Final Minutes 320 RB

MINUTES OF 320th MEETING OF REGISTRATION BOARD
HELD ON 29th-31st AUGUST, 2022
*=*=*=*=*
Item Detail of Item Pages

No.
I. Confirmation of Minutes of 319 meeting of RB 2-3
II. Division of Pharmaceutical Evaluation & Registration --------------
Pharmaceutical Evaluation Cell (PEC) --------------------------------- 3-1331
Registration-I Section ----------------------------------------------------- 1332-1442
Registration-II Section ---------------------------------------------------- 1443-1465
Post Registration-I Section ----------------------------------------------- 1466-1478
Post Registration-II Section ---------------------------------------------- 1479-1482
Import & Vet-I Section --------------------------------------------------- 1483-1557
Import & Vet-II Section -------------------------------------------------- 1558-1595
RRR Section ---------------------------------------------------------------- 1596-1621
III. Division of Biological Evaluation & Research 1622-1732
IV. Division of Quality Assurance & Laboratory Testing 1733-1762
V. Additional Agenda 1763-1866
Minutes of 320th meeting of Registration Board (29th-31st August, 2022) |1

320th meeting of Registration Board was held on 29th, 30th & 31st September, 2022 in the
Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was
chaired by Dr. Obaidullah, Chairman Registration Board DRAP. The meeting started with
recitation of the Holy Verses.
Dr. Obaidullah, Chairman Registration Board apprised the Board regarding appointment
of newly appointed Secretary Registration Board Ch. Zeeshan Nazir Bajar, after the recent
promotions within DRAP. All the Board members welcomed newly appointed Secretary
Registration Board and hoped that their presence in Registration Board will help in efficient
working of the Board. The Board also acknowledged the services of Ex-Secretary, Registration
Board Mr. Abdullah and appreciated his commendable efforts for efficiently conducting the
proceedings of Board.
Following members attended the meeting:
1. Ch. Zeeshan Nazir Bajar, Additional Director (BE&R/PE&R), DRAP. Member/

Secretary
2. Lt.Gen.(R) Prof. Dr. Karamat A. Karamat (HI-M.SI-M), Former Member
Surgeon General Pakistan.
3. Maj. Gen. (R) Dr. Tahir Mukhtar Sayed, Inspector General (Hospitals), Member
Fauji Foundation, Rawalpindi
4. Dr. Qurban Ali, Ex-Director General, National Veterinary Laboratories, Member
Islamabad
5. Ms. Aisha Irfan, Additional Director, Biological Evaluation & Research Member
Division, DRAP
6. Mr. Iftikhar A. Choudhary, Hospital Pharmacist, Lahore Member
7. Mr. Muhammad Aslam, Deputy Draftsman-I, Ministry of law & Justice, Member
Islamabad.
8. Mr. Ijaz Alvi, Director, DTL, Rawalpindi Member
9. Dr. Imran Khan, Director, DTL, Peshawar Member
10. Mr. Akhtar Abbas Khan, Representative of QA&LT Division Member
Mr. Nadeem Alamgir (Pharma Bureau), Mr. Ali Raza & Mr. Jalal (PPMA) and Mr. Ziaulhaq
(PCDA) attended the meeting as observers.
Director, BE&R was assisted by respective Add. Director and Assistant Directors for
presentation of the agenda.
Item No. I: Confirmation of Minutes of 319th meetings of Registration Board.
319th meeting of Registration Board was held on 11th August, 2022. The draft minutes of
Registration Board were circulated among the members of Board on 25th August, 2022 with the
request for perusal/approval/comments (if any) by 26th August, 2022 at 10:00am. All members
agreed the draft minutes.

Accordingly, fair minutes were processed to Chairman, Registration Board for
perusal/approval. After approval from Chairman Registration Board, fair minutes of 319th meeting
of Registration Board were circulated among concerned divisions/sections for implementation.
Decision: Registration Board confirmed the minutes of 319th meeting.
Item No. II Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell (PEC)
Sr. No Name of Evaluator Title

1. Mr. Farooq Aslam Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Dr. Sidra Khalid Evaluator PEC-VII
8. Dr. Hanif Ullah Evaluator PEC-IX
9. Dr. Farhadullah Evaluator PEC-XI
10. Mr. Shahid Nawaz Evaluator PEC-XIII
11. Mr. Ahsan Hafiz Evaluator PEC-XIV
12. Mst. Saima Evaluator PEC-XV
13. Mr. Akbar Ali Evaluator PEC-XVI
14. Mr. Zia Ullah Evaluator PEC-XVII
15. Mr. Muneeb Ahmed Cheema Evaluator PEC-XVIII
16. Mr. Sarfraz Nawaz Evaluator PE&R

Case No. 1: Applications submitted on Form 5 / 5-D requiring submission of stability
data
It is submitted that various applications were received on Form 5 / 5-D which requires submission
of stability study data for further processing. The list of such applications is available on official
website of DRAP at https://www.dra.gov.pk/e-services/applications-for-pharmaceutical-drugs/.
The stability study data for these applications is not yet submitted.
Decision: Registration Board deliberated the matter in detail and observed that these
applications are pending for submission of stability data/product development data by the
applicants since many years. Keeping in view the pendency, the Board deliberated the
matter in detail and also took opinion of PPMA and then decided that the firms shall initiate
the product development and stability studies of submitted applications and intimate to
Pharmaceutical Evaluation Cell (PEC) regarding procuremne of raw material, initiation of
product development and initiation of stability studies, by 31st December 2022. For all those
applications for which Pharmaceutical Evaluation Cell will not receive any intimation
regarding initiation of product development and stability studies, will be placed before the
Board for decision.
Case No. 2: Review of Reference status of Cephradine for Injection:

Registration Board in its various meetings deferred the cases of Cephradine for Injection due to
discontinued status of the said product by USFDA and non-availability of evidence of approval in
other reference regulatory authorities.
Recently, the firm M/s GSK, Pakistan has submitted that they have contacted US FDA to seek
confirmation on the reason of discontinuation of Cephradine (Velosef) Injections in US. They
were advised to refer “US Federal Register” for the reason of discontinuation, wherein it has been
declared that “Cephradine (Velosef) Injections were discontinued by the manufacturer itself based
on marketing reasons and that’s why the dispensing of stocks was also allowed to continue till
depletion of inventories or expiry of the stocks.”
The claim of the firm has been verified from Federal Register- The daily Journal of United States
Government which notified that the Food and Drug Administration (FDA) has withdrawn the
approval of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) listed
in table below. The notification is elaborated as below:
“The holders of the applications listed in the table have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of the applications
under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by
their requests, waived their opportunity for a hearing. Withdrawal of approval of an application
or abbreviated application under § 314.150(c) is without prejudice to refiling.”
NDA Withdrawal
No./ANDA Drug Applicant date
No.
Bristol-Myers Squibb Co., P.O. Box April, 29,
NDA/50-501 Velosef Injection.
4000, Princeton, NJ 08543-6837. 2002
Cephradine Powder for Bristol-Myers Squibb Co., P.O. September
ANDA/061975
Injection Box 4000, Princeton, NJ 08543. 7, 2018.
“Therefore, approval of the applications listed in the table, and all amendments and
supplements thereto, is hereby withdrawn as of September 7, 2018. Introduction or delivery for
introduction into interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in inventory on September 7, 2018
may continue to be dispensed until the inventories have been depleted or the drug products have
reached their expiration dates or otherwise become violative, whichever occurs first.”

Hence it is evident from the above cited reference that the formulation of Cephradine injection
had been discontinued only due to marketing reasons and no issues related to safety & efficacy
have been reported by US FDA, because had there been any safety or efficacy issue, US FDA
would have not allowed the dispensing of available stocks till the expiry or depletion of the
inventory.
It is also pertinent to mention that other dosage forms of Cephradine i.e., Capsule & dry powder
suspension are also available as of today in several reference regulatory authorities.
Following are the official website links for regulatory authorities:
Sr. Website links Regulator Comments
No. y
authorities
1 https://cekbpom.pom.go.id//home/produk/pnkk3s5d Indonesian Confirms the registration
hi2trjufaigklkt0qr/all/row/10/page/0/order/4/DESC/ Food and of Cephradine 1gm/vial.
search/5/cefradine. Drug
Supervisor
y Agency
2 https://www.drugoffice.gov.hk/eps/do/en/consumer Pharmacy Confirms the registration
/search_drug_database2.html & of Cephradine for Inj
Poisons Bo 500mg.
ard of
Hong
Kong.
3 http://dgdagov.info/index.php/registered- Banglades Confirms the registration
products/allopathic h Govt. -
of Cephradine 250mg/vial,
DGDA
500mg/vial,
1gm/vial.
4 https://www.federalregister.gov/documents/2018/0 Federal Confirms that Cephradine
8/08/2018-16985/fougera-pharmaceuticals-inc-et- Register of discontinued based on
al-withdrawal-of-approval-of-27-abbreviated-new- US Govt. marketing reasons only.
drug-applications. Hence allowed to dispense
till the inventory deplete or
stocks expired.
5 https://www.fda.gov/safety/recalls-market- FDA The non-availability of
withdrawals-safety-alerts. Safety cephradine in said register
Alerts confirms that there is no
safety issue for market
withdrawals.
Decision: Registration Board deliberated the matter in detail and acknowlwdged the fact
that the “Cephradien injection” has not been withdrawan from US market due to safety &
efficacy reasons as evident from the above cited notice published in US Federal Register.
Hence, Registration Board decided to consider pending registration applications in the light
of aforementioned position.
Case no. 03 Borrowing of APIs for performing Product Development, R&D & stability
Testing:
DRAP Authority in its 133rd and 134th meeting considered the request of PPMA regarding
borrowing of APIs for performing Product Development, R&D & stability Testing. The Authority
in its 134th meeting decided as under:
The Authority reviewed its earlier decision taken in its 133rd meeting and decided as follows:
“The Authority deliberated that for product development / stability studies, the manufacturer need
to purchase drug substance from a reliable source, however, in extraordinary circumstances
beyond the control of manufacturer, the Authority acceded to the request of Pakistan
Pharmaceutical Manufacturers Association (PPMA) to allow borrowing, except controlled drugs,
the requisite quantity of drug substance for product development / stability studies only to fulfill
pre-requisite for submission of Form 5-F (CTD) from a licensed manufacturer having legitimate
purchase evidence. However, all requirements of quality and traceability would be applicable in
such cases and will be the responsibility of the borrower of the material. Further, the products so
manufactured in NO case shall be allowed for commercial sale.”
Decision: Registration Board considered decision of Authority and requested for guidance
regarding processing of cases for borrowing of drug susbtances/materials for
product development / stability studies of drug products on following points:
a. Parameters to determine “extraordinary circumstances beyond the control of
manufacturer”.
b. Whether borrowing will be permisable from manufacturer having registration of
the products (containing same material) or will also be permisable for materials
imported for experimental/ product development purposes by another
manufacturer.
c. Status of material after commercial import by registration holder (borrower).
On the basis of above cited decision of Board, instant case was referred for seeking guidance from
the Authority. Subsequently Authority in its 140th meeting held on 28-29th June, 2022 has decided
as under:
“The Authority, keeping in view of practical difficulties in implementation as highlighted by the

Registration Board, reviewed its earlier decision taken in its 134th meeting held on 29th April,
2022, as under:
“The Authority deliberated that for product development / stability studies, the manufacturer need
to purchase drug substance from a reliable source. Therefore, the Authority acceded to the request
of Pakistan Pharmaceutical Manufacturers Association (PPMA) to allow borrowing the requisite
quantity of drug substance, except controlled drugs, for product development / stability studies
only to fulfill pre-requisite for submission of registration dossier from a licensed manufacturer
having legitimate purchase evidence. However, all requirements of quality and traceability would
be applicable in such cases and will also be the responsibility of the borrower of the material.
Further, the products so manufactured in NO case shall be allowed for commercial sale.”
Discussion & Decision:

Registration Board adopted the above cited decision of Authority and considered following cases:
1. Name, address of Applicant / M/s. SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off
Marketing Authorization Holder Hub River Road, S.I.T.E. Karachi.
Name, address of Manufacturing M/s Sami Pharmaceuticals (Pvt) Ltd. F-95, Off Hub
site. River Road, S.I.T.E. Karachi.
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical ☐ Domestic sale
product ☐ Export sale
☒ Domestic and Export sales
Dy. No. and date of submission Dy. No. 19160 dated :08-07-2021
Details of fee submitted PKR 30,000/-: Deposit slip #887056162198
PKR 120,000/-: Deposit slip #12835367 dated:20-
01-2022

The proposed proprietary name /
Mevulak MR 200mg Capsule
brand name
Strength / concentration of drug of Each Capsule contains:
Active Pharmaceutical ingredient Modified release Mebeverine HCl Pellets
(API) per unit Equivalent to Mebeverine HCl ……. 200mg
(Innovator’s Specifications)
Pharmaceutical form of applied
Modified Release Capsule
drug
Pharmacotherapeutic Group of Synthetic anticholinergics
(API) ATC Code: A03AA04
Reference to Finished product
Innovator’s Specifications
specifications
Proposed Pack size 10’s, 20’s, & 30’s
Proposed unit price As per SRO
The status in reference regulatory Colofac® MR. Modified release capsule by M/s
authorities MHRA Approved.
For generic drugs (me-too status) Mebever MR 200mg Capsule by M/s Getz
Pharma,Registration No. 050747
GMP status of the Finished product GMP Certificate issued date 11-08-2020 on the basis
manufacturer of inspection conducted on 28-08-2019
Name and address of API M/s RA Chem Pharma Limited (FDF)
manufacturer. Plot No: A-19/C, A-23A 7 A-23B, Road No0 18,
IDA Nancharam, Nancharm Village , Uppal
Manda, Medchal- malkajgiri district, Hyderabad,
Telegana, India.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD
Summary) template. Summarized information related to
nomenclature, structure, general properties,
solubilities, physical form, manufacturers,
description of manufacturing process and controls,
specifications, analytical procedures and its
validation, batch analysis and justification of
specification, reference standard, container closure
system and stability studies of drug substance and
drug product is submitted.
Module III (Drug Substance) The firm as submitted detail of nomenclature,
structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing
process and controls, specifications, analytical
procedures and its validation, batch analysis and
justification of specification, reference standard,
container closure system and stability studies of drug
substance
Stability studies of Drug substance Stability study conditions:
Real time: 30°C ± 2°C / 75% ± 5%RH for 36 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 06
months
Batches:(MBPJ16007,MBPJ16008,MBPJ16009,)
Module-III (Drug Product): The firm has submitted detail of manufacturers,

impurities, individual impurity and total impurity,
specifications, analytical procedure (including
dissolution testing at acidic and buffer medium) and
its validation studies, batch analysis and justification
of specification, reference standard, container
closure system and stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical Equivalence have been established
comparative dissolution profile against the Competitor that is Mebever MR® 200mg
Tablets by M/s Getz Pharma by performing quality
tests (Appearance, average weight, Assay,
Dissolution, impurity profiling, Microbiological
limit test ).
CDP has been performed against the same brand that
is A Mebever MR® 200mg Tablets by M/s Getz
Pharma in Acid media (pH 1.2-4.5) & Phosphate
Buffer (pH 6.8). The values for f1 and f2 are in the
acceptable range.
Analytical method Method validation studies have submitted including
validation/verification of product linearity, accuracy, precision
(including intermediate precision, Repeatability),
Robustness, specificity
STABILITY STUDY DATA
Manufacturer of API M/s RA Chem Pharma Limited (FDF)
Plot No: A-19/C, A-23A 7 A-23B, Road No0 18, IDA Nancharam,
Nancharm Village , Uppal Manda, Medchal- malkajgiri district,
Hyderabad, Telegana, India.
API Lot No. DMBPJ19049
Description of Pack
(Container closure Alu-Alu blister
system)
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 06th months
Accelerated: 6th months
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 2500 Capsules 2500 Capsules 2500 Capsules
Manufacturing Date 07-2020 07-2020 07-2020
Date of Initiation 14-07-2020 14-07-2020 14-07-2020
No. of Batches 03
Administrative Portion
1. Reference of previous approval of Reference of our last onsite panel inspection for
applications with stability study data instant dosage form conducted during last two years
of the firm (if any) i.e. DELANZO DR (Dexlansoprazole) 30mg &
60mg Capsules which was presented in 281th
meeting of the registration board & hence approved
& registered by registration board

Date of inspection: 02nd April, 2018.The inspection
report confirms following points
• The HPLC software is 21CFR Compliant
• Audit trail on the testing reports is available.
• Adequate monitoring and control are available
for stability chamber. Chambers are controlled
and monitored through software having alarm
system for alerts as well.
• Related manufacturing area, equipment,
personnel and utilities are GMP compliant.
2. Approval of API/ DML/GMP Copy of DML for M/s RA Chem Pharma Limited
certificate of API manufacturer (FDF) (License No# 23/RR/AP/2007/F/R/CC,
issued by concerned regulatory Dt:07/07/2013) issued by Drug Control
authority of country of origin. Administration Government of Telegana, valid upto
26-10-2025 is submitted
3. Documents for the procurement of Detail of Loan material from S.J & G Fazul Elahie
API with approval from DRAP (in (Pvt.) Karachi along with the Copy of form 3, form
case of import). 7 & commercial invoice (Invoice# RATG/19-
20/812 02-03- 2020 with received quantity i.e. 250
kg) for the purchase Mebeverine HCl SR Pellets by
RA CHEM PHARMA LIMITED (FDF Division)
with attestation of DRAP dated: 13 -02- 2020
4. Data of stability batches will be Submitted
supported by attested respective
documents like chromatograms,
Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC Submitted.
software 21CFR & audit trail reports
on product testing
6. Record of Digital data logger for Submitted
temperature and humidity
monitoring of stability chambers
(real time and accelerated)
Remarks of Evaluator(II):
Fee submitted PKR 120,000/-: Deposit slip #12835367, Dated: 20-01-2022
S.No Section Shortcomings Communicated Reply

1. 3.2.P.8 Clarify why you take loan of Mebeverine HCL pellets of good
Pellets from S.J & G Fazul Elahie quality could be sourced from good
(Pvt.) Karachi instead of purchase Indian manufacturers at reasonable
from direct pellets maufacturer rates.
In order to conduct Stability Studies,
we requested few manufacturers to
supply required quantity of
Mebeverine Hcl SR pellets to which
they agreed.
Unfortunately no Courier company
was willing to lift sample quantity from
India for delivery to us; copies of
emails exchanged with them are
annexed herewith.

M/s S.J. & G Fazul Ellahie Pvt. Ltd.
Karachi fortunately had sufficient
stock of imported Mebeverine Hcl
pellets and were willing to provide
required quantity on loan.
We accordingly obtained required
quantity on loan from them.
th
Decision of 316 meeting: Deferred for further deliberation regarding regarding use of drug
substance pellets by M/s Sami Pharmaceuticals (Pvt.) Ltd, for the manufacturing of stability
batches, which had been procured and imported by M/s S.J. & G Fazul Ellahie Pvt. Ltd. Karachi.
Firm’s response: Firm has submitted as under:
• Import of all material from India was banned vide SRO. 927 (I)/2019. dated 09-08-2019
issued by Ministry of Commerce & Textile however it was effectively operational only after
Oct 2019 when DRAP Legal Affairs Division, vide its letter dated 17-10-2019 , requested
Ministry of Commerce to issue the following clarification: (Annex A)
The words “therapeutic products” and “therapeutic good” carry the same meaning
• Due to this reason, all courier companies and postal authorities were not accepting any type
of post and mail including letter, parcels and documents; copies of emails exchanged with
FedEx, TCS(UPS) are annexed herewith (Annex B)
• We contacted many leading USFDA, MHRA and EDQM Certified manufacturers of APIs
and Pellets in India from whom we were procuring the material since last 10 years for
obtaining samples but due to COVID surge in India, no courier service was accepting samples
for delivery to Pakistan (Annex C)
• Having been left with no other option, the material was received on “Loan” against an
Understanding; as stated on Memo attached; from an established manufacturer viz., M/s. S.J.
&G. Fazul Ellahie (Pvt.) Ltd. Karachi who had legally imported these Pellets from the same
source viz., RA Chem Pharma Ltd. It was assured to them that on obtaining drug
registration, we will import commercial quantities from the same source and then return
the material received on loan (Annex D)
• We have learnt that the DRAP Authpority has now allowed to take the material on loan as per
following criteria:
Material can be procured from one manufacturer to another for
R&D purpose and commercial consignment then shall be obtained from the
same source i.e. API supplier
Hence, in the light of above, it is earnestly requested to consider our case for favorable decision.
Moreover, firm has submitted memorandum of understanding between M/s Sami Pharma. & M/s
S.J&G Fazul Ellahe regarding loan and return of the said drug substance. Firm has also submitted
regarding use of the borrowed material for R&D purpose only.
Decision: Deferred till decision of Authority on borrowing of APIs for performing Product
Development, R&D & stability Testing.
Decision of 320th meeting: Approved with Innovator’s specifications.
• Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months as per the
commitment submitted in the registration application.
• Manufacturer will perform process validation of first three batches as per the
Minutes of 320th meeting of Registration Board (29th-31st August, 2022) | 10

2. Name, address of Applicant / M/s Nabiqasim Industries Pvt Ltd. 17/24,
Marketing Authorization Holder Korangi Industrial Area, Karachi, Pakistan
Name, address of Manufacturing site. M/s Nabiqasim Industries Pvt Ltd. 17/24,
Korangi Industrial Area, Karachi, Pakistan
☐ Importer
☐ Is involved in none of the above (contract
giver)
GMP status of the firm GMP certificate issued on basis of inspection
conducted on 19-09-2020
Evidence of approval of manufacturing Firm has submitted copy of DML, declaring
facility “Ear drop/Topical solution” section, whereas
submitted GMP certificate mentions the
“Cream/Ointment/Lotion section.”
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
Dy. No. and date of submission Dy. No.10088 dated 31-03-2021
Details of fee submitted Rs.20,000/- dated 31-003-2021
The proposed proprietary name / brand Lidogel 2% Jelly
name
Strength / concentration of drug of Each ml Contains:
Active Pharmaceutical ingredient (API) Lidocaine HCl…….…20mg
per unit
Pharmaceutical form of applied drug Topical spray solution
Pharmacotherapeutic Group of (API) Local Anaesthetic Jelly Sterile.
For topical application only ATC Code:
N01BB02
Reference to Finished product USP specification
specifications
Proposed Pack size 1gm x 1’s
Proposed unit price MRP as per PRC
The status in reference regulatory Xylocaine 2% Gel (Lidocaine HCl 2%) is
authorities registered and being marketed by OAK
Pharms, USA (FDA approved).
For generic drugs (me-too status) M/s Barrett Hodgson Pakistan (Pvt) Ltd.,
b. Brand Name: Xylocaine 2%
c. Strength: 2% Jelly
Reg. No.: 009315
Name and address of API manufacturer. M/s Gufic Group Testing Laboratories.
N.H.No.8, Near Grid AT & PO Kabilpore-39G
424, Navsari, Gujrat, India.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD
template. Firm has summarized information
related to nomenclature, structure, general

properties, solubilities, physical form,
manufacturers, description of manufacturing
process and controls, impurities, specifications,
analytical procedures and its validation, batch
analysis and justification of specification,
reference standard, container closure system
and stability studies of drug substance and drug
product.
Module-III Drug Substance: Firm has submitted detailed data for drug
substance data related to nomenclature,
structure, general properties, solubilities,
physical form, manufacturers, description of
manufacturing process and controls, impurities,
specification, reference standard, container
closure system and stability studies of drug
substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3
(Conditions duration of Stability studies) batches of drug substance at both accelerated as
well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75%
± 5% RH for 6 months. The real time stability
data is conducted at 25°C ± 2°C / 60 ± 5% RH
for 6 months.
Module-III Drug Product: Firm has submitted data of drug product
including its description, composition,
pharmaceutical development, manufacture,
manufacturing process and process control,
process validation protocols, control of
excipients, control of drug product,
specifications, analytical procedures, validation
of analytical procedures, batch analysis,
justification of specifications, reference
standard or materials, container closure system
and stability.
Pharmaceutical Equivalence and Pharmaceutical Equivalence Studies against the
Comparative Dissolution Profile reference product of “Xylocaine jelly 2%” of
M/s Barret Hodgson has been submitted.
Analytical method Firm has submitted verification studies of the
validation/verification of product drug substance and the drug product.
Stability studies Firm has submitted stability studies data of
three batches at both accelerated and long-term
conditions.
Manufacturer of APIs M/s Shandong Boyuan Pharmaceutical Co., Ltd. Qiangjin Street,
Jibei Economic Development Zone, Jinan, Shandong, China.
API Lot No. 190305TA
Description of Pack 15gm Aluminium tube with an applicator cone in a unit carton.
(Container closure
system)

Real time: 6 months
Time Period
Accelerated: 6 months
Accelerated: 0, 3, 6 (Months)
Frequency
Batch No. L001DS01 L001DS02 L001DS03
Batch Size 01 ltr. 01 ltr. 01 ltr.
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr.# Documents To Be Provided Status
1. Reference of previous approval of
applications with stability study
--
data of
the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP certificate (Certificate# 19081523)
certificate of API manufacturer issued by Food & Drug Administration Gujarat,
issued by concerned regulatory valid upto 06-08-2022.
authority of country of origin.
3. Documents for the procurement of Copy of commercial invoice issued in the name of
API with approval from DRAP (in M/s Surge Laboratories (Pvt.) Ltd. attested by AD
case of import). I&E DRAP, Lahore has been submitted for import
of Lidocaine HCl
Date of
Quantity
Invoice No. approval
Imported
by DRAP
NBEXBD2021000188 600Kg 10-11-2020
4. Data of stability batches will be
Firm has submitted data of stability batches along
with batch manufacturing record and analytical
record.
data sheets etc.
5. Compliance Record of HPLC
Firm has submitted audit trail reports on product
software 21CFR & audit trail
testing.
reports on product testing.
6. Record of Digital data logger for
Firm has submitted Record of Digital data logger for
temperature & humidity
temperature & humidity monitoring of stability
chambers (real time and accelerated).
(real time and accelerated).
Section Observation Firm’s response
2.3 Table for literature references for the Submitted.
drug substance & drug product has not
been submitted.
2.3. S.1.2 Submitted molar mass is not correct. Corrected molar mass has now been
submitted.
2.3. S.3.2 List of impurities is as per the USP List of impurities as per BP monograph
monograph for Lidocaine HCl, has now been submitted.
whereas API manufacturer has
declared the API of BP grade.
2.3. S.4.2 This section declares that “Lidocaine Firm has submitted that the drug
hydrochloride is tested as per the test substance manufacturer has declared
procedures described in the US

Pharmacopoeia”, whereas section the drug substance of standard quality
2.3.S.4.1 declares the API of BP as per both USP & BP monograph.
standard.
3.2.S.4.3 Analytical Method Verification studies Submitted for the titration method as
including specificity, accuracy and per BP monograph
repeatability (method precision)
performed by the Drug Product
manufacturer shall be submitted.
3.2.S.4.4 Submit analytical record for the batch Firm has submitted analytical record for
analysis of drug substance performed the analysis of drug substance according
by the M/s Nabiqasim. to which analysis has been performed as
per BP monograph by way of
potentiometric titration.
3.2.P.1 Clarification shall be submitted Frim has submitted that the label claim
regarding label claim whether it is in is as per innovator i.e., %age w/v”
term of “%age w/w” or “%age w/v”.
3.2.P.2.1.2 Quantities of preservatives used in Firm has referred to the literature from
formulation shall be justified for per Hand book of pharmaceutical
unit dose with reference to the relevant excipients and reference limits from
guidelines/standards. FDA IID database.
3.2.P.5.1 Test for content of antimicrobial Firm has submitted that preservative
preservative & efficacy of efficacy test, preservative content test,
preservative, as recommended by ICH initial testing and 01-month stability
Q1 (R2) guidelines & USP chapter testing and has submitted reports now.
<51>, has not been included in the Firm has also submitted revised
finished product specifications. You specifications and finished drug product
are advised to submit justification in analytical procedure including the test
this regard. for Methyl paraben & Propyl paraben.
3.2.P.8 • Submitted commercial invoice • With reference to the subjected
attested by AD DRAP I&E Karachi query, we would like to inform you
has been isuued in the name of M/s that “M/s Surge Laboratories (Pvt.)
Surge Laborartories (Pvt.) Ltd. Ltd” is the sister company of “M/s
Justification shall be submitted in Nabiqasim Industries (Pvt.) Ltd.”
this regard. • Commercial invoice of Lidocaine
• Test for content of antimicrobial HCl attested by AD DRAP issued in
preservative & efficacy of the name of M/s Surge Laboratories
preservative, as recommended by (Pvt.) Ltd because material is
ICH Q1 (R2) guidelines, has not imported by Surge Laboratories
been performed during stability (Pvt.) Limited.
studies. You are advised to submit • Lidocaine HCl supplier to
justification in this regard. “Nabiqasim Industries (Pvt.) Ltd.”
• A white paper titled “Support for is its sister company “Surge
Title 21 CFR Part 11 …..” has been Laboratories (Pvt.) Ltd”.
submitted from “Agilent open Lab” • Moreover, testing of API and
under the heading of “Compliance stability batches conducted by M/s
record of HPLC software 21 CFR Nabiqasim Industries (Pvt.) Ltd. and
& audit trail report on product reports are enclosed for ready
testing”, whereas submitted reference.
chromatograms establish that the • Firm has submitted that preservative
analysis has been performed on efficacy test, preservative content
Schimadzu HPLC. test, initial testing and 01-month
stability testing and has submitted
reports now. Firm has also
submitted revised specifications and
finished drug product analytical

procedure including the test for
Methyl paraben & Propyl paraben.
• Firm has now submitted Audit trail
reports.
• You are advised to submit scientific rationale for • We would like to inform that as per
claiming USP specifications for finished drug dosage form definition in USP
product while the Drug substance used is of BP chapter (1151). Jelly can also be
specifications. covered in the definition of Gels and
• Clarification shall be submitted that in which can be manufactured in Semi solid
section applied product will be manufactured (Gel) manufacturing area.
along with the evidence of approval of required • Nabiqasim has dedicated semi solid
manufacturing facility/section for applied manufacturing area for cream,
product, from the Licensing Division of DRAP. ointment and gel manufacturing.
Nabiqasim has also registered gel
dosage form i.e. Chlorhexidine
Gluconate Gel for which product
specific inspection has been
conducted on 27.10.2020. Report of
this inspection is attached for your
ready reference.
• The Panel has report as follows
against the query of required
manufacturing facility for
manufacturing and filling of gels:
“Firm has well equipped area for
manufacturing of ointment, creams
and gels. Along with creams and
ointments one gel preparation
(Acnicot Gel, Reg. No. 080660) is
already manufactured in this area.
Firm has already applied to the
licensing division for the inclusion
of gel in their layout vide letter No.
NQIL/DRAP/06-20/027, dated 10-
06-2020.”
th
Decision of 316 meeting: Registration Board deferred the case for further deliberation
regarding use of drug substance by M/s Nabiqasim Industries (Pvt.) Ltd., for the manufacturing
of stability batches, which had been procured and imported by M/s Surge Laboratories (Pvt.)
Ltd.
Firm’s response: We in this regard, would like to clarify that since M/s. Surge Laboratories (Pvt)
Ltd., Sheikhupura is our associated company which is under the control of common management.
As M/s. Surge Laboratories is importing API “Lidocaine HCl USP” for the manufacturing of
their registered drug “Lidoject 2% Injection” Reg # 057348. In order to save time, we had taken
a loan of 15Kgs “Lidocaine HCl USP” from M/s. Surge Laboratories to conduct stability for our
applied drug “Lidogel Gel 2%”. Firm has submitted following documents.
• Mutual agreement between M/s Nabiqasim and M/s. Surge Laboratories.
Undertaking.
Decision of 320th meeting: Approved.
3. Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd. Plot No. 384,
Marketing Authorization Holder Sunder Industrial Estate, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd.
Plot No. 384, Sunder Industrial Estate, Lahore
☐ Importer
GMP status of the firm GMP certificate issued on 17-07-2020
Evidence of approval of manufacturing Firm has submitted copy of section approval letter
facility dated 24-06-2019 which specifies Ophthalmic
general section.
☐ Export sale
Dy. No. and date of submission Dy. No 398 dated 05-01-2022
The proposed proprietary name / brand Dorzil Eye drop
name
Strength / concentration of drug of Active Each ml contains 22.26 mg of Dorzolamide
Pharmaceutical ingredient (API) per unit hydrochloride equivalent to 20 mg Dorzolamide.
Pharmaceutical form of applied drug Eye Drops, Solution
Pharmacotherapeutic Group of (API) Dorzolamide: Carbonic anhydrase inhibitors
ATC Code: S01EC03
Reference to Finished product BP specification
specifications
Proposed Pack size 1 x 5 ml
Proposed unit price --
The status in reference regulatory USFDA Trusopt 20 mg/ml Eye drops, solution
authorities Santen pharmaceuticals Co., Ltd Japan
For generic drugs (me-too status) Trusopt Ophthalmic Drops 2% 5ml by OBS
Pharma (Pvt) Karachi
Ltd, Pakistan
Regd. No. 021100
Pack size: 5 ml
Name and address of API manufacturer. Dorzolamide
Dorzolamide from Neuland Laboratories Limited,
Unit-1 Sy. No: 347, 473, 474, 490 / 2
Veerabhadraswamy temple road, Bonthapalli
Village, Gummadidala Mandal, Sangareddy District
- 502 313 Telangana, India
template. Firm has summarized information related
to nomenclature, structure, general properties,

impurities, specifications, analytical procedures and
its validation, batch analysis and justification of
drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance
data related to nomenclature, structure, general
analysis and justification of specification, reference
standard, container closure system and stability
studies of drug substance.
Stability Studies of Drug Substance Dorzolamide
(Conditions duration of Stability studies) Long-term stability studies were performed at a
storage temperature of 30°C±2°C/65%±5% RH for
60 months.
Accelerated stability studies were performed at a
temperature of 40±2°C/75%±5% RH for 6 months.
Module-III Drug Product: Firm has submitted data of drug product including
its description, composition, pharmaceutical
development, manufacture, manufacturing process
and process control, process validation protocols,
control of excipients, control of drug product,
specifications, analytical procedures, validation of
analytical procedures, batch analysis, justification of
specifications, reference standard or materials,
container closure system and stability.
Comparative Dissolution Profile reference product of “Trusopt sterile ophthalmic
Solution” by Santen pharmaceuticals Co., Ltd.
Imported by OBS pharma
Analytical method validation/verification Firm has submitted verification studies of the drug
of product substance and the drug product.
Stability studies Firm has submitted stability studies data of three
batches at both accelerated and long term
conditions.
Dorzolamide
Dorzolamide from Neuland Laboratories Limited, Unit-1 Sy. No:
Manufacturer of APIs 347, 473, 474, 490 / 2 Veerabhadraswamy temple road, Bonthapalli
Village, Gummadidala Mandal, Sangareddy District - 502 313
Telangana, India
DZ10420013 (Dorzolamide)
API Lot No.
Low density polyethylene bottle with insert-cap assembly, HDPE
Description of Pack
screw- cap over a LDPE nozzle with tamper–evident LDPE
(Container closure system)
dustcover sealing the bottle cap.
Stability Storage Condition Real time: 30oC ± 2oC / 35% HR ±5%

Accelerated: 40oC ± 2oC / NMT 25% HR
Real time: 3 months
Time Period
Accelerated: 0, 3 (Months)
Frequency
Real Time: 0, 3 (Months)
Batch No. PDDN0012021 PDDN0022021 PDDN0032021
Batch Size 5 liter 5 liter 5 liter
Manufacturing Date 07/2021 07/2021 07/2021
# Documents To Be Status
Provided
1. Reference of previous N/A
approval of applications
with stability study data
of the firm (if any)
2. Approval of API/ Dorzolamide
DML/GMP certificate Copy of GMP certificate in the name of Neuland Laboratories
of API manufacturer Limited, Unit-1 Sy. No: 347, 473, 474, 490 / 2 Veerabhadraswamy
issued by concerned temple road, Bonthapalli Village, Gummadidala Mandal,
regulatory authority of Sangareddy District - 502 313 Telangana, India, valid upto 28-06-
country of origin. 2022 issued by Drug Control Administration, Government of
Telangana, India.
3. Documents for the Copy of commercial invoice attested by AD I&E DRAP, Lahore,
procurement of API with has been submitted.
approval from DRAP (in Date of
Quantity
case of import). Batch No. approval
Imported
by DRAP
DZ10420013 (Dorzolamide) 1 kg 08-06-2021
The commercial invoice is in the name of M/s Pacific

Pharmaceuticals Ltd., 30th KM, Multan Road, Lahore.
4. Data of stability batches
will be supported by
attested respective Firm has submitted data of stability batches along with batch
documents like manufacturing record and analytical record.
chromatograms, Raw
data sheets, COA,
summary data sheets etc.
5. Compliance Record of
HPLC software 21CFR
Firm has submitted audit trail reports on product testing.
& audit trail reports on
product testing.
6. Record of Digital data
logger for temperature &
Firm has submitted Record of Digital data logger for temperature &
humidity monitoring of
humidity monitoring of stability chambers (real time and
stability chambers
accelerated)
(real time and
accelerated)
Remarks of Evaluator (II):
Section# Observations Firm’s response
1.5.6 Drug product specifications Firm has now claimed European Pharmacopoeia
have been referred to as Specifications
Innovator’s specifications

whereas Pharmacopoeial
monographs are available for
applied product.
Dorzolamide HCl
3.2. • Drug substance • In BP/Ph. Eur there is potentiometric titration for
S.4.1 manufacturer has declared API assay determination while in USP there is use
drug substance as of Ph. of HPLC for Assay determination, which is better
Eur grade for related technique and equipment than the technique adopted
substances whereas the by drug substance manufacturer.
submitted Assay test is • Copies of analytical procedure submitted from drug
declared as per USP product manufacturer.
pharmacopoeia.
• The analytical method for
Assay submitted by drug
product manufacturer is
different form that
proposed by the drug
substance manufacturer.
• Copies of the Drug
substance specifications
and analytical procedures
used for routine testing of
the Drug substance /Active
Pharmaceutical Ingredient
by Drug Product
manufacturer is required.
3.2.P.5.1 • Submitted drug product Microbial report for Preservative testing has been
specifications does not submitted now.
include test of
“Preservative
Effectiveness testing”.
3.2. P.6 COA of primary / secondary Submitted
reference standard including
source and lot number shall be
provided.
3.2. P.8 Following shall be submitted: • Firm has submitted 6 months stability data along
• Stability studies till 3rd woith analytical record.
month time point has been
submitted only.
• Analytical record i.e.,
HPLC chromatograms,
raw data sheets & COAs
shall be submitted for
complete stability studies
till 6th month time point.
2.3.R.1. • As per submitted BMRs • No terminal sterilization has been performed, for
1 terminal sterilization has which firm has submitted that aseptic area
not been performed. manufacturing tank under LAF and aseptic blowing,
Justification shall be filling/sealing multiple function cartage assembling
submitted in this regard. 0.65µm+0.45µm+0.22µm in manufacturing for
• The proposed batch size filtration of solution and 0.22 in filling BFS machine
shall be justified against which already mention
the minimum handling in BMR so our product is sterile by filtration and
aseptic process.
capacity of the formulation
tank.
Decision of 316th meeting: Registration Board deferred the case for further deliberation regarding
use of drug substance by M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder Industrial Estate,
Lahore, for the manufacturing of stability batches, which had been procured and imported by M/s
Pacific Pharmaceuticals Ltd., 30th KM, Multan Road, Lahore.
Firm’s response:
We Pacific Pharmaceuticals Ltd. Ravi Lane Plot No. 384, Sundar Industrial Estate, Raiwind Lahore
(DML 000902) have borrowed drug substance material used in the following products (Dorzil Eye
drops, Glucozole-T Eye Drops, Pacilact-D IV Infusion 500ml, Pacilact-D IV Infusion 1000ml) for
stability and validation purpose only from Pacific Pharmaceuticals Ltd. 30th Km Multan Road,
Lahore (DML 000295).
The justification for the borrowing was based on the fact that commercial department dealing with
procurement was common for both plants operating from the address 30th Km Multan Road, Lahore.
However, we have already started using dedicated procurement for IV plant. We assure that all of
our future procurement will be made by Pacific Pharmaceuticals Ltd. Ravi Lane Plot No. 384, Sundar
Industrial Estate, Raiwind Lahore (DML 000902) separately and dedicatedly.
• Manufacturer will perform process validation of first three batches as per the commitment
submitted in the registration application.
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Plot No. 384,
Sunder Industrial Estate, Lahore
☐ Importer
giver)
facility dated 24-06-2019 which specifies Ophthalmic
(General) Section
☐ Export sale
Dy. No. and date of submission Dy.No 24883 dated 08-09-2021
The proposed proprietary name / brand Glucozole-T 5ml Eye Drops
name

Active Pharmaceutical ingredient (API) Dorzolamide as Dorzolamide HCl ………. 20mg
per unit Timolol as Timolol Maleate ……… 5mg
Pharmaceutical form of applied drug Eye drops, solution
Pharmacotherapeutic Group of (API) Dorzolamide
Carbonic anhydrase inhibitors
ATC Code: S01EC03
Timolol: nonselective beta-adrenergic
receptor blocker
ATC Code: S01ED01
Reference to Finished product Innovator’s Specs
specifications
Proposed Pack size 5ml
The status in reference regulatory Approved by US FDA
authorities
For generic drugs (me-too status) Cosopt sterile ophthalmic Solution Solution by:
Santen pharmaceuticals Co., Ltd. Japan
Regd. No. 025294
Pack size: 5 ml
Name and address of API manufacturer. Dorzolamide HCl: M/sNeuland Laboratories
Limited, Unit-1 Sy. No: 347, 473, 474, 490 / 2
Veerabhadraswamy temple road, Bonthapalli
Village, Gummadidala Mandal, Sangareddy
District – 502 313 Telangana, India
Timolol maleate: FDC Limited, 142-48, Swami
Vivekananda Road Jogeshwari (West) Mumbai-
400 102.
container closure system and stability studies of
drug substance and drug product.
drug substance.
Stability Studies of Drug Substance Dorzolamide HCl: Long-term stability studies
(Conditions duration of Stability studies) were performed at a storage temperature of
30°C±2°C/65%±5% RH for 36months.

Timolol maleate: Long-term stability studies were
performed at a storage temperature of
30°C±2°C/65%±5% RH for 36months.
analytical procedures, batch analysis, justification
of specifications, reference standard or materials,
Comparative Dissolution Profile reference product of “Cosopt” of M/s Santen
Pharmaceuticals.
Analytical method Firm has submitted verification studies of the drug
validation/verification of product substance and the drug product.
batches at both accelerated and long-term
conditions.
Dorzolamide HCl: M/s Neuland Laboratories Limited, Unit-1 Sy.
No: 347, 473, 474, 490 / 2 Veerabhadraswamy temple road,
Manufacturer of APIs Bonthapalli Village, Gummadidala Mandal, Sangareddy District –
502 313 Telangana, India
Timolol maleate: FDC Limited, 142-48, Swami Vivekananda Road
Jogeshwari (West) Mumbai-400 102.
Dorzolamide HCl: DZI0420013
API Lot No.
Timolol maleate: 021D026
Description of Pack Low Density Polyethylene Bottle
(Container closure
system)
Condition Accelerated: 40°C ± 2°C / NMT 25% RH
Real time: 6 months
Time Period
Frequency
Batch No. TD0109O TD0209O TD0309O
Batch Size 10 liters 10 liters 10 liters
# Documents To Be Provided Status
1. Reference of previous approval of N/A
applications with stability study data of
the firm (if any)

2. Approval of API/ DML/GMP certificate Dorzolamide HCl:
of API manufacturer issued by Copy of GMP certificate in the name of M/s
concerned regulatory authority of Neuland Laboratories Limited valid upto 28-06-
country of origin. 2022 issued by DCA Tealngana.
Timolol maleate:
Copy of GMP certificate (certificate#NEW-
WHO-GMP/CERT/KD/72416/2018/11/24412) in
the name of M/s FDC Limited valid upto 08-08-
2021 issued by FDA Maharashtra.
3. Documents for the procurement of API Copy of commercial invoice attested by AD I&E
with approval from DRAP (in case of DRAP, Lahore, has been submitted.
import). Date of
Quantity
Batch No. approval
Imported
by DRAP
011909031 5875 03-10-2019
Firm has submitted that Invoice stated the address

Mis Pacific Pharmaceuticals Ltd. 30th Km Multan
Road, Lahore
4. Data of stability batches will be Firm has submitted data of stability batches along
supported by attested respective with batch manufacturing record and analytical
documents like chromatograms, Raw record.
data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software
21CFR & audit trail reports on product N/A
testing.
Firm has submitted Record of Digital data logger
temperature & humidity monitoring of
for temperature & humidity monitoring of stability
stability chambers
chambers (real time and accelerated)
Remarks of Evaluator (II):
In response to the following shortcomings communicated to firm vide letter no. F.1-1/2020/PEC-
DRAP (AD PEC-II), firm has submitted that due to some errors in our previous data we have
submitted the updated stability batches data along with 6 months stability report. Kindly consider
this updated data and withdraw or neglect our previous data at the date of submission of dossier.
Details of revised stability data are as under:
Dorzolamide HCl: M/s Neuland Laboratories Limited,
Unit-1 Sy. No: 347, 473, 474, 490 / 2 Veerabhadraswamy
Manufacturer of APIs temple road, Bonthapalli Village, Gummadidala Mandal,
Sangareddy District – 502 313 Telangana, India
Timolol maleate: FDC Limited, 142-48, Swami
Vivekananda Road Jogeshwari (West) Mumbai-400 102.
Dorzolamide HCl: DZI0420013
API Lot No.
Timolol maleate: 021D026
Description of Pack Low Density Polyethylene Bottle
Real time: 30°C ± 2°C / 35% ± 5%RH
Stability Storage Condition
Accelerated: 40°C ± 2°C / NMT 25% RH
Real time: 6 months
Time Period
Frequency
Batch No. PDEN0012021 PDEN0022021 PDEN0032021
Batch Size 5 liters 5 liters 5 liters
Manufacturing Date 12-07-2021 12-07-2021 12-07-2021
# Documents to be provided Status
1. Reference of previous approval N/A
of applications with stability
study data of the firm (if any)
2. Approval of API/ DML/GMP Dorzolamide HCl:
certificate of API manufacturer Copy of GMP certificate in the name of M/s Neuland
issued by concerned regulatory Laboratories Limited valid upto 28-06-2022 issued by DCA
authority of country of origin. Telangana.
Timolol maleate:
Copy of GMP certificate (Certificate#NEW-WHO-
GMP/CERT/KD/72416/2018/11/24412) in the name of
M/s FDC Limited valid upto 08-08-2021 issued by FDA
Maharashtra.
3. Documents for the Copy of commercial invoice attested by AD I&E DRAP,
procurement of API with Lahore, has been submitted.
approval from DRAP (in case Quantity
Batch Date of approval
of import). API Importe
No. by DRAP
d
Dorzolamide DZT0420 1Kg 08-06-2021
013
Timolol 1386/186 0.025gm 08-06-2021
Submitted invoices are in the name of M/s Pacific

Pharmaceuticals Ltd. 30th Km Multan Road, Lahore.
4. Data of stability batches will be Firm has submitted data of stability batches along with
supported by attested batch manufacturing record and analytical record.
respective documents like
chromatograms, Raw data
sheets, COA, summary data
sheets etc.
software 21CFR & audit trail N/A
6. Record of Digital data logger
for temperature & humidity Firm has submitted Record of Digital data logger for
monitoring of stability temperature & humidity monitoring of stability chambers

1.5.6 Drug product specifications have been It was a typographic error. Product is
referred to as Innovator’s according to the European pharmacopoeial
specifications whereas Pharmacopoeial monographs.
monographs are available for applied
product.
Dorzolamide HCl
3.2. S.4.1 • Drug substance manufacturer has • In BP/Ph. Eur there is potentiometric
declared drug substance as of Ph. Eur titration for API assay determination while
grade, whereas the submitted Assay in USP there is use of HPLC for Assay
method is as per USP pharmacopoeia. determination, which is better technique

• Copies of the Drug substance and equipment than the technique adopted
specifications and analytical by drug substance manufacturer.
procedures used for routine testing of • Copies of analytical procedure submitted
the Drug substance /Active from drug product manufacturer.
Pharmaceutical Ingredient by Drug
Product manufacturer is required.
3.2.S.4.3 Analytical Method Verification studies Submitted.
including specificity, accuracy and
3.2.S.4.4 Provide results of analysis of relevant Submitted.
batch(es) of Drug Substance performed
by Drug Product manufacturer used
during product development and
stability studies, along with Certificate
of Analysis (CoA) of the same batch
from Drug Substance / /Active
manufacture.
3.2. S.7 Drug substance stability data as per Submitted as per Zone-IVa.
Zone IV a condition shall be submitted.
Timolol maleate
3.2. S.4.1 Copies of the Drug substance Submitted
specifications and analytical
procedures used for routine testing of
3.2. S.4.3 Analytical Method Verification studies Submitted
including specificity, accuracy and
3.2. S.4.4 Provide results of analysis of relevant Submitted.
during product development and
stability studies, along with Certificate
of Analysis (CoA) of the same batch
from Drug Substance / /Active
manufacture.
3.2. S.7 Submitted stability reports are not Submitted
readable.
3.2. P.3.5 Process validation protocol shall be Submitted
submitted.
3.2. P.5.3 Analytical method verification studies Analytical method verification studies have
performed by drug product been submitted for Dorzolamide only.
3.2. P.6 COA of primary / secondary reference Submitted
standard including source and lot
number shall be provided.
3.2. P.8 Following shall be submitted:

• Complete batch manufacturing • BMR for three trial batches have been
record of stability trial batches. submitted
• Documents for the procurement of • No terminal sterilization has been
API with approval from DRAP (in performed, for which firm has submitted
case of import). that aseptic area manufacturing tank under
• Record of Digital data logger for LAF and aseptic blowing, filling/sealing
temperature & humidity monitoring multiple function cartage assembling
of stability chambers 0.65µm+0.45µm+0.22µm in
• Submitted analytical record reflect manufacturing for filtration of solution and
that chromatographic conditions for 0.22 in filling BFS machine which already
the Assay analysis of Dorzolamide mention in BMR so our product is sterile
have not been performed as per by filtration and aseptic process.
recommendations of USP • Firm has applied “Solution preparation
monograph, since the gradient run tank” of 100 litres for the manufacturing of
time as per monograph is of 30 5 litre batch size stating that design
minutes while the firm has run capacity of active manufacturing tank
HPLC chromatogram, for about 12 ranges from 5 litres to 100 litres so, 5 litres
minutes only. batch can be easily processed.
• Submitted HPLC chromatograms reflect
that the chromatographic conditions for the
Assay test have not been complied as per
USP monograph in terms of the run time
for which firm has replied that although the
injection run time is 30minute but the
peaks separation of Dorzolamide is about
12 minutes. In the chromatograms sample
run time is about 20minute but there is no
any further peak found. So, it Is not big
issue, in future will follow up to 30minutes.
Firm has submitted fee of Rs. 30,000/- for revision of stability data as per following details:
Rs. 7,500/- vide deposit slip#5349893974 dated 01-03-2022
Rs. 22500/- vide deposit slip#92601467 dated 09-03-2022
Firm’s response:
We Pacific Pharmaceuticals Ltd. Ravi Lane Plot No. 384, Sundar Industrial Estate, Raiwind
Lahore (DML 000902) have borrowed drug substance material used in the following products
(Dorzil Eye drops, Glucozole-T Eye Drops, Pacilact-D IV Infusion 500ml, Pacilact-D IV Infusion
1000ml) for stability and validation purpose only from Pacific Pharmaceuticals Ltd. 30th Km
Multan Road, Lahore (DML 000295).
procurement was common for both plants operating from the address 30th Km Multan Road,
Lahore.
our future procurement will be made by Pacific Pharmaceuticals Ltd. Ravi Lane Plot No. 384,
Sundar Industrial Estate, Raiwind Lahore (DML 000902) separately and dedicatedly.
Decision of 320th meeting: Approved with USP specifications.

5. Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot
Marketing Authorization Holder No., 384, Sundar industrial Estate, Raiwind
Road, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot
No., 384, Sunder Industrial Estate, Raiwind Road,
Lahore
☐ Importer
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
The proposed proprietary name / brand Pacilact-D IV Infusion 500ml
name
Strength / concentration of drug of Each 100ml Contains:
Active Pharmaceutical ingredient (API) Sodium Chloride….…0.60g
per unit Potassium Chloride…….0.03g
Calcium Chloride Dihydrate…….0.02g
Sodium Lactate …… 0.31gram
Dextrose Monohydrate Eq. to Anhydrous
Dextrose…….4.3g
Pharmaceutical form of applied drug Intravenous Infusion
Pharmacotherapeutic Group of (API) Electrolyte
Reference to Finished product USP
specifications
authorities
For generic drugs (me-too status) Lactated Ringer’s and 5% Dextrose Injection of M/s
Medipak Limited (Reg.no: 008242)
GMP status of the Finished product New DML issued on 24-06-2019
manufacturer
Name and address of API manufacturer. Sodium Chloride: Dominion Salt Limited, 89
Totara Street, Mount Maunganui, New Zealand.
Calcium Chloride Dihydrate: Hebei Huachen
Pharmaceuticals. Ltd.
Potassium Chloride: Hebei Huachen
Pharmaceuticals Ltd., Economic Devleopment
zone. Hebei, China Sodium Lactate: Corbion
Purac Bioquimica SA, BarcelonaSpain

Dextrose: M/s CSPC Shengxue Glucose Co., Ltd,
No.48 Shengxue Road, Luancheng District, China-
051430 Shijiazhuang City, Hebei Province.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS
PD template.
Module-III (Drug Product): Firm has submitted relevant information against the
Module III, including, Process validation protocol,
Finished product analytical method verification
report & stability studies data.
Remarks: Firm has submitted Pharmaceutical equivalence studies against the reference
product of 5% DEXTROSE in LACTATED RINGER’S INJECTION of M/s B Braun.
Manufacturer of API Sodium Chloride: Dominion Salt Limited, 89 Totara Street, Mount
Maunganui, New Zealand.
Calcium Chloride Dihydrate: Hebei Huachen Pharmaceuticals. Ltd.
Potassium Chloride: Hebei Huachen Pharmaceuticals Ltd.,
Economic Devleopment zone. Hebei, China
Sodium Lactate: Corbion Purac, Spain
Dextrose: M/s CSPC Shengxue Glucose Co., Ltd, No.48 Shengxue
Road, Luancheng District, China-051430 Shijiazhuang City, Hebei
Province.
API Lot No. Sodium Chloride: 0801209
Calcium Chloride Dihydrate: 20190826
Potassium Chloride: 190815
Sodium Lactate: 1904001735
Dextrose: 201906001
Description of Pack
Low Density Polyethylene film bags.
Time Period Real time: 6 months
Frequency Accelerated: 0, 3, 6 (Months)
Batch No. RN0111O RN0211O RN0311O
Batch Size 4000 litres 4000 litres 4000 litres
Manufacturing Date 15/10/2019 16/10/2019 17/10/2019
No. of Batches 03
Details of Documents submitted
1. Reference of previous approval of --
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate
of API manufacturer issued by concerned (Certificate# HE20190013) in the name of M/s
regulatory authority of country of origin. CSPC SHENGXUE Glucose Co., Ltd., No. 48
Shengxue Road, Luancheng District,
Shijiazhuang City, Hebei province, China valid
upto 02-02-2024 issued by HEBEI Dug
Administration.

Sodium Chloride: Firm has submitted copy of
GMP
certificate in the name of M/s Dominion Salt
Ltd., 89, totara street, Mount Maunganui,
NewZeland valid upto 29-03-2021 issued by
Ministry of Health, Newzeland.
Calcium Chloride Dihydrate: Firm has
submitted GMP certificate (Certificate#
HE20180030) issued by Hebei food & Drug
administration valid till 22-04-2023.
Potassium Chloride: Firm has submitted GMP
certificate (Certificate# HE20180030) issued by
Hebei food & Drug administration valid till 22-
04-2023.
Sodium Lactate: Firm has submitted Eudra
GMP certificate (Certificate# NCF-
II/1817/001/CAT) is valid till April 2021.
Dextrose anhydrous: Firm has submitted copy
of GMP certificate (Certificate# HE20190013)
in the name of M/s CSPC SHENGXUE Glucose
Co., Ltd., No. 48 Shengxue Road, Luancheng
District, Shijiazhuang City, Hebei province,
China valid upto 02-02-2024 issued by HEBEI
Dug Admiistration.
3. Documents for the procurement of API Sodium Lactate: Firm has submitted copy of
with approval from DRAP (in case of invoice attested by AD DRAP I&E Lahore, M/s
import). Pacific Pharmaceuticals Ltd., 30 Km, Multan
Road, Lahore dated 21-10-2019 specifying the
quantity of 800Kgs of Sodium lactate (60%).
submitted copy of invoice attested by AD DRAP
I&E Lahore dated 21-10-2019, M/s Pacific
Pharmaceuticals Ltd., Ravi lane, Plot No.,
384, Sundar industrial Estate, Raiwind Road,
Lahore specifying the quantity of 1MTS.
Potassium Chloride: Firm has submitted copy
of invoice attested by AD DRAP I&E Lahore
dated 21-10-2019, M/s Pacific
384, Sundar industrial Estate, Raiwind Road,
Lahore specifying the quantity of 1MTS.
of commercial invoice (Invoice#. 20ST27003)
attested by AD DRAP I&E Lahore, dated 03-10-
2019, in the name of M/s Pacific
Pharmaceuticals Ltd., 30 Km, Multan Road,
Lahore specifying the quantity of 5000Kgs of
Dextrose anhydrous (Batch# 201906001) from
M/s CSPC SHENGXUE Glucose Co., Ltd., No.
48 Shengxue Road, Luancheng District,
Shijiazhuang City, Hebei province, China.
4. Data of stability batches will be supported Submitted
by attested respective documents like
chromatograms, Raw data sheets, COA,

5. Compliance Record of HPLC software Not applicable
21CFR & audit trail reports on product
testing
temperature and humidity monitoring of
stability chambers (real time and
accelerated)
Remarks of EvaluatorII:
Sr. Section Deficiencies Firm’s response
No. #.
Calcium Chloride
1. 3.2. • Address of drug substance • It was a typographic error, the said
S.2.1 manufacturer mentioned in this section has been revised.
section is different from that
mentioned on the COA from drug
2. 3.2.S.4. • The drug substance COA from drug • It was a typographic error, we have
4 substance manufacturer declare it rectified the error. Our COA is also as
of BP grade, whereas COA from BP grade.
drug product manufacturer declare
it as of USP grade.
Sodium Lactate
3. 3.2.S.4 • The Assay limits in the COA of According to USP monograph, Sodium
drug substance manufacturer is Lactate Solution is an aqueous solution
59% -61%, whereas the Assay containing not less than 50.0 percent, by
limits in the COA of drug product weight, of monosodium lactate. It
manufacturer is 95.0% - 110.0%. contains not less than 98.0 percent and
• The Assay results in the COA of not more than 102.0 percent of labeled
drug substance manufacturer is amount of C3H5NaO3.We have
60.1%, whereas the Assay limits overlooked the COA of drug substance.
in the COA of drug product This was typographical error from
manufacturer is 101.28%. supplier we have intimated the supplier
and will provide you correct COA later.
However, Assay limits in the COA of
drug product manufacturer is 101.28%
according to specifications.
4. 1.5.2 & • The reference product contains • According to Martindale Anhydrous
3.2. P.1 Dextrose monohydrate = glucose 900 mg is equivalent to about
5gm/100ml, while firm has 1 g of glucose monohydrate. 50g/litre
applied for Dextrose anhydrous = of glucose monohydrate is (equivalent
4.3gm/100ml. to about 45 g/litre of anhydrous
• You are advised to justify the glucose).
variation in formulation from
reference product or else submit
revised composition as per
reference product along with
relevant fee as per Notification
No. F.7-11f2012-B&A/DRAP
dated 07th May, 2021.
5. 3.2. • Evidence of availability of atomic Firm has submitted calibration
P.5.2 absorption spectrophotometer and certificate for atomic absorption
flame photometry, as required by spectrophotometer.

the USP monograph of applied List of equipment including Flame
product, shall be submitted photometer has been submitted.
6. 3.2. • You are advised to submit • We have followed Sterilization
P.3.3 justification for applying process by super-heated water
sterilization conditions other than showering at 109ºC for 85 minutes.
the standard conditions for • 121ºC & Time ≥ 15 min, this
terminal sterilization by moist temperature is used for machine
heat i.e., temperature 121oC & sterilization before running product
Time > 15 min.
7. • The date of manufacturing of three stability •
We have purchased the material from
batches i.e., RN0111O, RN0211O, Medipak Limited for sample. Attested
RN0311O, as per submitted BMR is invoice by AD DRAP I&E Lahore
15/10/2019,16/10/2019 & 17/10/2019 dated 21-10-2019 was after
respectively, whereas commercial invoice manufacturing of RN0111O,
submitted for Potassium chloride & Calcium RN0211O, RN0311O batches. This
chloride is attested by AD DRAP I&E material was imported for commercial
Lahore dated 21-10-2019. manufacturing of other products
• Justify the quantities of Dextrose anhydrous which is not used in these batches.
dispensed for batch manufacturing The Correct invoice is attached.
considering the proposed label claim OF • The quantity of dextrose anhydrous
Dextrose anhydrous 4.3gm/100ml. dispensed for batch manufacturing
• Justify the dispensed quantity of Sodium considering the proposed label claim
Lactate dispensed for batch manufacturing of Dextrose anhydrous is 4.5g/100ml.
considering the Assay percentage of drug (As per submitted BMR Dextrose
substance declared in the submitted COA anhydrous has been dispensed as per
from Pacific Pharma. 5gm/100ml which is not as per
• Submit analytical record for the analysis of reference product.)
Potassium, Sodium & Calcium for the • We have used sodium lactate (as
stability studies. sodium lactate solution (60% w/v) as
• Submit reconciliation record for the label claim.
imported quantity of 1 MTS each of (Dispensed quantity is not as per the
Potassium chloride & Sodium chloride. percentage purity of sodium lactate
determined by the Pacific pharma)
• We have purchased the material from
Medipak Limited for sample. Attested
invoice by AD DRAP I&E Lahore
dated 21-10-2019 was after
manufacturing of RN0111O,
RN0211O, RN0311O batches. This
material was imported for commercial
manufacturing of other products
which is not used in these batches.
th
Decision of 307 meeting: Registration Board deferred the case for submission of following:
• Revised label claim for Dextrose monohydrate as per the innovator’s product, along with
submission of relevant fee.
• Legal provision of utilizing Drug substances purchased from another DML holder i.e., M/s
Medipak Limited.
Firm’s response: Firm has submitted new stability studies data on 28-10-2021, along with
correction in label claim of Dextrose monohydrate. Fee for the submission of new stability data has
not been submitted. Details of new stability data are as under:
Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot
Marketing Authorization Holder No., 384, Sundar industrial Estate, Raiwind Road,
Lahore

Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot No.,
384 Sundar industrial Estate, Raiwind Road, Lahore
☐ Importer
facility dated 24-06-2019 which specifies Large volume
parental section.
☐ Export sale
Dy. No. and date of submission Dy. No. 29420 dated 28-10-2021
Details of fee submitted Rs. 30,000/- vide deposit slip# 516358736
name
Active Pharmaceutical ingredient (API) Sodium Chloride….…0.60g
per unit Potassium Chloride…….0.03g
Dextrose…….5g
specifications
authorities
Medipak Limited (Reg.no: 008242)
Name and address of API manufacturer. Sodium Chloride: Dominion Salt Limited, 89 Totara
Street, Mount Maunganui, New Zealand.
Potassium Chloride: Hebei Huachen Pharmaceuticals
Ltd., Economic Devleopment zone. Hebei, China
Sodium Lactate: Corbion Purac Bioquimica SA,
BarcelonaSpain
No.48 Shengxue Road, Luancheng District, China-
051430 Shijiazhuang City, Hebei Province.

template. Firm has summarized information related to
nomenclature, structure, general properties, solubilities,
specifications, analytical procedures and its validation,
batch analysis and justification of specification,
reference standard, container closure system and
stability studies of drug substance and drug product.
properties, solubilities, physical form, manufacturers,
impurities, specifications, analytical procedures and its
system and stability studies of drug substance.
Stability Studies of Drug Substance Real time: 30°C ± 2°C / 35% ± 5%RH
(Conditions duration of Stability studies) Accelerated: 40°C ± 2°C / NMT 25% RH
Module-III Drug Product: Firm has submitted data of drug product including its
description, composition, pharmaceutical development,
manufacture, manufacturing process and process
control, process validation protocols, control of
excipients, control of drug product, specifications,
analytical procedures, validation of analytical
procedures, batch analysis, justification of
Pharmaceutical Equivalence and Firm has submitted Pharmaceutical equivalence studies
Comparative Dissolution Profile against the reference product of 5% DEXTROSE in
LACTATED RINGER’S INJECTION of M/s B Braun.
batches at both accelerated and long term conditions.
STABILITY STUDY DATA (Currently Submitted)
Sodium Chloride: Dominion Salt Limited, 89 Totara
Manufacturer of APIs Potassium Chloride: Hebei Huachen Pharmaceuticals
Ltd., Economic Devleopment zone. Hebei, China Sodium Lactate:
Corbion Purac Bioquimica SA, BarcelonaSpain
Province.
Sodium chloride: 08012019
Potassium chloride: 200413
API Lot No. Sodium lactate: 1909000241
Calcium chloride: 20200625
Dextrose: 201906001
Description of Pack Low Density Polyethylene film bags.

Real time: 6 months
Time Period
Frequency
Batch No. LANB001202
LANB0022020 LANB0032020
0
Provided
1. Reference of PACILACT-RL 500 ml IV INFUSION approve in 297 DRB
previous approval of
applications with
stability study data
2. Approval of API/ Sodium Chloride: Firm has submitted copy of GMP certificate in
DML/GMP the name of M/s Dominion Salt Ltd., 89, totara street, Mount
certificate of API Maunganui, NewZeland valid upto 29-03-2021 issued by Ministry
manufacturer issued of Health, Newzeland.
by concerned Calcium Chloride Dihydrate: Firm has submitted GMP certificate
regulatory authority (Certificate# HE20180030) issued by Hebei food & Drug
of country of origin. administration valid till 22-04-2023.
Potassium Chloride: Firm has submitted GMP certificate
(Certificate# HE20180030) issued by Hebei food & Drug
Sodium Lactate: Firm has submitted Eudra GMP certificate
(Certificate# NCF-II/1817/001/CAT) is valid till April 2021.
Dextrose anhydrous: Firm has submitted copy of GMP certificate
(Certificate# HE20190013) in the name of M/s CSPC SHENGXUE
Glucose Co., Ltd., No. 48 Shengxue Road, Luancheng District,
Shijiazhuang City, Hebei province, China valid upto 02-02-2024
issued by HEBEI Dug Admiistration.
3. Documents for the Sodium Lactate: Firm has submitted copy of invoice attested by AD
procurement of API DRAP I&E Lahore, M/s Pacific Pharmaceuticals Ltd., 30 Km,
with approval from Multan Road, Lahore dated 07-07-2020 specifying the quantity of
DRAP (in case of 800Kgs of Sodium lactate (60%).
import). Calcium Chloride Dihydrate: Firm has submitted copy of invoice
attested by AD DRAP I&E Lahore dated 09-09-2020, M/s Pacific
Pharmaceuticals Ltd., Ravi lane, Plot No., 384, Sundar
industrial Estate, Raiwind Road, Lahore specifying the quantity
of 1 MTS.
Potassium Chloride: Firm has submitted copy of invoice attested
by AD DRAP I&E Lahore dated 09-09-2020, M/s Pacific
Pharmaceuticals Ltd., Ravi lane, Plot No., 384, Sundar industrial
Estate, Raiwind Road, Lahore specifying the quantity of 1 MTS.
Dextrose anhydrous: Firm has submitted copy of commercial
invoice (Invoice#. 20ST27003) attested by AD DRAP I&E Lahore,
dated 03-10- 2019, in the name of M/s Pacific Pharmaceuticals
Ltd., 30 Km, Multan Road, Lahore specifying the quantity of
5000Kgs of Dextrose anhydrous (Batch# 201906001) from M/s
CSPC SHENGXUE Glucose Co., Ltd., No. 48 Shengxue Road,
Luancheng District, Shijiazhuang City, Hebei province, China.

4. Data of stability
batches will be
supported by
attested respective Firm has submitted data of stability batches along with batch
chromatograms,
Raw data sheets,
COA, summary data
sheets etc.
5. Compliance Record
of HPLC software
21CFR & audit trail Not applicable
reports on product
testing.
6. Record of Digital
data logger for
temperature & Firm has submitted Record of Digital data logger for temperature &
humidity monitoring humidity monitoring of stability chambers (real time and
of stability chambers accelerated)
(real time and
accelerated)
Firm’s response:
We Pacific pharmaceuticals Ltd. Ravi Lane Plot No. 384, Sundar Industrial Estate, Raiwind Lahore
Lahore.
our future procurement will be made by Pacific pharmaceuticals Ltd. Ravi Lane Plot No. 384,
Decision of 320th meeting: Approved. Registration Board further decided that registration
letter will be issued after submission of full fee that is Rs. 30,000/- as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
6. Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd. Ravi lane,
Marketing Authorization Holder Plot No., 384, Sundar industrial Estate,
Raiwind Road, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot
No., 384, Sunder Industrial Estate, Raiwind Road,

Lahore
☐ Importer
☐ Export sale
name
Strength / concentration of drug of Active Each 100ml Contains:
Pharmaceutical ingredient (API) per unit Sodium Chloride….…0.60g
Potassium Chloride…….0.03g
Dextrose…….4.3g
specifications
authorities
For generic drugs (me-too status) Lactated Ringer’s and 5% Dextrose Injection of
M/s Medipak Limited
GMP status of the Finished product New DML issued on 24-06-2019
manufacturer
Name and address of API manufacturer. Sodium Chloride: Dominion Salt Limited, 89
Totara Street, Mount Maunganui, New Zealand.
Potassium Chloride: Hebei Huachen
Pharmaceuticals Ltd., Economic Devleopment
zone. Hebei, China Sodium Lactate: Corbion
Purac Bioquimica SA, BarcelonaSpain
No.48 Shengxue Road, Luancheng District,
China-051430 Shijiazhuang City, Hebei
Province.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO QOS
PD template.
Module-III (Drug Product): Firm has submitted relevant information against

the Module III, including, Process validation
protocol, Finished product analytical method
verification report & stability studies data.
Remarks: Firm has submitted Pharmaceutical equivalence studies against the reference
product of 5% DEXTROSE in LACTATED RINGER’S INJECTION of M/s B Braun.
Manufacturer of API Sodium Chloride: Dominion Salt Limited, 89 Totara Street, Mount
Maunganui, New Zealand.
Calcium Chloride Dihydrate: Hebei Huachen Pharmaceuticals. Ltd.
Potassium Chloride: Hebei Huachen Pharmaceuticals Ltd., Economic
Devleopment zone. Hebei, China
Sodium Lactate: Corbion Purac, Spain
Province.
API Lot No. Sodium Chloride: 0801209
Calcium Chloride Dihydrate: 20190826
Potassium Chloride: 190815
Sodium Lactate: 1904001735
Dextrose: 201906001
Description of Pack
(Container closure Low Density Polyethylene film bags.
system)
Batch No. RD0111O RD0211O RD0311O
Batch Size 4000 litres 4000 litres 4000 litres
Manufacturing Date 15/10/2019 14/10/2019 14/10/2019
No. of Batches 03
Details of Documents submitted
1. Reference of previous approval of --
the firm (if any)
of API manufacturer issued by concerned (Certificate# HE20190013) in the name of M/s
regulatory authority of country of origin. CSPC SHENGXUE Glucose Co., Ltd., No. 48
Shengxue Road, Luancheng District,
Shijiazhuang City, Hebei province, China valid
upto 02-02-2024 issued by HEBEI Dug
Administration.
Sodium Chloride: Firm has submitted copy of
GMP
certificate in the name of M/s Dominion Salt
Ltd., 89, totara
street, Mount Maunganui, NewZeland valid
upto 29-03-2021

issued by Ministry of Health, Newzeland.
submitted GMP
certificate (Certificate# HE20180030) issued
by Hebei food &
Drug administration valid till 22-04-2023.
Potassium Chloride: Firm has submitted GMP
certificate
(Certificate# HE20180030) issued by Hebei
food & Drug
Sodium Lactate: Firm has submitted Eudra
GMP certificate
(Certificate# NCF-II/1817/001/CAT) is valid
till April 2021.
of GMP certificate (Certificate# HE20190013)
in the name of M/s CSPC SHENGXUE Glucose
Co., Ltd., No. 48 Shengxue Road, Luancheng
District, Shijiazhuang City, Hebei province,
China valid upto 02-02-2024 issued by HEBEI
Dug Admiistration.
3. Documents for the procurement of API Sodium Lactate: Firm has submitted copy of
with approval from DRAP (in case of invoice attested by AD DRAP I&E Lahore, M/s
import). Pacific Pharmaceuticals Ltd., 30 Km, Multan
Road, Lahore dated 21-10-2019 specifying the
quantity of 800Kgs of Sodium lactate (60%).
submitted copy of invoice attested by AD
DRAP I&E Lahore dated 21-10-2019, M/s
Pacific Pharmaceuticals Ltd., Ravi lane, Plot
No., 384, Sundar industrial Estate, Raiwind
Road, Lahore specifying the quantity of
1MTS.
Potassium Chloride: Firm has submitted copy
of invoice attested by AD DRAP I&E Lahore
dated 21-10-2019, M/s Pacific
384, Sundar industrial Estate, Raiwind
Road, Lahore specifying the quantity of
1MTS.
of commercial invoice (Invoice#. 20ST27003)
attested by AD DRAP I&E Lahore, dated 03-
10-2019, in the name of M/s Pacific
Pharmaceuticals Ltd., 30 Km, Multan Road,
Lahore specifying the quantity of 5000Kgs of
Dextrose anhydrous (Batch# 201906001) from
M/s CSPC SHENGXUE Glucose Co., Ltd., No.
48 Shengxue Road, Luancheng District,
Shijiazhuang City, Hebei province, China.
chromatograms,

Raw data sheets, COA, summary data
sheets etc.

testing
stability chambers (real
time and accelerated)
Sr. Section Deficiencies Firm’s response

No. #.
Calcium Chloride
1. 3.2. • Address of drug substance • It was a typographic error, the said
S.2.1 manufacturer mentioned in this section has been revised.
section is different from that
mentioned on the COA from drug
2. 3.2.S.4 • The drug substance COA from drug • It was a typographic error, we have
.4 substance manufacturer declare it of rectified the error. Our COA is also
BP grade, whereas COA from drug as BP grade.
product manufacturer declare it as of
USP grade.
Sodium Lactate
3. 3.2.S.4 • The Assay limits in the COA of drug According to USP monograph, Sodium
substance manufacturer is 59% - Lactate Solution is an aqueous solution
61%, whereas the Assay limits in the containing not less than 50.0 percent, by
COA of drug product manufacturer weight, of monosodium lactate. It
is 95.0% - 110.0%.gmail contains not less than 98.0 percent and
• The Assay results in the COA of not more than 102.0 percent of labeled
drug substance manufacturer is amount of C3H5NaO3.We have
60.1%, whereas the Assay limits in overlooked the COA of drug substance.
the COA of drug product This was typographical error from
manufacturer is 101.28%. supplier we have intimated the supplier
and will provide you correct COA later.
However, Assay limits in the COA of
drug product manufacturer is 101.28%
according to specifications.
4. 1.5.2 & • The reference product contains • According to Martindale Anhydrous
3.2. P.1 Dextrose monohydrate = glucose 900 mg is equivalent to about
5gm/100ml, while firm has applied 1 g of glucose monohydrate. 50g/litre
for Dextrose anhydrous = of glucose monohydrate is (equivalent
4.3gm/100ml. to about 45 g/litre of anhydrous
• You are advised to justify the glucose).
variation in formulation from
reference product or else submit
revised composition as per reference
product along with relevant fee as
per Notification No. F.7-11f2012-
B&A/DRAP dated 07th May, 2021.

5. 3.2. • Evidence of availability of atomic Firm has submitted calibration
P.5.2 absorption spectrophotometer and certificate for atomic absorption
flame photometry, as required by the spectrophotometer.
USP monograph of applied product, List of equipment including Flame
shall be submitted photometer has been submitted.
6. 3.2. • You are advised to submit • We have followed Sterilization process
P.3.3 justification for applying by super-heated water showering at
sterilization conditions other than 109ºC for 85 minutes.
the standard conditions for terminal • 121ºC & Time ≥ 15 min, this
sterilization by moist heat i.e., temperature is used for machine
temperature 121oC & Time > 15 sterilization before running product
min.
7. • The date of manufacturing of three stability • We have purchased the material from
batches i.e., RN0111O, RN0211O, Medipak Limited for sample. Attested
RN0311O, as per submitted BMR is invoice by AD DRAP I&E Lahore
15/10/2019,16/10/2019 & 17/10/2019 dated 21-10-2019 was after
respectively, whereas commercial invoice manufacturing of RN0111O,
submitted for Potassium chloride & Calcium RN0211O, RN0311O batches. This
chloride is attested by AD DRAP I&E Lahore material was imported for commercial
dated 21-10-2019. manufacturing of other products
• Justify the quantities of Dextrose anhydrous which is not used in these batches. The
dispensed for batch manufacturing Correct invoice is attached.
considering the proposed label claim OF • The quantity of dextrose anhydrous
Dextrose anhydrous 4.3gm/100ml. dispensed for batch manufacturing
• Justify the dispensed quantity of Sodium considering the proposed label claim
Lactate dispensed for batch manufacturing of Dextrose anhydrous is 4.5g/100ml.
considering the Assay percentage of drug (As per submitted BMR Dextrose
substance declared in the submitted COA anhydrous has been dispensed as per
from Pacific Pharma. 5gm/100ml which is not as per
• Submit analytical record for the analysis of reference product.)
Potassium, Sodium & Calcium for the • We have used sodium lactate (as
stability studies. sodium lactate solution (60% w/v) as
• Submit reconciliation record for the imported label claim.
quantity of 1 MTS each of Potassium chloride (Dispensed quantity is not as per the
& Sodium chloride. percentage purity of sodium lactate
determined by the Pacific pharma)
• We have purchased the material from
Medipak Limited for sample. Attested
invoice by AD DRAP I&E Lahore
dated 21-10-2019 was after
manufacturing of RN0111O,
RN0211O, RN0311O batches. This
material was imported for commercial
manufacturing of other products
which is not used in these batches.
Decision of 307th meeting: Registration Board deferred the case for submission of following:
• Revised label claim for Dextrose monohydrate as per the innovator’s product, along with
submission of relevant fee.
• Legal provision of utilizing Drug substances purchased from another DML holder i.e., M/s
Medipak Limited.
Firm’s response: Firm has submitted new stability studies data on 28-10-2021, along with
correction in label claim of Dextrose monohydrate. Fee for the submission of new stability data has
not been submitted. Details of new stability data are as under:

Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot No.,
Marketing Authorization Holder 384,Sundar industrial Estate, Raiwind Road, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Ravi lane, Plot No.,
384,Sundar industrial Estate, Raiwind Road, Lahore
☐ Importer
Evidence of approval of Firm has submitted copy of section approval letter dated
manufacturing facility 24-06-2019 which specifies Large volume parental
section.
Details of fee submitted Rs. 30,000 vide deposit slip# 3015188420
The proposed proprietary name / Pacilact-D IV Infusion 1000ml
brand name
Active Pharmaceutical ingredient Sodium Chloride….…0.60g
(API) per unit Potassium Chloride…….0.03g
Dextrose…….5g
specifications
authorities
Medipak Limited
Name and address of API Sodium Chloride: Dominion Salt Limited, 89 Totara
manufacturer. Street, Mount Maunganui, New Zealand.
Potassium Chloride: Hebei Huachen Pharmaceuticals
Ltd., Economic Devleopment zone. Hebei, China
Sodium Lactate: Corbion Purac Bioquimica SA,
BarcelonaSpain

Dextrose: M/s CSPC Shengxue Glucose Co., Ltd, No.48
Shengxue Road, Luancheng District, China-051430
Shijiazhuang City, Hebei Province.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Firm has summarized information related to
batch analysis and justification of specification, reference
standard, container closure system and stability studies of
Module-III Drug Substance: Firm has submitted detailed data for drug substance data
related to nomenclature, structure, general properties,
solubilities, physical form, manufacturers, description of
drug substance.
Stability Studies of Drug Substance Real time: 30°C ± 2°C / 35% ± 5%RH
(Conditions duration of Stability Accelerated: 40°C ± 2°C / NMT 25% RH
studies)
manufacture, manufacturing process and process control,
process validation protocols, control of excipients, control
of drug product, specifications, analytical procedures,
validation of analytical procedures, batch analysis,
justification of specifications, reference standard or
materials, container closure system and stability.
Pharmaceutical Equivalence and Firm has submitted Pharmaceutical equivalence studies
Comparative Dissolution Profile against the reference product of 5% DEXTROSE in
LACTATED RINGER’S INJECTION of M/s B Braun.
Stability studies Firm has submitted stability studies data of three batches
at both accelerated and long term conditions.
STABILITY STUDY DATA (Currently Submitted)
Sodium Chloride: Dominion Salt Limited, 89 Totara
Manufacturer of APIs Potassium Chloride: Hebei Huachen Pharmaceuticals
Ltd., Economic Devleopment zone. Hebei, China Sodium
Lactate: Corbion Purac Bioquimica SA, BarcelonaSpain
Province.
Sodium chloride: 08012019
API Lot No. Potassium chloride: 200413
Sodium lactate: 1909000241

Calcium chloride: 20200625
Dextrose: 201906001
Description of Pack Low Density Polyethylene film bags.
Real time: 30°C ± 2°C / 35% ± 5%RH
Accelerated: 40°C ± 2°C / NMT 25% RH
Real time: 6 months
Time Period
Frequency
Batch No. LANA00120
LANA0022020 LANA0032020
20
Provided
1. Reference of PACILACT-RL 1000 ml IV INFUSION approve in 297 DRB
previous approval of
applications with
stability study data
2. Approval of API/ Sodium Chloride: Firm has submitted copy of GMP certificate in
DML/GMP the name of M/s Dominion Salt Ltd., 89, totara street, Mount
certificate of API Maunganui, NewZeland valid upto 29-03-2021 issued by Ministry
manufacturer issued of Health, Newzeland.
by concerned Calcium Chloride Dihydrate: Firm has submitted GMP certificate
regulatory authority (Certificate# HE20180030) issued by Hebei food & Drug
of country of origin. administration valid till 22-04-2023.
Potassium Chloride: Firm has submitted GMP certificate
(Certificate# HE20180030) issued by Hebei food & Drug
Sodium Lactate: Firm has submitted Eudra GMP certificate
(Certificate# NCF-II/1817/001/CAT) is valid till April 2021.
Dextrose anhydrous: Firm has submitted copy of GMP certificate
(Certificate# HE20190013) in the name of M/s CSPC SHENGXUE
Glucose Co., Ltd., No. 48 Shengxue Road, Luancheng District,
Shijiazhuang City, Hebei province, China valid upto 02-02-2024
issued by HEBEI Dug Admiistration.
3. Documents for the Sodium Lactate: Firm has submitted copy of invoice attested by
procurement of API AD DRAP I&E Lahore, M/s Pacific Pharmaceuticals Ltd., 30
with approval from Km, Multan Road, Lahore dated 07-07-2020 specifying the
DRAP (in case of quantity of 800Kgs of Sodium lactate (60%).
import). Calcium Chloride Dihydrate: Firm has submitted copy of invoice
attested by AD DRAP I&E Lahore dated 09-09-2020, M/s Pacific
of 1 MTS.
Potassium Chloride: Firm has submitted copy of invoice attested
by AD DRAP I&E Lahore dated 09-09-2020, M/s Pacific
of 1 MTS.
Dextrose anhydrous: Firm has submitted copy of commercial
invoice (Invoice#. 20ST27003) attested by AD DRAP I&E Lahore,

dated 03-10- 2019, in the name of M/s Pacific Pharmaceuticals
Ltd., 30 Km, Multan Road, Lahore specifying the quantity of
5000Kgs of Dextrose anhydrous (Batch# 201906001) from M/s
CSPC SHENGXUE Glucose Co., Ltd., No. 48 Shengxue Road,
Luancheng District, Shijiazhuang City, Hebei province, China.
4. Data of stability
batches will be
supported by attested
respective Firm has submitted data pf stability batches along with batch
chromatograms,
Raw data sheets,
COA, summary data
sheets etc.
5. Compliance Record
of HPLC software
21CFR & audit trail Not applicable
reports on product
testing.
6. Record of Digital
data logger for
temperature & Firm has submitted Record of Digital data logger for temperature &
humidity monitoring humidity monitoring of stability chambers (real time and
of stability chambers accelerated)
(real time and
accelerated)
Firm’s response:
We Pacific pharmaceuticals Ltd. Ravi Lane Plot No. 384, Sundar Industrial Estate, Raiwind Lahore
Lahore.
our future procurement will be made by Pacific pharmaceuticals Ltd. Ravi Lane Plot No. 384,
Decision of 320th meeting: Approved. Approved. Registration Board further decided that
registration letter will be issued after submission of full fee that is Rs. 30,000/- as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.

Agenda of Evaluator PEC-I
Case No. I: Registration applications of Local Manufacturing submitted on Form 5F (New

Section/New License)
Deferred Cases:
M/s Jaskan Pharmaceuticals (Pvt) Ltd., 50-Sundar Industrial Estate, Lahore was granted additional
section “Injectable vial (General)” vide letter No.F.1-16/2006-Lic(Vol-I) dated 12th March, 2021.
Sr. No. No. of molecules No. of product
1 02 02
7. Name, address of Applicant / Marketing M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-
Authorization Holder Sundar Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-
Sundar Industrial Estate, Lahore.
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 26351 dated 22/09/2021
Details of fee submitted PKR 30,000/-: dated 16/09/2021
The proposed proprietary name / brand
Moxica 400mg Infusion
name
Strength / concentration of drug of Eacxh vial contains:
Active Pharmaceutical ingredient (API) Moxifloxacin as HCl……400mg
per unit
Pharmaceutical form of applied drug Solution for Infusion
Pharmacotherapeutic Group of (API) Antibiotic
In-house
specifications
Proposed Pack size 1’s (250ml)
The status in reference regulatory Avelox 400mg/250mL infusion MHRA
authorities Approved.
For generic drugs (me-too status) Mofest 400mg/250mL Infusion by M/s Sami
Pharmaceuticals Pvt. Ltd. Reg. No. 53227
GMP status of the Finished product Copy of GMP certificate No. 10/2021-
manufacturer DRAP(FID-797667-1346) dated 18/02/2021
issued on the basis of inspection conducted on
26/10/2020.

Name and address of API manufacturer. M/s Vital Laboratories Pvt. Ltd. Plant No. II,
plot No. 1710 & A1/2208, GIDC estate, Phase
III, Vapi-396195 Gujrat, India.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-
PD template. Summarized information related
description of manufacturing process and
controls, specifications, analytical procedures
and its verification, batch analysis and
justification of specification, reference
standard, container closure system and
stability studies of drug substance and drug
product is submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance
data related to nomenclature, structure,
general properties, solubility, physical form,
procedures and its complete validation
studies, batch analysis and justification of
specification, details of reference standards,
container closure system and stability studies
of drug substance.
Stability studies Stability study conditions:
Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months for 3 batches (MOXPB112001,
MOXPB112002, MOXPB112003)
months of 02 batches (MOXPB001,
MOXPB001)
Module-III (Drug Product): The firm has submitted detail of
process and controls, impurities,
specifications, analytical procedure and its
validation studies, batch analysis and
stability studies of drug product.
Pharmaceutical equivalence and Pharmaceutical equivalence studies have been
comparative dissolution profile conducted against Mofest Infusion
400mg/250mL Batch 041G By M/s Sami
Pharmaceuticals.
Analytical method
validation/verification of product
Manufacturer of API M/s Vital Laboratories Pvt. Ltd. Plant No. II, plot No. 1710 &
A1/2208, GIDC estate, Phase III, Vapi-396195 Gujrat, India.
API Lot No. MOX2010023
Description of Pack Type I glass vial with rubber stopper and flip off aluminium seal.

(Container closure
system)
Batch No. KN-01 KN-02 KN-03
Batch Size 100 vials 100 vials 100 vials
No. of Batches 03
1. Reference of previous approval of No response is submitted against this point.
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of drug manufacturing license number
of API manufacturer issued by License Retention/Vital/2019/63520 valid till
concerned regulatory authority of 2024 is submitted.
country of origin.
3. Documents for the procurement of API Invoice No. HHM/2021/00377 (Diary No.
with approval from DRAP (in case of 1447/2021/DRAP) dated 26/01/2021 is
import). submitted.

sheets etc.
5. Compliance Record of HPLC software Submitted.
testing
6. Record of Digital data logger for The firm has submitted record of digital data
temperature and humidity monitoring of logger.
accelerated)
Remarks OF Evaluator:
Observations Response
Please provide analytical method used by The firm has submitted method of analysis
drug product manufacturer for the routine for drug substance used for routine analysis
analysis of drug substance. as per USP.
Submit analytical method verification Analytical method verification studies for
studies including specificity, accuracy and drug substance including specificity,
precision performed by drug product precision and accuracy is submitted.
manufacturer for drug substance.
Since the excipients used in the applied Not submitted.
formulation are different from the excipients
used in manufacturing of reference product,

therefore, provide compatibility studies of
excipients with the drug substance.
The stability summary sheets for drug The firm could not clarify the difference of
substance are from M/s Vital Health Care the address of drug substance manufacturer
Pvt. Ltd. (VAPI) Plot No. 1416-18 & 1507, mentioned in license, form 5F and stability
GIDC Phase III, Vapi 396195 Gujrat, India summary sheets.
while the address of manufacturer of drug
substance as mentioned on DML and Form
5F is different, please clarify.
Clarification is required since The firm has submitted pharmaceutical
pharmaceutical equivalence is established equivalence data against another product
against Mofest 400mg/250mL infusion by Avelox Infusion 400mg/250mL (B:
M/s Sami Pharmaceuticals while the studies BXJE602) by M/s Bayer AG Pharmacutical
should be carried out against the pvt ltd.
reference/innovator’s product.
Please provide detailed calculations for The firm has stated that without considering
quantity to be dispensed per vial considering LOD factor, the assay results are well in
the actual potency of Moxifloxacin HCl limits. The firm has further stated that in
since “loss on drying” has not been future they would consider this factor.
considered.
The stability data is submitted till 3rd month The firm has submitted the stability studies
time point, please provide stability studies till 6th month’s time point.
till 6th month time point.
Provide documents confirming import of the Invoice No. HHM/2021/00377 dated
drug substance used in the manufacturing of 15/01/2021 (Diary No. 1447/2021/DRAP
trial batches. dated 26/01/2021) is submitted.
th
Decision of 316 meeting:
Deferred for clarification of variation in the address of drug substance manufacturer as
mentioned in Drug Manufacturing License, Form 5F and stability summary sheets of the drug
substance.
Submission by the firm:
The firm has stated that M/s Vital Laboratories Pvt. Ltd., India (Previously known as Vital
Health Care Pvt. Ltd., has 3 manufacturing plants. Earlier, DML of plant II was submitted
erroneously. Their latest DML of plant I is submitted, which has same address as on stability
summary sheets of the drug substance.
• Plant I: Plot No. 1416 to 1421 & 1507 /1 & 2, 1601, GIDC Phase III Vapi 396195
Gujrat India.
• Plant II: Plot No. 1710 & A1/2208, GIDC Estate, Phase III, Vapi 396195 Gujarat India.
• Plant III: Plot No. 1302/3, GIDC Estate, Phase III, Vapi 396195 Gujarat India.
The firm has stated that the API used for product development is from plant I. Copy of
Retention of License (No. G/28/1117) is submitted. The license is valid till20/02/2027.
Decision: Approved with innovator’s specifications. Registration Board further decided
that registration letter will be issued after submission of applicable fee that is Rs. 7,500/-
for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
• Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months
as per the commitment submitted in the registration application.
New Cases:
M/s Jaskan Pharmaceuticals (pvt) Ltd. was granted New Section “Injectable (vial) General
Section” vide letter No. F.1-16/2006-Lic (Vol-I) dated 12/03/2021 title of which was corrected

in 283rd meeting of Licensing Board as “Injectable (Vial) (General) (LVP) Section” vide even
letter No. dated 18/111/2021.
Injectable (Vial) (General) (LVP) Section:
The firm has applied for:
Sr. No. No. of Molecules No. of products
1 01 01
8. Name, address of Applicant / Marketing M/s Jaskan Pharmaceutical Private Limited
Authorization Holder Plot No 50 Sunder Industrial Estate Lahore
Name, address of Manufacturing site. M/s Jaskan Pharmaceutical Private Limited
Plot No 50 Sunder Industrial Estate Lahore
☐ Importer
giver)
Intended use of pharmaceutical product ☐Domestic sale
☐ Export sale
Details of fee submitted PKR 30,000/-: dated 03-04-2022
Tramak Infusion 1000mg /100ml
name
Strength / concentration of drug of Each 100 ml Vial contains:
Active Pharmaceutical ingredient (API) Paracetamol ………. 1000mg
per unit
Pharmaceutical form of applied drug Liquid for Infusion
Pharmacotherapeutic Group of (API) Analgesic; antipyretic.
Manufacturer’s specs
specifications
Proposed Pack size 1×1’s
The status in reference regulatory
MHRA Approved
authorities
For generic drugs (me-too status) Provas I.V Infusion 1000 mg M/s Sami
Pharmaceuticals Pvt Ltd. Karachi Pakistan,
Reg. No. 053223
GMP status of the Finished product Certifictae No.10/2021-DRAP (FID-
manufacturer 797667-1346) issued by DRAP valid till
25/10/2022.
Name and address of API manufacturer. Pharmagen Limited Kot Nabi Bukshwala,
34 Km Ferozepur Road, Lahore.
PD template. Summarized information

verification, batch analysis and justification
of specification, reference standard,
of drug substance and drug product is
submitted.
Module III (Drug Substance) The firm as submitted detail of
controls, , specifications, analytical
procedures and its verification, batch
and stability studies of drug substance.
months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for
6 months
Batches: (Lab Experiment/001/2016, Lab
Experiment/002/2016, Lab
Experiment/003/2016)
verification studies, batch analysis and
Pharmaceutical equivalence and Pharmaceutical Equivalence is established
comparative dissolution profile Provas I.V Infusion 1000mg Infusion by
M/S Sami Pharmaceuticals Pvt Ltd.
Karachi Pakistan, Reg. No. 053223 by
performing quality tests. The results of all the
tests of both products fall within the
specifications and are comparable.
Analytical method Firm has submitted reports of verification
validation/verification of product studies of analytical method for the drug
substance.
Firm has also submitted reports of validation
of analytical method for the drug product.
Manufacturer of API Pharmagen Limited Kot Nabi Bukshwala, 34 Km Ferozepur

Road, Lahore.
API Lot No. 00510911-01/002/2021
Description of Pack Colorless glass vial (Type II) with aluminium foil seal and a
transparent white rubber stopper as closure.

(Container closure
system)
Frequency Accelerated: 0, 1, 2, 3, 6 (Months)
Real Time: 0, 3, 6, (Months)
Batch No. LC 01 LC 02 LC 03
No. of Batches 03
1. Reference of previous approval of No response is submitted against this point
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of DML certificate No. 000325 and
of API manufacturer issued by GMP Certificate No. 06-2019-
concerned regulatory authority of DRAP(AD/607409-530, both issued by
country of origin. DRAP.
3. Documents for the procurement of API Firm has submitted copy of invoice
with approval from DRAP (in case of specifying Local Procurement of
import). Paracetamol Invoice No 2129 dated 10-
02-2021.

documents like chromatograms, Raw
etc.
5. Compliance Record of HPLC software The firm has submitted the compliance
21CFR & audit trail reports on product record of HPLC 21CFR software audit trail
testing report for the applied product.
accelerated)
The drug substance is manufactured according to B.P but the data submitted by the finished
product manufacturer shows that USP method is used for routine analysis of Paracetamol
drug substance. However, the method used for analysis of finished product is In-House.
Sr. Observations Response by the firm
No
1 As per available literature, the The firm has submitted the results of
manufacturer of the reference product osmolality test. The test was performed on
has included the test for Osmolality in 16/07/2022.
the finished product specifications
while you have not performed any
such test, please clarify.

2 Cysteine Hydrochloride is used as an The firm has provided reference of another
anti-oxidant in the reference product product “Paracetamol Panpharma 10mg/ml
but you have not used any excipient solution for infusion” approved in France
having a role as anti-oxidant, please where no anti-oxidant is used in the
clarify. formulation.
http://agence-
prd.ansm.sante.fr/php/ecodex/
frames.php?specid=63069892&typedoc=
R&ref=R0378034.htm (Accessed on
25/07/2022)
3 Clarification is required since the “The innovator’s product is not available in
performance of pharmaceutical Pakistan”
equivalence is performed against
Provas infusion by M/s Sami Pharma
but not against the reference /
innovator’s product.
4 Please provide detail of calculations The firm has provided complete
for potency adjustment considering calculations.
the purity of drug substance as per
COA.
5 Justify the stability studies without The firm has submitted revised stability
the performance of Bacterial summary sheets containing the results of
Endotoxin and Sterility testing. sterility testing and Bacterial endotoxin test
without any clarification regarding
previously submitted sheets without these
tests.
that registration letter will be issued after submission of applicable fee that is Rs. 7.500/-
for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
section “DRY POWDER FOR INJECTION (CEPHALOSPORIN)” vide letter No.F.1-16/2006-
Lic(Vol-I) dated 12th March, 2021.
DRY POWDER FOR INJECTION (CEPHALOSPORIN):
After consideration of 02 more applications, the total number of considered molecules/product
will be:
Sr. No. No. of molecules No. of product
1 01 06
☐ Importer
giver)

☐ Export sale
The proposed proprietary name / brand Jaxone Dry Powder for Solution for IV
name Injection 250mg
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient (API) Ceftriaxone as sodium……250mg
per unit
Pharmaceutical form of applied drug Powder for solution for
Pharmacotherapeutic Group of (API) Cephalosporin
USP
specifications
Proposed Pack size 1’s
The status in reference regulatory Ceftriaxone for injection 1g, MHRA
For generic drugs (me-too status) Rocephin 500mg Injection by M/s
MartinDow
issued on the basis of inspection conducted
on 26/10/2020.
Name and address of API manufacturer. M/s Pharmagen Limited Kot Nabi
Bukhshwla, 34 km Ferozepur road, Lahore.
process and controls, specifications,
analytical procedures and its verification,
batch analysis and justification of
substance and drug product is submitted.
analytical procedures and its complete
justification of specification, details of
reference standards, container closure system

months
6 months
Batches: (00241/007/2006, 00241/00/2006,
00241/009/2006)
Pharmaceutical equivalence and Pharmaceutical equivalence is performed
comparative dissolution profile against Oxidil 250mg Injection by M/s Sami
by performing the quality tests. (B:013G).
Analytical method The firm has submitted analytical method
validation/verification of product verification studies including certain testing
parameters such as accuracy, precision and
specificity for drug product and substance
performed by drug product manufacturer.
Manufacturer of API M/s Pharmagen Ltd., Kot Nabi Buksh wala, 34-km, Ferozepur
road, Lahore.
API Lot No. 00421/002/2021
Description of Pack
Type I glass vial (15ml) with rubber stopper and grey flip off
(Container closure
aluminium cap
system)
Batch No. KG-1 KG-2 KG-3
No. of Batches 03
the firm (if any)

8. Approval of API/ DML/GMP certificate GMP certificate No. 06/2019-
of API manufacturer issued by DRAP(AD/607409-530) dated 11/01/2019
concerned regulatory authority of issued on the basis of inspection conducted
country of origin. on 08/01/2019.
9. Documents for the procurement of API The drug substance is locally procured.
with approval from DRAP (in case of
import).

sheets etc.
testing
accelerated)
Sr. Observations Response
no.
1 Justify the performance of stability The firm has submitted revised stability
studies without the performance of summary sheets containing the results of
Bacterial Endotoxin and Sterility sterility testing and Bacterial endotoxin
testing. test without any clarification regarding
tests.
2 The quantity to be dispensed as per The firm has submitted the calculations.
submitted dossier is 299.96mg/vial, The actual quantity to be dispensed should
please submit the detail with be 300.854mg per vial.
justification for dispensed quantity.
3 Provide invoice confirming the The firm has submitted copy of invoice
procurement of Ceftriaxone Sodium. No. 2268 dated 24/02/2021 from M/s
Pharmagen Limited.
4 Oxidil Injection by M/s Sami “Rocephin 250mg is not available in
Pharma is used for pharmaceutical Pakistan”
equivalence testing while the said
studies are required to be performed
against innovator’s/reference
product, please clarify.
Decision: Approved.

☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand Jaxone Dry Powder for Solution for IV
name Injection 500mg
Active Pharmaceutical ingredient (API) Ceftriaxone as sodium……500mg
per unit
Pharmaceutical form of applied drug Powder for solution for
Pharmacotherapeutic Group of (API) Cephalosporin
USP
specifications
The status in reference regulatory Ceftriaxone for injection 1g, MHRA
For generic drugs (me-too status) Rocephin 500mg Injection by M/s
MartinDow
on 26/10/2020.
Name and address of API manufacturer. M/s Pharmagen Limited Kot Nabi
Bukhshwla, 34 km Ferozepur road, Lahore.

analytical procedures and its complete
justification of specification, details of
reference standards, container closure system
months
6 months
Batches: (00241/007/2006, 00241/00/2006,
00241/009/2006)
Pharmaceutical equivalence and Pharmaceutical equivalence is performed
comparative dissolution profile against Rocephin 500mg Injection 1g by M/s
MartinDow by performing the quality tests.
(B:B0067).
validation/verification of product verification studies including certain testing
parameters such as accuracy, precision and
specificity for drug product and substance
performed by drug product manufacturer.
Manufacturer of API M/s Pharmagen Ltd., Kot Nabi Buksh wala, 34-km, Ferozepur
road, Lahore.
API Lot No. 00421/002/2021
Description of Pack
Type I glass vial (15ml) with rubber stopper and green flip off
(Container closure
aluminium cap
system)
Batch No. KG-1 KG-2 KG-3
No. of Batches 03

the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate No. 06/2019-
of API manufacturer issued by DRAP(AD/607409-530) dated 11/01/2019
concerned regulatory authority of issued on the basis of inspection conducted
country of origin. on 08/01/2019.
3. Documents for the procurement of API The drug substance is locally procured.
import).

etc.
testing
accelerated)
No.
1 Justify the stability studies without
The firm has submitted revised stability
the performance of Bacterial summary sheets containing the results of
Endotoxin and Sterility testing. sterility testing and Bacterial endotoxin
test without any clarification regarding
tests.
2 Justify the dispensed quantity The firm has submitted the calculations.
(599.91mg/vial) of Ceftriaxone The actual quantity to be dispensed should
Sodium keeping in view the be 601.685mg per vial.
moisture content as per the
certificate of analysis from drug
product manufacturer.
3 Provide invoice confirming the The firm has submitted copy of invoice
procurement of Ceftriaxone Sodium. No. 2268 dated 24/02/2021 from M/s
Pharmagen Limited.
Decision: Approved.
section “Injectable (Ampoule) General Section” vide letter No.F.1-16/2006-Lic(Vol-I) dated 12th
March, 2021.
Injectable (Ampoule) General Section:

01 product and 01 molecules is considered by the board already. The firm has applied for 02 more
product and after consideration of two more products the detail of total number of
molecules/products will be:
No. of Molecules No. of products
02 03
11. Name, address of Applicant / M/s Jaskan Pharmaceuticals (Pvt.) Ltd., 50-
Marketing Authorization Holder Sundar Industrial Estate, Lahore.
☐ Importer
giver)
Aqua J 10ml Injection
brand name
Strength / concentration of drug of Each ampoule contains:
Active Pharmaceutical ingredient Sterile Water for injection…..10ml
(API) per unit
Pharmaceutical form of applied drug Clear, colorless water for injection
Pharmacotherapeutic Group of (API) Water for injection/diluent/solvent
Reference to Finished product B.P
specifications
The status in reference regulatory Sterile water for injection 10ml glass
authorities ampoule by M/s Hameln Pharma Ltd,
MHRA Approved.
For generic drugs (me-too status) Water for injection 10ml by M/s Healthtek,
Reg. No. 076482
on 26/10/2020.
Dry powder
Name and address of API N/A
manufacturer.
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-
Summary) PD template. Firm has summarized
information related to nomenclature,
structure, general properties, solubility,

manufacturing process and controls,
impurities, specifications, analytical
procedures and its validation, batch analysis
and justification of specification, reference
stability studies of the product.
Module III (Drug Substance) Firm has submitted detailed data of drug
substance related to nomenclature, structure,
general properties, solubilities, description
of manufacturing process and controls,
specifications, analytical procedures, batch
analysis and justification of specification
and container closure system.
Stability studies N/A
Module-III (Drug Product): Firm has submitted data of drug product
specifications, analytical procedures,
validation of analytical procedures, batch
analysis, justification of specifications,
reference standard or materials, container
closure system and stability.
Pharmaceutical equivalence and The firm has submitted pharmaceutical
comparative dissolution profile equivalence testing data against WFI 10ml
injection by M/s Healthtek by performing all
the quality tests (027H).
Analytical method N/A
Manufacturer of API N/A

API Lot No. N/A
Description of Pack
(Container closure Glass AMpoule
system)
Frequency Accelerated: 0, 3 (Months)
Batch No. KV-01 KV-02 KV-03
Batch Size 1000 injection 1000 ampoules 1000 ampoules
Manufacturing Date March, 2021 March, 2021 March, 2021
Date of Initiation 30/03/2021 30/03/2021 30/03/2021

No. of Batches 03
1. Reference of previous approval of Aqua J 5ml Injection approved in 313th
applications with stability study data meeting.
2. Approval of API/ DML/GMP N/A
certificate of API manufacturer issued
by concerned regulatory authority of
country of origin.
3. Documents for the procurement of N/A
API with approval from DRAP (in
case of import).
4. Data of stability batches will be Firm has submitted stability study data of 3
supported by attested respective batches along with water loss test at each
documents like chromatograms, Raw time point. Firm has submitted analytical
data sheets, COA, summary data report at each stability testing interval.
sheets etc.
5. Compliance Record of HPLC N/A
on product testing
temperature and humidity monitoring logger.
of stability chambers (real time and
accelerated)
Remarks OF Evaluator-I:
Decision: Approved.
12. Name, address of Applicant / Marketing M/s Jaskan Pharmaceutical Private Limited
Authorization Holder Plot No 50 Sunder Industrial Estate Lahore
Name, address of Manufacturing site. M/s Jaskan Pharmaceutical Private Limited
Plot No 50 Sunder Industrial Estate Lahore
☐ Importer
giver)
☐ Export sale
JD-3 Injection 5mg/mL IM/Oral
name

Strength / concentration of drug of Each Ampoule (1mL) contains:
Active Pharmaceutical ingredient (API) Cholecalciferol ............. 5mg
per unit
Pharmaceutical form of applied drug Solution for IM Injection/Oral
Pharmacotherapeutic Group of (API) Vitamin
Innovator’s Specs
specifications
Proposed Pack size 1ml(1x1,s)
The status in reference regulatory Vitamin D3 Bon 200000 IU /1mL
authorities Solution for injection, ANSM France
Approved.
For generic drugs (me-too status) Indrop D Injection M/s Neutro
Pharmaceutical Pvt Ltd Pakistan., Reg. No.
023170
GMP status of the Finished product New Section Approval granted on 12-03-
manufacturer 2021
(Injectable General Ampoule & Injectable
General vials) section approved.
Name and address of API manufacturer. Sichuan Yuxin Pharmaceutical Co. Ltd
No 51 West Section Of Changjiang Road
Shifang Economic Delopment Zone
Southern District) Sichuan China.
submitted.
controls, specifications, analytical
and stability studies of drug substance
Real time: 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
The firm has submitted stability data of
cholecalciferol in different container closure
with the following details

• Packed under vacuum in glass ampoule
(36months real time and 6 months
accelerated)
B: CHL0408020, CHL0408021,
CHL0408022
• Packed in LDPE bag under vacuum
(36months real time and 6 months
accelerated)
B: CHL0411028, CHL0411029,
CHL0411030
• Packed in aluminium bottle under inert
gas (36months real time and 6 months
accelerated)
B: CHL040802, CHL0408021,
CHL0408022
comparative dissolution profile against the brand leader that is Indrop D
Injection M/s Neutro Pharmaceutical Pvt
Ltd Pakistan. B. No. HP933, by performing
quality tests.
Analytical method Method validation studies are submitted
validation/verification of product including linearity, range, accuracy,
precision, specificity.
Manufacturer of API Sichuan Yuxin Pharmaceutical Co. Ltd

No 51 West Section Of Changjiang Road Shifang Economic
Development Zone (Southern District) Sichuan China.
API Lot No. VD3210701
Description of Pack
(Container closure Clear glass USP type 1 in unit carton (1×1’s)
system)
Batch No. DK 01 DK 02 DK 03
Batch Size 100 Ampoule 100 Ampoule 100 Ampoule

No. of Batches 03
1. Reference of previous approval of No response is submitted.
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of DML No. 20160429 valid till
of API manufacturer issued by 1/10/2025 is submitted.
concerned regulatory authority of
country of origin.
3. Documents for the procurement of API Copy of AD attested invoice No.
with approval from DRAP (in case of XS21804581 dated 21/08/2021 dy. No.
import). 3571/2021-DRAP dated 09/09/2021.

etc.
5. Compliance Record of HPLC software Submitted
testing
accelerated)
No.
1 Please submit the Compliance Record “We are using EZ chrome light software for
of HPLC software 21CFR & audit trail our testing which is in 21CFR compliance”.
reports on product testing The firm has submitted the audit trail
report.
2 Provide analytical method Analytical verification studies for drug
validation/verifications studies substance from drug product manufacturer
including specificity, precision and are submitted including specificity,
accuracy for Drug substance along accuracy and precision.
with the method of analysis used for
routine analysis of drug substance.
3 The submitted stability data for the The applicant has submitted stability data at
applied product is till 3rd month time 6th month time for all the 03 batches for
point, please submit stability data till 6 accelerated and real time stability studies.
months. Moreover, justification is The tests for sterility and BET are included
required is require for not performing at 6th month time point testing.
the tests for sterility and bacterial
endotoxins in stability studies.
4 Provide documents confirming the Copy of ADC attested invoice No.
import/procurement of drug substance XS21804581 dated 21/08/2021 dy. No.
used for the development of applied 3571/2021-DRAP dated 09/09/2021.
product.
5 Provide complete calculations for Calculations for potency adjustment is
potency adjustment. submitted.
Decision: Approved.

M/s Qadir Pharmaceuticals, Veerum Fateh Garh Sahuwala Road, Sialkot has been granted with
Drug Manufacturing License vide letter No. F.1-5/2017-Lic dated 17/09/2021.
Dry Powder Injectable Section (Cephalosporin):
The firm has applied for 01 molecule and 07 product in Dry Powder Injectable Section
(Cephalosporin).
13. Name, address of Applicant / Marketing M/s Qadir Pharmaceuticals, Veerum Fateh
Authorization Holder Garh Sahuwala Road, Sialkot.
Name, address of Manufacturing site. M/s Qadir Pharmaceuticals, Veerum Fateh
Garh Sahuwala Road, Sialkot.
☐ Importer
giver)
GMP status of the firm Firm has been granted new license (DML No.
000944) by way of formulation dated 14-09-
2021.
Evidence of approval of manufacturing Firm has submitted copy of letter of issuance
facility of DML dated 17-09-2021 which specifies
Dry powder injectable (Cephalosporin)
section.
☐ Export sale
Dy. No. and date of submission Dy. No. 17593: 16/06/2022
Details of fee submitted PKR 30,000/-: 13/05/2022
The proposed proprietary name / brand QXON 250mg Injection IM
name
Strength / concentration of drug of Active Each Vial Contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……250mg
Pharmaceutical form of applied drug Sterile white to off white / yellowish
crystalline powder filled in transparent glass
vials
Pharmacotherapeutic Group of (API) Cephalosporin antibiotic
specifications
The status in reference regulatory Ceftriaxone sodium Injection (MHRA
authorities Approved)

For generic drugs (me-too status) Rocephin injection by Roche.
Name and address of API manufacturer. Pharmagen Ltd. Kot Nabi Buksh Wala 34-
Km, Ferozepur Road, Lahore.
PD template. Firm has summarized
product.
Module-III Drug Substance: Firm has submitted detailed data for both
drug substance data related to nomenclature,
stability studies of drug substance.
(Conditions & duration of Stability batches of drug substance at both accelerated
studies) as well as real time conditions. The
accelerated stability data is conducted at 40oC
± 2oC / 75% ± 5% RH for 6 months. The real
time stability data is conducted at 30oC ± 2oC
/ 65% ± 5% RH for 36 months.
Firm has also submitted compatibility studies
of the drug product along with the
recommended diluent i.e. 1% lignocaine
hydrochloride injection.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical
Comparative Dissolution Profile equivalence for all the quality tests defined in
USP for their product against the comparator
i.e. Oxidil 250mg Injection of M/s Sami
Pharmaceuticals.

Analytical method validation/verification Firm has submitted report of verification of
of product analytical method for the drug substance.
Firm has submitted report of verification of
analytical method for the drug product.
Manufacturer of API Pharmagen Ltd. Kot Nabi Buksh Wala 34-Km, Ferozepur Road,
Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Batch No. T001 T002 T003
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED ALONG WITH STABILITY STUDY DATA
1. Reference of previous approval of Qadir Pharmaceutical is a new License facility
applications with stability study data of the hence no such inspection has been conducted
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate
API manufacturer issued by concerned issued by Additional Director DRAP, Lahore
regulatory authority of country of origin. dated 02-09-2020. The GMP certificate was
granted based on inspection dated 22-06-
2020.
3. Documents for the procurement of API with Firm has submitted copy of commercial
approval from DRAP (in case of import). invoice specifying purchase of 10Kg
Ceftriaxone sodium (sterile) dated 28-09-
2021 lot number 00421/039/2021 from
Pharmagen Limited.
4. Data of stability batches will be supported by Firm has submitted complete record of
attested respective documents like testing of all batches along with
chromatograms, Raw data sheets, COA, chromatograms, raw data sheets, COA and
summary data sheets etc. summary data sheets.
5. Compliance Record of HPLC software Firm has submitted that their HPLC system is
21CFR & audit trail reports on product not 21 CFR compliant.
testing
6. Record of Digital data logger for Firm has submitted record of digital data
temperature and humidity monitoring of logger for temperature and humidity
stability chambers (real time and monitoring of real time and accelerated
accelerated) stability chambers.

Evaluation by PEC:
Sr. Shortcomings communicated Response by the firm

No
1. Submit data in section 3.2.S.4.1 and Firm has submitted drug substance
3.2.S.4.2 as per the guidance document specifications from both API
approved by Registration Board which manufacturer as well as Qadir
specifies that “Copies of the Drug Pharmaceuticals.
substance specifications and analytical
procedures used for routine testing of the
Drug substance /Active Pharmaceutical
Ingredient by both Drug substance &
Drug Product manufacturer is required.”
2. Submit data of verification of analytical Firm has submitted report of
procedure of drug substance in section verification studies of the analytical
3.2.S.4.3 as per the guidance document method of drug substance performed by
approved by Registration Board which Qadir Pharmaceuticals.
specifies that “Analytical Method
Verification studies including specificity,
accuracy and repeatability (method
precision) performed by the Drug Product
manufacturer for both compendial as well
as non-compendial drug substance(s)
shall be submitted”.
3. Submit COA of reference standard Firm has submitted COA of working
actually used in the analysis of drug standard from Pharmagen Limited.
substance in section 3.2.S.5.
4. Justify why pharmaceutical equivalence is Firm has submitted that since the
not conducted against the innovator reference product is not available in
product for 250mg Injection market therefore we have used
comparator product for pharmaceutical
equivalence studies.
5. USP monograph specifies two different Firm has submitted that we have
sample solutions as well as two different performed both these tests as per USP
analysis, calculation formula and but at different stages.
acceptance criteria for assay test, while As our drug product is constituted
your specifications does not specify two solution therefore we have used the test
different tests and acceptance criteria for of constituted solution (sample solution
assay and you have released your batches 2) at finished product stage.
with only 1 type of assay results. Justify The other test specified in USP (Sample
why your specifications, analytical solution 1) was performed at drug
method and practices of batch release are substance stage before filling in the drug
not aligned with USP monograph product.
recommendations.
6. Justify how a single validation studies are Firm has submitted that we have
used for all strengths of ceftriaxone performed verification studies for all
injection since USP monograph specifies strengths and route of administration.
different analytical method for each Firm has submitted verification studies
strength. for each product.
7. Provide documents for the procurement of API is locally procured from M/s
relevant lot(s) of API used in the Pharmagen.
manufacturing of 3 batches of drug
product for which stability studies data is
submitted in section 3.2.P.8.3.

Decision: Approved.
14. Name, address of Applicant / Mar keting M/s Qadir Pharmaceuticals, Veerum Fateh
☐ Importer
giver)
2021.
section.
☐ Export sale
The proposed proprietary name / brand QXON 500mg Injection IM
name
vials
specifications

product.
/ 65% ± 5% RH for 36 months.
i.e. Rocephin 500mg Injection of M/s Martin
Dow Ltd Pakistan.

Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials
No. of Batches 03
firm (if any)
2020.
approval from DRAP (in case of import). invoice specifying import of 10Kg
2020.
testing
Evaluation by PEC:
Sr. No Shortcomings communicated Response by the firm

3.2.S.4.3 as per the guidance document method of drug substance performed
approved by Registration Board which by Qadir Pharmaceuticals.
Verification studies including
specificity, accuracy and repeatability
(method precision) performed by the
Drug Product manufacturer for both
compendial as well as non-compendial
drug substance(s) shall be submitted”.
with only 1 type of assay results. Justify The other test specified in USP
why your specifications, analytical (Sample solution 1) was performed at
method and practices of batch release are drug substance stage before filling in
not aligned with USP monograph the drug product.
recommendations.
5. Justify how a single validation studies Firm has submitted that we have
are used for all strengths of ceftriaxone performed verification studies for all
6. Provide documents for the procurement API is locally procured from M/s
of relevant lot(s) of API used in the Pharmagen.
Decision: Approved.
☐ Importer

giver)
2021.
section.
☐ Export sale
The proposed proprietary name / brand QXON 1g Injection IM
name
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……1g
vials
specifications
product.

/ 65% ± 5% RH for 36 months.
i.e. Rocephin 1g Injection of M/s Martin Dow
Pakistan.
Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials

No. of Batches 03
firm (if any)
2020.
2020.
testing
Evaluation by PEC:
3.2.S.4.2 as per the guidance document specifications from both API manufacturer
approved by Registration Board which as well as Qadir Pharmaceuticals.
specifies that “Copies of the Drug
Pharmaceutical Ingredient by both
Drug substance & Drug Product
manufacturer is required.”
2. Submit data of verification of analytical Firm has submitted report of verification
procedure of drug substance in section studies of the analytical method of drug
3.2.S.4.3 as per the guidance document substance performed by Qadir
approved by Registration Board which Pharmaceuticals.

4. USP monograph specifies two different Firm has submitted that we have performed
sample solutions as well as two both these tests as per USP but at different
different analysis, calculation formula stages.
and acceptance criteria for assay test, As our drug product is constituted solution
while your specifications does not therefore we have used the test of
specify two different tests and constituted solution (sample solution 2) at
acceptance criteria for assay and you finished product stage.
have released your batches with only 1 The other test specified in USP (Sample
type of assay results. Justify why your solution 1) was performed at drug
specifications, analytical method and substance stage before filling in the drug
practices of batch release are not product.
aligned with USP monograph
recommendations.
5. Justify how a single validation studies Firm has submitted that we have performed
are used for all strengths of ceftriaxone verification studies for all strengths and
injection since USP monograph route of administration. Firm has submitted
specifies different analytical method for verification studies for each product.
each strength.
product for which stability studies data
is submitted in section 3.2.P.8.3.
Decision: Approved.
☐ Importer
giver)
2021.
section.

☐ Export sale
The proposed proprietary name / brand QXON 250mg Injection IV
name
vials
specifications
product.

/ 65% ± 5% RH for 36 months.
recommended diluent i.e. water for injection.
i.e. Oxidil 250mg Injection of M/s Sami
Pharma.
Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials
No. of Batches 03
firm (if any)

2020.
2020.
testing
Evaluation by PEC:

2. Submit data of verification of analytical Firm has submitted report of verification
procedure of drug substance in section studies of the analytical method of drug
3.2.S.4.3 as per the guidance document substance performed by Qadir
approved by Registration Board which Pharmaceuticals.
4. Justify why pharmaceutical equivalence Firm has submitted that since the
is not conducted against the innovator reference product is not available in
product for 250mg Injection market therefore we have used
comparator product for pharmaceutical
equivalence studies.

sample solutions as well as two different performed both these tests as per USP but
analysis, calculation formula and at different stages.
your specifications does not specify two solution therefore we have used the test of
different tests and acceptance criteria for constituted solution (sample solution 2) at
assay and you have released your batches finished product stage.
with only 1 type of assay results. Justify The other test specified in USP (Sample
why your specifications, analytical solution 1) was performed at drug
method and practices of batch release are substance stage before filling in the drug
not aligned with USP monograph product.
recommendations.
Decision: Approved.
17. Name, address of Applicant / Marketing M/s Qadir Pharmaceuticals, Veerum Fateh
☐ Importer
giver)
2021.
section.
☐ Export sale

The proposed proprietary name / brand QXON 500mg Injection IV
name
vials
specifications
product.
/ 65% ± 5% RH for 36 months.

i.e. Rocephin 500mg Injection of M/s Martin
Dow Pakistan.
Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials
No. of Batches 03
firm (if any)
2020.

2020.
testing
Evaluation by PEC:
recommendations.

Decision: Approved.
☐ Importer
giver)
2021.
section.
☐ Export sale
Dy. No. and date of submission Dy. No. 17596 16/06/2022
The proposed proprietary name / brand QXON 1g Injection IV
name
vials
specifications

product.
/ 65% ± 5% RH for 36 months.

i.e. Rocephin 1g Injection of M/s Martin Dow
Pakistan.
Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials
No. of Batches 03
firm (if any)
2020.
2020.
testing

Evaluation by PEC:
your specifications does not specify two solution therefore we have used the
different tests and acceptance criteria for test of constituted solution (sample
assay and you have released your batches solution 2) at finished product stage.
recommendations.
different analytical method for each Firm has submitted verification
strength. studies for each product.
Decision: Approved.

☐ Importer
giver)
2021.
section.
☐ Export sale
Dy. No. and date of submission Dy. No. 17598 : 16/06/2022
The proposed proprietary name / brand QXON 2g Injection IV
name
vials
specifications

product.
/ 65% ± 5% RH for 36 months.
i.e. Oxidil 2g Injection of M/s Sami Pharma.
Lahore.
API Lot No. 00421/039/2021
Description of Pack
Glass vials

No. of Batches 03
firm (if any)
2020.
2020.
testing
Evaluation by PEC:
3.2.S.4.3 as per the guidance document

approved by Registration Board which method of drug substance performed
specifies that “Analytical Method by Qadir Pharmaceuticals.
your specifications does not specify two solution therefore we have used the
different tests and acceptance criteria for test of constituted solution (sample
assay and you have released your batches solution 2) at finished product stage.
recommendations.
different analytical method for each Firm has submitted verification
strength. studies for each product.
Decision: Approved.
New Section
M/s Ferozsons Laboratories Ltd, Amangarh Nowshera was granted additional Tablet General
section vide letter no.F.3-14/2004-Lic(Pt) dated 09/04/2020.
The firm has applied for 04 products and 02 molecules.
20. Name, address of Applicant / M/s Ferozsons Laboratories Limited P.O
Marketing Authorization Holder Ferozsons, Amangarh, Nowshera, Khyber
Pakhtunkhwa-Pakistan
Name, address of Manufacturing site. M/s Ferozsons Laboratories Limited P.O
Ferozsons, Amangarh, Nowshera, Khyber
Status of the applicant  Manufacturer
☐ Importer

giver)
 Generic Drug Product (GDP)
 Domestic and Export sales
Details of fee submitted PKR 30,000/- dated 10/05/2022
Vonesta 10mg Tablet
brand name
Strength / concentration of drug of Each film coated tablet contains:
Active Pharmaceutical ingredient Vonoprazan as fumarate……10mg
(API) per unit
Pharmaceutical form of applied drug Round, Film coatedTablet
Pharmacotherapeutic Group of (API) PPIs
Innovator’s
specifications
Proposed Pack size 10’s, 14’s, 20’s, 28’s, 30’s
The status in reference regulatory Takecab Tablets (10mg+20mg) approved by
authorities PMDA
For generic drugs (me-too status) Vonozan 10mg by Getz Pharma
GMP status of the Finished product GMP certificate No. F.11-6/2019-DRAP -06
manufacturer granted on 29-01-2019 valid upto 25-01-2022.
Tablet section (General) approved vide letter
No.F.3-14\2004-Lic Dated: 08-04-2015 is
submitted
Name and address of API M/s Ami Life Sciences Private Limited, Block
manufacturer. No. 82/B, ECP road, At & Post: Karakhadi
391450 Taluka Padra, District Vadodara
Gujarat, India.
template. Summarized information related to
controls, impurities, specifications, analytical
procedures and its verification, batch analysis
studies of drug substance and drug product is
submitted.
Module III (Drug Substance) The firm has submitted detail of nomenclature,
manufacturing process and controls, tests for
impurity (I, II, III, IV, V, VI) individual

procedures for assay of drug substance and
content of Fumaric Acid along with the
studies of drug substance is submitted
Stability studies Real time: 30°C ± 2°C / 65% ± 5%RH for 24
months of 3 batches
months of 3 batches
Batches: (VPF/RD/31800819,
VPF/RD/31810819, VPD/RD/31820819)
procedure for active and related substances and
relevant verification studies, batch analysis and
studies of drug product.
Pharmaceutical equivalence and The applicant has established pharmaceutical
comparative dissolution profile equivalence against Takecab Tablet 10mg (B:
517929) manufactured by M/s Takeda
Pharamceuticals, PMDA Japan.
Comparative dissolution profile against the
innovator’s product (Takecab 10mg,
B:571929) in all the 03 media (0.1N HCl,
acetate Buffer, Phosphate Buffer) is submitted.
F2 values are more than 50.
Analytical method Method validation studies have submitted
validation/verification of product including linearity, range, accuracy, precision,
specificity.
Manufacturer of API M/s Ami Life Sciences Private Limited, Block No. 82/B, ECP
road, At & Post: Karakhadi 391450 Taluka Padra, District
Vadodara Gujarat, India.
API Lot No. VPF/30021020
Description of Pack 03 Alu-pvdc blisters of 10 tablets packed in cardboard box
(Container closure system) (30 tablets)
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
Batch No. VFTTab-001 VFTTab-002 VFTTab-003
Batch Size 2000 tablets 2000 tablets 2000 tablets

No. of Batches 03
1. Reference of previous approval of Empagen tablet 10mg
applications with stability study data of Approved in 294th meeting of RB
the firm (if any) Inspection date: 25/10/20219
Asp per report, the HPLC system is 21CFR
compliant.
2. Approval of API/ DML/GMP Copy of GMP certificate No. 22043267 issued
certificate of API manufacturer issued on the basis of inspection conducted on 04-
by concerned regulatory authority of 05/04/2022 valid till 17/04/2025 issued by food
country of origin. & Drugs Control Administration Gujarat.
3. Documents for the procurement of API Copy of attested invoice No. EXP/1/21-
with approval from DRAP (in case of 22/0108 dated 07/06/2021 (Dy. No. 1771 dated
import). 24/06/2021).
sheets etc.
testing
6. Record of Digital data logger for submitted
temperature and humidity monitoring
accelerated)
Remarks by PEC-I:
No.
1 As per the unit formula the final The firm has submitted revised calculations for
quantity of Vonoprazan fumarate to be potency adjustment. The amount of API to be
dispensed is 13.563mg, please justify dispensed is 13.605mg while 13.563mg was
considering the assay value 98.2% (as dispensed without considering w.c (water
is basis). content). The difference is 0.31%.
2 Please justify the selection of The firm has stated that dissolution data is not
dissolution parameters that is available in any reference regulatory authority
dissolution medium, dissolution nor the drug product is pharmacopoeial,
apparatus, rpm etc. however following justification is provided.
• 6.8 Phopshate Buffer (Medium), The
durg substance is found to be highly
soluble in all physiological pH ranges.
• USP type II apparatus (as per USP
<1092>
• 50rpm-lowest rpm for paddle apparatus
• 900mL volume
• 15mins sampling time-on the basis of
CDP
Decision: The Board was apprised that the calculations for potency adjustment are not
appropriate. The Board discussed the matter in detail and decided to approve the case
with the directions that the applicant will adopt the correct calculations for potency
adjustment for commercial manufacturing.

☐ Importer
giver)
Vonesta 20mg Tablet
brand name
Active Pharmaceutical ingredient Vonoprazan as fumarate……20mg
(API) per unit
Pharmaceutical form of applied drug Round, Film coatedTablet
Pharmacotherapeutic Group of (API) PPIs
Innovator’s
specifications
The status in reference regulatory Takecab Tablets (10mg+20mg) approved by
authorities PMDA
For generic drugs (me-too status) Vonozan 20mg by Getz Pharma
No.F.3-14\2004-Lic Dated: 08-04-2015 is
submitted
Name and address of API M/s Ami Life Sciences Private Limited, Block
manufacturer. No. 82/B, ECP road, At & Post: Karakhadi
391450 Taluka Padra, District Vadodara
Gujarat, India.

submitted.
impurity (I, II, III, IV, V, VI) individual
procedures for assay of drug substance and
content of Fumaric Acid along with the
studies of drug substance is submitted
months of 3 batches
months of 3 batches
Batches: (VPF/RD/31800819,
VPF/RD/31810819, VPD/RD/31820819)
Pharmaceutical equivalence and The applicant has established pharmaceutical
comparative dissolution profile equivalence against Vonozan 20mg (B:
006FF9) manufactured by M/s Getz Pharma.
Comparative dissolution profile against the
innovator’s product (Vonozan 20mg (B:
006FF9) manufactured by M/s Getz Pharma/)
in all the 03 media (0.1N HCl, acetate Buffer,
Phosphate Buffer) is submitted. F2 values are
more than 50.
specificity.
Manufacturer of API M/s Ami Life Sciences Private Limited, Block No. 82/B, ECP
road, At & Post: Karakhadi 391450 Taluka Padra, District
API Lot No. VPF/30021020

Description of Pack 03 Alu-pvdc blisters of 10 tablets packed in cardboard box
(Container closure system) (30 tablets)
Batch No. VFTTab-001 VFTTab-002 VFTTab-003
No. of Batches 03
compliant.
2. Approval of API/ DML/GMP Copy of GMP certificate No. 22043267 issued
certificate of API manufacturer issued on the basis of inspection conducted on 04-
by concerned regulatory authority of 05/04/2022 valid till 17/04/2025 issued by food
country of origin. & Drugs Control Administration Gujarat.
3. Documents for the procurement of API Copy of attested invoice No. EXP/1/21-
with approval from DRAP (in case of 22/0108 dated 07/06/2021 (Dy. No. 1771 dated
import). 24/06/2021).
sheets etc.
testing
accelerated)
Remarks by PEC-I:
No.
1 As per the unit formula the final The firm has submitted revised calculations for
quantity of Vonoprazan fumarate to be potency adjustment. The amount of API to be
dispensed is 27.127mg, please justify dispensed is 27.210mg while 27.127mg was
considering the assay value 98.2% (as dispensed without considering w.c. The
is basis). difference is 0.305%.
2 Please justify the selection of The firm has stated that dissolution data is not
dissolution parameters that is available in any reference regulatory authority

dissolution medium, dissolution nor the drug product is pharmacopoeial,
apparatus, rpm etc. however following justification is provided.
• 6.8 Phopshate Buffer (Medium), The
durg substance is found to be highly
soluble in all physiological pH ranges.
• USP type II apparatus (as per USP
<1092>
• 50rpm-lowest rpm for paddle apparatus
• 900mL volume
• 15mins sampling time-on the basis of
CDP
3 Pharmaceutical equivalence testing The firm has submitted the required data of
and CDP have been performed against CDP and pharmaceutical equivalence against
Vonozan by Getz Pharma while the the reference product that is Takecab 20mg
said testing should be performed tablet (B:517196) PMDA Japan approved.
against the innovator’s / reference
product, please clarify.
☐ Importer
giver)
XIna 2.5mg tablet
brand name
Active Pharmaceutical ingredient Apixaban……..2.5mg
(API) per unit
Pharmaceutical form of applied drug Round, immediate release, film coated tablet

Pharmacotherapeutic Group of (API) Anti-thormbotic agent
Innovator’s specs
specifications
Eliquis (2.5 & 5mg) Tablet, USFDA Approved.
authorities
For generic drugs (me-too status) Zilero 2.5mg tablet by M/s Pharmevo Reg.
No. 105254
No.F.3-14\2004-Lic Dated: 08-04-2015 is
submitted
Name and address of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd.,
manufacturer. Jiangxi Fengxin Industrial Park, Fengxin
330700, Jiangxi Province, China.
controls, impurities and residual solvents,
verification, batch analysis and justification of
Module III (Drug Substance) It is classified as BCS class II drug. No official
monograph is available. The firm has submitted
detail of nomenclature, structure, general
process and controls, tests for impurities,
specifications, analytical procedures for assay
of drug substance and content of Fumaric Acid
along with the verification studies, batch
and stability studies of drug substance is
submitted
months of 3 batches
months of 3 batches
Batches: (20180201Y, 20180202Y,
20180203Y)

Pharmaceutical equivalence and Comparative dissolution profile is submitted
comparative dissolution profile agaisnt the innovator’s product Eliquis 2.5mg
tablet by M/s Bristol Mayors Squib, USFDA
Approved in all the 03 media that is 0.1N HCl,
Acetate Buffer and Phosphate Buffer.
(B:ABB2239).
Pharmaceutical equivalence is established
against the innovator’s product (Eliquis 5mg
Tablet) by performing all the quality tests
B:ABB6690.
specificity.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd., Jiangxi
Fengxin Industrial Park, Fengxin 330700, Jiangxi Province,
China.
API Lot No. 10200301Y
Description of Pack
Alu-Pvdc blister, Packed in outer (secondary) cardbox.
Batch No. ADTab-001 ADTab-002 ADTab-003
No. of Batches 03
compliant.
8. Approval of API/ DML/GMP Copy of GMP Pharmaceutical Production
certificate of API manufacturer issued License No. GAN20160125 is submitted which
by concerned regulatory authority of is valid till 26/11/2025 issued by provincial
country of origin. Medical Products Administration.
9. Documents for the procurement of API Copy of attested invoice is submitted (Dy. No.
with approval from DRAP (in case of 5160 dated 30/12/2020, DRAP Peshawar).
import).

sheets etc.
testing
accelerated)
Remarks by PEC-I:
No.
1 Please provide the reference for The firm has provided reference from USFDA
adaptation of dissolution specifications dissolution data base and provided the
including paddle speed (75rpm). following weblink.
https://www.accessdata.fda.gov/
scripts/cder/dissolution/dsp_SearchResults.cfm
2 Provide justification of all the The firm has provided justification for
specifications in the relevant section specification for drug product is submitted.
(3.2.P.5.6).
3 Calculations for potency adjustment. The difference in the calculation for potency
adjustment is 0.596%.
☐ Importer
giver)

XIna 5mg tablet
brand name
Active Pharmaceutical ingredient Apixaban……..5mg
(API) per unit
Pharmaceutical form of applied drug Round, immediate release, film coated tablet
Pharmacotherapeutic Group of (API) Anti-thormbotic agent
Innovator’s specs
specifications
Eliquis (2.5 & 5mg) Tablet, USFDA Approved.
authorities
For generic drugs (me-too status) Zilero 5mg tablet by M/s Pharmevo Reg. No.
105255
No.F.3-14\2004-Lic Dated: 08-04-2015 is
submitted
Name and address of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd.,
manufacturer. Jiangxi Fengxin Industrial Park, Fengxin
330700, Jiangxi Province, China.
controls, impurities and residual solvents,
Module III (Drug Substance) It is classified as BCS class II drug. No official
monograph is available. The firm has submitted
process and controls, tests for impurities,
specifications, analytical procedures for assay
of drug substance and content of Fumaric Acid
along with the verification studies, batch
and stability studies of drug substance is
submitted
months of 3 batches

months of 3 batches
Batches: (20180201Y, 20180202Y,
20180203Y)
comparative dissolution profile against the innovator’s product Eliquis 5mg
tablet by M/s Bristol Mayors Squib, USFDA
Approved in all the 03 media that is 0.1N HCl,
Acetate Buffer and Phosphate Buffer.
(B:ABB6690).
against the innovator’s product (Eliquis 5mg
Tablet) by performing all the quality tests
B:ABB6690.
specificity.
Manufacturer of API M/s Jiangxi Synergy Pharmaceutical Co., Ltd., Jiangxi
Fengxin Industrial Park, Fengxin 330700, Jiangxi Province,
China.
API Lot No. 10200301Y
Description of Pack
Alu-Pvdc blister, Packed in outer (secondary) cardbox.
Batch No. ADTab-004 ADTab-005 ADTab-006
No. of Batches 03
compliant.

2. Approval of API/ DML/GMP Copy of GMP Pharmaceutical Production
certificate of API manufacturer issued License No. GAN20160125 is submitted which
by concerned regulatory authority of is valid till 26/11/2025 issued by provincial
country of origin. Medical Products Administration.
3. Documents for the procurement of API Copy of attested invoice is submitted (Dy. No.
with approval from DRAP (in case of 5160 dated 30/12/2020, DRAP Peshawar).
import).
sheets etc.
testing
accelerated)
Remarks by PEC-I:
No.
1 Please provide the reference for The firm has provided reference from USFDA
adaptation of dissolution specificationsdissolution data base and provided the
including paddle speed (75rpm). following weblink.
https://www.accessdata.fda.gov/
scripts/cder/dissolution/dsp_SearchResults.cfm
2 Provide justification of all the The firm has provided justification for
specifications in the relevant section specification for drug product is submitted.
(3.2.P.5.6).
3 Calculations for potency adjustment. The difference in the calculation fir potency
adjustment is 0.596%.
Case No. II: Cases of local manufacturing submitted on Form 5F

24. Name, address of Applicant / Marketing M/s Horizon Healthcare Pvt., Ltd., Plot # 33,
Authorization Holder Sundar Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Horizon Healthcare Pvt., Ltd., Plot # 33,
Sundar Industrial Estate Lahore.
☐ Importer
giver)

☐ Export sale
Azilsartan Medoxomil 40mg Tablet
name
Strength / concentration of drug of Each tablet contains:
Active Pharmaceutical ingredient (API) Azilsartan Medoxomil as
per unit Potassium…….40mg
Pharmaceutical form of applied drug Tablet
Pharmacotherapeutic Group of (API) Anti-Hypertensive
In-House
specifications
Proposed Pack size As per SRO
The status in reference regulatory Edarbi Tablet (40mg, 80mg) by Arbor
authorities Pharms LLC, USFDA
Approved.
For generic drugs (me-too status) N/A
manufacturer DRAP (AD-1998036-5147) issued on the
basis of inspection conducted on 18/06/2020
Is submitted,
Name and address of API manufacturer. M/s CTX Life Sciences Pvt. Ltd., Block No:
251/P, 252/P, 253 to 255, 256/P, 258/P,
276/P, 277, 278/P, 279 to 282, 283/P, 284/P,
GIDC Sachin, Surat-394 230 Gujarat, India.
submitted.
controls, specifications, impurity testing for
impurity A-G, analytical procedure and its

of drug substance
Real time: 5°C ± 3°C for 72 months
6 months
B: AK180002, AK180003, AK180004
comparative dissolution profile against Edarbi 40mg tablet in 0.1N HCl,
Phosphate Buffer and Acetate Buffer. The
values of F2 are in acceptable range (B:
483822).
against Edarbi 40mg tablet (B: 483822) by
performing all the quality tests.
Manufacturer of API M/s CTX Life Sciences Pvt. Ltd., Block No: 251/P, 252/P, 253 to
255, 256/P, 258/P, 276/P, 277, 278/P, 279 to 282, 283/P, 284/P,
API Lot No. 19AK00013
Description of Pack
(Container closure Aluminium blisters integrated with desiccant.
system)
Real Time: 0, 3, 6, 9, 12 (Months)
Batch No. MAM-001 MAM-002 MAM-001
No. of Batches 03

the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate No. 19061470 valid till
of API manufacturer issued by 01/07/2022 issued by Food & Drugs Control
concerned regulatory authority of Administration.
country of origin. Copy of retention of License to Manufacture
No. G/25/1723 valid till 23/01/2026 is
submitted.
3. Documents for the procurement of API Copy of attested invoice No. EI/3092100609
with approval from DRAP (in case of dated 23/09/2019 (Dy. No. 1572/2020-
import). DRAP dated 27/01/2020) is submitted.

etc.
testing
accelerated)
Remarks of Evaluator-I:
No.
1 Provide the documents (invoice etc) The firm has submitted copy of attested
confirming import of drug substance invoice no. E1/3092100609 dated
for product development. 23/09/2019 dy. No. 1572/2020-DRAP
dated 27/01/2020.
2 Please provide CoA of drug substance COA from drug product manufacturer is
for the batch used for product submitted for the relevant batch that is used
development from the drug product for development of the applied product
manufacturer along with the analytical (B:19AK00013)
procedures used for routine analysis of
drug substance.
3 In section 3.2.P.5.6, please provide Submitted.
justification for the specifications of
the applied product.
4 Provide complete calculations for Factor: 1.067
potency adjustment considering the Assay (Anhydrous): 100.06%
assay value of the drug substance, saltLoss on drying: 0.37%
factor etc. Assay As-is: 99.69%
Batch size: 1500 tab
Quantity to be dispensed: 42.813mg / tab
For 1500 tablets: 64.219g
Decision: Approved. Registration Board further decided that registration letter will be
issued after submission of applicable fee that is Rs. 7,500/-for revision of specifications

and differential fee of Rs. 45,000/- since the applied product is new drug as per
25. Name, address of Applicant / Marketing M/s Horizon Healthcare Pvt., Ltd., Plot # 33,
Authorization Holder Sundar Industrial Estate Lahore.
Name, address of Manufacturing site. M/s Horizon Healthcare Pvt., Ltd., Plot # 33,
Sundar Industrial Estate Lahore.
☐ Importer
giver)
☐ Export sale
Azilsartan Medoxomil 80mg Tablet
name
In-House
specifications
authorities Pharms LLC, USFDA Approved.
For generic drugs (me-too status)
manufacturer DRAP (AD-1998036-5147) issued on the
basis of inspection conducted on 18/06/2020
Is submitted,
Name and address of API manufacturer. M/s CTX Life Sciences Pvt. Ltd., Block No:
251/P, 252/P, 253 to 255, 256/P, 258/P,
276/P, 277, 278/P, 279 to 282, 283/P, 284/P,

submitted.
controls, specifications, impurity testing for
impurity A-G, analytical procedure and its
of drug substance
6 months
B: AK180002, AK180003, AK180004
comparative dissolution profile against Edarbi 80mg tablet in 0.1N HCl,
Phosphate Buffer and Acetate Buffer. The
values of F2 are in acceptable range (B:
483803).
against Edarbi 40mg tablet (B: 483803) by
performing all the quality tests.
Manufacturer of API M/s CTX Life Sciences Pvt. Ltd., Block No: 251/P, 252/P, 253 to
255, 256/P, 258/P, 276/P, 277, 278/P, 279 to 282, 283/P, 284/P,
API Lot No. 19AK00013
Description of Pack Aluminium blisters integrated with desiccant.

(Container closure
system)
Real Time: 0, 3, 6, 9, 12 (Months)
Batch No. HAM-001 HAM-002 HAM-001
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate No. 19061470 valid till
of API manufacturer issued by 01/07/2022 issued by Food & Drugs Control
concerned regulatory authority of Administration.
country of origin. Copy of retention of License to Manufacture
No. G/25/1723 valid till 23/01/2026 is
submitted.
3. Documents for the procurement of API Copy of attested invoice No. EI/3092100609
with approval from DRAP (in case of dated 23/09/2019 (Dy. No. 1572/2020-
import). DRAP dated 27/01/2020) is submitted.

etc.
testing
accelerated)
No.
1 Provide the documents (invoice etc) The firm has submitted copy of attested
confirming import of drug substance invoice no. E1/3092100609 dated
for product development. 23/09/2019 dy. No. 1572/2020-DRAP
dated 27/01/2020.
2 Please provide CoA of drug substance COA from drug product manufacturer is
for the batch used for product submitted for the relevant batch that is used
development from the drug product

manufacturer along with the analytical for development of the applied product
procedures used for routine analysis of (B:19AK00013)
drug substance.
3 In section 3.2.P.5.6, please provide Submitted.
justification for the specifications of
4 Provide complete calculations for Factor: 1.067
potency adjustment considering the Assay (Anhydrous): 100.06%
assay value of the drug substance, saltLoss on drying: 0.37%
factor etc. Assay As-is: 99.69%
Batch size: 1500 tab
Quantity to be dispensed: 85.63mg / tab
For 1500 tablets: 128.438g
26. Name, address of Applicant / Marketing M/s NovaMed Pharmaceuticals (pvt) ltd., 28-
Authorization Holder km, Ferozepur road, Lahore.
Name, address of Manufacturing site. M/s NovaMed Pharmaceuticals (pvt) ltd., 28-
km, Ferozepur road, Lahore.
☐ Importer
giver)
☐ Export sale
Empozin 12.5/850mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin…………….12.5mg
per unit Metformin HCl…………...850mg
Pharmaceutical form of applied drug Film coated tablet
Pharmacotherapeutic Group of (API) Drugs used in diabetics (Combination of oral
blood glucose lowering drugs)
In-House
specifications
Proposed Pack size 10’s, 14’s

The status in reference regulatory Synjardy Tablet (5/850, 5/1000,
authorities 12.5/500, 12.5/850, 12.5/1000), EMA
approved.
For generic drugs (me-too status) Adrance-M Tablet 12.5mg + 850mg by M/s
Atco Laboratories, Reg. No. 095147
GMP status of the Finished product Last inspection report dated 06/08/2021 is
manufacturer submitted.
Name and address of API manufacturer. Empagliflozin:
Jiangsu Yongan Pharmacetuical Co.,
Limited, No. 18 237 provincial road,
economic development zone, Huaian
Jiangsu, China.
Metformin HCl:
Aarti Drugs Limited, Plot No. 211 - 213,
Road No.2 G.I.D.C., Sarigam, 396 155 Dist.:
Valsad, Gujarat, INDIA.
of drug substances and drug product is
submitted.
Module III (Drug Substance) Empagliflozin and Metformin are classified
as BCS class III drugs. The firm as submitted
analytical procedures and its verification /
substances that is Empagliflozin and
Metformin.
Stability studies Empagliflozin:
• 36 months real time stability studies
conducted at 30°C ± 2°C / 65% ±
5%RH of 03 batches.
• 06 months accelerated stability
studies conducted at 40°C ± 2°C /
75% ± 5%RH of 03 batches
Batches: 130701, 13702, 130801
Metformin HCl:

• 60 months real time stability studies
conducted at 30°C ± 2°C / 65% ±
5%RH of 03 batches.
• 06 months accelerated stability
studies conducted at 40°C ± 2°C /
75% ± 5%RH of 03 batches
Batches: MET10040109, MET10040110 &
MET10040111
Pharmaceutical equivalence and Firm has submitted results of pharmaceutical
comparative dissolution profile equivalence by performing all the quality
tests against the reference product Synjardy
12.5/850mg Batch No. 04891.
Comparative dissolution profile is submitted
against the reference product Synjardy
(B:04891) in all the 03 media that is 0.1N
HCl, Acetate Buffer and Phosphate Buffer.
The values of F2 are in the acceptable range.
Manufacturer of API Empagliflozin:

Jiangsu Yongan Pharmacetuical Co., Limited, No. 18 237
provincial road, economic development zone, Huaian Jiangsu,
China.
Metformin HCl:
Aarti Drugs Limited, Plot No. 211 - 213, Road No.2 G.I.D.C.,
Sarigam, 396 155 Dist.: Valsad, Gujarat, INDIA.
API Lot No. 4500-202003001 (Empagliflozin)
MEF/11020379 (Metfromin)
Description of Pack
(Container closure
system)
Batch No. RD/PR21- RD/PR21-
RD/PR21-059/T1/S2
059/T1/S1 059/T1/S3

Batch Size 2000 tab 2000 tab 2000 tab
No. of Batches 03
1. Reference of previous approval of The firm has not submitted any response
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificates;
of API manufacturer issued by Empagliflozin:
concerned regulatory authority of Copy of GMP certificate issued by Huaian
country of origin. Pharmaceutical Industry association is
submitted valid till 14-01/2024.
Metformin HCl:
Copy of GMP certificate No. 6096236 valid
till 01-11-2021 issued by FDA Maharashtra,
India.
3. Documents for the procurement of API Copy of ADC attested invoice No.
with approval from DRAP (in case of ZY20052001G/W dated 20/05/2020 dy. No.
import). 7093/2020-DRAP dated 09/06/2020 is
submitted for Empagliflozin.
Copy of invoice no. EXP/3236/20-21 dated
05/03/2021 dy. No 4485/2021-DRAP dated
26/03/2021 for Metformin is submitted.
etc.
testing
accelerated)
No.
1. Provide GMP certificate / drug Copy of DML no. SU2016324 valid till 06-
manufacturing license of Empagliflozin 12-2025 issued by Jiangsu medical products
drug substance manufacturer issued by administration.
the relevant authority. The submitted
copy of GMP certificate is neither
verifiable nor it is issued by relevant
authority, conversely the submitted
certificate is issued by Industry
Association.
2. Submitted data of analytical method The Firm has provided the details of
validation studies for Empagliflozin specificity testing for analytical method
drug substance does not contain the test validation studies for Empagliflozin drug

for Specificity parameter performed by substance performed by drug product
drug product manufacturer. Please manufacturer.
provide the required data. Moreover,
clarification is required regarding the
criteria / basis of naming the dilutions (as
60%, 80%, 100% 160% etc) for
performing the accuracy and linearity
tests.
3. USP-43 describes the HPLC assay “we have tested Metformin as per USP 42
method for analysis of Metformin HCl where assay is given by titration method.
but you have performed the required Accordingly, we have performed validation
studies for drug substance including of the method”.
analytical method validation / The firm has not performed the analysis as
verification studies using titration per USP 43 (HPLC method) for estimation of
method, please clarify. Metformin.
4. The detail of capsule filling machine is Revised manufacturing process is submitted.
provided in 3.2.P.3 while detail
regarding tablet manufacturing facility is
required.
5. As per submitted dossier, the The firm has provided the manufacturing
manufacturing method is not in detail, it method.
provides a very brief details of different
steps involved in the manufacturing of
the applied product. Please provide
detailed manufacturing method with the
detail of each step including wet
granulation.
6. Justify the dissolution that is 80% in 30 “After reviewing the dissolution release trend
minutes while as per the available in CDP report it is evident that more than
literature the innovator has specified 20 80% drug is released in 20 minutes so we are
minutes for achieving the required revising our current acceptance specification
dissolution limit. limit to NLT 80% in 20 minutes instead of
30minute”.
The firm has submitted the revised
specifications without performing the
dissolution test according to new specs on
any of the batch.
7. Justification regarding the performance “ICH Q2R1, specificity is the ability to assess
of specificity parameter of method unequivocally the analyte in the presence of
validation studies for drug product is components which may be expected to be
required where the test is performed present. Typically these might include
without spiking by taking the blank impurities, degradants, matrix etc”.
solution as reference. “We have rub placebo containing matrix and
there is no interference observed in analytical
method validation of product”.
8. The submitted stability data is till 3rd The firm has submitted stability data till 6th
month time point while the required data month time point.
should be till 6th month time point, please
submit the remaining data.
9. Please provide documents confirming Copy of ADC attested invoice No.
the import of drug substances ZY20052001G/W dated 20/05/2020 dy. No.
(Empagliflozin and Metformin) (e.g. 7093/2020-DRAP dated 09/06/2020 is
invoice) along with the relevant COAs submitted for Empagliflozin.

from drug substance manufacturers as Copy of invoice no. EXP/3236/20-21 dated
well as from the finished product 05/03/2021 dy. No 4485/2021-DRAP dated
manufacturer. 26/03/2021 for Metformin is submitted.
10. Provide detail of container-closure of the Alu-Alu blister, each containing white
applied product since container-closure colored, oval shaped film coated tablets
is described very briefly and little having break line on one side and the other
information is presented in the submitted side is plain.
dossier. 10’s, 20’s, 30’s, 14’s, 28’s.
that registration letter will be issued after submission of applicable fee that is Rs. 7500/-
for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
• For commercial manufacturing, the manufacturer will perform analytical
testing for Metformin as per USP 43.
27. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (pvt) Ltd. plot
Authorization Holder No. 204-205, Industrial Triangle, Kahuta
road, Islamabad.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (pvt) Ltd. plot
No. 204-205, Industrial Triangle, Kahuta
road, Islamabad.
☐ Importer
giver)
☐ Export sale
Myotan 40mg Tablet
name
Active Pharmaceutical ingredient (API) Azilsartan Medoximil as
In-House
specifications

The status in reference regulatory 4 Edarbi Tablet (40mg, 80mg) by
authorities Arbor Pharms LLC,
USFDA Approved.
GMP status of the Finished product GMP certificate No. F.3-16/2018-
manufacturer Addl.Dir.(QA&LT) dated 24/12/2018.
Name and address of API manufacturer. M/s Ami Life Sciences Private limited,
Block No. 82/B, ECP road, At & Post:
Karakhadi-391450, Taluka: Padra, District
Vadodara Gujrrat, India.
submitted.
6 months
B: AZP/50031216, AZP/50041216,
AZP50051216
comparative dissolution profile against Edarbi Tablet 40mg, USFDA
Approved B. No. 11701856, by performing
quality tests.
Comparative Dissolution Testing is
performed against the same brand.

Manufacturer of API M/s Ami Life Sciences Private limited, Block No. 82/B, ECP
road, At & Post: Karakhadi-391450, Taluka: Padra, District
API Lot No. AZP/50180920
Description of Pack
(Container closure Alu-Alu blister in unit carton
system)
Batch No. ST21B043 ST21B044 ST21B045
No. of Batches 03
the firm (if any)
country of origin.
3. Documents for the procurement of API ADC attested invoice No. EXP/20-21/0539
with approval from DRAP (in case of dated 16/01/2021 Dy. No. 405 dated
import). 28/01/2021.

etc.
testing
accelerated)

No.
1 The specifications of Drug Substance “We have just based the particle size
do not include particle size estimation on sieve analysis at vendor
determination test while the innovator sample whose result is attached”.
has performed the said test for drug
substance, please clarify.
2 Since the drug product does not “R&D batches are no true replica of
contain any antimicrobial preservative commercial batches as these batches are not
as well as it does not possess inherent sometime manufactured in strict
anti-microbial activity nor any such environmental conditions, so the microbial
data which supports the microbial testing results of these R&D batches will
inhibitory property of the drug product not be the actual picture of manufacturing
is provided with the submitted dossier, controls conditions that is why we omit this
therefore, as per ICH guidelines test”.
(Q6A) microbial limits’ acceptance “In general practices we are performing the
criteria and testing should have been microbial testing on commercial batches. In
performed. As per available literature this case we will also adopt this practice.
of the innovator’s product (Edarbi
tablet), the manufacturer has
established the microbial limits and
performed the microbial testing on the
commercial batches.
3 In section 3.2.P.5.6, please provide The firm has submitted justification for the
justification for the specifications of specifications in section 3.2.P.5.6.
4 The submitted stability data is till 3rd Submitted.
month time point, please provide 6
month stability data.
5 Provide documents (invoice) for the ADC attested invoice No. EXP/20-21/0539
procurement of API with approval dated 16/01/2021 Dy. No. 405 dated
from DRAP (in case of import). 28/01/2021.
6 Provide GMP certificate of drug Copy of GMP certificate no. 22043267
substance manufacturer is required valid till 17/04/2025 is submitted.
along with the last inspection
report/GMP certificate of finished
7 Record of Digital data logger for Submitted.
accelerated) is required while you
have submitted the compliance
assessment report.

28. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (pvt) Ltd. plot
Authorization Holder No. 204-205, Industrial Triangle, Kahuta
road, Islamabad.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (pvt) Ltd. plot
No. 204-205, Industrial Triangle, Kahuta
road, Islamabad.
☐ Importer
giver)
☐ Export sale
Myotan 80mg Tablet
name
In-House
specifications
authorities Pharms LLC, USFDA Approved.
GMP status of the Finished product GMP certificate No. F.3-16/2018-
manufacturer Addl.Dir.(QA&LT) dated 24/12/2018.
Name and address of API manufacturer. M/s Ami Life Sciences Private limited,
Block No. 82/B, ECP road, At & Post:
Karakhadi-391450, Taluka: Padra, District
Vadodara Gujrrat, India.

submitted.
6 months
B: AZP/50031216, AZP/50041216,
AZP50051216
comparative dissolution profile against Edarbi Tablet 80mg, USFDA
Approved B. No. 483829, by performing
quality tests.
Comparative Dissolution Testing is
performed against the same brand.
Manufacturer of API
API Lot No. AZP/50180920
Description of Pack
(Container closure Alu-Alu blister in unit carton
system)
Batch No. ST21B047 ST21B048 ST21B049

No. of Batches 03
1. Reference of previous approval of No response is submitted
the firm (if any)
country of origin.
3. Documents for the procurement of API ADC attested invoice No. EXP/20-21/0539
with approval from DRAP (in case of dated 16/01/2021 Dy. No. 405 dated
import). 28/01/2021.

etc.
testing
accelerated)
No.
1 The specifications of Drug Substance “We have just based the particle size
do not include particle size estimation on sieve analysis at vendor
determination test while the innovator sample whose result is attached”.
has performed the said test for drug
substance, please clarify.
2 Since the drug product does not “R&D batches are no true replica of
contain any antimicrobial preservative commercial batches as these batches are not
as well as it does not possess inherent sometime manufactured in strict
anti-microbial activity nor any such environmental conditions, so the microbial
data which supports the microbial testing results of these R&D bacthes will
inhibitory property of the drug product not be the actual picture of manufacturing
is provided with the submitted dossier, controla conditions that is why we omit this
therefore, as per ICH guidelines test”.
(Q6A) microbial limits’ acceptance “In general practices we are performing the
criteria and testing should have been microbial testing on commercial batches. In
performed. As per available literature this case we wll alsoadopt this practice.
of the innovator’s product (Edarbi
tablet), the manufacturer has
established the microbial limits and
performed the microbial testing on the
commercial batches.

3 In section 3.2.P.5.6, please provide The firm has submitted justification for the
justification for the specifications of specifications in section 3.2.P.5.6.
4 The submitted stability data is till 3rd Submitted.
month time point, please provide 6
month stability data.
5 Provide documents (invoice) for the ADC attested invoice No. EXP/20-21/0539
procurement of API with approval dated 16/01/2021 Dy. No. 405 dated
from DRAP (in case of import). 28/01/2021.
6 Provide GMP certificate of drug Copy of GMP certificate no. 22043267
substance manufacturer is required valid till 17/04/2025 is submitted.
along with the last inspection
report/GMP certificate of finished
accelerated) is required while you
have submitted the compliance
assessment report.
Case No. II: Import (Human) cases of Form 5F

New Cases:
29. Name, address of Applicant / Importer M/s Pfizer Pakistan Limited, B-2, S.I.T.E
Karachi.
Details of Drug Sale License of importer License No: 030
Address: Pfizer Pakistan Ltd., B-2 SITE
Krachi.
Address of Godown:
12 Dockyard road West Wharf Karachi
C-II-D, SITE Karachi.
Validity: 25-02-2023
Status: Drug License by way of Wholesale
Name and address of marketing M/s Pfizer Europe MA EEIG, Boulevard de la
authorization holder (abroad) Plaine 17, 1050 Bruxelles, Belgium.
Name, address of manufacturer(s) M/s Pfizer manufacturing Deutschland GmbH,
Betriebsstatte Freiburg, Mooswaldalle 1 79090
Frieburg, Germany.
Name of exporting country Germany
Detail of certificates attached (CoPP, Free sale certificate, GMP certificate)
• Firm has submitted original, legalized COPP certificate (No. 05/21/157659) dated
28/05/2021 issued by EMA.
The applied product is available for free sale in the market of exporting region.

The facilities and operations conform to WHO-GMP.
• Embassy attested GMP certificate No. De_BW_01_GMP_2021_006 issued on the
basis of inspection conducted on 07/10/2020.
Details of letter of authorization / sole agency agreement:

• Letter of authorization is submitted whereby the MAH has authorized M/s Pfizer
Pakistan Limited for MAH activities in Pakistan for the applied product.
Status of the applicant ☐ Manufacturer
☒ Importer
giver)
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
☐ Export sale
For imported products, specify one the ☒ Finished Pharmaceutical product import
these ☐ Buk import and local repackaging
☐ Buk import and local repackaging for export
purpose only
The proposed proprietary name / brand Ibrance film coated tablet 75mg
name
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Palbociclib…….75mg
Pharmaceutical form of applied drug Immediate release film coated tablet
Pharmacotherapeutic Group of (API) Anti-neoplastic /Protein kinase Inhibitor
Reference to Finished product Innovator’s specs
specifications
Proposed Pack size Pack of 21 tablets
The status in reference regulatory Ibrance tablet (75mg, 100mg, 125mg), USFDA
and stability studies of drug substance and
product.

Name, address of drug substance M/s Pfizer Ireland Pharmaceuticals,
manufacturer Ringaskiddy API plant Ribgaskiddy County
Cork, Ireland.
Module-III Drug Substance: The drug substance belongs to BCS class II
drugs. Crystalline anhydrous form a is the most
thermodynamically stable form used in the
manufacturing. Firm has submitted detailed
drug substance data for both sources related to
Stability Studies of Drug Substance • Real time stability studies have been
(Conditions & duration of Stability conducted at 25oC±2 and 60%RH±5% for
studies) 36 months of 3 batches
• Accelerated stability study is conducted at
40oC±2 and 75%RH±5% for 6 months of 3
batches
Batches: E010014100, E010014102, GR06107
and stability.
Pharmaceutical Equivalence and N/A
Comparative Dissolution Profile
Analytical method validation/verification Analytical validations studies for drug
of product substance as well as for drug product are
submitted.
Container closure system of the drug Polyvinylchloride / Oriented Polyamide /
product Aluminium foil / Polyvinylchloride
(PVC/OPA/Al/PVC/Al) blister with aluminium
foil lidding card containing 7 tablets. Each pack
contains 3 blisters.
Stability study data of drug product, shelf • Real time stability studies have been
life and storage conditions conducted at 30oC±2 and 75%RH±5% for
24 months of 03 batches
• Accelerated stability studies is conducted
at 40oC±2 and 75%RH±5% for 6 months
of 03 batches

• Batches: H000013329 S83543,
H000013329 S83544, H000013329
S83545
• Shelf life: 2 years
Evaluation by PEC-I:
Indications:
Palbociclib is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic
breast cancer in combination with:
• an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men;
or
• fulvestrant in patients with disease progression following endocrine therapy
No.
1 As per the submitted dossier, the “M/s Pfizer limited, Sandwich, UK is a Pfizer
manufacturer of Drug Substance is M/s R&D site and was sed to manufacture the
Pfizer Ireland Pharmaceuticals while the DSregistration stability batches. An additional
provided stability data is from another Supportive batch was manufactured at Pfizer
manufacturer, please clarify. Inc USA which is another Pfizer R&D site”.
The firm has submitted Stability data of 03
batches manufactured at M/s Pfizer Ireland
Pharmaceuticals with the following details;
• Real time stability studies have been
conducted at 25oC±2 and 60%RH±5% for
36 motnhs of 03 batches
• Accelerated stability studies is conducted at
40oC±2 and 75%RH±5% for 6 months of
03 batches
Batches: J11579, J14939, J14940
2 Provide stability study data (Real Time & • Real time stability studies have been
Accelerated) according to the conditions of conducted at 30oC±2 and 75%RH±5% for
zone IV-A of 03 batches till claimed shelf 24 months of 03 batches
life. • Accelerated stability studies is conducted at
03 batches
Batches: H000013329 S83543, H000013329
S83544, H000013329 S83545
Decision: Approved with innovator’s specifications as per Policy for inspection of
Manufacturer abroad and verification of local storage facility. Registration Board further
decided that registration letter will be issued after submission of applicable fee that is Rs.
7,500/- for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
30. Name, address of Applicant / Importer M/s M/s Pfizer Pakistan Limited, B-2, S.I.T.E
Karachi.
Krachi.
Address of Godown:

Frieburg, Germany.
☒ Importer
giver)
☐ Export sale
purpose only
name
Pharmaceutical form of applied drug Film coated immediate release tablet
Pharmacotherapeutic Group of (API) Anti-neoplastic / Protein kinase Inhibitor
specifications

product.
Cork, Ireland.
batches
Batches: E010014100, E010014102, GR06107
and stability.
submitted.

of 03 batches
• Batches: H000013330 S80563,
H000013330 S80564, H000013330
S80565
Indications:
or
No.
03 batches
Batches: J11579, J14939, J14940
03 batches
Batches: H000013330 S80563, H000013330
S80564, H000013330 S80565
05-2021.
31. Name, address of Applicant / Importer M/s Pfizer Pakistan Limited, B-2, S.I.T.E
Karachi.

Krachi.
Address of Godown:
Frieburg, Germany.
☒ Importer
giver)
☐ Export sale
purpose only
name
Pharmaceutical form of applied drug
Pharmacotherapeutic Group of (API) Anti-neoplastic / Protein kinase Inhibitor
specifications

product.
Cork, Ireland.
batches
Batches: E010014100, E010014102, GR06107
and stability.

submitted.
of 03 batches
• Batches: H000013331 S78147,
H000013331 S78148, H000013331
S78149
Indications:
or
No.
03 batches
Batches: J11579, J14939, J14940
03 batches

Batches: H000013331 S78147, H000013331
S78148, H000013331 S78149
05-2021.
32. Name, address of Applicant / Importer M/s AJ Mirza Pharma (Pvt.) Ltd.,
1st Floor, Shafi Court, Merewether Road, Civil
Lines, Karachi. Pakistan.
Address: 1st Floor, Shafi Court, Civil Lines,
Merewether Road, Karachi, Pakistan.
Address of Godown: 2nd Floor, Shafi Court,
Civil Lines, Merewether Road, Karachi,
Pakistan.
Validity: 22.12.2022.
Status: License to sell drugs as distributor
Renewal: Renewed
Name and address of marketing M/s Cipla Ltd,
authorization holder (abroad) S-103 to S-105 S-107 to S-112, L- 138
L-147, L-147/1 to L-147/3, & L-147/A, & L-
147/A, L-150 Verna Industrial Estate Verna
Goa.
Name, address of manufacturer(s) M/s Cipla Ltd.,S-103 to 105, S-107 to S-112, L-
138, L-147, L-147/1 to L-147/3 & L-147/A, L-
150, Verna Industrial Estate, Verna Goa, India.
Name of exporting country India
Detail of certificates attached (CoPP, Freesale certificate, GMP certificate)
• Firm has submitted original, legalized CoPP certificate (No. 789/MFG/WHO-
GMP/DFDA/2020/143(4) ) valid up to 19-05-2022 issued by Directorate of Food &
Drug Administration, India the Applied product is available for free sale in exporting
country. The facilities and operations conform to WHO-GMP.
Details of letter of authorization / sole agency agreement
• Copy of Letter of Authorization is attached. M/s Cipla Ltd. Cipla house, Peninsula
Business Park, Gantaptrao Kadam Marg, Lower Parel, Mumbai India authorizes M/s
A.J. Miza Pharma (Pvt) Ltd., 1st Floor Shafi Court, Merewether Road, Civil Lines
Karachi to register, Import & Distribute Erlotinib 25mg Tablets. The authorization
letter is valid till 22-02-2022.
☒ Importer
giver)
☐ Export sale
these

☐ Buk import and local repackaging
purpose only
Dy. No. and date of submission Dy. No. NA : NA
Details of fee submitted PKR 100,000/-: 13-08-2018
The proposed proprietary name / brand Erlocip 25mg Tablet
name
Strength / concentration of drug of Each film coated tablet contains:-
Active Pharmaceutical ingredient (API) Erlotinib HCl eq. to Erlotinib ………..25mg
per unit
Pharmaceutical form of applied drug Tablets
Pharmacotherapeutic Group of (API) Anti-cancer
Reference to Finished product In house
specifications
Proposed Pack size 10 Tablets in a blister Pack, 10/30 Tablets in a
container pack
Proposed unit price As Per SRO
The status in reference regulatory Tarceva 25mg Tablet (USFDA Approved).
authorities
For generic drugs (me-too status) Tarceva 25mg Tablet of Roche Pakistan Ltd.
(Reg # 043001)
Module-II (Quality Overall Summary) Submitted
Name, address of drug substance M/s Cipla Ltd.,S-103 to 105, S-107 to S-112, L-
manufacturer 138, L-147, L-147/1 to L-147/3 & L-147/A, L-
150, Verna Industrial Estate, Verna Goa, India.
Module-III Drug Substance: Firm has submitted detailed drug substance data
for both sources related to nomenclature,
substance.
(Conditions & duration of Stability batches of API at accelerated as well as real time
studies) conditions. The real time stability data is
conducted at 30oC ± 2oC. The stability study data
is till 24 months.
justification of specifications, reference standard

or materials, container closure system and
stability.
Pharmaceutical Equivalence and The firm has submitted pharmaceutical
Comparative Dissolution Profile equivalence performed against Tarceva 25mg
tablet approved by USFDA by performing
quality tests and comparative dissolution profile
in all the 3 media (B:M0004B05) with values of
F2 factor in acceptable range.
Analytical method validation/verification Firm has submitted analytical method validation
of product studies for the applied product.
Container closure system of the drug Alu-lidding foil and clear pvc at one side.
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3
life and storage conditions batches The accelerated stability study data is
conducted at 40oC ±2oC / 75% ± 5% RH for 6
months. The real time stability study data is
conducted at 30oC ±2oC / 75% ± 5% RH. The
real time stability study data of 3 batches is for
24 months.
Evaluation by PEC:
no.
1 Data of product development including The firm has submitted the detail of product
manufacturing process development and development and presented the relevant data
Drug Product specifications data in the in section 3.2.P.2.1 to 3.2.P.6 in detail along
light of decision of Registration Board in with the detail of finished drug specifications,
the light of the decision of 267th meeting. testing method and justification of
specifications in relevant sections along with
the method validation studies for all the
parameters.
3 Submission of product specific letter of Copy of letter of authorization is submitted
authorization. whereby M/s Cipla Limited has authorized AJ
4 Original legalized and valid CoPP Firm has submitted original, legalized CoPP
mentioning the free sale status of the certificate (No. 789/MFG/WHO-
applied product. GMP/DFDA/2020/143(4) ) valid up to 19-05-
2022 issued by Directorate of Food & Drug
Administration, India the Applied product is
available for free sale in exporting country.
The facilities and operations conform to
WHO-GMP.
5 Stability studies according to zone IV-A • Real time stability studies for 03 batches
till shelf life. till 24 months at 30oC ±2oC / 75% ± 5%
RH
• Accelerated stability data of 03 batches till
6 months time point at 40oC ±2oC / 75% ±
5% RH
B: GJ60992, GJ60993, GJ70116

6 Detail of pack size is required. 10 tablets in a blister, 10/30 tablets in a
container pack.

05-2021.
Deferred cases:
33. Name, address of Applicant / Importer M/s AJM Pharma (Pvt) Ltd.
1st Floor, Shafi Court, Civil Lines Merewether
Road, , Karachi.
Address of the godown:
Address1:
Ground floor, Plot no. 44 Sector 27, Korangi
Industrial Area, Karachi
Address2:
Shed No. F-9, PI.No.S1, Survey No.230 Sector –
02, Road 4000, Korangi Industrial area, Karachi.
Details of Drug Sale License of Address: 1st Floor Shafi Court Civil Lines,
importer Merewether Road, Karachi
Status: Drug license by the way of wholesale
Name and address of marketing M/s Jiangsu Hengrui Medicine Co. Ltd. 38
authorization holder (abroad) Huanghe Road, economic and technological
development zone, Lianyungang, Jiangsu 222047,
P.R.China
Name, address of manufacturer(s) M/s Jiangsu Hengrui Medicine Co. Ltd. 38
Huanghe Road, economic and technological
P.R.China.

Name of exporting country CHINA
Detail of certificates attached (CoPP, CoPP: Firm has submitted Original Valid CoPP
Free sale certificate, GMP certificate) (Certificate#MTMU-9M53) issued by United
States Food And Drug Administration for
Carmustine 100mg For Injection. The CoPP
confirms free sale status of the product in the
exporting country as well as GMP status of the
manufacturing site through periodic inspection
once in a year.
The certificate is valid till 08.09.2023.
Copy of GMP certificate No : JS20180922 Valid
till 18-10-2023 is submitted issued by China food
and drug Adminstration
Details of letter of authorization / sole Firm has submitted a copy of letter of authorization
agency agreement M/s Jiangsu Hengrui Medicine Co. Ltd. 38
Huanghe Road, economic and technological
P.R. China. According to the letter, the firm
authorizes M/s AJM Pharma (Pvt) Ltd. with
registered address at 1st floor, Shafi Court,
Merewether Road, Civil Lines, Karachi -75520,
Pakistan to apply for registration of applied
product manufactured by M/s Jiangsu Hengrui
Medicine Co. Ltd. for importation and distribution
in the territory of Pakistan.
The letter was issued on 04-07-2019 and it is valid
for five years from date of issue.
☒ Importer
Intended use of pharmaceutical ☒ Domestic sale
For imported products, specify one ☒ Finished Pharmaceutical product import
the these ☐ Buk import and local repackaging
purpose only
Dy. No. and date of submission Dy.No. 15879 dated 27-08-2019
The proposed proprietary name / Carmus 100mg/Vial For Injection
brand name
Strength / concentration of drug of Each Vial contains:
Active Pharmaceutical ingredient Carmustine…..100 mg
(API) per unit
Pharmaceutical form of applied drug Sterile lyophilized pale-yellow granule or
congealed mass for
intravenous infusion after reconstitution

Pharmacotherapeutic Group of (API) Alkylating antineoplastic agent
specifications
Proposed Pack size 1 Vial with 1 Vial of Sterile Diluent 3 mL of
Dehydrated Alcohol Injection
Proposed unit price As per PRC
The status in reference regulatory BiCNU (carmustine for
authorities injection) under NDA 017422 held by Emcure
Pharmaceuticals Ltd. Was approved by FDA
For generic drugs (me-too status) NA
impurities, specifications, analytical procedures
and its validation, batch analysis and justification
substance.
The firm has summarized information of drug
product including its description, composition,
process validation protocols, control of excipients,
control of drug product, specifications, analytical
procedures, validation of analytical procedures,
batch analysis, justification of specifications,
reference standard or materials, container closure
system and stability.
Name, address of drug substance Jiangsu Hengrui Medicine Co., Ltd.
manufacturer 22 Jinqiao Road, Dapu Industrial Park
Lianyungang, Jiangsu 222002, China
Contact: Lin Li, Ph.D.
manufacturers, Characterization, specifications,
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches
(Conditions & duration of Stability of API at accelerated and real time conditions. The
studies) real time stability data were conducted at 5±3oC
for 36 months and accelerated stability data were
conducted at 25°C ± 2°C, RH: 60% ± 5% for 2
months
development, manufacture, description of

manufacturing process and process control, process
validation report, control of excipients, control of
drug product, specifications, analytical procedures,
Pharmaceutical Equivalence and Pharmaceutical equivalence is established against
Comparative Dissolution Profile Carmustine for injection Batch No# CDAA608
BiCNU (Carmustine for
injection) under NDA 017422 held by Emcure
Pharmaceuticals Ltd. Was approved by FDA.
Analytical method The firm has submitted validation results of assay
validation/verification of product method, related substances, of Carmus Injection
100mg.
Container closure system of the drug Glass Vial: 30 mL vial made of neutral
product borosilicate glass tubing, Type I clear, amber and
siliconized glass.
Stopper: 20 mm rubber stopper for lyophilization,

V9154/FM257
Aluminum Flip-off Seal: 20 mm*7.2 mm, blue
flip-off seals without logo
Stability study data of drug product, Firm has submitted stability study data of 3
shelf life and storage conditions batches with upright and inverted orientation:
Batch No. Batch Size Mfg. Date
170803AB 4254 Vials 24-08-2017
170830AB 4557 Vials 21-09-2017
170909AB 4522 Vials 21-09-2017
The firm has performed Real time stability study

at 2oC – 8 oC for 18 months and accelerated
stability study at 25 oC±2 oC/60%±5%RH for 06
months.
In-use stability study at 2oC – 8 oC for 24hours
Evaluation by PEC:
1.3.3. Importer shall provide Certificate Not submitted.
of Pharmaceutical Product
(CoPP) / Free Sale certificate
issued by relevant regulatory
authority in the country of origin
and name of exporting country.
1.4.1. Generic Drug Product (GDP Firm submitted fee of Rs: 50000/-
mentioned while fee of Rs: deposit slip No:72513093 , Dated:12-
50000/- submitted. 11-2021
3.2.S.7 Submit Stability Studies data of In Drug substance accelerated stability
Drug Substance. studies terminated after 2months due to
the result of 2-chloroethanol was out of
specification for two of three batches,
3.2.P.2 Pharmaceutical equivalence of the Details of RLD including brand name,
P.2.2.1 applied drug shall be established manufacturer etc. not submitted

with the innovator / reference /
comparator product and results of
all the quality tests (mentioned in
any official pharmacopoeia or
section 3.2.P.5.1 of this
application) of the developed
formulation and the innovator /
reference / comparator product
shall be submitted and discussed
2nd letter 26th November, 2021
1.3.3. Importer shall provide Certificate COPP from United states submitted
of Pharmaceutical Product
(CoPP) / Free Sale certificate
authority in the country of origin
and name of exporting country.
3.2.S.7 In Drug substance if accelerated According to IC Q1A 2.1.7.2. Drug

stability studies terminated after substances intended for storage in a
2months due to the result of 2- refrigerator:
chloroethanol was out of “If significant change occurs between 3
specification for two of three and 6 months’ testing at the accelerated
batches, then how finished storage condition, the proposed re-test
product was manufactured. 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.”
More over the short term Excursion
stability data for drug substance could
address the effect of short term
excursion outside the label storage
condition (between 2oC –and 8 oC)
during the finished product was
manufactured.
The short term excursion stability study
was conducted at 25°C ± 2°C/60% RH
± 5% RH for three batches of drug
substance, and the testing results

obtained up to 30 days for drug
substance meet the acceptance criteria
in the specification and show no
significant changes during the storage,
which could support short term
excursion during shipping or handling
3.2.P.2 Submit details of RLD including BiCNU (carmustine for

P.2.2.1 brand name, manufacturer etc. injection) under NDA 017422 held by
Emcure Pharmaceuticals Ltd. Was
approved by FDA
Decision of 316th meeting: Deferred for following:
• Justification regarding submitted COPP, since country of origin of applied product is China,
whereas submitted COPP has been issued by the United States Food And Drug Administration.
• Scientific rationale for formulating drug product with a drug substance having accelerated
stability studies of only two months.
The firm has stated that:
1. The applied product is approved by USFDA and marketed in USA, therefore, the CoPP issued
by USFDA is submitted along with the dossier. Moreover, due to commercial reasons the applied
product is not marketed in china.
2.
• The limit for 2-chloroethylamine (Impurity) is included in the release and stability
specifications of the finished product and could confirm that the results of the content of the
impurity is within the specified limit.
• Moreover, As per ICH Q1A2.1.7.2. the drug substance intended for storage in refrigerator, if
significant change occurs within first 3 months then a discussion should be provided to address
the effect of short term excursions outside the labelled storage conditions 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 less than 3 months with more frequent testing than
usual. It is unnecessary to continue to test a drug substance through 6 months when a significant
change occurs.
“Significant change for a drug substance is defined as failure to meet it specification”. (2.1.7)
• The short term excursion stability data for drug substance could address the affect of short term
excursions outside the label storage condition during finished product manufacturing.
• The short term excursion stability data is provided in 3.2.S.7.3 in DMF, which could support
short term excursion during shipping. The temperature of the drug substance is controlled
between 2-8oC during the transportation to the finished product manufacturing site. During the
manufacturing of finished product, the temperature is the controlled parameter during
compounding, lyophilization and complete stoppering as well as the holding periods are also
controlled as the critical parameters.
Indications:
Carmstine is a nitrosourea indicated as palliative therapy as a single agent or in established
combination therapy with other approved chemotherapeutic agents in the following:
• Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and
metastatic brain tumors
• Multiple myeloma-in combination with prednisone
• Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs
• Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs
05-2021.

