Minutes of 296th Meeting of Registration Board

MINUTES OF 296th MEETING OF REGISTRATION BOARD
HELD ON 8th, 9th & 10th SEPTEMBER 2020.

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Item Detail of Item Pages

No.
I. Confirmation of Minutes of 295th meeting of Registration Board 03
II. Division of Pharmaceutical Evaluation & Registration. 4-2589
 Pharmaceutical Evaluation Cell (PEC) .... ...... ...... ..... 04
 Registration-I .......... ............. ............. ............. ......... 2400
 Registration-II ............. ............ ............... .............. .... 2464
 Import & Vet-I……………………………………….. 2492
 Import & Vet-II............. ................. ............ .............. .. 2512
 Post Registration-I ............... .................. ................ .... 2539

2570
 Post Registration-II ............ ............... .............. ............
2577
 RRR Section ................ ........................ ................. ......
III. Division of Biological Evaluation & Research 2590
IV. Division of Quality Assurance & Laboratory Testing 2652
V. Additional Agenda
 Division of Pharmaceutical Evaluation & Registration 2760
 Division of Biological Evaluation & Research 2866
 Division of Quality Assurance & Laboratory Testing 2874-2884
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G-9/4
Islamabad.
Minutes of 296th Meeting of Registration Board | 1

296th meeting of Registration Board was held on 08th- 10th September, 2020 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Dr.
Obaidullah, Director, Pharmaceutical Evaluation & Registration Division, DRAP. The meeting
started with recitation of the Holy Verses.
The meeting was attended by the following:-

1. Dr. Rafeeq Alam Khan, Meritorious Professor, Member
Faculty of Pharmacy, Ziauddin University, Karachi.
2. Lt.Gen.(R) Prof.Dr. Karamat Ahmed Karamat (HI-M, SI-M) Member
Former Surgeon General Pakistan
3. Maj.Gen. (R) Dr.Tahir Mukhtar Sayed, Member
Inspector General (Hospitals), Fauji Foundation, Rawalpindi
4. Mr. Iftikhar A.Choudhary, Member
Hospital Pharmacist, Lahore
5. Dr. Qurban Ali, Ex-Director General, Member
National Veterinary Laboratories, Islamabad
6. Dr. Amanullah Khan, Director, Member
Drugs Testing Laboratory, Quetta. Government of Balochistan
7. Dr. Muhammad Khalid Jawed, Director, Member
Drugs Testing Laboratory,Peshawar Government of Khyber Pakhtunkhwa
8. Mr. Muhammad Hafeez ur Rehman, Deputy Drug Controller, Member
Drugs Testing Laboratory, Rawalpindi Government of the Punjab
9. Mr. Muhammad Aslam, Deputy Draftsman-II, Member
Representative of Ministry of Law & Justice, Islamabad
10. Ch. Zeeshan Nazir, Additional Director, Member
Representative of Biological Evaluation & Research Division, DRAP
11. Dr. Hafsa Karam Ellahi, Additional Director, Member
Representative of QA&LT Division, DRAP
12. Mr. Abdullah, Member/
Additional Director (PE&R), DRAP. Secretary
13. Dr. Muhammad Akram, Dy.Animal Husbandry Commissioner, Co-Opted
M/o National Food Security & Research, Islamabad Member
Mr. Asif Jalil, Incharge PEC and respective Assistant Directors, presented the agenda of
PE&R Division. Additional Director, BE&R assisted by respective Assistant Directors to present the
agenda of Biological Evaluation & Research Division. Additional Director, QA&LT was assisted by
respective Assistant Directors to present the agenda of QA & LT Division.
Mr.Tauqeer Ul Haq, Mr.Iftikhar Hussain & Mr. Nawaz Ahmad (PPMA) and Mr. Nadeem
Alamgir & Mr.Zia Anwar (Pharma Bureau) and Mr. Khalid Saeed (PC&DA) attended the meeting as
observers.

Item No. I: Confirmation of Minutes of 295th Meeting of Registration Board.
295th meeting of Registration Board was held on 08th to 11th June, 2020. Initially draft partial
minutes regarding “Favipiravir cases related to Covid-19 management” of Pharmaceutical Evaluation
Cell, PE&R Division were distributed among the members of Registration Board on 12th June, 2020
with the request for perusal/approval till 13th June, 2020. All members agreed draft partial minutes.
Accordingly, fair partial minutes were approved by Chairman, Registration Board and circulated for
implementation.
After that, complete draft minutes were distributed among the members of Registration Board
on 17th July, 2020 with the request for perusal/approval/comments (if any) within five days. None of
the members disagreed draft minutes. However, Dr. Amanullah Khan, Director, DTL, Quetta
responded for correction in the decision of Case No.07 of Post Registration-I Section, PE&R Division
as detailed under:
The comments and response is hereby tabulated for information of Board as under: -
Response of Dr. Amanullah Khan Action Taken
The case of Bayer was discussed in the meeting and it was decided a. Application was found
that the change of contract manufacturer is allowed but the contract deficient as per Form-5F
period with Nabi Qasim will be till the end of previous contract date. which was deferred for
In the recorded minutes it is mentioned that case was deferred due to submission of complete
two reasons as mentioned below documents as per Form-
5F.
a- Complete submission of document as per Form 5F. b. However, the existing
b- Existing status of validity of contract manufacturer. status of contract
manufacturer was
The case presented shows in point (i) that the firm submitted Form confirmed and the
5F with Rs.50000/- fee. decision was corrected,
accordingly.
The table of the case in column 5 shows validity of current
manufacturer till June 30, 2020.
The complete minutes in fair, along with comments and response prepared were submitted
before Chairman Registration Board for perusal/approval. The Chairman Registration Board after
perusal of comments and response approved the complete fair minutes. The same were circulated to
concerned divisions/sections for implementation.
Decision: Registration Board confirmed the minutes of 295th meeting.

Item No. II Division of Pharmaceutical Evaluation & Registration
Pharmaceutical Evaluation Cell (PEC)
Sr. No Name of Evaluator Title

1. Mr. Farooq Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Mst. Sidra Khalid Evaluator PEC-VII
8. Mst. Haleema Sharif Evaluator PEC-VIII
9. Mst. Saima Hussain Evaluator PEC-X
10. Mr. Haneef Ullah Evaluator PEC-IX
11. Mr. Farhadullah Evaluator PEC-XI
12. Mst. Mehwish Javed Khan Evaluator PEC-XIII
13. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Case No. 1: REQUIREMENT OF WHO QOS-PD TEMPLATE FOR INNOVATOR
PRODUCTS
Form 5-F (Common Technical Document) was promulgated vide S.R.O 713 (I)/2018 on 8 th June, 2018
comprising of following 5 modules:
 Module I: Administrative Part
 Module II: Overviews & Summaries
 Module III: Quality/CMC
 Module IV: Non-clinical/Safety
 Module V: Clinical/Efficacy
In Form 5-F Section 2.3 (Quality Overall Summary) of Module II bears annotation with following statement:
“QOS has been explained by a WHO QOS-PD template Module 2.3”.
In context of the above referred annotation Registration Board approved the explanatory notes for Form 5F
where in details for section 2.3 has been extracted from WHO QOS PD template.
Situation:
Many pharmaceutical firms importing innovator’s products submitted that the QOS (Quality Overall
Summary) format adopted by DRAP for the Form 5-F is based upon the WHO QOS – product
dossiers (QOS-PD) template, intended for multisource (generic) pharmaceutical products containing
APIs of synthetic or semi-synthetic origin. This format is adopted both for innovator new drugs as
well as for generic drugs by DRAP.
Since the QOS Format mentioned above is for generic version of the drugs; therefore, availability of
WHO QOS for innovator brands is not possible to be developed by the parent companies. Due to this
challenge, applications for new registration & Post Registration variations (requiring complete
dossier) of innovator brands are pending evaluation/processing. This challenge not only resulting in
depriving the patients of the benefit of new treatment options but also threatening continued
availability of registered innovator products.
To resolve the challenge, it is proposed by Pharma Bureau that “For Innovator/ New drugs (both for
Pharmaceutical & Biological drugs) DRAP may accept QOS format for the form 5-F as per ICH M4
Q (R1) guidelines”.
The ICH M4Q (R1) format for QOS is an internationally acknowledged and accepted format for filing
of NDA and our reference SRAs are practicing the same. All our dossiers of innovator drugs received
from our parent companies contains the QOS formats based on ICH M4 (R1).
COMPARISON OF WHO & ICH:
The ICH & WHO narrates similar sort of data requirement but the only difference between WHO PD template
and the ICH M4Q (R1) guidelines is that ICH guidelines only describes the requisite information while
referring to the Module 3, whereas the WHO PD template specifies the requisite information while providing
the sub-sections, tables etc. Few examples are as under:
Section 2.3.S.1 (General Information)
WHO PD template ICH M4Q (R1)
2.3.S.1.1 Nomenclature Information from 3.2.S.1 should be included.
2.3.S.1.2 Structure
2.3.S.1.3 General Properties
Section 2.3.S.4 Control of the API
2.3.S.4.1 Specification A brief summary of the justification of the
WHO PD template specifies following table for presentation specification(s), the analytical procedures, and
of information validation should be included.

Specification from 3.2.S.4.1 should be
Standard (e.g. Ph.Int., provided.
Ph.Eur., BP, USP, in-house)
Specification reference number and A tabulated summary of the batch analyses
version from 3.2.S.4.4, with graphical representation
Test Acceptance criteria Analytical procedure where appropriate, should be provided.
(Type/Source/Version)
2.3.S.4.2 Analytical Procedures

2.3.S.4.3 Validation of Analytical Procedures
2.3.S.4.4 Batch Analyses
Summary of batch analyses release results of the FPP
manufacturer for relevant batches (e.g. comparative
bioavailability or biowaiver, stability)
Test Acceptance Results
Criteria <batch x> <batch y> etc.
Description
Identification
Impurities
Assay
etc.
2.3.S.4.5 Justification of Specification

Section 2.3.P.1 Description and Composition of the FPP
The WHO template further gives breakup of requisite Information from 3.2.P.1 should be provided.
information in sub-sections and a table for the presentation of Composition from 3.2.P.1 should be provided.
composition is also given.
(a) Description of the FPP (in signed specifications):
(b) Composition of the FPP.
(c) Description of accompanying reconstitution diluent(s), if
applicable:
(d) Type of container closure system used for the FPP and
accompanying reconstitution diluent, if applicable:
Component Function Strength (label claim)
and quality
standard Quant. % Quant. % Quantity %
(and grade, per per per unit
if applicable) unit or unit or or per
per per mL
mL mL
<complete with appropriate titles e.g. Core tablet (Layer 1, Layer 2, etc.
as applicable), Contents of capsule, Powder for injection>
Subtotal 1
<complete with appropriate title e.g. Film-coating >
Subtotal 2
Total
2.3.P.3 Manufacture

2.3.P.3.1 Manufacturer Information from 3.2.P.3 should include:
2.3.P.3.2 Batch Formula Information on the manufacturer. A brief
2.3.P.3.3 Description of Manufacturing Process and Process description of the manufacturing process and
Controls the controls that are intended to result in the
2.3.P.3.4 Controls of Critical Steps and Intermediates routine and consistent production of product of
Step Controls appropriate quality. A flow diagram, as
(e.g. granulation, (parameters/limits/frequency provided under 3.2.P.3.3. A brief description
compression, coating) of testing) of the process validation and/or evaluation, as
described in 3.2.P.3.5.
2.3.P.3.5 Process Validation and/or Evaluation
PRACTICES OF VARIOUS REFERENCE REGULATORY AUTHORITIES

1. USFDA:
USFDA is accepting QOS as per the ICH M4Q guidelines for the innovator as well as generic drugs. However
FDA has recommended using question based review while developing the QOS document.
1. FDA has published a document titled “A Regulatory Perspective on the Quality Overall Summary: Putting
the Pieces Together” (accessed from https://www.fda.gov/media/110657/download on 21st August 2020).
Within this document FDA has made the following observations which are produced below:
“One approach to make the QOS more effective is the use of a question-based review (QbR) QOS for
the assessment of ANDAs,”
“In some ways, the lack of harmonization of regulatory expectations for the QOS across different
regions of the world has contributed to its underutilization as an effective application assessment tool.
Indeed, a proposal on the QOS was endorsed by the U.S. Food and Drug Administration (FDA) as a
top quality-related topic at the ICH Assembly Meeting held in June 2017.”
“It is very important to note that the QOS, in any form, does not replace or change the expected content
in Module 3.”
“While the QOS has been helpful in communicating certain quality information, there are
opportunities to improve its overall effectiveness. Indeed, one such approach to improving its
effectiveness has been the question-based review (QbR) for the Chemistry, Manufacturing, and
Controls (CMC) evaluation of ANDAs, which focuses on critical pharmaceutical quality attributes.”
“Other applicants, particularly in the new drug space, have realized the potential to improve the
effectiveness of their QOS.”
“One adaptation of the QOS has been the QbR-formatted QOS for ANDA assessment, which
applicants may continue to use for their submissions.”
“However, FDA is aware of, and is generally open to, other QOS options that are compliant with ICH
M4Q.”
“Again, it is important to note that any QOS framework will negate neither the need for a Module 3
nor the regulator’s responsibility to examine Module 3.”
2. Office of the generic drugs QbR quality overall summary outline (available at
https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/office-generic-drugs-qbr-quality-
overall-summary-outline. accessed on 25-08-2020) contains the template for QOS which is based on
question based review and is different from the ICH template. This template has endorsed certain
questions against each heading in the QOS template. But this template is generally for use in generic
drugs.
3. Example of Quality overall summary document available at FDA website for the product Ersatzine
Tablets is also based on QbD approach.
2. European Medicine Agency (EMA):
European Medicine Agency (EMA), has adopted the QOS as specified in ICH M4Q guidelines. EMA is
accepting the QOS on same format for both generic as well as innovator drugs.

3. Medicines and Healthcare products Regulatory Agency (MHRA):
Medicines and Healthcare products Regulatory Agency (MHRA), has adopted the QOS as specified in ICH
M4Q guidelines. EMA is accepting the QOS on same format for both generic as well as innovator drugs.
4. Therapeutic Goods Administration (TGA):

Therapeutic Goods Administration (TGA), has adopted the QOS as specified in ICH M4Q guidelines. EMA
is accepting the QOS on same format for both generic as well as innovator drugs.
5. Health Canada:
Quality Overall Summary - Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions)
(QOS-CE (NDS/ANDS)) document available at Health Canada website (accessed from
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-
submissions/templates/quality-overall-summary-chemical-entities-new-drug-submissions-abbreviated-
ands.html, on 21-08-2020) specifies the format for quality overall summary for both generic as well as
innovator drugs. The format specified by Health Canada is exactly similar to that of WHO QOS-PD template.
This template is recommended for both new as well as generic drugs.
6. Pharmaceuticals and Medical Devices Agency (PMDA):

Quality Overall Summary Mock P2 (Description Examples) document for Sakura Tablet available on PMDA
website specifies the QOS template for drug product part. The available template contains more specified
information as required in ICH guidelines. Although this template is not as per WHO template but still this
template has more sub headings and questions as compared to ICH document.
Proceedings:
Registration Board discussed the matter in detail and also reviewed the practices of accepting QOS template
of various reference regulatory authorities. Registration Board deliberated that WHO QOS PD template
describes the requisite information in a more precise manner, minimizing the chances of disparity between the
applicants and regulators. The same is also explained by the ICH QOS document. It was further discussed that
WHO QOS-PD template does not require any data which is not already presented in module
Decision: Keeping in view regulatory practices adopted by various reference regulatory

authorities; Registration Board decided also to accept section 2.3 Quality Overall
Summary (QOS) of Module 2 of Form 5-F (CTD) as per ICH template for the
Innovator products only. Now the applicant of innovator drug product may
submit QOS either on WHO QOS-PD template or as per ICH template.

Case No. 02: PRIORITY REGISTRATION OF REMDESIVIR CONTAINING DRUG PRODUCTS
Background:
Keeping in view the current outbreak of Covid-19, the Drug Regulatory Authority of Pakistan in its
84th meeting held on 01st June, 2020 decided as under for priority registration of Remdesivir containing drug
products:
Authority, exercising its power under Rule 26 of Drugs (LRA) Rules amended via SRO 713(I)/2018 dated 8th
June, 2018, allowed to submit registration applications on Form 5 / Form 5-A / Form 5-D instead of Form
5F, for Registration of Remdesivir and Tocilizumab in light of approvals granted by the reference regulatory
authorities and with the following additional conditions:
a. The applicants can submit their applications till 31-07-2020 and these applications will be considered out
of queue.
b. Registration Board shall consider grant of registration under proviso of Rules 29(6) (8) of the Drug
(Licensing, Registration & Advertising) Rules, 1976 and shall follow precautions / terms & conditions as
adopted by the Reference Regulatory Authorities.
c. The registration holders including those granted registration under Form 5D as a new drug will submit
data of product development and 6 months accelerated and 6 months real time stability studies data within
one year along with other data as may be required by Registration Board. The data will be considered by
Registration Board for further decision.
Consequently, Registration Board in its 295th meeting held on 8th to 11th June, 2020 granted registration of
Remdesivir (emergency use authorization) to 12 firms under section 7 of the Drugs Act, 1976 and rule 29 (6)
(8) of Drugs (Licensing, Registering and Advertising) Rules, 1976 with same precautions/ terms and conditions
as adopted by Reference Regulatory Authorities.
In this regard, Registration Board also specified following condition among a number of other conditions
subject to which the registrations were approved:
“Firm will report monthly to National Pharmacovigilance Centre, Pharmacy Services Division DRAP,
serious adverse events and all medication errors associated with the use of the authorized Remdesivir that
are reported to the firm during the pandemic.”
Pharmacy Services Division was accordingly requested to collect & compile data regarding serious adverse
events and all medication errors associated with the use of Remdesivir from all firms which have been granted
registration of Remdesivir (emergency use authorization) for consideration by the Registration Board in its
296th meeting of Registration Board, scheduled on 08th September, 2020.
In response, Pharmacy Services Division has informed (vide letters dated 11-08-2020 & 21-08-2020) that
following firms have been directed to comply with the above mentioned decision of Registration Board. The
firms have also been advised to make a proper pharmacovigilance system in their organization by upgrading
and strengthening the procedures of collection and monitoring of adverse drug reactions from patients and
healthcare professionals.
1. M/s BF Biosciences Ltd (Nil report from 1st to 26th August, 2020)
2. M/s Bio Labs Pvt Ltd. (Nil Report in July and August 2020)
3. M/s Allmed Pvt Ltd. (Not marketing)
4. M/s Nabiqasim Industries Pvt Ltd. (Nil Report from July to August, 2020)
5. M/s Bosch Pharmaceuticals (Pvt.) Ltd. (1st July to 1st September, 2020)
6. M/s Sami Pharmaceuticals (Pvt) Limited (Nil Report for August, 2020)
7. M/s Macter International Limited (under manufacturing not yet marketing)
8. M/s Hilton Pharma Pvt Ltd. (not yet Marketing)
9. M/s. Winsfeild Pharmaceuticals (Nil Report August, 2020)
10. M/s The Searle Company Limited (Nil report August, 2020)
11. M/s OBS Healthcare (Pvt) Limited, (Nil Report June, 2020)
Current Situation
Registration Board was apprised of the decision of Authority taken in its 91 st meeting held
th
on 4 September, 2020 regarding registration of Remdesivir containing drug products as under:
“The Authority keeping in view the status of emergency use authorization of Remdesivir in reference regulatory
authorities, prevailing situation of COVID-19 and for preparedness of any emergency situation in the country, advised
the Registration Board to proceed in the matter on following analogies:
I. Consider new registration applications of Remdesivir after submission of following:
i. Product development data and 3 months accelerated and real time stability studies data for zone IV-A
ii. Protocols of Pharmacovigilance data submission duly endorsed by Pharmacy Services Division.
II. For already granted registrations for emergency use authorization, firms shall be advised to submit:
i. Product development data and 3 months accelerated and real time stability studies data for zone IV-A
ii. Protocols of Pharmacovigilance data submission duly endorsed by Pharmacy Services Division within two
weeks.
III. Registrations of emergency use authorizations of Remdesivir, not complying with above conditions will be
suspended till the submission of requisite data and approval by Registration Board.
The Authority further decided not to extend the exemption date under SRO 713(I)/2018.”
The Board deliberated upon the above cited decision of the Authority and decided as under for further
processing of the Registration applications of Remdesivir containing drug products.
 All new registration applications of Remdesivir will be considered upon submission of following:
i. Product development data and 3 months accelerated and real time stability studies data for Zone IV-A
 For already granted registrations for emergency use authorization, firms shall be advised to submit:
ii. Protocols of Pharmacovigilance data submission duly endorsed by Pharmacy Services Division within two
weeks.
 Registrations of emergency use authorizations of Remdesivir, not complying with above conditions will be
suspended till submission of requisite data and approval by Registration Board.
Proceedings & Decision:
As requisite data has not been submitted by any of the applicant, thus Registration Board decided to defer
following applications for "Remdesivir" for submission of following data:
I. Applications of Local manufacturing:
1. Name and address of Manufacturer / M/s Welwrd Pharmaceuticals.Plot # 3, Block A, Phase I-II,
Applicant Industrial Estate Hattar, KPK
Brand Name+DosageForm+Strength Remvir 5mg/ml Injection
Composition Each Vial (20ml) contains :
Remdesivir ….. 100mg
Diary No. Date of R&I & fee Dy. No.13116; 09-06-2020 ; Rs.50,000
Pharmacological Group Anti-Viral
Type of Form Form 5D
Finished Product Specification Innovator’s Specs
Pack Size & Demanded Price As per SRO
2. Name and address of Manufacturer / M/s Welmark Pharmaceuticals. Plot #122 Phase 5, Block B,
Applicant Hattar
Brand Name+DosageForm+Strength Remvid Lyophilized Powder for Injection 100mg
Composition Each Vial contains:
Remdesivir Lyophilized Sterile Powder ….. 100mg
Finished Product Specification Manufacturer’s Specs
3. Name and address of Manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd. 19 Km Sheikhupura
Applicant Road, Faislabad
Brand Name+DosageForm+Strength Remdisil Liquid Solution for Infusion
Composition Each 20ml vial contains:
Remdesivir…100mg

4. Name and address of Manufacturer / M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Applicant Road, Islamabad
Brand Name+DosageForm+Strength Biovir Injection 5mg/ml
Type of Form Form 5
5. Name and address of Manufacturer / M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial Estate, Kot
Applicant Lakhpat, Lahore
Brand Name+DosageForm+Strength Remi Injectable Solution 100mg/ml
6. Name and address of Manufacturer / M/s Shaigan Pharmaceuticals (Pvt) Ltd, 14 KM Adyala Raod
Applicant Post Office Daghal, Rawalpindi
Brand Name+DosageForm+Strength Redesvir 100 Injection
Composition Each Lyophilized vial contains :
7. Name and address of Manufacturer / M/s Shaigan Pharmaceuticals (Pvt) Ltd, 14 KM Adyala Raod
Applicant Post Office Daghal, Rawalpindi
Brand Name+DosageForm+Strength Redesvir Liquid solution for Injection 5mg/ml
8. Name and address of Manufacturer / M/s Searle IV Solutions Pvt Ltd. 1.5 km, Manga Raiwind Road,
Applicant Lahore
Brand Name+DosageForm+Strength Macdevir 100mg/20ml Liquid Injection
9. Name and address of Manufacturer / M/s Barrett Hodgson Pakistan Pvt Ltd. F/423, SITE, Karachi
Applicant
Brand Name+DosageForm+Strength Remitec Injection 100mg/20ml

10. Name and address of Manufacturer / M/s Treat Pharmaceutical Industry Pvt Ltd. A-37, Small
Applicant Industrial Estate, Township Kohat Road, Bannu
Brand Name+DosageForm+Strength Tamcor 100mg/2ml Liquid solution for Infusion
Type of Form Form 5
11. Name and address of Manufacturer / M/s Brookes Pharma Pvt Ltd. 58 & 59, Sector 15, Korangi
Applicant Industrial Area, Karachi
Brand Name+DosageForm+Strength Remidi concentrated solution for infusion 5mg/ml
Composition Each ml contains :
Type of Form Form 5
12. Name and address of Manufacturer / M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km,Ferozepur
Applicant Road, Lahore
Brand Name+DosageForm+Strength Remvir Injection 5mg/ml
13. Name and address of Manufacturer / M/s S.J & G Fazul Ellahie Pvt Ltd. E-46, S.I.T.E. Karachi-75700
Applicant
Brand Name+DosageForm+Strength Remiv Injection 100mg
Composition Each lyophilized Vial (20ml) contains :
14. Name and address of Manufacturer / M/s Neutro Pharma (Pvt) Ltd. 9.5 km, Sheikhupura Road,
Applicant Lahore
Brand Name+DosageForm+Strength Medvir-19 Injection 100mg/2ml

15. Name and address of Manufacturer / M/s Neutro Pharma (Pvt) Ltd. 9.5 km, Sheikhupura Road,
Applicant Lahore
Brand Name+DosageForm+Strength Medvir-19 Injection 100mg/2ml
Composition Each Vial contains :
Remdesivir lyophilized powder eq to Remdisvir ….. 100mg
16. Name and address of Manufacturer / M/s Shrooq Pharmaceuticals Pvt Ltd. 21-km Ferozpur Road,
Applicant Lahore, Pakistan
Brand Name+DosageForm+Strength Remsivir Injection 100mg/2ml
Type of Form Form 5
17. Name and address of Manufacturer / M/s Zafa Pharmaceuticals Laboratories Private Limited. L1/B
Applicant Block-22, Federal B industrial Area, Karachi
Brand Name+DosageForm+Strength Covizaf Concentrated solution for infusion 100mg/20ml
18. Name and address of Manufacturer / M/s Medisave Pharmaceuticals. Plot 578-579, Sundar Industrial
Applicant Estate, Lahore, Pakistan
Brand Name+DosageForm+Strength Remdisave 5mg/ml Infusion
Type of Form Form 5
19. Name and address of Manufacturer / M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Applicant Karachi, 75190, Pakistan
Brand Name+DosageForm+Strength Remvir 100mg/20ml Injection
20. Name and address of Manufacturer / M/s English Pharmaceuticals Industries. Link Kattar Bund Road,
Applicant Thokar Niaz Baig, Multan Road, Lahore
Brand Name+DosageForm+Strength Codesvir 100mg/20ml Injection

Type of Form Form 5
21. Name and address of Manufacturer / M/s Tabros Pharma Pvt Ltd. L-20/B,Sector-22, Federal B
Brand Name+DosageForm+Strength Remz Injection 100mg
22. Name and address of Manufacturer / M/s Medisure Laboratories Pakistan Pvt Ltd. A-115, S.I.T.E,
Applicant Super Highway, Karachi, Pakistan
Brand Name+DosageForm+Strength Remdesivir 100mg/20ml Injection
Type of Form Form 5
23. Name and address of Manufacturer / M/s Hamaz Pharmaceuticals Pvt Ltd. Business City Plaza, Hall
Applicant # 1, 2nd Floor, Bosan Road, Multan, Pakistan
Brand Name+DosageForm+Strength Covirid Concetrated solution for infusion 100mg
Type of Form Form 5
24. Name and address of Manufacturer / M/s GT Pharma Pvt Ltd. Plot No. 713, Sundar Industrial Estate,
Applicant Lahore
Brand Name+DosageForm+Strength Remend Concentrated for Solution for Infusion
Remdesivir …100mg
Pack Size & Demanded Price As Per SRO
25. Name and address of Manufacturer / M/s Safe Pharmaceuticals Pvt Ltd. Plot No. C.I-20, Sector 6-B,
Applicant Industrial Area, North Karachi
Brand Name+DosageForm+Strength Saferemid Injection 100mg/20ml
Type of Form Form 5

26. Name and address of Manufacturer / M/s Friends Pharma Pvt Ltd. 31-km, Ferozepur Road, Lahore,
Applicant Pakistan
Brand Name+DosageForm+Strength Simdesivir Injection 100mg
Composition Each Lyophilized Vial Contains :
Finished Product Specification
27. Name and address of Manufacturer / M/s Friends Pharma Pvt Ltd.31-km, Ferozepur Road, Lahore,
Applicant Pakistan
Brand Name+DosageForm+Strength Simdesivir Solution for Injection 100mg/20ml
28. Name and address of Manufacturer / M/s Bosch Pharmaceuticals Pvt Ltd. Plot No. 209, Sector 23,
Applicant Korangi Industrial Area, Karachi, Pakistan
Brand Name+DosageForm+Strength Remivir 100mg/20ml Liquid Injectable
Type of Form Form 5
29. Name and address of Manufacturer / M/s Bosch Pharmaceuticals (Pvt.) Ltd. Bosch House 221, Sector
Applicant 23, Korangi Industrial Area, Karachi, Pakistan
Brand Name+DosageForm+Strength Besivir 100mg/20ml Liquid Injectable
Type of Form Form 5
30. Name and address of Manufacturer / M/s Macter International Limited. F-216, S.I.T.E, Karachi,
Applicant Pakistan
Brand Name+DosageForm+Strength Rememac 100mg/20ml Lyophilized for Injection
31. Name and address of Manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial Estate,
Applicant Raiwind Road, Lahore
Brand Name+DosageForm+Strength Remdisol Injection 5mg/ml
Remdesivir …100mg

Finished Product Specification Pharmasol’s Specs
32. Name and address of Manufacturer / M/s EG Pharmaceuticals. Plot. No. 13-A, Industrial Triangle,
Applicant Kahuta Road, Islamabad
Brand Name+DosageForm+Strength Remedy Injection 100mg/20ml
Composition Each 20ml Vial contains :
Remdesivir …100mg
Type of Form Form 5A
Finished Product Specification EG Specs
33. Name and address of Manufacturer / M/s Hygeia Pharmaceuticals. Plot No. 295, Industrial Triangle,
Brand Name+DosageForm+Strength Hydesivir Injection 100mg/20ml
Remdesivir …100mg
Type of Form Form 5
Finished Product Specification Hygeia Specs
34. Name and address of Manufacturer / M/s Mediceena Pharma. 27 Km, Raiwind Road, Lahore,
Applicant Pakistan
Brand Name+DosageForm+Strength Remdicina Lyophilized Powder for Infusion
Composition Each Lyophilized Vial contains :
Remdesivir …100mg
Pharmacological Group Investigational
Pack Size & Demanded Price As Per Pricing Policy
35. Name and address of Manufacturer / M/s Biogen Pharma. 8-Km, Chakbeli Road, Rawat, Rawalpindi,
Applicant Pakistan
Brand Name+DosageForm+Strength Desvir 100mg/20ml Solution for Injection
Composition Each Vial(20ml) contains :
Remdesivir …100mg
36. Name and address of Manufacturer / M/s Biogen Pharma. 8-Km, Chakbeli Road, Rawat, Rawalpindi,
Applicant Pakistan
Brand Name+DosageForm+Strength Genvir 100mg Injection I.V
Remdesivir …100mg

37. Name and address of Manufacturer / M/s Liven Pharmaceuticals Pvt Ltd. 49 km, Lahore Multan
Applicant Road.
Brand Name+DosageForm+Strength Remvir 100mg/20ml Injection
Remdesivir …100mg
38. Name and address of Manufacturer / M/s Lawrence Pharma Pvt. Ltd. 10.5 Km, Sheikhupura Road,
Applicant Lahore
Brand Name+DosageForm+Strength Lemdesivir Injection
Composition Each 1ml contains :
Remdesivir …5mg
Type of Form Form 5
39. Name and address of Manufacturer / M/s Cunningham Pharmaceuticals Pvt Ltd. Plot # 81, Sunder
Applicant Industrial Estate, Raiwind Road Lahore, Pakistan
Brand Name+DosageForm+Strength Romafer 100mg/20ml IV Injection for Soultion
Remdesivir…5mg
Type of Form Form 5
Pack Size & Demanded Price As Per DRAP Policy
40. Name and address of Manufacturer / M/s Inventor Pharma. Plot No. K/196, S.I.T.E. (SHW) Phase II,
Applicant Karachi
Brand Name+DosageForm+Strength Remitor Injection
Remdesivir…100mg
Pack Size & Demanded Price As Per DRAP Pricing Policy
41. Name and address of Manufacturer / M/s Star Laboratories Pvt Ltd. 23-km, Multan Road, Lahore
Applicant
Brand Name+DosageForm+Strength Remdi Injection
Remdesivir…5mg
42. Name and address of Manufacturer / M/s Trigon Pharmaceuticals Pvt Limited. 8 km, Thoker Raiwind
Brand Name+DosageForm+Strength Desmer 100mg/20ml Injection
Remdesivir…100mg/20ml

Type of Form Form 5
Finished Product Specification Trigon Specifications
43. Name and address of Manufacturer / M/s Zafa Pharmaceuticals Laboratories Private Limited.
Applicant L-1/B, Block-22, Federal B industrial Area, Karachi
Brand Name+DosageForm+Strength Covizaf Lyophillized Powder for Injection 100mg
Remdesivir Lyophilized Powder for Injection …100mg
Pack Size & Demanded Price As Per PRC
44. Name and address of Manufacturer / M/s Indus Pharma (Pvt.) Ltd. Plot No. 26,27 & 63-67, Sector 27,
Applicant Korangi Industrial Area, Karachi
Brand Name+DosageForm+Strength Indorem 5mg/ml Injection
Remdesivir…5mg
45. Name and address of Manufacturer / M/s Venus Pharma. 23 km, Multan Road, Lahore
Applicant
Brand Name+DosageForm+Strength DV-Rem 100mg/20ml Injectable Solution
Remdesivir…100mg
Type of Form Form 5
Finished Product Specification Innovator’s Specifications
II. Applications of local manufacturing by way of contract manufacture:

46. Name and address of Manufacturer / M/s CCL Pharmaceuticals Pvt Ltd. 62 Industrial Estate,Kot
By: M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Area, Karachi, Pakistan
Brand Name+DosageForm+Strength Remi Lyophilized Powder for Injection
47. Name and address of Manufacturer / M/s Indus Pharma (Pvt.) Ltd. Plot No. 26,27 & 63-67, Sector 27,
Applicant Korangi Industrial Area, Karachi
By: M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Area, Karachi, Pakistan
Brand Name+DosageForm+Strength IIndorem 100mg Injection
Remdesivir…100mg
th
Minutes of 296 Meeting of Registration Board | 18
48. Name and address of Manufacturer / M/s Welmark Pharmaceuticals. Plot #122 Phase 5, Block B,
Applicant Hattar
By
M/s Welwrd Pharmaceuticals. Plot # 3, Block A, Phase I-II,
Industrial Estate Hattar, KPK
Brand Name+DosageForm+Strength Remedi Injection 5mg/ml
49. Name and address of Manufacturer / M/s Moringa Pharmaceuticals. 35-A, Sunder Industrial Estate,
Applicant Lahore
By
M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Road, Islamabad
Brand Name+DosageForm+Strength Remdesivir Injection 5mg/ml
Remdesivir …100mg
Type of Form Form 5
Finished Product Specification Bio Lab’s Specifications
Pack Size & Demanded Price As Recommended by PRC
50. Name and address of Manufacturer / M/s Genetics Pharmaceuticals Pvt. Ltd. 539-A, Sundar Industrial
Applicant Estate,Raiwind,Lahore
By: M/s Allmed Pvt Ltd. Plot No. 590, Sundar Industrial Estate,
Lahore, Pakistan
Brand Name+DosageForm+Strength Genvir 5mg/ml Concentrated Solution for Infusion
Remdesivir …100mg
Pack Size & Demanded Price As Per relevent SRO
III. Applications of Import:
51. Name and address of Manufacturer / M/s Ferozsons Laboratories Ltd.
Applicant P.O Ferozsons, Amangarh, Nowshera-Khyber Pakhtunkhwa
By: M/s Hetero Labs Limited. 7-2-A2, Hetero Corporate,
Industrial Estates, Sanath Nagar, Hyderabad-500018, Telangana,
India
Brand Name+DosageForm+Strength Civifor 100mg Lyophilized Powder for Concentrate for Solution
for Infusion
Remdesivir …100mg

52. Name and address of Manufacturer / M/s AGP Limited. B-23-C, S.I.T.E. Karachi
Applicant By: M/s Mylan Laboratories Limited. No. 19-A, Plot No. 284/B1
Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk
Banglore- 560 105, India
Brand Name+DosageForm+Strength Desrem Lyophilized Powder for Infusion
Remdesivir …100mg
Pack Size & Demanded Price As Per approved SRO/ MRP: Rs. 10,873/-
53. Name and address of Manufacturer / M/s Pharmatec Pakistan Pvt Ltd. D-86/A, S.I.T.E. Karachi-75700
Applicant By: M/s Healthcare Pharmaceutical Ltd. Gazariapara,
Rajendrapur, Gazipur-1703, Bangladesh
Brand Name+DosageForm+Strength Remdevir Injection 100mg
Remdesivir …100mg
54. Name and address of Manufacturer / M/s Getz Pharma Pvt Ltd. 29-30/27, Korangi Industrial Area,
Applicant Karachi.
By: M/s Eskayef Pharmaceutical Ltd. 400 Squibb Road, Tongi
Industrial Area, Tongi, Gazipur 1711, Bangladesh
Brand Name+DosageForm+Strength Remivir 100mg Lyophilized Powder for Injection
Remdesivir …100mg
Pack Size & Demanded Price As fixed by DPC
55. Name and address of Manufacturer / M/s Himmel Pharmaceuticals Pvt Ltd.
Applicant 793-D Block C, Faisal Town, Lahore, Pakistan
By: M/s Beacon Pharmaceuticals Limited.Kathali, Bhaluka,
Mymensingh, Bangladesh
Brand Name+DosageForm+Strength Pandovir 100 IV Injection
Composition Each vial Lyophilized powder for solution for infusion contains :
56. Name and address of Manufacturer / M/s Adamjee Pharmaceuticals Pvt Ltd.
Applicant Plot 39, Sector 15, Korangi Industrial Area, Karachi
By: M/s Safe Pharmaceuticals Pvt Ltd.
Plot No. C.I-20, Sector 6-B, Industrial Area, North Karachi
Brand Name+DosageForm+Strength Adremid Injection 100mg/20ml
Remdesivir …….. 100mg
Type of Form Form 5
57. Name and address of Manufacturer M/s AJM Pharma. Plot No. 44, Sector No. 27, Korangi Industrial
Applicant Area, Karachi, Pakistan
By: M/s Eva Pharma of Pharmaceuticals and Medical Appliances.
Kafr El Gabal, El Haram, Giza, Egypt
Brand Name+DosageForm+Strength Ajvir 100mg/20ml Concentrate for solution for IV Infusion
Remdesivir …100mg
 For already granted registrations for emergency use authorization, firms shall be advised to submit:
i. Product development data and 3 months accelerated & real time stability studies data for Zone IV-A.
ii. Protocols of Pharmacovigilance data submission duly endorsed by Pharmacy Services Division within
two weeks.
Registrations of emergency use authorizations of Remdesivir, not complying with above conditions will be
suspended till the submission of requisite data and approval by Registration Board.

Item No. I: Agenda of Evaluator PEC-VI
Case No. 01 Registration applications for local manufacturing of (Human) drugs
a. New cases
58. Name and address of manufacturer / M/s Palpex Pharmaceuticals Pvt Ltd, Plot # FD-46-A-8, Street-I
Applicant Sector-38, Korangi Creek Industrial Park, Karachi Pakistan
Contract Manufacturing from M/s Nicholas Pharmaceuticals, Plot
# 34, St. # SS-02, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Ncopenem 500mg Injection (IV)
Composition Each Vial Contains:
Meropenem as Trihydrate Blended with Anhydrous Sodium
Carbonate (Sterial)…500mg
Diary No. Date of R& I & fee Dy.No 44463 dated 31-12-2018 Rs.50,000/-
Pharmacological Group Carbapenem
Type of Form From-5
Finished product Specification USP
Pack size & Demanded Price As per SRO, As per SRO
Approval status of product in Reference Meropenem 500 mg Powder for Solution for Injection
Regulatory Authorities. or Infusion by M/s Hospira UK Limited (MHRA Approved)
Me-too status Meronem by ICI Pakistan (Reg. No. 018543),
GMP status cGMP certificate issued based on the evaluation conducted on
28-1-2020.
Remarks of the Evaluator.(VI) The firm has carbapenem section according to the cGMP
certificate. M/s Palpex Pharmaceutical has not previously
applied product for contract manufacturing and it has 7 sections.
Decision: Deferred for capacity assessment of Nicholas Pharmaceuticals.
Contract Manufacturing from M/s Nicholas Pharmaceuticals, Plot
# 34, St. # SS-02, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Ncopenem 1g Injection (IV)
Meropenem as Trihydrate Blended with Anhydrous Sodium
Carbonate (Sterial)…1gm
Type of Form From-5
Approval status of product in Reference Meronem 1g by M/s Pfizer Limited (MHRA Approved)
Regulatory Authorities.
Me-too status Meronem by ICI Pakistan (Reg. No. 018548)
GMP status cGMP certificate issued based on the evaluation conducted on 28-
1-2020.
certificate. M/s Palpex Pharmaceutical has not previously applied
product for contract manufacturing and it has 7 sections.
Contract Manufacturing from M/s Nicholas Pharmaceuticals,
Plot # 34, St. # SS-02, National Industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Strength Ertapem 1g Injection (IV)
Ertapenem sodium eq to ertapenem….1gm
Type of Form Form-5
Finished product Specification Mfg
Approval status of product in Reference MHRA approved; ERTAPENEM 1G POWDER FOR
Regulatory Authorities. CONCENTRATE FOR SOLUTION FOR INFUSION
Me-too status Invanz by Muller & Phipps (Reg. No. 043051)
28-1-2020.
Islamabad
Brand Name +Dosage Form + Strength Cilasten 250mg Injection (IV)
Imipenem ………………..250mg
Cilastatin sodium eq to cilastatin….250mg
Type of Form Form-5
Approval status of product in Reference Imipenem/Cilastatin 250mg/250mg Powder for
Regulatory Authorities. Solution for Infusion by M/s Actavis Group PTC ehf
(MHRA Approved)
Me-too status Cilapen by Bosch (Reg No. 048490)
28-1-2020.
Islamabad
Brand Name +Dosage Form + Strength Cilasten 500mg Injection (IV)
Imipenem …..500mg
Cilastatin sodium eq to cilastatin….500mg
Type of Form Form-5
Approval status of product in Reference Imipenem/Cilastatin 500 mg/500 mg, powder for solution
Regulatory Authorities. for infusion b M/s Fresenius Kabi Ltd (MHRA Approved)
Me-too status Primaxin by Stallion (Reg No. 080839)
28-1-2020.

63. Name and address of manufacturer / M/s Medley Pharmaceuticals 41-A, PSIE Jhang Bahatar Road,
Applicant Wah Cantt
Contract manufacturing from
M/s Medpharm Research Lab. 28 km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Medpectam Injection 500mg
Cefoperazone Sodium…250mg
Sulbactam Sodium…250mg
Diary No. Date of R& I & fee Dy.No 15925 dated 07-03-2019 Rs.50,000/- 06-03-2019
Pharmacological Group Cephlosporins
Type of Form Form-5
Finished product Specification JP
Approval status of product in Reference PMDA Japan Approved
Me-too status 2Sum Injection 500mg of M/s Sami Pharmaceuticals,
Karachi (Reg.# 079941)
GMP status M/s Medpharm research Lab Lahore:- Panel inspection for
renewal of DML dated 22-1-2018Overall evaluation of
inspection report is good
Remarks of the Evaluator.(VI) Medpharm has dry powder injection (Cephalosporin) section
Decision: Deferred for consideration on its turn according to the queue.
Applicant Wah Cantt
Contract manufacturing from M/s Medpharm Research Lab.28
km, Ferozepur Road, Lahore
Sulbactam Sodium…500mg
Type of Form Form-5
Approval status of product in Reference Sulperazon Injection by Pfizer Inc. PMDA Approved
Me-too status Ectafin Injection 1gm IV by Hi-Medic Pharmaceuticals (Pvt)
Ltd. Reg. No. 80028
Applicant Wah Cantt
Sulbactam Sodium……..1000mg
Type of Form Form-5
Approval status of product in Reference Approved in 03 European countries, i.e., Czech Republic,
Regulatory Authorities. Poland and Slovakia
Me-too status Ectafin Injection 2gm IV by Hi-Medic Pharmaceuticals (Pvt)
Ltd. Reg. No. 80027
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medixime DS 100mg/5ml suspension
Composition Each 5ml contains:
Cefixime as Trihydrate…100mg
Type of Form Form-5
Approval status of product in Reference USFDA Approved
Me-too status Stlicef Dry Suspension 100mg/5ml of Treat Pharma
Remarks of the Evaluator.(VI) Medpharm has dry powder injection and suspension
(Cephalosporin) section
Applicant Wah Cantt
Contract manufacturing from M/s Medpharm Research Lab.
28 km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Medixime DS 200mg/5ml suspension
Type of Form Form-5
Me-too status Stlicef Dry Suspension 200mg/5ml of Treat Pharma
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medixime Capsule 400mg
Composition Each capsule contains:
Cefixime Trihydrate…400mg
Type of Form Form-5
Me-too status Spanix Capsule by Neomedix Pharma
Remarks of the Evaluator.(VI) Medpharm has dry powder injection and suspension, capsule
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medipim Injection 1000mg
Cefepime as Hcl …1000mg
Type of Form Form-5
Me-too status Nuxipim 1g Injection of Bosch
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medipim Injection 500mg
Cefepime as Hcl …500mg
Type of Form Form-5
Me-too status Nuxipim 500mg Injection of Bosch

Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medadin Injection 500mg
Ceftazidime as pentahydrate…500mg
Type of Form Form-5
Approval status of product in Reference MHRA Approved
Me-too status Ceftaz by Pharmedic
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medadin Injection 250mg
Ceftazidime as pentahydrate…250mg
Type of Form Form-5
Me-too status Ceftaz by Pharmedic
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medodoxime DS 50mg/5ml suspension
Cefpodoxime as Proxetil…50mg
Type of Form Form-5
Me-too status Qink Dry Suspension of M/s Wilshire Laboratories
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Medodoxime DS 100mg/5ml suspension
Cefpodoxime as Proxetil…100mg
Type of Form Form-5
Applicant Wah Cantt
Brand Name +Dosage Form + Strength Cefamed Injection 250mg IM
Ceftriaxone as Sodium…250mg
Type of Form Form-5
Me-too status Unixone Injection (ceftriaxone Sodium) 250mg IM by Caliph
Pharmaceuticals (Pvt.) Ltd. Reg. No. 82556

b. Deferred cases
76. Name and address of manufacturer / M/s Biogen Pharma.
Applicant 8-Km, Chakbeli Road, Rawat, Rawalpindi, Pakistan
Brand Name +Dosage Form + Strength Velanef 800mg Tablets
Composition Each Film Coated Tablet Contains:
Sevelamer HCL…800mg
Pharmacological Group Phosphate Binder
Type of Form Form 5
Pack size & Demanded Price 30’s, As per SRO
Approval status of product in Reference Renagel 800mg Tablet by M/s Genzyme Corporation,
Regulatory Authorities. (USFDA approved)
Me-too status Renavel 800mg Tablet by M/s AllianzeMed
Pharmaceuticals (Reg No:075510)
GMP status 26-10-2018. The firm is not found working as required
under the law/rule
Remarks of the Evaluator. (VI)
Previous Decision Decision of 293rd: Deferred for updated GMP status of the firm
from QA&LT Division.
Evaluation by PEC:
The firm has submitted panel inspection report dated 25-11-2019, the panel recommended for the renewal of
DML.
Decision: Approved with innovator’s specification
77. Name and address of manufacturer / "M/s Pharmedic Laboratories Pvt Ltd.
Applicant 16-km, Multan Road Lahore, Pakistan"
Brand Name +Dosage Form + Strength Flostin Tablets
Composition Each film coated tablet contains:
Fluoxetine as HCl….10mg
Pharmacological Group Selective serotonin reuptake inhibitors
N06AB03
Type of Form Form 5
Pack size & Demanded Price 2,10,20,30 PVC Alu Blister.
Me-too status 044602; "Futine 10 mg Tab.
"M/s Wilshire Laboratories, 124/A, Kotlakhpat, Indus. Area,
Township Scheme, Lahore.
GMP status 24-06-2019 Decision of the 270th Meeting of CLB:
The board after detailed discussion on the investigation report of
FID dated 13-05-2019, in the compliance to 267th meeting of
CLB, decided to issue show cause notice to the following accused
persons and give them opportunity of personal hearing n the next
meeting of CLB on the matter of unauthorized manufacturing in
the Liquid Injection Section (General).
I- M/s Pharmedic Laboratories Pvt Ltd, Lahore through its CEO.
II- Management of M/s Pharmedic Laboratories Lahore as per
Form-29 of SECP.
i- Mr Waqar A Sheikh CNIC No 35202-9152354-3
ii- Mr Adeel A Sheikh CNIC No 35202-9143709-3
III- Mr Muhammad Nouman Ahmed, Quality Control Incharge
S/O Muhammad Anwar ul Haq, CNIC No. 35202-2745122-9
IV- Mr Jamshaid Ghani, Production Incharge S/O Abdul Ghani,
CNIC No 54400-0548981-5
Remarks of the Evaluator. (VI) Justification for 3% overage.
Decision of 291st : Registration Board referred the case to QA & LT Division for updated GMP status of the
firm.
Evaluation by PEC:The firm has submitted panel Inspection report dated 4-2-2020 satisfactory level of GMP
compliance.
Decision:Deferred for justification of overage in master formulation.
Brand Name +Dosage Form + Strength Biofol Dry Suspension
Iron as Iron III hydroxide polymaltose complex… 50mg
Folic Acid…0.43mg
Pharmacological Group Anti-anemic
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 60 ml amber color, as per SRO.
Approval status of product in Reference Could not be confirmed.
Me-too status 042952; Hemoplex-F Syrup
M/s Synchro Pharmaceuticals, Kot Lakhpat, Lahore
GMP status 24-06-2019:
Decision of the 270th Meeting of CLB:
The board after detailed discussion on the investigation report of
FID dated 13-05-2019, in the compliance to 267th meeting of
CLB, decided to issue show cause notice to the following accused
persons and give them opportunity of personal hearing in the next
meeting of CLB on the matter of unauthorized manufacturing in
the Liquid Injection Section (General).
I- M/s Pharmedic Laboratories Pvt Ltd, Lahore through its CEO.
II- Management of M/s Pharmedic Laboratories Lahore as per
Form-29 of SECP
i- Mr Waqar A Sheikh CNIC No 35202-9152354-3
ii- Mr Adeel A Sheikh CNIC No 35202-9143709-3
III- Mr Muhammad Nouman Ahmed, Quality Control Incharge
S/O Muhammad Anwar ul Haq, CNIC No. 35202-2745122-9
IV- Mr Jamshaid Ghani, Production Incharge S/O Abdul Ghani,
CNIC No 54400-0548981-5
Remarks of the Evaluator. (VI) Evidence of international availability.
Section approval certificate
Me-too is not confirmed
st
Decision of 291 : Registration Board referred the case to QA & LT Division for updated GMP status of the
firm.
Evaluation by PEC: The firm has submitted panel Inspection report dated 4-2-2020 satisfactory level of
GMP compliance.
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 as referred generic liquid
syrup and instant product is dry powder suspension.
Diary No. Date of R& I & fee Dy. No. 134: 22-7-2015, PKR 20, 000/-: 22-07-2015
Brand Name +Dosage Form + Strength Lycain 1% Injection
Composition Each 5ml ampoule contains:
Lidocaine hydrochloride……. 50mg
Pharmacological Group Local anesthetic
Type of Form Form 5

Pack size & Demanded Price 5’s: Rs. 12/ampoule
Approval status of product in Reference Lidocaine 1% injection by Accord Healthcare
Regulatory Authorities. (MHRA Approved)
Me-too status Lidocaine injection by Tabros
GMP status Last inspection report dated 31-08-2016 confirms satisfactory
compliance to GMP
Remarks of the Evaluator. Firm has initially applied for 35mg/3.5ml injection and later
changed the composition to 50mg/5ml since the formulation was
not approved by any reference regulatory authority.
Decision of 273rd Deferred for submission of fee Rs. 20,000/-
since the firm has changed the formulation from 35mg/5ml to
50mg/5ml injection.
Firm has submitted the required fee Dated 24-10-2017.
Decision of 277th: Registration Board deferred the case for submission of latest GMP inspection report
conducted within last one year. Board further directed to send a reference to QA & LT Division to conduct
GMP inspection of Firm on priority.
Evaluation by PEC(VI): The firm has submitted panel Inspection report dated 04-02-2020 showing
satisfactory level of GMP compliance.
Decision: Approved.
80. Name and address of manufacturer / M/s Hicon Pharmaceuticals.
Applicant 131-Industrial Estate, Hayatbad
Diary No. Date of R& I & fee Dy.No 34703 dated 18-10-2018 Rs.20,000/- Dated 18-10-2018
Brand Name +Dosage Form + Strength Gastrocon Suspesnion
Composition Each 10ml Contains:
Sodium Alginate…500mg
Sodium Bicarbonate…267mg
Pharmacological Group A02BX, Drugs for pepti ulcer and GERD disease.
Type of Form Form 5
Pack size & Demanded Price 120ml, As per SRO
Approval status of product in Reference Could not be confirmed
Me-too status Could not be confirmed
GMP status 26-7-2018, firm is operating at good level of GMP compliance.
Remarks of the Evaluator. Product in RRA and me-too could not be confirmed.
rd
Decision of 293 : 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
declared/approved by the Registration Board
Evaluation by PEC(VI): The firm has submitted a reference from ANSM of Gaviscon Oral suspension in a
bottle and me too status as N-Tasid 500mg/267mg liquid of GETZ pharma Reg no 044339.
Decision: Deferred for confirmation of me-too / generic for applied formulation.
81. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd. 19 Km Sheikhupura Road,
Applicant Faislabad
Contract manufacturing By M/s Novamed Pharmaceuticals (Pvt)
Ltd. 28-km,Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength DualCef 2gm IV/IM Injection
Sterile Powder of Cefoperazone Sodium Eq. to
Cefoperazone…1gm
Sterile Powder of Sulbactam Sodium Eq. to
Sulbactum…1gm
Pharmacological Group Cephalosporins
Type of Form Form 5
Approval status of product in Reference Approved in 03 European countries, i.e., Czech
Regulatory Authorities. Republic, Poland and Slovakia
Me-too status Ectafin Injection 2gm IV by Hi-Medic Pharmaceuticals
(Pvt) Ltd. Reg. No. 80027
GMP status NovaMed: 5th and 27th December 2017, Firm is compliant to good
cGMP guidelines. Firm has Cephalosporin injectable section
according to this report.
Remarks of the Evaluator. The firm M/s Saffron Pharmaceuticals, Faisalabad has 5 products
already on contract manufacturing.
Decision of 293rd :
Registration Board decided to defer for assessment of manufacturing and quality
control capacity of M/s Novamed Pharmaceuticals (Pvt.) Ltd. 28-km, Ferozepur Road, Lahore
Evaluation by PEC(VI): The firm has submitted report on assessment and confirmation of manufacturing
capacity for contract manufacturing dated 21-04-2020. The Registration Board allowed contract
manufacturing from Novamed Pharmaceuticals.
Decision: Approved.
Applicant Faislabad
Brand Name +Dosage Form + Strength DualCef 1gm IV/IM Injection
Cefoperazone…500mg
Sterile Powder of Sulbactam Sodium Eq. to
Sulbactum…500mg
Type of Form Form 5
Decision of 293rd :
control capacity of M/s Novamed Pharmaceuticals (Pvt.) Ltd. 28-km, Ferozepur Road, Lahore
capacity for contract manufacturing dated 21-04-2020. The registration board allowed contract
Decision: Approved.
Applicant Faislabad
Diary No. Date of R& I & fee Dy.No. 36785 dated 06-11-2018 Rs.50,000/-Dated 06-11-2018
Brand Name +Dosage Form + Strength DualCef 500mg IV/IM Injection
Combin
NeoSum
Cefoperazone…250mg
Sterile Powder of Sulbactum Sodium Eq. to
Sulbactum…250mg
Type of Form Form 5
Approval status of product in Reference PMDA Approved
Me-too status Ceflactam Injection 500mg M/s Barret Hodgson
Decision of 293rd :
control capacity of M/s Novamed Pharmaceuticals (Pvt.) Ltd. 28-km,Ferozepur Road, Lahore
capacity for contract manufacturing dated 21-04-2020. The registration board allowed contract
Decision: Approved.
84. Name and address of manufacturer / M/s Wilshire Laboratories Pvt ltd, 124/1 Industrial Estate, KOt
Applicant Lakhpat Lahore
Diary No. Date of R& I & fee Dy.No. 324 dated 6-07-2011 Rs.8,000/- Dated 6-07-2011, Rs.
12,000 dated 9-01-2015 (Duplicated fee Chalan)
Brand Name +Dosage Form + Strength Zimid 30mg Injection Vial
Composition Each vial contains:
Lansoprazole….30mg
Pharmacological Group PPI
Type of Form Form 5
Approval status of product in Reference USFDA “Prevacid 30mg lsterile lyophilized powder for injection
Me-too status Qipro 30mg injection Reg. 015133 by Bosch.
GMP status Wilshire: cGMP certificate is granted based on inspection dated
26-9-2017.
Remarks of the Evaluator.
Decision of 295th :
Deferred for the confirmation of manufacturing facility of the applied product.
Evaluation by PEC(VI): The firm has submitted that they will procure lyophilized powder from
manufacturers which it then fills in the vial. We have dry powder injection (General) section.
Decision: Deferred for confirmation whether manufactured via lyophilisation or dry powder filling.
85. Name and address of manufacturer / M/s Wilshire Laboratories Pvt ltd, 124/1 Industrial Estate, KOt
Applicant Lakhpat Lahore
Diary No. Date of R& I & fee 0987, 6-06-2011, 8,000/- 6-6-2011, Rs. 12,000, 14-1-2015
(Duplicate Dossier)
Brand Name +Dosage Form + Strength Agitanil 10mg Injection
Olanzapine…..10mg
Pharmacological Group Atypical Antipsychotic
Type of Form Form 5
Pack size & Demanded Price A per SRO
GMP status cGMP certificate is granted based on inspection dated
26-9-2017.
Remarks of the Evaluator. Fee challan photocopy attached.
Decision of 295th :
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
Evaluation by PEC(VI): The firm has submitted Zyprexa 10mg Injection USFDA Approved and me too as
Zanzia 10mg Injection Reg No 077089 by English Pharma
Decision: Deferred for confirmation whether product will be manufactured by way of lyophilisation
or dry powder filling along with scientific details
86. Name and address of manufacturer / "M/s Maxitech Pharma Pvt Ltd.Plot No. E-178, S.I.T.E. Super
Applicant Highway, Phase II, Karachi"
Brand Name+Dosage Form+ Strength Maxzid 4mg Tablet
Composition "Each film coated tablet contains:
Tizanidine HCl eq to Tizanidine…4mg"
Pharmacological Group Muscle Relaxants, Centrally Acting Agents
M03BX02
Type of Form Form 5
Pack size & Demanded Price As per PRC.
Approval status of product in Reference Zanaflex®
Regulatory Authorities. USFDA Approved.
Me-too status 080865; "Zinzan 4mg Tablet
"Wellborne Pharmachem and Biologicals, Hattar."
GMP status 21-02-2019 Conclusion:
Based on above observations and keeping in view the attitude of
the management of the firm towards constant improvement their
current GMP compliance level is rated as Good.
Remarks of the Evaluator.  Evidence of approval of applied formulation as film coated
tablet in reference regulatory authorities/ agencies which were
declared/approved by the Registration Board in its 275th
meeting.
Decisionof 292nd : Deferred for evidence of approval of applied formulation as film coated tablet in reference
regulatory authorities/agencies which were declared/approved by the Registration Board in its 275th meeting
or revision of formulation from film coated tablet to uncoated tablet with submission of requisite fee.
Evaluation by PEC(VI): The firm has revised the formulation from film coated to uncoated tablet with the
submission of Rs.5,000 (Duplicate/copy) Deposit No1936832.
Decision: Approved
87. Name and address of manufacturer / "M/s Maxitech Pharma Pvt Ltd.Plot No. E-178, S.I.T.E. Super
Applicant Highway, Phase II, Karachi"
Brand Name+Dosage Form+ Strength Maxzid 2mg Tablet
Composition "Each film coated tablet contains:
Tizanidine HCl eq to Tizanidine…2mg"
Pharmacological Group Muscle Relaxants, Centrally Acting Agents (M03BX02)
Type of Form Form 5

Pack size & Demanded Price As per PRC.
Approval status of product in Reference Zanaflex®
Me-too status 078514 ; Xinasia Tablets
Med Asia Pharmaceuticals (Pvt) Ltd., Risalpur
GMP status 21-02-2019 Conclusion:
Based on above observations and keeping in view the attitude of
the management of the firm towards constant improvement their
current GMP compliance level is rated as Good.
Remarks of the Evaluator. Evidence of approval of applied formulation as film coated tablet
in reference regulatory authorities/ agencies which were declared/
approved by the Registration Board in 275th meeting.
nd
Decision of 292 : Deferred for evidence of approval of applied formulation as film coated tablet in reference
regulatory authorities/agencies which were declared/approved by the Registration Board in its 275th meeting
or revision of formulation from film coated tablet to uncoated tablet with submission of requisite fee.
Evaluation by PEC(VI): The firm has revised the formulation from film coated to uncoated tablet with the
submission of Rs.5,000 (Duplicate/copy) Deposit No193681.
Decision: Approved.
88. Name and address of manufacturer / M/s Biogen Pharma. 8-Km, Chakbeli Road, Rawat, Rawalpindi,
Applicant Pakistan
Diary No. Date of R& I & fee Form-5 Dy.No 32456 dated 28-09-2018 Rs.20,000/-28-09-2018
Brand Name +Dosage Form + Strength Hi-Doxy-50 Oral Powder
Composition Each 100 gm Contains:
Doxycycline Hyclate…50gm
Pharmacological Group Tetracycline
Type of Form Form-5
Finished product Specification Innovators
Pack size & Demanded Price 100gm,500gm, 1000gm
Me-too status 049736 DOXYCYCLIN 500 WATER SOLUBLE POWDER.
GMP status 26-10-2018. The firm is not found working as required under the
law/rule.
Decision of 293rd : Deferred for updated GMP status of the firm from QA&LT Division.
Evaluation by PEC(VI):The firm has submitted panel inspection report dated 25-11-2019, the panel
recommended renewal of DML.
Decision: Approved with innovator’s specification.
89. Name and address of manufacturer / M/s Biogen Pharma. 8-Km, Chakbeli Road, Rawat, Rawalpindi,
Applicant Pakistan
Diary No. Date of R& I & fee Form-5 Dy.No 32457 dated 28-09-2018 Rs.20,000/- 28-09-2018
Brand Name +Dosage Form + Strength Biotak Oral Paste
Composition Each ml of Paste Contains:
Abamectin…4mg
Praziquantel…50mg
Type of Form Form-5
Pack size & Demanded Price 5ml, 10ml, 20ml, 30ml, 50ml, 100ml
Me-too status 034518 EQUITAK ORAL PASTE.
GMP status 26-10-2018. The firm is not found working as required under the
law/rule
Decision: Deferred for updated GMP status of the firm from QA&LT Division.
Evaluation by PEC(VI):The firm has submitted panel inspection report dated 25-11-2019, the panel

Decision: Deferred for confirmation of required manufacturing facility for applied dosage form.
90. Name and address of manufacturer / "M/s Wnsfeild Pharmaceuticals. Plot # 122, Block A, Phase V,
Applicant Hattar Industrial Estate, Hattar"
Brand Name +Dosage Form + Strength Artidoxin 100/25/500 mg Tablet
Composition "Each Combokit Contains:
Sulfadoxine+Pyremethamine Tablets:
Each Uncoated Tablet Contains:
Sulfadoxine…500mg
Pyremethamine…25mg
Artesunate Tablets
Each Uncoated Tablet Contains:
Artesunate…100mg"
Pharmacological Group Antimalarial.
Type of Form Form 5
Finished product Specification Sulfadoxine+Pyremethamine (USP), Artesunate (IP)
Pack size & Demanded Price 1x9’s, (3+6). As per SRO.
Approval status of product in Reference WHO prequalified Drug.
Regulatory Authorities. Manufacturer of Prequalified Product: Guilin Pharmaceutical Co.
Ltd.Oral Solid Dosage workshop (OSD-1),No. 43 Qilidian Road,
Guilin, Guangxi, China, 541004
Me-too status 045098 Artesul Tablets for Adults
M/s Zafa Pharmaceutical, Karachi
GMP status 18-01-2018. Conclusion:
“As per observations made, facilities of production and quality
control inspected, technical staff employed and keeping in view
the overall CGMP compliance status of the firm, the panel
unanimously recommend the renewal of DML no. 000610 by way
of formulation granted to M/s Wnsfield Pharma Hattar.”

Decision of 291st : The Registration Board deferred for submission of evidence of availability of co-blister
machine.
Evaluation by PEC(VI): The firm has submitted a letter written by FID Peshawar to DDG Peshawar dated
3-4-2015 confirming the co-blister machine.
Decision: Deferred for confirmation of co-blister machine from inspection report.
91. Name and address of manufacturer / M/s Novartana Pharmaceuticals Pvt Ltd.
Applicant Plot No. 87-B, Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Novofen Suspension 100mg/5ml
Ibuprofen………100mg"
Pharmacological Group NSAID
Type of Form Form 5
Pack size & Demanded Price Rs 30.00/pack of 60ml, Rs 55.00/pack of 120ml,
Approval status of product in Reference MHRA Approved.
Me-too status 062324
"Pironec Suspension
"Atlantic Pharmaceutical (Pvt) Ltd,89-D, Industrial Eastate,
Hayatabad,Peshawar.(contract manufacturing from M/s Polyfine
Chempharma, Peshawar)"
GMP status CLB in its 267th meeting held on 31st December 2018.Has
considered and approved the renewal of DML.
Remarks of the Evaluator. The manufacturing outline of applied formulation has not been
provided. Firm has liquid syrup, Capsule and Tablet section.
Decision of 295th : Deferred for submission of manufacturing outline for applied formulation.
Evaluation by PEC(VI): The firm has submitted the manufacturing outline.
Decision: Approved
92. Deleted due to duplication with Sr no 91.
93. Name and address of manufacturer / M/s Novartana Pharmaceuticals Pvt Ltd.
Applicant Plot No. 87-B, Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Thiosid Capsules 8mg
Composition Each Capsule Contains:
Thiocolchicoside…8mg"
Type of Form Form 5
Pack size & Demanded Price Rs. 525/pack 2x10‟s Capsule.
Approval status of product in Reference MuscoRil 4 mg capsule rigide
Regulatory Authorities. MuscoRil 8 mg capsule rigide
AIFA Approved
Me-too status 069906 "Caelyx Capsules
M/s Rotex Medica Pakistan (Pvt) Ltd., P.No. 206-207, Industrial
Triangle, Kahuta Road, Islamabad
GMP status CLB in its 267th meeting held on 31st December 2018.Has
considered and approved the renewal of DML.
Remarks of the Evaluator. The manufacturing outline of applied formulation has not been
provided.
European Medicines Agency recommends restricting use of
thiocolchicoside by mouth or injection.
Medicine only to be used at low doses for additional short-term
relief of painful muscle contractures
Decision of 295th :
Deferred for submission of manufacturing outline for applied formulation.
Evaluation by PEC(VI): The firm has submitted the manufacturing outline.
94. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial Estate,
Applicant Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Depin Tablet 12.5mg
Composition Each enteric film coated controlled release tablet contains:
Paroxetine as HCl…12.5mg"
Pharmacological Group Anti-depressant, SSRI
Type of Form Form-5
Finished product Specification USP extended release monograph.
Pack size & Demanded Price 10‟s,14‟s,30‟s, As per SRO.
Approval status of product in Reference PAXIL CR (paroxetine) extended-release tablets
Me-too status Panox CR Tablet 12.5 mg Reg. No. 081953 of M/s Regal
Pharmaceuticals,Islamabad
GMP status Last inspection dated 08-07-2019 & 25-07-2019 concluded that
M/s Pharmasol, Lahore was operating at satisfactory level of GMP
compliance.
Previous decision Deferred in 295th meeting for revision of formulation as per
innovator / reference product along with submission of requisite
fee.
Evaluation by PEC(VI) The firm has initially applied for “each enteric coated tablet
contains: Paroxetine as HCl 12.5mg, later the firm has revised its
formulation as per the reference product and submitted PKR
5,000/- fee. Dated 31-8-2020 Deposit Slip No0814923
Decision: Deferred for submission of differential fee of Rs. 15000/-.
95. Name
2 and address of manufacturer / M/s Pharmasol (Pvt) Ltd.Plot No. 549, Sundar Industrial Estate,
Brand Name +Dosage Form + Strength Depin Tablet 25mg
Paroxetine as HCl…25mg
Type of Form Form-5
Me-too status Panox CR Tablet 25 mg Reg. No. 081954 of M/s Regal
Pharmaceuticals, Islamabad
compliance.
Previous decision Deferred in 295th meeting for revision of formulation as per the
innovator / reference product along with submission of requisite
fee.
contains: Paroxetine as HCl 25mg, later the firm has revised its
96. Name
3 and address of manufacturer / M/s Pharmasol (Pvt) Ltd.Plot No. 549, Sundar Industrial Estate,
Brand Name +Dosage Form + Strength Depin Tablet 37.5mg
Paroxetine as HCl…37.5mg
Type of Form Form-5
Me-too status Deroxat CR 37.5mg Tablet Reg. No. 069948 of M/s Global
Pharmaceuticals, Islamabad
compliance.
Previous decision Deferred in 295th meeting for revision of formulation as per
innovator/reference product alongwith submission of requisite fee.
contains: Paroxetine as HCl 37.5mg, later the firm has revised its
97. Name
4 and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial Estate,
Brand Name +Dosage Form + Strength Dopicard Injection 200mg/5ml
Dopamine HCl…200mg
Pharmacological Group Monoamine oxidase B inhibitors
Type of Form Form-5
Pack size & Demanded Price 1‟s,10‟s,50‟s,100‟s, 5ml glass ampoules
Approval status of product in Reference Dopamine Hydrochloride 40mg/ml Concentrate for Solution for
Regulatory Authorities. Infusion by M/s Mercury Pharma International Ltd (MHRA)
Approved
Me-too status Dopamine 200mg Injection Reg. No. 005935 of M/s LC & PW
compliance.
Previous decision Deferred in 295th meeting for
Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/approved by
the Registration Board in its 275th meeting.
Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration number,
brand name and name of firm.
Evaluation by PEC(VI) The firm has initially applied for “each 5ml ampoule contains:
Dopamine HCl…40mg, later the firm has submitted revised Form-
5 as per the reference product i.e each 5ml ampoule contains:
Dopamine HCl…200mg and submitted PKR 20,000/- fee. Dated
31-8-2020 Deposit Slip No0814925
Decision: Approved
98. Name and address of manufacturer / "M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Applicant Estate,Lahore"
Brand Name +Dosage Form + Strength AVN-Plus 10/10mg Tablet
Composition "Each delayed release film coated tablet contains:
Doxylamine Succinate…10mg
Pyridoxine HCL…10mg"
Pharmacological Group Antihistamines for Systemic Use,
Vitamin
Type of Form Form 5
Finished product Specification Inhouse
Pack size & Demanded Price 1x30, As per SRO,10% less then brand leader.
Approval status of product in Reference Xonvea 10 mg/10 mg gastro-resistant (film coated)
Regulatory Authorities. MHRA Approved.
Me-too status 75838 Brand Name: Vomipreg Tablet
Manufacturer Name : Nexus Pharma,
GMP status 13-02-2020 Firm was GMP Compliant on the day of inspection.
Previous Remarks of the Evaluator (V)  Evidence of applied formulation as film coated tablets in
reference regulatory authorities/agencies which were
declared/approved by Registration Board in 275th meeting.
Firms Response
Firm has revised their formulation from immediate release to
delayed release tablet with submission of Rs, 5000/-.
Shortcoming
 The form 5 refers to Annexure A to D but the relevant
data has not been submitted.
Firms Response
Annexure A to D has not been provided by the firm.
Previous decision (M-295) Deferred for submission of application with all its annexure.
Firm’s response(VI) Firm has submitted relevant data for the annexures of Form 5
including master formulation and manufacturing method.

Brand Name +Dosage Form + Strength Ketero 10mg Tablet
Composition "Each Film Coated Tablet Contains:
Ketorolac Tromethamine…10mg"
Pharmacological Group Acetic acid derivatives and related substances,NSAID
M01AB15
Type of Form Form-5
Pack size & Demanded Price 14’s, As per SRO,10% less then brand leader.
Approval status of product in Reference Toradol oral tablets
Regulatory Authorities. (ketorolac tromethamine tablets) USFDA Approved.
Me-too status 060804 Brand Name: Kelac
Manufacturer Name: Rotex Pharma (Pvt.) Ltd. (Formerly Rotex
Medica)
GMP status 13-02-2020
Firm was GMP Compliant on the day of inspection.
Previous Remarks of the Evaluator (V)  The signature of applicant is missing on Form 5.
Previous decision (M-295) Deferred for submission of signed application on Form 5.
Firm’s response(VI) Firm has submitted signed copy of Form 5.
Decision: Approved.
Brand Name +Dosage Form + Strength Coblmn 500mcg Tablet
Composition "Each sugar coated tablet contains:
Mecobalamin…500mcg"
Pharmacological Group Vitamin B12.
Type of Form Form 5
Approval status of product in Reference
PMDA Approved sugar coated
Me-too status 081876; Brand Name: Heam 500 mcg Tablet
Manufacturer Name: Linear Parma,
 The applied formulation is sugar coated tablet whereas,
master formulation and manufacturing method is of film
coated tablet.
Previous decision (M-295) Deferred for the following:
•Submit master formulation & manufacturing method of relevant
formulation which is mecobalamin 500mcg sugar coated tablet.
•Submit signed application on Form 5.
Firm’s response(VI) Firm has submitted signed copy of Form 5 along with master
formulation and manufacturing method for sugar coated tablets.
Decision: Approved
Brand Name +Dosage Form + Strength Enox Tablet 400mcg
Enoxacin Sesquihydrate…400mg"
Pharmacological Group Fluoroquinolones
J01MA04
Type of Form Form 5
Finished product Specification Manufacturer’s Specifications
Approval status of product in Reference Discontinued in USFDA.
Me-too status 010174; Enoxabid 400mg Tab M/s Abbott
Previous decision (M-295) Deferred for the following submission of signed application of
applied formulation on Form 5.
Firm’s response(VI) Firm has submitted signed copy of Form 5.
Decision: Deferred for the confirmation of product discontinuation reasons in USFDA.
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New DML
Extension in implementation timelines of SRO 713(I)/2018
The Authority in its 72nd meeting discussed regarding the “Extension in implementation timelines of SRO
713(I)/2018 and decided as follows:-
1. Allowed those companies, for which panel for inspection has been constituted before 07-03-2019, to
submit registration applications on Form 5 instead of Form 5F for initial 10 molecules per section only.
2. The exemption will remain valid till 31-12-2019.
3. No further exemption will be granted in any case.
4. Inspectors / panel members are advised to formally report every visit. Concerned
Division were advised to specify a timelines for conducting/ concluding panel inspection.
Name of Firm Date of issuance Date of Date of Consideration of
of panel issuance of Submission of application in
inspection letter DML applications Registration Board
M/s KBR 8th March 2018 28th June 2019 November 2019
Pharmaceuticals, Hattar
The submission of following applications on foirm-5 are in line with the decision of Authority
M/s. KBR Pharmaceuticals, Plot # 123 - B, Phase V, Industrial Estate, Hattar.
Cream & Ointment Section (General) 16 products/ 7 molecules
102. Name and address of manufacturer / M/s KBR Pharmaceuticals, 123 - B, Phase V, Industrial Estate,
Applicant Hattar
Brand Name +Dosage Form + Strength Rizonal Lotion 2 % w/w
Diary No. Date of R& I & fee Diary No: 23226 , 08-11-2019 , Rs: 20,000/- , 06-11-2019
Composition Each gm Contains:
Ketoconazole…20mg (2% w/w)
Pharmacological Group Antifungals for topical use
Type of Form Form-5
Finished Product Specification BP Specs
Pack size & Demanded Price 60 mL & 100 mL / As per SRO
Approval status of product in Dandrazol 2 % W/W Topical Solution
Reference Regulatory Authorities. Transdermal Limited, Merlin House, Brunel Road, Theale,
Reading,RG 7 4 AB (MHRA)
Me-too status Ketocal Lotion by M/s Caliph Pharma
GMP status New License ( DML # 000906 Dated 28-06-2019)
Decision: Deferred for the confirmation of manufacturing facility i.e. Lotion section
Applicant Hattar
Brand Name +Dosage Form + Strength Rizonal Cream 2 % w/w
Composition Each Gram Contains:
Ketoconazole…20mg (2% w/w)
Pharmacological Group Antifungals for topical use
Type of Form Form-5
Finished Product Specification BP Specs
Pack size & Demanded Price 5 g , 10 g& 15 g / As per SRO
Approval status of product in Ketoconazole Cream 2% by Taro Pharmaceuticals Inc.,
Reference Regulatory Authorities. Brampton, Ontario, Canada L6T 1C1
Me-too status Ketocon Cream by M/s Valour Pharma
Decision: Approved
Applicant Hattar
Brand Name +Dosage Form + Strength Rezemus Ointment 0.1 % w/w
Tacrolimus (as monohydrate)………… 1 mg (0.1 %w/w)
Pharmacological Group Macrolide Calcineurin Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10 g& 30 g / As per SRO
Approval status of product in PROTOPIC (tacrolimus) Ointment 0.1%w/w
Reference Regulatory Authorities. M/s LEO PHARMA AS (USFDA Approved)
Me-too status Crolimus Cream by M/s Valor Pharma
Applicant Hattar
Brand Name +Dosage Form + Strength Rezemus Ointment 0.03 % w/w
Composition Each Gram of Ointment Contains:
Tacrolimus (as monohydrate)………… 0.3 mg (0.03 %w/w)
Pharmacological Group Macrolide Calcineurin Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10 g& 30 g / As per SRO
Approval status of product in PROTOPIC (tacrolimus) Ointment 0.03%w/w
Reference Regulatory Authorities. M/s LEO PHARMA AS (USFDA Approved)
Me-too status Crolimus Cream by M/s Valor Pharma

Applicant Hattar
Brand Name +Dosage Form + Strength Rinoxin Lotion 2 % w/v
Composition Each mL Contains:
Minoxidil……………..20 mg (2%w/v)
Pharmacological Group Other dermatologicals
Type of Form Form-5
Finished Product Specification USP Specs
Approval status of product in Regaine for men extra strength topical solution by
Reference Regulatory Authorities. McNeil (MHRA Approved)
Me-too status Minoxical Lotion by M/s Caliph Pharma
Applicant Hattar
Brand Name +Dosage Form + Strength Rinoxin Lotion 5 % w/v
Composition Each mL of Lotion Contains:
Minoxidil……………..50 mg (5%w/v)
Type of Form Form-5
Approval status of product in Regaine for men extra strength topical solution by
Reference Regulatory Authorities. McNeil (MHRA Approved)
Me-too status Minoxical Lotion by M/s Caliph Pharma
Applicant Hattar
Brand Name +Dosage Form + Strength Removate Ointment 0.05 % w/w
Clobetasol Propionate…………0.5mg (0.0.5%w/w)
Pharmacological Group Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 5 g, 10 g, 15 g & 25 g / As per SRO
Approval status of product in Impoyz 0.05%w/w OINTMENT
Reference Regulatory Authorities. Manufactured for Promius Pharma LLC., by DPT
Laboratories Inc., San Antonio, TX 7821
Me-too status Clobetacal by M/s Caliph Pharma
Decision: Approved
Applicant Hattar
Brand Name +Dosage Form + Strength Removate Cream 0.05 % w/w
Clobetasol Propionate…………0.5mg (0.0.5%w/w)
Type of Form Form-5
Approval status of product in MHRA Approved
Reference Regulatory Authorities.
Decision: Approved
Applicant Hattar
Brand Name +Dosage Form + Strength Removate Lotion 0.05 % w/v

Clobetasol Propionate…………0.5mg (0.05%w/v)
Type of Form Form-5
Approval status of product in Impoyz 0.05%w/v Manufactured for Promius Pharma LLC., by
Reference Regulatory Authorities. DPT Laboratories Inc., San Antonio, TX 7821
Applicant Hattar
Brand Name +Dosage Form + Strength Ransomet Cream 0.1 % w/w
Mometasone Furoate……………..1mg (0.1%w/w)
Pharmacological Group Corticosteroid, potent group III
Type of Form Form-5
Me-too status Mometacal by M/s Caliph Pharma
Remarks of the Evaluator. (VI) Segregated dispensing booth for steroid products are not confirmed
Decision: Deferred for the confirmation of segregated booth for steroid products as per
decision of CLB.
Applicant Hattar
Brand Name +Dosage Form + Strength Ransomet Ointment 0.1 % w/w
Mometasone Furoate……………..1mg (0.1%w/w)
Type of Form Form-5
Approval status of product in USFDA Approved
Me-too status Momate by M/s Maxitech Pharma
Decision: Deferred for the confirmation of segregated booth for steroid products as per
decision of CLB.
Applicant Hattar
Brand Name +Dosage Form + Strength Ransomet Lotion 0.1 % w/v
Diary No. Date of R& I & fee Diary No: 23236, 08-11-2019 , Rs: 20,000/- , 06-11-2019
Mometasone Furoate……………..1mg (0.1%w/v)
Type of Form Form-5
Approval status of product in Elocon 0.1% w/w scalp lotion by Merck
Reference Regulatory Authorities. (MHRA Approved)
Me-too status Mometacal by M/s Caliph Pharma
Decision: Deferred for the confirmation of segregated booth for steroidal products as per
decision of CLB and manufacturing facility i.e. Lotion section
Applicant Hattar
Brand Name +Dosage Form + Strength Rotrin Lotion 5 % w/v
Permethrin……………..50 mg (5%w/v)
Pharmacological Group Anti infective
Type of Form Form-5
Approval status of product in Permethrin 5 % w/v Lotion M/s GSK
Me-too status Pestlin by M/s Atco Pharma
Applicant Hattar
Brand Name +Dosage Form + Strength Rotrin Cream 5 % w/v
Composition Each gram contains:
Permethrin……………..50 mg (5%w/w)
Type of Form Form-5
Pack size & Demanded Price 10 g & 30 g / As per SRO
Approval status of product in LYCLEAR Dermal Cream 5 % w/w Omega Pharma ,UK
Me-too status Nixcal by M/s Caliph Pharma
Applicant Hattar
Brand Name +Dosage Form + Strength Ralagin V Lotion 1 % w/v
Clindamycin (as Phosphate)……………..10 mg (1% w/v)
Pharmacological Group Lincomycin Antibiotics
Type of Form Form-5
Approval status of product in Cleocin T 1% Lotion by M/s Pfizer MHRA Approved
Me-too status Acsolve Lotion by M/s Atco Pharma

Applicant Hattar
Brand Name +Dosage Form + Strength Ralagin V Cream 2 % w/w
Composition Each gram Contains:
Clindamycin (as Phosphate)……………..20 mg (2% w/w)
Pharmacological Group Lincomycin Antibiotics
Type of Form Form-5
Pack size & Demanded Price 10 g, 20 g & 40 g / As per SRO
Approval status of product in Dalacin 2% Cream (MHRA Approved)
Me-too status Clindacal by M/s Caliph Pharma
Decision: Approved.
a. Deferred cases of New/Additional section(s)

118. Name and address of manufacturer / M/s Jinnah Pharmaceuticals Pvt Ltd.
Applicant 13 km, Lahore Road, Multan
Brand Name +Dosage Form + Strength Jolip 10mg Tablet
Composition Each film coated Tablet Contains:
Zolpidem as tartrate…10mg
Diary No. Date of R& I & fee Dy.No 16246 dated 06-03-2019 Rs. 20,000/- 07-03-2019
Pharmacological Group Sedative agents
Type of Form Form 5
Pack size & Demanded Price 1 x 14'S /As per SRO
Me-too status Olida 10mg Tablets of M/s Glitz Pharmaceuticals (Reg.# 081418)
GMP status New Section
Remarks of the Evaluator. (VI) The firm has initially applied the product as uncoated tablet , now
they revised it in film coated as per reference product along with
the submission of fee Rs. 5,000 dated 2-9-2020 Deposit Slip No.
2049329
Central Licensing Board in its 270th meeting held on 23rd MAY,
2019 has considered and approved the
following 2 additional section of firm M/s Jinnah Pharmaceuticals
Pvt Ltd.
13 km, Lahore Road, Multan as under:-
Sr. No Section
01 Tablet Section (Psychotropic/Narcotic)
02 Oral Liquid/Suspension General Section
Previous Decision Decision of 291st :
Deferred for consideration on its turn with respect to the queue.
Evaluation by PEC: (VI)
The firm has submitted that the above product is psychotropic. The same has been confirmed from green
list of INCB and also from controlled division.
Decision: Approved.

Case no. 06 Registration applications of import cases
a. New Cases (Human)
b. New Cases (Veterinary)
c. Deferred cases
i. Human
119. Name and address of Applicant M/s OBS Pakistan (Pvt.) Limited , C-14, Manghopir Road,
S.I.T.E Karachi
Detail of Drug Sale License Address: C-14, Manghopir Road, S.I.T.E Karachi
Validity: 23 May 2018
Status: Drug License by Way of Retail sale
Name and address of manufacturer M/s Santen Pharmaceutical Co. Ltd Shiga Plant
348-3, Aza-suwa, Oaza- shide, Taga-cho, Inukami-gun, Shiga, Japan
M/s Santen Pharmaceutical Co. Ltd Shiga Plant will be responsible for
• Preparation of drug solution process.
• Filtration for sterilization and filling process.
• Release testing of product.
and M/s Santen Pharmaceutical Co. Ltd Noto Plant 2-14,
Sikinami will be responsible for
• Packaging and labeling process.
• Release testing of product
• Batch release.
Name and address of marketing M/s Santen Pharmaceutical Co. Ltd Shiga Plant
authorization holder 348-3, Aza-suwa, Oaza- shide, Taga-cho, Inukami-gun, Shiga, Japan
Name of exporting country Japan
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No.3466 Dated 26-01-2018
Fee including differential fee Rs. 100,000/- Dated 26-01-2018
Brand Name +Dosage Form + Taflotan Opthalmic Solution 0.0015%w/v
Strength
Composition Each ml contains:
Tafluprost….15ug
Finished Product Specification Inhouse
Pharmacological Group Glaucoma and Ocular Hypertension
Shelf life 3 years
Demanded Price MRP as per Originator pack
Pack size 1’s 2.5ml polypropylene bottle with polypropylene dropper
International availability Approved in USFDA Zioptan By Merck Sharp, USA
Me-too status N/A
Detail of certificates attached Original legalized CoPP
Certificate No: 5141
Certifying Authority: Ministry of Health, Labour and Welfare,
Government of Japan
Free Sale: Confirms the free sale of the product in exporting country.
GMP: The facilities and operations conform to WHO-GMP. Issue
Date: 6-02-2017
GMP certificate
Certifying Authority: Ministry of Health, Labour and Welfare Issue
date: 27-01-2017
Free sale Certificate
Certifying Authority: Ministry of Health, Labour and Welfare Issue
Date:22-11-2017
Letter of Authorization
Date of Agreement:05-10-2017
Validity :3 Years

Remarks of the Evaluator. Firm provided the stability data at following conditions;
● Long term test: 25C/40%RH & 30/75%RH (36 months)
● Accelerated Test: 40C/NMT 25%RH
The submitted stability data for accelerated condition is not as per Zone
IV A requirement.
Firm submitted the following reply;
The stability testing was conducted in compliance with Stability testing
of New Drug Substances and Products.
The accelerated test conditions has been performed under low humidity
conditions 40C/25%RH instead of climate zone IVA high humidity
condition which is not recommended and preferred for semi permeable
container as stated in ICH.
A Significant change has been observed in assay value of Tafluprost for

all the three batches MTD1332, MTD1333 and MTD1334 at long term
stability condition. Clarify.
Upto 36 months storage at 30C/75% the decrease of tafluprost content is
observed (6.5%-6.7%).
The increase of the related substances as degradation product of
tafluprost are observed (1.6%-1.8%), but it is no problem for safety.
According to the above result , the amount of total degradation products
is less then the decrease of tafluprost content, it is considered that the
reason for the decrease of tafluprost are not only degradation but also
adsorption to container.
The results of the other tests items are within the specifications, and there
are no significant changes.
The stability is affected by temperature but it is stable for 36 months after
distribution under light protected and below 30C.
Previous Decision(M-282):
Deferred for the following reasons:
● Submission of long term stability data according to Zone IVA condition. Submitted data for long
term stability is at 25C/40%RH which is not according to Zone IVA for semi-permeable containers.
● Submission of test for determination of potential water loss in case of semipermeable membrane.
Evaluation by PEC: Firm submitted the following reply:
● Submission of long term stability data according to Zone IVA condition. Submitted data for long
term stability is at 25°C/40%RH which is not according to Zone IVA for semi- permeable containers.
Please note that the stability conducted on 25°C±2/40%±5 complies the criteria of WHO guidelines which
clearly states the condition in which whether the long term studies are performed at on 25°C±2/40%±5 or
30°C±2/35%±5 is determined by the climatic condition under which the FPP is intended to be marketed. .
Testing at 30 °C/35% RH can be an alternative to the storage condition at 25 °C/40% RH.
Also the region has claimed that incase of semi-permeable container, the low humidity condition
25°C±2/40%RH±5 is a more severe storage condition than high humidity condition 30 °C/35% RH.
Evaluation
However, the data is at 25 °C/40% RH and not at 30 °C/35% RH. Therefore, the stability is not as per
guideline.
Moreover, the low humidity condition is 30 °C/35% RH and not 25°C/40%RH.
The firm has performed stability testing according to ASEAN requirement i.e. at 30°C/75%RH but test for
water loss has not been conducted. Moreover, the stability data is of Shiga Plant whereas, M/s Santen
Pharmaceutical Co. Ltd Noto Plant 2-14, Sikinami will be responsible for
i. Packaging and labelling process.
ii. Release testing of product
iii. Batch release.
Decision of 288th : Deferred for the following reasons:
● Submission of long term stability data from M/s Santen Pharmaceutical Co. Ltd Noto Plant 2-14,
Sikinami according to Zone IVA condition. Submitted data for long term stability is at 25C/40%RH
which is not according to Zone IVA for semi-permeable containers.
● Submission of test for determination of potential water loss in case of semi-permeable membrane.

