available for
control available for stability chamber? the stability chambers provided. Digital data
loggers were provided and record was
randomly checked.
stability chambers and perform challenge test.
36. Can related manufacturing area, The QC laboratory was found to be GMP
equipment, personnel and utilities be compliant at the time of inspection.
rated as GMP compliant? Renovation/upgradation was in progress in the
production area and R&D lab at the time of
inspection and the area was shut down.
CONCLUSION
During the course of inspection, the documents provided by the firm were reviewed, relevant areas
were visited and technical personnel were met and interviewed. Details of the evaluation have been
given in the questionnaire and the queries of the assessor have been addressed by the panel of
inspectors for further review and necessary action.
d. Exemption from onsite verification of stability data

Evaluator PEC-II
Sr.# Name & Brand Name Type of Form, International REMARKS
Address of (Proprietary Name + Initial Diary & Availability / (IF ANY)
Manufacturer / Dosage Form + Strength), Date, Fee Local
Applicant Composition, (including Availability
Pharmacological Group, differential fee),
Finished Product Demanded Price GMP
Specification / Pack size Inspection
Report Date
& Remarks
1231. "M/s Werrick Glad tablets 80mg Form-5D Approved by The firm has
Pharmaceuticals, "Each tablet contains: (Photocopy) Dy. USFDA claimed
Islamabad.” Azilsartan medoxomil (as dated 07-05-2011 Last GMP Manufacturer’s
potassium)…..80mg Rs. 8,000/- Dated inspection Specifications.
(Angiotensin II receptor 07-05-2011 conducted on
Inhibitor) (photocopy) 07-12-2017
Rs. 7000/- dated concluding
07-05-2011 good level of
(photocopy) GMP
Rs. 5,000/ dated compliance.
28-12-2018
Rs. 30,000/-
dated 25-01-2019
10’s,20’s,30’s
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Glad tablets 40mg
Name of Manufacturer M/s Werrick Pharmaceuticals, Islamabad.
Manufacturer of API M/s Ami Lifesciences Pvt Ltd, Block No. 82B, ECP Road, AT & Post
Karakhadi, Taluka, Padra, Dist: Baroda, State Gujarat, India.
API Lot No. AZP/50310517
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
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,1,2,3,4 & 6 (months)
Batch No. Trial# 01 Trial# 02 Trial# 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 authority Copy of GMP certificate (Certificate#. S-GMP/1704043)
of country of origin or GMP certificate of issued from Food and Drug Administration Gandhinagar,
API manufacturer issued by regulatory Gujarat state, India and is valid until 26-4-2019.
authority of country of origin.
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 etc. Copy of Commercial invoice (invoice# EXP/A/137/2017-
18) dated 31-07-2017, from M/s Ami Lifesciences Pvt.
Ltd. in the name of M/s Werrick Pharmaceuticals,
Islamabad for Azilsartan Medoxomil Potassium. Form 3
& Form 7 from M/s Ami Lifesciences Pvt. Ltd. in the
name of M/s Werrick Pharmaceuticals, Islamabad with
following details:
Batch No. Mfg. Date Quantity
Imported.
AZP/50310517 05-2017 0.9603Kg
vi. All provided documents will be attested Yes
vii. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
viii. Commitment to follow Drug Specification
Yes
Rules, 1978.
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale
Batches.
Sr.# Name & Brand Name Type of Form, International REMARKS

Address of (Proprietary Name + Initial Diary & Availability / (IF ANY)
Manufacturer / Dosage Form + Strength), Date, Fee Local
Applicant Composition, (including Availability
Pharmacological Group, differential fee),
Finished Product Demanded Price GMP
Specification / Pack size Inspection
Report Date
& Remarks
1232. "M/s Werrick Glad tablets 40mg Form-5D Approved by The firm has
Pharmaceuticals, "Each tablet contains: (Photocopy) Dy. USFDA claimed
Islamabad.” Azilsartan medoxomil (as dated 07-05-2011 Last GMP Manufacturer’s
potassium)…..40mg Rs. 8,000/- Dated inspection Specifications.
(Angiotensin II receptor 07-05-2011 conducted on
Inhibitor) (photocopy) 07-12-2017
Rs. 7000/- dated concluding
07-05-2011 good level of
(photocopy) GMP
Rs. 5,000/ dated compliance.
28-12-2018
Rs. 30,000/-
dated 25-01-2019
10’s,20’s,30’s
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug Glad tablets 40mg
Name of Manufacturer M/s Werrick Pharmaceuticals, Islamabad.
Manufacturer of API M/s Ami Lifesciences Pvt Ltd, Block No. 82B, ECP Road, AT & Post
Karakhadi, Taluka, Padra, Dist: Baroda, State Gujarat, India.
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
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,1,2,3,4 & 6 (months)
Batch No. Trial# 01 Trial# 02 Trial# 03
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
i. COA of API Yes
ii. Approval of API by regulatory authority Copy of GMP certificate (Certificate#. S-GMP/1704043)
of country of origin or GMP certificate of issued from Food and Drug Administration Gandhinagar,
API manufacturer issued by regulatory Gujarat state, India and is valid until 26-4-2019.
authority of country of origin.
iii. Protocols followed for conduction of
Yes
iv. Data of 03 batches will be supported by
chromatograms, laboratory reports, data Yes
sheets etc.
v. Documents confirming import of API etc. Copy of Commercial invoice (invoice# EXP/A/137/2017-
18) dated 31-07-2017, from M/s Ami Lifesciences Pvt.
Ltd. in the name of M/s Werrick Pharmaceuticals,
Islamabad for Azilsartan Medoxomil Potassium. Form 3
& Form 7 from M/s Ami Lifesciences Pvt. Ltd. in the
name of M/s Werrick Pharmaceuticals, Islamabad with
following details:
Imported.
AZP/50310517 05-2017 0.9603Kg
vi. All provided documents will be attested

(name, sign and stamp) for ensuring Yes
vii. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
viii. Commitment to follow Drug Specification
Yes
Rules, 1978.
 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 Glad
40mg & Glad 80 mg tablets vide Letter no. WP/RGA-482/1218 and WP/RGA-483/1218 respectively dated
27-12-2018 and provided the following documents in conjunction with the checklist approved by the
Registration Board in its 278th Meeting:
(Date of submission: 28-12-2018 vide diary no. 44302 & 44301)
1. Reference of last onsite panel inspection Firm has referred to onsite inspection reports of their product
for instant dosage form conducted “Cell-Tab tablets (Sofosbuvir +400 mg)”, which was
during last two years. presented in 276th meeting of Registration Board held on 27-
28th April, 2017
Observations: Keeping in view improvements made by the
firm as identified in the previous inspection, panel
recommends that facilities of the firm for production of Cell-
Tab (Sofosbuvir 400mg) Tablets rate as good.
Decision: Registration Board decided to approve registration

of “Cell-Tab (Sofosbuvir 400mg)” by M/s Werrick
Pharmaceuticals, Islamabad. Manufacturer will place first
three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for
six months.
2. Documents for the procurement of API Copy of Commercial invoice (invoice# EXP/A/137/2017-18)
with approval from DRAP (in case of dated 31-07-2017, from M/s Ami Lifesciences Pvt. Ltd. in the
import). name of M/s Werrick Pharmaceuticals, Islamabad for
Azilsartan Medoxomil Potassium. Form 3 & Form 7 from
M/s Ami Lifesciences Pvt. Ltd. in the name of M/s Werrick
Pharmaceuticals, Islamabad with following details:

Imported.
AZP/50310517 05-2017 0.9603Kg
3. Documents for the procurement of Firm has submitted a copy of invoice (invoice#
reference standard and impurity EXP/A/sample/2017-18) dated 18-08-2017, from M/s Ami
standards. Lifesciences Pvt. Ltd. in the name of M/s Morgan chemicals,
Karachi for Azilsartan (WRS) & Azilsartan (Impurity)
detailed as under:
Name Batch No. Quantity
Imported.
Azilsartan (WRS) AZP/WRS/IH/03 100mg
Azilsartan RD/16/A/AZI/03 80mg
(Impurity)
4. Approval of API/ DML/GMP certificate Copy of GMP certificate (Certificate#. S-GMP/1704043)
of API manufacturer issued by issued from Food and Drug Administration Gandhinagar,
regulatory authority of country of Gujarat state, India and is valid until 26-4-2019.
origin.
5. Mechanism for Vendor pre-qualification  The firm has submitted Work instruction for Evaluation
of Suppliers and vendors.
6. Certificate of analysis of the API, Photocopy of COA of Batch No. AZP/50310517 by M/s Ami
reference standards and impurity lifesciences, India is submitted.
standards Working standards: Photocopy of COA of Batch No.
AZP/50170217 & Batch No. AZR/RD/60121118 by M/s Ami
lifesciences, India is submitted.
Impurity Standard: Photocopy of COA of Batch No.
RD/16/A/AZI/03 by M/s Ami Lifesciences, India is
submitted.
7. Documents for the procurement of The firm has submitted photocopy of Purchase
excipients used in product Order/Invoices for the procurement of excipients used in
development? product development of Flozin tablet
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 10 members.
experience.
Production Data
9. Authorized Protocols/SOP for the  The firm has submitted photocopy of SOP for
development & stability testing of trial development of Glad 40mg & 80mg tablet & Stability
batches. 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 Glad 80mg Tablet & Glad 40mg
Tablet, such as.
Glad 80mg Tablet

Batch No. Date of Mfg. Batch Size
Trial# 01 16-03-2018 1500 Tablets
Trial# 02 16-03-2018 1500 Tablets
Trial# 03 16-03-2018 1500 Tablets
Glad 40mg Tablet

Batch No. Date of Mfg. Batch Size
Trial# 01 22-02-2018 1500 Tablets
Trial# 02 13-03-2018 1500 Tablets
Trial# 03 15-03-2018 1500 Tablets
11. Record of remaining quantities of The firm has submitted reconciliation sheet mentioning
stability batches. following details:
Glad 80mg Tablet

Batch No. Remaining Quantity
Trial# 01 33 packs (30’s)

Glad 40mg Tablet

Batch No. Remaining Quantity

QA / QC DATA
12. Record of Digital data logger for The firm has submitted photocopies of digital printouts for
temperature and humidity monitoring of Real Time and Accelerated Conditions for complete stability
stability chambers (real time and studies of applied formulations.
accelerated)
13. Method used for analysis of API along  The firm has submitted photocopy of raw material
with COA. specifications, raw material testing procedures for
Azilsartan Medoxomil Potassium.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Testing Procedure Glad 80mg Tablet & Glad 40mg Tablet
batches (i.e. chromatograms, lab reports, along with Stability Study Report of stability batches,
raw data sheets etc.) chromatograms, lab reports, raw data sheets etc.
15. Reports of stability studies of API from The firm has submitted stability studies reports on Azilsartan
manufacturer. Medoxomil Potassium salt for both Accelerated (30°C ± 2°C
/65% ± 5%RH) for 18 months & Long term (5°C ± 3°C)
conditions for 6 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 Glad
tablets.
17. Drug-excipients compatibility studies.  The firm has reported that no Physical & Chemical
incompatibilities were found on the basis of various
literatures.
 The firm has also mentioned as under:
“Stability studies (Accelerated & Real time) are
indicative of chemical and physical compatibility with
the drug product.
18. Record of comparative dissolution data.  Firm has submitted Comparative Dissolution Profile
protocol & reports. The details of reference product &
Sample product are as follows:
Glad 80mg Tablet

Feature Reference Product of M/s
product Werrick
Brand name Edarbi 80mg Glad 80mg tablet
tablet
Batch No. 68110 Trial# 01
Glad 40mg Tablet
Feature Reference Product of M/s
product Werrick
Brand name Edarbi 40mg Glad 80mg tablet
tablet
Batch No. 66621 Trial# 01
 Comparative dissolution studies have been performed in

following mediums:
a. pH 1.2 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 comparable results of
reference and applied product.
19. Compliance Record of HPLC software  Firm has submitted audit trail reports of stability
21CFR & audit trail reports on product studies of applied formulation
testing.
Observations/Queries Response by Firm

Copy of invoice submitted for import of working The supplier of M/s Werrick & M/s
standard and impurity standard has also been Scottmann is same i.e., Morgan chemicals
previously submitted in case of Azan tablets of hence same invoice was submitted.
M/s Scottmann.
 Submitted COA of API recommends storage at 2oC to 8oC.
 Firm has submitted stability studies of API from supplier at Accelerated i.e., 30°C ± 2°C /65% ± 5%RH
& Long term conditions i.e., 5°C ± 3°C, whereas innovator has performed stability of API at 25°C/60%
RH and 40°C/75% RH. Clarification shall be submitted in this regard.
 Applied formulation is a BCS class IV drug.
Decision:
Evaluator PEC-III
Sr. Name & Address Brand Name Type of Form, International Remarks
No. of Manufacturer (Proprietary Name Initial Diary & Availability /
/ Applicant + Dosage Form + Date, Fee Local
Strength), (including Availability
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date
Finished Product
Specification
1233. M/s. Highnoon Daploz 5mg Tablet Form 5D Farxiga Tablets
Laboratories 17.5 by Astrazaneca
Km, Multan Road, Each film coated Dairy No. 896 USFDA
Lahore tablet contains: dated 11-4-2016
Dapagliflozin (as GMP Inspection
propanediol Rs.50,000/- dated dated 27-9-2018
monohydrate)……..5 11-04-2016 confirms good
mg compliance to
14’s As per SRO GMP
Anti-diabetic rugs
Manufacturer’s
specification

Drug Daploz 5mg Tablet
Name of Manufacturer M/s. Highnoon Laboratories 17.5 Km, Multan Road, Lahore
Manufacturer of API MSN Laboratories Pvt Ltd. India
API Lot No. DQ0010217
Description of Pack Alu-Alu Blister
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:0,3,6 (months)
Real Time: 0,3,6 (months)
Batch No. RD 18013 RD 18014 RD 18015
Date of Initiation 02-2018 02-2018 02-2018
No. of Batches 03
No.
1. COA of API. Yes
2. Approval of API by regulatory authority of Copy of GMP certificate issued by Drugs Controlo
country of origin or GMP certificate of API Administration Government of Telangana dated
manufacturer issued by regulatory authority of 16-10-2017.
country of origin.

5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice
attested by AD (I&E) DRAP Lahore dated 28-03-
2017 confirming import of 5kg dapagliflozin
data / documents.
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 278th Meeting:
1. Reference of last onsite panel inspection for Firm has referred to their recent inspection report for
instant dosage form conducted during last two the product Nebvax 5/80mg Tablet which was
years. conducted on 1st January 2019. This product has not
yet considered in any meeting of Registration Board.
The inspection report is added in the same meeting
and firm has requested to grant them exemption on the
basis of same report which is being considered in the
instant meeting.
2. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). attested by AD (I&E) DRAP Lahore dated 28-03-
2017 confirming import of 5kg dapagliflozin.
3. Documents for the procurement of reference The firm has submitted copy of pre-shipment sample
standard and impurity standards. invoice for working standard and impurity standards.
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate issued by Drugs Controlo
API manufacturer issued by regulatory Administration Government of Telangana dated 16-
authority of country of origin. 10-2017.
5. Mechanism for Vendor pre-qualification The firm has submitted process flow of source
approval.
6. Certificate of analysis of the API, reference Firm has submitted copy of COA of API, reference
standards and impurity standards standard and impurity standards.
7. Documents for the procurement of excipients The firm has submitted copy of Commercial
used in product development? invoices/COAs of 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
development with relevant experience. in R&D department.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of product design and
development & stability testing of trial development SOP’s.
batches.
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 submitted record of remaining quantities of
batches. the stability batches
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
(real time and accelerated) stability 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
record of testing of stability batches (i.e. Testing 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 API but
manufacturer. not as per the conditions of Zone IV-A.
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 drug excipient compatibility
study results.
18. Record of comparative dissolution data. The firm has performed comparative dissolution
studies in three media including pH 1.2, pH 4.5 and
pH 6.8 buffers with Farxiga Tablets. The firm‘s
product results are comparable to that of the innovator
product.
19. Compliance Record of HPLC software Audit trail on testing reports of Daploz tablet has been
21CFR & audit trail reports on product submitted by the firm.
testing.
Remarks of the evaluator:
 The inspection report initially submitted by the firm for exemption did not confirmed audit trail reports
and 21CFR compliant HPLC. Later the firm has referred to their recent inspection report for the
product Nebvax 5/80mg Tablet which was conducted on 1st January 2019. This product has not yet
considered in any meeting of Registration Board. The inspection report is added in the instant meeting
and firm has requested to grant them exemption on the basis of same report which is being considered
in the instant meeting.
Observations Reply by the firm

Real-time stability study data of API as per the Firm has submitted that the API manufacturer
requirements of zone IV-A needs to be submitted, recommends storage conditions of 25oC and the
since the submitted data is not as per the conditions raw material was stored at same conditions in
of zone IV-A. Highnoon Laboratories. As API is used in
manufacture for finished product at Highnoon Lab
and it is not used by the patients, therefore we
request you to accept the long term stability data of
API as 25oC.
Firm has referred to WHO technical report series
No. 1010, 2018 Annex 10 titled “Stability testing
of pharmaceutical ingredients and finished
pharmaceutical product”
Justify the dissolution limits of NLT 80% (Q) after Firm has submitted that dissolution limit of NLT
30 minutes, while the dissolution time point used 80% (Q) after 30 mins is selected based on FDA
by the reference product i.e. Farxiga Tablets is 15 “guidance for industry, dissolution testing of
minutes (Ref: immediate release oral dosage forms”. According
https://www.accessdata.fda.gov/drugsatfda_docs/n to this document “For rapidly dissolving drugs
da/2014/202293Orig1s000ClinPharmR.pdf). (BSC Class 1, 3) a single point dissolution test
specification of NLT 85% (Q=80%) in 60 minutes
or less is sufficient. We have performed a
dissolution test of reference drug Forxiga Tablet
and our product Daploz Tablet. It has been noted
that in reference NDA document of Forxiga the
applicant have submitted the dissolution profile
with sampling times 15, 30, and 60 mins in support
of his request.

Finished Product
Specification
1234. M/s. Highnoon Daploz 10mg Tablet Form 5D Farxiga Tablets
Laboratories 17.5 by Astrazaneca
Km, Multan Road, Each film coated Dairy No. 895 USFDA
Lahore tablet contains: dated 11-04-2016
Dapagliflozin (as GMP Inspection
propanediol Rs.50,000/- dated dated 27-9-2018
monohydrate)……..1 11-04-2016 confirms good
0mg compliance to
14’s As per SRO GMP
Anti-diabetic rugs
Manufacturer’s
specification

Drug Daploz 10mg Tablet
Name of Manufacturer M/s. Highnoon Laboratories 17.5 Km, Multan Road, Lahore
Manufacturer of API MSN Laboratories Pvt Ltd. India
API Lot No. DQ0010217
Description of Pack Alu-Alu Blister
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 6 (months)
Frequency Accelerated:0,3,6 (months)
Batch No. RD 18016 RD 18017 RD 18018
No. of Batches 03
No.
1. COA of API. Yes
2. Approval of API by regulatory authority of Copy of GMP certificate issued by Drugs Controlo
country of origin or GMP certificate of API Administration Government of Telangana dated
manufacturer issued by regulatory authority of 16-10-2017.
country of origin.

5. Documents confirming import of API etc. Firm has submitted copy of commercial invoice
attested by AD (I&E) DRAP Lahore dated 28-03-
2017 confirming import of 5kg dapagliflozin
data / documents.
Rules, 1978.
its 278th Meeting:
1. Reference of last onsite panel inspection for Firm has referred to their recent inspection report for
instant dosage form conducted during last two the product Nebvax 5/80mg Tablet which was
years. conducted on 1st January 2019. This product has not
yet considered in any meeting of Registration Board.
The inspection report is added in the same meeting
and firm has requested to grant them exemption on the
basis of same report which is being considered in the
instant meeting.
2. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). attested by AD (I&E) DRAP Lahore dated 28-03-
2017 confirming import of 5kg dapagliflozin.
3. Documents for the procurement of reference The firm has submitted copy of pre-shipment sample
standard and impurity standards. invoice for working standard and impurity standards.
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate issued by Drugs Controlo
API manufacturer issued by regulatory Administration Government of Telangana dated 16-
authority of country of origin. 10-2017.
5. Mechanism for Vendor pre-qualification The firm has submitted process flow of source
approval.
6. Certificate of analysis of the API, reference Firm has submitted copy of COA of API, reference
standards and impurity standards standard and impurity standards.
7. Documents for the procurement of excipients The firm has submitted copy of Commercial
used in product development? invoices/COAs of excipients used in the formulation
of applied product.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of product design and
development & stability testing of trial development SOP’s.
batches.
10. Complete batch manufacturing record of three The firm has submitted copy of Batch Manufacturing
stability batches. Records of all the three Batches
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
13. Method used for analysis of API along with The firm has submitted copy of Raw Material
along with COA.
14. Method used for analysis of FPP & complete The firm has submitted copy of Finished Product
record of testing of stability batches (i.e. Testing 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 API but
manufacturer. not as per the conditions of Zone IV-A.
17. Drug-excipients compatibility studies. The firm has submitted drug excipient compatibility
study results.
pH 6.8 buffers with Farxiga Tablets. The firm‘s
product results are comparable to that of the innovator
product.
19. Compliance Record of HPLC software Audit trail on testing reports of Daploz tablet has been
21CFR & audit trail reports on product submitted by the firm.
testing.

 The inspection report initially submitted by the firm for exemption did not confirmed audit trail reports
and 21CFR compliant HPLC. Later the firm has referred to their recent inspection report for the
product Nebvax 5/80mg Tablet which was conducted on 1st January 2019. This product has not yet
considered in any meeting of Registration Board. The inspection report is added in the instant meeting
and firm has requested to grant them exemption on the basis of same report which is being considered
in the instant meeting.
Observations Reply by the firm

Real-time stability study data of API as per the Firm has submitted that the API manufacturer
requirements of zone IV-A needs to be submitted, recommends storage conditions of 25oC and the
since the submitted data is not as per the conditions raw material was stored at same conditions in
of zone IV-A. Highnoon Laboratories. As API is used in
manufacture for finished product at Highnoon Lab
and it is not used by the patients, therefore we
request you to accept the long term stability data of
API as 25oC.
Firm has referred to WHO technical report series
No. 1010, 2018 Annex 10 titled “Stability testing
of pharmaceutical ingredients and finished
pharmaceutical product”
Justify the dissolution limits of NLT 80% (Q) after Firm has submitted that dissolution limit of NLT
30 minutes, while the dissolution time point used 80% (Q) after 30 mins is selected based on FDA
by the reference product i.e. Farxiga Tablets is 15 “guidance for industry, dissolution testing of
minutes (Ref: immediate release oral dosage forms”. According
https://www.accessdata.fda.gov/drugsatfda_docs/n to this document “For rapidly dissolving drugs
da/2014/202293Orig1s000ClinPharmR.pdf). (BSC Class 1, 3) a single point dissolution test
specification of NLT 85% (Q=80%) in 60 minutes
or less is sufficient. We have performed a
dissolution test of reference drug Forxiga Tablet
and our product Daploz Tablet. It has been noted
that in reference NDA document of Forxiga the
applicant have submitted the dissolution profile
with sampling times 15, 30, and 60 mins in support
of his request.

Finished Product
Specification
1235. M/s. Scotmann Sacuval Tablets Form 5 Entresto Tablet of The firm had
Pharmaceuticals, 24/26mg Novartis pharms, initially
5D, I-10/3, Dairy No. 39647 USFDA applied with
Industrial Area, Each film coated dated 03-12-2018 Brand name of
Islamabad. tablet contains: GMP Inspection “Enscot
Sacubitril……..24mg Rs.20,000/- dated conducted on 10- Tablets
Valsartan…..…26mg 03-12-2018 10-2018 & 17-10- 24/26mg”.
Angiotensin II 2018 concluded Later on the
receptor blocker 4x5’s, 4x7’s, that the panel firm has
Manufacturer’s 2x10’s; As per unanimously requested to
specification SRO recommended for change the
the grant of brand name as
cGMP certificate. “Sacuval
Tablets
24/26mg.”
Drug Sacuval Tablet 24/26mg
Name of Manufacturer M/s. Scotmann Pharmaceuticals, 5D, I-10/3, Industrial Area, Islamabad.
Manufacturer of API M/s Zhuhai Rundu Pharmaceutical Co., Ltd, China
Description of Pack Alu Alu Blister Pack in Unit carton
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 26 (weeks)
Real Time: 26 (weeks)
Frequency 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)
Batch No. Trial #01 Trial #02 Trial #03
No. of Batches 03
No.
1. COA of API. Copy of COA (batch #20170203) from M/s Zhuhai
Rundu Pharmaceutical Co., Ltd, China is
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate No.
country of origin or GMP certificate of API GD20170777) issued by China Food & Drugs
manufacturer issued by regulatory authority of Administration, China. It is valid until 24-12-2022.
country of origin.

5. Documents confirming import of API etc.
 Copy of License to import drugs (Form 6) dated
09-05-2017.
 Copy of commercial invoice dated 14-06-2017
attested by ADC, DRAP, Islamabad
 Copy of clearance certificate dated 14-06-2017
data / documents.
Rules, 1978.
●
its 278th Meeting:
1. Reference of last onsite panel inspection for Registration Board decided to approve registration of
instant dosage form conducted during last two “DASCOT 30 mg Tablets (Daclatasvir 30 mg)” &
years. “DASCOT 60 mg Tablets (Daclatasvir 60 mg)” as
well as VELSCOT 400mg/100mg Tablet by M/s
Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad. Manufacturer will place first three
production batches on long term stability studies
throughout proposed shelf life and on accelerated
studies for six months.
Date of Inspection: 26-01-2018.
 The HPLC software is 21 CFR compliant.
 The firm has demonstrated all audit trail reports
for DASCOT 30 & 60mg tablet.
2. Documents for the procurement of API with Copy of commercial invoice has been submitted
approval from DRAP (in case of import). attested by ADC, DRAP Islamabad.
3. Documents for the procurement of reference The firm has submitted copies of invoices for the
standard and impurity standards. procurement of following working standard
substances:
Sacubitril sodium: 99.4 %
Valsartan Related compound C: 92 %
Valsartan Related compound B: 99.5 %
Valsartan : 100 %
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate
API manufacturer issued by regulatory (Certificate No.GD20170777) for M/s Zhuhai Rundu
authority of country of origin. Pharmaceutical Co., Ltd, China issued by Zhuhai
Food & Drug Administration, Guangdong Province,
China valid upto 24-12-2022.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for Evaluation of
Vendors.
6. Certificate of analysis of the API, reference  Copy of COA of API (Batch # 20170203) from
standards and impurity standards M/s Zhuhai Rundu Pharmaceutical Co., Ltd,
China has been submitted.
 Copy of COA of reference standard 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
formulation of applied product
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOP
development & stability testing of trial for the Development of SACUVAL Tablets
batches.
10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch
stability batches. Manufacturing Records of all the three Batches
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger record
and humidity monitoring of stability chambers for stability chambers with real time and accelerated
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material
along with COAs for Sacubitril/Valsartan Complex.
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. Testing Procedure for Sacuval Tablets along with
chromatograms, lab reports, raw data sheets Stability Study Reports.
etc.)
15. Reports of stability studies of API from The firm has submitted photocopy of 06 Months
manufacturer. Accelerated and 24 Months Real Time Stability Study
Data of 03 Batches of Sacubitril/Valsartan from M/s
Zhuhai Rundu Pharmaceutical Co., Ltd, China.
17. Drug-excipients compatibility studies. The firm has used the excipients of innovator.
pH 6.8 buffers with Entresto Tablets. The firm‘s
product results are comparable to that of the
comparator product.
19. Compliance Record of HPLC software Audit trail on testing reports of Sacubitril/Valsartan
21CFR & audit trail reports on product from has been submitted by the firm.
testing.

 The dissolution acceptance criteria adopted by the firm is NLT 85% in phosphate buffer pH 4.5
after 45 minutes, while the USFDA recommended time point for dissolution testing is after 25
minutes (Ref:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207620Orig1s000ChemR.pdf)
The dissolution results for comparative dissolution profile at pH 6.8 phosphate buffer at 15 and 30
minutes are as follows:
Phase-I
Drug Time point (min) Dissolution results (%)
Valsartan 15 63.58
30 80.34
Sacubitril 15 61.97
30 79.59
Phase-II
Drug Time point (min) Dissolution results (%)
Valsartan 15 67.08
30 83.57
Sacubitril 15 65.78
30 82.95
 Firm has used valsartan API manufactured by Zhejiang Rundu Pharmaceuticals, China. The
applicant has not performed impurity testing for NDMA or NDEA. The COA provided by the API
manufacturer do not confirm impurity testing for NDMA or NDEA as well.
Evaluator PEC-V
1236. Name and address of M/s Ferozsons Laboratories Limited , Amangarh Nowshera,
manufacturer / Applicant KPK
Brand Name +Dosage Form + Hexigard Gel 4%
Strength
Chlorhexidine …40mg
Chlorhexidine gluconate 7.1% eq. to chlorhexidine 4%
Diary No. Date of R& I & fee Dy. No. 26247; 31-07-2018; Rs. 50,000/-, 30-07-2018
Pharmacological Group Antiseptic and disinfectant
Finished product Specifications BP specs.
Approval status of product in Umbipro
Reference Regulatory Authorities WHO approved formulation
dosage form)
Recommends issuance of GMP.
Drug Hexigard Gel 4%
Name of Manufacturer M/s Ferozsons Laboratories Limited
Manufacturer of API M/s Smaart Pharmaceuticals, India
API Lot No. SMAART/CHG/2017/063
Description of Pack
10g gel filled in Al tube, crimped and sealed.
Accelerated: 06 Months
Frequency Real Time: 0,3,6 Months(on going)
Accelerated: 0,1,2,3,4,6 Months
Batch No. CHGel-001 CHGel-002 CHGel-003
Batch Size 6.5 kg 6.5 kg 6.5 kg
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. 26247; 31-07-2018
No.
9. COA of API Yes
Lot number: SMAART/CHG/2017/063
10. Approval of API by regulatory authority of country Certificate No. 6079163
of origin or GMP certificate of API manufacturer Valid up to 25-12-2018
issued by regulatory authority of country of origin. Issued by FDA, Maharashtra State
11. Protocols followed for conduction of stability study Yes
Invoice No: E-020
Not attested by ADC Attested
Quantity: 50 Kg
Form 6 ADC attested dated: 01-06-2017 and
batch no. not mentioned.
documents.
15. Commitment to continue real time stability study till Yes
assigned shelf life of the product.
1978.
instant dosage form conducted during last product “Quench Plus Cream”, which was conducted on
two years. 02nd May, 2018 and was presented in 283rd meeting of
Registration Board held on 27-29th June, 2018.
Following two observations were reported in the report:
i. The HPLC software is 21CFR Compliant.
ii. Firm has shown all Audit trail reports.
iii. 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 API with  Copy of Form 6 (License to Import drug for clinical
approval from DRAP (in case of import). trial examination, test or analysis) issued by ADC
(Karachi) dated 01-06-2017, for the import of
Chlorhexidine gluconate 20% solution BP, quantity
of drug 50.00kg has been submitted.
 Copy of Commercial Invoice (invoice no. E-020)
not attested by ADC has been submitted.
Batch No SMAART/CHG/2017/063.
3. Documents for the procurement of Firm has submitted DHL of Chlorhexidine Acetate
reference standard and impurity but receiver is Neon Chemicals.
standards. Firm has submitted that:
Neon Chemicals is authorized distributor of Smart
Pharmaceuticals in Pakistan.
4. Approval of API/ DML/GMP certificate of Certificate No. 6079163
API manufacturer issued by regulatory Valid up to 25-12-2018
authority of country of origin. Issued by FDA, Maharashtra State
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for the induction of new
vendor of raw material and packaging material in order
to ensure that the selected supplier will meet the supply
and quality requirements.
I. Material Management department will provide
samples of API in three different lots with new
vendor assessment form to quality control
department.
II. The samples will be analyzed in Lab against the
currant specifications and report will be
provided to material management Department.
In case of non-compliance, MQC will return the
form to MM Department with remarks.
III. After approval of samples by the QC
department the material Management
Department will arrange adequate quantity of
API along with stability studies and DMF
where possible to conduct a trial batch of the
Finished Product. The performance of the
material supplied will be judged by the results
of QC analysis of the stability samples.
IV. On the basis of the stability results successful
trials and vendor sample assessment, the
supplier will be accepted and rejected.
6. Certificate of analysis of the API, reference  Copies of COAs of API have been submitted,
standards and impurity standards detailed as under:
API Batch. # Quantity
Chlorhexidine SMAART/CHG 50 Kg
Gluconate 20 % /2017/063.
Solution
Chlorhexidine SMAART/QC/C 0.5g
Acetate H
Working A/WS/2017/002
standard
7. Documents for the procurement of The firm has submitted commercial invoices from
excipients used in product development? relevant manufacturers.
Excipient Manufacturer Batch No.
Benzalkonium Sigma 020M6884
Chloride 500ml
Guar Gum Pakistan Gum 037105
Super Gel 200 and Chemical 2 kg
2Kg
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience. staff along with their training record involved in
product development.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted SOP of Product development
development & stability testing of trial and protocol for stability studies.
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of Batch
three stability batches. Manufacturing Record and BPR of the following 03
Batches.
Batch No. Batch Size Yield
001 6.5Kg 6.2 Kg
002 6.5 Kg 6.250 Kg
003 6.3 Kg
11. Record of remaining quantities of stability Batch No. Batch Stability
batches. Produced Samples
001 479 85
002 495 85
003 480 856
QA / QC DATA
12. Record of Digital data logger for  The firm has submitted photocopies of digital
temperature and humidity monitoring of printouts of graphical chart for Real Time and
stability chambers (real time and Accelerated Conditions starting from 30-08-2018 to
accelerated) 31-08-2018 that shows excursions (54.6%RH ) .
Firm has submitted as follows:
When the doors of the climatic chamber are opened for
loading or unloading of the samples, there can be a
momentarily change in temperature and humidity.
However when the doors are shut, the set values are
recovered quickly.
Data logger values on 31/08/2018 at 08:53 am & 12:53
pm due to open of door at that moment. This
momentarily change has no influence on the stability
studies.
13. Method used for analysis of API along The firm has claimed BP method for analysis of API
with COA. but has not performed analysis accordingly.
Chlorhexidine Gluconate 20%
BP Firm specs.
Appearance Almost white liquid
Almost colourless or
pale-yellowish liquid
First identification A, B. A,C D
Second identification B,
C, D
pH (2.2.3) 5.5-5.7
5.5 to 7.0.
Impurity P Not performed
(chloroaniline)
Related substances Not performed
14. Method used for analysis of FPP & The firm has claimed BP method for analysis of FP
complete record of testing of stability but has not performed analysis accordingly.
batches (i.e. chromatograms, lab reports, Firm has submitted complete record of testing of
raw data sheets etc.) stability batches (i.e. chromatograms, lab reports,
raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted copies of reports of 06 Months
(30oC+2 oC, 65+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.
Tests BP Firm
Identification
Ist :B,E A, E
2nd :A,C,D,E
Appearance of  X
solution
Average  X
relative
molecular
mass and ratio
of alkyl
components
Impurities A,  X
B and C
Amines and  X
amine salts
Assay  X
17. Drug-excipients compatibility studies. Not performed.
18. Record of comparative dissolution data. Not performed.
19. Compliance Record of HPLC software Firm has submitted audit trail reports for stability
21CFR & audit trail reports on product studies analysis of three batches.
testing.
Evaluation by PEC:
Sr. Reply
Deficiencies/Shortcomings
No
1. Invoice No: E-020
Not attested by ADC Attested
Commercial invoice is not ADC attested. Quantity: 50 Kg
Form 6 ADC attested dated: 01-06-2017 and
batch no. not mentioned.
2. For the quantitation formula, in chromatographic
method, normally USP & BP recommends the
peak areas, if the sample and reference
concentrations are the same. Please see the
attached pharmacopeia reference.
“In the linear range, peak areas and peak heights
are usually proportional to the quantity of
compound eluting. The peak areas and peak
heights are commonly measured by electronic
integrators but may be determined by more
Provide reference for assay calculation
classical approaches. Peak areas are generally
formula i.e. Assay=average sample area
used but may be less accurate if peak interference
/average standard areax100.
occurs. The components measured are separated
from any interfering components. Peak tailing
and fronting is minimized, and the measurement
of peaks on tails of other peaks are avoided when
possible.”
Evaluation
The following justification is insufficient to
justify the provided formula.
Moreover, raw data sheets does not confirm
that concentration is same.
3. Viscosity is a measure of a formulation’s
Viscosity to be established after completion
resistance to flow and is an assessment of a
of stability studies. Clarify.
rheological property of a semi solid dosage form.
As viscosity limits are not identified in the BP
specific drug product monograph, so we perform
extra testing and study the viscosity of our
Hexigard Gel, during the stability studies for six
months. The viscosity limits are as follows;
Viscosity: 44500 – 43500 cp.
4. British Pharmacopeia (BP) recommends 100µl
injection volume, however the General
Monograph allows for Adjustment of
Chromatographic Conditions accordingly. Please
refer to BP 2018 general monograph (attached).
In our analysis development, the injection volume
Injection volume in BP is 100ul whereas,
of 100 µl gave a very high peak response which
you have used 20ul.Justify.
goes to infinity (injection volume 100 µl
chromatogram attached for your reference).
Therefore, it was determined that injection
volume 20 µl is sufficient to give a high
resolution peak and the same was used for our
method development.
5. Variation in retention time of API and The chromatographic conditions are not
internal standard at different time points constant due to seasonal changes in ambient
and same time points between standard temperature. Therefore, seasonal temperature
and sample e.g. 9.2 min of standard and change results in variation of the retention
7.8 min of sample of initial time point for time. However this has no effect on the testing
batch no CHGel-001. Justify and clarify procedure or on the accuracy of the test.
the variations.
6. Due to extensive and detailed study of
analytical method validation, HPLC column
get overloaded and it need a long time to wash
the column. While performing 4th month
stability studies, this problem was observed
and then we recover the column through very
long term washing procedure so that it can
maintain its actual position. The regeneration
Batch no 001, accelerated condition, at 4
and washing of column behavior reflects in our
month time point, the peak of internal
6th month stability data chromatograms which
standard and API are very close to each
had been already submitted to you.
other and this trend vary from other
Whereas low resolution is concerned, the
time points i.e. the resolution is very
minimum requirement of resolution in the
poor. Justify and clarify the variations.
chromatographic analysis is more than 1.50
(please see the attached highlighted
references). In the 4th month stability studies,
chromatograms shows two components of the
sample are well separated and the resolution
value of all the chromatograms is more than
1.60 (please see the attached 4th month study
chromatograms with highlighted resolution).
7. Firm has not submitted COAs of impurity Firm has submitted COA of impurity standard but
standards. has not performed impurities.
8. When the doors of the climatic chamber are
The digital printouts of graphical chart
opened for loading or unloading of the
for Accelerated Conditions starting from
samples, there can be a momentarily change in
30-08-2018 to 31-08-2018 shows
temperature and humidity. However when the
excursions (as low as 54.6%RH). Provide
doors are shut, the set values are recovered
justification.
quickly.
Data logger values on 31/08/2018 at 08:53 am
& 12:53 pm due to open of door at that
moment. This momentarily change has no
influence on the stability studies.
9. Path case study is a working paper prepared
Explanation is required regarding path for the UN Commission on Life saving
case study, as mentioned in Drug- commodities for women and children for
excipients compatibility studies? appropriate Technology in Health through
USAID program.
10. Molecular Weight of Chlorhexidine Gluconate
(CHXG)= 897.762
Molecular Weight of Chlorhexidine (CHX)=
505.452
Factor= 897.762/505.452 =1.777
We, Have 20% CHXG Solution
Submit and justify the formula for For 1ml of 7.1% CHXG Solution, we require=
potency adjustment for API. 7.1/20= 0.355ml (of 20% CHXG Solution)
7.1% CHXG= 4% CHX
Assay/Potency API=100.85%
So, for Batch Size 6.5Kg = (0.355*6.5*100)=
2.308 Kg CHXG
Remarks: Adjustment of potency not required
since potency is more than 100%.
11. We followed the formulation available in
working paper, prepared for the UN commission
on Life-saving commodities for women and
children, attached.
In Ferozson’s formulation, Benzalkonium
Chloride is used which is most frequently used
as preservative.
The manufacturer of Umbipro also used the
antimicrobial preservative (Sodium Acetate
trihydrate), which may be for any reasons
suiting the manufacturer.
Umbipro Formulation:
Umbipro Formulation:
Ingredients Role
No preservative is used in innovator Chlorhexidine API
formulation i.e. Umbipro whereas, you Gluconate
have used preservative i.e. Benzalkonium Guar Gum Gelling Agent
Chloride. Justify. Sodium Acetate Antimicrobial
Trihydrate Preservative
Purified Water Solvent
Whereas SMPC mentions as follows:

Sodium acetate trihydrate was shown to result in
the lowest level of drug-related impurities and
was selected as the pH stabiliser.
Moreover, the case study data provided by firm
mentions the following statement regarding the
safe use of benzalkonium chloride.
“Some manufacturers have chosen to add small
amounts of 50 % benzalkonium chloride(0.10%)
to CHX products as a preservative but stability
tests conducted by PATH have shown that this
may not be a crucial addition.
Identification test clarification
BP has recommended 4 qualitative
The reference for API Specs. is BP but identification test A, B, C, D. We have
testing is not performed as per BP. performed 3 out of 4 qualitative tests which
Chlorhexidine Gluconate confirm the identity of the material. Test B was
BP Firm specs. not performed due to non-availability of
Appearance Almost white liquid reference standard of Calcium gluconate by B.P.
Almost Impurity P (chloroaniline)
colourless or British Pharmacopeia (BP) provides the
pale-yellowish impurity testing on specialized Gas
liquid Chromatograph equipped with detector ECD
First A,C D (Electron Capturing).
12. identification Since the Electron capturing Detector (ECD)
A, B. cell contains a Radioactive Isotope 63Ni and it
Second is a Radioactive source, therefore the import of
identification this detector is prohibited by Pakistan Nuclear
B, C, D Regulatory Authority (PNRA) for commercial
pH (2.2.3) 5.5-5.7 use (please see the highlighted information for
5.5 to 7.0. your record).
Impurity P Not performed We have the facility of Gas Chromatograph
(chloroaniline) equipped with FID (Flame Ionization detector),
Related Not performed which is most commonly used in
substances pharmaceutical API/Excipients and product
testing.
BP has recommended 5 qualitative

identification test A, B, C, D, E. Previously, we
Tests BP Firm have performed 2 out of 5 qualitative tests
Benzalkonium Chloride
Identificati Ist :B,E A, E which confirm the identity of the material. Test
on 2nd:A,C,D,E C and D performed dated: 07-02-2019, See
attached revised COA.
Appearance  X
Test B could not performed due to non-
of solution
availability of Benzalkonium chloride for
Average  X
system suitability CRS standard by B.P.
relative
Appearance of solution
molecular
Test performed dated: 07-02-2019.
mass and
Average relative molecular mass and ratio of
ratio of
alkyl components
alkyl
Test was not performed due to non-availability
13. components
of Benzalkonium chloride for system suitability
Impurities  X
CRS standard
A, B and C
Impurities A, B and
Amines and  X
Impurities not performed due to non-availability
amine salts of impuirty standard A, impuirty standard B and
Assay  X impuirty standard C by B.P.
Amines and amine salts
Test performed dated: 07-02-2019.
Assay
Average relative molecular mass value used in
the calculation of assay, whereas Average
relative molecular mass test was not performed
due to non-availability of Benzalkonium
chloride for system suitability CRS standard
Appearance clarification
It is to clarify that our analyst mistakenly
wrote description “Almost white liquid”
instead of clear colorless liquid”
The BP mentions appearance as almost
COA of API from Smaart Pharmaceuticals is
colorless or pale-yellowish liquid while
14. attached bearing appearance as “clear
you have mentioned almost white liquid.
colorless liquid” and sample of API is also
Clarify
provided herewith our clarification for your
visual inspection.
Copy of corrected analysis report with
initials of that analyst for API.
New API and excipients are provisionally
The COA of API and COA of
approved based on QC testing and Finally
benzalkonium chloride mentions that
15. approved for commercial use after
these raw materials are provisionally
completing trials and stability studies to
approved. Clarify and Justify the same.
make sure product is stable during stability
The SMPC of Umbipro mentions that
sodium acetatae trihydrate was selected as Sodium acetate trihydrate has dual action i.e. As
16. the pH stabilizer. While you have pH stabilizer as well as Preservative.
mentioned it as an antimicrobial agent.
Clarify.
Evaluator PEC-VII
No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local
Applicant Dosage Form + Strength), Fee (including Availability
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
1237. M/s Scotmann Trapeze plus XR tablet Form-5-D Janumet XR –USFDA
Pharmaceuticals, 5- 50/1000 mg Dy. No: 42024 approved
D, I-10/3, Industrial Each tablet contains: Dated. 7/12/18
Area, Islamabad Sitagliptin phosphate Rs.20,000/- (5-12-18) GMP compliant dated
monohydrate eq. to 7’s, 2x7’s, 1x10’s and 10-10-2018 & 17-10-
Sitagliptin……50 mg 10x6’s 2018 concluding the
Metformin As per SRO panel unanimously
hydrochloride………..1000 recommends for the
mg (as extended release grant of GMP certificate.
core)
Anti-diabetic

Drug Trapeze plus XR tablet 50/1000 mg
Name of Manufacturer M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad.
Manufacturer of API Sitagliptin phosphate monohydrate: M/s Zhejiang Tianyu Pharmaceutical Co.,
Ltd. No 15 Donghai avenue Zheijang provincial and medical raw material
base linhai zone, Taizhou city, Zheijang province China
Metformin HCl: M/s Abhilasha Pharma Pvt. Ltd, INDIA
API Lot No. Sitagliptin phosphate monohydrate: 12301-17030101
Metformin HCl: MET123/17
Description of Pack
Alu / Alu Blister Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 1,2,3, 4 ,6 (Months)
Real Time : 0, 3 ,6 (Months)
Batch No. Trail 001 Trail 001 Trail 001
Manufacturing Date 12 - 2017 12 – 2017 12 - 2017
No. of Batches 03
Date of Submission 4/1/2019
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of Sitagliptin phosphate monohydrate: Copy of
country of origin or GMP certificate of API GMP certificate (Certificate No. ZJ20170020)
manufacturer issued by regulatory authority of for M/s Zhejiang Tianyu Pharmaceutical Co.,
country of origin. Ltd. No 15 Donghai avenue Zheijang provincial
and medical raw material base linhai zone,
Taizhou city, Zheijang province China issued by
Zheijang province Food & Drug Administration,
valid upto 3/28/2022.
Metformin HCl: GMP Certificate of
manufacturer (#1706138) “M/s Abhilasha
Pharma Pvt. Ltd, INDIA” issued by Food &
Drugs Control Administration, Gandhinagar,
Gujarat State, India is provided by applicant
which is valid till 01/06/2019.
Yes
5. Documents confirming import of API etc. Copy of ADC attested Form 5, form 3 and
commercial invoice provided for both actives.
Sitagliptin: Quantity 50 kg
Metformin: Quantity 1000 kg
documents.
Yes
Yes
1978.
Data for exemption from On-site investigation of submitted stability data
1. Reference of last onsite panel  Registration Board approved Dascot 30 and 60 mg Tablets
inspection for instant dosage form and Velscot tablet conducted on 26 jan 2018 in 278
conducted during last two years. meeting.
 Date of Inspection: 26 jan 2018.
 The HPLC is 21CFR Compliant.
 Audit trail on the testing reports of ― Dascot 30 and 60
mg Tablets and Velscot tablet were available.
2. Documents for the procurement of Sitagliptin phosphate monohydrate: The firm has submitted
API with approval from DRAP (in photocopies of ADC attested document dated 3-july-2017,
case of import). ADC attested Form 5, Commercial Invoice attestation on
dated 05/7/2017 for 50 kg of Sitagliptin. The firm has
imported “Sitagliptin” Raw Material ,Qty ; 50 kg ; Batch #
12301-17030101
Metformin HCl: The firm has submitted photocopies of ADC
(Islamabad) attested Form 5 and AD attested commercial
invoice dated 6/9/17. Commercial Invoice is issued by M/s
Abhilasha Pharma Pvt. Ltd, INDIA Moreover detail of Qty ;
1000 kg ; Batch # MET123/17 is mentioned on invoice.
3. Documents for the procurement of The firm has submitted the commercial invoice of the
reference standard and impurity reference standard for both metformin and setagliptin
standards.
4. Approval of API/ DML/GMP Sitagliptin phosphate monohydrate: Copy of GMP
certificate of API manufacturer certificate (Certificate No. ZJ20170020) for M/s Zhejiang
issued by regulatory authority of Tianyu Pharmaceutical Co., Ltd. No 15 Donghai avenue
country of origin. Zheijang provincial and medical raw material base linhai
zone, Taizhou city, Zheijang province China issued by
Zheijang province Food & Drug Administration, valid upto
3/28/2022.
Metformin HCl: GMP Certificate of manufacturer

(#1706138) “M/s Abhilasha Pharma Pvt. Ltd, INDIA” issued
by Food & Drugs Control Administration, Gandhinagar,
Gujarat State, India is provided by applicant which is valid till
01/06/2019
5. Mechanism for Vendor pre-  The firm has submitted copy of vender evaluation
qualification questionnaire for vender pre-qualification along with
filled questionnaire from APIs manufacturer.
6. Certificate of analysis of the API,  Sitagliptin API:
reference standards and impurity Photocopy of COA of Batch No. 12301-17030101 issued by
standards “M/s. M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China”
is submitted.
 Reference standards and impurity standards:
The firm has submitted copy of Reference Standard
Metformin HCl API:
Photocopy of COA of Batch No. MET123/17 issued by M/s
Abhilasha Pharma Pvt. Ltd, INDIA is submitted.
The firm has submitted copy of Working Standards
(Metformin HCl),USP Reference Standard and impurity
standards provided by the API Manufacturer - M/s Abhilasha
Pharma Pvt. Ltd, INDIA
7. Documents for the procurement of Firm has submitted copy of commercial invoices for the
excipients used in product excipients used in the applied formulation.
development?
8. List of qualified staff involved in Firm has submitted copy of R&D staff list.3 pharmacists and
product development with relevant 1 MSc are present in there R &D
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted copy of SOP with the title
development & stability testing of ‘Manufacturing methodology of Sitagliptin/Metformin HCl
trial batches. XR tablet” and “Stability protocols of trapeze plus XR tablet”
Effective date 30/11/2017
10. Complete batch manufacturing The firm has submitted copy of Trial batch manufacturing
record of three stability batches. record. Details are as under:
Batch Bach size Mfg.
No. Started
Trail#1 1500 Tabs 12-2017
Trail#2 1500 Tabs 12-2017
Trail#3 1500 Tabs 12-2017
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
12. Record of Digital data logger for  Previously Reported in panel inspection:
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) & for 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
along with COA. analysis 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
stability batches (i.e. its validation data.
chromatograms, lab reports, raw data  Complete record of testing of stability batches (i.e.
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 Apixaban: The firm has submitted copy of accelerated, 06
from manufacturer. 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
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 not submitted Drug-excipients compatibility
studies. studies and provides excipient analysis report
18. Record of comparative dissolution  Firm has submitted Comparative dissolution study of their
data. product Trapeze plus XR with Innovator’s Brand
“Janumet XR” conducted on following dates ;
following media:
Sitagliptin :
i. 0.01N Hydrochloric Acid Solution
ii. pH 4.5 Acetate buffer solution.
iii. pH 6.8 phosphate buffer solution.
METFORMIN HCl :
i. 0.01N Hydrochloric Acid 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 The firm has submitted copy of Audit Trail for Initial, 3 rd and
software 21CFR & audit trail reports 6th Month Testing Intervals
on product testing.
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:
Formulation is according to innovator using wet granulation for core preparation and incorporation of
sitagliptin in coating solution,
v. Firm has submitted revised finished product testing method along with stability studies data.
vi. Dissolution parameters stated in finished product testing method, submitted along with stability studies
data are not as per recommended by USFDA.
Sr.# Deficiency/Observation Response by Pharma.
i. Why baseline is not stable in The baseline of provided

comparative dissolution chromatograms of comparative
chromatograms (e.g. in case of spl dissolution is stable the scale was
dissolution 30 min pH 6.8). Justify magnified to view the sitagliptin peak at
the maximum because the peak high of
sitagliptin is too low.
ii. Documents for the procurement of Documents for impurity standard were
impurity standards missing for provided
sitagliptin phosphate monohydrate
iii. How it could be justified that the The specificity of UV method was
results of dissolution analysis for performed during method development
Metformin as performed by UV which shows that the both actives
method have not been interfered with absorbs at different wavelength and do
the other API i.e. sitagliptin phosphate not interfere each other even placebo
monohydrate present in the same was also run during specificity
sample aliquot.
iv. Innovator performs propyl gallate The WHO has set an estimated
assay as propyl gallate is carcinogenic acceptable daily limit of intake of
Justify the exemption of these test by propyl gallate at up to 1.4 mg/kg as per
API manufacturer and applicant. guideline the average 70 kg person can
take 98 mg per day while we are using 1
mg per tablet in our product which is
negligible to cause any carcinogenic
effect.
Decision:

No. Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local
Applicant Dosage Form + Strength), Fee (including Availability
Pharmacological Group, Demanded Price / GMP Inspection
Finished Product Pack size Report Date &
1238. M/s Scotmann Trapeze plus XR tablet Form-5-D Janumet XR –USFDA
Pharmaceuticals, 5- 50/500 mg Dy. No: 42025 approved
D, I-10/3, Industrial Each tablet contains: Dated. 7/12/18
Area, Islamabad Sitagliptin phosphate Rs.20,000/- (5-12-18) GMP compliant dated
monohydrate eq. to 7’s, 2x7’s, 1x10’s and 10-10-2018 & 17-10-
Sitagliptin………….50mg 10x6’s 2018 concluding the
Metformin As per SRO panel unanimously
hydrochloride………...500 recommends for the
mg (as extended release grant of GMP certificate.
core)
Anti-diabetic

Drug
Trapeze plus XR tablet 50/500 mg
Name of Manufacturer M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad.
Manufacturer of API Sitagliptin phosphate monohydrate: M/s Zhejiang Tianyu Pharmaceutical Co.,
Ltd. No 15 Donghai avenue Zheijang provincial and medical raw material
base linhai zone, Taizhou city, Zheijang province China
Metformin HCl : M/s Abhilasha Pharma Pvt. Ltd, INDIA
API Lot No. Sitagliptin phosphate monohydrate: 12301-17030101
Metformin HCl: MET123/17
Description of Pack
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
Manufacturing Date 12 - 2017 12 – 2017 12 - 2017
No. of Batches 03
Date of Submission 23/10/2018
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of Sitagliptin phosphate monohydrate: Copy of
country of origin or GMP certificate of API GMP certificate (Certificate No. ZJ20170020)
manufacturer issued by regulatory authority of for M/s Zhejiang Tianyu Pharmaceutical Co.,
country of origin. Ltd. No 15 Donghai avenue Zheijang provincial
and medical raw material base linhai zone,
Taizhou city, Zheijang province China issued by
Zheijang province Food & Drug Administration,
valid upto 3/28/2022.
Metformin HCl: GMP Certificate of
manufacturer (#1706138) “M/s Abhilasha
Pharma Pvt. Ltd, INDIA” issued by Food &
Drugs Control Administration, Gandhinagar,
Gujarat State, India is provided by applicant
Yes
5. Documents confirming import of API etc. Copy of ADC attested Form 5, form 3 and
commercial invoice provided for both actives.
Sitagliptin: Quantity 50 kg
Metformin: Quantity 1000 kg
documents.
Yes
Yes
1978.
1. Reference of last onsite panel  Registration Board approved Dascot 30 and 60 mg Tablets
inspection for instant dosage form and Velscot tablet conducted on 26 jan 2018 in 278
conducted during last two years. meeting.
 Date of Inspection: 26 jan 2018.
 Audit trail on the testing reports of ― Dascot 30 and 60
mg Tablets and Velscot tablet were available.
2. Documents for the procurement of Sitagliptin phosphate monohydrate: The firm has submitted
API with approval from DRAP (in photocopies of ADC attested document dated 3-july-2017,
case of import). ADC attested Form 5, Commercial Invoice attestation on
dated 05/7/2017 for 50 kg of Sitagliptin. The firm has
imported “Sitagliptin” Raw Material ,Qty ; 50 kg ; Batch #
12301-17030101
Metformin HCl : The firm has submitted photocopies of
ADC (islamabad) attested Form 5 and AD attested
commercial invoice dated 6/9/17. Commercial Invoice is
issued by M/s Abhilasha Pharma Pvt. Ltd, INDIA Moreover
detail of Qty ; 1000 kg ; Batch # MET123/17 is mentioned on
invoice.
3. Documents for the procurement of The firm has submitted the commercial invoice of the
reference standard and impurity reference standard for both metformin and setagliptin
standards.
4. Approval of API/ DML/GMP Sitagliptin phosphate monohydrate: Copy of GMP
certificate of API manufacturer certificate (Certificate No. ZJ20170020) for M/s Zhejiang
issued by regulatory authority of Tianyu Pharmaceutical Co., Ltd. No 15 Donghai avenue
country of origin. Zheijang provincial and medical raw material base linhai
zone, Taizhou city, Zheijang province China issued by
Zheijang province Food & Drug Administration, valid upto
3/28/2022.
Metformin HCl: GMP Certificate of manufacturer
(#1706138) “M/s Abhilasha Pharma Pvt. Ltd, INDIA” issued
by Food & Drugs Control Administration, Gandhinagar,
Gujarat State, India is provided by applicant which is valid till
01/06/2019
5. Mechanism for Vendor pre-  The firm has submitted copy of vender evaluation
qualification questionnaire for vender pre-qualification along with
6. Certificate of analysis of the API,  Sitagliptin API:
reference standards and impurity Photocopy of COA of Batch No. 12301-17030101 issued by
standards “M/s. M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China”
is submitted.

The firm has submitted copy of Reference Standard
Metformin HCl API:
Photocopy of COA of Batch No. MET123/17 issued by M/s
Abhilasha Pharma Pvt. Ltd, INDIA is submitted.

The firm has submitted copy of Working Standards
(Metformin HCl),USP Reference Standard and impurity
standards provided by the API Manufacturer - M/s Abhilasha
Pharma Pvt. Ltd, INDIA
excipients used in product excipients used in the applied formulation.
development?
8. List of qualified staff involved in Firm has submitted copy of R&D staff list.3 pharmacists and
product development with relevant 1 MSc are present in there R &D
experience.
Production Data
development & stability testing of ‘Manufacturing methodology of Sitagliptin/Metformin HCl
trial batches. XR tablet” and “Stability protocols of trapeze plus XR tablet”
Effective date 30/11/2017
10. Complete batch manufacturing The firm has submitted copy of Trial batch manufacturing
record of three stability batches. record. Details are as under:
No. Started
Trail#1 1500 Tabs 11-2017
Trail#2 1500 Tabs 11-2017
Trail#3 1500 Tabs 11-2017
11. Record of remaining quantities of Trapeze plus XR ;

stability batches. Stability Pack Size :
other are remaining
other are remaining
other 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) & for Accelerated Stability studies)
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
along with COA. analysis of APIs along with COA.
complete record of testing of Specifications and Testing Method of applied product and
stability batches (i.e. its validation data.
chromatograms, lab reports, raw data  Complete record of testing of stability batches (i.e.
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 The firm has submitted copy of accelerated, 06 Months
from 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
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 not submitted Drug-excipients compatibility
studies. studies and provides excipient analysis report
18. Record of comparative dissolution  Firm has submitted Comparative dissolution study of their
data. product Trapeze plus XR with Innovator’s Brand
“Janumet XR”
following media:
Sitagliptin :
iv. 0.01N Hydrochloric Acid Solution
v. pH 4.5 Acetate buffer solution.
vi. pH 6.8 phosphate buffer solution.
METFORMIN HCl :
iv. 0.01N Hydrochloric Acid Solution
v. pH 4.5 Acetate buffer solution.
vi. 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 The firm has submitted copy of Audit Trail for Initial, 3 rd and
software 21CFR & audit trail reports 6th Month Testing Intervals
on product testing.
Evaluation by PEC:
i. Why baseline is not stable in The baseline of provided

comparative dissolution chromatograms of comparative
chromatograms (e.g. in case of spl dissolution is stable the scale was
dissolution 30 min pH 6.8). Justify magnified to view the sitagliptin peak at
the maximum because the peak high of
sitagliptin is too low.
ii. Documents for the procurement of Documents for impurity standard were
impurity standards missing for provided
sitagliptin phosphate monohydrate
iii. How it could be justified that the The specificity of UV method was
results of dissolution analysis for performed during method development
Metformin as performed by UV which shows that the both actives
method have not been interfered with absorbs at different wavelength and do
the other API i.e. sitagliptin phosphate not interfere each other even placebo
monohydrate present in the same was also run during specificity
sample aliquot.
iv. Innovator performs propyl gallate The WHO has set an estimated
assay as propyl gallate is carcinogenic acceptable daily limit of intake of
Justify the exemption of these test by propyl gallate at up to 1.4 mg/kg as per
API manufacturer and applicant. guideline the average 70 kg person can
take 98 mg per day while we are using 1
mg per tablet in our product which is
negligible to cause any carcinogenic
effect.
Decision:
No. Manufacturer / Applicant (Proprietary Name Initial Diary & Date, Availability / Local
+ Dosage Form + Fee (including Availability
Composition, Demanded Price / GMP Inspection
Pharmacological Pack size Report Date &
Group, Remarks
Finished Product
Specification
1239. M/s Werrick Api-Tab tablet 5 mg Form-5-D ELIQUIS (USFDA
Pharmaceuticals, Plot # 216, Each film coated Dy. No: 42913 Approved)
217, I-10/3, Industrial Area, tablet contains: Dated.6-6-2017 GMP inspection report
Islamabad. Apixaban USP Rs.20,000/- (17-12- conducted on Last
……….5mg 18) inspection was
Antithrombotic 10’s ; Rs. 316/- conducted on 7-2-2017
agents concluding very good
compliance

Drug Api-Tab tablet 5 mg
Name of Manufacturer M/s Werrick Pharmaceuticals, Plot # 216, 217, I-10/3, Industrial Area,
Islamabad.
Manufacturer of API Apixaban: M/s Glenmark pharmaceuticals ltd. Plot # 3109 C, GIDC
industrial estate Ankleshwar-393002, Gujrat India.
API Lot No. Apixaban:
Description of Pack
Alu / PVC Blister Pack
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 1,2,3,4, 6 (Months)
Batch No. Trail #1 Trail #2 Trail #3
Batch Size 1500 Tablets 1500Tablets 1500 Tablets
No. of Batches 03
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of country Apixaban: Firm has submitted copy of GMP
of origin or GMP certificate of API manufacturer Certificate of manufacturer “M/s Glenmark
issued by regulatory authority of country of origin. pharmaceuticals ltd. Plot # 3109 C, GIDC
industrial estate Ankleshwar-393002, Gujrat
India.
Yes
respective documents like chromatograms, laboratory Yes
5. Documents confirming import of API etc. Copy of invoice provided. Not ADC
(Islamabad) attested
documents.
7. Commitment to continue real time stability study till
Yes
Yes
1978.
 Dissolution is according to USFDA.
1. Reference of last onsite panel inspection for  Last onsite inspection of werrick pharmaceuticals was
instant dosage form conducted during last conducted on 19-4-2017 for Cell tab tablets
two years. (Sofosbuvir tablet). Approved in 273meeting
o Date of Inspection: 19-4-2017
o The HPLC is 21CFR Compliant.
o Audit trail on the testing reports was
available and confirmed. Panel reviewed chromatograms
for testing of API and trial batches audit trail at 0, 3 and 6
months for real time and accelerated stability testing
2. Documents for the procurement of API Apixaban: The firm has submitted photocopies of
with approval from DRAP (in case of Commercial Invoice attestation by ADC islamabad
import). The firm has imported “Apixaban” Raw Material, Qty; 0.1
kg; Batch # 801704823 from same source via Invoice #
2006007416 dated: 29-9-2017.
Clearance certificate # 2960 is provided.
Form 7, form 3
3. Documents for the procurement of  The firm has submitted that the reference standard and
reference standard and impurity standards. impurity standards are procured along with the APIs’
consignment and not separately.
4. Approval of API/ DML/GMP certificate of Apixaban: The Firm has submitted copy of GMP
API manufacturer issued by regulatory Certificate of manufacturer “M/s Glenmark
authority of country of origin. pharmaceuticals Ltd. Plot # 3109 C, GIDC industrial estate
Ankleshwar-393002, Gujrat India issued by food and drug
control administration Gandhinagar Gujrat state India
5. Mechanism for Vendor pre-qualification  The firm has submitted copy of vender evaluation
questionnaire for vender pre-qualification along with
6. Certificate of analysis of the API, reference  Apixaban:
standards and impurity standards Photocopy of COA of Batch No. 801704823 issued by
“M/s Glenmark pharmaceuticals ltd. Plot # 3109 C, GIDC
industrial estate Ankleshwar-393002, Gujarat India is
submitted.
The firm has submitted copy of COA of Working
Standards and impurity standards provided by the API
Manufacturer
excipients used in product development? excipients used in the applied formulation.
8. List of qualified staff involved in product Firm has submitted copy of R&D staff list.10 persons
development with relevant experience. present in there R &D 8 are pharmacist, 1 MPhil
microbiology and 1 MPhil chemistry
Production Data
development & stability testing of trial ‘Authorized Protocol For Development of Api-tab 5 mg.
batches. Effective date 16-2-2018
10. Complete batch manufacturing record of The firm has submitted copy of Trial batch manufacturing
three stability batches. record. Details are as under:
No. Started
Trail#1 1500 Tabs 3-2018
Trail#2 1500 Tabs 3-2018
Trail#3 1500 Tabs 3-2018
11. Record of remaining quantities of stability Api-Tab 5 mg ;

batches. Stability Pack Size : 1 x 10’s
Yield 1218 Tablets (121 Packs) ,
28 Packs used for testing
93 packs are remaining
QA/QC DATA
temperature and humidity monitoring of The firm has installed software for recording the
stability chambers (real time and temperature/Humidity of the chamber (for real time
accelerated) stability & for Accelerated Stability studies)
logger for temperature and humidity monitoring of
stability chambers.
13. Method used for analysis of API along with  The firm has submitted photocopy of method used for
COA. analysis of APIs (Apixaban) along with COA.
complete record of testing of stability Specifications and Testing Method of Api-tab 5 mg
batches (i.e. chromatograms, lab reports, and its validation data.
raw data sheets etc.)  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 Apixaban: The firm has submitted copy of accelerated,
manufacturer. 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 Apixaban
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients
(titanium dioxide, polysorbate tween 80, SLS, HPMC, Mg
stearate, Lactose tablettose, and Microcrystalline cellulose,
cross carmilose, talcum, used in the applied formulation.
17. Drug-excipients compatibility studies. The firm has not performed Drug-excipients compatibility
studies and has referred to monographs of Hand-book of
Pharmaceutical Excipients in this regard and claimed
Stability studies are indicative of chemical and physical
compatibility with the drug product
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study of
their product (Api-tab 5 mg) with Innovator’s Brand
Eliquis 5 mg” conducted on following dates ;
The details are as follows:
Feature Reference Product
Product Pharma
Brand name Eliquis 5 mg Api-tab 5 mg
Tablets Apixaban
 Comparative dissolution studies have been performed

in following media:
Apixaban:
vii. 0.01N Hydrochloric Acid Solution
viii. pH 4.5 Acetate buffer solution.
ix. pH 6.8 phosphate buffer solution.
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
testing.
Evaluation by PEC:
i. Provide the complete inspection report of cell tab Provided and verified that HPLC
to show evidence of The 21CFR Compliant of is 21 CFR compliant and audit
HPLC and trails are available
Audit trail on the testing reports of cell tab 400 mg
tablets
ii. On Commercial invoice ADC attestation is not Attested copy is provided
readable and clear
iii. List of qualified staff involved in product Provided
development with relevant experience does not
mentioned their qualifications
iv. The particle size of the drug substance was The particle size of API
identified as a critical factor based on its influence manufacture was determined by
on the dissolution of the tablets. A study was API manufacturer as mentioned in
conducted to establish the drug substance particle COA of API (Particle size is
size requirement that would produce the required mentioned as D (90)= 82.4 um)
in-vitro drug release and appropriate limit has been
se
https://www.ema.europa.eu/documents/assessment-
report/eliquis-epar-public-assessment-
report_en.pdf
v. Why there is additional peaks along with principle There are no additional peaks in
peaks in chromatograms of drug assay and the assay chromatograms where as
dissolution area at different time points (e.g. in the dissolution chromatograms
accelerated study, 1 month vial 2, 4, 5 etc.) the extra peaks are due to the
dissolution medium
vi. Why baseline is not stable and there are extra peaks The baseline and extra peaks in
in comparative dissolution chromatograms. comparative dissolution
chromatograms are due to
different dissolution mediums
used
Decision:
No. Manufacturer / Applicant (Proprietary Name Initial Diary & Date, Availability / Local
+ Dosage Form + Fee (including Availability
Composition, Demanded Price / GMP Inspection
Pharmacological Pack size Report Date &
Group, Remarks
Finished Product
Specification
1240. M/s Werrick Api-Tab tablet 2.5 Form-5-D ELIQUIS (USFDA
Pharmaceuticals, Plot # 216, mg Dy. No: 42914 Approved)
217, I-10/3, Industrial Area, Each film coated Dated.17-12-2018 GMP inspection report
Islamabad. tablet contains: Rs.20,000/- (17-12- conducted on Last
Apixaban USP 18) inspection was
……….2.5 mg 10’s ; Rs. 316/- conducted on 7-2-2017
Antithrombotic concluding very good
agents compliance

Drug Api-Tab tablet 2.5 mg
Name of Manufacturer M/s Werrick Pharmaceuticals, Plot # 216, 217, I-10/3, Industrial Area,
Islamabad.
Manufacturer of API Apixaban: M/s Glenmark pharmaceuticals ltd. Plot # 3109 C, GIDC
industrial estate Ankleshwar-393002, Gujrat India.
API Lot No. Apixaban:
Description of Pack
Alu / PVC Blister Pack
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 1,2,3,4, 6 (Months)
Batch No. Trail #1 Trail #2 Trail #3
Batch Size 1500 Tablets 1500Tablets 1500 Tablets
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of country Apixaban: Firm has submitted copy of GMP
of origin or GMP certificate of API manufacturer Certificate of manufacturer “M/s Glenmark
issued by regulatory authority of country of origin. pharmaceuticals Ltd. Plot# 3109 C, GIDC
industrial estate Ankleshwar-393002, Gujrat
India.
License #: 1708289
Yes
respective documents like chromatograms, laboratory Yes
5. Documents confirming import of API etc. Copy of invoice provided. Not ADC
(Islamabad) attested
documents.
7. Commitment to continue real time stability study till
Yes
Yes
1978.
 Dissolution is according to USFDA.
1. Reference of last onsite panel inspection for Last onsite inspection of werrick pharmaceuticals was
instant dosage form conducted during last conducted on 19-4-2017 for Cell tab tablets
two years. (Sofosbuvir tablet). Approved in 273meeting
o Date of Inspection: 19-4-2017
o The HPLC is 21CFR Compliant.
o Audit trail on the testing reports was
o available and confirmed. Panel reviewed
chromatograms for testing of API and trial batches
audit trail at 0, 3 and 6 months for real time and
accelerated stability testing
2. Documents for the procurement of API Apixaban: The firm has submitted photocopies of
with approval from DRAP (in case of Commercial Invoice attested by ADC Islamabad
import). The firm has imported “Apixaban” Raw Material, Qty; 0.1
kg; Batch # 801704823 from same source via Invoice #
2006007416 dated: 29-9-2017.
Clearance certificate # 2960 is provided.
Form 7, form 3
3. Documents for the procurement of  The firm has submitted that the reference standard and
reference standard and impurity standards. impurity standards are procured along with the APIs’
consignment and not separately.
4. Approval of API/ DML/GMP certificate of Apixaban: The Firm has submitted copy of GMP
API manufacturer issued by regulatory Certificate of manufacturer “M/s Glenmark
authority of country of origin. pharmaceuticals Ltd. Plot # 3109 C, GIDC industrial estate
Ankleshwar-393002, Gujrat India issued by food and drug
control administration Gandhinagar Gujrat state India
5. Mechanism for Vendor pre-qualification  The firm has submitted copy of vender evaluation
questionnaire for vender pre-qualification along with
6. Certificate of analysis of the API, reference  Apixaban:
standards and impurity standards Photocopy of COA of Batch No. 801704823 issued by
“M/s Glenmark pharmaceuticals ltd. Plot # 3109 C, GIDC
industrial estate Ankleshwar-393002, Gujarat India is
submitted.
The firm has submitted copy of COA of Working
Standards and impurity standards provided by the API
Manufacturer
8. List of qualified staff involved in product Firm has submitted copy of R&D staff list.10 persons
development with relevant experience. present in there R &D 8 are pharmacist, 1 MPhil
microbiology and 1 MPhil chemistry
Production Data
development & stability testing of trial ‘Authorized Protocol For Development of Api-tab 2.5 mg.
batches. Effective date 16-2-2018
10. Complete batch manufacturing record of The firm has submitted copy of Trial batch manufacturing
three stability batches. record. Details are as under:
No. Started
Trail#1 1500 Tabs 3-2018
Trail#2 1500 Tabs 3-2018
Trail#3 1500 Tabs 3-2018
11. Record of remaining quantities of stability Api-Tab 2.5 mg ;

batches. Stability Pack Size : 1 x 10’s
QA/QC DATA
temperature and humidity monitoring of The firm has installed software for recording the
stability chambers (real time and temperature/Humidity of the chamber (for real time
accelerated) stability & for Accelerated Stability studies)
logger for temperature and humidity monitoring of
stability chambers from April till oct 2018.
13. Method used for analysis of API along with  The firm has submitted photocopy of method used for
COA. analysis of APIs (Apixaban) along with COA.
complete record of testing of stability Specifications and Testing Method of Api-tab 2.5 mg
batches (i.e. chromatograms, lab reports, and its validation data.
raw data sheets etc.)  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 Apixaban: The firm has submitted copy of accelerated,
manufacturer. 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 Apixaban
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients
(titanium dioxide, polysorbate tween 80, SLS, HPMC, Mg
stearate, Lactose tablettose, and Microcrystalline cellulose,
cross carmilose, talcum, used in the applied formulation.
17. Drug-excipients compatibility studies.  Stability studies are indicative of chemical and
physical compatibility with the drug product
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study of
their product (Api-tab 2.5 mg) with Innovator’s
Brand Eliquis 2.5 mg” conducted on following dates ;
The details are as follows:
Feature Reference Product
Product Pharma
Brand name Eliquis 2.5 mg Api-tab 2.5
Tablets mg Apixaban

Comparative dissolution studies have been performed
in following media:
Apixaban:
x. 0.01N Hydrochloric Acid Solution
xi. pH 4.5 Acetate buffer solution.
xii. pH 6.8 phosphate buffer solution.
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
testing.
Evaluation by PEC:
S# Deficiency/Observation Response by Pharma.
I. Provide the complete inspection report of cell tab Provided and verified that HPLC
to show evidence of The 21CFR Compliant of is 21 CFR compliant and audit
HPLC and trails are available
Audit trail on the testing reports of cell tab 400 mg
tablets
II. On Commercial invoice ADC attestation is not Attested copy is provided
readable and clear
III. List of qualified staff involved in product Provided
development with relevant experience does not
mentioned their qualifications
IV. The particle size of the drug substance was The particle size of API
identified as a critical factor based on its influence manufacture was determined by
on the dissolution of the tablets. A study was API manufacturer as mentioned in
conducted to establish the drug substance particle COA of API (Particle size is
size requirement that would produce the required mentioned as D (90)= 82.4 um)
in-vitro drug release and appropriate limit has
been se
https://www.ema.europa.eu/documents/assessment
-report/eliquis-epar-public-assessment-
report_en.pdf
V. Why there is additional peaks along with principle
There are no additional peaks in
peaks in chromatograms of drug assay and the assay chromatograms where as
dissolution area at different time points (e.g. in the dissolution chromatograms
accelerated study, 1 month vial 2, 4, 5 etc.) the extra peaks are due to the
dissolution medium
VI. Why baseline is not stable and there are extra The baseline and extra peaks in
peaks in comparative dissolution chromatograms. comparative dissolution
chromatograms are due to
different dissolution mediums
used
Decision:

Composition, Demanded Price / Pack GMP Inspection
Pharmacological size Report Date &
Group, Remarks
Finished Product
Specification
1241. M/s Tabros Pharma Experta Tablet 90 Form-5D BRILINTA of
(Pvt) limited, L-20/B, mg Dy. No. Astrazenica
Sector-22, Federal B Each film coated 09-04-2015 USFDA Approved.
Industrial Area, tablet contains: Rs. 50,000/- Not applicable
Karachi Ticagrelor… 90 mg Pack Size:
(Anti-coagulant) 14’s GMP compliant dated
In-house 178.57/- 07/02/18
Specifications “On the basis of current
inspection it was
observed that the firm
rectified all observations
noted during last GMP
Inspection.”