34. Name, address of Applicant / M/s GHAZALI BROTHERS
Importer 19-SR-7, Campbel Street, Azzainab Court, 1st Floor,
Karachi- Pakistan
Details of Drug Sale License of License No: 050
importer Address: 19-SR-7, Campbel Street, Azzainab Court,
1st Floor, Karachi- Pakistan
Validity: 27th Oct 2021
Status: Drug License by the way of Wholesale
Name and address of marketing M/s Shandong luoxin pharmaceutical group stock co.,
authorization holder (abroad) ltd, Luoqi road, linyi high and new technology
industries Development zone shandong province, pr
China.
Name, address of manufacturer(s) M/s Shandong luoxin pharmaceutical group stock co.,
ltd, Luoqi road, linyi high and new technology
industries Development zone shandong province, PR
China.
Name of exporting country China
• The firm has submitted Original legalized CoPP (certificate No. Shandong20200016(5)
for Calcium Folinate for Injection 100mg issued by Shandong Drug Administration valid
till 31/12/2020.
The applied product is available for free sale in exporting country.
• CCPIT legalized barcode: 201100B0/040270 Dated: 02/July/2020
• Drug manufacturing license No. Lu20160194 valid till 31/12/2020.
• Copy of GMP certificate No. SD20191020 valid till 10/12/2024.
• Firm has submitted Exclusive Distribution Agreement wherein M/s SHANDONG
LUOXIN PHARMACEUTICAL GROUP STOCK CO. LTD Luoqi Road, Linyi
National High and New Technology Industries Development Zone, Shandong Province,
PR China authorized M/s GHAZALI BROTHERS 19-SR-7, Campbel Street, Azzainab
Court, 1st Floor, Karachi- Pakistan for marketing and selling for Calcium folinate
injection 100mg..
☒ Importer
giver)
☐ Export sale
these ☐ Bulk import and local repackaging
☐ Bulk import and local repackaging for export
purpose only
Dy. No. and date of submission Dy. No. 7594 : 05-08-2020
Details of fee submitted PKR 100,000/- : 05-08-2020

The proposed proprietary name / brand CALFOLINATE for Injection 100mg
name
Strength / concentration of drug of Active Each vial contains :
Pharmaceutical ingredient (API) per unit Folinic Acid as calcium folinate
pentahydrate.......100mg
Pharmaceutical form of applied drug Off-white to yellow loose cake or powder
(lyophilized) for solution for IV/IM injection
Pharmacotherapeutic Group of (API) Detoxifying agents for antineoplastic treatment
Reference to Finished product Chinese Pharmacopeia
specifications
Proposed unit price As per DRAP’s pricing policy
The status in reference regulatory Leucovorin Calcium 100mg base/vial by M/s
authorities Teva Pharms USA, USFDA Approved.
For generic drugs (me-too status) CALFONATE INJECTION 100MG by M/s
GHAZALI BROTHERS, Reg. No. 70936
properties, solubility, physical form,
stability studies of drug substance and Drug
Product.
Name, address of drug substance M/s Zhejiang Davi Pharmaceutical Co., Ltd.
manufacturer No.818 Xinzhu Road, Economic Development
Area, Huzhou City, Zhejiang Province 313000,
The People’s Republic of China
structure, general properties, solubility, physical
form, manufacturers, description of
substance.
(Conditions & duration of Stability conducted at 25oC±2 and 60%RH±5% for 24
studies) months of 3 batches
batches
Batches: CAN161201, CAN161202,
CAN161203

development, manufacture, manufacturing
process and process control, process validation
protocols, control of excipients, control of drug
product, specifications, analytical procedures,
analysis, justification of specifications, reference
and stability.
Pharmaceutical Equivalence and Not submitted.
Analytical method Firm has submitted analytical method validation
validation/verification of product studies for the applied product.
Container closure system of the drug Injection vials made of low borosilicate glass
product tubing, bromobutyl rubber stopper for sterile
powder for injection and aluminum-plastics
combination caps for injection vials
life and storage conditions conducted at 25oC±2 and 60%RH±5% for 36
months of 3 batches
batches
Batches: 514082033, 514082043, 514082053
Evaluation by PEC:
Calcium folinate equivalent to Folinic acid Shandong Luoxin Response: We apologize for
100mg is the actual quantity of base used in the mistakes of the names shown in batch
the formulation while in section 2.3.P.3.2 formula. The mistakes have been rectified
under batch formula, Calcium Folinate following your comments, please find the revised
(calculates as folic acid) and in section Section 2.3.P.3.2 and 3.2.P.3.2 in Attachment 1
3.2.P.3.2 under Batch Formula is written. and 2. The name claimed in the label and carton
Since Folic Acid and Folinic Acid are two is also revised following your comments.
different chemical compounds therefore you The firm has submitted relevant sections with
are required to rectify the mistake and submit correct label claims and batch formulas.
the information under relevant sections.
The submitted real time stability studies for The firm has submitted stability data of 03
drug product are conducted at 25oC±2 and batches with the following details;
60%RH±5% while real time stability studies • Real time stability studies have been
of 03 batches till claimed shelf life according conducted at 30oC±2 and 65%RH±5% for
to the conditions of Zone IV-A (30oC±2 and 24 months of 3 batches
65%RH±5%) are required. • Accelerated stability study is conducted at
batches
Batches: 518042042, 518102041, 518102042
Pharmaceutical equivalence of the applied Pharmaceutical equivalence is submitted against
product should be established by performing Leucovorin Calcium by M/s Westward-Hikma,
all the quality tests against the innovator’s USA by performing all the quality tests. (Batch:
product and should be presented in the 1909A01).
relevant sections.
The official monograph for C (Leucovorin The firm has submitted a comparison of
Calcium) is present in USP while the testing specifications of Chinese Pharmacopoeia and
of the applied product is done according to In-

House standard/Chinese Pharmacopoeia, USP. Limits are same in both monographs but the
please justify scientifically by comparing the method used are different.
specifications & methods described in USP USP describes the tests of 7 impurities for
with the methods & specifications of In- separately while Chinese pharmacopoeia does
House standard since the methods of analyses not describe individual impurities but it gives
used are different. total impurity limit NMT 2.5% which is similar
to USP. Moreover, the limit for unspecified
impurity in USP is 0.5% while according to C.P.
is 1%.
The test for specificity parameter of “The difference of excipient and brand of
validation/verification of analytical method is reagents used in the testing were taken into
performed by performing the tests on the account during the verification of analytical
sample solution against placebo solution, procedure, the specificity was verified by
please refer the guideline for the procedure comparing the interference on the sample
adopted while the specificity test is solution against placebo”.
performed by spiking with appropriate level
of impurities or exposing the drug product
sample to relevant stress conditions as
recommended by USP.
• Decision of 313rd meeting: The Board deferred the case for;
• Submission of impurity profiling according to USP for the applied product.
• Submission of Drug-excipient compatibility studies.
• Confirmation of the area where the applied product would be manufactured.
• Firm’s response: Firm has submitted following:
• The firm has submitted revised specifications for the applied product according to USP and
submitted comparison of specifications of USP and In-house specs. Moreover, the firm has
submitted COAs of 03 batches which have been tested against USP specification along with
the results of tests of all the impurities. The results of impurities are in the limits as specified
by USP.
Batches: CAN200105, CAN200102, CAN200101
• The applicant has submitted drug-excipient compatibility studies. The tests have been
performed by preparing binary and tertiary solutions and placing the solution under different
conditions including high temperature that is 60oC/high humidity strong light irradiation etc
for 10 days.
• Firm has submitted copy of GMP certificate (Certificate no. SD20191021) valid till 10-12-
2024, issued by Shandong Food & Drug Administration in name of M/s Shandong Luoxin
Pharmaceutical Group Stock Co., Ltd., wherein Scope of inspection has been declared as
“Lyophilized Powder for injection.”
• Decision: Approved with USP specifications as per Policy for inspection of Manufacturer
abroad and verification of local storage facility. Registration Board further decided that
registration letter will be issued after submission of applicable fee that is 7,500/- for revision
of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
35. Name, address of Applicant / M/s Adcare Pharma, House No. D-145, 5th road,
Importer Satelite town Rawalpindi.
Details of Drug Sale License of License No: 01-374-0177-028459D
importer Address: Adcare Pharma, House No. D-145, 5th road,
Satelite town Rawalpindi.
Godown: House No. D-145, 5th road, satellite town,
Rawalpindi.
Validity: 24/03/2022

Name and address of marketing M/s Lunan Better Pharamceutical Co., Ltd., No. 243,
authorization holder (abroad) Yingueshan road, Linyi city, Shandong province,
China.
Name, address of manufacturer(s) M/s Lunan Better Pharamceutical Co., Ltd., No. 243,
Yingueshan road, Linyi city, Shandong province,
China.
• Original legalized GMP certificate (NO. SD20180814) is submitted with validity of
25/11/2023.
• Original legalized CoPP (certificate No. 20200106) issued by Shandong Food and Drug
Administration, China on 11/12/2020.
The product is not available for free sale in the exporting country.
The facilities and operation conform to WHO-GMP.
• Copy of letter of authorization is submitted
☒ Importer
purpose only
Dy. No. and date of submission Dy. No.31904 : 01/12/2020
Details of fee submitted PKR 100,000/- : 01/12/2020
The proposed proprietary name / Sevocare 250mL for Inhalation
brand name
Strength / concentration of drug of Each 250mL bottle contains:
Active Pharmaceutical ingredient Sevoflurane……..100% (250mL)
(API) per unit
Pharmaceutical form of applied drug Liquid for inhalation.
Pharmacotherapeutic Group of (API) General Anesthetics
Reference to Finished product In-House
specifications
Proposed Pack size 250mL
Proposed unit price Rs. 19980/- per 250mL
The status in reference regulatory Sevoflurane 100% Inhalation Vapour, liquid (250mL
authorities type III amber colored glass bottle), MHRA
Approved.
For generic drugs (me-too status) Sevorance Volatile Liquid For Inhalation by M/s
Abbot, Reg. No. 27374

Summary) template. Firm has summarized information related
its validation, detail of impurities and validations
product.
Name, address of drug substance M/s Shandong New Time Pharmaceutical Co., Ltd.,
manufacturer No. 1 North Outer Ring road, Feixian County,
Shandong 273400, China.
Module-III Drug Substance: Firm has submitted detailed drug substance data for
both sources related to nomenclature, structure,
general properties, solubilities, physical form,
manufacturers, description of manufacturing process
and controls, impurities, specifications, analytical
substance.
Stability Studies of Drug Substance • Real time stability studies have been conducted
(Conditions & duration of Stability at 25oC±2 and 60%RH±5% for 36 months of 3
studies) batches
batches
Batches: (100100, 1001002, 1001003)
description, composition, pharmaceutical
development, compatibility studies of excipients with
drug substance manufacture, manufacturing process
specifications, analytical procedures for the product
along with the impurities, validation of analytical
procedures, detail of impurities and the validation
studies, batch analysis, justification of specifications,
Pharmaceutical Equivalence and
validation/verification of product verification studies including specificity, linearity
and accuracy for drug product, drug substance and
impurities as well.
Container closure system of the drug 250mL amber colored type III glass bottle sealed by
product an aluminium screw cap with a low density
polyethylene liner.

Stability study data of drug product, • Real time stability studies have been conducted
shelf life and storage conditions at 30oC±2 and65%RH±5% for 36 months of 3
batches
batches
Batches: (090301, 090302, 090303)
Evaluation by PEC:
• The applicant holds the registration of “Isofurane Inhalant” 100ml bottle with registration
no. 045727 from the same manufacturer that is M/s Lunan Better Pharmaceutical Co., Ltd.,
China.
• As per the submitted CoPP the applied product is not available for free sale in the exporting
country.
Submission of valid copy of drug sale license The firm has submitted valid copy of DSL with the
is required. following details.
License No: 01-374-0177-028459D
Address: Adcare Pharma, House No. D-145, 5th road,
Satelite town Rawalpindi.
Godown: House No. D-145, 5th road, satellite town,
Rawalpindi.
Submit filled, signed and stamped Form 5F The firm has submitted form 5F with the relevant
with the relevant details which should be documents.
provided along with., since the submitted
Form 5F does not contain any information
regarding the registration application.
Product specific sole agency agreement
between the product license holder and the
applicant is required.
Since you are already granted the registration The firm has stated that they have been granted the
for Isoflurane 100ml bottle, therefore the registration of 100mL sevoflurane and now they are
application for 250ml bottle shall be applying for 250mL. The firm has submitted relevant
submitted, please submit revised form 5F documents for 250mL sevoflurane.
along with the applicable fee.
The submitted data is for 100mL bottle while Submitted.
the registration for 100mL bottle is already
granted by the Board. Therefore, you are
required to provide the relevant data.
Provide evidence of approval of the applied Sevoflurane 100% Inhalation Vapour, liquid (250mL
formulation by reference regulatory type III amber colored glass bottle), MHRA
authorities (with same filled Approved.
volume/strength) which were adopted by
Registration Board in its 275th meeting.
Pharmaceutical equivalence data is not
submitted.
Decision of 316the meeting:
• Submission of Free sale certificate in the country of origin i.e., China for the applied
product in fill volume of 250ml, issued by relevant regulatory authority or else Free sale
certificate in any of the reference regulatory authorities of the applied product from the

same finished drug product manufacturer i.e., M/s Lunan Better Pharamceutical Co., Ltd.,
No. 243, Yingueshan road, Linyi city, Shandong province, China.
• Submission of Pharmaceutical equivalence studies against the innovator product.
• Initially the firm had applied for two filled volumes of Sevoflurane for Inhalation that is
100mL and 250mL and submitted relevant data. Upon communication the firm requested
to consider 250mL bottle for registration against the submitted application. 250mL was not
available for free sale in china as per submitted CoPP. The firm then requested to
considered 100mL glass bottle.
• The case was deferred in 316th meeting for submission of free sale certificate/CoPP and
pharmaceutical equivalence.
• The firm has now submitted original, legalized and valid CoPP for 100mL filled volume
with the following detail;
Certificate No.; Shandong20200105(5)
Free Sale: YES
Facilities and operations conform to WHO-GMP
Manufacturer / Product License Holder: M/s Lunan Better Pharmaceutical Co. Ltd., No.
243 Yiqueshan road, Linyi city, Shandong province, China.
• Pharmaceutical equivalence is established against Ultane (B:1114338) approved by
USFDA by performing all the quality tests.
• Pack size and Price: 1’s & 9600/-.
decided that the applicant will submit full fee that is Rs. 150,000/- before issuance of
registration letter for change of filled volume.
36. Name, address of Applicant / Importer M/s AMGOMED
Office # 4, First Floor Ghausia Plaza, Jinnah
Avenue Blue area Islamabad Pakistan
Details of Drug Sale License of importer License No: DSL-002-ICT/2013
Address: Amgomed office # 4, First floor
Ghausia Plaza, Jinnah Avenue Blue area
Islamabad
Address of Godown: Office number 5, First floor
Rose-I plaza, I-8, Markaz Islamabad.
Name and address of marketing M/s DEVA Holding A.S., Halkali Merkez Mah.
authorization holder (abroad) Basin Ekspres Cad. No:1 34303 Kucukcekmece
– Istanbul/Turkey.
Name, address of manufacturer(s) M/s DEVA Holding A.S.
Çerkezköy Organize Sanayi Bölgesi, Karaagaç
Mah. Fatih Bulvarı No: 26, Kapaklı -
TEKIRDAG/TURKEY.
Name of exporting country Turkey
• Copy of GMP certificate No.TR/GMP/2019/31 dated 28/01/2019 issued by Turkish
Medicines and Medical Devices Agency. (Dosage form: SVP / Special requirements:
Anticancer (oncologic) liquid injectable vials / Activities: manufacturing at sterile liquid
oncologic (anticancer) manufacturing site).
• Firm has submitted original, legalized COPP certificate (No. 2020/1390) dated 22-05-
2020 issued by Republic of TURKEY MEDICINE AND MEDICAL DIVICES
AGENCY For Carbodex 150mg/15mL solution for IV infusion.

The applied product is available for free sale in the market of exporting country.
The COPP is valid till 03-06-2022.

• Copy of letter of authorization is submitted whereby M/s DEVA Holding A.S., Turkey
authorized M/s AMgomed to apply for registration, for marketing, distribution and sale
of below mentioned product;
Carbodex 150mg/15ml solution fir IV injection.
The authorization letter is valid till 15-06-2022.

☒ Importer
giver)
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No.17502 : 23/06/2021
The proposed proprietary name / brand Carbodex 150mg/15ml Solution for IV Infusion
name
Strength / concentration of drug of Active Each ml contains:
Pharmaceutical ingredient (API) per unit Carboplatin……10mg
Pharmaceutical form of applied drug Solution for IV infusion
Pharmacotherapeutic Group of (API) Antineoplastic agent
Reference to Finished product Present in BP (in-house applied)
specifications
The status in reference regulatory Carboplatin 150mg/15ml, concentrate for
authorities solution for infusion by M/s Accord Healthcare
Limited, MHRA Approved.
For generic drugs (me-too status) Carboplat 150mg/15ml solution for injection by
M/s Rotex Pharma pvt ltd.

stability studies of drug substance and product.
Name, address of drug substance Manufacturer:
manufacturer M/s Sicor De Mexico S.A de C.V Av. San
Rafael No. 35 Parque Industrial Lerma, Edo.
De Mexico C.P 52000, Mexico.
DMF Holder:
Teva Pharmaceutical Industries Ltd. 5 /Basel
Street, P.O. Box 3190 Petah Tiqva 4951033,
Israel.
substance.
batches
Batches: (03CBP02A-0CH, 97CBP01A-OC,
97CBP02A-OC)
stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence is established
Comparative Dissolution Profile against DBL Carboplatin 150mg/15ml by M/s
Hospira by performing
Analytical method validation/verification Not submitted.
of product
Container closure system of the drug Amber colored type I glass ampoule
product
life and storage conditions conducted at 30oC±2 and65%RH±5% for

batches
Batches: (A035176, A035177, A035178)
Official monograph for Carboplatin drug No response is submitted against this
substance is present in USP/BP while the testing observation.
is done according to in-house standard, please
clarify.
Analytical method verification studies performed Analytical verification studies performed by
by drug product manufacturer for drug substance drug product manufacturer are submitted
along with the complete method for routine according to In-House specifications.
analysis is required.
Stability study data including accelerated and real No response is submitted against this
time for 03 batches is required till shelf life/retest observations.
period for the drug substance should be
submitted.
Since the official monograph for Carboplatin The has not provided a comparison of In-House
injection is present in B.P while the applied and B.P specifications and no clarification is
product is developed according to In-House submitted as well regarding the In-House
standards. Provide scientific justification and specifications.
comparison of BP and In-House specifications or
provide complete analysis of all parameters for
applied product as described in B.P along with the
submission analytical method verification studies
including accuracy, specificity and precision.
Decision: The Board deferred the case for submission of;
• Clarification since the official monograph of the Carboplatin drug substance present
in USP/BP while the testing is done according to in-house standard
• Submission of Stability study data including accelerated and real time for 03 batches
is required till shelf life/retest period for the drug substance.
• Since the official monograph for Carboplatin injection is present in B.P while the
applied product is developed according to In-House standards. Provide scientific
justification and comparison of BP and In-House specifications or provide complete
analysis of all parameters for applied product as described in B.P along with the
submission analytical method verification studies including accuracy, specificity and
precision.
37. Name, address of Applicant / Importer M/s Organ Pharma office no. 2, Second floor, Plot
# 50-D Khayaban-e-Ittehad, DHA Phase 6,
Karachi Pakistan
importer Address: Organs Pharma, plot No. V-98, first
floor, 6FKorangi Mehran town, I.A.K Kyc,
Karachi.
Name and address of marketing M/s Adamed Pharma S.A. Pienkow ul. Mariana
authorization holder (abroad) Adamkiewicza 6A 05-152 Czosnow Poland
Name, address of manufacturer(s) M/s Adamed Pharma S.A., Ul. Marszalka Jozefa
Pilsudskiego 5 95-200 Pabianice Poland

Name of exporting country Poland
• Original legalized CoPP (certificate number 692/20) certified by Chief pharmaceutical
Inspector, 12 Senatorska street, 00-082 Warsaw, Poland on 10/08/2020. The product is
present in the market of exporting country for free sale. The facilities and operations
conform to WHO-GMP.
• Notarized supply and distribution agreement is submitted whereby M/s Adamed
Pharma S.A. authorized M/s Organs Life Science FZC, Sharjah UAE for the applied
product (100mg and 200mg).
• Another notarized letter of authorization is submitted by the firm whereby M/s
Organs life sciences, Sharjah, UAE authorized M/s Organs Pharma, Karachi
Pakistan for distribution, registration, promotion, import etc for the applied product.
• Legalized CEP certificate for API is submitted.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No 21789 Dated 24-10-2019
Details of fee submitted Rs. 100,000/- dated 21-08-2019
The proposed proprietary name / LUTEINA 100mg vaginal tablet
brand name
Strength / concentration of drug of Each vaginal tablet contains:
Active Pharmaceutical ingredient Progesterone…..100mg
(API) per unit
Pharmaceutical form of applied drug Round, biconvex, white to off-white in colour,
Vaginal Tablet
Pharmacotherapeutic Group of (API) Hormone
Reference to Finished product In-house
specifications
Proposed Pack size 30 tablets per pack
Proposed unit price Rs. 1536/- Per Pack
The status in reference regulatory Lutigest 100 mg vaginal tablets by M/s Ferring
authorities Pharmaceuticals, MHRA Approved.
Lutinus 100mg Vaginal Tablets by M/s Ferring
Ireland Limites, HPRA Ireland Approved
For generic drugs (me-too status) Could not be confirmed

stability studies of drug substance and product.
Name, address of drug substance M/s Zhejiang Shenzhou Pharmaceutical Co., Ltd.
manufacturer 14 Chuancheng Nan Road China-317300 Xinaju,
Zhejiang Province
for related to nomenclature, structure, general
Stability Studies of Drug Substance CEP certificate is provided and the firm has stated
(Conditions & duration of Stability that the re-test period for the drug substance is 36
studies) months when stored in double PE bags placed in
carton drums.
Pharmaceutical Equivalence and The firm has submitted pharameutical equivalence
Comparative Dissolution Profile data against Endometrin Tablet 100mg by M/s
QPharma Ab, Sweden by performing all the
quality tests (VK292A).
Analytical method The firm has submitted relevant data including
validation/verification of product analytical method validation for the drug product
including the impurities
Container closure system of the drug Blisters of PVC/PVDC 90 g/m2 pharmaceutical
product white foil and aluminium lidding foil, primary
packaging
carton box containing blister nad leaflet as
secondary packaging.
Stability study data of drug product, • 12 months data of 3 batches at 30±20C,
shelf life and storage conditions 75±5%RH
• 6 months at 400C±75%RH of 03 batches.
• Firm Submitted CEP (Certification of suitability of European Pharmacopoeia
monographs) for Progesterone Micronised, non-micronised API which is verified by
EDQM website dated 27-12-2019 link attached:

https://extranet.edqm.eu/4DLink1/4DCGI/Query_CEP?vSelectName=1&Case_
TSE=none&vContains=1&vContainsDate=1&vtsubName=
Progesterone&vtsubDateBegin=&vtsubDateBtwBegin=&
vtsubDateBtwEnd=&SWTP=1&OK=Search
• Vaginal tablets are solid, single-dose preparations. They generally conform to the definitions
of uncoated or film-coated tablets given in the monograph (British Pharmacopoeia).
• Disintegration (2.9.2)
Unless intended for prolonged local action, they comply with the test (special method for
vaginal tablets). Examine the state of the tablets after 30 min, unless otherwise justified and
authorised. Disintegration test along with the dissolution test (≥80% in 30mins) is included
in the final specifications (release and shelf life) of the drug product.
• Moreover, the pharmaceutical equivalence studies have been performed in Dow University
of Health sciences at Bioanalytical Lab-IBBPS, Old TLA building 1st floor, DUHS-OJHA
Campus Karachi. The applicant has stated that the pharmaceutical equivalence is not a
regulatory requirement in exporting country that is why the studies have not been performed.
Decision of 313th meeting:
Since pharmaceutical equivalence and comparative dissolution are performed by Dow University
of Health Sciences at Bioanalytical Lab-IBBPS, Old TLA Building 1st Floor, DUHS-OJHA
Campus Karachi. The Board after deliberation deferred the case for clarification from the legal
division regarding the status of the submitted data of Pharmaceutical equivalence and comparative
dissolution profile.
• The firm has submitted comparative dissolution profile of the applied product against
Progesterone Vaginal Tablets 100mg (Lutinus tablet) by Ferring GmbH Wittland 11 D-24109
Kiel Germany (Batch No. YL314A) in all the 03 media that is 0.1N HCl, Acetate Buffer and
Phosphate Buffer (document No. RDP-PP-RT/020 dated 25/05/2022). The study is performed
by the manufacturer of the applied product.
• Moreover, the firm has submitted the results of Pharmaceutical Equivalence studies performed
by the manufacturer of the applied product against Lutinus tablet 100mg (B: YL314A).(Even
Document No., attachment 10).
05-2021.
38. Genetics Pharmaceuticals pvt ltd
a. Vepridone (Risperidone Prolonged Release Powder for Injection) 25mg

Dy. No 14162 Dated 05-08-2019 (Rs. 50,000/- Dated 05-08-2019)
MODULE 1: ADMINISTRATIVE
Section Sub- Heading
Section
1.1 Covering Letter and Fee Deposit Slip Submitted
1.2 Table of Contents (From Module 1 to Module 5) Submitted
1.3 Applicant Information Submitted
1.3.1 Name, address and contact details of Applicant / Marketing Authorization Holder:
M/s Genetics Pharmaceuticals pvt. Ltd. Ltd 539-A, Sundar Industrial Estate,
Raiwind Road Lahore
1.3.2 Name, address and contact details of Manufacturing site.

M/s Kwality Pharmaceuticals Ltd Vill. Nag Kalan, Majitha Road, Amritsar-143601
India
1.3.3 Specify whether the Applicant is:
Importer
1.3.4 Drug Sale License
No: 0011000 0000696 valid upto 12-December-2019
1.3.8 Manufacturer’s Site Master File and Credential (for importer)
Submitted
1.4 Type of Application Submitted
1.4.1 Application is for the registration of:
Generic Drug Product
1.4.1 Pharmaceutical product is intended for:
 Domestic sale
1.4.2 For imported products, please specify one of following:
 Finished Pharmaceutical Product Import
1.5 Detailed Information of Drug, Dosage From & Labelling Claims Submitted
1.5.1 Generic name with chemical name & synonyms of the applied drug.
Risperidone Extended-release Microspheres for injection 25mg/vial
Risperidone Extended-release Microspheres for injection 37.5mg/vial
1.5.2 Strength / concentration of drug of Active Pharmaceutical ingredient (API) per unit
Each vial contains:
Risperidone ……...25mg
2nd Strength
Each vial contains:
Risperidone ……...37.5mg
1.5.3 The proposed proprietary name / brand name under which the drug is intended to be
sold with trademark certification / clearance.
Vepridone (Risperidone Prolonged Release Powder for Injection)
1.5.4 Proposed Pack size and Proposed unit price of drug e.g., per tablet / capsule.
Maximum Retail Price (MRP) per pack shall also be mentioned.
1’s
1.5.5 Pharmacotherapeutic Group of Active Pharmaceutical Ingredient (API)
Antipsychotic
1.5.6 Pharmacopoeial reference / Status of applied formulation
In-house
1.5.7 Route of administration
IM
1.5.9 The registration status of applied drug in same molecule and salt, strength, dosage
form, container closure system, indications and route of administration etc. in other
countries. The status in reference regulatory authorities is mandatory to mention.
RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release
suspension for injection (UK)
RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release
suspension for injection
1.5.10 Dosage form of applied drug
Powder for Injection
1.5.11 Proposed label (outer (secondary) & inner (primary)) & colour scheme in
accordance with Drug (Labelling & Packing) Rules, 1986 along with specimens
Submitted
1.5.12 Description of Batch numbering system
1.5.14 Summary of Product Characteristics (SmPC) including Prescribing Information (PI)
along with Patient information Leaflet (PIL) of the Finished Pharmaceuticals
Product (FPP).
Submitted

1.5.15 Commitment / Undertaking that after registration of applied drug, the
Pharmacovigilance department of the applicant / manufacture is liable to impose
similar restrictions, addition of any clinical information (like in Indications, Contra-
indications, Side effects, Precautions, Dosage & A0dverse Drug Reactions etc. in
Summary of Product Characteristics (SmPC), Labelling & Promotional material) or
withdraw the drug from market in Pakistan within fourteen days after knowing that
such information (which was not available or approved by the DRAP at the time of
registration) / actions taken (for safety reasons) by any reference / stringent drug
regulatory agency / authority & also inform the DRAP (Drug Regulatory Authority
of Pakistan) for further action in this regard.
Submitted
1.5.16 Commitment / Undertaking that the applicant shall recall the defective Finished
Pharmaceutical Products (FPP) and notify the compliance to the authority along
with detail of actions taken by him as soon as possible but not more than ten days.
The level of recall shall also be defined.
Submitted
1.5.17 Commitment / Undertaking that in case of any false claim / concealing of
information, the DRAP has the right to reject the application at any time, before and
even after approval or registration of the product in case if proved so.
Submitted
1.5.18 Commitment / Undertaking that the firm shall follow the official pharmacopoeia
specifications for product / substance as published in the latest edition & shall update
its specification as per latest editions of the same. In case, the specifications of
product / substance not present in any official pharmacopoeia the firm shall establish
the specifications. In both cases, the validation of specifications shall be done by the
applicant.
Submitted
1.5.19 Commitment / Undertaking that in case of any post approval change, the applicant
shall ensure that the product with both approvals shall not be available in the market
at the same time. And the product with new approvals shall be marketed only after
consumption / withdrawal of stock with previous approvals. The company shall be
liable to inform the same regarding marketing status of product to the DRAP after
getting such post-registration approvals.
Submitted
1.5.20 Other commitment e.g., regarding stability studies etc.
1.5.21 Protocols along with the commitment to follow Good Laboratory Practices (GLP)
by the Manufacturer.
1.5.22 Protocols to implement Good Pharmacovigilance Practice by the
Pharmacovigilance department/section of the Manufacturer / Company.
1.6 Miscellaneous Information Submitted
1.6.1 Information on Prior-related Applications
1.6.2 Appendix
1.6.3 Electronic Review Package
1.6.4 QIS (Quality Information Summary)
1.6.5 Drug Substance related Document including following:
Name and address of API manufacturer.
M/s Jubilant Lifesciences Limited Block 133, village samlaya, Taluka Savli, Distt.
Vadodara-391520, Gujrat India
• Copy of Legalized, Notarized CoPP for Risperidone Pronged Release Powder for
Injection 25mg (Certificate#. 4892/2019) dated 03-04-2019 issued by Commissionerate,
FDA Punjab India declaring the free sale of applied product and GMP compliant status
of the manufacturer i.e M/s Kwality Pharmaceuticals Ltd Vill. Nag Kalan, Majitha Road,
Amritsar-143601 India
Certificate valid upto: 11/03/2021

Injection 37.5mg (Certificate#. 4893/2019) dated 03-04-2019 issued by
Commissionerate, FDA Punjab India declaring the free sale of applied product and GMP
compliant status of the manufacturer i.e M/s Kwality Pharmaceuticals Ltd Vill. Nag
Kalan, Majitha Road, Amritsar-143601 India
(Firm has submitted in reply of photocopy of CoPP legalized and Notarized“The
Pakistan Embassy & notary public in India do not attest the original CoPP, they
only attest the photocopy”)
• Sole agency agreement Between Product License Holder M/s Kwality Pharmaceuticals
Ltd Vill. Nag Kalan, Majitha Road, Amritsar-143601 India and Importer M/s Genetics
Pharmaceuticals pvt. Ltd. Ltd 539-A, Sundar Industrial Estate, Raiwind Road Lahore
dated 28-12-2018
MODULE 2: CTD SUMMARIES
2.1 Overall CTD Table of Content Submitted

2.2 CTD Introduction Submitted
2.3 Quality Overall Summary (QOS)* Submitted
QUALITY OVERALL SUMMARY (QOS)

2.3 Drug substance (API)
General information Submitted
Manufacture Submitted
Characterization Submitted
Control of drug substance Submitted
Reference standards Submitted
Container closure system Submitted
Stability Submitted
Drug product
Description and composition of the drug product Submitted
Pharmaceutical development Submitted
Components of the drug product
2.3.P.2.1.1 Drug substance (API) Submitted
2.3.P.2.1.2 Excipients Submitted
Finished Pharmaceutical Product Submitted
Manufacturing process development Submitted
Control of excipients Submitted
Control of drug product Submitted
Reference standards and materials Submitted
Stability Submitted
2.4 Non-Clinical Overview Submitted
2.5 Clinical Overview Submitted

2.6 Non-Clinical Written and Tabulated Summaries (Normally not required for generics)
Submitted
2.7 Clinical summary Submitted
MODULE 3: QUALITY
3.1 Table of Contents of Module 3 Submitted
3.2 Body of Data Submitted

3.2.S DRUG SUBSTANCE (API)
3.2.S.1 GENERAL INFORMATION (May not refer to DMF)
3.2.S.1.1 Nomenclature Submitted

3.2.S.1.2 Structure Submitted
3.2.S.1.3 General properties Submitted
3.2.S.2 MANUFACTURER
3.2.S.2.1 Manufacturer(s) Submitted
3.2.S.2.2 Description of Manufacturing Process and Process Controls Submitted
3.2.S.2.3 Control of Materials Submitted
3.2.S.2.4 Control of Critical steps and intermediates Not Submitted
3.2.S.2.5 Process Validation and/or Evaluation Not submitted
3.2.S.2.6 Manufacturing process development not Submitted
CHARACTERIZATION
3.2.S.3 3.2.S.3.1 Elucidation of Structure and other Characteristics Submitted
3.2.S.3.2 Impurities Submitted
3.2.S.4 CONTROL OF DRUG SUBSTANCE (API)
3.2.S.4.1 Specification Submitted
3.2.S.4.2 Analytical procedures Submitted
3.2.S.4.3 Validation of analytical procedures Submitted
Batch analysis
Certificate of analysis (COA) specifications and test results from drug
substance (API) manufacturer(s)
3.2.S.4.4 Drug product manufacturer’s certificate of analysis with API lot numbers
3.2.S.4.5 Justification of specifications Submitted
3.2.S.5 REFERENCE STANDARDS Submitted
3.2.S.6 CONTAINER CLOSURE SYSTEMS Submitted
3.2.S.7 STABILITY
3.2.S.7.1 Stability Summary and Conclusions Submitted
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment Submitted
3.2.S.7.3 Stability Data Submitted
3.2.P DRUG PRODUCT

3.2.P.1 DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT Submitted
3.2.P.2 PHARMACEUTICAL DEVELOPMENT
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance Submitted
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development Submitted
3.2.P.2.2.2 Overages Submitted
3.2.P.2.2.3 Physicochemical and Biological Properties Submitted
3.2.P.2.3 Manufacturing Process Development Submitted
3.2.P.2.4 Container Closure System Submitted
3.2.P.2.5 Microbiological Attributes Submitted
3.2.P.2.6 Compatibility Not applicable
3.2.P.3 MANUFACTURE

3.2.P.3.1 Manufacturer(s) Submitted
Name and full address(es) of the facility(i.e.)
Contact name, phone and fax numbers, email address

3.2.P.3.2 Batch formula Submitted
3.2.P.3.3 Description of manufacturing process and process controls Submitted
3.2.P.3.4 Controls of critical steps and intermediates Submitted
3.2.P.3.5 Process validation and/or evaluation Submitted
3.2.P.4 CONTROL OF EXCIPIENTS
3.2.P.4.1 Specifications Submitted
3.2.P.4.2 Analytical procedures Submitted
3.2.P.4.3 Validation of analytical procedures Submitted
3.2.P.4.4 Justification of specifications (as applicable) Submitted
3.2.P.4.5 Excipients of human or animal origin Submitted
3.2.P.4.6 Novel excipients Submitted
3.2.P.5 CONTROLS OF DRUG PRODUCT
3.2.P.5.1 Specification(s) Submitted
3.2.P.5.4 Batch analysis Submitted
3.2.P.5.5 Characterization of impurities Not submitted
Firm submit substance related impurities and claim that “we confirm
impurities in finished product will be well within the limit.
3.2.P.5.6 Justification of specifications Submitted
3.2.P.6 Reference Standards or Materials Submitted
3.2.P.7 CONTAINER CLOSURE SYSTEM Submitted
3.2.P.8 STABILITY
3.2.P.8.1 Stability summary and conclusion (Finished Dosage Form) Submitted
Stability protocol submitted
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment Submitted
3.2.P.8.3 Stability Submitted
Firm has submitted three batches long term stability data 3 batches 36 months
at 30±20C,75%RH and 6 months at 400C±75%RH for three batches for applied
strengths separately.
nd
Deferred due to following:
i. Importable from India as per IPO
ii. Provided photocopy of CoPP legalized not original.
iii. Submissionof relevant informationagainst section 3.2.P.5.5 (Characterization of
Impurities.)
• Original legalized CoPP (certificate No. 5375/2019 issued for Vepridone 25mg) valid till
13/11/2021 issued by Food and Drugs Administration Punjab, India.
The applied product is present for free sale in the market of exporting country.
Product License holder and Manufacturer: M/s Kwality Pharmaeucticals Limited, Village Nag
Kalan, Majitha road, Amritsar, Punjab, India.
• Original legalized CoPP (certificate No. 5374/2019 issued for Vepridone 37.5mg) valid till
13/11/2021 issued by Food and Drugs Administration Punjab, India.

Product License holder and Manufacturer: M/s Kwality Pharmaeucticals Limited, Village Nag
Kalan, Majitha road, Amritsar, Punjab, India.
• The firm has submitted relevant details regarding characterization of impurities.
The Board decided to refer the case to DRAP’s Authority in light of its decision regarding importability
from India.
Evaluation by PEC:
The case was placed in 136th meeting of the Authority for deciding whether the applied product is
importable form India or otherwise. The authority has decided as follows:
“The Authority after due deliberation noted that as Risperidone 25mg & 37.5mg Extended Release
Microsphere Injection having HS code 3004.4900, is importable from India under Import Policy
Order-2016, so Registration Board may take its decision keeping in view the safety, efficacy and
quality of the applied product”.
Decision: Approved with innovator’s specifications as per Policy for inspection of Manufacturer
abroad and verification of local storage facility. Registration Board further decided that
registration letter will be issued after submission of applicable fee that is Rs. 7,500/- for revision
b. Vepridone (Risperidone Prolonged Release Powder for Injection) 37.5mg
MODULE 1: ADMINISTRATIVE
Section Sub- Heading
Section
1.1 Covering Letter and Fee Deposit Slip Submitted
1.2 Table of Contents (From Module 1 to Module 5) Submitted
1.3 Applicant Information Submitted
1.3.1 Name, address and contact details of Applicant / Marketing Authorization Holder:
M/s Genetics Pharmaceuticals pvt. Ltd. Ltd 539-A, Sundar Industrial Estate,
Raiwind Road Lahore
1.3.2 Name, address and contact details of Manufacturing site.
M/s Kwality Pharmaceuticals Ltd Vill. Nag Kalan, Majitha Road, Amritsar-143601
India
1.3.3 Specify whether the Applicant is:
Importer
1.3.4 Drug Sale License
No: 0011000 0000696 valid upto 12-December-2019
1.3.8 Manufacturer’s Site Master File and Credential (for importer)
Submitted
1.4 Type of Application Submitted
1.4.1 Application is for the registration of:
Generic Drug Product
1.4.1 Pharmaceutical product is intended for:
 Domestic sale
1.4.2 For imported products, please specify one of following:
 Finished Pharmaceutical Product Import
1.5 Detailed Information of Drug, Dosage From & Labelling Claims Submitted
1.5.1 Generic name with chemical name & synonyms of the applied drug.
Risperidone Extended-release Microspheres for injection 25mg/vial
Risperidone Extended-release Microspheres for injection 37.5mg/vial
1.5.2 Strength / concentration of drug of Active Pharmaceutical ingredient (API) per unit
Each vial contains:

Risperidone ……...37.5mg
1.5.3 The proposed proprietary name / brand name under which the drug is intended to be
sold with trademark certification / clearance.
Vepridone (Risperidone Prolonged Release Powder for Injection)
1.5.4 Proposed Pack size and Proposed unit price of drug e.g., per tablet / capsule.
Maximum Retail Price (MRP) per pack shall also be mentioned.
1’s
1.5.5 Pharmacotherapeutic Group of Active Pharmaceutical Ingredient (API)
Antipsychotic
1.5.6 Pharmacopoeial reference / Status of applied formulation
In-house
1.5.7 Route of administration
IM
1.5.9 The registration status of applied drug in same molecule and salt, strength, dosage
form, container closure system, indications and route of administration etc. in other
countries. The status in reference regulatory authorities is mandatory to mention.
RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release
suspension for injection (UK)
RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release
suspension for injection
1.5.10 Dosage form of applied drug
Powder for Injection
1.5.11 Proposed label (outer (secondary) & inner (primary)) & colour scheme in
accordance with Drug (Labelling & Packing) Rules, 1986 along with specimens
Submitted
1.5.12 Description of Batch numbering system
1.5.14 Summary of Product Characteristics (SmPC) including Prescribing Information (PI)
along with Patient information Leaflet (PIL) of the Finished Pharmaceuticals
Product (FPP).
Submitted
1.5.15 Commitment / Undertaking that after registration of applied drug, the
Pharmacovigilance department of the applicant / manufacture is liable to impose
similar restrictions, addition of any clinical information (like in Indications, Contra-
indications, Side effects, Precautions, Dosage & A0dverse Drug Reactions etc. in
Summary of Product Characteristics (SmPC), Labelling & Promotional material) or
withdraw the drug from market in Pakistan within fourteen days after knowing that
such information (which was not available or approved by the DRAP at the time of
registration) / actions taken (for safety reasons) by any reference / stringent drug
regulatory agency / authority & also inform the DRAP (Drug Regulatory Authority
of Pakistan) for further action in this regard.
Submitted
1.5.16 Commitment / Undertaking that the applicant shall recall the defective Finished
Pharmaceutical Products (FPP) and notify the compliance to the authority along
with detail of actions taken by him as soon as possible but not more than ten days.
The level of recall shall also be defined.
Submitted
1.5.17 Commitment / Undertaking that in case of any false claim / concealing of
information, the DRAP has the right to reject the application at any time, before and
even after approval or registration of the product in case if proved so.
Submitted
1.5.18 Commitment / Undertaking that the firm shall follow the official pharmacopoeia
specifications for product / substance as published in the latest edition & shall update
its specification as per latest editions of the same. In case, the specifications of
product / substance not present in any official pharmacopoeia the firm shall establish

the specifications. In both cases, the validation of specifications shall be done by the
applicant.
Submitted
1.5.19 Commitment / Undertaking that in case of any post approval change, the applicant
shall ensure that the product with both approvals shall not be available in the market
at the same time. And the product with new approvals shall be marketed only after
consumption / withdrawal of stock with previous approvals. The company shall be
liable to inform the same regarding marketing status of product to the DRAP after
getting such post-registration approvals.
Submitted
1.5.20 Other commitment e.g., regarding stability studies etc.
1.5.21 Protocols along with the commitment to follow Good Laboratory Practices (GLP)
by the Manufacturer.
1.5.22 Protocols to implement Good Pharmacovigilance Practice by the
Pharmacovigilance department/section of the Manufacturer / Company.
1.6 Miscellaneous Information Submitted
1.6.1 Information on Prior-related Applications
1.6.2 Appendix
1.6.3 Electronic Review Package
1.6.4 QIS (Quality Information Summary)
1.6.5 Drug Substance related Document including following:
Name and address of API manufacturer.
M/s Jubilant Lifesciences Limited Block 133, village samlaya, Taluka Savli, Distt.
Vadodara-391520, Gujrat India
Injection 25mg (Certificate#. 4892/2019) dated 03-04-2019 issued by Commissionerate,
FDA Punjab India declaring the free sale of applied product and GMP compliant status
of the manufacturer i.e M/s Kwality Pharmaceuticals Ltd Vill. Nag Kalan, Majitha Road,
Amritsar-143601 India
Injection 37.5mg (Certificate#. 4893/2019) dated 03-04-2019 issued by
Commissionerate, FDA Punjab India declaring the free sale of applied product and GMP
compliant status of the manufacturer i.e M/s Kwality Pharmaceuticals Ltd Vill. Nag
Kalan, Majitha Road, Amritsar-143601 India
(Firm has submitted in reply of photocopy of CoPP legalized and Notarized“The
Pakistan Embassy & notary public in India do not attest the original CoPP, they
only attest the photocopy”)
• Sole agency agreement Between Product License Holder M/s Kwality Pharmaceuticals
Ltd Vill. Nag Kalan, Majitha Road, Amritsar-143601 India and Importer M/s Genetics
Pharmaceuticals pvt. Ltd. Ltd 539-A, Sundar Industrial Estate, Raiwind Road Lahore
dated 28-12-2018
MODULE 2: CTD SUMMARIES
2.1 Overall CTD Table of Content Submitted

2.2 CTD Introduction Submitted
2.3 Quality Overall Summary (QOS)* Submitted
QUALITY OVERALL SUMMARY (QOS)

2.3 Drug substance (API)
General information Submitted
Characterization Submitted
Control of drug substance Submitted
Reference standards Submitted
Stability Submitted
Drug product
Description and composition of the drug product Submitted
Pharmaceutical development Submitted
Components of the drug product
2.3.P.2.1.1 Drug substance (API) Submitted
Finished Pharmaceutical Product Submitted
Manufacturing process development Submitted
Control of excipients Submitted
Control of drug product Submitted
Reference standards and materials Submitted
Stability Submitted
2.4 Non-Clinical Overview Submitted
2.5 Clinical Overview Submitted

2.6 Non-Clinical Written and Tabulated Summaries (Normally not required for generics)
Submitted
2.7 Clinical summary Submitted
MODULE 3: QUALITY
3.1 Table of Contents of Module 3 Submitted
3.2 Body of Data Submitted
3.2.S DRUG SUBSTANCE (API)

3.2.S.1 GENERAL INFORMATION (May not refer to DMF)
3.2.S.1.1 Nomenclature Submitted

3.2.S.1.2 Structure Submitted
3.2.S.1.3 General properties Submitted
3.2.S.2 MANUFACTURER
3.2.S.2.1 Manufacturer(s) Submitted
3.2.S.2.2 Description of Manufacturing Process and Process Controls Submitted
3.2.S.2.3 Control of Materials Submitted
3.2.S.2.4 Control of Critical steps and intermediates Not Submitted
3.2.S.2.5 Process Validation and/or Evaluation Not submitted
3.2.S.2.6 Manufacturing process development not Submitted
CHARACTERIZATION
3.2.S.3 3.2.S.3.1 Elucidation of Structure and other Characteristics Submitted
3.2.S.3.2 Impurities Submitted
3.2.S.4 CONTROL OF DRUG SUBSTANCE (API)
3.2.S.4.1 Specification Submitted
3.2.S.4.2 Analytical procedures Submitted
3.2.S.4.3 Validation of analytical procedures Submitted

Batch analysis
Certificate of analysis (COA) specifications and test results from drug
substance (API) manufacturer(s)
3.2.S.4.4 Drug product manufacturer’s certificate of analysis with API lot numbers
3.2.S.4.5 Justification of specifications Submitted
3.2.S.5 REFERENCE STANDARDS Submitted
3.2.S.6 CONTAINER CLOSURE SYSTEMS Submitted
3.2.S.7 STABILITY
3.2.S.7.1 Stability Summary and Conclusions Submitted
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment Submitted
3.2.S.7.3 Stability Data Submitted
3.2.P DRUG PRODUCT

3.2.P.1 DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT Submitted
3.2.P.2 PHARMACEUTICAL DEVELOPMENT
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance Submitted
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development Submitted
3.2.P.2.2.2 Overages Submitted
3.2.P.2.2.3 Physicochemical and Biological Properties Submitted
3.2.P.2.3 Manufacturing Process Development Submitted
3.2.P.2.4 Container Closure System Submitted
3.2.P.2.5 Microbiological Attributes Submitted
3.2.P.2.6 Compatibility Not applicable
3.2.P.3 MANUFACTURE
3.2.P.3.1 Manufacturer(s) Submitted
Name and full address(es) of the facility(i.e.)
Contact name, phone and fax numbers, email address

3.2.P.3.2 Batch formula Submitted
3.2.P.3.3 Description of manufacturing process and process controls Submitted
3.2.P.3.4 Controls of critical steps and intermediates Submitted
3.2.P.3.5 Process validation and/or evaluation Submitted
3.2.P.4 CONTROL OF EXCIPIENTS
3.2.P.4.1 Specifications Submitted
3.2.P.4.4 Justification of specifications (as applicable) Submitted
3.2.P.4.5 Excipients of human or animal origin Submitted
3.2.P.4.6 Novel excipients Submitted
3.2.P.5 CONTROLS OF DRUG PRODUCT
3.2.P.5.1 Specification(s) Submitted
3.2.P.5.4 Batch analysis Submitted
3.2.P.5.5 Characterization of impurities Not submitted
Firm submit substance related impurities and claim that “we confirm
impurities in finished product will be well within the limit.
3.2.P.5.6 Justification of specifications Submitted

3.2.P.6 Reference Standards or Materials Submitted
3.2.P.7 CONTAINER CLOSURE SYSTEM Submitted
3.2.P.8 STABILITY
3.2.P.8.1 Stability summary and conclusion (Finished Dosage Form) Submitted
Stability protocol submitted
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment Submitted
3.2.P.8.3 Stability Submitted
Firm has submitted three batches long term stability data 3 batches 36 months
at 30±20C,75%RH and 6 months at 400C±75%RH for three batches for applied
strengths separately.
Decision of 292nd meeting:
Deferred due to following:
iv. Importable from India as per IPO
v. Provided photocopy of CoPP legalized not original.
vi. Submissionof relevant informationagainst section 3.2.P.5.5 (Characterization of Impurities.)
• Original legalized CoPP (certificate No. 5375/2019 issued for Vepridone 25mg) valid till 13/11/2021 issued
by Food and Drugs Administration Punjab, India.
Product License holder and Manufacturer: M/s Kwality Pharmaeucticals Limited, Village Nag Kalan,
Majitha road, Amritsar, Punjab, India.
• Original legalized CoPP (certificate No. 5374/2019 issued for Vepridone 37.5mg) valid till 13/11/2021
issued by Food and Drugs Administration Punjab, India.
Product License holder and Manufacturer: M/s Kwality Pharmaeucticals Limited, Village Nag Kalan,
Majitha road, Amritsar, Punjab, India.
• The firm has submitted relevant details regarding characterization of impurities.
The Board decided to refer the case to DRAP’s Authority in light of its decision regarding importability from
India.
Evaluation by PEC:
The case was placed in 136th meeting of the Authority for deciding whether the applied product is importable
form India or otherwise. The authority has decided as follows:
“The Authority after due deliberation noted that as Risperidone 25mg & 37.5mg Extended Release Microsphere
Injection having HS code 3004.4900, is importable from India under Import Policy Order-2016, so Registration
Board may take its decision keeping in view the safety, efficacy and quality of the applied product”.
Decision: Approved with innovator’s specifications as per Policy for inspection of Manufacturer abroad
and verification of local storage facility. Registration Board further decided that registration letter will
be issued after submission of applicable fee that is Rs. 7,50/- for revision of specifications as per
39. Name and address of Applicant M/s The Searle Company Limited,
1st floor, N.I.C.L building Abbasi Shaheed Road,
Karachi
Detail of Drug Sale License License No.: 016
Address: The Searle company limited, Plot No. F-319,
S.I.T.E., Karachi
Godown:
1. Plot No. section 1f-2/Q SITE Karachi.
2. Plot No. 54 Dedhu pass tapo gabo pat Baldia town
Karachi.
Status: Drug sale license by the way of wholesale

Name and address of manufacturer M/s Midascare Pharmaceuticals Pvt. Ltd. B-16, MIDC
Waluj, Aurangabad 431 136, India
Name and address of marketing M/s Midascare Pharmaceuticals Pvt. Ltd. B-16, MIDC
authorization holder Waluj, Aurangabad 431 136, India
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No.2145 Dated 01/11/2016
Fee including differential fee Rs. 100,000/- Dated 28/10/2016
Brand Name +Dosage Form + Strength FLUSAL 125 HFA Inhaler 25mcg/125mcg
Composition Each actuation delivers:
Salmeterol as xinafoate…….. 25mcg
Fluticasone propionate…... 125mcg
Finished Product Specification In House
Pharmacological Group Adrenergics, corticosteroids
Shelf life 24 motnhs
Demanded Price As per DPC
Pack size 1’s
International availability Seroflo (25mcg/125mcg and 25mcg/250mcg) Inhaler
by M/s Fanin Uk Ltd. (MHRA approved)
Me-too status Saltra Inhaler (25mcg/125mcg and 25mcg/250mcg) by
M/s Getz Pharma (Reg No. 081557)
Detail of certificates attached
• Original legalized Free sale Certificate (FSC) (certificate No. 6094076) issued by FDA
Maharashtra State, India valid till 29/05/2021. Following product are available for free sale in
exporting country as per FSC.
Flusal 50 HFA 25mcg/50mcg
• Original legalized GMP (No. NEW-WHO-GMP/CERT/AD/88344/2019/11/30633) issued by
FDA Maharashtra, India valid till 25/12/2022.
• sole agency agreement is submitted whereby M/s Midas Care Pharmaceuticals pvt. Ltd.,
authorized M/s The Searle Company Limited as an agent for Flusal 50, Flusal 250 and Flusal
125.
Stability studies Long term/ Real time: 30°C ± 2°C / 75% ± 5%RH for
24 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Remarks of the Evaluator. • The firm has claimed In House manufacturing
specifications while the product is present in BP and
USP.
Validity of FSC is 29/05/2021.
Deferred for confirmation for importability from India as per DRAP’s Authority decision.
• The firm has stated that as per Import Policy Order 2016, the applied product does not come
under Apendix-G (list of non-importable products).
• Fluticasone propionate is Corticosteroid.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076504_original%20approval_package.pdf
(REF: USFDA, accessed 22/07/2022)
• Salmeterol Xinofoate is Beta-2 Adrenergic Bronchodilator.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf (Ref: USFDA
Accessed on 22/07/2022).
• However, as per import policy order serial No. 66 of Appendix G “Containing Corticosteroid
Hormones, Their Derivatives or Structural Analogues”.

Decision: The Board discussed the case in detail regarding importability from India and decided to
defer the case for seeking guidance from DRAP Authority for importability of the applied product
from India as import policy order 2016 and DRAP’s Authority decision.
Karachi
S.I.T.E., Karachi
Godown:
Karachi.
Name and address of manufacturer M/s Midascare Pharmaceuticals Pvt. Ltd. B-16, MIDC
Fluticasone propionate…... 50mcg
Pack size 1’s
International availability Seretide Evohaler 25 microgram /50 microgram by
M/s Glaxo Wellcome UK Ltd (MHRA Approved)
Me-too status Salmicort inhaler 25mcg/50mcg by M/s Macter Int.
(Reg # 045209)
• sole agency agreement is submitted whereby M/s Midas Care Pharmaceuticals pvt. Ltd.,
authorized M/s The Searle Company Limited as an agent for Flusal 50, Flusal 250 and Flusal
125.
24 months

Remarks of the Evaluator. • The firm has claimed In House manufacturing
USP.

Karachi
S.I.T.E., Karachi
Godown:
Karachi.
Name and address of manufacturer M/s Midas care Pharmaceuticals Pvt. Ltd. B-16, MIDC
Fluticonasone propionate…... 250mcg
Pack size 1’s
International availability Seroflo (25mcg/125mcg and 25mcg/250mcg) Inhaler
by M/s Fanin Uk Ltd. (MHRA approved)

Me-too status Saltra Inhaler (25mcg/125mcg and 25mcg/250mcg) by
M/s Getz Pharma (Reg No. 081558)
• Copy of sole agency agreement is submitted whereby M/s Midas Care Pharmaceuticals pvt.
Ltd., authorized M/s The Searle Company Limited as an agent for Flusal 50, Flusal 250 and
Flusal 125.
24 months
Remarks of the Evaluator-I • The firm has claimed In House manufacturing
USP.

Case No. III: Import (Veterinary)

New Cases:
42. Name and address of M/s Atzan Pharmaceuticals, commercial area aziz Bhatti
Applicant town Sargodha
Detail of Drug Sale License DSL No. 0011000 0001644 valid up 14-Apr-2020
Name and address of M/s Vietnam Sakan Technology Development & Investment
manufacturer Joint Stock Company, Lot D1-D4 Dong Tho Industrial
Complex, Yen Phong District, BAC Ninh Province, Vietnam.
Marketing authorization M/s Vietnam Sakan Technology Development & Investment
holder Joint Stock Company, Lot D1-D4 Dong Tho Industrial
Complex, Yen Phong District, BAC Ninh Province, Vietnam.
Name of exporting country Vietnam
Diary No. & Date of R& I Dy. No 23395 Dated 07-12-2017
Fee including differential fee Rs. 100,000/- Dated 07-12-2017

Brand Name +Dosage Form + Cefquin 2.5 LA suspension for injection
Strength
Composition Each ml of suspension contains;
Cefquinome as sulfate……..25mg
Finished Product Specification In-House
Pharmacological Group Antiobiotic
Shelf life 24 months
Demanded Price Decontrolled.
Pack size 1’s (type I glass vial)
Me-too status COBACTAN 2.5% SUSPENSION FOR INJECTION
(50mL), Reg. No. 078219
Stability studies Firm has submitted long term (24 months) at 30oC 65±5%RH
& accelerated (06 months) stability data at 40oC, 75±5% RH
for three batches.
Detail of certificates attached ➢ Original Legalized Free Sale Certificate issued by
Ministry of Agriculture and Rural Development,
Department of Animal Health Vietnam (certificate no.
494/2017/QLT-CFS) dated 26/06/2017 is submitted.
➢ Copy of GMP certificate (No.23/22/GCN-GMP) dated
25/07/2022 issued by Ministry of Agriculture and Rural
Development. The certificate is valid for 05 years. As
per copy of GMP certificate the manufacturer has
production lines of Beta-Lactam in the form
suspension for Injection.
➢ Copy of authorization letter is submitted through which
M/s Atzan Pharmaceuticals is appointed as agent for
different products including the applied product.
Remarks of the Evaluator:
Since registration of injections is granted The firm has requested for 50mL filled
with 01filled volume but you have applied volume.
for 03, therefore, select 01 filled volume Me too: COBACTAN 2.5%
of the applied product along with the SUSPENSION FOR INJECTION
stability study data conducted under the (50mL), Reg. No. 078219
conditions of zone IV-A of 03 batches of
relevant filled volume, please. Moreover,
provide me-too status of the applied
product in same filled volume as selected.
Submit valid copy of drug sale license. The firm has submitted receipt for renewal
of DSL.
Ref No. 384-11940097-2022
Add: 13-E, Commercial area, Aziz Bhatti
Town, District Sargodha.
Detail of primary packaging material is Type I glass vial, 50mL.
required.
Decision: The Board discussed that B-Lactam preparations include Penecillins as well
as Cephalosporins and submitted copy of GMP certificate does not clarify that the
production lines of manufacturer are for Penecillins or Cephalosporins. Keeing in view,
the Board decided to defer the case for further clarification of availability of
manufacturing failcity for the applied product.
Deferred cases:
43. Name and address of Applicant M/s HPI Pharma, Bao wala Opposite truck stand gate
no. 2 Rasheed Abad, Jhang Road Faisalabad.
Detail of Drug Sale License Drug License by way of wholesale
Address: HPI Pharma, Ground floor P-171 Medol
Town-B, District Faisalabad.
Karachi.
Manufacturer & Product License Manufacturer & MAH:
Holder M/s Industrial Veterinaria, S.A Esmeralda 19, 08950
Espulgues de Llobregat Barcelona, Spain.
Name of exporting country spain
Diary No. & Date of R& I Dy. No 5170-B Dated 06/02/2019
Brand Name +Dosage Form + Pluscolan concentrate for oral solution
Strength
Composition Each ml contaions:
Colistin sulfate……..5,000,000 IU
Finished Product Specification In house
Pharmacological Group Antibiotic
Shelf life 2 years
Pack size & Demanded Price 100ml, 1litre, 5litre, price decontrolled
Me-too status
Stability studies 24 moths real time and 06 months accelerated of 3
batches as per ZONE IV-A.
Detail of certificates attached Original legalized free sale certificate issued on
06/07/2018, the product is freely sold in exporting
country and the manufacturer conforms to WHO-GMP
as per the certificate.
Remarks of the Evaluator. Clarification is required since the submitted documents
(free sale certificate and stability study data) along with
the dossier show that the applied product contains Colistin
Sulfate (in terms of international units IUs) while the
calculation of IU’s is based upon the activity of base only.
Submit drug product specification data in the light of
decision of Registration Board in its 267th meeting.
Provide evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
Decision: Deferred for the following:
• Clarification is required since the submitted documents (free sale certificate and stability
study data) along with the dossier show that the applied product contains Colistin Sulfate (in
terms of international units IUs) while the calculation of IU’s is based upon the activity of
base only.
• Submit drug product specification data in the light of decision of Registration Board in its
267th meeting.
• Provide evidence of applied formulation/drug already approved by DRAP (generic / me-
too status) along with registration number, brand name and name of firm.
• The firm has stated that the applied product will be imported from Spain and is
approved by the Spanish authority (CimaVet). The approval status of the applied
product is verified from available online data base of Spanish Authority.
The composition of the applied product is:

file:///C:/Users/farooq.aslam/Downloads/FT_3204%20ESP%20(2).pdf (Accessed on
22/07/2022 at 12:40pm).
• As per the document No. EMEA/MRL/016/95-Final (Summary Report for colistin)
issued by Committee for Veterinary Medical Products, Colistin Base has been
assigned a potency of 1000ug base activity per mg (30,000 IU/mg) and theoretical
potency of Colistin Sulphate is 800ug per mg (24,000IU/mg).
https://www.ema.europa.eu/en/documents/mrl-report/colistin-summary-report-1-
committee-veterinary-medicinal-products_en.pdf (accessed on 22/07/2022 at
1:10pm).
• The firm has stated that the formulation is not present in any pharmacopoeia therefore
Innovator’s specifications may be granted. Initially the firm had applied for In-House
specifications.
• Me-too status: COLISTIN WATER SOLUBLE POWDER Reg. No. 071022 by M/s
Biogen Pharma.
decided that registration letter will be issued after submission of applicable fee of Rs. 7,500/-
for revision of specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Case No IV: Registration application submitted on form 5

Deferred Cases of Form 5 Local Manufacturing:
Covid cases:
Sr. Name of Brand Composition Dy.No. /
Last Remarks
No. applicant/manufacturer name Date / Fee
Inspection
report
44. M/s Biorex Bioquine Each Film Coated Dy. Last
Pharmaceuticasl plot 200mg Tablet contains: No.7617 inspection
No. 251-A, Industrial tablet Hydroxychloroquine dated report is
Triangle Kahuta Road, sulfate ……200mg 15/04/2020 older than
Islamabad. Rs. 3 years.
Pack size and price: 20,000/- The firm
As per SRO Form 5 has applied
for
uncoated
tablet in
contrast to
innovator’s
product.
Deferred for the following:
Submission of evidence of approval of applied formulation as “uncoated 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.
Referred the case to QA & LT Division to conduct GMP inspection of the firm on priority.
The firm has:
• Revised the formulation from uncoated tablet to film coated tablet and submitted fee of Rs.
7500/- vide challan number 6594010172 dated 24/05/2022.

• Last inspection report dated 28/09/2021, 21/10/2021, 09/12/2021 is submitted. The panel
recommended for the renewal of DML for Tablet (General) section, Capsule (General), Capsule
(Ceph), Dry Suspension (Ceph), Dry Powder Injection (Ceph) and for additional sections Syrup
(General), Dry Suspension (General), Liquid Injectable (Ampoule), Liquid Injectable (Vial),
Creams/Ointments (Topical General), Lotions/Gels (Topical General).
Decision: Registration Board approved the registration of the applied product. Conditions
regarding validity of registration and data requirement will be same as decided by the Board in
its general decision recorded in its 295th meeting.
Routine Cases (Deferred Form 5):

45. 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 + Doxetal 80mg/2ml Injection
Strength
Diary No. Date of R& I & fee Dy. No 5589 dated 07-02-2019 Rs.20,000/-
Composition Each injection vial contains:
Docetaxel……80mg
Pharmacological Group plant alkaloids and other natural products
Type of Form Form-5
Finished Product Specification USP
Pack Size & Demanded Price Asper SRO
Approval Status of Product in Approved in TGA Australia (DOCETAXEL AN
Reference docetaxel 80mg/2mL concentrated solution for
Regulatory Authorities injection vial with diluent vial)
Me-too Status Plustaxano Anhidro 80mg/2ml Concentrate
Solution for Infusion of M/s. Ghani brothers Reg.
no. 044885 (registered in import)
GMP Status GMP inspection conducted on 19.09.2018
concluded
satisfactory level of GMP compliance.
Remarks of the Evaluator. Terminal sterilization not mentioned
• Packaging material not mentioned submit
separate
application for diluent
Previous Decision of Registration Deferred for the following:
Board (M-296) • Submit justification on scientific grounds for not
performing terminal
sterilization of applied formulation.
• Mention type of primary packaging material of
applied formulation
whether it is type I, II, or III glass container.
• Status of Diluent whether it is combo pack or
otherwise.
Response of the Firm • Firm informed that revised method of
manufacturing has been
submitted with terminal sterilization process.
• Primary packaging material is Glass vial Type-I
• Firm stated that they have already given
registration of higher strength
of same formulation in 275th meeting of
Registration Board in which the approval has been
granted with 9ml diluent. So, firm has demanded
for combo pack with diluent.

Deferred for clarification regarding availability of diluent whether, it will be procured or it
will
be self-manufactured. In case of self-manufacturing of diluent by M/s Rotex Pharma Pvt
Ltd., firm shall submit manufacturing process along with detail of manufacturing area in
which the diluent will be manufactured.
• The firm has stated that the diluent will be self-manufactured in Liquid vial (SVP)
Oncology section. The approval of the section was granted vide letter No. F.1-53/2003-
Lic(Vol-I) dated 13/06/2017.
• Copy of GMP certificate No. F.3-55/2020-Addl.Dir.(QA&LT-1) issued n the basis of
inspection conducted on 12/08/2020.
• The firm has submitted complete method of manufacturing for manufacturing of the
diluent.
• The firm has the registration of another strength of Docetaxel Injection 120mg/6mL
along with the diluent 9mL (Reg. No. 092154) approved in 275th meeting.
• The composition of diluent is as per the product approved by TGA Australia.
Label claim:
Each vial (2mL) contains:
Docetaxel……..80mg
Composition of diluent:
Each vial (6.5mL) contains:
Ethanol absolute……0.845mL
Water for injection….6.5mL (q.s)
Decision: The Board deliberated that the applied product is in combo pack and the
diluent will be manufactured by the manufacturer, therefore the Board approved the
case and decided that the applicant will submit full fee that is Rs. 30,000/- for revision of
composition of diluent as per reference product before issuance of registration letter.
Brand Name +Dosage Form + Doxetal 20mg/0.5ml Injection
Strength
Composition Each injection vial contains:
Docetaxel……20mg
Pharmacological Group plant alkaloids and other natural products
Type of Form Form-5
Pack Size & Demanded Price 1’s(0.5ml) vial: As per SRO
Approval Status of Product in Approved in TGA Australia (DOCETAXEL AN
Reference docetaxel 80mg/2mL concentrated solution for
Regulatory Authorities injection vial with diluent vial)
Me-too Status Plustaxano Anhidro 80mg/2ml Concentrate
Solution for Infusion of M/s. Ghani brothers Reg.
no. 044885 (registered in import)
concluded
• Packaging material not mentioned submit separate
performing terminal

applied formulation
whether it is type I, II, or III glass container.
• Status of Diluent whether it is combo pack or
otherwise.
Response of the Firm • Firm informed that revised method of
manufacturing has been
submitted with terminal sterilization process.
• Primary packaging material is Glass vial Type-I
• Firm stated that they have already given
registration of higher strength
of same formulation in 275th meeting of
Registration Board in which the approval has been
granted with 9ml diluent. So, firm has demanded for
combo pack with diluent.
will
be self-manufactured. In case of self-manufacturing of diluent by M/s Rotex Pharma Pvt Ltd.,
firm shall submit manufacturing process along with detail of manufacturing area in which the
diluent will be manufactured.
• The firm has stated that the diluent will be self-manufactured in Liquid vial (SVP)
Oncology section. The approval of the section was granted vide letter No. F.1-53/2003-
Lic(Vol-I) dated 13/06/2017.
inspection conducted on12/08/2020.
• The firm has submitted complete method of manufacturing for manufacturing of the
diluent.
• The firm has the registration of another strength of Docetaxel Injection 120mg/6mL
along with the diluent 9mL (Reg. No. 092154) approved in 275th meeting.
• The composition of diluent is as per the product approved by TGA Australia.
Label claim:
Docetaxel……..20mg
Composition of diluent:
Ethanol absolute……0.2379mL
Water for injection….1.83mL (q.s)
Decision: The Board deliberated that the applied product is in combo pack and the
diluent will be manufactured by the manufacturer, therefore the Board approved the
case and decided that the applicant will submit full fee that is Rs. 30,000/- for revision of
composition of diluent as per reference product before issuance of registration letter.
47. 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 + Gemnil 1g Injection
Strength Lyophilized Powder for Injection
Diary No. Date of R& I & fee Dy.No. 5588 dated: 07/02/2019 Rs.20,000/-
Composition Each Vial Contains:
Gemcitabine as HCL…..…1gm
Pharmacological Group Antineoplastic
Type of Form Form 5
Pack Size & Demanded Price 1’s (26.3mL), Price as per SRO

Approval Status of Product in GEMZAR (gemcitabine) for injection, Lyophilized
Reference powder (200mg/via & 1gm/vial) by M/s Lilly USA,
Regulatory Authorities LLC, USFDA Approved.
Me-too Status ONCOGEM 1gm injection by M/s AJ MIRZA
PHARMA (PVT) LTD., (Imported) Reg. No. 45672
GMP Status Following additional sections were approved vide
letter No.F.1-53/2003-Lic.(Vol-I) dated 13th June,
2017.
• Tablet (oncology)
• Capsule (oncology)
• Liquid vial SVP (oncology)
• Liquid Ampoule SVP (Onclology)
• Dry powder vial (oncology)
• Capsule (Ceph)
• Dry [powder for oral suspension (ceph)
• Dry Powder vial (ceph)
• Dry Powder vial (Ceph)
Remarks of the Evaluator. Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along
with registration number, brand name and name of
firm with same strength and filled volume could not
be confirmed.
Decision: Decision of 293rd meeting:
Deferred for confirmation of manufacturing method (powder filling or lyophilization) and
requisite facility.
• The applicant has stated that they had applied for Gemnil 1g & 200mg liquid injection
but these products were deferred in 293rd meeting for confirmation of manufacturing
facility.
• Furthermore, as per the response of the firm, the product will be manufactured in
approved Liquid vial SVP Oncology section.
• The firm has submitted full fee Rs. 30,000/- vide challan number 17153518278 dated
03/08/2022 along with the duplicate dossiers..
• Copy of GMP certificate No. F.3-55/2020-Addl.Dir.(QA&LT-1) issued on the basis
of inspection conducted on12/08/2020.
Label Claim:
Gemcitabine as HCl…….1g
Reference:
1. Gemcitabine IV Infusion 1 g/ 26.3 mL (solution for infusion) Hospira, TGA Australia
approved
2. Gemcitabine Ebewe 80mg Injection By M/s Novartis Reg. no. 66183
Decision: The Board discussed that the applied formualtion is approved in reference
regualtory authorities as Lyophilised Powder for Injeciton as well as Solution for
Injection and the firm has requested the change of dosage form of the applied
formualtuion from Lyophilised Powder for Injeciton to Solution for Injection. Keeping
in view, the Board deferred the case for furhter clarification of the applied dosage form
from the firm.
48. 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 + Gemnil 200mg Injection
Strength Powder for Injection
Diary No. Date of R& I & fee Dy.No. 5600 dated: 07/02/2019 Rs.20,000/-

Gemcitabine as HCL…..…200mg
Pharmacological Group Antineoplastic
Type of Form Form 5
Pack Size & Demanded Price 1’s, Price as per SRO
Approval Status of Product in GEMZAR (gemcitabine) for injection, Lyophilized
Reference powder (200mg/via & 1gm/vial) by M/s Lilly USA,
Regulatory Authorities LLC, USFDA Approved.
Me-too Status ONCOGEM 200mg injection by M/s AJ MIRZA
PHARMA (PVT) LTD., (Imported) Reg. No. 45671
GMP Status Following additional sections were approved vide
letter No.F.1-53/2003-Lic.(Vol-I) dated 13th June,
2017.
• Tablet (oncology)
• Capsule (oncology)
• Liquid vial SVP (oncology)
• Liquid Ampoule SVP (Onclology)
• Dry powder vial (oncology)
• Capsule (Ceph)
• Dry [powder for oral suspension (ceph)
• Dry Powder vial (ceph)
• Dry Powder vial (Ceph)
Remarks of the Evaluator.
Decision: Decision of 293rd meeting:
Deferred for confirmation of manufacturing method (powder filling or lyophilization) and
requisite facility.
• The applicant has stated that they had applied for Gemnil 1g & 200mg liquid injection
but these products were deferred in 293rd meeting for confirmation of manufacturing
facility.
• Furthermore, as per the response of the firm, the product will be manufactured in
approved Liquid vial SVP Oncology section.
• The firm has submitted full fee Rs. 30,000/- vide challan number 17153518278 dated
03/08/2022 along with the duplicate dossiers.
Label Claim:
Gemcitabine as HCl…….200mg
Reference:
1. Gemcitabine IV Infusion 200 mg/ 5.3 mL Hospira, TGA Australia approved.
2. Gemcitabine Ebewe 200mg Injection By M/s Novartis Reg. no. 66182
Decision: The Board discussed that the applied formualtion is approved in reference
regualtory authorities as Lyophilised Powder for Injeciton as well as Solution for
Injection and the firm has requested the change of dosage form of the applied
formualtuion from Lyophilised Powder for Injeciton to Solution for Injection. Keeping
in view, the Board deferred the case for furhter clarification of the applied dosage form
from the firm.
Brand Name +Dosage Form + Rubidox P 50mg/25ml Injection
Strength

Composition Each ml contains:
Doxorubicin hydrochloride…2mg
(as liposomal pegylated)
Pharmacological Group Anthracyclines and related substances
Type of Form Form-5
Pack Size & Demanded Price 1’s(25ml): As per SRO
Approval Status of Product in USFDA (Doxil Liposomal)
Reference
Regulatory Authorities
Me-too Status Nagun 50 Injection of M/s. Ghani Brothers
registered in import (Reg. no. 072574)
concluded
• Packaging material not mentioned submit separate
performing terminal
applied formulation
whether it is type I, II, or III glass container..
Response of the Firm • Firm informed that they import ready to fill sterile
bulk solution for infusion.
• Firm submitted that filling of product done under
aseptic condition and prior to filling solution has
been filtered for sterilization.
• Primary packaging material is Glass vial Type-I.
will be self manufactured. In case of self manufacturing of diluent by M/s Rotex Pharma Pvt
Ltd., firm shall submit manufacturing process along with detail of manufacturing area in which
the diluent will be manufactured.
• The firm has stated that no diluent is applied and there is no requirement for any diluent
as well.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050718Orig1s060lbl.pdf
(Accessed on 21/07/2022 at 1:50pm).
Decision: The Board was apprised that the applied product is in liposomal dispersion
and the liposomal carriers used in the applied formulation have a complex composition
and also product is pegylated. The Board after deliberation regarding complexity of
manufacturing method decided to defer the case for detail of manufacturing technique
and facility including the detail of equipments used in the manufacturing of the applied
product.
Brand Name +Dosage Form + Neoplaxol 100mg/5ml Injection
Strength
Diary No. Date of R& I & fee Dy.No 5592 dated 07-02-2019 Rs.20,000/-
Composition Each 5ml ampoule contains:
Etoposide as phospate…100mg
Pharmacological Group PLANT ALKALOIDS AND OTHER NATURAL
PRODUCTS
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 1’s (5ml):As per SRO
Approval Status of Product in Approved in TGA
Reference
Me-too Status SEDOL 100MG/5ML INJECTION of Helix
concluded
Packaging material not mentioned
Previous Decision of Registration Submit justification on scientific grounds for not
Board (M-296) performing terminal sterilization of applied
formulation.
Mention type of primary packaging material of
applied formulation whether it is type I, II, or III
glass container.
• The firm has stated that Etoposide API is found to undergo a dehydration reaction in
the temperature range of 850C to 1150C which forms new polyform, hence sterilization
process performed by filtration under aseptic manufacturing conditions.
• Primary packaging material is Glass Ampoule (Type I).
• Copy of GMP certificate No. F.3-55/2020-Addl.Dir.(QA&LT-1) issued on the basis
of inspection conducted on12/08/2020.
Decision: Approved.
Brand Name +Dosage Form + Irotec 300mg Injection
Strength
Diary No. Date of R& I & fee Dy.No 5587 dated 07-02-2019 Rs.20,000/-
Irinotecan Hcl Trihydrate…20mg
Pharmacological Group Other antineoplastic agents
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 1’s (15ml):As per SRO
Approval Status of Product in Approved in USFDA
Reference
Me-too Status IRINOTECAN EBEWE 100MG/5ML of Novartis
concluded
Packaging material not mentioned
Previous Decision of Registration Board (M-296)
Submit justification on scientific grounds for not performing terminal sterilization of
applied formulation.
Mention type of primary packaging material of applied formulation whether it is type I, II,
or III glass container.
Response of the Firm

• The firm has submitted revised method of manufacturing with the details of terminal
sterilization.
• Primary packaging material is Type I glass vial.
issued after submission of pre-registration variation fee that is Rs. 30,000/- for revision
of manufacturing method as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
52. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No. 224,
Applicant Sector-23, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Ezesel 10mg+10mg Tablet
Strength
Diary No. Date of R& I & fee Diary No:15805, 21/09/2017, Rs: 20,000/-
Composition Each film coated tablet contains:
Atorvastatin …10mg
Ezetimibe …10mg
Pharmacological Group HMG CoA reductase inhibitors in combination
with other lipid modifying agents
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack Size & Demanded Price 10’s, 14’s, 28’s / As per SRO
Approval Status of Product in ATOZET 10 mg/10 mg, film-coated tablets by M/s
Reference TEVA UK Limited (MHRA approved)
Me-too Status Zetab Plus Tablet by M/s Schazoo Laboratories
(Reg#046244)
GMP Status Last GMP inspection conducted on 19-07-2017 and
the report concludes good level of GMP compliance.
Remarks of the Evaluator. Firm has applied as Atorvastatin base while
approved formulation in MHRA has Atorvastatin
(as calcium trihydrate).
Deferred for submission of fee for revision of formulation
• The firm has revised the formulation (Salt form Correction: Atorvastatin as Calcium
Trihydrate). The firm has submitted Rs. 7500/- vide challan No. 139609523267 dated
13/04/2022 while full fee is required for revision of formulation.
• The revised label claim is:
Each film coated tablet contains:
Atorvastatin as Calcium Trihydtrate …10mg
Ezetimibe …10mg
• Initially the firm has applied for Atorvastatin base.
• The Gmp inspection is conducted on 12December, 2021 is based on evaluation
conducted on 30th June, 2021.
issued after submission of differential fee that is Rs. 22,500/- for revision of formulation
as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Spadix 80mg+80mg Tablet
Strength
Composition Each tablet contains:

Phloroglucinol hydrate …80mg
Trimethylphloroglucinol …80mg
Pharmacological Group Other drugs for functional gastrointestinal disorders
Type of Form Form-5
Pack Size & Demanded Price 10’s, 14’s, 30’s / As per SRO
Approval Status of Product in SPASFON, coated tablet by M/s Teva Health
Reference (ANSM approved.)
Me-too Status Anafortan Plus Tablet by M/s AGP Pharma
(Reg#024504)
Remarks of the Evaluator. Firm has applied as plain tablet whereas reference
product is approved as sugar coated tablet.
Deferred for submission of fee for revision of formulation
The firm has revised the formulation from plain tablet to Sugar coated Tablet and submitted
Rs. 7500/- vide challan No. 3443003125 dated 09/05/2022 for revision of formulation.
The revised label claim is:
Each sugar coated tablet contains:
Phloroglucinol hydrate …80mg
Trimethylphloroglucinol …80mg
The Gmp inspection is conducted on 12th December, 2021 is based on evaluation conducted
on 30th june, 2021.
Brand Name +Dosage Form + Co-Mesart 20mg+10mg Tablet
Strength
Composition Each film-coated tablet contains:
Olmesartan medoxomil …20mg
Amlodipine as besilate …10mg
Pharmacological Group Angiotensin II antagonists and calcium channel
blockers
Type of Form Form-5
Pack Size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s / As per SRO
Approval Status of Product in Not confirmed
Reference
Me-too Status Comcarb 10/20mg tablet by M/s Maple
Pharmaceuticals (Pvt) Ltd (Reg#061883)
Remarks of the Evaluator. Firm has applied as Atorvastatin base while
approved formulation in MHRA has Atorvastatin
(as calcium trihydrate).
th

Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
The firm has submitted following reference which has been verified through online data base.
• Olmesart amlodipine by Arrotex Pharamceuticals.
(Olmesartan medoxomil……20mg
Amlodipine as besilate…….. 10mg)
• TGA Australia Approved
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=2
90091&agid=(PrintDetailsPublic)&actionid=1 (Accessed on 21/07/2022 at 2:44pm)
The Gmp inspection is conducted on 12December, 2021 is based on evaluation conducted on
30th june, 2021.
Decision: Approved.
55. Name and address of manufacturer / M/s ZAFA Pharmaceutical Laboratories (Private)
Applicant Limited L1/B Block-22 Federal B Industrial Area,
Karachi
Brand Name +Dosage Form + Trimezat Tablet 100mg
Strength
Diary No. Date of R& I & fee Dy No. : 21.05.2011
PKR 8,000/-: 21.05.2011 (Duplicate Dossier)
Dy.No. 1209 PKR 12,000/- (slip No. 0730281)
09.01.2019
Trimebutine maleate…….100mg
Pharmacological Group Synthetic anticholinergics, esters with tertiary
amino group
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer’s specifications
Pack Size & Demanded Price 2 x10’s; Rs. 131.45
10 x 10’s; Rs. 657.25
Approval Status of Product in Debricalm 100mg film-coated tablets. ANSM
Reference approved
Me-too Status Tribate Tablets. Reg. No. 20257
GMP Status GMP certificate dated 25/08/2022 issued on the
Tablet general section approved vide letter no. F.2-
11/2002-Lic(Vol-I) dated 26/05/2022.
Remarks of the Evaluator. The firm was asked for complete finished product
specifications; however, the firm submitted
incomplete
specifications.
th
Consideration on its turn.
The firm has submitted complete specifications for the applied product along with the testing
method.
Inspection report is older than 3 years (GMP certificate issue don 23/05/2018)
Decision: Approved with innovator’s specifications.
• Registration Board further decided that registration letter will be issued after
submission of fee that is Rs. 7,500/- for revision of for revision of specifications as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021

56. Name and address of manufacturer / M/s Welwrd Pharmaceuticals, Plot # 3, Block_A,
Applicant Phase I-II, Hattar Industrial Estate, Hattar
Brand Name +Dosage Form + Thiowalt Capsule 4mg
Strength
Diary No. Date of R& I & fee Dy No. 22958: 04.12.2017 PKR 20,000/-:
28.11.2017
Composition Each capsule contains:
Thiocolchicoside…….4mg
Pharmacological Group Other centrally acting agents
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer’s specifications
Pack Size & Demanded Price 1x10’s; as per policy
Approval Status of Product in MIOREL 4 mg capsule. ANSM approved
Reference
Me-too Status Muscucoside capsule 4mg. Reg. No. 81656
GMP Status Inspection was conducted on 12.11.2018, wherein
the following sections of the firm were considered
to be operating at satisfactory level of GMP.
i) Tablet Section (General/antibiotics)
ii) Liquid injectable section (General/antibiotics)
iii) Dry injectable section (General/antibiotics)
iv) Dry powder injectable (cephalosporins)
While the remaining sections viz Capsule general,
dry powder suspension general and Sachet sections
were observed with certain shortcomings that need
to be rectified.
Deferred for updated status of GMP of the firm form QA & LT division as inspection report
submitted by firm does not recommend GMP compliant status for capsule general section.
The firm has submitted copy of GMP Certificate No. F.11-76/2022-DRAP-69 issued on
10/06/2022 valid till 30/03/2022.
that registration letter will be issued after submission of fee that is Rs. 7,500/- for revision
57. Name and address of manufacturer / M/s Fedro Pharmaceuticals Lab Pvt Limited. 149-
Applicant Industrial Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Fexofed 180mg Tablets
Strength
Diary No. Date of R& I & fee Dy.No 26057 dated 27-12-2017
Rs. 20,000 Dated 27-12-2017
Composition Each Tablet Contains:
Fexofenadine HCL…180mg
Pharmacological Group NSADI
Type of Form Form 5
Pack Size & Demanded Price 1x 10’s, 20’s As per SRO
Approval Status of Product in Fexofenadine hydrochloride tablets by Mylan
Reference (USFDA Approved) Approved as Film coated
Regulatory Authorities tablet
Me-too Status Fenadex 180mg tablet of M/s Global
Pharmaceuticals (Reg. #031139)

GMP Status 3-3-2017 Panel recommends the renewal of DML.
Remarks of the Evaluator. Internationally approved product is film coated
tablet.
Deferred for revision of formulation as per reference product along with submission of
requisite fee for change of formulation.
• The firm has revised the formulation from uncoated to film coated tablet and
submitted Rs. 7500/- vide challan number 37219921503 dated 21/07/2022.
• Copy of GMP certificate No.F.11-12/2022-DRAP-39 issued on the basis of inspection
conducted on 03/02/2022.
Decision: Approved.
58. Name and address of manufacturer / M/s Fedro Pharmaceuticals Lab Pvt Limited. 149-
Brand Name +Dosage Form + Fexofed 180mg Tablets
Strength
Diary No. Date of R& I & fee Dy.No 26060 dated 27-12-2017
Rs. 20,000 Dated 27-12-2017
Fexofenadine HCL…120mg
Pharmacological Group NSADI
Type of Form Form 5
Pack Size & Demanded Price 1x 10’s, 20’s As per SRO
Approval Status of Product in Fexofenadine hydrochloride tablets by (MHRA
Reference Approved)
Me-too Status Epodin 120mg Tablet M/s Epoch Pharmaceutical,
GMP Status 3-3-2017 Panel recommends the renewal of DML.
Remarks of the Evaluator. Internationally approved product is film coated
tablet.
th
Deferred for revision of formulation as per reference product along with submission of
requisite fee for change of formulation.
• The firm has revised the formulation from uncoated to film coated tablet and
submitted Rs. 7500/- vide challan number 52136851387 dated 21/07/2022.
• Copy of GMP certificate No.F.11-12/2022-DRAP-39 issued on the basis of inspection
conducted on 03/02/2022.
Decision: Approved.
59. Name and address of manufacturer / M/s Fedro Pharmaceutical labs. (Pvt) Ltd., 149-
Brand Name +Dosage Form + FE-ZOLE 2.5mg Tablet
Strength
Diary No. Date of R& I & fee 17901, 15-05-2018, 20,000/-, 11-05-2018
Letrozole……………….2.5mg
Pharmacological Group Aromatase inhibitor
Type of Form Form 5
Finished Product Specification In-House
Pack Size & Demanded Price 10’s; As per SRO
Approval Status of Product in FEMARA 2.5 mg Tablet by M/s Novartis Pharma
Reference (USFDA approved)

Me-too Status Aromek 2.5mg Tablet by M/s Glaxy
Pharmaceuticals (Reg#052258)
GMP Status Panel inspection dated 03-03-2017 recommends for
renewal of DML.
Registration Board referred the case to QA & LT Division to conduct GMP inspection of Firm
on priority.
The firm has submitted copy of GMP Certificate No. F.11-12/2022-DRAP-39 issued on
28/04/2022 valid till 03/02/2022.
Decision: Registration Board approved registration of product with USP specifications
in general manufacturing areas with condition that manufacturer shall provide safety
and protective measures for workers and personnel which remain in direct contact or
are involved in close handling of these drugs. Furthermore, the registration letter will be
issued after submission of fee that is Rs. 7,500/- for revision of specifications as per
60. Name and address of manufacturer / M/s Akson Pharmaceuticals Private limited,
Applicant Plot # 9-B/1&2, old Industrial Estate, Sector
D1,Mirpur, Azad Kashmir.
Brand Name +Dosage Form + Sulosin 0.2mg capsule
Strength
Diary No. Date of R& I & fee Dy. No. 41634 dated 07/12/2018 Fee Rs. 20,000/-
Tamsulosin HCl (pellets SR 0.2%)………..0.2mg
Pellets
Source of pellets: M/s Vision Pharma
Pharmacological Group Alph adrenergic antagonist
Type of Form Form 5
Pack Size & Demanded Price 10’s, 30’s, 50’s, price as per SRO
Approval Status of Product in Could not be confirmed
Reference
Me-too Status Harnal 0.2mg Capsules by M/s Hilton Pharma, Reg
No. 45084
GMP Status Last inspection report dated 16/06/2017 and
25/07/2017, the panel recommended the renewal of
license by the way of formulation.
Remarks of the Evaluator. The firm has revised the formulation from Enteric
Coated pellets to Sustained Released pellets as per
the reference product with submission of fee Rs.
5000/- vide challan number 1983152 dated
30/03/2020.
Deferred for submission of remaining fee.
The firm has submitted Rs. 15,000/- fee for revision of formulation vide challan No.
94421040 dated 23/12/2021.
Last inspection report dated 22/02/2019 concludes “Keeping in view the above stated facts
based upon the areas visited, records reviewed and people met, it may be concluded that the
management has rectified almost all the observations from previous inspection and as of today
the firm’s facility is suitable to carry out manufacturing and testing of pharmaceuticals. As ,
the GMP is a continual process of improvement, hence updating the procedures shall always

remain a task, the management is advised to develop a forward thinking progressive
environment, adapting the recent trends”.
Routine Cases (Veterinary):

61. Name and address of manufacturer / M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Super Dox 80 Powder
Strength
Diary No. Date of R& I & fee Dy.No 1161: 09-01-2019 Rs. 20,000/-: 04-01-2019
Composition Each 1000gram contains:
Doxycycline as hyclate…800g
Type of Form Form 5
Finished Product Specification Innovator’s
Pack Size & Demanded Price As per SRO
Me-too Status Could not be confirmed
GMP Status Inspection report: 18 & 23.04.2019 concludes that:
Based on the areas inspected, the people met and the
documents reviewed, and considering the findings
of the inspection M/s Bio Labs Pvt Ltd was
considered to be operating at a reasonably
acceptable compliance with GMP as of today as per
the Drugs Act, 1976 and Drap, Act, 2012 and rules
framed there under.
Remarks of the Evaluatorix Form 5 has been signed by the quality control
manager.
Provide proof of me-too product (name and
registration number) having same strength and salt
form already approved by DRAP.
Previous decision The board in its 295th meeting deferred the case for
confirmation of me-too product.
Evaluation by PEC Reply dated 02.08.2021:
The firm submitted signed Form 5.
The firm provided the following me too:
Doxyral 80% water soluble powder Reg. No.
082504
The firm has not adjusted the weight of API in
master formula as per salt factor.
Deferred for adjustment of the weight of API in master formula as per salt factor along with
submission of applicable fee.
The firm has adjusted the weight of API in accordance with the salt factor and has submitted
the revised master formula along with the fee of Rs. 30,000/- vide challan number 3243123802
dated 14/06/2022.
Decision: Approved.
62. Name and address of manufacturer / M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Bio-Cosul 50 WSP
Strength
Diary No. Date of R& I & fee Dy. No 5561: 08-05-2019 Rs. 20,000/-: 08-05-2019

Composition Each Gram Powder Contains:
Colistin sulphate…50 MIU
Pharmacological Group cationic polypeptide antibiotic
Type of Form Form 5

Finished Product Specification Innovator’s
Me-too Status Could not be confirmed
GMP Status Inspection report: 18 & 23.04.2019 concludes that:
Based on the areas inspected, the people met and the
documents reviewed, and considering the findings
of the inspection M/s Bio Labs Pvt Ltd was
considered to be operating at a reasonably
acceptable compliance with GMP as of today as per
the Drugs Act, 1976 and Drap, Act, 2012 and rules
framed there under.
Remarks of the Evaluatorix Form 5 has been signed by the quality control
manager.
Provide proof of me-too product (name and
registration number) having same strength and salt
form already approved by DRAP.
Previous decision The board in its 295th meeting deferred the case for
confirmation of me-too product.
The firm submitted signed Form 5.
Now, the firm has claimed in-house specifications
without submission of details.
The firm provided the following me too:
COLISTIN WATER SOLUBLE POWDER Reg.
No. 071022 with the label claim: EACH 100GM
CONTAINS:-
COLISTIN SULPHATE..5,000,000 IU, which is
not in line with the applied product.
Deferred for confirmation of generic status.
The firm has revised the label claim in-lined with the me-too product.
Each 100gm Contains:
Colistin Sulphate……….5,000,000 IU.
issued after submission of full fee that is Rs. 30,000/- for revision of formulation
according to me-too product as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
Agenda of Evaluator PEC-II

Case no. 01 New Registration applications on Form 5F (Human)
New Cases (Human)
63. Name, address of Applicant / Marketing M/s English Pharmaceuticals Industries.
Authorization Holder Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore

Name, address of Manufacturing site. M/s English Pharmaceuticals Industries.
Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Coliate 4.5MIU Injection
Pharmaceutical ingredient (API) per unit Colistimethate sodium …….. 4.5MIU
Pharmaceutical form of applied drug Dry powder injection
Reference to Finished product specifications USP
The status in reference regulatory authorities Approved by MHRA of UK
For generic drugs (me-too status) Colicraft 2MIU Lypholized powder for
solution for injection Reg.# 094751
GMP status of the Finished product GMP certificate issued on the basis of
manufacturer inspection conducted on 17& 18-01-2019
Evidence of manufacturing facility. GMP certificate issued on the basis of
inspection conducted on 17& 18-01-2019,
declares availability of Dry powder injectable
section.
Name and address of API manufacturer. M/s Hebei Shengxue Dacheng Pharmaceutical
Co., Ltd., China
submitted.

substance
months
months
procedure and its verification studies, batch
and stability studies of drug product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been
dissolution profile established against the Colixiin Injection of
Pharmis Biofarmaceutica, Lda.
Analytical method validation/verification of --
product
Manufacturer of API M/s Hebei Shengxue Dacheng Pharmaceutical Co., Ltd., No. 50 Shengxue
Road, Luancheng, Shijiazhuang, China
API Lot No. HN180401
Description of Pack
(Container closure Amber glass vial
system)
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Months)
Batch No. Trial-005 Trial-006
Batch Size 2700 packs 2700 packs
Manufacturing Date 06-2020 06-2020
No. of Batches 03
1. Reference of previous approval of applications N/A
with stability study data of the firm (if any)
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No.HE20190058
manufacturer issued by concerned regulatory issued by NMPA China valid till 14/08/2024.

3. Documents for the procurement of API with • Firm has submitted copy of commercial
approval from DRAP (in case of import). invoice no. TM20181106 attested by AD
DRAP I&E Lahore dated 19-11-2018 for the
import of 8Kg Colistimethate sodium.
4. Data of stability batches will be supported by Submitted
attested respective documents like
chromatograms,
Raw data sheets, COA, summary data sheets etc.
5. Compliance Record of HPLC software 21CFR & N/A
audit trail reports on product testing
6. Record of Digital data logger for temperature and Submitted
humidity monitoring of stability chambers (real

1.1 Submitted covering letter & fee slip mentins the Firm has submitted an “Afffidavit”
strength as 4MIU whereas the dossier reflects stating that “Ms English
4.5MIU strength. Clarifcation shall be Pharmaceutical do hereby
submittein this regard. undertake that we have submitted
fee challan# 6195143544 dated
17th Spetember 2021, for Coliate
4.5MIU injection bu due to
typographical mistake we have
written 4MIu instead of 4.5MIU in
fee challan & covering letter of
said product, we undertake that we
will not use dthis fee challan in any
other product further.
3.2.S.4.4 Submitted COA of drug substance from M/s Firm has submitted revise COA of
English Pharma declares Assay limit in terms of drug substance declaring Assay
%age instead of mcg/mg or IU/mg. results both in terms of mcg/mg &
Clarification shall be submitted in this regard %age.
3.2.S.4.5 Clarification shall be submitted whether drug Specifications by drug substance
specifications are as per BP or USP monograph. manufacturer & drug product
manufacturer are as per USP
monograph as confirmed by the
COA and test methods.
3.2.P.1 Provide information including type of diluent, 2 ml sterile water for injection
its composition, quantity or volume, which is to filled in glass ampoule is
be provided along with the applied drug. accompanying reconstitution
diluent.
3.2.P.2.6 Compatibility studies for the dry powder for Firm has submitted results of
injections shall be submitted as per the compatibility study with 2ml
instructions provided in individual label of the sterile water for uinjection with
drug product. performance of tests of Clarity of
solution, pH & Assay.
3.2.P.5.2 • Analytical method has been submitted for • As idenitifed by your good
Coliate 1MIU injection instead of the office,there was a typo error in
applied strength of 4.5 MIU injection. the method drafting , and test
• Clarification shall be submitted regarding method of 4.5MIU injection is
incubation time for the performance of now submitted.
Assay test. Incubation time for assay
performance is 24 hours or until

growth is apparent at 32oC to 35
o
C.
3.2.P.8 Submitted raw data sheets are not readable. Firm has submitted new set of
Submit readable copies of the raw data sheets of prints for the raw data sheets.
the stability studies.
throughout proposed shelf life and on accelerated studies for six months as per the commitment
64. Name, address of Applicant / Marketing M/s English Pharmaceuticals Industries.
Authorization Holder Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore
Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Coliate 2MIU Injection
Pharmaceutical ingredient (API) per unit Colistimethate sodium …….. 2MIU
Pharmaceutical form of applied drug Dry powder injection
The status in reference regulatory authorities Approved by MHRA of UK
For generic drugs (me-too status) Colicraft 2miu Lypholized powder for solution
for injection Reg.# 094751
GMP status of the Finished product GMP certificate issued on the basis of
manufacturer inspection conducted on 17& 18-01-2019
Evidence of manufacturing facility. GMP certificate issued on the basis of
inspection conducted on 17& 18-01-2019,
declares availability of Dry powder injectable
section.

Name and address of API manufacturer. M/s Hebei Shengxue Dacheng Pharmaceutical
Co., Ltd., China
submitted.
substance
months
months
dissolution profile established against the Colixiin Injection of
Pharmis Biofarmaceutica, Lda.
Analytical method validation/verification of --
product
Manufacturer of API M/s Hebei Shengxue Dacheng Pharmaceutical Co., Ltd., No. 50 Shengxue
Road, Luancheng, Shijiazhuang, China
Description of Pack
(Container closure Amber glass vial
system)

Frequency Accelerated: 0,1,3,6 (Months)
Real Time: 0,1,3,6 (Months)
Batch No. T-001 T-002
Batch Size 2700 packs 2700 packs
No. of Batches 03
1. Reference of previous approval of applications N/A
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No.HE20190058
manufacturer issued by concerned regulatory issued by NMPA China valid till 14/08/2024.
3. Documents for the procurement of API with • Firm has submitted copy of commercial
approval from DRAP (in case of import). invoice no. TM20181106 attested by AD
DRAP I&E Lahore dated 19-11-2018 for the
import of 8Kg Colistimethate sodium.
chromatograms,
5. Compliance Record of HPLC software 21CFR & N/A

3.2.S.4.4 Submitted COA of drug substance from M/s Firm has submitted revise
English Pharma declares Assay limit in terms of COA of drug substance
%age instead of mcg/mg or IU/mg. declaring Assay results both
Clarification shall be submitted in this regard in terms of mcg/mg & %age.
3.2.S.4.5 Clarification shall be submitted whether drug Specifications by drug
specifications are as per BP or USP monograph. substance manufacturer &
drug product manufacturer
are as per USP monograph
as confirmed by the COA
and test methods.
3.2.P.1 Provide information including type of diluent, 2 ml sterile water for
its composition, quantity or volume, which is to injection filled in glass
be provided along with the applied drug. ampoule is accompanying
reconstitution diluent.
3.2.P.2.6 Compatibility studies for the dry powder for Fir mhas submitted results of
injections shall be submitted as per the compatibility study with 2ml
instructions provided in individual label of the sterile water for uinjection
drug product. with performance of tests of
Clarity of solution, pH &
Assay.
3.2.P.5.2 • Analytical method has been submitted • As idenitifed by your
for Coliate 1MIU injection instead of good office,there
the applied strength of 2 MIU injection. was a typo error in

• Clarification shall be submitted the method drafting ,
regarding incubation time for the and test method of
performance of Assay test. 2MIU injection is
now submitted.
• Incubation time for
assay performance is
24 hours or until
growth is apparent at
32oC to 35 oC.
65. Name, address of Applicant / Marketing M/s SAMI Pharmaceuticals (Pvt) Ltd. F-95, Off
Authorization Holder Hub River Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s SAMI Pharmaceuticals (Pvt) Ltd. F-95, Off Hub
River Road, S.I.T.E. Karachi.
☐ Importer
☐Generic Drug Product (GDP)
☐ Export sale
PKR 45,000/-: dated 25/10/2021
The proposed proprietary name / brand Provas Advance 500mg Tablet
name
Alternate brand name: PROVAS NOVO 500mg
Tablets
Active Pharmaceutical ingredient (API) Paracetamol ………. 500mg
per unit
Pharmaceutical form of applied drug White to off-white colored capsular shaped film coated
tablet, break line on one side and other side is plain
Pharmacotherapeutic Group of (API) NSAID
ATC Code: N02BE01
USP
specifications
Proposed Pack size 10’s, 20’s, 30’s, 50’s & 100’s
The status in reference regulatory Panadol Advance 500mg Tablet, M/s. GSK, approved
authorities by MHRA of UK

For generic drugs (me-too status) Not applicable
GMP status of the Finished product GMP certificate issued dated: 11-08-2020
manufacturer
Name and address of API manufacturer. Name: HEBEI JIHENG (GROUP)
PHARMACEUTICAL CO., LTD SHENZHOU
PLANT
(shortened as Jiheng Shenzhou)
Address: Southeast Xijingming Village
Donganzhuang Township, Shenzhou County Henshui
City, Hebei Province, CHINA
characterization, impurities, specifications, analytical
procedures and its verification, batch analysis and
Module III (Drug Substance) The firm has submitted details of nomenclature,
structure, general properties, solubility, physical form,
and controls, tests for impurity J, K, F, individual
impurity and total impurity, specifications, analytical
justification of specification, working standard,
substance.
Real time: 30°C ± 2°C / 75% ± 5%RH for 60 Months
impurities, specifications, analytical procedure and its
system and stability studies of drug product.
comparative dissolution profile against the brand leader that is PANADOL
ADVANCE 500mg tablet by M/s. GSK.
CDP has been performed against the same brand that
is PANADOL ADVANCE 500mg tablet by M/s.
GSK in Acid media (pH 1.2-4.5) & Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the
acceptable range.
Analytical method validation/verification Method verification studies have been submitted
of product including Linearity, Accuracy & Precision including
Repeatability & Specificity.
Manufacturer of API HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD SHENZHOU
PLANT, CHINA

API Lot No. 31709016
Description of Pack
(Container closure Alu/PVC Blister
system)
Batch Size 2000 Tablets 2000 Tablets 2000 Tablets
No. of Batches 03
1. Reference of previous approval of The firm has submitted reference of last onsite panel
applications with stability study data of inspection for instant dosage form conducted during
the firm (if any) last two years i.e. EMPOLI (Empagliflozin) 10mg &
25mg Tablets which was presented in 290th meeting of
the registration board & hence approved & registered
by registration board Date of inspection: 13th June
2019. The inspection report confirms following points
• The HPLC software is 21CFR Compliant.
• Adequate monitoring and control are available for
stability chamber. Chambers are controlled and
monitored through software having alarm system for
alerts as well.
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. HE20180054 issued by
of API manufacturer issued by concerned Hebei CHINA FOOD AND DRUG
regulatory authority of country of origin. ADMINISTRATION valid till 08/07/2023
3. Documents for the procurement of API Copy of commercial invoice (Invoice# 1708ZP03
with approval from DRAP (in case of dated 19th October 2017 with received quantity i.e.
import). 5000 kgs) for the purchase of Paracetamol from M/s
Hebei Jiheng Shenzhou Pharmaceutical Co., Ltd.
China with attestation of DRAP dated 01‐11‐2017
4. Data of stability batches will be supported Firm has submitted complete record of testing of all
by attested respective documents like batches along with chromatograms, raw data sheets,
chromatograms, Raw data sheets, COA, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail record of product testing
21CFR & audit trail reports on product of HPLC for all test intervals.
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time and
stability chambers (real time and accelerated stability chambers.
accelerated)

• Regarding justification of specifications of drug product, firm has submitted as under:
“The dissolution parameters and testing procedure is as per USP Pharmacopeia but as the
Paracetamol is rapidly dissolving drug and falls in BCS Class I, we stringent the dissolution
specifications from 30 minutes to 10 minutes
The selection of specified time for Dissolution is based on the BCS classification of API, as the
drug is independent over physiological pH range (i-e from 1.2 to 6.8) and ·as per USP General
chapter <1092>, the dissolution of rapidly dissolving product is achieved within 15 minutes
therefore we established our dissolution time within 10minutes.”
• Firm has submitted following comparison between the applied formulation and conventional
paracetamol tablet already available in market:
Parameters PROVAS Novo 500mg Tablet Paracetamol 500mg Tablet

Dosage Form Tablet Tablet
Immediate release uncoated
Dosage Design Immediate release film coated tablet
tablet
Route of Oral Oral
Administration
Dosage Strength 500mg 500mg
Pharmacokinetics The special technology allows PROVAS Paracetamol is readily
Novo 500mg Tablet to begin dissolving absorbed from the
in 5 minutes and start to relieve pain gastrointestinal tract with
within 15 minutes peak plasma concentrations
occurring about 30 minutes to
2 hours after ingestion
Patient’s • Capsular shape makes it easy to swallow • Round shape makes it
Acceptance & • Bitter taste of Paracetamol is masked difficult to swallow
Compliance through film coating • Bitter Taste
• Quick & Effective Pain Relief Delayed Pain Relief
Stomach Friendly
Technology Used PROVAS Novo 500mg Tablet is a Paracetamol 500mg Tablet
Paracetamol formulation that contains an formulated using a
advance technology to rapid the onset of conventional wet granulation
action process
Key Features • It has unique delivery system as Onset of action is slow, as
PROVAS Novo 500mg Tablet is a peak plasma concentrations
Paracetamol formulation that contains occurring about 30 minutes to
a rapid dispersion and dissolution 2 hours after ingestion
technology which breakdown
Paracetamol tablets in the stomach so
that the drug is absorbed fast and pain
relief can start within 15 minutes after
ingestion
• The technology contains three main
ingredients viz.:
o Alginic Acid draws fluid from the
stomach into the tablet causing it to
swell and break apart
o Calcium Carbonate works together
with Alginic Acid to boost
disintegration of the tablet

o Crospovidone acts as a super-
disintegrant due to its ability to
dissolve well in water
• The absorption of Paracetamol occurs
in the small intestine and as such is
dependent on the rate of emptying of
stomach contents into the small
intestine and is therefore not
associated with gastric irritation. The
technology used in PROVAS Novo
500 mg Tablet increases gastric
emptying time of the drug.
• PROVAS Novo 500mg Tablet with
this advance technology disperses up
to five times faster than standard
paracetamol tablets
Suitable for all such patients requiring
low sodium content in their diet

3.2.P.5.1 • Limits for disintegration We set disintegration specification according to
test i.e., NMT 30 minutes USP general monograph for Disintegration
are inconsistent with the <701> which specifies NMT 30minutes for film
limits of dissolution test coated tablets. Our product is fast dissoving with
i.e., NLT 80% (Q) in 10 a dissolution specs of NLT 80% (Q) in 10
minutes. minutes and disintegration time of our product
is also found within 01 minute which co relates
with dissolution. We have revised the
specification of DT from NMT 30 minmutes to
NMT 10 minutes.
3.2.P.6 •Submitted COA of working Firm has submitted new COA of working
standard declares the standard, which had been standardized in
“Valid till” date as January January 2021 having validity date as of Jan,
2021, whereas trial batches 2022.
have been manufactured Firm has submitted that the working standard
and analyzed subsequent to complies with both & USP monograph of
this date. Paracetamol, since both the monographs are
• Submitted COA of working harmonized.
standard is of BP grade,
whereas drug product
specifications have been
claimed as per USP
monograph.
Decision: The Board was apprised that the firm has applied for two products with the similar
formulation that is Paracetamol, film coated tablet with slight difference in method of
manufacturing and qualitative composition. The Board after due deliberation decided to defer the
case for clarification whether an applicant can apply for registration of more than two products
having same composition or otherwise.
66. Name, address of Applicant / Marketing M/s SAMI Pharmaceuticals (Pvt) Ltd. F-95, Off
Authorization Holder Hub River Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s SAMI Pharmaceuticals (Pvt) Ltd. F-95, Off
Hub River Road, S.I.T.E. Karachi.

☐ Importer
Status of application ☒New Drug Product (NDP)
☐ Export sale
PROVAS SINU Capsules
name
Strength / concentration of drug of Active Each capsule contains:
Pharmaceutical ingredient (API) per unit Paracetamol …….…………. 500mg
Caffeine …….……………… 25mg
Phenylephrine HCl …………. 6.1mg
Pharmaceutical form of applied drug Unprinted Hard Gelatin Capsule size ‘0’ with orange
cap and orange body
Pharmacotherapeutic Group of (API) Paracetamol: NSAID
ATC Code: N02BE01
Caffeine: CNS Stimulant
ATC Code: N06BC01
Phenylephrine HCl: Sympathomimetic drug
ATC Code: R01BA53
Innovator’s Specs
specifications
The status in reference regulatory Sudafed Sinus Max Strength 500mg/25mg/6.1mg
authorities Capsule. Registered in EMA.
For generic drugs (me-too status) Not applicable
manufacturer
Name and address of API manufacturer. Paracetamol
Name:
HEBIE JIHENG (GROUP) PHARMACEUTICAL
CO., LTD.,
(Shortened as Jiheng Shenzhou)
Address:
Southeast Xijingming Village, Donganzhuang
Township, Shenzou County Hengshui City, Hebie
Province, CHINA
Caffeine
Name:
Shandong Xinhua Pharmaceutical Co.,Ltd
Address:
East Chemical Zone of Zibo High & new
technology development zone

Phenylephrine HCl
Name:
Shenzhen Oriental Pharmaceutical Co., Ltd
Address:
43 Dakeng Road Tongle Village, Longgang District
Shenzhen, China
characterization, impurities, specifications,
analytical procedures and its verification, batch
submitted.
process and controls, characterization, impurities,
system and stability studies of drug substance
Stability studies Paracetamol
Stability study conditions:
Months
Batches: (31404023, 31404024, 31404025)
months
Batches: (31106030, 31106031, 31106032)
Declaration for different batch numbers is provided
in the dossier
Caffeine
Months
Batches: (1307884, 1307890, 1307893)
6 months
Batches: (0904689, 0904690, 0904691)
in the dossier
Phenylephrine HCl
months
Batches: (PEH-170923, PEH-170924, PEH-170925)
months

Batches: (PEH-160404, PEH-160405, PEH-160406)

in the dossier
pharmaceutical development, impurities, individual
impurity and total impurity, specifications, analytical
procedure and its validation studies, batch analysis
and justification of specification, reference standard,
product.
comparative dissolution profile against the innovator product i.e. SUDAFED Sinus
Max Strength Capsule by M/s. McNeil Products
Ltd. by performing quality tests (Appearance,
Average weight, Disintegration, Assay, Dissolution,
Microbial Limit Test)
CDP has been performed against the same brand i.e.
SUDAFED Sinus Max Strength Capsule by M/s.
McNeil Products Ltd. in Acidic media (pH 1.2-4.5)
& Phosphate Buffer (pH 6.8). The values for f1 and
f2 are in the acceptable range.
Analytical method validation/verification Method validation studies have been submitted
of product including Linearity, Accuracy, and Precision
including Repeatability & Intermediate Precision,
Robustness and Specificity.
Manufacturer of API Paracetamol: HEBEI JIHENG (Group) Pharmaceutical Co. Ltd. China
Caffeine: Shandong Xinhua Pharmaceutical Co.,Ltd
Phenylephrine HCl: Shenzhen Oriental Pharmaceutical Co. Ltd. China
API Lot No. Paracetamol: 31709016
Caffeine: 19101463
Phenylephrine HCl: PEH-200303
Description of Pack
Alu/PVC (Opaque) blisters
Frequency Accelerated: 0, 1,2,3,4 & 6 (Months)
No. of Batches 03

1. Reference of previous approval of The firm has submitted reference of last onsite panel
applications with stability study data of the inspection for instant dosage form conducted during
firm (if any) last two years i.e. EMPOLI (Empagliflozin) 10mg &
25mg Tablets which was presented in 290th meeting
of the registration board & hence approved &
registered by registration board Date of inspection:
13th June 2019. The inspection report confirms
following points
monitored through software having alarm system
for alerts as well.
2. Approval of API/ DML/GMP certificate of Paracetamol
API manufacturer issued by concerned Copy of GMP certificate (HE20180054) issued to
regulatory authority of country of origin. M/s
HEBEI JIHENG (Group) Pharmaceutical Co. Ltd.
China
issued by China Food & Drug Control
Administration, valid till 08-07-2023 is submitted
Caffeine
Copy of GMP certificate (SD20190851) issued to
M/s. Shandong Xinhua Pharmaceutical Co. Ltd.
China issued by China Food & Drug Control
Administration, valid till 23-01-2024 is submitted
Phenylephrine HCl
Written confirmation for active substances exported
to EU, (Confirmation no. GD190014) issued to M/s.
Shenzhen Oriental Pharmaceutical Co. Ltd. China,
valid till 11-09-2022 is submitted
3. Documents for the procurement of API with Firm has submitted copy of following invoices
approval from DRAP (in case of import). specifying:
Paracetamol
5000kgs of Paracetamol (invoice # 1708ZP03)
attested by AD (I&E), Karachi dated 1-11-2017 is
submitted
Caffeine
Detail of loan material (250g of Caffeine Anhydrous,
Batch # 191101463) from M/s Semos
Pharmaceuticals (Pvt.) Ltd. along with copy of Form-
7 of the lot supplied by M/s Shandong Xinhua
Pharmaceutical Co. Ltd. under their invoice no.
XH191409 dated 07-11-2019
Copy of commercial invoice no. XH19140,9 in the

name of M/s Semos, for caffeine anhydrous (batch#
191101463), has also been submitted, attested b AD
DRAP I&E Karachi dated 01-01-2020.

Phenylephrine HCl
1kg of Phenylephrine HCl (Batch # PEH-200303)
(invoice # SZ-2003021) attested by AD (I&E),
Karachi dated 16-04-2020 is submitted
4. Data of stability batches will be supported Firm has submitted complete record of testing of all
by attested respective documents like batches along with chromatograms, raw data sheets,
chromatograms, Raw data sheets, COA, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail record of product
21CFR & audit trail reports on product testing of HPLC.
testing
accelerated)
• Regarding difference in the stability batches of Caffeine for accelerated and long-term conditions,
firm has submitted following declaration from M/s Shandong Xinhua:
“We did 3 batch stability at 30/75 conditions in 2013; since accelerated was already done in 2009
there was no need to repeat accelerated stability in 2013.”
• Regarding difference in the stability batches of Phenylephrine HCl, for accelerated and long-term
conditions, firm has submitted following declaration from M/s Shenzhen Oriental:
“While the batch of long-term stability data for Zone-Iva is not consistent with the accelerated
batch, it is because the Zone IV test started from 2017, which is also the first time 3 batches, not
involving the process and other any changes, no need to do accelerated tests again.”

3.2.S.5 COA of primary/working standard, Submitted
used by M/s Sami Pharma, for the
analysis of Caffeine, shall be
submitted.
1.6.5 Valid GMP certificate for the Firm has submitted copy of Drug
manufacturer of Phenylephrine HCl Manufacturing License (GD20160118)
shall be submitted instead of written valid upto 23-12-2025, issued by NMPA
confirmation for active substances China,
exported to EU.
3.2.P.5.1 MHRA Public assessment report of We have developed our product against the
the refence product recommends reference product Sudafed Sinus Max
dissolution specifications as “Not less Strength Capsules.
than 85% released in 15 minutes”, Comparative Dissolution profile (CDP) of
whereas firm has submitted PROVAS Sinus Capsule
dissolution specifications as “Not less 500mg/25mg/6.1mg Capsule with
than 85% in 30 minutes”. Justification reference product Sudafed Sinus Max
shall be submitted in this regard. Strength Capsules, shows satisfactory
comparable dissolution profile, and product
releases more than 85% within 15 minutes

in all 3 physiological mediums, data already
submitted.
Initially we have found the MHRA Public
Assessment Report of Grippostad day cold
and flu relief capsules (Paracetamol 300mg,
Phenylephrine hydrochloride 5mg and
caffeine 25mg) which does not mentioned
the specifications of dissolution test but not
found MHRA Public Assessment Report on
Max Strength Sinus Relief Capsules
(Paracetamol 500mg, Phenylephrine
hydrochloride 6.1mg and caffeine 25mg).
On query we searched again and found the
MHRA Public Assessment Report on Max
Strength Sinus Relief Capsules, and that is
archived, mentioning the dissolution test
‘Not less than 85% released in 15 minutes”.
But not mentioned the dissolution medium
and other dissolution test parameters.
We have performed the dissolution test of
our product PROVAS Sinu Capsule
500mg/25mg/6.1mg Capsule at 15 minutes
and 30 minutes on same lab scale batches
(which 6month data was submitted) after
18months at long term stability conditions
i.e. 30°C/75% RH and results are attached
(Annex 3)
Based on attached data, our product
complies the criteria of NLT 85 % in 15
minutes, therefore we revised the
specification of dissolution test ‘Not less
than 85% released in 15 minutes”. Revised
Specification and testing method are
attached for ready reference, and same
specifications will be use for the
commercial batches. Hope this will clarify
and justify the query
3.2.P.5.6 Justification shall be provided for the The development of specification and test
selection of dissolution parameters, method of Paracetamol 500mg + Caffeine
i.e., medium, apparatus & time. 25mg + Phenylephrine HCl 6.1mg capsule
is based on general chapters of USP & BP
and FDA guideline.
Dissolution: Paracetamol, Caffeine &

Phenylephrine HCl have solubility over the
range in aqueous conditions. Since it is non
– pharmacopeia product and no data is
published regarding dissolution medium,
and other parameters in various sites
including FDA dissolution data base till
now, therefore, in-house method has been
developed having following parameters
Apparatus USP Type I

(Basket)

Volume 900ml
Dissolution Medium Water
Speed (RPM) 100
Time 30 minutes
Basis of Selection of Dissolution

Parameters:
Paracetamol, Caffeine & Phenylephrine

HCl have solubility over a broad pH range
in aqueous conditions as evident from the
submitted CDP record (results above 85%
within 15 minutes) hence it was inferred
that solubility of all 3 APIs were not
affected by change in pH and therefore
water was selected as dissolution medium
Whereas, the speed, time and volume is

concerned, we follow the USP general
chapter<1092> Dissolution procedure:
Development and Validation which states
that:
For Speed:
For immediate-release capsule or tablet
formulations, Apparatus 1 (baskets) at 50–
100 rpm or Apparatus 2 (paddles) at 50 or
75 rpm are commonly used.
For Volume:
For compendial Apparatus 1 (basket) and
Apparatus 2 (paddle), the volume of the
dissolution medium can vary from 500 to
1000 mL.
For Time:
For immediate-release dosage forms, the
duration of the dissolution procedure is
typically 15 –60 mins
On the above basis, we have selected the

dissolution parameters viz Speed, time,
Medium and apparatus for release and
stability of finished product
3.2.P.6 • Submitted COA of working • Firm has submitted new COA of
standard declares the “Valid till” working standard, which had been
date as January 2021, whereas standardized in January 2021 having
trial batches have been and validity date as of Jan, 2022.
analysed subsequent to this date. • Firm has submitted that the working
• Submitted COA of working standard complies with both & USP
standard is of BP grade, whereas monograph of Paracetamol, since both
drug product specifications have the monographs are harmonized.
been claimed as per USP
monograph.

Decision of 320th meeting: Registration Board while considering the decision of 140th meeting of
Authority regarding Borrowing of APIs for performing Product Development, R&D & stability
Testing, decided to approved the product with Innovator’s specifications.
• Furthermore, the Board decided that the firm shall perform dissolution testing as per USFDA
method for all commercial batches.
67. Name, address of Applicant / M/s Getz Pharma (Pvt.) Limited
Marketing Authorization Holder 29-30/27, Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Getz Pharma (Pvt.) Limited
29-30/27, Korangi Industrial Area, Karachi.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. dated 29/09/2021
PKR 10,000/-: dated 29/09/2021
Rivaxo 2.5mg Tablets
name
Strength / concentration of drug of Each film-coated tablet contains:
Active Pharmaceutical ingredient (API) Rivaroxaban…..2.5mg
per unit
Pharmaceutical form of applied drug Pink colored, round shaped, biconvex film coated tablet,
engraved “GP” on one side and plain on other side.
Pharmacotherapeutic Group of (API) Antithrombotic agent
Innovator Specifications
specifications
Proposed Pack size 1x10’s
The status in reference regulatory Xarelto 2.5mg tablet by M/s Janssen Pharma, USA,
authorities USFDA Approved.
For generic drugs (me-too status) Revoban 2.5mg Tablet by M/s ATCO laboratories Ltd.,
Karachi.
(Reg. No. 089381)
GMP status of the Finished product Last GMP Inspection dated 03-12-2021 concludes that
manufacturer M/s Getz Pharma Pvt. Ltd. is considered to be operating
at an acceptable level of compliance of GMP
requirements. Tablet (General & General Antibiotic)
section approved.

Name and address of API manufacturer. M/s Jiangsu Yongan Pharmaceutical Co., Ltd.
No. 18, 237 provincial highway, Jiangsu Huai'an
Economic Development Zone, China.
Summarized information related to nomenclature,
structure, general properties, solubilities, physical form,
manufacturers, description of manufacturing process and
controls, impurities, specifications, analytical procedures
and its verification, batch analysis and justification of
system and stability studies of drug substance and drug
Module III (Drug Substance) Firm has submitted detail of nomenclature, structure,
Batches: (121201, 121202, 130101)
validation studies, batch analysis and justification of
comparative dissolution profile against Xcept 2.5mg Tablet by M/s PharmEvo (Pvt.)
Ltd., by performing quality tests (Appearance, Average
weight, Disintegration time, Assay and Dissolution).
CDP has been performed against the same brand that is
Xcept 2.5mg Tablet by M/s PharmEvo (Pvt.) Ltd., in
Purified Water, Acetate Buffer (pH 4.5) & Phosphate
Buffer (pH 6.8). The f2 values are in the acceptable
range.
Analytical method Method validation studies have submitted including,
validation/verification of product system suitability, specificity, linearity, accuracy,
precision repeatability, Intermediate precision and
robustness.
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co., Ltd.
No. 18, 237 provincial highway, Jiangsu Huai'an Economic
Development Zone, China.
API Lot No. 0000174102
Description of Pack
Alu-Alu blister packed in unit carton (1×10’s)

Batch No. 534DS06 534DS07 534DS08
Batch Size 9000 9000 Tablets 9000 Tablets
Tablets
Manufacturing Date 17-06- 26-06-2020 26-06-2020
2020
Date of Initiation 10-07-
10-07-2020 10-07-2020
2020
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of their
applications with stability study data of product for Estine (Ebastine) Tablets 10mg & 20mg on
the firm (if any) 6th May, 2019. Further, the said panel inspection report
was discussed in 289th Drug Registration Board meeting
held on 14th – 16th May 2019. The case was approved
and the inspection report confirms following points:
• The HPLC software is 21CFR Compliant as per
record available with the firm.
alerts as well.
• Related manufacturing area, equipment, personnel
and utilities are GMP compliant.
2. Approval of API/ DML/GMP certificate Firm has submitted copy of Drug Manufacturing License
of API manufacturer issued by no. Su 20160324 issued by Jiangsu Drug Administration
concerned regulatory authority of (Huai'an Inspection Branch) valid till 06-12-2025.
country of origin.
3. Documents for the procurement of API Copy of commercial invoice attested by AD I&E DRAP,
with approval from DRAP (in case of Karachi, has been submitted.
import). Date of
Batch Invoice Quantity approval
No. No. Imported by
DRAP
2019118 JXCAVIR- 25kg 04-03-
200207 2020
Firm has submitted data of stability batches along with
batch manufacturing record, analytical record and
attested documents like chromatograms, Raw data sheets,
COA, summary data sheets etc.
etc.
Firm has submitted compliance certificate of HPLC
software and audit trail reports on product testing.
testing
temperature and humidity monitoring of temperature & humidity monitoring of stability chambers

accelerated)
1.5.6 The section mentions “Not This is to inform you that product
applicable” against registration application of Rivaxo Tablets
pharmacopoeia reference for 2.5mg was submitted on Sep 23, 2021
applied product, whereas BP (receipted copy attached). However, official
monograph is available for applied monograph of Rivaroxaban Tablets has
product. been incorporated in British pharmacopeia
2022 edition.
• At the time of dossier submission,

official monograph of Rivaroxaban
Tablets was not available. Therefore,
“Not Applicable” is mentioned against
pharmacopeia reference for applied
product.
3.2.S.4.1 Submitted specifications and This is to inform you that product
analytical procedure are not as per registration application of Rivaxo Tablets
BP monograph of Rivaroxaban. 2.5mg was submitted on Sep 23, 2021
Test of Enantiomeric purity is not (receipted copy attached). However, official
included in the specifications. monograph of Rivaroxaban API has been
incorporated in British pharmacopeia 2022
edition.
At the time of dossier submission, official

monograph of Rivaroxaban API was not
available. Therefore, submitted
specification and analytical procedure are
not as per BP monograph of Rivaroxaban
and we have adopted specification and
testing procedure as provided by API
manufacturer.
• Firm has submitted updated

specification of Rivaroxaban API with
the inclusion of test of enantiomer.
3.2.P.2.2.1 Pharmaceutical equivalence & • This is to inform you that at the time of
CDP studies have not been product development stage, innovator
conducted against the innovator product was not available. However, we
product. have performed Pharmaceutical
Equivalence & Comparative
Dissolution Profile studies against
Xcept 2.5mg Tablets manufactured by
M/s PharmEvo (Pvt.) Ltd
3.2.P.5.1 Submitted specifications declare This is to inform you that product
reference as in-house, whereas BP registration application of Rivaxo Tablets
monograph is available for applied 2.5mg was submitted on Sep 23, 2021
product. (receipted copy attached). However, official
Submitted specifications and monograph of Rivaroxaban Tablets has
analytical procedure is not as per been incorporated in British pharmacopeia
BP monograph. 2022 edition.

• At the time of dossier submission,
official monograph of Rivaroxaban
Tablets was not available. Therefore,
submitted specifications and analytical
procedure declare reference as in-house.
3.2.P.8.3 • Submitted stability studies This is to inform you that we have
have not been conducted as per manufactured 03 batches of Rivaxo Tablets
specification and analytical 2.5mg for stability studies as follows:
procedure of BP monograph Batch
534DS06 534DS07 534DS08
for Rivaroxaban tablets. No.
Batch 9000 9000 9000
Size Tablets Tablets Tablets
Mfg. 17-06- 26-06- 26-06-
Date 2020 2020 2020
06 months accelerated and real time stability

studies were completed in Jan-2021 and the
dossier was submitted in Sep-2021.
At the time of dossier submission, official

monograph of Rivaroxaban Tablets was not
available. Therefore, submitted stability
studies have been conducted as per In-
House specification and analytical
procedure.
th
Decision of 320 meeting: Approved with BP specifications.
• The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
• Registration Board further decided that registration letter will be issued after submission of
CDP and pharmaceutical equivalence studies, performed against the innovator’s product i..e,
Xarelto tablet 2.5mg.
68. Name, address of Applicant / M/s The Schazoo Pharmaceutical Laboratories
Marketing Authorization Holder Pvt Ltd. Kalalwala Stop, 20 km Lahore-
Jaranwala Road, Distt Sheikhupura, Pakistan
Name, address of Manufacturing site. M/s The Schazoo Pharmaceutical Laboratories Pvt
Ltd.
Kalalwala Stop, 20 km Lahore-Jaranwala Road, Distt
Sheikhupura, Pakistan
☐ Importer
☐ Export sale

Brinza Eye Drops
name
Strength / concentration of drug of Active Each mL contains:
Pharmaceutical ingredient (API) per unit Brinzolamide ............ 10 mg
Brimonidine Tartrate ....... 2mg eq. to 1.3mg of
Brimonidine
Pharmaceutical form of applied drug
White to off-white color uniform suspension in white
opaque plastic bottles with green-cyan color plastic
caps, and finally packed in bleach board carton along
with a leaflet.
Pharmacotherapeutic Group of (API) Brinzolamide: Carbonic anhydrase Inhibitors

Brimonidine Tartrate: Alpha 2 adrenergic receptor
agonist
Schazoo's specification
specifications
Proposed Pack size 1 x5mL
The status in reference regulatory SIMBRINZA 10 mg/mL + 2 mg/mL eye drops,
authorities approved by US FDA
For generic drugs (me-too status) SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, of
Novartis (Reg.# 091907)
GMP status of the Finished product GMP Certificate #: 162/2019-DRAP (AD-1931718-
manufacturer 215) Dated: 28/06/2019
Evidence of manufacturing facility GMP Certificate #: 162/2019-DRAP (AD-1931718-
215) Dated: 28/06/2019 declares availability
Name and address of API manufacturer. Brimonidine Tartrate:
M/s FARMAK, a.s.
Na vlčinci 16/3, Klášterní Hradisko
779 00 Olomouc
Czech Republic
Phone: ++420/ 587430111, 585547111
Brinzolamide:
Duke Chem, S.A.
Pol. Industrial Sant Pere Molanta
Avgda. Mare de Déu de Montserrat, 93 - 99
Olèrdola
08799 Barcelona
SPAIN
DUNS No.: 461001138
solubilities, physical form, manufacturers, description
of manufacturing process and controls, impurities,

Module III (Drug Substance) Official monograph of Brinzolamide and Brimonidine
tartrate is present in USP 43. The firm as submitted
detail of nomenclature, structure, general properties,
of manufacturing process and controls, tests for
impurity D, G & related substances (impurity A &
unspecified), specifications, analytical procedures and
its verification, batch analysis and justification of
Brimonidine Tartrate: Real time: 30°C ± 2°C / 65%
± 5%RH for 24 months
Brinzolamide; Real time: 30°C ± 2°C / 65% ± 5%RH
for 48 months
Brimonidine Tartrate: (12010918, 12020918,

12030918)
Brinzolamide; (332700600, 332700700, 332700800)
impurities, specifications, analytical procedure
(including dissolution testing at acidic and buffer
medium) and its verification studies, batch analysis
product.
comparative dissolution profile against the brand leader that is Simbrinza eye drops
from SA Alcon-Couvreur NV, Rijksweg 14, BE-2870
Puurs, Belgium by performing quality tests
(Identification, sealing of caps, deliverable volume,
pH, Osmolality, viscosity, specific gravity,
redispersibility, assay and microbiological analysis).
Analytical method validation/verification Method verification studies have submitted including

of product linearity, range, accuracy, precision, specificity.
Manufacturer of Brimonidine Tartrate:
API M/s FARMAK, a.s.
Na vlčinci 16/3, Klášterní Hradisko
779 00 Olomouc
Czech Republic
Phone: ++420/ 587430111, 585547111
Brinzolamide:
M/s Duke Chem, S.A.
Pol. Industrial Sant Pere Molanta

Avgda. Mare de Déu de Montserrat, 93 - 99
Olèrdola
08799 Barcelona
SPAIN
DUNS No.: 461001138
API Lot No. Brimonidine Tartrate: (16020620)
Brinzolamide; (332701800)
Description of Pack Brimonidine Tartrate: The stability samples are stored in PE bags inside of PE
(Container closure boxes with screw caps, simulating the actual packaging system of BRIMONIDINE
system) TARTRATE drug substance.
Brinzolamide: Double transparent polyethylene bags contained inside high-

density polyethylene, simulates the packaging proposed for storage and
distribution of Brinzolamide
Time Period Brimonidine Tartrate: Real time: 24 months
Brinzolamide: Real time: 48 months
Batch No. BZD/T1/21 BZD/T2/21 BZD/T3/21
Batch Size 3 Ltr. 3 Ltr. 3 Ltr.
No. of Batches 03
1. Reference of previous approval of The firm has referred to Psi report of Valanza tablet
applications with stability study data of the conducte don 30th May 2019, wherein following
firm (if any) points have been reported:
l
2. Approval of API/ DML/GMP certificate of Brimonidine Tartrate: Copy of EUdra GMP
API manufacturer issued by concerned certificate No. sukls1705/2019 valid upto 13-02-2022.
regulatory authority of country of origin. Brinzolamide: Copy of EUdra GMP certificate
No.NCF-II/1924/001/CAT valid upto 28-01-2022.
3. Documents for the procurement of API Brimonidine Tartrate: Copy of commercial
with approval from DRAP (in case of invoice#: TWE-SCH I/04-20 attested by AD DRAP
import). I&E dated 03-02-2021
Brinzolamide: Copy of commercial invoice#:

TWE/SCH.01.20 attested by AD DRAP I&E dated 03-
02-2021
chromatograms,
sheets etc.

testing
accelerated)
Remarks of Evaluator:
Section# Observation Firm’s response

1.6.5 Valid GMP certificate of API Firm has submitted following:
manufacturers shall be submitted. Brimonidine Tartrate: Copy of EUdra GMP
certificate No. sukls260434/2021 valid upto Nov,
2024.
Brinzolamide: Copy of GMP certificate
No.NCF-II/2121/001/CAT valid upto May,
2024.
3.2.S.4.4 The COA of Brinzolamide from M/s Firm has submitted that COA of Brinzolamide
Schazoo declares testing as per BP from M/S Schazoo declares testing on USP rather
monograph, whereas drug substance BP. All tests were performed as per Brinzolamide
manufacturer has claimed USP USP monograph. Method of Analysis and
specifications. Specification subrnitted were also on USP. The
symbol (✓) indicates the new source rather BP.
However, COA of Brinzolamide highlighting
USP claim is attached for your kind reference.
3.2.S.5 COAs of primary/working standard, Submitted.
applied by the M/s Schazoo, for drug
substance analysis shall be
submitted.
3.2.P.3.3 • EMA assessment report of • The technique of aseptic ball milling has been
innovator product recommends used by the innovator, however, to ensure the
aseptic ball milling of particle size of Brinzolamide within range,
Brinzolamide as well as bulk we have used pre-sized material which is
sterilization of Brinzolamide controlled by the drug substance
solution, whereas both the steps manufacturer. Moreover, to ensure the
have not been included in the sterilization of Brinzolamide during
submitted manufacturing manufacturing and finished product, gamma
method. sterilization from Pakistan Radiation
• Submitted manufacturing method Services Lahore and micro-filtration
neither mentions terminal techniques are used.
sterilisation of the filled bottles • Moreover, to ensure the sterilization of
nor sterile filtration of the final Brinzolamide during manufacturing and
bulk suspension. Justification finished product, gamma sterilization from
shall be submitted regarding how Pa􀀅istan Radiation Services Lahore and
the sterility of the finished micro-filtration techniques are used.
product will be ensured.
3.2.P.5.1 Submitted drug product Boric acid has been as preservative in the
specifications does not include tests formulation. The contents of boric acid were
of boric acid identification, boric acid controlled by performing preservative
assay, particle size, as recommended effectiveness studies throughout stability studies.
by the literature of innovator product.
3.2.P.5.2 Submitted analytical method Firm has submitted that individual
determines Brinzolamide & chromatograph of Brinzolamide and

Brimonidine Tartrate Brimonidine, Blank, Excipient only and Product
simultaneously. Clarification shall be were submitted in Specificity (Analytical
submitted regarding the Method Validation File-Specificity). Now
identification of peak for each drug chromatograph with individual peaks of
substance. Brinzolamide & Brimonidine, Blank, Excipient
only and product is attached for your kind
reference.
3.2.P.5.3 Peak purity parameter has not been Firm has submitted chromatogram for peak
assessed in the performance of purity parameter.
specificity parameter.
3.2.P.5.6 Justification of specifications shall be Firm has submitted that a detailed comparative
provided. study of Brinza Eye Drops and Simbrinza Eye
Drops were performed. A comparative analysis
report was attached in PS. Tests were performed
according to the testing data provided by the
innovator in literature and USP Chapter 771.
3.2.P.8 • Stability studies have not been •
conducted at temperature & • Firm hassubmitted that hat Stability study
humidity conditions conducted according to ICH Quality
recommended for the semi- Guidelines. Water loss determination data
permeable container closure has been submitted along with SOP for Water
system. Loss Determinationin stability study.
• Test of particle size has not been
performed during stability • Firm has submitted that first of all particle
studies. size is controlled at the level of drug
substance and secondly at drug product stage
it is controlled under pressure of finished
product by carefully examining the product
for coagulation and agglomeration
throughout stability.
• Registration Board further decided that the firm shall revise product specifications for
inclusion of test of “Boric Acid Assay”and shall perform the said assay on commercial batches
and shall submit fee of Rs. 7500/- for correction/pre-approval change in product specifications
as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before issuance of
registration letter.
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd. Plot No. 384,
☐ Importer
facility dated 24-06-2019 which specifies SVP general section.

☐ Export sale
The proposed proprietary name / brand Pacific WFI Injection 5 ml
name
Active Pharmaceutical ingredient (API) Sterile water for injection …… 5ml
per unit
Pharmaceutical form of applied drug Intravenous (IV) solution
Pharmacotherapeutic Group of (API) Pharmacological Class: Water for Injections is a non-
isotonic solution.
Pharmacotherapeutic group: Solvent/Vehicle
ATC code: V07AB(WHO)
specifications
The status in reference regulatory Approved by TGA of Australia.
authorities
For generic drugs (me-too status) Otsuka Water for Injection 5ml Otsuka Pakistan Ltd
Registration number # 081541
Name and address of API manufacturer. M/s Pacific Pharmaceuticals Ltd. Plot No. 384,
Stability Studies of Drug Substance Firm has submitted that water for injection in bulk is
(Conditions duration of Stability stored in SS container and is immediately filled in
studies) ampoules within 24 hours therefore stability studies are
not required to be carried out in this container closure
system.

development, manufacture, manufacturing process and
process control, process validation protocols, control of
Comparative Dissolution Profile reference product of “Otsuka sterile Water for
Injection 5mL by Otsuka Pakistan Ltd”
batches at both accelerated and long-term conditions.
Manufacturer of APIs M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
Industrial Estate, Lahore
API Lot No. N/A
Description of Pack Low density polyethylene (LDPE) ampoule with twist head
(Container closure system) cap.
Real time: 30oC ± 2oC / 35% HR ±5%
Real time: 18 months
Time Period
Frequency
Real Time: 0, 3, 6, 9, 12, 18 (Months)
Batch No. PDXN0012020 PDXN0022020 PDXN0032020
data of the firm (if any)
2. Approval of API/ DML/GMP M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
certificate of API manufacturer Industrial Estate, Lahore. GMP certificate issued on 17-07-
issued by concerned regulatory 2020 by DRAP Pakistan.
case of import).
4. Data of stability batches will be Firm has submitted data of stability batches along with batch
supported by attested respective manufacturing record and analytical record.
data sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail reports on product testing.

6. Record of Digital data logger for Firm has submitted Record of Digital data logger for
temperature & humidity temperature & humidity monitoring of stability chambers
monitoring of stability chambers (real time and accelerated)

70. Name, address of Applicant / M/s Pacific Pharmaceuticals Ltd.
Marketing Authorization Holder Plot No. 384, Sunder Industrial Estate, Lahore
Name, address of Manufacturing site. M/s Pacific Pharmaceuticals Ltd.
Plot No. 384, Sunder Industrial Estate, Lahore
☐ Importer
facility dated 24-06-2019 which specifies SVP general section.
☐ Export sale
Details of fee submitted Rs.30,000/- Dated: 03-02-2022
The proposed proprietary name / brand Pacific WFI Injection 10 ml
name
Active Pharmaceutical ingredient Sterile water for injection …… 10ml
(API) per unit
Pharmaceutical form of applied drug Intravenous (IV) solution
Pharmacotherapeutic Group of (API) Pharmacological Class: Water for Injections is a non-
isotonic solution.
Pharmacotherapeutic group: Solvent/Vehicle
ATC code: V07AB(WHO)
specifications
The status in reference regulatory Approved by TGA of Australia
authorities
For generic drugs (me-too status) Otsuka Water for Injection 10ml Otsuka Pakistan Ltd.
Registration number # 048517

Dosage form: Intravenous (IV) Solution (Non
isotonic)
Name and address of API M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
manufacturer. Industrial Estate, Lahore
Stability Studies of Drug Substance Firm has submitted that water for injection in bulk is
(Conditions duration of Stability stored in SS container and is immediately filled in
studies) ampoules within 24 hours therefore stability studies are
not required to be carried out in this container closure
system.
Comparative Dissolution Profile reference product of “Otsuka Water for Injection 10ml
by Otsuka Pakistan Ltd.”
Analytical method Firm has submitted Performance Qualification report of
validation/verification of product WFI.
Manufacturer of APIs M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
API Lot No. N/A
Description of Pack Low density polyethylene (LDPE) ampoule with twist head
(Container closure system) cap.
Real time: 30oC ± 2oC / 35% HR ±5%
Time Period

Frequency
Real Time: 0, 3, 6, 9, 12, 18 (Months)
Batch No. PDXM0012020 PDXM0022020 PDXM0032020
2. Approval of API/ DML/GMP M/s Pacific Pharmaceuticals Ltd. Plot No. 384, Sunder
certificate of API manufacturer Industrial Estate, Lahore. GMP certificate issued on 17-07-
issued by concerned regulatory 2020 by DRAP Pakistan.
case of import).
supported by attested respective Firm has submitted data of stability batches along with batch
documents like chromatograms, manufacturing record and analytical record.
data sheets etc.
software 21CFR & audit trail Firm has submitted audit trail reports on product testing.
temperature & humidity monitoring of stability chambers

71. Name, address of Applicant / M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-205
Marketing Authorization Holder Industrial Triangle, kahuta Road, Islamabad-25000,
Pakistan
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-205
Industrial
Triangle, kahuta Road, Islamabad-25000, Pakistan
☐ Importer
☐ Export sale

Soglu-Met 5mg/850mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin ……. 5mg
per unit Metformin HCl …….. 850mg
Pharmacotherapeutic Group of (API) sodium-glucose co-transporter 2 (SGLT2) inhibitors.
biguanide class of antidiabetics
Innovator specs
specifications
The status in reference regulatory SYNJARDY 5mg/850mg Tablet of Boehringer
authorities Ingelheim Canada LTD LTEE. (Health Canada
approved)
For generic drugs (me-too status) Xenglu-Met 5mg/850mg Tablet of Hilton Pharma Pvt.
LTD.
GMP status of the Finished product The firm is granted GMP certificate based on inspection
manufacturer conducted on 03-01-2022 and it is valid till 02-01-2024.
Name and address of API manufacturer. Empagliflozin: FUXIN LONG RUI
PHARMACEUTICAL Co.,Ltd. Fluoride industrial
park, Fuxin city, Liaoning province, 123000, China.
Metformin HCl: AARTI DRUGS LIMITED Plot No.
211 - 213, Road No.2 G.I.D.C., Sarigam, Dist.: Valsad,
Gujarat. INDIA.396155
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure,
and controls, tests for impurity & related substances,
Real time: 30°C ± 2°C, RH: 65% ± 5% for 24 months
Accelerated: 40°C ± 2°C, RH: 75% ± 5% for 6
months

Batches: (20160606, 20161017, 20161219)
Metformin HCl:
Real time: 30°C ± 2°C, RH: 65% ± 5% for 48 months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
medium) and its verification studies, batch analysis and
product.
Pharmaceutical equivalence and The Firm has performed pharmaceutical equivalence
comparative dissolution profile and comparative dissolution profile of their developed
formulation Soglu-Met 5mg/850mg Tablet (B #
ST21A009) with innovator product Synjardy
5mg/850mg Tablet (B #902007) of M/s Boehringer
Ingelheim Pharma. in pH 1.2, acetate buffer pH 4.5 and
phosphate buffer pH 6.8. The results of CDP showed
that release
profile of both test and comparator products were
comparable. The values for f2 factor are in the
acceptable range.
Manufacturer of API Empagliflozin: FUXIN LONG RUI PHARMACEUTICALCo.,Ltd.
Fluoride industrial park, Fuxin city, Liaoning province, 123000, China.
Metformin HCl: AARTI DRUGS LIMITED
Plot No. 211 - 213, Road No.2 G.I.D.C., Sarigam, Dist.: Valsad,
API Lot No. Empagliflozin: E-20190920-D02-E06-01
Metformin HCL: MEF/10030953
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (1×14’s)
system)
Batch No. ST21A009 ST21A010 ST21A011

No. of Batches 03
1. Reference of previous approval of The firm has referred to previous inspection of stability
applications with stability study data of data of
the firm (if any) the same dosage form on the basis of which Registration
Board
in 289th meeting decided to approve registration of
Promig Plus
500mg/20mg Tablet and Promig Plus 375mg/20mg
Tablet.
Inspection date: 14th March, 2019
The report shows that:
The HPLC software is 21 CFR compliant.
The firm has provided data loggers with stability
chambers.
2. Approval of API/ DML/GMP certificate Empagliflozin: The firm has submitted GMP certificate
of API manufacturer issued by concerned for M/s Fuxin Long Rui Pharmaceutical Co., Ltd, China
regulatory authority of country of origin. issued by Fuxin Food and Drug Administration. The
certificate is valid till 23-08-2023
Metformin HCl: The firm has submitted GMP
certificate for AARTI Drugs limited issued by food &
drug Control Administration. The certificate is valid till
19-03-2023
3. Documents for the procurement of API Empagliflozin: The firm has submitted attested copy of
with approval from DRAP (in case of invoice for the import of empagliflozin (1.5 Kg, Invoice
import). # HN19120501-H) dated 05-12-2019 and attested copy
of ADC (I&E) DRAP, Islamabad dated 10-01-2020
Metformin HCL: The firm has submitted attested copy
of invoice for the import of Metformin Hcl (1000 Kg,
Invoice # EXP/302/20-21) dated 15-5-2020. And
attested ADC (I&E) DRAP, Islamabad dated 05-08-
2020.
4. Data of stability batches will be supported Firm has submitted record of testing of all batches along
by attested respective documents like with chromatograms, raw data sheets, COA and
chromatograms, summary data sheets.
sheets etc.
5. Compliance Record of HPLC software Audit trail reports have been submitted for HPLC
21CFR & audit trail reports on product analysis of stability studies.
testing
6. Record of Digital data logger for Firm has submitted record of data logger for
accelerated)

• Registration Board further advised the firm to follow the relevant guidelines for preparation,
standardization and usage of standard for testing of drug substance and product.
72. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd. Plot # 204-205
Authorization Holder Industrial
Industrial
☐ Importer
☐ Export sale
Soglu-Met 12.5mg/850mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin…….12.5mg
per unit Metformin HCl….850mg
Innovator specs
specifications
The status in reference regulatory SYNJARDY 12.5mg/850mg Tablet of Boehringer
approved)
For generic drugs (me-too status) Xenglu-Met 12.5mg/850mg Tablet of Hilton Pharma
Pvt. LTD.
PHARMACEUTICALCo.,Ltd. Fluoride industrial
Metformin HCL: AARTI DRUGS LIMITED
Plot No. 211 - 213, Road No.2
G.I.D.C., Sarigam, Dist.: Valsad,

Real time: 30°C ± 2°C, RH: 65% ± 5% for 24
months
months
Batches: (20160606, 20161017, 20161219)
Metformin HCL:
months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
product.
formulation Soglu-Met 12.5mg/850mg Tablet (B #
12.5mg/850mg Tablet (B #803625) of M/s Boehringer
that release
acceptable range.

Metformin HCl: MEF/10030953
Description of Pack
system)
No. of Batches 03
Board
Promig Plus
Tablet.
chambers.
19-03-2023

2020.
sheets etc.
testing
accelerated)
standardization adn usage of standard for testing of drug substance and product.
Industrial Triangle, kahuta Road, Islamabad-25000,
Pakistan
☐ Importer
☐ Export sale
Soglu-Met 12.5mg/1000mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin…….12.5mg
per unit Metformin HCl….….1000mg

Innovator specs
specifications
The status in reference regulatory SYNJARDY 12.5mg/1000mg Tablet of Boehringer
approved)
For generic drugs (me-too status) Xenglu-Met 12.5mg/1000mg Tablet of Hilton Pharma
Pvt. LTD.
Name and address of API manufacturer. Empagliflozin: Fuxin Long Rui Pharmaceutical
Co.,Ltd. Fluoride industrial park, Fuxin city, Liaoning
province, 123000, China.
Metformin HCL: Aarti Drugs Limited Plot No. 211 -
213, Road No.2 G.I.D.C., Sarigam, Dist.: Valsad,
months
months
Batches: (20160606, 20161017, 20161219)
Metformin HCL:
months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)

product.
formulation Soglu-Met 12.5mg/1000mg Tablet (B #
12.5mg/1000mg Tablet (B #002022) of M/s Boehringer
that release
acceptable range.
Description of Pack
system)
No. of Batches 03
Board

Promig Plus
Tablet.
chambers.
19-03-2023
2020.
sheets etc.
testing
accelerated)
standardization adn usage of standard for testing of drug substance and product.
Industrial

☐ Importer
☐ Export sale
Soglu-Met 5mg/1000mg Tablet
name
Active Pharmaceutical ingredient (API) Empagliflozin…….5mg
per unit Metformin HCl….….1000mg
Innovator specs
specifications
The status in reference regulatory SYNJARDY 5mg/1000mg Tablet of Boehringer
approved)
For generic drugs (me-too status) Xenglu-Met 5mg/1000mg Tablet of Hilton Pharma Pvt.
LTD.
PHARMACEUTICALCo.,Ltd. Fluoride industrial
Plot No. 211 - 213, Road No.2
G.I.D.C., Sarigam, Dist.: Valsad, Gujarat.
INDIA.396155

and controls, specifications, analytical procedures and
months
months
Batches: (20160606, 20161017, 20161219)
Metformin HCL:
months
months
Batches: (MEF/1410027, MEF/1410028,
MEF/1410029)
verification studies, batch analysis and justification of
formulation Soglu-Met 5mg/1000mg Tablet (B #
5mg/1000mg Tablet (B #902325) of M/s Boehringer
that release
acceptable range.
Metformin HCl: AARTI DRUGS LIMITED
Description of Pack
system)

No. of Batches 03
Board
Promig Plus
Tablet.
chambers.
19-03-2023
2020.
by attested respective documents like with
chromatograms, chromatograms, raw data sheets, COA and summary
Raw data sheets, COA, summary data data sheets.
sheets etc.
testing

accelerated)
Sr.# Section# Observation Firm’s response
1. 3.2.S.4.2 Drug substance analytical Revised analytialprocedure has
procedure of Metformin HCl benesubmitted as per latest
is not as per the latest monograph of USP for Metformin
monograph of USP for HCl
Metformin HCl.
2. 3.2.S.4.3 Analytical method Analytical method verification
verification studies shall be studies have been submitted from
submitted from M/s Global M/s Global Pharmaceuticals for
Pharmaceuticals for Metformin HCl as per latest
Metformin HCl for the monograph of USP.
analytical method fo latest
monograph of USP.
3. 3.2.P.5.1 • Submitted drug product • Firm has submitted as under:
specifcations does not “We have performed ontent
include test of content uniformity at finished dosage
uniformity for form but do not include this in
Empagliflozin. the stability study report. Now
• The USFDA review firm has submitted analytical
documents of innovator record for the content
product i.e., Synjardy uniformity testing a finished
declares the dissolution stage and at 15 month time
specifications as “NLT Q point.”
in 20 minutes”, while • Empagliflozin & metformin
you have applied HCl are bCS class III drugs
dissolution limits of NLT (rapidly dissolving drugs) and
Q in 30minutes. for rapidly dissolving drugs
Justification shall be FDA guideline “Guidance for
submitted in this regard. industry:- Dissolution testing
and Acceptance criteria for
immediate release solid oral
dosage form drug products
containing high solubility drug
substances menton the
dissolution specification NLT
80% after 30 mminutes.
We performed and submitted
the dissolution testing data with
time point i.e., 05,10,15,20&
30 minutes at initial “Finshed
stage” and at 6th month time
point.”
4. 3.2.P.6 Date of re-standardization Firm has submitted re-
has been declared as 24-01- standardization record for the
2021 for the working working standard of
standard of Empagliflozin, Empagliflozin.
whereas stability study
analysis has also been

performed subsequent to this
date.

standardization and usage of standard for testing of drug substance and product.
75. Name, address of Applicant / Marketing "M/s High-Q Pharmaceuticals.
Authorization Holder B-64 KDA-1, Karsaz Road Karachi,”
Name, address of Manufacturing site. M/s High-Q Pharmaceuticals.
Plot No.224 & 225/1 Sector 23, Korangi Industrial
Area, Karachi-Pakistan
☐ Importer
☐ Export sale
Ertagsa 5/100 mg Tablet
name
Active Pharmaceutical ingredient (API) 6.48 mg ertugliflozin L-pyroglutamic acid equivalent
per unit to 5 mg of ertugliflozin and
128.5 mg sitagliptin phosphate monohydrate equivalent
to 100 mg sitagliptin
Pharmaceutical form of applied drug Pink color, oval shaped, biconvex, film coated tablet
with bisect line on one side and other side is plain.
Pharmacotherapeutic Group of (API) Ertugliflozin: Sodium-glucose co-transporter 2
(SGLT2) inhibitors
Sitagliptin: Dipeptidyl peptidase-4 (DPP-4) inhibitors
Manufacturer’s Specification
specifications
The status in reference regulatory “Steglujan 5/100mg Tablet” by Merck & Co., inc.
authorities Approved by US FDA

For generic drugs (me-too status) Ertuvia 5mg + 100mg Tablet by Ferozsons
Laboratories Limited
GMP status of the Finished product New license granted on 21st Dec, 2021
manufacturer Tablet (General & General Antibiotic) section
approved.
Name and address of API manufacturer. SITAGLIPTIN:

Manufacturing facility name:
Fuxin Long Rui Pharmaceutical CO.,Ltd
Manufacturing facility address:
Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province -123000, China
Exporting company name:
Beijing Sino Hanson Import & Export Co. Ltd
Exporting company Address:
No 3, Zhonghe Road, Fengtai District, Beijing China
100070
ERTUGLIFLOZIN-LPGA:
DMF Holder: Shanghai Pansopharm Technology Co.,
Ltd.
Address:2F, Bldg. 7, 333# East Kangqiao Rd., Pudong,
Shanghai, China
Manufacturer:
Chifeng Arker Pharmaceutical Technology Co., Ltd.
Manufacturing Site: No. 8 Mysun Street, Hongshan
Economic Development Zone, Chifeng, Inner
Mongolia, China
Module III (Drug Substance) Ertugliflozin-LPGA & Sitagliptin are not present in any
Pharmacopoeia and the firm has followed
manufacturer’s specification. The firm has submitted
detail of nomenclature, structure, general properties,
of manufacturing process and controls, tests for
impurity & related substances, analytical procedures
Stability studies Ertugliflozin-LPGA:
Firm has submitted stability study data of 3 batches of
drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted
at 40oC ± 2oC / 75% ± 5% RH for 6 months. The real

time stability data is conducted at 30oC ± 2oC / 65% ±
5% RH for 48 months
Batches: (D84-161201, D84-161202, D84-170101)
Sitagliptin:
at 40oC ± 2oC / 75% ± 5% RH. The real time stability
data is conducted at 30oC ± 2oC / 75% ± 5% RH.
Batches:
For Accelerated studies
(M-20190127-D01-M06-06,
M-20190316-D02-M06-07, M-20190127-D01-M06-
08)
For Real time studies
(M-20190127-D01-M06-01,
M-20181222-D06-M06-08, M-20181222-D06-M06-
09)

product.
Pharmaceutical equivalence and CDP studies against the reference product of Steglujan
comparative dissolution profile tablets, in three dissolution mediums has been
submitted with acceptable level of f2 results (f2 ≥ 50).
Analytical method validation/verification Firm has submitted analytical method validation data
of product
Manufacturer of API SITAGLIPTIN:
ERTUGLIFLOZIN-LPGA:
DMF Holder: Shanghai Pansopharm Technology Co., Ltd.
Manufacturer:Chifeng Arker Pharmaceutical Technology Co., Ltd.
API Lot No. Sitagliptin phosphate monohydrate: M-20191228-D07-M06-04
Ertugliflozin-LPGA: D84-191001
Description of Pack
system)
Frequency Accelerated: 0,1,2,3 & 6 (Months)
Real Time: 0, 3 & 6 (Months)
Batch No. 5ESPD01/20 5ESPD02/20 5ESPD03/20

No. of Batches 03
1. Reference of previous approval of Attached
the firm (if any)
2. Approval of API/ DML/GMP certificate Ertugliflozin-LPGA: Copy of GMP certificate issued
of API manufacturer issued by concerned by CFDA in the name of M/s Chifeng Arker
regulatory authority of country of origin. Pharmaceutical Technology Co., Ltd., China provided
Sitagliptin phosphate monohydrate: Copy of GMP
Certificate issued by the CFDA in the name of M/s
Fuxin Long Rui
Pharmaceutical Co., Ltd., Liaoning Province, China.
valid upto May/25/2024.
3. Documents for the procurement of API Copy of commercial invoice attested by AD I&E
with approval from DRAP (in case of DRAP, Karachi, has been submitted.
import). Sitagliptin phosphate monohydrate:
Batch No. Invoice Quantity Date of
No. Imported. approval
by
DRAP
M- MR200219- 200Kg 26-02-
20191228- H 2020
D07-M06-
04
Ertugliflozin-LPGA:
Batch Invoice Quantity Date of
No. No. Imported. approval
by
DRAP
Not PSPW- 1Kg 12-11-
Available 191025 2019
chromatograms,
sheets etc.
testing
6. Record of Digital data logger for Yes
accelerated)
76. Name, address of Applicant / "M/s High-Q Pharmaceuticals. B-64 KDA-1, Karsaz
Marketing Authorization Holder Road Karachi,”
Name, address of Manufacturing site. M/s High-Q Pharmaceuticals.

Plot No.224 & 225/1 Sector 23, Korangi Industrial Area,
Karachi-Pakistan
☐ Importer
Ertagsa 15/100 mg Tablet
brand name
Active Pharmaceutical ingredient 19.43mg Ertugliflozin L-pyroglutamic acid equivalent to
(API) per unit 15 mg of Ertugliflozin and
128.5 mg Sitagliptin phosphate monohydrate equivalent
to 100 mg Sitagliptin
Pharmaceutical form of applied drug Brown colored, oval shaped, biconvex, film coated tablet
with bisect line on one side and plain on other side
Pharmacotherapeutic Group of (API) Ertugliflozin: Sodium-glucose co-transporter 2 (SGLT2)
inhibitors
Sitagliptin: Dipeptidyl peptidase-4 (DPP-4) inhibitors
Manufacturer’s Specification
specifications
The status in reference regulatory “Steglujan 15/100mg Tablet” by Merck & Co., inc.
authorities Approved by US FDA
For generic drugs (me-too status) Ertuvia 15mg + 100mg Tablet by Ferozsons Laboratories
Limited
GMP status of the Finished product New license granted on 21st Dec, 2021
manufacturer Tablet (General & General Antibiotic) section approved.
Name and address of API SITAGLIPTIN:
manufacturer. Manufacturing facility name:
Manufacturing facility address:
Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province -123000, China
Exporting company name:
Beijing Sino Hanson Import & Export Co. Ltd
Exporting company Address:
No 3, Zhonghe Road, Fengtai District, Beijing China
100070
ERTUGLIFLOZIN-LPGA:
DMF Holder: Shanghai Pansopharm Technology Co.,
Ltd.

Address:2F, Bldg. 7, 333# East Kangqiao Rd., Pudong,
Shanghai, China
Manufacturer:
Chifeng Arker Pharmaceutical Technology Co., Ltd.
Manufacturing Site: No. 8 Mysun Street, Hongshan
Economic Development Zone, Chifeng, Inner Mongolia,
China
specification, reference standard, container closure system
and stability studies of drug substance and drug product is
submitted.
Module III (Drug Substance) Ertugliflozin-LPGA & Sitagliptin are not present in any
Pharmacopoeia and the firm has followed manufacturer’s
specification. The firm has submitted detail of
manufacturing process and controls, tests for impurity &
related substances, analytical procedures and its
Stability studies Ertugliflozin-LPGA:
conditions. The accelerated stability data is conducted at
40oC ± 2oC / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30oC ± 2oC / 65% ± 5% RH
for 48 months.
Batches: (D84-161201, D84-161202, D84-170101)
Sitagliptin:
40oC ± 2oC / 75% ± 5% RH. The real time stability data is
conducted at 30oC ± 2oC / 75% ± 5% RH.
Batches:
For Accelerated studies
(M-20190127-D01-M06-06,
M-20190316-D02-M06-07, M-20190127-D01-M06-08)
For Real time studies
(M-20190127-D01-M06-01,
M-20181222-D06-M06-08, M-20181222-D06-M06-09)
impurities, specifications, analytical procedure (including
dissolution testing at acidic and buffer medium) and its

Pharmaceutical equivalence and CDP studies against the reference product of Steglujan
comparative dissolution profile tablets, in three dissolution mediums has been submitted
with acceptable level of f2 results (f2 ≥ 50).
Analytical method Firm has submitted analytical method validation data
validation/verification of product.
Manufacturer of API SITAGLIPTIN:
ERTUGLIFLOZIN-LPGA:
DMF Holder: Shanghai Pansopharm Technology Co., Ltd.
Manufacturer:Chifeng Arker Pharmaceutical Technology Co., Ltd.
API Lot No. Sitagliptin phosphate monohydrate: M-20191228-D07-M06-04
Ertugliflozin-LPGA: D84-191001
Description of Pack
system)
Frequency Accelerated: 0,1,2,3 & 6 (Months)
Real Time: 0, 3 & 6 (Months)
Batch No. 1ESPD01/20 1ESPD02/20 1ESPD03/20

No. of Batches 03
1. Reference of previous approval of Attached
the firm (if any)
2. Approval of API/ DML/GMP Ertugliflozin-LPGA: Copy of GMP certificate issued by
certificate of API manufacturer issued CFDA in the name of M/s Chifeng Arker Pharmaceutical
by concerned regulatory authority of Technology Co., Ltd., China provided
country of origin. Sitagliptin phosphate monohydrate: Copy of GMP
Certificate issued by the CFDA in the name of M/s Fuxin
Long Rui
Pharmaceutical Co., Ltd., Liaoning Province, China.
valid upto May/25/2024.
3. Documents for the procurement of API Copy of commercial invoice attested by AD I&E DRAP,
with approval from DRAP (in case of Karachi, has been submitted.
import). Sitagliptin phosphate monohydrate:
Batch No. Invoice Quantity Date of
No. Imported. approval
by
DRAP

M- MR200219- 200Kg 26-02-
20191228- H 2020
D07-M06-
04
Ertugliflozin-LPGA:
Batch Invoice Quantity Date of
No. No. Imported. approval
by
DRAP
Not PSPW- 1Kg 12-11-
Available 191025 2019
sheets etc.
testing
6. Record of Digital data logger for Yes
accelerated)
Sr.# Section# Observation Firm’s response

1. 1.6.5 Valid GMP certificate of the Submitted from Changzhou
manufacturer of Ertugliflozin L- Pharmaceutical Profession
PGA shall be submitted. Association wghich is not relevant
regulatory authority.
Ertugliflozin L-Pyroglutamic acid
2. 3.2.S.4 • Copies of the Drug substance • Submitted.
specifications and analytical • As per the manufacturer:
procedures used for routine Ertugliflozin potency =
testing of the Drug substance Ertugliflozin LPGA Assay - LPGA
/Active Pharmaceutical content.
Ingredient by Drug Pro duct So, they have shown only two test
manufacturer is required. results of them on the COA, instead
• Submitted specifications and of all three, because the third
analytical procedure by drug outcome can be calculated out.
substance manufacturer • Analytical method verification
describes the test for content of report has been submitted. As
“Ertugliflozin L-pyroglutamic per submitted analytical record
acid, whereas the Innovator’s various chromatograms have
product literature recommends been analysed with retention
test of “Ertugliflozin potency” time of 20 minutes whereas
in the drug substance analytical procedure
specifications. recommends gradient run time
• Analytical Method Verification of 45 minutes.
studies including specificity, • Submitted.
accuracy and repeatability • Firm has submitted Revised
(method precision) performed CoA with Ertugliflozin content
by the Drug Product is submitted.

manufacturer shall be • Revised CoA of material with
submitted. test of L-pyroglutamic acid
• Analytical record i.e., Raw data content is submitted.
sheet, FTIR spectrum, The test for L-PGA was
chromatograms etc., shall be performed after the submission,
submitted for the analysis of considering that
‘Ertugliflozin L-pyroglutamic theoretical factor calculated
Acid’ performed by M/s High- using molecular weights can
Q Pharmaceuticals. serve the purpose for
• COA from drug substance small size trial batches.
manufacturer does not declare This test has now been
the “Ertugliflozin potency” as performed on the retention
recommended by the innovator sample of API and included in
product. the specification for routine
• COA from of drug substance testing of API for commercial
from drug product batches of the product
manufacturer does not include
test of L-Pyroglutamic acid
content.
3. 3.2. S.5 • COA of reference standard of • CoA of Reference standard of
L-Pyroglutamic acid shall be L-pyroglutamic acid is
submitted. submitted.
• Submitted COAs of reference • Updated CoA of Reference
standard of Ertugliflozin L- standard with L-pyroglutamic
PGA does not mention any acid content is attached.
manufacturing date, validity Batch number: B34-191001
date & batch no. Mfg Date: Oct 26, 2019
• Submitted COA of reference Retest Date: Oct 25, 2021
standard does not declare the
content of L-pyroglutamic acid.
4. 3.2. S.7 Justification shall be submitted forFirm has submitted declaration
not performing test of L-PGA from drug substance manufacturer:
content throughout the stability On the stability data of Ertugliflozin
studies. L-PGA, L-PGA content is only
shown in month 0 and month
24, because L-PGA is very stable,
and doesn't degrade within 3-4
years, so we tested it every two
years in the stability studies
initially.
If customer insist to have L-PGA
content data in each column, then
we'll add the test results from
next stability batch.
Sitagliptin phosphate monohydrate
5. 3.2.S.4 • Copies of the Drug substance Firm has submitted specifications,
specifications and analytical analytical procedure, analytical
procedures used for routine method verification report,
testing of the Drug substance analytical record for Drug
/Active Pharmaceutical substance analysis and COAs.
Ingredient by Drug Product
• Analytical Method Verification
studies including specificity,

accuracy and repeatability
(method precision) performed
by the Drug Product
manufacturer shall be
submitted.
• Analytical record i.e., Raw data
sheet, FTIR spectrum,
chromatograms etc., shall be
submitted performed by M/s
High-Q Pharmaceuticals.
• Provide Certificate of Analysis
(CoA) of relevant batch(es) of
Drug Substance performed by
Drug substance manufacturer
used during product
development and stability
studies.
6. 3.2.S.5 • Submitted COA of working Revised COA of working standard
standard declares the expire has been submitted with expiry date
date as 24-07-2018, whereas the of 14-02-2023.
drug substance analysis has
been performed subsequent to
this date.
7. 3.2.S.7 • Long term stability studies have Long term stability data as per Zone
been submitted for 6 months IVa conditions has been submitted
only. for 24 months.
8. 3.2.P.1 • Excipients used in the proposed • Firm has referred to drug
formulation are different form excipient compatibility study as
that used by the Innovator. justification.
Justification shall be submitted • Quick Tab is a pre-mix used as
in this regard. Binder, filler and disintegrant.
• Clarification shall be submitted
regarding composition of
“Quick tab” used in the
formulation.
9. 3.2.P.3.5 Sampling plan of compression Revised Process validation protocol
stage, presented in the submitted submitted.
process validation protocol, does
not include test of content
uniformity. Justification shall be
submitted in this regard.
10. 3.2. P.5.1 • Drug substance specifications • Firm has submitted drug
have been submitted instead of product specifications.
the drug product specifications. • There was a typo error; the
• Dissolution parameters of actual paddle speed is 50 rpm as
apparatus (paddle instead of mentioned in Comparative
basket), dissolution medium Dissolution Profile documents
(v/0.1N HCl instead of pH (Biowaiver Studies Protocol),
4.5acetate buffer) & dissolution already submitted. The testing
volume (1000ml instead of was done following that
900ml), proposed in analytical procedure.
procedure, are different from • The medium (0.1N HCI pH 1.2)
that recommended by the US was selected as both
FDA in the innovator’s product ertugliflozin and sitagliptin

literature review. Justifications meet the requirements of BCS
shall be submitted in this Class I drug due to high
regard. solubility across physiological
• You have applied Paddle speed pH range and high permeability.
= 100 rpm in dissolution Ertugliflozin / sitagliptin tablets
parameters. You are advised to display rapid in vitro dissolution
justify the speed of paddle characteristics over the pH
apparatus with reference to USP range of 1.2 — 6.8.
general chapter <1092> (The • The control methods of Ertagsa
Dissolution Procedure; 5mg/100 mg & Ertagsa 15
Development and Validation). mg/100 mg have been corrected
• Submitted analytical procedure to show Paddle speed as 50 rpm
does not include test of content and Dissolution volume as 500
uniformity. ml. The analysis of commercial
batches shall be carried out
according to the revised
methods for Ertagsa
5mg/100mg & 10mg/10mg
Tablets. The actual testing of
trial batches were carried out
with 1000 ml dissolution
volume instead of 500 ml but
since both the APIs are high
solubility and the Tablets have
low disintegration time,
therefore, it can be assumed that
dissolution results would not be
significantly impacted.
• Dissolution medium and
volume in revised drug product
method is still not as per US
FDA.
11. 3.2. P.5.4 Test of content uniformity by way Firm ha submitted performance on
of Assay has not been performed the retention samples of all the three
during batch analysis. trial batches for content uniformity.
The CoAs along with related
chromatograms and work sheets
12. 3.2. P.6 • Dates of standardization of Sitagliptin USP, batch no. M-
working standard of Sitagliptin 20191228-D07-M06-04, was
& Ertugliflozin are April & received with expiry date as
August 2020, whereas the 14/02/2023. Same was standardized
product analysis has also been on 16/03/2020 against USP
performed prior to these dates. Reference Standard (Lot # R07630)
Clarification shall be submitted and declared as working standard
regarding reference standards since the results were comparable
applied for the analysis of with the RS. The re-standardization
product samples, performed date given was 15/03/2021. Same
prior to the date of lot was again tested on 27/07/2020
standardization of working due to malfunctioning of the
standards. refrigerator, in which reference and
• Submitted COA of working working standards are stored, and
standard of Ertugliflozin-LPGA since no change in potency and
does not declare the content of water contents observed therefore
LPGA and also the potency in its re-standardization date revised
accordingly as 26/07/2021 with no

terms of Ertugliflozin has not change in potency. In the
been determined. documents submitted, the revised
CoA was attached, by mistake.
Ertugliflozin, batch no. D-84-
191001, was received on
29/10/2019. Same was standardized
on 17/01/2020 against Working
Standard (B34-191001) supplied by
the manufacturer. This lot was also
qualified as Working Standard with
re-standardization date as
16/01/2021. Same lot was again
tested on 17/08/2020 due to
consumption of entire quantity of
working standard retained. A fresh
sample was taken from the
available material of batch no. D-
84-191001 and standardized with
re-standardization date as
16/08/2021 with no change in
potency. In the documents
submitted, the revised CoA was
attached, by mistake.
• Reviewed COA of working

standard has been submitted.
13. 3.2. P.8 • Submitted commercial invoice • Firm has submitted Form 3 &
for Sitagliptin phosphate Form 7 for the imported batch
monohydrate does not reveal of Sitaglitpin form M/s Fuxin
the name of manufacturer, Long Rui., China.
hence Form 3 & 7 shall be • Theoretical factor was used as
submitted. the actual contents of L-
• Justification shall be submitted pyroglutamic acid were not
for applying the theoretical determined at that time. The
factor of LPGA, instead of API has been retested (on
applying the actual potency of 15/02/2022) in order to
Ertugliflozin in working determine the potencies of
standard. Ertugliflozin L-PGA,
Ertugliflozin and L-PGA
separately to see the impact on
quantity of Ertuglifolzin L-PGA
used in trial batches. The
difference between the
theoretical and actual L-PGA
contents as declared in the CoA
from the supplier, is not that
much that could significantly
impact the quantity of
Ertugliflozin L-PGA dispensed
for small size trial batches. In
commercial batches the
quantity of Ertugliflozin L-PGA
per batch shall be calculated on
the basis of actual %age of L-
PGA content in the API

14. • You are advised to justify the According to the data of potency
quantity of “Ertugliflozin- determined in COA of
LPGA” dispensed for Ertugliflozin-LPGA, the difference
formulation of each trial, with between quantity dispensed and the
reference to the %age content of actual quantity that should have
“Ertugliflozin” in the drug been dispensed, is nominal,
substance of “Ertugliflozin- however in commercial batches the
LPGA”. quantity of Ertugliflozin L-PGA per
batch shall be calculated on the
basis of actual %age of L-PGA
content in the API in order to
achieve the desired label claim of
Ertugliflozin.
Decision: Registration Board deliberated that the selected dissolution parameters for the applied
products including apparatus, dissolution medium, volume etc are different from the parameters
described in the literature review of the product approved by US FDA. Therefore, the Board
decided to defer the applications for Ertagsa 15/100 mg Tablet & Ertagsa 5/100 mg Tablet for
submission of of stability studies data of two batches of each strength at accelerated and long term
conditions for initial and 1 month time point, wherein dissolution tests shall be performed as per
the dissolution paarmeters recommended by US FDA in the literature review of innovator drug
product i.e, Steglujan tablet.
77. Name, address of Applicant / Marketing M/s Islam Pharmaceuticals 7KM Pasrur Road
Authorization Holder Sialkot
Name, address of Manufacturing site. M/s Islam Pharmaceuticals 7KM Pasrur Road
Sialkot
☐ Importer
☐ Export sale
Evidence of approval of manufacturing Firm has submitted copy of letter No. F.1-19/2014-
facility Lic. from Secretary CLB for issuance of DML,
declaring availability of “tablet general section”.
Celezib 200mg Capsule
name
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Celecoxib ….….200mg
Pharmaceutical form of applied drug Clear and colorless solution filled in clear glass
ampoules with red and blue ACF rings and blue
color OPC mark
Pharmacotherapeutic Group of (API) Non-steroidal Anti inflammatory (NSAID)

BP
specifications
The status in reference regulatory Celecoxib 200 mg capsules, hard by M/s Macleods
authorities Pharma UK Limited, approved by MHRA of UK.
For generic drugs (me-too status) Celbex 200mg capsule by M/s Getz Pharma (Pvt)
Limited Reg. No. 028693
GMP status of the Finished product New DML was granted after inspection vide letter
manufacturer No. F. 1-19/2014-Lic (Vol-1) Dated: 29-08-2018,
including Capsule general section
Name and address of API manufacturer. M/s AARTI DRUGS LIMITED, Plot No. E-21/22,
M.I.D.C, Tarapur, Maharashtra, India
process and controls, , specifications, analytical
drug substance.
Real time: 30°C ± 2°C / 65% ± 5% RH for 60 months
months
Batches:(KM-1102215, KM-1102315, KM-
1102415)
impurities, specifications, analytical procedure and
its verification studies, batch analysis and
drug product.
Pharmaceutical equivalence and Comparative dissolution profile has been
comparative dissolution profile established against the Clebrex capsule of M/s Pfizer
in three buffer mediums i.e., ph1.2, pH 4.5 & ph 6.8
with acceptable results.
Analytical method validation/verification of Method verification studies have submitted
product including linearity, range, accuracy, precision,
specificity.

Manufacturer of API M/s AARTI DRUGS LIMITED, Plot No. E-21/22, M.I.D.C,
Tarapur, Maharashtra, India
API Lot No. Ceb/10040077
Description of Pack
Alu-PVC
Batch No. 20CRn009 21CRn001 21CRn002
Batch Size 2000 capsules 2000 capsules 2000 capsules
Date of Initiation 02-2021 02-2021 02-2021
No. of Batches 03
1. Reference of previous approval of The firm has not submitted any document.
applications with stability study data of the (New Section)
firm (if any)
2. Approval of API/ DML/GMP certificate of --
API manufacturer issued by concerned
regulatory authority of country of origin.
3 Documents for the procurement of API with • Copy of letter No.14850/2020/DRAP-AD-VIII
approval from DRAP (in case of import). (I&E) dated 16/10/2020 is submitted wherein the
permission to import different APIs including for
the purpose of test/analysis and stability studies is
granted.
• AirWay Bill No. 176-26046624
Dated: 21/12/2020
chromatograms,
Raw data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software • HPLC system digital log has been submitted
21CFR & audit trail reports on product excluding for the intial time point analysis.
testing.
accelerated)

1.6.5 Valid GMP certificate issued by the Submitted GMP certificate is of
relevant regulatory authority shall be another site of AARTI drugs ltd
(PLOT NO. W-60(B)W-61(B)W-

submitted for the drug substance 62(B)W-71(B)W-72(B)W-
manufacturer. 73(B),MIDC, Tarapur Thane,
India ), instead of the site (Plot No.
E-21/22, M.I.D.C, Tarapur,
Maharashtra, India) from which
drug substance has been imported.
3.2.S.4.2 • Submitted drug substance analytical Revised analytical method
method from M/s Islam pharma does containing details of system
not include details of system suitability parameters has been
suitability parameters in Assay test. submitted.
3.2.S.4.3 • Drug substance analytical method USP method for celecoxib do not
from M/s Aarti Drugs, declare mentions/declare the retention
retention time of Celecoxib at about time of celecoxib, the retention
27 minutes, whereas the Analytical time may vary depending on
method verification report submitted HPLC system, column condition
from M/s Islam Pharma declares the and source of chemicals.
retention time as about 16 minutes.
Clarifications hall be submitted in this
regard.
3.2. S.4.4 • The COA of drug substance • As monograph for celecoxib
manufacturer declares compliance API is available in both USP
with USP, whereas COA of drug and BP but drug product is
product manufacturer declares the only available in BP, so we
compliance with BP monograph. M/s Islam pharma chosen the
Clarification shall be submitted in this BP method and specifications.
regard. Method of analysis and
• Analytical record for the drug specification for celecoxib API
substance analysis performed by M/s are same in both USP and BP
Islam Pharma shall be submitted. monographs.
• Analytical record for the drug
substance analysis has been
submitted.
3.2.S.6 Drug substance is of USP standard As the drug substance is available
whereas reference standard of BP grade in both USP and BP and have same
has been submitted. specifications and analytical
procedure. Drug product is
available only in BP so we chosen
BP standard and used it for
analysis.
3.2.P.2.2.1 Pharmaceutical equivalence of the • Firm has submitted
applied drug shall be established with the Pharmaceutical equivalence
innovator / reference / comparator report against the celebrex
product and results of all the quality tests capsule of M/s Pfizer, wherein
(mentioned in any official pharmacopoeia instead of dissolution test of
or section 3.2.P.5.1 of this application) of batch relase, CDP study
the developed formulation and the reusulst have been submitted.
innovator / reference / comparator Submitted chromatograms
product shall be submitted. declares file created date i.e.,
18-02-2021 which is
subsequent to the acquired
date mentioned on each
chromatogram i.e., 21-01-
2021.

3.2.P.3.5 Submitted process validation protocol Process validation protocol
does not include sampling plan. including sampling plan has been
submitted.
3.2.P.5.3 Submitted analytical method verification In method verification report,
studies include details of “Montisim under section C (Method
tablet.” precision), by a typographic
mistake “montisim tablet” was
written which is corrected
3.2.P.8.3 • Documents for the procurement of • Firm has submitted copy of
API with approval from DRAP (in commercial invoice#
case of import) shall be submitted. SAMP/1002//20-21-
• Raw data sheets for complete stability 23/10/2020 frrom M/s AARTI
studies shall be submitted. drugs ltd., in the name of islam
• Submitted analytical record does not Pharma for the 2.5 Kg of
reflect the performance of system Celecoxib. The submitted
suitability test during Assay analysis invoice is not attested by
as recommended by BP monograph of DRAP I&E office.
Celcoxib capsules. • Firm has also submitted copy
• Stability studies data for 6th month of Air WayBill.
time point shall be submitted. • 6th month data of stability
• Record of Digital data logger for studies has been submitted.
temperature and humidity monitoring • Firm has performed system
of stability chambers (real time and suitability test by establishing
accelerated) shall be submitted. the RSD of standard replicates,
while BP monograph
recommends performance of
system suitability with the help
of impurity standards.
• Record of digital data logger
has been submitted.
78. Name, address of Applicant / M/s Islam Pharmaceuticals 7KM Pasrur Road
Marketing Authorization Holder Sialkot
Name, address of Manufacturing site. M/s Islam Pharmaceuticals 7KM Pasrur Road Sialkot
☐ Importer
☐ Export sale
Evidence of approval of manufacturing Firm has submitted copy of letter No. F.1-19/2014-Lic.
facility from Secretary CLB for issuance of DML, declaring
availability of “tablet general section”.

Caltis 250mg Tablet
name
Strength / concentration of drug of Each Film Coated tablet Contains:
Active Pharmaceutical ingredient (API) Clarithromycin ……. 250mg
per unit
Pharmacotherapeutic Group of (API) Antibacterial
USP
specifications
The status in reference regulatory Clarithromycin 250mg tablet, Teva Pharmaceutical,
For generic drugs (me-too status) Rithmo 250mg tablet, Sami Pharmaceuticals (Pvt.)
Limited.
GMP status of the Finished product New DML was granted after inspection vide letter No.
manufacturer F. 1-19/2014-Lic (Vol-1) Dated: 29-08-2018, including
Capsule general section
Name and address of API manufacturer. Zhejiang Better Pharmaceuticals Co., Ltd. Sanjiang
Road, Paojiang Industrial Zone, Shaoxing, Zhejiang,
P.R. China.
and controls, , specifications, analytical procedures and

comparative dissolution profile against the brand leader that is Klacid 250mg tablet by
Abbvie S.r.l Italy by performing quality tests.
CDP has been performed against the Klacid 250mg
tablet by Aesica Queenborough UK in Acid media (pH
1.0-1.2) & Acetate buffer 4.5pH and Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the acceptable
range.
Manufacturer of API Zhejiang Better Pharmaceuticals Co., Ltd. Sanjiang Road,
Paojiang Industrial Zone, Shaoxing, Zhejiang, P.R. China.
API Lot No. A022006051
Description of Pack
Batch No. 20TRn019 21TRn001 21TRn002
No. of Batches 03
applications with stability study data of (New Section)
the firm (if any)
2. Approval of API/ DML/GMP certificate --
of API manufacturer issued by concerned
3 Documents for the procurement of API • Copy of letter No.12086/2020/DRAP-AD-G (I&E)
with approval from DRAP (in case of dated 28/08/2020 is submitted wherein the
import). permission to import different APIs including
Clarithromycin for the purpose of test/analysis and
stability studies is granted.
• DHL No. 2020-11-16 XMLPI 6.2/90-1604
WAYBILL 41 0121 2102
chromatograms,
sheets etc.