Evaluation by PEC(VI):
● The firm submitted the reply that they calculated stability data at 30 oC/35% RH and water loss
calculation for all the stability conditions in accordance with stability guidelines “Stability testing of
New Drug Substances and Products” ICH {ICH Q1A (R2). According to these guidelines an
alternative approach is recommended for studies at the low relative humidity that is to perform the
stability studies under higher relative humidity and deriving the water loss at the low relative
humidity through calculations.
● Firm proposed following solution for this:
The firm has proposed that the results derived from calculated data for 30oC and 35% RH has shown no
significant change in product specifications there was insignificant water loss to alter the product specifications
proven by results.
Decision: Deferred for further evaluation in accordance with the ICH stability studies guidelines
Case no. 07 Registration applications of drugs for which stability study data is submitted
a. New cases
b. Deferred cases
c. Verification of stability study data
d. Exemption from onsite verification of stability data
120. Name
1 and address of manufacturer/ M/s. Atco Laboratories Limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form+ Strength Ertugli 15mg tablets
Composition Each film coated tablets contains:
Ertugliflozin as L-Pyroglutamic acid……….15mg
Diary No. Date of R&I & fee 14th December, 2018, Rs. 50,000/-
Pharmacological Group Anti-diabetic
Type of Form Form-5D
Finished product Specifications Manufacturers Specification
Pack size & Demanded Price Pack Size: 7s, 10s, 14s, 20s, 28s & 30s
MRP: Rs. 4200/- per 7s, Rs. 6000/- per 10s, Rs. 8400/- per 14s, Rs.
12000/- per 20s, Rs. 16800/- per 28s, Rs. 18000/- per 30s.
Approval status of product in STEGLATRO TABLET 15mg
Reference
GMP statusRegulatory Authorities MERCK SHARP AND DOHMECORP USA.
Remarks of the Evaluator
STABILITY STUDY DATA
Drug Ertugli 15mg tablets
Name ofManufacturer M/s. Atco Laboratories (Pvt). Limited, B-18, S.I.T.E., Karachi.
ManufacturerofAPI Ertugliflozin as L-Pyroglutamic acid: Zhejiang Hongyuan Pharmaceutical Co,
Ltd.China
API Lot No. Ertugliflozin as L-Pyroglutamic acid: ET20180523
Description of Pack Alu-Alu blisters
(Container closure system) 1 x 10’s tablets
StabilityStorage Condition Accelerated: 40°C and 75% RH
Real Time: 30°C and 75% RH
Time Period Accelerated: 6months
Real Time: 12months
Frequency Accelerated: 0, 1, 3, 6 months
Real Time: 0, 3, 6,9,12 months
Batch No. 216 G 18 217 G 18 218 G 18
Batch Size 6000 Tablets 6000 Tablets 6000 Tablets

ManufacturingDate 01-08-2018 01-08-2018 01-08-2018
Date ofInitiation 25-08-2018 25-08-2018 25-08-2018
No. of Batches 03
Date of Submission 10-02-2020
DOCUMENTS IDATAPROVIDED BYTHEAPPLICANT
Sr. Documents ToBeProvided Status
No.
1. COA of API. Ertugliflozin as L-Pyroglutamic acid: Copy of COA
(Batch # ET20180523) from M/s Zhejiang Hongyuan
Pharmaceutical Co, Ltd. China is submitted.
2. Approval of API by regulatory authority of Ertugliflozin as L-Pyroglutamic acid: Copy of GMP
country of origin or GMP certificate of API certificate (certificate # ZJ20180032) issued by China
manufacturer issued by regulatory authority of Food and Drug administration is submitted. It is valid till
country of origin. 14-03-2023.
3. Protocols followed for conduction of stability
study and details of tests. Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc. Yes
5. Documents confirming import of API etc. Ertugliflozin as L-Pyroglutamic acid: The firm has
submitted copy of commercial invoice for the purchase of
Ertugliflozin as L-Pyroglutamic acid attested by DRAP,
Karachi dated 13-06-2018.
6. All provided documents will be attested (name,
sign and stamp) for ensuring authenticity of data Yes
/ documents.
7. Commitment to continuerealtime stability
studytillassigned shelflifeof the product. Yes
8. Commitment to follow DrugSpecification Yes
Rules,1978.
REMARKS OF EVALUATOR
REQUEST OFEXEMPTIONFROMONSITEINSPECTION
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided the
following documents in conjunction with the checklist approved by the Registration Board in its 278thMeeting:
AdministrativePortion
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product “Rofl
inspection for instant dosage form 500mcg tablet”, which was presented in 277th meeting of
conducted during last three years. Registration board. Registration Board decided to approve
registration of above stated drug product of M/s. Atco Laboratories
Limited, Karachi.
2. Documents for the procurement of API Ertugliflozin as L-Pyroglutamic acid: The firm has submitted copy
with approval from DRAP (in case of of commercial invoice for the purchase ofErtugliflozin as L-
import). Pyroglutamic acid attested by DRAP, Karachi dated13-06-2018.
3. Documents for the procurement The firm has submitted fffffcopy of COA of the following:
of reference standard and Ertugliflozin as L-Pyroglutamic acid Working Standard.
impuritystandards.

4. Approval of API/DML/GMP certificate Ertugliflozin as L-Pyroglutamic acid: Copy of GMP certificate
of API manufacturer issued by (certificate # ZJ20180032) issued by China Food and Drug
regulatory authority of country of administration is submitted. It is valid until 14-03-2023.
5. origin.
Mechanism for Vendor pre- The firm has submitted SOP for evaluation of vendors.
qualification
6. Certificate of analysis of Ertugliflozin as L-Pyroglutamic acid: Copy of COA
the API, reference standards and (Batch#ET20180402WS) from M/s. Zhejiang Hongyuan
impurity standards Pharmaceutical Co. Ltd, China is submitted.
7. Documents for the procurementof The firm has submitted photocopy of invoices/COAs of the excipient
excipients used in product used in the formulation of applied product.
development?
8. Listof qualified staff involved in The firm has submitted List of Qualified staff involved in product
product development with relevant development department.
experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of Protocols for the development
development & stability testing of trial of new product.
batches.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing Records
of three stability batches. of following 03 batches:
Batch No. Batch Size Mfg. Date
216G18 6000 Tablets 01-08-2018
217G18 6000 Tablets 01-08-2018
218G18 6000 Tablets 01-08-2018
11. Record of remaining quantities of Trial No. Total No. of Tablets used Remaining
stability batches. Tablets for for testing Quantities of
Stability Testing tablets
216G18 550 210 340

217G18 550 210 340
218G18 550 210 340
QA/QC DATA
=
12. Record of Digital data logger The Firm has submitted photocopies of data logger record for
for temperature and humidity chambers used in Real Time & Accelerated stability studies of
monitoring of stability chambers (real applied product from Aug-2018 to Aug-2019.
time and accelerated)
13. Method used for analysis of API The firm has submitted photocopy of Raw material
along with COA. specifications, raw material testing procedures along with COA
for Ertugliflozin L Pyroglutamic Acid.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product Testing
Complete record of testing of stability Procedure for “Ertugli 15mg Tablets” along with stability Study
batches (i.e. chromatograms, lab reports, reports.
raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted copy of accelerated, 06 Months (40°C ± 2°C
manufacturer. & 75±5%RH) & long term, 24Months (30°C ± 2°C & 65±5%RH)
stability study reports of 03 batches from M/s. Zhejiang Hongyuan
Pharmaceutical Co. Ltd, China according to zone IV A conditions.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports of excipients
used.
17. Drug-excipients compatibility studies. The firm has used the excipients of innovator.

18. Record of comparative dissolution data. Firm has provided justification that the formulation of our product
Ertugli Tablets Range is based on the formulation of Innovator
product. According to EMA Assessment Report
EMEA/H/C/004315/0000, the replacement of dissolution testing by
disintegration testing at release and stability is acceptable, as
Ertugliflozin is highly soluble and highly permeable and classified as
BCS class 1 molecule. Hence, on the basis of dissolution data, the
comparative studies may be waived and there is no need to calculate
similarity factor and product is stable and comparable.
19. Compliance Record of HPLC software The Firm has submitted audit trail reports for complete stability
21CFR & audit trail reports on product studies analysis of three batches at each time point.
testing.
Remarks of the Evaluator (VI):
The firm did not conduct dissolution studies. The firm submitted that our product is based on EMA assessment
report of innovator product which states that” The replacement of dissolution testing by disintegration testing at
release and stability is acceptable” So there is no need to perform dissolution test.
The firm has not performed content uniformity test during stability studies and submitted that as per WHO stability
testing Annex-10, Stability studies are performed on critical quality attributes and there is no need to perform content
uniformity test during stability studies.
Decision: Deferred for scientific justification for not perfoming dissolution studies since innovator has
performed dissolution test with limits of NLT Q in 15min.
121. Name
1 and address of manufacturer / M/s. Atco Laboratories Limited, B-18, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Ertugli 5mg tablets
Composition Each film coated tablets contains:
Ertugliflozin as L-Pyroglutamic acid……….5mg
Diary No. Date of R& I & fee Rs. 50,000/- R&I 14th December, 2018
Finished product Specifications Manufacturers Specification
Pack size & Demanded Price Pack Size: 7s, 10s, 14s, 20s, 28s & 30s
MRP: Rs. 1400/- per 7s, Rs. 2000/- per 10s, Rs. 2800/- per 14s, Rs.
4000/- per 20s, Rs. 5600/- per 28s, Rs. 6000/- per 30s
Approval status of product in STEGLATRO TABLET 5mg
Reference Regulator Authorities MERCK SHARP AND DOHMECORP, USA
GMP status
Drug Ertugli 5mg tablets
Name of Manufacturer M/s. Atco Laboratories (Pvt). Limited, B-18, S.I.T.E., Karachi.
Manufacturer of API Ertugliflozin as L-Pyroglutamic acid:
Zhejiang Hongyuan Pharmaceutical Co, Ltd.
API Lot No. Ertugliflozin as L-Pyroglutamic acid: ET20180523
Description of Pack Alu-Alu blisters
(Container closure system) 1 x 10’s tablets
Stability Storage Condition Accelerated: 40°C and 75% RH
Real Time: 30°C and 75% RH
Time Period Accelerated: 6months
Real Time: 12months

Frequency Accelerated: 0, 1, 3, 6 months
Real Time: 0, 3, 6,9,12 months
Batch No. 219 G 18 220 G 18 221 G 18
Manufacturing Date 01-08-2018 01-08-2018 01-08-2018
Date of Initiation 29-08-2018 29-08-2018 29-08-2018
No. of Batches 03

DOCUMENTS I DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
No.
1. COA of API. Ertugliflozin as L-Pyroglutamic acid: Copy of COA
(Batch # ET20180523) from M/s Zhejiang Hongyuan
Pharmaceutical Co, Ltd. China is submitted.
2. Approval of API by regulatory authority of Ertugliflozin as L-Pyroglutamic acid: Copy of GMP
country of origin or GMP certificate of API certificate (certificate # ZJ20180032) issued by China
manufacturer issued by regulatory authority of Food and Drug administration is submitted. It is valid till
country of origin. 14-03-2023.
study and details of tests. Yes
laboratory reports, data sheets etc. Yes
5. Documents confirming import of API etc. Ertugliflozin as L-Pyroglutamic acid: The firm has
submitted copy of commercial invoice for the purchase of
Ertugliflozin as L-Pyroglutamic acid attested by DRAP,
Karachi dated 13-06-2018.
6. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
authenticity of data I documents.
7. Commitment to continue real time stability
study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR(VI)
REQUEST OF EXEMPTION FROM ON SITE INSPECTION

following documents in conjunction with the checklist approved by the Registration Board in its 278th Meeting:
Administrative Portion
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product “Rofl
inspection for instant dosage form 500mcg tablet”, which was presented in 277th meeting of Registration
conducted during last two years. board. Registration Board decided to approve registration of above
stated drug product of M/s. Atco Laboratories Limited, Karachi.
2. Documents for the procurement of API Ertugliflozin as L-Pyroglutamic acid: The firm has submitted
with approval from DRAP (in case of copy of commercial invoice for the purchase of Ertugliflozin as L-
import). Pyroglutamic acid attested by DRAP, Karachi dated13-06-2018.

3. Documents for the procurement of The firm has submitted copy of COA of the following:
reference standard and impurity Ertugliflozin as L-Pyroglutamic acid Working Standard.
standards.
4. Approval of API/DML/GMP certificate Ertugliflozin as L-Pyroglutamic acid: Copy of GMP certificate
of API manufacturer issued by (certificate # ZJ20180032) issued by China Food and Drug
regulatory authority of country of origin. administration is submitted. It is valid until 14-03-2023.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for evaluation of vendors.
6. Certificate of analysis of the API, Ertugliflozin as L-Pyroglutamic acid: Copy of COA
reference standards and impurity (Batch#ET20180402WS) from M/s. Zhejiang Hongyuan
standards Pharmaceutical Co. Ltd, China is submitted.
7. Documents for the procurement of The firm has submitted photocopy of invoices/COAs of the excipient
excipients used in product development? used in the formulation of applied product.
8. List of qualified staff involved in product The firm has submitted List of Qualified staff involved in product
development with relevant experience. development department.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of Protocols for the development
development & stability testing of of new product.
trial batches.
10. Complete batch manufacturing record The firm has submitted photocopy of Batch Manufacturing Records
of three stability batches. of following 03 batches:
219G18 8000 Tablets 01-08-2018
220G18 8000 Tablets 01-08-2018
221G18 8000 Tablets 01-08-2018
11. Record of remaining quantities of Trial No. Total No. of Tablets used Remaining
stability batches. Tablets for for testing Quantities of
Stability Testing tablets
219G18 550 210 340

220G18 550 210 340
221G18 550 210 340
QA I QC DATA
=
12. Record of Digital data logger The Firm has submitted photocopies of data logger record for
for temperature and humidity chambers used in Real Time & Accelerated stability studies of
monitoring of stability chambers (real applied product from Aug-2018 to Aug-2019.
time and accelerated)
13. Method used for analysis of API along The firm has submitted photocopy of Raw material
with COA. specifications, raw material testing procedures along with COA
for Ertugliflozin L Pyroglutamic Acid.
14. Method used for analysis of FPP The firm has submitted photocopy of Finished Product Testing
& Complete record of testing of stability Procedure for “Ertugli 5mg Tablets” along with stability Study
batches (i.e. chromatograms, lab reports.
reports, raw data sheets etc.)
15. Reports of stability studies of API from The firm has submitted copy of accelerated, 06 Months (40°C ± 2°C
manufacturer. & 75±5%RH) & long term, 24Months (30°C ± 2°C & 65±5%RH)
stability study reports of 03 batches from M/s. Zhejiang Hongyuan
Pharmaceutical Co. Ltd, China according to zone IV A conditions.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical reports of excipients
used.
17. Drug-excipients compatibility studies. The firm has used the excipients of innovator.

18. Record of comparative dissolution data. Firm has provided justification that the formulation of our product
Ertugli Tablets Range is based on the formulation of Innovator
product. According to EMA Assessment Report
EMEA/H/C/004315/0000, the replacement of dissolution testing by
disintegration testing at release and stability is acceptable, as
Ertugliflozin is highly soluble and highly permeable and classified as
BCS class 1 molecule. Hence, on the basis of dissolution data, the
comparative studies may be waived and there is no need to calculate
similarity factor and product is stable and comparable.
19. Compliance Record of HPLC software The Firm has submitted audit trail reports for complete stability
21CFR & audit trail reports on product studies analysis of three batches at each time point
testing.
Remarks of the Evaluator (VI):

The firm did not conduct dissolution studies. The firm submitted that our product is based on EMA assessment
report of innovator product which states that” The replacement of dissolution testing by disintegration testing at
release and stability is acceptable” So there is no need to perform dissolution test.
The firm has not performed content uniformity test during stability studies and submitted that as per WHO stability
testing Annex-10, Stability studies are performed on critical quality attributes and there is no need to perform content
uniformity test during stability studies on the applied product.
Decision: Deferred for scientific justification for not perfoming dissolution studies since innovator has
performed dissolution test with limits of NLT Q in 15min.
Sr. Name and address Brand Name Type of Form, International Availability
No. of manufacturer / (Proprietary Name + Dosage Form Initial Diary & Date, / Local Availability
Applicant + Strength), Composition, Fee (including GMP Inspection Report
Pharmacological Group, differential fee), Date & Remarks
Finished Product Specification Demanded Price /
Pack size
122. M/s Getz Pharma GLARDIN-M Tablets 12.5mg + Form 5D SYNJARDY Tablets
Pvt. Ltd 850mg PKR 50,000/- 12.5mg + 850mg by
29-30, Sector 27, Each film coated tablet contains: 25-03-2016 Boehringer Ingelheim
Korangi Industrial Empagliflozin……………12.5mg 14’s : Rs. 4300/- Ltd, UK (MHRA
Area, Karachi Metformin HCl …….850mg Approved)
Anti-diabetic Last GMP Inspection
Manufacturer Specs. dated 16-12-2019
concluding acceptable
level of GMP
compliance status
Remarks of the Evaluator:
Drug GLARDIN-M Tablets 12.5mg + 850mg
M/s Getz Pharma Pvt. Ltd
Name of Manufacturer
29-30, Sector 27, Korangi Industrial Area, Karachi
Empagliflozin: M/s Jiangsu Yongan Pharmaceutical Co., Ltd. China
Manufacturer of API
Metformin HCl: M/s Wanbury Limited India
Empagliflozin: 20190322
API Lot No.
Metformin HCl: MT18751217
Description of Pack
(Container closure Alu-Alu blister packed in unit carton
system)
Stability Storage Real time : 30°C ± 2°C / 75% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Accelerated: 6 months
Frequency Real time: 0,3,6 (months)
Accelerated: 0,1,2,3,4,6 (months)
Batch No. 489DS01 489DS02 489DS03
Manufacturing Date 24.05.2019 20.06.2019 20.06.2019
No. of Batches 03
Date of Submission
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
# Documents To Be Provided Status
1. COA of API Yes
Approval of API by regulatory authority of Firm has submitted copy of GMP certificate of M/s Jiangsu
country of origin or GMP certificate of API Yongan Pharmaceutical Co., Ltd. China issued by Jiangsu
manufacturer issued by regulatory authority of Fooad and drug administration. (Certificate #
2. country of origin. JSHAHAQ2017005). The certificate is valid till 3-3-2021.
Firm has submitted copy of GMP certificate of M/s Wanbury
Limited India (Certificate # 3083/Stores/2019). The certificate
is valid till 06-02-2022.
Protocols followed for conduction of stability
3. Yes
study and details of tests.
Data of 03 batches will be supported by
attested respective documents like
4. Yes
chromatograms, laboratory reports, data
sheets etc.
Firm has submitted ADC attested invoice confirming import of
10 Kg Empagliflozin dated 05-04-2019 for Batch No.
20190322.
5. Documents confirming import of API etc.
1000 Kg Metformin HCl from M/s Wanbury Limited India
dated 16-01-2018 for Batch No. MT18751217.
All provided documents will be attested
6. (name, sign and stamp) for ensuring Yes
authenticity of data / documents.
Commitment to continue real time stability
7. Yes
study till assigned shelf life of the product.
Commitment to follow Drug Specification
8. Yes
Rules, 1978.
DATA FOR EXEMPTION FROM ONSITE INVESTIGATION OF SUBMITTED STABILITY DATA
Firm has referred to onsite inspection report of their product for
Arcox (Etoricoxib) Tablets 90mg & 120mg on 17th September,
2018 and was presented in 286th Drug Registration Board meeting
held on 14th – 16th November, 2018. The case was approved and
the inspection report confirms following points:
Reference of last onsite panel inspection  The HPLC software is 21CFR Compliant as per record
1 for instant dosage form conducted available with the firm.
during last two years  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.

Firm has submitted ADC attested invoice confirming import of 10
Kg Empagliflozin dated 05-04-2019 for Batch No. 20190322.
Documents for the procurement of API
2 with approval from DRAP (in case of
import)
1000 Kg Metformin HCl from M/s Wanbury Limited India dated
16-01-2018 for Batch No. MT18751217.
Documents for the procurement of
Firm has submitted COA and invoice of reference standard and
3 reference standard and impurity
impurity standards.
standards
Firm has submitted copy of GMP certificate of M/s Jiangsu
Yongan Pharmaceutical Co., Ltd. China (Certificate #
Approval of API/ DML/GMP certificate JS20160548) issued by Jiangsu Food and Drug Administration.
4 of API manufacturer issued by The certificate is valid till 3-3-2021
regulatory authority of country of origin Firm has submitted copy of GMP certificate of M/s Wanbury
Limited India (Certificate # 3083/Stores/2019). The certificate is
valid till 06-02-2022.
Firm has submitted copy of vendor evaluation report of
Mechanism for Vendor pre-
5 Empagliflozin and Metformin HCl, filled and signed by technical
qualification
persons of the firm.
Certificate of analysis of the API,
Firm has submitted COA of API, reference standard and impurity
6 reference standards and impurity
standards.
standards
Documents for the procurement of Firm has submitted documents for procurement of excipients used
7
excipients used in product development in formulation of applied product.
List of qualified staff involved in Firm has provided list of qualified staff of product development
8 product development with relevant section and R&D Analytical Laboratory comprising of 43
experience qualified staff.
Production Data
Authorized Protocols/SOP for the
Firm has submitted authorized stability protocols / SOP for
9 development & stability testing of trial
development and stability testing of trial batches.
batches
Complete batch manufacturing record
Firm has submitted copy of Batch Manufacturing Record for all
10
of three stability batches the three stability batches.
Firm has provided following remaining quantities for each batch:
Record of remaining quantities of 489DS01 : 280 Tablets
11
stability batches 489DS02 : 298 Tablets
489DS03 : 298 Tablets
QA/QC Data
Record of Digital data logger for
temperature and humidity monitoring of Firm has submitted copies of data logger record for stability
12
stability chambers (real time and chambers with real time and accelerated stability testing.
accelerated)
Method used for analysis of API along Firm has submitted COA and method of analysis of Empagliflozin
13
with COA. and Metformin HCl.
Method used for analysis of FPP &
Firm has submitted copy of method of analysis of FPP and
complete record of testing of stability
14 complete record of testing of stability batches along with
batches (i.e. chromatograms, lab
chromatograms, lab reports, raw data sheets etc.
reports, raw data sheets etc.)
Reports of stability studies of API from Firm has submitted stability studies reports of three batches of
15
manufacturer. Empagliflozin and Metformin HCl.
Firm has submitted analysis reports for all excipients used in
16 Analysis reports for excipients used.
product development.
Firm has submitted that same excipients has been used as used by
innovator ‘Synjardy Tablets 12.5mg + 850mg’. However, there is
17 Drug-excipients compatibility studies.
only difference in the film-coating material. Therefore, Drug-
excipients compatibility studies were not performed.

Firm has submitted data of comparative dissolution profile (in pH
18 Record of comparative dissolution data. 1.2 HCl, Acetate Buffer pH 4.5, Phosphate buffer pH 6.8) with the
innovator brand (Synjardy Tablets).
Compliance Record of HPLC software
Audit trail on testing reports for the applied product has been
19 21CFR & audit trail reports on product
submitted by the firm.
testing.
Decision: Registration Board decided to approve registration of GLARDIN-M Tablets 12.5mg + 850mg with
Innovator’s specifications by M/s Getz Pharma Pvt. Ltd 29-30, Sector 27, Korangi Industrial Area, Karachi.
Manufacturer will place first three production batches on long term stability studies throughout proposed
shelf life and on accelerated studies for six months
Sr. Name & Brand Name Type of Form, International Previous DRB
No. Address of (Proprietary Name + Initial Diary & Availability / Local Decision /
Manufacturer / Dosage Form + Strength), Date, Fee Availability Remarks
Applicant Composition, (including (if any)
Pharmacological Group, differential fee), GMP Inspection Report
Finished Product Demanded Price Date & Remarks
Specification / Pack size
123. M/s Genix GVIA-M XR Tablets Form 5 Janumet XR Tablets Deferred for
Pharma (Pvt.) Dy no 26428 50mg+500mg, submission of
Ltd. Each extended-Release 01-08-2018, M/s Merck Sharp and stability data
tablet contains: Dohme and relevant
Karachi Sitagliptin Phosphate eq. Fee: 20,000/- Firm is operating documents.
to Sitagliptin ……50mg at acceptable (M-286th )
Metformin Hydrochloride As per SRO level of GMP
……….….500mg 10’s, 14’s, 20’s, compliance as per
(Innovator’s 30’s, inspection dated
Specifications) 16-02-2018
Drug GVIA-M XR 50mg+500mg Tablets

Name of Manufacturer M/s Genix Pharma (Pvt.) Ltd.
Sitagliptin:M/s Fuxin long Rui pharmaceuticals,China
Manufacturer of API
Metformin: Abhilash Chemicals, India
API Lot No. M-20190127-D01-M06-08 & MET/B/01/19030070
Description of Pack
Alu-Alu Blister Pack
(Container closure system)
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Stability Storage Condition
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Real Time: 06 months
Accelerated: 0, 1, 2,3,4 & 6 (Months)
Frequency
Real Time: 3,6 (Months)
Batch No. 19SB-121-01 19SB-122-02 19SB-123-03
Manufacturing Date 07-2019 07-2019 07-2019
No. of Batches 03

Sr.
Documents to Be Provided Status
No.
1. COA of API Yes
Approval of API by regulatory authority of country
2. of origin or GMP certificate of API manufacturer Yes
issued by regulatory authority of country of origin.
Protocols followed for conduction of stability study
3. Yes
and details of tests.
Data of 03 batches will be supported by attested
4. respective documents like chromatograms, Yes
laboratory reports, data sheets etc.
Copy of Form 7 (License to Import drug for
clinical trial examination, test or analysis)
issued by ADC (Karachi) dated 16-04-2019, for
the import of Sitagliptin Phosphate from the M/s
Shenyang Vast Pharmatec Co Ltd, China,
manufactured by Fuxin Long Rui
Pharmaceutical CO.,Ltd has been submitted.
Copy of Commercial Invoice (invoice no.

SY190404-C) dated attested by ADC (Karachi)
dated 18-04-2019 has been submitted.
the import of Metformin HCl from the M/s
Abhilash Chemicals And Pharmaceuticals
Taminadu, India has been submitted.

GSTE-189/2018-19) dated 21-03-2019 attested
by ADC (Karachi) dated 21/03/19 has been
submitted.
All provided documents will be attested (name, sign
6. and stamp) for ensuring authenticity of data / Yes
documents.
Commitment to continue real time stability study till
7. Yes
assigned shelf life of the product.
Commitment to follow Drug Specification Rules,
8. Yes
1978.
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
REMARKS OF EVALUATOR (AD PEC-I)

1. GMP of API Certificates of the concerned manufacturer is available.
2. The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale Batches.
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide Letter
no. RA/070/20, dated 11-05-2020 and provided the following documents in conjunction with the checklist
approved by the Registration Board in its 278th Meeting:

Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
1. instant dosage form conducted during last product “WYMLY Tablets 25mg (Tenofovir Alafenamide)”,
two years. which was conducted on 06-02-2018, and was presented in
281th meeting of Registration Board held on 11-13th April,
2018.
Registration Board decided to approve registration of
WYMLY Tablets 25mg (Tenofovir Alafenamide)”, by
M/s. Genix 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 26 weeks.
Following two observations were reported in the report:
i. The HPLC software is 21CFR complaint and having
certificates of compliance by USFDA.
ii. Audit trail on the testing reports of WYMLY Tablets 25mg
(Tenofovir Alafenamide) is available.
iii. Adequate monitoring and control are available for stability
chamber. Chamber are controlled and monitored through
Documents for the procurement of API with Sitagliptin Phosphate:
2. approval from DRAP (in case of import). Copy of Commercial Invoice (invoice no. SY190404-C) dated
attested by ADC (Karachi) dated 18-04-2019 has been
submitted.
Metformin HCl: Copy of Commercial Invoice (invoice no.
GSTE-189/2018-19) dated 21-03-2019 attested by ADC
(Karachi) dated 21/03/19 has been submitted.
Documents for the procurement of reference The firm has submitted copy of commercial invoice from M/s
3. standard and impurity standards. USP 7135 English Muffin Way Frederick, MD 21704 in the
name of M/s Genix Pharma (Pvt.) Ltd, Karachi, declaring the
submission of following reference standards
Particulars Batch No. Quantity
Sitagliptin 1612903 200mg
Phosphate
Melamine 1379183 250mg
Metformin 1396309 200mg
Hydrochloride
Metformin Related 1396310 30mg
Compound A
4 Approval of API/ DML/GMP certificate of Sitagliptin: M/s Fuxin Long Rui Pharmaceuticals Co Ltd, is
API manufacturer issued by regulatory issued written confirmation for active substance exported to
authority of country of origin. EU by Liao Ning Food and Drug Administration, Peoples
republic of china.\ valid upto 27th March 2021.
Metformin: M/s Abhilash Chemicals and Pharmaceuticals Pvt

Ltd, 34/6A, Nayakkanpatti Village, Madurai North, Maduri
District (written confirmation for active substance exported to
EU issued by Ministry f health and family welfare, Central
drug standard control organization)valid upto September 2021
Mechanism for Vendor pre-qualification The firm has submitted photocopy of “SOP for Selection of
5. manufacturer for API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.

Version no: 01

Certificate of analysis of the API, reference Photocopy of COAs of Sitagliptin Phosphate + Metformin
6. standards and impurity standards Hydrochloride & working standards and impurity standards
submitted. Detail is as under
Particulars Batch no
Sitagliptin Phosphate M-20190127-D01-
M06-08
Metformin MET/B/01/19030070
Hydrochloride
working standards
Sitagliptin Phosphate 1612903
Melamine 1379183
Metformin HCl 1396309
Metformin Related 1396310
Compound A
Documents for the procurement of excipients The firm has submitted photocopy of Purchase Order/Invoices
7. used in product development? for the procurement of excipients used in product
development
List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff
8. development with relevant experience. involved in product development & regulatory affairs
comprising of 5 members.
Production Data
Authorized Protocols/SOP for the The firm has submitted photocopy of Development Protocol
9. development & stability testing of trial for Lab scale batch manufacturing of Gvia M XR
batches. 50mg/500mg Tablets. The SOP mentions the details of master
formulation & manufacturing method for both Gvia M XR
50mg/500mg. Copies of stability protocols have also been
submitted for Gvia M XR 50mg/500mg Tablets.
The master formulation and manufacturing method mentioned
in development protocol is same as that of reference product.
Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing
10. three stability batches. Record and Batch Packaging Record of the following 03
Batches:
BATCH NO BATCH SIZE MFG DATE
19SB-121-01 2500 Tablets 07-2019
19SB-122-02 2500 Tablets 07-2019
19SB-123-03 2500 Tablets 07-2019
As per submitted record all the activities of manufacturing
i.e. dispensing, granulation, drying, compression & coating
has been performed in PD lab.
11. Record of remaining quantities of stability The firm has attached Record of remaining quantities of
batches. stability batches.
QA / QC DATA
Record of Digital data logger for temperature The firm has submitted photocopies of digital printouts of
12. and humidity monitoring of stability graphical chart for Real Time and Accelerated Conditions
chambers (real time and accelerated) starting from 30-07-2019 to 29-02-2020.
Method used for analysis of API along with The firm has submitted photocopy of raw material
13. COA. specifications, raw material testing procedures and report for
Sitagliptin Phosphate USP (M-20190127-D01-M06-08) along
with chromatograms, FTIR spectrum, lab reports, raw data
sheets & COAs from manufacturer M/s Fuxin Long Rui

Pharmaceutical & supplier M/s Shenyang Vast Pharm Tech
Co Ltd.
Metformin Hydrochloride USP (batch #
MET/B/01/19030070) along with chromatograms, FTIR
spectrum, lab reports, raw data sheets & COAs from M/s
Abhilash Chemicals
Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
14. record of testing of stability batches (i.e. Testing Procedure (QC-FPNS-151 issued on 31-07-2019) for
chromatograms, lab reports, raw data sheets Gvia M XR 50mg/500mg Tablet along with Stability Study
etc.) Report of stability batches.
Reports of stability studies of API from The firm has submitted photocopy of 06 Months Accelerated
15. manufacturer. ( 40°C± 2°C, 75% ±5% )and 9 months Real Time Stability
Study (30°C+2°C, 65+5%) Data of 03 Batches of Sitagliptin
Phosphate from M/s M/s Fuxin Long Rui Pharmaceutical
The firm has submitted photocopy of 06 Months Accelerated
( 40°C± 2°C, 75% ±5% )and 5 Years Real Time Stability
Study (30°C+2°C, 65+5%) Data of 03 Batches of Metformin
HCl from M/s Abhilash Chemicals.
Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical
16. reports for all excipients used in product development of Gvia
M XR Tablets.
Drug-excipients compatibility studies. The firm has not performed Drug-excipients compatibility
17. studies and stated that the qualitative composition of their
product (Gvia M XR Tablets) is similar to that of innovator’s
product i.e. JANUMET XR Tablet and also stability studies
have not shown any incompatibility or significant
degradation.
Record of comparative dissolution data. Firm has submitted F2 factor protocol (QC/PRO/CD/33) &
18. reports dated 06-12-2019. The details of reference product &
Sample product are as follows:
feature Reference Product of M/S
product Genix Pharma
Brand name JANUMET GVIA M XR
XR Tablet Tablets
Batch No R034470 19SB-121-01
Expiry Date 07-2020 07-2021
Comparative dissolution studies have been performed in
following mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
In pH 0.1 N HCl buffer similarity factory is N/A.
In pH 4.5 Acetate buffer similarity factory is 83.288.
In pH 6.8 Phosphate buffer similarity factory is 73.818.
Compliance Record of HPLC software Firm has submitted audit trail reports of stability studies of
19. 21CFR & audit trail reports on product applied formulation.
testing.
Decision: Registration Board decided to approve registration of GVIA-M XR 50/500mg Tablets with
Innovator’s specifications by M/s Genix Pharma (Pvt.) Ltd. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on accelerated
studies for six months.

Sr. Name & Brand Name Type of Form, International Previous
No. Address of (Proprietary Name + Initial Diary & Availability / Local DRB
Manufacturer Dosage Form + Strength), Date, Fee Availability Decision /
/ Applicant Composition, (including Remarks
Pharmacological Group, differential fee), GMP Inspection (if any)
Finished Product Demanded Price Report Date &
Specification / Pack size Remarks
124. Genix Pharma GVIA-M XR Tablets Form 5 Janumet XR Tablets Deferred for
(Pvt.) Ltd. Dy no 26429 50mg+1000mg, submission
Each extended-Release 01-08-2018, M/s Merck Sharp and of stability
Karachi tablet contains: Dohme data and
Sitagliptin Phosphate eq. to Fee: 20,000/- relevant
Sitagliptin ……50mg Firm is operating documents.
Metformin Hydrochloride As per SRO at acceptable (M-286th )
USP……….….1000mg 10’s, 14’s, 20’s, level of GMP
(Innovator’s Specifications) 30’s, compliance as per
inspection dated
16-02-2018
STABILITY STUDY DATA(VI)
Drug GVIA-M XR 50mg+1000mg Tablets

Name of Manufacturer Genix Pharma (Pvt.) Ltd.
Manufacturer of API Fuxin long Rui pharmaceuticals & Abhilash Chemicals
API Lot No. M-20190127-D01-M06-08 & MET/B/01/19030070
Description of Pack
Alu-Alu Blister Pack
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Real Time: 06 months
Accelerated: 0, 1, 2,3,4 & 6 (Months)
Frequency
Real Time: 3,6 (Months)
Batch No. 18SB-118-01 18SB-119-02 18SB-120-03
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Sr.
No.
1. COA of API Yes
Approval of API by regulatory authority of country of
2. origin or GMP certificate of API manufacturer issued Yes
by regulatory authority of country of origin.
Protocols followed for conduction of stability study and
3. Yes
details of tests.
4. Yes
respective documents like chromatograms, laboratory

reports, data sheets etc.

the import of Sitagliptin Phosphate from the
M/s Shenyang Vast Pharmatec Co Ltd, China,
manufactured by Fuxin Long Rui
Pharmaceutical CO.,Ltd has been submitted.

SY190404-C) dated attested by ADC (Karachi)
dated 18-04-2019 has been submitted.
the import of Metformin HCl from the M/s
Abhilash Chemicals And Pharmaceuticals
Taminadu, India has been submitted.

GSTE-189/2018-19) dated 21-03-2019 attested
by ADC (Karachi) dated 21/03/19 has been
submitted.

6. and stamp) for ensuring authenticity of data / Yes
documents.
7. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
(AD PEC-I)
1. GMP of API Certificates of the concerned manufacturer is available.
2. The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale
Batches.
Now the firm has requested for Exemption from On-site Investigation of their submitted stability data vide Letter
no. RA/070/20, dated 11-05-2020 and provided the following documents in conjunction with the checklist
approved by the Registration Board in its 278th Meeting:
Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
1. instant dosage form conducted during last product “WYMLY Tablets 25mg (Tenofovir Alafenamide)”,
two years. which was conducted on 06-02-2018, and was presented in
281th meeting of Registration Board held on 11-13th April,
2018.
Registration Board decided to approve registration of
WYMLY Tablets 25mg (Tenofovir Alafenamide)”, by
M/s. Genix 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 26 weeks.
Following two observations were reported in the report:
i. The HPLC software is 21CFR complaint and having
certificates of compliance by USFDA.
ii. Audit trail on the testing reports of WYMLY Tablets 25mg
(Tenofovir Alafenamide) is available.
iii. Adequate monitoring and control are available for stability
chamber. Chamber are controlled and monitored through
Documents for the procurement of API with Sitagliptin Phosphate:
2. approval from DRAP (in case of import). Copy of Commercial Invoice (invoice no. SY190404-C) dated
attested by ADC (Karachi) dated 18-04-2019 has been
submitted.
Metformin HCl: Copy of Commercial Invoice (invoice no.
GSTE-189/2018-19) dated 21-03-2019 attested by ADC
(Karachi) dated 21/03/19 has been submitted.
Documents for the procurement of reference The firm has submitted copy of commercial invoice from M/s
3. standard and impurity standards. USP 7135 English Muffin Way Frederick, MD 21704 in the
name of M/s Genix Pharma (Pvt.) Ltd, Karachi, declaring the
submission of following reference standards
Particulars Batch No. Quantity
Sitagliptin 1612903 200mg
Phosphate
Melamine 1379183 250mg
Metformin 1396309 200mg
Hydrochloride
Metformin Related 1396310 30mg
Compound A
4 Approval of API/ DML/GMP certificate of Sitagliptin: M/s Fuxin Long Rui Pharmaceuticals Co Ltd, is
API manufacturer issued by regulatory issued written confirmation for active substance exported to
authority of country of origin. EU by Liao Ning Food and Drug Administration, Peoples
republic of china.\ valid upto 27th March 2021.
Metformin: M/s Abhilash Chemicals and Pharmaceuticals Pvt
Ltd, 34/6A, Nayakkanpatti Village, Madurai North, Maduri
District (written confirmation for active substance exported to
EU issued by Ministry f health and family welfare, Central
drug standard control organization)valid upto September 2021
Mechanism for Vendor pre-qualification The firm has submitted photocopy of “SOP for Selection of
5. manufacturer for API/Excipient and Procurement Procedure”,
SOP No: QA/SOP/SY/037 with effective date 07-10-2016.
Version no: 01
Copy of “Vendor’s Audit form” filled for Fuxin long
pharmaceutical company Ltd. & Abhilash Chemicals And
Pharmaceuticals Taminadu, India dated 10-02-2019Attached.
Certificate of analysis of the API, reference Photocopy of COAs of Sitagliptin Phosphate + Metformin
6. standards and impurity standards Hydrochloride & working standards and impurity standards
submitted. Detail is as under
Particulars Batch no
Sitagliptin Phosphate M-20190127-D01-M06-08
Metformin MET/B/01/19030070
Hydrochloride
working standards
Sitagliptin Phosphate 1612903
Melamine 1379183

Metformin HCl 1396309
Metformin Related 1396310
Compound A
Documents for the procurement of excipients The firm has submitted photocopy of Purchase Order/Invoices
7. used in product development? for the procurement of excipients used in product
development.
List of qualified staff involved in product The firm has submitted photocopy of List of qualified staff
8. development with relevant experience. involved in product development & regulatory affairs
comprising of 5 members.
Production Data
Authorized Protocols/SOP for the The firm has submitted photocopy of Development Protocol
9. development & stability testing of trial for Lab scale batch manufacturing of Gvia M XR
batches. 50mg/1000mg Tablets. The SOP mentions the details of
master formulation & manufacturing method for both Gvia M
XR 50mg/1000mg. Copies of stability protocols have also
been submitted for Gvia M XR 50mg/1000mg Tablets.
The master formulation and manufacturing method mentioned

in development protocol is same as that of reference product.
Complete batch manufacturing record of The firm has submitted photocopy of Batch Manufacturing
10. three stability batches. Record and Batch Packaging Record of the following 03
Batches:
BATCH NO BATCH SIZE MFG DATE
18SB-118-01 2500 Tablets 07-2019
19SB-119-02 2500 Tablets 07-2019
19SB-120-03 2500 Tablets 07-2019
As per submitted record all the activities of manufacturing i.e.
dispensing, granulation, drying, compression & coating has
been performed in PD lab.
11. Record of remaining quantities of stability The firm has attached Record of remaining quantities of
batches. stability batches
QA / QC DATA
Record of Digital data logger for temperature The firm has submitted photocopies of digital printouts of
12. and humidity monitoring of stability graphical chart for Real Time and Accelerated Conditions
chambers (real time and accelerated) starting from 30-07-2019 to 29-02-2020.
Method used for analysis of API along with The firm has submitted photocopy of raw material
13. COA. specifications, raw material testing procedures and report for
Sitagliptin Phosphate USP (M-20190127-D01-M06-08) along
with chromatograms, FTIR spectrum, lab reports, raw data
sheets & COAs from manufacturer M/s Fuxin Long Rui
Pharmaceutical & supplier M/s Shenyang Vast Pharm Tech
Co Ltd.
Metformin Hydrochloride USP (batch #
MET/B/01/19030070) along with chromatograms, FTIR
spectrum, lab reports, raw data sheets & COAs from M/s
Abhilash Chemicals

Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
14. record of testing of stability batches (i.e. Testing Procedure (QC-FPNS-148 issued on 24-07-2019) for
chromatograms, lab reports, raw data sheets Gvia M XR 50mg/1000mg Tablet along with Stability Study
etc.) Report of stability batches.
Reports of stability studies of API from The firm has submitted photocopy of 06 Months Accelerated
15. manufacturer. ( 40°C± 2°C, 75% ±5% )and 9 months Real Time Stability
Study (30°C+2°C, 65+5%) Data of 03 Batches of Sitagliptin
Phosphate from M/s M/s Fuxin Long Rui Pharmaceutical
The firm has submitted photocopy of 06 Months Accelerated
(40°C± 2°C, 75% ±5% )and 5 Years Real Time Stability
Study (30°C+2°C, 65+5%) Data of 03 Batches of Metformin
HCl from M/s Abhilash Chemicals.
Analysis reports for excipients used. The firm has submitted photocopies of its own Analytical
16. reports for all excipients used in product development of Gvia
M XR Tablets.
Drug-excipients compatibility studies. The firm has not performed Drug-excipients compatibility
17. studies and stated that the qualitative composition of their
product (Gvia M XR Tablets) is similar to that of innovator’s
product i.e. JANUMET XR Tablet and also stability studies
have not shown any incompatibility or significant
degradation.
Record of comparative dissolution data. Firm has submitted F2 factor protocol (QC/PRO/CD/33) &
18. reports dated 06-12-2019. The details of reference product &
Sample product are as follows:
feature Reference Product of M/S
product Genix Pharma
Brand name JANUMET GVIA M XR
XR Tablet Tablets
Batch No S009514 19SB-118-01
Expiry Date 11-2020 07-2021
Comparative dissolution studies have been performed in
following mediums:
i. pH 0.1N HCl buffer
ii. pH 4.5 Acetate buffer
iii. pH 6.8 Phosphate buffer
In pH 0.1 N HCl buffer similarity factory is 73.785.
In pH 4.5 Acetate buffer similarity factory is 60.862.
In pH 6.8 Phosphate buffer similarity factory is 77.184.
Compliance Record of HPLC software Firm has submitted audit trail reports of stability studies of
19. 21CFR & audit trail reports on product applied formulation
testing.
Decision: Registration Board decided to approve registration of GVIA-M XR 50/500mg Tablets with
Innovator’s specifications by M/s Genix Pharma (Pvt.) Ltd. Manufacturer will place first three

SName & Address of Brand Name Type of Form, International Previous DRB
r Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision / Remarks
. Applicant Dosage Form + Date, Fee Local (if any)
N Strength), (including Availability
o Composition, differential
. Pharmacological fee), Demanded GMP Inspection
Group, Price Report Date &
Finished Product / Pack Remarks
Specification size
125.
M/s Indus Pharma Exilant 30mg Capsule Form 5-D
Dexilant Delayed Source of pellets is
(Pvt.) Ltd. 26-27 &63- Each HPMC capsule Dairy No. 6970
Release Capsule Murli kirishna pharma
67, Sector 27, Korangi contains:- dated 19-02-
30mg of Pvt. Ltd., Maharashtra,
Industrial Area 74900., Dual Delayed 2020 USFDA approved India
Karachi. Release Rs.100,000/-
Last inspection was
Dexlansoprazole dated 19-02-
conducted on16-08-
pellets 23% eq to 2019 2017 and report
Dexlansoprazole concludes that firm
………30mg As per DPC was considered to be
operating at an
acceptable
level of
GMP compliance.
Drug Exilant 30mg Capsule
Name of Manufacturer M/s Indus Pharma (Pvt.) Ltd. 26-27 & 63-67, Sector 27, Korangi Industrial Area
74900., Karachi.
Manufacturer of API M/s Murli Krishan Pharma (Pvt) Ltd India
API Lot No. PDL/DEF-1-271118
Description of Pack Alu Alu Blister strips
Stability Storage Accelerated: 40°C ± 2°C & 75±5%RH
Condition
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 06 Months
Real Time: 06 Months
Frequency Accelerated: 0,3,6 (Month) Real
Time: 0,3,6 (Month)
Batch No. TR-01/DEXL-30 TR-02/DEXL-30 TR-03/DEXL-30
Batch Size 2,500 Capsules 2,500 Capsules 2,500 Capsules
No. of Batches 03
Sr.# Documents To Be Provided Status
1. COA of API Copy of COA (Batch # PDL/DEF-1-271118) from M/s
Murli Krishan Pharma (Pvt) Ltd India has been
submitted.

2. Approval of API by regulatory authority of country Copy of GMP Certificate for M/s Murli Krishan
of origin or GMP certificate of API manufacturer Pharma (Pvt) Ltd India issued by Food and Drug
issued by regulatory authority of country of origin. Administration, (Maharashtra state) is submitted. It is
valid until 3 April 2022.
3. Protocols followed for conduction of stability Yes

Study and details of tests.
4. Data of 03 batches will be supported by Yes
chromatograms, laboratory reports, data sheets
etc.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of Dexlansoprazole Pellets 23% w/w
attested by ADC DRAP, Karachi dated 24-01-2019.
6. All provided documents will be attested (name, Yes
sign and stamp) for ensuring authenticity of
data / documents.
7. Commitment to continue real time stability Yes
Rules, 1978.
following documents in conjunction with the checklist approved by the Registration Board in its 278 th Meeting:
Date of submission: 3-03-2019 vide diary no.3331
1Reference of last onsite panel inspection for instant Firm has referred to onsite inspection report of their
.dosage form conducted during last two years. product “Dexilant 60mg Capsules (Dexlansoprazole)”,
which was presented in 293rd meeting of Registration
board. Registration Board decided to approve registration
of above stated drug product of M/s. Indus Pharma (Pvt.)
Ltd., Karachi.
Date of inspection: 14-03-2019
According to inspection report, following points were
confirmed.
The firm has 21CFR compliant HPLC software.
The firm has audit trail reports available.
2Documents for the procurement of API with approval The firm has submitted copy of commercial invoice for the
.from DRAP (in case of import). purchase of Dexlansoprazole Pellets 23% w/w attested
by ADC DRAP, Karachi dated 24-01-2019.
4Approval of API/ DML/GMP certificate of API Copy of API/ DML/GMP Certificate for M/s Murli
.manufacturer issued by regulatory authority of country of Krishan Pharma (Pvt) Ltd India issued by Food and Drug
origin. Administration, (Maharashtra state) is submitted and is
valid till 3 April 2022.
8List of qualified staff involved in product The firm has submitted List of qualified staff involved in
.development with relevant experience. .product development department.
Production Data
9Authorized Protocols/SOP for the development & The firm has submitted photocopy of “Protocols/SOP for
.stability testing of trial batches. the Development of Dexlansoprazole Capsule 30mg”.

1Complete batch manufacturing record of three The firm has submitted photocopy of Batch
0stability batches. Manufacturing Records of following 03 Batches:
. Batch No. Batch Size Mfg. Date
TR-01/DEXL- 2500 Tablets 26-05-2019
30
TR-02/DEXL- 2500 Tablets 26-05-2019
30
TR-03/DEXL- 2500 Tablets 26-05-2019
30
1Record of remaining quantities of stability
1batches. Trial No Total no. Tablets
. Remaining
of Capsules used for Quantities
For testing of tablets
stability
testing
TR-01/DEXL-30 37packs 41 packs 96 packs

QA / QC DATA
1Record of Digital data logger for temperature and Firm has submitted photocopies of data logger record for
2humidity monitoring of stability chambers (real time and chambers used in Real Time & Accelerated stability
.accelerated) studies of applied product from 27-05-2019 to 30-11-2019
1Method used for analysis of API along with The firm has submitted photocopy of Raw Material
3COA. Specifications, Raw Material Testing Procedures along
. with COA for Dexlansoprazole DDR Pellets.
1Method used for analysis of FPP & complete record of The firm has submitted photocopy of Finished Product
4testing of stability batches (i.e. chromatograms, lab Testing Procedure for “Dexlansoprazole Capsules 30mg”
.reports, raw data sheets etc.) along with Stability Study Reports.
1Reports of stability studies of API from The firm has submitted photocopy of 06 months
5Manufacturer. Accelerated and 36 months Long term Stability Study
. Data of 03 Batches from for M/s Murli Krishan Pharma
(Pvt) Ltd India.
1Analysis reports for excipients used. No excipients is used
6
1Drug-excipients compatibility studies. N/A
.
7
1Record of comparative dissolution data. The firm has performed comparative dissolution for
.
8 “Dexlansoprazole Capsules 30mg & Dexilant Capsules
. 30mg” and concludes that both, reference product and test
product shows behavior in recommended medium (i.e,
HCI Buffer pH 1.2, Phosphate Buffer pH 5.5, Acetate
Buffer pH 4.5 and Phosphate Buffer pH7.0) and more than
85% release in Phosphate Buffer pH 7.0 medium under
similar conditions.
Hence dissolution profiles of Exilant 30mg capsule (test
product) and Dexilant 30mg capsule (reference product)
arc considered similar.

1Compliance Record of HPLC software 21CFR & The firm has submitted audit
9audit trail reports on product testing. Dexlansoprazole Capsules 30mg
.
Decision: Registration Board decided to approve registration of Exilant 30mg Capsule with Innovator’s
specifications by M/s Indus Pharma (Pvt.) Ltd. 26-27 &63-67, Sector 27, Korangi Industrial Area 74900,
Karachi. Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Sr. Name and address of Brand Name Type of Form, International

No. manufacturer / (Proprietary Name + Initial Diary & Availability / Local
Applicant Dosage Form + Strength), Date, Fee Availability
Composition, (including GMP Inspection
Pharmacological Group, differential fee), Report Date &
Finished Product Demanded Price / Remarks
Specification Pack size
126. M/s Getz Pharma Pvt. Treviamet XR Tablets 100mg Form 5D Janumet XR Tablets
Ltd + 1000mg Dy no 1803 dated 100mg + 1000mg by
29-30, Sector 27, Each extended release tablet 14-12-2012 Merck Sharp and
Korangi Industrial Area, contains: PKR 50,000/- Dohme USA.
Karachi Sitagliptin Phosphate 12-12-2012 (USFDA Approved)
Monohydrate equivalent to Demanded price is
Sitagliptin… 100mg Rs.169 per tablet. Last GMP Inspection
Metformin HCl …. 1000mg Pack of 14’s and dated 16-12-2019
30’s concluding acceptable
Oral anti-hyperglycemic level of GMP
agents compliance status
Decision of 289th
Manufacturer Specs. meeting: Deferred
for submission of
stability data

Drug Treviamet XR Tablets 100mg + 1000mg
M/s Getz Pharma Pvt. Ltd
Name of Manufacturer
29-30, Sector 27, Korangi Industrial Area, Karachi
Sitagliptin: M/s Fuxin Long Rui Pharmaceutical Co. Ltd., China
Manufacturer of API
Metformin HCl: M/s Wanbury Limited India
Sitagliptin: M-20170727-D03-M06-02, M-20180921-D04-M06-06 & M-
API Lot No. 20181222-D06-M06-03
Metformin HCl: MT18751217
Description of Pack
Alu-Alu blister packed in unit carton
Real time : 30°C ± 2°C / 75% ± 5%RH
Real time: 6 months
Time Period
Real time: 0,3,6 (months)
Frequency
Accelerated: 0,1,2,3,4,6 (months)
Batch No. 274DS03 274DS04 274DS05
Manufacturing Date 12.03.2019 20.03.2019 01.04.2019
No. of Batches 03

Date of Submission
1. COA of API Yes
Approval of API by regulatory authority of Firm has submitted copy of GMP certificate of M/s Fuxin
country of origin or GMP certificate of API Long Rui Pharmaceutical Co. Ltd., China issued by Liao
manufacturer issued by regulatory authority Ning Food and Drug Administration, China (Certificate #
of country of origin. LN180002). The certificate is valid till 27-03-2021.
2.
Firm has submitted copy of GMP certificate of M/s
Wanbury Limited India issued by Drugs Control
Administration, India (Certificate # 3083/Stores/2019). The
certificate is valid till 06-02-2022.
3. Yes
Data of 03 batches will be supported by
4. Yes
sheets etc.
Firm has submitted ADC attested invoice confirming import
of 350 Kg Sitagliptin from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., China dated 27-09-2017 for Batch
No. M-20170727-D03-M06-02, 350 Kg Sitagliptin dated
10-12-2018 for Batch No. M-20180921-D04-M06-06 and
5. 400 Kg Sitagliptin dated 25-01-2019 for Batch No. M-
Documents confirming import of API etc.
20181222-D06-M06-03.
Firm has submitted ADC attested invoice confirming
import of 1000 Kg Metformin HCl from M/s Wanbury
Limited India dated 16-01-2018 for Batch No.
MT18751217.
All provided documents will be attested
6. (name, sign and stamp) for ensuring Yes
Commitment to continue real time stability
7. Yes
Commitment to follow Drug Specification

8. Yes
Rules, 1978.
Firm has referred to onsite inspection report of their product
for Arcox (Etoricoxib) Tablets 90mg & 120mg on 17th
September, 2018 and was presented in 286th Drug
Registration Board meeting held on 14th – 16th November,
Reference of last onsite panel inspection for 2018. The case was approved and the inspection report
1 instant dosage form conducted during last confirms following points:
two years  The HPLC software is 21CFR Compliant as per record
available with the firm.
 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.
of 350 Kg Sitagliptin from M/s Fuxin Long Rui
Pharmaceutical Co. Ltd., China dated 27-09-2017 for Batch
No. M-20170727-D03-M06-02, 350 Kg Sitagliptin dated 10-
12-2018 for Batch No. M-20180921-D04-M06-06 and 400
Documents for the procurement of API with
2 Kg Sitagliptin dated 25-01-2019 for Batch No. M-20181222-
approval from DRAP (in case of import)
D06-M06-03.

of 1000 Kg Metformin HCl from M/s Wanbury Limited
India dated 16-01-2018 for Batch No. MT18751217.
Documents for the procurement of reference
3 Firm has submitted COA and invoice of reference standard.
standard and impurity standards
Firm has submitted copy of GMP certificate of M/s Fuxin
Long Rui Pharmaceutical Co. Ltd., China issued by Liao
Ning Food and Drug Administration, China (Certificate #
Approval of API/ DML/GMP certificate of
LN180002). The certificate is valid till 27-03-2021.
4 API manufacturer issued by regulatory
Firm has submitted copy of GMP certificate of M/s Wanbury
authority of country of origin
Limited India issued by Drugs Control Administration, India
(Certificate # 3083/Stores/2019). The certificate is valid till
06-02-2022.
Firm has submitted copy of vendor evaluation report of
5 Mechanism for Vendor pre-qualification Sitagliptin and Metformin HCl, filled and signed by
technical persons of the firm.
Certificate of analysis of the API, reference
6 Firm has submitted COA of API and reference standard.
standards and impurity standards
Documents for the procurement of excipients Firm has submitted documents for procurement of excipients
7
used in product development used in formulation of applied product.
Firm has provided list of qualified staff of product
List of qualified staff involved in product
8 development section and R&D Analytical Laboratory
development with relevant experience
comprising of 43 qualified staff.
Production Data
Authorized Protocols/SOP for the
Firm has submitted authorized stability protocols / SOP for
9 development & stability testing of trial
development and stability testing of trial batches.
batches
Complete batch manufacturing record of Firm has submitted copy of Batch Manufacturing Record for
10
three stability batches all the three stability batches.
Firm has provided following remaining quantities for each
batch:
Record of remaining quantities of stability
11 274DS03 : 388 Tablets
batches
QA/QC Data
Record of Digital data logger for temperature
Firm has submitted copies of data logger record for stability
12 and humidity monitoring of stability
chambers with real time and accelerated stability testing.
chambers (real time and accelerated)
Method used for analysis of API along with
13 Firm has submitted COA and method of analysis of API.
COA.
Method used for analysis of FPP & complete
Firm has submitted copy of method of analysis of FPP and
record of testing of stability batches (i.e.
14 complete record of testing of stability batches along with
chromatograms, lab reports, raw data sheets
chromatograms, lab reports, raw data sheets etc.
etc.)

Reports of stability studies of API from Firm has submitted stability studies reports of three batches
15
manufacturer. of Sitagliptin and Metformin HCl.
Firm has submitted analysis reports for all excipients used in
16 Analysis reports for excipients used.
product development
Firm has submitted that same excipients has been used as
used by innovator ‘Janumet XR Tablets 100mg + 1000mg’.
17 Drug-excipients compatibility studies. However, there is only difference in the film-coating
material. Therefore, Drug-excipients compatibility studies
were not performed.
Firm has submitted data of comparative dissolution profile
18 Record of comparative dissolution data. (in Phosphate buffer pH 6.8) with the innovator brand
(Janumet XR Tablets).
Compliance Record of HPLC software
Audit trail on testing reports for the applied product has been
19 21CFR & audit trail reports on product
testing.
Decision: Registration Board decided to approve registration of Treviamet XR Tablets 100mg + 1000mg
with Innovator’s specifications by M/s Getz Pharma Pvt. Ltd 29-30, Sector 27, Korangi Industrial Area,
Karachi.Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.
Sr. Name & Address Brand Name (Proprietary Type of Form, International Previous DRB
No. of Manufacturer Name + Dosage Form + Initial Diary & Availability / Local Decision /
/ Applicant Strength), Composition, Date, Fee Availability Remarks
Pharmacological Group, (including (if any)
Finished Product differential fee), GMP Inspection
Specification Demanded Price Report Date &
/ Pack size Remarks
127. M/s Wilshire Diamant 10 mg tablet Form-5-D Jardiance Tablets
Laboratories Each film coated tablet Dy. No: 1363 (USFDA Approved)
(Pvt.) Ltd. 124/1, contain: Dated. 10/3/2016
Quaid-e-Azam Empagliflozin …10 mg Rs.50,000/- Last inspection was
Industrial Area, (Sodium-glucose (10/March/2016) conducted on 08-08-
Kot Lakhpat, co-transporter 2 (SGLT2) 1’s.., As per SRO 2019 and report
Lahore inhibitors) 5’s.. As per SRO concludes that firm was
Manufacturer’s 10’s. As per SRO considered to be
Specifications. 20’s.., As per operating at an
SRO acceptable level of
30’s.. As per SRO GMP compliance.
STABILITY50’s. As perDATA
STUDY SRO (VI)
Drug Diamant 10mg Tablet

Name of Manufacturer M/s Wilshire Laboratories (Pvt.) Ltd. 124/1, Quaid-e-Azam Industrail Area, Kot Lakhpat,
Lahore
Manufacturer of API Empagliflozin : Zheiiang Hongyuan Pharmaceutical Co. Ltd, Chem and API Industrial
Zone, Linhai, Zhejiang, China
API Lot No. Empagliflozin: 20170401
Description of Pack 2x10’s Tablets in Alu Alu and Aluminium Foil
Stability Storage Real time : 30°C ± 2°C / 75% ± 5% RH

Condition Accelerated: 40°C ± 2°C / 75% ± 5% RH
Frequency Accelerated: 0,1, 2,3, 4, 6 (Month)
Real Time: 0,3,6, 9, 12, 18, 22 (Months)

Batch No. T001 T002 T003
Batch Size 0.45 kg 0.45 kg 0.45 kg
No. of Batches 03
Date of Submission 13/12/18 (Dy. No. 12526)
1. COA of API Yes
Lot no. 20170401
DOM:12-04-2017
Assay(anhy.): 99.8%
2. Approval of API by regulatory authority of Empagliflozin: Copy of GMP certificate issued to M/s
country of origin or GMP certificate of API Zhejiang Hongyun pharmaceuticals co. Ltd, The said
manufacturer issued by regulatory authority of certificate has been issued by Taizhou Drug
country of origin. Administration.
Zhejiang Hongyuan Pharmaceutical Co. Ltd. Issued by
China Food and Drug Administration China.
Firm has copy of a statement that Zhejiang Hongyuan
Pharmaceutical Co. Ltd., is sub company of Zhejiang
Material industry chemical group Co. Ltd.
The GMP certificate bearing number ZJ20130070 has
been verified from CFDA database that mentions bulk
material; Empagliflozin
4. Data of 03 batches will be supported by attested Yes
5. Documents confirming import of API etc. Empagliflozin along with working standard and all
impurity standards: Copy of approval of Import of
Empagliflozin by ADC DRAP Lahore along with DHL
is attached..
Invoice No. 30178567
Dated: 18-05-2017
Quantity: 0.535 Kg
DOM: 12-04-2017
6. All provided documents will be attested (name, sign and Yes
stamp) for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till Yes
8. Commitment to follow Drug Specification Rules, Yes
1978.

1. Reference of last onsite panel inspection for instant Firm has referred to onsite inspection report of their
dosage form conducted during last two years. product “Velbuvir i.e., Sofosbuvir…400mg &
Velpatasvir……100
mg”, which was presented in 292nd meeting of Registration
board. Registration Board decided to approve registration
of above stated drug product of M/s. Wilshire Laboratories
(Pvt) Ltd, Lahore
Date of inspection: 23.05.2019.
2. Documents for the procurement of API with The firm has submitted copy of approval of Empagliflozin
approval from DRAP (in case of import). Import by ADC DRAP Lahore along with DHL invoice is
attached.
3. Documents for the procurement of reference The firm has document confirming the imported
standard and impurity standards. Empagliflozin (API) with working Reference standard of
the API and all impurity Standard.
4. Approval of API/ DML/GMP certificate of API Copy of API/ DML/GMP Certificate for M/s Zhejiang
manufacturer issued by regulatory authority of Hongyun pharmaceuticals co. Ltd, issued by Taizhou Drug
country of origin. Administration, is submitted.
5. Mechanism for Vendor pre-qualification The firm has submitted documents regarding supplier
evaluation checklist.
6. Certificate of analysis of the API, reference Copy of COA of Empagliflozin (Batch # 20170401) from
standards and impurity standards M/s Zhejiang Hongyun pharmaceuticals co. Ltd, China,
COA of reference standards and impurity standards
submitted
7. Documents for the procurement of excipients The firm has submitted photocopy of Commercial
used in product development? invoices/COAs of formulation
of applied product
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved
development with relevant experience. in product development department.
Production Data
9. Authorized Protocols/SOP for the development & The firm has submitted photocopy of “Protocols/SOP
stability testing of trial batches. for the Development of Empagliflozin 10mg Film Coated
Tablet” &
stability testing of trial batches.
10. Complete batch manufacturing record of three The firm has submitted photocopy of Batch
stability batches. Manufacturing Records of following 03 Batches:
T001 0.450 kg (83 03/18
Packs)
T002 0.450 kg (83 03/18
Packs)
T003 0.450 kg (83 03/18
Packs)
11. Record of remaining quantities of stability
batches.

T001 186 NIL
T002 186 NIL
T003 187 NIL
187
187
187
pack
s
QA / QC DATA 96
pack
12. Record of Digital data logger for temperature and Firm has submitted photocopies of data logger record for
s
humidity monitoring of stability chambers (real time chambers used in Real Time & Accelerated stability
and accelerated) studies of applied product of initial six months.
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material
COA. Specifications, Raw Material Testing Procedures along
with COA for API i.e., Empagliflozin
14. Method used for analysis of FPP & complete record The firm has submitted photocopy of Finished Product
of testing of stability batches (i.e. chromatograms, Testing Procedure for “Diamant 10mg Tablet” along with
lab reports, raw data sheets etc.) Stability Study Reports.
15. Reports of stability studies of API from The firm has submitted photocopy of 06 months
Manufacturer. Accelerated and 06 months Long term Stability Study Data
of 03 Batches (Z1215-170601, Z1215-170602 and Z1215-
170603) from for M/s Zhejiang Hongyun pharmaceuticals
co. Ltd, China,
16. Analysis reports for excipients used. Lactose SD/DT, Microcrystalline Cellulose (Avicel 102),
Hydroxy propyl cellulose, Crossceramellose Sodium,
Aerosil 200, Magnesium Sterate. TC-117-220001
Yellow, RO Water,
17. Drug-excipients compatibility studies. N/A
18. Record of comparative dissolution data. The firm has performed comparative dissolution for
“Diamant 10mg Tablet & Jardiance 10mg Tablet (Eli
Lilly)” and concludes that both, reference product and test
product show behavior in recommended medium (i.e,
buffer pH 6.8, buffer pH 4.5, 0.1N HCl and Water. Hence
dissolution profiles of Jardiance 10mg Tablet (reference
product) and Diamant 10 mg Tablet (test product) arc
considered similar.
19. Compliance Record of HPLC software 21CFR & The firm has submitted audit trail reports of
audit trail reports on product testing. Diamant 10mg Tablet.
Remarks of the Evaluator(VI):The firm has submitted 6 months accelerated and 22 months real time stability
studies data of 3 batches.
Decision: Deferred for submission of valid GMP certificate of API manufacturer from concerned regulatory
authority of the country of origin as submitted GMP certificate is not from provincial or federal authority.

Sr. Name & Brand Name Type of Form, International Previous DRB
No. Address of (Proprietary Name + Initial Diary & Availability / Decision /
Manufacture Dosage Form + Date, Fee (including Local Availability Remarks
r / Applicant Strength), differential fee), (if any)
Composition, Demanded Price GMP Inspection
Pharmacological / Pack size Report Date &
Group, Remarks
Finished Product
Specification
128. M/s Wilshire Diamant 25 mg tablet Form-5-D Jardiance tablet 25 mg
Laboratories Each film coated tablet Dy. No: 1362 by M/s Boehringer
Pvt Ltd. 124/1, contain: Dated. 10/3/2016 Ingelheim (USFDA
Quaid-e-Azam Empagliflozin …25mg Rs.50,000/- Approved).
Industrial (Sodium-glucose co- (10/March/2016) Last inspection was
Estate, Kot transporter 2 (SGLT2) 1’s.., As per SRO conducted on 08-08-
Lakhpat, inhibitors) 5’s.. As per SRO 2019 and report
Lahore. Manufacturer’s 10’s. As per SRO concludes that firm
Specifications. 20’s.., As per SRO was considered to be
30’s.. As per SRO operating at an
50’s. As per SRO acceptable level of
GMP compliance
Drug Diamant 25 mg tablet

Name of Manufacturer M/s Wilshire Laboratories Pvt Ltd. 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat,
Lahore.
Manufacturer of API Empagliflozin : M/s Zhejing materials industry chemical group co. Ltd. 25 floor tower A,
Zhongda plaza, Zhongshan road, Hangzhou china
Description of Pack 2x10’s Tablets in Alu Alu and Aluminium Foil
(Container closure
system)
Frequency Accelerated: 0,1, 2,3, 4, 6 (Month)
Real Time: 0,3,6, 9, 12, 18, 22 (Months)
No. of Batches 03
Date of Submission 13/12/18 (Dy. No. 12527)
1. COA of API Yes.
2. Approval of API by regulatory authority of country Empagliflozin: Copy of GMP certificate issued to M/s
of origin or GMP certificate of API manufacturer Zhejing Hongyun pharmaceuticals co. Ltd, The said
issued by regulatory authority of country of origin. certificate has been issued by Taizhou city no Zhejiang
province

is attached..
Dated: 18-05-2017
Quantity: 0.535 Kg
DOM: 12-04-2017
6. All provided documents will be attested (name, sign Yes

and stamp) for ensuring authenticity of data /
documents.

Rules, 1978.
Date of submission: 28-11-2019 vide diary no. -------
Velpatasvir……100mg”, which was presented in 292nd
meeting of Registration board. Registration Board
decided to approve registration of above stated drug
product of M/s. Wilshire Laboratories (Pvt) Ltd, Lahore
2. Documents for the procurement of API with The firm has submitted copy of approval of
approval from DRAP (in case of import). Empagliflozin Import by ADC DRAP Lahore along
with DHL invoice is attached.
standard and impurity standards. Empagliflozin (API) with working Reference standard of
the API and all impurity Standard.
manufacturer issued by regulatory authority of Hongyun pharmaceuticals co. Ltd, issued by Taizhou
country of origin. Drug Administration, is submitted.
6. Certificate of analysis of the API, reference Copy of COA of Empagliflozin (Batch # 20170401)
standards and impurity standards from M/s Zhejiang Hongyun pharmaceuticals co. Ltd,
China, COA of reference standards and impurity
standards submitted
of applied product

Production Data
stability testing of trial batches. for the Development of Empagliflozin 25 mg Film Coated
Tablet” &
T001 0.450 kg (83 Packs) 03/18
T002 0.450 kg (83 Packs) 03/18
T003 0.450 kg (83 Packs) 03/18

batches. Trial No Total no. Tablets
Remaining of Tablets used for Quantities
st ability
t esting
T001 600 600 NIL
T002 450 450 NIL NIL
T003
T003 360 360 NIL
QA / QC DATA NIL
humidity monitoring of stability chambers (real time chambers used in Real Time & Accelerated stability NIL
with COA for Empagliflozin
of testing of stability batches (i.e. chromatograms, Testing Procedure for “Diamant 25 mg Tablet” along with
lab reports, raw data sheets etc.) Stability Study Reports.
Manufacturer. Accelerated and 6 months Long term Stability Study Data
of 03 Batches (Z1215-170601, Z1215-170602 and Z1215-
170603) from for M/s Zhejiang Hongyun pharmaceuticals
co. Ltd, China,
16. Analysis reports for excipients used. Lactose SD/DT, Microcrystalline Cellulose (Avicel
102), Hydroxy propyl cellulose, Crossceramellose
Sodium, Aerosil 200, Magnesium Sterate. TC-117-
220001 Yellow, RO Water,
“Diamant 25mg Tablet & Jardiance 25mg Tablet (Eli
Lilly)” and concludes that both, reference product and test
product show behavior in recommended medium (i.e,
buffer pH 6.8, buffer pH 4.5, 0.1N HCl and Water.
Hence dissolution profiles of Jardiance 25mg Tablet
(Reference product) and Diamant 25 mg Tablet (Test
product) arc considered similar.

audit trail reports on product testing. Diamant 25mg Tablet.
Remarks of the Evaluator: (VI)The firm has submitted 6 months accelerated and 22 months real time stability studies
data of 3 batches.
Sr. Name & Brand Name (Proprietary Type of Form, International Previous
No Address of Name + Dosage Form + Initial Diary & Availability / Local DRB
. Manufacturer / Strength), Composition, Date, Fee Availability Decision /
Applicant Pharmacological Group, (including Remarks
Finished Product differential fee), GMP Inspection (if any)
Specification Demanded Report Date &
Price Remarks
/ Pack size
129. M/s Wilshire Diamant-M 5 mg/500 mg Form-5-D SYNJARDY TABLET

Laboratories (Pvt.) Tablet Dy. No: ---- 5MG/500MG (USFDA
Ltd. 124/1, Quaid- Each film coated tablet Dated. Approved)
e-Azam Industrial contain: 22-10-2018
Area, Kot Empagliflozin …5 mg Rs.50,000/- Last inspection was
Lakhpat, Lahore (Sodium-glucose (12/10/2018) conducted on 08-08-2019
co-transporter 2 (SGLT2) 1’s.., As per SRO and report concludes that
inhibitors) 5’s.. As per SRO firm was considered to be
Metformin HCl…..500 mg 10’s. As per SRO operating at an
Manufacturer’s 20’s.., As per acceptable level of GMP
Specifications. SRO compliance.
30’s.. As per
SRO
50’s. As per SRO

Drug Diamant-M 5 mg/500 mg Tablet
Lahore
Metformin HCl:
IPCA Laboratories Ltd, 48 Kandivali Industrial Estate, Madhya Pradesh
Metformin HCl: 6417ML2RMI
Description of Pack 3 x10’s Tablets in Alu Alu and Aluminium Foil
(Container closure
system)
Frequency Accelerated: 1, 2,3, 4, 6 (Month)
Real Time: 3,6, 9, 12, 18, 24 (Months)

No. of Batches 03
Date of Submission 10/01/2020 (__________)
1. COA of API Empagliflozin: Yes
Lot no. 20170401
DOM:12-04-2017
Assay(anhy.): 99.8% from Zheiiang Hongyuan
Pharmaceutical Co. Ltd, submitted
Metformin HCl: Yes
Lot no. 6417ML2RMI
DOM: Dec-2016
Assay(anhy.): 99.5 % from IPCA Labs submitted
of origin or GMP certificate of API manufacturer Zhejiang Hongyun pharmaceuticals co. Ltd, The said
issued by regulatory authority of country of origin. certificate has been issued by Taizhou Drug
Administration.
Metformin HCl: Copy of GMP certificate issued to
M/s IPCA Labs Ltd. The said certificate has been issued
by Licensing Authority Food & Drug Administration
Madhya Pradesh, India
laboratory reports, data sheets
is attached.
Dated: 18-05-2017
Quantity: 0.535 Kg
DOM: 12-04-2017
Metformin HCl along with working standard and all
impurity standards:.The firm has submitted copy of
commercial invoice for the purchase of Metformin HCl
attested by ADC DRAP, Lahore dated 02-01-2017
documents.
Rules, 1978.
Date of submission: 10-01-2020 vide diary no.
mg”, which was presented in 292nd meeting of
Registration board. Registration Board decided to approve
registration of above stated drug product of M/s. Wilshire
Laboratories (Pvt) Ltd, Lahore
2. Documents for the procurement of API with The firm has submitted copy of commercial invoice &
approval from DRAP (in case of import). DHL for the purchase of Empagliflozin along with Copy
of approval of Import of Empagliflozin by ADC DRAP
Lahore is attached. ADC Lahore DRAP attested
Commercial invoice of Metformin HCl has also been
submitted.
standard and impurity standards. Empagliflozin & Metformin HCl (API), working
Reference standard of the API and all impurity Standard.
country of origin. Drug Administration, and GMP Certificate for IPCA Labs
Ltd issued by Licensing Authority Food & Drug
Administration Madhya Pradesh is submitted.
standards submitted
Copy of COA of Metformin HCl (Lot # 6417ML2RMI)
from M/s IPCA Labs Ltd, India COA of reference
standards and impurity standards submitted
of applied product
Production Data
stability testing of trial batches. for the Development of Diamant-M 5 mg/500 mg Film
Coated Tablet” & stability testing of trial batches.
T001 1.5 kg 1/18
T002 1.5 kg 1/18
T003 1.5 kg 1/18

st ability
t esting
T001 600 46
T002 600 46 1744
T003 600 46
1711
1743
p
a
QA / QC DATA c
k
s
9
6
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material p
a
with COA for API i.e., Empagliflozin & Metformin HClc
14. Method used for analysis of FPP & complete record The firm has submitted photocopy of Finished Product k
of testing of stability batches (i.e. chromatograms, lab Testing Procedure for “Diamant-M 5 mg/500 mg Tablet”s
reports, raw data sheets etc.) along with Stability Study Reports.
Manufacturer. Accelerated and 06 months Long term Stability Study
Data of 03 Batches (Z1215-170601, Z1215-170602 and
Z1215-170603) from M/s Zhejiang Hongyun
pharmaceuticals co. Ltd, China, for Empagliflozin. Also
submitted photocopy of 06 months Accelerated and 60
months Long term Stability Study Data of 03 Batches
(9002ML2RMI, 9003ML2RMI, 9004ML2RMI,) from
M/s IPCA Labs Ltd, India for Metformin HCl.
16. Analysis reports for excipients used. Copovidone, Starch, Aerosil, Magnesium Stearate, TC-
117-220002 Yellow, RO water
“Diamant-M 5.0mg/500mg Tablets Wilshire Pharma) &
(Synjardy 5.0mg/500mg Tablets – Eli-Lilly) exhibited
Similar Dissolution Profile in all dissolution medium 0.1N
HCl, Buffer pH - 4.5, Buffer pH 6.8 and Water. So Both
Products are equivalent in nature of Content Release
pattern “In Vitro Comparative Dissolution Studies’ has
performed successfully.
audit trail reports on product testing. Diamant-M 5 mg/500 mg Tablet
Remarks of the Evaluator: (VI) The firm has submitted 6 months accelerated and 18 months real time stability
studies data of 3 batches.

Sr. Name & Brand Name (Proprietary Type of Form, International Previous
No Address of Name + Dosage Form + Initial Diary & Availability / Local DRB
. Manufacture Strength), Composition, Date, Fee Availability Decision /
r / Applicant Pharmacological Group, (including Remarks
Finished Product differential fee), GMP Inspection Report (if any)
Specification Demanded Price Date & Remarks
/ Pack size
130. M/s Wilshire Diamant-M 5 mg/1000 mg Tablet Form-5-D SYNJARDY TABLET

Laboratories Each film coated tablet contain: Dy. No: ---- 5MG/1000MG (USFDA
(Pvt.) Ltd. Empagliflozin …5 mg Dated. Approved
124/1, Quaid-e- (Sodium-glucose 22-10-2018
Azam Industrial co-transporter 2 (SGLT2) Rs.50,000/- Last inspection was
Area, Kot inhibitors) (12/10/2018) conducted on 08-08-2019
Lakhpat, Metformin HCl…..1000 mg 1’s.., As per SRO and report concludes that
Lahore Manufacturer’s 5’s.. As per SRO firm was considered to be
Specifications. 10’s. As per SRO operating at an acceptable
20’s.., As per level of GMP
SRO compliance.
30’s.. As per SRO
50’s. As per SRO
Drug Diamant-M 5 mg/1000 mg Tablet

Lahore
Metformin HCl:
IPCA Laboratories Ltd, 48 Kandivali Industrial Estate, Madhya Pradesh
(Container closure
system)
Real Time: 3,6, 9, 12, 18, 24 (Months)
No. of Batches 03
Date of Submission 07/01/2020 (____________)

Lot no. 20170401
DOM:12-04-2017
Metformin HCl: Yes
Lot no. 6417ML2RMI
DOM: Dec-2016
Administration.
laboratory reports, data sheets
is attached.
Dated: 18-05-2017
Quantity: 0.535 Kg
DOM: 12-04-2017
documents.
Rules, 1978.

submitted.
standards submitted.
used in product development? invoices/COAs of formulation of applied product.
Production Data
stability testing of trial batches. for the Development of Diamant-M 5 mg/1000 mg Film
Coated Tablet” &stability testing of trial batches.
T001 3.0 kg 1/18
T002 3.0 kg 1/18
T003 3.0 kg 1/18

Remaining of Tablets used for
For
Quantities testing of tablets
st ability
t esting
T001 600 46 1733
T002 600 46 1742
T003 600 46 1732
QA / QC DATA
with COA for API i.e., Empagliflozin & Metformin HCl
of testing of stability batches (i.e. chromatograms, lab Testing Procedure for “Diamant-M 5 mg/10000 mg
reports, raw data sheets etc.) Tablet” along with Stability Study Reports.
“Diamant-M 5.0mg/1000mg Tablets Wilshire Pharma) &
(Synjardy 5.0mg/1000mg Tablets – Eli-Lilly) exhibited
Similar Dissolution Profile in all dissolution medium
0.1N HCl, Buffer pH - 4.5, Buffer pH 6.8 and Water. So
Both Products are equivalent in nature of Content Release
pattern “In Vitro Comparative Dissolution Studies’ has
performed successfully.
audit trail reports on product testing. Diamant-M 5 mg/1000 mg Tablet
(VI)The firm has submitted 6 months accelerated and 18 months real time stability studies data of 3 batches.

Sr. Name & Address Brand Name (Proprietary Name Type of Form, International Availability / Previous DRB
No. of Manufacturer + Dosage Form + Strength), Initial Diary & Local Availability Decision /
/ Applicant Composition, Pharmacological Date, Fee Remarks
Group, (including GMP Inspection Report (if any)
Finished Product differential fee), Date & Remarks
Specification Demanded Price
/ Pack size
131. M/s Wilshire Diamant-M 12.5 mg/500 mg Form-5-D SYNJARDY TABLET
Laboratories Tablet Dy. No: ---- 12.5 MG/500MG (USFDA
(Pvt.) Ltd. Each film coated tablet contain:
Dated. Approved)
124/1, Quaid-e- Empagliflozin …12.5 mg 22-10-2-018
Azam Industrial (Sodium-glucose Rs.50,000/- Last inspection was
Area, Kot co-transporter 2 (SGLT2) (12/10/2018) conducted on 08-08-2019
Lakhpat, Lahore inhibitors) 1’s.., As per and report concludes that
Metformin HCl…..500 mg SRO firm was considered to be
Manufacturer’s 5’s.. As per operating at an acceptable
Specifications. SRO level of GMP compliance.
10’s. As per
SRO
20’s.., As per
SRO
30’s.. As per
SRO
50’s. As per
SRO DATA(VI)
STABILITY STUDY
Drug Diamant-M 12.5 mg/500 mg Tablet

Lahore
Metformin HCl: IPCA Laboratories Ltd, 48 Kandivali Industrial Estate, Madhya Pradesh
(Container closure
system)
Real Time: 3,6, 9, 12, 18, 24 (Months)
No. of Batches 03
Date of Submission 07/01/2020 (__________)

Lot no. 20170401
DOM:12-04-2017
Metformin HCl: Yes
Lot no. 6417ML2RMI
DOM: Dec-2016
Administration.
respective documents like chromatograms, laboratory
reports, data sheets
is attached.
Dated: 18-05-2017
Quantity: 0.535 Kg
DOM: 12-04-2017
documents.
Rules, 1978.

submitted.
standards submitted
of applied product
Production Data
stability testing of trial batches. for the Development of Diamant-M 12.5 mg/500 mg
Film Coated Tablet” &
T001 1.5 kg 1/18
T002 1.5 kg 1/18
T003 1.5 kg 1/18

st ability
t esting
T001 600 46 1729

T002 600 46 1761
T003 600 46 1766

QA / QC DATA p
12. Record of Digital data logger for temperature and Firm has submitted photocopies of data logger record for a
humidity monitoring of stability chambers (real time chambers used in Real Time & Accelerated stability c
and accelerated) studies of applied product of initial six months. k
13. Method used for analysis of API along with The firm has submitted photocopy of Raw Material s
COA. Specifications, Raw Material Testing Procedures along9
with COA for API i.e., Empagliflozin & Metformin HCl6
p
14. Method used for analysis of FPP & complete record The firm has submitted photocopy of Finished Product a
of testing of stability batches (i.e. chromatograms, lab Testing Procedure for “Diamant-M 12.5 mg/500 mg c
reports, raw data sheets etc.) Tablet” along with Stability Study Reports. k
15. Reports of stability studies of API from The firm has submitted photocopy of 06 months s
“Diamant-M 12.5mg/500mg Tablets Wilshire Pharma)
& (Synjardy 12.5mg/500mg Tablets – Eli-Lilly)
exhibited Similar Dissolution Profile in all dissolution
medium 0.1N HCl, Buffer pH - 4.5, Buffer pH 6.8 and
Water. So Both Products are equivalent in nature of
Content Release pattern “In Vitro Comparative
Dissolution Studies’ has performed successfully.
audit trail reports on product testing. Diamant- M 12.5 mg/500 mg Tablets.
Decision: Deferred for submission of valid GMP certificate of API manufacturer from concerned
regulatory authority of the country of origin as submitted GMP certificate is not from provincial or federal
authority.