Drug
Experta Tablet 90 mg
Name of Manufacturer M/s Tabros Pharma (Pvt) limited, L-20/B, Sector-22, Federal B Industrial
Area, Karachi
Manufacturer of API Ticagrelor:: Nantong Chanyoo Pharmatech Co., Ltd, China, address: No.2,
Tonghai Si Road, Yangkou chemical industrial park, Rudong coastal
economic development zone, Nantong Jiangsu province 226407, PR china
API Lot No. Ticagrelor: TGL-160301
Description of Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 3 ,6 (Months)
Real Time : 0, 3 ,6 ,9, 12, 18 (Months)
Batch No. TR001/EXP TR002/EXP TR003/EXP
Manufacturing Date 2 - 2017 2– 2017 2– 2017
Date of Initiation 15-2-2017 15-2-2017 15- 2-2017
No. of Batches 03
Date of Submission 23/10/2018 (Dy. No. 36409-B)
No.
1. COA of API Yes
2. Approval
0 of API by regulatory authority of Tecaglore: Firm has submitted copy of GMP
country of origin or GMP certificate of API Certificate of manufacturer Nantong Chanyoo
manufacturer issued by regulatory authority of Pharmatech Co., Ltd, China, address: No.2, Tonghai
country of origin. Si Road, Yangkou chemical industrial park, Rudong
coastal economic development zone, Nantong
Jiangsu province 226407, PR china valid till
7/9/2020
Yes
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested invoice provided
for 0.1 kg of Ticagrelor provided in which issuer is
Changzhou pharmaceuticals factory no. 2 cailing
road Changzhou Jiangsu china
sign and stamp) for ensuring authenticity of data Yes
/ documents.
Yes
Yes
Rules, 1978.
1. Reference of last onsite  Registration Board approved Nisita Tablets 60 mg and Vibrenta
panel inspection for instant tablet 400/100 mg in its 279 Meeting.
dosage form conducted o Date of Inspection: 19-02-2017.
during last two years. o The HPLC is 21CFR Compliant.
o Audit trail on the testing were available.
2. Documents for the Tecaglore: The firm has submitted photocopies of ADC (Karachi)
procurement of API with attested Form 6 dated 05-12-2017, Commercial Invoice attestation on
approval from DRAP (in dated 22/2/18 for 0.1 kg of Tecaglore. Batch # TGL-160301 from
case of import). Changzhou pharmaceuticals factory no. 2 cailing road Changzhou
Jiangsu china
3. Documents for the  The firm has submitted analytical reports/COA of reference
procurement of reference standard & impurity standards.
standard and impurity  The firm has clarified that the reference standard and impurity
standards. standards are provided free of cost along with the APIs’ consignment
and not separately by Nantong chanyoo.
4. Approval of API/ The Firm has submitted copy of GMP Certificate of manufacturer
DML/GMP certificate of “Nantong Chanyoo Pharmatech Co., Ltd, China, address: No.2, Tonghai
API manufacturer issued Si Road, Yangkou chemical industrial park, Rudong coastal economic
by regulatory authority of development zone, Nantong Jiangsu province 226407, PR china.
country of origin.
5. Mechanism for Vendor  The firm has submitted copy of vender evaluation questionnaire
pre-qualification for vender pre-qualification along with filled questionnaire from both
APIs manufacturers.
6. Certificate of analysis of  Tecaglore API:
the API, reference Photocopy of COA of Batch No. TGL-160301 issued by “M/s Nantong
standards and impurity Chanyoo Pharmaceutical Co., Ltd. China” is submitted.
standards
The firm has submitted copy of Working Standards and impurity
standards provided by the API Manufacturer
7. Documents for the Firm has submitted copy of commercial invoices for the excipients used
procurement of excipients in the applied formulation.
used in product
development?
8. List of qualified staff Firm has submitted copy of R&D staff list.2 pharmacists and 2 BSC are
involved in product present in there R &D
development with relevant
experience.
Production Data
9. Authorized Protocols/SOP The firm has submitted copy of SOP with the title ‘Product
for the development & Development Protocols’.
stability testing of trial Effective date 28-02-2017.
batches.
10. Complete batch The firm has submitted copy of Trial batch manufacturing record.
manufacturing record of Details are as under:
three stability batches. Experta Tablet 90 mg
Batch No. Bach size Mfg. Started
TR001/EXP 165 Tabs 2-2017

TR002/EXP 165 Tabs 2-2017
TR003/EXP 165 Tabs 2-2017
11. Record of remaining
quantities of stability  TR001: Batch Size : 165 Tablets
batches. Remaining: 28 tablets
 TR002: Batch Size : 165 Tablets
Remaining: 28 tablets
QA/QC DATA
12. Record of Digital data The firm has submitted copy of record of digital data logger (Logit
logger for temperature and Chart, Technoman) for temperature and humidity monitoring of stability
humidity monitoring of chambers.
stability chambers (real
time and accelerated)
13. Method used for analysis  The firm has submitted photocopy of method used for analysis
of API along with COA. of APIs along with COA.
14. Method used for analysis  The firm has submitted photocopy of Finished Product
of FPP & complete record Specifications and Testing Method of Complete record of testing of
of testing of stability stability batches (i.e. chromatograms, lab reports, raw data sheets etc.)
batches (i.e. are submitted with 06 months stability data (Accelerated) & Real Time.
chromatograms, lab
reports, raw data sheets
etc.)
15. Reports of stability studies Tacagrelor: The firm has submitted copy of accelerated, 06 Months
of API from manufacturer. (40°C ± 2°C & 75±5%RH) & long term, 12 Months (25°C ± 2°C &
60±5%RH) stability study reports of 03 batches
16. Analysis reports for The firm has submitted copy of COAs for the excipients used in the
excipients used. applied formulation.
17. Drug-excipients  The firm has not submitted Drug-excipients compatibility
compatibility studies. studies and has referred to the Innovator Product (Brilinta).
18. Record of comparative  Firm has submitted Comparative dissolution study of their
dissolution data. product with Innovator’s Brand “ Brilinta” conducted on following
dates ;
 The details are as follows:
Product Tabross
Pharma
Brand name Brilinta Experta Tablet
Tablets 90 mg
90 mg
Mfg. date Not mentioned 2-2017
19. Compliance Record of The firm has submitted copy of Audit Trail for march 2018 to august
HPLC software 21CFR & 208, but the data from Feb 2017-feb 2018 were un-retrievable from the
audit trail reports on system but firm claim to have hard copies of chromatograms
product testing.
Evaluation by PEC:
i. On commercial invoice Firm provided the statement by Changzhou
different manufacturer was pharmaceuticals factory declare that Nantong chanyoo
mentioned. On commercial pharmatech Co.Ltd located No 2 tonghai Sirod Yangkou
invoice Changzhou chemicals industrial park, rudong coastal economic
pharmaceutical is mentioned development zone, Nantong Jiangsu province 226407,
and GMP provided is of PR China is our wholly owned subsidiary.
Nantong Jiangsu
Stability of API ticaglerol is Manufacturer has started stability study at zone IV-A
at 25°C ± 2°C & 60±5%RH conditions and completed 1 month stability data. And
undertake to provide 12 month real time stability
The GMP certificate of Valid GMP is provided, valid up to 7/9/2020
Nantong Jiangsu is valid till
November 2018, provide
valid GMP
Comparative dissolution is Dissolution is performed on 3 mediums at 4.5, 1.2 and
not performed according to 6.8 on fresh trail batch, dissolution was performed at 5,
recommended methods on 3 10, 15, 20, 30, 45 and 60 minutes.
pH medium.
Exact polymorphic form
could not be verified as no
data of types of polymorphic
forms available/provided by
the firm and it’s not possible
to precisely identify the
stable polymorphic form of
Ticagrelor.
Decision:

Group,
Finished Product
Specification
1242. M/s Tabros Pharma Experta Tablet 60 Form-5D BRILINTA of
(Pvt) limited, L-20/B, mg Dy. No. Astrazenica
Sector-22, Federal B 31835 USFDA Approved.
Industrial Area, Each film coated 16-Nov-2015 Not applicable
Karachi tablet contains: Rs. 50,000/-
Ticagrelor… 60 mg Pack Size: GMP compliant dated
(Anti-coagulant) 14’s
In-house 142.87/-
Specifications

Drug
Experta Tablet 60 mg
Name of Manufacturer M/s Tabros Pharma (Pvt) limited, L-20/B, Sector-22, Federal B Industrial
Area, Karachi
Manufacturer of API Ticagrelor:: Nantong Chanyoo Pharmatech Co., Ltd, China, address: No.2,
Tonghai Si Road, Yangkou chemical industrial park, Rudong coastal
economic development zone, Nantong Jiangsu province 226407, PR china
API Lot No. Ticagrelor: TGL-160301
Description of Pack
Real Time : 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0, 3 ,6 (Months)
Real Time : 0, 3 ,6 ,9, 12, 18 (Months)
Batch No. TR001/EXP TR002/EXP TR003/EXP
Manufacturing Date 2 - 2017 2– 2017 2– 2017
Date of Initiation 15-2-2017 15-2-2017 15- 2-2017
No. of Batches 03
Date of Submission 23/10/2018 (Dy. No. 36409-B)
No.
1. COA of API
Yes
2. Approval
0 of API by regulatory authority of Tecaglore: Firm has submitted copy of GMP
country of origin or GMP certificate of API Certificate of manufacturer Nantong Chanyoo
manufacturer issued by regulatory authority of Pharmatech Co., Ltd, China, address: No.2, Tonghai
country of origin. Si Road, Yangkou chemical industrial park, Rudong
coastal economic development zone, Nantong
Jiangsu province 226407, PR china valid till 3-nov-
2018
Yes
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested invoice provided
for 0.1 kg of Ticagrelor provided in which issuer is
Changzhou pharmaceuticals factory no. 2 cailing
road Changzhou Jiangsu chaina
sign and stamp) for ensuring authenticity of data Yes
/ documents.
Yes
Yes
Rules, 1978.
1. Reference of last onsite  Registration Board approved Nisita Tablets 60 mg and Vibrenta
panel inspection for instant tablet 400/100 mg in its 279 Meeting.
dosage form conducted o Date of Inspection: 19-02-2017.
during last two years. o The HPLC is 21CFR Compliant.
o Audit trail on the testing were available.
2. Documents for the Tecaglore: The firm has submitted photocopies of ADC (Karachi)
procurement of API with attested Form 6 dated 05-12-2017, Commercial Invoice attestation on
approval from DRAP (in dated 22/2/18 for 0.1 kg of Tecaglore. Batch # TGL-160301 from
case of import). Changzhou pharmaceuticals factory No. 2 cailing road Changzhou
Jiangsu chaina
3. Documents for the  The firm has submitted analytical reports/COA of reference
procurement of reference standard & impurity standards.
standard and impurity  The firm has clarified that the reference standard and impurity
standards. standards are provided free of cost along with the APIs’ consignment
and not separately by Nantong chanyoo.
4. Approval of API/ The Firm has submitted copy of GMP Certificate of manufacturer
DML/GMP certificate of “Nantong Chanyoo Pharmatech Co., Ltd, China, address: No.2, Tonghai
API manufacturer issued Si Road, Yangkou chemical industrial park, Rudong coastal economic
by regulatory authority of development zone, Nantong Jiangsu province 226407, PR china.
country of origin.
5. Mechanism for Vendor  The firm has submitted copy of vender evaluation questionnaire
pre-qualification for vender pre-qualification along with filled questionnaire from both
APIs manufacturers.
6. Certificate of analysis of  Tecaglore API:
the API, reference Photocopy of COA of Batch No. TGL-160301 issued by “M/s Nantong
standards and impurity Chanyoo Pharmaceutical Co., Ltd. China” is submitted.
standards
The firm has submitted copy of Working Standards and impurity
standards provided by the API Manufacturer
7. Documents for the Firm has submitted copy of commercial invoices for the excipients used
procurement of excipients in the applied formulation.
used in product
development?
8. List of qualified staff Firm has submitted copy of R&D staff list.2 pharmacists and 2 BSC are
involved in product present in there R &D
development with relevant
experience.
Production Data
9. Authorized Protocols/SOP The firm has submitted copy of SOP with the title ‘Product
for the development & Development Protocols’.
stability testing of trial Effective date 28-02-2017.
batches.
10. Complete batch The firm has submitted copy of Trial batch manufacturing record.
manufacturing record of Details are as under:
three stability batches. Experta Tablet 90 mg
Batch No. Bach size Mfg.
Started
TR001/EXP 250 Tabs 2-2017
TR002/EXP 250 Tabs 2-2017
TR003/EXP 250 Tabs 2-2017
11. Record of remaining
quantities of stability  TR001: Batch Size : 250 Tablets
batches. Remaining: 42 tablets
QA/QC DATA
12. Record of Digital data The firm has submitted copy of record of digital data logger (Logit
logger for temperature and Chart, Technoman) for temperature and humidity monitoring of stability
humidity monitoring of chambers.
stability chambers (real
time and accelerated)
13. Method used for analysis  The firm has submitted photocopy of method used for analysis
of API along with COA. of APIs along with COA.
14. Method used for analysis  The firm has submitted photocopy of Finished Product
of FPP & complete record Specifications and Testing Method of Complete record of testing of
of testing of stability stability batches (i.e. chromatograms, lab reports, raw data sheets etc.)
batches (i.e. are submitted with 06 months stability data (Accelerated) & Real Time.
chromatograms, lab
reports, raw data sheets
etc.)
15. Reports of stability studies Tacagrelor: The firm has submitted copy of accelerated, 06 Months
of API from manufacturer. (40°C ± 2°C & 75±5%RH) & long term, 12 Months (25°C ± 2°C &
60±5%RH) stability study reports of 03 batches
16. Analysis reports for The firm has submitted copy of COAs for the excipients used in the
excipients used. applied formulation.
17. Drug-excipients  The firm has not submitted Drug-excipients compatibility
th
| 737
compatibility studies. studies and has referred to the Innovator Product (Brilinta).
18. Record of comparative  Firm has submitted Comparative dissolution study of their
dissolution data. product with Innovator’s Brand “ Brilinta” conducted on following
dates ;
 The details are as follows:
Product Tabross Pharma
Brand name Brilinta Experta Tablet 90
Tablets mg
90 mg
Mfg. date Not mentioned 2-2017
Medium 0.2% w/v tween 80 in water
RPM 75
19. Compliance Record of The firm has submitted copy of Audit Trail for march 2018 to august
HPLC software 21CFR & 208, but the data from Feb 2017-feb 2018 were un-retrievable from the
audit trail reports on system but firm claim to have hard copies of chromatograms
product testing.
Evaluation by PEC:
On commercial invoice Firm provided the statement by Changzhou
different manufacturer was pharmaceuticals factory declare that Nantong chanyoo
mentioned. On commercial pharmatech Co.Ltd located No 2 tonghai Sirod Yangkou
invoice Changzhou chemicals industrial park, rudong coastal economic
pharmaceutical is mentioned development zone, Nantong Jiangsu province 226407,
and GMP provided is of PR China is our wholly owned subsidiary.
Nantong Jiangsu
Stability of API ticaglerol is Manufacturer has started stability study at zone IV-A
at 25°C ± 2°C & 60±5%RH conditions and completed 1 month stability data. And
undertake to provide 12 month real time stability
The GMP certificate of Valid GMP is provided, valid up to 7/9/2020
Nantong Jiangsu is valid till
November 2018, provide
valid GMP
Comparative dissolution is Dissolution is performed on 3 mediums at 4.5, 1.2 and
not performed according to 6.8 on fresh trail batch, dissolution was performed at 5,
recommended methods on 3 10, 15,20, 30, 45 and 60 minutes.
pH medium.
Exact polymorphic form
could not be verified as no
data of types of polymorphic
forms available/provided by
the firm and it’s not possible
to precisely identify the
stable polymorphic form of
Ticagrelor.
Decision:
Evaluator PEC-VIII
1243. Name and address of M/s. Atco Laboratories Limited, B-18, S.I.T.E, Karachi.
Brand Name +Dosage Form + Advacort 0.1% Lotion
Strength
Methyl prednisolone aceponate….1mg
Diary No. Date of R& I & fee Dy No. 127; 14-10-2010
Pharmacological Group Alpha-adrenoreceptor antagonists/Muscarinic Antagonist.
Pack size & Demanded Price 30ml, 60ml : Rs. 225/-, Rs. 330/-,
Approval status of product in Approved in TGA
dosage form)
GMP status
Decision: Deferred for the following:
1. Confirmation of manufacturing facility for steroids.
2. Stability studies as per ICH/ WHO guidelines.
3. Clinical trial data along with clinical justification.
Previous Decision: Registration Board in its 246th meeting deferred the case
for the following:
1. Confirmation of manufacturing facility for steroids.
2. Stability studies as per ICH/ WHO guidelines.
3. Clinical trial data along with clinical justification.
Evaluation By PEC: Now the firm has submitted the following:
 Stability studies data for the applied formulation &
claimed Exemption from onsite investigation of
stability studies.
 Applied drug Product is approved in TGA.
Drug Advacort 0.1% Lotion
Name of Manufacturer M/s. Atco Laboratories Limited, B-18, S.I.T.E, Karachi.
Manufacturer of API Methyl Prednisolone Aceponate:
M/s SymbioticaSpeciality Ingredients SDN, BHD, Malaysia
API Lot No. Methyl Prednisolone Aceponate:
Description of Pack
HDPE Bottles
Conditions of zone Ivb
Accelerated:06Months
Frequency Real Time: Initial,3,6 Months(on going)
Accelerated: Initial,1,2,3,4,6 Months
Batch No. 152F17 153F17 154F17
Batch Size 800gm 800gm 800gm
No. of Batches 03
Date of Submission Dy No. 34108 : 15-10-18
No.
3. COA of API
Yes
4. Approval of API by regulatory authority of country The firm has submitted photocopy of GMP
of origin or GMP certificate of API manufacturer certificate issued by National Pharmaceutical
issued by regulatory authority of country of origin. Regulatory Agency, Ministry Of Health Malaysia,
valid till 19thApril 2019.
documents.
1978.
Reference of last onsite panel inspection Drug Registration Board approved Nonit Lotion 0.5%
for instant dosageform conducted during (Ivermectin) in its 284th Meeting on the basis of inspection
01 last two years. conducted on 26th of July, 2018 which confirms
following:
 HPLC software is 21CFR Compliant as per record
available with firm.
 Audit trail reports on testing are available &
verifiable.
 Adequate monitoring & control are available for
stability chambers.
But same inspection does not confirm the existence of
digital data logger with the firm, however; applicant has
submitted temperature & humidity record of stability
chambers recorded with digital data logger.
02 Documents for the procurement of API The firm has submitted photocopy of ADC (Karachi)
with approval from DRAP (in case of attested dated 16-05-2017, Commercial Invoice dated 05-
import). 05-2017 for 1.0kg Methyl Prednisolone
Aceponate.Commercial Invoice is issued by M/s
SymbioticaSpeciality Ingredients SDN, BHD, Malaysia.
03 Documents for the procurement of The firm has submitted photocopy of Invoice dated 14-05-
reference standard and impurity standards 2017 for 100mg Methyl Prednisolone Aceponate working
standard.
The firm has submitted the photocopy of invoice dated
27.02.2018 for 10mg each of following impurity standards
 Methyl prednisolone
 Methyl prednisolone-21-acetate
 Methyl prednisolone-17-propionate
 Methyl prednisolone-21-propionate
 Methyl prednisolone-17-propionate-11, 21-
diacetate
04 GMP/DML certificate of API The firm has submitted photocopy of GMP certificate
manufacturer. issued by National Pharmaceutical Regulatory agency,
ministry of Health Malaysia, valid till 19th April 2019.
05 Mechanism for Vendor pre-qualification The firm has submitted copy of API Management and
Acceptance Policy
06 Certificate of analysis of the API, Photocopy of COAs of methyl prednisolone aceponate, of
reference standards and impurity the, reference standards and impurity standards issued
standards by M/s SymbioticaSpeciality Ingredients SDN, BHD,
Malaysia is submitted. Detail is as under
Particulars Batch No.
Methyl prednisolone 19
aceponate
Methyl prednisolne WS/MBP/0217
Methyl prednisolone WS/methyl
acetate prednisolone/21/acetate/1
116
Methyl prednisolone- WS/methyl
17-propionate prednisolone/17/propiona
te/1116
21-propionate prednisolone/21/propiona
te/1116
17-propionate-11, 21- prednisolone/17/propiona
Diacetate te-11, 21-Diacetate/0516
07 Documents for the procurement of Firm has submitted copy of commercial invoices for the
08 List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience staff involved in product development/Scientific
development & Analytical Services comprising of total 23
members.
Production Data
09 Authorized Protocols/SOP for the The firm has submitted photocopy of Product
development & stability testing of trial Development Protocol(SOP referenceNo.
batches. PDD/PP/PD/001) filled for Advacort lotion 0.1%, dated
13-04-2017, which also includes stability protocol.
Complete batch manufacturing record of The firm has submitted photocopy of BatchManufacturing
10 three stability batches Record of the following 03 Batches of Advacort 0.1%
lotion:
Batch No. Batch Size Mfg date
152F17 800g 20.06.2017
153F17 800g 20.06.2017
154F17 800g 21.06.207
Record of remaining quantities of stability The firm has reconciliation sheets mentioning details of all
11 batches. three trial batches of Advacort 0.1% Lotion.
QC/ QA DATA
Record of Digital data logger for The firm has submitted digital temperature and humidity
12 temperature and humidity monitoring of monitoring record for accelerated and long term
stability chambers (real time and conditions from July2017 to Jan 2018.
accelerated)
13 Method used for analysis of API along The firm has submitted photocopy of raw
withCOA. materialspecifications, raw material testing procedures
along with COA for methyl prednisolone aceponate
(Batch MPAP004/0816) from ATCO laboratories limited
and M/s SymbioticaSpeciality Ingredients SDN, BHD,
Malaysia.
14 Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Specifications and Testing Method for Advacort 0.1%
batches (i.e. chromatograms, lab reports, Lotion.
raw data sheets etc.) Complete record of testing of stability batches 152F17,
153F17 and 154F17 (i.e. chromatograms, lab reports, raw
data sheets etc.) are submitted with the stability data.
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, 60 Months (30°C
± 2°C & 65±5%RH) stability study reports of 03 batches
of Methyl Prednisolone Aceponate from M/s
SymbioticaSpeciality Ingredients SDN. BDH, Malaysia.
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 submitted the Drug excipients compatibility
study report.
18 Record of comparative dissolution data. Due to semisolid topical dosage form, its CDP is not
required.
19 Compliance Record of HPLC The firm has submitted copy of Audit Trail for Initial,
software21CFR & audit trail reports on 1st3rd and 6th Month Testing Intervals of Advacort 0.1%
product testing. Lotion.
Sr. Question By PEC Response By Firm
No
.
1 Clarification is required whether We would like to inform that we are evaluating our
stability studies of applied formulation products is astringent condition zone i.e.
are conducted in accordance with either Accelerated 400 C + 20 C / 75% RH +5%RH
zone IVa or IVb conditions, as Long term 300 C + 20 C / 75% RH + 5%RH
conditions mentioned on stability As we are an exporting country and also export in
summary sheets are of zone IVb. ASEAN countries, which require stability studies of
product in zone IVb so we are doing same for our local
produts.
Stability studties of product for accelerated condition
conducted at temperature 40 +20C and RH 75+ 5%
whereas long term stability studies are conducted at 30+
2 % and RH 75+ 5% that has been submitted.
Furthermore, it can also be verified by temperature
monitering record of stability chambers already
submitted.
2 Batch number of API is not mentioned Batch number of API in not mentioned on commercial
on the commercial invoice. How did you invoice but mentioned in packing list. Packing list and
come to know about the batch number of invoice can be related with invoice number along with
API. contract number and its date that is 117/0378 and
0071IRC007833 dated 05/04/2017 respectively. Related
documents are being attached and stated information is
highlighted for your convenience. Find in annexure 02.
3 Did you use analytical method of either It is to inform that we are using our own developed
supplier or your in house & have you method that is extracted from supplier’s method for our
performed method validation studies if product. Analytical method validation is performed and
yes, than submit the data. If No, than report is attached for review in annexure 03.
clarify/justify. With this submission we hope to suffice your
requirements and request you to include our subject
products in the agenda of upcoming drug Registrant
Board meeting for the grant of approval of registration.
4 COA of HPMC 2910 is not submitted. It is to clarify that COA of HPMC 2910 has been
submitted. However, COA is being submitted again for
your review in Annexure 01.
Decision:
Evaluator PEC-XII
Group,
Finished Product
Specification
1244. M/s Jenner Dapajen 5mg Form 5-D FARXIGA film coated
Pharmaceuticals (Pvt) Tablet tablets 5mg by M/s
Ltd, Dairy No. 1270 dated Astrazeneca AB (USFDA
Each film coated 28-11-2016. approved)
Plot no. 2, M-2 Pharma tablet contains: Rs.50,000/- dated 28-11-
Zone, 28-km Lahore Dapagliflozin 2016.(Challan#0565607) Last GMP inspection
Sharaqpur Road, District propanediol conducted on 06.11.2017
Sheikhupura. monohydrate eq to As per SRO / 14’s. and the report concludes
dapagliflozin…… that overall the condition
….5mg of firm is satisfactory.
Blood glucose
lowering drugs,
excl. insulins
(Sodium-glucose
co-transporter 2
(SGLT2) inhibitors)
Manufacturer’s
Specifications.
Drug Dapajen 5mg Tablet (Dapagliflozin propanediol monohydrate)
Name of Manufacturer M/s Jenner Pharmaceuticals (Pvt) Ltd.
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co., Ltd.
Fluoride Industrial Park, Fuxin City, Liaoning Province – 123000, China.
API Lot No. 160901
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Frequency Accelerated: 0,1,2,3,4,5,6 (months)
Batch No. DAP-PB-008001 DAP-PB-008002 DAP-PB-008003
No. of Batches 03
No.
9. COA of API  Method used for analysis of API along with
copy of COA for dapagliflozin propanediol
monohydrate from M/s Fuxin Long Rui
Pharmaceutical Co., Ltd. has been submitted.
10. Approval of API by regulatory authority of  Approval of DML of Fuxin Long Rui
country of origin or GMP certificate of API Pharmaceutical Co., Ltd. (Certificate number
manufacturer issued by regulatory authority of Liao 20150233) valid till 20-12-2022 confirmed.
country of origin.  Weblink:
http://app1.sfda.gov.cn/datasearcheng/face3/bas
e.jsp?tableId=85&tableName=TABLE85&title=
Database%20of%20approved%20Active%20Ph
armaceutical%20Ingredients%20(APIs)%20and
%20API%20manufacturers%20in%20China&bc
Id=136489131226659132460942000667
Accessed on 22-01-2019.
Yes
13. Documents confirming import of API etc.  Firm has submitted ADC attested copy dated 20-
03-2017 confirming import of 175 grams of
Dapagliflozin propanediol monohydrate.
Batch no. not mentioned on invoice
Invoice no. HK 1701121-B
 Firm has submitted copy of Form-3 confirming
import of API from M/s Fuxin Long Rui
Pharmaceutical Co., Ltd.
batch no of API i.e. 160901.
data / documents.
Yes
Rules, 1978.
instant dosage form conducted during last product “Lansodex Capsule 60mg and 30 mg,
two years. Sofopas Tablet 400/90 and 400 mg)”, which was
conducted on 10-12-2018 and was presented in 287th
Meeting of Registration board. Registration Board
decided to approve registration of Lansodex Capsule
60mg and 30 mg, Sofopas Tablet 400/90 and 400
mg of M/s Jenner Pharmaceuticals (Pvt) Ltd,.
Sheikupura.
 According to the report generated following
points were confirmed
a) The firm has complete record of qualification of
equipment / instruments used for test and
analysis of API and Sobovir Tablets 400mg.
b) The HPLC used for analysis of stability batches
is Shimadzu 20 ATVP with auto sampler and
gradient system and it was 21 CFR compliant.
c) The firm has demonstrated the audit trail reports
for the data submitted for Sobovir Tablets
400mg.
d) The firm has valid calibration status for all the
equipments/ instruments used in production and
analysis of the Sobovir Tablets 400mg.
e) The firm has two separate Memmert (Germany)
stability chambers for Real Time and Accelerated
stability studies which are equipped with data
loggers. For continuous power supply solar
panels were installed Firm was advised to
completely follow SOPs for continuous
monitoring of stability chambers. Firm was also
advised to use the installed alarm system more
effectively.
f) Firm has dedicated area for product
development, and all manufacturing area,
equipment, personnel seemed to conform to a
satisfactory level of cGMP compliance on the
day of inspection.
2. Documents for the procurement of API with  Firm has submitted ADC attested copy dated 20-
approval from DRAP (in case of import). 03-2017 confirming import of 175 grams of
3. Documents for the procurement of reference  Firm has not submitted documents for
standard and impurity standards. procurement of reference and impurity standards.
 Quantity of working standard imported by the
firm is not confirmed.
4. Approval of API/ DML/GMP certificate of  Approval of DML of Fuxin Long Rui
API manufacturer issued by regulatory Pharmaceutical Co., Ltd. (Certificate number
authority of country of origin. Liao 20150233) valid till 20-12-2022 confirmed.
 Weblink:
http://app1.sfda.gov.cn/datasearcheng/face3/base.
jsp?tableId=85&tableName=TABLE85&title=D
atabase%20of%20approved%20Active%20Phar
maceutical%20Ingredients%20(APIs)%20and%2
0API%20manufacturers%20in%20China&bcId=
136489131226659132460942000667
5. Mechanism for Vendor pre-qualification  Firm has submitted vendor evaluation form
which is filled by the applicant i.e. M/s Jenner
Pharmaceuticals (Pvt) Ltd.
6. Certificate of analysis of the API, reference  Certificate of analysis of the API, working
standards and impurity standards standard and impurity standard submitted by the
firm.
7. Documents for the procurement of  Firm has submitted documents for procurement
excipients used in product development? of excipients used in product development.
8. List of qualified staff involved in product  Firm has submitted list of 2 qualified person
development with relevant experience. working in product development section.
Production Data
9. Authorized Protocols/SOP for the  Firm has submitted SOP for product design and
development & stability testing of trial development protocol (document # PDP-STB-
batches. 008) of Dapajen Tablet 5mg.
 Firm has submitted SOPs for stability study
protocol. (document # JP/SSP/008) of Dapajen
Tablet 5mg
10. Complete batch manufacturing record of  Firm has provided complete batch manufacturing
three stability batches. record of all the three batches
11. Record of remaining quantities of stability Batch No Total no. Tablets Remaining
batches. of used for Quantities
Tablets testing of tablets
placed in
stability
chamber
DAP-PB- 854 336 520
008001
DAP-PB- 854 336 520
008002
DAP-PB- 854 336 520
008003
QA/QC DATA
12. Record of Digital data logger for  Firm has submitted record of digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring control
stability chambers (real time and for the complete stability period.
accelerated)  For accelerated stability study the time period
was from 25-04-2018 to 03-12-2018.
 For real time stability study the time period was
from 25-04-2018 to 03-12-2018.
13. Method used for analysis of API along with  Method used for analysis of API along with copy
COA. of COA for dapagliflozin propanediol
 Firm has submitted own analytical record i.e.
method of analysis, lab report, raw data sheets,
chromatograms for the analysis of Dapagliflozin
propanediol monohydrate (batch# 160901).
14. Method used for analysis of FPP &  Firm has provided method used for analysis of
complete record of testing of stability FPP
raw data sheets etc.) stability batches including chromatograms, lab
reports and raw data sheets
15. Reports of stability studies of API from  Firm has submitted summary sheet of 3 batches
manufacturer. of API conducted at 30°C ± 2°C / 65% ± 5%RH
for long term for 36 months and 40°C ± 2°C /
75% ± 5%RH for accelerated studies for 6
months.
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.  Submitted by the firm.
18. Record of comparative dissolution data. Firm has submitted comparative Dissolution studies
report. The details of reference product & Sample
product are as follows:
Feature Reference Reference
product product
Product of M/s
Hilton
Brand name Forxiga Dapajen
Tablets 5mg Tablets 5mg
Batch# AAK 7311 DPA-PB-
008001
Comparative dissolution studies have been

 i. Acetate buffer pH 4.5
19. Compliance Record of HPLC software Firm has submitted audit trail reports of stability
testing.
Evaluation by PEC:
Decision:
Group,
Finished Product
Specification
1245. M/s Jenner Dapajen 10mg Form 5-D FARXIGA film coated
Pharmaceuticals (Pvt) Tablet tablets 10mg by M/s
Ltd, Dairy No. 1269 dated Astrazeneca AB (USFDA
Each film coated 28-11-2016. approved)
Plot no. 2, M-2 Pharma tablet contains: Rs.50,000/- dated 28-11-
Zone, 28-km Lahore Dapagliflozin 2016.(Challan#0565606) Last GMP inspection
Sharaqpur Road, District propanediol conducted on 06.11.2017
Sheikhupura. monohydrate eq to As per SRO / 14’s. and the report concludes
dapagliflozin…… that overall the condition
….10mg of firm is satisfactory.
Blood glucose
lowering drugs,
excl. insulins
(Sodium-glucose
co-transporter 2
(SGLT2) inhibitors)
Manufacturer’s
Specifications.
Drug Dapajen 10mg Tablet (Dapagliflozin propanediol monohydrate)
Name of Manufacturer M/s Jenner Pharmaceuticals (Pvt) Ltd.
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co., Ltd.
Fluoride Industrial Park, Fuxin City, Liaoning Province – 123000, China.
API Lot No. 160901
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 6 months
Frequency Accelerated: 0,1,2,3,4,5,6 (months)
Batch No. DAP-PB-009001 DAP-PB-009002 DAP-PB-009003
No. of Batches 03
No.
1. COA of API  Method used for analysis of API along with
copy of COA for dapagliflozin propanediol
2. Approval of API by regulatory authority of  Approval of DML of Fuxin Long Rui
country of origin or GMP certificate of API Pharmaceutical Co., Ltd. (Certificate number
manufacturer issued by regulatory authority of Liao 20150233) valid till 20-12-2022 confirmed.
country of origin.  Weblink:
http://app1.sfda.gov.cn/datasearcheng/face3/bas
e.jsp?tableId=85&tableName=TABLE85&title=
Database%20of%20approved%20Active%20Ph
armaceutical%20Ingredients%20(APIs)%20and
%20API%20manufacturers%20in%20China&bc
Id=136489131226659132460942000667

Yes
5. Documents confirming import of API etc.  Firm has submitted ADC attested copy dated 20-
03-2017 confirming import of 175 grams of
data / documents.
Yes
Yes
Rules, 1978.
instant dosage form conducted during last product “Lansodex Capsule 60mg and 30 mg,
two years. Sofopas Tablet 400/90 and 400 mg)”, which was
conducted on 10-12-2018 and was presented in 287th
Meeting of Registration board. Registration Board
decided to approve registration of Lansodex Capsule
60mg and 30 mg, Sofopas Tablet 400/90 and 400
mg of M/s Jenner Pharmaceuticals (Pvt) Ltd,.
Sheikupura.
 According to the report generated following
points were confirmed
g) The firm has complete record of qualification of
equipment / instruments used for test and
analysis of API and Sobovir Tablets 400mg.
h) The HPLC used for analysis of stability batches
is Shimadzu 20 ATVP with auto sampler and
gradient system and it was 21 CFR compliant.
i) The firm has demonstrated the audit trail reports
for the data submitted for Sobovir Tablets
400mg.
j) The firm has valid calibration status for all the
equipments/ instruments used in production and
analysis of the Sobovir Tablets 400mg.
k) The firm has two separate Memmert (Germany)
stability chambers for Real Time and Accelerated
stability studies which are equipped with data
loggers. For continuous power supply solar
panels were installed Firm was advised to
completely follow SOPs for continuous
monitoring of stability chambers. Firm was also
advised to use the installed alarm system more
effectively.
l) Firm has dedicated area for product
development, and all manufacturing area,
equipment, personnel seemed to conform to a
satisfactory level of cGMP compliance on the
day of inspection.
2. Documents for the procurement of API with  Firm has submitted ADC attested copy dated 20-
approval from DRAP (in case of import). 03-2017 confirming import of 175 grams of
3. Documents for the procurement of reference  Firm has not submitted documents for
standard and impurity standards. procurement of reference and impurity standards.
 Quantity of working standard imported by the
firm is not confirmed.
4. Approval of API/ DML/GMP certificate of  Approval of DML of Fuxin Long Rui
API manufacturer issued by regulatory Pharmaceutical Co., Ltd. (Certificate number
authority of country of origin. Liao 20150233) valid till 20-12-2022 confirmed.
 Weblink:
http://app1.sfda.gov.cn/datasearcheng/face3/base.
jsp?tableId=85&tableName=TABLE85&title=D
atabase%20of%20approved%20Active%20Phar
maceutical%20Ingredients%20(APIs)%20and%2
0API%20manufacturers%20in%20China&bcId=
136489131226659132460942000667
5. Mechanism for Vendor pre-qualification  Firm has submitted vendor evaluation form
which is filled by the applicant i.e. M/s Jenner
Pharmaceuticals (Pvt) Ltd.
6. Certificate of analysis of the API, reference  Certificate of analysis of the API, working
standards and impurity standards standard and impurity standard submitted by the
firm.
7. Documents for the procurement of  Firm has submitted documents for procurement
excipients used in product development? of excipients used in product development.
8. List of qualified staff involved in product  Firm has submitted list of 2 qualified person
development with relevant experience. working in product development section.
Production Data
9. Authorized Protocols/SOP for the  Firm has submitted SOP for product design and
development & stability testing of trial development protocol (document # PDP-STB-
batches. 009) of Dapajen Tablet 5mg.
 Firm has submitted SOPs for stability study
protocol. (document # JP/SSP/009) of Dapajen
Tablet 5mg
10. Complete batch manufacturing record of  Firm has provided complete batch manufacturing
three stability batches. record of all the three batches
11. Record of remaining quantities of stability Batch No Total no. Tablets Remaining
batches. of used for Quantities
placed in
stability
chamber
DAP-PB- 854 336 518
009001
DAP-PB- 854 336 518
009002
DAP-PB- 854 336 518
009003
QA/QC DATA
12. Record of Digital data logger for  Firm has submitted record of digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring control
stability chambers (real time and for the complete stability period.
accelerated)  For accelerated stability study the time period
was from 25-04-2018 to 03-12-2018.
 For real time stability study the time period was
from 25-04-2018 to 03-12-2018.
13. Method used for analysis of API along with  Method used for analysis of API along with copy
COA. of COA for dapagliflozin propanediol
 Firm has submitted own analytical record i.e.
method of analysis, lab report, raw data sheets,
chromatograms for the analysis of Dapagliflozin
propanediol monohydrate (batch# 160901).
14. Method used for analysis of FPP &  Firm has provided method used for analysis of
complete record of testing of stability FPP
raw data sheets etc.) stability batches including chromatograms, lab
reports and raw data sheets
15. Reports of stability studies of API from  Firm has submitted summary sheet of 3 batches
manufacturer. of API conducted at 30°C ± 2°C / 65% ± 5%RH
for long term for 36 months and 40°C ± 2°C /
75% ± 5%RH for accelerated studies for 6
months.
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.  Submitted by the firm.
18. Record of comparative dissolution data. Firm has submitted comparative Dissolution studies
report. The details of reference product & Sample
product are as follows:
Feature Reference Reference
product product
Product of M/s
Hilton
Brand name Forxiga Dapajen
Tablets 10mg Tablets 10mg
Batch# AAS 2301 DPA-PB-
009001
Comparative dissolution studies have been

 i. Acetate buffer pH 4.5
19. Compliance Record of HPLC software Firm has submitted audit trail reports of stability
testing.
Evaluation by PEC:
Decision:
Evaluator PEC-XIV
Sr. Name & Brand Name Type of Form, International Remarks
No. Address of (Proprietary Name Initial Diary & Availability /
Manufacturer / + Dosage Form + Date, Fee Local
Applicant Strength), (including Availability
Finished Product
Specification
1246. M/s. Hilton Vasac 24/26mg Form 5 Entresto Tablet of
Pharma (Pvt.) Tablets Novartis pharms,
Ltd. Plot 13/14, Dairy No.468 USFDA
Sector 15, Each film coated dated 17-09-2015
Korangi tablet contains Sacuvan tablets
Industrial Area, Sacubitril….….24mg Rs.50,000/- dated 24/26mg of GETZ
Karachi Valsartan....….26mg 17-09-2015 pharma
Neprilysin Inhibitor 10’s, 30’s, 60’s; As Sovel Tablets of

And Angiotensin II per DPC 24/26mg of
receptor blocker Alu-Alu Blister pharmEvo
Manufacturer’s GMP Inspection

specification conducted on 24-
01-2018
concluded that the
firm was
operating at a very
good level of
GMP compliance
at the time of
inspection.
Drug Vasac 24/26mg Tablets
Name of Manufacturer M/s. Hilton Pharma (Pvt.) Ltd. Plot 13/14, Sector 15, Korangi Industrial Area,
Karachi
Manufacturer of API M/s. Nantong Chanyoo Pharmatech Co., Ltd, China
API Lot No. 201701001
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 6 months
Frequency Accelerated: 0,3,6 (months)
Batch No. VAS-250807-1 VAS-250907-2 VAS-251007-3
No. of Batches 03
No.
1. COA of API. Copy of COA (Batch #201701001) from M/s.
Nantong Chanyoo Pharmatech Co., Ltd, China is
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate (Certificate No. 2017006)
country of origin or GMP certificate of API issued by Nantong food and Drug Administration,
manufacturer issued by regulatory authority China. It is valid until 07-09-2020.
of country of origin.

sheets etc.
for the procurement of Sacubitril+valsartan
Trisodium Hemipentahydrate (LCZ696) 4.0 kg
attested by ADC, DRAP, Karachi dated 09-01-
2017.
Rules, 1978.
● The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data for 03 Batches.
provided the following documents in conjunction with the checklist approved by the Registration Board in its
278th Meeting:
Date of submission: 30-12-2018 vide diary no. 39548
1. Reference of last onsite panel inspection for Firm has referred to last onsite inspection of their
instant dosage form conducted during last two product HILVEL Tablets (Sofosbuvir / Velpatasvir)
years. which was considered and approved by Registration
Board in its 277th Meeting with following details:
 Date of Inspection: 14-12-2017.
 Audit trail on the testing reports were available.
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 procurement of Sacubitril+valsartan Trisodium
Hemipentahydrate (LCZ696) 4.0 kg attested by ADC,
DRAP, Karachi dated 09-01-2017.
3. Documents for the procurement of reference The firm has submitted copies of invoices from M/s
standard and impurity standards. Neon Chemicals working standards and impurity
standards.
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate (Certificate No. 2017006)
API manufacturer issued by regulatory issued by Nantong food and Drug Administration,
authority of country of origin. China. It is valid until 07-09-2020.
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 #201701001) from M/s.
standards and impurity standards Nantong Chanyoo Pharmatech Co., Ltd, China is
submitted.
submitted
 COAs of impurity standards have been submitted.
used in product development? invoices/COAs of the excipients used in the
development with relevant experience. in product development department.
Production Data
development & stability testing of trial for the Development of VASAC 24/26mg film coated
batches. tablets”.
stability batches. Manufacturing Records of following 03 Batches:
Batch No. Batch Size Mfg. Date
VAS-250807-1 7000 tablets 06-07-2017
VAS-250907-2 7000 tablets 06-07-2017
VAS-251007-3 7000 tablets 06-07-2017
11. Record of remaining quantities of stability
batches. Trial No Total no. of Remaining
Tablets Quantities of
For stability tablets
testing
VAS-250807-1 7000 tablets 80 tablets
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of digital data logger
and humidity monitoring of stability chambers record for Accelerated stability chamber and Real
(real time and accelerated) Time stability chamber starting from 01-07-2017 to
27-01-2018.
COA. Specifications, Raw Material Testing Procedures along
with COAs for Sacubitril/Valsartan trisodium
hemipentahydrate.
record of testing of stability batches (i.e. Testing Procedure for “Vasac 24/26mg tablets” along
chromatograms, lab reports, raw data sheets with Stability Study Reports.
etc.)
Data of 03 Batches of Sacubitril/Valsartan Complex
(LCZ696) from M/s Nantong Chanyoo, China.
17. Drug-excipients compatibility studies. The firm has submitted that
“We are using the same qualitative formulation as
innovator is using. Our stability studies also have not
shown any incompatibility or significant degradation.”
studies in three media including pH 1.2, pH 4.5 and pH
6.8 buffers with Entresto Tablets 24/26mg
manufactured by M/s. Novartis Pharmaceuticals,
Canada with Batch TK818. The firm‘s product results
are comparable with Entresto 24/26mg Tablet.
19. Compliance Record of HPLC software 21CFR The firm has submitted audit trail reports of Vasac
& audit trail reports on product testing. 24/26mg tablet for the testing time points.
Testing frequency of accelerated stability study data is not as per 278th meeting of Registration. Clarification
is required.
Decision:
Finished Product
Specification
Industrial Area, Sacubitril….….49mg Rs.50,000/- dated 49/51mg of GETZ
Karachi Valsartan....….51mg 17-09-2015 pharma

01-2018
concluded that the
firm was
operating at a very
good level of
GMP compliance
at the time of
inspection.
Karachi
API Lot No. 201701001
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 6 months
No. of Batches 03
No.
submitted.

sheets etc.
2017.
Rules, 1978.
278th Meeting:
standards.
qualification.
submitted.
submitted
Production Data
VAS-249706-3 3500 tablets 06-07-2017
VAS-249806-4 3500 tablets 06-07-2017
VAS-249906-5 3500 tablets 06-07-2017
testing
VAS-249706-3 3500 80
VAS-249806-4 3500 80
VAS-249906-5 3500 80
QA / QC DATA
27-01-2018.
hemipentahydrate.
etc.)
is required.
Decision:
Finished Product
Specification
Industrial Area, Sacubitril….….97mg Rs.50,000/- dated 97/103mg of
Karachi Valsartan....….103mg 17-09-2015 GETZ pharma


01-2018
concluded that the
firm was
operating at a very
good level of
GMP compliance
at the time of
inspection.
Karachi
API Lot No. 201701001
Real Time: 30°C ± 2°C/65%±5% RH
Real Time: 6 months
No. of Batches 03
No.
submitted.

sheets etc.
2017.
Rules, 1978.
278th Meeting:
standards.
qualification.
submitted.
submitted
Production Data
VAS-249006-5 2000 tablets 06-07-2017
VAS-249206-6 2000 tablets 06-07-2017
VAS-249306-7 2000 tablets 06-07-2017
testing
VAS-249006-5 2000 80
VAS-249206-6 2000 80
VAS-249306-7 2000 80
QA / QC DATA
27-01-2018.
hemipentahydrate.
etc.)
is required.
Decision:
Finished Product
Specification
1249. M/s Barrett HEPGARD-V Form 5 Epclusa of Gilead
Hodgson TABLETS 400MG + Sciences, USA
Pakistan (Pvt) 100 MG Dairy No.1758 (USFDA
Ltd. dated 01-09-2016 approved)
F/423,S.I.T.E. Each film coated
Karachi. tablet contains: Rs.50,000/- dated
Sofosbuvir…………. 01-09-2016 N/A
400mg
Velpatasvir………… Pack of 10’s Rs.
100mg 28,000/-, Last GMP
Pack of 14’s Rs. inspection Dated
Direct Acting 39,200/-, 16th-28th August
Antiviral agents Pack of 20’s Rs. 2018 concluded
against Hepatitis C 56,000/- that overall firm
virus Pack of 28’s Rs. was found
78,400/- satisfactory and
Manufacturer’s Pack of 30’s Rs. progressive
Specifications. 84,000/- towards good
Alu-Alu Blister level of GMP
compliance.

Drug Hepgard-V Tablets 400mg + 100mg
Name of Manufacturer M/s Barrett Hodgson Pakistan (Pvt) Ltd., F/423,S.I.T.E., Karachi.
Manufacturer of API Sofosbuvir: M/s Nantong Chanyoo Pharmatech Co., Ltd, China
Velpatasvir-Co-Povidone: M/s Nantong Chanyoo Pharmatech Co., Ltd,
China
API Lot No. Sofosbuvir: RD-SFB (Form-VI)-201701201
Velpatasvir-Co-Povidone: 201703001
Description of Pack High Density Polyethylene (HDPE) bottles
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 0, 4, 12, 26 weeks
Real Time: 0, 12, 26 weeks
Frequency Accelerated: 26 (weeks)
Batch No. PLT-T-075 EXP-T-917 PLT-T-076
No. of Batches 03
No.
1. COA of API. Sofosbuvir: Copy of COA (Batch# RD-SFB
(Form-VI)-201701201) from M/s. Nantong
Chanyoo Pharmatech Co., Ltd, China is submitted.
Velpatasvir Copovidone: Copy of COA (Batch#
201703001) from M/s. Nantong Chanyoo
Pharmatech Co., Ltd, China is submitted.
2. Approval of API by regulatory authority of Sofosbuvir: Copy of GMP certificate issued by
country of origin or GMP certificate of API Jiangsu Nantong Pharmaceutical Association, China
manufacturer issued by regulatory authority has been submitted. It is valid until 07/09/2020.
of country of origin. Velpatasvir Copovidone: Copy of GMP certificate
issued by Nantong Chemical & Medical Industry
Association, China has been submitted. It is valid
until Dec. 05, 2019.
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir: The firm has submitted copy of
commercial invoice for the import of 880g of
Sofosbuvir (Form-VI) (Invoice#CY116386) attested
by ADC DRAP, Karachi dated 27-03-2017.
Velpatasvir Copovidone: The firm has submitted
copy of commercial invoice for the import of 440g
Velpatasvir Copovidone (Invoice#CY116386)
attested by ADC DRAP, Karachi dated 27-03-2017.
Rules, 1978.
● The firm has submitted 26 weeks Accelerated and 26 weeks Real Time Stability Data for 03 Batches.
278th Meeting:
instant dosage form conducted during last two product “Hepgard Tablets 400mg (sofosbuvir)”, which
years. was conducted on 9th August, 2017 and was presented
in 273rd meeting of Registration board. Registration
Board decided to approve registration of Hepgard
Tablets 400mg (sofosbuvir) by M/s. M/s Barrett
Hodgsons Pakistan (Private) Ltd. Karachi.
 According to the report generated on 18th April,
2017 following points were confirmed
a) The firm has used two separate HPLCs one for
testing for API while the other for testing of their
finished drug. The first HPLC software is not
21CFR compliant, whereas the second HPLC
software is 21CFR compliant.
b) Audit trail on the testing reports cannot be made as
the HPLC used is not 21CFR compliant, however,
the HPLC used for testing of stability batches of
the finished product is 21CFR compliant hence
audit trail on this HPLC can be made.
c) The firm possesses stability chambers with
continuous power supply and digital data loggers.
 While on Re-inspection for verification of
Authenticity of stability data dated 09th August,
2017 following points were confirmed
d) Redesigning of HVAC in the tablet manufacturing
area has been done.
Staff is adequately trained and training record is
available.
2. Documents for the procurement of API with Sofosbuvir: The firm has submitted copy of
approval from DRAP (in case of import). commercial invoice for the import of 0.88Kg & 750mg
of Sofosbuvir (Form-VI) (Invoice#CY116386) attested
Velpatasvir Copovidone: The firm has submitted
copy of commercial invoice for the import of 0.44Kg
Velpatasvir Copovidone (Invoice#CY116386) attested
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 Sofosbuvir: Copy of GMP certificate issued by

API manufacturer issued by regulatory Jiangsu Nantong Pharmaceutical Association, China
authority of country of origin. has been submitted. It is valid until 07/09/2020.
Velpatasvir Copovidone: Copy of GMP certificate
issued by Nantong Chemical & Medical Industry
Association, China has been submitted. It is valid until
Dec. 05, 2019.
qualification.
6. Certificate of analysis of the API, reference  Sofosbuvir: Copy of COA (Batch# RD-SFB
standards and impurity standards (Form-VI)-201701201) from M/s. Nantong
Chanyoo Pharmatech Co., Ltd, China is submitted.
 Velpatasvir Copovidone: Copy of COA (Batch#
201703001) from M/s. Nantong Chanyoo
Pharmatech Co., Ltd, China is submitted.
 Copies of COAs of working standards have been
submitted
Production Data
development & stability testing of trial for the Development of Hepgard-V Tablet 400mg
batches. +100mg”.
EXP-T-917 400 tablets 26-02-2018
PLT-T-075 800 tablets 28-04-2018
PLT-T-076 800 tablets 28-04-2018
11. Record of remaining quantities of stability 28 Tablets / pack
batches. Trial No Total no. Tablets Remaining
of used for Quantities
For
stability
testing
EXP-T-917 12 Packs 9 Packs 3 Packs
PLT-T-075 20 Packs 18 packs 2 Packs
PLT-T-076 20 Packs 18 packs 2 Packs
QA / QC DATA
28-11-2018.
with COAs for Sofosbuvir Form-VI and Velpatasvir
Co-povidone.
etc.)
Data of 03 Batches for Sofosbuvir Form-VI and
Velpatasvir Co-povidone from M/s Nantong Chanyoo
Pharmatech Co., Ltd, China.
17. Drug-excipients compatibility studies. The firm has submitted details of Drug-excipient
compatibility studies by designing combinations of
APIs and excipients.
6.8 buffers with MyHepAll Tablets 400mg/100mg
manufactured by M/s. Mylan, India with Batch #
3081910. The firm‘s product results are comparable
with MyHepAll 400/100mg Tablet.
19. Compliance Record of HPLC software 21CFR The firm has submitted audit trail reports of Hepgard-
& audit trail reports on product testing. V tablet for the testing time points.
The firm was communicated to provide clarification about testing frequency of accelerated stability study
data which is not as per 278th meeting of Registration Board. In response, the firm requested to accept the
submitted stability studies data for aforementioned product and for future they informed that we will follow
the test frequency as per decision made in 278th meeting.
Decision:
Finished Product
Specification
1250. M/s Wilson’s Excel Tablets 40mg Form 5-D Edarbi Tablet of
Pharmaceuticals Takeda Pharma
, I-9, Industrial Each uncoated tablet Dairy No. Nil dated (USFDA
Area, Islamabad contains: 18-03-2011, approved)
Azilsartan Rs.15,000/-,
Medoxomil (as 18-03-2011, N/A
Potassium)………… 35,000/-
…...40mg 29-10-2018, Last GMP
inspection
Anti-hypertensive 10’s, 20’s, 30’s & conducted on
60’s: 28.0 / Tablet 24-01-2018
Manufacturer’s concluding good
specifications
level of cGMP
compliance at
the time of
inspection.

Drug Excel Tablets 40mg
Name of Manufacturer M/s Wilson’s Pharmaceuticals, I-9, Industrial Area, Islamabad
Manufacturer of API M/s Ami Lifesciences Pvt. Ltd, Gujarat , India
Description of Pack Alu Alu Blister pack
Real Time: 30°C ± 2°C/65%±5% RH
Time Period Accelerated: 0,1,2,3,4,6 months
Real Time: 0, 3, 6 months
Frequency Accelerated: 06 (months)
Batch No. Trial # 01 Trial # 02 Trial # 03
Date of Initiation December, 2017 December, 2017 December, 2017
No. of Batches 03
No.
1. COA of API. Copy of COA (Batch# AZP/50310517) from M/s
Ami Lifesciences Pvt. 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 Control Administration, Gujarat State, India has
manufacturer issued by regulatory authority been submitted. It is valid until 26-04-2019.

sheets etc.
for the import of 960.30g of Azilsartan Medoxomil
potassium salt (Invoice#EXP/A/138/2017-18)
attested by ADC DRAP, Islamabad dated 16-08-
2017.
Rules, 1978.
278th Meeting:
Date of submission: 39582 vide diary no. 03-12-2018
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection reports of their
instant dosage form conducted during last two product “Saferon tablets (Sofosbuvir 400 mg)”, which
years. was presented in 278th meeting of Registration Board
held on 29-31st Jan, 2018.
Observations: Software of HPLC present in the firm
is 21 CFR compliant and audit trail on the testing
reports was available and confirmed. Panel reviewed
chromatograms for testing of API and trial batches at
0, 3 and 6 months for real time and accelerated
stability testing.
Decision: Registration Board decided to approve
registration of “Saferon (Sofosbuvir 400mg)” by M/s
Wilson Pharmaceuticals, Islamabad. Manufacturer will
place first three production batches on long term
stability studies throughout proposed shelf life and on
accelerated studies for six months.
approval from DRAP (in case of import). the import of 960.30g of Azilsartan Medoxomil
potassium salt (Invoice#EXP/A/138/2017-18) attested
by ADC DRAP, Islamabad dated 16-08-2017.
standard and impurity standards. the procurement of working standards and impurity
standards.
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate issued by Food and Drugs
API manufacturer issued by regulatory Control Administration, Gujarat State, India has been
authority of country of origin. submitted. It is valid until 26-04-2019.
qualification.
6. Certificate of analysis of the API, reference  Copy of COA (Batch# AZP/50310517) from M/s
standards and impurity standards Ami Lifesciences Pvt. Ltd, Gujarat, India is
submitted.
 Copy of COA of working standards have been
submitted
Impurity A
Impurity B
Impurity C
Production Data
development & stability testing of trial for the Development of “Excel Tablets 40mg”.
batches.
Trial # 01 1500 Tablets 12-2017
Trial # 02 1500 Tablets 12-2017
Trial # 03 1500 Tablets 12-2017
For
stability
testing
Trial # 01 570 Tabs
(3×10’s, 256 314
19 Packs)
Trial # 02 570 Tabs
(3×10’s, 256 314
19 Packs)
Trial # 03 570 Tabs
(3×10’s, 256 314
19 Packs)
QA / QC DATA
01-06-2018.
with COAs for Azilsartan Medoxomil Potassium Salt.
record of testing of stability batches (i.e. Testing Procedure for “Excel Tablets 40mg” along
etc.)
manufacturer. Accelerated (5oC±3oC) and 24 Months Real Time
25oC±2oC/60%±5%RH Stability Study Data of 03
Batches for Azilsartan Medoxomil potassium salt from
M/s Ami Lifesciences Pvt. Ltd, Gujarat, India.
17. Drug-excipients compatibility studies. The firm has submitted that ingredients of Excel
Tablets 40mg and Edarbi Tablets (innovator brand) are
same.
6.8 and pH 7.8 buffers with Edarbi Tablets 40mg
manufactured by M/s. Takeda, Osaka, Japan with
Batch # EB-TL40-04. The firm’s product (Excel
Tablets 40mg) results are comparable with Edarbi
Tablets 40mg.
19. Compliance Record of HPLC software 21CFR The firm has submitted audit trail reports of Excel
& audit trail reports on product testing. tablet 40mg from 14-12-2017 to 21-06-2018.
Decision:
Finished Product
Specification
1251. M/s Shaigan Tikanox-60 Tablets Form 5-D Brilinta Tablet of
Pharmaceuticals Astrazeneca
, 14-Km, Adyala Each Film coated Dairy No.1984 Pharms
Road, Post tablet contains: dated 25-05-2016, (USFDA
Office Dahgal, Ticagrelor…...60mg Rs.50,000/-, approved)
Rawalpindi 24-05-2016,
Platelet activation Not mentioned N/A
inhibitor
Last GMP
Manufacturer’s inspection was
specifications conducted on
14-12-2017 The
company is
found complying
CGMP as of
today and panel
unanimously
agreed to issue
CGMP
certificate for
export along
with COPP, The
management
was advised to
continue the
process of up
gradation.
Drug Tikanox-60 Tablets
Name of Manufacturer M/s Shaigan Pharmaceuticals, 14-Km, Adyala Road, Post Office Dahgal,
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
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
Batch No. T-001 T-002 T-003
No. of Batches 03
No.
1. COA of API. Copy of COA (Batch# 82160137) from M/s
Glenmark Pharmaceuticals Ltd. Gujarat, India is
submitted.
country of origin or GMP certificate of API Administration, Maharashtra State, India
manufacturer issued by regulatory authority (Certificate No 6081505) has been submitted. It is
of country of origin. valid until 03-05-2019.

sheets etc.
for the import of 600g of Ticagrelor
(Invoice#2007000394) attested by ADC DRAP,
Islamabad dated 08-09-2016.
Rules, 1978.
278th Meeting:
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 accelerated studies for six months.
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.
approval from DRAP (in case of import). the import of 600g of Ticagrelor
API manufacturer issued by regulatory Administration, Maharashtra State, India (Certificate
authority of country of origin. No 6081505) has been submitted. It is valid until 03-
05-2019.
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.
submitted
Impurity A
Impurity B
Impurity C
Production Data
development & stability testing of trial for the Development of “Excel Tablets 40mg”.
batches.
T-001 1000 Tablets 07-2017
T-002 1000 Tablets 07-2017
T-003 1000 Tablets 07-2017
For
stability
testing
T-001 866 232
T-002 881 634 247
T-003 871 237
QA / QC DATA
06-02-2018.
with COA for Ticagrelor.
record of testing of stability batches (i.e. Testing Procedure for “Tikanox-60 Tablets” along
etc.)
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
17. Drug-excipients compatibility studies. The firm has submitted that ingredients of Tikanox-60
Tablets and Brilinta 60mg Tablet (innovator brand) are
same.
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-
& audit trail reports on product testing. 60 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.
Decision:
Finished Product
Specification
1252. M/s Shaigan Tikanox-90 Tablets Form 5-D Brilinta Tablet of
Pharmaceuticals, Astrazeneca
14-Km, Adyala Each Film coated Dairy No.1985 Pharms
Road, Post Office tablet contains: dated 25-05-2016, (USFDA
Dahgal, Ticagrelor…...90mg Rs.50,000/-, approved)
Rawalpindi 24-05-2016,
Platelet activation Not mentioned N/A
inhibitor
Last GMP
Manufacturer’s inspection was
specifications conducted on
14-12-2017 The
company is
found complying
CGMP as of
today and panel
unanimously
agreed to issue
CGMP
certificate for
export along
with COPP, The
management
was advised to
continue the
process of up
gradation.
Drug Tikanox-90 Tablets
Name of Manufacturer M/s Shaigan Pharmaceuticals, 14-Km, Adyala Road, Post Office Dahgal,
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
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
Batch No. T-001 T-002 T-003
No. of Batches 03
No.
1. COA of API. Copy of COA (Batch# 82160137) from M/s
Glenmark Pharmaceuticals Ltd. Gujarat, India is
submitted.
country of origin or GMP certificate of API Administration, Maharashtra State, India
manufacturer issued by regulatory authority (Certificate No 6081505) has been submitted. It is
of country of origin. valid until 03-05-2019.

sheets etc.
for the import of 600g of Ticagrelor
Rules, 1978.
278th Meeting:
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 accelerated studies for six months.
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.
approval from DRAP (in case of import). the import of 600g of Ticagrelor
API manufacturer issued by regulatory Administration, Maharashtra State, India (Certificate
authority of country of origin. No 6081505) has been submitted. It is valid until 03-
05-2019.
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.
submitted
Impurity A
Impurity B
Impurity C
Production Data
development & stability testing of trial for the Development of “Tikanox-90 Tablets”.
batches.
T-001 1000 Tablets 07-2017
T-002 1000 Tablets 07-2017
T-003 1000 Tablets 07-2017
For
stability
testing
T-001 874 240
T-002 878 634 244
T-003 870 236
QA / QC DATA
06-02-2018.
with COA for Ticagrelor.
record of testing of stability batches (i.e. Testing Procedure for “Tikanox-90 Tablets” along
etc.)
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
17. Drug-excipients compatibility studies. The firm has submitted that ingredients of Tikanox-90
Tablets and Brilinta 90mg Tablet (innovator brand) are
same.
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-
& audit trail reports on product testing. 60 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.
Decision:
No of Manufacturer / (Proprietary Name Initial Diary & Availability / Decision /
Applicant + Dosage Form + Date, Fee Local Remarks
1253. M/s Dyson ROFIN TABLETS Form-5D DALIRESP
Research 500 mcg Diary No.1259 Tablet of
Laboratories (Pvt.) dated 27-10-2015, Astrazeneca
Ltd. 28th KM Each film coated Rs. 50,000/- dated (USFDA
Ferozpur Road, tablet contains: 15-10-2015 approved)
Lahore. Roflumilast…………
…..500mcg
Last inspection
Phosphodiesterase 4 report 01-08-
inhibitor 2017 with
conclusion that
Manufacturer’s panel
specifications Recommended
issuance of
GMP certificate
to the firm.
Drug ROFIN TABLETS 500 mcg
Name of Manufacturer M/s Dyson Research Laboratories (Pvt.) Ltd. 28th KM Ferozpur Road, Lahore.
Manufacturer of API M/s Glenmark Pharmaceuticals Ltd., Maharashtra, India
Description of Pack Alu/Alu Blister in outer unit carton
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0,1,2,3,6 (Months)
Real Time: 0,1,2,3,6,9 (Months)
Batch Size 1000 Tabs 1000 Tabs 1000 Tabs
No. of Batches 3
1. COA of API Copy of COA from M/s Glenmark Pharmaceuticals Ltd
India has been submitted
2. Approval of API by regulatory authority of The firm has submitted copy of GMP certificate of M/s
country of origin or GMP certificate of API Glenmark Pharmaceuticals Ltd, India (Certificate
manufacturer issued by regulatory authority No.6081505) issued by Food and Drug
of country of origin. Administration, Maharashtra State India.
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Lahore) attested commercial Invoice
Dated 25-10-2016 issued by M/s Glenmark
Pharmaceuticals (Pvt.) Ltd, India (invoice No:
2007500913) is submitted.
Rules, 1978.
● The firm has provided 06 Months Accelerated and 09 Months Real Time Stability Data for 03 Batches.
278th Meeting:
Date of submission: 29-10-2018 (Dy. No. 35703)
1. Reference of last onsite panel inspection for  Registration Board decided to approve registration
instant dosage form conducted during last two of “Sovir 400mg tablets (Sofosbuvir) by M/s. Dyson
years. Research Laboratories Pvt, 28-km, Ferozepur Road,
Lahore.” Manufacturer will place first three
production batches on long term stability studies
throughout proposed shelf life and on accelerated
studies for six months.
 Date of inspection: 17th January, 2018
 The HPLC software of the firm is 21 CFR
compliant.
 Firm has demonstrated audit trail reports (assay
analysis on HPLC) for the submitted stability
batches.
2. Documents for the procurement of API with Copy of ADC (Lahore) attested commercial Invoice
approval from DRAP (in case of import). Dated 25-10-2016 issued by M/s Glenmark
Pharmaceuticals (Pvt.) Ltd, India (invoice No:
2007500913) is submitted.
3. Documents for the procurement of reference The firm has submitted that required Reference
standard and impurity standards. standard for the product applied for Registration
‘Rofin 500mcg’ (Roflumilast 500mcg), was delivered
by indentor “Morgan Chemicals” in person at our
plant.
The firm undertakes that M/s Glenmark
pharmaceutical claims no impurity in their COA, so
physical unavalabilityof impurity is justified.
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP certificate of
API manufacturer issued by regulatory M/s Glenmark Pharmaceuticals Ltd, India (Certificate
authority of country of origin. No.6081505) issued by Food and Drug
Administration, Maharashtra State India.
5. Mechanism for Vendor pre-qualification The firm has submitted document stating rationale for
selection of Manufacturer of the API ‘Roflumilast’.
6. Certificate of analysis of the API, reference  Copy of COA of API (Roflumilast) from M/s
standards and impurity standards Glenmark Pharmaceuticals Ltd India has been
submitted.
 COAs of reference standards bearing Batch No.
83170223 from M/s Glenmark Pharmaceuticals Ltd
India has been submitted.
formulation of applied product.
Production Data
development & stability testing of trial for the Development of Rofin 500mcg Tablets”.
batches.
T02 1000 tablets 09-2017
T03 1000 tablets 09-2017
T04 1000 tablets 09-2017
batches. Trial No Tablets Tablets Remaining
for used for Quantities
Blistering stability of tablets
testing
T02 590 Tabs 460 Tabs 130 Tabs
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger record
and humidity monitoring of stability chambers for Accelerated stability chamber starting from 18-09-
(real time and accelerated) 2017 to 17-07-2018 and real time stability chamber
from 19-07-2017 to 01-12-2018.
along with COA for API Roflumilast.
record of testing of stability batches (i.e. Testing Procedures for Rofin Tablet 500mcg along
etc.)
15. Reports of stability studies of API from The firm has submitted accelerated stability study data
manufacturer. (40oC ± 2oC/ 75% ± 5% RH) of 6 months and real
time stability data (25oC ± 2oC/ 75% ± 5% RH) of 60
months for three batches of Roflumilast.
16. Analysis reports for excipients used. The firm has submitted analysis reports of excipients
used in formulation.
17. Drug-excipients compatibility studies. The firm has submitted that as the formulation of
Tablet Rofin 500mcg is qualitatively same to that of
innovator brand “Daliresp 500mcg” that provides
reason to exclude any drug-excipients incompatibility
but the quality is further ensured by the literature
review.
18. Record of comparative dissolution data.The firm has performed comparative dissolution
studies at pH 1.2, pH 4.5 and pH 6.8 with Daliresp
500mcg Tablets manufactured by M/s. Astrazeneca
pharms. The firm’s product (Rofin 500mcg Tablets)
results are comparable with Daliresp 500mcg Tablets.
19. Compliance Record of HPLC software Audit trails on testing reports of 1st month, 2nd month,
21CFR & audit trail reports on product 3rd month and 6th month were submitted by the firm.
testing.
Firm has not performed comparative dissolution profile at three dissolution media i.e., pH 1.2, pH 4.5, pH
6.8. Clarification is required.
Previous Decision: Deferred for submission of comparative dissolution profile at three dissolution media i.e.,
pH 1.2, pH 4.5, pH 6.8 (M-287).
Evaluation by PEC: The firm has submitted comparative dissolution profile at pH 1.2, pH 4.5 and pH 6.8.
Case No. 09: Miscellaneous cases
a. Cases Referred by Appellate Board:
1254. Sovel 400/100mg Tablet (Sofosbuvir/Velpatasvir) of M/s Indus Pharmaceuticals,
Karachi
The following case was forwarded by Deputy Director (Appellate Board) through letter No. F.1-
3/2018-AB(M-151) dated 4th February 2019 containing decision of the Appellate Board which
was taken in its 151st meeting held on 16-01-2019 as per Appeal No. 07/2018 of M/s Indus
Pharmaceuticals, Karachi for their product “Sovel 400/100mg Tablet” which was rejected by
Registration Board in 277th meeting. The letter further provided the decision which is as:
“The Board agreed with the submission made by the firm and allowed the appeal. The
Secretary, Registration Board is directed to place the product “Sovel 400/100mg Tablet
(Sofosbuvir/Velpatasvir) on the agenda of the forthcoming meeting of Registartion Board for
issuance of the registration of product accordingly”
Accordingly the agenda of the same product (as already rejected in 277th meeting) is placed
before the Board for its consideration.
Sr. Name & Address Brand Name Type of International Previous DRB
No. of Manufacturer / (Proprietary Name Form, Availability / Decision /
Applicant + Dosage Form + Initial Diary Local Remarks
Strength), & Date, Fee Availability (if any)
Composition, (including
Pharmacological differential GMP
Group, fee), Inspection
Finished Product Demanded Report Date
Specification Price / Pack & Remarks
size
1255. M/s Indus Pharma SOVEL Tablet Form 5-D EPCLUSA The Firm has
(Pvt.) Ltd. 400mg / 100mg Dairy No. by M/s claimed
1426 dated Gilead Manufacturer’s
26-27 & 63-67, Each film coated 05-10-2016 Sciences Inc. Specifications.
Sector 27, Korangi tablet contains:- USA.
Industrial Area Sofosbuvir…400mg Rs.50,000/-
74900. Velpatasvir…100mg Rs. 5,855/- per Not
pack of 28 applicable.
Karachi. (Anti-Viral) tablets.
Rs. 209.12/- GMP
per tablet. compliant
dated 16-08-
2017.
Drug SOVEL Tablet 400mg / 100mg (Sofosbuvir + Velpatasvir)
Name of Manufacturer M/s Indus Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API Sofosbuvir:
M/s Beijing Huikang Boyuan Chemical Tech Co., Ltd. China.
Velpatasvir:
M/s Xian Reyphon Pharmaceutical Co., Ltd. China.
API Lot No. Sofosbuvir: 151218
Velpatasvir: 161202
Description of Pack HDPE Plastic Bottle.
Real Time: 30°C ± 2°C & 65±5%RH
Frequency Accelerated: 0,1,3,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. P-1/SVL- P-2/SVL- P-3/SVL-400/100mg
400/100mg 400/100mg
Batch Size 2,500 Tablets 2,500 Tablets 2,500 Tablets
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority M/s Beijing Huikang Boyuan Chemical Tech Co.,
of country of origin or GMP certificate of Ltd. China:
API manufacturer issued by regulatory Copy of GMP Certificate for Pharmaceutical
authority of country of origin. Products issued by Liaoning Food and Drug
Administration, China is submitted.
M/s Xi’an Reyphon Pharmaceutical Co., Ltd. China:
Copy of GMP Certificate for Pharmaceutical
Products issued by Xi’an Food and Drug
Administration, China is submitted.
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir:
Copy of ADC (Karachi) attested invoice is
submitted.
Velpatasvir:
Copy of ADC (Karachi) attested invoice is
submitted.
7. Commitment to continue real time Yes
stability study till assigned shelf life of
the product.
8. Commitment to follow Drug Yes
Specification Rules, 1978.
PREVIOUS REMARKS OF EVALUATOR1
 The firm has clarified that at the time of application a tentative test method was submitted
specifying the dissolution 75% in 45min, but during formulation development, lab scale and pilot
scale batches were manufactured and the dissolution specifications now meet the USP criteria i.e.
75% in 30min and complies FDA’s proposed specifications for this formulation and has submitted
revised test methods and specifications.
 The firm also clarified that at the time of initial submission of dossier, a tentative formulation with
powdered form of Velpatasvir was submitted in Master Formulation as well as in Method of
Manufacturing, but during formulation development, lab scale and pilot scale batches were
manufactured with Velpatasvir Co-Povidone (1:1 dried dispersion form) and the same material will
be used in commercial manufacturing. A copy of COA of Velpatasvir Co-Povidone (1:1 dried
dispersion form) from M/s Reyphon China, along with revised Master Formulation and Method of
Manufacturing has been submitted.
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Pilot
Scale Batches.
During the proceedings of the Registration Board a case of personal hearing of M/s AGP Limited,
Karachi was discussed. The firms’ representative apprised Registration Board that M/s Beijing Huikang
Boyuan Chemical Tech Co. Ltd. (Supplier) is not a licensed pharmaceutical unit rather it is an R&D
plant therefore they are unable to provide GMP certificate from concerned province / state drug
administration.
Decision: Registration Board deferred the case for the following:

 Clarification of above since the API (Sofosbuvir) is of the same source (M/s Beijing Huikang
Boyuan Chemical Tech Co. Ltd); while the firm has submitted GMP Certificate for
Pharmaceutical Products issued by Liaoning Food and Drug Administration, China.
 Moreover the firm was directed to submit Legalized GMP Certificate for Pharmaceutical
Products issued by Liaoning Food and Drug Administration, China.
Now the firm vide letters dated 20-11-2017 (Dy. No. 21537) and 19-12-2017 (Dy. No. 25206) has
submitted the following clarification:
1. Company Profile of M/s Beijing Huikang stating that the headquarters and R&D Centre are located
at Fengtai District of Beijing whereas the plant is based in Fluoride Industrial Park, Fuxin City,
Liaoning Province.
2. Acknowledgement receipt from FDA of the following Drug Master File Submission:
DMF Number Assigned:28919
Date of Submission: December 24, 2014
DMF Type: II
Subject (Title): SOFOSBUVIR as manufactured in Beijing, China.
Holder: Beijing Huikang Bouyuan Chemical Co., Ltd.
Submitted By: Beijing Huikang Bouyuan Chemical Co., Ltd.
Agent: None
The status of DMF is marked “A”.
“A” = Active. This means that the DMF was found acceptable for filing, administratively, and has
not been closed.
3. Drug Master File (Module 3, Applicant’s Part) for Sofosbuvir depicting following information:
Head Office: Beijing Huikang Bouyuan Chemical Co., Ltd. No.5 Haiying Road, Fengtai District,
Beijing-100070, China.
Manufacturing Site: Fuxin Long Rui Pharmaceutical Co., Ltd. Fluoride Industrial Park, Fuxin City,
Liaoning Province, China.
Note: Fuxin Long Rui Pharmaceutical Co., Ltd. and Beijing Huikang Bouyuan Chemical Co., Ltd.
belongs to same owner.
Batch Analyses: COAs of 03 consecutive batches illustrating the actual results that have been
obtained from routine quality control by Beijing Huikang Bouyuan Chemical Co., Ltd. Add: No.7
Haiying Road, Science City, Fengtai District, Beijing, China.
4. Legalized photocopy of GMP Certificate for Pharmaceutical Products of M/s Fuxin Long Rui
Pharmaceutical Co., Ltd. issued by Fuxin Food and Drug Administration, China.
Proceedings: Mr. Mirza Danish Hussain Barlas (Manager Regulatory Affaiirs) appeared before the
Board to present the case. Mr. Danish agreed to the statement of M/s AGP Limited, Karachi (as
discussed in previous meeting) that M/s Bejing Huikang Boyuan Chemical Co., Ltd is an R&D unit and
apprised the Board that since in 2014, China forbid any sort of manufacturing in Capital City (Beijing)
therefore their principal manufacturer i.e. M/s Bejing Huikang Boyuan Chemical Co., Ltd, shifted their
commercial manufacturing facility to Liaoning Province under the name of M/s Fuxin Long Rui
Mr. Danish hence requested the Board to consider the GMP certificate of M/s Fuxin Long Rui
Pharmaceutical Co., Ltd. since their imported API i.e Sofosbuvir was manufactured by M/s Fuxin Long
Rui Pharmaceutical Co., Ltd.
Upon inquiring Mr. Danish could not submit any legal document, issued by relevant authority
confirming the relationship between M/s Bejing Huikang Boyuan Chemical Co., Ltd & M/s Fuxin Long
Rui Pharmaceutical Co., Ltd.
Decision of 277th meeting of Registration Board: Registration Board upon consideration of submission
made by representative of firm decided to reject the case since the firm could not satisfy the Board
regarding GMP status of their supplier of Sofosbuvir i.e. M/s Bejing Huikang Boyuan Chemical Co.,
Ltd.
1256. Omera (Omeprazole) & Esomega (Esomeprazole) Injections by M/s BF Biosciences

Ltd., 5-Km, Sundar Raiwind Road, Raiwind.
Following cases were presented in 277th 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:
1. 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
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
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.
2. 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
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
ii. Specification
3.2.S.4 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 &
3.2.S.7
reports have been submitted)
3.2.P DRUG PRODUCT
Description and Detail submitted for Composition of Drug
3.2.P.1 Composition of Drug Product
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
3.2.P.3 and 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)
ii. Analytical Procedures
3.2.P.5
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/cell 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 2 and 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:-
“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 264 th
meeting held on 09-07-2018 whereby the Central Licensing Board in its 264th 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 and 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.
Submitted for consideration of Board.
b. New submission of the firm against already rejected product:
M/s Vision Pharmaceuticals Islamabad has applied for transfer of their already registered product
Artilide Tablet 100mg (Reg No. 033768) from contract manufacturing to their own facility. The
case was considered and Rejected by Registration Board in its 252nd meeting due to non-
availability of the approval status of this formulation in reference regulatory authorities.
Registration Board in its 269th meeting decided to approve the formulation of nimesulide 100mg
Tablet after reviewing the formulation and keeping in view its approval by EMA.
The firm has submitted a fresh application dated 21-01-2019 with same brand name requesting to
consider their case on priority since their application was rejected earlier.
The details of the case are as follows:
1257. Name and address of M/s Vision Pharmaceuticals (Pvt.) Ltd., Plot No. 22 - 23,
manufacturer / Applicant Industrial Estate, Kahuta road, Model Town, Islamabad.
Brand Name +Dosage Form + Artilide 100mg Tablet
Strength
Nimesulide……100mg
Rs. 20,000/- Dated 21-01-2019
Type of Form Form 5
Approval status of product in Approved by EMA
Me-too status Nims tablet by M/s Sami
Decision:
c.
1. Name and address of Manufacturer / CCL Pharmaceuticals (Pvt.) Ltd. 62- Industrial Estate,
Applicant KotLakhpat Lahore.
Brand Name + Dosage Form + Strength Talam tablet 5/80mg
Amlodipine(as besylate)…..5 mg
Telmisartan…. 80mg
Type of Form Form-5
Finished Product Specification Innovator’s Specifications
Pack Size & Demanded Price 7×2’s, 1×10’s; As per SRO
Me-too status Ezitab-AM Tablet 5/80mg of M/s. Werrick
Pharmaceuticals
GMP status GMP inspection conducted on 20-04-2018 with
conclusive remarks that firm is operating at satisfactory
Remarks Of Evaluator
for the following:
For clarification of applied dosage form since reference
product is available as uncoated tablet whereas firm has
applied for film coated tablet.
Evaluation by PEC There is a typographical error in the Strength of one of
the APIs of above stated formulation, It was
erroneously written Amlodipine (as besylate )…5mg at
that time, but in real it is Amlodipine (as besylate
…10mg. so correction is required to be made in the
strength of Amlodipine(as besylate), & than composition
will become as Follow:
Each tablet contains:
Me too: Available
Approval status in RRA: Approved in US-FDA
Decision:
2. R-V vides its letter No. F.8-6/2013-Reg-V dated 24th October, 2018 forwarded a duplicate dossier of
below mentioned product of CCL Pharmaceutical for Evaluation having following information on
the letter.
Sr. Name of drug(s) with composition Date of submission of
N. Name of firm fee
1. M/s. CCL Pharma, Talam tablet 5/80mg Dy. No. 9695
Lahore. Each film coated tablet contains: Dated 21-07-2017
Amlodipine(as besylate)…..5 mg (Duplicate Dossier)
Name and address of Manufacturer / CCL Pharmaceuticals (Pvt.) Ltd. 62- Industrial Estate,
Applicant KotLakhpat Lahore.
Brand Name+DosageForm+Strength Talam tablet 5/80mg
(duplicate fee challan & duplicate dossier)
Type of Form Form-5
Finished Product Specification Innovator’s Specifications
Pack Size & Demanded Price 7×2’s, 1×10’s; As per SRO
Me-too status Ezitab-AM Tablet 5/80mg of M/s. Werrick
Pharmaceuticals
GMP status GMP inspection conducted on 20-04-2018 with
conclusive remarks that firm is operating at satisfactory
Remarks Of Evaluator
Decision:
Registration-I
Case No.1. Standardization of Label Claim of Sacubitril and Valsartan Containing

Tablets
Registration Board in its various meetings approved the grant of registration for
following products containing valsartan and sacubitril as per below mentioned details:
Sr. No. Reference of Name of Name of Drug and Composition Standardized Label Claim
Reg. Board Manufacturer as per USFDA
Meeting
I II III IV V
1. M-285 M/s Atco Valsac tablet 24mg/26mg Valsac tablet 24mg/26mg
Laboratories
Limited, B-18, Each film coated tablet contains: Each film coated tablet
S.I.T.E., Karachi. Sacubitril…24.3mg contains:
Valsartan…25.7mg Sacubitril…24mg
(as Sacubitril valsartan sodium Valsartan…25mg
salt complex)
Laboratories
Sacubitril…48.6mg contains:
S.I.T.E., Karachi.
salt complex)
Laboratories
Sacubitril…97.2mg contains:
S.I.T.E., Karachi.
salt complex)
4. M-283 M/s Sami Valsatril 97mg/103mg Tablet Valsatril 97mg/103mg
Pharmaceuticals Each film coated tablet contains: Tablet
(Pvt.) Ltd. F-95, Sacubitril …… 97.2 mg Each film coated tablet
Off. Hub River Valsartan ….…. 102.8 mg contains:
Road, S.I.T.E., Sacubitril …… 97mg
Karachi Valsartan ….…103 mg

Pharmaceuticals Each film coated tablet contains: Tablet
(Pvt.) Ltd. F-95, Sacubitril ……….48.6 mg Each film coated tablet
Off. Hub River Valsartan ….…….51.4 mg contains:
Road, S.I.T.E., Sacubitril ……….49 mg
Karachi Valsartan ….…….51 mg
Pharmaceuticals Each Tablet contains: Tablet
(Pvt.) Ltd. F-95, Sacubitril ………….. 24.3mg Each Tablet contains:
Off. Hub River Valsrtan ……………25.7mg Sacubitril ……….. 24mg
Road, S.I.T.E., Valsrtan ………….26mg
Karachi
Before issuance of registration letters for above mentioned formulations, the label claim
was standardized in accordance with that approved by USFDA as mentioned vide column V of
above table.
Submitted for information of the Registration Board.
Case No.2. Approved Products of M/s Noa Hemis, Karachi

Registration Board in its 284th meeting, held on 31st July- 1st August, 2018,
approved the grant of registration for following products of M/s Noa Hemis, Karachi as per
below mentioned details:
S.No. Brand Name & Composition GMP Status mentioned Decision taken vide M-
in minutes of M-284 284
1. Symenda 5mg Tablet Last GMP Inspection Approved

conducted on 20-03-2018
Each film coated tablet contains: and
Memantine Hydrochloride….5mg report concludes that firm
USP is considerd to be
operating at an acceptable
level of GMP compliance
2. Symenda 10mg Tablet Each film -do- Approved

coated tablet contains:
Memantine Hydrochloride….10mg
USP
3. Opamac 25mg Tablet Each film -do- Approved

Topiramate…….25mg
USP
4. Opamac 50mg Tablet Each film -do- Approved.