5. Compliance Record of HPLC software --
testing
6. Record of Digital data logger for --
accelerated)

1.1 Differential fee of Rs. 10,000/- shall be Differential fee of Rs. 10,000/- has
submitted as per notification No.F.7- been paid vide deposit slip#
11/2012-B&A/DRAP dated 07-05-2021. 9995357177 dated 20-06-2022
1.6.5 Valid GMP certificate issued by the Firm has submitted a document for
relevant regulatory authority shall be “ Written confirmation for active
submitted for the drug substance substances exported to EU’
manufacturer. instead of GMP certificate,
Zheijiang Food & Drug
Administration.
3.2.S.4.2 Submit drug substance analytical record Submitted
performed by M/s Islam pharma.
3.2.P.2.2.1 In Pharmaceutical equivalence studies Firm has submitted Dissolution
dissolution test has not been performed as test performance in continuation to
per the USP monograph of Pharmaceutical equivalence
Clarithromycin tablets. studies.
3.2.P.3.2 • Justify the proposed quantity of • Firmhas justified proposed
Clarithromycin of 257.334mg per quantity against the actual
tablet in the batch formula against the potency of drug substance
label claim of 250mg per tablet. determined on as is basis.
• A batch formula for proposed • Commerical batch formula is
commercial batch size shall be submitted.
provided
3.2.P.3.5 Submitted process validation protocol Revised process valiation protocol
does not include sampling plan. has been submitted.
3.2.P.8.3 ➢ Submitted chromatograms of initial • Laptop attached to the HPLC
time point analysis declares file stopped working due to some
created date i.e., 18-02-2021 which is fault and its hard disc was
subsequent to the acquired date corrupted in Feb-2021 due to
mentioned on each chromatogram. which new laptop was
Clarification shall be submitted in this installed with HPLC. Previous
regard. data was recovered and
➢ Justification shall be submitted for transferred on 18-02-2021 to
calculating dissolution results based new laptop.
upon one value for standard peak area. • A new set of chromatograms
➢ Following shall be submitted: print out for DRAP submission
➢ Compliance Record of HPLC was taken after above incident
software 21CFR & audit trail reports so the chromatograms are
on product testing showing file created date as
➢ Record of Digital data logger for 18-02-2021 (which is date if
temperature and humidity monitoring saved data transfer to new
of stability chambers (real time and laptop) after the acquired date
accelerated). • HPLC system digital log has
been submitted excluding for
the intial time point analysis.

Documents for the procurement of API • Record of Digital data logger
with approval from DRAP (in case of for temperature and humidity
import) shall be submitted. monitoring of stability
chamber is submitted.
• Firm has submitted copy of
commercialinvice which is not
attested by DRAP I&E office.
Decision: Deferred for following:
• Submission of valid GMP certificate of the drug substance manufacturer issued by the
relevant regulatory authority.
• Onsight verification for the claim of the firm regarding disparity between date of
acquisition & date of file creation in the submitted chromatograms.
79. Name, address of Applicant / M/s Islam Pharmaceuticals 7KM Pasrur Road
Marketing Authorization Holder Sialkot
Name, address of Manufacturing site. M/s Islam Pharmaceuticals 7KM Pasrur Road Sialkot
☐ Importer
☐ Export sale
Evidence of approval of manufacturing Firm has submitted copy of letter No. F.1-19/2014-
facility Lic. from Secretary CLB for issuance of DML,
declaring availability of “tablet general section”.
Caltis 500mg Tablet
name
Strength / concentration of drug of Active Each Film Coated tablet Contains:
Pharmaceutical ingredient (API) per unit Clarithromycin ……. 500mg
USP
specifications
The status in reference regulatory Clarithromycin 500mg tablet, Teva Pharmaceutical,
For generic drugs (me-too status) Rithmo 500mg tablet, Sami Pharmaceuticals (Pvt.)
Limited.
GMP status of the Finished product New DML was granted after inspection vide letter No.
manufacturer F. 1-19/2014-Lic (Vol-1) Dated: 29-08-2018,
including Capsule general section

Name and address of API manufacturer. Zhejiang Better Pharmaceuticals Co., Ltd. Sanjiang
Road, Paojiang Industrial Zone, Shaoxing, Zhejiang,
P.R. China.
process and controls, , specifications, analytical
substance.
comparative dissolution profile against the brand leader that is Klacid 500mg tablet
by Aesica Queenborough UK by performing quality
tests.
CDP has been performed against the Klacid 500mg
tablet by Aesica Queenborough UK in Acid media (pH
1.0-1.2) & Acetate buffer 4.5pH and Phosphate Buffer
(pH 6.8). The values for f1 and f2 are in the acceptable
range.
Manufacturer of API Zhejiang Better Pharmaceuticals Co., Ltd. Sanjiang Road,
Paojiang Industrial Zone, Shaoxing, Zhejiang, P.R. China.
API Lot No. A022006051
Description of Pack

No. of Batches 03
applications with stability study data of (New Section)
the firm (if any)
2. Approval of API/ DML/GMP certificate --
of API manufacturer issued by
country of origin.
3 Documents for the procurement of API • Copy of letter No.12086/2020/DRAP-AD-G (I&E)
with approval from DRAP (in case of dated 28/08/2020 is submitted wherein the permission
import). to import different APIs including Clarithromycin for
the purpose of test/analysis and stability studies is
granted.
• DHL No. 2020-11-16 XMLPI 6.2/90-1604
WAYBILL 41 0121 2102
sheets etc.
5. Compliance Record of HPLC software --
testing
accelerated)

1.1 Differential fee of Rs. 10,000/- shall be
Differential fee of Rs. 10,000/- has
submitted as per notification No.F.7- been paid vide deposit slip#
11/2012-B&A/DRAP dated 07-05-2021. 94806947378 dated 20-06-2022
1.6.5 Valid GMP certificate issued by the Firm has submitted a document for
relevant regulatory authority shall be “ Written confirmation for active
submitted for the drug substance substances exported to EU’
manufacturer. instead of GMP certificate,
Zheijiang Food & Drug
Administration.
3.2.S.4.2 Submit drug substance analytical record • Submitted
performed by M/s Islam pharma. • Firm has submitted
Dissolution test performance
in continuation to

Pharmaceutical equivalence
studies.
3.2.P.2.2.1 • In Pharmaceutical equivalence studies • Laptop attached to the HPLC
dissolution test has not been stopped working due to some
performed as per the USP monograph fault and its hard disc was
of Clarithromycin tablets. corrupted in Feb-2021 due to
• In Pharmaceutical equivalence studies which new laptop was
submitted chromatograms of initial installed with HPLC. Previous
time point analysis declares file data was recovered and
created date i.e., 18-02-2021 which is transferred on 18-02-2021 to
earlier to the acquired date mentioned new laptop.
on each chromatogram. • A new set of chromatograms
print out for DRAP submission
was taken after above incident
so the chromatograms are
showing file created date as
18-02-2021 (which is date if
saved data transfer to new
laptop) after the acquired date
29-12-2020.
3.2.P.3.2 • Justify the proposed quantity of • Firm has justified proposed
Clarithromycin of 514.668mg per quantity against the actual
tablet in the batch formula against the potency of drug substance
label claim of 500mg per tablet. determined on as is basis.
• A batch formula for proposed • Commerical batch formula is
commercial batch size shall be submitted.
provided
3.2.P.3.5 Submitted process validation protocol Revised process valiation protocol
does not include sampling plan. has been submitted.
3.2.P.8.3 ➢ Submitted chromatograms of initial • Laptop attached to the HPLC
time point analysis declares file stopped working due to some
created date i.e., 18-02-2021 which is fault and its hard disc was
earlier to the acquired date mentioned corrupted in Feb-2021 due to
on each chromatogram. Clarification which new laptop was
shall be submitted in this regard. installed with HPLC. Previous
➢ Justification shall be submitted for data was recovered and
calculating dissolution results based transferred on 18-02-2021 to
upon one value for standard peak area. new laptop.
➢ Following shall be submitted: • A new set of chromatograms
➢ Compliance Record of HPLC print out for DRAP submission
software 21CFR & audit trail reports was taken after above incident
on product testing so the chromatograms are
➢ Record of Digital data logger for showing file created date as
temperature and humidity monitoring 18-02-2021 (which is date if
of stability chambers (real time and saved data transfer to new
accelerated). laptop) after the acquired date.
Documents for the procurement of API • All of three batches on stability
with approval from DRAP (in case of studies were tested on same
import) shall be submitted. day at each time point so only
one standard solution for
dissolution was injected and
calculations were made against
same one standard value.

• HPLC system digital log has
been submitted excluding for
the intial time point analysis.
• Record of Digital data logger
for temperature and humidity
monitoring of stability
chamber is submitted.
• Firm has submitted copy of
commercialinvice which is not
attested by DRAP I&E office.
• Onsight verification for the claim of the firm regarding disparity between date of
acquisition & date of file creation in the submitted chromatograms.
80. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals(Pvt.)Ltd Lahore

Authorization Holder
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals(Pvt.)Ltd ., 28km
Ferozepur Road Lahore

☐ Importer
☐ Export sale
Rivamed Tablet 20 mg
name
Strength / concentration of drug of Each Film coated Tablet Contains:
Active Pharmaceutical ingredient (API) Rivaroxaban…………….….20mg
per unit
Pharmacotherapeutic Group of (API) Rivaroxaban inhibits free FXa and prothrombinase
activity.
In-House
specifications
Proposed Pack size 10’s,14’s 20’s,28’s
The status in reference regulatory Xeralto Tablet 20mg of M/s Janssen Pharms, approved
authorities by US FDA.
For generic drugs (me-too status) Xcept of M/s Pharmevo

GMP status of the Finished product License granted on 08/04/2006 and renewed on
manufacturer 08/04/2021 General tablet section approved and GMP
certificate on 31/08/2021.
Name and address of API manufacturer. Name: Nantong Chanyoo Pharmatech Co., Ltd
Address:No.2 Tonghai Si road Yangkou chemical
industrial park rudong coastal economic development
zone nangton Jiangsu province
Batches:(RB-190401, RB-190402, RB-190403)
Pharmaceutical equivalence and Pharmaceutical equivalence & Comparative
comparative dissolution profile dissolution profile has been established against the
Xarelto tablets 10mg in three buffer mediums i.e.,
ph1.2, pH 4.5 & phH6.8 with acceptable results.
Manufacturer of API Name: Nantong Chanyoo Pharmatech Co., Ltd
Address: No.2 Tonghai Si road Yangkou chemical industrial park rudong
coastal
API Lot No. RD-RB-202003271

Description of Pack Alu-Alu blisters, each containing Blue colored, round shape, biconvex, film
(Container closure coated tablets, Plain on both sides
system) One side of blister is printed with labeling specification.

After primary packing blister is packed in specific hard card unit carton along
with Patient information leaflet
Real Ti me: 0, 3, 6 (Months)
Batch No. RD/PR20-
RD/PR20-030/T1/S2 RD/PR20-030/T1/S3
030/T1/S1
No. of Batches 03
81. Name, address of Applicant / Marketing M/s Novamed Pharmaceuticals(Pvt.) Ltd.,
Authorization Holder 28km Ferozepur Road Lahore
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals(Pvt.) Ltd.,
28km Ferozepur Road Lahore
☐ Importer
giver)
☐ Export sale
Evidence of approval of manufacturing facility License granted on 08/04/2006 and renewed on
08/04/2021 General tablet section approved and
GMP certificate on 31/08/2021.
The proposed proprietary name / brand name Rivamed 15mg Tablet
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Rivaroxaban ………15mg
Pharmacotherapeutic Group of (API) Rivaroxaban inhibits free FXa and
prothrombinase activity.
Reference to Finished product specifications In-House
The status in reference regulatory authorities Xeralto Tablet 10mg of M/s Janssen Pharms,
approvedby US FDA.

GMP status of the Finished product GMP certificate granted on 31/08/2021.
manufacturer
Name and address of API manufacturer. M/s Nantong Chanyoo Pharmatech Co., Ltd
Address:No.2 Tonghai Si road Yangkou
chemical industrial park rudong coastal
economic development zone nangton Jiangsu
province
submitted.
substance.
Real time: 30°C ± 2°C / 65% ± 5% RH for 24
months
months
Batches:(KM-1102215, KM-1102315, KM-
1102415)
Pharmaceutical equivalence and comparative Pharmaceutical requivalence & Comparative
dissolution profile dissolution profile has been established against
the Xarelto tablets 10mg in three buffer
mediums i.e., ph1.2, pH 4.5 & ph 6.8 with
acceptable results.
specificity.

Address: No.2 Tonghai Si road Yangkou chemical industrial
park rudong coastal

Description of Pack Alu-Alu blisters
Batch No. RD/PR20- RD/PR20- RD/PR20-
029/T1/S1 029/T1/S2 029/T1/S3
No. of Batches 03
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Rivamed 10mg Tablet
Pharmaceutical ingredient (API) per unit Rivaroxaban ………10mg

approved by US FDA.
manufacturer
province
submitted.
substance.
months
months
Batches:(KM-1102215, KM-1102315, KM-
1102415)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence & Comparative
the Xarelto tablets 10mg in three buffer
mediums i.e., ph1.2, pH 4.5 & ph 6.8 with
acceptable results.

specificity.
park rudong coastal

Description of Pack Alu-Alu blisters, each containing Yellow colored, round shape,
(Container closure system) biconvex, film coated tablets, Plain on both sides
One side of blister is printed with labeling specification.
After primary packing blister is packed in specific hard card unit
carton along with Patient information leaflet
028/T1/S1 028/T1/S2 028/T1/S3
No. of Batches 03
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Rivamed 2.5mg Tablet

Pharmaceutical ingredient (API) per unit Rivaroxaban ……… 2.5mg
approvedby US FDA.
For generic drugs (me-too status) Xcept of M/s Pharmevo (Reg No: 076157)
manufacturer
province
submitted.
manufacturing process and controls, ,
substance.
months
months
Batches:(KM-1102215, KM-1102315, KM-
1102415)

Pharmaceutical equivalence and comparative Pharmaceutical requivalence & Comparative
the Xarelto tablets in three buffer mediums i.e.,
ph1.2, pH 4.5 & ph 6.8 with acceptable results.
specificity.
park rudong coastal

Description of Pack Alu-Alu blisters, each containing Yellow colored, round shape,
(Container closure system) biconvex, film coated tablets, Plain on both sides
One side of blister is printed with labeling specification.
After primary packing blister is packed in specific hard card unit
carton along with Patient information leaflet
027/T1/S1 027/T1/S2 027/T1/S3
No. of Batches 03
1. Reference of previous approval of applications Not submitted.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate Nantong Chemical &
manufacturer issued by concerned regulatory Medical Industry Association has been
authority of country of origin. submitted valid upto 05-05-2022.
3 Documents for the procurement of API with --
approval from DRAP (in case of import).

chromatograms,
5. Compliance Record of HPLC software 21CFR & Submitted


1.5.6 The said section declares Pharmacopoeial Since the BP monograph of the
reference as In-Hose, whereas BP Rivaroxaban was not available at
monograph is available for applied the time of Product Development
product. So the specification and analytical
method follows In-House standard
as per FDA guideline and same
method has been validated. Both
the Raw material and Product is
Included in recent volume of BP
1.6.5 Valid GMP certificate issued by the GMPcertificate from nanytong
relevant regulatory authority shall be chemical & medical Industry
submitted for the drug substance Association valid till 21-02-2026
manufacturer. has been submitted.
3.2.S.4.1 • The specifications and analytical • Since the BP monograph of the
procedure submitted from drug Rivaroxaban was not available
substance manufacturer is of In-house at the time of Product
standard whereas BP monograph is Development So the
available for applied formulation. specification and analytical
• Copies of the Drug substance method follows In-House
specifications and analytical standard FDA guideline and
procedures used for routine testing of same method has been
the Drug substance / by Drug Product validated
manufacturer is required. Analytical method validation
studies were performed for In-
House method as the BP
Monograph was not available for
applied formulation till its
development and submission.
3.2.S.4.3 Analytical method verification studies Analytical method validation
shall be submitted for BP monograph of studies were performed for In-
Rivaroxaban, performed by M/s House method as the BP
Novamed. Monograph was not available for
development and submission
3.2.S.5 COA of primary / secondary reference COA of working standard
standard, applied by M/s Novamed for submitted.
drug substance analysis, including source
and lot number shall be provided.
3.2.P.2.2.1 Dissolution test has not been performed in Comparative dissolution profile
Pharmaceutical equivalence studies. against the Innovator Xeralto was
performed and Pharmaceutical
equivalence was established
Through CDP and rest of the
testing parameters are covered
under PE testing
3.2.P.5.1 • Drug product specifications and • BP Since the BP monograph of
analytical procedures have been the Rivaroxaban was not
referred as In-house , where as BP available at the time of Product

monograph is available fro Development So the
“Rivaroxaban tablets”. specification and analytical
• BP monograph of Rivaroxaban tablets method follows In-House
specify limits of Assay test as 95.0% - standard FDA guideline and
105.0%, whereas firm has applied same method has been
limits of 90.0% - 110.0%. validated. Both the Raw
Justification shall be submitted in this material and Product is Included
regard. in recent volume of BP.
• Test of content uniformity has not • Since the BP monograph of the
been included in the drug product Rivaroxaban was not available at
specifications. the time of Product Development
So the specification and
analytical method follows In-
House standard FDA guideline
and assay limit was set as 90-
110% and same method has been
validated.
• The Content uniformity has been

performed and results are
submitted.
3.2.P.5.2 • Submitted analytical procedure for • Since the BP monograph of the
Assay & Dissolution test is not as per Rivaroxaban was not available
the BP monograph of Rivaroxaban at the time of Product
tablet. Development So the
• Limits for dissolution test mentioned specification and analytical
in analytical procedure (NLT 80% (Q) method & Dissolution follows
in 45 minutes)) is not as per the BP In-House standard based on
monograph (NLT 80% (Q) in 30 FDA guideline and same
minutes)). method has been validated.
• The limits for dissolution is as
per In-house Standard since
the BP monograph was not
available at the time of its
3.2.P.5.3 Analytical method verification studies Analytical method validation
shall be submitted for BP monograph of studies were performed for In-
Rivaroxaban tablet, performed by M/s House method as the BP
Novamed. Monograph was not available for
3.2.P.5.4 • Submitted batch analysis record does • The Content uniformity has
not include test of content uniformity. been performed and results
• Submitted batch analysis record are submitted.
reflects performance of Dissolution • The dissolution test is
test with specifications different from performed as per In-house
BP monograph. standard based on FDA
guideline as the BP method is
not available at the time of its
development.
3.2.P.8.3 • Documents for the procurement of Copy of commercial invoice#
API with approval from DRAP (in CY20121 attested by AD DRAP
case of import) shall be submitted. I&E Lahore dated 30-07-2020fo

• Stability studies have not been rimport of 1 Kg of Rivaroxaban ha
conducted according to the BP sbeen submitted.
monograph of Rivaroxaban Tablet.
Since the BP monograph of the
Justification shall be submitted in this
regard. Rivaroxaban was not available at
the time of Product Development
So the specification follows In-
House standard based on FDA
guideline and stability studies
performed accordingly.
th
Decision of 320 meeting: Registration Board approved Rivamed Tablet 20 mg, Rivamed 15mg
Tablet, Rivamed 10mg Tablet & Rivamed 2.5mg Tablet with BP specifications.
• The firm shall submit fee of Rs. 7500/- for each strength for correction/pre-approval change in
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.

☐ Importer
☐ Export sale
Apixo Tablet 2.5 mg
name
Active Pharmaceutical ingredient (API) Apixaban ….…. 2.5mg
per unit
Pharmacotherapeutic Group of (API) Apixaban (Anticoagulant and direct inhibitor of
factor Xa.
In-House
specifications
Proposed Pack size 10’s,20’s,30’s
The status in reference regulatory Eliquis Tablet 2.5mg,
authorities Company: Bristol Myers Squibb,USA

For generic drugs (me-too status) Apixaget 2.5mg by Getz Pharma
Reg No: 105247
Name and address of API manufacturer. Name: Changzhou Pharmaceuticals Factory
Address:518 Laodong East Road, Changzhou,
Jianngsu Province, China.
substance
Batches:(ZSAP171104,ZSAP171105,ZSAP171106)
product.
comparative dissolution profile against the brand leader that is Eliquis Tablet 2.5mg
by performing quality tests (Identification, Assay,
Dissolution, pH).
CDP was applicable and has been submitted.
Analytical method validation/verification Method validation studies have submitted including
of product linearity, range, accuracy, precision, specificity,
robustness and Limit of Quantification.
Manufacturer of API Name: Changzhou Pharmaceuticals Factory
Address: 518 Laodong East Road,Changzhou,Jianngsu Province, China.
API Lot No. AP191204

Description of Pack Alu-PVC blisters, each containing 10 Green colored, round shape, biconvex,
(Container closure film coated tablets, Plain on both sides
Batch No. RD/PR20-
RD/PR20-001/T1/S2 RD/PR20-001/T1/S3
001/T1/S1
No. of Batches 03
1. Reference of previous approval of The firm has submitted copy of Last inspection Report
applications with stability study data of conducted on 24/01/2018 (Daclatasvir), 06/03/2017
the firm (if any) (Sofosbuvir)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate issued by CFDA, People’s
of API manufacturer issued by concerned republic of china Changzhou Jiangsu valid till
regulatory authority of country of origin. 21/10/2021
3. Documents for the procurement of API Copy of letter No.6139/2020/DRAP-AD-CD(I&E)
import). to import API Apixaban for the purpose of test/analysis
and stability studies is granted.
AD I&E (Lahore) Attested invoice CYI20200
Dated.28/05/2020 is also submitted.
chromatograms,
sheets etc.
testing
accelerated)

1.6.5 Valid GP certificate issued by relevant Firm has submitted GMP certificate
regulatory authority shall be submitted, valid upto 15-11-2024, issud by the
for drug substance manufacturer. Jiangsu Changzhou Drug
Administration, which is not a state

or provincial level regulatory
authority.
3.2.P.2.2.1 Dissolution test has not been • CDP againt the Innovator was
performed in Pharmaceutical performed and Pharmaceutical
Equivalences studies. equivalence was established
Clarification shall be submitted for through CDP and rest of the
declaring dissolution results above testing parameters are covered
85% in CDP studies, without using under PE testing.
surfactant i.e., SLS in dissolution • Surfactant SLS is mistakenly
medium. not mentioned n CDP reports
while it is used in dissolution
medium, which is evident from
testing method.
3.2.P.5.1 • Innovator product approved by US • Firm has referred to the EM
FDA has recommended dissolution Aassesment report for Apixaban
limits of NLT Q in 30minutes tablet wherein resulst of 80%
whereas firm has proposed dissolved in 45 minutes have
dissolution time of 45 minutes. been mentioned for the
• Test of content uniformity has not coparative profile of refernec
been included in finished drug eand test product, whereas
product specifications. observation was made regarding
dissolution test limits
recommended for batch release
by US FDA for innovator
product.
• Firm has submitted results for
the performance of content
uniformity test.

☐ Importer
☐ Export sale

Apixo Tablet 5 mg
name
Active Pharmaceutical ingredient (API) Apixaban ….…. 5mg
per unit
Pharmacotherapeutic Group of (API) Apixaban (Anticoagulant and direct inhibitor of
factor Xa.
In-House
specifications
Proposed Pack size 10’s,20’s,30’s
The status in reference regulatory Eliquis Tablet 2.5mg,
authorities Company: Bristol Myers Squibb,USA
For generic drugs (me-too status) Apixaget 2.5mg by Getz Pharma
Reg No: 105247
Name and address of API manufacturer. Name: Changzhou Pharmaceuticals Factory
Address:518 Laodong East
Road,Changzhou,Jianngsu Province,China.
substance
Batches:(ZSAP171104,ZSAP171105,ZSAP171106)

product.
Pharmaceutical equivalence and Pharmaceutical Equivalence & CDP have been
comparative dissolution profile established against the Eliquis Tablet 5mg.
Analytical method validation/verification Method validation studies have submitted including
of product linearity, range, accuracy, precision, specificity,
robustness.
Manufacturer of API Name: Changzhou Pharmaceuticals Factory
Address: 518 Laodong East Road,Changzhou,Jianngsu Province, China.
API Lot No. AP191204
Description of Pack Alu-PVC blisters, each containing 10 Green colored, round shape, biconvex,
(Container closure film coated tablets, Plain on both sides
Batch No. RD/PR20-
RD/PR20-002/T2/S2 RD/PR20-002/T2/S3
002/T2/S1
No. of Batches 03
1. Reference of previous approval of The firm has submitted copy of Last inspection Report
applications with stability study data of the conducted on 24/01/2018 (Daclatasvir), 06/03/2017
firm (if any) (Sofosbuvir)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate issued by CFDA, People’s
of API manufacturer issued by concerned republic of china Changzhou Jiangsu valid till
regulatory authority of country of origin. 21/10/2021
3. Documents for the procurement of API Copy of letter No.6139/2020/DRAP-AD-CD(I&E)
import). to import API Apixaban for the purpose of test/analysis
and stability studies is granted.
AD I&E (Lahore) Attested invoice CYI20200
Dated.28/05/2020 is also submitted.
chromatograms,
sheets etc.

testing
accelerated)

1.6.5 Valid GMP certificate issued by Firm has submitted GMP certificate
relevant regulatory authority shall
valid upto 15-11-2024, issud by the
be submitted, for drug substance Jiangsu Changzhou Drug
manufacturer. Administration, which is not a state or
provincial level regulatory authority.
3.2.P.2.2.1 Dissolution test has not been • CDP againt the Innovator was
performed in Pharmaceutical performed and Pharmaceutical
Equivalences studies. equivalence was established
Clarification shall be submitted for through CDP and rest of the
declaring dissolution results above testing parameters are covered
85% in CDP studies, without using under PE testing.
surfactant i.e., SLS in dissolution • Surfactant SLS is mistakenly not
medium. mentioned n CDP reports while it
is used in dissolution medium,
which is evident from testing
method.
3.2.P.5.1 • Innovator product approved by • Firm has referred to the EMA
US FDA has recommended Aassesment report for Apixaban
dissolution limits of NLT Q in tablet wherein resulst of 80%
30minutes whereas firm has dissolved in 45 minutes have been
proposed dissolution time of 45 mentioned for the coparative
minutes. profile of refernec eand test
• Test of content uniformity has product, whereas observation was
not been included in finished made regarding dissolution test
drug product specifications. limits recommended for batch
release by US FDA for innovator
product.
• Firm has submitted results for the
performance of content
uniformity test.
86. Name, address of Applicant / M/s SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off Hub
Marketing Authorization Holder River Road, S.I.T.E. Karachi.
Name, address of Manufacturing site. M/s SAMI Pharmaceuticals (Pvt.) Ltd. F-95, Off Hub
River Road, S.I.T.E. Karachi.

☐ Importer
☐ Export sale
OMDIN 100mcg/ml Injection
name
Strength / concentration of drug of Each ml contains:
Active Pharmaceutical ingredient (API) Dexmedetomidine hydrochloride equivalent to
per unit Dexmedetomidine ……. 100mcg
Pharmaceutical form of applied drug Clear colorless solution for injection
Pharmacotherapeutic Group of (API) Hypnotics and Sedatives
ATC Code: N05CM18

USP Specification
specifications
Proposed Pack size 2ml; 1’s, 2’s, 5’s
PRECEDEX 100mcg/ml Injection approved by USFDA
authorities
For generic drugs (me-too status) Precidex 100mcg/ml Injection by M/s Brookes Pharma
(Reg.#088249)
manufacturer
Name and address of API manufacturer. M/s Jiangsu Hengrui Medicine Co., Ltd. 22 Jinqiao
Road, Dapu Industrial park, Economical &
Technological Development Zone Lianyungang,
Jiangsu 222002, China
specifications, analytical procedures and its verification,
stability studies of drug substance and drug product is
submitted.

Batches: (6601506012, 6601507012, 6601507022)
comparative dissolution profile against Precidex 100mcg/ml Injection by M/s Brookes
Pharma by performing quality tests (Appearance, pH,
Assay, impurity profiling, BET, sterility test).
CDP is not applicable
Analytical method Method verification studies have submitted including
validation/verification of product linearity, accuracy, precision (repeatability), specificity.
Manufacturer of API M/s Jiangsu Hengrui Medicine Co., Ltd.
API Lot No. 6601908012
Description of Pack
(Container closure Unprinted Clear ampoule 2ml USP type 1
system)
Batch Size 2000 ml 2000 ml 2000 ml
No. of Batches 03
1. Reference of previous approval of Reference of last onsite panel inspection for instant
applications with stability study data of dosage form conducted during last two years i.e. IBRUO
the firm (if any) (Ibuprofen) 800mg/8ml injection which was presented in
289th meeting of the registration board & hence
approved & registered by registration board
Date of inspection: 28th January 2019
The inspection report confirms following points
• The HPLC software is 21CFR Compliant

2. Approval of API/ DML/GMP certificate GMP certificate no. JS20191012 of M/s Jiangsu Hengrui
of API manufacturer issued by Medicine Co., Ltd.is valid until 27/02/2024 issued by
concerned regulatory authority of Jiangsu Drug Administration, China Food and Drug
country of origin. Administration
3. Documents for the procurement of API Copy of commercial invoice (Invoice#19QN265 dated
with approval from DRAP (in case of 14-2-2020 with received quantity of 4gm) for the
import). purchase of Dexmedetomidine HCl from M/s Jiangsu
Hengrui Medicine Co., Ltd. with attestation of DRAP
dated 27-02-2020
4. Data of stability batches will be Firm has submitted complete record of testing of all
supported by attested respective batches along with chromatograms, raw data sheets,
documents like chromatograms, Raw COA and summary data sheets
etc.
testing
accelerated)

3.2.P.2.2.1 Pharmaceutical equivalence • As innovator product is not available in
studies have not been performed Pakistan, therefore, we tried to arrange the
against Innovator. innovator product from outside the Pakistan,
however since this product is only used in
Hospitals/Institutions before and/or during
surgical and other procedures and therefore
not available at Pharmacy level; we
conducted, comparative analysis with the
comparator product
•As per the DRAP's "Frequently Asked
Questions" uploaded on its official website, it
has been permitted by the Authority that in
case of non-availability of the innovator pack,
comparative analysis can be performed with
the brand leader/generic product
(Reference document attached)
•It is further submitted that as per WHO
technical report Series No. 902, 2002:
"If the innovator product is not available on

the local market, pharmaceutical companies
should obtain from the market a product that
is the best representative innotao rproduct fro

mth epoint of view of its quality, safety &
efficacy.”
Hence, due to non-availability of the

innovator pack in the local market, we
conducted the comparative analysis with
comparator product .i.e. PRECIDEX
(Dexmedetomidine) 100mcg/ml Injection
(Reg. No. 088249} being manufactured by
M/s. Brookes Pharma, Karachi
3.2.P.5.2 Exact Limits of Endotoxin test Firm has submitted revised test method with
shall be mentioned instead of numerical limits of Endotoxin test.
referring to the general USP
chapter
3.2.P.5.4 Submitted COA does not Firm has submitted revised COA indicating
include performance of test of the extractable volume with declaration that
“Fill volume”. we have performed this test however was not
mentioned in the COA since it's an in-process
test.
87. Name, address of Applicant / M/s Leama Chemi Pharma Pvt Ltd. 37-A, Hayatabad
Marketing Authorization Holder Industrial Estate, Peshawar
Name, address of Manufacturing site. M/s Gray’s Pharmaceutical Plot # 2, Street # N-3,
National Industrial Zone, Rawat Islamabad
☐ Importer
☒ Is involved in none of the above (contract giver)
☐ Export sale
Limaxone 1g IV/IM Injection
name
Active Pharmaceutical ingredient Ceftriaxone sodium eq. to Ceftriaxone 1gm
(API) per unit
Pharmaceutical form of applied drug Almost white to off white colored powder filled in glass
vial.
USP
specifications

MHRA approved
authorities
For generic drugs (me-too status) Topcef 1g Injection of M/s. Pride Pharmaceuticals
025878
GMP status of the Finished product GMP certificate issued based upon inspection conduct 5-
manufacturer 5-17, valid upto 4-5-18.
Name and address of API manufacturer. M/s. Qilu Antibiotics Pharmaceutical CO. Ltd. No. 849
Dongjia Town Licheng District Jinan City China.
physical form, manufacturers,
Characterization, specifications, analytical procedures
and its validation, batch analysis and justification of
system and stability studies of drug substance. The firm
has summarized
information of drug product including its description,
composition, pharmaceutical development, manufacture,
manufacturing process and process control, process
validation protocols, control of excipients, control of drug
validation/verification of analytical procedures, batch
standard or materials, container closure system and
stability.
Module III (Drug Substance) Firm has submitted detailed data for both drug substance
description of
drug substance.
Stability studies Firm has submitted stability study data of 3 batches of
40 O ± 2 O C /75% ± 5% RH for 6 months. The real time
stability data is conducted at 30OC ± 2 O C / 65% ± 5%
RH for 36 months.
impurities, specifications, analytical procedure (including
dissolution testing at acidic and buffer medium) and its

Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence against
comparative dissolution profile the product Rocephin Injection 1g IM.
validation/verification of product linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s. Qilu Antibiotics Pharmaceutical CO. Ltd. No. 849 Dongjia Town
Licheng District Jinan City China.
API Lot No. 0151NJ81HE
Description of Pack
(Container closure Glass vial
system)
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 124 125 126
Batch Size 10,000 Vials 12170 Vials 12170 Vials
No. of Batches 03
1. Reference of previous approval of NA
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate of M/s. Qilu Antibiotics Pharmaceutical
of API manufacturer issued by CO. Ltd. No. 849 Dongjia Town Licheng District Jinan
concerned regulatory authority of City China. issued by State food and drug administration
country of origin. china, valid Up to 5-6-2023.
3. Documents for the procurement of API Firm has submitted attested copy of invoice
with approval from DRAP (in case of (invoice#JTRF210117-MQ)
import).

etc.
testing
6. Record of Digital data logger for Firm has submitted record of data logger for temperature
temperature and humidity monitoring of and humidity monitoring of real time and accelerated
stability chambers (real time and stability chambers.
accelerated)
Evaluation by PEC:

• The applied formulation to be manufactured by M/s Gray’s Pharmaceuticals, Rawat have already
been granted approval vide letter No.F.316-RB/2022 (PR-II) dated 26th May 2022. The case of
the applied formulation of M/s Gray’s Pharmaceuticals, Rawat was considered by Registration
Board in its 316th meeting based on the data of same batches of drug product as submitted in the
instant case. The details of the already considered product in 316th meeting are as follows:
Applicant firm M/s Akson Pharmaceuticals, Plot No.9-B/ 1& 2, Old,

Industrial Estate New Mirpur City, Azad Jammu and
Kashmir
Manufacturer firm M/s Gray’s Pharmaceuticals, Plot #2, Street # N-3, National
Industrial Zone, Rawat-Pakistan
Brand Name Trophin Injection 1 gm IV/IM later approved as Trophin
Injection 1 gm IV
Batch No. of drug product 124, 125, 126
Case No. 3
Registration Board 316th meeting of Registration Board
meeting
• The case was discussed in 316th meeting wherein Registration Board deliberated that as case
pertains to contract manufacturing of already registered drug products thus authorized its
Chairman for approval of contract manufacturing permission after rectification of identified
shortcomings and product specific inspection.
• After 316th meeting of Registration Board the case was considered in light of rectifications of
identified shortcomings (as identified in minutes of 316th meeting) and product inspection report,
and accordingly after approval by Chairman Registration Board, letter for approval for the grant
of contract manufacturing permission vide letter No.F.316-RB/2022 (PR-II) dated 26th May 2022
was issued to M/s Akson Pharmaceuticals was issued wherein the contract manufacturer was M/s
Gray’s Pharmaceuticals, Rawat.
• Firm has applied for both IV/IM injection however the data of contract manufacturer i.e.
M/s Gray’s Pharmaceuticals already considered and approved in 316th meeting was for 1gm
IV Injection.
Decision of 320th meeting: Approved with IV route of administration.
• Registration Board further decided that registration letter will be issued after on-site inspection
of capacity assessment of M/s Gray’s Pharmaceutical Plot # 2, Street # N-3, National Industrial
Zone, Rawat Islamabad, for the manufacturing & Quality control facility.
88. Name, address of Applicant / Marketing M/s Leama Chemi Pharma Pvt Ltd. 37-A,
Authorization Holder Hayatabad Industrial Estate, Peshawar
Name, address of Manufacturing site. M/s Gray’s Pharmaceutical Plot # 2, Street # N-3,
☐ Importer
☐ Export sale

Limaxone 250mg IV Injection
name
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium eq. to Ceftriaxone 250mg
Pharmaceutical form of applied drug Almost white to off white colored powder filled in
glass vial.
USP
specifications
MHRA approved
authorities
For generic drugs (me-too status) Topcef Injection of Ceftriaxone Sodium by Pride
Pharmaceuticals 025876
GMP status of the Finished product GMP certificate issued based upon inspection conduct
manufacturer 5-5-17, valid upto 4-5-18.
Name and address of API manufacturer. M/s. Qilu Antibiotics Pharmaceutical CO. Ltd. No.
849 Dongjia Town Licheng District Jinan City China.
template.
Characterization, specifications, analytical procedures
system and stability studies of drug substance. The
firm has summarized
information of drug product including its description,
composition, pharmaceutical development,
analytical procedures, validation/verification of
Module III (Drug Substance) Firm has submitted detailed data for both drug
substance data related to nomenclature, structure,
manufacturers, description of

Stability studies Firm has submitted stability study data of 3 batches of
at 40 O ± 2 O C /75% ± 5% RH for 6 months. The real
time stability data is conducted at 30OC ± 2 O C / 65%
± 5% RH for 36 months.
(Batch No. 60155GJ81H-C, 60156GJ81H-C,
6015GJ81H-C)
product.
Pharmaceutical equivalence and Firm has performed pharmaceutical equivalence
comparative dissolution profile against the product Oxidil 250mg Injection IV.
Manufacturer of API M/s. Qilu Antibiotics Pharmaceutical CO. Ltd. No. 849 Dongjia Town
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 103 115 120
Batch Size 5,000 packs 5,000 packs 5,000 packs
No. of Batches 03
applications with stability study data of the
firm (if any)
2. Approval of API/ DML/GMP certificate of GMP certificate of M/s. Qilu Antibiotics
API manufacturer issued by concerned Pharmaceutical CO. Ltd. No. 849 Dongjia Town
regulatory authority of country of origin. Licheng District Jinan City China. issued by State
food and drug administration china, valid Up to 5-6-
2023.
import).

testing
accelerated)
Evaluation by PEC:
• The applied formulation to be manufactured by M/s Gray’s Pharmaceuticals, Rawat have already
been granted approval vide letter No.F.316-RB/2022 (PR-II) dated 26th May 2022. The case of
the applied formulation of M/s Gray’s Pharmaceuticals, Rawat was considered by Registration
Board in its 316th meeting based on the data of same batches of drug product as submitted in the
instant case. The details of the already considered product in 316th meeting are as follows:

Kashmir
Manufacturer firm M/s Gray’s Pharmaceuticals, Plot #2, Street # N-3, National
Industrial Zone, Rawat-Pakistan
Brand Name Trophin injection 250mg IV
Case No. 7
meeting
•The case was discussed in 316th meeting wherein Registration Board deliberated that as case
pertains to contract manufacturing of already registered drug products thus authorized its
Chairman for approval of contract manufacturing permission after rectification of identified
shortcomings and product specific inspection.
• After 316th meeting of Registration Board the case was considered in light of rectifications of
identified shortcomings (as identified in minutes of 316th meeting) and product inspection report,
and accordingly after approval by Chairman Registration Board, letter for approval for the grant
of contract manufacturing permission vide letter No.F.316-RB/2022 (PR-II) dated 26th May 2022
was issued to M/s Akson Pharmaceuticals was issued wherein the contract manufacturer was M/s
Gray’s Pharmaceuticals, Rawat.
Decision of 320th meeting: Approved with IV route of administration.
• Registration Board further decided that registration letter will be issued after on-site inspection
of capacity assessment of M/s Gray’s Pharmaceutical Plot # 2, Street # N-3, National Industrial
Zone, Rawat Islamabad, for the manufacturing & Quality control facility.
89. Name, address of Applicant / M/s Quaper Pharmaceuticals Plant 26-A Small
Marketing Authorization Holder Industrial Esatte Lahore Road Sargodha
Name, address of Manufacturing site. M/s Nicholas Pharmaceuticals, plot # 34, St # SS-02
National industrial Zone Rawat Islamabad

☐ Importer
Copy of agreement for contract manufacturing of
pharmaceutical products between contract giver and
acceptor dated 26-06-2021 is submitted.
GMP status of the firm Nicholas pharma: Firm has submitted copy of GMP
certificate dated 25-02-2020 issued on the basis of
inspection dated 28-01-2020
Evidence of approval of manufacturing Firm has submitted copy of letter of issuance of DML
facility No 000886 of M/s Nicholas Pharma Islamabad dated
29-08-2018 specifying dry powder injection
(carbapenem) section.
☐ Export sale
The proposed proprietary name / brand Q-NEM 500mg Injection
name
Pharmaceutical ingredient (API) per unit Meropenem trihydrate eq to meropenem……500mg
(blended with sodium carbonate)
Pharmaceutical form of applied drug White to off white powder filled in clear glass vials
Pharmacotherapeutic Group of (API) Carbapenem antibiotic
specifications
The status in reference regulatory Merrem Injection (USFDA Approved)
authorities
For generic drugs (me-too status) Merrem Injection of Global Pharmaceuticals
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630
RIICO Industrial Area bhiwadi District Alwar
Rajasthan, India.
drug product.

(Conditions & duration of Stability of drug substance at both accelerated as well as real
studies) time conditions. The accelerated stability data is
conducted at 40°C ± 2°C / 75% ± 5% RH for 6
months. The real time stability data is conducted at
30°C ± 2°C / 75 ± 5% RH for 36 months.
Comparative Dissolution Profile equivalence for the quality tests for their product
against Meronem500mg Injection of Pfizer Pakistan
Ltd manufactured by ACS Dobfar Italy.
Manufacturer of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial Area
bhiwadi District Alwar Rajasthan, India.
API Lot No. MRPS/062/18
Description of Pack
system)
Batch No. Noopem Noopem Noopem
Injection 001 Injection 001 Injection 001
Batch Size 7,000 Vials 7,000 Vials 7,000 Vials
No. of Batches 03

1. Reference of previous approval of No previous inspection of the firm has been conducted
applications with stability study data of the for verification of stability study data.
firm (if any)
2. Approval of API/ DML/GMP certificate of
Copy of GMP certificate of M/s Rajasthan Antibiotics
API manufacturer issued by concerned Ltd. Plot No. 619 & 630 RIICO Industrial Area
bhiwadi District Alwar Rajasthan, India. (Certificate#
DC/A-I/WHO-GMP/2022/440) issued by Drug
Control Organization Government of Rajastan valid
upto 26-02-2023 is submitted
3. Documents for the procurement of API with Firm has submitted following:
approval from DRAP (in case of import). • Copy of Form 5 (License to Import) dated 30-04-
2019
• Commercial invoice (invoice# RALIE/19-20/003)
Dated: 12-04-2019 cleared by DRAP Islamabad
office dated 30-04-2019 specifying import of 20Kg
Meropenem Sterile for Injection(Batch#
MRPS/062/18).
4. Data of stability batches will be supported Firm has submitted Stability data along-with HPLC
by attested respective documents like chromatograms and raw data sheets.
5. Compliance Record of HPLC software We have performed stability testing as per USP
21CFR & audit trail reports on product specifications. We have also verified the USP method.
testing The analysis was performed using HPLC system
which is 21 CFR compliant. The certificate of
compliance is also submitted by the firm.
accelerated)
Evaluation by PEC:
• The applied product to be manufactured by M/s Nicholas Pharmaceuticals have already been
approved by Registration Board in its 307th and 316th meeting based on the data of same batches
of drug product as submitted in the instant case. The details of the already approved product in
316th meeting are as follows:
Applicant firm M/s Jinnah Pharmaceutical (Pvt) Ltd. 13-Km, Lahore Road
Multan
Manufacturer firm M/s Nicholas Pharmaceuticals, plot # 34, St # SS-02
Brand Name MEROCIN 500mg Injection
Batch No. of drug product P5001 (8,600 vials), P5002 (8,600vials), P5003 (10,630
vials)
Case No. 608
Registration Board 316th meeting of Registration Board held on (15-18 March,
• meeting 2022)

90. Name, address of Applicant / M/s Quaper Pharmaceuticals Plant 26-A Small
Marketing Authorization Holder Industrial Esatte Lahore Road Sargodha
☐ Importer
Evidence of approval of manufacturing Firm has submitted copy of letter of issuance of DML
facility No 000886 of M/s Nicholas Pharma Islamabad dated
☐ Export sale
The proposed proprietary name / brand Q-Nem 1g Injection
name
Pharmaceutical ingredient (API) per unit Meropenem trihydrate eq to meropenem …… 1g
specifications
authorities
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630
RIICO Industrial Area bhiwadi District Alwar
Rajasthan, India.

drug product.
(Conditions & duration of Stability of drug substance at both accelerated as well as real
studies) time conditions. The accelerated stability data is
30°C ± 2°C / 75 ± 5% RH for 36 months.
against Meronem 1g Injection of Pfizer Pakistan Ltd
manufactured by ACS Dobfar Italy.
Manufacturer of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial Area
bhiwadi District Alwar Rajasthan, India.
Description of Pack
system)
Batch No. Noopem Noopem
Jeronum Injection 001
Injection 001 Injection 002

No. of Batches 03
1. Reference of previous approval of No previous inspection of the firm has been conducted
applications with stability study data of the for verification of stability study data.
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate of M/s Rajasthan Antibiotics
API manufacturer issued by concerned Ltd. Plot No. 619 & 630 RIICO Industrial Area
regulatory authority of country of origin. bhiwadi District Alwar Rajasthan, India. (Certificate#
DC/A-I/WHO-GMP/2022/440) issued by Drug
Control Organization Government of Rajastan valid
approval from DRAP (in case of import). • Copy of Form 5 (License to Import) dated 30-04-
2019
• Commercial invoice (invoice# RALIE/19-20/003)
Dated: 12-04-2019 cleared by DRAP Islamabad
office dated 30-04-2019 specifying import of 20Kg
Meropenem Sterile for Injection(Batch#
MRPS/062/18).
4. Data of stability batches will be supported Firm has submitted Stability data along-with HPLC
by attested respective documents like chromatograms and raw data sheets.
21CFR & audit trail reports on product specifications. We have also verified the USP method.
testing The analysis was performed using HPLC system
which is 21 CFR compliant. The certificate of
compliance is also submitted by the firm.
accelerated)
Evaluation by PEC:
• The applied product to be manufactured by M/s Nicholas Pharmaceuticals have already been
approved by Registration Board in its 307th and 316th meeting based on the data of same batches
of drug product as submitted in the instant case. The details of the already approved product in
316th meeting are as follows:
Applicant firm M/s Jinnah Pharmaceutical (Pvt) Ltd. 13-Km, Lahore Road
Multan
Brand Name MEROCIN 1g Injection
Batch No. of drug product Noopem Injection 001, Noopem Injection 002, Jeronum
Injection 001
Case No. 821
meeting

91. Name, address of Applicant / M/s Aptcure Pvt Ltd. 8- Pharma City, 30 km Multan
Marketing Authorization Holder Road, Lahore
Link Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore
☐ Importer
☐ Export sale
Greeninject 50mg/ml Injection
name
Strength / concentration of drug of Each Vial Contains:
Active Pharmaceutical ingredient (API) Iron as Ferric Carboxymaltose…50mg/ml
per unit
Pharmaceutical form of applied drug IV Liquid injection
specifications
Proposed Pack size 10ml;1’s
Approved by MHRA of UK
authorities
For generic drugs (me-too status) Ferotox 50mg/ml Injection of M/s Wilshire Laboratories
Reg.# 108356
GMP status of the Finished product GMP certificate issued on the basis of inspection
manufacturer conducted on 17& 18-01-2019
Evidence of manufacturing facility. GMP certificate issued on the basis of inspection
conducted on 17& 18-01-2019, declares availability of
Liquid injectable vial & ampoule section.
Name and address of API manufacturer. M/s Nanjing Hancer Pharmaceutical Co., Ltd., China,
No. 18 Hichang Road, Lishui Economi Technlogical
Development one Jiangsu, China.

controls, specifications, analytical procedures and its
specification, container closure system and stability
studies of drug substance
description of manufacturing process and controls, ,
specifications, analytical procedure and its verification
studies, batch analysis and justification of specification,
comparative dissolution profile against the Ferinject Injection.
Analytical method --
Manufacturer of API M/s Nanjing Hancer Pharmaceutical Co., Ltd., China, No. 18 Hichang Road,
Lishui Economi Technlogical Development one Jiangsu, China.
API Lot No. R210302
Description of Pack
(Container closure Type I glass vial.
system)
Frequency Accelerated: 0,3,6 (Months)
Real Time: 0,3,6 (Months)
Batch No. FRI-001 FRI-002 FRI-003
Batch Size 5000 packs 10,000 packs 10,000 packs
No. of Batches 03
the firm (if any)

2. Approval of API/ DML/GMP certificate Copy of GMP certificate No.JS20180811 issued by
of API manufacturer issued by NMPA China valid till 06-05-2023.
country of origin.
3. Documents for the procurement of API • Firm has submitted copy of commercial invoice no.
with approval from DRAP (in case of HC2IT09T001-01 attested by AD DRAP I&E Lahore
import). dated 02-07-2021 for the import of 50Kg Ferric
Carboxymaltose..
sheets etc.
testing
accelerated)

3.2.S.4.2 • Drug substance analytical • Firm has submitted analytical procedure
procedure applied by drug from drug substance manufacturer.
substance manufacturer shall be • Revised analytical procedure has been
submitted. submitted wherein limit for Assay test
• Limits for the Content of Iron has been declared in term of 5age of iron.
declared in the analytical
procedure for Assay is not as per
those submitted in drug substance
specifications.
3.2.S.4.3 Analytical method verification studies Submitted.
for the Assay test procedure of drug
substance shall be submitted form M/s
English Pharmaceuticals.
3.2.P.3.5 Submitted process validation protocol Firm has submitted revised process
does not identifies Mixing stage as validation protocol including mixing stage
critical process parameter. as critical process parameter.
3.2.P.5.3 Analytical method validation studies Firm has submitted analytical method
for the Assay test of Iron content shall validation studies for the titration method of
be submitted. Assay for drug product.
3.2.P.8 • Digital data logger record for Submitted.
accelerated stability chamber shall Firm has justified dispensed quantity of
be submitted. ferric carboxymaltose considering the
• Dispensed quantity of Ferric %age Assay results calculated on “as is
carboxymaltose, during batch basis.”
manufacturing shall be justified
against the label claim of Iron.
Decision of 320th meeting: Approved with Innovator’s specifications and change of brand name.

92. Name, address of Applicant / M/s Daneen Pharma Private Limited 27-Sundar
Marketing Authorization Holder Industrial Estate, Sundar Raiwind Road, Lahore
Name, address of Manufacturing site. M/s Genix Pharma Private Limited 44-45B Korangi
creek road Karachi
☐ Importer
Status of application  New Drug Product (NDP)
🗵 Generic Drug Product (GDP)
☐ Export sale
Danforge-A Tablets 10mg/160mg
name
Active Pharmaceutical ingredient (API) Amlodipine eq. to Amlodipine Besylate…..10mg
per unit Valsartan…………………..160mg
Pharmaceutical form of applied drug Round, Biconvex, Light Orange color, film coated
tablet, engraved “GENIX” on one side & break line on
other side.
Pharmacotherapeutic Group of (API) Antihypertensive
U.S.P Specification
specifications
Proposed Pack size 7’s, 14’s & 28’s
Exforge tablet by M/s Novartis USFDA Approved.
authorities
For generic drugs (me-too status) Covam Tablets by M/s Getz Pharma
GMP status of the Finished product New GMP granted on 07/10/2021
manufacturer Tablet section (General & Psycotropic) approved.
Name and address of API manufacturer. Amlodipine: Amsal Chem Private Limited, A-
1/401/2/3, GIDC Industrial Estate Ankleshwar - 393
002, District Bharuch, Gujarat, India Valsartan:
Zhejiang Tianyu Pharmaceutical Co., Ltd. No.15,
Donghai 5th Avenue, Zhejiang Provincial Chemical
and Medical Raw Materials Base Linhai Zone, Taizhou
City, Zhejiang Province, China. P.C.:317016

Amlodipine:
Batches: (13002/APL,13003/APL& 13004/APL)
Valsartan:
Batches: (201207301, 201207302& 201207303)
comparative dissolution profile against the relevant strength of Covam Tablet by M/s
Getz Pharma by performing quality tests
(Identification, Assay, Dissolution)
Covam Tablet by Getz Pharma in Acid media (0.1N
HCl), Acetate buffer of pH 4.5 & Phosphate Buffer (pH
6.8). The f2 value was in acceptable range.
of product including justification of system suitability, specificity,
linearity, accuracy, precision-repeatability.
Amlodipine: Amsal Chem Private Limited, A-1/401/2/3, GIDC Industrial
Estate Ankleshwar - 393 002, District Bharuch, Gujarat, India
Manufacturer of API Valsartan: Zhejiang Tianyu Pharmaceutical Co., Ltd. No.15, Donghai 5th
Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base
Linhai Zone, Taizhou City, Zhejiang Province, China
API Lot No. Amlodipine: 17019/AB, Valsartan: 10200-171201
Description of Pack
(Container closure Alu/alu blister
system)
Time Period

Accelerated:0,3 & 6(Months)
Frequency
Real Time: 0,3, 6, 9 ,12,18 & 24 (Months)
Batch No. 001T199 002T199 003T199
Batch Size 100,000 Tablets 100,000 Tablets 100,000 Tablets
No. of Batches 03
Reference of previous approval of
1. applications with stability study data of N/A
the firm (if any)
Amlodipine: Copy of GMP certificate No. 1991611
Approval of API/ DML/GMP certificate issued by Food & Drugs control administration,
2. of API manufacturer issued by concerned Gujarat, India valid till 23/09/2022
regulatory authority of country of origin. Valsartan: Copy of GMP certificate No. ZJ20180033
issued by CFDA valid till 14/03/2023
Amlodipine: Copy of Purchase invoice
No.AE/2122/0090 attested by AD DRAP I&E dated
Documents for the procurement of API
30/07/2021is submitted
3. with approval from DRAP (in case of
Valsartan: Copy of Purchase invoice No.TY121560
import).
attested by AD DRAP I&E dated 09/07/2021 is
submitted
Data of stability batches will be supported
4. chromatograms, Submitted
sheets etc.
Compliance Record of HPLC software
5. 21CFR & audit trail reports on product N/A
testing
Record of Digital data logger for
6. Submitted
accelerated)
Name, address of Manufacturing site. M/s Genix Pharma Private Limited 44-45B Korangi
creek road Karachi
☐ Importer
☐ Export sale

name
Active Pharmaceutical ingredient (API) Amlodipine eq. to Amlodipine Besylate ……. 5mg
per unit Valsartan …………………. 160mg
other side.
U.S.P Specification
specifications
authorities
For generic drugs (me-too status) Covam Tablets by M/s Getz Pharma
Amlodipine:
Valsartan:

Batches: (201207301, 201207302& 201207303)
Description of Pack
system)
Time Period
Frequency
Real Time: 0,3, 6, 9 ,12,18 & 24 (Months)
Batch No. 001T198 002T198 003T198
No. of Batches 03
the firm (if any)

import).
submitted
sheets etc.
testing
6. Submitted
accelerated)
Name, address of Manufacturing site. M/s Genix Pharma Private Limited
44-45B Korangi creek road Karachi
☐ Importer
☐ Export sale
name
Active Pharmaceutical ingredient (API) Amlodipine eq. to Amlodipine Besylate…..5mg
per unit Valsartan…………………..80mg
other side.
U.S.P Specification
specifications
authorities
For generic drugs (me-too status) Covam 5mg/80mg Tablets by M/s Getz Pharma

Amlodipine:
Valsartan:
Batches: (201207301, 201207302& 201207303)

Description of Pack
system)
Time Period
Frequency
Real Time: 0,3, 6, 9 ,12,18 & 24 (Months)
Batch No. 001T197 002T197 003T197
No. of Batches 03
the firm (if any)
import).
submitted
sheets etc.
testing
6. Submitted
accelerated)

1.6.5 Name of manufacturing site of M/s The mentioned address in section
Amsal Chem, mentioned in section 1.6.5 & 3.2.S.1 is of administrative
1.6.5 & 3.2.S.2.1 is different form office. Howver, name of
that declared on GMP certificate. manufacturer is same as mentioned
on GMP certificate i.e., M/s Amsal
Che, Pvt. Ltd, Mumbai, India, A-
1,401,402,403 G.I.D.C industrial
Estate, Ankleshwar-393002,
District, Bharuch, Gujarat, India.
3.2.S.4.3 Analytical Method Verification Submitted.
precision) performed by the Drug
Product manufacturer shall be
submitted.
3.2.S.4.4 Provide results of analysis of Submitted.
relevant batch(es) of Drug
Substance performed by Drug
Product manufacturer used during
product development and stability
studies, along with Certificate of
Analysis (CoA) of the same batch
from Drug Substance manufacture.
3.2.S.5 Submit COAs of working standard Firm has submitted COA of working
used for the batch release for drug standard of both drug substances
substance used in the formulation of from relevant manufacturer.
stability batches of drug product.
3.2.P.2.2.1 Justification shall be submitted for Firm has submitted that due to
not performing Comparative unavailability of innovator sample in
dissolution & Pharmaceutical Pakistan, CDP was conducted
equivalence studies against the against Covam tablets of M/s Getz
innovator product. Pharma.
3.2.P.8.3 Submitted commercial invoices for Firm has now submitted following:
the import of drug substances are of • Amlodipine: Copy of Purchase
subsequent dates from the date of Invoice No. AE/227/17-18
manufacturing of stability batches. attested by AD DRAP I&E dated
21/12/2017 for batch# 17019/AB
• Valsartan: Copy of Purchase
invoice No. TYI18026 attested
by AD DRAP I&E dated
30/01/2018.
• Comparative dissolution & Pharmaceutical equivalence studies have been performed on the
recent batches manufactured by M/s Genix, instead of the stability batches.
Decision of 320th meeting: Registration Board approved Danforge-A Tablets 10mg/160mg,

Danforge-A Tablets 5mg/160mg & Danforge-A Tablets 5mg/80mg.

• Registration Board further decided that registration letter will be issued upon submission of
Pharmaceutical equivalence & CDP studies for each strength against the innovator drug
product.
95. Name, address of Applicant / Asian Continental (Pvt) Ltd., D/32 SITE Super
Marketing Authorization Holder Highway Karachi.
Name, address of Manufacturing site. M/s Wimits Pharmaceuticals (Pvt.) Ltd. Plot No. 129,
Sundar Industrial Estate, Raiwind Road, Lahore
☐ Importer
☐ Export sale
Vintera 30mg/ml Injection
name
Active Pharmaceutical ingredient (API) Ketorolac Tromethamine …… 30mg
per unit
Pharmaceutical form of applied drug Injectable solution
Pharmacotherapeutic Group of (API) Anti-inflammatory agent, non-steroid
USP
specifications
Proposed Pack size 1ml×5’s
The status in reference regulatory Ketorolac Tromethamine injection 30mg/ml by M/s
authorities Peckforton Pharmaceuticals Limited Crewe Hall,
Crewe, Cheshire, CW1 6UL, United Kingdom, MHRA
Approved.
For generic drugs (me-too status) Toradol Injection 30mg/ml by M/s Barrett Hodgson
Pakistan (Pvt.) Ltd.
Reg. No. 015000
manufacturer conducted on 08-11-2019.
Name and address of API manufacturer. M/s. Satyadivis Pharmaceuticals Pvt. Ltd., Survey No.
10, Gaddapotaram (V), Khazipally I.D.A., Jinnaram
(M), Sangareddy Dist.-502 319. T.S. INDIA

and controls, t, specifications, analytical procedures
product.
comparative dissolution profile against the Toradol 30mg/ml Injection of Barret
Hodgsosn
Manufacturer of API M/s. Satyadivis Pharmaceuticals Pvt. Ltd., Survey No. 10,
Gaddapotaram (V), Khazipally I.D.A., Jinnaram (M), Sangareddy Dist.-
502 319. T.S. INDIA
API Lot No. 0070320
Description of Pack
Glass ampoules
Batch No. KL021 KL022 KL023
Batch Size 100,000 100,000 ampoules 100,000 ampoules
ampoules
No. of Batches 03

Reference of previous approval N/A
1. of applications with stability
study data of the firm
Approval of API/ DML/GMP --
certificate of API manufacturer
2.
issued by concerned regulatory
Documents for the procurement The firm has submitted copy of commercial invoice# E023/KET
3. of API with approval from for import of 10Kg of Ketorolac tromethamine, attested by AD
DRAP (in case of import). DRAP I&E Lahore dated 20-07-2020.
Data of stability batches will be Submitted

4. documents like chromatograms,
data sheets etc.
Compliance Record of HPLC Submitted
5. software 21CFR & audit trail
reports on product testing
6. Record of Digital data logger for N/A
Sr.# Observations Firm’s response
Firm has submitted GMP certificate no.
Valid GMP certificate of the
75331/TS/2022 issued by Drug Control
1.6.5 drug substance manufacturer
Administration Government of
shall be submitted.
Telangana valid until 21/01/2023.
Microbial report for the sterility Firm has submitted Sterility
3.2.S.4.4 testing of drug substance by M/s test/Bacterial Endotoxin test report for
Wimits shall be submitted. the drug substance Batch# 0070320.
Justification shall be submitted Firm has submitted Pharmaceutical
for not performing Equivalence studies against Toradol
3.2.P.2.2.1 Pharmaceutical equivalence injection of M/s Barret Hodgson.
studies against the innovator
product.
Firm has referred to USP General
Justification shall be submitted
Chapter <1151> wherein excess
3.2.P.5.1 for additional fill volume in
volume of 0.1ml is allowed for 1ml
each ampoule.
injection.
Concentrations in term of Firm has submitted concentration in
mg/ml shall be provided for terms of mg/ml for each concentration
3.2.P.5.3 three concentration levels level of Accuracy parameter
tested in performance of performance.
Accuracy parameter
COA of working standard used Firm has submitted COA of working
for the analysis of drug product standard “Ketorolac tromethamine
3.2.P.6
stability batches shall be USP” valid upto Feb-2023.
submitted.

96. Name, address of Applicant / M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
Marketing Authorization Holder Industrial Estate, Lahore
Name, address of Manufacturing site. M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
☐ Importer
Elmet XR 25/25/1000 mg Tablet
brand name
Strength / concentration of drug of Each film-coated extended-release tablet contains:
Active Pharmaceutical ingredient Empagliflozin ……………….. 25mg
(API) per unit Linagliptin …………………… 25 mg
(as immediate release coating)
Metformin HCl …………… 1000mg
(as extended release core)
Pharmaceutical form of applied drug Film-coated extended-release tablet
Pharmacotherapeutic Group of (API) Empagliflozin: sodium-glucose co-transporter 2
(SGLT2) inhibitors
Linagliptin: dipeptidyl peptidase-4 (DPP-4) inhibitors
Metformin HCl: antihyperglycemic drug
Innovator
specifications
The status in reference regulatory Trijardy® XR Tablets by M/s Boehringer Ingelheim, FDA
For generic drugs (me-too status) Not Available
Evidence of manufacturing facility GMP certificate granted on basis of inspection conducted
on 18.06.2020 endorses tablet general section.
GMP status of the Finished product GMP certificate granted on basis of inspection conducted
manufacturer on 18.06.2020.

Name and address of API Linagliptin:
manufacturer. M/s Lee Pharma Limited, India
HuaiNan ShunLong Pharmaceutical CO, LTD. No. 9
Yongxing Road, Econonmic and Technological
Development Development Zone, Huainan City, Anhui
Province China.
Empagliflozin:
Province China.
Metformin Hydrochloride:
Shandong Keyuan Pharmaceutical Co., Ltd. Keyuan
Street, Shandong shanghe Economic Zone, Jinan city,
Shandong Province, China
submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data on CTD
format related to nomenclature, structure, general
impurities, specifications and analytical procedures, batch
drug substance.
Stability studies of Drug substance Empagliflozin:
Linagliptin:
Metformin HCl:
Module-III (Drug Product): Firm has submitted data of drug product including its
manufacturing process and process control, control of
analytical procedures, validation of analytical procedures,
batch analysis, justification of specifications, reference
stability.

Pharmaceutical equivalence and Pharmaceutical Equivalence have been established against
comparative dissolution profile the brand leader that is Trijardy XR Tablets 25/25/1000mg
approved by US-FDA. CDP has been performed against
the same brand that is Trijardy XR Tablets
12.5/2.5/1000mg approved by US-FDA in Acid media (pH
1.2) , Acetate Buffer (pH 4.5) & Phosphate Buffer (pH 6.8)
validation/verification of product Specificity, linearity, range, accuracy, precision
Repeatability, Intermediate precision, Robustness, System
Suitability.
Manufacturer of API Linagliptin:
M/s Lee Pharma Limited, India
Sy No. 10/G-1, Gadda Potharam (VillageJinnaram (Mandal), Medak
(District) Telangana, 502319, INDIA.
Empagliflozin:
Jiangsu Yongan Pharmaceuticals Co., Limited.
No.18, 237 Provincial Road, Economic Development Zone, Huaian, Jiangsu,
China.
IOL Chemicals and Pharmaceuticals Limited 85 Industrial Area ‘A’ Ludhiana-
141003 Punjab. India.
API Lot No. Empagliflozin: 20200705
Linagliptin: 20200701
Metformin HCl: P5102004020
Description of Pack
(Container closure Alu-Alu. Blisters with aluminum foil having leaflet and packed in unit carton
system)
Time Period
Frequency
Batch No. MLEH-001 MLEH-002 --
Batch Size 5000 tab 5000 tab --
Manufacturing Date 02-2021 02-2021 --
Date of Initiation 02-2021 02-2021 --
No. of Batches 02
Name, address of Manufacturing site. M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
☐ Importer

Elmet XR 10/5/1000 mg Tablet
brand name
Active Pharmaceutical ingredient Empagliflozin ……………….. 10mg
(API) per unit Linagliptin …………………… 5 mg
Pharmaceutical form of applied drug Film-coated extended-release tablet
Pharmacotherapeutic Group of (API) Empagliflozin: sodium-glucose co-transporter 2
(SGLT2) inhibitors
Linagliptin: dipeptidyl peptidase-4 (DPP-4) inhibitors
Metformin HCl: antihyperglycemic drug
Innovator
specifications
The status in reference regulatory Trijardy® XR Tablets by M/s Boehringer Ingelheim, FDA
Evidence of manufacturing facility GMP certificate granted on basis of inspection conducted
on 18.06.2020 endorses tablet general section.
GMP status of the Finished product GMP certificate granted on basis of inspection conducted
manufacturer on 18.06.2020.
Province China.
Empagliflozin: HuaiNan ShunLong Pharmaceutical CO,
LTD. No. 9 Yongxing Road, Econonmic and
Technological Development Development Zone,
Huainan City, Anhui Province China.
Metformin Hydrochloride: Shandong Keyuan
Pharmaceutical Co., Ltd. Keyuan Street, Shandong
shanghe Economic Zone, Jinan city, Shandong Province,
China

submitted.
format related to nomenclature, structure, general
impurities, specifications and analytical procedures, batch
drug substance.
Linagliptin:
Metformin HCl:
analytical procedures, validation of analytical procedures,
batch analysis, justification of specifications, reference
stability.
comparative dissolution profile the brand leader that is Trijardy XR Tablets 10/5/1000mg
approved by US-FDA. CDP has been performed against
the same brand that is Trijardy XR Tablets
12.5/2.5/1000mg approved by US-FDA in Acid media (pH
1.2) , Acetate Buffer (pH 4.5) & Phosphate Buffer (pH 6.8)
Suitability.
Sy No. 10/G-1, Gadda Potharam (VillageJinnaram (Mandal), Medak
(District) Telangana, 502319, INDIA.
Empagliflozin:

China.
Description of Pack
system)
Time Period
Frequency
Batch No. MLEL-001 MLEL-002 --
No. of Batches 02
Name, address of Manufacturing M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33, Sundar
site. Industrial Estate, Lahore
☐ Importer
Elmet XR 12.5/2.5/1000 mg Tablet
brand name
Active Pharmaceutical ingredient Empagliflozin ……………….. 12.5mg
(API) per unit Linagliptin …………………… 2.5 mg
Film-coated extended-release tablet
drug

Pharmacotherapeutic Group of
Antidiabetic
(API)
Innovator
specifications
The status in reference regulatory Trijardy® XR Tablets 12.5mg/2.5mg/1000mg by M/s
authorities Boehringer Ingelheim, FDA Approved.
Evidence of manufacturing facility GMP certificate granted on basis of inspection conducted on
18.06.2020 endorses tablet general section.
GMP status of the Finished product GMP certificate granted on basis of inspection conducted on
manufacturer 18.06.2020.
Province China.
Empagliflozin:
Province China.
Shandong Keyuan Pharmaceutical Co., Ltd. Keyuan Street,
Shandong shanghe Economic Zone, Jinan city, Shandong
Province, China
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS-PD template.
Summary) Summarized information related to nomenclature, structure,
controls, impurities, specifications, analytical procedures and
submitted.
format related to nomenclature, structure, general properties,
specifications and analytical procedures, batch analysis and
justification of specification, reference standard, container
closure system and stability studies of drug substance.
Linagliptin:
Metformin HCl:

excipients, control of drug product, specifications, analytical
procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference standard or
comparative dissolution profile the brand leader that is Trijardy XR Tablets 12.5/2.5/1000mg
approved by US-FDA. CDP has been performed against the
same brand that is Trijardy XR Tablets 12.5/2.5/1000mg
approved by US-FDA in Acid media (pH 1.2) , Acetate
Buffer (pH 4.5) & Phosphate Buffer (pH 6.8)
Suitability.
Sy No. 10/G-1, Gadda Potharam (VillageJinnaram (Mandal), Medak (District)
Telangana, 502319, INDIA.
Empagliflozin:
China.
Description of Pack
system)
Time Period
Frequency
Batch No. MLEM-001 MLEM-002 --
No. of Batches 02
Documents submitted along with stability data

1. Reference of previous approval of Firm has referred to onsite inspection report of their product:
data of the firm (if any) EMPAZON 10mg Tablets, EMPAZON 25mg Tablets
(Empagliflozin) & Dayzol 30mg Capsules, Dayzol 60mg
Capsules (Dexlansoprazole) which was conducted on 1st
June, 2021 and was presented in 307th meeting of
Registration Board held on 08-10th June , 2021.
Registration Board decided to approve registration of
EMPAZON 10mg Tablets, EMPAZON 25mg Tablets

(Empagliflozin) &Dayzol 30mg Capsules, Dayzol 60mg
Capsules (Dexlansoprazole) by M/s. Horizon Healthcare
(Pvt) Ltd. Lahore. Manufacturer will place first three
production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Following two observations were reported in the report:

i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of EMPAZON 10mg
and 25mg Tablets, Dayzol 30mg and 60mg Capsules is
available.
iii. Adequate monitoring and control are available for
stability chamber. Chamber are controlled and
alerts as well.
2. Approval of API/ DML/GMP • Firm had provided valid GMP (No. AH20180451) &
certificate of API manufacturer DML (No. 20160342) Certificate of M/s HuaiNan
issued by concerned regulatory ShunLong Pharmaceutical CO, LTD.
authority of country of origin. Issued by China Food & Drug Administration
DML Valid upto: 31-12-2025
GMP Valid upto: 07-04-2023
• Firm had provided valid GMP(No. SD 20170595) &
DML (No. LU202000453) Certificate of M/s Shandong
Keyuan Pharmaceutical Co., Ltd.
Issued by China Food & Drug Administration
GMP Valid upto: 14-08-2022
3. Documents for the procurement of Copy of commercial invoice attested by AD I&E DRAP,
API with approval from DRAP (in Lahore, has been submitted.
case of import). Empagliflozin:
Batch Invoice No. Quantity Date of
No. Imported approval
by
DRAP
20200705 JF20201013 0.700kgs 07-12-
2020
5 Linagliptin:
Batch Invoice No. Quantity Date of
No. Imported approval
by
DRAP

20200701 JF20201014 0.2 00kgs 07-12-
2020
Metformin HCl:
Batch No. Invoice No. Quantity Date of
Imported approval
by
DRAP
P5102004020 SDKY2020084403 100kgs 27-08-
2020

data sheets etc.
5. Compliance Record of HPLC Audit trail reports have been submitted.
on product testing.
6. Record of Digital data logger for Digital data logger record has been submitted for temperature
temperature and humidity & humidity conditions of both accelerated and long-term
monitoring of stability chambers stability chambers.
(real time and accelerated).

3.2.S.4 Copies of the Drug substance Firm has submitted drug
specifications used for routine testing of substance specifications adopted
the Drug substance by Drug Product by M/s Horizon.
3.2.P.5.3 Specificity studies shall be submitted for Firm has submitted UV spectra
the Analysis method of Metformin in for the performance of
Dissolution test, wherein it could be Specificity parameter for
established that the UV absorbance dissolution test revealing that
results for Metformin HCl are not absorbance of Linagliptin and
interfered with the presence of other two empagliflozin has not been
Drug substances in the sample aliquot. interfered
3.2.P.6 • Submitted COA of working Firm has submitted COA of
standard of Metformin HCl declares working standards of Metformin
retest date as May 2021, whereas HCl & Empagliflozin with retest
stability studies have also been date as of May 2023 & March
performed subsequent to this date. 2023 respectively.
• Submitted COA of working
standard of Empagliflozin declares
retest date as March 2021, whereas
stability studies have also been
performed subsequent to this date.
• Submit details of excess Active coating solution Firm has submitted that we use
used to achieve desired content of Empagliflozin excess active coating solution
& Linagliptin. due to process loss process loss
details of which have been
submitted.

Decision of 320th meeting: Registration Board approved Elmet XR 25/25/1000 mg Tablet, Elmet
XR 10/5/1000 mg Tablet & Elmet XR 12.5/2.5/1000 mg Tablet with Innovator’s specifications.
Deferred cases
99. Name, address of Applicant / M/s Usawa Pharmaceuticals. 146 S.I.Z.

Marketing Authorization Holder Risalpur, KPK, Pakistan
Name, address of Manufacturing site. M/s Bio Labs Pvt Ltd. Plot # 145, Industrial
Triangle, Kahuta Road, Islamabad
☐ Importer
☐ Export sale
facility dated 23-07-2012 which specifiesLyophilized vials
(General) for M/s Bio-Labs Pharma
UswaTig 50mg Injection
name
Active Pharmaceutical ingredient (API) Tigecycline (Lyophilized powder)………50mg
per unit
Pharmaceutical form of applied drug Lyophilized Powder for Injection
Pharmacotherapeutic Group of (API) Antibacterial agent
USP
specifications
Approved by US FDA
authorities
For generic drugs (me-too status) Tigewel Injection of M/s Welwrd Pharma (Reg.#
082530)
GMP status of the Finished product GMP certificate issued on 13-08-2020.
manufacturer

Name and address of API manufacturer. Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co. Ltd .No .1 human Yi Road,
Changshou District, Chongqing 401254,P.R China.
template.
Characterization, specifications, analytical
drug substance. The firm has summarized
information of drug product including its
validation/verification of analytical procedures,
Real time: 6oC ± 2 oC, RH for 36 months
Accelerated: 25oC ± 2oC/60% ± 5%RH for 6
months
Batches: (Til00701V, Til00702V, Til00703V)
comparative dissolution profile equivalence for all the quality tests for their product
against the comparator i.e. BTig 50mg injection by
Bosch pharmaceuticals.
Analytical method validation/verification Method verification studies have been submitted.
of product

Manufacturer of API Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co. Ltd. No .1 human Yi Road,
Changshou District, Chongqing 401254, P.R China.
API Lot No. Ti191201
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
Batch Size 1000 Vials 1000 Vials 700 vials
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate (No.
of API manufacturer issued by CQ20180031) issued by Chongqing food and drug
concerned regulatory authority of administration valid upto 09-10-2023.
country of origin.
3. Documents for the procurement of API • Firm has submitted copy of Licenses to Import
with approval from DRAP (in case of Drug substance Tigecycline issued by AD I&E
import). DRAP, Islamabad dated 05-08-2019 & 02-04-
2020.
4 Data of stability batches will be Submitted
etc.
5. Compliance Record of HPLC software NA
testing
temperature and humidity monitoring of temperature and humidity monitoring of real time
stability chambers (real time and and accelerated stability chambers.
accelerated).
• 3.2. S.4 limits for test of pH submitted in the drug • Firm has submitted revised
Acceptance
substance specifications is not as per the USP documents submitted without
monograph for “Tigecycline”. justifying the deviations observed
• The details of coloumn temperature, mobile phase in previously submitted data.
preparation, system suitability solution mentioned in the • Temperature for autosampler not
reflected in analytical method.

Assay test method by Drug substance manufacturer is • Firm has submitted Bioburden test
not as per the USP monograph for “Tigecycline”. report from M/s Bio Lab for another
• Submitted COA from M/s Bio-labs reflect that tests of batch than that submitted earlier.
Bacterial Endotoxin & sterility have not been • Drug substance specifications and
performed. analytical procedure has been
• Copies of the Drug substance specifications and submitted from M/s Bio-Labs, but
analytical procedures used for routine testing of the these documents are not formal and
Drug substance /Active Drug Product manufacturer is does not bear any document no.,
required. issue date or effective date.
• Analytical Method Verification studies including • Analytical method verification
specificity, accuracy and repeatability (method studies have been submitted from
precision) performed by the Drug Product manufacturer M/s Bio-Labs.
shall be submitted. • COA from API manufacturer has
• Provide results of analysis of relevant batch(es) of Drug been submitted, which declares the
Substance performed by Drug Product manufacturer product name as “Tigecycline
used during product development and stability studies, lyophilized”, whereas COA of M/s
along with Certificate of Analysis (CoA) of the same Bio-Lab declares it as
batch from Drug Substance / /Active Pharmaceutical “Tigecycline” only.
Ingredient manufacture. • No Evidence of availability of Auto
• Evidence of availability of Auto sampler in HPLC, sampler in HPLC, wherein 10oC
wherein 10oC temperature conditions could be temperature conditions could be
maintained. maintained.
• COA 3.2.of
S.5 primary / secondary reference standard COA of working standard has been
including source and lot number shall be provided. submitted from M/s Fuan
Pharmaceutical, China.
3.2. S.7 • The USP monograph for Firm has submitted stability studies
“Tigecycline” recommends storage data of drug substance for the same
condition as at refrigerated batches as submitted earlier, wherein
temperature, whereas stability only conditions of storage have been
studies data has been submitted as per changed as reuired for a refrigerated
room temperature conditions. item, while the analytical values for all
• Specifications for pH & specific the tests are same as presented earlier.
optical rotation applied in stability
studies is different from that
submitted in section 3.2.S.4.4.
3.2.P.1 • Inclusion of lactose monohydrate in MHRA approved reference given.
the composition shall be justified
since innovator product approved by
US FDA & EMA is formulated
without use of any excipient.
3.2.P.2.1 • Compatibility studies of the Drug MHRA approved reference given.
Substance(s) with Lactose shall be
provided since innovator product
approved by US FDA & EMA is
formulated without use of any
excipient.
• 3.2. P.5 of fill weight/vial shall be• submitted.
Specifications Following not given
• Specifications does not include test •of Specifications
“Particulate of fill weight/vial shall be submitted.
matter”. • Evidence of availability of Auto sampler in HPLC,
• Evidence of availability of Auto samplerwhereinin HPLC, 10oC temperature conditions could be
o
wherein 10 C temperature conditions maintained.could be
maintained. • Peak integration is not proper, since it does not
coincide with the base line.

• Precision parameter has not been performed • Documents in theare not formal and does not bear any
analytical method verification studies. document no., issue date or effective date.
• • Submitted
COAs of relevant batches for which stability studies dataCOAs does no tinclude test of particulate
has been submitted, shall be provided. matter as recommended by the USP monograph of
“Tiogecycline for injection”
• Submitted working standard COA reflect date of COA of working standard submitted
3.2.P.6
analysis as 14-12-2019, whereas stability batches have with date of analysis as 25-12-2017,
been analysed prior to this date. wherein the reference standard (lot#
F0M325) used for its standardization
was valid upto 30-09-2017.
• Firm3.2. P.8submitted copy of Licenses •to Import
has InvoicesDrug
shared are still subsequent to the date of
substance Tigecycline issued by AD I&E manufacturing
DRAP, of two batches. i.e. L-131 & L-138
Islamabad dated 05-08-2019 & 02-04-2020, with whereas
manufacturing date of 03-2018, whereas
stability batches have been manufactured prior submitted
to these
invoice is of 08-2019.
dates. • Submitted invoice is for “Tigecycline lyophilized”.
• Clarification shall be submitted whether • Firm submitted
has submitted that provided data is of
stability studies data is of trial batches orcommercial
commercialbatches.
batches. • Raw data sheets submitted.
• Raw data sheets for stability studies,• reflecting the
Revised stability study sheets have been submitted.
details of Standard weight, Sample dilution preparation,
Potency of Reference standard and Calculation formula
applied for the Assay test shall be submitted.
• As per submitted stability studies data, test of particulate
matter has not been performed, justification shall be
• Dates of testing written in the stability summary sheets
for different time points, does not relate with the relevant
duration in months.
• As per submitted BMRs potency • BMR was written with standard
adjustment has not been done for the batch formula and now it been
Drug substance, based upon the revised with potency adjustment as
actual Assay results. per potency of drug substance.
• As per submitted BMRs, lactose • Revised BMR mentions the
monohydrate has been used in the dispensed quantity of API on the
formulation, whereas innovator basis of 99% potency, whereas
product has been formulated without asper submitted COA of drug
use of any excipient. Justification substance from M/s Bio-Labs, the
shall be submitted in this regard. potency of API is 98.4% on as is
• Details of the minimum handling basis.
capacity of the compounding vessel • Submitted BMRs does not reflect
used for manufacturing of stability any test of filled weight per vial,
batches shall be submitted shall be sterility testing at any stage.
submitted. • Details of the minimum handling
• Submitted BMRs have not been filled capacity of the compounding vessel
completely. used for manufacturing of stability
batches have not been submitted.
• Submission of formal documents for drug substance specifications & analytical procedures form M/s
Bio-Labs, wherein details of document no., issue date or effective date shall have been mentioned.
• Evidence of availability of Auto sampler in HPLC, wherein 10oC temperature conditions could be
maintained.
• Firm has submitted stability studies data of drug substance for the same batches as submitted earlier,
wherein only conditions of storage have been changed as required for a refrigerated item, while the
analytical values for all the tests are same as presented earlier.

• Specifications of fill weight/vial shall be submitted.
• Peak integration is not proper, since it does not coincide with the base line.
• Submitted commercial invoices for the procurement of drug substance are still subsequent to the date
of manufacturing of two batches. i.e. L-131 & L-138 with manufacturing date of 03-2018, whereas
submitted invoice is of 08-2019.
• Scientific justification shall be submitted for use of Lyophilized powder of drug substance for the
manufacture of finished drug product by way of lyophilization.
• Revised BMR mentions the dispensed quantity of API on the basis of 99% potency, whereas as per
submitted COA of drug substance from M/s Bio-Labs, the potency of API is 98.4% on as is basis.
• Submitted BMRs does not reflect any test of filled weight per vial, sterility testing at any stage.
• Details of the minimum handling capacity of the compounding vessel used for manufacturing of
stability batches have not been submitted.
• Submitted COAs of drug product does not include test of particulate matter as recommended by the
USP monograph of “Tigecycline for injection”
Firm’s reply:
Observation Firm’s Reply
• Submission of formal documents for Firm has submitted analytical procedure,
drug substance specifications & wherein mobile phase composition is
analytical procedures form M/s Bio- different from that proposed by the drug
Labs, wherein details of document no., substance manufcaturer.
issue date or effective date shall have
been mentioned.
Evidence of availability of Auto sampler in Fimr has submitted specification sof of
HPLC, wherein 10oC temperature auto sampler assembled with HPLC of
conditions could be maintained. Perkin Almer 200LC, wherein operating
conditions for “Ambient temperature” are
mentioned as 10- 30oC.
Firm has submitted stability studies data of The stability data has been done as per
drug substance for the same batches as recommended storage conditions. There
submitted earlier, wherein only conditions was typographic error in the data.
of storage have been changed as required
for a refrigerated item, while the analytical
values for all the tests are same as presented
earlier.
Specifications of fill weight/vial shall be The product is in lyophilized form. For this
submitted. 2 ml solution per vial was filled and then
lyophilized.
It is pertinent to mention that vials are
filled with 2 ml solution at an intermediate
stage, whereas final dosage form of the
applied product is in the powder form
hence fill weight specifications are
necessary to establish uniformity of
dosage.
Peak integration is not proper, since it does Firm has submitted chromatograms again
not coincide with the base line. with justification that the attenuation is
increased which results in the proper
coinciding of baseline.
• Submitted commercial invoices for the No reply submitted.
procurement of drug substance are still
subsequent to the date of
manufacturing of two batches. i.e. L-
131 & L-138 with manufacturing date

of 03-2018, whereas submitted invoice
is of 08-2019.
• Scientific justification shall be The bulk and raw material of tigecycline is
submitted for use of Lyophilized also available in lyophilized/sterilized
powder of drug substance for the form. The raw material was then
manufacture of finished drug product formulated into solution form which is
by way of lyophilization. then filled and lyophilized.
• Revised BMR mentions the dispensed Firm has declared it as a typographic error,
quantity of API on the basis of 99% and has submitted revised COA of drug
potency, whereas as per submitted substance wherein Assay value has been
COA of drug substance from M/s Bio- declared as 99% on anhydrous basis,
Labs, the potency of API is 98.4% on which still does not justify the dispensed
as is basis. amount on basis of “as is potency”, since
water content has been declared as 1.3%.
Submitted BMRs does not reflect any test The solution is filled in the vials. The
of filled weight per vial, sterility testing at volume variation/checklist is attached.
any stage
• Details of the minimum handling The solution is filled in glass beaker (5Ltr)
capacity of the compounding vessel whose minimum handling capacity is
used for manufacturing of stability 500ml.
Submitted COAs of drug product does not Firm has submitted revised COAs of drug
include test of particulate matter as product for complete stability studies,
recommended by the USP monograph of wherein test of “Particular matter” has now
“Tigecycline for injection”. been included.
th
Decision of 320 meeting: Deferred for following:
• Submission of commercial invoices attested by AD DRAP I&E, for the procurement of drug
substance used to manufacture drug product batches. i.e. L-131 & L-138.
• Specifications for the fill weight/vial shall be submitted.
• Evidence of performance of sterility testing at the time of batch release shall be submitted.
• Scientific justification shall be submitted for using glass beaker (5Ltr) for the compounding
the commercial scale batches.
• Verification of the claim of the firm regarding submitted HPLC chromatograms that
“attenuation is increased which results in the proper coinciding of baseline.”
100. Name, address of Applicant / M/s Gray's Pharmaceuticals. Plot No. 2, street
Marketing Authorization Holder No.N-3, National Industrial Zone, Rawat
Islmabad.
☐ Importer
☐ Export sale

Bacticil 50mg Injection IV
name
Active Pharmaceutical ingredient (API) Tigecycline (Lyophilized powder) ……… 50mg
per unit
USP
specifications
Approved by US FDA
authorities
082530)
manufacturer
template.

Real time: 6oC ± 2 oC,RH for 36 months
months
of product
Changshou District, Chongqing 401254, P.R
China.
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
No. of Batches 03
applications with stability study data
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (No.
certificate of API manufacturer issued CQ20180031) issued by Chongqing food and drug
by concerned regulatory authority of administration valid upto 09-10-2023.
country of origin.

3. Documents for the procurement of • Firm has submitted copy of Licenses to Import
API with approval from DRAP (in Drug substance Tigecycline issued by AD I&E
case of import). DRAP, Islamabad dated 05-08-2019 & 02-04-
2020.
data sheets, COA, summary data
sheets etc.
5. Compliance Record of HPLC NA
on product testing
temperature and humidity monitoring temperature and humidity monitoring of real time
of stability chambers (real time and and accelerated stability chambers.
accelerated).
• 3.2. S.4 limits for test of pH submitted in the drug • Firm has submitted revised
Acceptance
substance specifications is not as per the USP documents submitted without
monograph for “Tigecycline”. justifying the deviations observed
• The details of coloumn temperature, mobile phase in previously submitted data.
preparation, system suitability solution mentioned in the • Temperature for autosampler not
Assay test method by Drug substance manufacturer is reflected in analytical method.
not as per the USP monograph for “Tigecycline”. • Firm has submitted Bioburden test
• Submitted COA from M/s Bio-labs reflect that tests of report from M/s Bio Lab for another
Bacterial Endotoxin & sterility have not been batch than that submitted earlier.
performed. • Drug substance specifications and
• Copies of the Drug substance specifications and analytical procedure has been
analytical procedures used for routine testing of the submitted from M/s Bio-Labs, but
Drug substance /Active Drug Product manufacturer is these documents are not formal and
required. does not bear any document no.,
• Analytical Method Verification studies including issue date or effective date.
specificity, accuracy and repeatability (method • Analytical method verification
precision) performed by the Drug Product manufacturer studies have been submitted from
shall be submitted. M/s Bio-Labs.
• Provide results of analysis of relevant batch(es) of Drug • COA from API manufacturer has
Substance performed by Drug Product manufacturer been submitted, which declares the
used during product development and stability studies, product name as “Tigecycline
along with Certificate of Analysis (CoA) of the same lyophilized”, whereas COA of M/s
batch from Drug Substance / /Active Pharmaceutical Bio-Lab declares it as
Ingredient manufacture. “Tigecycline” only.
• Evidence of availability of Auto sampler in HPLC, • No Evidence of availability of Auto
wherein 10oC temperature conditions could be sampler in HPLC, wherein 10oC
maintained. temperature conditions could be
maintained.
• COA 3.2.S.5
of primary / secondary reference standard COA of working standard has been
including source and lot number shall be provided. submitted from M/s Fuan
Pharmaceutical, China.
condition as at refrigerated batches as submitted earlier, wherein
only conditions of storage have been

temperature, whereas stability changed as required for a refrigerated
studies data has been submitted as per item, while the analytical values for all
room temperature conditions. the tests are same as presented earlier.
• Specifications for pH & specific
studies is different from that
submitted in section 3.2.S.4.4.
3.2.P.1 • Inclusion of lactose monohydrate in MHRA approved reference given.
the composition shall be justified
since innovator product approved by
US FDA & EMA is formulated
without use of any excipient.
formulated without use of any
excipient.
3.2. P.5 • Specifications of fill weight/vial • Following not given
shall be submitted. • Specifications of fill
• Specifications does not include weight/vial shall be submitted.
test of “Particulate matter”. • Evidence of availability of
• Evidence of availability of Auto Auto sampler in HPLC, wherein 10oC
sampler in HPLC, wherein 10oC temperature conditions could be
temperature conditions could be maintained.
maintained. • Peak integration is not proper,
• Precision parameter has not been since it does not coincide with the base
performed in the analytical method line.
verification studies. • Documents are not formal and
• COAs of relevant batches for does not bear any document no., issue
which stability studies data has been date or effective date.
submitted, shall be provided. • Submitted COAs does not
include test of particulate matter as
recommended by the USP monograph
of “Tiogecycline for injection”
3.2.P.6 • Submitted working standard COA of working standard submitted
COA reflect date of analysis as 14-12- with date of analysis as 25-12-2017,
2019, whereas stability batches have wherein the reference standard (lot#
been analysed prior to this date. F0M325) used for its standardization
3.2. P.8 • Firm has submitted copy of • Invoices shared are still
Licenses to Import Drug substance subsequent to the date of
Tigecycline issued by AD I&E DRAP, manufacturing of two batches. i.e. L-
Islamabad dated 05-08-2019 & 02-04- 131 & L-138 with manufacturing date
2020, whereas stability batches have of 03-2018, whereas submitted
been manufactured prior to these dates. invoice is of 08-2019.
• Clarification shall be submitted • Submitted invoice is for
whether submitted stability studies data “Tigecycline lyophilized”.
is of trial batches or commercial batches. • Firm has submitted that
• Raw data sheets for stability provided data is of commercial
studies, reflecting the details of Standard batches.
weight, Sample dilution preparation, • Raw data sheets submitted.
Potency of Reference standard and • Revised stability study sheets
have been submitted.

Calculation formula applied for the
Assay test shall be submitted.
• As per submitted stability studies
data, test of particulate matter has not
been performed, justification shall be
• Dates of testing written in the
stability summary sheets for different
time points, does not relate with the
relevant duration in months.
adjustment has not been done for the batch formula and now it has been
Drug substance, based upon the revised with potency adjustment as
actual Assay results. per potency of drug substance.
monohydrate has been used in the dispensed quantity of API on the
formulation, whereas innovator basis of 99% potency, whereas as
product has been formulated without per submitted COA of drug
use of any excipient. Justification substance from M/s Bio-Labs, the
shall be submitted in this regard. potency of API is 98.4% on as is
capacity of the compounding vessel • Submitted BMRs does not reflect
used for manufacturing of stability any test of filled weight per vial,
batches shall be submitted shall be sterility testing at any stage.
submitted. • Details of the minimum
• Submitted BMRs have not been filled handling capacity of the compounding
completely. vessel used for manufacturing of
stability batches have not been
submitted.
maintained.

Firm’s reply:
• Submission of formal documents for Firm has submitted analytical procedure;
Labs, wherein details of document no., substance manufacturer.
been mentioned.
Evidence of availability of Auto sampler in Fimr has submitted specification sof of
HPLC, wherein 10oC temperature auto sampler assembled with HPLC of
conditions could be maintained. Perkin Almer 200LC, wherein operating
earlier.
lyophilized.
dosage.
is of 08-2019.
manufacture of finished drug product formulated into solution from which is

any stage

• Scientific justification shall be submitted for using glass beaker (5Ltr) for the compounding
the commercial scale batches.
• Verification of the claim of the firm regarding submitted HPLC chromatograms that
“attenuation is increased which results in the proper coinciding of baseline.”
101. Name, address of Applicant / M/s Novartana Pharmaceuticals (Pvt). Ltd 87-B
Marketing Authorization Holder Plot of Sundar Industrial Area, Raiwind Road,
Lahore Pakistan.
☐ Importer
☐ Export sale
Novartig 50mg IV Injection
name
Active Pharmaceutical ingredient (API) Tigecycline (Lyophilized powder)………50mg
per unit

USP
specifications
Approved by US FDA
authorities
082530)
manufacturer
template.
Real time: 6oC ± 2 oC,RH for 36 months
months

of product
Changshou District, Chongqing 401254, P.R
China.
Description of Pack
Glass vial
Real Time: 0, 3, 6 ,9,12,18,24(Months)
Batch No. L-131 L-138 L-242
No. of Batches 03
certificate of API manufacturer issued CQ20180031) issued by Chongqing food and drug
by concerned regulatory authority of administration valid upto 09-10-2023.
country of origin.
3. Documents for the procurement of • Firm has submitted copy of Licenses to Import
API with approval from DRAP (in Drug substance Tigecycline issued by AD I&E
case of import). DRAP, Islamabad dated 05-08-2019 & 02-04-
2020.

sheets etc.

on product testing
accelerated).
3.2. S.4 • Acceptance limits for test of pH • Firm has submitted revised
submitted in the drug substance documents submitted without
specifications is not as per the USP justifying the deviations observed
monograph for “Tigecycline”. in previously submitted data.
• The details of coloumn • Temperature for autosampler not
temperature, mobile phase preparation, reflected in analytical method.
system suitability solution mentioned in • Firm has submitted Bioburden test
the Assay test method by Drug substance report from M/s Bio Lab for another
manufacturer is not as per the USP batch than that submitted earlier.
monograph for “Tigecycline”. • Drug substance specifications and
• Submitted COA from M/s Bio- analytical procedure has been
labs reflect that tests of Bacterial submitted from M/s Bio-Labs, but
Endotoxin & sterility have not been these documents are not formal and
performed. does not bear any document no.,
• Copies of the Drug substance issue date or effective date.
specifications and analytical procedures • Analytical method verification
used for routine testing of the Drug studies have been submitted from
substance /Active Drug Product M/s Bio-Labs.
manufacturer is required. • COA from API manufacturer has
• Analytical Method Verification been submitted, which declares the
studies including specificity, accuracy product name as “Tigecycline
and repeatability (method precision) lyophilized”, whereas COA of M/s
performed by the Drug Product Bio-Lab declares it as
manufacturer shall be submitted. “Tigecycline” only.
• Provide results of analysis of • No Evidence of availability of Auto
relevant batch(es) of Drug Substance sampler in HPLC, wherein 10oC
performed by Drug Product temperature conditions could be
manufacturer used during product maintained.
development and stability studies, along
with Certificate of Analysis (CoA) of the
same batch from Drug Substance /
/Active Pharmaceutical Ingredient
manufacture.
• Evidence of availability of Auto
sampler in HPLC, wherein 10oC
temperature conditions could be
maintained.
3.2.S.5 • COA of primary / secondary COA of working standard has been
reference standard including source and submitted from M/s Fuan
lot number shall be provided. Pharmaceutical, China.

condition as at refrigerated temperature, batches as submitted earlier, wherein
whereas stability studies data has been only conditions of storage have been
submitted as per room temperature changed as reuired for a refrigerated
conditions. item, while the analytical values for all
• Specifications for pH & specific the tests are same as presented earlier.
studies is different from that submitted in
section 3.2.S.4.4.
3.2.P.1 • Inclusion of lactose monohydrate MHRA approved reference given.
in the composition shall be justified since
innovator product approved by US FDA
& EMA is formulated without use of any
excipient.
formulated without use of any excipient.
3.2. P.5 • Specifications of• fillFollowing
weight/vialnot given
shall be submitted. • Specifications of fill weight/vial shall be submitted.
• • Evidence
Specifications does not include
of availability of Auto sampler in HPLC,
test of “Particulate matter”. wherein 10oC temperature conditions could be
• Evidence of availability
maintained.
of Auto
sampler in HPLC, •wherein 10oC
Peak integration is not proper, since it does not
temperature conditions coincide could with
be the base line.
maintained. • Documents are not formal and does not bear any
• Precision parameter document
has not beenno., issue date or effective date.
performed in the analytical method Submitted COAs does no tinclude test
verification studies. of particulate matter as recommended
• COAs of relevant batches for by the USP monograph of
which stability studies data has been “Tiogecycline for injection”
submitted, shall be provided.
3.2.P.6 • Submitted working standard COA of working standard submitted
COA reflect date of analysis as 14-12- with date of analysis as 25-12-2017,
2019, whereas stability batches have wherein the reference standard (lot#
been analysed prior to this date. F0M325) used for its standardization
3.2. P.8 • Firm has submitted• Invoicescopy shared
of are still subsequent to the date of
Licenses to Import Drugmanufacturingsubstance of two batches. i.e. L-131 & L-138
Tigecycline issued by AD with I&E manufacturing
DRAP, date of 03-2018, whereas
Islamabad dated 05-08-2019 submitted
& 02-04- invoice is of 08-2019.
2020, whereas stability• batchesSubmitted invoice is for “Tigecycline lyophilized”.
have
been manufactured prior•to theseFirm dates.
has submitted that provided data is of
• Clarification shall be submitted
commercial batches.
whether submitted stability• Raw studies
datadata
sheets submitted.
• Revised stability study sheets have been submitted.
is of trial batches or commercial batches.
• Raw data sheets for stability
studies, reflecting the details of Standard
weight, Sample dilution preparation,
Potency of Reference standard and
Calculation formula applied for the
Assay test shall be submitted.

• As per submitted stability studies
data, test of particulate matter has not
been performed, justification shall be
• Dates of testing written in the
stability summary sheets for different
time points, does not relate with the
relevant duration in months.
adjustment has not been done for the batch formula and now it sbeen
Drug substance, based upon the actual revised with potency adjustment as
Assay results. per potency of drug substance.
monohydrate has been used in the dispensed quantity of APi on the
formulation, whereas innovator product basis of 99% potency, whereas
has been formulated without use of any asper submitted COA of drug
excipient. Justification shall be submitted substance from M/s Bio-Labs, the
in this regard. potency of API is 98.4% on as is
capacity of the compounding vessel used • Submitted BMRs does not reflect
for manufacturing of stability batches any test of filled weight per vial,
shall be submitted shall be submitted. sterility testing at any stage.
• Submitted BMRs have not been Details of the minimum handling
filled completely. capacity of the compounding vessel
used for manufacturing of stability
maintained.

Firm’s reply:
• Submission of formal documents for Firm has submitted analytical procedure;
Labs, wherein details of document no., substance manufacturer.
been mentioned.
Evidence of availability of Auto sampler in Firm has submitted specifications of auto
HPLC, wherein 10oC temperature sampler assembled with HPLC of Perkin
conditions could be maintained. Almer 200LC, wherein operating
earlier.
lyophilized.
dosage.
is of 08-2019.
manufacture of finished drug product formulated into solution from which is

any stage

• Scientific justification shall be submitted for using glass beaker (5Ltr) for the compounding the
commercial scale batches as lyophilization is performed after filling the solution in vials.
• Verification of the claim of the firm regarding submitted HPLC chromatograms that “attenuation is
increased which results in the proper coinciding of baseline.”
Case no. 02 Registration applications of newly granted DML or New section (Human)
New DML
102. Name, address of Applicant / Marketing M/s Carer Pharmaceuticals plot No. 27 main
Authorization Holder RCCI road Rawat Industrial estate Islamabad
Pakistan.
Name, address of Manufacturing site. M/s Carer Pharmaceuticals plot No. 27 main
RCCI road Rawat Industrial estate Islamabad
Pakistan.
☐ Importer
giver)

☐ Export sale
The proposed proprietary name / brand name Clarithromycin 250mg/5ml Dry Powder
suspension.
Strength / concentration of drug of Active Each 5ml contains: Clarithromycin …….
Pharmaceutical ingredient (API) per unit 250mg
Pharmaceutical form of applied drug White to off white Powder filled in 60ml
Amber Glass Bottle.
Pharmacotherapeutic Group of (API) Macrolide (Antibiotics)
Proposed Pack size 60ml Dry Powder suspension.
The status in reference regulatory authorities USFDA Approved.
For generic drugs (me-too status) Klaricid 250mg suspension by M/s ABBOTT
Laboratories, Reg. No. 076148
GMP status of the Finished product New license granted on 07/06/2021
manufacturer Tablet, Capsule, Dry powder and ampoules
(General & General Antibiotic) section
approved.
Name and address of API manufacturer. M/S Vision Pharmaceuticals Plot No: 22-23,
Kahuta Industrial Triangle, Kahuta Rd,
Islamabad,
submitted.
substance

months
months
Batches: (CTM0510, CTM0511, CTM0513)
procedure (including dissolution testing at
acidic and buffer medium) and its verification
product.
dissolution profile established against the Klaricid Dry Powder by
ABBOTT Laboratories.
Analytical method validation/verification of Method verification studies have been
product submitted.
Manufacturer of API M/s Vision Pharmaceuticals Plot No: 22-23, Kahuta Industrial
Triangle, Kahuta Rd, Islamabad, 44000
API Lot No. CTM0681
Description of Pack
60ml Bottle
Batch No. T-001 T-002 T-003
Batch Size 500 Bottles 500 Bottles 500 Bottles
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. F. 3-26/2019
API manufacturer issued by concerned issued by DRAP valid till 10/02/2022.
3. Documents for the procurement of API with Local Purchase from M/S Vision
approval from DRAP (in case of import). Pharmaceuticals Plot No: 22-23, Kahuta
Industrial Triangle, Kahuta Rd, Islamabad.

chromatograms,
etc.
5. Compliance Record of HPLC software N/A
21CFR & audit trail reports on product testing
6. Record of Digital data logger for temperature Submitted
and humidity monitoring of stability
103. Name, address of Applicant / Marketing M/s Carer Pharmaceuticals plot No. 27
Authorization Holder main RCCI road Rawat Industrial estate
Islamabad Pakistan.
Name, address of Manufacturing site. M/s Carer Pharmaceuticals plot No. 27 main
RCCI road Rawat Industrial estate Islamabad
Pakistan.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand name Clarithromycin 125mg Dry Powder
Strength / concentration of drug of Active Each 5ml contains: Clarithromycin …….
Pharmaceutical ingredient (API) per unit 125mg
Pharmaceutical form of applied drug White to off white Powder filled in 60ml
Amber Glass Bottle.
Pharmacotherapeutic Group of (API) Macrolide (Antibiotics)
The status in reference regulatory authorities USFDA Approved.
For generic drugs (me-too status) Klaricid 125 mg suspension by M/s ABBOTT
manufacturer Tablet, Capsule, Dry powder and ampoules
(General & General Antibiotic) section
approved.
Name and address of API manufacturer. M/s Vision Pharmaceuticals Plot No: 22-23,
Kahuta Industrial Triangle, Kahuta Rd,
Islamabad,

submitted.
substance
months
months
Batches: (CTM0510, CTM0511, CTM0513)
product.
dissolution profile established against the Klaricid 125mg Dry
Powder by ABBOTT Laboratories.
Analytical method validation/verification of Method verification studies have been
product submitted.
Manufacturer of API M/s Vision Pharmaceuticals Plot No: 22-23, Kahuta Industrial
Triangle, Kahuta Rd, Islamabad, 44000
API Lot No. CTM0681
Description of Pack
60ml Bottle

Batch No. T-001 T-002 T-003
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. F. 3-26/2019
API manufacturer issued by concerned issued by DRAP valid till 10/02/2022.
3. Documents for the procurement of API with Local Purchase from M/S Vision
approval from DRAP (in case of import). Pharmaceuticals Plot No: 22-23, Kahuta
Industrial Triangle, Kahuta Rd, Islamabad.
chromatograms,
etc.
21CFR & audit trail reports on product testing
and humidity monitoring of stability

3.2.S.4.1 Copies of the Drug substance Submitted.
procedures used for routine testing
of the Drug substance /Active
3.2.S.4.4 • Submitted COA of Firm has submitted revised COA of batch#
Clarithromycin pellets form M/s CTM 0681, wherein date of manufacturing
Carer Pharma does not mention the has been corrected as per COA from M/s
batch# of drug substance. Vision Pharmaceuticals.
• Manufacturing date
mentioned on the COAs of drug
substance from M/s Vision pharma
& M/s Carer pharma are different.
• Provide results of analysis
of relevant batch(es) of Drug
studies, along with Certificate of
Analysis (CoA) of the same batch
from Drug Substance.

3.2.P.3.2 Justify the proposed quantity of Firm has justified the proposed quantity on
Clarithromycin per 5 ml in the basis of %age content fof the
submitted batch formula. Clarithromycin taste masked pellets used in
the formulation.
3.2.P.5.2 Detailed analytical procedures Firm has submitted drug product testing
used for testing the drug product method adopted by M/s Carer Pharma
shall be provided instead of based upon the USP monograph.
submitting the USP monograph
print.
3.2.P.5.3 Performance of precision Submitted.
parameter shall be submitted in the
analytical method verification
studies.
3.2.P.8 • Copy of commercial Firm has submitted copy of commercial
invoice for procurement of pellets invoice# 801551 from M/s Vision pharma
from M/s Vision shall be for procurement of 25 Kg Clarithromycin
submitted. taste masked pellets.
Decision: Registration Baord approved Clarithromycin 125mg Dry Powder & Clarithromycin
250mg/5ml Dry Powder suspension.
a. New Sections
104. Name, address of Applicant / M/s Jupiter Pharma. Plot No. 25, Street # S-6,
Marketing Authorization Holder National Industrial Zone, Rawat, Rawalpindi
Name, address of Manufacturing M/s Jupiter Pharma. Plot No. 25, Street # S-6, National
site. Industrial Zone, Rawat, Rawalpindi
☐ Importer
GMP status of the firm GMP certificate issued on basis of inspection conducted
on 18-11-2020.
manufacturing facility 27-06-2019, declaring grant following additional
sections:
“Capsule (Cephalosporin)
Dry powder suspension (Cephalosporin)
Dry Powder injection (Cephalosporin)”

The proposed proprietary name / Cetron 1gm IV Injection
brand name
Active Pharmaceutical ingredient Ceftriaxone as Sodium ………. 1gm
(API) per unit
Pharmaceutical form of applied drug Parenteral (Injectable)
Pharmacotherapeutic Group of (API) Third-Generation Cephalosporin’s
specifications
authorities
For generic drugs (me-too status) Triject IV 1gm Injection of M/s Nabiqasim
Name and address of API M/s Pharmagen Ltd., Ferozpur Road, Lahore
manufacturer.
Summary) template. Firm has summarized information related to
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of
(Conditions duration of Stability drug substance at both accelerated as well as real time
studies) conditions. The accelerated stability data is conducted at
40°C ± 2°C / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30°C ± 2°C / 65 ± 5% RH
for 36 months.
specifications, reference standard or materials, container

Comparative Dissolution Profile reference product of “Rocephin Injection 1gm” has been
submitted.
at both accelerated and long-term conditions.
Manufacturer of APIs M/s Pharmagen Ltd., Ferozpur Road, Lahore
API Lot No. 00421/014/2020
Description of Pack Type II glass vial
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20D04 20D05 20D06
1. Reference of previous approval
of applications with stability N/A
2. Approval of API/ DML/GMP GMP certificate issued on basis of inspection conducted on
certificate of API manufacturer 08-01-2019.
3. Documents for the procurement Copy of commercial invoice attested by AD I&E DRAP,
of API with approval from Karachi, has been submitted.
DRAP (in case of import).
Date of
Invoice Quantity
Batch No. approval
No. Imported
by DRAP
00421- 2540 10Kg N/A
03/014/2020 5.8 Kg
supported by attested respective Firm has submitted data of stability batches along with batch
documents like chromatograms, manufacturing record and analytical record.
Raw data sheets, COA,
monitoring of stability N/A
chambers

3.2. S.4.1 • Drug substance specifications • Firm has referred to the USP
submitted by M/s Jupiter Pharma monograph of ceftriaxone
declare specification’s reference sodium for Drug substance
as USP 43, whereas limits for specifications and has submitted
Assay test & Related substances revised specifications &
are not as per the USP monograph analutical procedure accordingly.
of “Ceftriaxone sodium”.
• Reference for specifications of
Assay test must be clarified by
Drug substance manufacturer,
whether it is USP or BP, since
both limits could not be applied.
3.2.S.4.3 • Chromatographic conditions Firm has submitted revised analytical
applied for the analytical method method verification report as per
validation is not as per those USP monograph.
recommended by USP
monograph for “Ceftriaxone
sodium”.
• Details of the performance of
specificity parameter have not
been submitted
3.2.S.5 Firm has submitted COA of working Firm has submitted COA of working
standard from M/s Pharmagen for standard from M/s Pharmagen valid
“Ceftriaxone sodium” which declares till January 2021.
the “use before date” as 19-11-2016,
whereas the stability batches have
been manufactured and analysed in
2020.
3.2.P.1 • Equivalency factor of the • Firm has justified the proposed
Ceftriaxone sodium shall be quantity per vial with reference to
defined for Ceftriaxone. the equivalency factor for sodium
• Reconstitution diluent has been salt.
submitted as 5ml Water for • Firm has submitted that it was a
Injection, which is not as typographic error and in
recommended by the reference commercialpacks same diluent
product. will be provided as recommended
by reference product i.e., 10ml
WFI.
3.2.P.3.5 • Submitted process validation • Firm has submitted revised
protocol does not identify Critical process validation protocol.
process parameters and critical
Quality attributes.
• Acceptable limits given in the
sampling plan are different from
that declared in section 3.2. P.5.1
3.2. P.5.1 • A signed copy of Drug product • Submitted.
procedure, used for the batch
release and stability studies of
applied product, shall be
submitted.
3.2.P.8 • Submit raw data sheets reflecting • Frim has submitted raw data
the details of Standard weight, sheets along with relevant
Sample weight, Dilution chormatograms for stabiltiy

preparation, Potency of studies.
Reference standard and • Frim has submitted revised
Calculation formula applied for BMRs decalring target fill weight
the Assay test. & correction of Line clearance
• Chromatograms for the complete details.
analysis of stability studies of
each batch have not been
submitted.
• Submitted BMR does not declare
the target fill weight/vial,
calculated on the basis of the
established potency of drug
substance.
• Submitted BMRs reflect the same
batch no. against the entry for
“Previous product” & “Clearance
granted for”, in the Line
clearance sheet of filling step.
Decision: Approved.
☐ Importer
on 18-11-2020.
manufacturing facility 27-06-2019, declaring grant following additional
sections:
The proposed proprietary name / Cetron 250mg IM Injection
brand name

Active Pharmaceutical ingredient Ceftriaxone as Sodium ………. 250mg
(API) per unit
specifications
authorities
For generic drugs (me-too status) Exit 250mg IV of M/s City Pharma
manufacturer.
batch analysis and stability studies of drug substance.
for 36 months.
Comparative Dissolution Profile reference product of “Oxidil Injection 250mg” has been
submitted.

API Lot No. 00421/014/2020

Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20D16 20D17 20D18
Batch Size 1287vials 1287 vials 1287 vials
of applications with stability Not submitted
Date of
Invoice Quantity
Batch No. approval
No. Imported
by DRAP
00421- 2540 10Kg N/A
03/014/2020 5.8 Kg
supported by attested respective Firm has submitted data of stability batches along with
documents like chromatograms, batch manufacturing record and analytical record.
chambers
Decision: Approved.

☐ Importer
conducted on 18-11-2020.
Evidence of approval of Firm has submitted copy of section approval letter
manufacturing facility dated 27-06-2019, declaring grant following additional
sections:
The proposed proprietary name / Cetron 250mg IV Injection
brand name
(API) per unit
specifications
authorities
For generic drugs (me-too status) Exit 250mg IV of M/s City Pharma
manufacturer.

validation, batch analysis and stability studies of drug
substance.
studies) conditions. The accelerated stability data is conducted
at 40°C ± 2°C / 75% ± 5% RH for 6 months. The real
time stability data is conducted at 30°C ± 2°C / 65 ±
5% RH for 36 months.
development, manufacture, manufacturing process and
process control, process validation protocols, control of
Comparative Dissolution Profile reference product of “Oxidil Injection 250mg” has
been submitted.
API Lot No. 00421/014/2020

Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20D13 20D14 20D15
Batch Size 1287vials 1287 vials 1287 vials

Date of
Invoice Quantity
Batch No. approval
No. Imported
by DRAP
00421- 2540 10Kg N/A
03/014/2020 5.8 Kg
for temperature & humidity
chambers


3.2. • Drug substance specifications • Firm has referred to the USP
S.4.1 submitted by M/s Jupiter Pharma monograph of ceftriaxone
declare specification’s reference as USP sodium for Drug substance
43, whereas limits for Assay test & specifications and has submitted
Related substances are not as per the revised specifications &
USP monograph of “Ceftriaxone analutical procedure
sodium”. accordingly.
• Reference for specifications of Assay
test must be clarified by Drug substance
manufacturer, whether it is USP or BP,
since both limits could not be applied.
3.2.S.4.3 • Chromatographic conditions applied for • Firm has submitted revised
the analytical method validation is not analytical method verification
as per those recommended by USP report as per USP monograph.
monograph for “Ceftriaxone sodium”.
• Details of the performance of specificity
parameter have not been submitted
3.2.S.4.4 • Submitted COA of drug substance from • Firm has submitted revised
M/s Jupiter does not declare the results COA wherein limts for
for the tests of “Sterility” & “Bacterial description have been corrected,
Endotoxin”. test of BET & Sterility has been
• Limits for the test of included along with result for
“Description/Appearance” is different Assay test has as per the USP
between the COA of M/s Pharmagen & specifications.
M/s Jupiter. • Submitted.
• Submit analytical record i.e.,
Chromatograms, FTIR spectrum and
raw data sheets for the drug substance
analysis performed by M/s Jupiter
pharma
3.2.S.5 Relevant information has not been Firm has submitted COA of
submitted. working standard from M/s
Pharmagen for “Ceftriaxone
sodium” which declares the “use
before date” as 19-11-2016,
whereas the stability batches have
been manufactured and analysed in
2020.
3.2. P.1 • Equivalency factor of the Ceftriaxone • Firm has justified the proposed
sodium shall be defined for Ceftriaxone. quantity per vial with reference
to the equivalency factor for
sodium salt.
3.2. • Submitted process validation protocol • Firm has submitted revised
P.3.5 does not identify Critical process process validation protocol.
parameters and critical Quality
attributes.
• Acceptable limits given in the sampling
plan are different from that declared in
section 3.2. P.5.1
3.2. • A signed copy of Drug product • Firm has submitted copy of
P.5.1 specifications and analytical procedure, Drug product specifications &

used for the batch release and stability analytical procedure as per USP
studies of applied product, shall be monograph.
submitted.
• Submitted specification does not
include test of “Constituted solution”.
• Submitted specifications mention only
one Assay limit of 90- 115%, whereas
USP monograph of “Ceftriaxone for
injection” mandates two Assay limits.
3.2. • The concentration of standard solution • Firm has submitted revised
P.5.3 mentioned in the analytical procedure is analytical method verification
not as per the USP monograph of report as per USP monograph.
“Ceftriaxone for injection”.
• Parameter of specificity test mentions
the use of placebo. You are advised to
clarify the composition of placebo.
3.2.P.8 • Submitted stability studies report reflect • We have just filled the raw
that Assay test has been performed for material in glass vials. Before
reconstituted injection only, whereas filling the raw material is
USP monograph of “Ceftriaxone for completely teste. And during
injection” also requires performance of stability studies all the test
another Assay test with acceptance limit paarmeters were found within
of “Ceftriaxone for Injection contains acceptable limits.
an amount of Ceftriaxone Sodium • Reports of the microbiological
equivalent to NLT 776 µg/mg of testing for the tests of “Sterility”
Ceftriaxone.” Justification shall be and “Bacterial Endotoxin” have
submitted in this regard. been submitted.
• Submit raw data sheets reflecting the • Firm has submitted raw data
details of Standard weight, Sample sheets along with relevant
weight, Dilution preparation, Potency chormatograms for stabiltiy
of Reference standard and Calculation studies.
formula applied for the Assay test. • Firm has submitted revised
• Chromatograms for the complete BMRs decalring target fill
analysis of stability studies of each weight.
batch have not been submitted.
• Reports of the microbiological testing
for the tests of “Sterility” and “Bacterial
Endotoxin” have not been submitted.
• Submitted BMR does not declare the
target fill weight/vial, calculated on the
basis of the established potency of drug
substance..
Decision: Approved.

Name, address of Manufacturing M/s Jupiter Pharma. Plot No. 25, Street # S-6,
site. National Industrial Zone, Rawat, Rawalpindi
☐ Importer
giver)
manufacturing facility dated 27-06-2019, declaring grant following
additional sections:
Details of fee submitted Rs.20,000/- dated 05-01-2021 & Rs.10,000/-
dated 27-05-2021
The proposed proprietary name / Cetron 2gm IV Injection
brand name
Active Pharmaceutical ingredient Ceftriaxone as Sodium ………. 2gm
(API) per unit
specifications
authorities
For generic drugs (me-too status) Triject IV 1gm Injection of M/s Nabiqasim
manufacturer.
Summary) template. Firm has summarized information

product.
(Conditions duration of Stability batches of drug substance at both accelerated as
studies) well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75% ±
5% RH for 6 months. The real time stability data
is conducted at 30°C ± 2°C / 65 ± 5% RH for 36
months.
stability.
Comparative Dissolution Profile reference product of “Oxidil 2gm IV” has been
submitted.
conditions.
API Lot No. 00421/014/2020
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20D01 20D02 20D03

2. Approval of API/ DML/GMP GMP certificate issued on basis of inspection
certificate of API manufacturer conducted on 08-01-2019.
3. Documents for the procurement Copy of commercial invoice attested by AD I&E
of API with approval from DRAP,
DRAP (in case of import). Karachi, has been submitted.
Date of
Invoice Quantity
Batch No. approval
No. Imported
by DRAP
00421- 2540 10Kg N/A
03/014/2020 5.8 Kg
for temperature & humidity Firm has submitted Record of Digital data logger for
monitoring of stability temperature & humidity monitoring of stability
chambers chambers (real time and accelerated)
3.2. S.4.1 • Drug substance • Firm has referred to the USP
specifications submitted monograph of ceftriaxone sodium
by M/s Jupiter Pharma for Drug substance specifications
declare specification’s and has submitted revised
reference as USP 43, specifications & analutical
whereas limits for Assay procedure accordingly.
test & Related substances
are not as per the USP
monograph of
“Ceftriaxone sodium”.
• Reference for
specifications of Assay
test must be clarified by
Drug substance
manufacturer, whether it is
USP or BP, since both
limits could not be
applied.
3.2.S.4.4 • Submitted COA of drug • Firm has submitted revised COA
substance from M/s wherein limts for description have
Jupiter does not declare been corrected, test of BET &
the results for the tests of Sterility has been included along
“Sterility” & “Bacterial with result for Assay test has as
Endotoxin”. per the USP specifications.
• Limits for the test of • Submitted.
“Description/Appearance”
is different between the
COA of M/s Pharmagen &
M/s Jupiter.
• Submit analytical record
i.e., Chromatograms,
FTIR spectrum and raw
data sheets for the drug
substance analysis
performed by M/s Jupiter
pharma
3.2.S.5 Relevant information has not Firm has submitted COA of working
been submitted. standard from M/s Pharmagen valid
till January 2021.
3.2.P.1 • Reconstitution diluent has • Firm has submitted that it was a
been submitted as 5ml typographic error and in
Water for Injection, which commercialpacks same diluent
is not as recommended by will be provided as recommended
the reference product. by reference product i.e., 10ml
WFI.
3.2.P.3.5 • Submitted process • Firm has submitted revised
validation protocol does process validation protocol.
not identify Critical
process parameters and
critical Quality attributes.
• Acceptable limits given in
the sampling plan are
different from that
declared in section 3.2.
P.5.1
3.2. P.5.1 • A signed copy of Drug • Firm has submitted drug product
product specifications and analytical method, as per the USP
analytical procedure, used monograph of “Cefrtriaxone for
for the batch release and injection”.
stability studies of applied
product, shall be
submitted.
• Submitted specification
does not include test of
“Constituted solution”.
• Submitted specifications
mention only one Assay
limit of 90- 115%,
whereas USP monograph
of “Ceftriaxone for
injection” mandates two
Assay limits.
3.2. P.5.3 • The concentration of • Firm has submitted revised
standard solution analytical method verification
mentioned in the report as per USP monograph.
analytical procedure is not
as per the USP monograph
of “Ceftriaxone for

injection”.
• Parameter of specificity
test mentions the use of
placebo. You are advised
to clarify the composition
of placebo.
3.2.P.8 • Submitted stability studies • We have just filled the raw
report reflect that Assay material in glass vials. Before
test has been performed filling the raw material is
for reconstituted injection completely teste. And during
only, whereas USP stability studies all the test
monograph of paarmeters were found within
“Ceftriaxone for acceptable limits.
injection” also requires • Reports of the microbiological
performance of another testing for the tests of “Sterility”
Assay test with acceptance and “Bacterial Endotoxin” have
limit of “Ceftriaxone for been submitted.
Injection contains an • Frim has submitted raw data
amount of Ceftriaxone sheets along with relevant
Sodium equivalent to NLT chormatograms for stabiltiy
776 µg/mg of studies.
Ceftriaxone.” Justification • Frim has submitted revised BMRs
shall be submitted in this decalring target fill weight.
regard.
• Submit raw data sheets
reflecting the details of
Standard weight, Sample
weight, Dilution
preparation, Potency of
Reference standard and
Calculation formula
applied for the Assay test.
• Chromatograms for the
complete analysis of
stability studies of each
batch have not been
submitted.
• Reports of the
microbiological testing for
the tests of “Sterility” and
“Bacterial Endotoxin”
have not been submitted.
• Submitted BMR does not
declare the target fill
weight/vial, calculated on
the basis of the established
potency of drug substance.
• No fee has been submitted for the submitted variations.

issued after submission of fee that is Rs. 7,500/- for revision of specifications as per
☐ Importer
giver)
The proposed proprietary name / Cetron 500mg IM Injection
brand name
(API) per unit
specifications
authorities
For generic drugs (me-too status) El-cef Injection 500mg IM of M/s Linear
Pharmaceuticals.
manufacturer.

product.
analysis and stability studies of drug substance.
months.
stability.
Comparative Dissolution Profile reference product of “Rocephin Injection 500mg”
has been submitted.
conditions.
API Lot No. 00421/014/2020

Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency

Batch No. 20D10 20D11 20D12
Date of
Invoice Quantity
Batch No. approval
No. Imported
by DRAP
00421- 2540 10Kg N/A
03/014/2020 5.8 Kg
Firm has submitted audit trail reports on product
testing.
chambers
Decision: Approved.
☐ Importer
giver)

The proposed proprietary name / Cetron 500mg IV Injection
brand name
(API) per unit
specifications
authorities
For generic drugs (me-too status) Cefnig Injection 500mg (Ceftriaxone as sodium)
of M/s Global Pharmaceuticals.
manufacturer.
product.

months.
stability.
Comparative Dissolution Profile reference product of “Rocephin Injection 500mg”
has been submitted.
conditions.
API Lot No. 00421/014/2020

Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20D07 20D08 20D09

Date of
Invoice Quantity
Batch No. approval
No. Imported
by DRAP
00421- 2540 10Kg N/A
03/014/2020 5.8 Kg
chambers

3.2.S.4.1 • Drug substance specifications • Firm has referred to the USP
submitted by M/s Jupiter Pharma monograph of ceftriaxone sodium
declare specification’s reference as for Drug substance specifications
USP 43, whereas limits for Assay and has submitted revised
test & Related substances are not as specifications & analutical
per the USP monograph of procedure accordingly.
“Ceftriaxone sodium”.
• Reference for specifications of
Assay test must be clarified by
Drug substance manufacturer,
whether it is USP or BP, since both
limits could not be applied.
3.2.S.4.3 • Chromatographic conditions Firm has submitted revised analytical
applied for the analytical method method verification report as per USP
validation is not as per those monograph.
recommended by USP monograph
for “Ceftriaxone sodium”.
• Details of the performance of
specificity parameter have not been
submitted
3.2.S.4.4 • Submitted COA of drug substance • Firm has submitted revised COA
from M/s Jupiter does not declare wherein limits for description have
the results for the tests of been corrected, test of BET &
“Sterility” & “Bacterial Sterility has been included along
Endotoxin”. with result for Assay test has as per
• Limits for the test of the USP specifications.
“Description/Appearance” is • Submitted.
different between the COA of M/s
Pharmagen & M/s Jupiter.

Chromatograms, FTIR spectrum
and raw data sheets for the drug
substance analysis performed by
M/s Jupiter pharma
3.2.P.1 Equivalency factor of the Ceftriaxone • Firm has justified the proposed
sodium shall be defined for quantity per vial with reference to
Ceftriaxone. the equivalency factor for sodium
salt.
• Firm has submitted that it was a
typographic error and in
commercialpacks same diluent will
be provided as recommended by
reference product i.e., 10ml WFI.
3.2.P.3.5 • Submitted process validation Firm has submitted revised process
protocol does not identify Critical validation protocol.
process parameters and critical
Quality attributes.
• Acceptable limits given in the
sampling plan are different from
that declared in section 3.2. P.5.1
3.2. P.5.1 • A signed copy of Drug product Revised drug product specification sand
specifications and analytical analytical procedure has been submitted
procedure, used for the batch as per USP momnograph.
applied product, shall be submitted.
• Submitted specification does not
include test of “Constituted
solution”.
• Submitted specifications mention
only one Assay limit of 90- 115%,
whereas USP monograph of
“Ceftriaxone for injection”
mandates two Assay limits.
3.2. P.5.3 • The concentration of standard Firm has submitted revised analytical
solution mentioned in the method verification report as per USP
analytical procedure is not as per monograph.
the USP monograph of
“Ceftriaxone for injection”.
• Parameter of specificity test
mentions the use of placebo. You
are advised to clarify the
composition of placebo.
3.2. P.5.4 • Batch size mentioned on submitted Firm has declared it typographical error
COAs is different from that and has submitted revised COAs.
declared in BMRs.
3.2.P.8 • Submitted stability studies report • We have just filled the raw material
reflect that Assay test has been in glass vials. Before filling the raw
performed for reconstituted material is completely teste. And
injection only, whereas USP during stability studies all the test
monograph of “Ceftriaxone for paarmeters were found within
injection” also requires acceptable limits.
performance of another Assay test • Reports of the microbiological
with acceptance limit of testing for the tests of “Sterility” and

“Ceftriaxone for Injection contains “Bacterial Endotoxin” have been
an amount of Ceftriaxone Sodium submitted.
equivalent to NLT 776 µg/mg of • Frim has submitted raw data sheets
Ceftriaxone.” Justification shall be along with relevant chormatograms
submitted in this regard. for stabiltiy studies.
• Chromatograms for the 6th month • Frim has submitted revised BMRs
time point of stability studies of decalring target fill weight.
batch no. 20D07 has not been
submitted.
• Submit raw data sheets reflecting
the details of Standard weight,
Sample weight, Dilution
preparation, Potency of Reference
standard and Calculation formula
applied for the Assay test.
• Chromatograms for the complete
batch# 20D08 have not been
submitted.
• Chromatograms for the complete
batch# 20D09 have not been
submitted.
• Repots of the microbiological
testing for the tests of “Sterility”
and “Bacterial Endotoxin” have not
been submitted.
• Submitted BMR does not declare
the target fill weight/vial,
calculated on the basis of the
established potency of drug
substance.
Decision: Approved.
110. Name, address of Applicant / M/s Jupiter Pharma. Plot No. 25, Street # S-6, National
Marketing Authorization Holder Industrial Zone, Rawat, Rawalpindi
☐ Importer
on 18-11-2020.
manufacturing facility 27-06-2019, declaring grant following additional sections:


The proposed proprietary name / M-Xime 100mg/5ml Dry Suspension
brand name
Strength / concentration of drug of Each 5ml of reconstituted suspension contains:
Active Pharmaceutical ingredient Cefixime as Trihydrate ……… 100mg
(API) per unit
Pharmaceutical form of applied drug Dry suspension oral
specifications
Proposed Pack size 1’s x 30ml
authorities
For generic drugs (me-too status) Cefspan DS dry suspension of M/s Barret Hodgson
Karachi (Reg.#024634)
manufacturer.
Summary) Firm has summarized information related to
drug substance.

for 36 months.
Pharmaceutical Equivalence and Pharmaceutical Equivalence Studies against the reference
Comparative Dissolution Profile product of “Cefspan dry suspension of M/s Barret
Hodgson Karachi” has been submitted.
API Lot No. 004243/022/2020

Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20DST04 20DST05 20DST06
Batch Size 200 bottles 200 bottles 200 bottles
applications with stability study N/A
3. Documents for the procurement of Copy of commercial invoice for 10Kg of Cefixime
API with approval from DRAP (in (micronized) has been submitted.
case of import).
data sheets etc.

111. Name, address of Applicant / M/s Jupiter Pharma. Plot No. 25, Street # S-6, National
Marketing Authorization Holder Industrial Zone, Rawat, Rawalpindi
☐ Importer
on 18-11-2020.
manufacturing facility 27-06-2019, declaring grant following additional sections:
The proposed proprietary name / M-Xime Plus 200mg/5ml Dry Suspension 30ml
brand name
Strength / concentration of drug of Each 5ml of reconstituted suspension contains:
Active Pharmaceutical ingredient Cefixime as Trihydrate ……… 200mg
(API) per unit
Pharmaceutical form of applied drug Dry suspension oral
specifications
Proposed Pack size 1’s x 30ml
authorities
For generic drugs (me-too status) Cefspan DS dry suspension of M/s Barret Hodgson
manufacturer.

drug substance.
for 36 months.
Pharmaceutical Equivalence and Pharmaceutical Equivalence Studies against the reference
Comparative Dissolution Profile product of “Cefspan DS dry suspension of M/s Barret
Hodgson Karachi” has been submitted.
API Lot No. 004243/022/2020

Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 20DST04 20DST05 20DST06
Batch Size 200 bottles 200 bottles 200 bottles

applications with stability study N/A
3. Documents for the procurement of Copy of commercial invoice for 10Kg of Cefixime
API with approval from DRAP (in (micronized) has been submitted.
case of import).
data sheets etc.

3.2. S.4.3 • Details of the performance of Performance of specificty parameter
specificity parameter have not been has been submitted.
submitted
3.2. S.4.4 • Limits for the test of Firm has submitted revised COA along
“Description/Appearance” & with analytical record.
Assay are different between the
COA of M/s Pharmagen & M/s
Jupiter.
Chromatograms, FTIR spectrum
and raw data sheets for the drug
substance analysis performed by
M/s Jupiter pharma
3.2. S.5 Relevant information has not been COA of USP reference standard of
submitted. cefixime has been submitted.
3.2.P.2.5 • Quantities of preservatives used in • Firm has referred to literature from
formulation shall be justified for hand book of pharmaceutical
per unit dose with reference to the excipients as rationale for the
relevant guidelines/standards. quantities of preservative used.
• Preservative effectiveness studies • Microbial enumeration report has
to be performed as per been submitted for preservative
recommendations of effectiveness studies.
pharmacopoeia shall be provided
3.2. P.5.1 • A signed copy of Drug product Firm has submitted revised drug
specifications and analytical product analytical procedure including
procedure, used for the batch test of preservative effectiveness.
applied product, shall be submitted.
• Test for content of antimicrobial

preservative & efficacy of
preservative, as recommended by
ICH Q1 (R2) guidelines & USP
chapter <51>, has not been
included in the finished product
specifications. You are advised to
submit justification in this regard.
3.2. P.5.6 • This section refers to JP Firm has declared it a typographic error
specifications, whereas section and has referred to USP monograph as
3.2.P.5.1 declares finished product drug product specifications.
specifications of USP standard.
3.2. P.6 • COA of primary / secondary COA of USP reference standard of
reference standard including source cefixime has been submitted for Lot#
and lot number shall be provided. G01139
3.2. P.8 • Chromatograms for the 6 month • Firm has submitted analytical record
th
time point of stability studies have including raw data sheets and
not been submitted. chromatograms for 6th moth time
• Submitted Chromatograms are not point also.
readable, hence a clear readable • Firm has justified the dispensed
copy of chromatograms shall be quantity of cefixime against the
submitted. theoretical factor for hydrate form.
• Test for content of antimicrobial • Firm ha submitted 14 days- in-use
preservative & efficacy of stability study report for the
preservative, as recommended by reconstituted suspension.
ICH Q1 (R2) guidelines, has not
been performed during stability
studies. You are advised to submit
justification in this regard.
• Summary of additional stability
studies i.e., in-use studies re-
constituted product, along with
proposed in-use storage statement
and in-use shelf-life shall be
provided.
• Justify the quantity of API
dispensed for each trial batch,
considering the declared potency
and equivalency factor of API.
Decision: Registration Baord approved M-Xime 100mg/5ml Dry Suspension & M-Xime Plus
200mg/5ml Dry Suspension.
112. Name, address of Applicant / Marketing M/s Variant pharmaceuticals (Pvt) Ltd, Plot
Authorization Holder No. 5, M-2, Pharmazone, 26 Km, Lahore
Sharikpur Road, Sheikhupura.
Name, address of Manufacturing site. M/s Variant pharmaceuticals (Pvt) Ltd, Plot No.
5, M-2, Pharmazone, 26 Km, Lahore Sharikpur
Road, Sheikhupura.

☐ Importer
giver)
☐ Export sale
☒Domestic and Export sales
Details of fee submitted PKR 30,000/-: 06-12-2021,
DEXIRANT 30mg Capsules
name
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole (as dual delayed release
pellets)………30mg
Pharmaceutical form of applied drug Capsules
Pharmacotherapeutic Group of (API) Proton pump inhibitor
specifications
The status in reference regulatory DEXILANT 30mg Capsule of M/s TAKEDA
authorities PHARMS USA
(USFDA approved)
For generic drugs (me-too status) Razodex 30 mg Capsule of M/s GETZ Pharma
(Reg # 086976)
manufacturer General Tablet, General Capsule, General Sachet
and General dry powder injectable (pre-
lyophilized)
Name and address of API manufacturer. M/s Vision pharmaceuticals (pvt) Ltd., Plot no.
22-23, Industrial Triangle, Kahuta Road,
Islamabad
submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data

Stability studies Firm has submitted stability study data of 6
months accelerated and 36 months real time data
of 3 batches of API.
months of 3 batches
months of 3 batches
and stability.
comparative dissolution profile equivalence of test formulation with comparator
product DEXILANT 30mg Capsule (B # 511014)
of M/s Takeda GmbH, Germany by performing
all the quality tests including dissolution in 3
different media (pH 1.2, 5.5 and 7). The results of
the tests of both products were found to be within
the specifications and are comparable.
Analytical method validation/verification of Firm has submitted report of verification studies
product of analytical method for the drug substance. Firm
has submitted report of validation of analytical
method for the drug product.
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad.
API Lot No. DLP755
Description of Pack
30’s blisters packed in unit carton
Batch No. VT-001 VT-002 VT-003
Batch Size 1000 caps 1000 caps 1000 caps

No. of Batches 03
1. Reference of previous approval of The firm has not submitted any response.
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate
API manufacturer issued by concerned for M/s Vision pharma pvt Ltd, Lahore issued by
regulatory authority of country of origin. DRAP Lahore. It is valid till 10-02-2022.
3. Documents for the procurement of API with The firm has submitted copy of invoice for the
approval from DRAP (in case purchase of esomeprazole sodium sterile powder
of import). (2kg, Batch # DLP755) from M/s vision pharma
vide invoice # 703069 dated 19-04-2021.
4. Data of stability batches will be supported by
chromatograms, Submitted
etc.
21CFR & audit trail reports on product Submitted
testing
Submitted
accelerated)
Observation Response by the firm
Submission of analytical method Submitted from M/s Variant
verification studies for drug substance pharmaceuticals.
performed by drug product manufacturer is
required.
Analytical method for routine analysis of Submitted.
drug substance used by the drug product
manufacturer is required to be submitted.
Please submit documents confirming the Firm has submitted copy of commetcial
procurement of drug substance for invoice for procurement of 2 Kg of
manufacturing of the applied product. Dexlansoprazole DDR pellets 22.5% from /s
Vision pharmaceuticals.
In method validation studies for drug Firm has submitted concentration in terms of
product, the exact amount of contents of mg/ml for performance of each parameter of
capsule have not been mention equivalent to method validation.
60mg or 30mg dexlansoprazole, please
submit complete method for analytical
method validation studies including the
exact amount of contents of capsule
(pellets)taken for preparation of dilutions.
Justification of specification for Firm has submitted drug product
Dexlasoprazole capsule 30/60mg has not specification for both 30mg & 60 mg
been provided in submitted dossier. capsule.
However, justification of specification for
another dosage form is presented in the

dossier, clarify or otherwise submit the
required data.
Please provide complete calculations for Firm has submitted details for weight of
potency adjustment of 30/60mg capsule. pellets per capsule calculated on basis of
“As is potency” of Dexlansoprazole pellets.
Since similar batch numbers have been Firm has submitted SOP for issuance of
assigned to stability batches of 30mg and BMR”.
60mg capsules, therefore, the internal SOP/
procedure for assigning the batch numbers is
required with the clarification of the same.
113. Name, address of Applicant / Marketing M/s Variant pharmaceuticals (Pvt) Ltd, Plot
Authorization Holder No. 5, M-2, Pharmazone, 26 Km, Lahore
Sharikpur Road, Sheikhupura.
Name, address of Manufacturing site. M/s Variant pharmaceuticals (Pvt) Ltd, Plot No.
5, M-2, Pharmazone, 26 Km, Lahore Sharikpur
Road, Sheikhupura.
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 30,000/-: 06-12-2021,
DEXIRANT 60mg Capsules
name
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole (as dual delayed release
pellets)………60mg
Pharmaceutical form of applied drug Capsules
Pharmacotherapeutic Group of (API) Proton pump inhibitor
In-House
specifications
The status in reference regulatory DEXILANT 60mg Capsule of M/s TAKEDA
authorities PHARMS USA (USFDA approved)
For generic drugs (me-too status) Razodex 60 mg Capsule of M/s GETZ Pharma
(Reg # 086976)
lyophilized)

Name and address of API manufacturer. M/s Vision pharmaceuticals (pvt) Ltd., Plot no.
Islamabad
submitted.
months accelerated and 36 months real time data
of 3 batches of API.
months of 3 batches
months of 3 batches
Batches: (DLP123T, DLP124T, DLP125T)
and stability.
comparative dissolution profile equivalence of test formulation with comparator
product DEXILANT 60mg Capsule (B # 510902)
of M/s Takeda GmbH, Germany by performing
all the quality tests including dissolution in 3
different media (pH 1.2, 5.5 and 7). The results of
the tests of both products were found to be within
the specifications and are comparable.
Analytical method validation/verification of Firm has submitted report of verification studies
product of analytical method for the drug substance. Firm

has submitted report of validation of analytical
method for the drug product.
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle,
Kahuta Road, Islamabad.
API Lot No. DLP755
Description of Pack
30’s blisters in alu alu blister packed in unit carton
Batch No. VT-001 VT-002 VT-003
Batch Size 1000 caps 1000 caps 1000 caps
No. of Batches 03
1. Reference of previous approval of The firm has not submitted any response.
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate
API manufacturer issued by concerned for M/s Vision pharma pvt Ltd, Lahore issued by
regulatory authority of country of origin. DRAP Lahore. It is valid till 10-02-2022.
3. Documents for the procurement of API with The firm has submitted copy of invoice for the
approval from DRAP (in case purchase of esomeprazole sodium sterile powder
of import). (2kg, Batch # DLP755) from M/s vision pharma
vide invoice # 703069 dated 19-04-2021.
4. Data of stability batches will be supported by
etc.
testing
Submitted
accelerated)
Observation Response by the firm
Submission of analytical method Submitted from M/s Variant
verification studies for drug substance pharmaceuticals.
performed by drug product manufacturer is
required.

Analytical method for routine analysis of Submitted.
drug substance used by the drug product
manufacturer is required to be submitted.
Please submit documents confirming the Firm has submitted copy of commetcial
procurement of drug substance for invoice for procurement of 2 Kg of
manufacturing of the applied product. Dexlansoprazole DDR pellets 22.5% from
/s Vision pharmaceuticals.
In method validation studies for drug Firm has submitted concentration in terms
product, the exact amount of contents of of mg/ml for performance of each
capsule have not been mention equivalent to parameter of method validation.
60mg or 30mg dexlansoprazole, please
submit complete method for analytical
method validation studies including the
exact amount of contents of capsule
(pellets)taken for preparation of dilutions.
Justification of specification for Firm has submitted drug product
Dexlasoprazole capsule 30/60mg has not specification for both 30mg & 60 mg
been provided in submitted dossier. capsule.
However, justification of specification for
another dosage form is presented in the
dossier, clarify or otherwise submit the
required data.
Please provide complete calculations for Firm has submitted details for weight of
potency adjustment of 30/60mg capsule. pellets per capsule calculated on basis of
“As is potency” of Dexlansoprazole pellets.
Since similar batch numbers have been Firm has submitted SOP for issuance of
assigned to stability batches of 30mg and BMR”.
60mg capsules, therefore, the internal SOP/
procedure for assigning the batch numbers is
required with the clarification of the same.
Decision: Registration Board approved DEXIRANT 30mg Capsules & DEXIRANT 60mg
Capsules.
Case No. 04 Registration applications of import cases

a. New cases
Priority Registration Applications

Drug Regulatory Authority of Pakistan in its 129th meeting held on 17th February, 2022 discussed
the case regarding “Priority Consideration of Applications for Registration Submitted After
Cancellation of Their Renewal of Registration” vide Agenda Item No.V:. Wherein, the
Authority decided as under;
“The Authority acceded to the request of firms for out-of-queue submission and consideration
of registration dossiers on CTD Format (5F) in regard to cancelled products due to late
submission of renewals.”

Accordingly, M/s Graton Pharma., Suit No.501 and 502 fifth floor plot No. 42C/2lane 8 bukhari
commercial DHA phase 6, Karachi-75500, Pakistan. has requested for priority consideration of
their following products due to invalid registration status of previously registered product:
114. Name, address of Applicant / Importer M/s Graton Pharma., Suit No.501 and 502 fifth
floor plot No. 42C/2lane 8 bukhari commercial
DHA phase 6, Karachi-75500, Pakistan.
Address: Office No.501 and 502 fifth floor plot
No. 42C/2lane 8 Bukhari commercial DHA phase
6, Karachi-75500, Pakistan.
Address of Godown: --
Validity: 21-10-2023.
Status: License to sell, stock and exhibit for sale,
distribute and sell drugs by way of whole sale.
Name and address of marketing Beijing Beilu Pharmaceutical Co., Ltd. No. 3
authorization holder (abroad) Shuiyuan West Road, Miyun District, Beijing
China
Name, address of manufacturer(s) Beijing Beilu Pharmaceutical Co., Ltd. Miyun
Industrial Development Area., Beijing.
Detail of certificates attached (CoPP, Free CoPP: Firm has submitted copy of legalized CoPP
sale certificate, GMP certificate) certificate (No. Beijing20210129) issued by
Beijing Municipal Medical Products
Administration No. 70 Zaolinqian Street,
Xicheng District Bejing for Iohexol 50ml: 17.5g
(I) Injection. The CoPP confirms free sale status of
the product in exporting country as well as GMP
status of the manufacturing site through periodic
inspections.
The name of importing country on CoPP is
mentioned as Pakistan.
Copy of GMP certificate no. BJ20180345 valid
upto 08-08-2023 has been submitted for Beijing
Beilu Pharmaceutical Co., Ltd. Miyun Industrial
Development Area., Beijing.
Details of letter of authorization / sole Firm has submitted original product specific
agency agreement authority letter from Beijing Beilu Pharmaceutical
Co., Ltd. Address 7th Floor, Block Maples
International office, No. 32 Xizhimen North
Street, Haidian District, Beijing City, PR. China in
the name of M/s Graton Pharma., Suit No.501 and
502 fifth floor plot No. 42C/2lane 8 bukhari
commercial DHA phase 6, Karachi-75500,
Pakistan. for following products
Iohexol Injection 100ml:35g(I)
Iohexol Injection 50ml:17.5g(I)
This letter of appointment is valid upto 30-04-2026

unless revoked earlier.
☒ Importer

☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 808, Date of submission: 13-05-2022
Details of fee submitted PKR 75,000/- vide Deposit Slip
No:709132227594
The proposed proprietary name / brand MONOPAQUE 50ml injection (Iohexol Injection
name (50ml: 17.5g (I))
Strength / concentration of drug of Active Each ml contains 755 mg of Iohexol equivalent to
Pharmaceutical ingredient (API) per unit 350mg of Iodine.
Pharmaceutical form of applied drug Injection
Pharmacotherapeutic Group of (API) Medical Imaging drug
specifications
The status in reference regulatory OMNIPAQUE 350 mg iodine/ml (755 mg of
authorities iohexol/mL), (50ml=17.5g I), Solution for
injection USFDA Approved by M/s Healthcare
United States
For generic drugs (me-too status) IOBRIX-350 INJECTION 50ml by M/s Hoffmann
Human Health Pak Ltd (Reg#032137)
product.
Name, address of drug substance Zhejiang Hichi Pharmaceutical Co., Ltd., Binhai
manufacturer Road, Damaiyu Economic Development Zone,
Yuhuan County, Zhejiang China
process and controls of material, control of critical

steps and intermediates, impurities, specifications,
Stability Studies of Drug Substance Stability study conditions:
(Conditions & duration of Stability Real time: 30°C ± 2°C / 65% ± 5%RH for 36
studies) months
months
development, manufacturers, manufacturing
process and control of critical steps validation
characterization of impurities, justification of
Pharmaceutical Equivalence Pharmaceutical equivalence performed against
reference product having strength 100ml:35g
Iohexol injection
of product studies for the test of related substances in the
applied product since titration method is applied
for Assay test.
Container closure system of the drug Medium Borosilicate glass type-I infusion bottles,
product halogenated butyl rubber stopper (chlorinated) for
injections, and aluminum plastic combined caps
for infusion bottles
life and storage conditions batches. The accelerated stability study data is
conducted at 30oC ±2oC / 65% ± 5% RH. The real
time stability study data of 2 batches (190907 and
190908) is for 18 months only while the stability
study data for 3rd batch (190909) is for 36 months.
Batch No. Mfg. Date

190907 10-09-2019
190908 10-09-2019
190909 11-09-2019
Remarks of Evaluator XI:
Section Observations Response
1.1 • The applied drug product is a generic • Firm has submitted differential fee of Rs.
drug product and you have submitted 75,000/- vide deposit slip# 12552911.
fee 75000/- only. Submit differential
fee for the applied product

• Address of the Product license • Firm has submitted declaration that our
holder/exporter on authority letter manufacturing License address is now
and CoPP are different from each described as “No.3 Shuiyuan West Road,
other. Clarification is required. Miyun District, Beijing”, which refers to
the same place that described in the address
written in the GMP certificate which is
“Miyun Industrial Development Area,
Beijing”.
1.4.1 • All the information related to type of Submitted.
application mentioned in section 1.4
shall be submitted.
1.5.2 • Strength / concentration of drug of Submitted.
Active Pharmaceutical ingredient
(API) per unit. Strength of Active
ingredient shall be stated clearly. In
case API is in the form of salt, specify
the equivalent strength of the base
e.g., AAA sodium 50 mg (equivalent
to AAA) etc.
1.5.10 • You have mentioned the dosage Applied product is Injection dosage
form of applied drug as both injection form.
and oral while the reference product
is not available in applied strength in
oral dosage form, clarify?
3.2.S.4.1- • Copies of the Drug substance • Submitted
3.2.S.4.3 specifications and analytical
substance manufacturer is required.
Product manufacturer for drug
substance(s) shall be submitted.
3.2.P.2.2.1 • Pharmaceutical equivalence of the • The iohexol 50 ml and iohexol 100 ml, the
applied drug with reference product two specifications have the same
in 100ml volume is submitted, while concentrations, only the filling quantity is
the volume of applied product is different.
50ml, clarify?
3.2.P.7 • The innovator product is packed in • Various types of glass used for
+PLUSPAK™ (polymer bottle) pharmaceutical packaging as per USP
while you have packed the product in Type I - borosilicate glass our
medium borosilicate glass infusion manufacturer packaging is up to mark with
bottles, halogenated butyl rubber USP specification. Study results for the test
stopper (chlorinated) for injections, of leachable have been submitted.
and aluminum plastic combined caps
for infusion bottles clarify?

3.2.P.8 • The real time stability study data of • Firm has submitted data stability reports of
Finished Pharmaceutical Product of 2 accelerated (6months) & long term (36
batches (190907 and 190908) is for months) stability studies as per Zone-IV a
18 months only while the stability condition of three new batches i.e.,
rd
study data for 3 batch (190909) is 1506038, 1511019 & T1712008
for 36 months. Submit complete real manufactured in 23-06-2015, 04-11-2015
time stability data till shelf life as per & 04-12-2017 respectively.
zone IV-A
• Moreover, it must be justified that
the stability data of 36 months could
be performed for batch# R190909
which was manufactured on 11-09-
2019 for which 36 months has not
been passed yet.
Decision: Approved as per Policy for inspection of Manufacturer abroad and verification of local
storage facility.
115. Name, address of Applicant / Importer M/s Graton Pharma., Suit No.501 and 502 fifth
floor plot No. 42C/2lane 8 bukhari commercial
DHA phase 6, Karachi-75500, Pakistan.
Address: Office No.501 and 502 fifth floor plot
No. 42C/2lane 8 Bukhari commercial DHA phase
6, Karachi-75500, Pakistan.
Address of Godown: --
Validity: 21-10-2023.
Status: License to sell, stock and exhibit for sale,
distribute and sell drugs by way of whole sale.
Name and address of marketing Beijing Beilu Pharmaceutical Co., Ltd. No. 3
authorization holder (abroad) Shuiyuan West Road, Miyun District, Beijing
China
Name, address of manufacturer(s) Beijing Beilu Pharmaceutical Co., Ltd. No. 3
Shuiyuan West Road, Miyun District, Beijing
China
Detail of certificates attached (CoPP, Free CoPP: Firm has submitted copy of legalized CoPP
sale certificate, GMP certificate) certificate (No. Beijing20210128) issued by
Beijing Municipal Medical Products
Administration No. 70 Zaolinqian Street,
Xicheng District Bejing for Iohexol 100ml: 35g (I)
Injection. The CoPP confirms free sale status of
the product in exporting country as well as GMP
status of the manufacturing site through periodic
inspections.
Details of letter of authorization / sole Firm has submitted copy of product specific
agency agreement authority letter from Beijing Beilu Pharmaceutical
Co., Ltd. Address 7th Floor, Block Maples
International office, No. 32 Xizhimen North
Street, Haidian District, Beijing City, PR. China in
the name of M/s Graton Pharma., Suit No.501 and
502 fifth floor plot No. 42C/2lane 8 bukhari

commercial DHA phase 6, Karachi-75500,
Pakistan. for following products
Iohexol Injection 50ml:17.5g(I)
This letter of appointment is valid upto 30-04-2026

unless revoked earlier.
☒ Importer
☐ Export sale
purpose only
Dy. No. and date of submission Dy. No. 809, Date of submission: 13-05-2022
Details of fee submitted PKR 75,000/- vide Deposit Slip No:1467185241
The proposed proprietary name / brand MONOPAQUE 100ml injection (Iohexol
name Injection (100ml: 35g (I))
Strength / concentration of drug of Active Each ml contains 755 mg of Iohexol equivalent to
Pharmaceutical ingredient (API) per unit 350mg of Iodine.
Pharmaceutical form of applied drug Injection
Pharmacotherapeutic Group of (API) Medical Imaging drug
specifications
The status in reference regulatory OMNIPAQUE 350 mg iodine/ml (755 mg of
authorities iohexol/mL), (100ml=35g I), Solution for injection
USFDA Approved by M/s Healthcare United
States
For generic drugs (me-too status) IOBRIX-350 INJECTION 100ml by M/s
Hoffmann Human Health Pak Ltd (Reg#032138)

product.
Name, address of drug substance Zhejiang Starry Pharmaceutical Co., Ltd., No. 1
manufacturer Sitaili, Modern Industrial Cluster Area, Xianju
County Zhejiang Province, China
Zhejiang Hichi Pharmaceutical Co., Ltd., Binhai
Road, Damaiyu Economic Development Zone,
Yuhuan County, Zhejiang China
process and controls of material, control of critical
steps and intermediates, impurities, specifications,
Stability Studies of Drug Substance Stability study conditions of Drug substance by
(Conditions & duration of Stability Zhejiang Hichi Pharmaceutical Co., Ltd:
studies) Real time: 30°C ± 2°C / 65% ± 5%RH for 36
months
months
(Batches: C0042010003, C0042011001,
C0042011002)
Stability study conditions of Drug substance by

Zhejiang Starry Pharmaceutical Co., Ltd:
months
months
(Batches: R190904, R190905, R190906)
characterization of impurities, justification of
Pharmaceutical Equivalence and Pharmaceutical equivalence of applied product
Comparative Dissolution Profile manufactured from both API sources performed
against reference product having strength
100ml:35g Iohexol injection
of product studies for the test of related substances in the
applied product since titration method is applied
for Assay test.

Container closure system of the drug Medium borosilicate glass infusion bottles,
product halogenated butyl rubber stopper (chlorinated) for
injections, and aluminum plastic combined caps
for infusion bottles
life and storage conditions batches. The accelerated stability study data is
conducted at 30oC ±2oC / 65% ± 5% RH.
Batches manufactured from API of Zhejiang
Haichang Pharmaceutical Co., Ltd
Batch No. Mfg. Date

R190907 10-09-2019
R190908 10-09-2019
R190909 11-09-2019
Batches manufactured from API of Zhejiang

Stellite Pharmaceutical Co., Ltd
Batch No. Mfg. Date
R190904 08-09-2019
R190905 09-09-2019
R190906 09-09-2019
Remarks of Evaluator XI:
Section Observations Response

1.1 • The applied drug product is a • Firm has submitted differential
generic drug product and you have fee of Rs. 75,000/- vide deposit
submitted fee 75000/- only. Submit slip# 0827443559
differential fee for the applied
product
• Address of the Product license • Firm has submitted declaration
holder/exporter on authority letter that our manufacturing License
and CoPP are different from each address is now described as “No.3
other. Clarification is required. Shuiyuan West Road, Miyun
District, Beijing”, which refers to
the same place that described in
the address written in the GMP
certificate which is “Miyun
Industrial Development Area,
Beijing”.
1.4.1 • All the information related to type Submitted
of application mentioned in section
1.4 shall be submitted.
1.5.10 • You have mentioned the dosage Dosage form is injection
form of applied drug as both
injection and oral while the
reference product is not available in
applied strength in oral dosage form,
clarify?

3.2.S.4.1- • Copies of the Drug substance • Submitted
3.2.S.4.3 specifications and analytical
procedures used for routine testing
of the Drug substance /Active
substance manufacturer is required.
Product manufacturer for drug
substance(s) shall be submitted.
3.2.P.7 • The innovator product is packed in • Various types of glass used for
+PLUSPAK™ (polymer bottle) pharmaceutical packaging as per
while you have packed the product USP Type I - borosilicate glass
in medium borosilicate glass our manufacturer packaging is up
infusion bottles, halogenated butyl to mark with USP specification.
rubber stopper (chlorinated) for Study results for the test of
injections, and aluminum plastic leachable have been submitted.
combined caps for infusion bottles
clarify?
3.2.P.8 • The submitted long term stability Firm has submitted revised data for
data of Finished Pharmaceutical stability summary, wherein
Product manufactured from API manufacturing dates of previously
source of Zhejiang Haichang submitted stability batches has been
Pharmaceutical Co., Ltd is of corrected as 09-2018 along with
different duration for various submission of stability reports of
batches briefed below. accelerated (6months) & long term
Batch# R190907, …. 6 Months (36 months) stability studies as per
Batch# R190908…..18 Months Zone-IV a condition.
Batch#R190909……36 Months
Clarification is required.
• Moreover, it must be justified that
the stability data of 36 months could
be performed for batch# R190909
which was manufactured on 11-09-
2019 for which 36 months has not
been passed yet.
• The long-term stability data of

Finished Pharmaceutical Product
manufactured from API source of
Zhejiang Stellite Pharmaceutical
Co., Ltd has been submitted upto 6
months only. Details of batches:
R190904……6 months
Decision: Approved as per Policy for inspection of Manufacturer abroad and verification of local
storage facility.
b. Routine applications of Import submitted on Form 5F

116. Name, address of Applicant / Importer M/s Seatle Private Limited, 45-KM Multan
Road, Lahore.
Details of Drug Sale License of importer License No: 05-351-0073-029396P
Address: Seatle Private Limited, 45-KM
Multan Road, Lahore.
Address of Godown: NA
Validity: 19-03-2022 (Renewal applied)
Status: License to sell drugs in a Pharmacy
Renewal: yes
Name and address of marketing authorization LDP-LABORATORIOS TORLAN, S.A.
holder (abroad) Ctra. de Barcelona, 135-B 08290 Cerdanyola
del Valles Barcelona - Spain.
Name, address of manufacturer(s) Drug product manufacturer: LDP-
LABORATORIOS TORLAN, S.A.
Ctra. de Barcelona, 135-B 08290 Cerdanyola
del Valles Barcelona – Spain.
Water for injection 10ml:

Haut Pharma Livron SAS, 1 rue Comte de
sinard, 26250, Livron sur Drome. France
Name of exporting country Spain
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized
Freesale certificate, GMP certificate) copy of CoPP certificate (No. 2020/01561)
dated 20/06/2020 issued by Spanish Agency for
Medicines and Health Products, Spain for
Fratazid 1g powder and 10ml solvent for
solution for injection (IV). The CoPP confirms
free sale status of the product in exporting
country as well as GMP status of the
every 3 years.
Submitted COPP does not reflect any detail

regarding manufacturer of the accompanying
diluent i.e., 10ml WFI.
GMP:
Firm has submitted Legalized “Manufacturing
authorization certificate no. 2279E” dated 26-
11-2018, issued to LDP-LABORATORIOS
TORLAN, S.A. Ctra. de Barcelona, 135-B
08290 Cerdanyola del Valles Barcelona –
Spain., wherein manufacturing facility for
sterile products of B-lactam antibiotics” is
confirmed.

authorization certificate no. M 19/112” dated
13-06-2019, issued to Haut Pharma Livron SAS,
1 rue Comte de sinard, 26250, Livron sur
Drome. France, wherein manufacturing facility
for sterile products of Small Volume Parenteral”
is confirmed.

Copy of GMP certificate no.
NCF/2024/001/CAT hs also been submitted for
LDP-LABORATORIOS TORLAN, S.A. Ctra.
de Barcelona, 135-B 08290 Cerdanyola del
Valles Barcelona – Spain valid upto 20-06-
2020.
Copy of Eudra GMP certificate no.
2020/HPF/FR/081 for Haut Pharma Livron
SAS, 1 rue Comte de sinard, 26250, Livron sur
Drome. France, valid upto 13-02-2023.
Details of letter of authorization / sole Firm has submitted original legalized sole
agency agreement agency agreement. The agreement specifies that
the manufacturer appoints M/s Seatle Private
Ltd. to register their products in Pakistan as sole
importer.
A manufacturing agreement has also been

submitted wherein M/s LDP-
LABORATORIOS TORLAN, S.A. has
declared Haut Pharma Livron SAS, 1 rue Comte
de sinard, 26250, Livron sur Drome. France as
manufacturer of the diluents i.e., Lidocaine HCl
1% ampoule & WFI ampoules for Ceftriaxone
formulations to be imported by M/s Seatle.
☒ Importer
giver)
☐ Export sale
For imported products, specify one the these ☒ Finished Pharmaceutical product import
purpose only
Details of fee submitted For Ceftriaxone:
PKR 100,000/-: 18-8-2020
For WFI:
PKR 100,000/-: 15-06-2020
The proposed proprietary name / brand name FRATAZID INJECTION 1g IV
Strength / concentration of drug of Active Each vial of powder contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone (as Sodium) ……... 1g
Each Ampoule contains:

Sterile Water for Injection ………10ml

Pharmaceutical form of applied drug Powder and solvent for solution for Injection
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotic
Reference to Finished product specifications Drug product: USP
Diluent WFI: European Pharmacopoeia
Proposed unit price As per DPC
The status in reference regulatory authorities Rocephin Injection 1g (USFDA Approved).
For generic drugs (me-too status) Oxidil of SAMI Pharma Pvt. Ltd. (Reg #
022422)
Name, address of drug substance Qilu Antibiotics Pharmaceutical Co., Ltd.
manufacturer No. 849 Dongjia Town, Licheng District, Jinan,
Shandong Province, China.
substance.
(Conditions & duration of Stability studies) batches of API at accelerated as well as real time
conditions. The real time stability data is
conducted at 25oC ± 2oC and 60% RH The
stability study data is till 36 months.
and stability.
Pharmaceutical Equivalence and Pharmaceutical equivalence studies have been
Comparative Dissolution Profile submitted against the Rocephin 1gm Injection.

Analytical method validation/verification of Firm has submitted analytical method validation
product studies for the applied product.
Container closure system of the drug product Type II glass vial for Powder
Type I glass ampoule for WFI
Stability study data of drug product, shelf life Drug product:
and storage conditions Firm has submitted stability study data of 3
batches of drug powder vial. The accelerated
stability study data is conducted at 40oC ±2oC /
75% ± 5% RH for 6 months. The real time
65% ± 5% RH. The real time stability study data
of all 3 batches is completed till 36 months.
Diluent WFI: Firm has submitted stability
study data of 3 batches of 10ml WFI. The
accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The
real time stability study data is conducted at
30oC ±2oC / 65% ± 5% RH. The real time
stability study data of all 3 batches is completed
till 60 months.
117. Name, address of Applicant / Importer M/s Seatle Private Limited, 45-KM, Multan
Road, Lahore.
Address: Seatle Private Limited, 45-KM,
Validity: 19-03-2022 (Renewal applied)
Renewal: Sale License is Valid
Name and address of marketing authorization LDP-LABORATORIOS TORLAN S.A.
Lidocaine HCl 1%w/v:

every 3 years.

diluent i.e., Lidocaine HCl 1% injection.
GMP:
confirmed.

is confirmed.

2020.
Details of letter of authorization / sole Firm has submitted original sole agency
agency agreement agreement. The agreement specifies that the
manufacturer appoints M/s Seatle Private Ltd. to
register their products in Pakistan as sole
importer.
☒ Importer
giver)
☐ Export sale
purpose only

PKR 100,000/-: 18-8-2020
For WFI:
PKR 100,000/-: 15-06-2020
The proposed proprietary name / brand name FRATAZID INJECTION 500g IM
Pharmaceutical ingredient (API) per unit Ceftriaxone (as Sodium) ……... 500mg
Each 2ml Ampoule contains:

Sterile Lidocaine HCl ………20mg
(Ph. Eur specification)
Reference to Finished product specifications Drug product: USP
Diluent Lidocaine HCl injection 2%w/v:
European Pharmacopoeia
The status in reference regulatory authorities Rocephin Injection 500mg (USFDA Approved).
022422)
Name, address of drug substance Ceftriaxone: Qilu Antibiotics Pharmaceutical
manufacturer Co., Ltd.
No. 849 Dongjia Town, Licheng District, Jinan,
Lidocaine: Haupt Pharma Livron, 1 rue Comte
de Sinard, Livron Sur Drome, 26250, France.
substance.

conducted at 25oC ± 2oC and 60% RH the
and stability.
Pharmaceutical Equivalence and Pharmaceutical Equivalence study has been
Comparative Dissolution Profile submitted against Rocephin Injection 500mg.
Type I glass ampoule for Lidocaine
Stability study data of drug product, shelf life Drug product:
and storage conditions Firm has submitted stability study data of 3
batches of drug powder vial. The accelerated
75% ± 5% RH for 6 months. The real time
65% ± 5% RH. The real time stability study data
of all 3 batches is completed till 36 months.
Diluent Lidocaine HCl 1%: Firm has
submitted stability study data of 3 batches. The
accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The
till 60 months.
118. Name, address of Applicant / Importer M/s Seatle Private Limited, 45-KM, Multan
Road, Lahore.
Address: Seatle Private Limited, 45-KM,
Validity: 19-03-2022 (renewal applied)
Renewal: Sale License is Valid
Name and address of marketing authorization LDP-LABORATORIOS TORLAN, S.A.

Water for injection 5ml:
every 3 years.
diluent i.e., 10ml WFI.
GMP:
confirmed.
is confirmed.

2020.
Details of letter of authorization / sole Firm has submitted original legalized sole
agency agreement agency agreement. The agreement specifies that
the manufacturer appoints M/s Seatle Private
Ltd. to register their products in Pakistan as sole
importer.
A manufacturing agreement has also been
submitted wherein M/s LDP-
LABORATORIOS TORLAN, S.A. has

declared Haut Pharma Livron SAS, 1 rue Comte
de sinard, 26250, Livron sur Drome. France as
manufacturer of the diluents i.e., Lidocaine HCl
1% ampoule & WFI ampoules for Ceftriaxone
formulations to be imported by M/s Seatle.
☒ Importer
giver)
☐ Export sale
purpose only
PKR 100,000/-: 18-8-2020
For WFI:
PKR 100,000/-: 15-06-2020
The proposed proprietary name / brand name Fratazid 500mg IV Injection
Pharmaceutical ingredient (API) per unit Ceftriaxone (as Sodium) ……... 500mg
Each Ampoule contains:
Sterile Water for Injection ………5ml
Reference to Finished product specifications European Pharmacopoeia
The status in reference regulatory authorities Rocephin Injection 500mg (USFDA Approved).
022422)

Name, address of drug substance Qilu Antibiotics Pharmaceutical Co., Ltd.
manufacturer No. 849 Dongjia Town, Licheng District, Jinan,
substance.
conducted at 25oC ± 2oC and 60% RH The
and stability.
Pharmaceutical Equivalence and Pharmaceutical Equivalence study has been
Comparative Dissolution Profile submitted against Rocephin Injection 500mg IV
Type I glass ampoule for WFI
Stability study data of drug product, shelf life Firm has submitted stability study data of 3
and storage conditions batches of drug powder vial and WFI ampoule.
The accelerated stability study data is conducted
at 40oC ±2oC / 75% ± 5% RH for 6 months. The
till 36 months.
Evaluation by PEC:

1.3.4 Copy of valid Drug Sale License Firm has submitted copy of DSL
(DSL) issued by relevant licensing valid till 19-03-2022 along with
authority shall be submitted. receipt of renewal application.
Sole agency agreement / letter of Copy of sole agency agreement from
authorization between applicant and M/s LDP-Laboratorios TORLAN,

marketing authorization holder shall S.A., Ctra Barcelona, Spain in the
be submitted. name of M.s Seatle Provate Ltd.,
Lahore, Pakistan has been submitted.
1.5.6 The said section declares Firm has revise specifications to
Pharmacopoeial reference as USP , without submission of fee.
European Pharmacopoeia
specifications, monograph of applied
product is not available in European
Pharmacopoeia.
2.3 Table for literature references for the Submitted.
drug substance & drug product has
not been submitted.
2.3.P.5.1 Assay limits are not as per the Revised Specification and
Pharmacopoeial monograph. Analytical Procedure as per USP is
submitted
2.3.R.1.1 Submitted BMR declare the Firm has submitted revised BMRs.
calculation of drug substance fill
weight per vial on the basis of “Assay
of anhydrous active substance”
instead of “Assay of as is active
substance”
3.2.S.4.2 • Copy of drug substance • Revised Specification and
specifications and analytical Analytical Procedure applied by
procedure applied by Drug Drug Product Manufacturer as
product manufacturer shall be per USP is submitted
submitted.
• The USP monograph of
Ceftriaxone sodium, recommends
the potency of Ceftriaxone in
USP Ceftriaxone Sodium RS
(μg/mg) for the calculation of
Assay, whereas submitted drug
substance analytical procedure
applies the potency of
Ceftriaxone sodium in %age.
3.2.S.4.3 • Analytical Method Verification • AMV report is submitted form
studies including specificity, Drug product manufacturer.
(method precision) performed by
the Drug Product manufacturer
shall be submitted.
3.2.S.4.4 • The specifications for Assay test • Revised COA, according to USP
mentioned in the batch analysis monograph and section 3.2.S.4.1
certificate from drug product from Drug Product Manufacturer
manufacturer are different from is submitted
that submitted in section
3.2.S.4.1.
• The drug substance COA from
the M/s Qilu Pharma is as per
USP monograph whereas COA
from M/s LDP Laboratories
Torlan S.A. is as per the BP
monograph. Justification shall be

• A brief information on the • Submitted.
3.2.P.2 pharmaceutical development • Compatibility study has been
shall be included. This submitted for 1gm injection only
information specifies the with water for injection.
justification of formulation and
method of manufacturing. It is
also important that critical quality
attributes (CQAs) and Critical
Process Parameters (CPP) shall
be discussed.
• Compatibility studies for the
applied product shall be
performed as per the instructions
provided in individual label of the
drug product.
3.2. • Submitted drug product • Revised Specifications
P.5.1 specifications does not include according to USP including the
Assay limit for the content of dry test for crystallinity, are
powder injection i.e., an amount submitted.
of Ceftriaxone Sodium equivalent
to NLT 776 μg/mg of ceftriaxone
• Test of crystallinity ha sot been
included the drug product
specifications.
3.2.P.5.2 • Sample preparation procedure • Firm has submitted revised
mentioned in analytical method, analytical procedure as per USP
does not include sample monograph
preparation for “Sample solution
2”, as defined in the USP
monograph of “Ceftriaxone for
injection.”
3.2.P.5.4 • Submitted COAs of drug product • Firm has submitted COA of
does not include Assay test for recent batch of the drug product
sample solution 2 as manufactured in May, 2022
recommended by USP wherein Assay analysis has been
monograph of “Ceftriaxone for performed as per USP
injection”. monograph.
3.2.P.6 • COA of primary / secondary • Submitted.
reference standard including
provided.
3.2.P.8 • Submitted stability data does not • Please note that the Sample
reflect the performance of Assay Preparation Method mentioned
test for sample solution 2 as in Analytical Method does not
recommended by USP include sample preparation for
monograph of “Ceftriaxone for “Sample Solution 2” and only
injection”. the preparation of Sample
• Data of stability batches shall be Solution 1”is included.
supported by respective However, we will include both
documents like chromatograms, the preparation of Sample
Raw data sheets, COA, summary Solution 1 and Sample Solution
data sheets etc. 2 by revising the specifications
and analytical procedures

according to the USP
Monograph.
• Submitted.
Decision: Registration Board deferred the applications of FRATAZID INJECTION 1g IV &

FRATAZID INJECTION 500g IM for submission of CoPP with details of the composition and
manufacturer of accompanying diluent.
119. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt) Ltd.
793-D, Block ‘’C’’, Faisal Town Lahore.
Details of Drug Sale License of importer License No: 05-352-0065-016174-D
Address: 793-D, Block -C, Faisal Town Lahore
Name and address of marketing M/s Beacon Pharmaceuticals Limited
authorization holder (abroad) Plant address: Kathali Bhaluka Mymensingh
Bangladesh
Office Address: 9/A Toyenbee Circular Road
Motijheel Dhaka Bangladesh
Name, address of manufacturer(s) M/s Beacon Pharmaceuticals Limited
Plant address: Kathali Bhaluka Mymensingh
Bangladesh
Office Address: 9/A Toyenbee Circular Road
Motijheel Dhaka Bangladesh
Name of exporting country Bangladesh
Firm has submitted original legalized COPP (DA/6-110/2016/3292) issued on
01-June-2020 Government of the people‘s republic of Bangladesh, Ministry of Health & Family
welfare, Directorate General of Drug Administration Oushad Bhaban, Mohkhali Dhaka-1212,
Bangladesh.
GMP: Firm has submitted Legalized GMP certificate (Certificate No. DA/6-110/06/10002)
issued by M/s Beacon Pharmaceuticals limited. Also Renewal certificate is submitted.
• Firm has submitted copy of letter of distribution certificate from Beacon Pharmaceuticals
limited. The letter specifies that the manufacturer appoints M/s Himmel Pharmaceuticals Pvt.
Ltd. to register their products in Pakistan. The authorization letter is valid till June, 2025.
☒ Importer
☐ Export sale

purpose only
The proposed proprietary name / brand Hernix 40mg tablet
name
Pharmaceutical ingredient (API) per unit Neratinib Maleate equivalent to Neratinib ……….
40mg

specifications
Proposed Pack size 180’s in HDPE bottle
Proposed unit price As per current pricing policy of DRAP
The status in reference regulatory Nerlynx 40mg (Pierre Fabre Medicament , France)
authorities
stability studies of drug substance..
Name, address of drug substance Beijing Mesochem Technology Co., Ltd.
manufacturer Floor 23, Building 9, Lippo Plaza
Economic and Technological Development Zone
Beijing
substance.
(Conditions & duration of Stability API at accelerated as well as real time conditions. The
studies) real time stability data is conducted at 25±2ºC,
60%±5%RH. The stability study data is till 24 months.

Pharmaceutical Equivalence and Comparative analysis Studies against the reference
Comparative Dissolution Profile product Nerlynx 40mg (Pierre Fabre Medicament,
France) has been submitted
Container closure system of the drug HDPE Bottle
product
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches.
life and storage conditions Accelerated stability studies have been conducted at
40°C±2°C and 75%±5% RH for 6 months.
Real time stability studies conducted at 30°C±2°C and
65% ± 5% for 24 months.
Remarks of Evaluator :II
Section #. Deficiencies Firm’s response

3.2.S.4 • Copies of the Drug substance • Drug product manufacturer
specifications and analytical has submitted, specifications,
procedures used for routine testing analytical procedure,
of the Drug substance /Active analytical method verification
Pharmaceutical Ingredient by Drug studies & COAs for drug
Product manufacturer is required. substance.
submitted.
• Provide results of analysis of
studiesjasm, along with Certificate
of Analysis (CoA) of the same
batch from Drug Substance /
manufacture
3.2.P.1 • Qualitative composition of applied • The excipients used complies
product is not same as that of the with current pharmacopoeial
innovator product. monographs. These excipients
are pharmaceutically inert
substance and we have used
these excipients below the IIG
limit of FDA database as well
as we have done extensive
analysis of the product afer

formulation and found
satisfactory result of assay,
dissolution results & impurity
profile. Also w have done
stability study during
developmeht stage and found
satisfactory result of the
product. So we can conclude
that these excipients are not
incompatible with the API.
3.2.P.2 Compatibility studies of the Drug • The excipients used complies
Substance(s) with excipients shall be with current pharmacopoeial
submitted, since the qualitative monographs. These
composition of the formulation is not excipients are
similar to innovator / reference product. pharmaceutically inert
these excipients below the
IIG limit of FDA database as
well as we have done
extensive analysis of the
product afer formulation and
found satisfactory result of
assay, dissolution results &
impurity profile. Also w have
done stability study during
3.2.P.5.1 • US FDA review document of the • The dissolution time for
Innovator product i.e., Nerlynx, hernix tablet ha sbeen slected
specifies the dissolution limit as 45 minutes as perthe british
“NLT Q in 30 minutes”, whereas Pharmacopeoia guidline,
submitted specifications declare the reference chapter
dissolution limits as “NLT 75% in monographof the BP in the
45 minutes”. Justify the variation in dissolution tests for tablets &
time point of dissolution. capsules, Appendix XII B1. I
• Submitted specifications does not nthe reference chapter it I
include test of content uniformity smentioned that , “Unless
by way of Assay. otherwise indicated in th
emongraph, withdraw
samples at 45 minutes”.
Hence, we have selected 45
minutes as a sungle time
point.
3.2.P.5.4 • Test of content uniformity by way • Firm has submitted revised
of Assay has not been performed at finished product
the time of batch release. specifications including test
of content uniformity and
committed to provide COA
from next commercial batches
as per revised specifications.
3.2.P.8 • Following shall be submitted: • Submitted.

i. Analytical record for stability
studies including raw data
sheets, chromatograms etc.
ii. Complete batch manufacturing
record.

• Scientific jusytification for difference in dissolution limits in terms of %age released and time
point from that recommended by the US FDA for innovator product along with comparison
of disintegration & release profile of the applied product & innovator product.
120. Name, address of Applicant / Importer M/s Himmel Pharmaceuticals (Pvt) Ltd.
793-D, Block ‘’C’’, Faisal Town Lahore.
Details of Drug Sale License of importer License No: 05-352-0066-016174-D
Address: 793-D, Block-C, Faisal Town Lahore
Status: License to sell drugs as a distributor
Address of Godown: N/A
Name and address of marketing M/s BEACON Pharmaceuticals Limited
authorization holder (abroad) Plant address:Kathali ,Bhaluka,Mymensingh
Bangladesh
Office address: 9/B/2, Toynbee Circular RoaD,
Motijheel Dhaka, Bangaldesh
Name, address of manufacturer(s) M/s BEACON Pharmaceuticals Limited
Plant address:Kathali ,Bhaluka,Mymensingh
Bangladesh
Office address: 9/B/2, Toynbee Circular RoaD,
Motijheel Dhaka, Bangaldesh
Name of exporting country Bangladesh
Firm has submitted original legalized COPP (DA/6-110/2016/3296) issued on 01-June-2020
Government of the people‘s republic of Bangladesh, Ministry of Health & Family welfare,
Directorate General of Drug Administration Oushad Bhaban, Mohkhali Dhaka-1212, Bangladesh.
Firm has submitted Legalized GMP certificate (Certificate No. DA/6-110/06/10002) issued by
M/s Beacon Pharmaceuticals limited.