Agenda of Evaluator PEC-IV
Case no. 01: Deferred COVID-19 cases:

1. Azithromycin Tablet 250mg:
Composition:
Each Film coated tablet contains:
Azithromycin as dihydrate…….250mg
Availability in RRAs:
MHRA Approved
ME too status:
" Azic 250mg Tablet by M/s Nabi Qasim Reg # 055583
Specifications:
USP
Sr. Name of Brand Name with Diary no. / Pack Remarks/GMP Previous Evaluation Decision
No applicant composition Date / fee / Size / status decision (M- by PEC
. form Price 295)
132. M/s EG Aziwiz 250mg Dy.No. Renewal of DML Deferred for Firm Approved.
Pharmace Tablet 12462 dated As per recommended in clarification of submitted
uticals. Each Film Coated 03/06/2020Rs SRO inspection dated coating in revised
Plot. No. Tablet Contains: . 20,000/- 13-2-2019 manufacturing method of
13-A, Azithromycin as dated 03-06- Film coating step outline. manufacturi
Industrial Dihydrate…250mg 2020 Form 5 not mentioned in ng
Triangle, manufacturing With coating
Kahuta method step.
Road,
Islamabad
133. M/s Mycin Tablet Form-5A As per The firm was Deferred for Firm Approved.
Amros 250mg Dy.No 15354 DRAP inspected on submission of submitted
Pharmace Each tablet dated 07-03- Policy 12/05/18 application on application
uticals contains: 2019 6’s concluding approved of form 5
A-96, Azithromycin as Rs.20,000/- Good level of format of
S.I.T.E, Azithromycin Dated 07-03- cGMP. Form-5
Super dihydrate…250mg 2019 Firm applied on
Highway, Form-5A (for
Karachi imported drug)
while the drug
will locally
manufacture.
134. M/s Dynamycin 250mg Dy.No. As per Last GMP Deferred for Firm Approved.
Dynatis Tablet 11727 dated SRO inspection report revision of submitted
Pakistan Each Tablet 21/05/2020Rs dated 04-12-2018 formulation as that they
Pvt Ltd. Contains: . 20,000/- recommends grant per reference have already
Plot Azithromycin…25 dated 21-05- of DML alongwith applied as
No.710, 0mg 2020 Form 5 applicable fee per
Sundar Firm applied for innovator
Industrial uncoated tablet of product
Estate, azithromycin which is film
Raiwind rather film coated coated and
Road, azithromycin (as verified
Lahore dihydrate) from dossier

1. Azithromycin Tablet 250mg:
Composition:
Azithromycin as dihydrate…….500mg
MHRA Approved
ME too status:
" Azic 500mg Tablet by M/s Nabi Qasim Reg # 055584
Specifications:
USP
Sr. Name of composition Diary no. /

Pack Remarks/GMP Previous Evaluation by Decision
No applicant Date / fee /
Size / status decision (M- PEC
. form Price 295)
135. M/s Magns Zaracin 500mg Dy.No. 6’s GMP certificate Deferred for Firm submitted Approved
Pharmaceut Tablet 10735 dated issued on the clarification revised method
icals. Each Film Coated 12/05/2020 basis of of step of of
Plot No. 7-Tablet Contains: Rs. 20,000/- inspection film manufacturing
B, Value Azithromycin dated conducted on coating in With coating
Addition Dihydrate Eq. to 12-05-2020 01/03/2019. manufacturi step.
City Azithromycin…50 Form 5 Step of film ng I \vb tvb
Faisalabad 0mg coating not g method.
mentioned in
manufacturing
method
136. M/s EG Aziwiz 500mg Dy.No. 10’s Renewal of DML Deferred for Firm submitted Approved
Pharmaceut Tablet 12463 dated recommended in clarification revised method
icals. Each Film Coated 03/06/2020 the inspection of of
Plot. No. Tablet Contains: Rs. 20,000/- dated 13-02-2019 coating in manufacturing
13-A, Azithromycin as dated Film coating step manufacturi With coating
Industrial Dihydrate…500mg 03-06-2020 not mentioned in ngg outline. step.
Triangle, Form 5 manufacturing
Kahuta method
Road,
Islamabad
137. M/s Searle Cyzit 500mg Tablet Dy.No. 6’s GMP Certificate Deferred for Firm submitted Approved
IV Each Film Coated 11594 dated 10’s issued on 15-03- clarification revised method
Solutions Tablet Contains: 20/05/2020 2018. of of
Pvt Ltd. Azithromycin as Rs. 20,000/- Step of film coating in manufacturing
1.5 km, Dihydrate…500mg dated coating not manufacturi With coating
Manga 19-05-2020 mentioned in ngg outline. step.
Raiwind Form 5 manufacturing
Road, method
Lahore
138. M/s Macazit 500mg Dy.No. 6’s 03/05/2019 Deferred for Complete Approved
Pharma Tablet 11497 dated 10’s inspection dated. submission outline of
Lord (Pvt) Each Film Coated 19/05/2020 The panel of method of
Ltd. Tablet Contains: Rs. 20,000/- recommended method of manufacturing
12 KM, Azithromycin as dated renewal of DML. manufacturi submitted.
Lahore Dihydrate…500mg 19-05-2020 Method of n
Raod, Form 5 manufacturing g.
Layyah, not submitted
Punjab

Case no. 02 Registration applications for local manufacturing of (Human) drugs
a. New cases
139. Name and address of manufacturer / M/s Ameer & Adnan Pharmaceutical Pvt Ltd.
Applicant Plot No.47, Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Dofen 400mg Tablet
Dexibuprofen…400mg
Pharmacological Group NSIADs
Type of Form Form 5
Finished product Specifications Manufacturer’s specification
Pack size & Demanded Price 30’s : As Per SRO
Approval status of product in Reference Dexibuprofen of (MHRA approved)
Regulatory Authorities
Me-too status Obsprufen 400mg Tablet by M/s OBS
GMP status Last GMP inspection conducted on 05-01-2018 and report
concludes that firm had maintained conformance to cGMP.
IV
Remarks of the Evaluator The firm change formulation from enteric coated to film coated
with submission of fee Rs: 5000/- Deposit slip no #0788372,
Dated: 02-06-2020
Brand Name +Dosage Form + Strength Cold Rest Tablet 60mg/120mg
Composition Each bilayer Tablet Contains:
Fexofenadine HCL…60mg
Pseudoephedrine HCL…120mg
Pharmacological Group Anti-Histamine & Sympathomimetic agent.
Type of Form Form 5
Finished product Specifications USP
Pack size & Demanded Price 10’s ; As per SRO
Approval status of product in Reference TELFAST Decongestant of Sanofi Aventis ( Approved in TGA
Regulatory Authorities Austraila)
Me-too status Fexet-D 60Mg/120Mg Tablets of Getz Pharma (Pvt.) Ltd,
Karachi (Reg # 039099)
IV
Remarks of the Evaluator The firm change formulation from film coated to bilayer with
submission of fee Rs: 5000/- Deposit slip no #0788374, Dated:
02-06-2020.
As evidence of bilayer machine firm submitted purchase order,
commercial Invoice, Packing list and delivey note. Firm
submitted IQ, OQ and PQ of bi-layered tablet machine.
Decision: Deferred for submission of differential fee of Rs. 15000/- for revision of formulation.
Brand Name +Dosage Form + Strength Oricap 120mg Capsule
Orlistat…120mg
Pharmacological Group Lipase inhibitor
Type of Form Form 5
Pack size & Demanded Price 10’s, 30’s: As per SRO
Approval status of product in Reference Beacita 120mg Capsules of ( MHRA approved)
Me-too status Orlisat 120mg Capsules by M/s Merck Sharp & Dhome,
Remarks of the Evaluator IV Source of pellets: Surge laboratories
Decision: Deferred for submission of pellets data as per decision of Registration Board regarding
stability of orlistat pellets.
Brand Name +Dosage Form + Strength AD Forte Tablet 50mg/650mg
Composition Each Tablet Contains:
Orphenadrine…50mg
Paracetamol…650mg
Pharmacological Group Analgesic /Muscle Relaxant
Type of Form Form 5
Finished product Specifications Manufacturer specification
Pack size & Demanded Price 15’s, 100’s ; As per SRO
Approval status of product in Reference Not found
Me-too status Wilgesic Forte Tablets M/s Wilson’s
Pharmaceuticals
Remarks of the Evaluator IV Firm change formulation as follows:
Each Tablet Contains:
Orphenadrine…35mg
Paracetamol…450mg
With submission of fee of RS; 5000/- Deposit slip no #0788373,
Dated: 02-06-2020.
Approval status of product in Norgesic by M/s iNova
Reference Regulatory Pharmaceuticals,
Authorities Australia(TGA)
SIC Tablets of M/s Shrooq
Me-too status
Pharmaceuticals
Decision: Deferred for following:
Revision of salt form of orphenadrine in applied formulation.
Submission of differential fee of Rs. 15000/- for revision of strength of formulation.
Brand Name +Dosage Form + Strength Amtel 5/80 mg Tablet
Composition Each bilayer uncoated Tablet Contains:
Telmisartan…80mg
Amlodipine as besylate…5mg
Pharmacological Group Angiotensin-II Antagonist and Calcium
Channel Blocker
Type of Form Form- 5
Pack size & Demanded Price 10’s, 14’s, 30’s: As per SRO
Approval status of product in Reference Twynsta of USFDA Approved
Me-too status Telam 80mg/5mg Tablet of M/s Macter

Remarks of the Evaluator IV  Firm change formulation from film coated to bilayer
uncoated tablet with submission of fee of Rs: 5000/-
Deposit slip No# 0788370 dated: 02-06-2020
 As evidence of bilayer machine firm submitted purchase
order, commercial Invoice, Packing list and delivery
note. Firm submitted IQ, OQ and PQ of bi-layered tablet
machine.
Brand Name +Dosage Form + Strength Telmi-H 40/12.5mg Tablet
Telmisartan…40mg
Hydrochlorothiazide…12.5mg
Pharmacological Group Antihypertensive(Angiotensin II Receptor
Antagonist, Thiazide Diuretic
Type of Form Form 5
Pack size & Demanded Price 14’s: As per SRO
Approval status of product in Reference Micardis HCT of ( USFDA Approved)
Me-too status Cresar–H 40/12.5mg Tablet of M/S Tabros Pharma
machine.
Brand Name +Dosage Form + Strength Telmi-H 80/12.5mg Tablet
Telmisartan…80mg
Type of Form Form 5

machine.
Brand Name +Dosage Form + Strength Telmi-H 80/25 mg Tablet
Telmisartan…80mg
Hydrochlorothiazide…25mg
Type of Form Form 5
Me-too status Cresar–H 80/25mg Tablet of M/S Tabros Pharma
machine.
147. Name and address of manufacturer / M/s Aries Pharmaceuticals.
Applicant 1-W, Industrial Estate, Hayatabad, Peshawar, k.p.k
Brand Name +Dosage Form + Strength Dulox Capsule 30mg
Duloxetine HCl(17 % enteric coated pellets)eq to Duloxetine
…30mg
Pharmacological Group Serotonin and Noradrenalin reuptake inhibitors
Type of Form Form 5
Pack size & Demanded Price As per SRO
Approval status of product in Reference Cymbalta of (USFDA approved)
Me-too status Swenta 30mg Capsule by M/s Martin Dow
GMP status As above
Remarks of the Evaluator IV Source of pellets: Vision
Decision: Approved.
Applicant 1-W, Industrial Estate, Hayatabad, Peshawar, K.P.K
Brand Name +Dosage Form + Strength Dulox Capsule 60mg
Duloxetine HCl(17 % enteric coated pellets)eq to Duloxetine
…60mg
Type of Form Form 5
GMP status As above
Remarks of the Evaluator IV Source of pellets: Vision
Decision: Approved.
149. Name and address of manufacturer / M/s Jupiter Pharma.Plot No. 25, Street # S-6, National Industrial
Applicant Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Etob 90mg Tablet
Etoricoxib …90mg
Diary No. Date of R& I & fee Dy.No. 9381 dated 01-03-2019 Rs.20,000/- Dated 01-03-2019
Type of Form Form 5
Finished product Specifications Manufacture specification
Approval status of product in Reference Arcoxia 90 MG of (MHRA approved)
Me-too status Not found
concludes that firm was operating atfair level of cGMP
compliance.
IV
Remarks of the Evaluator Submitt Stability studies along with requisite documents and
differential fee.
Decision: Registration Board deferred the case for submission of stability study data as per the
guidelines provided in 278th meeting of Registration Board along differential fee.
Brand Name +Dosage Form + Strength Lide 50mg Tablet
Lacosamide….…50mg
Pharmacological Group Antiepileptic
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, 30’s :As per SRO
Approval status of product in Reference Vimpat tablet of (USFDA approved)
Me-too status Nurosa 50mg Table M/s Helix Pharma
compliance.
Remarks of the Evaluator IV
Type of Form Form 5

compliance.
Type of Form Form 5
Me-too status Atcomid 150mg Tablet M/s Atco Lab
compliance.
Type of Form Form 5
compliance.
IV
154. Name and address of manufacturer / M/s Jupiter Pharma.
Applicant Plot No. 25, Street # S-6, National Indu
Brand Name +Dosage Form + Strength Etira Tablets 250mg
Levetiracetam…250mg
Type of Form Form-5
Approval status of product in Reference Levetiracetam of (MHRA Approved)
Me-too status Letrawin Tablets 250mg of M/s Opal Laboratory

compliance.
Decision: Approved.
155. Name and address of manufacturer / M/s Jupiter Pharma. Plot No. 25, Street # S-6, National Industrial
Brand Name +Dosage Form + Strength Loram 4mg Tablet
Lornoxicam…4mg
Type of Form Form 5
Pack size & Demanded Price 5’s, 10’s, 20’s : As per SRO
Approval status of product in Reference Xefo 4 mg tablet (EMA approved)
Me-too status Lorfix 4mg Tablet of M/s AGP
compliance.
Brand Name +Dosage Form + Strength Loram 8mg Tablet
Lornoxicam…8mg
Type of Form Form 5
Pack size & Demanded Price 5’s, 10’s, 20’s, 30’s : As per SRO
compliance.
IV
Brand Name +Dosage Form + Strength Danon Tablets 8mg
Ondansetron HCl Dihydrate eq to Ondasetron…8mg
Pharmacological Group Selective serotonin 5-HT3 receptor
Antagonist
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ,; As per SRO
Approval status of product in Reference Zofran Of (USFDA Approved)
Me-too status Ondonix 8mg Tablet M/s Genix Pharma

compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Petra 325/37.5mg Tablet
Paracetamol…325mg
Tramadol Hcl…37.5mg
Pharmacological Group Analgesic
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s ; As per SRO
Approval status of product in Reference Tramacet tablet of (MHRA approved)
Me-too status Radol-P tablet of M/s Regal
Pharmaceuticals
compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Serna Tablets 50mg
Sertraline as Hcl…50mg
Pharmacological Group Anti depressant
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s; As per SRO
Approval status of product in Reference Zoloft Tablet Of (USFDA Approved)
Me-too status Ertalin 50 mg Tablets M/s Genome Pharmaceuticals
compliance.
IV
Decision: Approved
Brand Name +Dosage Form + Strength Sitamet 50/500mg Tablet
Sitagliptin as phospate monohydrate…50mg
Metformin HCL…500mg
Pharmacological Group Antihyperglycemic
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 14’s, 20’s, & 30’s: As per SRO
Approval status of product in Reference Janumet tablets of (TGA approved)
Me-too status S-Gliptin Plus Tablets of M/s Barrett Hodgson
compliance.
Brand Name +Dosage Form + Strength Sitamet 50/1000mg Tablet
Sitagliptin as phospate monohydrate…50mg
Metformin HCL…1000mg
Pharmacological Group Antihyperglycemic
Type of Form Form 5
Pack size & Demanded Price 14’s, 20’s, & 30’s: As per SRO
Approval status of product in Reference Janumet tablets of (TGA approved)
Me-too status Silmax-M 50mg/1000mg Tablet by M/s High-Q
Pharmaceuticals
compliance.
Brand Name +Dosage Form + Strength Topet Tablets 25mg
Topiramate…25mg
Pharmacological Group Antiepileptic agent
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s & 60’s: As per SRO
Approval status of product in Reference Topamax Of ( USFDA Approved)
Me-too status Lowseiz 25mg Tablets of M/S Helix Pharma
compliance.
IV
Decision: Approved.
163. Name and address of manufacturer / M/s Alliance Pharmaceuticals Pvt Ltd
Applicant 112-A, Industrial Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Mevodip Tablet 5mg/80mg
Amoldipine besylate eq to Amlodipine..…5mg
Valsartan…….80mg
Diary No. Date of R& I & fee Dy.No. 10667 dated 05-03-2019 Rs.20,000/- 05-03-2019
Pharmacological Group Antihypertensive
Type of Form Form-5
Pack size & Demanded Price 14’s, ; As per SRO
Approval status of product in Reference Approved by MHRA of UK
Me-too status Exforge Tablet of M/s Novartis Pharma (Reg.#047569)
concludes that panel recommend grant of GMP certificate.
Decision: Approved.
Brand Name +Dosage Form + Strength Mevodip Tablet 5mg/160mg
Amoldipine besylate eq to Amlodipine..…5mg
Valsartan…….160mg
Pharmacological Group Calcium antagonist/Angiotensin II antagonist
Type of Form Form 5
Approval status of product in Reference Exforge Of ( USFDA Approved)
Me-too status Co-Valzaar 5mg/160mg Tablet by M/s Vision Pharma
IV
Decision: Approved.
Brand Name +Dosage Form + Strength Difu 250mg Tablet
Diflunisal……250mg
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s: As per SRO
Approval status of product in Reference Diflunisal 250mg of MHRA approved
Me-too status Dolobis-250 Tablets of M/s Genome Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Difu 500mg Tablet
Diflunisal……500mg
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s: As per SRO
Approval status of product in Reference Diflunisal 500mg of MHRA approved
Me-too status Dolobis-500 Tablets of M/s Genome Pharmaceuticals
Decision: Approved.

Brand Name +Dosage Form + Strength D Tine 20mg Capsule
Composition Each hard gelatin capsule
contains:
Duloxetine as HCL(enteric coated pellets )…20mg
Type of Form Form 5
Pack size & Demanded Price 1 x 14’s, 2 x 14’s: As per SRO
IV
Remarks of the Evaluator Source of pellets : Vision
Decision: Approved.
contains:
Duloxetine as HCL(enteric coated pellets )…30mg
Type of Form Form 5
Remarks of the Evaluator IV Source of pellets : Vision
Decision: Approved.
contains:
Duloxetine as HCL (enteric coated pellets )…60mg
Type of Form Form 5
IV
Remarks of the Evaluator Source of pellets : Vision
Decision: Approved.
Brand Name +Dosage Form + Strength Erox 60mg Tablet
Composition Each film coatedTablet Contains:
Etoricoxib…60mg
Type of Form Form 5
Pack size & Demanded Price 1 x10’s, 2 x 10’s :As per SRO
Approval status of product in Reference ARCOXIA 60 mg film-coated tablets of (MHRA approved)
Me-too status Oraxib 60mg Table M/s. Atco Lab
IV
Brand Name +Dosage Form + Strength Febux 40mg Tablet
Febuxostat…40mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Approval status of product in Reference Uloric 40mg Tablet of (USFDA approved)
Me-too status Febuxin 40mg Tablet of M/s AGP
Brand Name +Dosage Form + Strength Febux 80mg Tablet
Febuxostat…80mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 20’s, 30’s : As per SRO
Brand Name +Dosage Form + Strength Prega 50mg Capsule
Composition Each hard gelatin capsule contains:
Pregabalin…50mg
Type of Form Form 5

Pack size & Demanded Price 1x 14’s: ; As per SRO
Approval status of product in Reference Lyrica of (USFDA approved)
Me-too status Gabica Capsule by M/s Getz Pharma
Pregabalin…75mg
Type of Form Form 5
IV
Pregabalin…100mg
Type of Form Form 5
Pack size & Demanded Price 1 x 14’s,: per SRO
Brand Name +Dosage Form + Strength Quepine 25mg Tablet
Quetiapine as Fumarate …….25mg
Pharmacological Group Antipsychotic Drugs
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s ; As per SRO
Approval status of product in Reference Seroquel of USFDA approved.
Me-too status Nubaquel 25mg Tablet of M/s Nabiqasim

Decision: Approved.
Quetiapine as Fumarate …100mg
Type of Form Form 5
Approval status of product in Reference Seroquel of USFDA approved.
Me-too status Nubaquel 100mg Tablet of M/s Nabiqasim
Decision: Approved.
Quetiapine as Fumarate …200mg
Type of Form Form 5
Approval status of product in Reference SEROQUEL (of USFDA approved)
Me-too status Quit 200mg Tablets of M/s Navegal Labs, (Reg.# 068241)
IV
Decision: Approved.
179. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207. Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Exor-H 5/160/12.5 mg Tablet
Amlodipine Besylate Eq. to Amlodipine…5mg
Valsartan…160mg
Pharmacological Group Anti-hypertensive
Type of Form Form 5
Approval status of product in Reference Exforge Hct Of ( USFDA Approved)
Me-too status Exforge Hct Of M/S Novartis Pharma
GMP status Last GMP inspection conducted on 19 -09-2018 and report
concludes that panel unanimously recommends the approval of
above 16, new/additional sections

“ Overall evaluation of the Inspection report is rated as Good
Decision: Deferred for consideration on its turn.
Brand Name +Dosage Form + Strength Lemoxol Forte Tablet
Artemether…80mg
Lumefantrine…480mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished product Specifications International Pharmacopoeia
Approval status of product in Reference WHO prequalified
Me-too status Artem Ds Plus Tablet by M/s Hilton Pharma
IV
Brand Name +Dosage Form + Strength Adzon Gel
Composition Each Gm Contains:
Adapalene…1mg (0.1% w/w)
Benzoyl Peroxide…25mg (2.5% w/w)
Pharmacological Group Retinoids for topical use in acne
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Pack size & Demanded Price 15gm, 30gm, 45gm, 60gm & 90gm ; As per SRO
Approval status of product in Reference Epiduo gel of (USFDA Approved)
Me-too status Adalen e-B Gel of M/s Pharmatec (Reg#076683)
IV
Brand Name +Dosage Form + Strength Rota-12 1000mcg Injection
Composition Each ml Ampoule Contains:
Cyanocobalamin…1000mcg
Pharmacological Group Vitamin b12
Type of Form Form 5
Pack size & Demanded Price 1ml x 100’s: As per SRO
Approval status of product in Reference Cytamen Injection 1000mcg Of (MHRA
Regulatory Authorities Approved)
Me-too status Cyfort Injection M/s Swiss Pharma

Brand Name +Dosage Form + Strength Feripro 500mg Tablet
Deferiprone…500mg
Pharmacological Group Iron Chelating Agent
Type of Form Form 5
Approval status of product in Reference FERRIPROX Of (USFDA Approved)
Me-too status Proxifer 500mg Tablets of M/s Nabiqasim Ind.(Reg# 045032)
Brand Name +Dosage Form + Strength I Rot Tablet 5mg
Folic Acid…5mg
Pharmacological Group Vitamin B9
Type of Form Form 5
Pack size & Demanded Price 10’s,20’s, 30-‘s, 100’s: As per SRO
Me-too status Zal 5mg Tablets of M/s Alsons Pharmaceuticals
Brand Name +Dosage Form + Strength Rogex 80mg Injection
Gentamycin Sulphate Eq. to Gentamycin…80mg
Pharmacological Group Aminoglycoside
Type of Form Form 5
Pack size & Demanded Price 2ml x 5’s : As per SRO
Approval status of product in Reference Gentamicin 40 mg/ml, solution for injection/infusion of MHRA
Regulatory Authorities approved

Me-too status Fengen Injection 80m of M/ Fynk Pharma Reg # 065892
Brand Name +Dosage Form + Strength Ketrox 2% w/v Lotion
Composition Each ml Contains:
Ketoconazole…20mg
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 Reference Nizoral Anti-Dandruff Shampoo by M/s McNeil Products
Regulatory Authorities Limited (MHRA Approved)
Me-too status Ketonaz Lotion by M/s Sante (Reg#073453)
Brand Name +Dosage Form + Strength Zefen 1mg Tablet
Ketotifen Hydrogen Fumarate eq to
Ketotifen……..1mg
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 Reference ZADITEN of (MHRA approved)
Me-too status Bronk 1 mg Tablet of Semos Pharmaceuticals
188. Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd.Plot No. 206 & 207. Industrial
Brand Name +Dosage Form + Strength Benmox 100mg/5ml Liquid Suspension
Mebendazole…100mg
Pharmacological Group Anthelmintics
Type of Form Form 5
Pack size & Demanded Price 30ml:: As per SRO
Approval status of product in Reference Vermox 100 mg/5 ml oral suspension of MHRA approved
Me-too status Mebizin Suspension of M/s Shrooq Pharmaceuticals
Brand Name +Dosage Form + Strength Maxotex 10mg Tablet
Metoclopramide HCl eq to Metoclopramide
(Anhydrous)…10mg
Pharmacological Group Anti-dopaminergic
Type of Form Form 5
Approval status of product in Reference Maxolon 10mg Tablets of MHRA approved
Me-too status Faclomide 10mg Tablets of M/s Farm Aid Group
Brand Name +Dosage Form + Strength Dekzol 2% w/w Oral Gel
Miconazole…20mg
Pharmacological Group Antiinfective/ Antiseptic
Type of Form Form 5
Pack size & Demanded Price 20gm: As per SRO
Approval status of product in Reference Daktarin Oral Gel of MHRA approved
Me-too status Miconit Oral Gel 2% of M/s Bio-Labs (Reg. # 054776)
IV
Brand Name +Dosage Form + Strength V-Gil 100mg Tablet
Composition Each Uncoated Tablet Contains:
Modafinil…100mg
Pharmacological Group Psychostimulants, agents used for adhd and
nootropics (Centrally acting sympathomimetics)
Type of Form Form 5
Approval status of product in Reference Modafinil 100 mg tablets of MHRA approved
Me-too status Monalert 100mg Tablet of M/s Hilton Pharma Reg # 047170)
Brand Name +Dosage Form + Strength V-Gil 200mg Tablet
Modafinil…200mg
Pharmacological Group Psychostimulants, agents used for adhd and
nootropics (Centrally acting sympathomimetics)
Type of Form Form 5
Approval status of product in Reference Modafinil 200 mg tablets of MHRA approved
Me-too status Monalert 200mg Tablet of M/s Hilton Pharma (Reg # 047171)
Brand Name +Dosage Form + Strength Vmax 250mg Tablet
Penicillamine……250mg
Pharmacological Group Anti-rehumatic
Type of Form Form 5
Approval status of product in Reference Penicillamine 250 mg film-coated tablets of MHRA approved
Me-too status Penicillamine 250mg Tablet of M/s Medisure Lab (083907)
Brand Name +Dosage Form + Strength Rifapen Forte Tablet
Rifampicin………….150mg
Isoniazid…………….75mg
Ethambutol Hcl……..275mg
Pyrazinamide…400mg
Pharmacological Group Anti-tubercular drugs
Type of Form Form 5
Approval status of product in Reference Rimstar, 150 mg/75 mg/400 mg/275 mg film- coated tablet.
Regulatory Authorities by M/s Sandoz (Swedish Medical Products Agency Approved)
Me-too status Myrin P Forte Tablets by M/s Wyeth, (Reg#027082)
Brand Name +Dosage Form + Strength Rocept Injection 440mg/20ml
Trastuzumab…440mg
Pharmacological Group Monoclonal antibody
Type of Form Form 5
Me-too status HERCEPTIN 440MG by M/s ROCHE
Remarks of the Evaluator IV  Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/
approved by the Registration Board in its 275th meeting.
Decision: Referred to Biological Drugs Division being Biological product.
Brand Name +Dosage Form + Strength V-Fox Tablet
Venlafaxine as Hcl…37.5mg
Pharmacological Group Anti-depressant
Type of Form Form 5
Pack size & Demanded Price 10’s,: As per SRO
Approval status of product in Reference EFFEXOR of (USFDA approved)
Me-too status Venlor-37.5 Tablets of M/s Genome Pharmaceuticals
GMP status Last GMP inspection conducted on 19 -09-2018 aAnd report
IV

Brand Name +Dosage Form + Strength Warfix 5mg Tablet
Warfarin Sodium…5mg
Pharmacological Group Thromboembolic conditions
Type of Form Form 5
Pack size & Demanded Price 100’s,: As per SRO
Approval status of product in Reference COUMADIN of USFDA approved
Me-too status Coagurin 5mg Tablets of M/s Atco Laboratories
IV
Brand Name +Dosage Form + Strength Zincom 20mg Tablet
Composition Each Dispersible Tablet Contains:
Zinc Sulphate Monohydrate Eq. to Elemental Zinc…20mg
Pharmacological Group Antidiarrheal
Type of Form Form 5
Approval status of product in Reference WHO prequalified Zincfant Tablet 20 mg manufactured by
Regulatory Authorities Laboratoires Pharmaceutique s Rodael -France
Me-too status Zinxus Tablet of M/s Ferozsons
Brand Name +Dosage Form + Strength Clintop Gel
Clindamycin as phosphate….10mg
Pharmacological Group Anti-infective
Type of Form Form 5
Pack size & Demanded Price 10gm, 20gm : As per SRO
Approval status of product in Reference RESIDERM 1%w/w GEL (MHRA approved)
Me-too status Sixil 10mg/g Gel of M/s Sigma Pharma (Reg # 079912)
Brand Name +Dosage Form + Strength Ropim 1mg Tablet
Ropinirole as Hcl…1mg
Pharmacological Group Anti-Parkinson/ Dopamine agonist
Type of Form Form 5
Approval status of product in Reference REQUIP of USFDA approved
Me-too status Ronirol 1mg Tablets of M/s Hilton Pharma
IV
201. Name and address of manufacturer / M/s Obsons Pharmaceuticals. 209-S, Quaid e Azam Industrial
Applicant Estate, Kotlakhpat, Lahore, Pakistan
Brand Name +Dosage Form + Strength Desdine 5mg
Desloratadine…5mg
Pharmacological Group Anti-histamine
Type of Form Form 5
Pack size & Demanded Price 10’s ; As per PRC
Approval status of product in Reference CLARINEX of USFDA approved
Me-too status Larinex Tablets of M/s Getz Pharma
GMP status GMP Inspection conducted on 12-07-2018 stated that most of
the shortcomings pointed out during last inspection had been
rectified by firm. Some advices were also given for further
improvements & up-gradations & management showed positive
approach towards compliance.
Decision: Registration Board referred the case to QA & LT Division for updated GMP status of the
firm.
202. Name and address of manufacturer / M/s Medisure Laboratories Pakistan Pvt Ltd.
Applicant A-115, S.I.T.E, Super Highway, Karachi, Pakistan
Brand Name +Dosage Form + Strength Colistat 2 Million IU Powder for Solution for Injection
Colistimethate Sodium…2 Million IU
Diary No. Date of R& I & fee Dy.No 8526 dated 26-02-2019 Rs.20,000 Dated 25-02-2019
Pharmacological Group Antibiotic
Type of Form Form 5
Approval status of product in Reference COLOMYCIN 2 million International Units (IU) of MHRA
Me-too status Coliject Injection. Of M/s GEOFMAN,(Reg # 035086)
Remarks of the Evaluator  Stability studies required.

guidelines provided in 278th meeting of Registration Board.
203. Name and address of manufacturer / M/s Mediate Pharmaceutical Pvt Ltd.Plot No. 150-151, Sector
Applicant 24, Korangi Industrial Area, Karchi, Pakistan
Brand Name +Dosage Form + Strength Medforge 5/80/12.5mg Tablet
Valsartan…80mg
Pharmacological Group Anti-hypertension
Type of Form Form-5
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.
DRAP (generic / me-too status) along with registration number,
 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.
204. Name and address of manufacturer / M/s Mediate Pharmaceutical Pvt Ltd. Plot No. 150-151, Sector
Valsartan…160mg
Type of Form Form-5
Approval status of product in Reference Exforge HCT 10/160/12.5 by Novartis (USFDA)
Me-too status Exforge HCT By Novartis (Reg. No. 069548)
Decision: Approved.
Valsartan…160mg
Type of Form Form-5
Decision: Approved.
Valsartan…160mg
Type of Form Form-5
Decision: Approved.
Brand Name +Dosage Form + Strength SPA Med 40mg/2ml Injection
Drotaverine Hcl…40mg
Pharmacological Group Antispasmodic
Type of Form Form-5
Pack size & Demanded Price 2ml : As per SRO
Approval status of product in Reference Three European countries Bulgaria, Romania,
Regulatory Authorities Hungary
Me-too status Hi-Spa 40mg/2ml Injection of M/s Helix
concludes firm was considered to be operating at an
acceptable level of good compliance with GMP guidelines
Decision: Approved.
Brand Name +Dosage Form + Strength Mexodine 30mg/5ml

Pharmacological Group Antihistamine
Type of Form Form 5
Finished product Specifications Manufacturers specifications
Approval status of product in Reference USFDA apprpoved
Me-too status Aloc 30mg/5ml Susp of M/s Bosch
Brand Name +Dosage Form + Strength Merbinamed Tablet 135mg
Composition Each film coat Tablet Contains:
Mebeverine Hcl…135mg
Pharmacological Group Anticholinergics
Type of Form Form 5
Finished product Specifications BP
Approval status of product in Reference Mebeverine hydrochloride 135 mg of MHRA approved
Me-too status Mevos Tablets 135mg by M/s. Dyson Research Laboratories .
Decision: Approved.
210. Name and address of manufacturer / M/s Seraph Pharmaceuticals. Plot No. 210, Industrial Triangle,
Brand Name +Dosage Form + Strength Cefipod DS 100mg/5ml
Cefpodoxime Proxetil eq to Cefpodoxime ……100mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form 5
Pack size & Demanded Price 50ml,,, 100ml; ; As per PRC
Approval status of product in Reference Cefpodoxime proxetil 100mg / 5 ml powder for oral suspension
Regulatory Authorities of USFDA approved
GMP status GMP certificate issued on 03-07-2018.”
Brand Name +Dosage Form + Strength Clinbez Gel
Composition Each gram of gel contains:
Clindamycin phosphate eq to clindamycin…10mg
(1% w/w)
Hydrous benzoyl peroxide eq to anhydrous benzoyl peroxide
…50mg (5 % w/w)
Pharmacological Group Anti-Acne Preparations For Topical Use
Type of Form Form 5
Finished product Specifications Manufacture specifications
Pack size & Demanded Price 10gm ; As per SRO
Approval status of product in Reference Duac Once Daily 10 mg/g + 50 mg/g Gel of MHRA approved
Me-too status Acnecib Gel of M/s Ciba Pharmaceuticals
IV
Brand Name +Dosage Form + Strength Flozin 10mg Tablet
Empagliflozin IH…10MG
Pharmacological Group Antidiabetic (Sodium-glucose cotransporter 2
(SGLT2) inhibitors
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s, 14’s, 28’s, 30’s, 60’s, 100’s: As per SRO
Approval status of product in Reference JARDIANCE tablets (USFDA) approved
Me-too status Empa 10mg of M/s CCL pharmaceuticals
Remarks of the Evaluator IV Submit Stability studies with requisite documents
Brand Name +Dosage Form + Strength Flozin 25mg Tablet
Empagliflozin IH…25MG
Pharmacological Group Antidiabetic (Sodium-glucose cotransporter 2 (SGLT2)
inhibitors
Type of Form Form-5
Approval status of product in Reference JARDIANCE tablets (USFDA) approved
Me-too status
IV
Remarks of the Evaluator Submit Stability studies with requisite documents
Brand Name +Dosage Form + Strength Emphomet Tablet 5/850mg
Empagliflozin…5mg
Metformin Hcl…850mg
Pharmacological Group Anti-Diabetic Drug, Sodium-Glucose Co-Transporter2 (SGLT2)
Inhibitor
Type of Form Form-5
th
Approval status of product in Reference Synjardy Tablets 5 mg/850 mg of EMA
Me-too status
Brand Name +Dosage Form + Strength Emphomet Tablet 5/1000mg
Empagliflozin…5mg
Pharmacological Group Anti-Diabetic Drug, Sodium-Glucose Co-
Transporter2 (SGLT2) Inhibitor
Type of Form Form-5
Approval status of product in Reference Synjardy Tablets 5 mg/1000 mg by Boehringer
Regulatory Authorities Ingelheim Pharmaceuticals, USFDA
Me-too status
IV
216. Name and address of manufacturer / M/s Seraph Pharmaceuticals.Plot No. 210, Industrial Triangle,
Brand Name +Dosage Form + Strength Emphomet Tablet 12.5/500mg
Empagliflozin…12.5mg
Type of Form Form-5
Approval status of product in Reference Synjardy Tablets 12.5 mg/500 mg by Boehringer
Me-too status
Brand Name +Dosage Form + Strength Emphomet Tablet 12.5/1000mg
Inhibitor
Type of Form Form-5
Approval status of product in Reference Synjardy Tablets 12.5 mg/1000 mg by
Regulatory Authorities Boehringer Ingelheim Pharmaceuticals, USFDA
Me-too status
Brand Name +Dosage Form + Strength Gentasone Cream
Composition Each gram of cream contains:
Gentamicin sulphate eq to Gentamicin…1mg (0.1% w/w)
Betamethasone valerate eq to Betamethasone…1mg (0.1% w/w)
Pharmacological Group Anti-bacterial and anti-inflammatory
Type of Form Form-5
Pack size & Demanded Price 10gm,20gm: As per SRO
Approval status of product in Reference Valiosone G cream of Canada approved
Me-too status Valigent Cream of M/s Xenon Pharmaceuticals (Reg#029705)
Brand Name +Dosage Form + Strength Gentasone H Cream
Composition Each gram of cream contains:
Gentamicin sulphate…1mg (0.1%W/W)
Hydrocortisone acetate…10mg (1% W/W)
Pharmacological Group Anti-bacterial and anti-inflammatory
Type of Form Form-5
Pack size & Demanded Price 10gm, 15gm: As per SRO
Me-too status Genta-Hc Cream of M/s Epoch Pharmaceuticals (Reg # 030854)
IV
Remarks of the Evaluator Evidence of approval of applied formulation in
declared/approved by the Registration Board in its 275th meeting
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.
Brand Name +Dosage Form + Strength Alzem Tablet 10mg
Mementine Hcl…10mg
Pharmacological Group Anti-dementia drugs
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s, 20’s, 30’s, 56’s / As per SRO
Approval status of product in Reference Ebixa 10 mg of MHRA Approved
Me-too status Memura Tablet by Pharmevo (Reg. No. 055485)
Decision: Approved.
Brand Name +Dosage Form + Strength Pirocam Gel 0.5%
Composition Each gram of gel contains:
Piroxicam…5mg (0.5% w/w)
Type of Form Form-5
Pack size & Demanded Price 20gm, 25gm / As per SRO
Approval status of product in Reference Feldene 0.5% w/w Gel. Of MHRA approved
Me-too status Pioxi Gel 0.5% of M/s Linta pharmaceuticals (Reg.# 080263)
Decision: Approved.
Brand Name +Dosage Form + Strength Biome Capsule 20/1100mg
Sodium bicarbonate…20mg
Omeprazole…1100mg
Pharmacological Group Proton pump inhibitor + Antacid
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s, 14’s / As per SRO
Approval status of product in Reference Zegerid Capsule by (USFDA Approved)
Me-too status Zoltar Insta 20mg Capsule of M/s Pharmevo
IV
Brand Name +Dosage Form + Strength Biome Capsule 40/1100mg
Sodium bicarbonate…40mg
Omeprazole…1100mg
Pharmacological Group Proton pump inhibitor + Antacid
Type of Form Form-5
Pack size & Demanded Price 7’s, 10’s, 14’s / As per SRO
Approval status of product in Reference Zegerid Capsule 40/1100mg by Santarus Inc
Regulatory Authorities (USFDA Approved)
Me-too status Faast Plus Capsule by CCL Pharma (Reg# 060325)

Brand Name +Dosage Form + Strength Dron 70mg Tablet
Alendronate Sodium Eq. to Alendronic
Acid…70mg
Pharmacological Group Bisphosphonate ( Antiosteoporotic)
Type of Form Form 5
Approval status of product in Reference Alendronic Acid 70mg of MHRA approved
Me-too status Bonafide Tablets 70mg by M/s Medisure Labs.
concludes that as per findings of the inspection recorded on
cGMP audit proforma and keeping in view the overall cGMP
compliance status of the firm in terms of plant, premises,
manufacturing, quality control, environmental facilities
provided, documentation, qualified staff employed, validation
and caliberation record evaluation, the panel unanimously
recommended the grant of cGMP certificate to the firm.
Decision:Deferred for consideration on its turn.
Brand Name +Dosage Form + Strength Aricure 50mg/5ml IV Injection
Composition Each 5ml Ampoule Contains:
Atracurium Besylate…50mg
Pharmacological Group Non depolarizing muscle relaxant
Type of Form Form 5
Approval status of product in Reference Tracrium Injection10mg/ml of MHRA approved
Me-too status Atrium Injections by M/s Searle Pakistan, Karachi (R#053342)
compliance staus of the firm in terms of plant, premises,
Decision:Deferred for consideration on its turn.
Brand Name +Dosage Form + Strength Aripine 1mg/ml Injection
Atropine Sulphate…1mg
Pharmacological Group Anticholinergic
Type of Form Form 5
Approval status of product in Reference Atropine Sulfate Injection 1mg in 1 ml of MHRA approved
Me-too status Swiss Atropine 1mg/ml Inj. of M/s Swiss Pharma (R#044290)
IV
Brand Name +Dosage Form + Strength Bamral 20mg Tablet
Bambuterol Hcl…20mg
Pharmacological Group Long acting beta adrenoceptor agonist
Type of Form Form 5
Approval status of product in Reference Bambec Tablet of (MHRA Approved)
Me-too status Long acting beta adrenoceptor agonist
Brand Name +Dosage Form + Strength Clomix 75mg Tablet
Clomipramine HCl……75mg
Pharmacological Group Antidepressant
Type of Form Form 5
Approval status of product in Reference Clomipramine HCl by sandoz ANSM france Approved
Me-too status Clomipril Tablets of M/s Libra Reg# 027816

Brand Name +Dosage Form + Strength Desatil 2.5mg/5ml Syrup
Desloratadine…2.5mg
Pharmacological Group Antiallergic
Type of Form Form 5
Approval status of product in Reference Clarinex of (USFDA approved)
Me-too status Desora Syrup by M/s S.J &G. Fazul Ellahie
Brand Name +Dosage Form + Strength Ibudex 200mg Tablet
Dexibuprofen…200mg
Pharmacological Group NSIADs
Type of Form Form 5
Pack size & Demanded Price As Per SRO
Approval status of product in Reference Dexibuprofen of (MHRA approved)
Me-too status Bekonil 200mg Tablet of M/s Martin Dow
Brand Name +Dosage Form + Strength Arinate 50mg/ml Injection
Dimenhydrinate…50mg
Type of Form Form 5
Approval status of product in Reference Dimenhydrinate Inj of Fresenius kabi, USFDA
Me-too status Dirinate Injection Each Ml Ampoule Contains:-
Dime of M/s Elite Pharma
Brand Name +Dosage Form + Strength Co-Besart 300/12.5 mg Tablet
Irbesartan…300mg
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form 5
Approval status of product in Reference AVALIDE of ( USFDA approved)
Me-too status Irbest Plus Tablets of M/s Highnoon Laboratories
IV
Brand Name +Dosage Form + Strength Ketalog 500mg/10ml Injection
Ketamine Hcl Eq. to Ketamine…500mg
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 Reference Ketalar 50 mg/ml Injection, of MHRA approved 10ml
Me-too status Katafast 500mg Injection by M/s Vision

Brand Name +Dosage Form + Strength Ketor 30mg/ml Injection
Ketorolac Tromethamine…30mg
Type of Form Form 5
Approval status of product in Reference Toradol 30mg/ml of TGA approved
Me-too status Ketopan Injection 30mg by M/s Welwrd Pharmaceuticals,
Brand Name +Dosage Form + Strength Aricain 10mg/ml Injection
Lidocaine Hcl…10mg
Pharmacological Group Local anaesthetic
Type of Form Form 5
Approval status of product in Reference Lidocaine Injection 1% w/v (MHRA approved)
Me-too status Lacain 1% Injection of M/s. Pulse Pharmaceuticals
Remarks of the Evaluator IV Firm has mentioned “ Each 1ml ampoule in some parts of form
5 and at the same time also mentioned filled volume 2ml. Firm
has clarified the volume as 2ml, however revised form 5,
applicable fee not submitted.
Brand Name +Dosage Form + Strength Co-Locor 50/12.5 mg Tablet
Losartan Potassium…50mg
Antagonist,Thiazide Diuretic)
Type of Form Form 5
Approval status of product in Reference Cozaar Comp 50 mg/12.5 mg of ( MHRA
Me-too status Lotass Plus 50mg/12.5mg of M/S Getz pharma
Brand Name +Dosage Form + Strength Prox 37.5mg CR Tablet
Composition Each Enteric Film Coated Controlled Release Tablet Contains:
Paroxetine Hcl Eq. to Paroxetine…37.5mg
Pharmacological Group Selective serotonin-reuptake inhibitors
Type of Form Form 5
Approval status of product in Reference PAXIL CR of (USFDA approved)
Me-too status Paraxyl CR M/s CCL Pharmaceuticals
Remarks of the Evaluator IV .
Brand Name +Dosage Form + Strength Arixicam IM 20mg/ml Injection
Piroxicam…20mg
Pharmacological Group Anti-rheumatic
Type of Form Form -5
Finished product Specifications Manufacturers specification
Approval status of product in Reference Approved by ANSM of France
Me-too status Salden 20mg Injection of M/s Danas Pharma (Reg.#080373)
Remarks of the Evaluator IV .
Brand Name +Dosage Form + Strength Thioside 4mg/2ml Injection
Thiocolchicoside…4mg
Pharmacological Group Skeletal Muscle Relaxant
Type of Form Form-5
Approval status of product in Reference Coltramyl Injection by M/s Sanofi Aventis
Regulatory Authorities ANSM France
Me-too status Myovi 4mg/2ml Injection by Macter Intl.(Reg. No. 058692)
IV
Remarks of the Evaluator .
Decision:Registration Board deferred the case for submission of stability study data as per the
Brand Name +Dosage Form + Strength Gliflozin Met Tablets 5/850mg
Empagliflozin…5mg
Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s, 28’s,: As per SRO
Approval status of product in Reference Synjardy Tablets 5 mg/1000 mg of EMA
Me-too status
IV

Brand Name +Dosage Form + Strength Gliflozin Met Tablets 5/1000mg
Empagliflozin…5mg
Type of Form Form-5
Approval status of product in Reference Synjardy Tablets 5 mg/1000 mg by Boehringer
Me-too status
Brand Name +Dosage Form + Strength Gliflozin Met Tablets 12.5/500mg
Type of Form Form-5
Pack size & Demanded Price 7’s,14’s, 28’s, 30’s, 100’s: As per SRO
Approval status of product in Reference Synjardy Tablets 12.5 mg/500 mg by Boehringer
Me-too status
Type of Form Form-5
Approval status of product in Reference Synjardy Tablets 12.5 mg/850 mg of EMA
Me-too status
Type of Form Form-5
Approval status of product in Reference Synjardy Tablets 12.5 mg/1000 mg by
Regulatory Authorities Boehringer Ingelheim Pharmaceuticals, USFDA
Me-too status
245. Name and address of manufacturer / M/s Fedro Pharmaceuticals Laboratories Private Limited.149-
Applicant Industrial Estate, Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Fedpro 40mg Tablets
Composition Each enteric coated tablet contains:
Pantaprazole as Sodium sesquihydrate …40mg
Pharmacological Group Proton pump inhibitor
Type of Form Form 5
Pack size & Demanded Price 14’s,; As per SRO
Approval status of product in Reference Pantoprazole 40 mg Tablet Of ( MHRA Approved)
Me-too status Pantopraz 40mg Tablet M/s Klifton Pharma,
GMP status Last GMP inspection of Fedro Pharmaceuticals conducted on
30-01-2019 and report concludes the firm rectified majority of
observations noted in the previous inspection and the
management is committed to further improve their CGMP
compliance. The firm may be considered operating in
satisfactory level of cGMP compliance
Remarks of the Evaluator The firm change formulation from while in applied formulation
Pantotprazole to Pantotprazole as sodium sesquihydrate with
submission of fee of Rs: 5000/- Deposit slip no# 0738748,
Dated: 22-07-2020
Decision: Approved.
Brand Name +Dosage Form + Strength Respedone 3mg Tablets
Risperidone…3mg
Pharmacological Group Sedative
Type of Form Form 5
Pack size & Demanded Price 10’s ,12’2, 18’s, 20’s, 30’s, 50’s: As per SRO
Approval status of product in Reference Risperdal 3mg of (MHRA approved)
Me-too status Rislet 3mg Tablet M/s. High-Q Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Respedone 4g Tablets
Risperidone…4mg
Type of Form Form 5
Pack size & Demanded Price 10’s ,12’2, 18’s, 20’s, 30’s, 50’s: As per SRO
Approval status of product in Reference Risperdal 4mg of (MHRA approved)
Me-too status Rislet 4mg Tablet M/s. High-Q Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Tizafed 2mg Tablets
Tizanidine as HCL…2mg
Pharmacological Group Skeletal Muscle relaxant
Type of Form Form 5
Approval status of product in Reference Tizanidine of MHRA approved
Me-too status Tandolax 2mg Tablet M/s High-Q Pharmaceuticals

Remarks of the Evaluator  The firm change formulation from film coated to
Deposit slip no# 0081716, Dated: 22-07-2020
Decision: Approved.
Brand Name +Dosage Form + Strength Tizafed 4mg Tablets
Tizanidine as HCL…4mg
Pharmacological Group Skeletal Muscle relaxant
Type of Form Form 5
Approval status of product in Reference Tizanidine of MHRA approved
Me-too status Tandolax 4mg Tablet M/s High-Q Pharmaceuticals
Remarks of the Evaluator  The firm change formulation from film coated to
Deposit slip no# 0559544, Dated: 22-07-2020
Decision: Approved.
250. Name and address of manufacturer / M/s The Schazoo Zaka Pvt Ltd.
Applicant Lahore Kalalwala, Zaka ur Rehman State, Plot No.1, 20-km
Lahore-Jaranwala Road, Shikhupura
Brand Name +Dosage Form + Strength Qutin XR 100mg Tablet
Composition Each extended release tablet contains:
Quetiapine as fumarate eq to Quetiapine…100mg
Type of Form Form 5
Remarks of the Evaluator  Evidence of approval of applied formulation in reference
 Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
were adopted by the Registration Board

251. Name and address of manufacturer / M/s GT Pharma Pvt Ltd.23km, Raiwind Road, Lahore
Applicant By: M/s English Pharmaceuticals Industries.
Link Kattar Bund Road, Thokar Niaz Baig, Multan Road, Lahore
Brand Name +Dosage Form + Strength Apex 40mg Injection
Omeprazole as Sodium…40mg
Pharmacological Group Proton Pump Inhibitor
Type of Form Form 5
Finished product Specifications Manufacture’s specification
Approval status of product in Reference Omeprazol 40mg injection of (MHRA approved)
Me-too status Fymezole Dry Powder Injection IV of M/s Fynk Pharma
GMP status Last GMP inspection of GT Pharma conducted on 31-01-2019
and the report concludes that the firm was found to be GMP
compliant &
Certificate of GMP Issued on 16-01-2018.
Remarks of the Evaluator  Copy of Contract manufacturing agreement attached
 Number of sections of applicant approved by Licensing
Board : 04
 Number of products already registered/approved on
contract manufacturing in the name of applicant : Nil
252. Name and address of manufacturer / M/s GT Pharma Pvt Ltd.23km, Raiwind Road, Lahore
Applicant By
M/s English Pharmaceuticals Industries.
Link Kattar Bund Road, Thokar Niaz Baig, Multan Road, Lahore
Brand Name +Dosage Form + Strength Spell 40mg Injection
Esomeprazole as Sodium…40mg
Type of Form Form 5
Approval status of product in Reference Nexium IV injection of (USFDA approved)
Me-too status Esold Injection of M/s Weather Folds Pharmaceutical
GMP status Last GMP inspection of GT Pharma conducted on 31-01-2019
and the report concludes that the firm was found to be GMP
compliant &
Certificate of GMP Issued on 16-01-2018.
Remarks of the Evaluator  Copy of Contract manufacturing agreement attached
 Number of sections of applicant approved by Licensing
Board : 04
 Number of products already registered/approved on
contract manufacturing in the name of applicant : Nil
253. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Brand Name +Dosage Form + Strength Forbec 100/6 mcg Inhaler
Composition Each Metered Dose Contains:
Beclomethasone Dipropionate…100mcg
Formoterol Fumarate…6mcg
Pharmacological Group Adrenergic in comination with corticosteriod
Type of Form Form-5
Pack size & Demanded Price 120 actuation: As per SRO
Approval status of product in Reference Fostair 100/6 micrograms per actuation
Regulatory Authorities pressurised inhalation solution of MHRA
approved
Me-too status Foster Pressurized Metered Dose Inhaler. By Chiesi
pharmaceutica
GMP status Last inspection was conducted on 10-04-2019 and report
concludes that firm is operating at an acceptable level of cGMP
compliance.
Remarks of the Evaluator IV  Complete details of container.closure system/device required.
 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.
 Deferred for confirmation of required manufacturing facility / section from Licensing
Division.
 Complete details of container closure system/device.
254. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd.44,45-B, Korangi Creek Road,
Brand Name +Dosage Form + Strength Edoban 15mg Tablet
Edoxaban Tosilate Eq. to Edoxaban…15mg
Pharmacological Group Antithrombotic agent
Type of Form Form-5
Approval status of product in Reference Lixiana 15 mg film-coated tablets of MHRA
compliance.
IV
Remarks of the Evaluator Submit Stability studies along with requisite documents.
Brand Name +Dosage Form + Strength Ercaf 1/100 mg Tablet
Ergotamine Tartrate…1mg
Caffeine…100mg
Pharmacological Group Ergot Alkaloid/ Xanthine
Type of Form Form-5
Approval status of product in Reference Cafergot of USFDA approved
Me-too status Cafergot TAB of M/s SANDOZ
compliance.
Brand Name +Dosage Form + Strength Fidox 200mg Tablet
Fidaxomicin…200mg
Pack size & Demanded Price 10’s,c 20’s, 30’s: As per SRO
Approval status of product in Reference DIFICLIR 200 mg film-coated tablets of MHRA approved
compliance.
IV
Remarks of the Evaluator Submit stability studies along with requisite documents
Brand Name +Dosage Form + Strength Talim 0.5mg Capsule
Tacrolimus…0.5mg
Pharmacological Group Immunosuppresant
Type of Form Form 5
Approval status of product in Reference Prograf of USFDA approved
Me-too status Inograf 0.5 mg capsule by Platinum Pharma (Reg.# 045490)
compliance.
Decision: Approved.
258. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd.
Applicant 44,45-B, Korangi Creek Road, Karachi, 75190,
Pakistan
Brand Name +Dosage Form + Strength Verlin 1mg Tablet
Varenicline Tartrate Eq. to Varenicline…1mg
Pharmacological Group Nicotinic acetylcholine receptor partial agonist/smoking
cessation aid
Type of Form Form 5
Approval status of product in Reference Prograf of USFDA approved
Me-too status Chantix 1.0mg Of M/S Parke Davis & Co. (Reg.# 045698)
compliance.
IV
Brand Name +Dosage Form + Strength Riocig 0.5mg Tablet
Riociguat…0.5mg
Pharmacological Group Anti hypertensive
Pack size & Demanded Price 30’s, 60’s, :As per SRO
Approval status of product in Reference Adempas of USFDA approved
GMP status Last inspection was conducted on 10-04-2019 and
report concludes that firm is operating at an
acceptable level of cGMP compliance.
IV
Brand Name +Dosage Form + Strength Pirnix 534 mg Tablet
Pirfenidone…534mg
Pharmacological Group Anti-fibrotic
Pack size & Demanded Price 7’s, 14, 21;s :As per SRO
Approval status of product in Reference Esbriet 534 mg film-coated tablets of MHRA approved
compliance.
Remarks of the Evaluator IV Submit Stability studies along with requisite documents.
Brand Name +Dosage Form + Strength Indap 10/1.25/10 mg Tablet
Perindopril Argenine………10mg
Indapamide………………..1.25mg
Amlodipine as Besylate……10mg
Pack size & Demanded Price 30, 60;s :As per SRO
Approval status of product in Reference Coverdine 5mg/1.25mg/10mg film-coated tablets of HPRA
Regulatory Authorities Ireland approved
compliance.

Decision: Deferred for submission of stability study data as per requirements of 293rd meeting of
Registration Board.
Brand Name +Dosage Form + Strength Obecol 10mg Tablet
Obeticholic Acid…10mg
Pharmacological Group Bile acid prepartions
Pack size & Demanded Price 10’s, 20, 30;s :As per SRO
Approval status of product in Reference OCALIVA 5 mg film-coated tablets of MHRA approved
compliance.
Brand Name +Dosage Form + Strength Morphate 100mg/5ml Oral Syrup
Morphine Sulphate…100mg
Pharmacological Group Opoid analgesic
Pack size & Demanded Price 15ml, 30ml, 60ml, 90ml, 120ml:As per SRO
Approval status of product in Reference Morphine Sulfate Oral Solution of USFDA approved
compliance.
 Deferred for confirmation of required manufacturing facility / section from Licensing Division.
 Registration Board deferred the case for submission of stability study data as per the guidelines
provided in 278th meeting of Registration Board.
Brand Name +Dosage Form + Strength Baclan 10mg Tablet
Baclofen…….10mg
Pharmacological Group Muscle Relaxant and antispastic
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s, 3x 10’s, As per SRO
Approval status of product in Reference Baclofen of ( MHRA approved)
Me-too status Baclin Tablets Of M/S Genome Pharmaceuticals
Remarks of the Evaluator IV Firm change formulation from film coated tablet to uncoated
tablet with submission of fee of RS: 5000/- Deposit slip no #
0553518 Dated : 28-07-2020
Decision: Approved.
Brand Name +Dosage Form + Strength Cinitax 1mg Tablet
Cinitapride as acid tartrate..…1mg
Pharmacological Group Propulsives
Type of Form Form 5
Approval status of product in Reference Cidine 1 mg Tablet of Spain approved
Me-too status Cint 1mg Tablet M/s High-Q Pharmaceutical
IV
Remarks of the Evaluator Firm change formulation from film coated tablet to uncoated
0553519 Dated : 28-07-2020
Brand Name +Dosage Form + Strength Eper 50mg Tablet
Composition Each Sugar coated Tablet Contains:
Eperisone HCl…..…50mg
Pharmacological Group Muscle Relaxant
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s, 2 x 10’s, 3 x 10’s :As per SRO
Approval status of product in Reference Myonal 50mg Tablet of PMDA Approved
Me-too status Berelax 50mg Tablet by Ray Pharma Karachi Reg# 061084
Remarks of the Evaluator IV Firm change formulation from film coated tablet to Sugar coated
tablet with submission of fee of RS: 5000/- .Deposit slip no #
0553520 Dated : 28-07-2020
Brand Name +Dosage Form + Strength Ivertin 6mg Tablet
Composition Each film coatedTablet Contains:
Ivermectin…….6mg
Pharmacological Group Semisynthetic anthelmintic agent
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s, 2 x10’s ; As per SRO
Me-too status I-Mec Tablets t of M/s Alen Pharmaceuticals
GMP status Last GMP inspection conducted on 30-08-2018 and report that
panel recommend grant of
th
GMP certificate.
Remarks of the Evaluator IV  Stromectol 6mg (Uncoated) of USFDA Discontinued
(submitted by firm)
 Evidence of approval of applied formulation in reference
Brand Name +Dosage Form + Strength Eperol 25mg Tablet
Lamotrigine…25mg
Pharmacological Group Other antiepileptics
Type of Form Form 5
Approval status of product in Reference LAMICTAL 25mg Tablets (USFDA approved)
Me-too status Epictal 25mg Tablet of M/s Bosch
Remarks of the Evaluator IV Firm change formulation from film coated tablet to uncoaed
0553521 Dated : 28-07-2020
Decision: Approved.
Lamotrigine…50mg
Type of Form Form 5
Approval status of product in Reference Lamictal 50mg (MHRA approved)
IV
0553522 Dated : 28-07-2020
Decision: Approved.
Lamotrigine…100mg
Type of Form Form 5

Approval status of product in Reference Lamictal 100mg (MHRA approved)
IV
0553523 Dated : 28-07-2020
Decision: Approved.
Brand Name +Dosage Form + Strength Zolin 600mg Tablet
Linezolid…….600mg
Pharmacological Group Oxazoldone Antibiotic
Type of Form Form 5
Pack size & Demanded Price 2 x 6’s ;As per SRO
Approval status of product in Reference Zyvox 400 mg tablet of (USFDA approved)
Me-too status Ecasil 600mg tablet by M/s Sami (Reg#066904)
Remarks of the Evaluator IV Firm change formulation from enteric coated tablet to Film
coated tablet with submission of fee of RS: 5000/- Deposit slip
no # 0553524 Dated : 28-07-2020
Brand Name +Dosage Form + Strength Artist 20mg Tablet
Telmisartan……..20mg
Diary No. Date of R& I & fee Dy.No. 10651 dated 05-03-2019 Rs.20,000/- Dated05-03-2019
Pharmacological Group Angiotensin receptor blocker
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s, 2 x 10’s : As per SRO
Approval status of product in Reference Micardis of ( USFDA Approved)
Me-too status Misar 20mg Tab by Highnoon Laboratories (Reg #065686)
IV
0553525 Dated : 28-07-2020
Decision: Approved.
Brand Name +Dosage Form + Strength Klovir 800mg Tablet
Acyclovir ……800mg
Pharmacological Group Antiviral
Type of Form Form 5
th
Approval status of product in Reference Aciclovir 800 mg Tablets of MHRA approved
Me-too status Virocyc Tablets of M/s Global Pharmaceuticals
Brand Name +Dosage Form + Strength Zovir 250mg/10ml Injection
Composition Each 10ml Vial Contains:
Acyclovir…250mg
Type of Form Form 5
Pack size & Demanded Price 1’s (10ml); As per SRO
Approval status of product in Reference Zovirax I.V. 250 mg of MHRA approved
concludes that panel unanimously
recommends the approval of above 16,
new/additional sections
Remarks of the Evaluator IV  Evidence of applied formulation/drug already approved by
number, brand name and name of firm
Brand Name +Dosage Form + Strength Zovir 500mg/10ml Injection
Acyclovir…500mg
Type of Form Form 5
Pack size & Demanded Price 1’s (20ml) ; As per SRO
Approval status of product in Reference Zovirax I.V. 500 mg of MHRA approved
Remarks of the Evaluator IV  Evidence of applied formulation/drug already approved by
Brand Name +Dosage Form + Strength Beta One Lotion 0.1%
Betamethasone valerate…0.1% w/w
Pharmacological Group Corticosteroids
Type of Form Form-5
Pack size & Demanded Price 60ml, As per SRO
Approval status of product in Reference Betnovate Lotion 0.1% w/w by (MHRA
Regulatory Authorities Approved
Me-too status Betamethasone Lotion by M/s Werrick
Pharmaceuticals, (Reg# 051176)
Brand Name +Dosage Form + Strength Bosnim 62.5mg Tablet
Bosentan Monohydrate Eq. to Bosentan ……62.5mg
Pharmacological Group Endothelin Receptor Antagonist
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, ; As per SRO
Approval status of product in Reference Tracleer of USFDA approved
Me-too status Bozpah 62.5mg Tablet of M/s Nabiqasim
Brand Name +Dosage Form + Strength Clintek Gel
Clindamycin Phosphate…12mg (1.2 % w/w)
Tretinoin…0.25mg (0.025% w/w)
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 Reference ZIANA (Gel) of USFDA approved
Me-too status Clin Gel 20g Gel of M/s Linta pharmaceuticals

Brand Name +Dosage Form + Strength Donil 5mg Tablet
Donepezil Hcl…5mg
Pharmacological Group Anticholinesterases
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s / As per SRO
Approval status of product in Reference Donepezil Hydrochloride 5 mg film-coated tablets of MHRA
Me-too status Remembrin Tablets by PharmEvo (Reg. No#045401)
IV
Brand Name +Dosage Form + Strength Donil 10mg Tablet
Donepezil Hcl…10mg
Pharmacological Group Anticholinesterases
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s / As per SRO
Approval status of product in Reference Donepezil Hydrochloride 10 mg film-coated tablets of MHRA
Me-too status Remembrin Tablets by PharmEvo (Reg. No# 045402)
Brand Name +Dosage Form + Strength Uric Tablet 120mg
Febuxostat…120mg
Pharmacological Group Antigout preparation (Non-purine xanthine oxidase Inhibitor)
Type of Form Form 5
Approval status of product in Reference ADENURIC 120 mg film-coated tablets of MHRA approved
Me-too status Gouric 120mg Tablet of M/s Pharmevo (Reg #080284)
Brand Name +Dosage Form + Strength Filget 300mcg Injection
Filgrastim…300mcg
Pharmacological Group Rcombinent G-CSf
Type of Form Form-5
Pack size & Demanded Price 1’s, 5’s:/ As per SRO
Approval status of product in Reference NEUPOGEN 30 MU (0,3 mg/mL), solution injectable of ANSM
Regulatory Authorities france approved (Available in prefilled syringes)
Me-too status GRASTIN INJECTION of M/s CCl (Reg # 052246)
IV
Remarks of the Evaluator Approval of section/manufacturing facility by the Central
report for renewal of DML verifying the section/manufacturing
facility.
Decision: Registration board referred the case to Biological Division since applied formulation is of
rDNA origin.
Brand Name +Dosage Form + Strength Arbex 150mg Tablet
Irbesartan…….150mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form 5
Approval status of product in Reference Aprovel 150 mg film-coated tablets of (MHRA approved)
Me-too status Irbest Tablets 150mg of M/s. Highnoon
Laboratories,
Brand Name +Dosage Form + Strength Arbex 300mg Tablet
Irbesartan…….300mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form 5
Approval status of product in Reference Aprovel 300 mg film-coated tablets of (MHRA
Regulatory Authorities approved)
Me-too status Irbest Tablets 300mg of M/s. Highnoon Laboratories,

Brand Name +Dosage Form + Strength Arbex D 300/12.5 mg Tablet
Composition Each Film Caoted Tablet Contains:
Irbesartan…300mg
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form 5
Approval status of product in Reference AVALIDE of ( USFDA approved)
Me-too status Irbest Plus Tablets of M/s Highnoon Laboratories
Brand Name +Dosage Form + Strength Irofit Tablet 20mg/2.5mg
Iron protein succinylate 400mg eq to elemental iron …20mg
Folic Acid……..2.5mg
Pharmacological Group Antianemic preparations
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s , :As per SRO
Me-too status Eisen Tablets of Genome Pharmaceuticals
Remarks of the Evaluator IV Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were declared/ approved
by the Registration Board in its 275th meeting
Brand Name +Dosage Form + Strength Ornex 3g Sachet
Composition Each Sachet Contains:
L-Ornithine-L-Aspartate…3gm
Pharmacological Group Hepatoprotectant
Type of Form Form 5
Approval status of product in Reference Hepa-Merz Sachet containing ornithine aspartate
Regulatory Authorities (granules for solution). AGES approved
Me-too status Couthy 3gm Sachet of M/s Martin Dow
Remarks of the Evaluator IV Refrence product contains granules while applied product
contain powder. Now firm change form 5 and formulation with
granules.
Brand Name +Dosage Form + Strength Fenak 500mg Tablet
Mefenamic Acid…500mg
Type of Form Form 5
Approval status of product in Reference Ponstan Forte Tablets 500mg of MHRA approved
Me-too status Genston 500mg Tablets of M/s Genome Pharmaceuticals
Remarks of the Evaluator IV  The firm change formulation from uncoated to film
coated with submission of fee of RS: 5000/- Deposit slip
no # 2017949, Dated: 03-08-2020
Brand Name +Dosage Form + Strength Methane 1% w/v Lotion
Permethrin…10mg
Pharmacological Group Pyrethroid insecticide
Type of Form Form 5
Pack size & Demanded Price 30ml: As per SRO
Approval status of product in Reference Nix lotion of USFDA approved
 Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm.
Brand Name +Dosage Form + Strength Proman 10mg/ml Injection
Protamine sulphate…10mg
Pharmacological Group Antidote to heparin
Type of Form Form 5
Approval status of product in Reference Protamine Sulfate 10mg/ml Solution for Injection
Regulatory Authorities of MHRA approved
Me-too status Protamine Sulphate Injection of M/s Isman Drugs House
Lahore. (Reg.# 008853)
Remarks of the Evaluator IV Source: Biological
Brand Name +Dosage Form + Strength Rancol xr 1000mg
Composition Each film coated extended release tablet contains:
Ranolazine…1000mg
Pharmacological Group Anti-Anginal
Type of Form Form 5
Pack size & Demanded Price 14’s :As per SRO
Approval status of product in Reference RANEXA of USFDA Approved
Me-too status Ranoline SR 1000mg Tablet (Reg# 078790) by
Searle IV Solutions
GMP status Last GMP inspection conducted on 19 -09-2018 aAnd report
“ Overall evaluation of the Inspection report is rated s Good
Brand Name +Dosage Form + Strength Rivarox 15mg Tablet
Rivaroxaban…15mg
Pharmacological Group Anticoagulant
Type of Form Form 5
Finished product Specifications Manufacturer,s specification
Pack size & Demanded Price 14’s, : As per SRO
Approval status of product in Reference Xarelto 15mg tablet Of ( USFDA Approved)
Me-too status Xarelto 15mg Tablet Of M/S Bayer
IV

Brand Name +Dosage Form + Strength Rovi 5mg Tablet
Rosuvastatin as Calcium Salt…5mg
Pharmacological Group HMG CoA reductase inhibitor/Antihyprlipidemic
Type of Form Form 5
Approval status of product in Reference CRESTOR tablet of (USFDA approved)
Me-too status RosuBar 5mg Tablet by M/s Barrett Hodgson
IV
Brand Name +Dosage Form + Strength Silrex 1% Cream
Sulpher Sulphadiazine…10mg
Pharmacological Group Antibiotic for topical use
Type of Form Form 5
Pack size & Demanded Price 10gm, 15gm, 20gm, 25gm, 30gm,50gm, 250gm, 500gm,: As per
SRO
Approval status of product in Reference Silvadene Cream of (USFDA approved)
Me-too status Quench cream of M/s Ferozesons
IV
Brand Name +Dosage Form + Strength Aricure 30mg/3ml Injection
Atracurium Besylate…30mg
Pharmacological Group Non-depolarizing skeletal muscle relaxant
Type of Form Form-5
recommended the grant of cGMP certificate to the firm
 Firm provided Atracurium 10mg/ml Solution for Injection
or Infusion of MHRA approved. But 3ml volume not
available in MHRA
Brand Name +Dosage Form + Strength Bamral 5mg/5ml Syrup
Pharmacological Group Selective beta-2-adrenoreceptor agonists
Type of Form Form 5
Me-too status Btno 5mg/5ml syrup by M/s Genix (Reg# 057873)
 Firm provided Bambuterol juice 1mg/ml by
AstraZaneca (Germany) but in Germany only 1mg
mentioned ml not mentioned
Brand Name +Dosage Form + Strength Dobicard 250mg/5ml IV Injection
Dobutamine Hcl…250mg
Pharmacological Group General anesthetic
Type of Form Form-5
Finished product Specifications USP Specs.
Me-too status Botamin Injection by M/s Fynk Pharmaceuticals
Remarks of the Evaluator IV Firm submitted fee of Rs: 5000/- Deposit slip No#
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)
Brand Name +Dosage Form + Strength Levon 1.5mg Tablet
Levonorgestrel…1.5mg
Pharmacological Group Hormonal contraceptives for systemic use
Pack size & Demanded Price 1 x 10’s , 1 x 20’s, 1 x 30’s:as per SRO
Approval status of product in Reference Ezinelle 1.5 mg tablet of MHRA approved
Me-too status Emkit-DS tablet 1.5mg of Zafa Pharma Reg # 032543.
Remarks of the Evaluator IV  The firm change formulation from film coated to un coated
with submission of fee of Rs: 5000/- Deposit slip No #
1984286, Dated : 07-08-2020.
 Approval of section/manufacturing facility (Steriodal
hormonal tablet) by the Central Licensing Board. However,
you may submit panel inspection report for renewal of DML
verifying the section/manufacturing facility.
Brand Name +Dosage Form + Strength Mebofac MR 200mg Capsule
Enteric Coated Pellets Mebeverie Hcl 50% Eq. to Mebeverie
Hcl…200mg
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
Me-too status Mebever MR capsule of M/s Getz Pakistan (050747)
IV
Remarks of the Evaluator Source of pellets : Vision pharmaceuticals
Brand Name +Dosage Form + Strength Averon 4mg Tablet
Ondansetron Hcl Dihydrate Eq. to
Ondansetron…….4mg
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 Reference ZOFRAN Of (USFDA Approved)
Me-too status Ondonix 4mg Tablet M/s Genix Pharma
Remarks of the Evaluator IV  The firm change formulation from uncoated to film
coated with submission of feeof Rs: 5000/- Deposit slip
No # 1984285, Dated : 07-08-2020
Applicant 44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan
Brand Name +Dosage Form + Strength Ilazole 10mg Tablet
Composition Each Enteric Coated Tablet Contains:
Ilaprazole……10mg
Pack size & Demanded Price 30’s, 60’s:As per SRO
compliance.
Brand Name +Dosage Form + Strength Ilazole 20mg Tablet
Ilaprazole……20mg
Pack size & Demanded Price 30’s, 60’s:As per SRO
compliance.
Brand Name +Dosage Form + Strength Ranol ER 375mg Tablet
Composition Each film coated Extended Release Tablet Contains:
Ranolazine…375mg
Pack size & Demanded Price 10’s, 20’s, 30’s, 60’s, 100’s :As per SRO
Approval status of product in ReferenceRanexa 375 mg prolonged-release tablets
Regulatory Authorities of TGA (Australia) Approved
compliance.
IV
Brand Name +Dosage Form + Strength Ranol ER 750mg Tablet
Ranolazine…750mg
Approval status of product in Reference Ranexa 750 mg prolonged-release tablets
Regulatory Authorities of TGA (Australia) Approved

compliance.
guidelines provided in 293rd meeting of Registration Board.
305. Duplication at serial no. 304.
Brand Name +Dosage Form + Strength Lorgy d 5mg Tablet
Desloratadine…….5mg
Pharmacological Group Anti-histamine
Type of Form Form 5
Approval status of product in Reference CLARINEX of USFDA approved
Me-too status Larinex Tablets of M/s Getz Pharma
Decision: Approved.
Brand Name +Dosage Form + Strength Lorgy-D 0.5mg/ml Syrup
Desloratadine…0.5mg
Pharmacological Group Antiallergic
Type of Form Form 5
Pack size & Demanded Price 60 ml : As per SRO
Approval status of product in Reference Clarinex of (USFDA approved)
Me-too status Desora Syrup by M/s S.J &G. Fazul Ellahie
308. 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 + Strength Accel 100mg Tablet
Aceclofenac…100mg
Type of Form Form 5
Approval status of product in Reference Aceclofenac of (MHRA approved)
Me-too status Acfonac 100mg Tablets M/s Medicraft
GMP status Inspection conducted on 18-10-2018 and GMP compliance level
is rated as GOOD.”

Brand Name +Dosage Form + Strength Bambu 10mg Tablet
Type of Form Form 5
Me-too status Bambu 10mg Tablets of M/s Alliance Pharmaceuticals
Brand Name +Dosage Form + Strength Bambu 20mg Tablet
Type of Form Form 5
Me-too status Bambu 20mg Tablets of M/s Alliance Pharmaceuticals
Brand Name +Dosage Form + Strength Esone 50mg Tablet
Eperisone HCl …50mg
Type of Form Form 5
Approval status of product in Reference Expose 50mg Tablet of AIFA Italy approved
Regulatory Authoritiesf
Me-too status Berelax 50mg Tablet by Ray Pharma Karachi Reg#061084
IV
Remarks of the Evaluator Firm change formulation from un coated tablet to film coated
1996273 Dated : 10-08-2020

Brand Name +Dosage Form + Strength Febsta 40mg Tablet
Febuxostat…40mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase
Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 5’s, 10’s, 20’s:As per SRO
IV
Remarks of the Evaluator Firm change formulation from un coated tablet to film coated
1996274 Dated : 10-08-2020
Brand Name +Dosage Form + Strength Febsta 80mg Tablet
Febuxostat…80mg
Pharmacological Group Antigout preparation(Non-purine xanthine oxidase
Inhibitor)
Type of Form Form 5
Remarks of the Evaluator IV Firm change formulation from un coated tablet to film coated
1996275 Dated : 10-08-2020
Brand Name +Dosage Form + Strength Zulid 100mg Suspension
Linezolid…100mg
Type of Form Form-5
Finished product Specifications Manufacturer Specification
Pack size & Demanded Price 30ml, 60 ml, 120ml & As per SRO
Approval status of product in Reference Zyvox 100 mg/5ml Granules For Oral Suspension By M/S
Regulatory Authorities Pharmacia Limited, (USFDA)
Me-too status Linzol 100mg /5ml oral dry suspension of M/s Regal Pharma
Brand Name +Dosage Form + Strength Locam 8mg Tablet
Lornoxicam…8mg
Type of Form Form 5
Brand Name +Dosage Form + Strength Sopro 200mcg Tablet
Misoprostol as 1 % HPMC…200mcg
Pharmacological Group Prostaglandin
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s,30’s, ; As per SRO
Approval status of product in Reference Cytotec of ( FDA approved)
Me-too status Miso 200mcg tablet M/s Global Pharmaceuticals,
IV
Brand Name +Dosage Form + Strength Nalphine 10mg Injection
Nalbuphine as Hcl…10mg
Pharmacological Group Opioid Analgesic
Type of Form Form 5
Pack size & Demanded Price 1ml; As per SRO
Approval status of product in Reference Nubain Injection 10mg/ml of Health Canada approved
Me-too status Nalfy Injection 10mg by M/s. Vision Pharmaceuticals,
Remarks of the Evaluator IV Terminal sterilization not performed.
Decision:Deferred for justification/clarification on scientific grounds of not performing Terminal
sterilization.
Brand Name +Dosage Form + Strength Nalphine 20mg Injection
Nalbuphine as Hcl…20mg
th
Type of Form Form 5
Finished product Specifications Manufacturer
Approval status of product in Reference Nubain Injection 20mg/ml of Health Canada approved
Me-too status Nalfy Injection 20mg by M/s. Vision Pharmaceuticals,
Decision:Deferred for justification/clarification on scientific grounds of not performing Terminal
sterilization.
Brand Name +Dosage Form + Strength Ptonix 40mg Tablet
Composition Each gastro resistant tabket contains:
Pantoprazole as sodium sesquihydrate…40mg
Type of Form Form 5
Pack size & Demanded Price 7’s, 14’s,28’s, , ; As per DRAP policy
Approval status of product in Reference Pantoprazole 40 mg Tablet Of ( MHRA Approved)
IV
Decision: Approved.
Brand Name +Dosage Form + Strength Rocyl 5mg Tablet
Procyclidine Hcl…5mg
Pharmacological Group Anti-Parkinson Drugs
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s,30’s, , ; As per DRAP policy
Approval status of product in Reference Kemadrin of USFDA approved
Me-too status Proclidine Tablets of M/ Shaheen Pharmaceuticals,
Decision: Approved.
Brand Name +Dosage Form + Strength Colchi 4mg Injection
Type of Form Form-5

Pack size & Demanded Price 2ml x 6’s / As per SRO
Approval status of product in Reference Coltramyl Injection by M/s Sanofi Aventis
Regulatory Authorities ANSM France
Me-too status Myovi 4mg/2ml Injection by Macter International (058692)
GMP status Inspection conducted on 18-10-2018 and GMP
compliance level is rated as GOOD.”
Decision: Deferred for justification/clarification on scientific grounds of not performing Terminal
sterilization.
Brand Name +Dosage Form + Strength Tdol Plus Tablets 37.5mg/325mg
Tramadol Hcl…37.5mg
Paracetamol…325mg
Type of Form Form-5
Approval status of product in Reference Tramacet tablet of (MHRA approved)
Me-too status Radol-P tablet of M/s Regal Pharmaceuticals
IV
Decision: Approved.
323. Name and address of manufacturer / M/s Medimarker's Labortaries Pvt Ltd
Applicant A-104, S.I.T.E Area, Hyderabad
Brand Name +Dosage Form + Strength Cefmark 250mg/Vial I.M Dry Powd
Pharmacological Group Cephalosporin
Type of Form Form 5
Approval status of product in Reference Rocephin I.M injection of (MHRA approved)
Me-too status Accucef 250 mg IM Injection M/s Wel Wink Pharmaceuticals,
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
Brand Name +Dosage Form + Strength Cefmark 500mg/Vial I.M Dry Powd
Type of Form Form 5
Me-too status Wixone 500 mg Injection IM M/s Wise Pharmaceuticals,
renewal DML
Brand Name +Dosage Form + Strength Cefmark 1gm/Vial I.M Dry Powd
Ceftriaxone as Sodium…1gm
Type of Form Form 5
Me-too status Accucef 1gm IM Injection M/s Wel Wink Pharmaceuticals,
renewal DML
Brand Name +Dosage Form + Strength Medifik 2% Cream
Fusidic Acid…20mg
Pharmacological Group Anti-bacterial
Type of Form Form-5
Pack size & Demanded Price 5gm, 15gm /As per SRO
Approval status of product in Reference Fucidin of MHRA Approved
Me-too status Ucid 2% Cream by Ciba Pharma (Reg. No. 081566)
renewal DML
 Availability of Cream sections could not be confirmed.
Brand Name +Dosage Form + Strength Megenta Drops 0.3%
Gentamycin as sulphate…0.3% w/v
Pharmacological Group Aminoglycoside Antibiotic
Type of Form Form-5
Pack size & Demanded Price 5ml, 7.5ml & 10ml; /As per SRO
Approval status of product in Reference Genoptic of USFDA approved
Me-too status Ocugent 0.3% 5ml & 10ml Drops of M/s Farmigea Pharma

renewal DML.
Remarks of the Evaluator IV Eye and Ear drop section available
328. Name and address of manufacturer / M/s Baxter Pharmaceuticals.
Applicant A-1/A, Scheem No.33,Phase-1,S.I.T.E,Super Highway, Karachi
Brand Name +Dosage Form + Strength Bex para 1000mg/100ml Injection
Paracetamol…1000mg
Pharmacological Group Analgesic & Antipyretic
Type of Form Form 5
Finished product Specifications Manufacturer's specification
Pack size & Demanded Price 100ml ;As per SRO
Approval status of product in Reference Acetaminophen of (USFDA approved)
Me-too status Bofalgan 1g/100ml Infusion M/s Bosch Pharmaceuticals
GMP status Last GMP inspection conducted on 20-09-2019, and the
report concludes that the current compliance level of firm is
rated as satisfactory.
&
Last inspection of Safe pharmaceuticals conducted on 04-03-
2019 and report concludes that “All the observations pointed out
during inspection were discussed with the management of the
firm and they were committed to overcome before next periodic
inspection. Based on the above observations and keeping in view
their attitude for better compliance, their current compliance
level is rated as Good.”
Remarks of the Evaluator Number of sections of applicant approved by Licensing Board:
08
Number of products already registered/approved on contract
manufacturing in the name of applicant: Nil
Decision: Registration Board referred the case back to the panel to access overall capacity of the
analytical equipments of firm including HPLC keeping in view pharmacopeial and other
requirements of all registered drug products.
Brand Name +Dosage Form + Strength Baxmeco 500mcg Injection
Mecobalamin…500mcg
Pharmacological Group Co-enzyme-type vitamin B12
Type of Form Form 5
Approval status of product in Reference PMDA approved
Me-too status Wycomin 500 mcg Injection by Wnsfeild Pharmaceutical,
&

08
Brand Name +Dosage Form + Strength Bex D3 Injection
Cholecalciferol…5mg
Pharmacological Group Vitamin D analogue
Type of Form Form 5
Approval status of product in Reference Vitamin D3 Good 200,000 IU / 1 ml IM solution for
Regulatory Authorities injection of ( ANSM France approved)
Me-too status Calciferol Injection M/s Global Pharmaceuticals,
&
08
Brand Name +Dosage Form + Strength Bexsucrose 100mg/5ml Injection
Iron Sucrose…100mg
Pharmacological Group Iron replacement product
Type of Form Form 5

Approval status of product in Reference Venofer 100mg/5ml Injection of MHRA approved
Me-too status Bisleri 100mg/5ml Injection of M/S Sami Pharma
&
08
Brand Name +Dosage Form + Strength Bexdrota 40mg/2ml
Drotaverine HCL…40mg Drotaverine
Type of Form Form-5
Approval status of product in Reference Three European countries Bulgaria, Romania, Hungary
&
08

Brand Name +Dosage Form + Strength Bexome 40mg Injection
Composition Each vial of dry substance contains:
Omeprazole Sodium eq to Omeprazole Sodium…40mg
Type of Form Form 5
Approval status of product in Reference Omeprazol 40mg injection of (MHRA approved)
Me-too status Fymezole Dry Powder Injection IV of M/s Fynk Pharma
&
08
Brand Name +Dosage Form + Strength Baxeso 40mg Injection
Esomeprazole Sodium eq to Esomeprazole Sodium…40mg
Type of Form Form 5
Approval status of product in Reference Nexium IV injection of (USFDA approved)
Me-too status Esold Injection of M/s Weather Folds Pharmaceutical
&

08
Brand Name +Dosage Form + Strength Bexsunate 30mg Injection
Artesunate…30mg
Pharmacological Group Antimalarial
Finished product Specifications IP
WHO recommended formulation
Me-too status Gen-M Injection of M/s Genix Pharma
&
08
Artesunate…60mg
Me-too status Misonate 60mg Injection by M/s Tabros Pharma (Reg#057719)

&
08
Artesunate…120mg
Me-too status Gen-M Injection of M/s Genix Pharma
&
08
Brand Name +Dosage Form + Strength Baxarit 80mg/ml Injection

Artemether…80mg
Type of Form Form 5
Approval status of product in Reference WHO approved formulation
Me-too status Artesinate Injection of M/S Gray's Pharmaceuticals
&
08
339. Name and address of manufacturer / M/s Baxter Pharmaceuticals., A-1/A, Scheem No.33, Phase-
Applicant 1,S.I.T.E,Super Highway, Karachi
Contract manufactured By: M/s Safe Pharmaceuticals Pvt Ltd.,
Brand Name +Dosage Form + Strength Baxtidine 50mg/ml Injecion
Ranitidine as Hydrochloride…50mg
Pharmacological Group Antihistamine (H2 receptor antagonist)
Type of Form Form 5
Approval status of product in Reference ZANTAC Injection of USFDA approved
Me-too status Peptinil 50mg Injection of M/S Wilson’s Pharmaceuticals,
&
08

Decision: Registration Board in its 294th meeting has decided to suspend registration of all ranitidine
containing medicinal products, based upon the FDA decision.
Brand Name +Dosage Form + Strength Volden-M 50mg/200mcg Tablet
Composition Each Delayed Release Tablet Contains:
Diclofenac Sodium…50mg
Misoprostol…200mcg
Pharmacological Group NSAID along with mucoprotective
Type of Form Form-5
Pack size & Demanded Price 20’s / As per SRO
Approval status of product in Reference Arthrotec of USFDA Approved
Me-too status Dipros 50 Tablet by Helix (Reg. No#076456)
Remarks of the Evaluator  The formulation contains misoprostol 1% HPMC dispersion &
product is approved in USFDA as delayed release tablet that
consists of a gastro resistant core containing 50mg of
diclofenac sodium surrounded by an outer mantle containing
200mcg misoprostol along with box warning.
 Firm revise formulation from plain tablet to bilayer delayed
release tablet in line with reference product With submission
of fee of Rs: 5000/- Deposit slip no # 2017947, dated: 03-8-
2020
 For Evidence of bilayer machine firm submitted invoice from
Shanghai Tianhe pharmaceuticals china
Brand Name +Dosage Form + Strength Volden-M 75mg/200mcg Tablet
Pharmacological Group NSAID along with mucoprotective
Type of Form Form-5
Approval status of product in Reference Arthrotec of USFDA Approved
Me-too status Dipros 75 Tablet by Helix (Reg. No#076456)
above 16,new/additional sections
Remarks of the Evaluator  The formulation contains misoprostol 1% HPMC dispersion
and product is approved in USFDA as delayed release tablet
that consists of a gastro resistant core containing 50mg of
diclofenac sodium surrounded by an outer mantle containing
200mcg misoprostol along with box warning.
 Firm revise formulation from plain tablet to bilayer delayed
release tablet in line with reference product With submission
of fee of Rs: 5000/- Deposit slip no # 2017948, dated: 03-
08-2020
 For Evidence of bilayer machine firm submitted invoice
from Shanghai Tianhe pharmaceuticals china
342. Name and address of manufacturer / M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
Brand Name +Dosage Form + Strength Seipil ER 330mg Tablet
Pregabalin…330mg
Pharmacological Group Anti-epileptic
Approval status of product in Reference LYRICA CR of USFDA approved
GMP status Last inspection was conducted on 10-04-2019 and
report concludes that firm is operating at an
acceptable level of cGMP compliance.
Decision: Deferred for consideration on its turn alongwith stability data as per requirement
determined by Registration Board in 293rd meeting.
b. Deferred cases
343. Name and address of manufacturer / Paramount Pharmaceuticals, 36-Industrial Triangle,
Manufactured by:
Bio Labs (Pvt) Ltd, Plot #, Industrial Triangle, Kahuta
Road Islamabad
Brand Name +Dosage Form + EPI 40mg Injection
Strength
Composition Each vial contain:
Esomeprazole (as Sodium)........40mg
Diary No. Date of R& I & fee Dy. No. 5781 Date:29-08-2016 Rs. 50,000/-
Pharmacological Group Proton pump inhibitors
Type of Form Form 5
Finished product Specifications Manufacturer spec
Pack size & Demanded Price 1’s : As per PRC
Approval status of product in Nexium I.V. 40mg of (MHRA approved)
Reference Regulatory Authorities
Me-too status (with strength and Esold Injection of M/s Weather Folds Pharmaceutical
dosage form)
GMP status Last inspection of Bio-Labs conducted on 05-12-2017 &
06-12-2017 and report concludes that firm is found at fair
level of GMP compliance
Previous remarks of the Evaluator. Contract agreement attached
Number of already registred contract manufactured
products: Nil
Previous decision(s) Deferred for following reasons:
Registration Board deferred the case for assessment and
confirmation of manufacturing capacity of M/s Biolabs by
panel to be constituted by Chairman Registration Board
for further granting contract manufacturing permission as

the firm has already been granted approval for contract
manufacturing of numerous products (M-282)
Evaluation by PECIV Registration Board discussed the inspection report in
details. Deliberations were made on used and available
capacity keeping in view registered product, currently
applied products and future products. After thorough
deliberation, the Board decided to allow contract
manufacturing from M/s Bio-Labs (Pvt) Ltd. Plot No.145
Industrial Triangle, Kahuta Road, Islamabad for
following sections:
 Dry Suspension (Cephalosporin)
 Capsule (Cephalosporin)
 Dry vial injectable (Cephalosporin)
 Llyophilized vial injectable (General)
Registration Board deferred the case for confirmation of
dry powder vial filling facility.(M-295)
Evaluation by PECIV Firm replied that Lyophilization is being performed at
Bio-Labs(Pvt)
Decision: Deferred for confirmation of method of manufacturing (lyophilization or dry
powder filling) from initially submitted application/dossier.
344. Name and address of manufacturer / M/s Saydon Pharmaceutical Industries Pvt Ltd.
Applicant 77-A, Hayatabad Industrial Estate, Peshawar
Brand Name +Dosage Form + Sayfon 80/80 mg Tablet
Strength
Composition "Each Sugar Coated Tablet Contains:
Phloroglucinol DiHydrate …………………..80mg
Trimethyl phloroglucinol……………… ……80mg"
Diary No. Date of R& I & fee Dy. No 14477 dated 18-04-2018 Rs.20,000/- Dated 18-
04-2018
Pharmacological Group Gastrointestinal Anticholinergic
Type of Form Form 5
Finished product Specifications The firm has claimed Manufacturer specification.
Approval status of product in Approved in ANSM
Me-too status (with strength and Anafortan plus tablet of M/s AGP Ltd. Karachi. Reg. No.
dosage form) 24504
GMP status “Last GMP inspection conducted on 13-02-2018”
Previous remarks of the Evaluator.
Deferred for updated status of GMP of the firm form QA
& LT division as inspection report submitted by firm does
not conclude GMP compliant status. (M-289)
Evaluation by PEC 22-10-2018 and 22-11-2018 Conclusion:
Overall the firm was in good working condition and
following the GMP guidelines as per Drugs, Act, 1976
and rules framed there under. Based on the area inspected
the people met and document reviewed and considering
the findings of inspection of M/s Saydon Peshawar is
considered to be operated at acceptable level of
compliance with GMP guideline as per Drugs, Act, 1976
and rules framed there under.