Topiramate……50mg
USP
5. Maxi-Luma Cream -do- Approved with
innovator’s
Each gram of cream contains:
specification.
Fluocinolone Acetonide
……….0.1mg
Hydroquinone….40mg
Tretinoin……….0.5mg
Manufacturer’s specification
6. Osmolat Rice Powder Sachet -do- Approved with

(Banana flavour) innovator’s
specification.
Rice Powder (Pre cooked)…….6g
Sodium Citrate……0.58
Sodium Chloride…..0.35g
Potassium Chloride..0.30g
Manufacturer’s specification
7. Osmolat Rice Powder Sachet -do- Approved with

(Orange flavour) innovator’s
specification.
Rice Powder (Pre cooked)…….6g
Sodium Citrate……0.58
Sodium Chloride…..0.35g
Potassium Chloride..0.30g Mfg.

Specification
However, in the same meeting following 05 cases of M/s Noa Hemis, Karachi were deferred for
updated status of GMP of the firm form QA & LT division as inspection report submitted by firm (dated
20-3-2018) does not conclude GMP compliant status. Details are as under:
S# Brand Name & Composition GMP Status Decision taken vide M-284
mentioned in
minutes of M-284
1. Rinip Tablet 1mg The FID conducted Deferred for updated status of GMP of
inspection of the the firm form QA & LT division as
Each film coated tablet firm on 20-3-2018 inspection report submitted by firm does
contains: and noticed some not conclude GMP compliant status.
Ropinirole (as HCl)…..1mg observations.
Accordingly, letter
USP was sent to the firm
to rectify the
observations. Firm
did not submit
compliance report.
2. Rinip Tablet 0.25mg -do- Deferred for updated status of GMP of

the firm form QA & LT division as
Each film coated tablet
inspection report submitted by firm does
contains:
not conclude GMP compliant status.
Ropinirole (as HCl)…..0.25mg
USP
3. Tusofyl Syrup -do- Deferred for following:
Each 5ml syrup contains:  Updated status of GMP of the firm

form QA & LT division as
Acefylline inspection report submitted by firm
Piperazine…..125mg does not conclude GMP compliant
status.
Manufacturer’s  Evidence of approval of applied
authorities/ agencies which were
adopted by the Registration Board
4. Tusofyl Cough Syrup -do- Deferred for following:
Each 5ml syrup contains:  Updated status of GMP of the firm

form QA & LT division as
Acefylline Piperazine…..45mg inspection report submitted by firm
does not conclude GMP compliant
Diphenhydramine as status.
HCl……8mg  Evidence of approval of applied
Manufacturer’s authorities/ agencies which were
adopted by the Registration Board
5. Robotin Syrup -do- Deferred for updated status of GMP of
the firm form QA & LT division as
Each 5ml syrup contains: inspection report submitted by firm does
Carbocysteine……250mg not conclude GMP compliant status.
Manufacturer’s
Accordingly, registration letters of products approved in 284th meeting were with held for
clarification regarding GMP status. Later on, in 285th meeting of Registration Board, the firm was again
granted registration of following products considering same inspection report i.e., dated 20-03-2018, as
per below mentioned details:
S.No. Brand Name & Composition GMP Status mentioned Decision taken vide M-
in minutes of M-284 284
1. DIFLUCORT CREAM Last GMP Inspection Approved with

Each gram cream contains: conducted on 20-03-2018 innovator’s
Diflucortolone valerate…………..1mg and report concludes that specification.
Isoconazole nitrate………...10mg firm is considered to be
In-house operating at an acceptable
2. ZiQuil Syrup Last GMP Inspection Approved with

Each 5ml of syrup contains: conducted on 20-03-2018 innovator’s
Paracetamol…….250mg and report concludes that specification.
Promethazine HCl…..5mg firm is considered to be
Dextromethorphan HBr…….3.75mg operating at an acceptable
In-house specification level of GMP compliance.
The firm has now provided subsequent inspection report dated 09-08-2018, indicating “Good
compliance” and requested for issuance of registration letter for products approved in M-284.
Submitted for consideration of the Registration Board.
Case No.3 Request For Change In Registration Status of Products (s) From M/s. AGP
(Private) Limited B-23, S.I.T.E, Karachi To M/s. GlaxoSmithKline Pakistan
Ltd, Karachi.
M/s. GlaxoSmithKline Pakistan Ltd, Plot#5, Sector 21, Korangi Industrial Area,
Karachi (DML#000248) has requested to change registration status of following product from
M/s. AGP (Private) Limited B-23, S.I.T.E, Karachi to their name of the firm:-
Sr. Reg. Name of Drug (s) Initial letter of registration with renewal status.
No. No.
1. 006952 Nootropil Injection Initial registration date 30-01-1984 in the name of M/s.
Each 5ml contains:- PDH Labs; Lahore
Piracetam… 1gm 1st transfer of reg. approval dated 31-12-1995
2nd transfer of reg. approval dated 27-02-2006
Renewal of application granted on 28-06-2011 for 5 years
Renewal applied on 22-01-2016
They have provided following documents:-
i. Application on From-5 along with fee of Rs. 20,000/-
ii. Copies of initial letter of registration and its renewal status.
iii. NOC for CRF.
i. Manufacturing facility of the applicant firm.
ii. Copy of GMP inspection report.
iii. NOC from existing registration holder dated 02-05-2017.
Decision of M-284:
Registration Board deferred the case for fresh NOC from registration holder and for renewal
status from RRR Section.
The firm has now submitted fresh NOC from M/s. AGP (Private) Limited B-23, S.I.T.E,
Karachi dated 26-12-2018. Furthermore, RRR section has communicated the renewal status as
“Renewal application of year 2016 by M/s AGP (Pvt) Ltd. Karachi received within time, under
Rule 27 of Drug Licensing, Registering & Advertising Rules, 1976.”
Case No.4 Approved Product of M/s Sante (Pvt) Limited, Karachi
Registration Board, in its 281st meeting, approved the grant of registration for following
product of M/s Sante (Pvt) Limited, Karachi
Name and address of manufacturer / M/s Sante (Pvt) limited Pharmaceuticals, 245/2-Z,
Applicant Block 6, PECHS, Karachi
Brand Name +Dosage Form + Strength Ilashes Ophthalmic Solution 0.03%
Diary No. Date of R& I & fee Dy.No. , 18-4-2016, Rs.50,000/- (Duplicate)
Bimatoprost…………0.3 mg
Pharmacological Group Prostaglandin Analog
Type of Form Form-5
Pack size & Demanded Price 1’s; As Per SRO
Approval status of product in Reference Bimatoprost of Apotex Inc (USFDA)
Me-too status Lumigan eye drops of Barret Hodgson (Reg #
033177)
good compliance to GMP
Previous remarks of the Evaluator. Section of sterile ophthalmic drops present.
Previous decision(s) Deferred in 277th meeting for confirmation of Diary
number date of submission of dossier from R & I
section.
Evaluation by PEC ● The firm has submitted Diary No. 10809 from R&I
● Photocopy of fee challan Rs. 50,000/- dated 20-05-
2014 has been provided.
Decision: Approved with innovator’s specifications. Reference will be sent to Budget &
Accounts Division for verification of challan and Board authorized its Chairman for the
issuance of registration letter.
Before issuance of registration letter, the firm was asked to provide alternate brand names. In
response, the firm has provided alternate names and informed that they initially applied for
above mentioned product on Form 5D with prescribed fee of Rs.50,000/-because their product,
having same formulation as of Lumigan Eye Drops of M/s Barrett Hodgson (R#033177),
however, with a new indication i.e., “to treat hypotrichosis of the eyelashes by increasing their
growth including length, thickness and darkness.” In this regard, the firm has also provided copy
of application on Form-5 along with detail of correspondence with Pharmaceutical Evaluation
Cell supporting their aforementioned claim.
It is submitted that the instant formulation containing Bimatprost (A prostaglandin analogue)

has been approved by USFDA for following indications:
i. Reduction of elevated intraocular pressure in patients with open angle glaucoma or

ocular hypertension (i.e., USFDA approved Lumigan by Allergan, supplied in sterile
opaque white low density polyethylene ophthalmic dispenser bottles and tips with
turquoise polystyrene caps in the following sizes:
 1mL fill in a 5 mL container
 2.5mL fill in a 5 mL container
 5mL fill in a 10 mL container
 7.5mL fill in a 10 mL container
ii. Treatment of hypotrichosis of the eyelashes by increasing their growth including
length, thickness and darkness (i.e., USFDA approved Latisse by Allergan), supplied
in sterile opaque white low density polyethylene dispenser bottles and tips with
turquoise polystyrene caps accompanied by sterile, disposable applicators:
 3 mL in a 5 mL bottle with 70 applicators
 5 mL in a 5 mL bottle with 140 applicators
WARNING AND PRECAUTIONS (AS PER USFDA)
Effects of Latisse on Intraocular Pressure
In patients using LUMIGAN or other prostaglandin analogs for the treatment of elevated
intraocular pressure, the concomitant use of LATISSE may interfere with the desired
reduction in intraocular pressure. Patients using prostaglandin analogs for intraocular
pressure reduction should only use LATISSE after consulting with their physician.
In this regard, it is also submitted that M/s Schazoo Pharmaceuticals, Lahore, has already
been granted approval for registration of same formulation with above mentioned 2 different
indications under different brand names vide 276th meeting of Registration Board.
Furthermore, as per copy of form-5, provided by the firm, they have applied pack size of 3ml
in a 5ml Bottle with applicators. However, the firm has now requested to issue registration letter
with following pack sizes:
 3ml with 70 applicators
 5ml with 140 applicators
Case No.5 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 243rd meeting, held on 08-09 May,
2014, as per following details:-
S Name & 1. Brand Name 1. Type of form 1. Me-too Decision

# Address of 2. Dosage Form 2. Type of Status
Manufactu 3. Composition application 2. GMP
4. Pharmacological 3. Demanded Price/ status
re/
Group Pack size
Applicant 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. Paracetamo Approved
GaxoSmith 2. 20’s Rs. 200/- l- Osteo with change
Kline Each modified release 3. 22-06-12 665mg in brand
tablet contains: 4. 18-04-13 modified
Pakistan name.
Rs.150,000/- release
Limited, Paracetamol Ph Eur tablets
35- 665mg modified approved
Dockyard release by TGA
Road, West 2. New Drug
Wharf, (Non narcotic 3. Firm was
Karachi Analgesic) inspected
on 20-01-
Finished product 2011 and
specifications are GMP
Manufacturer compliance
was good.
The Pricing Division has now fixed the price of above mentioned formulation. However,
while possessing for issuance of registration letter, it was informed by the firm 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
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.
Case No.6 Request for Change in Registration Status of Products From M/s Cirin
Pharmaceuticals, Hattar To M/s. ICI Pakistan Ltd. Karachi.
M/s. ICI Pakistan Ltd., S-33, Hawkes Bay Road, Karachi has requested for for
Change in Registration Status of following Products from M/s Cirin Pharmaceuticals (Pvt) Ltd,
32/2A, Phase III, Industrial Estate, Hattar 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 Misoclear Tablets 084191 28-04-2017 Dy.1737 (14.01.2019)
Each tablet contains:- Rs.100/10’s Rs.20,000/-
Misoprostol…….... 200mcg
( Int. Ph. Specification)
The management of the firm has provided following documents:-

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 ICI Pakistan Ltd., S-33, Hawkes Bay Road, Karachi for
renewal of DML as evidence of approved section (Tablet General) dated 02-03-2018.
iv. 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.
v. NOC from M/s Cirin Pharmaceuticals, 32/2A, Phase III, Industrial Estate, Hattar dated
11-01-2019.
Case No.7 Request of M/s. Delta Pharma Pvt Ltd, Nowshera For Grant of Afresh
Registration.
Registration Board in 276th meeting held on 22ND- 25TH November, 2017, declared
registration of all drugs of M/s. Delta Pharma Pvt Ltd, Nowshera invalid due to non renewal of
DML. The firm has now been granted approval of Oral Liquid (general) Section and Dry
Suspension (General) Section vide Licensing Division’s Letter No. F.3-2/96-Lic pt dated 03-12-
2018. 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# Brand Name, Dy.No./Date Evidence of Last Inspection Remarks
Composition and & Availability in Report & DML
(Reg.No) Demanded RRAs and Me-
Pack / Price too Status
Provided by Firm
1. M.B.Ron Syrup Dy.No.1174 N/A Last inspection -
Each 5ml contains: 06-12-18 report
Iron (III) Hydroxide 20,000/- Ironal Syrup by 12-10-2018 for
Polymaltose Complex 26-12-2018 M/s. Helix Pharma grant of
eq. to Elemental (Pvt) Ltd,. Karachi additional
Iron…..50mg 120ml sections.
(Reg.No.040607) As per SRO DML 18-12-
2017
2. Delmol Suspension Dy.No.1173 UK MHRA -do- USP
Each 5ml contains: 26-12-18 approved. Monograph
Paracetamol……120mg 20,000/- is available
(Reg.No.022294) 04-12-18 Paracetamol for applied
60ml Suspension by formulation
As per SRO M/s. British
Pharma, Lahore.
3. Delmol Forte Dy.No.1176 UK MHRA -do- USP
Suspension 26-12-18 approved. Monograph
Each 5ml contains: 20,000/- is available
Paracetamol……250mg 04-12-18 Panadol Forte for applied
(Reg.No.022295) 60ml Suspension by formulation
As per SRO M/s.
GlaxoSmithKline
Pakistan Limited
4. Deltafen Suspension Dy.No.1175 UK MHRA -do- USP
Each 5ml contains: 26-12-18 approved. Monograph is
Ibuprofen………100mg 20,000/- available for
(Reg.No.020915) 04-12-18 Ibudol Suspension applied
90ml by M/s. Mediways formulation.
As per SRO International
Lahore
Case No.8 Approved Product of M/s City Pharmaceuticals Laboratories, Karachi
Registration Board, in its 237th meeting held on 26th February, 2013, approved the
following product of M/s City Pharmaceuticals Laboratories, Karachi as per following
details:
S. Name of drug(s) & Proposed Demand Remarks
No. Composition Pack size ed Price
1 Vitamin B12 1000 mcg Injection As per PRC As per Deferred for provision
Each ml contains: PRC of information
Vitamin B12 ……....1000 mcg regarding calibration of
machines, validation of
processes &
appointment of
sufficient technical
staff
Decision of M-237: The request of the firm was acceded by the Board subject to submission
of differential fee.
Pricing Division has fixed the MRP of above mentioned formulation, vide SRO 906 dated
07-09-2017and the firm has now requested for issuance of registration letter and submitted
following documents:
i. Evidence of paid fee of Rs.12,000/-
ii. Last GMP Inspection Report Dated 26-09-2018(Satisfactory)
iii. Section Approval (Liquid Injection) dated 11-06-2011
Case No.9. Request For Change in Registration Status of Products From M/s OBS
Pakistan (Pvt.) Ltd, Karachi. To M/s. Aspin Pharma, Karachi.
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:
Registratio
Approved Dy.No, Date &
S.#. Reg.# Name of Drug(s) n
Pack/MRP Fees/Remarks
History
I II III IV V VI
1 093005 Gabolest Capsule 25mg Rs.121.00/ Initial date Dy.No.3393

14’s of
Each capsule contains: 08-02-2019
Reg.
Pregabalin .... 25mg 31-12-2018 Rs.70,000/-
(As per Innovator's Specifications)

14’s of
Reg.
Pregabalin ... 50mg Rs.70,000/-
31-12-2018

14’s of
Reg.
Pregabalin .... 100mg Rs.70,000/-
31-12-2018

14’s of
Reg.
31-12-2018

14’s of
Reg.
31-12-2018

14’s of
Reg.
Pregabalin ..... 150mg Rs.70,000/-
23-01-2015
7 076662 Gabolest Capsule 300mg Rs.1358.00 Initial date Dy.No.3386

/14’s of Reg.
23-01-2015
Pregabalin ..... 300mg Rs.70,000/-
Each capsule contains: 14’s of 08-02-2019
Pregabalin .... 75mg Reg. Rs.70,000/-
(As per Innovator's Specifications) 23-01-2015
9 089147 Kapdex 30mg Capsule Rs.451.00/ Initial date Dy.No.3383

30’s of
Reg.
Dexlansoprazole dual delayed Rs.70,000/-
release pellets eq. to 31-05-2018
Pellets registered
Dexlansoprazole … 30mg
source:
(As per Innovator’s Specification)
M/s Vision
Pharmaceuticals,
Islamabad
10 089148 Kapdex 60mg Capsule Rs.696.00/ Initial date Dy.No.3382

30’s of
Reg.
Dexlansoprazole dual delayed Rs.70,000/-
release pellets eq. to 31-05-2018
Dexlansoprazole … 60mg
Pellets registered
(As per Innovator’s Specification)
source:
M/s Vision
Pharmaceuticals,
Islamabad
11 075821 Virunix-B 1mg Tablet Rs. Initial date Dy.No.3384

17000.00/3 of
Each film coated tablet contains: 0’s 08-02-2019
Reg.
Entecavir as monohydrate ...1mg Rs.70,000/-
03-04-2013
(Manufacturer Specifications )
Renewal
Formulation is
18-01-2018 available in USP.
12 075822 Virunix-B 0.5mg Tablet Rs. Initial date Dy.No.3385

9000.00/30 of
Each film coated tablet contains: ’s 08-02-2019
Reg.
Entecavir as monohydrate...0.5mg Rs.70,000/-
(Manufacturer Specifications ) 03-04-2013
Renewal USP Monograph

is available for
18-01-2018 applied
formulation

i. Original Fee challan of Rs. 70,000/- for each product.
ii. Copies of initial letters of registration and renewal status as stated in column V above.
iii. Tablet (General) Section approval of M/s. OBS Pakistan (Pvt.) Ltd; Karachi verified from
Licensing Division’s letter for renewal of DML (dated 08th 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 28th January, 2019.
vi. Consent/NOC from M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 28th January, 2019 for
Contract manufacturing of above mentioned products.
vii. DML of M/s. OBS Pakistan (Pvt.) Ltd; Karachi dated 31st 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
Pakistan (Pvt.) Ltd, Karachi. To M/s. Aspin Pharma, Karachi.
M/s. Aspin Pharma (Pvt.) Ltd; Plot No. 10 & 25, Sector 20, Korangi Industrial
AGP Limited, D-109, S.I.T.E, Karachi (Contract Manufacturer remain the same). 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 057942 M-Span 100mg/5ml Dry Rs.180.00/30ml Initial date of Dy.No.3414

Suspension
Reg. 11-02-2019
Each 5ml contains:
30-07-2009 via Rs.20,000/-
Cefixime as trihydrate contract
….100mg Manufacturing
(USP Specifications) from M/s
Mediate
2 057943 M-Span 200mg/5ml Dry Rs.300.00/30ml Pharma Ltd Dy.No.3416
Suspension
11-02-2019
Each 5ml contains:
Change of Rs.20,000/-
Cefixime as trihydrate Contract
(USP Specifications) to M/s Macter
International
3 057944 M-Span 400mg Rs.325.00/5’s Dy.No.3415
Capsules 07-02-2011
11-02-2019
Rs.20,000/-
Cefixime as trihydrate Change of
….400mg Contract
Manufacturing
(USP Specifications) to M/s AGP
Ltd
14-12-2015
Permission is
valid up to 30-
06-2020
i. Original challan Fee of Rs. 20,000/- for each product.

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
Case No.11. Request For Change in Registration Status of Products From M/s AGP Ltd,
Karachi To M/s. Aspin Pharma, Karachi.
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:
Registratio
Approved
S.No. Reg.No. Name of Drug(s) n Remarks
Pack/MRP
History
I II III IV V VI
1 055121 Xovat 5mg Tablet Rs. Initial date Dy.No.3395

120.00/10’s of
Each tablet contains: 11-02-2019
Reg.
Rosuvastatin as calcium Rs.70,000/-
….5mg 02-03-2009
(Manufacturer Specifications) Last

Standard
Renewal
Formulation
02-03-2014 approved by RRAs
is film coated.

200.00/10’s of
Reg.
….10mg 02-03-2009

Standard
Renewal
Formulation
is film coated.

400.00/10’s of
Reg.
….20mg 02-03-2009

Standard
Renewal
Formulation
is film coated.

800.00/10’s of
Reg.
….20mg 26-09-2017
(As per Innovators

Standard
Specifications)
Formulation
approved by RRAs
is film coated.
ii. Copies of initial letters of registration as stated in column V above.
iii. Section (Tablet General) approval of M/s AGP from Licensing Division dated 28-04-
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.
Pakistan (Pvt.) Ltd, Karachi To M/s. Aspin Pharma, Karachi.
Global Pharmaceuticals Pvt. Ltd; Islamabad (Contract Manufacturer remain the same). The
details are given as under:
Pack/MRP History
I II III IV V VI
1 089308 Onem IV Injection Rs.776.55/1’s Initial date of Dy.No.3399
Each vial contains: Reg. 11-02-2019
Imipenem Monohydrate 29-12-2018 via Rs.20,000/-

eq. to Imipenem contract
from M/s
Cilastatin Sodium eq. to Global
Cilastatin …. 500mg Pharmaceutical
(USP Specifications) s Pvt. Ltd

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.
vi. DML of M/s Aspin dated 31st May, 2015.
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.
Case No.13. Request for Change in Registration Status of Products From M/s. Spencer &
Company, Karachi to M/s. Zafa Pharmaceutical Laboratories (Private) Ltd.,
Karachi.
M/s. Zafa Pharmaceutical Laboratories (Private) Ltd., Karachi (DML# 000516) has
requested for change of registration status of following products from M/s. Spencer & Company,
D-105, SITE, Karachi to their name through contract manufacturing by M/s Reign
Pharmaceuticals TBIC PCSIR (Pvt) Ltd., Karachi. The details are given as under:
Registratio
Approved
Pack/MRP
History
I II III IV V VI
1 067695 Moxilox 400mg Tablet Rs.475/5’s Initial date Dy.No.3419

of
Reg.
Moxifloxacin ……….400 mg Rs.50,000/-
16-04-2011
(BP Specification) Standard
Last Formulation
Renewal approved by
RRAs is film
06-04-2016 coated.
2 053035 Levos 500mg Tablets Rs.416.00/ Initial date Dy.No.3420

10’s of
Reg.
Levofloxacin (as Rs.50,000/-
hemihydrate)………..500mg 29-10-2008
Standard
(USP Specification) Last Formulation
approved by
Renewal RRAs is film
coated.
29-06-2015
3 036902 Levos 250mg Tablets Rs.250/1x10’ Initial date Dy.No.3421

s of
Each tablets contains: 11-02-2019
Reg.
Levofloxacin (as Rs.50,000/-
Hemihydrate)………..250mg 31-01-2005
Standard
Last Formulation
Renewal approved by
RRAs is film
23-01-2015 coated.
4 014283 Polygard Tablets As per Initial date Dy.No.05

SRO of
Each tablet contains:- 471(I)/93/1 12-02-2019
0’s Reg.
Ciprofloxacin HCl Rs.20,000/-
Monohydrate 250mg 05-08-1993
(equivalent to Ciprofloxacin Standard
Last Formulation
250mg base)
Renewal approved by
RRAs is film
26-07-2013 coated.
5 053036 Polygard 500mg Tablets Rs.260/10’ Initial date Dy.No.04

s of
Each tablet contains:- 12-02-2019
Reg.
Ciprofloxacin........500mg Rs.20,000/-
29-10-2008
(as Hydrochloride) Standard
Last Formulation
(USP Specification) Renewal approved by
RRAs is film
07-07-2015 coated.

iii. Section approval (Tablet) of M/s. Reign, Pharmaceuticals TBIC PCSIR (Pvt) Ltd.,
Karachi verified from panel inspection report dated 28-11-2013.
iv. Copy of last GMP inspection report of M/s. Reign, Karachi dated 08th November, 2017
indicating “Good” level.
v. NOC from M/s. Spencer & company (Pvt) Ltd, Karachi dated 04h February, 2019.
vi. Consent/NOC from M/s Reign, Karachi for contract manufacturing.
vii. Copy of Contract Agreement between M/s. Zafa, Karachi & M/s Reign, Karachi.
viii. DML of M/s. Reign, Karachi dated 28th November, 2012 with renewal applied on 26-
09-2017.
ix. Licensing Division’s Letter F.No.2-3/88-Lic (Vol-III) as evidence for validity of DML of
M/s Spencer & Company till 18-07-2015 with renewal applied on 22-07-2015.
x. DML of M/s. Zafa, Pharmaceutical Laboratories (Private) Ltd., Karachi (DML# 000516)
xi. Undertakings in the light of SOPs approved vide M-283.
Company, Karachi to M/s Reign Pharmaceuticals (Pvt) Ltd., Karachi
M/s Reign Pharmaceuticals (Pvt) Ltd., Karachi (DML# 000757) has requested for
change of registration status of following products from M/s. Spencer & Company, D-105, SITE,
Karachi (DML # 000272) to their name. The details are given as under:
Registratio
Approved
Pack/MRP
History
I II III IV V VI
1 032559 Avofen Tablets Rs.70.00/3x Initial date Dy.No.3413

10’s of
Reg.
Ketotifen (as Hydrogen Rs.20,000/-
fumarate)…………..1mg 17-04-2004
Last
UK MHRA
Renewal
approved.
14-04-2014
2 032560 Avofen Syrup Rs.45.00/60 Initial date Dy.No.3412

ml of
Each 5ml contains:- 11-02-2019
Reg.
Ketotifen (as Hydrogen Rs.20,000/-
fumarate)…………..1mg 17-04-2004
Last
Renewal ANSM approved.
14-04-2014
3 039382 Eron Plus Drops Rs.65.00/15 Initial date Dy.No.3407

ml of
Each ml contains:- 11-02-2019
Reg.
Iron Polymaltose Complex Rs.20,000/-
.50mg 12-07-2005
Last
Standard
Renewal
Formulation
29-06-2015 contains” Iron (III)
Hydroxide
Polymaltose
Complex eq. to
Elemental
Iron…50mg/ml”
4 039383 Eron Plus Syrup Rs.70.00/60 Initial date Dy.No.3408

ml of
Reg.
Iron Polymaltose Complex Rs.20,000/-
50mg 12-07-2005
Last
Standard
Renewal
Formulation
29-06-2015 contains” Iron (III)
Hydroxide
Polymaltose
Complex eq. to
Elemental
Iron…50mg/5ml”
and the firm has

applied the same.
5 039384 Eron Plus Tablets Rs.70.00/10 Initial date Dy.No.3409

’s of
Reg.
Iron Polymaltose Complex
100mg 29-10-2005 Rs.20,000/-
Folic Acid …………0.35mg Last Standard

Renewal Formulation
contains” Iron (III)
29-06-2015 Hydroxide
Polymaltose
Complex eq. to
Elemental
Iron…100mg”
and the firm has

applied the same.
6 053030 IRI Syrup Rs.109.00/1 Initial date Dy.No.3400

20ml of
Reg.
Lactulose ………...3.35gm Rs.20,000/-
29-10-2008
(USP Specification) Registered Source:
Last Import in bulk
Renewal from M/s. Inalco
S.P.A VIA
14-04-2014 Calabiana,
Milano, Italy and
With fee of local repacking
Rs 10,000/- at M/s. Spencer
Pharmaceuticals,
Karachi.
Documents related
to source have not
been provided for
current
application.
7 053031 Nalcam 7.5mg tablets Rs.55.00/10 Initial date Dy.No.3410

’s of
Reg.
Meloxicam ……7.5mg Rs.20,000/-
29-10-2008
(USP Specifications)
Last
Renewal
16-10-2018
8 053032 Nalcam 15 mg tablets Rs.96.00/10 Initial date Dy.No.3411
’s of
Reg.
Meloxicam ……15mg Rs.20,000/-
29-10-2008
Last
Renewal
16-10-2018
9 053034 Nortic Tablets Rs.90.00/10 Initial date Dy.No.3401

’s of
Reg.
Norfloxacin………400mg Rs.20,000/-
29-10-2008
(USP – Specification) Standard
Last formulation
Renewal approved by
RRAs is “film
16-10-2018 coated”
10 053037 Andin Tablets Rs.45.00/10 Initial date Dy.No.3403

’s of
Reg.
Loratadine……….10mg Rs.20,000/-
29-10-2008
(USP Specification) Standard
Last formulation
Renewal approved by
RRAs is “film
16-10-2018 coated”
11 053038 Andin Syrup Rs.48.00/60 Initial date Dy.No.3402

ml of
Reg.
Loratadine……….5mg Rs.20,000/-
29-10-2008
(USP Specification)
Last
Renewal
16-10-2018
12 067696 Peficin 400mg Tablet Rs.222/10’s Initial date Dy.No.3404
Each tablet contains: of 11-02-2019
Pefloxacin …………400 mg Reg. Rs.20,000/-
(Manufacturer’s 16-04-2011
Specification)
Last
Renewal
06-04-2016
13 067697 Nimovas 30mg Tablet Rs.150/10’s Initial date Dy.No.3405

of
Each tablet contains: Rs.300/20’s 11-02-2019
Reg.
Nimodipine ……….30 mg Rs.450/30’s Rs.20,000/-
16-04-2011
(Manufacturer’s
Specification) Last
Renewal
07-04-2016
14 061991 Speny Syrup Rs.95/60ml Initial date Dy.No.3406

of
Reg.
Iron Protein succinylate Rs.20,000/-
800mg eq. to elemental 17-09-2010
Iron……..40 mg
Last
(Manufacturer’s Renewal
Specification)
11-09-2015
15 013791 Glamet Tablet 150mg Rs.49.25/10 Initial date Dy.No.06

’s of
Each film coatedtablet 12-02-2019
contains: Reg.
Rs.20,000/-
Ranitidine (as 17-11-1992
Hydrochloride)…150mg
Last
Renewal
25-10-2017

iii. Section approval (Tablet & Liquid Syrup)of M/s. Reign, Pharmaceuticals TBIC PCSIR
(Pvt) Ltd., Karachi verified from panel inspection report dated 28-11-2013.
iv. Copy of last GMP inspection report of M/s. Reign, Karachi dated 08th November, 2017
indicating “Good” level.
vi. DML of M/s. Reign, Karachi dated 28th November, 2012 with renewal applied on 26-09-
2017.
vii. Licensing Division’s Letter F.No.2-3/88-Lic (Vol-III) as evidence for validity of DML of
Company, Karachi to M/s. Zafa Pharmaceutical Laboratories (Private) Ltd.,
Karachi.
M/s. Zafa Pharmaceutical Laboratories (Private) Ltd., Karachi (DML# 000513) has
requested for change of registration status of following products from M/s. Spencer & Company,
D-105, SITE, Karachi to their name. The details are given as under:
Pack/MRP History
I II III IV V VI
1 035455 Ficobal Injection Rs.460.00/10x Initial date of Dy.No.3417

1ml
Each 1ml ampoule Reg. 11-02-2019
contains:
23-12-2004 Rs.20,000/-
Mecobalamine….500ug
Last Renewal
18-12-2014
2 035456 Ficobal 500mcg Tablets Rs.573.00/10x Initial date of Dy.No.3418

10’s
Each tablets contains: Reg. 11-02-2019
Mecobalamine...500mcg 23-12-2004 Rs.20,000/-
Last Renewal Standard

Formulation
18-12-2014 approved by
RRAs is sugar
coated,
however the
firm has
applied for
“film coated
tablet”.
JP monograph
is available for
Mecobalamin
Tablet.

iii. Section (Tablet & Injectable) approval of M/s. Zafa Pharmaceutical Laboratories
(Private) Ltd., Karachi (DML# 000513), verified from Panel Inspection Report for
grant of GMP certificate dated 28-11-2016.
iv. Copy of last GMP inspection report of M/s. Zafa, Karachi dated 03-01-2018 indicating
“Good” level.
vi. DML of M/s. Zafa, Karachi dated 26-06-2013 with renewal applied on 26-09-2017.
vii. Licensing Division’s Letter F.No.2-3/88-Lic (Vol-III) as evidence for validity of DML of
Case No.16. Request For Change in Registration Status of Products From M/s Novartis
Pharma (Pakistan) Ltd., Karachi To M/s GlaxoSmithKline OTC (Pvt) Ltd.,
Karachi
Registration Board, in its 269th meeting held on 27-28th April, 2017, deferred the
request of M/s GlaxoSmithKline OTC (Pvt) Ltd., 35 Dockyard Road, West Wharf, Karachi
74000 for change in registration status of a number of products from M/s Novartis Pharma
(Pakistan) Ltd., 15-West Wharf, P.O Box 100 & 7247, Karachi-74000, (which the firm was
manufacturing at Jamshoro Plant) as per following details:
Products neither approved in Reference Regulatory Authorities/Agencies nor available in
monograph of any Pharmacopoeia of Reference Regulatory Authorities/Agencies.
S. No Reg. Name of drug(s) & Initial Deferred for Current

No. Composition Registrati Renewal Status/
on Letter International
Date Availability
(as presented in
M-269)
1. 024662 Triaminic-Chest Congestion 26.07.2002 Deferred for Double Strength
Cough Syrup approval status Available in
Each 5ml contains: in reference MHRA UK
Pseudoephedrine HCl regulatory
…..15mg authorities Exact reference
Guaifenesin……..50mg /agencies. not available
2. 024663 Triaminic-Cold and Allergy 26.07.2002 Deferred for Double Strength
Syrup approval status Available in
Each 5ml contains: in reference MHRA UK
Pseudoephedrine regulatory
HCl…..15mg authorities Exact reference
Chlorpheniramine /agencies. not available
Maleate……1mg
3. 024661 Triaminic-Cough Syrup 26.07.2002 Deferred for Double Strength
Each 5ml contains: approval status Available in
Pseudoephedrine HCl in reference MHRA UK
…..15mg regulatory
Dextromethorphan HB authorities/agen Exact reference
r…..5mg cies. not available
4. 000510 Tandegyl Syrup 17.04.1976 Deferred for Double Strength
Each 5ml contains:- approval status Available in
Clemastine … 0.25mg in reference MHRA UK
(as Hydrogen Fumarate) regulatory Exact reference
authorities/ not available
agencies.
5. 006432 Triaminic-Syrup 11.07.1982 Deferred for Different
Each 5ml contains: approval status Combinations
Pseudoephedrine in reference available in TGA
HC1..30mg regulatory Australia
Pheniramine Maleate authorities/agen
…12.5mg cies.
6. 035413 Triaminic Flu, Cough and 15.01.2005 Deferred for Different
Fever Syrup approval status Combinations
Each 5ml contains: in reference available in TGA
Paracetamol……160mg regulatory Australia
Pseudoephedrine HCl authorities/agen
……15mg cies.
Dextromethorphan HBr
……….7.5mg
7. 014317 Triaminic Tablet (Triaminic 17.10.1993 Verification of Renewal status
Sandoz Tablets) name fee challans OK in light of
change dated 03.05.2008 and approval Registration
Each tablet contains: status of Board’s Decision
Pheniramine Reference taken in 264th
Maleate……..25mg Regulatory meeting
Pseudoephedrine HCl Authorities
………7.5mg Different
combinations
available in TGA
Australia
8. 000172 Neo-Intestopan Syrup 20-05- Deferred for Molecule in
Each 10 ml contains: 2016 approval status Health Canada as
Attapulgite…1 gm in reference submitted by firm
regulatory
authorities/agen
cies.
9. 002406 Optalidon Tablet 17.04.1989 Deferred for Reference not
Each tablet contains: approval status available
Propyphenazone..175mg in reference
Caffeine Anhydrous…25mg regulatory
authorities/agen
cies.
10. 000937 Spasmo Cabalgin tablets 18.03.1980 Deferred for Reference not
Each tablet contains:- approval status available
Propyphenazone … 220mg in reference
Hexahydroediphenine HCl regulatory
… 20mg authorities/age
ncies.
11. 007719 Tandegyl-D tablet 12.11.1984 Deferred for Reference not
Each tablet contains: approval status available
Clemastine (as Hydrogen in reference
Fumarate)…..1mg regulatory
Pseudoephedrine authorities/agen
HCl….90mg cies.
12. 008949 Neo Intestopan Tablets 25.11.1986 Renewal Molecule in
Each tablet contains:- application Health Canada as
Activated received within submitted by firm
Attapulgite……..0.630gm stipulated time
accompanied
with prescribed
fee.
Decision of M-269: Mr. Mazhar Shams, Regulatory Manager, GlaxoSmithKline OTC (Pvt)
Ltd., Jamshoro appeared before the Board and shared the approval status
of their above mentioned applied products in Reference Regulatory
authorities/agencies as mentioned in the last column of the above table.
He also mentioned that although certain cough syrups are approved in
reference regulatory authorities but in double strengths to their applied
products in Pakistan. Registration Board asked the representative of the
firm to submit safety and efficacy justification of half dose of certain
APIs in the formulation which they applied for registration. In response
to which, Mr. Mazhar Shams sought time of 20 days from Registration
Board to submit safety and efficacy data of the product mentioned in the
above table.
Keeping in view the availability of medicine, Registration Board acceded to this request of
firm’s representative and directed him to submit the requisite data within 20 days for
aforementioned products for further consideration of the Registration Board.
Formulation at S.No.12 i.e., of Neo Intestopan Tablets (R#008949) is licensed as a

natural health product in Canada while for product at S.No.09 i.e., Optalidon Tablet (R#002406)
the approval status of formulation has been confirmed in Spanish Medicine Agency “As Dragees”.
Registration-II
Case No.1: Registration of Products of M/s Tagma Pharma (Pvt) Ltd, Lahore.
Registration Board in its 283rdmeeting held on 27th -29th June, 2018 considered the following
product of M/s TagmaPharma Lahore for registration and decided as as per detailed below:-
Sr. Name of Product & Composition Demanded Demande Decision
No. Pack size d MRP
1 Butag Tablets 5×10’s As Per Approval
Each tablet contains:- SRO status in
Buprenorphine as HCl ……………….0.2mg reference
countries not
confirmed
Decision
(M-226)
Approved
subject to
fulfillment of
policy
Now the Firm has submitted documented evidence that Buprenorphine HCl 200 microgram is
approved as uncoated tablet (Route of Administration: sublingual) by Therapeutic Good
Administration, Australia. Firm has requested for issuance of registration letter.
Submitted for consideration of Registration Board, please.
Case No.2: Registration of Products of M/s Mediceena Pharmaceuticals Pvt Ltd. Lahore.
Registration Board in its 234th meeting held on 16-07-2012 approved the following Products of
M/s. Mediceena Pharma, Lahore and decided as under:-
S. No. Name of Drugs & Composition Demanded MRP Decision

& Pack Size
1. Klaridox Injection 1’s Approved subject to

Each vial contains:- As per SRO verification of dry powder
Clarithromycin Lactobionate eq.to injection General from
Clarithromycin...........500mg
Licensing Section.
(antibiotics)
2. Lyphocin Infusion 1’s Approved subject to
Vancomycin hydrochloride eq. to injection General from
vancomycin….1gm
Licensing Section.
(antibiotics)
3. Rabizol Injection 1’s Approved subject to
Rabeprazole..................20mg injection General from
Licensing Section.
4. Fosfomin Injection 1’s Approved subject to

Fosfomycin Sodium eq.to injection General from
fosfomycin….................1gm
Licensing Section.
5. Azimycin Injection 10ml Approved subject to

Azithromycin dehydrate eq. to injection General from
Azithromycin…......250mg
Licensing Section.
(Macrolides (Antibiotics)
Firm has submitted following documents and requested for issuance of registration letters for
above mentioned
i. Differential fee of Rs. 12000/- for each product deposited (Yellow copies)
ii. GMP inspection reports conducted on dated 28-05-2013 and 14-07-2014 which
are reflecting that firm has Dry Powder Injection (General) as dedicated area for
manufacturing of dry powder injections.
Submitted for consideration of Registration Board, please.
Import & Veterinary Section
HUMAN CASES
Case No. 01:- Registration of Clozaril Tablet 25mg & 100mg by M/s. AGP Ltd,
Karachi.
M/s. AGP Limited, B-23-C, SITE, Karachi hassubmitted application for registration of
Clozaril 25mg & 100mg Tablet from the name of M/s.Novartis Pharma (Pakistan) Limited,
Karachi to their own name. Detail of each product is as under: -
Product-1: Clozaril 25mg Tablet (Reg.No.016329)
S.
Name / Detail of Documents Documents / Information Provided by Firm
No.
1. Product Name / Composition Clozaril 25mg Tablet
Clozapine…….25mg
2. Name and address of Applicant M/s AGP Limited B-23-C, SITE, Karachi.
(transferee)
3. Name of Transferor M/s Novartis Pharma (Pakistan) Limited, 15-West Wharf Road,
Karachi.
4. Detail of Drug Sale License M/s AGP Limited B-23-C, SITE, Karachi
5. Name and address of M/s Novartis Saglik, GidaVeTarimUrunleriSanayiveTicaret
manufacturer. A.S. (Novartis Urunleri) YenisehirMahallesiDedepasaCadessi
N 17 34912 Kurtkoy, Istanbul, Turkey (Pg-91/Corr).
6. Name and address of marketing M/s BGP Products GmbhNeuhofstrasse 23 6341 Baar
authorization holder Switzerland.
7. Name of exporting country Turkey
8. Diary No. & Date of R&I Dy. No. 43856 Dated 26-12-2018
9. Finished Product Specification Manufacturer specifications
10. Shelf life 36 months
11. Pack Size 50’s Tablet
12. Remarks:
 Firm has requested manufacturer specifications however, the said formulation is included
in USP.
Product-2: Clozaril 100mg Tablet (Reg.No.016330)

S.
Name / Detail of Documents Documents / Information Provided by Firm
No.
1. Product Name / Composition Clozaril 100mg Tablet
Clozapine…….100mg
2. Name and address of Applicant M/s AGP Limited B-23-C, SITE, Karachi.
(transferee)
3. Name of Transferor M/s Novartis Pharma (Pakistan) Limited, 15-West
Wharf Road, Karachi.
4. Detail of Drug Sale License M/s AGP Limited B-23-C, SITE, Karachi
5. Name and address of M/s Novartis Saglik,
manufacturer. GidaVeTarimUrunleriSanayiveTicaret A.S. (Novartis
Urunleri) YenisehirMahallesiDedepasaCadessi N 17
34912 Kurtkoy, Istanbul, Turkey (Pg-91/Corr).
6. Name and address of marketing M/s BGP Products GmbhNeuhofstrasse 23 6341 Baar
authorization holder Switzerland.
7. Name of exporting country Turkey
8. Diary No. & Date of R&I Dy. No. 43857 Dated 26-12-2018
9. Finished Product Specification Manufacturer specification
10. Shelf life 36 months
11. Pack Size 50’s Tablet
12. Remarks:
 Firm has requested manufacturer specifications however, the said formulation is
included in USP.
The firm has submitted the following supporting documents / information for approval
of registrations of above mentioned products: -
a) Fee of Rs. 100,000/- (for each product)

b) Applications on Form-5A.
c) Copy of initial registration letters with complete post registration variation and
renewal status.
d) Authority letter (original & notarized) issued by Product License Holder (M/s. BGP
Products GmbH) for new proposed sole agent (M/s AGP Ltd, Karachi)
e) Original & legalized CoPPs for above products issued by Swissmedic.
f) Copy of GMP certificate of M/s Novartis Saglik, GidaVeTarimUrunleriSanayiveTicaret
A.S. (Novartis Urunleri) YenisehirMahallesiDedepasaCadessi N 17 34912 Kurtkoy,
Istanbul, Turkey issued by Turkish Ministry of Health.
g) Copy of valid DSL.
h) NOC (original) from M/s Novartis Pharma (Pakistan) Limited, 15-West Wharf Road,
Karachi infavor of M/s AGP Ltd, Karachi(dated 25th October, 2018)
It is pertinent to inform that the firm has not provided termination letter from the
manufacturer/product license holder in favor of current importer i.e M/s. Novartis Pharma
(Pakistan) Ltd, Karachi.
Submitted for consideration of Registration Board.
Case No.02:- Request of M/s. Novartis Pharma (Pak) Ltd, Karachi for Correction
of manufacturing site for their registered product Tobradex
(Ophthalmic) ointment (Reg.No.094745).
M/s. Novartis Pharma (Pakistan) Ltd, Karachi has informed that the name of
manufacturing site granted to them vide letter No.F.3-2/2018-Reg-I (M-279)/Human Import
dated 11-01-2019 for product Tobradex (Ophthalmic) ointment is mentioned incorrectly as “M/s.
Alcon Cusi, S.A. CamilFabra 58 08320 EI Masnou - Barcelona Spain” in registration
letterinstead of “M/s SA Alcon-Courveur NV, Rijksweg 14, B-2870 Puurs, Belgium”.
The manufacturer “M/s. Alcon Cusi, S.A. CamilFabra 58 08320 EI Masnou - Barcelona
Spain” was inadvertently incorporatedagenda &minutes of the meeting (M-279) for product
Tobradex (Ophthalmic) Ointment.
Accordingly the correct/demanded manufacturer i.e “M/s SA Alcon-Courveur NV,
Rijksweg 14, B-2870 Puurs, Belgium” for product Tobradex (Ophthalmic) Ointment has been
granted to the firm via corrigendum.
Submitted for information of Registration Board.
Case No.03:- Request of M/s. Apex Pharmaceutical (Pvt) Ltd, Karachi for
registration of products in their name.
The case of M/s. Apex Pharmaceuticals (Pvt) Ltd, Karachi was presented in 286 th
meeting of Registration Board for registration of Azastrole 1mg Tablet, Bicalox 50mg Tablet
&Gynotril 2.5mg Tablet from the name of M/s MerixilPharma to their own nameas under: -
Product-1: Azastrole 1mg Tablet (Reg.No.081807)
S# Name / detail of documents Documents / information provided by firm
1. Product Name / Composition Azastrole 1mg Tablet
Anastrozole…..1mg
2. Name and address of Applicant M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super
(transferee) Highway, Karachi.
3. Name of Transferor M/s. MerixilPharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad.
4. Detail of Drug Sale License M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21, A/1, SITE, Super
Highway, Karachi.
5. Name and address of As per initial registration letter:-
manufacturer. M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
Melbourne VIC 3205, Australia.
As per Form-5A &CoPP
Manufacturing Site
M/s. Douglas Manufacturing Ltd, Central Park Drive Lincoln
Auckland, New Zealand.
Marketing authorization holder & release for supply:-
M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
Melbourne VIC 3205, Australia.
6. Name and address of marketing M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
authorization holder (as per Melbourne VIC 3205, Australia.
Form-5A)
7. Name of exporting country Australia
8. Diary No. & Date of R& I Dy. No. 20662 Dated 08-06-2018
9. Finished Product Specification (Manufacturer spec)
10. Shelf life 36 months (as per approval & Form-5A)
11. Pack Size Blister of 30’s Tablets, (as per approval)
12. Remarks:
 The name of manufacturer (as per COPP & Form-5A) differ from the one mentioned in initial
registration letter. However, the firm has informed that now manufacturing will be performed by
M/s. Douglas Manufacturing Ltd, Central Park Drive Lincoln Auckland New Zealand while M/s
Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South Melbourne VIC 3205, Australia is the
legal license holder of the product.
Product-2: Bicalox 50mg Tablet (Reg.No.081809)
1. Product Name / Composition Bicalox 50mg Tablet
Bicalutamide…..50mg
2. Name and address of Applicant M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super
3. Name of Transferor M/s. MerixilPharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad.
4. Detail of Drug Sale License M/s. Apex Pharmaceuticals (Pvt) Ltd, D-21, A/1, SITE, Super
Highway, Karachi
5. Name and address of Same as in product 1
manufacturer
6. Name and address of marketing M/s. Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
authorization holder Melbourne VIC 3205, Australia.
9. Finished Product Specification USP Specifications
11. Pack Size 28’s & 10’s
12. Remarks:
 Same as for product 1
Product-3: Gynotril 2.5mg Tablet (Reg.No.081808)
1. Product Name / Composition Gynotril 2.5mg Tablet
Each film coated tablet contains
Letrozole …..2.5mg
2. Name and address of Applicant M/s Apex Pharmaceuticals (Pvt) Ltd, D-21-A/1, SITE, super
3. Name of Transferor M/s MerixilPharma, Office No. 28, 2nd Floor, Rose Plaza I-8
Markaz, Islamabad.
4. Detail of Drug Sale License M/s Apex Pharmaceuticals (Pvt) Ltd, D-21, A/1, SITE, Super
Highway, Karachi
5. Name and address of Same as in product 1
manufacturer
6. Name and address of marketing M/s Eris Pharmaceutical (Australia) Pty Ltd, 6 Eastern South
authorization holder Melbourne VIC 3205, Australia.
9. Finished Product Specification USP Spec
11. Pack Size 30’s
12. Remarks:
 Same as for product 1
The firm has submitted the following supporting documents / information for approval
of registration of above mentioned products: -
a) Fee of Rs.100,000/- for each product.
b) Applications on Form-5A.
c) Copy of initial registration letter (renewal valid as registration granted on
15-09-2016).
d) Copy of Termination letter from manufacturer / product license holder in favor of
current registration holder i.e. M/s. MerixilPharma, Islamabad.
e) Authority letter (original & notarized) issued by manufacturer / product license
holder for new proposed sole agent.
f) Original & legalized CoPPs for above products issued by TGA Australia.
g) Original GMP certificate of M/s Douglas Manufacturing Ltd, New Zealand issued
by Ministry of Health, New Zealand.
h) Copy of valid DSL.
i) NOC from M/s. MerixilPharma, Office No. 28, 2nd Floor, Rose Plaza I-8 Markaz,
Islamabad issued on 26th December, 2017.
Registration Board in its 286th meeting decided to deferthe case for provision of fresh NOC
from the current registration holder as more than six months have elapsed for the available NOC
(dated 26th December, 2017) and original notarized termination letter from product license
holder.
Now the firm has submitted fresh NOC from current registration holder (i.e. M/s.
MerixilPharma, Office No. 28, 2nd Floor, Rose Plaza I-8 Markaz, Islamabad) issued on19th
September, 2018 and termination letter in original (notarized) from product license holder in
favor of current registration holder as per decision of Registration Board.
With reference to product-1 it is submitted that the same has already been granted
registration in favor of M/s. RG Pharmaceutical (Pvt) Ltd, Karachi with brand name “DP-
Anastrozole 1mg Tablets” Reg.No. 080918 from the same manufacturer i.eM/s. Douglas
Manufacturing Ltd., Central Park Drive Lincoln, Auckland, New Zealand, dated:10-02-2017.
Case No.04:- Request of M/s. OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, Site
Karachi for change of manufacturing site of Cosopt Ophthalmic Solution.
M/s OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, SITE Karachi has applied for
change of manufacturing site of their following already registered product as per details given
below: -
Product Name & Existing approved New Proposed Site /

S. Reg.
Composition site Manufacturer / Product
# No.
(as per approval letter) License Holder
1. 025294 Cosopt Ophthalmic Manufacturer: Name & Address of

Solution M/s Laboratoires Merck Manufacturer:
Each ml contains: Sharp &Dohme- Chibret, M/s Santen
22.26mg Dorzolamide Route de Marsat, Riom, Pharmaceutical Co., Ltd.
HCL eq to 63963 Clermont Noto Plant,
Dorzolamide 20mg FerrandCedex 9, France. 2-14, Shikinami,
base. Marketing Authorization Hodatsushimizu-cho,
6.83mg Timolol Holder: Hakui-gun, Ishikawa,
Maleate USP eq to 5mg M/s MSD France, 34, Japan.
Timolol base. avenue Leonard de Vinci, Marketing
92400 Courbevoie, France. Authorization Holder:
M/s Santen
OyNiittyhaankatu 20
33720 Tampere, Finland
The firm has submitted the following supporting documents: -

a) Application on Form-5A.
b) Fee of Rs.100,000/-
c) Copy of initial registration letter and renewal status.
d) Original and legalized COPPs issued by Japanese Authority & Finnish
Medicine Agency.
e) Copy of GMP certificate of new site (issued by Japanese Authority).
f) Authorization letter in the name of M/s OBS Pakistan Pvt (Ltd) Karachi, from
new manufacturer i.e. M/s Santen Pharmaceutical Co., Ltd, Japan.
g) Site master file for new site.
With reference to the above mentioned product, it is informed that initially the firm has
provided COPP from Japanese Authority wherein, it is mentioned that the product is not on free
sale in exporting country i.e. Japan. In order to provide Free sale status of the said product in
reference regulatory authority the firm has provided valid legalize COPP issued by Finland
Medicine Agency.
Furthermore, the request of M/s OBS Pakistan for change of marketing authorization
holder for the said product has already been approved by Registrations Board in its 282ndmeeting
fromM/s. MSD France, 34 Avenue Leonard de vinci, 92400 Courbevoie, France to M/s. Santen
Oy, Niittyhaankatu 20, 3370 Tampere, Finland which is also evident in the new submitted COPP
(issued by Finnish Authority).
Case No.05:- Request of M/s. Getz Pharma (Pvt) Ltd, Karachi for registration of
Product in their own name.
The case of M/s. Getz Pharma (Pvt.) Limited 29-30/27, Korangi Industrial Area Karachi
for registration of following imported human product in its name and cancellation of the same
from the name of M/s. Abbott Laboratories (Pakistan) Limited, Opposite: Radio Pakistan
Transmission Centre, Hyderabad Road, Karachi was discussed in 279th meeting of Registration
Board. Details are as under.
S. Reg. Name & Name & Manufacturer/product Manufacturer/product

No. No. Composition of Composition of license Holder (as per license Holder.
Products (as per Products (as per registration letter) (as
initial CoPP)
registration
letter)
1. 025293 Lucrin Depot Lucrin Depot Manufacturer: Product license holder:
3.75mg Injection PDS 3.75mg M/s. Tekeda M/s. AbbvieFarmaceutica,
Each vial Injection Pharmaceutical S.L.U. Avda. de Burgos, 91
contains:- Each vial Company Limited 28050 Madrid , Spain.
Leuprorelin contains:- Osaka, Japan. Manufacturer:
Acetate…3.75mg Leuprolide (manufacturer of vial &
Acetate…3.75mg ampoules):
M/s. Takeda Pharmaceutical
Company Ltd. 1-1
Doshomachi 4-chome, 540-
8645 Chuo-ku, Osaka, Japan.
Packaging of Finished
Product:
M/s. Abbott Laboratories,
S.A. Avda. De Burgos, 91,
28050 Madrid Spain.
The firm has deposited fee of Rs. 1,00,000/- and provided the following supporting
documents:
i. Application on Form 5A.
ii. Copy of registration letters and last renewal status. With reference to
renewal it is submitted that Renewal is due in Nov-2015. However, the
firm had applied for registration of the product in their name in Aug-2015.
Therefore, keeping in view the previous decisions of Board in such cases,
the renewal may consider as valid.
iii. Termination letter (original) from manufacturer for previous importer.
iv. Authority letter/sole agent letter (original) from manufacturer.
v. NOC from existing registration holder for transfer of registration (issued
on 18-9-2014).
The case was considered in 277th meeting of Registration Board and the Board decided as
under:
“Keeping in view the previous decisions of Registration Board in such cases, Board deferred the
case for provision of fresh NOC from existing registration holder i.e M/s. Abbott Laboratories
(Pakistan) Limited, Karachi as the already submitted NOC was issued in September 2014.”
In compliance to Registration Board decision, the firm submitted fresh NOC (dated: 12-
01-2018) from the M/s. Abbott Laboratories (Pakistan) Limited, Karachi.
The case was considered in 29th meeting and the Board decided to advised the firm for
provision of valid, legalized and attested CoPP for the said product.
In light of above decision the firm has submitted original and legalized CoPP, wherein
the following points were observed to which the firm has replied as under (mentioned in remarks
column).
S. Details As per previous As per new COPP Remarks (reply from firm)
No COPP
1 Brand Name Lucrin Depot PDS Lucrin This is to inform you that the brand name in
in Pakistan Pakistan is “Lucrin Depot”. However,
erroneously in the COPP it is mentioned only
“Lucrin”.
2 Product M/s. M/s. This is to inform you that in October, 2014,
Licesne AbbvieFarmaceutica, AbbvieFarmaceutica, name of M/s AbbvieFarmaceutica S.L.U. has
Holder S.L.U. Avda. de S.L.U. Avda. de been changed to M/s Abbvie Spain S.L.U.
Burgos, 91 28050 Burgos, 91 28050 Firm has provided copy of approval letter /
Madrid , Spain. Madrid , Spain. notification issued by Spanish Agency for
Medications and Healthcare.
3 Manufacturer M/s. Takeda M/s. Takeda Kindly note that there is no change in the
(Manufacturer Pharmaceutical Pharmaceutical manufacturing site. However, previous COPP
of vial & Company Ltd. 1-1 Company Ltd, Osaka contains company’s / head office address and
ampoule) Doshomachi 4- Plant, 1785, Juso- not the manufacturing plant’s address. The
chome, 540-8645 Honmachi, 2-Chome manufacturing plant address is mentioned in
Chuo-ku, Osaka, Yodogawa-ku Osaka new COPP.
Japan. 532-0024,
Japon/Japan.
Case No.06:- Request of M/s. Al-Hameed Agencies (Pvt) Ltd, Rawalpindi for
Change of Address (Local) for their registered products.
M/s Al-Hameed Agencies (Pvt) Ltd, Rawalpindi has requested for change of local
address for their following registered products as per following details:-
S. Name & Address of Proposed Name &

Reg.
Name of Drug/ Composition Importer (as per Address of Importer
No No.
Previous DSL) (as per New DSL)
1. 021092 Intapan Injection M/s Al-Hameed M/s Al-Hameed
Each ml contains:- Agencies (Pvt) Ltd, 187- Agencies (Pvt) Ltd, 20,
NalbuphineHCl 10mg C, Rashid Minhas Road Opp, Ayub National
2. 025295 Torapan 30mg Injection (Mayo Road) P.O. Box Park, Jhelum Road,
Each 1 ml ampoule contains: - No. 808, Rawalpindi. Rawalpindi.
Ketorolac Trometamo 30mg
3. 025296 Monasan 25mg Injection
Each 1 ml ampoule contains: -
FluphenazineDecanoate 25mg
The firm has deposited fee of Rs.5000/- (for each product)and submitted
following documents:-
a) Copy of DSL of previous distribution address.
b) Copy of DSL of new / proposed distribution address.
c) Initial registration letters and renewal trail.
Case No. 07:- Request of M/s.Medi Mark Pharmaceuticals, Sahiwal for change of address
(local) for their registered product.
M/s. Medi Mark Pharmaceuticals, Sahiwal has requested for change of localaddress for
their following registered product as per following details:-
S. Reg. Name of Drugs/ Name & Address of Proposed Name &

No No. Composition importer Address of Importer
(as per initial registration (as per New DSL)
letter)
1. 031302 Dobamin Injection M/s. Medi Mark M/s. Medi Mark
Each ampoule contains:- Pharmaceuticals, Pharmaceuticals, 588/B1,
Dobutamine as 6-Civic Centre, Moon LiaquatChowk, Karbala
HCI…..250mg Market, Gulshan-e-Ravi,
Road, Sahiwal.
Lahore.
Firm has deposited fee of Rs. 5000/- and provided the following documents:-
(i) Copy of initial registration letter.

(ii) Copy of last renewal status.
(iii) Copy of Drug Sale License (new and old DSL)
It is pertinent to inform that inspection of local storage facility located at “588/B1,

LiaquatChowk, Karbala Road, Sahiwal” has already been verified by the concerned FID.
Case No.08:- Registration of Drugs under the Drugs Act, 1976-Inspection reports of
Manufacturer Abroad.
The Registration Board approved drugs in various meetings subject to inspection of

manufacturer abroad as per import policy. The inspections were accordingly carried out by the
approved inspection panel. The following panel inspection reports of manufacturer abroad have
reported certain observations as per details mentioned below:-
(A) M/s. Cisen Pharmaceutical Co. Ltd. Tongji Tech Industry Garden, Jining High &
New Technology Industrial Development Zone, Jining, Shadong, China.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/

No. Manufacturer & Date of inspection
meeting number
1. M/s. Mehran Ondansetron injection 8mg/4ml (i) Dr.
International, Pliva FakhruddinAamir,
Avenue Hume Road Each 4ml ampoule contains:- Additional Director,
Near World Map Drug Regulatory
Ondansetron Hydrochloride eq. to
Karachi./ Authority of
Ondansetron………...8mg
Pakistan,
Manufacturer & Islamabad.
Approved with USP specifications
Marketing (ii) Mr.Zaheer-ud-Din
and a shelf life of 2 years as per
Authorization Muhammad Babar,
Policy for inspection of
Holder:- Deputy Director,
Manufacturer abroad. The
inspection panel may be requested to Drug Regulatory
M/s. Cisen
verify the following: Authority of
Pharmaceutical Co. Ltd.
Pakistan,
Tongji Tech Industry
Real-time stability study data Islamabad.
Garden, Jining High &
(conducted as per Zone IV-A) of 3
New Technology
batches 17051, 17052 and 17053
Industrial Development
which were manufactured in May 7th& 8th December, 2018
Zone, Jining, Shadong,
2017.
China.
Impact of the difference in the
specifications on which stability
studies were conducted (i.e. Chinese
Pharmacopoeia) and the
specifications which are approved by
Registration Board (i.e. USP
specification).
Test Submitted USP

specification specification
pH 3–4 3.3 – 4
Assay 93 – 107% 95 – 105%
Ofloxacin infusion 200mg/100ml

Each 100ml infusion bottle contains:-
Ofloxacin…200mg/100ml
Ciprofloxacin infusion 200mg/100ml

Each 100ml infusion bottle contains:-
Ciprofloxacin lactate eq to
ciprofloxacin……200mg
Omipen Injection 40mg
Each vial contains:-
Omeprazole sodium eq to omeprazole
(lyophilized powder)………..40mg
Comments/ Remarks of the Panel.
(i) The CoPP of all the four products i.e. Ondansetron Injection 8mg/4ml, Ofloxacin Infusion
200mg/100ml, Ciprofloxacin Infusion 200mg/100ml and Omipen Injection 40mg mentions
manufacturer and product license holder as Cisen Pharmaceutical Co., Ltd, Tongji Tech-
Industry Garden, Jining High & New Technology Ind. Development Zone, Jining. Shandong
Province. However, Ondansetron Injection 8mg/4ml, Ofloxacin Infusion 200mg/100ml and
Ciprofloxacin Infusion 200mg/100ml are manufactured at the premises situated at
HaichuanRoad,Jining High & New Technology Industries Development Zone, while Omipen
Injection 40mg is manufactured at premises located mentioned in the CoPP, which is few
street away from the Haichuan Road premises. The management of the firm informed that
the COPP are issued at the legal / Head Office address, which in this case is, Tongji Tech-
Province, while the GMP certificate mentions the manufacturing site and facilities. The
manufacturing and quality control facilities at Cisen Pharmaceutical Co., Ltd, Tongji Tech-
Province premises appears to comply GMP requirements as observed at the time of visit.
(ii) The report of Haichuan Road Jining High & New Technology Industries Development Zone,
which manufactures ,Ondansetron Injection 8mg/4ml, Ofloxacin Infusion 200mg/100ml and
Ciprofloxacin Infusion 200mg/100ml was submitted on separate proforma, which, in addition
to above details reported that the manufacturing and quality control facilities at Haichuan
Road Jining High & New Technology Industries Development Zone premises appears to
comply GMP requirements as observed at the time of visit.
(iii)With regards to specification of ondansetron Injection 8mg/4ml, the management informed
that they follow the in-house specifications, which are at par with USP. The firm has also
provided a copy of the documents relating to real time stability study of three batches of
ondansetron Injection 8mg/4ml in support of its aforementioned claim (Appended). The
stability data indicates that a specification including those of pH and Assay comforms to
USP.
As per CoPP and Form-5A submitted by the applicant the name and address of the
manufacturer and product license holder of all the above four products is as under:-
 M/s. Cisen Pharmaceutical Co. Ltd. Tongji Tech Industry Garden, Jining High & New
Technology Industrial Development Zone, Jining, Shadong, China.
While as per copies of GMP certificate submitted to the inspection panel by the firm the
manufacturing site addresses are as under: -
 M/s. Cisen Pharmaceutical Co. Ltd. Tongji Tech Industry Garden, Jining High & New
Technology Industries Development Zone.
Lyophilized Powder for Injection; small volume parenteral solution(terminally sterilized
non-terminally sterilized, including hormones).
 M/s Haichuan Road, Jining High & New Technology Industries Development Zone.
Small volume parenteral solutions; large volume parenteral solutions (vertical
plypropylene infusion bag, jubingxiShuye Ping PP Infusion Bottles).
Submitted for consideration of the Board.
B. M/s. Shijiazhuang No. 4 Pharmaceutical Co., Ltd., No. 288, Zhujiang Road, High
Tech Industrial Development Zone, Shijiazhunang, Hebei, China.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/

No. Manufacturer & Date of inspection
meeting number
1. M/s. S.K. Enterprises, SK+METROSIM Infusion (i) Dr. FakhruddinAamir,
Office No. 701, 7th floor KS Solution for IV infusion Additional Director,
trade tower, Shahrah e Each 100 ml contains:- Drug Regulatory
Liaquat Karachi./ Metronidazole…500mg Authority of Pakistan,
(ANTIPROTOZOALS) Islamabad.
M/s. Shijiazhuang No. 4 (ii) Mr.Zaheer-ud-Din
Pharmaceutical Co., Ltd., SK+CIPROSIM Injection Muhammad Babar,
No. 288, Zhujiang Road, Solution for IV Injection Deputy Director, Drug
High Tech Industrial Each 100 ml contains:- Regulatory Authority
Development Zone, Ciprofloxacin (as lactate)…200mg of Pakistan,
Shijiazhunang, Hebei, (Quinolones) Islamabad.
China.
SK+RINGERSIM Infusion 10th& 11th December, 2018
Manufacturer & Market Solution for IV Infusion
Authorization Holder:- Each 500ml contains:-
Sodium lactate…….1.6g
M/s. Shijiazhuang No. 4
Potassium chloride..0.2g
Pharmaceutical Co., Ltd.,
Calcium chloride
No. 288, Zhujiang Road,
dehydrate……….0.135g
High Tech Industrial
Sodium chloride……3g
Development Zone,
(electrolytes)
Shijiazhunang, Hebei,
China.
(M-278)
Comments/ Remarks of the Panel.
i. The CoPP of all the three products i.e. SK+Metrosim Infusion solution for IV infusion,
SK+Ciprosim Injection solution for IV Injection and SK+Ringersim Infusion Solution for
IV Infusion mentions manufacturer and product license holder as M/s Shijiazhuang No. 4
Pharmaceutical Co., Ltd., No.288 Zhujiang Road, High &New tech Development Zone,
Shijiazhuang, Hebei, China, Yangzi Road, Shijiazhunang Economic and Technological
Development Zone Hebei PRC. The SK+Metrosim Infusion solution for IV infusion and
SK+Ciprosim Injection solution for IV Injection are manufactured at the premises located
at No.288 Zhujiang Road, High-tech Industrial Development Zone, Shijiazhuang while
the product is manufactured at another premises located few streets away having address
M/s Shijiazhuang No. 4 Pharmaceutical Co., Ltd., Yangzi Road, Economic and
Technological Development Zone Shijiazhunang, Hebei, China. However, the Quality
Control and Batch release is done at the premises situated at No.288 Zhujiang Road.
ii. The management of the firm informed that the COPP are issued at the legal address,
which mentions both above premises, while the GMP certificate mentions the
manufacturing site and facilities. The manufacturing facility at No.288 Zhujiang Road,
High-tech Industrial Development Zone, Shijiazhuang are well designed and adequately
equipped having effective system and controls for cGMP compliance.
iii. The report of the premises situated at Yangzi Road, Economic and Technological
Development Zone Shijiazhunang, Hebei, China., which manufactures SK+Ringersim
Infusion Solution for IV Infusion, in addition to above details, states that the
manufacturing facility of SK+Ringersim Infusion Solution is state of art facility and all
the process from dispensing of raw material to the manufacturing of finished products are
automatic with least involvement of workers. The facility have latest HVAC and WFI
system. The firm claims to be the largest manufacturing of IV solutions in china. The
premises appears to comply GMP requirements as observed at the time of visit.
The details regarding manufacturer / MH Holder as per Form-5A, CoPP& GMP submitted by
the firm are as under: -
Manufacturer / MA
Manufacturer / MA Manufacturer as
Product Name Holder as per
Holder as per CoPP per GMP
Form-5A
SK+METROSIM M/s Shijiazhuang No. M/s Shijiazhuang No. M/s Shijiazhuang No.
Infusion 4 Pharmaceutical 4 Pharmaceutical 4 Pharmaceutical
Co., Ltd., No.288 Co., Ltd., No.288 Co., Ltd., No.288
Solution for IV infusion Zhujiang Road, Zhujiang Road, High Zhujiang Road,
Each 100 ml contains:- High-tech Industrial &New tech High-tech Industrial
Development Zone, Development Zone, Development Zone,
Metronidazole…500mg Shijiazhuang, China Shijiazhuang, Hebei, Shijiazhuang,
China, Yangzi Road,
(ANTIPROTOZOALS)
Shijiazhunang
Economic and
Technological
Development Zone
Hebei PRC.
SK+CIPROSIM -do- -do- -do-

Injection
Solution for IV Injection
Each 100 ml contains:-
Ciprofloxacin (as
lactate)…200mg
(Quinolones)
SK+RINGERSIM M/s Shijiazhuang No. -do- M/s Shijiazhuang No.