•
☒ Importer
☐ Export sale

purpose only
Dy. No. and date of submission Dy. No 2037746 Dated 03-03-2020
Details of fee submitted Rs.100,000/- Dated 03-03-2020
The proposed proprietary name / brand Niraparix 100mg
name
Strength / concentration of drug of Active Each capsule contains Niraparib Tosylate
Pharmaceutical ingredient (API) per unit Monohydrate INN equivalent to Niraparib 100mg
Pharmaceutical form of applied drug capsule

specifications
Proposed Pack size 90’s in HDPE bottle
Proposed unit price As per current pricing policy of DRAP
The status in reference regulatory Zejula 100mg Capsule (GlaxoSmithKline limited,
authorities Ireland)
Name, address of drug substance ANQING WORLD CHEMICAL COMPANY
manufacturer LIMITED No.21 Huancheng west road AnQing
County, AnHui Province China
Stability Studies of Drug Substance Firm has submitted long term stability study data of 3
(Conditions & duration of Stability batches of drug substance at 25°C ± 2°C / 60 ± 5% RH
studies) for 24 months. The accelerated stability data is
conducted at 40°C ± 2°C / 75 ± 5% RH for 6 months.
and process control, process validation report, control
of excipients, control of drug product, specifications,

Pharmaceutical Equivalence and Comparative analysis Studies against the reference
Comparative Dissolution Profile product of Zejula 100mg Capsule (GlaxoSmithKline
limited) has been submitted has been submitted.
Analytical method validation/verification Firm has submitted analytical method verification
of product studies of the drug product.
Container closure system of the drug White HDPE bottle
product
Stability study data of drug product, shelf Firm has submiited stability study data of 3 batches.
life and storage conditions Accelerated stability studies have been conducted at
40oC±2oC and 75%±5% RH for 6 months.
Real time stability studies conducted at 30oC±2oC and
65% ± 5% for 24 months
Remarks of Evaluator :II
Section #. Deficiencies Firm’s response

3.2.S.4 • Copies of the Drug substance Drug product manufacturer has
specifications and analytical submitted, specifications,
procedures used for routine testing analytical procedure, analytical
of the Drug substance /Active method verification studies &
Pharmaceutical Ingredient by Drug COAs for drug substance.
submitted.
• Provide results of analysis of
studiesjasm, along with Certificate
of Analysis (CoA) of the same
batch from Drug Substance /
manufacture
3.2.P.1 • Qualitative composition of applied • The excipients used complies
product is not same as per that of with current pharmacopoeial
the innovator product. monographs. These
excipients are
pharmaceutically inert
impurity profile. Also w have

done stability study during
3.2.P.2 Compatibility studies of the Drug • The excipients used
Substance(s) with excipients shall be complies with current
submitted, since the qualitative pharmacopoeial
composition of the formulation is not monographs. These
similar to innovator / reference excipients are
product. pharmaceutically inert
impurity profile. Also w
have done stability study
during developmeht stage
and found satisfactory result
of the product. So we can
conclude that these
excipients are not
3.2.P.2.2.1 • Pharmaceutical equivalence of the • Firm has referred to the Bio
applied drug shall be established equivalence studies of
with the innovator / reference / applied prodyuct performed
comparator product and results of as an open label, balanced,
all the quality tests (mentioned in randomized, two-treatment,
any official pharmacopoeia or two sequence, two-period,
section 3.2.P.5.1 of this crossover oral bioequivalence
application) of the developed study of single dose of
formulation and the innovator / Niraparix capsule against
reference / comparator product Zejula capsule of m/s tesaro
shall be submitted and discussed. UK ltd.
3.2.P.5.1 • US FDA review document of the • For dissolution method, we
Innovator product i.e., Zejula, have used US FD Adatabase
specifies the dissolution limit as for medium, apparatus,
“NLT Q in 45 minutes”, whereas volume and time point.
submitted specifications declare However, please note tha, for
the dissolution limits as “NLT 70% dissolution time point we
in 60 minutes”. Justify the variation slected as 60 minutes. Based
in time point of dissolution. n the US FDA databse,
dissolution tim endpoint
covered 60 minutes in
method of analysis.
3.2.P.8 • Accelerated stability studies of • Not replied against this point.
batch# 3830004, reflect significant • Analytical record for stability
change of in Assay results. data not submitted.
• Following shall be submitted: • BMRs have been submitted.

i. Analytical record for stability • Submitted GMP certificate
studies including raw data (No. NP122019) is not
sheets, chromatograms etc. verifiable form the NMPA
ii. Complete batch manufacturing web site.
record.
iii. GMP certificate of the drug
substance manufacturer issued
by the relevant regulatory
authority.

• Scientific jusytification for difference in dissolution limits in terms of %age released and time
point from that recommended by the US FDA for innovator product along with comparison
of disintegration & release profile of the applied product & innovator product.
121. Name, address of Applicant / Importer M/s 2 World Traders Pakistan. 55/2, Main
Khayaban-e-Hafiz, DHA, Karachi, Pakistan
importer Address: 55/2 Main Khayaban-e-Hafiz Phase-V,
DHA Karachi Pakistan
Status: Drug License by way of Whole Sale
Renewal: Valid
Name and address of marketing BIOMEDICA FOSCAMA Industria Chimico-
authorization holder (abroad) as per Farmaceutica, S.p.A. Via Morolense n.87, 03013
COPP Ferentino (FR) Italy.
Name, address of manufacturer(s) as per BIOMEDICA FOSCAMA Industria Chimico-
COPP Farmaceutica, S.p.A. Via Morolense n.87, 03013
Ferentino (FR) Italy.
Name of exporting country Italy
Detail of certificates attached (CoPP, CoPP: Firm has submitted original, legalized copy
Freesale certificate, GMP certificate) of CoPP certificate (NoCPP/2021/756) dated 02-04-
2021 issued by AIFA (Agenzia Italiana Del
Farmaco) for TAD (Glutathione 600mg. The CoPP
confirms free sale status of the product in exporting
country as well as GMP status of the manufacturing
site through periodic inspection.
GMP; Firm has submitted the legalized copy of
GMP certificate (No: IT/84/H/2020) which was
valid till 31-12-2021.
Details of letter of authorization / sole Firm has submitted attested copy of Import and
agency agreement Distribution Agreement between Biomedica
Foscama and 2 World Traders Pakistan for the
applied product.
☒ Importer

☐ Export sale
purpose only
Details of fee submitted PKR 75,000/-:Slip # 944857553239 10-08-2021
The proposed proprietary name / brand TAD 600mg dry powder injection
name
Pharmaceutical ingredient (API) per unit Glutathione as sodium ….…600mg
Pharmaceutical form of applied drug White lyophilized powder packed in moulded clear
type-3 vials along with 4ml solvent
Pharmacotherapeutic Group of (API) Antidote ATC Code: V03AB32
Reference to Finished product European Pharmacopoeia
specifications
Proposed Pack size 10 vials with 10 (4ml) solvent ampoules (WFI)
Proposed unit price As per pricing committee.
The status in reference regulatory TAD (AIFA Approved) complies EU

authorities Pharmacopoeia.
Name, address of drug substance M/s Biomedica Foscama Industria Chimico-
manufacturer Farmaceutica S.P.A (Italy)

(Conditions & duration of Stability of API for accelerated at 40oC ±2oC / 75% ± 5% RH
studies) for 6 months as well as Long term testing which is
conducted at 25oC ± 2oC / 65% ± 5% RH. The
stability study data is till 36 months at ≤ 25°C.
Module-III Drug Product: Firm has submitted data of drug product and solvent
(WFI) separately, including its description,
composition, pharmaceutical development,
Pharmaceutical Equivalence and Not applicable being the innovator product
Container closure system of the drug API: Type III glass vials with chlorobutyl stoppers
product Aluminium oversealed
Solvent: Type-I glass ampoules
Stability study data of drug product, shelf Firm has submitted stability study data of 3 batches.
life and storage conditions The accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The Long-
term stability study data is conducted at 25oC ±2oC /
65% ± 5% RH for 36 months.
Now the firm has submitted 18 months long term
stability studies data as per Zone IVb conditions,
detailed as under:
Batch# Initial date Duration
201007 07-2020 18 months
201008 07-2020 18 months
201009 07-2020 18 months
Firm has claimed 36 months shelf life on basis of

above submitted data.
Details of diluent: Composition: Water for injection
Container closure: 4ml Type I glass ampoule.
Manufacturer: BIOMEDICA FOSCAMA
Industria Chimico-Farmaceutica, S.p.A. Via
Morolense n.87, 03013 Ferentino (FR) Italy.
Stability data: Firm has submitted stability study
data of 3 batches. The accelerated stability study
data is conducted at 40oC ±2oC / 75% ± 5% RH for
6 months. The Long-term stability study data at
30oC ±2oC / 75% ± 5% RH has been submitted for 9
months only.

Evaluation by PECII:
Clinical profile of the applied product is as under:
• Therapeutic indications:
Prophylaxis of neuropathy following chemotherapy treatment with cisplatin or analogue.
• Pharmacotherapy category:
Antidotes, ATC code: V03AB32
• Dosage:
The generally recommended daily dose of TAD in patients receiving cisplatin or analogue chemotherapy
is 1.5 g / m2 (corresponding to 2.5 g) administered slowly intravenously.
• Contraindications:
Hypersensitivity to the active ingredient.
• Pharmaceutical description:
The drug substance is lyophilised in bulk form and then the bulk lyophilised powder is filled in glass
vials.

1.5.2 Strength per unit is mentioned as Glutathione Firm has corrected label claim
powder 600mg instead of Glutathione sodium. without submission of fee.
1.5.6 Pharmacopoeial reference for applied product is Firm has submitted statement
stated as European Pharmacopeia, whereas from M/s Biomedica
European monograph is not available for applied Foscama that the TAD
product. 600mg/4ml powder and
solvent for infusion state that
the product is contained in
packaging in compliance with
European Pharmacopoeia.
3.2.P.2.6 Compatibility studies shall be performed with Firm has submitted stability
the diluent specified in individual label of the study of 8hours after
drug product. reconstitutiton at 25+2oC.
Diluent
3.2.P.3.1 Details of the manufacturer of diluent shall be
submitted.
3.2.P.8.3 Long term stability studies data of diluent shall Firm has submitted long term
be submitted as per Zone Iva conditions till stability studies data of three
claimed shelf life i.e., 60 months. batches as per Zone IVa for
18 months.
Decision: Deferred for regulatory status of applied formulation in other reference regulatory
authorities alongwith its indications, precautions, contra indications etc.
122. Name, address of Applicant / Importer M/s Sitech Pharmaceuticals Pvt Ltd. SF 07 and 09, 4th
Floor Shahnaz Arcade 158- Main Shaheede Millat
Road, BYJCHS, Karachi, Pakistan
Address: Ground floor House No. 43-2B-1 Waja
Abdul Sattar Masti khan Road block-6 P.E.C.H.S
Karachi.
Address of Godown: SF 07 and 09, 4th Floor
Shahnaz Arcade 158- Main Shaheed e Millat
Road, BYJCHS, Karachi, Pakistan
Validity: 16 November 2023

Status: License to sell drugs by way of Wholesale.
Validity: 01-01-2022.
Name and address of marketing Derma Pharma S.A.R.L. 25, Rue la Boetie,
authorization holder (abroad) 75008 Paris – France
Name, address of manufacturer(s) Manufacturer:
Laboratorio Farmaceutico S.I.T S.r.l
Via Cavour 70, 27035 Mede (PV), Italy
Exporter:
Medexport Italia
Via Alcide De Gasperi 35, 00165 Rome (RM),
Italy
Name of exporting country Italy
Detail of certificates attached (CoPP, Free CoPP: Firm has submitted copy of legalized
sale certificate, GMP certificate) CoPP certificate (No. 036387) issued by Chamber
de Commerce et d Industrie de Region paris Iie-
de-France dated 06-August-2020.
The CoPP confirms free sale status of the product
in exporting country as well as GMP status of the
manufacturing site through periodic inspections.
Applicant of Certificate:
DB-Pharma -1 Bis, rue du Commandant Riviere-
94210 La Varenne Saint -Hilaire.
Details of letter of authorization / sole Letter of authorization issued by Laboratorio
agency agreement Farmeceutico SIT Specialita Igienico terapeutiche
S.r.l Italy in name of M/s Sitech pharmaceuticals
for the import of marketing of Dedrogyl
15mg/100mml oral soulton drops in Pakistan,
being exported from M/s Consorzio medexport
italia.
☒ Importer
☐ Export sale
purpose only
The proposed proprietary name / brand Dedrogyl 10 ml oral drops
name

Strength / concentration of drug of Active Each 100ml contains:
Pharmaceutical ingredient (API) per unit Calcifediol as monohydrate…15mg
Pharmaceutical form of applied drug Oral Drops Solution
Pharmacotherapeutic Group of (API) Vitamin D
Reference to Finished product specifications Eu. Ph. Current Edition
Proposed unit price As per Pricing Policy
The status in reference regulatory authorities Approved by ANSM of France
For generic drugs (me-too status) --
Module-II (Quality Overall Summary) Firm has submitted summarized information
Name, address of drug substance Carbogen Amcis B.V. Nieuweweg 2A,
manufacturer Veenendaal, 3901BE, Netherlands
Module-III Drug Substance: Firm has submitted Certificate of Suitability (R1-
CEP 1998-059 - Rev 08) issued by EDQM on 07-
01-2022.
analysis, characterization of impurities,
stability.
Pharmaceutical Equivalence and Not submitted
Container closure system of the drug product Amber glass-type III
and storage conditions batches. The accelerated stability study data is
months
Evaluation by PEC:
Initially the application was submitted from M/s Sitech Pharmaceuticals Pvt Ltd. dated 04-03-2021,
while subsequently M/s Angelini Pharmaceuticals (Pvt) Ltd. has submitted the new Form 5F of same
product to be imported from the same principal along with the documents detailed below:

Name, address of Applicant / Importer M/s Angelini Pharmaceuticals (Pvt) Ltd.
44 Commercial Imperial Block, Paragon City
Barki Road, Lahore, Pakistan
Details of Drug Sale License of importer License No: 05-352-0068-047191D
Address: 44 Commercial Imperial Block,

Paragon City, Barki Road, Lahore, Pakistan
Address of Godown: Same as above
Validity: 16 November 2023

Details of Letter of Withdrawal from Firm has submitted copy of letter from M/s
M/s Sitech Sitech Pharmaceutical Pvt. Ltd., dated 11-10-
2021 stating that “We SiTech
Pharmaceuticals (Pvt.) Ltd withdrew from our
application of registration of Dedrogyl 10ml
oral drops in favor of Angelini
Pharmaceuticals (Pvt} Ltd.”
Details of NOC from M/s Sitech Firm has submitted copy of letter from M/s
Sitech Pharmaceutical Pvt. Ltd., dated 06-05-
2021 stating that “We have submitted our
application for registration of drug Dedrogyl
10ml oral drops (Calcifediol l5mg/l00ml) to
DRAP Pharma Evaluation Cell on February
24, 2021.
Now the exporter and our principal M/s
Medexport Italia Rome, Italy has requested to
withdraw the application, and instead will be
resubmitted by their new distributor/importer
M/s. Angelini Pharmaceuticals (Pvt) Ltd.
having office at 44 Commercial Imperial
Block, Paragon City, Barki Road Lahore. This
decision is with our mutual understanding and
consent.
We have no objection for this and DRAP may
process the registration application of drug
Dedrogyl 10ml oral drops (Calcifediol
15mg/100ml) submitted by new distributor.
We would be grateful, if you please consider
& process application of above product
submitted by M/s. Angelini Pharmaceuticals
(Pvt) Ltd.”
Details of letter of authorization / sole Letter of authorization issued by Laboratorio
agency agreement from Exporter Farmeceutico SIT Specialita Igienico terapeutiche
S.r.l Italy in name of M/s Angelini
Pharmaceuticals (Pvt) Ltd. 44 Commercial
Imperial Block, Paragon City
Barki Road, Lahore, Pakistan for the import
of marketing of Dedrogyl 15mg/100mml oral

soulton drops in Pakistan, being exported
from M/s Medexport italia.
An authorization letter from M/s Med Export

Italia has also been submitted stating as under:
“We hereby confirm that our previous
authorization to M/s SiTech Pharmaceuticals
(Pvt) Ltd. located at SF - 07, 4th Floor,
Shahnaz Arcade 158, Shaheed-e-Millat Road,
BYJCHS, Karachi Pakistan is no longer valid
and now M/s Angelini Pharmaceuticals (Pvt}
Ltd. having office at 44 Commercial Imperial
Block, Paragon City, Barki Road, Lahore,
Pakistan is authorized to import, distribute,
market and also handle regulatory matters of
this product in the territory of Pakistan.”
The letter of authorizations has been issued form the drug product manufacturer i.e., Laboratorio
Farmaceutico S.I.T S.r.l Via Cavour 70, 27035 Mede (PV), Italy and Exporter i.e., M/s Medexport Italia
Via Alcide De Gasperi 35, 00165 Rome (RM), Italy while submitted COPP mentions Market
Authorization holder as Derma Pharma S.A.R.L. 25, Rue la Boetie, 75008 Paris – France.
Decision: Registration Board decided as follows:
a. Acceded the request of M/s Sitech Pharmaceutical Pvt. Ltd. for withdrawal of their submitted
application of Dedrogyl 10 ml oral drops dated 04-03-2021 vide Dy. No 7174 and declared it as
disposed off.
b. Deferred the application of M/s Angelini Pharmaceuticals (Pvt) Ltd. 44 Commercial Imperial
Block, Paragon City Barki Road, Lahore, Pakistan for submission of complete dossier of applied
product.
Case no. 05 Registration applications of drugs for which stability study data is submitted
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
123. M/s Wilshire Kanlif-M Tablet Form 5-D Invokamet approved by
Laboratories, 124/A, Each film coated Diary No. 19627 USFDA
Kotlakhpat, Indus: tablet contains: - dated 31-10-2017
Area, Township Canagliflozin Rs. 50,000/- dated
scheme, Lahore. …50mg 31-10-2017
Metforimn HCl …… 10’s,20’s,30’s50’s
500mg ; As per SRO
(Anti-diabetic)
Evaluation by PEC:
The firm has submitted stability data along with documents as per checklist approved in 278th
meeting of Registration Board.

Details of submitted data are as under:
(Dy.# 52 dated 01-01-2019)
Drug Kanlif-M Tablet 50/500
Name of Manufacturer M/s Wilshire Laboratories, 124/A, Kotlakhpat, Indus: Area,
Township scheme, Lahore
Manufacturer of API Canagliflozin hemihydrate: M/s Nantong Chanyoo Pharmatech
Co., Ltd., Jiangsu province, China
Metformin HCl: M/s Ipca laboratories Ltd., Aurangabad,
Maharashtra, India.
API Lot No. Canagliflozin hemihydrate: RD-CLF (hemihydrate)-201705051
Metformin HCl: 6417ML2RMI
Description of Pack
Alu-Alu foil
Frequency Accelerated: 0,1,2,3,4,6 months
Real Time: 0,3,6 months
No. of Batches 03
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
124. M/s Wilshire Kanlif-M Tablet Form 5-D Invokamet approved by
Laboratories, 124/A, Each film coated Diary No. USFDA
Kotlakhpat, Indus: tablet contains:- 19632dated 31-10-
Area, Township Canagliflozin 2017
scheme, Lahore. …50mg Rs. 50,000/- dated
Metforimn HCl…… 31-10-2017
1000mg 10’s,20’s,30’s50’s
(Anti-diabetic) ; As per SRO

Drug Kanlif-M Tablet 50/1000
Name of Manufacturer M/s Wilshire Laboratories, 124/A, Kotlakhpat, Indus: Area,
Township scheme, Lahore
Manufacturer of API Canagliflozin hemihydrate: M/s Nantong Chanyoo Pharmatech
Co., Ltd., Jiangsu province, China

Metformin HCl: M/s Ipca laboratories Ltd., Aurangabad,
Maharashtra, India.
API Lot No. Canagliflozin hemihydrate: RD-CLF (hemihydrate)-201705051
Description of Pack
Alu-Alu foil
Frequency Accelerated: 0,3,6 months
No. of Batches 03
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided following documents as per checklist approved by the Registration Board in its 293 rd
Meeting:
Sr.# Data requirement Firm’s submission

1. Reference of previous approval Firm has referred to onsite inspection report of their
of applications with stability product
study data of the firm. “Velbuvir 400/100mg Tablet”, which was presented in
292nd meeting of Registration Board.
Date of inspection: 23-05-2019
According to the report, following points were
confirmed:
a) Firm has HPLC software 21CFR compliant.
b) Audit teai lreports were available.
c) Firm’s stability chambers were calibrated and
equipped with digital data loggers and alarms.
2. Certificate of Analysis of API Submitted as per following details:
from both API Manufacturer and Canagliflozin hemihydrate: RD-CLF (hemihydrate)-
Finished Product manufacturer. 201705051
3. Method used for analysis of API Analytical method for both APIs have been submitted
along with COA. from relevant API manufacturers as well as from M/s
Wilshire Laboratories.
4. Stability study data of API from Canagliflozin hemihydrate:
API manufacturer Firm has submitted both accelerated (40°C ± 2°C & 75±
5%RH) stability studies & long term (30°C ± 2°C &
65%± 5%RH) stability studies reports of three batches.
Metformin HCl:

Firm has submitted both accelerated (40°C ± 2°C &
75±5%RH) stability studies (6 months) & long term
(30°C ± 2°C & 65%±5%RH) stability studies (60
months) reports of three batches.
5. Approval of API/ DML/GMP Canagliflozin hemihydrate: Manufacturing License
certificate of API manufacturer (No. Su 20160512) for M/s Nantong Chanyoo
issued by concerned regulatory Pharmatech Co., Ltd., No. 2 Tonghai Si road, Rudong
authority of country of origin. Coastal Economic Development Zone, Nantong, Jiangsu
Province, China issued by Jiangsu Food & Drug
Administration valid upto 2-12-2025.
Metformin HCl: Copy of GMP certificate (Certificate#.
NEW-WHO-GMP/CERT/AD/104179/2021/11/37725)
issued by FDA Maharshtra for M/s Ipca Laboratories
Ltd., H-4, MIDC, Waluj, Aurangabad, 431136,
Mahrashtra, India valid upto 27-10-2024.
6. Documents for the procurement • Canagliflozin hemihydrate: Copy of commercial
of API with approval from invoice (Invoice# CYI18153) dated 20-02-2017 has
DRAP (in case of import). been submitted. (Quantity: 6 Kg)
Copy of Goods declaration has also been submitted.
Metformin HCl: Copy of commercial invoice (Invoice#
21/1212016) attested by AD DRAP I&E dated
02/01/2017. (Quantity: 2000 Kg)
7. Authorized Protocols/SOP for Firm has submitted SOP for new product development &
the development & stability stability protocol.
testing of trial batches.
8. Method used for analysis of FPP Drug product analytical method has been submitted.
9. Drug-excipients compatibility Firm has referred to the formulation of innovator product
studies (where applicable) for establishing drug-excipient compatibility.
10. Complete batch manufacturing Firm has provided Batch Manufacturing Record for all
record of three stability batches. the three batches of both strengths.
11. Record of comparative Comparative dissolution studies have been submitted in
dissolution data (where three physiological buffers i.e., pH 1.2, pH 4.5 & pH 6.8
applicable) against the innovator product of Invoka Met, with
acceptable values of f2.
Trial Innovator product

Product
Name Kanlif-M Invoak met 50/500
50/500 tablet
tablet
Batch T-001 234751
#
Trial Innovator product

Product
Name Kanlif-M Invoak met 50/1000
50/1000 tablet
tablet
Batch T-001 264873
#

12. Data of 03 batches will be Firm has submitted analytical record for both accelerated
supported by attested respective & long-term stability studies, including chromatograms,
documents like chromatograms, raw data sheets etc..
data sheets etc.
13. Compliance Record of HPLC Audit trail reports have not been submitted instead a
software 21CFR & audit trail document titled “Declaration of Software Quality” from
reports on product testing. Agilent technologies has been submitted.
Sr.# Observation Firm’s response
1. Method of dilution preparation for Revised SOP for product development has
Assay test mentioned in “SOP for New been submitted as per the product test
Product Development” is different from method.
that mentioned in “Analytical Test
method for Kanlif-M 50/1000 tablets
(Document# WS-QC-TM-K-08)”.
2. Dissolution limits of time of innovator Firm has referred to the 293rd meeting of
are 20 minutes for metformin while registration Board while cuggestinig that the
applicant has proposed 30 minutes and appliedproduct falls in the category of
45 minutes for Canagliflozin instead of immediate relase drugs and now has revised
30 minutes. their specifications of dissolution as per
innovator’s literature.
3. Complete raw data sheets (including Submitted.
information of sample & standard
weights, dilution factors, calculation
formulas etc.) for the whole stability
studies shall be submitted.
5. GMP certificate for Metformin HCl has Copy of GMP certificate (Certificate#.
been submitted of M/s Ipca laboratories, NEW-WHO-
Madhya Paradesh, whreas API has been GMP/CERT/AD/104179/2021/11/37725)
imported form M.s IPCA Labs issued by FDA Maharshtra for M/s Ipca
Aurangabad. Laboratories Ltd., H-4, MIDC, Waluj,
Aurangabad, 431136, Mahrashtra, India
valid upto 27-10-2024.
7. Submitted batch manufacturing records Complet BMRs including details of
include dispensing sheets only. compression, coating & packaging have been
submitted for all three stability batches of
both strengths.
8. Audit trial reports have not been Digital Sytem activity log report has been
submitted instead a document titled submitted for the duration of stability studies.
“Declaration of Software Quality” from
Agilent technologies has been
submitted.
9. Digital data logger for temperature and Submitted.
humidity monitoring of stability
chambers has not been submitted
instead manual record of stability
chambers has been submitted for both
accelerated and long term conditions.

Decision: Registration Board approved Kanlif-M Tablet 50/500mg & Kanlif-M Tablet
50/1000mg with Innovator’s specifications.
• Manufacturer shall submit fee of Rs. 7500/- for each strength for correction/pre-
approval change in product specifications as per notification No.F.7-11/2012-
B&A/DRAP dated 07-05-2021.
• Furthermore, the Board diretced the firm to adopt dissolution specifications as per
innovator for commercial batches.
125. M/s Winlet Winzole Capsule 30mg Form-5 Dexilant capsule

Pharmaceuticals. Each Delayed Release capsule Dy.No 39627 dated delayed release
30-km, Lahore contains:- 03-12-2018 (30mg, 60mg).
Sargodha Road, Dexlansoprazole (as enteric Rs.20,000/- dated 03- USFDA
Lahore coated pellets) ….. 30mg 12-2018 approved.
126. M/s Winlet Winzole Capsule 60mg Form-5 Me-too could not
Pharmaceuticals. Each Delayed Release capsule Dy.No 39627 dated be confirmed.
30-km, Lahore contains:- 03-12-2018
Sargodha Road, Dexlansoprazole (as enteric Rs.20,000/- dated 03-
Lahore coated pellets) ….. 60mg 12-2018
Drug Winzole Capsule 30mg and 60mg
Name of Manufacturer M/s Winlet Pharmaceuticals. 30-km, Lahore Sargodha Road, Lahore
Manufacturer of API Dexlansoprazole 22.5% DDR pellets: M/s Vision Pharmaceuticals,
Islamabad
API Lot No. DLP519
Description of Pack
Alu-Alu blister
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Frequency Accelerated: 0, 2, 4, 6 (months)
Real Time: 0, 3, 6 (months)
For 30mg capsule
Batch No. 001 002 003
Batch Size 1500 1500 1500
Manufacturing Date 01.2020 01.2020 01.2020
No. of Batches 03
For 60mg capsule
Batch No. 001 002 003
Batch Size 1500 1500 1500

No. of Batches 03
Sr. Documents to Be Provided Status
No.
1. COA of API
Yes
2. Approval of API by regulatory authority of country Dexlansoprazole 22.5% DDR pellets: Copy
of origin or GMP certificate of API manufacturer of GMP certificate issued to M/s Vision
issued by regulatory authority of country of origin. Pharmaceuticals, Islamabad by DRAP,
valid till 10.02.2022.
3. Protocols followed for conduction of stability study
Yes
and details of tests.
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. NA
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.
On-site inspection Report
Name of Manufacturer M/s Winlet Pharmaceuticals.
Physical Address 30km Lahore Sargodha Road.
Drug Manufacturing License No. and 000874 by way of formulation

validity Valid till 20-02-2023.
Date of Inspection. 14-06-2021
Purpose of Inspection Verification of Authenticity of Stability

Data for Purpose of Registration of Drugs
with reference to DRAP’s letter No. F.1-
2/2020-PEC dated 16-03-2021 .
Name of Inspector 1. Mr. Muzammil Waheed.
(Director DTL, Faisalabad)
2. Ms. Maham Misbah
Assistant Director, DRAP, Lahore.
Name of firm Representatives 1. Mr. Khawaja Shahid Iqbal (CEO)
2. Ms. Misbah Khawaja (Director)
3. Dr. Qamar Soni (Director)
4. Mr. Gulfam Soni (Director)
5. Mr. Kaleem ullah (Production
Incharge)
6. Mr. Aslam Hayat (Quality Control
Manger)

Sr.
Question Observations
No
Whether the firm has Not Applicable. Firm had locally purchased Dexlansoprazole
1 documents confirming import 22. 5pc DDR pellets from M/s. Vision Pharmaceuticals. (Batch
of API? No. DLP519 Manufacturing date 09-19 Expiry date 08-22)
What was the rationale behind The rationale behind selecting the manufacturer was the cGMP
2 selecting the particular status of M/s Vision Pharmaceuticals, as informed by the
manufacturer of API? management of the firm.
Whether documents confirm
Not applicable. Firm had purchased secondary working
the import of API reference
3 standard of API and impurity standards from principal
standard and impurity
manufacturer.
standards?
Whether the firm has
certificate of Analysis of the
Firm had certificates of analysis for the API, working standard
4 API, reference standards and
and impurity standards.
impurity standards from
exporter?
Whether the firm has any
approval of API or GMP
certificate of API Firm had valid cGMP compliance certificate of M/s Vision
5
manufacturer issued by Pharmaceuticals issued by DRAP.
regulatory authority of country
of origin?
Whether firm use API
6 Yes.
manufacturer method of testing?
Whether firm has stability
7 Yes.
studies reports on API?
If yes, whether the stability
testing has been performed as
8 Degradation products had not been quantified.
per SIM method and degradation
products have been quantified?
Whether firm has method for
9 quantifying the impurities in the Yes, provided by the vendor.
API?
Whether firm has some
remaining quantities of the API,
10 Firm had remaining quantities of API.
its reference standard and
impurities standards?
Whether firm has used
No excipients used in the process. Firm is only filling the pellets
11 pharmaceutical grade
in capsules.
excipients?
Whether firm has documents
12 confirming the import of the Not applicable.
used excipients?
Whether firm has test reports
13 and other records on the Not applicable.
excipients used?
Whether firm has written and
Firm had written protocols for product development. However,
14 authorized protocols for the
the protocols required improvement.
development of capsules?

Whether firm has performed
15 Drug-excipient compatibility Not applicable.
studies?
Whether firm has performed Firm had not procured innovator’s product. Comparative
16 comparative dissolution dissolution studies had been performed against Razodex
studies? capsules (Getz Pharma)
Whether firm has product No. Capsules were filled with pellets using semi-automatic
17 development (R&D) section? capsule filling machine installed in the commercial production
area.
Whether firm has necessary
equipment available in product
18 development section for Firm was advised to obtain capsule polishing machine.
development of finished
product?
Equipment of commercial production was used. Installation and
Are the equipment in
Operational qualification had been done for the equipment, as
19 product development section
per documents shown to the panel. Performance qualification
qualified?
had not been done.
Whether firm has proper
maintenance / calibration / re-
20 qualification program for the Available for major equipment used in product development.
equipment used in PD
section?
Whether firm has qualified staff
in product development section
21 with proper knowledge and No. Separate staff for product development was not available.
training in product
development?
Whether firm has manufactured Firm had manufactured three stability batches each for the
three stability batches for the stability studies of finished products Dexlansoprazole 30mg and
22 stability studies of finished Dexlansoprazole 60mg.
product tablets as required? BMRs were shown to the panel. The firm was advised to
improve its BMRs.
What was the criteria for fixing As stated by the firm’s management, criteria for fixing batch
23 the batch size of stability size of stability batches was the available quantity of API and
batches? DRAP guidelines for stability testing.
Whether firm has complete
24 record of production of stability Firm had BMRs of all relevant stability batches.
batches?
Whether firm has protocols for
Yes. However, the conformance to protocols required
25 stability testing of stability
improvement.
batches?
Whether firm has developed and
Firm had used the testing method of vendor of pellets.
26 validated the method for testing
Validation report was shown to the panel.
of stability batches?
Whether firm has method
transfer studies in case when the
27 method of testing being used by No method transfer protocol was followed.
your firm is given by any other
lab?
Whether firm has documents Firm was advised to get testing equipment calibrated from
confirming the qualification of authorized body, without calibration the test results are not
28
equipments / instruments being acceptable. Further the firm was advised to attach printers with
all weighing balances, pH meter and conductivity meter for

used in the test and analysis of traceability and also advised to conduct daily verification of
API and the finished drug? weighing balances.
Whether firm has stability
29 No.
indicating method of analysis?
No. (amendments made in the data could not be detected
Whether firm has HPLC
30 without CFR 21 compliant software). Data used in the stability
software 21CFR compliant?
studies is highly unreliable
Whether firm could show you Yes, however, time and date could be changed in the HPLC
31
Audit Trail reports ? software.
Whether firm has some
remaining quantities of Firm had remaining quantities of stability batches. Degradation
32
degradation products and products had not been isolated.
stability batches?
Whether firm has commitment
33 batches kept on stability Yes.
testing?
Whether firm has valid Firm was advised to get testing equipment calibrated from
calibration status for the authorized body, further advised to attach printers with all
34
equipment used in production weighing balances, pH meter and conductivity meter and also
and analysis? advised to conduct daily verification of weighing balances.
Firm was advised to install proper alarm system in the stability
Do proper and continuous
chambers in order to monitor and control excursions.
35 monitoring and control are
Excursions were seen in the log of data of stability chambers
available for stability chamber?
(both real time and accelerated study chambers)
Do related manufacturing area, Management of the firm was given several advices related to
equipment, personnel and cGMP. It was advised to:
utilities be rated as GMP Maintain proper ledgers of packing materials, improve the
compliant? BMRs and make them more comprehensive, maintain record of
deviations, improve testing protocols and SOPs, develop and
maintain analyst logbooks for raw data, procure traceable
36
working and impurity standards, impart training of analysts,
develop a fully functional QA department, conduct complete
testing of primary packing materials, conduct supplier
evaluation of vendors of primary packaging materials, procure
traceable dead weights for verification of balances, use PDA
detector instead of SD-UVA detector.
Remarks:-
With reference to DRAP, Islamabad letter No. F.1-2/2020-PEC dated 16-03-2021 the
inspection of M/s Winlet Pharmaceuticals, 30km Lahore-Sargodha Road was conducted by the panel
with the remarks that authenticity of the stability data could not be verified without equipment
qualification, method transfer protocols and CFR compliant Software. Submitted for further necessary
action, please.
Decision of 316th meeting: Registration Board deferred the case for submission of clarification form
the firm upon following observations reported by Inspection panel:
• No method transfer protocol was followed for the drug product analytical method.
• Performance qualification had not been done for the manufacturing equipments used in trial
batch manufacturing.
• Firm was advised to get testing equipment calibrated from authorized body, without calibration
the test results are not acceptable.
• Amendments made in the data could not be detected without CFR 21 compliant software). Data
used in the stability studies is highly unreliable
• Authenticity of the stability data could not be verified without equipment qualification, method
transfer protocols and CFR compliant Software.

Firm’s response:
Observations Firm’s response
No method transfer protocol was followed We have already opted comparative
for the drug product analytical method. analytical testing method for studies of
Dexlansorpzole DDR Pellets provided by
Manufacturer (Vision Pharma), because
the same batch sample was tested in our
laboratory as previously tested in
manufacturer lab, and the test results of
both lab are comparable to satisfactory
level (Assay, dissolution & CDP etc).
Now we have documented this method
transfer studies protocol for commercial
scale production of Winzole 30mg & 6mg
capsules.
Performance qualification had not been The manufacturing equipments (i.e
done for the manufacturing equipments capsules filling machine, blister machine
used in trial batch manufacturing. which are used in trial batch manufacturing
are qualified) and the Performance
qualification is done and available for all
manufacturing equipments and updated it
for commercial scale production of
Winzole 30mg & 6mg capsules.
Firm was advised to get testing equipment All the major equipments are now
calibrated from authorized body, without calibrated from authorized bodies and the
calibration the test results are not standard using for calibration are National
acceptable. Institute of Standards and Technology
(NIST) traceable.
Amendments made in the data could not be The HPLC performance of the stability
detected without CFR 21 compliant studies was evident from the
software). Data used in the stability studies chromatographic record in the system and
is highly unreliable was also traceable from the respective
equipment log book. Now the HPLC
binary gradient system with 21 CFR
compliance software has also been
installed and now in working condition.
Authenticity of the stability data could not It is humbly submitted that the authenticity
be verified without equipment of the stability data is traceable through the
qualification, method transfer protocols available records in the HPLC system,
and CFR compliant Software. equipment utility log books, lab note books
& other records available at the plant.
For the stability studies data (submitted for
evaluation) of Winzole 30mg & 60mg
capsules, all the data, calculations, are
available with date in equipments/machine
log books , lab note books and the panel
inspection team had checked this data for
authenticity in detail.
It is also humbly submitted that we have
done the qualification of equipments and
the record is hereby submitted for ready
reference.

Decision of 320th meeting: Registration Board approved Winzole Capsule 30mg & Winzole
Capsule 60mg
with Innovator’s specifications.
• Manufacturer shall submit fee of Rs. 7500/- for each strength for correction/pre-approval
change in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
127. Name and address of M/s Pharmevo Private Limited., Plot # A-29, North
manufacturer / Applicant Western Industrial Zone, Port Qasim, Karachi
Brand Name +Dosage Form + IRMAX 100+5MG TABLET
Strength
Irbesartan….…100mg
Amlodipine ...5mg
Diary No. Date of R& I & fee Dy. No 1660 dated 29-Aug-2013, Rs.50,000/-
Pharmacological Group Antidiabetic
Type of Form Form-5D
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 7's, 10's, 14's, 20's, 28's, 30's & As per PRC
Approval status of product in AIMIX Approved by JAPAN
Reference Regulatory Authorities
Me-too status (with strength and Not Applicable
dosage form)
GMP status GMP inspection dated 23-02-2018 showed that the firm
was considered to be operating at an acceptable level of
compliance with GMP standards
Remarks of the Evaluator :
Previous decision:
The application was initially presented in 260th meeting of Registration Board wherein case was
deferred for proof of approval status of same formulation in reference countries and Pakistan.
Subsequently firm referred to the Aimix tablet approved by PMDA of Japan and submitted
stability studies data against which following observations were communicated to firm:
• Valid GMP certificate of M/s Prudence Pharma Chem., Gujarat, India shall be submitted.
• Content Uniformity test has not been performed for Amlodipine. Justification shall be
submitted.
• Justification/Clarification needed as in contrary to Japanese Pharmacopoeia monograph for
applied formulation firm has submitted different specifications and parameters for the Assay
& Dissolution test.
• Firm had submitted revised stability studies data along with documents as per exemption
checklist, detailed as below:
Drug IRMAX 100+5MG TABLET
Name of Manufacturer M/s Pharmevo Private Limited., Plot # A-29, North
Western Industrial Zone, Port Qasim, Karachi.
Manufacturer of API Irbesartan:
M/s Zhejiang Huahai Pharmaceutical Co. Ltd. Chuannan
Duqiao, Linhai, Zhejiang
Amlodipine:

M/s Prudence Pharma Chem, Plot No 7407, B/H, Lyka
Lab, GIDC. INDIA.
API Lot No. Irbesartan: C5055-20-13R
Amlodpine: AMB/194/10/20
Description of Pack
Alu-Alu Blister
Stability Storage Condition Real time : 30°C ± 2° C / 75% ± 5% RH
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated:0,1,2,3,4,6 (month)
Real Time: 0,3,6, (month)
Batch No. 21PD-3572-11-T 21PD-3575-12-T 21PD-3576-13-
T
Batch Size 2500 Tablet 2500 Tablet 2500 Tablet
No. of Batches 03
Documents To Be Provided Status
1 Reference of previous approval of Firm has referred to onsite inspection report of their
applications with stability study data product Erli Plus XR Tablet 5/1000mg, 10/1000mg,
of the firm 12.5/1000mg & 25/1000mg (Empagliflozin + Metformin
HCl XR) which was conducted on 05th December, 2019
and were presented in 293rd meeting of Registration Board
held on 6th -8th Jan, 2020.
According to the report following points were confirmed.
• Firm has 21 CFR compliant HPLC software.
• Firm has audit trail reports available.
• Firm possesses stability chambers with digital data
loggers.
2 Certificate of Analysis of API from Irbesartan:
both API Manufacturer and Finished M/s Zhejiang Huahai Pharmaceutical Co. Ltd. Chuannan
Product manufacturer. Duqiao, Linhai, Zhejiang.
API COA & FPP COA Provided
Amlodipine:
Lab, GIDC. INDIA.
3 Method used for analysis of API Submitted.
from both API Manufacturer and
Finished Product manufacturer
4 Stability study data of API from API Irbesartan- LPGA: The firm has submitted copy of
manufacturer accelerated, 06 Months (40°C ± 2°C & 75±5%RH) & long
term, 24 Months (30°C ± 2°C & 75±5%RH) stability
study reports of 03 batches
Amlodipine:
The firm has submitted copy of accelerated, 06 Months
(40°C ± 2°C & 75±5%RH) & long term, 24 Months (30°C
± 2°C & 65±5%RH) stability study reports of 03 batches
5 Approval of API/ DML/GMP Irbesartan: Copy of Drug manufacturing license (License
certificate of API manufacturer no. ZJ210061) issued by ZHEJIANG MEDICAL
issued by concerned regulatory PRODUCTS ADMINISTRATION submitted, valid up to
authority of country of origin. 09-May-2024.
Amlodipine:

Copy of Drug manufacturing license (License no. S-
GMP/20051984) for Food & Drug Administration Gujrat
Estate India, valid upto 18-05-2022
6 Documents for the procurement of Irbesartan: Copy of form 6, form 7 & Commercial Invoice
API with approval from DRAP (in from M/s Zhejiang Huahai Pharmaceutical Co. Ltd.
case of import). Chuannan Duqiao, Linhai, Zhejiang. is submitted attested
by AD(Karachi).
Amlodipine:
Copy of Commercial Invoice from M/s Prudence Pharma
Chem, Plot No 7407, B/H, Lyka Lab, GIDC. INDIA.is
submitted attested by AD (Karachi).
7 Protocols followed for conduction of Submitted.
stability study
8 Method used for analysis of FPP Submitted.
9 Drug-excipients compatibility Same excipients used as used by innovator.
studies (where applicable)
10 Complete batch manufacturing The firm has submitted copy of Trial batch manufacturing
record of three stability batches. record. Details are as under:
Batch no. Batch Size Mfg. Started
21PD-3572-11- 2500 03-2021
T
21PD-3572-11- 2500 03-2021
T
21PD-3572-11- 2500 03-2021
T
11 Record of comparative dissolution As per literature of the innovator available with the firm &
data (where applicable) as per Japanese Pharmacopeia.
The same has been demonstrated by the firm on their
product i.e. the product dissolve as per monograph.
Therefore, f2 calculations is not necessary.
12 Data of 03 batches will be supported Submitted.
chromatograms, Raw data sheets,
13 Compliance Record of HPLC Firm has submitted audit trail reports of stability studies
software 21CFR & audit trail reports of applied formulation.
on product testing.
128. Name and address of M/s Pharmevo Private Limited., Plot # A-29, North
manufacturer / Applicant Western Industrial Zone, Port Qasim, Karachi
Brand Name +Dosage Form + IRMAX 100+10mg TABLET
Strength
Irbesartan….…100mg
Amlodipine ...10mg
Diary No. Date of R& I & fee Dy. No 1656 dated 29-Aug-2013, Rs.50,000/-
Pack size & Demanded Price 7's, 10's, 14's, 20's, 28's, 30's & As per PRC

Approval status of product in AIMIX Approved by JAPAN
Me-too status (with strength and Not Applicable
dosage form)
GMP status GMP inspection dated 23-02-2018 showed that the firm
was considered to be operating at an acceptable level of
compliance with GMP standards
Remarks of the Evaluator:
Now the firm has submitted stability data detailed as under:
Drug IRMAX 100+10MG TABLET
Name of Manufacturer M/s Pharmevo Private Limited., Plot # A-29, North
Western Industrial Zone, Port Qasim, Karachi.
Manufacturer of API Irbesartan:
M/s Zhejiang Huahai Pharmaceutical Co. Ltd. Chuannan
Duqiao, Linhai, Zhejiang
Amlodipine:
Lab, GIDC. INDIA.
API Lot No. Irbesartan: C5055-20-13R
Amlodpine: AMB/194/10/20
Description of Pack
Alu-Alu Blister
Stability Storage Condition Real time : 30°C ± 2° C / 75% ± 5% RH
Frequency Accelerated:0,1,2,3,4,6 (month)
Real Time: 0,3,6, (month)
Batch No. 21PD-3573-13-T 21PD-3577-14-T 21PD-3578-15-
T
No. of Batches 03
Documents To Be Provided Status
1 Reference of previous approval of Firm has referred to onsite inspection report of their
applications with stability study data product Erli Plus XR Tablet 5/1000mg, 10/1000mg,
of the firm 12.5/1000mg & 25/1000mg (Empagliflozin + Metformin
HCl XR) which was conducted on 05th December, 2019
and were presented in 293rd meeting of Registration Board
held on 6th -8th Jan, 2020.
According to the report following points were confirmed.
• Firm has 21 CFR compliant HPLC software.
• Firm has audit trail reports available.
• Firm possesses stability chambers with digital data
loggers.
2 Certificate of Analysis of API from Irbesartan:
both API Manufacturer and Finished M/s Zhejiang Huahai Pharmaceutical Co. Ltd. Chuannan
Product manufacturer. Duqiao, Linhai, Zhejiang.
Amlodipine:
Lab, GIDC. INDIA.

3 Method used for analysis of API Submitted.
Finished Product manufacturer
4 Stability study data of API from API Irbesartan- LPGA: The firm has submitted copy of
manufacturer accelerated, 06 Months (40°C ± 2°C & 75±5%RH) & long
term, 24 Months (30°C ± 2°C & 75±5%RH) stability
study reports of 03 batches
Amlodipine:
The firm has submitted copy of accelerated, 06 Months
(40°C ± 2°C & 75±5%RH) & long term, 24 Months (30°C
± 2°C & 65±5%RH) stability study reports of 03 batches
5 Approval of API/ DML/GMP Irbesartan: Copy of Drug manufacturing license (License
certificate of API manufacturer no. ZJ210061) issued by ZHEJIANG MEDICAL
issued by concerned regulatory PRODUCTS ADMINISTRATION submitted, valid up to
authority of country of origin. 09-May-2024.
Amlodipine:
Copy of Drug manufacturing license (License no. S-
GMP/20051984) for Food & Drug Administration Gujrat
Estate India, valid upto 18-05-2022
6 Documents for the procurement of Irbesartan: Copy of form 6, form 7 & Commercial Invoice
API with approval from DRAP (in from M/s Zhejiang Huahai Pharmaceutical Co. Ltd.
case of import). Chuannan Duqiao, Linhai, Zhejiang. is submitted attested
by AD(Karachi).
Amlodipine:
Copy of Commercial Invoice from M/s Prudence Pharma
Chem, Plot No 7407, B/H, Lyka Lab, GIDC. INDIA.is
submitted attested by AD (Karachi).
7 Protocols followed for conduction of Submitted.
stability study
8 Method used for analysis of FPP Submitted.
9 Drug-excipients compatibility Same excipients used as used by innovator.
studies (where applicable)
10 Complete batch manufacturing The firm has submitted copy of Trial batch manufacturing
record of three stability batches. record. Details are as under:
Batch no. Batch Size Mfg. Started
21PD-3573-13-T 2500 3-2021
21PD-3573-13-T 2500 3-2021
21PD-3573-13-T 2500 3-2021
11 Record of comparative dissolution As per literature of the innovator available with the firm &
data (where applicable) as per Japanese Pharmacopeia.
The same has been demonstrated by the firm on their
product i.e. the product dissolve as per monograph.
Therefore, f2 calculations is not necessary.
12 Data of 03 batches will be supported Submitted.
chromatograms, Raw data sheets,
13 Compliance Record of HPLC Firm has submitted audit trail reports of stability studies
software 21CFR & audit trail reports of applied formulation.
on product testing.

Remarks by Evaluatorii
Firm has not submitted comparative dissolution data for both strengths while referring to the batch
release data performed as per JP monograph.
Decision of 317th meeting: Registration Board deferred the applications of IRMAX 100+5mg tablet &
IRMAX 100+10mg tablet for submission of Comparative Dissolution Profile data against the relevant
strength of Innovator drug product.
Firm’s response: Firm ha ssubmitted CDP studies gainst the innovator product of Iluamix tablets
manufactured by M/s Sawai Pharmaceutical Co., Ltd., Japan, in three dissolution medium of
Physiological pH 1.2, 4.5 & 6.8, with acceptable results for similarity factor f2.
Decision: Registration Board approved Irmax 100+5mg tablet & Irmax 100+10mg tablet with
Innovator’s specifications.
• Manufacturer shall submit fee of Rs. 7500/- for each strength for correction/pre-approval
change in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
129. Name and address of M/s Hilton Pharma Pvt Ltd. Plot No. 13-14, Sector 15,
manufacture / Applicant Korangi Industrial Area, Karachi, Pakistan
Brand Name + Dosage Form Agohil 25mg tablets
and Strength
Composition Each Film Coated Tablet Contains:
Agomelatine…………….25mg
Dairy No. date of R &I fee Form-5D Dy.No 217 dated 16-02-2016 Rs.50,000/- Dated
16-02-2016
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of form Form 5D
Finished product Innovator’s specifications
specifications
Pack size and Demand Price 14’s, 28’s, 56’s; As per SRO
Approval status of product in Valdoxan Tablet Approved by EMA
Reference Regulatory
Authorities
Me-too-status Modton 25mg tablet
GMP Status Renewla of DML vide letter No. F.2-14/85-Lic(Vol-I)
dated 30-06-2020
Remark of the Evaluator II
Decision:
Drug Agohil 25mg talet
Name of Manufacturer M/s Hilton Pharma Pvt Ltd. Plot No. 13-14, Sector 15, Korangi
Industrial Area, Karachi, Pakistan
Manufacturer of API M/s Changzhou Pharmaceutical Factory, Jiangsu Province, China.
API Lot No. AG191201
Description of Pack
Alu-Alu foil

Frequency Accelerated: 0,1,2,3,4,6 months
Batch No. AGO-418004-3 AGO-418004-4 AGO-418004-5
No. of Batches 03
REQUEST OF EXEMPTION FROM ON SITE INSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided following documents dated 23-02-2021, as per checklist approved by the Registration Board
in its 293rd Meeting:
Sr.# Data requirement Firm’s submission

1. Reference of previous approval Firm has referred to onsite inspection report of their
of applications with stability product “HILVEL 400mg + 100mg (Sofosbuvir
study data of the firm. +Velpatasvir)”, which was conducted on 14th December,
2017 and was presented in 277th meeting of Registration
Board held on 27-29th December, 2017.
“HILVEL 400mg / 100mg (Sofosbuvir + Velpatasvir” by
M/s. Hilton Pharma (Pvt.) Ltd., Karachi. Manufacturer
will place first three production batches on long term
stability studies throughout proposed shelf life and on
accelerated studies for six months.
Following two observations were reported in the report:
i. The HPLC software is 21 CFR compliant.
ii. Audit trail on the testing reports of Hilvel Tablets
400mg+100mg is available.
Adequate monitoring and control are available for
stability chamber. Chamber are controlled and monitored
through software having alarm system for alerts as well.
2. Certificate of Analysis of API Submitted.
Finished Product manufacturer.
3. Method used for analysis of API Analytical method for APIs has been submitted from API
along with COA. manufacturer as well as from M/s Highnoon Labs..
4. Stability study data of API from Firm has submitted both accelerated (40°C ± 2°C &
API manufacturer 75±5%RH) stability studies & long term (25°C ± 2°C &
60%±5%RH) stability studies reports of three batches for
6 & 24 months respectively.
5. Approval of API/ DML/GMP
Copy of GMP certificate eissued by Jiangsu Changzhou
certificate of API manufacturer
Drug Administration has been submitted valid upto 20-
02-2023
6. Documents for the procurement Copy of commercial invoice (Invoice# CYI19476)
of API with approval from attested by AD I&E DRAP, Karachi dated 06-02-2020
DRAP (in case of import). has been submitted. (Quantity: 1.5 Kg.)

7. Authorized Protocols/SOP for Firm has submitted SOP for new product development &
the development & stability stability protocol.
testing of trial batches.
8. Method used for analysis of FPP Drug product analytical method has been submitted.
9. Drug-excipients compatibility Firm has referred to the formulation of innovator product
studies (where applicable) for establishing drug-excipient compatibility.
10. Complete batch manufacturing Firm has provided Batch Manufacturing Record for all
record of three stability batches. the three batches of both strengths.
11. Record of comparative Comparative dissolution studies have been submitted in
dissolution data (where three physiological buffers i.e., pH 1.2, pH 4.5 & pH 6.8
applicable) against the Modton Tablet of M.s Nabiqasim Industries
with acceptable values of f2.
Trial Compoarator
Product product
Name Agohil Modton tablet 25mg
tablet 10mg
Batch AGO- MAB002
# 418204-5
12. Data of 03 batches will be Firm has submitted analytical record for both accelerated
supported by attested respective & long-term stability studies, including chromatograms,
documents like chromatograms, raw data sheets etc..
data sheets etc.
13. Compliance Record of HPLC Audit trail reports have been submitted.
14. Record of Digital data logger for Submitted.
Sr.# Observation Firm’s response
1. Stability studies of drug substance shall Firm has submitted long term stability studies
be submitted as per Zone-IVa of three batches from drug substance
conditions. manufacturer till 24 months as per Zone IVa.
2. Sample and standard concentration Assay of Agomelatine has been carried out as
applied for Assay test of drug substance per concentration of drug substance
by M/s Hilton is different from that manufacturer. Calculation sheet with raw
recommended in the analytical method data & revised specification of APl testing
from the drug substance manufacturer are submitted.
for the Assay of Agomelatine.
3. Results for CDP studies in pH 6.8 buffer Firm has submitted CDP studies in pH 6.8
have not been submitted. buffer against the Modton tablet of M/s
Nabiqasim with acceptable value of f2 factor.
4. Justification shall be submitted for not Innovator product is not available in the
performing CDP studies against the market. Therefore, generic comparator
innovator product. product Modton Tablets 25mg is being used
for CDP studies. This generic product has
already been registered from DRAP,
registration number 085661

5. Firm shall submit fee of Rs. 7,500 for Firm has submitted fee of Rs. 75,00/- vide
pre-approval change in product deposit slip# 24339917.
specifications from that initially
submitted in Form 5D dossier, as per
notification No.F.7-11/2012-
Decision: Approved with Innovator’s specifications.
Case no. 06 Registration applications for local manufacturing of (Human) drugs on

Form 5
Deferred cases
130. Name and address of manufacturer / M/s GT Pharma Pvt Ltd,23km, Raiwind Road, Lahore
Applicant contract manufacturing from
M/s Medisave Pharmaceuticals, Plot 578-579, Sundar
Industrial Estate, Lahore, Pakistan
Brand Name +Dosage Form + Gt Mox 400mg Tablet
Strength
Composition "Each Film Coated oral Tablet Contains:
Moxifloxacin as HCL…400MG"
Diary No. Date of R& I & fee Dy.No 8286 dated 25-02-2019 Rs.50,000/- Dated 25-
02-2019
Pharmacological Group Fluoroquinolones
J01MA14
Type of Form Form 5
Finished product Specification USP specs
Pack size & Demanded Price 5’s, 10’s, As per SRO.
Approval status of product in Moxifloxacin 400mg Tablet by Bayer Health Care
Reference Regulatory Authorities. USFDA Approved
Me-too status 074931
Moxpin 400 mg Tablet
M/s Winthrox Karachi . .
GMP status 11-12-2017 & 10-01-2018. GMP Certificate issued on
15-03-2018.
Remarks of the Evaluator (V) •
th
Decision of 295 meeting: Deferred for the following:
• Submit detail about total number of sections & total number of products already approved
on contract manufacturing of applicant.
• Submit contract manufacturing agreement between applicant and manufacturer.
• Justification for contract manufacturing as G T Pharma has own tablet section
• Capacity assessment of M/s Medisave Pharma
Firm’s response: Firm has referred to the Capacity assessment inspection report of M/s.
Medisave pharmaceuticals, Lahore presented in 317th meeting of Registration Board wherein
Board decided to allow contract manufacturing from M/s Medisave Pharmaceuticals, Plot 578-
579, Sundar Industrial Estate, Lahore for following sections:
• General Tablet Section (General),

• Capsule Section (Cephalosporin)
• Dry Powder Suspension Section (Cephalosporin)
• Dry Powder Injection Section (Cephalosporin)
• Liquid Injection
• Infusion (LVP) Section
• Liquid Syrup Section
Firm has also submitted contract manufacturing agreement with M/s Medisave
Pharmaceuticals.
Decision of 320th meeting: Approved. Registration letter will be issued upon submission of
compliance report from the contract manufacturer for further increase in testing capacity
especially HPLC, microbiological testing etc. to cater the need of pharmacopeial tesing of
already registered drug products, products under development and contract manufactured
products as decided in 317th meeting of Registration Board.
Applicant contract manufacturing from M/s Medisave
harmaceuticals, Plot 578-579, Sundar Industrial Estate,
Lahore, Pakistan
Brand Name +Dosage Form + Gt Cip 250mg Tablet
Strength
Composition "Each Film Coated Tablet Contains:
Ciprofloxacin HCL eq to Ciprofloxacin…250mg"
02-2019
Type of Form Form 5
Finished product Specification USP
Pack size & Demanded Price 10’s, As per SRO
Approval status of product in Cipro® (Ciprofloxacin Hydrochloride) Tablet
Reference Regulatory Authorities. Approved In USFDA with Box Warning.
"Ciprowrd 250mg Tablets
" Welwrd Pharmaceuticals, Plot No.3, Block No.A,
Phase I-II, Industrial Estate,Hattar"
15-03-2018.
Remarks of the Evaluator (V)
Decision of 295th meeting: Deferred for the following:
Pharmaceuticals.

Pharmaceuticals, Plot 578-579, Sundar Industrial
Estate, Lahore, Pakistan
Brand Name +Dosage Form + Gt Cip 500mg Tablet
Strength
Ciprofloxacin HCL eq to Ciprofloxacin…500mg"
02-2019
Type of Form Form 5
Approval status of product in Cipro® (Ciprofloxacin Hydrochloride) Tablet
Reference Regulatory Authorities. Approved In USFDA with Box Warning.
"Ciprowrd 500mg Tablets
" Welwrd Pharmaceuticals, Plot No.3, Block No.A,
Phase I-II, Industrial Estate,Hattar"
15-03-2018.
Pharmaceuticals.

Brand Name +Dosage Form + G-Mont chewable 5mg Tablet
Strength
Composition "Each chewable Tablet Contains:
Montelukast Sodium eq to Montelukast…5mg"
02-2019
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Pack size & Demanded Price 1x14’s, As per SRO.
Approval status of product in USFDA Approved.
Reference Regulatory Authorities.
Me-too status 079342 "NenKast 5 mg Tablets
Each Chewable Tablet contains:-
" Nenza Pharmaceuticals, 33-A, Hayatabad, Peshawar
15-03-2018.
Pharmaceuticals.
Brand Name +Dosage Form + G-Mont 10mg Tablet
Strength
Montelukast Sodium eq to Montelukast…10mg"
Diary No. Date of R& I & fee Dy.No 8275 dated 25-02-2019 Rs.50,000/- 25-02-2019
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5

Approval status of product in MHRA Approved.
Umcast 10mg Tablet
By M/s Umema Pharma Baluchistan.
15-03-2018.
Pharmaceuticals.
Brand Name +Dosage Form + Nestor 8mg Tablet
Strength
Ondansetron HCl dihydrate eq to Ondansetron…8mg"
02-2019
Pharmacological Group Antiemetics And Antinauseants
A04AA01 Serotonin (5HT3) antagonists
Type of Form Form 5
Finished product Specification USP.
Pack size & Demanded Price 10’s, As per SRO.
Approval status of product in ZOFRAN Tablets, 8 mg (ondansetron HCl dihydrate
Reference Regulatory Authorities. equivalent to 8 mg of ondansetron),USFDA Approved.
Ondonx Tablet ,Genix Pharma Karachi . .
15-03-2018.

Pharmaceuticals.
Brand Name +Dosage Form + Gt Line 600mg Tablet
Strength
Linezolid…600mg"
02-2019
Pharmacological Group Antibacterial for systemic use.
J01XX08
Type of Form Form-5
Finished product Specification Inhouse Spec.
Approval status of product in ZYVOX Tablets
Reference Regulatory Authorities. USFDA Approved.
Leckzolid 600mg Tablet
Medimarker’s Pharmaceutical, Hyderabad
15-03-2018.

Pharmaceuticals.
Brand Name +Dosage Form + Gt Mycin 250mg Tablet
Strength
Clarithromycin HCl eq to Clarithromycin…250mg"
02-2019
Pharmacological Group Macrolide
Type of Form Form-5
Approval status of product in Biaxin 250mg (Available as only Clarithromycin
Reference Regulatory Authorities. without HCl)
**Federal Register Determination That Product Was Not
Discontinued Or Withdrawn For Safety Or Efficacy
Reasons**
USFDA Approved.
Claramet -250 Tablets
M/s Metro Pharmaceuticals,Plot No.14, Street No.SS-
2,National Industrial Zone RCCI,Rawat, Islamabad
15-03-2018.
Remarks of the Evaluator (V) • Details about total number of sections & total
number of products already approved on contract
manufacturing of applicant.
• Submission of agreement between applicant and
manufacturer.
• Evidence of approval of applied formulation as
“Clarithromycin HCl eq to
Clarithromycin…250mg" in reference regulatory
authorities/agencies which were
declared/approved by the Registration Board in
its 275th meeting.

• Submit composition of applied formulation in line with label claim of reference product
i.e. “Clarithromycin as HCl 250mg film coated tablet.
Pharmaceuticals.
Brand Name +Dosage Form + Gt Mycin 500mg Tablet
Strength
Clarithromycin HCl eq to Clarithromycin…500mg"
02-2019
Type of Form Form-5
Approval status of product in Biaxin 500mg
Reference Regulatory Authorities. **Federal Register Determination That Product Was Not
Discontinued Or Withdrawn For Safety Or Efficacy
Reasons**
USFDA Approved.
Claramet -500 Tablets
M/s Metro Pharmaceuticals,Plot No.14, Street No.SS-
2,National Industrial Zone RCCI,Rawat, Islamabad
15-03-2018.

• Submit composition of applied formulation in line with label claim of reference product
i.e. “Clarithromycin as HCl 250mg film coated tablet.
Pharmaceuticals.
Brand Name +Dosage Form + Gt Xime 400mg Capsule
Strength
Composition "Each Capsule Contains:
Cefixime Trihydrate eq to Cefixime…400mg"
Pharmacological Group Third-generation cephalosporins
Type of Form Form 5
Finished product Specification JP
Approval status of product in SUPRAX® (cefixime) capsules
Reference Regulatory Authorities. USFDA Approved.
Me-too status 055093; Vasix 400mg ‘
By M/s Alfalah Pharma (Pvt.) Ltd.,
15-03-2018.

Pharmaceuticals.
Brand Name +Dosage Form + Gt Xime 100mg Dry powder suspension
Strength
Composition "Each 5ml of reconstituted suspension contains:
02-2019
Pharmacological Group Third-generation cephalosporin
Type of Form Form 5
Pack size & Demanded Price 30ml bottle, As per SRO.
Stlicef Dry Suspension 200mg
Treat Pharma A-37, Industrial Estate Kohat Road,Bnnu
(contract manufacturing will be conducted by M/s.
Shawan Pharmaceuticals, Rawat)"
15-03-2018.
Pharmaceuticals.

Brand Name +Dosage Form + Gt Xime 200mg Dry powder suspension
Strength
Composition "Each 5ml of reconstituted suspension contains:
Type of Form Form 5
Pack size & Demanded Price 30ml bottle, As per SRO.
Me-too status 073248; Stlicef Dry Suspension 200mg
Treat Pharma A-37, Industrial Estate Kohat Road,Bnnu
(contract manufacturing will be conducted by M/s.
Shawan Pharmaceuticals, Rawat)"
15-03-2018.
Pharmaceuticals.

Brand Name +Dosage Form + Gt Zone 250mg Injection IV
Strength
Composition "Each Vial Contains:
Ceftriaxone sodium eq to Ceftriaxone…250mg"
02-2019
Pharmacological Group Third-generation cephalosporins
J01DD04
Type of Form Form 5
Pack size & Demanded Price 1’s Type II Vial, as per SRO.
Approval status of product in Rocephin 250 mg Powder for solution for injection.
Reference Regulatory Authorities. MHRA Approved.
Breezon Injection 250mg
M/s Pliva Balochistan
15-03-2018.
• Clarification regarding brand name is required whether it is as GT CIP or GT Zone.
Pharmaceuticals.
Brand Name +Dosage Form + Gt Zone 500mg Injection
Strength
Ceftriaxone sodium eq to Ceftriaxone…500mg"
02-2019

Type of Form Form 5
Pack size & Demanded Price 1’s, Glass III vials, As per SRO
Approval status of product in Rocephin powder for solution for Injection vials by
Reference Regulatory Authorities. Roche (MHRA Approved)
Me-too status 062328 "Cefaben 500 mg IV Injection
" Imco Pharmaceuticals Laboratories,
73/A.S Industrial Estate, Jamrud Road,
Peshawar.
(contract manufacturing conducted by M/s. Caraway
Pharmaceuticals, Rawat, Islamabad)"
15-03-2018.
Pharmaceuticals.
Brand Name +Dosage Form + Gt Zone 1g Injection
Strength
Ceftriaxone as sodium eq to Ceftriaxone…1g"
02-2019
Type of Form Form 5
Pack size & Demanded Price Glass II vials, As per SRO
Approval status of product in Rocephin powder for solution for Injection vials by
Reference Regulatory Authorities. Roche (MHRA Approved)

Martixon 1gm I.V Dry powder Injection by Alkemy
Hyderabad
15-03-2018.
Pharmaceuticals.
Brand Name +Dosage Form + C Pime Injection 500mg
Strength
Cefepime HCL…500 mg
Arginine…326.5 mg
02-2019
Pharmacological Group Fourth-generation cephalosporins
Type of Form Form 5
Pack size & Demanded Price Type II, 1’s Vial, As per SRO.
Approval status of product in Maxipime (cefepime hydrochloride) for injection, for
Reference Regulatory Authorities. intravenous or intramuscular use
USFDA Approved
Me-too status 055465 KC-Pime 500mg Injection
M/s Karachi Chemical Industrial
15-03-2018.
Remarks of the Evaluator (V) •
th

Pharmaceuticals.
• Registration letter will be issued upon submission of compliance report from the
contract manufacturer for further increase in testing capacity especially HPLC,
microbiological testing etc. to cater the need of pharmacopeial tesing of already
registered drug products, products under development and contract manufactured
• Registration Board further directed the firm to revise th label claim for the declaration
of content of Arginine, as per innovator product along with submission of full fee that
is 75,000/- as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + C Pime Injection 1000mg
Strength
Cefepime as HCL…1000 mg
Arginine…725 mg
02-2019
Pharmacological Group Fourth-generation cephalosporins
Type of Form Form 5
Pack size & Demanded Price Type II, 1’s Vial, As per SRO.
Approval status of product in Maxipime (cefepime hydrochloride) for injection, for
Reference Regulatory Authorities. intravenous or intramuscular use
USFDA Approved
KC-Pime 1000mg Injection
M/s Karachi Chemical Industrial
15-03-2018.
Remarks of the Evaluator (V) • Approval of section/manufacturing facility by
the Central Licensing Board. However, you may
submit panel inspection report for renewal of
DML verifying the section/manufacturing
facility.
th

Pharmaceuticals.
• Registration letter will be issued upon submission of compliance report from the
contract manufacturer for further increase in testing capacity especially HPLC,
microbiological testing etc. to cater the need of pharmacopeial tesing of already
registered drug products, products under development and contract manufactured
• Registration Board further directed the firm to revise the label claim for the
declaration of content of Arginine, as per innovator product along with submission
of full fee that is 75,000-/- as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
147. Name and address of "M/s Next Pharmaceutical Products Private Limited. Plot
manufacturer / Applicant No. 44 A-B, Sundar Industrial Estate, Lahore
Contract manufacturing by
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-
km,Ferozepur Road, Lahore"
Brand Name +Dosage Form + D-Next 5mg/ml IV/IM Injection
Strength
Composition "Each 1ml Contains:
Cholecalciferol (Vitamin D3)…5mg"
Diary No. Date of R& I & fee Dy. No 17650 dated 11-05-2018 Rs.20,000/- Dated 11-05-
2018 Rs. 30,000/- dated 27-06-2019
Pharmacological Group Vitamin
Type of Form Form 5
Finished product Manufacturer specifications
Specifications
Pack size & Demanded Price As per SRO
Approval status of product in Approved by ANSM of France
Authorities
Me-too status (with strength D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
and dosage form)
GMP status Last GMP inspection dated 5th & 27th December, 2017
conclusion by Panel ―The firm (M/s NovaMed
Pharmaceuticals Pvt. Ltd. Lahore) is compliant to Good cGMP
guidelines at the time of inspection.

Remarks of the EvaluatorII Form 5 was initially submitted from the manufacturer i.e. M/s
Novamed Pharmaceuticals (Pvt.) Ltd. 28-km, Ferozepur Road,
Lahore.
Subsequently fresh Form 5 has been submitted by the applicant
i.e., M/s Next Pharmaceutical Products Private Limited. Plot
No. 44 A-B, Sundar Industrial Estate, Lahore, dated 25-07-
2019.
• Reference product is available in ampoule whereas firm

has applied for vial.
Decision of 291st meeting: Registration Board decided to defer all applied products of contract
manufacturing from M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km, Ferozepur Road, Lahore,
for assessment of manufacturing and quality control capacity of M/s Novamed Pharmaceuticals
(Pvt) Ltd. 28-km, Ferozepur Road, Lahore. Moreover, clarification shall be submitted regarding
container closure system, since reference product is available in ampoule whereas firm has
applied for vial.
Firm’s response: Firm has referred to the Capacity assessment inspection report of M/s Novamed
Pharmaceuticals Pvt Ltd, 28km Ferozepur Road, Lahore presented in 295th meeting of
Registration Board wherein Board decided to allow contract manufacturing from M/s Novamed
Pharmaceuticals Pvt Ltd, 28km Ferozepur Road, Lahore for following sections:
• Dry Powder Injection (Cephalosporin) Section

• Dry Powder Suspension (Cephalosporin) Section
• Capsule (Cephalosporin) Section
• General Liquid Injection (Ampoule)
• General Liquid Injection Vials (SVP)
Decision of 320th meeting: Registration Board deferred the applications of contract
manufcaturin from M/s Medisave harmaceuticals, Plot 578-579, Sundar Industrial Estate,
Lahore, Pakistan for submission of upgradation plan regarding increase in testing capacity
especially HPLC, microbilogical testing etc to cater the need of pharmacopeial tesing of
148. Name and address of "M/s Next Pharmaceutical Products Private

Manufacturer/Applicant Limited.
Plot No. 44 A-B, Sundar Industrial Estate, Lahore
By
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-
km,Ferozepur Road, Lahore"
Brand Name + Dosage Form + Strength Cefinext 200mg/5ml Suspension
Cefixime(as trihydrate)…200mg/5ml"
Diary No. D of R & I & Fee Dy No. 17661 ; 11-05-18: Rs.20,000
Pharmacological group Cephalosporin
Type of Form Form 5
Finished product Specifications USP Specifications
Pack Size & demanded price 1’s: As per SRO
Approval status of product in reference Approved in USFDA
regulatory authorities
Me-too status Rofil 200mg/5ml suspension of Amrose
Pharmaceuticals, Karachi.
GMP Status

Sr.No. Queries Response
1. Fee for contract manufacturing is Applicant has submitted
50,000, submit differential fee. Fee Challan of
Rs.30,000/- dated 27-
006-2019.
2. Mention type of primary ------
packaging material.
Decision of 290th meeting: Deferred for clarification regarding type of primary packaging
material for applied formulation and assessment of capacity of M/s Novamed.
Firm’s response: Firm has referred to the Capacity assessment inspection report of M/s
Novamed Pharmaceuticals Pvt Ltd, 28km Ferozepur Road, Lahore presented in 295th meeting
of Registration Board wherein Board decided to allow contract manufacturing from M/s
Novamed Pharmaceuticals Pvt Ltd, 28km Ferozepur Road, Lahore for following sections:
• Dry Powder Injection (Cephalosporin) Section

• Dry Powder Suspension (Cephalosporin) Section
• Capsule (Cephalosporin) Section
• General Liquid Injection (Ampoule)
• General Liquid Injection Vials (SVP)
Moreover firm has submitted primary packaging container as ”Amber glass bottle” and also
requested for change of brand name from “Cefinext 200mg/5ml to Cefinext DS 200mg/5ml”
Decision: Approved.
149. Name and address of manufacturer/ M/s Seraph Pharmaceuticals, Plot No. 210, Industrial
Applicant Triangle, Kahuta Road, Islamabad (Contract giver)
M/s Swiss Pharmaceuticals (Pvt.) Ltd., A-159, S.I.T.E
Super Highway, Karachi (Contract acceptor) (Ampoule &
Vial injection).
Brand Name + Dosage Form + Meco 500mcg/ml Injection.
Strength
Composition Each ml Contains:
Mecobalamin ……………………500mcg
Diary No. Date of R & I & fee Dy. No 11930 dated 05-03-2019; Rs. 50,000/- dated 05-03-
2019.
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of Form Form-5
Finished product Specification Manufacturer specifications.
Pack size & Demanded Price 1ml x 1’s, 5’s, 10’s & as per SRO.
Approval status of product in Comezengen injection 500 mcg, PMDA Japan Approved.
Me-too status Flench injection, Tabros Pharma, Reg. no. 029050.
GMP status Same as above.
Remarks of the Evaluator • Contract giver has 07 approved sections.
• Applicant has submitted that total number of registered
products on contract basis are 06.
• Firm has provided finished product specifications with
submission of 7500/- vide slip No. 641042980 dated 27-
08-2021.
th
Decision of 312 meeting: Deferred to review and present requirement of JP monograph
regarding storage and testing of drug substance and container closure system of drug product.
Firm’s response: Firm has submitted analytical method for drug substance as per JP
specifications along with details of container closure system as amber glass ampoule.

• Decision: Approved with JP specifications. The firm shall submit fee of Rs. 7500/- for
correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
150.Name and address of M/s Reign Pharmaceuticals PCSIR-KLC Pvt Ltd. TBIC
manufacturer / Applicant Building-1, PCSIR Laboratories Complex, Shahrahe Dr.
Salim-us-Zaman Siddiqui, Off University Road, Karachi
M/s Global Pharmaceuticals Pvt Ltd. Plot # 204-205,
Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Piptam Injection 4.5gm
Strength
Piperacillin Sodium Eq To Piperacillin…4gm
Tazobactam Sodium Eq To Tazobactam…500mg
Diary No. Date of R& I & fee Dy. No.12640; 06-03-2019; Rs.50,000/- 06-03-2019
Type of Form Form-5
Finished product Specification Manufacturer specifications
Approval status of product in Approved by US FDA
Me-too status Tanzo Injection of M/s Bosch
GMP status Copy of GMP certificate of M/s Global
Pharmaceuticals dated 24-12-2018 based on the
inspection dated 24-10-2018. The certificate was valid
till 23-10-2021.
Remarks of the Evaluator. Registration Board was apprised that in the initial
application, the applicant i.e. Reign Pharmaceuticals has
not specified any contract manufacturer. Upon the
response submitted by the firm they have specified the
contract manufacturer i.e. Global Pharmaceuticals.
Decision: Approved with USP specifications.
• Registration Board Authorized its Chairman for issuance of registration letter upon
capacity assessment of manufacturing and testing facility of M/s Global
Pharmaceuticals (Pvt) Ltd. Plot No. 204-205, Industrial Triangle Kahuta Road
Islamabad.
• Registration Board further directed the applicant to submit fee of Rs. 75,000/- for
change/correction in Form 5 regarding name of the contract manufacturer as per
Brand Name +Dosage Form + Piptam Injection 2.25gm
Strength
Piperacillin Sodium Eq To Piperacillin…2gm
Tazobactam Sodium Eq To Tazobactam…250mg

Type of Form Form-5
Me-too status Tanzo Injection of M/s Bosch
till 23-10-2021.
Islamabad.
Brand Name +Dosage Form + Meren Injection 500mg
Strength
Meropenem Trihydrate Eq. To Meropenem…500mg
Type of Form Form-5
Me-too status Mopen 500mg Injection of M/s Hilton
Pharma,Karachi.
till 23-10-2021.

Islamabad.
Brand Name +Dosage Form + Meren Injection 1gm
Strength
Meropenem Trihydrate Eq. To Meropenem…1Gm
Type of Form Form-5
Me-too status Mopen 1gm Injection of M/s Hilton Pharma,Karachi.
till 23-10-2021.
Islamabad.
154.Name and address
of M/s Reign Pharmaceuticals PCSIR-KLC Pvt Ltd. TBIC
Brand Name +Dosage Form + Imicil Injection 500mg/500mg IM/IV
Strength
Imipenem As Monohydrate…500mg

Cilastatin As Sodium…500mg
Type of Form Form-5
Me-too status Cilapen Injections of M/s Bosch Pharmaceuticals,
Karachi.
GMP status Firm has submitted copy of GMP certificate of M/s
Global Pharmaceuticals dated 24-12-2018 based on the
till 23-10-2021.
Islamabad.
155.Name and address of M/s Reign Pharmaceuticals PCSIR-KLC Pvt Ltd.
manufacturer / Applicant TBIC Building-1, PCSIR Laboratories Complex,
Shahrahe Dr. Salim-us-Zaman Siddiqui, Off
University Road, Karachi
By
M/s Global Pharmaceuticals Pvt Ltd
Plot # 204-205, Industrial Triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Imicil Injection 250mg/250mg IM/IV
Strength
Imipenem As Monohydrate…250mg
Cilastatin As Sodium…250mg
Type of Form Form-5
Me-too status Cilapen Injections of M/s Bosch Pharmaceuticals,
Karachi.
till 23-10-2021.

Decision: Registration Board was apprised that in 313th meeting same products was
deferred for submission of product development studies keeping in view the innovator
product and product testing and stability studies by complying USP monograph by Global
Pharmaceuticals and accordingly the Board deferred instant application and advised to
consider alongwith submission of same data.
• Registration Board directed the firm to submit fee of Rs. 75,000/- for
Brand Name +Dosage Form + Teinin Injection 400mg
Strength
Teicoplanin Powder Sterile…400mg
Type of Form Form-5
Approval status of product in Approved by MHRA of UK
Me-too status Targocid Injection 200mg of M/s Hoechst Pakistan
Ltd,
Karachi 019504
till 23-10-2021.
Decision: Deferred for:
• Justification of applied dosage form since innovator product is available as
lyophilisd vial whereas firm has applied in ready to fill dosage form.
• Submission of fee of Rs. 75,000/- for change/correction in Form 5 regarding name
of the contract manufacturer as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.

M/s Vision Pharmaceuticals Pvt Ltd. Plot # 22-23,
Brand Name +Dosage Form + Tigcil Injection 50mg
Strength
Tigecycline…50mg
Type of Form Form-5
Me-too status Tigewel Injection of M/s Welwrd Pharma (Reg.#
082530)
till 23-10-2021.
Decision: Deferred for:
• Justification of applied dosage form since innovator product is available as
lyophilisd vial whereas firm has applied ready to fill dosage form.
• Submission of fee of Rs. 75,000/- for change/correction in Form 5 regarding name
of the contract manufacturer as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
Brand Name +Dosage Form + OM-R Injection 40mg
Strength
Omeprazole As Sodium…40mg
Pharmacological Group PPI
Type of Form Form-5
Me-too status Zegrid 40mg injection of M/s Shaigan
till 23-10-2021.

Decision: Approved with Innovators specifications.
Islamabad.
Brand Name +Dosage Form + Renzole Injection 40mg
Strength
Esomeprazole As Sodium…40mg
Pharmacological Group PPI
Type of Form Form-5
Me-too status Nexium 40mg injection of M/s Getz
GMP status --
Decision: Approved with Innovators specifications.
Islamabad.

Brand Name +Dosage Form + Vancoren Injection 500mg
Strength
Vancomycin As Hcl…500mg
Type of Form Form-5
Approval status of product in Approved by MHRA of UK
Me-too status Wangkolin 500mg Injection by M/s Himont
(Reg#031032)
till 23-10-2021.
Islamabad.
Brand Name +Dosage Form + Ceftam Injection 2gm
Strength
Cefoperazone Sodium…1000mg
Sulbactam Sodium…1000mg
Type of Form Form-5
Approval status of product in Approved in 03 European countries, i.e., Czech
Reference Regulatory Authorities. Republic, Poland and Slovakia
Me-too status Q- Bact 2gm Injection of High- Q Karachi 061170
till 23-10-2021.

Decision: Approved with JP specifications.
Islamabad.
Brand Name +Dosage Form + Cepime 1gm Injection
Strength
Cefepime As Hcl With L-Arginine…1000mg
Type of Form Form-5
Me-too status Nuxipim 1g Injection of Bosch
till 23-10-2021.
Islamabad.

Brand Name +Dosage Form + Cepime Injection 500mg
Strength
Cefepime HCl With L Arginine…500mg
Type of Form Form-5
Me-too status Nuxipim 1g Injection of Bosch
till 23-10-2021.
Islamabad.
Brand Name +Dosage Form + Ceftam Injection 1gm
Strength
Cefoperazone Sodium…500mg
Sulbactam Sodium…500mg
Type of Form Form-5
Approval status of product in Approved by PMDA of Japan
Me-too status Ectafin Injection 1gm I/V of M/s Hi-Medic Pharma,
Lahore

till 23-10-2021.
Decision: Approved with JP specifications.
Islamabad.
165.Name and address of manufacturer / M/s Medera Pharmaceuticals Pvt. Ltd, Plot 2, Street 4,
Applicant National Industrial Zone, Rawat
Brand Name +Dosage Form + Terbinafine Tablet 250 mg
Strength Terbimed, Finomed, Binomed
Diary No. Date of R& I & fee Duplicate dossier
Composition
Terbinafine Hydrochloride eq. to Terbinafine ..250mg
Pharmacological Group Antifungals for systemic use (D01BA02)
Type of Form Form-5
Finished product Specification Inhouse
Pack size & Demanded Price 10’s Alu Alu Blister, As per SRO
Approval status of product in Lamisil terbinafine 250mg (as hydrochloride)
Reference Regulatory Authorities. TGA Approved uncoated.
081184; Cutis 250mg Tablet M/s Tabros Pharma
Me-too status
Karachi.
06-02-2018 Conclusion:
GMP status Keeping in view of the above facts, overall GMP
compliance is found Good as of today.
Evidence of international availability and me-too as
film coated tablet is required.
Remarks of the Evaluator. Firm has provided evidence of film coated tablets
which could not be confirmed.
Present in USP
Previous Decision(288): Deferred for following:
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm
Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were adopted by the Registration Board in its 275th meeting
Confirmation from R&I section for date of submission of original dossier along with
details of submitted fee.
Evaluation by PEC:
Firm has revised their formulation from film coated to uncoated tablet with submission of Rs.
5000/- dated 26-06-2019.
Firm has not provided evidence for confirmation from R&I section for date of submission of
original dossier along with details of submitted fee.
Decision of 291st meeting: The Registration Board deferred the applied formulation for evidence
for confirmation from R&I section for date of submission of original dossier along with details
of submitted fee.

Evaluation by PEC: Firm has submitted copy of R&I receiving dated 17-08-2017, which has
been verified from the R&I incharge against the diary no. 12273 dated 17-08-2017.
• The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product
Routine Applications of Locally Manufactured Drugs (Veterinary):
166. Name and address of manufacturer / M/s Mallard Pharmaceuticals (Pvt) Ltd., 23-Km
Applicant Lahore Road, Multan
Brand Name +Dosage Form + Strength Florfen Col Liquid
Composition Each 100ml liquid contains:
Florfenicol………………….10g
Colistin sulphate…………….50 MIU
Type of Form Form-5
Finished Product Specification Manufacturer specifications
Pack size & Demanded Price 50ml, 100ml, 200ml, 400ml, 500ml, 1000ml;
Decontrolled
Me-too status Florobex C Liquid of M/s Elegance Pharma
(Reg#078286)
GMP status The firm is granted GMP certificate based on
inspection conducted on 13-08-2020.
Remarks of the Evaluator. The R&I receipt has been verified from the Incharge
R&I against the diary no. mentioned above.
Decision: Referred to Expert Working Group for review of applied formulation.
Brand Name +Dosage Form + Strength Feverex Powder
Composition Each 100g Powder contains:
Paracetamol …………………..20g
Potassium carbonate.………….12.5g
Sodium carbonate……………..12.5g
Vitamin E……………………..12.5g
Vitamin C…………………….5g
Pharmacological Group Anti-inflammatory, Anti-pyretic
Type of Form Form-5
Pack size & Demanded Price 50g, 100g, 200g, 400g, 500g, 1000g; Decontrolled
Me-too status Paracet WSP of M/s Decent Pharma (Reg#079826)
Decision: Approved with Innovcator’s specifications.
Brand Name +Dosage Form + Strength Vitamall Injection
Vitamin A……………………80,000 IU
Vitamin D3…………………..40,000 IU

Vitamin E……………………20mg
Pharmacological Group Vitamins
Type of Form Form-5
Pack size & Demanded Price 50ml; Decontrolled
Me-too status Vitazak Injection of M/s Zakphos Pharma
(Reg#052316)
Decision: Approved with Innovcator’s specifications.
Agenda of Evaluator PEC-III
Case No. 01 Registration applications of cases of PINSTECH
DRAP Authority in its 133rd meeting held on April 13, 2022 while considering the request of
PINSTECH for exemption of Form 5F for radiopharmaceuticals decided as under:
I. The Authority decided to grant 06 months relaxation under SRO 713(1)/2018 from Form 5-
F (CTD) for following radiopharmaceuticals as CTD is not applicable for
radiopharmaceuticals:
a. DISIDA (Hepatobiliary Agent in Diagnosis of Hepatocellular Carcinoma)
b. DMSA (Renal Static Imaging Agent: When radiolabeled with Technelium-99m)
c. PINTHERA (Radiolabeled Somatostatin Receptor analogue for treatment of
neuroendocrine Tumors).
d. HYNIC-TATE (For diagnosis of Neuroendocrine Tumors).
e. [131 I-MIBG]iobenguane 1131 (Treatment-resistant neuroblastoma (NB),
unresectable or metastatic pheochromocytoma (PC) and paraganglioma (PG).
DRAP Authority further in its 134th meeting held on 29-04-2022 further Advised PE&R Division
to process applications of radiopharmaceuticals of M/s PINSTECH on priority / out of queue,
wherein relaxation in the Form 5-F was granted by the Authority.
Accordingly, the following applications have been received and evaluated and presented before the
Board for consideration.
169. Name and address of manufacturer M/s Pakistan Institute of Nuclear Science &
/ Applicant Technology, Nilore Islamabad.
Brand Name +Dosage Form + PINSCAN DISIDA (Freeze dried powder for
Strength reconstitution)
Composition N-(2,6 Diisopropyl- phenyl carbamoyl methyl
iminodiacetic acid)…… 20mg
Stannous (II) Chloride Dihydrate……0.24mg
Diary No. Date of R& I & fee Dy. No 17772: 17-06-2022
PKR. 75,000/-: 17-06-2022
Pharmacological Group Hepatobiliary agent in diagnosis of hepatocellular
carcinoma
Type of Form Form 5D

Finished Product Specification Not submitted
Pack size & demanded price Rs. 900 / Vial, 5’s
Approval status of product in TGA Australia (HEPATOLITE kit for production of
Reference Regulatory Authorities. Technetium(99mTc) disofenin powder for injection
multidose vial)
Powder for Injection (White crystalline plug)
Me-too status NA
GMP status Inspection report of the firm dated 17-05-2017 wherein
the panel recommended renewal of DML was
presented by the firm.
Clinical indications of innovator’s Indicated as an adjunct in the diagnosis of
product hepatobiliary disease
Remarks of the Evaluator .3
• GMP inspection report conducted within a period of
last three years.
• Provide reference of finished product specification
whether pharmacopoeial, in-house or as per
innovator’s product. Submit copy of official
monograph in case of pharmacopoeial specifications.
• Revise your label claim as per the innovator’s drug
product as per follows, since you have mentioned
chemical name of Disofenin in the label claim.
Each vial contains:
Disofenin……………. 20 mg
Stannous chloride dihydrate………. 0.24 mg
Decision: Registration Board decided to approve the product with following label
claim:
Each vial contains:
Disofenin……………. 20 mg
Stannous chloride dihydrate………. 0.24 mg
Firm will submit following documents and the Board Authorized its Chairman for
issuance of registration letter.
• Finished product specification along with applicable fee for revision of
• Revised form 5D along with relvant annexures for the revised label claim.
• Updated GMP certificate / inspection report of the firm conducted within a
period of last three years.
Brand Name +Dosage Form + PINSCAN DMSA (Freeze dried powder for
Strength reconstitution)
Composition Meso-2,3-dimercaptosuccinic acid…. 1 mg
Stannous chloride dehydrate…….0.4 mg
Ascorbic acid……0.7 mg
Inositol………50.0 mg
PKR. 75,000/-: 17-06-2022
Pharmacological Group Renal static imaging agent
Pack size & demanded price Rs. 800 / Vial, 5’s
Approval status of product in TGA Australia

(RADPHARM DMSA kit for the production of
Technetium (99mTc) succimer powder for injection
multidose vial) Lyophilised white powder
Me-too status NA
Clinical indications of innovator’s Used as a static renal imaging pharmaceutical and is
product particularly suited for evaluation of renal cortex,
deliniation of renal space occupying lesions,
determination of intrarenal function, distribution and
identification of ectopic renal sites.
Remarks of the Evaluator3. • GMP inspection report conducted within a period of
last three years.
product as per follows:
Each vial contains:
Succimer………… 1 mg
claim:
Each vial contains:
Succimer………… 1 mg
• Finished product specification
• Revised form 5D along with relvant annexures for the revised formulation along
with the submission of applicable fee that is 75,000/- for pre-registration
variation for change in composition of the applied product as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Iodine-131 Meta-iodobenzylguanidine (Iobenguane I-
Strength 131) Injectable solution
Composition Iobenguane I 131…….. 555 MBq/mL (15 mCi/mL)
PKR. 75,000/-: 17-06-2022
Pharmacological Group Neuroectodermal agent in diagnosis of
pheochromocytoma
Pack size & demanded price Rs. 900 / Vial
Approval status of product in USFDA
Reference Regulatory Authorities. AZEDRA (iobenguane I 131) 555 MBq/mL (15
mCi/mL) injection
(sterile, clear, colorless to pale yellow injectable
solution)
Me-too status NA

Clinical indications of innovator’s Radioactive therapeutic agent indicated for the
product treatment of adult and pediatric patients 12 years and
older with iobenguane scan positive, unresectable,
locally advanced or metastatic pheochromocytoma or
paraganglioma who require systemic anticancer
therapy
last three years.
Each vial contains:
Iobenguane I 131…….. 555 MBq/mL (15 mCi/mL)
claim:
Each vial contains:
Iobenguane I 131…….. 555 MBq/mL (15 mCi/mL)
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + PINTHERA (Freeze dried powder for reconstitution)
Strength
Composition DOTA-Tyr3-Octreotate, Somatostatin analogue
conjugated with metal chelating moiety 1,4,7,10-
tetraazacylododecane-1,4,7,10-tetraacetic acid
(DOTA)….260ug per vial
Lu-177….200mCi
PKR. 75,000/-: 17-06-2022
Pharmacological Group Radiolabelled somatostatin receptor analogue for
treatment of neuroendocrine tumours.
Pack size & demanded price Rs. 150,000/ Vial
Approval status of product in USFDA
Reference Regulatory Authorities. (LUTATHERA) Sterile, clear, colorless to slightly
yellow solution for intravenous use
Me-too status NA

Clinical indications of innovator’s Radiolabelled somatostatin analog indicated for the
product treatment of somatostatin receptor-positive
gastroenteropancreatic neuroendocrine tumours (GEP-
NETs), including foregut, midgut, and hindgut
neuroendocrine tumours in adults
Remarks of the Evaluator3. • GMP inspection report conducted within a period of
last three years.
• Revise the applied dosage form from lyophilized
powder to injectable solution as per the innovator’s
drug product along with submission of full fee of
registration for pre-registration variation as per SRO
No. F.7-11/2012-B&A/DRAP dated 7th May 2021.
Each vial contains:
Lutetium Lu 177 dotatate…………370 MBq/mL (10
mCi/mL)
claim:
Each vial contains:
Lutetium Lu 177 dotatate…………370 MBq/mL (10 mCi/mL)
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + PINSCAN (HYNIC-TATAE)
Strength
Composition HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt 16 mcg
EDDA (Ethylenediamine-N,N’-diacetic acid)10 mg
PKR. 75,000/-: 17-06-2022
Pharmacological Group Somatostatin receptor analogue for treatment of
neuroendocrine tumours.
Pack size & demanded price Rs. 15,000/ Vial
Approval status of product in MHRA UK
Reference Regulatory Authorities. TEKTROTYD 16 micrograms kit for
radiopharmaceutical preparation
(White or almost white lyophilisates)
Me-too status NA
presented by the firm.444444443q
Clinical indications of innovator’s This medicinal product is for diagnostic use only.
product 99mTc-EDDA/HYNIC-TOC specifically binds to
somatostatin receptors. After radiolabelling with
sodium pertechnetate (99mTc) solution, the solution of
99mTcEDDA/HYNIC-TOC obtained is indicated in
adult patients with gastro-enteropancreatic
neuroendocrine tumours (GEP-NET) for localizing
primary tumours and their metastases
last three years.
• Revise the applied formulation from a single vial
containing both drug substance to two different vials
each containing one drug substance as per the
innovator’s drug product along with submission of
full fee of registration for pre-registration variation as
per SRO No. F.7-11/2012-B&A/DRAP dated 7th
May 2021.
Vial I contains:
HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt…16 μg
Vial II contains:
EDDA (Ethylenediamine-N,N’-diacetic acid)…10
mg
claim:
Vial I contains:
HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt……..16 μg
Vial II contains:
EDDA (Ethylenediamine-N,N’-diacetic acid)…….10 mg
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Case No. 02 Registration applications of New section / New License

Case No. 02: M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat, Rawalpindi
M/s Biogen Pharmaceuticals, Rawalpindi has been granted new license (DML No. 000911) by way
of formulation by Licensing division DRAP dated 13-02-2020. Now the firm has submitted following
applications as per the details mentioned in the table below:
Name of Section Considered till 317th RB Freshly applied

meeting
No of No of products No of No of
molecules molecules products
Dry Vial section (Cephalosporin) 03 12 - -
Dry suspension section 01 02 - -
(Cephalosporin)
Capsule section (Cephalosporin) 02 02 - -
Ampoule Section SVP (General) 05 07 - -
Capsule section (General) 02 04 01 01
Dry Vial section (General) 03 04 - -
Soft gel capsule general section 02 03 - -
Hydrocortisone injection (steroid) 01 03 - -
Sachet section (General) 01 01 - -
Dry Vial section (Carbapenem) 02 03 - -
Cream section (general) 02 02 - -
Ointment section (General) 01 01 - -
Lotion section (General) 01 01 - -
Infusion Section (General) - - 02 02
Infusion Section (General): 02 Molecules / 02 Products
174. Name, address of Applicant / M/s Biogen Life Sciences, 8Km, Chakbeli
Marketing Authorization Holder Road Rawat, Rawalpindi
Name, address of Manufacturing site. M/s Biogen Life Sciences, 8Km, Chakbeli Road
Rawat, Rawalpindi
☐ Importer
giver)
2020.
Evidence of approval of manufacturing Firm has submitted copy of section approval
facility letter dated 14-02-2020 which specifies Infusion
section (General).
☐ Export sale
Dy. No. and date of submission Dy. No. 1896: 20-01-2022
The proposed proprietary name / brand LINZOGEN 600mg/300ml Solution for
name Infusion

Strength / concentration of drug of Active Each vial of 300ml Contains:
Pharmaceutical ingredient (API) per unit Linezolid…..…600mg
Pharmaceutical form of applied drug Clear colorless liquid filled in glass vials
Pharmacotherapeutic Group of (API) Antibacterials for systemic use
Reference to Finished product Innovators specs
specifications
The status in reference regulatory Zyvox IV (USFDA Approved)
authorities
For generic drugs (me-too status) Nezkil Infusion by Continental pharma
Name and address of API manufacturer. Optrix Laboratories Pvt Ltd. Survey No. 145/A &
147, Ramalingampally (V), Bommalaramaram
(M), Yadadri-Bhuvanagiri District Telangana
India.
product.
(Conditions & duration of Stability batches of drug substance at both accelerated as
months.

stability.
Comparative Dissolution Profile equivalence for all the quality tests for their
product against Nezkil infusion of S.J & G Fazal
Elahi.
Analytical method validation/verification Firm has submitted verification studies of the
of product drug substance and the drug product.
Manufacturer of API Optrix Laboratories Pvt Ltd. Survey No. 145/A & 147,
Ramalingampally (V), Bommalaramaram (M), Yadadri-Bhuvanagiri
District Telangana India.
API Lot No. OT-LIU/06/2008
Description of Pack
Glass vials
Batch No. LZN001 LZN002 LZN003
Batch Size 500 Vials 500 Vials 500 Vials
No. of Batches 03
1. Reference of previous approval of Biogen Pharmaceutical is a new License facility
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate (No.
API manufacturer issued by concerned 68951/TS/2021) issued by Drugs control
regulatory authority of country of origin. administration, Government of Telangana dated
20-09-2021. The GMP certificate is valid till 19-
09-2022.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). dated 15-04-2020 specifying purchase of 3Kg
Linezolid.
Firm has submitted copy of DHL invoice number
00206995 dated 29-04-2020.
4. Data of stability batches will be supported Firm has submitted complete record of testing of
by attested respective documents like all batches along with raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
5. Compliance Record of HPLC software Not applicable. Our HPLC system are not 21 CFR
21CFR & audit trail reports on product compliant.
testing

6. Record of Digital data logger for Firm has submitted record of digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of real
stability chambers (real time and time and accelerated stability chambers.
accelerated)
Evaluation by PEC:

No
1. Specify the exact section in which the Firm has submitted that they will manufacture
applied drug will be manufactured, the applied product in Infusion section (General).
along with particulars of that section This section has the facility to fill glass vials from
including manufacturing facility 100ml to 300ml.
whether SVP or LVP and packaging
facility whether glass vials or LDPE
infusions.
2. Submit drug substance specifications Firm has submitted specifications of drug
in section 3.2.S.4.1 and secion substance from both API manufacturer as well as
3.2.S.4.2 from both drug substance Biogen Life Sciences.
manufacturer as well as drug product
manufacturer.
3. Submit data of verification of Firm has submitted report of verification studies
analytical procedure of drug substance of analytical procedure of drug substance.
4. Submit COA of relevant batch of drug Firm has submitted COA of relevant batch from
substance from API manufacturer as API manufacturer as well as Biogen Life
well as drug product manufacturer in Sciences.
section 3.2.S.4.4.
5. Justify why the qualitative Firm has submitted that their actual composition
composition of your formulation is which is also specified in BMR is as per the
different from that of innovator’s innovator’s product.
product. Provide drug-excipient
compatibility studies.
6. Justify why the pharmaceutical Firm has submitted that Nezkil infusion is the
equivalence studies were conducted commonly used comparator product in Pakistan
against the comparator product instead and they have also performed studies against that
of using innovator / reference product. product.
7. Justify why the product is not Firm has submitted copy of BMR which shows
subjected to terminal sterilization, terminal sterilization of the product at 121°C for
since this method is recommended by 30 minutes.
the innovator product.
8. You have mentioned innovator’s Firm has submitted relevant page of module 1
specifications in module-1 and in- which now specifies innovator’s product.
house specifications in module-3. However, the firm has not submitted fee for
Allign your drug product change in specifications in module 1.
specifications along with submission
of requisite fee.
9. Your pH limit is from 4.6 to 5.0, while It was a typo error the actual pH value was 4.76
you have passed the batch number
LZN001 having pH value 7.76.
Justification is required in this regard.
10. The container closure system of the Firm has submitted that their container closure
innovator is “flexible plastic infusion system is glass vial which is exactly simiar to that
bags in a foil laminate overwrap” of comparator product.
while your prduct is packed in glass
vial. Justify how your container

closure system can prevent the product
from exposure to the light.
11. Submit clear copy of commercial Firm has submitted copy of commercial invoice
invoice and evidence of import since dated 15-04-2020 specifying purchase of 3Kg
the submitted invoice is not properly Linezolid.
readable. Furthermore, also submit Firm has submitted copy of DHL invoice number
evidence of import of this material. 00206995 dated 29-04-2020.
Decision: Approved.
submission of applicable fee for pre-registration revision of specifications as per
Rawat, Rawalpindi
☐ Importer
giver)
2020.
facility letter dated 14-02-2020 which specifies Infusion
section (General).
☐ Export sale
The proposed proprietary name / brand MOXIGEN 400mg/250ml Solution for
name Infusion
Strength / concentration of drug of Active Each vial of 250ml Contains:
Pharmaceutical ingredient (API) per unit Moxifloxacin (as hydrochloride)……400mg
Pharmaceutical form of applied drug Sterile yellow liquid filled in glass vials
Pharmacotherapeutic Group of (API) Fluoroquinolone antibiotic
Reference to Finished product Innovators specs
specifications

The status in reference regulatory Avelox 400 mg/250 ml solution for infusion
authorities (MHRA Approved)
For generic drugs (me-too status) Avelox Injection by Bayer
Name and address of API manufacturer. Shree Je Laboatory Pvt. Ltd. C-24 & 25 RIICO
Industrial Area, Sotanala, Behror, District Alwar,
Rajasthan India.
product.
months.
stability.
product against Moxiget infusion of Getz
Pharma.

Manufacturer of API Shree Je Laboatory Pvt. Ltd. C-24 & 25 RIICO Industrial Area,
Sotanala, Behror, District Alwar, Rajasthan India.
API Lot No. MXYUSU001
Description of Pack
Glass vials
Batch No. T-001 T-002 T-003
No. of Batches 03
firm (if any)
API manufacturer issued by concerned 2019/203) issued by Drugs control Organization,
regulatory authority of country of origin. Government of Rajasthan India dated 07-02-2019.
The GMP certificate is valid upto three years from
the date of issue.
approval from DRAP (in case of import). dated 08-03-2021 specifying purchase of 2.5Kg
Moxifloxacin.
testing
accelerated)
Evaluation by PEC:

No
1. Specify the exact section in which the Firm has submitted that they will manufacture
applied drug will be manufactured, the applied product in Infusion section (General).
along with particulars of that section This section has the facility to fill glass vials from
including manufacturing facility 100ml to 300ml.
whether SVP or LVP and packaging

facility whether glass vials or LDPE
infusions.
2. You have submitted label claim “Each Firm has submitted revised label claim as
vial contains moxifloxacin follows:
hydrochloride 400mg/250ml” while Each vial of 250ml Contains:
the label claim of innovator product is Moxifloxacin (as hydrochloride)……400mg
“Each vial of 250ml Contains
Moxifloxacin (as hydrochloride)
400mg”. Revise your label claim along
with submission of fee for revision of
label claim.
3. Submit data of verification of Firm has submitted verification studies of
analytical procedure of drug substance analytical procedure of drug substance.
4. Submit stability study data of drug Firm has submitted stability study data as per
substance till claimed shelf life as per zone IV-A conditions where the real time data is
zone IV-A conditions, since the till 24 months.
submitted stability study data is till 1
year only.
5. Justify why the pharmaceutical Due to easy access of comparator product in the
equivalence studies were conducted market we have used it to perform comparative
against the comparator product instead studies.
of using innovator / reference product.
6. Justify why the product is not Firm has submitted copy of BMR which shows
subjected to terminal sterilization, terminal sterilization of the product at 121°C for
since this method is recommended by 30 minutes.
the innovator product.
7. You have mentioned innovator’s Firm has submitted relevant page of module 1
specifications in module-1 and in- which now specifies innovator’s product.
house specifications in module-3. However, the firm has not submitted fee for
Allign your drug product change in specifications in module 1.
specifications along with submission
of requisite fee.
8. The container closure system of the Firm has submitted that their container closure
innovator is “Polyolefine bags with system is glass vial which is exactly simiar to that
polypropylene port sealed in of comparator product.
aluminium foil overwrap” while your
prduct is packed in glass vial. Justify
how your container closure system can
prevent the product from exposure to
the light.
9. Submit clear copy of commercial Firm has submitted copy of commercial invoice
invoice and evidence of import since dated 08-03-2021 specifying purchase of 2.5Kg
the submitted invoice is not properly Moxifloxacin.
readable. Firm has also submitted copy of DHL invoice
number 270400305DTD.
Decision: Approved.
submission of pharmaceutical equivalence along with the innovator drug product.

submission of applicable fee for pre-registration revision of specifications as per
Capsule Section (General): 01 Molecules / 01 Products
Rawat, Rawalpindi
☐ Importer
giver)
2020.
facility letter dated 14-02-2020 which specifies Capsule
section (General).
☐ Export sale
The proposed proprietary name / brand TAMOGEN 0.4mg Capsule
name
Strength / concentration of drug of Active Each capsule Contains:
Pharmaceutical ingredient (API) per unit Tamsulosin hydrochloride (as sustained release
pellets)………0.4mg
Pharmaceutical form of applied drug White to off white spherical sustained release
pellets contained in hard gelatin capsule
Pharmacotherapeutic Group of (API) Alpha-adrenoreceptor antagonists
specifications
The status in reference regulatory Contiflo XL 400 micrograms capsules (MHRA
For generic drugs (me-too status) Tamsolin Capsule by Getz
Name and address of API manufacturer. Vision Pharmaceuticals, Plot No. 22-23,
Industrial Triangle Kahuta Road Islamabad.

product.
months.
stability.
product against Tamsol 0.4mg Capsule of Global
Pharmaceuticals.
Firm has submitted results of CDP for their
product against Tamsol 0.4mg Capsule of Global
Pharmaceuticals.
Manufacturer of API Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle Kahuta
Road Islamabad.
API Lot No. TMS303
Description of Pack
Alu-alu blister

Batch Size 1000 Capsule 1000 Capsule 1000 Capsule
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate issued
API manufacturer issued by concerned by Additional Director DRAP, Islamabad dated
regulatory authority of country of origin. 31-07-2019. The GMP certificate was granted
based on inspection dated 11-02-2019. The GMP
certificate is valid till 10-02-2022.
Tamsulosin HCL SR pellets.
testing
accelerated)
Evaluation by PEC:

No
1. Submit label claim in line with the Firm has submitted following label claim without
innovator product along withsubmission of fee:
submission of fee for revision of labelEach capsule Contains:
claim. Tamsulosin hydrochloride (as sustained release
pellets)………0.4mg
2. Submit drug substance specifications Firm has submitted drug substance specifications
in section 3.2.S.4.1 and secion from both API manufacturer as well as drug
3.2.S.4.2 from both drug substance product manufacturer.
manufacturer as well as drug product
manufacturer.
3. Submit data of verification of Firm has submitted verification studies of the
analytical procedure of drug substance analytical procedure of drug substance.

4. Justify why the pharmaceutical Due to easy access of comparator product in the
equivalence and comparative market we have used it to perform comparative
dissolution profile studies were studies.
conducted against the comparator
product instead of using innovator /
reference product.
5. The submitted HPLC chromatograms Firm has again submitted analytical record with
are not properly readable, resubmit clear readable prints.
clearly readable copies of the raw data.
6. Submit batch manufacturing record of Firm has submitted copy of Batch Manufacturing
three stability batches. Record of three stability batches.
Decision: Approved.
submission of pharmaceutical equivalence and Comparator Dissolution Profile (CDP)
along with the reference / comparator drug product.
submission of applicable fee for pre-registration revision of label claim as per
Case No. 02: M/s Nagarsons Pharmaceuticals, Islamabad
Firm has submitted copy of Acknowledgment of receipt of application for grant of DML by way
of formulation to M/s Nagarsons Pharmaceuticals dated 19-02-2021 from Secretary Central
Licensing Board. The letter specifies that CLB in its 278th meeting held on 10th and 11th
December 2020 has approved the grant of DML in the name of M/s Nagarsons Pharmaceuticals
for following sections:
1. Tablet (General)
2. Tablet (Psychotropic)
3. Capsule (General)
4. Cream /ointment/Lotion/Gel
Now the firm has submitted following applications as per the details mentioned in the table
below:
Name of Section Previously Newly applied Total

considered
No of No of No of No of No of No of
molecules products molecules products molecules products
Tablet (General) 02 03 02 04 04 07
Tablet - - - - - -
(Psychotropic)
Capsule (General) 06 10 - - - -
Cream - - - - - -
/ointment/Lotion/Gel
Tablet (General) section: 02 Molecules / 04 Products

177. Name, address of Applicant / M/s Nagarsons Pharmaceuticals. Plot No.
Marketing Authorization Holder 34, St. No. NS-2, National Industrial Zone,
Rawat, Islamabad
Name, address of Manufacturing site. M/s Nagarsons Pharmaceuticals. Plot No. 34,
St. No. NS-2, National Industrial Zone,
Rawat, Islamabad
☐ Importer
giver)
GMP status of the firm Firm has submitted copy of DML number
000927 issued dated 04-06-2021 with effect
from 19-02-2021.
facility of DML by way of formulation to M/s
Nagarsons Pharmaceuticals dated 07-06-
2021 for following sections:
1. Tablet (General)
☐ Export sale
The proposed proprietary name / brand TERBINAG 125mg Tablet
name
Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Terbinafine (as
hydrochloride)………125mg
Pharmaceutical form of applied drug white colored round uncoated tablet
Pharmacotherapeutic Group of (API) Antifungals for systemic use
specifications
The status in reference regulatory (MHRA Approved)
authorities
For generic drugs (me-too status) Lamisil Tablet 125mg of M/s Novartis (Reg
# 013208)
Name and address of API manufacturer. M/s Saptagir Laboratories Pvt Lt. Sy No.
Parts of 27, 46 & 50 to 56, Ananthasagar
(Vill) Chegunta (Mandal), Medak (Dist),
Telangana India.

product.
accelerated stability data is conducted at
40oC ± 2oC / 75% ± 5% RH for 6 months.
The real time stability data is conducted at
USP for their product against the reference
product i.e. Lamisil tablet of M/s Novartis
Pakistan.
Firm has submitted results of CDP in three
dissolution medium for their product against
the reference product i.e. Lamisil tablet of
M/s Novartis Pakistan.

Manufacturer of API M/s Saptagir Laboratories Pvt Lt. Sy No. Parts of 27, 46 & 50 to
56, Ananthasagar (Vill) Chegunta (Mandal), Medak (Dist),
Telangana India.
API Lot No. TH0180421
Description of Pack
Alu-Alu blister
Batch No. T-001 T-002 T-003
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED ALONG WITH STABILITY STUDY
DATA
1. Reference of previous approval of Nagarsons Pharmaceutical is a new license
applications with stability study data of the facility hence no such inspection has been
firm (if any) conducted.
API manufacturer issued by concerned (No. 54991/TS/2021) issued by Drugs
regulatory authority of country of origin. Control Administration Government of
Telangana. The certificate is valid till 01-03-
2022.
Terbinafine hydrochloride cleared dated 15-
09-2021. The invoice is cleared by AD (I&E).
4. Data of stability batches will be supported Firm has submitted complete record of
by attested respective documents like testing of all batches along with UV spectra,
chromatograms, Raw data sheets, COA, raw data sheets, COA and summary data
summary data sheets etc. sheets.
5. Compliance Record of HPLC software Not applicable. Our HPLC systems are not 21
21CFR & audit trail reports on product CFR compliant
testing
Evaluation by PEC:

No

1. Submit data in section 3.2.S.4.1 as Firm has submitted drug substance
per the guidance document approved specifications and analytical method from both
by Registration Board which API manufacturer as well as Nagarsons
specifies that “Copies of the Drug Pharma.
substance specifications and
analytical procedures used for
routine testing of the Drug substance
by both Drug substance & Drug
Product manufacturer is required.”
2. Submit verification studies of the Firm has submitted report of verification
analytical method of drug substance studies of the analytical method of drug
in section 3.2.S.4.3. substance.
3. Provide COA of relevant batch of Firm has submitted COA of relevant batch of
drug substance which is used in the drug substance from API manufacturer as well
manufacturing of batches of drug as Nagarsons Pharma.
product.
4. Provide detailed method of analysis Firm has submitted complete method of
by which pharmaceutical analysis for CDP and pharmaceutical
equivalence and CDP studies were equivalence which is in line with the drug
performed. product specifications of the firm.
5. Provide valid GMP certificate of the Firm has submitted copy of GMP certificate
drug substance manufacturer since (No. 54991/TS/2021) issued by Drugs Control
the submitted GMP certificate was Administration Government of Telangana. The
valid till 01-03-2022. certificate is valid till 01-03-2022.
6. Submit Batch Manufacturing Record Firm has submitted copy of Batch
of three stability batches. Manufacturing Record of three stability
batches.
Decision: Approved.
studies throughout proposed shelf life and on accelerated studies for six months as
per the commitment submitted in the registration application.
Rawat, Islamabad
Rawat, Islamabad
☐ Importer
giver)
from 19-02-2021.
1. Tablet (General)

☐ Export sale
The proposed proprietary name / brand TERBINAG 250mg Tablet
name
Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Terbinafine (as
hydrochloride)………250mg
Pharmaceutical form of applied drug white colored round uncoated tablet
Pharmacotherapeutic Group of (API) Antifungals for systemic use
specifications
The status in reference regulatory (MHRA Approved)
authorities
For generic drugs (me-too status) Lamisil Tablet 125mg of M/s Novartis (Reg
# 013209)
Name and address of API manufacturer. M/s Saptagir Laboratories Pvt Lt. Sy No.
Parts of 27, 46 & 50 to 56, Ananthasagar
(Vill) Chegunta (Mandal), Medak (Dist),
Telangana India.
product.

product i.e. Lamisil tablet of M/s Novartis
Pakistan.
the reference product i.e. Lamisil tablet of
M/s Novartis Pakistan.
Manufacturer of API M/s Saptagir Laboratories Pvt Lt. Sy No. Parts of 27, 46 & 50 to
56, Ananthasagar (Vill) Chegunta (Mandal), Medak (Dist),
Telangana India.
API Lot No. TH0180421
Description of Pack
Alu-Alu blister
Batch No. T-004 T-005 T-006

No. of Batches 03
DATA
API manufacturer issued by concerned (No. 54991/TS/2021) issued by Drugs
regulatory authority of country of origin. Control Administration Government of
Telangana. The certificate is valid till 01-03-
2022.
Terbinafine hydrochloride cleared dated 15-
09-2021. The invoice is cleared by AD (I&E).
testing
Evaluation by PEC:

No
product.
4. Provide detailed method of analysis Firm has submitted complete method of
by which pharmaceutical analysis for CDP and pharmaceutical
equivalence and CDP studies were equivalence which is in line with the drug
performed. product specifications of the firm.

5. Provide valid GMP certificate of the Firm has submitted copy of GMP certificate
drug substance manufacturer since (No. 54991/TS/2021) issued by Drugs Control
the submitted GMP certificate was Administration Government of Telangana. The
valid till 01-03-2022. certificate is valid till 01-03-2022.
batches.
Decision: Approved.
Rawat, Islamabad
Rawat, Islamabad
☐ Importer
giver)
from 19-02-2021.
1. Tablet (General)
☐ Export sale
The proposed proprietary name / brand AZONAG 250mg Capsule
name
Pharmaceutical ingredient (API) per unit Azithromycin (as dihydrate)………250mg
Pharmaceutical form of applied drug Hard gelatin capsule
Pharmacotherapeutic Group of (API) Macrolides

Reference to Finished product BP
specifications
The status in reference regulatory Zithromax Capsule of Pfizer (MHRA
For generic drugs (me-too status) Zithromax capsule 250mg of M/s Pfizer
Pakistan (Reg # 014471)
Name and address of API manufacturer. M/s Hebei Guolong Pharmaceutical Co. Ltd
No. 9 Xingye Street, Shijiazhuang Economic
and Technological Development Zone,
Hebei Province China.
product.

product i.e. Zetamax 250mg Capsule of M/s
Pfizer Pakistan.
the reference product i.e. Zetamax 250mg
Capsule of M/s Pfizer Pakistan.
Manufacturer of API M/s Hebei Guolong Pharmaceutical Co. Ltd No. 9 Xingye Street,
Shijiazhuang Economic and Technological Development Zone,
API Lot No. 210507019
Description of Pack
Alu-Alu blister
Batch No. T-001 T-0022 T-003
Batch Size 2500 Capsule 2500 Capsule 2500 Capsule
No. of Batches 03
DATA
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of Drug
API manufacturer issued by concerned Manufacturing License of Hebei Guolong
regulatory authority of country of origin. Pharmaceutical Co. Ltd. (No. JI20150058)
issued by Hebei Provincial Drug
Administration dated 22-07-2020. The
Azithromycin dihydrate cleared dated 24-08-
2021. The invoice is cleared by AD (I&E).

testing
Evaluation by PEC:

No
product.
4. Justify why pharmaceutical We use Zetamax Capsule by Pfizer because the
equivalence and CDP studies are innovator product is not available in the market
performed against zetamax capsule in Pakistan.
of Pfizer instead of using the
5. Provide raw data sheets for the Firm has submitted raw data sheets for the
calculation of results of dissolution calculation of results of dissolution test
test throughout the stability studies. throughout the stability studies using HPLC
method.
6. Submit analytical record for Firm has submitted that mistakenly at one time
azithromycin capsule since the point the data of azithromycin tablet was
submitted record contains HPLC attached instead of azithromycin capsule. Firm
chromatograms of azithromycin has now submitted analytical record for
tablet as well. azithromycin capsule.
batches.
Decision: Approved.

Rawat, Islamabad
Rawat, Islamabad
☐ Importer
giver)
from 19-02-2021.
1. Tablet (General)
☐ Export sale
The proposed proprietary name / brand AZONAG 250mg Tablet
name
Pharmaceutical form of applied drug White to off white film coated tablet
specifications
The status in reference regulatory (USFDA Approved)
authorities
For generic drugs (me-too status) Orzit Tablet 250mg of M/s Martin Dow (Reg
# 057294)

product.
product i.e. Zetamax 250mg Tablet of M/s
Pfizer Pakistan.
the reference product i.e. Zetamax 250mg
Tablet of M/s Pfizer Pakistan.

API Lot No. 210507019
Description of Pack
Alu-Alu blister
Batch No. T-004 T-005 T-006
No. of Batches 03
DATA
testing
Evaluation by PEC:

No

product.
4. Justify why pharmaceutical We use Zetamax tablet by Pfizer because the
equivalence and CDP studies are innovator product is not available in the market
performed against zetamax tablet of in Pakistan.
Pfizer instead of using the
calculation of results of dissolution
calculation of results of dissolution test
test throughout the stability studies.
throughout the stability studies using HPLC
method.
6. Provide evidence of column oven Firm has not submitted evidence of HPLC
which is required to maintain along with column oven.
temperature of 50°
batches.
Decision: Deferred for submission of evidence of HPLC system along with column oven
which is required to maintain temperature of 50° for assay testing of drug product as per
USP monograph.
Rawat, Islamabad
Rawat, Islamabad
☐ Importer
giver)
from 19-02-2021.

1. Tablet (General)
☐ Export sale
The proposed proprietary name / brand AZONAG 500mg Tablet
name
Pharmaceutical form of applied drug White to off white film coated tablet
specifications
authorities
For generic drugs (me-too status) Azomax Tablet 500mg of M/s Novartis
Pakistan (Reg # 045415)
product.

product i.e. Azomax 500mg Tablet of M/s
Novartis Pakistan.
the reference product i.e. Azomax 500mg
Tablet of M/s Novartis Pakistan.
API Lot No. 210507019
Description of Pack
Alu-Alu blister
Batch No. T-001 T-002 T-003

No. of Batches 03
DATA
testing
Evaluation by PEC:

No
product.
4. Submit stability study data in proper Firm has submitted complete data in section
sequence as per the guidelines of 3.2.P.8.3 as per the guidelines specified in
registration Board since the CTD guidance document.

submitted data is not properly
aligned.
calculation of results of dissolution calculation of results of dissolution test
test throughout the stability studies. throughout the stability studies using HPLC
method.
6. Provide evidence of column oven Firm has not submitted evidence of HPLC
which is required to maintain along with column oven.
temperature of 50°
batches.
Decision: Deferred for submission of evidence of HPLC system along with column oven
which is required to maintain temperature of 50° for assay testing of drug product as per
USP monograph.
M/s Martin Dow Limited, Plot No. 37, Sector 19, Korangi Industrial Area Karachi.
On the recommendations of panel of experts, the CLB in its 277th meeting held on 15th -16th
October has
considered and approved the following one additional section of M/s Martin Dow Limited,
Plot No. 37, Sector 19, Korangi Industrial Area, Karachi. The details of the products applied
and already considered against new section are as under:
Already considered Freshly applied

Molecule Product Molecule Product
03 05 01 01
Dry Powder Inhalers Section (General) (1 molecules / 1 Product)
182. Name, address of Applicant / M/s Martin Dow Limited, Plot No. 37,
Marketing Authorization Holder Sector 19, Korangi Industrial Area
Karachi.
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot No. 37, Sector
19, Korangi Industrial Area Karachi.
☐ Importer
giver)
GMP status of the firm GMP certificate issued based on the
inspection dated 7th May 2019.
Firm has also submitted copy of GMP
inspection report dated 20-10-2021 which
specifies that the firm is considered to be
operating at Good level of compliance with
cGMP guidelines.
Evidence of approval of manufacturing Firm has submitted copy of letter of Grant of
facility additional section dated 27-10-2020
specifying Dry powder Inhaler Capsule
(General) - New section.

☐ Export sale
The proposed proprietary name / brand INDIBRO-M 150/50/160 mcg DPI Capsule
name
Strength / concentration of drug of Active Each DPI Capsule Contains:
Pharmaceutical ingredient (API) per unit Indacaterol (as acetate)……150mcg
Glycopyrronium (as bromide)…50mcg
Mometasone Furoate…160mcg
Each delivered dose contains:

Indacaterol (as acetate)……114mcg
Glycopyrronium (as bromide)…46mcg
Mometasone Furoate…136mcg
Pharmaceutical form of applied drug Transparent cap and body, Hypromellose
capsule size No. 3 containing white to off
white powder
Pharmacotherapeutic Group of (API) Adrenergics in combination with
anticholinergics incl. triple combinations
with corticosteroids (ATC code: R03AL12)
specifications
Proposed Pack size 10’s, 30’s, 90’s
The status in reference regulatory Enerzair Breezhaler 114 micrograms/46
authorities micrograms/136 micrograms inhalation
powder, hard capsules of Novartis
Europharm Limited (EMA Approved)
Name and address of API manufacturer. Indacaterol acetate: Melody Healthcare
Pvt. Ltd.Plot No. J-73, M.I.D.C, Tarapur,
Boisar, Dist. Palghar 401506, Tal: MIDC
Tarapur boisar, Dist: Thane- Zone4.
Maharashtra State, India.
Glycopyrronium: INKE, S.A. C/Argent, 1.
Area Industrial del Llobregat 08755
CASTELLBISBAL (BARCELONA).
Mometasone Furoate: Aarti Industries
Limited
Plot No E-50, MIDC, Tarapur, Taluka &
District-Palghar, 401506 Maharashtra State,
India.

product.
Stability Studies of Drug Substance Indacaterol Acetate:
(Conditions & duration of Stability Real time: 30°C ± 2°C / 75% ± 5%RH for 24
studies) months
6 months
Batches: (ICA/01/21, ICA/02/21,
ICA/03/21)
Glycopyrronium Bromide:
months
6 months
Batches: (P-1M-1, P-2M-1, P-3M-1)
Mometasone Furoate:
months
6 months
Batches: (MF-13013 (JM-01)-001, MF-
13014 (JM-01)-001, MF-14305 (JM-01)-
001)
Pharmaceutical Equivalence and Pharmaceutical Equivalence and Invitro
Comparative Dissolution Profile Comparative Delivered Dose Uniformity and
Aerodynamic Particle Size distribution was
performed against Innovator Product Enezair
150/50/160mcg DPI capsule Batch no:
BUL36 manufactured by Novartis.

Manufacturer of API Indacaterol acetate: Melody Healthcare Pvt. Ltd.Plot No. J-73,
M.I.D.C, Tarapur, Boisar, Dist. Palghar 401506, Tal: MIDC
Tarapur boisar, Dist: Thane- Zone4. Maharashtra State, India.
Glycopyrronium: INKE, S.A. C/Argent, 1. Area Industrial del
Llobregat 08755 CASTELLBISBAL (BARCELONA).
Mometasone Furoate: Aarti Industries Limited
Plot No E-50, MIDC, Tarapur, Taluka & District-Palghar, 401506
Maharashtra State, India.
API Lot No. Indacaterol acetate: ICA/08/21
Glycopyrronium: P-21M
Mometasone Furoate: MF-20016(JM-01)-001
Description of Pack
Alu-alu blister
Batch No. NPD-C-1736-S NPD-C-1737-S NPD-C-1738-S
Batch Size 6000 capsules 6000 capsules 6000 capsules
No. of Batches 03
DATA
1. Reference of previous approval of Firm has referred to onsite inspection report
applications with stability study data of the of their product “Empator 10mg Tablets”
firm (if any) which was presented in 291st meeting of
Registration Board wherein the Board
decided to approve registration of this product
Date of inspection: 6th August, 2019.
According to inspection report, following
points were confirmed.
• The firm has 21CFR compliant HPLC
software.
• The firm has audit trail reports available.
2. Approval of API/ DML/GMP certificate of Indacaterol acetate: Firm has submitteded
API manufacturer issued by concerned copy of GMP certificate (No.
regulatory authority of country of origin. 91716/2020/11/31377) of M/s Melody
Healthcare Pvt. Ltd.Plot No. J-73, M.I.D.C,
Tarapur, Boisar, Dist. Palghar 401506,
Thane- Zone4. Maharashtra State, India
issued by Food & Drugs Administration
(Maharashtra State). The Certificate is valid
till 19-03-2023.

Glycopyrronium: Firm has submitted copy
of GMP certificate (No. NCF-
II/&1917/001/CAT) of M/s INKE, S.A.
C/Argent, 08755 CASTELLBISBAL Spain
issued by Competent Regional Authority.
Directorate of Regulation, Planning and
Sanitary Resources. Health Department.
Generalitat of Catalunya. The certificate is
present at Eudra GMP database and was
issued on the basis of inspection dated 08-04-
2019. The certificate is valid till 08-04-2023.
Mometasone Furoate: Firm has submitted
copy of GMP certificate (No.
92338/2020/11/32133) of M/s Aarti
Industries Limited Plot No E-50, MIDC,
Tarapur, Taluka & District-Palghar, 401506
Maharashtra State, India issued by FDA
Mahrashtra. The certificate is valid till 09-06-
2023.
3. Documents for the procurement of API with Indacaterol acetate: ICA/08/21: Firm has
approval from DRAP (in case of import). submitted copy of commercial invoice
cleared dated 30-08-2021 specifying import
of 40g Indacaterol acetate. The commercial
invoice is attested by AD (I&E) DRAP.
Glycopyrronium: P-21M:
Firm has submitted copy of commercial
invoice cleared dated 27-07-2021 specifying
import of 0.008Kg Glycopyrronium. The
commercial invoice is attested by AD (I&E)
DRAP.
Mometasone Furoate: MF-20016(JM-01)-
001: Firm has submitted copy of commercial
import of 0.040Kg mometasone furoate. The
commercial invoice is attested by AD (I&E)
DRAP.
by attested respective documents like testing of all batches along with
5. Compliance Record of HPLC software Firm has submitted audit trail record of
21CFR & audit trail reports on product product testing of HPLC for all test intervals.
testing
Evaluation by PEC:
Details of DPI device is

submission of applicable fee for revision of specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
• The firm will use DPI device Monodose Inhaler Manufactured by M/s Berry
Plastiape S.p.A.
Case No. 03 Registration applications of CTD cases
a. Routine cases of local manufacturing
183. Name, address of Applicant / M/s Carer Pharmaceuticals Plot # 27,

Marketing Authorization Holder Main Road, Rawat Industrial Estate
Rawat.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot
No. 204-205, Industrial Triangle Kahuta
Road Islamabad.
☐ Importer
☒ Is involved in none of the above (contract
giver)
Copy of agreement for contract
manufacturing of pharmaceutical products
between contract giver and acceptor dated
01-03-2021 is submitted.
GMP status of the firm Global pharmaceuticals: 11 & 24-10-2018:
On the basis of findings, panel unanimously
decided to recommend the issuance of GMP
certificate.
Evidence of approval of manufacturing Not submitted
facility
☐ Export sale

The proposed proprietary name / brand BRIAR 100mg/5ml suspension
name
Evaluation by PEC:
The applicant firm (M/s Carer Pharmaceuticals) dated 30-03-2022 (Dy No. 8297) has submitted
a new request for registration of their product on contract manufacturing from M/s Seraph
Pharmaceuticals along with submission of full fee.
The details of the newly submitted data are as follows:
DY No. 8298: 30-03-2022
New fee: 75,000/-: 07-03-2022
Name, address of Applicant / M/s Carer Pharmaceuticals Plot # 27, Main
Marketing Authorization Holder Road, Rawat Industrial Estate Rawat.
Name, address of Manufacturing site. M/s Seraph Pharmaceuticals Plot # 210, Industrial
Triangle Kahuta Road Islamabad.
☐ Importer
(Contract manufacturing agreement between both
firms dated 05-01-2022 is provided)
GMP status of the firm Seraph Pharmaceuticals: GMP certificate issued
on the basis of inspection conducted on 11/07/2019.
Evidence of approval of manufacturing Firm (M/s Seraph Pharmaceuticals) has submitted
facility copy of Issuance of DML letter dated 12-06-2017
specifying Dry Vial Cephalosporin section.
☐ Export sale
Dy. No. and date of submission Dy No. 8298: 30-03-2022
Details of fee submitted Rs. 75,000/-: 07-03-2022
The proposed proprietary name / brand BRIAR 100mg/5ml suspension
name
Strength / concentration of drug of Active Each 5ml of reconstituted suspension contains:
Pharmaceutical ingredient (API) per unit Cefixime (as trihydrate)……100mg
Pharmaceutical form of applied drug Amber colored glass bottle containing white to off
white powder for reconstitution volume 30ml (after
reconstitution)
Reference to Finished product USP specs
specifications
Proposed Pack size 30ml bottle
authorities
For generic drugs (me-too status) Tripsan 100mg/5ml dry suspension by Seraph
Pharmaceuticals

Name and address of API manufacturer. Saakh Pharma (Pvt) Ltd. C-7/1, North Western
Industrial Zone Port Qasim Karachi.
(Conditions & duration of Stability of API at accelerated and real time conditions. The
studies) real time stability data is conducted as per zone IV-
A conditions till 12 months.
Firm has also submitted process validation report
Pharmaceutical Equivalence and Firm has performed comparative analysis of their
Comparative Dissolution Profile developed formulation against the comparator
product i.e. “Cefspan Dry powder for suspension
100mg/5ml”. Firm has submitted results of
pharmaceutical equivalence for all the quality tests
for their product against the comparator product.
The analysis of all quality tests were performed
according to USP monograph. The results depicts
that the developed formulation is comparable to the
comparator product.
The firm has also performed compatibility studies
of the product with diluent i.e. purified (boiled and
cooled water). Firm has performed testing of assay
pH and other parameters for 7 days at room
temperature and 14 days at 2 – 8 oC and the results
after reconstitution were within the acceptable range
specified by the firm.
Analytical method validation/verification Firm has submitted report of validation of analytical
of product method for the drug product.

Firm has submitted report of verification studies of
analytical method for the drug substance.
Manufacturer of API Saakh Pharma (Pvt) Ltd. C-7/1, North Western Industrial Zone Port
Qasim Karachi.
API Lot No. 17CF10172
Description of Pack
1’s bottle of powder for suspension packed in unit carton
Batch No. 001 002 003
Batch Size 10,000 bottles 10,000 bottles 10,000 bottles
No. of Batches 03
DATA
1. Reference of previous approval of Firm has referred to following product
applications with stability study data of the specific inspection reports
firm (if any) • Dexpro (Dexlansoprazole) 30 and 60mg
Capsule. PSI was conducted on 11-09-2018
and the product was approved in 285th
meeting of Registration Board.
• Neovel 800mg Tablet. Its PSI was
conducted on 14-12-2018 and the product
was approved in 288th meeting of
Registration Board.
• Serbica 20mg Capsule. Its PSI was
conducted on 29-10-2018 and the product
was approved in 290th meeting of
Registration Board.
Firm has further submitted that their product
Neogene 2g Injection was approved in 293th
meeting of Registration Board. That product
was applied by AGP and contract
manufactured by Seraph and was submitted
on Form 5F (CTD) along with complete data.
2. Approval of API/ DML/GMP certificate of Copy of DML of M/s Saakh Pharma is
API manufacturer issued by concerned submitted by the firm.
regulatory authority of country of origin. Copy of GMP certificate of M/s Saakh
Pharma dated 15-01-2018 issued on the basis
of inspection dated 16-10-2017 is submitted
by the firm. The certificate is issued by
Additional Director DRAP Karachi.

3. Documents for the procurement of API with Firm has submitted copy of invoice dated 12-
approval from DRAP (in case of import). 01-2018 specifying purchase of 50Kg
cefixime from Saakh Pharma (Pvt) Ltd.
5. Compliance Record of HPLC software Firm has submitted that since the stability
21CFR & audit trail reports on product study of this product was initiated 2 years ago,
testing at that time our HPLC (Schimadzu) was not
21 CFR compliant. However now we have 21
CFR compliant (Perkin Elmer) HPLC system.
We undertake that in future we will use 21
CFR compliant HPLC system for stability
testing.
6. Record of Digital data logger for Firm has submitted that their stability
temperature and humidity monitoring of chambers are supplied with uninterrupted
stability chambers (real time and power supply and have digital data logger for
accelerated) monitoring temperature and humidity. The
digital data logger have been verified by the
panel during our onsite inspection as well.
Evaluation by PEC:
• The applied product to be manufactured by M/s Seraph Pharmaceuticals Plot # 210,

Industrial Triangle Kahuta Road Islamabad have already been approved by Registration
Board in its 297th meeting based on the data of same batches of drug product as submitted
in the instant case. The details of the already approved product in 297th meeting are as
follows:
Applicant firm M/s Moringa Pharmaceuticals 35-A, Sunder Industrial

Estate,
Lahore.
Manufacturer firm M/s Seraph Pharmaceuticals Plot # 210, Industrial
Brand Name Saf-Xime 100mg/5ml Dry suspension
Case No. 279
BR Meeting 297
Decision: Approved.
Manufacturer will perform process validation of first three batches as per the commitment
184. Name, address of Applicant / M/s Akson Pharmaceuticals Pvt Ltd. Plot
Marketing Authorization Holder no.9-B/1 & 2, Sector D-1, Old industrial
Estate Mirpur Azad Kashmir
Name, address of Manufacturing site. M/s Nicholas Pharmaceuticals, plot # 34, St
# SS-02 National industrial Zone Rawat
Islamabad

☐ Importer
giver)
GMP status of the firm Nicholas pharma: Firm has submitted copy
of GMP certificate dated 25-02-2020 issued
on the basis of inspection dated 28-01-2020
facility of DML No 000886 of M/s Nicholas Pharma
Islamabad dated 29-08-2018 specifying dry
powder injection (carbapenem) section.
☐ Export sale
The proposed proprietary name / brand MERNEM 500mg Injection
name
Pharmaceutical ingredient (API) per unit Meropenem trihydrate eq to
meropenem……500mg
Pharmaceutical form of applied drug White to off white powder filled in clear
glass vials
specifications
authorities
Name and address of API manufacturer. M/s Rajasthan Antibiotics Ltd. Plot No. 619
& 630 RIICO Industrial Area bhiwadi
District Alwar Rajasthan, India.

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
Comparative Dissolution Profile equivalence for the quality tests for their
product against Meronem500mg Injection of
Pfizer Pakistan Ltd manufactured by ACS
Dobfar Italy.
Manufacturer of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO
Industrial Area bhiwadi District Alwar Rajasthan, India.
Description of Pack
Glass vial


No. of Batches 03
DATA
1. Reference of previous approval of No previous inspection of the firm has been
applications with stability study data of the conducted for verification of stability study
firm (if any) data.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate of M/s Rajasthan
API manufacturer issued by concerned Antibiotics Ltd. Plot No. 619 & 630 RIICO
regulatory authority of country of origin. Industrial Area bhiwadi District Alwar
Rajasthan, India. (Certificate# DC/A-I/WHO-
GMP/2022/440) issued by Drug Control
Organization Government of Rajastan valid
approval from DRAP (in case of import). • Copy of Form 5 (License to Import) dated
30-04-2019
• Commercial invoice (invoice# RALIE/19-
20/003) Dated: 12-04-2019 cleared by
DRAP Islamabad office dated 30-04-2019
specifying import of 20Kg Meropenem
Sterile for Injection(Batch#
MRPS/062/18).
4. Data of stability batches will be supported Firm has submitted Stability data along-with
by attested respective documents like HPLC chromatograms and raw data sheets.
5. Compliance Record of HPLC software We have performed stability testing as per
21CFR & audit trail reports on product USP specifications. We have also verified the
testing USP method. The analysis was performed
using HPLC system which is 21 CFR
compliant. The certificate of compliance is
also submitted by the firm.
temperature and humidity monitoring of temperature and humidity monitoring of real
accelerated)
Evaluation by PEC:
• The applied product to be manufactured by M/s Nicholas Pharmaceuticals have already

been approved by Registration Board in its 307th and 316th meeting based on the data of
same batches of drug product as submitted in the instant case. The details of the already
approved product in 316th meeting are as follows:

Applicant firm M/s Jinnah Pharmaceutical (Pvt) Ltd. 13-Km, Lahore
Road Multan
Injection 001
Case No. 820
meeting
Capacity assessmnet The capacity assessment was carried on 18-05-2021 and
28-05-2021.
Available manufacturing Capacity (Cephalosporin
Injection) = 66.78%
Available manufacturing Capacity (Carbapenem
Injection) = 97.23%
Available capacity (HPLC) = 59.61%
Available Sterility testing capacity = 77.66%
The Board in its 307th meeting decided to allow contract
manufacturing from M/s Nicholas Phamrmaceuticals and
advised the firm to upgrade their QC and microbiological
lab includin gaddition of atleast 2 HPLC systems.
The firm vide its letter Dy. No. 5367 dated 08-03-2022
submitted the evidence of purchase of 02 new HPLC
systems. The firm also submitted evidence of purchase of
atomic absorption spectrophotometer for testing of
sodium content vide letter Dy.No. 6363 dated 08-03-
2022.
•
Decision: Approved.
185. Name, address of Applicant / M/s Akson Pharmaceuticals Pvt Ltd. Plot
Marketing Authorization Holder no.9-B/1 & 2, Sector D-1, Old industrial
Estate Mirpur Azad Kashmir
Islamabad
☐ Importer
giver)

☐ Export sale
The proposed proprietary name / brand MERNEM 1g Injection
name
meropenem……1g
Pharmaceutical form of applied drug White to off white powder filled in clear glass
vials
specifications
authorities
product.

40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
product against Meronem 1g Injection of
Dobfar Italy.
Description of Pack
Glass vial

No. of Batches 03
DATA
firm (if any) data.
30-04-2019
20/003) Dated: 12-04-2019 cleared by
Sterile for Injection(Batch# MRPS/062/18).
accelerated)
Evaluation by PEC:


Road Multan
Injection 001

Case No. 821
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•
Decision: Approved.
186. Name, address of Applicant / M/s Ameer & Adnan Pharmaceutical Pvt
Marketing Authorization Holder Ltd.
Plot No.47, Sundar Industrial Estate,
Lahore
Islamabad
☐ Importer
giver)

☐ Export sale
The proposed proprietary name / brand MERNEM 500mg Injection
name
vials
specifications
authorities
product.

40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
Dobfar Italy.
Description of Pack
Glass vial
No. of Batches 03
DATA
firm (if any) data.

30-04-2019
20/003) Dated: 12-04-2019 cleared by
accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 820
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%

2022.
•
Decision: Approved.
187. Name, address of Applicant / M/s Ameer & Adnan Pharmaceutical Pvt
Marketing Authorization Holder Ltd.
Plot No.47, Sundar Industrial Estate,
Lahore
Islamabad
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand MERNEM 1g Injection
name
meropenem……1g

vials
specifications
authorities
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.

Dobfar Italy.
Description of Pack
Glass vial
No. of Batches 03
DATA
firm (if any) data.
30-04-2019
20/003) Dated: 12-04-2019 cleared by

21CFR & audit trail reports on productUSP specifications. We have also verified the
accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 821
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•

Decision: Approved.
188. Name, address of Applicant / M/s Athan Pharmaceuticals. Plot 84/1,
Marketing Authorization Holder Block B, Phase 5, Industrial Estate, Hattar
Islamabad
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand CARBANEM 500mg Injection
name
vials
specifications
authorities

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
Dobfar Italy.

Description of Pack
Glass vial
No. of Batches 03
DATA
firm (if any) data.
30-04-2019
20/003) Dated: 12-04-2019 cleared by

accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 820
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•
Decision: Approved.
189. Name, address of Applicant / M/s Athan Pharmaceuticals. Plot 84/1,
Marketing Authorization Holder Block B, Phase 5, Industrial Estate, Hattar
Islamabad

☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand CARBANEM 1g Injection
name
meropenem……1g
vials
specifications
authorities

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
Dobfar Italy.
Description of Pack
Glass vial


No. of Batches 03
DATA
firm (if any) data.
30-04-2019
20/003) Dated: 12-04-2019 cleared by
accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 821
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•
Decision: Approved.
190. Name, address of Applicant / M/s Aulton Pharmaceuticals. Plot No.
Marketing Authorization Holder 84/1, Block A, Phase V, Industrial Estate,
Hattar
Islamabad
☐ Importer
giver)

☐ Export sale
The proposed proprietary name / brand AROPEN 500mg Injection
name
vials
specifications
authorities
product.

40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
Dobfar Italy.
Description of Pack
Glass vial
No. of Batches 03
DATA

conducted for verification of stability study
firm (if any) data.
regulatory authority of country of origin.Industrial Area bhiwadi District Alwar
30-04-2019
20/003) Dated: 12-04-2019 cleared by
accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 820
meeting

28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•
Decision: Approved.
191. Name, address of Applicant / M/s Aulton Pharmaceuticals. Plot No.
Marketing Authorization Holder 84/1, Block A, Phase V, Industrial Estate,
Hattar
Islamabad
☐ Importer
giver)
☐ Export sale

The proposed proprietary name / brand AROPEN 1g Injection
name
meropenem……1g
vials
specifications
authorities
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.

Dobfar Italy.
Description of Pack
Glass vial
No. of Batches 03
DATA
firm (if any) data.

30-04-2019
20/003) Dated: 12-04-2019 cleared by
accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 821
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%

2022.
•
Decision: Approved.
192. Name, address of Applicant / M/s Newton Health care Pvt Ltd.
Marketing Authorization Holder Plot No. 8,9. H.I.T.E, Hub Balochistan
Islamabad
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand ENIM 500mg Injection
name
vials

specifications
authorities
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.

Dobfar Italy.
Description of Pack
Glass vial
No. of Batches 03
DATA
firm (if any) data.
30-04-2019
20/003) Dated: 12-04-2019 cleared by

accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 820
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•
Decision: Approved.

193. Name, address of Applicant / M/s Newton Health care Pvt Ltd.
Marketing Authorization Holder Plot No. 8,9. H.I.T.E, Hub Balochistan
Islamabad
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand ENIM 1g Injection
name
meropenem……1g
vials
specifications
authorities

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 75 ± 5% RH for 36 months.
Dobfar Italy.

Description of Pack
Glass vial
No. of Batches 03
DATA
firm (if any) data.
30-04-2019
20/003) Dated: 12-04-2019 cleared by

accelerated)
Evaluation by PEC:


Road Multan
Injection 001
Case No. 821
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
•
Decision: Approved.
194. Name, address of Applicant / M/s Linta Pharmaceuticals (Pvt) Ltd. Plot
Marketing Authorization Holder # 3, Street S-5, National Industrial Zone,
Rawat Islamabad.
Name, address of Manufacturing site. M/s Rotex Pharma (Pvt) Ltd, Plot # 206 &
207, Industrial Triangle Kahuta Road
Islamabad.

☐ Importer
giver)
Original agreement for contract
GMP status of the firm Linta Pharmaceuticals: The firm was
inspected on 10-07-2019 and conclusion of
inspection was: Keeping in view the above it
may be concluded that M/s Linta
Pharmaceuticals is operating at acceptable
level of GMP standard.
Rotex pharma: GMP certificate issued on
the basis of inspection dated 12-08-2020
facility additional section / amendment under DML
No 000651 of M/s Rotex Pharma Islamabad
dated 13-06-2017 specifying dry powder
injection (carbapenem) section.
☐ Export sale
The proposed proprietary name / brand PENAM 500mg Injection
name
vials with dark blue flip off seal.
specifications
authorities
Name and address of API manufacturer. M/s Sterile India Pvt Ltd. Plot No. 100& 118-
G, Phase-IV, Sector-56, HSIIDC, Industrial
Estate Kundli District Sonepat Haryana
India.

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.
product against Meronem 500mg Injection of
Dobfar Italy.
Manufacturer of API M/s Sterile India Pvt Ltd. Plot No. 100& 118-G, Phase-IV, Sector-
56, HSIIDC, Industrial Estate Kundli District Sonepat Haryana
India.

API Lot No.
Description of Pack
Glass vial
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Batch No. C160001 C160002 C160003
No. of Batches 03
DATA
1. Reference of previous approval of Not submitted
firm (if any)
API manufacturer issued by concerned Not submitted
3. Documents for the procurement of API with Not submitted
4. Data of stability batches will be supported Not submitted
5. Compliance Record of HPLC software Not submitted
testing
Evaluation by PEC:
• The status of applicant mentioned in section 1.3.3 of module 1 is “manufacturer” while
the application is for contract manufacturing from Rotex Pharma. Clarification is required
in this regard.
• Submit module 1 as per the CTD guidance document approved by Registration Board by
providing all the information and documents in relevant sections / sub-sections instead
of referring to annexures.
• Provide details regarding total number of sections and number of products already
registered and applied on contract manufacturing of M/s Linta Pharmaceuticals.
• Submit quality overall summary (QOS) in module 2 as per WHO QOS-PD template or
as per the template approved by Registration Board in its 296th meeting and also
published in CTD guidance document. The submitted QOS contains extracts from
module 3 instead of providing summary of the data as per the requirements of QOS.

• Provide data in section 3.2.S.3.1 as per the guidance document approved by Registration
Board which specifies that “Discussion on the potential for isomerism and identification
of stereochemistry, studies performed to identify potential polymorphic forms and
particle size distribution of the Drug substance shall be submitted, where these
parameters may impact the quality, safety or efficacy of the drug product.”
• Section 3.2.S.4.1 contains specifications for meropenem trihydrate sterile, sodium
carbonate sterile and meropenem for injection. Clarification is required that which
particular specifications was used for the testing of drug substance.
• Submit data in section 3.2.S.4.1 as per the guidance document approved by Registration
Board which specifies that “Copies of the Drug substance specifications and analytical
procedures used for routine testing of the Drug substance /Active Pharmaceutical
Ingredient by both Drug substance & Drug Product manufacturer is required.”
• Justify the acceptance criteria of assay “NLT 78% as meropenem on dried basis”, and
also provide scientific justification how it is in line with the USP monograph.
• Specify the relative retention time in terms of quantitative values for the identification of
drug substance, since the statement “the retention time of meropenem peak of the sample
solution correspond to that of the standard solution obtained in assay” is not scientifically
justified without having a relative retention time limit.
• As per the assay method of drug substance, the sample solution is nominally 0.1mg/ml
of meropenem in mobile phase. While as per USP monograph the sample solution
preparation method is entirely different which involves initial reconstitution with water
prior to dilution with mobile phase. Justify how the tests performed by your method can
be considered acceptable under the USP monograph.
Board which specifies that “Analytical Method Verification studies including specificity,
accuracy and repeatability (method precision) performed by the Drug Product
manufacturer for both compendial as well as non-compendial drug substance(s) shall be
submitted.
Board which specifies that “Provide results of analysis of relevant batch(es) of Drug
Substance performed by Drug Product manufacturer used during product development
and stability studies, along with Certificate of Analysis (CoA) of the same batch from
Drug Substance / /Active Pharmaceutical Ingredient manufacture. A discussion and
justification shall be provided for any incomplete analyses of the drug substance / API
by Drug Product manufacturer (e.g. results not tested according to the proposed
specification)”.
• Provide COA of reference standard / working standard used in the testing of drug
substance.
• Justify how 710mg of meropenem as trihydrate blended with sodium carbonate contains
500mg of meropenem.
• Submit information in section 3.2.P.1 c) Description of accompanying reconstitution
diluent(s) as per the guidance document approved by Registration Board which specifies
that “Provide information including type of diluent, its composition, quantity or volume,
specifications (as applicable) and regulatory status in Pakistan (as applicable) for the
diluent which is to be provided along with the applied drug”.
• Submit information in section 3.2.P.2 as per the guidance document approved by
Registration Board which specifies that “A brief information on the pharmaceutical
development shall be included. This information specify the justification of formulation
and method of manufacturing. It is also important that critical quality attributes (CQAs)
and Critical Process Parameters (CPP) shall be discussed”.
• Submit data in section 3.2.P.2.1.1 as per the guidance document approved by Registration
Board which specifies that “Discussion shall be provided for the key physicochemical
characteristics (e.g. water content, solubility, particle size distribution, polymorphic or

solid state form) of the Drug Substance(s) that can influence the performance of the Drug
Product”.
• Provide details including batch number, expiry date of the innovator product along with
pharmaceutical equivalence was performed.
• You have submitted that 20ml reconstituted volume is available with Meronem 500mg
Injection of Pfizer Pakistan, however the meropenem 500mg injection of innovator as
well as reference product is reconstituted using 10ml diluent. Clarification is required in
this regard.
• Submit data in section 3.2.P.2.6 as per the guidance document approved by Registration
Board which specifies that “Compatibility studies for the dry powder for injections and
dry powder for suspension shall be performed as per the instructions provided in
individual label of the drug product”.
• Specify the volume of the vial of the drug product, since 30ml vial was mentioned in
section 3.2.P.2 while 20ml vial is mentioned in section 3.2.P.3.
• Specify the colour of seal, since blue colour is mentioned in section 3.2.P.2 while green
colour is mentioned in section 3.2.P.3.
• Provide detailed method of sample solution preparation for assay testing of the drug
product in section 3.2.P.5.2 specifying the exact volume of water in which reconstitution
is carried out.
• Justify why the formula for calculation of assay results of meropenem submitted in
section 3.2.P.5.2 is different from that specified in USP monograph.
• Justify why the test of contents of sodium is not included in the specifications of the drug
product as per the USP monograph.
• Justify how the 3 batches were released without determining the contents of sodium.
• Submit COA of reference standard / working standard used for the testing of the stability
batches in section 3.2.P.6.
Board which specifies that “Summary of additional stability studies (if applicable) e.g.
in-use studies for drug products which are to be reconstituted before use, along with
proposed in-use storage statement and in-use shelf-life shall be provided”.
• Justify why the test of identification, contents of sodium, constituted solution, loss on
drying is not performed during the stability studies.
• Justify why test of bacterial endotoxin and sterility was not performed at 6 month time
point at accelerated stability studies.
• Justify why only 3 chromatographs of the standard solution was run while USP General
chapter <621> recommends that five replicates of standard solution should be used for
system suitability studies.
• Submit raw data sheets to support the calculation of results of assay throughout the
stability studies.
• Provide analytical record including certificate of analysis at each time point, HPLC
chromatograms, raw data sheets using page separators to segregate the data of each time
point and each batch, since the submitted data is mixed up and submitted without any
sequence.
• Submit stability study data in section 3.2.P.8.3 as per the checklist approved by
Registration Board in its 296th meeting and the CTD guidance document, which includes
the following:
o Reference of previous approval of applications with stability study data of the
firm (if any)
o Approval of API/ DML/GMP certificate of API manufacturer issued by
concerned regulatory authority of country of origin.
o Documents for the procurement of API with approval from DRAP (in case of
import).
o Data of stability batches will be supported by attested respective documents like
chromatograms, Raw data sheets, COA, summary data sheets etc.

o Compliance Record of HPLC software 21CFR & audit trail reports on product
testing
o Record of Digital data logger for temperature and humidity monitoring of stability
• Submit Batch Manufacturing record (BMR) of the three batches for which stability study
data is submitted.
Response by the firm:
Firm vide its letter dated 19-08-2021 submitted that they request to change the contract
manufacturer to M/s Nicholas Pharmaceuticals, Islamabad. Firm has submitted following
documents:
• Complete fee for change of contract manufacturer 75,000/- vide slip number 265253322.
• Complete data in module 1, 2 and 3. The evaluation of the data is placed below
Name, address of Applicant / M/s Linta Pharmaceuticals (Pvt) Ltd. Plot # 3, Street
Marketing Authorization Holder S-5, National Industrial Zone, Rawat Islamabad.
National
industrial Zone Rawat Islamabad
☐ Importer
Evidence of approval of Firm has submitted copy of letter of issuance of DML
manufacturing facility No 000886 of M/s Nicholas Pharma Islamabad dated
Proposed proprietary name/brand PENAM 500mg Injection
name
Strength/concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Meropenem trihydrate eq to meropenem……500mg
(API) per unit (blended with sodium carbonate)
specifications

Status in reference regulatory Merrem Injection (USFDA Approved)
authorities
Name and address of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630
manufacturer. RIICO Industrial Area bhiwadi District Alwar
Rajasthan, India.
(Conditions & duration of Stability drug substance at both accelerated as well as real time
for 36 months.
Comparative Dissolution Profile equivalence for the quality tests for their product against
Meronem500mg Injection of Pfizer Pakistan Ltd
Manufacturer of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial
Area bhiwadi District Alwar Rajasthan, India.
Description of Pack Glass vial

(Container closure
system)
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
No. of Batches 03
DATA
applications with stability study data of conducted for verification of stability study data.
the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP certificate of M/s Rajasthan
certificate of API manufacturer issued Antibiotics Ltd. Plot No. 619 & 630 RIICO
by concerned regulatory authority of Industrial Area bhiwadi District Alwar Rajasthan,
country of origin. India. (Certificate# DC/A-I/WHO-GMP/2020/214)
issued by Drug Control Organization Government
of Rajastan valid upto 26-02-2022 is submitted
3. Documents for the procurement of API Firm has submitted following:
with approval from DRAP (in case of • Copy of Form 5 (License to Import) dated 30-04-
import). 2019
20/003) Dated: 12-04-2019 cleared by DRAP
Islamabad office dated 30-04-2019 specifying
import of 20Kg Meropenem Sterile for
Injection(Batch# MRPS/062/18).
4. Data of stability batches will be Firm has submitted Stability data along-with
supported by attested respective HPLC chromatograms and raw data sheets.
etc.
21CFR & audit trail reports on product specifications. We have also verified the USP
testing method. The analysis was performed using HPLC
system which is 21 CFR compliant. The certificate
of compliance is as also submitted by the firm.
accelerated)
Evaluation by PEC:

Road Multan
Injection 001
Case No. 820
meeting
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
Decision: Approved.
195. Name, address of Applicant / M/s Linta Pharmaceuticals (Pvt) Ltd. Plot
Marketing Authorization Holder # 3, Street S-5, National Industrial Zone,
Rawat Islamabad.
Name, address of Manufacturing site. M/s Rotex Pharma (Pvt) Ltd, Plot # 206 &
207, Industrial Triangle Kahuta Road
Islamabad.
☐ Importer
giver)
Original agreement for contract
GMP status of the firm Linta Pharmaceuticals: The firm was
inspected on 10-07-2019 and conclusion of

inspection was: Keeping in view the above it
may be concluded that M/s Linta
Pharmaceuticals is operating at acceptable
level of GMP standard.
Rotex pharma: GMP certificate issued on
the basis of inspection dated 12-08-2020
No 000651 of M/s Rotex Pharma Islamabad
dated 13-06-2017 specifying dry powder
injection (carbapenem) section.
☐ Export sale
The proposed proprietary name / brand PENAM 1g Injection
name
meropenem……1g
vials with dark blue flip off seal
specifications
authorities
India.

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.
Dobfar Italy.
India.
API Lot No.
Description of Pack
Glass vial

Batch No. C161001 C161002 C161003
No. of Batches 03
DATA
firm (if any)
API manufacturer issued by concerned Not submitted
testing
Evaluation by PEC:
• The status of applicant mentioned in section 1.3.3 of module 1 is “manufacturer” while

the application is for contract manufacturing from Rotex Pharma. Clarification is required
in this regard.
• Submit module 1 as per the CTD guidance document approved by Registration Board by
providing all the information and documents in relevant sections / sub-sections instead
of referring to annexures.
• Provide details regarding total number of sections and number of products already
registered and applied on contract manufacturing of M/s Linta Pharmaceuticals.
• Submit quality overall summary (QOS) in module 2 as per WHO QOS-PD template or
as per the template approved by Registration Board in its 296th meeting and also
published in CTD guidance document. The submitted QOS contains extracts from
module 3 instead of providing summary of the data as per the requirements of QOS.
• Provide data in section 3.2.S.3.1 as per the guidance document approved by Registration
Board which specifies that “Discussion on the potential for isomerism and identification
of stereochemistry, studies performed to identify potential polymorphic forms and
particle size distribution of the Drug substance shall be submitted, where these
parameters may impact the quality, safety or efficacy of the drug product.”
• Section 3.2.S.4.1 contains specifications for meropenem trihydrate sterile, sodium
carbonate sterile and meropenem for injection. Clarification is required that which
particular specifications was used for the testing of drug substance.
Board which specifies that “Copies of the Drug substance specifications and analytical

procedures used for routine testing of the Drug substance /Active Pharmaceutical
Ingredient by both Drug substance & Drug Product manufacturer is required.”
• Justify the acceptance criteria of assay “NLT 78% as meropenem on dried basis”, and
also provide scientific justification how it is in line with the USP monograph.
• Specify the relative retention time in terms of quantitative values for the identification of
drug substance, since the statement “the retention time of meropenem peak of the sample
solution correspond to that of the standard solution obtained in assay” is not scientifically
justified without having a relative retention time limit.
• As per the assay method of drug substance, the sample solution is nominally 0.1mg/ml
of meropenem in mobile phase. While as per USP monograph the sample solution
preparation method is entirely different which involves initial reconstitution with water
prior to dilution with mobile phase. Justify how the tests performed by your method can
be considered acceptable under the USP monograph.
Board which specifies that “Analytical Method Verification studies including specificity,
accuracy and repeatability (method precision) performed by the Drug Product
manufacturer for both compendial as well as non-compendial drug substance(s) shall be
submitted.
Board which specifies that “Provide results of analysis of relevant batch(es) of Drug
Substance performed by Drug Product manufacturer used during product development
and stability studies, along with Certificate of Analysis (CoA) of the same batch from
Drug Substance / /Active Pharmaceutical Ingredient manufacture. A discussion and
justification shall be provided for any incomplete analyses of the drug substance / API
by Drug Product manufacturer (e.g. results not tested according to the proposed
specification)”.
• Provide COA of reference standard / working standard used in the testing of drug
substance.
• Justify how 1420mg of meropenem as trihydrate blended with sodium carbonate contains
1000mg of meropenem.
• Submit information in section 3.2.P.1 c) Description of accompanying reconstitution
diluent(s) as per the guidance document approved by Registration Board which specifies
that “Provide information including type of diluent, its composition, quantity or volume,
specifications (as applicable) and regulatory status in Pakistan (as applicable) for the
diluent which is to be provided along with the applied drug”.
• Submit information in section 3.2.P.2 as per the guidance document approved by
Registration Board which specifies that “A brief information on the pharmaceutical
development shall be included. This information specify the justification of formulation
and method of manufacturing. It is also important that critical quality attributes (CQAs)
and Critical Process Parameters (CPP) shall be discussed”.
• Submit data in section 3.2.P.2.1.1 as per the guidance document approved by Registration
Board which specifies that “Discussion shall be provided for the key physicochemical
characteristics (e.g. water content, solubility, particle size distribution, polymorphic or
solid state form) of the Drug Substance(s) that can influence the performance of the Drug
Product”.
• Provide details including batch number, expiry date of the innovator product along with
pharmaceutical equivalence was performed.
• You have submitted that 30ml reconstituted volume is available with Meronem 1g
Injection of Pfizer Pakistan, however the meropenem 1g injection of innovator as well as
reference product is reconstituted using 20ml diluent. Clarification is required in this
regard.
Board which specifies that “Compatibility studies for the dry powder for injections and

dry powder for suspension shall be performed as per the instructions provided in
individual label of the drug product”.
• Specify the volume of the vial of the drug product, since 50ml vial was mentioned in
section 3.2.P.2 while 30ml vial is mentioned in section 3.2.P.3.
• Specify the colour of seal, since blue colour is mentioned in section 3.2.P.2 while green
colour is mentioned in section 3.2.P.3.
• Provide detailed method of sample solution preparation for assay testing of the drug
product in section 3.2.P.5.2 specifying the exact volume of water in which reconstitution
is carried out.
• Justify why the formula for calculation of assay results of meropenem submitted in
section 3.2.P.5.2 is different from that specified in USP monograph.
• Justify why the test of contents of sodium is not included in the specifications of the drug
product as per the USP monograph.
• Justify how the 3 batches were released without determining the contents of sodium.
• Submit COA of reference standard / working standard used for the testing of the stability
batches in section 3.2.P.6.
Board which specifies that “Summary of additional stability studies (if applicable) e.g.
in-use studies for drug products which are to be reconstituted before use, along with
proposed in-use storage statement and in-use shelf-life shall be provided”.
• Justify why the test of identification, contents of sodium, constituted solution, loss on
drying is not performed during the stability studies.
• Justify why test of bacterial endotoxin and sterility was not performed at 6 month time
point at accelerated stability studies.
• Justify why only 3 chromatographs of the standard solution was run while USP General
chapter <621> recommends that five replicates of standard solution should be used for
system suitability studies.
• Submit raw data sheets to support the calculation of results of assay throughout the
stability studies.
• Provide analytical record including certificate of analysis at each time point, HPLC
chromatograms, raw data sheets using page separators to segregate the data of each time
point and each batch, since the submitted data is mixed up and submitted without any
sequence.
• Submit stability study data in section 3.2.P.8.3 as per the checklist approved by
Registration Board in its 296th meeting and the CTD guidance document, which includes
the following:
o Reference of previous approval of applications with stability study data of the
firm (if any)
o Approval of API/ DML/GMP certificate of API manufacturer issued by
concerned regulatory authority of country of origin.
o Documents for the procurement of API with approval from DRAP (in case of
import).
o Data of stability batches will be supported by attested respective documents like
chromatograms, Raw data sheets, COA, summary data sheets etc.
o Compliance Record of HPLC software 21CFR & audit trail reports on product
testing
o Record of Digital data logger for temperature and humidity monitoring of stability
• Submit Batch Manufacturing record (BMR) of the three batches for which stability study
data is submitted.
Firm vide its letter dated 19-08-2021 submitted that they request to change the contract
manufacturer to M/s Nicholas Pharmaceuticals, Islamabad. Firm has submitted following
documents:

• Complete fee for change of contract manufacturer 75,000/- vide slip number 265253322.
• Complete data in module 1, 2 and 3. The evaluation of the data is placed below
Name, address of Applicant / M/s Linta Pharmaceuticals (Pvt) Ltd. Plot # 3, Street
Marketing Authorization Holder S-5, National Industrial Zone, Rawat Islamabad.
Name, address of Manufacturing M/s Nicholas Pharmaceuticals, plot # 34, St # SS-02
site. National
industrial Zone Rawat Islamabad
☐ Importer
Evidence of approval of Firm has submitted copy of letter of issuance of DML No
manufacturing facility 000886 of M/s Nicholas Pharma Islamabad dated 29-08-
2018 specifying dry powder injection (carbapenem)
section.
Proposed proprietary name/brand PENAM 1g Injection
name
Strength/concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Meropenem trihydrate eq to meropenem……1g
(API) per unit (blended with sodium carbonate)
specifications
authorities
Name and address of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630
manufacturer. RIICO Industrial Area bhiwadi District Alwar Rajasthan,
India.

reference standard, container closure system and stability
studies of drug substance and drug product.
reference standard, container closure system and stability
for 36 months.
procedures, validation of analytical procedures, batch
stability.
Comparative Dissolution Profile equivalence for the quality tests for their product against
Meronem 1g Injection of Pfizer Pakistan Ltd
Manufacturer of API M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial
Area bhiwadi District Alwar Rajasthan, India.
Description of Pack
system)

No. of Batches 03
DATA
applications with stability study data of conducted for verification of stability study data.
the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP certificate of M/s Rajasthan
certificate of API manufacturer issued Antibiotics Ltd. Plot No. 619 & 630 RIICO
by concerned regulatory authority of Industrial Area bhiwadi District Alwar Rajasthan,
country of origin. India. (Certificate# DC/A-I/WHO-GMP/2020/214)
issued by Drug Control Organization Government
of Rajastan valid upto 26-02-2022 is submitted
3. Documents for the procurement of API Firm has submitted following:
with approval from DRAP (in case of • Copy of Form 5 (License to Import) dated 30-04-
import). 2019
20/003) Dated: 12-04-2019 cleared by DRAP
Islamabad office dated 30-04-2019 specifying
import of 20Kg Meropenem Sterile for Injection
(Batch# MRPS/062/18).
4. Data of stability batches will be Firm has submitted Stability data along-with
supported by attested respective HPLC chromatograms and raw data sheets.
etc.
21CFR & audit trail reports on product specifications. We have also verified the USP
testing method. The analysis was performed using HPLC
system which is 21 CFR compliant. The certificate
of compliance is as also submitted by the firm.
accelerated)
Evaluation by PEC:

Road Multan
Injection 001

Case No. 821
meeting
Capacity assessment The capacity assessment was carried on 18-05-2021 and
28-05-2021.
Injection) = 66.78%
Injection) = 97.23%
2022.
Decision: Approved.
196. Name, address of Applicant / M/s Horizon Healthcare (Pvt) Ltd. Plot
Marketing Authorization Holder No. 33, Sundar Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s English Pharmaceutical Industries Link
Kattar Bund Road, Thokar Niaz Baig,
☐ Importer
giver)
Firm has submitted copy of contract
manufacturing agreement with applicant
firm dated 28-05-2021.
GMP status of the firm English Pharmaceutical: GMP certificate
issued based on inspection dated 06-01-2018
Evidence of approval of manufacturing Firm (M/s English Pharmaceuticals) has
facility submitted copy of renewal of DML letter
dated 09-03-2015 specifying Dry powder
injectable vial (General) section.
☐ Export sale

Details of fee submitted Rs. 75,000/- Dated 02-07-2021
The proposed proprietary name / brand COLIZONE 1MIU Injection
name
Pharmaceutical ingredient (API) per unit Colistimethate sodium …… 1MIU
Pharmaceutical form of applied drug Powder for solution for injection
specifications
Proposed Pack size 1x1’s
The status in reference regulatory Colistimethate Sodium 1 Million I.U.
authorities Powder for Solution for Injection MHRA
Approved
For generic drugs (me-too status) Colitec 1MIU Injection by Rotex Pharma
(Reg # 092316)
Name and address of API manufacturer. M/s Hebei Shengxue Dacheng
Pharmaceutical Co Ltd. No. 50 Shengxue
Road Launcheng District Shijiazhuang
Hebei Province, China
product.
Module-III Drug Substance: Firm has submitted detailed drug substance
general properties, solubilities, physical
Stability Studies of Drug Substance Firm has submitted stability data of 3 batches
(Conditions & duration of Stability of API at accelerated and real time
studies) conditions.

Pharmaceutical Equivalence and Firm has submitted pharmaceutical
Comparative Dissolution Profile equivalence of their product against the
comparator product Colixin Injection of
Pharmis Biofamaceutica
Analytical method validation/verification Firm has submitted analytical method
of product validation study reports for drug substance as
well as drug product.
Manufacturer of API M/s Hebei Shengxue Dacheng Pharmaceutical Co Ltd. No. 50
Shengxue Road Launcheng District Shijiazhuang, Hebei Province,
China
Description of Pack
Clear glass vial
Real Time: 0, 1, 3, 6 (Months)
Batch No. CLI-001 CLI-002 CLI-003
Batch Size 46,511 vials 46,511 vials 31,000 vials
No. of Batches 03
DATA
firm (if any) data.
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate (No. HE20190058)
API manufacturer issued by concerned issued by China Food and Drug
regulatory authority of country of origin. Administration valid upto 14-08-2024 is
submitted
Colistimethate sodium. The invoice is
attested by AD (I&E) DRAP Lahore dated
19-11-2018 for batch # HN180401

5. Compliance Record of HPLC software Not available
testing
accelerated)
Evaluation by PEC:
• The applied product to be manufactured by M/s English Pharmaceuticals have already

been approved by Registration Board in its 296th meeting based on the data of same
batches of drug product as submitted in the instant case. The details of the already
Applicant firm M/s Macter International Limited. F-216, SITE, Karachi.

Manufacturer firm M/s English Pharmaceutical Industries Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road, Lahore.
Brand Name COLMIT 1MIU Injection
Batch No. of drug product CLI-001, CLI-002, CLI001*
Case No. 2553
meeting
* Batch number CLI-001 was a typo mistake in 296th meeting, actually this batch number was
CLI-003
Decision: Approved.
197. Name, address of Applicant / M/s Gray’s Pharmaceuticals Plot No. 2,

Marketing Authorization Holder Street # N-3, National Industrial Zone
Rawat Islamabad.
Name, address of Manufacturing site. M/s Bio-Next Pharmaceuticals Plot No. 50,
St No. S-10, RCCI Industrial Estate Rawat
Islamabad.
☐ Importer
giver)
Contract manufacturing agreement dated 12-
12-2020 is submitted
GMP status of the firm Firm has been granted new DML by way of
formulation dated 06-11-2019.

Evidence of approval of manufacturing Firm has submitted copy of Section approval
facility letter dated 06-11-2019 specifying Dry Vial
Injection section (Carbapenem).
☐ Export sale
The proposed proprietary name / brand GRAYNEM 500 mg Injection IV
name
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……..500mg
(Blended with sodium carbonate)
Pharmaceutical form of applied drug Glass vial filled with almost white powder
along with 10ml ampoule of WFI further
packed in unit carton.
Pharmacotherapeutic Group of (API) Carbapenem
specifications
authorities
For generic drugs (me-too status) Meronem Injection by ICI Pakistan Ltd.
Name and address of API manufacturer. Shenzhen Haibin Pharmaceutical Co., Ltd.
No. 2003, Shenyan Road, Yantian District,
Shenzhen City, Guangdong Province, P.R
China
product.

product against the comparator i.e. Meronem
500mg injection of Pfizer Limited.
of product analytical method for the drug substance and
drug product.
Manufacturer of API Shenzhen Haibin Pharmaceutical Co., Ltd. No. 2003, Shenyan
Road, Yantian District, Shenzhen City, Guangdong Province, P.R
China.
API Lot No. 8MT2103173
Batch No. 21E001 21E002 21E005
No. of Batches 03
DATA

1. Reference of previous approval of No Product Specific Inspection has been
applications with stability study data of the conducted since it is a new license.
firm (if any)
API manufacturer issued by concerned (No. GD20190927) issued by China Food and
regulatory authority of country of origin. Drug Administration dated 04-01-2019. The
approval from DRAP (in case of import). invoice cleared dated 22-04-2021 specifying
import of 160Kg meropenem. The invoice is
signed by AD (I&E) DRAP.
21CFR & audit trail reports on product product testing of HPLC.
testing
Evaluation by PEC:
Firm has initially submitted stability study data of three trial batches manufactured using drug
substance manufactured by M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial
Area Bhiwadi – District Alwar Rajasthan India. Later the firm submitted 6 months stability study
data of three commercial batches along with complete module 2 and module 3.
• Firm has not submitted fee for change of drug substance manufacturer and of change of
stability study batches.
• The specifications of the firm are not as per USP since it does not contain test for sodium
contents. Firm has not performed the test for sodium content at batch release or even
during the stability studies.
Decision: Approved.
• The Board further decided that the registration letter will be after submission of
revised drug product specification as per USP including test for sodium content
along with submission of applicable fee that is Rs. 7,500/- for revision of
• Board Authorized its Chairman for issuance of registration letter upon capacity
assessment of manufacturing and testing facility M/s Bio-Next Pharmaceuticals,
Rawat.
198. Name, address of Applicant / M/s Gray’s Pharmaceuticals Plot No. 2,
Marketing Authorization Holder Street # N-3, National Industrial Zone
Rawat Islamabad.
Islamabad.
☐ Importer
giver)

☐ Export sale
The proposed proprietary name / brand GRAYNEM 1g Injection IV
name
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……..1g
specifications
authorities
China
product.

1g injection of Pfizer Limited.
drug product.
China.
Batch No. 21E008 21E009 21E010

No. of Batches 03
DATA
firm (if any)
testing
Evaluation by PEC:
Decision: Approved.
Rawat.
199. Name, address of Applicant / M/s Islam Pharmaceuticals, 7-km Pasrur

Marketing Authorization Holder Road Sialkot.
Islamabad.

☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand MAXLAM 500 mg Injection IV
name
specifications
authorities
China

product.
500mg injection of Pfizer Limited.
drug product.
China.

Batch No. 21E001 21E002 21E005
No. of Batches 03
DATA
firm (if any)
testing
Evaluation by PEC:
Decision: Approved.
Rawat.
200. Name, address of Applicant / M/s Islam Pharmaceuticals, 7-km Pasrur
Marketing Authorization Holder Road Sialkot.

Islamabad.
☐ Importer
giver)
☐ Export sale
The proposed proprietary name / brand MAXLAM 1g Injection IV
name
specifications
authorities
China

product.
1g injection of Pfizer Limited.
drug product.
China.

Batch No. 21E008 21E009 21E010
No. of Batches 03
DATA
firm (if any)
testing
Evaluation by PEC:
Decision: Approved.

Rawat.
201. Name, address of Applicant / M/s Reliance Pharma. Plot No 8, Street

Marketing Authorization Holder No. S-8, Industrial Estate, Rawat,
Islamabad
Road Islamabad.
☐ Importer
giver)
GMP status of the firm Global pharmaceuticals: Firm has
submitted copy of GMP certificate dated 04-
01-2022 issued on the basis of inspection
dated 03-01-2022.
No 000417 of M/s Global Pharmaceuticals
Islamabad dated 18-12-2017 specifying
reallocation of dry powder injection
(carbapenem) section is place of withdrawn
Biotech section (BSF)
☐ Export sale
Details of fee submitted PKR 50,000/-: 27-04-2021 +
PKR 25,000/-: 28-06-2021
The proposed proprietary name / brand RELEM 500mg Injection
name
glass vials with sea green color flip off seal
along with 10ml WFI ampoule.
specifications

authorities
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

product against Merrem 500mg Injection
manufactured by Boehringer Ingelheim.
India.
API Lot No. S1/BMPM/0990917
S1/BMPM/1031017
Description of Pack
Glass vial
Batch No. 17L078 17L079 17M319
No. of Batches 03
DATA
1. Reference of previous approval of The firm has referred to previous inspection
applications with stability study data of the of stability data of the same dosage form on
firm (if any) the basis of which Registration Board in 289th
meeting decided to approve registration of
Promig Plus 500mg/20mg Tablet and Promig
Plus 375mg/20mg Tablet.
• The HPLC software is 21 CFR compliant.
• The firm has provided data loggers with
stability chambers.
API manufacturer issued by concerned (No. 12/80-2Drug1-2019/3739 issued by
regulatory authority of country of origin. Food and Drugs Administration Haryana
dated 21-05-2019. The certificate is valid till
2 years from the date of issue.
import of 20Kg (4x5Kg) Meropenem for
injection for Batch No. S1/BMPM/0990917.
The commercial invoice is attested by AD
(I&E) DRAP field office.

testing
Evaluation by PEC:
Firm was informed that
Registration Board in its 316th meeting considered the case of meroepem injection manufactured
by Global Pharmaceuticals, Islamabad wherein the Board decided as under:
Registration Board considered the case and noted the fact that the firm has not complied the
decision of 313th meeting, wherein Board “advised the manufacturer to perform product
development studies keeping in view the innovator product and product testing and stability
studies by complying USP monograph and
submit data upon completion of 6 months stability studies”, rather firm has submitted stability
data of batches manufactured prior to the decision of 313th meeting. Hence Board decided to
defer the application for submission of product development & stability studies in compliance
with the Innovator product literature and USP monograph. Board also directed the firm to
submit relevant sections of Form 5F against the new product development & stability studies
data along with submission of full fee of Rs. 75,000/-

Now the firm has submitted following data of three newly manufactured batches. Firm has also
changed the source of drug substance to CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co.
Ltd. No. 88, Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei
Province PR. China. Firm has not submitted any fee for change of source as well as
submission of stability study data of new batches.
Firm has also submitted following documents along with stability study data:
1. Specifications and analytical procedure of drug substance
2. Verification studies of the analytical procedure of drug substance
3. Specifications and analytical procedure of drug product
4. Verification studies of the analytical procedure of drug product
5. Pharmaceutical equivalence studies against Merrem 500mg Injection of Astra Zaneca
5. Process validation report of three commercial batches
6. CoA of working standard
7. Executed BMR of three batches
The details of the newly submitted data is as under:
Manufacturer of API M/s CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd. No.
88, Yangzi Road, Shijiazhuang Economic and Technological
Development Zone, Hebei Province PR. China.
API Lot No. 682107003

Description of Pack
Glass vial
Batch No. 22A169 22A363 22A364
No. of Batches 03
DATA
stability chambers.
API manufacturer issued by concerned (No. HE20180065) issued by China Food and
regulatory authority of country of origin. Drugs Administration dated 17-08-2018. The
import of 200Kg Meropenem for Batch No.
682107002 and 682107003. The commercial
invoice is attested by AD (I&E) DRAP field
office.
testing
Evaluation by PEC:
• Firm has changed the source of drug substance to CSPC Zhongnuo Pharmaceutical
(Shijiazhuang) Co. Ltd. No. 88, Yangzi Road, Shijiazhuang Economic and Technological

Development Zone, Hebei Province PR. China. Firm has not submitted any fee for
change of source as well as submission of stability study data of new batches.
Decision: Approved.
submission of applicable fee that is 75,000/- for change of source as well as
submission of stability study data of new batches as per notification No.F.7-11/2012-
assessment of manufacturing and testing facility of M/s Global Pharmaceuticals
(Pvt) Ltd. Plot No. 204-205, Industrial Triangle Kahuta Road Islamabad.
202. Name, address of Applicant / M/s Reliance Pharma. Plot No 8, Street
Marketing Authorization Holder No. S-8, Industrial Estate, Rawat,
Islamabad
Road Islamabad.
☐ Importer
giver)
dated 03-01-2022.
☐ Export sale
PKR 50,000/-: 28-06-2021
The proposed proprietary name / brand RELEM 1g Injection
name
meropenem……1g

glass vials with brown color flip off seal
specifications
authorities
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

India.
API Lot No. S1/MPM/01860817
Description of Pack
Glass vial
Batch No. 17K282 17K283 17K238
No. of Batches 03
DATA
stability chambers.

injection for Batch No. S1/MPM/01860817.
testing
Evaluation by PEC:
Firm was informed that
Registration Board in its 316th meeting considered the case of meroepem injection manufactured
by Global Pharmaceuticals, Islamabad wherein the Board decided as under:
Registration Board considered the case and noted the fact that the firm has not complied the
decision of 313th meeting, wherein Board “advised the manufacturer to perform product
development studies keeping in view the innovator product and product testing and stability
studies by complying USP monograph and
submit data upon completion of 6 months stability studies”, rather firm has submitted stability
data of batches manufactured prior to the decision of 313th meeting. Hence Board decided to
defer the application for submission of product development & stability studies in compliance
with the Innovator product literature and USP monograph. Board also directed the firm to
submit relevant sections of Form 5F against the new product development & stability studies
data along with submission of full fee of Rs. 75,000/-

API Lot No. 682107003

Description of Pack
Glass vial
Batch No. 22A335 21M270 21M271
No. of Batches 03
DATA
stability chambers.
office.
testing
Evaluation by PEC:

Decision: Approved.
203. Name, address of Applicant / M/s Carer Pharmaceuticals Industries,
Marketing Authorization Holder Plot No. 27, Main Road, Rawat Industrial
Estate Rawat Islamabad.
Road Islamabad.
☐ Importer
giver)
dated 03-01-2022.
☐ Export sale
The proposed proprietary name / brand CERONUM 500mg Injection
name
specifications

authorities
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

India.
S1/BMPM/1031017
Description of Pack
Glass vial
Batch No. 17L078 17L079 17M319
No. of Batches 03
DATA
stability chambers.

testing
Evaluation by PEC:
The firm was communicated the following decision of 312th meeting of Registration Board.
The product development and stability study data of the contract manufacturer was considered
by Registration Board in its 312nd meeting and observed that the contract manufacturer has not
performed complete product development studies, the specifications adopted by the
manufacturer throughout stability studies were not according to USP and that the stability batches
have also expired. Accordingly, the Board deferred for following submissions:
• Drug substance specifications and analytical procedures used for routine testing of the
Drug substance by both Drug Product manufacturer.
• Scientific justification for using flow rate of 1.0ml/min for assay testing of your
commercial batches since USP recommends flow rate to be 1.5ml/min,
• Scientific justification for having the method of sample solution preparation for the
commercial batches which is entirely different from that specified in USP monograph.
• Scientific justification for having analytical method of drug product without specifying
that “sample should be hold for 1-2 hours at 25± 1°C before testing” which is
recommended in USP monograph.
• Scientific justification for releasing the commercial batch of drug product and during
its stability studies even after having the value of tailing factor above 1.5, since USP
monograph specifies tailing factor NMT 1.5 in the system suitability requirements.
• Scientific justification for using different HPLC equipment and software for the
standard solution and the sample solution analysis.
• Scientific justification for HPLC testing of your commercial batches using UV detector
at 220nm while the USP recommends that testing be performed at 300nm.
• Scientific justification for using reference / working standard having a potency of
73.91% for the analysis of commercial batches.
• Scientific justification for having a master formulation containing 707mg of
meropenem trihydrate blended with sodium carbonate which is equivalent to 500mg
meropenem.
• Provision of details including batch number, expiry date and name of manufacturer of
the innovator product along with pharmaceutical equivalence was performed.
• Scientific justification why complete tests as mentioned in USP monograph were not
performed in pharmaceutical equivalence studies.
• Scientific justification for not performing compatibility studies of the drug product with
the recommended diluent.
• Scientific justification for not performing the test of sodium content and loss on drying
for the analysis of commercial batches of the drug product.