Brand Name +Dosage Form + Sayfon 40/0.04 mg Injection
Strength
Composition "Each 4ml Ampoule Contains:
Phloroglucinol Hydrate………………40mg
Trimethyl phloroglucinol…………….0.04mg"
Diary No. Date of R& I & fee Dy. No 14476 dated 18-04-2018 Rs.20,000/- Dated 18-
04-2018
Pharmacological Group Gastrointestinal Anticholinergic
Type of Form Form 5
Finished product Specifications The firm has claimed Manufacturer specification.
Approval status of product in SPASFON, solution for injection in ampoule by M/s
Reference Regulatory Authorities TEVA HEALTH, (ANSM Approved)
Me-too status (with strength and Spasfon Injection 4ml by M/s Himont (Reg. # 018530)
dosage form)
Deferred for updated status of GMP of the firm form QA
& LT division as inspection report submitted by firm does
not conclude GMP compliant status. (M-289)
following the GMP guidelines as per Drugs, Act, 1976
and rules framed there under. Based on the area inspected
the people met and document reviewed and considering
the findings of inspection of M/s Saydon Peshawar is
considered to be operated at acceptable level of
compliance with GMP guideline as per Drugs, Act, 1976
346. Name and address of manufacturer / M/s Don Valley Pharmaceuticals.
Applicant 31-km, Main Ferozepur Road, Lahore
Brand Name +Dosage Form + Coagbon 10mg Tablet
Strength
Rivaroxaban…..…10mg
Diary No. Date of R& I & fee Dy.No. 17066 dated 08-05-2018 Rs.20,000/- Dated 08-
05-2018
Pharmacological Group Anticoagulant
Type of Form Form 5
Finished product Specifications Manufacturer,s specification
Pack size & Demanded Price 10’s, 14’s 20’s & 30’s ; As per SRO
Approval status of product in Xarelto 10mg tablet Of ( USFDA Approved)
Me-too status (with strength and Xarelto 10mg Tablet Of M/S Bayer
dosage form)
GMP status Last GMP inspection conducted on 19-05-2017.
And report concludes that overall firm has fair GMP
compliance
Previous remarks of the Evaluator. Covering letter and challan form of different product
submitted.
Previous decision(s) Deferred for submission of fee.(M-295)
Evaluation by PEC  Firm replies that they have already submitted the
20,000 for Registration purpose .
Covering letter and challan form Coagbon 10mg
Tablet was attached in another product dossier.
347. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd., 19 Km,
Applicant Sheikhupura Road, Faislabad
Contract manufactured By
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km,
Ferozepur Road, Lahore
Brand Name +Dosage Form + Gloricef 250mg IV/IM Injection
Strength Cefxil
NeoClaf
Cefotaxime Sodium eq. to Cefotaxime……250mg
10-2018
Pack size & Demanded Price 1’s :As per SRO
Approval status of product in Cefotaxime powder for solution for injection of MHRA
Reference Regulatory Authorities approved
Me-too status (with strength and Exoran of M/s City Pharma
dosage form)
GMP status Last GMP inspection conducted on 08-10-2019 and
report concludes that firm was considered to be opeating
at Good level of compliance
&
Last GMP inspection conducted on 22-01-2019 and
report concludes firm is considered to be operating at
Good level of compliance of GMP requirements
Previous remarks of the Evaluator.  Number of products already registered/approved
on contract manufacturing in the name of
applicant: Nil
Previous decision(s) Registration Board deferred the case for assessment and
confirmation of manufacturing capacity of M/s Novamed
Pharmaceuticals by panel to be constituted by Chairman
Registration Board for further granting contract
manufacturing permission as the firm has already been
granted approval for contract manufacturing of numerous
products..(M-293)
Evaluation by PEC Firm submitted report on assessment and confirmation of
manufacturing capacity for contract manufacturing and
board after thorough deliberation decided to allow
contract manufacturing from M/s Novamed
Pharmaceuticals for Dry Powder Injection (cephalosporin)
section
Decision: Approved.
348. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd., 19 Km
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km,
Brand Name +Dosage Form + Gloricef 500mg IV/IM Injection
Strength Cefxil
NeoClaf

Cefotaxime Sodium eq. to Cefotaxime……500mg
10-2018
dosage form)
&
applicant: Nil
products..(M-293)
board after thorough deliberation decided to allow contract
manufacturing from M/s Novamed Pharmaceuticals for
Dry Powder Injection (cephalosporin) section.
M/s Saffron pharma has 5 products already registered on
contract manufacturing.
Decision: Approved.
349. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd., 19 Km
M/s Novamed Pharmaceuticals (Pvt) Ltd., 28-km,
Brand Name +Dosage Form + Gloricef 1g IV/IM Injection
Strength Cefxil
NeoClaf
Cefotaxime Sodium eq. to Cefotaxime……1g
10-2018

dosage form)
&
applicant: Nil
products..(M-293)
board after thorough deliberation decided to allow contract
manufacturing from M/s Novamed Pharmaceuticals for
Dry Powder Injection (cephalosporin) section.
M/s Saffron pharma has 5 products already registered on
Decision: Approved.
350. Name and address of manufacturer / M/s Oval Pharmaceuticals,112/11, Quaid-e-Azam
Applicant Industrial Estate, kot Lakhpat, Lahore
Brand Name +Dosage Form + Reodene Solution 100mg/ml (Povidone-Iodine)
Strength
Povidone-Iodine…100mg(10%)
Diary No. Date of R& I & fee Dy.No 4768 dated 09-02-2018 Rs. 20,000/- Dated 09-02-
2018
Pharmacological Group Antiseptic, germicidal
Type of Form Form 5
Pack size & Demanded Price 60ml,450ml; Rs : 77/60ml & 377/450ml
Approval status of product in BETADINE ANTISEPTIC TOPICAL SOLUTION
Reference Regulatory Authorities povidone-iodine 100mg/mL solution
Me-too status (with strength and PYODINE 10% solution by Brookes Pharma.
dosage form)
GMP status Last GMP inspection conducted on 07-01-2020., and
the report concludes that “ In view of above findings of
inspection, areas checked, documents, documents
reviewed,the panel of the opinion that firm had rectified
most of the previous observation. Hence the firm allowed to
resume the production activities. The management assured
that they would follow the Drug act 1976 for GMP
compliance
Previous remarks of the Evaluator. Firm applied for regularization of layout in which external
preparation section is also mentioned.(Section still not
approved)
Previous decision(s) Deferred for confirmation of required manufacturing
facility / section from Licensing Division...(M-295)

Evaluation by PEC Firm submitted approval of regularization and new
sections layout plan from DRAP in which External liquid
preparations section mentioned
Decision: Deferred for confirmation of required manufacturing facility / section.
Case no. 02 Registration applications for local manufacturing of (veterinary) drugs

a. New Cases
351. Name and address of manufacturer / MYLAB Pvt. Ltd, Khankah Shariff
Applicant Bahawalpur.
Brand Name +Dosage Form + Amectin Injection
Strength
Abamectin…….10mg
Dated 04-12-2018
Pharmacological Group Anthelmintic
Type of Form Form 5
Finished product Specification Manufacturer‘s specifications
Pack size & Demanded Price 50ml: Decontrolled
Reg.No. 031453
Me-too status
Abatek Injection 10mg M/S Star Labs,
GMP status Panel inspection conducted on 13-09-2018 to
14-09-2018 recommends renewal of DML and
grant of additional sections.
Brand Name +Dosage Form + Selferol Injection
Strength
Vitamin E…75mg
Sodium Selenite…0.6mg
Dated 04-12-2018
Pharmacological Group Vitamin and selenium Supplement
Type of Form Form 5
Pack size & Demanded Price 50ml., Decontrolled
Reg.No.034579
Me-too status Selferol Injection Of M/S Selmore
Pharmaceuticals
Remarks of the Evaluator IV Alternate brand name:
 Selmeg
Brand Name +Dosage Form + Streplin Injection
Strength
Procaine Penicillin G…200mg
Dihydrostreptomycin Sulphate Eq. to
Dihydrostreptomycin…200mg

Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 50ml :Decontrolled
Reg.No.083244
Me-too status
Streplin Inj of M/S Selmore Pharmaceuticals
 Megapen
Decision: Deferred for confirmation of required manufacturing facility “Liquid
injectable Penicillin section” from licensing division.
Brand Name +Dosage Form + Tonovit Injection
Strength
Toldimfos Sodium…200mg
Vitamin B12…0.05mg
Dated 04-12-2018
Pharmacological Group Vitamins
Type of Form Form 5
Pack size & Demanded Price 10ml,Decontrolled
Reg.No.033253
Me-too status Tonovit Injetion Of M/S Selmore
harmaceuticals
IV
Remarks of the Evaluator Alternate brand name:
 Mytovit
Brand Name +Dosage Form + Selphos Injection
Strength
Sodium Selenite…0.5mg
Vitamin E…70mg
Vitamin B12…0.1mg
Vitamin B1…20mg
Adenosine-5-Monophosphate…5mg
Dated 04-12-2018
Pharmacological Group Vitamin
Type of Form Form 5
Pack size & Demanded Price 10ml,Decontrolled
Reg.No 029647
Me-too status Selphos Injection Of M/S Selmore
Pharmaceuticals

 Myphos
Brand Name +Dosage Form + Dr.Mectin Injection
Strength
Ivermectin…2mg
Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price Decontrolled
Remarks of the Evaluator IV Ivovectin Injection of M/s Vetz Pharmaceuticals
(50ml)Reg# 079289
Each ml conatins
Ivermectin…20mg
Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status)
alongwith registration number, brand name and
name of firm.
Decision: Deferred for evidence of applied formulation/drug already approved by
DRAP (generic status) alongwith registration number, brand name and name of
firm.
Brand Name +Dosage Form + Icozol Injection
Strength
Ricobendazole…10gm
Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 100ml:Decontrolled
Reg.No.033252
Me-too status Ricozole Injection M/S Selmore
Pharmaceuticals

Brand Name +Dosage Form + Levamicclosan Injection
Strength
Closantel sodium dihydrate…5gm
Levamisole Hcl…10gm
Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 50ml, Decontrolled
Reg.No.062075
Me-too status Levamiclosan Injection of M/S International
Pharma Labs.,
 Levasel
Brand Name +Dosage Form + Fospho-AV Injection
Strength
Butaphosphan…100mg
Taurine…37.3mg
Nicotinamide…23mg
DDL-Methionine…18.7mg
Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 50ml, Decontrolled
RegNo.058816
Me-too status
Carasil Injection Of M/S Selmore Agencies
Brand Name +Dosage Form + Tygent Injection
Strength
Tylosin Tartrate…100mg
Gentamicin as Sulphate…50mg
Dated 04-12-2018
Type of Form Form 5
Me-too status Reg.No.049636
Tygent Injection Of M/S Selmore
Pharmaceuticals
IV
 Gentyl
Brand Name +Dosage Form + Phosvit Injection
Strength
Butaphosphan…100mg
Vitamin B12…0.05mg
Dated 04-12-2018
Type of Form Form 5
Reg.No.039969
Me-too status Catosal 10% Injectable Solution of M/s Bayer
Pakistan (Available in 100ml)
Brand Name +Dosage Form + Lidocain 2% Injection
Strength
Lignocaine Hcl…20mg
Dated 04-12-2018
Pharmacological Group Local Anaesthetic
Type of Form Form 5
Pack size & Demanded Price As per SRO : Decontrolled
Reg.No. 041229
Me-too status Lidocain 2% Injection Of M/S. International
Pharma,
 Mydocain
Brand Name +Dosage Form + Tylotrim Injection
Strength
Sulphamethoxypyridazine…150mg
Trimethoprim…30mg
Tylosin Tartrate…50mg
Dated 04-12-2018
Type of Form Form 5
Reg.No.046515
Me-too status Tylotrim Injection Of M/S Selmore
Pharmaceuticals,
IV
 Cotrim
Decision: Deferred for confirmation of Sulphamethoxypyridazine: Trimethoprim
for 1:4 or 1:5 as per RRA
Brand Name +Dosage Form + BPS-LA Injection
Strength
Procaine Penicillin G…125,000 IU
Benzathine Penicillin G…100,000 IU
Dihydrostreptomycin Sulphate Eq. to
Dihydrostreptomycin…200mg
Dated 04-12-2018
Pharmacological Group Penecilline antibiotic
Type of Form Form 5
Pack size & Demanded Price 50ml : Decontrolled
Reg.No 080951
Me-too status
BPS-LA of M/S Selmore Pharaceuticals
 Benzapen LA
Brand Name +Dosage Form + I-ZVS Oral Solution
Strength
Zinc…800mg
Vitamin E…150,000mg
Selenium…1670mg
Dated 04-12-2018
Pharmacological Group Vitamin & mineral
Type of Form Form 5
50ml, 100ml, 250ml, 500ml, 1liter, 5 liter:
Pack size & Demanded Price
Decontrolled
Remarks of the Evaluator IV Evidence of applied formulation/drug already
name of firm.

Evidence of applied formulation/drug already approved by DRAP (generic / me-
too status) alongwith registration number, brand name and name of firm.
For salt form of Zinc and Selenium
Brand Name +Dosage Form + I-Colifos-250 Oral Solution
Strength
Colistin Sulphate…250,000,00 IU
Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 250ml, 500ml, 1liter, 5 liter: Decontrolled
IV
Remarks of the Evaluator Reg.No.082810
I-Colifos-250 Oral Solutionof M/S International
Pharma Lahore(Colistin Sulphate…250,000,000
IU)
Alternate brand name:
 Mycostin oral solution
Evidence of applied formulation/drug lready
name of firm.
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.
Brand Name +Dosage Form + Clozadil Oral Suspension
Strength
Oxyclozanide…3.4%
Dated 04-12-2018
Type of Form Form 5
Pack size & Demanded Price 250ml,500ml,1 Liter, 5liter: Decontrolled
Reg.No.041226
Clozadil Suspension Of M/S International
Me-too status
Pharma
Lab’s.
 Oxynide Oral solution
368. Name and address of manufacturer / M/s ICI Pakistan Limited Life Sciences.
Applicant 45-KM, off Multan Road, Lahore
Brand Name +Dosage Form + Promectin D Drench
Strength
Ivermectin…10mg
Diary No. Date of R& I & fee Dy.No. 44139 dated 27-12-2018 Rs.20,000/-
Dated 26-12-2018
Pharmacological Group Anthlmentic
Type of Form Form 5
Pack size & Demanded Price 100 ml, 250ml, 500ml, 1000ml ; Decontrolled
Ivotek Drench 1%.Of M/S Star Laboratories
Me-too status
Reg.# 063601
GMP status Last GMP inspection report dated 25-01-2018
and report concludes that firm was GMP
compliant.
369. Name and address of manufacturer / M/s ICI Pakistan Limited Life Sciences.
Applicant 45-KM, off Multan Road, Lahore
Brand Name +Dosage Form + Nilzan Drench Super
Strength
Oxyclozanide…6gm
Levamisole HCL…3gm
Cobalt suplhate…0.764gm
Heptahydrate
Sodium selenate…0.076gm
Diary No. Date of R& I & fee Dy.No. 44140 dated 27-12-2018 Rs.20,000/-
Dated 26-12-2018
Pharmacological Group Anthlmentic
Type of Form Form 5
Pack size & Demanded Price 100 ml, 250ml, 500ml, 1000ml ; Decontrolled
Leox Ds Plus Oral Suspension Of M/S Elko
Me-too status Organizaiton
Reg.# 031595
GMP status Last GMP inspection report dated 25-01-2018
and report concludes that firm was GMP
compliant.
Case no. 03 Registration applications of categories to be considered on priority

a. Export facilitation
Deferred cases

Brand Name +Dosage Form + Cefsure 2gm IM Injection
Strength
Diary No. Date of R& I & fee Dy.No. 8527 dated 26-02-2019 Rs. 20,000 Dated 25-02-
2019
Type of Form Form 5
Approval status of product in Ceftriaxone 2g powder of MHRA approved
Me-too status (with strength and Triax 2gm Injection of M/s.Wilshire Laboratories
dosage form)
GMP status Certificate of GMP based on inspection conducted on
30-09-2019
Previous remarks of the Evaluator. In generic IM or IV can not be differentiated.
Previous decision(s) Deferred for evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) alongwith
.(M-295)
Evaluation by PEC Firm submitted that they have mistakenly written I.M
route instead of I.V now for change of formulation they
submitted fee of Rs: 5000/-, Deposit slip No# 1903533
Dated : 31-08-2020
Decision: Approved. Firm shall deposit remaining fee Rs.15000/- before issuance of
registration letter.

a. Deferred cases
i. Human
371. Name and address of Applicant M/S Bristol Mayer Biotech Pakistan, 73-B Guldasht
Town Lahore Cantt Pakistan
Detail of Drug Sale License Address : 73-B Guldasht Town, Zarar Shaheed road
Lahore
Validity : 07/04/2020
Status: to sell drugs in a whole sale distribution
Name and address of VEM ILAC San.ve Tic. A.s. Çerkezköy Organize Sanayi
manufacturer Bölgesi Karaağaç Mahallesi Faith Bulvari No: 38 Kapakli/
TEKIRDAĞ/TURKEY
Name and address of VEM ILAC San.ve Tic. A.s.
marketing authorization holder Söğütözü Mahallesi 2177. Cadde No: 10B/49
Cankaya/Ankara/Turkey
Name of exporting country Turkey
Diary No. & Date of R& I Dy No : 33319 Dated : 08/10/2018
Fee including differential fee Rs : 50,000 Dated : 08/10/2018
Brand Name +Dosage Form + Fericose 100mg/5ml I.V Solution for Injection
Strength
Composition Each 5ml ampoule Contains
Iron as Iron Sucrose (Iron (III) Hydroxide Sucrose Complex)
Eq to elemental Iron………100mg
Finished Product Specification USP
Pharmacological Group Iron Trivalent Parentral prepartions
Shelf life 36 months
Demanded Price As per SRO
Pack size 1 Vial/box
International availability Venofer 100mg/5ml Injection of MHRA approved
Me-too status Bisleri 100mg/5ml Injection of M/S Sami Pharma
Detail of certificates attached Valid and Legalized CoPP
Certificate No: 2018/3541
Certified by: Turkish Medicines and Medical devices
Agency Söğütözü Mahallesi 2176. Sokak No:5 06520
Product license and date of issue : 252/21 -23 July.2013
Valid until : 03-10-2020
Free sale: Free sale of the product in exporting country:
Yes confirms from COPP
GMP certificate
GMP certificate No : TR/GMP/2018/27
Date of Issue: 30-01-2018
Valid until : 05/2020
GMP certificate and Free sale certificate
Certificate No : 2018/3635
Valid until : 09-10/2020
Sole Contract Agreement
22-10-2018
Validity: 2 Years
Remarks of the Evaluator. 
Remaining fee of Rs:50000/- Submitted. Deposit slip
No# 1957531 Dated: 02-12-2019
 Stability studies according to Zone IV-A not submitted.
Previous Decision: Deferred for following (M-295)
Stability studies according to Zone IV-A not submitted.
Evaluation by PEC Firm submitted stability studies according to Zone IV-A, 6th
month accelerated and 36th month Real time studies
Decision: Approved with Innovator’s specifications as per Policy for inspection of
Manufacturer abroad.
372. Name and address of Applicant M/S Bristol Mayer Biotech Pakistan, 73-B Guldasht
Town Lahore Cantt Pakistan
Detail of Drug Sale License Address : 73-B Guldasht Town, Zarar Shaheed road
Lahore
Validity : 07/04/2020
Status: to sell drugs in a whole sale distribution
Name and address of VEM ILAC San.ve Tic. A.s. Çerkezköy Organize Sanayi
manufacturer Bölgesi Karaağaç Mahallesi Faith Bulvari No: 38 Kapakli/
TEKIRDAĞ/TURKEY
Name and address of marketing VEM ILAC San.ve Tic. A.s.
authorization holder Söğütözü Mahallesi 2177. Cadde No: 10B/49
Fee including differential fee Rs : 50,000 Dated : 21/05/2018 + Rs : 50000
:Dated: 16-10-2019

Brand Name +Dosage Form + Candisept 100mg/50ml I.V Solution for Infusion
Strength
Composition Each 50ml Vial Contains
Fluconazole ……100mg
Pharmacological Group Triazole antifungal derivatives
Pack size 1 Vial/box
International availability Fluconazole 2mg/ml solution for infusion of MHRA
approved
Me-too status Lumen 2mg/Ml Injection (50ml) Of M/S Nimrall
Farma (Reg # 039823)
Product license and date of issue : 254/16 _05.11.2013
Free sale: Free sale of the product in exporting
country:
GMP certificate:
07-06-2018
Validity: 2 Years
Remarks of the Evaluator. Deficiencies/Shortcomings Reply by Firm
Remaining fee of Remaining fee of Rs:50000/-

Rs:50000/- as product is Submitted. Deposit slip No#
already registered in 1914215 Dated: 16-10-2019
Pakistan.
Justify use of Type II glass According to the European
as primary packaging Pharmacopoeia “3.2.1 Glass
material while in reference Containers for
agency Type I glass is used Pharmaceuticals Use” Type II
as primary packaging glass containers are suitable
material. for most acidic and neutral
,aqueous prepartations
whether or not for parenteral
administration. Our product is
near neutral and aqueous
solution. Therefore, Type II
glass is suitable for this
product.

Previous Decision: Deferred for Clarification/Justification on scientific
gronuds for use of Type II glass container as primary
packaging material for applied formulation or
otherwise evidence of reference product packed in
Type II glass container (M-293)
Evaluation by PEC Firm submitted that since DRAP couldn’t be convinced
with explanations for use of Type II glass vials , Now
VEM ILAC TURKEY will now use the type I Glass
vials for Pakistan and submitted declaration from VEM
Ilac Sanayi ve Ticaeret A.s that they will export their
product to Pakistan with Type I glass vials.
Decision: Regtistration Board
a. New cases
373. Name and address of M/s. Martin Dow Limited, Plot No. 37, Sector 19, Koramngi
manufacturer / Applicant Industrial Area Karachi, Pakistan
Brand Name +Dosage Form + Dexdow Delayed Release 30mg Capsules
Strength
Composition Each Delayed Release Capsule contains:
dexlansoprazole pellets 22.5% eq to
Dexlansoprazole….………..60mg
Pharmacological Group Proton Pump inhibitor
Type of Form Form 5
Approval status of product in Dexilant Delayed Release Capsule 60mg of
Reference Regulator Authorities USFDA approved
GMP status The firm was operating at good level of compliance with
GMP as per inspection report dated 06/12/2018
Remarks of the Evaluator4
Drug Dexdow Delayed Release 30mg Capsules
Name of Manufacturer M/s. Martin Dopw Limited, Plot No. 37, Sector 19, Koramngi Industrial Area
Karachi, Pakistan
Manufacturer of API M/s Vision Pharmaceuticals
API Lot No. DLP376
Date of Submission 27-01-2020 (31664)
Firm initially submitted stability data of Dexdow Delayed Release 30mg Capsules with API source
from M/s Vision Pharmaceuticals, but later submitted request for withdrawal of submitted stability studies
and said that they are changing the proposed source of API pellets of the said product, so it is requested to
hold the evaluation till submission of revised stability studies.
Decision: Registeration Board acceded firm’s request and deferred for submission of stability data as
per requirement decided in 293rd meeting

374. Name and address of M/s. Martin Dopw Limited, Plot No. 37, Sector 19,
manufacturer / Applicant Koramngi Industrial Area Karachi, Pakistan
Brand Name +Dosage Form + Dexdow Delayed Release 30mg Capsules
Strength
Composition Each Delayed Release Capsule contains:
dexlansoprazole pellets 22.5% eq to
Dexlansoprazole….………..60mg
Pharmacological Group Proton Pump inhibitor
Type of Form Form 5
Approval status of product in Dexilant Delayed Release Capsule 60mg of
Reference Regulator Authorities USFDA approved
GMP status The firm was operating at good level of compliance with
GMP as per inspection report dated 06/12/2018
Remarks of the Evaluator4
Drug Dexdow Delayed Release 30mg Capsules
Name of Manufacturer M/s. Martin Dopw Limited, Plot No. 37, Sector 19, Koramngi Industrial Area
Karachi, Pakistan
Manufacturer of API M/s Vision Pharmaceuticals
API Lot No. DLP376
Firm initially submitted stability data of Dexdow Delayed Release 30mg Capsules with API source
from M/s Vision Pharmaceuticals, but later submitted request for withdrawal of submitted stability studies
and said that they are changing the proposed source of API pellets of the said product, so it is requested to
hold the evaluation till submission of revised stability studies.
Decision: Registeration Board acceded firm’s request and deferred for submission of stability data as
per requirement decided in 293rd meeting
b. Verification of stability study data

375. Name and address of M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi
manufacturer / Applicant Creek Industrial Park, Karachi
Brand Name +Dosage Form + Glusimet XR 50/500 mg Tablets
Strength
Composition Each film-coated tablet contains:
Sitagliptin as Phosphate Monohydrate…50mg
Metformin HCl (extended release)…500mg
Diary No. Date of R& I & fee Dy No. 15370: 25.04.2018
PKR 20,000/-: 25.04.2018
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form 5
Finished product Specifications The firm has claimed manufacturer‘s specifications
Pack size & Demanded Price 5x10‘s; As per SRO
Approval status of product in JANUMET XR 50/500 sitagliptin (as phosphate
Reference Regulator Authorities monohydrate)/metformin hydrochloride 50 mg/500 mg
extended release tablet. TGA approved
Me-too status Tagipmet XR 50/500 Tablet. Reg. No. 84649
GMP status The firm was inspected on 10.07.2018, wherein the firm was
considered to be operating at good level of compliance with
GMP
Remarks of the Evaluator The firm was asked to submit stability data of three batches
conducted in Zone IV-A. The firm did not submit the same.
Previous Decision Deferred for submission of stability data of of product as per
decision of Registration
Board (M-290)
Drug Glusimet XR 50/500 mg Tablets
Name of Manufacturer M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi Creek Industrial Park,
Karachi
Manufacturer of API Sitagliptin as Phosphate Monohydrate: M/s Fuxin Long Rui Pharmaceutical Co.
Ltd, Fluoride Industrial park, Fuxin City, Liaoning Province.
Metformin HCl: M/s Aarti Drugs Limited, (Unit-II)
, India
API Lot No. Sitagliptin as Phosphate Monohydrate: M-20181222-D06-M06-05
Metformin HCl: MEF/18122466
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
Time Period Real time: 6 months
Accelerated:6 months
Frequency Accelerated: 0,3,,6 ( month)
Real Time: 0,3,6 (month)
Batch No. 068B19 069B19 070B19
No. of Batches 03
No.
1. COA of API. Sitagliptin as Phosphate Monohydrate: Copy of
COA (Batch# M-20181222-D06-M06-05) from
M/s Fuxin Long Rui pharmaceutical Co., Ltd.
China is submitted.
Metformin HCl:
Copy of COA (Batch# MEF/18122466) from
M/s Aarti Drugs (Unit-II) Limited, valsad Gujrat,
India is submitted.
2. Approval of API by regulatory authority of
country of origin or GMP certificate of API Sitagliptin as Phosphate Monohydrate: Copy
manufacturer issued by regulatory authority of Drug manufacturing license (License no.
of country of origin. Liao 20150233) for M/s Fuxin Long Rui

Pharmaceutical Co. Ltd, Fluoride Industrial
park, Fuxin City, Liaoning
Province issued by Liaoning Food and Drug
Administration of the People’s Republic of
China is submitted, valid upto 20-12-2022
Metformin HCl:
M/s Aarti Drugs (Unit-II) Limited: Copy of GMP
Certificate (Certificate#. 1801541) issued by Food
and Drug Control Administration, India valid upto
09-01-2020 is submitted
Yes
4. Data of 03 batches will be supported by
Yes
sheets etc.
5. Documents confirming import of API etc. Sitagliptin as Phosphate Monohydrate: Copy of
form 5 & Commercial Invoice No HN190223-G
Dated: 28-02-2019 from Beijing Sino Hanson
Import & Export is submitted & attested by ADC
(Karachi) dated ;19-07-2018.
( Decleration submitted that Fuxin long Rui inform
that their product would be exported under their
sister company Beijing Sino Hanson Import &
Export)
Metformin HCl:
Copy of form-5 & Commercial Invoice No:
EXP/1945/18-19-27/12/2018 Dated: 17-12-2018
from Aarti Drugs Limited, is submitted & attested
by ADC(Karachi) dated ;11-01-2019
Yes
Rules, 1978.
i. Applied technology of Active coating for Sitagliptin in which drug is loaded via coating solution on the
core tablet of metformin hydrochloride.
ii. Method development study to justify 10% overage of Sitagliptin in master formulation ( which is
required to be based on study/scientific rationale)
376. Name and address of M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi Creek
manufacturer / Applicant Industrial Park, Karachi
Brand Name +Dosage Form + Glusimet XR 50/1000 mg Tablets
Strength
Sitagliptin as Phosphate Monohydrate…50mg
Metformin HCl (extended release)…1000mg
PKR 20,000/-: 25.04.2018

Type of Form Form 5
Finished product Specifications The firm has claimed manufacturer‘s specifications
Pack size & Demanded Price 5x10‘s; As per SRO
Approval status of product in JANUMET XR 50/1000 sitagliptin (as phosphate
Reference Regulator Authorities monohydrate)/metformin hydrochloride 50 mg/500 mg
extended release tablet. TGA approved
Me-too status Tagipmet XR 50/1000 Tablet. Reg. No. 84650
GMP status The firm was inspected on 10.07.2018, wherein the firm was
considered to be operating at good level of compliance with
GMP
Remarks of the Evaluator The firm was asked to submit stability data of three batches
conducted in Zone IV-A. The firm did not submit the same.
Previous Decision Deferred for submission of stability data of product as per
decision of Registration
Board (M-290)
Drug Glusimet XR 50/1000 mg Tablets
Name of Manufacturer M/s Scilife Pharma Pvt Ltd. Plot # FD-57/58-A2, Korangi Creek Industrial Park,
Karachi
Manufacturer of API Sitagliptin as Phosphate Monohydrate: M/s Fuxin Long Rui Pharmaceutical Co.
Ltd, Fluoride Industrial park, Fuxin City, Liaoning Province.
Metformin HCl: M/s Aarti Drugs Limited, (Unit-II) , India
API Lot No. Sitagliptin as Phosphate Monohydrate: M-20181222-D06-M06-05
Metformin HCl: MEF/18122466
Description of Pack
Alu-Alu blister
Stability Storage Condition Real time : 30°C ± 2° C / 75% ± 5% RH
Accelerated:6 months
Frequency Accelerated: 0,3,,6 ( month)
Real Time: 0,3,6 (month)
Batch No. 071B19 072B19 073B19
No. of Batches 03
No.
9. COA of API. Sitagliptin as Phosphate Monohydrate: Copy of
COA (Batch# M-20181222-D06-M06-05) from
M/s Fuxin Long Rui pharmaceutical Co., Ltd.
China is submitted.
Metformin HCl:

Copy of COA (Batch# MEF/18122466) from
M/s Aarti Drugs (Unit-II) Limited, valsad Gujrat,
India is submitted.
10. Approval of API by regulatory authority of Sitagliptin as Phosphate Monohydrate: Copy
country of origin or GMP certificate of API of Drug manufacturing license (License no.
manufacturer issued by regulatory authority Liao 20150233) for M/s Fuxin Long Rui
of country of origin. Pharmaceutical Co. Ltd, Fluoride Industrial
park, Fuxin City, Liaoning
Province issued by Liaoning Food and Drug
Administration of the People’s Republic of
China is submitted, valid upto 20-12-2022
Metformin HCl:
M/s Aarti Drugs (Unit-II) Limited: Copy of GMP
Certificate (Certificate#. 1801541) issued by Food
and Drug Control Administration, India valid upto
09-01-2020 is submitted
Yes
Yes
sheets etc.
13. Documents confirming import of API etc. Sitagliptin as Phosphate Monohydrate: Copy of
form 5 & Commercial Invoice No HN190223-G
Dated: 28-02-2019 from Beijing Sino Hanson
Import & Export is submitted & attested by ADC
(Karachi) dated ;19-07-2018.
( Decleration submitted that Fuxin long Rui inform
that their product would be exported under their
sister company Beijing Sino Hanson Import &
Export)
Metformin HCl:
Copy of form-5 & Commercial Invoice No:
EXP/1945/18-19-27/12/2018 Dated: 17-12-2018
from Aarti Drugs Limited, is submitted & attested
by ADC(Karachi) dated ;11-01-2019
Yes
16. Commitment to follow Drug Specification
Yes
Rules, 1978.
i. Applied technology of Active coating for Sitagliptin in which drug is loaded via coating solution on the
core tablet of metformin hydrochloride.
ii. Method development study to justify 10% overage of Sitagliptin in master formulation ( which is
required to be based on study/scientific rationale)
Report on Investigation of Authenticity / Genuineness of data submitted for registration of
Glusimet XR (Sitagliptin + Metformin) 50mg/500mg & 50mg/1000mg Tablets by M/s Scilife
Pharma Pvt. Limited, Plot # FD-57/58-A2, KCIP, Karachi.

Reference No: F.1-2/2020-PEC dated 6th July, 2020.
Investigation Date and Time: 16th July, 2020. (Forenoon)
Investigation Site: Factory premises of M/s Scilife Pharma Pvt. Ltd. Plot # FD-57/58-
A2, KCIP, Karachi.
Background:
Chairman Registration Board considered the applications of M/s Scilife Pharma Pvt. Ltd. Plot #
FD-57/58-A2, KCIP, Karachi for registration of Glusimet XR (Sitagliptin + Metformin) 50mg/500mg
& 50mg/1000mg Tablets and constituted a three member panel to investigate the authenticity / genuineness of
data (import of raw material and stability data). Panel was advised to conduct inspection of the firm and
to submit report for further consideration. It was also advised to verify:
a. Applied technology of Active coating for Sitagliptin in which drug is loaded via coating solution on
the core tablet of metformin hydrochloride.
b. Product development study to justify 10%overage of Sitagliptin in master formulation (which is
required to be study/scientific rationale)
Composition of Panel:
1. Dr. Rafeeq Alam Khan, Dean Faculty of Pharmacy, Ziauddin University, Karachi. (Member
Registration Board).
2. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
3. Dr. Asfandyar Ajab Khan, Assistant Director, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:

The investigation was conducted by using a structured questionnaire of DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used and
retained, personnel involved, ongoing studies, printed data and integrity and security of data in
respective databases were also audited. The details of investigation may be summarized as under:
Glusimet XR 50/500mg and 50/1000mg tablets
Q. No. Question Observation by panel
1. Do you have documents Material used from commercial import of 50 kg Sitagliptin
confirming the import of API? Phosphate monohydrate imported from M/s Fuxin long
Rui Pharmaceutical co. Limited China taken ADC
approval 08-03-2019 Invoice No HN190228-C Dated: 28-
02-2019 and 2000 Kg Metformin HCl from M/s Aarti
Drugs ltd. India taken ADC approval 11-01-2019 Invoice
No. EXP/1945/18-19-27/12/2018.
2. What was the rationale behind There is proper vendor evaluation form being implemented
selecting the particular by the firm. The parameters included in this form are, DMF
manufacturer of API? status, GMP certificate, Stability data, provision of
reference standard of APIs and impurities standards etc.
The firm has evaluated on these criteria and both the APIs
qualified and selected accordingly.
3. Do you have documents The firm has documents confirming the import of USP
confirming the import of reference standards of Sitagliptin Phosphate and Metformin
reference standard and impurity HCl having ADC approval 14-11-2018 invoice no.
standards?

19BGST48458 Dated 23-10-2018 while impurity standard
received directly from manufacturer.
4. Do you have certificate of The firm has certificates of analysis of both APIs, USP
Analysis of the API, reference reference standards and impurity standard.
standards and impurity
standards?
5. Do you have any approval of Firm has GMP certificates of both APIs manufacturers
API or GMP certificate of API issued by regulatory authorities of their respective country
manufacturer issued by of origin.
regulatory authority of country
of origin?
6. Do you use API manufacturer Firm has used API manufacturer`s method of testing for
method of testing? Sitagliptin Phosphate monohydrate and Metformin HCl
has been tested as per USP monograph.
7. Do you have stability studies Firm has stability studies reports on both APIs provided by
reports on API? the respective manufacturers
8. If yes, whether the stability Stability testing performed as per Stability Indicating
testing have been performed as Methods (SIM) and impurities/related
per SIM method and substances/degradation products quantified for both APIs
degradation products have been by their respective manufacturers.
quantified?
9. Do you have method for The firm has used manufacturer methods for Sitagliptin
quantifying the impurities in the
Phosphate monohydrate and USP method for Metformin
API? HCl. Both the methods have the capability to quantifying
the respective impurities.
10. Do you have some remaining The firm has remaining quantities of both the APIs, their
quantities of the API, its reference standards and impurity standards.
reference standard and
impurities standards?
11. Have you used pharmaceutical Firm has used pharmaceutical grade excipients including
grade excipients? Hypromelloe, Microcrystalline Cellulose, Aerosil 200,
Sodium Stearyl Fumarate, HPMC 6CPS, Kaolin, PEG
6000, Povidone K30, Titanium dioxide, Talc, Propyl
Gallate and Opadry Blue.
12. Do you have documents Firm has documents confirming the import of excipients
confirming the import of the used except the one purchase from the local market. All
used excipients? necessary documents and certificate of analysis available
with them.
13. Do you have test reports and Firm has test reports and other records on the excipients
other records on the excipients used.
used?
14. Do you have written and Firm has written and authorized protocol for the
authorized development of the product.
protocol for the development of
the product?

15. Have you performed Drug- Firm has not performed Drug-excipients compatibility
excipients compatibility studies, as their formulation is similar to that of the
studies? innovator formulation (Janumet XR M/s MSD).
16. Have you performed Firm has performed comparative dissolution studies with
comparative dissolution studies? Janumet XR tablets manufactured by M/S. MSD. The
firm‘s product results are comparable to that of the
Reference product.
17. Do you have product Firm has equipped product development (R&D) section.
development (R&D) section
18. Do you have necessary Firm has necessary equipment for manufacturing of tablets
equipment’s available in in product development section. However, primary
product development section for packaging (blistering) performed in commercial production
development of the product? area.
19. Are the equipment in product The relevant equipment in product development section are
development section qualified? qualified.
20. Do you have proper Firm has proper maintenance / calibration / re-qualification
maintenance / calibration / re- program for the equipment used in PD section.
qualification program for the
equipment used in PD section?
21. Do you have qualified staff in The firm has trained and qualified staff in product
product development section development section with proper knowledge and training in
with proper knowledge and product development Including 03 Pharmacist, 05 Chemist
training in product and 01 Bio technologist.
development?
22. Have you manufactured three The firm has manufactured three stability batches for the
stability batches for the stability stability studies of Glusimet XR 50/500mg and Glusimet
studies of the product as XR 50/1000mg tablets respectively. The details are given
required? below,
Glusimet Glusimet
S. # 50/500mg 50/1000mg
B. No. B. Size B. No. B. Size
068B1 071B1
1 1000 1000
9 9
069B1 072B1
2 1000 1000
9 9
070B1 073B1
3 1000 1000
9 9
23. Do you have any criteria for The criteria for fixing the batch size of stability batches, as
fixing the batch size of stability informed by the firm, was based on the quantity required
batches? for stability study (i.e. number of tablets per testing
frequency and number of testing frequencies / intervals) and
minimum workingCapacity of the equipment.
24. Do you have complete record of Firm has completed record of production of stability
production of stability batches? batches.
25. Do you have protocols for Firm has approved detailed protocol for stability testing of
stability testing of stability stability batches.
batches?

26. Do you have developed and The Firm has developed and performed detailed analytical
validated the method for testing method validation studies for testing of stability batches.
of stability batches?
27. Do you have method transfer The firm has not conducted method transfer studies;
studies in case when the method however, they have validated their method properly.
of testing being used by your
firm is given by any other lab?
28. Do you have documents Firm has proper documents confirming the qualification of
confirming the qualification of equipment / instruments used in the test and analysis of API
equipment / instruments being and the finished drug.
used in the test and analysis of
API and the finished drug?
29. Do your method of analysis Method of analysis is stability indicating as supported by
stability indicating? force degradation studies.
30. Do your HPLC software is The HPLC software is 21CFR Compliant as per record of
21CFR compliant? the firm. Audit trail was active on all HPLC systems used
in the method validation and stability study. Individual user
log in and IDs were available.
31. Can you show Audit Trail Audit trail reports were available and randomly checked.
reports on product testing?
32. Do you have some remaining Firm has remaining quantities of stability batches.
quantities of degradation
products and stability batches?
33. Do you have stability batches Firm has completed the accelerated stability testing on the
kept on stability testing? three stability batches however; the real time stability
testing is in progress on all the three stability batches.
Currently 12 months study completed showing satisfactory
results.
34. Do you have valid calibration Firm has valid calibration status for the equipment used in
status for the equipment’s used production and analysis of the product.
in production and analysis?
35. Do proper and continuous Continuous power supply and monitoring are available for
monitoring and control are stability chambers.
available for stability chamber?
36. Do related manufacturing area, The related manufacturing area, equipment’s, personnel
equipment’s, personnel and and utilities be rated as GMP compliant.
utilities be rated as GMP
compliant?
37. Additional points:
a. Applied technology of a. Since in this formulation the core tablet of metformin
Active coating for hydrochloride developed as sustained release form,
Sitagliptin in which drug is while the Sitagliptin taken as immediate release form in
loaded via coating solution which Sitagliptin is loaded via coating solution on the
on the core tablet of sustained released core tablet of metformin
metformin hydrochloride. hydrochloride same as that of innovator formulation
JANUMET XR TABLETS.
b. Product development study
to justify 10%overage of

Sitagliptin in master b. Sitagliptin is immediate release part of the product in
formulation (which is which drug is loaded via coating solution on the
required to be sustained release core tablet of metformin
study/scientific rationale) hydrochloride. The coating process has the loss of the
coating solution as the coating solution remains in the
coating pan, adhere with the walls of the coating pan
and de-dusting through exhaust during the coting
process. The firm performed a study and developed
scientific rationale that the 10% overage of Sitagliptin
in the coating solution give the 100% Sitagliptin in the
final finished product. This 10% excess considered as
process loss rather than overages, which is satisfactory.
However the overage will be, minimized after
validation at commercial stage.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted
by the firm for registration of Glusimet XR (Sitagliptin + Metformin) 50mg/500mg &
50mg/1000mg Tablets is verifiable to satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are compliant to GMP
standards and are suited for the manufacturing of Glusimet XR (Sitagliptin + Metformin)
50mg/500mg & 50mg/1000mg Tablets.
Decision: Registration Board decided to approve registration of Glusimet XR (Sitagliptin + Metformin)

50mg/500mg & 50mg/1000mg Tablets with Innovator’s specifications by M/s Scilife Pharma.
Manufacturer will place first three production batches of both products on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
377. Name and address of M/s. Sami Phmaceuticals (Pvt) Limited, F-95, S.I.T.E.
manufacturer / Applicant Karachi.
Brand Name +Dosage Form + Provas AS Tablet
Strength
Paracetamol BP ………..325mg
Diphenhydramine HCl BP……….25mg
Phenylephrine HCl BP…………5mg
Diary No. Date of R& I & fee Dy.No. 15668 ; Dated:07-03-2019; Rs 50000/- 04-03-2019
Pharmacological Group Pain reliever
Antihistamine
Nasal decongestan
Approval status of product in Sever Allergy Plus Sinus Headach of USFDA OTC product.
Reference Regulator Authorities
GMP status GMP certificate issued dated: 14-06-2018
S.no Deficiencies/Shortcomings Reply by Firm
1. Reference provided is of a) In our case, reference drug of PROVAS-AS Tablets
OTC drug which is not is Severe Allergy Plus Sinus Headache Tablets,
which is an OTC drug holding NDC 49035-543

available in USFDA labeled by Wal-mart Stores Inc. In PORVAS-AS; all
database. active ingredients and their composition are the same
DISCLAIMER available is as of Severe Allergy Plus Sinus Headache (OTC
that: “OTC drugs are not drug) whose individual ingredients viz.,
reviewed and approved by Paracetamol, Diphenhydramine & Phenylephrine are
FDA, however they may be approved and available as individual monograph in
marketed if they comply with Federal Register
applicable regulations and
policies. FDA has not b) FDA's review of OTC drugs is primarily handled by
evaluated whether this CDER's Office of Drug Evaluation IV. There are
product complies”. more than 80 therapeutic categories of OTC drugs,
Clarify/Justify before further ranging from acne drug products to weight control
processing the case. drug products. As with prescription drugs, CDER
oversees OTC drugs to ensure that they are properly
labeled and that their benefits outweigh their risks
The Nonprescription Drug Advisory Committee

meets regularly to assist the agency in evaluating the
issues surrounding these products. This committee
has played a major role in the growth of prescription
to OTC switches in recent years
Sure there are over 300,000 marketed OTC drug

products, FDA reviews the active ingredients and
labeling of over 80 therapeutic classes of drugs, e.g.
analgesics, antacids, instead of individual drug
products. For each category, an OTC drug
monograph is developed and published in the Federal
Register. OTC drug monographs are a kind of "recipe
book" covering acceptable ingredients, doses,
formulations, and labeling. Many of these
monographs are found in section 300 of the Code of
Federal Regulations. Once a final monograph is
implemented, companies can make and market an
OTC product without the need for FDA pre-approval.
These monographs define the safety, effectiveness,
and labeling of all marketing OTC active ingredients
- Annexure-A
c) Please note new products that conform to a final

monograph may be marketed without further FDA
review. Those which do not conform are reviewed by
the New Drug Application process; a drug company
may also petition to change a final monograph to
include additional ingredients or to modify labeling
The NDC Product information enclosed herewith

contains FDA Application Number: part 341
(for OTC drugs, it is CFR citations corresponding to
appropriate Monograph e.g. “part 341”, for
unapproved drugs this field will be null) - Annexure
B
d) It is further clarified that an NDA may be submitted

for a direct-to-OTC drug product while many
FDA-approved OTC drug products (i.e., OTC
products that have an approved NDA) begin their
lifecycle as NDA-approved prescription drugs and
then eventually switch to OTC status under the NDA
provisions; it is commonly referred to as an Rx-to-
OTC switch; numerous products including
CLARITIN (Loratidine) NEXIUM (Esomeprazole)
etc. are further example of it; approved by FDA as
prescription drug initially and later switched to
OTC (reference enclosed herewith) - Annexure C
e) It is pertinent to add that DRAP is also following the

same principle in case of Iron preparations.
Copies of M-282, M-284, M-286 & M-287 minutes
of Drug Registration Board are enclosed in this
context for your kind perusal – Annexure D
Drug Provas AS Tablet
Name of Manufacturer M/s. Sami Phmaceuticals (Pvt) Limited, F-95, S.I.T.E. Karachi.
Manufacturer of API Paracetamol: Hebei Jiheng (Group) Pharmaceuticals co., Ltd China
Diphenhydramine HCl: Supriya Lifesciences Ltd, India
Phenylephrine HCl: Shenzen Oriental Pharmaceuticals co., Ltd China
API Lot No. Paracetamol : 31709016
Diphenhydramine HCl :SLL/DPH/1215076
Phenylephrine HCl : PEH-180101Y1
Description of Pack
Alu Blister
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5% RH
Frequency Accelerated: 0, 3,,6 (month)
Real Time: 0,3 ,6, 9 (month)
Batch No. Lab-01 Lab-02 Lab-03
Batch Size 2500 Tablet 2500 Tablet 2500 Tablet
Date of Initiation 07- 2018 07- 2018 07- 2018
No. of Batches 3
Date of Submission 07-03-2019 (Dy. No. 15668) 22-08-2019(DY. No. 15311)
No.
17. COA of API. Paracetamol: Copy of COA by Hebei Jiheng
(Group) Pharmaceuticals co., Ltd china is
submitted
Diphenhydramine HCl: Copy of COA by Supriya
Lifesciences Ltd, India is submitted
Phenylephrine HCl: Copy of COA by Shenzen
Oriental Pharmaceuticals co., Ltd China is
submitted

18. Approval of API by regulatory authority of Paracetamol:
country of origin or GMP certificate of API Copy of GMP Certificate No. HE20160062 by
manufacturer issued by regulatory authority Food & Drugs control Adminstration China. valid
of country of origin. till 14-11-2021.
Diphenhydramine HCl:
Copy of GMP Certificate No. NEW-WHO-
GMP/CERT/KD/67649/2018/11/25185 by Food &
Drugs control Adminstration , M.S, Bandra,
Mumbai. Maharashtra. India. valid till 04-10-2021.
Phenylephrine HCl:
Copy of GMP Certificate No. GD20150448 by Food
& Drugs control Adminstration China. valid till 07-
12-2022.
Yes
Yes
sheets etc.
21. Documents confirming import of API etc. Paracetamol:
Copy of Commercial Invoice No 1708ZP03
Dated: 19-10-2017 by Hebei Jiheng (Group)
Pharmaceuticals co., Ltd China is submitted
attested by ADC (Karachi) dated ;01-11-2017.
Copy of Commercial Invoice No
SLL/EXP/899/15-16 Dated: 25-03-2016 by Supriya
Lifesciences Ltd, India is submitted attested by
ADC(Karachi) dated ;13-04-2016.
Phenylephrine HCl:
Copy of Commercial Invoice No SZ-1804052
Dated: 11-04-2018 by Shenzen Oriental
Pharmaceuticals co., Ltd China is submitted attested
by ADC (Karachi) dated ;06-07-2018.
Yes
Rules, 1978.
S.no Deficiencies/Shortcomings Reply by Firm

1. GMP certificate of source of Submitted.
all API(s)
2. Unidentified peaks & This product conatins 3 API’s i.e Paracetamol, Diphenhydramine
inverted peaks are appearing HCl and Phenyephrine HCl the identified peaks are response of
in Phenylephrine assay and paracetamol and Diphenhydramine HCl
dissolution in all time points .
Please justify.

3. Retention time are varying on Slight variation in the retention time may be observed due to
different time points for same multiple factors but not affecting the result.
sample .Please clarify. We have done the complete method validation of this testing
method as per USP/ICH and method comply all the parametrs.
4. Jusification is required for Dissolution parameters are extracted from pharmacopeal

dissolution parameters monograph of similar product that contains Acetaminophen
including (Paracetamol), diphenhydramine and Pseudoephedrine tablet
i. Dissolution
apparatus
ii. RPM
iii. Dissolution
parameters
iv. Sampling time
5. Jusification is required for Method of analysis for Assay of Paracetamol and

assay of paracetamol, Diphenhydramine are derived from the pjharmacopeal method of
Diphenhydramine and Acetaminophen (Paracetamol), diphenhydraime and
phenylephrine as you have Pseudoephedrine while for phenylephrine HCl, method of raw
used two testing method material is used.

The firm has requested for Exemption from On-site Investigation of their submitted stability data and
provided the following documents in conjunction with the checklist approved by the Registration Board in
its 278th Meeting:
1. Reference of last onsite panel inspection for Registration Board approved Tefod 25mg Tablets in its
instant dosage form conducted during last two 288th Meeting
years.  Date of Inspection: 28-01-2019
 The HPLC is 21CFR Compliant.
 Audit trail on the testing were available
2. Documents for the procurement of API with Paracetamol:
approval from DRAP (in case of import). Copy of Commercial Invoice No 1708ZP03
Dated: 19-10-2017 by Hebei Jiheng (Group)
Pharmaceuticals co., Ltd China is submitted attested
by ADC (Karachi) dated ;01-11-2017.
Copy of Commercial Invoice No SLL/EXP/899/15-
16 Dated: 25-03-2016 by Supriya Lifesciences Ltd,
India is submitted attested by ADC(Karachi) dated ;03-
04-2016.
Phenylephrine HCl:
Copy of Commercial Invoice No SZ-1804052
Dated: 11-04-2018 by Shenzen Oriental
Pharmaceuticals co., Ltd China is submitted attested by
ADC (Karachi) dated ;06-07-2018.
3. Documents for the procurement of reference The firm has submitted photocopy of Invoices for the
standard and impurity standards. procurement of reference standard and impurity
standards.
4. Approval of API/ DML/GMP certificate of Paracetamol:
API manufacturer issued by regulatory Copy of GMP Certificate No. HE20160062 by Food
authority of country of origin. & Drugs control Adminstration China. valid till 14-
11-2021.

Copy of GMP Certificate No. NEW-WHO-
GMP/CERT/KD/67649/2018/11/25185 by Food &
Drugs control Adminstration , M.S, Bandra, Mumbai.
Maharashtra. India. valid till 04-10-2021.
Phenylephrine HCl:
Copy of GMP Certificate No. GD20150448 by Food &
Drugs control Adminstration China. valid till 07-12-
2022.
5. Mechanism for Vendor pre-qualification The firm has submitted copy of vender
evaluation questionnaire for vender pre-
qualification along with filled questionnaire from
all APIs manufacturers.
6. Certificate of analysis of the API, reference The firm has submitted
standards and impurity standards COA of API:
Paracetamol : 31709016
Diphenhydramine HCl :SLL/DPH/1215076
Phenylephrine HCl : PEH-180101Y1
COA of Reference Standard:
 Paracetamol CRS
 Phenyephrine Hydrochloride CRS
 Diphenhydramine Hydrochloride CRS
 Diphenhydramine Impurity A CRS
Leaflet from EDQM submitted.
 Acetaminophen related Compound J Lot No#
LRAA9623 COA by sigma- Aldrich
submitted.
 Acetaminophen Related Compond F Lot No#
F0M236
 M-Aminophenol Lot G0J290
Leaflet from USP Submitted.
7. Documents for the procurement of excipients The firm has submitted commercial invoices &
used in product development? COAs of all the excipients used in formulation of
Provas As Tablet, from relevant manufacturers
8. List of qualified staff involved in product The firm has submitted photocopy of List of qualified
development with relevant experience. staff involved in product development
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of Development
development & stability testing of trial Protocol for manufacturing
batches.
10. Complete batch manufacturing record of three The firm has submitted copy of Trial batch
stability batches. manufacturing record.
Details are as under:
Provas AS Tablet
Batch No. Bach size Mfg.
Started
Lab-01 2500 tablets 06-2018
Lab-02 2500 tablets 06-2018
Lab-03 2500 tablets 06-2018

11. Record of remaining quantities of stability The firm has submitted reconciliation sheet
batches. mentioning remaining quantity of three trial batches.
The detail is as under:
Bat Total no. of Used Remaini
ch tablets for quantities ng
No. stability quantitie
s
La 1655 440 1215
b-
01
La 1655 440 1215
b-
02
La 1655 440 1215
b-
03
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger
and humidity monitoring of stability chambers record for Accelerated stability chamber from
(real time and accelerated) 12-07-2018 to 18-01-2019 and for Real Time
stability chamber starting from 12-07-2018 to
18-01-2019
13. Method used for analysis of API along with The firm has submitted photocopy of method used for
COA. analysis of APIs along with COA.
14. Method used for analysis of FPP & complete The firm has submitted photocopy of Finished Product
record of testing of stability batches (i.e. Specifications and Testing Method of Complete record
chromatograms, lab reports, raw data sheets of testing of stability batches (i.e. chromatograms, lab
etc.) reports, raw data sheets etc.) are submitted with 06 &
06 months stability data Accelerated & Real Time
respectively.
15. Reports of stability studies of API from Paracetamol: The firm has submitted copy of
manufacturer. accelerated, 06 Months (40°C ± 2°C & 75±5%RH) &
long term, 06 Months (30°C ± 2°C & 75±5%RH)
stability study reports of 03 batches.
Diphenhydramine HCl: The firm has submitted copy
of accelerated, 06 Months (40°C ± 2°C & 75±5%RH)
& long term, 06 Months (30°C ± 2°C & 75±5%RH)
Phenylephrine HCl : The firm has submitted copy of
accelerated, 06 Months (40°C ± 2°C & 75±5%RH) &
long term, 06 Months (30°C ± 2°C & 75±5%RH)
16. Analysis reports for excipients used. The firm has submitted copy of COAs for the
excipients used in the applied formulation
17. Drug-excipients compatibility studies. The firm has submitted Drug-excipients compatibility
studies.
18. Record of comparative dissolution data. Firm has submitted Comparative dissolution study of
their product with Innovator’s Brand “ Brilinta”.
The details are as follows:
Feature Reference Product of

product High-Q
Brand name Equate sever Provas AS
Allergy Plus Tablet
Sinus
Headach
Batch No. P111532 Lab-01
Comparative dissolution studies have been performed

in following mediums:
1. pH 1.2 HCl buffer
2. pH 4.5 Acetate buffer
3. pH 6.8 Phosphate buffer
19. Compliance Record of HPLC software Firm has submitted audit trail reports for complete
21CFR & audit trail reports on product stability studies analysis of three batches
testing.
Remarks of Evaluator:
S.n Deficiencies/Shortcomings Reply by Firm

o
1. Composition of Paracetamol 326.7951mg & The quantity of API(Paracetamol) as per label is
Diphenhydramine 25.16mg while label claim 325mg/tablet whereas the calculated quanitity of
for Paracetamol 325mg & Diphenhydramine API is 326.7951mg/tablet which is according to
25mg. Clarify. its potency. However, the quanitity of API per
tablet will remain same as of label claim i.e,
325mg/tablet.
The quantity of API(Paracetamol) as per label
claim is 25mg/tablet whereas the calculated
quanitity of API is 25.16mg/tablet which is
according to its potency. However, the quanitity
of API per tablet will remain same as of label
claim i.e, 25mg/tablet.
2. Authorized P rotocols/SOP for the Submitted
development & stability testing of trial
batches not submitted.
3. COA of reference standards and impurity Firm submitted leaflet from EDQM and
standards not submitted. submit reply that EDQM does not provide
certificate of analysis for European
Pharmacopeia reference standard. The EDQM
provides an information leaflet that contains
all of the information need to carry out the
testes and assays described in the related
monographs
Two different leaflets are being attached
therein, Potency has been provided in one
leaflet whereas another leaflet doesn’t
mention potency.
4. COA of maiz starch not signed by COA is generated by system and needs no
manufacturer. sign.
5. You have not performed uniformity of dosage Content uniformity testing performed in july
unit by content uniformity, as recommended 2018 of 3 batches Lab-01,Lab-02& Lab-03
by USP General Chapter <905> throughout submitted.
stability studies. Justification shall be
submitted in this regard.
6. F2 calculation for phenylephrine in F2 calculation for phenylephrine in
comparative dissolution not submitted. comparative dissolution submitted.
7. Accelerated stability studies for API Submitted
Phenylephrine according to Zone IV-A not
submitted.
8. Accelerated stability & long term studies for Because the Accelerated stability testing
Paracetamol are of different batches. Clarify. condition of IV zone B is same as the
Accelerated stability testing condition of I and
II ( temperature 40°C ± 2°C & 75±5%RH) so for
Accelerated stability testing , we didn’t do for
Batch 011703029/011710020/011710019.
9. In accelerated stability , auditrail for assay Submitted.
at 4th month not submitted..
Previous Decision(M-293):
Registration board decided to consider the case after onsite inspection by the panel for verification of
authenticity of submitted stability studies data due to following observation in the stability data:
 Unidentified peaks & inverted peaks are appearing in Phenylephrine assay and dissolution in all time
points.
 Retention time are varying on different time points for same sample.
Report on Investigation of Authenticity / Genuineness of data submitted for registration of
Provas AS (Paracetamol, Phenylephrine HCl and Diphenhydramine HCl) Tablets by M/s Sami
Pharmaceuticals Pvt. Limited, Karachi.
Reference No: F.1-2/2020-PEC dated 18th February, 2020.
Investigation Date and Time: 28th June, 2020. (Forenoon)
Investigation Site: Factory premises of M/s Sami Pharmaceuticals Pvt. Ltd.
Karachi.
Background:
Registration Board in its 293rd meeting considered the applications of M/s. Sami
Pharmaceuticals (Pvt.) Ltd., Karachi for registration of Provas AS (Paracetamol, Phenylephrine HCl
and Diphenhydramine HCl) Tablets and constituted a two member panel to investigate the
authenticity / genuineness of data (import of raw material and stability data). Panel was advised to
conduct inspection of the firm and to submit report for further consideration.
1. Unidentified peaks and inverted peaks are appearing in Phenylephrine assay and dissolution in
all time points.
2. Retention time are varying in different time points for same sample.
1. Dr. Sidra Yasmeen, Assistant Director, Drug Regulatory Authority of Pakistan, Karachi.
2. Dr. Affan Ali Qureshi, Assistant Director, CDL, DRAP, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability
data), manufacturing of stability batches and stability studies on these batches.

The investigation was conducted by using a structured questionnaire of DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used
and retained, personnel involved, ongoing studies, printed data and integrity and security of data in
respective databases were also audited. The details of investigation may be summarized as under:
Details of Investigation:
S.
Questions Remarks
No.

1. Do you have documents Recei
Batch Invoice
confirming the import API API Supplier ved
No No
including approval from DRAP? Qty.
Hebei
Jiheng
(Group) 3170901 1708ZP 5000
Paracetamol
Pharmaceut 6 03 Kg
ical Co.
Ltd.
Shenzhen
Phenylephrin
Oriental PEH-
e SZ- 100g
Pharmaceut 180101
Hydrochlorid 1804052 m
ical Co. Y1
e
Ltd.
Supriya SLL/DP SLL/EX
Diphenhydra 0.700
Lifescience H/12150 P/899/1
mine kg
Ltd. 76 5-16
The firm has obtained proper approval from DRAP Karachi.
2. What was the rationale behind There is proper vendor evaluation process being implemented
selecting the particular by the firm and the rationale behind vendor selection is
manufacturer of API? controlled through:
 Desktop Audit checklist
 GMP approval by competent authority
3. Do you have documents The firm has imported the following reference standard and
confirming the import of API impurities standard.
reference standard and impurity Reference Supplier Batch Quantity
standards? |Standard /Source No.
Acetaminophen USP F0M236 50mg
related
compound F
m-Aminophenol USP G0J290 300mg

Paracetamol EDQM Batch 50mg
CRS No. 4
Phenylephrine EDQM Batch 2mg
HCl for peak No. 5
identification
CRS
Phenylephrine EDQM Batch 50mg

HCl CRS No. 3
Diphenhydramin EDQM Batch 100mg
e HCl CRS No. 1
Diphenhydramin EDQM Batch 10mg
e Impurity A No. 4
CRS

4- Sigma LRAA96 1g
Chloroacetanilid Aldrich 23
e
(Acetaminophen
RCJ)
pharmaceutical
secondary
standard
4. Do you have certificate of Firm have certificates of analysis for API, reference standards
Analysis of the API, reference and impurity standards
standards and impurity
standards?
5. Do you have GMP certificate of Firm has GMP certificate for Paracetamol of M/s. Hebei
APIs manufacturer issued by Jiheng (Group) Pharmaceutical Co. Ltd. issued by Hubei
regulatory authority of country ofFood and Drug administration – China,
origin? Diphenhydramine HCl of M/s. Supriya Lifescience Ltd
issued by M/S. Bandra (E) Mumbai. Maharashtra state -India.
Phenylephrine Hydrochloride of M/s. Shenzhen Oriental
Pharmaceutical Co. Ltd issued by Food and Drug
administration – China.
6. Do you use APIs manufacturer Firm has used pharmacopoieal method of testing for APIs.
method of testing for testing
APIs?
7. Do you have stability studies The firm has stability studies report of APIs, Paracetamol,
reports on API? Phenylephrine HCl, Diphenhydramine HCl conducted by API
manufacturer.
8. If yes, whether the stability The manufacturer of API has performed the stability studies of
testing has been performed as per APIs as per SIM Method and the Related Substance have been
SIM method and degradation quantified by the API manufacturer
products have been quantified?
9. Do you have method for The firm has methods for quantifying the impurities in API.
quantifying the impurities in the
API?
10. Do you have some remaining The firm has 440g of Diphenhydramine HCl and 44g
quantities of the API, its Phenylephrine HCl but has consumed all reference standards
reference standard and impurities and impurity standards.
standards?
11. Have you used pharmaceutical The firm has used pharmaceutical grade excipients
grade excipients?
12. Do you have documents The firm has documents confirming the import of the used
confirming the import of the used excipients.
excipients?
13. Do you have test reports and The firm has test reports and other records on the excipients.
other records on the excipients
used?
14. Do you have written and The firm has written and authorized protocol for the
authorized protocols for the development of Provas AS Tablets.
development of Provas AS
Tablets.?
15. Have you performed Drug- The firm has used same excipients as used by the innovator.
excipients compatibility studies? However, compatibility studies were also performed for
maximum assurance.

16. Have you performed comparative The firm has performed comparative studies with innovator
dissolution studies? Equate (Severe Allergy Plus Sinus Headache) Tablet,
distributed by Wal-Mart Store Inc, Bentonville, AR 72716.
17. Do you have product The firm has product development (R&D) Section with the
development (R&D) section facility of manufacturing and Analysis of R&D products.
18. Do you have necessary The firm has necessary equipment available in product
equipment available in product development section for development of Provas AS Tablet.
development section for
development of Provas AS
Tablets.?
19. Are the equipments in product The available equipment in Product Development are
development section qualified? qualified.
20. Do you have proper maintenance There is proper maintenance / calibration program for the
/ calibration / re-qualification equipment used in PD section.
program for the equipment used
in PD section?
21. Do you have qualified staff in The firm has 10 Pharmacists and 01 Chemists for Product
product development section Development Formulation and 6 Pharmacist and 4 Chemists
with proper knowledge and in Analytical section.
training in product development?
22. Have you manufactured three The firm has manufactured three stability batches of each 2500
stability batches for the stabilitytablets.
studies of Provas AS Tablets.as Provas AS Tablet
required? Batch No Date of Mfg. Expiry Date
Lab-01 06-2018 05-2020
Lab-02 06-2018 05-2020
Lab-03 06-2018 05-2020
23. Do you have any criteria for The criteria for fixing the batch size of stability batches are
fixing the batch size of stability the number of Tablets per testing frequencies.
batches?
24. Do you have complete record of The firm has complete record for the stability batches of
production of stability batches? Provas AS Tablet.
25. Do you have protocols for The firm has protocols for testing of stability batches.
stability testing of stability
batches?
26. Do you have developed and The firm has developed and validated method of testing of
validated the method for testing finish product Provas AS Tablet, based on method of testing
of stability batches? of API.
27. Do you have method transfer Method transfer studies are not applicable as the firm
studies in case when the method developed and validated their own method.
of testing being used by your firm
is given by any other lab?
28. Do you have documents The firm has proper documents confirming the qualification of
confirming the qualification of equipment / instruments being used in the test and analysis of
equipments / instruments being the Provas AS tablets.
used in the test and analysis of
API and the finished drug?
29. Does your method of analysis The firm’s Method of analysis is Stability indicating
stability indicate? supported by forced degradation.
30. Do your HPLC software 21CFR The HPLC software’s are 21CFR compliant.
Compliant?
31. Can you show Audit trail reports? The firm has audit trail Reports on testing.

32. Do you have some remaining The firm has some remaining quantities of stability batches
quantities of degradation only.
products and stability batches?
33. Do you have stability batches The firm has three stability batches kept on stability for Real
kept on stability testing? time stability testing. 18 Months Real Time and 6 months
Accelerated stability studies has been completed.
34. Do you have valid calibration The firm has valid calibration status for the equipment used in
status for the equipments used in Provas AS Tablets production and analysis.
Provas AS Tablets production
and analysis?
35. Do proper and continuous Adequate monitoring and control are available for stability
monitoring and control are chamber. Chambers are controlled and monitored through
available for stability chamber? 21CFR compliant software.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and utilities
equipment, personnel and are rated as GMP compliant.
utilities be rated as GMP
compliant?
37. Any other query raised by
Registration Board: 1. The panel reviewed the investigation performed by the
1. Unidentified peaks and firm which concluded as on the basis of study the
inverted peaks are unidentified peaks are of Paracetamol and
appearing in Diphenhydramine HCl, which are also observed in the
Phenylephrine assay and submitted dossier. However, the estimation of
dissolution in all time Phenylephrine HCl was not affected due to these
points. peaks.
2. The panel also reviewed investigation of the firm for

varying retention time, the firm has performed root
cause analysis and concluded as the change in
retention time was due to addition of freshly prepared
2. Retention time are mobile phase due to less amount of mobile phase, the
varying in different time firm changed the protocol and started preparing
points for same sample. double amount of mobile phase initially so that such
events may not occur again.
The panel reviewed the data of the firm for later time
points of real time stability studies and found the
product stable and satisfactory.
Conclusions:
1. On the basis of risk-based approach the genuineness / authenticity of stability data
submitted by the firm for registration of Provas AS (Paracetamol, Phenylephrine HCl and
Diphenhydramine HCl) Tablets is verifiable to highly satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are compliant are
suited for the manufacturing of Provas AS Tablets.
Decision: Registration Board decided to approve registration of Provas AS Tablets(Paracetamol
..325mg, Diphenhydramine HCl ..25mg, Phenylephrine HCl ..5mg).with Innovator’s specifications by
M/s Sami Phmaceuticals. Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Case no. 05 Miscellaneous cases

Brand Name +Dosage Form + Oxab 150mg Tablet
Strength
Oxcarbazepine…….150mg
Diary No. Date of R& I & fee Dy.No. 16639 dated 07-05-2018 Rs.20,000/- Dated 07-05-
2018
Type of Form Form 5
Approval status of product in MHRA approved
Me-too status (with strength and Telox 150mg Tablets of M/S Platinum Pharmaceutical,
dosage form)
Deferred for updated status of GMP of the firm form QA &
LT division as inspection report submitted by firm does not
conclude GMP compliant status. (M-290)
following the GMP guidelines as per Drugs, Act, 1976 and
rules framed there under. Based on the area inspected the
people met and document reviewed and considering the
findings of inspection of M/s Saydon Peshawar is
considered to be operated at acceptable level of compliance
with GMP guideline as per Drugs, Act, 1976 and rules
framed there under.
Previous Decision (M-293): Decision was not recorded.
Decision: Approved.
Agenda of Evaluator PEC-XI

New cases
379. Name and address of manufacture / M/s Jawa Pharmaceuticals Pvt Ltd
Applicant 112/10, Quaid e Azam Industrial Area, Kot Lakhpat,
Lahore
Brand Name + Dosage Form and Strength Jfenac P 75mg Tablet
Diclofenac potassium…..75mg
Dairy No. date of R &I fee Form-5 Dy.No 7521 dated 21-02-2019 Rs.20,000/-
Dated 21-02-2019
Type of form Form 5
Finished product specifications USP
Pack size and Demand Price 2x10’s; As per SRO
Me-too-status Valron-P 75 tablets by M/s Venus Pharma
(Reg#078831)
GMP Status The firm was inspected on 18-07-2017 and conclusionof
inspection was:
Based on areas inspected, documents checked and
interaction with the management the firm M/s Jawa
Pharmaceuticals Pvt Ltd Lahore was considered to be
operating at the satisfactory level of GMP compliance
as per Drugs, Act, 1976 and rules framed thereunder.

Remark of the Evaluator XI  The firm provided the evidence of cataflam tablets
USFDA approved which could not be verified in the
applied strength
 The firm revised master formulation and replaced
methylene chloride with IPA in coating composition.
 Upon clarification for addition of 5% overage the
firm replied that they use 5% excess of active
material to make their product more effective and
stable.
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
Lahore
Brand Name + Dosage Form and Strength Jfenac 100mg SR Tablet
Dated 21-02-2019
Type of form Form 5
Approval status of product in Reference VOLTAREN-XR (diclofenac sodium film coated
Regulatory Authorities extended-release) tablets 100mg, (USFDA Approved)
Discontinued **Federal Register determination that
product was not discontinued or withdrawn for safety or
efficacy reasons**
Me-too-status Heltron SR Tablets 100mg by M/s Heal
Pharmaceuticals (Reg#84235)
inspection was:
Remark of the Evaluator XI
 The firm have revised the label claim from uncoated
to film coated tablets along with submission of Rs
5000/- on deposite slip No. 2026317 dated
03.06.2020. The correct label claim is;
Each film coated extended release Tablet Contains:
Diclofenac Sodium…..…100mg
stable.
Decision: Deferred for justification of addition of 5% overage in the formulation.
Lahore
Brand Name + Dosage Form and Strength Joxycycline 100mg Capsule
Doxycycline (as Hyclate)..…100mg
Dated 21-02-2019

Type of form Form 5
Pack size and Demand Price 1x10’s, 10x10’s; As per SRO
Approval status of product in Reference Doxycycline 100mg Capsules MHRA Approved.
Me-too-status Medox Capsule 100mg by M/s Maxitech, (Reg#84781)
inspection was:
Remark of the Evaluator XI  Upon clarification for addition of 5% overage the
stable.
Lahore
Brand Name + Dosage Form and Strength Jincomycin 500mg Capsule
Lincomycin (as HCl)…..500mg
Dated 21-02-2019
Pharmacological Group Antibacterials For Systemic Use
Type of form Form 5
Approval status of product in Reference Lincocine 500mg Capsule ANSM France approved
Me-too-status F-Linco 500mg capsule by M/s Fresh Pharmaceuticals
(Reg#080450)
inspection was:
stable.
383. Name and address of manufacture / M/s Pakistan Pharmaceutical Products Pvt Ltd.
Applicant D-122, Sindh Industrial Trading Estate, Karachi
Brand Name + Dosage Form and Strength Misal 50mg Tablet
Amisulpride…..50mg
Dated 06-02-2019
Pharmacological Group Antipsychotics (Benzamides)
Type of form Form 5
Finished product specifications BP
Approval status of product in Reference Amisulpride 50mg Tablets MHRA Approved
Me-too-status Amilia 50mg Tablet by M/s Evolution Pharmaceuticals
(Reg#101611)
GMP Status The firm was inspected on 1-10-2018 and conclusion of
inspection was:
The firm is found to be complying at a good level of
GMP compliance at the time of inspection. Continuous
improvement for procedures shall be followed in letter
and spirit as cGMP guidelines per the Drugs Act, 1976,
Drap Act 2012 and rules framed there under.
Remark of the Evaluator XI  The firm revised the 1st page of form 5 as per
prescribed format.
 The firm submitted complete manufacturing outline
mentioning all the steps (compression, blistering and
packing processes).
Decision: Approved.
Brand Name + Dosage Form and Strength Misal 100mg Tablet
Amisulpride……100mg
Dated 06-02-2019
Type of form Form 5
Approval status of product in Reference Amisulpride 100mg Tablets MHRA Approved
Me-too-status Amilia 100mg Tablet by M/s Evolution
inspection was:
prescribed format.
mentioning all the steps (compression, blistering and
packing processes).
Decision: Approved.
Brand Name + Dosage Form and Strength Epezil Tablet 10mg
Donepezil HCl…..10mg
Dated 25-02-2019
Pharmacological Group Anticholinestrase
Type of form Form 5

Approval status of product in Reference ARICEPT (5mg, 10mg, 23mg) film-coated USFDA
Me-too-status Nepezil 10mg Tablet by M/s Genix Pharma
(Reg#083286)
inspection was:
approved format.
mentioning all the steps (compression, coating,
blistering and packing processes).
Decision: Approved.
Brand Name + Dosage Form and Strength Epezil Tablet 5mg
Donepezil HCl..…5mg
Dated 25-02-2019
Pharmacological Group Anticholinestrase
Type of form Form 5
Approval status of product in Reference ARICEPT (5mg, 10mg, 23mg) film-coated USFDA
Me-too-status Nepezil 5mg Tablet by M/s Genix Pharma
(Reg#083285)
inspection was:
and spirit as Cgmp GUIDELINES PER THE Drugs Act,
1976, Drap Act 2012 and rules framed there under.
approved format.
Decision: Approved.
Brand Name + Dosage Form and Strength Empaglu Tablet 10mg
Empagliflozin……10mg
Dated 25-02-2019
Pharmacological Group Blood Glucose Lowering Drugs, Excl. Insulins
Type of form Form 5
Finished product specifications Manufacturer’s specifications

Approval status of product in Reference JARDIANCE (10mg, 25mg) film-coated tablets
Regulatory Authorities USFDA Approved
Me-too-status Empoli 10mg Tablet by M/s Sami Pharmaceuticals
(Reg#098702)
inspection was:
and spirit as Cgmp GUIDELINES PER THE Drugs Act,
1976, Drap Act 2012 and rules framed there under.
 Submission of stability studies data of three batches
as per Requirements of Registration Board decision
of 293rd meeting is required.
 The firm submitted undertaking at the end of form 5
duly signed by the technical persons.
Decision: Deferred for submission of stability study data as per guidelines provided in 293rd
meeting of Registration Board.
388. Name and address of manufacture / M/s Cunningham Pharmaceuticals Pvt Ltd.
Applicant Plot # 81, Sunder Industrial Estate, Raiwind Road
Lahore, Pakistan
Brand Name + Dosage Form and Strength Cuflozin Tablet 10mg
Dapagliflozin as Propanediol Monohydrate……10mg
Dated 14-02-2019
Type of form Form 5
Pack size and Demand Price As per SRO
Approval status of product in Reference Farxiga (5mg, 10mg) film coated Tablets USFDA
Me-too-status Xiga 10mg tablets by CCL Pharmaceuticals
(Reg#090505)
GMP Status GMP Certificate issued on 12-03-2018 based upon
inspection conducted on 31.01.2018
Remark of the Evaluator XI  The firm replied that stability studies data of three
batches as per Requirements of Registration Board
decision of 293rd meeting for the applied product is
in process.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Cuflozin Tablet 5mg
Dapagliflozin as Propanediol Monohydrate..…5mg
Dated 14-02-2019
Type of form Form 5
Approval status of product in Reference Farxiga (5mg, 10mg) film coated Tablets USFDA
Me-too-status Xiga 5mg tablets by CCL Pharmaceuticals
(Reg#090504)
decision of 293rd meeting for the applied product is
in process.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Culans 15mg Capsule
Lansoprazole (as Enteric coated pellets
8.5%)……15mg
Source of pellets: Vision Pharmaceuticals
Dated 27-02-2019
Type of form Form 5
Approval status of product in Reference Lansoprazole 15mg gastro-resistant capsules MHRA
Me-too-status Arcozol Capsules 15mg of M/s Pakistan
Pharmaceutical (Reg#32239)
Remark of the Evaluator XI  The firm submitted valid GMP certificate of supplier
of pellets (vision Pharmaceuticals) along with COA
and stability studies data of three batches
Decision: Approved.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Culans 30mg Capsule
Lansoprazole (as Enteric coated pellets
22.5%)……30mg
Source of pellets: Vision Pharmaceuticals
Dated 27-02-2019
Type of form Form 5
Approval status of product in Reference Lansoprazole 30mg gastro-resistant capsules MHRA
Me-too-status Arcozol Capsules 30mg of M/s Pakistan
Pharmaceutical (Reg#32240)

Remark of the Evaluator XI  The firm submitted valid GMP certificate of supplier
of pellets (vision Pharmaceuticals) along with COA
and stability studies data of three batches
Decision: Approved.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Betalol 5mg Tablet
Nebivolol (as HCl)..…5mg
Dated 27-02-2019
Pharmacological Group Beta blocking agents, selective
Type of form Form 5
Approval status of product in Reference BYSTOLIC (2.5mg, 5mg, 10mg, 20mg) tablets
Me-too-status Nebil 5mg Tablets of M/s Getz Pharma Pakistan
(Reg.#061345)
Remark of the Evaluator XI  The firm informed that they have submitted SMP
(summary of manufacturing procedure) of coated
tablet mistakenly and submitted revised SMP of the
tablet which doesnot show coating procedure.
Decision: Approved with innovator’s specifications.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Betalol 10mg Tablet
Nebivolol (as HCl)..…10mg
Dated 27-02-2019
Type of form Form 5
Me-too-status Nebil 10mg Tablets Tablets of M/s Getz Pharma
Pakistan (Reg.#061346)
 The firm informed that they have submitted SMP of
coated tablet mistakenly and submitted revised SMP
of the tablet which doesnot show coating procedure.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Betalol 2.5mg Tablet
Nebivolol (as HCl)……2.5mg
Dated 27-02-2019
Type of form Form 5
Me-too-status Nebil 2.5mg Tablets of M/s Getz Pharma
(Reg.#061344)
Remark of the Evaluator XI  The firm informed that they have submitted SMP of
Lahore, Pakistan
Brand Name + Dosage Form and Strength Cunilor 90mg Tablet
Ticagrelor..…90mg
Dated 14-02-2019
Pharmacological Group Platelet aggregation inhibitors excl. heparin
Type of form Form 5
Approval status of product in Reference BRILINTA (60mg, 90 mg) film-coated tablet USFDA
Me-too-status Virata 90mg tablets (didn’t depict coating) by M/s
CCL Pharmaceuticals (Reg#090349)
decision of 293rd meeting for the applied product is in
process.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Tranmic 500mg Tablet
Tranexamic Acid..…500mg
Dated 14-02-2019
Pharmacological Group Antifibrinolytics
Type of form Form 5
Approval status of product in Reference Tranexamic Acid 500mg coated tablet MHRA
Me-too-status Traumax Tablet 500mg of M/s Siza International (Reg.
#024787)

Remark of the Evaluator XI  The firm has claimed manufacturer’s specifications
but the official monograph is available in BP.
 The firm informed that they have submitted SMP of
Decision: Approved.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Ketafast 50mg/ml Injection
Ketamine (as HCl)..…50mg
Dated 27-02-2019
Type of form Form 5
Pack size and Demand Price 10ml; As per SRO
Approval status of product in Reference Ketalar 50mg/ml Injection, of MHRA approved
Me-too-status Ketalite Injection 50mg/ml by M/s Elite
Remark of the Evaluator XI 
Decision: Approved.
Lahore, Pakistan
Brand Name + Dosage Form and Strength Ketafast 10mg/ml Injection
Ketamine (as HCl)..…10mg
Dated 27-02-2019
Type of form Form 5
Approval status of product in Reference Ketalar 10mg/ml Injection, of MHRA approved
Me-too-status KANOX INJECTION 10mg/ml by M/s Duo Pharma
Reg#21996)
Decision: Approved.
399. Name and address of manufacture / M/s Werrick Pahrmaceuticals.
Applicant 216-217,I-10/3, Industrial Area, Islamabad
Brand Name + Dosage Form and Strength Bud-Air Dry Powder Inhalation 400/12mcg capsule
Composition Each DPI Capsule Contains:
Budesonide……400mcg
Formoterol fumarate dihydrate……12mcg
Dated 14-02-2019
Pharmacological Group Glucocorticosteroid/Selective β2 adrenoceptor
agonist
Type of form Form 5
Pack size and Demand Price 30’s; As per SRO
Approval status of product in Reference Symbicort Turbohaler
Regulatory Authorities 400micrograms/12micrograms/inhalation,
inhalation powder (MHRA approved)
Me-too-status Formiget DPI Capsule 400mcg+12mcg by Getz
Pharma (Reg#098828)
GMP Status The firm was inspected on 17-01-2019 and conlusion of
inspection was:
Grant of Section/ Facility and Regularization.
Remarks Response by the firm
 As per 290th decision of Registration The firm submitted approved layout plan
board, provide evidence of separate for manufacturing of DPI but have no
manufacturing facility/section for approved section/manufacturing facility at
manufacturing of DPIs including present.
specialized mixing facility to ensure the Moreover the firm submitted a list of
required particle size of the formulation equipments that will be used in
blend. manufacturing including eqipments for
DPI mixing, DPI filling, capsule polishing,
blistering and packaging. (No evidence of
availability)
 As per 290th decision of Registration The firm submitted list of equipments for
board, provide evidence of equipments performing the test of “Uniformity of
for performing the test of “Uniformity of Delivered Dose” and “Aerodynamic
Delivered Dose” and “Aerodynamic Particle Size Distribution” (No evidence
Particle Size Distribution” as per of availability)
Pharmacopoeia.
 The reference formulation have The firm have revised the label claim
mentioned the hydrated form (dihydrate) mentioning the hydrated form of
of Formoterol fumarate in the label Formoterol fumarate in the label claim
claim while you have not mentioned the
hydrated form. Revise the label claim as
per reference formulation mentioning
the hydrated form along with
submission of applicable fee.
 Submission of stability studies data of The firm have submitted commitment for
three batches as per Requirements of performing the stability study as per
Registration Board decision of 293rd Requirements of Registration Board
meeting. decision of 293rd meeting.
Decision: Deferred for confirmation of required manufacturing facility “Dry Powder inhaler”
section with manufacturing and testing equiments for applied formulation.
400. Name and address of manufacture / M/s Werrick Pahrmaceuticals.
Applicant 216-217,I-10/3, Industrial Area, Islamabad
Brand Name + Dosage Form and Remet 50mg Tablet
Strength
Vildagliptin………50mg
Dairy No. date of R &I fee Form-5 Dy.No 8797 dated 27-02-2019 Rs.20,000/- Dated
26-02-2019
Type of form Form 5
Finished product specifications In-house
Pack size and Demand Price 10’s, 14’s, 28’s; As per SRO
Approval status of product in Reference GALVUS vildagliptin 50mg tablets TGA Approved

Me-too-status Gevo 50mg Tablets by M/s BJ Pharmaceuticals,
(Reg#82780)
GMP Status The firm was inspected on 17-01-2019 and conlusion of
inspection was:
Grant of Section/ Facility and Regularization.
 The firm submitted revised label claim and master
formulation along with submission of Rs 20000/- on
deposit slip No. 2029286 dated 09.06.2020. The correct
label claim is as under:
Decision: Approved with innovator’s specifications and following label claim:
401. Name and address of manufacture / M/s Wilson's Pharmaceuticals.
Applicant 387-388, I-9, Industrial Area, Islamabad
Brand Name + Dosage Form and Wilsonide Plus Dry Powder Inhaler 400/12 mcg capsule
Strength
Composition Each DPI Capsule Contains:
Budesonide….…400mcg
Formoterol fumarate dihydrate…….12mcg
19-02-2019
Pharmacological Group Glucocorticosteroid/Selective β2 adrenoceptor
agonist
Type of form Form 5
Approval status of product in Reference Symbicort Turbohaler
Regulatory Authorities 400micrograms/12micrograms/inhalation,
inhalation powder (MHRA approved)
Me-too-status Formiget DPI Capsule 400mcg+12mcg by Getz Pharma
(Reg#098828)
inspection was:
“Overall the firm was found to be operating at a very good
level of CGMP Compliance at the time of inspection.”
XI
Remark of the Evaluator
Remarks Response by the firm
 As per 290th decision of Registration board, The firm submitted approved layout plan for
provide evidence of separate manufacturing manufacturing of DPI and panel constituted
facility/section for manufacturing of DPIs letter for onsite inspection but have no
including specialized mixing facility to ensure approved section/manufacturing facility at
the required particle size of the formulation present.
blend. Moreover the firm submitted a list of
equipments that will be used in manufacturing
including eqipments for DPI mixing and DPI
filling.
 As per 290 decision of Registration board, The firm informed that equipments for
th
provide evidence of equipments for performing the test of “Uniformity of

performing the test of “Uniformity of Delivered Dose” and “Aerodynamic Particle
Delivered Dose” and “Aerodynamic Particle Size Distribution” have been procured and are
Size Distribution” as per Pharmacopoeia. available for testing.