Infusion 4 Pharmaceutical 4 Pharmaceutical
Co., Ltd., Yangzi Co., Ltd., Yangzi
Solution for IV Infusion Road, Economic and Road, Economic and
Each 500ml contains:- Technological Technological
Development Zone Development Zone
Sodium Shijiazhunang China Shijiazhunang City.
lactate…….1.6g
Potassium chloride..0.2g
Calcium chloride
dehydrate……….0.135g
Sodium chloride……3g
(electrolytes)
VETERINARY CASES
Case No.09:- Contract manufacturing of already registered products:

M/s. P.D.H Laboratories (Pvt.) Ltd, 9.5KmSheikhupura Road, Lahore has requested for contract
manufacturing of their following already registered products from M/s. Intervac (Pvt) Ltd., 18 Km Lahore
Sheikhupura Road, Sheikhupura as per details mentioned below. Citing the reason for the contract
manufacturing, the firm stated that they are in process of developing new dedicated facilities for Oral and
Injectable veterinary sections which hopefully will be completed within the period of two and half years.
S. Name of Name of Drug(s)/ Reg. No./ Approval status Remarks/ Reply of the firm
No. Applicant and Composition& Date of Initial in RRAs and Shortcomings
Manufacturer Pack Size Registration and Me-too status
Renewal status
1. M/s. P.D.H Rimoxyn 002152 Limoxin-50 i) Initial i)Initialregistration
Laboratories (Pvt.) Injection (Vet) Renewal Injection registration certificate is not
Ltd, Each ml submitted as per (Holland, letter not available at this
9.5KmSheikhupura contains:- copies provided. InterchemieWerk provided. time.
Road, Lahore Oxytetracycline 24-09-1985 en)
ii) Regarding the
contract HCI eq. (MOH letter
manufacturing Oxytetracycline… renewal dates not Me-too ii) The renewal letter
from M/s. Intervac ..50mg specified) B.G. Oxy-50 registration (issued in 1985)
(Pvt) Ltd., 18 Km (Composition as 05-10-1986 Injection renewal does not contain
Lahore perForm-5) 25-09-1991 M/s. letter (issued composition, it is
Sheikhupura Road, 08-09-1996 BiogenPharmaR in 1985) to inform you that
Sheikhupura. 2ml 25-09-2001 awat. does not this practice had
50ml (Receipt in MOH contain not practiced by
100ml not provided). detail. the MOH that
19-10-2006 time.
02-11-2011
iii)The
16-11-2016
iii) composition as per
Composition National
and renewal Formulary of
date in Pakistan
National ofOxytetracycline
Formulary of injection is written
Pakistan the by mistake. The
product actual formulation
appear as is “Each ml
Oxytetracycl contains
ine injection Oxytetracycline
having (as HCI) 50mg”
composition which is appliedat
each 2ml the time of
contains registration. Copy
Oxytetracycl of letters for
ine (as HCI) approval of
50mg. additional pack
and new
design/color
scheme are
attached for
reference.
iv) Form-5 is iv)Form 5 dully
signed and signed by the
submitted by contract
M/s. Intervac giver/registration
i.e. contract holder provided.
acceptor.
v) Finished v)Finished product

product specification
specification provided.
not provided.
2. -do- Evomec Injection 043506 a.Bimectin i) First i)Submitted renewal
1% W/V (Canada, renewal due on 06-08-2011 with
Contains:- 18-07-2006 Bimeda-MTC on 17-7-2011 late fee (Rs.8000)
Ivermectin……… Renewal Animal Health was within the validity
1% w/v submitted 06-08- Inc) period of 60 days
submitted on
(Composition as 2011 (Last after expiry date of
per initial renewal Me-too 06-08-2011 renewal. Copy of
registration letter) application Ivotek Injection with fee of challan form is
10ml submission) 1% W/V Rs.8000/- attached for
50ml 15-07-2016 M/s. Star reference.
100ml Laboratories
(Pvt) Ltd. ii) Form-5 is ii) Form 5 dully
Lahore. signed and signed by the
acceptor.
iii) Finished iii) Finished

product product
not provided. provided.
3. -do- Levopower 043507 a.LevafasCluke i) First i)Submitted renewal
Drench and Worm renewal due on 06-08-2011 with
Contains:- 18-07-2006 (Drench. on 17-07- late fee (Rs.8000)
Levamisole HCI Rep. of Ireland. 2011 was within the validity
B.P……………1. Last renewal NorbrookLaborat period of 60 days
submitted on
5% w/v application orries (Ireland) after expiry date of
Oxyclozanide B.P submission date Ltd.) 06-08-2011 renewal. Copy of
(Vet)………….3. 15-07-2016. with fee of challan form is
0% w/v Me-too Rs.8000/- attached for
Cobalt Levozan Plus reference.
Sulphate……0.38 Suspension
2% w/v M/s. Star ii) Form-5 is ii) Form 5 dully
(Composition as Laboratories signed and signed by the
per initial (Pvt) Ltd. submitted by contract
registration Lahore. giver/registration
M/s. Intervac
letter)
100ml acceptor.
500ml
1000ml iii) Finished iii) Finished
5000ml product product
not provided. provided.
iv) Latest iv) Latest
inspection inspection report
report of of M/s.
M/s. Intervac Intervac(Pvt) Ltd.
for Liquid For liquid section.
Section.
v) Master v) Master formula of

formula is Levopower Drench
not correct. provided.
4. -do- Levozide Solution 008038 a.Chanaverm i) As per i) Regarding
Contains:- Plus Oral Form-5 the change of brand
Levamisole HCI 27-02-1985 Solution firm has name, it is a
B.P. (Ireland. changed typographic
(Vet)………1.5% Already renewed Chanelle
brand name mistake. We feel
w/v upto 26-02-2015. Pharmaceuticals
Last renewal Manufacturing to Levozide sorry for that and
(Composition as application Ltd.) Worm again submitting
per submitted on 10- Drench 1.5% the Form-5.
Form-5) 02-2015. w/v (vet).
Me-too
100ml Nayverm 1.5% ii) Moreover, ii) Regarding
250ml W/V Oral the initial initial original
500ml Solution original registration letter
1 Litre M/s. Saymans registration does not contain
Pharmaceuticals letter (issued detail composition,
(Pvt) Ltd. in 1985) it is not practiced
Lahore. by the MOH that
does not
contain detail time.
composition.
iii) Form-5 is iii) Form 5 dully

acceptor.
iv) Latest iv) Latest

inspection inspection report
report of of M/s. Intervac
M/s. Intervac (Pvt) Ltd. For
for Liquid liquid section
Section. provided.
5. -do- Fendanid Plus 031478 a.N.A i) Form-5 is i) Form 5 dully
Liquid signed and signed by the
Contains:- 06-10-2003 Me-too submitted by contract
Oxfendazole..2.26 26-09-2008 Oxarex Gold M/s. Intervac giver/registration
5% w/v 03-10-2013 Drench
Oxyclozanide..6.2 M/s. Star
5% w/v Laboratories acceptor.
Selenium…….0.0 (Pvt) Ltd.,
ii) Latest ii) Latest
5% w/v Lahore,
Cobalt...0.167% inspection inspection report
w/v report of of M/s. Intervac
(Composition as M/s. Intervac (Pvt) Ltd. For
per initial for Liquid liquid section
registration letter) Section. provided.
100ml
250ml
500ml iii) Master iii) Master formula
1000ml
formula is of Fendanid Plus
5000ml not correct. Liquid provided.
6. -do- Sulphadin 000789 i) Initial i)Initial

Injection (Vet) registration registration
Each 100ml 01-07-1976 letter not certificate is not
contains:- Last renewal provided. available at this
Sulphadimidine application
time. We are
Sodium………… submission date
33.33gm 29-06-2016. submitting a copy
of “The Gazette of
(Composition as Pakistan, Extra
per dated October, 14,
Form-5) 1981”.
100ml ii) The ii) Regarding the

change of change of brand
brand name name letter does
letter (issued not contain details
in 2002) composition, it is
does not not practiced by
contain detail the MOH that
composition. time. For detail
However the composition we
composition are submitting a
can be copy of “The
confirmed Gazette of
from Pakistan, Extra
National dated October, 14,
Formulary of 1981”.
Pakistan.
iii) Form-5 is iii) Form 5 dully

acceptor.
The firm has provided following documents for this purpose:

i. Application on Form-5 with fee of Rs.50,000/- for each product.
ii. Copy of initial registration letters.
iii. Copy of last renewal status.
iv. Latest GMP inspection report of M/s. Intervac (Pvt) Ltd., 18 Km Lahore
Sheikhupura Road, Sheikhupura (dated 28.02.2017 & 17-03-2017). Having
evidence of section availability of M/s. Intervac (Pvt) Ltd., 18 Km Lahore
Sheikhupura Road, Sheikhupura.
v. Copy of DML M/s. P.D.H Laboratories (Pvt.) Ltd, 9.5KmSheikhupura Road,
Lahore & M/s. Intervac (Pvt) Ltd., 18 Km Lahore Sheikhupura Road,
Sheikhupura.
vi. Undertaking contract manufacturing through M/s. Intervac (Pvt) Ltd. for two and
half years for above mentioned drugs.
vii. Copy of contract manufacturing agreement b/w M/s. P.D.H Laboratories (Pvt.)
Ltd, 9.5KmSheikhupura Road, Lahore & M/s. Intervac (Pvt) Ltd., 18 Km Lahore
Sheikhupura Road, Sheikhupura. (dated 08-08-2017).
viii. Copy of CRF of M/s. Intervac (Pvt) Ltd. valid upto 31-12-2017.
Registration Board in its 279th meeting deferred M/s. P.D.H Laboratories (Pvt.) Ltd, 9.5
Km Sheikhupura Road, Lahore request for confirmation of status of renovation plan and
timelines of their oral and injectable veterinary sections from Licensing Division of DRAP.
Letter issued to Licensing Division for confirmation of status of renovation plan and
timelines of their oral and injectable veterinary section. In response Licensing Division has
informed that layout plan for following sections of M/s. PDH Laboratories (Pvt) Ltd, Lahore was
approved on 08-01-2019.
1. Tablet (Penicillin) Section (New).
2. Capsule (Penicillin) Section (New).
3. Dry Powder Suspension (Penicillin) Section (New).
4. Dry Powder Injection (Cephalosporin) (Revised).
5. Syrup (General) Section (New).
6. Capsule (General) Section (New).
7. Sachet (General) Section (New).
8. Tablet (General) Section (New).
9. Narcotics (General) (Human) (Revised).
10. Drench (General) (Veterinary) Section (Revised).
11. Injectable (Vial) (General) (Veterinary) Section (Revised).
Case No. 10:- Request of M/s. Leads Pharma (Pvt) Ltd., Islamabad for Correction of Pack
Sizes.
Registration Board in its 277th meeting approved following locally manufactured

veterinary drug of M/s. Leads Pharma (Pvt) Ltd., 81-A, Street # 6, I-10/3, Islamabad.
S.No Name of Name of drug(s) & Approved Remarks

Manufacturer Composition Packs
Sizes
1. M/s. Leads Levacare Bolus 600mg 100ml Approved
Pharma (Pvt) Each Bolus contains:- 200ml USP specifications
Ltd., 81-A, LevamisoleHCl……600mg 500ml
Street # 6, 1 Litre
I-10/3,
Islamabad.
Further processing of the registration letter of above mentioned product was withheld as
the product is in Bolus form while the pack sizes demanded by the firm were mentioned as
100ml, 200ml, 500ml& 1Litre.The firm has now provided revised Form-5 wherein the demanded
pack sizes are mentioned as 5 Bolus, 50 Bolus & 100 Bolus. Firm has deposited fee of Rs.5000/-
along with revised Form-5.
Case No. 11:- Registration of Product Lincomycin-40S Oral Powder in favor of M/s.
Orient Traders International, Karachi.
The Registration Board in its 277th meeting considered request of M/s. Orient Traders
International, Karachi regarding change of registration status of following veterinary products
from M/s. Orient Animal Health (Pvt) Ltd, Karachi to M/s. Orient Traders International,
Karachialong with change of manufacturer.
S. Name of Drug(s) Pack Sizes (as Previous Decision of Reg. Board in 277th
No. Composition as per mentioned in Manufacture Meeting
CoPP 236th Meeting) r
1. Lincomycin-40S Oral 100gm M/s. Manufacturer:

Powder 500gm V.M.D.N.V M/s. Biove, 3 Rue de Lorraine,
Each gm contains:- 1Kg Hoge Mauw
Lincomycin 10Kg Arendonk
62510 Arques, France.
hydrochloride equivalent 25Kg Belgium. (manufacturer of the finished
to product, Packager, Labeling,
Lincomycin…..400mg/g QC)
Labeling & Batch Release:
M/s. V.M.D. n.v. Hoge, Mauw
900,2370, Arendonk, Belgium.
Product License Holder:
M/s. V.M.D. n.v. HogeMauw
900, 2370, Arendonk,
Belgium.
Later, the firm has provided new valid legalized CoPP (issued by Belgium Authority)
along with revised Form-5A (and fee of Rs.5000/-) wherein the details of manufacturer/product
license holder is mentioned as;
Manufacturer
M/s. Laboratoires Biove, 3 Rue de Lorraine, 62510 Arques, France.
(Manufacturer of the finished product, Packager, Labeling, QC).
Producct License Holder:-

M/s. V.M.D. n.v.
Hauw 900, 2370, Belgium.
Registration letter for the said product has been issued with name and address of
manufacturer and product license holder in accordance with details pesent in new CoPP.
Submitted for information of Registration Board.
Case No.12:- CANCELLATION OF REGISTRATION OF OXYTOCIN MULTI-DOSE

VIALS IN VETERINARY.
The Registration Board in its 278th meeting held on 29-31st January, 2018 while
considering their agenda item viz “Manufacture & Sale of Adulterated & Sub-Standard
“Oxytocin Injection (for vet only)”, interalia, decided as under:-
“Registration Board advised PE&R Division to present case regarding
alleged use of Oxytocin multi-dose vials for enhancement of milk production
in the animals.”
The Board agreed to issue show cause notice of multi-dose vials on the same lines which
have been adopted by India. They allow only one mL Oxytocin ampoule for human use only.
Later, Registration Board in its 286th meeting was informed that show cause notices have been
issued to following 25 firms having registration of Oxytocin Multi-dose vials.
S. No. Name of Firm’s

1. M/s. Elko Organization (Pvt.) Ltd, Karachi.
2. M/s. International Pharma Labs. Lahore.
3. M/s. Intervac (Pvt) Ltd., Sheikhupura.
4. M/s. BiogenPharma,Chakbeli Road, Rawat.
5. M/s. Epoch Pharmaceuticals, Karachi.
6. M/s. Zakfas Pharmaceuticals Pvt Ltd., Multan.
7. M/s. Tabros Pharma (Pvt) Ltd., Karachi.
8. M/s. Dosaco Laboratories, Lahore.
9. M/s. Geofman Pharmaceuticals, Karachi.
10. M/s. Vetcon Pharmaceuticals Pte. Ltd., Azad Kashmir.
11. M/s. Venus Pharma, Lahore.
12. M/s. Imran & Company, Karachi.
13. M/s. ISIS Pharmaceuticals & Chemical Works,
(Formerly M/s. Krka-Pak Pharmaceutical), Karachi.
14. M/s. Kakasian Pharmaceuticals (Pvt) Ltd., Lahore.
15. M/s. Amrose Pharmaceuticals, Karachi.
16. M/s. LawarlancePharma, Lahore.
17. M/s. S.J & G FazulEllahie (Pvt.) Ltd, Karachi.
18. M/s. Sanna Laboratories, Faisalabad.

19. M/s. Biorex Pharmaceuticals, Islamabad.
20. M/s. Rex Pharmaceuticals, Karachi.
21. M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura.
22. M/s. Jfrin Pharmaceutical Laboratories, Balochistan.
23. M/s. Manhattan Pharma, Karachi
S. No. Name of Firm’s
24. M/s. Alina Combine Pakistan (Pvt) Ltd., Karachi.
25. M/s. Eros Pharmaceuticals (Private) Limited, Karachi.
So far reply from 11 firms have been received wherein they have responded with their
point of view including request for personal hearings.
The salient points, of the responses received are summarized as under:-
i) Oxytocin Injection is not used for the enhancement of milk product in dairy
animal. Oxytocin is a pituitary hormone that has very short span of effectiveness -
it is absorbed immediately after natural release or injection it lasts around three
minutes in the bloodstream of a healthy animal before it is completely absorbed
and metabolized.
ii) Oxytocin is used as uterine contractor to precipitate and accelerate normal
parturition and postpartum evacuation of uterine debris. In surgery it may be used
postoperatively following cesarean section to facilitate involution and resistance
to the large inflow of blood. It contract smooth muscle cells of the mammary
gland for milk letdown if the udder is in proper physiological state.
iii) Oxytocin is not intended for milk enhancement but to facilitate milking letdown
process and to maximize the efficient removal of milk. Oxytocin is used to
letdown the milk worldwide.
iv) A firm has requested for providing the necessary record.
v) Instead of cancelling the registration and manufacturing of this product, its misuse
be stopped by regulating prescription and sales.
vi) A number of firms have requested chance to be heard in person.
Post Registration-I
Case No. 01. Manufacturing Site transfer of currently toll manufacturing products from M/s Akhai
Pharma, Karachi to GSK 35-Dockyard Road, West Wharf, Karachi.
Previous Case History(M-287):

“Termination of Contract Manufacturing and Registration of Drugs For Manufacturing on their
Own Facility.
M/s GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi has intimated that
they intend to terminate the contract manufacturing from M/s Akhai Pharma, Karachi under DRA
permission letter dated 15th October, 2015 due to some capacity constraints. As a part their future
manufacturing and Supply plan, they have now increased the Manufacturing Capacity of West
Whraf site to commence production of allthese product in-house. This arrangement will also
contribute to ensure long term supply sustainability of these products in local market. The details of
the products are as under:
Sr.# Reg. No. Name of drug(s). International Availability
1. 019464 Brevoxyl Cream Approved by MHRA, UK
Each gm contains: Brevoxyl 4 % Cream by GSK Consumer
Benzoyl peroxide…………...4 % Healthcare
2. 043657 Clinagel Approved by US FDA,
Each gm contains: CLINDAGEL 1 % by Precision Dermat
Clindamycin phosphate…...10mg
3. 019738 Lacticare 1% Lotion Approved by US FDA,
Each gm contains: ACTICORT 1 % Lotion by Baker
Hydrocortisone…………....1.06% Norton (Marketing status Discontinued)
4. 019739 Lacticare 2.5% Lotion US FDA,
Each gm contains: ALA-SCALP 2 % Lotion by Crown
Hydrocortisone………….…2.5% Labs
5. 005039 Lacticare Lotion Evidence of approval in Reference
Each gm contains: regulatory authorities required from the
Sodium pyrrolidone firm
Carboxylate……………....2.75%
Lactic acid………………..5.70%
6. 024757 Stiemazole Lotion MHRA, UK
Each gm contains: Canestene 1 % w/v Solution by Byer plc
Clotrimazole………….……..1%
7. 048074 Stieproxal Liquid Evidence of approval in Reference
Each gm contains: regulatory authorities required from the
Ciclopiroxolamine…………15mg firm.
Salicylic acid………………30mg
8. 026392 Stieprox Liquid Health Canada
Each gm contains: (Stieprox Shampoo (cicolpirox olamine
Cyclopirox Olamine….…….1.5% 1.5%).
Details of M-274:
Above products were considered and approved by the Registration Board in its 250th meeting on
contract manufacturing basis from M/s Akhai Pharma, Karachi vide letter No.F. 3-4/2015-Reg-II-
(M-250), dated 15.10.2015 valid up to 30.06.2020.
Decision of M-274:
Registration Board was apprised that M/s GlaxoSmithKline Pakistan Limited,
35-Dockyard Road, West Wharf, Karachi has now withdrawn their request for
termination of contract manufacturing of the above mentioned products, which
was acceded accordingly.
Details of M-287:
Then, the firm has requested for reconsideration of above request for transfer of registration of the subject
products to their name with documents submitted previously.
Decision of M-287: Registration Board deferred the case for submission of fresh application along
with requisite fee for each product.”
Detail of Current Submission:
Now the firm has submitted following documents/ details transfer of currently toll manufacturing
products from M/s Akhai Pharma, Karachi to their own site, i.e., GSK 35-Dockyard Road, West Wharf,
Karachi.:-
i. Fresh application on form-5 with its enclosures and 20,000/- fee for each product.
ii. Copy of Registration certificates and last renewal status.
iii. Section approval.
iv. Copy of last inspection report.
v. Undertaking that the applicant do not have registration of same products.
vi. Undertaking that the firm will conduct real time stability data.
vii. Undertaking that the firm will submit the validated method of analysis, master formula
& product development data.
viii. Undertaking that in case of any quality complaint/OOS result observed as a result of
change, same shall be reported to registration board immediately.
ix. Undertake that the provided information is true & correct.
Submitted for consideration of Registration Board please.

Case No.02. Change of Brand Name of Products of M/s. High-Q Pharmaceuticals Karachi.
M/s. High-Q Pharmaceuticals, B-64,KDA-1, Karachi Road, Karachi has requested for change of brand
name of their following registered products. The details are as under:-
Sr. Regn. Existing Name Proposed Initial Justification Remarks
# No. Name registration
with renewal
I II III IV V VI VII
1. 076201 Velker Plus Tablet Co-Velker Date of They want to Dy # 36921
Each film coated registration interchange the brand Date07-11-18
tablet contains:- 29-01-2014. name with their other
Valsartan ….. 160mg brand name Co-Velker
Hydrochlorthiazide to avoid confusion in the
………………. 25mg market.
2. 076205 Co-Velker Tablet Velker -do- They want to Dy # 36917
Each film coated Plus interchange the brand Date 07-11-18
tablet contains:- name with their other
Amlodipine as brand name Velker Plus
besylate ….…. 10mg to avoid confusion in the
Valsartan……160mg market.
3. 076207 Velker Plus Tablet Co-Velker -do- They want to Dy # 36920
Each film coated interchange the brand Date 07-11-18
……………. 12.5mg market.
Each film coated Plus interchange the brand Date 07-11-18
besylate ……...5mg to avoid confusion in the
Valsartan … 160mg market.
5. 076210 Velker Plus Tablet Co-Velker -do- They want to Dy # 36922
Each film coated interchange the brand Date 07-11-18
……………. 12.5mg market.
Each film coated Plus interchange the brand Date07-11-18
besylate …. …...5mg to avoid confusion in the
Valsartan …… 80mg market.
The firm has submitted following has submitted following documents:
Sr.# Required documents Submitted documents
a. Application with required fee as per relevant SRO (in case of similarity / Deposited fee of
resemblance with already registered drug, fee will not be required) Rs.20,000/-
b. Copy of registration letters & and renewal status Copy of registration
letter is not provided.
c. Justification for proposed change. Stated as above
d. Information regarding previous change of brand name since registration of drug. Provided
e. Details (batch number, date of manufacture, quantity and stock position) Provided.
regarding last batch manufactured
f. An undertaking that the proposed names do not resemble with already Provided
registered brands. In case of resemblance/similarity with already registered
drug, the applicant will be liable to change immediately. Moreover, no case is
pending at any forum / court of law regarding this matter.
The Post Registration Variation Committee, in its 19th meeting, referred the case to Registration Board.
Decision of M-287:
Registration Board deferred the case & directed the firm to submit rational
justification regarding change in brand name.”

Now the firm has given justification that the brand names of other firms already using the
brand names for their products with same combination in the country. Furthermore we
have duly deposited the required fees. It is also to mention here that to date we have
neither manufactured nor market these products.
 Submitted for consideration of Registration Board please.
Case No.03 Change of address of manufacturing site of their registered imported product i.e.
Omega Infusion (M/s. Ferozsons Laboratories Ltd., Nowshera).
M/s Ferozsons Laboratories Ltd, Nowshera, has informed that the principal manufacturer
Changzhou Siyao Pharmaceuticals Co, Ltd China of their registered product i.e., Omgea Infusion
(Omperazole), registration number 029023, registration date 02-12-2002, has changed its
manufacturing site abroad i.e. From: Meilongba, Southern Suburbs, Changzhou, Jiangsu, China To
No.567 Zhongwu Avenue, Changzhou, Jiangsu-China.
Firm has submitted following documents:
 Form 5-A.
 Original deposit slip of fee Rs.5000/- (Bank Receipt No.0788874 dated. 22-10-2018.)
 Copy of registration letter and last renewal status.
 Certificate of Pharmaceutical Product.
 Original and legalized GMP certificate.
 Summary drug information.
 Original Free Sale Certificate.
 Site master file of new manufacturing site.
 Undertaking that the provided information / documents are true / correct.
Decision of 22nd meeting of PRVC: -
The chairman in the light of the recommendations made by the committee decided to refer the
above mentioned case for next Registration Board.”

Now the firm has submitted the differential fee Rs. 95,000/- dated 08-02-2019.
 Submitted for consideration of Registration Board please.
Case No. 04 Request for Post Registration Variations in Registered Product of M/s
Martin Dow Limited, Karachi.
M/s Martin Dow Limited, Karachi has requested for following post registration
variations w.r.t Xenical Capsule 120mg (042142), registered in the name of M/s Martin Dow
Pharmaceuticals Limited, Karachi:
1. Change in name/ title of importer from M/s Martin Dow Pharmaceuticals Limited,
Karachi to M/s Martin Dow Limited, Karachi (Manufacturing site remains the same).
2. Change in name of manufacturer from M/s Roche S.p.A. Milan, Segrate, Italy to M/s
Delpharm Milano S.R.L. via Carnevale 1, 20090 Segrate (MI), Italy (As per CoPP site is
also responsible for quality control, primary & secondary packaging).
3. Change in license holder from F. Hoffmann La Roche Ltd, Basel, Switzerland to
Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald-Germany.
Sr. Reg. No. Product Name &Composition Date of application
No. with Dy. No. and fee
1 042142 Xenical Capsule 120mg 10-12-2018
Each capsule contains: Dy. 2506
Orlistat…………………….…120mg Rs.100,000/-
Detail of documents submitted by the firm:
a) Application on Form-5 with fee of Rs.100,000/-
b) Copy of registration letter (Issued date 22.12.2010) and last renewal status (Submitted on
22.06.2015).
c) Approval of new name / title from CLB.
d) Undertaking that:
i. The formulation, API source & Specifications, manufacturing process, release & shelf life
specifications have not changed.
ii. Provided information is true & correct.
e) Original and legalized Certificate of Pharmaceutical Product of Xenical Capsule (Certificate No.
04/18/122120, certified by EMA) indicating free sale in exporting country.
f) Original and legalized transfer agreement between Roche Switzerland and Cheplapharm-
Arzneimittel GmbH-Germany.
g) Original and legalized copy of GMP certificate of Delpharm Milano S.R.L Italy.
h) Original and legalized copy of manufacturing License of Delpharm Milano S.R.L Italy (with English
translation).
i) Revised Sole Agency Agreement between Cheplapharm-Arzneimittel GmbH-Germany and M/s
Martin Dow Limited, Karachi dated 12-09-2018.
j) Agreement between Cheplapharm-Arzneimittel GmbH-Germany and Delpharm Milano S.R.L.
k) Proof/ evidence of the contract between Product License Holder & manufacturer (with
changed/ new name), where the manufacturer and product license holder are different entities.
The case is submitted for consideration of the Board.
Case No. 05: Application for change of toll manufacturing of drug for local manufacturing
namely Esorok 40mg injection, pack size : 1’s
M/s Rakaposhi pharmaceutical (Pvt) Ltd. Peshawar, hereby apply for change of
toll manufacturing for local manufacturing of our drug Esorok 40mg injection from M/s
weather folds Pharmaceuticals, 69/2, phase-II, industrial estate, Hattar to M/s mediate
pharmaceutical (Pvt) Ltd, 150-151, sector 24, Korangi Industrial area, Karachi.
Detail of documents submitted by the firm:
a). Application on Form-5 and Bank deposited slip number 0766246 dated 04.02.2019 for
Rs.50,000/-(Fifty thousand only)
b). Registration letter of Esorok 40mg is attached (issued date 16.02.2018)
c). Agreement between M/s Rakaposhi pharmaceutical (Pvt) Ltd. Peshawar and M/s Mediate
Pharmaceutica (Pvt) Ltd. 150-151, sector 24, Korangi Industrial area, Karachi.
d). Copy of DML and relevant section approval of M/s M/s mediate pharmaceutical (Pvt)
Ltd, 150-151, sector 24, Korangi Industrial area, Karachi from Licensing Division.
e). Firm also submitted Undertaking statements as per SOP.
f). GMP inspection report conducted on 20.07.2018 with satisfactory level of compliance.
Post Registration-II
Case No. 1: Transfer of registered products from previous site (I-10/3) to new site
(National Industrial Zone, Chamber Industrial Area, Rawat, Rawalpindi) of M/s. Benson
Pharmaceuticals:
M/s Benson Pharmaceuticals, Islamabad have requested for transfer of registration of

below mentioned products form their previous site i.e. Plot No. 119, Street No.8, I-10/3,
Islamabad to new site Plot No. 3, Main Road, National Industrial Zone (Chamber Industrial
Area) Rawat, Rawalpindi as per detailed below:-
Reg. Initial
S. Product for Registration with Renewal
No. registration Remarks
No. Generic Name Status
date
1. Benprol 40mg capsules
Each capsule contains:- 01-10-
Esomeprazole Magnesium 2015
066247 12-10-2010
Trihydrate equivalent to 23-11-
Esomeprazole………. 40mg 2016
(Benson specs.)
2. Capzol 40mg capsules
Each capsule contains:-
15-02-
Omeprazole enteric coated 069867 06-04-2011
2016
(pellets)…………… 40mg
3. Alerfree tablets
08-05-
Each tablet contains: 024686 05-06-2002
2017
Loratadine …………….10mg
4. Benalox 250mg tablets
contains:- 26-10-
066560 08-11-2010
Levofloxacin (as 2015
hemihydrate)………….250mg
(BP Specs.)
5. Benalox 500mg tablets
contains:- 26-10-
066561 08-11-2010
Levofloxacin (as hemihydrate) 2015
………….…………500mg
(BP Specs.)
6. Benicef capsules 250mg
22-03-
Each capsule contains:- 030458 11-06-2003
2018
Cephradine …………250mg
7. Benicef capsules 500mg
22-03-
Each capsule contains:- 030459 11-06-2003
2018
Cephradine ……….500mg
8. Benicef suspension 125mg
22-03-
Each 5ml contains:- 030460 11-06-2003
2018
Cephradine ………..125mg
9. Benicef suspension 250mg 030461 11-06-2003 22-03-
Each 5ml contains:- 2018
Cephradine
………………..250mg/5ml
10. Benifime capsules
001288- 19-06-
Each capsule contains:- 11-08-2009
EX 2014
Cefixime ………….400mg
11. Benifime suspension
001289- 19-06-
EX 2014
Cefixime …………100mg
12. Benifix DS Suspens|ion
Each 5ml contains:-
30-05-
Cefixime Trihydrate eq. to 079512 01-06-2015
2020
Cefixime………….…200mg
(USP Specs.)
13. Benifix suspension
22-03-
Each 5ml contains:- 030463 11-06-2003
2018
Cefixime ……………100mg
14. Benkast 4mg sachet
Each Sachet contains:- 22-10-
091655 23-10-2018
Montelukast as 2023
sodium…………4mg
15. Benmether 40/240mg tablets
Each tablet contains:-
26-03-
Artemether………….. 40mg 077780 27-03-2014
2019
Lumefantrine ……….240mg
(USP Salmous Specs.)
16. Benmether 80/480mg tablets
26-03-
Artemether……….. 80mg 077781 27-03-2014
2019
Lumefantrine ……..480mg
(USP Salmous Specs.)
17. Benmox tablets
30-05-
Moxifloxacin HCl eq. to 079513 01-06-2015
2020
Moxifloxacin ……... 400mg
(Benson Specification)
18. Benmycin 250mg capsule
18-02-
Azithromycin as 087387 19-02-2018
2023
dehydrate………….. 250mg
(USP Specification)
19. Benprofen tablet 100mg
Each tablet contains:- 11-11-
062331 22-12-2009
Flurbiprofen……….. 100mg 2014
20. Benprol 20mg capsules Source india to
Each capsule contains:- 01-10- local M/s. Vision
Esomeprazole Magnesium 2015 Pharmaceuticals,
066246 12-10-2010
Trihydrate equivalent to 23-11- Islamabad.
esomeprazole ………….20mg 2016
(Benson Specs.)
21. Benroxim suspension 125mg
Each 5ml contains:-
03-04-
Cefuroxime (as 056790 20-05-2009
2014
Axetil)………………125mg
(USP Specification)
22. Bentoril 25mg tablets
22-03-
Each tablet contains: 021571 02-05-1998
2018
Captopril………… 25mg
23. Bentos-f chewable tablet
22-12-2009
Brand name
Iron (III) hydroxide Polymaltos
change 05-11-
complex equivalent to 062334
(Ihpoc) 2014
elemental iron………..100mg
31-12-2010
Folic Acid………….. 0.35mg
(Benson Specification)
24. Bepsin tablets
021569 02-05-1998
Famotidine ……………20mg 2018
25. Bepsin tablets 40mg

22-03-
Each tablet contains:- 021570 02-05-1998
2018
Famotidine……………. 40mg
26. Capzol 20mg capsules 06-04- Source India to
Each capsule contains:- 2021 local M/s. Vision
Omeprazole enteric coated (RRR Pharmaceuticals,
069866 06-04-2011
(Pellets)…………….. 20mg Letter Islamabad
(USP Specs.) dated 24-
01-2017)
27. Cardi 50mg tablets
22-03-
2018
Atenolol…………….. 50mg
28. Domotin tablets
22-03-
2018
Domperidone ……….10mg
29. Fluoxoben 12/25mg capsule
Olanzapine 12mg+ fluoxetine 87388
as hydrochloride 25mg
30. Fobin 250mg tablets
26-10-
Ciprofloxacin as 066562 08-11-2010
2015
HCl…………….. 250mg
(USP Specs.)
31. Fobin 500mg tablets
066563 08-11-2010
Ciprofloxacin as HCl… 500mg 2015
(USP Specs.)
32. Gaboben 150mg capsule
18-02-
Pregabalin ……………150mg 087384 19-02-2018
2023
(As per *Innovator’s
Specifications)
33. Gaboben 75mg capsule
18-02-
Pregabalin…………75mg 087385 19-02-2018
2023
(As per *Innovator
Specification)
34. Keygesic 75mg tablet
27-03-
2018
Diclofenac potassium… 75mg
35. Keygesic tablet
27-03-
2018
Diclofenac Potassium….. 50mg
36. Lovin tablets
Each tablet contains: 29-10-
022541 26-11-1998
Clomiphene 2018
Citrate…………… 50mg
37. Mebenzadole tablet
16-12-
2014
Mebendazole …………100mg
38. Piclo 20mg tablet
contains:- 30-05-
079514 01-06-2015
Piroxicam beta cyclodextrin = 2020
cyclodextrin ………20mg
(Benson specificaion)
39. Tamsuben 0.4mg capsule
Tamsulosin (as hydrochloride) 24-04-
088463 25-04-2018
sustained release pellets eq. To 2023
tamsulosin ………….0.4mg
(USP Specification)
40. Zithben 250mg tablets
17-12-
Azithromycin as dihydrate 086129 18-12-2017
2022
………………….250mg
(USP Specs.)
41. Zithben 500mg tablets
17-12-
Azithromycin as dehydrate 086130 18-12-2017
2022
………………. 500mg
42. Foliron tablet
024905 15-07-1999
Ferrous Fumarate…..150mg 2014
Folic Acid…………..0.5mg
43. Bencetamol tablets 500mg
12-08-
2014
Paracetamol………….500mg
The firm have provided following documents in support of their request as per approved
SOP:
a) Application with form 5 and requirement fee amounting to Rs.100,000/- sr. no. 1 & 2.
b) Application with form 5 and requirement fee amounting to Rs.20,000/-.
c) Copy of registration letter and renewal.
d) Evidence of Section as revealed by the GMP certificate (Tablet General, Capsule General,
General Sachet powder, Dry Powder Suspension (Cephalosproin), Capsule Section
(Cephalosproin)
e) DML of new site issued on 08-01-2019.
f) Copy of last inspection report: N/A as it is a new manufacturing facility.
Case No.2: Change in Contract Manufacturer:
M/s. Caliph Pharmaceuticals (Pvt) Limited, Risalpur, KPK have requested for
change in contract manufacturer from M/s Bio-Labs (Pvt) Limited, Islamabad to M/s Nicholas
Pharmaceuticals, Rawat, Islamabad for the following registered products. Their previous
approval was granted by the Registration Board in its 271st meeting dated 10th November, 2017
valid for five years from the date of issuance as per detailed below:-
S. Name of Existing New Reg. Name of drug(s) & Date of Initial
N Applicant Manufactu Manufactur No. Composition applicati registrati
o. rer er on, on date
Diary and
No. & validity
Form
1. M/s. Caliph M/s. Bio- M/s. 0825 Grancef Dry 12-10- 10-11-
Pharmaceuti Labs (Pvt) Nicholas 60 Suspension 2018 2017
cals, Plot no. Limited, Pharmaceuti 100mg/5ml Dy.No.81 valid for
17, Special Plot # 145, cals, Plot Each 5ml contains:- DDC five
Industrial Industrial No. 34, Cefixime (as Reg-IV years
Zone, triangle, street no. SS- trihydrate)…..100mg Rs.50,00 from the
Raisalpur, Kahuta 2, National (USP Specifications) 0/= date of
KPK Road, Industrial issuance
Islamabad Zone, Rawat
Islamabad
2. -do- -do- -do- 0825 Grancef Dry 15-10- 10-11-

61 Suspension 2018 2017
200mg/5ml Dy.No.82 valid for
Each 5ml contains:- DDC five
Cefixime (as Reg-IV years
trihydrate)…..200mg Rs.50,00 from the
(USP Specifications) 0/= date of
issuance
3. -do- -do- -do- 0825 Unixone injection 1g 15-10- 13-10-
55 IV 2018 2017
Each vial contains:- Dy. #80 valid for
Ceftriaxone Sodium DDC five
Equivalent to Reg-IV years
Ceftriaxone …..1gm Rs. from the
(USP Specifications) 50,000/- date of
issuance
4. -do- -do- -do- 0825 Unixone injection 15-10- 13-10-
56 250mg IM 2018 2017
Ceftriaxone Rs. from the
……………..250mg 50,000/- date of
(USP Specifications) issuance
5. -do- -do- -do- 0825 Unixone injection 15-10- 13-10-
57 500mg IM 2018 2017
Ceftriaxone from the
Rs.
…………….500mg date of
(USP Specifications) 50,000/- issuance
6. -do- -do- -do- 0859 Grancef Capsule 15-10- 27-11-
19 400mg 2018 2017
Each Capsule Dy. #83 valid for
contains:- DDC five
Cefixime (as Reg-IV years
trihydrate)……..….. Rs. from the
400mg 50,000/- date of
(JP Specifications) issuance
Firm has submitted following documents in this regard:
a) Application/Form 5 along with fee of Rs.50,000/- for each product.

b) Copy of contract manufacturing agreement between M/s. Caliph Pharmaceuticals, Risalpur
and M/s. Nicholas Pharmaceuticals, Islamabad dated 24-09-2018.
c) Panel GMP inspection report of M/s Nicholas Pharmaceuticals, Islamabad (dated 03-08-
2018) concluding that panel unanimously recommended grant of DML.
d) DML of both contract giver (06-11-2018) and acceptor (29-08-2018).
e) Copy of letter for Approval of Cephalosporin (Capsule) section (M/s Nicholas
Pharmaceuticals, Rawat, Islamabad).
Case No. 3: Change in specifications (M/s. Aurik Pharmaceuticals, Islamabad)
M/s. Aurik Pharmaceuticals, Islamabad have requested for change in finished

product specification of their following registered products as per details below:-
S.No. Reg.No. Name of drug(s), Composition and Name of drug(s), Composition with
Specifications desired Specifications
1. 078051 Aurofloc tablet 250mg Aurofloc tablet 250mg
Each film coated tablet contains:- Each film coated tablet contains:-
Levoflocacin Hemihydrate eq. to Levoflocacin Hemihydrate eq. to
Levofloxacin………….250mg Levofloxacin………….250mg
(Aurik Specifications) (USP Specifications)
2. 078052 Aurofloc tablet 500mg Aurofloc tablet 500mg

Levoflocacin Hemihydrate eq. to Levoflocacin Hemihydrate eq. to
Levofloxacin………….500mg Levofloxacin………….500mg
3. 078054 Cipaur tablet 500mg Cipaur tablet 500mg
Ciprofloxacin Hydrochloride eq. to Ciprofloxacin Hydrochloride eq. to
Ciprofloxacin …………500mg Ciprofloxacin …………500mg
(BP Specifications) (USP Specifications)
4 078048 Airon tablet 10mg Airon tablet 10mg
Montelukast sodium eq. to Montelukast Montelukast sodium eq. to Montelukast
………….10mg ………….10mg
5. 078053 Moxrik tablet 400mg Moxrik tablet 400mg
Each tablet contains:- Each tablet contains:-
Moxifloxacin ………………..400mg Moxifloxacin HCl eq. to. Moxifloxacin
(Aurik Specifications) ………………..400mg
6 078055 Pext Tab 20mg tablet Pext Tab 20mg tablet
Paroxetine (as hydrochloride)…….20mg Paroxetine (as hydrochloride)…….20mg
(BP Specifications) (USP Specifications)
7 080545 Pext-CR 12.5mg tablet Pext-CR 12.5mg tablet
Each SR tablet contains:- Each SR tablet contains:-
Paroxetine hydrochloride eq. to Paroxetine hydrochloride eq. to
Paroxetine…………………...12.5mg Paroxetine…………………...12.5mg
(Manufacturer’s Specifications) (USP Specifications)
The details of requirement as per SOPs and the documents submitted by the firm are as under:-
Requirement as per SOPs Documents submitted by the Firm.

Application with required fee as per relevant SRO. Fee of Rs.5000/- deposited for each product dated
If error is on part of firm. 30-01-2019
Copy of registration letter and renewal status. Initial Registration: 05-11-2014 (at Sr. No. 1-4)
Renewal due: 04-11-2019
Renewal is Ok
Initial Registration: 13-09-2018 (at Sr. No. 5)

Renewal is Ok.

Renewal is Ok.

Renewal is Ok.
Documents in support of proposed correction The firm has provided copy of USP monograph for
product. The product at Sr. No. 5 is approved by
USFDA as film coated tablet.
Now, the firm has requested for approval of finished product specifications of above product
to “USP”.
The firm has submitted an undertaking that:-

i. The change is made exclusively to comply with the pharmacopeia of RRA or as per
innovator product specifications.
ii. No case is pending at any forum/court of law regarding this product.
iii. In case of any quality complain/OOS result of observed by the marketing authorization
holder as a result of this change, the same shall be reported to Registration Board and all
the stock shall be recalled from the market immediately.
iv. The provided information/documents are true and correct.
The case submitted for consideration of Registration Board.
Case No. 04 Change in specifications (M/s. Fynk Pharmaceuticals, Lahore)
M/s. Fynk Pharmaceuticals, Lahore have requested for change in finished product
specification of their following registered products as per details below:-
1. 038512 Lurk 250mg tablet Lurk 250mg tablet
Each tablet contains:- Each film coated tablet contains:-
Levofloxacin (as Hemihydrate)….250mg Levofloxacin (as Hemihydrate)….250mg
2 038513 Lurk 500mg tablet Lurk 500mg tablet
Each tablet contains:- Each film coated tablet contains:-
Levofloxacin (as Hemihydrate)….500mg Levofloxacin (as Hemihydrate)….500mg

Application with required fee as per relevant SRO. Fee of Rs.5000/- deposited for each product dated
Copy of registration letter and renewal status. Initial Registration: 27-05-2005
Renewal valid till 26-05-2020 vide letter no. 2-
1/2017 RRR (M-264) dated 28-04-2017
Renewal is Ok
product. The product is approved by MHRA as film
coated tablet.
to “USP”.
The firm has not submitted an undertaking that:-

Case No. 05: Change in specifications (M/s. Focus & Rulz Pharmaceuticals, Islamabad)
M/s. Focus & Rulz Pharmaceuticals (Pvt.) Limited, Islamabad have requested for
change in finished product specification of their following registered products as per details
below:-
1. 011003 Ulfam tablet 20mg Ulfam tablet 20mg
Famotidine…………….20mg Famotidine…………….20mg
2. 011004 Ulfam tablet 40mg Ulfam tablet 40mg
Famotidine…………….40mg Famotidine…………….40mg

Application with required fee as per relevant SRO. Fee of Rs.5000/- for each product, deposited dated
Renewal applied: 16-09-2014
Renewal is Ok.
product.
to “USP”.

The case submitted for consideration of Registration Board
Case No. 06: Change in specifications (M/s. Innvotek Pharmaceuticals, Islamabad)
M/s. Innvotek Pharmaceuticals, Islamabad have requested for change in finished

product specification of their following registered products as per details below:-
1. 094169 Delot tablet 5mg Delot tablet 5mg
Desloratadine……………..5mg Desloratadine……………..5mg
(As per *innovator’s Specification) (USP Specification)

Application with required fee as per relevant SRO. Fee of Rs.5000/- deposited dated 16-01-2019
If error is on part of firm.
Renewal is Ok.
product.
to “USP”.

The case submitted for consideration of Registration Board
Case No.07 Grant of Registration of M/s. Bayer Pakistan (Pvt) Ltd, Lahore (Formerly
M/s. Medipharm (Pvt) Ltd, Lahore at New Manufacturer Title .
M/s. Bayer Pakistan (Pvt) Ltd, Lahore (Formerly M/s. Medipharm (Pvt) Ltd, Lahore) has
requested for grant of registration of below mentioned product at new manufacturer title i.e. M/s.
Bayer Pakistan (Pvt.) Ltd, Lahore as per detailed below:-
Sr No. Reg No. Name of Product and composition Remarks

1. 019520 Microgynon ED Fe tablet
Each coated tablet contains:-
Levonorgestrel Micro 20 = 0.150mg
Ethinyl estradiol Micro 20 = 0.030mg
Each placebo sugar coated tablet
contains:-
Ferrous fumarate = 75.000mg
The firm has submitted following documents.

i. Application with fee of Rs.100,000/- Form-5.
ii. Copy of Registration letters with renewal status.
iii. Copy of new title of firm from CLB.
iv. M/s. Medipharm (Pvt) Limited, Change of Brand Name product Nova
tablet to “Microgynon ED Fe” vide Letter No. 5-110/2013 Reg.-V dated
09-11-2016.
Referred Cases of 22nd PRVC
Case No 01: Change in specifications of M/s. Winlet Pharmaceuticals, Sargodha
Dy. No. 68 R-III dated 14-01-2019
M/s. Winlet Pharmaceuticals, Sargodha have requested (page 388/C) for change in
specifications of their following registered product with details below:-
Reg. Name of drug(s) with formulation Desired specifications

No.
1. 092038 Rocxi Tablet 20mg Rocxi Tablet 20mg
Piroxicam as (beta- Piroxicam as (beta-
cyclodextrin)………………20mg cyclodextrin)………………20mg
(USP Specification) (As per Innovator’s Specification)
The details of requirements as per SOP’s and the documents submitted by the firm are as
under:-

Application with required fee as per relevant Fee Rs.5000/- dated 02-01-2019
SRO. If error is on part of firm. (Pages 388-389/C)
Copy of registration letter and renewal status. Copy of Registration letter dated 08-10-2018
(Page 393-398/C)
Last renewal due: 07-10-2023

Renewal is not required
Documents in support of proposed correction The product is not available in any
pharmacopoeia. Firm has applied with
manufacturer’s specifications but approved
with USP specifications in 282nd meeting of
RB.
Decision:-
The Committee referred the case to Registration Board.

Case No 02: Change in specifications of M/s. Quaper Pharmaceuticals, Sargodha
Dy. No. 1076 R-III dated 04-12-2018
M/s. Quaper Pharmaceuticals, Sargodha have requested (page 311/C) for change in
specifications of their following registered product with details below:
S. Reg. Name of drug(s) with formulation Desired specifications

No. No.
1. 048927 Quvin 250mg Quvin 250mg
Levofloxacin………..250mg Levofloxacin………..250mg
(Quaper’s Specs.) (USP Specs.)
2. 048928 Quvin 500mg Quvin 500mg
Levofloxacin………..500mg Levofloxacin………..500mg
(Quaper’s Specs.) (USP Specs.)
The details of requirements as per SOP’s and the documents submitted by the firm are as
under:-

Application with required fee as per relevant Fee Rs.5000/- only dated 28-11-2018
SRO. If error is on part of firm. (Pages 310-311/C)
Copy of registration letter and renewal status. Copy of Registration letter dated 06-02-2008
(Page 312-314/C)
Last renewal due: 05-02-2018

Last Renewal applied: 08-01-2018 (page
316/C)
Documents in support of proposed correction The firm has provided copy of USP monograph
for product. The product is approved by
MHRA as film coated tablet.
Decision:-
ITEM NO. III: CASES FOR CORRECTION IN REGISTRATION/APPROVAL LETTER
Case No. 01: Correction of address in Registration Letters/approval letters of M/s. Medizan
Laboratories (Pvt.) Limited
M/s. Medizan Laboratories (Pvt) Limited, Islamabad have requested (page 78, 98 and
92/C) for correction of address in letters issued by DRAP as per following details.
Sr # Letter Ref. No Date

1. F.11-24/2005-Reg-II(North) 08-07-2013
2. F.11-24/2006-Reg-II(North) Vol-II 07-05-2011
3. F.11-24/2006-Reg-II(North) Vol-II 02-11-2010
4. F. 8-7/2016 Reg-III (M-262) 26-11-2017
5. F. 8-8/2016 Reg-III (M-263) 26-04-2017
6. F. 14-5/2018 Reg.III (PRVC-05) 19-03-2018.
The firm has submitted that the letters are issued with following address:
M/s. Medizan Laboratories, Plot # 313, Industrial Triangle Kahuta Road, Islamabad.
While the correct address mentioned on DML is:
M/s. Medizan Laboratories (Pvt.) Limited, Plot # 313, Industrial Triangle Kahuta
Road, Islamabad.
The firm has submitted following documents:

i. Copies of above letter (Pages 79-79A, 81-82, 84, 85, 91 & 96/C)
ii. Copy of DML valid at the time of issuance of letters (page 94/C)
iii. Renewal of DML dated 11-05-2015 (Page 95/C)
Decision:-
Case No. 02: Correction of address in Registration Letters/approval letters of M/s. Honig
Pharmaceuticals Laboratories, Rawalpindi
M/s. Honig Pharmaceuticals Laboratories, Rawalpindi have requested (page 97/C) for
correction of address in letters issued by DRAP as per following details.

1. No. F. 3-4/2004 Reg-II (M-186) 09-02-2005
2. No. F. 3-4/2004 Reg-II (M-186) 03-05-2007
3. No. F. 3-4/2004 Reg-II (M-186) 10-11-2004
4. No. F. 3-4/2004 Reg-II (M-186) 02-12-2004
5. No. F. 8-7/2017 Reg-III (M-271) 17-10-2017
6. No. F. 8-10/2017 Reg-III (M-274) 27-12-2017
7. No. F. 14-8/2018 Reg-III (PRVC-09) 26-06-2018
M/s. Honig Pharmaceuticals, 14th km, Adayala Road, Rawalpindi
M/s. Honig Pharmaceutical Laboratories, 14 km, Adayala Road, Rawalpindi

i. Copies of above letter (Pages 99-113/C)
ii. Copy of DML valid at the time of issuance of letters dated 28-08-2004 (page 98/C)
Decision:-
Case No. 03: Correction of address in Registration Letters/approval letters of M/s. Bio-
Labs, Islamabad
M/s. Bio-Labs, Rawalpindi have requested (Page 115/C) for correction of address in
letters issued by DRAP as per following details.

2 F. No. 13-8/2007 Reg-II (M-205) 07-05-2007
M/s. Bio-Labs (Pvt) Limited. 7, 2nd Floor, Allied Plaza, Chandni Chowk, Murree Road,
Rawalpindi
M/s. Bio-Labs, (Pvt.), Limited, Plot No. 145, Industrial Triangle, Kahuta Road,
Islamabad

i. Copy of above letter (Pages 115/C)
ii. Copy of DML valid at the time of issuance of letters (page 686/C of file of 20th PRVC)
Decision:-
Case No. 04: Correction of address in Registration Letters/approval letters of M/s. Agror
Pharma, Islamabad
M/s. Agror Pharma, Islamabad have requested (page 116/C) for correction of address in
letters issued by DRAP as per following details.

1. No. F. 8-2/2014 Reg-III (M-243) 18-06-2014
M/s. Agror Pharma, plot No. 4, street SS-4, national Industrial Zone, Rawat
M/s. Agror Pharma (Pvt.) Limited, plot No. 4, street SS4, National Industrial Zone,
Rawat, Rawalpindi

i. Initial Reg. letter no. 18-06-2014 (Pages 117-121/C)
Decision:-
Case No. 05: Correction of address in Registration Letters/approval letters of M/s. Ipram
International, Islamabad
M/s. Ipram International, Islamabad have requested (page 123/C) for correction of
address in letters issued by DRAP as per following details.

1. No. F. 8-6/2017 Reg-III (M-270) 26-09-2017
The firm has submitted that the letters are issued with following address:-
M/s. Ipram International Pharmaceuticals, Plot No. 26, Street no/ S.S-3, National
Industrial Zone (RCCI), Rawat, Islamabad
M/s. Ipram International, Plot No. 26, Street no. S.S-3, National Industrial Zone,
Rawat, Rawalpindi

i. Initial Reg. letter no. 26-09-2017 (Pages 125-127/C)
Decision:-
Case No. 06: Correction of address in Registration Letters/approval letters of M/s.

Fredmann Pharmaceuticals Pvt. Limited, Mirpur, Azad Kashmir
Dy. No. 892/2018 dated 01-10-2018
M/s. Fredmann Pharmaceuticals Pvt. Limited, Mirpur Azad Kashmir have requested
(page 129/C) for correction of address in letters issued by DRAP as per following details.

1. No. F. 8-2/2018 Reg-III (M-278) 21-05-2018
2. No. F. 8-3/2018 Reg-III (M-279) 25-06-2018
3. No. F. 8-3/2018 Reg-III (M-279) 09-07-2018
4. No. F. 8-5/2018 Reg-III (M-281) 26-06-2018
M/s. Fredmann Pharmaceuticals, Plot No. 82 & 83-B, old industrial Area, Mirpur, Azad
Kashmir
M/s. Fredmann Pharmaceuticals Pvt. Limited, Plot No. 82/83-B, Old industrial
Area, Mirpur, Azad Kashmir

i. Initial Reg. letter No. (Pages 131-136/C)
ii. Copy of DML valid at the time 21-12-2012 (page137/C)
iii. Renewal of Applied dated 10-01-2018 (Page 131-132/C)
Decision 22nd PRVC:-
Case No. 07: Correction of address in Registration Letters/approval letters of M/s. Bio-Labs,
Islamabad
M/s. Bio-Labs, Rawalpindi have requested (page 560/C) for correction of address in letters issued
by DRAP as per following details.

1. F. No. 13-8/2007 Reg-II (M-205) 26-04-2007
2. F. No. 13-8/2007 Reg-II (M-205) 05-05-2007
M/s. Bio-Labs (Pvt) Limited. 7, 2nd Floor, Allied Plaza, Chandni Chowk, Murree Road,
Rawalpindi
M/s. Bio-Labs, (Pvt.), Limited, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad
i. Fee Rs. 5000/- for each letter (Pages 558-560/C)

ii. Copies of above letter (Pages 570-573, 566-568/C)
iii. Copy of DML valid at the time of issuance of letters (page 686/C)
Decision 20th PRVC:-
The Committee evaluated the case in the light of SOPs approved by the Registration Board.
Chairman Registration Board, upon recommendation(s) of Committee decided to approve the
request of M/s Bio-Labs, Islamabad for correction in address of firm in above mentioned letters.
For further deliberation case refer to Registration Board.
Case No. 08: Correction of address in Registration Letters/approval letters of M/s. Webros
Pharmaceuticals, Islamabad.
Dy. No. 66/2018 dated 10-01-2019
M/s. Webros Pharmaceuticals, Islamabad have requested for correction of address in

letters issued by DRAP as per following detail.

1. No. F. 3-1/2004 Reg-II (M-182) 21-05-2018
M/s. M/s. Webros Pharmaceuticals, Plot # 1, Street No. S-9, RCCI, Industrial Estate
Islamabad.
M/s. M/s. Webros Pharmaceuticals, Plot # 1, Street No.10, RCCI, Industrial Estate
Islamabad.

i. Initial Registration letter
ii. Copy of DML valid at the time 01-04-2004
iii. Renewal of Applied dated 10-01-2018 (Page 131-132/C)
RRR Section
Sr. No. Details of cases No. of cases

Complete cases
1. Locally manufactured registered drugs (Human), June 2018 393
2. Locally manufactured registered drugs (Veterinary), June 2018 34
3. Pending cases 75
Incomplete cases
4. Locally manufactured registered drugs (Human), June 2018 116
5. Locally manufactured registered drugs (Veterinary), June 2018 04
6. Imported registered drugs from reference countries (Human) June 2018 17
7. Imported registered drugs from non-reference countries (Human) June, 2018 54
8. Pending cases 20
Miscellaneous cases
9. Left over Agenda of 287 meeting of Registration Board 158
10. Other cases. 4
Total Case 875
COMPLETE CASES
a. Locally manufactured registered drugs (Human)
Sr. Reg. No. Brand Name, Initial date Date of Renewal Remarks (if any)
No Composition & of application validity
Specification Registratio (R&I)
n Fee submitted
i. M/s Adamjee Pharmaceuticals, Plot No. 39, Sector 15, Korangi Industrial Area, Karachi.
1. 048757 Arfacobal Tablet 18-07-2008 Dy. No. 20291 Label claim may be
Each Tablet dated 05-06- revised as per innovator
Contains: 2018 description.
Mecobalamin…500 20000/-
mcg
ii. M/s. AGP Limited, B-23-C, S.I.T.E., Karachi.
2. 048800 QTP 100mg Tablet 21-07-2008 Dy. No. 21871
Each Tablet dated 22-06-
Contains: 2018
Quetiapine Fumarate
eq. to 10,000/-
Quetiapine…100mg
Each tablet contains: dated 22-06-
Quetiapine Fumarate 2018
eq. to
Quetiapine…..200mg 10,000/-
Quetiapine Fumarate 2018
eq. to
Quetiapine…..25mg 10,000/-
5. 014888 Dolofen Cream 24-02-1994 Dy. No. 21854
Each 100gm dated 22-6-18
contains: Transfer of
Ibuprofen registration 10000/-
B.P…..100gm 17-7-2008
6. 015107 Oslin Injection 05-03-1994 Dy. No. 21855

Each ml contains: dated 22-6-18
Lincomycin HCl Transfer of
equivalent to 300mg registration 10000/-
Lincomycin base dated: 17-7-
2008
7. 014885 Afiten Syrup 24-02-1994 Dy. No. 21859
Ketotifen…..1mg Transfer of
registration 10000/-
dated: 17-7-
2008
8. 014886 Afiten Syrup 24-02-1994 Dy. No. 21860
Ketotifen…..0.2mg Transfer of
dated: 17-7-
2008
9. 014242 Gluconorm Tablet 05-08-1993 Dy. No. 21846
Gliclazide…..80mg Transfer of 2008
registration
dated: 17-7- 10000/-
2008
10. 021625 Lidocaine 1% 20-05-1998 Dy. No. 21845
Injection dated 22-6-
Transfer of 2008
registration
dated 17-7- 10000/-
2008
11. 022992 Neuroptal Injection 11-02-1999 Dy. No. 21844
Each ml contains: dated 22-6-
Thiamine Transfer of 2008
HCl….100mg registration
Pyridoxine dated 17-7- 10000/-
HCl…..100mg 2008
Cyanocobalamin…
…...100mcg
12. 048717 Esi-dep 10mg 16-07-2008 Dy. No. 21857
Tablets dated 22-6-
Each tablet contains: 2008
Escitalopram (as
oxalate)….10mg
13. 016909 Algocin Infusion 16-04-1995 Dy. No. 21847
Each 100ml contains: dated 22-6-
Ciprofloxacin Transfer of 2008
Lactate….254.4mg registration
(corresponding to dated 17-7- 10000/-
ciprofloxacin)….200 2008
mg
14. 022945 Dagravit Tablets 11-02-1999 Dy. No. 21853

Vitamin A….2500IU Transfer of 2008
Vitamin registration
B1…..1.5mg dated 17-7- 10000/-
Vitamin B2….1.5mg 2008
Nicotinamide……10
mg
Calcium d
Pentothenate……1.5
mg
Vitamin
B6……0.5mcg
Vitamin
B12…..0.5mcg
Folic Acid…..50mcg
Biotin…..12.5mcg
P. Aminobenz
Acid….2mg
Vitamin C….20mg
Vitamin
D3…..500IU
Vitamin E…..1mg
Vitamin K3….0.5mg
MINERALS
Iron……5mg
Calcium Cal.
Phosphorus
Phosph……250mg
Potassium…..5mg
Magnesium……5mg
Aluminium…….5mg
Copper…..0.5mg
Maganese……0.5mg
Zinc……0.5mg
Iodine……50mcg
Molydenium……50
mcg
Fluorine……50mcg
Nickle………50mcg
Selenium……..50mc
g
15. 014436 Spasler Plus 14-10-1993 Dy. No. 21856
Capsules dated 22-6-
Each capsule Transfer of 2008
contains: registration
Paracetamol dated and 2- 10000/-
B.P……500mg 7-1999 &
Hyoscine Butyl 17-7-2008
bromide
B.P……10mg
16. 016912 Afoxin Tablet 16-04-1995 Dy. No. 21848

Enoxacin Transfer of 2008
Sesquihydrate registration
…..400mg dated 17-7- 10000/-
2008
17. 048718 Esi-dep 20mg Tablet 16-07-2008 Dy. No. 21858

Each tablet contains: dated 22-6-18
Escitalopram (as
Oxalate)….20mg 10000/-
18. 048716 Lucast Sachet 16-07-2008 Dy. No. 21851
Each sachet contains: dated 22-6-18
Montelukast (as
sodium)…..4mg 10000/-
19. 021624 Water for Injection 20-5-1998 Dy. No. 21850
dated 22-6-18
Transfer of
dated 17-7-
2008
iii. M/s Akhai Pharmaceuticals (Pvt) Ltd., A-248 toA-256, H.I.T.E., Lasbela, Baluchistan.
20. 015744 Aclova 5% Cream 07-09-1994 Dy. No. 22657
Each gm contains: dated 29-06-
Acyclovir…50mg Transfer 2018 10000/-
from import
to local
dated 19-7-
2008
21. 015743 Aclova 200mg 07-09-1994 Dy. No. 22656
Tablet dated
Transfer 29-06-2018
Acyclovir…200mg from import 10000/-
to local
dated 19-7-
2008
22. 021188 Aclova 400mg 15-10-1998 Dy. No. 22655
Tablet dated 29-06-
Each tablet contains: Transfer 2018
Acyclovir…400mg from import
10000/-
to local
dated 19-7-
2008
iv. M/s Ali Industries, 239-C, Sundar Industrial Estates, Raiwind Road, Lahore
23. 076920 Jazofen Suspension 21-06-2013 Dy. No. 21120
Ibuprofen…100mg 2018
10000/-
24. 076922 Co-Trifa Suspension 21-06-2013 Dy. No. 21119
Trimethoprim…40m 2018
g 10000/-
Sulphamethoxazole
…200mg
25. 076919 Dilonide Syrup 21-06-2013 Dy. No. 21121
Each 10ml Contains: dated 12-06-
Metronidazole 2018
Benzoate eq. to 10000/-
metronidazole…200
mg
Diloxanide
Furoate…250mg
26. 076921 Almage Syrup 21-06-2013 Dy. No. 21123
Aluminum 2018
Hydroxide…215mg 10000/-
Magnesium
Hydroxide…80mg
Simethicone…25mg
27. 076918 Alimol Syrup 21-06-2013 Dy. No. 21122
Paracetamol…120m 2018
g 10000/-
v. M/s Amson Vaccines & Pharma, 154, Industrial Triangle, Kahuta Road, Islamabad
28. 029071 Loramine Syrup 31-12-2002 Dy. No. 20961
Loratadine…5mg 2018
10000/-
29. 029072 Loramine Tablet 31-12-2002 Dy. No. 20961
10mg dated 11-06-
Each Tablet 2018
Contains: 10000/-
Loratadine…10mg
30. 029971 Amsozine Syrup 06-03-2003 Dy. No. 20961
Cetirizine HCl eq. to 2018
Cetirizine…5mg
10000/-
31. 029972 Amsozine 10 Tablet 06-03-2003 Dy. No. 20961
Contains: 2018
Cetirizine…10mg
10000/-
32. 030991 Rifason Tablet 06-09-2003 Dy. No. 20961
Contains: 2018
Rifampicin…60mg
Isoniazid…30mg 10000/-
33. 030992 Amzid Tablet 06-09-2003 Dy. No. 20961
Contains: 2018
Rifampicin…150mg
34. 030993 Pisoriz Tablet 06-09-2003 Dy. No. 20961
Contains: 2018
Rifampicin…60mg
Pyrazinamide…150
mg
35. 030994 Ethrifin Tablet 06-09-2003 Dy. No. 20961
Contains: 2018
Ethambutol
HCl…300mg 10000/-
Rifampicin…150mg
Isoniazid…75mg
36. 050189 Famcivir Tablet 22-07-2008 Dy. No. 20961
250mg dated 11-06-
Each Tablet 2018
Contains:
Famciclovir…250mg 10000/-
37. 050190 Sindam-P Tablet 22-07-2008 Dy. No. 20961
1st Tablet Contains: dated 11-06-
Artesunate…50mg 2018
2nd Tablet Contains:
Sulfadoxine…500mg 10000/-
38. 050191 Sindam-P DS Tablet 22-07-2008 Dy. No. 20961
1st Tablet Contains: dated 11-06-
Artesunate…100mg 2018
2nd Tablet Contains:
Sulfadoxine…500mg 10000/-
39. 050192 Migrex Tablet 50mg 22-07-2008 Dy. No. 20961
Contains: 2018
Sumatriptan as
Succinate…50mg 10000/-
40. 050193 Oxiflox Tablet 22-07-2008 Dy. No. 20961
400mg dated 11-06-
Each Tablet 2018
Contains:
Moxifloxacin as 10000/-
HCl…400mg
41. 050849 Geman Tablet 01-08-2008 Dy. No. 20961
Contains: 2018
Gemifloxacin (as
Mesylate)…320mg 10000/-
vi. M/s Atco Laboratories, B/18, S.I.T.E., Karachi.
42. 030904 Bracin D Sterile 25-07-2003 Dy. No. 22653
Ophthalmic dated 29-06-
Suspension 2018
Each ml contains:
Tobramycin…3.00m 10000/-
g
Dexamethasone…1.0
0mg
43. 030905 Merol 25mg Tablet 25-07-2003 Dy. No. 22653
Metoprolol 2018
Tartrate…25mg
10000/-
44. 030903 Polytrol Sterile 25-07-2003 Dy. No. 22653
Suspension 2018
Each ml contains:
Neomycin 10000/-
Sulphate…6.78mg
Dexamethasone…1.0
0mg
Polymyxin B
Sulphate…1.15mg
vii. M/s. Ethical Laboratories, 26-Shahrah-e-Quaid-e-Azam, Lahore
45. 006248 Pilocar Eye Drops 13-04-1982 Dy. No. 20731
4% Change of dated 08-06-
Contains: brand name 2018
Pilocarpine (Ethicar)
HCl…4% dated 22-06- 10,000/-
Boric Acid…0.140% 1998
Potassium
Chloride…0.06%
Sodium
Carbonate…0.022%
46. 006247 Pilocar Eye Drops 13-04-1982 Dy. No. 20730
2% Change of dated 08-06-
Contains: brand name 2018
Pilocarpine Hcl…2% (Ethicar)
Boric Acid…0.413% dated 22-06- 10,000/-
Potassium 1998
Chloride…0.25%
Sodium
Carbonate…0.006%
viii. M/s Fredmann Pharmaceuticals Pvt. Ltd. AJK
47. 075445 Fenacare 60mg 14-06-2013 Dy. No. 20957
Tablet dated 11-06-
Each Tablet 2018
Contains:
Fexofenadine 10000/-
HCl…60mg
48. 075446 Amlow 5mg Tablet 14-06-2013 Dy. No. 20957
Contains: 2018
Amlodipine (as
Besylate)…5mg
10000/-
49. 075447 Amlow 10mg Tablet 14-06-2013 Dy. No. 20957
Contains: 2018
Amlodipine (as
Besylate)…10mg
10000/-
ix. M/s FYNK Pharmaceuticals, 19-Km, G.T. Road, Kalashah Kaku, Lahore
50. 030336 Lopemid Capsule 27-06-2003 Dy. No. 21125
2mg dated 12-06-
Each Capsule 2018
Contains: 10000/-
Loperamide
HCl…2mg
51. 030335 Fycam Capsule 27-06-2003 Dy. No. 21125
Each Capsule dated 12-06-
Contains: 2018
Piroxicam…10mg 10000/-
x. M/s GlaxoSmithKline Pakistan Limited,35- Dockyard Road West Wharf Karachi.
52. 000249 Betnsol Eye 20-4-1976 Dy. No. 22502
Ointment Transfer of dated 28-06-
Contains: registration: 2018
Betamethasone 30-08-2003 10000
sodium phosphate
B.P….0.1%
53. 004506 Betnesol Injection 20-11-1978 Dy. No. 22502
Each 1ml contains: Transfer of dated 28-06-
Betamethasone as registration: 2018
sodium phosphate 30-08-2003 10000/-
BP…..4mg
54. 000251 Betnesol N Eye 20-4-1976 Dy. No. 22502
sodium phosphate
B.P….0.1%
Neomycin sulphate
BP…….0.5%
55. 000254 Betnovate N Cream 20-4-1976 Dy. No. 22501
Contains: Transfer of dated 28-06-
Betamethasone as registration: 2018
valerate BP….0.1%
Neomycin sulphate
BP….0.5%
56. 000255 Betnovate N 20-4-1976 Dy. No. 22501
Betamethasone as 30-08-2003 10000
Betamethasone
valerate BP….0.1%
Neomycin sulphate
BP….0.5%
57. 000252 Betnovate N Lotion 20-4-1976 Dy. No. 22501
20ml Transfer of dated 28-06-
Betamethasone
valerate BP….0.1%
w/v
Neomycin sulphate
BP….0.5% w/v
58. 000256 Betnovate Cream 20-4-1976 Dy. No. 22501
5gm Transfer of dated 28-06-
Betamethasone
valerate BP….0.1%
w/v
59. 000257 Betnovate Ointment 20-4-1976 Dy. No. 22501
5gm Transfer of dated 28-06-
Betamethasone
valerate BP….0.1%
w/w
60. 000253 Betnovate Lotion 20-4-1976 Dy. No. 22501
20ml Transfer of dated 28-06-
Betamethasone
valerate BP….0.1%
w/v
61. 000348 Actidil Elixir 17-04-1976 Dy. No. 22297
Triprolidine 2018
HCl…1.25mg 10000/-
62. 010399 Bactroban Ointment 19-02-1990 Dy. No. 22297
Contains: dated 26-06-
Mupirocin 2% w/w 2018
in Water Soluble 10000/-
Base
xi. M/s GlaxoSmithKline Pakistan Limited F-268 SITE Karachi.
63. 006669 Amoxil Capsule 20-07-1999 Dy. No. 22298 Approval of Penicillin
500mg dated 26-06- Block was given on F-
Each Capsule 2018 268, however products
Contains: were transferred on D-
Amoxycillin as 10000/- 43 Textile Avenue
Amoxycillin Karachi.
Trihydrate…500mg
64. 000509 Amoxil Drops 16-04-1976 Dy. No. 22298 -do-
125mg dated 26-06-
Each 1.25ml 2018
Contains:
Amoxycillin as 10000/-
Trihydrate
Amoxycillin…125m
g
65. 000508 Amoxil Syrup 16-04-1976 Dy. No. 22298 -do-
125mg dated 26-06-
Each 5ml contains: 2018
Amoxycillin as
Trihydrate 10000/-
Amoxycillin…125m
g
66. 006814 Amoxil Forte Syrup 07-03-1986 Dy. No. 22298 -do-
250mg dated 26-06-
Amoxycillin as
Trihydrate
Amoxycillin…250m 10000/-
g
67. 000182 Ampiclox Capsule 17-04-1976 Dy. No. 22499 -do-
500mg dated 28-06-
Each Capsule 2018
Contains:
Ampicillin as
Ampicillin 10000/-
Trihydrate…250mg
Cloxacillin as
Cloxacillin
Sodium…250mg
68. 000183 Ampiclox Drops 16-04-1976 Dy. No. 22499 -do-
90mg dated 28-06-
Each 0.6ml Contains: 2018
Ampicillin as
Ampicillin
Trihydrate…60mg 10000/-
Cloxacillin as
Cloxacillin
Sodium…30mg
69. 000194 Ampiclox Syrup 17-04-1976 Dy. No. 22499 -do-
250mg dated 28-06-
Ampicillin as
Ampicillin
Cloxacillin as
Cloxacillin
Sodium…125mg
70. 000248 Betnesol Drops 20-04-1976 Dy. No. 22296
Betamethasone 2018
Sodium
Phosphate…0.1%
w/v 10000/-
71. 000250 Betnesol N Drops 20-04-1976 Dy. No. 22296
Betamethasone 2018
Sodium
Phosphate…0.1%
w/v 10000/-
Neomycin
Sulphate…0.5% w/v
72. 013113 Panadol CF Tablet 12-12-1991 Dy. No. dated
Paracetamol…..500
mg
Pseudoephedrine 10000/-
HCl….60
Chlorpheniramine
Maleate….4mg
73. 000394 Iodex Ointment 24-03-1976 Dy. No. dated
13-06-2018
000/-
74. 016868 ENO Fruit Salt 18-04-1995 Dy. No. dated
Lemon 13-06-2018
Contains:
Sodium
Bicarbonate…..34.16 10,000/-
%w/w
Sodium Bicarbonate
Fine….11.39%w/w
Citric Acid
Anhydrous….43.10
%
Sodium
Carbonate(anhydrous
)…10.00%w/w
Sodium Carbonate
Decahydrate….0.25
%
xii. M/s. Genix Pharma, 44, 45-B, Korangi Creek Road, Karachi
75. 058397 Gen-M 80/480 26-08-2008 Dy. No. 21269
Tablet dated 13-06-
Artemether…80mg
Lumefantrine…480 10,000/-
mg
76. 048747 Rosca 10mg Tablet 17-07-08
Rosuvastatin (as
Calcium)……10mg
(Manufacturer’s
Specification)
77. 048748 Rosca 20mg Tablet 17-07-08
Rosuvastatin (as
Calcium)……20mg
(Manufacturer’s
Specification)
78. 075985 D4U 5mg Drops 17-07-13
Each 5ml contains:
Cholecalciferol
(Vitamin D3)
……..5mg
(Manufacturer’s
Specification)
79. 048745 Freal 35mg Tablet 17-07-08
Each film coated
contains:
Risedronate as
Sodium……35mg
(Manufacturer’s
Specification)
80. 048743 Gedox 4mg Tablet 17-07-08
Doxazosin (as
Mesylate)……..4mg
(Manufacturer’s
Specification)
81. 048735 Lendrol-D Tablet 17-07-08
Alendronate Sodium
eq. to
Alendronic
Acid…….70mg
Cholicalciferol……..
70mg
(Manufacturer’s
Specification)
82. 050322 Gen-Art SP Tablet 26-07-08
Each co-blister
contains:
Three tablets contain:
Sulfadoxine…..500m
g
Primethamine……25
mg
Six tablets contain:
Artesunate…….100
mg
(Manufacturer’s
Specification)
83. 048741 RBC-F Chewable 17-07-08
Tablet
Each Chewable
tablet contains:
Iron (III) Hydroxide
Polymaltose
Complex eq. to
Elemental
Iron…..100mg
Folic
Acid…….0.35mg
(Manufacturer’s
Specification)
84. 048742 RBC Syrup 17-07-08
Each 5ml contains:
Polymaltose
Complex eq. to
Elemental
Iron…..50mg
(Manufacturer’s
Specification)
85. 075970 X-Gen Infusion 04-07-13
Each ml contains:
Moxifloxacin HCl
eq. to
Moxifloxacin…..1.6
mg
(Manufacturer’s
Specification)
xiii. M/s. Geofman Pharmaceuticals, 20/23, Korangi Industrial Area, Karachi
86. 00996-EX Geof-Cefixime 100 13-06-2008 Dy. No. 20738
Suspension dated 08-06-
Each 5ml Sachet 2018
Upon Reconstitution
Contains: 10,000/-
Cefixime Trihydrate
(Micronized)…118.0
0mg
Citric Acid…4.80mg
Sodium
Benzoate…2.66mg
Xanthan
Gum…5.00mg
Aerosil…33.00mg
Banana
Flavor…13.33mg
Sugar/Sucrose…249
0.33mg
xiv. M/s. Hilton Pharma, Plot 13 & 14, Sector 15, Korangi Industrial Area, Karachi.
87. 022107 Hinit Oral 11-07-1998 Dy. No. 21928
Cefuroxime
Axetil…125mg 10,000/-
88. 022108 Cefim Suspension 11-07-1998 Dy. No. 21928
Cefixime…100mg 2018
10,000/-
89. 048773 Xofi 400mg Tablet 18-07-2008 Dy. No. 21928
Contains: 2018
Doxofylline…400mg
10,000/-
th
| 887
90. 048774 Zepla 20mg Capsule 18-07-2008 Dy. No. 21928
Contains: 2018
Ziprasidone (as HCl
Monohydrate)…20m 10,000/-
g
91. 048775 Zepla 40mg Capsule 18-07-2008 Dy. No. 21928
Contains: 2018
Ziprasidone (as HCl
Monohydrate)…40m 10,000/-
g
92. 030926 Gevolox Plus Tablet 31-07-2003 Dy. No. 21928
Contains: 2018
Glucosamine
Sulphate…500mg 10,000/-
Chondroitin
Sulphate…200mg
Calcium
Carbonate…75mg
Vitamin C…25mg
xv. M/s Helix Pharma, Hakimsons House, A-56, S.I.T.E., Manghopir Road, Karachi
93. 030596 Diaxin Oral 14-06-2003 Dy. No. 20960
Suspension dated
Each 5ml Contains: 11-06-2018
Clarithromycin…125 10000/-
mg
94. 030605 Efectal Tablet 120mg 14-06-2003 Dy. No. 20960
Each Tablet dated
Contains: 11-06-2018
Fexofenadine 10000/-
HCl…120mg
95. 030595 Floral Eye Drops 14-06-2003 Dy. No. 20960
0.1% dated
Each ml Contains: 11-06-2018
Flurometholone…1m 10000/-
g
96. 030602 Floral Forte Eye 14-06-2003 Dy. No. 20960
Drops 0.25% dated
Flurometholone…2.5 10000/-
mg
97. 030286 Ironal Tablet 14-06-2003 Dy. No. 20960
Each Tablet dated
Iron (III) Hydroxide 10000/-
Polymaltose
Complex is eq. to
100mg of Iron
Elemental Iron
98. 030287 Ironal-F Tablet 14-06-2003 Dy. No. 20960
Each Tablet dated
Iron (III) Hydroxide 10000/-
Polymaltose
Complex is eq. to
100mg of Iron
Elemental Iron
Folic Acid…0.35mg
99. 030603 Ironal Syrup 14-06-2003 Dy. No. 20960
Each 5ml Contains: dated
Iron (III) Hydroxide 11-06-2018
Polymaltose 10000/-
Complex is eq. to
Elemental
Iron…50mg
100. 030604 Oflocin Tablet 14-06-2003 Dy. No. 20960
400mg dated
Each Tablet 11-06-2018
Contains: 10000/-
Ofloxacin…400mg
101. 030594 Oflocin Eye Drops 14-06-2003 Dy. No. 20960
0.3% dated
Ofloxacin…3mg 10000/-
102. 030598 Recept Tablet 2mg 14-06-2003 Dy. No. 20960
Each Tablet dated
Risperidone…2mg 10000/-
103. 030599 Recept Tablet 4mg 14-06-2003 Dy. No. 20960
Each Tablet dated
Risperidone…4mg 10000/-
xvi. M/s. Indus Pharma, Plot No. 65 Sector-27, Korangi Industrial Area, Karachi
104. 030610 Lignocaine 30-06-2003 Dy. No. 21268
Hydrochloride 1% dated 13-06-
W/V Injection 2018
Each ml contains:
Lignocaine 10,000/-
HCl…10mg
xvii. M/s. Leads Pharma, Plot # 81-A, Street # 6, I-10/3, Islamabad
105. 035878 Levocin 250mg Tab 10-01-2005 Dy. No. 21286
Levofloxacin Transfer of 2018
Hemihydrate eq. to registration
Levofloxacin…250m dated 25-6- 10,000/-
g 2008
106. 035879 Levocin 500mg Tab 10-01-2005 Dy. No. 21286