• Scientific justification for using an entirely different formula for calculation of assay
results of commercial batches from that specified in USP monograph.
• Scientific justification for not performing test of content of sodium, completeness and
clarity of solution, loss on drying and sterility test during the stability studies of the
product.
• Scientific justification for the results of assay test of meropenem for the batch No.
17L078 which show upward trend (i.e. increase in assay values with time) throughout
the stability studies (both accelerated and real time) keeping in view the fact that the
testing method was not exactly as per USP monograph, the reference standard
meropenem (trihydrate) for injection was used instead of meropenem (base), the
contents of sodium, as well as sodium carbonate was not determined at any time point
during stability studies and loss on drying is also not performed during the stability
studies.
• Scientific justification how three batches have been manufactured using 5Kg containers
while each batch required 5.4Kg drug substance.
• Evidence of purchase of atomic absorption spectrophotometer including commercial
invoice and Installation Qualification (IQ) and Operational Qualification (OQ) of
atomic absorption.
• Submission of fee for pre-registration changes in the drug product specifications.
Keeping in view the above, the Board decided that the submitted stability study data is not
acceptable and directed the manufacturer to either perform complete product development and
stability studies or submit the aforementioned data as per USP specifications and submit data
accordingly.

API Lot No. 682107003
Description of Pack
Glass vial

Batch No. 22A169 22A363 22A364
No. of Batches 03
DATA
stability chambers.
office.
testing
Evaluation by PEC:
Decision: Approved.

204. Name, address of Applicant / M/s Nagarsons Pharmaceuticals.

Marketing Authorization Holder Plot No. 34, St. No. NS-2, National
Industrial Zone, Rawat, Islamabad.
Road Islamabad.
☐ Importer
giver)
dated 03-01-2022.
☐ Export sale
The proposed proprietary name / brand MERONAG 500mg Injection
name
specifications

authorities
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

India.
S1/BMPM/1031017
Description of Pack
Glass vial
Batch No. 17L078 17L079 17M319
No. of Batches 03
DATA
stability chambers.

testing
Evaluation by PEC:
meropenem.

product.
studies.
atomic absorption.
accordingly.

API Lot No. 682107003
Description of Pack
Glass vial

Batch No. 22A169 22A363 22A364
No. of Batches 03
DATA
stability chambers.
office.
testing
Evaluation by PEC:
Decision: Approved.

205. Name, address of Applicant / M/s Nagarsons Pharmaceuticals.
Marketing Authorization Holder Plot No. 34, St. No. NS-2, National
Industrial Zone, Rawat, Islamabad.
Road Islamabad.
☐ Importer
giver)
dated 03-01-2022.
☐ Export sale
The proposed proprietary name / brand MERONAG 1g Injection
name
meropenem……1g
glass vials with brown color flip off seal
specifications

authorities
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

India.
Description of Pack
Glass vial
Batch No. 17K282 17K283 17K238
No. of Batches 03
DATA
stability chambers.
injection for Batch No. S1/MPM/01860817.

testing
Evaluation by PEC:
meropenem.
product.

studies.
atomic absorption.
accordingly.

API Lot No. 682107003
Description of Pack
Glass vial
Batch No. 22A335 21M270 21M271

No. of Batches 03
DATA
stability chambers.
office.
testing
Evaluation by PEC:
Decision: Approved.

206. Name, address of Applicant / M/s Leama Chemi Pharma Pvt Ltd. 37-
Marketing Authorization Holder A, Hayatabad Industrial Estate,
Peshawar
Name, address of Manufacturing site. M/s Gray’s Pharmaceutical Plot # 2, Street
# N-3, National Industrial Zone, Rawat
Islamabad
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 26126: dated 21-9-2021
LIMAXONE 250mg IM Injection
name
Active Pharmaceutical ingredient (API) Ceftriaxone sodium eq. to Ceftriaxone
per unit 250mg
Pharmaceutical form of applied drug Almost white to off white colored powder
filled in glass vial.
USP
specifications
MHRA approved
authorities
For generic drugs (me-too status) Topcef Injection of Ceftriaxone Sodium by
Pride Pharmaceuticals 025876
GMP status of the Finished product GMP certificate issued based upon
manufacturer inspection conduct 5-5-17, valid upto 4-5-
18.
Name and address of API manufacturer. M/s. Qilu Antibiotics Pharmaceutical CO.
Ltd. No. 849 Dongjia Town Licheng
District Jinan City China.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO
QOS-PD template.
Firm has summarized information related
to nomenclature, structure, general
manufacturers,

procedures and its validation, batch
reference standard, container closure
system and stability studies of drug
substance. The firm has summarized
process and process control, process
validation protocols, control of excipients,
control of drug product, specifications,
analytical procedures,
validation/verification of analytical
specifications, reference standard or
materials, container closure system and
stability.
Module III (Drug Substance) Firm has submitted detailed data for both
drug substance data related to
description of
impurities,
validation, batch analysis and justification
container closure system and stability
batches of drug substance at both
accelerated as well as real time conditions.
The accelerated stability data is conducted at
40 O ± 2 O C /75% ± 5% RH for 6 months.
30OC ± 2 O C / 65% ± 5% RH for 36 months.
(Batch No. 60155GJ81H-C, 60156GJ81H-
C, 6015GJ81H-C)
acidic and buffer medium) and its
Pharmaceutical equivalence and Firm has performed pharmaceutical
comparative dissolution profile equivalence against the product Oxidil
250mg Injection IM.

Analytical method Method verification studies have submitted
Manufacturer of API M/s. Qilu Antibiotics Pharmaceutical CO. Ltd. No. 849
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 124 125 126
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate GMP certificate of M/s. Qilu Antibiotics
of API manufacturer issued by concerned Pharmaceutical CO. Ltd. No. 849 Dongjia
regulatory authority of country of origin. Town Licheng District Jinan City China.
issued by State food and drug
administration china, valid Up to 5-6-2023.
import).

etc.
testing
6. Record of Digital data logger for Firm has submitted record of data logger
temperature and humidity monitoring of for temperature and humidity monitoring of
stability chambers (real time and real time and accelerated stability
accelerated) chambers.
Evaluation by PEC:
• The applied formulation to be manufactured by M/s Gray’s Pharmaceuticals, Rawat have
already been granted approval vide letter No.F.316-RB/2022 (PR-II) dated 26th May

2022. The case of the applied formulation of M/s Gray’s Pharmaceuticals, Rawat was
considered by Registration Board in its 316th meeting based on the data of same batches
of drug product as submitted in the instant case. The details of the already considered
product in 316th meeting are as follows:

Kashmir
Manufacturer firm M/s Gray’s Pharmaceuticals, Plot #2, Street # N-3,
National Industrial Zone, Rawat-Pakistan
Brand Name Trophin injection 250mg IM
Case No. 6
meeting
• The case was discussed in 316th meeting wherein Registration Board deliberated that as
case pertains to contract manufacturing of already registered drug products thus
authorized its Chairman for approval of contract manufacturing permission after
rectification of identified shortcomings and product specific inspection.
• After 316th meeting of Registration Board the case was considered in light of
rectifications of identified shortcomings (as identified in minutes of 316th meeting) and
product inspection report, and accordingly after approval by Chairman Registration
Board, letter for approval for the grant of contract manufacturing permission vide letter
No.F.316-RB/2022 (PR-II) dated 26th May 2022 was issued to M/s Akson
Pharmaceuticals was issued wherein the contract manufacturer was M/s Gray’s
Pharmaceuticals, Rawat.
Decision: Approved.
capacity assessment of manufacturing and testing facility of M/s Gray’s
Pharmaceutical Plot # 2, Street # N-3, National Industrial Zone, Rawat Islamabad.
207. Name, address of Applicant / M/s Alliance Pharmaceutical Pvt Ltd.
Marketing Authorization Holder 112 A, Hayatabad Industrial Estate,
Peshawar
Islamabad
☐ Importer
giver)
☐ Export sale

ROCEXON 250mg IM Injection
name
per unit 250mg
USP
specifications
MHRA approved
authorities
18.
QOS-PD template.
manufacturers,
stability.
description of

impurities,
40 O ± 2 O C /75% ± 5% RH for 6 months.
(Batch No. 60155GJ81H-C, 60156GJ81H-
C, 6015GJ81H-C)
250mg Injection IM.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 124 125 126
No. of Batches 03

the firm (if any)
import).

etc.
testing
Evaluation by PEC:

Kashmir
Brand Name Trophin injection 250mg IM
Case No. 6
meeting

Decision: Approved.
208. Name, address of Applicant / Marketing M/s Alliance Pharmaceutical Pvt Ltd.
Authorization Holder 112 A, Hayatabad Industrial Estate,
Peshawar
Islamabad
☐ Importer
giver)
☐ Export sale
ROCEXON 250mg IV Injection
name
per unit 250mg
USP
specifications
MHRA approved
authorities
18.

PD template.
stability studies of drug substance. The firm
has summarized
stability.
impurities,
40 O ± 2 O C /75% ± 5% RH for 6 months.
(Batch No. 60155GJ81H-C, 60156GJ81H-
C, 6015GJ81H-C)

250mg Injection IV.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 103 115 120
Batch Size 5,000 packs 5,000 packs 5,000 packs
No. of Batches 03
the firm (if any)
import).
etc.
testing
Evaluation by PEC:


Kashmir
Brand Name Trophin injection 250mg IV
Case No. 7
meeting
Decision: Approved.
Peshawar
Name, address of Manufacturing site. M/s Gray’s Pharmaceutical Plot # 2,
Street # N-3, National Industrial Zone,
Rawat Islamabad
☐ Importer
☒ Is involved in none of the above
(contract giver)
☐ Export sale

LIMAXONE 500mg IM Injection
name
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium eq. to Ceftriaxone
500mg
USP
specifications
MHRA approved
authorities
For generic drugs (me-too status) Topcef 500mg Injection of M/s. Pride
18.
QOS-PD template.
manufacturers,
stability.
nomenclature, structure, general

impurities,
specifications, analytical procedures and
its validation, batch analysis and
Stability studies Firm has submitted stability study data of
3 batches of drug substance at both
The accelerated stability data is conducted
at 40 O ± 2 O C /75% ± 5% RH for 6
months. The real time stability data is
conducted at 30OC ± 2 O C / 65% ± 5%
RH for 36 months (Batch No.
60155GJ81H-C, 60156GJ81H-C,
6015GJ81H-C))
comparative dissolution profile equivalence against the product Rocephin
Pharmaceuticals 500mg IM.
Analytical method validation/verification Method verification studies have
of product submitted including linearity, range,
accuracy, precision, specificity.
API Lot No. 0151NJ81HE (RM 4987)
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 109 114 119
Batch Size 6,000 packs 14000 packs 15000 packs

No. of Batches 03
firm (if any)
API manufacturer issued by concerned Pharmaceutical CO. Ltd. No. 849 Dongjia
administration china, valid Up to 5-6-
2023.
3. Documents for the procurement of API Firm has submitted attested copy of
with approval from DRAP (in case of invoice (invoice#JTRF210117-MQ)
import).

testing
temperature and humidity monitoring of for temperature and humidity monitoring
stability chambers (real time and of real time and accelerated stability
Evaluation by PEC:

Kashmir
Brand Name Trophin Injection 500mg IM
Case No. 4
meeting

Decision: Approved.
Peshawar
Rawat Islamabad
☐ Importer
(contract giver)
☐ Export sale
ROCEXON 500mg IM Injection
name
Pharmaceutical ingredient (API) per unit Ceftriaxone sodium eq. to Ceftriaxone
500mg
USP
specifications
MHRA approved
authorities
For generic drugs (me-too status) Topcef 500mg Injection of M/s. Pride

18.
QOS-PD template.
manufacturers,
stability.
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6
conducted at 30OC ± 2 O C / 65% ± 5%
RH for 36 months (Batch No.
60155GJ81H-C, 60156GJ81H-C,
6015GJ81H-C))

Pharmaceuticals 500mg IM.
API Lot No. 0151NJ81HE (RM 4987)
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 109 114 119
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Pharmaceutical CO. Ltd. No. 849 Dongjia
administration china, valid Up to 5-6-
2023.
import).

testing
Evaluation by PEC:

Kashmir
Brand Name Trophin Injection 500mg IM
Case No. 4
meeting
Decision: Approved.
Peshawar

Islamabad
☐ Importer
giver)
☐ Export sale
LIMAXONE 500mg IV Injection
name
per unit 500mg
USP
specifications
MHRA approved
authorities
18.
QOS-PD template.
manufacturers,

stability.
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6
conducted at 30OC ± 2 O C / 65% ± 5% RH
for 36 months. (Batch No. 60155GJ81H-
C, 60156GJ81H-C, 6015GJ81H-C))

500 mg IV.
Analytical method validation/verification Method verification studies have submitted
of product including linearity, range, accuracy,

Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 109 114 119
No. of Batches 03
the firm (if any)
import).

testing
Evaluation by PEC:

Kashmir
Brand Name Trophin Injection 500mg IV
Case No. 5
meeting
Decision: Approved.
Peshawar
Islamabad
☐ Importer
giver)
☐ Export sale
ROCEXON 500mg IV Injection
name
per unit 500mg

USP
specifications
MHRA approved
authorities
18.
QOS-PD template.
manufacturers,
stability.
impurities,

at 40 O ± 2 O C /75% ± 5% RH for 6
for 36 months. (Batch No. 60155GJ81H-
C, 60156GJ81H-C, 6015GJ81H-C))

500 mg IV.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 109 114 119
No. of Batches 03

the firm (if any)
Pharmaceutical CO. Ltd. No. 849 Dongjia
Town Licheng District Jinan City China.
import).

testing
Evaluation by PEC:

Kashmir
Brand Name Trophin Injection 500mg IV
Case No. 5
meeting

Decision: Approved.
Peshawar
# N-3,
☐ Importer
giver)
☐ Export sale
ROCEXON 1gm IV/IM Injection
name
Active Pharmaceutical ingredient (API) Ceftriaxone sodium eq. to Ceftriaxone 1gm
per unit
USP
specifications
MHRA approved
authorities
For generic drugs (me-too status) Topcef 1g Injection of M/s. Pride
18.
QOS-PD template.

manufacturers,
stability.
description of
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6
for 36 months. (Batch No. 60155GJ81H-C,
60156GJ81H-C, 6015GJ81H-C))

Injection 1g IM.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 124 125 126
No. of Batches 03
the firm (if any)
import).

etc.
testing

Evaluation by PEC:

Kashmir
Brand Name Trophin Injection 1 gm IV/IM later approved as Trophin
Injection 1 gm IV
Case No. 3
meeting
• Firm has applied for both IV/IM injection however the data of contract
manufacturer i.e. M/s Gray’s Pharmaceuticals already considered and approved in
316th meeting was for 1gm IV Injection.
Decision: Approved as IV Injection.
Registration Board Authorized its Chairman for issuance of registration letter upon
capacity assessment of manufacturing and testing facility of M/s Gray’s Pharmaceutical
Plot # 2, Street # N-3, National Industrial Zone, Rawat Islamabad.
214. Name, address of Applicant / M/s Iceberg Pharmaceuticals Pvt Ltd.
Marketing Authorization Holder Plot # 144, Nowshera Indsutrial Estate,
Risalpur
# N-3,
☐ Importer
giver)

☐ Export sale
CEFTIME 500mg IV/IM Injection
name
Active Pharmaceutical ingredient (API) Cefotaxime sodium eq. to Cefotaxime…
per unit 500mg
USP
specifications
USFDA approved
authorities
For generic drugs (me-too status) Cefotaxime 500mg Injection of M/s.
Friends Pharma
18.
QOS-PD template.
manufacturers,

stability.
description of
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6
for 36 months.
Batch numbers: (3079GL81F, 3078GL81F,
3080GL81F)
comparative dissolution profile equivalence against the product Claforan
Injection 500mg.
API Lot No. 0089L81F
Description of Pack
Glass vial

Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. TDI001 TDI002 TDI003
No. of Batches 03
the firm (if any)
of API manufacturer issued by Pharmaceutical CO. Ltd. No. 849 Dongjia
concerned regulatory authority of Town Licheng District Jinan City China.
country of origin. issued by State food and drug
import).
etc.
testing
Evaluation by PEC:

Kashmir
Brand Name Onexin Injection 500mg
Batch No. of drug product TDI001, TDI002, TDI003
Case No. 12

meeting
Decision: Approved.
Risalpur
# N-3,
☐ Importer
giver)
☐ Export sale
CEFTIME 1g IV/IM Injection
name
Active Pharmaceutical ingredient (API) Cefotaxime sodium eq. to Cefotaxime 1gm
per unit
USP
specifications

USFDA approved
authorities
For generic drugs (me-too status) Cefotaxime 1g Injection of M/s. Friends
Pharma
18.
QOS-PD template.
manufacturers,
stability.
description of
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6

for 36 months.
Batch numbers: (3079GL81F, 3078GL81F,
3080GL81F)
comparative dissolution profile equivalence against the product Claforan
Injection 1g.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
No. of Batches 03
the firm (if any)
of API manufacturer issued by Pharmaceutical CO. Ltd. No. 849 Dongjia
concerned regulatory authority of Town Licheng District Jinan City China.
country of origin. issued by State food and drug

import).
etc.
testing
Evaluation by PEC:

Kashmir
Brand Name Kerazon Plus Injection 1g
Case No. 12
meeting
Decision: Approved.

Peshawar
# N-3,
☐ Importer
giver)
☐ Export sale
CEPTAM 1g IV/IM Injection
name
Active Pharmaceutical ingredient (API) Cefoperazone (as
per unit sodium)……………..500mg
Sulbactam (as sodium)……………500mg
Innovator
specifications
The status in reference regulatory Firm has provided reference from EMA
authorities website where this combination is registered
as Sulperazone 1 & 2 gm Injection by Pfizer
in following countries:
• Poland
• Slovakia
• Lithuania
• Czech Republic
• Italy
• Bulgaria
For generic drugs (me-too status) Adzone 1g Injection of M/s. Farm Aid
group
18.

QOS-PD template.
manufacturers,
stability.
description of
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6
for 36 months
(Batches: 9001HK81NG; 9002HK81NG;
9003HK81NG)

comparative dissolution profile equivalence against the product Sulzone
Injection 1g.
validation/verification of product including linearity, range, accuracy &
recovery, method precision, specificity
bearing document number GP/QC-SAP-052
effective date 5-6-2018.
API Lot No. 101AJ81NE
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
No. of Batches 03
the firm (if any)
import).

etc.

testing
Evaluation by PEC:

Kashmir
Case No. 14
meeting
Decision: Approved with JP Specifications.
• Registration Board decided that registration letter will be issued after submission
of applicable fee for revision of specifications as per notification No.F.7-11/2012-

Risalpur
# N-3,

☐ Importer
giver)
☐ Export sale
ASOFEN 1gm IV/IM Injection
name
Active Pharmaceutical ingredient (API) Cefoperazone (as
per unit sodium)……………..500mg
Sulbactam (as sodium)……………500mg
Innovator
specifications
authorities website where this combination is registered
as Sulperazone 1 & 2 gm Injection by Pfizer
in following countries:
• Poland
• Slovakia
• Lithuania
• Czech Republic
• Italy
• Bulgaria
group
18.
QOS-PD template.

manufacturers,
stability.
description of
impurities,
at 40 O ± 2 O C /75% ± 5% RH for 6
for 36 months
(Batches: 9001HK81NG; 9002HK81NG;
9003HK81NG)

comparative dissolution profile equivalence against the product Sulzone
Injection 1g.
validation/verification of product including linearity, range, accuracy &
recovery, method precision, specificity
bearing document number GP/QC-SAP-052
effective date 5-6-2018.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
No. of Batches 03
the firm (if any)
import).

etc.
testing

Evaluation by PEC:

Kashmir
Case No. 14
meeting
218. Name, address of Applicant / Marketing M/s Alliance Pharmaceutical Pvt Ltd.
Authorization Holder 112 A, Hayatabad Industrial Estate,
Peshawar
Rawat Islamabad
☐ Importer
(contract giver)

☐ Export sale
CEPTAM 2g IV/IM Injection
name
Pharmaceutical ingredient (API) per unit Cefoperazone (as
Sodium)……………..1g
Sulbactam (as sodium)……………1g
Pharmaceutical form of applied drug Almost white to off white colored
powder filled in glass vial.
Innovator
specifications
authorities website where this combination is
registered as Sulperazone 1 & 2 gm
Injection by Pfizer in following
countries:
• Poland
• Slovakia
• Lithuania
• Czech Republic
• Italy
• Bulgaria
group
manufacturer inspection conduct 5-5-17, valid upto 4-
5-18.
Name and address of API manufacturer. M/s. Qilu Antibiotics Pharmaceutical
CO. Ltd. No. 849 Dongjia Town
QOS-PD template.
Firm has summarized information
related to nomenclature, structure,
form, manufacturers,
Characterization, specifications,
analytical procedures and its validation,
specification, reference standard,

studies of drug substance. The firm has
summarized
development, manufacture,
manufacturing process and process
control, process validation protocols,
control of excipients, control of drug
product, specifications, analytical
procedures, validation/verification of
analytical procedures, batch analysis,
standard or materials, container closure
Module III (Drug Substance) Firm has submitted detailed data for
both drug substance data related to
impurities,
Stability studies Firm has submitted stability study data
of 3 batches of drug substance at both
accelerated as well as real time
conditions. The accelerated stability data
is conducted at 40 O ± 2 O C /75% ± 5%
RH for 6 months. The real time stability
data is conducted at 30OC ± 2 O C / 65%
± 5% RH for 36 months (9001HK81NG;
9002HK81NG; 9003HK81NG)
procedure (including dissolution testing
at acidic and buffer medium) and its
comparative dissolution profile equivalence against the Firm has
performed pharmaceutical equivalence
against the product Sulzone Injection2 g.
Analytical method validation/verification of Method validation studies have
product submitted including linearity, range,
accuracy & recovery, method precision,

specificity bearing document number
GP/QC-SAP-052 effective date 5-6-
2018.
Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Pharmaceutical CO. Ltd. No. 849
regulatory authority of country of origin. Dongjia Town Licheng District Jinan
City China. issued by State food and
drug administration china, valid Up to 5-
6-2023.
3. Documents for the procurement of API with Firm has submitted attested copy of
approval from DRAP (in case of import). invoice (invoice#JTRF210117-MQ)

testing
Evaluation by PEC:


Kashmir
Case No. 15
meeting
219. Name, address of Applicant / Marketing M/s Iceberg Pharmaceuticals Pvt Ltd.
Authorization Holder Plot # 144, Nowshera Indsutrial
Estate, Risalpur
Rawat Islamabad
☐ Importer
(contract giver)
☐ Export sale

ASOFEN 2gm IV/IM Injection
name
Pharmaceutical ingredient (API) per unit Cefoperazone (as
Sodium)……………..1g
Sulbactam (as sodium)……………1g
Pharmaceutical form of applied drug Almost white to off white colored
powder filled in glass vial.
Innovator
specifications
authorities website where this combination is
registered as Sulperazone 1 & 2 gm
Injection by Pfizer in following
countries:
• Poland
• Slovakia
• Lithuania
• Czech Republic
• Italy
• Bulgaria
group
manufacturer inspection conduct 5-5-17, valid upto 4-
5-18.
Name and address of API manufacturer. M/s. Qilu Antibiotics Pharmaceutical
CO. Ltd. No. 849 Dongjia Town
QOS-PD template.
Firm has summarized information
related to nomenclature, structure,
form, manufacturers,
Characterization, specifications,
analytical procedures and its validation,
studies of drug substance. The firm has
summarized

standard or materials, container closure
Module III (Drug Substance) Firm has submitted detailed data for
both drug substance data related to
impurities,
Stability studies Firm has submitted stability study data
of 3 batches of drug substance at both
accelerated as well as real time
conditions. The accelerated stability data
is conducted at 40 O ± 2 O C /75% ± 5%
RH for 6 months. The real time stability
data is conducted at 30OC ± 2 O C / 65%
± 5% RH for 36 months (9001HK81NG;
9002HK81NG; 9003HK81NG)
comparative dissolution profile equivalence against the Firm has
performed pharmaceutical equivalence
against the product Sulzone Injection2 g.
Analytical method validation/verification of Method validation studies have
product submitted including linearity, range,
accuracy & recovery, method precision,
specificity bearing document number
GP/QC-SAP-052 effective date 5-6-
2018.

Description of Pack
Glass vial
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Pharmaceutical CO. Ltd. No. 849
regulatory authority of country of origin. Dongjia Town Licheng District Jinan
City China. issued by State food and
drug administration china, valid Up to 5-
6-2023.
3. Documents for the procurement of API with Firm has submitted attested copy of
approval from DRAP (in case of import). invoice (invoice#JTRF210117-MQ)

testing
Evaluation by PEC:

Kashmir
Case No. 15
meeting
Peshawar
Name, address of Manufacturing site. M/s Gray’s Pharmaceuticals, Plot #2,
Rawat-Pakistan
☐ Importer
giver)
☐ Export sale
LEXIME 100mg/5ml Suspension
name

Strength / concentration of drug of Each 5ml Dry Suspension contains:
Active Pharmaceutical ingredient (API) Cefixime as trihydrate……. 100mg
per unit
Pharmaceutical form of applied drug Dry Suspension
Pharmacotherapeutic Group of (API) Anti-Biotic (Cephalosporin)
USP
specifications
Proposed Pack size 1×30ml’s
The status in reference regulatory Suprex 100mg /5ml Dry Suspension by M/s
authorities Lupin Pharma, USFDA Approved.
For generic drugs (me-too status) Cefspan 100mg /5ml Dry Suspension by
M/s Barrett Hodgson, Reg. No. 010429
manufacturer (Cephalosporin Antibiotic) section
approved.
Name and address of API manufacturer. M/s CITI Pharmacueticals (PVT.) LTD.
588-Q, Johar Town,
Lahore – 53100, Pakistan
Module III (Drug Substance) Official monograph of Cefixime as
Trihydrate is present in USP. The firm as
submitted detail of nomenclature, structure,
manufacturing process and controls, tests
for impurity & related substances,
months
6 months
Batches: (CFM1602001,CFM1602002,
CFM1602003)

Pharmaceutical equivalence and Pharmaceutical Equivalence has been
comparative dissolution profile established against the brand leader that is
Cefspan 100mg /5ml Dry Suspension by
M/s Barrett Hodgson.
Manufacturer of API M/s CITI Pharmacueticals (PVT.) LTD. 588-Q, Johar Town,
API Lot No. CFM2101001
Description of Pack
PET Bottle packed in unit carton (1×30ml’s)
Date of Initiation 03.02.2021 03-02-2021 03.02.2021
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Submitted
3. Documents for the procurement of API N/A

import).

4. Data of stability batches will be supported
sheets etc.
testing
Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name AKSOXIME 100mg/5ml Dry Suspension
Batch No. of drug product T-007, T-008, T-009
Case No. 9
meeting
Decision: Approved.
Peshawar

Rawat-Pakistan
Status of the applicant ☐Manufacturer
☐ Importer
giver)
☐ Export sale
LEXIME 200mg/5ml Suspension
name
Strength / concentration of drug of Each 5ml Dry Suspension contains:
Active Pharmaceutical ingredient (API) Cefixime as trihydrate ……. 200mg
per unit
Pharmaceutical form of applied drug Dry Suspension
USP
specifications
Proposed Pack size 1×30ml’s
The status in reference regulatory Suprex 200mg /5ml Dry Suspension by M/s
authorities Lupin Pharma, USFDA Approved.
For generic drugs (me-too status) Cefspan 200mg /5ml Dry Suspension by
M/s Barrett Hodgson, Reg. No. 024634
manufacturer (Cephalosporin Antibiotic) section
approved.
Name and address of API manufacturer. M/s CITI Pharmacueticals (PVT.) LTD.
588-Q, Johar Town,

Module III (Drug Substance) Official monograph of Cefixime as
Trihydrate is present in USP. The firm as
months
6 months
Batches: (CFM1602001,CFM1602002,
CFM1602003)
Cefspan 200mg /5ml Dry Suspension by
M/s Barrett Hodgson, by performing quality
tests (Identification, Assay, and Uniformity
of dosage form).
Manufacturer of API M/s CITI Pharmacueticals (PVT.) LTD. 588-Q, Johar Town,
Description of Pack
PET Bottle packed in unit carton (1×30ml’s)

No. of Batches 03
the firm (if any)
import).
Submitted
testing
Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name AKSOXIME 200mg/5ml Dry Suspension
Case No. 10
meeting

Decision: Approved.
Peshawar
Rawat-Pakistan
☐ Importer
giver)
☐ Export sale
LEXIME 400mg Capsule
name
Strength / concentration of drug of Each capsule contains:
Active Pharmaceutical ingredient (API) Cefixime as trihydrate……. 400 mg
per unit
Pharmaceutical form of applied drug Hard Gelatin Capsule
JP
specifications
The status in reference regulatory Suprex 400mg Capsule by M/s Lupin
authorities Pharma, USFDA Approved.
For generic drugs (me-too status) Cefspan 400mg capsule by M/s Barrett
Hodgson, Reg. No. 013860
manufacturer

(Cephalosporin Antibiotic) section
approved.
Name and address of API manufacturer. M/s Citi Pharma (Pvt.) Ltd.
3 Kilometer, Head Balloki Road, Phool
Nagar, Kasur -55050
Punjab, Pakistan.
Tel: +92 49 4510192, 510189
Fax: +92 49 4510191
Website: www.citipharma.com
Email ID: info@citipharma.com
Module III (Drug Substance) Official monograph of Cefixime is present
in JP. The firm as submitted detail of
controls, tests for impurity & related
substances, specifications, analytical
months
6 months
Batches: (CFM1602001, CFM1602002,
CFM1602003)
Pharmaceutical equivalence and Pharmaceutical Equivalence have been

Cefspan 400mg capsule by M/s Barrett
Hodgson,
CDP has been performed against the same
brand that is Cefspan 400mg capsule by M/s
Barrett Hodgson, in A , Acetate Buffer (pH
4.5) , Phosphate Buffer (pH 6.8) & Kcl
Buffer (pH 1.2). The values for f1 and f2 are
in the acceptable range.
Manufacturer of API M/s Citi Pharma (Pvt.) Ltd.

3 Kilometer, Head Balloki Road, Phool Nagar, Kasur -55050
Punjab, Pakistan.
Tel: +92 49 4510192, 510189
Fax: +92 49 4510191
Website: www.citipharma.com
Email ID: info@citipharma.com
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
the firm (if any)

import).

by attested respective documents like Submitted
chromatograms,

sheets etc.

testing
Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name AKSOXIME 400mg capsule
Case No. 11
meeting
Decision: Approved with Manufacturer’s Specifications as approved by Registration
Board in its 313th meeting and notified vide letter No. F.14-I/2022-PEC dated 14th March
2022.

Risalpur
Rawat-Pakistan
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 26937 dated 29.09.2021
Details of fee submitted PKR 75000/-: dated 30.06.2021
CEF-ICE 500mg IV/IM Injection
name
Strength / concentration of drug of Each vial Contains:
Active Pharmaceutical ingredient (API) Cefepime (as hydrochloride)….……500mg
per unit (with L-arginine)
Pharmaceutical form of applied drug Powder For Solution For Injection Or
Infusion
USP
specifications
The status in reference regulatory Renapime 500mg Powder for solution for
authorities injection/infusion
Manufacturer: Renascience Pharma Ltd
(MHRA approved)
For generic drugs (me-too status) Maxipime 1g Injection by M/s Novartis
GMP status of the Finished product Tablet (General), Capsule (General), Dry
manufacturer Suspension (Ceph), Capsule (Ceph), Dry
powder injection (Ceph), cream & Ointment
and ampule section approved.
Name and address of API manufacturer. M/s Qilu Antibiotics Pharmaceutical Co.,
Ltd.
No.849 Dongjia Town, Licheng District,
Jinan, Shandong Province, China

Module III (Drug Substance) Official monograph of Cefepime HCl is
present in USP. The firm as submitted detail
of nomenclature, structure, general
months
6 months
Batches: (T-034, T-035, T-036)
Maxipime 1g Injection by M/s Novartis
Manufacturer of API M/s Qilu Antibiotics Pharmaceutical Co., Ltd.

No.849 Dongjia Town, Licheng District, Jinan, Shandong
Province, China
API Lot No. 0022CJ66DB
Description of Pack
USP type III glass vial. Packed in a unit carton with leaflet

Batch No. T-034 T-035 T-036
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. SD20160497
of API manufacturer issued by concerned issued by China food and Drug
regulatory authority of country of origin. administration valid till 25/08/2021.
3. Documents for the procurement of API • Commercial invoice and ADC

with approval from DRAP (in case of clearance of the same batch of API
import). as used in the stability studies.

sheets etc.
testing
Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name Endopime 500mg powder for solution for injection or
infusion

Case No. 8
meeting
Decision: Approved.
Peshawar.
Rawat-Pakistan
☐ Importer
giver)
☐ Export sale
EPIME 500mg IV/IM Injection
name
Active Pharmaceutical ingredient (API) Cefepime (as hydrochloride)….……500mg
per unit (with L-arginine)
Pharmaceutical form of applied drug Powder For Solution For Injection Or
Infusion
USP
specifications

The status in reference regulatory Renapime 500mg Powder for solution for
(MHRA approved)
Ltd.
No.849 Dongjia Town, Licheng District,
Module III (Drug Substance) Official monograph of Cefepime HCl is
present in USP. The firm as submitted detail
months
6 months
Batches: (T-034, T-035, T-036)


Province, China
Description of Pack
Batch No. T-034 T-035 T-036
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. SD20160497
of API manufacturer issued by concerned issued by China food and Drug
regulatory authority of country of origin. administration valid till 25/08/2021.
3. Documents for the procurement of API • Commercial invoice and ADC

with approval from DRAP (in case of clearance of the same batch of API
import). as used in the stability studies.

sheets etc.
testing

Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name Endopime 500mg powder for solution for injection or
infusion
Case No. 8
meeting
Decision: Approved.
225. Name, address of Applicant / M/s Iceberg Pharmaceuticals Pvt Ltd. Plot #
Marketing Authorization Holder 144, Nowshera Indsutrial Estate, Risalpur
Name, address of Manufacturing M/s Gray’s Pharmaceuticals, Plot #2, Street #
site. N-3, National Industrial Zone, Rawat-Pakistan
☐ Importer
giver)

CEF-ICE 1gm IV/IM Injection
brand name
Active Pharmaceutical ingredient Cefepime (as hydrochloride)….……1g
(API) per unit (with L-arginine)
Pharmaceutical form of applied drug Powder For Solution For Injection Or Infusion
USP
specifications
The status in reference regulatory Renapime 1g Powder for solution for
(MHRA approved)
Name and address of API M/s Qilu Antibiotics Pharmaceutical Co., Ltd.
manufacturer. No.849 Dongjia Town, Licheng District,
submitted.
Module III (Drug Substance) Official monograph of Cefepime HCl is present
in USP. The firm has submitted detail of

months
months
Batches: (T-037, T-038, T-039)
product.
specificity.

Province, China
Description of Pack
Batch No. T-037 T-038 T-039
No. of Batches 03

2. Approval of API/ DML/GMP Copy of GMP certificate No. SD20160497
certificate of API manufacturer issued issued by China Food and Drug Administration
by concerned regulatory authority of valid till 25/08/2021.
country of origin.
3. Documents for the procurement of • Commercial invoice and ADC
API with approval from DRAP (in clearance of the same batch of API as
case of import). used in the stability studies.

documents like chromatograms, Submitted
sheets etc.
software 21CFR & audit trail reports Submitted
on product testing
Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name Endopime 1g powder for solution for injection or infusion
Case No. 2
meeting

Decision: Approved.
226. Name, address of Applicant / Alliance Pharmaceutical Pvt Ltd. 112 A,
Marketing Authorization Holder Hayatabad Industrial Estate, Peshawar
Name, address of Manufacturing M/s Gray’s Pharmaceuticals, Plot #2, Street #
site. N-3, National Industrial Zone, Rawat-Pakistan
☐ Importer
giver)
EPIME 1gm IV/IM Injection
brand name
Active Pharmaceutical ingredient Cefepime (as hydrochloride)….……1g
(API) per unit (with L-arginine)
Pharmaceutical form of applied drug Powder For Solution For Injection Or Infusion
USP
specifications
The status in reference regulatory Renapime 1g Powder for solution for
(MHRA approved)
Name and address of API M/s Qilu Antibiotics Pharmaceutical Co., Ltd.
manufacturer. No.849 Dongjia Town, Licheng District,

submitted.
Module III (Drug Substance) Official monograph of Cefepime HCl is present
months
months
Batches: (T-037, T-038, T-039)
product.
specificity.

Province, China
Description of Pack

Batch No. T-037 T-038 T-039
No. of Batches 03
certificate of API manufacturer issued issued by China Food and Drug Administration
country of origin.
3. Documents for the procurement of • Commercial invoice and ADC
API with approval from DRAP (in clearance of the same batch of API as
case of import). used in the stability studies.

sheets etc.
software 21CFR & audit trail reports Submitted
on product testing
Submitted
accelerated)
Evaluation by PEC:

Kashmir
Brand Name Endopime 1g powder for solution for injection or infusion
Case No. 2
meeting

Decision: Approved.
227. Name, address of Applicant / M/s Alliance Pharmaceutical Pvt Ltd. 112 A,
Marketing Authorization Holder Hayatabad Industrial Estate, Peshawar
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No. 145,
☐ Importer
giver)
GMP status of the firm Firm has submitted copy of GMP certificate of
M/s Bio-Labs dated 21-05-2019 based on the
inspection dated 23-04-2019. The certificate is
The GMP certificate specifies Lyophilized vial
(General) section.
Evidence of approval of manufacturing Firm has submitted copy of GMP certificate of
facility M/s Bio-Labs dated 21-05-2019 based on the
The GMP certificate specifies Lyophilized vial
(General) section.
Firm has also submitted copy of letter for grant
of additional section dated 23-07-2012
specifying Lyophilized vial (General) section.
☐ Export sale
The proposed proprietary name / brand ALLOZOLE Injection 40mg
name

Active Pharmaceutical ingredient (API) Esomeprazole (as sodium)……40mg
per unit
Pharmaceutical form of applied drug Almost white coloured lyophilized
hygroscopic powder contained in glass vial
Pharmacotherapeutic Group of (API) PPI
specifications
The status in reference regulatory Nexium IV Injection (USFDA Approved)
authorities
For generic drugs (me-too status) Nexum injection by Getz Pharma
Name and address of API manufacturer. Sterile India Pvt Ltd. Plot No. 100, Sec-56
Phase-4, Kundli Sonipat (Haryana) India.
product.
Module-III Drug Substance: Firm has submitted detailed data for both drug
stability data is conducted at 40oC ± 2oC / 75%
data is conducted at 30oC ± 2oC / 65% ± 5% RH
for 36 months.

product against the comparator i.e. Nexum
40mg Injection.
Analytical method Firm has submitted report of verification of
validation/verification of product analytical method for the drug substance.
Manufacturer of API Sterile India Pvt Ltd. Plot No. 100, Sec-56 Phase-4, Kundli Sonipat
(Haryana) India.
API Lot No. SI/BEPZ/00061019
Description of Pack
(Container closure Glass vials
system)
Batch No. L-315 L-287 L-283
No. of Batches 03
DATA
1. Reference of previous approval of Firm has refered to their previous inspection
applications with stability study data of conducted for Empaglif 10mg Tablet
the firm (if any) (Empagliflozin) & Empaglif 25mg Tablet
which was considered by the Board in its 296th
meeting and the product was approved based on
the inspection report. Following points were
noted during the inspection:
• All the stability study of EMPAGLIF (10mg &
25mg) Tablets has been conduct on Shimadzu
HPLC (Model SPD-20) operated via
LABSOLUTION software version 6.5
(complying FDA 21 CFR part 11)
• Audit trail reports for Testing of Empaglif
10mg & 25mg Tablets are available.
• Proper and continuous monitoring record for
stability chamber is available, along with 5KV
backup generator with ATS.

of API manufacturer issued by concerned (No. 12/80-2Drug1-2019/3739 issued by Food
regulatory authority of country of origin. and Drugs Administration Haryana dated 21-
05-2019. The certificate is valid till 2 years from
the date of issue.
3. Documents for the procurement of API Firm has submitted copy of commercial invoice
with approval from DRAP (in case of specifying import of 5Kg Esomeprazole sodium
import). sterile powder dated 02-12-2019. The invoice is
cleared by AD (I&E) DRAP.
4. Data of stability batches will be supported Firm has submitted complete record of testing
by attested respective documents like of all batches along with chromatograms, raw
chromatograms, Raw data sheets, COA, data sheets, COA and summary data sheets.
5. Compliance Record of HPLC software Firm has not submitted audit trail reports for the
21CFR & audit trail reports on product product testing
testing
accelerated)
Evaluation by PEC:
• Submit differential fee for the registration of applied product, since the notification for
revision of fee vide SRO No. F.7-11/2012-B&A/DRA was published on 7th May 2021
while this application was received in R&I section of DRAP after 7th May 2021.
• Manufacturer has changed specifications of the drug product without submission of fee.
• The applied product to be manufactured by M/s Bio-Labs (Pvt) Ltd. Plot No. 145,
Industrial Triangle Kahuta Road Islamabadhave already been approved by Registration
Board in its 316th meeting based on the data of same batches of drug product as submitted
in the instant case. The details of the already approved product in 316th meeting are as
follows:
Applicant firm M/s Gray’s Pharmaceuticals. Plot No. 2, Street No. N-3,
RCCI Rawat Rawalpindi.
Manufacturer firm M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial Triangle
Kahuta Road Islamabad
Brand Name ESOMEP Injection 40mg
Batch No. of drug product L-315, L-287, L-283
Case No. 787
meeting
Decision: Approved.
• Firm shall submit differential fee of Rs. 25,000/- for the registration of applied
product, since the notification for revision of fee vide SRO No. F.7-11/2012-
B&A/DRA was published on 7th May 2021 while this application was received in
R&I section of DRAP after 7th May 2021.
submission of applicable fee that is Rs. 7,500/- for revision of specifications as per

228. Name, address of Applicant / M/s Swiss Pharmaceuticals Pvt Ltd A/159,
Marketing Authorization Holder SITE-II Super Highway Karachi.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No.
22-23, Industrial Triangle Kahuta Road
Islamabad.
☐ Importer
giver)
Copy of agreement for contract manufacturing
of pharmaceutical products between contract
giver and acceptor dated 29-05-2020 is
submitted.
M/s Vision Pharmaceuticals dated 25-03-2022
based on inspection dated 11-02-2019. As per
the certificate, it was valid till 09-05-2022.
Evidence of approval of manufacturing Firm has submitted copy of letter of renewal of
facility DML of M/s Vision Pharmaceuticals DML No
000517 dated 07-06-2021 specifying sterile dry
powder injectable vial (General) section.
☐ Export sale
The proposed proprietary name / brand PTONIX 40mg IV Injection
name
Active Pharmaceutical ingredient (API) Pantoprazole (as sodium)………40mg
per unit
Pharmaceutical form of applied drug White or almost white colored lyophilized
powder
Pharmacotherapeutic Group of (API) PPI
specifications
The status in reference regulatory Protonix IV 40mg (USFDA Approved)
authorities
For generic drugs (me-too status) Zopent Injection by Hilton

Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No.
Islamabad.
product.
for 36 months.
Comparative Dissolution Profile equivalence for their product against Protonix
IV Injection of Pfizer Pharmaceutical
Manufacturer of API M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-23, Industrial
API Lot No. 2008902

Description of Pack
system)
Batch No. 2009714 2009715 2009716
No. of Batches 03
DATA
the firm (if any)
of API manufacturer issued by concerned dated 31-07-2019 of M/s Vision
regulatory authority of country of origin. Pharmaceuticals (DML No. 000806 semi basic)
issued based on inspection dated 11-02-2019
3. Documents for the procurement of API Firm has submitted inventory transfer note from
with approval from DRAP (in case of SAP of the firm dated 08-10-2020 for the same
import). batch.
by attested respective documents like of all batches along with raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
testing
accelerated)
Evaluation by PEC:
The application of the firm for contract manufacturing from M/s Vision Pharmaceuticals (Pvt)
Ltd. Plot No. 22-23, Industrial Triangle Kahuta Road Islamabad was not submitted as per the
guidance document approved by Registration Board. The submitted application was in variation
to the guidance document for various modules, sections and sub sections majorly including
complete module 1, section 3.2.S.4.1, 3.2.S.4.2, 3.2.S.4.3, 3.2.S.4.4, 3.2.S.5, 3.2.P.2.2.1,
3.2.P.2.6, 3.2.P.3.5, 3.2.P.5.1, 3.2.P.5.2, 3.2.P.5.3, 3.2.P.5.4, 3.2.P.6 and 3.2.P.8. Furthermore, it
is also pertinent to mention that the drug product manufacturer has submitted COA of drug
substance which is released on 26-02-2018 and provided batch release certificates of 3 batches
of drug product released on 09-2017 instead of submitting data of same batches as per the
guidance document. Therefore, the firm was advised to resubmit the application compiled in the
light of the guidance document approved by Registration Board so that further evaluation of your
application could be carried out.

In response, the firm has changed drug product specifications from in house to BP without
submission of fee. Firm has also changed the drug substanbce source from Everest Organics
Limited Aroor Village Sadasivapet Mandal Sangareddy District Aroor (V), Sadasivpet(M),
Sangareddy District Telangana India to M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-23,
The response was also evaluated, and the found deficient for various points. The following points
were communicated to the firm.

No
1. Submit label claim of the applied Firm has submitted following label claim
product in line with innovator without submission of fee.
product / reference product along Each vial Contains:
with submission of requisite fee. Pantoprazole (as sodium)………40mg
2. In your initial submission, you have In our previous submission the testing for 3
mentioned in house specifications batches was done on UV, but parallel we
for the drug product, while in the change our Standard Analytical Procedure and
later submission you have mentioned shift our testing method to HPLC.
BP specifications. Justification is Firm has submitted Revised testing method
required in this regard along with which was signed and issued on 31-12-2021.
evidence when you have changed the This method contains HPLC test for assay of
specifications of your already drug product, however, for bulk stage the assay
registered product. method was based on UV.
As per Documents, firm has changed assay
to HPLC method on 31-12-2021 while the
stability data was initiated on October 2020.
Furthermore, firm could not provide any
evidence of intimation to DRAP regarding
revision of the specifications of their already
registered product from in house to BP
specs.
3. In your initial application you have As we have two DMLs one for finished drugs
specified that the source of drug and secod for semi basic dosage forms. The
substance is Everest Organics lyophilized pantoprazole is always procured
Limited Aroor Village Sadasivapet from M/s Vision Pharmaceuticals but the
Mandal Sangareddy District Aroor powder pantoprazole for lyophilization is
(V), Sadasivpet(M), Sangareddy procured from Everest organics limited.
District Telangana India, while in
new submission you have changed
the source to M/s Vision
Pharmaceuticals (Pvt) Ltd. Plot No.
22-23, Industrial Triangle Kahuta
Road Islamabad. Justification is
required in this regard along with
submission of requisite fee.
4. Submit data in section 3.2.S.4.1 and Firm has submitted standard testing method of
3.2.S.4.2 as per the guidance pantoprazole sodium sesquihydrate drug
document approved by Registration substance from Vision Pharmaceuticals dated
Board which specifies that “Copies 29-12-2021. The submitted document does
of the Drug substance specifications not specify whether it is of semi basic DML
and analytical procedures used for or of DML issued by way of formulation.
routine testing of the Drug substance Moreover the specifications are issued on

by both Drug substance & Drug December 2021 while stability batches were
Product manufacturer is required.” manufactured in October 2020.
5. Submit data in section 3.2.S.4.3 as Firm has submitted verification studies dated
per the decision of 293rd meeting of 05-09-2020 based on HPLC method, while as
Registration Board, which states that per the submitted specifications of the drug
“Analytical Method Verification substance, the assay method is based on
studies including specificity, potentiometric titration.
Product manufacturer for both
compendial as well as non-
compendial drug substance(s) shall
be submitted”.
6. The COA of drug substance Firm submitted that it was a typo error.
manufacturer specifies that the Firm has submitted another copy of COA of
material was released on 31-09-2020 the same batch.
while the drug product manufacturer In the newly submitted COA from Vision
has sampled the product on 02-09- Pharmaceuticals (Semi-Basic DML) the batch
2020 and released on 16-09-2020. was released on 31-08-2020 as per In-house
Justification is required in this specification and assay on UV method. While
regard. as per the raw material analysis report from
Vision Pharmaceuticals (Formulation DML),
the batch was released on 16-09-2020 as per
Innovator’s specification and assay on UV
method.
The drug substance specifications, BP
monograph and submitted COA are
contradictory.
7. Justify the use of 10ml water for Firm has submitted that they are using 10ml of
injection as diluent since the 0.9% sodium chloride solution as diluent.
innovator product recommends that However previously the firm has specified
the product should be reconstituted water for injection as the diluent.
with 10ml 0.9% sodium chloride
solution.
8. Submit results of compatibility Firm has not submitted compatabiity study
studies in section 3.2.P.2.6. report instead only submitted a batch release
report.
9. The analytical method and The provided analytical method and
specifications of the drug product specifications of drug product has been
has been generated and signed on 31- submitted is the updated one, replacing the old
12-2021 with a dsscription “this is a version.
new document on this subject” while As per Documents, firm has changed assay
the stability batches were to HPLC method on 31-12-2021 while the
manufactured in September 2020. stability data was initiated on October 2020.
Justify how the submitted Furthermore, firm could not provide any
specifications could be considered evidence of intimation to DRAP regarding
applicable for testing of these revision of the specifications of their already
batches. registered product from in house to BP
specs.
10. Analytical method alidation studies Firm has once again submitted same old
of the drug product were developed verification studies of 2017 in which the
in 2017 wherein the specifications assay method was different from that
and analytical method of BP 2020 specified in the latest specifications of the
were claimed. Justify how validation firm as well as BP monograph.

of analytical method of 2020 can be
performed in 2017.
11. Justify how three batches of drug It was a typo error, updated range was
product with BP specs were released according to BP.
on 05-10-2020 while the drug
specifications are different from that
specified in BP monograph and are
exactly same as that submitted in
initial application as in-house
specifications.
12. Submit evidence of procurement of Firm has submitted inventory transfer note
the drug substance. from SAP of the firm dated 08-10-2020 for the
same batch.
However, the document does not specify any
quantity. Moreover, the document for
transfer of inventory is of 08-10-2020, while
as per the raw material analysis report from
Vision Pharmaceuticals (Formulation
DML), the batch was released on 16-09-
2020.
13. Justify how the manufacturing of The drug substance was released on 07-09-
commercial batches were carried out 2020.
from 17-09-2020 while the drug However as per invoice the material was
substance used in those batches was transferred o 08-10-2020, and as per raw
released on 31-09-2020. material analysis report the material was
released on 16-09-2020.
• Submission of applicable fee for revision of source of drug substance, revision of
specifications and label claim as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
• Scientific justification how a revised HPLC method dated 31-12-2021 can represent
the results of the stability studies which were initiated in October 2020.
• Approval of DRAP for change in specifications of the registered product for which
stability data is submitted.
• Scientific justification for performing verification studies of analytical method of
drug substance dated 05-09-2020 based on HPLC method, while as per the
submitted specifications of the drug substance, the assay method is based on
potentiometric titration.
• Scientific justification for having drug substance specifications which are different
from the specifications of drug substance manufacturer as well as BP monograph.
• Clarification about the use of 10ml water for injection as diluent for the applied
product since the innovator product recommends different diluent.
• Verification studies of the analytical method of drug product.
• Evidence of procurement of the drug substance.
• Scientific justification for manufacturing and testing commercial batches of a
registered drug product on non-pharmacopoeial specifications while BP
monograph was already available for the drug product.
229. Name, address of Applicant / M/s Martin Dow Limited, Plot No. 37, Sector
Marketing Authorization Holder 19, Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No.
Islamabad.

☐ Importer
giver)
Copy of agreement for contract manufacturing
of pharmaceutical products between contract
giver and acceptor dated 02-08-2021 is
submitted.
M/s Vision Pharmaceuticals dated 25-03-2022
based on inspection dated 11-02-2019. As per
the certificate, it was valid till 09-05-2022.
Evidence of approval of manufacturing Firm has submitted copy of letter of renewal of
facility DML of M/s Vision Pharmaceuticals DML No
000517 dated 07-06-2021. Firm has also
submitted copy of letter dated 09-12-2021
which specifies that CLB in its 283rd meeting
held on 28th October 2021 also approved
renewal of DML for Liquid Injectable (LVP)
General Section.
☐ Export sale
The proposed proprietary name / brand JYTHON 600mg/300ml Infusion
name
Strength / concentration of drug of Each vial of 300ml Contains:
Active Pharmaceutical ingredient (API) Linezolid…..…600mg
per unit
Pharmaceutical form of applied drug Liquid infusion
Pharmacotherapeutic Group of (API) Antibacterials for systemic use
Reference to Finished product In-house specs
specifications
The status in reference regulatory Zyvox IV (USFDA Approved)
authorities
For generic drugs (me-too status) Nezkil Infusion by Continental pharma
Name and address of API manufacturer. Optrix Laboratories Pvt Ltd. Survey No. 145/A
& 147, Ramalingampally (V),
Bommalaramaram (M), Yadadri-Bhuvanagiri
District Telangana India.

product.
for 24 months.
Comparative Dissolution Profile equivalence for their product against Nezkil
infusion of Continental Pharma.
Manufacturer of API Optrix Laboratories Pvt Ltd. Survey No. 145/A & 147,
Ramalingampally (V), Bommalaramaram (M), Yadadri-
Bhuvanagiri District Telangana India.
API Lot No. OP-LID/10/17/107
Description of Pack
(Container closure Glass vials
system)

Batch No. 1217901 1217902 1217904
No. of Batches 03
DATA
the firm (if any)
of API manufacturer issued by concerned (No. 68951/TS/2021) issued by Drugs control
regulatory authority of country of origin. administration, Government of Telangana dated
20-09-2021. The GMP certificate is valid till 19-
09-2022.
with approval from DRAP (in case of cleared dated 08-11-2017 specifying import of
import). 50Kg Linezolid. The invoice is cleared by AD
(I&E) DRAP.
by attested respective documents like of all batches along with raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software Not applicable. Our HPLC system are not 21
21CFR & audit trail reports on product CFR compliant.
testing
accelerated)
Evaluation by PEC:

No
1. Justify the manufacturing of 300ml Firm has also submitted copy of letter dated
glass vial (linezolid 600mg/300ml 09-12-2021 which specifies that CLB in its
Infusion), while your approved 283rd meeting held on 28th October 2021 also
manufacturing facility is “Liquid approved renewal of DML for Liquid
Injectable Vial SVP (General) Injectable (LVP) General Section.
section”.
2. The drug substance manufacturer The drug substance testing was done by UV
has specified HPLC test for assay of method at that time, but currently we are using
drug substance while the drug HPLC method for both API and product.
product manufacturer has specified
UV method for assay of drug
substance. Justify how drug product

manufacturer can adopt different test
for assay method from that
recommended by the drug substance
manufacturer.
3. Submit COA of relevant batch of Firm has submitted ADC attested commercial
API used in the manufacturing of invoice for lot number OP-LID/10/17/107.
batches for which stability study data
is submitted in section 3.2.P.8.3 from
both drug substance manufacturer as
well as drug product manufacturer in
section 3.2.S.4.4, since you have
submitted COA of batch number OP-
LID/10/17/107 (Mfg date: 09-2017),
while as per the submitted import
documents the lot number of the API
is OP-LID/07/18/077 (Mfg date: 05-
2018) and the three stability batches
are manufactured in 12-2017.
4. Innovator drug product is using For pH adjustment we had mentioned HCL and
sodium hydroxide and/or sodium hydroxide in BMR. As our formulation
hydrochloric acid for ataining the pH is stable and upon manufacturing the pH comes
within a narrow range of 4.4-5.2 in limit as defined, and we do not require HCl
while your master formulation does or Sodium hydroxide for pH adjustment.
not specify the use of any such
ingredient. Justification is required
in this regard.
5. Justify why the pharmaceutical Pharmaceutical equivalence study was done
equivalence studies were conducted against Nezkil of continental pharma as
against the comparator product mentioned in DRAP 293rd meeting we can use
instead of using innovator / reference Reference or comparator product for
product. Further justify why comparison and comparator product is among
pharmaceutical equivalence does not brand leaders in Pakistan.
include all quality tests.
6. The pH of the product mentioned in It was a typo error. Actual pH range is 4.4 to
section 3.2.P.2.6 is 6.12 with a range 5.5 and our results fall in it.
of 5.0 to 7.0 which is contrary to the
limit defined in your speifications.
Justification is required in this
regard.
7. Justify why terminal sterilization is Firm has submitted that they have performed
not performed for the said product terminal sterilization and have also submitted
although being the method of choice copy of BMR.
for sterilization.
8. Justify why the test for filled volume Filled volume test reports are now provided by
is not specified in the specifications the firm.
of the drug product although this test
is recommended in general
monograph of official
pharmacopoeia.
9. Justify the pH of the drug product Linezolid infusion batches kept on stability
from 4.4 to 5.5 since the pH range have pH almost in the range of 4.4 to 4.8, and
recommended by the innovator’s this is in limit of 4.4 to 5.2, However we will
product is 4.4-5.2. revise the pH limit as according to innovator
specs and will revise the testing SOP.

10. Justify the analytical method for Firm has submitted revised analytical
assay testing of the drug product procedures of the drug product dated 13-09-
which is based on UV method since 2021. As per the method, buk product is tested
the innovator’s product as well as the
by UV method while filled vial are tested using
drug substance manufacturer specify HPLC method.
HPLC method for assay test. The revised method is signed on 13-09-2021
while the stability studies were initiated on
December 2017.
11. The container closure system of the Stability is done in glass vial and it is stable.
innovator is “flexible plastic infusion Also our glass vials are wrapped in laminated
bags in a foil laminate overwrap” foil.
while your prduct is packed in glass
vial. Justify how your container
closure system can prevent the
product from exposure to the light.
12. Justify why the test of pH is not pH is not included in stability summary sheets,
performed during stability studies. however all testing is performed and
mentioned in analysis certificates. pH results
added in stability summary sheet.
• Scientific justification for revised analytical procedures of the drug product dated
13-09-2021 in which buk product is tested by UV method while filled vial are tested
using HPLC method.
• Scientific justification how a revised method dated 13-09-2021 can represent the
results of the stability studies which were initiated in December 2017.
230. Name, address of Applicant / M/s Genetics Pharmaceuticals (Pvt) Ltd.

Marketing Authorization Holder 539-A, Sundar Industrial Estate, Raiwind
Road Lahore.
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt) Ltd.
Plot No. 81, Sunder Industrial Estate, Lahore.
☐ Importer
giver)
manufacturing agreement with applicant firm
dated 29-03-2021.
M/s Cunningham Pharmaceuticals (Pvt) Ltd
dated 19-04-2019 based on the inspection dated
01-04-2019.
The GMP certificate specifies Dry powder
suspension (cephalosporin) section.
Evidence of approval of manufacturing Firm has submitted copy of letter for issuance
facility of DML of M/s Cunningham Pharmaceuticals
(Pvt) Ltd dated 13-06-2016 specifying Dry
powder suspension (cephalosporin) section.

☐ Export sale
PKR 25,000/-: 26-05-2021
The proposed proprietary name / brand GENFIXIM 100mg/5ml Dry Suspension
name
Strength / concentration of drug of Each 5ml of reconstituted suspension Contains:
Active Pharmaceutical ingredient (API) Cefixime as trihydrate………100mg
per unit
Pharmaceutical form of applied drug White to light yellow powder filled in amber
colored glass bottle
specifications
Proposed Pack size 30 ml
The status in reference regulatory Cefixime suspension (USFDA Approved)
authorities
For generic drugs (me-too status) Cefim suspension by Hilton
Name and address of API manufacturer. Pharmagen Limited. Kot Nabi Bukshwala, 34
product.

for 36 months.
product against Cebosh dry suspension of
Manufacturer of API Pharmagen Limited. Kot Nabi Bukshwala, 34 Km, Ferozepur Road,
Lahore.
API Lot No. 00243/342/2017
Description of Pack
(Container closure Amber color glass bottle
system)
Batch No. 180012 180013 180015
No. of Batches 03
DATA
1. Reference of previous approval of No previous PSI has been conducted
the firm (if any)
of API manufacturer issued by concerned issued by Additional Director DRAP, dated 11-
regulatory authority of country of origin. 01-2019. The GMP certificate was granted
based on inspection dated 08-01-2019.

with approval from DRAP (in case of dated 09-02-2018 specifying purchase of 25Kg
import). Cefixime (micronized).
4. Data of stability batches will be supported Firm has submitted record of testing of all
by attested respective documents like batches along with raw data sheets, HPLC
chromatograms, Raw data sheets, COA, chromatograms, COA and summary data
testing
accelerated)
Evaluation by PEC:
Sr. Shortcomings Communicated Response by the firm

No
3.2.S.4.2 as per the guidance document specifications from API manufacturer as
approved by Registration Board which well as Cunningham pharmaceuticals
specifies that “Copies of the Drug dated February 2021.
substance specifications and analytical The specifications of Cunningham
procedures used for routine testing of pharma are different from API
the Drug substance /Active manufacturer as well as BP monograph.
Pharmaceutical Ingredient by both Drug Further the API specs are of February
substance & Drug Product 2021 while stability testing was initiated
manufacturer is required.” in March 2018.
2. Submit data of verification of analytical Firm has submitted verification studies of
procedure of drug substance in section analytical method of drug substance.
3.2.S.4.3 as per the guidance document The analytical method mentioned in
approved by Registration Board and in verification studies is different from the
line with ICH guidelines specifying the analytical procedure submitted in section
exact concentration of each solution and 3.2.S.4.2. Furthermore the method
the detailed procedure for each test. specifies HPLC technique while the
calculation method specifies UV
absorbance values.
substance and drug product.
4. Submit stability study data of the drug Firm has again submitted the same stability
substance (cefixime trihydrate in data without clarification whether the
micronized form) from the drug cefixime was compacted or micronized.
substance manufacturer as per zone IV-
A conditions.
5. Provide complete master formulation Firm has submitted master formulation per
for each bottle in section 3.2.P.1. bottle.
6. Provide details of reconstitution solvent Water for injection 20ml is the diluent for
/ diluent along with its exact volume reconstitution.
which is to be used for reconstitution of
the drug product.

7. Justify why the pharmaceutical No response submitted by the firm, firm
equivalence studies are not performed has again submitted the same
against the innovator / reference pharmaceutical equivalence report.
product. Firm has not performed preservative
effectiveness studies.
8. Justify why comparative dissolution Firm has submitted that test for CDP is not
profile / drug release studies are not mentioned in USP monograph.
performed for your product since
USFDA has recommended such studies
for cefixime suspension.
9. Submit data of compatibility of the drug Firm has submitted results of compatibility
product along with reconstitution studies.
solvent in section 3.2.P.2.6.
10. Justify why the test for deliverable Firm has submitted revised specifications
volume is not added in drug product in which test of deliverable volume is also
specification as recommended in USP added. Firm has not submitted any fee for
monograph. Revise your product change of specifications.
specifications in line with USP
monograph along with submission of
fee for revision of specifications.
11. Provide details about the standard Firm has submitted revised specifications
solution preparation instead of just in which detailed method of standard
using the general statement “0.2mg/ml solution preparation is mentioned.
of USP cefixime RS in solution C” as
mentioned in USP monograph.
12. Submit exact details of the assay Firm has submitted revised specifications
preparation since the words in which detailed method of sample
“Reconstitute sample as directed n the solution preparation is mentioned.
labelling” should not be used in the
method adopted by a firm. Instead
provide details about the exact diluent
along with volume in which
reconstitution is to be carried out.
13. Justify the alternate method for assay Firm has submitted that UV method is only
testing of the drug product which is for final mix stage in order to save time
based on UV analysis. during the process.
14. The concentration of standard solution Method verification of finished product has
is 0.2mg/ml while your linearity studies been revised as per ICH guidelines.
are conducted between 0.008mg/ml to Firm has not justified previous
0.02mg/ml in which does not include verification studies.
the concentration of standard solution.
Justify your results.
15. The repeatability, reproducibility and Method verification of finished product has
accuracy studies are reported without been revised as per ICH guidelines.
specifying the exact concentration of Firm has not justified previous
each solution which is tested. Provide verification studies.
results of your verification studies in the
light of ICH guidelines.
16. Justify how same verification studies Method verification of finished product has
are used for the analytical method of been revised as per ICH guidelines.
cefixime capsule, and suspension as Firm has not justified previous
well. verification studies.
17. For Batch No. 180012, the results of It was a typographical error.
batch analysis (performed on 19-02-
2018) was 109.86% while the results in

initial stability studies at accelerated
(performed on 22-03-2018) was
102.65% while the results in initial
stability studies at real time (performed
on 22-03-2018) was 104.71%. Justify
how such significant difference in assay
value exists and further justify how the
results of initial stability is different for
accelerated and real time studies.
18. For Batch No. 180013, the results of It was a typographical error.
batch analysis (performed on 22-02-
2018) was 104.71% while the results in
initial stability studies at accelerated
(performed on 19-03-2018) was
101.23% while the results in initial
stability studies at real time (performed
on 19-03-2018) was 104.62%. Justify
how such significant difference in assay
value exists and further justify how the
results of initial stability is different for
accelerated and real time studies.
19. Specify the date of initiation of stability 19-04-2018
studies for the batch number 180015.
• Scientific justification for having different specifications of the drug substance from
that of API manufacturer as well as BP monograph.
• Scientific justification how a revised method of February 2021 can represent the
results of the stability studies which were initiated in March 2018.
• Scientific justification for performing verification studies of the analytical method
of drug substance using a different analytical method from that specified in section
3.2.S.4.2.
• Submission of stability study data of three batches of cefixime trihydrate
(micronized) from the API manufacturer as per zone IV-A conditions.
• Submission of pharmaceutical equivalence and Comparative Dissolution Profile
(CDP) against the innovator’s product.
• Submission of preservative effectiveness studies.
• Submission of applicable fee for revision of specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
• Scientific justification how the results of at zero month time point can be different
for accelerated and real time conditions.
Road Lahore.
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt) Ltd.
Plot No. 81, Sunder Industrial Estate, Lahore.
☐ Importer
giver)
dated 29-03-2021.

M/s Cunningham Pharmaceuticals (Pvt) Ltd
dated 19-04-2019 based on the inspection dated
01-04-2019.
The GMP certificate specifies Dry powder
suspension (cephalosporin) section.
Evidence of approval of manufacturing Firm has submitted copy of letter for issuance
facility of DML of M/s Cunningham Pharmaceuticals
(Pvt) Ltd dated 13-06-2016 specifying Dry
powder suspension (cephalosporin) section.
☐ Export sale
PKR 25,000/-: 26-05-2021
The proposed proprietary name / brand GENFIXIM 200mg/5ml Dry Suspension
name
Strength / concentration of drug of Each 5ml of reconstituted suspension Contains:
Active Pharmaceutical ingredient (API) Cefixime as trihydrate………200mg
per unit
Pharmaceutical form of applied drug White to light yellow powder filled in amber
colored glass bottle
specifications
Proposed Pack size 30 ml
The status in reference regulatory Cefixime suspension (USFDA Approved)
authorities
For generic drugs (me-too status) Cefim suspension by Hilton
product.

for 36 months.
product against Cebosh dry suspension of
Lahore.
API Lot No. 00243/342/2017
Description of Pack
(Container closure Amber color glass bottle
system)
Batch No. 180011 180016 180048

No. of Batches 03
DATA
1. Reference of previous approval of No previous PSI has been conducted
the firm (if any)
of API manufacturer issued by concerned issued by Additional Director DRAP, dated 11-
regulatory authority of country of origin. 01-2019. The GMP certificate was granted
based on inspection dated 08-01-2019.
with approval from DRAP (in case of dated 09-02-2018 specifying purchase of 25Kg
import). Cefixime (micronized).
4. Data of stability batches will be supported Firm has submitted record of testing of all
by attested respective documents like batches along with raw data sheets, HPLC
chromatograms, Raw data sheets, COA, chromatograms, COA and summary data
testing
accelerated)
Evaluation by PEC:
Sr. Shortcomings Communicated Response by the firm

No
3.2.S.4.2 as per the guidance documentspecifications from API manufacturer as
approved by Registration Board which well as Cunningham pharmaceuticals
specifies that “Copies of the Drug dated February 2021.
The specifications of Cunningham
procedures used for routine testing ofpharma are different from API
manufacturer as well as BP monograph.
Pharmaceutical Ingredient by both DrugFurther the API specs are of February
substance & Drug Product
2021 while stability testing was initiated
manufacturer is required.” in March 2018.
2. Submit data of verification of analytical
Firm has submitted verification studies of
procedure of drug substance in sectionanalytical method of drug substance.
3.2.S.4.3 as per the guidance documentThe analytical method mentioned in
approved by Registration Board and in verification studies is different from the
line with ICH guidelines specifying the
analytical procedure submitted in section
exact concentration of each solution and
3.2.S.4.2. Furthermore the method
the detailed procedure for each test. specifies HPLC technique while the
calculation method specifies UV
absorbance values.

4. Submit stability study data of the drug Firm has again submitted the same stability
substance (cefixime trihydrate in data without clarification whether the
micronized form) from the drug cefixime was compacted or micronized.
substance manufacturer as per zone IV-
A conditions.
5. Provide complete master formulation Firm has submitted master formulation per
for each bottle in section 3.2.P.1. bottle.
6. Provide details of reconstitution solvent Water for injection 20ml is the diluent for
/ diluent along with its exact volume reconstitution.
which is to be used for reconstitution of
the drug product.
7. Justify why the pharmaceutical As innovator product is not available in
equivalence studies are not performed Pakistan therefore we performed testing
against the innovator / reference against Cebosh suspension.
product. Firm has not performed preservative
effectiveness studies.
8. Justify why comparative dissolution Firm has submitted that test for CDP is not
profile / drug release studies are not mentioned in USP monograph.
performed for your product since
USFDA has recommended such studies
for cefixime suspension.
9. Submit data of compatibility of the drug Firm has submitted results of compatibility
product along with reconstitution studies.
solvent in section 3.2.P.2.6.
10. Justify why the test for deliverable Firm has submitted revised specifications
volume is not added in drug product in which test of deliverable volume is also
specification as recommended in USP added. Firm has not submitted any fee for
monograph. Revise your product change of specifications.
specifications in line with USP
monograph along with submission of
fee for revision of specifications.
11. Provide details about the standard Firm has submitted revised specifications
solution preparation instead of just in which detailed method of standard
using the general statement “0.2mg/ml solution preparation is mentioned.
of USP cefixime RS in solution C” as
mentioned in USP monograph.
12. Submit exact details of the assay Firm has submitted revised specifications
preparation since the words in which detailed method of sample
“Reconstitute sample as directed n the solution preparation is mentioned.
labelling” should not be used in the
method adopted by a firm. Instead
provide details about the exact diluent
along with volume in which
reconstitution is to be carried out.
13. Justify the alternate method for assay Firm has submitted that UV method is only
testing of the drug product which is for final mix stage in order to save time
based on UV analysis. during the process.
14. The concentration of standard solution Method verification of finished product has
is 0.2mg/ml while your linearity studies been revised as per ICH guidelines.
are conducted between 0.008mg/ml to Firm has not justified previous
0.02mg/ml in which does not include verification studies.
the concentration of standard solution.
Justify your results.
15. The repeatability, reproducibility and Method verification of finished product has
accuracy studies are reported without been revised as per ICH guidelines.

specifying the exact concentration of Firm has not justified previous
each solution which is tested. Provide verification studies.
results of your verification studies in the
light of ICH guidelines.
16. Justify how same verification studies Method verification of finished product has
are used for the analytical method of been revised as per ICH guidelines.
cefixime capsule, and suspension as Firm has not justified previous
well. verification studies.
17. Justify how the results of initial stability
Results of initial stability study are not
is different for accelerated and real time
different from accelerated and real time
studies. time studies. However, it was a
typographical error. Results of Batch
180016 and Batch 180048 after correction
are attached.
18. Justify why the results of real time It was a typographical error. Results of
stability studies for batch 180016 and Batch 180016 and Batch 180048 after
180048 are exactly same. correction are attached.
• Scientific justification for having different specifications of the drug substance from
that of API manufacturer as well as BP monograph.
• Scientific justification how a revised method of February 2021 can represent the
results of the stability studies which were initiated in March 2018.
• Scientific justification for performing verification studies of the analytical method
of drug substance using a different analytical method from that specified in section
3.2.S.4.2.
• Submission of stability study data of three batches of cefixime trihydrate
(micronized) from the API manufacturer as per zone IV-A conditions.
• Submission of pharmaceutical equivalence and Comparative dissolution profile
(CDP) against the innovator’s product.
• Submission of preservative effectiveness studies.
• Submission of applicable fee for revision of specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
• Scientific justification how the results of initial stability can be different for
accelerated and real time conditions.
232. Name, address of Applicant / Mar M/s Islam Pharmaceuticals. 7 km, Pasrur
keting Authorization Holder Road, Sialkot
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial
☐ Importer
giver)
dated 15-06-2019.
M/s Bio-Labs dated 21-05-2019 based on the
The GMP certificate specifies dry powder
injection (cephalosporin) section.

Evidence of approval of manufacturing Firm has submitted copy of GMP certificate of
facility M/s Bio-Labs dated 21-05-2019 based on the
The GMP certificate specifies dry powder
injection (cephalosporin) section.
Firm has also submitted copy of letter for grant of
additional section dated 27-02-2011 specifying
dry powder injection (cephalosporin).
☐ Export sale
The proposed proprietary name / brand TYRONE 500mg Injection
name
Pharmaceutical ingredient (API) per unit Cefotaxime (as sodium)……500mg
Pharmaceutical form of applied drug Sterile white to off white powder filled in
transparent glass vials
Reference to Finished product Innovator’s
specifications
The status in reference regulatory Cefotaxime sodium Injection (MHRA
For generic drugs (me-too status) Claforan injection by Sanofi Aventis
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical Co. Ltd. 849
Dongjia Town, Licheng District Jinan City PR
China.
product.

stability data is conducted at 40oC ± 2oC / 75% ±
is conducted at 30oC ± 2oC / 65% ± 5% RH for 24
months.
and stability.
against the comparator i.e. Claforan 500mg
Injection.
Manufacturer of API Qilu Antibiotics Pharmaceutical Co. Ltd. 849 Dongjia Town, Licheng
District Jinan City PR China.
Description of Pack
Glass vials
Batch No. VP-01712 VP-1511 VP-1626
Batch Size 16,000 vials 4000 vials 3100 vials
No. of Batches 03

1. Reference of previous approval of Firm has refered to their previous inspection
applications with stability study data of the conducted for Empaglif 10mg Tablet
firm (if any) (Empagliflozin) & Empaglif 25mg Tablet which
was considered by the Board in its 296th meeting
and the product was approved based on the
inspection report. Following points were noted
during the inspection:
• All the stability study of EMPAGLIF (10mg &
25mg) Tablets has been conduct on Shimadzu
HPLC (Model SPD-20) operated via
LABSOLUTION software version 6.5
(complying FDA 21 CFR part 11)
• Audit trail reports for Testing of Empaglif 10mg
& 25mg Tablets are available.
Proper and continuous monitoring record for
stability chamber is available, along with 5KV
backup generator with ATS.
API manufacturer issued by concerned SD20170590) issued by CFDA China dated 31-
regulatory authority of country of origin. 07-2017. The GMP certificate is valid till 30-07-
2022.
by attested respective documents like all batches along with chromatograms, raw data
chromatograms, Raw data sheets, COA, sheets, COA and summary data sheets.
testing
accelerated)
Evaluation by PEC:
Firm has initially submitted drug substance data of Qilu Antibiotics Pharmaceutical Co. Ltd. China,
later on the firm revised API source to Nectar life sciences. Firm has not submitted any justification
or fee for revision of source of API.
Sr. No Shortcomings Communicated Response by the firm

1. Submit differential fee for the registration Firm has submitted fee 25,000 vide slip
of applied product, since the notification number 44849567547 dated 21-02-2022.
for revision of fee vide SRO No. F.7-
11/2012-B&A/DRA was published on 7th
May 2021 while this application was
received in R&I section of DRAP after 7th
May 2021.
2. You have submitted Innovator’s Innovator’s specs was written mistakenly in
specification in module 1 while the Form 5-F. Rest of the dossier is of USP specs.
product monograph is available in USP, Firm has not submitted any fee for
revise the specifications along with correction in Specs

3. Submit data in section 3.2.S.4.1 and Firm has not submitted any justification.
3.2.S.4.2 as per the guidance document
approved by Registration Board which
specifies that “Copies of the Drug
4. Justify how you have used drug substance Firm has not submitted any justification.
to manufacture cefotaxime injection with
USP specifications in which the drug
substance is being tested using different
mobile phase as that recommended in
USP.
5. Submit data in section 3.2.S.4.3 as per the Run time 9 min against USP which say 56
decision of 293rd meeting of Registration mins
Board, which states that “Analytical
Method Verification studies including
Further justify how the analysis of drug
substance was conducted without
performing verification studies of the
analytical method of drug substance.
6. Justify how the drug product Sterility and bacterial endotoxin was
manufacturer i.e. M/s Bio labs released performed at the material testing time but
drug substance (lot No. 0046L81F) on 08- mistakenly not mentioned in COA. Now we
03-2021 without the test for sterility and are submitting COA of lot number which was
bacterial endotoxin, since all of these tests actually used in drug product.
are mentioned in drug substance
specifications as well as in the COA of
drug substance manufacturer.
7. Submit data in section 3.2.S.4.4 as per the We didn’t cross check and submit same
guidance document approved by batches COA earlier. Now are providing
Registration Board which specifies that relevant batches COAs
“Provide results of analysis of relevant The new COA are from different source
during product development and stability
studies, along with Certificate of Analysis
(CoA) of the same batch from Drug
Substance / /Active Pharmaceutical
Ingredient manufacture, since the
submitted COA of API are of 2021 while
the drug product batches were
manufactured in 2018.
8. The acceptance criteria for assay test in Firm has not submitted any justification.
the drug substance specifications
(3.2.S.4.1) is 96 – 102% while the
acceptance criteria in COA is 91.6 –
96.4%.

9. Provide COA of reference standard which Firm has submitted their own in house
is actually used in the analysis of drug generated COA for working standard taken
substance in section 3.2.S.5. from commercial lot.
10. Submit master formulation including Firm has submitted theoretical fill weight per
theoretical fill weight per vial in section vial
3.2.P.1.
11. Justify why the pharmaceutical Firm has not submitted any justification.
equivalence study does not include
complete testing of the drug product and
the innovator product as per USP
specifications. Justify how only pH and
assay test can demonstrate
pharmaceutical equivalence.
12. Justify your process validation protocols Firm has not submitted any justification.
and report without any process for
optimization of sterilization process and
sealing of vials etc.
13. Justify why the specifications of the drug Firm has not submitted any justification.
product (section 3.2.P.5.1) does not
contain complete tests as recommended
by USP.
14. Provide detailed testing method for the Still not complete, formula is diff
applied drug product instead of
submitting copy of USP monograph.
15. Specify the exact details of the accuracy Firm has submitted concentrations for each
and recovery test including the details of percentage used in accuracy studies.
exact concertation of 50%, 100% and
150% solutions.
16. Justify the verification studies in which We have followed USP criteria and on this
the chromatogram run is till 10 minutes criteria peak arises at about 5.2 minutes. So
since the gradient HPLC testing till 56 the routine adjusted around 10 minutes to
minutes is recommended in USP safe the time upto 56 minutes.
monograph. USP recommends the mobile phase as under:
Time Solution A Solution B
(%) (%)
0 100 0
7 100 0
9 80 20
16 80 20
46 0 100
51 0 100
56 100 0
17. Submit the results of verification studies Firm has again submitted verification studies
of analytical method of drug product in results.
the light of ICH guidelines, since the
submitted studies are not exactly as per
ICH guidelines.
18. Justify how three commercial batches Complete testing was performed as per USP
were released for commercial use without monograph although COA that provided
performing complete tests as specified in does not include all performed test
USP monograph. parameter. Now COA is revised according to
specifications

19. Provide COA of reference standard Firm has submitted their own in house
actually used in the analysis of drug generated COA for working standard taken
product in section 3.2.P.6. from commercial lot.
20. Justify why the stability study data of We didn’t cross check and submit same
three different batches is submitted from batches COA earlier. Now are providing
those for which batch analysis is provided relevant batches COAs
in section 3.2.P.5.4.
21. Specify the exact API lot number and Drug substance B#CFT101029217N COA is
source of API used in the manufacturing attached
of each batch of drug product. The drug substance manufacturer is
changed.
22. Justify the difference in batch size ranging Firm has not submitted any justification.
from 3100 vials to 16000 vials.
23. Justify why in-use stability study is not Firm has not submitted any justification.
performed.
24. Justify why the test for water contents, Test for water content and constituted
constituted solution etc is not performed solution is performed at stability testing. test
during stability studies since these tests was missing in report.
are very critical and are required to make
assessment of the stability profile and
shelf life.
25. Provide raw data sheets to justify the The submitted stability data is performed
calculation of results for assay testing at using analytical method which is not as per
each time point during the stability testing USP monograph.
of each batch.
26. Justify how assay testing was conducted By considering this deficiency, it is noted that
using only 3 analysis of standard solution. 3 standards are performed in assay. The
reason by using 3 standard are considering
with the USP monograph 621 which states
that RSD will be with in range i.e; NMT 2%.
27. How you have performed assay testing We have followed USP criteria and on this
throughout the stability studies in which criteria peak arises at about 5.2 minutes. So
the chromatogram run is till 10 minutes the routine adjusted around 10 minutes to
since the gradient HPLC testing till 56 safe the time upto 56 minutes.
minutes is recommended in USP
monograph.
• Submission of applicable fee for revision of source of drug substance and revision of
• Submission of copies of the Drug substance specifications and analytical procedures
used for routine testing of the Drug substance /Active Pharmaceutical Ingredient by
both Drug substance & Drug Product manufacturer.
• Scientific justification for having drug substance specification which is different from
USP monograph in terms of mobile phase.
• Scientific justification for verification studies of analytical procedure of drug substance
in which the HPLC run time is 9 minutes while USP monograph recommends run time
for 56 minutes.
• Submission of results of analysis of relevant batch(es) of Drug Substance performed by
Drug Product manufacturer used during product development and stability studies,
along with Certificate of Analysis (CoA) of the same batch from Drug Substance
manufacturer.
• Scientific justification for having acceptance criteria for assay test in the drug substance
specifications (3.2.S.4.1) is 96 – 102% while the acceptance criteria in COA is 91.6 –
96.4%.

• Scientific justification why the pharmaceutical equivalence study does not include
complete testing of the drug product and the innovator product as per USP
specifications.
• Scientific justification for process validation protocols and report without any process
for optimization of sterilization process and sealing of vials etc.
• Scientific justification why the specifications of the drug product (section 3.2.P.5.1) does
not contain complete tests as recommended by USP. Further justify why the calculation
formula for assay testing is different from that recommended in USP.
• Scientific justification for verification studies of the drug product in which HPLC run
time is for 10 minutes while USP recommends run time for 56 minutes.
• Scientific justification for having batch size of commercial product ranging from 3100
vials to 16000 vials.
• Scientific justification why in-use stability study of the drug product is not performed.
• Scientific justification for testing commercial batches of registered product using the
analytical procedure which is different from USP monograph in terms of mobile phase,
run time and calculation formula.
233. Name, address of Applicant / M/s Valor Pharmaceuticals. 124/A Industrial

Marketing Authorization Holder Triangle, Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Biogen Pharmaceuticals 8Km, Chakbeli
Road Rawat, Rawalpindi
☐ Importer
giver)
2020.
facility letter dated 14-02-2020 which specifies Dry Vial
section (Cephalosporin).
☐ Export sale
The proposed proprietary name / brand ROVITROX 250mg Injection IM
name
Pharmaceutical form of applied drug Sterile white to off white / yellowish crystalline
powder filled in transparent glass vials
specifications

Name and address of API manufacturer. Pharmagen Ltd. Kot Nabi Buksh Wala 34-Km,
Ferozepur Road, Lahore.
product.
months.
stability.
Firm has also submitted compatibility studies of
the drug product along with the recommended
diluent i.e. 1% lignocaine hydrochloride
injection.
USP for their product against the comparator i.e.

Rocephin 250mg Injection of M/s Roche
Pakistan.
Lahore.
API Lot No. 00421/002/2019
Description of Pack
Glass vials
Batch No. 001 002 003
No. of Batches 03
firm (if any)
API manufacturer issued by concerned by Additional Director DRAP, Lahore dated 11-
regulatory authority of country of origin. 01-2019. The GMP certificate was granted based
on inspection dated 08-01-2019.
approval from DRAP (in case of import). specifying import of 10Kg Ceftriaxone sodium
(sterile) dated 19-02-2020.
5. Compliance Record of HPLC software Firm has submitted that their HPLC system is not
21CFR & audit trail reports on product 21 CFR compliant.
testing
accelerated)
Evaluation by PEC:

Firm was asked to submit the following:
• Submit valid contract manufacturing agreement between the contract giver and contract
acceptor.
• Submit product development and stability study data of commercial batches manufactured by
the drug product manufacturer, since the submitted data are of trial batches.
The firm submitted its response (Dy No. 6985) dated 14-03-2022 submitted the following data:
Manufacturer of API Sinopharm Weiqida Pharmaceutical Co. Ltd. First Medical Zone,
Economic and Technological Development Zone, Datong Shanxi.
China.
API Lot No. Q012105004
Description of Pack
Glass vials
Batch No. 21H015 21H019 21H037
No. of Batches 03
firm (if any)
API manufacturer issued by concerned SX20180229) issued by CFDA China dated 06-
2023.
approval from DRAP (in case of import). cleared dated 28-06-2021 specifying import of
150Kg Ceftriaxone sodium (sterile). The invoice
was cleared by AD (I&E).
testing

accelerated)
Evaluation by PEC:
• Firm has changed the source of drug substance from Pharmagen limited to Sinopharm
Weiqida.
• Firm has submitted copy of BMR of commercial batches.
• Firm has not submitted fee for change of API source and stability study data.
Decision: Approved.
submission of applicable fee for change of source of drug substance as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
234. Name, address of Applicant / Mar M/s Valor Pharmaceuticals. 124/A Industrial
keting Authorization Holder Triangle, Kahuta Road Islamabad.
☐ Importer
giver)
2020.
☐ Export sale
The proposed proprietary name / brand ROVITROX 500mg Injection IM
name
specifications

product.
months.
stability.
diluent i.e. 1% lignocaine hydrochloride
injection.
Rocephin 500mg Injection of M/s Roche
Pakistan.

Lahore.
API Lot No. 00421/002/2019
Description of Pack
Glass vials
Batch No. 001 002 003
No. of Batches 03
firm (if any)
testing
accelerated)
Evaluation by PEC:
Firm was asked to submit the following documents:

• Submit valid contract manufacturing agreement between the contract giver and contract
acceptor.
the drug product manufacturer, since the submitted data are of trial batches.
China.
Description of Pack
Glass vials
Batch No. 21H016 21H017 21H038
No. of Batches 03
firm (if any)
2023.
testing
time and accelerated stability chambers.

accelerated)
Evaluation by PEC:
Weiqida.
Decision: Approved.
submission of applicable fee that is 75,000/- for change of source of drug substance as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Rawat, Rawalpindi
☐ Importer
giver)
dated 17-12-2020.
2020.
☐ Export sale
The proposed proprietary name / brand ROVITROX 1g Injection IV
name
specifications

product.
months.
stability.
diluent i.e. water for injection.
Rocephin 1g Injection of M/s Roche Pakistan.

Lahore.
API Lot No. 00421/002/2019
Description of Pack
Glass vials
Batch No. 001 002 003
No. of Batches 03
firm (if any)
testing
accelerated)
Evaluation by PEC:

• Firm was asked to submit product development and stability study data of commercial batches
manufactured by the drug product manufacturer as per the decision of 312nd meeting of
Registration Board, since the submitted data was of trial batches.
China.
Description of Pack
Glass vials
Batch No. 21H020 21H022 21H023
No. of Batches 03
firm (if any)
2023.
testing
accelerated)

Evaluation by PEC:
Weiqida.
Decision: Approved.
submission of applicable fee that is 75,000/- for change of source of drug substance as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Rawat, Rawalpindi
☐ Importer
giver)
dated 25-03-2021.
2020.
☐ Export sale
The proposed proprietary name / brand ROVITROX 2g Injection IV
name
specifications

product.
months.
stability.
diluent i.e. water for injection.
Rocephin 2g Injection of M/s Roche Pakistan.

Lahore.
API Lot No. 00421/002/2019
Description of Pack
Glass vials
Batch No. 001 002 003
No. of Batches 03
firm (if any)
testing
accelerated)
Evaluation by PEC:
Firm was asked to submit the following:
revision of fee vide SRO No. F.7-11/2012-B&A/DRA was published on 7th May 2021 while
this application was received in R&I section of DRAP after 7th May 2021.

the drug product manufacturer as per the decision of 312nd meeting of Registration Board,
since the submitted data are of trial batches.
China.
Description of Pack
Glass vials
Batch No. 21H043 21H044 21H045
No. of Batches 03
firm (if any)
2023.
testing
accelerated)

Evaluation by PEC:
Weiqida.
Decision: Deferred for clarification for performing pharmaceutical equivalence studies
against Rocephin Injection 2g since this product is not registered in Pakistan.
237. Name, address of Applicant / M/s Biogen Pharmaceuticals 8Km, Chakbeli
☐ Importer
giver)
2020.
☐ Export sale
The proposed proprietary name / brand GEN-ONE 250mg Capsule
name
Pharmaceutical ingredient (API) per unit Cephradine as monohydrate………250mg
Pharmaceutical form of applied drug White to yellowish powder filled in purple/purple
hard gelatin capsule
specifications
The status in reference regulatory Cephradine capsule (MHRA Approved)
authorities
For generic drugs (me-too status) Velosef capsule by GSK

product.
months.
stability.
product against Velosef capsule.
product against Velosef capsule. Firm has tested
CDP in three dissolution medium and the results
of f2 factor are within the acceptable limit.
Lahore.
API Lot No. 00204/164/2020
Description of Pack
Alu-alu blister

Batch No. T-046 T-047 T-048
Batch Size 1000 capsule 1000 capsule 1000 capsule
No. of Batches 03
firm (if any)
Cephradine (compacted).
testing
accelerated)
Evaluation by PEC:

1. The method of analysis of the drug Firm has submitted method of analysis of
substance of Pharmagen Limited the drug substance of Pharmagen Limited
submitted in section 3.2.S.4.2 is different submitted in section 3.2.S.4.2 as per USP
from BP as well as USP monograph. monograph.
2. Submit specifications as well as analytical Firm has submitted specifications as well as
method of the drug substance from the analytical method of the drug substance
drug product manufacturer in section from the drug product manufacturer in
3.2.S.4.1 and 3.2.S.4.2. section 3.2.S.4.1 and 3.2.S.4.2.
3. Submit data in section 3.2.S.4.3 as per the Firm has submitted verification studies of
guidance document approved by analytical method of drug substance in
Registration Board section 3.2.S.4.3.

4. Submit COA of relevant batch of drug Firm has submitted COA of relevant batch
substance used in product development of drug substance used in product
and stability studies from both drug development and stability studies from both
substance as well as drug product drug substance as well as drug product
manufacturer in section 3.2.S.4.4. manufacturer in section 3.2.S.4.4.
5. Justify how the batch No 0023/163/2019 Firm has submitted COA of the batch
was tested by Biogen Pharma and declared number 00204/164/2020 which was actually
pass without testing the cephalexin used for the manufacturing of three batches.
contents. Further justify how the assay The newly submitted COA contains
limit used by drug product manufacturer is cephalexin contents test.
different from BP as well as of drug
6. Justify the submission of reference Firm has submitted copy of COA of
standard or material in section 3.2.S.5 in working standard from API manufacturer
which USP reference standard is used based on USP standard.
against a drug substance which complies
BP specifications.
7. Submit COA of cephalexin reference Firm has submitted COA of cephalexin
standard which is also required in the reference standard.
analysis of drug substance.
8. Justify the selection of excipients in the Firm has submitted that the formulation was
master formulation, since your qualitative as per the reference product.
composition is different from that of
reference product.
9. Justify why drug-excipient compatibility Firm has submitted that the formulation was
studies is not performed while the as per the reference product.
formulation is qualitatively different from
that of reference product.
10. Specify the details regarding Batch Velosef 250mg Capsule by GSK (Batch
number, manufacturing date and expiry number UD2P)
date of the product against which
pharmaceutical equivalence and CDP is
not performed.
11. Submit evidence of procurement of drug Firm has submitted copy of commercial
substance from Pharmagen Limited. invoice dated 07-04-2020 specifying
purchase of 5Kg Cephradine (compacted).
Decision: Approved.
• Firm shall submit fee for change of title of the firm from Biogen Pharmaceuticals to
Biogen Life Sciences.
238. Name, address of Applicant / M/s Biogen Pharmaceuticals 8Km, Chakbeli
☐ Importer
giver)

2020.
☐ Export sale
The proposed proprietary name / brand GEN-ONE 500mg Capsule
name
Pharmaceutical ingredient (API) per unit Cephradine as monohydrate………500mg
Pharmaceutical form of applied drug White to yellowish powder filled in purple/purple
hard gelatin capsule
specifications
The status in reference regulatory Cephradine capsule (MHRA Approved)
authorities
For generic drugs (me-too status) Velosef capsule by GSK
product.

months.
stability.
product against Velosef capsule.
product against Velosef capsule. Firm has tested
CDP in three dissolution medium and the results
of f2 factor are within the acceptable limit.
Lahore.
API Lot No. 00204/164/2020
Description of Pack
Alu-alu blister
Batch No. T-049 T-050 T-051
Batch Size 1000 capsule 1000 capsule 1000 capsule
No. of Batches 03

firm (if any)
Cefixime (compacted).
testing
accelerated)
Evaluation by PEC:

1. The method of analysis of the drug Firm has submitted method of analysis of
substance of Pharmagen Limited the drug substance of Pharmagen Limited
submitted in section 3.2.S.4.2 is different submitted in section 3.2.S.4.2 as per USP
from BP as well as USP monograph. monograph.
2. Submit specifications as well as analytical Firm has submitted specifications as well as
method of the drug substance from the analytical method of the drug substance
drug product manufacturer in section from the drug product manufacturer in
3.2.S.4.1 and 3.2.S.4.2. section 3.2.S.4.1 and 3.2.S.4.2.
3. Submit data in section 3.2.S.4.3 as per the Firm has submitted verification studies of
guidance document approved by analytical method of drug substance in
Registration Board section 3.2.S.4.3.
4. Submit COA of relevant batch of drug Firm has submitted COA of relevant batch
substance used in product development of drug substance used in product
and stability studies from both drug development and stability studies from both
substance as well as drug product drug substance as well as drug product
manufacturer in section 3.2.S.4.4. manufacturer in section 3.2.S.4.4.
5. Justify how the batch No 0023/163/2019 Firm has submitted COA of the batch
was tested by Biogen Pharma and declared number 00204/164/2020 which was actually
pass without testing the cephalexin used for the manufacturing of three batches.
contents. Further justify how the assay The newly submitted COA contains
limit used by drug product manufacturer is cephalexin contents test.
different from BP as well as of drug
6. Justify the submission of reference Firm has submitted copy of COA of
standard or material in section 3.2.S.5 in working standard from API manufacturer
which USP reference standard is used based on USP standard.
against a drug substance which complies
BP specifications.

7. Submit COA of cephalexin reference Firm has submitted COA of cephalexin
standard which is also required in the reference standard.
analysis of drug substance.
8. Justify the selection of excipients in the Firm has submitted that the formulation was
master formulation, since your qualitative as per the reference product.
composition is different from that of
reference product.
9. Justify why drug-excipient compatibility Firm has submitted that the formulation was
studies is not performed while the as per the reference product.
formulation is qualitatively different from
that of reference product.
10. Specify the details regarding Batch Velosef 500mg Capsule by GSK (Batch
number, manufacturing date and expiry number UC2P)
date of the product against which
pharmaceutical equivalence and CDP is
not performed.
11. Submit evidence of procurement of drug Firm has submitted copy of commercial
substance from Pharmagen Limited. invoice dated 07-04-2020 specifying
purchase of 5Kg Cephradine (compacted).
Decision: Approved.
• Firm shall submit fee for change of title of the firm from Biogen Pharmaceuticals to
Biogen Life Sciences.
b) Deferred cases
239. Name, address of Applicant / M/s Benson Pharmaceuticals Plot # 3 Main

Marketing Authorization Holder Road National Industrial Zone RCCI Rawat
Rawalpindi.
Name, address of Manufacturing site. M/s Bio-Next Pharmaceuticals Plot No. 50, St
No. S-10, RCCI Industrial Estate Rawat
Islamabad.
☐ Importer
giver)
Contract manufacturing agreement dated 12-12-
2020 is submitted

☐ Export sale
The proposed proprietary name / brand MEROBEN 500 mg Injection IV
name
Pharmaceutical form of applied drug Glass vial filled with almost white powder along
with 10ml ampoule of WFI further packed in unit
carton.
specifications
authorities
Name and address of API manufacturer. Rajasthan Antibiotics Ltd. Plot No. 619 & 630
RIICO Industrial Area Bhiwadi – District Alwar
Rajasthan India.
product.

months.
stability.
500mg injection.
of product analytical method for the drug substance and drug
product.
Manufacturer of API Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial Area
Bhiwadi – District Alwar Rajasthan India.
API Lot No. UIMRPS19021
Description of Pack
Glass vial
Batch No. MR-001 MR-002 MR-003
No. of Batches 03
1. Reference of previous approval of Not applicable.
firm (if any)
API manufacturer issued by concerned DC/A-1/WHO-GMP/2020/1961) issued by Drugs
regulatory authority of country of origin. control organization, Governmnet of Rajasthan
dated 09-12-2020. The certificate is valid till 26-
02-2022.

3. Documents for the procurement of API with • Firm has submitted copy of Form 6 “License to
approval from DRAP (in case of import). import drugs for clinical trial, examination, test
or analysis” for import of meropenem 3Kg from
M/s Rajasthan Antibiotics Ltd. Plot No. 619 &
630 RIICO Industrial Area Bhiwadi – District
Alwar Rajasthan India issued by AD (I&E)
DRAP field office. The license was issued on
02-01-2020.
• Firm has submitted copy of commercial invoice
dated 02-01-2020 specifying import of 3Kg
meropenem. The invoice is signed by AD (I&E)
DRAP.
21CFR & audit trail reports on product testing of HPLC for only single day 01-07-2020.
testing
accelerated)
Evaluation by PEC:
Firm has initially submitted stability study data of trial batches for the contract manufacturing. As
per the decision of 312nd meeting of Registration Board the firm was asked to submit product
development and stability study data of commercial batches manufactured by M/s Bio-Next
Pharmaceuticals.
Firm has submitted tability study data of commercial batches but the batches were manufactured
using drug substance from Shenzhen Haibin Pharmaceuticals. Firm has submitted following
documents:
• Audit trail report
• Process validation report dated 21-05-2021.
• Stability study data of the following batches
21E001 21E002 21E005
14598 vials 14598 vials 14598 vials
05-2021 05-2021 05-2021
07-05-2021 08-05-2021 21-05-2021
However, the firm has not provided complete data of new drug substance and drug product required
as per the CTD guidance document.
Decision of 316th meeting of Registration Board:

Deferred for following:
• Submission of complete data of drug substance as well as drug product in module-2 and
module-3 as per the Form 5-F guidance document (PE&R/GL/AF/004) approved by the
Registration Board.
• Submission of fee of Rs. 75,000 for revision in stability data as well as change of source of
drug substance, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Fresh Submission by the firm

Name and address of API manufacturer. Shenzhen Haibin Pharmaceutical Co., Ltd. No. 2003,
Shenyan Road, Yantian District, Shenzhen City,
Guangdong Province, P.R China
drug product.
substance.
(Conditions & duration of Stability studies) of drug substance at both accelerated as well as real
time conditions. The accelerated stability data is
conducted at 40oC ± 2oC / 75% ± 5% RH for 6
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical
Dissolution Profile equivalence for all the quality tests for their product
against the comparator i.e. Meronem 500mg
injection of Pfizer Limited.
Analytical method validation/verification of Firm has submitted report of verification of analytical
product method for the drug substance and drug product.
Manufacturer of API Shenzhen Haibin Pharmaceutical Co., Ltd. No. 2003, Shenyan Road,
Yantian District, Shenzhen City, Guangdong Province, P.R China.

Batch No. 21E001 21E002 21E005
No. of Batches 03
firm (if any)
API manufacturer issued by concerned GD20190927) issued by China Food and Drug
regulatory authority of country of origin. Administration dated 04-01-2019. The certificate
is valid till 03-01-2024.
160Kg meropenem. The invoice is signed by AD
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
substance manufactured by M/s Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial Area
Bhiwadi – District Alwar Rajasthan India. Later the firm submitted 6 months stability study data of
three commercial batches along with complete module 2 and module 3. Firm has submitted fee
75,000/- (Slip number 506116296955) dated 09-06-2022 for change of drug substance manufacturer
and of change of stability study batches.
Decision: Approved.
• The Board decided that the registration letter will be issued after revision of drug
product specification as per USP including test for sodium content along with
submission of applicable fee that is 75,000/- for revision of specifications and change of
source of drug substance as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.

• The Board Authorized its Chairman for issuance of registration letter upon capacity
assessment of manufacturing and testing facility Capacity assessment of M/s Bio-Next
240. Name, address of Applicant / M/s Benson Pharmaceuticals Plot # 3 Main
Marketing Authorization Holder Road National Industrial Zone RCCI Rawat
Rawalpindi.
Islamabad.
☐ Importer
giver)
2020 is submitted
☐ Export sale
The proposed proprietary name / brand MEROBEN 1g Injection IV
name
carton.
specifications
authorities
Rajasthan India.

product.
months.
stability.
product against the comparator i.e. Meronem 1g
injection.
product.
Description of Pack
Glass vial

No. of Batches 03
firm (if any)
regulatory authority of country of origin. control organization Governmnet of Rajasthan
02-2022.
02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.

documents:
21E008 21E009 21E010
05-2021 05-2021 05-2021
24-05-2021 25-05-2021 26-05-2021

Registration Board.
Fresh submission by the firm:
drug product.
substance.

against the comparator i.e. Meronem 1g injection of
Pfizer Limited.
Batch No. 21E008 21E009 21E010
No. of Batches 03
firm (if any)
(I&E) DRAP.

testing
accelerated)
Evaluation by PEC:
Decision: Approved.
2021.
241. Name, address of Applicant / M/s Cherwel Pharmaceuticals (Pvt) Ltd. Plot #
Marketing Authorization Holder 20, Phase 4, Hattar Industrial Estate Hattar.
Islamabad.
☐ Importer
giver)
2017 is submitted
☐ Export sale

The proposed proprietary name / brand MEROFACT 500 mg Injection IV
name
carton.
specifications
authorities
Rajasthan India.
product.
months.

stability.
500mg injection.
product.
Description of Pack
Glass vial
No. of Batches 03
firm (if any)
02-2022.

02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E001 21E002 21E005
05-2021 05-2021 05-2021
07-05-2021 08-05-2021 21-05-2021

Registration Board.

drug product.
substance.

Batch No. 21E001 21E002 21E005
No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
Decision: Approved.
2021.

242. Name, address of Applicant / M/s Cherwel Pharmaceuticals (Pvt) Ltd. Plot #
Marketing Authorization Holder 20, Phase 4, Hattar Industrial Estate Hattar.
Islamabad.
☐ Importer
giver)
2017 is submitted
☐ Export sale
The proposed proprietary name / brand MEROFACT 1g Injection IV
name
carton.
specifications
authorities
Rajasthan India.

product.
months.
stability.
injection.
product.
Description of Pack
Glass vial

No. of Batches 03
firm (if any)
02-2022.
02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:

21E008 21E009 21E010
05-2021 05-2021 05-2021
24-05-2021 25-05-2021 26-05-2021
Registration Board.
drug product.
substance.

Pfizer Limited.
Batch No. 21E008 21E009 21E010
No. of Batches 03
firm (if any)
(I&E) DRAP.
testing

accelerated)
Evaluation by PEC:
Decision: Approved.
2021.
243. Name, address of Applicant / M/s Jupiter Pharma, Plot # 25, S6, National
Marketing Authorization Holder Industrial Zone, Rawat, Islamabad.
Islamabad.
☐ Importer
giver)
2021 is submitted
☐ Export sale
The proposed proprietary name / brand JUPENEM 500 mg Injection IV
name

carton.
specifications
authorities
Rajasthan India.
product.
months.

stability.
500mg injection.
product.
Description of Pack
Glass vial
No. of Batches 03
firm (if any)
02-2022.
02-01-2020.

DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E001 21E002 21E005
05-2021 05-2021 05-2021
07-05-2021 08-05-2021 21-05-2021

Registration Board.

drug product.
substance.
Batch No. 21E001 21E002 21E005

No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
three commercial batches along with complete module 2 and module 3.
• Firm has not submitted fee for change of drug substance manufacturer and of change
of stability study batches.
Decision: Approved.
2021.
244. Name, address of Applicant / M/s Jupiter Pharma, Plot # 25, S6, National
Marketing Authorization Holder Industrial Zone, Rawat, Islamabad..

Islamabad.
☐ Importer
giver)
2021 is submitted
☐ Export sale
The proposed proprietary name / brand JUPENEM 1g Injection IV
name
carton.
specifications
authorities
Rajasthan India.

product.
months.
stability.
injection.
product.
Description of Pack
Glass vial

No. of Batches 03
firm (if any)
02-2022.
02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E008 21E009 21E010

05-2021 05-2021 05-2021
24-05-2021 25-05-2021 26-05-2021
Registration Board.
drug product.
substance.

Pfizer Limited.
Batch No. 21E008 21E009 21E010
No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:

• Firm has not submitted differential fee and fee for change of drug substance
manufacturer and of change of stability study batches.
Decision: Approved.
2021.
Marketing Authorization Holder 112 A, Hayatabad Industrial Estate, Peshawar
Islamabad.
☐ Importer
giver)
2021 is submitted
☐ Export sale
The proposed proprietary name / brand ALLONEM 500 mg Injection IV
name

carton.
specifications
authorities
Rajasthan India.
product.
months.

stability.
500mg injection.
product.
Description of Pack
Glass vial
No. of Batches 03
firm (if any)
02-2022.
02-01-2020.
DRAP.

testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E001 21E002 21E005
05-2021 05-2021 05-2021
07-05-2021 08-05-2021 21-05-2021

Registration Board.

drug product.
substance.
Batch No. 21E001 21E002 21E005

No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
75,000/- (slip number 4621495656) dated 20-07-2022 for change of drug substance manufacturer and
of change of stability study batches.
Decision: Approved.
2021.
Marketing Authorization Holder 112 A, Hayatabad Industrial Estate, Peshawar
Islamabad.
☐ Importer

giver)
2021 is submitted
☐ Export sale
The proposed proprietary name / brand ALLONEM 1g Injection IV
name
carton.
specifications
authorities
Rajasthan India.
product.

months.
stability.
injection.
product.
Description of Pack
Glass vial
No. of Batches 03

firm (if any)
02-2022.
02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E008 21E009 21E010
05-2021 05-2021 05-2021
24-05-2021 25-05-2021 26-05-2021

Registration Board.
drug product.
substance.
Pfizer Limited.

Batch No. 21E008 21E009 21E010
No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
75,000/- (slip number 774298015996) dated 20-07-2022 for change of drug substance manufacturer

Decision: Approved.
2021.
247. Name, address of Applicant / M/s Focus & Rulz Pharmaceuticals Pvt Ltd.
Marketing Authorization Holder 44-Industrial Triangle Kahuta Road,
Islamabad
Islamabad.
☐ Importer
giver)
2020 is submitted
☐ Export sale
The proposed proprietary name / brand MEROVITE 500 mg Injection IV
name
carton.
specifications

authorities
Rajasthan India.
product.
months.
stability.
500mg injection.
product.

Description of Pack
Glass vial
No. of Batches 03
firm (if any)
02-2022.
02-01-2020.
DRAP.
testing
time and accelerated stability chambers.

accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E001 21E002 21E005
05-2021 05-2021 05-2021
07-05-2021 08-05-2021 21-05-2021

Registration Board.
drug product.

substance.
Batch No. 21E001 21E002 21E005
No. of Batches 03
firm (if any)

(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
• Firm has not submitted fee for change of drug substance manufacturer and of change
of stability study batches.
Decision: Approved.
2021.
248. Name, address of Applicant / M/s Focus & Rulz Pharmaceuticals Pvt Ltd.
Marketing Authorization Holder 44-Industrial Triangle Kahuta Road,
Islamabad
Islamabad.
☐ Importer
giver)
2020 is submitted

☐ Export sale
The proposed proprietary name / brand MEROVITE 1g Injection IV
name
carton.
specifications
authorities
Rajasthan India.
product.

months.
stability.
injection.
product.
Description of Pack
Glass vial
No. of Batches 03
firm (if any)

02-2022.
02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E008 21E009 21E010
05-2021 05-2021 05-2021
24-05-2021 25-05-2021 26-05-2021
this application was received in R&I section of DRAP on 25th June 2021.

• Submission of differential fee Rs. 25,000/- for the registration of applied product, since the
notification for revision of fee vide SRO No. F.7-11/2012-B&A/DRA was published on 7th
May 2021 while this application was received in R&I section of DRAP on 25th June 2021.
Registration Board.
drug product.
substance.
Pfizer Limited.

Batch No. 21E008 21E009 21E010
No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:

Decision: Approved.
2021.
249. Name, address of Applicant / M/s Variant Pharmaceuticals Pvt Ltd.
Marketing Authorization Holder Plot No. 5, M2-Pharma Zone Lahore,
Sharikpur Road, Sheikhupura
Islamabad.
☐ Importer
giver)
dated 10-11-2020.
☐ Export sale
The proposed proprietary name / brand VARINUM 500mg IV Injection
name
carton.

specifications
authorities
Rajasthan India.
product.
months.
stability.

500mg injection.
product.
Description of Pack
Glass vial
No. of Batches 03
firm (if any)
02-2022.
02-01-2020.
DRAP.

testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:
21E001 21E002 21E005
05-2021 05-2021 05-2021
07-05-2021 08-05-2021 21-05-2021

Registration Board.

drug product.
substance.
Batch No. 21E001 21E002 21E005

No. of Batches 03
firm (if any)
(I&E) DRAP.
testing
accelerated)
Evaluation by PEC:
Decision: Approved.
2021.
250. Name, address of Applicant / M/s Variant Pharmaceuticals Pvt Ltd.
Marketing Authorization Holder Plot No. 5, M2-Pharma Zone Lahore,
Sharikpur Road, Sheikhupura
Islamabad.

☐ Importer
giver)
dated 10-11-2020.
☐ Export sale
The proposed proprietary name / brand VARINUM 1g IV Injection
name
carton.
specifications
authorities
Rajasthan India.

product.
months.
stability.
injection.
product.
Description of Pack
Glass vial

No. of Batches 03
firm (if any)
02-2022.
02-01-2020.
DRAP.
testing
accelerated)
Evaluation by PEC:
Pharmaceuticals.
documents:

21E008 21E009 21E010
05-2021 05-2021 05-2021
24-05-2021 25-05-2021 26-05-2021
Registration Board.
drug product.
substance.

Pfizer Limited.
Batch No. 21E008 21E009 21E010
No. of Batches 03
firm (if any)
(I&E) DRAP.
testing

accelerated)
Evaluation by PEC:
Decision: Approved.
2021.
251. Name, address of Applicant / M/s Swiss Pharmaceuticals (Pvt) Ltd. A/159, SITE,
Marketing Authorization Holder Super Highway Karachi.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot No. 204-
205, Industrial Triangle Kahuta Road Islamabad.
☐ Importer
GMP status of the firm Swiss Pharmaceuticals: 18-10-2018: GMP
compliance level is rated as GOOD.”
Global pharmaceuticals: Firm has submitted copy of
GMP certificate dated 04-01-2022 issued on the basis
of inspection dated 03-01-2022.
Evidence of approval of Firm has submitted copy of letter of Grant of additional
manufacturing facility section / amendment under DML No 000417 of M/s
Global Pharmaceuticals Islamabad dated 18-12-2017
specifying reallocation of dry powder injection
(carbapenem) section is place of withdrawn Biotech
section (BSF)
product

☐ Export sale
Proposed proprietary name/brand MEPEN 500mg Injection
name
Active Pharmaceutical ingredient Meropenem trihydrate eq to meropenem……500mg
(API) per unit
Pharmaceutical form of applied drug White to off white powder filled in clear glass vials with
sea green color flip off seal along with 10ml WFI
ampoule.
specifications
authorities
Name and address of API M/s Sterile India Pvt Ltd. Plot No. 100& 118-G, Phase-
manufacturer. IV, Sector-56, HSIIDC, Industrial Estate Kundli
District Sonepat Haryana India.
time stability data is conducted at 30°C ± 2°C / 65 ± 5%
RH for 36 months.

against Merrem 500mg Injection of Pfizer.
Manufacturer of API M/s Sterile India Pvt Ltd. Plot No. 100& 118-G, Phase-IV, Sector-56,
HSIIDC, Industrial Estate Kundli District Sonepat Haryana India.
S1/BMPM/1031017
Description of Pack
system)
Batch No. 17L078 17L079 17M319
No. of Batches 03
applications with stability study data data of the same dosage form on the basis of which
of the firm (if any) Registration Board in 289th meeting decided to approve
registration of Promig Plus 500mg/20mg Tablet and
Promig Plus 375mg/20mg Tablet.
• The firm has provided data loggers with stability
chambers.
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (No. 12/80-
certificate of API manufacturer issued 2Drug1-2019/3739 issued by Food and Drugs
by concerned regulatory authority of Administration Haryana dated 21-05-2019. The
country of origin. certificate is valid till 2 years from the date of issue.
3. Documents for the procurement of Firm has submitted copy of commercial invoice cleared
API with approval from DRAP (in dated 23-10-2017 specifying import of 20Kg (4x5Kg)
case of import). Meropenem for injection for Batch No.
S1/BMPM/0990917. The commercial invoice is
attested by AD (I&E) DRAP field office. Firm has

submitted copy of commercial invoice cleared dated 03-
11-2017 specifying import of 20Kg (4x5Kg)
Meropenem for injection for Batch No.
S1/BMPM/1031017. The commercial invoice is
attested by AD (I&E) DRAP field office.
documents like chromatograms, Raw COA and summary data sheets.
sheets etc.
testing
temperature and humidity monitoring temperature and humidity monitoring of real time and
of stability chambers (real time and accelerated stability chambers.
accelerated)
Evaluation by PEC:
Shortcomings communicated Response by the firm
Provide name and address of the applicant i.e. M/s Firm has revised the address of applicant on
Swiss Pharmaceuticals (Pvt) Ltd as per the address Form 5F without submission of any fee.
mentioned on Drug Manufacturing License (DML)
along with submission of requisite fee (if
applicable), since the address mentioned on section
1.3.1 is different from that mentioned in the DML.
Provide correct label claim as per the innovator / Firm has submitted revised label claim as per
reference product in section 1.5.2 along with the reference product without submission of
submission of requisite fee, since the submitted fee.
label claim is incomplete and it does not specify the
sodium carbonate component.
Provide copies of IR spectra of the drug substance Firm has submitted copies of IR spectra of
in section 3.2.S.3.1 as per the guidance document drug substance from the API manufacturer.
approved by Registration Board which specifies
that “Drug substance /Active Pharmaceutical
Ingredients that are described in an officially
recognized pharmacopoeia it is generally sufficient
to provide copies of the IR spectrum.
Submit data in section 3.2.S.4.1 as per the guidance Firm has submitted drug substance
document approved by Registration Board which manufacturer’s specification and testing
specifies that “Copies of the Drug substance method separately for meropenem trihydrate,
specifications and analytical procedures used for sodium carbonate and meropenem for
routine testing of the Drug substance /Active injection without specifying the exact
Pharmaceutical Ingredient by both Drug substance specifications of their drug substance.
& Drug Product manufacturer is required.” Further specifications and method of
analysis from drug product manufacturer is
not submitted.
Justify why the test of content of sodium is not Firm has revised the specifications and added
included in the specifications of drug substance. test of sodium. The specifications have been
revised without submission of fee.
Justify the acceptance criteria of assay “NLT 78% Meropenem for injection is a combination of
as meropenem on dried basis”, since this is not in meropenem with sodium carbonate so after
line with the USP monograph. subtraction of sodium carbonate and water
contents the limit is NLT 78%.

Justify the flow rate of 1.0ml/min for the assay test Firm has revised the specifications and
of drug substance, since USP recommends flow changed the flow rate to 1.5ml/min. The
rate to be 1.5ml/min. specifications have been revised without
submission of fee.
Provide complete method of standard and sample Firm has submitted revised specification and
preparation in assay test of drug substance. Just testing method.
mentioning the final concentration without As per revised testing method the sample
specifying the initial quantity of material taken and preparation method is totally different from
the dilution steps is not permitted by any that specified in USP monograph.
guidelines.
As per the assay method of drug substance, the Firm has submitted revised specification and
sample solution is nominally 0.1mg/ml of testing method.
meropenem in mobile phase. While as per USP As per revised testing method the sample
monograph the sample solution preparation method preparation method is totally different from
is entirely different which involves initial that specified in USP monograph. Firm took
reconstitution with water prior to dilution with meropenem sample equivalent to 50mg in
mobile phase. Justify how the tests performed by 50ml volumetric flask and make up the
your method can be considered acceptable under volume with mobile phase.
the USP monograph.
The USP monograph under the assay method Firm has now mentioned this statement in
specifies that sample should be hold for 1-2 hours their testing method.
at 25± 1°C before testing, while your method does
not mention the same. Justify how your method
could be considered as complying with USP
monograph.
Justify the submission of batch analysis of 3 Method verification for the product is
batches of drug substance instead of providing the performed and we use same testing method
report of validation studies of the analytical method for the drug substance. Since it is ready to fill
in section 3.2.S.4.3. Further justify how the drug powder so for this reason we did not perform
substance testing was carried out without method validation of API.
performing verification studies of the analytical
method of drug substance as recommended by USP
monograph.
Justify why the test of sodium carbonate content Initially in 2017 we do not hve atomic
and sodium content is not performed for the batch absorption so we consider this value from
of drug substance S1/BMPM/0990917 (testing manufacturer COA, now we purchased
performed on 31-10-2017) and batch number atomic absorption which is used for the
S1/BMPM/1031017 (testing performed on 16-11- determination of sodium content.
2017).
Justify how the results of assay of drug substance Firm has submitted that testing method has
on dried basis is obtained, since this method been revised and all required formulas are
(formula) is not mentioned in your analytical incorporated.
method nor specified in USP.
USP specifies tailing factor NMT 1.5 in the system Testing method is revised as per current USP
suitability requirements, while the tailing factor and revised testing method followed now and
values obtained in your chromatograms of drug tailing factor value reviewed during the
substance show results greater than 1.5. Justify how checking of testing results and testing report.
the test was performed without complying the Firm has not justified the previous analysis
system suitability requirements as per USP in which tailing factor was above 1.5.
monograph.
The standard solution and the sample solution We run standard solution and sample
analysis for drug substance testing was performed solution both, whenever we perform the
using different HPLC equipment and software. testing of any API or finished product on
Justify how the analysis could be considered same HPLC, which makes the achieved
results reliable and we check the system

reliable if the standard solution are run in different suitability parameters in all routine testing to
equipment. comply the requirement.
Firm has not provided any scientific
justification.
Justify the HPLC testing of sample solution using Testing method is revised as per current USP
detector 220nm while the USP recommends that and revised testing method provided. Firm
testing be performed at 300nm. has not provided any justification for testing
of stability batches for which testing was
conducted at 200nm. All these batches are
now expired as well.
As per the raw data sheets, the value of potency of The potency is based on as is basis which is
meropenem in meropenem reference standard is used for the testing of drug substance.
73.91%. Justify how this reference standard was
used in the testing of drug substance which is very
low purity and contents.
Provide COA of reference standard / working Firm has submitted certificate of USP
standard used in the testing of drug substance. reference standard. However, the testing
method of the firm specifies that meropenem
working standard is used.
Justify how 707mg of meropenem as trihydrate The calculation provided by the firm does
blended with sodium carbonate contains 500mg of not incorporate the sodium carbonate
meropenem. contents.
Provide details including batch number, expiry date Not submitted
and name of manufacturer of the innovator product
along with pharmaceutical equivalence was
performed.
Justify why complete tests as mentioned in USP are Not submitted
not performed in pharmaceutical equivalence.
Provide data in section 3.2.P.2.6 as per the Not submitted
guidance document approved by Registration
Board which specifies that “Compatibility studies
for the dry powder for injections and dry powder
for suspension shall be performed as per the
instructions provided in individual label of the drug
product.”
Justify why the test of content of sodium and loss Testing method revised as per current USP
on drying is not mentioned in the specifications of and revised testing method provided and
the drug product provided in section 3.2.P.5.1. implemented for onward testing.
Justify the sample solution preparation method Testing method revised as per current USP
under the assay test of drug product is different and revised testing method provided and
from that mentioned in USP monograph. implemented for onward testing.
Justify why the calculation formula of assay Testing method revised as per current USP
content of drug product is different from that and revised testing method provided and
specified in USP monograph. implemented for onward testing.
Justify the submission of COA of commercial Firm has submitted certificate of USP
batch (S1/BMPM/0990917 and reference standard.
S1/BMPM/1031017) in section 3.2.P.6 as the However, the testing method of the firm
reference standard. specifies that meropenem working standard
is used.
Justify how meropenem (trihydrate) for injection is We used meropenem (trihydrate) as working
used as reference standard since the USP standard after standardizing it against USP
recommends that meropenem (base) should be used reference standard.
as reference standard for assay test of meropenem
for injection.

Submit data in section 3.2.P.8 as per the guidance Firm has only provided a statement of shelf
document approved by Registration Board which life after reconstitution. No data has been
specifies that “Summary of additional stability submitted.
studies (if applicable) e.g. in-use studies for drug
products which are to be reconstituted before use, The reference product specify the shelf life
along with proposed in-use storage statement and after reconstitution as 3 hours at room
in-use shelf-life shall be provided”. temperature while the firm has claimed 12
hours even without any data.
Justify why the test of content of sodium, Testing parameters are not completely
completeness and clarity of solution, loss on drying followed in stability studies only assay and
and sterility test is not included in the stability pH test is performed.
studies of the product.
The results of assay test of meropenem for the batch This increase in assay may be due to the API
No. 17L078 show upward trend (i.e. increase in assay content vial used for assay testing has filled
values with time) throughout the stability studies weight of higher limit.
(both accelerated and real time). Provide scientific
justification for this upward trend keeping in view the Firm has not provided any scientific
fact that the testing method was not exactly as per justification
USP monograph, the reference standard meropenem
(trihydrate) for injection was used instead of
meropenem (base), the contents of sodium, as well as
sodium carbonate was not determined at any time
point during stability studies and loss on drying is
also not performed during the stability studies.
You have imported 20Kg meropenem for injection Firm submitted that they have imported 20
in the packing of 5Kg aluminium container. Justify Kg (5kg container x 4) while in each batch
how the batches of 5.4Kg were developed using the 5.4 Kg was used.
same container. Firm has not submitted any justification from
where that extra 0.4Kg was added in each
batch.
Provide Batch Manufacturing Record (BMR) for Firm has submitted copy of BMR of the three
all the three stability batches. stability batches.
Registration Board delibrated the case in detail and observed that the contract manufacturer has not
performed complete product development studies, the specifications adopted by the manufacturer
throughout stability studies were not according to USP and that the stability batches have also
expired. Accordingly, the Board deferred for following submissions:
• Drug substance specifications and analytical procedures used for routine testing of the Drug
substance by both Drug Product manufacturer.
• Scientific justification for using flow rate of 1.0ml/min for assay testing of your commercial
batches since USP recommends flow rate to be 1.5ml/min,
• Scientific justification for having analytical method of drug product without specifying that
“sample should be hold for 1-2 hours at 25± 1°C before testing” which is recommended in
USP monograph.
• Scientific justification for releasing the commercial batch of drug product and during its
stability studies even after having the value of tailing factor above 1.5, since USP monograph
specifies tailing factor NMT 1.5 in the system suitability requirements.
• Scientific justification for using different HPLC equipment and software for the standard
solution and the sample solution analysis.
• Scientific justification for HPLC testing of your commercial batches using UV detector at
220nm while the USP recommends that testing be performed at 300nm.

• Scientific justification for using reference / working standard having a potency of 73.91% for
the analysis of commercial batches.
• Scientific justification for having a master formulation containing 707mg of meropenem
trihydrate blended with sodium carbonate which is equivalent to 500mg meropenem.
• Provision of details including batch number, expiry date and name of manufacturer of the
innovator product along with pharmaceutical equivalence was performed.
• Scientific justification for not performing compatability studies of the drug product with the
recommended diluent.
• Scientific justification for not performing the test of sodium content and loss on drying for
the analysis of commercial batches of the drug product.
• Scientific justification for using an entirely different formula for calculation of assay resultsof
commercial batches from that specified in USP monograph.
• Scientific justification for not performing test of content of sodium, completeness and clarity
of solution, loss on drying and sterility test during the stability studies of the product.
• Scientific justification for the results of assay test of meropenem for the batch No. 17L078
which show upward trend (i.e. increase in assay values with time) throughout the stability
studies (both accelerated and real time) keeping in view the fact that the testing method was
not exactly as per USP monograph, the reference standard meropenem (trihydrate) for
injection was used instead of meropenem (base), the contents of sodium, as well as sodium
carbonate was not determined at any time point during stability studies and loss on drying is
• Scientific justification how three batches have been manufactured using 5Kg containers while
each batch required 5.4Kg drug substance.
• Evidence of purchase of atomic absorption spectrophotometer including commercial invoice
and Installation Qualification (IQ) and Operational Qualification (OQ) of atomic absorption.
• Submission of fee for pre-registration changes in the drug product specifcations.
Keeping in view the above, the Board decided that the submitted stability study data is not acceptable
and directed the manufacturer to either perform complete product development and stability studies
or submit the aforementioned data as per USP specifications and submit data accordingly. The Board
further directed the manufacturer to comply USP Specifications for already registered drug products.
Reason for deferment Response by the firm
Drug substance specifications and analytical Specifications and Analytical Procedure of Drug
procedures used for routine testing of the Drug Substance by API manufacturer is provided.
Scientific justification for using flow rate of As mentioned in USP monograph of Meropenem
1.0ml/min for assay testing of your commercial for Injection edition 2018 and 2019, retention
batches since USP recommends flow rate to be time should be between 6 to 8 minutes. We were
1.5ml/min, following same criteria regarding flow rate i.e.
1.5ml but due to typographic error flow rate of
1.0ml was mentioned in test method which has
been corrected now.
Scientific justification for having the method of Sample solution preparation was performed as
sample solution preparation for the commercial USP monograph but step of reconstitution with
batches which is entirely different from that water was not previously part of sample solution
specified in USP monograph. preparation. Said step has been incorporated in
revised test method.
Copy of revised test method is also provided.
Scientific justification for having analytical Due to typographic error these details of hold
method of drug product without specifying that time after sample preparation was missed in
“sample should be hold for 1-2 hours at 25± finished product testing method. Testing method
has been revised as per current USP monograph

1°C before testing” which is recommended in
USP monograph.
Scientific justification for releasing the We have checked all chromatograms of raw
commercial batch of drug product and during material testing as well as stability testing but
its stability studies even after having the value found no peak tailing greater than 1.5.
of tailing factor above 1.5, since USP Particular details regarding tailing factor was not
monograph specifies tailing factor NMT 1.5 in previously mentioned in the testing method,
the system suitability requirements. which is now incorporated in revised testing
method of both drug substance and drug product.
Scientific justification for using different We use to run standard solution and sample
HPLC equipment and software for the standard solution both (whenever we perform the testing
solution and the sample solution analysis. of any API or Finished product) on same HPLC
system, as it makes results more reliable and also
verifies system suitability parameters in all-
routine testing.
We have tested assay and impurities on two
separate systems having different softwares, may
be this was confusion factor while data review.
Scientific justification for HPLC testing of We have followed USP monograph for testing of
your commercial batches using UV detector at assay of drug substance as well as impurities.
220nm while the USP recommends that testing USP monograph specifies 300nm for assay
be performed at 300nm. testing of drug substance while 220nm for
impurities testing in drug substance.
Scientific justification for using reference / The potency is on as is basis of Meropenem for
working standard having a potency of 73.91% injection, which has been standardized against
for the analysis of commercial batches. the primary standard (Meropenem base) and is
used as working standard in routine testing.
Scientific justification for having a master Below is the calculation of fill weight if
formulation containing 707mg of meropenem Meropenem 500mg:
trihydrate blended with sodium carbonate As per attached COA,
which is equivalent to 500mg meropenem. Average water content = 10.5%
Average sodium bicarbonate content = 18.5%
By adding both contents, 10.5 + 18.5 = 29%
By subtracting both contents, 100% - 29% = 71%
For Merem 500mg = 500 x 100 =
704.22mg/vial
71
Provision of details including batch number, Firm has provided details for meropenem 1gm
expiry date and name of manufacturer of the injection
innovator product along with pharmaceutical
equivalence was performed.
Scientific justification why complete tests as All tests that are mentioned in USP could not
mentioned in USP monograph were not perform during pharmaceutical equivalence due
performed in pharmaceutical equivalence to limited quantity of innovator sample.
studies. Therefore, we have included only all major test
while performing pharmaceutical equivalence.
Scientific justification for not performing Compatibility studies of Merem were performed
compatibility studies of the drug product with but it was not made part of dossier during
the recommended diluent. submission. Detailed compatibility studies of
Merem against its innovator i.e. Merrem was
performed with all its recommended diluents.
Study results are also provided.

Scientific justification for not performing the In 2017, we did not have Atomic Absorption
test of sodium content and loss on drying for there test of content of sodium is not part of
the analysis of commercial batches of the drug specifications of product. Moreover we have
product. now revised specification and LOD and content
of sodium has been incorporated in revised
specifications.
Scientific justification for using an entirely Formula of content of drug product is elaborated
different formula for calculation of assay with context to standard and sample preparation
results of commercial batches from that procedure which has now been updated as per
specified in USP monograph. USP format.
Copy of revised test method and USP
monograph is also provided.
Scientific justification for not performing test Testing parameters like sodium contents, loss on
of content of sodium, completeness and clarity drying has not performed because they can be
of solution, loss on drying and sterility test monitored indirectly. The justifications given as
during the stability studies of the product. below:
• Sodium is the part of Sodium carbonate
which in this mixture of meropenem for injection
acts as a buffer and controls the pH of the
mixture. A pH drift will depict the change in
buffer contents, as Sodium being metal does not
degrade in ordinary conditions.
• Loss on drying has a direct impact on the
active ingredient stability/degradation. Assay
determination depicts the impact cause by this
parameter.
• In physical check of stability samples we
use to perform this test after reconstitution with
prescribed amount of water but this test was not
separately mentioned in stability data.
As for as sterility is concerned it was not part of
stability testing. We have revised our stability
protocols and included all critical Quality
attributes in stability testing and implemented for
onward stability testing.
Scientific justification for the results of assay Assay results of initial time point of 17L078
test of meropenem for the batch No. 17L078 batch are significantly low than all remaining
which show upward trend (i.e. increase in assay samples tested during whole stability. This is
values with time) throughout the stability because of low filled weight vial of finished
studies (both accelerated and real time) keeping product tested at zero time point. As far as results
in view the fact that the testing method was not of all other time points are concerned there is a
exactly as per USP monograph, the reference little difference between assays results i.e. hardly
standard meropenem (trihydrate) for injection one to two percent. Therefore, speculation
was used instead of meropenem (base), the regarding deviation from USP monograph is
contents of sodium, as well as sodium completely ruled out as same method has been
carbonate was not determined at any time point applied while testing other stability batches and
during stability studies and loss on drying is no such trend has been seen there.
Scientific justification how three batches have During interpretation of data from BMR while
been manufactured using 5Kg containers while preparation of dossier 5.4kg has been mistakenly
each batch required 5.4Kg drug substance. considered batch size by regulatory person.
Actual batch size as stated in BMR is 5.0kg.
Moreover meropenem as ready to fill powder is
imported in container of 5.0kg.

Evidence of purchase of atomic absorption Field Service Report dated 25-10-2019 is
spectrophotometer including commercial provided from Rays Technologies. In report it is
invoice and Installation Qualification (IQ) and mentioned that IQ, OQ and PQ of the instrument
Operational Qualification (OQ) of atomic is perfomed and the instrument is handed over to
absorption. user in working condition. However no details of
the equipment / instrument is provide.
Submission of fee for pre-registration changes Firm has submitted fee 7500/- dated 05-11-2021
in the drug product specifications. for change in specifications
Keeping in view the above, the Board decided Firm has not submitted product development and
that the submitted stability study data is not stability study data of new batches in which the
acceptable and directed the manufacturer to development and testing is carried out as per
either perform complete product development USP specifications from initial time point.
and stability studies or submit the
aforementioned data as per USP specifications
and submit data accordingly. The Board further
directed the manufacturer to comply USP
Specifications for already registered drug
products.
Decision of 313rd meeting of Registration Board:
Registration Board deliberated that the commercial batches manufactured by the manufacturer i.e.
Global Pharmaceuticals was not developed and tested as per the USP monograph. Keeping in view
the USP monograph, public assessment report of the innovator product and the data submitted by the
firm, the Board decided to defer the case and advised the manufacturer to perform product
development studies keeping in view the innovator product and product testing and stability studies
by complying USP monograph and submit data upon completion of 6 months stability studies.
The firm on 13-01-2022 submitted new response against the decision of 312nd meeting of
Registration Board instead of complying the decision of 313rd meeting of Registration Board.
In the new submission, the firm has changed the source of drug substance from M/s Sterile India Pvt
Ltd. India to M/s Shenzhen Haibin Pharmaceutical Co. Ltd China. Furthermore, the firm has
submitted stability data of following new batches:
Batch No. Batch size Mfg date Stability initiation

date
21A057 7072 Vials 01-2021 23-01-2021
21D216 7072 Vials 04-2021 06-05-2021
21E156 7072 vials 05-2021 01-06-2021
Firm has submitted data which shows that the product testing has been conducted as per revised specs
and calculation formula however firm has revised their specifications after 312nd meeting which was
conducted on 14-16 Septeber 2021 and the revised specifications were considered by the Board in its
313rd meeting held on 16-18 November 2021.
Deferred for submission of complete data of drug substance as well as drug product as per revised
specifications in module-2 and module-3 as per the Form 5-F guidance document
(PE&R/GL/AF/004) approved by the Registration Board.
changed the source of drug substance to CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd.
No. 88, Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei
Province PR. China. Firm has not submitted any fee for change of source as well as submission
of stability study data of new batches.

Firm has also submitted module 2 and module 3 along with stability study data, the details of which
are as under:
Manufacturer of API M/s CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd. No. 88,
Yangzi Road, Shijiazhuang Economic and Technological Development
Zone, Hebei Province PR. China.
API Lot No. 682107003
Description of Pack
Glass vial
Batch No. 22A169 22A363 22A364
No. of Batches 03
1. Reference of previous approval of The firm has referred to previous inspection of
applications with stability study data of the stability data of the same dosage form on the basis
firm (if any) of which Registration Board in 289th meeting
decided to approve registration of Promig Plus
500mg/20mg Tablet and Promig Plus
375mg/20mg Tablet.
stability chambers.
API manufacturer issued by concerned HE20180065) issued by China Food and Drugs
200Kg Meropenem for Batch No. 682107002 and
682107003. The commercial invoice is attested by
AD (I&E) DRAP field office.
21CFR & audit trail reports on product testing of HPLC for all test intervals.
testing

accelerated)
Evaluation by PEC:
Development Zone, Hebei Province PR. China. Firm has not submitted any fee for change
of source as well as submission of stability study data of new batches.
• GMP certificate / insepection report of the contract manufacturer is not available within last
three years.
Decision: Approved.
• Registration Board decided that registration letter will be issued after submission of
applicable fee 75,000/ for change of source as well as submission of stability study data
of new batches as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
assessment of manufacturing and testing facility of M/s Global Pharmaceuticals (Pvt)
Ltd. Plot No. 204-205, Industrial Triangle Kahuta Road Islamabad.
252. Name, address of Applicant / M/s Swiss Pharmaceuticals (Pvt) Ltd. A/159, SITE,
Marketing Authorization Holder Super Highway Karachi.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot No. 204-
205, Industrial Triangle Kahuta Road Islamabad.
☐ Importer
GMP status of the firm Swiss Pharmaceuticals: 18-10-2018: GMP
compliance level is rated as GOOD.”
Global pharmaceuticals: Firm has submitted copy of
GMP certificate dated 04-01-2022 issued on the basis
of inspection dated 03-01-2022.
Evidence of approval of Firm has submitted copy of letter of Grant of additional
manufacturing facility section / amendment under DML No 000417 of M/s
Global Pharmaceuticals Islamabad dated 18-12-2017
specifying reallocation of dry powder injection
(carbapenem) section is place of withdrawn Biotech
section (BSF)
Proposed proprietary name / brand MEPEN 1g Injection
name

Active Pharmaceutical ingredient Meropenem trihydrate eq to meropenem……1g
(API) per unit
Pharmaceutical form of applied drug White to off white powder filled in clear glass vials with
brown color flip off seal along with 20ml WFI
ampoule.
specifications
authorities
Name and address of API M/s Sterile India Pvt Ltd. Plot No. 100& 118-G, Phase-
manufacturer. IV, Sector-56, HSIIDC, Industrial Estate Kundli
District Sonepat Haryana India.
time stability data is conducted at 30°C ± 2°C / 65 ± 5%
RH for 36 months.

against Merrem 500mg Injection of Pfizer.
Manufacturer of API M/s Sterile India Pvt Ltd. Plot No. 100& 118-G, Phase-IV, Sector-56,
HSIIDC, Industrial Estate Kundli District Sonepat Haryana India.
Description of Pack
system)
Batch No. 17K282 17K283 17K238
No. of Batches 03
applications with stability study data data of the same dosage form on the basis of which
of the firm (if any) Registration Board in 289th meeting decided to approve
registration of Promig Plus 500mg/20mg Tablet and
Promig Plus 375mg/20mg Tablet.
• The firm has provided data loggers with stability
chambers.
2. Approval of API/ DML/GMP Firm has submitted copy of GMP certificate (No. 12/80-
certificate of API manufacturer issued 2Drug1-2019/3739 issued by Food and Drugs
by concerned regulatory authority of Administration Haryana dated 21-05-2019. The
3. Documents for the procurement of Firm has submitted copy of commercial invoice cleared
API with approval from DRAP (in dated 25-09-2017 specifying import of 20Kg (4x5Kg)
case of import). Meropenem for injection for Batch No.
S1/MPM/01860817. Commercial invoice is attested by
documents like chromatograms, Raw COA and summary data sheets.
sheets etc.

testing
temperature and humidity monitoring temperature and humidity monitoring of real time and
of stability chambers (real time & accelerated stability chambers.
accelerated)
Evaluation by PEC:
Provide name and address of the applicant i.e. M/s Firm has revised the address of applicant on
Swiss Pharmaceuticals (Pvt) Ltd as per the address Form 5F without submission of any fee.
mentioned on Drug Manufacturing License
(DML) along with submission of requisite fee (if
applicable), since the address mentioned on
section 1.3.1 is different from that mentioned in the
DML.
Provide correct label claim as per the innovator / Firm has submitted revised label claim as per
reference product in section 1.5.2 along with the reference product without submission of
submission of requisite fee, since the submitted fee.
label claim is incomplete and it does not specify
the sodium carbonate component.
Provide copies of IR spectra of the drug substance Firm has submitted copies of IR spectra of
in section 3.2.S.3.1 as per the guidance document drug substance from the API manufacturer.
approved by Registration Board which specifies
that “Drug substance /Active Pharmaceutical
Ingredients that are described in an officially
recognized pharmacopoeia it is generally
sufficient to provide copies of the IR spectrum.
Submit data in section 3.2.S.4.1 as per the Firm has submitted drug substance
guidance document approved by Registration manufacturer’s specification and testing
Board which specifies that “Copies of the Drug method separately for meropenem trihydrate,
substance specifications and analytical procedures sodium carbonate and meropenem for
used for routine testing of the Drug substance injection without specifying the exact
/Active Pharmaceutical Ingredient by both Drug specifications of their drug substance. Further
substance & Drug Product manufacturer is specifications and method of analysis from
required.” drug product manufacturer is not submitted.
Justify why the test of content of sodium is not Firm has revised the specifications and added
included in the specifications of drug substance. test of sodium. The specifications have been
revised without submission of fee.
Justify the acceptance criteria of assay “NLT 78% Meropenem for injection is a combination of
as meropenem on dried basis”, since this is not in meropenem with sodium carbonate so after
line with the USP monograph. substraction of sodium carbonate and water
contents the limit is NLT 78%.
Justify the flow rate of 1.0ml/min for the assay test Firm has revised the specifications and
of drug substance, since USP recommends flow changed the flow rate to 1.5ml/min. The
rate to be 1.5ml/min. specifications have been revised without
submission of fee.
Provide complete method of standard and sample Firm has submitted revised specification and
preparation in assay test of drug substance. Just testing method.
mentioning the final concentration without As per revised testing method the sample
specifying the initial quantity of material taken and preparation method is totally different from
the dilution steps is not permitted by any that specified in USP monograph.
guidelines.

As per the assay method of drug substance, the Firm has submitted revised specification and
sample solution is nominally 0.1mg/ml of testing method.
meropenem in mobile phase. While as per USP As per revised testing method the sample
monograph the sample solution preparation preparation method is totally different from
method is entirely different which involves initial that specified in USP monograph. Firm took
reconstitution with water prior to dilution with meropenem sample equivalent to 50mg in
mobile phase. Justify how the tests performed by 50ml volumetric flask and make up the
your method can be considered acceptable under volume with mobile phase.
the USP monograph.
The USP monograph under the assay method Firm has now mentioned this statement in
specifies that sample should be hold for 1-2 hours their testing method.
at 25± 1°C before testing, while your method does
not mention the same. Justify how your method
could be considered as complying with USP
monograph.
Justify the submission of batch analysis of 3 Method verification for the product is
batches of drug substance instead of providing the performed and we use same testing method
report of validation studies of the analytical for the drug substance. Since it is ready to fill
method in section 3.2.S.4.3. Further justify how powder so for this reason we did not perform
the drug substance testing was carried out without method validation of API.
performing verification studies of the analytical
method of drug substance as recommended by
USP monograph.
Justify how the results of assay of drug substance Firm has submitted that testing method has
on dried basis is obtained, since this method been revised and all required formulas are
(formula) is not mentioned in your analytical incorporated.
method nor specified in USP.
USP specifies tailing factor NMT 1.5 in the system Testing method is revised as per current USP
suitability requirements, while the tailing factor and revised testing method followed now and
values obtained in your chromatograms of drug tailing factor value reviewed during the
substance show results greater than 1.5. Justify checking of testing results and testing report.
how the test was performed without complying the Firm has not justified the previous analysis in
system suitability requirements as per USP which tailing factor was above 1.5
monograph.
The standard solution and the sample solution We run standard solution and sample solution
analysis for drug substance testing was performed both, whenever we perform the testing of any
using different HPLC equipment and software. API or finished product on same HPLC,
Justify how the analysis could be considered which makes the achieved results reliable and
reliable if the standard solution are run in different we check the system suitability parameters in
equipment. all routine testing to comply the requirement.
Firm has not provided any scientific
justification.
Justify the HPLC testing of sample solution using Testing method is revised as per current USP
detector 220nm while the USP recommends that and revised testing method provided.
testing be performed at 300nm. Firm has not provided any justification for the
testing of stability batches for which testing
was conducted at 200nm. All these batches
are now expired as well.
As per the raw data sheets, the value of potency of The potency is based on as is basis which is
meropenem in meropenem reference standard is used for the testing of drug substance.
73.91%. Justify how this reference standard was
used in the testing of drug substance which is very
low purity and contents.
Provide COA of reference standard / working Firm has submitted certificate of USP
standard used in the testing of drug substance. reference standard.

However, the testing method of the firm
specifies that meropenem working standard is
used.
Justify how 1413mg of meropenem as trihydrate The calculation provided by the firm does not
blended with sodium carbonate contains 1g of incorporate the sodium carbonate contents.
meropenem.
Provide details including batch number, expiry Not submitted
date and name of manufacturer of the innovator
product along with pharmaceutical equivalence
was performed.
Justify why complete tests as mentioned in USP Not submitted
are not performed in pharmaceutical equivalence.
Provide data in section 3.2.P.2.6 as per the Not submitted
guidance document approved by Registration
Board which specifies that “Compatibility studies
for the dry powder for injections and dry powder
for suspension shall be performed as per the
instructions provided in individual label of the
drug product.”
Justify why the test of content of sodium and loss Testing method revised as per current USP
on drying is not mentioned in the specifications of and revised testing method provided and
the drug product provided in section 3.2.P.5.1. implemented for onward testing.
Justify the sample solution preparation method Testing method revised as per current USP
under the assay test of drug product is different and revised testing method provided and
from that mentioned in USP monograph. implemented for onward testing.
Justify why the calculation formula of assay Testing method revised as per current USP
content of drug product is different from that and revised testing method provided and
specified in USP monograph. implemented for onward testing.
Justify the submission of COA of commercial Firm has submitted certificate of USP
batch (S1/BMPM/0990917 and reference standard.
S1/BMPM/1031017) in section 3.2.P.6 as the However, the testing method of the firm
reference standard. specifies that meropenem working standard is
used.
Justify how meropenem (trihydrate) for injection We used meropenem (trihydrate) as working
is used as reference standard since the USP standard after standardizing it against USP
recommends that meropenem (base) should be reference standard.
used as reference standard for assay test of
meropenem for injection.
Submit data in section 3.2.P.8 as per the guidance Firm has only provided a statement of shelf
document approved by Registration Board which life after reconstitution. No data has been
specifies that “Summary of additional stability submitted.
studies (if applicable) e.g. in-use studies for drug
products which are to be reconstituted before use, The reference product specify the shelf life
along with proposed in-use storage statement and after reconstitution as 3 hours at room
in-use shelf-life shall be provided”. temperature while the firm has claimed 12
hours even without any data.
Justify why the test of content of sodium, Testing parameters are not completely
completeness and clarity of solution, loss on followed in stability studies only assay and
drying and sterility test is not included in the pH test is performed.
stability studies of the product.
Provide Batch Manufacturing Record (BMR) for Firm has submitted copy of BMR of the three
all the three stability batches. stability batches.
Decision of 312nd meeting of Registration Board:

Registration Board delibrated the case in detail and observed that the contract manufacturer has not
performed complete product development studies, the specifications adopted by the manufacturer
throughout stability studies were not according to USP and that the stability batches have also
expired. Accordingly, the Board deferred for following submissions:
• Drug substance specifications and analytical procedures used for routine testing of the Drug
• Scientific justification for using flow rate of 1.0ml/min for assay testing of your commercial
batches since USP recommends flow rate to be 1.5ml/min,
• Scientific justification for having analytical method of drug product without specifying that
“sample should be hold for 1-2 hours at 25± 1°C before testing” which is recommended in
USP monograph.
• Scientific justification for releasing the commercial batch of drug product and during its
stability studies even after having the value of tailing factor above 1.5, since USP
• Scientific justification for using different HPLC equipment and software for the standard
solution and the sample solution analysis.
• Scientific justification for HPLC testing of your commercial batches using UV detector at
220nm while the USP recommends that testing be performed at 300nm.
• Scientific justification for using reference / working standard having a potency of 73.91%
for the analysis of commercial batches.
• Scientific justification for having a master formulation containing 707mg of meropenem
trihydrate blended with sodium carbonate which is equivalent to 500mg meropenem.
• Provision of details including batch number, expiry date and name of manufacturer of the
innovator product along with pharmaceutical equivalence was performed.
• Scientific justification for not performing compatability studies of the drug product with the
recommended diluent.
• Scientific justification for not performing the test of sodium content and loss on drying for
the analysis of commercial batches of the drug product.
resultsof commercial batches from that specified in USP monograph.
• Scientific justification for not performing test of content of sodium, completeness and clarity
of solution, loss on drying and sterility test during the stability studies of the product.
• Scientific justification for the results of assay test of meropenem for the batch No. 17L078
which show upward trend (i.e. increase in assay values with time) throughout the stability
studies (both accelerated and real time) keeping in view the fact that the testing method was
not exactly as per USP monograph, the reference standard meropenem (trihydrate) for
injection was used instead of meropenem (base), the contents of sodium, as well as sodium
carbonate was not determined at any time point during stability studies and loss on drying
is also not performed during the stability studies.
• Evidence of purchase of atomic absorption spectrophotometer including commercial invoice
and Installation Qualification (IQ) and Operational Qualification (OQ) of atomic absorption.
• Submission of fee for pre-registration changes in the drug product specifcations.
Keeping in view the above, the Board decided that the submitted stability study data is not acceptable
and directed the manufacturer to either perform complete product development and stability studies
or submit the aforementioned data as per USP specifications and submit data accordingly. The Board
further directed the manufacturer to comply USP Specifications for already registered drug products.

Reason for deferment Response by the firm
Drug substance specifications and analytical Specifications and Analytical Procedure of Drug
procedures used for routine testing of the Drug Substance by API manufacturer is provided.
Scientific justification for using flow rate of As mentioned in USP monograph of Meropenem
1.0ml/min for assay testing of your commercial for Injection edition 2018 and 2019, retention
batches since USP recommends flow rate to be time should be between 6 to 8 minutes. We were
1.5ml/min, following same criteria regarding flow rate i.e.
1.5ml but due to typographic error flow rate of
1.0ml was mentioned in test method which has
been corrected now.
Scientific justification for having the method of Sample solution preparation was performed as
sample solution preparation for the commercial USP monograph but step of reconstitution with
batches which is entirely different from that water was not previously part of sample solution
specified in USP monograph. preparation. Said step has been incorporated in
revised test method.
Scientific justification for having analytical Due to typographic error these details of hold
method of drug product without specifying that time after sample preparation was missed in
“sample should be hold for 1-2 hours at 25± finished product testing method. Testing method
1°C before testing” which is recommended in has been revised as per current USP monograph
USP monograph.
Scientific justification for releasing the We have checked all chromatograms of raw
commercial batch of drug product and during material testing as well as stability testing but
its stability studies even after having the value found no peak tailing greater than 1.5.
of tailing factor above 1.5, since USP Particular details regarding tailing factor was not
monograph specifies tailing factor NMT 1.5 in previously mentioned in the testing method,
the system suitability requirements. which is now incorporated in revised testing
method of both drug substance and drug product.
Scientific justification for using different We use to run standard solution and sample
HPLC equipment and software for the standard solution both (whenever we perform the testing
solution and the sample solution analysis. of any API or Finished product) on same HPLC
system, as it makes results more reliable and also
verifies system suitability parameters in all-
routine testing.
We have tested assay and impurities on two
separate systems having different softwares, may
be this was confusion factor while data review.
Scientific justification for HPLC testing of We have followed USP monograph for testing of
your commercial batches using UV detector at assay of drug substance as well as impurities.
220nm while the USP recommends that testing USP monograph specifies 300nm for assay
be performed at 300nm. testing of drug substance while 220nm for
impurities testing in drug substance.
Scientific justification for using reference / The potency is on as is basis of Meropenem for
working standard having a potency of 73.91% injection, which has been standardized against
for the analysis of commercial batches. the primary standard (Meropenem base) and is
used as working standard in routine testing.
Scientific justification for having a master Below is calculation of fill weight if Meropenem
formulation containing 707mg of meropenem 1gm:
trihydrate blended with sodium carbonate As per attached COA,
which is equivalent to 500mg meropenem. Average water content = 10.5%
Average sodium bicarbonate content = 18.5%
By adding both contents, 10.5 + 18.5 = 29%

By subtracting both contents, 100% - 29% = 71%
For Merem 1g = 1000 x 100 =
1408.45mg/vial
71
Provision of details including batch number, Product Name: Merrem for injection 1g
expiry date and name of manufacturer of the Batch Number: ZEF0068
innovator product along with pharmaceutical Manufacturing Date: 09-2015
equivalence was performed. Expiry Date: 08-2019
Name of manufacturer is not mentioned.
Scientific justification why complete tests as All tests that are mentioned in USP could not
mentioned in USP monograph were not perform during pharmaceutical equivalence due
performed in pharmaceutical equivalence to limited quantity of innovator sample.
studies. Therefore, we have included only all major test
while performing pharmaceutical equivalence.
Scientific justification for not performing Compatibility studies of Merem were performed
compatibility studies of the drug product with but it was not made part of dossier during
the recommended diluent. submission. Detailed compatibility studies of
Merem against its innovator i.e. Merrem was
performed with all its recommended diluents.
Study results are also provided
Scientific justification for not performing the In 2017, we did not have Atomic Absorption
test of sodium content and loss on drying for there test of content of sodium is not part of
the analysis of commercial batches of the drug specifications of product. Moreover we have
product. now revised specification and LOD and content
of sodium has been incorporated in revised
specifications.
Scientific justification for using an entirely Formula of content of drug product is elaborated
different formula for calculation of assay with context to standard and sample preparation
results of commercial batches from that procedure which has now been updated as per
specified in USP monograph. USP format. Copy of revised test method & USP
monograph is also provided.
Scientific justification for not performing test Testing parameters like sodium contents, loss on
of content of sodium, completeness and clarity drying has not performed because they can be
of solution, loss on drying and sterility test monitored indirectly. Justifications given as
during the stability studies of the product. below:
• Sodium is the part of Sodium carbonate which
in this mixture of meropenem for injection acts
as a buffer and controls the pH of the mixture. A
pH drift will depict the change in buffer contents,
as Sodium being metal does not degrade in
ordinary conditions.
• Loss on drying has a direct impact on the
active ingredient stability/degradation. Assay
determination depicts the impact cause by this
parameter.
• In physical check of stability samples we use
to perform this test after reconstitution with
prescribed amount of water but this test was not
separately mentioned in stability data. As for as
sterility is concerned it was not part of stability
testing. We have revised our stability protocols
and included all critical Quality attributes in
stability testing and implemented for onward
stability testing.

Scientific justification how three batches have During interpretation of data from BMR while
been manufactured using 5Kg containers while preparation of dossier 5.4kg has been mistakenly
each batch required 5.4Kg drug substance. considered batch size by regulatory person.
Actual batch size as stated in BMR is 5.0kg.
Moreover meropenem as ready to fill powder is
imported in container of 5.0kg.
Evidence of purchase of atomic absorption Field Service Report dated 25-10-2019 is
spectrophotometer including commercial provided from Rays Technologies. In report it is
invoice and Installation Qualification (IQ) and mentioned that IQ, OQ and PQ of the instrument
Operational Qualification (OQ) of atomic is perfomed and the instrument is handed over to
absorption. user in working condition. However no details of
the equipment / instrument is provide.
Submission of fee for pre-registration changes Firm has submitted fee 7500/- dated 05-11-2021
in the drug product specifications. for revision of specifications.
Keeping in view the above, the Board decided Firm has not submitted product development and
that the submitted stability study data is not stability study data of new batches in which the
acceptable and directed the manufacturer to development and testing is carried out as per
either perform complete product development USP specifications from initial time point.
and stability studies or submit the
aforementioned data as per USP specifications
and submit data accordingly. The Board further
directed the manufacturer to comply USP
Specifications for already registered drug
products.
Decision of 313rd meeting of Registration Board:
Registration Board deliberated that the commercial batches manufactured by the manufacturer i.e.
Global Pharmaceuticals was not developed and tested as per the USP monograph. Keeping in view
the USP monograph, public assessment report of the innovator product and the data submitted by the
firm, the Board decided to defer the case and advised the manufacturer to perform product
development studies keeping in view the innovator product and product testing and stability studies
by complying USP monograph and submit data upon completion of 6 months stability studies.
The firm on 13-01-2022 submitted new response against the decision of 312nd meeting of
Registration Board instead of complying the decision of 313rd meeting of Registration Board.
In the new submission, the firm has changed the source of drug substance from M/s Sterile India Pvt
Ltd. India to M/s Shenzhen Haibin Pharmaceutical Co. Ltd China. Furthermore, the firm has
submitted stability data of following new batches:
Batch No. Batch size Mfg date Stability initiation

date
21A243 3538 Vials 01-2021 03-02-2021
21E154 3538 Vials 05-2021 29-05-2021
21E155 3538 vials 05-2021 29-05-2021
Firm has submitted data which shows that the product testing has been conducted as per revised specs
and calculation formula however firm has revised their specifications after 312nd meeting which was
conducted on 14-16 Septeber 2021 and the revised specifications were considered by the Board in its
313rd meeting held on 16-18 November 2021.
Deferred for submission of complete data of drug substance as well as drug product as per revised
specifications in module-2 and module-3 as per the Form 5-F guidance document
(PE&R/GL/AF/004) approved by the Registration Board.

changed the source of drug substance to CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd.
No. 88, Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei
Province PR. China. Firm has not submitted any fee for change of source as well as submission
of stability study data of new batches.
Firm has also submitted module 2 and module 3 along with stability study data, the details of which
are as under:
Manufacturer of API M/s CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd. No. 88,
Yangzi Road, Shijiazhuang Economic and Technological Development
Zone, Hebei Province PR. China.
API Lot No. 682107003
Description of Pack
Glass vial
Batch No. 22A335 21M270 21M271
No. of Batches 03
1. Reference of previous approval of The firm has referred to previous inspection of
applications with stability study data of the stability data of the same dosage form on the basis
firm (if any) of which Registration Board in 289th meeting
decided to approve registration of Promig Plus
500mg/20mg Tablet and Promig Plus
375mg/20mg Tablet.
stability chambers.
API manufacturer issued by concerned HE20180065) issued by China Food and Drugs
200Kg Meropenem for Batch No. 682107002 and
682107003. The commercial invoice is attested by

21CFR & audit trail reports on product testing of HPLC for all test intervals.
testing
accelerated)
Evaluation by PEC:
Development Zone, Hebei Province PR. China. Firm has not submitted any fee for change
of source as well as submission of stability study data of new batches.
• GMP certificate / insepection report of the contract manufacturer is not available within last
three years.
Approved.
• Registration Board decided that registration letter will be issued after submission of
applicable fee that is 75,000/- for change of source as well as submission of stability study
data of new batches as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
assessment of manufacturing and testing facility of M/s Global Pharmaceuticals (Pvt)
253. Name, address of Applicant / M/s Sami Pharmaceuticals, F-95, SITE,

Marketing Authorization Holder Karachi.
Name, address of Manufacturing site. M/s Sami Pharmaceuticals, F-95, SITE,
Karachi.
☐ Importer
giver)
☐Generic Drug Product (GDP)
☐ Export sale
Details of fee submitted PKR 50,000/-: dated 08.01.2021
D-Tres oral 400 IU Drops
name
Strength / concentration of drug of Each drop contains:
Active Pharmaceutical ingredient (API) Cholecalciferol (Vitamin D3) Ph. Eur….400
per unit IU (10µg)
Innovator Specs
Pharmaceutical form of applied drug Oral drops

Pharmacotherapeutic Group of (API) Vitamin D
ATC code: A11CC05
Innovator Specs
specifications
Proposed Pack size 10ml, 15 ml, 20 ml
SAPVIT D3 Oral Drops Solution
authorities
GMP status of the Finished product GMP Certificate issued date 11-08-2020
manufacturer
Name and address of API manufacturer. FERMENTA BIOTECH LIMITED
Plot No. Z-109 B & C, SEEZ II, Dahej
Taluka – Vagra, Distt. Bharuch 392 130
Gujarat, India
Module III (Drug Substance) Official monograph of Cholecalciferol is
present in Ph. Eur. The firm as submitted
process and controls, tests for impurity &
related substances and specifications,
substance
Real time: 5 ± 3°C for 36 months
6 months

Pharmaceutical equivalence and Pharmaceutical equivalence not performed
comparative dissolution profile due to the unavailability of the innovator
sample,
CDP is not applicable
validation/verification of product including linearity, accuracy, precision,
specificity.
Manufacturer of API FERMENTA BIOTECH LIMITED, Plot NO. Z-109B & C,

SEZ-II, DEHAJ, TAL_VAGRA, Dist. Bharuch, India
API Lot No. CLC0419047
Description of Pack
Glass bottle USP Type-III with dropper applicator
Frequency Accelerated: 0, 1,2,3,4, 6 (Months)
Batch Size 2000 ml 2000 ml 2000 ml
Manufacturing Date Jan 2020 Jan 2020 Jan 2020
No. of Batches 03
13. Reference of previous approval of The firm has submitted the relevant
applications with stability study data of document.
the firm (if any)
14. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 2062043
of API manufacturer issued by issued by Food and drug control
concerned regulatory authority of administration valid till 17/06/2023
country of origin.
with approval from DRAP (in case of specifying import of 10 kg of Cholecalciferol
import). (Batch # CLC0419047). (invoice #
RV1002000056) attested by AD (I&E),
Karachi dated 09/05/2020
sheets etc.
testing
temperature and humidity monitoring of Submitted

accelerated)
Shortcomings Reply of the firm
2.3.S.4.3 The drug product We performed assay method validation of the drug
manufacturer has substance as per CTD requirement. Validation of Impurity
performed impurity and residual solvent testing is performed by drug substance
and residual solvent manufacturer.
testing in the drug
substance. The
firm did not
perform the method
validation/verificati
on for the same
3.2.P.1 Justification/scienti Some active pharmaceutical ingredients including several
fic rationale is vitamins in certain dosage forms or packaging condition
required for may be susceptible to degrade or deteriorate and may not
addition of 20% remain their native form over the shelf life of product.
overage along with Degradation or deterioration of vitamins is one of the major
submission of factors that lead manufacturer to require excess amount of
stability assay vitamins in their products, to ensure the amount of the drug
report of the latest substance meets the requirement of 100% of the label claim
time point amount throughout the shelf life of the product. (Referred
ANNEXURE –I Pharmacopeial Forum Vol.42.42 (3)
[May-June 2016], Stimuli to the Revision Process, Factors
to Consider in Setting Adequate Overages of Vitamins and
Minerals in Dietary Supplements).
Outside the U.S., many jurisdictions recognize the
minimum value as 80-90% of label claim. For example, the
Danish and Korean authorities allow a shelf-life minimum
of 80% of label claim for added vitamins and minerals, and
the United Kingdom allows -50% for water soluble vitamins
and minerals, and -30% for oil soluble vitamins. U.S.-
designed products with inputs typically 10-50% higher than
the label claim to meet 100% minimum requirement at end
of shelf life can exceed upper specifications limits for non-
U.S. countries with maximum overage limits. (Referred
ANNEXURE –II Council for Responsible Nutrition-
Docket No.FDA-2012-N-1210; Food labelling: Revision of
the Nutrition and Supplement Facts Labels, Page No.27).
For development of our product i.e. D-Tres 400 IU/Drop,
20% overage of cholecalciferol (vitamin D3) was taken to
compensate initial process loss followed by the expected
loss in assay during stability studies. The initial test results
and stability trending of our product shows about 3% initial
process loss and 3 to 4% loss in assay under accelerated
condition as well as in long term condition.
Moreover, 20% overage was not fixed, as mentioned above,
it is a global practice to take overages for vitamins during
development studies. However, after evaluation of the
stability data and stability study report of the latest time
period i.e. 18 months it is observed that our product is stable
and no further loss in assay observed after 18 month.

(Referred ANNEXURE –III Stability trending of our
product i.e. D-Tres 400 IU/Drop).
Therefore, based on the above data and stability trend
analysis of our product, we recommend to reduce the
overage of cholecalciferol (vitamin D3) from 20% to 5%.
However, this 5% overage will not effect safety and efficacy
of product, because this 5% overage is well within the
tolerable upper intake levels recommend for Vitamin D
(Referred ANNEXURE –IV National Institutes of Health).
3.2.P.2.1 The theoretical We have developed our product D-Tres 400 IU/Drop
dispensed weight against the reference listed drug (RLD) i.e. Sapvit-D3
of cholecalciferol is 14,400 IU/ml Oral Drops, Solution (400 IU/ Drop
12,000 IU per ml marketed by M/s. Fresenius Kabi Limited UK.
(without overages), The literate data of RLD shows that one ml of RLD is
while it is 14,400 equivalent to 36 drops. 1 drop of RLD is equivalent to 400
IU (10 µg) cholecalciferol (vitamin D3). As 0.025 µg
IU per ml in the
Cholecalciferol is equivalent to 1 IU Cholecalciferol so,
reference product.
360 µg is equivalent to 14,400 IU cholecalciferol (vitamin
Justification is D3) for 36 drops which is equivalent to one ml
required Furthermore, please note that One ml of our product
contains 30 drops. However, the label claim of
Cholecalciferol per drop is same as of the RLD i.e. One
drop of our product is equivalent to 400 IU (10 µg)
cholecalciferol (vitamin D3). As 0.025 µg Cholecalciferol
is equivalent to 1 IU Cholecalciferol so, 300 µg is
equivalent to 12,000 IU cholecalciferol (vitamin D3) for 30
drops which is equivalent to one ml.
(Referred ANNEXURE –V Package leaflet: Information
for the user, Sapvit-D3 14,400 IU/ml Oral Drops, Solution
(400 IU/ Drop), page no.5)
The comparative analysis of D-Tres 400 IU/Drop against
Sapvit-D3 14,400 IU/ml Oral Drops, Solution (400 IU/
Drop) is mention below
Based on the above details we can conclude that our

product contain the same labelled amount of
cholecalciferol as of the reference listed drug (RLD) i.e.
400 IU (10 µg) cholecalciferol (vitamin D3) per drop
3.2.P.2.2. You have not The reference product is not available in Pakistan. We have
1 performed tried to arrange it from the country of origin but
pharmaceutical unfortunately not succeeded.
equivalence. Please note that the dosage form is oral solution for which
Justification is BE studies also exempted (See reference guideline of FDA
required “Guidance for Industry, Bioavailability and Bioequivalence
Studies Submitted in NDAs or INDs”,
Solutions and Other Solubilized Dosage Forms
“For oral solutions, elixirs, syrups, tinctures, or other
solubilized forms, in vivo BA and/or BE are generally self-
evident and a requirement of in vivo data for a product may

be waived (21 CFR 320.22(b)(3)). In such instances, the
applicant would be deemed to have complied with and
fulfilled any requirement for in vivo data. Although a
comparative study is not necessary, characterization of the
pharmacokinetics of the drug is required (21 CFR
314.50(d)(3)). In addition, in vivo BE studies that compare
different solution formulations are waived based on the
assumptions that release of drug substance from the drug
product is self-evident and that the solutions do not contain
any excipients that significantly affect drug absorption.
However, there are certain excipients that may alter the BA
(e.g., sorbitol may reduce the BA of drugs, and vitamin E
may enhance the BA) in amounts sometimes used in oral
liquid dosage forms. In this case, evaluation of in vivo BA
and/or BE may be required”.
Please also note that our formulation is similar to the
innovator in the following,
1. API: Same as that of Reference listed drug.
2. Dosage form: Same as that of Reference listed drug.
3. Indication: Same as that of Reference listed drug.
4. Excipients: Same as that of Reference listed drug .
5. Label claim: Same as that of Reference listed drug.
However, for assay and other chemical / microbiological
attributes, we have tested the product according to the
general monograph of pharmacopeia and complied.
3.2.P.4.1 The coconut oil is Yes, it is available in BP and testing was done according to
available in the BP specifications. As per our procedure for excipients,
pharmacopeia. The we do not mention the material reference on the
drug product specifications.
manufacturer has The missing Chromium test performed and incorporated in
claimed in-house our specifications.
specifications; and
did not perform the
chromium test.
Justification is
required
3.2.P.5.1 Pharmacopeial Pharmacopeial monograph for the Cholecalciferol solution
monograph for the has the different vehicle / solvent from the innovator and our
Cholecalciferol formulation is based on reference listed drug (RLD), which
solution has the using only API and medium chain triglyceride (coconut oil).
different vehicle / Therefore we cannot claim it Pharmacopeial and claim it as
solvent from the Innovator specifications.
innovator and our Please see below the difference of the formulations
formulation is Pharmacopeia Innovator SAMI
based on reference edible vegetable Medium chai Medium chai
listed drug (RLD), oil triglyceride triglyceride
which using only (Fractionated (Fractionated
API and medium coconut oil) coconut oil)
chain triglyceride Polysorbate 80 or - -
(coconut oil). Propylene Glycol - -
Therefore we
cannot claim it
Pharmacopeial and
claim it as

Innovator
specifications.
3.2.P.5.1 Filled We have already performed filled volume test but not
volume/weight submitted to you as this is the part of our in-process testing.
variation test has Please find attached the in-process report for your ready
not been performed reference
3.2.P.5.2 The applied drug As already mentioned in 3.2.P.5.1, the product available in
product is available pharmacopeia has different vehicle / solvent from the
in pharmacopeia. innovator. Our formulation is based on innovator.
The drug product Therefore, we use the in-house developed, validated
manufacturer has method.
validated their own
testing method for
the assay.
Justification is
required
3.2.P.5.6 The drug product Pharmacopoeia tests are the minimum requirement. As per
manufacturer has general pharmacopoeial monograph, additional tests can be
performed performed according to the nature of substance and
additional tests considering the formulation.
(other than those
mentioned in the
pharmacopeia).
The specifications
for such tests shall
be justified
3.2.P.8.3 You shall clarify The product is placed in inverted position.
whether the
stability was
conducted placing
the bottles upright
or inverted
• Pharmaceutical equivalence studies of the applied product along with innovator /
reference product.
• Evidence of approval of applied formulation as a pharmaceutical drug product in
reference regulatory authorities / agencies which were adopted by the Registration
Board in its 275th meeting.
• Scientific justification that the applied formulation is equivalent to the innovator’s
product in terms of cholecalciferol contents per ml as well as per drop.
Sr. Reason for deferment Response by the firm

No
1. Pharmaceutical equivalence studies We have developed our product D-Tres 400
of the applied product along with IU/Drop against the reference listed drug
innovator / reference product. (RLD) i.e. Sapvit-D3 Oral Drops solution
(400 IU/ Drop) marketed by M/s. Fresenius
Kabi Limited UK.
However, due to unavailability of the
reference product, pharmaceutical
Equivalence has been performed against

Baby Ddrops 400IU per drop - which is
similar to our formulation
Reference Document attached
https://health-products.canada.ca/lnhpd-
bdpsnh/index-eng.jsp
2. Evidence of approval of applied Sapvit-D3 400 IU/drop oral drops,
formulation as a pharmaceutical drug solution
product in reference regulatory Qualitative and Quantitative
authorities / agencies which were Composition
adopted by the Registration Board in One ml (= 36 drops) contains: 14,400 IU
its 275th meeting. (360 microgram) cholecalciferol (vitamin
D3) One drop = 400 IU (10 microgram)
cholecalciferol (vitamin D3)
Health Products Regulatory Authority
(HPRA) Ireland
3. Scientific justification that the SmPC of the Innovator product clearly
applied formulation is equivalent to mentions that 1 drop is equivalent to 400IU
the innovator’s product in terms of The Leaflet & SmPC of the Innovator
cholecalciferol contents per ml as product SAPVIT D3 mentions the following
well as per drop. dosage guidelines:
The Method of administration mentions
that the best way to take Sapvit-D3 oral
drops is to add them drop by drop into the
mouth or, if necessary, administer with a
spoon and some liquid.
Prevention of vitamin D deficiency:
The usual daily dose is:
For newborns, infants and children from the
second week of life to the age of 3 years:
between 1-2 drops
For children aged 4 years and above and
adolescents: between 1-3 drops
For adults aged 19 to 70 years: between 1-4
drops
For elderly people aged above 70 years:
between 2-4 drops
Treatment of rickets
The total amount of required vitamin D
depends on the severity of the disease.
In existing rickets, treatment is started with a
preparation with a higher concentration of
vitamin D for the initial treatment.
Subsequently, the usual dose is between 2 to
12 drops of Sapvit-D3 daily.
Treatment of vitamin D deficiency
For children and adolescents: 5 drops daily
for 6 weeks, then between 1-3 drops daily
For adults aged 19 to 70 years and elderly
people aged above 70 years: 15 drops daily
for 8 weeks, then
between 3-5 drops daily
Adjunct to osteoporosis treatment of
patients who are at risk of vitamin D
deficiency

For adults aged 19 years and above: between
2-4 drops daily or between 14-26 drops
weekly.
Based on the dosage guidelines for
multiple conditions as mentioned above,
SAPVIT D3 is available in 12.5 ml
(corresponding to 450 drops) or 25 ml
(corresponding to 900 drops), whereas
our product D-Tres Oral Drops applied
pack size is 10ml.
The literate data of RLD shows that one ml

of RLD is equivalent to 36 drops. 1 drop of
RLD is equivalent to 400 IU (10 µg)
cholecalciferol (vitamin D3). As 0.025 µg
Cholecalciferol is equivalent to 1 IU
Cholecalciferol so, 360 µg is equivalent to
14,400 IU cholecalciferol (vitamin D3) for 36
Furthermore, please note that One ml of our

product contains 30 drops. However, the
label claim of Cholecalciferol per drop is
same as of the RLD i.e. One drop of our
product is equivalent to 400 IU (10 µg)
cholecalciferol (vitamin D3). As 0.025 µg
Cholecalciferol is equivalent to 1 IU
Cholecalciferol so, 300 µg is equivalent to
12,000 IU cholecalciferol (vitamin D3) for 30
Finally, the firm summarized that their per

drop content is same as that of the reference
product.
Decision: Deferred for following points:
• Clarification since the concentration of Cholecaliferole per mL of the innovator’s
product is 360ug (Eq. to 14,440IU) while the applied product contains 30ug
(12,000IU) per mL.
• Confirmation of RDA value for Cholecalciferole.
254. Name, address of Applicant / M/s Aspin Pharma (Pvt) Ltd. Plot No. 10
Marketing Authorization Holder & 25 Sector 20, Korangi Industrial Area
Karachi.
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals (Pvt) Ltd. 581,
Sundar Industrial Estate, Raiwind Road
Lahore.
☐ Importer
giver)

GMP status of the firm Stallion Pharmaceuticals: Firm has
submitted GMP certificate issued on the
basis of inspection dated 22-09-2020.
No 000783 of M/s Stallion Pharma
powder injection Vial (carbapenem) section.
☐ Export sale
The proposed proprietary name / brand ASPINEM 500mg Injection
name
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……500mg
Pharmaceutical form of applied drug White or almost white, hygroscopic,
crystalline, powder filled in clear glass vials
specifications
authorities
Name and address of API manufacturer. M/s Aurobindo Pharma Limited Unit-V, Plot
No. 68-70, 73-91, 95, 96, 260, 261 I.D.A
Chemical Zone, Pashamylaram, Patancheru
Mandal, Sanga Reddy District Telangana,
India.

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.
Pfizer Pakistan Ltd.
Manufacturer of API M/s Aurobindo Pharma Limited Unit-V, Plot No. 68-70, 73-91, 95,
96, 260, 261 I.D.A Chemical Zone, Pashamylaram, Patancheru
Mandal, Sanga Reddy District Telangana, India.
API Lot No. 1705205135
1705205096
1705203623
Description of Pack
Glass vial

Batch No. T7003 T7004 T7005
No. of Batches 03
DATA
1. Reference of previous approval of No response submitted by the firm
firm (if any)
API manufacturer issued by concerned (No. 3298/E1/2019) issued by Drugs Control
regulatory authority of country of origin. Administration, Government of Telangana
testing
6. Record of Digital data logger for Not submitted
accelerated)
Evaluation by PEC:
• Firm has submitted fee 70,000 for the application of contract manufacturing

Submit data in section 3.2.S.4.1 as per the Firm has submitted copy of analytical method
guidance document approved by Registration of drug substance from the drug product
Board which specifies that “Copies of the manufacturer. The analytical method is issued
Drug substance specifications and analytical on 20-07-2021.
Ingredient by both Drug substance & Drug
Submit data in section 3.2.S.4.3 as per the Firm has submitted report of verification
decision of 293rd meeting of Registration studies of the analytical method of drug
Board, which states that “Analytical Method substance. However, the verification studies
Verification studies including specificity, were conducted on 21-01-2021 while the
accuracy and repeatability (method precision) analytical method of drug substance was
performed by the Drug Product manufacturer issued by the drug product manufacturer on
for both compendial as well as non- 20-07-2021.
compendial drug substance(s) shall be

submitted”. Further justify how the analysis
of drug substance was conducted without
Submit data in section 3.2.S.4.4 as per the Firm has submitted COA of the drug
guidance document approved by Registration substance generated by drug product
Board which specifies that “Provide results of manufacturer only, while the COA of drug
analysis of relevant batch(es) of Drug substance manufacturer is not submitted.
Substance performed by Drug Product
manufacturer used during product
development and stability studies, along with
Certificate of Analysis (CoA) of the same
batch from Drug Substance / /Active
Pharmaceutical Ingredient manufacture. A
discussion and justification shall be provided
for any incomplete analyses of the drug
substance / API by Drug Product
manufacturer (e.g. results not tested according
to the proposed specification)”.
Submit COA of reference standard / working Firm has submitted COA of working standard
standard including source and lot number from drug substance manufacturer which has
which is actually used in the testing of drug been standardized against USP reference
substance and drug product. standard.
However drug product manufacturer is using
working standard of meropenem Batch No.
SI/MPM/00060120 manufactured by M/s
Sterile India.
Justify the master formulation containing Firm has submitted calculation to justify the
570mg of meropenem trihydrate for filled weight. As per calculations submitted
manufacturing of 500mg meropenem for by the firm the weight 570mg per vial is
injection, since the drug substance contains calculated on theoretical basis considering
meropenem blended with 15.10 to 16.50% that the drug substance has 100% assay, while
w/w of sodium carbonate. the actual dispensing is to be made on the
basis of actual % assay of the meropenem.
Justify the use of 5% overage in the We hereby justify that in development stage
formulation, since the justification submitted we added 5% extra meropenem sterile powder
in this regard is not supported by any for injection in initial batches. After
guidelines. completion of stability study degradation is no
more than 2 – 3% within the limit assay range
is 90 – 120% so no more 5% meropenem
sterile powder for injection is added.
Submit results of compatibility studies in Firm has submitted result of compatibility
section 3.2.P.2.6. studies of the drug product with WFI.
Justify how the time and temperature of Firm has submitted summary report of
sterilization cycle is directly selected without autoclave machine re qualification instead of
any protocols for its validation. providing justification.
Provide detailed method of sample stock Firm has not submitted complete method of
solution preparation instead of mentioning the analysis of the drug product in which the
general statement “Constitute a container of method of sample solution preparation is
Meropenem for Injection with a volume of explained.
water, corresponding to the quantity of
solvent specified in the labelling”.
Justify why the formula for calculation of Firm has submitted that we are using potency
assay contents of meropenem is different than of working standard as percentage. USP
that mentioned in USP monograph. taking the potency in mg/mg which is

converted into percentage by multiplying this
ratio with 100. Firm has submitted calculation
to justify that their formula is equivalent to
USP.
However, the USP formula used by the firm
is different from that specified in USP.
Analytical method verification studies have Firm has submitted verification studies of the
not been conducted and evaluated in the light analytical method dated 21-01-2021, while
of USP general chapters and ICH guidelines. the analytical method of the drug product was
revised and updated on 12-07-2021.
Justify why the drug product specifications In Meropenem trihydrate injection label claim
does not contain the test for sodium contents is as meropenem while trihydrate and sodium
as recommended by USP. considered as impurity. We are verifying the
meropenem by HPLC and due to
unavailability of the atomic absorption we
were verifying the sodium content by titration
method. Moreover, for verification purpose,
we analysed sodium content from PCSI and
Citi Pharma with atomic absorption. And now
we have atomic absorption in our facility and
we have changed our SOP accordingly and
now we are conducting each and every
analysis of sodium content in our facility as
per USP monograph.
Justify the test of accuracy in analytical Firm has submitted that we had performed the
method validation without specifying the accuracy by making a concentration of
concentrations of the solution which are standard preparation and three concentrations.
analysed for accuracy. Further justify the use The concentrations used by the firm for
of solutions having low, medium, and high accuracy test is 0.16mg/ml, 0.20mg/ml and
concentration of sample without specifying 0.24mg/ml.
their exact concentration. Such words are not As per the analytical method the standard
recommended by any scientific guidelines. solution concentration is 0.11mg/ml and the
concentration used by the firm to study
accuracy does not include the said
concentration.
Linearity and range have been studied from Two different samples were prepared for
70% to 120% of the solution wherein the area linearity and accuracy parameter of analytical
under curve for 100% solution was 4691449 method verification, for linearity parameter
while in accuracy studies in the same method from the first dilution 6 further second
none of the solution (either low, medium or dilutions 70%, 80%, 90%, 100%, 110% and
high concentration) achieved such area 120% were prepared while in accuracy 3
although the concentration of the solution is further second dilutions low, medium and
expected to be the same. Justification is high were prepared. Because the weights of
required in this regard. the sample are different in linearity and
accuracy parameters that’s why the area
achieved is different for both parameters.
In linearity studies the area under curve for In linearity the sample solution preparation is
100% solution was 4691449, while in stability different from the sample preparation of
studies the area under curve of the sample finished product. In linearity a concentration
solution having exactly same concentration is of standard taken to prepare first dilution then
reported to be 11769485. Justification is make second dilution by taking 7ml, 8ml,
required in this regard how such huge 9ml, 10ml, 11ml, 12ml from the first dilution,
difference in area under the curve can exist in second dilution of 10ml is considered as
the analysis and how this method can be 100% concentration while in finished good
considered reliable and verified. the dilution contain 100mg of sample that’s

why area under curve for 100% solution is
different from the area of 100mg in finished
product.
The analytical method verification studies In 2017, we had completed analytical method
have been conducted in January 2021 while verification by performing three parameters
the batches were manufactured in 2017. which are linearity, system suitability and
Justification is required in this regard. specificity while when we submit the CTD
dossier we came to know the DRAP
requirement of accuracy and repeatability,
then we had complete the analytical method
verification by performing five parameters
which are linearity, system suitability,
specificity accuracy and repeatability.
Justify the limit of sodium content in the in In past we were doing sodium content
house generated COA of drug substance, in analysis by titration method (due to
which limit of sodium content is taken as unavailability of AAS) the result was 9.12%
6.0% to 9.3% and the drug substance was limit of sodium content is 6.0% - 9.3% while
passed on the basis of results of 9.12%, while the drug substance manufacturer specifies the
the drug substance manufacturer specifies the sodium content as 6.65 to 7.20%. Now we are
limit of sodium content as 6.56% to 7.20%. doing sodium content with AAS according to
USP.
As per the submitted results of sodium content Firm has not submitted any justification
in meropenem injection by CITI Pharma, the
results of % sodium content is 7.867%, while
USP specifies the acceptance criteria to be
80%–120% of the labeled amount of sodium.
Justify how your results complies USP
specifications keeping in view the labelled
amount of sodium in your product.
Justify the use of commercial lot of The assay of meropenem trihydrate USP
meropenem for injection as working standard reference standard lot# J0K434, is 87.3%
since USP recommends that reference meropenem. Similarly by comparing with
standard should be pure meropenem reference standard we prepare our
trihydrate. meropenem trihydrate working standard in
which 82.12% is meropenem present.
Actually the material used in USP Reference
standard and the working standard is the same
as meropenem trihydrate because the product
label claim is meropenem, therefore we have
to calculate the assay against the purity of
material as meropenem which is 87.3% in
USP Reference standard and 82.12% in
working standard.
Provide details that which lot number of drug Firm has not submitted details that which lot
substance has been used in manufacturing of number of drug substance has been used in
each batch of drug product. Also provide manufacturing of each batch of drug product.
documents confirming evidence of import of Further documents confirming import of these
each lot of drug substance used in relevant batches are also required.
manufacturing of these batches of drug
product.
Provide data of stability batches properly Firm has not yet submitted stability study data
arranged and supported by respective in proper sequence with COA for each time
documents including analytical report / COA, point, raw data sheets and chromatograms.
raw data sheet and respective chromatograms Raw data sheets are not submitted. Further the
separately for each time point, since the calculation formula used for the calculation of

submitted chromatograms and analytical assay result is also different from USP as well
reports are without any proper sequence. as the method of sample and standard solution
preparation.
Provide Reference of previous approval of No response submitted by the firm
firm (if any)
Provide compliance Record of HPLC No response submitted by the firm
software 21CFR & audit trail reports on
product testing.
Provide Record of Digital data logger for No response submitted by the firm
stability chambers (real time and accelerated).
• Submission of differential fee as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021.
• Submission of COA of relevant batch of drug substance from drug substance
manufacturer used in the manufacturing of batches for which stability study data is
submitted.
• Scientific justification for using commercial batch manufactured by M/s Sterile India as
working standard.
• Scientific justification for use of 5% overage in the formulation.
• Submission of complete protocols of process validation studies of the drug product.
• Submission of detailed method of analysis of the drug product with details of sample
solution preparation.
• Scientific justification for using calculation formula for assay testing which is different
from that specified in USP monograph.
• Revision of drug product specifications in the light of USP monograph and inclusion of
test for sodium content along with submission of fee of Rs. 7,500 for correction/pre-
approval change/ in product specifications, as per notification No.F.7-11/2012-
• Scientific justification for the analytical method verification studies of the drug product
which is not performed as per ICH guidelines.
• Submission of stability study data of three commercial batches in section 3.2.P.8.3 as per
the 6-points checklist provided in Form 5-F guidance document (PE&R/GL/AF/004)
approved by the Registration Board.
No
1. Submission of differential fee as per Firm has submitted differential fee 5,000/-
notification No.F.7-11/2012- vide slip number 551237597908 dated 20-
B&A/DRAP dated 13-07-2021. 05-2022.
2. Submission of COA of relevant batch Firm has submitted COA of relevant batch of
of drug substance from drug substance drug substance generated by drug substance
manufacturer used in the manufacturer.
manufacturing of batches for which
stability study data is submitted.
3. Scientific justification for using This firm has submitted that the assay of
commercial batch manufactured by Meropenem Trihydrate USP reference
M/s Sterile India as working standard. standard lot # J0k434 is 87.3%. Therefore,
we used sterile India material as working
Standard having potency 82.02% by using
standardization procedure with USP
reference standard. Material used for batch

manufacturing is from Aurobindo China and
working standard prepared is of Sterile India
having Potency 82.02%
COA’s for Reference standard & working
standard along with standardization
procedure is submitted by the firm.
4. Scientific justification for use of 5% Firm has submitted that an overage is used to
overage in the formulation. cover losses during manufacturing. Initially
we used extra 5% of Meropenem to deliver
our product with exact quantity of API in
injection, the idea behind was to
deliver exact quantity of the active
substance. After that our product was stable
throughout its
shelf life so no need to add extra 5% overage.
In general, use of an overage of a drug
substance to compensate for degradation
during manufacture or a product's shelf life,
or to extend shelf life, is discouraged.
Overages are nothing but the extra quantity
of material taken, which is lost during
process stage.ICH Q8 guide line, provide a
structured way to define product critical
quality attributes. We are not using any
overage in the manufacturing of Meropenem
injection
5. Submission of complete protocols of Firm has submitted general protocols for
process validation studies of the drug process validation. Firm has not submitted
product. specific protocols for the process
validation of applied product.
6. Submission of detailed method of Firm has submitted detailed method of
analysis of the drug product with analysis of the drug product, However in the
details of sample solution preparation. submitted method, sample solution
preparation method is still not clear in
terms of exact volume of water used to
reconstitute the contents of vial and then
how to make further dilutions.
Furthermore, the calculation formula use
weight of sample and standard while USP
recommends to use concentration of sample
and standard.
7. Scientific justification for using Firm has submitted that they are using the
calculation formula for assay testing potency of working standard as percentage.
which is different from that specified USP taking the
in USP monograph. Potency into mg/mg which is covered into
percentage multiplying the ratio with 100 so
there is no difference between the USP
formula & our standard operating formula
further more we have amended our SOP with
respect to the formula given in USP.
However, the newly used calculation
formula use weight of sample and
standard while USP recommends to use
concentration of sample and standard.