 The reference formulation have mentioned the The firm have revised the label claim
hydrated form (dihydrate) of Formoterol mentioning the hydrated form of Formoterol
fumarate in the label claim while you have not fumarate in the label claim
mentioned the hydrated form. Revise the label
claim as per reference formulation mentioning
the hydrated form along with submission of
applicable fee.
 Submission of stability studies data of three The firm have submitted commitment for
batches as per Requirements of Registration performing the stability study as per
Board decision of 293rd meeting. Requirements of Registration Board decision
of 293rd meeting.
Decision: Deferred for confirmation of required manufacturing facility “Dry Powder inhaler”
section with manufacturing and testing equiments for applied formulation.
402. Name and address of manufacture / M/s Pacific Pharmaceuticals Limited.
Applicant 30 km, Multan Road, Lahore, Pakistan
Brand Name + Dosage Form and Ledisuvir Tablets 400mg/90mg
Strength
Sofosbuvir…..…400mg
Ledipasvir………....90mg
Dairy No. date of R &I fee Form-5D Dy.No 8813 dated 27-02-2019 Rs.20,000/-
Dated 27-02-2019
Type of form Form 5-D
Finished product specifications Manufacturer ‘s Specifications
Approval status =of product in Harvoni 90mg/400mg film coated tablets, US-FDA
Reference Regulatory Authorities Approved
Me-too-status Sofopas 90mg/400mg Tablet by M/s Genix Pharma
(Reg#82274)
GMP Status The firm was inspected on 22/02/2018 and
Recommendations of inspections was:
In the light of the inspection conducted by the panel and
based on the people met, documents reviewed and findings
during inspection, M/s pacific pharma ltd Multan road
Lahore, was considered to be operating at good level of GMP
compliance at the time of inspection.
Therefore, the panel of inspectors recommends considering
the firm for grant of GMP certificate for export purposes.
“GMP Certificate Issued on 05-03-2018.”
 You have applied on form 5-D. Please apply on correct
form
 Submission of stability studies data of three batches as per
Requirements of Registration Board decision of 293rd
meeting.
403. Name and address of manufacture / M/s PDH Laboratories Pvt Ltd.
Applicant 9.5 km, Sheikhupura Road, Lahore, Pakistan
Brand Name + Dosage Form and Artinium Injection 80mg/ml I/M
Strength
Artemether ……80mg
25-02-2019
Pharmacological Group Anti- malarial
Type of form Form 5
Finished product specifications IP
Pack size and Demand Price 1mlx6’s; As per SRO
Approval status of product in Reference Artemether solution for injection 80mg/ml WHO Approved
Regulatory Authorities formulation
Me-too-status Artegen 80mg Injection of M/s Fassgen Pharma
(Reg#56462)
GMP Status Last inspection was conducted on 10-02-2020 and
conclusion of inspection was:
Base on the findings of the inspection, it is concluded that
most of the shortcomings of the previoud inspection had
been rectified. As the GMP is a continuous process, firm was
advised to make further improvements in their systems.
Based upon the visit of the facility, documents reviewed and
people met, the firm was found to be operating at a
satisfactory level of cGMP compliance at the time of
inspection.
Remark of the Evaluator XI  The firm revised the 1st page of form 5 as per approved
format.
 The manufacturer have claimed IP specifications while
official monograph is not available in any pharmacopeia
(USP, BP, IP, JP).
 The firm has provided liquid ampoule section confirmed
from GMP certificate.
Decision: Approved.
Brand Name + Dosage Form and Tazolin Injection 2.25gm
Strength
Piperacillin sodium eq to Piperacillin…..2gm
Tazobactam sodium eq to tazobactam…..0.25gm
20-02-2019
Pharmacological Group Penicillin and beta-lactamase inhibitor
Type of form Form 5
Pack size and Demand Price 1’s with WFI; As per SRO
Approval status of product in Reference ZOSYN (piperacillin and tazobactam) for injection, for
Regulatory Authorities intravenous use. USFDA approved
Me-too-status Tanzo Injection by M/s Bosch Pharmaceutical (Reg. No.
39593)
inspection.
 The firm submitted that lyophilized powder for injection
was written on the label by mistake and submitted the
revised the label accordingly.
Decision: Deferred for confirmation of required manufacturing facility “Dry Powder injectable
(Penicillin)” section for applied formulation.

Brand Name + Dosage Form and Tazolin Injection 4.5gm
Strength
Piperacillin sodium eq to Piperacillin…..4gm
Tazobactam sodium eq to tazobactam…..0.5gm
20-02-2019
Type of form Form 5
Pack size and Demand Price 1’s with WFI; As per SRO
Approval status of product in Reference ZOSYN (piperacillin and tazobactam) for injection, for
Regulatory Authorities intravenous use. USFDA approved
Me-too-status Tacip 4.5gm Injection by M/s Macter Int. (Reg#73632)
inspection.
Remark of the Evaluator XI  The firm submitted that lyophilized powder for injection
was written on the label by mistake and submitted the
revised the label accordingly.
Brand Name + Dosage Form and Augmoxin Injection 1.2gm
Strength
Amoxicillin sodium eq to Amoxicillin…1000mg
Potassium Clavulanate eq to Clavulanic Acid…200mg
20-02-2019
Pharmacological Group Combinations of penicillins, incl. beta-lactamase inhibitors
Type of form Form 5
Approval status of product in Reference Augmentin Intravenous (1000 mg/200 mg powder for
Regulatory Authorities solution for injection/infusion) MHRA Approved
Me-too-status Stamentin Dry Powder Injection 1.2gm by M/s Stallion
Pharmaceuticals (Reg. No. 77234)

inspection.
Brand Name + Dosage Form and Augmoxin Injection 600mg
Strength
Amoxicillin sodium eq to Amoxicillin……500mg
Potassium Clavulanate eq to Clavulanic Acid…..100mg
20-02-2019
Type of form Form 5
Approval status of product in Reference Augmentin Intravenous (500 mg/100 mg powder for
Regulatory Authorities solution for injection/infusion) MHRA Approved
Me-too-status Stamentin Dry Powder Injection 600mg by M/s Stallion
inspection.

Brand Name + Dosage Form and Floxin Injection 250mg
Strength
Flucloxacillin as Sodium..…250mg
25-02-2019
Pharmacological Group Beta-lactamase resistant penicillins
Type of form Form 5
Approval status of product in Reference Flucloxacillin 250 mg, powder for solution for injection
Regulatory Authorities MHRA Approved
Me-too-status Fluclox 500mg Dry Powder Injection by M/s Stallion

inspection.
Brand Name + Dosage Form and Floxin Injection 500mg
Strength
Flucloxacillin as Sodium……500mg
25-02-2019
Pharmacological Group Beta-lactamase resistant penicillins
Type of form Form 5
Approval status of product in Reference Flucloxacillin 500mg, powder for solution for injection
Me-too-status Fluclox 500mg Dry Powder Injection by M/s Stallion
inspection.
Brand Name + Dosage Form and Proket Injection 250mg/5ml
Strength
Ketamine as HCl…..50mg
25-02-2019
Pharmacological Group General anaesthetic
Type of form Form 5
Pack size and Demand Price 5mlx5ampoules; As per SRO
Approval status of product in Reference KETAMINE INTERPHARMA ketamine (as
Regulatory Authorities hydrochloride) 250mg/5mL solution for injection ampoule
TGA Approved
Me-too-status Ketwim 250mg/5ml Injection by M/s Wimits
Pharmaceuticals (Reg# 085112)

inspection.
 The firm revised the 1st page of form 5 as per approved
format.
 The firm submitted that they have applied for single
volume 5ml and 2ml was typographic error.
 The firm submitted another evidence of applied
formulation in TGA Austrailia in the same volume and
packed in ampoule. The firm revised the label claim as:
Each 5ml ampoule contains:
Ketamine HCl eq. to ketamine base……..250mg
Decision: Deferred for submission of fee for revision of label claim of applied formulation.
Brand Name + Dosage Form and Phenra-Vil Injection 45.5mg/2ml
Strength
Pheniramine Maleate..…45.5mg
20-02-2019
Pharmacological Group Anti-Histamine
Type of form Form 5
Pack size and Demand Price 2mlx50’s; 2mlx100’s; As per SRO
Me-too-status Zafvil Injection of Zafa Pharmaceuticals (Reg#030637)
most of the shortcomings of the previous inspection had been
rectified. As the GMP is a continuous process, firm was
inspection.
 Provide evidence of applied formulation/drug already
Brand Name + Dosage Form and Dolnot Plus Injection
Strength
Diclofenac sodium……75mg
Lidocaine HCl……..20mg
25-02-2019
Pharmacological Group NSAID/ Local anaesthetic
Type of form Form 5

Pack size and Demand Price 2mlx10 ampoule; As per SRO
Approval status of product in Reference Diclofenac-Mepha 75 ampoules for injection of (Swiss
Regulatory Authorities medics approved)
Me-too-status Aram Plus Injections of M/s Bosch Pharmaceuticals
(Reg#048488)
most of the shortcomings of the previous inspection had been
rectified. As the GMP is a continuous process, firm was
inspection.

413. Name and address of manufacture / M/s Kaizen Pharmaceuticals Pvt Ltd.
Applicant E-127-129, North Western Industrial Zone, Bin Qasim,
Karachi
Brand Name + Dosage Form and Revosirox Tablet 400mg
Strength
Composition Each dispersible tablet contains:
Deferasirox..…400mg
25-02-2019
Pharmacological Group Iron chelating agent
Type of form Form 5
Finished product specifications Innovator’s specifications
Approval status of product in Reference Asunra Orodispersible tablets 400mg Novartis
Regulatory Authorities (Bangladesh) Ltd
Me-too-status Dasirox Tablet 400mg by M/s CCL Phamaceuticals
(Reg#68113)
inspection was:
The building, facilities and procedures demonstrated at the
time of inspection found at satisfactory level of GMP
compliance. Moreover, firm should focus on above
mentioned observations and comply with them on priority
basis.
format duly signed by the signatory
 The firm provided evidence of approval of applied
formulation not in reference regulatory authorities /
agencies which could not be verified
authorities/agencies which were adopted by the Registration Board in its 275th meeting
Karachi
Brand Name + Dosage Form and Revosirox Tablet 100mg
Strength
Composition Each dispersible tablet contains:
Deferasirox……100mg

25-02-2019
Pharmacological Group Iron chelating agent
Type of form Form 5
Approval status of product in Reference Asunra Orodispersible tablets 100mg Novartis
Regulatory Authorities (Bangladesh) Ltd
Me-too-status Dasirox Tablet 100mg by M/s CCL Phamaceuticals
(Reg#68112)
inspection was:
basis.
 The firm provided evidence of approval of applied
formulation not in reference regulatory authorities /
agencies and which could not be verified
authorities/agencies which were adopted by the Registration Board in its 275th meeting
Karachi
Brand Name + Dosage Form and Evergraf 0.5mg Tablet
Strength
Everolimus…..0.5mg
19-02-2019
Pharmacological Group Selective Immuno- suppressant
Type of form Form 5
Approval status of product in Reference ZORTRESS (0.25 mg, 0.5 mg, 0.75 mg) (uncoated) tablets
Me-too-status Everglo 0.5mg tablet by M/s Global Pharmaceuticals
(Reg#096504)
inspection was:
basis.
format duly signed by the signatory.
 The firm revised the label claim from film coated tablet to
uncoated tablet along with submission of Rs. 5000/- on
deposite slip No, 0805589 date 15.06.2020. The revised
Everolimus…..0.5mg
Moreover the firm submitted revised master formulation.

Decision: Registration Board deliberated the matter and decided to defer the case for confirmation
of cytotoxic facility since the applied formulation falls in both L01 and L04 categories as per WHO
ATC classification.
Karachi
Brand Name + Dosage Form and Servigraf gastro-resistant Tablet 180mg
Strength
Composition Each gastro-resistant tablet contains:
Mycophenolic Acid....…180mg
21-02-2019
Type of form Form 5
Approval status of product in Reference Mycophenolic acid 180mg gastro-resistant tablets (MHRA
Me-too-status Myfortic 180mg Gastro-Resistant Tablet by M/s Novartis
Pharma (Reg# 033172)
inspection was:
basis.
 The firm have mentioned the salt form in label claim along
with submission of Rs. 5000/- on deposite slip No.
0805590 date 15.06.2020. The revised label claim is as
under:
Each enteric coated tablet contains:
Mycophenolate sodium equivalent to Mycophenolic
Acid…..…180mg
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs
Karachi
Brand Name + Dosage Form and Servigraf gastro-resistant Tablet 360mg
Strength
Composition Each gastro-resistant tablet contains:
Mycophenolic Acid..…360mg
21-02-2019
Type of form Form 5
Approval status of product in Reference Mycophenolic acid 360mg gastro-resistant tablets (MHRA
Me-too-status Myfortic 360mg Gastro-Resistant Tablet by M/s Novartis
Pharma (Reg# 033173)

inspection was:
basis.
 The firm have mentioned the salt form in label claim along
with submission of Rs. 5000/- on deposite slip No.
0805591 date 15.06.2020. The revised label claim is as
under:
Mycophenolate sodium equivalent to Mycophenolic
Acid…..…360mg
personnel which remain in direct contact or are involved in close handling of these drugs
418. Name and address of manufacture / M/s MTI Medical Pvt Ltd.
Applicant 586-587, Sundar Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Tramol 50mg Capsule
Strength
Tramadol HCl……50mg
22-02-2019
Type of form Form 5
Approval status of product in Reference Tramadol Hydrochloride Capsules 50mg MHRA Approved
Me-too-status Palmadol Capsule 50 mg by M/s Palpex Pharmaceuticals
(Reg #82942 )
GMP Status GMP certificate issued to MTI Medical based on inspection
dated 17.07.2018
 The firm submitted revised form 5 as per approved
format.
Decision: Approved.
Brand Name + Dosage Form and Meberin 200mg Capsule
Strength
Composition Each modified release Capsule Contains:
Mebeverine HCl (SR pellets 50%)...…200mg
22-02-2019
Pharmacological Group Anticholinergic
Type of form Form 5
Approval status of product in Reference Colofac MR Modified release capsule (MHRA Approved)
Me-too-status Mebever MR 200mg Capsule of M/s Getz Pharma
(Reg.#050747)

dated 17.07.2018
Remark of the Evaluator XI  The firm submitted revised form 5 as per approved
format.
 The firm provided source of pellets (Vision Pharma),
certificate of analysis of pellets, stability studies data of
three batches and GMP certificate of supplier of pellets
Brand Name + Dosage Form and Diclomed 100mg SR Capsule
Strength
Diclofenac sodium (as sustained release pellets 32%)
….…100mg
22-02-2019
Type of form Form 5
Approval status of product in Reference Diclomax Retard 100mg capsule MHRA Approved
Me-too-status Dicloyan-S 100mg capsule Roryan Pharmaceutical
(Reg.#68337)
dated 17.07.2018
Remark of the Evaluator XI  The firm submitted revised form 5 as per approved
format.
 The firm provided source of pellets (Vision Pharma),
certificate of analysis of pellets, stability studies data of
three batches and GMP certificate of supplier of pellets
Decision: Approved.
421. Name and address of manufacture / M/s Zafa Pharmaceuticals Laboratories Private Limited. L-
Applicant 4/1, A&B Block-21, Federal B industrial Area, Karachi
Brand Name + Dosage Form and Irozaf FA Chewable tablet 100mg/0.35mg
Strength
Composition Each chewable tablet contains:
Iron as Iron (III) Hydroxide Polymaltose
complex…..…100mg
Folic Acid………0.35mg
01-02-2019
Pharmacological Group Iron in combination with folic acid
Type of form Form 5
Approval status of product in Reference Ferrum Fol 100mg/350microgram chewable tablet France
Regulatory Authorities Approved… as provided by the firm could not be verified
Me-too-status Inofer-F Chewable Tablet by Kaizen Pharmaceuticals
(Reg#81171)
GMP Status “GMP certificate Issued on 15-5-2018 based on inspection
conducted on 11-1-2018.”
format along with undertaking at the end of form 5 signed
by the technical persons

regulatory authorities/agencies which were adopted by
the Registration Board in its 275th meeting could not be
verified
Decision: Approved with innovator’s specification, since iron preparations are not considered as
drug by various reference regulatory authorities.
Brand Name + Dosage Form and Irozaf Chewable tablet 100mg
Strength
Iron as Iron (III) Hydroxide Polymaltose
complex…...100mg
01-02-2019
Pharmacological Group Anti-anemic preparations
Type of form Form 5
Approval status of product in Reference Ferrum Hausmann100mg chewable tablet France
Regulatory Authorities Approved… as provided by the firm could not be verified
Me-too-status Rubifer-F Chewable Tablets by M/s Ali Gohar
Remark of the Evaluator XI  The firm revise the 1st page of form 5 as per approved
format.
the Registration Board in its 275th meeting could not be
verified
Decision: Approved with innovator’s specification, since iron preparations are not considered as
drug by various reference regulatory authorities.
Brand Name + Dosage Form and Irozaf Drops 50mg/ml
Strength
Iron as Iron (III) Hydroxide Polymaltose complex…..50mg
28-01-2019
Pharmacological Group Anti-anemic preparations
Type of form Form 5
Approval status of product in Reference MALTOFER Drops 50mg/mL TGA Approved
Me-too-status Feritose Drops by M/s Libra Pharmaceuticals (Reg#77452)
format.
424. Name and address of manufacture / M/s Wilshire Laboratories Pvt Ltd.
Applicant 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
Brand Name + Dosage Form and Vomidox Tablet 10mg/10mg
Strength
Doxylamine succinate………10mg
Pyridoxine…..10mg
06-02-2019
Type of form Form 5
Pack size and Demand Price 5’s, 7’s, 10’s, 20’s, 30’s, 40’s, 50’s; As per SRO
Approval status of product in Reference DICLEGIS (doxylamine succinate/pyridoxine
Regulatory Authorities hydrochloride 10/10mg) film coated delayed release tablet
USFDA approved
Me-too-status Omit 10/10mg Tablet by M/s Scilife Pharma,
(Reg#082087)
GMP Status The firm was inspected on 27-08-2018, 05-10-2018, 06-11-
2018 and Recommendations of inspections were:
The firm Wilshire Labs Lahore evaluated with respect to
productions operations, personal, documentations, Quality
assurance and quality control etc. Based on observations the
firm was found to be operating at satisfactory level of GMP
compliance at the time of inspections.
Remark of the Evaluator XI  The firm submitted revised Form 5 and corrected the salt
form pyridoxine hydrochloride instead of pyridoxine in
the label claim without submission of fee. The firm futher
stated that mentioning pyridoxine instead of pyridoxine
hydrochloride was a typographical mistake and that they
have applied pyridoxine hydrochloride in master
formulation
Decision: Deferred for submission of applicable fee for revision of formulation.
425. Name and address of manufacture / M/s Maxitech Pharma Pvt Ltd.
Applicant Plot No. E-178, S.I.T.E. Super Highway, Phase II, Karachi
Brand Name + Dosage Form and Glifloz-M 5mg/500mg film coated Tablet
Strength
Empagliflozin ……5mg
Metformin HCl……500mg
11-02-2019
Type of form Manufacturer’s specifications
Finished product specifications 14’s; As per SRO
Approval status of product in Reference SYNJARDY (5mg/500mg, 5mg/1000mg, 12.5 mg/500 mg,
Regulatory Authorities 12.5mg/1000 mg) film coated tablets USFDA Approved
Me-too-status
inspection was:
Based on above observations and keeping in view the
attitude of the management of the firm towards constant
improvement their current GMP compliance level is rated as
Good.
 The firm did not provide evidence of applied
formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name
and name of firm

 The firm informed that stability studies of the above
product is in process and data of three batches will be
submitted upon completion of the study.
Submission of application on form-5D alongwith differential fee.
submission of stability study data as per guidelines provided in 293rd meeting of Registration
Board.
426. Name and address of manufacture / "M/s Inventor Pharma.
Applicant Plot No. K/196, S.I.T.E. (SHW) Phase II, Karachi"
Brand Name + Dosage Form and Inoset 50mg Tablet
Strength
Sertraline HCl…...…50mg
Dairy No. date of R &I fee Form-5 Dy.No 71 dated 01-01-2019 Rs.20,000/- Dated 31-
12-2018
Type of form Form 5
Approval status of product in Reference LUSTRAL 50mg film coated tablets MHRA Approved
Me-too-status Seralin 50mg Tablet by M/s Bosch Pharmaceuticals
(Reg#83323)
inspection was:
Keeping in view the stated conditions and attitude of the firm
towards better compliance, their current GMP is rated as
GOOD.
Remark of the Evaluator XI  The firm have revised the label claim as per reference
formulation not considering the salt factor along with
submission of Rs. 20,000/- on deposit slip No.2044519
dated 04-06-2020. The revised label claim is:
Each Film Coated Tablet Contains:
Sertraline HCl equivalent to Sertraline…….…50mg
Decision: Approved.
Brand Name + Dosage Form and Inopride 50mg Tablet
Strength
Itopride hydrochloride…...…50mg
Dairy No. date of R &I fee Dy. No 83 dated 01-01-2019, Rs.20,000/- Dated 31-12-2018
Type of form Form 5
Approval status of product in Reference Ganaton 50mg tablet (PMDA) Japan Approved
Me-too-status Xepride tablet 50mg of M/s Usawa Pharmaceuticals (Reg.
# 076818)
inspection was:
GOOD.
Remark of the Evaluator XI  The firm revised the weight of API in master formulation
as per reference formulation along with submission of Rs.
5000/- on deposit slip No. 2044517 dated 04-06-2020.
The weight of API mentioned in master formulation was
160mg/tab while weight of API in tab is 50mg/tab. The
firm was not asked for submission of fee.
 The manufacturer has claimed manufacturer’s
specifications while official monograph is not available
in any pharmacopeia (USP, BP, IP, JP).
Brand Name + Dosage Form and Moxiventor 400mg tablet
Strength
Moxifloxacin HCl….…...400mg
12-2018
Pharmacological Group Quinolone antibiotic
Type of form Form 5
Approval status of product in Reference AVELOX 400mg tablets, film-coated. USFDA approved
Me-too-status Moxizyan 400mg Tablets, film-coated by
Genesis Pharmaceuticals (Reg# 77252)
inspection was:
GOOD.
Remark of the Evaluator XI  The firm have revised the label claim as per reference
formulation not considering the salt factor along with
submission of Rs. 5000/- on deposite slip No.2044521
dated 04-06-2020. The revised label claim is:
Moxifloxacin as HCl…...…400mg
 The manufacturer have claimed innovator’s
specifications while official monograph available in USP.
Brand Name + Dosage Form and Innocid 500mg/5ml Injection
Strength
Tranexamic Acid…..500mg
12-2018
Type of form Form 5
Approval status of product in Reference TRANEXAMIC ACID 500mg/5 mL solution for injection
Regulatory Authorities ampoule TGA approved
Me-too-status Tremic -500 Injection by M/s Fynk Pharmaceuticals
(Reg#62678)
inspection was:

GOOD.
Remark of the Evaluator XI  The firm submitted revised master formulation along with
submission of Rs. 5000/- on deposit slip No.2044520 date
04-06-2020 but did not address the following short
comings.
 You have applied for tranexamic acid injection but in
master formulation tranexamic acid hydrochloride is
mentioned, clarify?
 Furthermore, master formulation is not as per reference
formulation justify (Having no pH adjusting agents
hydrochloric acid, sodium hydroxide)?
Decision: Deferred for revision of formulation as per reference product.
430. Name and address of manufacture / M/s Hiranis Pharmaceuticals Pvt Ltd.
Applicant Plot No. E-145 to E-149, North Western Industrial Zone,
Port Qasim, Karachi, Pakistan
Brand Name + Dosage Form and Irazem tablet 20mg
Strength
Aripiprazole………20mg
01-03-2019
Pharmacological Group Other antipsychotics
Type of form Form-5
Approval status of product in Reference Abilify (2mg, 5mg, 10mg, 15mg, 20mg, 30mg) Tablets
Me-too-status Apify 20mg Tablet by M/s Akhai Pharma (Reg#76248)
GMP Status The firm was inspected on 29-01-2019 and was overall GMP
compliant
format
Decision: Approved.
Strength
Aripiprazole…….…10mg
01-03-2019
Type of form Form-5
compliant
Decision: Approved.

Strength
Aripiprazole………15mg
01-03-2019
Type of form Form-5
compliant
Decision: Approved.
Strength
Aripiprazole…………30mg
Dairy No. date of R &I fee Form-5 Dy.No 10822dated 05-03-2019 Rs.20,000/- Dated
01-03-2019
Type of form Form-5
compliant
format
Decision: Approved.
Brand Name + Dosage Form and Imuprine Tablet 50mg
Strength
Azathioprine…….50mg
01-03-2019
Pharmacological Group Other immunosuppressants
Type of form Form-5
Approval status of product in Reference Azafalk 50mg film-coated tablets (MHRA Approved)
Me-too-status Azoprine Tablets by M/s Global Pharmaceuticals
(Reg#25196)
compliant
Remark of the Evaluator XI  The firm have revised the label claim from uncoated to
film coated tablet along with submission of Rs 5000/- on
deposite slip No. 2048060 dated 23-07-2020. The firm
also revised the master formulation and manufacturing
method. The revise label claim is:
Each film coated Tablet Contains:
Azathioprine…….50mg
format
personnel which remain in direct contact or are involved in close handling of these drugs.
Brand Name + Dosage Form and Mygaba Capsule 100mg
Strength
Gabapentin………..100mg
26-02-2019
Type of form Form-5
Approval status of product in Reference Gabapentin 100mg capsule (MHRA Approved)
Me-too-status Gabateric 100 mg Capsule by M/s High-Q Pharmaceutical
(Reg#47245)
compliant
format
Decision: Approved.
Strength
Gabapentin…..…300mg
26-02-2019
Type of form Form-5
(Reg#47341)
compliant
format
Decision: Approved.
Strength
Gabapentin……….400mg
26-02-2019
Type of form Form-5
(Reg#47246)
compliant
format
Decision: Approved.
Brand Name + Dosage Form and Hirafen Tablet 400mg
Strength
Ibuprofen……..400mg
01-03-2019
Type of form Form-5
Approval status of product in Reference Brufen 400mg film coated tablet (MHRA approved)
Me-too-status Medibrufen 400mg tablet by M/s Mediate Pharma
(Reg#61940) (does not depict coating)
compliant
format
Decision: Approved.
Strength
Ibuprofen…………..200mg
01-03-2019
Type of form Form-5
Approval status of product in Reference Brufen 200mg film coated tablets (MHRA Approved)
Me-too-status Medibrufen 200mg tablet by M/s Mediate Pharma
(Reg#61941) (does not depict coating)
compliant
format
Decision: Approved.
Brand Name + Dosage Form and Hirafen Suspension 100mg/5ml
Strength
Ibuprofen………100mg
01-03-2019
Type of form Form-5
Approval status of product in Reference Brufen 100mg/5ml Suspension (MHRA Approved)
Me-too-status Nuprin 100mg Suspension by M/s Reign Pharma
(Reg#76477)
compliant
format
Decision: Approved.
Strength
Ibuprofen…………..600mg
01-03-2019
Type of form Form-5
Approval status of product in Reference Brufen 600mg film coated tablets (MHRA approved)
Me-too-status Fenbru 600mg Tablets by M/s Platinum pharma
(Reg#42105)
compliant
format
Decision: Approved.

Brand Name + Dosage Form and Sykopride Tablet 50mg
Strength
Levosulpiride………50mg
26-02-2019
Type of form Form-5
Approval status of product in Reference Levosulpiride Aristo 50mg tablets AIFA Italy Approved.
Me-too-status Sulvoric 50mg Tablet by M/s High-Q (Reg#070485)
compliant
format
Strength
Levosulpiride…….…25mg
26-02-2019
Type of form Form-5
Approval status of product in Reference Levosulpiride Aristo 25 mg tablets, AIFA Italy approved.
compliant
format
Strength
Levosulpiride…..…100mg
26-02-2019
Type of form Form-5
Approval status of product in Reference Levosulpiride Aristo 100mg tablets, AIFA Italy approved.
compliant
format
Brand Name + Dosage Form and Melican Tablet 15mg
Strength
Meloxicam…….…15mg
26-02-2019
Pharmacological Group Non-steroidal anti-inflammatory drugs (NSAIDs)
Type of form Form-5
Approval status of product in Reference MOBIC (7.5mg, 15mg) uncoated Tablets USFDA
Me-too-status Melflam 15mg Tablets by M/s Aries Pharmaceuticals
(Reg#84266)
compliant
format
Decision: Approved.
Brand Name + Dosage Form and Melican Tablet 7.5mg
Strength
Meloxicam…………7.5mg
26-02-2019
Type of form Form-5
Approval status of product in Reference MOBIC (7.5mg, 15mg) uncoated Tablets USFDA
Me-too-status Melflam 7.5mg Tablets by M/s Aries Pharmaceuticals
(Reg#84265)
compliant
format
Decision: Approved.
Brand Name + Dosage Form and Mexate Tablet 10mg
Strength
Methotrexate………..10mg
26-02-2019
WHO ATC code: L04AX03
Type of form Form-5
Approval status of product in Reference Methotrexate 10mg tablets MHRA Approved
Me-too-status Methotrexate tablet 10mg of M/s Pak China International
(Reg# 066009)
compliant
format
Decision: Registration Board deliberated the matter and decided to defer the case for confirmation
of cytotoxic facility since the applied formulation falls in both L01 and L04 categories as per WHO
ATC classification.
Brand Name + Dosage Form and Mexate Tablet 2.5mg
Strength
Methotrexate……….2.5mg
26-02-2019
Type of form Form-5
Approval status of product in Reference Methotrexate 2.5mg Tablets MHRA Approved
Me-too-status Methotrexate 2.5mg by PAK CHINA INTERNATIONAL
(Reg #066007)
compliant
format
Decision: Decision: Registration Board deliberated the matter and decided to defer the case for
confirmation of cytotoxic facility since the applied formulation falls in both L01 and L04
categories as per WHO ATC classification.
Brand Name + Dosage Form and Gylica Capsule 300mg
Strength
Pregabalin……….300mg
26-02-2019
Type of form Form-5
Approval status of product in Reference LYRICA (25mg, 50mg, 75mg, 100mg, 150mg, 200mg,
Regulatory Authorities 225mg, 300mg) Capsules, USFDA Approved
Me-too-status Gabica 300mg Capsules by M/s Getz Pharma (Reg#47368)
compliant
format
Strength
Pregabalin……..…200mg
26-02-2019
Type of form Form-5
compliant
format
Strength
Pregabalin………..100mg
26-02-2019
Type of form Form-5
compliant
Strength
Pregabalin…………150mg
26-02-2019
Type of form Form-5
compliant
format
Strength
Pregabalin……….…50mg
26-02-2019
Type of form Form-5
compliant
format
Strength
Pregabalin…………75mg
26-02-2019
Type of form Form-5
compliant
Brand Name + Dosage Form and Ultradol Tablet 50mg
Strength
Tramadol HCl……….…50mg
01-03-2019
Pharmacological Group Opioid analgesic
Type of form Form-5
Approval status of product in Reference ULTRAM (50mg) film tablets, USFDA Approved.
Me-too-status Allay 50mg Tablet by M/s Tabros Pharma (Reg#74963)
compliant
format alongwith undertaking at the end of form 5 signed
Decision: Approved.
Brand Name + Dosage Form and Alavert-D Tablet 5/120mg
Strength
Composition Each film coated extended-release tablet contains:
Loratadine ………………….......5mg
Pseudoephedrine Sulfate .…....120mg
01-03-2019
Pharmacological Group Sympathomimetics (Nasal Decongestants)
Type of form Form-5
Approval status of product in Reference Claritin-D (5mg;120mg) Extended Release tablets USFDA
Me-too-status Softin- P tablet of M/s Werrick Pharma (Reg. # 060094)
Could not be confirmed as extended- release tablet
compliant
Remark of the Evaluator XI  The firm revised the 1st page of form 5 as per prescribed
format but submitted without applicant signature.
 The firm submitted revised form 5 and revised the label
claim from bilayered tablet to film coated extended
release tablet along with submission of Rs. 5000/- on
deposit slip No. 2048070 dated 29.07.2020. The also
submitted revised master formulation and manufacturing
outline.
 However, the reference formulation contains contains 5
mg loratadine in the tablet coating (immediate release)
and 120mg pseudoephedrine sulfate equally distributed
between the tablet coating (immediate release) and the
barrier-coated core (extended release). The two active
components in the coating are quickly liberated; release
of the decongestant in the core is delayed for several
hours.
 The manufacturing method of the applied product is not
as per reference formulation
Decision: Deferred for submission of manufacturing outline as per reference formulation.
Brand Name + Dosage Form and Ultradol SR Tablet 100mg
Strength
Composition Each film coated sustained release Tablet Contains:
Tramadol HCl………….100mg
01-03-2019
Type of form Form-5
Approval status of product in Reference Brimisol PR 100mg prolonged release tablets MHRA
Me-too-status Zultra SR 100mg tablet by M/s Wilshire Laboratories
(Reg#80713)
compliant
Remark of the Evaluator XI  The firm did not revised the 1st page of form 5 as per
prescribed format and also submitted without applicant
signature.
 The firm submitted revised form 5 and revised the label
claim from immediate release tablet to film coated
sustained release tablet along with submission of Rs.
5000/- on deposit slip No. 2048069 dated 29.07.2020.
The also submitted revised master formulation and
manufacturing outline.
Decision: Deferred for submission of differential fee of Rs. 15,000 for revision of formulation.
458. Name and address of manufacture / M/s Lisko Pakistan Pvt Ltd.
Applicant L-10-D, Block 21, Shaheed Rashid Minhas Road, F.B.
Industrial Area, Karachi
Brand Name + Dosage Form and Telsart AM Tablet 10/40mg
Strength
Composition Each bilayered tablet contains:
Amlodipine Besylate eq to Amlodipine…10mg
Telmisartan…40mg
07-12-2018
Pharmacological Group Calcium channel blockers and Angiotensin II receptor
blockers (ARBs)
Type of form Form 5
Approval status of product in Reference TWYNSTA Tablets 10mg/40mg (USFDA Approved)
Me-too-status Amtas 10mg + 40mg Tablet of M/s Sami Pharmaceuticals
(Reg. # 066945)
GMP Status The firm was inspected on 24.04.2018, conclusion of
inspection was:
“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)”
Remark of the Evaluator XI  Evidence of availability of bilayered compression tablet
facility
 Master formulation is missing
Decision: Deferred for confirmation of installation and operational qualification of bilayered
compression machine by the area FID.
Strength
Amlodipine Besylate eq to Amlodipine…..5mg
Telmisartan……80mg
07-12-2018
blockers (ARBs)
Type of form Form 5
Me-too-status Telmipin 5mg + 80mg Tablet of M/s Schazoo Zaka (Reg. #
0090511)
inspection was:
of cGMP compliance.
Remark of the Evaluator XI  1st page of form 5 is missing. Submit complete form 5.
 Evidence of availability of bilayered compression tablet
facility
Strength
Telmisartan…..40mg
07-12-2018
blockers (ARBs)
Type of form Form 5
Me-too-status Telmipin 5mg + 40mg Tablet of M/s Schazoo Zaka (Reg. #
0090514)
inspection was:
of cGMP compliance.
Remark of the Evaluator XI  1st page of form 5 and undertaking is missing. Submit
complete form 5.
facility
Strength
Telmisartan…..80mg
07-12-2018
blockers (ARBs)
Type of form Form 5
Me-too-status Telmipin 10mg + 80mg Tablet of M/s Schazoo Zaka (Reg.
# 0090512)
inspection was:
of cGMP compliance.
Remark of the Evaluator XI  1st page of form 5 is missing. Submit complete form 5.
facility
462. Name and address of manufacture / M/s Akhai Pharmaceuticals Pvt Ltd.
Applicant Plot # A-248 & A-256 to A-259, H.I.T.E. Lasbela
Balochistan, Pakistan
Brand Name + Dosage Form and Treclin Gel 1%/0.025%
Strength
Clindamycin phospate eq to Clindamycin…….10mg
Tretinoin………….0.25mg
26-02-2019
Pharmacological Group Antibiotic, Retinoids
Type of form Form 5
Pack size and Demand Price 20gm; As per SRO
Approval status of product in Reference Treclin 1 % / 0.025 % (Clindamycin/Tretinoin) w/w gel
Regulatory Authorities (MHRA Approved)
Me-too-status
inspection was:
During the comprehensive visit and detail inspection almost
all respective documents from QA, QC, Production were
reviewed and retrieval of the same was noted good. Based
on the people met and documents reviewed overall GMP of
the firm rated as GOOD.
Remark of the Evaluator XI  The firm provide evidence of Acdermin Gel 1.2%w/w /
0.025%w/w by M/s Atco Laboratories (Reg#58435)
having different concentration of API from the applied
product.
 The firm revised the type of primary packaging container
from plastic laminated tube to aluminium tube with an
epoxyphenolic internal lacquer, fitted with a polyethylene
cap as per reference product
Brand Name + Dosage Form and Nicotab 10mg Tablet
Strength
Nicorandil……10mg
26-02-2019
Pharmacological Group Other vasodilators used in cardiac diseases
Type of form Form 5
Pack size and Demand Price 10’s; 20’s; 30’s; As per SRO
Approval status of product in Reference IKOREL Nicorandil 10mg tablet un-coated. TGA approved
Me-too-status Nicogina 10mg Tablet by M/s Macter International (Reg.
No. 67049)
inspection was:
Remark of the Evaluator XI  The firm have revised the label claim from film coated
tablet to uncoated tablet along with submission of Rs
5000/- on deposite slip No. 1996023 dated 27-07-2020.
The firm also revised the master formulation and
manufacturing method. The revise label claim is:
Each uncoated Tablet Contains:
Nicorandil …….10mg
Decision: Approved.
Brand Name + Dosage Form and Nicotab 20mg Tablet
Strength
Nicorandil……20mg
26-02-2019

Pharmacological Group Other vasodilators used in cardiac diseases
Type of form Form 5
Approval status of product in Reference IKOREL Nicorandil 20mg un-coated tablet. TGA approved
Me-too-status Nicogina 20mg Tablet by M/s Macter International (Reg.
No. 67050)
inspection was:
Remark of the Evaluator XI  The firm have revised the label claim from film coated
tablet to uncoated tablet along with submission of Rs
The firm also revised the master formulation and
manufacturing method. The revise label claim is:
Each uncoated Tablet Contains:
Nicorandil …….20mg
Decision: Approved.
Brand Name + Dosage Form and Olmetab-A 5/20mg Tablet
Strength
Amlodipine Besylate…5mg
Olmesartan Medoxomil…20mg
25-02-2019
Pharmacological Group Calcium channel blockers/Angiotensin II receptor blockers
(ARBs)
Type of form Form 5
Finished product specifications In house
Approval status of product in Reference Azor 5mg/20mg film coated tablets of (USFDA Approved)
Me-too-status Olesta AM 5/20mg of M/s Searle Pakistan (Reg#076187)
inspection was:
Remark of the Evaluator XI  The firm have submitted revised form 5 revising the label
claim from uncoated to film coated tablets and corrected
the salt form of amlodipine along with submission of Rs.
5000/- on deposite slip No. 1996019 dated 06.08.2020.
The correct label claim is:
Amlodipine Besylate eq. to Amlodipine……..5mg
Olmesartan Medoxomil………..…20mg

Strength
25-02-2019
(ARBs)
Type of form Form 5
Approval status of product in Reference Azor 5mg/40mg film coated tablets of (USFDA Approved)
Me-too-status Olesta AM 5/40mg of M/s Searle Pakistan (Reg#076188)
inspection was:
Amlodipine Besylate eq. to Amlodipine…….5mg
Olmesartan Medoxomil…………….40mg
Strength
25-02-2019
(ARBs)
Type of form Form 5
Approval status of product in Reference Azor 10mg/20mg film coated tablets of (USFDA
Me-too-status Olesta AM 10/20mg by M/s Searle Pakistan (Reg#076189)
inspection was:

Strength
25-02-2019
(ARBs)
Type of form Form 5
Approval status of product in Reference Azor 10mg/40mg film coated tablets of (USFDA
Me-too-status Olesta AM 10/40mg by M/s Searle Pakistan (Reg#076190)
inspection was:
469. Name and address of manufacture M/s Jaskon Pharmaceuticals Pvt Ltd
/ Applicant 5- Sundar Industrial Estate, Lahore
Brand Name + Dosage Form and Simzet 10/40mg Tablet
Strength
Ezetimibe…………10mg
Simvastatin………..40mg
03-2019
Pharmacological Group Lipid lowering agent/HMG-CoA reductase inhibitor
Type of form Form-5

Pack size and Demand Price 7’s, 10’s, 14’s, 50’s; As per SRO
Approval status of product in VYTORIN (ezetimibe and simvastatin) (10/10, 10/20, 10/40,
Reference Regulatory Authorities10/80) tablets USFDA Approved
Me-too-status Simbex tablet 10/40 by M/s Searle Pharma (Reg#44050)
GMP Status A panel inspection was conducted on 13.03.2018 and conclusion
of inspection was:
Keeping in view the compliance submitted by the firm and
inspection conducted by the panel, the resumption of production
to M/s Jakson Pharma Lahore is recommended
Remark of the Evaluator XI  The firm did not submit undertaking at the end of form 5.
 The firm submitted that they have applied for film coated tablet
as evident from annexure-F (description of specifications) and
master formulation (but reference formulation is uncoated).
 The chemistry review Vytorin of USFDA states that in solid
state, oxidation of simvastatin can occur, especially at elevated
temperature, therefore, butylated hydroxyanisole is added to
the drug substance.
Butylated hydroxyanisole NF, citric acid monohydrate USP, and
propyl gallate NF.
 Hence, based on the information extracted from Public
assessment report it is concluded that simvastatin losses to
thermal degradation in the presence of oxygen, antioxidants
shall be added in the formulation. These antioxidants shall also
be quantified by suitable test method.
The manufacturing of the applied formulation should also be as
per innovator that involves the following steps:
a) sifting of the main excipients
b) preparation of the drug dispersion
c) top spray granulation and drying
d) spraying of the antioxidants solution on the granules,
e) dry screening,
f) blending and lubrication
g) compression
Moreover, the shelf life accepted is 18 months if stored in
aluminum-aluminum blisters not above 25°C. As Zone IV A is
more severe condition the shelf life will be more stringent.
Brand Name + Dosage Form and Simzet 10/20mg Tablet
Strength
Ezetimibe……………10mg
Simvastatin…………..20mg
03-2019
Pharmacological Group Lipid lowering agent/HMG-CoA reductase inhibitor
Type of form Form-5
Approval status of product in VYTORIN (ezetimibe and simvastatin) (10/10, 10/20, 10/40,
Reference Regulatory Authorities 10/80) tablets USFDA Approved
Me-too-status Simbex tablet 10/20 of Searle Pharma (Reg#44049)
of inspection was:

master formulation (but reference formulation is uncoated).
 The chemistry review Vytorin of USFDA states that in solid
state, oxidation of simvastatin can occur, especially at elevated
temperature, therefore, butylated hydroxyanisole is added to
the drug substance.
Butylated hydroxyanisole NF, citric acid monohydrate USP, and
propyl gallate NF.
 Hence, based on the information extracted from Public
assessment report it is concluded that simvastatin losses to
thermal degradation in the presence of oxygen, antioxidants
shall be added in the formulation. These antioxidants shall also
be quantified by suitable test method.
The manufacturing of the applied formulation should also be as
per innovator that involves the following steps:
a) sifting of the main excipients
b) preparation of the drug dispersion
c) top spray granulation and drying
d) spraying of the antioxidants solution on the granules,
e) dry screening,
f) blending and lubrication
g) compression
Moreover, the shelf life accepted is 18 months if stored in
aluminum-aluminum blisters not above 25°C. As Zone IV A is
more severe condition the shelf life will be more stringent.
Brand Name + Dosage Form and Fabita 80mg Tablet
Strength
Febuxostat…………..80mg
03-2019
Pharmacological Group Antigout preparation
Type of form Form-5
Approval status of product in 2x10’s; ULORIC (40mg, 80mg) film coated tablets USFDA
Me-too-status Febuxin 80mg tablet by AGP Ltd (Reg. 081105)
of inspection was:
master formulation and did not revise label claim

Brand Name + Dosage Form and Jaspir 25mg Tablet
Strength
Levosulpiride…………25mg
03-2019
Type of form Form-5
Approval status of product in Levosulpiride Aristo 25 mg tablets, AIFA Italy approved.
of inspection was:
Decision: Deferred for submission of undertaking of Form-5.
Brand Name + Dosage Form and Jaset 8mg Tablet
Strength
Ondansetron (as hydrochloride dihydrate)…8mg
03-2019
Pharmacological Group Antiemetics and antinauseants (Serotonin (5HT3) antagonists)
Type of form Form-5
Approval status of product in ZOFRAN (4mg, 8mg) film coated tablets, USFDA Approved
Me-too-status Ondan Tablet 8mg by M/s Bio-Mark Pharmaceuticals
(Reg#82657)
of inspection was:
 The firm did not submit undertaking at the end of form 5.
Decision: Deferred for revision of label claim as per reference product alongwith applicable fee.
Brand Name + Dosage Form and Glip 50/1000mg Tablet
Strength
Vildagliptin………..50mg
Metformin HCl…….1000mg
03-2019
Pharmacological Group Blood glucose lowering drugs, excl. Insulins
Type of form Form-5
Approval status of product in GALVUMET® (50mg vildagliptin and 1,000mg metformin
Reference Regulatory Authorities hydrochloride) film coated tablets of TGA; Australia Approved
Me-too-status GALVUS MET 50mg/1000mg Tablets by Novartis Pharma
(Reg. No. 66107)
of inspection was:
 The firm did not submit undertaking at the end of form 5.
Brand Name + Dosage Form and Glip 50/500mg Tablet
Strength
Vildagliptin…………50mg
Metformin HCl……….500mg
03-2019
Type of form Form-5
Approval status of product in GALVUMET® (50mg vildagliptin and 500mg metformin
Reference Regulatory Authorities hydrochloride) film coated tablets of TGA; Australia Approved
Me-too-status Tinmet Tablet 50mg/500mg by M/s Bio-Mark Pharmaceuticals
(Reg. No.85718)
of inspection was:
476. Name and address of manufacture / M/s Mcolson Research Laboratories Pvt Ltd.
Applicant 26 km Lahore-Sheikhupura Road, Sheikhupura
Brand Name + Dosage Form and Mcolnac 75mg Tablets
Strength
Diclofenac potassium…..75mg
Dated 07-12-2018
Pharmacological Group NSAIDS
Type of form Form 5
Me-too-status VALRON-P 75 Tablets by Venus Pharma (Reg#78831)
GMP Status “Last GMP inspection report dated 15-02-2018 declaring
following “General Observations”: “HVAC system is
properly installed and functional in all production areas.
Overall cleanliness of the plant is good. Flow of personal
movement, material movement and process is as per cGMP.
The firm has sufficient production capacities for
manufacturing of different products in all sections.
However the firm was advised to improve documentation
system regarding validation of testing procedure and
manufacturing procedure.”
Remark of the Evaluator XI  Provide evidence of approval of applied formulation in
reference regulatory authorities / agencies which were
adopted by the Registration Board in its 275th meeting.
Decision: Deferred for evidence of applied formulation in reference regulatory authorities which
were adopted by Registration Board in 278th meeting.
477. Name and address of manufacture / M/s Stallion Pharmaceuticals Pvt Ltd 581, Sundar Industrial
Applicant Estate Lahore.
Contract Manufactured By: M/s MTI Medical Pvt Ltd. 586-
587, Sundar Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Staprazol Lyophilized Injection 40mg
Strength
Pantaprazole (as Sodium) ………....40mg
21-02-2019
Type of form Form 5
Finished product specifications Manufacturer’s Specifications
Approval status of product in Reference Protonix IV 40mg freeze-dried powder USFDA Approved
Me-too-status Pancap 40mg injection (lyophilized powder) by M/s Bio-
Labs (Reg#75060)
GMP Status GMP certificate issued to Stallion Pharmaceutical based on
inspection dated 22.11.2018
GMP certificate issued to MTI Medical based on inspection
dated 17.07.2018
Remark of the Evaluator XI  Form 5 submitted by the applicant i.e. M/s Stallion
Pharmaceuticals Pvt Ltd, as per approved format
 A copy of contract manufacturing agreement between
Stallion Pharmaceuticals and MTI Medical (Pvt) Ltd is
submitted
 The firm submitted list of 04 approved sections of
applicant. i.e. M/s Stallion Pharmaceuticals Pvt Ltd
 The firm did not have any product registered/approved on
contract manufacturing (confirmed from section)
 The firm submitted list of 09 applied products for contract
manufacturing
 Lyophilized Vials Injectable (General) section available
with MTI Medical as per licensing division letter No. F.
1-39/2005-Lic (Vol-I)

Contract Manufactured By: M/s MTI Medical Pvt Ltd.
586-587, Sundar Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Stamop Lyophilized Injection 40mg
Strength
Omeprazole (as Sodium)……40g
21-02-2019
Type of form Form 5
Finished product specifications Manufacturer’s Specifications
Approval status of product in Reference Omeprazole 40mg Powder (lyophilised powder) for
Regulatory Authorities Solution for Infusion by MHRA Approved
Me-too-status Calsic Injection 40mg IV (lyophilized powder) by M/s
Caliph Pharmaceuticals (Reg#82562)
dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)
Brand Name + Dosage Form and Staplan Lyophilized Injection 200mg
Strength
Teicoplanin…..200mg
21-02-2019
Pharmacological Group Glycopeptide antibacterials
Type of form Form 5
Approval status of product in Reference Teicoplanin 200 mg, powder (freeze-dried) for solution for
Regulatory Authorities injection/infusion or oral solution. MHRA approved
Me-too-status Tyclan 200mg lyophilized Injection by M/s MTI Medical
(Reg#087922)
dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)
Brand Name + Dosage Form and Staplan Lyophilized Injection 400mg
Strength
Teicoplanin…..400mg
21-02-2019
Type of form Form 5
Approval status of product in Reference TARGOCID teicoplanin 400mg lyophilized powder for
Regulatory Authorities injection vial with diluent ampoule. TGA approved.
Me-too-status Tyclan 400mg lyophilized Injection by M/s MTI Medical
(Reg#087923)
dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)

Brand Name + Dosage Form and Acyclostin Lyophilized Injection 250mg
Strength
Acyclovir as sodium…250mg
21-02-2019
Type of form Form 5
Approval status of product in Reference Aciclovir Powder (freeze-dried) for Infusion 250mg
Me-too-status Friclov Injection 250mg by M/s Friends Pharma
(Reg.#099856)

dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)
Brand Name + Dosage Form and E-Stamop Lyophilized Injection 40mg
Strength
Esomeprazole (as Sodium) …..…..40mg
21-02-2019
Type of form Form 5
Approval status of product in Reference NEXIUM I.V. (lyophilized cake or powder) for injection
Me-too-status ESUN Injection 40mg by M/s Unison Chemical work
(Reg.#081822)
dated 17.07.2018

submitted
manufacturing
1-39/2005-Lic (Vol-I)
Brand Name + Dosage Form and Acyclostin Lyophilized Injection 500mg
Strength
Acyclovir as sodium…500mg
21-02-2019
Type of form Form 5
Approval status of product in Reference ZOVIRAX (250mg, 500mg, 1gm) (lyophilized powder) for
Regulatory Authorities Injection USFDA Approved
Discontinued **Federal Register determination that product
was not discontinued or withdrawn for safety or efficacy
reasons**
Me-too-status Friclov Injection 500mg by M/s Friends Pharma
(Reg.#099857)
dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)
Decision: Approved.
Brand Name + Dosage Form and Stavomycin Lyophilized Injection 1gm
Strength
Vancomycin (as HCl) …..1gm
21-02-2019
Type of form Form 5
Approval status of product in Reference Vancomycin 1g Powder (porous cake) for Solution for
Regulatory Authorities Infusion MHRA Approved
Me-too-status Vinvin 1gm lyophilize Injection by M/s MTI Medical
(Reg.#084914)
dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)
Decision: Approved.
Brand Name + Dosage Form and Stavomycin Lyophilized injection 500mg
Strength
Vancomycin (as HCl)……500mg
21-02-2019
Type of form Form 5
Approval status of product in Reference Vancomycin 500mg Powder (porous cake) for Solution for
Regulatory Authorities Infusion MHRA Approved
Me-too-status Vinvin 500mg lyophilize Injection by M/s MTI Medical
(Reg.#084915)
dated 17.07.2018
submitted
manufacturing
1-39/2005-Lic (Vol-I)
Decision: Approved.
486. Name and address of manufacture / M/s Nabiqasim Industries Pvt Ltd.
Applicant 17/24, Korangi Industrial Area, Karachi, Pakistan
Brand Name + Dosage Form and Colysin Injection 1 Million IU
Strength
Colistimethate Sodium (Lyophilized Powder)……1MIU
19-02-2019
Pharmacological Group Antibacterials (polymyxins)
Type of form Form 5
Approval status of product in Reference Colistimethate Sodium 1 Million I.U. (lyophilized) Powder
Regulatory Authorities for Solution for Injection MHRA Approved
Me-too-status Colimate 1000000 IU Injection by MTI Medical
(Reg#097779)
inspection was:
Based on the areas inspected, the people met and the
documents reviewed, and considering the findings of the
inspection M/s Nabi Qasim Karachi is considered to be
operating at an acceptable level of compliance of GMP
requirements.
Remark of the Evaluator XI  The firm has claimed for BP specifications but the official
monograph is available in USP.
 The firm has lyophilized vial (General) section granted
via letter No. F. 2-20/85-Lic (Vol.III) (M-227) dated 20th
June 2011.
Decision: Approved with USP specifications.
487. Name and address of manufacture / M/s Z.Jans Pharmaceuticals Pvt Ltd.
Applicant 148-A, Hayat Abad Industrial Estate, Peshawar, Pakistan
Brand Name + Dosage Form and Cesef DS 200mg/5ml Dry Suspension
Strength
Cefixime as trihydrate….…200mg
08-02-2019
Duplicate dossier
Pharmacological Group Third-generation cephalosporins
Type of form Form 5
Approval status of product in Reference SUPRAX 200mg/5ml Dry Powder Suspension
Regulatory Authorities USFDA Approved.
Me-too-status Rofixime DS Suspension by SPL Pharmaceuticals (Pvt)
Ltd, (Reg#45506)
GMP Status The firm was inspected on 03-07-2018 & 02-08-2018 and
The firm has rectified most of the deficiencies observed
during the first visit of the panel. Keeping in view the above
and positive attitude of the firm towards improvements. The
panel unanimously recommend the grant of GMP certificate.
 The firm has submitted copy of fee challan No. 0796514
deposited on dated 06.02.2019
format but the name of the product mentioned was
different from the applied “D/S Cefest DS 200mg/5ml”.
 The firm has submitted master formulation for dry
suspension and manufacturing method outline.
Decision: Approved. Fee shall be verified as per procedure adopted in 285th meeting.
Brand Name + Dosage Form and Ibo-Z DS 200mg/5ml Suspension
Strength
Ibuprofen………200mg
08-02-2019
Duplicate dossier
Pharmacological Group NSAIDs
Type of form Form 5
Approval status of product in Reference Ibuprofen 200mg/5ml Oral Suspension (MHRA Approved)
Me-too-status Mfin Suspension 200mg/5ml M/s Bio-Mark
format
 The firm has submitted master formulation of the applied
product and manufacturing method outline.
Decision: Approved. Reference shall be sent to budget and accounts for verification of fee challan.
Brand Name + Dosage Form and Terbix DS Tablet 250mg
Strength
Composition Each tablet contains:
Terbinafine (as HCl)…….250mg
08-02-2019
Duplicate dossier
Pharmacological Group Antifungals for systemic use
Type of form Form 5
Approval status of product in Reference Terbinafine 250mg tablets MHRA Approved
Me-too-status Fibet Tablet 250mg by M/s Bio-Mark Pharmaceuticals
(Reg#85717)
 The firm has applied the product as “Terbinafine HCl
instead of Terbinafine as HCl” not considering the salt
factor. The firm did not revise the label claim as per
reference formulation and did not adjust its weight in
master formulation neither submitted applicable fee.
format
 The firm has submitted manufacturing method outline.
Decision: Deferred for revision of label claim as per reference product.
490. Name and address of manufacture / M/s GT Pharma (Pvt) Ltd. 23km, Raiwind Road, Lahore
Applicant Contract Manufactured By: M/s Medisave
Pharmaceuticals. Plot 578-579, Sundar Industrial Estate,
Lahore, Pakistan
Brand Name + Dosage Form and Nestor Syrup 4mg/5ml
Strength
Composition Each 5ml of syrup contains:
Ondansetron HCl………4mg
Dairy No. date of R &I fee Dy.No 8289 dated 25-02-2019 Rs.50,000/- Dated 25-02-
2019
Pharmacological Group Antiemetics and antinauseants (Serotonin (5HT3)
antagonists)
Type of form Form 5
Pack size and Demand Price 60ml, 120ml; As per SRO
Approval status of product in Reference ZOFRAN 4mg/5ml oral solution USFDA Approved
Me-too-status Ondan syrup 4mg/5ml by M/s Bio-mark Pharmaceuticals
(Reg#082628)
GMP Status M/s GT Pharma was inspected on 08-08-2017 and
Keeping in view the observations made on the day of
inspection and after going through the documentation and
overall operations, the panel of inspectors was of the opinion
that the firm M/s GT Pharma Lahore had maintained
conformance to GMP compliance in the manufacturing and
quality control operations.
GMP Certificate issued to M/s Medisave Pharma on 15-03-
2018 based on inspection conducted on 11-12-2017 & 10-
01-2018.
 Form 5 has been submitted the applicant i.e. M/s GT
Pharma Pvt Ltd. 23km, Raiwind Road, Lahore.

 The firm has revised the label claim along with
submission of Rs. 5000/- on deposit slip No.1957092
dated 03-08-2020. The revised label claim is as under:
Each 5ml of syrup contains:
Ondansetron HCl dihydrate eq. to Ondansetron………4mg
 The firm submitted undertaking at the end of form 5 is but
signed by the CEO of Medisave pharma and not by the
technical persons.
 The firm submitted a copy of contract manufacturing
agreement between M/s GT Pharma and M/s Medisave
Pharmaceuticals
 The firm submitted a list of 04 approved sections of
applicant
 The firm informed that they have no products already
registered/approved on contract manufacturing in the
name of applicant
 The firm submitted a list of 20 products applied on
Decision: Approved.
491. Name and address of manufacture / M/s Pharma Lord (Pvt) Ltd.
Applicant 12 KM, Lahore Road, Layyah, Punjab
Brand Name + Dosage Form and Reglin 75mg Capsule
Strength
Pregabalin……….…75mg
25-02-2019
Type of form Form-5
GMP Status Last GMP inspection was conducted on 03-05-2019 in
which the panel recommended the the renewal of DML and
grant of additional sections to M/s Pharma Lord (Pvt) Ltd.
Remark of the Evaluator XI  The firm submitted original undertaking at the end of
form 5 duly signed by the technical persons
 The firm submitted manufacturing outline for capsule.
Decision: Approved.
Applicant 12 KM, Lahore Raod, Layyah, Punjab
Strength
Pregabalin……………..50mg
25-02-2019
Type of form Form-5

Remark of the Evaluator XI  The firm submitted original undertaking at the end of
Decision: Approved.
Strength
Pregabalin……………..100mg
25-02-2019
Type of form Form-5
Remark of the Evaluator XI  The firm submitted undertaking at the end of form 5 duly
signed by the technical persons
Decision: Approved.
Brand Name + Dosage Form and Dlans 60mg Capsules
Strength
Dexlansoprazole (DDR Pellets 22.5% equivalent to
Dexlansoprazole) ………..…60mg
(Source of pellets Vision Pharma)
25-02-2019
Type of form Form 5
Pack size and Demand Price 1x10’s, 3x10’s, 10x10’s; As per SRO
Approval status of product in Reference DEXILANT (30mg, 60mg) delayed-release capsules
Me-too-status Razodex 60mg capsule by M/s Getz Pharma (Reg#086977)
Remark of the Evaluator XI  The firm submitted stability studies data of three batches
but not as per Requirements of Registration Board
decision of 293rd meeting.
 The firm submitted original undertaking at the end of
 The firm submitted valid GMP certificate of Vision
pharmaceticals (supplier of pellets)

Brand Name + Dosage Form and Dlans 30mg Capsules
Strength
Dexlansoprazole (DDR Pellets 22.5% equivalent to
Dexlansoprazole) …..…30mg
(Source of pellets Vision Pharma)
25-02-2019
Type of form Form 5
Pack size and Demand Price 1x10’s, 3x10’s, 10x10’s; As per SRO
Approval status of product in Reference DEXILANT (30mg, 60mg) delayed-release capsules
Me-too-status Razodex 30mg capsule by M/s Getz Pharma (Reg#086976)
which the panel recommended the renewal of DML and
 The firm submitted stability studies data of three batches
but not as per Requirements of Registration Board
decision of 293rd meeting.
 The firm submitted original undertaking at the end of
 The firm submitted valid GMP certificate of Vision
pharmaceuticals (supplier of pellets).
496. Name and address of manufacture / M/s Nimrall Laboratories
Applicant Plot 24, Street SS-3, Rawat, Industrial Area, Islamabad
Brand Name + Dosage Form and Hyonim 10mg Tablet
Strength
Hyoscine butylbromide ……………..10mg
25-02-2019
Type of form Form 5
Approval status of product in Reference BUSCOPAN hyoscine butylbromide 10mg sugar tablet
Regulatory Authorities TGA Approved
Me-too-status Caragen Tablets 10 mg tablet by M/s Caraway
Pharmaceuticals, (Reg#69928)
GMP Status Resumption of Production Notice was issued on 31-07-
2019
Remark of the Evaluator XI  The firm revised the label claim from uncoated to sugar
coated tablets without submission of applicable fee. The
revised label claim is as under:
Each sugar-coated tablet Contains:
Hyoscine butylbromide …………….. 10mg
Furthermore, the submitted revised master formulation

Brand Name + Dosage Form and Xynim 5mg Tablet
Strength
Levocetirizine dihydrochloride …….…5mg
25-02-2019
Pharmacological Group Piperazine derivatives
Type of form Form 5
Approval status of product in Reference XYZAL 5mg film coated tablet USFDA Approved
Me-too-status Norzin 5mg film coated tablets by M/s Nortech
Pharmaceuticals (Reg# 77965)
2019
Decision: Approved.
Brand Name + Dosage Form and Des-Zine Tablet 5mg
Strength
Desloratadine………………5mg
25-02-2019
Type of form Form 5
Approval status of product in Reference Clarinex 5mg film coated tablet USFDA Approved.
Me-too-status Desatil Tablets 5mg by Aries Pharmaceuticals
(Reg#84270)
2019
Decision: Approved.
499. Name and address of manufacture / M/s S.J & G Fazul Ellahie Pvt Ltd.
Applicant E-46, S.I.T.E. Karachi-75700
Brand Name + Dosage Form and Agomel Tablet 25mg
Strength
Agomelatine……………….25mg
25-02-2019
Type of form Form 5
Finished product specifications In-house specifications
Approval status of product in Reference Valdoxan (Agomelatine) 25mg Film-Coated Tablets TGA
Me-too-status Agoviz 25mg tablet of M/s PharmEvo (Reg#086887)
inspection was:
Based on areas visited, people met, commitment of the firm
for further improvement, it is concluded that the firm is
operating at a Good level of GMP compliance.
Decision: Approved.
500. Name and address of manufacture / M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Applicant Plot No. 129, Sundar Industrial Estate, Raiwind Road,
Lahore
Brand Name + Dosage Form and Aprowim 150mg Tablet
Strength Apromit 150mg Tablet
Irbesartan …….…. 150mg
Dairy No. date of R &I fee Form-5 Dy.No 12135 dated 06-03-2019 Rs.20,000 Dated
06-03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain
Type of form Form-5
Approval status of product in Reference ABISART 150 irbesartan 150mg film coated tablet TGA
Regulatory Authorities approved.
Me-too-status Irbisaff Tablet 150mg by M/s Saffron Pharmaceuticals
(Reg#77189)
GMP Status GMP Certificate issued on 10-12-2018.
Lahore
Brand Name + Dosage Form and Aprowim 300mg Tablet
Strength Apromit 300mg Tablet
Irbesartan …. …………..300mg
06-03-2019
Type of form Form-5
Approval status of product in Reference ABISART 300 irbesartan 300mg film coated tablet TGA
Me-too-status Irbisaff Tablet 300mg by M/s Saffron Pharmaceuticals
(Reg#77188)
Lahore
Brand Name + Dosage Form and Oseltawir 75mg Capsule
Strength Infu-Wim 75mg Capsule
Composition Each Capsule contains:
Oseltamivir phosphate equivalent to oseltamivir …. 75mg
06-03-2019
Pharmacological Group Neuraminidase Inhibitor
Type of form Form-5
Approval status of product in Reference TAMIFLU (30mg, 45mg, 75mg) capsules (USFDA
Regulatory Authorities approved).
Me-too-status Ostavir-Flu 75mg Capsule by Zafa Pharmaceutical
(Reg#42333)
Lahore
Brand Name + Dosage Form and Lorwim 25mg Tablet
Strength Lormit 25mg Tablet
Losartan Potassium …….…. 25mg
06-03-2019
Type of form Form-5
Approval status of product in Reference Cozaar 25mg film-coated tablets. MHRA approved
Me-too-status Lotass 25mg Tablet by M/s Getz Pharma (Reg# 66802)
Lahore
Brand Name + Dosage Form and Lorwim 50mg Tablet
Strength Lormit 50mg Tablet
Composition Each film coated Tablet contains:
Losartan Potassium …. 50mg
06-03-2019
Type of form Form-5
Approval status of product in Reference Cozaar 50 mg film-coated tablets. MHRA approved
Me-too-status Lotass 50mg Tablet by M/s Getz Pharma (Reg# 66803)
Lahore
Brand Name + Dosage Form and NISIM 100mg Tablet
Strength
Composition Each Tablet contains:
Nimesulide ……….. 100mg
06-03-2019
Type of form Form 5
th
Pack size and Demand Price 10’s, 20’s; As per SRO
Approval status of product in Reference ALGIMESIL 100 mg tablets AIFA Italy Approved
Me-too-status Nimcid Tablets by Unexolabs (Reg#46336)
Remark of the Evaluator XI  The firm revised master formulation and manufacturing
outline and removed coating composition and coating
procedure.
Lahore
Brand Name + Dosage Form and Passit 10mEq tablet
Strength Citro-P 10mEq tablet
Composition Each Extended release tablet contains:
Potassium Citrate …. 10mEq (1080mg)
06-03-2019
Pharmacological Group Urinary Alkalinizing agent
Type of form Form 5
Approval status of product in Reference Urocit-K Extended-release tablets USFDA Approved
Me-too-status Exocite XR 10mEq tablets by M/s Vision Pharmaceuticals
(Reg#080827)
 The firm has claimed manufacturer’s specifications but
the official monograph is available in USP.
 The firm submitted undertaking at the end of form 5 duly
signed by the technical persons.
 The firm submitted complete master formulation and
manufacturing method for the applied product.
Lahore
Brand Name + Dosage Form and Thiowim Injection 4mg/2ml
Strength
Thiocolchicoside …………… 4mg
06-03-2019
Type of form Form-5
Finished product specifications
Pack size and Demand Price 6ampx2ml; As per SRO
Approval status of product in Reference THIOCOLCHICOSIDE PHARMY II 4 mg/2 ml, solution
Regulatory Authorities for injection ampule. ANSM approved
Me-too-status Thiocol 4mg / 2ml Injection by M/s Ray Pharma
(Reg#66712)
Remark of the Evaluator XI  Firm informed the use of type I glass container as
primary packaging material of applied formulation
 The firm has applied for USP specifications and the
product is not present in available pharmacopoeias.
th
508. Name and address of manufacture / M/s Hi-Med Pharmaceuticals.
Applicant 208C Sunder Industrial Estate, Lahore, Pakistan
Brand Name + Dosage Form and Amval Tablets 5/80mg
Strength
Amlodipine besylate……5mg
Valsartan………80mg
28-02-2019
blockers (ARBs)
Type of form Form-5
Approval status of product in Reference Amlodipine/Valsartan 5mg/80mg film-coated tablets
Me-too-status Amlodine Tablet 5/80 of M/s Jupiter Pharma
(Reg.#081931)
GMP Status The firm M/s Himed Pharma was inspected on 7.04.2018,
wherein grant of DML was recommended for 4 sections.
Remark of the Evaluator XI  The firm corrected the salt form of amlodipine in the label
claim along with submission of Rs. 5000/- on deposit slip
No. 2032335 date 05-08-2020. The revised label claim is
as under;
Amlodipine as besylate……5mg
Valsartan………80mg
 They also revised coating composition from enteric
coating to film coating.
Decision: Approved.
Brand Name + Dosage Form and CE-Med 10mg Tablet
Strength
Cetirizine Dihydrochloride…….10mg
28-02-2019
Pharmacological Group Anti-Histamine
Type of form Form-5
Pack size and Demand Price 2x15’s;As per SRO
Approval status of product in Reference Cetirizine Dihydrochloride 10mg film-coated tablets
Regulatory Authorities (MHRA approved)
Me-too-status Atcet 10mg Tablet by M/s Atco LabKart. (Reg. # 83214)
Remark of the Evaluator XI  The firm submitted revised master formulation and
changed coating composition as per reference
formulation (removed Eudragit E100 which is used as
coating material for pH controlled drug release from
coating composition)
Decision: Approved.

Brand Name + Dosage Form and Hi-Claro 500mg Tablet
Strength
Clarithromycin………500mg
28-02-2019
Pharmacological Group Macrolides
Type of form Form-5
Approval status of product in Reference Clarithromycin 500mg Film-coated Tablets. MHRA
Me-too-status Clarital 500mg Tablet. By M/s Arsons Pharmaceuticals
(Reg. No. 85500)
Decision: Approved.
Brand Name + Dosage Form and Hi-Claro 250mg Tablet
Strength
Clarithromycin……………..250mg
28-02-2019
Type of form Form-5
Approval status of product in Reference Clarithromycin 250mg Film-coated Tablets. MHRA
Me-too-status Clarital 250mg Tablet. By Arsons Pharmaceuticals
Industries (Pvt) Ltd., (Reg. No. 85501)
 Undertaking at the end of form 5 not signed by the
technical persons
Decision: Approved.
Brand Name + Dosage Form and Medonac 75mg Tablet
Strength
Diclofenac sodium……………..75mg
28-02-2019
Type of form Form-5
Approval status of product in Reference VOLTAREN (25mg, 50mg, 75mg) Delayed Release/
Regulatory Authorities enteric-coated tablets USFDA Approved
Discontinued **Federal Register determination that product
reasons**
Me-too-status Torelief 75mg Tablet by M/s Maple Pharmaceuticals
(Reg.# 058203)
Remark of the Evaluator XI  Revise the 1st page of form 5 as per approved format
 Undertaking at the end of form 5 is not signed by the
technical persons.
 All the details of form 5 submitted are of the wimits
pharmaceuticals, clarify?
Decision: Deferred for clarification regarding submission of details of M/s Wimits pharmaceuticals
while applied product is for Hi-Med Pharmaceuticals
Brand Name + Dosage Form and Festat 80mg Tablet
Strength
Febuxostat…………80mg
28-02-2019
Pharmacological Group Antigout preparation
Type of form Form-5
Approval status of product in Reference ULORIC (40mg, 80mg) film coated tablets USFDA
Me-too-status Febuxin 80mg tablet by AGP Ltd (Reg. 081105)
Remark of the Evaluator XI  The firm submitted revised Form 5 as per approved
 The firm revised the label claim from uncoated to film
coated tablet along with submission of Rs. 5000/- on
deposite slip No. 2037410 dated 05-08-2020. The revised
label claim is as under;
Febuxostat…………80mg
Brand Name + Dosage Form and Fexomed 120mg Tablet
Strength
Fexofenadine HCl…………..…120mg
28-02-2019
Type of form Form-5
Approval status of product in Reference Telfast 120mg film-coated tablets, MHRA Approved.
Me-too-status Nifty 120mg Tablet by M/s Maxitech Pharma,
(Reg#83707)
Remark of the Evaluator XI  The firm revised the label claim and corrected the salt
form of fexofenadine along with submission of Rs.
The revise label claim is as under;
Fexofenadine as HCl…………..…120mg
Decision: Approved.
Brand Name + Dosage Form and Gemocin 320mg Tablet
Strength
Gemifloxacin mesylate eq to Gemifloxacin…320mg
28-02-2019
Type of form Form-5
Finished product specifications In-house
Approval status of product in Reference Factive 320mg film-coated tablet (USFDA Approved)
Me-too-status Renova 320mg Tablet by M/s Sami Pharmaceuticals
(Reg#70788)
technical persons.
Brand Name + Dosage Form and Med-Q Tablet 25mg
Strength
Quetiapine Fumarate eq to Quetiapine ………25mg
28-02-2019
Pharmacological Group Antipsychotics
Type of form Form-5
Approval status of product in Reference Quetiapine film coated tablet (25mg, 100mg, 200mg)
Regulatory Authorities MHRA Approved.
Me-too-status Qupixan Tablet 25mg by Regal Pharmaceuticals
(Reg#81960)
Decision: Approved.

Brand Name + Dosage Form and Med-Q Tablet 100mg
Strength
Quetiapine Fumarate eq to Quetiapine …….100mg
28-02-2019
Type of form Form-5
Approval status of product in Reference Quetiapine film coated tablet (25mg, 100mg, 200mg)
Me-too-status Qupixan Tablet 100mg by Regal Pharmaceuticals
(Reg#81961)
Decision: Approved.
Brand Name + Dosage Form and Risdon tablet 1mg
Strength
Risperidone……………1mg
28-02-2019
Pharmacological Group Antipsychotic
Type of form Form 5
Approval status of product in Reference Risperidone 1mg Film-Coated Tablets
Regulatory Authorities MHRA approved
Me-too-status Neo-Risp Tablet 1mg by Wilshire laboratories,
(Reg#85184)
Decision: Approved.
Brand Name + Dosage Form and Medigex 50mg Tablet
Strength
Sertraline as HCl………………50mg
28-02-2019
Type of form Form-5
Approval status of product in Reference LUSTRAL 50mg film coated tablets MHRA Approved
Me-too-status Seralin 50mg Tablet by M/s Bosch Pharmaceuticals
(Reg#83323)
Decision: Approved.
Brand Name + Dosage Form and Citamed 50mg/500mg Tablet
Strength
Sitagliptin phosphate monohydrate eq to sitaglitpin..50mg
Metformin HCl……….…500mg
28-02-2019
Pharmacological Group Antidiabetic
Type of form Form-5
Approval status of product in Reference Janumet film coated tablet (50mg/500mg & 50mg/1000mg)
Me-too-status Silmax-M 50mg/500mg Tablet by M/s High-Q
Remark of the Evaluator XI  Undertaking at the end of form 5 is not signed by the
technical persons.
Brand Name + Dosage Form and Tizamed 4mg Tablet
Strength
Tizanidine (as HCl)………4mg
28-02-2019
Type of form Form-5
Approval status of product in Reference ZANAFLEX 4mg uncoated tablets USFDA approved
Me-too-status Lozeden 4mg Tablet by M/s Lowitt Pharmaceuticals
(Reg#84231)
technical persons.
 The firm submitted revised manufacturing outline for
uncoated tablets.
Decision: Approved.
Brand Name + Dosage Form and Medviline 50mg/1000mg Tablet
Strength
Vildagliptin…………50mg
Metformin HCl……...1000mg
28-02-2019
Type of form Form 5
Approval status of product in ReferenceGALVUMET® (50mg vildagliptin and 1,000mg metformin
Regulatory Authorities hydrochloride) film coated tablets of TGA; Australia
Approved
Me-too-status GALVUS MET 50mg/1000mg Tablets by Novartis Pharma
(Reg. No. 66107)
technical persons.
Brand Name + Dosage Form and Medviline 50mg/850mg Tablet
Strength
Vildagliptin………………50mg
Metformin HCl…………….850mg
28-02-2019
Type of form Form 5
Approval status of product in Reference GALVUMET® (50mg vildagliptin and 850mg metformin
Regulatory Authorities hydrochloride) film coated tablets of TGA; Australia
Approved
Me-too-status GALVUS MET 50mg/850mg TABLETS by Novartis
Pharma (Reg. No. 66106)
Remark of the Evaluator XI  Undertaking at the end of form 5 is not signed by the
technical persons.
524. Name and address of manufacture / M/s Star Laboratories Pvt Ltd.
Applicant 23-km, Multan Road, Lahore
Brand Name + Dosage Form and Rumadol 50mg Capsule
Strength
Tramadol HCl…………50mg
20-02-2019
Pharmacological Group Opioids Analgesic
Type of form Form 5
Approval status of product in Reference Tramadol Hydrochloride 50mg Capsules. MHRA approved
Me-too-status Antram plus 50mg Capsules by Dr Raza Pharma (Reg#
84244)
GMP Status Decision of the 270th Meeting of CLB:
After thorough discussion/deliberations and
recommendation of the panel of experts in its report dated
14-05-2019, the Central Licensing Board decided to:
I- Resume production activities in Human Liquid Injection
Section (Genera-Ampoule) Only.
II- However production will remain suspended in Human
Injectable Section (Psychotropic), till the improvements
made by the firm, verification by the panel of experts.
Remark of the Evaluator XI  The firm submitted complete manufacturing outline
mentioning blistering and packing processes.
 The firm submitted undertaking available at the end of
form 5
Decision: Approved.
Brand Name + Dosage Form and Rumadol 50mg Injection
Strength
Tramadol HCl……………50mg
20-02-2019
Type of form Form 5
Approval status of product in Reference TRAMAL tramadol hydrochloride 50mg/1mL injection
Regulatory Authorities ampoule TGA Approved
Me-too-status Palmadol Injection 50mg by Palpex Pharmaceuticals
(Reg#82969)
Remark of the Evaluator XI  The firm informed that they will perform asceptic filling
and did not mentioned terminal sterilization in
 The firm informed the use of type I glass container as
 The firm submitted undertaking available at the end of
form 5
Decision: Deferred for clarification / justification for not performing terminal sterilization step for
applied formulation.
Brand Name + Dosage Form and Rumadol 100mg Injection
Strength
Tramadol HCl…..100mg
20-02-2019
Type of form Form 5
Approval status of product in Reference TRAMAL tramadol hydrochloride 100mg/2mL injection
Regulatory Authorities ampoule TGA Approved

Me-too-status Amadrol Injection 100mg/ 2 ml by M/s Amarant
Pharmacetuicals (Reg#83042)
 The firm informed that they will perform asceptic filling
and did not mentioned terminal sterilization in
 The firm informed the use of type I glass container as
Decision: Deferred for clarification / justification for not performing terminal sterilization step for
527. Name and address of manufacture / M/s Navegal Laboratories.
Applicant 41/1-A2, Phase-1, Industrial Estate, Hattar
Brand Name + Dosage Form and Libri 5/2.5mg Capsules
Strength
Chlordiazepoxide Hydrochloride…5mg
Clidinium Bromide…2.5mg
03-12-2018
Pharmacological Group Anxiolytics and anticholinergic/spasmolytic combinations
Type of form Form 5
Approval status of product in Reference Librax Capsules (USFDA Approved)
Me-too-status Could not be verified
GMP Status The firm was inspected on 11-03-2017 was found to be
operated at satisfactory level of GMP compliance.
 Letter of deficiencies sent on 10-02-2020 and reminder
on 21-05-2020 but no reply received yet
 Evidence of psychotropic section.
by DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm could not be
verified.
alongwith registration number, brand name and name of firm.
Confirmation of required manufacturing facility for applied formulation.
Brand Name + Dosage Form and Cilaaz 100mg Tablet
Strength
Cilostazol……..100mg
04-12-2018
Pharmacological Group Platelet aggregation inhibitor
Type of form Form 5
Pack size and Demand Price 10’s; 30’s; As per SRO
Approval status of product in Reference PLETAL cilostazol 100 mg tablet of Otsuka Australia
Regulatory Authorities Pharmaceutical Pvt Ltd (TGA Approved)
Me-too-status Pletaal Tablets 100mg by M/s Otsuka Pakistan Ltd,
(Reg#029295)
Remark of the Evaluator XI  Letter of deficiencies sent on 10-02-2020 and reminder
 You have applied for film coated tablets while the
reference formulation does not contain coating. Revise
the label claim and master formulation along with
Decision: Deferred for revision of label claim and master formulation as per referemce product
alongwith requisite fee.
Brand Name + Dosage Form and Ozap 100mg Tablet
Strength
Clozapine…100mg
03-12-2018
Type of form Form 5
Approval status of product in Reference Clozaril tablets (USFDA Approved)
Me-too-status Zydex-100 Tablets by Genome Pharmaceuticals (Pvt,) Ltd
(Reg#53559)
Decision: Deferred for revision of label claim and master formulation as per referemce product
Brand Name + Dosage Form and Ozap 25mg Tablet
Strength
Clozapine…25mg
03-12-2018
Type of form Form 5
Approval status of product in Reference Clozaril tablets (USFDA Approved)

Me-too-status Zydex-25 Tablets by Genome Pharmaceuticals (Pvt,) Ltd
(Reg#53558)
Decision: Deferred for revision of label claim and master formulation as per reference product
Brand Name + Dosage Form and Cindela 450mg Tablet
Strength
Delafloxacin (as meglumine)…450mg
04-12-2018
Type of form Form 5
Approval status of product in Reference BAXDELA Tablets 450 mg (USFDA Approved)
Me-too-status
Revision of label claim and master formulation alongwith applicable fee.
Brand Name + Dosage Form and Emplina 10/5mg Tablets
Strength
Empagliflozin…10mg
Linagliptin……..5mg
03-12-2018
Type of form Form 5
Pack size and Demand Price 10’s; 20’s; 14’s; 30’s; As per SRO
Approval status of product in Reference GLYXAMBI (USFDA Approved)
Me-too-status
 You have applied for uncoated tablets while the reference
formulation is film coated. Revise the label claim and
master formulation along with submission of applicable
fee.
Submission of application on Form-5D alongwith applicable fee.
Submission of stability study data as per guidelines provided in 293rd meeting of Registration
Board.
Brand Name + Dosage Form and Emplina 25/5mg Tablets
Strength
Empagliflozin…25mg
Linagliptin…5mg
03-12-2018
Type of form Form 5
Approval status of product in Reference GLYXAMBI (USFDA Approved)
Me-too-status
fee.
Board.
Brand Name + Dosage Form and Ertusit 15/100mg Tablet
Strength
Composition Each Film coated Tablet Contains:
Ertugliflozin (L-pyroglutamic acid)…15mg
Sitagliptin (Phosphate Monohydrate)…100mg
03-12-2018
Type of form Form 5
Approval status of product in Reference STEGLUJAN (USFDA Approved)
Me-too-status
 The applied formulation is also not as per reference
formulation, revise the formulation along with
submission of fee.
Board.
Brand Name + Dosage Form and Metiva 5/50mg Tablet
Strength
Ivabradine (as HCL)…5mg
Metoprolol Tartrate…50mg
03-12-2018
Pharmacological Group Beta blocking agents, other combinations
Type of form Form 5
Approval status of product in Reference IMPLICOR 5 mg / 50 mg film-coated tablet
Regulatory Authorities (ANSM France Approved)
Me-too-status Implicor 5/50 mg of Serveir and Research Pharmacuticals
Pakistan (Reg#099006)
fee.
Board.
Brand Name + Dosage Form and Metiva 7.5/50mg Tablet
Strength
Ivabradine (as HCl)…7.5mg

03-12-2018
Pharmacological Group Beta blocking agents, other combinations
Type of form Form 5
Approval status of product in Reference IMPLICOR 7.5 mg / 50 mg film-coated tablet (ANSM
Regulatory Authorities France Approved)
Me-too-status
 The submitted formulation does not contain coating while
the reference formulation is film coated. Revise the label
claim and master formulation along with submission of
applicable fee.
Board.
Brand Name + Dosage Form and Maciten 10mg Tablet
Strength
Macitentan…10mg
03-12-2018
Pharmacological Group Antihypertensives for pulmonary arterial hypertension
Type of form Form 5
Approval status of product in Reference OPSUMIT 10mg tablet USFDA Approved
Me-too-status
 The submitted manufacturing outline doesd not contain
coating process. Submit complete manufacturing outline.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand name and name of firm or else submit
stability study data as per guidelines provided in 293rd meeting of Registration Board.
Brand Name + Dosage Form and Oxego 25mg Tablets
Strength
Naloxegol (as Oxalate)…25mg
03-12-2018
Pharmacological Group Peripheral opioid receptor antagonists
Type of form Form 5
Approval status of product in Reference MOVANTIK 25mg tablets USFDA Approved
Me-too-status
Brand Name + Dosage Form and Perfen Tablet 801mg
Strength
Pirfenidone…801mg
03-12-2018
Pharmacological Group Immunosuppressants
Type of form Form 5
Approval status of product in Reference ESBRIET film-coated tablets USFDA Approved
Me-too-status
Submission of application on Form-5D alongwith differential fee.
Board.
Brand Name + Dosage Form and Riocit 0.5mg Tablet
Strength
Riociguat…0.5mg
03-12-2018
Type of form Form 5
Approval status of product in Reference ADEMPAS 0.5mg tablets USFDA Approved
Me-too-status
541. Name and address of manufacture / M/s Navegal Laboratories.,
Brand Name + Dosage Form and Riocit 1.5mg Tablet
Strength
Riociguat…1.5mg
03-12-2018
Type of form Form 5
Approval status of product in Reference ADEMPAS 1.5mg tablets USFDA Approved
Me-too-status
 The submitted manufacturing outline does not contain
Brand Name + Dosage Form and Riocit 1mg Tablet
Strength
Riociguat…1mg
03-12-2018
Type of form Form 5
Approval status of product in Reference ADEMPAS 1mg tablets USFDA Approved
Me-too-status
 The submitted manufacturing outline does not contain
Brand Name + Dosage Form and Zonisa 100mg Capsule
Strength
Zonisamide…100mg
03-12-2018
Type of form Form 5
Approval status of product in Reference ZONEGRAN 100mg capsules USFDA Approved
Me-too-status Seizof 100mg Capsule of OBS Pakistan Reg#73644)

Decision: Deferred for GMP inspection report within the period of 3 years.
Brand Name + Dosage Form and Zonisa 50mg Capsule
Strength
Zonisamide…50mg
03-12-2018
Type of form Form 5
Approval status of product in Reference Zonisamide Warren 50mg capsule MHRA Approved
Me-too-status Seizof 50mg Capsule of OBS Pakistan Reg#73643)

Decision: Deferred for GMP inspection report during last 3 years.