Levofloxacin Transfer of 2018
Hemihydrate eq. to registration
Levofloxacin…500m dated 25-6- 10,000/-
g 2008
107. 035880 Lefox 250mg Tablet 10-01-2005 Dy. No. 21286
Ciprofloxacin HCl Transfer of 2018
eq. to registration
Ciprofloxacin…250 dated 25-6- 10,000/-
mg 2008
108. 035881 Lefox 500mg Tablet 10-01-2005 Dy. No. 21286
Ciprofloxacin HCl Transfer of 2018
eq. to registration
Ciprofloxacin…500 dated 25-6- 10,000/-
mg 2008
109. 035882 Leceph 250mg 10-01-2005 Dy. No. 21286
Capsule dated 13-06-
Cephradine…250mg dated 08-07- 10,000/-
2008
110. 035883 Leceph 500mg 10-01-2005 Dy. No. 21286
Cephradine…500mg dated 08-07- 10,000/-
2008
111. 035885 Leceph 250mg 10-01-2005 Dy. No. 21286
Each 5ml contains: Transfer of 2018
Cephradine…250mg registration
dated 08-07- 10,000/-
2008
112. 035886 Leceph 500mg 10-01-2005 Dy. No. 21286
Each ml contains: Transfer of 2018
dated 08-07- 10,000/-
2008
113. 035887 Klaricil 250mg 10-01-2005 Dy. No. 21286
Tablet dated 13-06-
Each tablet contains: Transfer of 2018
Clarithromycin…250 registration
mg dated 25-6- 10,000/-
2008
114. 035888 Klaricil 500mg 10-01-2005 Dy. No. 21286
Tablet dated 13-06-
Each tablet contains: Transfer of 2018
Clarithromycin…500 registration
mg dated 25-6- 10,000/-
2008
115. 035889 Ratadil 10mg Tablet 10-01-2005 Dy. No. 21286
Loratadine…10mg Transfer of 2018
registration
dated 25-6- 10,000/-
2008
116. 035892 Penapol 40mg Tablet 10-01-2005 Dy. No. 21286
Pantoprazole (as Transfer of 2018
Sodium)…40mg registration
dated 25-6- 10,000/-
2008
117. 035893 Flurle 100mg Tablet 10-01-2005 Dy. No. 21286
Flurbiprofen…100m Transfer of 2018
g registration
dated 25-6- 10,000/-
2008
118. 035894 Azimik 250mg 10-01-2005 Dy. No. 21286
Azithromycin (as dated 25-6- 10,000/-
Dihydrate)…250mg 2008
119. 035895 Azimik 200mg 10-01-2005 Dy. No. 21286
Azithromycin (as registration
Dihydrate)…200mg dated 25-6- 10,000/-
2008
120. 035896 Ceftrol 250mg 10-01-2005 Dy. No. 21286
Each Vial Contains: Transfer of 2018
Ceftriaxone Sodium registration
eq. to dated 08-07- 10,000/-
Ceftriaxone…250mg 2008
121. 035897 Ceftrol 500mg 10-01-2005 Dy. No. 21286
eq. to dated 08-07- 10,000/-
Ceftriaxone…500mg 2008
122. 035898 Ceftrol 1000mg 10-01-2005 Dy. No. 21286
eq. to dated 08-07- 10,000/-
Ceftriaxone…1000m 2008
g
123. 035899 Futazim 250mg 10-01-2005 Dy. No. 21286
Each vial contains: Transfer of 2018
Cefotaxime Sodium registration
eq. to dated 08-07- 10,000/-
Cefotaxime…250mg 2008
124. 035900 Futazim 500mg 10-01-2005 Dy. No. 21286
eq. to dated 08-07- 10,000/-
Cefotaxime…500mg 2008
125. 036301 Futazim 1gm 10-01-2005 Dy. No. 21286
eq. to dated 08-07- 10,000/-
Cefotaxime…1gm 2008
xviii. M/s Mediate Pharmaceuticals Pvt Limited, 150-151 Sector 24, Korangi Industrial Area Karachi
126. 048693 Medisid 100mg 15-07-2008 Dy. No. 1724
Tablet dated 07-06-
Flurbiprofen……100
mg 10000
(USP Specification)
127. 048694 M-Kort 4mg Tablet 15-07-2008 Dy. No. 1725
Triamcinolone 2018
acetonide….4mg
(USP Specification) 10000
128. 048695 Domprog 10mg 15-07-2008 Dy. No. 1716
Tablet dated 07-06-
Domperidone
maleate eq. to 10000
Domperidone……10
mg
(USP Specification)
129. 048696 M-Naxem 250mg 15-07-2008 Dy. No. 1723
Tablet dated 07-06-
Naproxen as
sodium……250mg 10000
(USP Specification)
130. 048697 M-Naxem 500mg 15-07-2008 Dy. No. 1722
Tablet dated 07-06-
Naproxen as
sodium……500mg 10000
(USP Specification)
131. 048698 Domprog 5mg/ 5ml 15-07-2008 Dy. No. 1717
Domperidone
……5mg 10000
(USP Specification)
132. 048699 Antidine 20mg 15-07-2008 Dy. No. 1721
Tablet dated 07-06-
Famotidine……20m
g 10000
(BP Specification)
133. 048700 Antidine 40mg 15-07-2008 Dy. No. 1728
Tablet dated 07-06-
Famotidine……20m
g 10000
(BP Specification)
134. 048701 Ulsac 1g Tablet 15-07-2008 Dy. No. 1719
Sucralfate……1g 2018
(USP Specification)
10000
135. 048702 Medifenac 50mg 15-07-2008 Dy. No. 1726
Tablets dated 07-06-
Diclofenac
sodium….50mg 10000
(BP Specification)
136. 048703 Medifenac SR 15-07-2008 Dy. No. 1727
100mg Tablets dated 07-06-
Diclofenac
sodium….100mg 10000
(BP Specification)
137. 048704 Mexicam 7.5mg 15-07-2008 Dy. No. 1720
Tablet dated 07-06-
Meloxicam……..7.5
mg 10000
(BP Specification)
138. 048705 Mexicam 15mg 15-07-2008 Dy. No. 1718
Tablet dated 07-06-
Meloxicam……..15
mg 10000
(BP Specification)
xix. M/s Metro Pharmaceutical, Plot 14, Street No. SS-2, National Industrial Zone, RCCI, Rawat,
Islamabad
139. 075441 Emzol 20mg Capsule 13-06-2013 Dy. No. 20958
Contains: 2018
Esomeprazole (as
Enteric Coated 20000/-
Pellets) eq. to
Esomeprazole…20m
g
Source of Pellets:
M/s Spansule
Formulations, Sy.
No. 172 , Plot No.
154 /A /4, IDA
Bollaram Village
Jinnaram Mandal
Medac District
AndrPardesh
Hyderabad India.
140. 075442 Emzol 40mg Capsule 13-06-2013 Dy. No. 20958
Contains: 2018
Esomeprazole (as
Pellets) eq. to
Esomeprazole…40m
g
Source of Pellets:
M/s Spansule
Formulations, Sy.
No. 172 , Plot No.
154 /A /4, IDA
Bollaram Village
Jinnaram Mandal
Medac District
AndrPardesh
Hyderabad India.
141. 075443 Omefit 20mg 13-06-2013 Dy. No. 20958
Each Capsule 2018
Contains:
Omeprazole (as 20000/-
Enteric Coated
Pellets) eq. to
Omeprazole…20mg
Source of Pellets:
Source of Pellets:
M/s Spansule
Formulations, Sy.
No. 172 , Plot No.
154 /A /4, IDA
Bollaram Village
Jinnaram Mandal
Medac District
AndrPardesh
Hyderabad India.
142. 075444 Legzol 30mg 13-06-2013 Dy. No. 20958
Each Capsule 2018
Contains:
Lansoprazole (as 20000/-
Enteric Coated
Pellets) eq. to
Lansoprazole…30mg
Source of Pellets:
M/s Spansule
Formulations, Sy.
No. 172 , Plot No.
154 /A /4, IDA
Bollaram Village
Jinnaram Mandal
Medac District
AndrPardesh
Hyderabad India.
143. 075238 Mestom Tablet 02-04-2013 Dy. No. 20018
Each film coated dated 01-06-
tablet contains: 2018
Escitalopram as
Oxalate … 10mg 20000/-
144. 075239 Melcin 250mg Tablet 02-04-2013 Dy. No. 20018
tablet contains: Change of 2018
Levofloxacin as brand name
Hemihydrate…250m dated 11-10- 20000/-
g 2013
145. 075240 Melcin 500mg Tablet 02-04-2013 Dy. No. 20018
tablet contains: Change of 2018
Levofloxacin as brand name
Hemihydrate…500m dated 11-10- 20000/-
g 2013
146. 075241 Metrose-F Tablet 02-04-2013 Dy. No. 20018
Each chewable tablet dated 01-06-
contains: 2018
Iron-III Hydroxide
Polymaltose 20000/-
Complex eq.
Elemental
Iron…100mg
Folic Acid…0.35mg
147. 075242 Mendon 10mg Tablet 02-04-2013 Dy. No. 20018
Domperidone (as
Maleate)…10mg 20000/-
148. 075243 Metein-250 Tablet 02-04-2013 Dy. No. 20018
Ciprofloxacin (as
HCl)…250mg 20000/-
149. 075244 Metein-500 Tablet 02-04-2013 Dy. No. 20018
Ciprofloxacin (as
HCl)…500mg 20000/-
150. 075245 Perzol 40mg Tablet 02-04-2013 Dy. No. 20018
Each enteric coated dated 01-06-
Pantoprazole as
Sodium 20000/-
Sesquihydrate eq. to
Pantoprazole…40mg
151. 075246 Metost 10mg Tablet 02-04-2013 Dy. No. 20018
Montelukast as
Sodium…10mg 20000/-
152. 075250 Mezethro-250 02-04-2013 Dy. No. 20018
Each capsule 2018
contains:
Azithromycin as 20000/-
Dihydrate…250mg
153. 075251 M.Gob-300 Capsule 02-04-2013 Dy. No. 20018
Each capsule dated 01-06-
contains: 2018
Gabapentin…300mg
20000/-
154. 075252 Metadryl Syrup 02-04-2013 Dy. No. 20018
Aminophylline…32 2018
mg
Diphenhydramine 20000/-
HCl…8mg
Ammonium
Chloride…30mg
Menthol…0.98mg
155. 075253 Myzine Syrup 02-04-2013 Dy. No. 20018
Zinc Sulfate 2018
Monohydrate…20mg
20000/-
156. 075254 Iromas Syrup 02-04-2013 Dy. No. 20018
Iron-III Hydroxide Change of 2018
Polymaltose brand name
Complex eq. dated 15-7- 20000/-
Elemental 2015
Iron…50mg
157. 75255 Mega-One 02-04-2013 Dy. No. 20018
Magaldrate…540mg
Simethicone…20mg 20000/-
158. 75256 Levotaiz Syrup 02-04-2013 Dy. No. 20018
Levocetirizine 2018
Dihydrochloride…2.
5mg 20000/-
159. 75257 Mydin Syrup 02-04-2013 Dy. No. 20018
Loratadine…5mg 2018
20000/-
160. 75258 Sofet Suspension 02-04-2013 Dy. No. 20018
Sucralfate…1gm 2018
20000/-
161. 75259 Metofam Suspension 02-04-2013 Dy. No. 20018
Famotidine…10mg Change of 2018
brand name
dated 15-7- 20000/-
2015
162. 75260 Mendon Suspension 02-04-2013 Dy. No. 20018
Domperidone…5mg 2018
20000/-
163. 75261 Homglob Syrup 02-04-2013 Dy. No. 20018
Iron Protein 2018
Succinylate……800
mg 20000/-
eq. to Elemental
Iron…40mg
164. 75262 Mezethro-200 Dry 02-04-2013 Dy. No. 20018
Each 5ml Contains: 2018
Azithromycin (as
Dihydrate)…200mg 20000/-
165. 75267 Lumet Dry 02-04-2013 Dy. No. 20018
Artemether…15mg
Lumefantrine…90m 20000/-
g
166. 75268 Claramet 125mg Dry 02-04-2013 Dy. No. 20018
Clarithromycin…
125mg 20000/-
167. 75269 Fosic Cream 02-04-2013 Dy. No. 20018
Fusidic Acid as 2018
Hemihydrate…20mg
(2%) 20000/-
168. 75270 Parten 5% Cream 02-04-2013 Dy. No. 20018
Permethrin…50mg 2018
20000/-
169. 75271 Catazol-V 10% 02-04-2013 Dy. No. 20018
Cream dated 01-06-
Each gm contains: 2018
Clotrimazole…100m
g 20000/-
170. 75272 Mesocam 0.5% Gel 02-04-2013 Dy. No. 20018
Each 25gm Tube dated 01-06-
Contains: 2018
Piroxicam…0.5%
20000/-
171. 75273 Demobid Gel 02-04-2013 Dy. No. 20018
Each 20gm Tube dated 01-06-
Contains: 2018
Diclofenac
Diethylamine…1% 20000/-
172. 75275 Meteda Sachet 02-04-2013 Dy. No. 20018
Each sachet contains: dated 01-06-
Sodium 2018
Bicarbonate…1.716g
m 20000/-
Citric
Acid…0.702gm
Sodium
Citrate…0.613gm
Tartaric
Acid…0.858gm
173. 75276 Metost 4mg Sachet 02-04-2013 Dy. No. 20018
Montelukast as 2018
(Sodium)…4mg
20000/-
174. 75277 Bestsol Sachet 02-04-2013 Dy. No. 20018
Sodium 2018
Chloride…2.6gm
Sodium 20000/-
Citrate…2.9gm
Potassium
Chloride…1.5gm
Dextrose
Anhydrous…13.5gm
xx. M/s Moringa Pharmaceuticals, 35-A Sundar Industrial Estate, Raiwind Road, Lahore.
175. 074461 Ad-Cough Syrup 18-04-2013 01-06-2018
Each 5ml Contains:
Aminophylline…32
mg
Diphenhydramine
HCl…8.0mg 20000/-
Ammonium
Chloride…30mg
Menthol …..0.98mg
176. 074462 L-Trizine Syrup 18-04-2013 01-06-2018
Each 5ml Contains:
Levocetirizine
Dihydrochloride……
.2.5mg
20000/-
177. 074463 Gasidon Suspension 18-04-2013 01-06-2018
Each ml Contains:
Domperidone…1mg
20000/-
178. 074464 Ibumor Suspension 18-04-2013 01-06-2018
Each 5ml Contains:
Ibuprofen…100mg
20000/-
179. 074469 Moparum Dry 18-04-2013 01-06-2018
Suspension
Each 5ml Contains:
Artemether…15mg
Lumefantrine…90m 20000/-
g
180. 074459 Amphozole Capsule 18-04-2013 01-06-2018
150mg
Each Capsule
Contains:
Fluconazole…150mg 20000/-
xxi. M/s Nabiqasim Industries, 17/24, Korangi Industrial Area, Korangi, Karachi
181. 00995-EX Duosar Tablet 13-06-2008 Dy. No. 21118
Each Film Coated dated 12-06-
Tablet Contains: 2018
Losartan
Potassium…50mg
Hydrochlorothiazide 10000/-
…12.5mg
xxii. M/s Noa Hemis Pharmaceuticals, Plot No. 154 Sector 23 Korangi Industrial Area Karachi
182. 075981 Equp 100mg Tablet 04-07-2013 Dy. No. 22158 03-07-2018
Quetiapine 2018
Fumarate…..100mg
(Manufacturer 10000/-
Specifications)
183. 075982 Equp-D 200mg 04-07-2013 Dy. No. 22158 03-07-2018
Tablet dated 07-06-
Quetiapine
Fumarate…..100mg 10000/-
(Manufacturer
Specifications)
184. 075983 Snapta 100mg Tablet 04-07-2013 Dy. No. 22158 03-07-2018
Sertraline
HCl…….100mg 10000/-
(BP Specification)
185. 075984 Orthoflex Forte 04-07-2013 Dy. No. 22158 03-07-2018
50mg/ 650mg Tablet dated 07-06-
Orphenadrine
Citrate…50mg 10000/-
Paracetamol…….650
mg
(BP Specification)
186. 050480 Ucon Capsule 21-08-2008 Dy. No. 22159
Contains: 2018
Fluconazole…150mg
10,000/-
187. 50481 Gabagyl 100mg 21-08-2008 Dy. No. 22159
Each Capsule 2018
Contains:
Gabapentin…100mg 10,000/-
188. 50482 Gabagyl 300mg 21-08-2008 Dy. No. 22159
Each Capsule 2018
Contains:
189. 50483 Gabagyl 400mg 21-08-2008 Dy. No. 22159
Each Capsule 2018
Contains:
190. 50484 Febagyl Tablet 21-08-2008 Dy. No. 22159
Contains: 2018
Flurbiprofen…100m
g 10,000/-
191. 50485 Taixa Tablet 21-08-2008 Dy. No. 22159 Tizanidine tablets are
Each Tablet dated 25-06- composed of the active
Contains: 2018 ingredient, tizanidine
Tizanidine hydrochloride (2.288
HCl…2mg 10,000/- mg equivalent to 2 mg
tizanidine base. Label
claim requires
correction.
192. 50486 Rabista Tablet 21-08-2008 Dy. No. 22159
Each Enteric Coated dated 25-06-
Rabeprazole (as
Sodium)…20mg 10,000/-
193. 50487 Oxiloc Tablet 21-08-2008 Dy. No. 22159
Contains: 2018
Moxifloxacin (as
HCl)…400mg 10,000/-
194. 50488 Xoxilum 7.5mg 21-08-2008 Dy. No. 22159
Tablet dated 25-06-
Each Tablet 2018
Contains:
Meloxicam…7.5mg 10,000/-
195. 50489 Xoxilum 15mg 21-08-2008 Dy. No. 22159
Tablet dated 25-06-
Each Tablet 2018
Contains:
Meloxicam…15mg 10,000/-
196. 50490 Klarida Tablet 21-08-2008 Dy. No. 22159
Contains: 2018
Clarithromycin…250
mg 10,000/-
197. 50491 Klarida DS Tablet 21-08-2008 Dy. No. 22159
Contains: 2018
mg 10,000/-
198. 075979 Rexa 30mg Capsule 04-07-2013 Dy. No. 22158 03-07-2018
Each capsule dated 07-06-
contains: 2018
Duloxetine HCL
enteric coated pellets 20000/-
eq. to
Duloxetine….30mg
Source of Pellets:
M/s Spansule
Formulations, Sy.
No. 172 , Plot No.
154 /A /4, IDA
Bollaram Village
Jinnaram Mandal
Medac District
AndrPardesh India.
199. 075980 Rexa-D 60mg 04-07-2013 Dy. No. 22158 03-07-2018
Each capsule 2018
contains:
Duloxetine HCL 20000/-
enteric coated pellets
eq. to
Duloxetine….60mg
Source of Pellets:
M/s Spansule
Formulations, Sy.
No. 172, Plot No.
154 /A /4, IDA
Bollaram Village
Jinnaram Mandal
Medac District
AndrPardesh India.
xxiii. M/s. Panacea Pharmaceuticals, Plot # 4, Street # S-6, National Industrial Zone, Rawat, Islamabad
200. 50172 O-Lanz 10mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Olanzapine…10mg
10,000/-
201. 50173 Recam 7.5mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Meloxicam…7.5mg
10,000/-
202. 50175 O-Lanz 5mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Olanzapine…5mg
10,000/-
203. 50177 Lecetra 5mg 23-07-2008 Dy. No. 22654
Tablet/Le-Vox 5mg dated 07-06-
Tablet 2018
Each Tablet
Contains: 10,000/-
Levocetirizine as
2HCl…5mg
204. 50178 Moxilox 400mg 23-07-2008 Dy. No. 22654
Tablet dated 07-06-
Each Tablet 2018
Contains:
Moxifloxacin (as 10,000/-
HCl)…400mg
205. 50179 U-Fit 40mg Tablet 23-07-2008 Dy. No. 22654
Famotidine…40mg
10,000/-
206. 50180 Na-Zole 150mg 23-07-2008 Dy. No. 22654
Each Capsule 2018
Contains:
Fluconazole…150mg 10,000/-
207. 50181 Napum 550mg 23-07-2008 Dy. No. 22654
Tablet dated 07-06-
Each Tablet 2018
Contains:
Naproxen 10,000/-
Sodium…550mg
208. 50182 Ri-One 10mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Domperidone…10m
g 10,000/-
209. 50183 Clap 75mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Clopidogrel as
Bisulphate…75mg 10,000/-
210. 50185 Pasic 100mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Flurbiprofen…100m
g 10,000/-
211. 50186 Fastec 120mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Fexofenadine as
HCl…120mg 10,000/-
212. 50187 Fastec 60mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Fexofenadine as
HCl…60mg 10,000/-
213. 50188 U-Fit 60mg Tablet 23-07-2008 Dy. No. 22654
Contains: 2018
Famotidine…20mg
10,000/-
xxiv. M/s Paramount Pharmaceuticals, 36-Industrial Triangle, Kahuta Road, Islamabad
214. 21859 Fertin Tablet 09-06-1998 Dy. No. 20293
Contains: 2018
Vitamin
A…30,000IU 10,000/-
Vitamin E…70mg
215. 21860 Healet Tablet 200mg 11-07-1998 Dy. No. 20293
Contains: 2018
Cimetidine…200mg
10,000/-
216. 21862 Healet Tablet 400mg 11-07-1998 Dy. No. 20293
Contains: 2018
Cimetidine…400mg
10,000/-
217. 021862 Vitalet-M Tablet 09-06-1998 Dy. No. 20293
Contains: 2018
Vitamin A…5500IU
Vitamin E…30IU 10,000/-
Vitamin D…400IU
Vitamin B1…3.0mg
Riboflavin…3.4mg
Pyrodoxine
HCl…3.0mg
Cyanocobalamine…
9.0mg
Nicotinamide…30m
g
Pantothenic
Acid…10mg
Ascorblic
Acid…120mg
Folic Acid…0.4mg
Magnesium…100mg
Calcium…40mg
Zinc..15mg
Manganese...5mg
Iron...27mg
Copper...2mg
Chloride...7.5mg
Potassium...7.5mg
Iodine...150mcg
Molybdenum...15mc
g
Biotin...15mcg
Chromium...15mcg
Selenium...10mcg
218. 021863 Vitalet-H Tablet 09-06-1998 Dy. No. 20293
Contains: 2018
Vitamin A
Acetate…8.333IU 10,000/-
Vitamin E…5.0IU
Vitamin D…133IU
Thiamine
Monohydrate…3.3m
g
Riboflavin…3.3mg
Cynocobalamine…5
0mcg
Nicotinamide…33.3
mg
Calcium
Pantothenate…11.7m
g
Ascorbic
Acid…100mg
Folic Acid…0.33mg
Magnesium…41.7m
g
Iron…66.7mg
Copper…0.67mg
xxv. M/s. Pharmatec Pakistan, D-86/A, S.I.T.E., Karachi
219. 04204-EX Apocam 7.5mg 20-07-2013 Dy. No. 21548
Tablet dated 19-06-
Meloxicam…7.5mg
10,000/-
220. 4205-EX Apocam 15mg 20-07-2013 Dy. No. 21548
Tablet dated 19-06-
Meloxicam…15mg
10,000/-
221. 4206-EX Prepase Tablet 20-07-2013 Dy. No. 21548
Losartan Potassium
…. 50mg 10,000/-
222. 4207-EX Prepase H Tablet 20-07-2013 Dy. No. 21548
Losartan Potassium
…. 50mg 10,000/-
Hydrochlorothiazide
…12.5mg
223. 20341 Alerid Syrup 31-10-1997 Dy. No. 21548
Cetirizine Change of 2018
Dihydrochloride …. brand name
05mg (Histex) 10,000/-
dated: 18-
08-1998
xxvi. M/s. Platinum Pharmaceuticals, A-20, North Western Industrial Zone, Bin Qasim, Karachi
224. 30202 Seizunil SR Tablet 17-07-2003 Dy. No. 21285
400mg dated
Carbamazepine…40
0mg 10,000/-
225. 30208 Losar Plus Tablet 17-07-2003 Dy. No. 21285
Each tablet contains: dated
Losartan 13-06-2018
Potassium…50mg
Hydrochlorothiazide 10,000/-
…12.5mg
226. 30204 Apofer Syrup 17-07-2003 Dy. No. 21285
50mg/5ml dated
Each 5ml contains: 13-06-2018
Polymaltose 10,000/-
Complex…50mg
227. 30203 Fastaid-R Dispersible 17-07-2003 Dy. No. 21285
Tablet 50mg dated
Diclofenac Acid eq.
to Diclofenac 10,000/-
Sodium…50mg
228. 30911 Topirama Tablet 26-07-2003 Dy. No. 21285
25mg dated
Topiramate…25mg
10,000/-
229. 30835 Topirama Tablet 26-07-2003 Dy. No. 21285
100mg dated
Topiramate…100mg
10,000/-
230. 30906 Lustral Tablet 50mg 26-07-2003 Dy. No. 21285
Each tablet contains: dated
Sertraline 13-06-2018
HCl…50mg
10,000/-
231. 48537 Gerdpill 20mg 10-03-2008 Dy. No. 21835
Capsule dated
Each capsule 22-06-2018
contains:
Enteric coated pellets 10,000/-
of Esomeprazole
Magnesium
Trihydrate eq. to
Esomerazole ….
20mg
232. 48538 Gerdpill 40mg 10-03-2008 Dy. No. 21835
Capsule dated
Each capsule 22-06-2018
contains:
Enteric coated pellets 10,000/-
of Esomeprazole
Magnesium
Trihydrate eq. to
Esomerazole ….
40mg
xxvii. M/s P.D.H. Laboratories (Pvt) Ltd. 9.5-Km, Sheikhupura Road, (Khaki) Lahore
233. 030506 Kuin Tablet 250mg 30-06-2003 Dy. No. 20954
Contains: 2018
Ciprofloxacin HCl 10000/-
eq. to
Ciprofloxacin…250
mg
234. 030507 Kuin Tablet 500mg 30-06-2003 Dy. No. 20954
Contains: 2018
Ciprofloxacin HCl 10000/-
eq. to
Ciprofloxacin…500
mg
xxviii. M/s PharmEvo (Private) Limited, A-29, North Western Industrial Zone, Port Qasim, Karachi.
235. 001006- RTflox 500mg 1-7-2008 Dy. No. 21893
EX Tablets dated 22-6-
Levofloxacin as
hemihydrate…500m
g
236. 001007- Deprino 10mg Tablet 1-7-2008 Dy. No. 21893
EX Each tablet contains: dated 22-6-
Escitalopram as 2018
oxalate……..10mg
237. 001008- Deprino 5mg Tablet 1-7-2008 Dy. No. 21893
EX Each tablet contains: dated 22-6-
Escitalopram as 2018
oxalate……..5mg
238. 001009- RTflox 250mg 1-7-2008 Dy. No. 21893
Levofloxacin as
hemihydrate…250m
g
239. 001010- Bonlife 70mg 1-7-2008 Dy. No. 21893
Alendronic acid as
sodium
alendronate….70mg
xxix. M/s. Synchro Pharmaceuticals, 77-Industrial Estate, Kot Lakhpat, Lahore
240. 076923 Synklar Dry 25-06-2013 Dy. No. 21752
Suspension 125mg dated 21-06-
Clarithromycin…
125mg 10,000/-
241. 076924 Fosfosyn Dry 25-06-2013 Dy. No. 21752
Fosfomycin Calcium
eq. to 10,000/-
Fosfomycin…250mg
242. 076925 Synocip Suspension 25-06-2013 Dy. No. 21752
125mg dated 21-06-
Ciprofloxacin as
HCl…125mg 10,000/-
243. 076926 Synfant Suspension 25-06-2013 Dy. No. 21752
Artemether…15mg 2018
Lumefantrine…90m
g 10,000/-
244. 076927 Synocip Suspension 25-06-2013 Dy. No. 21752
250mg dated 21-06-
Ciprofloxacin as
HCl…250mg 10,000/-
245. 076928 Linlid Powder 25-06-2013 Dy. No. 21752
Linezolid…100mg
10,000/-
246. 076929 Synkast Dry 25-06-2013 Dy. No. 21752
Montelukast Sodium
eq. to 10,000/-
Montelukast…5mg
247. 076930 Syncon Suspension 25-06-2013 Dy. No. 21752
50mg dated 21-06-
Fluconazole … 50mg
10,000/-
248. 076931 Venagro Tablet 25-06-2013 Dy. No. 21752
100mg dated 21-06-
Polymaltose 10,000/-
Complex eq. to
Elemental
Iron…100mg
249. 076932 Moflox Tablet 25-06-2013 Dy. No. 21752
400mg dated 21-06-
Each film coated 2018
tablet contains:
Moxifloxacin as 10,000/-
HCl…400mg
250. 076933 Synfant Tablet 25-06-2013 Dy. No. 21752
Artemether…40mg 2018
Lumefantrine…240
mg 10,000/-
251. 076934 Allerzin Tablet 10mg 25-06-2013 Dy. No. 21752
Cetirizine 2018
HCl…10mg
10,000/-
252. 076935 Synkast Tablet 10mg 25-06-2013 Dy. No. 21752
Montelukast 2018
Sodium…10mg
10,000/-
253. 076936 Synocip Tablet 25-06-2013 Dy. No. 21752
500mg dated 21-06-
tablet contains:
Ciprofloxacin as 10,000/-
HCl…500mg
254. 076937 Aclonac-K Tablet 25-06-2013 Dy. No. 21752
50mg dated 21-06-
Diclofenac
Potassium…50mg 10,000/-
255. 076938 Synocip Tablet 25-06-2013 Dy. No. 21752
250mg dated 21-06-
tablet contains:
Ciprofloxacin as 10,000/-
HCl…250mg
256. 076939 Linlid Tablet 600mg 25-06-2013 Dy. No. 21752
Linezolid…600mg 2018
10,000/-
257. 076940 Camtrin Tablet 20mg 25-06-2013 Dy. No. 21752
Piroxicam Beta- 2018
Cyclodextrin eq to
Piroxicam … 20mg 10,000/-
258. 076941 Comcin Capsule 25-06-2013 Dy. No. 21752
500mg dated 21-06-
Each capsule 2018
contains:
Lincomycin (as 10,000/-
HCl)…500mg
259. 076942 Syncon Oral Capsule 25-06-2013 Dy. No. 21752
150mg dated 21-06-
Each capsule 2018
contains:
Fluconazole … 10,000/-
150mg
260. 076943 Camtrin Capsule 25-06-2013 Dy. No. 21752
20mg dated 21-06-
Each capsule 2018
contains:
Piroxicam Beta- 10,000/-
Cyclodextrin eq to
Piroxicam … 20mg
261. 076944 Venagro-F Capsule 25-06-2013 Dy. No. 21752
100mg dated 21-06-
Each capsule 2018
contains:
Iron (III) Hydroxide 10,000/-
Polymaltose
Complex eq. to
Elemental
Iron…100mg
Folic Acid…0.35mg
262. 076945 Solanz Capsule 25-06-2013 Dy. No. 21752
30mg dated 21-06-
Each capsule 2018
contains:
Lansoprazole…30mg 10,000/-
263. 076946 Proset Capsule 25-06-2013 Dy. No. 21752
0.4mg dated 21-06-
Each capsule 2018
contains:
Tamsulosin 10,000/-
HCl…0.4mg
xxx. M/s. Schazoo Zaka, Kalawala, 20-KM, Lahore-Jaranwala Road, Dist: Sheikhupura
264. 044992 Liverton 200mg 01-03-2007 20-06-2018 Renewal granted vide
Tablet Transfer of SRO 1005(1)/2017
Each tablet contains: registration 10000/- dated 23-05-2018
Silymarin…200mg dated 28-06-
2008
265. 09933 Rifapin 300mg 15-09-1988 20-06-2018 Renewal granted vide
Capsule Transfer of SRO 1005(1)/2017
Each capsule registration 10000/- dated 23-05-2018
contains: dated 28-06-
Rifampicin…300mg 2008
266. 028900 Bizole 200mg 21-08-2002 20-06-2018 Renewal granted vide
Ribavirin…200mg 2008
267. 025539 Pyrazid Dry Syrup 01-02-2000 20-06-2018 Renewal granted vide
Each 5ml contains: Transfer of SRO 1005(1)/2017
Pyrazinamide…200 registration 10000/- dated 23-05-2018
mg dated 28-06-
2008
268. 06945 Rifapin 150mg 10-10-1983 20-06-2018 Renewal granted vide
Rifampicin…150mg 2008
269. 028901 Bizole 400mg 21-08-2002 20-06-2018 Renewal granted vide
Ribavirin…400mg 2008
xxxi. M/s. Sante (Pvt) Limited, 97-A, S.I.T.E. Super Highway, Karachi
270. 007501 Optoflox Ophthalmic 04-09-1997 Dy. No. 2202
Solution 0 dated 25-06-
Each ml Contains: 2018
Ofloxacin…3mg
10,000/-
271. 007784 Levosan Solution 30-08-1997 Dy. No. 22020
Each ml Contains: dated 25-06-
Levobunolol 2018
HCl…5mg
10,000/-
272. 011039 Blink Fresh Solution 30-08-1997 Dy. No. 22020
Each ml Contains: dated 25-06-
Polyvinyl 2018
Alcohol…14mg
Povidone…6mg 10,000/-
273. 021604 Optolube Sterile Eye 20-05-1998 Dy. No. 22020
Ointment dated 25-06-
Each gm Contains: 2018
Paraffin
Liquid…425mg 10,000/-
Lanolin
Alcohol…20mg
White
Petrolatum…549.75
mg
Chlorobutanol as
Preservative………
…..5.25mg
274. 021605 Santochlor Sterile 20-05-1998 Dy. No. 22020
Ophthalmic Solution dated 25-06-
Contains: 2018
Chloramphenicol…0.
5% 10,000/-
275. 021608 Optoflox Sterile Eye 20-05-1998 Dy. No. 22020
Contains: 2018
Ofloxacin…0.3%
10,000/-
276. 021609 Santochlor Sterile 20-05-1998 Dy. No. 22020
Eye Ointment dated 25-06-
Contains: 2018
Chloramphenicol…0.
1% 10,000/-
277. 021610 Betalol Sterile Eye 04-07-2013 Dy. No. 22020
Timolol…5.0mg
10,000/-
278. 022423 Optofen Ophthalmic 14-12-1998 Dy. No. 22020
Solution dated 25-06-
Contains: 2018
Sodium
Fluribiprofen…0.03 10,000/-
%
279. 022424 Ocuflur Ophthalmic 14-12-1998 Dy. No. 22020
Contains: 2018
Fluorometholone…0.
1% 10,000/-
280. 023325 Santovir Ophthalmic 16-04-1999 Dy. No. 22020
Acyclovir…30mg
10,000/-
281. 023326 Oculerg Ophthalmic 16-04-1999 Dy. No. 22020
Antazoline
HCl…0.5mg 10,000/-
Tetrahyderzoline
HCl…0.4mg
282. 023328 Tropic Ophthalmic 16-04-1999 Dy. No. 22020
Tropicamide…10mg
10,000/-
283. 024659 Natasan Ophthalmic 24-04-2002 Dy. No. 22020
Natamycin…50mg
10,000/-
284. 025660 Santirol Ophthalmic 08-01-2001 Dy. No. 22020
Neomycin (as
Neomycin 10,000/-
Sulfate)…3.5mg
Polymyxin B
Sulfate…6000mg
Dexamethasone…1.0
mg
285. 026391 Ketrosan 0.5% 30-09-2000 Dy. No. 22020
Sterile Ophthalmic dated 25-06-
Solution 2018
Each ml Contains:
Ketrolac 10,000/-
Tromethamine…5mg
286. 026911 Santobrex 12-05-2001 Dy. No. 22020
Ointment 2018
Each gm Contains:
Tobramycin…3.0mg 10,000/-
287. 026912 Santobrex Dy. No. 22020
Tobramycin…3.0mg
10,000/-
288. 030354 Ocuflur Forte 06-05-2003 Dy. No. 22020
Suspension 2018
Each ml Contains:
Fluorometholone…2. 10,000/-
5mg
289. 030355 Tears Forte 06-05-2003 Dy. No. 22020
Dextran…1.0mg
Hydroxy Propyl 10,000/-
Methyl
Cellulose…3.0mg
290. 030360 Fusigel viscous Eye 06-05-2003 Dy. No. 22020
Drops dated 25-06-
Fusidic Acid…10mg
10,000/-
291. 030361 Bakcin Ophthalmic 06-05-2003 Dy. No. 22020
Ciprofloxacin (as
Ciprofloxacin 10,000/-
HCl…)…3mg
292. 030362 Salub Ophthalmic 06-05-2003 Dy. No. 22020
Solution 2% dated 25-06-
Sodium
Chloride…20mg 10,000/-
293. 032590 Optoflox Plus 20-05-2004 Dy. No. 22020
Ofloxacin…3.0mg
10,000/-
294. 032592 Florozil Ophthalmic 20-05-2004 Dy. No. 22020
Fluorometholone
(10% 10,000/-
excess)…1.1mg
Sodium
Cromoglycate…40m
g
295. 032593 Ocuflur PN 20-05-2004 Dy. No. 22020
Suspension 2018
Each ml Contains:
Fluorometholone…1. 10,000/-
2mg
Polymyxin B
Sulphate…5000Unit
Neomycin (as
Neomycin
Sulphate)…3.5mg
296. 034768 Co-Dorzal 06-12-2004 Dy. No. 22020
Dorzolamide HCl eq.
to 10,000/-
Dorzolamide…20mg
Timolol Maleate eq.
to Timilol…5mg
297. 037033 Ocuflur Ophthalmic 10-02-2005 Dy. No. 22020
Each 100gm 2018
Contains:
Flurometholone…1g 10,000/-
m
298. 037034 Santobet Ophthalmic 10-02-2005 Dy. No. 22020
Betaxolol (as
HCl)…5mg 10,000/-
299. 037037 Salub Ophthalmic 10-02-2005 Dy. No. 22020
Solution 5% dated 25-06-
Sodium
Chloride…50mg 10,000/-
300. 037041 Santolev Ophthalmic Dy. No. 22020
Levofloxacin eq. to
Levofloxacin…5mg 10,000/-
301. 037900 Hylosan Ophthalmic 18-05-2005 Dy. No. 22020
Solution 0.18% dated 25-06-
Sodium
Hyaluronate…0.18% 10,000/-
302. 037921 Trutears Liquigel 1% 18-05-2005 Dy. No. 22020
Carboxy Methyl
Cellulose 10,000/-
Sodium…10mg
303. 039283 Ximer Ophthalmic 06-12-2005 Dy. No. 22020
Gatifloxacin…3.0mg
10,000/-
304. 039491 Quixin Plus 26-07-2005 Dy. No. 22020
1.5% 2018
Each ml Contains:
Levofloxacin 10,000/-
Hemihydrate
15.36mg eq. to
Levofloxacin…15mg
305. 039492 Kerovit A 26-07-2005 Dy. No. 22020
Ointment 2018
Each gm Contains:
Vitamin A (as 10,000/-
Palmitate)…250IU
306. 042016 Megamox 08-12-2005 Dy. No. 22020
0.5% Sterile 2018
Each ml Contains:
Moxifloxacin (as 10,000/-
HCl)…5.0mg
307. 048527 Zyclat Ophthalmic 07-03-2008 Dy. No. 22020
Solution Sterile dated 25-06-
Latanoprost…50mcg
(0.005%) 10,000/-
Timolol (as Timolol
Maleate)…5mg(0.5
%)
308. 061775 Xepat Ophthalmic 02-08-2010 Dy. No. 22020
Olopatadine as
HCl…1mg 10,000/-
309. 061776 Brimolol Ophthalmic 02-08-2010 Dy. No. 22020
Brimonidine
Tartrate…2.0mg 10,000/-
Timolol as
Maleate…5.0mg
310. 067458 Lotepred Forte 26-02-2011 Dy. No. 22020
Suspension 0.5% 2018
Each ml Contains:
Loteprednol 10,000/-
Etabonate…5mg
311. 067459 Lotepred Ophthalmic 26-02-2011 Dy. No. 22020
Suspension 0.2% dated 25-06-
Loteprednol
Etabonate…2mg 10,000/-
312. 067460 Xepat Forte 26-02-2011 Dy. No. 22020
0.2% 2018
Each ml Contains:
Olopatadine as 10,000/-
HCl…2mg
313. 067645 Vislat Ophthalmic 13-04-2011 Dy. No. 22020
Latanoprost…50mcg
10,000/-
314. 070515 Lotepred-T 28-04-2011 Dy. No. 22020
Suspension 2018
Each ml Contains:
Tobramycin…3.0mg 10,000/-
Loteprednol
Etabonate…5.0mg
xxxii. M/s S.J & G. Fazul Ellahie (Pvt) Ltd. E-46, S.I.T.E.Karachi
315. 048802 Nezkil 200mg 21-07-2008 08-06-2018
Infusion
Each ml contains: 10000/-
Linezolid…2mg
316. 048803 Nezkil 400mg 21-07-2008 08-06-2018
Infusion:
Linezolid…2mg
317. 048804 Nezkil 600mg 21-07-2008 08-06-2018
Infusion:
Linezolid…2mg
318. 031101 Motu 7.5mg Tablet 26-08-2003 08-06-2018
Meloxicam…7.5mg 10000/-
319. 031102 Motu 15mg Tablet 26-08-2003 08-06-2018
Meloxicam…15mg 10000/-
320. 004160 Droxryl 26-06-1978 08-06-2018
Cream/Ointment
20gm
Each gm contains: 20000/-
Bufexamac…50mg
321. 004203- Vervex Injection 02-07-2013 08-06-2018
EX 1gm IM
Each Vial Contains:
Ceftriaxone Sodium 10000/-
eq. to
Ceftriaxone…1.000g
m
xxxiii. M/s Sanofi-Aventis Pakistan, Plot No. 22, Korangi Industrial Area, Karachi.
322. 050375 Aventriax 250mg IV 05-08-2008 Dy. No. 20431
Each Vial Contains: 2018
Ceftriaxone (as
Sodium) … 250mg 10000/-
323. 050376 Aventriax 250mg IM 05-08-2008 Dy. No. 20432
Ceftriaxone (as
Sodium) … 250mg 10000/-
324. 050377 Aventriax 500mg IM 05-08-2008 Dy. No. 20434
Ceftriaxone (as
Sodium) … 500mg 10000/-
325. 050379 Aventriax 1gm IV 05-08-2008 Dy. No. 20435
Ceftriaxone (as
Sodium) … 1gm 10000/-
326. 050391 Aventriax 500mg IV 05-08-2008 Dy. No. 20433
Ceftriaxone (as
Sodium) … 500mg 10000/-
327. 050378 Aventriax 1gm IM 05-08-2008 Dy. No. 20436
Ceftriaxone (as
Sodium) … 1gm 10000/-
xxxiv. M/s Servier Research and Pharmaceuticals Pakistan Pvt Limited, 9-Km Sheikhupura Road,
Lahore
328. 014911 Stablon Tablets 09-02-1994 Dy. No. 12213
Each coated tablet dated 03-04-
contains: Import to 2018
Tianeptine as local
sodium transfer 10000
salt……..12.5mg approval
dated: 27-
09-2003
329. 027918 Vastarel MR Tablet 08-09-2008 Dy. No. 12212
Each tablet contains: (Re- dated 03-04-
Trimetazidine….35m registration 2018
g of drug)
10000
330. 014942 Trivastal Retard Dy. No. 12210
50mg Tablets dated 03-04-
Piribedil…..50mg
10000
xxxv. M/s Shaheen Pharmaceuticals, 3-Km, Murghzar Road, Saidu Sharif, Swat.
331. 077414 Easyast 10mg Tablet 28-06-2013 Dy. No. 21753
Montelukast Sodium
eq. to Montelukast 10000/-
…. 10mg
xxxvi. M/s Shrooq Pharmaceuticals, 21-Km, Ferozepur Road, Lahore.
332. 074341 Bonpac Tablet 12-04-2013 Dy. No. 20629
Ibandronate Sodium 20000/-
Monohydrate eq. to
Ibandronic
Acid…150mg
333. 074342 BioArt-DS 12-04-2013 Dy. No. 20629
Dispersible Tablet dated 05-06-
Each Tablet 2018
Contains: 20000/-
Artemether…40mg
Lumefantrine…240
mg
334. 074343 Cebenz Tablet 12-04-2013 Dy. No. 20629
Cyclobenzaprine 20000/-
HCl…10mg
335. 074344 Clof Gel 12-04-2013 Dy. No. 20629
Each gm Contains: dated 05-06-
Aceclofenac…1.5% 2018
w/w 20000/-
336. 074345 BioArt-Forte 12-04-2013 Dy. No. 20629
Dispersible Tablet dated 05-06-
Each Tablet 2018
Contains: 20000/-
Artemether…80mg
Lumefantrine…480
mg
337. 074346 Natifin Cream 12-04-2013 Dy. No. 20629 Reference product
Each gm Contains: dated 05-06- contains Naftifine
Naftifine (as 2018 hydrochloride instead
HCl)…1%w/w 20000/- of as hydrochloride
338. 074347 Benipro Tablet 12-04-2013 Dy. No. 20629
Probenecid…500mg 20000/-
339. 074348 Cebenz Tablet 12-04-2013 Dy. No. 20629
Cyclobenzaprine 20000/-
HCl…5mg
340. 074349 Termi Gel 12-04-2013 Dy. No. 20629
Each 100gm dated 05-06-
Contains: 2018
Terbinafine 20000/-
HCl…1.0%w/w
341. 074350 BioArt Dispersible 12-04-2013 Dy. No. 20629
Tablet dated 05-06-
Each Tablet 2018
Contains: 20000/-
Artemether…20mg
Lumefantrine…120
mg
xxxvii. M/s Standpharm Pakistan, 20-Km, Ferozepur Road, Lahore
342. 049938 Simib Tablet 17-07-2008 Dy. No. 22021
Simvastatin…10mg
Ezitimibe…10mg 10000/-
343. 049942 Cephinol Tablet 17-07-2008 Dy. No. 22021
100mg dated 25-06-
tablet contains:
Pyritinol 10000/-
HCl…100mg
344. 049943 Simib Forte Tablet 17-07-2008 Dy. No. 22021
Simvastatin…20mg
Ezitimibe…10mg 10000/-
345. 049944 Cephinol Liquid 17-07-2008 Dy. No. 22021
Pyritinol 2018
HCl…80.5mg
10000/-
346. 049945 A-Mal Injection 17-07-2008 Dy. No. 22021
Each ampoule dated 25-06-
contains: 2018
Artemether…80mg 10000/-
347. 049946 Kolex Tablet 10mg 17-07-2008 Dy. No. 22021
Simvastatin…10mg 2018
10000/-
10000/-
10000/-
350. 049949 Sapride Tablet 25mg 17-07-2008 Dy. No. 22021
Levosulpiride…25m 2018
g 10000/-
351. 049950 Sapride Tablet 50mg 17-07-2008 Dy. No. 22021
Levosulpiride…50m 2018
g
10000/-
352. 049951 Sapride Tablet 17-07-2008 Dy. No. 22021
100mg dated 25-06-
Levosulpiride…100
mg 10000/-
353. 049953 Patin Tablet 20mg 17-07-2008 Dy. No. 22021
Paroxetine asChange of 2018
HCl…20mg brand name
dated: 02- 10000/-
10-2009
354. 049954 Nervex Tablet 17-07-2008 Dy. No. 22021
300mg dated 25-06-
Gabapentin…300mg
10000/-
355. 049955 Bronkeez Chewable 17-07-2008 Dy. No. 22021
Tablet 4mg dated 25-06-
Montelukast (as
Sodium)…4mg 10000/-
356. 049956 Ophen Tablet 17-07-2008 Dy. No. 22021
Aceclofenac…100m 2018
g
10000/-
357. 049958 Tromit Injection 17-07-2008 Dy. No. 22021
30mg/ml dated 25-06-
Each 1ml ampoule 2018
contains:
Ketorolac 10000/-
Tromethamine…30m
g
358. 049961 Amlotin 10mg Tablet 17-07-2008 Dy. No. 22021
dated 25-06-
Contains: 2018
Amlodipine Besylate
eq. to 10000/-
Amlodipine…10mg
Atorvastatin Calcium
eq. to
Atorvastatin…10mg
359. 049962 Amlotin Forte Tablet 17-07-2008 Dy. No. 22021
Amlodipine Besylate 2018
eq. to
Amlodipine…10mg 10000/-
Atorvastatin Calcium
eq. to
Atorvastatin…20mg
360. 049963 Megnil Tablet 17-07-2008 Dy. No. 22021
Zolmitriptan…2.5mg
10000/-
xxxviii. M/s Swat Pharmaceuticals, Saidu Sharif Road Amankot Swat.
361. 021628 Panaset Tablet 20-05-1998 Dy. No. 20946
Contains: 2018
Paracetamol…500m 20000/-
g
Caffeine…65mg
xxxix. M/s. Tabros Pharma, L-20/B, Sector-22, F. B. Industrial Area, Karachi
362. 075990 E-Clar XL 500mg 30-08-2013 Dy. No. 20288
Tablet dated 05-06-
Each Extended 2018
Release Film Coated
Tablet Contains: 10,000/-
mg
363. 030985 Fusil-B Cream 18-09-2003 Dy. No. 22734

Fusidic Acid…20mg 2018
10,000/-
364. 030986 Fusil-HC Cream 18-09-2003 Dy. No. 22734
Fusidic Acid…20mg 2018
Hydrocortisone
Acetate…10mg 10,000/-
365. 030987 Nixim Tablet 18-09-2003 Dy. No. 22734
Nimesulide…100mg 2018
10,000/-
366. 076015 Uraxat 40mg Tablet 19-09-2013 Dy. No. 22735
Febuxostat…40mg
10,000/-
367. 076016 Valtec AMH 19-09-2013 Dy. No. 22735
5/160/12.5mg Tablet dated 29-06-
tablet contains:
Amlodipine Besylate 10,000/-
eq. to
Amlodipine…5mg
Valsartan…160mg
Hydrochlorothiazide
…12.5mg
368. 076017 Bisheart 2.5mg 19-09-2013 Dy. No. 22735
Tablet dated 29-06-
tablet contains:
Bisoprolol Fumarate 10,000/-
eq. to
Bisoprolol…2.5mg
xl. M/s Unexolabs, 9.5-Km, Sheikhupura Road, Lahore.
369. 022035 Dipotil Tablet 20-05-1998 Dy. No. 21605 Application was
Each tablet contains: dated 20-06- submitted after due date
Diphenoxylate 2018 but within sixty days.
HCl…2.5mg Accordingly firm
Atropine submitted differential
Sulphate…0.025mg 10000/- fee 10000/- dated 21-1-
2019.
370. 014271 Methacid Capsule 05-08-1993 Dy. No. 20441
25mg dated 06-06-
Each capsule 2018
contains:
Indomethacin…25m 10000/-
g
371. 009910 Semidine 400mg 15-09-1988 Dy. No. 20441
Tablet dated 06-06-
Cimetidine…400mg
10000/-
372. 009911 Empicil Capsule 15-09-1988 Dy. No. 20441
250mg dated 06-06-
Each capsule 2018
contains:
Ampicillin as
xli. M/s. Venus Pharma, 23 KM, Multan Road, Lahore
373. 030227 Oxynin Tablet 16-06-2003 Dy. No. 20623
Oxybutynin 2018
HCl...3mg
10,000/-
374. 030228 Metrolone Tablet 16-06-2003 Dy. No. 20623
Metronidazole 2018
Benzoate…321.60m
g 10,000/-
Di-
Iodohydroxyquinolo
ne…325mg
375. 030229 Lipinil-10 Tablet 16-06-2003 Dy. No. 20623
10,000/-
376. 030230 Lipinil-20 Tablet 16-06-2003 Dy. No. 20623
10,000/-
377. 030231 Vio-Chlor Tablet 16-06-2003 Dy. No. 20623
Chloroquine 2018
Phosphate 250mg eq.
to Chloroquine 10,000/-
Base…150mg
378. 030232 Vio-Cobal Injection 16-06-2003 Dy. No. 20623
Each ml contains: dated 07-06-
Mecobalamine…500 2018
mcg
10,000/-
379. 030233 Vio-Aqua Injection 16-06-2003 Dy. No. 20623
Water for 2018
Injection…5ml
10,000/-
xlii. M/s Wilson's Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad.
380. 072840 Sofvasc-Telm Tablet 18-08-2011 Dy. No. 21284
5/40mg dated 13-06-
Amlodipine 10000/-
Besylate…5mg
Telmisartan…40mg
5/80mg dated 13-06-
Amlodipine 10000/-
Besylate…5mg
Telmisartan…80mg
10/40mg dated 13-06-
Amlodipine 10000/-
Besylate…10mg
Telmisartan…40mg
xliii. M/s Xenon Pharmaceuticals, 9.5-Km, Sheikhupura Road, Lahore.
383. 021205 Dermistat Cream 25-04-1998 Dy. No. 21880 Renewal application is
Contains: dated 22-06- after due date but
Miconazole 2018 within sixty days with
Nitrate…2% 20000/- prescribed fee
384. 053602 Yoxi 400mg Tablet 04-12-2008 Dy. No. 21881
Moxifloxacin…400 2018
mg 10000/-
385. 053614 Fervol Tablet 04-12-2008 Dy. No. 21882
Each tablet contains; dated 22-06-
Iron (III) Hydroxide 2018
Polymaltose 10000/-
Complex eq. to
Elemental
Iron…100mg
Folic Acid…0.35mg
386. 053613 ASP Tablet 04-12-2008 Dy. No. 21883
Aspirin…75mg 2018
10000/-
387. 053600 Profox 250mg Tablet 04-12-2008 Dy. No. 21885
Ciprofloxacin…250 2018
mg 10000/-
388. 053601 Profox 500mg Tablet 04-12-2008 Dy. No. 21886
Ciprofloxacin…500 2018
mg 10000/-
389. 030998 Zepitor 10mg Tablet 30-10-2003 Dy. No. 21887
Atorvastatin (as 2018
Calcium)…10mg 10000/-
390. 030999 Zepitor 20mg Tablet 30-10-2003 Dy. No. 21888
Atorvastatin (as 2018
Calcium)…20mg 10000/-
391. 030403 Febricod-15 Tablet 05-07-2003 Dy. No. 21889
g 10000/-
Codeine…15mg
392. 030404 Febricod-30 Tablet 05-07-2003 Dy. No. 21890
g 10000/-
Codeine…30mg
393. 030405 Febricod-C Tablet 05-07-2003 Dy. No. 21891
g 10000/-
Codeine…15mg
Caffeine…15mg
b. Locally manufactured registered drugs (Veterinary)
Sr. Reg. Brand Name, Initial date Date of Renewal Remarks (if any)
No No. Composition & of application validity
Specification Registration (R&I)
Fee
submitted
xliv. M/s Elegance Pharmaceuticals, Chak Belli, Pandori Road, District Rawalpindi.
394. 049793 Enrotin Solution Transfer of Dy. No.
Each 100ml Contains: registration 22013 dated
Enrofloxacin…10gm dated 27-06- 25-06-2018
Colistin Sulphate…50MIU 2013 10000/-
xlv. M/s Elko Organization, Plot No. 27 & 28, Sector 12/B, North Karachi, Industrial Area, Karachi.
395. 075648 Levanil 13.65% Injection 03-06-2013 Dy. No.
Each ml Contains: 20016 dated
Levamisole HCl…13.65% 04-06-2018
10000/-
396. 075649 Clant Oral Suspension 03-06-2013 Dy. No.
Closantel…50mg 04-06-2018
10000/-
397. 075650 Fe-Zole 5% Oral 03-06-2013 Dy. No.
Suspension 20016 dated
Each gm Contains: 04-06-2018
Fenbendazole…5% 10000/-
398. 075651 Fe-Zole 10% Oral 03-06-2013 Dy. No.
Fenbendazole…10% 10000/-
xlvi. M/s Nawan Laboratories (Pvt) Ltd. 136, Sector 15, Korangi Industrial Area, Karachi.
399. 049514 Naflor Oral Solution 22-07-2008 Dy. No.
Florfenicol… 100mg 26-06-2018
10000/-
400. 049512 Multina Injection 22-07-2008 Dy. No.
Each ml Contains; 22293 dated
Vitamin A…15,000IU 26-06-2018
Vitamin D3…1,000IU
Vitamin E…20mg 10000/-
Vitamin B1…10mg
Vitamin B2…5mg
Vitamin B6…3mg
Nicotinamide…35mg
D-Pantothenol…25mg
Vitamin B12…5mcgc
xlvii. M/s Evergreen Pharmaceuticals (Vet. Division) 69-70 / B, Glaxo Town Industrial Estate, 20-Km F/Pur
Road, Lahore.
401. 074071 EG Supertonic Solution 07-05-2013 Dy. No. Application is submitted
Each ml contains: 20625 dated after due date but within
Vitamin E…200mg 07-06-2018 sixty days with double
Sorbitol…50mg fee as required.
Choline Chloride…50mg 20000/-
xlviii. M/s A & K Pharmaceuticals, 94-A, Punjab Small Industries Estate, Sargodha Road, Faisalabad.
402. 048217 En-Col Liquid 19-07-2008 Dy. No.
Each 100ml Contains: 21840 dated
Enrofloxacin HCl…20gm 22-06-2018
Colistin 10000/-
Sulphate…50,000,000IU
403. 048216 Enroak Liquid 19-07-2008 Dy. No.
10000/-
xlix. M/s Intervac (Pvt) Ltd., 18-KM, Lahore Sheikhupura Road, Sheikhupura
404. 048245 Enro-C Liquid 30-07-2008 Dy. No.
Colistin
Sulphate…5,000,000IU 10,000/-
405. 048246 Enrofas-C Oral Powder 30-07-2008 Dy. No.
Each 100gm Contains: 21578 dated
Enrofloxacin 19-06-2018
HCl…20,000mg
Colistin 10,000/-
Sulphate…4,500,000IU
406. 048248 Oxytet 200 Powder 30-07-2008 Dy. No.
Each Kg Contains: 21578 dated
Oxytetracyclin HCl 200gm 19-06-2018
eq. to
Oxytetracyclin…185gm 10,000/-
407. 048249 Lincol Water Soluble 02-09-2008 Dy. No.
Powder 21578 dated
Lincomycin HCl…100mg
Colistin 10,000/-
Sulfate…800,000IU
408. 048251 Leva-C Oral Suspension 30-07-2008 Dy. No.
Levamisole HCl…100mg 19-06-2018
Closantai…100mg
10,000/-
409. 048252 Intermectin Oral Solution 30-07-2008 Dy. No.
Ivermectin…1gm 19-06-2018
10,000/-
410. 048253 NCC-154 Powder 30-07-2008 Dy. No.
Each Kg Contains: 21578 dated
Colistin Sulphate…4.0gm 19-06-2018
Chlortetracycline
HCl…80.0gm 10,000/-
Neomycin
Sulphate…70.0gm
411. 048254 Novafas Liquid 30-07-2008 Dy. No.
Novaminsulfon…40mg 19-06-2018
Etilefrin…0.2mg
Calcium 10,000/-
Gluconate…110mg
Magnesium
Gluconate…10mg
Sodium Salicylate…7mg
Nicotinamide…0.3mg
Caffeine…10mg
Boric Acid…10mg
412. 048255 Neo-Oxy-E Powder 30-07-2008 Dy. No.
Erythromycin 19-06-2018
(Thiocyanate)…10gm
Neomycin Sulphate…10gm 10,000/-
413. 048256 Niclovit Powder 30-07-2008 Dy. No.
Niclosamide…40gm 19-06-2018
Levamisole HCl…10gm
Vitamin A…15,000IU 10,000/-
414. 048257 Erythrofas Plus Powder 30-07-2008 Dy. No.
Erythromycin 19-06-2018
Thiocyanate…10gm
Sulphadiazine 10,000/-
Sodium…10gm
Trimethoprim…2.0gm
Bromhexine HCl…2.50gm
415. 048258 Chlorofura-N Water 30-07-2008 Dy. No.
Soluble Powder 21578 dated
Each 100gm Contains: 19-06-2018
Chlortetracycline HCl
Vet…10gm 10,000/-
Neomycin
Sulphate…3.0gm
Furaltadone Vet…7.5gm
416. 048259 Albasol CS Suspension 30-07-2008 Dy. No.
Albendazole…2.5gm 19-06-2018
Cobalt Chloride…0.075gm
Sodium Selenite…0.035gm 10,000/-
417. 048260 Clozanide-CS Drench 30-07-2008 Dy. No.
Oxyclozanide…4.5gm 19-06-2018
Sodium Selenite…50mg 10,000/-
418. 048262 Levacol Plus Oral 30-07-2008 Dy. No.
Levamisole HCl…1.50gm
Oxyclozanide…3.0gm 10,000/-
Selenium…0.035gm
419. 048263 Oxafas CS Liquid 30-07-2008 Dy. No.
Oxfendazole…2.265gm 19-06-2018
Cobalt…0.200gm
Selenium…0.050gm 10,000/-
420. 048264 Cinafas Oral Suspension 30-07-2008 Dy. No.
Trimethoprim…2500mg 19-06-2018
Sulphamethazine…5000mg
Sulphamethoxypyridazine 10,000/-
…7500mg
Enrofloxacin…7500mg
421. 048265 Poulcocx Super Oral 30-07-2008 Dy. No.
Slulphadiazine…35.50mg
Sulphadimidine…28.4mg 10,000/-
Neomycin
Sulphate…1.8mg
Hyoscine
Methylbromide…0.04mg
Pectin…7.1mg
Kaolin…103.3mg
Vitamin B1…0.15mg
Vitamin B2…0.2mg
422. 075733 Tricla Plus Drench 19-06-2013 Dy. No.
Triclabendazole…5gm 19-06-2018
Levamisole HCl…3.75gm
10,000/-
423. 075734 Naflosol Oral Solution 19-06-2013 Dy. No.
Each 1 Liter Contains: 21578 dated
Florfenicol…230mg 19-06-2018
10,000/-
l. M/s Noa Hemis Pharmaceuticals, Plot No. 154 Sector 23 Korangi Industrial Area Karachi
424. 048204 Tylodoxin Water Soluble 17-07-2008 Dy. No.
Powder 22405 dated
Each 1000g Contains: 07-06-2018
Tylosin Tartrate…100gm
Doxycycline HCl…210gm 10000/-
li. M/s SJ&G Fazul Ellahie, Karachi
425. 048153 Enflox-20 Injection 02-07-2008 08-06-2018
Each ml contains:
Enrofloxacin…200mg 10000/-
426. 048295 Rexa-Plus Injection 31-07-2008 08-06-2018
Each ml contains:
Florefenicol…300mg 10000/-
427. 048296 Flukazole Suspension 31-07-2008 08-06-2018
8.75%
Each ml contains:
Triclabendazole…50mg 10000/-
Levamisole HCl…37.5mg
428. 048297 Flukazole Suspension 31-07-2008 08-06-2018
19.5%
Each ml contains:
Triclabendazole…120mg 10000/-
Levamisole HCl…75mg
c. Pending cases
Sr. Reg. No. Brand Name, Initial date of Date of Renewal Remarks (if any)
No. Composition Registration application validity
(R&I)
Fee
submitted
lii. M/s. Martin Dow Marker Ltd., 7, Jail Road, Quetta.
429. 017582 Pcam 10mg Capsules 13-05-1997 Dy. No. 6599 02-03-2018
Each capsule contains: dated
Piroxicam …..10mg Transfer of 21-02-2018
dated:
03-03-2008 and
21-03-2018
430. 010194 Concor Tablet 05-12-1989 Dy. No. 6522 02-03-2018
5mg dated
Each film coated tablet Transfer of 21-02-2018
contains: registration dated 10000/-
Bisoprolol 03-03-2008 and
Hemifumarate … 5mg 21-03-2018
431. 004158 Multibionta for Infusion 11-06-1978 Dy. No. 6569 02-03-2018
Each 10ml contains: dated
Vitamin A (Palmitate) Transfer of 21-02-2018
… 10,000 I.U registration dated
Vitamin B1 (Thiamine 03-03-2008 and 10000/-
HCI) … 50mg 21-03-2018
Riboflavin 5 (Phosphate
Sodium)… 10mg
Vitamin B6 (Pyridoxine
HCI)… 15mg
Nicotinamide… 100mg
Dexpanthenol … 25mg
Vitamin C (Ascorbic
Acid) …500mg
Vitamin E (dl-Alpha
Tocopheryl Acetate) …
5mg
432. 026855 Lodopin 10mg Tablet 12-05-2001 Dy. No. 02-03-2018
Each film coated tablet 6557
contain: Change of brand dated
Amlodipine Besylate eq. name dated 21-02-2018
to Amlodipine …10mg 22-01-2002
10000/-
Transfer of
registration
dated:
03-03-2008 and
21-03-2018
433. 025485 Ranulcid Tablet 300mg 17-11-1999 Dy. No. 02-03-2018
contain: Change of brand dated
Ranitidine HCl eq. to name dated 21-02-2018
Ranitidine … 300mg 15-02-2000
10000/-
Transfer of
registration dated
03-03-2008 and
21-03-2018
434. 025486 Ranulcid Tablet 150mg 17-11-1999 Dy. No. 02-03-2018
contains: Change of brand dated
Ranitidine HCl eq. to name dated 21-02-2018
Ranitidine … 150mg 15-02-2000 10000/-
Transfer of
registration
dated:
03-03-2008 and
21-03-2018
435. 007434 Sangobion Syrup 27-05-1984 Dy. No. 02-03-2018
Ferrous Gluconate … registration dated dated
129.5mg 03-03-2008 and 21-02-2018
Vitamin B1 (Thiamine 21-03-2018 10000/-
HCI) … 1mg
Vitamin B2 (Riboflavin)
… 1mg
HCI)… 1.5mg
Nicotinamide… 15mg
Biotin … 0.3mg
436. 018032 Optifam Tablet 20mg 05-10-1995 Dy. No. 02-03-2018
Each film coated tablet Change of brand 6596
contains: name dated dated
Famotidine … 20mg 04-03-1996 21-02-2018
Transfer of 10000/-
registration dated
03-03-2008 and
21-03-2018
437. 037634 Mercip Tablets 750 mg 07-03-2005 Dy. No. 02-03-2018
Each Film Coated Tablet Transfer of 6563
contains: registration dated dated
Ciprofloxacin 03-03-2008 and 21-02-2018
Hydrochloride, USP 07-06-2018 10000/-
equivalent to
438. 018040 Pcam 20mg Capsules 13-05-1997 Dy. No. 6600 02-03-2018
Each capsule contains: Transfer of dated
Piroxicam …..20mg registration dated 21-02-2018
03-03-2008 and 10000/-
21-03-2018
439. 018039 Teril 200mg Tablet 15-10-1995 Dy. No. 6625 02-03-2018
Each tablet contain: Transfer of dated
Carbamazepine … registration dated 21-02-2018
200mg 03-03-2008 and 10000/-
21-03-2018
440. 006472 Refobacin Injection 40 11-07-1982 Dy. No.
mg 6616
Each 1 ml contains: Transfer of dated
Gentamicin sulfate USP registration dated 21-02-2018
equivalent to Gentamicin 03-03-2008 and
…….40 mg 07-06-2018 10000/-
th
| 928
441. 023375 Refobacin Injection 20 19-04-1999 Dy. No.
mg 6615
Gentamicin sulfate USP registration dated 21-02-2018
equivalent to Gentamicin 03-03-2008 and
….20 mg 07-06-2018 10000/-
442. 010193 Neurofenac Capsules 05-12-1989 Dy. No.
50mg 6585
Each capsule contains: Transfer of dated
Diclofenac Sodium USP registration 21-02-2018
… 50mg dated:
03-03-2008 10000/-
Source of pellets:
M/s Inventia Healthcare Transfer of
Pvt Limited, registration
Maharashtra State, India. dated:
21-3-2018
443. 045345 Neurogabin-M Capsule 11-05-2007 Dy. No.
100mg 6591
Each capsule contains: Change of brand Dated21-02-
Gabapentin … 100mg name and 2018
transfer dated
15-03-2008 10000/-
Transfer of
registration dated
21-03-2018
300mg 6592
Change of brand dated
Each Capsule Contains: name dated 31- 21-02-2018
Gabapentin … 300mg 12-2007
10000/-
Change of brand
name and
transfer dated
15-03-2008
Transfer of
registration dated
21-03-2018
445. 025583 Lodoz Tablets 24-03-2000 Dy. No. As per batch record
Each Film coated Tablet Transfer of 6562 the firm is using
contains: registration dated dated Bisoprolol
Bisoprolol 03-03-2008 and 21-02-2018 Hemifumarate.
Hemifumarate ... 2.5 mg 07-06-2018
Hydrochlorothiazide ... 10000/-
6.25 mg
446. 001492 Polybion Forte C Tablets 15-08-1976 Dy. No.
Each Film Coated Tablet 6605
contains: Transfer of dated
Vitamin B1 (Thiamine registration 21-02-2018
Mononitrate) …..15 mg dated:
Vitamin B2 (Riboflavin) 03-03-2008 10000/-
….15 mg
Nicotinamide …. 50 Transfer of
mg, registration
Vitamin B6 (Pyridoxine dated:
Hydrochloride)… 10 mg 07-06-2018
Calcium D-
Pantothenate………25
mg
Vitamin B12
(Cyanocobalamin)
…..10 mcg
Vitamin C (Ascorbic
Acid) ……. 300 mg
447. 000719 Polybion Strong Tablets 30-11-1976 Dy. No.
Each Film coated Tablet 6609
contains: Transfer of dated
Hydrochloride)…..15 dated:
mg, 03-03-2008 10000/-
Vitamin B2
(Riboflavin)….4 mg Transfer of
Vitamin B6 (Pyridoxine registration
Hydrochloride)…… 10 dated:
mg 07-06-2018
Vitamin B12
(Cyanocobalamin)…10
mcg
Nicotinamide…..50 mg,
Calcium D-
Pentothenate….6mg
448. 017581 Pcam 20mg Tablets 13-05-1997 Dy. No.
(Dispersible) 6603
Transfer of dated
Each tablet contains: registration 21-02-2018
Piroxicam USP … dated:
20mg 03-03-2008 10000/-
Transfer of
registration
dated: 21-03-
2018
449. 001465 Bisolvon 8 mg Tablets 15-08-1976 Dy. No.
Each Tablets Contains: 6629
Bromhexine Transfer of dated
Hydrochloride ... 8mg registration 21-02-2018
dated:
03-03-2008 10000/-
Transfer of
registration
dated: 07-06-
2018
450. 024601 Mercip Tablet 250mg 21-03-2002 Dy. No.
6564
Each film coated tablet Transfer of dated
contains: registration 21-02-2018
Ciprofloxacin HCl eq. to dated:
Ciprofloxacin …250mg 03-03-2008 10000/-
Transfer of
registration
dated: 21-03-
2018
451. 020741 Sterile Water for 23-12-1997 Dy. No.
Injection 6623
Each ampoule contains: Transfer of dated
Sterile water….. 5 ml registration 21-02-2018
dated:
03-03-2008 10000/-
Transfer of
registration
dated: 07-06-
2018
452. 014786 Polybion-N-Drops 05-12-1993 Dy. No.
Each 2 ml contains: 6610
Thiamine Transfer of dated
Hydrochloride….5 mg registration 21-02-2018
Riboflavin 5’- dated:
Phosphate….2 mg 03-03-2008 10000/-
Pyridoxine
Hydrochloride…2 mg Transfer of
Biotin……… 2 mg registration
Nicotinamide…..20 mg dated: 07-06-
Dexpanthenol ….250 2018
mcg
453. 017580 Pcam 10mg Tablets 13-05-1997 Dy. No.
6602
Each dispersible tablet Transfer of dated
Piroxicam USP … dated:
10mg 03-03-2008 10000/-
Transfer of
registration
dated: 21-03-
2018
454. 025487 Ranulcid Injection 17-11-1999 Dy. No.
6611
Each 2ml contains: Change of Brand dated
Ranitidine HCI as base Name 21-02-2018
………50mg 15-02-2000
10000/-
Transfer of
registration
dated:
03-03-2008
Transfer of
registration
dated: 21-03-
2018
455. 013911 Neurofenac Injection 16-01-1993 Dy. No.
Diclofenac Sodium … Change of title dated
75mg of firm dated 03- 21-02-2018
03-2008
10000/-
Transfer of
registration
dated: 21-03-
2018
456. 004169 Polybion Forte Syrup 11-06-1978 Dy. No.
6607
Vitamin B1 (Thiamine Change of title dated
HCI) … 5mg of firm dated 03- 21-02-2018
Vitamin B6 (Pyridoxine 03-2008
HCI)… 2.5mg 10000/-
Nicotinamide … 20mg Transfer of
Riboflavin 5 (Phosphate registration
Sodium) … 2.5mg dated: 21-03-
Dexpanthenol … 3mg 2018
Vitamin B12
(Cyanocobalamin) …
3mcg
457. 048580 Psyper Tablets 4 mg 03-05-2008 Dy. No.
14426
Each Film coated Tablet dated
contains: Transfer of 18-04-2018
Risperidone………..4 registration
mg dated: 07-06- 10000/-
2018
458. 017583 Cosome Cough Syrup 10-07-1995 Dy. No.
6524
Each 5ml Contains: Transfer of dated
Dextromethorphan registration 21-02-2018
Hydrobromide…..10mg dated: 03-03-
Pseudoephedrine 2008 10000/-
Hydrochloride……30mg
Chlorpheniramine Transfer of
Maleate……2mg registration dated
21-03-2018
459. 024603 Klaribact 250mg Tablet 21-03-2002 Dy. No.
6553
Each Tablet Contains: Transfer of dated
Clarithromycin…… registration 21-02-2018
250mg dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-03-2018
460. 030010 Glucovance Tab 21-02-2003 Dy. No.
6539
250mg/1.25mg registration 21-02-2018
Metformin dated: 03-03-
Hydrochloride … 250mg 2008 10000/-
Glibenclamide ...
1.25mg Transfer of
registration dated
21-03-2018
461. 020245 Depex Capsule 14-10-1997 Dy. No.
6527
Each Capsule Contains: Transfer of dated
Fluoxetine HCI eq. to registration 21-02-2018
Fluoxetine … 20mg dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-03-2018
462. 028000 Concor Tablet 2.5mg 14-06-2002 Dy. No.
Each Tablet Contains: 6521
Bisoprolol Hemi Transfer of dated
fumarate …..2.5mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-03-2018
463. 020990 Neuromet Injection 25-04-1998 Dy. No.
Mecobalamin…..500mc registration dated
g dated: 03-03- 21-02-2018
2008
10000/-
Transfer of
registration dated
21-03-2018
464. 037355 Levomerc 500mg Tablet 23-02-2005 Dy. No.
Contains: Transfer of dated
Levofloxacin registration 21-02-2018
Hemihydrate eq. to dated: 03-03-
Levofloxacin … 500mg 2008 10000/-
Transfer of
registration dated
21-03-2018
465. 037354 Levomerc 250mg Tablet 23-02-2005 Dy. No.
Each Film Coated 6555
Levofloxacin registration 21-02-2018
Hemihydrate eq. to dated: 03-03-
Levofloxacin …250mg 2008 10000/-
Transfer of
registration dated
21-03-2018
466. 020241 Multibionta Syrup 14-10-1997 Dy. No.
Vitamin A (Palmitate) Transfer of dated
USP…….3000 I.U registration 21-02-2018
Vitamin D dated: 03-03-
(Cholecalciferol) 2008 10000/-
USP….400 I.U
Vitamin B1 (Thiamine Transfer of
Hydrochloride) USP… registration dated
1.5mg 21-3-2018
Riboflavin 5 Phosphate
sodium….... 1.2mg
HCl) USP……1mg
Vitamin B12
(cyanocobalamin)
USP… 3mcg
Vitamin C (Ascorbic
acid) USP…… 50mg
Nicotinamide USP…
10mg
467. 001501 Wintogeno Balm 25-10-1976 Dy. No.
Each 50gm Balm 6628
Methyl Salicylate … registration 21-02-2018
12.17% w/w dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-3-2018
468. 017573 Nidonil Tablet 10-07-1995 Dy. No.
6594
Gilclazide … 80mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-3-2018
469. 047263 Exigentin Syrup 24-11-2007 Dy. No.
Loratadine … 5mg Transfer of dated
registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-3-2018
470. 001062 Encephabol Liquid 23-10-1988 Dy. No.
Pyritinol Eq. to Pyritinol Transfer of dated
Hydrochloride registration 21-02-2018
Monohydrate…… dated: 03-03-
80.5mg 2008 10000/-
Transfer of
registration dated
21-3-2018
471. 027809 Merstatin Tablets 20mg 07-05-2002 Dy. No.
Each Tablet contains: 6580
Simvastatin...…20 mg Transfer of dated
dated: 03-03-
2008 10000/-
Transfer of
registration dated
07-06-2018
472. 032062 Ibusoft Gel 24-01-2004 Dy. No. Transfer letter dated
Each 1gm contains: 6551 07-06-2018 indicates
Ibuprofen ….100 mg Transfer of dated label claim:
registration 21-02-2018 Each 1gm contains:
dated: 03-03- Ibuprofen …10 mg
2008 10000/-
Transfer of
registration dated
07-06-2018
473. 047220 Cosome –E Cough 13-11-2007 Dy. No.
Syrup 6525
Ammonium Chloride … Transfer of dated
30mg registration 21-02-2018
Diphenhydramine HCI dated: 03-03-
… 8mg 2008 10000/-
Aminophylline …32mg
Transfer of
registration dated
21-3-2018
474. 024605 Klaribact Dry 21-03-2002 Dy. No.
Suspension 6552
Transfer of dated
Each 5ml Contains: registration 21-02-2018
Clarithromycin…..125m dated: 03-03-
g 2008 10000/-
Transfer of
registration dated
21-3-2018
475. 030008 Glucovance Tablet 21-02-2003 Dy. No.
500mg/5mg 6541
Transfer of dated
Each film coated tablet registration 21-02-2018
contains: dated: 03-03-
Metformin 2008 10000/-
Hydrochloride
…….500mg Transfer of
Glibenclamide ... 5mg registration dated
21-3-2018
476. 030009 Glucovance Tablet 21-02-2003 Dy. No.
500mg/2.5mg 6540
dated
Each film coated tablet 21-02-2018
contains:
Metformin 10000/-
Hydrochloride … 500mg
Glibenclamide ... 2.5mg
400mg 6593
Change of brand dated
Each Capsule Contains: name dated 31- 21-02-2018
Gabapentin…….400mg 12-2007 and 15-
03-2008 10000/-
Transfer of
registration dated
15-03-2008 and
21-3-2018
478. 010195 Concor Tablet 10mg 05-12-1989 Dy. No.
6523
Each Film Coated Tablet Transfer of dated
Contains: registration 21-02-2018
Bisoprolol dated: 03-03-
Hemifumarate … 10mg 2008 10000/-
Transfer of
registration dated
21-3-2018
479. 000552 Glucophage Tab 500mg 21-10-1987 Dy. No.
6536
Transfer of
registration dated
21-3-2018
480. 001486 Neurobion Tablet 15-08-1976 Dy. No.
6584
Vitamin B1 (Thiamine dated: 03-03-
Mononitrate) … 100mg 2008 10000/-
HCI)… 200mg Transfer of
Vitamin B12 registration dated
(Cyanocobalamin) … 21-3-2018
200mcg
481. 024604 Klaribact Tablet 500mg 21-03-2002 Dy. No.
6554
Clarithromycin … dated: 03-03-
500mg 2008 10000/-
Transfer of
registration dated
21-3-2018
482. 013365 Glucophage Tablet 25-05-1992 Dy. No.
250mg 6535
Each film coated tablet Transfer of dated
Transfer of
registration dated
21-3-2018
483. 032061 Ibusoft Suspension 24-01-2004 Dy. No.
6550
Ibuprofen .......100mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration dated
07-06-2018
484. 001063 Encephabol Tablet 14-07-1976 Dy. No.
6532
Each film coated tablet Transfer from dated
contains: import to local 4- 21-02-2018
Pyritinol 12-1986
Dihydrochloride 10000/-
Mononitrate ...100mg Transfer of
registration
dated: 03-03-
2008
Transfer of
registration dated
21-3-2018
485. 027808 Merstatin Tablets 10mg 07-05-2002 Dy. No.
6579
Each Tablet contains: Transfer of dated
Simvastatin …10 mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration dated
07-06-2018
486. 024602 Mercip Tablet 500mg 21-03-2002 Dy. No.
6565
Ciprofloxacin HCL eq. dated: 03-03-
Ciprofloxacin … 500mg 2008 10000/-
Transfer of
registration dated
21-3-2018
487. 001485 Neurobion Injection 15-08-1976 Dy. No.
6583
Each 3ml contains: Transfer of dated
HCI) … 100mg dated: 03-03-
Vitamin B6 (Pyridoxine 2008 10000/-
HCI)… 100mg
Vitamin B12 Transfer of
(Cyanocobalamin) … registration dated
1000mcg 21-3-2018
488. 047264 Exigentin Tablet 24-11-2007 Dy. No.
Loratadine …10mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-3-2018
489. 018749 Delax Tablet 03-04-1996 Dy. No.
6526
Each sugar enteric Transfer of dated
coated tablet contains: registration 21-02-2018
Bisacodyl … 5mg dated: 03-03-
2008 10000/-
Transfer of
registration dated
22-3-2018
490. 025488 Glucophage Tablet 1g 11-05-2000 Dy. No.
6590
Hydrochloride … 1g 2008 10000/-
Transfer of
registration dated
21-3-2018
491. 011875 Glucophage Tablet 29-12-1990 Dy. No.
850mg 6537
Transfer of dated
Each film coated Tablet registration 21-02-2018
Contains: dated: 03-03-
Metformin 2008 10000/-
Hydrochloride … 850mg
Transfer of
registration dated
21-3-2018
492. 020991 Neuromet Tablet 25-04-1998 Dy. No.
6590
Each Sugar Coated Transfer of dated
Tablet Contains: registration 21-02-2018
Mecobalamin…….500m dated: 03-03-
cg 2008 10000/-
Transfer of
registration dated
21-3-2018
493. 017585 Neoprox 500mg Tablet 10-07-1995 Dy. No.
6582
Each film coated Tablet Transfer of dated
Naproxen … 500mg dated: 03-03-
2008 10000/-
Transfer of
registration dated
21-3-2018
liii. M/s. Welwrd Pharmaceuticals, Plot No. 3, Block A, Phase I-II, Industrial Estate Hattar-Pakistan
494. 040344 Safbal Injection 08-04-2013 Dy. No.
Each ml Contains: Change of Brand 10390
Mecobalamine…500mc Name dated
g 20-03-2018
10000/-
495. 076811 Wrd-D Injection 08-04-2013 Dy. No.
Each 1ml Contains; 10390
Cholecalciferol…5mg dated
(200,000 IU) 20-03-2018
10000/-
496. 076812 Pyrostig Injection 08-04-2013 Dy. No.
Neostigmine…2.5mg dated
Glycopyrolate…0.5mg 20-03-2018
10000/-
497. 076813 Dexwel Tablet 08-04-2013 Dy. No.
Contains: dated
Dexibuprofen…400mg 20-03-2018
10000/-
498. 076814 Brtil Tablet 08-04-2013 Dy. No.
Bromocriptine (as dated
Mesylate)…2.5mg 20-03-2018
10000/-
499. 076815 Duloxwrd 30mg Capsule 10-04-2013 Dy. No.
Each Capsule Delayed 10390
Release Contains: dated
Enteric-Coated Pellets of 20-03-2018
Duloxetine HCl eq. to 10000/-
Duloxetine…30mg
500. 075551 Moxiwrd 400mg Tablet 24-01-2013 Dy. No. Renewal application
Each Film Coated Tablet 10390 received within sixty
Contains: dated days firm submitted
Moxifloxacin (as 20-03-2018 the differential fee.
HCl)…400mg 10000/-
Differential
fee of Rs.
10,000/-
submitted on
30-01-2019
501. 075517 Paroxiwel 20mg Tablet 04-01-2013 Dy. No. Renewal application
Each Film Coated Tablet 10390 received after sixty
Contains: dated days of expiry of
Paroxetine (as 20-03-2018 registration but fall
HCl)…20mg 30000/- under SRO 1005
(I)/2017 accordingly
firm submitted
30,000/- as the
application submitted
three month late.
502. 049373 Narbip Injection 12-07-2008 Dy. No.
Buprenorphine as dated
HCl…0.3mg 20-03-2018
10000/-
503. 049374 Nalbowin Injection 12-07-2008 Dy. No.
Nalbuphene HCl…10mg dated
20-03-2018
10000/-
504. 049375 Pintaz Injection 12-07-2008 Dy. No.
Pantazocine as dated
Lactate…30mg 20-03-2018
10000/-
505. 075518 Montiwel 4mg Sachet 04-01-2013 Dy. No. Renewal application
Each Sachet Contains: 10532 received after sixty
Montelukast (as Sodium) dated days of expiry of
Granules…4mg 21-03-2018 registration but fall
30000/- under SRO 1005
(I)/2017 accordingly
firm submitted
30,000/- as the
application submitted
three month late.
INCOMPLETE CASES
a. Locally manufactured registered drugs (Human)
Specification Registratio (R&I)
n Fee
submitted
liv. M/s. AGP Limited, B-23-C, S.I.T.E., Karachi.
506. 024881 Novafol 250mg 23-06-1999 Dy. No. As per section approval
Capsules 21874 dated letter dated 28-4-2016
Each capsule contains: Transfer of 22.6.2018 issued by Licensing
Cephradine……250mg registration 10000/- Division, the firm has not
dated 17-7- approved Cephalosporin
2008 manufacturing facility.
Further inspection of FID
dated 18-9-2017 also
indicates the same.
507. 024882 Novafol 500mg 23-06-1999 Dy. No. -do-
Capsules 21875 dated
Each capsule contains: Transfer of 22.6.2018
Cephradine……500mg registration 10000/-
dated 17-7-
2008