The new formula is also not exactly as per
USP monograph.
8. Revision of drug product Firm has now added sodium content test in
specifications in the light of USP their specifications. Firm has also submitted
monograph and inclusion of test for fee 7,500/- vide slip number 212267176
sodium content along with submission dated 20-05-2022.
of fee of Rs. 7,500 for correction/pre- However, no data regarding the sodium
approval change/ in product content testing during stability studies is
specifications, as per notification provided.
No.F.7-11/2012-B&A/DRAP dated
13-07-2021.
9. Scientific justification for the Firm has not justified the previous validation
analytical method verification studies reports, instead the firm has submitted new
of the drug product which is not report in which the analysis is carried out on
performed as per ICH guidelines. July 2022. The new report was performed in
line with ICH recommendations.
10. Submission of stability study data of Firm has submitted data in section 3.2.P.8.3.
three commercial batches in section The evaluation os submitted data is as under:
3.2.P.8.3 as per the 6-points checklist
provided in Form 5-F guidance
document (PE&R/GL/AF/004)
Reference of previous approval of Not applicable

the firm (if any)
Approval of API/ DML/GMP certificate Firm has submitted copy of GMP
of API manufacturer issued by certificate (No. 3298/E1/2019) issued by
concerned regulatory authority of Drugs Control Administration,
country of origin. Government of Telangana dated 11-02-
2020. The certificate is valid till 3 years
from the date of issue.
Documents for the procurement of API 1705205135, 1705205096:
with approval from DRAP (in case of Firm has submitted copy of commercial
import). invoice cleared dated 19-10-2017
specifying import of 20Kg meropenem for
lot number 1705205135, 1705205096.
The invoice is cleared by AD (I&E)
DRAP.
1705203623:
invoice cleared dated 12-09-2017
lot number 1705203623. The invoice is
Data of stability batches will be Firm has submitted analytical record of
supported by attested respective product testing including HPLC
documents like chromatograms, Raw chromatogram and raw data sheets
etc.
Compliance Record of HPLC software Not submitted
testing

Record of Digital data logger for Firm has submitted record of digital data
temperature and humidity monitoring of logger for stability chambers for
stability chambers (real time and accelerated and real time stability study.
accelerated)

• Clarification for use of 5% overage in sterile products and specifications of the
manufactured products in the light of approved specifications and pharmacopoeial
monographs.
• Capacity assessment of manufacturing and testing facility of M/s Stallion
Pharmaceuticals (Pvt) Ltd. 581, Sundar Industrial Estate, Raiwind Road Lahore.
• Submission of specific protocols for the process validation of applied product.
• Submission of preparation sample solution is required since it is not clear in terms
of exact volume of water used to reconstitute the contents of vial and then how to
make further dilutions. Furthermore, the calculation formula use weight of sample
and standard while USP recommends to use concentration of sample and standard.
• Clarification regarding use of formula which is different from the formula as
recommended by USP for calculation of assay.
255. Name, address of Applicant / M/s Aspin Pharma (Pvt) Ltd. Plot No. 10
Marketing Authorization Holder & 25 Sector 20, Korangi Industrial Area
Karachi.
Lahore.
☐ Importer
giver)
GMP status of the firm Stallion Pharmaceuticals: Firm has
☐ Export sale

The proposed proprietary name / brand ASPINEM 1g Injection
name
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……1g
specifications
authorities
No. 68-70, 73-91, 95, 96, 260, 261 I.D.A
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

API Lot No. 1705205135
1705205096
1705203623
Description of Pack
Glass vial
Batch No. U7003 U7004 U7005
No. of Batches 03
DATA
firm (if any)

testing
accelerated)
Evaluation by PEC:
• Firm has submitted fee 70,000 for the application of contract manufacturing


Sterile India.
manufacturing of 1g meropenem for injection, by the firm the weight 1140mg per vial is
since the drug substance contains meropenem calculated on theoretical basis considering
blended with 15.10 to 16.50% w/w of sodium that the drug substance has 100% assay, while
carbonate. the actual dispensing is to be made on the
USP.

per USP monograph.
concentration.
product.
sodium content as 6.65 to 7.20%. Now we are

the drug substance manufacturer specifies the doing sodium content with AAS according to
limit of sodium content as 6.56% to 7.20%. USP.
meropenem for injection (batch number reference standard lot# J0K434, is 87.3%
SI/MPM/00060120) manufactured by sterile meropenem. Similarly by comparing with
India as working standard since USP reference standard we prepare our
recommends that reference standard should meropenem trihydrate working standard in
be pure meropenem trihydrate. which 82.12% is meropenem present.
working standard.
product.
preparation.
firm (if any)
product testing.
• Submission of differential fee as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021.

submitted.
working standard.
No
1. Submission of differential fee as per Firm has submitted differential fee 5,000/-
notification No.F.7-11/2012- vide slip number 658476562996 dated 20-
B&A/DRAP dated 13-07-2021. 05-2022.
throughout its

injection
and standard.
USP monograph.
13-07-2021.


the firm (if any)
lot number 1705205135, 1705205096.
DRAP.
1705203623:
etc.
testing
accelerated)
monographs.


Road Lahore.
Lahore.
☐ Importer
giver)
GMP status of the firm Genetics Pharmaceuticals: Firm has
submitted copy of GMP certificate issued on
the basis of inspection dated 29-03-2019.
Stallion Pharmaceuticals: Firm has
☐ Export sale
The proposed proprietary name / brand MEROTOL 500mg Injection
name
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……500mg
specifications

authorities
No. 68-70, 73-91, 95, 96, 260, 261 I.D.A
India.
product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.

API Lot No. 1705205135
1705205096
1705203623
Description of Pack
Glass vial
Batch No. T7003 T7004 T7005
No. of Batches 03
DATA
firm (if any)
testing
accelerated)
Evaluation by PEC:

Submit differential fee for the registration of Firm has submitted copy of fee challan dated
applied product, since the notification for 28-10-2021 for 25,000/- vide slip number
revision of fee vide SRO No. F.7-11/2012- 08343787921
B&A/DRA was published on 7th May 2021
while this application was received in R&I
section of DRAP on 20th May 2021.
Sterile India.
manufacturing of 500mg meropenem for by the firm the weight 570mg per vial is
injection, since the drug substance contains calculated on theoretical basis considering
meropenem blended with 15.10 to 16.50% that the drug substance has 100% assay, while
w/w of sodium carbonate.

the actual dispensing is to be made on the
USP.
per USP monograph.

concentration.
product.
USP.
meropenem for injection as working standard reference standard lot# J0K434, is 87.3%
since USP recommends that reference meropenem. Similarly by comparing with

standard should be pure meropenem reference standard we prepare our
trihydrate. meropenem trihydrate working standard in
which 82.12% is meropenem present.
working standard.
product.
preparation.
firm (if any)
product testing.
submitted.
working standard.

•
Submission of stability study data of three commercial batches in section 3.2.P.8.3 as per

No
throughout its
injection

and standard.
USP monograph.
13-07-2021.

the firm (if any)

lot number 1705205135, 1705205096.
DRAP.
1705203623:
etc.
testing
accelerated)
monographs.
Road Lahore.
Lahore.
☐ Importer
giver)
29-10-2020 is submitted

GMP status of the firm Genetics Pharmaceuticals: Firm has
submitted copy of GMP certificate issued on
the basis of inspection dated 29-03-2019.
Stallion Pharmaceuticals: Firm has
☐ Export sale
The proposed proprietary name / brand MEROTOL 1g Injection
name
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……1g
specifications
authorities
No. 68-70, 73-91, 95, 96, 260, 261 I.D.A
India.

product.
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65 ± 5% RH for 36 months.
API Lot No. 1705205135
1705205096
1705203623
Description of Pack
Glass vial

Batch No. U7003 U7004 U7005

No. of Batches 03
DATA
firm (if any)
testing
accelerated)
Evaluation by PEC:

Submit differential fee for the registration of Firm has submitted fee challan dated 28-12-
applied product, since the notification for 2021 for 25,000/- vide slip number
revision of fee vide SRO No. F.7-11/2012- 16540367178
B&A/DRA was published on 7th May 2021
while this application was received in R&I
section of DRAP on 11th June 2021.

Sterile India.
manufacturing of 1g meropenem for injection, by the firm the weight 1140mg per vial is
since the drug substance contains meropenem calculated on theoretical basis considering
blended with 15.10 to 16.50% w/w of sodium that the drug substance has 100% assay, while
carbonate. the actual dispensing is to be made on the

USP.
per USP monograph.
concentration.

product.
USP.
meropenem for injection (batch number reference standard lot# J0K434, is 87.3%
SI/MPM/00060120) manufactured by sterile meropenem. Similarly by comparing with
India as working standard since USP reference standard we prepare our
recommends that reference standard should meropenem trihydrate working standard in
be pure meropenem trihydrate. which 82.12% is meropenem present.
working standard.
product.

preparation.
firm (if any)
product testing.
submitted.
working standard.
No

throughout its
injection
and standard.

USP monograph.
13-07-2021.

the firm (if any)
lot number 1705205135, 1705205096.
DRAP.
1705203623:
etc.
testing

accelerated)
monographs.
258. CAPACITY ASSESSMENT INSPECTION REPORT OF M/S VISION

PHARMACEUTICALS (PVT.) LTD
GENERAL INFORMATION
Name of manufacturer M/s. Vision Pharmaceuticals (Pvt.) Ltd

Physical Address Plot No. 22 – 23, Industrial Triangle Kahuta Road, Islamabad
DML No. 000517
Date of inspection 15.06.2022
Assessment and confirmation of manufacturing capacity with
Purpose of inspection
reference to DRAP, Islamabad letter No.
Dosage Form/Sections I. Sterile Dry Powder Injection Vial (GENERAL)
Included II. Sterile Dry Powder Injection Vial (STEROID)
I. Muhammad Haseeb Tariq, Assistant Director PEC, PE&R
Name of inspector (s) Division.
II. Dr Farhadullah, Assistant Director PEC, PE&R Division.
Name of Firm’s
Representative (s) I. Dr. Waseem Shahzad (Head of Quality Operations)
accompanying during II. Mr. Shaukat Iqbal (Manager Quality Control)
inspection
Manufacturing and testing record/data was evaluated from January 2021 to December 2021 for the
said purpose. The details of capacity calculations are as under:
NUMBER OF PRODUCTS MANUFACTURED BY THE FIRM
No of products
No of products
registered for
Category registered for self- Total
contract
manufacturing
manufacturing

Sterile Dry Powder Injection
15 17 32
Vial (General)
Sterile Dry Powder Injection
04 00 04
Vial (Steroid)
Total products 19 17 36
SECTION WISE MANUFACTURING CAPACITY
1. CAPACITY OF STERILE DRY POWDER INJECTION VIAL (GENERAL)
Step wise capacity of Sterile Dry Powder Maximum production Capacity (vials)
Injection Vial (GENERAL)
Per day Per month
(8 hour working shift) (26 working days)
Vial Washing -
25,000 650,000
Per single shift of 8 working hours (Load per Day)
Depyrogenation Capacity-
35,826 931,476
Per Single shift of 8 working hours (Load per Day)
Filling and Sealing Capacity –
30,000 780,000
Packing Capacity –
20,000 520,000
Note: Limiting step in this process is Packing for calculating Utilized Capacity.
Quarter Wise capacity utilized in Sterile Dry Powder Injection Vial (GENERAL)
Actual
Capacity Capacity
Quarter Production
(Vials) utilized in (%)
(Vials)
I (1st January – 31st March 2021) 474,030 1,560,000 30.3 %
II (1st April – 30th June 2021) 871,948 1,560,000 55.8 %
III (1st July – 30th September 2021) 430,320 1,560,000 27.5 %
IV (1st October – 31st December 2021) 741,563 1,560,000 47.5 %
Average Capacity Utilized for January – December 2021 in % 40.27 %
Manufacturing Capacity Utilized (average): 40.27 %

Manufacturing Capacity Available (average): 59.72 %
2. CAPACITY OF STERILE DRY POWDER INJECTION VIAL (STEROID)
Step wise capacity of Sterile Dry Powder Maximum production Capacity (vials)
Injection Vial (STEROID)
Per day Per month
(8 hour working shift) (26 working days)
Vial Washing -
40,000 1,040,000
Depyrogenation Capacity-
40,000 1,040,000
Per Single shift of 8 working hours (Load per Day)

Filling and Sealing Capacity –
40,000 1,040,000
Packing Capacity –
20,000 5,20,000
Note: Limiting step in this process is Packing for calculating Utilized Capacity.
Quarter Wise capacity utilized in Sterile Dry Powder Injection Vial (STEROID)
Actual
Capacity Capacity
Quarter Production
(Vials) utilized in (%)
(Vials)
I (1st January – 31st March 2021) 194,418 1,560,000 12.4%
II (1st April – 30th June 2021) 96,955 1,560,000 6.21%
III (1st July – 30th September 2021) 278,531 1,560,000 17.85%
IV (1st October – 31st December 2021) 197,903 1,560,000 12.68%
Average Capacity Utilized for January – December 2021 in % 12.28%
Manufacturing Capacity Utilized (average): 12.28%

Manufacturing Capacity Available (average): 87.71%
CAPACITY OF QUALITY CONTROL DEPARTMENT
Quality Control Equipment Detail

Sr. No Equipment Qty. Capacity per day (tests)
1. HPLC Hitachi (Auto Sampler) 1 03
2. HPLC Waters (Auto Sampler) 1 03
3. HPLC Waters (Auto Sampler) 1 03
4. HPLC Shimadzu 1 02
5. HPLC Shimadzu 1 02
6. Spectrophotometer 1 20
7. Sterility Testing 1 Lab 12
8. Moisture Analyzer 1 50
Total Organic carbon 10
9. 1
Analyzer
10. Karl Fischer 1 30
11. pH meter 2 100
12. Conductivity Meter 1 50
13. Weighing balance 2 100
14. Liquid particle Counter 1 50

Hot Incubator (30- 35oC) 175
15. 1
750 Liters

Cool Incubator (20- 25oC) 750
16. 1
750 Liters
17. 1
108 Liters
18. 1
100 Liters
Hot Incubator (55- 60oC) Only for BET
19. 1 300
74 Liters
Cool Incubator (20- 25oC) 150
20. 1
126 Liters
Hot Incubator 37oC + 1 oC For Biological Indicators
21. 1
74 Liters
22. Dry Heat Sterilizer 250 oC 1 200
23. Refrigerator 1 -----
24. Autoclave 1 10
25. Autoclave 1 10
26. Air born particle counter 1 50
27. Air sampler 1 50
28. FTIR 1 20
29. Polarimeter 1 15
30. Dissolution Apparatus 3 15
31. Stability Chamber (Accelerated) 2 600L
32. Stability Chamber (Real time) 5 1500L
The details of the total registered products of the firm with respect to the method of testing is provided
below:
Total No of No of Products No of Products No of product No of products
registered with official with In- currently on to be shifted to
Products Monograph house/Innovator HPLC HPLC
(USP/BP/JP) specs
36 08 USP/03 BP 25 36/ 36 currently NA
The firm has two separate Drug Manufacturing License i.e. DML by way of formulation and
DML by way of semi-basic manufacturing, however the firm has a single QC laboratory which
caters for all stages of testing for all type of products manufactured in both licensed facilities.
HPLCs Capacity Calculation Quarter Wise

(Average 2 – 3 tests/day/HPLC)
TOTAL 05 HPLC (13 tests per day)*
26 working days
* Firm has 5 HPLC systems which is used to test all products manufactured either as formulation in
one DML or as semi basic products in other DML. Under the semi-basic facility the firm also
manufacture pellets including sustained release, delayed release and dual delayed release pellets etc
which requires extensive testing and dissolution studies. Further the formulation side also contain
various sections which also requires product testing through HPLC.

Keeping in view the above, the panel members were of the opinion that the two sections i.e. Sterile
Dry Powder Injection Vial (General) and Sterile Dry Powder Injection Vial (Steroid) will have at
least 25% testing load of the whole Quality Control Laboratory. So keeping in view this factor the
total HPLC capacity was reduced to 25% to check the testing capacity for these two sections.
Average testing Capacity

Raw material Stability Total
Quarter capacity / Product tests utilized
tests tests tests
Quarter (%)
I (1st Jan – 31st

253 8 48 6 62 24.50 %
Mar 2021)
II (1st Apr – 30th
253 12 60 8 80 31.60 %
June 2021)
III (1st July – 30th
253 15 40 10 65 25.69 %
Sept 2021)
IV (1st Oct – 31st
253 10 54 8 72 28.45 %
Dec 2021)
Average capacity 27.56 %
HPLC Testing Capacity Utilized (average): 27.56 %

HPLC Testing Capacity Available (average): 72.44 %
Sterility testing capacity of the firm was also reduced to 25% of the total capacity for calculating
the overall capacity for these two sections.
Sterility Testing Capacity Calculation Quarter Wise (Average 12 tests/day)

Average capacity/ Test Capacity
Quarter
Quarter Performed Utilized %
I (1st Jan – 31st Mar
234 62 26.49%
2021)
II (1st Apr – 30th June
234 80 34.18%
2021)
III (1st July – 30th Sept
234 65 27.77%
2021)
IV (1st Oct – 31st Dec
234 72 30.76%
2021)
Average capacity available: 29.8%
Sterility Testing Capacity Utilized (average): 29.8%

Sterility Testing Capacity Available (average): 70.2%
Sterility testing capacity of the firm was also reduced to 25% of the total capacity for calculating
the overall capacity for these two sections.
Bacterial Endotoxin Test Capacity Calculation Quarter Wise (Average 200 tests / day)
Average capacity/ Test Capacity
Quarter
Quarter Performed Utilized %
I (1st Jan – 31st Mar
3900 158 4.05%
2021)
II (1st Apr – 30th June
3900 200 5.12%
2021)

III (1st July – 30th Sept
3900 145 3.71%
2021)
IV (1 Oct – 31st Dec
st
3900 188 4.82%
2021)
Average capacity available: 4.42%
BET Testing Capacity Utilized (average): 4.42 %

BET Testing Capacity Available (average): 95.57 %
Hot and Cold Incubator Testing Capacity

The testing capacity of hot and cold incubators was determined at maximum production load during
the study period i.e. January – December 2021.
INCUBATOR
TOTAL 08 INCUBATOR
Incubator Use capacity at a Media used for Capacity Capacity

Name time for testing utilized Available
incubation (Maximum (%) (%)
production load)
Test
Hot incubator for sterility 175 bottles for 07 test per day 4% 96 %
for sterility 14 days
Cool incubator for sterility 175 bottles for 07 test per day 4% 96 %
for sterility 14 days
Cool incubator For Bio 150 plates for 5 03 test per day 2% 98 %
for media plates burden test days
Hot incubator For area 270 plates for 3 80 plates per day 29.6 % 70.4 %
for media plates monitoring days
Hot incubator For Bio 288 plates for 3 80 plates per day 27.7 % 72.3 %
for incubation burden/ days
area
monitoring
Hot incubator For 300 tubes for 2 20 tubes per day 6.6 % 93.4 %
for biological biological days
indicators indicators
Hot incubator BET 216 for 1 hour 30 test per day 15 % 85 %
for BET
Dry heat Sterilization 360 plates per 80 plates per day 22.2 % 77.8 %
sterilizer day
Observations by the Inspection Panel:
• The panel observed that the firm has two separate Drug Manufacturing License i.e. DML by
way of formulation and DML by way of semi-basic manufacturing, however the firm has a
single QC laboratory which caters for all stages of testing for all type of products manufactured
in both licensed facilities.
• At the time of receiving of drug substance (containing multiple containers of sterile drug
substances) the firm perform complete analysis including physical, chemical and
microbiological tests using the sample vial / pouch provided with the containers.
• However, before production of commercial batches, the firm only performs BET test for the
drug substance instead of performing complete testing for each container.
• The representatives of the firm informed the panel that incase of non-pharmacopoeial drug
products, they were using UV methods for analysis, however they have switched all such
products to HPLC method / innovator’s specifications.
• During review of specifications of drug substance and drug product it was observed that the firm

has mentioned an alternate method (UV method) for assay testing in some cases. Upon
clarification the firm’s representatives informed that they use this alternate method only for
identification test of those drug substances which are already manufactured and released within
their own facility having DML by way of semi-basic manufacturing.
• It was also observed that the firm was using diluents for reconstitution of the drug products other
than those recommended by innovator product in certain cases like esomeprazole powder for
solution for injection/infusion etc.
CONCLUSION
The manufacturing capacity (installed, utilized and unutilized) and overall capacity of the analytical
equipment of M/s Vision Pharmaceuticals (Pvt.) Ltd Plot No. 22 – 23, Industrial Triangle Kahuta Road,
Islamabad, was assessed based on the data and record provided by the firm, interview of the personnel
and visit of the premises. The installed and utilized capacity of the manufacturing and analytical
equipment used for testing of products has been given in detail above for record and further necessary
action.
Dr. Farhad Ullah Dr. Muhammad Haseeb Tariq,

Assistant Director, PEC, PE&R Division Assistant Director, PEC, PE&R Division
DRAP, Islamabad DRAP, Islamabad
ANNEXURES:
Annexure 1 • Total number of registered products of the firm,
• Total number registered product for each aforementioned section
• Existing registered products on contract manufactured by the firm in
aforementioned sections
Annexure 2 • List of all quality control equipment along with its testing capacity
• Total number of QC, IPQC and stability study tests performed in each
quarter
Annexure • List of qualified personnel working in production, Quality control and
3 Quality assurance department
Annexure 4 • List of production equipment along with capacity
Annexure 5 • List of all production batches of each product manufactured in each quarter
from January to December 2021.
Annexure 6 • Calibration certificate of dryer and autoclave.
Decision: Registration Board discussed the inspection report in details. Deliberations were made
on used and available manufacturing and quality control capacity keeping in view all registered
product and currently applied products. After thorough deliberation, the Board decided to allow
contract manufacturing from M/s Vision Pharmaceuticals (Pvt) Ltd Plot No. 22 – 23, Industrial
Triangle Kahuta Road, Islamabad for following sections:
• Sterile Dry Powder Injection Vial (General)
• Sterile Dry Powder Injection Vial (Steroid)

Agenda of Evaluator PEC-IV
Agenda of Evaluator PEC-IV
Case no. 01 Registration applications on Form 5F for local manufacturing of (Human)
drugs
a. New cases
259. Name, address of Applicant / M/s Islam Pharmaceuticals
Marketing Authorization Holder 7KM Pasrur Road Sialkot
Name, address of Manufacturing M/s Islam Pharmaceuticals
site. 7KM Pasrur Road Sialkot
☐ Importer
Dy. No. and date of submission Dy. No. 23834 dated: 31-08-2021
Details of fee submitted PKR 20,000/- dated: 08/03/2021
PKR 10,000/- dated: 11/05/2020
Montisim 5mg tablet
brand name
Strength / concentration of drug of Each chewable tablet contains:
Active Pharmaceutical ingredient Montelukast as sodium…….5mg
(API) per unit
Red colored, Round shaped, chewable tablet
drug
Leukotriene receptor antagonist
(API)
USP
specifications
The status in reference regulatory Montelukast 5mg chewable tablet, Accord
authorities Healthcare Limited, United Kingdom, MHRA
Approved.
For generic drugs (me-too status) Montiget 5mg chewable tablet, Getz Pharma (Pvt)
Ltd. Reg# 034837
GMP status of the Finished Copy of cGMP issued on 23-07-202 on the basis of
product manufacturer evaluation conducted on 09-07-2020
Name and address of API ZHEJIANG TIANYU PHARMCEUTICALS CO.,
manufacturer. LTD.
No. 15, Donghai 5th Avenue, Zhejiang Provincial
chemical and medical Raw Materials
Base Linhai Zone, Taizhou City.

Module III (Drug Substance) Official monograph of montelukast sodium is
present in USP. The firm as submitted detail of
tests for related substances (Sulfoxide impurity, Cis
Isomer, methylketone, methylstyrene and total
impurities), specifications, analytical procedures
and its verification, batch analysis and justification
substance
months
Batches: (201310301, 201310302, 201310303)
comparative dissolution profile against the brand leader that is Singulair 5mg tablet
Batch No# S018860 by Merck Sharp & Dohme
limited UK by performing quality tests
(Identification, Assay, Dissolution, Uniformity of
dosage form).
CDP has been performed against the same brand
that is Singulair 5mg tablet by Merck Sharp &
Dohme limited UK in Acid media (pH 1.0-1.2) &
Acetate buffer 4.5pH and Phosphate Buffer (pH
6.8). The values for f1 and f2 are in the acceptable
range.
validation/verification of product including accuracy, precision and specificity.
Manufacturer of API ZHEJIANG TIANYU PHARMCEUTICALS CO., LTD.

No. 15, Donghai 5th Avenue, Zhejiang Provincial chemical and
medical Raw Materials, Base Linhai Zone, Taizhou City.
API Lot No. 11001-181210
Description of Pack
system)
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No . ZJ20180033 issued
certificate of API manufacturer by China food and Drug Control administration
issued by concerned regulatory valid until 14.03.2023.
3. Documents for the procurement of Copy of form 3, form 7 and commercial invoice
API with approval from DRAP (in (Invoice# TY119146 Dated: 28-02-2019 with
case of import). received quantity i.e. 15 kg) of Montelukast Batch
No# 11001-181210 with attestation of DRAP
Lahore dated: 11-03-2019
supported by attested respective Submitted
data sheets etc.
software 21CFR & audit trail Submitted
temperature and humidity Submitted
S.N Section Shortcomings Reply
o Communicated
1. 1.1 Differential fee according Differential fee of Rs:10000/- deposit slip #
to as per notification 34803402245 dated: 11-05-2022 submitted
No.F.7-11/2012-

B&A/DRAP dated 13-07-
2012
2. 1.3.5. GMP inspection report/ Latest cGMP certificate submitted
GMP certificate of the
manufacturing unit issued
within the last three years
shall be submitted.
3. 1.5.15 – Submit Original Signed original commitments submitted.
1.5.20 Commitment
4. 2.3.R.1.1 Assay of Drug substance Assay result 94.24% is result of montelukast
mentioned is 94.24% on as is basis (the content of montelukast in
while in Certificate of montelukast sodium API), while the result
Analysis of Drug 99.39% in Certificate of analysis of Drug
substance Assay is substance under assay is result on dried
99.39%. Clarification is basis.
required.
5. 3.2.S.4.2 USP specify montelukast We used montelukast sodium as working
dicyclohexylamine as standard which was standardized against
reference standard in drug Montelukast dicyclohexylamine CRS
substance assay testing Lot#Y0001436 B#2. CoA of montelukast
while you have used dicyclohexylamine Reference standard is
montelukast sodium as given under section 3.2.P.6 Reference
reference standard. standard or materials and also attached
Clarification is required. (As the primary reference standards are
costly and have small quantities, reference
standards used in routine test of
batch/product analysis are made in-house
against primary reference standard. The in-
house reference standards are
working/secondary reference standards).
6. 3.2.P.5.2 • USP specify We used montelukast sodium as working

montelukast standard which was standardized against
dicyclohexylamine as Montelukast dicyclohexylamine CRS
reference standard in Lot#Y0001436 B#2. CoA of montelukast
drug product analytical dicyclohexylamine Reference standard is
given under section 3.2.P.6 Reference
testing method while
standard or materials and also attached
you have used
(As the primary reference standards are
montelukast sodium as costly and have small quantities, reference
working standard. standards used in routine test of
Clarification is batch/product analysis are made in-house
required. against primary reference standard. The in-
7. 3.2.P.8 • Reference of previous • NA
approval of • Real time stability data summary sheets
applications with are attached.
stability study data of • Compliance record of HPLC Software
the firm (if any). 21CFR and audit trail reports on product
• Compliance Record of testing are attached.
HPLC software 21CFR

& audit trail reports on • Record of digital data logger for
product testing. temperature and humidity monitoring of
• Record of Digital data stability chambers is attached.
logger for temperature • Import documents submitted.
and humidity
chambers (real time
and accelerated)
• Documents for the
procurement of API
with approval from
DRAP (in case of
import).
Decision: Registration Board deferred the case for Scientific justification for use of
montelukast sodium as working standard instead of montelukast dicyclohexylamine
specified by USP monograph.
☐ Importer
Dy. No. and date of submission Dy. No.23836 dated: 31-08-2021
Details of fee submitted PKR 20,000/- dated: 22-02-2021
PKR 10,000/- dated: 11/05/2020
Montisim 10mg tablet
brand name
Active Pharmaceutical ingredient Montelukast as sodium…….10mg
(API) per unit
Yellow colored, Round shaped, film coated tablet
drug
Leukotriene receptor antagonist
(API)
USP
specifications
The status in reference regulatory Montelukast 10mg tablet, Accord Healthcare
authorities Limited, United Kingdom, MHRA Approved.

For generic drugs (me-too status) Montiget 10mg tablet, Getz Pharma (Pvt) Ltd. Reg#
034838
Name and address of API ZHEJIANG TIANYU PHARMCEUTICALS CO.,
manufacturer. LTD.
No. 15, Donghai 5th Avenue, Zhejiang Provincial
chemical and medical Raw Materials
Base Linhai Zone, Taizhou City.
Module III (Drug Substance) Official monograph of montelukast sodium is
tests for related substances (Sulfoxide impurity, Cis
Isomer, methylketone, methylstyrene and total
substance
months
Batches: (201310301, 201310302, 201310303)
comparative dissolution profile against the brand leader that is Singulair 10mg
tablet Batch No# S032494 by Merk Sharp & Dohme
limited UK by performing quality tests
dosage form).
that is Singulair 10mg tablet by Merk Sharp &

Dohme limited UK in Acid media (pH 1.0-1.2) &
Acetate buffer 4.5pH and Phosphate Buffer (pH
range.
Manufacturer of API ZHEJIANG TIANYU PHARMCEUTICALS CO., LTD.
No. 15, Donghai 5th Avenue, Zhejiang Provincial chemical and
medical Raw Materials, Base Linhai Zone, Taizhou City.
API Lot No. 11001-181210
Description of Pack
system)
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No . ZJ20180033 issued
certificate of API manufacturer by China food and Drug Control administration
issued by concerned regulatory valid until 14.03.2023.
3. Documents for the procurement of Copy of form 3, form 7 and commercial invoice
API with approval from DRAP (in (Invoice# TY119146 Dated: 28-02-2019 with
case of import). received quantity i.e. 15 kg) of Montelukast Batch
No# 11001-181210 with attestation of DRAP
Lahore dated: 11-03-2019
data sheets etc.

o Communicated
1. 1.1 Differential fee according Differential fee of Rs:10000/- deposit slip #
to as per notification 34803402245 dated: 11-05-2022 submitted
No.F.7-11/2012-
B&A/DRAP dated 13-07-
2012
2. 1.3.5. GMP inspection report/ Latest cGMP certificate submitted
GMP certificate of the
manufacturing unit issued
within the last three years
shall be submitted.
3. 1.5.15 – Submit Original Signed original commitments submitted.
1.5.20 Commitment
4. 2.3.R.1.1 Assay of Drug substance Assay result 94.24% is result of montelukast
mentioned is 94.24% on as is basis (the content of montelukast in
while in Certificate of montelukast sodium API), while the result
Analysis of Drug 99.39% in Certificate of analysis of Drug
substance Assay is substance under assay is result on dried
99.39%. Clarification is basis.
required.
5. 3.2.S.4.2 USP specify montelukast We used montelukast sodium as working
dicyclohexylamine as standard which was standardized against
reference standard in drug Montelukast dicyclohexylamine CRS
substance assay testing Lot#Y0001436 B#2. CoA of montelukast
while you have used dicyclohexylamine Reference standard is
montelukast sodium as given under section 3.2.P.6 Reference
reference standard. standard or materials and also attached
Clarification is required. (As the primary reference standards are
costly and have small quantities, reference
standards used in routine test of
batch/product analysis are made in-house
against primary reference standard. The in-
6. 3.2.P.5.2 • USP specify We used montelukast sodium as working
montelukast standard which was standardized against
dicyclohexylamine as Montelukast dicyclohexylamine CRS
reference standard in Lot#Y0001436 B#2. CoA of montelukast
drug product analytical dicyclohexylamine Reference standard is
given under section 3.2.P.6 Reference
testing method while
standard or materials and also attached
you have used
(As the primary reference standards are
montelukast sodium as costly and have small quantities, reference
working standard. standards used in routine test of
Clarification is batch/product analysis are made in-house
required. against primary reference standard. The in-
7. 3.2.P.8 • Reference of previous • NA
approval of

applications with • Real time stability data summary sheets
stability study data of are attached.
the firm (if any). • Compliance record of HPLC Software
• Submit real time 21CFR and audit trail reports on product
• stability summary testing are attached.
sheets for Compliance • Record of digital data logger for
Record of HPLC temperature and humidity monitoring of
software 21CFR & stability chambers is attached.
audit trail reports on • Import documents submitted.
product testing.
• Record of Digital data
logger for temperature
and humidity
chambers (real time
and accelerated)
procurement of API
with approval from
DRAP (in case of
import).
Decision: Registration Board deferred the case for Scientific justification for use of
montelukast sodium as working standard instead of montelukast dicyclohexylamine
specified by USP monograph.
Marketing Authorization Holder 29-30 Sectors 27, Korangi Industrial Area, Karachi.
Name, address of Manufacturing M/s Getz Pharma (Pvt.) Limited
site. 29-30 Sectors 27, Korangi Industrial Area, Karachi.
☐ Importer
Dy. No. and date of submission Dy. No.24703 dated 07/09/2021
Details of fee submitted PKR 30,000/-: Deposit slip # 8066123845
Diampa M XR 5mg + 1000mg tablet
brand name
Strength / concentration of drug of Each extended-release tablet contains:
Active Pharmaceutical ingredient Empagliflozin…..5mg
(API) per unit Metformin HCl USP…..1000mg
Pharmaceutical form of applied Light yellow colored oblong shaped biconvex, film
drug coated tablet plain on both sides.
Pharmacotherapeutic Group of Combination of oral blood glucose lowering
(API) drugs(Anti-diabetic)

Getz Pharma Specs.
specifications
Proposed Pack size 14’s (2×7’s) & 28’s (4×7’s)
Proposed unit price Rs. 982/- (14’s)
Rs. 1964/- (28’s)
The status in reference regulatory Synjardy XR 5mg + 1g tablet by M/s Boehringer
authorities Ingelheim, USA. USFDA Approved.
For generic drugs (me-too status) Erli Plus XR 5mg + 1000mg Tablet by M/s
PharmEvo (Pvt.) Ltd., Karachi. (Reg. No. 105273)
GMP status of the Finished Last GMP Inspection dated 03-12-2021 concludes
product manufacturer that M/s Getz Pharma Pvt. Ltd. is considered to be
operating at an acceptable level of compliance of
GMP requirements. Tablet (General & General
Antibiotic) section approved.
Name and address of API Empagliflozin:
manufacturer. Jiangsu Yongan Pharmaceutical Co., Ltd.
No. 18,237 provincial highway, Jiangsu Huai'an
Economic Development, China.
Metformin HCl:
Shouguang Fukang Pharmaceutical Co., Ltd.
North-East of Dongwaihuan Road, Dongcheng
Industrial Area, Shouguang, Shandong, China.
Module III (Drug Substance) Empagliflozin:
Official monograph of Empagliflozin is not present
in any pharmacopeia. The firm has submitted detail
of nomenclature, structure, general properties,
tests for impurities, specifications, analytical
drug substance
Metformin HCl:
Official monograph of Metformin HCl is present in
USP. The firm has submitted detail of
tests for impurities & related substances,

Empagliflozin:
months
Batches: (130701, 130702, 130801)
Metformin HCl:
months
Batches: (A-72611405016, A-72611405017, A-
72611405018)
its validation studies, batch analysis and
drug product.
comparative dissolution profile against the brand leader that is ErliPlus XR 5mg +
1000mg Tablet by M/s PharmEvo (Pvt.) Ltd. by
performing quality tests (Appearance, Average
Weight, Assay, Dissolution).
that is ErliPlus XR 5mg + 1000mg Tablet by M/s
PharmEvo (Pvt.) Ltd., in Acidic media (pH 1.2),
Acetate Buffer (pH 4.5) & Phosphate Buffer (pH
6.8). The f2 values are in the acceptable range.
Analytical method Method Validation studies have submitted
specificity.
Manufacturer of API Empagliflozin:Jiangsu Yongan Pharmaceutical Co., Ltd.
Development, China.
Metformin HCl: Shouguang Fukang Pharmaceutical Co., Ltd.
North-East of Dongwaihuan Road, Dongcheng Industrial Area,
Shouguang, Shandong, China.
API Lot No. Empagliflozin: 20191130 (0000171936)
Metformin HCl: A-32611910002 (0000173980) & A-81412001039
(0000176216)
Description of Pack
(Container closure Alu-Alu blister packed in unit carton (14’s & 28’s)
system)

Batch No. 532DS01 532DS02 532DS03
Manufacturing Date 25.06.2020 05.08.2020 05.08.2020
Date of Initiation 25.09.2020 09.10.2020 25.09.2020
No. of Batches 03
applications with stability study product for Mirab (Mirabegron) Extended Release
data of the firm (if any) Tablets 25mg & 50mg on 12th December, 2017.
Further, the said panel inspection report was
discussed in 277th Drug Registration Board meeting
held on 27th – 29th December 2017. The case was
approved and the inspection report confirms
following points:
2. Approval of API/ DML/GMP Empagliflozin: Copy of Drug Manufacturing
certificate of API manufacturer License no. Su 20160324 issued by Jiangsu Drug
issued by concerned regulatory Administration (Huai'an Inspection Branch) valid
authority of country of origin. till 06-12-2025.
Metformin HCl: Copy of GMP Certificate No.

SD20190888 issued by CFDA, China valid till 12-
03-2024.
3. Documents for the procurement of Empagliflozin: Firm has submitted copy of
API with approval from DRAP (in invoice (invoice# JXCAVIR-20191003AP) dated :
case of import). 03-01-2020 cleared by DRAP Karachi office dated
07.01-2020 specifying import 20Kg Empagliflozin:
(Batch# 20191130).
Metformin HCl: Firm has submitted copy of invoice
(invoice# JC202002009-1) dated : 18-03-2020
cleared by DRAP Karachi office dated 07.04.2020
specifying import of Metformin Hcl (Batch# A-
81412001039).
Firm has submitted copy of invoice (invoice#
JC201910012-2) dated : 30-12-2019 cleared by
DRAP Karachi office dated 07.01-2020 specifying
import of Metformin HCl (Batch# A-32611910002).

with batch manufacturing record, analytical record
and attested documents like chromatograms, Raw
data sheets, COA, summary data sheets etc.
data sheets etc.
Remarks OF Evaluator: Gap bew mfg and stability start
o Communicated
1. 1.5.2. Strength of Active Firm submitted Label claim as follows:
ingredient shall be stated
clearly. For example, each Each extended-release tablet contains:
tablet contains, Empagliflozin…..5mg
Metformin HCl USP…..1000mg
2. 2.3.R.1.1 In BMR of batch # Batch no # 0000176216 of Metformin HCl is
532DS03 batch no of drug used in manufacturing of 532DS03 and
substance Metformin HCl accordingly revised corrected stability
# 0000176216 while in summary sheets are submitted.
stability summary sheets it
is mentioned as batch #
000013980. Clarify which
batch of drug substance is
used in manufacturing of
532DS03.
3. 1.6.5 Valid Drug Manufacturing Valid Drug Manufacturing License of
License issued by the Empagliflozin issued by Jiangsu Drug
relevant regulatory Administration, China valid till 06.12.2025.
authority of country of
origin. Or Valid Good
Manufacturing Practice
(GMP) certificate of the
Drug Substance
manufacturer issued by
relevant regulatory
origin for Empagliflozin
4. 3.2.S.4.3 Method Verification Firm has submitted Analytical method
studies including verification studies, without performance of
specificity, accuracy and accuracy parameter. Firm has submitted
repeatability (method following justification:
precision) performed by “This is to bring to your kind attention that
the Drug Product we have used 100% API without any placebo
manufacturer for both drug in Analytical Method Verification Studies of
substance(s) Empagliflozin and Metformin HCl,
Empagliflozin & therefore, requirement of accuracy is not
Metformin HCl) Shall be applicable. Further, we have performed
submitted. linearity to check area response of the
sample as the concentration of the sample

raised within working range of sample i.e.,
50% - 150%.”
5. 3.2.P.2.2. CDP has been performed Comparative dissolution profile (CDP) with
1 with different strength. Erliplus XR Tablets 5mg + 1000mg (Batch
Clarification is required. No # 1B133) manufactured by Pharmevo
(Pvt) Limited, submitted.
6. 3.2.P.5.1 In specification of Updated finished product specifications
dissolution testing time submitted.
for Empagliflozin Q is not
mentioned
7. 3.2.P.8 Documents for the Documents for the procurement of
procurement of Metformin Metformin HCl for batch # (Batch# A-
HCl for batch # (Batch# 81412001039). with approval from DRAP
A-81412001039). with submitted.
approval from DRAP
Decision: Approved with innovator’s specification..
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
☐ Importer
brand name
Pharmaceutical form of applied Pink colored oblong shaped biconvex, film coated
drug tablet plain on both sides.
Anti-diabetic
(API)
Getz Pharma Specs.
specifications

Rs. 2137/- (28’s)
PharmEvo (Pvt.) Ltd., Karachi.
(Reg. No. 105274)
Metformin HCl:
drug substance
Metformin HCl:

Empagliflozin:
months
Batches: (130701, 130702, 130801)
Metformin HCl:
months
Batches: (A-72611405016, A-72611405017, A-
72611405018)
drug product.
6.8). The values for f2 are in the acceptable range.
specificity.
Manufacturer of API Empagliflozin: Jiangsu Yongan Pharmaceutical Co., Ltd.
Development, China.
API Lot No. Empagliflozin: 20191205 ( 0000174101)
Metformin HCl: A-22612002008 (0000177796) A-81412001039
(0000176216)
Description of Pack
system)

Batch No. 536DS01 536DS02 536DS03
No. of Batches 03
following points:

03-2024.
3. Documents for the procurement of Empagliflozin: Firm has submitted copy of
API with approval from DRAP (in invoice (invoice# JXCAVIR-200212) dated : 02-
case of import). 03-2020 cleared by DRAP Karachi office dated
(Batch# 20191205).
Metformin HCl: Firm has submitted copy of form 7
and invoice (invoice# JC202002010-1) dated : 09-
04-2020 cleared by DRAP Karachi office dated
22.04.2020 specifying import 9 of Metformin HCl
(Batch# A-22612002008).
DRAP Karachi office dated 07.04.2020 specifying

data sheets etc.
o Communicated
1. 1.5.2. Strength of Active Firm submitted Label as follows:
2. 2.3.R.1.1 In BMR of batch # 0000176216 of Metformin HCl is used in
536DS01 batch no of drug manufacturing of 536DS01 and accordingly
substance Metformin HCl revised corrected stability summary sheets
# 0000176216 mentioned are submitted.
while in stability summary
sheets it is mentioned as
batch # (0000177796).
Clarify which batch of
drug substance is used in
manufacturing of
536DS01.
Drug Substance
relevant regulatory

50% - 150%.”
5. 3.2.S.4.4 Submit Certificate of Certificate of analysis of Empagliflozin batch
analysis for Empagliflozin # (20191205) by drug substance manufacturer
batch #( 20191205) by and drug product manufacturer is attached.
drug substance
manufacturer and drug
1 with different strength. Erliplus XR Tablets 10mg + 1000mg (Batch
Clarification is required. No # 1D0683) manufactured by Pharmevo
(Pvt) Limited, submitted
mentioned
8. 3.2.P.8 • Documents for the Documents for the procurement of
procurement of Empagliflozin for batch # (0000174101) and
Empagliflozin for Metformin HCI for batch # (Batch# A-
batch #( 0000174101) 81412001039) with approval from DRAP are
with approval from attached.
DRAP.
procurement of
Metformin HCl for
batch # ( A-
81412001039 ) with
approval from DRAP
Decision: Approved with innovator’s specification.
2021.
☐ Importer

Diampa M XR 12.5mg + 1000mg tablet
brand name
Active Pharmaceutical ingredient Empagliflozin…..12.5mg
Pharmaceutical form of applied Red colored oblong shaped biconvex, film-coated
drug tablet plain on both sides.
Anti-diabetic
(API)
Getz Pharma Specs.
specifications
Rs. 2278/- (28’s)
The status in reference regulatory Synjardy XR 12.5mg + 1g tablet by M/s Boehringer
For generic drugs (me-too status) Erli Plus XR 12.5mg + 1000mg Tablet by M/s
(Reg. No. 105275)
Metformin HCl:

drug substance
Metformin HCl:
Empagliflozin:
months
Batches: (130701, 130702, 130801)
Metformin HCl:
months
Batches: (A-72611405016, A-72611405017, A-
72611405018)
drug product.
comparative dissolution profile against the brand leader that is ErliPlus XR 12.5mg
+ 1000mg Tablet by M/s PharmEvo (Pvt.) Ltd. by
that is ErliPlus XR 12.5mg + 1000mg Tablet by M/s
6.8). The values for f2 are in the acceptable range.
specificity.

Development, China.
API Lot No. Empagliflozin: 20191205 (0000174101), 20191130 (0000171936),
20190322 (0000161733)
Metformin HCl: A-81412001039 (0000176216), A-22612002008
(0000177796)
Description of Pack
system)
Batch No. 537DS02 537DS04 537DS06
No. of Batches 03
following points:

03-2024.

3. Documents for the procurement of Empagliflozin: Firm has submitted copy of form 7
API with approval from DRAP (in and invoice (invoice# JXCAVIR-200212) dated :
(Batch# 20191205).
Firm has submitted copy of form 7 and invoice
(invoice# CAVIR-20190303AP) dated : 28-03-
2019 cleared by DRAP Karachi office dated 05.04-
2019 specifying import 10Kg Empagliflozin:
(Batch# 20190322).
JXCAVIR-20191003AP) dated : 03-01-2020
cleared by DRAP Karachi office dated 07.01-2020
specifying import 20Kg Empagliflozin: (Batch#
20191130).

(invoice# JC202002010-1) dated : 09-04-2020
specifying import 9 of Metformin HCl (Batch# A-
22612002008).
data sheets etc.
o Communicated
tablet contains, Empagliflozin…..12.5mg
Drug Substance

relevant regulatory
50% - 150%.”
analysis for Empagliflozin # ((20191205 & 0000161733) by drug
batch # (20191205 & substance manufacturer and drug product
0000161733) by drug manufacturer are attached.
substance manufacturer
and drug product
manufacturer.
1 with different strength. Erliplus XR Tablets 12.5mg + 1000mg
Clarification is required. (Batch No # 1D062) manufactured by
Pharmevo (Pvt) Limited, submitted
6. 3.2.P.5.1 In specification iof Updated finished product specifications
mentioned
procurement of Empagliflozin for batch # (0000174101 and
Empagliflozin for 0000161733) and Metformin HCI for batch #
batch ( 0000174101 (Batch# A-81412001039 and B# A-
and 0000161733) with 22612002008) with approval from DRAP are
approval from DRAP. attached.
procurement of
Metformin HCl for
batch # ( A-
81412001039 and A-
22612002008) with
approval from DRAP
2021.

☐ Importer
brand name
Pharmaceutical form of applied Yellow colored, oblong shaped, biconvex film
drug coated tablet, plain on both sides.
Anti-diabetic
(API)
Getz Pharma Specs.
specifications
Proposed Pack size 14’s (2×7’s)
(Reg. No. 105276)
Metformin HCl:

drug substance
Metformin HCl:
Empagliflozin:
months
Batches: (130701, 130702, 130801)
Metformin HCl:
months
Batches: (A-72611405016, A-72611405017, A-
72611405018)
drug product.

6.8). The f2 values are in the acceptable range..
specificity.
Development, China.
API Lot No. Empagliflozin: 20191205 (0000174101), 20190322 (0000161733)
Metformin HCl: A-32611910002 (0000173980), A-81412001039

(0000176216)
Description of Pack
system)
Batch No. 533DS02 533DS03 533DS05
No. of Batches 03
following points:

•
Adequate monitoring and control are available

03-2024.
3. Documents for the procurement of Empagliflozin: Firm has submitted copy of form 7
API with approval from DRAP (in and invoice (invoice# JXCAVIR-200212) dated :
(Batch# 20191205).
Firm has submitted copy of form 7 and invoice
(invoice# CAVIR-20190303AP) dated : 28-03-2019
cleared by DRAP Karachi office dated 05.04-2019
specifying import 10Kg Empagliflozin: (Batch#
20190322).
(invoice# JC201910012-2) dated : 30-12-2019
specifying import 9 of Metformin HCl (Batch# A-
32611910002 ).
import of Metformin HCl (Batch# A-
81412001039).
data sheets etc.
o Communicated

2. 2.3.R.1.1 In BMR of batch # Batch no: 0000174101 of Empagliflozin and
533DS05 batch no of drug Batch no: 0000176216 of Metformin HCl is
substance Empagliflozin # used in manufacturing of 533DS05 and
0000174101 and accordingly revised corrected stability
Metformin HCl# summary sheets are submitted.
0000176216 mentioned
while in stability summary
sheets it is mentioned as
batch Empagliflozin #
0000171936 and
Metformin HCl
#0000177796. Clarify
which batch of drug
substance’s are used in
manufacturing of
533DS05.
Drug Substance
relevant regulatory
50% - 150%.”
analysis for Empagliflozin # ((20191205 & 0000161733) by drug
batch # (20191205 & substance manufacturer and drug product
0000161733) by drug manufacturer are attached.
substance manufacturer
and drug product
manufacturer.
mentioned

procurement of Empagliflozin for batch # (0000174101 and
Empagliflozin for 0000161733) and Metformin HCI for batch #
batch # (0000174101 (Batch# A-81412001039) with approval
and 0000161733) with from DRAP. Are attached.
approval from DRAP.
procurement of
Metformin HCl for
batch # ( A-
81412001039 ) with
approval from DRAP
2021.
265. Name, address of Applicant / "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14,
Marketing Authorization Holder Sector-15, Korangi, Industrial Area, Karachi.”
Name, address of Manufacturing "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14,
site. Sector 15, Korangi, Industrial Area, Karachi.”
☐ Importer
Dy. No. and date of submission Dy. No.23218 Dated: 25-08-2021
Details of fee submitted PKR 30,000/- Dated: 16-06-2021
Racehil Granules for suspension 10mg
brand name
Strength / concentration of drug of Each Sachet Contains:
Active Pharmaceutical ingredient Racecadotril ………………… 10mg
(API) per unit
Granules for suspension
drug
Antidiarrheal
(API)
Innovator
specifications

Hidrasec® 10mg by France Approved.
authorities
For generic drugs (me-too status) “Hidrasec® 10mg” Sachet by M/s Abbott
Laboratories Reg# 087082
GMP status of the Finished Section for Capsule (General) was granted after
product manufacturer renewal of Drug Manufacturing Licence inspection
vide letter No. F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Name and address of API Racecadotril:
manufacturer. M/s SVK Laboratories Private Limited
D-16, Phase-I, IDA-Jeedimetla Hyderabad-500055
Telangana State-India.
Module III (Drug Substance) Firm has submitted detailed drug substance data on
CTD format related to nomenclature, structure,
process and controls, impurities, specifications and
analytical procedures, batch analysis and
drug substance.
months
Racecadotril:
Batches #: (RCL/00415, RCL/00515, RCL/00615)
Module-III (Drug Product): Firm has submitted data of drug product including
development, manufacturing process and process
control, control of excipients, control of drug
comparative dissolution profile against the Hidrasec® Granules for suspension
10mg manufactured by Sophatrex 21 Rue du
pressoir , France for Abbott Laboratories
The firm has submitted the comparative dissolution
with Hidrasec® Granules for suspension 10mg
manufactured by Sophatrex 21 Rue du pressoir ,

France for Abbott Laboratories. and dissolution
profile in Acid media (pH- 1.2) Acetate Buffer (pH-
4.5) & Phosphate Buffer (pH 6.8). The values for f1
and f2 are in the acceptable range.
validation/verification of product including, Specificity, linearity, range, accuracy,
Precision Repeatability, Intermediate precision,
Robustness, System Suitability.
Manufacturer of API M/s SVK Laboratories Private Limited
D-16, Phase-I, IDA-Jeedimetla Hyderabad-500055 Telangana State-
India.
API Lot No. RCL/0050919
Description of Pack
(Container closure Alu-Alu paper foil
system)
Batch No. RAC-419105-4 RAC-419105-5 RAC-419105-6
Batch Size 1000 Sachet 1000 Sachet 1000 Sachet
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No (39250/TS/2020)
certificate of API manufacturer issued by Drugs control administration Telangana
issued by concerned regulatory (DCA) valid until 26.05.2021.
3. Documents for the procurement of Copy commercial invoice (Invoice# EXP/2019-
API with approval from DRAP (in 20/010 Dated: 05-12-2019 with received quantity
case of import). i.e. 2 kg) of Racecadotril Batch No# RCL/0050919
with attestation of DRAP Karachi dated: 16-12-
2019
data sheets etc.
5. Compliance Record of HPLC We have maintained manual logs of all tests.

o Communicated
1. 2.3.R.1.1 In BMR potency of Drug In BMR potency of Drug Substance on As is
substance mentioned on basis was taken 100.96% for trial batches.
As is basis is 100.96% The actual potency of API was 99.49%. In
while in COA 99.49% . fact 100.96% potency was erroneously taken
Clarification is required. from 20.0g docket sample of API received
for initial testing purpose. Please find
enclosed data of docket sample including
with raw data as your ready reference.
However, both docket sample for initial
testing and API received for trial batches
have potency results within the specification
limit i.e. 98 – 102% (on dried basis). The
difference is minor and that is 1.47%, which
does not effect stability data as all assay
results are well within limits.
“In continuation of our letter no. SA/MI/05-

22/78 (Racehil Granules for Suspension)
submitted on 12.05.2022. As required, we
explain the point No. 2.3.R.1.1, vendor
sample from manufacturer for
testing/evaluation purpose is termed as
docket sample. Potency of docket sample
was used mistakenly instead of potency of
API. However, there is no significant
difference in potency of docket sample &
API used for trial batches”
2. 3.2.P.2.2.
Pharmaceutical All quality tests (mentioned in section
1 equivalence of the applied 3.2.P.5.1) were tested for test product
drug shall be established (Racehil Granules for Oral Suspension
with the innovator / 30mg) and innovator (Hidrasec Granules For
reference / comparator Oral Suspension 30mg) and found to be
product and results of all satisfactory and comparable.
the quality tests
(mentioned in any official
pharmacopoeia or section
3.2.P.5.1 of this
application) of the
developed formulation and
the innovator / reference /
comparator product shall
be submitted and
discussed
9. 3.2.P.5.1 Dissolution testing not Dissolution test has been included in
included in specification. specification, enclosed.

2021.
266. Name, address of Applicant / "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14,
Marketing Authorization Holder Sector-15, Korangi, Industrial Area, Karachi.”
Name, address of Manufacturing "M/s Hilton Pharma (Pvt.) Ltd. Plot No. 13-14,
site. Sector 15, Korangi, Industrial Area, Karachi.”
☐ Importer
Dy. No. and date of submission Dy. No.23217 Dated: 25-08-2021
Details of fee submitted PKR 30,000/- Dated: 16-06-2021
Racehil Granules for suspension 30mg
brand name
Strength / concentration of drug of Each Sachet Contains:
Active Pharmaceutical ingredient Racecadotril ………………… 30mg
(API) per unit
Granules for suspension
drug
Antidiarrheal
(API)
Innovator
specifications
Hidrasec® 30mg by France Approved.
authorities
For generic drugs (me-too status) “Hidrasec® 30mg” Sachet by M/s Abbott
Laboratories Reg# 087517
GMP status of the Finished Section for Capsule (General) was granted after
product manufacturer renewal of Drug Manufacturing Licence inspection
vide letter No. F. 2-14/85-Lic (Vol-V)
Dated: 30/06/2020
Name and address of API M/s SVK Laboratories Private Limited
manufacturer. D-16, Phase-I, IDA-Jeedimetla Hyderabad-500055
Telangana State-India.

Module III (Drug Substance) Firm has submitted detailed drug substance data on
CTD format related to nomenclature, structure,
process and controls, impurities, specifications and
analytical procedures, batch analysis and
drug substance.
months
Racecadotril:
Batches #: (RCL/00415, RCL/00515, RCL/00615)
development, manufacturing process and process
control, control of excipients, control of drug
comparative dissolution profile against the Hidrasec® Granules for suspension
30mg manufactured by Sophatrex 21 Rue du
pressoir , France for Abbott Laboratories
The firm has submitted the comparative dissolution
with Hidrasec® Granules for suspension 30mg
manufactured by Sophatrex 21 Rue du pressoir ,
France for Abbott Laboratories. and dissolution
profile in Acid media (pH 1.2) Acetate Buffer (pH-
4.5) & Phosphate Buffer (pH- 6.8). The values for
f1 and f2 are in the acceptable range.
validation/verification of product including, Specificity, linearity, range, accuracy,
Precision Repeatability, Intermediate precision,
Robustness, System Suitability.
Manufacturer of API M/s SVK Laboratories Private Limited
D-16, Phase-I, IDA-Jeedimetla Hyderabad-500055 Telangana State-
India.

API Lot No. RCL/0050919
Description of Pack
(Container closure Alu-Alu paper foil
system)
Batch No. RAC-418604-6 RAC-418904-7 RAC-419004-8
Batch Size 500 Sachet 500 Sachet 500 Sachet
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No (39250/TS/2020)
certificate of API manufacturer issued by Drugs control administration Telangana
issued by concerned regulatory (DCA) valid until 26.05.2021.
3. Documents for the procurement of Copy commercial invoice (Invoice# EXP/2019-
API with approval from DRAP (in 20/010 Dated: 05-12-2019 with received quantity
case of import). i.e. 2 kg) of Racecadotril Batch No# RCL/0050919
with attestation of DRAP Karachi dated: 16-12-
2019
data sheets etc.
5. Compliance Record of HPLC We have maintained manual logs of all tests.
o Communicated
1. 2.3.R.1.1 In BMR potency of Drug In BMR potency of Drug Substance on As is
substance mentioned on basis was taken 100.96% for trial batches.
As is basis 100.96% while The actual potency of API was 99.49%. In
in COA 99.49% fact 100.96% potency was erroneously taken
from 20.0g docket sample of API received
for initial testing purpose. Please find
enclosed data of docket sample including

with raw data as your ready reference.
However, both docket sample for initial
testing and API received for trial batches
have potency results within the specification
limit i.e. 98 – 102% (on dried basis). The
difference is minor and that is 1.47%, which
does not effect stability data as all assay
results are well within limits.
“In continuation of our letter no. SA/MI/05-

22/78 (Racehil Granules for Suspension)
submitted on 12.05.2022. As required, we
explain the point No. 2.3.R.1.1, vendor
sample from manufacturer for
testing/evaluation purpose is termed as
docket sample. Potency of docket sample
was used mistakenly instead of potency of
API. However, there is no significant
difference in potency of docket sample &
API used for trial batches”
2. 3.2.P.2.2. Pharmaceutical All quality tests (mentioned in section
1 equivalence of the applied 3.2.P.5.1) were tested for test product
drug shall be established (Racehil Granules for Oral Suspension
with the innovator / 30mg) and innovator (Hidrasec Granules For
reference / comparator Oral Suspension 30mg) and found to be
product and results of all satisfactory and comparable
the quality tests
3.2.P.5.1 of this
application) of the
be submitted and
discussed
10. 3.2.P.5.1 Dissolution testing not Dissolution test has been included in
included in specification. specification, enclosed.
commitment submitted in the registration application.F
2021.
☐ Importer

Details of fee submitted PKR 30,000/- dated: 04/08/2021
Dentofin 100mg tablet
brand name
Active Pharmaceutical ingredient Flurbiprofen…….100mg
(API) per unit
Blue color, round, biconvex, film coated tablets
drug
Anti-inflammatory and anti-rheumatic (NSAID)
(API)
USP
specifications
The status in reference regulatory Flurbiprofen 100mg film coated tablet, Pharmacia
authorities and Upjohn, USFDA Approved.
For generic drugs (me-too status) ANSAID 100mg tablet, Pfizer Pakistan Limited
Reg# -12299
Name and address of API Hy-Gro Chemicals Pharmtek Private Limited, Plot
manufacturer. No. 174, Progressive Industrial Society,
IDA Bollaram, Jinnaram (Mandal), Sanga Reddy
(District), Telangana, INDIA
Module III (Drug Substance) Official monograph of flurbiprofen is present in
B.P. The firm as submitted detail of nomenclature,
process and controls, tests for related substances
(Impurity A, B, C, D, E, Unknown and total

substance
months

comparative dissolution profile against the Innovator that is ANSAID 100mg tablet
by Pfizer Pakistan Ltd by performing quality tests
(Identification, Assay, Disintegration, Dissolution,
Uniformity of dosage form).
that is ANSAID 100mg tablet by Pfizer Pakistan Ltd
in Acid media (pH 1.0-1.2) & Acetate buffer 4.5pH
and Phosphate Buffer (pH 6.8). The values for f1
Manufacturer of API Hy-Gro Chemicals Pharmtek Private Limited, Plot No. 174,
Progressive Industrial Society, IDA Bollaram, Jinnaram (Mandal),
Sanga Reddy (District), Telangana, INDIA.
API Lot No. FB-2020/07/41
Description of Pack
system)
No. of Batches 03

2. Approval of API/ DML/GMP Copy of GMP certificate No. L.Dis.
certificate of API manufacturer No.69129/Stores/2021 issued by Drug control
issued by concerned regulatory administration Government of Telangana issued on
authority of country of origin. 18-09-2021 and valid for a period of three years.
3. Documents for the procurement of Copy of letter No.12086/2020/DRAP-AD-G (I&E)
API with approval from DRAP (in dated 26/08/2020 is submitted wherein the
case of import). permission to import different APIs including
Flurbiprofen for the purpose of test/analysis and
Firm has submitted copy of Form 3, Form 7 &
invoice (invoice# HBD/EXP/84) Dated: 23-09-
2020 from Hy-Gro Chemicals Pharmtek Private
Limited specifying import 0.7096Kg Flurbiprofen
(Batch# FB-2020/07/41). But no approval by
DRAP.
data sheets etc.
o Communicated
1. 3.2.S.4.1 Drug substance We have changed specification from USP to
manufacturer BP, revised Standard analytical procedure,
specifications are BP for performed method verification studies as per
drug substance while drug BP and performed complete analysis of Drug
product manufacture substance as per BP method.
specifications are USP for Revised standard analytical procedure and
drug substance. specifications, method verification protocol
Clarification is required. and report and Drug substance analytical
record as per BP specification are attached.
• (However different batch no
mentioned on COA.)
2. 3.2.P.2.2. Pharmaceutical Pharmaceutical equivalence study report and
1 equivalence of the applied analytical record is attached
drug shall be established
with the innovator /
reference / comparator
product and results of all
the quality tests

3.2.P.5.1 of this
application) of the
be submitted and
discussed
3. 3.2.P.8 • Approval of API/ • GMP certificate of API manufacturer

DML/GMP certificate is attached.
of API manufacturer • For document for procurement of
issued by concerned API form 6 submitted (However of
regulatory authority of
different batch no mentioned.)
country of origin.
• Documents for the • Compliance record of HPLC software
procurement of API 21CFR & Audit trail reports on
with approval from product testing are attached.
DRAP (in case of • Record of digital data logger for
import). temperature and humidity monitoring
• Compliance Record of of stability chambers is attached .
HPLC software 21CFR
& audit trail reports on
product testing
• Record of Digital data
logger for temperature
and humidity
chambers (real time
and accelerated)
4. In continuation of previous reply firm submitted justification for change of Batch No
on COA and import documents as follows:
1. “Flurbiprofen Drug substance was received in Raw material store and RMS in-
Charge asked purchase department for CoA (as the soft copy of document is
received in purchase dept. and hard copy arrives after few days of receiving of
drug substance). Purchase department provided CoA of different Batch No.
(FBP-2020/09/24) (mistakenly provided by supplier to purchase department) to
RMS and the same Batch number was recorded in all documents in RMS,
quality control laboratory and production.
2. At the time of reply to deficiencies of Dentofin 100mg tablet above issue was
detected that the import documents have different batch number (FB-
2020/07/41) compared to our record. After investigation above mentioned
mistake was traced, correct batch number CoA provided and record was
corrected.
3. As it was observed in deficiencies (performance of test as per USP instead of
BP) we performed method verification studies as per drug substance
manufacturer specifications (BP) and retested the drug substance as per BP
method mentioning correct batch number. Method verification protocol, report,
revised SAP for drug substance, testing record and report submitted to your
office.
4. Flurbiprofen drug substance was initially tested by USP method (assay by
titration using indicator) on 16-Nov-2020 and Trial batches were manufactured

as per USP method results (99.45% on as is basis). Flurbiprofen drug substance
was re-tested as per manufacturer specifications by BP method (assay by
potentiometric titration) on 15-Jun-2022, assay result (99.16% on as is basis).
5. The difference of assay result is 0.30% which is due to difference of time
between two analysis/tests (1.7 years) and testing method (titration method
using indicator versus potentiometric titration).”
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in Drug
Substance, specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
268. Name, address of Applicant / M/s Scotmann Pharmaceuticals,
Marketing Authorization Holder 5-D, I-10/3, Industrial Area, Islamabad, Pakistan
Name, address of Manufacturing M/s Scotmann Pharmaceuticals,
site. 5-D, I-10/3, Industrial Area, Islamabad, Pakistan
☐ Importer
Tanavul Tablets 10mg
brand name
Strength / concentration of drug of Each film coated Tablet contains:
Active Pharmaceutical ingredient Vonoprazan Fumarate eq.to Vonoprazan….10mg
(API) per unit
Pharmaceutical form of applied Film coated tablets
drug
Potassium-competitive acid blocker
(API)
Manufacturer specification
specifications
Proposed Pack size 7’s, 10’s, 14’s, 20’s, 28’s & 30’s
Takecab 10mg Tablets (PMDA Japan Approved)
authorities
For generic drugs (me-too status) Voniza tablets 10mg Manufacture by Hilton Pharma
(Pvt.) Ltd. Reg # 108573

GMP status of the Finished cGMP certificate on the basis of inspection and
product manufacturer evaluation conducted on 09-11-2020 and valid till
08-11-2022
Name and address of API Name: Ami Lifesciences Pvt.Ltd.
manufacturer. Address: Block No. 82/B, Ecp Road, At & Post.
Karakhadi, Taluka-Padra, District Vadodara
Gujarta, India
Module III (Drug Substance) Official monograph of Vonoprazan Fumarate is not
present in any Pharmacopeia. The firm as submitted
process and controls, tests for impurity related
substances, specifications, analytical procedures
substance.
Long term: 30°C ± 2°C / 65% ± 5%RH for 18
months
months
drug product.
comparative dissolution profile against the brand leader that is Voniza Tablets 10mg
by Hilton Pharma (Pvt.) Ltd. performing quality
tests (Identification, D. time, Dissolution, Assay).
that is Voniza Tablets 10mg by Hilton Pharma
(Pvt.) Ltd, Dissolution profiles of both products
(Voniza Tablets 10mg and Tanavul Tablets 10mg)
were compared at three pH (1.2, 4.5, and 6.8)
graphically and statistically.

validation/verification of product including linearity, Robustness, accuracy, precision
(Repeatability), specificity.
Manufacturer of API Name: Ami Lifesciences Pvt.Ltd.
Address: Block No. 82/B, Ecp Road, At & Post. Karakhadi, Taluka-
Padra, District Vadodara Gujarta, India
API Lot No. VPF/RD/30720520
Description of Pack
Alu-Alu blister with cold aluminum foil (7’s, 10’s, 14’s, 20’s, 28’s &
(Container closure
30’s)
system)
Stability Storage Long term: 30°C ± 2°C / 65% ± 5%RH
Time Period Long term: 6 months
Frequency Accelerated: Initial, 3, 6 (Months)
Long term: Initial, 3, 6 (Months)
Batch No. T-01 T-02 T-03
No. of Batches 03
applications with stability study product “Dascot (Daclatasvir) 30mg Tablets” which
data of the firm (if any) was presented in 278th meeting of Registration
Board wherein the Board decided to approve
registration of this product
Date of inspection: 26th January, 2018.
According to inspection report, following points
were confirmed.
• The firm has 21CFR compliant HPLC software.

stability chamber
2. Approval of API/ DML/GMP Copy of GMP certificate No . 22043267 issued by

certificate of API manufacturer food and Drug Control administration Gandhinagar
issued by concerned regulatory Gujarat State India valid until 17.04.2025.
3. Documents for the procurement of Firm has submitted copy of Form 3,Form 6, Form
API with approval from DRAP (in 7 & invoice (invoice# EXP/1/20-21/0217) Dated:
case of import). 20-08-2020 from Ami life sciences Pvt. Ltd
cleared by DRAP Islamabad office dated 09-09-
2020 specifying import 300g Vonoprazone
Fumarate(Batch# VPF/RD/30720520).

data sheets etc.
o Communicated
1. 1.6.5 Name and address of API Good Manufacturing Practice (GMP)
manufacturer. certificate of the Drug Substance
Valid Drug Manufacturing manufacturer issued by relevant regulatory
License issued by the authority of country of origin is attached.
relevant regulatory
origin. ii. Valid Good
Drug Substance
relevant regulatory
origin.
2. 2.3.R.1.1 Provide copy of Batch Batch Manufacturing Record (BMR) for all
Manufacturing Record the batches of drug product for which
(BMR) for all the batches stability studies data is provided
of drug product for which
stability studies data is
provided in Module 3
section 3.2.P.8.3
3. 3.2.S.4.1 Copies of the Drug Copies of the Drug substance specifications
substance specifications by by Drug Product manufacturer is attached.
Drug Product
manufacturer is required
4. 3.2.S.4.2 Copies of the Drug Copies of the Drug substance analytical
substance analytical procedures used for routine testing of the
procedures used for Drug substance /Active Pharmaceutical
routine testing of the Drug Ingredient by Drug Product manufacturer is
substance /Active attached.
by Drug Product
5. 3.2.S.4.3 Analytical Method Analytical Method Verification studies
Verification studies including specificity, accuracy and
including specificity, repeatability (method precision) performed
accuracy and repeatability by the Drug Product manufacturer for drug
(method precision) substance is attached.
performed by the Drug

Product manufacturer for
drug substance(s) shall be
submitted.
6. 3.2.S.4.4 Certificate of Analysis Certificate of Analysis (CoA) of the same
(CoA) of the same batch batch
used during product used during product development and
development and stability stability studies from Drug Substance /
studies from Drug /Active Pharmaceutical Ingredient
Substance / /Active manufacture is submitted.
manufacture.
7. 3.2.P.2.2. Pharmaceutical The Innovator product was not readily
1 Equivalence and CDP not available in the market at the time of
performed with Innovator. performing these studies in Pakistan.
Clarification is required. Therefore, we selected a comparator product
that has been approved by DRAP and is the
most widely used brand in Pakistan.
8. 3.2.P.5.2 Justify the adaptation of Dissolution parameters i.e revolution
dissolution parameters (50rpm), dissolution media volume (900ml)
including type of and time (30 minutes) of Vonaprazan Tablet
apparatus, speed (rpm), 10mg and Vonaprazan Tablet 20mg were
dissolution medium, selected as per USP chapter <1092>.
volume and time keeping For the selection of dissolution media, the
in view the solubility and dose solubility ratio of Vonoprazan was
pKa of the drug substance, performed in pH 1.2, 4.5, and 6.8 buffer.
pH – pKa solubility profile Dose solubility ratio was very high
and recommendations throughout the physiological buffer range i.e.
from general chapters of 1mg/ml in pH 6.8 buffers, 10mg/ml in pH
official pharmacopoeia 1.2 buffers, and 10.4mg/ml in pH 4.5 buffers.
Therefore, we selected a dissolution medium
having 6.8 pH as a strict-case scenario.
<Reference Attached>
Dose solubility volume ratio was calculated
by using the following formula:
Dose solubility volume:
Dose (mg)
Solubility (mg/ml)
9. 3.2.P.8 Record of Digital data Record of Digital data logger for temperature
logger for temperature and and humidity monitoring of stability
humidity monitoring of chambers (real time and accelerated)
stability chambers (real submitted.
269. Name, address of Applicant / M/s Scotmann Pharmaceuticals,
Marketing Authorization Holder 5-D, I-10/3, Industrial Area, Islamabad, Pakistan
Name, address of Manufacturing M/s Scotmann Pharmaceuticals,
site. 5-D, I-10/3, Industrial Area, Islamabad, Pakistan

☐ Importer
Tanavul Tablets 20mg
brand name
Strength / concentration of drug of Each film coated Tablet contains:
Active Pharmaceutical ingredient Vonoprazan Fumarate eq.to Vonoprazan….20mg
(API) per unit
Pharmaceutical form of applied Film coated tablets
drug
Potassium-competitive acid blocker
(API)
Manufacturer specification
specifications
Takecab 20mg Tablets (PMDA Japan Approved)
authorities
For generic drugs (me-too status) Voniza tablets 20mg Manufacture by Hilton Pharma
(Pvt.) Ltd. Reg # 108572
GMP status of the Finished cGMP certificate on the basis of inspection and
product manufacturer evaluation conducted on 09-11-2020 and valid till
08-11-2022
Name and address of API Name: Ami Lifesciences Pvt.Ltd.
manufacturer. Address: Block No. 82/B, Ecp Road, At & Post.
Karakhadi, Taluka-Padra, District Vadodara
Gujarta, India
Module III (Drug Substance) Official monograph of Vonoprazan Fumarate is not
present in any Pharmacopeia. The firm as submitted

substance.
months
months
drug product.
comparative dissolution profile against the brand leader that is Voniza Tablets 20mg
by Hilton Pharma (Pvt.) Ltd. performing quality
tests (Identification, D. time, Dissolution, Assay).
that is Voniza Tablets 20mg by Hilton Pharma
(Pvt.) Ltd, Dissolution profiles of both products
(Voniza Tablets 10mg and Tanavul Tablets 10mg)
validation/verification of product including linearity, Robustness, accuracy, precision
(Repeatability), specificity.
Manufacturer of API Name: Ami Lifesciences Pvt.Ltd.
Address: Block No. 82/B, Ecp Road, At & Post. Karakhadi, Taluka-
Padra, District Vadodara Gujarta, India
API Lot No. VPF/RD/30720520
Description of Pack
Alu-Alu blister with cold aluminum foil (7’s, 10’s, 14’s, 20’s, 28’s &
(Container closure
30’s)
system)
Stability Storage Long term: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: Initial, 3, 6 (Months)

No. of Batches 03
applications with stability study product “Dascot (Daclatasvir) 30mg Tablets” which
data of the firm (if any) was presented in 278th meeting of Registration
Board wherein the Board decided to approve
registration of this product
Date of inspection: 26th January, 2018.
According to inspection report, following points
were confirmed.
• The firm has 21CFR compliant HPLC software.

stability chamber
2. Approval of API/ DML/GMP Copy of GMP certificate No . 19041306 issued by

certificate of API manufacturer food and Drug Control administration Gandhinagar
issued by concerned regulatory gujjarat State India valid until 24.04.2022.
3. Documents for the procurement of Firm has submitted copy of Form 3,Form 6, Form
API with approval from DRAP (in 7 & invoice (invoice# EXP/1/20-21/0217) Dated:
case of import). 20-08-2020 from Ami life sciences Pvt. Ltd
cleared by DRAP Islamabad office dated 09-09-
2020 specifying import 300g Vonoprazone
(Batch# VPF/RD/30720520).
data sheets etc.
o Communicated
1. 1.6.5 Name and address of API Good Manufacturing Practice (GMP)
manufacturer. certificate of the Drug Substance
Valid Drug Manufacturing manufacturer issued by relevant regulatory
License issued by the authority of country of origin is attached.
relevant regulatory
origin. ii. Valid Good
Drug Substance
relevant regulatory

origin.
Manufacturing Record the batches of drug product for which
(BMR) for all the batches stability studies data is provided
provided in Module 3
section 3.2.P.8.3
3. 3.2.S.4.1 Copies of the Drug Copies of the Drug substance specifications
substance specifications by by Drug Product manufacturer is attached.
Drug Product
4. 3.2.S.4.2 Copies of the Drug Copies of the Drug substance analytical
substance analytical procedures used for routine testing of the
procedures used for Drug substance /Active Pharmaceutical
routine testing of the Drug Ingredient by Drug Product manufacturer is
substance /Active attached.
by Drug Product
5. 3.2.S.4.3 Analytical Method Analytical Method Verification studies
Verification studies including specificity, accuracy and
including specificity, repeatability (method precision) performed
accuracy and repeatability by the Drug Product manufacturer for drug
(method precision) substance is attached.
Product manufacturer for
drug substance(s) shall be
submitted.
6. 3.2.S.4.4 Certificate of Analysis Certificate of Analysis (CoA) of the same
(CoA) of the same batch batch
used during product used during product development and
development and stability stability studies from Drug Substance /
studies from Drug /Active Pharmaceutical Ingredient
Substance / /Active manufacture is submitted.
manufacture.
7. 3.2.P.2.2. Pharmaceutical The Innovator product was not readily
1 Equivalence and CDP not available in the market at the time of
performed with Innovator. performing these studies in Pakistan.
Clarification is required. Therefore, we selected a comparator product
that has been approved by DRAP and is the
most widely used brand in Pakistan.
8. 3.2.P.5.2 Justify the adaptation of Dissolution parameters i.e revolution
dissolution parameters (50rpm), dissolution media volume (900ml)
including type of and time (30 minutes) of Vonaprazan Tablet
apparatus, speed (rpm),

dissolution medium, 10mg and Vonaprazan Tablet 20mg were
volume and time keeping selected as per USP chapter <1092>.
in view the solubility and For the selection of dissolution media, the
pKa of the drug substance, dose solubility ratio of Vonoprazan was
pH – pKa solubility profile performed in pH 1.2, 4.5, and 6.8 buffer.
and recommendations Dose solubility ratio was very high
from general chapters of throughout the physiological buffer range i.e.
official pharmacopoeia 1mg/ml in pH 6.8 buffers, 10mg/ml in pH
1.2 buffers, and 10.4mg/ml in pH 4.5 buffers.
Therefore, we selected a dissolution medium
having 6.8 pH as a strict-case scenario.
<Reference Attached>
Dose solubility volume ratio was calculated
by using the following formula:
Dose solubility volume:
Dose (mg)
Solubility (mg/ml)
9. 3.2.P.8 Record of Digital data Record of Digital data logger for temperature
logger for temperature and and humidity monitoring of stability
humidity monitoring of chambers (real time and accelerated)
stability chambers (real submitted.
270. Name, address of Applicant / M/s Wimits Pharmaceuticals (Pvt) Ltd. Lahore
Marketing Authorization Holder
Name, address of Manufacturing M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot #129
site. Sundar Industrial Estate, Raiwind road, Lahore
☐ Importer
Intended use of pharmaceutical ☐Domestic sale
Metacor 1000mg tablet
brand name
Active Pharmaceutical ingredient Metformin HCl …….1000mg
(API) per unit

Pharmaceutical form of applied White colored oval Film coated engraved with ‘W’
drug on one side of tablet
Oral Hypoglycemic agent
(API)
BP
specifications
The status in reference regulatory Glucophage 1000mg tablet by M/s Martin Dow,
For generic drugs (me-too status) Neodiper 1g tablet by M/s Sanofi Aventis Reg.
No. 026929
GMP status of the Finished cGMP certificate on the basis of evaluation
product manufacturer conducted on 08-09-2021
Name and address of API M/s AARTI DRUGS LIMITED
manufacturer. Plot No 211 & 213, Road -2, G.I.D.C AT & Post
Sarigam. City Sarigam– 396 155 Dist. Valsad
Gujarat
industrial estate India.
Module III (Drug Substance) Official monograph of Metformin Hydrochloride
is present in BP. The firm as submitted detail of
tests for impurity A,B,C,E &F, related substances
(Xyline), specifications, analytical procedures and
months
months

comparative dissolution profile against the brand leader that is Glucophage 1g
tablet by Martin Dow by performing quality tests
dosage form).
that is Glucophage 1g tablet by Martin Dow in
Acid media (pH-1.2),Acetate Buffer(pH-4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and
specificity.
Manufacturer of API M/s AARTI DRUGS LIMITED
Plot No 211 & 213, Road -2, G.I.D.C AT & Post Sarigam. City
Sarigam– 396
155 Dist. Valsad Gujarat industrial estate India.
API Lot No. MEF119102522
Description of Pack
(Container closure Alu-PVC blister packed in unit carton (5×10’s)
system)
Frequency Accelerated: 0, 1,2 3, 6 (Months)
Batch No. TMR002 TMR003 TMR004
No. of Batches 03
1. Reference of previous approval of Not provided.
2. Approval of API/ DML/GMP Copy of GMP certificate No. 20031933 issued by
certificate of API manufacturer Food & Drug Control administration Gujrat state
issued by concerned regulatory India valid till 19-03-2023.
3. Documents for the procurement of Firm has submitted copy of invoice (invoice#
API with approval from DRAP (in EXP/1879/10-20) dated : 01-11-2019 cleared by
case of import). DRAP Lahore office dated 18.11-2019 specifying
import of Metformin HCl (Batch#
MEF119102522).

data sheets etc.
software 21CFR & audit trail U.V method is used
for temperature & humidity monitoring of stability
The BP monograph for metformin tablet specifies UV method for assay testing.
Decision: Approved with BP specification.
271. Name, address of Applicant / M/s Horizon Healthcare (Pvt) Ltd. Plot No.33-
Marketing Authorization Holder Sundar Industrial Estate Lahore- Pakistan
Name, address of Manufacturing M/s Horizon Healthcare (Pvt) Ltd. Plot No.33-
site. Sundar Industrial Estate Lahore- Pakistan
☐ Importer
The proposed proprietary name / Rupri Tablet 1mg
brand name
Strength / concentration of drug of Each Film Coated Tablet Contains:
Active Pharmaceutical ingredient Prucalopride Succinate Eq To Prucaloprid…1mg
(API) per unit
Film coated Tablet
drug
Pharmacotherapeutic Group of High affinity 5HT4 receptor antagonist (Other
(API) drugs for constipation
ATC code: A06AX05)_
Innovator Specification
specifications

MOTEGRITY of USFDA approved
authorities
For generic drugs (me-too status) Not available
product manufacturer conducted
on03-06-2021
Name and address of API M/s Kimia Biosciences Limited, (Formerly
manufacturer. Known as Laurel Organics Limited)Village
Bhondsi Tehsil-Sohna District-Gurgoan Harryana,
India
Evaluation by PEC: Firm applied products Rupri 1mg Tablet (Prucalopride ) on form
5D afterward also applied same product on form 5F. Form 5D case was evaluated
earlier and presented in 317th meeting of DRB and was approved by DRB.(Case no 57
of 317th meeting).
Firm Response: With reference to our form 5F application submitted on December
9th, 2021 for our product mentioned in subject this is to explain here that we submitted
application of Prucalopride on form 5D as well and it is approve in registration board
meeting No 317th for our Horizon Healthcare Pvt Limited Lahore.
We hereby request your good office for withdrawal of our submitted application of
Prucalopride submitted on form 5F.
Decision: Registration Board acceded the firm’s request and decided to reject
Rupri 1mg Tablet (Prucalopride ).
272. Name, address of Applicant / M/s Horizon Healthcare (Pvt) Ltd. Plot No.33-
Marketing Authorization Holder Sundar Industrial Estate Lahore- Pakistan
Name, address of Manufacturing M/s Horizon Healthcare (Pvt) Ltd. Plot No.33-
site. Sundar Industrial Estate Lahore- Pakistan
☐ Importer
The proposed proprietary name / Rupri Tablet 2mg
brand name
Strength / concentration of drug of Each Film Coated Tablet Contains:
Active Pharmaceutical ingredient Prucalopride Succinate Eq To Prucaloprid…2mg
(API) per unit
Film coated Tablet
drug
Pharmacotherapeutic Group of High affinity 5HT4 receptor antagonist (Other
(API) drugs for constipation
ATC code: A06AX05)_

specifications
MOTEGRITY of USFDA approved
authorities
For generic drugs (me-too status) Not available
product manufacturer conducted
on03-06-2021
Name and address of API M/s Kimia Biosciences Limited, (Formerly
manufacturer. Known as Laurel Organics Limited)Village
Bhondsi Tehsil-Sohna District-Gurgoan Harryana,
India
Evaluation by PEC: Firm applied products Rupri 2mg Tablet (Prucalopride ) on form
5D afterward also applied same product on form 5F. Form 5D case was evaluated
earlier and presented in 317th meeting of DRB and was approved by DRB.(Case no 58
of 317th meeting).
Firm Response: With reference to our form 5F application submitted on December
9th, 2021 for our product mentioned in subject this is to explain here that we submitted
application of Prucalopride on form 5D as well and its approve in registration board
meeting No 317th for our Horizon Healthcare Pvt Limited Lahore.
We hereby request your good office for withdrawal of our submitted application of
Prucalopride submitted on form 5F.
Decision: Registration Board acceded the firm’s request and decided to reject
Rupri 2mg Tablet (Prucalopride ).
273. Name, address of Applicant / M/s Ferozsons Laboratories Ltd.
Marketing Authorization Holder P.O Ferozsons, Amangarh, Nowshera-Khyber
Pakhtunkhwa
Name, address of Manufacturing site. M/s Ferozsons Laboratories Ltd.
P.O Ferozsons, Amangarh, Nowshera-Khyber
Pakhtunkhwa
☐ Importer
giver)
Dakardi 5mg tablet
brand name
Active Pharmaceutical ingredient Dapagliflozin propanediol monohydrate eq to
(API) per unit Dapagliflozin …….5mg

Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Antidiabetic Drug (Sodium-glucose co-
transporters 2 (SGLT2) inhibitor)
specifications
Proposed Pack size 10’s, 14’s, 20’s, 28’s and 30’s
The status in reference regulatory Farxiga 5mg tablet by AstraZeneca
authorities Pharmaceuticals LP Wilmington, DE 19850,
USFDA Approved
For generic drugs (me-too status) Dapwiz 5mg Tablets by M/s Pharmevo Pvt Ltd.
- Karachi, Reg. No. 107374
GMP status of the Finished product cGMP certificate on the basis of evaluation
manufacturer conductd on 25-01-2019 and valid for 03 years.
Name and address of API M/s Fuxin Long Rui Pharmaceutical Co, Ltd –
manufacturer. China
Address: Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City,
Liaoning Province – 123000 China
submitted.
Module III (Drug Substance) Dapagliflozin is Inhouse, the firm submitted
manufacturers, tests for single/total impurities,
substance.
months
months
Batches: (160108, 160124, 160220)
procedure (including dissolution testing at acidic
and buffer medium) and its verification studies,

Farxiga 5mg tablet by AstraZeneca
Pharmaceuticals, by performing quality tests
(Identification, Assay, Dissolution, Uniformity
of dosage form).
that is Farxiga 5mg tablet by AstraZeneca
Pharmaceuticals. The dissolution profile of
Dakardi 5mg Tablets and Farxiga 5mg Tablet
has shown release of more than 85 % in all three
Buffer pH 1.2, Phosphate Buffer pH 6.8 and
Acetate Buffer pH 4.5 in 30 minutes. And no
calculation is required for Similarity factor f2
hence dissolution profile of both Dakardi 5mg
tablets and Farxiga 5mg tablet is similar.
specificity.
Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co, Ltd – China
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province – 123000 China
API Lot No. DG-20200107-D01-DG06-01
Description of Pack
01 Alu-Alu blister of 14 tablets, packed in cardboard box (Box of 14
(Container closure
tablets)
system)
Batch No. DGTab-001 DGTab-002 DGTab-003
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of
applications with stability study data their product EMPAGEN 10mg & 25mg which
of the firm (if any) was conducted on 24-08-2021 and was presented
in 294th meeting of Registration Board held on
9th April , 2020.
According to the report following points were
confirmed.

• The firm has 21 CFR compliant HPLC
software
• The firm possesses stability chambers
with digital data loggers.
2. Approval of API/ DML/GMP Copy of DML Registration. No. Liao20150233
certificate of API manufacturer issued issued by Food and Drug Administration of
by concerned regulatory authority of Liaoning Province-China valid till 20/12/2022
country of origin.
3. Documents for the procurement of Firm has submitted copy of form 6 , , DRAP
API with approval from DRAP (in acknowledgment for receiving of dapagliflozin
case of import). ,form3, form 7 and invoice
(invoice#HN200716-L) dated : 16-07-2020
specifying import of Dapagliflozin propanediol
monohydrate (Batch# DG-20200107-D01-
DG06-01).
sheets etc.
testing
Submitted
accelerated)
o Communicated
1. 3.2.P.5.3 Protocols of analytical Protocols of analytical validation studies
validation studies not submitted
submitted.
2. 3.2.P.5.4 In COA’s Inhouse Revised COA’s with Innovator’s
specifications mentioned specifications are submitted.
while in section 1.5.6
Innovator specifications
claimed. Clarification is
required.
3. 3.2.P.8 Submit Commercial Drug substance was imported against form-6
invoice with approval and the DRAP-Peshawar office was also
from DRAP. intimated regarding receiving of the same.
Both Copy of form 6 , DRAP
acknowledgment for receiving of
dapagliflozin are attached. That’s why
commercial invoice with DRAP approval
was not granted.
Decision:
Approved with innovator’s specification.

• Firm shall submit the fee of Rs. 7,500 for revision of specifications, as per
274. Name, address of Applicant / M/s Ferozsons Laboratories Ltd.
Marketing Authorization Holder P.O Ferozsons, Amangarh, Nowshera-Khyber
Pakhtunkhwa
Name, address of Manufacturing site. M/s Ferozsons Laboratories Ltd.
P.O Ferozsons, Amangarh, Nowshera-Khyber
Pakhtunkhwa
☐ Importer
giver)
Dakardi 10mg Tablets
brand name
Strength / concentration of drug of Each film coated tablet contains;
Active Pharmaceutical ingredient Dapagliflozin propanediol monohydrate eq. to
(API) per unit Dapagliflozin…..10mg
Pharmaceutical form of applied drug Blue, Round, biconvex coated tablet having “f”
on one side and plain on other side
Pharmacotherapeutic Group of (API) Antidiabetic Drug (Sodium-glucose co-
transporters 2 (SGLT2) inhibitor)
specifications
Proposed Pack size 10’s, 14’s, 20’s, 28’s and 30’s
The status in reference regulatory Farxiga 10mg tablet by AstraZeneca
authorities Pharmaceuticals LP Wilmington, DE 19850,
USFDA Approved
For generic drugs (me-too status) Dapwiz 10mg Tablets by M/s Pharmevo Pvt Ltd.
- Karachi, Reg. No. 107375
GMP status of the Finished product cGMP certificate on the basis of evaluation
manufacturer conductd on 25-01-2019 and valid for 03 years.
Name and address of API M/s Fuxin Long Rui Pharmaceutical Co, Ltd –
manufacturer. China
Address: Fluoride Industrial Park, Fumeng
County (Yi Ma Tu), Fuxin City,
Liaoning Province – 123000 China

submitted.
Module III (Drug Substance) Dapagliflozin is Inhouse, the firm submitted
manufacturers, tests for single/total impurities,
substance.
months
months
Batches: (160108, 160124, 160220)
Farxiga 10mg tablet by AstraZeneca
Pharmaceuticals, by performing quality tests
of dosage form).
that is Farxiga 10mg tablet by AstraZeneca
Pharmaceuticals. The dissolution profile of
Dakardi 10mg Tablets and Farxiga 10mg Tablet
has shown release of more than 85 % in all three
Buffer pH 1.2, Phosphate Buffer pH 6.8 and
Acetate Buffer pH 4.5 in 30 minutes. And no
calculation is required for Similarity factor f2
hence dissolution profile of both Dakardi 10mg
tablets and Farxiga 10mg tablet is similar.
specificity.

Manufacturer of API M/s Fuxin Long Rui Pharmaceutical Co, Ltd – China
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu),
Fuxin City, Liaoning Province – 123000 China
API Lot No. DG-20200107-D01-DG06-01
Description of Pack
01 Alu-Alu blister of 14 tablets, packed in cardboard box (Box of 14
(Container closure
tablets)
system)
Batch No. DGTab-004 DGTab-005 DGTab-006
No. of Batches 03
1. Reference of previous approval of Firm has referred to onsite inspection report of
applications with stability study data their product EMPAGEN 10mg & 25mg which
of the firm (if any) was conducted on 24-08-2021 and was presented
in 294th meeting of Registration Board held on
9th April , 2020.
According to the report following points were
confirmed.
• The firm has 21 CFR compliant HPLC
software
• The firm possesses stability chambers
with digital data loggers.
2. Approval of API/ DML/GMP Copy of DML Registration. No. Liao20150233
certificate of API manufacturer issued issued by Food and Drug Administration of
by concerned regulatory authority of Liaoning Province-China valid till 20/12/2022
country of origin.
3. Documents for the procurement of Firm has submitted copy of form 6 , , DRAP
API with approval from DRAP (in acknowledgment for receiving of dapagliflozin
case of import). ,form3, form 7 and invoice
(invoice#HN200716-L) dated : 16-07-2020
specifying import of Dapagliflozin propanediol
monohydrate 50gm (Batch# DG-20200107-
D01-DG06-01).
sheets etc.

testing
Submitted
accelerated)
o Communicated
1. 3.2.P.5.3 Protocols of analytical Protocols of analytical validation studies
validation studies not submitted
submitted.
2. 3.2.P.5.4 In COA’s Inhouse Revised COA’s with Innovator’s
specifications mentioned specifications are submitted.
while in section 1.5.6
claimed. Clarification is
required.
3. 3.2.P.8 Submit Commercial Drug substance was imported against form-6
invoice with approval and the DRAP-Peshawar office was also
from DRAP. intimated regarding receiving of the same.
Both Copy of form 6 , DRAP
acknowledgment for receiving of
dapagliflozin are attached. That’s why
commercial invoice with DRAP approval
was not granted.
Decision:
Approved with innovator’s specification.
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
275. Name, address of Applicant / Bryon Pharmaceuticals Pvt Ltd.
Marketing Authorization Holder 48-Indutiral estate Hayatabad Peshawar
Pakistan
Name, address of Manufacturing site. Bryon Pharmaceuticals Pvt Ltd.
48-Indutiral estate Hayatabad Peshawar
Pakistan
☐ Importer
giver)

GLYCEM 500mg tablet
brand name
Active Pharmaceutical ingredient Metformin HCL …….500mg
(API) per unit
Pharmaceutical form of applied drug White Film coated Oblong biconvex tablets
having score on one side.
Pharmacotherapeutic Group of (API) Anti-diabetic ATC Code:A10BA02
USP
specifications
The status in reference regulatory GLUCOPHAGE Tablets 500 mg by M/s Martin
authorities Dow Marker Ltd, USFDA Approved.
For generic drugs (me-too status) NEOPHAGE 500 mg Tablets by M/s
ABBOTT Laboratories Pakistan Ltd Reg. No.
025526
GMP status of the Finished product Last GMP inspection conducted on 17-10-2019
manufacturer and reports concludes that firm may be
considered operating at satisfactory level of
cGMP compliance
Name and address of API M/s Smruthi Organics Limited.
manufacturer. Plot No: A-27, M.I.D.C. Chincholi, Taluka
Mohol Solapur. - 413 255 Maharashtra.
INDIA.
submitted.
Module III (Drug Substance) Official monograph of Metformin
Hydrochloride is present in BP. The firm as
process and controls, tests for impurity etc &
related substances (impurity & unspecified),

substance
months
months
Batches: (MFH-001/07, MFH-002/07, MFH-
003/07,)

GLUCOPHAGE 500mg Tablets by M/S Martin
Dow Marker Ltd by performing quality tests
of dosage form).
that is Glucophage 500mg tablet by M/S Martin
Dow Marker Ltd in Acid media (pH 1.2, 4.5) &
Phosphate Buffer (pH 6.8). The values for f1 and
specificty.
Manufacturer of M/s Smruthi Organics Limited. Plot No: A-27, M.I.D.C. Chincholi,
API Taluka Mohol Solapur 4 1 3 2 5 5 Maharashtra. INDIA.
API Lot No. MET-587/19
Description of Pack
system)
Frequency Accelerated: 0, 1, 2,3 & 6 (Months)
Real Time: 0, 1,3, 6 ,9,12,18 (Months)
Batch No. TB-295 TB-296 TB-297

No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. NEW-WHO-
certificate of API manufacturer issued GMP/CERT/PD/86368/2019/11/30111 issued
by concerned regulatory authority of by F&DA Maharashtra State INDIA valid till
country of origin. 13/11/2022.
3. Documents for the procurement of Firm has submitted copy of form 5, form 3
API with approval from DRAP (in form 7 & invoice (invoice# E-038) dated : 31-
case of import). 05-2019 cleared by DRAP Peshawar office
dated 13.06-2019 specifying import of
Metformin HCl (Batch# Met-587/19).
4. Data of stability batches will be Firm has submitted data of stability batches
supported by attested respective along with batch manufacturing record,
documents like chromatograms, analytical record and attested documents like
Raw data sheets, COA, summary data chromatograms, Raw data sheets, COA,
sheets etc. summary data sheets etc.
5. Compliance Record of HPLC software Firm has submitted compliance certificate of
21CFR & audit trail reports on product HPLC software and audit trail reports on product
testing testing.
for temperature & humidity monitoring of
accelerated)
o Communicated
Manufacturing Record the batches of drug product are submitted.
(BMR) for all the batches
provided in Module 3 s
2. 2.3.R.1.2 Provide blank master Blank master production document / batch
production document / manufacturing record to be used during the
batch manufacturing commercial manufacturing of the applied
record to be used during product is submitted.
the commercial
manufacturing of the
applied product
3. 3.2.S.4.1 • Copies of the Drug • Copies of the Drug substance
specifications and procedures used for routine testing of
analytical procedures the Drug substance /Active
used for routine testing Pharmaceutical Ingredient by both
of the Drug substance Drug substance & Drug Product
/Active Pharmaceutical manufacturer is submitted.
Ingredient by both

Drug substance & • The drug substance specification is
Drug Product BP while Drug product is claimed
manufacturer is USP.
required. 1) The API manufacturer /Source
• Specification claimed claims its specification a per BP
for drug substance are and DMF data provided as per BP
B.P while drug product specification.
specification claimed 2) Finished Product/ Drug product is
are USP. Clarification available I both USP and BP
is required why B.P As per DRAP guidelines if Drug
grade material is used. product is available in various
pharmacopeia priority order of
Label claims specifications
should be USP, BP, Eur and
Japanese etc, so by following
guidelines of DRAP we claim our
Drug product as per USP.
4. 3.2.S.4.3 Method Verification Method Verification studies including

studies including performed by the Drug Product manufacturer
specificity, accuracy and for drug substance is submitted.
repeatability (method
precision) performed by
the Drug Product
manufacturer for drug
substance(s) Shall be
submitted.
5. 3.2.S.4.5 COA of primary / COA of primary / secondary reference
secondary reference standard is submitted.
standard including source
and lot number shall be
provided
6. 3.2.P.5.1 From specification of Dissolution Test 1 applied.
dissolution testing of drug
product it is not evident
which test of dissolution
from USP monograph was
adopted. Clarification is
required.
7. 3.2.P.8 • Documents for the Submitted.
procurement of
with approval from
DRAP.
commitment submitted in the registration application

Case no. 02 Registration applications on Form 5 for local manufacturing of (Human)
drugs
a. Deferred cases (Form 5)
276. Name and address of M/s Mediate Pharmaceutical Pvt Ltd.

manufacturer / Applicant Plot No. 150-151, Sector 24, Korangi Industrial
Area, Karchi, Pakistan
Brand Name +Dosage Form + Medforge 5/80/12.5mg Tablet
Strength
Amlodipine as besylate…5mg
Valsartan…80mg
Hydrochlorothiazide…12.5mg
Diary No. Date of R& I & fee Dy.No. 9806 dated 04-03-2019 Rs.20,000/- Dated 04-
02-2019
Pharmacological Group Anti-hypertension
Type of Form Form-5
Finished product Specifications USP
Approval status of product in Not found
Authorities
Me-too status Not found
GMP status Last GMP inspection conducted on 02-04-2019,
and report concludes firm was considered to be
operating at an acceptable level of good compliance with
GMP guidelines
Remarks of the Evaluator Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275th
meeting
Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
Previous decision Deferred for following:
• Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along
with registration number, brand name and name of
firm.
• Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
adopted by the Registration Board.(M-295)
Evaluation by PEC: Now firm change formulations without submission of fee and also firm
said that consider the same fee as for “Medforge 5/80/12.5mg Tablet”. Formulation is as
follows
Brand Name +Dosage Form + Medforge 5/160/12.5mg Tablet
Strength
Valsartan…160mg
Hydrochlorothiazide…25mg
Approval status of product in Exforge HCT 5/160/25 by Novartis (USFDA)

Me-too status Exforge HCT By Novartis (Reg. No. 069549)
Previous Decision ( M- 317): Deferred for clarification whether in applied formulation
Hydrochlorthiazide is 25mg or 12.5mg.
Evaluation by PEC: Firm replied that they have registered product Alpertan Tablet
5/160/12.5mg so request for change of formulation without submission of fee as follows
Brand Name +Dosage Form + Medforge 5/80Tablet
Strength
Valsartan…80mg
Approval status of product in Exforge 5/80 by Novartis (USFDA)
Me-too status Exforge By Novartis (Reg. No. 047569)
• Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in
composition (correction/change Strength of the drug substance), as per
277. Name and address of M/s Aries Pharmaceuticals.
manufacturer / Applicant 1-W, Industrial Estate, Hayatabad, Peshawar, k.p.k
Brand Name +Dosage Form + Dron 70mg Tablet
Strength
Alendronate Sodium Eq. to Alendronic
Acid…70mg
03-2019
Pharmacological Group Bisphosphonate ( Antiosteoporotic)
Type of Form Form 5
Finished product Specifications Manufacturer’s specification
Approval status of product in Alendronic Acid 70mg of MHRA approved
Authorities
Me-too status (with strength and Bonafide Tablets 70mg by M/s Medisure Labs.
dosage form)
GMP status cGMP certificate on the basis of Evaluation conducted on
06-04-2022 and valid for two (02) Years.
Previous remarks of the
Evaluator.
Previous decision(s) Deferred for following reasons:
Deferred for consideration on its turn. (M-296)
Remarks of the Evaluator. Available in USP Pharmacopeia
05-2021.
Brand Name +Dosage Form + Aricure 50mg/5ml IV Injection
Strength
Composition Each 5ml Ampoule Contains:
Atracurium Besylate…50mg

03-2019
Pharmacological Group Non depolarizing muscle relaxant
Type of Form Form 5
Approval status of product in Tracrium Injection10mg/ml of MHRA approved
Authorities
Me-too status (with strength and Atrium Injections by M/s Searle Pakistan, Karachi
dosage form) (Reg#053342)
Evaluator.
Decision: Approved with USP specifications .
Brand Name +Dosage Form + Aripine 1mg/ml Injection
Strength
Atropine Sulphate…1mg
03-2019
Pharmacological Group Anticholinergic
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Approval status of product in Atropine Sulfate Injection 1mg in 1 ml of MHRA
Reference Regulatory approved
Authorities
Me-too status (with strength and Swiss Atropine 1mg/ml Injectionof M/s Swiss pharma,
Evaluator.
Remarks of the Evaluator. Available in USP pharmacopeia
Decision: Approved with USP Specifications.
05-2021.
Brand Name +Dosage Form + Bamral 20mg Tablet
Strength
Bambuterol Hcl…20mg

03-2019
Pharmacological Group Long acting beta adrenoceptor agonist
Type of Form Form 5
Finished product Specifications Manufacturers specifications
Approval status of product in Bambec Tablet of (MHRA Approved)
Authorities
Me-too status (with strength and Basthma tablet 10mg of M/s Polyfine Chempharma
dosage form)
Evaluator.
Decision: Approved with Innovator’ specifications.
05-2021.
Brand Name +Dosage Form + Clomix 75mg Tablet
Strength
Clomipramine HCl……75mg
03-2019
Pharmacological Group Antidepressant
Type of Form Form 5
Approval status of product in Clomipramine HCl by sandoz ANSM france Approved
Authorities
Me-too status (with strength and Clomipril Tablets of M/s Libra Reg# 027816
dosage form)
Evaluator.
05-2021.
Brand Name +Dosage Form + Desatil 2.5mg/5ml Syrup
Strength

Composition Each 5ml contains:
Desloratadine…2.5mg
03-2019
Pharmacological Group Antiallergic
Type of Form Form 5
Approval status of product in Clarinex of (USFDA approved)
Authorities
Me-too status (with strength and Desora Syrup by M/s S.J &G. Fazul Ellahie
dosage form)
Evaluator.
05-2021.
Brand Name +Dosage Form + Ibudex 200mg Tablet
Strength
Dexibuprofen…200mg
03-2019
Pharmacological Group NSIADs
Type of Form Form 5
Pack size & Demanded Price As Per SRO
Approval status of product in Dexibuprofen of (MHRA approved)
Authorities
Me-too status (with strength and Bekonil 200mg Tablet of M/s Martin Dow
dosage form)
Evaluator.
05-2021.

Brand Name +Dosage Form + Arinate 50mg/ml Injection
Strength
Dimenhydrinate…50mg
03-2019
Pharmacological Group Antihistamine
Type of Form Form 5
Approval status of product in Dimenhydrinate Inj of Fresenius kabi, USFDA
Authorities
Me-too status (with strength and Dirinate Injection Each Ml Ampoule Contains:-
dosage form) Dime of M/s Elite Pharma
Evaluator.
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
Brand Name +Dosage Form + Co-Besart 300/12.5 mg Tablet
Strength
Irbesartan…300mg
03-2019
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form 5
Approval status of product in AVALIDE of ( USFDA approved)
Authorities
Me-too status (with strength and Irbest Plus Tablets of M/s Highnoon Laboratories
dosage form)
Evaluator.

Brand Name +Dosage Form + Ketalog 500mg/10ml Injection
Strength
Ketamine Hcl Eq. to Ketamine…500mg
03-2019
Pharmacological Group General Anesthesic
Type of Form Form 5
Pack size & Demanded Price 2ml x 5’s ; As per SRO
Approval status of product in Ketalar 50 mg/ml Injection, of MHRA approved 10ml
Authorities
Me-too status (with strength and Katafast 500mg Injection by M/s Vision
dosage form)
Evaluator.
Brand Name +Dosage Form + Ketor 30mg/ml Injection
Strength
Composition Each 1ml ampoule contains:
Ketorolac Tromethamine…30mg
03-2019
Pharmacological Group Analgesic
Type of Form Form 5
Approval status of product in Toradol 30mg/ml of TGA approved
Authorities
Me-too status (with strength and Ketopan Injection 30mg by M/s Welwrd
dosage form) Pharmaceuticals,
Evaluator.
Brand Name +Dosage Form + Aricain 10mg/ml Injection
Strength
Lidocaine Hcl…10mg

03-2019
Pharmacological Group Local anaesthetic
Type of Form Form 5
Approval status of product in Lidocaine Injection 1% w/v (MHRA approved)
Authorities
Me-too status (with strength and Lacain 1% Injection of M/s. Pulse
dosage form) Pharmaceuticals
Evaluator.
Brand Name +Dosage Form + Co-Locor 50/12.5 mg Tablet
Strength
Losartan Potassium…50mg
03-2019
Pharmacological Group Antihypertensive(Angiotensin II Receptor
Antagonist,Thiazide Diuretic)
Type of Form Form 5
Approval status of product in Cozaar Comp 50 mg/12.5 mg of ( MHRA
Reference Regulatory Approved)
Authorities
Me-too status (with strength and Lotass Plus 50mg/12.5mg of M/S Getz pharma
dosage form)
Evaluator.
Brand Name +Dosage Form + Prox 37.5mg CR Tablet
Strength
Composition Each Enteric Film Coated Controlled Release Tablet
Contains:
Paroxetine Hcl Eq. to Paroxetine…37.5mg

03-2019
Pharmacological Group Selective serotonin-reuptake inhibitors
Type of Form Form 5
Approval status of product in PAXIL CR of (USFDA approved)
Authorities
Me-too status (with strength and Paraxyl CR M/s CCL Pharmaceuticals
dosage form)
Evaluator.
Brand Name +Dosage Form + Arixicam IM 20mg/ml Injection
Strength
Piroxicam…20mg
03-2019
Pharmacological Group Anti-rheumatic
Type of Form Form -5
Finished product Specifications Manufacturers specification
Authorities
Me-too status (with strength and Salden 20mg Injection of M/s Danas
dosage form) Pharmaceutical(Reg.#080373)
Evaluator.
05-2021.
Brand Name +Dosage Form + Thioside 4mg/2ml Injection
Strength
Thiocolchicoside……4mg

03-2019
Pharmacological Group Skeletal Muscle Relaxant
Type of Form Form-5
Approval status of product in Coltramyl Injection by M/s Sanofi Aventis
Reference Regulatory ANSM France
Authorities
Me-too status (with strength and Myovi 4mg/2ml Injection by Macter International
dosage form) (Reg. No. 058692)
Evaluator.
05-2021.
Brand Name +Dosage Form + Aricure 30mg/3ml Injection
Strength
Atracurium Besylate…30mg
03-2019
Pharmacological Group Non-depolarizing skeletal muscle relaxant
Type of Form Form-5
Authorities
Me-too status (with strength and Not found
dosage form)
Previous remarks of the • Evidence of approval of applied formulation in
Evaluator. reference regulatory authorities/agencies which
were declared/approved by the Registration Board in
its 275th meeting.
• Firm provided Atracurium 10mg/ml Solution for
Injection or Infusion of MHRA approved. But 3ml
volume not available in MHRA
• Evidence of approval of applied formulation in reference regulatory authorities /
agencies which were adopted by the Registration Board in its 275th meeting.

• Evidence of applied formulation/drug already approved by DRAP (generic / me-
Brand Name +Dosage Form + Bamral 5mg/5ml Syrup
Strength
Composition Each 5ml Contains:
Bambuterol Hcl…5mg
03-2019
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form 5
Finished product Specifications Manufacturers specifications
Approval status of product in Bambuterol juice 1mg/ml by AstraZaneca (Germany)
Authorities
Me-too status (with strength and Btno 5mg/5ml syrup by M/s Genix (Reg# 057873)
dosage form)
Evaluator.
05-2021.
Brand Name +Dosage Form + Dobicard 250mg/5ml IV Injection
Strength
Dobutamine Hcl…250mg
03-2019
Pharmacological Group General anesthetic
Type of Form Form-5
Finished product Specifications USP Specs.
Authorities
Me-too status (with strength and Botamin Injection by M/s Fynk Pharmaceuticals
dosage form)
Previous remarks of the Firm submitted fee of Rs: 5000/- Deposit slip No#
Evaluator. 1984287,Dated: and Revise formulation as follows
Dobicard 250mg/20ml IV Injection
Each 20ml Contains:
Dobutamine Hcl…250mg

Dobutrex dobutamine 250mg/20ml
injection solution of TGA approved
Dobutamine Injection 250mg/20ml of
Haji medicine ( Reg # 027345)
Decision: Approved with USP specifications as per following label claim:
Each 20ml Contains:
Dobutamine HCl…250mg
• Firm shall submit the remaining fee of Rs. 25,000 for correction/pre-approval
change in composition (correction/change of strength of drug substance), as per
Brand Name +Dosage Form + Levon 1.5mg Tablet
Strength
Levonorgestrel…1.5mg
03-2019
Pharmacological Group Hormonal contraceptives for systemic use
Type of Form Form -5
Finished product Specifications BP
Pack size & Demanded Price 1 x 10’s , 1 x 20’s, 1 x 30’s:as per SRO
Approval status of product in Ezinelle 1.5 mg tablet of MHRA approved
Authorities
Me-too status (with strength and Emkit-DS tablet 1.5mg of Zafa Pharma Reg # 032543.
dosage form)
Previous remarks of the The firm change formulation from film coated to un
Evaluator. coated with submission of fee of Rs: 5000/- Deposit slip
No # 1984286, Dated : 07-08-2020.
Decision: Approved with BP specifications.
change in composition (correction/change of formulation from film-coated
tablet to uncoated tablet), as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
Brand Name +Dosage Form + Mebofac MR 200mg Capsule
Strength
Composition Each Capsule Contains:
Enteric Coated Pellets Mebeverie Hcl 50% Eq. to
Mebeverie Hcl…200mg
03-2019
Pharmacological Group Anti-spasmodic
Type of Form Form-5

Finished product Specifications Manufacturers
Pack size & Demanded Price 10’s, 30’s & 40’s & as per SRO
Approval status of product in MHRA Approved
Authorities
Me-too status (with strength and Mebever MR capsule of M/s Getz Pakistan (050747)
dosage form)
Previous remarks of the Source of pellets : Vision pharmaceuticals
Evaluator.
05-2021.
Brand Name +Dosage Form + Averon 4mg Tablet
Strength
Composition Each film coated Tablet Contains:
Ondansetron Hcl Dihydrate Eq. to Ondansetron…….4mg
03-2019
Pharmacological Group Selective serotonin 5-HT3 receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s,50’s ; As per SRO
Approval status of product in ZOFRAN Of (USFDA Approved)
Authorities
Me-too status (with strength and Ondonix 4mg Tablet M/s Genix Pharma
dosage form)
Previous remarks of the • The firm change formulation from uncoated to film
Evaluator. coated with submission of fee of Rs: 5000/- Deposit
slip No # 1984285, Dated : 07-08-2020
change in composition (correction/change of formulation from un coated tablet
to film coated tablet), as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
299. Name and address of M/s Rotex Pharma Pvt Ltd.
manufacturer / Applicant Plot No. 206 & 207. Industrial Triangle, Kahuta
Road, Islamabad
Brand Name +Dosage Form + Exor-H 5/160/12.5 mg Tablet
Strength

Amlodipine Besylate Eq. to Amlodipine…5mg
Valsartan…160mg
03-2019
Pharmacological Group Anti-hypertensive
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s : As per SRO
Approval status of product in Exforge Hct Of ( USFDA Approved)
Authorities
Me-too status (with strength and Exforge Hct Of M/S Novartis Pharma
dosage form)
11-08-2022
Evaluator.
05-2021.
Road, Islamabad
Brand Name +Dosage Form + Adzon Gel
Strength
Composition Each Gm Contains:
Adapalene…1mg (0.1% w/w)
Benzoyl Peroxide…25mg (2.5% w/w)
03-2019
Pharmacological Group Retinoids for topical use in acne
Type of Form Form 5
Pack size & Demanded Price 15gm, 30gm, 45gm, 60gm & 90gm ; As per SRO
Approval status of product in Epiduo gel of (USFDA Approved)
Authorities
Me-too status (with strength and Adalen e-B Gel of M/s Pharmatec
11-08-2022
Evaluator.

05-2021.
Road, Islamabad
Brand Name +Dosage Form + I Rot Tablet 5mg
Strength
Folic Acid…5mg
03-2019
Pharmacological Group Vitamin B9
Type of Form Form 5
Pack size & Demanded Price 10’s,20’s, 30-‘s, 100’s: As per SRO
Authorities
Me-too status (with strength and Zal 5mg Tablets of M/s Alsons Pharmaceuticals
dosage form)
11-08-2022
Evaluator.
Road, Islamabad
Brand Name +Dosage Form + Rogex 80mg Injection
Strength
Composition Each 2ml Contains:
Gentamycin Sulphate Eq. to Gentamycin…80mg
03-2019
Pharmacological Group Aminoglycoside
Type of Form Form 5
Pack size & Demanded Price 2ml x 5’s : As per SRO
Approval status of product in Gentamicin 40 mg/ml, solution for injection/infusion of
Reference Regulatory MHRA approved
Authorities
Me-too status (with strength and Fengen Injection 80m of M/ Fynk Pharmaceuticals Reg
dosage form) # 065892
11-08-2022
Evaluator.

05-2021.
Road, Islamabad
Brand Name +Dosage Form + Ketrox 2% w/v Lotion
Strength
Ketoconazole…20mg
03-2019
Pharmacological Group Antifungal for topical use (Imidazole and triazole
derivative)
Type of Form Form-5
Finished product Specifications JP
Pack size & Demanded Price 60ml, 90ml :As per SRO
Approval status of product in Nizoral Anti-Dandruff Shampoo by M/s McNeil
Reference Regulatory Products Limited (MHRA Approved)
Authorities
Me-too status (with strength and Ketonaz Lotion by M/s Sante (Reg#073453)
dosage form)
11-08-2022
Evaluator.
Remarks of the Evaluator. Shampoo available in BP pharmacopeia
Decision: Approved with BP specifications as per following brand name and label
claim:
Ketrox 2% w/w Shampoo
Each gram of shampoo contains:
Ketoconazole……20mg
• Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in
composition (correction/change of salt form of the drug substance), as per
Road, Islamabad
Brand Name +Dosage Form + Zefen 1mg Tablet
Strength
Ketotifen Hydrogen Fumarate eq to Ketotifen……..1mg
03-2019
Pharmacological Group Antihistamines
Type of Form Form-5
Finished product Specifications Manufacturer Specification
Pack size & Demanded Price 20’s, 30’s; As per SRO
Approval status of product in ZADITEN of (MHRA approved)
Authorities

Me-too status (with strength and Bronk 1 mg Tablet of Semos Pharmaceuticals
dosage form)
11-08-2022
Evaluator.
05-2021.
Road, Islamabad
Brand Name +Dosage Form + Maxotex 10mg Tablet
Strength
Metoclopramide HCl eq to Metoclopramide
(Anhydrous)…10mg
03-2019
Pharmacological Group Anti-dopaminergic
Type of Form Form 5
Pack size & Demanded Price 10’s, 100’s: As per SRO
Approval status of product in Maxolon 10mg Tablets of MHRA approved
Authorities
Me-too status (with strength and Faclomide 10mg Tablets of M/s Farm Aid Group
dosage form)
11-08-2022
Evaluator.
Road, Islamabad
Brand Name +Dosage Form + Dekzol 2% w/w Oral Gel
Strength
Miconazole…20mg
03-2019
Pharmacological Group Antiinfective/ Antiseptic
Type of Form Form 5
Pack size & Demanded Price 20gm: As per SRO
Approval status of product in Daktarin Oral Gel of MHRA approved

Authorities
Me-too status (with strength and Miconit Oral Gel 2% of M/s Bio-Labs
dosage form) (Reg. # 054776)
11-08-2022
Evaluator.
05-2021.
Road, Islamabad
Brand Name +Dosage Form + Rifapen Forte Tablet
Strength
Rifampicin…150mg
Isoniazid…75mg
Ethambutol Hcl…275mg
Pyrazinamide…400mg
03-2019
Pharmacological Group Anti-tubercular drugs
Type of Form Form 5
Finished product Specifications IP
Pack size & Demanded Price 50’s, 80’s, 100’s: As per SRO
Approval status of product in Rimstar, 150 mg/75 mg/400 mg/275 mg film-
Reference Regulatory coated tablet. by M/s Sandoz (Swedish Medical
Authorities Products Agency Approved)
Me-too status (with strength and Myrin P Forte Tablets by M/s Wyeth, (Reg#027082)
dosage form)
11-08-2022
Evaluator.
Remarks of the Evaluator. WHO prequalified
Decision: Approved with International Pharmacopoeia specifications.
Road, Islamabad
Brand Name +Dosage Form + Rocept Injection 440mg/20ml
Strength
Trastuzumab…440mg
02-2019
Pharmacological Group Monoclonal antibody

Type of Form Form 5
Pack size & Demanded Price 20ml x 1’s: As per SRO
Authorities
Me-too status (with strength and HERCEPTIN 440MG by M/s ROCHE
dosage form)
11-08-2022
Evaluator.
Decision: Registration Board referred the case to biological division.
Road, Islamabad
Brand Name +Dosage Form + Warfix 5mg Tablet
Strength
Warfarin Sodium…5mg
03-2019
Pharmacological Group Thromboembolic conditions
Type of Form Form 5
Pack size & Demanded Price 100’s,: As per SRO
Approval status of product in COUMADIN of USFDA approved
Authorities
Me-too status (with strength and Coagurin 5mg Tablets of M/s Atco Laboratories
dosage form)
11-08-2022
Evaluator.
Road, Islamabad
Brand Name +Dosage Form + Clintop Gel
Strength
Composition Each gm Contains:
Clindamycin as phosphate….10mg
03-2019
Pharmacological Group Anti-infective
Type of Form Form 5

Pack size & Demanded Price 10gm, 20gm : As per SRO
Approval status of product in RESIDERM 1%w/w GEL (MHRA approved)
Authorities
Me-too status (with strength and Sixil 10mg/g Gel of M/s Sigma Pharma (Reg # 079912)
dosage form)
11-08-2022
Evaluator.
311. Name and address of M/s Genix Pharma Pvt Ltd.
manufacturer / Applicant 44,45-B, Korangi Creek Road, Karachi, 75190,
Pakistan
Brand Name +Dosage Form + Edoban 15mg Tablet
Strength
Edoxaban Tosilate Eq. to Edoxaban…15mg
03-2019
Pharmacological Group Antithrombotic agent
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s : As per SRO
Approval status of product in Lixiana 15 mg film-coated tablets of MHRA
Authorities
dosage form)
GMP status Last inspection was conducted on 12-02-2020 and
report concludes that Based on the area inspected. The
people met and the document reviewed and considering
the findings of the inspection firm was considered to be
operating at a good level of compliance with cGMP
guideline as of today.
Previous remarks of the Submit Stability studies along with requisite documents.
Evaluator.
Decision: Registration Board deferred the case for submission of stability study data as
per the guidelines provided in 293rd meeting of Registration Board.
Pakistan
Brand Name +Dosage Form + Ercaf 1/100 mg Tablet
Strength
Ergotamine Tartrate…1mg
Caffeine…100mg

03-2019
Pharmacological Group Ergot Alkaloid/ Xanthine
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s: As per SRO
Approval status of product in Cafergot of USFDA approved
Authorities
Me-too status (with strength and Cafergot TAB of M/s SANDOZ
dosage form)
Evaluator.
Pakistan
Brand Name +Dosage Form + Fidox 200mg Tablet
Strength
Fidaxomicin…200mg
03-2019
Finished product Specifications Manufacturer specification
Pack size & Demanded Price 10’s,c 20’s, 30’s: As per SRO
Approval status of product in DIFICLIR 200 mg film-coated tablets of MHRA
Authorities
dosage form)
Evaluator.

Pakistan
Brand Name +Dosage Form + Verlin 1mg Tablet
Strength
Varenicline Tartrate Eq. to Varenicline…1mg
03-2019
Pharmacological Group Nicotinic acetylcholine receptor partial agonist/smoking
cessation aid
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As per SRO
Approval status of product in Prograf of USFDA approved
Authorities
Me-too status (with strength and Chantix 1.0mg Of M/S Parke Davis &
dosage form) Company (Reg.# 045698)
Evaluator.
07-05-2021.
Pakistan
Brand Name +Dosage Form + Riocig 0.5mg Tablet
Strength
Riociguat…0.5mg
03-2019
Pharmacological Group Anti hypertensive
Pack size & Demanded Price 30’s, 60’s, :As per SRO
Approval status of product in Adempas of USFDA approved
Authorities
dosage form)

Evaluator.
Pakistan
Brand Name +Dosage Form + Pirnix 534 mg Tablet
Strength
Pirfenidone…534mg
03-2019
Pharmacological Group Anti-fibrotic
Pack size & Demanded Price 7’s, 14, 21;s :As per SRO
Approval status of product in Esbriet 534 mg film-coated tablets of MHRA approved
Authorities
dosage form)
Evaluator.
Pakistan
Brand Name +Dosage Form + Obecol 10mg Tablet
Strength
Obeticholic Acid…10mg
03-2019
Pharmacological Group Bile acid prepartions

Pack size & Demanded Price 10’s, 20, 30;s :As per SRO
Approval status of product in OCALIVA 5 mg film-coated tablets of MHRA
Authorities
dosage form)
Evaluator.
Road, Islamabad
Brand Name +Dosage Form + Zovir 250mg/10ml Injection
Strength
Composition Each 10ml Vial Contains:
Acyclovir…250mg
03-2019
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded Price 1’s (10ml); As per SRO
Approval status of product in Zovirax I.V. 250 mg of MHRA approved
Authorities
Me-too status (with strength and Aclovir 250mg Powder for infusion of Genix pharma
dosage form) Reg# 073690
11-08-2022
Evaluator.
Decision: Deferred for confirmation of required manufacturing facility / section
(lyophilized vial General section)
Road, Islamabad
Brand Name +Dosage Form + Zovir 500mg/20ml Injection
Strength
Composition Each 20ml vial Contains:
Acyclovir…500mg

03-2019
Pharmacological Group Antiviral
Type of Form Form 5
Pack size & Demanded Price 1’s (20ml) ; As per SRO
Approval status of product in Zovirax I.V. 500 mg of MHRA approved
Authorities
Me-too status (with strength and Aclovir 500mg Powder for infusion of Genix pharma
dosage form) Reg# 073691
GMP status CGMP certificate on the basis of Evaluation conducted
on 11-08-2022
Previous remarks of the • Evidence of applied formulation/drug already
Evaluator. approved by DRAP (generic / me-too status)
alongwith registration number, brand name and
name of firm.
(lyophilized vial General )
Road, Islamabad
Brand Name +Dosage Form + Beta One Lotion 0.1%
Strength
Betamethasone valerate…0.1% w/w
03-2019
Pharmacological Group Corticosteroids
Type of Form Form-5
Pack size & Demanded Price 60ml, As per SRO
Approval status of product in Betnovate Lotion 0.1% w/w by (MHRA
Reference Regulatory Approved
Authorities
Me-too status (with strength and Betamethasone Lotion by M/s Werrick
dosage form) Pharmaceuticals, (Reg# 051176)
on 11-08-2022
Evaluator.
Road, Islamabad
Brand Name +Dosage Form + Clintek Gel
Strength

Clindamycin Phosphate…12mg (1.2 % w/w)
Tretinoin…0.25mg (0.025% w/w)
03-2019
Pharmacological Group Anti-Acne (Treatment of acne vulgaris)
Type of Form Form-5
Pack size & Demanded Price 20gm ; As per SRO
Approval status of product in ZIANA (Gel) of USFDA approved
Authorities
Me-too status (with strength and Clin Gel 20g Gel of M/s Linta pharmaceuticals
dosage form)
on 11-08-2022
Evaluator.
07-05-2021.
Road, Islamabad
Brand Name +Dosage Form + Uric Tablet 120mg
Strength
Febuxostat…120mg
03-2019
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase
Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 20’s: As per SRO
Approval status of product in ADENURIC 120 mg film-coated tablets of MHRA
Authorities
Me-too status (with strength and Gouric 120mg Tablet of M/s Pharmevo (Reg #
dosage form) 080284)
on 11-08-2022
Evaluator.
07-05-2021.

Road, Islamabad
Brand Name +Dosage Form + Irofit Tablet 20mg/2.5mg
Strength
Iron protein succinylate 400mg eq to elemental iron
…20mg
Folic Acid……..2.5mg
03-2019
Pharmacological Group Antianemic preparations
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s , :As per SRO
Authorities
Me-too status (with strength and Eisen Tablets of Genome Pharmaceuticals
dosage form)
on 11-08-2022
Previous remarks of the Evidence of approval of applied formulation in
were declared/approved by the Registration
Board in its 275th meeting
Decision: The Board deferred the case for submission of detail of specifications and
complete analytical method for the applied product.
Road, Islamabad
Brand Name +Dosage Form + Methane 1% w/v Lotion
Strength
Permethrin…10mg
03-2019
Pharmacological Group Pyrethroid insecticide
Type of Form Form 5
Pack size & Demanded Price 30ml: As per SRO
Approval status of product in Nix lotion of USFDA approved
Authorities
dosage form)
on 11-08-2022
Previous remarks of the • Evidence of applied formulation/drug already
Evaluator. approved by DRAP (generic / me-too status)

along with registration number, brand name and
name of firm.
Decision: Deferred for evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) along with registration number, brand name and name
of firm.
Road, Islamabad
Brand Name +Dosage Form + Proman 10mg/ml Injection
Strength
Protamine sulphate…10mg
02-2019
Pharmacological Group Antidote to heparin
Type of Form Form 5
Pack size & Demanded Price 5ml x 1’s: As per SRO
Approval status of product in Protamine Sulfate 10mg/ml Solution for Injection
Reference Regulatory of MHRA approved
Authorities
Me-too status (with strength and Protamine Sulphate Injection of M/s Isman Drugs
dosage form) House Lahore. (Reg.# 008853)
on 11-08-2022
Previous remarks of the Source: Biological
Evaluator.
Decision: Registration Board referred the case to Biological Division.
Road, Islamabad
Brand Name +Dosage Form + Rancol xr 1000mg
Strength
Composition Each film coated extended release tablet contains:
Ranolazine…1000mg
03-2019
Pharmacological Group Anti-Anginal
Type of Form Form 5
Pack size & Demanded Price 14’s :As per SRO
Approval status of product in RANEXA of USFDA Approved
Authorities
Me-too status (with strength and Ranoline SR 1000mg Tablet (Reg# 078790) by
dosage form) Searle IV Solutions
on 11-08-2022

Evaluator.
07-05-2021.
manufacturer / Applicant 44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan
Brand Name +Dosage Form + Ilazole 10mg Tablet
Strength
Composition Each Enteric Coated Tablet Contains:
Ilaprazole……10mg
03-2019
Pharmacological Group Proton pump inhibitor
Pack size & Demanded Price 30’s, 60’s:As per SRO
Authorities
dosage form)
were declared/approved by the Registration Board
in its 275th meeting.
approved by DRAP (generic / me-too status)
name of firm.
• Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board.
manufacturer / Applicant 44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan
Brand Name +Dosage Form + Ilazole 20mg Tablet
Strength
Composition Each Enteric Coated Tablet Contains:
Ilaprazole……20mg

03-2019
Pack size & Demanded Price 30’s, 60’s:As per SRO
Authorities
dosage form)
were declared/approved by the Registration Board
in its 275th meeting.
approved by DRAP (generic / me-too status)
name of firm.
• Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board.
329. Name and address of M/s Medimarker's Labortaries Pvt Ltd
manufacturer / Applicant A-104, S.I.T.E Area, Hyderabad
Brand Name +Dosage Form + Cefmark 250mg/Vial I.M Dry Powd
Strength
Ceftriaxone as Sodium…250mg
Diary No. Date of R& I & fee Dy.No. 17159 dated 07-03-2019 Rs.20,000/- Dated
06-03-2019
Pharmacological Group Cephalosporin
Type of Form Form 5
Pack size & Demanded Price 1’s ; As per SRO
Approval status of product in Rocephin I.M injection of (MHRA approved)
Authorities
Me-too status (with strength and Accucef 250 mg IM Injection M/s Wel Wink
GMP status Last GMP inspection of conducted on 16-10-2018
and the report concludes that the panel unanimously
recommend the grant of renewal DML

Evaluator.
Decision: Approved with USP specifications. Registration letter will be issued after
submission of updated GMP status of the firm.
Brand Name +Dosage Form + Cefmark 500mg/Vial I.M Dry Powd
Strength
Ceftriaxone as Sodium…500mg
06-03-2019
Type of Form Form 5
Authorities
Me-too status (with strength and Wixone 500 mg Injection IM M/s Wise
Evaluator.
Brand Name +Dosage Form + Cefmark 1gm/Vial I.M Dry Powd
Strength
Ceftriaxone as Sodium…1gm
06-03-2019
Type of Form Form 5
Authorities
Me-too status (with strength and Accucef 1gm IM Injection M/s Wel Wink

Evaluator.
Brand Name +Dosage Form + Medifik 2% Cream
Strength
Composition Each Gram Contains:
Fusidic Acid…20mg
07-03-2019
Pharmacological Group Anti-bacterial
Type of Form Form-5
Pack size & Demanded Price 5gm, 15gm /As per SRO
Approval status of product in Fucidin of MHRA Approved
Authorities
Me-too status (with strength and Ucid 2% Cream by Ciba Pharma (Reg. No. 081566)
dosage form)
Previous remarks of the • Availability of Cream sections could not be
Evaluator. confirmed.
(Cream sections)
Pakistan
Brand Name +Dosage Form + Seipil ER 330mg Tablet
Strength
Composition Each film coated Extended Release Tablet Contains:
Pregabalin…330mg
06-03-2019
Pharmacological Group Anti-epileptic
Pack size & Demanded Price 10’s, 20’s, 30’s, 60’s, 100’s :As per SRO
Approval status of product in LYRICA CR of USFDA approved
Authorities
Me-too status (with strength and
dosage form) Not found
report concludes that firm is operating at an

acceptable level of cGMP compliance.
Evaluator.
Remarks of the Evaluator. In USFDA description of product as follows:
Decision: Registration Board deferred for submission of stability study data as per the
guidelines provided in 293rd meeting of Registration Board.
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
M/s Swera Pharmaceuticals. (New DML)
CLB in its 282nd meeting held on 31st August 2021 has considered and approved the grant of Drug
Manufacturing License by way of formulation with following six (06) sections to M/s Swera
Pharmaceuticals
1 Tablet(General) 4 Cream/ Gel (General)
2 Capsule (General) 5 Lotion Section (General)
3 Sachet (General) 6 Dry Powder Injection (General)
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Capsule (General)
04 Molecules/ 06 Products
334. Name, address of Applicant / M/s Swera Pharmaceuticals.
Marketing Authorization Holder Plot No. 27, Street No. S-4, National Industrial
Zone, Rawat, Islamabad
Name, address of Manufacturing site. M/s Swera Pharmaceuticals.
Plot No. 27, Street No. S-4 National Industrial
☐ Importer

Details of fee submitted PKR 30,000/-: Deposit Slip No# 64944411
Login 50mg Capsule
brand name
Strength / concentration of drug of Each Capsule Contains:
Active Pharmaceutical ingredient Diclofenac Sodium (as 32% Enteric coated
(API) per unit pellets)…50mg
Pharmaceutical form of applied drug Capsule
Pharmacotherapeutic Group of (API) Non steroidal anti inflammatory Drugs
specifications
Proposed Pack size 2 x 10’s , 3 x 10’s
Difene 50mg Capsules of Ireland approved
authorities
For generic drugs (me-too status) Diclogesic 50mg Capsule by Wilson
Pharmaceuticals Reg. No. 011892
GMP status of the Finished product New DML letter issued dated; 16-09-2021
manufacturer
Name and address of API Vision Pharmaceuticals (pvt) Ltd
manufacturer. Plot3 22-23, Industrial Triangle, Kahutta road,
Islamabad.
drug substance
months
verification studies, batch analysis and justification

comparative dissolution profile against Mobikare 50mg Capsule. By M/s Barret
Hodgson by performing quality tests
(Identification, Assay, and dissolution).
Firm has performed comparative dissolution profile
against the product i.e Mobikare by M/s Barret
Hodgson Batch No# C8862, Pakistan in Acid media
(pH 1.2) & Phosphate Buffer (pH 6.8). and the
results are within acceptable limit
Analytical method Method Validation have submitted including
Manufacturer of API Vision Pharmaceuticals (Pvt) Ltd
Plot# 22-23, Industrial Triangle, Kahutta road, Islamabad.
API Lot No. DE931
Description of Pack
PVC Blistering
Batch No. TB-C001 TB-C002
Batch Size 5000 Capsules 5000 Capsules
Date of Initiation 08-10-2021 08-10-2021
No. of Batches 02
19. Reference of previous approval of New section
the firm (if any)
20. Approval of API/ DML/GMP The firm has submitted copy of GMP certificate
certificate of API manufacturer issued issued by Additional Director DRAP, Islamabad. It
by concerned regulatory authority of is valid till 10-02-2022.
country of origin.
21. Documents for the procurement of API Invoice No # 801689 dated: 16-09-2021 specifying
with approval from DRAP (in case of 2 Kg of Diclofenac sodium 32% EC pellets batch
import). no # DE931
22. Data of stability batches will be Data of stability batches have been submitted by
supported by attested respective UV method along with respective documents like
documents like chromatograms, Raw COA, summary data, sheets.
sheets etc.
23. Compliance Record of HPLC software The firm has performed testing of Login 50mg
21CFR & audit trail reports on product capsule on UV spectrophotometer
testing

temperature and humidity monitoring Submitted
accelerated)
1. 2.3.R.1.1 Quantity of Pellets subject to Assay is done on ‘as is basis’ so there is
assay and moisture content not no need of calculation of moisture
calculated, clarification is content.
required
2. 2.3.R.1.2 Provide blank master production Submitted
document / batch manufacturing
record to be used during the
commercial manufacturing of the
applied product.
3. 3.2.P.2.2.1 Pharmaceutical equivalence of We were unable to arrange the innovator
the applied drug product that’s why we couldn’t perform
shall be established with the Pharmaceutical equivalence against the
innovator product innovator product.
and results of all the quality tests Pharmaceutical equivalence of Login
of the developed formulation and capsules has been performed against
the innovator product shall be Mobikare capsules prepared by Barret
submitted and discussed. Hodgson as per available guidance
document on DRA website i.e
Pharmaceutical equivalence may also be
carried out against reference/comparator
product.
4. 3.2.P.5.2 • Justification is required for • The assay was performed on UV
performing assay testing by Spectrophotometer as the method
UV method instead of HPLC provided by the Diclofenac sodium
method. pellets manufacturer was also on
• Justification is required for UV, moreover complete method
setting dissolution limit in validation has been performed and
phosphate buffer stage as submitted for your kind
NLT 75% in 45 min which is
consideration.
different from that mentioned
in Specifications i.e., NLT • The dissolution time limit is 45
75% in 30 min. minutes, the time 30 minutes is
typographical error.
5. 3.2.P.5.3 Submit protocols of analytical Submitted
method validation.
6. 3.2.P.8 • Documents for the • Submitted
procurement of the API • Submitted
including purchase invoice
from M/s Vision
Pharmaceuticals (Pvt.) Ltd.
chambers (real time and
accelerated)

Decision: The Board deferred the case for scientific justification of performance of assay testing
by using UV-spectrophotometer instead of using HPLC method as performed by the reference
product.
☐ Importer
Emozol 20mg Capsule
brand name
Strength / concentration of drug of Each capsule contains:-
Active Pharmaceutical ingredient Esomeprazole magnesium Trihydrate enteric
(API) per unit coated pellets 22.5% equivalent to .....20mg
Pharmacotherapeutic Group of (API) Proton Pump Inhibitor
USP
specifications
Nexium 20mg Capsule of USFDA approved
authorities
For generic drugs (me-too status) Es0-DEW 20mg Capsule by Dew-maxPharma
Reg. No. 09505
manufacturer
Islamabad.

drug substance
months
comparative dissolution profile against against the brand leader that is Nexum 20mg
Capsules Getz Pharma by performing quality tests
dosage form).
against the Nexum 20mg Capsules by Getz Pharma
in Acid media (pH 1.2) & Phosphate Buffer (pH
range.
specificity.
API Lot No. EMZ046402
Description of Pack
Alu-Alu blister
Batch No. RD-C007 RD-C008
Batch Size 5000 cap 5000 cap

No. of Batches 02
the firm (if any)
country of origin.
with approval from DRAP (in case of 2 Kg of Esomeprazole Magnesium 22.5% EC
import). pellets batch no # EMZ046402
sheets etc.
testing
accelerated)
1. 1.5.2 Revise label claim with salt form In section 1.5.2 there is typographical
with submission of RS: 30000/- error, the same label claim has been
fee. written in correct form as in section:
2.3.P.1
2.3.P.2.2.1
3.2.P.2.2.1 3.2.P.3.5
2. 2.3.R.1.1 • Justify the quantity of Molecular weight of Esomeprazole Mg:
92.46mg of Esomeprazole 713.1
magnesium Pellets 22.5% Molecular weight of Mg: 24.305
equivalent to 20mg of Factor for Mg: 1.035
Esomeprazole. As the pellets contain Esomeprazole Mg
• Salt factor is not adjusted in Label claim for 20mg: 100/22.39
the product development. *20=89.33mg
Justification is required For Mg adjustment multiply the factor of
Mg with 89.33=92.46
Salt factor already adjusted for Mg as

above.
applied product.
4. 3.2.P.1 Justify the quantity of 92.46mg Please refer to the reply of 2.3.R.1.1 as
of Esomeprazole magnesium already discussed above.

Pellets 22.5% equivalent to 20mg
of Esomeprazole
5. 3.2.P.2.2.1 • Justify the quantity of • We were unable to arrange the
92.46mg of Esomeprazole innovator product that’s why we
magnesium Pellets 22.5% couldn’t perform Pharmaceutical
equivalent to 20mg of equivalence against the innovator
Esomeprazole. product.
• Salt factor is not adjusted in
the product development. • Pharmaceutical equivalence of
Justification is required Emozol 20mg capsules has been
performed against Nexum 20mg
capsules prepared by Getz Pharma as
per available guidance document on
dra website i.e Pharmaceutical
equivalence may also be carried out
against reference/comparator
product.
6. 3.2.P.5.2 • For Dissolution which test of • For Dissolution Test 1 was adopted.
USP was adopted.
• In USP dissolution is • Dissolution was performed on HPLC
conducted by HPLC while for raw material i.e pellets and the
Your method is by U.V. same pellets has been used for
Clarification is required. filling, so due to convenience of UV
the dissolution has been performed
on UV as the dissolution of the same
pellets has been performed on HPLC
in case of Raw material. Furthermore
it is committed that Dissolution will
be performed on HPLC in coming
commercial batches.
method validation.
procurement of the API
including purchase invoice • Submitted.
from M/s Vision
accelerated)
• Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in label claim,

• Registration letter will be issued after submission of revised method for dissolution testing
on HPLC method according to USP pharmacopeia monograph and performance of
dissolution testing on HPLC method on next time point.
☐ Importer
Emozol 40mg Capsule
brand name
Strength / concentration of drug of Each capsule contains:-
Active Pharmaceutical ingredient Esomeprazole magnesium Trihydrate enteric
(API) per unit coated pellets 22.5% equivalent to .....40mg
USP
specifications
Nexium 40mg Capsule of USFDA approved
authorities
For generic drugs (me-too status) Eso-Dew 40mg Capsules by M/s Dew-Max
Pharma, Reg. No. 09506
manufacturer
Islamabad.

drug substance
months
comparative dissolution profile against against the brand leader that is Nexum
40mg Capsules Getz Pharma by performing quality
tests (Identification, Assay, Dissolution, Uniformity
of dosage form).
against the Nexum 40mg Capsules by Getz Pharma
in Acid media (pH 1.2) & Phosphate Buffer (pH
range.
specificity.
API Lot No. EMZ046402
Description of Pack
Alu-Alu blister
Batch No. RD-C009 RD-C010 RD-C011
Batch Size 1500 cap 1500 cap 1500 cap

No. of Batches 03
the firm (if any)
country of origin.
with approval from DRAP (in case of 2 Kg of Esomeprazole Magnesium 22.5% EC
import). pellets batch no # EMZ046402
sheets etc.
testing
accelerated)
1. 1.5.2 Revise label claim with salt form In section 1.5.2 there is typographical
with submission of RS: 30000/- error, the same label claim has been
fee. written in correct form as in section:
2.3.P.1
2.3.P.2.2.1
3.2.P.2.2.1 3.2.P.3.5
2. 2.3.R.1.1 • Justify the quantity of Molecular weight of Esomeprazole Mg:
184.920mg of Esomeprazole 713.1
magnesium Pellets 22.5% Molecular weight of Mg: 24.305
equivalent to 40mg of Factor for Mg: 1.035
Esomeprazole. As the pellets contain Esomeprazole Mg
• Salt factor is not adjusted in Label claim for 20mg: 100/22.39
the product development. *40=178.65mg
Justification is required For Mg adjustment multiply the factor of
Mg with 178.65=184.9
Salt factor already adjusted for Mg as

above.
applied product.
4. 3.2.P.1 Justify the quantity of 184.920mg Please refer to the reply of 2.3.R.1.1 as
of Esomeprazole magnesium already discussed above.

Pellets 22.5% equivalent to 40mg
of
Esomeprazole
5. 3.2.P.2.2.1 Pharmaceutical equivalence of • We were unable to arrange the
the applied drug shall be innovator product that’s why we
established with the innovator couldn’t perform Pharmaceutical
product and results of all the equivalence against the innovator
quality tests of the developed product.
formulation and the innovator
product shall be submitted and • Pharmaceutical equivalence of
discussed. Emozol 40mg capsules has been
performed against Nexum 40mg
capsules prepared by Getz Pharma as
per available guidance document on
dra website i.e Pharmaceutical
equivalence may also be carried out
against reference/comparator
product.
6. 3.2.P.5.2 • For Dissolution which test of • For Dissolution Test 1 was adopted.
USP was adopted.
• In USP dissolution is • Dissolution was performed on HPLC
conducted by HPLC while for raw material i.e pellets and the
Your method is by U.V. same pellets has been used for
Clarification is required. filling, so due to convenience of UV
the dissolution has been performed
on UV as the dissolution of the same
pellets has been performed on HPLC
in case of Raw material. Furthermore
it is committed that Dissolution will
be performed on HPLC in coming
commercial batches.
method validation.
procurement of the API • Submitted.
from M/s Vision
accelerated)
• Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in label claim,

• Registration letter will be issued after submission of revised method for dissolution testing
on HPLC method according to USP pharmacopeia monograph and performance of
dissolution testing on HPLC method on next time point.
☐ Importer
Sevodex 30mg Capsule
brand name
Strength / concentration of drug of Each hard gelatin Capsule contains:
Active Pharmaceutical ingredient DDR Pellets of Dexlansoprazole Eq. to
(API) per unit Dexlansoprazole………. 30mg
specifications
Proposed Pack size 3 x 10’s
The status in reference regulatory DEXILANT delayed-release capsules of USFDA
authorities approved
For generic drugs (me-too status) Dexxoo 30mg Capsules by M/s Horizon Pharma,
Reg. No. 088381
manufacturer
Islamabad.

drug substance
months
Firm submitted dissolution of drug product in 3 pH:
Acid stage 0.1N HCl and
Buffer stage pH 5.5 and pH 7.0
Pharmaceutical equivalence and established against the brand leader that is Razodex
comparative dissolution profile 30mg Capsules Getz Pharma by performing quality
of dosage form).
that is Razodex 30mg Capsules by Getz Pharma in
Acid media (pH 1.2) & Phosphate Buffer (pH 7.0).
The values for f1 and f2 are in the acceptable range.
API Lot No. DLP756
Description of Pack
Alu-Alu Blistering

No. of Batches 03
the firm (if any)
country of origin.
with approval from DRAP (in case of 2 Kg of DDR Pellets of Dexlansoprazole 22.5%
import). EC pellets batch no # DLP756
sheets etc.
testing
accelerated)
required
applied product.
the applied drug product that’s why we couldn’t perform
shall be established with the Pharmaceutical equivalence against the
innovator product innovator product.
and results of all the quality tests Pharmaceutical equivalence of Sevodex
of the developed formulation and 30mg capsules has been performed
the innovator product shall be against Razodex 30mg capsules prepared
submitted and discussed. by Getz Pharma as per available guidance
document on dra website i.e
Pharmaceutical equivalence may also be
carried out against reference/comparator
product.
method validation.

from M/s Vision
accelerated)
• The firm will perform Comparatice Dissolution Profile and Pharmaceutical Equivalence
studies against the innovator’s product before issuance of registration letter.
☐ Importer
Sevodex 60mg Capsule
brand name
Active Pharmaceutical ingredient DDR Pellets of Dexlansoprazole Eq. to
(API) per unit Dexlansoprazole………. 60mg
specifications
The status in reference regulatory DEXILANT delayed-release capsules of USFDA

For generic drugs (me-too status) Dexxoo 60mg Capsules by M/s Horizon Pharma,
Reg. No. 088380
manufacturer
Islamabad.
drug substance
months
Firm submitted dissolution of drug product in 3 pH:
Acid stage 0.1N HCl and
Buffer stage pH 5.5 and pH 7.0
Pharmaceutical equivalence and established against the brand leader that is Razodex
comparative dissolution profile 60mg Capsules Getz Pharma by performing quality
of dosage form).
that is Razodex 60mg Capsules by Getz Pharma in
Acid media (pH 1.2) & Phosphate Buffer (pH 7.0).
The values for f1 and f2 are in the acceptable range.

API Lot No. DLP756
Description of Pack
Alu-Alu Blistering
No. of Batches 03
the firm (if any)
country of origin.
with approval from DRAP (in case of 2 Kg of DDR Pellets of Dexlansoprazole 22.5%
import). EC pellets batch no # DLP756
sheets etc.
testing
accelerated)
required
applied product.
the applied drug shall be product that’s why we couldn’t perform

established with the innovator Pharmaceutical equivalence against the
product innovator product.
and results of all the quality tests Pharmaceutical equivalence of Sevodex
of the developed formulation and 60mg capsules has been performed
the innovator product shall be against Razodex 60mg capsules
submitted and discussed. prepared by Getz Pharma as per
available guidance document on dra
website i.e Pharmaceutical equivalence
may also be carried out against
reference/comparator product.
method validation.
from M/s Vision
accelerated)
• The firm will perform Comparatice Dissolution Profile and Pharmaceutical Equivalence
studies against the innovator’s product before issuance of registration letter.
339. Name, address of Applicant / M/s Swera Pharmaceuticals Islamabad
Name, address of Manufacturing site. M/s Swera Pharmaceuticals
Plot 27, Street S-4, Industrial Area Rawat
Islamabad
☐ Importer
Itrora 100mg Capsules
brand name

Active Pharmaceutical ingredient Immediate Release pellets of Itraconazole eq. to
(API) per unit Itraconazole USP ………. 100mg
(Product Specs: USP)
Pharmaceutical form of applied drug White to off white enteric coated pellets filled in
green/white hard gelatin capsule shells
Pharmacotherapeutic Group of (API) Anti-fungal (Triazoles)
USP specs
specifications
The status in reference regulatory Sporanox Capsule of Janseen Pharmaceuticals
authorities Horsham USFDA
For generic drugs (me-too status) ICON 100mg Capsule of M/s Ferozsons,
Nowshehra Reg No: 026877
manufacturer
Name and address of API Vision Pharmaceuticals (Pvt.) Ltd. Plot # 22-23,
manufacturer. Industrial Triangle, Kahutta Road, Islamabad-
Pakistan.
substance and drug product is submitted
Module III (Drug Substance) Monograph of Itraconazole pellets is USP
Monograph. The firm as submitted detail of
months
Batches: (ICZ1465, ICZ1466, ICZ1467)
(including dissolution testing) and its verification

Pharmaceutical equivalence and Pharmaceutical Equivalence has been established
comparative dissolution profile against the Innovator product that is Sporanox
100mg Capsules TM of Janseen Pharmaceutica,
Beerse, Belgium manufactured in Pak by Aspin
Pharma, by performing quality tests (Identification,
Assay, Dissolution and Uniformity of dosage form).
that is Sporanox 100mg Capsules by Aspin Pharma
in Acid media (pH 1.0-1.2) & in media of pH 4.5
& 6.8). The values for f1 and f2 are in the acceptable
range.

Manufacturer of API Vision Pharmaceuticals (Pvt.) Ltd. Plot # 22-23, Industrial Triangle,
Kahutta Road, Islamabad-Pakistan.
API Lot No. ICZ1497
Description of Pack
PVC blister packed in unit carton (1×4’s)
No. of Batches 03
the firm (if any)
country of origin.
with approval from DRAP (in case of 1 Kg of Itraconazole 22% IR pellets batch no #
import). ICZ1497
4. Data of stability batches will be Data of stability batches have been submitted by
supported by attested respective UV method along with respective documents like
documents like chromatograms, Raw COA, summary data, sheets.
sheets etc.

21CFR & audit trail reports on product Manual audit trail report submitted
testing
accelerated)
required
applied product.
3. 3.2.P.5.2 • Justification is required for The dissolution time limit is 45 minutes,
setting dissolution limit in the time 30 minutes is typographical
0.25% W/v SLS in 0.1N HCl error.
as NLT 80% in 45 min which
is different from that
mentioned in Specifications
i.e., NLT 80% in 30 min.
procurement of the API
including purchase invoice • Submitted
from M/s Vision
accelerated)
Decision: Approved with USP specification..
• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
b. New/Additional section(s)
M/s News Pharma Lahore. (New Section)
CLB in its 283rd meeting held on 28th October 2021 has considered and approved the grant One (01)
Additional section to M/s News Pharma Lahore. Accordingly, firm has applied for following products
for consideration by Drug Registration Board.
Oral Liquid General section
09 Molecules/ 10 Products

340. Name, address of Applicant / M/s News Pharma Lahore
Marketing Authorization Holder Plot 42, Sundar Industrial Estate Lahore
Name, address of Manufacturing site. M/s News Pharma
Plot 42, Sundar Industrial Estate Lahore
☐ Importer
Details of fee submitted PKR 30,000/-: dated : 03-03-2022
Newmol 120 mg / 5 mL Suspension
brand name
Strength / concentration of drug of Each 5 mL contains:
Active Pharmaceutical ingredient Paracetamol (BP).... 120 mg
(API) per unit
Pharmaceutical form of applied drug Pink colour sweet homogeneous
strawberry flavored oral suspension
Pharmacotherapeutic Group of (API) Paracetamol is part of the class of drugs known as
"aniline analgesics"
BP
specifications
Proposed Pack size 60 mL, 120 mL, 400 mL
The status in reference regulatory Paracetamol 120 mg/5 ml Oral Suspension by M/s
authorities Pinewood healthcare UK (MHRA Approved)
For generic drugs (me-too status) Febrol 120 mg/5 ml Suspension by Barret
Hodgson
Reg. No. 023532
GMP status of the Finished product New additional section of Oral Liquid general
manufacturer section approved on : 28-10-2021 letter issued on:
12-11-2021 and inspection conducted on: 28-07-
2021
Name and address of API Pharmagen Limited.
manufacturer. 34-Km, Ferozepur Road, Lahore, Pakistan.

Module III (Drug Substance) Official monograph of Paracetamol is present in
BP. The firm as submitted detail of nomenclature,
drug substance
months
comparative dissolution profile against Calpol 120 mg/5 mL Susp. By M/s GSK
by performing quality tests (Identification, Assay,
and determination of Impurity (4-Aminophenol).
CDP – Not applicable
specificity.
Manufacturer of API Pharmagen Limited.
34-Km, Ferozepur Road, Lahore, Pakistan.
API Lot No. 00510921/040/2021
Description of Pack Amber glass bottle sealed with aluminium cap and packed in printed
(Container closure system) unit cartons.
No. of Batches 03

the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP certificate dated 22-05-2019 issued
certificate of API manufacturer issued by DRAP
country of origin.
3. Documents for the procurement of API Local source
import).
sheets etc.
5. Compliance Record of HPLC software Audit Trail submitted
testing
accelerated)
1. 2.3.R.1.1 Manufacturing method mentioned BMR’s, 3.2.P.2.3 and 3.2.P.3.5. have
and in BMR’s is not same as been revised and same method is
2.3.R.1.1 mentioned in section 3.2.P.2.3 adopted. Documents attached
and 3.2.P.3.5. Clarification is
required
2. 3.2.S.4.2 • Analytical procedures used • Analytical Procedures used for
for routine testing of the Drug routine testing of the drug substance /
substance /Active Active Pharmaceutical Ingredient by
Pharmaceutical Ingredient by Drug Substance are attached.
Drug substance is required.
• Submitted assay method is • It is a typographical mistake. Actual
different than B.P monograph. method is submitted.
3. 3.2.S.4.3 In B.P and as per your , method Revised Verification studies were
Assay is carried out by titration conducted by titration method. Copy of
method while Verification studies reports is attached.
are conducted by HPLC.
4. 3.2.P.2.5 Preservative effectiveness studies Preservative effectiveness studies
to be performed as per performed as per recommendations of
recommendations of Pharmacopoeia.
pharmacopoeia) shall be provided
5. 3.2.P.5.4 The copies of complete analysis The copies of complete analysis of at
of at least two batches shall be least two batches.
provided.

☐ Importer
Details of fee submitted PKR 30,000/-: dated : 03-03-2022
Newmol 6 Plus 250 mg / 5 mL Suspension
brand name
Active Pharmaceutical ingredient Paracetamol (BP).... 250 mg
(API) per unit
Pharmaceutical form of applied drug Pink colour sweet homogeneous
strawberry flavored oral suspension
Pharmacotherapeutic Group of (API) Paracetamol is part of the class of drugs known as
"aniline analgesics"
BP
specifications
Proposed Pack size 60 mL, 120 mL, 400 mL
The status in reference regulatory Paracetamol 250 mg/5 ml Oral Suspension by M/s
authorities Pinewood healthcare UK (MHRA Approved)
For generic drugs (me-too status) Febrol 250 mg/5 ml Suspension by Barret
Hodgson
Reg. No. 023533
2021
Name and address of API Pharmagen Limited.
manufacturer. 34-Km, Ferozepur Road, Lahore, Pakistan.

Module III (Drug Substance) Official monograph of Paracetamol is present in
BP. The firm as submitted detail of nomenclature,
drug substance
months
comparative dissolution profile against Calpol 6 Plus 250 mg/5 mL Susp. By M/s
GSK by performing quality tests (Identification,
Assay, and determination of Impurity (4-
Aminophenol).
specificity.
Manufacturer of API Pharmagen Limited.
34-Km, Ferozepur Road, Lahore, Pakistan.
API Lot No. 00510921/040/2021

No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP certificate dated 22-05-2019 issued
certificate of API manufacturer issued by DRAP
country of origin.
3. Documents for the procurement of API Local source
import).
sheets etc.
5. Compliance Record of HPLC software Audit Trail submitted
testing
accelerated)
1. 2.3.R.1.1 • Manufacturing method • BMR’s, 3.2.P.2.3 and 3.2.P.3.5. have
mentioned in BMR’s is not been revised and same method is
same mentioned in adopted. Documents attached.
section 3.2.P.2.3 and • No overage was added in the
3.2.P.3.5. Clarification is formulation. There was human error
required. in calculation of material which has
• Justification of overages in been corrected in BMR’s attached.
the formulation(s) shall be • Actual batch size is 45 bottles
submitted. according to which all calculations
• Batch size 100 bottles done. 100 bottles was mentioned by
mentioned while in stability clerical mistake.
sheets and COA’s 45 bottles
mentioned.
2. 2.3.R.1.2 • Manufacturing method BMR’s, 3.2.P.2.3 and 3.2.P.3.5. have
mentioned in BMR’s is not been revised and same method is
same mentioned in adopted. Documents attached.
section 3.2.P.2.3 and
3.2.P.3.5. Clarification is
required
3. 3.2.S.4.2 • Analytical procedures used • Analytical Procedures used for
for routine testing of the Drug routine testing of the drug substance /
substance /Active Active Pharmaceutical Ingredient by
Drug Substance are attached.

Pharmaceutical Ingredient by • It is a typographical mistake. Actual
Drug substance is required. method is submitted.
• Submitted assay method is
different than B.P
monograph. Clarification is
required.
4. 3.2.S.4.3 In B.P and as per your ,method Revised Verification studies were
Assay is carried out by titration conducted by titration method. Copy of
method while Verification studies reports is attached.
are conducted by HPLC.
5. 3.2.P.2.2.2 Justification of overages in the No overage was added in the formulation.
formulation(s) shall be submitted. There was human error in calculation of
material which has been corrected in
BMR’s attached.
recommendations of Pharmacopoeia.
7. 3.2.P.5.4 The copies of complete analysis The copies of complete analysis of at
of at least two batches shall be least two batches.
provided.
• Registration letter will be issued after submission of Pharmaceutical Equivalence with
Innovator product.
☐ Importer
Newzine 5mg/5ml oral solution
brand name
Active Pharmaceutical ingredient Cetirizine Dihydrochloride…..5 mg
(API) per unit

Pharmaceutical form of applied drug Clear & transparent, sweet with characteric flavor oral
solution filled in 60 mL amber pet bottle sealed with
pilfer proof aluminium caps
Pharmacotherapeutic Group of (API) Anti-histamine
BP
specifications
Proposed Pack size 1 ×60 mL, 1 x 400 mL
The status in reference regulatory Zirtek Allergy Solution 1 mg/ml oral solution by
authorities M/s UCB Pharma, MHRA Approved.
For generic drugs (me-too status) Avec 5 mg/ 5 mL oral solution by M/s Platinum
2021
Name and address of API Karunesh Remedies
manufacturer. Plot # 417/2, Phase-II, G.I.D.C.,
Estate Panoli-394116. Ta. Ankleshwar,
District Bharuch, Gujarat (India)
Module III (Drug Substance) Official monograph of Cetirizine Dihydrochloride
is present in BP. The firm as submitted detail of
Identification, Assay and tests for related
substances (impurity A, B, C, D, E,F & unspecified
and total impurities), specifications, analytical
drug substance
months
months
Batches:(SLL/CTR/0309047, SLL/CTR/0309048,
SLL/CTR/0309047)

product.
comparative dissolution profile against the brand leader that is Zyrtec oral solution
by GSK Pharma by performing quality tests
(Identification, Assay, pH, Uniformity of dosage
form & related substances).
specificity.
Manufacturer of API Karunesh Remedies
Plot # 417/2, Phase-II, G.I.D.C.,
Estate Panoli-394116. Ta. Ankleshwar,
District Bharuch, Gujarat (India)
API Lot No. CTZ/028/21-22
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No.S-GMP-20102293
certificate of API manufacturer issued issued by Food and Drug Administration (Gujrat
by concerned regulatory authority of Estate) India valid till 25/10/2022.
country of origin.
3. Documents for the procurement of Copy of letter No.14901/2021/DRAP-AD-
API with approval from DRAP (in CD(I&E) dated 04/10/2021 is submitted wherein
case of import). the permission to import different APIs including
Cetirizine Dihydrochloride for the purpose of
test/analysis and stability studies is granted.
Firm has submitted copy of Form 3, form 7 &
invoice (invoice# EXP/80(20-21) specifying
import 1Kg Cetirizine Dihydrochloride (Batch#

CTZ/028/21-22).However not attested by DRAP.
Copy of DHL is provided.
sheets etc.
5. Compliance Record of HPLC Audit Trail submitted
on product testing
accelerated)
1. 2.3.R.1.1 Manufacturing method mentioned Short method was mentioned in BMR.
in BMR’s is not same as Now Revise BMR (s) are submitted as
mentioned in section 3.2.P.2.3 with detailed method as mentioned in
and 3.2.P.3.5. Clarification is 3.2.P.2.3 and 3.2.P.3.5
required
2. 2.3.R.1.2 Provide blank master production Blank Batch Manufacturing Record is
document / batch manufacturing attached
applied product
3. 3.2.S.4.2 Analytical procedures used for Analytical Procedures used for routine
routine testing of the Drug testing of the drug substance / Active
substance /Active Pharmaceutical Pharmaceutical Ingredient by Drug
Ingredient by Drug substance is Substance is attached.
required.
4. 3.2.S.4.3 In analytical method verifications It is clarified that 0.1M Sodium Nitrite
in accuracy Volume of 0.1M is a typing mistake, 0.1M Sodium
Sodium nitrile used mentioned Hydroxide is correct
while in assay 0.1M Sodium
Hydroxide used. Clarification is
required.
recommendations of pharmacopoeia) is provided.
6. 3.2.P.5.4 Batch size mentioned in this It is clarified that actual batch size is 45
section is 100 bottles while in bottles and in 3.2.P.5.4 100 bottles
section 3.2.P.8 mentioned as 45 mentioned mistakenly. Revised COA (s)
bottles. Clarification is required. are attached
7. 3.2.P.8 Commercial invoice with Copy of DHL is provided.
approval from DRAP. Calculations of Assay.
Submit Calculations of Assay
with details of dilutions.

☐ Importer
Newzol 200 mg / 5 mL Suspension
brand name
Strength / concentration of drug of Each 5 mL suspension contains:
Active Pharmaceutical ingredient Metronidazole Benzoate eq to Metronidazole ....
(API) per unit 200 mg
Pharmaceutical form of applied drug Liquid suspension filled in amber glass bottle sealed
with pilfer proof aluminium caps.
Pharmacotherapeutic Group of (API) Anti-Protozoal (Antimicrobial)
BP Specs.
specifications
Proposed Pack size 60 mL , 120 mL, 400 mL
The status in reference regulatory Metronidazole 200mg/5ml Oral Suspension by
authorities Rosemont House, York dale Industrial Park,
Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Approved by MHRA
For generic drugs (me-too status) Diagyl 200 mg/5 ml Suspension by M/S Swiss
Pharma , Reg. No. 020229
2021
Name and address of API M/S Hubei Hongyuan Pharmaceutical
manufacturer. Technology Co., Ltd.
Address: No. 126, Dabieshan Aveneu, Economic
Development Zone, Luotian, Hubei, China.

stability studies of drug substance
months
months
Batches: (MTZ/001/2015, MTZ/002/2015,
MTZ/003/2015)
product.
Pharmaceutical equivalence and The Firm has performed pharmaceutical
comparative dissolution profile equivalence of the developed formulation Newzol
Suspension 200 mg/5mL with brand leader product
Flagyl 200 mg/5ml Susp. (Sanofi-Aventis).
specificity.
Manufacturer of API M/S Hubei Hongyuan Pharmaceutical Technology Co., Ltd.
Address: No. 126, Dabieshan Aveneu, Economic Development Zone,
Luotian, Hubei, China.
API Lot No. 02120190993
Description of Pack Oral Suspension filled in amber glass bottle sealed with pilfer proof
(Container closure system) aluminium
caps.

No. of Batches 03
2. Approval of API/ DML/GMP The firm has submitted copy of GMP Certificate #
certificate of API manufacturer issued HB20180424 for M/S Hubei Hongyuan
by concerned regulatory authority of Pharmaceutical Technology Co., Ltd. issued by
country of origin. China Food and Drug administration. It is valid
till 03-07-2023.
Metronidazole Benzoate for the purpose of
Firm has submitted copy of Form 3,form 7 &
invoice (invoice# EXP/0109SLT2110(20-21)
dated: 05-09-2021 specifying import 1Kg
Metronidazole Benzoate (Batch# 02120190993).
However not attested by DRAP. Copy of DHL is
provided.
sheets etc.
on product testing
accelerated)
1. 2.3.R.1.1 • Manufacturing method Short method was mentioned in BMR.
mentioned in BMR’s is not Now Revise BMR (s) & 3.2.P.2.3 are
same as mentioned in submitted as with detailed method as
section 3.2.P.2.3 and mentioned in 3.2.P.3.5
3.2.P.3.5. Clarification is It is clarified that actual batch size is 45
bottles and 100 bottles mentioned
required.
mistakenly.
• Batch size mentioned is 100
bottles while in 3.2.P.5.4 and
3.2.P.8 batch size mentioned
is 45 bottles mentioned .
in BMR’s is not same as Now Revise BMR is submitted with

mentioned in section 3.2.P.2.3 detailed method as mentioned in
required
3. 3.2.S.4.2 Analytical procedures used for Analytical procedures used for routine
routine testing of the Drug testing of the Drug substance /Active
Ingredient by Drug substance is substance is attached.
required
4. 3.2.S.4.3 In B.P and as per your ,method It is clarified that Titration method is
Assay is carried out by titration used for Verification studies. Revised
method while Verification studies Verification reports with Titration
are conducted by HPLC. method is attached.
6. 3.2.P.5.1 In B.P monograph test for Revised reports including test of
metronidazole included which is metronidazole are attached
not performed. Clarification is
required.
7. 3.2.P.5.3 Submit protocols for analytical Protocols for analytical method
method verifications. verifications are submitted.
8. 3.2.P.6 COA of metronidazole reference COA of Metronidazole reference
standard including source and lot standard including source and lot
number shall be provided number is attached.
☐ Importer

Newsal Oral Solution 2 mg / 5 mL
brand name
Active Pharmaceutical ingredient Salbutamol (as Sulphate).... 2mg
(API) per unit
Pharmaceutical form of applied drug Oral solution filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Β2-Agonist
B.P Specs.
specifications
Proposed Pack size 60 mL, 120mL, 400 mL
The status in reference regulatory Salbutamol syrup 2mg/5ml by M/S Pinewood
authorities Healthcare
Approved by MHRA
For generic drugs (me-too status) Ventolin 2 mg/ 5mL M/s GSK, Reg. No. 000287
2021
Name and address of API M/S Vamsi Labs Ltd.
manufacturer. Address: A-14/15,M.I.D.C.area,, CHINCHOLL,
SOLAPUR, DIST- SOLAPUR, INDIA
months
months
Batches: (SS-0010610, SS-0020610&SS-
0030610)

product.
comparative dissolution profile equivalence of their developed formulation Newsal
Syrup with brand leader product Ventolin Syrup of
M/s GSK
specificity.
Manufacturer of API M/S Vamsi Labs Ltd.
Address: A-14/15,M.I.D.C.area,, CHINCHOLL, SOLAPUR-413255,
DIST- SOLAPUR, INDIA
API Lot No. SS-0070721
Description of Pack Oral solution filled in amber glass bottle sealed with pilfer proof
caps.
No. of Batches 03
2. Approval of API/ DML/GMP The firm has submitted copy of GMP Certificate
certificate of API manufacturer issued No # 6100529 for M/s Vamsi Labs. Ltd, India
by concerned regulatory authority of issued by food and drugs administration
country of origin. (Maharashtra State) India. It is valid till 07-07-
2022.
Salbutamol Sulphate for the purpose of
invoice (invoice# EXP/VAM/186 dated: 06-09-
2021 specifying import 1Kg Salbutamol Sulphate

(Batch# SS-0070721 ). However not attested by
DRAP. Copy of DHL is provided.
sheets etc.
on product testing
accelerated)
required.
mistakenly.
• Batch size mentioned is 100
bottles while in 3.2.P.5.4 and
3.2.P.8 45 bottles mentioned .
required
required
4. 3.2.S.4.3 In verification studies Sodium Titration is performed with 01M
hydroxide and sodium nitrile Perchloric acid and not with sodium
mentioned. Clarification is hydroxide or sodium nitrile.
required.
5. 3.2.P.2.5 Preservative effectiveness studies Preservative effectiveness studies to be
6. 3.2.P.5.3 Submit protocols for analytical Protocols for analytical method
method verifications. verifications are submitted

☐ Importer
Newdom Suspension 5mg/5ml.
brand name
Strength / concentration of drug of Each 5 ml Suspension contains:
Active Pharmaceutical ingredient Domperidone ……..5 mg
(API) per unit
Pharmaceutical form of applied drug Oral suspension filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Dopamine Antagonist
specifications Innovator’s
Proposed Pack size 60 ml, 90 mL, 120 mL & 400 mL

The status in reference regulatory Domperidone 1 mg/mL Suspension. MHRA
For generic drugs (me-too status) Motilium Suspension 5 mg /5 mL Reg # 006527
2021
Name and address of API M/S Vasudha Pharma Chem Limited.
manufacturer. Address: Unit-II, Plot No. 79Jawaharlal Nehru
Pharma City Thanam(V), Parawada(M),
Visakhapatnam District-531019, Andhra Pradesh,
India.

months
months
Batches: (DN-01T15, DN-02T15, DN-03T15)
product.
comparative dissolution profile equivalence of their developed formulation
Newdom Suspension with comparator product
Motilium Susp. 5 mg/5ml Susp. By M/s Aspin
Pharma.
specificity.
Manufacturer of API M/S Vasudha Pharma Chem Limited
Unit-II, Plot No. 79 Jawaharlal Nehru Pharma City Thanam (V),
Parawada(M), Visakhapatnam District-531019, Andhra Pradesh,
India.
API Lot No. EDOM/2110097
Description of Pack Oral Suspension filled in Amber glass bottle sealed with pilfer proof
(Container closure system) aluminium caps.

No. of Batches 03
certificate of API manufacturer issued for M/s
by concerned regulatory authority of Vasudha Pharma Chem Ltd, India issued by food
country of origin. and drugs administration (Andhra Pradesh) India.
It is valid till 20-11-2022.
Domperidone for the purpose of test/analysis and
invoice (invoice# EXP/6994 (20-21) dated: 06-09-
2021 specifying import 1Kg Domperidone
(Batch# EDOM/2110097). However not attested
by DRAP. Copy of DHL is provided.
sheets etc.
5. Compliance Record of HPLC Submitted
on product testing
accelerated)
required.
mistakenly.

required

required
4. 3.2.S.4.3 Verification studies are conducted Revised verification reports are attached
by HPLC while assay method is conducted by Titrimetry.
by titrimetry. Clarification is
required.
5. 3.2.S.4.4 Specification claimed are USP Domperidone is not present in USP .
while it is not available in USP. USP was mentioned by mistakenly.
7. 3.2.P.5.1 Specification claimed are B.P. The product is not available in any
Provide evidence of B.P pharmacopeia and B.P is mentioned by
specifications. mistake.
8. 3.2.P.5.2 Justification is required for The product is not available in any
performing assay testing by UV pharmacopeia so we have test from in-
method house testing method. The validation of
testing method is attached in Dossier.
approval from DRAP.. Calculations of Assay.
☐ Importer
New-tran Paediatric Suspension
brand name
Strength / concentration of drug of Each 5 mL suspension contains:
Active Pharmaceutical ingredient Trimethprim ..................... 40 mg
(API) per unit Sulfamethoxazole ............... 200 mg

Pharmaceutical form of applied drug Clear sweet strawberry flavored homogeneous oral
suspension filled in amber glass bottle sealed
with aluminium cap.
BP
specifications
Proposed Pack size 50 mL, 400 ml
The status in reference regulatory Bactrim Suspension by M/S Sun Pharm industries,
For generic drugs (me-too status) Septran Paediatric Suspension by M/s GSK
Pharma Reg. No. 000384
2021
Name and address of API Shouguang Fukang Pharmaceutical company Ltd.
manufacturer. North-East of Dongwaihuan Road, Dongcheng
Industrial Area, Shouguang City, Shandong
Province, People’s Republic of China
Module III (Drug Substance) Official monograph of Trimethoprim and
Sulfamethoxazole is present in BP.
Trimethoprim:
The firm as submitted detail of nomenclature,
process and controls, Identification, Assay and
tests for related substances, impurity K, heavy
metals, specifications, analytical procedures and its
Sulfamethoxazole:
The firm as submitted detail of nomenclature,
process and controls, Identification, Assay and
tests for related substances (impurities A, C, D, E)
& impurity B, impurity F, unspecified impurities
and total impurities, specifications, analytical

drug substance
months
months
Batches of Trimethoprim:
(201103504,201103505, 201103506)
Batches of Sulfamethoxazole:
Accelerated: (200604001,200604002, 200604003
Real Time: (2007706001, 2007706002,
2007706003))
product.
Pharmaceutical equivalence and Pharmaceutical Equivalence has been established
comparative dissolution profile against the brand leader that is Septran Paediatric
Suspension by GSK Pharma by performing quality
tests (Identification, Assay, pH, Uniformity of
dosage unit).
specificity.
Manufacturer of API Shouguang Fukang Pharmaceutical company Ltd.
Shouguang City, Shandong Province, People’s Republic of China
API Lot No. Trimethoprim = A-50112007004-0500
Sulfamethoxazole = A-50212005029
No. of Batches 03

2. Approval of API/ DML/GMP Copy of GMP certificate No. SD 20190888 issued
certificate of API manufacturer issued by China Food and Drug Administration valid till
by concerned regulatory authority of 12/03/2024.
country of origin.
Trimethoprim & Sulfamethoxazole for the
purpose of test/analysis and stability studies is
granted.
21FK08Z814M dated: 12-08-2021 specifying
import 1Kg Sulfamethoxazle (Batch# A-
50212005029) and 0.50 Kg of Trimethoprim
(Batch# A-50112007004-0500). However not
attested by DRAP. Copy of DHL is provided.
sheets etc.
5. Compliance Record of HPLC The firm has performed testing on UV
software 21CFR & audit trail reports Spectrophotometer
on product testing
accelerated)
1. 1.6.5 Valid Drug Manufacturing GMP Certificate is attached.
License issued by the relevant
regulatory authority of country of
origin. or Valid Good
Manufacturing Practice (GMP)
certificate of the Drug Substance
manufacturer issued by relevant
regulatory authority of country of
origin.
routine testing of the both Drug testing of the drug substance / Active
Ingredient (Trimethoprim & Substance is attached.
Sulfamethoxazole) by Drug
substance is required

4. 3.2.P.8 • Commercial invoice with • Copy of DHL is provided.
approval from DRAP. • Actual batch size is 45 bottles for
• Batch size mentioned is 45 each batch. 100 bottles is mentioned
bottles while in 3.2.P.5.4 and by typographic mistake.
in BMR’s 100 bottles
mentioned.
☐ Importer
Newfate 1 g / 10 mL Suspension
brand name
Active Pharmaceutical ingredient Sucralfate ….....1 g
(API) per unit
Pharmaceutical form of applied drug Liquid suspension filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Cytoprotective agent (Drugs for Peptic Ulcer and
Gastro-Oesophageal Reflux Disease -GORD)
ATC Code: A02BX02
Innovator’s Specs.
specifications
The status in reference regulatory Carafate 1 g / 10 mL Suspension by M/s Allergan
authorities Pharmaceuticals Approved by USFDA
For generic drugs (me-too status) Ulsanic 500 mg/5 ml Suspension M/s Highnoon

2021
Name and address of API M/S Northeast Pharmaceutical group Co. Ltd. No.
manufacturer. 29 Shenxiliu dong road, Economic Technological
Development District SHENGYANG. P.R.
CHINA
months
months
Batches: (DY0011500185, DY0011500186 &
DY0011500187)
product.
comparative dissolution profile equivalence of their developed formulation New-
fate Suspension with comparator product Ulsanic
Suspension of Highnoon Laboratories.
specificity.
Manufacturer of API M/S Northeast Pharmaceutical group Co. Ltd. No. 29 Shenxiliu dong
road, Economic Technological Development District SHENGYANG.
P.R. CHINA.