Brand Name + Dosage Form and Onidi ER 0.1mg Tablet
Strength
Clonidine HCl…0.1mg
04-12-2018
Pharmacological Group Antiadrenergic Agents
Type of form Form 5
Approval status of product in Reference KAPVAY 0.1mg extended-release tablets USFDA
Me-too-status
 You have applied film coated tablets while the reference
formulation is uncoated extended release, revise the
master formulation alongwith submission of applicable
fee.
/ me-too status) alongwith registration number, brand name and name of firm.
Brand Name + Dosage Form and Onidi ER 0.2mg Tablet
Strength
Clonidine HCl…0.2mg
04-12-2018
Pharmacological Group Antiadrenergic Agents
Type of form Form 5
Approval status of product in Reference KAPVAY 0.2mg extended-release tablets USFDA
Discontinued “Federal Register determination that product
reasons”
Me-too-status
 You have applied film coated tablets while the reference
formulation is uncoated extended release, revise the
master formulation alongwith submission of applicable
fee.
Brand Name + Dosage Form and Difural 240mg Capsules
Strength
Composition Each gastro-resistant hard capsule contains:
Dimethyl Fumarate…240mg
04-12-2018
Type of form Form 5
Approval status of product in Reference TECFIDERA delayed-release capsules, USFDA Approved
Me-too-status
 You have applied for delayed release pellets filled into
hard gelatin capsules, while the reference formulations
contain enteric coated microtablets filled into hard gelatin
capsule. Justify? Or revise the label claim and master
formulation along with submission of applicable fee.
 Provide evidence of machinery used for manufacturing of
microtablets.
Brand Name + Dosage Form and Vermeil DR 10/10mg Tablet
Strength
Composition Each film coated delayed Release Tablet contains:
Doxylamine Succinate…10mg
Pyridoxine HCl…10mg
04-12-2018
Type of form Form 5
Me-too-status Omit 10/10 mg Tablet by Scilife Pharma (Reg#82087)
 The reference formulation is film coated delayed release
tablets while the applied product manufacturing outline
does not contain any such steps. Please revise the
manufacturing outline as per reference formulation
Decision: Deferred for revision of manufacturing outline as per reference formulation.

Brand Name + Dosage Form and Ezecol 10mg Tablets
Strength
Ezetimibe…10mg
04-12-2018
Pharmacological Group Lipid Lowering Agents
Type of form Form 5
Approval status of product in Reference Zetia Tablet MHRA Approved
Me-too-status Preveze Tablets 10 mg by Highnoon Laboratories,
(Reg#42566)
reference formulation is uncoated tablets. Revise the label
and master formulation alongwith submission of
applicable fee.
Decision: Deferred for revision of label claim and master formulation alongwith applicable fee.
Brand Name + Dosage Form and Laurel 40mg Tablet
Strength
Lurasidone HCl…40mg
04-12-2018
Pharmacological Group Anti-psychotic
Type of form Form 5
Approval status of product in Reference Approved by TGA of Australia
Me-too-status Luda 40mg tablets of Genome pharmaceuticals
(Reg#095154)
 The applied formulation is film coated tablets while the
submitted manufacturing outline does not contain coating
process. Submit complete manufacturing outline
accordingly
Brand Name + Dosage Form and Laurel 80mg Tablet
Strength
Lurasidone HCl…80mg
04-12-2018
Type of form Form 5
Approval status of product in Reference Approved by TGA of Australia
Me-too-status Rasidon 80mg tablets of Hilton pharma (Reg#089371)
accordingly
Brand Name + Dosage Form and Begron ER 25mg Tablets
Strength
Mirabegron…..…25mg
04-12-2018
Pharmacological Group Urinary Anti- spasmodics
Type of form Form 5
Approval status of product in Reference MYRBETRIQ extended-release tablets USFDA Approved
Me-too-status Mirabet 25mg tablets of CCL Pharma (Reg#090378)
 The applied formulation needs submission of six months
accelerated and real time stability studies data as the
applied formulation is subsequent drug generic version.
accordingly
Brand Name + Dosage Form and Begron ER 50mg Tablets
Strength
Mirabegron…..…50mg
04-12-2018
Pharmacological Group Urinary Anti- spasmodics
Type of form Form 5
Approval status of product in Reference MYRBETRIQ extended-release tablets USFDA Approved
Me-too-status Mirabet 50mg tablets of CCL Pharma (Reg#090503)
 The applied formulation needs submission of six months
accelerated and real time stability studies data as the
applied formulation is subsequent drug generic version.
accordingly
Brand Name + Dosage Form and Rofumil 500µg Tablets
Strength
Roflumilast………...500µg
04-12-2018
Pharmacological Group Other systemic drugs for obstructive airway diseases
Type of form Form 5
Approval status of product in Reference Daxas 500µg film-coated tablets EMA Approved
Me-too-status Omlast 500µg tablets by Genix Pharma (Reg#100192)
 Submission of stability studies data as per Requirements of
Registration Board decision of 251st meeting.
accordingly
Brand Name + Dosage Form and Fampira 10mg Tablets
Strength
Amifampridine……10mg
07-12-2018
Pharmacological Group Other nervous system drugs
Type of form Form 5
Approval status of product in Reference RUZURGI tablets USFDA Approved
Me-too-status
 The applied formulation is uncoated tablets while you
have mentioned film coating in master formulation.
Revise the master formulation accordingly
/ me-too status) alongwith registration number, brand name and name of firm or else submit of
Brand Name + Dosage Form and Aprem 10mg Tablets
Strength
Apremilast…….…10mg
07-12-2018
Pharmacological Group Selective immunosuppressants
Type of form Form 5
Approval status of product in Reference OTEZLA tablet USFDA Approved
Me-too-status
accordingly
 Signature of the technical staff is missing on the
undertaking.
Board.
Brand Name + Dosage Form and Aprem 30mg Tablets
Strength
Apremilast……….30mg
07-12-2018
Pharmacological Group Selective immunosuppressants
Type of form Form 5
Approval status of product in Reference OTEZLA tablet USFDA Approved
Me-too-status
accordingly
Board.
Brand Name + Dosage Form and Colozid 1.1g Tablet
Strength
Balsalazide Disodium…1100mg
07-12-2018
Pharmacological Group Aminosalicylic acid and similar agents
Type of form Form 5
Me-too-status
 Provide evidence of approval of applied formulation in
accordingly
Decision: Deferred for followings:
 Evidence of approval of applied formulation in reference regulatory authorities / agencies which
were adopted by the Registration Board in its 275th meeting
Brand Name + Dosage Form and Bivoson 5/80mg Tablets
Strength
Nebivolol (as HCL)….…5mg
Valsartan………………...80mg
07-12-2018
Pharmacological Group B-adrenergic Receptor blocking Agent, Angiotensin II
Receptor Blocker
Type of form Form 5
Me-too-status
accordingly
Decision: Deferred for followings:
Evidence of approval of applied formulation in reference regulatory authorities / agencies which
were adopted by the Registration Board in its 275th meeting
Brand Name + Dosage Form and Prandlin 1mg Tablet
Strength
Repaglinide……..1mg
07-12-2018
Pharmacological Group Other blood glucose lowering drugs, excl. insulins
Type of form Form 5
Me-too-status Repag 1mg Tablet by Getz Pharma (Pvt)Ltd, (Reg#57891)
 You have applied for film coated tablet while the
reference formulation is uncoated. Revise the label claim
and master formulation along with submission of
applicable fee.
Decision: Deferred for revision of label claim and master formulation as per reference formulation
alongwith applicable fee and GMP inspection during 3 years.
Brand Name + Dosage Form and Pental ER 200mg Tablet
Strength
Composition Each extended release film coated tablet contains:
Tapentadol (as HCl)………200mg
07-12-2018
Type of form Form 5
Approval status of product in Reference NUCYNTA ER extended-release tablets USFDA Approved
Me-too-status Tapento XR tablets by Sami Pharmaceuticals (Reg#93062)
 Submission of stability studies data as per Requirements
of Registration Board decision of 251st meeting.
accordingly
Brand Name + Dosage Form and Pental 100mg Tablet
Strength
Tapentadol (as HCl)….…100mg
07-12-2018
Type of form Form 5
Approval status of product in Reference NUCYNTA tablets USFDA Approved
Me-too-status
 You have applied for film coated tablets while master
formulation and manufacturing outline does not contain
film coating ingredients and coating process. Submit
master formulation and complete manufacturing outline
Brand Name + Dosage Form and Pental 50mg Tablet
Strength
Tapentadol (as HCl)…50mg
07-12-2018
Type of form Form 5
Approval status of product in Reference NUCYNTA tablets USFDA Approved
Me-too-status
accordingly
564. Name and address of manufacture / M/s Neutro Pharma (Pvt) Ltd.
Applicant Sheikhupura Road, Lahore
Brand Name + Dosage Form and Stazic Tablet 50mg
Strength
Cilostazol………………50mg
01-03-2019
Pharmacological Group Antithrombotic Agents
Type of form Form-5
Approval status of product in Reference PLETAL cilostazol 50 mg tablet (TGA Approved)
Me-too-status Plator Tablet 50mg by M/s Don Valley Pharmaceuticals
(Reg#69367)
GMP Status The firm was inspected on 21,23-08-2017 by a panel of
inspectors and conclusion of inspections was:
Panel inspected the unit and evaluated documentation
regarding production, quality control and quality assurance.
Panel discussed various technical aspects with the technical
staff at length. Panel decided to recommend the renewal of
DML of M/s Neutro Pharma for the approved sections by
the Central Licensing Board.

Decision: Approved.
Brand Name + Dosage Form and Pride 50mg Tablet
Strength
Itopride HCl………………50mg
01-03-2019
Type of form Form 5
Pack size and Demand Price 10, 20, 40, 90, 100; As per SRO
Approval status of product in Reference Ganaton 50mg tablet (PMDA) Japan Approved
Me-too-status Xepride tablet 50mg of M/s Usawa Pharmaceuticals (Reg.
# 076818)
Decision: Approved.
Applicant Sheikhupura Road, Lahore.
Brand Name + Dosage Form and Nusyn 30mg Tablet
Strength
Nimodipine……………30mg
01-03-2019
Pharmacological Group Selective Calcium Channel Blockers With Mainly Vascular
Effects
Type of form Form-5
Approval status of product in Reference Nimotop 30mg film coated Tablets Of MHRA approved
Me-too-status Nimovas 30mg Tablet by M/s Spencer Pharma
(Reg#67697)
Decision: Approved.

Brand Name + Dosage Form and Pinrole 2mg Tablet
Strength
Ropinirole as HCl…………..…2mg
01-03-2019
Type of form Form-5
Approval status of product in Reference REQUIP (0.25, 0.5, 1, 2, 3, 4, or 5mg) film-coated tablets,
Regulatory Authorities USFDA approved
Me-too-status XMG 2mg Tablet by M/s Atco Labs (Reg#50524)
Remark of the Evaluator XI  The applicant have claimed manufacturer’s
specifications but the official monograph is available in
USP.
Decision: Approved.
Brand Name + Dosage Form and Pinrole 1mg Tablet
Strength
Ropinirole as HCl….…………1mg
01-03-2019
Type of form Form-5
Approval status of product in Reference REQUIP (0.25, 0.5, 1, 2, 3, 4, or 5mg) film-coated tablets,
Me-too-status XMG 1mg Tablet by M/s Atco Labs (Reg#50523)
USP.
Decision: Approved.
Brand Name + Dosage Form and Vorzol Tablet 50mg
Strength

Voriconazole………..…50mg
01-03-2019
Pharmacological Group Anti- fungal
Type of form Form-5
Finished product specifications Manufacturers
Pack size and Demand Price 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 500; As per
SRO
Approval status of product in Reference VFEND (50 mg, 200 mg) film-coated tablets, USFDA
Me-too-status Voric 50mg Tablet by M/s Genix Pharma (Reg. #83916)

USP.
570. Name and address of manufacture / M/s Amros Pharmaceuticals
Applicant A-96, S.I.T.E, Super Highway, Karachi
Brand Name + Dosage Form and Pseudoephedrine 30mg Tablet
Strength
Pseudoephedrine………………30mg
01-03-2019
Pharmacological Group Sympathomimetics
Type of form Form 5
Pack size and Demand Price 1000’s jar; As per SRO
Me-too-status Pseudoephedrine 30mg Tablet by M/s Safe Pharmaceuticals
(Reg.#66739)
GMP Status Last GMP inspection conducted on 18-07-2018 and
Based on the above facts the current compliance level is
rated as good
 On 1st page of form 5 and cover letter you have mentioned
both pseudoephedrine 30mg tablet (ephedrine 30mg
tablet), while in label claim you have mentioned
pseudoephedrine 30mg tablet. Clarify?
 Fee is deposited on two deposit slips having No. 0829570
dated 01-03-2019 of Rs. 15000/- and 709580 dated 01-
03-2019 of Rs. 5000/- and pseudoephedrine 30mg tablet
is mentioned on both the slips while on verification of fee
challan from budget and accounts ephedrine 30mg tablet
is mentioned.
 Salt form of API (HCl)
 Undertaking at the end of form 5 is missing
adopted by the Registration Board in its 275th meeting
along with weblink
 Provide evidence of manufacturing facility/section
approval for the applied formulation
Brand Name + Dosage Form and T-One 2mg Tablet
Strength
Lorazepam………………2mg
Dairy No. date of R &I fee Dy. No 9460 dated 01-03-2019, Rs.20,000/- Dated 01-03-
2019
Pharmacological Group Benzodiazepine derivatives
Type of form Form 5
Approval status of product in Reference Ativan (0.5mg, 1mg, 2mg) tablet USFDA Approved
Me-too-status Lorazepam 2mg Tablets by M/s Heal Pharmaceuticals
(Reg.#79397)
rated as good
Remark of the Evaluator XI  Fee is deposited on two deposit slips having No. 0829563
03-2019 of Rs. 5000/-
 The firm submitted letter No.F. 2-8/93-Lic (Vol-III) dated
25th June 2019 issued by Secretary Central Licensing
Board showing Tablet (Psychotropic) (Amendents).
Decision: Deferred for submission of undertaking.
Brand Name + Dosage Form and T-One 1mg Tablet
Strength
Lorazepam………………1mg
01-03-2019
Type of form Form 5
Approval status of product in Reference Ativan (0.5mg, 1mg, 2mg) tablet USFDA Approved
Me-too-status Lorazepam 1mg Tablets by M/s Heal Pharmaceuticals
(Reg.#79396)
rated as good

Remark of the Evaluator XI  Fee is deposited on two deposit slips having No. 0829564
03-2019 of Rs. 5000/-
25th June 2019 issued by Secretary Central Licensig
Board showing Tablet (Psychotropic) (Amendents)
Decision: Deferred fot submission of undertaking.
Brand Name + Dosage Form and Anax 1mg Tablet
Strength
Alprazolam………………1mg
01-03-2019
Type of form Form 5
Approval status of product in Reference Xanax (0.25mg, 0.5mg, 1mg, 2mg) tablets USFDA
Me-too-status Lydia 1mg Tablets by M/s. Wilshire Laboratories
(Reg#65699)
rated as good
Remark of the Evaluator XI  You have submitted the fee on two deposit slip slips
having No. 0829555 dated 01-03-2019 of Rs. 15000/- and
709564 dated 01-03-2019 of Rs. 5000/-. The product
name is mentioned on both the slips, however the strength
on deposit slip No. 0829555 dated 01-03-2019 of Rs.
15000/- is 1gm while the strength mentioned on deposit
slip No. 709564 dated 01-03-2019 of Rs. 5000/- is 1mg
and the applied product is also 1mg tablet. The firm was
asked for submission of differential fee for the applied
product. In response the firm submitted undertaking that
the said undertaking (No. 0829555 dated 01-03-2019 of
Rs. 15000/-, 1gm) is used only for the applied product
(Anax 1mg tablet) and they will not use it for any other
product.
 The firm submitted revised form 5 mentioned a single
strength of 1mg both in form 5 and lable claim.
 The firm revised the label claim from film coated to
deposit slip No. 1901748 dated 02-09-2020. The revised
Alprazolam………………1mg
Decision: Deferred for submission of fresh fee challan with correct strength of applied formulation.

Brand Name + Dosage Form and Anax 0.5mg Tablet
Strength
Alprazolam………………0.5mg
01-03-2019
Type of form Form 5
Approval status of product in Reference Xanax (0.25mg, 0.5mg, 1mg, 2mg) tablets USFDA
Me-too-status Lydia 0.5mg Tablets by M/s Wilshire Laboratories
(Reg#65705)
rated as good
 Fee is deposited on two deposit slips having No. 0829551
03-2019 of Rs. 5000/-
 The firm revised the label claim from film coated to
deposit slip No. 1901747 dated 02-09-2020. The revised
Alprazolam………………0.5mg
Decision: Deferred for submission of fresh fee challan with correct strength of applied formulation.
575. Name and address of manufacture / M/s Ferozsons Laboratories Ltd.
Brand Name + Dosage Form and Daxalta Capsule 40mg
Strength
Duloxetine HCl (as delayed release pellets 20% w/w) eq to
Duloxetine..……….40mg
Source: Alphamed Formulations Pvt. Ltd India
25-02-2019
Pharmacological Group Other antidepressants
Type of form Form 5
Approval status of product in Reference Duloxetine 40mg gastro-resistant capsules, MHRA
Me-too-status Dulife 40mg capsules of M/s Evolution Pharmaceuticals
(Reg. 091962)
GMP Status Panel inspection dated 10-01-2018 recommends grant of
GMP certificate.

Decision: Approved.

Strength
Duloxetine..…30mg
2019
Type of form Form 5
Approval status of product in Reference CYMBALTA (20mg, 30mg, 60 mg) delayed-release
Regulatory Authorities capsules USFDA Approved
(Reg. 091961)
GMP certificate.
Decision: Approved.
Strength
Duloxetine..…60mg
25-02-2019
Type of form Form 5
Me-too-status Dulife capsules 60mg capsules of M/s Evolution
Pharmaceuticals (Reg. 091963)
GMP certificate.
Decision: Approved
Strength
Duloxetine..…20mg
25-02-2019
Type of form Form 5

(Reg. 091960)
GMP certificate.
Decision: Approved.
579. Name and address of manufacture / M/s Seraph Pharmaceuticals.
Applicant Plot No. 210, Industrial Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form and Lycenil Lotion 5% w/w
Strength
Composition Each gram of lotion contains:
Permethrin……………….50mg (5% w/w)
01-03-2019
Pharmacological Group Ectoparasiticides, Incl. Scabicides, Insecticides And
Repellents
Type of form Form 5
Pack size and Demand Price 60ml, 120ml; As per SRO
Approval status of product in Reference Permethrin Lotion 5% w/w (MHRA Approved)
Me-too-status Plaveo Lotion by M/s Hiranis Pharmaceuticals
(Reg.#76508)
GMP Status “GMP certificate issued on 03-07-2018.”
Remark of the Evaluator XI  The firm submitted letter No. F. 1-16/2016-Lic dated 12th
June 2017 from secretary central licensing board
confirming Ceam/Ointment and Lotion section
 The firm submitted undertaking at the end of form 5 duly
signed by the technical persons
Decision: Approved with change of brand name.
Brand Name + Dosage Form and Lutico Nasal Spray 50mcg/spray
Strength
Composition Each spray contains:
Fluticasone Propionate……………….50mcg
05-03-2019
Type of form Form 5
Pack size and Demand Price 120 sprays; As per SRO
Approval status of product in Reference Nasofan Allergy 50 microgram Nasal Spray
Regulatory Authorities Each 100 microlitre metered spray contains 50 microgram
(mcg) of fluticasone propionate. MHRA Approved
Me-too-status Flexosone Nasal Spray by M/s Schazoo Laboratories
(Reg.#40863)
confirming Ceam/Ointment and Lotion section.
Furthermore the firm informed that their product is lotion
and for convenience of use, they packed it in a spray or
dropper like bottle.

 The firm deposited fee Rs. 5000/- on deposit slip No.
2049524 dated 01-09-2020 but did not revise the label
claim as per reference formulation. The correct label
claim as per reference formulation is “Each 100 microlitre
metered spray contains 50 microgram (mcg) of
fluticasone propionate”
 Confirmation of required manufacturing facility for applied formulation.
 Revision of label claim as per reference formulation.
Brand Name + Dosage Form and Furamet nasal spray 50mcg/spray
Strength
Composition Each spray contains:
Mometasone furoate as monohydrate…………….50mcg
05-03-2019
Type of form Form 5
Pack size and Demand Price 60 sprays, 120 sprays, 140 sprays; As per SRO
Approval status of product in Reference Mometasone furoate 50 micrograms/actuation nasal spray,
Regulatory Authorities suspension MHRA Approved
Each actuation (100 mg) contains 50 micrograms of
mometasone furoate (as the monohydrate) as delivered dose
(ex actuator).
Me-too-status Memocart nasal spray by M/s Platinum Pharma
(Reg.#36585)
confirming Ceam/Ointment and Lotion section.
Furthermore the firm informed that their product is lotion
and for convenience of use, they packed it in a spray or
dropper like bottle.
 The firm deposited fee Rs. 5000/- on deposit slip No.
2049523 dated 01-09-2020 but did not revise the label
claim as per reference formulation. The correct label
claim is “Each actuation (100 mg) contains 50
micrograms of mometasone furoate (as the monohydrate)
as delivered dose (ex actuator)”
 The reference formulation is a suspension nasal spray,
while the master formulation of the applied formulation
shows that it is a solution. The firm revised the master
formulation as per reference formulation without
submission of fee.
 Confirmation of required manufacturing facility for applied formulation.
582. Name and address of manufacture / M/s Kanel Pharma. Plot # 6, St # SS-3, National Industrial
Applicant Zone, Rawat, Rawalpindi.
Contract Manufactured By: M/s English Pharmaceuticals
Industries. Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore
Brand Name + Dosage Form and Icare 40mg dry powder Injection
Strength

Omeprazole (as Sodium) ………..40mg
07-03-2019
Type of form Form 5
Approval status of product in Reference OMEPRAZOLE SANDOZ IV omeprazole (as sodium)
Regulatory Authorities 40mg powder for injection vial (TGA Approved)
Me-too-status Prisma 40mg IV Injection by M/s Rasco Pharma
(Reg#82762)
GMP Status M/s Kanel Pharma was inspected on 06-03-2019 and
recommendations of inspection was:
Keeping in view the above stated observations during
inspection, areas visited, documents reviewed it is
concluded that M/s Kanel Pharma Rawat is operating in
compliance to GMP guidelines as of today. However the
points of improvements have been discussed and agreed by
the representatives of the firm.
Certificate of GMP Issued to English Pharmaceuticals on
16-01-2018.
Remark of the Evaluator XI  Form 5 has been submitted by the applicant duly signed
by the signatory
 The firm did not submit undertaking at the end of form 5
M/s Kanel Pharma and M/s English Pharmaceuticals
Industries is submitted
applicant. i.e. M/s Kanel Pharma
 The firm informed that they don’t have any product
registered/approved on contract manufacturing
manufacturing
 The firm mentioned the use of type II glass container as
Multan Road, Lahore
Brand Name + Dosage Form and Engferol Injection 5mg/ml Oral/IM
Strength
Cholecalciferol (vitamin D3)………….5mg (200,000IU)
05-03-2019
Pharmacological Group Vitamin D3 analogue
Type of form Form 5
Pack size and Demand Price 1mlx1’s; 1mlx5’s; As per SRO
Approval status of product in Reference Vitamin D3 Good 200,000 IU/1ml oral solution in ampoule
Regulatory Authorities ( ANSM France approved)
Vitamin D3 Good 200,000 IU/1ml IM solution for
injection ( ANSM France approved)

Me-too-status D-Rick Injection by Caliph Pharmaceuticals (Pvt.) Ltd,
(Reg#82563)
16-01-2018.
 Form 5 has been submitted by the applicant duly signed
by the signatory
manufacturing
 The firm informed that they are using asceptic technique
for filling so need no terminal sterilization process.
Decision: Deferred for submission of undertaking.
Multan Road, Lahore
Brand Name + Dosage Form and Escare 40mg dry powder Injection
Strength
Esomeprazole (as Sodium)………40mg
07-03-2019
Type of form Form 5
Approval status of product in Reference Esomeprazole 40mg Powder for Solution for
Regulatory Authorities Injection/Infusion MHRA Approved
Me-too-status Esobrain Injection 40mg by M/s WinBrains Research
Laboratories, (Reg#85072)

16-01-2018.
by the signatory
manufacturing
Multan Road, Lahore
Brand Name + Dosage Form and Anzifur Injection 100mg/5ml
Strength
Iron sucrose complex eq to elemental iron………100mg
06-03-2019
Pharmacological Group Anti-anaemic
Type of form Form 5
Approval status of product in Reference Venofer (50mg/2.5mL, 100mg/5mL, 200mg/10mL)
Regulatory Authorities (20mg/mL) in single-dose vials. Injection USFDA
Approved
Me-too-status Irofit Injection 100mg/5ml by M/s Zafa Pharma
(Reg#82291)
16-01-2018.
by the signatory
manufacturing
Decision: Deferred for clarification regarding use type of primary packaging material for applied
formulation and submission of undertaking.
Multan Road, Lahore
Brand Name + Dosage Form and Kanprazole 40mg dry powder Injection
Strength
Pantoprazole (as Sodium sesquihydrate) ……….…40mg
07-03-2019
Type of form Form 5
Approval status of product in Reference Pantoprazole 40mg Powder for Solution for Injection
Me-too-status Panpak 40mg IV Injection by M/s Rasco Pharma
(Reg#82763)
16-01-2018.
by the signatory
manufacturing
 The firm did not submitted revised master formulation
adjusting the weight of API considering the hydrated form
Multan Road, Lahore
Brand Name + Dosage Form and Anzi-Cilin 4.5g Dry Powder Injection
Strength
Piperacillin (as Sodium)…………..4g
Tazobactam (as Sodium)…………..0.5g
05-03-2019
Type of form Form 5
Approval status of product in Reference ZOSYN (piperacillin and tazobactam, 4gm/0.5gm) for
Regulatory Authorities injection, for intravenous use. USFDA approved
Me-too-status Tacip 4.5gm Injection by M/s Macter Int. (Reg#73632)
16-01-2018.
 Form 5 has been submitted by the applicant duly signed
by the signatory
manufacturing
Decision: Deferred for clarification regarding type of primary packaging material for applied
formulation and submission of undertaking.
588. Name and address of manufacture / M/s ICI Pakistan Limited.
Applicant S-33, Hawksbay, S.I.T.E, Karachi
Brand Name + Dosage Form and Eyrin Forte Tablets 275mg/150mg/75mg
Strength
Ethambutol HCl……….275mg
Rifampicin…………….150mg
Isoniazid……………….75mg
04-03-2019
Pharmacological Group Combinations of drugs for treatment of tuberculosis
Type of form Form 5
Finished product specifications JP
Pack size and Demand Price 80’s, 10x10’s; As per SRO
Approval status of product in Reference Rifampicin/Isoniazid/Ethambutol hydrochloride
Regulatory Authorities 150mg/75mg/275mg film coated Tablets (WHO Approved
formulation)
Me-too-status Myrin Forte Tablet by M/s Wyeth Pakistan (Reg. No.
75891)
GMP Status Last GMP inspection was conducted on 25-01-2018 and
conclusion of inspection was;
documents reviewed and considering the findings of
inspection M/s ICI Pakistan Ltd Kasur was considered to be
GMP compliant with reference to GMP guidelines as per
Drugs Act, 1976 and rules framed there under.
Remark of the Evaluator XI  The firm revise the 1st page of form 5 as per prescribed
format duly signed by authorized person and submitted
original documents and undertaking at the end of form 5.
 The firm revise the label claim from uncoated to film
coated tablets along with submission of Rs. 5000/- on
deposit slip No. 2037971 date 28-08-2020. The revised
Ethambutol HCl……….275mg
Rifampicin…………….150mg
Isoniazid……………….75mg
Brand Name + Dosage Form and Eyrin-P forte Tablets 275mg/150mg/75mg/400mg
Strength
Ethambutol HCl………275mg
Rifampicin……………150mg
Isoniazid…………...…75mg
Pyrazinamide…………400mg
04-03-2019
Type of form Form 5
Approval status of product in Reference Rifampicin 150 mg/ Isoniazid 75 mg/ Pyrazinamide 400
Regulatory Authorities mg/Ethambutol Hydrochloride 275 mg film coated Tablets
(WHO Approved formulation)
Me-too-status Myrin P Forte Tablets by M/s Pfizer Pakistan Ltd
(Reg#027082)
 The firm revised the 1st page of form 5 as per prescribed
Brand Name + Dosage Form and Eyrin-P Tablets 225mg/120mg/60mg/300mg
Strength

Ethambutol HCl………225mg
Rifampicin……………120mg
Isoniazid………………60mg
Pyrazinamide…………300mg
04-03-2019
Type of form Form 5
Me-too-status
adopted by the Registration Board in its 275th meeting
along with weblink.
Brand Name + Dosage Form and Eyrin Tablets 300mg/150mg/75mg
Strength
Ethambutol HCl…………300mg
Rifampicin………………150mg
Isoniazid…………………75mg
04-03-2019
Type of form Form 5
Approval status of product in Reference Rifampicin/Isoniazid/Ethambutol hydrochloride
Regulatory Authorities 150mg/75mg/275mg film coated Tablets (WHO Approved
formulation)
Me-too-status Myrin Tablets by M/s Pfizer Pakistan Ltd (Reg#009968)

deposite slip No. 2037972 date 28-08-2020. The revised
Ethambutol HCl…………300mg
Rifampicin………………150mg
Isoniazid…………………75mg
 However the firm did not corrected the strength in case of
Ethambutol HCl in label claim as per reference
formulation.
Brand Name + Dosage Form and Pirazin Tablet 500mg
Strength
Pyrazinamide………………500mg
04-03-2019
Pharmacological Group Other drugs for treatment of tuberculosis
Type of form Form 5
Approval status of product in Reference Pyrazinamide 500 mg uncoated Tablets (WHO Approved
Regulatory Authorities formulation)
Me-too-status PZ tablets 500mg by M/s Bio-Mark Pharmaceuticals
(Reg#093976)
Brand Name + Dosage Form and Lederrif INH 150 Tablet
Strength
Rifampicin…………150mg
Isoniazid……………75mg
04-03-2019
Type of form Form 5
Approval status of product in Reference Rifampicin/Isoniazid 150mg/75mg film-coated Tablets
Regulatory Authorities (WHO Approved formulation)
Me-too-status Rin 150mg/75mg Tablet by M/s Wyeth Pakistan Ltd (Reg.
No. 073790)
deposit slip No. 2037973 date 28-08-2020. The revised
Rifampicin…………150mg
Isoniazid……………75mg
The master formulation is submitted of different strength
594. Name and address of manufacture / Applicant M/s. Cirin Pharmaceuticals (Pvt) Ltd, 32/2A, Phase III,
Industrial Estate Hattar.
Brand Name + Dosage Form and Strength Etipro Capsule 40mg
Omeprazole (as enteric coated pellets 8.5%
w/w)………………40mg
Source: Precise Chemipharma Pvt. Ltd India
Dairy No. date of R &I fee Dy.No 12423 dated 06-03-2019 Rs.100,000/- Dated
06-03-2019
Type of form Form 5
Approval status of product in Reference Losec 40 mg hard gastro-resistant capsules MHRA
Me-too-status Gosoft Capsule 40mg by M/s Bio-Mark
GMP Status Last GMP inspection was conducted on 07-05-2018
and conclusion of inspection was;
Overall the firm was operating under good level of
cGMP
 The reply is submitted by M/s ICI Pakistan Limited.
ICI House, 5 West Wharf, Karachi. The firm
informed that the management of firm changed from
Cirin Pharmaceuticals to ICI Pakistan Ltd and
attached letter No. f.3-42/92-Lic (Vol-III) (Pt) dated
18-02-2020 issued by secretary Central Licensing
Board.
 The firm submitted valid GMP certificate of supplier
of pellets Precise Chemipharma Pvt. Ltd India valid
upto 27-02-2022.
 The COA and submitted stability study data shows
omeprazole enteric coated pellets 8.5% w/w while
the list of products attached with GMP certificate
doesnot contain omeprazole enteric coated pellets.

 The firm submitted stability study data of three
batches from the supplier of pellets as per
Requirements of Registration Board decision of
293rd meeting but not as per Zone IV-A.
595. Name and address of manufacture / Applicant M/s Sapient Pharma
123/S, Quaid e Azam Industrial Estate, Kot Lakhpat,
Lahore
Brand Name + Dosage Form and Strength Olmem 5mg/40mg Tablet

Amlodipine as Besylate……………...5mg
Olmesartan Medoxomil……………….40mg
04-03-2019
blockers (ARBs)
Type of form Form 5
Finished product specifications Innovator’s specification
Approval status of product in Reference Azor (5mg /20mg, 10mg /20mg, 5mg /40mg, 10mg
Regulatory Authorities /40mg) film coated tablets of (USFDA Approved)
Me-too-status Olesta-AM 5mg /40mg of M/s Searle Pakistan
(Reg#076188)
GMP Status GMP certificate issued to M/s Sapient Pharma Lahore
base on inspection conducted on 18-11-2019
 Firm submitted all documents as required in
enclosure of form 5.
Lahore
Brand Name + Dosage Form and Strength Olmem 5/20mg Tablet
Amlodipine as Besylate…………..…5mg
Olmesartan Medoxomil……………..20mg
Dated 04-03-2019
blockers (ARBs)
Type of form Form 5
Me-too-status Olesta-AM 5/20mg of M/s Searle Pakistan
(Reg#076187)
base on inspection conducted on 18-11-2019.
Remark of the Evaluator XI  Firm submitted all documents as required in
Lahore
Brand Name + Dosage Form and Strength Olmem 10/20mg Tablet

Amlodipine as Besylate………………10mg
Olmesartan Medoxomil…………….…20mg
Dated 04-03-2019
blockers (ARBs)
Type of form Form 5
Me-too-status Olesta-AM 10/20mg by M/s Searle Pakistan
(Reg#076189)
Remark of the Evaluator XI  Firm submitted all documents as required in
Lahore
Brand Name + Dosage Form and Strength Smval 5/80mg Tablets
Amlodipine besylate……..…5mg
Valsartan…………….…80mg
Dated 04-03-2019
blockers (ARBs)
Type of form Form 5
(Reg.#081931)
Remark of the Evaluator XI  The firm revise the label claim from uncoated to film
coated tablets along with submission of Rs. 5000/-
on deposite slip No. 0766456 date 02-09-2020. The
firm also corrected the salt form of amlodipine in
label claim as per reference formulation without
considering the salt factor. The revised label claim is
as under:
Amlodipine (as besylate) ……..…5mg
Lahore
Brand Name + Dosage Form and Strength Smval 5/160mg Tablets

Amlodipine besylate………5mg
Valsartan……………….160mg
Dated 04-03-2019
blockers (ARBs)
Type of form Form 5
(Reg.#081932)
Remark of the Evaluator XI  The firm revise the label claim from uncoated to film
coated tablets along with submission of Rs. 5000/-
on deposite slip No. 0766489 date 02-09-2020. The
firm also corrected the salt form of amlodipine in
label claim as per reference formulation without
considering the salt factor. The revised label claim is
as under:
Amlodipine (as besylate) ………5mg
600. Name and address of manufacture / Applicant M/s Athan Pharmaceuticals Plot 84/1, Block B, Phase
5, Industrial Estate Hattar.
Contract Manufactured by: M/s Aulton
Pharmaceuticals. Plot No. 84/1, Block A, Phase V,
Industrial Estate, Hattar, K.P.K
Brand Name + Dosage Form and Strength Cefial Capsule 400mg

Cefixime monohydrate eq to Cefixime…400mg
Dated 07-03-2019
Type of form Form 5
Approval status of product in Reference SUPRAX capsules 400mg, (USFDA approved)
Me-too-status Xalfocin 400mg Capsule by Martin Dow Karachi
(Reg. 80646)
GMP Status Issuance of DML to M/s Athan Pharmaceuticals
Hattarin 269th Meeting of CLB dated 05-03-2019.
Last GMP inspection of M/s Aulton Pharmaceuticals
Hattar was conducted on 27-06-2019 and conclusion of
inspection was:
As per observations made during inspection, the
manufacturing, quality control and environmental
facilities, provided the qualified staff employed, the
documentation maintained, implementation of the

SOP’s the GMP compliance status of the firm M/s
Aulton Pharma is found to be satisfactory.
Remark of the Evaluator XI  The firm submitted letter No. F. 1-17/2013-Lic dated
11th April 2017 issued by Secretary Central Licensig
Board showing that M/s Aulton Pharmaceuticals
have Capsule section (Cephalosporin), Dry Powder
Suspension Section (Cephalosporin) and Dry Powder
Injection Section (Cephalosporin)
 Fee of Rs. 50,000/- submitted by manufacturer M/s
Aulton Pharmaceuticals and not the applicant M/s
Athan Pharmaceuticals. The firm informed that it
was clerical mistake to deposit the fee on deposit slip
of M/s Aulton Pharmaceuticals and they requested to
consider it on account of M/s Athan Pharmaceuticals.
 A copy of contract manufacturing agreement
between M/s Athan Pharmaceuticals and M/s Aulton
Pharmaceuticals is submitted
applicant. i.e. M/s Athan Pharmaceuticals
 The firm submitted list of 05 applied products for
contract manufacturing
5, Industrial Estate Hattar
Brand Name + Dosage Form and Strength Cefial 100mg/5ml Dry Suspension
Cefixime Trihydrate eq to Cefixime………100mg
Dated 07-03-2019
Type of form Form 5
Approval status of product in Reference Cefixime 100mg/5ml Powder for Oral Suspension
Me-too-status Fix 100mg/5ml Suspension by M/s Aptcure (Pvt) Ltd
(Reg. 85229)
inspection was:

 Fee of Rs. 50000/- submitted by manufacturer M/s
Brand Name + Dosage Form and Strength Cefixon 1g Injection IV
Ceftriaxone Sodium eq to Ceftriaxone….…1g
Dated 07-03-2019
Type of form Form 5
Approval status of product in Reference Rocephin 1g Powder for solution for injection or
Regulatory Authorities infusion MHRA Approved
Me-too-status Ceftro Injection 1gm IV by Biocef (Pvt) Ltd, (Reg.
No. 82740)
inspection was:
 The firm submitted letter No. F. 1-17/2013-Lic dated
 The firm submitted duly filled form 5 signed by the
signatory and undertaking at the end of form 5 signed

However, the deposit slip contains both the name of
M/s Aulton Pharmaceutical and its DML No.
000828.
 The firm did not mentioned type of primary
packaging material of applied formulation whether it
is type I, II or III glass container.
Brand Name + Dosage Form and Strength Cefixon 500mg injection IV

Ceftriaxone Sodium eq to Ceftriaxone…500mg
Dated 07-03-2019
Type of form Form 5
Approval status of product in Reference Ceftriaxone 500mg powder for solution for injection
Me-too-status Ceftro Injection 500mg IV by Biocef (Pvt) Ltd, (Reg.
No. 82738)
inspection was:

 Fee of Rs. 50000/- submitted by manufacturer M/s
However the deposit slip contain both the name of
000828.
is type I, II or III glass container
Brand Name + Dosage Form and Strength Cefixon 250mg injection IV
Dated 07-03-2019
Type of form Form 5
Approval status of product in Reference Rocephin 250mg Powder for solution for injection
Me-too-status Ceftro Injection 250mg IV by Biocef (Pvt) Ltd, (Reg.
No. 82737)
inspection was:

However the deposit slip contain both the name of
000828.
is type I, II or III glass container
 The firm did not submit master formulation for the
applied product.
605. Name and address of manufacture / M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207.
Applicant Industrial Triangle, Kahuta Road, Islamabad
Contract Manufactured By: M/s English
Pharmaceuticals Industries. Link Kattar Bund Road,
Thokar Niaz Baig, Multan Road, Lahore
Brand Name + Dosage Form and Strength Pipetazo 4.5g Injection
Piperacillin (as Sodium)…………..4g
Tazobactam (as Sodium)…………..0.5g
Dated 06-03-2019
Type of form Form 5
Me-too-status Tacip 4.5gm Injection by M/s Macter Int.
(Reg#73632)
GMP Status M/s Rotex Pharma Islamabad was inspected on 19-09-
2018 and recommendations of inspection was:
Keeping in view the above facts on record, the panel
unanimously recommends the approval of various
sections to M/s Rotex. The panel did not recommend the

Gel preparations/products in Cream/Ointment (Gen)
and Topical (Steroid) sections since the firm did not
possess required machinery and equipments for said
purpose.
Certificate of GMP Issued to English Pharmaceuticals
on 16-01-2018.
 Form 5 submitted by the applicant i.e. M/s Rotex
Pharma Pvt Ltd. along with undertaking at the end of
form 5.
M/s Rotex Pharma Pvt Ltd and M/s English
Pharmaceuticals Industries is submitted
applicant. i.e. M/s Rotex Pharma Pvt Ltd.
 The firm mentioned the use of type II glass container
as primary packaging material of applied formulation
606. Name and address of manufacture / M/s Rotex Pharma Pvt Ltd. Plot No. 206 & 207.
Applicant Industrial Triangle, Kahuta Road, Islamabad
Contract Manufactured By: M/s English
Pharmaceuticals Industries. Link Kattar Bund Road,
Thokar Niaz Baig, Multan Road, Lahore
Brand Name + Dosage Form and Strength Pipetazo 2.25g Injection
Piperacillin (as Sodium)…..……..2g
Tazobactam (as Sodium)………0.25g
Dated 06-03-2019
Type of form Form 5
Me-too-status Tanzo Injection by M/s Bosch Pharmaceutical (Reg.
No. 39593)
GMP Status M/s Rotex Pharma Islamabad was inspected on 19-09-
2018 and recommendations of inspection was:
unanimously recommends the approval of various
sections to M/s Rotex. The panel did not recommend the
Gel preparations/products in Cream/Ointment (Gen)
and Topical (Steroid) sections since the firm did not
possess required machinery and equipments for said
purpose.
Certificate of GMP Issued to English Pharmaceuticals
on 16-01-2018.
 Form 5 submitted by the applicant i.e. M/s Rotex
Pharma Pvt Ltd. along with undertaking at the end of
form 5.
M/s Rotex Pharma Pvt Ltd and M/s English
Pharmaceuticals Industries is submitted

applicant. i.e. M/s Rotex Pharma Pvt Ltd.
 The firm mentioned the use of type I glass container
as primary packaging material of applied formulation
Deferred cases (Human):

607. Name and address of manufacture / M/s Polyfine Chempharma.
Applicant 51-Industrial Estate, Hayatabad Peshawar, Pakistan
Brand Name + Dosage Form and Strength Falcon 120mg powder for Injection
Artesunate ..……120mg
05-12-2018
Type of form Form-5
Approval status of product in Reference WHO approved injectable artesunate 120mg (WHO
Regulatory Authorities Approved formulation)
Me-too-status Gen-M 120mg Injection of M/s Genix Pharma (Pvt)
Ltd. (Reg.#76073)
GMP Status The firm was inspected on 25.10.2018 wherein the
firm was considered to be operating at satisfactory
level of cGMP compliance.
Remark of the Evaluator XI  Firm submitted complete manufacturing outline
along with use of type I glass container as primary
packaging container
Previous Decision (295-DRB)  Deferred for confirmation of manufacturing facility
Evaluation by PEC  The firm submitted letter No.F.3-1/97-Lic (M-181)
dated 30th January 2004 confirming the approval of
injectable (powder) section
Decision: Approved.
608. Name and address of manufacture / M/s Polyfine Chempharma.
Applicant 51-Industrial Estate, Hayatabad Peshawar, Pakistan
Brand Name + Dosage Form and Strength Falcon 60mg powder for Injection
Artesunate ….…60mg
05-12-2018
Type of form Form-5
Approval status of product in Reference WHO approved injectable artesunate 60mg (WHO
Regulatory Authorities Approved formulation)
Me-too-status Misonate 60mg Injection of M/s Tabros Pharma (Pvt.)
Ltd. (Reg.# 57719)
GMP Status The firm was inspected on 25.10.2018 wherein the
firm was considered to be operating at satisfactory

Remark of the Evaluator XI  Firm submitted complete manufacturing outline
along with use of type I glass container as primary
packaging container
Previous Decision (295-DRB)  Deferred for confirmation of manufacturing facility
Evaluation by PEC  The firm submitted letter No.F.3-1/97-Lic (M-181)
dated 30th January 2004 confirming the approval of
injectable (powder) section
Decision: Approved.
609. Name and address of manufacture / M/s Semos Pharmaceuticals Pvt Ltd.
Applicant Plot No. 11, Sector 12-A, North Karachi, Krachi-
75850, Pakistan
Brand Name + Dosage Form and Strength Pyrol -T Plus 37.5/325mg Tablet
Tramadol…............37.5mg
Paracetamol……….325mg
30-11-2018
Pharmacological Group Opioids in combination with non-opioid analgesics
Type of form Form-5
Me-too-status Distalgesic Tablets by M/s Atco Lab., (Reg#73865)
report concludes that their current GMP compliance
level is rated as GOOD.
Remark of the Evaluator XI  The firm has submitted correct label claim as per
reference formulation without submission of
applicable fee. The correct label claim is;
Tramadol HCl ...…37.5mg
Paracetamol…..325mg
Moreover the firm adjusted the weight of API in
master formulation considering the salt factor.
 The firm submitted revised form 5 duly signed by
the qualified persons on the undertaking
Previous Decision (295-DRB)  Deferred for submission of applicable fee for
correction of label claim
Evaluation by PEC  The firm submitted Rs. 5000/- on deposite slip No.
2032819 dated 17-08-2020 for correction of label
claim
Decision: Approved.
610. Name and address of manufacture / M/s Jaens Pharmaceutical Industries Pvt Limited.
Applicant 28-km Lahore-Sheikhupura Road, Sheikhupura
Brand Name + Dosage Form and Strength Azal Eye Drops 1%
Azithromycin…..1% (10mg)
Dated 13-02-2019
Pharmacological Group Macrolide Antibiotic
Type of form Form 5
Approval status of product in Reference Azasite 1% sterile opthalmic solution USFDA

Me-too-status Kraze Opthalmic solution 10mg/ml by M/s
Meidcaids (Reg#082125)
GMP Status Firm was inspected on 20-12-2017 and Conclusion of
inspection was:
Based on the areas inspected, the people met and
considering the findings of inspection M/s Jaens
Pharmaceuticals (pvt.) ltd., is operating satisfactory.
Overall hygienic condition of the firm was
satisfactory at the time of inspection however, they
were advised to continue improvements in production
and quality control, they agreed.”
 Submit revised form 5 as per approved formate
(signatory alongwith some text is missing)
 You have not submit master formulation. Submit
complete master formulation
Previous Decision (295-DRB)  Deferred for submission of Form 5 as per approved
format along with master formulation.
Evaluation by PEC  The firm submitted revised form 5 as per
prescribed format along with master formulation of
the applied product
611. Name and address of manufacture / M/s Jaens Pharmaceutical Industries Pvt Limited.
Applicant 28-km Lahore-Sheikhupura Road, Sheikhupura
Brand Name + Dosage Form and Strength Hypersal Eye Drops 5%
Sodium chloride..…5%
Dated 13-02-2019
Pharmacological Group Other ophthalmologicals
Type of form Form 5
Pack size and Demand Price 5ml; 10ml; 15ml; As per SRO
Approval status of product in Reference OPTRINE FORET HYPERTONIC SALINE EYE
Regulatory Authorities DROPS sodium chloride 50mg/mL topical liquid
bottle (TGA Approved)
Me-too-status Sodium Chloride 5% Ophthalmic Solution by M/s
Opal Labs (Reg#48483)
GMP Status Firm was inspected on 20-12-2017 and Conclusion of
inspection was:
Based on the areas inspected, the people met and
considering the findings of inspection M/s Jaens
Pharmaceuticals (pvt.) ltd., is operating satisfactory.
Overall hygienic condition of the firm was
satisfactory at the time of inspection however, they
were advised to continue improvements in production
and quality control, they agreed.”
Remark of the Evaluator XI  The firm submitted revised form 5 but not as per
approved formate
 The firm submitted master formulation of the
applied
Previous Decision (295-DRB)  Deferred for submission of application on
prescribed Form 5.
Evaluation by PEC  The firm submitted revised form 5 as per
prescribed format
Decision: Approved.
612. Name and address of manufacture / M/s Aptcure Pvt Ltd; 8- Pharma City, 30 km Multan
Brand Name + Dosage Form and Strength Side 200mg Tablet
Amisulpride…..200mg
Dated 29-01-2019
Type of form Form 5
Approval status of product in Reference Amisulpride 200mg Tablets (MHRA Approved)
Me-too-status Amiride Tablet 200mg by M/s Shrooq
Pharmaceuticals (Pvt) Ltd (Reg#063102)
GMP Status The firm was inspected on 24-11-2017 for renewal of
DML and conclusion of inspection was:
In the light of inspection conducted by panel and based
on the findings, the panel of inspectors recommends
grant of renewal of drug manufacturing license by way
of formulation of M/s Aptcure (Pvt) Ltd., 30km Multan
Road Lahore for the following sections.
a) Tablet (General) Section
b) Capsule (General) Section
Remark of the Evaluator XI  The firm submitted the 1st page of form 5 duly signed
by the signatory.
Previous Decision (295-DRB)  Deferred for signatures as per requirement
Evaluation by PEC 
Decision: Approved.
Brand Name + Dosage Form and Strength Cavid 6.25mg Tablets
Carvedilol……6.25mg
Dairy No. date of R &I fee Dy.No 4104 dated 30-01-2019 Rs.20,000/- Dated 29-
01-2019
Pharmacological Group Alpha and beta blocking agents
Type of form Form 5
Approval status of product in Reference COREG 6.25 mg film-coated tablet USFDA
Me-too-status Hidilol 6.25mg Tablets by M/s Helix Pharma
(Reg#53014)
Remark of the Evaluator XI  The firm submitted 1st page of Form 5 duly signed
by the signatory.
Decision: Approved.

Carvedilol..…3.125mg
Dated 29-01-2019
Type of form Form 5
Approval status of product in Reference COREG 3.125mg film-coated tablet USFDA
Me-too-status Carlov 3.125mg Tablet by M/s Hilton Pharma
(Reg#36423)
by the signatory.
Decision: Approved.
Carvedilol…..12.5mg
Dated 29-01-2019
Type of form Form 5
Approval status of product in Reference COREG 12.5mg film-coated tablet USFDA Approved
Me-too-status Hidilol 12.5mg Tablets by M/s Helix Pharma
(Reg#50365)
by the signatory.
Decision: Approved.
Brand Name + Dosage Form and Strength Metfin 500mg Tablets
Metformin HCl…..500mg
Dairy No. date of R &I fee Dy.No 4120 dated 30-01-2019 Rs.20,000/- Dated 29-
01-2019
Pharmacological Group Biguanide (Antidiabetic)
Type of form Form 5
Approval status of product in Reference Metformin 500mg film coated Tablets (MHRA
Me-too-status Glucomin 500mg Tablet by M/s Lisko Pakistan
(Reg#82146)
by the signatory.
Decision: Approved.
Brand Name + Dosage Form and Strength Lagab Capsules 50mg
Pregabalin…………..50mg
Dated 29-01-2019
Type of form Form 5
Approval status of product in Reference Lyrica 50mg capsules USFDA approved
Me-too-status Gabica 50mg Capsule by M/s Getz Pharma
(Reg#48725)
by the signatory.

 Firm have applied for manufacturer’s specifications
and and the product is not present in available
pharmacopoeia (USP, BP, IP, JP).
Pregabalin………....100mg
Dated 29-01-2019
Type of form Form 5
Approval status of product in Reference LYRICA 100mg Capsules USFDA Approved
(Reg#47366)
by the signatory.
Pregabalin…..75mg
Dated 29-01-2019
Type of form Form 5
Approval status of product in Reference LYRICA 75mg Capsules USFDA Approved
(Reg#47365)
by the signatory.
Brand Name + Dosage Form and Strength Tamsin 0.4mg Capsule
Composition Each modified release Capsule Contains:
Tamsulosin HCl (as SR pellets 0.2%)..…0.4mg
(Source of Pellets: Vision Pharma)
Dated 29-01-2019
Pharmacological Group Alpha-adrenoreceptor antagonists
Type of form Form 5
Approval status of product in Reference Tamurex 400 micrograms prolonged-release capsules
Regulatory Authorities (MHRA approved)
Me-too-status Timsol 0.4 mg Capsule by M/s Scilife Pharma
(Reg#82094)
by the signatory.
 The firm submitted GMP Certificate of supplier of
pellets (Vision Pharma) which expired on
25.01.2019
Previous Decision (295-DRB)  Deferred for signatures as per requirement and
GMP Certificate of supplier of pellets (Vision
Pharma).
Evaluation by PEC  The firm submitted 1st page of Form 5 duly signed
by the signatory along with valid GMP certificate
of supplier of pellets (Vision Pharma) valid upto
10th February 2022.
Decision: Approved.
Brand Name + Dosage Form and Strength Zip 5mg Tablet
Zolmitriptan………………5mg

Dated 29-01-2019
Pharmacological Group Selective serotonin (5HT1) agonists
Type of form Form 5
Approval status of product in Reference Zolmitriptan 5mg film coated tablets MHRA
Me-too-status Zolmiton 5mg tablets of M/s CKD Pharmaceuticals
(Reg#081786)
by the signatory.
 The manufacturer have claimed manufacturer’s
specifications while the official monograph is
present in USP.
Decision: Approved.
Case no. 02 Registration applications for local manufacturing of (Veterinary) drugs

a. New cases
622. Name and address of manufacture / "M/s Elko Organization Pvt Ltd.
Applicant Plot No.27 & 28, Sector 12-B, North Karachi, Industrial
Area, Karachi"
Brand Name + Dosage Form and Coxnil E Oral Solution 500mg/ml
Strength
Amprolium..…500mg
Dated 11-02-2019
Pharmacological Group Anticoccidial Agent
Type of form Form 5
Pack size and Demand Price 500ml; 1L; 2.5L; Decontrolled
Me-too-status
GMP Status Routine GMP inspection conducted on 13-06-2017 & 06-
07-2017 concluded that the firm is operating at good level
of GMP compliance as of today.
Remark of the Evaluator XI  The firm replied that evidence of applied
formulation/drug already approved by DRAP is not
available but it is available internationally with name of
Amprolium 50% oral solution, “KEPRO”, Netherland
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.
Area, Karachi"

Brand Name + Dosage Form and Coxnil E Oral Solution 200mg/ml
Strength
Amprolium..…200mg
Dated 11-02-2019
Pharmacological Group Anticoccidial Agent
Type of form Form 5
Pack size and Demand Price 500ml; 1L; 2.5L; Decontrolled
Me-too-status Hi-Amprol Oral Solution by M/s Selmore
Remark of the Evaluator XI  The firm was asked for correction of label claim in
Form 5 from Each ml contains: Amprolium…200mg
to Each ml contains: Amprolium as HCl…200mg to
mention the salt form as per available label claim of
me-too product.
 The firm replied that they have mentioned Amprolium
as HCl…200mg in the label without submission of fee
and provide evidence of submitted label.
Area, Karachi"
Brand Name + Dosage Form and Doramax Injection 10mg/ml
Strength
Doramectin..……..…10mg
Dated 11-02-2019
Pharmacological Group Antiparasitic
Type of form Form 5
Pack size and Demand Price 100ml; Decontrolled
Me-too-status Dora Injection by M/s Wimits Pharmaceuticals
(Reg#088615)
Remark of the Evaluator XI  The firm inform that product will be terminally
sterilized after filling in the sterile area.
Area, Karachi"
Brand Name + Dosage Form and Elvomec Super Gold Injection 100ml pack
Strength
Ivermectin……………..20mg (2%)
Clorsulon………………..10mg (1%)
2019
Pharmacological Group Antiparasitic and anthelmintic
Type of form Form 5
Me-too-status Ivoclor Injection by M/S Nawal Pharmaceuticals
(Reg#078244)
Decision: Approved.
Area, Karachi"
Strength
Ivermectin…..20mg
Clorsulon…..10mg
Dated 21-02-2019
Type of form Form 5
(Reg#078244)
Decision: Approved.
Area, Karachi"
Strength
Ivermectin…..20mg
Clorsulon…..10mg
Dated 21-02-2019
Type of form Form 5
(Reg#078244)
Decision: Approved.
Area, Karachi"
Strength
Ivermectin…………...20mg
Clorsulon…………….10mg
2019
Type of form Form 5
(Reg#078244)
Decision: Approved.
629. Name and address of manufacture / M/s Inshal Pharmaceutical Industries.
Applicant Plot No. 2, Street SS 2, National Industrial Zone, Rawat,
Islamabad
Brand Name + Dosage Form and Ketox-T LA Injection
Strength
Oxytetracycline……..…200mg
Ketoprofen……………...30mg
Dated 11-02-2019
Pharmacological Group Antibiotic, NSAID
Type of form Form 5
Finished product specifications Manufacturer Specifications
Me-too-status Oxyfen LA Injection By M/s Selmore Pharmaceutical
(Reg#071091)
inspection was:
inspection areas visited, documents reviewed and people
met it is concluded that the firm M/s Inshal
Pharmaceutical Rawat has rectified majority of the
observations from the previous inspection in the firm was
found fit/suitable for manufacturing and testing of
pharmaceuticals products in all sections.
Remark of the Evaluator XI  The firm submitted incorrect undertaking at the end of
form 5
 The firm submitted the use of type II glass container as
Decision: Deferred for clarification of type of primary packaging material for applied
formulation and submission of correct undertaking.
630. Name and address of manufacture / M/s Univet Pharmaceuticals.
Applicant 14-km, Adyala Road, Post Office Dahgal, Rawalpindi
Brand Name + Dosage Form and Avilamix 10% Powder
Strength
Composition Each 100g contains:
Avilamycin…………10g

Dated 27-02-2019
Type of form Form 5
Pack size and Demand Price HDPE Jars 100g, 500g, 1kg, 2.5kg, 5kg, 10kg, 20kg,
25kg; As per SRO
Me-too-status
GMP Status The firm was inspected on 26/10/2017 and conclusion of
inspection was:
The firm is working at good level of GMP compliance as
of today
Remark of the Evaluator XI  The firm submitted undertaking at the end of form 5
duly signed by the technical persons
 Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) contains
different ingredients (Avilamycin Activity 100gms,
Soybean Mill Run 900gms) than applied product
(generic / me-too) alongwith registration number, brand name and name of firm.
b. Deferred cases (Veterinary):
631. Name and address of Manufacturer D-Haans Pharma (Pvt) Ltd. Plot No. 9/A, Industrial
/ Applicant Estate, Bhimber. AJK.
Brand Name, Dosage Form, Strength AMI-HANS ORAL LIQUID
Composition Each 100ml contains:-
Doxycycline HCl ………………… 20g
Tylosin tartrate ……………….…. 10g
Guaifenesin ….…………………. 20g
Aminophylline ………………… 8g
Diary No., Date of R & I & Fee Dy.No 1529 dated 14/02/2020; Rs. 20,000 14/02/2020
Pharmacological Group Antibiotic, Expectorant, Bronchodilator
Type Of Form Form 5
Finished product Specification Manufacturers Specification
Pack Size and Demanded Price 100ml, 150ml, 250ml, 500ml, 1Litre; Decontrolled
Me-Too Status Tyco-G Oral Liquid by M/s Attabak Pharmaceuticals
(Reg#075704)
GMP Status New DML (No. 000912) issued on 11-02-2020 on the
basis of inspection conducted on 12-12-2019.
Remarks of Evaluator  The firm has not revised the label claim as per approved
Mee-Too product alongwith submission of applicable fee.
The strength of molecules of the applied product is
different as compared to approved Mee-Too product.
 The firm has claimed manufacturer’s specifications and
the product is not present in available pharmacopoeia
(USP, BP, IP, JP)
Previous Decision (294-DRB)  Deferred for revision of formulation as per DRAP
approved me-too / generic product along with submission
of requisite fee.
Evaluation by PEC  The firm revised the formulation (corrected the strength
of molecule in label claim) as per DRAP approved me-
too / generic product along with submission of Rs
20,000/- on deposit slip No. 2028350 dated 24-08-2020.
The firm also submitted the requisite documents as per
Case no. 03 Registration applications for local manufacturing of (Human-Covid) drugs
a. New cases
Priority approval of Azithromycin:

In continuation to Authority‟s letter NO. F.76-DRAP/2020(PE&R) dated 5th May, 2020, Drug Regulatory
Authority of Pakistan in its 77th meeting held on 7th April, 2020 has also approved the formulation of
Azithromycin in the list of drugs/formulations for priority approval/registeration during COVID-19
pandemicalong with other drugs.
1.Azithromycin Tablet 500mg:

Composition: Each Film coated tablet contains: Azithromycin as dihydrate…….500mg
Availability in RRAs: Azithromycin 500mg Film-Coated Tablets MHRA Approved
Me too status: Azithrolide 500mg Tablet by M/s Heal Pharma (Reg # 084234)
Specifications: USP
Sr. Name of Brand Composition Diary no. / Date Pack Remarks/ Decision
No. applicant Name / fee / form Size / GMP
Price status
632. M/s Ameer Azomeer Each Film Form-5 Dy.No 3’s, The firm Approved.
Pharma. 23 KM- 500mg Coated Tablet 15112 dated 29- 6’s, was
Sheikhupura Tablet Contains: 06-2020 7’s, inspected
Road, Lahore Azithromycin Rs.20,000/- 10’s, on 9-12-
as Dated 29-06- 14’s, 2019 and
Dihydrate…. 2020 20’s, 26-01-2020
…500mg 28’s, and panel
30’s; recommend
As per s renewal of
SRO DML
633. M/s Metro Otisthro Each Film Form-5 Dy.No 6’s, Last Approved.
Pharmaceuticals. 500mg Coated Tablet 15804 dated 02- 12’s; inspection
Plot # 14, Street Tablet Contains: 07-2020 As per report dated
No. SS-2, Azithromycin Rs.20,000/- SRO 17/05/2019,
National Dihydrate Eq. Dated 02-07- and panel
Industrial Zone, to 2020 recommend
Rawat, Azithromycin s renewal of
Rawalpindi …500mg DML.
634. M/s Goodman Azithro Each Film Form-5 Dy.No 1x6’s, GMP Approved.
Laboratories. 500mg Coated Tablet 15177 dated 29- 1x3’s; certificate
No.5, Street No. Tablet Contains: 06-2020 As per issued on
S-5, National Azithromycin Rs.20,000/- SRO the basis of
Industrial Zone, (as Dihydrate) Dated 29-06- inspection
Rawat, ….…500mg 2020 conducted
Rawalpindi on
08/08/2018.
635. M/s Rasco Az-Ko Each Film Form-5 Dy.No 6’s; The firm Approved.
Pharma. 500mg Coated Tablet 15045 dated 26- As per was
5.5 Km, Raiwind Tablet Contains: 06-2020 SRO inspected
Road, Lahore Azithromycin Rs.20,000/- on 04-02-
(as Dated 26-06- 2019 and
Dihydrate)…5 2020 panel
00mg recommend
s renewal of
DML
636. M/s Shaheen Azidose Each Film Form-5 Dy.No 1x6’s, Last Approved.
Pharmaceuticals. 500mg Coated Tablet 14222 dated 19- 1x3’s; inspection
3 km, Murghzar Tablet Contains: 06-2020 As per report dated
Road,Saidu Sharif Rs.20,000/- SRO 18-10-2019
Azithromycin Dated 19-06- concluded
as 2020 that the
Dihydrate….. firm was
500mg considered
to be
operating at
satisfactory
level of
cGMP.
637. M/s Axis Hyzith Each Film Form-5 Dy.No 6’s; The firm Approved.
Pharmaceuticals. 500mg Coated Tablet 13951 dated 17- As per was
Value Addition Tablet Contains: 06-2020 SRO inspected
City, 3-B, 1.5km, Azithromycin Rs.20,000/- on 19.09.18
Khurrianwala- (as Dated 17-06- & 03.10.18,
Sahianwala Road, Dihydrate)… 2020 wherein the
Faisalabad …..500mg panel
recommend
s for grant
of cGMP
certificate
638. M/s Munawar M-Zith Each film Form-5 Dy.No 10’s; GMP Approved.
Pharma Pvt Ltd. 500mg coated Tablet 13956 dated 17- As per certificate
31 Km, Ferozepur Tablet Contains: 06-2020 SRO issued
Road, Lahore Azithromycin Rs.20,000/- based on
as Dated 17-06- inspection
Dihydrate..… 2020 dated 07-
500mg 11-2017
The firm
revised the
label claim
from
uncoated to
film coated
tablets
along with
submission
of Rs
5000/- on
deposit slip
No.202633
5 dated 31-
08-2020
639. M/s Mafins Azi-M Each Film Form-5 Dy.No 1x6’s; The firm Deferred
Pharma. 500mg Coated Tablet 14298 dated 22- As per was for
Plot No. A-5, Tablet Contains: 06-2020 SRO inspected clarificatio
S.I.T.E, Super Azithromycin Rs.20,000/- on 05-10- n of
Highway Dihydrate Eq. Dated 22-06- 2017 manufactu
Industrial Area, to 2020 representin ring
Karachi Azithromycin g good outline for
…500mg level of applied
GMP. formulatio
n.
You have
applied for
film coated
tablets but
master

formulation
and
manufacturi
ng outline
doesn’t
show
coating
compositio
n and
coating
procedure
respectively
, clarify?
640. M/s Lawari Azor 500mg Each film Form-5 Dy.No 1x6’s; The firm Deferred
International film coated coated Tablet 11426 dated 05- As per applied on for
Pharmaceuticals Tablet Contains: 03-2019 SRO prescribed revision of
Valley Road, Gul Azithromycin Rs.20,000/- form 5 for formulatio
KADU Saidu as Dated 05-03- the product n as per
Sharif Swat, KPK dihydrate.… 2019 along with reference
…500mg undertaking product.
at the end Submissio
of form 5. n of
The firm applicable
revised the fee, GMP
label claim status
from during last
uncoated to 3 years and
film coated justificatio
tablets n of using
without overage.
submission
of
applicable
fee.
Latest
GMP
inspection
report not
submitted
Justification
for addition
of 2%
overage
641. M/s Karsons Karzit-Forte Each Film Form-5 Dy.No 2’s, Firm was Approved.
Pharmaceuticals. 500mg tablet Coated Tablet 17876 dated 22- 3’s, inspected
Plot No.1, Street Contains: 07-2020 4’s, on 17-12-
No. SS-3, Azithromycin Rs.20,000/- 6’s, 2019 and
National (as Dated 22-07- 10x6’s conclusion
Industrial Zone, Dihydrate)…5 2020 10x3’s was: basic
Rawat, Islamabad 00mg 10’s, elements of
12’s; GMP
As per compliance
SRO reference to
schedule B-
II are in
place and
complied
with.

642. M/s Medisave Maczin Each Film Form-5 Dy.No 6’s; GMP Approved.
Pharmaceuticals. 500mg Coated Tablet 17871 dated 22- As per certificate
Plot 578-579, Tablet Contains: 07-2020 SRO issued to
Sundar Industrial Azithromycin Rs.20,000/- the firm
Estate, Lahore, Dihydrate Eq. Dated 22-07- based on
Pakistan to 2020 inspection
Azithromycin conducted
…500mg on 02-10-
2019
643. M/s Iqra Zito-Forte Each Film Form-5 Dy.No 2’s, New Approved.
Pharmaceuticals. 500mg Coated Tablet 17717 dated 21- 3’s, License
Plot No. 02, Tablet Contains: 07-2020 4’s, (inspection
Street No. S-9, Azithromycin Rs.20,000/- 6’s, dated 19-
National (as Dated 21-07- 10x6’s 02-2019 the
Industrial Zone, Dihydrate)… 2020 10x3’s panel
Rawat, …….500mg 10’s, unanimousl
Islamabad, 12’s; y
Pakistan As per recommend
SRO s the grant
of DML)
644. M/s Ameer & Zocin Each Film Form-5 Dy.No 6’s, The firm Approved.
Adnan 500mg Coated Tablet 18315 dated 27- 10’s; was
Pharmaceutical Tablet Contains: 07-2020 As per inspected
Pvt Ltd. Azithromycin Rs.20,000/- SRO on 07-11-
Plot No.47, as Dated 27-07- 2019 and
Sundar Industrial Dihydrate…5 2020 conclusion
Estate, Lahore 00mg of
inspection
was that the
firm was
operating at
satisfactory
level of
cGMP
compliant
on the day
of
inspection
645. M/s Karachi Kpazith Each Film Form-5 Dy.No 1x6’s; The firm Approved.
Pharmaceutical 500mg Coated Tablet 18322 dated 27- As per was
Laboratories. Tablet Contains: 07-2020 SRO inspected
Plot No. S/54, Azithromycin Rs.20,000/- on 16-10-
Hawkes Bay Dihydrate Eq. Dated 27-07- 2018
Road, S.I.T.E., to 2020 wherein the
Karachi, Pakistan Azithromycin panel
…500mg recommend
ed the
renewal of
DML
646. M/s Biogen Azogen Each Film Form-5 Dy.No 6’s; The firm Approved.
8-Km, Chakbeli Tablet Contains: 07-2020 SRO inspected
Road, Rawat, Azithromycin Rs.20,000/- on 12-12-
Rawalpindi, as Dated 29-07- 2019 and
Pakistan Dihydrate… 2020 the panel
…500mg unanimousl
y
recommend
ed the grant
of DML
647. M/s Standard Fluzicin Each Tablet Form-5 Dy.No As per Form 5 not Deferred
Drug Company. 500mg Contains: 18765 dated 30- SRO submitted for
Plot No 07-A, Tablet Azithromycin 07-2020 The submission
S.I.T.E Area, Dihydrate Eq. Rs.20,000/- reference of Form 5,
Karachi to Dated 29-07- formulation revision of
Azithromycin 2020 is film formulatio
…500mg coated n and
while you manufactu
have ring
applied for outline
uncoated alongwith
tablet. applicable
Revise the fee.
label claim,
master
formulation
and
manufacturi
ng outline
along with
submission
of
applicable
fee.
Latest GMP
inspection
report
648. M/s Parkar Azikar Each Tablet Form-5 Dy.No As per The firm Deferred
Pharma. 500mg Contains: 18763 dated 30- SRO was for
Plot No. O/7-A, Tablet Azithromycin 07-2020 inspected revision of
S.I.T.E Area Dihydrate Eq. Rs.20,000/- on 07-02- formulatio
Kotri, Sindh to Dated 29-07- 2018 and n and
Azithromycin 2020 Panel manufactu
…500mg recommend ring
s the grant outline
of DML. alongwith
Revise the applicable
1st page of fee.
form 5 as
per
prescribed
format.
The
reference
formulation
is film
coated
while you
have
applied for
uncoated
tablet.
Revise the
label claim,
master
formulation

and
manufacturi
ng outline
along with
submission
of
applicable
fee.
649. Deleted.
650. M/s Quaper Z-Max Each film Form-5 Dy.No 1x6’s; The firm is Approved.
Pharmaceuticals 500mg coated Tablet 18778 dated 30- As per granted
Plant 26-A Small Tablet Contains: 07-2020 SRO GMP
Industrial Estate Azithromycin Rs.20,000/- certificate
Lahore Road, Dihydrate Eq. Dated 30-07- based on
Sargodha to 2020 inspection
Azithromycin dated 28-
…500mg 01-2019.
651. M/s Shazal's Azimal Each film Form-5 Dy.No 6’s; The firm Approved.
Pharmaceuticals. 500mg coated Tablet 18775 dated 30- As per was
Plot No.41/1-A, Tablet Contains: 07-2020 SRO inspected
Phase-I, Industrial Azithromycin Rs.20,000/- on 13-02-
Estate, Hattar (as Dated 30-07- 2019 and
dihydrate).…5 2020 09-01-2020
00mg and the
panel
unanimousl
y
recommend
s
resumption
of
production
activities in
all sections
of the firm.
652. M/s Harmann Zithrobbas Each film Form 5 Dy.No. 1x6’s; Decision of Approved.
Pharmaceutical 500mg coated Tablet 9125 dated As per 272st
Laboratories Pvt Tablet Contains: 28/04/2020 Rs. SRO Meeting of
Limited, 16-Km Azithromycin 20,000/- dated CLB dated
Multan Road, as 28-04-2020 13-11-
Lahore dihydrate.…5 2019:
00mg I- Allow
resumption
of
production
activities in
all sections
except
Sterile
Liquid
Section of
the firm M/s
Harmann
Laboratorie
s Lahore in
as per
recommend
ation of
panel
inspection
report dated
09-10-2019
in following
sections.
a- Sterile
Section-I
(General
Injection)
b- Sterile
Section-III
(Hormonal
Injection)
II-
Regularize
the layout
plan of
Hormonal
Section, as
per
recommend
ations of
the panel in
the reort
dated 13-
06-2019 &
08-10-2019.
653. M/s Welmark Ezimark Each Film Form 5 Dy.No. As per Last GMP Approved.
Pharmaceuticals. 500mg coated Tablet 15441 dated SRO inspection
Plot #122 Phase Tablet Contains: 30/06/2020 Rs. dated 04-
5, Block B, Azithromycin 20,000/- dated 09-2018 &
Industrial Hattar as 30-06-2020 26-09-2018
Dihydrate..… and panel
500mg unanimousl
y
recommend
s the
renewal of
DML
000614 by
way of
formulation
granted to
M/s
Welmark
KPK.
Undertakin
g at the end
of form 5 is
missing
2.Azithromycin Tablet 250mg:

Composition: Each Film coated tablet contains: Azithromycin as dihydrate…….250mg
Availability in RRAs: Azithromycin 250mg Film-Coated Tablets MHRA Approved
ME too status: Azithrolide 250mg tablet of M/s Heal Pharma (Reg. # 084233)
Specifications: USP
Sr. Name of Brand Composition Diary no. / Date / Pack Remarks/ Decision

No. applicant Name fee / form Size / GMP
Price status
654. M/s Ameer Azomeer Each Film Form-5 Dy.No 3’s, The firm Approved.
Pharma. 23 KM- 250mg Coated Tablet 15118 dated 29- 6’s, was
Sheikhupura Tablet Contains: 06-2020 7’s, inspected
Road, Lahore Azithromycin Rs.20,000/- Dated 10’s, on 9-12-
as 29-06-2020 14’s, 2019 and
Dihydrate…2 20’s, 26-01-2020
50mg 28’s, and panel
30’s; recommend
As per s renewal of
SRO DML
655. M/s Metro Otisthro Each Film Form-5 Dy.No 2’s, Last Approved.
Pharmaceuticals. 250mg Coated Tablet 15805 dated 02- 4’s, inspection
Plot # 14, Street Tablet Contains: 07-2020 6’s, report dated
No. SS-2, Azithromycin Rs.20,000/- Dated 10’s, 22/05/2018,
National Dihydrate Eq. 02-07-2020 12’s; the firm is
Industrial Zone, to As per operating
Rawat, Azithromycin SRO with cGMP
Rawalpindi …250mg as of today.
656. M/s Linz Azax Each Film Form-5 Dy.No 6’s, Inspection Approved.
Pharmaceuticals 250mg Coated Tablet 16165 dated 07- 10’s; date
Pvt Ltd, Plot No Tablet Contains: 07-2020 As per 09/01/2020,
31-G & 31-H, Azithromycin Rs.20,000/- Dated SRO GMP of the
Sector 15 Korangi Dihydrate Eq. 06-07-2020 firm is rated
Induatrial Area to as
Karachi Azithromycin Good.
…250mg
657. M/s Bosch Zezot Each Film Form-5 Dy.No 6’s, Inspection Approved.
Pharmaceuticals 250mg Coated Tablet 16170 dated 07- 10’s; dated
Pvt Ltd. Tablet Contains: 07-2020 As per 17/09/2019,
Bosch House 221, Azithromycin Rs.20,000/- Dated SRO Acceptable
222, & 223, Dihydrate Eq. 06-07-2020 level of
Sector 23, to GMP
Korangi Azithromycin compliance.
Industrial Area, …250mg
Karachi, Pakistan
658. M/s Munawar M-Zith Each film Form-5 Dy.No 6’ GMP Approved.
Pharma Pvt Ltd. 250mg Coated Tablet 13955 dated 17- 10’s; certificate
31 Km, Ferozepur Tablet Contains: 06-2020 As per issued
Road, Lahore Azithromycin Rs.20,000/- Dated SRO based on
as 17-06-2020 inspection
Dihydrate… dated 07-
….250mg 11-2017
The firm
revised the
label claim
from
uncoated to
film coated
tablets
along with
submission
of Rs
5000/- on
deposit slip
No.202633
4 dated 31-
08-2020
659. M/s Lawari Azor Each film Form-5 Dy.No 1x10’s The firm Deferred
International 250mg coated Tablet 11427 dated 05- As per applied on for
Pharmaceuticals film coated Contains: 03-2019 SRO prescribed submissioin
Valley Road, Gul Tablet Azithromycin Rs.20,000/- Dated form 5 for of
KADU Saidu as dihydrate 05-03-2019 the product justification
Sharif Swat, KPK …250mg along with for addition
undertaking of 2%
at the end overage,
of form 5. GMP
The firm status, fee
revised the for revision
label claim of
from formulation
uncoated to
film coated
tablets
without
submission
of
applicable
fee.
Latest
GMP
inspection
report not
submitted
Justification
for addition
of 2%
overage
660. M/s Karsons Karzit Each Film Form-5 Dy.No 2’s, Firm was Approved.
Pharmaceuticals. 250mg Coated Tablet 17875 dated 22- 3’s, inspected
Plot No.1, Street tablet Contains: 07-2020 4’s, on 17-12-
No. SS-3, Azithromycin Rs.20,000/- Dated 6’s, 2019 and
National (as Dihydrate) 22-07-2020 10x6’s conclusion
Industrial Zone, …250mg 10x3’s was: basic
Rawat, Islamabad 10’s, elements of
12’s; GMP
As per compliance
SRO reference to
schedule B-
II are in
place and
complied
with.
661. M/s Iqra Zito Each Film Form-5 Dy.No 2’s, New Approved.
Pharmaceuticals. 250mg Coated Tablet 17718 dated 21- 3’s, License
Plot No. 02, Tablet Contains: 07-2020 4’s, (inspection
Street No. S-9, Azithromycin Rs.20,000/- Dated 6’s, dated 19-
National (as 21-07-2020 10x6’s 02-2019 the
Industrial Zone, Dihydrate)… 10x3’s panel
Rawat, 250mg 10’s, unanimousl
Islamabad, 12’s; y
Pakistan recommend

As per s the grant
SRO of DML)
662. M/s Ameer & Zocin Each Film Form-5 Dy.No 6’s, The firm Approved.
Adnan 250mg Coated Tablet 18340 dated 27- 10’s; was
Pharmaceutical Tablet Contains: 07-2020 As per inspected
Pvt Ltd. Azithromycin Rs.20,000/- Dated SRO on 07-11-
Plot No.47, as 27-07-2020 2019 and
Sundar Industrial Dihydrate…2 conclusion
Estate, Lahore 50mg of
inspection
was that the
firm was
operating at
satisfactory
level of
cGMP
compliant
on the day
of
inspection
663. M/s Karachi Kpazith Each Film Form-5 Dy.No 1x6’s; The firm Approved.
Pharmaceutical 250mg Coated Tablet 18321 dated 27- As per was
Laboratories. Tablet Contains: 07-2020 SRO inspected
Plot No. S/54, Azithromycin Rs.20,000/- Dated on 16-10-
Hawkes Bay Dihydrate Eq. 27-07-2020 2018
Road, S.I.T.E., to wherein the
Karachi, Pakistan Azithromycin panel
…250mg recommend
ed the
renewal of
DML
664. M/s Biogen Azogen Each Film Form-5 Dy.No 6’s; The firm Approved.
8-Km, Chakbeli Tablet Contains: 07-2020 SRO inspected
Road, Rawat, Azithromycin Rs.20,000/- Dated on 12-12-
Rawalpindi, as 29-07-2020 2019 and
Pakistan Dihydrate…2 the panel
50mg unanimousl
y
recommend
ed the grant
of DML
665. Deleted.
666. AAA Health Aizomax Each Film Form 5 Dy.No. 3’s, The firm Approved.
Pharmaceuticals 250mg Coated Tablet 11684 dated 6’s; was
Laboratories. Tablet Contains: 20/05/2020 Rs. As per inspected
Plot# 9A, Street # Aizthromycin 20,000/- dated 20- SRO on 09-10-
N-5, National as 05-2020 2019 and
Industrial Zone, Dihydrate… conclusion
Rawat, Islamabad …250mg of
inspection
was:
The
inspection
concluded
and firm
request
acceded to
complete
the work
and appoint
technical
staff as
required
under law
along with
instruments
repair work.
Form 5 has
not been
signed by
signatory
667. M/s Welwink Winkthro Each Film Form 5 Dy.No. As per Last GMP Approved.
Pharmaceuticals. 250mg coated Tablet 12599 dated SRO inspection
Factory G.T. Tablet Contains: 04/06/2020 Rs. conducted
Road, Industrial Azithromycin 20,000/- dated 03- on 20-12-
Estate, as 06-2020 2017 and
Gujranwala Cantt. Dihydrate… report
……250mg concludes
that the
panel
concluded
that the
firm was
operating at
satisfactory
level of
GMP
compliance
for all
sections
except
liquid
injectable
section for
which the
firm was
advised to
provide
liquid
particle
counter and
TOC at
earliest.
3.Azithromycin powder for oral suspension 200mg/5ml:

Composition:
Each 5ml reconstituted suspension Contains:
Azithromycin monohydrate eq to Azithromycin…200mg
Availability in RRAs: Azithromycin 200mg/5ml powder for oral suspension MHRA Approved.
Me-too status:
Palthro Dry Suspension 200mg/5ml by M/s Palpex Pharmaceuticals (Reg. No. 082947)
Specifications: USP

Sr. Name of Brand Composition Diary no. / Pack Remarks/ Decision
No. applicant Name Date / fee / Size / GMP
form Price status
668. M/s Epoch Azicin Dry Each 5ml Form-5 Dy.No 60ml, Last GKP Deferred
Pharmaceuticals. Powder prepared 11412 dated 05- 30ml; inspection for updated
Plot # 83-85, Suspension suspension 03-2019 As per of the firm GMP status
Sector 15, 200mg/5ml contains: Rs.20,000/- SRO was
Korangi 204.8mg Dated 05-03- conducted
Industrial Area, Azithromycin 2019 on 26-02-
Karachi monohydrate 2019 and
eq to 200mg concluded
azithromycin satisfactory
…200mg/5ml level of
GMP
compliance
669. M/s Karachi Kpazith Each 5ml Form-5 Dy.No 15ml; The firm Deferred
Pharmaceutical 200mg/5ml Contains: 18320 dated 27- As per was for
Laboratories. Dry Powder Azithromycin 07-2020 SRO inspected confirmatio
Plot No. S/54, Suspension monohydrateE Rs.20,000/- on 16-10- n of
Hawkes Bay q. to Dated 27-07- 2018 required
Road, S.I.T.E., Azithromycin 2020 wherein the manufactur
Karachi, Pakistan …200mg panel ing facility
recommend for applied
ed the formulation
renewal of .
DML
Firm
submitted
renewal
inspection
report
showing
dry powder
suspension
(cephalospo
rin) section
and doesnot
have dry
powder
suspension
(general)
section
4.Azithromycin for suspension 100mg/5ml:

Composition:
Each 5ml reconstituted suspension Contains:
Azithromycin as dihydrate…………..…100mg
Availability in RRAs: ZITHROMAX (100mg/5ml) for oral suspension USFDA Approved.
Me-too status: Azitma 100mg/5ml dry suspension of M/s Sami Karachi. (Reg.# 074901)
Specifications: USP
Price status
670. M/s Bosch Zezot Each 5ml Form-5 Dy.No 15ml, Inspection Approved.
Pharmaceuticals 100mg/5ml Contains: 16169 dated 07- 30ml, dated
Pvt Ltd. Suspension 07-2020 60ml; 17/09/2019,
Bosch House 221, Azithromycin Rs.20,000/- As per Acceptable
222, & 223, Dihydrate Eq. Dated 06-07- SRO level of
Sector 23, to 2020 GMP
Korangi Azithromycin compliance.
Industrial Area, …100mg
Karachi, Pakistan
671. M/s Karachi Kpazith Each 5ml Form-5 Dy.No 15ml; The firm Deferred
Pharmaceutical 100mg/5ml Contains: 18319 dated 27- As per was for
Laboratories. Dry Powder Azithromycin 07-2020 SRO inspected confirmati
Plot No. S/54, Suspension dihydrate Eq. Rs.20,000/- on 16-10- on of
Hawkes Bay to Dated 27-07- 2018 required
Road, S.I.T.E., Azithromycin 2020 wherein the manufactu
Karachi, Pakistan …100mg panel ring
recommend facility for
ed the applied
renewal of formulatio
DML n.
Firm
submitted
renewal
inspection
report
showing
dry powder
suspension
(cephalospo
rin) section
and doesnot
have dry
powder
suspension
(general)
section
672. M/s Linz Azax Each 5ml Form-5 Dy.No 15ml, Inspection Approved.
Pharmaceuticals 100mg/5ml Contains: 16164 dated 07- 30ml, of Bosch
Pvt Ltd Suspension Azithromycin 07-2020 60ml; Pharma
Plot No 31-G & Dihydrate Eq. Rs.50,000/- As per dated
31-H, Sector 15 to Dated 06-07- SRO 17/09/2019,
Korangi Azithromycin 2020 Acceptable
Induatrial Area …100mg level of
Karachi GMP
Contract compliance.
manufactured The firm
By: submitted
M/s Bosch contract
Pharmaceuticals manufacturi
Pvt Ltd. ng
Bosch House 221, agreement
222, & 223, between
Sector 23, M/s Linz
Korangi Pharmaceut
Industrial Area, icals and
Karachi, Pakistan M/s Bosch
Pharmaceut
icals
The firm
submited
list of 4

approved
sections
The firm
did not
submit list
of products
already
registered/a
pproved on
contract
manufacturi
ng in the
name of
applicant
The firm
submitted
list of 07
applied
products
for
contract
manufactu
ring.
5.Azithromycin capsule 250mg:

Composition: Each Capsule Contains:
Azithromycin Dihydrate eq to Azithromycin………………………...……250mg
Availability in RRAs: Azithromycin 250mg capsules MHRA Approved
ME too status: Zidor Capsule 250mg of M/s Winthrox Karachi. (Reg.# 074943)
Specifications: USP
Note: Amperometer electrochemical with dual glassy carbon electrodes is required as per available
monograph of USP 42.
form Price status
673. M/s Lawari Cazithro Each Capsule Form-5 Dy.No 6’s; The firm Deferred
International 250mg Contains: 11430 dated 05- As per applied on for updated
Pharmaceuticals Capsule Azithromycin 03-2019 SRO prescribed GMP status
Valley Road, Gul as dihydrate Rs.20,000/- form 5 for of the firm
KADU Saidu …250mg Dated 05-03- the product by QA &
Sharif Swat, KPK 2019 alongwith LT.
undertaking
at the end
of form 5
Latest
GMP
inspection
report is not
submitted
674. M/s Biogen Bio-Az Each Hard Form-5 Dy.No 6’s; The firm Deferred
Pharma. 250mg Gelatin 18687 dated 29- As per was for
8-Km, Chakbeli Capsule Capsule 07-2020 SRO inspected completion
Road, Rawat, Contains: Rs.20,000/- on 12-12- of Form 5.
Rawalpindi, Azithromycin Dated 29-07- 2019 and
Pakistan as 2020 the panel
unanimousl

Dihydrate…2 y
50mg recommend
ed the grant
of DML
Undertakin
g at the end
of form5
submitted
without
signature
675. M/s Standard Fluzicin Each Capsule Form-5 Dy.No As per Revise the Deferred
Drug Company. 250mg Contains: 18764 dated 30- SRO 1st page of for
Plot No 07-A, Capsule Azithromycin 07-2020 form 5 as correction
S.I.T.E Area, Dihydrate Eq. Rs.20,000/- per of Form 5
Karachi to Dated 29-07- prescribed and GMP
Azithromycin 2020 format. status.
…250mg Also form 5
submitted
without
signature of
applicant
Blistering
and packing
not
mentioned
in
manufacturi
ng outline.
Submit
complete
manufacturi
ng outline
Latest GMP
inspection
report
676. M/s Parkar Azikar Each Capsule Form-5 Dy.No As per The firm Deferred
Pharma. 250mg Contains: 18762 dated 30- SRO was for
Plot No. O/7-A, Capsule Azithromycin 07-2020 inspected correction
S.I.T.E Area Dihydrate Eq. Rs.20,000/- on 07-02- of Form 5.
Kotri, Sindh to Dated 29-07- 2018 and
Azithromycin 2020 Panel
…250mg recommend
s the grant
of DML.
Revise the
1st page of
form 5 as
per
prescribed
format.
Blistering
and packing
not
mentioned
in
manufacturi
ng outline.
Submit

complete
manufacturi
ng outline
677. M/s Quaper Z-Max Each Tablet Form-5 Dy.No 1x6’s, The firm is Approved.
Pharmaceuticals 250mg Contains: 18780 dated 30- 10’s; granted
Plant 26-A Small Capsule Azithromycin 07-2020 As per GMP
Industrial Esatte Dihydrate Eq. Rs.20,000/- SRO certificate
Lahore Road to Dated 30-07- based on
Sargodha Azithromycin 2020 inspection
…250mg dated 28-
01-2019.
6.Azithromycin capsule 500 mg:

Composition: Each Capsule Contains:
Azithromycin Dihydrate eq to Azithromycin………………………...……500mg
Availability in RRAs: Could not be confirmed
ME too status: Azithromycin 500mg Capsules by M/s Unipharma (Reg. No. 071422)
Specifications:
USP
Note: Amperometer electrochemical with dual glassy carbon electrodes is required as per available
monograph of USP 42.
form Price status
678. M/s Shazal's Azimal Each capsule Form-5 Dy.No 6’s; As The firm Deferred
Pharmaceuticals. 500mg Contains: 18776 dated 30- per SRO was for
Plot No.41/1-A, Capsule Azithromycin 07-2020 inspected evidence of
Phase-I, Industrial as Rs.20,000/- on 13-02- approval
Estate, Hattar dihydrate.…… Dated 30-07- 2019 and of applied
..500mg 2020 09-01- formulatio
2020 and n in
the panel reference
unanimous regulatory
ly authorities
recommen adopted by
ds Registratio
resumption n Board in
of 275th
production meeting.
activities
in all
sections of
the firm.
679. M/s Linz Azax Each capsule Form-5 Dy.No 3’s, 6’s, Inspection Deferred
Pharmaceuticals 500mg Contains: 16166 dated 07- 10’s; As date for
Pvt Ltd capsule Azithromycin 07-2020 per SRO 09/01/202 evidence of
Plot No 31-G & Dihydrate Eq. Rs.20,000/- 0, approval
31-H, Sector 15 to Dated 06-07- GMP of of applied
Korangi Azithromycin 2020 the formulatio
Induatrial Area …500mg firm is n in
Karachi rated as reference
Good. regulatory
authorities
adopted by
Registratio
n Board in

275th
meeting.
680. M/s Bosch Zezot Each capsule Form-5 Dy.No 3’s, 6’s, Inspection Deferred
Pharmaceuticals 500mg Contains: 16167 dated 07- 10’s; As dated for
Pvt Ltd. capsule Azithromycin 07-2020 per SRO 17/09/201 evidence of
Bosch House 221, Dihydrate Eq. Rs.20,000/- 9, approval
222, & 223, to Dated 06-07- Acceptable of applied
Sector 23, Azithromycin 2020 level of formulatio
Korangi …500mg GMP n in
Industrial Area, complianc reference
Karachi, Pakistan e. regulatory
authorities
adopted by
Registratio
n Board in
275th
meeting.
7.Azithromycin sachet 1000mg:

Composition: Each Sachet Contains:
Azithromycin as Dihydrate………………………...1g
Availability in RRAs: ZITHROMAX (1g) for oral suspension supplied in single-dose packets containing
azithromycin as dihydrate USFDA Approved
ME too status: N/A
Specifications:
Innovators
No. applicant Name / fee / form Size / GMP status
Price
681. M/s Linz Azax 1gm Each Sachet Form-5D Dy.No 1x10’ Inspection of Deferred
Pharmaceuticals Sachet Contains: 16163 dated 07- s, Bosch for
Pvt Ltd Azithromycin 07-2020 1x14’ Pharma confirmati
Plot No 31-G & Dihydrate Eq. Rs.50,000/- s; As dated on of
31-H, Sector 15 to Dated 06-07- per 17/09/2019, required
Korangi Azithromycin 2020 (contract SRO Acceptable manufactu
Industrial Area …1000mg + new level of ring
Karachi molecule)? GMP facility for
Contract compliance. applied
manufactured Submitted formulatio
By: Fee is Rs. n.
M/s Bosch 50000/- (for
Pharmaceuticals contract
Pvt Ltd. manufacturin
Bosch House 221, g) and new
222, & 223, molecule
Sector 23, applied on
Korangi contract
Industrial Area, manufacturin
Karachi, Pakistan g?
The firm
submitted
contract
manufacturin
g agreement
between M/s
Linz
Pharmaceuti
cals and M/s
Bosch
Pharmaceuti
cals
The firm
submitted
list of 4
approved
sections
The firm did
not submit
list of
products
already
registered/ap
proved on
contract
manufacturin
g in the name
of applicant
The firm
submitted
list of 07
applied
products for
contract
manufacturin
g. Stability
study data
required
682. M/s Bosch Zezot 1gm Each Sachet Form-5D Dy.No 1x10’ Inspection Deferred
Pharmaceuticals Sachet Contains: 16168 dated 07- s, dated for
Pvt Ltd. Azithromycin 07-2020 1x14’ 17/09/2019, confirmati
Bosch House 221, Dihydrate Eq. Rs.50,000/- s; As Acceptable on of
222, & 223, to Dated 06-07- per level of required
Sector 23, Azithromycin 2020 SRO GMP manufactu
Korangi …1000mg compliance. ring
Industrial Area, Stability facility for
Karachi, Pakistan study data the applied
required formulatio
n.
683. M/s Quaper Z-Max 1g Each sachet Form-5 Dy.No 1x10’ The firm is Approved.
Pharmaceuticals Sachet Contains: 18779 dated 30- s, granted
Plant 26-A Small Azithromycin 07-2020 1x3’s GMP
Industrial Esatte Dihydrate Eq. Rs.50,000/- ; As certificate
Lahore Road to Dated 30-07- per based on
Sargodha Azithromycin 2020 SRO inspection
…1g dated 28-01-
2019.
8.Azithromycin lyophilized/ powder for solution for Infusion 500mg/vial:

Composition:
Each vial Contains:
Azithromycin dihydrate eq to Azithromycin…….500mg
ZITHROMAX (500mg) lyophilized powder for injection, for intravenous use USFDA Approved

Me-too status:
Macrocap 500mg Dry Powder Injection by M/s Aries Pharmaceuticals (Reg. No. 82589)
Specifications:
USP
Price status
684. M/s BF Azofer Each Vial Form-5 Dy.No 10ml;A Last GMP Deferred
Biosciences 500mg/Vial Contains: 16818 dated 13- s per inspection for
Limited. Lyophilized Azithromycin 07-2020 SRO conducted confirmat
5-Km, Sunder- Powder for (as Rs.20,000/- on 22-08- ion of
Raiwind Road, Solution for dihydrate)…5 Dated 13-07- 2019 manufact
Raiwind, Lahore, Infusion 00mg 2020 wherein uring
Pakistan the panel facility
recommen
ded the
renewal of
DML
b. Deferred cases (Human-Covid):
685. M/s Variant Varibac Each Vial Dy.No. 1’s 9,20-12-2019, The panel
Pharmaceuticals 500mg IV Contains: 11289 vial, recommends grant of DML.
Pvt Ltd. lyophilized Azithromycin dated As per General Dry powder Injection
Plot No 5, M2- sterile Dihydrate Eq.18/05/2020 SRO section (Pre-lyophilized) vial
Pharmazone, 26 powder for to Rs. is present
Km, Main Injection Azithromycin 20,000/-
Sharaqpur Road, …500mg dated 18-
Sheikhupura, 05-2020
Pakistan Form 5
Previous Deferred for confirmation of required manufacturing facility i.e., Lyophilized vial
Decision (295- injectable section.
DRB)
Evaluation by The firm has submitted letter No. F.1-1/2016-Lic dated 24th February 2020 issued by
PEC secretary CLB, in which General Dry powder Injection section (Pre-lyophilized) vial is
granted while the applied product is lyophilized powder for Injection
Decision: Deferred for confirmation of required manufacturing facility i.e., Lyophilized vial injectable
section.
686. M/s Swiss Rocin Each Film Form-5 10’s M/s: Swiss Pharma
Pharmaceutical 500mg Coated Tablet Dy.No 16855 14’s Last GMP inspection conducted
s Pvt Ltd. Tablet Contains: dated 07-03- 20’s; on 18-10-2018.and report
A-159, S.I.T.E Azithromycin 2019 As concludes overall current GMP
Super as Rs.20,000/- per compliance level is rated as
Highway, Dihydrate…5 Dated 07-03- SRO good.
Karachi, 00mg 2019 Master formulation and method
Pakistan of manufacturing not submitted
Previous Deferred for submission of master formulation and method of manufacturing.
Decision (295-
DRB)
Evaluation by The firm submitted master formulation and manufacturing method
PEC
Decision: Deferred for submission of fee applicable for variation in application.