Each 5ml contains: Transfer of 22.6.2018
Cephradine……250mg registration 10000/-
dated 17-7-
2008

Injection (IM/IV) 21876 dated
Each vial contains: Transfer of 22.6.2018
Cephradine…..250mg registration
dated 17-7- 10000/-
2008
510. 024949 Tecadin Injection 23-06-1999 Dy. No. -do-
250mg IM/IV 21863 dated
Each vial contains: Transfer of 22-6-2008
Cefoperazone…..250m registration
g dated 17-7- 10000/-
2008
511. 018070 Kefadim 1gm Injection 24-09-1995 Dy. No. When inquired regarding
Each vial contains: Transfer of 21868 dated manufacturing facility the
Ceftazidime registration 22.6.2018 firm submitted permission
Sterile…..1.00gm dated 13- dated 15-7-2008 of contract
10-2003 10000/- manufacturing from M/s
PharmEvo Pvt Limited
Karachi for three years. The
firm also informed that they
had applied for extension in
2011 from same facility for
five years but no evidence
of approval of extension is
provided. They further
stated that product is
discontinued.
512. 018069 Kefadim 500mg 24-09-1995 Dy. No. -do-
Injection 21868 dated
Each vial contains: Transfer of 22.6.2018
Ceftazidime registration
Sterile…….500mg dated 13- 10000/-
10-2003
513. 036178 Kefadim 250mg 10-01-2005 Dy. No. When inquired regarding
Injection 21866 dated manufacturing facility the
Each vial contains: 22-6-2008 firm submitted permission
Ceftazidime dated 15-7-2008 of contract
Pentahydrate eq. to 10000/- manufacturing from M/s
Ceftazidime…..250mg PharmEvo Pvt Limited
Karachi for three years. The
firm also informed that they
had applied for extension in
2011 from same facility for
five years but no evidence
of approval of extension is
provided. They further
stated that product is
discontinued.
514. 021640 Phyllocontin 100mg 20-05-1998 Dy. No. Product was initially
Tablet 21852 dated registered with the brand
Each tablet contains: Transfer of 22.6.2018 name Phyllocontin
Aminophylline registration Continus Tablet. The
Hydrate……100mg dated 17-7- 10000/- transfer of registration also
2008 bears the same name.
However the transfer letter
dated 17-7-2008 bears only
“Phyllocontin” when the
was inquired about the
evidence of change of
brand name, they informed
that:
“The full brand name is
Phyllocontin Continus
Tablet, sometimes it is
mentioned in short form as
Phyllocontin 100mg
Tablet”
515. 016418 Nebcin Injection 80mg 21-11-1994Dy. No. Transfer of registration in
Each vial contains: 21857 dated name of M/s AGP Pvt
Tobramycin Change of 22-6-2008 Limited is not provided.
Sulphate….. 80mg brand name
dated 30-8- 10000/-
2003
516. 024951 Tecadin Injection 1gm 23-06-1999 Dy. No. As per section approval
IM/IV 21865 dated letter dated 28-4-2016
Each vial contains: Transfer of 22-6-2008 issued by Licensing
Cefoperazone…..1gm registration Division, the firm has not
dated 17-7- 10000/- approved Cephalosporin
2008 manufacturing facility.
Further inspection of FID
dated 18-9-2017 also
indicates the same.
517. 024883 Novafol Suspension 23-06-1999 Dy. No. -do-
Cephradine…..125mg Transfer of 22-6-2008
registration
dated 17-7- 10000/-
2008
518. 024880 Novafol Injection 23-06-1999 Dy. No. -do-

IM/IV 21878 dated
Cephradine…..1gm registration
dated 17-7- 10000/-
2008
519. 024950 Tecadin Injection 23-06-1999 Dy. No. -do-

500mg IM/IV 21864 dated
Cefoperazone…..500m registration
g dated 17-7- 10000/-
2008
520. 024879 Novafol Injection 23-06-1999 Dy. No. -do-

IM/IV 21877 dated
Cephradine…..500mg registration
dated 17-7- 10000/-
2008
521. 016908 Tojina 6.0mg Tablet Transfer of Dy. No. As per section approval
Each tablet contains: registration 21862 dated letter dated 28-4-2016
Bromazepam…..6mg dated: 02- 22-6-2008 issued by Licensing
07-1999 Division, the firm has not
10000/- approved psychotropic
Change of manufacturing facility.
brand name Further inspection of FID
: 30-8-2003 dated 18-9-2017 also
indicates the same.
Transfer of registration in
name of M/s AGP Pvt
Limited is not provided
522. 016907 Tojina 3.0mg Tablet Transfer of Dy. No. -do-
Each tablet contains: registration 21861 dated
Bromazepam…..3mg dated: 02- 22-6-2008
07-1999
10000/-
Change of
brand name
: 30-8-2003
lv. M/s Amson Vaccines & Pharma, 154, Industrial Triangle, Kahuta Road, Islamabad
523. 029052 Cepham 125mg 31-12-2002 Dy. No. Cephalosporin section is
Suspension 20961 dated not approved on Plot 154.
Cephalexin
Monohydrate eq. to 10000/-
Cephalexin…125mg
524. 029053 Cepham 250mg 31-12-2002 Dy. No. -do-
Cephalexin
Cephalexin…250mg
525. 029054 Cepham 250mg 31-12-2002 Dy. No. -do-
Capsule 20961 dated
Each Capsule Contains: 11-06-2018
Cephalexin
Cephalexin…250mg
526. 029055 Cepham 500mg 31-12-2002 Dy. No. -do-
Capsule 20961 dated
Each Capsule Contains: 11-06-2018
Cephalexin
Cephalexin…500mg
527. 029056 Curoxime 250mg 31-12-2002 Dy. No. -do-
Each Vial Contains: 11-06-2018
Cefuroxime Sodium eq.
to Cefuroxime…250mg 10000/-
528. 029057 Curoxime 750mg 31-12-2002 Dy. No. -do-
to Cefuroxime…750mg 10000/-
529. 029058 Curoxime 1.5g 31-12-2002 Dy. No. -do-
to Cefuroxime…1.5g 10000/-
530. 052403 Cesod 2gm IV Injection 11-09-2008 Dy. No. -do-
Each Vial Contains: 20961 dated
Ceftriaxone (as 11-06-2018
Sodium)…2gm
10000/-
531. 052404 Cesod 2gm IM 11-09-2008 Dy. No. -do-
Ceftriaxone (as
Sodium)…2gm 10000/-
lvi. M/s. Bio Fine Pharmaceuticals, 74-Industrial Estate, Multan-Pakistan
532. 30411 Tricaine Suspension 30-06-2003 Dy. No. Letter was issued to the
Each 5ml contains: 20956 dated firm regarding shortcoming
Dried Aluminum 11-06-2018 of their renewal application
Hydroxide but did not responded yet
Gel…291mg 10,000/-
Magnesium
Hydroxide…98mg
Oxethazine…10mg
533. 30412 S-Pram Tablet 30-06-2003 Dy. No. -do-
Each Tablet Contains: 20956 dated
Citalopram 11-06-2018
Hydrobromide eq. to
Citalopram…20mg 10,000/-
lvii. M/s Ferroza International Pharmaceuticals, 33-Km, Ferozpur Road, Lahore.
534. 049826 Welfam Tablet 40mg 16-07-2008 Dy. No. GMP report submitted by
Each Tablet Contains: 20737 dated the firm is 02-06-2016.
Famotidine…40mg 08-06-2018
10000/-
535. 049830 Montefer 5mg Tablet 16-07-2008 Dy. No. -do-
Each Film Coated 20737 dated
Tablet Contains: 08-06-2018
Montelukast (as 10000/-
Sodium)…5mg
536. 049831 Montefer 10mg Tablet 16-07-2008 Dy. No. -do-
Montelukast (as 10000/-
Sodium)…10mg
537. 049832 Cipromax 250mg 16-07-2008 Dy. No. -do-
Tablet 20737 dated
Each Tablet Contains: 08-06-2018
Ciprofloxacin 10000/-
HCl…250mg
538. 049833 Cipromax 500mg 16-07-2008 Dy. No. -do-
Tablet 20737 dated
Each Tablet Contains: 08-06-2018
Ciprofloxacin 10000/-
HCl…500mg
539. 049834 Sparmax 100mg Tablet 16-07-2008 Dy. No. -do-
Sparfloxacin…100mg 10000/-
540. 049835 Sparmax 200mg Tablet 16-07-2008 Dy. No. -do-
Sparfloxacin…200mg 10000/-
541. 049836 Maxzole 20mg Capsule 16-07-2008 Dy. No. -do-
Each Capsule Contains: 20737 dated
Esomeprazole as 08-06-2018
Pellets…20mg
542. 049837 Ferolax Tablet 10mg 16-07-2008 Dy. No. -do-
Escitalopram…10mg 08-06-2018
10000/-
543. 049839 D-K Tablet 75mg 16-07-2008 Dy. No. -do-
Diclofenac 08-06-2018
Potassium…75mg 10000/-
lviii. M/s. Delux Chemical Industries, LT, 26 A-1, Landhi Industrial Area, Karachi
544. 030342 Lactolac Syrup 12-06-2003 Dy. No. GMP inspection report of
Each 100ml Contains: 20732 dated 2013 is submitted by the
Lactulose…67gm 08-06-2018 firm. The firm was
requested to provide the
Source: 10,000/- latest report but again
M/s Biofac Denmark report of 2013 was
provided.
10000/- differential fee is
not submitted by the firm.
545. 030343 Rosaced Tablet 12-06-2003 Dy. No. GMP inspection report of
Each tablet contains: 20732 dated 2013 is submitted by the
Metronidazole 08-06-2018 firm. The firm was
Benzoate 321.6mg eq. requested to provide the
to 10,000/- latest report but again
Metronidazole…200mg report of 2013 was
provided.
Reference formulation i.e.

Flagyl contains
Metronidazole instead of
Metronidazole benzoate
546. 030344 Rosaced Suspension 12-06-2003 Dy. No. GMP inspection report of
Each 5ml contains: 20732 dated 2013 is submitted by the
Metronidazole 08-06-2018 firm. The firm was
Benzoate 321.6mg eq. requested to provide the
to 10,000/- latest report but again
Metronidazole…200mg report of 2013 was
provided.
547. 030345 Rosaced-Forte 12-06-2003 Dy. No. -do-
Metronidazole
Benzoate 321.6mg eq. 10,000/-
to
Metronidazole…200mg
Di-
Iodohydroquinolone…
200mg
548. 030995 Deemac Forte Tablet 21-10-2003 Dy. No. -do-
Each tablet contains: 21609 dated
Mefenamic 20-06-2018
Acid…500mg
10,000/-
549. 030996 Deenopan Tablet 21-10-2003 Dy. No. -do-
Hyoscine N- 20-06-2018
Butylbromide…10mg
10,000/-
550. 030997 Deloquin Syrup 21-10-2003 Dy. No. -do-
Each 5ml contains: 21609 dated
Chloroquine Phosphate 20-06-2018
81mg eq. to
Chloroquine 10,000/-
Base…50mg
lix. M/s Hassan Pharmaceuticals, 99-A, Industrial Estate Hayatabad, Peshawar
551. 030606 Betacef Dry 29-06-2003 Dy. No. Last renewal submitted
Suspension 22019 dated requires verification as
Each 5ml Contains: 25-06-2018 there is no statistical
Cefixime…100mg 10000/- endorsement and R&I
receiving on evidence of
renewal of 2013 provided
by the firm.
552. 030607 Betacef Capsule 400mg 29-06-2003 Dy. No. -do-
Cefixime…400mg 25-06-2018
10000/-
553. 030608 Hifenac Capsule 50mg 29-06-2003 Dy. No. Last renewal submitted
Each Capsule Contains: 22019 dated requires verification as
Diclofenac 25-06-2018 there is no statistical
Sodium…50mg 10000/- endorsement and R&I
receiving on evidence of
renewal of 2013 provided
by the firm.
Source of pellets is not

provided by the firm
lx. M/s IPP Pharma Products Manufacturer,
554. 021388 Coral-T Tablet 20-06-1998 Dy. No. Letter of shortcoming was
Each tablet contains: 21604 dated communicated to the firm,
Nifedipine…30mg 20-06-2018 however they didn’t
responded yet.
10000/-
lxi. M/s. Leads Pharma, Plot # 81-A, Street # 6, I-10/3, Islamabad
555. 035884 Leceph 125mg 10-01-2005 Dy. No. Evidence of approval pf
Suspension 21286 dated formulation in reference
Each 5ml contains: Transfer of 13-06-2018 agencies.
dated 08- 10,000/-
07-2008
556. 036303 Temerol 20mg Capsule 10-01-2005 Dy. No. 10000 fee is submitted on
Each capsule contains: 21286 dated dated 30-1-19, however the
Omeprazole…20mg Brand 13-06-2018 Source of pellets is not
name provided
change 10,000/-
dated: 24-
06-2006
Transfer of
registration
dated 25-6-
2008
557. 035891 Leazole 30mg Capsule 10-01-2005 Dy. No. 20000/- fee is submitted on
Each capsule contains: 21286 dated 30-1-2019 for the years
Lansoprazole as enteric Transfer of 13-06-2018 2013 and 2018
coated pellets…30mg registration
dated 25-6- 10,000/-
Source: M/s Smilex 2008
Laboratories Limited;
Plot No.44, CIE,
Ghandhi Naggar
Balanagar, Hyderabad -
500 037 AP India.
lxii. M/s Metro Pharmaceutical, Plot 14, Street No. SS-2, National Industrial Zone, RCCI, Rawat,
Islamabad
558. 075247 Wencin-250 Capsule 02-04-2013 Dy. No. Formulation is not
Each capsule contains: 20018 dated approved in reference
Ciprofloxacin as Hcl … 01-06-2018 agencies
250mg
20000/-
559. 75248 Wencin-500 Capsule 02-04-2013 Dy. No. Formulation is not
Ciprofloxacin as Hcl … 01-06-2018 agencies
500mg
20000/-
560. 075249 Myso-20 Capsule 02-04-2013 Dy. No. Formulation is not
Isotretinoin …. 20mg 01-06-2018 agencies
20000/-
561. 75263 Melcin-125 Dry 02-04-2013 Dy. No. Formulation is not
Suspension 20018 dated approved in reference drug
Each 5ml Contains: 01-06-2018 agencies.
Levofloxacin as
Hemihydrate…125mg 20000/-
562. 75264 Melcin-250 Dry 02-04-2013 Dy. No. Formulation is not
Levofloxacin as
Hemihydrate…250mg 20000/-
563. 75265 Wencin-125 Dry 02-04-2013 Dy. No. Formulation is not
Ciprofloxacin as Hcl …
125mg 20000/-
564. 75266 Wencin-250 Dry 02-04-2013 Dy. No. Formulation is not
Ciprofloxacin as Hcl …
250mg 20000/-
565. 75274 Mepzol 20mg Sachet 02-04-2013 Dy. No. Firm was inquired
Each sachet contains: 20018 dated regarding approval of
Omeprazole…20mg 01-06-2018 formulation in reference
agencies and they provided
20000/- the reference of formulation
containing sodium
bicarbonate.
lxiii. M/s Nawabsons Laboratories, Jia Bagga Off Raiwind Road, Lahore
566. 030320 Hemasol Syrup 30-06-2003 Dy. No. Reference formulation of
Each 5ml Contains: 20289 dated BPC is provided which is
Ferrous 05-06-2018 30g/1000ml i.e.
Sulphate…100mg 10000/- 150mg/5ml.
Ascorbic Acid…5mg Section approval is not
provided by the firm.
lxiv. M/s Nexus Pharma Pvt Limited, Plot No. 4/19 Sector 21, Korangi Industrial Area Karachi
567. 039557 Nettle Capsules 250mg 31-08-2005 Dy. No. The product initially
Each capsule contains: dated 28-06- registered in name of M/s
Cefaclor…..250mg 2018 Pride Pharmaceuticals Plot
No. 4/19 Sector 21,
10,000/- Korangi Industrial Area
Karachi. The title/ name of
the firm was changed from
aforesaid name to M/s
Nexus Pharma Pvt Limited,
Plot No. 4/19 Sector 21,
Korangi Industrial Area
Karachi vide approval
dated 22-10-2008 by
Licensing Division.
However the product was
not transferred on the new
title. It further to mention
that Brand Name of this
product was changed from
Noor Capsule 250mg to
Nettle Capsules 250mg
vide approval dated 8-11-
2008 by Registration
Division in name of M/s
Nexus Pvt Limited.
568. 039558 Nettle capsules 500mg 31-08-2005 Dy. No. The product initially
Cefaclor……500mg 2018 Pride Pharmaceuticals Plot
No. 4/19 Sector 21,
dated 22-10-2008 by
Licensing Division.
Noor Capsule 500mg to
Nettle Capsules 500mg
Nexus Pvt Limited.
569. 039561 Nitaxim 250mg 31-08-2005 Dy. No. The product initially
Injection dated 28-06- registered in name of M/s
Each vial contains: 2018 Pride Pharmaceuticals Plot
Cefotaxime (as No. 4/19 Sector 21,
Sodium)….250mg ,000/- Korangi Industrial Area
dated 22-10-2008 by
Licensing Division.
Noortax Injection to
Nitaxim Injection vide
approval dated 8-11-2008
by Registration Division in
name of M/s Nexus Pvt
Limited.
570. 039529 Flur Tablet 100mg 31-08-2005 Dy. No. The product initially
Each tablet contains: dated 28-06- registered in name of M/s
Flurbiprofen …..100mg 2018 Pride Pharmaceuticals Plot
No. 4/19 Sector 21,
,000/- Korangi Industrial Area
dated 22-10-2008 by
Licensing Division.
Purnoor Tablets to Flur
Tablet vide approval dated
8-11-2008 by Registration
Nexus Pvt Limited.
571. 039555 Nettle Suspension 31-08-2005 Dy. No. The product initially
125mg/5ml dated 28-06- registered in name of M/s
Each 5ml contains: 2018 Pride Pharmaceuticals Plot
Cefaclor…….125mg No. 4/19 Sector 21,
dated 22-10-2008 by
Licensing Division.
Noor Suspension 500mg to
Nettle Suspension 500mg
Nexus Pvt Limited.
572. 075973 Skelebenz 30mg 31-08-2005 Dy. No. Differential fee is not
Capsules dated 28-06- submitted in spite of
Each extended release 2018 requesting vide letter 23-
capsules contains: 10-2018
Cyclobenzaprine HCl 10,000/-
as extended release
pellets equivalent to
Cyclobenzaprine
HCl….30mg
(Manufacturer’s
Specification)
Source:
M/s RA Chem Pharma
Limited, Plot No. A-
19/C Road No. 18 ,
IDA , Nacharam
Hyderabad-500 076.
A.P. Hyderabad.
573. 075975 Rapitus Syrup 04-07-2013 Dy. No. References provided by the
Each ml contains: dated 28-06- firm for formulation are not
Levodropropizine…… 2018 satisfactory.
…6mg
(Manufacturer’s 10,000/-
Specification)
574. 075974 Skelebenz 15mg 04-07-2013 Dy. No. Differential fee is not
Capsule dated 28-06- submitted in spite of
Each extended release 2018 requesting vide letter 23-
capsules contains: 10-2018
Cyclobenzaprine HCl 10,000/-
as extended release
pellets equivalent to
Cyclobenzaprine
HCl….30mg
(Manufacturer’s
Specification)
Source:
M/s RA Chem Pharma
Limited, Plot No. A-
19/C Road No. 18 ,
IDA , Nacharam
Hyderabad-500 076.
A.P. Hyderabad.
575. 039563 Nitaxim Injection 1gm 31-08-2005 Dy. No. The product initially
Each powder vial dated 28-06- registered in name of M/s
contains: 2018 Pride Pharmaceuticals Plot
Cefotaxime (as No. 4/19 Sector 21,
Sodium)….1gm 10,000/- Korangi Industrial Area
dated 22-10-2008 by
Licensing Division.
Limited.
576. 039562 Nitaxim Injection 04-07-2013 Dy. No. The product initially
500mg dated 28-06- registered in name of M/s
Each powder vial 2018 Pride Pharmaceuticals Plot
contains: No. 4/19 Sector 21,
Cefotaxime (as 10,000/- Korangi Industrial Area
Sodium)……500mg Karachi. The title/ name of
dated 22-10-2008 by
Licensing Division.
Limited.
577. 039633 Coozip Capsules 20mg 24-10-2005 Dy. No. The product initially
Omeprazole…..20mg 2018 Pride Pharmaceuticals Plot
No. 4/19 Sector 21,
dated 22-10-2008 by
Licensing Division.
Shah-OM Capsules to
Coozip Capsules vide
Limited.
Source of pellets and

differential fee is not
submitted inspite of
requesting vide letter dated
23-10-2018
lxv. M/s Noa Hemis Pharmaceuticals, Plot No. 154 Sector 23 Korangi Industrial Area Karachi
578. 050479 Isogyl Capsule 21-08-2008 Dy. No. Formulation is under
Each Capsule Contains: 22159 dated review.
Isotretinoin…20mg 25-06-2018
10,000/-
579. 050492 Klarida 125mg 21-08-2008 Dy. No. Source of granules.
Clarithromycin…125m
g 10,000/-
lxvi. M/s. Panacea Pharmaceuticals, Plot # 4, Street # S-6, National Industrial Zone, Rawat, Islamabad.
580. 50163 Tasium 50mg Capsule 23-07-2008 Dy. No. Letter was issued to the
Each capsule contains: 20627 dated firm regarding shortcoming
Diclofenac Potassium 07-06-2018 of their renewal application
(as Enteric Coated but did not responded yet.
Pellets)…50mg 10,000/-
581. 50162 Fenum 50mg Capsule 23-07-2008 Dy. No. -do-
Each capsule contains: 20627 dated
Diclofenac Sodium (as 07-06-2018
Enteric Coated
Pellets)…50mg 10,000/-
lxvii. M/s Paradise Pharma, 23-KM Sheikhupura Road, Lahore
582. 076913 Pytacon Oral 25-06-2013 Dy. No. GMP inspection was
Suspension 21927 dated conducted on 06-07-2018
11-06-2018 in compliance to Drug
Each 5ml Contains: Court Lahore Order dated
Vitamin B12 10000/- 26-02-2018 by the area FID
(Cyanocobalamin)…35 concluded Firm has to
mcg improve their
documentation, SOP, and
Standard Analytical
Procedure. They are also
advised to switch on
compendia testing, do
internal audit, training of
employees, vendor
validation and qualification
of machinery/ equipment.
583. 076914 Parasolve Oral 25-06-2013 Dy. No. -do-
11-06-2018
Each 500ml Contains:
Sodium 10000/-
Chloride…1.3gm
Trisodium Citrate
Dihydrate…1.45gm
Potassium
Chloride…0.75gm
Glucose
Anhydrous…6.75gm
584. 076912 Parasmith Oral 25-06-2013 Dy. No. -do-
11-06-2018
Each 5ml Contains:
Simethicone…25mg 10000/-
Aluminum
Hydroxide…215mg
Magnesium
Hydroxide…80mg
lxviii. M/s P.D.H. Laboratories (Pvt) Ltd. 9.5-Km, Sheikhupura Road, (Khaki) Lahore
585. 030609 Lignocaine 1% 30-06-2003 Dy. No. Ampoule section not
Injection 21117 dated mentioned on revised
Contains: 12-06-2018 layout plan as approved by
Lignocaine HCl…1% 10000/- Licensing Division dated 8-
1-2019.
lxix. M/s. Qintar Pharmaceuticals, 14-A P.S.I.E, Lahore Road, Sargodha.
586. 049232 B-Fit Tablet 26-06-2008 Dy. No. Following documents are
Each Tablet Contains: 20292 dated not provided by the firm in
Fluoxetine as 05-06-, spite of requesting dated
HCl…20mg 2018 10-01-2019
a. Valid DML
10,000/- b. Latest inspection report.
587. 049231 Kepinol Forte Tablet 26-06-2008 Dy. No. -do-
Sulphamethoxazole…8 05-06-2018
00mg
Trimethoprim…160mg 10,000/-
lxx. M/s. Schazoo Zaka, Kalawala, 20-KM, Lahore-Jaranwala Road, Dist: Sheikhupura
588. 38124 Tropizol Tablet 06-05-2005 Dy. No. Letter was issued to the
Each Tablet Contains: 20445 dated firm regarding shortcoming
Pantoprazole as 06-06-2018 of their renewal application
Sodium but did not responded yet
Sesquihydrate…40mg 10,000/-
589. 46244 Zetab Plus Tablet 03-05-2007 Dy. No. -do-
Ezetimibe…10mg 06-06-2018
Atorvastatin…10mg
10,000/-
590. 20993 Zoprol Capsule 28-04-1998 Dy. No. -do-
Omeprazole…20mg 06-06-2018
10,000/-
591. 77006 Rifa-3 Tablet 24-10-2013 Dy. No. -do-
Rifampicin…150mg
Isoniazid…75mg 10,000/-
Ethambutol
HCl…275mg
592. 13082 Rifapin Dry Syrup 12-12-1991 Dy. No. -do-
Rifampicin…100mg 06-06-2018
Isoniazid…50mg
10,000/-
593. 27666 Rifazol + Tablet 07-05-2002 Dy. No. -do-
INH…75mg
Pyrazinamide…400mg 10,000/-
594. 8899 Schazobutol 400mg 19-01-1986 Dy. No. -do-
Tablet 20442 dated
Ethambutol
HCl…400mg 10,000/-
595. 27667 Schazobutol-H Tablet 07-05-2002 Dy. No. -do-
Ethambutol 06-06-2018
HCl…400mg
INH…150mg 10,000/-
596. 6946 Rifapin 450mg Tablet 10-10-1983 Dy. No. -do-
Contains: 20443 dated
10,000/-
597. 13084 Rifapin-H Dry Syrup 12-12-1991 Dy. No. -do-
Isoniazid…50mg
10,000/-
598. 44706 Rifapin-H Junior 07-11-2006 Dy. No. -do-
Sachet 20443 dated
Each Sachet Contains: 06-06-2018
Rifampicin…60mg
Isoniazid…30mg 10,000/-
599. 045990 Bone-Care 0.25mcg 12-02-2007 20-06-2018 -do-
Tablet Transfer of
Each tablet contains: registration 10000/-
Alfacalcidol…0.25mcg dated 28-
06-2008
600. 013594 Rifapin H 150 Tablet 25-07-1992 06-06-2018
Each sugar coated
tablet contains:
Rifampicin…150mg
601. 008357 Rifapin H 300 Tablet 22-10-1985 06-06-2018
Rifampicin…300mg
602. 013083 Rifapin H 450 Tablet 12-12-1991 06-06-2018
Each sugar coated
tablet contains:
Rifampicin…450mg
603. 053618 Calsup Tablet 04-12-2008 06-06-2018
Each chewable tablet
contains:
Elemental
Calcium…400mg
Vitamin D3…2.5mcg
(100U) 10000/-
604. 053619 Piofit Plus 15/850mg 04-12-2008 06-06-2018
Tablet
contains:
Pioglitazone as 10000/-
(HCl)…15mg
Metformin
HCl…850mg
605. 077005 Rifa-2 Tablet 24-10-2013 06-06-2018
contains:
Rifampicin…150mg
606. 030094 Sontel 10mg Tablet 17-03-2003 06-06-2018
Montelukast …10mg 10000/-
lxxi. M/s Searle, F-319, S.I.T.E. Karachi.
607. 004071 Tranxene 5mg Capsule 02-07-1978 Dy. No. Letter was issued to the
Contains: 22295 dated firm regarding shortcoming
Dipotassium 05-06-2018 of their renewal application
Clorazepate…5mg 10000/- but did not responded yet
608. 004072 Tranxene 10mg 02-07-1978 Dy. No. -do-
Capsule 22295 dated
Dipotassium 10000/-
Clorazepate…10mg
lxxii. M/s Spencer & Company (Pvt) Ltd. D-105, S.I.T.E., Karachi.
609. 004184 Minolad Syrup 18-06-1978 Dy. No. Letter was issued to the
Each 4ml Contains: 20287 dated firm regarding shortcoming
Vitamin A…2800IU 05-06-2018 of their renewal application
Vitamin D2…400IU 10000/- but did not responded yet
L-Lysine Mono
hydrochloride…25mg
Iron Choline
Citrate…40mg
Calcium
Glycerophosphate…20
mg
Sodium
Glycerophosphate…4m
g
Manganese
Sulphate…0.2mg
Copper
Sulphate…0.2mg
Choline
Chloride…1mg
Methionine…4mg
lxxiii. M/s Standpharm Pakistan, 20-Km, Ferozepur Road, Lahore
610. 049939 Deact Injection 1gm 17-07-2008 Dy. No. Section approval is not
Each Vial Contains: 22021 dated provided by the firm in
Cefoperazone as Change of 25-06-2018 spite of requested vide
Sodium…500mg brand letter dated 08-1-2019
Sulbactum as name: 20- 10000/-
Sodium…500mg 11-2009
611. 049940 Deact Injection 2gm 17-07-2008 Dy. No. -do-
Each Vial Contains: 22021 dated
Cefoperazone as Change of 25-06-2018
Sodium…1gm brand
Sulbactum as name: 20- 10000/-
Sodium…1gm 11-2009
612. 049941 Buten Tablet 200mg 17-07-2008 Dy. No. Firm informed that no
Each sugar coated 22021 dated evidence of approval is
tablet contains: 25-06-2018 available in reference drug
Sulbutiamine…200mg 10000/- agencies.
613. 049957 Cefidox Tablet 100mg 17-07-2008 Dy. No. Section approval is not
Each film coated tablet 22021 dated provided by the firm in
contains: 25-06-2018 spite of requested vide
Cefpodoxime as letter dated 08-1-2019
Proxetil…100mg 10000/-
614. 049959 Tromit Injection 17-07-2008 Dy. No. Firm informed that no
10mg/ml 22021 dated evidence of approval is
Each 1ml ampoule 25-06-2018 available in reference drug
contains: agencies.
Ketorolac 10000/-
Tromethamine…10mg
615. 049960 Cefidox Dry Powder 17-07-2008 Dy. No. Section approval is not
Suspension 22021 dated provided by the firm in
Each 5ml contains: 25-06-2018 spite of requested vide
Cefpodoxime as letter dated 08-01-2019
Proxetil…40mg 10000/-
616. 050266 Spical Sugar Free 28-7-2008 Dy. No. Firm informed that no
Sachet 22021 dated evidence of approval is
Each sachet contains: 25-06-2018 available in reference drug
Calcium Lactate agencies.
Gluconate…1000mg 10000/-
Vitamin C…500mg
Calcium
Carbonate…327mg
lxxiv. M/s Trison Research Laboratories Pvt Limited, 27-A Punjab Small Industrial Estate Sargodha.
617. 075429 Astadol Tablets 23-05-2013 Dy. No. 22-5-2018 Differential fee of 10000/-
Each tablet contains: 1722 dated is submitted dated 15-01-
Paracetamol……325m 13-06-2018 2019 as renewal application
g was submitted after due
Tramadol 10000 date of registration but
HCl….37.50mg within sixty days.
(Trison Specs)
lxxv. M/s. Wise Pharmaceuticals, Plot No. 3-A, Street No. S-1, RCCI Industrial Estate, Rawat,
Rawalpindi
618. 075448 Sita-Wis 50/500mg 25-06-2013 Dy. No. Letter was issued to the
Tablet 21892 dated firm regarding shortcoming
Each film coated tablet 22-06-2018 of their renewal application
contains: but did not responded yet
Sitagliptin (as 10,000/-
Phosphate)…50mg
Metformin
HCl…500mg
619. 075449 Sita-Wis 50/1000mg 25-06-2013 Dy. No. -do-
Tablet 21892 dated
contains:
Sitagliptin (as 10,000/-
Phosphate)…50mg
Metformin
HCl…1000mg
lxxvi. M/s Xenon Pharmaceuticals, 9.5-Km, Sheikhupura Road, Lahore.
620. 022358 Steron Syrup 11-09-1998 Dy. No. Product was initially
Each 5ml Contains: 21879 dated registered in name of Dawn
Prednisolone…15mg Change of 22-06-2018 Laboratories Lahore, Firm
formulation 10000/- didn’t provide the evidence
dated : 2-7- of transfer in name of
1999 Xenon Pharmaceuticals
Change of Lahore
brand name
dated 15-7-
1999
621. 014727 Zemvit Tablet 24-11-1993 Dy. No. Product was initially
Each tablet contains: 21884 dated registered in name of Dawn
Vitamin-A…4,000IU Change of 22-06-2018 Laboratories Lahore, Firm
Vitamin-D…400IU brand name didn’t provide the evidence
Vitamin-E…30IU dated 8-12- 10000/- of transfer in name of
Vitamin-C…100mg 2009 Xenon Pharmaceuticals
Folic Acid…0.8mg Lahore
Vitamin B-1…1.5mg
Vitamin B-2…1.6mg
Vitamin B-6…2.5mg
Vitamin B-12…4.0mcg
Niacinom…18.0mg
Calcium
Carbonate…600.0mg
Ferrous
Fumerate…60.0mg
Zink
Sulphate…25.0mg
lxxvii. M/s Global Pharmaceuticals, Rawat Islamabad
622. 049233 Toxirid 500mg 26-06-2008 Dy. No. Formulation is not
Injection IV 22498 dated approved in reference
Each Vial Contains: 28-06-2018 agencies.
Cefoperazone as
Sodium…250mg 10000/-
Sulbactam as
Sodium…250mg
lxxviii. M/s Sanofi-Aventis Pakistan, Plot No. 22, Korangi Industrial Area, Karachi.
623. 050372 Amaryl M SR 1mg 05-08-2008 Dy. No. Show cause notices has
Tablet 20429 dated been issued to the
Each Bi-Layered Tablet 06-06-2018 formulation
Contains:
Glimepiride…1mg 10000/-
Metformin (as
HCl)…500mg
624. 050373 Amaryl M SR 2mg 05-08-2008 Dy. No. Show cause notices has
Tablet 20430 dated been issued to the
Each Bi-Layered Tablet 06-06-2018 formulation
Contains:
Glimepiride…2mg 10000/-
Metformin (as
HCl)…500mg
lxxix. M/s. Welwrd Pharmaceuticals, Plot No. 3, Block A, Phase I-II, Industrial Estate Hattar-Pakistan
625. 049099 Welcetain Injection 20-03-2008 Dy. No. Not approved in any
Each 2ml Ampoule 10390 reference regulatory agency
Contains: dated
Paracetamol…300mg 20-03-2018
Lidocaine. HCl…20mg 10000/-
b. Imported registered drugs from reference countries (Human)

Sr. Reg. Manufacturer Brand Name, Initial date Date of Renewal Remarks (if any)
No No. as per Composition & of applicatio validity
registration Specification Registratio n (R&I)
letter n Fee
submitted
lxxx. M/s. Medipharm (Pvt) Ltd., 108 Kot Lakhpat Industrial Estate, Lahore
626. 009866 Product Ultravist-300 13-06-1988 Dy. No. The address of
License Solution for Injection 21116 manufacturer as per
Holder: or Infusion or dated 12- copy of CoPP dated
M/s Bayer Solution for Oral Use 06-2018 27-12-2017
Vital GmbH 623.4mg Iopromide provided by the
51368 (corresponding to 20,000/- firm varies from
Leverkusen 300mg bound iodine) the address as per
Germany. per 1ml solution registration letter,
Manufacturer details are as under:
as per CoPP: Bulk
Bayer Pharma Manufacturer
AG Site 13342 Packaging &
Berlin Final Release:
Germany M/s Bayer AG
Mullerstrasse 178,
13353 Berlin
Germany
Original legalized
CoPP is required as
firm has submitted
copy.
(Bulk import local
repackaging)
627. 009865 -do- Solution for Injection 13-06-1988 Dy. No. -do-
or Infusion or 21115
Solution for Oral Use dated 12-
768.86 mg Iopromide 06-2018
(corresponding to 370
mg bound iodine) per 20,000/-
1ml solution
lxxxi. M/s A. Feroz & Co., Medicine Street 1, Marriot Road, Karachi.
628. 014013 M/s IGS Ethyl Chloride 18-07-1993 Dy. No. Letter was issued to
GmbH (Anesthetic) Liquid 20290 the firm regarding
Postfach 1129, Spray Change of dated 06- shortcoming of
Im Hemmet 1, Each Tin of Aerosol manufactur 06-2018 their renewal
79664 Contains: er: 20000/- application but did
Wehr/Baden Ethyl 12-7-2008 not responded yet
Germany. Chloride…100ml
lxxxii. M/s Martin Dow Pharmaceuticals, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi.
629. 021126 M/s Teijin Bonalfa Ointment 01-08-1998 Dy. No. The firm has
Limited, 6-7 , Each gm contains: 22157 submitted legalized
Minami – Tacalcital…2mcg dated 25- CoPP vide No.
Hemmachi, 06-2018 1849 dated 19-7-
Japan 2018 on which the
20000/- strength of
Tacalcitol Hydrate
is 2.087mcg/1gm
The manufacturing
site mentioned in
CoPP is M/s Teijin
Pharma Limited,
Iwakuni
Pharmaceutical
Factory 2-1,
Kasumigaseki 3-
chome, Chiyoda-
ku, Tokyo, which is
different from the
site mentioned on
the letter. The firm
is importing the
drug from the
aforesaid new site
which also evident
from the invoice
submitted by the
firm.
Moreover the
invoice is also not
attested by DRAP.
a. Imported registered drugs from non- reference countries (Human)
Sr. Reg. Manufactur Brand Name, Initial date Date of Renewal Remarks (if any)
No No. er as per Composition & of application validity
registration Specification Registratio (R&I)
letter n Fee
submitted
lxxxiii. M/s Allied Distributors, 1st Floor 103-K Block-2, P.E.C.H.S. Shahra-e-Qauideen, Karachi.
630. 021190 Broadsaf 250mg 15-10-1998 Dy. No. Letter was issued to
IM/IV Injection 22495 dated the firm regarding
Each Vial 28-06-2018 shortcoming of their
Contains: renewal application
Ceftriaxone but did not
Sodium eq. to 20000/- responded yet
Ceftriaxone
Sodium
Base…250mg
631. 021191 Broadsaf 500mg 15-10-1998 Dy. No. -do-
IM/IV Injection 22494 dated
Each Vial 28-06-2018
Contains:
Ceftriaxone
Sodium eq. to 20000/-
Ceftriaxone
Sodium
Base…500mg
632. 021192 Broadsaf 1g 15-10-1998 Dy. No. -do-
IM/IV Injection 22496 dated
Each Vial 28-06-2018
Contains:
Ceftriaxone
Sodium eq. to 20000/-
Ceftriaxone
Sodium
Base…1g
lxxxiv. M/s. A.J. Mirza Pharma, 1st Floor, Shafi Court, Merewether Road, Civil Lines, Karachi
633. 047678 M/s Cipla Oxaliplatin for 06-08-2008 Dy. No. Following document
Limited India Injection 50mg dated 25-06- are not provided in
Each vial 2018 spite of requesting
contains: dated 23-10-2018:
Oxaliplatin Ph. 20,000/-
Eur…..50mg a. Legalized CoPP/
FSC & GMP
b. DRAP attested
invoice
634. 047680 M/s Cipla Oncobine 06-08-2008 Dy. No. -do-

Limited India 10mg/ml dated 25-06-
Injection 2018
Each ml
contains: 20,000/-
Vinorelbine
Tartrate USP
equivalent to
Vinorelbine…..1
0mg
635. 052260 M/s Cipla Decarb-200 15-11-2008 Dy. No. -do-
Limited IndiaInjection dated 25-06-
Each vial 2018
contains:
Dacarbazine 20,000/-
USP….200mg
636. 047679 M/s Cipla Oxaliplatin for 06-08-2008 Dy. No. -do-
Limited India Injection 100mg dated 25-06-
Each vial 2018
contains:
Oxaliplatin Ph. 20,000/-
Eur.100mg
637. 047681 M/s Cipla Oncobine 06-08-2008 Dy. No. -do-
Limited India 50mg/5ml dated 25-06-
Injection 2018
Each ml
contains: 20,000/-
Vinorelbine
Tartrate USP
equivalent to
Vinorelbine…..1
0mg
lxxxv. M/s Ghani Brothers, 2nd floor Karimje Building, Opp. Habib Bank Ltd. North Napier Road, Karachi
638. 072577 Manufactur Dreico 4mg 09-07-2013 Dy. No. Firm has not
er: Injection 20955 dated submitted last
M/s Instituto Each Vial 11-06-2018 import invoice and
Biologico Contains: legalized CoPP/
Contemporan Zoledronic 20000/- FSC and GMP in
eo S.A (IBC) Acid…4mg spite of requesting
Chivilcoy- dated 1-1-2019 &
Bogota 10-1-2019 instead
Benous informed that
Aires, Principle
Argentina manufacturer are on
holidays over there,
License they will resume
Holder: work in February
2019.
M/s
Laboratorio
Dosa S.A.
Giradot,
Buenos Aries
Argentina
639. 072578 -do- Solvent for 09-07-2013 Dy. No. -do-
Dreico 4mg 20955 dated
Injection 11-06-2018
20000/-
640. 072570 Manufactur Epirrubicina 09-07-2013 Dy. No. -do-
er: Dosa 10 20959 dated
M/s Lab Injection 11-06-2018
oratorios Each Vial
IMA-S.A.I.C. Contains 20000/-
Palpa Buenos (Lyophilized):
Aries Epirubicin
Argentina HCl…10mg
License
Holder:
M/s
Laboratorio
Dosa S.A.
Giradot,
Buenos Aries
Argentina
641. 072571 -do- Epirrubicina 09-07-2013 Dy. No. -do-
Dosa 50 20959 dated
Each Vial
Contains 20000/-
(Lyophilized):
Epirubicin
HCl…50mg
642. 072572 -do- Carboplatino 09-07-2013 Dy. No. -do-
Dosa 150 20959 dated
Each Vial
Contains: 20000/-
Carboplatin…15
0mg
643. 072573 -do- Nagun 10 09-07-2013 Dy. No. -do-
Each 5ml Vial 11-06-2018
contains:
Doxorubicin 20000/-
HCl…10mg
644. 072574 -do- Nagun 50 09-07-2013 Dy. No. -do-
Each 25ml Vial 11-06-2018
Contains:
Doxorubicin 20000/-
HCl…50mg
645. 072575 -do- Water for 09-07-2013 Dy. No. -do-
Injection for 20959 dated
Epirrubicina 10 11-06-2018
Dosa 5ml
20000/-
646. 072576 -do- Water for 09-07-2013 Dy. No. -do-
Injection for 20959 dated
Epirrubicina 50 11-06-2018
Dosa 25ml
20000/-
lxxxvi. M/s Global Pharmaceuticals, Plot No. 204-205, Industrial Triangle, Kahuta Road, Islamabad
647. 047665 Refron 3MIU 04-08-2008 Dy. No. Product was
Injection 22497 dated transferred in the
Each Vial 28-06-2018 name M/s Avior
Contains: 10000/- Pharma Karachi and
Recombinant is cancelled in name
Human of M/d Global
Interferon Alpha Pharma rawat vide
2b…3MIU DRAP letter dated
01-11-2016
c. Locally manufactured registered drugs (Veterinary)
Specification Registration (R&I)
Fee
submitted
lxxxvii. M/s Elko Organization, Plot No. 27 & 28, Sector 12/B, North Karachi, Industrial Area, Karachi.
648. 028600 LEOX Bolus 02-07-2003 Dy. No. Renewal of 2013 is not
Each Bolus Contains: 20016 dated submitted by the firm.
Levamisole HCl…1.125gm 04-06-2018
Oxyclozanide…2.250gm 10000/-
lxxxviii. M/s. Attabak Pharmaceutical Industries, 5-C I-10/3, Industrial Area, Islamabad
649. 075682 Oxyno Plus Water Soluble 17-06-2013 Dy. No. GMP report submitted is
Powder 21328 dated of 2016.
Oxytetracycline
HCl…200g 10,000/-
Neomycin Sulphate…200g
Colistin
Sulphate…240MIU
650. 075683 E.N.C Man Water Soluble 17-06-2013 Dy. No. Show cause has been
Powder 21396 dated issued for Amantadine
Each 100gm contain : 14-06-2018 containing formulations.
Enrofloxacin HCl…10g
Colistin Sulphate…3.5g 10,000/-
Amantadine HCl…4g
651. 075684 Enromin Oral Liquid 17-06-2013 Dy. No. Show cause has been
Each 100ml Contains: 21410 dated issued for Amantadine
Enrofloxacin…10gm 14-06-2018 containing formulations
Colistin Sulphate…3.5g
Amantadine HCl…4g 10,000/-
652. 075685 Respi Bro Oral Liquid 17-06-2013 Dy. No.
Each ml contains: 21409 dated
Doxycycline HCl…200mg 14-06-2018
Tylosin Tartrate…100mg
Colistin 10,000/-
Sulphate…500,000IU
Bromhexine HCl…5mg
653. 705686 Coflox Oral Liquid 17-06-2013 Dy. No.
Enrofloxacin…10gm 14-06-2018
Colistin Sulphate…50MIU
10,000/-
654. 075687 CRD Kill Injection 17-06-2013 Dy. No.
Tylosin Tartrate…50mg 14-06-2018
Colistin Sulphate…10mg
Dihydrostreptomycin…100 10,000/-
mg
655. 075688 Sulpha Super Injection 17-06-2013 Dy. No.
Sulfadimidine 14-06-2018
Sodium…33.30%
10,000/-
656. 075689 E-Cam Water Soluble 17-06-2013 Dy. No. Show cause has been
Powder 21392 dated issued for Amantadine
Each 100gm contain : 14-06-2018 containing formulations
Enrofloxacin HCl…10g
Colistin Sulphate…4g 10,000/-
Amantadine HCl…4.5g
657. 075690 Pulmotin Water Soluble 17-06-2013 Dy. No. Brand name change
Powder 21387 dated approval is not provided
Each 1000g Contains: 14-06-2018 which was requested
Doxycycline HCl…200g vide letter dated: 10-1-
Tylosin Tartrate…100g 10,000/- 2019
Colistin
Sulphate…480MIU
Bromhexine HCl…5g
658. 075691 Col-En 70 Liquid 17-06-2013 Dy. No.
Enrofloxacin HCl…20g 14-06-2018
Colistin Sulphate…50MIU
10,000/-
659. 075692 Dialysis Water Soluble 17-06-2013 Dy. No.
Powder 21390 dated
Furosemide…20g
Calcium Carbonate…40g 10,000/-
Sodium Chloride…35g
Magnesium Sulphate…35g
660. 075693 Coli Liquid 17-06-2013 Dy. No. Show cause has been
Each 100ml Contains: 21412 dated issued for Amantadine
Enrofloxacin…10gm 14-06-2018 containing formulations
Colistin Sulphate…3g
661. 075694 Neomycin 70% Powder 17-06-2013 Dy. No.
Each 100gm contain : 21391 dated
Neomycin Sulphate…70g 14-06-2018
10,000/-
662. 075695 Streptobak Water Soluble 17-06-2013 Dy. No. Brand name change
Powder 21384 dated approval is not provided
Each 1000g Contains: Change of 14-06-2018 which was requested
Doxycycline HCl…200g brand name vide letter dated: 10-1-
Tylosin Tartrate…100g dated: 10,000/- 2019
Dihydrostreptomycin…20g
Bromhexine HCl…5g
663. 075696 Mandox-T Powder 17-06-2013 Dy. No. Show cause has been
Each 1000g Contains: 21353 dated issued for Amantadine
Doxycycline HCl…200g 14-06-2018 containing formulations
Tylosin Tartrate…100g
664. 075697 Amantabak 10% Powder 17-06-2013 Dy. No.
Each 1000g Contains: 21382 dated
Amantadine HCl…10g 14-06-2018
10,000/-
665. 075698 Tylobrom-S Powder 17-06-2013 Dy. No.
Doxycycline HCl…200g 14-06-2018
Dihydrostreptomycin…40g 10,000/-
Bromhexine HCl…5g
666. 075699 Genta-5 Super Injection 17-06-2013 Dy. No.
Gentamycin Sulphate…5g 14-06-2018
10,000/-
667. 075700 Genta-10 Super Injection 17-06-2013 Dy. No.
Gentamycin Sulphate…10g 14-06-2018
10,000/-
668. 075701 Lincopect Injection 17-06-2013 Dy. No.
Lincomycin as HCl…50mg 14-06-2018
Spectinomycin…100mg
10,000/-
669. 075702 Cloricox Water Soluble 17-06-2013 Dy. No.
Powder 21388 dated
Each gm contains: 14-06-2018
Sulphachlorpyridazine…33
.33% 10,000/-
Vitamin K3…3mg
670. 075703 Linco Premix 1100 Powder 17-06-2013 Dy. No.
Each 100gm Powder 21389 dated
Lincomycin HCI ….
1100mg 10,000/-
671. 075704 Tyco-G Oral Liquid 17-06-2013 Dy. No.
Guaifenesin…20g 10,000/-
Aminophylline…8g
672. 075705 Brom-Mat Oral Liquid 17-06-2013 Dy. No.
Bromhexine HCl…50mg 14-06-2018
10,000/-
673. 075706 Tilmicobak Oral Liquid 17-06-2013 Dy. No.
Tilmicosin Phosphate…25g 14-06-2018
10,000/-
674. 075707 Florfenicol Oral Liquid 17-06-2013 Dy. No.
Florefenicol…250mg 14-06-2018
10,000/-
675. 075708 Enromat Oral Liquid 17-06-2013 Dy. No.
Enrofloxacin…10g 14-06-2018
10,000/-
676. 075709 Gentymat Liquid Injection 17-06-2013 Dy. No.
Tylosin Tartrate…100mg 14-06-2018
Gentamicin
Sulphate…50mg 10,000/-
677. 075710 Meloxi DS Injection 17-06-2013 Dy. No.
Meloxicam…20mg 14-06-2018
10,000/-
678. 075711 Lincomat Injection 17-06-2013 Dy. No.
Lincomycin as HCl…50mg 14-06-2018
Spectinomycin…100mg
10,000/-
679. 075712 Neo-Mix Powder 17-06-2013 Dy. No.
Oxytetracycline 14-06-2018
HCl…200gm
Neomycin Sulphate…100g 10,000/-
Erythromycin
Thiocyanate…100g
680. 075713 ESP-BAK Powder 17-06-2013 Dy. No.
Each gm contains: 21401 dated
Sulphachlorpyridazine…33 14-06-2018
.33%
10,000/-
681. 075714 Clozine-60 Water Soluble 17-06-2013 Dy. No.
Powder 21380 dated
Each gm contains: 14-06-2018
Sulphaclozine
Sodium…60% 10,000/-
682. 075715 Tylobid Powder 17-06-2013 Dy. No.
Bromhexine HCl…10g 10,000/-
683. 075716 Eryhtro-25 Powder 17-06-2013 Dy. No.
HCl…100gm
Erythromycin 10,000/-
Thiocyanate…150gm
684. 075717 Oxcinobak Powder 17-06-2013 Dy. No.
HCl…80gm
Neomycin Sulphate…70gm 10,000/-
685. 075718 TB-Dox Powder 17-06-2013 Dy. No.
Bromhexine HCl…10g 10,000/-
686. 075719 Diaprim Powder 17-06-2013 Dy. No.
Sulfadiazine Sodium…40g 14-06-2018
Trimethoprim…8g 10,000/-
687. 075720 Neostrep Powder 17-06-2013 Dy. No.
Each gm contains: 21400 dated
Neomycin Sulphate…60mg 14-06-2018
Oxytetracycline
HCl…200g 10,000/-
Streptomycin
Sulphate…20mg
688. 075721 Frusa Min Water Soluble 17-06-2013 Dy. No.
Powder 21376 dated
Furosemide…20g
Sodium Chloride…35g 10,000/-
Manganese Sulphate…1g
Calcium Carbonate…45g
689. 075722 Uritox Powder 17-06-2013 Dy. No.
Methenamine…85g 14-06-2018
Vitamin B1…700mg
Vitamin C…100mg 10,000/-
Sorbitol…5g
690. 075723 Broncoman Powder 17-06-2013 Dy. No. Show cause has been
Each 1000g Contains: 21374 dated issued for Amantadine
Doxycycline HCl…100g 14-06-2018 containing formulations
691. 075724 Bella Flush Water Soluble 17-06-2013 Dy. No.
Powder 21373 dated
Each 100gm contain : 14-06-2018
Furosemide…2g
Belladona Extract…0.2g 10,000/-
692. 075725 Hexamine Water Soluble 17-06-2013 Dy. No.
Powder 21372 dated
Each 100gm contain : 14-06-2018
Methenamine…85mg
Vitamin B1…800mg 10,000/-
Vitamin…B2…920mg
Vitamin…K3…200mg
693. 075726 Frusa Super Water Soluble 17-06-2013 Dy. No.
Powder 21386 dated
Furosemide…25g
Sodium Chloride…35g 10,000/-
Manganese Sulphate…1g
Potassium Chloride…4g
694. 075727 Flush-C Powder 17-06-2013 Dy. No.
Furosemide…20g 14-06-2018
Potassium Chloride…4g 10,000/-
Vitamin C…5g
695. 075728 Levanol Oral Liquid 19-06-2013 Dy. No.
Each Liter Contains: 21407 dated
Bithionol 14-06-2018
Sulfoxide…100gm
Levamisole HCl…15gm 10,000/-
696. 075729 Samcoc Oral Liquid 19-06-2013 Dy. No.
Sulfaquinoxaline…20gm 14-06-2018
Amprolium…30gm
10,000/-
697. 048214 Norak-20 Liquid 19-07-2008 Dy. No. Show cause notice has
Each 100ml contains: 21843 dated been issued by
Norfloxacin HCl…..20gm 22-06-2018 concerned section.
10000/-
lxxxix. M/s. Delux Chemical Industries, LT, 26 A-1, Landhi Industrial Area, Karachi
698. 029671 Flum equel 20 Oral Liquid 21-07-2003 Dy. No. GMP inspection report
Each 100ml Contains: 21609 dated submitted is of 2013.
Flemequine…20gm 20-06-2018
10,000/-
699. 029672 Reomicinia Compound 21-07-2003 Dy. No. -do-
Oral Powder 21609 dated
Tylosin…25gm
Colistin…300MIU 10,000/-
Furaltadone…75gm
700. 075611 Mantobrom Oral Liquid 17-05-2013 Dy. No. -do-
Bromhexine HCl…2% 20-06-2018
W/V
Menthol…4% 10,000/-
d. Pending Cases
Sr. Reg. No. Brand Name, Initial date of Date of Renewal Remarks (if any)
No. Composition Registration application validity
(R&I)
Fee
submitted
i. M/s. Martin Dow Marker Ltd., 7, Jail Road, Quetta ,Pakistan
701. 075906 Cosome DA Cough Syrup 08-05-2013 Dy. No. Product is not
14422 transferred in name
Each 5ml contains: dated of M/s Martin Dow
Acefylline 18-04-2018 Marker Pvt Limited
Piperazine….45mg 10000/- Quetta.
Diphenhydramine
Hydrochloride….8mg
702. 026369 Omelcid Capsule 12-09-2000 Dy. No. 6595 Product is not
Each capsule contains: dated transferred to M/s
Omeprazole.… 20mg Transfer of 21-02-2018 Martin Dow Marker
registration 10000/- Pvt Limited Quetta.
dated 03-03-
2008 Source fixation
approval is not
provided although
firm has submitted
10000/- differential
fee
703. 025583 Lodoz Tablets 24-03-2000 Dy. No. As per batch record
Each Film coated Tablet Transfer of 6562 the firm is using
contains: registration dated Bisoprolol fumarate.
Bisoprolol Hemifumarate ... dated 03-03- 21-02-2018
2.5 mg 2008 and 07-
Hydrochlorothiazide ... 06-2018 10000/-
6.25 mg
704. 007567 Refobacin Eye Drops 15-10-1984 Dy. No. Firm has not facility
6618 for manufacturing of
Each ml contains: Transfer of dated eye drops.
Gentamicin sulfate….5 mg registration 21-02-2018 The product is not
dated: transferred in name
03-03-2008 10000/- of M/s Martin Dow
Marker Limited.
Firm has also
manufactured the
product in 2017 as
per batch record
provided.
705. 001492 Polybion Forte C Tablets 15-08-1976 Dy. No. Composition of
Each Film Coated Tablet 6605 product varies from
contains: Transfer of dated the strength provided
Vitamin B1 (Thiamine registration 21-02-2018 on Form-5B
Mononitrate) …..15 mg dated:
Vitamin B2 (Riboflavin) 03-03-2008 10000/- (Sample)
….15 mg
Nicotinamide …. 50 mg, Transfer of
Vitamin B6 (Pyridoxine registration
Hydrochloride)… 10 mg dated:
Calcium D- 07-06-2018
Pantothenate………25 mg
Vitamin B12
(Cyanocobalamin) …..10
mcg
Vitamin C (Ascorbic Acid)
……. 300 mg
706. 027952 Mercepam Tablets 1.5 mg 14-06-2002 Dy. No. Firm has not
Each tablet contains: 6578 approved
Bromazepam ……1.5 mg Transfer of dated psychotropic section
registration 21-02-2018 by Licensing
dated: Division.
03-03-2008 10000/-
Transfer of
registration
dated:
07-06-2018
707. 000719 Polybion Strong Tablets 30-11-1976 Dy. No. Composition of
Each Film coated Tablet 6609 product varies from
contains: Transfer of dated the strength provided
Vitamin B1 (Thiamine registration 21-02-2018 on Form-5B
Hydrochloride)…..15 mg, dated:
Vitamin B2 03-03-2008 10000/- (Sample)
(Riboflavin)….4 mg
Vitamin B6 (Pyridoxine Transfer of
Hydrochloride)…… 10 mg registration
Vitamin B12 dated:
(Cyanocobalamin)…10 07-06-2018
mcg
Nicotinamide…..50 mg,
Calcium D-
Pentothenate….6mg
708. 033794 Osteocur-C-Effervescent 06-09-2004 Dy. No. Firm has not
Granules 6598 approved facility for
Transfer of dated manufacturing of
Each sachet of Effervescent registration 21-02-2018 sachets.
Granules contains: dated:
Calcium Lactate 03-03-2008 10000/-
Gluconate…….1000 mg,
Calcium Carbonate.… 327 Transfer of
mg registration
Ascorbic Acid....... 500 mg dated: 07-06-
2018
709. 006474 Sistalgin Injection 11-07-1982 Dy. No. Approval of

6621 formulation w.r.t
Each 2 ml contains: Transfer of dated reference agencies
Pramiverine registration 21-02-2018 provided is not
Hydrochloride….….. 2.25 dated: satisfactory.
mg 03-03-2008 10000/-
Transfer of
registration
dated: 07-06-
2018
710. 032063 Ibusoft Capsules 200mg 24-01-2004 Dy. No. Product was initially
6548 on toll manufacturing
Each soft gelatin capsule Transfer of dated by M/s Catts
contains: registration 21-02-2018 Karachi, after
Ibuprofen Micronized dated: transfer of
Powder…….200 mg 03-03-2008 10000/- registration in 2008
the separate
permission for
extension in toll is
not provided.
From the latest batch
manufacturing details
dated 3-10-2017
indicates that firm is
manufacturing the
product at its own
premises.
However the Soft
Gelatin Capsule
manufacturing
facility is not
approved by
Licensing Division
and the product is
also not transferred in
name of M/s Martin
Dow Marker Limited
Quetta.
711. 021394 Livicod Capsules 16-05-1998 Dy. No. Soft Gelatin Capsule
Each Soft Gelatin capsules 6561 manufacturing
contains: Transfer of dated facility is not
Vitamin Rich Cod registration 21-02-2018 approved by
Oil…275 mg dated: Licensing Division
Vitamin A………60,000 03-03-2008 10000/- and the product is not
I.U. transferred in name
Vitamin D……….6000 of M/s Martin Dow
I.U. Marker Limited
Vitamin E……….3.0mg Quetta.
712. 010043 Neurofenac Capsules 25 28-01-1989Dy. No. Justification of using
mg 6588 Thiamine, Pyridoxine
Transfer of dated and Cyanocobalamin
Each capsule contains: registration 21-02-2018 in formulation
Diclofenac Sodium ….25 dated: 03-03-
mg 2008 10000/-
Transfer of
registration
dated 07-06-
2018
713. 032064 Ibusoft Capsules 400mg 24-01-2004 Dy. No. Product was initially
Each soft gelatin capsule 6549 on toll manufacturing
contains: Transfer of dated by M/s Catts
Ibuprofen... 400 mg registration 21-02-2018 Karachi, after
dated: 03-03- transfer of
2008 10000/- registration in 2008
the separate
permission for
extension in toll is
not provided.
From the latest batch
manufacturing details
dated 3-10-2017
indicates that firm is
manufacturing the
product at its own
premises.
However the Soft
Gelatin Capsule
manufacturing
facility is not
approved by
Licensing Division
and the product is
also not transferred in
name of M/s Martin
Dow Marker Limited
Quetta.
714. 014342 Neurofenac Capsules 100 14-10-1993 Dy. No. Source of pellets is
mg 6587 not fixed
Transfer of dated
Each capsule contains: registration 21-02-2018
Diclofenac Sodium ….100 dated: 03-03-
mg 2008 10000/-
Transfer of
registration
dated 07-06-
2018
715. 016100 Laxoberon Tablet 21-11-1994 Dy. No. Product is not
Each Tablet Contains: 6630 transferred in name
Sodium Picosulfate … 5mg Transfer of dated of M/s Martin Dow
registration 21-02-2018 Marker Pvt Limited
dated: 03-03- Quetta
2008 10000/-
716. 032062 Ibusoft Gel 24-01-2004 Dy. No. Transfer letter dated
Each 1gm contains: 6551 07-06-2018 indicates
Ibuprofen ….100 mg Transfer of dated label claim:
registration 21-02-2018 Each 1gm contains:
dated: 03-03- Ibuprofen …10 mg
2008 10000/-
Transfer of
registration
dated 07-06-
2018
717. 019799 Laxoberon Liquid 07-08-1996 Dy. No. Product is not
Sodium Picosulfate … 5mg 6629 transferred in name
Transfer of dated of M/s Martin Dow
registration 21-02-2018 Marker Pvt Limited
dated: 03-03- Quetta
2008 10000/-
718. 024605 Klaribact Dry Suspension 21-03-2002 Dy. No. Source of granules
6552
Each 5ml Contains: Transfer of dated
Clarithromycin…..125mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration
dated 21-3-
2018
719. 017577 Azolam Tablet 0.5mg 10-07-1995 Dy. No. Firm has not
6516 approved
Each tablet contains: Transfer of dated psychotropic section
Alprazolam … 0.5mg registration 21-02-2018 form CLB.
dated: 03-03-
2008 10000/-
Transfer of
registration
dated 21-3-
2018
720. 017576 Azolam Tablet 0.25 mg 10-07-1995 Dy. No. -do-
6515
Each tablet contains: Transfer of dated
Alprazolam … 0.25mg registration 21-02-2018
dated: 03-03-
2008 10000/-
Transfer of
registration
dated 21-3-
2018
721. 017578 Azolam Tablet 1mg 10-07-1995 Dy. No. -do-
Alprazolam … 1mg Transfer of dated
dated: 03-03-
2008 10000/-
Transfer of
registration
dated 21-3-
2018
MISCELLENOUS CASES
i. Renewal application of M/s Marvi Pharmaceuticals Pvt Limited Karachi of Pain Gay
Ointment (012777)
It is submitted that M/s. Marvi Pharmaceuticals had applied for renewal of registration of year
2015 for their following product vide SRO 1005(I)/2017 dated 05th October, 2017. Details pf products are
as under:
Reg. No Brand Name & Composition Date of registration as per
Form-5B
012777 Pain Gay Ointment 15-12-1992
Each gm contains:
Methyl salicylate ……150mg
Menthol….100
The Firm was advised to submit the evidence of initial registration letter and post registration variation (if
any) for further proceeding the case. In the reply firm submitted only the evidence of renewal of year
2010, however the firm was again requested for submission of initial registration letter. The firm
informed that they were granted the registration of Pain Gay Ointment containing Methyl Salicylate
150mg + Menthol 100mg, Registration No. 012777 vide approval letter No. F.3-6/91-Reg-II (M-94) dated
04th August, 1991.Since then they are marketing this product in whole country and export to other
countries as well. Furthermore they have also taken Trade Mark Registration of their brand PainGay from
the Trade Marks Registry, Government of Pakistan Karachi.
The firm further informed d that due to ill health followed by demise of one of their Director Mr. Nadir
Fazwani, several documents were stolen or misplaced/lost which also include registration letters issued to
them by Ministry of Health. Due to the reason they fail to apply renewal within due time.
Recently Drug Regulatory Authority of Pakistan’s decision /policy vide SRO 1005(I)/2017 dated 5 th
October, 2017 regarding renewal of registration of products applied after stipulated time. Accordingly we
have applied for renewal of Pain Gay Ointment (Reg. No. 012777) along with 3 time applicable fee i.e.
Rs.30, 000/- .The firm also stated that that they had already applied for issuance of duplicate registration
letter of subject product and applied in concerned section.
It is submitted that aforementioned product is included in the formulary and according to it Pain Gay
Ointment was registered in the name of M/s. Marvi Pharmaceuticals Pvt Limited Karachi with the
Registration No.012777 and formulation is mentioned as METHYL SALICYCILATE 15gm
+MENTHOL 10gm. However initial registration date is not mentioned in the said formulary which is the
date as provided by the firm in Form 5B with renewal application.
Submitted for consideration please.
ii. Cases of typographic errors.
a. M/s Faas Pharmaceuticals Pvt Limited, F-748L S.I.T.E., Karachi
Following products of M/s Faas Pharmaceuticals Pvt Limited, F-748L S.I.T.E., Karachi were
approved for grant of renewal as indicated below in 286th meeting of Registration Board, however the
letter was not issued due to some typographic errors in composition. These correct composition is
mentioned below for consideration please.
Brand name and

Sr. Brand Name, Composition Initial date of Renewal
Reg. No. composition as per Reg. Validity
No as per minutes of M-286 Registration validity
Letter
1. 073841 Airy 10mg Tablet Airy 10mg Tablet 27-3-2013 26-3-2023 w.e.f. 27-03-
Each chewable tablet Each film coated 2018 to 26-03-
contains: tablet contains: Change of 2023.
Montelukast Montelukast brand name:
Sodium……10mg Sodium……10mg 09-01-2018
2. 073842 Des-OD 5mg Tablet Des-Eze 5mg Tablet 27-3-2013 26-3-2023 w.e.f. 27-03-
Each film coated tablet Each film coated 2018 to 26-03-
contains: tablet contains: Change of 2023.
Desloratadine…5mg Desloratadine…5mg brand name:
09-12-2014
3. 073844 Fasofenac 100mg Tablet Fasofenac 100mg 27-3-2013 26-3-2023 w.e.f. 27-03-
Each film coated tablet Tablet 2018 to 26-03-
contains: Each film coated 2023.
Moxifloxacin as Aceclofenac as
HCl…….400mg sodium….100mg
4. 073845 Fastcure 150mg Capsule Fastcure 150mg 27-3-2013 26-3-2023 w.e.f. 27-03-
Each film coated tablet Capsule 2018 to 26-03-
contains: Each capsule contains: 2023.
Iron Polymaltose Iron Polysaccharide
Complex eq. to Complex eq. to
elemental Iron...150mg elemental
Iron...150mg
5. 073846 Airy Sachet 4mg Airy Sachet 4mg 27-3-2013 26-3-2023 w.e.f. 27-03-
Each chewable tablet Each sachet contains: 2018 to 26-03-
contains: Montelukast as Change of 2023.
Montelukast as Sodium……4mg brand name:
Sodium……5mg 13-02-2018
b. M/s. Abbot Laboratories (Pakistan) Limited, Opp. Radio Pakistan Transmission Centre,
Hyderabad Road, Landhi Karachi.
Sr. Date of Decision of the Typographical
Reg. No. Brand Name
No. Reg. Board Error
1. 006709 Prothiaden Tablet 75mg 22-02-1983 w.e.f. 22-02- Inadvertently
Each tablet contains: 2018 till 21-02- wrong decision
Dosulepin HCl…..75mg 2023 has been paste.
2. 028429 Ganaton 50mg Tablet 07-02-2003 w.e.f. 07-02-
Each tablet contains: 2018 till 06-02-
Itopride HCl….50mg 2023
Submitted please.
c. Ossopan 800 Tablet (036422) of M/s AGP Limited Karachi.