API Lot No. DY0011900195
Description of Pack Oral Suspension filled in amber glass bottle sealed with pilfer proof
caps.
No. of Batches 03
certificate of API manufacturer issued No # LN20190041 for M/S Northeast
by concerned regulatory authority of Pharmaceutical group Co. Ltd. No. 29 Shenxiliu
country of origin. dong road, Economic Technological Development
District SHENGYANG. P.R. CHINA issued by
China Food and Drug administration. It is valid
till 15-07-2024.
Sucralfate USP for the purpose of test/analysis and
Firm has submitted copy of Form 3,form 7 &
invoice (invoice# EXP/71221(20-21) dated: 06-
09-2021 specifying import 400g Sucralfate USP
(Batch# DY0011900195) however not attested by
DRAP. Copy of DHL provided.
sheets etc.
5. Compliance Record of HPLC UV method was used.
on product testing
accelerated)

1. 3.2.S.4.2 • Analytical procedures used • Analytical procedures used for
for routine testing of the routine testing of the Drug substance
Drug substance /Active /Active Pharmaceutical Ingredient by
Pharmaceutical Ingredient by Drug substance are attached.
Drug substance is required.
• Specification claimed USP • It is clarified that USP monograph
while Submitted analytical has been used for routine testing of
procedures used for routine drug substance.
testing of the Drug substance
/Active Pharmaceutical
Ingredient by Drug product
manufacturer are according
to B.P. Clarify which
monograph have been used
among USP or B.P
Pharmacopeia monograph for
drug substance.
2. 3.2.S.4.3 If USP Pharmacopeia followed Analytical verification of Sucrose
than Analytical verification of Octasulfate by drug product
sucrose octasulfate by drug manufacturer is attached.
product manufacturer should be
submitted.
If B.P pharmacopeia followed
than Analytical verification of
sucrose octasulfate and
aluminium by drug product
manufacturer should be
submitted
3. 3.2.S.5 Reference standard according to COA of Potassium Sucrose Octasulfate
USP and B.P is Potassium is attached.
sucrose octasulfate while
submitted COA of working
standard of Sucralfate USP.
4. 3.2.P.2.2.1 • Pharmaceutical equivalence • Pharmaceutical Equivalence had
of the applied drug shall be been performed with market brand
established with the leader as Innovator product is not
innovator product and results available in the country. I had be
of all the quality tests of the done according to
developed formulation and WHO_TRS_902_ANNEX11 report
the innovator product shall be
which is attached
submitted and discussed.
• B.P specification mentioned • Actual Specification is Innovator, BP
in Pharmaceutical mentioned mistakenly.
equivalence . Clarification is
required.
pharmacopoeia) shall be
provided
6. 3.2.P.5.2 • In assay Content of • Revised method is attached
Aluminium and sucrose
octasulfate separate are not • Due to non-Pharmacopeial product,
in-house method had been developed

detected. Clarification should on UV. Method validation is
be submitted in this regard. provided in 3.2. P.5.3.
• In Monograph of Drug
substance assay is conducted
by HPLC while drug product
assay was conducted by U.V.
Clarification is required from
where you have adopted U.V
method for assay.
7. 3.2.P.5.3 Analytical method validation of Analytical method validation of sucrose

sucrose octasulfate not octasulfate is attached.
conducted. Clarification is
required
8. 3.2.P.8 Commercial invoice with Copy of DHL provided.
approval from DRAP.
Decision: Registration Board deferred the case for following:
• Justification of assay of drug product conducted by UV method while drug substance
assay is conducted by HPLC as per USP monograph.
• Performance of assay of drug product as per Revised method.
☐ Importer
The proposed proprietary name / Newfer Syrup 50 mg/5mL
brand name
Strength / concentration of drug of Each 5ml contains:
Active Pharmaceutical ingredient Iron (III) Hydroxide Polymaltose Complex Eq. to
(API) per unit Elemental Iron -----50 mg
Folic Acid ……….. 0.35mg
Pharmaceutical form of applied drug Liquid Syrup filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Iron Supplement
Innovator’s Specs.
specifications

………
authorities
For generic drugs (me-too status) Ferosoft-FA Syrup by M/S Hilton Pharma , Reg.
No. 045110
2021
Name and address of API Iron Polymaltose Complex: Chemiworld Pvt.
manufacturer. Ltd. Plot No. 97, J- Industrial Estate Jamrud
Peshawar Pakistan.
Folic Acid: Hebei Jiheng Pharmaceutical Co.,
Ltd, 1 Weiwu Street, Hengshui City, Hebei
Province, P.R. China 053000
stability studies of both drug substances (i.e. Iron
Polymaltose Complex and Folic acid).
months
months
Batches of Iron Polymaltose Complex : (BPS-
0405118, BPS-0405119, BPS-0405120)
Folic acid : (021702001, 021702002, 021702003)
its
development,

comparative dissolution profile equivalence of the developed formulation Newfer
Syrup 50 mg/5mL with comparator product
Ferosoft-FA Syrup by Hilton Pharma.
specificity.
Manufacturer of API Iron Polymaltose Complex: Chemiworld Pvt. Ltd. Plot No. 97, J-
Industrial Estate Jamrud Peshawar Pakistan.
Folic Acid: Hebei Jiheng Pharmaceutical Co., Ltd, 1 Weiwu Street,
Hengshui City, Hebei Province, P.R. China 053000
API Lot No. Iron Polymaltose Complex: K20-IPC-420
Folic Acid: 022004010
No. of Batches 03
2. Approval of API/ DML/GMP IPC: The firm has submitted copy of GMP
certificate of API manufacturer issued Certificate # F.3-20/2017-DRAP-90 on the basis
by concerned regulatory authority of of inspection conducted on 29-11-2016 for M/S
country of origin. Chemiworld Pvt. Ltd. issued by DRAP. The firm
has submitted application for issuance of new
GMP certificate.
Folic Acid : Copy of GMP certificate No.
HE20170030 issued by China Food and Drug
Administration valid till 26/05/2022.
case of import). the permission to import different APIs Folic acid
for the purpose of test/analysis and stability
studies is granted.
invoice (invoice# HJG/EXP/0124) dated: 07-09-

2021 specifying import 100g Folic acid (Batch#
022004010) however not attested by DRAP. Copy
of DHL provided.
sheets etc.
5. Compliance Record of HPLC UV method used
on product testing
accelerated)
1. 1.6.5 Valid Good Manufacturing Firm submitted copy of request to
Practice (GMP) certificate of the federal inspector of Drugs, Peshawar for
Drug Substance manufacturer issuance of GMP certificate.
authority of country of origin for
Iron Polymaltose Complex.
2. 3.2.S.4.1 Drug substance manufacturer and It is clarified that Iron Polymaltose
Drug product manufacturer did Complex is not present in any
not mentioned Which Pharmacopeia and manufacturer has
specifications followed for Iron developed an in-house method. Drug
Polymaltose Complex. Please Product manufacturer also followed the
clarify. Drug Substance manufacturer’s method
for testing
routine testing of the both Drug testing of the drug substance / Active
Ingredient (Iron Polymaltose Substance is attached.
Complex &Folic Acid) by Drug
substance is required
4. 3.2.S.4.3 • In analytical method • It is clarified that sodium nitrile is a
verification of Iron clerical mistake.
polymaltose complex Sodium • Analytical verification according to
nitrile mentioned . analytical testing method of Iron
clarification is required. Polymaltose Complex. Is attached.
• Submit analytical method
• Revised Verification by HPLC is
verification according to
attached.
analytical testing method of
Iron polymaltose complex
• Analytical verification is done
by titration while analytical
testing method of folic acid is
by HPLC. Clarification is
required.

6. 3.2.P.5.1 Specifications claimed are B.P. Revised specification with in-house
provide evidence. specs is attached.
7. 3.2.P.5.2 • Clarification is required that • The Product is not available in any
how drug product analytical Pharmacopeia we have test the
testing method developed. product with in-house testing
• In Drug substance Iron method. The standard & sample
polymaltose complex assay of solutions scan on UV
iron contents and polymaltose Spectrophotometer pick absorbance
contents are separately on maximum nm. After scanning this
conducted. While in your
solution we have scan sample
analytical testing method
solution placebo for the conformation
assay of Iron polymaltose is
conducted. Justify how of method absorbance and
quantity of elemental Iron is wavelength.
equivalent to 50mg deducted. • In Drug substance iron Polymaltose
complex assay of iron contents and
Polymaltose contents are separately
conducted but in syrup have many
other excipients which disturbed in
testing so that we use factor
calculation for the equivalence of
Iron Polymaltose complex to iron.
1mg of Iron is equivalent to
1.1243mg of Iron Polymaltose
complex
8. 3.2.P.8 •Purchase documents for iron • Iron Polymaltose Complex was
hydroxide polymaltose purchased locally.
• Commercial invoice with • Copy of DHL is provided.
approval from DRAP.
Decision: The Board deferred the case for scientific justification of performance of assay testing
by using UV-spectrophotometer instead of using potentiometric titration or atomic absorption
spectrophotometer.
☐ Importer
New-Deslor Syrup 2.5 mg / 5 mL
brand name

Strength / concentration of drug of Each mL contains:
Active Pharmaceutical ingredient Desloratadine .... 0.5 mg
(API) per unit
Pharmaceutical form of applied drug Oral solution filled in amber glass bottle sealed
Pharmacotherapeutic Group of (API) Anti-histamine
Inhouse
specifications
Proposed Pack size 60 mL / 120 mL
The status in reference regulatory New-Clarityn by Merck Sharp and Dhome Ltd.
authorities Approved by AEPMS (Spanish Agency for
Medicine and Health Products.)
For generic drugs (me-too status) Desora 0.5 mg/mL M/s Continental Pharma,
Reg. No. 055192
GMP status of the Finished product New Section granted on 12/11/2021
manufacturer Oral Liquid General Section approved.
Name and address of API M/s Morepen Laboratories Ltd.
manufacturer. Address: Village-Masulkhana, Parwanoo, District,
Solan, India
procedures
drug substance and drug product is submitted
months
months
Batches: (DH-1501, DH-1502, DH-1503)
its
development,

comparative dissolution profile equivalence of their developed formulation New-
Deslor Syrup with comparator product Clarinex
Syrup of M/s Merck & Co.
specificity.
Manufacturer of API M/s M/s Morepen Laboratories Ltd. Village-Masulkhana, Parwanoo,
Distt.
Solan India.
API Lot No. DH-0106
Description of Pack Oral solution filled in amber glass bottle sealed with pilfer proof
No. of Batches 03
certificate of API manufacturer issued for M/s
by concerned regulatory authority of Morepen Laboratories Ltd, India issued by State
country of origin. Drugs
Controller, Controlling cum Licensing Authority,
Baddi,
District Solan. It is valid till 30-04-2022.
case of import). the permission to import different APIs Folic acid
studies is granted.

invoice (invoice# MME202100508) dated: 14-09-
2021 specifying import 0.5Kg Desloratadine
(Batch# DH-0106).
sheets etc.
software 21CFR & audit trail reports Manual audit trail report submitted
on product testing
accelerated)
and 3.2.P.3.5. Clarification is 3.2.P.2.3 and 3.2.P.3.5.
required.
required
7. 3.2.S.4.3 Testing method of desloratadine Revised verification by HPLC method is
is by HPLC while verification is submitted
done by U.V method.
8. 3.2.S.7 Accelerated stability studies of Accelerated stability studies of drug
drug substance not submitted. substance submitted.
recommendations of pharmacopoeia are provided
10. 3.2.P.5.1 Specifications claimed for drug Revised Specification are attached
product are B.P. provide (Inhouse)
evidence.
11. 3.2.P.5.2 Justification is required for The Product is not available in any
performing assay testing by UV pharmacopeia so we have test from
method inhouse testing method. The validation of
testing method is attached in dossier
12. 3.2.P.8Commercial invoice with Copy of DHL provided.
approval from DRAP.
Decision: Registration Board deferred the case for Justification of assay of drug product
conducted by UV method while drug substance assay is conducted by HPLC as per BP
monograph.
M/s Hudson Pharma Private Limited, Karachi (New Section)

CLB in its 283rd meeting held on 28th October 2021 has considered and approved the grant Two (02)
Additional section/Revised Section to M/s Hudson Pharma Karachi.
Sr.No Name of Section
1. Injection Ampoule BF (Steroid)
2. Capsule (General) Section
Injection Ampoule BF (Steroid)
02 Molecules/02 Products
350. Name, address of Applicant / M/s Hudson Pharma Private Limited
Marketing Authorization Holder D-93, North Western Industrial Zone,
Port Qasim, Karachi, Sindh 75350,
Pakistan.
Name, address of Manufacturing site. M/s Hudson Pharma Private Limited
D-93, North Western Industrial Zone,
Pakistan.
☐ Importer
Becloson Suspension for Nebulisation 0.8mg/2ml
brand name
Strength / concentration of drug of Each 2ml of suspension contains:
Active Pharmaceutical ingredient Beclomethasone dipropionate….. 0.8mg
(API) per unit
Pharmaceutical form of applied drug Suspension for Nebulisation
Pharmacotherapeutic Group of (API) Corticosteroid

In-house
specifications
Proposed Pack size 2ml × 1’s, 5’s & 10’s
The status in reference regulatory Product is registered in Italian Medicine
authorities Agency (AIFA), with the brand name “Clenil” by
Chiesi Farmaceutici, Italy.
For generic drugs (me-too status) Manufacturer name: Chiesi Farmaceutici, Italy.
Importer: Chiesi Pharmaceutical (Pvt.) Ltd. Brand
name: Clenil,
Strength: 0.8mg/2ml,
Registration number: 014091

GMP status of the Finished product New section granted on 24/11/2021
manufacturer Injectable Ampoule BF (steroid) - New
Name and address of API FARMABIOS S.p.A.Via Pavia, 1 27027 Gropello
manufacturer. Cairoli, (PV) Italy.
Module III (Drug Substance) Official monograph of Beclomethasone
dipropionate is present in USP. The firm as
drug substance
months
Batches: (0081300, 0091300, B0111322)
months
Batches: (0031130, 0101515, 0111515,)
validation studies, batch analysis and justification
product.
comparative dissolution profile against the innovator product that is Clenil
Suspension for Nebulisation 0.8mg/2ml
Batch - 1134222 by Chiesi Farmaceutici, Italy
validation/verification of product including linearity, Limit of Quantitation (LOQ),
specificity, accuracy, precision (repeatability and
intermediate), robustness and range.
Manufacturer of API M/s FARMABIOS S.p.A. Via Pavia, 1 27027 Gropello Cairoli, (PV)
Italy
API Lot No. 2106DM4
Description of Pack Two aluminium pouches present in a unit carton with leaflet. Each

(Container closure system) aluminium pouch contain 2ml x 5s product filled in plastic Ampoule
(LDPE) 10 mono dose vials
Batch No. SB-BD-NU-04 SB-BD-NU-05 SB-BD-NU-06
Batch Size 2 Liters 2 Liters 2 Liters
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No.IT-API/167/H/2020
certificate of API manufacturer issued issued by Italian Medicine Agency valid till
by concerned regulatory authority of 12/06/2023.
country of origin.
3. Documents for the procurement of Firm has submitted copy of Form 6 invoice
API with approval from DRAP (in (invoice# 380) Dated 19-11-2021 cleared by
case of import). DRAP Karachi office dated 10-12-2021
specifying import 0.2g Beclomethasone
dipropionate (Batch# 2106DM4).
4. Data of stability batches will be Firm has submitted record of testing of all batches
supported by attested respective along with raw data sheets, COA and summary
documents like chromatograms, Raw data sheets.
sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail reports on product
software 21CFR & audit trail reports testing
on product testing
temperature and humidity monitoring for temperature and humidity monitoring of real
of stability chambers (real time and time and accelerated stability chambers.
accelerated)
1. 1.5.7 Aerosol for Nebulization Our applied formulation is in suspension
mentioned in this section. form which is used as nebulisation for
Clarification is required about aerosol. So, our formulation route of
applied formulation administration is Suspension for
nebulisation for aerosol, and the same
has been mentioned on the innovator
(Clenil) pack.
2. 3.2.P.5.3 Analytical Method Verification Analytical Method Verification studies
studies including specificity, including specificity, accuracy and
accuracy and repeatability repeatability (method precision)

(method precision) performed by performed by the Drug Product
the Drug Product manufacturer manufacturer drug substance(s)
drug substance(s) shall be submitted.
submitted.
3. 3.2.S.5 COA of primary / secondary With reference to this query we would
reference standard Testosteron like to inform you that at the time of
Propionate including source and initial testing of Beclomethasone
lot number shall be provided. Dipropionate, the internal standard
testosterone propionate was not available
to us due to import constraints of the
USP primary reference standard. Hence,
we have used the same method as per
USP without internal standard and
complete validation has been performed
to validate our results and also compare
it with manufacturer results as well.
Furthermore, we have ordered for

working standard of Testosterone
propionate from Merck, Same will be
used for the release testing in future
consignment. The complete method of
validation is already submitted.
4. 3.2.P.5.4 The copies of complete analysis CoA’s attached
of at least two batches shall be
provided.
5. 3.2.P.8 • Sterility testing and • We have performed the Sterility
Uniformity of dose units not testing and Uniformity of dose on all
included in initial testing. stability batches and results are
• Manufacturing date on within range. CoA’ are attached.
summary sheets of stability
studies for batch SB-BD-NU- • There is a Typo-graphical error in the
05 & SB-BD-NU-06 is 12- stability sheets of both batches but
2021 while in BMR the actual manufacturing date was
manufactured on 03-01-2022. 03-01-2022 as per BMR’s.
• Details of Water loss test for 6 • Details of Water loss test for 6
months not submitted. months submitted.

351. Name, address of Applicant / M/s Hudson Pharma Private Limited
Marketing Authorization Holder D-93, North Western Industrial Zone,
Pakistan.
Name, address of Manufacturing site. M/s Hudson Pharma Private Limited
D-93, North Western Industrial Zone,

Pakistan.
☐ Importer
The proposed proprietary name / Becloson S Suspension for Nebulisation 0.8mg +
brand name 1.6mg/2ml
Strength / concentration of drug of Each 2ml of suspension contains:
Active Pharmaceutical ingredient Beclometasone dipropionate…….. 0.8mg
(API) per unit Salbutamol sulphate 1.928mg equivalent to
salbutamol ……….1.6mg
Pharmaceutical form of applied drug Suspension for Nebulisation
Pharmacotherapeutic Group of (API) Corticosteroid and Selective beta-2-

adrenoreceptor agonists
In-house
specifications
Proposed Pack size 2ml × 1’s, 5’s & 10’s
The status in reference regulatory Product is registered in Italian Medicine
authorities Agency (AIFA), with the brand name “Clenil
Compositum” by Chiesi Farmaceutici, Italy.
For generic drugs (me-too status) Manufacturer name: Chiesi Farmaceutici, Italy.
Importer: Chiesi Pharmaceutical (Pvt.) Ltd. Brand
name: Clenil Compositum,
Strength: 0.8mg+1.6mg/2ml,
Registration number: 021199
GMP status of the Finished product New section granted on 24/11/2021
manufacturer Injectable Ampoule BF (steroid) - New
Name and address of API Beclomethasone dipropionate:
manufacturer. FARMABIOS S.p.A.Via Pavia, 1 27027 Gropello
Cairoli, (PV) Italy.
Salbutamol sulphate:
LUSOCHIMICA SpA –
Via Giotto 9 – 23871 Lomagna (LC) – ITALY
and its validation, batch analysis and justification

substances.
procedures, validation of analytical procedures,
Module III (Drug Substance) Official monograph of Beclomethasone
dipropionate is present in USP and Salbutamol
sulphate is present in BP. The firm has submitted
Stability studies Beclomethasone dipropionate:
months
Batches: (0081300, 0091300, B0111322)
months
Batches: (0031130, 0101515, 0111515,)
months
months
Batches: (SAL 104, SAL 204, SAL 304)
validation studies, batch analysis and justification
product.
comparative dissolution profile against the innovator product that is Clenil
Compositum Suspension for Nebulisation
0.8mg+1.6mg/2ml
Batch - 1136521 by Chiesi Farmaceutici, Italy
validation/verification of product including specificity, linearity/range, accuracy,
precision (repeatability and intermediate), Limit of

Quantitation (LOQ), Limit of Detection (LOD) and
robustness.
Manufacturer of API Beclomethasone dipropionate:
M/s FARMABIOS S.p.A.Via Pavia, 1 27027 Gropello Cairoli, (PV)
Italy.
M/s LUSOCHIMICA SpA – Via Giotto 9 – 23871 Lomagna (LC) –
ITALY
API Lot No. Beclomethasone dipropionate: 2106DM4
Salbutamol sulphate: SALM119
Description of Pack Two aluminium pouches present in a unit carton with leaflet. Each
(Container closure system) aluminium pouch contain 2ml x 5s product filled in plastic Ampoule
(LDPE) 10 mono dose vials
Batch No. SB-BS-NU-01 SB-BS-NU-02 SB-BS-NU-03
Batch Size 2 Liters 2 Liters 2 Liters
No. of Batches 03
2. Approval of API/ DML/GMP Beclomethasone dipropionate:
certificate of API manufacturer issued Copy of GMP certificate No.IT-API/167/H/2020
by concerned regulatory authority of issued by Italian Medicine Agency valid till
country of origin. 12/06/2023.
Copy of GMP certificate No.IT-API/69/H/2019
issued by Italian Medicine Agency valid till
03/08/2022.
3. Documents for the procurement of Beclomethasone dipropionate :
API with approval from DRAP (in Firm has submitted copy of invoice (invoice#
case of import). 380) Dated 19-11-2021 cleared by DRAP Karachi
office dated 10-12-2021 specifying import 0.2g
Beclomethasone dipropionate (Batch#
2106DM4).
112) Dated 27-03-2020 cleared by DRAP Karachi
office dated 23-04-2022 specifying import 5kg
Salbutamol Sulphate (Batch# SALM119).

4. Data of stability batches will be Firm has submitted record of testing of all batches
supported by attested respective along with raw data sheets, COA and summary
documents like chromatograms, Raw data sheets.
sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail reports on product
software 21CFR & audit trail reports testing.
on product testing
temperature and humidity monitoring for temperature and humidity monitoring of real
of stability chambers (real time and time and accelerated stability chambers.
accelerated)
1. 1.5.2 Specify the equivalent strength of Each 2ml of suspension contains:
the base for Salbutamol sulfate Beclometasone dipropionate 0.8mg
Salbutamol sulphate 1.928mg equivalent
to salbutamol 1.6mg
2. 1.5.7 Aerosol for Nebulization Our applied formulation is in suspension
mentioned in this section. form which is used as nebulisation for
Clarification is required about aerosol. So, our formulation route of
applied formulation administration is Suspension for
nebulisation for aerosol, and the same
has been mentioned on the innovator
(Clenil Compositum) pack.
3. 2.3.R.1.1 Source of Salbutamol Sulfate in A typographical error in the BMR and
BMR’s is from Cipla. we have used the salbutamol sulfate
Clarification is required. manufactured by Lusochimica and it can
be verified from the CoA of FPP
manufacturer for the same lot number.
4. 3.2.S.4.3 Analytical Method Verification Analytical Method Verification studies

studies including specificity, including specificity, accuracy and
accuracy and repeatability repeatability (method precision)
(method precision) performed by performed by the Drug Product
the Drug Product manufacturer of manufacturer of both drug substances
both drug substances (Beclometasone dipropionate &
(Beclomethasone dipropionate Salbutamol sulphate) shall be submitted.
&Salbutamol sulphate shall be
submitted..
5. 3.2.S.5 COA of primary / secondary With reference to this query we would
reference standard Testosteron like to inform you that at the time of
Propionate including source and initial testing of Beclomethasone
lot number shall be provided. Dipropionate, the internal standard
testosterone propionate was not available
to us due to import constraints of the
USP primary reference standard. Hence,
we have used the same method as per
USP without internal standard and
complete validation has been performed
to validate our results and also compare
it with manufacturer results as well.

Furthermore, we have ordered for
working standard of Testosterone
propionate from Merck, Same will be
used for the release testing in future
consignment. The complete method of
validation is already submitted.
6. 3.2.P.8 • Sterility testing and • We have performed the Sterility
Uniformity of dose units not testing and Uniformity of dose on all
included in initial testing. stability batches and the results are
• Details of Water loss test for 6 within range.
months not submitted.
• Details of Water loss test for 6
months submitted.
Decision: Registration Board deferred the case for further deliberation regarding manufacturing
requirement of products containing steroidal and non-steroidal drug substance in one
formulation.
Variant Pharmaceuticals (Pvt.) Ltd (New Section)
CLB in its 282nd meeting held on 31st September 2021 has considered and approved the grant One
(01) Additional section to Variant Pharmaceuticals (Pvt.) Ltd
1. Liquid Injectable -Ampoule &
Vial (General)
Liquid Injectable -Ampoule & Vial (General)
352. Name, address of Applicant / Variant Pharmaceuticals (Pvt.) Ltd
Name, address of Manufacturing site. Variant Pharmaceuticals (Pvt.) Ltd
Plot # 5, M-2, Pharmazone, 26 Km Main
Sharaqpur Road District Sheikhupura.Pakistan
☐ Importer
Details of fee submitted PKR 30,000/-: Deposit Slip # 561999878
The proposed proprietary name / VARISOL 5ML STERILE WATER FOR
brand name INJECTION
Strength / concentration of drug of Each ampoule contains sterile water for injection
Active Pharmaceutical ingredient ….5ml
(API) per unit
Pharmaceutical form of applied drug Intravenous injection
Pharmacotherapeutic Group of (API) Diluent

USP specifications
specifications
The status in reference regulatory Sterile Water for injection 5ml by MEDEFIL INC.,
For generic drugs (me-too status) Sterile water for injection 5ml by M/s Getz pharma
(Pvt.) Ltd. (Pvt.) Ltd., Reg. No. 053043
lyophilized), General ampoule and vial section
Name and address of API Variant Pharmaceuticals Pvt. Limited.
manufacturer. Plot # 5, M-2, pharma zone, 26 km main
sharaqpur road district Sheikhupura. Pakistan
Module III (Drug Substance) Official monograph of water for injection is
tests for impurity & related substances,
Stability studies NA
comparative dissolution profile against the brand leader that is Sterile water for
injection 5ml by M/s GSK pakistan Batch # SJ4PO
by performing quality tests
Analytical method NA

Manufacturer of API Variant Pharmaceuticals Pvt. Limited.
Plot # 5, m-2, pharma zone, 26 km main sharaqpur road district
Sheikhupura. Pakistan
API Lot No. Lab21-001
Description of Pack
5ml glass ampoule
Batch No. T-001 T-002 T-003
Batch Size 2000 Ampoules 2000 Ampoules 2000 Ampoules
No. of Batches 03
2. Approval of API/ DML/GMP NA
country of origin.
3. Documents for the procurement of NA
case of import).
sheets etc.
on product testing
accelerated)
1. 3.2.S.2 Explain by which method bulk By distillation method bulk water (water
water (water for injection) for injection) prepared. Complete
prepared.. method is attached.
2. 3.2.S.4.4 Submit certificate of analysis for Certificate of analysis for batch no #
batch no # Lab21-002 and Lab21- Lab21-002 and Lab21-003 submitted
003.

3. 3.2.P.2.3 In manufacturing method no step Revised manufacturing method with
and for sterilization of water for step for terminal sterilization submitted.
3.2.P.3.3 injection included than how the
product is Sterile water for
injection.
4. 3.2.P.5,4 On certificate of analysis water Revise certificate of analysis with sterile
for injection mentioned. water for injection are submitted.
Clarification is required..
353. Name, address of Applicant / Variant Pharmaceuticals (Pvt.) Ltd
Name, address of Manufacturing site. Variant Pharmaceuticals (Pvt.) Ltd
Plot # 5, M-2, Pharmazone, 26 Km Main
Sharaqpur Road District Sheikhupura.Pakistan
☐ Importer
Details of fee submitted PKR 30,000/-: Deposit Slip # 96273520421
The proposed proprietary name / VARISOL 10ML STERILE WATER FOR
brand name INJECTION
Strength / concentration of drug of Each ampoule contains sterile water for injection
Active Pharmaceutical ingredient ….10ml
(API) per unit
Pharmaceutical form of applied drug Intravenous injection
Pharmacotherapeutic Group of (API) Diluent

USP specifications
specifications
The status in reference regulatory Sterile Water for injection 10ml by MEDEFIL
authorities INC., USFDA Approved.
For generic drugs (me-too status) Sterile water for injection 10ml by M/s Barrett
Hodgson., Reg. No. 024637
manufacturer

General Tablet, General Capsule, General Sachet
lyophilized), General ampoule and vial section
Name and address of API Variant Pharmaceuticals Pvt. Limited.
manufacturer. Plot # 5, M-2, pharma zone, 26 km main
sharaqpur road district Sheikhupura. Pakistan
Module III (Drug Substance) Official monograph of water for injection is
Stability studies NA
comparative dissolution profile against the brand leader that is Sterile water for
injection 10ml by M/s Barrett Hodgson Reg. No.
024637 by performing quality tests
Analytical method NA
Manufacturer of API Variant Pharmaceuticals Pvt. Limited.
Plot # 5, m-2, pharma zone, 26 km main sharaqpur road district
Sheikhupura. Pakistan
API Lot No. Lab21-004
Description of Pack
10ml glass ampoule

Batch No. T-001 T-002 T-003
Batch Size 2000 Ampoules 2000 Ampoules 2000 Ampoules
No. of Batches 03
2. Approval of API/ DML/GMP NA
country of origin.
3. Documents for the procurement of NA
case of import).
sheets etc.
on product testing
accelerated)
5. 3.2.S.2 Explain by which method bulk By distillation method bulk water (water
water (water for injection for injection) prepared. Complete
prepared.) method is attached.
6. 3.2.S.4.4 • Submit certificate of analysis • Certificate of analysis for batch no #
for batch no # Lab21-005 and Lab21-005 and Lab21-006 submitted.
Lab21-006. • Batch size on COA 30 litres
• Batch size on COA of Batch mentioned.
No # Lab21-004,,mentioned
2000 Ampoules ,however it is
bulk water. Clarification is
required.
7. 3.2.P.2.3 In manufacturing method no step Revised manufacturing method with
and for sterilization of water for step for terminal sterilization submitted.
3.2.P.3.3 injection included than how the

product is Sterile water for
injection.
8. 3.2.P.5,4 On certificate of analysis water Revise certificate of analysis with sterile
for injection mentioned. water for injection are submitted.
Clarification is required..
Highnoon Laboratories Limited, Lahore (New Section)
CLB in its 277th meeting held on 15th & 16th October 2020 has considered and approved the Three
(03) Additional section/Revised Section to M/s Highnoon Laboratories Limited.

3. Dry Powder Inhaler Capsule (Steroid) Section
4. Capsule (General) Section (Revised)
5. Tablet (General )Section (Revised) except
Compression VI area
Dry Powder Inhaler (Steroid)
354. Name, address of Applicant / Highnoon Laboratories Limited, Lahore
Name, address of Manufacturing site. Highnoon Laboratories Limited of 17.5km, Multan
Road, Lahore
☐ Importer
Seevair 50mcg Rotacaps
brand name
Active Pharmaceutical ingredient Glycopyrronium Bromide 63mcg equivalent to
(API) per unit Glycopyrronium …..50mcg

Glycopyrronium bromide 55mcg equivalent to
44mcg Glycopyrronium
Pharmaceutical form of applied drug Capsule for DPI (White to off-white powder filled
in capsule shell no 3 containing grey opaque cap
and transparent body.)

Pharmacotherapeutic Group of (API) Cholinergic Antagonist.
long-term, maintenance treatment of airflow
obstruction in patients with chronic obstructive
pulmonary disease (COPD).
Manufacturer’s Specs/ Innovator
specifications
Proposed Pack size 5’s, 7’s, 10’s, 14’s, 20’s, 28’s, 30’s, 50’s, 60’s,
100’s, 120’s
The status in reference regulatory Seebri Breezhaler® 44 micrograms inhalation
authorities powder, hard capsules, Ireland.
For generic drugs (me-too status) Seebri Breezhaler inhalational Powder hard
capsules by M/s. Novartis Pharma, Pakistan., Reg.
No. 078111
GMP status of the Finished product Copy of GMP certificate based on the evaluation
manufacturer conducted on 11-11-2021 and valid till
11/11/2023.
Name and address of API M/s MELODY HEALTHCARE PVT. LTD.
manufacturer. Plot No. J-73, MIDC, Tarapur, Boisar Dist. Palghar
– 401 506, Maharashtra, India.
Module III (Drug Substance) Official monograph of Glycopyrronium bromide is
present in BP/ Ph. Eur. The firm as submitted detail
months
Batches: (GLY/20003M1, GLY/20004M1,
GLY/20005M1)

drug product.
comparative dissolution profile against the brand leader that is Seebri breezhaler
inhalation powder hard capsule 50mcg by Novartis
(Singapore) PTE LTD by performing tests (DUSA
(Delivered dose uniformity by dosage sampling
apparatus), ACI (Aerodynamic particle size
distribution by Andersen cascade impactor (USP
Apparatus 3)).
CDP is not applicable in case of Dry powder
inhalers.
specificity.
Description of the delivery Complete description and specifications of
devices(Inhaler intended to be Delivery device describe orange and white body
marketed along applied formulation with transparent cavity inhaler device properly
sealed packed polythene and suitable to open shell
size 3 with smooth opening and
closing of device.
Manufacturer of API M/s MELODY HEALTHCARE PVT. LTD.
Plot No. J-73, MIDC, Tarapur, Boisar Dist. Palghar – 401 506,
Maharashtra, India.
API Lot No. GLY/20001
Description of Pack
Alu-Alu blister packed in unit carton (3 x 10’s)
Batch No. RD-21116 RD-21172 RD-21173
Batch Size 24,000 capsules 24,000 capsules 24,000 capsules
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. NEW-WHO-GMP/
certificate of API manufacturer issued CERT/KD/91716/2020/11/31377 issued by WHO
country of origin.

3. Documents for the procurement of Firm has submitted copy of invoice (invoice#
API with approval from DRAP (in MBR2021/GEB00070) Dated 28-8-2020 cleared
case of import). by DRAP Lahore office dated 23-10-2020
specifying import 25gm Glycopyrronium
bromide (Batch# GLY/20001).
sheets etc.
on product testing
accelerated)
1. 3.2.S.4.1 Clarify which specification were We are following Ph. Eur. Specifications
followed for drug substance for testing of drug substance. In case, of
testing by drug product Assay drug product manufacturer adopted
manufacturer. HPLC method of related substance
because:
1. In titration method Acetic
anhydride is used which is banned
in Pakistan.
2. Also, HPLC method is more
specific than titration method to
assure the specificity and DRAP
also prefer the HPLC method over
titration.
2. 3.2.P.1 Justification of overages in the As, drug substance is in micrograms
formulation(s) shall be submitted. (63mcg), so 10% overage is taken to
ensure content delivery dose of product.
The same also mandated by assay limit
(80% - 120%) of Product Monograph.
3. 3.2.P.8 • As per submitted record Batch • Batch No # RD-21116 was
No # RD-21116 was manufactured in 29-6-2021, while
manufactured in 29-6-2021 samples were placed in stability chamber
while and samples were on 09-2021, because it was the initial
placed in stability chamber on trial batch which was used for
09-2021 Clarification is development of testing method. During
required. this period, this batch was stored in
• Furthermore, Please justify quarantine under control storage
where batch was stored before condition.
placement in stability • Moreover, other two Batches RD-
chamber. 21172 & RD-21173 were manufactured
in Aug-2021 and placed in stability
chamber on 09-2021 and each batch
having batch size of 24,000 capsules.
Both batches comply with the stability

studies requirements of CTD guidelines
which stated that:
“3.2.P.8 Stability:
b). At least 2 batches having the
following minimum batch size
considering the scientific reliability
• OSDs: 5000 Units
• Oral Liquid/Suspension: 2000
• Injectable: 2000
• Aerosol and any other specialized
preparations: 500”.
• Firm shall submit master formulation without overage before issuance of registration
letter along with fee of Rs. 30,000/- for change/correction in composition as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
355. Name, address of Applicant / Highnoon Laboratories Limited, Lahore
Name, address of Manufacturing site. Highnoon Laboratories Limited of 17.5km, Multan
Road, Lahore
☐ Importer
Ultivair 50mcg/ 110mcg rotacaps
brand name
Active Pharmaceutical ingredient Glycopyrronium (as bromide) ……….50mcg
(API) per unit Indacaterol (as Maleate) …………….110mcg

Glycopyrronium (as bromide) ……….43mcg
Indacaterol (as Maleate) …………….85mcg
Pharmaceutical form of applied drug DPI Capsule (White to off white powder filled in
capsule shell no 3 containing grey opaque cap &
transparent body.)
Pharmacotherapeutic Group of (API) Cholinergic Antagonist.

long-term, maintenance treatment of airflow
obstruction in patients with chronic obstructive
pulmonary disease (COPD).
Manufacturer’s Specs/ Innovator
specifications
Proposed Pack size 5’s, 7’s, 10’s, 14’s, 20’s, 28’s, 30’s, 50’s, 60’s,
100’s, 120’s
The status in reference regulatory Ultibro Breezhaler 85 micrograms/43 micrograms
authorities inhalation powder hard capsules (MHRA
Approved).
For generic drugs (me-too status) Inbro DPI Capsule 110mcg + 50mcg by M/s.
Martin Dow Limited, Karachi, Pakistan approved
in 307th DRB meeting.
GMP status of the Finished product Copy of GMP certificate No. 06/2022-DRAP (AD-
manufacturer 334240006) issued by DRAP valid till 11/11/2023.
Name and address of API M/s MELODY HEALTHCARE PVT. LTD.
manufacturer. Plot No. J-73, MIDC, Tarapur, Boisar Dist. Palghar
– 401 506, Maharashtra, India.
Module III (Drug Substance) Official monograph of Glycopyrronium bromide is
present in BP. The firm as submitted detail of
Whereas, Indacaterol maleate complies

Manufacturer’s specifications. So, firm has
process and controls, tests for impurity & related
substance as per inhouse specifications.

1. Glycopyrronium bromide:
months
months
Batches: (GLY/20003M1, GLY/20004M1,
GLY/20005M1)
2. Indacaterol maleate:
months
months
Batches: (ICM/19004, ICM/19005, ICM/19006)
drug product.
comparative dissolution profile against the brand leader that is Ultibro Breezhaler
85 micrograms/43 micrograms inhalation powder
hard capsules by Novartis Pharma Stein AG by
performing tests (DUSA (Delivered dose
uniformity by dosage sampling apparatus), ACI
(Aerodynamic particle size distribution by
Andersen cascade impactor (USP Apparatus 3)).
CDP is not applicable in case of Dry powder
inhalers.
specificity.
Description of the delivery Complete description and specifications of
devices(Inhaler intended to be Delivery device describe orange and white body
marketed along applied formulation with transparent cavity inhaler device properly
sealed packed polythene and suitable to open shell
size 3 with smooth opening and
closing of device.
Manufacturer of API M/s MELODY HEALTHCARE PVT. LTD.
Plot No. J-73, MIDC, Tarapur, Boisar Dist. Palghar – 401 506,
Maharashtra, India.
API Lot No. Glycopyrronium bromide: GLY/20001
Indacaterol maleate: ICM/20005
Description of Pack
Alu-Alu blister packed in unit carton (3 x 10’s)

Batch No. RD-21115 RD-21170 RD-21171
Batch Size 24,000 capsules 24,000 capsules 24,000 capsules
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No. NEW-WHO-GMP/
certificate of API manufacturer issued CERT/KD/91716/2020/11/31377 issued by WHO
country of origin.
3. Documents for the procurement of Glycopyrronium bromide:
API with approval from DRAP (in Firm has submitted copy of invoice (invoice#
case of import). MBR2021/GEB00070) Dated 28-8-2020 cleared
by DRAP Lahore office dated 23-10-2020
specifying import 25gm Glycopyrronium
bromide (Batch# GLY/20001).
Indacaterol maleate:
MBR2021/GEB00070) Dated 28-8-2020 cleared
by DRAP Lahore office dated 23-10-2020
specifying import 25gm Indacaterol maleate
(Batch# ICM/20005).
sheets etc.
on product testing
accelerated)
1. 3.2.S.4.1 Clarify which specification were We are following Ph. Eur. Specifications
followed for drug substance for testing of drug substance. In case, of
(Glycopyrronium bromide) testing Assay drug product manufacturer adopted
by drug product manufacturer. HPLC method of related substance
because:
3. In titration method Acetic
anhydride is used which is banned
in Pakistan.

4. Also, HPLC method is more
specific than titration method to
assure the specificity and DRAP
also prefer the HPLC method over
titration.
2. 3.2.P.1 Justification of overages in the As, drug substance is in micrograms

formulation(s) shall be submitted. (63mcg), so 10% overage is taken to
ensure content delivery dose of product.
The same also mandated by assay limit
(80% - 120%) of Product Monograph.
3. 3.2.P.8 • As per submitted record Batch • Batch No # RD-21115 was

No # RD-21115 was manufactured in 11-6-2021, while
manufactured in 11-06-2021 samples were placed in stability
while and samples were
chamber on 09-2021, because it was
placed in stability chamber on
16-09-2021 Clarification is the initial trial batch which was used
required. for development of testing method.
• Furthermore, Please justify During this period, this batch was
where batch was stored before stored in quarantine under control
placement in stability storage condition.
chamber. • Moreover, other two Batches RD-
21170 & RD-21171 were
manufactured in Aug-2021 and
placed in stability chamber on 09-
2021 and each batch having batch
size of 24,000 capsules. Both batches
comply with the stability studies
requirements of CTD guidelines
which stated that:
“3.2.P.8 Stability:
b). At least 2 batches having the
following minimum batch size
considering the scientific reliability
• OSDs: 5000 Units
• Oral Liquid/Suspension: 2000
• Injectable: 2000
• Aerosol and any other specialized
preparations: 500”.
• Firm shall submit master formulation without overage before issuance of registration
letter along with fee of Rs. 30,000/- for change/correction in composition as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.

Case no. 03 Registration applications for local manufacturing of (veterinary) drugs
a. Deferred Cases
356. Name and address of M/s Farm Aid Group.
manufacturer / Applicant Plot # 3/2, Phase I & II, Hattar Industrial Estate,
Haripur
Brand Name +Dosage Form + CB DOX Powder
Strength
Composition Each 1000gm contains:
Doxycycline HCL…200gm
Tylosin Tartrate…100gm
Colistin Sulphate…480MIU
Bromhexine HCL…5gm
27-12-2018
Type of Form Form-5
Finished product Specification Manufacturer specification
10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500g,
Pack size & Demanded Price 1kg,
5kg, 10kg,: Decontrolled
Me-too status Emeria Shell Powder Of M/S Inshal Pharmaceutical
GMP status Last GMP inspection conducted on 03-10-2018
report concludes that firm was considered to be
maintaining satisfactory level of the cGMP
IV
Remarks of the Evaluator
Previous decision (M-295) Deferred for conversion of Colistin Sulphate MIU to
grams
Evaluation by PEC Firm submitted conversion as follows:
Conversion of Colistin Sulphate (MIU to grams)
19000 IU of Colistin Sulphate = 0.001 grams of
Colistin Sulphate
1 IU of Colistin Sulphate = 0.001/19000 grams of
Colistin Sulphate
1 MIU of Colistin Sulphate = 0.001/19000 x
1,000,000 grams of Colistin Sulphate
480 MIU of Colistin Sulphate = 25.263 grams
Decision: Registration Board deferred the case for justification of Colistin sulphate
conversion in the light of as per the document No. EMEA/MRL/016/95-Final
(Summary Report for colistin) issued by Committee for Veterinary Medical Products,
Colistin Base has been assigned a potency of 1000ug base activity per mg (30,000
IU/mg) and theoretical potency of Colistin Sulphate is 800ug per mg (24,000IU/mg).
357. Name and address of M/s Farm Aid Group.
manufacturer / Applicant Plot # 3/2, Phase I & II, Hattar Industrial Estate,
Haripur
Brand Name +Dosage Form + U Mox Powder
Strength
Composition Each gm contains:
Amoxicillin Trihydrate…200mg
Colistin Sulphate…60,000,000 IU
27-12-2018

Type of Form Form-5
Finished product Specification Manufacturer specification
10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500g,
Pack size & Demanded Price 1kg,
5kg, 10kg,: Decontrolled
Almoxin-C Water Soluble Powder Of M/S Breeze
Me-too status
Pharma
GMP status Last GMP inspection conducted on 03-10-2018
report concludes that firm was considered to be
maintaining satisfactory level of the cGMP
Remarks of the Evaluatoriv Colistine Sulphate 60,000,000 in applied formulation
while in submitted generic reference contain Colistine
Sulphate 60,00,000. Clarify.
Previous decision (M-295) Deferred for evidence of applied formulation/drug
already approved by DRAP (generic / me-too status)
along with registration number, brand name and name
of firm.
Evaluation by PEC Firm said that they applied formulation as follows:
Each gm contains:
Amoxicillin Trihydrate…200mg
Colistin Sulphate…60,00,000 IU
And submitted copy of covering letter as
proof.(However in form 5 a different strength)
Firm submitted conversion as follows:
Conversion of Colistin Sulphate (MIU to grams)
19000 IU of Colistin Sulphate = 0.001 grams of
Colistin Sulphate
1 IU of Colistin Sulphate = 0.001/19000 grams of
Colistin Sulphate
60,00,000 IU of Colistin Sulphate = 0.3158 grams

• Submission of Complete Dossier with revised form 5 for corrected formulation
and fee.
• For justification of Colistin sulphate conversion in the light of as per the
document No. EMEA/MRL/016/95-Final (Summary Report for colistin) issued
by Committee for Veterinary Medical Products, Colistin Base has been
assigned a potency of 1000ug base activity per mg (30,000 IU/mg) and
theoretical potency of Colistin Sulphate is 800ug per mg (24,000IU/mg).
Case no. 04 Registration applications of categories to be considered on priority

a. Import applications of priority categories defined by Registration Board in its 257th
meeting
i. Human
Deferred case:
358. Name, address of Applicant / Importer M/s Titlis Pharmaceuticals., 528-A Industrial
Estate, Raiwind Road, Lahore-Pakistan.
Details of Drug Sale License of importer License No: 05-352-0066-035681D
Address: 528-A, Sunder Industrial Estate
,Raiwind Road, Lahore
Validity: 02-Oct-2022

Status: by way of distributor
Name and address of marketing The Mentholum Company Limited, 1
authorization holder (abroad) Redwood Avenue Peel Park campus East
Killbride Scotland G74 5PE United Kingdom.
Name, address of manufacturer(s) The Mentholum Company Limited, 1
Redwood Avenue Peel Park campus East
Killbride Scotland G74 5PE United Kingdom.
Name of exporting country UK
Detail of certificates attached (CoPP, Detail of certificates attached (CoPP, Free
Freesale certificate, GMP certificate) sale certificate, GMP certificate)
• Original legalized COPP (Certificate#
PP10165236 ) issued by Medicine and
Healthcare Products Regulatory Agency
(MHRA) Dated: 19-02-2020
• Free Sale status: The COPP endorses the
free sale status of the applied product in
UK.
GMP status: Firm has submitted Legalized
copy of GMP certificate (Certificate No. UK
MIA 189 Insp GMP/GDP 189/11483-0019)
issued by Medicine and Healthcare Products
Regulatory Agency (MHRA) in the name of
M/s The Mentholatum Company Limited
issued on 22-01-2022
Details of letter of authorization / sole Sole agency agreement has been submitted The
agency agreement Mentholum Company Limited, 1 Redwood
Avenue Peel Park campus East Killbride
Scotland G74 5PE United Kingdom with M/s
Titlis Pharmaceuticals., 528-A Industrial
Estate, Raiwind Road, Lahore-Pakistan
Pakistan. Dated: 18-02-2020
☒ Importer
giver)
☐ Export sale
purpose only
Details of fee submitted PKR 100,000/- dated :05-10-2020
The proposed proprietary name / brand Deep Relief Gel/ Deep Relief Pain Relief Gel
name

Strength / concentration of drug of Active Each 1g of gel Contains:
Pharmaceutical ingredient (API) per unit Ibuprofen…….50mg (5%)
Levomenthol…..30mg (3%)
Pharmaceutical form of applied drug Topical gel for external use only.
Pharmacotherapeutic Group of (API) Non-steroidal anti-inflammatory drug
(NSAID)
Reference to Finished product Manufacturer specifications (In house)
specifications
Proposed Pack size 1’s x50gm, 1’s x100gm,
The status in reference regulatory MHRA Approved
authorities
For generic drugs (me-too status) ----
Name, address of drug substance Levomenthol: M/s BASF SE Carl- Bosch-
manufacturer Straβe 38-67056 Ludwingshafen Feral
Republic of Germany
Ibuprofen:
➢ M/s BASF Corporation, Highway 77
South USA- 78343 bishop Texas
&
➢ Hubei Granules-Biocause
Pharmaceutical Co.Ltd/China 122
Yangwan- Biocause China city Hubei
Province
Stability Studies of Drug Substance Levomenthol: Firm has submitted long term
(Conditions & duration of Stability studies) stability study data of 3 batches of drug
substance at 25°C ± 2°C / 60 ± 5% RH for 24
Ibuprofen: 25°C ± 2°C / 60 ± 5% months.
40°C ± 2°C / 75 ± 5% RH for 6 months.

process validation report, control of excipients,
Pharmaceutical Equivalence and Firm submitted that Deep Relief Gel (approved
Comparative Dissolution Profile by MHRA-UK is an originator’s product
manufactured by Mentholatum company
Limited UK. Therefore pharmaceutical
equivalence through comparative dissolution
profile is not applicable on it.
Analytical method validation/verification of Firm has submitted analytical method
product verification studies of the drug product.
Container closure system of the drug product Printed, collapsible aluminium tube with a
membrane nozzle.
Stability study data of drug product, shelf Accelerated stability studies have been
life and storage conditions conducted at 40oC ±2oC / 75%±5% RH for 06
months.
Real time stability studies conducted at 25
o
C±2oC / 60% ± 5% RH and at 30 oC±2oC /
65% ± 5% RH for 36months.
However stability studies data at & 30 oC±2oC
/ 65% ± 5% RH starts from 9th month and in
protocols mentioned as Bracketing as per ICH
Q1A (R2) employed at the three and six month
time points means sample at & 30 oC±2oC /
65% ± 5% RH were only analysed in the event
of unsatisfactory results from 40oC ±2oC /
75%±5% RH storage condition.
Batch submitted:
Batch Trail Trial end Time points
No start date for Long
date Term
stability
studies
12401 24- 24-Apr- 0,9,12,18,24
Apr- 03 06 and 36
months
20181 16-Jul- 16- Jul- 0,9,12,18,24
09 09 and 36
months
21812 26- 26- 0,9,12,18,24
Aug-10 Aug- 13 and 36
months
14050 02- 02- Dec- 0,9,12,18,24
Dec- 04 07 and 36
months
Evaluation by PEC:

1. 1.6.5 Name and address of API Submitted
manufacturer not mentioned in this
section.
2. 3.2.P.8 In Submitted stability studies Firm submitted details that 8 batches stability
batches it is not evident that Drugdata submitted out of which in 6 batches source
substance Ibuprofen from which of Ibuprofen was
source is used. M/s BASF Corporation, Highway 77 South
USA- 78343 bishop Texas
And in 2 batches source of Ibuprofen was
Hubei Granules-Biocause Pharmaceutical
Co.Ltd/China 122 Yangwan- Biocause China
city Hubei Province
Previous Decision (M-317): Deferred for Evaluation of stability studies in the light of ICH Q1 D
guidelines.
Firm Reply: In response to valued decision of Drug Registration Board; we would like submit
that the stability of Deep Relief Gel is as per ICH Q1-D guidelines; and following clauses are
being presented for your kind review:
1- Clause 2.4.1 “Design factors that can be matrixed include batches made by using the
same process and equipment, and container sizes and/or fills in the same container
closure system.”
2- Clause 2.4.2“In a design where time points are matrixed, all selected factor combinations
should be tested at the initial and final time points.”
3- Clause 2.4.2“ data from at least three time points, including initial, should be available
for each selected combination through the first 12 months of the study.”
4- Clause 2.4.4“a matrixing design is applicable if the supporting data indicate predictable
product stability. Matrixing is appropriate when the supporting data exhibit only small
variability.”
It is humbly stated that the stability of Deep Relief Gel complies all the above clauses and hence
it is in accordance to ICH Q1-D Guidelines. The justification letter from the Manufacturer
(Mentholatum Company Limited/UK) is attached
In addition, we are also submitting the Complete Stability studies of three batches of Deep
Relief Gel according to Zone-IVA conditions (30±2 ℃ & 65%±5 RH)
Evaluation by PEC: Firm submitted Stability data of 3 batches in which Accelerated stability studies
have been conducted at 40oC ±2oC / 75%±5% RH for 06 months.
Real time stability studies conducted at 25 oC±2oC / 60% ± 5% RH and at 30 oC±2oC / 65% ± 5%
RH for 36months.And stability studies data at 30 oC±2oC / 65% ± 5% RH includes all the time points
i.e 0, 3, 6,9,12,18,24 and 36 months.
Batches submitted.
Batch No Trail start Trial end date Time points for Long Term stability
date studies
34982 13- Feb- 19 13- Feb- 22 0,3,6, 9,12,18,24 and 36 months
33789 14- May- 18 14- May- 21 0,3,6, 9,12,18,24 and 36 months
34048 06- Aug- 18 06- Aug- 21 0,3,6, 9,12,18,24 and 36 months
34938 29- Mar- 19 29- Mar- 22 0,3,6, 9,12,18,24 and 36 months

Decision: Approved with Innovator’s specifications as per Policy for inspection of
Manufacturer abroad and verification of local storage facility.
• Firm shall submit the fee of Rs. 7,500 for revision of specifications per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
359. Name, address of Applicant / Importer M/s Hakimsons Private Limited.,
Hakimsons House, A-58/B, S.I.T.E,
Manghopir Road, Karachi-75700, Pakistan.
Details of Drug Sale License of importer License No: 001 No. DHOKW (Drugs)/-0431
Address: A-58/B, S.I.T.E, Karachi
Status: Drug license by the way of wholesale
Name and address of marketing M/s Eugia Pharma Specialities Limited.
authorization holder (abroad) Survey No. 550, 551 & 552, Kolthur Village,
Shamirpet Mandal, Medchal-Malkajgiri,
District Medchal, Telangana, 500101, India.
Name, address of manufacturer(s) M/s Eugia Pharma Specialities Limited.
Survey No. 550, 551 & 552, Kolthur Village,
Shamirpet Mandal,
Medchal-Malkajgiri,
District Medchal, Telangana, 500101, India
Detail of certificates attached (CoPP, CoPP: Firm has submitted Original Legalized
Freesale certificate, GMP certificate) CoPP (Certificate#2850/STORES/2020-38)
issued by Drugs Control Administration,
Government of Telangana, India for
ENZASTIK Capsules 40mg (Enzalutamide).
CoPP confirms facilities and operations
conforming to GMP as recommended by the
World Health Organization. The certificate is
valid till 28.11.2021.
GMP certificate: The firm has submitted
copy of GMP certificate for M/s Eugia
Pharma Specialities Ltd. India issued by
Drugs control Administration, Government of
Telangana, India.
The certificate is valid till 28-11-2021.
Details of letter of authorization / sole Firm has submitted a copy of letter of
agency agreement authorization from M/s Aurobindo Pharma
Limited, plot No.2, Maitri Vihar, Ameerpet,
Hyderabad. According to the letter, the firm
has appointed “M/s Hakimsons Pvt. Ltd,”
with principal place of business at A-58/B,
S.I.T.E, Manghopir Road, Karachi as its
Exclusive Distributor for the territory of
Islamic Republic of Pakistan. The letter was
issued on 10-12-2020 and it is valid for a
period of five years.
The applicant has submitted notarized
copy of letter clarifying the relationship
between Eugia pharma specialities Limited
and Aurobindo Pharma Ltd.

Eugia pharma specialities Limited is wholly
owned subsidiary company of Aurobindo
Pharma Limited with registered office address
“Plot No.2, Maitrivihar, Ameerpet,
Hyderabad, Telanagana State, India.
Eugia pharma specialities Limited, with
manufacturing site address “survey no. 550,
551 & 552, kolthur village, shamirpet
Mandal, Medchal -Malkagiri District,
Telangana, India, manufactures oncology &
Hormonal products and is one of the
manufacturing facilities associated with
Aurobindo Pharma Limited.
☒ Importer
giver)
☐ Export sale
☐ Buk import and local repackaging for
export purpose only
Details of fee submitted PKR 100,000/- dated :04-02-2021
The proposed proprietary name / brand ENZASTIK – 40 Capsules 40mg
name
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Enzalutamide…….40mg
Pharmaceutical form of applied drug Soft gelatin capsule (Anti-neoplastic Agent)
Pharmacotherapeutic Group of (API) L02BB ; Anti-androgens
XTANDI is an androgen receptor inhibitor
indicated for the treatment of patients with:
• castration-resistant prostate cancer.
• Metastatic castration-sensitive prostate
cancer.
Reference to Finished product specifications In house
The status in reference regulatory authorities XTANDI (enzalutamide) capsules 40mg
(USFDA Approved).
For generic drugs (me-too status) ----

Name, address of drug substance M/s Laurus Labs Limited,
manufacturer Plot No. 21, Jawaharlal Nehru Pharma City,
Parawada, Visakhapatnam-531021
Andhra Pradesh, India Tel: +91-
891-3061222
Fax: +91-891-3061270
Module-III Drug Substance: Firm has submitted detailed drug substance
substance.
(Conditions & duration of Stability studies) batches of API at accelerated as well as real
time conditions 40 ± 2° C / 75 ± 5% RH . The
real time stability data is conducted at 25 ± 2°
C/60 ± 5%RH. The stability study data is till
24 months.

Pharmaceutical Equivalence and The firm has submitted physicochemical
Comparative Dissolution Profile evaluation of XTANDI 40 mg Capsules
manufactured by Astellas Pharma, Europe
B.V, Netherlands (Reference Drug Product)
and also submitted finished product evaluation
of Enzalutamide Capsules 40 mg by Eugia
Pharma Specialties Limited (Proposed
Generic Product) (B.No: EN4017003-B)
Analytical method validation/verification of Firm has submitted analytical method
product validation studies for the applied product.
Container closure system of the drug product PVC/PVDC/Aluminum foil blister pack
and storage conditions batches The accelerated stability study data is
conducted at 30oC ±2oC / 75% ± 5% RH. The
real time stability study data of 03 batches is
for 24months.
Evaluation by PEC:
S.No Section Shortcomings Reply
Communicated
1. 3.2.S.4.3 Analytical Method Submitted
Verification studies
including specificity,
(method precision)
Product manufacturer drug
substance(s) shall be
submitted.
2. 3.2.P.3.5 process validation reports All critical quality attributes mentioned in
including the protocols and 2.3.P.3.4/3.3.P.3.4 are covered in process validation
results for critical process reports except “Gelatin shell weight and Gelatin
steps mentioned in 2.3.P.3.4 gross weight of capsule” are not covered in process
/ 3.2.P.3.4 shall be provided. validation report. However, these are regularly
monitored as in process checks at initial and every
30 minutes and results are reported in batch
manufacturing record.
3. 3.2.P.5.2 US FDA review document Our product is a dosage form of soft gelatin capsule
of the Innovator product, formulation. Gelatin cross-linking is a common
specifies the dissolution problem of gelatin capsule, which is typically
limit as “NLT Q in 15 triggered by catalytic amounts of aldehydes and /or
minutes” 0.1N HCl/ 0.3% from exposure to high temperature and humidity.
CTAB, whereas submitted This impact is commonly seen in stability testing
specifications declare the and results in lower and/or incomplete dissolution
dissolution limits as “NLT invitro. Enzymes like pepsin and pancreatin act by
75% in 30 minutes” . Justify cleavage of peptide bonds present in cross- linked
the variation in time point of gelatin and there by resulting in release of content
dissolution. from capsule
Dissolution method for drug product
(Enzalutamide capsule 40mg) includes both Tier-I
media (with out enzymes) and Tier-II media [ith
inclusion of enzymes i.e., Pepsin added in 0.3%

CTAB(cetyl trimethyl ammonium bromide) in 0.1N
HCl]. In the instance of drug product failing to meet
the acceptance criteria in Tier-I due to gelatin
cross-linking , Tier-II method would be adopted.
Since the test product shows the cross linking
tendency, we have adopted the dissolution method
bot Tier-I and Tier-II in the analytical testing
methodology.. The tier-II dissolution testing for
cross-linked capsules involves two steps:
1) Pre-treatment
2) After Pre-treatment (main treatment)
In first step pre-treatment the cross-linked capsules
were subjected to exposure (pre-soaking) to pepsin
enriched media (450ml)for 10 minutes . After pre-
treatment remaining pre-warmed plain 0.1N HCl/
0.3% CTAB (without any pepsin) is added to
makeup the final volume to 900ml. therefore the
representation of dissolution time point [ Q time
point in Tier-I media is 30 minutes, which includes
10 minutes of pre-treatment step and remaining 20
minutes of main treatment in final volume.
Hence based on the above dissolution testing
discussion and considering the higher disintegration
time allowed for soft gelatin capsule, the following
dissolution limits are proposed for release and
stability shelf life testing of Enzalutamide capsule.
Test Adopted dissolution Limits

Release Shelf life
Dissolution NLT 75% Q in NLT 75% Q in
(%) 30 minutes 30 minutes
4. 3.2.P.8 From submitted stability All batches were tested with Tier-1 method up to 12
data for product it is not months and from 18 months station batches are
evident that dissolution tested with Tier-2 method. Stability data results with
testing conducted either on note “ Results pass at Tier-2 stage” are enclosed.
Tier-1, or Tier-2 or both.
Previous Decision: Deferred for following:
• Details of Reference Drug Product against which pharmaceutical equivalence and CDP
studies were performed.
• Clarification that Gelatin shell weight and Gelatin gross weight of capsule” are not
monitored in
process validation. (M- 317 RB)
Response of firm:
Details of Reference Drug Product against which The details of reference used against
pharmaceutical equivalence and CDP studies pharmaceuticals equivalence and CDP studies
were performed. are:
XTANDI 40 mg Capsules
Manufactured by Astellas Pharma, Europe B.V,
Netherlands.
Batch No. 15 D11/15
Clarification that Gelatin shell weight and Gelatin Please be informed that all critical quality
gross weight of capsule” are not monitored in attributes mentioned in 2.3.P.3.4/3.3.P.3.4 are
process validation. covered in process validation reports except

“Gelatin shell weight and Gelatin gross weight
of capsule” are not covered in process validation
report. However, these are regularly monitored as
in process checks at initial and every 30 minutes
and results are reported in batch manufacturing
record Please find enclosed herewith the pages of
in process control parameters along with in
process check record of the BMR for your ready
reference.
[Firm submitted BMR pages of 03 Batches
(Batch No# EN4017001, EN4017002 and
EN4017003) in which In process Control
parameters, where frequency(During start up
and every 30 minutes alternate by production
and QA) and limits for Gelatin shell weight
and Gelatin gross weight of capsule checks is
mentioned. Moreover they submitted sheets
for Start up checks by production and by QA
for Gelatin shell weight and gross weight of
capsule and In process check record every 30
minutes alternate by production and QA for
Gelatin shell weight and gross weight of
capsule]
• Evidence of requisite manufacturing facility i.e. soft gelatin cytotoxic as provided
document does not mention about dedicated facility.
• Submission of fee of Rs. 7,500 for revision of specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
Case no. 05 Miscellaneous cases

Azithromycin Tablet 500mg:
Composition:
Each Film coated tablet contains:
Azithromycin as dihydrate…….500mg
Availability in RRAs:
MHRA Approved
ME too status:
" Azic 500mg Tablet by M/s Nabi Qasim Reg # 055584
Specifications:USP
360. M/s Biorex Zithrorex Each tablet Form-5 10’s Last

Pharmaceuticals 500mg Tablet contains: Dy.No inspection
Plot No 251-A, Azithromycin as 13098 report is older
Industrial trihydrate…500m dated 06- than 3 years
Triangle, Kahuta g 03-2019
Road, Rs.20,000
Islamabad, /- Dated
Pakistan 06-03-
2019

Previous Deferred for updated status of GMP from QA & LT.
Decision (295-
DRB)
Evaluation by The firm have submitted GMP certificate issued on 28-01-2022 based
PEC on
inspection conducted on 09-12-2021
Previous Approved as per following label claim with USP specifications.:
decision (M- Each film coated tablet contains:
295) Azithromycin as trihydrate…500mg
Firm shall submit the fee of Rs. 7,500 for correction/pre-approval
change in composition
(correction/change of formulation from un-coated tablet to film coated
tablet), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Response of The firm has applied Azithromycin (as dihydrate), but in 316th meeting
firm Decision Azithromycin as trihydrate is mentioned. Kindly correct it.
Submitted fee of Rs: 7500/- Deposit slip # 52758099460 Dated: 24-05-
2022
Firm shall submit remaining fee for correction/pre-approval change in the salt form , as per
Agenda of Evaluator PEC-V
Item No. I: Agenda of Evaluator PEC-V

Case No. 1: Priority Consideration of drugs for Covid-19
361. Name, address of Applicant / M/s Pfizer Pakistan Limited,
Importer 12 Dockyard Road West Wharf, Karachi.
Details of Drug Sale License of DHOKW(Drugs)/148/License No. 029
importer Address: 12 Dockyard Road West Wharf, Karachi.
Address of go-down
12 Dockyard Road West Wharf, Karachi.
Status: License to sell drugs by way of Whole sale.
Name and address of marketing M/s Pfizer Limited
authorization holder (abroad) Ramsgate Road, Sandwich, Kent, CT13 9NJ, United
Kingdom
Name, address of manufacturer(s) Ritonavir Tablets
Bulk Tabs. Manufacturer, Testing and Release
M/s. Hetero Labs Limited,
Unit-III, 22-110,
Industrial Development Area, Jeedimetla, Hyderabad-
500055, Telangana, India
Nirmatrelvir Tablets
Manufacturer,Primary Packaging,Secondary
Packaging,Testing, Stability,Release of co-packs
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg,Mooswaldallee 1,79090
Freiburg, Germany

Detail of certificates attached (CoPP, • Firm has submitted copy GMP Certificate (No.
Freesale certificate, GMP certificate) DE_BW-01_GMP_2021_0006 dated 21-02-2021
valid till 07-10-2023 issued by Germany. The GMP
certificate specifies the GMP status of the
manufacturer.
• Firm has submitted Original and Legalized CoPP
(PP10175835) dated 18-02-2022 valid for five years
issued by Medicine and Healthcare Products
Regulatory Agency United Kingdom. The CoPP
specifies free sale status of the product in country of
origin along with its availability.
Details of letter of authorization / sole Original LOA has been submitted by firm dated 10-
agency agreement 02-2022
☒ Importer
purpose only
Dy. No. and date of submission Dairy No. 6640 Dated 10-03-2022
The proposed proprietary name / PAXLOVID 150 mg/100mg Film-Coated Tablets
brand name
Strength / concentration of drug of Each Pink Coloured Film coated tablet contains:
Active Pharmaceutical ingredient Nirmatrelvir…………150mg
(API) per unit Each White Coloured Film coated tablet contains:
Ritonavir……………100mg
Pharmaceutical form of applied drug Film Coated Tablets
Pharmacotherapeutic Group of (API) Protease Inhibitor Antiviral
PF-07321332 and ritonavir, in two different tablets.
PF-07321332 works by reducing the ability of SARS-
CoV-2 (the virus that causes COVID-19) to multiply
in the body while ritonavir prolongs the action of PF-
07321332 enabling it to remain longer in the body at
levels that affect the multiplication of the virus.
Reference to Finished product Pfizer Specs
specifications
Proposed unit price Firm has stated it will be provided later.
The status in reference regulatory MHRA approved (Conditional Grant)
authorities EMA:Conditional marketing authorisation

Module-II (Quality Overall Firm has not provided QOS.
Summary) Firms response
An up-to-date Quality Overall Summary (QOS) that
summarizes the complete module 3 content is not
available currently. Due to accelerated development
timelines in response to the pandemic, the dossier was
submitted to MHRA and subsequently updated as part
of a rolling submission process. The QOS included
with this dossier is intended to provide a brief
introduction to the product only.
Nirmatrelvir (PF-07321332)
Name, address of drug substance The following commercial sites are involved in
manufacturer manufacturing of drug substance:
Pfizer Ireland Pharmaceuticals, Ringaskiddy
Site 1
Active Pharmaceutical Ingredient Plant
Ringaskiddy County Cork, Ireland
Jilin Asymchem Laboratories Co. Ltd, No. 99,
Site 2
Hongda Road, Economic Development Zone,
Dunhua, Jilin 133700, China (CHN)
Changzhou SynTheAll Pharmaceutical Co.
Site 3
Ltd No.589, North Yulong Road, Xinbei

District, Changzhou, CH 213127, China
(CHN)
Module-III Drug Substance: General Information
• Nirmatrelvir was formally known as PF-
07321332.
• Polymorphism: Form 1 is the
thermodynamically most stable form at
relevant temperatures and humidity and is used
for development and emergency application
supplies.
• Chirality: PF-07321332 has 6 asymmetric
centers, giving 32 possible stereoisomers.
• There are no cis-trans isomers for PF-
07321332.
• White to pale colored powder.
Manufacture, characterisation and process
controls
A total of six synthetic routes have been used to
manufacture supplies of PF-07321332. There are two
processes used in the manufacture of PF-07321332,
Synthetic Route F and Synthetic Route G.
There is no process validation as there is no aseptic
processing or sterilization in the manufacture of PF-
07321332.
Specification
Provisional Specifications have been provided for
synthetic route F and G.
Provisional analytical procedures used to control the
manufacture of PF-07321332. The final analytical
methods for registration will be validated in
accordance with ICH guidelines.

Container Closure System
PF-07321332 is packaged in two sealed, low density
polyethylene (LDPE) anti-static liners.The bagged
material is then inserted in a high density polyethylene
(HDPE) drum or equivalent secondary container.
Stability Studies of Drug Substance The stability of PF-07321322 synthetic routes C and D
(Conditions & duration of Stability are supportive of synthetic routes F and G as all
studies) synthetic routes have the same polymorph, similar
synthetic chemistry, and same final solvents.
Condition (6months)
40°C/75% RH
25°C/60% RH
Shelf life
A retest date has been assigned to be 12 months at 15
– 30°C. Emergency supply batches of PF-07321332
drug substance manufactured at the commercial site
will be placed on stability at 30°C/75% RH and
40°C/75% RH in support of this storage condition.
The stability data sheets of synthetic route F and G are
not available.
Ritonavir
Name, address of drug substance The following commercial sites are involved in
manufacturer manufacturing of ritonavir:
M/s. Hetero Drugs Limited, Unit-IX,
Plot No. 1, Hetero Infrastructure SEZ Ltd.,
N. Narasapuram (Village), Nakkapalli (Mandal),
Visakhapatnam District-531081, Andhra Pradesh,
INDIA.
Module-III Drug Substance: General Information
• Polymorphism : Ritonavir exhibits
polymorphism. Hetero produces crystalline
Form-I.
• Isomerism : Ritonavir (Form-I) exhibits
isomerism. It contains four chiral centers.
• White or almost white powder.
Manufacture, characterisation and process
controls
The molecular structure of Ritonavir (Form-I) (B. No.
RI0020410) was investigated and confirmed by IR,
UV, NMR (Proton & Carbon), Mass spectroscopic
techniques.
Specification
• The specification limits followed for drug
substance is fixed based on process capability,
Ph. Eur. monograph of Ritonavir (Form-I) and
ICH recommendations.
• The analytical methods used in the analysis of
Ritonavir (Form-I) are Related compounds
(By HPLC), Assay (By HPLC, on anhydrous
basis), Residual solvents (By GC). These
methods were qualified for regular analysis.
Container Closure System

The API is packed in transparent polythene bags
placed in an HDPE drum.
Stability Studies of Drug Substance Accelerated

(Conditions & duration of Stability 40±2°C/75±5% RH
studies) 0, 1, 2, 3, 4, 5, 6
Intermediate
30±2°C/65±5% RH
0, 1, 3, 6, 9, 12
Long Term
25±2°C/60±5%RH
0, 1, 2, 3, 4, 5, 6, 9,12, 18, 24, 36, 48, 60
Shelf life/Retest
Retest period of 60 months
Paxlovid finished medicinal product
The proposed medicinal product Paxlovid consists of PF-07321332 150 mg film-coated
tablets and ritonavir 100 mg film-coated tablets, which are separately manufactured, but co-
packaged on the same blister for ease of daily co-administration.
Nimatrelvir film-coated tablets
Module-III Drug Product: Description of the product and pharmaceutical
Nimatrelvir film-coated tablets development
The proposed dosage form for PF-07321332 is an
immediate release (IR) film-coated tablet in dosage
strength of 150 mg. The dosage form is presented as
an oval, pink, film-coated tablet with “PFE” debossed
on one tablet face and “3CL” debossed on the opposite
tablet face.
Manufacture of the product and process controls
Manufacturing Site
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg,Germany
Process validation: The manufacturing process for PF-
07321332 150 mg film-coated tablets use
conventional manufacturing techniques and
equipment. The manufacturing & packaging process
validation will be completed and provided as part of a
forthcoming submission when final process and
controls will have been identified and appropriate
process understanding has been developed.
Stability data
Manufacture Site:Pfizer ,Freiburg, PPD
Container:Foil blister
3 months data submitted
Pharmaceutical Equivalence and Nirmatrelvir: Not applicable for innovator products.
Analytical method Nirmatrelvir:
validation/verification of product Firm has submitted that analytical method validation
studies for drug product has been performed. These
analytical procedures were verified and confirmed
suitable for their intended use. Non-compendial

analytical procedures used for batch release and
stability studies.
Ritonavir Film coated Tablets
Module-III Drug Product: Description of the product and pharmaceutical
Ritonavir film-coated tablets development
White to off white, capsule shaped, film-coated
tablets, debossed with ‘H’ on one side and ‘R9’ on
other side.
Manufacture of the product and process controls
Manufacturing Site
Ritonavir:
I. Bulk tablet manufacturing M/s. Hetero Labs
Limited, Unit-III, 22-110, Industrial
Development Area, Jeedimetla, Hyderabad-
500055, Telangana, India
II. Ritonavir Premix (Amorphous) manufacturing
M/s. Hetero Drugs Limited, Unit-IX, Plot No.
1, Hetero Infrastructure Ltd.- SEZ,
Narasapuram Village, Nakkapally Mandal,
Visakhapatnam District-531081, Andhra
Pradesh, India.
Stability data of bulk Tablets is available.
Pharmaceutical Equivalence and Ritonavir tablets were developed in reference to
Comparative Dissolution Profile NORVIR® Manufactured by Abbott Laboratories
Ltd., (Manufactured by Abbott laboratories. North
Chicago, IL 60064, U.S.A).
The dissolution methods developed indicated good
comparison with Norvir®.
Analytical method The method validations were performed for Related
validation/verification of product compounds (By HPLC), Assay (By HPLC), Residual
solvents (By GC).
Paxlovid finished medicinal product
The proposed medicinal product Paxlovid consists of PF-07321332 150 mg film-coated
tablets and ritonavir 100 mg film-coated tablets, which are separately manufactured, but co-
packaged on the same blister for ease of daily co-administration.
Container closure system of the co- Paxlovid is packaged in cartons containing 5 daily-
pack dose OPA/Al/PVC foil blister cards of 30 tablets.
Each daily blister card contains 4 Nirmatrelvir tablets
(Pink) and 2 ritonavir tablets (White).
The container closure system for PF-07321332 150
mg film-coated tablets and externally sourced
ritonavir 100 mg film-coated tablets consists of a
foil/foil blister system made from a composite
Oriented PolyAmide/Aluminium
Foil/Polyvinylchloride (OPA/Al/PVC) foil blister
with aluminium foil lidding where each tablet is placed
into an individual blister cavity.

Stability study data of Co-pack drug Stability data for Ritonavir 100 mg Tablets in the
product, shelf life and storage Pfizer co-packaged foil/foil blister system is currently
conditions not available.
Stability studies for the co-packaged drug product
(containing both Nirmatrelvir and ritonavir tablets) in
commercial packaging are currently scheduled to start
between March and May 2022.
Stability studies will be performed at long term storage
conditions of 30 °C/75% RH and 25°C/60% RH and
accelerated conditions of 40 °C/75% RH.
Stability data for the individual tablets are provided.
Nirmatrelvir film coated tablets Shelf life
Due to the accelerated pharmaceutical development,
limited primary stability data is currently available for
the PF-07321332 150 mg film-coated tablet.
Preliminary stability data for three primary batches of
the 150 mg tablets were reported for three months at
the long-term storage conditions of 30°C/ 75% RH and
25°C/60% RH and at the accelerated storage
conditions of 40°C/ 75% RH.
To support the proposed 12-month shelf life, six
months of stability data for PF-07321332 tablets from
the three primary stability batches will be available in
March 2022.
Ritonavir Film coated shelf life
The commercially available Hetero Ritonavir 100 mg
tablet in foil/foil blister container closure system has
an approved shelf life of 24 months.
Copack Shelf Life
The final shelf life and storage condition for co-
package product will be based on the more stringent
shelf-life and storage condition
Based on the 3 months stability data for 3 batches of
Nirmatrelvir 150 mg film-coated tablets from the
primary registration stability program and up to 6
months stability data for supportive stability batches,
the proposed shelf-life is 12 months when “Stored at
room temperature 20°C to 25°C (68°F to 77°F);
excursions permitted between 15°C and 30°C (59°F
and 86°F)” for product packaged in foil/foil blisters.
Remarks of the evaluator
Shortcomings Query Firms response

1. QOS is not available. It is not available currently. Due to accelerated
development timelines in response to the pandemic, the
dossier was submitted to MHRA and subsequently
updated as part of a rolling submission process.
2. Total 6 synthetic routes have A total 6 synthetic routes have been used in the
been used in manufacture of manufacturing of Nirmatrelvir.
Nirmatrelvir (A,B,C,D,.E.F.G) The routes that will provide supplies to emergency
but the submitted stability data is supply are route F(Pfizer Ireland Current Source) and
of route C and D only. route G (China, future assessment).These routes have
Clarification regarding synthetic been used for initial manufacturing of Nirmatrelvir.
route, manufacturing and Five previous routes A,B,C,D and E(China)were used
stability site is required? to provide earlier development ,preclinical and clinical
• Pfizer Ireland Pharmaceuticals, supplies.
Ringaskiddy Active Stability studies at Pfizer Ireland Pharmaceuticals,
Pharmaceutical Ingredient Plant Ringaskiddy are ongoing. The 3-month interval stability
Ringaskiddy County Cork, analysis is under progress. The data will be made
Ireland available by April 2022.
• Jilin Asymchem Laboratories Given stability of 6 months of another site Wuxi Apptec
Co. Ltd, No. 99, Hongda Road, China(route C and D) is available. STA Pharmaceutical
Economic Development Zone, (WuXi STA), a subsidiary of WuXi AppTec.
Dunhua, Jilin 133700, China
(CHN)
• Changzhou SynTheAll
Pharmaceutical Co. Ltd No.589,
North Yulong Road, Xinbei
District, Changzhou, CH
213127, China (CHN).
3. 3.2.P.3.5. Process validation has The manufacturing process for PF-07321332 150 mg
not been performed for film-coated tablets uses conventional manufacturing
Nirmatrelvir Tablets? techniques and equipment. The manufacturing &
packaging process validation will be completed and
provided as part of a forthcoming submission when final
process and controls will have been identified and
appropriate process understanding has been developed.
Manufacturing site is expected to complete the protocol
development by July 2022.
4. Stability Data of co-pack has not Stability studies for the co-packaged drug product
been submitted? (containing both nirmatrelvir and ritonavir tablets) in
commercial packaging are currently scheduled to start
between March and May 2022 at all three sites,
depending on site packaging schedules.
Stability studies will be performed at long term
conditions 30°C/75% RH ,25°C/60% RH and
accelerated conditions of 30°C/75%.
To support 12 months shelf life ,six months stability for
nirmatrelvir tablets from the three primary stability
batches will be available in March 2022.
We commit to monitor stability data according to ICH
guidelines and will inform the authorities according to
GMP processes in the case of OOS results.
5. Clarification for Final release site Germany site is responsible for manufacturing and final
for drug product with respect to release of drug product. MHRA can mention a site name
COPP as it mentions Germany once only.

site as manufacturer and at
release site Ireland and Italy.
Decision of M-316: Registration Board deliberated the case in details and opined that as MHRA
of UK and US FDA has approved EUA (Emergency Use Authorisation) with certain post-
marketing conditions and Registration Board may also consider on same pattern / conditions.
However, the Board referred the case to DRAP Authority for priority consideration of
registration applications or otherwise considering the current situation of COVID-19 pandemic
in Pakistan.
Decision of 136th meeting of the Authority held on 20-05-2022:
The Authority in light of its previous decisions regarding out of queue treatment of
drugs/biologicals for COVID-19 treatment decided that registration applications of combo pack of
Nirmatrelvir 150mg and Ritonavir 100mg shall be considered out of queue considering the potential
of resurgence of COVID-19 in future. The same will also be communicated to M/o NHS,R&C.
Fresh Evaluation
Shortcomings Firms response Firms Response Firms Response

Query Dated 03-08-2022 Dated 25-08-2022
1. QOS is not It is not available Fresh Evaluation QOS is not available
available. currently. Due to Firm has not Due to application of
accelerated development submitted QOS. Emergency Use
timelines in response to Authorization, QOS
the pandemic, the dossier document has not
was submitted to MHRA been prepared. We
and subsequently updated will provide the QOS
as part of a rolling upon conversion to
submission process. full registration.
2. Total 6 synthetic A total 6 synthetic routes Fresh Evaluation Clarification
routes have been have been used in the Firm has submitted regarding
used in manufacturing of Stability data of Route manufacturing and
manufacture of Nirmatrelvir. F Pfizer Ireland
stability site of
Nirmatrelvir The routes that will Pharmaceuticals,
(A,B,C,D,.E.F.G) provide supplies to Ringaskiddy and Nirmatrelvir
but the submitted emergency supply are Route G. As informed through
stability data is of route F(Pfizer Ireland our initial application
route C and D Current Source) and route dossier (3.2.S.2.1 &
only. Clarification G (China, future Table 3.2.S.2.6-5),
regarding assessment).These routes three sites will be
synthetic route, have been used for initial involved in API
manufacturing manufacturing of manufacturing &
and stability site is Nirmatrelvir. supplies: (a) Pfizer
required? Five previous routes Ireland
• Pfizer Ireland A,B,C,D and Pharmaceuticals,
Pharmaceuticals, E(China)were used to Ringaskiddy, Ireland,
Ringaskiddy provide earlier (b) Jilin Asymchem
Active development ,preclinical Laboratories Co.
Pharmaceutical and clinical supplies. China & (c)
Ingredient Plant Stability studies at Pfizer Changzhou
Ringaskiddy Ireland Pharmaceuticals, SynTheAll
County Cork, Ringaskiddy are ongoing. Pharmaceutical Co.
Ireland The 3-month interval Ltd, China.
• Jilin Asymchem stability analysis is under As of now, Jilin
Laboratories Co. progress. The data will be Asymchem
Ltd, No. 99, made available by April Laboratories Co.
2022. China is supplying

Hongda Road, Given stability of 6 the API. We have
Economic months of another site already submitted 3-
Development Wuxi Apptec China(route month Stability Data
Zone, Dunhua, C and D) is available. of all above
Jilin 133700, STA Pharmaceutical mentioned sites
China (CHN) (WuXi STA), a through our letter
• Changzhou subsidiary of WuXi dated August 1, 2022
SynTheAll AppTec. (3.2.S.7.3 Stability
Pharmaceutical Data).
Co. Ltd No.589,
North Yulong
Road, Xinbei
District,
Changzhou, CH
213127, China
(CHN).
3. 3.2.P.3.5. ProcessThe manufacturing Fresh Evaluation 3.2.P.3.5. Process
validation has notprocess for PF-07321332 Process validation of Validation document
been performed 150 mg film-coated Nirmatrelvir Tablets for Nirmatrelvir
for Nirmatrelvir tablets uses conventional has not been
Tablets
Tablets? manufacturing submitted.
techniques and 3.2.P.3.5. Process
equipment. The Validation document
manufacturing & for Nirmatrelvir
packaging process Tablets will be
validation will be available shortly and
completed and provided provided to you as
as part of a forthcoming
soon it is received.
submission when final
process and controls will
have been identified and
appropriate process
understanding has been
developed.
Manufacturing site is
expected to complete the
protocol development by
July 2022.
4. Stability Data of Stability studies for the The stability data at Stability Data of co-
co-pack has not co-packaged drug all three sites, packaged drug
been submitted? product (containing both depending on site product
nirmatrelvir and ritonavir packaging schedules
We have submitted 3-
tablets) in commercial has not been
packaging are currently submitted month stability data
scheduled to start Stability data of site for co-packaged drug
between March and May Pfizer Ascoli, Italy product, packaged at
2022 at all three sites, Stability data of 3 Ascoli, Italy site.
depending on site months has been Please note Ascoli,
packaging schedules. submitted. Italy is one of our
Stability studies will be Manufacturing
qualified packaging
performed at long term site:Pfizer , Freiburg,
conditions 30°C/75% Germany sites.
RH ,25°C/60% RH and Packaging Site:Pfizer Data for Germany as
accelerated conditions of ,Ascoli, Italy packaging site will be
30°C/75%. API Site :Jilin, China

To support 12 months submitted as soon the
shelf life ,six months activity takes place at
stability for nirmatrelvir Nirmatrelvir site.
tablets from the three Mfg Date: 27 Jan
primary stability batches 2022
will be available in March Packaging date:7-
2022. Feb-2022
We commit to monitor Stability Start
stability data according to Date:11-March 2022
ICH guidelines and will Ritonavir
inform the authorities Mfg Date: 01 Sep
according to GMP 2021
processes in the case of Packaging date:7-
OOS results. Feb-2022
Stability Start
Date:11-March 2022
Fresh Evaluation
The API
manufacturing site as
mentioned in co-pack
stability data is Jilin,
China but as per your
previous submission it
will be Pfizer Ireland.
Clarification is
required.
5. Clarification for Germany site is The packaging site Clarification for

Final release site responsible for mentioned in stability Final release site for
for drug product manufacturing and final data of co-pack is drug product with
with respect to release of drug product. Pfizer, Ascoli, Italy
respect to COPP
COPP as it MHRA can mention a site whereas, as per your
mentions name once only. previous submission We submitted in our
Germany site as Germany site will be initial registration
manufacturer and responsible for application & CPP,
at release site manufacturing and that there is one
Ireland and Italy. final release of drug manufacturing &
product. Clarification three packaging sites
is required.
approved for
Paxlovid, (a) Pfizer
Manufacturing
Freiburg, Germany,
(b) Pfizer
Pharmaceuticals
Newbridge, Ireland,
& (c) Pfizer Ascoli,
Italy.
6. The storage condition for Co-pack is Store Below 25. Storage condition /
label of co-pack
The stringent long-
term condition of

30°C/75%RH is
being used in stability
data to support
climatic zones IVa/b
for labelling up to
30°C. Since we have
applied for EUA and
Paxlovid will be
supplied as
international standard
export Pack, hence
the label will mention
25oC.
Decision: Approved with Innovator’s specifications as per Policy for inspection of
Manufacturer abroad and verification of local storage facility.
• Firm shall submit the fee of Rs. 7,500 for revision of specifications, as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
• Firm will provide Quality Overall summary (QOS) on the basis of which MHRA has
accorded Emegency Use Authorization before issuance of Registration letter.
Case no. 02 Registration applications for local manufacturing of (Human) drugs

a. New cases
362. Name and address of M/s Fedro Pharmaceuticals Laboratories Private

manufacturer / Applicant Limited.
149-Industrial Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Sitafed Tablets 25mg
Strength
Sitagliptin as phosphate monohydrate…25mg
Diary No. Date of R& I & fee Dy.No 11912 dated 06-03-2019 Rs.20,000/- dated 06-03-
2019
Pharmacological Group Dipeptidyl peptidase 4 (DPP-4) inhibitor
Type of Form Form-5
Pack size & Demanded Price As per SRO,10’s,14’s,30’s.
Approval status of product in JANUVIA® (sitagliptin) Tablets.
Reference Regulatory USFDA Approved.
Authorities.
Sitagen Tablets 25mg.
Manufacturer Name
Ferozsons Laboratories
GMP status Not submitted.
Remarks of the Evaluator V Each film-coated tablet of innovator contains 32.13mg of
sitagliptin phosphate monohydrate, which is equivalent to
25mg whereas, master formulation mentions sitagliptin
32mg.Revision of master formulation with submission of
requisite fee is required.

Registration letter will be issued after submission of updated GMP status of the firm
and correction of composition as per innovator product along with submission of Rs.
30,000/-, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
2019
Type of Form Form-5
Approval status of product in JANUVIA® (sitagliptin) Tablets.
Authorities.
Sitagen Tablets.
Manufacturer Name
Remarks of the Evaluator V Each film-coated tablet of sitagliptin contains 64.25mg of
50mg. Revision of master formulation with submission of
Strength
2019
Type of Form Form-5
Approval status of product in JANUVIA® (sitagliptin) Tablets
Authorities.
Sitagen Tablets.
Manufacturer Name

Remarks of the Evaluator V Each film-coated tablet of innovator product contains
128.5 mg of sitagliptin phosphate monohydrate, which is
equivalent to 100mg whereas, master formulation
mentions sitagliptin 100mg. Revision of master
formulation with submission of requisite fee is required.
Brand Name +Dosage Form + Sitamet Tablets 50/500mg "
Strength
Metformin hydrochloride…500mg
2019
Pharmacological Group Drugs used in Diabetes
A10BD07
Type of Form Form 5
Finished product Specification Not submitted.
Pack size & Demanded Price As per SRO,10’s.
Approval status of product in Janumet.
Reference Regulatory Approved in USFDA with box warning.
Authorities.
Silmax-M 50mg/500mg Tablet
M/s High-Q Pharmaceuticals, Karachi . .
Remarks of the Evaluator V Each film-coated tablet of sitagliptin contains 64.25,mg of
Decision: Approved with innovator specifications.
Brand Name +Dosage Form + Sitamet Tablets 50/1000mg
Strength
Metformin hydrochloride…1000mg
Diary No. Date of R& I & fee Form-5 Dy.No 11914 dated 06-03-2019 Rs.20,000/-
dated 06-03-2019
Pharmacological Group Drugs Used In Diabetes
A10BD07
Type of Form Form 5

Pack size & Demanded Price 10’s,
Approval status of product in Janumet
Reference Regulatory Approved in USFDA with box warning.
Authorities.
Silmax-M 50mg/1000mg Tablet
M/s High-Q Pharmaceuticals, Karachi . .
Remarks of the Evaluator V Each film-coated tablet of sitagliptin contains 64.25,mg of
Brand Name +Dosage Form + Terbifed Tablets 125mg
Strength
Terbinafine hydrochloride…125mg
2019
Pharmacological Group Antifungals for systemic use
D01BA02
Type of Form Form 5
Pack size & Demanded Price 10s ,As per SRO.
Approval status of product in LAMISIL terbinafine 125mg (uncoated tablets)
Reference Regulatory TGA Approved.
Authorities.
"Terbizine Tablet
Candid Pharmaceuticals,Opposite Pasrur Sugar
Mills,Sialkot Road, Pasrur"
Remarks of the Evaluator V Evidence of approval of the applied formulation as film
coated tablet in one of the reference regulatory authority
specified by Registration Board or revision of label claim
as per innovator with submission of requisite fee is
required.
and correction of formulation from film-coated tablet to uncoated tablet along with
submission of Rs. 7,500/- , as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
Brand Name +Dosage Form + Tramafed Tablet 325/37.5mg
Strength

Paracetamol…325mg
Tramadol hydrochloride…37.5mg
2019
Pharmacological Group Opioids in combination with non-opioid analgesics.
N02AJ13
Type of Form Form 5
Pack size & Demanded Price As per SRO, 10’s
Approval status of product in Tramacet
Reference Regulatory Manufacturer/sponsor:Janssen Ortho Inc.
Authorities. Health Canada Approved
Radol-P Tablet 325/37.5 mg
M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5,
National industrial zone Rawat.Islamabad
Remarks of the Evaluator V
Brand Name +Dosage Form + Olanz F 6mg/25mg Capsules
Strength
Olanzapine citrate equivalent to Olanzapine…6mg
Fluoxetine hydrochloride equivalent Fluoxetine…25mg
2019
Pharmacological Group Antipsychotics
Type of Form Form 5
Pack size & Demanded Price As per SRO,14’s.
Approval status of product in Symbyax
Reference Regulatory USFDA Approved with box warning.
Authorities.
Olanzo – F 6/25 Capsule
Remarks of the Evaluator V The master formulation mentions olanzapine citrate 6 mg
and fluoxetine Hydrochloride 25 mg. Revision of
formulation as per innovator is required.
Evidence of olanzapine as citrate is required.
and correction of salt form of the drug substance along with submission of Rs.30,000/-

Brand Name +Dosage Form + Olanz F 12mg/25mg Capsules
Strength
Olanzapine citrate equivalent to Olanzapine…6mg
Fluoxetine hydrochloride equivalent to
Fluoxetine…25mg
2019
Pharmacological Group Antipsychotics
Type of Form Form 5
Pack size & Demanded Price As per SRO.
Approval status of product in Symbyax
Authorities.
Olanzo – F 12/25mg Capsule
Remarks of the Evaluator V The master formulation mentions olanzapine citrate 12
mg and fluoxetine HCl 25 mg. Revision of formulation as
per innovator is required.
Evidence of olanzapine as citrate is required.
and correction of salt form of the drug substance along with submission of Rs.30,000/-
Brand Name +Dosage Form + Amloval Tablet 5mg/80mg
Strength
Almodipine besylate equivalent to amlodipine…5mg
Valsartan…80mg
2019
Pharmacological Group C09DB01 Angiotensin II receptor blockers (ARBs) and
calcium channel blockers
Type of Form Form 5
Pack size & Demanded Price 10’s,14’s,As per SRO.
Approval status of product in Exforge
Authorities.
Amlodine Tablet 5/160
M/s Jupiter Pharma Plot # 25, St# S6 RCCI, Rawat
Islamabad
Remarks of the Evaluator V ➢ The pack size has not been provided on Form 5.
➢ The master formulation mentions amlodipine
besylate 5mg instead of amlodipine besylate

equivalent to Amlodipine…5mg.Revision of
formulation with submission of requisite fee is
required.
30,000/- as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Cordfed V Tablet 5mg/320mg
Strength
Amlodipine besylate equivalent to amlodipine…5mg
Valsartan…320mg
Diary No. Date of R& I & fee Dy.No 11918 dated 06-03-2019 Rs.20,000/- dated 06-
03-2019
Type of Form Form 5
Pack size & Demanded Price 10’s,14’s,As per SRO
Authorities.
Amlodine Tablet 5/320
M/s Jupiter Pharma Plot # 25, St# S6 RCCI, Rawat
Islamabad
besylate 5 mg instead of amlodipine besylate
equivalent to Amlodipine…5mg.Revision of
required.
Brand Name +Dosage Form + Cordfed V Tablet 10mg/320mg
Strength
Amlodipine besylate equivalent to amlodipine…10mg
Valsartan…320mg
Diary No. Date of R& I & fee Dy.No 11919 dated 06-03-2019 Rs.20,000/- dated 06-
03-2019
Type of Form Form 5

Pack size & Demanded Price 10’s,14’s,As per SRO
Authorities.
Lodopin-V Tablet 10mg/320mg
Martin Dow Marker Limited
GMP status 107700
Jemvartan by M/s Jaens Pharma, Lahore
besylate 10 mg instead of amlodipine besylate
equivalent to amlodipine…10 mg. Revision of
required.
Brand Name +Dosage Form + Valfed Tablet 80mg
Strength
Valsartan…80mg
2019
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain
Type of Form Form 5
Pack size & Demanded Price As per SRO,14’s
Authorities.
Brand Name
Varlan Tablets
Manufacturer Name
Siza International (Pvt) Ltd, 18 KM, Main Ferozepur
Road, Lahore-53001
Remarks of the Evaluator V The signature of applicant is missing on Form 5.
Registration letter will be issued after submission of signed Form 5 by the applicant.
375. Name and address of "M/s Friends Pharma Pvt Ltd.
manufacturer / Applicant 31-km, Ferozepur Road, Lahore, Pakistan"
Brand Name +Dosage Form + Ketafend Injection 500mg
Strength
Composition "Each 10ml Contains:
Ketamine Hcl Eq To Ketamine…500mg
2019
Pharmacological Group General anaesthetics

Type of Form Form 5
Pack size & Demanded Price As per SRO, Glass ampoule 10ml.
Approval status of product in USFDA approved in Vial .
Authorities.
Me-too status Ketarol of Global
GMP status GMP inspection 08-03-2019
General Liquid section (Vial and Ampoule)
Remarks of the Evaluator V • Revision of master formulation as per innovator is
required i.e. “50 mg ketamine base (equivalent to
57.67 mg ketamine hydrochloride” along with
• Availability of applied product in ampoule.
Evaluation
• Initially, the firm has applied for ampoule now the
firm has changed the container closure system to vial
without submitting relevant documents as per Form 5.
• Evidence of SVP couldn’t be confirmed from section
letter and panel inspection report.
• Firm has corrected the master formulation with
submission of Rs 7500/- dated 17-03-2022.
Decision: Deferred for the following reasons:
• Submission of evidence of approval of SVP section by the Central Licensing
Board or panel inspection report for renewal of DML verifying the section.
• Firm shall submit the full fee of Rs. 30,000/- for correction/pre-approval change
in composition (correction of salt form of the drug substance) and change of
container closure system, as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
376. Name and address of High Q Pharmaceuticals ,Plot No. 224, Sector
manufacturer / Applicant 23,Korangi Industrial
Diary No. Date of R& I & fee Dy. No.280 dated 18..9.2014
Brand Name +Dosage Form + Lefra 10mg Tablet

Strength
Leflunomide USP…10mg
Pharmacological Group L04AA13 Selective immunosuppressants
Type of Form Form 5
Pack size & Demanded Price As per brand Leader
Approval status of product in ARAVA (leflunomide), tablets
Reference Regulatory USFDA Approved
Authorities.
Me-too status Registration Number:103249
Brand Name:Ck-lef
Manufacturer Name:CKD Pharmaceuticals
GMP status GMP inspection report dated:30-06-2021
Remarks of the Evaluator V.

Brand Name +Dosage Form + Lefra 20mg Tablet
Strength
Leflunomide USP…20mg
Pharmacological Group L04AA13 Selective immunosuppressants
Type of Form Form 5
Pack size & Demanded Price As per brand Leader, 30’s
Approval status of product in ARAVA (leflunomide), tablets
Authorities.
Brand Name:Lefora 20mg Tablet
Manufacturer Name:Hilton Pharma (Pvt) Ltd,
Brand Name +Dosage Form + Topzol Capsule 100mg

Strength
Itraconazole …. 100mg
Pharmacological Group J02AC02 Antimycotic
Type of Form Form 5
Pack size & Demanded Price As per brand Leader, 4 capsule
Approval status of product in SPORANOX® (itraconazole) Capsules
Authorities.
Brand Name:Rolac 100mg Capsules Each capsule
Manufacturer Name:Sami Pharmaceuticals (Pvt) Ltd, F-
95 Off Hub River Road , SITe, Karachi
Remarks of the Evaluator V. Revision of formulation as per innovator is required i.e.

SPORANOX® Capsules contain 100 mg of itraconazole
coated on sugar spheres ,also submit fee for revision of
formulation.
USFDA Storage Condition
Store at controlled room temperature 15°-25°C.
Protect from light and moisture.
MHRA Storage Condition
Special precautions for storage
Do not store above 25°C Store in the original package in
order to protect from light.
Nature and contents of container
Aluminium/Aluminium Blister
Firms Response
Firm has revised their formulation with submission of Rs
7500/- dated 11-05-22.

Source of pellets: M/s Vision Pharmaceuticals.
Decision: Approved with USP specifications and storage condition “Do not store above
25°C”.
Registration letter will be issued after submission of remaining fee of Rs. 22,500/-, as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021, as Rs 7500/- has already
been submitted.
Brand Name +Dosage Form + Toprax 25mg tablet

Strength
Topiramate …25mg
Pharmacological Group N03AX11 Anti-epileptic
Type of Form Form 5
Pack size & Demanded Price As per Brand Leader, 30’s.
Authorities.
Me-too status Registration Number: 076387
Brand Name: Neutop 25mg Tablet
Manufacturer Name :Nabiqasim Kar.
GMP status GMP inspection date:30-06-2021
Brand Name +Dosage Form + Toprax 50mg tablet

Strength
Topiramate …50mg
Pharmacological Group N03AX11 Anti-epileptic
Type of Form Form 5
Pack size & Demanded Price As per Brand Leader, 60’s.
Approval status of product in Topamax Tablets
Authorities.
Me-too status Registration Number: 076388
Brand Name: Neutop 25mg Tablet
Manufacturer Name :Nabiqasim Kar.

Brand Name +Dosage Form + Ezolin 400mg tablet
Strength
Linezolid …400mg
Pharmacological Group Antibacterial for systemic use.
J01XX08
Type of Form Form-5
Finished product Specification Inhouse Spec.
Pack size & Demanded Price As per Brand leader,10’s
Approval status of product in ZYVOX Tablets
Reference Regulatory 400MG **Federal Register determination that product
Authorities. was not discontinued or withdrawn for safety or efficacy
reasons*
Discontinued USFDA Approved.
Lyzon 400mg Tablet
By M/s Getz Pharma Karachi
Registration letter will be issued after submission of Rs. 7,500 for correction in product
b. Deferred Cases
382. Name and address of "M/s Universal Pharmaceuticals Pvt Ltd.

manufacturer / Applicant 131-A, Hayatabad Industrial Estate, Peshawar"
Brand Name +Dosage Form + Napsum Tablet

Strength
Sumatriptan succinate equivalent to sumatriptan…85mg
Naproxen sodium…500mg
Pharmacological Group Migraine Management
Type of Form Form-5
Pack size & Demanded Price 2’s,As per SRO.
Approval status of product in TREXIMET (sumatriptan and naproxen sodium) tablets
Authorities.
Me-too status 075904 /Sumtan Plus Tablet M/s Medisure
Karachi.
GMP status 09-01-2019
The firm has rectified majority of observations noted in
the previous inspection and the management is committed
to improve their cGMP compliance. The firm may be
considered operating in satisfactory level of cGMP
compliance.
Recommendations: They are advised to:
• Purchase FTIR and column oven for HPLC
• Provide a shelter on material entry gate.
• Increase number of dehumidifier in general
production area.

• Provide a split AC in dispensing room.
• Provide room for retention samples.
Decision of 295th Meeting: Deferred for updated GMP status from QA Division.
Evaluation by PEC-V:
Firm has submitted GMP inspection report dated:14-09-2020,15-09-2020.
Conclusion: Fair level of compliance.
Recommendation: The firm should rectify all the observations mentioned in the report within
30 days as agreed by the management of the firm.
Decision of M-307: Deferred for updated status of the GMP from QA and LT division for
rectification of shortcomings identified during the inspection.
Evaluation by PEC:
Date of Inspection 31-12-2021.
Satisfactory level of GMP compliance.
Registration letter will be issued after submission of Rs. 7,500/- for correction in product
Brand Name +Dosage Form + Delor 5mg tablets

Strength
Composition "Each film coated tablet Contains:
Desloratadine…5mg"
Pharmacological Group Anti-histamine for systemic use.
Type of Form Form-5
Approval status of product in CLARINEX® (desloratadine) Tablets,
Authorities.
Me-too status 080821 /Desdine 5mg Tablet M/s Hygeia Pharma,
Isbd.
to improve their cGMP compliance.The firm may be
compliance.
Recommendations:They are advised to:
production area.
Decision of 295th Meeting: Deferred for updated GMP status from QA Division.
Conclusion : Fair level of compliance.

Evaluation by PEC:
Date of Inspection 31-12-2021
Brand Name +Dosage Form + Ternix forte 4mg Tablets

Strength
Composition "Each Tablet Contains:
Tizanidine…4mg"
Pharmacological Group Muscle relaxants
Type of Form Form-5
Approval status of product in ZANAFLEX® (tizanidine hydrochloride) tablets,
Authorities.
Me-too status 080865 /Zinzan 4mg Tablet
" Wellborne Pharmachem and Biologicals, Hattar."
compliance.
production area.
Remarks of the Evaluator (V) • The firm has applied for only Tizanidine however,
the product is internationally approved as
Tizanidine as HCl.
Decision: Deferred for clarification regarding salt form of API along with submission of
requisite fee and updated GMP status of firm.
Decision of M-307: Deferred for the following reasons:
• Updated status of the GMP from QA and LT division for rectification of
shortcomings identified during the inspection.
• Revision of formulation as per reference product along with submission of
requisite fee.
Evaluation by PEC:
• Date of Inspection 31-12-2021

Firm has not revised the formulation.
Registration letter will be issued after correction of salt form of the drug substance as
per innovator product along with submission of Rs. 30,000/- as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Doksal 100mg/5ml Syrup

Strength
Composition "Each 5ml contains:
Doxofylline…100mg"
Pharmacological Group Systemic Drugs for Obstructive Airway Diseases
Type of Form Form 5
Pack size & Demanded Price 60ml glass bottle, plastic bottle. As per SRO.
Approval status of product in Ansimar
Reference Regulatory Company: Abc Farmaceutici Spa
Authorities. AIFA Approved.
Me-too status 047180/Unifyline Syrup
M/s Platinum Pharmaceuticals, Karachi
compliance.
production area.
Remarks of the Evaluator (V) Liquid syrup section is present.
Decision: Deferred for updated GMP status from QA Division.
Evaluation by PEC:

Brand Name +Dosage Form + Delor Syrup 2.5mg/ml
Strength
Desloratadine…2.5mg"
Pharmacological Group Antihistamines For Systemic Use
Type of Form Form 5
Pack size & Demanded Price 60ml amber glass,plastic bottle, As per SRO.
Approval status of product in Clarinex® (Desloratadine) and Oral Solution
Authorities.
Me-too status 076743/Genelor 2.5mg Syrup M/s Zanctok Karachi.
compliance.
production area.
Evaluation by PEC:
Brand Name +Dosage Form + Lezene 2.5mg/5ml

Strength
Levocetirizine Dihydrochloride…2.5mg"
Pharmacological Group Antihistamines for systemic use
Type of Form Form 5
Pack size & Demanded Price 60ml plastic bottle,amber glass,As per SRO.

Approval status of product in XYZAL oral solution
Reference Regulatory USFDA approved.
Authorities.
Me-too status 076688/Atiza Syrup 2.5mg/ 5ml M/s Asian Continental
compliance.
production area.
Evaluation by PEC:
Firm has not provided reference for specification.
388. Name and address of manufacturer / M/s Welborne Pharmachem and Biologicals, Plot
Applicant no. 51/1, 52/2, Phase I and II Industrial Estate ,
Hattar, Pakistan
Brand Name +Dosage Form + Nebron Tablet 2.5mg
Strength
Nebivolol as HCl………..2.5mg
Diary No. Date of R& I & fee Diary No:3056, 23/01/2018, Rs: 20,000/- Dated
22/01/2018
Pharmacological Group Beta blocking agents, selective
(C07AB12)
Type of Form Form 5
Finished product Specification Not claimed
Pack size & Demanded Price 2x7’s , Alu Alu Blister, As per SRO
Approval status of product in Bystolic
Reference Regulatory Authorities USFDA Approved
Nebil 2.5mg Tablet
M/s Getz Karachi

GMP status Last GMP inspection was conducted on 27-06-2018
and the report concludes good level of GMP
compliance.
Remarks of the Evaluator V • The applied formulation is available as
uncoated in MHRA and USFDA while the
firm has applied as film-coated tablet.
• No USP or BP monograph is available for the
applied formulation.
th
Decision of M-289 : Deferred for revision of formulation to uncoated tablet as per reference
product along with submission of fee for revision of formulation.
Evaluation by PEC: Firm has revised its formulation from coated to uncoated tablet with
submission of Rs 7500/- .
Registration letter will be issued after submission of Rs. 7,500 for reference of product
Hattar, Pakistan
Brand Name +Dosage Form + Nebron Tablet 5mg
Strength
Nebivolol as HCl………….5mg
22/01/2018
(C07AB12)
Type of Form Form 5
Pack size & Demanded Price 2x7’s , AluAlu Blister, As per SRO
Nebil 5mg Tablet
M/s Getz Karachi
and thereport concludes good level of GMP
compliance.
Remarks of the Evaluator XIII • The applied formulation is available as
• No USP or BP monograph is available for
the applied formulation.
th
submission of Rs 7500/-
Hattar, Pakistan

Brand Name +Dosage Form + Nebron Tablet 10mg
Strength
Nebivolol as HCl………..10mg
22/01/2018
(C07AB12)
Type of Form Form 5
Pack size & Demanded Price 2x7’s , AluAlu Blister, As per SRO
Nebil 5mg Tablet
M/s Getz Karachi
and thereport concludes good level of GMP
compliance.
Remarks of the Evaluator XIII • The applied formulation is available as
• No USP or BP monograph is available for
the applied formulation.
th
submission of Rs 7500/-
391. 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 + Zagrid Tablet 40mg
Strength
Febuxostat….40mg
Diary No. Date of R& I & fee Dy. No. 152, 16-06-2015 , Rs.20,000/- (16-06-2015)
Pharmacological Group Xanthine oxidase inhibitor
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price 1x10’s: Alu-Alu Blister: As per SRO
Approval status of product in Film coated tablets
Reference Regulatory Authorities. (USFDA, MHRA Approved)
Me-too status Degouric by Atco
GMP status Last inspection conducted on 27-02-2017“Strictly
following the GMP compliance.”
Remarks of the Evaluator. The formulation is uncoated tablet while the product
approved by reference regulatory authorities is film
coated tablet.

Previous Meeting (M-274) Deferred for the clarification of dosage form as
reference product is available as film coated tablet
whereas firm has applied for uncoated tablet.
Evaluation by PEC Firm has revised their formulation as per innovator.
Decision: Deferred for submission of fee as the firm has revised the formulation.
Evaluation by PEC: Firm has revised its formulation from uncoated to coated tablet with
submission of Rs 7500/- .
Registration letter will be issued after submission of Rs. 7,500/- for correction in
2021.
Agenda of Evaluator PEC-VI
Case no. 01 Registration applications for local manufacturing of (Human) drugs (Form
5)
New cases
392. Name and address of M/s Jenner Pharmaceuticals (Pvt.) Ltd. Plot # 03, M-2
manufacturer / Applicant Pharmazone 26- km Lahore Sharaqpur Road
Sheikhupura
Brand Name +Dosage Form + Fluzole Capsules 150mg
Strength
Fluconazole: 150mg
Diary No. Date of R& I & fee Dy:35107, 23-10-2018 , Rs.20,000/- (22-10-2018)
Pharmacological Group Antifungal, Triazole derivatives
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price 1’s As per SRO
Me-too status Conza Capsule, De-Mont Research Labs., Reg. No.
084049
GMP status Last GMP/Panel inspection conducted on 23-12-2020
for renewal of DML
Remarks of the Evaluator. M/s Jenner Pharmaceutical was established at address
“Plot # 3, M-2, Pharmazone 26th km Lahore Sharqpur
Road, Sheikhupura” but on Drug Manufacturing License
it was mentioned as “Plot # 2, M-2, Pharmazone 28th km
Lahore Sharqpur Road, Distt. Sheikhupura”
The firm have applied for correction on DML through
letter No. JEN/DRAP/034/2017 dated 30-11-2019 and got
approval of correction of address through letter No.
F.1.18/2009-Lic dated 12 November 2020.
Decision: Approved.

b. Deferred cases
393. M/s Glitz Imipra 75mg Form 5 International Decision of
Pharma, Plot Tablets 12-08-2014 Availability 263rd:
No. 265, Each tablet Dy.No.3286 not provided Deferred for
Industrial contains: - Rs.8000/= evidence of
Triangle Imipramine Rs. 12,000/= Local approval of
Kahota Road HCl ……. 11-10-2010 Availability: applied
Islamabad 75mg 1x10’s Tornal by formulation &
(USP Specs.) 2x10’s M/s Novartis strength in
3x10’s pharma reference
5x10’s Pakistan regulatory
5x20’s authorities
10x10’s Last
25x10’s inspection
20x20’s report of 10-
50x10’s 02-2016
As Per SRO submitted
with
compliance
remarks
Evaluation: The firm has revised the strength from 75mg to 10mg tablet as below:
Each tablet contains
Imipramine HCL…..10mg
The firm has submitted fee of Rs.7500 only Deposit 9750728723 dated 8 March 2022.
The firm did not submit revised form 5 .
GMP certificate valid till 2023.
Decision: Approved. The firm shall submit fee of Rs. 30,000/- for correction/pre-
approval change in product strength as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021 along with submission of complete form 5 for revised composition.
394. M/s Glitz Palidone XR Form 5 Invega Deferred for
Pharma, Plot 9mg Tablets 13-02-2015 prolong evidence of
No. 265, Each extended Dy.No.937 release me-too status
Industrial release tablet Rs.8000/= tablets-
Triangle contains:- Rs.12,000/= MHRA
Kahota Road Paliperidone 19-06-2012
Islamabad ………… 9mg 1x10’s Local
(Psychotropic 2x10’s Availability:
agent belonging 3x10’s Invega 9mg
to the chemical 5x10’s Tablrts by
class of 10x10’s M/s Johnson
benzisoxazole 20x10’s & Johnson
derivatives. 50x10’s Pharma,
Recemic 100x10’s Pakistan
mixture of (+)- As Per SRO
and (-)- Last
paliperidone) inspection
(Manufacturer’s report of
Specs) 10-02-
2016
submitted
with
complianc
e remarks
Evaluation:

The firm has revised the strength from Paliperidone XR 9mg to Paliperidone XR 1.5mg as
below:
Palidone XR (Palinode XR)
Each extended release tablet contains:
Paliperidone…. 1.5mg
The firm has submitted fee of Rs.7500 only Deposit 4805777154 dated 8 March 2022.
The firm did not submit revised form5.
Decision: Deferred for confirmation of manufacturing requirements as per reference
product.
395. M/s Glitz Mac-5 Tablets Form 5 Singulair by Decision of
Pharma, Plot Each tablet 12-08-2014 Merck sharp 263rd
No. 265, contains:- Dy.No.3285 and DOHMI Deferred for
Industrial Montelukast Rs.8000/= corporation change of
Triangle Sodium …….. Rs.12,000/= USA, formulation
Kahota Road 5mg 24-11-2010 Aerotel of as per
Islamabad ( 2x7’s M/s innovator.
Antiasthmatic 20x7’s Highnoon
) As Per SRO Labs
Last
inspection
report of 10-
02-2016
submitted
with
compliance
remarks
Evaluation: The firm has revised the formulation from plain tablet 5mg to chewable
tablet 5mg as below
Each chewable tablet contains:
Montelukast as sodium…5mg
Inhouse specification
They have submitted revised form 5 but did not submit fee.
Decision: Approved with USP specifications. The firm shall submit fee of Rs. 30,000/-
for correction/pre-approval change in product dosage form as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021 along with submission of complete form 5 for
revised composition.
396. Name and address of Glitz Pharma, Plot No 265, Industrial Triangle,
manufacturer / Applicant Kahuta Road Islamabad
Brand Name +Dosage Form + Memanta 10mg/5ml Syrup
Strength
Diary No. Date of R& I & fee Dy. No.1413 , R&I Dated 31-10-14 , Rs: 20,000/-
Composition Each 5ml contains:-
Memantine HCl ……..10mg
Pharmacological Group (Anti-Parkinson)
Type of Form From 5
Pack size & Demanded Price 60ml,90ml,120ml,240ml,300ml, Amber glass bottle, As
per policy of MOH

Approval status of product in
Reference Regulatory Memantine Sandoz 10mg/ml (MHRA)
Authorities.
Me-too status Zexa by English Pharm, Lahore (R. No. 071544)
GMP status GMP inspection Date: 29-11-2016, GMP status is not
clear.
Remarks of the Evaluator. I. The evidence provided for liquid syrup section
is of 2005.
II. 251st meeting commitment not provided by the
firm.
III. Incorrect pharmacological group provided by
firm.
IV. Incorrect International availability provided by
firm.
Decision of 270th: Deferred for the following reasons:
Confirmation of approval status by reference regulatory authorities.
Clarification of pharmacological group.
Submission of commitments as per decision of Registration board taken in its 251st
meeting.
Clarification of pharmacopoeial reference.
Evaluation: The firm has submitted pharmacological group: NDMA receptor antagonists
or used to treat dementia.
USP specification.
International reference could not be confirmed.
Commitments did not submit
Decision: Deferred for evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the Registration Board in its
275th meeting.
397. Name and address of manufacturer / M/s Glitz Pharma, Plot No. 265,
Applicant Industrial Triangle Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength Gynezol 1.0% w/w Cream
Composition Each gram contains:
Isoconazole Nitrate………….1% w/w
Diary No. Date of R& I & fee Dy. No. 1433: 19-10-2015
PKR 20,000/-: 16-10-2015
Pharmacological Group (Antifungal for topical use)
Type of Form Form 5
Finished product Specifications Firm has claimed in house specifications
Pack size & Demanded Price 10gm, 40gm: As per SRO
Approval status of product in Reference Could not be confirmed
Me-too status Ispgen by Shrooq
GMP status Last inspection report dated 29-11-2016 do
not have any conclusion and remarks
regarding GMP status
Remarks of the Evaluator • Evidence of approval of applied
formulation in reference regulatory
authorities could not be confirmed
Decision of 273th :
Deferred for following submissions
• Comments of QA & LT Division regarding the GMP status of the firm
• Evidence of approval in reference regulatory authorities

Evaluation: The firm has submitted GMP certificate valid till 2023.
275th meeting.
398. Name and address of manufacturer / M/s Glitz Pharma, Plot No. 265,
Applicant Industrial Triangle Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength Trimax cream
Composition Each gram contains
Flucinolone acetonide……..0.01% w/w
Hydroquinone……………..4.0% w/w
Tretinoin…………………..0.05% w/w
Diary No. Date of R& I & fee Dy No. 1807: 3-11-2015
PKR 20,000/-: 2-11-2015
Pharmacological Group Antiinflammatory and antipruritic drug
Type of Form Form 5
Finished product Specifications Firm has claimed in house specifications
Pack size & Demanded Price 10g, 15g, 20g, 40g: As per SRO
Approval status of product in Reference Could not be confirmed
Me-too status Trimelasin cream by Valor
GMP status Last inspection report dated 29-11-2016 do
not have any conclusion and remarks
regarding GMP status
Remarks of the Evaluator Evidence of approval of applied formulation
in reference regulatory authorities could not
be confirmed
Decision of 273th :
Deferred for following submissions
• Comments of QA & LT Division regarding the GMP status of the firm
• Evidence of approval in reference regulatory authorities
Evaluation: The firm has submitted GMP certificate valid till 2023.
275th meeting.
399. Name and address of manufacturer M/s Zafa Pharmaceuticals Laboratories Private
/ Applicant Limited. L-1/B, Block-22, Federal B industrial
Area, Karachi
Brand Name +Dosage Form + Zodip-V Plus 5/160/12.5 mg Tablet
Strength
Valsartan…160mg
23.07.2018
Pharmacological Group Antihypertensive
Type of Form Form-5
Approval status of product in EXFORGE HCT® Tablets. US-FDA approved
Me-too status Exforge HCT 5/160/12.5MG film coated tablets. Reg.
No. 69548

GMP status GMP certificate was issued based on inspection
conducted on 29 october 2020.
Remarks of the Evaluator (VI) The firm had mentioned amlodipine in label claim.
In the revised Form 5, they corrected it to amlodipine
as besylate in
master formula.
However, it was ‘amlodipine as besylate’ in Master
formula.
The firm did not revise it to amlodipine besilate.
The firm has mentioned coating composition in
Master formula. However, the label claim was “each
tablet contains”. The firm revised ‘Each tablet
contains’ to ‘Each film-coated tablet contains’ in
Form 5.
Blistering/packaging process is missing in the
manufacturing
outlines
Decision of 291th : Deferred for the following:
Revision of ‘amlodipine as besylate’ to ‘amlodipine besylate’ in Master formula
Submission of complete manufacturing outlines.
Evaluation by PEC (VI): The firm has revised their formulation as:
Amlodipine besylate eq. to Amlodipine…5mg
Valsartan…160mg
Without submitting any correction fee.
Decision: Approved. Firm shall submit fee of Rs. 30,000/= for correction/pre-approval
change/ in label claim and composition, as per notification No.F.7-11/2021-B&A/DRAP
dated 13-07-2021.
/ Applicant Limited.
L-1/B, Block-22, Federal B industrial Area,
Karachi
Brand Name +Dosage Form + Zodip-V Plus 10/160/12.5 mg Tablet
Strength
Valsartan…160mg
23.07.2018
Type of Form Form-5
Me-too status Exforge HCT 10/160/12.5MG film coated tablets.
Reg. No. 69550
GMP status GMP certificate issued on 23.05.2018
as besylate in
master formula.

formula.
Form 5.
manufacturing
outlines
Decision of 291th : Deferred for the following:
Amlodipine besylate eq to Amlodipine…10mg
Valsartan…160mg
Decision: Approved. Firm shall submit fee of Rs. 30,000/= for correction/pre-approval
dated 13-07-2021.
/ Applicant Limited.
L-1/B, Block-22, Federal B industrial Area,
Karachi
Brand Name +Dosage Form + Zodip-V Plus 10/160/25 mg Tablet
Strength
Valsartan…160mg
23.07.2018
Type of Form Form-5
Me-too status Exforge HCT 10/160/25MG film coated tablets. Reg.
No. 69551
GMP status GMP certificate issued on 23.05.2018
as besylate in
master formula.
formula.

Form 5.
manufacturing
outlines
th
Decision of 291 : Deferred for the following:
Amlodipine besylate eq to amlodipine…10mg
Valsartan…160mg
Decision: Approved. Firm shall submit fee of Rs. 30,000/ for correction/pre-approval
dated 13-07-2021.
402. Name and address of manufacturer M/s Linta Pharmaceuticals Pvt Ltd. Plot No. 03,
/ Applicant Street No S-5, National Industrial Zone, Rawat,
Islamabad"
Brand Name +Dosage Form + Micolin Oral Gel 2.0% Dakrin, Micono.
Strength
Composition Each gram of Gel Contains: Miconazole Nitrate eq.
to Miconazole…20mg
Diary No. Date of R& I & fee Dy.No 21762 dated 21-06-2018 Rs.20,000/- 21-06-
2018 Rs. 5000/- for change of formulation
Pharmacological Group Antifungals For Topical Use D01AC02
Type of Form Form-5
Finished product Specification BP
Pack size & Demanded Price As per SRO, Alu tubes of 15g and 30g
Approval status of product in Daktarin (Miconazole 2% w/w). MHRA Approved
Me-too status Mogel 20mg/g Oral Gel by M/s Sigma Pharma (Reg
no.
079910)
GMP status 12-06-2018, GMP Compliant.
Remarks of the Evaluator (VI) The reference formulation contains miconazole
without nitrate salt
th
Decision of 291 : Deferred for revision of formulation as per the reference product along
with submission of fee for revision of formulation.
Evaluation by PEC VI:
Firm has submitted as : Micolin Oral Gel 2% Each gram of gel contains: Miconazole Nitrate
eq to Miconazole….20mg
Decision of 316th : Deferred for evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the Registration Board in its 275th
meeting.
Evaluation by PEC-VI: The firm has corrected formulation without submission of fee as:
Each gram of Gel Contains: Miconazole…20mg
Decision: Approved. Firm shall submit the fee of Rs. 30,000 for correction/pre-approval
change in composition (correction/change of salt form of the drug substance), as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021. Registration letter will be
issued upon confirmation of availability of required manufacturing facility for applied
dosage form.

Case no. 08 Registration applications of import (Human) drugs on Form 5F
b. Deferred cases
403. Name, address of Applicant / M/s Medical Equipment & System 60/61 FCC,
Importer Syed Maratib Ali Road, Gulberg IV District
Lahore, Pakistan
Details of Drug Sale License of License No: 05-352-0065-069537D
importer Address: House No 59-C/III, Gulberg III District
Lahore
Validity: 14-04-2-23
Renewal: Firm has submitted a receipt of renewal
but it does not contain any date
Name and address of marketing M/s Guerbet
authorization holder (abroad) BP 57400,F-95943 Roissy CdG Cedex
Name, address of manufacturer(s) M/s Guertbet
BP 57400,F-95943 Roissy CdG Cedex
(Responsible for manufacturing and Batch
releasing)
Name of exporting country France
Detail of certificates attached CoPP: Firm has submitted original, legalized copy
(CoPP, Freesale certificate, GMP of CoPP certificate (No. 034191) dated 23-06-2020
certificate) issued CCI PARIS ILE-DE-FRANCE for Lipiodol
Ultra Fluide(480mg I/ml) solution injectable . The
CoPP confirms free sale status of the product in
exporting country as well as GMP status of the
every year.
mentioned as France. Furthermore the CoPP
was valid till 22-06-2022.
Details of letter of authorization / Firm has submitted copy of letter of distribution
sole agency agreement certificate from. The letter species that the
manufacturer appoints M/s Medical Equipment &
System register their products in Pakistan. The
authorization letter is valid till 11-04-2023.
☒ Importer
purpose only

Dy. No. and date of submission Form-5F Dy. No. 22519: 1-07-2021
The proposed proprietary name / LIPIODOL Injection 10ml
brand name
Strength / concentration of drug of Each 10ml of ampoule contains:4800mg of iodine
Active Pharmaceutical ingredient Lipiodol in the form of ethyl ester of iodised fatty
(API) per unit acids of poppy seed oil contains 48% w/v 480mg of
iodine per ml)
Pharmaceutical form of applied White lyophilized mass packed in moulded amber
drug type-I vials.
Pharmacotherapeutic Group of Non-water-soluble x-ray contrast media
(API)
specifications
The status in reference regulatory Injection (USFDA Approved).
authorities
For generic drugs (me-too status) Not applicable as it is an innovator product
Summary) template. Firm has summarized information related
Name, address of drug substance Manufacture: M/s SIMAFEX
manufacturer Address: 16 avenue des Fours a Chauz MARANS,
17230 France
(Conditions & duration of Stability of API at accelerated as well as real time conditions.
studies) The real time stability data is conducted at 5oC ±
3oC. The stability study data is till 36 months.

Pharmaceutical Equivalence and Not submitted as The product is innovator.
Container closure system of the drug USP type-I glass
product
Stability study data of drug product, Firm has submitted stability study data of 3 batches
shelf life and storage conditions The accelerated stability study data is conducted at
40oC ±2oC / 75% ± 5% RH for 6 months. The real
time stability study data is conducted at 30oC ±2oC /
75% ± 5% RH. The real time stability study data of
2 batches is for 12 months while the stability study
data for 3rd batch is for 9 months only.
Evaluation by PEC VI:
Sr Short coming Reply
no
1 • Different API and finish product The firm has submitted valid GMP certificate
manufacturers are written in your of M/s Guerbet 16-24 rue Jean Chaptal, Aulnay
application. Please specify the Sous Bois, 93600, France issued by
one which is actually EudraGMP. Valid till 2024
manufacturing API and finish The firm has submitted valid GMP certificate
product. Also submit valid GMP of M/s Simafex 16, Avenue des Fours a Chaux,
certificate of both manufacturers. Marans, 1720, France issued by EudraGMP.
Valid till 2024
2 • Letter of authorization/agreement Similar product was considered in M-291st
is required clearly showing the meeting in September 2019 from
validity. Applicant: M/s A & Z Health Services. Suit
No. 2, Block 27, Industrial &
Trade Center, G-9/4, Islamabad, Pakistan.”
MAH: M/s Guerbet BP 57400, F-95943,
Roissy CdG CEDEX"
Brand name: Lipiodol Ultra-Fluide (480mg
I/ml) Solution for Injection
3 • 3.2.S.4 Control of Drug Substance
/3.2.P.5 Control of Drug Product.
You are following In-house
specifications, although the
product is present in
pharmacopoeia. Justification is
required.

Decision of 316th : Deferred for clarification regarding sole agency agreement of applied
product since same product was considered in 291st meeting of Registration Board from
applicant M/s A & Z Health Services. Suit No. 2, Block 27, Industrial & Trade Center, G-9/4,
Islamabad, Pakistan.”
Evaluation by PEC VI: M/s Medical equipment and systems has submitted NOC from M/s A
& Z . The NOC states “We M/s : A&Z health services, Suit #2, Block 27 I&T center, G-9/4
Islamabad do hereby state and undertake that we have no objection if the product LIPIDOL
ULTRA FLUID register on the name M/s Medical Equipment & Systems 60/61, FCC Syed
Maratib Ali Road, Gulberg IV Lahore.”
Decision: Deferred for further deliberation upon marketing status of the applied product.
404. Name, address of Applicant / M/s Ahsan Pharma Room no.2 Delhi Muslim
Importer Building Aram Bagh Road, Karachi
importer Address: Room no.2 Delhi Muslim Building Aram
Bagh Road, Karachi.
Address of Godown: B-4, S.I.T.E. Karachi
Name and address of marketing M/S Seacross Pharmaceutical Co., Ltd, Stanmore
authorization holder (abroad) Place Howard Road, Stanmore London HA7 1BT,
UK
Product Licence/Marketing Authorization holder

SEACROSS PHARMACEUTICALS LIMITED
BEDFORD BUSINESS CENTRE,
61 - 63 ST.PETER’S STREET, BEDFORD,
BEDFORDSHIRE,
MK40 2PR, UNITED KINGDOM
M/s Sichuan Huiyu Pharmaceutical Ltd. No. 5 Road
Chengxi economic area, Neijiang, Sichuan-641000,
China. (GMP is issued by CFDA and is valid until
27/5/2023)
Batch Release Site:
Seacross Pharmaceutical Co., Ltd Stanmore Place,
Suite 205, Howard Road, Stanmore HA7 1BT,
United Kingdom
Manufacturer Licence Holder:
United Kingdom
Detail of certificates attached (CoPP, CoPP: the firm has submitted CoPP from MHRA for
Freesale certificate, GMP certificate) Doxorubicin 2mg/ml Concentrate for Solution for
Infusion, Certificate No: PP10165864 dated 03-Apr-
2020. The firm has submitted copy of letter from
MHRA regarding issuance of export certificates for
medicines for humans which will not be available as
hard copy with wet ink signature during the period
pertaining to COVID-19
“The export certificate will be processed by the
MHRA named signatories and issued as electronic
pdf copy. The certificate will refer to this covering
letter which should be attached to any submissions.”
Details of letter of authorization / sole Firm has submitted Copy of Exclusive Distribution
agency agreement Agreement is submitted M/S Seacross
Pharmaceutical Co., Ltd Stanmore Business &
Innovation Centre, Stanmore Place Howard Road,
Stanmore London HA7 1BT, UK authorizes M/s
Ahsan Pharma Room no.2 Delhi Muslim Building
Aram Bagh Road, Karachi for marketing and selling
the Seacross products including the applied product.
☒ Importer

purpose only
The proposed proprietary name / Doxorubicin 2mg/ml Concentrate for Solution for
brand name Infusion,
Strength / concentration of drug of Each 5ml vial contains:
Active Pharmaceutical ingredient Doxorubicin hydrochloride…….10mg
(API) per unit
Pharmaceutical form of applied drug Concentrate for Solution for infusion
Pharmacotherapeutic Group of (API) Anthracyclines and related substance (L01DB01)
Reference to Finished product BP
specifications
Proposed Pack size 5ml x 1’s
authorities Each 5ml vial contains 10 mg of Doxorubicin
hydrochloride. Concentrate for solution for infusion
Name, address of drug substance M/s Sterling Biotech Ltd Jambusar State Highway
manufacturer Taluka Padra, District Vadodara India-391 421
Masar Village, Gujarat
Module-III Drug Substance: Firm has submitted
(EDQM has issued certificate of suitability which is
deemed to replace the data. )
Stability Studies of Drug Substance (EDQM has issued certificate of suitability which is
(Conditions & duration of Stability deemed to replace the data. )
studies)

Pharmaceutical Equivalence and Pharmaceutical Equivalence has been compared with
Comparative Dissolution Profile Adriblastina (Greece), Adriamycin (Denmark,
Australia).
Container closure system of the drug Type-I glass vial
product
Stability study data of drug product, 2 months accelerated studies at 25C, 60% has been
shelf life and storage conditions submitted. Long term stability studies at 5C for
18months has been submitted.
Storage temperature is 2 to 8C.
Evaluation by PEC:
Sr no Short Coming Replies
1 The address of manufacturer on GMP M/s Sichuan Huiyu changed the address as per
and COPP is different. Clarification is requirements from local official administrative office.
needed. The CPP was applied before the address changed.
However, the Eudra has updated the GMP to the
current address, and the GMP certificate number is
also updated to 0004 from 0003 version.
2 GMP certificates of M/s Seacross Did not provided.
Pharmaceuticals and M/s Sterling
Biotech Ltd Jambusar are required.
3 3.2.P.8 You have provided The product is thermal sensitive. The impurity
Accelerated stability data for only 2 content and assay were out of specification at 2nd
months. Remaining months data is not month of accelerated stability study, so the storage
provided. condition of the product should be at 2~8℃. The
product should be transferred on a controlled
temperature during shipping. The shelf life is based
on the long-term stability study.
2 months accelerated studies at 25C, 60% has been

submitted. Long term stability studies at 5C for
4 3.2.P.5.3 Validation of analytical The full validation reports, including specificity,
procedures: For in-house methods, repeatability and accuracy, for assay, degradation and
analytical methods validation shall be related substance will be provided by you tomorrow.
performed. All the officially
recognized compendial methods for
assay, dissolution and impurities (as
applicable) are required to be verified
and verification shall include a
demonstration of specificity,
repeatability (method precision) and
accuracy
Decision of 312th : Deferred for submission of complete stability study data of finished product as
per Zone -IVA.
Evaluation by PEC: The firm has submitted MHRA COPP and Smpc that states “Store at 2 to 8
‘C”. They also submitted declaration letter from the manufacturer “Doxorubicin is a thermal sensitive
product, required to be stored in a refrigerator. The long-term stability study condition according to
ICH Q1 is 2 to 8, which has been provided. It is not necessary to provide 30’C stability data for
Doxorubicin, as significant change has occurred at 2nd month at 25 ‘C condition.”

Decision of 320th meeting: Approved as per Policy for inspection of Manufacturer abroad and
verification of local storage facility.
405. Name, address of Applicant / M/s Ahsan Pharma Room no.2 Delhi Muslim
Importer Building Aram Bagh Road, Karachi
importer Address: Room no.2 Delhi Muslim Building Aram
Bagh Road, Karachi.
Address of Godown: B-4, S.I.T.E. Karachi
Name and address of marketing M/S Seacross Pharmaceutical Co., Ltd, Stanmore
authorization holder (abroad) Place Howard Road, Stanmore London HA7 1BT,
UK
Product Licence/Marketing Authorization holder
SEACROSS PHARMACEUTICALS LIMITED
BEDFORD BUSINESS CENTRE,
61 - 63 ST.PETER’S STREET, BEDFORD,
BEDFORDSHIRE,
MK40 2PR, UNITED KINGDOM
M/s Sichuan Huiyu Pharmaceutical Ltd. No. 5 Road
Chengxi economic area, Neijiang, Sichuan-641000,
China(GMP is issued by CFDA and is valid until
27/5/2023)
Batch Release Site:
United Kingdom
Manufacturer Licence Holder:
United Kingdom
Detail of certificates attached (CoPP, CoPP: the firm has submitted CoPP from MHRA for
Freesale certificate, GMP certificate) Doxorubicin 2mg/ml Concentrate for Solution for
Infusion, Certificate No: PP10165864 dated 03-Apr-
2020. The firm has submitted copy of letter from
MHRA regarding issuance of export certificates for
medicines for humans which will not be available as
hard copy with wet ink signature during the period
pertaining to COVID-19
“The export certificate will be processed by the
MHRA named signatories and issued as electronic
pdf copy. The certificate will refer to this covering
letter which should be attached to any submissions.”
Details of letter of authorization / sole Firm has submitted Copy of Exclusive Distribution
agency agreement Agreement is submitted M/S Seacross
Pharmaceutical Co., Ltd Stanmore Business &
Innovation Centre, Stanmore Place Howard Road,
Stanmore London HA7 1BT, UK authorizes M/s
Ahsan Pharma Room no.2 Delhi Muslim Building
Aram Bagh Road, Karachi for marketing and selling
the Seacross products including the applied product.

☒ Importer
purpose only
The proposed proprietary name / Doxorubicin 2mg/ml Concentrate for Solution for
brand name Infusion,
Strength / concentration of drug of Each 25ml vial contains:
Active Pharmaceutical ingredient Doxorubicin hydrochloride…….50mg
(API) per unit
Pharmaceutical form of applied drug Concentrate for Solution for infusion
Pharmacotherapeutic Group of (API) Anthracyclines and related substance (L01DB01)
Reference to Finished product B Pharmacopoeia
specifications
Proposed Pack size 25ml x1’s
authorities
Name, address of drug substance Sterling Biotech Ltd Jambusar State Highway Taluka
manufacturer Padra, District Vadodara India-391 421 Masar
Village, Gujarat
Module-III Drug Substance: Firm has submitted
(EDQM has issued certificate of suitability which is
deemed to replace the data. )
Stability Studies of Drug Substance (EDQM has issued certificate of suitability which is
(Conditions & duration of Stability deemed to replace the data. )
studies)

Pharmaceutical Equivalence and Pharmaceutical Equivalence has been compared with
Comparative Dissolution Profile Adriblastina (Greece), Adriamycin (Denmark,
Australia).
Container closure system of the drug Type-I glass vial
product
Stability study data of drug product, 2 months accelerated studies at 25C, 60% has been
shelf life and storage conditions submitted. Long term stability studies at 5C for
Evaluation by PEC:
Sr. Short Coming Replies
no
1 The address of manufacturer on GMP M/s Sichuan Huiyu changed the address as per
and COPP is different. Clarification is requirements from local official administrative office.
needed. The CPP was applied before the address changed.
However, the Eudra has updated the GMP to the
current address, and the GMP certificate number is
also updated to 0004 from 0003 version.
2 GMP certificates of M/s Seacross Did not provided.
Pharmaceuticals and M/s Sterling
Biotech Ltd Jambusar are required.
3 3.2.P.8 You have provided The product is thermal sensitive. The impurity
Accelerated stability data for only 2 content and assay were out of specification at 2nd
months. Remaining months data is not month of accelerated stability study, so the storage
provided. condition of the product should be at 2~8℃. The
product should be transferred on a controlled
temperature during shipping. The shelf life is based
on the long-term stability study.
2 months accelerated studies at 25C, 60% has been

submitted. Long term stability studies at 5C for
4 3.2.P.5.3 Validation of analytical The full validation reports, including specificity,
procedures: For in-house methods, repeatability and accuracy, for assay, degradation and
analytical methods validation shall be related substance will be provided by you tomorrow.
performed. All the officially
recognized compendial methods for
assay, dissolution and impurities (as
applicable) are required to be verified
and verification shall include a

demonstration of specificity,
repeatability (method precision) and
accuracy
Decision of 312th: Deferred for submission of complete stability study data of finished product as
per Zone -IVA.
Evaluation by PEC: The firm has submitted MHRA COPP and Smpc that states “Store at 2 to 8
‘C”. They also submitted declaration letter from the manufacturer “Doxorubicin is a thermal sensitive
product, required to be stored in a refrigerator. The long-term stability study condition according to
ICH Q1 is 2 to 8, which has been provided. It is not necessary to provide 30’C stability data for
Doxorubicin, as significant change has occurred at 2nd month at 25 ‘C condition.”
Decision of 320th meeting: Approved as per Policy for inspection of Manufacturer abroad and
verification of local storage facility.
Case no. 03 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
b. Deferred Cases
406. Name and address of manufacturer/ M/s Bio-Oxime Pharmaceuticals Plot.no.31,32 Millat Garment
Applicant City, Dry Port Road, Faisalabad
Brand Name + Dosage Form + Biostin Oral Powder
Strength
Colistin Sulphate…500,000IU
Diary No. Date of R & I & fee Dy. No. 7971; 22.02.2019
PKR. 20,000/-; 22.02.2019
Pharmacological Group Antibiotics
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications
Pack size & Demanded Price Decontrolled
Me-too status Could not be confirmed
GMP status The firm was inspected on 24.02.2021, wherein the renewal of
DML was recommended.
Remarks of the Evaluator • Provide proof of approval of me-too product (name and
registration number) approved by DRAP.
Previous decision The board in its 295th meeting deferred the case for:
• Updated status of GMP since submitted inspection
report is not within the period of three years.
• Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) along with
• GMP status updated.
• The firm submitted me-too reference, which is not
matching with the applied product.
Decision of 312th : Deferred for evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) along with registration number, brand name and name of firm.
Evaluation: The firm has submitted me-too as:
Polyrox Forte water soluble powder.
Each 100gm contains:
Colistin Sulphate….500MIU by M/s Vetrox Pharmaceutcals.
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.

407. Name and address of manufacturer/ M/s Bio-Oxime Pharmaceuticals
Applicant Plot.no.31,32 Millat Garment City, Dry Port Road, Faisalabad
Brand Name + Dosage Form + Noflor Oral Powder
Strength
Composition Each gm contains:
Neomycin sulphate…150mg
Florfenicol…100mg
Oxytetracycline…300mg
PKR. 20,000/-; 22.02.2019
Type of Form Form 5
Pack size & Demanded Price 500g, 1000g, 5000g; Decontrolled
Me-too status E-COL WATER SOLUBLE POWDER. Reg. No. 81733
Previous decision The board in its 295th meeting deferred the case for updated
status of GMP since submitted inspection report is not within
the period of three years.
• In the latest database, the me-too product contains
Oxytetracycline HCl…300mg instead of
Oxytetracycline…300mg.
Decision of 312th : Deferred for revision of salt form along with submission of applicable fee.
Evaluation: The firm has submitted fee of Rs 7500 slip no 5132746736 and revised formulation with
the addition of HCL as:
Each gm contains:
Neomycin sulphate…150mg
Florfenicol…100mg
Oxytetracycline HCl…300mg
E-COL WATER SOLUBLE POWDER. Reg. No. 81733
Decision: Approved with Innovator specifications. Firm shall submit the differential fee of Rs.
22,500/- for correction/pre-approval change in composition (correction/change of salt form of the
drug substance), as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
408. Name and address of manufacturer/ M/s Bio-Oxime Pharmaceuticals
Applicant Plot.no.31,32 Millat Garment City, Dry Port Road, Faisalabad
Brand Name + Dosage Form + Speclin 100 Oral Liquid
Strength
Lincomycin HCL…33.3
Spectinomycin HCL…66.7gm
PKR. 20,000/-; 22.02.2019
Type of Form Form 5
Pack size & Demanded Price Decontrolled
Me-too status LINCO-S 100 W/S POWDER. Reg. No. 62169
Remarks of the Evaluator • Submit latest GMP inspection report.

• You have applied for liquid pack size. Justify.
• Revise Lincomycin HCl to Lincomycin as HCl
and Spectinomycin HCl to Spectinomycin as HCl. Also,
adjust their weight in master formula as per salt factor.
Previous decision The board in its 295th meeting deferred the case for:
• Updated status of GMP since submitted inspection
report is not within the period of three years.
• Revision of formulation as per me-too reference
• Confirmation of pack size
• The firm revised Lincomycin HCl to Lincomycin as
HCl
and Spectinomycin HCl to Spectinomycin as HCl, but
did not adjust their weight in master formula as per salt
factor.
• The firm claimed 150g, 500g, and 1000g pack size.
Decision of 312th: Deferred for adjustment of weights of APIs in master formula as per salt factor.
Along with submission of applicable fee.
Evaluation: The firm has adjusted the weigh in master formulation and deposited fee Rs 7500 slip no
8755481265.
Decision: Approved with Innovator specifications. Firm shall submit the differential fee of Rs.
22,500/- for correction/pre-approval change in composition (correction/change of salt form of the
drug substance), as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
409. Name and address of M/s Eterna Pharma (Pvt.) Ltd. Plot#
manufacturer / Applicant (99,100,101,198)C, Sector D1,Old Industrial Estate,
Mirpur,Azad Jammu & Kashmir.
Brand Name+Dosage DI-BP Benz Injection (10ml)
Form+Strength
Composition Each ml contains:-
Benzathine Penicillin G …100,000IU
Procaine Penicillin …15,000IU
Streptomycin sulphate …200mg
Diary No. Date of R& I & fee Dy No: 31176, Dated:12-11-2021, Rs. 30,000,
Dated:11-11-2021
Type of Form Form 5
Finished Product Specification Manufacturer’s Specification
Pack size & demanded price 10ml/ Decontrolled
Me-too status B.G Probenz Injection
REG.# 072699
Biogen Pharma,Rawat.
GMP status The Central Licensing Board in its 283rd meeting held
on 28th October,2021 has considered and approved the
four (04) additional sections in the name of M//s Eterna
Pharma (Pvt.)Ltd.Plot#(99,100,101,198)C,Sector
D1,Old Industrial Estate, Mirpur,Azad Jammu &
Kashmir by way of Formulation vide approval letter
No. F. 5-1/2016- Lic dated 11th November, 2021.
Remarks of the Evaluator • Me-too status not confirms from available database.
Composition of submitted me-too i.e B.G Probenz
Injection by M/s. Biogen Pharma,Rawat
(Reg#072699) is:

Each ml contains:-
Benzathine Penicillin G …100,000 IU
Procaine Penicillin G …150,000 IU
Dihydrostreptomycin Sulphate …200 mg
Decision of 316th : Deferred for evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) along with registration number, brand name and name of
firm.
Evaluation by PEC(VI):
Decision of 320th meeting: Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with registration number, brand
name and name of firm.
410. Name and address of M/s Eterna Pharma (
manufacturer / Applicant Pvt.)Ltd.Plot#(99,100,101,198)C,Sector D1,Old
Industrial Estate, Mirpur,Azad Jammu &
Kashmir.
Brand DI-BP Benz Injection (30ml)
Name+DosageForm+Strength
Dihydrostreptomycin sulphate …200mg
Dated:11-11-2021
Type of Form Form 5
REG.# 072699
four (04) additional sections in the name of M//s
Eterna Pharma
(Pvt.)Ltd.Plot#(99,100,101,198)C,Sector D1,Old
Industrial Estate, Mirpur,Azad Jammu & Kashmir by
way of Formulation vide approval letter No. F. 5-
1/2016- Lic dated 11th November, 2021.
(Reg#072699) is:
Each ml contains:-
firm.

Kashmir.
Dated:11-11-2021
Type of Form Form 5
REG.# 072699
Eterna Pharma
(Reg#072699) is:
Each ml contains:-
th
Decision of 316 : Deferred for evidence of applied formulation/drug already approved by
firm.
Kashmir.
Dated:11-11-2021

Type of Form Form 5
REG.# 072699
Eterna Pharma
(Reg#072699) is:
Each ml contains:-
th
firm.
Kashmir.
Brand Brom-CTD Water Soluble Powder
Composition Each gm contains: -
Doxycycline HCl ….100 mg
Tylosin Tartrate …100 mg
Colistin Sulphate …25, 00,000 IU
Bromhexine HCl …5mg
Diary No. Date of R& I & fee Dy.No:31088 , dated:12-11-2021, Rs.30,000/-,
dated: 11-11-2021
Pharmacological Group Antibiotic, Mucolytic
Type of Form Form 5
Pack size & demanded price 100gm,500gm,1 Kg,5Kg,10Kg, 25Kg./ Decontrolled
Approval status of product in N/A
Me-too status DOXIMAC-C WATER SOLUBLE POWDER
REG.#049530
PRIX PHARMACEUTICA (PVT) LTD., LAHORE.
GMP status GMP inspection held on 14-10-2021
Panel Inspection

Panel recommended the approval of 4 additional
sections
Remarks of the Evaluator Firm has applied Doxycycline HCl ….100 mg,
whereas, me-too contains Doxycycline Hyclate
….100 mg.
th
firm.
414. Name and address of M/s Eterna Pharma
manufacturer / Applicant (Pvt.)Ltd.Plot#(99,100,101,198)C,Sector D1,Old
Kashmir.
Brand Respityl-C Oral Powder
Composition Each 100gm contains: -
Doxycycline HCL … 40 gm
Tylosin Tartrate …20 gm
Colistin Sulphate …10 MIU
Bromhexine HCl …2 gm
Diary No. Date of R& I & fee Dy.No:31086 , dated:12-11-2021, Rs.30,000/-,
dated: 11-11-2021
Pharmacological Group Antibiotic, Mucolytic
Type of Form Form 5
Pack size & demanded price 100gm,500gm,1 Kg,5Kg,10Kg, 25Kg./ Decontrolled
Me-too status MULTIDOX ORAL POWDER
REG.# 078395
HAWK BIO PHARMA ISLAMABAD.
GMP status GMP inspection held on 14-10-2021
Panel Inspection
Panel recommended the approval of 4 additional
sections
Remarks of the Evaluator • Firm has applied Colistin Sulphate …10 MIU in
Form-5, whereas, me-too contains Colistin Sulphate
…10 gm.
firm.
Case no. 04 Registration applications of newly granted DML or New section (human)
a. New DML /section
415. Name, address of Applicant / Marketing M/s Alfalah Pharma Private Limited
Authorization Holder 12-Km Sheikhupura Road, Lahore.
Name, address of Manufacturing site. M/s Alfalah Pharma Private Limited

12-Km Sheikhupura Road, Lahore.
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 26801 , dated 28/09/2021
DU-LIFE 30 mg capsule
name
Pharmaceutical ingredient (API) per unit Duloxetine (as hydrochloride) …….30mg
(As enteric coated pellets) from M/s vision
Pharma
Pharmaceutical form of applied drug Red colour cap and body, oblong shaped
capsules containing white to off white colour
entric coated spherical pellets capsules.
Pharmacotherapeutic Group of (API) SSRI (Anti-depressant)
USP
specifications
The status in reference regulatory Cymbalta 30mg capsule by M/s Eli Lilly and
authorities Company, USFDA Approved.
For generic drugs (me-too status) Hapibar 30 mg Caspule by M/s Barrett
Hodgson Pakistan (Pvt) Ltd., Reg. No.
061745
GMP status of the Finished product New Section Approved on 13/02/2020
manufacturer Capsule (General) section approved.
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Ltd.
Plot 22-23, Industrial Triangle, Kahuta Road,
Islamabad, Pakistan
product.
Module III (Drug Substance) Firm has submitted detailed data for drug

batches of drug substance at both accelerated
as well as real time conditions. The
40°C ± 2°C / 75% ± 5% RH for 6 months.
30°C ± 2°C / 65% ± 5% RH for 36 months.
Pharmaceutical equivalence and Firm has submitted results of
comparative dissolution profile pharmaceutical equivalence /Comparative
dissolution for their product against the
reference product i.e. Dulan 30mg capsule
manufactured by M/s Hilton Pharma (Pvt)
Ltd. (Batch number 132101).
Analytical method validation/verification of Firm has submitted report of verification
product studies of analytical method for the drug
substance.
Firm has submitted report of verification
studies of analytical method for the drug
product.
Manufacturer of API M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial Triangle
Kahuta Road Islamabad.
API Lot No. DXT275
Description of Pack
Batch No. DL301 DL302 DL303
No. of Batches 03

a. Reference of previous approval of Firm has submitted that their capsule section
applications with stability study data of the is a new facility and was inspected by panel
firm (if any) of inspectors on 26-06-2019 and 16-09-2019
for grant of new section.
b. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate
API manufacturer issued by concerned dated 31-07-2019 issued by Additional
regulatory authority of country of origin. Director (QA&LT) DRAP Islamabad. The
c. Documents for the procurement of API with Firm has submitted copy of commercial
approval from DRAP (in case of import). invoice dated 21-02-2020 specifying
purchase of 1kg Duloxetine (as
hydrochloride) 17.0% EC pellets.
d. Data of stability batches will be supported by Firm has submitted complete record of
attested respective documents like testing of all batches along with raw data
chromatograms, Raw data sheets, COA, sheets, HPLC chromatograms COA and
e. Compliance Record of HPLC software N/A
testing
f. Record of Digital data logger for temperature Firm has submitted record of digital data
and humidity monitoring of stability logger for temperature and humidity
chambers (real time and accelerated) monitoring of real time and accelerated
stability chambers.
Decision: Approved.
• Registration letter will be issued upon submission of Pharmaceutical Equivalence & CDP
studies against the Innovator product i.e., Cymbalta.
New license granted on 21/09/2021by CLB
Cephalosporin section approved.
2 molecules / 10products
416. Name, address of Applicant / Marketing M/s Citi Pharma Private Limited Lahore
Name, address of Manufacturing site. M/s Citi Pharma Private Limited Lahore
Factory: 3 K.M, Head Balloki Road, Phool
Nagar, Distt. Kasur
☐ Importer
giver)
☐ Export sale

Dy. No. and date of submission Dy.No 5513 dated 28/02/2022
Citi-Axone Injection IM
name
Strength / concentration of drug of Active Sterile powder of Ceftriaxone sodium USP
Pharmaceutical ingredient (API) per unit eq. to Ceftriaxone 1g
Pharmaceutical form of applied drug Intra-Muscular Injection
Pharmacotherapeutic Group of (API) Broad-spectrum cephalosporin antibiotic
USP
specifications
The status in reference regulatory Rocephin Injection 1gm
authorities by M/s Rouche Laboratories Inc. UK,
USFDA Approved.
For generic drugs (me-too status) Oxidil Injection 1gm by Sami
Pharmaceuticals, Reg. No. 022422
manufacturer Cephalosporin section approved.
Ltd. China
submitted.
Module III (Drug Substance) Official monograph of Ceftriaxone Sodium
eq. to Ceftriaxone is present in USP. The firm
as submitted detail of nomenclature,
manufacturing process and controls, t,
of drug substance
months
6 months
Batches: (TRI-013, TRI-014, TRI-015)

specifications, analytical procedure
(including dissolution testing at acidic and
buffer medium) and its verification studies,
product.
Inocef 1gm Injection by Barrett Hodgson
Pakistan performing quality tests
(Identification, Assay, Constituted Solution,
Manufacturer of API M/s Qilu Antibiotics Pharmaceutical Co., Ltd. China
API Lot No. CC0121060125
Description of Pack One clear glass vial 15ml with Glass ampule type-I of 1%
(Container closure system) Lidocaine HCl 3.5 ml along with leaflet in unit carton.
Batch No. TRI-013 TRI-014 TRI-015
Batch Size (Scientifically 300 Vials 300 Vials 300 Vials
rational batch size)
No. of Batches 03
firm (if any)
26. Approval of API/ DML/GMP certificate of Copy of GMP certificate No. SD20170635
API manufacturer issued by concerned issued by CFDA valid till 13/12/2022.
27. Documents for the procurement of API with Letter No. 10676/2021 DRAP dated 15-07-
approval from DRAP (in case of import). 2021
B/L No. YML4S236121840 dated: 01-07-
2021

28. Data of stability batches will be supported Firm has submitted record of testing of
by attested respective documents like batches along with
chromatograms, chromatograms, raw data sheets, COA and
Raw data sheets, COA, summary data sheets summary data sheets
etc.
29. Compliance Record of HPLC software The firm has submitted compliance record
21CFR & audit trail reports on product of HPLC software 21
testing CFR and copies of audit trail on testing of
drug product.
temperature and humidity monitoring of for temperature and
stability chambers (real time and humidity monitoring of real time and
accelerated) accelerated stability
chambers.
Sr. no Short comings Response
a. 3.2.S.7 Stability studies are not as per Stability data has been submitted as per Zone
zone IVA IV
months
months
b. Some parts of applications states Intra Its typographic error and rectified, correct data
muscular (IM) injection whereas at have been submitted.
some it states Intra venous (IV).
c. 3.2.P.2 why not the pharmaceutical Pharmaceutical Equivalence have been
equivalence of the applied drug being established against the brand leader that is
compared with the innovator’s Inocef 1gm IM Injection by Barrett Hodgson
product Pakistan performing quality tests
d. 3.2.P.5 Justification is required for the Its typographic error, we didn’t avail the
use of 5% overage in master overage
formulation.
e. Documents for the procurement of M/S Qilu Antibiotic Pharmaceutical Co. Ltd,
API with approval from DRAP (in China
case of import). API Lot Number: CC0121060125
Letter No. 10676/2021DRAP Dated: 15-07-
2021.
B/L No. YML4S236121840 Dated: 01-07-2021
API import documents has been submitted with
ADC clearance
f. Compliance Record of HPLC Record of HPLC software 21 CFR and audit
software 21CFR &audit trail reports trail reports has been submitted in detailed.
on product testing.
g. Record of Digital data logger for Record of Digital data logger for temperature
temperature and humidity monitoring and humidity monitoring of stability chambers
of stability chambers (real time and (real time and accelerated) has been submitted
accelerated).
Decision: Approved.

• Registration letter will be issued upon submission of Pharmaceutical Equivalence studies
against the Innovator product i.e., Rocephin Injection.
417. Name, address of Applicant / M/s Citi Pharma Private Limited
Marketing Authorization Holder Lahore
Nagar, Distt. Kasur
☐ Importer
☐ Is involved in none of the above
(contract giver)
☐ Export sale
Citi-Axone Injection IV
name
Pharmaceutical ingredient (API) per unit eq. to Ceftriaxone 1g
Pharmaceutical form of applied drug Intra-venous Injection
USP
specifications
USFDA Approved.
Ltd. China
QOS-PD template. Summarized
physical form, manufacturers, description

Module III (Drug Substance) Official monograph of Ceftriaxone
Sodium eq. to Ceftriaxone is present in
USP. The firm as submitted detail of
its verification, batch analysis and
Real time: 30°C ± 2°C / 65% ± 5%RH for
6 months
for 6 months
(Identification, Assay, Constituted
Solution, Uniformity of dosage form).
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along
(Container closure system) with leaflet in unit carton.

Batch Size (Scientifically rational 300 Vials 300 Vials 300 Vials
batch size)
No. of Batches 03
firm (if any)
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate No.
API manufacturer issued by concerned SD20170635 issued by CFDA valid till
regulatory authority of country of origin. 13/12/2022.
3. Documents for the procurement of API Letter No. 10676/2021 DRAP dated 15-
with approval from DRAP (in case of 07-2021
import). B/L No. YML4S236121840 dated: 01-07-
2021
chromatograms, chromatograms, raw data sheets, COA
Raw data sheets, COA, summary data and summary data sheets
sheets etc.
5. Compliance Record of HPLC software The firm has submitted compliance
21CFR & audit trail reports on product record of HPLC software 21
testing CFR and copies of audit trail on testing
of drug product.
chambers.
zone IVA IV
months
months

compared with the innovator’s Inocef 1gm IV Injection by Barrett Hodgson
formulation.
2021.
B/L No. YML4S236121840 Dated: 01-07-2021
ADC clearance
on product testing.
accelerated).
Decision: Approved.
Nagar, Distt. Kasur
☐ Importer
giver)
☐ Export sale

name
Pharmaceutical ingredient (API) per unit eq. to Ceftriaxone 2gm
Pharmaceutical form of applied drug Intra-venous Injection
USP
specifications
USFDA Approved.
Ltd. China
substance
months
months
Batches: (T-CSI001, T-CSI002, T-CSI003)

product.
product including linearity, range, accuracy,
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along with
(Container closure system) leaflet in unit carton.
Batch No. T-CSI001 T-CSI002 T-CSI003
Batch Size (Scientifically 300 injections 300 injections 300 injections
No. of Batches 03
firm (if any)
B/L No. YML4S236121840 dated: 01-07-
2021

4. Data of stability batches will be supported by Firm has submitted record of testing of
attested respective documents like batches along with
etc.
drug product.
6. Record of Digital data logger for temperature Firm has submitted record of data logger
and humidity monitoring of stability for temperature and
chambers (real time and accelerated) humidity monitoring of real time and
accelerated stability
chambers.
zone IVA IV
months
months
compared with the innovator’s Inocef 2gm IV Injection by Barrett Hodgson
formulation.
2021.
B/L No. YML4S236121840 Dated: 01-07-2021
ADC clearance
on product testing.
accelerated).

Decision: Approved.
Nagar, Distt. Kasur
☐ Importer
giver)
☐ Export sale
Citi-Axone Injection 250 IM
name
Pharmaceutical ingredient (API) per unit eq. to Ceftriaxone 250mg
Pharmaceutical form of applied drug Intra-muscular Injection
USP
specifications
The status in reference regulatory Rocephin Injection 250mg
USFDA Approved.
For generic drugs (me-too status) Oxidil Injection 250mg by Sami
Ltd. China

substance
months
months
product.
Inocef 250mg Injection by Barrett Hodgson
product including linearity, range, accuracy,

atch Size (Scientifically rational 300 Vials 300 Vials 300 Vials
batch size)
No. of Batches 03
firm (if any)
B/L No. YML4S236121840 dated: 01-07-
2021
4. Data of stability batches will be supported by Firm has submitted record of testing of
attested respective documents like batches along with
etc.
drug product.
6. Record of Digital data logger for temperature Firm has submitted record of data logger
and humidity monitoring of stability for temperature and
chambers (real time and accelerated) humidity monitoring of real time and
accelerated stability
chambers.
zone IVA IV
months
months

compared with the innovator’s Inocef 250mg Injection by Barrett Hodgson
formulation.
2021.
B/L No. YML4S236121840 Dated: 01-07-2021
ADC clearance
on product testing.
accelerated).
Decision: Approved.
420. Name, address of Applicant / M/s Citi Pharma Private Limited Lahore
Name, address of Manufacturing M/s Citi Pharma Private Limited Lahore
site. Factory: 3 K.M, Head Balloki Road, Phool
Nagar, Distt. Kasur
☐ Importer
giver)
brand name

Strength / concentration of drug of Sterile powder of Ceftriaxone sodium USP
Active Pharmaceutical ingredient eq. to Ceftriaxone 250mg
(API) per unit
Intra-venous Injection
drug
Broad-spectrum cephalosporin antibiotic
(API)
USP
specifications
USFDA Approved.
Name and address of API M/s Qilu Antibiotics Pharmaceutical Co.,
manufacturer. Ltd. China
Summary) PD template. Summarized information
submitted.
of drug substance
months
months

product.
Inocef 250mg Injection by Barrett Hodgson
atch Size (Scientifically 300 Vials 300 Vials 300 Vials
No. of Batches 03
certificate of API manufacturer issued by CFDA valid till 13/12/2022.
9. Documents for the procurement of Letter No. 10676/2021 DRAP dated 15-07-
API with approval from DRAP (in 2021
case of import). B/L No. YML4S236121840 dated: 01-07-
2021

10. Data of stability batches will be Firm has submitted record of testing of
supported by attested respective batches along with
documents like chromatograms, chromatograms, raw data sheets, COA and
Raw data sheets, COA, summary summary data sheets
data sheets etc.
11. Compliance Record of HPLC The firm has submitted compliance record
software 21CFR & audit trail reports of HPLC software 21
on product testing CFR and copies of audit trail on testing of
drug product.
temperature and humidity for temperature and
monitoring of stability chambers humidity monitoring of real time and
(real time and accelerated) accelerated stability
chambers.
a. 3.2.S.7 Stability studies are not as Stability data has been submitted as per Zone
per zone IVA IV
months
months
b. Some parts of applications states Its typographic error and rectified, correct
Intra muscular (IM) injection data have been submitted.
whereas at some it states Intra
venous (IV).
equivalence of the applied drug established against the brand leader that is
being compared with the Inocef 250mg Injection by Barrett Hodgson
innovator’s product Pakistan performing quality tests
d. 3.2.P.5 Justification is required for Its typographic error, we didn’t avail the
the use of 5% overage in master overage
formulation.
2021.
B/L No. YML4S236121840 Dated: 01-07-
2021
API import documents has been submitted
with ADC clearance
on product testing.
temperature and humidity and humidity monitoring of stability

monitoring of stability chambers chambers (real time and accelerated) has
(real time and accelerated). been submitted
Decision: Approved.
site. Factory: 3 K.M, Head Balloki Road,
Phool Nagar, Distt. Kasur
☐ Importer
(contract giver)
Citi-Axone Injection IM
brand name
Strength / concentration of drug of Sterile powder of Ceftriaxone sodium
Active Pharmaceutical ingredient USP eq. to Ceftriaxone 500mg
(API) per unit
Intra-Muscular Injection
drug
(API)
USP
specifications
USFDA Approved.
Name and address of API M/s Qilu Antibiotics Pharmaceutical
manufacturer. Co., Ltd. China.

Module-II (Quality Overall Firm has submitted QOS as per WHO
Summary) QOS-PD template. Summarized
controls, impurities, specifications,
studies of drug substance and drug
6 months
for 6 months
comparative dissolution profile established against the brand leader that
is Inocef 500mg Injection by Barrett
Hodgson Pakistan performing quality
tests (Identification, Assay, Constituted
Analytical method Method verification studies have
validation/verification of product submitted including linearity, range,

Description of Pack One clear glass vial 15ml with Glass ampule type-I of 1%
(Container closure system) Lidocaine HCl 2.0 ml along with leaflet in unit carton.
No. of Batches 03
2. Approval of API/ DML/GMP Copy of GMP certificate No.
certificate of API manufacturer SD20170635 issued by CFDA valid till
issued by concerned regulatory 13/12/2022.
3. Documents for the procurement of Letter No. 10676/2021 DRAP dated 15-
API with approval from DRAP (in 07-2021
case of import). B/L No. YML4S236121840 dated: 01-
07-2021
documents like chromatograms, chromatograms, raw data sheets, COA
Raw data sheets, COA, summary and summary data sheets
data sheets etc.
5. Compliance Record of HPLC The firm has submitted compliance
software 21CFR & audit trail reports record of HPLC software 21
on product testing CFR and copies of audit trail on testing
of drug product.
6. Record of Digital data logger for Firm has submitted record of data
temperature and humidity logger for temperature and
chambers.
a. 3.2.S.7 Stability studies are not as Stability data has been submitted as per
per zone IVA Zone IV
months

6 months
venous (IV).
c. 3.2.P.2 why not the Pharmaceutical Equivalence have been
pharmaceutical equivalence of the established against the brand leader that is
applied drug being compared with Inocef 500mg Injection by Barrett Hodgson
the innovator’s product Pakistan performing quality tests
formulation.
e. Documents for the procurement of M/S Qilu Antibiotic Pharmaceutical Co.

API with approval from DRAP (in Ltd, China
2021.
B/L No. YML4S236121840 Dated: 01-07-
2021
with ADC clearance
software 21CFR &audit trail trail reports has been submitted in detailed.
g.Record of Digital data logger for Record of Digital data logger for
temperature and humidity temperature and humidity monitoring of
monitoring of stability chambers stability chambers (real time and
(real time and accelerated). accelerated) has been submitted
Decision: Approved.
• Registration letter will be issued upon submission of Pharmaceutical Equivalence
studies against the Innovator product i.e., Rocephin Injection.

☐ Importer
(contract giver)

brand name
Strength / concentration of drug of Sterile powder of Ceftriaxone sodium
Active Pharmaceutical ingredient USP eq. to Ceftriaxone 500mg
(API) per unit
Intra-venous Injection
drug
(API)
USP
specifications
USFDA Approved.
Name and address of API M/s Qilu Antibiotics Pharmaceutical
manufacturer. Co., Ltd. China

6 months
for 6 months
is Inocef 500mg Injection by Barrett
Hodgson Pakistan performing quality
tests (Identification, Assay, Constituted
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI along
(Container closure system) with leaflet in unit carton.
No. of Batches 03

certificate of API manufacturer SD20170635 issued by CFDA valid till
9. Documents for the procurement of Letter No. 10676/2021 DRAP dated 15-
case of import). B/L No. YML4S236121840 dated: 01-
07-2021
data sheets etc.
of drug product.
chambers.
months
6 months
venous (IV).
applied drug being compared with Inocef 500mg Injection by Barrett Hodgson
the innovator’s product Pakistan performing quality tests
formulation.
e. Documents for the procurement of M/S Qilu Antibiotic Pharmaceutical Co.

API with approval from DRAP (in Ltd, China

2021.
B/L No. YML4S236121840 Dated: 01-07-
2021
with ADC clearance
g. Record of Digital data logger for Record of Digital data logger for
Decision: Approved.
studies against the Innovator product i.e., Rocephin Injection.

☐ Importer
(contract giver)
Citi-Taxime Injection IV
brand name
Strength / concentration of drug of Sterile Powder of Cefotaxime sodium
Active Pharmaceutical ingredient USP eq. to Cefotaxime 1gm
(API) per unit
Intra-venous
drug
(API)

USP
specifications
The status in reference regulatory Cefotaxime powder for solution Injection
authorities 1gm
by M/s Wockhardt Ltd. UK,
USFDA Approved.
For generic drugs (me-too status) Sporonil Injection 1gm by Global
Name and address of API M/s Sinopharm Weiqida Pharmaceutical
manufacturer. Co.,Ltd China
Module III (Drug Substance) Official monograph of Cefotaxime
Sodium eq. to Cefotaxime is present in
6 months
for 6 months

is Sporonil Injection 1g by Global
Pharmaceuticals Pakistan performing
quality tests (Identification, Assay,
Constituted Solution, Uniformity of
dosage form).
Manufacturer of API M/s Sinopharm Weiqida Pharmaceutical Co.,Ltd China
Description of Pack One clear glass vial 15ml with LDPE ampoule of WFI or 1%
(Container closure system) Lidocaine along with leaflet in unit carton.
No. of Batches 03
certificate of API manufacturer SX20180255 issued by CFDA valid till
3. Documents for the procurement of Letter No. 8084/2021 DRAP dated: 04-
case of import). B/L No. 229111000081 dated: 23-06-
2021

data sheets etc.

of drug product.
chambers.
months
6 months
venous (IV).
applied drug being compared with Sporonil 1gm IV Injection by Global
the innovator’s product Pharmaceutical, Islamabad performing
Constituted Solution, Uniformity of dosage
form).
formulation.
e. Documents for the procurement of • M/S Sinipharm Weiqida

API with approval from DRAP (in Pharmaceutical Co. Ltd. China
case of import). API Lot Number: FB-2021/03/13
Letter No. 8084/2021 DRAP Dated: 04-08-
2021.
B/L No. 229111000081 Dated: 23-06-2021
with ADC clearance
g. Record of Digital data logger for Record of Digital data logger for
Decision: Approved.

studies against the Innovator product.

☐ Importer
(contract giver)
Citi-Taxime Injection IV/IM
brand name
Active Pharmaceutical ingredient USP eq. to Cefotaxime 250mg
(API) per unit
Intra-venous / Intra-muscular Injection
drug
(API)
USP
specifications
The status in reference regulatory Claforan Injection 250mg
authorities by M/s Sanofi aventis Ltd. USA,
USFDA Approved.
For generic drugs (me-too status) Sporonil Injection 250mg by Global

6 months
for 6 months
is Sporonil Injection 250mg by Global
Constituted Solution, Uniformity of
dosage form).

No. of Batches 03
2021

data sheets etc.
software 21CFR & audit trail reportsrecord of HPLC software 21
of drug product.
chambers.
h. 3.2.S.7 Stability studies are not as Stability data has been submitted as per

months
6 months
i. Some parts of applications states Its typographic error and rectified, correct
venous (IV).
j. 3.2.P.2 why not the Pharmaceutical Equivalence have been
applied drug being compared with Sporonil Injection by Global
form).
k. 3.2.P.5 Justification is required for Its typographic error, we didn’t avail the
formulation.
l.Documents for the procurement of • M/S Sinopharm Weiqida

2021.
B/L No. 229111000081 Dated: 23-06-2021
with ADC clearance
m. Compliance Record of HPLC Record of HPLC software 21 CFR and audit
n. Record of Digital data logger for Record of Digital data logger for
Decision: Approved.
☐ Importer

(contract giver)
Citi-Taxime Injection IV/IM
brand name
Active Pharmaceutical ingredient USP eq. to Cefotaxime 500mg
(API) per unit
Intra-venous / Intra-muscular Injection
drug
(API)
USP
specifications
The status in reference regulatory Claforan Injection 500mg
authorities by M/s Sanofi aventis Ltd. USA,
USFDA Approved.
For generic drugs (me-too status) Sporonil Injection 500mg by Global

6 months
for 6 months
is Sporonil Injection 500mg by Global
Dissolution, Uniformity of dosage form).

No. of Batches 03
2021
data sheets etc.
of drug product.
chambers.
o. 3.2.S.7 Stability studies are not as Stability data has been submitted as per
months
6 months
p. Some parts of applications states Its typographic error and rectified, correct
venous (IV).
q. 3.2.P.2 why not the Pharmaceutical Equivalence have been
applied drug being compared with Sporonil Injection by Global
form).

r. 3.2.P.5 Justification is required for Its typographic error, we didn’t avail the
formulation.
s. Documents for the procurement of • M/S Sinipharm Weiqida

2021.
B/L No. 229111000081 Dated: 23-06-2021
with ADC clearance
t. Compliance Record of HPLC Record of HPLC software 21 CFR and audit
u. Record of Digital data logger for Record of Digital data logger for
Decision: Approved.
Case no. 08 Registration applications for local manufacturing of (Human) drugs (Form
5F)
a. New cases
426. Name, address of Applicant / M/s Martin Dow Limited, Plot no. 37,
Marketing Authorization Holder Sector 19, Korangi Industrial Area,
Karachi
Name, address of Manufacturing site. M/s Indus Pharma (Pvt) Ltd.
Plot No. 26-27, 64-67, Sector-27, Korangi
Industrial Area, Karachi, Pakistan
☐ Importer
giver)
☐ Export sale

Fuvelox Infusion 500mg/100ml
name
Strength / concentration of drug of Each Vial of 100ml contains:
Active Pharmaceutical ingredient Levofloxacin hemihydrate eq to Levofloxacin
(API) per unit …………… 500mg
Pharmaceutical form of applied drug Infusion
Pharmacotherapeutic Group of (API) Fluroquinolone antibiotic
Reference to Finished product Firm has applied USP, however not available
specifications in USP pharmacopoeia.
“LEVAQUIN” USFDA Approved
authorities
For generic drugs (me-too status) Starlev Infusion 500mg by M/s Indus Pharma
(Registration No. 044460)
GMP status of the Finished product GMP certificate issued on 18-12-2020
manufacturer
Name and address of API manufacturer. M/s Shangyu Jingxin Pharmaceutical Co.,
Ltd.
Address:
No. 31 Weisan Road, Hangzhou Bay
Shangyu Economic and Technological
Development Area.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per WHO
QOS PD template.
impurity & related substances, specifications,
analytical procedures and its verification, batch
months
months
Batches: (DK211508311, DK211508312 &
DK211508313)
Module-III (Drug Product): The firm has submitted detail of manufacturer,
procedure and its validation studies, batch
Pharmaceutical equivalence and Pharmaceutical equivalence of Fuvelox
comparative dissolution profile Infusion has been compared with the

comparator product Leflox Infusion
500mg/100ml by M/s Getz Pharma by
performing quality tests.
specificity.
Manufacturer of API M/s Shangyu Jingxin Pharmaceutical Co., Ltd.
Address:
No. 31 Weisan Road, Hangzhou Bay Shangyu Economic
and Technological Development Area.
API Lot No. DK211807031-II
Description of Pack
A round clear glass vial having 100ml filling capacity.
Batch No. SL-384 SL-385 SL-386
No. of Batches 03
1. Reference of previous approval of Firm has referred to their product Canazin
applications with stability study data of Tablets 300mg which was approved in 289th
the firm (if any) Meeting of Registration Board.
1) Yes HPLC software is 21 CFR Part 11
compliant where all user levels are
properly defined
2) Audit trail on the testing reports is
available.
2. Approval of API/ DML/GMP certificate Copy of GMP Certificate for M/s Shangyu
of API manufacturer issued by Jingxin Pharmaceutical Co., Ltd issued by
concerned regulatory authority of National Medical Products Administration
country of origin. China & valid up to 29-11-2024 is submitted
3. Documents for the procurement of API Firm has submitted (invoice#
with approval from DRAP (in case of JXHQ1807203) dated 20-07-2018
import). specifying import LEVOFLOXACIN
cleared by DRAP Karachi office dated 15-
08-2018.
4. Data of stability batches will be Firm has submitted record of testing of batches
supported by attested respective along with chromatograms, raw data sheets,
documents like chromatograms, Raw COA and summary data sheets
etc.

5. Compliance Record of HPLC software The firm has submitted compliance record of
21CFR & audit trail reports on product HPLC software 21 CFR and copies of audit
testing trail on testing of drug product.
accelerated)
Evaluation by PEC:
Observations / Deficiency / Shortcomings Firm Response
3.2.S.4.4 Compare the COA’s of API from Firm has provided comparison of COAs
finish product manufacturer with COA of API Residual solvents and microbial limit tests
supplier and justification is required for non- were not performed by M/s Indus Pharma
performance of test, if any. as this does not exist in USP monograph.
Batch Calculation for Levofloxacin:
In Levofloxacin infusion, there is no
overage used instead potency adjustment is
carried out to adjust the water content of
API.
As per USP, Levofloxacin hemihydrate
contains 2.0 to 3.0% water. This water
3.2.P.5 Justification is required for the use of content is adjusted using below mentioned
overage in master formulation. calculation:
Standard quantity of API for batch = ---------
----
Potency (as is basis) = --------------------------
----
Required quantity for batch = (Standard
quantity of API x 100)/ Potency (as is basis)
Required quantity for batch = -----------------
Copy of GMP Certificate for M/s Shangyu
Valid GMP certificate of API manufacturer is Jingxin Pharmaceutical Co., Ltd issued by
required. National Medical Products Administration
China & valid up to 29-11-2024 is submitted
Decision: Approved.
• Firm shall submit the fee of Rs. 7,500 for revision of specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
• Registration letter will be issued after review of pharmacopoeia of reference regulatory
authorities for availability of the product monograph.
427. Name, address of Applicant / M/s Martin Dow Limited, Plot no. 37,
Marketing Authorization Holder Sector 19, Korangi Industrial Area,
Karachi
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot no. 37,
Sector 19, Korangi Industrial Area, Karachi
☐ Importer
giver)

☐ Export sale
Solidow Tablets 5mg
name
Strength / concentration of drug of Each Film Coated Tablet contains:
Active Pharmaceutical ingredient Solifenacin Succinate …………5mg
(API) per unit
Pharmacotherapeutic Group of (API) Anti-muscarinic
As per innovator’s specifications
specifications
The status in reference regulatory USFDA Approved “VESICARE
authorities TABLET” by
Astellas Pharma US, Inc.
For generic drugs (me-too status) Solifen Tablets 5mg by Getz Pharma
(Registration No. 061202)
GMP status of the Finished product GMP certificate issued 11-6-2020
manufacturer
Name and address of API M/s Zhejiang Guobang Pharmaceuticals
manufacturer. Co., Ltd.
Address:
No. 6, Weiwu Road, Hangzhou Gulf
Shangyu Economic and Technological
Development Zone, Zhejiang, PR China.
Module-II (Quality Overall Summary) Firm has submitted QOS details as per
WHO
QOS PD template.
impurity & related substances, specifications,
substance
months

months
Batches: (170501, 170502 & 170503)
manufacturer, description of manufacturing
buffer medium) and its validation studies,
product.
comparative dissolution profile established against the Innovator product that
is VESICARE TABLETS 5mg by Astellas
Pharma Istanbul by performing quality tests
(Identification, Disintegration, Assay,
brand that is VESICARE TABLETS 5mg by
Astellas Pharma Istanbul, in Acid media (pH
1.2), Acetate buffer (pH 4.5) & Phosphate
Manufacturer of API M/s Zhejiang Guobang Pharmaceuticals Co., Ltd.
Address:
No. 6, Weiwu Road, Hangzhou Gulf Shangyu Economic
and Technological Development Zone, Zhejiang, PR
China.
API Lot No. 2011000080 (Manufacturer’s batch no. 200501)
Description of Pack
Alu-Alu blister packed in unit carton (2x5’s)
Real Time: 0, 3, 6, 9, 12, 24 (Months)
Batch No. NPD-T-1488-
NPD-T-1503-S NPD-T-1504-S
S
No. of Batches 03

1. Reference of previous approval of Firm has referred to their product Empator
applications with stability study data of Tablets 10mg which was approved in 291st
the firm (if any) Meeting of Registration Board held on 2nd -
4th September 2019.
According to the report following points
were confirmed.
• The firm has 21 CFR compliant
HPLC software
• The firm has audit trail reports
available.
• The firm possesses stability
chambers with digital data loggers.
2. Approval of API/ DML/GMP Copy of DML Certificate for Zhejiang
certificate of API manufacturer issued Guobang Pharmaceuticals Co., Ltd. issued by
by concerned regulatory authority of Zhejiang Food and Drug Administration &
country of origin. valid up to 08-12-2024 is submitted
with approval from DRAP (in case of (invoice# GBPH2020-2023) Dated: 02-11-
import). 2020 from Zhejiang Guobang
Pharmaceuticals Co., Ltd. cleared by
DRAP Karachi office dated 03-11-2020.
documents like chromatograms, Raw chromatograms, raw data sheets, COA and
data sheets, COA, summary data sheets summary data sheets
etc.
drug product.
temperature and humidity monitoring of temperature and humidity monitoring of
Evaluation by PEC:
Shortcomings communicated Response by firm

3.2.P.8 Stability: You have provided stability Firm has submitted stability Data till 6 months
data of 3 months only. on 22-12-2021.
The potency is adjusted as per 100% since the
results of assay are higher than 100 i.e., 100.4%
due to analytical variation. Batch proceeded
Adjust the potency of Solifenacin succinate accordingly because adjusting the potency for
in BMR according to the assay report. higher than 100% will result in decreasing the
amount of API per tablet. The statement is
supported by satisfactory QC results of stability
batches.