687. M/s Swiss Rocin Each 5ml Form-5 30,60, 2018- GMP compliance is
Pharmaceutical 200mg/5ml contains: Dy.No 11425 120ml rated as good.
s Pvt Ltd. Oral Azithromycin dated 05-03- ; As
A-159, S.I.T.E Powder monohydrate 2019 per
Super Suspension …200mg Rs.20,000/- SRO
Highway, Dated 05-03-
Karachi, 2019
Pakistan
Previous Deferred for correct salt form and fee
Decision (295-
DRB)
Evaluation by The firm submitted revised form 5 and revised label claim along with submission of Rs.
PEC 5000/- on deposite slip No. 1996272 dated 10-08-2020.
The revised label claim is as under:
Each 5ml contains:
Azithromycin (as monohydrate)……200mg
Decision: Approved.
Item No. I: Agenda of Evaluator PEC-IX

a. New cases
688. Name and address of manufacturer/ M/s Maxitech Pharma Pvt Ltd. Plot No. E-178, S.I.T.E.
Applicant Super Highway, Phase II, Karachi
Brand Name + Dosage Form + Lowvat-A 10/10 mg Tablet
Strength
Atorvastatin as calcium trihydrate…10mg
Diary No. Date of R & I & fee Dy. No. 13527; 07.03.2019
PKR. 20,000/-; 06.03.2019
Pharmacological Group HMG CoA reductase inhibitors, other combinations
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer’s specifications
Pack size & Demanded Price as per SRO
Approval status of product in Reference CADUET® (amlodipine as besylate and atorvastatin as
Regulatory Authorities. calcium) tablets, film-coated. USFDA approved
Me-too status Corsafe AT 10/10 Tablets. Reg No. 68320

GMP status The firm was inspected on 21.02.2019 with the following
conclusion: Based on above observations and keeping in
view the attitude of the management of the firm towards
constant improvement their current GMP compliance level
is rated as Good.
Remarks of the Evaluator (IX)

Strength

PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Me-too status Corsafe AT 10/20 Tablets. Reg No. 68321

is rated as Good.

Strength
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Me-too status Zodip Plus 20 Tablet. Reg No. 83294

is rated as Good.
Remarks of the Evaluator(IX) 
Brand Name + Dosage Form + Fetrex 0.025% Cream
Strength

Composition Each Gram of Cream Contains:
Fluocinolone Acetonide…0.25mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form 5
Pack size & Demanded Price 15g, 30g; as per SRO
Approval status of product in Reference Synlar Cream 0.025%. USFDA approved
Me-too status Dermolone Cream 0.025%. Reg. No. 41891
is rated as Good.
Brand Name + Dosage Form + Fetrex C Cream
Strength
Clioquinol…3mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Clioquinol, combinations
Type of Form Form 5
Approval status of product in Reference Synalar C Cream 0.025/3%. MHRA approved
Me-too status Synalar C Cream. Reg. No. 30866
is rated as Good.
Brand Name + Dosage Form + Fetrex C Ointment
Strength
Clioquinol…3mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Clioquinol, combinations
Type of Form Form 5
Approval status of product in Reference Synalar C Ointment 0.025/3%. MHRA approved
Me-too status Synalar C Ointment. Reg. No. 30865
is rated as Good.
Brand Name + Dosage Form + Univate 0.05% Cream
Strength
Halobetasol Propionate…0.5mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g; as per SRO
Approval status of product in Reference Ultravate® (halobetasol propionate) Cream, 0.05%.
Regulatory Authorities. USFDA approved
Me-too status Halovate Cream 0.05%. Reg. No. 46990
is rated as Good.
Decision: Deferred for consideration on its turn..
Brand Name + Dosage Form + Univate 0.05% Ointment
Strength
Halobetasol Propionate…0.5mg
PKR. 20,000/-; 06.03.2019
Type of Form Form 5
Pack size & Demanded Price 10g, 15g, 30g; as per SRO
Approval status of product in Reference Ultravate® (halobetasol propionate) Ointment, 0.05%.
Me-too status Halovate Ointment 0.05%. Reg. No. 46989
is rated as Good.
Brand Name + Dosage Form + Laxolol Sachet
Strength
Macrogol…13.125g
Sodium Chloride…0.3507g
Sodium Hydrogen Carbonate…0.1785g
Potassium Chloride…0.0466g
PKR. 20,000/-; 06.03.2019
Pharmacological Group Osmotic laxative
Type of Form Form 5
Approval status of product in Reference Movicol 13.8g sachet, powder for oral solution. Approved
Regulatory Authorities. by MHRA
Me-too status Forlax Sachet. Reg. No. 82099
is rated as Good.
Brand Name + Dosage Form + Mebis Sachet
Strength
Mebevirine as Hcl…135mg
Ispaghula Husk…3.5mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Drugs for functional gastrointestinal disorders
Type of Form Form 5
Approval status of product in Reference Fybogel Mebeverine Granules for oral suspension Reckitt
Regulatory Authorities. Benckiser Healthcare (UK) Limited, approved by MHRA,
The firm has mentioned powder
Me-too status Mebsyl Sachet by Neutro Pharma (Pvt) Ltd., Lahore Reg.
No. 74307
is rated as Good.
Remarks of the Evaluator(IX)  Submit complete manufacturing outlines from
dispensing to blistering
Brand Name + Dosage Form + Maltomax-F Syrup
Strength
Iron (III) Hydroxide Polymaltose Eq. to Elemental
Iron…50mg
Folic Acid…0.35mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Iron in combination with folic acid
Type of Form Form 5
Me-too status Poly-F Syrup. Reg. No. 64045
is rated as Good.

Brand Name + Dosage Form + Clospo 100mg Soft Gelatin Capsule
Strength
Composition Each Soft Gelatin Capsule Contains:
Cyclosporine…100mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Immunosuppresants
Type of Form Form 5
Approval status of product in Reference NEORAL® Soft Gelatin 100mg Capsule. USFDA
Regulatory Authorities. approved
Me-too status SANDIMMUN CAPSULES 100MG. Reg, No. 12176
is rated as Good.
Brand Name + Dosage Form + Clospo 50mg Soft Gelatin Capsule
Strength
Cyclosporine…50mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Immunosuppresants
Type of Form Form 5
Approval status of product in Reference NEORAL® Soft Gelatin 50mg Capsule. USFDA not
Regulatory Authorities. discontinued or withdrawn for safety or efficacy reasons
Me-too status CYSPINRAL CAPSULES 50MG. Reg, No. 18272
is rated as Good.


Brand Name + Dosage Form + Nidin 10mg Soft Gelatin Capsule
Strength
Nifedipine…10mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Dihydropyridine derivatives
Type of Form Form 5
Pack size & Demanded Price ; as per SRO
Approval status of product in Reference Nifedipine soft capsules 10 mg. MHRA approved
Me-too status Nifedil Sg Capsule 10mg. Reg. No. 31291
is rated as Good.
Brand Name + Dosage Form + Co-Ibtan 150/12.5 mg Tablet
Strength
Irbesartan…150mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Irbesartan and diuretics
Type of Form Form 5
Approval status of product in Reference Avalide tablet 150mg/12.5mg, film-coated. USFDA
Me-too status Co- Irbisaff Tablet 150/12.5. Reg. No. 77191
is rated as Good.

Brand Name + Dosage Form + Mefintin-EZ 80/480 mg Tablet
Strength
Artemether…80mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Artemisinin and derivatives, combinations
Type of Form Form 5
Finished product Specification IP
Approval status of product in Reference WHO Approved formulation
Me-too status Eptrim-X 80/480mg Tablets. Reg. No. 75828
is rated as Good.
Brand Name + Dosage Form + V Artan-S 97/103 mg Tablet
Strength
Sacubitril…97mg
Valsartan…103mg
PKR. 20,000/-; 06.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs), other
combinations
Type of Form Form 5
Approval status of product in Reference ENTRESTO™ (sacubitril and valsartan) 97/103mg
Regulatory Authorities. tablets, film-coated. USFDA approved (with box
warning)
is rated as Good.
Remarks of the Evaluator(IX) Submit all the legal requirements meant for the product
that requires the stability studies as per zone IV-A.
705. Name and address of manufacturer/ M/s Masfa Industries Pvt Ltd 17th Km, Sheikhupura
Brand Name + Dosage Form + Topride Tablets 50mg
Strength
Itopride Hcl…50mg
PKR. 20,000/-; 01.03.2019
Type of Form Form 5
Pack size & Demanded Price 1x10’s; As per SRO
Approval status of product in Reference Itopride hydrochloride tablet 50 mg. PMDA approved
Me-too status Itoride Tablet by Lexicon Pharmaceutical. Reg No. 42040
GMP status The firm was inspected on 29.03.2019, good level of GMP
compliance was reported
Remarks of the Evaluator(IX)
Decision: Approved with innovator’ specifications.

Brand Name + Dosage Form + Levozine Tablet 5mg
Strength
Levocetirizine Dihydrochloride…5mg
PKR. 20,000/-; 01.03.2019
Type of Form Form 5
Pack size & Demanded Price 1x10’s Blister pack , As per SRO
Approval status of product in Reference XYZAL levocetirizine hydrochloride 5 mg film coated
Regulatory Authorities. tablet blister pack. TGA approved
Me-too status Norzin 5 mg Tablets, film-coated. Reg. No. 77965
(IX)
Decision: Approved.
Brand Name + Dosage Form + Skinvate Cream 0.1% w/w 5gm
Strength
Mometasone Furoate…1mg
PKR. 20,000/-; 05.03.2019
Type of Form Form 5
Pack size & Demanded Price 5g; As per SRO
Approval status of product in Reference ELOCON® (mometasone furoate) Cream, 0.1% for
Regulatory Authorities. topical use by Merck Sharp Dohme. US-FDA approved
Me-too status Hivate Creamby Saffron Pharma. Reg. No. 46432
Decision: Approved.
Brand Name + Dosage Form + Fresh cream 0.1%
Strength
Adapalene…1mg
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Finished product Specification BP
Approval status of product in Reference Differin 0.1% Cream. MHRA approved
Me-too status Adapal Cream 0.1%. Reg. No. 83838
Decision: Approved.
Brand Name + Dosage Form + Rexin Tablets
Strength
Piroxicam as betacyclodextrin …20mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Oxicams
Type of Form Form 5
Approval status of product in Reference CYCLADOL 20 mg scored tablet. ANSM approved
Me-too status Utrahit-beta Tablet. Reg. No. 81355

Decision: Approved.
Brand Name + Dosage Form + Mevate Cream 0.05%
Strength
Fluticasone Propionate…0.5mg
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Pack size & Demanded Price 5g; as per SRO
Approval status of product in Reference Fluticasone propionate 0.05% cream. MHRA approved
Me-too status Fluticamax 0.05% Cream. Re. No. 83741

Decision: Approved
Brand Name + Dosage Form + Taco Ointment 0.03%
Strength
Tacrolimus…0.3mg
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications
Pack size & Demanded Price 5g; as per SRO
Approval status of product in Reference Ointment (0.01%, 0.03%) Ointment. USFDA approved
Me-too status Prolimus Ointment 0.03%. Reg. No. 73752
Brand Name + Dosage Form + Velox Tablets 400mg
Strength
Composition Each film-coated tablet Contains:
Moxifloxacin HCL eq to Moxifloxacin…400mg
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Pack size & Demanded Price 5's As per SRO
Approval status of product in Reference AVELOX (moxifloxacin as hydrochloride) 400mg tablets,
Regulatory Authorities. film-coated. USFDA approved
Me-too status Moxizyan 400mg Tablets, film-coated. Reg. No. 77252
 The label claim was “each tablet contains”, but the firm
has mentioned coating composition and process. The firm
revised the label claim to film-coated tablet.
Decision: Deferred for submission of applicable fee for revision of label claim.
Brand Name + Dosage Form + Meflam Tablets 50mg
Strength
Diclofenac potassium…50mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Acetic acid derivatives and related substances
Type of Form Form 5
Pack size & Demanded Price 20’s; as per SRO
Approval status of product in Reference Diclofenac Potassium 50 mg Tablets, film-coated tablet.
Regulatory Authorities. MHRA approved
Me-too status Diclobron-K 50mg Tablets. Reg. No. 54908
Remarks of the Evaluator(IX)  The firm revised Diclofenac potassium…75mg to
Diclofenac potassium…50mg without submission of any
fee.
 The label claim was “each tablet contains”, but the firm
has mentioned coating composition and process. The firm
revised the label claim to film-coated tablet
Decision: Deferred for submission of applicable fee for revision of strength.
Brand Name + Dosage Form + Voral Tablets 100mg
Strength
Composition Each Film Coated SR Tablet Contains:
PKR. 20,000/-; 04.03.2019
Type of Form Form 5

Approval status of product in Reference Dicloflex Retard 100mg prolonged released tablet. MHRA
Regulatory Authorities. Approved.
Me-too status Sintral SR Tablets 100mg. Reg. No. 81413
Remarks of the Evaluator(IX)  The firm has applied for immediate release tablet. The
firm revised the formulation (label claim, composition
and manufacturing outlines) to Film Coated SR Tablet in
line with the reference product without submission of fee.
Decision: Deferred for submission of fee for revision of label claim.
Brand Name + Dosage Form + Dexzole 60mg Capsule
Strength
delayed release pellets Dexlansoprazole…60mg
PKR. 20,000/-; 01.03.2019
Type of Form Form 5
Approval status of product in Reference DEXILANT (dexlansoprazole) delayed-release (30 and 60
Regulatory Authorities. mg) hyperomellose capsules, for oral use. USFDA
approved
Me-too status New molecule
 The firm was asked to submit all the legal requirements
meant for the product that requires the stability studies as
per zone IV-A. The firm submitted stability summary
sheets of the pellets.
Decision: Deferred for submission of stability data as per requirement determined in 293rd
meeting Registration Board.
Brand Name + Dosage Form + Dexzole 30mg Capsule
Strength
delayed release pellets Dexlansoprazole…30mg
PKR. 20,000/-; 01.03.2019
Type of Form Form 5
Approval status of product in Reference DEXILANT (dexlansoprazole) delayed-release (30 and 60
Regulatory Authorities. mg) hyperomellose capsules, for oral use. USFDA
approved
Remarks of the Evaluator(IX)  The firm was asked to submit all the legal requirements
meant for the product that requires the stability studies as
per zone IV-A. The firm submitted stability summary
sheets of the pellets.
meeting Registration Board.
717. Name and address of manufacturer/ M/s Dyson Research Laboratories Pvt Ltd. 28 km
Applicant Ferozepur Road Lahore
Brand Name + Dosage Form + Bromodys Tablets 2.5mg
Strength
Bromocriptine as mesilate…2.5mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Dopamine agonists
Type of Form Form 5
Approval status of product in Reference Parlodel® SnapTabs® (bromocriptine mesylate) tablets,
Regulatory Authorities. USP. USFDA approved
Me-too status Bromit Tablets 2.5mg. Reg. No. 68022
recommendations:
Panel inspected the unit and evaluated documents are
connection with production, quality control and quality
assurance. After thorough inspection of the manufacturing
facility and evaluation of documents panel concluded that
on the day of inspection firm has satisfactory level of
GMP compliance, hence panel recommended issuance of
GMP certificate to the firm. Some advises were also given
in the report to the firm for further up gradations. Copy of
report handed over to the firm.
 Form 5 has not been signed by Mr. Mehmood Ahmed
Virk.
Decision: Deferred for confirmation of required manufacturing facility for applied
formulation.
Brand Name + Dosage Form + Doxilin Syrup 100mg
Strength
Doxofylline…100mg
PKR. 20,000/-; 05.03.2019
Type of Form Form 5
Pack size & Demanded Price 60ml; as per SRO
Approval status of product in Reference DOXOFILLINA ABC “200 mg/10 ml Sciroppo” Flacone
Regulatory Authorities. da 200 ml. AIFA approved
Me-too status Unifyline Syrup. Reg. No. 47180
recommendations:
on the day of inspection firm has satisfactory level of GMP
compliance, hence panel recommended issuance of GMP
certificate to the firm. Some advises were also given in the

report to the firm for further up gradations. Copy of report
handed over to the firm.
Brand Name + Dosage Form + Donris Oral Solution 1mg/ml
Strength
Risperidone…1mg
PKR. 20,000/-; 05.03.2019
Type of Form Form 5
Approval status of product in Reference RISPERDAL® (risperidone) oral solution. USFDA
Regulatory Authorities. approved.
Me-too status Neoris 1mg/ml Solution. Reg. No. 82247
recommendations:
Decision: Approved.
Brand Name + Dosage Form + Dyprotone Tablets 50mg
Strength
Cyproterone Acetate…50mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Antiandrogens, plain
Type of Form Form 5
Approval status of product in Reference Androcur 50 mg tablets, uncoated. MHRA approved
Me-too status ANDROCUR TABLETS. Reg. No. 10221
recommendations:

Remarks of the Evaluator(IX)  Form 5 has not been signed by Mr. Mehmood Ahmed
Virk.
Decision: Deferred for confirmation of required manufacturing facility for applied
formulation.
Brand Name + Dosage Form + Dtsoviron Tablet 25mg
Strength
Mesterolone…25mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group 5-androstanon (3) derivatives
Type of Form Form 5
Approval status of product in Reference Pro-viron® 25mg tablet uncoated. MHRA approved
Me-too status Androviron 25mg Tablets. Reg. No. 030471
recommendations:
Virk.
 The firm submitted letter of approval of Tablet
(Hormones) section.
Decision: Deferred for confirmation of required manufacturing facility whether steroidal or
non-steroidal hormone section for applied formulation.
Brand Name + Dosage Form + Dyz Tablets 0.02mg/3mg
Strength
Ethinylestradiol…0.02mg
Drospirenone…3mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Progestogens and estrogens, fixed combinations
Type of Form Form 5
Approval status of product in Reference Eslarila 0.02 mg/3 mg film-coated tablets. MHRA
Me-too status YAZ TABLET 0.02/3mg film-coated. Reg. No. 59087
recommendations:
Virk.
Brand Name + Dosage Form + Lutison Vaginal Tablet 100
Strength
Progesterone…100MG
PKR. 60,000/-; 05.03.2019
Pharmacological Group Pregnen (4) derivatives
Type of Form Form 5
Finished product Specification The firm has claimed innovator’s specifications
Approval status of product in Reference Lutigest 100 mg vaginal tablets. MHRA approved
recommendations:
Remarks of the Evaluator(IX)  Provide proof of me-too product (name and registration
number) with same formulation, salt form and strength
already approved by DRAP. Otherwise, submit all the
legal requirements meant for the product that requires the
stability studies as per zone IV-A.
Decision: Deferred for proof of me-too product (name and registration number) with same
formulation, salt form and strength already approved by DRAP or else submit stability study
data as per requirements of 293rd meeting of Registration board.
Brand Name + Dosage Form + Fenson Tablets 1mg
Strength
Finasteride……..…1mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form 5

Approval status of product in Reference Finasteride 1mg Film-coated Tablets. MHRA approved
Me-too status Prosin Tablet film-coated, 1mg. Reg. No. 83852
recommendations:
Virk.
Brand Name + Dosage Form + Fenson Tablets 5mg
Strength
Finasteride…5mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Testosterone-5-alpha reductase inhibitors
Type of Form Form 5
Approval status of product in Reference Finasteride 5 mg Tablets. MHRA approved
Me-too status Trichogen 5mg Tablet film-coated. Reg. No. 83722
recommendations:
Virk.
Brand Name + Dosage Form + Dyferol Oral Drops
Strength
Cholecalciferol …14400 IU

PKR. 20,000/-; 05.03.2019
Pharmacological Group Vitamin D and analogues
Type of Form Form 5
Approval status of product in Reference Sapvit-D3 14,400 IU/ml oral drops, solution. MHRA
recommendations:
Virk.
 Provide proof of me-too product (name and registration
number) with same formulation, salt form and strength
already approved by DRAP. Otherwise, submit all the
legal requirements meant for the product that requires the
stability studies as per zone IV-A.
Decision: Deferred for:
 Signature on Form 5.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm.
Brand Name + Dosage Form + Tramason 50mg capsule
Strength
Tramadol Hcl…50mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Other opioids
Type of Form Form 5
Approval status of product in Reference Tramadol Hydrochloride 50mg Capsules. MHRA
Me-too status TRAMAL CAPSULES 50mg. Reg. No. 10170
recommendations:

Decision: Approved
Brand Name + Dosage Form + Dymiga Tablet 50mg PR
Strength
Composition Each film coated prologed release tablet contains:
Mirabegron…50mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form-5
Approval status of product in Reference MYRBETRIQ® extended-release (film-coated) tablet, for
Regulatory Authorities. oral administration contains either 25 mg or 50 mg. USFDA
approved
recommendations:
Virk.
 Submit all the legal requirements meant for the product
that requires the stability studies as per zone IV-A.
meeting.
Brand Name + Dosage Form + Dylovir Tablet 200mg
Strength
Acyclovir…200mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Nucleosides and nucleotides excl. reverse transcriptase
inhibitors
Type of Form Form 5
Approval status of product in Reference Aciclovir 200mg tablets. MHRA approved
Me-too status SUPRAVIRAN TABLETS 200. Reg, No. 19539
recommendations:

Decision: Approved.
Brand Name + Dosage Form + Dyfend Tablets 50mg
Strength
Voriconazole…50mg
PKR. 20,000/-; 05.03.2019
Pharmacological Group Triazole derivatives
Type of Form Form 5
Approval status of product in Reference Voriconazole 50mg Film coated Tablet. MHRA approved
Me-too status Vorif tablets 50mg (Reg. # 069765)
recommendations:

Decision: Approved.
Brand Name + Dosage Form + Dyfend Tablets 200mg
Strength
Voriconazole…200mg
PKR. 20,000/-; 05.03.2019
Type of Form Form 5
Approval status of product in Reference VFEND® (voriconazole) 200mg film-coated tablets, for
Regulatory Authorities. oral use. USFDA approved
Me-too status Voric 200mg film-coated Tablet Reg No. 83272
recommendations:

Decision: Approved.
Brand Name + Dosage Form + Dykote Oral Solution 500mg/5ml
Strength
Valproate Sodium…500mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Antiepileptics
Type of Form Form 5
Approval status of product in Reference Epilim Syrup by Aventis Pharma Limited. Approved by
Regulatory Authorities. MHRA
Me-too status Velpril Liquid by Munawar Pharma, (Pvt) Ltd, Lahore.
Reg. No. 27768
recommendations:
Virk.
 Provide proof of reference product (500mg/5ml) in
reference regulatory agencies as defined in 275th
meeting of the registration Board. Otherwise, revise the
strength (label claim and composition) to 200mg/5ml,
along with submission of applicable fee.
 Mention vehicle and its quantity in the master formula
 Signature on Form 5.
 Revision of the strength (label claim and composition) in line with the reference
product, along with submission of applicable fee.
 Mentioning of vehicle and its quantity in the master formula
Brand Name + Dosage Form + Dykote Tablets 500mg
Strength
Composition Each gastro resistant tablet contains:
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Approval status of product in Reference Belvo 500 mg gastro-resistant tablets. MHRA approved
Me-too status Wiproate 500mg Tablets. Reg. no. 64345 (does not depict
enteric coating)
recommendations:
Virk.
Decision: Approved.
Brand Name + Dosage Form + Dykote Tablets 250mg
Strength
Composition Each gastro resistant tablet contains:
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Approval status of product in Reference Belvo 250 mg gastro-resistant tablets. MHRA approved
Me-too status Wiproate 250mg Tablets. Reg. no. 64344 (does not depict
enteric coating)
recommendations:
Virk.
Decision: Approved.
735. Name and address of manufacturer/ M/s Uni-Tech Pharmaceuticals Pvt Ltd. Plot # 4/116-119,
Applicant Sector 21, Korangi Industrial Area, Karachi-74900,
Pakistan
Brand Name + Dosage Form + Unimotrigine 25mg Tablet
Strength
Lamotrigine…25mg
PKR. 20,000/-; 23.01.2019

Type of Form Form 5
Approval status of product in Reference Lamictal 25 mg tablets. MHRA approved
Me-too status Sportin 25mg Tablets. Reg No. 70344
GMP status Show cause Notice/Suspension of Production Orders issued
on 21st May, 2019. The firm has been inspected again,
wherein the panle recommended the resumption of
production except sterile liquid infusion section. The date
of inspection has not been mentioned.
Remarks of the Evaluator(IX) Submit complete manufacturing outlines from dispensing
to blistering and packing.
Decision: Deferred for submission of complete manufacturing outlines from dispensing to
blistering and packing and confirming date of inspection.
Pakistan
Brand Name + Dosage Form + Unimotrigine 50mg Tablet
Strength
Lamotrigine…50mg
PKR. 20,000/-; 23.01.2019
Type of Form Form 5
Approval status of product in Reference Lamictal 50 mg tablets. MHRA approved
Me-too status Sportin 50mg Tablets. Reg No. 70345
Pakistan
Brand Name + Dosage Form + Unidonate 70mg Tablet
Strength
Alendronic acid (as Sodium Trihydrate)…70mg
PKR. 20,000/-; 23.01.2019
Pharmacological Group Bisphosphonates
Type of Form Form 5
Approval status of product in Reference FOSAMAX® (alendronate sodium Trihydrate eq. to
Regulatory Authorities. 70mg free base) uncoated tablets, for oral use. USFDA
approved
Me-too status Osoaid Tablets 70mg. Reg. No. 79761 ( does not
trihydrate form)
The firm revised sodium alendronate….70mg to
Alendronic acid (as Sodium Trihydrate…70mg.
Pakistan
Brand Name + Dosage Form + Unitroxib 60mg Tablet
Strength
Etoricoxib…60mg
PKR. 20,000/-; 23.01.2019
Pharmacological Group Antiinflammatory and antirheumatic products, non-
steroids
Type of Form Form 5
Approval status of product in Reference ARCOXIA etoricoxib 60mg film-coated tablet. TGA
Me-too status Gencox 60mg Tablets film-coated. Reg. No. 78839
Remarks of the Evaluator(IX)  The firm revised the formulation to film-coated
tablet in line with international reference product
without submission of applicable fee.
 Submit complete manufacturing outlines from
dispensing to blistering and packing.
 Submission of fee for revision of formulation.
 Submission of complete manufacturing outlines from dispensing to blistering and
packing.
 confirming date of inspection
Pakistan
Brand Name + Dosage Form + Prewit Injection IM and oral
Strength
Composition Each Injection Contains:
Vitamin D3…500mcg
PKR. 20,000/-; 23.01.2019
Pharmacological Group Form 5
Type of Form BP
Finished product Specification As per DRAP Policy
Pack size & Demanded Price VITAMIN D3 GOOD 200 000 IU / 1 ml, oral solution in
ampoule.
VITAMINE D3 BON 200 000 U.I. / 1 ml, solution
injectable IM en ampoule. ANSM approved
Approval status of product in Reference Accu-D Injection. Reg. No. 79755
Me-too status Form 5
Remarks of the Evaluator (IX) Submit complete manufacturing outlines from dispensing
to filling and packing.
blistering and packing and confirming date of inspection
740. Name and address of manufacturer/ M/s Avant Pharmaceuticals. M-028 H.I.T.E, Lasbela,
Applicant Baluchistan
Brand Name + Dosage Form + Glucotin 500/400 mg Tablet
Strength
Glucosamine Sulphate …500mg
Chondroitin Sulphate…400mg
PKR. 20,000/-; 27.02.2019
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-
steroids
Type of Form Form 5
Approval status of product in Could not be confirmed
Me-too status Dysflex Tablet (Glucosamine as Sulphate Sodium
Chloride). Reg. No. 65964
conclusion:
“All the observations pointed out during the inspection
were discussed with management and they assured for
early compliance. Overall rating of GMP was found good
at the time of inspection.”
Remarks of the Evaluator(IX)  The firm was asked to provide proof of reference
product (same strength and formulation) in
reference regulatory agencies as defined in 275th
meeting of the registration Board.
 The firm has applied for Glucosamine Sulphate as
Sodium Chloride Salt…500mg. The firm was
asked to justify in line with the reference product.
The firm revised the label claim from:
Glucosamine Sulphate as Sodium Chloride
Salt…500mg
Chondroitin Sulphate as Sodium Salt…400mg
to:
Glucosamine Sulphate…500mg
Chondroitin Sulphate…400mg
 This does not match with the reference product.
Decision: Deferred for revision of formulation in line with reference product alonwith
appliacable fee.

Brand Name + Dosage Form + Avedopa 250/25 mg Tablet
Strength
Levodopa…250mg
Carbidopa…25mg
PKR. 20,000/-; 27.02.2019
Pharmacological Group
Type of Form Form 5
Approval status of product in Co-Careldopa 25 mg/250 mg tablets. MHRA approved
Me-too status Validopa Tablets. Reg. No. 31109
conclusion:
Remarks of the Evaluator(IX)  Revise Carbidopa to Carbidopa as monohydrate in
the label claim.
 You have applied for film-coated tablet. Provide
proof of reference product (same strength and
formulation) in reference regulatory agencies as
defined in 275th meeting of the registration Board.
Otherwise, revise the formulation to uncoated
tablet along with submission of applicable fee.
 Revision of Carbidopa to Carbidopa as monohydrate in the label claim.
 Revision of formulation in line with the reference product along with submission of
applicable fee.
Brand Name + Dosage Form + Bupredol SR 150mg Tablet
Strength
Bupropion HCl…150mg
PKR. 20,000/-; 27.02.2019
Type of Form Form 5
Finished product Specification The firm has claimed USP specifications, wherein 25-45%
drug release criterion has been mentioned in initial 1 h.
moreover no gastric-resistant dissolution testing is present.
Approval status of product in Zyban® 150 mg prolonged release tablets, film-coated.
Reference Regulatory Authorities. MHRA approved
Zyban 150 mg prolonged release tablets, film-coated.
HPRA approved
Me-too status Zylexx SR Tablets 150mg. Reg. No. 35470
conclusion:
Remarks of the Evaluator(IX)  The firm revised bupropion to bupropion HCl in
the label claim and master formula along
WITHOUT submission of applicable fee.
 The firm had applied for SR tablet. The firm
revised the label claim from “Each Film Coated
prolonged release tablet contains”.
 The firm has mentioned acrycoat in the core
materials and has mentioned SR coating as a
separate step but did not mention final coating in
the manufacturing outlines. Upon clarification, the
firm mentioned only one coating.
 Bupropion HCl retard Teva 150 mg, modified-
release tablets in Netherlands consists of pre-
blending, wet granulation, drying, milling,
blending final blending, compression, extended
release coating, delayed release coating and
packaging. However, in case of Bupropion HCl
Sandoz retard 150 mg and 300 mg, modified-
release tablets, the tablet cores are subsequently
coated by the prolonged releasing ethyl cellulose
coating, a gastro-resistant coating, and a
hydrophilic film coating and finally imprinted. But
Zyban 150 mg prolonged release tablets, film-
coated, in HPRA does not depict delayed release
coating.
 Fee for revision of salt form.
 Clarification of formulation from the firm in line with the reference product.
Brand Name + Dosage Form + Rusidon 40mg Tablet
Strength
Lurasidone Hcl…40mg
Diary No. Date of R & I & fee Dy. No.8743; 27.02.2019
PKR. 20,000/-; 27.02.2019
Pharmacological Group Indole derivatives
Type of Form Form 5
Approval status of product in ARDIX LURASIDONE lurasidone hydrochloride 40 mg
Reference Regulatory Authorities. film-coated tablet blister pack. TGA approved
conclusion:
 Provide proof of me-too product (name and
registration number) with same formulation, salt
form and strength already approved by DRAP.
Otherwise, submit all the legal requirements
meant for the product that requires the stability
studies in zone IV-A.

meeting.
Brand Name + Dosage Form + Rusidon 80mg Tablet
Strength
Lurasidone Hcl…80mg
PKR. 20,000/-; 27.02.2019
Pharmacological Group Indole derivatives
Type of Form Form 5
Approval status of product in ARDIX LURASIDONE lurasidone hydrochloride 80 mg
Reference Regulatory Authorities. film-coated tablet blister pack. TGA approved
conclusion:
 Provide proof of me-too product (name and
registration number) with same formulation, salt
form and strength already approved by DRAP.
Otherwise, submit all the legal requirements
meant for the product that requires the stability
studies in zone IV-A.
meeting.
745. Name and address of manufacturer/ M/s Linear Pharma Plot # 18, Street # S-4, National
Applicant Industrial Zone, RCCI Rawat, Islamabad
Brand Name + Dosage Form + Fluzipine 6/25mg Capsule
Strength
Olanzapine…6mg
Fluoxetine…25mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Antipsychotics and selective serotonin reuptake inhibitors
Type of Form Form 5
Approval status of product in Reference SYMBYAX (olanzapine and fluoxetine) capsules by Eli
Regulatory Authorities. Lilly
and Company. Approved by US-FDA
Me-too status Co-Depricap 6/25 Capsule by NabiQasim Karachi. Reg.
No. 76135
recommendations:
inspection areas visited, the people met and the documents
reviewed, and considering the findings of the inspection
M/s Linear Pharma Rawat was considered to be operating
at satisfactory level of compliance with GMP standards.

The management is advised to rectify the observations and
submit compliance as an earliest.
Remarks of the Evaluator(IX) The firm revised Fluoxetine…25mg to Fluoxetine as
HCL…25mg without submission of applicable fee.
Decision: Deferred for submission of applicable fee for revision of salt form.
Brand Name + Dosage Form + Rapid 8mg Tablets
Strength
Lornoxicam…8mg
PKR. 20,000/-; 04.03.2019
steroids (oxicams)
Type of Form Form 5
Approval status of product in Reference Xefo 8 mg Film tabletten. Swiss Medic Approved
Me-too status Lornoxi DS 8mg Tablet. Reg. No. 74933
recommendations:
Decision: Approved.
Brand Name + Dosage Form + Rapid 8mg Injection
Strength
Lornoxicam…8mg
PKR. 20,000/-; 04.03.2019
steroids (oxicams)
Type of Form Form 5
Approval status of product in Reference XEFO 8 mg powder and solvent for solution for injection.
Regulatory Authorities. ANSM approved
Me-too status Lenor 8mg Injection. Reg. No. 83160
recommendations:
Remarks of the Evaluator(IX)  The firm has provided label claim is “Each 2ml contains”
and provided manufacturing outlines of liquid injection.
Revise the label claim and manufacturing outlines in line
with the reference product along with submission of
applicable fee.
Decision: Deferred for confirmation of required manufacturing facitlity “Dry power injectable
(Lyophilized)” for applied formulation and revision of the product in line with the reference
product along with submission of applicable fee.
Brand Name + Dosage Form + Leozo 600mg Tablets
Strength
Linezolid…600mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Antibacterials for systemic use
Type of Form Form 5
Approval status of product in Reference ZYVOX® (linezolid) tablets (film-coated) for oral use by
Regulatory Authorities. Pharmacia and Upjohn. USFDA approved
Me-too status Ozlin 600 mg Tablet by Linta Pharmaceuticals. Reg No.
78179
recommendations:
reviewed, and considering the findings of the inspection,

Brand Name + Dosage Form + Medonac 75mg/3ml Injection
Strength
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Approval status of product in Reference Diclofenac Sodium 75 mg/3 ml Solution for Injection
Me-too status Adfenac Injection 75mg/3ml/ Reg. No. 78635
recommendations:

Brand Name + Dosage Form + Thiomuslax 4mg
Strength
PKR. 20,000/-; 04.03.2019
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form-5
Approval status of product in Reference MIOREL 4 mg capsule. ANSM approved
Me-too status Muscucoside capsule 4mg. Reg. No. 81656
recommendations:
Brand Name + Dosage Form + Periset 8mg Tablet
Strength
Ondansetron as HCl dihydrate…8mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form 5
Approval status of product in Reference Ondansetron 8 mg Film-coated Tablets. MHRA approved
Me-too status Ondan Tablet film-coated 8mg. Reg No. 82657
recommendations:
Remarks of the Evaluator(IX)  The firm revised ‘Ondansetron as Hydrochloride’ to
“Ondansetron as Hydrochloride dihydrate’. Revise the

same in master formula and adjust its weight as per salt
factor in master formula.
Decision: Deferred for revision of Ondansetron Hydrochloride dihydrate in master formula
and adjust its weight as per salt factor in master formula.
Brand Name + Dosage Form + Periset 4mg Tablet
Strength
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
recommendations:
 The firm revised ‘Ondansetron as Hydrochloride’ to
“Ondansetron as Hydrochloride dihydrate’. Revise the
same in master formula and adjust its weight as per salt
factor in master formula.
Decision: Deferred for revision of Ondansetron Hydrochloride dihydrate in master formula
and adjust its weight as per salt factor in master formula.
Brand Name + Dosage Form + Furomide 20mg/2ml Injection
Strength
Furosemide…20mg
PKR. 20,000/-; 04.03.2019
Pharmacological Group High-ceiling diuretics
Type of Form Form 5
Approval status of product in Reference Furosemide Injection BP 20mg/2ml. MHRA approved
Me-too status Genmide 20mg/2ml Injection. Reg. No. 81546
recommendations:

Decision: Approved.
Brand Name + Dosage Form + Tramol Plus Tablets 37.5mg/325mg
Strength
Tramadol HCl…37.5mg
Paracetamol…325mg
PKR. 20,000/-; 04.03.2019
Type of Form Form 5
Approval status of product in Reference ULTRACET (tramadol hydrochloride and
Regulatory Authorities. acetaminophen) tablets, for oral use by Janssen Pharms
US-FDA approved
Me-too status Tril-P Tablet by Linta Pharmaceuticals. Reg. No. 78181
recommendations:
Remarks of the Evaluator(IX)  The firm had provided correct label claim. In the master
formula, the firm revised Tramadol to Tramadol HCl.
Decision: Approved
755. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt Ltd. Plot No. 11, Sector
Applicant 12-A, North Karachi, Krachi-75850, Pakistan
Contract manufactured by
M/s Safe Pharmaceuticals Pvt Ltd.
Plot No. C.I-20, Sector 6-B, Industrial Area, North
Karachi
Brand Name +Dosage Form + Strength Acefen 150mg/3ml Injection
Aceclofenac…150mg
Diary No. Date of R& I & fee Dy.No 6221 dated 13-02-2019
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Finished Product Specification Innovator’s specs
Pack size & Demanded Price 5 x 3ml ampoule: As per SRO
GMP status Semos Pharma: GMP inspection dated 04-07-2018
concluding good GMP compliance.
Safe Pharma: The firm was inspected on 04.03.2019 with
the following conclusion: All the above observations
pointed out during inspection were discussed with the
management of the firm and they were committed to

overcome before next periodic inspection. Based on the
above observations and keeping in view their attitude for
better compliance, their current compliance level is rated
GOOD.
Remarks of the Evaluator(IX)  The firm submitted that they have no product registered
for contract manufacturing.
 The firm submitted list of 08 approved sections.
 Safe Pharmaceuticals has approval letter of liquid
injection (general) section.
the Registration Board in its 275th meeting is required.
by DRAP (generic / me-too status) along with
registration number, brand name and name of firm is
required.
 Evidence of approval of applied formulation in reference regulatory
Karachi
Brand Name +Dosage Form + Strength Falcither 80mg/ml Injection
Artemether…80mg
Rs.50,000/- Dated 22-02-2019
Type of Form Form 5
Finished Product Specification International Pharmacopoeia
Pack size & Demanded Price 1ml ampoule x 6’s: As per SRO
Approval status of product in WHO Approved formulation
Me-too status Artegen 80mg Injection by Fassgen Pharma (Reg#
056462)
GOOD.
 The firm submitted that they have no product registered

Karachi
Brand Name +Dosage Form + Strength Artimos Injection 30mg/vial
Artesunate…30mg
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Approval status of product in Artesunate dry powder vial 30mg. WHO approved
Me-too status Gen-M Injection 30mg. Reg. No. 76072
GOOD.
 Safe Pharmaceuticals has approval letter of dry powder
injection (lyophilized) section.
Decision: Registration Board referred the case back to the panel to access overall capacity of
the analytical equipments of firm including HPLC keeping in view pharmacopeial and other
Karachi
Artesunate…120mg
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Me-too status Gen-M Injection 120mg. Reg. No. 76073

GOOD.
Karachi
Artesunate…60mg
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Me-too status Artesunate Injection 60mg by Hilton Pharma (Reg#
015531)
GOOD.

Karachi
Brand Name +Dosage Form + Strength Densee 5Mg/ml Injection
Cholecalciferol…5mg
Rs.50,000/- Dated 12-02-2019
Pharmacological Group Vitamin- D
Type of Form Form 5
Finished Product Specification BP
Approval status of product in VITAMIN D3 GOOD 200,000 IU / 1 ml, IM solution for
Reference Regulatory Authorities. injection in ampoule & VITAMIN D3 GOOD 200,000 IU
/ 1 ml, oral solution in ampoule (ANSM France
Approved)
Me-too status Drol- D injection by Regal Pharma (Reg. # 082005)
GOOD.
Karachi
Brand Name +Dosage Form + Strength Deserve 40mg/2ml Injection
Composition Each 2ml contains
Drotaverine hydrochloride…40mg
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Approval status of product in Approved in 3 European Countries
Reference Regulatory Authorities. 1. NO-SPA 40 mg solution for injection by Sanofi
Aventis (OGYEI Hungary Approved)
2. NO-SPA 40 mg / 2 ml solution for injection by Sanofi
Romania (NAMMD Romania Approved)
3. No-Spa 20 mg/ml solution for injection by Chinoin

Pharmaceutical and Chemical Works Co. Ltd (Executive
Agency For Medicinal Products, Bulgaria Approved)
Me-too status NO-SPA Injection of Sanofi Aventis Pakistan
GOOD.
Karachi
Brand Name +Dosage Form + Strength Zumin 40mg Injection
Esomeprazole as sodium …40mg
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Approval status of product in NEXIUM IV esomeprazole 40mg (as sodium) powder for
Reference Regulatory Authorities. Injection vial. (TGA approved)
Me-too status Somezol Injection 40mg by Bosch (Reg# 045386)
GOOD.

Karachi
Brand Name +Dosage Form + Strength Sucrose 100mg/5ml Injection
Iron sucrose…100mg
Rs.50,000/- Dated 12-02-2019
Pharmacological Group Haematinic
Type of Form Form 5
Approval status of product in VENOFER iron 100mg/5mL (as iron(III) hydroxide
Reference Regulatory Authorities. sucrose complex) injection (TGA Approved)
Me-too status Iroject Injection by Medley Pharma (Reg#070173)
GOOD.
 The reference product contains iron(III) hydroxide
sucrose complex which is equivalent to 20mg/ml
elemental Iron. Iron sucrose is gerneric term used for
iron(III) hydroxide sucrose complex in TGA Australia.
Karachi
Brand Name +Dosage Form + Strength Mecob 500mcg/ml Injection
Rs.50,000/- Dated 12-02-2019
Pharmacological Group Vitamin B-12
Type of Form Form 5
Approval status of product in Comezengen injection 500 μg of M/s Tatsumi Chemical
Reference Regulatory Authorities. (PMDA Japan Approved)

Me-too status Flench injection of Tabros Pharma (Reg. # 029050)
GOOD.
Karachi
Brand Name +Dosage Form + Strength Noul 40mg Injection
Omeprazole as sodium…40mg
Rs.50,000/- Dated 12-02-2019
Type of Form Form 5
Approval status of product in Omeprazole 40mg powder for solution for injection of
Reference Regulatory Authorities. Sandoz, UK (MHRA Approved)
Me-too status Zegrid-40 Injection of Shaigan Pharma
GOOD.

Karachi
Brand Name +Dosage Form + Strength Pyrol 1000mg Injection
Paracetamol…1000mg
Rs.50,000/- Dated 12-02-2019
Pharmacological Group Anti pyretic
Type of Form Form 5
Approval status of product in Paracetamol 10 mg/ml Solution for Infusion (100ml vial
Reference Regulatory Authorities. contains 1000mg paracetamol) (MHRA Approved)
Me-too status Provas Infusion 10mg/ml by Sami Pharma (Reg#
053223)
GOOD.
Karachi
Brand Name +Dosage Form + Strength Tram 100mg/2ml Injection
Tramadol hydrochloride…100mg
Rs.50,000/- Dated 12-02-2019
Pharmacological Group Analgesics, Opiates
Type of Form Form 5
Approval status of product in Tramadol 50mg/ml solution for injection of AS Kalceks
Reference Regulatory Authorities. (MHRA approved)
Me-too status Tamadol 100mg/2ml Injection of Highnoon
(Reg#013194)

GOOD.
768. Name and address of manufacturer/ M/s Aulton Pharmaceuticals.
Applicant Plot No. 84/1, Block A, Phase V, Industrial Estate,
Hattar, K.P.K
Brand Name + Dosage Form + Aultaroxit CR 12.5mg Tablet
Strength
Paroxetine Hcl hemihydrate eq. to Paroxetine …12.5mg
PKR. 20,000/-; 01.02.2019
Type of Form Form-5
Approval status of product in PAXILCR enteric, film-coated tablet 12.5mg. USFDA
Reference Regulatory Authorities. approved
Me-too status Jurox CR 12.5 Tablet. Reg. No. 81929 (does not depict
enteric, film coating and hemihydrate form).
GMP status The firm was Inspected on 22-01-2019.The Panel reported
good level of GMP Compliance.
 The firm revised label claim from “Paroxetine Hcl
Eq. to” to “Paroxetine HCl hemihydrate eq. to”.
 Revise your label claim composition of excipients
and manufacturing outline in line with the
reference
 Undertaking at the end of revised Form 5 has not
been signed.
 Revision of label claim from “Paroxetine Hcl hemihydrate Eq. to” to “Paroxetine HCl
hemihydrate eq. to paroxetine” and composition of excipients and manufacturing
outline in line with the reference
 Submission of undertaking at the end of revised Form 5.
769. Name and address of manufacturer/ M/s Alkemy Pharmaceuticals Labs Pvt Ltd, P/9, SITE,
Applicant Hyderabad
Brand Name + Dosage Form + Strength Arte Plus Tablet 80mg/480mg

Artemether…80mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s; Each tablet Rs. 60/-
Approval status of product in Reference WHO Approved formulation
Me-too status Eptrim-X 80/480mg Tablets. Reg. No. 75828
GMP status Latest GMP inspection report is required.
Remarks of the Evaluator(IX)  The firm revised the product from Film Coated
Tablet to plain tablet without submission of
applicable fee.
 The cover letter was meant for 80/480mg strength.
However, all other documents were meant for 20mg
and rivaroxaban has been mentioned. The firm
submitted enclosure of Form 5 with correct label
claim and other contents without submission of
applicable fee.
 First page of Form 5 is still missing.
 Submission of Form-5 alongwith fee for revision of formulation.
 Updated GMP inspection report from QA & LT.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Rivakem Tablet 15mg

Rivaroxaban…15mg
PKR. 20,000/-; 05.12.2018
Pharmacological Group Factor Xa inhibitor
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s; Rs. 7270/- per 14 tablets
Approval status of product in Reference Rivaroxaban 15 mg film-coated tablets. MHRA approved
Me-too status Rivaxo 15mg film-coated Tablet. Reg. No. 80790
(IX)
Decision: Deferred for submission of latest GMP inspection report.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemyfenac 100mg Tablet

Aceclofenac…100mg
PKR. 20,000/-; 05.12.2018
Pharmacological Group Antiinflammatory and antirheumatic products, non-steroids
Type of Form Form 5
Pack size & Demanded Price 10’s; As per SRO
Approval status of product in Reference Aceclofenac 100 mg film-coated Tablets. MHRA approved
Me-too status Anac 100mg Tablet. Reg. No. 81502
Remarks of the Evaluator(IX) The firm has applied for plain tablet. Coating composition
are mentioned thereof. However, the manufacturing outlines

does not depict coating process. The firm revised the
manufacturing outlines.
Revision of label claim to film-coated tablet is required.
 Submission of latest GMP inspection report.
 Revision of label claim to film-coated tablet along with submission of applicable fee.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemsartan Tablet 5mg/160mg

Amlodipine as besilate…5mg
Valsartan…160mg
PKR. 20,000/-; 05.12.2018
Pharmacological Group Antihypertensives
Type of Form Form 5
Pack size & Demanded Price Could not be confirmed
Approval status of product in Reference Exforge film-coated tablet 5/160. USFDA approved
Me-too status VALTAN -M 165 PLUS TABLET. Reg. No. 77206
Remarks of the Evaluator(IX)  The firm had applied for film-coated tablet. The firm
revised the label claim and mentioned the coating
composition in master formula.
 In master formula, the label claim is amlodipine as
besilate. However, in Form 5 it is amlodipine. The
firm did not clarify the same.
 The firm shall submit properly filled enclosure of
Form 5.
 The firm shall also revise amlodipine as besilate to
amlodipine besilate in master formula only.
 Submission of applicable fee for revision of label claim to film-coated tablet.
 Revision of amlodipine to amlodipine as besilate in Form 5.
 Submission of enclosure of Form 5.
 Revision of amlodipine as besilate to amlodipine besilate in master formula only.
 Pack size & Demanded Price
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemsartan Tablet 10mg/160mg

Valsartan…160mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Pack size & Demanded Price Could not be confirmed

Remarks of the Evaluator(IX)  The firm has applied for film-coated tablet. The firm
revised the label claim and mentioned the coating
composition in master formula.
 In master formula, the label claim is amlodipine as
besilate. However, in Form 5 it is amlodipine. The
firm did not clarify the same.
 The firm shall submit properly filled enclosure of
Form 5.
 The firm shall also revise amlodipine as besilate to
amlodipine besilate in master formula only.
 Submission of applicable fee for revision of label claim to film-coated tablet.
 Revision of amlodipine to amlodipine as besilate in Form 5.
 Submission of enclosure of Form 5.
 Revision of amlodipine as besilate to amlodipine besilate in master formula only.
 Pack size & Demanded Price
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kem- Mont 10mg Tablet

Composition Each chewable tablet Contains:
Montelukast (as sodium)…….10mg
PKR. 20,000/-; 05.12.2018
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 14’s, 30’s, 40’s, 50’s,60’s, 70’s, 80’s, 90’s, 100;
Rs. 100 per tablet
Remarks of the Evaluator(IX)  Proof of international availability of same
formulation and same strength in reference
regulatory authorities as defined in 275th meeting of
the registration board is required.
 Provide proof of approval of me-too product (name
registration number and name of company) by
DRAP.
 Revise “Montelukast sodium eq. to. Montelukast” to
“Montelukast sodium” in master formula only.
 Proof of international availability of same formulation and same strength in reference
regulatory authorities as defined in 275th meeting of the registration board.
 Proof of approval of me-too product (name registration number and name of company)
by DRAP.
 Revision of Montelukast sodium eq. to. Montelukast” to “Montelukast sodium” in
master formula only.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kem- Mont 5mg Tablet

Composition Each chewable tablet Contains:
Montelukast (as sodium)…….5mg
PKR. 20,000/-; 05.12.2018
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 14’s, 30’s, 40’s, 50’s,60’s, 70’s, 80’s, 90’s, 100;
Rs. 100 per tablet
Approval status of product in Reference SINGULAIR® (montelukast sodium) Chewable Tablets.
Me-too status Nohist Chewable Tablet 5mg. Reg. No. 85712
Revise “Montelukast sodium eq. to. Montelukast” to
“Montelukast sodium” in master formula only.
 Revision of Montelukast sodium eq. to. Montelukast” to “Montelukast sodium” in
master formula only.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemyflox 400mg Tablet

Composition Each Film-coated tablet Contains:
Moxifloxacin HCl…400mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Pack size & Demanded Price 5’s; Rs. 465/-
Approval status of product in Reference AVELOX (moxifloxacin as hydrochloride) 400mg tablets,
Remarks of the Evaluator(IX) Undertaking at the end of Form 5 is missing.
 Submission of undertaking at the end of Form 5.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemylid 600mg Tablet

Linezolid…600mg
PKR. 20,000/-; 05.12.2018
Pharmacological Group Other antibacterials
Type of Form Form 5
Approval status of product in Reference ZYVOX® (linezolid) 600mg tablets (film-coated) for oral
Regulatory Authorities. use by Pharmacia and Upjohn. US-FDA approved
Me-too status Ozlin 600 mg Tablet by Linta Pharmaceuticals. Reg No.
78179
Decision: Deferred for submission of latest GMP inspection report.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemadol-P 37.5/325mg Tablet

Tramadol hcl….37.5mg
Paracetamol…325mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Approval status of product in Reference ULTRACET (tramadol hydrochloride and acetaminophen)
Regulatory Authorities. tablets, for oral use by Janssen Pharms US-FDA approved
Me-too status Tril-P Tablet. Reg. No. 78181
Remarks of the Evaluator(IX) First page of Form 5 is missing.
Revise tramadol as HCl to tramadol HCl and mention
correct quantity of tramadol HCl, i.e., 37.5mg in Master
formula.
 Submission of Form 5 (first page).
 Revision of tramadol as HCl to tramadol HCl (label claim and composition) and
mentioning the correct quantity of tramadol HCl, i.e., 37.5mg in Master formula.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemroxen-E Tablet 500/20mg

Naproxen…500mg
Esomeprazole…20mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Finished product Specification The firm has claimed in-house specification
Pack size & Demanded Price ??
Approval status of product in Reference VIMOVO (naproxen and esomeprazole magnesium
Regulatory Authorities. trihydrate) delayed-release tablets, for oral use (375 mg
enteric-coated naproxen /20 mg immediate-release
esomeprazole film-coated or 500 mg enteric-coated
naproxen /20 mg immediate-release esomeprazole film-
coated). US-FDA approved
Me-too status Tril-P Tablet. Reg. No. 78181
Remarks of the Evaluator(IX)  First page of Form 5 is missing.
 The manufacturing process starts with producing a
core tablet with naproxen. This core tablet is
manufactured by a conventional wet granulation
process. The core tablet is coated with six layers of
film-coating. An enteric coat and barrier coat are
applied prior to the active coat. The fourth coat is
the esomeprazole magnesium trihydrate coat. Revise

the composition and manufacturing outlines
accordingly.
 Revise esomeprazole to esomeprazole as magnesium
Trihydrate in the label claim along with submission
of applicable fee, and adjust its weight in Master
formula as per salt factor.
 Clarification is required regarding the pack size and
demanded price.
 Clarification of formulation in line with the reference product.
 Revision of esomeprazole to esomeprazole as magnesium Trihydrate in the label claim
along with submission of applicable fee, and adjustment of its weight in Master formula
as per salt factor.
 Clarification regarding the pack size and demanded price.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Kemfylin Syrup 100mg/5ml

Doxofylline…100mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Pack size & Demanded Price 30ml; Rs. 170/-, 60ml; Rs. 180/-, 90ml; Rs. 170/-, 100ml;
Rs. 220/-, 120ml; Rs. 350/-, 450ml; Rs. 500/-
Approval status of product in Reference DOXOFILLINA ABC “200 mg/10 ml Sciroppo” Flacone da
Regulatory Authorities. 200 ml. AIFA approved
Me-too status Unifyline Syrup. Reg. No. 47180
(IX)
Remarks of the Evaluator First page of Form 5 is missing.
Applicant Hyderabad
Brand Name + Dosage Form + Strength Zaridine Syrup 5mg/5ml

Loratadine …5mg
PKR. 20,000/-; 05.12.2018
Type of Form Form 5
Pack size & Demanded Price 30ml; Rs. 45/-
Approval status of product in Reference Loratadine 5 mg/ 5 ml syrup. MHRA approved
Me-too status Histagon Syrup 5mg/5ml. Reg. No. 28188
Remarks of the Evaluator(IX) First page of Form 5 is missing.

782. Name and address of manufacturer/ M/s Pearl Pharmaceuticals.
Applicant Plot No. 204, Street No.1, I-10/3, Islamabad
Brand Name + Dosage Form + Triam 500mg Tablet
Strength
Composition Each film coated oral tablet contains:
Tranexamic Acid…500mg
PKR. 20,000/-; 28.02.2019
Type of Form Form 5
Pack size & Demanded Price 2x10’s; as per SRO
Approval status of product in Reference CYKLOKAPRON tranexamic acid 500mg tablet, film-
Regulatory Authorities. coated. TGA approved
Me-too status Traumax Tablet. Reg. No. 24787 (dose not depict film-
coating)
Recommendations/Desired Action:
The firm was found in satisfactory compliance with GMP
guidelines, documents including SOP's log books were
found intact and implemented. Although the firm was
directed to shift all of the existing registered products
specifications for testing from in-house to international
pharmacopoeias where applicable, as per drug
specifications rules of drug act, 1976/DRAP Act, 2012 and
make available all the testing requisites including columns
and certified reference standards.
Decision: Approved.
Brand Name + Dosage Form + Nebid 10mg Tablet
Strength
Nebivolol as HCl…10mg
PKR. 20,000/-; 28.02.2019
Pharmacological Group HMG CoA reductase inhibitors
Type of Form Form 5
Approval status of product in Reference BYSTOLIC® (nebivolol 2.5mg, 5mg, 10mg, 20mg)
Regulatory Authorities. tablets, uncoated. USFDA approved
Me-too status Bynevol 10mg Tablet by Atco Lab Karachi. Reg No.
81562

Remarks of the Evaluator(IX)  The firm revised the formulation (label claim,
composition and manufacturing outlines) from fil-coated
to uncoated tablet, along with submission of Rs. 5000/-
fee.
Brand Name + Dosage Form + Nebid 5mg Tablet
Strength
Nebivolol as HCl…5mg
PKR. 20,000/-; 28.02.2019
Pharmacological Group HMG CoA reductase inhibitors
Type of Form Form 5
Approval status of product in Reference BYSTOLIC® (nebivolol 2.5mg, 5mg, 10mg, 20mg)
Regulatory Authorities. tablets, uncoated. USFDA approved
Me-too status Bynevol 5mg Tablet by Atco Lab Karachi. Reg No. 81099
Remarks of the Evaluator(IX)  The firm revised the formulation (label claim,
composition and manufacturing outlines) from fil-coated
to uncoated tablet, along with submission of Rs. 5000/-
fee.
Brand Name + Dosage Form + Olmedin 5/20mg Tablet
Strength
Amlodipine besylate eq to Amlodipine…5mg
PKR. 20,000/-; 28.02.2019
Type of Form Form 5
Approval status of product in Reference AZOR 5/20 mg (amlodipine and olmesartan medoxomil)
Me-too status Olmis-A 5mg/20mg Tablet. Reg. No. 83256


Brand Name + Dosage Form + Olmedin 5/40mg Tablet
Strength
PKR. 20,000/-; 28.02.2019
Type of Form Form 5
Approval status of product in Reference AZOR 5/40 mg (amlodipine and olmesartan medoxomil)
Me-too status Olmis-A 5mg/20mg Tablet. Reg. No. 883257
787. Name and address of manufacturer/ M/s Briell Pharmaceuticals Pvt Ltd. 538-C Sundar
Applicant Industrial Estate Road, Lahore. By M/s Medisave
Lahore, Pakistan
Brand Name + Dosage Form + Savix 100mg/5ml Dry Powder Suspension
Strength
Composition Each 5ml of reconstituted suspension contains:
Cefixime Trihydrate eq to Cefixime…100mg
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Pack size & Demanded Price Powder for 30ml suspension; As per SRO
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension.
Reference Regulatory Authorities. MHRA approved
Me-too status Elixime Dry Suspension 100mg. Reg. No. 53729
GMP status Applicant: The firm was inspected on 24.05.2019 with the
following conclusion: The firm was evaluated for facilities
like building, HVAC System, quality control, quality

assurance and production operations. The Briell Pharma
found to be operating at satisfactory level of GMP
compliance.
Manufacturer: GMP Certificate issued on 15-03-2018.
Remarks of the Evaluator(IX)  The firm submitted 05 approved sections, no
approved products for contract manufacturing and
22 applied products for contact manufacturing of
the applicant (M/sBriell Pharma).
Decision: Deferred for capacity assessment of M/s Medisave pharmaceuticals, Lahore.
Lahore, Pakistan
Brand Name + Dosage Form + Savix 200mg/5ml Dry Powder Suspension
Strength
Composition Each 5ml of reconstituted suspension contains:
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Pack size & Demanded Price Powder for 30ml suspension; As per SRO
Approval status of product in SUPRAX® (cefixime) for oral suspension. USFDA
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + Savix 400mg Capsule
Strength
PKR. 50,000/-; 19.02.2019
Pharmacological Group Third generation cephalosporins
Type of Form Form 5
Approval status of product in SUPRAX® (cefixime) capsules, for oral use by Lupin
Reference Regulatory Authorities. Ltd for Lupin Pharma. Approved by US-FDA
Me-too status Nowcef 400mg Capsule by Nawan Lab. Karachi. Reg.
No. 82219

compliance.
Lahore, Pakistan
Brand Name + Dosage Form + B-Cef IM Injection 250mg
Strength
Ceftriaxone sodium eq to Ceftriaxone…250mg
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Approval status of product in Ceftriaxone 250mg (IM) by Lupin Pharmaceuticals Inc.
Reference Regulatory Authorities. US-FDA approved
Me-too status Unixone Injection (ceftriaxone Sodium) 250mg IM by
Caliph Pharmaceuticals (Pvt.) Ltd. Reg. No. 82556
compliance.
the applicant (M/sBriell Pharma)..
Lahore, Pakistan
Brand Name + Dosage Form + B-Cef IM Injection 500mg
Strength
PKR. 50,000/-; 19.02.2019
Type of Form Form 5

Approval status of product in Ceftriaxone 500mg (IM) by Lupin Pharmaceuticals Inc.
Me-too status Wincef 500 mg (Ceftriaxone sodium) IM injection by
Wnsfeild Pharmaceuticals. Reg. No. 68371
compliance.
 The firm submitted 05 approved sections, no
Lahore, Pakistan
Brand Name + Dosage Form + B-Cef IV Injection 250mg
Strength
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Approval status of product in Ceftriaxone 250mg (IV) by Lupin Pharmaceuticals Inc.
Me-too status Ceftirains 250mg (ceftriaxone Sodium) I.V Injection by
Sunrise Pharma (Pvt) Ltd. Reg. No. 78655
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + B-Cef IV Injection 500mg
Strength
PKR. 50,000/-; 19.02.2019

Type of Form Form 5
Approval status of product in Ceftriaxone 500mg (IV) by Lupin Pharmaceuticals Inc.
Me-too status Wincef 500 mg (Ceftriaxone sodium) IV by Wel Wink
Pharmaceuticals. Reg. No. 78097
compliance.
the applicant (M/sBriell Pharma)..
Lahore, Pakistan
Brand Name + Dosage Form + B-Cef IV Injection 1g
Strength
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Approval status of product in Ceftriaxone 1 g (IV) by Lupin Pharmaceuticals Inc. US-
Reference Regulatory Authorities. FDA approved
Me-too status Martixon 1gm (Ceftriaxone sodium) I.V Dry powder
Injection by Alkemy Pharma. Reg. No. 70663
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + C Pime 500mg dry powder Injection
Strength

Cefepime HCL with L arginine sterile eq to
Cefepime…500mg
PKR. 50,000/-; 19.02.2019
Pharmacological Group Fourth generation cephalosporins
Type of Form Form 5
Approval status of product in MAXIPIME (cefepime hydrochloride) for injection, for
Reference Regulatory Authorities. intravenous or intramuscular use (500mg, 1g, 2g).
USFDA Approved
Me-too status Cefevial Injection 500 mg IV Reg. No. 80029
compliance.
 The firm revised Cefepime HCL with L arginine
sterile eq to Cefepime…500mg to Cefepime as
HCl monohydrate with L-arginine. …500mg.
Lahore, Pakistan
Brand Name + Dosage Form + C Pime 1g dry powder Injection
Strength
Cefepime HCL with L arginine sterile eq to
Cefepime…1g
PKR. 50,000/-; 19.02.2019
Pharmacological Group Fourth generation cephalosporins
Type of Form Form 5
Approval status of product in MAXIPIME (cefepime hydrochloride) for injection, for
Reference Regulatory Authorities. intravenous or intramuscular use (500mg, 1g, 2g).
USFDA Approved
Me-too status Cefevial Injection 1g IV Reg. No. 80030
compliance.

 The firm revised Cefepime HCL with L arginine
sterile eq to Cefepime…1g to Cefepime as HCl
monohydrate with L-arginine. …1g.
Lahore, Pakistan
Brand Name + Dosage Form + D-Rise 5mg/ml Injection IM/oral
Strength
Cholecalciferol …5mg
PKR. 50,000/-; 19.02.2019
Pharmacological Group Vitamin D and analogues
Type of Form Form 5
Approval status of product in VITAMIN D3 GOOD 200 000 IU / 1 ml, oral solution in
Reference Regulatory Authorities. ampoule.
VITAMINE D3 BON 200 000 U.I. / 1 ml, solution
injectable IM en ampoule. ANSM approved
Me-too status Accu-D Injection. Reg. No. 79755
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + Irolic 100mg/5ml Injection
Strength
Iron sucrose eq to elemental iron…100mg
PKR. 50,000/-; 19.02.2019
Pharmacological Group Iron preparations
Type of Form Form 5
Pack size & Demanded Price 5ml ampule; As per SRO
Approval status of product in VENOFER iron 100mg/5mL (as iron(III) hydroxide
Reference Regulatory Authorities. sucrose complex) injection ampoule. TGA approved
Me-too status Orsec Injection 100mg/5ml. Reg. No.82559

compliance.
elemental Iron. Iron sucrose is gerneric term used
for iron(III) hydroxide sucrose complex in TGA
Australia.
Lahore, Pakistan
Brand Name + Dosage Form + Linstar 600mg/300ml Injection
Strength
Linezolid…600mg
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Pack size & Demanded Price 300ml vial; as per SRO
Approval status of product in ZYVOX linezolid 600mg/300mL injection infusion bag.
Reference Regulatory Authorities. TGA approved
Me-too status Oxalid Infusion 600mg/300ml. Reg. No. 82579
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + Tolac 30mg/ml Injection
Strength
Ketorolac Trometamol…30mg
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Pack size & Demanded Price 1ml x 5’s ampule; As per SRO

Approval status of product in TORADOL ketorolac trometamol 30mg/1mL injection
Reference Regulatory Authorities. ampoule. TGA approved
Me-too status Syntor 30 mg Injection IV/IM. Reg. No.83365
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + Ondex 8mg/4ml Injection
Strength
Ondansetron as Hcl dihydrate…8mg
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Approval status of product in Ondansetron 2mg/ml Solution for Injection or Infusion
Reference Regulatory Authorities. (1ml, 2ml, 4ml ampule). MHRA approved.
Me-too status Ondenles 8mg Injection (4ml). Reg. No. 80548
Adosetron 4mg Injection (2ml). Reg. No. 78789
compliance.
 The firm revised Ondansetron Hcl
dihydrate…8mg to Ondansetron as Hcl
dihydrate…8mg.
Lahore, Pakistan
Brand Name + Dosage Form + Magnix 1g Injection
Strength
Cefoperazone sodium eq to Cefoperazone…500mg
Sulbactum sodium eq to sulbactum…500mg

PKR. 50,000/-; 19.02.2019
Pharmacological Group Third generation cephalosporins and beta-lactamase
inhibitors
Type of Form Form 5
Approval status of product in Sulperazon Injection. PMDA Approved
compliance.
Lahore, Pakistan
Brand Name + Dosage Form + Magnix 2g Injection
Strength
Cefoperazone sodium eq to Cefoperazone…1g
Sulbactum sodium eq to sulbactum…1g
Diary No. Date of R & I & fee Dy. No. 7001 ; 19.02.2019
PKR. 50,000/-; 19.02.2019
inhibitors
Type of Form Form 5
Approval status of product in Approved in 03 European countries, i.e., Czech Republic,
Reference Regulatory Authorities. Poland and Slovakia
compliance.

Lahore, Pakistan
Brand Name + Dosage Form + Zymox 400mg/250ml Infusion
Strength
Moxifloxacin as HCl…1.6mg
PKR. 50,000/-; 19.02.2019
Type of Form Form 5
Approval status of product in AVELOX IV 400 moxifloxacin 400 mg/250 mL (as
Reference Regulatory Authorities. hydrochloride) intravenous infusion solution bottle. TGA
approved
Me-too status Esobrain Injection 40mg. Reg. No. 85072
compliance.
 The firm revised Moxifloxacin HCl to
Moxifloxacin as HCl in the label claim.
Lahore, Pakistan
Brand Name + Dosage Form + Nervex 500mcg/ml Injection
Strength
PKR. 50,000/-; 19.02.2019
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues)
Type of Form Form 5
Pack size & Demanded Price 1mlx10’s (ampule); As per SRO
Approval status of product in Mecobalamin injection 500μg (1ml). PMDA approved
Me-too status Balco 500mcg IM/IV Injection (1ml). Reg. No. 81484
compliance.

806. Name and address of manufacturer/ M/s Shrooq Pharmaceuticals Pvt Ltd. 21-km Ferozpur
Applicant Road, Lahore, Pakistan
Brand Name + Dosage Form + Irosid Injection (5ml)
Strength
Iron (III) Isomaltoside eq. to elemental Iron…100mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Iron, parenteral preparations
Type of Form Form 5
Finished product Specification The firm has claimed manufacturer’s specifications.
Approval status of product in Reference Monofer 100 mg/ml solution for injection/infusion (1ml,
Regulatory Authorities. 2ml, 3ml, 5ml, 10ml ampule/vial) . MHRA approved
Me-too status Wisofer Injection. Reg. No. 78521
GMP status
Brand Name + Dosage Form + Fonic Injection
Strength
Folinic acid (as calcium folinate)…15mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Folic acid analogs (not in ATC)
Type of Form Form 5
Approval status of product in Reference Calcium Folinate (eq to folinic acid) 7.5 mg/mL Injection
Regulatory Authorities. (15mg/2ml). MHRA approved
Me-too status
GMP status The firm has been issued GMP certificate on the basis of
Brand Name + Dosage Form + Ronium Injection 50mg/5ml
Strength
Rocuronium Bromide…50mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Other quaternary ammonium compounds
Type of Form Form 5
Approval status of product in Reference Rocuronium bromide 10 mg/ml solution for
Regulatory Authorities. injection/infusion (vial). MHRA approved
Me-too status ESMERON INJECTION 50MG/5ML. Reg. No. 21154
th
Remarks of the Evaluator(IX)  The firm has claimed ampule packing
Brand Name + Dosage Form + Saprin tablet
Strength
Composition Each film coated tablet contain:
Valsartan…160mg
PKR. 20,000/-; 07.03.2019
Type of Form Form-5

Brand Name + Dosage Form + Flunide Lotion 0.01% w/v
Strength
Composition Each ml of Lotion contains:
Fluocinolone Acetonide…0.1%W/v
PKR. 20,000/-; 07.03.2019
Type of Form Form 5
(available in USP as topical solution)
Pack size & Demanded Price 60ml, 120ml; as per SRO
 You have applied for lotion, but the composition in
master formula are API in oily base. Justify
 The firm submitted Derma-Smoothe/FS® fluocinolone
acetonide Topical Oil, 0.01% approved in USFDA as
reference product.
Brand Name + Dosage Form + Mebewin MR Capsule
Strength
Composition Each extended release capsule contains:
Mebeverine HCl (pellets)…200mg
PKR. 20,000/-; 07.03.2019
Pharmacological Group Synthetic anticholinergics, esters with tertiary amino
group
Type of Form Form 5
Approval status of product in Reference COLOFAC® MR 200mg Capsules. MHRA approved
Me-too status Mebrest-200 Capsule. Reg. No. 80547
Remarks of the Evaluator(IX)  The firm revised Mebeverine as HCl to Mebeverine HCl
in the dossier.
 The source of pellets is Vision Pharmaceuticals,
Islamabad.
Brand Name + Dosage Form + Hepa-Zerm Sachet
Strength
Composition Each Sachet contains:
L-Ornithine-L-Asperate…3g
PKR. 20,000/-; 07.03.2019
Pharmacological Group Liver therapy mentioned as ornithine oxoglurate salt
Type of Form Form 5
Approval status of product in Reference Hepa-Merz Sachet containing ornithine aspartate
Regulatory Authorities. (granules for solution). AGES approved
Me-too status Lolar Sachet. Reg. No. 76499
Remarks of the Evaluator(IX)  The firm applied for powder for solution. The reference
product is granules for solution. The firm revised the
manufacturing outlines to granules.
813. Name and address of manufacturer/ M/s Helix Pharma Pvt Ltd. Hakimsons House, A/56,
Applicant S.I.T.E Manghopir Road, Karachi, Pakistan; contract
manufacturing by: Mediate Pharmaceuticals (Pvt) Ltd.
Plot No. 150-151, Sector 24 Korangi Industrial Area,
Karachi
Brand Name + Dosage Form + Cefo-B/Hilsum Injection 1gm
Strength
Cefoperazone as Sodium…500mg
Sulbactam as Sodium…500mg
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
inhibitors
Type of Form Form 5
Approval status of product in Reference Sulperazon Injection. PMDA Approved
GMP status The firm was last inspected on 10.08.2017, wherein it was
concluded that "Based on the areas inspected, the people
met and documents reviewed of M/s Helix Pharmaceuticals
Pvt. Ltd Karachi found satisfactory and compliant as per
cGMP requirement.”
Remarks of the Evaluator(IX)  The firm revised the label claim from
“Cefoperazone Sodium+
Sulbactam Sodium…1gm” to “Cefoperazone as
Sodium…500mg and Sulbactam as
Sodium…500mg.
 Form 5 signed by Regulatory affair manger.
Decision: Approved.
Karachi
Brand Name + Dosage Form + Cefo-B/Hilsum Injection 2gm
Strength
Cefoperazone as Sodium…1g
Sulbactam as Sodium…1g
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
inhibitors
Type of Form Form 5
Approval status of product in Reference Approved in 03 European countries, i.e., Czech Republic,
Regulatory Authorities. Poland and Slovakia
Remarks of the Evaluator(IX)  The firm revised the label claim from
“Cefoperazone Sodium+
Sulbactam Sodium…2gm” to “Cefoperazone as
Sodium…1g and Sulbactam as Sodium…1g.
Decision: Approved.
Karachi
Brand Name + Dosage Form + Heliphen/Helixone Injection 250mg IM
Strength
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Type of Form Form 5

Approval status of product in Reference Ceftriaxone 250mg (IM) by Lupin Pharmaceuticals Inc.
Regulatory Authorities. US-FDA approved
Me-too status Unixone Injection (ceftriaxone Sodium) 250mg IM by
Caliph Pharmaceuticals (Pvt.) Ltd. Reg. No. 82556
Remarks of the Evaluator(IX) Form 5 signed by Regulatory affair manger.
Decision: Approved.
Karachi
Brand Name + Dosage Form + Heliphen/Helixone Injection 500mg IM
Strength
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Type of Form Form 5
Approval status of product in Reference Ceftriaxone 500mg (IM) by Lupin Pharmaceuticals Inc.
Regulatory Authorities. US-FDA approved
Me-too status Wincef 500 mg (Ceftriaxone sodium) IM injection by
Wnsfeild Pharmaceuticals. Reg. No. 68371
Remarks of the Evaluator(IX)  Form 5 signed by Regulatory affair manger.
Decision: Approved.
Karachi
Brand Name + Dosage Form + Heliphen/Helixone Injection 1gmIM
Strength
Ceftriaxone Sodium eq to Ceftriaxone…1g
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Type of Form Form 5
Approval status of product in Reference Ceftriaxone 1g Powder for Solution for Injection. MHRA
Me-too status Esticef 1g Powder for Injection IM. Reg. No. 85082
Decision: Approved.
Karachi
Brand Name + Dosage Form + Hiloran/Hiltax Injection 250mg
Strength
Cefotaxime sodium…250mg
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
PKR
Type of Form Form 5
Approval status of product in Reference Could not be verified
Me-too status Varxiame 250mg IM/IV Injection. Reg. No. 49270
Decision: Approved.
Karachi
Brand Name + Dosage Form + Hiloran/Hiltax Injection 500mg
Strength
Cefotaxime sodium …500mg
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Type of Form Form 5
Approval status of product in Reference CEFOTAXIME HEXAL INJECTION cefotaxime 500mg
Regulatory Authorities. (as sodium) powder for injection. TGA approved
Me-too status Wincef 500 mg (Ceftriaxone sodium) IV by Wel Wink
Pharmaceuticals. Reg. No. 78097
Decision: Approved.
Karachi
Brand Name + Dosage Form + Hiloran/Hiltax Injection 1gm
Strength
Cefotaxime sodium…1gm
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Type of Form Form 5
Approval status of product in Reference CEFOTAXIME INJECTION cefotaxime 1g (as sodium)
Regulatory Authorities. powder for injection IV. TGA approved
Me-too status Cefotaxime 1g Injection. Reg. No. 49272
Decision: Approved.
Karachi
Brand Name + Dosage Form + Lidocaine Injection 1% 20mg/2ml (ampule)
Strength
Lidocaine HCl…20mg
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Pharmacological Group Local anesthetics
Type of Form Form 5
Approval status of product in Reference LIDOCAINE ACCORD 1% lidocaine (lignocaine)
Regulatory Authorities. hydrochloride 20 mg/2 mL injection ampoule. TGA
approved
Me-too status Lignosyn 1.0% injection IM. Reg. No. 83366
Decision: Approved.
Karachi

Brand Name + Dosage Form + Sterile water for injection 5ml
Strength
Composition Each ampoule contains:
Sterile water for injection…5ml
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Pharmacological Group Solvents and diluting agents, incl. irrigating solutions
Type of Form Form 5
Approval status of product in Reference Sterile water for injection (1ml, 2ml, 3.2ml, 5ml and 10ml)
Regulatory Authorities. ampule Glass class I. MHRA approved
Me-too status Sterile Water for injection 5ml . Reg. No. 81541
Decision: Approved.
Karachi
Brand Name + Dosage Form + Sterile water for injection 10ml
Strength
Sterile water for injection…10ml
PKR. 20,000/-; 09.01.2019; PKR. 30,000/-; 15.03.2019
Pharmacological Group Solvents and diluting agents, incl. irrigating solutions
Type of Form Form 5
Approval status of product in Reference STERILE WATER FOR INJECTION 100% (10ml) in
Regulatory Authorities. vial. USFDA approved
Me-too status Water for Injection (sterile) 10ml in ampule. Reg. No.
76972
Decision: Approved.
824. Name and address of manufacturer/ M/s Searle IV Solutions Pvt Ltd.
Applicant 1.5 km, Manga Raiwind Road, Lahore
Brand Name + Dosage Form + Spasnil 80/80 mg Tablet
Strength
Composition Each Sugar Coated Tablet Contains:
Phloroglucinol Dihydrate Eq. to Phloroglucinol…80mg
Trimethyl Phloroglucinol…80mg
PKR. 20,000/-; 30.11.2018
Type of Form Form 5
Approval status of product in PHLOROGLUCINOL /
Reference Regulatory Authorities. TRIMETHYLPHLOROGLUCINOL ACINO 62.233 mg /
80 mg, coated tablet by ACINO France SAS. Approved
by ANSM
Me-too status Despasm Tablet by Irza Pharmaceuticals. Reg. No. 85210
GMP status The firm submitted GMP inspection report dated
15.03.2019, which conclude that the firm had maintained
conformance to GMP compliance.
 The firm was asked to submit updated (26 points),
duly filled and signed Form 5. The firm submitted
34 points Form 5
Decision: Approved with innovator's specifications.
825. Name and address of manufacturer/ M/s Searle IV Solutions Pvt Ltd.
Applicant 1.5 km, Manga Raiwind Road, Lahore
Brand Name + Dosage Form + Spasnil 40/0.04 mg Injection
Strength
Hydrated Phloroglucinol…40mg
Trimethylphloroglucinol…0.04mg
PKR. 20,000/-; 30.11.2018
Type of Form Form 5
Approval status of product in SPASFON, solution injectable en ampoule (4ml). ANSM
Me-too status Spadix Injection. Reg. No. 29528
GMP status The firm submitted GMP inspection report dated
15.03.2019, which conclude that the firm had maintained
conformance to GMP compliance.
Remarks of the Evaluator(IX)  The firm was asked to submit updated (26 points),
duly filled and signed Form 5. The firm submitted
34 points Form 5.
Decision: Approved with innovator's specifications.
826. Name and address of manufacturer / M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd Plot # 50/28
Applicant Korangi Industrial Area Karachi
Brand Name +Dosage Form + Strength Cekosil Cream 1%
Composition Each gram of cream contains;
Terbinafine hydrochloride…10mg
Diary No. Date of R& I & fee Dy. No. 40314:: 05.12.2018. Rs. 20,000: 04.12.2018
Pharmacological Group Other antifungals for topical use
Type of Form Form-5
Finished Product Specification JP
Pack size & Demanded Price 10g: As per SRO
Approval status of product in Reference LAMISIL 1% w/w Cream. USFDA Approved
Me-too status Terbiderm Cream 1% (Reg#032004)
GP status Last GMP inspection of M/s. CKD Pharmaceuticals was
conducted on 04-09-2018, where in the compliance level of
the firm was rated Good.
Remarks of the Evaluator(IX). Name of signatory is missing on Form 5.
Decision: Approved.