M/s AGP Limited Karachi has applied for renewal of registration for the year 2015 vide SRO
1005 (I)/ 2017 dated 5-10-2017 for the following product.
Reg. No Brand Name & Composition Date of registration
036422 Ossopan 800 Tablet 15-1-2005
Ossein Mineral Complex
The product was initially registered in name of M/s Elli Lilly Gohar Pvt Limited Karachi. The
firm was asked to submit transfer letter in their name, however rather submitting they have informed that
product renewal was submitted in 2010, by M/s Elli Lilly Gohar Pvt Limited Karachi. Due to transition
phase they miss renewal of 2015. However the transfer of registration in the name of AGP Limited has
not been submitted yet.
Submitted Please.
d. M/s Rotex Pharma Pvt Limited Formerly, M/s Rotex Medica Pakistan Pvt Limited
Islamabad.
It is submitted that below mentioned products were referred by Reg-III section for confirmation
of renewal. Details are as under:
Sr. Initial date of
Reg. No. Product Name Applicatin receiving date
No. Registration
1. 068596 Acer Tablet 100mg 13-01-2010 Due date (12-01-2015)
Each Tablet Contains:- Fee of Rs.10,000/- deposited on
Aceclofenac…100mg 26-01-2015. As application received late
but within 60 days after expiry of Reg. So
remaining fee of Rs.10,000/- deposited on
dated 17-10-2018
2. 068606 Alpha-Plus Tablet -Do- Due date (12-01-2015)
0.5mcg Fee of Rs.10,000/- deposited on
Each Tablet Contains:- 26-01-2015. As application received late
Alfacalcidol…0.5mcg but within 60 days after expiry of Reg. So
dated 17-10-2018
3. 060287 Galdio 20mg Tablet 18-09-2009 Due date (17-09-2014)
Each Tablet Contains:- Fee of Rs.10,000/- deposited on 30-09-
Ebastine…20mg 2014. As application received late but
within 60 days after expiry of Reg. So
dated 17-10-2018
4. 056214 Gastrolux 20mg 17-03-2009 Due date (16-03-2014)
Capsule Fee of Rs.10,000/- deposited on 14-03-
Each Capsule 2014. As these are imported pellets, so
Contains:- differential fee of Rs.10,000/- deposited by
Esomeprazole (as the firm dated 17-10-2018
Magnesium Trihydrate
Enteric Coated
Pellets)…20mg
Source of Pellets: M/s.
Smilax Laboratories
Ltd., Plot No. 44 CIE
Gandhi Nagar,
Balanagar,
Hyderabad, India
5. 056215 Gastrolux 40mg -Do- Due date (16-03-2014)
Capsule Fee of Rs.10,000/- deposited on 14-03-
Each Capsule 2014. As these are imported pellets, so
Contains:- differential fee of Rs.10,000/- deposited by
Esomeprazole (as the firm dated 17-10-2018
Magnesium Trihydrate
Enteric Coated
Pellets)…40mg
M/s. Smilax
Laboratories Ltd.,
Plot No. 44 CIE
Gandhi Nagar,
Balanagar,
Hyderabad, India
6. 068603 Hexalor Tablet 5mg 13-01-2010 Due date (12-01-2015)
Desloratadine…5mg 2015. As application received late but
dated 17-10-2018
7. 068599 Hexalor Tablet 5mg -Do- -Do-
Each Tablet Contains:-
Desloratadine…5mg
8. 068600 Isodil Tablet 40mg -Do- -Do-
Isosorbide-
5Mononitrate…40mg
9. 060804 Kelac 10mg Tablet 26-09-2009 Due date (25-09-2014)
Ketorolac 2014. As application received late but
Tromethamine…10mg within 60 days after expiry of Reg. So
dated 17-10-2018
10. 060805 Kelac 20mg Tablet -Do- -Do-
Ketorolac
Tromethamine…20mg
11. 066519 Kemex 20mg Tablet 03-11-2010 Due date (02-11-2015)
Piroxicam (as Beta- 2015. As application received late but
Cyclodextrin)…20mg within 60 days after expiry of Reg. So
dated 17-10-2018
12. 066395 Lemoxol DS Tablet 04-10-2010 Due date (03-10-2015)
Artemether…40mg 2015. As application received late but
Lumefantrine…240mg within 60 days after expiry of Reg. So
dated 17-10-2018
13. 068604 Levitra Tablet 250mg 13-01-2010 Due date (12-01-2015)
Levetiracetam…250mg 2015. As application received late but
dated 17-10-2018
14. 068605 Levitra Tablet 500mg -Do- -Do-
Levetiracetam…500mg
15. 066520 Montero 4mg 03-11-2010 Due date (02-11-2015)
Chewable Tablet Fee of Rs.10,000/- deposited on 03-11-
Each Chewable Tablet 2015. As application received late but
Contains:- within 60 days after expiry of Reg. So
Montelukast Sodium remaining fee of Rs.10,000/- deposited on
eq. to dated 17-10-2018
Montelukast…4mg
16. 068595 Monoflox Tablet 13-01-2010 Due date (12-01-2015)
320mg Fee of Rs.10,000/- deposited on 26-01-
Each Film Coated 2015. As application received late but
Tablet Contains:- within 60 days after expiry of Reg. So
Gemifloxacin (as remaining fee of Rs.10,000/- deposited on
Mesylate)…320mg dated 17-10-2018
17. 068609 Mebetex Tablet 135mg -Do- -Do-
Mebeverine
Hydrochloride…135mg
18. 056213 Opagis 30mg Capsule 17-03-2009 Due date (16-03-2014)
Each Capsule Fee of Rs.10,000/- deposited on 14-03-
Contains:- 2014. As these are imported pellets, so
Lansoprazole differential fee of Rs.10,000/- deposited by
(Pellets)…30mg the firm dated 17-10-2018
Source of Pellets:
M/s. Smilax
Laboratories Ltd.,
Plot No. 44 CIE
Gandhi Nagar,
Balanagar,
Hyderabad, India
19. 068601 Prada Tablet 50mg 13-01-2010 Due date (12-01-2015)
Itopride 2015. As application received late but
Hydrochloride…50mg within 60 days after expiry of Reg. So
dated 17-10-2018
20. 066396 Rotamox 400mg Tablet 04-10-2010 Due date (03-10-2015)
Moxifloxacin (as 2015. As application received late but
Hydrochloride)…400m within 60 days after expiry of Reg. So
g remaining fee of Rs.10,000/- deposited on
dated 17-10-2018
21. 056932 Timezol 20mg Capsule 29-07-2009 Due date (28-07-2014)
Omeprazole (as Enteric remaining fee of Rs.10,000/- deposited by
Coated Pellets)…20mg firm on dated 17-10-2018
Source of Pellets:
M/s. Smilax
Laboratories Ltd.,
Plot No. 44 CIE
Gandhi Nagar,
Balanagar,
Hyderabad, India
22. 056216 Timezol 40mg Capsule 17-03-2009 Due date (16-03-2014)
Omeprazole (as Enteric remaining fee of Rs.10,000/- deposited by
Coated Pellets)…40mg firm on dated 17-10-2018.
Source of Pellets:
M/s. Smilax
Laboratories Ltd.,
Plot No. 44 CIE
Gandhi Nagar,
Balanagar,
Hyderabad, India
23. 066516 Torivas 10mg Tablet 03-11-2010 Due date (02-11-2015)
Atorvastatin (as 2015. As application received late but
Calcium within 60 days after expiry of Reg. So
Trihydrate)…10mg remaining fee of Rs.10,000/- deposited on
dated 17-10-2018
24. 066517 Torivas 20mg Tablet -Do- -Do-
Atorvastatin (as
Calcium
Trihydrate)…20mg
25. 066518 Torivas 40mg Tablet -Do- -Do-
Atorvastatin (as
Calcium
Trihydrate)…40mg
26. 069871 Zepril Capsule 60mg 07-04-2011 Due date (06-04-2016)
Duloxetine as remaining fee of Rs.10,000/- deposited by
Hydrochloride firm on dated 17-10-2018
(Pellets)…60mg
Source of Pellets:
M/s. Alphamed
Formulation (Pvt.)
Ltd., Survey No. 225,
Sampanbole Village
Shamirpet Mandal,
Ranga Reddu District
500078, A.P. India
Submitted please
LEFTOVER AGENDA OF 287TH MEETING OF REGISTRATION BOARD
Case No. 1 Renewal applications of local manufacturers evaluated as per SOP approved by
Registration Board.
I II III IV V VI VII
Application
Sr. Initial date of
Reg. No. Product Name Due date receiving Remarks
No. Registration
date
1- M/s. S.J&G Fazul Ellahi (Pvt) Ltd . E/46 S.I.T.E ,Karachi
1 000821-Ex Glitacin Tab 250mg 09-02-2008 24-01-2018 08-02-2018 Correction in
Each tablet contains formulation as it is
Levofloxacin available in Film
hemihydrate Coated Tablets
eq.to,levofloxacin…….25
0mg
2 000820-EX Glitacin Tab 500mg 09-02-2008 do do Correction in
Each tablet contains formulation as it is
Levofloxacin available in Film
hemihydrate Coated Tablets
eq.to,levofloxacin…….50
0mg
3 000819-EX Korel Chewable Tab do Do
Each chewable tablet 09-02-2008
contains
Iron III Hydroxide
Polymaltose
Complex…100mg
Folic Acid….0.35mg
4 048441 Otek tab 20mg 04-02-2008 03-02-2018 24-01-2018
Each tablet contains
Piroxicam Beta –
Cyclodextrin eq.to
Piroxicam…..20mg
5 048530 Ceftizoxime….250mg 08-03-2008 07-03-2018 24-01-2018 .
Grafro Inj 250mg
Each vial contains
Ceftizoxime sodium eq.to
6 048531 Ceftizoxime….500mg 08-03-2008 07-03-2018 24-01-2018 .
Grafro Inj 500mg
Each vial contains
Ceftizoxime sodium eq.to
7 Erdozet Capsule: 28-02-2013 27-02-2018 24-01-2018
073809 Each capsule contains :
Erdosteine…..150mg
073810 Erdozet Capsule: Do do Do

Each capsule contains :
Erdosteine…..175mg
8 030013 Cefprox Tablet 100mg 12-03-2003 11-03-2018 15-02-2018 Firm submitted that
Each tablet contains product is available
Cefpodoxime proxetil in UK
eq.to Cefpodoxime
….100mg
9 030015 Cefprox Susp 12-03-2003 Do Do Do
Each 5ml contains
Cefpodoxime proxetil
eq.to Cefpodoxime
….40mg
10 073850 Cinoflox Oral Suspension 27-03-2013 26-03-2018 Do i-firm has mentioned
250mg/5ml the active ingredient
Each 5ml contains : as taste masked
Ciprofloxacin HCl eq.to pellets 35%
Ciprofloxacin…250mg ii-solvent for oral
suspension is
SOYA LECITHIN,
detail is not
11 073851 Cinoflox DS Oral DO DO DO i- i-firm has
Suspension 250mg/5ml mentioned the active
Each 5ml contains : ingredient as taste
Ciprofloxacin HCl eq.to masked pellets 35%
Ciprofloxacin…250mg ii-solvent for oral
suspension is
SOYA LECITHIN,
detail is not
12 O73852 Hidrofax Tab do do do
Each film coated tablet Xifaxan
contains:
Rifaximin…..550mg
2- M/s Platinum Pharmaceutical (Pvt)Ltd,A-20 North Western Industrial Zone .Bin Qasim Karachi
13 048537 Gerdpill 20mg Capsule 10-03-2008 09-03-2018 20-02-2018 Imported from Lee
Each capsule contains: Pharma Limited
Enteric Coated pellets of Hyderabad, India
Esomeprazole Mg Differential fee of
Trihydrate eq.to Rs10,000 is paid on
Esomeprazole …20mg 07-11-2018
ii FDA approved
14 048538 Gerdpill 40mg Capsule Do Do Do i-Imported from Lee

Each capsule contains: Pharma Limited
Enteric Coated pellets of Hyderabad, India
Esomeprazole Mg Differential fee of
Trihydrate eq.to Rs10,000 is paid on
Esomeprazole …40mg 07-11-2018
ii FDA approved
15 020175 Protect Tab 80mg 07-10-1997 24-03-2018 do TGA
Each tablet contains change of
Gliclazide …..80mg brand name
25-03-1998
16 075960 Carbex 100mg/5mlsyrup 30-03-2013 29-03-2018 do
Each 5ml contains change of
Carbocisteine……100mg brand name
05-12-2013
17 075961 Carbex 250mg`/5ml 30-03-2013 do do
syrup change of
Each 5ml contains brand name
Carbocisteine…….250m 05-12-2013
g
18 075962 Carbex 375mg 30-03-2013 do do
Each capsule contains change of
Carbocisteine…….250m brand name
g 05-12-2013
19 075963 Carbex plus syrup 30-03-2013 do
Each 5ml contains change of
Carbocisteine…….100m brand name
g 05-12-2013
Promethazine
HCL…2.5mg
3- M/s Platinum Pharmaceutical (Pvt)Ltd,A-20 North Western Industrial Zone .Bin Qasim Karachi
20 020857 Hi-Salz Toothpaste 08-01-1998 07-01-2018 do OTC
Contains: (JAPANESE
Sodium Chloride…..16% MARKET) as
Tranexamic provided by the firm
Acid….0.05%
21 047456 Easair 6mcg Inhalation 24-01-2008 23-01-2018 do Atimose Modulite
Solution (Chiesi)
Each metered dose
contains
Formoterol Fumerate
Dehydrate…….6mcg
4- M/s English Pharmaceutical Industries, Link Qatarbund Road,Thokar Niaz Baig ,Multan Road
Lahore
22 029014 Cipronag Tablet 250 mg 26-12-2002 25-12-2017 22-12-2017 eMC
Each tablet contains : Change of Aailable as film
Ciprofloxacin brand name as coated tab
HCl..250mg cipronag
31-03-2003
23 029015 Cipronag Tablet 500 mg Do do do Do
Each tablet contains :
Ciprofloxacin
HCl..500mg
24 074237 Pantakure 40mg Injection 27-12-2012 26-12-2012 do Do

Each vial contains :
Pantoprazole Sodium
monohydrate eq.to
Pantoprazole
base…40mg
25 074238 Engsol Injection Do do do eMC

0.09%w/v
Each ampoule contains:
Sodium
Chloride0…..0.9%
(10 ml ampoule)
26 074239 Engsol Injection Do do do eMC
0.09%w/v
Each ampoule contains:
Sodium
Chloride0…..0.9%
(05 ml ampoule)
27 074240 Vancotic 1gm Injection Do do Do Do
Vancomycin HCl eq.to
Vancomycin……1gm
28 074241 Vancotic 500mg Injection Do do do Do
Vancomycin HCl eq.to
Vancomycin……500mg
29 074242 Enmox 500mg injection Do do do Do
Amoxicillin Sodium
eq.to.
Amoxicillin….500mg
30 074243 Amo-Clav1.2gm Do do do Do
Injection
Amoxicillin Sodium
eq.to.
Clavulanic
Acid….200mg
31 074244 Amo-Clav 600mg

Injection
Amoxicillin Sodium
eq.to.
Clavulanic
Acid….100mg
32 074245 Cilliclox 500mg Injection Do do do Do
Amoxicillin Sodium
eq.to.
Cloxacillin Sodium eq.to.
Cloxacillin….250mg
33 074246 Cilliclox 500mg Injection Do do do Do
Amoxicillin Sodium
eq.to.
Cloxacillin Sodium eq.to.
Cloxacillin….125mg
5- M/s Selmore Pharmaceuticals(Pvt) Ltd, 36-Km Multan Road,Lahore
34 029610 Imipro Injection 24/01/2003 23/01/2018 Ok (vet)
Each ml contains :
Imiidocarb Dipropionate
USP…….120mg
6- M/s Amros Pharmaceutical A-96,S.I.T.E, North Karachi
35 020795 Sulphadimidine Inj 20-01-1998 19-01-2018 23/01/2018 Application for
Each 100ml contains: Renewal letter renewal for Vet.
Sulphadimidine….33.3g till Drugs received
20-01-2013 within 60 days with
prescribe fee of Rs.
20,000/
36 020796 Water for inj 20-01-1998 19-01-2018 23/01/2018 Application for
Each vial contains: Renewal letter renewal for Vet.
Water for injection till Drugs received
…50ml 20-01-2013 within 60 days with
prescribe fee of Rs
20,000
37 020797 Gentamycin 40mg inj Do do do Application for
Each ml contains renewal for Vet.
Gentamycin Sulphate Drugs received
eq.to Gentamycin base within 60 days with
…..40mg prescribed fee of Rs
20,000
38 020798 Oxytocin injection Do do do Application for
Each ml contains: renewal for Vet.
Oxytocin……10 I.U Drugs received
within 60 days with
prescribe fee of Rs
20,000
7- M/s Sami Pharmaceuticals (Pvt) Ltd,F-95 SITE ,Karachi
39 036350 N0voteph Capsules 31-12-2004 30-12-2014 03-12-2014 Imported pellets

40mg with Rs/10,000 on
Each capsule contains: 03-12-2004 &
Enteric Coated pellets of remaining fee of Rs
Esomeprazole Mg 10,000 on 05-11-
Trihydrate eq.to 2018
Esomeprazole (prepared
pellets)…40mg
40 045400 N0voteph Capsules 14-06-2007 13-06-2017 13-06-2017 Imported pellets
20mg with Rs/10,0000n
Each capsule contains: 13-06-2017 from
Enteric Coated pellets of M/S M.J
Esomeprazole Mg Chempharma
Trihydrate eq.to Private limited
Esomeprazole …20mg ,Gujrat ,India
Differential fee 0f
Rs 10,000was paid
on
05-11-2018
8- Hamaz Pharmaceutical (Pvt) Ltd,13-Km Boson Road,Multan
41 021321 Mazaclox Drops 15/05/1998 14/05/2018 09/05/2018 FDA
Each 0.6ml contains:
Ampicillin Trihydrate eq.
to Ampicillin Base ….
60mg Cloxacillin
Sodium eq. to Cloxacillin
Base …. 30mg
42 021322 Indocap Cap 15/05/1998 14/05/2018 09/05/2018 FDA
Indomethacin …. 25mg
43 021323 Skymox Drops 10ml 15/05/1998 14/05/2018 09/05/2018 FDA
Amoxicillin Trihydrate
eq. to Amoxicillin Base
…. 125mg
44 021324 Skymox Forte Syp 15/05/1998 14/05/2018 09/05/2018 FDA
Each 5ml contains:
Amoxicillin Trihydrate
eq. to Amoxicillin Base
…. 250mg
45 021325 Tetramaz Cap 250mg 15/05/1998 14/05/2018 09/05/2018 FDA
Oxytetracycline HCI ….
250mg
46 021326 Cedox Cap 100mg 15/05/1998 14/05/2018 09/05/2018 FDA

Doxycycline as Hyclate
…. 100mg
47 021327 Erytab Tab 500mg 15/05/1998 14/05/2018 09/05/2018 Tab is available
Each tablet contains: as
Erythromycin Estolate eq. Erythromycin
to Erythromycin …. stearate in FDA
500mg
48 021328 Estadol Susp 15/05/1998 14/05/2018 09/05/2018 FDA
Each 5ml contains:
Paracetamol …. 120mg
49 021329 Estadol Extra Tab 15/05/1998 14/05/2018 09/05/2018 NOT
Each tablet contains: PROVIDED
Caffeine …. 65mg
50 021330 Cloprel Tab 10mg 15/05/1998 14/05/2018 09/05/2018 FDA
Metoclopramide HCI ….
10mg
51 021332 Phenichlore Susp 15/05/1998 14/05/2018 09/05/2018 NOT
Each 5ml contains: PROVIDED
Chloramphenicol
Palmitate as
Chloramphenicol base ….
125mg
52 021333 Mazatrim Susp 15/05/1998 14/05/2018 09/05/2018 FDA
Each 5ml contains:
Trimethoprim …. 40mg
Sulphamethoxazole ...
200mg
53 021334 Hamadar Tab 15/05/1998 14/05/2018 09/05/2018 FDA
Sulphadoxine
(Sulphanelamide) ….
500mg
Pyremethamine …. 25mg
54 021335 Ampimaz Syp 15/05/1998 14/05/2018 09/05/2018 FDA
Each 5ml contains:
Ampicillin Trihydrate eq.
to Ampicllin base ….
125mg
55 048994 Lavenda Tab 500mg 21/02/2008 20/02/2018 17/01/2018 FDA
Clotrimazole …. 500mg
56 048995 Carducin Tab 2mg 21/02/2008 20/02/2018 17/01/2018 FDA
Doxazosin Mesylate ….
2mg
57 048920 Cloprel Drops 20ml 04/02/2008 03/02/2018 17/01/2018 FDA
Each 5ml contains:
Metoclopramide HCI eq.
to Meoclopramide ….
5mg
58 048921 Cloprel Syrup 50ml 04/02/2008 03/02/2018 17/01/2018 FDA
Each 5ml contains:
Metoclopramide HCI eq.
to Meoclopramide ….
5mg
59 048922 Estadol Plus Susp 60ml 04/02/2008 03/02/2018 17/01/2018 FDA
Each 5ml contains:
60 048923 Estadol Drops 15ml 04/02/2008 03/02/2018 17/01/2018 FDA
61 050225 Artefrost Tab 140mg 24/07/2008 23/07/2018 02/07/2018 FDA
Artemether …. 20mg
Lumefantrine …. 120mg
9- M/s. Mass Pharma(Private )limited,17 km Ferozpur Road,Lahore
62 076869 Amodip-V TABLET 5/80 29-05-2013 28-05-2018 25-05-2018 eMC
mg
Amlodipine (as
besylate)..5mg
Valsartan…….80mg
63 076870 Amodip-V TABLET 29-05-2013 28-05-2018 25-05-2018 eMC
5/160 mg
Amlodipine (as
besylate)..5mg
64 076871 Amodip-V TABLET 29-05-2013 28-05-2018 25-05-2018 eMC
10/160 mg
Amlodipine (as
besylate)..5mg
65 076872 Vensonor tablet 10mg 29-05-2013 28-05-2018 25-05-2018 Film coated tab
Each tablet contains : eMC
Rosuvastatin(as
Calcium)…10mg
66 076873 Vensonor tablet 10mg 29-05-2013 28-05-2018 25-05-2018 Film coated tab
Each tablet contains : eMC
Rosuvastatin(as
Calcium)…5mg
67 076874 Defumide Tablets 29-05-2013 28-05-2018 25-05-2018 MAHRA
Each tablet contains: (AS film coated
Leflunomide…10mg tablets)
68 076874 Defumide Tablets 28-05-2018 28-05-2018 25-05-2018 MAHRA
Each tablet contains: (AS film coated
Leflunomide…20mg tablets)
10- M/s Barret Hodgson Pakistan (Private)Ltd,F/423 SITE ,Karachi,
69 075856 Boonest 150mg tablet 11-04-2013 10-04-2018 Dy.no 2904
Ibandronate sodium
monohydrate eq.to
Ibandronic
acid…..150mg
70 075857 Inoquin125mg/5ml Dry do do Do i-firm has
Suspension mentioned the
Each 5ml contains HCl active ingredient
eq.to as taste masked
Ciprofloxacin……125mg pellets 35%
ii-solvent for
oral suspension
is SOYA
LECITHIN,
detail is not
provided by the
firm
71 075858 Inoquin250mg/5ml Dry do do Do i-firm has
Suspension mentioned the
Each 5ml contains HCl active ingredient
eq.to as taste masked
Ciprofloxacin……250mg pellets 35%
ii-solvent for
oral suspension
is SOYA
LECITHIN,
detail is not
provided by the
firm
72 075859 Barilol 2.5mg Tablet do do do
Bisoprolol
fumarate…..2.5mg
73 075860 Barilol 5mg Tablet do do do
Bisoprolol
fumarate…..5mg
74 075861 Barilol 5mg Tablet do do do
Bisoprolol
fumarate…..5mg
75 075862 Barinep Ophthalmic do do do
Suspension
Each ml contains :
Nepafenac ……..1mg
11- Nexus Pharma (Pvt) Limited .Plot No.4/19,Sector21, Korangi Industrial Area Karachi
76 075837 Avogel-C Gel 03-04-2013 02-04-2018 Dy.no2488
Each gm contains: Change of 18-01-2018
Metronidazole…….1.0% brand name Reply received
Chlorhexidine 07-08-2013 via dy.no2300
Gluconate……….0.25% 03-07-2018
77 075890 Dentisept Mouthwash 06-05-2013 05-05-2018 Dy.no6085 Me too status
Each ml contains : 18-01-2018 by
Benzydamine Reply received Zydine by
Hydrochloride….0.15%w via dy.no2346 Sante (pvt)
/v 03-07-2018 limited.
Chlorhexidine
Gluconate……….0.2%w/
v
78 O75835 Dimisinex tablet 03-04-2013 02-04-2018 Dy.no.2487 Emc( as film
Each tablet contains: 18-01-2018 coated tablets)
Dihydrartemisinin 40mg Reply received
Piperaquuinine 320mg via dy.no23217
03-07-2018
79 075832 Budex DS Suspension 03-04-2013 Dy.no.2487 MHRA
200mg/5ml 18-01-2018
Each 5ml contains: Reply received
Ibuprofen…..200mg via dy.no23217
03-07-2018
80 075836 Fosfonex 03-04-2013 02-04-2018 Dy.no.2486
Suspension250mg/5ml 18-01-2018
Each 5ml contains: Reply received
Fosfomycin as via dy.no23218
calcium…250mg 03-07-2018
12- Reko Pharmacal(Pvt) Ltd ,13Km Multan Road ,Lahore
81 029757 Ophdic eye Drops 19-03-2003 18-03-2018 Dy.no.7703 Ok
Each 5ml contains : 28-02-2018
Diclofenac Reply received
Sodium….5.25mg on dy.no.22289
26.06.2018
82 029758 Tobcin eye drops 19-03-2003 18-03-2018 Dy.no.7703 0k
Tobramycin(as Reply received
Sulphate)……15mg on dy.no.22289
26.06.2018
83 005640 Itracon 100mg Capsule 25-04-1998 24-04-2018 Dy.no.7703 Ok
Itraconazole …….100mg Reply received
on dy.no.22289
26.06.2018
84 005839 Rakitac D.S 300mg 25-04-1998 24-04-2018 Dy.no.7703 Ok
Tablets: 28-02-2018
Each tablets contains: Reply received
Ranitidine (as on dy.no.22289
HCl)…..300mg 26.06.2018
85 005840 Pirox 20mg tablets 25-04-1998 24-04-2018 Dy.no.7703 Ok
Piroxicam……20mg Reply received
on dy.no.22289
26.06.2018
13- M/s Epla Laboratories(Pvt)Ltd .D-12 Estate SITE,Karachi
86 030029 Eplacin CF tablets 01-04-2003 31-03-2018 Dy no.5835 Ok
Each tablet contains 16-02-2018
Acetaminophen…..325m
g
Chlorpheniramine
Maleate…1mg
Dextromethorphan
HBr…10mg
Pseudoephedrine
HCl…36mg
88 048565 Eplalev 500mg tablets 31-03-2008 30-03-2018 Dy.no.1809 FDA
Each film coated tablets Dated
contains: 12-01-2018
Levofloxacin (as
Hemihydrate)…500mg
89 048564 Eplalev 500mg tablets 31-03-2008 30-03-2018 Dy.no.1812 FDA
Each film coated tablets Dated
contains: 12-01-2018
Levofloxacin (as
Hemihydrate)…250mg
90 048563 Omxiclav Suspension 31-03-2008 30-03-2018 Dy.no.1814 FDA
Each 5ml contains: Dated
Amoxicillin (as 12-01-2018
amoxicillin
trihydrate)….125mg
Clavulanic Acid(as
Potassium
salt)…….31.25mg
91 029628 CR-100 Powder VET DRUG
Each kg contains
Chlortetracycline HCl
..40gm
Neomycin base (as
Sulphate)…12gm
Furaltadone(as
HCl)…30gm
14- M/s Stanely Pharmaceuticals (Pvt) Ltneomycind,84-B Industrial Estate,Hyatabad ,Peshawar
92 029780 Senam Dry Suspension 12-03-2003 11-03-2018 Dy.no.3114
Cefixime …….100mg
93 029781 Senam DS Dry 12-03-2003 11-03-2018 Dy.no.3114
Suspension 23-01-2018
Each 5ml contains :
Cefixime …….200mg
15- M/s W.Woodward Pakistan (Pvt) Ltd, F-275,S.I.T.E, Karachi
94 048614 Dermy Cream 2% 28-05-2008 27-05-2018 Dy.no 7692
Each gram contains : 28-02-2018
Fusidic acid ……20gm
16- M/s Tabros Pharma (Pvt)Ltd ,L-20/B Sector 22,F.B, Industrial Area ,Karachi
95 030011 Lexicon 7.5mg tablets 26-03-2003 25-03-2018 Dy.no.1892 UK
Meloxicam……..7.5mg Reply submitted
on
Dy.no16559
04-05-2018
96 030012 Lexicon 15mg tablets 26-03-2003 25-03-2018 Dy.no.1893 UK
Meloxicam……..15mg Reply submitted
on
Dy.no16559
04-05-2018
97 073849 Metliptin 50/850mg tab 27-03-2013 26-03-2018 Dy.no.1894 UK
contains : Reply submitted
Vildagliptin…..50mg on
Metformin Dy.no16559
HCl……850mg 04-05-2018
17- M/s Fozan Pharmaceuticals Industries (Pvt) Ltd, 36-A Industrial Estate,Hyatabad.Peshawar
98 048060 Ventisol Syrup 15-01-2008 14-01-2018 Dy.no 776 FDA
Ketotifen as Hydrogen 05-01-2018
Fumarate ….1mg
99 048365 Fozin Syrup 30-01-2008 29-01-2018 Dy.no 775 FDA
Cetrizine 2HCl….5mg
100 048061 Lor Syrup 15-01-2008 14-01-2018 Dy.no 774 FDA

Loratidine USP….5mg
18- M/s. Usawa Pharmaceuticals, 146-S.I.Z, Risalpur, Nowshera.
101 029777 Farzin Tablet 18-03-2003 17-03-2018 Dy.no. 9709
Loratadine … 10mg Reply submitted
on Dy.no.
33036 04-10-
2018
102 029778 Loporide Tablet 18-03-2003 17-03-2018 Dy.no. 9709
Enalapril Maleate … Reply submitted
10mg on Dy.no.
33036 04-10-
2018
103 029779 Firax Tablet 18-03-2003 17-03-2018 Dy.no. 9709
Cetirizine 2HCl … 10mg Reply submitted
on Dy.no.
33036 04-10-
2018
19- M/s. Geofman Pharmaceuticals, 20/23, Korangi Industrial Area, Karachi.
104 009317 Betacin Ointment 16-03-1988 15-03-2018 Dy.no. 4408 06-
Contains:- 02-2018
Betamethasone 17- Reply submitted
Valerate … 0.1% on Dy.no.
29745 05-09-
2018
Registration
letter was issued
on the address
of head office.
20- M/s. Treat Pharmaceuticals (Pvt) Ltd., A-37, Small Industrial Estate, Township, Kohat Road, Bannu.
105 075540 Treatagen Injection 07-01-2013 06-01-2018 Dy.no. 7721 28-
Each 2ml ampoule 02-2018
contains:- Application
Gentamicin (as Sulphate) received within
… 80mg 60 days after
expiry with
prescribed fee.
Reply submitted
on Dy.no. 803
16-10-2018
106 075538 Fev-Treat Injection Do Do Do
Each 2ml contains:-
Paracetamol … 300mg
Lidocaine … 20mg
21- M/s. Global Pharmaceuticals (Pvt) Ltd., Plot No. 204-205 Industrial Triangle, Kahuta Road,
Islamabad.
107 075421 Tamsol 0.4mg Capsule 15-05-2013 14-05-2018 Dy.no. 12424
Each capsule contains:- 04-04-2018
Extended Release Reply submitted
Pellets:- on Dy.no.
Tamsulosin HCl … 33166 05-10-
0.4mg 2018
22- M/s. Pharmatec Pakistan (Pvt) Ltd., D-86/A, S.I.T.E, Karachi.
108 004204-EX Apocam 7.5mg Tablet 02-07-2013 01-07-2018 Dy.no.21548
Meloxicam … 7.5mg
109 004205-EX Apocam 15mg Tablet Do Do Do
Meloxicam … 15mg
110 004206-EX Prepase Tablet Do Do Do
Losartan Potassium …
50mg
111 004207-EX Prepase-H Tablet Do Do Do
Losartan Potassium …
50mg
Hydrochlorothiazide …
12.5mg
112 020341 Alerid Syrup 31-10-1997 17-07-2018 Do
Each 5ml contains:- Change of
Cetirizine brand name
Dihydrochloride … 5mg dated
18-07-1998
113 020342 Alerid Tablet Do Do Do
Cetirizine
Dihydrochloride … 10mg
23- M/s. Getz Pharma Plot No. 30-31, Sector-27, Korangi Industrial Area, Karachi.
114 019866 M-Low 10mg Tablet 30-06-1997 10-02-2019 Dy.no.43371
Each tablet contains:- Change of 20-12-2018
Amlodipine Besylate … brand name
10mg dated
11-02-2009
115 019865 M-Low 5mg Tablet 15-04-1997 10-02-2019 Dy.no.43371
Each tablet contains:- Change of 20-12-2018
Amlodipine Besylate … brand name
5mg dated
11-02-2009
24- M/s. Tabros Pharma (Pvt.) Ltd., Karachi
116 021790 Arix Syrup 20-05-1998 19-05-2018 Dy.no.7522
Each ml contains 27-02-2018
Cetirizine
Dihydrochloride…. 1mg
117 021791 Arix Tablets 20-05-1998 19-05-2018 Dy.no.7523
Cetrizine
Dihydrochloride…10mg
118 021792 Motim Tablets 20-05-1998 19-05-2018 Dy.no.7521
Domeperidone….10mg
119 021793 Motim Suspension 20-05-1998 19-05-2018 Dy.no.7511
Domeperidone….1mg
120 021798 Klic Tablet 50mg 20-05-1998 19-05-2018 Dy.no.7512
Each tablet contains: Change of 27-02-2018
Diclofenac brand name
Potassium…..50mg dated
121 021799 Fusil Cream 20-05-1998 19-05-2018 Dy.no.7509

Fusidic acid…..2%
122 021800 Fusil Ointment 20-05-1998 19-05-2018 Dy.no.7508
Fusidic acid…..2%
123 021805 Ronil Injection 250mg 20-05-1998 19-05-2018 Dy.no.7516
I.V. 27-02-2018
Each vial dry substance

contains:
Ceftriaxone
USP…250mg
(as Ceftriaxone Sodium)
I.V. 27-02-2018
contains:
Ceftriaxone
USP….500mg
125 021807 Ronil Injection 1g I.V. 20-05-1998 19-05-2018 Dy.no.7524
Each vial dry substance 27-02-2018
contains:
Ceftriaxone
USP…..1000mg
I.M. 27-02-2018
contains:
Ceftriaxone
USP….250mg
I.M. 27-02-2018
contains:
Ceftriaxone
USP…..500mg
128 021810 Ronil Injection 1g I.M. 20-05-1998 19-05-2018 Dy.no.7514
Each vial dry substance 27-02-2018
contains:
Ceftriaxone
USP….1000mg
129 021811 Zatron Injection 250mg 20-05-1998 19-05-2018 Dy.no.7520
IM/IV 27-02-2018
Each vial contains:
Ceftazidime
USP….250mg
130 021812 Zatron Injection 500mg 20-05-1998 19-05-2018 Dy.no.7519
IM/IV 27-02-2018
Each vial contains:
Ceftazidime
USP….500mg
131 021813 Zatron Injection 1gm 20-05-1998 19-05-2018 Dy.no.7517
IM/IV 27-02-2018
Each vial contains:
Ceftazidime
USP….1000mg
132 021814 Fenac Tablet 20-05-1998 19-05-2018 Dy.no.7510
Diclofenac
Sodium….50mg
M/s. Opal Laboratories Pvt. Ltd.,Karachi
133 000841-Ex Per-Plus Syrup 23-02-2008 22-02-2018 Dy.no.4402
Vitamin B1……25mg
Vitamin B2…..10mg
Vitamin B6……6mg
Vitamin B12……50mcg
Calcium
Pantothenate…..15mg
Inositol …….30mg
Ascorbic Acid…..450mg
Lysine Mono
HCl…..200mg
Nicotinamide……108mg
Submitted for the consideration of Board.

Case No. 2 Correction in Typographical Errors
Following typographical errors need to be corrected considered in 279th meeting
Sr. Reg. Date of Decision of the Typographical
Firm Name Brand Name
No. No. Reg. Board Error
1. M/s. Wilshire 049007 Zepose 75mg Tablet 20/08/2008 w.e.f. 20/08/2018 Initial
Laboratories, Each tablet contains: till 19/08/2023 Registration date
Lahore Irebesartan …. 75mg is corrected as
26-02-2008
accordingly
validity is
corrected as
w.e.f 26-02-2018
till 25-02-2023
26-02-2008
accordingly
validity is
corrected as
w.e.f 26-02-2018
till 25-02-2023
26-02-2008
accordingly
validity is
corrected as
w.e.f 26-02-2018
till 25-02-2023
4. M/s. Wilshire 049976 Foliant 10mg Tablet 18/07/2008 w.e.f. 18/07/2018 Composition is
Laboratories, Each tablet contains: till 17/07/2023 corrected as
Lahore Naproxyn Memantine HCl
Sodium …. 250mg 10mg
5. M/s. Wilshire 052816 Dmard 2.5mg Tablet 18/09/2008 w.e.f. 18/09/2018 Initial
Lahore Methotrexate …. 2.5mg is corrected as
18-11-2008
accordingly
validity is
corrected as
w.e.f 18-11-2018
till 17-11-2023
6. M/s. Wilshire 074294 Water for Injection 31/01/2013 w.e.f. 31/01/2018 Product detail is
Laboratories, Contains: till 30/01/2023 corrected as
Lahore Distilled Water for Water for
Injection Injection
7. M/s. Wilshire 074295 Lignocaine 1% Injection 31/01/2013 w.e.f. 31/01/2018 Product detail is
Laboratories, Contains: till 30/01/2023 corrected as
Lahore Lignocaine HCI …. Lignocaine 1%
10mg Injection
Case No.3 Applications Received with Shortcomings

This section apprised the Board that Directorate of (PE&R) is dealing with number of
applications submitted for renewal of drugs which are incomplete or have shortcoming especially with
reference to the submitted prescribed renewal fees.
The following applications for renewal of drugs are submitted on Form 5-B after the expiry of
validity of the certificate of registration but within sixty days after validity of certificate of registration.
The applications for renewal are incomplete with reference to renewal application fee or having some
other deficiency.
RULE 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate of
registration). A certificate of registration under this chapter, [shall unless earlier suspended or
cancelled, be in force for a period of five years from the date of [Registration of the drug] and may
thereafter be renewed for period not exceeding five years and a certificate to this effect shall be issued
within one month] at a time.
Provided that an application for the renewal of registration shall not be entertained unless it has been
made within sixty days after the expiry of the registration and when an application has been made
aforesaid the registration shall subject to the orders passed on the application for the renewal continue in
force for the next period of five years and a certificate to this effect shall be issued within one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal certificate
shall be issued, if in the opinion of the Registration Board it is necessary to do so in the public interest
Following cases are placed below for the consideration of Registration Board.
i) With Prescribed Fee
a) M/s. Eros Pharma (Pvt) Ltd., 94-95/23, Korangi Industrial Area, Karachi.
Sr. Initial date of
Reg. No. Product Name Application Receiving date
No. Registration
1. 067105 Enac Suspension 25-11-2010 Due date (24-11-2015)
Each 5ml contains:- Firm submitted fee of Rs.10,000/-on
Ibuprofen … 100mg 30-11-2015.As the renewal application
Pseudoephedrine HCl … is received late but within 60 days after
30mg expiry of Reg.,so fee of Rs.10,000/-
submitted by firm on 05-09-2018.
2. 011917 Erocof-A Syrup 22-11-1990 Due Date (21-11-2015)
Each 5ml contains: Firm submitted fee of Rs.10,000/-on
Ammonium 30-11-2015.As the renewal application
Chloride….100mg is received late but within 60 days after
Sodium Citrate…..60mg expiry of Reg.,so fee of Rs.10,000/-
Chlorpheniramine submitted by firm on 05-09-2018.
Maleate….2mg
Ephedrine HCl….7mg
Menthol……1mg
b) M/s. Innvotek Pharmaceuticals, Plot No. 35, Industrial Triangle, Kahuta Road, Islamabad.
Sr. Reg. Initial date of
Product Name Application Receiving date
No. No. Registration
1. 072851 Inmox Eye Drops 19-08-2011 Due date (18-08-2016)
Each ml contains:- Received within 60 days after expiry
Moxifloxacin as HCl … 5mg of Reg. with fee of Rs.20,000/-
deposited on 19-09-2016.
c) M/s. SPL
Pharmaceuticals (Pvt.) Ltd., Peshawar
1. 073351 Roxim 20mg Capsule 07-09-2012 Due date (06-09-2017)
Each capsule contains: Received within 60 days after expiry
Piroxicam Beta –cyclodextrin of Reg. with fee of Rs.20,000/-
equivalent to deposited on 03-10-2017.
Piroxicam…..20mg
2. 073352 Polyfol 100mg Capsule 07-09-2012 Due date (06-09-2017)
Each capsule contains: Received within 60 days after expiry
Iron Polymaltose Complex of Reg. with fee of Rs.20,000/-
equivalent to Elemental deposited on 03-10-2017.
Iron…..100mg
Folic Acid…..550mcg
3. 073353 Q-Flox 250mg Tablet 07-09-2012 Due date (06-09-2017)
Each tablet contains: Received within 60 days after expiry
Ciprofloxacin (as of Reg. with fee of Rs.20,000/-
HCl)……250mg deposited on 03-10-2017.
4. 073354 Voflox 250mg Tablet 07-09-2012 Due date (06-09-2017)
Each tablet contains: Received within 60 days after expiry
Levofloxacin Hemihydrate of Reg. with fee of Rs.20,000/-
Equivalent to deposited on 03-10-2017.
Levofloxacin….250mg

ii) Cases For Imported Pellets
a) M/s. Hoover Pharmaceuticals (Pvt.) Ltd., Lahore
Sr. Reg. No Products/Name Initial Date of Application receiving date and fee
No Registration submitted date and due date
1 065932 Gatolin Capsule 20mg 06-10-2010 Due Date (05-10-2015)
Each capsule contains: Fee of Rs. 10,000/- deposited on
Omeprazole 29-09-2015. As these are imported Pellets
(Pellets)….20mg from M/s.Similax Laboratories Ltd.
Rajbhavan Road Somajiguda Hyderabad
India So remaining Fee of Rs. 10,000/-
deposited on 17-10-2018.
b) M/s. Getz Pharma (Pvt.) Ltd., Karachi
1 019364 Risek 20mg Capsule 25-06-1996 Due Date (24-06-2016)
Each capsule contains: Fee of Rs. 20,000/- deposited on
Omeprazole….20.00mg 13-04-2016. As these are imported Pellets
from M/s. Shouguang Fukang
Pharmaceutical, Co. Ltd. North-East of
Dongwaihuan Road Dongcheng Industrial
Area, Shougang City Shangdong Province
China.
iii) Cases For Differential Fee
c) M/s. Galaxy Pharma (Private) Limited, Karachi
1 059079 Utrogestan Vaginal 16-10-2009 Due Date (15-10-2014) Fee of Rs. 20,000/-
200mg Soft Capsule on 22-10-2014 ,remaining fee of Rs 20,000
Each capsule contains: was paid on 04-12-2017
Micronized
Progesterone……200mg
Manufacturer abroad
M/s Besins Healthcare,
Brussels Belgium
062214 Utrogestan Vaginal 27-4-2010 Due date (23-4-2015) Fee of Rs. 20,000/-on
100mg Soft Capsule 27-4-2010 ,remaining fee of Rs 20,000 was
Each capsule contains: paid on 04-12-2017
Micronized
Progesterone……100mg
Manufacturer abroad
M/s Besins Healthcare,
Brussels Belgium
Address on DSL is different from registration letter. Submitted please.
Case No.4 Cases of Imported Pellets & Bulk Import and Local Repacking
It is submitted that previously case has been placed in 284th meeting of Registration Board, inadvertently
certain information has been missed in the previous agenda. Case has again placed with the complete
detail of post registration variation for the consideration of Board. Accordingly due date and validity of
renewal will be change.
a) M/s. Sanofi Aventis, Karachi.

1. 019564 Tritace 2.5mg Tablets 08-07-1997 Due date (27-07-2016)
Each tablet contains: Change of company Fee of Rs.10, 000/- deposited on 09-05-
Ramipril…..2.5mg name from M/s. 2016. As it is bulk import and locally
Hoechst Marion repacked product from M/s. Sanofi-
Roussel to M/s. aventis S.p.A. Italy So remaining Fee
Aventis Pharma of Rs.10, 000/- deposited on 25-06-
(Pakistan) Limited, 2018.
Karachi
Dated
24-01-2002
Change of registration
from import in finished
form to bulk import
and local repacking
dated
11-02-2005
Change of
manufacturing site
abroad from Germany
to Aventis S.p.A,
scopptio (A.Q) Italy
02-06-2005
Transfer of
Registration in the
name of M/s. Sanofi
Aventis (Pakistan)
Limited, Karachi dated
28-07-2006
Change of name of
Manufacturer from
M/s. Aventis Pharma
S.p.A Italy to M/s.
Sanofi- aventis S.p.A.
Italy
Dated
20-01-2007
2. 019565 Tritace 5mg Tablets -do- Due date (27-07-2016)
Each tablet contains: Fee of Rs.10, 000/- deposited on 09-05-
Ramipril…..5mg 2016. As it is bulk import and locally
repacked product from M/s. Sanofi-
aventis S.p.A. Italy So remaining Fee
of Rs.10, 000/- deposited on 25-06-
2018.
3. 045390 Tritace 10 mg Tablets 13-06-2007 Due date (12-06-2017)

Each tablet contains: Fee of Rs.10,000/- deposited on 17-06-
Ramipril…..10mg 2016. As it is bulk import and locally
aventis S.p.A. Italy.So remaining Fee
of Rs.10,000/- deposited on 25-06-
2018.
4. 019567 Amaryl 1 mg tablets 08-07-1997 Due date (27-07-2016)
Each tablets contains Change of source from Fee of Rs.10,000/- deposited on 04-05-
Glimepride…..1mg M/s. Hoechst Marion 2016. As it is bulk import and locally
Roussel Germany to repacked product from M/s. Sanofi-
M/s. Hoechst Marion aventis S.p.A. Italy.. So remaining Fee
Roussel Italy for bulk of Rs.10,000/- deposited on 25-06-
import and local 2018.
repacking
Dated
22-12-1997
Change of company
name from M/s.
Hoechst Marion
Roussel to M/s.
Aventis Pharma
(Pakistan) Limited,
Karachi
Dated
24-01-2002
Transfer of
Registration in the
name of M/s. Sanofi
Aventis (Pakistan)
28-07-2006
Change of name of
Manufacturer from
M/s. Aventis Pharma
S.p.A Italy to M/s.
Italy
Dated
20-01-2007
5. 019568 Amaryl 2 mg tablets -do- Due date (27-07-2016)
Each tablets contains Fee of Rs.10, 000/- deposited on 02-05-
Glimepride…..2mg 2016. As it is bulk import and locally
aventis S.p.A. Italy. So remaining Fee
of Rs.10, 000/- deposited on 25-06-
2018.
Each tablets contains Change of company Fee of Rs.10, 000/- deposited on 04-05-
Glimepride…..3mg name from M/s. 2016. As it is bulk import and locally
Roussel aventis S.p.A. Italy. So remaining Fee
(Pakistan),Karachi to of Rs.10, 000/- deposited on 25-06-
M/s. Aventis Pharma 2018.
(Pakistan) Ltd.,
Karachi
Dated
24-01-2002
Transfer of
Registration in the
name of M/s. Sanofi
Aventis (Pakistan)
28-07-2006
Change of name of
Manufacturer from
M/s. Aventis Pharma
S.p.A Italy to M/s.
Italy
Dated
20-01-2007

Each tablets contains Change of company Fee of Rs.10, 000/- deposited on 04-05-
Glimepride…..4mg name from M/s. 2016. As it is bulk import and locally
Roussel aventis S.p.A. Italy. So remaining Fee
(Pakistan),Karachi to of Rs.10, 000/- deposited on 25-06-
M/s. Aventis Pharma 2018.
(Pakistan) Ltd.,
Karachi
Dated
24-01-2002
Transfer of
Registration in the
name of M/s. Sanofi
Aventis (Pakistan)
28-07-2006
Change of name of
Manufacturer from
M/s. Aventis Pharma
S.p.A Italy to M/s.
Italy
Dated
20-01-2007
Item No. III Division of Biological Evaluation & Research
Sr. No. Details of application No. of

Cases
A Imported Human Biologicals from Reference Countries/ WHO PQ 1
B Imported Human Biologicals from non- Reference Countries 3
C Imported Veterinary Biologicals from Reference Countries 4
D Imported Veterinary Biologicals from Non-Reference Countries 2
E Miscellaneous/ Deferred cases 25
Total 35
Sr. No. Assistant Director Designated No. No. of Cases

1. Mr. M. Sarfraz Nawaz AD-II 14
2. Mr. M. ZubairMasood AD-III 21
A: Imported Human-Biological from reference countries
1. Name and address of M/s Hakimsons (Impex) (Private) Ltd., Hakimsons Building, 19
Importer West Wharf Road, Karachi
Detail of DSL Copy of DSL No. 0481 valid till 15-09-2019
Name and address of Product License Holder & Manufacturer:
Manufacturer M/s CSL Behring GmbH Emil-von-Behring-Strabe 76 35041
Marburg Germany
Brand Name +Dosage Form + Beriate® 250
Strength Powder and solvent for solution for injection or infusion
Diary No. Date of R& I & fee Dy. No. 33702/2018(R&I) Date: 11-10-2018.
Rs. 100,000/- dated 09-10-2018
Composition The package contains:
1 vacuum vial with 90-134mg of dried substance containing a
human plasma fraction enriched in blood coagulation factor VIII
and having a factor VIII activity (F VIII:C) of 250 I.U., total
protein: 0.5-2.5mg
Pharmacological Group Blood Factor VIII
Type of Form Form-5F
Finished Product Ph. Eur. Spec’s
Specification
Shelf Life 36Months at 2-80C
Document Details Valid legalized CoPP No. BaCR40
Pack size & Demanded Price Pack with 250IU contain:
1 vial with powder
1 vial with 2.5ml water for injection
1filter transfer device 20/20
1 disposable 5ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster.
1’s=RS. 12930
International Availability Germany
Products already registered in ANTI HEMOPHILIC FACTOR VIII (HUMAN) by M/S
Pakistan Opulent International, Karachi
Remarks of the evaluator
Decision
B: Imported Human Biologicals from non-reference countries.
1. Name of Importer M/s CCL Pharmaceuticals (Pvt.) Ltd.

65 Industrial Estate, KotLakhpat, Lahore, Pakistan.
DSL Detail DLS No. 0011000 0002336 valid upto 06-10-2020

Name of Manufacturer M/s AryoGen Pharmed., address No: 140, corner of Tajbakhsh
street, 24th Km Tehran- Karaj Makhsous road, Alborz, Iran
Brand Name +Dosage AryoTrust (Trastuzumab) 150mg

Form + Strength White to pale yellow powder for concentrate for solution for IV
infusion
Trastuzumab…….150mg
Finished product As per Innovator
specifications
Pharmacological Group Monoclonal antibody
Shelf life 2 years at 2-80C

International Iran
availability
Products already HERTRAZTM 150 by M/s AGP Limited
registered in Pakistan Karachi
Type of Form Form 5-A,
Dy No & Date of Dy. No. 34035(R&I) Date: 15-10-2018
application, Rs. 50,000/- Date: 15-10-2018
Fee submitted
Demanded Price / Pack As per brand leader
size 1’s vial
General documentation CoPP, Certificate No. 665/37430
Dated 21/07/2018
2. Name of Importer M/s CCL Pharmaceuticals (Pvt.) Ltd.
65 Industrial Estate, KotLakhpat, Lahore, Pakistan.
Name of Manufacturer M/s AryoGen Pharmed., address No: 140, corner of Tajbakhsh
street, 24th Km Tehran- Karaj Makhsous road, Alborz, Iran
Brand Name +Dosage AryoTrust (Trastuzumab) 440mg

Form + Strength White to pale yellow powder and solvent for concentrate for
solution for IV infusion
Trastuzumab…….440mg
+
Bacteriostatic water for injection….20ml
Finished product As per Innovator
specifications
Pharmacological Group Monoclonal antibody
Shelf life 2 years at 2-80C
International Iran
availability
Products already HERTRAZTM 440
registered in Pakistan Trastuzumab for injection (r-DNA origin) 440mg/vial
(Multiple use vial) Combo pack by M/s AGP Limited
Karachi
Dy No & Date of Dy. No. 34034(R&I) Date: 15-10-2018
application, Rs. 50,000/- Date: 15-10-2018
Fee submitted
Demanded Price / Pack As per brand leader
size (1’sPowder vial + 1’s 20ml BWFI vial) Combo pack
General documentation CoPP, Certificate No. 665/37442
Dated 21/07/2018
The firm has submitted the bio-similarity data as per following detail:
WHO Data Submitted by the firm
Biosimilarity
guidelines
Quality Comparative Structure elucidation
Comparison i. Molecular Size
Physicochemical ii. Peptide mapping for primary structure
characterization iii. Glycan profile by HPLC
iv. Amino acid sequence
v. Anti- proliferation Assay (Potency) of AryoTrust and Herceptin.
vi. Charge variant by IEx-HPLC Method.
vii. Concentration by UV/Vis spectrophotometry.
viii. Purity by SDS-PAGE.
Biological Biological activity by parallel line assay

Activity
Immunochemical i. Complement-Dependent Cytotoxicity (CDC) Assays (Biological
properties Activity) of Herceptin® and AryoTrust drug Product.
ii. Antibody-Dependent Cell Cytotoxicity (ADCC) Assay (Biological
Activity) of AryoTrust and Herceptin® Drug Product.
iii. Binding assay of AryoTrust drug product to the C1q complex using
ELISA method.
iv. Binding assay of AryoTrust and Herceptin® drug product to the HER-2
using
v. ELISA method Stud.
vi. Affinity Assay of AryoTrust and Herceptin® to Fcγ.
Impurities i. Determination of Host cell DNA by Real time PCR
ii. Determination of Host cell protein by ELISA method
iii. Determination of aggregated form by SE HPLC
Stability Studies
Non-clinical In-vitro studies
Studies i. Primary Pharmacodynamics
In-vivo Studies
ii. Relative potency incomparison to Herceptin® reference standard was
assessed; as a result, BT-474 cell line was
chosen to provide optimum HER2 receptor expression.
In-vivo studies
If the quality biosimilar comparability exercise and the nonclinical in vitro
studies are considered satisfactory and no issues are identified which would
block direct entrance into humans, an in vivo animal study may not be
considered necessary (Guidelines on evaluation of monoclonal antibodies
as similar biotherapeutic products (SBPs EXPERT COMMITTEE ON
BIOLOGICAL STANDARDIZATION Geneva, 17 to 21 October 2016)
Clinical Studies A Phase III, randomized, two-armed, patient-outcome assessor-data
analyzer blinded, parallel active controlled, non-inferiority clinical trial
study of AryoTrust (AryoGentrastuzumab) efficacy and safety in Human
Epidermal Growth Factor Receptor 2–Positive breast cancer in comparison
to Herceptin® (Genentech/Roche) control (n=108, 54 pt. in each group).
Decision:
3. Name of Importer M/s Sindh Medical Store,
Sector 13B/B-10, Block 6, PECHS, Karachi
DSL details DSL No. DHSKDK(Drug)/247 dated 07-02-2019 valid till 01-
07-2020
Name of Manufacturer M/s Serum Institute of India Pvt. Ltd.,
212/2, Hadapsar, Pune 411028 Maharashtra State, India.
Brand Name +Dosage Rabishield-100 (Injectable, Solution for Injection)
Form + Strength Rabies Human Monoclonal Antibody (rDNA) 100IU/2.5mL
Rabies Human Monoclonal Antibody…………..40IU
Finished product Innovator Specs
specifications
Pharmacological Group Rabies Immunoglobulin
(20C-80C)
International Uzbekistan, Tajikistan
Availability of this
product
Similar Product already Not Registered.
registered in Pakistan
Type of Form Form-5A
Dy No & Date of Dy. No. 31433(R&I) dated 18-09-2018
application, Rs. 50000/-
Fee submitted 18-09-2018
Demanded Price/ Pack 1’s Vial (2.5mL)/ Price not provided.
size
General documentation Valid legalized CoPP No.
COPP/CERT/PD/70919/2018/11/23240/ 120168 dated 10-04-
2018 valid till 09-11-2018.
Remarks of Evaluator  The submitted CoPP was valid at the time of submission till
09-11-2018 and is expired now. The firm has submitted copy
of valid CoPP and submitted that they will submit legalized
updated document within two weeks.
 The firm has submitted WHO position paper April, 2018
which states that:
“A single monoclonal antibody (mAb) product against rabies,
which was licensed in India in 2017, has been demonstrated to
be safe and effective in clinical trials. This mAb neutralizes a
broad panel of globally prevalent RABV isolates. The
comparative advantages of mAb products include large-scale
production with standardized quality, greater effectiveness
than RIG, elimination of the use of animals in the production
process, and reduction in the risk of adverse events.”
 WHO in its technical report series 1012 stated that:
“RIGs are in short supply throughout the world. New
technology may lead to use of mAbs in Post Exposure
Prophylaxis. WHO has recommended use of mAb “cocktails”
containing at least two antibodies against RABV, as
alternatives for RIGs in PEP. Several human mAbs have been
tested against rabies. The first (a single mAb) was recently
licensed by the Serum Institute of India. Studies so far show
the equivalence of its performance to human RIG. The
availability of this mAb could fill critical public health gaps.
As it is made by recombinant technology, it will be less prone
to problems such as availability, safety and purity. It should be
recommended for use in public health programmes, depending
on the epidemiological and geographical setting, with
monitoring of its safety and efficacy (clinical outcomes) during
post-marketing use.”
 Real time stability data provided is of 18 months for
commercial batches while 36 months data is provided for
experimental batches.
 Rabies immunoglobulin is required in category III contact with
suspected rabid animal.
 In three reference countries i.e., France, USA, and UK only
human blood derived RIG is available. The said formulation is
not marketed in reference regulatory authorities (Dog bite
Rabies is a third world disease, most of the Reference
countries are either dog bite rabies free or immunize the
susceptible animal population for rabies control).
 Rabies is a fatal disease, in severe bite cases (Type III) RIG
has to be given immediately and equine RIG is in short supply
throughout the world and NIH Islamabad is also not producing
eRIG. Hence mbRIG is a national need.
Decision:
C: Imported Veterinary Biologicals from reference countries.
1. Name of Importer M/s Vety Care (Pvt.) Ltd.

Plot No. 77, Street No.6, I-10/3 Islamabad.
DSL details DSL No. DSL-156 ICT/2013 dated 31-12-2014 valid till 30-12-2018.
Copy of Renewal receipt dated 26-12-2018
Name of M/s Intervet International B.V.
Manufacturer Wim de Korverstraat, 5831 AN Boxmeer, The Netherlands.
Brand Name NobivacTricat Trio
+Dosage Form + Lyophilisate and solvent for suspension for injection
Strength
Composition After Freeze-drying
Each dose contains:
Live FCV strain F9………at least 4.6 log10 PFU
Live FVR strain G2620A………at least 5.2 log10 PFU
Live FPLV strain MW-1………at least 4.3 log10 TCID50
Nobivac Solvent:
Each ml contains:
Disodium phosphate dihydrate..............0.31mg
Potassium dihydrogen Phosphate ….0.21mg
Water for injections to 999.16 mg
specifications
Pharmacological Veterinary Vaccine
Group
(2-80C)
International Not Provided.
availability
Products already Not Available as per record.
registered in
Pakistan
Dy No & Date of Dy. No. 11336(R&I) Dated 28-03-2018
Demanded Price / 1’s Vial Powder
Pack size 1’s Vial Solvent
General Valid legalized CoPP No. 249028 dated 21-03-2018 issued by
documentation Ministry of Agriculture Nature and Food, the Netherlands.
Remarks of  The product is not registered in country of origin. The firm

Evaluator submitted that some registrations in the Netherlands differ from the
standard registration for a product. This does not mean that the
product is in principle not registered or marketed in the
Netherlands, but only with a deviation to the standard registration.
 Real time stability data provided is of 0,9,15,21,27,36 months
instead of appropriate time intervals and only titer and residual
moisture is tested instead of all controls of finished product. The
firm submitted that according to Ph. Eur. Monograph 0062, the test
should be performed at regular intervals until 3 months beyond the
end of shelf life. For veterinary vaccines the intervals at which the
vaccines are tested for stability evaluation are not defined within
European legislation. The monograph includes following tests in
stability studies:
Virus titrations, bacterial counts or potency tests carried out at
regular intervals until 3 months beyond the end of the shelf life on
not fewer than 3 representative consecutive batches of vaccine kept
under recommended storage conditions together with results from
studies of moisture content (for freeze-dried products), physical
tests on the adjuvant, chemical tests on substances such as the
adjuvant constituents and preservatives, and pH, as appropriate.
Name of M/s Intervet International B.V. Wim de Korverstraat 35, 5831 AN
Manufacturer Boxmeer, The Netherlands
Brand Name Innovax ND-IBD
+Dosage Form +
Strength
Composition Each dose(ml) contains:
Live Herpesvirus of turkey strain HPV 360*….at least 103.3PFU**
* HPV 360 is a HVT-based recombinant encoding the NDV F protein
and the IBDV VP2 protein.
**Plaque Forming Units
specifications
Group
(Liquid Nitrogen)
availability
registered in
Pakistan
Demanded Price / 1’s Vial (2000 doses)
Pack size
documentation Ministry of Agriculture Nature and Food, the Netherlands.
Remarks of  The product is not registered in country of origin. The firm

evaluator submitted that some registrations in the Netherlands differ from the
standard registration for a product. This does not mean that the
product is in principle not registered or marketed in the
Netherlands, but only with a deviation to the standard registration.
 Real time stability data provided is of 0, 6, 12, 18, 24, 30, 36, 39
months instead of appropriate time intervals and only titer is tested
instead of all controls of finished product. The firm submitted that
according to Ph. Eur. Monograph 0062, the test should be
performed at regular intervals until 3 months beyond the end of
shelf life. For veterinary vaccines the intervals at which the
stability studies:
Name of M/s Intervet International B.V. Wim de Korverstraat, 5831 AN
Brand Name+ Nobilis MS Live
Strength
Composition Before Freeze-drying
Each dose(ml) contains:
Live attenuated Mycoplasma synoviae strain MS1…………0.67ml
After Freeze-drying
Each dose contains:
Live attenuated Mycoplasma synoviae strain MS1….≥106.5 CFU* and ≤108.0
CFU
*Colony Forming Units
specifications
Group
(20C-80C)
availability
registered in
Pakistan
Demanded Price / 1’s Vial (1000 doses)
Pack size
documentation Ministry of Economic Affairs, The Netherlands.
Remarks of  The firm then submitted another CoPP vide no. 249031 dated 21-
Evaluator 03-2018 issued by Ministry of Agriculture Nature and Food, the
Netherlands indicating that the product is not registered in country
of origin. The firm submitted that some registrations in the
Netherlands differ from the standard registration for a product. This
does not mean that the product is in principle not registered or
marketed in the Netherlands, but only with a deviation to the
standard registration.
 Real time stability data provided is of 0, 6,9, 12,15, 21,24, 27
months instead of appropriate time intervals and only titer and
residual humidity are tested instead of all controls of finished
product. The firm submitted that according to Ph. Eur. Monograph
0062, the test should be performed at regular intervals until 3
months beyond the end of shelf life. For veterinary vaccines the
intervals at which the vaccines are tested for stability evaluation are
not defined within European legislation. The monograph includes
following tests in stability studies:
Name of M/s Intervet International B.V. Wim de Korverstraat, 5831 AN
Brand Name Nobilis IB Primo QX
+Dosage Form + Lyophilisate for suspension for spray
Strength
Composition Each dose of reconstituted vaccine contains:
Live attenuated avian infectious bronchitis virus, strain D388…104.0-105.5
EID50*
*50% egg infective dose
specifications
Group
(20C-80C)
availability
registered in
Pakistan
Demanded Price / 10Cupsx 10000 doses
Pack size
General Valid legalized CoPP No. 01/17/113770 dated 13-10-2017 issued by
documentation EMA indicating product availability in exporting region.
Remarks of  Real time stability data provided is of 0, 6, 11, 18 months instead of

Evaluator appropriate time intervals and only titer and residual humidity
are tested instead of all controls of finished product. The firm
submitted that according to Ph. Eur. Monograph 0062, the test
should be performed at regular intervals until 3 months beyond the
end of shelf life. For veterinary vaccines the intervals at which the
stability studies:
D: Imported Veterinary Biologicals from non-reference countries.
1 Name and M/s Mustafa Brothers P-186-D, People Colony No. 1, Faisalabad
. address of
Importer
DSL Details License No. CEO (H) 272/-FTC/DL valid upto 12-02-2019
Name and M/s CZ Veterinaria, S.A. La Relva s/n- Torneiros 36410 Porrino (Spain)
address of
Manufacturer
Brand Name RB-51 CZV
+Dosage Form Powder and solvent for suspension for injection
+ Composition
Each dose contains:
B. abortus, strain RB51 (rough phase) … 10-34x109cfu
phosphate saline buffer
Diary No. Date 12948/2017(R&I) dated 22-08-2017.
of R& I & fee Rs. 200,000/- dated 22-08-2017.
Pharmacologic Bacterial vaccine for cattle
al Group
Finished Innovator’s specification
Product
Specification
Shelf Life 1 Year for vaccine & 1 year for solvent (2-80C)
Document Valid Legalized FSC dated 17-03-2017
Details
GMP online verification dated 07-02-2019
Certificate number NCF-1/18-GAL
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPComplianc
e.do inspection end date 2018-02-21
Pack size & 10x5 Doses of RB-51 CZV vaccine & 10x10ml Solvent
Demanded Decontrolled
Price
International Spain
Availability
Products BovishotBrucel Vaccine By M/S Tarobina Corporation, Lahore
already
registered in
Pakistan
Remarks of Provided GMP is expire firm provided the link of official website of
evaluator EUDRA from where the latest GMP status of the firm was verified.
Certificate number NCF-1/18-GAL
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPComplianc
e.do inspection end date 2018-02-21.
Accessed on dated 07-02-2019
Decision:
2 Name of M/s Vet Line International,
. Importer 55/S, 1st Floor Main Shadman Market, Lahore.
DSL details No. 60-A/DGBT/11/2015 dated 12-02-2015 valid till 11-02-2019

Name of Product License Holder:
Manufacturer M/s Laprovet Hungary Veterinary Pharmaceuticals Ltd.,
1107 Budapest Horog u. 32-34. Hungary (the wholly owned subsidiary of
Laprovet S.A.S. 7 rue du Tertreau, Arched’Oe 2,37390, Notre Dame D’
Oe, France.
Contract Manufacturer:
M/s Ceva-Phylaxia Veterinary Biologicals Co. Ltd., 1107 Budapest,
Szallass u.5. Hungary.
Brand Name Sterile Diluent of Avipox Vaccine
+Dosage Form
+ Strength
Composition Each vial of 10ml contains:
Glycerol……….1.5ml
Water, highly purified………..ad10ml
Finished As per Innovator.
product
specifications
Pharmacologic Diluent for veterinary vaccine
al Group
(20C-80C)
International Egypt, Bangladesh
availability
Products Sterile Diluent to be used with already registered vaccine AviPox (Reg.
already No. 085010)
registered in
Pakistan
Dy No & Date Dy. No.033700(R&I) dated 11-10-2018
of application, Rs. 100000/-
Demanded 20 Vials x 10ml
Price / Pack
size
General i. Valid Legalized GMP certificate of M/s Ceva-Phylaxia Veterinary
documentation Biologicals Co. Ltd., Hungary No. 02.2/3807-2/2017 dated 17-08-2017
issued by Directorate of Veterinary Medicinal Products, Hungary.
ii. Contract manufacturing certificate No. 02.2/3281-2/2018 dated 13-06-
2018 for Avipox Vaccine issued by Directorate of Veterinary Medicinal
Products, Hungary.
iii. Valid Legalized FSC No. 02.2/3917-2/2018 dated 13-07-2018 issued by
Directorate of Veterinary Medicinal Products, Hungary.
Remarks of In real time stability studies,tests are performed at the end of shelf life i.e.
Evaluator 60 months onlyinstead of regular intervals.
Case No. IV: Miscellaneous/ Deferred Cases
1. Registration of veterinary vaccines from one importer to another importer applied

by M/s Hipra Pakistan Limited, Lahore
M/s Hipra Pakistan Limited, Lahore applied for the registration of already approved
veterinary vaccines in their name from M/s Marush Private Limited, Lahore as per following
details:
Reg. Brand Name & composition as Brand Name & composition Initial Date of
No. per CoPP as per Initial Reg. letter Registrat Last
ion Date Renewal
Submissi
on
081814 EVALON EVALON 03-11- 02-11-
Suspension and solvent for oral Oral solution 2016 2021
spray
Each dose contains:
Each dose (0.007ml) of undiluted Eimeriaacervulina, strain
vaccine contains: 003.. 332-450 sporulated
Eimeriaacervulina, strain 003.. oocytes
332-450 sporulated oocytes Eimeria maxima, strain
Eimeria maxima, strain 013 196- 013……. 196-265 sporulated
265 sporulated oocytes oocytes
Eimerianecatrix, strain 033, 340- Eimerianecatrix, strain
460 sporulated oocytes 033….340-460 sporulated
Eimeriabrunetti, strain 034, 213- oocytes
288 sporulated oocytes Eimeriabrunetti, strain 034…
Eimeriatenella, strain 004, 276- .213-288 sporulated oocytes
374 sporulated oocytes Eimeriatenella, strain
004…….276-374 sporulated
Composition of the Solvent oocytes
-Brilliant blue (E 133)
-Red AC (E129)
-Vanillin
-Montanide IMS
One vial (suspension) + 1 vial

(solvent)
The firm has submitted the following documents:

1. Application on Form-5A
2. Fee Challan of Rs. 100000/- for each product.
3. Copy of Initial registration letter and last renewal submission.
4. Termination letter in name of M/s Marush Private Limited, Lahore.
5. Sole Agency Letter in name of M/s Hipra Pakistan Limited, Lahore.
Decision of 286th meeting of RB:

“Registration Board deferred the case for submission of valid legalized CoPP by the firm”
Now the firm has submitted the valid legalized CoPP issue by EMA(No. of Certificate
02/16/99203 dated 01-06-2016).
2. Imported Human Biologicals from non-reference countries.
Name and address of Importer M/s 3A Diagnostics

12-F-1, MehmoodChowk, Main Johar Town, Lahore
Details of DSL Copy of DSL No. 25-A/AiT/11/2014 Valid upto 11-08-2018
Name and address of Manufacturer M/s Ningbo Rongan Biological pharmaceutical Co., Ltd.
No.21, ChuangyeAveneu, Free Trade West Zone, Ningbo,
P.R.C.
Brand Name +Dosage Form + Strength Olvaxtar-RAB
Diary No. Date of R& I & fee 14665/2018(R&I) dated 18-04-2018.
PKR. 100,030/- dated 16-04-2018.
Composition Each dose contains:
Rabies Virus Antigen.......... .............≥2.5IU
Pharmacological Group Rabies Vaccine
Finished Product Specification The firm has demanded BP specs
Shelf Life 36 Months 2-80C
Document Details 1. Valid Legalized CoPP issued by the Market Supervision
and Administration of Ningbo on 19-09-2017.
2. Legalized invalid GMP Certificate issued byChina Food
and Drug Administration No.CN20130188 dated 18-07-
2013. Expired o 18-07-2018.
3. Original Marketing Authorization dated 03-05-2017.
4. Legalized Free Sale Certificate issued by Market
Supervision and Administration of Ningbo on 03-05-
2017.
Pack size & Demanded Price 1's vial
1’s x 5 vials
/950 PKR per vial
International Availability China
Products already registered in Pakistan Verorab of M/s Sanofi-Aventis, Pakistan
Remarks of the evaluator 1. CoPP and free sale are issued by Market Supervision and
Administration of Ningbo for which the firm has
submitted clarification that the Market Supervision and
Administration of Ningbo is the Municipal FDA works
under Chinese FDA. CFDA will not directly certify
CoPP, and the certificate will be issued by municipal
FDA of each city. The market supervision and
administration of Ningbo is Incharge of the certifying of
CoPP in Ningbo, Zhejiang province China.