428. Name, address of Applicant / M/s Martin Dow Marker Limited,7-Jail
Marketing Authorization Holder Road, Quetta
Name, address of Manufacturing site. M/s Martin Dow Marker Limited,7-Jail
Road, Quetta
☐ Importer
giver)
☐ Export sale
Angiolo-D Tablet 50mg+12.5mg
name
Active Pharmaceutical ingredient Losartan Potassium, ……50mg
(API) per unit Hydrochlorothiazide…..12.5mg
Pharmaceutical form of applied drug Dark yellow color, flat round shaped film
coated tablets.
Pharmacotherapeutic Group of (API) Angiotensin II receptor antagonist &
Diuretics (Anti-hypertensive)
USP
specifications
Proposed Pack size As Per DPC
The status in reference regulatory HYZAAR® 50mg+12.5mg Tablets by M/s
authorities Merck Sharp & Dohme, USFDA Approved.
For generic drugs (me-too status) Co-Eziday Tablet 50mg+12.5mg by Werrick
Pharmaceutical Pakistan (Pvt.) Ltd., Reg.
No. 027042
GMP status of the Finished product Certificate No:015/2021-DRAP (Q)/K
th
manufacturer issued on 10 September 2021
Tablet (General & Psychotropic), Capsule
(General), Oral Liquid Syrup (General),
Sterile Liquid Injection/Ampoule,
Ointment/Cream, Dry Powder Sachet
(General), Dry Powder Suspension (General)
section approved.
Name and address of API Losartan Potassium:
manufacturer. M/s Zhejiang Huahai Pharmaceutical Co.,
Ltd. Chuannan, Duqiao, Linhai, Zhejiang,
317016, China.

Hydrochlorothiazide:
M/s Changzhou Pharmaceutical China
submitted.
Module III (Drug Substance) Official monograph of Losartan Potassium is
present in USP. The firm has submitted detail
related substances, specifications, analytical
months
6 months
Batches:
Real Time: T-01, T-02 & T-03
Accelerated Time: T-01, T-02 & T-03
product.
Hyzaar Tablets by Merck Sharp & Dohme
Limited by performing quality tests
(Identification, Assay, Dissolution).
brand in Acid media (pH 1.2), Acetate Buffer
(pH 4.5) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable
range.

Manufacturer of API Losartan Potassium:
M/s Zhejiang Huahai Pharmaceutical Co., Ltd.
Chuannan, Duqiao, Linhai, Zhejiang, 317016, China.
API Lot No. Losartan Potassium: HH20201310
Hydrochlorothiazide: CY119019
Description of Pack
Blister in Alu-Alu Foil
Tablets
Manufacturing Date 02- 02-2021 02-2021
2021
Date of Initiation 02-
02-2021 02-2021
2021
No. of Batches 03
1. Reference of previous approval of Acidex 60mg Capsule
applications with stability study data of Dexlansoprazole was approved in 312th
the firm (if any) Registration Board meeting.
1) Compliance Record of HPLC

on product testing were present
2. Approval of API/ DML/GMP Copy of GMP certificate No. 201907047

certificate of API manufacturer issued issued by CFDA valid till 15/01/2023.
by concerned regulatory authority of Copy of GMP certificate No. JS20180848
country of origin. issued by CFDA valid till 09/07/2023.
3. Documents for the procurement of API Losartan Potassium: ADC Invoice No:
with approval from DRAP (in case of HH20201310, 29-June-2020 is submitted
import). wherein the permission to import APIs
(Losartan Potassium) for the purpose of
Hydrochlorothiazide: ADC Invoice No:
CY119019, 04-Feb-2019 is submitted
wherein the permission to import APIs
(Hydrochlorothiazide) for the purpose of

etc.
drug product.
temperature and humidity monitoring of temperature and
chambers.
Remarks OF Evaluator IV:
3.2.S.4.4 Compare the COA’s of API from finish product Firm has provided comparison of COAs and
manufacturer with COA of API supplier and justification justified that the manufacturer has performed
is required for non-performance of test, if any. all the tests mentioned in Pharmacopeia.
Furthermore, COA reflects that pharmacopeial method
was not adopted in testing drug substance, please justify.
3.2.P.5.3 Control of Drug Substance: Analytical Method Firm has provided Analytical Method
Verification studies including specificity, accuracy and Verification studies including specificity,
repeatability (method precision) performed by the Drug accuracy and repeatability (method
Product manufacturer for both compendial as well as non- precision).
compendial drug substance(s) shall be submitted
3.2.P.4.5 Excipients of human & animal origin shall be Firm has submitted that there is no human
addressed for the use of “Magnesium Stearate” in the or animal source used for Magnesium
applied formulation. Stearate.
Valid GMP certificate of API manufacturer is required. Losartan Potassium: Firm has provided
GMP certificate No. 201907047 issued by
CFDA valid till 15/01/2023.
Hydrochlorothiazide: Firm has provided
GMP certificate No. JS20180848 issued by
Decision: Approved.
Road, Quetta
☐ Importer
(contract giver)

☐ Export sale
Angiolo-D Tablet 100mg+12.5mg
name
Active Pharmaceutical ingredient (API) Losartan Potassium, ……100mg
per unit Hydrochlorothiazide…..12.5mg
Pharmaceutical form of applied drug White to off white, biconvex, oblong film
coated, plain on one side engraved with
1.25 on other side.
USP
specifications
The status in reference regulatory HYZAAR® 100mg+12.5mg Tablets by
authorities M/s Merck Sharp & Dohme, USFDA
Approved.
For generic drugs (me-too status) Acozar-H Tablet 100mg+12.5mg by AGP
Ltd., Reg. No. 085660
manufacturer issued on 10th September 2021
(General), Dry Powder Suspension
(General) section approved.
Name and address of API manufacturer. Losartan Potassium:
M/s Zhejiang Huahai Pharmaceutical Co.,
317016, China.

Module III (Drug Substance) Official monograph of Losartan Potassium
is present in USP. The firm has submitted
60 months
for 6 months
Batches:
Real Time: T-01, T-02 & T-03
Hyzaar Tablets by Merck Sharp &
Dohme Limited by performing quality
tests (Identification, Assay, Dissolution).
brand that is in Acid media (pH 1.2),
Acetate Buffer (pH 4.5) & Phosphate
Buffer (pH 6.8). The values for f1 and f2
are in the acceptable range.

Description of Pack
Tablets
No. of Batches 03

reports on product testing were
present
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 201907047
of API manufacturer issued by concerned issued by CFDA valid till 15/01/2023.
regulatory authority of country of origin. Copy of GMP certificate No. JS20180848
issued by CFDA valid till 09/07/2023.
test/analysis and stability studies is
granted.
test/analysis and stability studies is
granted.
etc.
drug product.

chambers.
Remarks OF Evaluator VI:
manufacturer with COA of API supplier and justification justified that the manufacturer has
is required for non-performance of test, if any. performed all the tests mentioned in
Furthermore, COA reflects that pharmacopeial method Pharmacopeia.
3.2.P.4.5 Excipients of human & animal origin shall be Firm has confirmed that there is no human
Decision: Approved.
Road, Quetta
☐ Importer
giver)
☐ Export sale
Angiolo-D Tablet 100mg+25mg
name

Active Pharmaceutical ingredient Losartan Potassium……100mg
(API) per unit Hydrochlorothiazide…..25mg
Pharmaceutical form of applied drug Light yellow color, oblong biconvex shaped
film coated tablets.
USP
specifications
The status in reference regulatory HYZAAR® 100mg+25mg Tablets by M/s
authorities Merck Sharp & Dohme, USFDA Approved.
For generic drugs (me-too status) Co-Eziday Tablet 100mg+25mg by Werrick
Pharmaceutical Pakistan (Pvt.) Ltd., Reg.
No. 056104
section approved.
Name and address of API Losartan Potassium:
manufacturer. M/s Zhejiang Huahai Pharmaceutical Co.,
317016, China.
submitted.

months
6 months
Batches:
Real Time: T-01, T-02 & T-03
product.
Hyzaar Tablets by Merck Sharp & Dohme
brand in Acid media (pH 1.2), Acetate Buffer
(pH 4.5) & Phosphate Buffer (pH 6.8). The
values for f1 and f2 are in the acceptable
range.
Description of Pack

Tablets
2021
07-2021 07-2021
2021
No. of Batches 03

testing were present
by concerned regulatory authority of Copy of GMP certificate No. JS20180848
country of origin. issued by CFDA valid till 09/07/2023.
etc.
drug product.
chambers.

3.2.P.4.5 Excipients of human & animal origin shall be Firm has confirmed that there is no human
Decision: Approved.
431. Name, address of Applicant / M/s Martin Dow Marker Limited, 7-Jail
Name, address of Manufacturing site. M/s Martin Dow Marker Limited, 7-Jail
Road, Quetta
☐ Importer
giver)
☐ Export sale
Angiolo Tablet 50mg
name
(API) per unit
Pharmaceutical form of applied drug Peach, round shaped film coated Tablets
Pharmacotherapeutic Group of (API) Angiotensin II receptor antagonist
(Anti-hypertensive)
USP
specifications
Proposed Pack size 2×10’s (20’s)

The status in reference regulatory AURO-LOSARTAN Tablet 50mg by M/s
authorities Auro Pharma Inc. HEALTH CANADA
Approved.
For generic drugs (me-too status) Bespar Tablet 50mg by Nabiqasim Industries
(Pvt.) Ltd. , Reg. No. 027206
section approved.
Name and address of API M/s Zhejiang Huahai Pharmaceutical Co.,
manufacturer. Ltd. Chuannan, Duqiao, Linhai, Zhejiang,
317016, China
submitted.
months
6 months
Batches:
Real Time: C5082-14-136, C5082-14-137,
C5082-14-138
Accelerated Time: C5455-13-135, C5455-
13-136, C5455-13-137

product.
Cozaar Tablets by Merck Sharp & Dohme
brand that is Cozaar Tablets by Merck
Sharp & Dohme Limited in Acid media
(pH 1.2), Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1
Manufacturer of API M/s Zhejiang Huahai Pharmaceutical Co., Ltd., Chuannan,
Duqiao, Linhai, Zhejiang 317016, China
API Lot No. C5455-20-045
Description of Pack
Tablets
No. of Batches 03


country of origin.
3. Documents for the procurement of API ADC Invoice No: HH20201310, 11-June-
with approval from DRAP (in case of 2020 is submitted wherein the permission
import). to import APIs (Losartan Potassium) for
the purpose of test/analysis and stability
studies is granted.

Raw data sheets, COA, summary data summary data sheets
sheets etc.
drug product.
chambers.
Valid GMP certificate of API manufacturer is required. Firm has provided GMP certificate No.
201907047 issued by CFDA valid till
15/01/2023.
Decision: Approved.
432. Name, address of Applicant / M/s Martin Dow Marker Ltd. ,7-Jail
Name, address of Manufacturing site. M/s Martin Dow Marker Ltd. ,7-Jail Road,
Quetta
☐ Importer

giver)
☐ Export sale
Angiolo Tablet 25mg
name
(API) per unit
Pharmaceutical form of applied drug Round, white to off-white tablets.
Pharmacotherapeutic Group of (API) Angiotensin II receptor antagonist
(Anti-hypertensive)
USP
specifications
Proposed Pack size 2×10’s (20’s)
The status in reference regulatory Cozaar 25mg tablet by M/s Organon Canada
authorities Inc, HEALTH CANADA Approved.
For generic drugs (me-too status) Sozaar 25mg Tablet by Alliance
Pharmaceuticals (Pvt.) Ltd. , Reg. No.
044580
th
manufacturer issued on 10 September 2021
section approved.
Name and address of API M/s Zhejiang Huahai Pharmaceutical Co.,
manufacturer. Ltd. Chuannan, Duqiao, Linhai, Zhejiang,
317016, China

submitted.
months
6 months
Batches:
Real Time: C5082-14-136, C5082-14-137,
C5082-14-138
Accelerated Time: C5455-13-135, C5455-
13-136, C5455-13-137
product.
Cozaar Tablets by Merck Sharp & Dohme
brand that is Cozaar Tablets by Merck
Sharp & Dohme Limited in Acid media
(pH 1.2), Acetate Buffer (pH 4.5) &
Phosphate Buffer (pH 6.8). The values for f1

Manufacturer of API M/s Zhejiang Huahai Pharmaceutical Co., Ltd., Chuannan,
Duqiao, Linhai, Zhejiang 317016, China

API Lot No. C5455-20-045
Description of Pack
Tablets
No. of Batches 03

country of origin.
3. Documents for the procurement of API ADC Invoice No: HH20201310, 11-June-
with approval from DRAP (in case of 2020 is submitted wherein the permission
import). to import API (Losartan Potassium) for
the purpose of test/analysis and stability
studies is granted.

etc.
drug product.
chambers.

Valid GMP certificate of API manufacturer is required. Firm has provided GMP certificate No.
201907047 issued by CFDA valid till
15/01/2023.
Decision: Approved.
433. Name, address of Applicant / M/s ATCO Laboratories Limited
Marketing Authorization Holder Address: B-18,S.I.T.E., Karachi -
75700,Karachi.Sindh
Name, address of Manufacturing site. ATCO Laboratories Limited
Address: B-18,S.I.T.E., Karachi -
75700,Karachi.Sindh
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 25929 Dated 17/ 09/ 2021
Tapentadol Tablets 75mg
name
Active Pharmaceutical ingredient Tapentadol Hydrochloride eq to
(API) per unit Tapentadol ……..75mg
Pharmaceutical form of applied drug Film coated Tablet
Pharmacotherapeutic Group of (API) Opioid analgesic of the benzenoid class.
As per Innovator’s specifications
specifications
Proposed Pack size 7s, 10s, 14s, 20s, 28s, 30s, 60s & 100s.

The status in reference regulatory NUCYNTA
authorities Manufactured by:
Janssen Ortho, LLC Gurabo, PR 00778
Manufactured for:
PriCara® Division of Ortho-McNeil-
Janssen
Pharmaceuticals, Inc. Raritan, NJ 08869
For generic drugs (me-too status) Tapento 75mg tablet
SAMI Pharmaceuticals (Pvt) Ltd.
GMP status of the Finished product Renewal for DML dated 27-03-
manufacturer 2021submitted along with previous copy
DML.
Name and address of API M/s Ami Lifesciences Private Limited,
manufacturer. 2 Floor, Prestige Plaza, 40, Urmi Society,
Nr. Urmi Cross Road, BPC Road, Akota,
Vadodara-390 020.Gujarat, INDIA.
Module III (Drug Substance) The firm has submitted detail of
Real time:30°C±2°C/65% ± 5%RH for 12
months
Accelerated:40°C±2°C/75%±5%RH for 6
months
Batches: (TPT/50121119, TPT/50131119,
TPT/5011119)

NUCYNTA 75mg Tablet by M/s Janssen
Ortho, LLC Gurabo, PR 00778
performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage
form).
brand that is NUCYNTA 75mg Tablet by
Janssen Ortho, LLC Gurabo, PR 00778 in
Acid media (pH 1.0-1.2) & Phosphate
precision, specificty.
Manufacturer of API Ami Lifesciences Private Limited INDIA
API Lot No. TPR/RD/60250618
Description of Pack The material packed in double polyethylene bags inner
(Container closure system) white transparent and outer black
Real Time: 0,3,6, 9,12 (Months)
Batch No. 50111119 50121119 50131219
Batch Size 310kg 313kg 313kg
No. of Batches 03
1. Reference of previous approval of Rofl 500mg tablet Approved in DRB 277
applications with stability study data of held on 27-29 December 2017.
the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP issued by (Drug Control
certificate of API manufacturer issued Administration, Government of Gujarat
by concerned regulatory authority of State India
country of origin. Validity: 25/04/2019 till 24/04/2022
3. Documents for the procurement of API Submitted
import).

documents like chromatograms, Raw chromatograms, raw data sheets, COA
data sheets, COA, summary data sheets and summary data sheets
etc.
drug product.
chambers.
• 3.2.S.4 Control of Drug Substance: - You have We already have submitted Raw Material
submitted finished product specifications, COA, specification and testing method of
analytical method etc. instead of providing drug Tapentadol Hydrochloride with Certificate
substance information. of Analysis (CoA) by both, drug substance
manufacturer and drug product
manufacturer, now as per your requirement
we are hereby re submitting the drug
substance information
• 3.2.S.7 Stability study data is not as per zone IV Stability data of Tapentadol Hydrochloride
A. drug substance by Ami Life Sciences, India
• as per zone IV-A has been provided already
we are hereby resubmitting the stability
study data as zone IV-A.
• 3.2.S.4 Control of Drug Substance:- A discussion The Drug Substance/API “Tapentadol
and justification should be provided for any Hydrochloride” has been analyzed by Drug
incomplete analyses of the drug substance / API Product manufacturer according to the
by Drug Product manufacturer (e.g. results not proposed specification and testing method
tested according to the proposed specification submitted in Section 3.2.S.4.
•
• 3.2.P.5 Control of Drug Product, 3.2.P.8 According to FDA Dissolution methods
Stability: - The submitted dissolution condition is database, updated on 07/02/2020 for
different from the innovators’. Tapentadol Hydrochloride Immediate
Dissolution conditions of innovator as per release Tablets, Refer to FDA’s Dissolution
Biopharmaceutics Review: Guidance, 2018. Also, Tapentadol
Apparatus: Type I (Basket apparatus) Hydrochloride belongs to Class I of
Spindle rotation: 75 RPM Biopharmaceutics Classification System, so
Medium: 0.1 M HCl the Standard Dissolution Testing Condition
Medium volume: 900ml has been employed for dissolution testing of
Time: 45 min drug product Tapentadol Hydrochloride and
Acceptance criteria: NLT 80% (Q) of the labelled amount validated through Comparative dissolution
of Tapentadol (as HCl) dissolved in 45 min profile studies as per “GUIDANCE
DOCUMENT FOR SUBMISSION OF
APPLICATION ON FORM 5-F (CTD) FOR
REGISTRATION OF
PHARMACEUTICAL DRUG PRODUCTS
FOR HUMAN USE” Drug Regulatory
Authority of Pakistan. Dissolution Method

from FDA website with FDA’s Dissolution
Guidance “Dissolution Testing and
Acceptance Criteria for Immediate-Release
Solid Oral Dosage Form Drug Products
Containing High Solubility Drug Substances
– Guidance for Industry” is being attached
for your reference. (Section 3.2.P.5)
• Manufacturer will revise dissolution specifications as per USFDA along with submission of fee
7500/- for revision of specifications.
• Manufacturer shall perform dissolution testing as per USFDA on commercial batches.
434. Name, address of Applicant / M/s Hiranis Pharmaceuticals (Pvt) Ltd

Name, address of Manufacturing M/s Hiranis Pharmaceuticals (Pvt) Ltd
site. Plot E-145-149, North western industrial zone,
Port Qasim, Karachi.
☐ Importer
giver)
Tapento Tablet 50mg
brand name
Active Pharmaceutical ingredient Tapentadol HCl equivalent to Tapentadol
(API) per unit ………50mg
Opioid Analgesics
(API)
Manufacturer’s Spec.
specifications
US-FDA Approved.
authorities

GMP status of the Finished product DML by way of formulation No. 000785 dated
manufacturer 03-02-2019
Name and address of API Tapentadol HCL
manufacturer. M/s. AMI Lifesciences Private Limited.
Address꞉ Block no. 82/B, ECP Road, AT &
Post꞉ Karakhadi-391450. Taluka꞉ Padra,
District Vadodara Gujarat, India.
submitted.
Module III (Drug Substance) Official monograph is not present in any
pharmacopeia. The firm has submitted detail of
controls,), specifications, analytical procedures
Tapentadol HCl:
months
months
Batches:
Tapentadol HCl:
TPT/50040513, TPT/50050513,
TPT/50060513.
product.
Nucynta 50mg Tablet by Endo Ventures
Tablet by performing quality tests
(Identification, Assay, Dissolution, and

brand that is Nucynta 50mg Tablet by Endo
Ventures Tablet in Acid media (0.1 N HCL) &
Acetate Buffer (pH 4.5) & Phosphate Buffer
(pH 6.8). F2value calculation is not required as
reference and test products released more than
85% within 15 minutes.
specificity.
Manufacturer of API Tapentadol HCL
M/s. AMI Lifesciences Private Limited.
Address꞉ Block no. 82/B, ECP Road, AT & Post꞉ Karakhadi-
391450. Taluka꞉ Padra, District Vadodara Gujarat, India.
API Lot No. Tapentadol HCl:
TPT/50141018
Description of Pack
Batch No. TF-021219 TF-031219 TF-041219
No. of Batches 03
1. Reference of previous approval of Etoxib 90mg Tablet
applications with stability study data Etoxib 120mg Tablet
of the firm (if any) Approved in 294th minutes of meeting of DRB
2. Approval of API/ DML/GMP Tapentadol HCl:
certificate of API manufacturer Copy of GMP certificate No. 19041306 issued
issued by concerned regulatory by Food and Drugs Control Administration
authority of country of origin. Gujarat valid till 24/04/2022.
3. Documents for the procurement of Attested invoice from ADC attached for
API with approval from DRAP (in Tapentadol HCl Invoice No. EXP/A/064/2018-
case of import). 19
data sheets etc.
5. Compliance Record of HPLC The firm has submitted compliance record of
software 21CFR & audit trail reports HPLC software 21

drug product.
temperature and humidity monitoring temperature and
of stability chambers (real time and humidity monitoring of real time and
chambers.
Remarks OF Evaluator VI:
• - The submitted dissolution condition is • Dissolution medium proposed by
different from the innovators’. innovator is 0.1M HCI, while our is 0.1N HCI,
Dissolution conditions of innovator as per both are same and there is no difference.
Biopharmaceutics Review: • Dissolution medium volume proposed
Apparatus: Type I (Basket apparatus) by innovator is 900ml, while our is also 900ml,
Spindle rotation: 75 RPM both are same & there is no difference.
Medium: 0.1 M HCl • Dissolution time proposed by innovator
Medium volume: 900ml is 45 minutes, while our is 15 minutes which is
Time: 45 min shorter than innovator, it is acceptable in
Acceptance criteria: NLT 80% (Q) of the labelled accordance to USP Chapter <711> Dissolution
amount of Tapentadol (as HCl) dissolved in 45 min under procedure Apparatus 1 and Apparatus 2;
IMMEDIATE-RELEASE DOSAGE FORMS,
refer to:
Time: Where a single time specification is
given, the test may be concluded in a shorter
period if the requirement for the minimum
amount dissolved is met.
Therefore, proposed dissolution time in our
specification is justified & acceptable.
• Acceptance criteria is NLT 80% (Q) in
both scenario and acceptable % drug release is
same, no difference.
• Apparatus type and rpm is different in
both cases, please note that while reviewing
"Clinical pharmacology & Biopharmaceutics
review" by "Center of drug evaluation and
research", Application number 22-304
(submission date 16-09-2008); it was found that
manufacturer performed dissolution test at
various condition, including our condition 50
rpm with paddle.
• 3.2.S.4 Control of Drug Substance: - You We already have submitted Raw Material
have submitted finished product specification and testing method of Tapentadol
specifications, COA, analytical method Hydrochloride with Certificate of Analysis
etc. instead of providing drug substance (CoA) by both, drug substance manufacturer and
information. drug product manufacturer, now as per your
requirement we are hereby re submitting the
drug substance information

• Manufacturer will revise dissolution specifications as per USFDA along with submission of
fee 7500/- for revision of specifications.
• Manufacturer shall perform dissolution testing as per USFDA for commercial batches.
435. Name, address of Applicant / M/s Saffron Pharmaceutical 19 km,
Marketing Authorization Holder Sheikhupura Road, Faisalabad.
Name, address of Manufacturing M/s Saffron Pharmaceutical 19 km,
site. Sheikhupura Road, Faisalabad.
Status of the applicant ☒ Manufacturer √
☐ Importer
giver)
Dy. No. and date of submission Dy.No 24058, Dated 01.09.2021
Details of fee submitted Rs.75,000/- dated 29.06.2021 Deposit Slip #
3849293923
Rupasaf 1mg/mL Oral Solution
brand name
Strength / concentration of drug of Each mL contains
Active Pharmaceutical ingredient Rupatadine Fumarate equivalent to
(API) per unit Rupatadine…………………… 1.0 mg
Pharmaceutical form of applied drug Oral Solution
Pharmacotherapeutic Group of (API) Antihistamine
Manufacturer’s Specifications
specifications
Proposed Pack size 60mL & 120mL
Approved MHRA
authorities
GMP status of the Finished product GMP certificate issued on 03.01.2022
manufacturer Good Compliance
Name and address of API Name: M/s Vasudha Pharma Chem Limited,
manufacturer. Address: 78/A, Vengalrao Nagar, Hyderabad-
500 038, Telangana State, INDIA
Telephone: +91 40 44763666 / 23711717
Fax: +91 40 23811576
E-mail: vasudha@vasudhapharma.com

product.
substance.
Stability studies Rupatadine Fumarate: Firm has submitted
stability study data of 3 batches of drug
substance at both accelerated as well as real
months. The real time stability data is conducted
at 30°C ± 2°C / 65 ± 5% RH for 60 months.
and stability.
Pharmaceutical equivalence and Pharmaceutical Equivalence Studies s against
comparative dissolution profile the reference product of “Rupall 1mg/mL Oral
Solution”.
Manufacturer of API Name: M/s Vasudha Pharma Chem Limited,
Address: 78/A, Vengalrao Nagar, Hyderabad- 500 038,
Telangana State, INDIA
Telephone: +91 40 44763666 / 23711717
Fax: +91 40 23811576
API Lot No. BRPFA/1911009
Description of Pack API Container: Double polythene bags (as primary
(Container closure system) packaging material) and kept in HDPE container.
Product Container: Amber glass bottles sealed with P.P caps
and packed in card board carton

Batch No. T-001 T-002 T-003
Batch Size 2.40 L 2.40 L 2.40 L
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report
applications with stability study data for Elixa (Apixaban) 2.5mg & 5mg conducted
of the firm (if any) on 08.10.2019, approved in 293rd meeting of
Registration Board.
Following are details of few points;

• The HPLC software is 21CFR
Compliant.
• Audit trail reports were available and
physically checked by the inspection
team.
• Firm has adequate monitoring and
controls for stability chambers.
• Software is installed for continuous
monitoring of chambers.
2. Approval of API/ DML/GMP Copy of GMP certificate (Certificate#
certificate of API manufacturer issued 46/VP/AP/2007/B/R) issued by Govt. of
by concerned regulatory authority of Andhrapradesh, INDIA, valid upto 30.12.2022
country of origin.
3. Documents for the procurement of Copy of commercial invoice attested by AD
API with approval from DRAP (in I&E DRAP, Lahore has been submitted.
case of import). Rupatadine Fumarate:
Date of
Quantity
Batch No. approval
Imported
by DRAP
BRPFA/1911009 100gm 14.10.2019
supported by attested respective along with batch manufacturing record and
documents like chromatograms, analytical record.
sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail reports on
software 21CFR & audit trail reports product testing.
on product testing
6. Record of Digital data logger for Firm has submitted Record of Digital data
temperature and humidity monitoring logger for temperature & humidity monitoring
of stability chambers (real time and of stability chambers (real time and
accelerated) accelerated)

SUBMITTED DATA REGARDING THE DEFICIENCIES
7. Copy of GMP certificate (Certificate#

Valid GMP Certificate of finish
46/VP/AP/2007/B/R) issued by Govt. of
product and API manufacturer.
Andhrapradesh, INDIA, valid upto 30.12.2022
8. Specification for testing of Rupatadine Fumarate
manufactured at Vasudh Pharma is adopted from
Ph. Eur monograph.
3.2.S.4 you are using in house Assay by HPLC method of In-House developed
specifications for some tests whereas is adopted to estimate the assay of Rupatadine.
the drug substance is present in British Analytical method validation report for the assay
Pharmacopoeia. Justification is by HPLC method is performed and verification
required for not following the report is provided.
pharmacopoeia and compares the An In-house GC method was developed for
limits and both specifications. estimation of residual solvents in Rupatadine
Fumarate. Analytical method validation for the
residual solvents by GC method was performed
and validation report is provided.
9.
3.2.P.2 Invoice are required for the Firm has submitted Unit pack innovator product
procurement of innovator’s product. Rupall Oral Solution
• Registration letter will be issued upon submission of revised drug substance analytical
method, analytical method verification studies & drug substance analysis report as per
European Pharmacopoeia Monograph for “Rupatadine Fumarate”.
436. Name, address of Applicant / M/s Saffron Pharmaceutical 19 km,
Marketing Authorization Holder Sheikhupura Road, Faisalabad.
Name, address of Manufacturing M/s Saffron Pharmaceutical 19 km, Sheikhupura
site. Road, Faisalabad.
Status of the applicant ☒ Manufacturer √
☐ Importer
giver)
Dy. No. and date of submission Dy.No 24059, Dated 01.09.2021
Details of fee submitted Rs.75,000/- dated 10.06.2021 Deposit Slip #
10200204449

Rupasaf 10mg Tablet
brand name
Strength / concentration of drug of Each tablet contains
Active Pharmaceutical ingredient Rupatadine Fumarate equivalent to
(API) per unit Rupatadine…………………….10 mg
Oral Tablet
drug
Antihistamine
(API)
Manufacturer’s Specifications
specifications
Proposed Pack size 2x7’s, 2x14’s & 3x10’s
Approved by UK MHRA
authorities
GMP status of the Finished product GMP certificate issued on 03.01.2022
manufacturer Good Compliance
Name and address of API Name: Vasudha Pharma Chem Limited,
manufacturer. Address: 78/A, Vengalrao Nagar, Hyderabad-
500 038, Telangana State, INDIA
Telephone: +91 40 44763666 / 23711717
Fax: +91 40 23811576
product.
substance.
Stability studies Rupatadine Fumarate: Firm has submitted
stability study data of 3 batches of drug
substance at both accelerated as well as real time
conditions. The accelerated stability data is

months. The real time stability data is conducted
at 30°C ± 2°C / 65 ± 5% RH for 60 months.
stability.
Pharmaceutical equivalence and Pharmaceutical Equivalence Studies s against
comparative dissolution profile the reference product of “Rupall 10mg Tablet”.
Manufacturer of API Name: M/s Vasudha Pharma Chem Limited,
Address: 78/A, Vengalrao Nagar, Hyderabad- 500 038,
Telangana State, INDIA
Telephone: +91 40 44763666 / 23711717
Fax: +91 40 23811576
API Lot No. BRPFA/1911009
Description of Pack API Container: Double polythene bags (as primary
(Container closure system) packaging material) and kept in HDPE container.
Product Container: Alu-PVC blister packed in unit carton
(2x7’s, 2x14’s & 3x10’s)
Batch No. T-001 T-002 T-003
Tablets
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report
applications with stability study data for Elixa (Apixaban) 2.5mg & 5mg conducted on
of the firm (if any) 08.10.2019, approved in 293rd meeting of
Registration Board.

• The HPLC software is 21CFR
Compliant.
team.
2. Approval of API/ DML/GMP Copy of GMP certificate (Certificate#
certificate of API manufacturer 46/VP/AP/2007/B/R) issued by Govt. of
issued by concerned regulatory Andhrapradesh, INDIA, valid upto 30.12.2022
3. Documents for the procurement of Copy of commercial invoice attested by AD
API with approval from DRAP (in I&E DRAP, Lahore has been submitted.
case of import). Rupatadine Fumarate:
Date of
Quantity
Batch No. approval
Imported
by DRAP
BRPFA/1911009 100gm 14.10.2019
supported by attested respective along with batch manufacturing record and
documents like chromatograms, analytical record.
data sheets etc.
5. Compliance Record of HPLC Firm has submitted audit trail reports on
software 21CFR & audit trail reports product testing.
on product testing
6. Record of Digital data logger for Firm has submitted Record of Digital data
temperature and humidity logger for temperature & humidity monitoring
monitoring of stability chambers of stability chambers (real time and accelerated)
SUBMITTED DATA REGARDING THE DEFICIENCIES

7. Copy of GMP certificate (Certificate#
Valid GMP Certificate of finish
46/VP/AP/2007/B/R) issued by Govt. of
product and API manufacturer.
Andhrapradesh, INDIA, valid upto 30.12.2022
8. Specification for testing of Rupatadine Fumarate
manufactured at Vasudh Pharma is adopted
from Ph. Eur monograph.
3.2.S.4 you are using in house Assay by HPLC method of In-House developed
specifications for some tests whereas is adopted to estimate the assay of Rupatadine.
the drug substance is present in Analytical method validation report for the
British Pharmacopoeia. Justification assay by HPLC method is performed and
is required for not following the verification report is provided.
pharmacopoeia and compares the An In-house GC method was developed for
limits and both specifications. estimation of residual solvents in Rupatadine
Fumarate. Analytical method validation for the
residual solvents by GC method was performed
and validation report is provided.
9. 3.2.P.2 Invoice are required for the
procurement of innovator’s product.

Firm has submitted Unit pack/Invoice of
innovator product Rupall Tablet
• Registration letter will be issued upon submission of revised drug substance analytical
method, analytical method verification studies & drug substance analysis report as per
European Pharmacopoeia Monograph for “Rupatadine Fumarate”.
437. Name, address of Applicant / M/s Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-
Marketing Authorization 129, North Western Industrial Zone, Bin Qasim,
Holder Karachi-75020, Pakistan.
Name, address of Manufacturing Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
site. North Western Industrial Zone, Bin Qasim,
Karachi-75020, Pakistan.
☐ Importer
Cardrone 400mg tablet
brand name
Strength / concentration of drug Each film coated tablet contains
of Active Pharmaceutical Dronedarone HCL eq to Dronedarone….400mg
ingredient (API) per unit
Pharmaceutical form of applied Cream white color oval shaped film tablet coated
drug tablet
Class III antiarrhythmic agent
(API)
USP specifications
specifications
Proposed Pack size 10’s, 20’s, 30’s (as per SRO)
The status in reference
Multaq 400mg tablet by Sanofi,Ambares (France)
regulatory authorities
For generic drugs (me-too status) -------

GMP status of the Finished New license granted on 16/09/2020
product manufacturer Tablet (General & General Antibiotic) section
approved.
Name and address of API M/s Piramal enterprises limited, Digwal
manufacturer. village(Sy.Nos.7-70,70/1 and 70/2), kohir
Mandal, Medak dist.,502 321 Telangana, India
Module III (Drug Substance) Official monograph of Dronedarone is present in
USP 40 vol.4. The firm as submitted detail of
, specifications, analytical procedures and its
months
months
Batches:(DD04/00216,DD04/00316,DD04/00416)
comparative dissolution profile against the brand leader that is Multaq 400mg
tablet by Sanofi performing quality tests
dosage form).
that is Multaq 400mg Tablet by Sanofi in Acid
media (pH 0.1N HCl) & Phosphate Buffer (pH 6.8,
range.
validation/verification of product including linearity, accuracy, precision,
specificity,LOD)

Manufacturer of API Piramal enterprises limited, Digwal village (Sy.Nos.7-
70,70/1 and 70/2), kohir Mandal, Medak dist.,502 321
Telangana, India
API Lot No. N/A
Description of Pack
PVDC/ aluminum blister pack (10’s, 20’s, 30’s)
Real Time: 0, 3, 6, 9, 12, 18(Months)
Batch No. TF-02 TF-03 TF-04
Manufacturing Date 18-01- 30-01-2019 30-01-2019
2019
15-02-2019 15-02-2019
2019
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last onsite inspection
applications with stability study conducted for product Rofair (Roflumilast)
data of the firm (if any) 500mcg Tablets on 25th June, 2019. The said
inspection report was discussed in 290th meeting of
Registration Board held on 3rd–4th July, 2019 and
the case was approved.
The inspection report confirms following points:
• The firm has Shimadzu ‘s LC 20A, with software
―Lab solution DB‖ which is 21 CFR part 11
compliant with audit trail and date time stamped
and
with complete multi-level user authorization
monitored through software having alarm system
for alerts as well.
2. Approval of API/ DML/GMP L.Dis.No.3686/E(S)/TS/2017 issued to primal
certificate of API manufacturer enterprises limited province FDA valid till 07-06-
issued by concerned regulatory 2019
3. Documents for the procurement Form 6 license no. 0469 dated 11-02-2019
of API with approval from DRAP
(in case of import).

supported by attested respective along with
data sheets etc.
5. Compliance Record of HPLC The firm has submitted compliance record of
software 21CFR & audit trailHPLC software 21
reports on product testing CFR and copies of audit trail on testing of drug
product.
temperature and humidity temperature and
monitoring of stability chambers humidity monitoring of real time and accelerated
(real time and accelerated) stability
chambers.
Short coming Replies
• 3.2.P Which API polymorphic form • Only one polymorphic form has been
was used by you in formulation found. Solubility of Dronedarone HCl is
development and how do you know the greater in water than in buffers but in all
API polymorphic form was used by the cases it is practically insoluble. Only one
innovator? Submit testing reports if polymorphic form was available as
you have performed any specific test described in the TGA document. Attached
• 3.2.P.2.1.2 Discussion of the choice of for your reference.
excipients, their concentration and • We have added : hypromellose, starch,
characteristics that can influence the crospovidone, poloxamer 407, lactose
Drug Product performance shall be monohydrate, colloidal silicon dioxide,
provided. magnesium stearate polyethylene glycol
6000, titanium dioxide, carnauba wax
• 3.2.P.2 Invoice is required for the
procurement of innovator’s product. • We procured Innovator’s product from a
personal resource.
Decision: Approved.
438. Name, address of Applicant / M/s Scotmann Pharmaceuticals, 5-D, I-10/3,

Marketing Authorization Holder Industrial Area, Islamabad, Pakistan
Name, address of Manufacturing M/s Scotmann Pharmaceuticals, 5-D, I-10/3,
site. Industrial Area, Islamabad, Pakistan
☐ Importer
giver)

Esonap DR Tablets 500/20mg
brand name
Strength / concentration of drug of Each Delayed Release Tablet contains:
Active Pharmaceutical ingredient Naproxen………...500mg
(API) per unit Esomeprazole as magnesium…….20mg
Pharmaceutical form of applied drug Delayed Release Tablet
Pharmacotherapeutic Group of Naproxen: Non-steroidal anti-inflammatory
(API) drug
Esomeprazole: Proton pump inhibitor
Innovator specification
specifications
The status in reference regulatory Vimovo DR Tablet 500/20mg Manufacturer
authorities Horizon Pharma USA, Inc.,
manufacturer Tablet section approved.
Name and address of API Name: M/s EVEREST ORGANIC
manufacturer. LIMITED.
Address: AROOR VILLAGE,
SADASIVAPET MANDAL,
SANGAREDDY DIST, AROOR(V)
SADASIVPET(M),
SANGAREDDY(DIST.),502291
Contact Person: DR BOLLAM
VENKATESWARLU
Summary) PD template. Summarized information related
Module III (Drug Substance) Official monograph of Naproxen and
Esomeprazole present in USP. The firm as

months
months
Batches: (T-01, T-02, T-03)
Vimovo DR Tablets 500/20mg by Horizon
Pharma USA, Inc. performing quality tests
(Identification, Dissolution, Assay).
brand that is Vimovo Tablets 500/20mg by
Horizon Pharma USA, Inc, Dissolution
profiles of both products (Vimovo Tablets
500/20mg and Esonap DR Tablets 500/20mg)
validation/verification of product including linearity, Robustness, accuracy,
linearity, precision (Repeatability),
specificity.
Manufacturer of API Name: M/s EVEREST ORGANIC LIMITED.
Address: AROOR VILLAGE, SADASIVAPET
MANDAL, SANGAREDDY DIST, AROOR(V)
SADASIVPET(M), SANGAREDDY(DIST),502291
Contact Person: DR BOLLAM VENKATESWARLU
API Lot No. Naproxen: ANMA000240
Esomeprazole: ESM/E-108/19
Description of Pack Alu-Alu blister with cold aluminum foil (7’s, 10’s, 14’s,
(Container closure system) 20’s, 28’s & 30’s)
Stability Storage Condition Long term: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: Initial,1,2 3,4, 6 (Months)

Tablets
17-02-2020 19-02-2020
2020
No. of Batches 03
1. Reference of previous approval of Mekolade Tablets containing Metolazone
applications with stability study data 5mg
of the firm (if any) DRAP Registration no. 108059
2. Approval of API/ DML/GMP Copy of GMP certificate No. 42005/TS/2020
certificate of API manufacturer issued by Drugs control Administration
issued by concerned regulatory (Telangana State)
Issue & Valid Upto Dt: 30/07/2020 -
30/07/2021
3. Documents for the procurement of Letter to Assistant Director (I&E) (R&I
API with approval from DRAP (in dated; Naproxen: 20/11/2019 and
case of import). Esomeprazole: 29-01-2019) is submitted
wherein the permission to import different
APIs including Naproxen and Esomeprazole
studies is granted.
data sheets, COA, summary data summary data sheets
sheets etc.
5. Compliance Record of HPLC The firm has submitted compliance record
software 21CFR & audit trail reports of HPLC software 21
drug product.
of stability chambers (real time and humidity monitoring of real time and
chambers.
Remarks Of Evaluator:
Dissolution was according to USFDA. Details are as under
Dissolution 1 (naproxen at core), Dissolution 2 (naproxen at coating stage),Dissolution 3

(esomeprazole at coating stage)
Decision:
Decision: Approved.

439. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited, 7-
Authorization Holder Jail Road, Quetta
Name, address of Manufacturing site. M/s Martin Dow Marker Limited,
F-126, S. I. T. E., Karachi, Pakistan
☐ Importer
(contract giver)
☐ Export sale
PKR 25,000/-: dated 30/06/2021
ADVITA 200,000 IU CAPSULES
name
Strength / concentration of drug of Active Each Soft gel Capsule contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol…...200,000 IU
Pharmaceutical form of applied drug Clear light-yellow oily liquid
Pharmacotherapeutic Group of (API) Vitamin D analogs
USP
specifications
The status in reference regulatory Fultium 20,0000 IU Capsule by M/s
authorities Internis Pharmaceuticals Limited, MHRA
Approved.
GMP status of the Finished product Certificate No: F.14-
manufacturer 1/DRAP/GMP/MDM-2022 issued on
03rd Feb 2022
Soft Gelatin Capsule (General)
Dispensing, Mixing, Drying, Granulation,
Compression, Coating, Blistering &
Packaging.
Name and address of API manufacturer. M/s DSM Nutritional Product, France

Module III (Drug Substance) The firm has submitted detail of
Real time: 25°C ± 2°C / 60% RH ± 5%
RH for 24 months
Accelerated: 30°C ± 2°C / 65% RH ± 5%
RH for 6 months

procedure, verification studies, batch
product.
Fultium 20,0000 IU Capsule by M/s
Internis Pharmaceuticals Limited.
Since Vitamin D3 capsules are Fat soluble
in nature so the dissolution in not
recommended by any Pharmacopoeia &
FDA dissolution guideline.
Analytical method validation/verification Method validation studies have submitted
Manufacturer of API M/s DSM Nutritional Product, France
API Lot No. 11F01901004
Description of Pack
Aluminum foil with PVC/PVDC blister (2×7’s)

Batch No. TR-007/20 TR-008/20 TR-009/20
Batch Size 10000 10000 capsule 10000 capsule
capsule
No. of Batches 03
applications with stability study data of the Dexlansoprazole was approved in 312th
firm (if any) Registration Board meeting.

reports on product testing were
present
2. Approval of API/ DML/GMP certificate of GMP Certificate No 18MPP077HFR02
API manufacturer issued by concerned issued by EUDRA . Period of validity is
regulatory authority of country of origin. extended to 26.09.2023 in case of
cholecalciferol .
3. Documents for the procurement of API with M/s DSM Nutritional Product, France
approval from DRAP (in case of import). ADC Invoice No: 2831239200, 29-08-
2019
Raw data sheets, COA, summary data and summary data sheets
sheets etc.
testing CFR and copies of audit trail on testing
of drug product.
• Clarification of conditions of stability studies of drug substance and drug product.
• Justification why comparative dissolution profile studies are not performed against
the innovator drug product.

440. Name, address of Applicant / Marketing M/s Rogen Pharmaceuticals Plot No. 30, S-4,
Authorization Holder National Industrial Zone, Rawat Islamabad "
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd Plot #
Islamabad"
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 50,000/-: 03-03-2020 (#2005272)
P-Becten Injection IV 4.5gm
name
Strength / concentration of drug of Active Each Glass vial contains:
Pharmaceutical ingredient (API) per unit Piperacillin Sodium eq. to Piperacillin ………. 4
gm
Tazobactam Sodium eq. to Tazobactam ………
…… 0.5 gm
Pharmaceutical form of applied drug Lyophilized powder for injection/infusion
USP Specification
specifications
Proposed Pack size Glass vial USP type II partially sealed by rubber
stopper and fully sealed by flip off seal.
1’s
The status in reference regulatory Piperacillin/Tazobactam 4 g/0.5 g powder for
authorities solution for infusion
MHRA Approved
For generic drugs (me-too status) Zoycin Injection 4.5gm By M/S Global
Pharmaceuticals (Pvt) Ltd
Reg No: 066599
GMP status of the Finished product Global pharmaceuticals: Firm has submitted
manufacturer copy of GMP certificate dated 04-01-2022. The
certificate was issued based on the inspection
dated 03-01-2022. The certificate specifies dry
powder injection penicillin section.
Name and address of API manufacturer. M/s Nectar Lifesciences Ltd., (Unit No. 1)
village
saidpura Tehsil Derabassi District Sahibzada
Ajit Singh
Nagar Punjab India

submitted.
substance
(Conditions & duration of Stability studies) batches of
drug substance at both accelerated as well as
real time
conducted at
40°C ± 2°C / 75% ± 5% RH for 6 months. The
real time
stability data is conducted at 30°C ± 2°C / 65 ±
5% RH
for 36 months
comparative dissolution profile established against the reference product Zosyn
Injection 4.5gm by M/s Pfizer Pharmaceuticals,
by performing quality tests (Identification,
Assay, Dissolution, Uniformity of dosage form).
specificity.
Manufacturer of API M/s Nectar Lifesciences Ltd., (Unit No. 1)
village saidpura Tehsil Derabassi District
Sahibzada Ajit Singh Nagar Punjab India.
API Lot No. TSP13000616N

Description of Pack
Type II Glass VIAL (1s)
Frequency Accelerated: 0, 1, 2, 3, 4, 5, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H011 21H012 21H013
Batch Size 4120 4120 Vial 4120 Vial
Vial
2021
31-08-2021 04-09-2021
2021
No. of Batches 03
1. Reference of previous approval of PIPRABEN Injection 4.5g Injection
applications with stability study data of the (Piperacillin + Tazobactum)Approved in
firm (if any) 316th Registration Board meeting.
Applicant is : M/s Benson Pharmaceuticals Plot

No. 3, Main Road,
National Industrial Zone, RCCI, Rawat.
Manufacturer:
M/s Global Pharmaceuticals (Pvt) Ltd. Plot
No. 204-205, Industrial Triangle Kahuta Road
Islamabad.
API manufacturer issued by concerned (No. Pb.2019/5422) issued by Food and Drugs
regulatory authority of country of origin. Administration Punjab dated 04-12-2019. The
certificate is valid till 2 years from the date of
issue.
3. Documents for the procurement of API with Firm has submitted copy ADC, duly endorsed
approval from DRAP (in case of import). by AD (1&E) Dated: 20-05-2021, Diary No:
1643
4. Data of stability batches will be supported Firm has submitted record of testing of batches
by attested respective documents like along with
summary data sheets etc. summary data sheets
21CFR & audit trail reports on product HPLC software 21
drug product.
chambers.

Evaluation by PEC:
Valid GMP certificate of finish product and API manufacturer Firm has submitted copy of GMP
certificate (No.Drugs (3)
Pb.2021/6335) issued by Food and
Drugs Administration Punjab dated
01-19-2021. The certificate is valid
till 2 years from the date of issue.
3.2.P.2 Invoice are required for the procurement of innovator Invoice for procurement of API
product Provided
Decision: Approved. Registration Board Authorized its Chairman for issuance of registration letter
upon capacity assessment of manufacturing and testing facility of M/s Global Pharmaceuticals (Pvt)
441. Name, address of Applicant / Marketing M/s Rogen Pharmaceuticals
Authorization Holder Plot No. 30, S-4, National Industrial Zone,
Rawat Islamabad "
Islamabad"
☐ Importer
giver)
☐ Export sale
Details of fee submitted PKR 50,000/-: 25-02-2021 (#2005274)
P-Becten Injection IV 2.25 gm
name
Pharmaceutical ingredient (API) per unit Piperacillin Sodium eq. to
Piperacillin…………….2 gm
Tazobactam Sodium eq. to
Tazobactam……………0.25 gm
USP Specification
specifications
1’s

MHRA Approved
For generic drugs (me-too status) Tazop Injection of Global Pharmaceuticals
village
Ajit Singh
Nagar Punjab India
submitted.
substance
real time
conducted at
real time
5% RH
for 36 months


Injection 4.5gm by Pfizer Pharmaceuticals, by
performing quality tests (Identification, Assay,
specificity.
API Lot No. 2105R0069, 2105R0070
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H008 21H009 21H128
Vial
2021
Date of Initiation 01-09- 31-08-2021 30-08-2021
2021
No. of Batches 03

No. 3, Main Road,
Manufacturer:
Islamabad.

issue.
1643
drug product.
chambers.
Evaluation by PEC:
product Provided
442. Name, address of Applicant / Marketing M/s Carer Pharmaceuticals Industries Plot
Authorization Holder # 27, Main Road Rawat-Islamabad"
Islamabad"
☐ Importer
giver)
☐ Export sale

Details of fee submitted PKR 50,000/-: dated 08/03/2021 (#2077511)
Salutem Injection IV 4.5gm
name
Pharmaceutical ingredient (API) per unit Piperacillin Sodium eq. to Piperacilli……….4
gm
USP Specification
specifications
1’s
MHRA Approved
Reg No: 066599
village
Ajit Singh
Nagar Punjab India
submitted.

substance
real time
conducted at
real time
5% RH
for 36 months
specificity.
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H011 21H012 21H013
Vial
2021

31-08-2021 04-09-2021
2021
No. of Batches 03

No. 3, Main Road,
Manufacturer:
Islamabad.
API manufacturer issued by concerned (No.Drugs (3) Pb.2021/6335) issued by Food
regulatory authority of country of origin. and Drugs Administration Punjab dated 01-19-
2021. The certificate is valid till 2 years from
the date of issue..
1643
drug product.
chambers.
Evaluation by PEC:
Valid GMP certificate of finish product and API manufacturer Valid GMP Certificate till 31-12-
2022 Provided.
product Provided
443. Name, address of Applicant / Marketing M/s Carer Pharmaceuticals Industries Plot
Authorization Holder # 27, Main Road Rawat-Islamabad"

Islamabad"
☐ Importer
giver)
☐ Export sale
Dy. No. and date of submission PKR 50,000/-: dated 08/03/2021 (2077512)
Details of fee submitted Salutem Injection IV 2.5gm
P-Becten Injection IV 2.25 gm
name
Pharmaceutical ingredient (API) per unit Piperacillin Sodium eq. to
Piperacillin…………….2 gm
USP Specification
specifications
1’s
MHRA Approved
village
Ajit Singh
Nagar Punjab India

submitted.
substance
real time
conducted at
real time
5% RH
for 36 months
specificity.
API Lot No. 2105R0069, 2105R0070
Description of Pack

Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H008 21H009 21H128
Vial
2021
Date of Initiation 01-09- 31-08-2021 30-08-2021
2021
No. of Batches 03

No. 3, Main Road,
Manufacturer:
Islamabad.
the date of issue.
1643
drug product.
chambers.
Evaluation by PEC:

certificate (No. Pb.2019/5422) issued
by Food and Drugs Administration
Punjab dated 04-12-2019. The
certificate is valid till 2 years from
the date of issue.
product Provided
444. Name, address of Applicant / Marketing M/s Nagarsons Pharmaceuticals (Pvt) Ltd
Authorization Holder Plot # 34, Street No. NS-2, National Industrial
Zone, Rawat-Islamabad"
Islamabad"
☐ Importer
giver)
☐ Export sale
Darrel Injection IV 4.5gm
name
Pharmaceutical ingredient (API) per unit Piperacillin Sodium eq. to Piperacilli……….4
gm
USP Specification
specifications
1’s

MHRA Approved
Reg No: 066599
village
Ajit Singh
Nagar Punjab India
submitted.
substance
real time
conducted at
real time
5% RH
for 36 months


specificity.
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H011 21H012 21H013
Vial
2021
31-08-2021 04-09-2021
2021
No. of Batches 03

No. 3, Main Road,
Manufacturer:
Islamabad.

the date of issue.
1643
drug product.
chambers.
Evaluation by PEC:
certificate (No. Pb.2019/5422) issued
by Food and Drugs Administration
Punjab dated 04-12-2019. The
certificate is valid till 2 years from
the date of issue.
product Provided
445. Name, address of Applicant / Marketing M/s Swiss Pharmaceuticals (Pvt) Ltd
Authorization Holder A/159, S.I.T.E-II, Super Highway, Karachi-
Pakistan "
Islamabad"
☐ Importer
giver)

☐ Export sale
Pectaz Injection IV 4.5gm
name
Pharmaceutical ingredient (API) per unit Piperacillin Sodium eq. to Piperacillin……….4
gm
Tazobactam………0.5 gm
USP Specification
specifications
1’s
MHRA Approved
Reg No: 066599
village
Ajit Singh
Nagar Punjab India
submitted.

substance
real time
conducted at
real time
5% RH
for 36 months
specificity.
Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H011 21H012 21H013
Vial

2021
31-08-2021 04-09-2021
2021
No. of Batches 03

No. 3, Main Road,
Manufacturer:
Islamabad.
issue.
1643
drug product.
chambers.
Evaluation by PEC:
product Provided

446. Name, address of Applicant / M/s Swiss Pharmaceuticals (Pvt) Ltd

Marketing Authorization Holder A/159, S.I.T.E-II, Super Highway, Karachi-
Pakistan "
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd Plot # 204-
205, Industrial Triangle, Kahuta Road, Islamabad"
☐ Importer
Pectaz Injection IV 2.25 gm
brand name
Strength / concentration of drug of Each Glass vial contains:
Active Pharmaceutical ingredient Piperacillin Sodium eq. to Piperacillin…………….2
(API) per unit gm
USP Specification
specifications
1’s
The status in reference regulatory Piperacillin/Tazobactam 4 g/0.5 g powder for solution
authorities for infusion
MHRA Approved
GMP status of the Finished product Global pharmaceuticals: Firm has submitted copy of
manufacturer GMP certificate dated 04-01-2022. The certificate was
issued based on the inspection dated 03-01-2022. The
certificate specifies dry powder injection penicillin
section.
Name and address of API M/s Nectar Lifesciences Ltd., (Unit No. 1) village
manufacturer. saidpura Tehsil Derabassi District Sahibzada Ajit
Singh

Nagar Punjab India
substance
(Conditions & duration of Stability of
studies) drug substance at both accelerated as well as real
time
conducted at
40°C ± 2°C / 75% ± 5% RH for 6 months. The real
time
stability data is conducted at 30°C ± 2°C / 65 ± 5%
RH
for 36 months
product.
comparative dissolution profile against the reference product Zosyn Injection 4.5gm
by Pfizer Pharmaceuticals, by performing quality tests
dosage form).
Manufacturer of API M/s Nectar Lifesciences Ltd., (Unit No. 1) village
saidpura Tehsil Derabassi District Sahibzada Ajit
Singh Nagar Punjab India.
API Lot No. 2105R0069, 2105R0070

Description of Pack
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 21H008 21H009 21H128
Batch Size 4120 Vial 4120 Vial 4120 Vial
No. of Batches 03
1. Reference of previous approval of PIPRABEN Injection 4.5g Injection (Piperacillin
applications with stability study data of + Tazobactum)Approved in 316th Registration
the firm (if any) Board meeting.
Applicant is : M/s Benson Pharmaceuticals Plot No.

3, Main Road,
Manufacturer:
M/s Global Pharmaceuticals (Pvt) Ltd. Plot No.
Islamabad.
certificate of API manufacturer issued Pb.2019/5422) issued by Food and Drugs
by concerned regulatory authority of Administration Punjab dated 04-12-2019. The
3. Documents for the procurement of API Firm has submitted copy ADC, duly endorsed by AD
with approval from DRAP (in case of (1&E) Dated: 20-05-2021, Diary No: 1643
import).
supported by attested respective along with
etc.
5. Compliance Record of HPLC softwareThe firm has submitted compliance record of HPLC
software 21
testing CFR and copies of audit trail on testing of drug
product.
of stability chambers (real time and humidity monitoring of real time and accelerated
accelerated) stability
chambers.
Evaluation by PEC:

product Provided
447. Name, address of Applicant / M/s Horizon Healthcare (Pvt.) Ltd.

Marketing Authorization Plot no. 33 Sundar Industrial Estate Lahore.
Holder
Name, address of M/s Horizon Healthcare (Pvt.) Ltd.
Manufacturing site. Plot no. 33 Sundar Industrial Estate Lahore.
☐ Importer
Intended use of ☒Domestic sale
pharmaceutical product ☐ Export sale
☐Domestic and Export sales
Dy. No. and date of Dy.No 16908 dated 24-12-2021
submission
The proposed proprietary
name / brand name Sinzon-S tablet 6.0/0.4mg
Strength / concentration of Each Film Coated Tablet contains:
drug of Active Solifenacin Succinate(Immediate Release…….6.0mg Tamsulosin
Pharmaceutical ingredient HCl (modified Release)………….0.4mg
(API) per unit
Pharmaceutical form of
applied drug Dark red colored round biconvex film coated tablet.
Pharmacotherapeutic Group Solifenacin Succinate: Urologicals, Drugs for urinary frequency

of (API) and incontinence
Tamsulosin HCl: Adrenergic ɑ 1-receptor antagonist
specifications As per innovator Specifications
The status in reference
regulatory authorities Vesomni Tablet 6.0/0.4mg approved by EMA

For generic drugs (me-too
status) Tamsolin-S Tablet 6.0/0.4mg by Getz Pharma (Pvt) Ltd.
GMP status of the Finished Last inspection report dated 18.06.2020 concluded good level of
product manufacturer cGMP compliance.
Name and address of API Solifenacin Succinate:

manufacturer. M/s Optimus Drugs (Pvt.) Limited.
Survey No. 239 & 240, Dothigudan (V), Pochampally (M),
Yadadri, BhuvanagriIndia Tamsulosin HCl:
M/s Symed Labs (Pvt) Ltd.
Survey No, 353, Domadugu (Village),
Jinnaram
(Mandal),Medak (Dist) ,Telangana, INDIA.
Module-II (Quality Firm has submitted QOS as per WHO QOS-PD template.
Overall Summary) Summarized information related to structure, general properties,
Manufacturers, description of manufacturing process and controls,
Characterization, Impurities, Specifications, Analytical procedures,
Validation of analytical procedure, batch analysis and justification
of specification, reference standard, container closure system and
stability studies of drug substance and drug product is submitted.
Module III (Drug Substance) The firm as submitted detail of General information, General
properties, Manufacturers, description of manufacturing process and
process controls,
Characterization, Impurities, Control of drug substance, Reference
standard or materials container closure system and stability studies
of drug substance.
Stability studies Solifenacin Succinate
Batch No Accelerated Long Tamsulosin HCl

Term Stability study
OP-SSC-S7-001- 6 Months 48 Months conditions:
17 Real time: 30°C ±
OP-SSC-S7-002- 6 Months 48 Months 2°C / 65% ±
17 5%RH for 60
OP-SSC-S7-003- 6 Months 48 Months months
17 Accelerated: 40°C
°
± 2 C / 75% ± 5%RH for 6 months
Batch No Accelerated Long Term
XYZ 0010114 6 Months 60 Months

Module-III (Drug Product): The firm has submitted detail of Drug Products including
Description and composition of drug product, Pharmaceutical
Development, Manufacturing process development,
Microbiological attribution, Manufacturer, Master formulations,
Description of Manufacturing Process and Process Controls,
Control of Critical Steps and Intermediates, Process Validation and/
or Evaluation, Control of Excipients with specification and
Analytical methods, Control of Drug Products including Finished
product specifications and test methods, validation of

Analytical methods, Batch analysis , Characterization of
impurities, reference standard or impurities, Container
closure and stabilities studies.
Pharmaceutical equivalence Pharmaceutical Equivalence have been established against
and comparative dissolution the brand leader that is Tamsolin-S 6.0/0.4mg Tablet by
profile Getz Pharma by performing quality tests
(Identification, Assay, Dissolution) CDP has been
performed against the same brand that is Tamsolin-S
6.0/0.4mg Tablet by Getz Pharma in Acid media (pH 1.2)
, Acetate Buffer (pH 4.5) & Phosphate Buffer (pH 6.8)
validation/verification of Introduction, Verification of assay method, Specificity,
product Accuracy, Precision, Linearity concentration and peak
range.
Manufacturer of API Solifenacin Succinate:
M/s Optimus Drugs (Pvt.) Limited.
Survey No. 239 & 240, Dothigudan (V), Pochampally (M),
Yadadri, BhuvanagriIndia
Tamsulosin HCl:
M/s Symed Labs (Pvt) Ltd.
Survey No, 353, Domadugu
(Village), Jinnaram
(Mandal),Medak (Dist) ,Telangana, INDIA.
API Lot No. Solifenacin Succinate
OP-SCC/10/19/003
Tamsulosin HCl 6TSN0010519
Description of Pack Alu-Alu. Blisters with aluminum foil having leaflet and
(Container closure system) packed in unit carton
Real Time: 0, 3, 6, 8, 12, 16, 20, 24(Months)
Batch No. ST/001 ST/002 ST/003

No. of Batches 03
1. Reference of previous Firm has referred to onsite inspection report of their product:
approval of applications
with stability study data of EMPAZON 10mg Tablets, EMPAZON 25mg Tablets
the firm (if any) (Empagliflozin) which was conducted on 1st June, 2021 and
was presented in 307th meeting of Registration Board held on
08-10th June , 2021.
EMPAZON 10mg Tablets, EMPAZON 25mg Tablets
(Empagliflozin) by M/s. Horizon Healthcare (Pvt) Ltd. Lahore.
Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on
accelerated studies for six months.
Following two observations were reported in the report: i.
ii.Audit trail on the testing reports of EMPAZON 10mg
and 25mg Tablets, Dayzol 30mg and 60mg Capsules is
available.
iii. Adequate monitoring and control are available
for stability chamber. Chamber are controlled and
alerts as well.
2. Approval of API/ Solifenacin Succinate:

DML/GMP certificate of Firm had provided valid GMP and DML Certificate of M/s
API manufacturer issued by Optimus Drugs (Pvt.) Limited. Issued by Drugs Control
concerned regulatory Administration Government of Telangana,
authority of country of GMP Valid upto 24-05-2022 DML Valid upto: 09-09-2023
origin. Tamsulosin HCl:
Firm had provided valid GMP and DML Certificate of M/s
Symed Labs (Pvt.) Limited. Issued by Drugs Control
Administration Government of Telangana,
GMP Valid upto 03-03-2022
3. Documents for the Copy of commercial invoice attested by AD I&E DRAP,
procurement of API with Lahore, has been submitted.
approval from DRAP (in Solifenacin Succinate:
case of import).

Imported approval
by DRAP
OP- 1920OD267/EXP 07kgs 13-01-
SSC/10/19/003 2020
Copy of commercial invoice attested by AD I&E DRAP,

Lahore, has been submitted.
Tamsulosin HCl:

Imported approval
by
DRAP
6TSN0010519 Symed- 0.020kgs 23-04-
201921-20 2020
4. Data of stability batches Submitted

will be supported by
attested respective
documents like
chromatograms, Raw data
sheets, COA, summary data
sheets etc.
5. Compliance Record of Audit trail reports have been submitted.
HPLC software 21CFR &
audit trail reports on
product testing
6. Record of Digital data Firm has submitted record of Digital data logger for
logger for temperature and temperature and humidity monitoring of stability chambers.
humidity monitoring of
stability chambers (real

3.2.S.4.4 Details of site address of the Firm has corrected site address in
drug substance manufacturer section 3.2.S.2.1 according to
mentioned on COA of drug COA
substance are different form
that mentioned in section
3.2.S.2.1
3.2.P.3.2 Composition of each layer of Firm has submitted batch formula
Solifenacin succinate and where in composition for
Tamsulocin HCl shall be Solifenacin immediate release
described separately in batch layer and Tamsulocin HCl
formula. extended release layer have been
mentioned separately.
3.2.P.5.2 Justification shall be submitted Justification shall be submitted for
for applying 100rpm with USP applying 100rpm with USP Paddle
paddle apparatus , in the test of apparatus in the test of dissolution
Dissolution of Tamsulocin of Tamsulosin HCL in the light of
HCl in the light of USP USP general chapter<1092> As
general chapter <1092> per The united states

pharmacopeia, The general
Information chapters <1092> The
dissolution Procedures:
Development and Validation,
Under the Sub section 2.3
Agitation of section 2.0 Method
Development “If justified, 100 rpm
may be used with Apparatus2,
especially for Modified-release
products”. The tamsulosin is
Modified release in our product,
hence we used the 100 rpm with
comparing the Tamsulosin
Modified release capsule official
Monograph in USP.
3.2.P.5.6 Justification shall be submitted The Dissolution Parameters and
for selection of dissolution Limits of Solifenacin (Immediate
parameters and limits for the Release) was taken from FDA
test of Dissolution of both Dissolution method guidelines
drug substances. While the Tamsolusin Parameters
and Limits was taken from
Tamsulosin Modified release
capsule official Monograph in
USP. Also the time points
Parameters was chosen from
concerning the USP <1092> The
dissolution Procedures:
Development and Validation For
testing an Modified-release dosage
form, at least three time points are
chosen, to guard against dose
dumping, to define the in vitro
release profile, and to show that
essentially complete release
(>80%) of the drug is achieved.
Additional sampling times may be
useful. Selection of the final time
points is reflective of the data from
the drug release profile that are
generated during development. For
products containing more than a
single active ingredient, determine
the drug release for each active
ingredient. The Comparative
dissolution profile for the both
drug substances in Combination
product also clarify our parameters
and Limits.
3.2.P.8.3 • Valid GMP certificate or • Firm has submitted copy of

Drug Manufacturing GMP certificate issued by
License shall be submitted DCA Goverrnment of
of the relevant unit of Telangana, in the name of M/s
Symed labs, from which Symed Labs, Unit VI valid
upto 14-09-2022.

Tamsulocin HCl has been • Firm has submitted copy of
imported. commercial invoice dated 18-
05-2020 for the procurement of
• Evidence of availability of Tablet press machine ZP-31
bi-layer compression along with bill of lading.
machine shall be
submitted.

448. Name, address of Applicant / M/s Wimits Pharmaceuticals (Pvt) Ltd.
Name, address of Manufacturing site. M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot
#129 Sundar Industrial Estate,Raiwind
road,Lahore
☐ Importer
giver)
☐ Export sale
Ebatrix 5mg/5ml syrup
name
Active Pharmaceutical ingredient (API) Ebastine ----------- 5mg
per unit
Pharmaceutical form of applied drug Almost colourless, clear solution with
characteristics odour of anise.
Pharmacotherapeutic Group of (API) Histamine H₁-receptor antagonist, Anti allergic
agent
In - house
specifications
Proposed Pack size 1×30ml
USFDA Approved.
authorities
For generic drugs (me-too status) Kestine 5mg/5ml oral liquid by M/s Highnoon
Labortories Ltd, Reg. No. 028369

manufacturer Tablet,oral liquid (General) section approved.
Name and address of API manufacturer. M/s Vasudha Pharma Chem Limited,
Unit-I, Plot No. 37/A, 38, 39, A & B,Phase-I,
IDA, Jeedimetla,Hyderabad – 500 055,
Telangana, INDIA.
submitted.
Module III (Drug Substance) Official monograph of Ebastine is present in
BP. The firm as submitted detail of
months
months
Batches: (TEK-001/2021, TEK-002/2021,
TEK-003/2021)
product.
comparative dissolution profile established against the brand name is Kestine
5mg/5ml oral liquid by M/s Highnoon
Labortories Ltd. by performing quality tests
(Identification, Assay)
of product including linearity, range, accuracy, precision,
specificty.

Manufacturer of API M/s Vasudha Pharma Chem Limited,
Unit-I, Plot No. 37/A, 38, 39, A & B,Phase-I, IDA,
Jeedimetla,Hyderabad – 500 055,Telangana, INDIA.
API Lot No. B# EB/2006004
Description of Pack Solution is filled in amber glass bottle(1×30ml) that is packed in
(Container closure system) unit carton alongwuth leaflet insert.
Batch No. TEK001 TEK002 TEK003
Batch Size 166 packs 166 packs 166 packs
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP certificate No. 22/03/19 issued
of API manufacturer issued by concerned by FDCA valid till 21/03/2022.
3. Documents for the procurement of API • Copy of commercial invoice no.

with approval from DRAP (in case of 0370/U1/E/20-21 attested by AD DRAP I&E
import). Lahore dated 22-01-2021 for the import of
5Kg of Ebastine.
sheets etc.
testing
6. Record of Digital data logger for Firm has submitted record of Digital data
stability chambers (real time and monitoring of stability chambers.
accelerated)
1.6.5 Valid GMP certificate of the drug Firm has submitted copy of GMP
substance manufacturer shall be certificate no. 73252/TS/2022 issued by
submitted. Drug Control Administration
Telangana, valid upto 03-2025.

3.2.P.2.2.1 Justification shall be submitted for Innovator product was not registered in
not performing Pharmaceutical Pakistan so we performed the
equivalence studies against the pharmaceutical equivalence with local
innovator product brand & attached
3.2.P.2.5 Preservative efficacy studies shall Firm has submitted microbial testing
be submitted. report for preservative effectiveness
testing.
3.2.P.5.1 Justification/Reference shall be Firm has referred to the results of pH
submitted for the limits of pH test. test of Innovator product.
3.2.P.5.2 Details of the test of Uniformity of Firm has submitted analytical record
Dosage unit shall be submitted. for the performance of Uniformity of
dosage unit by way of Assay.
3.2.P.8.3 Justification shall be submitted for Firm has submitted microbial testing
not performing preservative report for preservative effectiveness
efficacy studies during stability testing.
studies. Firm has submitted copy of letter
Documents confirming import of No.1279/2021-DRAP-AD-CD(I&E)
drug substance shall be submitted. dated 22/01/2021 is submitted wherein
Analytical record i.e., Raw data the permission to import different APIs
sheets, Chromatograms shall be including EBASTINE for the purpose
submitted for each time point of of test/analysis and stability studies is
both accelerated and long term granted.
stability studies of three batches. Firm has submitted analytical record for
complete stability studies for both
accelerated and long term conditions.

b. Deferred cases
449. Name, address of Applicant / M/s Novamed Pharmaceuticals(Pvt.)Ltd
28-KM Ferozepur Road, Lahore- Pakistan
Name, address of Manufacturing site. M/s Novamed Pharmaceuticals(Pvt.)Ltd
Lahore
28-KM Ferozepur Road, Lahore- Pakistan
☐ Importer
giver)
Status of application ☒New Drug Product (NDP)
☐ Export sale

Kefie Injection 1gm/5ml
name
Active Pharmaceutical ingredient Levocarnitine ………….………1gm
(API) per unit
Pharmaceutical form of applied drug Clear colorless liquid free from foreign
particles
Intravenous injection
Pharmacotherapeutic Group of (API) Amino Acid Derivative, belongs to the class of
organic compounds known as carnitines.
USP
specifications
Proposed Pack size 1’s (5ml)
The status in reference regulatory Carnitor Injection 1gm/5ml, approved in FDA
authorities USA
GMP status of the Finished product Certificate of cGMP Dated:11-01-2019 on the
manufacturer basis of inspection conducted on 08-01-2019
Name and address of API manufacturer. Northeast Pharmaceutical Group Co., Ltd
No.29 Shenxiliu Dong Road, Economic
Technology Development District, Shenyang,
P.R.China
submitted.
Module III (Drug Substance) Official monograph of Levocarnitine is present
months

months
Batches: (01714080001, 01714080002,
01714080003)
Carnitor 1gm/5ml Injection Novamed
Pharmaceuticals by performing quality tests
(Identification, Assay, , pH).
CDP has not been Applicable.
specificity.
Manufacturer of API Northeast Pharmaceutical Group Co., Ltd
P.R.China
API Lot No. DY0171900142
Description of Pack Individual vial is placed in a PVC Tray which
(Container closure system) is blistered from its open end with printed
aluminum foil. Each Blistered tray containing
one clear vial of 5ml is packed in Specific Unit
carton along with a patient information leaflet
Batch No. TP-
160- TP-160-T3 TP-160-T4
T2
Batch Size 500 500 vials 500 vials
vials
2020
05- 20-05-2020 20-05-2020
2020
No. of Batches 03

firm (if any)
2. Approval of API/ DML/GMP certificate Copy of Drug manufacturing license
of API manufacturer issued by concerned (License no. Liao 20150001) for M/s
regulatory authority of country of origin. Northeast Pharmaceutical Group Co., Ltd
P.R.China. issued by Liaoning Food and
Drug Administration of the People’s
Republic of China is submitted, valid upto
10-12-2025
3. Documents for the procurement of API • Copy of letter No.8830/2019/DRAP-AD-
with approval from DRAP (in case of CD(I&E) dated 25/06/2019 is submitted
import). wherein the permission to import different
APIs including Levocarnitine for the
purpose of test/analysis and stability
studies is granted.
• Commercial invoice No # HR 19079
dated:24-05-2019, DRAP Lahore Attested
dated: 28-06-2019 is also submitted.
Raw data sheets, COA, summary data summary data sheets
sheets etc.
drug product.
chambers.
1. 1.6.5 (B) Valid Good Manufacturing DML of API submitted.
Practice (GMP) certificate of the
Drug Substance manufacturer
authority of country of origin
2. 3.2.S.4 Differences from the officially All the required test has been
recognized compendial performed and revised COA is
standard(s) shall be justified, as attached.
claimed specifications are USP Drug substance manufacturer
but certain testes are not included and Drug product manufacturer
i.e Enantiomeric Purity, chloride claimed USP, API specification
and sulfate, limit of potassium, but both did not performed
limit of sodium Enantiomeric Purity. According
to USP NMT 0.2% of D-
carnitine is mentioned.

3. 3.2.S.5 COA of primary / secondary Certificate of analysis of primary
reference standard including reference standard attached.
provided.
4. 3.2.P.2.1.1 As per relevant guidelines & Owing to the prevailed condition
structure of Form 5F, of covid throughout the world We
Pharmaceutical equivalence shall had performed PE after
be established with the innovator / formulation development due to
reference / comparator product at unavailability of the Innovator
the time of formulation pack. So, as per the need of hour
development, while according to or to overcome this challenge we
your submitted data, deviated from the flow. However,
Pharmaceutical equivalence have we confirm that this deviation will
been performed 27-02-2021 not be repeated.
which is after commencing
stability studies.i.e 20-05-2020
Justification shall be submitted.
5. 3.2.P.5.3 • As per relevant guidelines & USP Method was adopted for the
structure of Form 5F testing of the finished product.
Analytical test method During testing at each point the
verification has to be recovery or accuracy was as per
performed at the time of predefined specification. Further
formulation development, system suitability was performed,
while according to your for which the RSD is in limit, in
submitted data, Analytical test other words we can say this
method verification have been method is repeatable. However,
performed on 16-03-2021 we confirm that this deviation will
while stability studies not be repeated.
started on 20-05-2020.
Justification shall be • Performed and Revised
submitted in this regard. copy Attached.
• Accuracy is not performed. • Revised copy is attached.
• Range is not calculated
• Justify the analytical method
of repeatability and
intermediate precision in
accordance with performance.
6. 3.2.P.8 Documents for the procurement Copy of DRAP attested invoice
of API with approval from DRAP and import permission letter is
attached.
th
Decision of 313 : Registration board deferred the case for following:
• Performance of Enantiomeric Purity test for Drug substance by drug product manufacturer.
• For confirmation of required manufacturing facility i.e filling of 5ml Vial.
Evaluation by PEC: The firm has submitted COA having Enantiomeric purity by fluorescence
detector test.
The firm has submitted a letter from CLB having Liquid injectable Ampoule/Vial general-Revised.
section
Decision: Approved.

• Registration letter will be issued upon submission of evidence of performance of
Enantiomeric purity test of drug substance by drug product manufacturer as recommended
by USP monograph.
450. Name, address of Applicant / Marketing M/s AGP Limited
Authorization Holder B-23-C, S.I.T.E., Karachi
Name, address of Manufacturing site. M/s AGP Limited
B-23-C, S.I.T.E., Karachi
☐ Importer
(contract giver)
Status of application ☐New Drug Product (NDP)
☒Generic Drug Product (GDP)
☐ Export sale
Dy. No. and date of submission Dy.No 20777 dated: 30th July 2021
Details of fee submitted PKR 30,000/-: dated: 24th May 2021
The proposed proprietary name / brand name Rigix Oral Solution (Strawberry
flavor)
Strength / concentration of drug of Active Each 5ml contains:
Pharmaceutical ingredient (API) per unit Cetirizine HCl………….5mg
Pharmaceutical form of applied drug Clear colorless liquid with
characteristic strawberry flavor and
odor.
Pharmacotherapeutic Group of (API) Antihistamine for systemic use
Reference to Finished product specifications BP Specification
Shelf life claimed is 24months.
Proposed Pack size 60ml and 120ml
Proposed unit price Rs. 78.09/- for 60ml
Rs. 124.17/- for 120ml
The status in reference regulatory authorities Cetirizine Hydrochloride 5mg/5ml by
Chain Drug Consortium LLC
(Premier Value), USA,
USFDA Approved.
For generic drugs (me-too status) Zyrtec 5mg/5ml Oral Solution by
M/s GlaxoSmithKline. Reg. No.
016937
GMP status of the Finished product Renewal of DML on 30th June2020.
manufacturer Firm has oral liquid (general) section.
Name and address of API manufacturer. Cetirizine Hydrochloride:
M/s PRAVEEN LABORATORIES
PVT. LTD, India,
Block No. 206, Village: Jolwa,
Taluka: Palsana Dist.: Surat, Gujarat,
INDIA.

QOS-PD template. Firm has
summarized information related to
analysis and justification of
Module III (Drug Substance) Official monograph of Cetirizine
Hydrochloride is present in BP. The
firm as submitted detail of
properties, Solubilities, physical form,
specifications, analytical procedures
Stability studies API Stability study conditions:
: 25°C ± 2°C / 60% ± 5%RH for 60
months
30°C ± 2°C / 65% ± 5%RH for 60
months
Accelerated: 40°C ± 2°C / 75% ±
5%RH for 6 months
procedure and its verification studies,
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence is carried
dissolution profile on with Zyrtec Oral Solution
manufactured by GSK pakistan
Analytical method validation/verification of Method verification studies have
product submitted including System
suitability, accuracy, precision,
specificity, Limit of detection, Limit
of quantification.

Manufacturer of API Cetirizine Hydrochloride:
M/s PRAVEEN LABORATORIES PVT.
LTD, India,
Block No. 206, Village: Jolwa, Taluka:
Palsana Dist.: Surat, Gujarat, INDIA.
API Lot No. Cetirizine Hydrochloride:
MK40119136, MK40119137, MK40119138 &
MK40119139
Description of Pack Amber glass bottle with ALU fitted with wad.
(Container closure system) Each bottle is packed in printed carton.
Intermediate: 30°C ± 2°C / 65% ± 5%RH
Intermediate: 6 months
Intermediate: 3, 6, 9, 12 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. TR-
TR-644 TR-645
643
Batch Size 4.0 L 4.0 L 4.0 L
2020
29-10-2020 29-10-2020
2020
No. of Batches 03
1. Reference of previous approval of The board approved Glyzia-XR Tablet
applications with stability study data of the 50/500m of M/s AGP limited B-23,
firm (if any) SITE, Karachi in 285th meting held in
October 2018.
As per minutes, HPLC is 21 CFR
compliant and have audit trails.
2. Approval of API/ DML/GMP certificate of Cetirizine Hydrochloride: Copy of
API manufacturer issued by concerned GMP certificate No. S-
regulatory authority of country of origin. GMP/21092927 issued by Food and
Drug Control Administration, India,
valid till 09th Oct 2023.
3. Documents for the procurement of API with ADC Attested Karachi invoice no
approval from DRAP (in case of import). Ex/060 date 1-1-2020
4. Data of stability batches will be supported by Data of 3 batches of 4 liter each with
attested respective documents like raw data sheets, COA, and
chromatograms, chromatograms have been submitted.
etc.

5. Compliance Record of HPLC software 21CFR Compliance Record of HPLC
& audit trail reports on product testing software 21CFR & audit trail reports
on product testing was submitted
and humidity monitoring of stability chambers
a) 2.3.P.8/ 3.2.P.8 Stability. The storage condition “Do The Rigix oral solution (Cherry
not store above 25C ” does not meet zone IV a flavour) is also a brand of innovator
condition. Please Justify. purchased by AGP few years back. The
storage temperature conditions of Rigix
oral solution (Cherry Flavour) is “Do
not store above 25℃. Therefore, we
have conducted the stability studies of
Rigix Oral solution (Strawberry
Flavour) at 30+- 2℃ / 65+-5% RH
(real time for 12 months at initial, 6, 9th
and 12month.) of 3 batches.
40+- 2℃ / 75+-5% RH (Accelerated
for 6months) of 3 batches.
The other brand of innovators “Zyrtec”
in USA has also the same storage
condition i.e. Between 20 ℃ to 25 ℃.
b) Approval of valid API/ DML/GMP certificate of We hereby revise the storage condition
API manufacturer issued by concerned regulatory as “Store below 30’C.” The firm did
authority of country of origin is required. not submit fee for correction.
The me-too product Zyrtec by GSK
Pakistan has storage condition “Do not
store above 30’C.
Valid copy of GMP certificate of API

manufacturer i.e. M/s PRAVEEN
LABORATORIES PVT. LTD, India,
Block No. 206, Village: Jolwa, Taluka:
Palsana Dist.: Surat, Gujarat, INDIA.
valid till 19-9-2023. Certificate is
issued b Food and Drug Control
Administration.
th
Decision of 316 : Deferred for justification of not performing long term stability studies testing at
3rd month time point.
Evaluation: The firm has submitted:
• We have conducted stability studies of our product on Zone IV-A (30°C ± 2°C / 65 ± 5%
RH) and by mistake we have skipped 3rd month stability testing point but we have performed
6th month, 9th month and 12th months stability studies and results shows that the product is
stable.
• We have also performed accelerated stability studies for 0, 3 & 6 months, the results are also
in compliance with specifications.

• We assure you that we will continue the stability studies up to the shelf life of 24 months i.e.
18th months, 24months and submit the data at DRAP.
Decision: Approved.
451. Name, address of Applicant / Marketing M/s Shazal’s Pharmaceuticals,
Authorization Holder 41/A-1, Phase-1, Industrial Estate
Hattar
Name, address of Manufacturing site. M/s Shazal’s Pharmaceuticals,
41/A-1, Phase-1, Industrial Estate
Hattar
☐ Importer
(contract giver)
☐ Export sale
The proposed proprietary name / brand name Zyacef 200mg/5ml suspension
Strength / concentration of drug of Active Each 5ml dry powder for suspension
Pharmaceutical ingredient (API) per unit contains:
Cefixime (as trihydrate)….200mg
Pharmaceutical form of applied drug Dry powder for suspension
The status in reference regulatory authorities Approved by MHRA
For generic drugs (me-too status) Cefiget 200mg / 5ml Suspension By
GETZ Aventis Pharma
GMP status of the Finished product 13-2-2019 and 19-1-2020. The panel
manufacturer unanimously recommends resumption
of production activites in all section
of the firms.
Name and address of API manufacturer. M/s. Pharmagen Ltd Kot nabi Bukhsh
wala, 34km ferozpur road Lahore.
QOS-PD template. Firm has
summarized information related to

manufacturers, Characterization,
specifications, analytical procedures
and its validation, batch analysis and
stability studies of drug substance. The
firm has summarized information of
drug product including its description,
composition, pharmaceutical
justification of specifications,
reference standard or materials,
Module-III (Drug Product): Firm has submitted relevant
information against the Module III,
including, Process validation
protocol, Finished product analytical
method validation report & stability
studies data.
Manufacturer of API M/s. Pharmagen Ltd Kot nabi Kuksh
wala, 34km ferozpur road Lahore.
API Lot No. 00244/043-2019
Description of Pack
Amber glass bottle
Stability Storage Condition Real time : 30°C ± 2°C / 65% ±
5%RH
Accelerated: 40°C ± 2°C / 75% ±
5%RH
Frequency Accelerated: 0,3, 6 (Months)
Real Time: 0, 3, 6, 9 (Months)
Batch No. Cef-T1 Cef-T2 Cef-T3
Batch Size 16kg 16kg. 16kg
No. of Batches 03
1. Reference of previous approval of • N/A
firm (if any)

2. Approval of API/ DML/GMP certificate of GMP certificate was issued to M/s
API manufacturer issued by concerned Pharmagen Ltd based on evaluation
regulatory authority of country of origin. conducted on 8-1-2019.
3. Documents for the procurement of API with API source is local. Local Invoice is
approval from DRAP (in case of import). attached.
4. Data of stability batches will be supported by Firm has submitted record of testing
attested respective documents like of all batches along with
Raw data sheets, COA, summary data sheets and summary data sheets
etc.
testing
6. Record of Digital data logger for temperature Firm has submitted record of data
and humidity monitoring of stability logger for temperature and humidity
chambers (real monitoring of real time and
time and accelerated) (VI) accelerated stability chambers
Observation Response
Submit data of pharmaceutical equivalence in Firm has performed comparative analysis of
section 3.2.P.2.2.1. to comply the decision of their
293rd meeting of Registration Board, which developed formulation against the comparator
states that “Pharmaceutical equivalence of the product i.e. “Cefiget”. Firm has
applied drug shall be established with the submitted results of pharmaceutical equivalence
innovator / reference / comparator product and for all the quality tests for their product against
results the
of all the quality tests (mentioned in any official comparator product.
pharmacopoeia or section 3.2.P.5.1 of this . The results depicts that the developed
application) formulation is
of the developed formulation and the innovator / comparable to the comparator product.
reference / comparator product should be
submitted and discussed”.
Submit the data of verification of analytical Firm has submitted protocols and results of
method for drug substances in section 3.2.S.4.3 verification of analytical method of drug
to comply the decision of 293rd meeting of substance
Registration Board, which states that “Analytical based on recommendations of USP.
Method Verification studies including
specificity, accuracy and repeatability (method
precision) performed by the Drug Product
manufacturer for both compendial as well as
noncompendial drug substance(s) shall be
submitted”.
Decision of 308th : Deferred for following:
Submission of details of stability chambers for conducting stability studies.
Batch size in units.
Pharmaceutical equivalence with innovator’s product
Evaluation VI:

a) Submission of details of stability Details of stability chambers both long term of 400L
chambers. and accelerated chambers of 500L of Organa
international have been submitted.
b) Batch size in units Batch Size is of 5000 bottles
c) Pharmaceutical equivalence with Pharmaceutical equivalence has been done with Cefiget
innovator product 200mg/5ml of Getz Pharma having batch number 954.
Decision: Approved.
• Registration letter will be issued upon submission of Pharmaceutical equivalence studies
against the innovator product i.e, Cefspan suspension.
Case no 4: Registration of applications for

Exemption from onsite verification of stability data
Deferred case
452. Name and address of manufacturer "M/s Macter International Limited F-216, S.I.T.E.,
/ Applicant Karachi-Pakistan.
Brand Name +Dosage Form + Indamac 85mcg +43mcg DPI Capsule
Strength
Composition Each DPI Capsule Contains:
Indacaterol maleate eq to Indacterol……85mcg
Glycopyrronium bromide eq to glycopyrronium …. 43 mcg
Diary No. Date of R& I & fee Dy. No: 9787 : date 24-07-17: Rs. 50,000 7-7-2017Slip No:
0313258
Pharmacological Group Bronchodilator
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 10’s, 20’s, 30’s /As per SRO
Approval status of product in Approved in EMA
Reference Regulatory Authorities Ultibro Breezhaler
Me-too status Ultibro Breezhaler of Novartis Pharma
GMP status The firm was granted GMP certificate based on inspection
Drug Indamac 85mcg +43mcg DPI Capsule
Name of Manufacturer M/s Macter International Limited F-216, S.I.T.E., Karachi-Pakistan.
Manufacturer of API Glycopyrrolate U.S.P: M/s. Harman Finochem Ltd.
Indacaterol maleate: Inke S.A Area Industrial Del Llobregat
API Lot No. Glycopyrrolate U.S.P: GCP/004/2017-2018/A
Indacaterol: PP-1 PR3
Description of Pack
Alu-Alu blister
Stability Storage Condition Real Time: 30oC ± 2oC / 65% ± 5%RH
Accelerated:40oC ±2oC / 75% ± 5%RH

Time Period Real Time: 24 Months
Accelerated:06Months
Frequency Real Time: 0,1,3,6,9,12,18,24 Months(on going)
Accelerated: 0,1,3,6 Months
Batch No. 001P 002P 003P
No. of Batches 03
Date of Submission 22/02/2019 Dy. No. 7826)
The firm has submitted stability study data as per checklist of 14 points approved by Registration Board in its
293rd meeting.
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last products “Venticort Rotacaps 100mcg+6mcg, which
two years. were presented in 257th meeting of Registration
board. Registration Board decided to approve
registration of Venticort Rotacaps 100mcg+6mcg of
M/s Macter International Limited F-216, S.I.T.E.,
Karachi-Pakistan.
According to the report generated following points
were confirmed
a) The HPLC used for analysis of stability batches is
Shimadzu 20 ATVP with auto sampler and gradient
system and it was 21 CFR compliant.
b) The firm has six stability chambers for real time and
accelerated stability studies which are equipped with
proper alarm system and data loggers
2. Certificate of Analysis of API from both API The firm has submitted copies of COA of drug substance
Manufacturer and Finished Product from drug substance manufacturer and analytical report
manufacturer. of their testing of raw material. Glycopyrrolate U.S.P of
M/s. Harman Finochem Ltd, Batch No. GCP/004/2017-
2018/A and Indacaterol of Inke S.A, Batch No. PP-1
PR3
3. Method used for analysis of API from both Analytical method for testing of API as well as from API
API Manufacturer and Finished Product manufacturer was submitted
manufacturer.
4. Stability study data of API from API The firm has submitted 6 months accelerated and 36
manufacturer. months real time stability study data of API as per zone
IVA.
5. Approval of API/ DML/GMP certificate of Copy of GMP certificate for Glycopyrrolate
API manufacturer issued by regulatory (Certificate#6087313) issued by Food and Drug
authority of country of origin. Administration, Aurangabad division, Maharashtra
state valid upto 10-04-2020.
Copy of GMP certificate for Indacaterol (Certificate#
NCF-II/1740/001/CAT ) issued by Directorate
General Ministry of Health of Govt of Catalonia –
spain issued on 21-06-2017

6. Documents for the procurement of API with Copy of commercial invoices to import
approval from DRAP (in case of import). Glycopyrrolate (0.010 kg) and Indacaterol (10 gm)
attested by AD, I&E DRAP, Karachi has been
submitted.
Detailed as under:
Batch No. Invoice No. Date of
approval
by DRAP
GCP/004/2017-2018/A P/E9/129/2017-18 01-08-2017
PP-1 PR3 Macter10102017 06-10-2017
7. Protocols followed for conduction of stability The firm has submitted protocols for conduction of
study stability studies.
8. Method used for analysis of FPP. Details of methods used for analysis of finished Product
“Indamac 85mcg +43mcg DPI Capsule ” has submitted
9. Drug-excipients compatibility studies (where
Excipients are same as of innovators product.
applicable)
10. Complete batch manufacturing record of Photocopies of complete batch Manufacturing records of
three stability batches. following 03 Batches:
Batch No. Batch Size Mfg. Date
10000 02-2018
001P
Capsules
10000 02-2018
002P
Capsules
10000 02-2018
003P
Capsules
11. Record of comparative dissolution data
N/A
(where applicable)
12. Data of 03 batches will be supported by
The firm has submitted stability study data of 03 batches
along with chromatograms, raw data sheets, COA, and
summary data sheet.
13. Compliance Record of HPLC software The HPLC software is 21CFR compliant
21CFR & audit trail reports on product Registration Board in its 257th decided to approve
testing. registration of Venticort Rotacaps 100mcg+6mcg of
M/s Macter International Limited Karachi.
According to the report generated following points
were confirmed
a) The HPLC used for analysis of stability batches is
Shimadzu 20 AT with auto sampler and gradient
system and it was 21 CFR compliant.
The firm has also submitted audit trail reports of applied
product.
14. Record of Digital data logger for temperature The record of Digital data logger for temperature and
and humidity monitoring of stability humidity monitoring of stability chambers is submitted
chambers (real time and accelerated) in soft copy as well as in hard copy
• The firm has submitted 06 months Accelerated and 24 months Real Time Stability Data for 03 Batches.
Deferred for confirmation of manufacturing facility for DPIs.
Evaluation by PEC:
Firm has submitted following documents:

• The Central Licensing Board in its 277th meeting held on 15th -16th October 2020, has considered and approved
the regularization of building layout in the name of M/s Macter International on the recommendation of panel
of experts for the following sections:
Sr no. Section
1 Capsule (General)
2 Capsule DPI (General)
Firm has submitted that we have our product DPI Capsule pilot batches were manufactured on 19-2-2018 in
available area of DPI, at that time there is no steroidal and non-steroidal separate section policy available. Later
CLB in its 277th meeting October 2020 has approved Capsule DPI General Section.
Firm has submitted following documents as per the decision of 290th meeting of Registration Board
regarding Manufacturing Requirements for Rotacaps (Dry Powder Inhaler).
• Evidence of approval of applied formulation in EMA. The label claim of EMA approved product
Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules is as follows:
Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of
indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of
indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of
glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium.
• Firm has submitted results of aerodynamic particle size distribution by cascade impactors for
Indamac DPI, uniformity of delivered dose, results of delivered dose contents of both indacaterol as well as
glycopyrronium

• Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product specifications,
• Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted in the
registration application.
• Manufacturer will perform process validation of first three batches as per the commitment submitted
in the registration application.
• Registration letter will be issued upon submission of Pharmaceutical equivalence studies including
test of “Aerodynamic particle size distribution test” & “Uniformity of delivered dose test” against
the innovator/reference product.
Agenda of Evaluator PEC-VII
Case no. 01 Registration applications for local manufacturing of (Human) drugs
a. New cases on Form 5
453. Name and address of manufacturer / M/s Medicon Pharmaceuticals Pvt Ltd.
Applicant

Industrial Estate, Jamrud Road, Peshawar,
Pakistan
Brand Name +Dosage Form + Strength Clonamed 2mg Tablet
Diary No. Date of R& I & fee Form-5 Dy.No 38246 dated 20-11-2018
Rs.20,000/- Dated 20-11-2018 (Slip#
0749866)
Clonazepam…2mg
Pharmacological Group Benzodiazepine derivatives
Form Form-5
Pack size & Demanded Price 3x10’s As per SRO
Approval status of product in KLONOPIN TABLETS (clonazepam) of
Reference Regulatory Authorities Roche Pharma (USFDA)
Me-too status Clonazep 2 mg Tabletsof Roryan Pharma
(Reg. 078589)
GMP status NA
Remarks of the Evaluator. GMP inspection report conducted on 14-12-
2020 is also provided wherein it is
concluded that the firm is considered to be
operating at satisfactory level of compliance
with cGMP guidelines as per Drug Act,
1976 and rules framed there under
Decision: Deferred for confirmation of requisite manufacturing facility i.e Tablet
Psychotropic Section.
454. Name and address of manufacturer / M/s. Obsons Pharma, industrial state, Kot
Applicant Lakhpat, Lahore
Brand Name +Dosage Form + Strength Tagalin capsules
Composition Each capsule contains:-
Pregabalin……..150 mg
Diary No. Date of R& I & fee Dy. No.2260; 23-01-2017; Rs. 20,000/-
Pharmacological Group Antiepileptic
Type of Form Form-5
Finished product Specifications Innovators
Pack size & Demanded Price 2x7’s
As per SRO
Approval status of product in Lyrica by Pfizer Prism CV (USFDA)
Me-too status Gabica by Getz Pharma
GMP status Latest GMP inspection report dated 22-02-
2022 concluded as satisfactory in tablet
general
Capsule general. Oral liquid and dry
powdered suspension section
Remarks of Evaluator
Decision: Approved with innovator’s specification. Firm shall submit the fee of Rs.
7,500 for correction/pre-approval change/ in product specifications, as per
notification No.F.7-11/2012- B&A/DRAP dated 07-05-2021.
b. Deferred cases on Form 5

455. Name and address of manufacturer / M/S Welwrd Pharmaceuticals, Plot No ; 3,
Applicant Block A, Phase I– II, Industrial Estat,
Hattar, Pakistan
Contract manufacturing from M/s
WinBrains Research Laboratories, Plot #
69/1, Phase I-II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Top-Dex eye drops
Diary No. Date of R& I & fee Form-5 Dy.No 26337 dated 28-12-2017 Rs.
50,000 Dated 28-12-2017
Composition Each Drop Tainer Dispenser Contains:
Dexamethasone………… 0.1%
Tobramycin ………………0.3%
Pharmacological Group Corticosteroids and Aminoglycoside
antibiotic
Type of Form Form-5
Finished Product Specification Innovator
Pack Size & Demanded Price 5ml
As per SRO
Approval Status of Product in TOBRADEX by Novartis (USFDA
Reference Regulatory Authorities. Approved)
Me-too Status TOBRADEX by Novartis
GMP status M/S Winsbrain GMP Certificate of GMP,
Date: 20-5-2019(Have eye drop general
section)
Remarks of the Evaluator. Sections of welward: 8
Products on contract manufacturing: 4
(2 approved letter awaited)
Clarification shall be submitted whether
applied formulation is
in solution form or suspension form, since
reference product
approved by USFDA is in suspension
dosage form.
Confirmation of container closure system
whether as per
innovator or otherwise and confirmation of
manufacturing facility of Drop Tainer
Dispenser
Decision 293:
Deferred for clarification of dosage form i.e. solution or suspension
Remarks of evaluator
Firm revised the formulation with 20,000 fees (#2028796) dated 06/07/2020 to
Each ml suspension Contains:
Dexamethasone………… 0.1%
Tobramycin ………………0.3%
Decision of 296:
Deferred for confirmation of separate dispensing booth for steroidal ingredients
Firm submitted that our inspection is conducted but no inspection report is provided
Decision: Approved with innovator’s specification. Registration letter will be
issued after submission of GMP inspection report from QA&LT Division, showing
evidence of separate dispensing booth

456. Name and address of manufacturer / M/s. Winthrox Laboratories Plot # K-219-
Applicant A, SITE, Super Highway Phase II, Karachi
Brand Name +Dosage Form + Strength Womic-D Tablet 830mg+400IU
Diary No. Date of R& I & fee Diary No: 521 , 17/11/2016 , Rs. 20,000/-
Composition Each Tablet contains:
Ossein MineralComplex…830mg
Vitamin D………………..400 I.U
Pharmacological Group Mineral + Vitamin
Type of Form Form-5
Finished Product Specification Mfg.
Pack size & Demanded Price As per SRO / Pack size as per SRO
Approval status of product in Wellese Calcium and Vitamin D3 Tablet by
Reference Regulatory Authorities. Botanical Laboratories, USA.
Me-too status Bonmin Tablet by M/s. S J & G Fazal Elahi,
Karachi.
GMP status 09-10-2018 Routine GMP Inspection
“overall GMP compliance level is rated as
good.”
Remarks of Evaluator Evidence of international availability
provided by firm could not be confirmed in
reference regulatory authority.
Previous Decision (M275) Registration Board in its 275th meeting
decided as under:
Deferred for submission of following:
Evidence of approval in reference
regulatory authorities.
Evidence of availability of atomic
absorption spectrophotometer
Remarks of Evaluator XIII Firm provide the evidence of Me-Too
product Bonmin Tablet Registered in the
name of M/s. S J & G Fazal Elahi Pvt Ltd,
Karachi. (Reg. No. 070532)
Evidence of availability of atomic
absorption spectrophotometer is required.
Previous Decision (M295) Deferred for confirmation of availability of
Atomic absorption spectrophotometer
Remarks of Evaluator VII Firm provide the evidence of availability of
atomic absorption spectrophotometer. In
manufacturing license inspection report of
winthrox Lab dated 1-01-2015 atomic
absorption is verified by Federal inspector
of drug in the list of equipment’s.
Previous Decision (M312) Deferred for submission of complete
composition of Ossein mineral complex and
confirmation of avaialability of atomic
absorption spectrophotometer for analysis
of minerals.
Remarks of Evaluator VII Firm provide the evidence of availability of
atomic absorption spectrophotometer. In
GMP inspection report of winthrox Lab
dated 31-01-2022 atomic absorption is
verified by Federal inspector of drug in the
list of equipment’s.

Complete composition is provided as
Each film coating tablet contains
Vitamin D………400IU
Ossien Mineral complex…..830mg
Corresponding to
Calcium……………………177.6mg
Phosphorous……………….82.2mg
Residual Mineral Salt……24.9mg
Collagen………………….224mg
Other proteins…………....66.4mg Trace
elements F, Mg, Fe, Zn, Cu, Ni.
Corresponding to approximately 440mg
hydroxyapatite
Decision: Approved with innovator’s specification Firm shall submit the fee of Rs.
457. Name and address of manufacturer / M/s Lisko Pakistan Pvt Ltd. L-10-D, Block
Applicant 21, Shaheed Rashid Minhas Road, F.B.
Industrial Area, Karachi
Brand Name +Dosage Form + Strength Slim 120mg Capsule
Diary No. Date of R& I & fee Form-5 Dy.No 3588 dated 29-01-2018 Rs.
20,000 Dated 17-01-2018
Orlistat IR pellets 50% equivalent to
Orlistat……120mg
Source of pellets: M/s Vision
Pharmaceuticals, Islamabad
Pharmacological Group Lipase Inhibitor
Type of Form Form-5
Finished Product Specification USP Specs
Pack Size & Demanded Price Proposed packs: 10's, 20's, 30's, 84's
Proposed price: 85 Rs. Per Capsule
Approval Status of Product in XENICAL 120mg Hard Gelatin Capsule,
Reference Regulatory Authorities. CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24 17489 Greifswald Germany
Me-too Status Orlifit by Getz (Reg# 058474)
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)”
Previous Decision (M287) Registration Board deferred the case for
submission of accelerated stability study
data
of pellets by M/s Vision Pharmaceuticals,
Islamabad
Remarks of Evaluator VII While quoting the decision of 296th
meeting of Registration Board, firm has

referred to previously submitted real time
stability studies data of orlistat pellets from
M/s Vision
Pharmaceuticals.
Previous Decision (M307) Deferred for submission of source of pellets
in which stability studies of the pellets
have been conducted at real time conditions
i.e., 30°C ± 2°C/65% RH ± 5% RH
alongwith
quantification of degradation products
throughout the stability studies / assigned
shelf
life.
Remarks of Evaluator VII submission of stability study data
of pellets by M/s Vision Pharmaceuticals,
Islamabad
Decision: Deferred for further deliberation upon stability data requirement for
orlistat
Pellets in which stability studies of the pellets have been conducted at real time
conditions i.e., 30°C ± 2°C/65% RH ± 5% RH along with quantification of
degradation products throughout the stability studies / assigned shelf life.
458. Name and address of manufacturer / M/s Athan Pharmaceuticals.

Applicant Plot 84/1, Block B, Phase 5, Industrial
Estate, Hattar, Kpk, Pakistan
Brand Name +Dosage Form + Strength Aultolax 4mg Injection
Composition Each 2 ml Injection Contains:
Thiocolchicoside…4mg
Diary No. Date of R& I & fee Form-5 Dy. No 16521 dated 07-03-2019
Rs.20,000/- Dated 07-03-2019 (#1900766)
Pharmacological Group Muscle relaxants, centrally acting agents
Form Form-5
Pack size & Demanded Price 2 ml glass ampoule
As per SRO
Approval status of product in THIOCOLCHICOSIDE PHARMY II 4
Reference Regulatory Authorities mg/2 ml, solution injectable ampule. ANSM
approved
Me-too status Myolax Injection. Reg. No. Reg. No. 69277
GMP status DML issued on 5th March, 2019.
Remarks of the Evaluator VII
Previous Decision (M296) Deferred for consideration on its turn
notification No.F.7-11/2012- B&A/DRAP dated 07-05-2021. Registration letter will
be issued after submission of GMP inspection report from QA&LT Division, valid
within last three years


Brand Name +Dosage Form + Strength Athancinol Injection
Composition Each 4ml Injection Contains:
Phloroglucinol Hydrated…40mg
Trimethylphloroglucinol….0.04mg
Rs.20,000/- Dated 07-03-2019 (#1902260)
Pharmacological Group Antispasmodic
Form Form-5
Approval status of product in Spasfon injection by M/s Teva Health
Reference Regulatory Authorities (ANSM) France Approved (4 ml glass
ampoule)
Me-too status Spasrid Injection of Barrett Hodgson
Pakistan (Pvt) Ltd (Reg.# 034744)
Remarks of Evaluator VII The firm revised there form 5 and method
of manufacturer from
Each 4ml Injection Contains:
Phloroglucinol Hydrated…40mg
To
Each 4ml Injection Contains:
Phloroglucinol dihydrated…40mg (eq to
31.12 mg anhydrous phloroglucinol)
which is according to the reference product
with fee of 5000/- (#2038551) dated
03/9/2020
Decision: Approved with innovator’s specification Firm shall submit the full fee
for correction/pre-approval change/ in product specifications, as per notification
No.F.7-11/2012- B&A/DRAP dated 07-05-2021. Registration letter will be issued
after submission of GMP inspection report from QA&LT Division, valid within
last three years

Brand Name +Dosage Form + Strength Suxamethonium 50mg Injection (100mg/2ml)
Composition Each ml Injection Contains:
Suxamethonium chloride …50mg (IV/IM)
Rs.20,000/- Dated 06-03-2019 (#1900797)
Pharmacological Group Neuromuscular blocker
Form Form-5
Pack size & Demanded Price 2 ml ampoule
As per SRO

Approval status of product in Suxamethonium chloride 100 mg/2 ml
Reference Regulatory Authorities injection 2m1, clear glass ampoules, glass
type I (MHRA approved)
Me-too status Suxal Injection 100mg/ 2ml of M/s Global
Pharma (Reg. # 026629)
Remarks of Evaluator VII
Decision: Approved. Registration letter will be issued after submission of GMP

inspection report from QA&LT Division, valid within last three years
Brand Name +Dosage Form + Strength Transalta 250mg/5ml Injection
Composition Each 5ml Injection Contains:
Tranexamic Acid…250mg
Rs.20,000/- Dated 07-03-2019 (#1902375)
Pharmacological Group Haemostatic/ Anti-Fibrinolytic
Form Form-5
Approval status of product in PMDA approved
Me-too status Dravix 250mg/5ml Injection of Getz
Pharma Karachi


Brand Name +Dosage Form + Strength Moxid 400mg Tablets
Moxifloxacin as Hcl…400mg
Rs.20,000/- Dated 07-03-2019 (#1902267)
Form Form-5
Pack size & Demanded Price 1x5’s As per SRO
Approval status of product in AVELOX (moxifloxacin as hydrochloride)
Reference Regulatory Authorities 400mg tablets, film-coated. USFDA
approved

Me-too status G-Mox 400 mg Tablets by M/s Reliance
Decision: Approved with USP specification Firm shall submit the fee of Rs. 7,500
last three years

Brand Name +Dosage Form + Strength Spas 40mg Tablets
Otilonium Bromide…40mg
Rs.20,000/- Dated 07-03-2019 (#1902374)
Pharmacological Group anticholinergic, quaternary ammonium
compounds
Form Form-5
Approval status of product in Spasmomen of Italy
Me-too status Spasmomen tablet 40mg of Pharmatech.

Brand Name +Dosage Form + Strength Levo 250mg Tablets
Levofloxacin as hemihydrate…250mg
Rs.20,000/- Dated 06-03-2019 (#1900773)
Pharmacological Group Fluoroquinolones, Antibiotic
Form Form-5
Pack size & Demanded Price 10’s As per SRO

Approval status of product in Levofloxacin Tablets 250mg By Actavis
Reference Regulatory Authorities Group United Kingdom (MHRA)
Me-too status Leflox Tablets 250mg By Getz


Brand Name +Dosage Form + Strength Tazo 2mg Tablets
Tizanidine HCL Eq. to…2mg
Rs.20,000/- Dated 06-03-2019 (#1902355)
Pharmacological Group Muscle relaxant
Form Form-5
Approval status of product in Tizanidine 2mg Tablets by M/s Actavis UK
Reference Regulatory Authorities Ltd (MHRA)
Me-too status Musidin 2mg Tablet by M/s Martin Dow
(Reg# 027218)


Brand Name +Dosage Form + Strength Tazo 4mg Tablets
Tizanidine HCL Eq. to…4mg
Rs.20,000/- Dated 07-03-2019 (#1902373)
Pharmacological Group Muscle relexant
Form Form-5
Pack size & Demanded Price 10’s
As per SRO
Approval status of product in Tizanidine 4mg Tablets by M/s Actavis UK
Reference Regulatory Authorities Ltd (MHRA)
Me-too status Musidin 4mg Tablet by M/s Martin Dow
(Reg#037105)



Brand Name +Dosage Form + Strength Aultaroxit CR 12.5mg Tablet
Paroxetine Hcl Eq. to Paroxetine…12.5mg
Rs.20,000/- Dated 06-03-2019 (#1902356)
Pharmacological Group SSRI
Form Form-5
Approval status of product in Paxil CR 12.5mg Tablet by M/s Apotex
Reference Regulatory Authorities Technologies, USA.
Me-too status Paroxin CR 12.5mg Tablet by M/s Sharooq
Pharmaceuticals
of manufacturer from Each Film Coated
Tablet Contains: Paroxetine Hcl Eq. to
Paroxetine to Each enteric film coated
controlled release tablet contains
Paroxetine (as hydrochloride) which is
according to the reference product with fee
of 5000/- (#1926488) dated 17/8/2020
Decision: Approved, Firm shall submit the fee of Rs. 30,000 for revision of
formulation from film coated tablet to control release tablet as per notification
No.F.7-11/2012 B&A/DRAP dated 13-07-2021. Registration letter will be issued
last three years.

Brand Name +Dosage Form + Strength Diclo K 50mg Tablets
Diclofenac potassium…50mg
Rs.20,000/- Dated 06-03-2019 (#1900798)
Pharmacological Group NSAID
Form Form-5

Approval status of product in Diclofenac Potassium 50mg Film Coated
Reference Regulatory Authorities Tablets by M/s Accord Healthcare Limited,
MHRA
Me-too status NOREX TABLETS 50mg tablets by M/s
Alen Pharmaceuticals (Pvt) Ltd, Reg. No.
3172


Brand Name +Dosage Form + Strength Letro 2.5mg Tablets
Letrozole…2.5mg
Rs.20,000/- Dated 07-03-2019 (#1902385)
Pharmacological Group Non-Steroidal aromatase inhibitor
Form Form-5
As per SRO
Approval status of product in FEMARA letrozole 2.5mg coated tablet by
Reference Regulatory Authorities Novartis Pharmaceuticals Australia Pty Ltd
(TGA Approved)
Me-too status Femara 2.5mg Tablet by Novartis (Reg. No.
021129)
Decision: Approved with USP specifications. Firm shall submit the fee of Rs. 7,500
last three years
Brand Name +Dosage Form + Strength Piroxiwen 20mg Tablets
Piroxicam Betacyclodextrin…20mg
Rs.20,000/- Dated 07-03-2019 (#1900765)
Pharmacological Group Non-Steroidal aromatase inhibitor
Form Form-5

Approval status of product in PIROXICAM G GAM 20 mg, scored table
Reference Regulatory Authorities (ANSM approved)
Me-too status Piroxibet 20mg Tablets of M/s Lawari
International (Reg. # 054939)
Decision: Approved with innovator’s specifications. Firm shall submit the fee of
Rs. 7,500 for correction/pre-approval change/ in product specifications, as per

Brand Name +Dosage Form + Strength Soda 200mg Tablets
Sodium Valproate…200mg
Rs.20,000/- Dated 07-03-2019 (#1900763)
Form Form-5
As per SRO
Approval status of product in Epilim 200 Gastro-resistant tablets
Reference Regulatory Authorities (MHRA)
Me-too status Epilim E.C 200mg Tablet by Sanofi
(#058501)
of manufacturer from
Each Film Coated Tablet Contains:
Sodium Valproate to Each gastro resistant
coated tablet contains Sodium Valproate
which is according to the reference product
with fee of 5000/- (#2038553) dated
03/9/2020
Decision: Approved with innovators specification, Firm shall submit the fee of Rs.
30,000 for revision of formulation from film coated tablet to each gastro resistant
tablet as per notification No.F.7-11/2012 B&A/DRAP dated 13-07-2021.
Registration letter will be issued after submission of GMP inspection report from
QA&LT Division, valid within last three years

Brand Name +Dosage Form + Strength Quepine 150mg Tablet
Quetiapine as Fumarate…150mg
Rs.20,000/- Dated 07-03-2019 (#1900760)
Pharmacological Group Antipsychotic
Form Form-5
Approval status of product in SEROQUEL® (quetiapine fumarate).
Reference Regulatory Authorities USFDA approved
Me-too status Ziapine XR150mg Oral Tablets Reg. No.
78755


Brand Name +Dosage Form + Strength Pentrex 40mg Tablets
Composition Each gastro resistant Tablet Contains:
Pantoprazole as Sodium
Sesquihydrate…40mg
Rs.20,000/- Dated 07-03-2019 (#1902357)
Form Form-5
Approval status of product in Pantoprazole 40 mg gastro resistant Tablet
Reference Regulatory Authorities (MHRA Approved)
Me-too status Pantopraz 40mg Tablet M/s Klifton
Pharma,
Remarks of Evaluator VII In RRA its gastro resistant not enteric
coated so firm revised their formulation
from enteric coated to gastro resistant tablet
by paying fee of 5000/- (#1926490) dated
20 aug 2020.

formulation from enteric coated tablet to gastro resistant tablet as per notification
No.F.7-11/2012 B&A/DRAP dated 13-07-2021. Registration letter will be issued
last three years

Brand Name +Dosage Form + Strength Leflunomalt 20mg Tablets
Leflunomide…20mg
Rs.20,000/- Dated 07-03-2019 (#1900799)
Pharmacological Group Immunosuppressant
Form Form-5
Approval status of product in ARAVA 20 mg film-coated tablet by Sanofi
Reference Regulatory Authorities (ANSM approved)
Me-too status Lefluno Tablet of M/s Caraway Pharma
050063


Brand Name +Dosage Form + Strength Cipro 500mg Tablets
Composition Each Film coated Tablet Contains:
Ciprofloxacin HCL Eq. to
Ciprofloxacin…500mg
Rs.20,000/- Dated 06-03-2019 (#1900787)
Form Form-5
As per SRO
Approval status of product in Ciprofloxacin tablets 500mg of M/s Special
Reference Regulatory Authorities Concept Development (UK MHRA
Approved)
Me-too status Axcin Tablets 500mg of M/s Novartis
Pharmaceuticals


Brand Name +Dosage Form + Strength Artho 75/200 mg Tablets
Diclofenac Sodium…75mg
Misoprostol…200mg
Rs.20,000/- Dated 07-03-2019 (#1902366)
Form Form-5
Approval status of product in Arthrotec 75 modified-release tablets by
Reference Regulatory Authorities M/s Pfizer, MHRA approved
Me-too status Arsofin Tablets by M/s Martin Dow
Pharmaceuticals (Pakistan) Ltd, Reg. no.
48013
Remarks of Evaluator VII Firm initially applied as
Each Film Coated Tablet Contains
Diclofenac sodium…..75mg
Misoprostol………….200mcg
Moreover, Misoprostol requires special
storage
Conditions 2-80C. On communication firm
submit revised formulation as per the
composition of reference product given in
the following along with the submission of
requisite fee of 5000/- (#1926474) dated 20
aug 2020; Each Film Coated Tablet
Contains:
Diclofenac Sodium (enteric coated
core)….……75mg
Misoprostol (1% HPMC
Dispersion)…..………..…200mcg
In RRA the product is approved as inner
enteric coated layer of diclofenac sodium
surrounded by misoprostol dispersion
coating but the firm applied as film coated
tablet.
Decision: Deferred for confirmation of manufacturing facility of bilayered tablet


Brand Name +Dosage Form + Strength Ceflar 250mg Tablets
Clarithromycin…250mg
Rs.20,000/- Dated 07-03-2019 (#1902266)
Form Form-5
Approval status of product in Clarithromycin 250 mg of Sandoz (USFDA
Reference Regulatory Authorities Approved)
Me-too status Clarmark 250mg tablet Of M/S Wel Mark
Pharmaceutical
Decision: Approved with USP specifications. Firm shall submit the fee of Rs. 7,500
last three years

Brand Name +Dosage Form + Strength Aultopride 50mg Tablets
Itopride HCL…50mg
Rs.20,000/- Dated 07-03-201 (#1902255)
Pharmacological Group Prokinatic
Form Form-5
Approval status of product in Ganaton 50mg Tablet by Abbott (PMDA
Reference Regulatory Authorities approved)
Me-too status Itoguard Tablet of M/s Macter International
of manufacturer from Itopride to Itopride
HCL which is according to the reference
product with fee of 5000/- (#1926489)
dated 17/8/2020
formulation from Itopride to Itopride HCL as per notification No.F.7-11/2012

B&A/DRAP dated 13-07-2021. Registration letter will be issued after submission
of GMP inspection report from QA&LT Division, valid within last three years

Brand Name +Dosage Form + Strength Cipro 250mg Tablets
Ciprofloxacin HCL Eq. to
Ciprofloxacin…250mg
Rs.20,000/- Dated 07-03-2019 (#1902384)
Form Form-5
Approval status of product in Ciprofloxacin tablets 250mg of M/s Special
Reference Regulatory Authorities Concept Development (UK MHRA
Approved)
Me-too status Axcin Tablets 250mg of M/s Novartis
Pharmaceuticals


Brand Name +Dosage Form + Strength Levo 500mg Tablets
Levofloxacin as hemihydrate…500mg
Rs.20,000/- Dated 07-03-2019 (#1902382)
Form Form-5
Approval status of product in Levofloxacin Tablets 500mg of M/s Actavis
Reference Regulatory Authorities Group United Kingdom (MHRA Approved)
Me-too status Leflox Tablets 500mg of M/s Getz Pharma


Brand Name +Dosage Form + Strength Stowel 10mg Tablets
Escitalopram as Oxalate…10mg
Rs.20,000/- Dated 07-03-2019 (#1902274)
Pharmacological Group Antidepressant (SSRIs)
Form Form-5
Pack size & Demanded Price 10, 14’s As per SRO
Approval status of product in Escitalopram by cresent pharma Approved
Reference Regulatory Authorities by MHRA of UK
Me-too status Zavesca tablet 10mg of Getz Pharma.
(Reg.#045279)

Brand Name +Dosage Form + Strength Dimecrotic Acid 50mg Tablets
Dimecrotic Acid…50mg
Rs.20,000/- Dated 06-03-2019 (#1900788)
Pharmacological Group Gastrointestinal drugs
Cholagogues & hepatic preparations
Form Form-5
As per SRO
Approval status of product in Could not be confirmed
Me-too status Hepadial 50mg TABLETS (Hilton Pharma),
Reg. No. 16850
Remarks of Evaluator VII Reference in RRA needed, provided
reference of fisiobil spain can’t be verified
and in ANSM HEPADIAL 50 mg, coated
tablet contains magnesium dimecrotate
Decision: Deferred for Evidence of approval of applied formulation in

reference regulatory authorities / agencies which were adopted by the Registration

483. Name and address of manufacturer / M/s Arreta Pharmaceuticals Pvt Ltd.
Applicant Plot No. 13, Street N-5, National Industrial
Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Osicare Plus Tablet
Glucosamine sulphate…500mg
Chondrotoin sulphate…400mg
Rs.20,000/- Dated 07-03-2019 (#0845203)
Pharmacological Group Other antiinflammatory and antirheumatic
agents, nonsteroids
Form Form-5
As per SRO
Approval status of product in TGA; Australia Approved
Me-too status Gevolox Ch Tablets of M/s Hilton Pharma
(Reg. # 039688)
GMP status Last inspection report dated 22-05-2018
concluded that the firm was found to be
GMP compliant.
Remarks of Evaluator VII Previously firm applied as each Tablet
Contains:
Chondrotoin sulphate…600mg which is not
present in RRA so firm revised its
formulation as Each Tablet Contains:
Chondrotoin sulphate…400mg according to
RRA with due fee of 20,000/- (#1983273)
dated 26 aug 2020. Firm also requested to
change its brand name to “Jovecare tablets”
Decision: Approved, Firm shall submit the remaining fee of Rs. 10,000 for revision
of formulation as per notification No.F.7-11/2012 B&A/DRAP dated 13-07-2021
Brand Name +Dosage Form + Strength Afexdine 120mg Tablet
Fexofenadine Hcl…120mg
Rs.20,000/- Dated 07-03-2019 (#1900441)
Pharmacological Group Antihistamines for systemic use
Form Form-5

Approval status of product in Fexotabs 120 mg tablet Approved in TGA
Me-too status Epodin 120mg Tablet M/s Epoch Pharma
(#52778)
GMP compliant.

Brand Name +Dosage Form + Strength Andreprol 100mg Tablet
Metoprolol Tartrate…100mg
Rs.20,000/- Dated 07-03-2019 (#0845207)
Form Form-5
Approval status of product in Metoprolol Tartrate 100 mg Film-coated
Reference Regulatory Authorities Tablets. MHRA approved
Me-too status Dronic 100mg Tablets, film coated. Reg.
No. 81425
GMP compliant.

Brand Name +Dosage Form + Strength Alpharich 0.5mcg Tablet
Alfacalcidol…0.5mcg
Rs.20,000/- Dated 07-03-2019 (#0588348)
Form Form-5
Finished product Specifications Manufacturer

Approval status of product in Alfacalcidol tablet 0.5mcg PMDA Japan
Reference Regulatory Authorities approved
Me-too status Alfasta Tablet 0.5mcg by M/s Star Labs,
Reg. No. 81398
GMP compliant.
Brand Name +Dosage Form + Strength Arremide 50mg Tablet
Lacosamide…50 mg
Rs.20,000/- Dated 07-03-2019 (#0588341)
Pharmacological Group Antiepilaptic
Form Form-5
Finished product Specifications Manufacture specifications
Approval status of product in VIMPAT® (lacosamide) Tablet, Film
Reference Regulatory Authorities Coated
USFDA Approved.
Me-too status Atcomid 50mg Tablet
Atco Lab. Karachi. (Reg. # 075947)
GMP compliant.
Lacosamide…100mg

Rs.20,000/- Dated 07-03-2019 (#0588340)
Form Form-5
Approval status of product in Vimpat tablet of UCB Inc, USFDA
Reference Regulatory Authorities Approved.
Me-too status Lacolep tablet of Hilton Pharma (Reg. No#
073858).
GMP compliant.
Lacosamide…150mg
Rs.20,000/- Dated 07-03-2019 (#0588342)
Pharmacological Group antiepileptic
Form Form-5
Approval status of product in VIMPAT® (lacosamide) Tablet, Film
Reference Regulatory Authorities Coated
USFDA Approved.
Me-too status Atcomid 150mg Tablet
Atco Lab. Karachi. (Reg.#075949)
GMP compliant.

Brand Name +Dosage Form + Strength Thioside 4mg Capsule
Thiocolchicoside…4mg
Rs.20,000/- Dated 07-03-2 (#0846646)
Pharmacological Group Muscle Relaxants, Centrally Acting Agents
Form Form-5
Approval status of product in MYOPLEGE 4 mg hard capsule of M/s
Reference Regulatory Authorities GENEVRIER SA Laboratories approved by
ANSM of France
Me-too status Muscodid 4mg Capsule M/s Regal
Pharmaceuticals, Rawat (Reg #081968)
GMP compliant.
Rs.20,000/- Dated 07-03-2019 (#0588349)
Pharmacological Group Other antihistamines for systemic use
Form Form-5
Approval status of product in FEXOTABS fexofenadine hydrochloride
Reference Regulatory Authorities 60mg tablet blister pack.TGA approved
Me-too status Vigil Tablets by Tabros Pharma. (Reg. No.
39776)
GMP compliant.

Brand Name +Dosage Form + Strength Andreprol 50mg Tablet
Metoprolol Tartrate…50mg
Rs.20,000/- Dated 07-03-2019 (#1902392)
Form Form-5
Approval status of product in Metoprolol Tartrate 50 mg Film-coated
Reference Regulatory Authorities Tablets. MHRA approved
Me-too status Mepresor 50mg Tablets, film-coated. Reg.
No. 36124
GMP compliant.

Rs.20,000/- Dated 07-03-2019 (#1900442)
Pharmacological Group H1 receptor antagonist
Form Form-5
Approval status of product in Fexofenadine hydrochloride film coated
Reference Regulatory Authorities tablet 180mg by M/s Cipla (MHRA
Approved)
Me-too status Epodin 180mg Tablet by M/s Epoch
Pharmaceutical, Reg. No. 58058
GMP compliant.

Brand Name +Dosage Form + Strength Misonac Tablet
Paracetamol…500mg
Caffeine…65mg
Rs.20,000/- Dated 07-03-2019 (#0846648)
Pharmacological Group Analgesic and CNS Stimulent
Form Form-5
Pack size & Demanded Price 30’s, 100’s, and 200’s
As per SRO
Approval status of product in Panadol Extra Advance 500 mg/65 mg Film
Reference Regulatory Authorities Coated Tablets by M/s GSK, MHRA
Approved.
Paracetamol and caffeine 500mg/65mg
soluble tablets (MHRA Approved)
Me-too status Cafimol Extra Tablets uncoated. Zinta
Pharmaceutical Industry (038898)
Me-too Status Paratol Extra tablet by M/s
Highnoon (Reg.# 13346)
GMP compliant.

Brand Name +Dosage Form + Strength Siliptin-M 50/500 mg Tablet
Sitagliptin as Sitagliptin Phosphate
Monohydrate…50mg
Metformin Hcl…500mg
Rs.20,000/- Dated 07-03-2019 (#0845204)
Form Form-5
Approval status of product in Janumet film coated tablet (50mg/500mg &
Reference Regulatory Authorities 50mg/1000mg) by M/s MSD, USFDA
Approved.

Me-too status Sitaglip-Plus Tablet 50/500 by M/s Maple
Pharmaceuticals (Pvt) Ltd, Reg. No. 53403
GMP compliant.
Brand Name +Dosage Form + Strength Siliptin-M 50/1000 mg Tablet
Sitagliptin as Sitagliptin Phosphate
Monohydrate…50mg
Metformin Hcl…1000mg
Rs.20,000/- Dated 07-03-2019 (#0845205)
Pharmacological Group Anti diabetic
Form Form-5
Approval status of product in Janumet film coated tablet (50mg/500mg &
Reference Regulatory Authorities 50mg/1000mg) by M/s MSD, USFDA
Approved.
Me-too status Sitaglip-Plus Tablet 50/1000 by M/s Maple
Pharmaceuticals (Pvt) Ltd, Reg. No. 53404
GMP compliant.
Brand Name +Dosage Form + Strength Utrobin 10mg Tablet
Solifenacin as Succinate…10mg
Rs.20,000/- Dated 07-03-2019 (#1900446)
Pharmacological Group Muscarinic antagonist
Form Form-5
Approval status of product in Vesicare® (5mg& 10mg) film-coated tablet
Reference Regulatory Authorities by M/s Astellas Pharma Ltd, MHRA
Approved.
Me-too status Solifen Tablet 10mg by M/s GetzPharma,
Reg. No. 61203
GMP compliant.
Brand Name +Dosage Form + Strength Nebilol 5mg Tablet
Nebivolol as Hcl…5mg
Rs.20,000/- Dated 07-03-2019 (#0846638)
Pharmacological Group Beta-1 receptor blocker
Form Form-5
Approval status of product in Bystolic 5 mg Tablet (USFDA Approved)
Me-too status Nabil Tablets 5mgM/s. Getz Pharma
GMP compliant.

Brand Name +Dosage Form + Strength Klomifen 50mg Tablet
Composition Each uncoated Tablet Contains:
Clomifene Citrate…50mg
Rs.20,000/- Dated 07-03-2019 (#1900450)
Pharmacological Group Beta-1 receptor blocker
Form Form-5
Approval status of product in GENRX CLOMIPHENE clomifene citrate
Reference Regulatory Authorities 50mg
Uncoated TGA Approved.
Me-too status Florid 50mg Tablet M/s Opal Labs, Karachi
075806
GMP compliant.
Brand Name +Dosage Form + Strength Arecrip 2.5mg Tablet
Bromocriptine as Mesylate…2.5mg
Rs.20,000/- Dated 07-03-2019 (#1900447)
Pharmacological Group Prolactine inhibitor/ Dopamine Receptor
Agonist
Form Form-5
As per SRO
Approval status of product in Bromocriptine 2.5mg Tablets by M/s. Meda
Reference Regulatory Authorities Pharma, MHRA approved
Me-too status Parlodel 2.5 mg tablet by M/s Novartis
(Reg#004714)
GMP compliant.

Decision: Deferred for the evidence of required manufacturing facility.
Brand Name +Dosage Form + Strength Arrizin 4mg Tablet
Tizanidine as Hcl…4mg
Rs.20,000/- Dated 07-03-2019 (#0846636)
Pharmacological Group Muscle relaxant
Form Form-5
Pack size & Demanded Price 10’s as per SRO
Approval status of product in Zanaflex® (tizanidine hydrochloride)
Reference Regulatory Authorities uncoated tablets, USFDA Approved
Me-too status Tizax 4mg Tablet by Searle (#076022)
GMP compliant.

Brand Name +Dosage Form + Strength Arractam 250 mg Tablet
Levetiracetam…250mg
Rs.20,000/- Dated 07-03-2019 (#0588343)
Pharmacological Group Anti-Epileptic
Form Form-5
As per SRO
Approval status of product in Levetiracetam zentiva 250 mg of MHRA
Reference Regulatory Authorities Approved
Me-too status Levep 250mg Tablet by Hilton Pharma
(Reg.
No. 053348
GMP compliant.

Brand Name +Dosage Form + Strength Arractam 750mg Tablet
Rs.20,000/- Dated 07-03-2019 (#0588345)
Form Form-5
As per SRO
Approval status of product in KEPPRA tablets USFDA Approved
Me-too status Lepsira 750mg tablets by Scilife Pharma
(Reg. 100439)
GMP compliant.

Brand Name +Dosage Form + Strength Arractam 1000mg Tablet
Rs.20,000/- Dated 07-03-2019 (#0588346)
Form Form-5
As per SRO
Approval status of product in KEPPRA (250mg, 500mg, 750mg,
Reference Regulatory Authorities 1000mg) film coated tablets USFDA
Approved
Me-too status Elicia 1000mg Tablet of Martin Dow
(Reg.#081157)
GMP compliant.

Brand Name +Dosage Form + Strength Utrobin 5mg Tablet
Solifenacin as Succinate…5 mg
Rs.20,000/- Dated 07-03-2019 (#1900445)
Pharmacological Group Muscarinic antagonist
Form Form-5
Approval status of product in Vesicare (5mg& 10mg) film-coated tablet
Reference Regulatory Authorities by M/s Astellas Pharma Ltd, MHRA
Approved.
Me-too status Solifen Tablet 5mg by M/s GetzPharma,
Reg. No. 61202
GMP compliant.
Decision: Approved with innovators specifications. Firm shall submit the fee of
notification No.F.7-11/2012- B&A/DRAP dated 07-05-2021Registration letter will
Brand Name +Dosage Form + Strength Misonac plus Tablet
Paracetamol…500mg
Caffeine…65mg
Chlorpheniramine (Maleate)…….2 mg
Rs.20,000/- Dated 07-03-2019 (#1902392)
Pharmacological Group Analgesic and CNS Stimulent
Form Form-5
Me-too status Hesmol Extra tablets of Wisdom
Pharmaceuticals

GMP compliant.
Remarks of Evaluator VII Evidence in RRA
Decision: Deferred for evidence of approval of the applied product in reference

regualtory authorities/agencies which were declared/approved by Registrtaion
507. Name and address of manufacturer / M/s Avensis Pharmaceuticals.
Applicant F-24/1, Estern Industrial Zone, Port Qasim,
Karachi, Pakistan
Brand Name +Dosage Form + Strength Gentasis 80mg/2ml Ampoule
Gentamicin as Gentamicin Sulphate…80mg
Rs.20,000/- Dated 05-03-2019 (#0703856)
Pharmacological Group Aminoglycoside Antibacterial
Form Form-5
As per SRO
Approval status of product in Cidomycin 80mg/2ml Solution for Injection
Reference Regulatory Authorities (5 x 2ml colourless glass ampoules (Type I)
by M/s Aventis Pharma Limited (MHRA
Approved)
Me-too status Refobacin 80mg/2ml Injection by AD
Marker Quetta (Reg. #006473)
GMP status CLB in its 267th meeting held on 31st Dec,
2018 has considered and approved the grant
of DML to Avensis Pharmaceuticals by way
of Formulation for nine sections:


Karachi, Pakistan
Brand Name +Dosage Form + Strength Lexus 20 mg
Furosemide…20mg
Rs.20,000/- Dated 05-03-2019 (#0826527)
Pharmacological Group Loop Diuretics
Form Form-5
Pack size & Demanded Price 2 ml
As per SRO

Approval status of product in Furosemide 20mg /2ml solution for
Reference Regulatory Authorities Injection (MHRA approved)
Me-too status Lasix Injection of Sanofi Aventis
(Reg#000230)


Karachi, Pakistan
Brand Name +Dosage Form + Metolide 10mg/2ml Ampoule
Strength
Metoclopramide as Metoclopramide
Hcl…10mg
Rs.20,000/- Dated 07-03-2019 (#0761625)
Pharmacological Group Antiemetic
Form Form-5
Approval status of product in Approved in US-FDA
Me-too status Vominor 10mg Injection of Nortech
Pharmaceuticals
notification No.F.7-11/2012- B&A/DRAP dated 07-05-2021.Registration letter
will be issued after submission of GMP inspection report from QA&LT Division,
valid within last three years
Karachi, Pakistan
Brand Name +Dosage Form + Atropine 1mg/ml Injection
Strength
Composition Each ml Ampoule Contains:
Atropine Sulphate…1mg
Rs.20,000/- Dated 07-03-2019 (#0761616)
Pharmacological Group Anti- cholinergic

Form Form-5
Approval status of product in Atropine Sulfate Injection 1mg in 1 ml
Reference Regulatory Authorities (MHRA)
Me-too status Atropine Injection By M/s. Alina: 049677

Karachi, Pakistan
Brand Name +Dosage Form + D-Spa 40mg/2ml Injection
Strength
Drotaverine Hcl…40mg
Rs.20,000/- Dated 06-03-2019 (#0839015)
Pharmacological Group Antispasmodic
Form Form-5
Approval status of product in Approved in 3 European countries
Me-too status NO-SPA INJECTION. Reg No. 08296
VII
notification No.F.7-11/2012- B&A/DRAP dated 07-05-2021.Registration letter will
Karachi, Pakistan
Brand Name +Dosage Form + Ketamile 500mg/10ml Ampoule
Strength
Ketamine as Ketamine Hcl…500mg
Rs.20,000/- Dated 07-03-2019 (#0826521)
Pharmacological Group General anesthetics (N01AX03)

Form Form-5
Pack size & Demanded Price 10ml glass ampoule, As per SRO
Approval status of product in Ketalar
10-mL multi-dose vial
Me-too status Ketarol Injection 50mg/ml
M/s Global Pharmaceuticals, Islamabad;
026630
Remarks of Evaluator VII In RRA its in Vial

Karachi, Pakistan
Brand Name +Dosage Form + Avebion Ampoule
Strength
Thiamine Hcl…100mg
Pyridoxine Hcl…100mg
Cyanocobalamin…1000mcg
Rs.20,000/- Dated 07-03-2019 (#0826520)
Pharmacological Group B-complex vitamin
Form Form-5
Approval status of product in Neurobion Injection by M/s Merck
Reference Regulatory Authorities (Germany) Merck
Me-too status Neurobion Injection by Merck (Reg. No.
001485)
Decision: Approved with innovator’s specifications with shelf life of 12 Months.

Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in
product specifications, as per notification No.F.7-11/2012- B&A/DRAP dated 07-
05-2021.Registration letter will be issued after submission of GMP inspection
report from QA&LT Division, valid within last three years
Karachi, Pakistan

Brand Name +Dosage Form + Gravisis 50mg/ml Injection
Strength
Dimenhydrinate …50mg
Rs.20,000/- Dated 07-03-2019 (#0826524)
Pharmacological Group Antiemetic
Form Form-5
Approval status of product in Dimenhydrinate Injection of Fresenius Kabi,
Reference Regulatory Authorities USFDA Approved.
Me-too status Corinate 50mg/ml Inj. of Asian continental
(Reg#057863).

Karachi, Pakistan
Brand Name +Dosage Form + Piromax 20mg/ml Injection
Strength
Piroxicam…20mg
Rs.20,000/- Dated 07-03-2019 (#0761613)
Form Form-5
Finished product Specifications Manufacturers specification
As per SRO
Me-too status Salden 20mg Injection of M/s Danas Pharma
(Reg.#080373)
of formulation for nine sections

Karachi, Pakistan
Brand Name +Dosage Form + Transit 500mg/5ml Injection
Strength
Rs.20,000/- Dated 07-03-2019 (#0826522)
Pharmacological Group Antifibrinolytic
Form Form-5
Pack size & Demanded Price 5’s, 10’s, 20’s as per SRO
Approval status of product in CYKLOKAPRON 500mg Solution for
Reference Regulatory Authorities Injection by M/s Pfizer Limited, MHRA
Me-too status Tremic -500 Injection of M/s M/s Fynk
Pharmaceuticals,
Karachi, Pakistan
Brand Name +Dosage Form + Transit 250 mg/5ml Injection
Strength
Rs.20,000/- Dated 07-03-2019 (#0826523)
Pharmacological Group Antifibrinolytic
Form Form-5
Pack size & Demanded Price 5’s, 10’s, 20’s As per SRO
Approval status of product in PMDA approved
Me-too status Dravix 250mg/5ml Injection of Getz Pharma
Karachi

Karachi, Pakistan
Brand Name +Dosage Form + Ketrolav 30mg/ml Ampoule
Strength
Ketrolac Trometamol…30mg
Rs.20,000/- Dated 07-03-2019 (#0826526)
Pharmacological Group Anti-inflammatory and Anti-rheumatic
Products, Non-Steroids
Form Form-5
Pack size & Demanded Price 5’s, 25’s As per SRO
Approval status of product in Tora-Dol 30 mg/ml
Reference Regulatory Authorities AIFA Approved
Me-too status Orkit Injection IV
Aulton Pharmaceuticals (080560)

Karachi, Pakistan
Brand Name +Dosage Form + Kinza 20mg/ml Ampoule
Strength
Nalbuphine Hcl…20mg
Rs.20,000/- Dated 07-03-2019 (#0841037)
Pharmacological Group Potent analgesic.
Form Form-5
Approval status of product in NUBAIN – (nalbuphine hydrochloride)
Reference Regulatory Authorities injection (1ml ampule), for intramuscular,
subcutaneous, or intravenous (USFDA).
Me-too status Nalfy Injection 20mg. Reg. No. 81911

Karachi, Pakistan
Brand Name +Dosage Form + D-Fenac 75mg/3ml Injection
Strength
Diclofenac Sodium…75mg
Rs.20,000/- Dated 07-03-2019 (#0826525)
Pharmacological Group NSAID
Form Form-5
Reference Regulatory Authorities injection for intramuscular, subcutaneous, or
intravenous (USFDA).
Me-too status Nalfy Injection 20mg. Reg. No. 81911
Karachi, Pakistan
Brand Name +Dosage Form + Adrenaline 0.1% Injection
Strength
Composition Each Ampoule Contains:
Adrenaline…1mg
Rs.20,000/- Dated 07-03-2019 (#0761617)
Pharmacological Group adrenergic
Form Form-5
As per SRO
Approval status of product in Adrenaline solution for ijection (MHRA)
Me-too status Adrenaline injection by Elite (#026237)

notification No.F.7-11/2012- B&A/DRAP dated 07-05-2021.Registration letter will
Karachi, Pakistan
Brand Name +Dosage Form + Codomax 500/15 mg Tablet
Strength
Paracetamol…500mg
Codeine phosphate hemihydrate…15mg
Rs.20,000/- Dated 07-03-2019 (#0841047)
Pharmacological Group Opioid analgesic
Form Form-5
As per SRO
Approval status of product in Co-codamol 15/500 Tablets of Zentiva
Reference Regulatory Authorities Pharma UK Limited
Me-too status Lowmol Tablets (Reg. 040426) of Lowit
Pharma (Pvt) Ltd
VII
Remarks of Evaluator In RRA Codeine phosphate hemihydrate not
just codien No master formulation and
method of manufacturer
Decision: Deferred for the following;

• Submission of method of manufacturign and master formulation.
• Submission of correct label claim since the reference product contains
Codeine Phosphate Hemihydrate while you have applied for Codiene (base)
only.
Karachi, Pakistan
Brand Name +Dosage Form + Montysis 4mg Sachet
Strength
Composition Each Sachet Contains:
Montelukast as Montelukast Sodium oral
granules …4mg
Rs.20,000/- Dated 07-03-2019 (#0841018)

Pharmacological Group Leukotriene antagonist
Form Form-5
Pack size & Demanded Price 10’s, 14’s
As per SRO
Approval status of product in Singulair Sachet 4mg Granules of Merck,
Reference Regulatory Authorities USFDA
Me-too status Montiget Sachet of M/s Getz Pharma
(Reg.# 044046

Karachi, Pakistan
Brand Name +Dosage Form + Stilmix 10mg Tablet
Strength
Zolpidem Tartrate…10mg
Rs.20,000/- Dated 07-03-2019 (#0813648)
Pharmacological Group Sedative
Form Form-5
Pack size & Demanded Price 10’s, 14’s
As per SRO
Approval status of product in Stilnoct (5mg, 10mg) film-coated Tablets by
Reference Regulatory Authorities M/s Sanofi, MHRA Approved.
Me-too status Olida 10mg Tablets of M/s Glitz
Pharmaceuticals, Islamabad (Reg.# 081418)
GMP status Inspection dated 28-11-2018 for DML,
CLB in its 267th meeting held on 31st Dec,
Decision: Deferred for confirmation of requisite manufacturing facility that is

Tablet Psychotropic Section.
Applicant F-24/1, Eastern Industrial Zone, Port Qasim,
Karachi, Pakistan
Brand Name +Dosage Form + Kinza 10mg/ml Ampoule
Strength

Nalbuphine Hcl…10mg
Rs.20,000/- Dated 07-03-2019 (#0841036)
Pharmacological Group Potent analgesic.
Form Form-5
Reference Regulatory Authorities injection for intramuscular, subcutaneous, or
intravenous (USFDA).
Me-too status Sonotic injection of M/s Brookes Pharma
(Reg. # 057729)
Case no. 02 Registration applications of drugs for which stability study data is submitted
Registration applications for Form 5F
a) newly granted DML or New section (Human)
Case No. 01: M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2, Phase 3, Industrial estate, hattar, Haripur.
M/s M/s Sayyed Pharmaceutical (Pvt) Ltd,67/2, Phase 3, Industrial estate, hattar, Haripur has been
granted additional section Tablet section (Psychotropic) section) dated 07-04-2020 by Licensing
division DRAP. Now the firm has submitted following applications as per the details mentioned in
the table below:
Tablet section (Psychotropic): 01 Molecules / 01 Products
526. Name, address of Applicant / Marketing M/s Sayyed Pharmaceutical (Pvt)
Authorization Holder Ltd,67/2,Phase 3,Industrial estate,hattar,Haripur.
Name, address of Manufacturing site. M/s Sayyed Pharmaceutical (Pvt)
Ltd,67/2,Phase 3,Industrial estate, hattar,
Haripur.
☐ Importer
giver)

☐ Export sale
Zolsyd 10mg tablet
name
Strength / concentration of drug of Each film Coated tablet contains:
Active Pharmaceutical ingredient (API) Zolpidem tartrate…….10mg
per unit
Pharmaceutical form of applied drug White, Round shaped, bisect film coated tablet
Pharmacotherapeutic Group of (API) Imidazopyridine
USP
specifications
Ambien 10mg tablet (USFDA Approved).
authorities
For generic drugs (me-too status) Somnia 10 mg Tablet by M/s Wilshire
GMP status of the Finished product New Section approved on 09/04/2020
manufacturer Tablet (Psychotropic)
Name and address of API manufacturer. M/s Cambrex Profarmaco Milano S.R.L Via
Curiel,34-20067 Paullo-Milano, Italy.
submitted.
Module III (Drug Substance) Official monograph of Zolpidem tartrate is
controls, tests for impurity A & related
substance, (N,N-Dimethyl-2-(7-methyl-2-p-
tolylimido[1,2-a]pyridine-3-yl)acetamide
substance
Stability studies of API Stability study conditions:
months

months
Batches: (010101), (010202), (010303)

comparative dissolution profile established against the Comparator product that
is Downox 10mg tablet by Martin Dow by
that is Downox 10mg tablet by Martin Dow in
Acid media (pH 1.2) (pH 4.5) & Phosphate
Buffer (pH 6.8). The values for f1 and f2 are in
the acceptable range.
specificity.
Remarks:
The formulation is same as innovator
2.3.P.5.2 In USP the time of dissolution is 15 minutes but firm mentioned time as 45 minutes
and at some places 30 minutes
Injection volume 10 ul instead of pharmacopeia 100 ul
In 3.2.S.4.2 analytical procedure no details of dissolution is there

Manufacturer of API M/s Cambrex Profarmaco Milano S.R.L Via Curiel,34-20067 Paullo-
Milano, Italy.
API Lot No. 188439
Description of Pack
(Container closure Alu-PVC blister packed in unit carton (2×10’s)
system)
Batch No. Trial-01 Trial-02
Batch Size 5000 tab 5000 tab

No. of Batches 02
the firm (if any)
32. Approval of API/ DML/GMP certificate Copy of GMP certificate No. II-API/44/H/2019
of API manufacturer issued by concerned issued by Italian Medicine Agency.
33. Documents for the procurement of API • Copy of letter No. F.5-4/2020-CD (M-
with approval from DRAP (in case of 71)dated 11/11/2020 for the purpose of
import). test/analysis and stability studies is granted.
• Invoice No.1000002020 dated 18/12/2020
sheets etc.
testing
accelerated)
S No Section #. Deficiencies Reply
1. 1.6.5 Valid Drug Manufacturing GMP Certificate valid till 30-1-

License issued by the 2022 was provided
relevant regulatory
origin is needed as the
provided one is valid till
January 2021
2. 3.2.P.4.5 Regarding query that COA of magnesium stearate
Excipients of Human or attached. No contamination with
Animal Origin shall be TSE/BSE –Rist materials
addressed for the use of
“Magnesium stearate” in
the applied formulation
For excipients of human or
animal origin, a certificate
shall be provided,
confirming that the
excipient(s) are free from
BSE and TSE. the firm
provided the certificate
from “Peter geven” that
this magnesium stearate is
from plant source

3. 3.2.P.4.5 The detailed analytical Provided
procedure of active
pharmaceutical ingredient
details of dissolution is
provided in 3.2.P.5.2 in the
analysis procedure of
finished product
4. 3.2.P.5 In USP the time of Firm has following USP
dissolution is 15 min but dissolution test 1 in which
firm mentioned time as 45 dissolution time is 15 minutes. firm
minutes and at some as followed same dissolution time
places 30 minutes. as 15 minutes as per USP
Justification is needed throughout the stability study till
now and same 15 minutes in
mentioned as analytical reports.
Also 15 minutes mentioned in
analytical procedure
5. 3.2.P.5 In assay the injection 100 µl injection loop is fixed from
volume prescribed inn the manufacturer with our HPLC.
USP is 25 ul but firm used By using 100ul injection volume
100 ul. justification is concentration of standard and
needed sample increased 4 time to
injection volume mentioned in
USP i.e 25 ul and proportionally
area also increased of standard and
sample which obey beer lambert
law, which states that there is linear
relation between concentration and
absorbance of a solution.
By Using 100 µl, RSD of standard
in the assay is less than 2%, which
is within the limit
In method verification of linearity,
study was conducted on increased
concentration (Data submitted)
6. • As per relevant As analysis of formulation
guidelines & structure of development was finished before
Form 5F, Comparative two days of CDP end date, that’s
Dissolution profile and why that date on which formulation
comparative assay has to development analysis was finished,
be performed at the time of was considered as initial stability
formulation development, date
while according to your Stre Formula CDP
submitted data, ngth tion end
Comparative Dissolution develop date
profile studies and ment
comparative assay have analysis
been performed after finished
commencing stability date
studies. Justification shall 0.5 01/03/2021 03/03/2021
be submitted. mg
0.25 17/03/2021 19/03/2021
mg
1 mg 24/03/2021 25/03/2021

7. Letter of approval for Firm provides the Letter # 5-
import of 1/2021-CD(M73) of approval for
narcotic/psychotropic import of narcotic/psychotropic
substance for substance (Clonazepam) for
manufacturing of trial manufacturing of trial batches and
batches and conduction of conduction of stability studies
stability studies
Decision: Approved.
• Registration letter will be issued after submission of Pharmaceutical equivalence and
Comparative Dissolution Profile against innovator drug product.
Case No. 01: M/s Shaigan Pharmaceuticals Limited, Post Office Dahgal, 14-Km Adyala Road
Rawalpindi.
has been granted additional facility of dry powder section dated 13 january 2022 by Licensing
division DRAP. Now the firm has submitted following applications as per the details mentioned in
the table below:
01 Molecules / 01 Products
527. Name, address of Applicant / M/s Shaigan Pharmaceuticals Limited, Post

Marketing Authorization Holder Office
Dahgal, 14-Km Adyala Road Rawalpindi.
Name, address of Manufacturing M/s Shaigan Pharmaceu9

site. 36ticals (Pvt.) Ltd.
14-Km Adyala road, Post office Dahgal,
Rawalpindi.
☐ Importer
giver)
GMP status of the firm GMP certificate issued on
8/12/2021
Evidence of approval of Firm has submitted copy of section approval
manufacturing facility letter dated 13-01-2022 which specifies Oral Dry
powder suspension (general) section.
Dy. No. and date of submission Dy. No: 5413 25/02/2022
Details of fee submitted PKR 30,000/-: 25/02/2022 (#255776532)

The proposed proprietary name / Famot Dry Suspension
brand name
Strength / concentration of drug of Each 5ml (after reconstitution) contains:
Active Pharmaceutical ingredient Famotidine……40mg
(API) per unit
Pharmaceutical form of applied drug Dry suspension
Pharmacotherapeutic Group of H2 Receptors antagonists
(API)
specifications
Proposed Pack size 50ml, 60ml, 90ml, 120ml
Proposed unit price As per S.R.O
The status in reference regulatory “PEPCID” Approved by
authorities Merck & CO.,INC,USA
For generic drugs (me-too status) APSIN (Reg. No.: 046460) manufactured by
Safron Pharmaceuticals (19 km Sheikhupura
Road Faisalabad Pakistan.)
Name and address of API Famotidine Vaasavaa Pharamceuticals Pvt. Ltd
manufacturer. Plot NoC-216,MIDC,Chincholi,Solapur-413
255,Maharashtra India
properties, solubility’s, physical form,
product.
general properties, solubility’s, physical form,
Stability Studies of Drug Substance Famotidine: Firm has submitted stability study
(Conditions duration of Stability data of 3 batches of drug substance at both
studies) accelerated as well as real time conditions. The
accelerated stability data is conducted at 40°C ±
2°C / 75% ± 5% RH for 6 months. The real time
5% RH for 60 months.

stability.
Pharmaceutical Equivalence Profile Pharmaceutical Equivalence Studies Profile has
been done against reference product of Zapsin
Dry Suspension
Manufacturer of APIs Famotidine Vaasavaa Pharmaceuticals Pvt. Ltd plot NoC-
216,MIDC,Chincholi,Solapur-413 255,Maharashtra India
API Lot No. Famotidine: 2002475
Description of Pack
Amber color bottle
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. T-001 T-002 T-0003
Batch Size 1000 1000 1000
Date of Initiation 05.2019 05.2019 05.2019
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report for
applications with stability study data Emdagan 10mg & 20mg Tablets conducted on
of 10-06-2021, approved in 307th meeting of
the firm (if any) Registration Board.

team.

2. Approval of API/ DML/GMP Famotidine:
certificate of API manufacturer Copy of GMP issued in the name of Vaasavaa
issued by concerned regulatory Pharamceuticals Pvt. Ltd Plot NoC-
authority of country of origin. 216,MIDC,Chincholi,Solapur-413
255,Maharashtra India., valid upto 19-07-2022
3. Documents for the procurement of Copy of commercial invoice attested by AD I&E

API DRAP has been submitted.
with approval from DRAP (in case Famotidine:
of Date of
Batch Invoice Quantity
Import). approval
No. No. Imported
by DRAP
FAM- EPY20-
200 Kg 04/12/2020
1120183 21/335
Firm has submitted data of stability batches
along with Chromatograms, raw data sheets,
COAs and summary data sheets.
sheets etc.
Firm has submitted 21 CFR evidence and audit
trail reports of product testing.
on product testing.
temperature & humidity monitoring
for temperature & humidity monitoring of
of stability chambers
stability chambers (real time and accelerated)
Analysis is according to USP
S.No Section Deficiency/Remarks Reponses

1. Approval of API/ DML/GMP Famotidine:
certificate of API manufacturer Copy of GMP issued in the
issued by concerned regulatory name of Vaasavaa
authority of country of origin. Pharamceuticals Pvt. Ltd Plot
NoC-
216,MIDC,Chincholi,Solapur-
413 255,Maharashtra India.,
valid upto 19-07-2022
2. 3.2.P.2.5 The microbial attributes and Submitted
preservative effectiveness study
is required
3. 3.2.P.8.3 Submission of Volume of Details of Volume of diluent
diluent for reconstitution along (45 ml) for reconstitution
with justification (weight/ml along with justification with
calculation) with reference to reference to
innovator/reference product. innovator/reference product is
submitted
4. 3.2.P. Submission of Stability data of Stability data of
reconstituted suspension up to reconstituted suspension up to
proposed shelf life is submitted proposed shelf life of 30 days
is submitted

Decision: Approved.
• Registration letter will be issued after submission of Pharmaceutical equivalence with
either innovator or brand leader if innovator is not available in Pakistan.
Enzon Pharma Labs Pvt Ltd, 5 km off Raiwind Manga Road, Lahore
CLB in its 273 meeting held on 15th January 2020 has considered and approved the grant of DML
by way of
Formulation. Now firm has applied for following products.
528. Name, address of Applicant / Marketing Enzon Pharma Labs Pvt Ltd
Authorization Holder 5 km off Raiwind Manga Road, Lahore
Name, address of Manufacturing site. Enzon Pharma Labs Pvt Ltd
5 km off Raiwind Manga Road, Lahore
☐ Importer
(contract giver)
☐ Export sale
Ensol- Metro 0.5% IV Infusion 100 mL
name
Active Pharmaceutical ingredient (API) Metronidazole…….................0.5% w/v
per unit
Pharmaceutical form of applied drug Intravenous Injection
Pharmacotherapeutic Group of (API) Other IV Solution Additives
ATC CODE: J01XD01
BP
specifications
Proposed Pack size 100 mL LDPE bottle w/ Eurocap
The status in reference regulatory Metronidazole 500 mg / 100 ml
authorities Intravenous Infusion
Baxter Healthcare Ltd.
Caxton Way Thetford Norfolk
IP24 3SE, UK

For generic drugs (me-too status) Flagyl Injection
Sanofi- aventis Pakistan Limited Plot
23, Sector 22 Korangi Industrial Area,
Karachi
GMP status of the Finished product New DML Approved. Last inspection
manufacturer conducted on 15 & 16-10-2020 and report
concludes that overall evaluation of
inspection report rating is Good
Name and address of API manufacturer. Hubei Hongyuan Pharmaceutical
Technology Co., Ltd.,
No.428, Yishui North Road, Fengshan
Town, Luotian County, Hubei Province,
China
WHO QOS-PD template. Summarized
Module III (Drug Substance) Firm has submitted relevant information
against the Module III, including Process
validation protocol, Finished product
analytical method validation report &
stability studies data of drug substance
60 months
for 6 months
Batches: (031201, 031202 and 031203)
procedure, its verification studies, batch
product.
Pharmaceutical equivalence and Firm has submitted Pharmaceutical
comparative dissolution profile equivalence study of their product with
Flagyl injection”. Batch # AH324 of
M/S Sanofi Aventis
Comparative dissolution studies are not
applicable

Analytical method Method verification studies has been
validation/verification of product submitted including accuracy, precision,
specificity and robustness.
Manufacturer of API Hubei Hongyuan Pharmaceutical Technology Co., Ltd.,
No.428, Yishui North Road, Fengshan Town, Luotian County,
Hubei Province, China
API Lot No. 0182007017
Description of Pack
100 mL LDPE Bottle
Batch No. A B C
Batch Size 100 L 100 L 100 L
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP certificate Copy of GMP Certificate (Certificate No.
of API manufacturer issued by concerned # HB20180424) for Hubei Hongyuan
regulatory authority of country of origin. Pharmaceutical Technology Co., Ltd.,
China issued by China food & Drug
Administration valid up to 30-07-2023 is
submitted
3. Documents for the procurement of API Firm has submitted copy invoice
with approval from DRAP (in case of (invoice# HTIE20-155SQ) dated: 04-07-
import). 2020 from for Hubei Hongyuan
Pharmaceutical Technology Co., Ltd.,
China cleared by DRAP Lahore office
dated 19-07-2020.
sheets etc.
testing

accelerated)
S. No Sections Observations/Deficiencies/ Short- Response by the Firm

comings
1. 3.2.P.8 Commercial invoice of The commercial invoice of
Metronidazole was provided by Metronidazole being issued
Shaoxing Hantai import and export by Shaoxing Hantal Import
Co Ltd. not Hubei Hongyuan & Export Co, Ltd because
Pharmaceutical Technology Co., they are the importer and
Ltd. Clarification is needed material is procured with
approval from DRAP
2. 1.5.9 Reference of previous approval of Ensol- NS 0.9% (25ml,
applications with stability study 100ml, 500ml, 1000ml)
data of the firm (if any) Ensol- WFI (5ml, 10ml,
20ml)
Ensol- 5% (100ml, 500ml,
1000ml)
Ensol- DS (500ml, 1000ml)
Ensol- RL (500ml, 1000ml)
3. 3.2. Justify why the pharmaceutical The comparison of the
P.2.2.1 equivalence was established against developed formulation is
comparator product instead of using against the comparator
innovator / reference product. product because CTD
guidelines clearly
mentioned that the applicant
may compare their product
with the innovator /
reference / comparator
product
4. 3.2.P.2.3 Scientific justification is required Relevant Guidelines for
regarding the temperature and terminal sterilization allow
duration of sterilization in the performance of steam
autoclave, sterilization of applied sterilization by applying
product has been done at 106 °C for reduce temperature and
1 hour while the conventional time other than that of
condition is 121°C for 15min. reference condition i.e., ≥
121°C, ≥ 15 min, while
considering the nature of
product and container
closure system
Following two conditions
shall be ensured while
applying steam sterilization
other than that of the
reference conditions.
Minimum sterilization cycle
of F° ≥ 8 minutes. Sterility
assurance level (SAL) of
10-6 is achieved. As
evident form of the
submitted data, the SAL of

10-6 has been achieved
while applying temperature
of 106°C for 60 minutes,
hence fulfilling the
mandatory requirements of
guidelines
5. 3.2. P.5.2 Provide detailed analytical The detailed analytical
procedure of Bacterial Endotoxin procedure of sterility test of
Testing test and sterility test of drug drug product is submitted
product
6. Analysis is by UV The detailed of Analytical
spectrophotometer as per BP procedure of metronidazole
requirements infusion as per BP
requirements is submitted
Decision: Approved.
throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted
in
the registration application.
529. Name, address of Applicant / Enzon Pharma Labs Pvt Ltd
Marketing Authorization Holder 5 km off Raiwind Manga Road, Lahore
5 km off Raiwind Manga Road, Lahore
☐ Importer
giver)
Ensol- 25% IV Infusion 1000 mL
brand name
Strength / concentration of drug of Each mL contains:
Active Pharmaceutical ingredient Glucose Anhydrous……….250mg
(API) per unit
Pharmaceutical form of applied drug Intravenous Injection
Pharmacotherapeutic Group of (API) Other IV Solution Additives
ATC CODE: V06DC01
BP
specifications

Proposed Pack size 1000 mL LDPE with Eurocap
The status in reference regulatory Glucose 25% Intravenous Infusion BP of
authorities Baxter Healthcare Pty Ltd.
1 Baxter Drive OLD TOONGABBIE NSW
2146 AUSTRALIA
For generic drugs (me-too status) Sterifluid- 25 (Intravenous Infusion BP)
Frontier Dextrose Ltd.
Plot No. 18/3, Phase- 1 Hatter Industrial
Estate Haripur Pakistan
GMP status of the Finished product New DML Approved. Last inspection
manufacturer conducted on 15 & 16-10-2020 and report
concludes that overall evaluation of
inspection report rating is Good
Name and address of API Weifang Shengtai Medicine Co., Ltd. The
manufacturer. East of Changda Road, Changle county,
Weifang Shandong, China.
months
6 months
Batches: (W20150514, W20150515 and
W20150516)

Pharmaceutical equivalence and Pledex 25% dextrose solution by Otsuka
comparative dissolution profile Pakistan (1000 ml) verified by section.
Analytical method Method verification studies has been
validation/verification of product submitted including accuracy, precision,
Manufacturer of API Weifang Shengtai Medicine Co., Ltd. The East of Changda Road,
Changle county, Weifang Shandong, China.
API Lot No. 20200427-2
Description of Pack
1000 mL LDPE Bottle with eurocap
Batch No. A B C
No. of Batches 03
the firm (if any)
2. Approval of API/ DML/GMP Copy of GMP Certificate (Certificate No. #
certificate of API manufacturer issued SD20180787) for Weifang Shengtai
by concerned regulatory authority of Medicine Co., Ltd. The East of Changda
country of origin. Road, Changle county, Weifang Shandong,
submitted
3. Documents for the procurement of API Firm has submitted copy invoice (invoice#
with approval from DRAP (in case of WFST312) dated: 28-04-2020 from
import). Weifang Shengtai Medicine Co., Ltd. The
East of Changda Road, Changle county,
Weifang Shandong, China cleared by
DRAP Lahore office dated 01-06-2020.
sheets etc.
testing

accelerated)
Me too Pledex 25% dextrose solution by Otsuka Pakistan (1000 ml) was verified by section.
S. No Sections Observations/Deficiencies/ Reply

Short-comings
1. 1.5.9 Evidence of approval / The product is registered in same
registration / marketing status composition, salt and dosage form
of the applied formulation in in TGA Australia Glucose 25%
the same composition, salt 1000 ml by Baxter healthcare
form and dosage form in one of Australia
the reference regulatory
authority specified by
Registration Board.
2. 1.5.9 Reference of previous approval Ensol-///ns 0.9% (25 ml, 100ml,
of applications with stability 500ml, 1000ml)
study data of the firm (if any) Ensol-RL (500ml,1000ml)
3. 3.2. S.4.3 • Submitted Analytical Submitted Analytical Method
Method Verification report Verification report
describe the same procedure
for preparation of different
sample concentration in
performance of accuracy
parameter for Glucose
anhydrous.
• Describe sample
preparation procedure for
performance of precision
parameter for Glucose
anhydrous.
4. 3.2. S.4.4 • COA of drug substance The updated COA of drug
Glucose anhydrous from substance from drug product
drug substance manufacturer is provided along
manufacturer include with supporting documents
pyrogen Testing and total
bacterial/mold and yeast
count test for confirmation
of sterility of drug substance
but same test has not been
included in the COA of drug
substance from drug
• Evidence of availability of
HPLC equipped with
refractometer and column
oven to maintained the
temperature at 85°C as per
the chromatographic
condition given in BP.
5. 3.2. S.5 COA of reference standard of Firm has submitted that the COA
anhydrous glucose is submitted, of reference standard of Glucose

while according to BP glucose anhydrous is submitted instead of
hydrous chemical reference Glucose Monohydrate erroneously
standard is used to analyze the by our analyst, hence we are
quality of glucose anhydrous. submitting the COA of reference
Justification is required for standard of Glucose Monohydrate.
using glucose anhydrous
reference standard for the assay.
6. 3.2.P.2.3 Scientific justification isRelevant Guidelines for terminal
required regarding the sterilization allow the performance
temperature and duration of of steam sterilization by applying
sterilization in autoclave, reduce temperature and time other
sterilization of applied product than that of reference condition
has been done at 106 °C for 1 i.e., ≥ 121°C, ≥ 15 min, while
hour while the conventional considering the nature of product
condition is 121°C for 15min. and container closure system
.Following two conditions shall be
ensured while applying steam
sterilization other than that of the
reference conditions. Minimum
sterilization cycle of F° ≥ 8
minutes. Sterility assurance level
(SAL) of 10-6, is achieved. As
evident form of the submitted data,
the SAL of 10-6 has been achieved
while applying temperature of
106°C for 60 minutes, hence
fulfilling the mandatory
requirements of guidelines
7. 3.2. P.5.2 Provide detailed analytical Provided
procedure of Bacterial
Endotoxin Testing test and
sterility test of drug product
8. Same stability data has been Firm submitted the separate
submitted for 500ml stability data for 1000ml volume
&1000ml.Clarification required with the statement that “Same
in this regard. stability data was submitted for
500ml &1000ml erroneously by
our analyst, hence we are
submitting the actual stability data
results for each pack size
separately. We regret the
Inconvenience caused in this
regard.”
9. 3.2. P.5.3 • Submitted Analytical Firm has submitted the following
Method Verification report reply:
describe the same procedure • The details of accuracy
for preparation of different parameter of drug product is
sample concentration in given below.
performance of accuracy • ACCURACY/ RECOVERY
parameter for glucose • Prepared the three replicates of
anhydrous ENSOL- 25% INFUSION with
the active
• drug from 95% to 105% of the
label claim by taking 4.75g for
95%, 5.0g for

• 100% and 5.25g for 105% in
each 100ml volumetric flasks.
Recover the
• spiked amount by analyzing
these samples as per analytical
procedure. The
• figure No.2 will be help full in
this regard.
• Acceptance Criteria: -The
recovery should be 100 ± 2.0%
across 95–105%
• of target concentrations
Decision: Approved.
throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted
in
530. Name, address of Applicant / Marketing Enzon Pharma Labs Pvt Ltd
Authorization Holder 5 km off Raiwind Manga Road, Lahore
5 km off Raiwind Man
ga Road, Lahore
☐ Importer
(contract giver)
☐ Export sale
Dy. No. and date of submission Dy. No. 6638 dated 10 March/2022
(New license)
Details of fee submitted PKR 30,000/-: dated 22 February 2022
The proposed proprietary name / brand name Ensol- Cipro 0.2% IV Infusion 100mL
Strength / concentration of drug of Active Each 100mL contains:
Pharmaceutical ingredient (API) per unit
Ciprofloxacin as Ciprofloxacin Lactate
…….............0.2%w/v

Pharmacotherapeutic Group of (API) Antibacterial agents
ATC CODE: J01MA02
Reference to Finished product specifications BP
Proposed Pack size 100mL

The status in reference regulatory authorities CIPROFLOXACIN 2MG/ML
INFUSION by Pfizer Limited. (MHRA)
For generic drugs (me-too status) Reflox Infusion of M/s Regal

Pharmaceutical
GMP status of the Finished product manufacturer New DML Approved. Last inspection
conducted on 15 & 16-10-2020 and
report concludes that overall evaluation
of inspection report rating is Good
Name and address of API manufacturer. Zhejiang Guobang Pharmaceutical Co.,
Ltd. No.06, Weiwu Road, Hangzhou
Zhejiang China
structure, general properties,
solubilities, physical form,
60 months
for 6 months
Batches: (110504-1, 110505-1 and
110506-1)
Pharmaceutical equivalence and comparative Pharmaceutical equivalence Bacip Inf
dissolution profile 200mg /100 ml by surge pharma batch #
AH324

Analytical method validation/verification of product Method verification studies has been
submitted including accuracy, precision,
Manufacturer of API Zhejiang Guobang Pharmaceutical Co., Ltd. No.06,
Weiwu Road, Hangzhou Zhejiang China
API Lot No. 190707
Description of Pack
100mL LDPE bottle w/ Eurocap
Batch No. A B C
No. of Batches 03
1. Reference of previous approval of applications with Ensol- NS 0.9% (25ml, 100ml, 500ml,
stability study data of the firm (if any) 1000ml)
Ensol- WFI (5ml, 10ml, 20ml)
Ensol- 5% (100ml, 500ml, 1000ml)
Ensol- DS (500ml, 1000ml)
Ensol- RL (500ml, 1000ml)
2. Approval of API/ DML/GMP certificate of API Copy of GMP Certificate (Certificate
manufacturer issued by concerned regulatory No. # ZJ20190170) for Zhejiang
authority of country of origin. Guobang Pharmaceutical Co., Ltd.
No.06, Weiwu Road, Hangzhou Zhejiang
submitted
3. Documents for the procurement of API with Firm has submitted copy invoice
approval from DRAP (in case of import). (invoice# 20NVT-183) dated: 16-04-
2020 from Shanghai Nuvit biotech co
ltd china cleared by DRAP Lahore
office dated 29-04-2020.
4. Data of stability batches will be supported by attested
respective documents like chromatograms, Submitted
5. Compliance Record of HPLC software 21CFR & Submitted

humidity monitoring of stability chambers (real time
and accelerated)
USP-Injection monograph
BP-Infusion monograph
Firm use same analytical method according to BP
Master formula has ciprofloxacin lactate and lactic acid while BP monograph states that ciprofloxacin
infusion is a sterile solution prepared by the interaction of ciprofloxacin and lactic acid.
Excipients change as compare to RRA
Documents for the procurement of API with approval from DRAP (in case of import)
S. Sections Observations/Deficiencies/ Reply

No Short-comings
1. 1.5.9 Evidence of approval / The link is attached for your kind attention.
registration / marketing https://mhraproducts4853.blob.core.windows.net
status of the applied /docs/78150360f4c25d036caca70cb71988061dbd6efd
formulation in the same
composition, salt form and
dosage form in one of the
reference regulatory
authority specified by
Registration Board.
2. Master formula has Packaging material of the applied formulation is
ciprofloxacin lactate and LDPE and is different from the reference product
lactic acid while BP which is PVC bag contained in a
monograph states that polypropylene/polyester aluminium/polyester pouch.
ciprofloxacin infusion is a No explanations regarding method of manufacturing
sterile solution prepared by
the interaction of
ciprofloxacin and lactic
acid.
3. 1.33 The address of The reason for the commercial invoice of
manufacturer on invoice is Ciprofloxacin Lactate being issued by shanghai Nuvit
Shanghai Nuvit biotech co biotech co ltd china is provided
ltd china instead of
Zhejiang Guobang
Pharmaceutical clarification
is needed in this regard.
4. (2.3.S.4.3) Provide summarized Submitted
tabulated results of
verification studies
including specificity,
(method precision)
Product manufacturer
5. 2.3.P.4 The excipients are different The reference having same excipients is provided
from the reference product https://mhraproducts4853.blob.core.windows.net
in MHRA. Justification n is /docs/78150360f4c25d036caca70cb71988061dbd6efd
needed

6. 3.2. Justify why the The comparison of the developed formulation is
P.2.2.1 pharmaceutical equivalence against the comparator product because CTD
was established against guidelines clearly mentioned that the applicant may
comparator product instead compare their product with the innovator / reference /
of using innovator / comparator product. The reference of CTD guidelines
reference product. is given
7. 3.2.P.2.3 Scientific justification is Relevant Guidelines for terminal sterilization allow
required regarding the the performance of steam sterilization by applying
temperature and duration of reduce temperature and time other than that of
sterilization in autoclave, reference condition i.e., ≥ 121°C,
sterilization of applied ≥ 15 min, while considering the nature of product and
product has been done at container closure system.
106 °C for 1 hour while the Following two conditions shall be ensured while
conventional condition is applying steam sterilization other than that of the
121°C for 15min. reference conditions.
• Minimum sterilization cycle of F° ≥ 8 minutes.
• Sterility assurance level (SAL) of 10-6 , is
achieved.
As evident form of the submitted data, the SAL of 10-
6 has been achieved while applying temperature of
106°C for 60 minutes, hence fulfilling the mandatory
requirements of guidelines
Reference: EMA guidelines on the sterilization of the
medicinal product, active substance, excipient and
primary container.
(EMA/CHMP/CVMP/QWP/850374/2015)
8. 3.2. P.5.2 Provide detailed analytical Submitted
procedure of Bacterial
Endotoxin Testing test and
sterility test of drug product
Decision: Approved.
• Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted in
• Registration letter will be issued after submission of Pharmaceutical equivalence against innovator
drug product.

Registration-I
Case No.01. Correction in Label Claim/ Strength of Approved Products of M/s Adamjee
Pharmaceuticals (Pvt) Ltd., Plot 39, Sector 15, Korangi Industrial Area
Karachi (DML No. 000236)
Registration Board in its 308th meeting held on 21st-22nd June, 2021 approved the
following products of M/s Adamjee Pharmaceuticals Pvt Ltd. Plot 39, Sector 15, Korangi
Industrial Area, Karachi (DML No. 000236) as per below mentioned details:
1. Name and address of Applicant: M/s Adamjee Pharmaceuticals Pvt Ltd.
manufacturer / Applicant Plot 39, Sector 15, Korangi Industrial Area, Karachi
Manufactured By: M/s Safe Pharmaceuticals Pvt Ltd.
Plot No. C.I-20, Sector 6-B, Industrial Area, North
Karachi
Brand Name +Dosage Form+ Adpime Injection 500mg (IV/IM)
Strength
Diary No. Date of R& I & fee Dy.No 41935 dated 07-12-2018 Rs.50,000/- Dated
07-12-2018
Composition Each vial of dry substance contains:
Cefepime as HCL (with L-Arginine)…1000mg
Type of Form Form 5
Approval Status of Product in Cefipime hydrochloride 1gm Injection M/s Hospira,
Reference Regulatory Inc. (USFDA approved)
Authorities
Me-too Status Nuxipim 1gm Injection by M/s Bosch, Reg. No. 44357
GMP Status Same as stated above
a. Submission of details of products which are already being manufactured on contract.
b. Capacity assessment report of M/s safe Pharma, Karachi by already constituted panel
Decision: Approved.
2. Name and address of Applicant: M/s Adamjee Pharmaceuticals Pvt Ltd.
manufacturer / Applicant Plot 39, Sector 15, Korangi Industrial Area, Karachi
Manufactured By: M/s Safe Pharmaceuticals Pvt Ltd.
Plot No. C.I-20, Sector 6-B, Industrial Area, North
Karachi
Brand Name +Dosage Form+ Adpime Injection 500mg IM
Strength Powder for injection
Diary No. Date of R& I & fee Dy.No 41931 dated 07-12-2018 Rs.50,000/- Dated
07-12-2018
Composition Each vial of dry substance contains:
Ceftriaxone Sodium eq to Ceftriaxone…250mg
Type of Form Form 5
Approval Status of Product in Ceftriaxone powder for injection (250mg, 500mg,
Reference Regulatory Authorities 1000mg, 2000mg) by M/s Bowmed limited, MHRA
Approved.
Me-too Status Trimark 250mg Injection IM by M/s WelMark Reg.
No. 69750

GMP Status Same as stated above
a. Submission of details of products which are already being manufactured on contract.
b. Capacity assessment report of M/s safe Pharma, Karachi by already constituted panel
Decision: Approved.
Registration letter could not be issued due to disparity in strengths mentioned in composition
and alongside the brand name.
In this context original dossier could not be retrieved from available record, however, the
firm has submitted copies of DRAP’s acknowledged receipts & fee challans of 250mg and 500mg
strengths of both formulations. Furthermore, approval for registration of Cefepime Injection
1000mg and Ceftriaxone Injection 250mg have also been issued by the Registration Board in its
308th meeting.
Accordingly, the case has been placed for correction in strengths of above-mentioned
products which appears to be due to cut-paste/ typographical error.
Proceedings of 320th Meeting:
Registration Board was further apprised regarding correction required in composition/ label claim
of product at S.No.1 as the reference/ standard formulation approved by RRA contains “Cefepime
(as Hydrochloride Monohydrate) 1000mg”
Decision: Registration Board decided as under:
i. Approved correction in strength and composition of product at S.No.1 as
per following detail:
Adpime Injection 500mg
Each vial contains:
Cefepime as Hydrochloride Monohydrate (with L-Arginine)……500mg
(USP Specifications)
ii. Approved correction in strength/ label claim of product at S.No.2 as per
following detail:
Adpime Injection 250mg IM
Each vial contains:
Ceftriaxone Sodium Eq. to Ceftriaxone……250mg
iii. Furthermore, for product at S.No.1, the applicant shall submit fee of Rs.
75,000/- in the light of notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021 for pre-registration correction in composition/label claim.
Case No.02. Correction in Label Claim/ Dosage Form of Approved Products of M/s Swiss
Pharmaceuticals (Pvt) Ltd., A-159, S.I.T.E Super Highway Karachi (DML No.
000438).
Registration Board in its 295th meeting held on 08th-11th June, 2020 approved the
following products of M/s Swiss Pharmaceuticals Pvt Ltd., A-159, S.I.T.E Super Highway,
Karachi (DML No. 000438) as per below mentioned details:
1. Name and address of manufacturer M/s / Swiss Pharmaceuticals Pvt Ltd.
Applicant A-159, S.I.T.E Super Highway, Karachi, Pakistan
Brand Name +Dosage Form + StrengthLetam 100mg/ml Oral Solution
Composition Each 1 ml ampoule contains:
Levetiracetam…100 mg
Diary No. Date of R& I & fee Form-5 Dy.No 9264 dated 28-02-2019 Rs.20,000/-
Dated 28-02-2019 (#0621840)
Pharmacological Group Antiepilaptic
Form Form-5

Pack size & Demanded Price 5 ml (vial)
As per SRO
Approval status of product in ReferenceKEPPRA (levetiracetam) injection, for intravenous
Regulatory Authorities use. (USFDA)
Me-too status Lerace Injection 500mg/5ml/ Reg. No. 66949
GMP status M/s: Swiss Pharma
Last GMP inspection conducted on 18-10-2018.and
report concludes overall current GMP compliance
level is rated as good.
VII
Decision: Approved.
Registration letter could not be issued due to disparity in dosage form mentioned alongside
the brand name and as evident from label claim/ demanded pack/ RRA reference and generic
product reference.
In this context original dossier could not be retrieved from available record, however, the
firm has informed that they applied for complete range of “Levetiracetam” containing dosage forms
including:
• 250mg & 500mg Tablets (approved and registered vide M-293),
• 100mg/ml Oral Solution (approved and registered vide M-295) and
• 100mg/ml Injection which was mistakenly quoted under the name of Oral Solution with
same diary No. However, deposit slip No., applied pack, RRA and generic status are
correctly mentioned in minutes.
As evidence, the firm has also submitted copies of acknowledgement receipts, fee challans
of both applications (i.e., Oral solution and Injection) & duplicate dossier of “Letam 100mg/ml
Injection” and requested for issuance of registration letter with following details:
Svetri Injection 100mg/ml (Already registered name for Levetiracetam)
Each ml contains:
Levetiracetam……..100 mg
Accordingly, the case has been placed for correction in dosage form of above-mentioned
product which appears to be due to cut-paste/ typographical error.
Decision: Registration Board approved correction in label claim/ dosage form of above-
mentioned product as per following detail:
Letam Injection 100mg/ml
Each ml contains:
Levetiracetam…….…..100 mg
Case No.03. Correction in Decision of 316th Meeting of Registration Board

Registration Board in its 316th meeting held on 15th-18th March, 2022 approved the
following product of The Searle Company Limited F-319, S.I.T.E., Karachi as per below
mentioned details. However, below-mentioned product was not included in the decision recorded.
592. Name, address of Applicant / The Searle Company Limited F-319,
Marketing Authorization Holder S.I.T.E., Karachi, Pakistan.
Name, address of Manufacturing site. The Searle Company Limited F-319, S.I.T.E.,
Karachi, Pakistan.
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MINUTES OF 320th MEETING OF REGISTRATION BOARD

HELD ON 29th-31st AUGUST, 2022

Item Detail of Item Pages

Minutes of 320th meeting of Registration Board (29th-31st August, 2022) |1

Following members attended the meeting:

1. Ch. Zeeshan Nazir Bajar, Additional Director (BE&R/PE&R), DRAP. Member/

Item No. I: Confirmation of Minutes of 319th meetings of Registration Board.

Minutes of 320th meeting of Registration Board (29th-31st August, 2022) |2

Decision: Registration Board confirmed the minutes of 319th meeting.

Item No. II Division of Pharmaceutical Evaluation & Registration

Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

Minutes of 320th meeting of Registration Board (29th-31st August, 2022) |3

Case No. 2: Review of Reference status of Cephradine for Injection:

Minutes of 320th meeting of Registration Board (29th-31st August, 2022) |4

“The Authority, keeping in view of practical difficulties in implementation as highlighted by the

Discussion & Decision:

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S.No Section Shortcomings Communicated Reply

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The commercial invoice is in the name of M/s Pacific

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Firm has submitted that Invoice stated the address

Submitted invoices are in the name of M/s Pacific

Section# Observations Firm’s response

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5. Compliance Record of HPLC software Not applicable

Sr. Section Deficiencies Firm’s response

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Agenda of Evaluator PEC-I

Case No. I: Registration applications of Local Manufacturing submitted on Form 5F (New

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