Registration Board deferred the product for clarification by the firm on CoPP and free sale are issued
by Market Supervision and Administration of Ningbo instead of state FDA.
Now the firm has submitted following reply:

We, Ningbo Rongan Bio-pharmaceutical Co., Ltd hereby declare that The Market Supervision and
Administration of Ningbo is established as the municipal government department mainly responsible for
industry and commerce administration and food and drug administration, hanging the board and playing
the roles of Ningbo Administration for Industry and Commerce, Ningbo Food and Drug Administration
and Office of Food Safety Commission of Ningbo and related official document is attached below.
Official Paper of Ningbo Municipal People’s Government Office
Ningbo Municipal People’s Government Office
Notices on Issuing the Regulations for Main Duties, Internal Bodies and Staffing of Market Supervision
and Administration of Ningbo
Notices on Issuing the Regulations for main duties, Internal Bodies and Staffing of Market Supervision
and Administration of Ningbo was reviewed by Committee for establishing Municipal Government
Organization, and already approved by municipal government and allowed for issuing now. Dated 06 th
May 2014
According to Implementation Opinions of the Ningbo Municipal People’s Government on Reforming and
Improving the Food and Drug Supervision System in Ningbo ((2014)No.1 Issued by Ningbo
Government), establish The Market Supervision and Administration of Ningbo. It’s the municipal
government department mainly responsible for industry and commerce administration and food and drug
administration, hanging the board and playing the roles of Ningbo Administration for Industry and
Commerce, Ningbo Food Drug Administration and Office of Food Safety Commission of Ningbo.
1. Duty Adjustment
(1) Included duties
1. Integrate the duties of previous municipal Administration for Industry and Commerce and
municipal Food Drug Administration, incorporate them into municipal Market Supervision and
Administration.
2. Incorporate the duties of municipal office of Food Safety Commission in municipal Market
Supervision and Administration, including comprehensive coordination of food safety, organizing to
investigate serious incidents of food safety, examination and inspection of food safety.
3. Incorporate the duties of municipal Bureau of Quality and Technical Supervision in municipal
Market Supervision, including food drug safety supervision in manufacturing process, administrative
licensing and onsite inspection as well as compulsory test for cosmetics manufacturing.
2. Main duties
(1) Carry out laws, regulations, provisions and policies in industry & commerce administration and
food and drug administration; draft relevant local rules and regulations.
(2) Responsible for the registration of market entities such as various enterprises, cooperatives, units
and individuals engaged in business activities, and resident representative offices of foreign
(regional) enterprises, and administrative licensing for food, drug, medical equipment, health care
food, cosmetics, etc.
Submitted for consideration of the Board
3. Product applied by M/s Immunonet Pharma (Pvt.) Ltd Lahore deferred in 286 th
meeting of Registration Board.
Following human Biological applied by M/s Immunonet Pharma (Pvt.) Ltd Lahore
deferred in 285th meeting of Registration Board as per following details:
Name of Importer M/s Immunonet Pharma (Pvt.) Ltd.,
12-F-1, Mahmood Chowk, Johar Town, Lahore, Pakistan
DSL details License No: 05-352-0066-034495D valid upto 05-July-2020
Name of Manufacturer M/s Xi’an Huitian Blood Products Co., Ltd
Add: No.2369 the 2ndBaiiu Road, Modern Textile industrial
Park, China
Brand Name +Dosage Form + Human Immunoglobulin (pH4) for Intravenous Injection
Strength
Composition Each mL contains:
Human immunoglobulin-G (active ingredient) ….50mg
Maltose (Stabilizer) …………………………...….90-110mg
Finished product B.P Specs
specifications
Pharmacological Group Plasma derivative product
Shelf life 36 months at 2-80C

Approval status in Reference Flebogamma DIF 50 mg/ml solution for infusion
countries
International availability China

Products already registered in Human Immunoglobulin (PH4) For Intravenous Injection. of
Pakistan M/s 3a Diagnostics, Lahore
Dy No & Date of application, Dy. No. 14466(R&I) Date: 18-04-2018
Fee submitted Rs. 100,000/- Date: 12-04-2018
Demanded Price / Pack size Rs. 38000Pkr. / 50ml vial
General documentation Valid legalized GMP Certificate No. CN20160017 valid until
22/02/2021
Valid legalized FSC Certificate No. 2017-S001 Issuing date 05-
07-2017 valid for two years.
Remarks of Evaluator Accelerated Stability data of applied product is not submitted
by the firm. Firm submitted a document in which they
highlighted the Heat stability test which shows that “No
gelation at 570C for 4 hours.
Decision of 285th meeting of Registration Board:
“Registration Board deferred the case for submission of data of accelerated stability studies for
three (03) batches”
Now the firm has submitted the accelerated stability data.

“Registration Board deferred the application and advised DBER to summarize the data in next
board meeting.”
Under the heading of stability data following test performed by the firm:
Parameters:
i. Physical appearance
ii. PH
iii. IgG content
iv. Purity
v. IgG components
vi. Diphtheria antibody titer
vii. Anti-HBs
viii. ACA (%) Anti-complement activity
ix. PKA (pre-kallikrein activator)
x. Sterility
4. Imported Veterinary Biologicals from non-reference countries.
Name of Importer M/s Hivet Animal Health Business, Lahore
DSL details License to sell drug as Distributor renewed upto: 09-02-2019

Name of Manufacturer M/s Beijing sinder-vet technology co., ltd. Address: No. 118,
shunyu road, Beijing Tianzhu airport economic development
zone, shunyi district Beijing
Brand Name +Dosage Form + SINVAC ND+H9
Strength Emulsion
Composition Each dose contains:
Newcastle disease antigen inactivated (La Sota strain) (before
inactivated virus content ≥ 108.0EID50/0.1ml)
Avian influenza antigen inactivated (H9 subtype, SS strain)
(before inactivated virus content ≥ 107.4EID50/0.2ml)
Finished product specifications As per innovator specification.
Pharmacological Group Poultry vaccine
Shelf life 18 months at 2-80C

International availability China
Products already registered in ME FLUVAC H9+ND of M/s Bromed animal health, Lahore
Pakistan
Dy No & Date of application, Dy. No. 21702(R&I) Date: 21-06-2018
Fee submitted Rs. 100,000/- Date: 21-06-2018
Demanded Price / Pack size Decontrolled/ 500ml/Bottle
General documentation Valid legalized GMP valid 04/01/2016-3/1/2021
Original Valid legalized FSC dated 12-09-2018
Remarks of Evaluator Firm submit accelerated Stability data of applied product at

room temperature for 2 days and for 6 months at 100C.

“Registration Board deferred the application for clarification on submission of 2 days accelerated stability
studies”
Firm requested for exemption of accelerated stability data as per decision of 286th meeting of
Registration Board.
Remarks of evaluator:
Registration Board in its 286th meeting adopted theEuropean framework for stability testing of
vaccines for veterinary use developed in the light of European Pharmacopoeia 9.5 (General
Monograph (0062) and European Directive 2001/82/EC (II-Title) for all veterinary vaccines
which states that the stability should be evaluated under the recommended storage conditions. As
the storage conditions of vaccines is 2-80C (unless otherwise stated), the European
Pharmacopoeia requires to perform the stability studies only at 2-80C. Moreover, the European
Directive 2001/82/EC (II-Title) does not require performing accelerated stability studies for
vaccines.
Submitted for consideration of the Board
5. Request for issuance of registration letter on new company name/title.
Following products of M/s. Merck, specialties (private) limited Karachi havebeen

approved in 240th meeting of Registration Board. Registration letters were not issued due to
change in importer name which is now approved in 279th meeting of Registration Board from
M/s Merck Specialties (Private) Limited to M/s Martin Dow Marker Specialties (Private)
Limited.
Now firm requested to issue the registration letter with new approved importer name. The details
of approved products are as under:
Sr. Importer/ Brand Name & Composition Decision of RB

# Manufacturer
1. M/s Martin Gonal-f Pen 300 IU (22 ug)/0.5ml M-240
Dow Marker Solution for Injection in a pre-filled pen Approved
Specialties Each 0.5ml contains: -
(Private) One cartridge delivers 300IU Follitropin Alpha,
Limited. equivalent to 22 Micrograms.
Karachi (Gonadotropins)
2. Gonal-f Pen 450 IU (33 ug)/0.75ml
M/s. Merck Solution for Injection in a pre-filled pen
Serono Each 0.75ml contains: -
One cartridge delivers 450IU Follitropin Alpha,
S.P.A. VIA
equivalent to 33 Micrograms.
Delle (Gonadotropins).
3. Magnolie Gonal-f Pen 900 IU (66 ug)/1.5ml
(LOC. Solution for Injection in a pre-filled pen
FrazioneZona Each 1.5ml contains: -
Industriale), One cartridge delivers 900IU Follitropin Alpha,
Italy. equivalent to 66 Micrograms.
(Gonadotropins)
4. Ovidrel 250ug/0.5ml
Solution for Injection Pre-filled Syringe
Each pre-filled syringe contains; -
Choriogonadotropin alpha……250ug
(Gonadotropins)
Decision of 279th meeting of RB regarding change in importer name:

Registration Board approved the change in name of importer of Gonal-F 75IU Injection
(Reg. No. 028418) & Erbitux 5mg/ml Injection (Reg. No. 052292) from M/s Merck
Specialities (Private) Limited to M/s Martin Dow Marker Specialities (Private) Limited.

a. Application with Fee Challans of Rs. 100,000/- for each product.
b. Copy of Drug Sale License with new name valid till 27th Nov. 2019.
c. Copy of Approval of new name by SECP / registrar of firm.
d. NOC with new name of importer by Manufacturer instead of Sole Agency agreement.
e. Undertaking by the firm that no case is pending at any forum / court of law regarding
previous name.
f. Undertaking that the provided information/ documents are true/ correct.

6. Inclusion of Japanese Pharmacopoeia specification of Jilifen 300ug injection.
M/s AA Pharma, Karachi applied for the inclusion of Japanese pharmacopoeia
specifications in registration letters of following products;
Reg. Name of Name & Date of Date of transfer Date of
No. Manufacturer Composition of the initial of Registration Submission of
Product Registration renewal
045618 M/s Hangzhou Jilifen 300ug/1.2ml 16-04-2007 08-06-2011 14thJan, 2012
Jiuyuan Gene Injection &
Engineering Each 1.2mL contains: 08-06-2016
Co., Ltd., RHG-CSF…300ug.
Hangzhou,
China
The firm has submitted following documents;

i. Fee of Rs. 5000/-.
ii. Copy of initial Registration letter
iii. Copy of transfer of Registration
iv. Original Renewal applications.
v. Undertaking from Principal.
vi. Official Monograph of Japanese Pharmacopeia.
7. Imported veterinary Biologicals approved in 286th meeting of Registration Board
M/s. Hipra Pakistan (Private) Limited, Lahore request for registration of following
registered imported veterinary drugs from the name of previous importer M/s. Marush (Pvt)
Limited, K-123, Model Town, Lahore to their name were approved in 286th meeting of
Registration Board. The details are submitted as under:-
Sr. Registration letter processed with Brand Approved Brand Name & composition
No. Name & composition
1. HIPRAVIAR-B1/H120 HIPRAVIAR-B1/H120
Freeze-dried tablet and solvent for suspension Freeze-dried tablet and solvent for suspension
Composition per dose (0.03ml)
Live Newcastle disease virus attenuated B1 Composition per dose (0.03ml)
strain…………….106.5 – 107.8 EID50 Live Newcastle disease virus attenuated B1
Live Infectious Bronchitis virus, attenuatedstrain
H120 strain…………….103 – 105 DIE50 ….106.5 – 107.8 EID50
*50% infective dose in chicken embryo Live Infectious Bronchitis virus, attenuated
H120 strain
Solvent for suspension ..103 – 105 DIE50
Disodium phosphate *50% infective dose in chicken embryo
dodecahydrate…..0.087mg
Potassium dihydrogen
phosphate……..00006mg
Sodium
chloride………………………..0.24mg
Potassium
chloride…………………….0.006mg
Patent blue (E-
131)….…………………0.003mg
Water for injection……………………0.03ml
q.s.ad.
2. HIPRABOVIS-4 HIPRABOVIS-4
Lyophilisate and solvent for Injectable Lyophilisate and solvent for Injectable
suspension suspension
Composition per dose (3ml):
Composition per dose (3ml):
Composition of Liquid fraction: Inactivated Infectious Bovine Rinotracheitis
Inactivated Infectious Bovine Rinotracheitis Virus, strain LA……ELISA≥50
Virus, strain LA…………….…ELISA≥50 Inactivated Parainfluenza-3 virus, strain
Inactivated Parainfluenza-3 virus, strain SF4…………………………….IHA≥1/16
SF4…….……….IHA≥1/16 Inactivated Bovine Viral Diarrhoea Virus,
Inactivated Bovine Viral Diarrhoea Virus, strain NADL………………ELISA≥50
strain NADL…………ELISA≥50 Live Bovine Respiratory Syncytial Virus,
strain Lym-56……………..≥104TCID
Composition of freeze-dried fraction: *ELISA: Antibody titre determined by ELISA
Live Bovine Respiratory Syncytial Virus, in vaccinated rabbits.
strain Lym-56……………...≥104TCID **IHA: Antibody titre determined by
hemagglutination inhibition in vaccinated
*ELISA: Antibody titre determined by rabbits.
ELISA in vaccinated rabbits. ***CCID50: Cellular culture infective dose
**IHA: Antibody titre determined by
50%
hemagglutination inhibition in vaccinated
rabbits.
***CCID50: Cellular culture infective dose
50%
[
Registration letter are prepared as per composition in CoPP and Form-5A (detailed of solvent
incorporated from form-5A).
Submitted for information of the Registration Board.
8. Imported Human biological applied by M/s Novo Nordisk Pharma (Private)

Limited, Karachi approved in 253rd meeting of Registration Board.
Following product of M/s Novo Nordisk Pharma (Private) Limited, Karachi was
approved in 253rd meeting of Registration Board as per following details:
Name of Brand Name & composition Document Decision of RB
manufacturer Details in 253rd meeting
M/s Novo RyzodegPenfill 100 unit ml Valid legalized Approved.
Nordisk A/S, Sol for Inj CoPP No.
Novo Alle, DK- 05 Cartridge 02/15/89704 dated
2880 Bagsvaerd, Penfill contains 600 Units nmol 15-07-2015
Denmark of (420 Degludec+ 180 Aspart issued by EMA.
Insulin)
The price of aforementioned product has been fixed vide SRO 1608 (I)/2018 dated 31-12-2018
as per following details:
Sr. Brand Name & Composition Pack Size Approved M.R.P
No.
1. RyzodegPenfill 100 Unit MI Sol For Inj 5x3ml Rs. 11,392
05 Cartridge Penfill Contains: (originator Brand)
600 Units NMOL OF (420 Degludec + 180 Aspart
Insulin)
In this context it is submitted that the firm has submitted two CoPPs of above products one is
issued by EMAwhile the other one is issued by Danish Health and Medicines Authority. The
composition mentioned in the minutes of 253rd meeting is different from both CoPPs. The
composition mentioned in minutes, CoPP issued by EMA and CoPP issued by Danish Authority
is tabulated as under:
Brand Name & Brand Name & Composition Brand Name &
Composition mention in mentioned in EMA CoPP Composition mentioned in
minutes Danish CoPP
RyzodegPenfill 100 unit ml Ryzodeg Ryzodeg 100IU/ml, 3ml
Sol for Inj Solution for injection Penfill
05 Cartridge Each ml solution contains: Composition of insulin
Penfill contains 600 Units Insulin degludec/ Insulin Aspart degludec/ insulin aspart
nmol of (420 Degludec+ in the ratio of 70/30…100 units 100U/ml
180 AspartInsulin) (equivalent to 2.56 mg insulin Insulin degludec….420nmol
degludec and 1.05 mg insulin Inslinaspart………180nmol
aspart)
Moreover, the price is also fixed with composition mentioned in minutes indicating that 05
Cartridge penfill contains 600 units nmol of (420 Degludec + 180 Aspart Insulin) which is
different from both CoPPs. The compositions in EMA and Danish CoPPs are similar but in
different units. The composition mentioned on Form-5A submitted with initial application is as
per EMA CoPP.
Submitted for consideration of Board please.
9. Imported Human biological applied by M/s Novo Nordisk Pharma (Private)

Limited, Karachi approved in 262nd meeting of Registration Board.
Following product of M/s Novo Nordisk Pharma (Private) Limited, Karachi was
approved in 262nd meeting of Registration Board as per following details:
Name of Brand Name & Document Details/ Decision of RB in 262nd
Manufacturer Composition Pack Size meeting
Novo Nordisk Xultophy Copy of Legalized Keeping in view the
A/S One prefilled pen contains: CoPP No. EMA approval,
Novo Alle Insulin degludec….. 06/16/98682 Dated Registration Board
DK-2880 300Units 18-05-2016 approved the product as
Bagsvaerd Liraglutide…….. 10.8mg 3x 3ml per Import Policy for
Denmark Shelf life: 2years 5x 3ml Finished Drugs and as
per valid legalized CoPP.
The price of aforementioned product has been fixed vide SRO 1608 (I)/2018 dated 31-12-2018
as per following details:
Brand Name & Composition Pack Size Approved M.R.P
Xultophy 3ml x 1’s Rs. 7090
One prefilled pen contains: 3ml x 3’s Rs. 20,419
Insulin degludec………300 units 3ml x 5’s Rs. 34,032
Liraglutide…………….10.8mg (originator Brand)
Now the firm has submitted an application for the correction in pack size as mentioned in
initially submitted Form-5A. The firm submitted that the above product was approved by the
honorable Registration Board in its 262nd meeting as 3ml x 5’s and 3ml x 3s and due to mistake
1’ pack was missing. They have submitted updated Form-5A along with this application for the
correction of 3ml x 1’s in the initial application. The firm has submitted the following
documents:
a. Revised Form-5A
b. Fee Challan of Rs. 5000/-
c. Copy of above mentioned CoPP
In this context, it is submitted that initially the firm has submitted pack sizes of 3ml x 5’s and
3ml x 3’s which were accordingly approved by Registration Board in its 262nd meeting. The
Federal Government vide SRO 1608(I)/2018 dated 31-12-2018 notified the price of 3ml x 1’s
pack in along with already approved pack sizes. Now, the firm have requested for the inclusion
of 1’s pack in the initial application as at the time of initial submission they could not mention
the details of 1’s pack of Xultophy in Form-5A. The firm further requested to consider their case
as an inclusion in the initial application not as an additional pack and to correct the pack sizes as
mentioned in 262nd meeting and include 3ml x 1’s pack in minutes.
10. Imported Human biological applied by M/s RG Pharmaceutica(Pvt.) Ltd., Karachi

deferred in 285th meeting of Registration Board.
Following product of M/s RG Pharmaceutica (Pvt.) Ltd., Karachi was deferred in 285th
meeting of Registration Board as per following details:
Name and address of M/s RG Pharmaceuticals Pvt. Ltd.,
Importer Progressive Square No. 703, Block-6 PECHS, Shahra e Faisal,
Karachi
Detail of DSL DSL No. 0277 dated 27-01-2017 valid till 17-01-2019
Name and address of M/s LaboratorioFarmaceutico S.I.T.
Manufacturer Via Cavour 70 27035 Mede (PV), Italy
Brand Name +Dosage Form + Buccalin
Strength Film-coated tablet
Diary No. Date of R& I & fee Dy. No. 9184 (R&I) dated 19-07-2017
Rs. 100000/- dated 19-07-2017
Streptococcus pneumoniae (Inactivated)…….1000 million cells
Streptococcus agalactiae (Inactivated)…….1000 million cells
Staphylococcus aureus (Inactivated)…….1000 million cells
Haemophilusinfluenzae (Inactivated)…….1500 million cells
Pharmacological Group Human Vaccine
Finished Product Innovator’s Specs
Specification
Shelf Life 60 months (<250C)
Document Details Valid Legalized CoPP No. 10514434 dated 14-12-2017 issued
by Federal Office for Safety in Health Care Austria indicating
availability of product in exporting country.
Pack size & Demanded Price 1’s Blister (7 Film-coated Tablets)/ Rs. 1000/-
International Availability Australia, New Zealand, Switzerland etc.
Products already registered in Innovator Brand
Pakistan
Decision of RB in 285th meeting:
Registration Board deferred the case for submission of following by the firm:
a. Submission of valid legalized GMP certificate of M/s LaboratorioFarmaceuticoS.I.T.Via Cavour
70 27035 Mede (PV), Italy
b. Clarification is required regarding batches used for stability studies either pilot or commercial.
Now the firm has submitted the following:

a. Valid legalized GMP certificate No. IT/85-3/H/2017 dated 15-05-2017 M/s
LaboratorioFarmaceuticoS.I.T.Via Cavour 70 27035 Mede (PV), Italyvalid till 24-06-2019.
b. Stability study data as per following details:
Stability Storage Condition:
Real Time: 250C±20C; 60%±5%
Accelerated: 400C±20C; 75%±5%
Time Period:
Real time: 60 months
Frequency:
Real Time: 0,3,6,9,12,18,24,36,48,60
Accelerated: 0,3,6
Batch No.:
Real Time: 2076A, 2148A, 2075A
Accelerated: 7496B, 7497A, 7498A
Manufacturing Date:
Real Time: 02/2012, 03/2012, 02/2012
Accelerated: 09/2017, 09/2017, 09/2017
11. Application for Change of Address of M/s Roche Pakistan Limited, Karachi for
already registered products;
M/s Roche Pakistan Limited, Karachi has applied for change in address of their head
office for already registered following human biologicals as per following details:
Sr. Reg. Product Name Date of Initial Previous Address New Address
No. No. Registration of Importer of Importer
1. 083134 Actemra 80mg 28-04-2017 37-C, Block 6, 1st Floor, 37-B,
2. 083135 Actemra 200mg 28-04-2017 P.E.C.H.S., Block 6
3. 083136 Actemra 400mg 28-04-2017 Karachi PECHS,
Karachi
4. 090643 Actemra 29-06-2018
162mg/0.9ml
5. 087084 Gazyva 20-12-2017
6. 088527 Herceptin 16-03-2018
7. 087085 Kadcyla 100mg 22-12-2017
8. 087086 Kadcyla 160mg 22-12-2017
9. 094764 Mabthera Solution for 29-01-2019
subcutaneous
Injection 1400mg
10. 094763 Ocrevus Injection 23-01-2019
300mg/10ml
11. 087083 Perjeta 20-12-2017
12. 090644 Tecentriq 1200mg/ml 12-07-2018
The firm has submitted following documents;
i. Fee of Rs. 5000/- for each product.
ii. Copy of registration letter of above-mentioned products.
iii. Valid DSL for new address.
In this context, it is submitted that the firm has applied for new address as “1st Floor, 37-B,
Block 6 PECHS, Karachi” while in the address mentioned on new Drug sale license is “1st 37-
B, Block 6 PECHS, Karachi” and word “Floor” is missing. Moreover, the address of godowns
where the above products will be stored as per new DSL are as under:
“1. R-PI, Plot No. 116, Sector 15, K.I.A, Karachi.
2. R-PI, Plot No. 56, Sector 15, K.I.A, Karachi.”
Item No. IV Division of Quality Assurance & Laboratory Testing
Sr.#. Subject Status
01 MANUFACTURE & SALE OF SUBSTANDARD Personal Hearing

VORENAC 50 TABLETS, BATCH NO. AVT-01 BY M/S
MISSION PHARMACEUTICALS, KARACHI.
02 MANUFACTURE & SALE OF SUBSTANDARD ZENTRO Personal Hearing

40MG TABLETS BATCH NO. 18008
MANUFACTURED BY M/S BOSCH
PHARMACEUTICALS (PVT.) LTD, KARACHI.
03 CASE REFERRED BY PQCB LAHORE REGARDING Personal Hearing
SUBSTANDARD ALENSTRAN 10 MG TABLET BATCH
NO. F-T-940 MANUFACTURED BY M/S
FARMACEUTICS INTERNATIONAL KARACHI.
04 CASE REFERRED BY PQCB PUNJAB REGARDING Personal Hearing
SUB-STANDARD MERONIDE TABLET 400MG
MANUFACTURED BY M/S IRZA PHARMA (PVT) LTD
SHEIKHUPURA ROAD, LAHORE.
05 CASE REFERRED BY PQCB LAHORE REGARDING Personal Hearing

SUBSTANDARD LOSARA-P 50 MG TABLETS BATCH
NO. 9E-100 MANUFACTURED BYM/S ANEEB
PHARMACEUTICALS, LAHORE.
06 REQUEST TO TRANSFER “NOT TO DISPOSE OF”

STOCK FROM PHARMACY NATIONAL INSTITUTE OF
CHILD HEALTH (NICH), KARACHI.
07 CASE REFERRED BY PQCB PUNJAB REGARDING

SUBSTANDARD LEVAOX LIQUID MANUFACTURED
BY M/S INTERVAC (PVT) LTD 18KMLAHORE
SHEIKHUPURA ROAD, SHEIKHUPURA.
Case No.01: Manufacture & Sale of Substandard Vorenac 50 Tablets, Batch No. AVT-
01 by M/s Mission Pharmaceuticals, Karachi.
The FID-VI, DRAP Karachi visited the premises of M/s Mission Pharmaceuticals (Pvt.) Ltd., A-
94, SITE Super Highway, Karachi, on 24-09-2018 to check the GMP compliance level of the
firm and taken the following sample U/S 18(1) (c) of the Drugs Act, 1976 for the purpose of
test/analysis on prescribed Form-3:
Name: Vorenac 50 Tablets.
Composition: Each tablet contains 50mg Diclofenac
Sodium.
Registration No: 080324
Batch No: AVT-01
Manufacturing Date: Jan-2018
Expiry Date: Jan-2020
Manufactured By: M/s Mission Pharmaceuticals (Pvt.) Ltd.,
A.94, SITE Super Highway, Karachi,
The FID-VI, Karachi has forwarded one sealed portion of sample to Central Drugs Laboratory,
Karachi vide memorandum No.ARS-130-133/2018-FID-VI (K) dated 25-09-2018 as required
under Section 19(3)(i) of the Drugs Act, 1976.
The Federal Government Analyst, CDL, Karachi declared the sample as of Sub-standard
quality on the basis of dissolution vide test/analysis report No.KQ.649/2018 dated 05th October,
2018 which is violation of Section 23 (1) (a) (v) of the Drugs Act, 1976 and rules framed there
under.
The area FID-VI, Karachi vide letter No.ARS-130-133/2018-FID-VI (K) dated 10th October,
2018 has asked the firm M/s Mission Pharmaceuticals (Pvt.) Ltd., A.94, SITE Super Highway,
Karachi to explain their position in the matter of manufacturing and selling of substandard drug
with direction to recall the above said batch from the market.
M/s Mission Pharmaceuticals (Pvt.) Ltd., A.94, SITE Super Highway, Karachi submitted their
reply vide letter No: MIS/QA/016-18 dated 16th October, 2018 wherein it is stated that they have
checked their portion and retained sample of the subject cited drug and found a few tablets out of
specifications. However rests of the parameters were very much aligned. They also recalled the
remaining marketed portion of the said drug and the portion in hand is quarantined. They added
that further investigations are possible underway to find out the root cause of the problem. All
the investigation and subsequent CAPA in this connection would also be shared.
In pursuance of Section 19 (7) of the Drugs Act, 1976 The FID-VI, DRAP, Karachi submitted
the complete case for placement in the upcoming meeting of Registration Board and provided the
names of responsible which are as under:
S.No. Name Designation CNIC
1 Salman Sheikh Production Manager 42201-4158738-7
2 Ahamd Hanif Q.C. Manager 42201-5736676-6
The Division of Drug Licensing, DRAP Islamabad was requested to verify the names provided
by the FID-VI, Karachi and they provided the following names being responsible persons and
technical persons.
M/s Mission Pharmaceuticals (Pvt.) Muhammad Aleem Mirza (Managing
Ltd., Karachi Director)
M/s Mission Pharmaceuticals (Pvt.) Ltd.,
Karachi
Salman Shaikh (Production Incharge) Ahmad Hanif (Q.C Manager)
M/s Mission Pharmaceuticals (Pvt.) M/s Mission Pharmaceuticals (Pvt.) Ltd.,
Ltd., Karachi Karachi
Show cause notice has been issued to the technical staff/management of the firm – responsible
persons U/S 7(11) of the Drugs Act, 1976 vide letter no. 03-82/2018-(QC) dated 16-01-2019.
The show cause notice was served to the firm and accused persons but the firm did not submit
their reply in response to show cause notice.
The case is submitted for the consideration of the Board.
Case No.02: Manufacture & Sale of Substandard Zentro 40mg Tablets Batch No. 18008
Manufactured by M/s Bosch Pharmaceuticals (Pvt.) Ltd, Karachi.
The FID-VI, DRAP Karachi visited the premises of M/s Khan Medicos, shop No.16, Block No.
11-A, Karimabad market ST-2, FB Area, Karachi on 11-04-18 and taken the following sample
U/S 18(1) (c) of the Drugs Act, 1976 for the purpose of test/analysis on prescribed Form-3:
Name: Zentro 40mg Tablet.
Composition: Each Tablet contains 40mg Pantoprazole.
Registration No: 035547
Batch No: 18008
Manufacturing Date: 07-17
Expiry Date: 06-20
Manufactured By: M/s Bosch Pharmaceuticals (Pvt.) Ltd,
Karachi.
The FID-VI, Karachi has forwarded one sealed portion of sample to Central Drugs Laboratory,
Karachi vide memorandum No.ARS-25-26/2018-FID-VI (K) dated 11-04-2018 as required
under Section 19(3)(i) of the Drugs Act, 1976.
The FID-VI, DRAP, Karachi has also forwarded one sealed portion of sample as Board’s Portion
vide letter No. ARS-25-26/2018-FID-VI (K) dated 13-04-2018 as required under Section
19(3)(ii) of the Drugs Act, 1976.
The Federal Government Analyst, CDL, Karachi declared the sample as of Sub-standard
quality on the basis of dissolution vide test/analysis report No.KQ.SC.249/2018 dated 06th
June, 2018 which is violation of Section 23 (1) (a) (v) of the Drugs Act, 1976 and rules framed
there under.
The area FID-VI, Karachi vide letter No.ARS-25-26/2018-FID-VI (K) dated 13-06-2018 & 28-
06-2018 has asked the M/s Bosch Pharmaceuticals (Pvt.) Ltd, Karachi to explain their position
in the matter of manufacturing and selling of substandard drug with direction to recall the above
said batch from the market.
M/s Bosch Pharmaceuticals (Pvt.) Ltd, Karachi submitted their reply vide letter
No.GMRA/221/090718 dated 10th July, 2018 wherein as per contents of their reply they are not
satisfied with the results of test report of CDL, Karachi but has not challenged it properly rather
submitted to close the case.
The FID-VI, Karachi submitted that the samples of all available generic Pantoprazole
capsules/tablets were taken for test & analysis on the complaints of several healthcare
professionals regarding the efficacy of almost all generics amid the shortage of market brand.
The CDL in-vitro test also confirmed the same. Therefore it is recommended that thorough
investigations may be carried out encompassing manufacturers of brand leaders and generics also
re-sampling of all available generics Pantoprazole throughout the country may be carried out for
further investigations. It is further recommended provided the names of responsible which are as
under:
S.No. Name Designation CNIC
1 Shaikh Mohiuddin Managing Director and (42201-2175782-3)

Chawla Warrantor
2 Muhammad Ishaq Production Incharge (42101-1581154-7)
3 Imtiaz Ahmad Quality Control (42401-4079608-7)

Incharge
4 SM Chawla Warrantor
The Division of Drug Licensing, DRAP Islamabad was requested to verify the names provided
by the FID-VI, Karachi and provided the following names being responsible persons and
technical persons.
M/s Bosch Pharma (Pvt.) Ltd, Shaikh Mohiuddin Chawla, (Director)
221, Sector 23, Korangi Industrial M/s Bosch Pharma (Pvt.) Ltd,
Area, 221, Sector 23, Korangi Industrial Area,
Karachi Karachi
Mr. Ahmad Nasib, (Director) Mr. Farhan Chawala (Director)
M/s Bosch Pharma (Pvt.) Ltd, M/s Bosch Pharma (Pvt.) Ltd,
221, Sector 23, Korangi Industrial 221, Sector 23, Korangi Industrial Area,
Area, Karachi
Karachi
Mr. Zakarya Nasib, (Director) Muhammad Ishaq, (Production Incharge)
M/s Bosch Pharma (Pvt.) Ltd, M/s Bosch Pharma (Pvt.) Ltd,
221, Sector 23, Korangi Industrial 221, Sector 23, Korangi Industrial Area,
Area, Karachi
Karachi
Imtiaz Ahmad, (Quality Control
Incharge)
M/s Bosch Pharma (Pvt.) Ltd,
221, Sector 23, Korangi Industrial
Area,
Karachi
Show cause notice has been issued to the technical staff/management of the firm – responsible
persons U/S 7(11) of the Drugs Act, 1976 vide letter no. 03-47/2018-(QC) dated 16-01-2019.
The show cause notice was served to the firm and accused persons but the firm did not submit
their reply in response to show cause notice.
Case No. 03: Case Referred By PQCB Lahore Regarding Substandard Alenstran 10
Mg Tablet Batch No. F-T-940 Manufactured By M/S Farmaceutics
International Karachi.
The Secretary, PQCB, Punjab vide letter no. PQCB/R 151-04/2016 dated 31-7-2018,
which are about order of PQCB for Tehsil Darya Khan District Bhakkar stating the proceeding
and decision of PQCB regarding Sub-standard Alenstran 10 mg tablet batch no. f-T-940
manufactured by M/s Farmaceutics International, F1-A3, S.I.T.E Karachi, in its 190th meeting
held on 31-7-2018.
That case states that Provincial Inspector of Drugs, Tehsil Darya Khan District Bakkhar reported
that:
i. He, on 23-12-2015, inspected the business premises of M/s Yousaf Medical Store
AddaKohawarKalan District Bakkar and took samples of two different types of drugs on Form 4
for the purpose of test and analysis.
ii. One out of the two drug samples after test/ analysis was declared as sub-standard
by Government Analyst Drug Testing Laboratory Faisalabad as detailed below:
Name of Batch Name of DTL report DTL test report results

drug no manufacturer TRA no. and
date
Tablet f-T- M/s TRA no. Analysis with specifications:

Alenstran 940 Farmaceutics 4222/DTL
10 mg International Manufacturer’s specifications
F1-A3, S.I.T.E, Dated: 15-4-
2016 Description:
Karachi
Oblonged, biconvex film coated
tablets, having line of bisection at
one side, contained in plastic blister
of 10 tablets, packed in unit carton.
The blister contains 8 tablets
instead of 10 tablets moreover do
not bear batch no. of the product on
blister.
Assay: (Cetirizine)
Percentage: 96.50%
Limit: 90-110%
Disintegration: Not More Than 30
minutes.
Determined: comply with the

specifications.
Result: the Sample is sub-standard/

misbranded on the basis of tests
performed.
That M/s Farmaceutics International, Karachi challenged the DTL report. But the request was
not processed as the sample got expired at that time.
That the case was considered by the Provincial Quality Control Board, under section 11 of the
Drugs Act, 1976 in its 175th meeting held on 29-11-2017 and 176th meeting held on 15-12-2017.
The board decided to Conduct Product Inspection by the said panel as under:
Prof. Dr. Mehmood Ahmad (Member PQCB) convener

Mr. Munawar Hayat (Chief Drugs Controller, Punjab (member PQCB) member
The conclusion is as under:
“The product tablet Alenstran 10 mg, B. no. f-T-940 was declared sub-standard/
misbranded on physical grounds “blister contains 8 tablets of 10 tablets and batch
number not mentioned on blister”. As per DTL test report assay was 96.5%. The
firm is directed, before starting actual blistering procedure, took specimen samples
of blisters and make a part of batch manufacturing record to verify batch number,
manufacturing and expiry date. The firm is advised to improve quality control
checks on the packaging of tablets (sorting) of blisters before packaging.”
The case was again considered by the Provincial Quality Control Board, under Section 11 of the
Drugs Act, 1976 in its 190th meeting held on 31-7-2018. Chief Drugs Controller Punjab (member
of inspection panel) presented the above-mentioned product specific inspection report and
apprised the board regarding major short comings observed during inspection which includes “
In-House specifications/ methods of test/ analysis of drugs were not validated, Daily calibration
of the instruments such as UV Spectrophotometer, weighing balance and glassware was not
being performed, non-availability of the instruments i.e FTIR and TOC and incorrect schedule
for ongoing stability studies etc. The report was reviewed critically and the board expressed
serious concerns over these short comings/ nonconformities which were critical in nature. The
board agreed with the recommendations/ advice tendered by the inspection panel to the firm.
The board after due deliberation on various aspects of the case and detailed scrutiny of the
inspection report and keeping in view the gravity of nonconformities, unanimously decided
to refer the Product Specific Inspection (PSI) report to the Central Licensing Board (CLB)
DRAP Islamabad through Chief Executive Officer DRAP for information and necessary
action as required under law.
Proceeding and Decision of the 286th Meeting of Registration Board.

The case was presented before the Registration Board in its 286th meeting on 16th
November, 2018 and the Board after perusing the record/ document of the instant case
deliberated the matter in depth and decided as under:
“to issue the show cause notice and personal hearing to the firm/ responsible
persons as provided by the provincial quality control board (PQCB), Lahore for
manufacturing and selling of substandard Alenstran 10mg tablets, Batch No. f-T-940,
manufactured by M/s Farmaceutics International F1-A3, S.I.T.E, Karachi.”
Show cause notice was served to the firm as per decision of the Registration Board vide file
No.03-86/2018-QC (286-RB) on 16th January 2019.
In response to the Show cause notice, the firm submitted their reply vide their letter No. Nil
dated 22nd January, 2019 which is reproduced as under:
“The said report is not yet shared with us, neither from CLB nor from the author.
Panel has never inspected the facility and we are worried, whether it is mistakenly quoted or
otherwise as modus operandi.
There is absolutely no issue on quality of product and test report of Govt. Analyst on which SCN
builds itself confirm compliance of drug with all quality parameter. There is absolutely no safety,
efficacy or quality issue with the product.
It is therefore requested to read our earlier letter since, it is time barred case, (DTL report
issued on dated 15-04-16) after nine month delay drug inspector send us report on 19-01-17). It
is sincerely hoped that rule of law will be respected in its spirit. We will thankful of protecting
interest of justice.”
Case No. 04: CASE REFERRED BY PQCB PUNJAB REGARDING SUB-STANDARD
MERONIDE TABLET 400MG MANUFACTURED BY M/S IRZA
PHARMA (PVT) LTD SHEIKHUPURA ROAD, LAHORE.
Abid Saeed Baig, Secretary Provincial Quality Control Board, Punjab has forwarded the cases
which are about orders of PQCB for Districts Narowal, Sargodha, and Faisalabad, dated 28-4-
2018 stating the proceedings and decision of PQCB regarding sub-standard Meronide tablet
400mg manufactured by M/s Irza Pharma (pvt) ltd, 10.2 km Sheikhupura Road, Lahore , in its
185th meeting held on 28-4-2018.
Case no.1 state the brief of the case as under;
Inspector of Drugs, Tehsil & district Narowal reported that:
i. He, on 13-04-2016, inspected the premises of MSD, EDO (H) Narowal situated at
old DHQ Hospital Narowal and took the sample of below mentioned drug on
form-4 which after test/ analysis was declared substandard by Government
Analyst Drug Testing Laboratory, Faisalabad as detailed below:
DTL Report DTL
Name of Batch Name of
TRA No Report
Drug No. Manufacturer
&Date Result
M/s Irza Substandard
TRA no.
Tablet Pharma ltd,, on the basis
4545/DTL
Meronide 400 6A13 10.2 km of Friability
Dated: 22-04-
mg Sheikhupra test
2016
road Lahore.
ii. The Storekeeper of MSD, EDO (H) Narowal situated at old DHQ hospital
Narowal provided invoice/warranty nos. 5165, 5164, 5163, 5162, 5160, 5159,
5158, 5157, 5156 dated 8-4-2016 issued by M/s Irza Pharma, Lahore as a proof
of their purchase.
iii. A copy of test report of the drug sam0ple was sent to M/s Irza Pharma, Lahore
and they were asked to explain their position and to provide requisite information
in this regard but they failed to do so.
Case no.2 state the brief of the case as under;
Inspector of Drugs, tehsil & district Sargodha reported that:
i. His predecessor, on 12-04-2016, inspected the premises of Main Medicine Store,
DHQ Teaching Hospital, Sargodha and took the twenty four samples of below
mentioned drugs on form-4 for test/ analysis.
ii. One out of twenty four samples after test/ analysis was declared substandard by
Government Analyst Drug Testing laboratory Faisalabad as detailed below:
DTL Report DTL

TRA No & Report
Date Result
TRA no.
5014/DTL
Meronide 400 6A10 10.2 km of friability
Dated: 30-04-
mg Sheikhupra test
2016
Road Lahore.
iii. He, on 20-7-2017, also seized the stock of subject substandard drug on form 5.
iv. The Storekeeper of Main Medicine Store, DHQ teaching hospital Sargodha
provided invoice/warranty nos. 4755, dated 16-03-2016 issued by M/s Irza
pharma, Lahore as a proof of their purchase.
v. Warrantor portion and a copy of test report of the drug sample was sent to M/s
Irza pharma, Lahore and they were asked to explain their position and to provide
requisite information in this regard.
Case no. 3 states the brief of the case as under;
Inspector of Drugs, Tehsil Samundri, district Faisalabad, reported that:
i. His predecessor, on 28-03-2016, inspected the business premises of THQ Hospital
Tehsil Samundri district Faisalabad and took samples of one type of drug on form
4 for the purpose of test and analysis.
ii. The sample after test/ analysis was declared substandard by Government Analyst
drug Testing Laboratory Faisalabad as detailed below:
DTL Report DTL

TRA No & Report
Date Result
TRA no.
4578/DTL
Meronide 400 6B4 10.2 km of friability
Dated: 23-04-
mg Sheikhupra test
2016
road Lahore.
iii. Stock Keeper THQ Hospital Tehsil Samundri district Faisalabad provided
invoice/warranty nos. 4596, dated 11-3-2016 issued by M/s Irza Pharma, Lahore
as a proof of their purchase.
iv. A copy of test report & warrantor portion was sent to M/s Irza Pharma ltd
Sheikhupra road, Lahore and they were asked to explain their position but they
failed to do so.
case no.4 state the brief of the case as under;
Inspector of Drugs, DHQ Teaching Hospital, Sargodha reported that:
i. His predecessor, on 20-05-2016, inspected the Main Medicine Store, DHQ
Teaching hospital Sargodha and took the samples of one drug on form-4 for test/
analysis.
ii. The sample after test/ analysis was declared substandard by Government Analyst
drug testing laboratory Faisalabad as detailed below:
DTL Report DTL

TRA No & Report
Date Result
m/sirzapharma TRA no. Substandard
Tablet
ltd,, 10.2c km 6846/DTL on the basis
meronide 400 6A9
sheikhupra Dated: 09-06- of friability
mg
road Lahore. 2016 test
iii. He, on 20-7-2017, also seized the stock of subject substandard drug on form 5.
iv. The Storekeeper, Main Medicine Store, DHQ Teaching Hospital Sargodha
provided invoice/warranty nos. 4755 dated 16-3-2016 issued by M/s Irza Pharma,
Lahore as a proof of their purchase.
v. Warrantor portion and copy of test report was sent to M/s Irza Pharma, Lahore
and they were asked to explain their position and to provide requisite information
in this regard but they failed to do so.
Inspector of Drugs, Layyalpur Town, district Faisalabad reported that:
v. He, on 29-03-2016, inspected the Main Medicine Store office of Executive
District Officer (Health) Faisalabad and took thirty samples of drugs on Form-4
for test/ analysis.
vi. One out of these sample after test/ analysis was declared substandard by
Government Analyst drug Testing Laboratory Faisalabad as detailed below:
DTL Report DTL
TRA No & Report
Date Result
M/s Substandard
TRA no.
Tablet IrzaPharma on the basis
4427/DTL
Meronide 400 6B4 ltd,, 10.2 km of friability
Dated: 20-04-
mg Sheikhupra test
2016
road Lahore.
vii. Incharge of Main Medicine Office of Chief Executive Officer (Health) Faisalabad
provided invoice/warranty nos. 4583, 4584, 4589, 4590 and 4591 dated 11-3-
2016 issued by M/s IrzaPharma, Lahore as a proof of their purchase.
viii. A copy of test report & warrantor portion was sent to M/s Irza Pharma ltd
Sheikhupura road, Lahore and they were asked to explain their position and to
provide requisite information in this regard.
Inspector of Drugs, tehsil Bhalwal district Sargodha reported that:
i. Drug inspector, on 02-04-2016, inspected the premises of Medicine Store T.H.Q
hospital Bhalwal district Sargodha and took samples of three different types of
drugs on form-4 for test/ analysis.
ii. One out of these sample after test/ analysis was declared substandard by
Government Analyst Drug Testing Laboratory Faisalabad as detailed below:
DTL Report DTL

TRA No & Report
Date Result
M/s Substandard
TRA no.
4246/DTL
Meronide 400 6A9 ltd,, 10.2 km of friability
Dated: 16-04-
mg Sheikhupra test
2016
road Lahore.
iii. Medical Superintendent of T.H.Q hospital, Bhalwal provided invoice/warranty

nos. 4735 dated 16-3-2016 issued by M/s Irza Pharma, Lahore as a proof of their
purchase.
iv. Warrantor portion was sent to the M/s irza Pharma, Lahore. A copy of test report
was sent to M/s Irza Pharma was directions to explain their position and provide
requisite information in this regard.
Inspector of Drugs, Lyallpur town, district Faisalabad reported that:
i. He, on 28-4-2016, inspected the main medicine store office of Executive District
Officer (Health), Faisalabad and took samples of four types of drugs on form-4
for test/ analysis.
ii. Two out of four samples after test/ analysis was declared substandard by
Government Analyst Drug Testing Laboratory Faisalabad as detailed below:
DTL Report DTL

TRA No & Report
Date Result
M/s Substandard
TRA no.
5417/DTL
Meronide 400 5L3 ltd,, 10.2c km of friability
Dated: 10-05-
mg sheikhupra test
2016
road Lahore.
M/s Substandard
TRA no.
5418/DTL
Meronide 400 6B5 ltd,, 10.2c km of friability
Dated: 10-05-
mg Sheikhupra test.
2016
road Lahore.
iii. Incharge main medicine store provided invoice/warranty nos. 5410 dated 23-4-
2016 issued by M/s Irza pharma, Lahore as a proof of their purchase.
iv. Incharge main medicine store provided invoice/warranty nos. 5411 dated 23-4-
2016 issued by M/s Irza Pharma, Lahore as a proof of their purchase.
v. A copy of test report and warrantor portion was sent to M/s Irza Pharma with
directions to explain their position and provide requisite information in this
regard.
All the Drug Inspectors as mentioned above requested for grant for prosecution
against the firm and accused persons who have contravened the provisions of
sections 23/27 of the Drugs Act, 1976/ DRAP Act 2012 and rules framed there
under.
The said cases were presented before PQCB Lahore in its 177th meeting held on
30-12-2017. The board decided to conduct PSI of M/s Irza Pharma Lahore.
The conclusion of PSI is as under:
“The firm is manufacturing uncoated tablet Meronide without research and
development. Whereas the leading brands of this product are available in film
coating form in market. The firm has shifted the uncoated formulation into film
coating in May 2016 without any permission/ intimation to DRAP. On
evaluation of bmr it was observed that following changes in the master formula
was made by adding sugar in two batches and without adding sugar in four
batches. The result of friability result varying by adding binder and non-
addition of binder. Average weight of tablet shows that amount of excepients
added in 400 mg tablet is slow. In this regard firm is violating many conditions
of schedule B-II of the Drugs Act 1976. So. The firm is directed to redesign and
reevaluate its formulation and perform stability study of following products
under intimation and approval of DRAP.
Tablet Meronide 400mg R.no 025636
Tablet meronide200mg R. N 025635”
The PSI report was presented before PQCB in its 185th meeting held on 28-4-
2018. The board unanimously decided to grant permission for prosecution against
the following accused persons in the drug court.
i. M/s Irza Pharma ltd, 10.2 km Sheikhpura road, Lahore through its chief
executive Muhammad Imran Jawa.
ii. Muhammad Imran Jawa Chief Executive

iii. Abid Ali Jawa Warrantor
iv. IftikharMasud Plant Manager
v. Savaira Sultan Director
vi. Azamali production Incharge
iv. AsimMehmood Quality Control Incharge
Of M/s Irza pharma Lahore for the offences of
i. Manufacturing for sale/ stocking for sale/ sale of substandard drug.
ii. Issuance of its false warranty.
The board further decided to recommend Drug Regulatory Authority of
Pakistan (DRAP) Islamabad for cancellation of the registration of the subject
drug product i.e Meronide tablet.
13. Decision of 284th meeting of Registration Board
The board decided to issue the show cause notice and personal hearing to firm
responsible persons as provided by PQCB lahore for manufacturing and selling of different
batches of substandard i.e meronide tablets.
14. The show cause notice was served to the firm on 23rd October, 2018.

Mr. Muhammad Imran Jawa (Managing Director) and Azam Ali (production Manager) of M/s
Irza Pharma ltd, 10.2 km Sheikhupra road Lahore appeared on behalf of M/s Irza Pharma,
Lahore plead instant case of Substandard drug Meronide 400 mg Tablet, Batch No. 6A13, 6A10,
6B4, 6A9, 5L3 and 6B5 before the Board in its 286th meeting on 16th November, 2018.The
Board after hearing the accused deliberated the matter in depth in the light of available record/
investigation report of FID decided as under:
1. Show cause notice should be served to the firm for violation of the condition of the
registration as the firm was having registration of the uncoated tablets. Why they
shifted for manufacturing of coated tablets without prior approval from
Registration Board, DRAP, Islamabad.
2. They should submit product development data for change in the coating of the
tablets.
3. The registration of the said product shall remain suspended till the verification of
data following panel:
a. Director DTL, Lahore.
b. Area FID, DRAP, Lahore.
No.03-86/2018-QC (286-RB) on 16th January 2019.
In response to the show cause notice, the firm submitted their reply vide reference No.
IP/04/2019 dated 25-01-2019 and is reproduced as under:
“Both Meronide 200mg tablets and Meronide 400mg tablets were registered in 12-05-2000 with
the DRAP having registration # 025635 and 025636 respectively.
There was nothing mentioned FILM COATED etc in the drug registration letter.
The honorable PQCB board suggested at the time of hearing to apply for Film-coat to the
DRAP Islamabad for both products to avoid discrepancy (Friability). Therefore we applied on
25-10-15. Reg. #IP/05/2018 to DRAP. Then received the letter “Correction in
formulation/specification with film coat permission”
As M/s Irza Pharma is serving the nation since 1971 and has the recognition among the people
of our beloved country as manufacturing unit of quality products.
The minor deviation in the formulation of the Meronide tablets (Both 400mg & 200mg) as
mentioned in the letter received from your good office. In this regard it is humbly stated that the
possibilities of deviation might be there due to environmental circumstances (Machine
operator/Equipment being used/analyst etcetcand the formulator/production manager may take
the onset decision (which must be documented) to verify their particular problems like capping,
lamination, desired hardness, chipping etc.
The pharmaceutical products are based upon by quality of design. This has firm relationship
between the product and the patient. If product is chemically fine having no risk of any potential
hazard the post formulation variation has no value to object. Si it’s not fall in violation as
mentioned. Although we have the R&D section and w make Pre-Requisite prior to formulate any
product. (as desired by the DRAP) and then we started film coating.
The said product had been tested/analysed by almost four major DTL’s of Punjab like;
 DTL Lahore
 DTL Multan
 DTL Bahawalpur
 DTL Rawalpindi
These are the state of art and reliable DTLs but only Fiasalabad DTL failed our product on the
basis of Friability which has no impact upon the health nor health injurious.
We have supplied millions of Meronide tablets all over the country but none of the DTL (with a
few exceptions) questioned upon the quality (potency/strength. All parameters were in
compliance.
Anyhow we M/s Irza Pharma provides the dossier of product development data of both products
for your kind perusal and technical evaluation.
Therefore it is prayed to your honor to please have a sympathetic consideration and wave off the
case in the best interest of the patients due to our cost effective quality medicine. We assure your
good office that we shall not leave any stone unturned for the compliance of GMP.
We do hope for justice and sympathetic consideration to resume the registration of both products
in the best interest of the nation.
We M/s Irza Pharma requested your good office if the supported documents does not in
compliance with the demanded information then please rehear in person before honorable board
to fulfill the dispensation of the justices equality. We shall very oblige for this favour.”
Case no. 05: CASE REFERRED BY PQCB LAHORE REGARDING SUBSTANDARD
LOSARA-P 50 MG TABLETS BATCH NO. 9E-100 MANUFACTURED
BYM/S ANEEB PHARMACEUTICALS, LAHORE.
The Secretary, PQCB, Punjab vide letter no. PQCB R-521-09/2009 dated 31-7-2018, which are
about order of PQCB for Tehsil Rahim Yar Khan stating the proceeding and decision of PQCB
regarding Sub-standard Losara-P tablets batch no. 9E-100 manufactured by M/s Aneeb
Pharmaceuticals, Lahore, in its 190th meeting held on 31-7-2018.
That case states that Provincial Inspector of Drugs, Tehsil Rahim Yar khan reported that:
i. He took the drugs sample tablet Losara-P 50mg batch no. 9E-100 for the purpose
of test/ analysis from the premises of medicine store Sheikh Zaid Medical College Rahim Yar
Khan.
ii. The drug sample was declared as sub-standard by Government Analyst Drug
Testing Laboratory Lahore as detailed below:
Name of Batch Name of DTL report DTL test report results

drug no manufacturer TRA no. and
date
Tablet No. M/s Aneeb TRA no. Analysis with specifications:

Losara-P 9E- Pharmaceutical 7925/DTL
50mg 100 , Lahore Manufacturer’s specifications
Dated: 02-09-
2009 Description:
Pink color round coated tablets.

Having rough outer surface with
white patches and have granular
appearance packed in blister. A
part of some tablets remained stick
with aluminum foil on pressing out
tablet from blister
Assay: (Losartan Potassium)
Percentage: 97.4%
Result: the sample is sub-standard

on the basis of tests performed.
PREVIOUS PROCEEDINGS AND DECISION BY THE BOARD:
The case was considered in 60th meeting of PQCB dated: 30-1-2010. The board decided to issue
warning to the firm with direction to replace the entire substandard stock with fresh stock and the
destruction of substandard stock according to contractual obligations. The board further decided
to constitute a committee comprising of the followings for inspection of the firm to ascertain
GMP compliance and submit the report.
 Professor Dr. Naveed Iqbal Ansari (Member PQCB).

 Professor Dr. MahboobRabbani (Member PQCB).
 Muazzam Ali khan (Chief Drugs Inspector).
That the case was again considered by the Provincial Quality Control Board in its 161st meeting
held on 15-4-17. The board reconstituted the inspection committee comprising of Chief Drug
Controller, Punjab to conduct Specific Inspection along with drug inspectors industries and
submit report to PQCB. The conclusion is as under:
 The panel is of opinion that batch size 9E100 was 2000000 tablets while
capacity of film coating pan was less than batch size (200000/ pan & two pans
were available) so coating was performed in different portions. Coating was
also not uniform that lead to physical deformity.
 The firm is directed to produce batch size of each product according to capacity
of production equipment.
The case was again considered by the Provincial Quality Control Board, under Section 11 of the
Drugs Act, 1976 in its 190th meeting held on 31-7-2018. Secretary PQCB informed the board the
subject case had already been disposed of with warning to the firm however report of the
inspection committee was awaited. Chief Drugs Controller Punjab (the inspection committee)
presented the above- mentioned inspection report and apprised the board that coating of tablets
was being performed in multiple cycles due to limited capacity of the coating pans. Resultantly
the coating was not uniform. This nonconformity was the possible reason for physical deformity
in tablets as reported by the Government Analyst vide above- mentioned test/ analysis. The
board agreed with the recommendations/ advice tendered by the inspection panel to the firm to
overcome this nonconformity.
The board after due diligence and deliberation on various aspects of the case and detailed
scrutiny of the inspection report unanimously decided to forward the Product Specific
Inspection (PSI) report to the Central Licensing Board (CLB) DRAP Islamabad through
Chief Executive Officer DRAP for information and necessary action as required under law.

The case was presented before the Registration Board in its 286th meeting on 16th
November, 2018 and the Board after perusing the record/ document of the instant case
deliberated the matter in depth and decided as under:
“to issue the show cause notice and personal hearing to the firm/ responsible
persons as provided by the provincial quality control board (PQCB), Lahore for
manufacturing and selling of substandard Losara-P 50mg tablets, Batch No. 9E-100,
Manufactured by M/s Aneeb Pharmaceutical, Lahore.”
No.03-86/2018-QC (286-RB) on 16th January 2019 but the firm didn’t submit their reply till to
date.
Case no. 06: REQUEST TO TRANSFER “NOT TO DISPOSE OF” STOCK FROM
PHARMACY NATIONAL INSTITUTE OF CHILD HEALTH (NICH).
The Federal Inspector of Drugs, DRAP Karachi (FID-V) has referred letter No.
ADMN/2018/4183/NICH dated 21st December 2018 received from the Director, National
Institute of Child Health (NICH) for shifting of stock of following medicine, that were ordered
not to dispose of under section 18(1) of the Drugs Act, 1976 on form-I, due to space constraints
at the premises of NICH pharmacy.
Name of B. Quantity Manufacturer Orders made Dated Reasons Extensi
Drug No. by on vide
DRAP
and
dated
1. Syp. D288 60mlx31000 Zanctok, FID-V 26-07-18 Substandard F. 13-
Zancpal Hyderabad (K) 49/201
8 QC
dated
29-08-
18
2. Syp. D281 60mlx22000 Zanctok, Addl. Director -do- Substandard Nil
Zancpal Hyderabad (K)
3. Inj. 157 2mlx31x25 Elite, Lahore -do- 07-03-18 Substandard Nil
Elitopine.
4. Inj. F-SI- Farmaceutics -do- -do- Substandard Nil
Ceuticsaxi 369 Karachi &
me Adulterated
5. Water F-1- 5mlx21734 Farmaceutics -do- -do- Nil
for Inj. 412 Karachi
6. Inj. 405 10mlx50Box Elite, Lahore -do- 05-03-18 Substandard Nil
Lignocain &
Adulterated
The FID-V, DRAP, Karachi informed that there is extension of period of orders not to dispose of
for drugs mentioned at serial from 3 to 6 above not received as yet despite of letters.
The FID-V, DRAP, Karachi further added that keeping in view of the difficulties of said institute
and space problems, it is proposed that the said stock may be shifted to another premises under
safe custody preferably at the premises of relevant manufacturers. It is therefore requested that:
i. Grant of necessary pending extension of said orders from CLB.
ii. Necessary permission of shifting stocks ordered not to dispose of from NICH to
another safe custody.
iii. Necessary permission for release of drug namely Elitopine Injection Batch No.157 as
appellate lab declared as standard quality vide its report No. 013-M/2018 dated 18th
July, 2018.
It is submitted that the product at serial No.1 was declared as of standard quality by the Central
Drug Laboratory, Karachi.
It is further submitted that products at serial No. 3 & 6 have been declared by the Appellate
laboratory, NIH, Islamabad as of standard quality vide their test report 013-M/2018 dated 18th
July, 2018 & 011-M/2018 dated 21st May, 2018 respectively.
Case No.07: CASE REFERRED BY PQCB PUNJAB REGARDING SUB-STANDARD
LEVAOX LIQUID MANUFACTURED BY M/S INTERVAC (PVT) LTD 18KM
LAHORE SHEIKHUPURA ROAD, SHEIKHUPURA.
The Secretary, PQCB, Punjab vide letter no. PQCB/R 202-209/2017 dated 05-11-2018 requested
for cancellation of registration of LEVAOX Liquid for Veterinary 1 liter manufactured by M/s
Intervac (Pvt.) Ltd., 18km Lahore Sheikhupura road, Sheikhupura.
Brief Facts of the Case:
Provincial Inspector of Drugs Aroop Town, Gujranwala reported that:
i. He, on 16-06-2017, inspected the medicine Store of Director Livestock Division, Aroop
Town, Gujranwala and took samples of 11 types of drugs on Form-4 for the purpose of
test and analysis.
ii. Eight out of these drugs samples after test/analysis, were declared substandard by
Government Analyst Drug Testing Laboratory, Faisalabad as detailed below:
Name of Batc Name of DTL Report DTL Report results

the Drug h Manufacturer TRA No. &
No. Date
Levaox LX- M/s Intervac Pvt Ltd TRA No. Analysis with specifications:
Liquid 1 276 18Km Lahore 10857/DTL
Liter Sheikhupura Road Dated: 18-07- Manufacturer’s specification
Sheikhupura 2017
Description:
Stated: Light yellow colored liquid.
Determined: Mustard colored liquid.
(Does not comply with specifications)
Label claim:
Each 100ml contains: Levamisol HCl B.P

1.50gm, Oxyclozanide B.P Vet 3.00gm
Identification: Levamisol and Oxyclozanide

identified.
Assay: Per 100ml of liquid:
Levamisole HCl:
Stated: 1.50gm
Determined: 1.5165gm
Percentage: 101.1%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 3.024gm
Percentage: 100.8%
Limit: 90-110%
Result: The sample is substandard as defined in

drugs Act, 1976.
Sheikhupura 2017
Description:
Label claim:


identified.
Levamisole HCl:
Stated: 1.50gm
Determined: 1.638gm
Percentage: 109.2%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 3.069gm
Percentage: 102.3%
Limit: 90-110%

drugs Act, 1976.
Liquid 1 18Km Lahore 10859/DTL
Liter 278 Sheikhupura Road Dated: 18-07- Manufacturer’s specification
Sheikhupura 2017
Description:
Label claim:


identified.
Levamisole HCl:
Stated: 1.50gm
Determined: 1.55gm
Percentage: 103.7%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 2.868gm
Percentage: 95.6%
Limit: 90-110%

drugs Act, 1976.
Sheikhupura 2017
Description:
Label claim:

identified.
Levamisole HCl:
Stated: 1.50gm
Percentage: 98.1%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 2.712gm
Percentage: 90.4%
Limit: 90-110%

drugs Act, 1976.
Sheikhupura 2017
Description:
Label claim:


identified.
Levamisole HCl:
Stated: 1.50gm
Determined: 1.461gm
Percentage: 97.4%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 2.73gm
Percentage: 91.0%
Limit: 90-110%

drugs Act, 1976.
Sheikhupura 2017
Description: Mustard colored liquid having
putrid smell contained in plastic bottle.
Label claim:


identified.
Levamisole HCl:
Stated: 1.50gm
Determined: 1.473gm
Percentage: 98.2%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 2.784gm
Percentage: 92.8%
Limit: 90-110%

drugs Act, 1976.
Sheikhupura 2017
Description: Mustard colored liquid having
putrid smell contained in plastic bottle.
Label claim:


identified.
Levamisole HCl:
Stated: 1.50gm
Percentage: 100.7%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 2.991gm
Percentage: 99.7%
Limit: 90-110%

drugs Act, 1976.
Sheikhupura 2017
Description: Mustard colored almost odorless
liquid contained in plastic bottle.
Label claim:


identified.
Levamisole HCl:
Stated: 1.50gm
Percentage: 100.3%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm
Determined: 2.94gm
Percentage: 98.0%
Limit: 90-110%

drugs Act, 1976.
iii. Store keeper of Medicine store of Director Livestock Division, Aroop Town Gujranwala
provided invoice/warranty No. 7420 dated 03-06-2017 of M/s Intervac Pvt Ltd Head office
113/3, Allama Iqbal Road, Ghari Shahu Lahore as a proof of its purchase.
iv. Warrantor portion of the drug sample and copies of the test reports of Drug sample were
sent to Invertac Pvt Ltd., with direction to explain their position and provide requisite
information in this regard. In response they requested for retest/analysis from appellate
laboratory, NIH, Islamabad.
v. Persuant to their request, the drug samples were sent to NIH, Islamabad from where the
drug samples have been declared substandard as detaile below:
Name of Batc Name of NIH report DTL Report results

the Drug h Manufacturer No. & Date
No.
Levaox LX- M/s Intervac Pvt Test Report Analysis with specifications:
Liquid for 276 Ltd 18Km Lahore No. 0305-
Veterinary Sheikhupura Road P/2017 dated Manufacturer’s specification
1 Liter Sheikhupura 07-12-2017
Description:
Mustard colored suspension contained in labeled
plastic bottle.
(Does not comply with manufacturer’s

specifications which states that Levaox liquid is
light yellow in color)
Assay:
Levamisole HCl:
Stated: 1.50gm/100ml
Determined: 1.523gm/100ml
Percentage: 101.52%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 106.91%
Limit: 90-110%
Result: The sample is substandard on the basis

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 102.94%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 103.46%
Limit: 90-110%

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 99.35%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 92.77%
Limit: 90-110%

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 98.69%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 103.77%
Limit: 90-110%

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 101.86%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 106.97%
Limit: 90-110%

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 102.44%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 102.32%
Limit: 90-110%

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 100.34%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 104.65%
Limit: 90-110%

of tests performed.
Description:

plastic bottle.

Assay:
Levamisole HCl:
Percentage: 102.2%
Limit: 90-110%
Oxyclozanide:
Stated: 3.0gm/100ml
Percentage: 102.55%
Limit: 90-110%

of tests performed.
vi. Copies of NIH test report were sent to M/s Intervac Pvt Ltd 18Km Lahore Sheikhupura
Road Sheikhupura with direction to explain their position and provide requisite information in
this regard but they failed to do so.
vii. In this way the above mentioned accused persons have contravened the provision of
section 23/27 of the Drugs Act, 1976 and Rules framed their under by the way of:
Manufacturing for sale/sale of substandard drugs and issuance of its false warranty
Show cause/personal hearing notice(s) issued to accused person(s)/petitioners
PREVIOUS PROCEEDINGS BY THE BOARD:

188TH MEETING HELD ON 28-06-2018:
Case was considered by the Provincial Quality Control Board, under section 11 of the Drugs
Act, 1976 in its 188th meeting held on 28-06-2018. Secretary PQCB appraised the Board that all
the accused persons were absent although letter of personal hearing were sent to them through
courier service. The Board after discussion decided to pend the case due to non appearance of
accused persons in best interest of justice. The Board further decided to provide another but final
opportunity of personal hearing to the accused persons. Personal hearing notice(s) issued to
accused person(s).
CURRENT PROCEEDING & DECISION BY THE BOARD:

Case was considered by the Provincial Quality Control Board, under section 11 of the Drugs Act,
1976 in its 189th meeting held on 12-07-2018. Secretary DQCB Gujranwala Miss Sonia Irshad
and Drug inspector Saleh Muhammad both were present along with original case record.
Secretary PQCB apprised the Board that show cause/personal hearing notice(s) was issued to the
accused persons through courier service. Counsel for the firm Mr. Talha Ahmad Khan Advocate
submitted that the sample was declared substandard by DTL Bahawalpur and NIH, Islamabad
merely on the basis of color. The drug complies chemical assay as well as all other tests
performed by both laboratories. He added that the CEO of the firm is in Peshawar and unable to
appear before the Board due to short notice. He requested to adjourn the case for the next date of
hearing.
The Board after detailed scrutiny of the case record, Report of DTL, Bahawalpur, report of NIH,
Islamabad and statement of the council of the firm observed that the same problem was observed
in all the batches of the product. In order to dig out the root cause of defect in production of the
said product there is dire need of product specific inspection. Therefore, the Board decided to
constitute a committee comprising of the following to conduct Product Specific Inspection (PSI)
of M/s Intervac Pvt Ltd 18Km Lahore Sheikhupura Road Sheikhupura and submit report within
fortnight for consideration by the Board.
1 Prof. Dr. Mahmood Ahmad
Member PQCB
2 Mr. Muhammad Munawar Hayat
Chief Drugs Controller, Punjab/Member

3 Area Drug Inspector Industries
Inspection report of M/s Intervac pharmaceuticals
Note: The production department was closed at the time of inspection due to maintenance of its
doors and will remain closed till 27-09-2018. This was informed by manufacturer to DRAP.
Premises:
The unit was established in 2005, total area is 59895 sq. ft. Production area and quality control for
products in question is on ground floor.
The product range includes Oral liquid Hormones, antibiotic powder, Dry powder bolus, oral
liquids.
Total Number of registered products is 125.
Staff.
Designation Current Previous
Chief Executive Officer Ishfaq Ahmad Ishfaq Ahmad
Director Hafiz Tanveer Hafiz Tanveer
Production manager Muhammad Qasim Aziz Muhammad Qasim Aziz
QC Manager Manzoor Hussain Manzoor Hussain
Warrantor Ishfaq Ahmad Manzoor Hussain & M Qasim Aziz
QA Manger Vivian Joy Vivian Joy
Products (List provided)
Background information:
Total 22 batches of Levaox Liquid 1 Litre were supplied to the Director Livestock Division
Gujranwala; 8 batches (LX-276, LX-277, LX-278, LX-279, LX-280, LX-281, LX-282, LX-283) were
declared substandard on the basis of Physical parameter i.e. change in color from light yellow to
Mustard. Batch Size is 2000L (2000 bottles).
Observations:
1. DTL Lahore declared 8 batches substandard and two with putrid smell, however assay was within
limits. On appeal for retest, NIH, declared the same result except any “Putrid Smell” remarks.
2. The preparation of Levaox Liquid IL (Oxyclozanide BP Vet + Levamisole HCL BP) is non-
pharmacopeial and no information regarding its brand leader could be retrieved.
3. On the inspection of Sample retain room of the manufacturer; it was observed that the batch
manufactured in OS/2017 was contained in clear plastic bottle; however, the batch manufactured in
04/2017 was contained in opaque plastic bottle. Similarly, the container for government supply
resembled Mineral water bottle, but off-white gallon shaped container was used for commercial
market.
4. Only one bottle was retained as retention sample. Also, the oldest batch that could be retrieved
from sample retention area was batch No.LX-98 manufacture in Jan/2017; whereas legal
requirement is to retain the sample for one year after it expires.
5. The retention samples were found of yellow colored.
6. The Hi-tech lab contained FTIR, HPLC, TOC and UV-Vis Spectrophotometer (single beam and
double beam).
7. The analysis method is In-house using Spectrophotometer, the assay record for Batch No.LX-283
was missing in Log Book.
8. Method Validation has been conducted in Jan/2013. In case of Oxyclozanide Validation; the
diluents used was methanol instead of acidified methanol as per standard analytical procedure.
Moreover, Linearity, Accuracy, Specificity, LOo, LOD were also missing from Validation
Documents. For Levamisole, the linearity curve was not straight (non-linear).
9. Identification of raw material is done by FTIR against the standard built-in-library of Agilent.
10. Accelerated and on-going stability studies have not been conducted for the batches in question.
11. The pharmacopeia I reference standards were not available and working standards were used
instead.
Batch Processing Record
1. SMR Record is available.
2. Testing Method is available but not validated.
3. QC retention samples are available (one unit only) for each batch.
4. Tartrazine is on yellow color; 0.600kg/2000Litre.
5. Batch mixing, Filling line and packing line clearances records are available.
6. In-Process QC tests performed.
7. Batch size 2000 Liter.
Conclusion:
Based upon the observation noted, record/BMR review and stability Study data observations, the
panel is of the opinion that change in color was might be due to primary packaging material; as the
firm is using inferior quality PET bottle (Polyethylene terephthalate) for government supply. Also,
the plastic of varying kind and quality is employed for commercial market and government supply,
and the firm has also not established stability studies for that packing material (PET).
Therefore, the panel recommends that the matter should be forwarded to the Registration board of
DRAP for cancellation/Suspension of registration of drugs on violation of condition of registration
of drug.
Personal hearing notice(s) issued to accused person(s).

PROCEEDINGS & DECISION BY THE BOARD:
Case was considered by the Provincial Quality Control Board, under section 11 of the Drugs Act,
1976 in its 194th meeting held on 18.10.2018. Drug Inspector briefed the Board about facts of the
case and requested for the permission for prosecution against the accused persons. Counsel for
the firm argued that the drug samples were declared substandard merely on the basis of physical
specification i.e. change in color while drug was complying to its chemical specification. He
added that tartrazine was being used as coloring agent in the formulation which is light sensitive
and should be protected from light. The change in color of liquid may be due to effect of light,
but there was not chemical degradation of product as assay of the product was within official
limits. He requested the Board for lenient view.
The Board, after detailed scrutiny of the record, inspection report of the firm, due deliberation
and detailed discussion observed that change in color might be due to primary packaging
material; as the firm was using plastic bottles of varying kind and quality for packaging. The
drug was supplied to government in inferior quality PET bottle (Polyethylene terephthalate).
Moreover, the firm has also not established stability studies for that packing material (PET).
Keeping in the view of foregoing facts of the case the Board decided to grant permission for
prosecution against the following accused persons in the Drug Court.
i. M/s Intervac Pvt Ltd 18Km Lahore Sheikhupura Road Sheikhupura through its Chief
Executive Ashfaq Ahmad Khan.
ii. Ashfaq Ahmad Khan Chief Executive
iii. M Qasim Aziz Production Incharge/Warrantor
iv. Manzoor Hussain Quality Control Incharge/Warrantor
Of M/s Intervac Pvt Ltd 18Km Lahore Sheikhupura Road Sheikhupura for the offences
of
a. Manufacturing for sale/sale of substandard drugs.

b. issuance of its false warranty.
The board further decided to recommended registration board, Drug Regulatory Authority of
Pakistan for cancellation of registration of Levaox liquid for veterinary 1 liter manufactures M/s
Intervac Pvt. Ltd., 18-KM Lahore Sheikhupura Road, Sheikhupura.
Item No.V Any other item with the permission of the Chair

Agenda For 288th Meeting of Registration Board

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Agenda For 288th Meeting of Registration Board

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AGENDA FOR 288th MEETING OF REGISTRATION BOARD

TO BE HELD ON 14th & 15th FEBRUARY, 2019

Item Detail of Item Pages

 Import & Vet. 828-849

 Post Registration-I 850-855

 Post Registration-II 856-874

Drug Regulatory Authority of Pakistan

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |1

Submitted for confirmation of Registration Board, please.

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |2

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |3

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |4

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |5

FDA review of quinolones

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |7

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |8

The Board in 278th meeting decided as under:

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) |9

c) Tranexamic acid Capsule 500mg

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 10

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 11

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 12

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 13

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 14

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 15

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 16

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 18

Composition Dy No. 1068, 30-06-2014, Rs.20000/-

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 20

Decision of previous meeting of RB Deferred for:

Composition Each capsule contains:

Composition Each Capsule Contains

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 22

d) Propyphenazone 175 mg / Caffeine Anhydrous 25 mg sugar coated tablet

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 24

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 25

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 27

Type of Form Form 5

Type of Form Form 5

Type of Form Form 5

Type of Form Form 5

Type of Form Form 5

Type of Form Form 5

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 41

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 43

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 45

Remarks of the Evaluator4 Shelf life of 18 months with packaging

Remarks of the Evaluator4 Shelf life of 18 months with packaging

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 47

Remarks of the Evaluator4

Remarks of the Evaluator4

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 48

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 51

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 53

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 54

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 56

Agenda for 288th Meeting of Registration Board (14-15 February, 2019) | 59

Remarks of the Evaluator  Revision in master formulation Sodium d pantothenate