Brand Name +Dosage Form + Strength Cekosil Gel 1% (w/w)
Each gram contains:
Composition Terbinafine hydrochloride…1.0%
Diary No. Date of R& I & fee Dy. No. 40315: 05.12.2018 Rs.20,000/-:: 04.12.2018
Pharmacological Group Other antifungals for topical use
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 10g, : As per SRO
Approval status of product in Reference Lamisil AT 1% Gel. MHRA approved
Me-too status Cutis Gel 1%. Reg. No. 58518
Decision: Approved.
Brand Name +Dosage Form + Strength Perme-Lice Cream 5%
Permethrin ……………….50mg
Diary No. Date of R& I & fee Dy. No. 40310: 05.12.2018 Rs.20,000/- : 04.12.2018
Pharmacological Group Pyrethrines, incl. synthetic compounds
Type of Form Form-5
Finished Product Specification Innovator’s specifications.
Pack size & Demanded Price 30g ; As per SRO
Approval status of product in Reference Permethrin 5% w/w Cream. MHRA Approved
Me-too status Bioscab Cream (Reg#.074773)
Decision: Approved.
Brand Name +Dosage Form + Strength Perme-Lice Lotion 5% w/v
Permethrin ……5%
Diary No. Date of R& I & fee Dy.No. 40311: 05.12.2018. Rs. 20,000: 04.12.2018
Pharmacological Group Pyrethrines, incl. synthetic compounds
Type of Form Form-5
Finished Product Specification Innovator’s specifications.
Pack size & Demanded Price 60ml, 120ml: As per SRO
Me-too status Permilot Lotion 5% (w/v). Reg # 076033

Proof of international availability of same formulation and
same strength in reference regulatory authorities as defined
in 275th meeting of the registration board is required.
Decision: Approved.
Brand Name +Dosage Form + Strength Flucon capsule 150mg
Fluconazole……150mg
Diary No. Date of R& I & fee Dy. No. 40307: 05.12.2018. Rs. 20,000: 04.12.2018
Type of Form Form-5
Pack size & Demanded Price 1’s & 1x4’s: As per SRO
Approval status of product in Reference Fluconazole 150mg Capsules. MHRA approved
Me-too status Conza Capsule. Reg. No. 84049
Decision: Approved.
Brand Name +Dosage Form + Strength Eflo Cream
Composition Each gram of tube contains:
Eflornithine as HCl Monohydrate...139 mg (13.9%)
Diary No. Date of R& I & fee Dy.No Rs. 20,000: 04.12.2018
Pharmacological Group Other agents against leishmaniasis and trypanosomiasis
Type of Form Form-5
Pack size & Demanded Price 1’s (15g); As per SRO
Approval status of product in Reference VANIQA eflornithine hydrochloride 139mg/g cream tube.
Me-too status Depilus Cream 13.9% Reg. # 073869 (does not depict
hydrate form).
Decision: Approved.
Brand Name +Dosage Form + Strength Isot Gel 0.05% w/w
Isotretinoin…0.5mg
Diary No. Date of R& I & fee Dy.No 40308: 05.12.2018 Rs. 20,000: 04.12.2018
Type of Form Form-5
Finished Product Specification The firm has claimed in-house specifications
Approval status of product in Reference Isotrex gel 0.05% w/w. MHRA Approved
Me-too status Iso-Scot Gel 0.05%. Reg # 37706
GP status

Last GMP inspection of M/s. CKD Pharmaceuticals was
Decision: Approved.
Brand Name +Dosage Form + Strength Ckolynz Tablet 400mg

Linezolid ………….. …..400mg
Type of Form Form-5
Finished Product Specification Innovator’s Specification.
Pack size & Demanded Price 1x 10’s, 2x6’s, 3x4’s; As per SRO
Approval status of product in Reference ZYVOX® (linezolid) tablets (film-coated) for oral use. not
Regulatory Authorities. discontinued or withdrawn by US-FDA for safety or
efficacy reasons
Me-too status Enliv 400mg Tablet. Reg No. 58096 (does not depict
coating)
Remarks of the Evaluator(IX) Name of signatory is missing on Form 5.
Decision: Approved.
Brand Name +Dosage Form + Strength Ckolynz Tablet 600mg
Linezolid ………….. …..600mg
Type of Form Form-5
Pack size & Demanded Price 1x 10’s, 2x6’s, 3x4’s; As per SRO
Approval status of product in Reference ZYVOX® (linezolid) tablets (film-coated) for oral use. not
Regulatory Authorities discontinued or withdrawn by US-FDA for safety or
efficacy reasons
Me-too status Linstar 600mg Tablet. Reg No. 82689
Decision: Approved.
Brand Name +Dosage Form + Strength Genta-Bet Cream
Composition Each gram contains
Betmethasone as dipropionate…..0.05% w/w.
Gentamycin as sulphate……..0.1% w/w
Pharmacological Group Aminoglycosides and glucocorticoids
Type of Form Form-5
Approval status of product in Reference Diprogenta Cream. Approved in Germany
Regulatory Authorities. ASK no. Substance name Amount of substance
Gentamicin sulfate 1.67mg
Betamethasone Dipropionate (Ph.Eur.) 0.64mg
Me-too status Effigenta Cream. Reg. No. 024375
Remarks of the Evaluator(IX). Name of signatory is missing on Form 5
Decision: Approved.
Brand Name +Dosage Form + Strength Genta-Bet Ointment
Composition Each gram contains
Betmethasone as Dipropionate…..0.05% w/w
Gentamycin as Sulphate…….0.1% w/w
Diary No. Date of R& I & fee Dy. No 40313: 05.12.2018. Rs. 20,000: 04.12.2018
Pharmacological Group Aminoglycosides and glucocorticoids
Type of Form Form-5
Approval status of product in Reference Diprogenta ointment. Approved in Germany
Regulatory Authorities. ASK no. Substance name Amount of substance
Gentamicin sulfate 1.67mg
Betamethasone Dipropionate (Ph.Eur.) 0.64mg
Me-too status Effigenta Ointment. Reg. No. 024376

Decision: Approved.
Brand Name +Dosage Form + Strength Rivax 10mg Tablet
Rivaroxaban……………...10mg
Diary No. Date of R& I & fee Dy.No. 40322: 05.12.2018. Rs. 20,000: 04.12.2018
Type of Form Form-5
Pack size & Demanded Price 1x5’s, 1x10’s, 1x14’s, 1x20’s; As per SRO
Approval status of product in Reference Rivaroxaban 10 mg film-coated. MHRA approved
Me-too status Xaroban 10mg Tablet. Reg. No. 76284
Decision: Approved.
Rivaroxaban……………...15mg
Type of Form Form-5
Pack size & Demanded Price 1x5’s, 1x10’s, 1x14’s, 1x20’s; As per SRO
Approval status of product in Reference Rivaroxaban 15 mg film-coated tablets. MHRA approved
Me-too status Rivaxo 15mg film-coated Tablet. Reg. No. 80790
Decision: Approved.
Rivaroxaban……………... 20mg
Type of Form Form-5
Pack size & Demanded Price 1x10’s, 1x20’s, 1x14’s; As per SRO
Approval status of product in Reference Xarelto 20mg Tablet of (USFDA approved)
Me-too status Xerelto 20mg Tablet by Bayer Pakistan (Reg. No. 072550)
Decision: Approved.
Brand Name +Dosage Form + Strength Ivab 5mg Tablet
Ivabradine as hydrochloride …5mg
Pharmacological Group Other cardiac preparations
Type of Form Form-5
Pack size & Demanded Price 1x4’s, 4x14’s; As per SRO
Approval status of product in Reference CORLANOR film-coated tablets, for oral use. USFDA
Me-too status Ivatab 5mg Tablet. Reg. No. 76154
Decision: Approved.
Brand Name +Dosage Form + Strength Ivab 7.5mg Tablet
Ivabradine as hydrochloride …7.5mg
Pharmacological Group Other cardiac preparations

Type of Form Form-5
Pack size & Demanded Price 1x4’s, 4x14’s; As per SRO
Approval status of product in Reference CORLANOR film-coated tablets, for oral use. USFDA
Me-too status Ivatab 7.5mg Tablet. Reg. No. 76155
Decision: Approved.
Brand Name +Dosage Form + Strength Loxicam 4mg tablet
Composition Each film coated tablet contains
Lornoxicam….. 4 mg
Type of Form Form 5
Pack size & Demanded Price 10’s As per SRO
Approval status of product in Reference Xefo 4 mg Filmtabletten (Swiss Medic approved)
Me-too status Noxilor Tablet. Reg. No. 84039
Remarks of the Evaluator(IX).
Decision: Approved.
Brand Name +Dosage Form + Strength Loxicam 8mg tablet
Lornoxicam….. 8mg
Type of Form Form 5
Pack size & Demanded Price 5’s, 10’s & 30’s As per SRO
Remarks of the Evaluator(IX).
Decision: Approved.
b. Deferred cases
844. Name and address of manufacturer M/s Sigma pharma International Pvt Ltd.
/ Applicant Plot # E-50, North Western Industrial Zone, Bin Qasim,
Karachi, Pakistan
Brand Name +Dosage Form + Ftaft EC 500mg Tablet
Strength

Naproxen…500mg
PKR 20,000/-: 03.07.2018
Pharmacological Group Propionic acid derivatives.
Type of Form Form 5
Pack size & Demanded Price 20’s; As per DRAP policy
Approval status of product in Naproxen 500 mg Gastro-resistant Tablets. MHRA approved
Me-too status Naps 500mg Tablet. Reg. No. 83344
inspection dated 15.09.2017.
Remarks of the Evaluator (IX).  The applicant/signatory’s name was missing in Form 5. The
firm submitted revised form 5. Name of signatory is missing
at first place in Form 5; mentioned along with signature
 The firm mentioned term EC in the brand name and applied
for enteric coated tablet. Upon clarification, the firm
submitted label claim as “Each enteric coated tablet
contains”. However, no coating compostion and coating
process has been submitted.
Previous decision The Board in its 291st meeting deferred the case for submission
of correct master formula and manufacturing outlines.
Evaluation by PEC The firm submitted revised Master formula and manufacturing
outlines.
Form 5 has been signed by manager regulatory affairs.
 Decision: Approved.
845. Name and address of manufacturer Sigma Pharma International (Pvt) Ltd., Plot # E-50, North
/ Applicant Western Industrial Zone, Bin Qasim, Karachi, Pakistan
Brand Name +Dosage Form + Masaco Tablet 800mg
Strength
Composition Each dealyed release tablet contains:
Mesalazine…….800mg
PKR 20,000/-: 23.02.2018
Type of Form Form 5
Pack size & Demanded Price As per DRAP Policy
Approval status of product in ASACOL® HD (mesalamine) delayed-release tablets, for oral
Reference Regulatory Authorities. use. MHRA approved
Octasa 800 mg Modified Release Tablets. MHRA approved
Me-too status Pressurex 20mg film-coated Tablets. Reg. No. 67535
GMP status The firm has been granted GMP certificate on the basis of
Remarks of the Evaluator(IX).  The firm has mentioned film-coated tablet with seal coat and
modified release coat. Upon clarification, the firm revised the
coating to enteric coating without fee. However, the reference
product has an outer protective coat consisting of a
combination of acrylic based resins, Eudragit S (methacrylic
acid and methyl methacrylate copolymer (1:2), NF) and
Eudragit L (methacrylic acid and methyl methacrylate
copolymer (1:1), NF). The inner coat consists of an acrylic
based resin, Eudragit S, which dissolves at pH 7 or greater,
releasing mesalamine in the terminal ileum and beyond for
topical antiinflammatory action in the colon.

Previous decision The Board in its 289th meeting deferred the case for clarification
from the firm.
Evaluation by PEC  The firm submitted revised Master formula and
 The firm initially applied for modified release tablet. The
firm revised the label claim to delayed release tablet, then
to modified release tablet and finally to delayed release
tablet.
 Decision: Deferrred for submission of fee of Rs. 20,000/- for revision of label claim as per reference
product.
846. Name and address of manufacturer Sigma Pharma International (Pvt) Ltd., Plot # E-50, North
/ Applicant Western Industrial Zone, Bin Qasim, Karachi, Pakistan
Brand Name +Dosage Form + Mesaco Tablet 400mg
Strength
Composition Each delayed release tablet contains:
Mesalazine…….400mg
PKR 20,000/-: 23.02.2018
Type of Form Form 5
Approval status of product in ASACOL® HD (mesalamine) delayed-release tablets, for oral
Reference Regulatory Authorities. use. MHRA approved
Octasa 400 mg Modified Release Tablets. MHRA approved
Me-too status Coltab Tablet 400mg. Reg. No. 41652
GMP status The firm has been granted GMP certificate on the basis of
Remarks of the Evaluator(IX).  The firm has mentioned film-coated tablet with seal coat and
modified release coat. Upon clarification, the firm revised the
coating to enteric coating without fee. However, the reference
product has an outer protective coat consisting of a
combination of acrylic based resins, Eudragit S (methacrylic
acid and methyl methacrylate copolymer (1:2), NF) and
Eudragit L (methacrylic acid and methyl methacrylate
copolymer (1:1), NF). The inner coat consists of an acrylic
based resin, Eudragit S, which dissolves at pH 7 or greater,
releasing mesalamine in the terminal ileum and beyond for
topical antiinflammatory action in the colon.
Previous decision The Board in its 289th meeting deferred the case for clarification
from the firm.
Evaluation by PEC  The firm submitted revised Master formula and
 The firm initially applied for modified release tablet. The
firm revised the label claim to delayed release tablet, then
to modified release tablet and finally to delayed release
tablet.
 Decision: Deferrred for submission of fee of Rs. 20,000/- for revision of label claim as per reference
product.
847. Name and address of manufacturer/ M/s Pakistan Pharmaceutical Products Pvt Ltd. D-122, Sindh
Applicant Industrial Trading Estate, Karachi
Brand Name + Dosage Form + Arcoxone 2gm Injection IV
Strength
Ceftriaxone as sodium…2g
PKR. 20,000/-; 10.09.2018
Type of Form Form 5
Pack size & Demanded Price As per PCA
Approval status of product in Ceftriaxone 2 g powder for solution for injection/infusion.
Reference Regulatory Authorities MHRA approved
Me-too status Cefast 2g Injection I.V. Reg. No. 82281

Remarks of the Evaluator(IX) Submit clear and complete manufacturing outlines, including
sterile filling/terminal sterilization and packing process
Previous decision The Board in its 293rd meeting deferred the case for submission
of clear and complete manufacturing outlines, including sterile
filling/terminal sterilization and packing process.
Evaluation by PEC The firm submitted revised manufacturing outlines.
Decision: Approved.
848. Name and address of manufacturer M/s Medizan Laboratories (Pvt) Ltd Plot no. 313,
/Applicant Industrial Triangle Kahuta Road Islamabad, Pakistan.
Brand Name +Dosage Form + PARACORD TABLETS
Strength
Composition Each tablet contains:-
Paracetamol…..500mg
Codeine phosphate ………..15mg
Diary No. Date of R & I & fee Dy.No. 16281: 07-03-2019
Rs. 20,000/- dated 07-03-2019
Pharmacological Group Analgesics
Type of Form Form-5
Pack size & Demanded Price 30’s, Price as per SRO
Approval status of product in Co-codamol (8mg/500 mg, 15mg/500 mg, 30mg/500 mg)
Reference Regulatory Authorities. Tablets. MHRA Approved
Me-too status CODOGESIC 15mg/500 mg tablet. Reg. No.: 028956
GMP status New section
Remarks of the Evaluator(IX)  The reference product contains Codeine phosphate
hemihydrate ….15mg without equivalency.
Correction is required.
Previous decision The Board in its 294th meeting deferred the case for revision of
label claim as per reference product along with submission of
requisite fee.
Evaluation by PEC The firm submitted Codeine phosphate….15mg instead of
Codeine phosphate hemihydrate ….15mg with submission of
Rs. 5000/- fee.
Decision: Deferred for revision of label claim from Codeine phosphate….15mg to Codeine
phosphate hemihydrate ….15mg.
849. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd. 19 Km Sheikhupura
Applicant Road, Faisalabad; contract manufacturing by
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km, Ferozepur
Road, Lahore
Brand Name +Dosage Form + BeCef 100mg/5ml Suspension
Strength
Composition Each 5ml Reconstituted Suspension Contains:
Cefixime Trihydrate Eq. to Cefixime…100mg
Diary No. Date of R& I & fee Dy. No. 32778; 03-10-2018,
PKR: 50,000/-; 03-10-2018
Type of Form Form 5
th
Pack size & Demanded Price 30ml; As per DRAP Policy
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension. MHRA
GMP status Applicant: The firm was inspected on 22.01.2019. The panel
reported good level of GMP compliance.
Manufacturer: The firm was inspected on 5-6.12.2017, wherein
the firm was reported to be GMP compliant.
(IX)
Remarks of the Evaluator .  The firm did not submit list of approved products of
applicant for contract manufacturing.
 The firm did not submit list of all approved sections of
applicant.
Previous decision The Board in its 293rd meeting deferred the case for the
following:
 Submission of list of approved products of applicant for
 Submission of list of approved sections.
 Capacity assessment of M/s Novamed as decided earlier by
Registration Board
Evaluation by PEC  The firm submitted list of 14 sections.
 The firm submitted that they have no contract
manufacturing agreement with any other firm.
Decision: Approved.
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km,Ferozepur
Road, Lahore
Brand Name +Dosage Form + BeCef 200mg/5ml Suspension
Strength
Composition Each 5ml Reconstituted Suspension Contains:
Diary No. Date of R& I & fee Dy. No. 32779; 03-10-2018
PKR: 50,000/-; 03-10-2018
Type of Form Form 5
Pack size & Demanded Price 30ml; As per DRAP Policy
Approval status of product in SUPRAX® (cefixime) for oral suspension. USFDA approved
Remarks of the Evaluator(IX).  The firm did not submit list of approved products of
applicant.
following:
Registration Board
Decision: Approved.
Road, Lahore
Brand Name +Dosage Form + BeCef 200mg Capsule
Strength
PKR: 50,000/-; 03-10-2018
Type of Form Form 5
Pack size & Demanded Price 5’s, 10’s; As per DRAP Policy
Approval status of product in CEFIXIMA NORMON 200 mg HARD CAPSULES EFG.
Reference Regulatory Authorities. CIMA approved
Me-too status CEFIXIMA NORMON 200 mg HARD CAPSULES EFG. Reg.
No. 34664
(IX)
Remarks of the Evaluator .  The firm did not submit list of approved products of
applicant.
following:
Registration Board
Decision: Approved.
Road, Lahore
Brand Name +Dosage Form + BeCef 400mg Capsule
Strength
PKR: 50,000/-; 02-10-2018
th
Type of Form Form 5
Pack size & Demanded Price 5’s; As per DRAP Policy
Approval status of product in SUPRAX® (cefixime) 400mg capsules, for oral. Approved by
Reference Regulatory Authorities. US-FDA
Me-too status Nowcef 400mg Capsule. Reg. No. 82219
Remarks of the Evaluator(IX).  The firm did not submit list of approved products of
applicant.
 First page of Form 5 has not been signed.
 Revise “Cefixime Trihydrate Eq. to Cefixime” to
“Cefixime Trihydrate” in Master formula only
following:
Registration Board
Decision: Approved.
853. Name and address of manufacturer M/s Vision Pharmaceuticals. Plot # 22,23, Industrial
/ Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Mensodol Tablet 500/25mg
Strength
Paracetamol…500mg
Pamabrom…25mg
PKR 20,000/-: 26.04.2018
Pharmacological Group Anilides + Pamabrom (not in ATC)
Type of Form Form 5
Finished Product Specification The firm has claimed manufacturer’s specifications.
Approval status of product in Back Aid Max, OTC product) which is available at:
Reference Regulatory Authorities. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb9a
5647-b7c9-4820-b148-91060e34cb83
Me-too status Women’s Tylol Caplets. Reg. No. 62787
GMP status The firm was inspected on 11.02.2019, wherein the panel
recommended the grant of GMP certificate.
Remarks of the Evaluator(IX)  Form 5 is different in some points from the approved one.
 Justification is required about 3% excess.
 Provide proof of International availability of same
formulation with same strength in reference regulatory
authority as defined in 275th meeting of the Registration
Board.

 The label claim in Form 5 is “Each tablet contains”. However,
coating composition have been mentioned in Master Formula.
Justify/clarify.
Previous decision The Board in its 289th meeting deferred the case the following:
 Justification is required about 3% excess.
 Proof of International availability of same formulation
with same strength in reference regulatory authority as
defined in 275th meeting of the Registration Board.
 The label claim in Form 5 is “Each tablet contains”.
However, coating composition have been mentioned in
Master Formula. Justify/clarify.
Evaluation by PEC  The firm submitted that the overage was mentioned
mistakenly.
 The firm submitted that the label claim is film-coated
tablet.
 Proof of International availability of same formulation
with same strength in reference regulatory authority as
defined in 275th meeting of the Registration Board.
Previous decision  The Board in its 292nd meeting deferred the case for Proof
of International availability of same formulation with same
strength in reference regulatory authority as defined in
275th meeting of the Registration Board.
Evaluation by PEC  The firm provided reference of “Back Aid Max, OTC
product) which could be confirmed.
Previous decision  The Board in its 295th meeting deferred the case for proof
of International availability of same formulation with same
strength in reference regulatory authority as defined in
275th meeting of the Registration Board.
Evaluation by PEC  The firm provided reference of “Back Aid Max, OTC
product) which is available at:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?seti
d=fb9a5647-b7c9-4820-b148-91060e34cb83
854. Name and address of manufacturer/ M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Brand Name + Dosage Form + Glytide 200mg Injection
Strength
Teicoplanin…200mg
PKR. 20,000/-; 01.10.2018
Type of Form Form 5
Pack size & Demanded Price 1’s (glass vial); As per policy of MoH
Approval status of product in Teicoplanin 200 mg, powder for solution for injection/infusion
Reference Regulatory Authorities or oral solution. MHRA approved
Me-too status Planin 200mg Injection. Reg. No. 55188

GMP status As above
Previous decision  The Board in its 293rd meeting deferred the case for
Deferred for confirmation of manufacturing process
(powder filling or lyophilization) and requisite facility.

Evaluation by PEC  The firm submitted revised manufacturing outlines,
which depicts that the product is manufactured by the
process of lyophilisation.
855. Name and address of manufacturer/ M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
Brand Name + Dosage Form + Glytide 400mg Injection
Strength
Teicoplanin…400mg
PKR. 20,000/-; 01.10.2018
Type of Form Form 5
Pack size & Demanded Price 1’s (glass vial); As per policy of MoH
Approval status of product in Teicoplanin 400 mg, powder for solution for injection/infusion
Reference Regulatory Authorities or oral solution. MHRA approved
TARGOCID teicoplanin 400mg lyophilized powder for
injection vial with diluent ampoule. TGA approved.
Me-too status Asist 400mg Injection. Reg. No. 50694
GMP status As above
Remarks of the Evaluator(IX)  First page of Form 5 has been signed by quality control
manager.
Previous decision  The Board in its 293rd meeting deferred the case for
confirmation of manufacturing process (powder filling
or lyophilization) and requisite facility.
Evaluation by PEC  The firm submitted revised manufacturing outlines,
which depeicts that the product is manufactured by the
process of lyophilisation.
856. Name and address of manufacturer M/s Mediate Pharmaceutical Pvt Ltd. Plot No. 150-151,
/ Applicant Sector 24, Korangi Industrial Area, Karachi, Pakistan
Brand Name +Dosage Form + Vildamed 50/850 mg Tablet
Strength
Vildagliptin…50mg
Metformin HCl…850mg
PKR 20,000/-: 25.05.2018
Type of Form Form 5
Finished Product Specification The firm has claimed Manufacturer’s specifications
Approval status of product in GALVUMET 50/850 vildagliptin 50 mg/metformin
Reference Regulatory Authorities. hydrochloride 850 mg film coated tablet. TGA approved
Me-too status GALVUS MET 50MG/850MG TABLETS. Reg. No. 66106
GMP status The firm was inspected on 15.02.2017 wherein the firm was
considered to be operating at acceptable level of compliance with
GMP guidelines.
Remarks of the Evaluator(IX).  The shelf-life of reference product in TGA is 18 months.
 The name of signatory is not present on the form 5.
Pervious decision The Board in its 291st meeting deferred the case for revision of
salt form in line with the reference product along with
Evaluation by PEC  The firm has revised metformin to Metformin HCl along
with submission of Rs. 5000/- fee.
th
Revision of Form5 and Master Formula is still
required.
Pervious decision  The Board in its 293rd meeting deferred the case for salt
form in Form5 and Master Formula.
Evaluation by PEC  The firm revised salt form in Form5 and Master Formula.
Decision: Approved with innovator’s specification and 18 months shelf life.
857. Name and address of manufacturer M/s Alen Pharmaceuticals (Pvt) Ltd. 138-A, Nowshehra
/ Applicant Industrial Estate, Risalpur, KPK. By M/s Welwrd
Pharmaceuticals. Plot # 3, Block A, Phase I-II, Industrial
Estate Hattar, KPK
Brand Name +Dosage Form + S-Alen 40mg Infusion
Strength
Esomeprazole as sodium……40mg
PKR 50,000/-: 10.08.2018
Type of Form Form 5
Finished Product Specification The firm has claimed innovator’s specifications
Pack size & Demanded Price as fixed by Govt
Approval status of product in NEXIUM IV esomeprazole 40mg (as sodium) powder for
Reference Regulatory Authorities. injection vial. TGA approved
Me-too status Somezol Injection. Reg. No. 45386
GMP status Applicant: Alen Pharma: Suspension of Production activities in
all Sections on 15.01.2020.
Manufactuer: Inspection of M/s Welwrd Pharmaceuticals 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.
The firm M/s Alen Pharma was inspected on 31.05.2018, where
no conclusion has been made thereof.
Remarks of the Evaluator(IX).  The firm revised the address to M/s Alen Pharmaceuticals
(Pvt) Ltd. 138-A, Nowshehra Industrial Estate, Risalpur,
KPK.
 Scanned signatures are placed in the Undertaking at the end
of Form 5.
 The salt form was correct in master Formula. However, the
firm revised ‘Esomeprazole’ to ‘Esomeprazole as sodium’
in label claim.
 List of already approved product for contract manufacturing
of M/s Alen Pharmaceuticals Pvt Ltd is required.
 List of applied product for contract manufacturing of M/s
Alen Pharmaceuticals Pvt Ltd is required.
 List of approved sections of M/s Alen Pharmaceuticals Pvt
Ltd is required.
Pervious decision The Board in its 293rd meeting deferred the case for:
 Submission of list of approved sections of M/s Alen
Pharma.
th
List of applied products for contract manufacturing of M/s
Alen Pharma.
 Submission of fee for revising the label claim of the applied
product.
Evaluation by PEC The firm submitted:
 List of 04 approved sections
 List of 03 approved products
 List of 17 applied products
 Rs. 5000/- fee.
 Decision: Deferred for DML status of M/s Alen Pharmaceuticals Pvt Ltd. Risalpur.
858. Name and address of M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
manufacturer/Applicant National Industrial Zone, Rawat, Islamabad, Pakistan
Brand Name + Dosage Form + Opidol 100mg/2ml Injection
Strength
Composition Each 2ml ampule contains:
Tramadol hydrochloride….100mg
Diary No. Date of R & I & Fee Dy No. 15610: 07.03.2019
Rs. 20,000/-: 07.03.2019
Pharmacological Group Other opioids
Type of Form Form-5
Pack Size & Demanded Price 2mlx10’s;, 2mlx30’s; as per SRO
Approval Status of product in Tramadol 50mg/ml Solution for Injection or Infusion (2ml).
Reference Regulatory Authorities MHRA approved
Me-too Status Welmadol Injection (2ml). Reg. No. 52629 (deos not show
ampule or vial)
GMP Status The firm was inspected on 22.06.2020 with the following
conclusion:
In light of above the firm can be rated as complying GMP
standards as per Schedule B-II of Drugs (LR&A) Rules, 1976.
However, cGMP is a continual process of improvement for
which the above stated points of improvement have been agreed
upon by the management.
Pervious decision The Board in its 289th meeting deferred the case for
consideration on its turn as neither Narcotic or Psychotropic as
per INCB
859. Name and address of M/s Iqra Pharmaceuticals. Plot No. 02, Street No. S-9,
manufacturer / Applicant National Industrial Zone, Rawat, Islamabad, Pakistan
Brand Name + Dosage Form + Nilbo 10mg/ml Injection
Strength
Nalbuphine hydrochloride….10mg
Diary No. Date of R & I & Fee Dy No. 15609: 07.03.2019
Rs. 20,000/-: 07.03.2019
Pharmacological Group Morphinan derivatives
Type of Form Form-5
Finished Product Specification The firm has claimed manufactuer’s specifications.
Pack Size & Demanded Price 2x5 ampule PVC contour cellular package 1 contour cellular in
a carton box.
Approval Status of product in NUBAIN (Nalbuphine Hydrochloride) Injection, 10 mg/mL
Reference Regulatory Authorities (1ml ampule). Health Canada approved
Me-too Status Nalburax Injection. Reg. No. 28830 (deos not show ampule or
vial)

GMP Status The firm was inspected on 22.06.2020 with the following
conclusion:
In light of above the firm can be rated as complying GMP
standards as per Schedule B-II of Drugs (LR&A) Rules, 1976.
However, cGMP is a continual process of improvement for
which the above stated points of improvement have been agreed
upon by the management.
Remarks of the Evaluator(IX)  Clarification is required about the pack size.
Pervious decision The Board in its 289th meeting deferred the case for
consideration on its turn as neither Narcotic or Psychotropic as
per INCB
860. Name and address of manufacturer / M/s Palpex Pharmaceuticals Pvt Ltd. FD-46-A8, ST-1,
Applicant Sector 38, Korangi Creek Industrial Park, Karachi,
Pakistan
Brand Name +Dosage Form + Strength Propex 1g/100ml Infusion
Acetaminophen…1g
PKR 20,000/-: 11.09.2018
Pharmacological Group Anilides
Type of Form Form 5
Approval status of product in Reference MHRA approved.
Me-too status Provas Infusion 10mg/ml. No. 53223 (filled volume not
specified)
GMP status GMP Certificate issued on 08.05.2018.
Remarks of the Evaluator(IX).  Form 5 was not submitted. The firm submitted Form 5
on 30.09.2019. Name of signatory is missing on Form 5.
Previous decision The Board in its 293rd meeting deferred the case for
completion of Form 5.
Evaluation by PEC The firm submitted Form 5. Undertaking at the end of Form
is missing.
Previous decision The Board in its 295th meeting deferred the case for
submission of undertaking of Form-5.
Evaluation by PEC The firm submitted undertaking at the end of Form.
Decision: Approved.
Pakistan
Brand Name +Dosage Form + Strength Droxipal 125mg/5ml Dry Suspension
Cefadroxil Monohydrate Eq. to Cefadroxil…125mg
PKR 20,000/-: 11.09.2018
Pharmacological Group First-generation cephalosporins
Type of Form Form 5
Approval status of product in Reference Biodroxil 125 mg /5 ml - Pulver zur Herstellung einer
Regulatory Authorities. Suspension zum Einnehmen (Biodroxil 125 mg / 5 ml -
Powder for oral suspension). AGES approved
Me-too status Evacef Suspension 125mg. Reg. No. 11213

 The firm has mentioned granulation process in the
manufacturing outlines. Justification that the
international reference product is the form of granule for
suspension, was asked from the firm. The firm did not
justify.
clarification/submission of the manufacturing outline in line
with the reference product.
Evaluation by PEC The firm submitted biodroxil as reference product and stated
that the product mentioned that it is granule for suspension.
The said product could not be verified.
submission of manufacturing outline in line with reference
product
Evaluation by PEC The matter shall be deliberated by the Board regarding the
granule or powder for suspension and fee thereof.
Decision: Deferred for further deliberation regarding formulation in line with reference product.
Pakistan
Brand Name +Dosage Form + Strength Droxipal 250mg/5ml Dry Suspension
PKR 20,000/-: 11.09.2018
Type of Form Form 5
Approval status of product in Reference Cefadroxil 250 mg/5 ml powder for oral suspension.
Regulatory Authorities. USFDA approved.
Cefadroxil 250 mg/5 ml granules for oral suspension.
MHRA approved
Me-too status Evacef Suspension 250mg. Reg. No. 11214
Remarks of the Evaluator(IX). Form 5 has not been submitted.
submission of Form 5.
Evaluation by PEC The firm submitted Form 5. Undertaking at the end of form is
missing.
Decision: Deferred for further deliberation regarding formulation in line with reference product.
Pakistan
Brand Name +Dosage Form + Strength Droxipal 500mg Capsule
PKR 20,000/-: 11.09.2018

Type of Form Form 5
Approval status of product in Reference Cefadroxil 500 mg Capsules. MHRA approved
Me-too status Sokxil 500mg Capsules. Reg. NO. 54925
 The firm has mentioned granulation process in the
manufacturing outlines. Justification that the
international reference product is the form of granule for
suspension, was asked from the firm. The firm did not
justify.
 Evidence of me-too product (name and registration
number) approved by DRAP is required.
Previous decision The Borad in its 293rd meeting deferred the case for the
following:
 Clarification/submission of the manufacturing outline
inline with the reference product.
by DRAP (generic / me-too status) along with
Evaluation by PEC The firm has applied for Droxipal 500mg Capsule, however,
the case was mistakenly presented as Droxipal 500mg/5ml
suspension.
Decision: Approved.
Pakistan
Brand Name +Dosage Form + Strength Famopal 20mg Tablet
Famotidine…20mg
PKR 20,000/-: 11.09.2018
Pharmacological Group H2-receptor antagonists
Type of Form Form-5
Approval status of product in Reference AUSFAM famotidine 20mg and 40mg tablet, film-coated
Regulatory Authorities. blister pack. TGA approved
Me-too status Welcid-20mg Tablet film-coated. Reg. No. 81681
Remarks of the Evaluator(IX).  Form 5 has not been submitted.
 You have mentioned methylene chloride in the coating
composition. Justify its safety.
following:
 Submission of form 5.
 Use of banned excipient that is methylene chloride in
coating.
Evaluation by PEC The firm submitted Form 5. Undertaking at the end of Form 5
is missing.
The firm revised the coating composition.
Decision: Approved.
Pakistan
Brand Name +Dosage Form + Strength Famopal 40mg Tablet
Famotidine…40mg
PKR 20,000/-: 11.09.2018
Pharmacological Group H2-receptor antagonists
Type of Form Form-5
Approval status of product in Reference AUSFAM famotidine 20mg and 40mg tablet, film-coated
Regulatory Authorities. blister pack. TGA approved
Me-too status Famitol 40mg Tablet film-coated. Reg. No. 85770
Remarks of the Evaluator(IX).  Form 5 has not been submitted.
 You have mentioned methylene chloride in the coating
composition. Justify its safety.
following:
 Submission of form 5.
 Use of banned excipient that is methylene chloride in
coating.
Evaluation by PEC The firm submitted Form 5. Undertaking at the end of Form 5
is missing.
The firm revised the coating composition.
Decision: Approved.
866. Name and address of manufacturer/ M/s Pharmix Laboratories Pvt Ltd. 21 Km, Ferozepur Road,
Applicant Lahore
Brand Name + Dosage Form + Strength Solicin 5mg Tablet
Solifenacin succinate…5mg
PKR. 20,000/-; 11.01.2019
Type of Form Form 5
Approval status of product in Reference VESIcare (solifenacin succinate) film-coated 5mgtablets.
Me-too status Solfine film-coated Tablet 5mg. Reg No. 81958
GMP status The firm was inspected on 13.09.2019 the following
recommendations:
The panel of inspector recommends the renewal of M/s
Pharmix Laboratories Pvt Ltd. Located at 21 Km, Ferozepur
Road, Lahore bearing DML No. 000397 subject to verification
of all approved sections by the licensing division, DRAP,
Islamabad.
Remarks of the Evaluator(IX)  The firm was asked to submit properly filled
enclosure of Form 5 (26 points) along with signed

undertaking at the end of Form 5. The firm submitted
undertaking only.
submission of complete Form 5.
Evaluation by PEC  The firm submitted complete enclosure of Form 5.
Applicant Lahore
Brand Name + Dosage Form + Strength Solicin 10mg Tablet
Solifenacin succinate…10mg
PKR. 20,000/-; 11.01.2019
Type of Form Form 5
Approval status of product in Reference VESIcare (solifenacin succinate) film-coated 10mg tablets.
Me-too status Solfine film-coated Tablet 10mg. Reg No. 81959
GMP status As for above case
undertaking only.
Applicant Lahore
Brand Name + Dosage Form + Strength Prelin 50mg Capsule
Pregabalin…50mg
PKR. 20,000/-; 11.01.2019
Type of Form Form 5
Approval status of product in Reference Alzain 50 mg Capsules, Hard. MHRA approved
Me-too status Scirica 50mg Capsule. Reg. No. 82187
undertaking only.
Applicant Lahore
Brand Name + Dosage Form + Strength Alcox 60mg Tablet

Etoricoxib…60mg
PKR. 20,000/-; 31.01.2019
Type of Form Form 5
Approval status of product in Reference ARCOXIA etoricoxib 60mg film-coated tablet. TGA
Me-too status Gencox 60mg Tablets film-coated. Reg. No. 78839
undertaking only.
870. Name and address of manufacturer / Relizon Pharmaceuticals, 118, Sunder Industrial Estate,
Applicant Lahore
Brand Name +Dosage Form + Strength Pantozon Tablet 40mg
Pantoprazole (as sodium sesquihydrate)……40mg
PKR 20,000/-: 23.02.2018
PKR 20,000/-: 25.09.2019
Type of Form Form 5
Approval status of product in Reference PROTONIX (pantoprazole sodium) delayed-release tablets
Regulatory Authorities. 40mg, for oral use. USFDA approved
Me-too status PROTIUM GASTRO RESISTANT TABLETS 40mg. Reg.
No. 21039
recommended the grant of DML.
Remarks of the Evaluator(IX).  The brand, generic or strength has not been mentioned on
the fee challan. The firm submitted undertaking
 The firm revised the dosage form from capsule to delayed
release tablet with submission of Rs. 20000/- fee.
 Correction of pantoprazole to pantoprazole sodium
sesquihydrate in Master formula along with adjustment of
its weight as per salt factor.
 The reference product has a sub-coating above which
enteric coating is present. The submitted dossier does not
depict the same.
Previous decision The Board in its 293rd meeting deferred the case for for
clarification of composition of applied product regarding the
sub-coating above which the enteric coating is present as per
the composition of the reference product.
Evaluation by PEC The firm revised pantoprazole to pantoprazole sodium
sesquihydrate in Master formula along with adjustment of its
weight as per salt factor and revised the manufacturing
outlines.

submission of fee for revision of master formula.
Evaluation by PEC  The firm has already submitted fee of Rs. 20000/- of
revision of dosage form. The Board may review its
decision
871. Name and address of manufacturer / Relizon Pharmaceuticals, 118, Sunder Industrial Estate,
Applicant Lahore
Brand Name +Dosage Form + Strength Pantozon Tablet 20mg
Pantoprazole (as sodium sesquihydrate)……20mg
PKR 20,000/-: 23.02.2018
PKR 20,000/-: 25.09.2019
Type of Form Form 5
Approval status of product in Reference MHRA approved
Me-too status Panzium (pantoprazole base) capsules 20mg. 60482
Remarks of the Evaluator(IX).  The brand, generic or strength has not been mentioned on
the fee challan. The firm submitted undertaking
 The firm revised the dosage form from capsule to delayed
release tablet with submission of Rs. 20000/- fee.
 Correction of pantoprazole to pantoprazole sodium
sesquihydrate in Master formula along with adjustment of
its weight as per salt factor.
 The reference product has a sub-coating above which
enteric coating is present. The submitted dossier does not
depict the same.
Previous decision The Board in its 293rd meeting deferred the case for for
clarification of composition of applied product regarding the
sub-coating above which the enteric coating is present as per
the composition of the reference product.
Evaluation by PEC The firm revised pantoprazole to pantoprazole sodium
sesquihydrate in Master formula along with adjustment of its
weight as per salt factor and revised the manufacturing
outlines.
submission of fee for revision of master formula.
Evaluation by PEC  The firm has already submitted fee of Rs. 20000/- of
revision of dosage form. The Board may review its
decision
872. Name and address of manufacturer/ M/s Alen Pharmaceuticals Pvt Ltd. 138-Nowshera Industrial,
Applicant Risalpur, KPK. by M/s Bio Labs Pvt Ltd.Plot # 145, Industrial
Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form + Strength Winlor 8mg Injection
Lornoxicam…8mg
Diary No. Date of R & I & fee Dy. No. 1153 09.01.2019
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
XEFO 8 mg powder and solvent for solution for injection.
GMP status Alen Pharma: Suspension of Production activities in all
Sections on 15.01.2020.
Biolab: The firm was inspected on 18 & 23.04.2019 with the
following conclusion:
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.
(IX)
Remarks of the Evaluator The firm submitted list of 03 products registered for contract
manufacturing.
Previous decision The Board in its 295th meeting deferred the case for for
following:
 Confirmation of manufacturing requirement of
product, facility by manufacturer and also whether
firm is manufacturing for itself or otherwise.
 DML status of M/s Alen
Evaluation by PEC  The firm submitted that lyphlization is being
performed by M/s Bio-Lab (Pvt) Ltd.
Decision: Deferred for DML status of M/s Alen Pharmaceuticals Pvt Ltd.
Applicant Risalpur, KPK. by M/s Bio Labs Pvt Ltd.Plot # 145,
Industrial Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form + Strength Winrose Injection 100mg/5ml
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
Approval status of product in Reference VENOFER iron 100mg/5mL (as iron(III) hydroxide sucrose
Regulatory Authorities. complex) injection ampoule. TGA approved
Remarks of the Evaluator(IX)  Revise the label claim and salt from in line with the
reference product along with submission of
applicable fee.
 The firm submitted list of 03 products registered for

following:
 Confirmation of manufacturing requirement of
product, facility by manufacturer and also whether
firm is manufacturing for itself or otherwise.
Evaluation by PEC  The firm did not submit copy of DML.
elemental Iron. Iron sucrose is gerneric term used for
iron(III) hydroxide sucrose complex in TGA
Australia.
Brand Name + Dosage Form + Strength Zolid 600mg/300ml Infusion
Linezolid…600mg
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
Approval status of product in Reference ZYVOX linezolid 600mg/300mL injection infusion bag.
Regulatory Authorities. TGA approved
Remarks of the Evaluator(IX)  The firm submitted list of 03 products registered for
Previous decision The Board in its 295th meeting deferred the case for DML
status of M/s Alen
Brand Name + Dosage Form + Strength Locrim 400mg Infusion
Moxifloxacin as Hcl…400mg
PKR. 50,000/-; 07.01.2019
Type of Form Form 5

Approval status of product in Reference AVELOX IV 400 moxifloxacin 400 mg/250 mL (as
Regulatory Authorities. hydrochloride) intravenous infusion solution bottle. TGA
approved
Remarks of the Evaluator(IX)  The firm submitted list of 03 products registered for
Previous decision The Board in its 295th meeting deferred the case for DML
status of M/s Alen
876. Name and address of manufacturer/ M/s Cibex Pvt Ltd. F-405, S.I.T.E, Karachi, Pakistan
Applicant
Brand Name + Dosage Form + Strength Omora Insta 40/1680 mg Sachet
Omeprazole…40mg
PKR. 20,000/-; 14.01.2019
Pharmacological Group USP
Type of Form Form 5
Approval status of product in Reference Omeprazole and sodium bicarbonate (Packet) for oral
Regulatory Authorities. suspension. approved by US-FDA
Me-too status Risek Insta Sachet by Getz Pharma (Pvt.) Ltd., Karachi Reg.
No. 58548
GMP status The firm has been issued GMP certificate on the bsis of
Remarks of the Evaluator(IX)  The firm has added 3% overage of Omeprazole with
the justification to compensate loss during
manufacturing.
Previous decision  The Board in its 295th meeting deferred the case for
scientific rationale for addition of 3% overage.
Evaluation by PEC  The firm submitted that overage is added to
compensate the potency loss during manufacturing.
Decision: Deferred for scientific rationale for addition of overage.
877. Name and address of manufacturer/ M/s Cibex Pvt Ltd. F-405, S.I.T.E, Karachi, Pakistan
Applicant
Brand Name + Dosage Form + Strength Ketafen Gel Extra
Composition Contains:
Diclofenac diethylamine…2.32% w/w
PKR. 20,000/-; 21.01.2019
Type of Form Form 5
Approval status of product in Reference VOLTAROL EXTRA STRENGTH EMULGEL 2.32%
Regulatory Authorities. GEL. MHRA approved
VOLTAREN EMULGEL JOINT PAIN EXTRA
STRENGTH (11.6% w/w, 2.32 w/w). Health Canada
approved
Me-too status Sofac Gel 2%
(DiclofenacDiethylamine23.20mgeq.toDiclofenac…20mg).
Reg. No. 60356
 The firm revised the label claim from Diclofenac
diethylamine…2% to Diclofenac
diethylamine…2.32%, and claimed submission of Rs.
5000/- fee. The fee challan and endorsement form
STO is missing. The fee for revision of strength may
also be clarified by the registration Board.
 Clarify whether the strength is w/w or w/v.
Previous decision  The Board in its 295th meeting deferred the case for
submission of fee for revision of formulation.
Evaluation by PEC  The firm submitted illegible copy of fee challan
without endorsement from STO.
Decision: Deferred for submission of fee challan as per proceedure.
878. Name and address of manufacturer / M/s Caraway Pharmaceuticals.
Applicant Plot # 12, Street N-3, National industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Strength Vomiron 4mg Tablets
Diary No. Date of R& I & fee Dy. No. 40266: 05.12.2018 Rs. 20,000: 05.12.2018
Type of Form Form 5
Pack size & Demanded Price 1x10’s, 2x10’s, 3x10’s, 5x10’s, 10x10’s; As per SRO
GMP status The firm was inspected on 26.02.2019 with GOOD GMP
compliance.
 You have mentioned coating composition in the
master formula. Revise the label claim accordingly.
 Revise “Ondansetron HCl as dihydrate” to
“Ondansetron as HCl dihydrate” in the label claim.
Correction is also required in the master formula along
with adjustment of weight of API as per salt factor.
 Justify the addition of overage.
Previous decision The Board in its 295th meeting deferred the case for:
 Revision of formulation as per the reference product
along with submission of fee for revision of
formulation
 Submission of undertaking of Form 5 signed by
production incharge and QC incharge.
 Justification of addition of overage
Evaluation by PEC  The firm had mentioned coating composition in the master
formula. The firm revised the label claim from “Each Tablet
Contains” to “Each film-coated tablet contains”. And
submitted Rs. 5000/- fee.

 The firm revised “Ondansetron HCl as dihydrate” to
“Ondansetron as HCl dihydrate” in the label claim.
Correction is also required in the master formula along with
adjustment of weight of API as per salt factor.
 The firm submitted that there is no overage.
Decision: Deferred for revision of Ondansetron HCl as dihydrate to Ondansetron HCl dihydrate in
master formula only along with adjustment of weight of API as per salt factor.
Islamabad
Brand Name +Dosage Form + Strength Caraceclo 100mg Tablets
Aceclofenac…100mg
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications.
Pack size & Demanded Price 10’s, 20’s, 30’s, 50’s, 100’s; As per SRO
Approval status of product in Reference Aceclofenac 100 mg film-coated Tablets (aceclofenac).
Me-too status Acenac 100Mg Tablets. Reg. No. 39336
compliance.
Remarks of the Evaluator(IX)  The firm revised the salt form to aceclofenac from
aceclofenac sodium without submission of applicable fee.
 The firm has applied for film-coated tablet. The firm revised
the label claim and mentioned the coating composition in
master formula.
Previous decision The Board in its 295th meeting deferred the case for revision
of formulation as per the reference product along with
submission of fee for revision of formulation.
Evaluation by PEC  The firm had already revised the documents and now
Islamabad
Brand Name +Dosage Form + Strength Schizonil 200mg Tablets
Quetiapine as fumarate…200mg
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications.
Approval status of product in Reference Quetiapine (as fumarate) 200mg Film-coated Tablets. MHRA
Me-too status Etal 200mg Tablet Tablet. Reg. No. 80380
compliance.
Remarks of the Evaluator(IX)  The firm revised “quetiapine” to “quetiapine as fumarate”
without submission of fee.
 The firm had applied for film-coated tablet. The firm revised
the label claim and mentioned the coating composition in
master formula.
 Brand name and dosage form has not been mentioned in the
fee challan.
th
following:
along with submission of fee for revision of
formulation.
 Clarification why the brand name and dosage form is
not mentioned on fee challan.
Evaluation by PEC  The firm had already revised the documents and now
Islamabad
Brand Name +Dosage Form + Strength Ometro 40mg Capsule
Omeprazole…40mg
Type of Form Form 5
Pack size & Demanded Price 14’s, 2x10’s, 3x10’s, 5x10’s, 10x10’s; As per SRO
Approval status of product in Reference Losec 40 mg hard gastro-resistant capsules. Approved by
Regulatory Authorities MHRA
Me-too status Omecap Capsule. Reg. No. 84494
compliance.
Remarks of the Evaluator(IX)  The label claim is “Each hard gelatin capsule
contains:
Omeprazole…40mg”. The reference product is hard
gastro-resistant capsules. The firm was asked to
submit source, GMP of source and COA and stability
data of three batches of pellets conducted in zone IV-
A. The firm did not submit the same. The Boards is
requested to clarify the matter of label claim is as
well and submission of fee for change thereof.
Previous decision The Board in its 295th meeting deferred the case for following:
 Source of pellets, along with stability studies data,
GMP certificate of pellets manufacturer and
differential fee in case of import of pellets.
 Revision of label claim as per the reference product.
Evaluation by PEC  The firm submitted the source of pellets (M/s Vision
Pahrmaceuticals, Islamabad) and submitted Rs. 5000/- fee.
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Beta-C Cream
Betamethasone as dipropionate…0.05%
Clotrimazole…1%
Pharmacological Group Antifungal with corticosteroids
Type of Form Form-5
Pack size & Demanded Price 5g, 10g, 15g, 30g; As per SRO
Approval status of product in Reference LOTRISONE® (clotrimazole and betamethasone dipropionate)
Regulatory Authorities cream, for topical use (1%/0.05%). USFDA Approved
Me-too status Holfungin Cream. Reg. No. 67598
compliance.
Remarks of the Evaluator(IX) Undertaking at the end of Form 5 has not been signed by the
production manager and QCM by the QCM and production
manager.
Brand name and dosage form has not been mentioned in the
fee challan.
Evaluation by PEC  The firm submitted undertaking of Form 5.
 The firm submitted that by mistake they have not mentioned
dosage form and brand name on the fee challan.
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Burn-Off Cream
Silver sulphadiazine…1%w/w
Pharmacological Group Sulfonamides
Type of Form Form 5
Approval status of product in Reference Flamazine Cream 1.0%w/w. MHRA approved
Me-too status SILZIN CREAM Reg. No. 21193
compliance.
Remarks of the Evaluator(IX) Undertaking at the end of Form 5 has not been signed by the
production manager and QCM.
Brand name and dosage form has not been mentioned in the
fee challan.
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Rash-Care Cream
Zinc oxide…8.5% w/w
Benzalkonium chloride…0.1% w/w
Type of Form Form 5
Me-too status RASHNIL CRM (8.5%/1%). Reg. No. 6356
compliance.
Remarks of the Evaluator(IX)  Provide evidence of approval of applied formulation
in reference regulatory authorities/agencies which
were adopted by the Registration Board in its 275th
meeting.
 Brand name and dosage form has not been mentioned
in the fee challan.
 Evidence of approval of applied formulation in
adopted by the Registration Board in its 275th
meeting.
regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting is required.
authorities/agencies which were adopted by the Registration Board in its 275 th meeting and
pharmacological group.
Islamabad
Brand Name +Dosage Form + Strength Olimag-F Capsule
Fluoxetine as Hydrochloride…25mg
Olanzapine…12mg
Pharmacological Group Antipsychotics and selective serotonin reuptake inhibitors
Type of Form Form 5
Approval status of product in Reference SYMBYAX (olanzapine and fluoxetine) capsules by Eli Lilly
Regulatory Authorities and Company. Approved by US-FDA
Me-too status Olanco Capsules. Reg. No. 79387
compliance.
 Undertaking at the end of Form 5 has not been signed
by the production manager and QCM.
in the fee challan.
th
Decision:Approved.
Islamabad
Brand Name +Dosage Form + Strength Ompro-S Capsule
Omeprazole…20mg
Pharmacological Group Proton pump inhibitors + antacid
Type of Form Form 5
Approval status of product in Reference ZEGERID® (omeprazole and sodium bicarbonate) capsules
Regulatory Authorities (20/1100mg and 40/1100mg) capsule. USFDA approved
Me-too status Zogital 20mg Capsules (omeprazole base). Reg. No. 64391
compliance.
Remarks of the Evaluator(IX)  Undertaking at the end of Form 5 has not been signed
in the fee challan.
Islamabad
Brand Name +Dosage Form + Strength Ompro-S Plus Capsule
Omeprazole…40mg
Pharmacological Group Proton pump inhibitors + antacid
Type of Form Form 5
Approval status of product in Reference ZEGERID® (omeprazole and sodium bicarbonate) capsules
Regulatory Authorities (20/1100mg and 40/1100mg) capsule. USFDA approved
Me-too status Omfast 40/1100mg Capsule. Reg. No. 82717
compliance.
Remarks of the Evaluator(IX)  Brand name and dosage form has not been mentioned
in the fee challan.
by the production manager and QCM by the
porudction manager and QCM.

Islamabad
Brand Name +Dosage Form + Strength Lorncam 8mg Tablets
Lornoxicam…8mg
(oxicams)
Type of Form Form 5
compliance.
 Dosage form has not been mentioned in the fee
challan.
Decision: Approved.
889. Name and address of manufacturer/ M/s Bio Labs Pvt Ltd.
Applicant Plot # 145, Industrial Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form + Strength Feloxacine Tablets 400mg
Lomefloxacin as Hcl…400mg
PKR. 20,000/-; 19.02.2019
Type of Form Form-5
Approval status of product in Reference Maxaquin® lomefloxacin (as hydrochloride) film-coated
Regulatory Authorities. tablets 400mg. TGA approved
Me-too status Lomedin Tablets 400mg. Reg No. 28668 (does not depict
film-coating)
GMP status As above
Remarks of the Evaluator(IX)  Revise Lomefloxacin Hcl to Lomefloxacin as Hcl in

the label claim


You have claimed USP specifications. Provide proof
that the finished product is available in USP.
Previous decision  The Board in tis 295th meeting deferred the case for
revision of formulation as per reference product along
with submission of requisite fee.
Evaluation by PEC  The firm revised the formulation as per reference
product al0ong with submission of Rs. 5000/-.
 The firm claimed BP specifications. The product is
not available in BP.
Brand Name + Dosage Form + Strength Fixetin Tablet 10mg
Fluoxetine as HCL…10mg
PKR. 20,000/-; 25.02.2019
Type of Form Form-5
Approval status of product in Reference SARAFEM (fluoxetine as hydrochloride 10mg, 15mg, 20mg
Regulatory Authorities. uncoated tablets). USFDA approved
Me-too status Futine 10 mg Tab. Reg. No. 44602 (Fluoxetine
HCL…10mg)
GMP status As above
Remarks of the Evaluator(IX)  Provide proof of reference product (film-coated

tablet) in reference regulatory agencies as defined in
275th meeting of the registration Board. Otherwise,
revise the formulation (label claim, composition and
manufacturing outlines) to uncoated tablet, along
with submission of applicable fee.
and registration number) approved by DRAP.
Previous decision  The Board in tis 295th meeting deferred the case
Evaluation by PEC  The firm did not revise the formulation as per
reference product, but submitted Rs. 5000/- fee.
Brand Name + Dosage Form + Strength Desfaxine 100mg Tablets
Composition Each extended release tablet contains
Desvenlafaxine as succinate monohydrate …100mg
PKR. 20,000/-; 25.02.2019
Type of Form Form-5
Approval status of product in Reference Pristiq extended release tablets 100mg (film-coated).
Me-too status Denla XR 100mg Tablet. Reg. No. 70434 (Does not depict
coating)
GMP status As above
th
Remarks of the Evaluator(IX)  Revise Desvenlafaxine succinate to Desvenlafaxine
as succinate monohydrate in the label claim
Evaluation by PEC  The firm revised Desvenlafaxine succinate to
Desvenlafaxine as succinate monohydrate in the label
claim.
Decision: Approved.
Brand Name + Dosage Form + Strength Desfaxine 50mg Tablets
Composition Each extended release tablet contains
Desvenlafaxine as succinate monohydrate …50mg
PKR. 20,000/-; 25.02.2019
Type of Form Form-5
Approval status of product in Reference Pristiq extended release tablets 50mg (film-coated). USFDA
Me-too status Denla XR 50mg Tablet. Reg. No. 70433 (Does not depict
coating)
GMP status As above
Remarks of the Evaluator(IX)  Revise Desvenlafaxine succinate to Desvenlafaxine

as succinate monohydrate in the label claim
Evaluation by PEC  The firm revised Desvenlafaxine succinate to
Desvenlafaxine as succinate monohydrate in the label
claim.
Decision: Approved.
893. Name and address of manufacturer / M/s. SAFE Pharmaceuticals Pvt. Ltd
Applicant Plot No. C.I-20, Sector 6-B, North Karachi Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Liptramide Tablet 5/10mg
Composition Each Film coated tablet contains
Amlodipine as besylate……5mg
Atorvastatin as calcium trihydrate……..…10mg
Diary No. Date of R& I & fee Dy. No. 40763 : 06.12.2018, Rs. 20,000: 06.12.2018
Type of Form Form-5
Pack size & Demanded Price 1x 10’s & 1 x 14’s As per SRO
Approval status of product in Reference CADUET® (amlodipine besylate and atorvastatin calcium)
Regulatory Authorities tablets, film-coated (5mg/10mg, 5mg/20mg, 5mg/40mg,
5mg/80mg; 10mg/10mg, 10mg/20mg, 10mg/40mg,
10mg/80mg; 2.5mg/10mg, 2.5mg/20mg, 2.5mg/40mg).
USFDA Approved
Me-too status Zodip Plus 10 Tablet. Reg. No. 59794
GMP status GMP Inspection of the firm was conducted on 04-03-2019
with the following conclusion:

All the observations pointed out during inspection were
discussed with the management of the firm and they were
committed to overcome before next periodic inspection. Based
on the above observations and keeping in view their attitude
for better compliance, their current compliance level is rated as
Good.
 Blistering and packing process is missing in the
 The firm has mentioned atorvastatin (base) in Form 5.
However, the correct salt form has been mentioned in
composition and master formula.
Previous decision The Board in tis 295th meeting deferred for following:
Submission of complete outline of method of
manufacturing
Revision of formulation as per the reference product along
Evaluation by PEC  The firm revised Atorvastatin to Atorvastatin as
calcium Trihydrate in Form 5.
 The firm submitted revised manufacturing outlines.
Decision: Deferred for submission of fee for revision of salt form.
Karachi
Amlodipine as besylate.……..5mg
Atorvastatin as calcium trihydrate……..…20mg
Type of Form Form-5
Pack size & Demanded Price 1x 10’s & 1 x 14’s; As per SRO
USFDA Approved
Me-too status Zodip Plus 20 Tablet. Reg. No. 59795
GMP status As above
Remarks of the Evaluator(IX)  Blistering and packing process is missing in the
manufacturing
Karachi
Amlodipine as besylate………5mg
Atorvastatin as calcium trihydrate………40mg
Type of Form Form-5
USFDA Approved
Me-too status Co-Atorap 5/40 Tablet. Reg. No. 55142 (does not depict film-
coating)
GMP status As above
manufacturing
along with submission of requisite fee.
Karachi
Diary No. Date of R& I & fee Dy. No. 40766 : 06.12.2018, Rs.20`,000: 06.12.2018
Type of Form Form-5
USFDA Approved
Me-too status Corsafe AT 10/10 Tablets. Reg. No. 68320
GMP status As above
manufacturing
Karachi
Type of Form Form-5
USFDA Approved
Me-too status Corsafe AT 10/20 Tablets. Reg. No. 68321
GMP status As above
manufacturing
Karachi
Type of Form Form-5
USFDA Approved

Me-too status Co-Atorap 10/40 Tablet. Reg. No. 50589 (does not reveal film-
coating)
GMP status As above
manufacturing
Karachi
Brand Name +Dosage Form + Strength Fludecan Injection 25mg/ml
Composition Each ml contains
Fluphenazine decanoate …………….…25mg
Diary No. Date of R& I & fee Dy. No. 40766 : 06.12.2018, Rs. 20,000: 06.12.2018 Daed
06.12.2018
Pharmacological Group Phenothiazines with piperazine structure
Type of Form Form-5
Pack size & Demanded Price 1ml x 1’s Ampoule As per SRO
Approval status of product in Reference Modecate Injection 25mg/ml (0.5ml, 1ml, 2ml) for IM use.
Me-too status Fenzitec Depot Injection. Reg. No. 73773
GMP status As above
Remarks of the Evaluator(IX)  Terminal sterilization process is missing in the
Previous decision The Board in tis 295th meeting deferred for submission of
detailed method of sterilization.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Dibilo M 1/500 Tablet
Composition Each film-coated tablet contains
Glimepride ………….….……..1mg
Metformin HCl……..……..500mg
Pharmacological Group Sulfonylureas + Biguanides
Type of Form Form 5
Pack size & Demanded Price 3 x 10’s As per SRO
Me-too status Diabold Plus Tablet (film-coated). Reg. No. 76011
GPRIDE-M SR 1/500mg tablet (bilayer). Reg. No. 76306
GMP status As above

Remarks of the Evaluator(IX)  The firm revised the composition and manufacturing
outlines to film-coated tablet. Revision of label claim and
submission of applicable is required.
Previous decision The Board in its 295th meeting 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  The firm submitted revised manufacturing outlines.
meeting.
 Fee for revision of formulation shall be discussed.
Karachi
Brand Name +Dosage Form + Strength Dibilo M 2/500 Tablet
Glimepride …………………..2mg
Metformin HCl…………..500mg
Pharmacological Group Biguanide / Sulphonylurea
Type of Form Form-5
GMP status As above
outlines to film-coated tablet. Revision of label claim
and submission of applicable is required.
Previous decision The Board in its 295th meeting deferred for evidence of
approval of applied formulation in reference regulatory
meeting.
 Fee for revision of formulation shall be discussed.
Karachi
Brand Name +Dosage Form + Strength Sodium Chloride 0.9% w/v 10ml Ampoules
Sodium Chloride…………..…90mg
Pharmacological Group Electrolyte
Type of Form Form-5
Pack size & Demanded Price 10mlx1’s As per SRO
Approval status of product in Reference Sodium Chloride Injection BP 0.9% w/v in type I clear glass
Regulatory Authorities ampoules (2ml, 5ml, 10ml and 20ml). MHRA approved
Me-too status Soride of M/s Bosch Pharma
GMP status As above
Remarks of the Evaluator(IX)  Terminal sterilization is missing in the manufacturing
outlines.
 The firm has claimed USP specifications. Available in
BP.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Sodium Chloride 0.9% w/v 2.5ml Ampoules
Composition Each 2.5ml contains
Sodium Chloride……………22.5mg
Pharmacological Group Electrolyte
Type of Form Form-5
Me-too status Sodium Chloride 0.9% Injection (10ml). Reg. No. 84871
GMP status As above
Remarks of the Evaluator(IX) Provide evidence of approval of applied formulation (same
filled volume) in reference regulatory authorities/agencies
which were adopted by the Registration Board in its 275th
meeting.
 Terminal sterilization is missing in the
 The firm has claimed USP specifications. Available
in BP.
Decision: Evidence of approval of applied formulation in reference regulatory authorities which
were adopted by Registration Board in its 275th meeting.
Karachi
Brand Name +Dosage Form + Strength Sericalm Injection 50mg/ml
Haloperidol as decanoate………..…50mg
Pharmacological Group Butyrophenone derivatives
Type of Form Form-5
Pack size & Demanded Price 1’s Ampoule As per SRO

Approval status of product in Reference HALDOL® 50, 100 (haloperidol as decanoate) For IM
Regulatory Authorities Injection Only (1ml ampule). USFDA Approved with box
warning
Me-too status Seredol Depot Injection (1ml). Reg. No. 60600
GMP status As above
Remarks of the Evaluator(IX)  Revise “Haloperidol decanoate” to “Haloperidol as
decanoate” in the label claim
 Terminal sterilization is missing in the manufacturing
outlines.
Previous decision The Board in tis 295th meeting deferred the case for following:
Revision of formulation as per reference product along with
submission of requisite fee.
Submission of detailed method of sterilization.
The firm revised “Haloperidol decanoate” to “Haloperidol as
decanoate” in the label claim.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Lorsafe Tablet 4mg
Lornoxicam…………………4mg
Type of Form Form 5
Approval status of product in Reference Xefo 4 mg Filmtabletten (Swiss Medic approved)
Me-too status Noxilor Tablet. Reg. No. 84039
GMP status As above
Remarks of the Evaluator(IX) Blistering and packing process is missing in the
Previous decision The Board in tis 295th meeting deferred the case for
submission of complete outline of method of manufacturing.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Lorsafe Tablet 8mg
Lornoxicam……………….…8mg
Type of Form Form 5
GMP status As above
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength S Vant Tablet 8mg
Composition Each Tablet contains
Candesartan Cilexetil………..…8mg
Pharmacological Group Angiotensin II antagonists, plain
Type of Form Form 5
Approval status of product in Reference ATACAND® (candesartan cilexetil) 8 mg non-film-coated
Regulatory Authorities tablets, for oral use by ANI Pharms Inc. US-FDA approved
Me-too status Cansart 8mg Tablets by CCL Pharma. Reg. No. 82665
GMP status As above
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength S Vant Tablet 16mg
Candesartn Cilexetil………….…16mg
Pharmacological Group Angiotensin II antagonists, plain
Type of Form Form 5
Approval status of product in Reference ATACAND® (candesartan cilexetil) 16 mg non-film-coated
Regulatory Authorities tablets, for oral use. US-FDA approved
Me-too status Cansart Tablets by CCL Pharma. Reg. No. 33953
GMP status As above
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Beca Tablet 60mg
Composition Each film-coated Tablet contains:
Etoricoxib………………60mg
Diary No. Date of R& I & fee Dy. No. 41955: 07.12.2018 Rs. 20,000
Pharmacological Group Coxibs
Type of Form Form-5
Finished product Specification In-house

Approval status of product in Reference Etoricoxib 60 mg Film-coated Tablets. MHRA approved
Me-too status Eto 60 mg Tablet. Reg. No. 78176
GMP status As above
is required along with submission of applicable fee.
 Provide finished product specifications.
Previous decision The Board in tis 295th meeting deferred the case for for
following:
Submission of finished product specification.
manufacturing.
The firm revised the label claim to film-coated tablet without
submission of fee.
The firm claimed in-house specifications.
Karachi
Brand Name +Dosage Form + Strength Samide Tablet 50mg
Composition Each filmcoated tablet contains
Lacosamide……………50mg
Diary No. Date of R& I & fee Dy. No. 41956: 07.12.2018 Rs. 20,000
Type of Form Form-5
Finished product Specification Manufacturer’s specifications
Approval status of product in Reference Lacosamide Aspire 50 mg film-coated tablets by Aspire
Regulatory Authorities Pharma Limited. MHRA Approved
Me-too status Lalap 50mg tablet. Reg. No. 70470
GMP status As above
following:
manufacturing.
submission of fee.
Karachi
Brand Name +Dosage Form + Strength Samide Tablet 100mg
Composition Each film-caoted tablet contains
Lacosamide………………100mg
Pharmacological Group Sodium Channel Inactivator
Type of Form Form-5
Approval status of product in ReferenceVIMPAT® (lacosamide) film coated tablet, for oral use (50mg,
Regulatory Authorities 100mg, 150mg, 200mg). USFDA approved
Me-too status Lacomide 100mg Tablet film-coated. Reg. No. 83976
GMP status As above
following:
manufacturing.
submission of fee.
Karachi
Brand Name +Dosage Form + Strength Kulb Plus Tablet 50mg/12.5mg
Losartan Potassium ……….……50mg
Hydrochlorothiazide……….…12.5mg
Diary No. Date of R& I & fee Dy. No. 41959: 07.12.2018 Rs.20,000: 07.12.2018
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics
Type of Form Form 5
Approval status of product in Reference FORTZAAR 50 mg / 12.5 mg film-coated tablets. ANSM
Me-too status Rosar-H Tablets. Reg. No. 64218
GMP status As above
 The firm revised the composition and manufacturing
following:
manufacturing.
submission of fee.

Karachi
Brand Name +Dosage Form + Strength R-Tatin Tablet 5mg
Rosuvastatin (as calcium)…………5mg
Pharmacological Group HMG-CoA reductase inhibitor
Type of Form Form-5
Approval status of product in Reference Crestor 5mg film-coated tablets. MHRA approved
Me-too status Rostat 5mg Tablet. Reg. No. 55729
GMP status As above
 The firm has mentioned rosuvastatin (base) in Form 5.
following:
manufacturing.
The firm revised Rosuvastatin to Rosuvastatin (as calcium) in
the label claim without submission of fee.
Karachi
Rosuvastatin (as calcium)…………10mg
Type of Form Form-5
Me-too status Rosan 10mg Tablet. Reg. No. 81462
GMP status As above
 The firm has mentioned rosuvastatin (base) in Form 5.
following:
manufacturing.
the label claim to without submission of fee.
Karachi
Rosuvastatin (as calcium)……….…20mg
Type of Form Form-5
Me-too status Rostat 20mg Tablet. Reg. No. 55731
GMP status As above
Remarks of the Evaluator(IX) Adjust the weight of APIs as per salt factor in master formula
only.
Provide finished product specifications.
Blistering and packing process is missing in the manufacturing
outlines.
The firm has mentioned rosuvastatin (base) in Form 5.
following:
manufacturing.
Submission of finished product specification
Submission of master formulation in line with the reference
product
 The firm revised Rosuvastatin to Rosuvastatin (as
calcium) in the label claim to without submission of
fee.
 Submission of finished product specification is
required
 Submission of master formulation in line with the
reference product is required
 Fee for revision of salt form.
 Submission of finished product specification is required.
 Submission of master formulation in line with the reference product.
Karachi
Rosuvastatin (as calcium)………..…40mg
Type of Form Form-5
Me-too status Rosugen Tablet 40mg. Reg. No. 84109
GMP status As above
 The firm has mentioned rosuvastatin (base) in Form
5. However, the correct salt form has been
mentioned in composition and master formula.
following:
manufacturing.
the label claim to without submission of fee.
Decision: Deferred for fee for revision of salt form.
Karachi
Brand Name +Dosage Form + Strength Thicoside Capsule 4mg
Composition Each capsule contains
Thiocolchicoside…………..…4mg
Diary No. Date of R& I & fee Dy. No 41964: 07.12.2018 Rs. 20,000: 07.12.2018
Type of Form Form-5
Approval status of product in Reference MIOREL 4 mg capsule. ANSM approved
Me-too status Muscucoside capsule 4mg. Reg. No. 81656
GMP status As above
Karachi
Brand Name +Dosage Form + Strength Iron Fort Syrup
Ferric Ammonium citrate …1000mg
Folic Acid……………………..11mg
Pyridoxine HCl.....…………...48mg
Thiamine HCl……….…..…...24mg
Nicotinamide………..………220mg
Pharmacological Group Iron with multi-Vitamins
Type of Form Form-5
Pack size & Demanded Price 200ml Bottle 1’s As per SRO

GMP status As above
Remarks of the Evaluator(IX)  Provide evidence of approval of applied formulation in
registration number and name of company) with same
composition same strength and same salt form(s) by
DRAP.
 Packing process is missing in the manufacturing outlines.
following:
Evidence of approval of applied formulation in
meeting.
Evidence of applied formulation/drug already
alongwith registration number, brand name and name
of firm.
manufacturing.
meeting not provided.
alongwith registration number, brand name and name
of firm not provided.
 Evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting
along with registration number, brand name and name of firm
Karachi
Brand Name +Dosage Form + Strength Cerin Capsule 50mg
Composition Each Capsule contains
Diacerein………...…50mg
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-steroids
Type of Form Form-5
Approval status of product in Reference ART 50 mg capsule. ANSM approved
Me-too status Diora 50mg Capsule. Reg. No. 67631
GMP status As above
Karachi
Brand Name +Dosage Form + Strength Ocedophine Tablet 400/60mg
Ibuprofen………..……...400mg
Pseudoephedrine HCl…………60mg
Pharmacological Group Propionic Acid and sympathomimetics
Type of Form Form-5
Approval status of product in Reference Lasynac Max Strength 400mg/60mg film coated tablets.
Me-too status Irofen Forte Tablets. Reg. No. 42233
GMP status As above
Remarks of the Evaluator(IX)  The firm revised “Pseudoephedrine” to
“Pseudoephedrine HCl” in composition. Revision of
label claim is required along with submission of
applicable fee.
 Revision of formulation to film-coated tablet is required.
manufacturing.
 The firm revised the tablet to film-coated tablet.
 The firm revised “Pseudoephedrine” to
“Pseudoephedrine HCl” in the label claim without
submission of fee.
 Revision of “Pseudoephedrine” to “Pseudoephedrine
HCl” in master formula is still required.
 Fee for revision of salt form and formulation.
 Revision of “Pseudoephedrine” to “Pseudoephedrine HCl” in master formula
Karachi
Brand Name +Dosage Form + Strength Gaba Capsule 100mg
Gabapentin……….…100mg
Type of Form Form-5
Approval status of product in Reference Gabapentin 100mg Capsules. MHRA approved
Me-too status Pentowan 100mg Capsule. Reg. No. 79688
GMP status As above
(IX)
Remarks of the Evaluator Blistering and packing process is missing in the manufacturing
outlines.
th
Decision: Approved.
Karachi
Gabapentin………...…300mg
Type of Form Form-5
Me-too status Pentowan 300mg Capsule. Reg. No. 82103
GMP status As above
Remarks of the Evaluator(IX) Blistering and packing process is missing in the manufacturing
outlines.
Decision: Approved.
Karachi
Gabapentin…………..…400mg
Type of Form Form-5
Me-too status NEURONTIN CAPSULES 400mg. Reg. No. 16141
GMP status As above
Remarks of the Evaluator(IX) Blistering and packing process is missing in the manufacturing
outlines.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Dexi Tablet 200mg
Dexibuprofen ……………200mg
Pharmacological Group Propionic acid derivatives
Type of Form Form-5
Finished product Specification Manufacturer’s specification
Approval status of product in Reference Dexibuprofen 200 mg film-coated tablets MHRA Approved
Me-too status Haltrin 200mg Tablet. Reg. No. 61068
GMP status As above
manufacturing.
submission of fee.
Karachi
Dexibuprofen …………300mg
Type of Form Form-5
Me-too status Tercica 300mg Tablet. Reg. No. 58445
GMP status As above
 The firm revised the composition and manufacturing
manufacturing.
submission of fee.
Karachi
Dexibuprofen …………..…400mg
Type of Form Form-5
Me-too status Tercica 400mg Tablet. Reg. No. 58446
GMP status As above
manufacturing.
submission of fee.
Karachi
Brand Name +Dosage Form + Strength Dexi Syrup 100mg.5ml
Dexibuprofen ……….…100mg
Type of Form Form-5
Pack size & Demanded Price 120ml & 60ml; As per SRO
Me-too status Tercica 100mg/5ml. Reg. No. 61206
GMP status As above
Remarks of the Evaluator(IX)  Packing process is missing in the manufacturing outlines.
meeting.
registration number and name of company) with same
formulation and same strength by DRAP.
regulatory authorities / agencies which were adopted by the
Registration Board in its 275th meeting.
manufacturing.
regulatory authorities / agencies which were adopted by
the Registration Board in its 275th meeting not provided.
Karachi
Brand Name +Dosage Form + Strength Ceral Tablet 6.4mg
Glyceryl Trinitrate………….…6.4mg
Pharmacological Group Organic nitrates
Type of Form Form-5
Approval status of product in Reference Sustac 6.4mg prolonged release tablet. MHRA Approved
Me-too status Slotac S.Rtablet 6.4mg. Reg. No. 25168
GMP status As above
Remarks of the Evaluator(IX)  The firm revised the composition to prolonged release
tablet. Revision of label claim is required along with
 The firm revised glycerol to Glyceryl throughout the
dossier.
manufacturing.
 Revision of label claim to prolonged release tablet is
required along with submission of applicable fee.
Decision: Deferred for revision of label claim to prolonged release tablet along with submission of
applicable fee.
Karachi
Brand Name +Dosage Form + Strength Ceral Tablet 2.6mg
Glycerol Trinitrate…………….…2.6mg
Pharmacological Group Organic nitrates
Type of Form Form-5
Approval status of product in Reference Sustac 2.6mg prolonged release tablet. MHRA Approved
Me-too status Slotac S.Rtablet 6.4mg. Reg. No. 25167
GMP status As above
Remarks of the Evaluator(IX)  The firm revised the composition to prolonged release
tablet. Revision of label claim is required along with
 The firm revised glycerol to Glyceryl throughout the
dossier.
manufacturing.
 Revision of label claim to prlonged release tablet is
required along with submission of applicable fee.
Decision: Deferred for revision of label claim to prolonged release tablet along with submission of
applicable fee.
Karachi
Brand Name +Dosage Form + Strength Soritic Tablet 20/12.5mg
Lisinopril as dihydrate…………...…20mg
Hydrochlorothiazide……...12.5mg
Type of Form Form-5
Approval status of product in Reference Lisoretic 20 mg/12.5 mg Tablets, uncoated, MHRA approved
Me-too status Acinopril Plus Tablets. Reg. No. 76830
GMP status As above
Remarks of the Evaluator(IX)  Revise “Lisinopril dihydrate” to “Lisinopril as dihydrate”
in the label claim.
manufacturing.
 The firm revised “Lisinopril dihydrate” to “Lisinopril as
dihydrate” in the label claim.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Sodium Bicarbonate 5% w/v Injection (0.5ml)
Sodium Bicarbonate……….…50mg
Pharmacological Group Electrolyte solutions
Type of Form Form-5
Pack size & Demanded Price 0.5ml Ampoule As per SRO
Me-too status Sodium Bicarbonate Injection. Reg. No. 76428 (does not
specify the pack volume)
GMP status As above
 Provide evidence of approval of applied formulation
(same filled volume) in reference regulatory
authorities/agencies which were adopted by the

 Terminal sterilization is missing in the manufacturing
outlines.
Submission of detailed method of sterilization.
authorities / agencies which were adopted by the Registration Board in its 275th meeting
Karachi
Brand Name +Dosage Form + Strength Sodium Bicarbonate 5% w/v Injection (1ml)
Sodium bicarbonate…………50mg
Pharmacological Group Electrolyte solutions
Type of Form Form-5
Pack size & Demanded Price 1ml Ampoule As per SRO
Approval status of product in Reference The product is present in 1ml pack size (50mg/ml) in combo
Regulatory Authorities pack of Artesunate injection. W.H.O. prequalified.
Me-too status Sodium Bicarbonate Injection. Reg. No. 76428 (does not
specify the pack volume)
GMP status As above
(IX)
Remarks of the Evaluator Terminal sterilization is missing in the manufacturing outlines.
submission of detailed method of sterilization.
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Ezicoro 10/10 mg Tablet
Ezetimibe………….….10mg
Simvastatin……….…10mg
Diary No. Date of R& I & fee Form -5 Dy.No 41981: 07.12.2018 Rs. 20,000: 07.12.2018
Pharmacological Group HMG CoA reductase inhibitors in combination with other lipid
modifying agents
Type of Form Form-5
Approval status of product in Reference VYTORIN® (ezetimibe and simvastatin) tablets, uncoated-
Regulatory Authorities tablet (10mg/210mg, 10/20mg, 10/40mg, 10/80mg). TGA
Approved
Me-too status NeoCom –S Tablets. Reg. No. 42397
GMP status As above
Remarks of the Evaluator(IX)  The firm has mentioned coating composition and process
in the revised manufacturing outlines.
manufacturing.
 The firm has mentioned coating composition and process
in the revised manufacturing outlines. The
international reference product is uncoated tablet.
Decision: Deferred for revision of master formula and manufacturing outlines.
Karachi
Ezitimbe ……………….10mg
Simvastatin……………20mg
modifying agents
Type of Form Form-5
Approved
Me-too status NeoCom –SD Tablets. Reg. No. 42398
GMP status As above
manufacturing.
Karachi
Ezitimbe …………..…….10mg
Simvastatin…………..…40mg
modifying agents
Type of Form Form-5
Approved
Me-too status NeoCom –ST Tablets. Reg. No. 42399
GMP status As above
manufacturing.
Karachi
Ezitimbe ……………..….10mg
Simvastatin…………..…80mg
modifying agents
Type of Form Form-5
Approved
Me-too status Neutrachol Plus Tablets. Reg. No. 59304
GMP status As above
manufacturing.
937. Deleted due to duplication
938. Name and address of manufacturer / Horizon Health care Private Limited
Applicant Plot No 33, Sunder industrial Estate, Lahore Pakistan
Brand Name +Dosage Form + Strength ROXAB 2.5mg Tablet
Rivaroxaban……………..2.5mg
Diary No. Date of R& I & fee Dy. No. 40703: 06.12.2018
Rs. 20,000/- : 06.12.2018

Type of Form Form-5
Finished product Specification Innovator’s Specification
Pack size & Demanded Price 10's, & 30’s; as per SRO
Approval status of product in Reference Xarelto Film Coated Tablet (2.5mg, 10mg, 15mg, 20mg). EMA
Me-too status XARELTO 2.5MG TABLETS. Reg. no. 74794
GMP status As above
Remarks of the Evaluator(IX)  Form 5 has been signed by the manager regulatory
affairs.
 The firm has changed the address in Form 5 from
Horizon Health care Private Limited Plot No 35, Small
industrial Estate, Taxila Pakistan to Horizon Health
care Private Limited Plot No 33, Sunder industrial
Estate, Lahore Pakistan without submission of any fee.
Previous decision The Board in tis 294th meeting deferred the case for clarification
since the initial application was submitted by Horizon Health
care Private Limited Plot No 35, Small industrial Estate, Taxila
which is a separate licensed manufacturer.
Evaluation by PEC This was a typographical mistake at the end of PEC. The cover
letter endorsed by R&I and PEC are from the Horizon Health care
Private Limited Plot No 33, Sunder industrial Estate, Lahore
Pakistan. Form 5 bears the name of the same manufacturer.
Moreover, the fee challan bear the DML No. 000782. The Board
may examine the original file/dossier if it deems necessary.
Decision: Approved.
939. Name and address of manufacturer Invictus Pharmaceuticals, Plot No. 21, 26, Street No. NS-2,
/ Applicant national Industrial Zone (RCCI) Rawat Rawalpindi
Brand Name +Dosage Form + Iborine Capsule 200mg
Strength
Mebeverine HCl…….200mg
PKR 20,000/-: 14.01.2019
Pharmacological Group Synthetic anticholinergics, esters with tertiary amino group
Type of Form Form 5
Approval status of product in COLOFAC® MR 200mg Capsules. MHRA approved
Me-too status Mebrest-200 Capsule. Reg. No. 80547
GMP status The firm has been granted DML on the basis of inspection
13.11.2018 & 17.12.2018.
Sourcce of pellets: The firm M/s Vision Pharmaceuticals was
inspected on 11.02.2019, wherein the panel recommended the
grant of GMP certificate.
Remarks of the Evaluator(IX).  The firm was asked to provide complete finished product
specifications (list of tests, reference to analytical procedures,
and proposed acceptance criteria). However, the firm did not
submit the same.
.
Previous decision The Board in its 289th meeting deferred the case for further
deliberation.
Evaluation by PEC  The firm submitted that they use the testing method as specified
by the manufacturer of the pellets.
Previous decision  The Board in its 291st meeting deferred the case for further
deliberation
Evaluation by PEC  The firm again submitted that they use the testing method as
specified by the manufacturer of the pellets.
Previous decision  The Board in its 295th meeting deferred the case for further
deliberation
Evaluation by PEC  The firm requested for approval of the case as the case of M/s
Lahore Chemical & Pharmaceutical Works Pvt Ltd.
137-Ferozepur Road, Lahore has already been approved.
 Decision: Approved with innovator’s specifications.
940. Name and address of manufacturer M/s Aulton Pharmaceuticals. Plot No. 84/1, Block A, Phase
/ Applicant V, Industrial Estate, Hattar, Khyber Pakhtunkhwa
Brand Name +Dosage Form + Colomat 1 MIU Injection
Strength
Colistimethate Sodium (Lyophilized Powder)…1 MIU
PKR 20,000/-: 26.07.2018
Pharmacological Group Polymyxins
Type of Form Form 5
Approval status of product in Colistimethate Sodium 1 Million I.U. Powder for Solution for
Reference Regulatory Authorities. Injection (lyophilized powder in glass vial). Approved by
MHRA
Me-too status Colistat powder for Injection. Reg. No. 76160
concluded that "Overall the firm was in good working condition
with proper documentation, adequate Equipments both in
production and quality control and qualified staff for performing
the manufacturing and analysis of the manufactured products in
accordance with the cGMP guidelines. Some of the minor
shortcomings as described above were identified to the firm for
immediate rectification. Based on the premises inspected, the
qualified staff met and documentation reviewed, it is concluded
that M/s Aulton Pharma Industrial Estate Hatter operate at good
level of compliance with cGMP guidelines”.
Remarks of the Evaluator(IX). Undertaking was not signed. The firm submitted duly signed
form 5.
Prevoius decision The Board in its 291st meeting deferred the case for submission
of undertaking.
Evaluation by PEC The firm has already submitted duly signed form 5
Prevoius decision The Board in its 293rd meeting deferred the case for confirmation
of manufacturing method (powder filling or lyophilization) and
requisite facility.
Evaluation by PEC The firm submitted cover letter wherein they have attached
leaflet of some reference product, which does not clarify the
reason behind the deferment of the case.
Prevoius decision The Board in its 295th meeting deferred the case for confirmation
of manufacturing method (powder filling or lyophilization) and
requisite facility.
Evaluation by PEC The firm submitted that the method of manufacturing is powder
filling (lyophilized powder ready to fill). The firm submitted
approval letter of dry powder injection (general).
Decision: Approved.
Applicant Plot No. 84/1, Block A, Phase V, Industrial Estate, Hattar,
K.P.K

Brand Name + Dosage Form + Diltaia-alt 60mg Tablet
Strength
Diltiazem Hydrchloride…60mg
PKR. 20,000/-; 30.11.2018
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form 5
Approval status of product in DILTIAZEM HYDROCHLORIDE TABLETS 60mg uncoated
Reference Regulatory Authorities. prolonged release tablet. MHRA approved
Me-too status Myozem Tablets 60mg. Reg. No. 41982 (does not reveal
prolonged release)
GMP status The firm was last inspected on 27.06.2019, wherein GMP was
rated satisfactory.
Remarks of the Evaluator(IX)  The reference product is uncoated prolonged release
tablet. The firm has applied for film-coated tablet. The
firm revised the formulation (label claim, composition)
to uncoated (not prolonged release ) tablet along with
submission of applicable fee. Moreover, they have still
mentioned film-coated tablet as dosage form.
Prevoius decision The Board in its 295th meeting deferred the case revision of
formulation along with outline of method of manufacturing as per
the reference product.
Evaluation by PEC The firm once again submitted Rs. 5000/- fee, but did not revise
label claim and manufacturing outlines.
The firm has mentioned Diltiazem instead of Diltiazem
Hydrchloride in the master formula.
Decision: Deferred for revision of label claim and correction of master formula.
K.P.K
Brand Name + Dosage Form + Clomi Star 50mg Tablets
Strength
Clomiphene Citrate…50mg
PKR. 20,000/-; 30.11.2018
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form 5
Approval status of product in GENRX CLOMIPHENE clomifene citrate 50mg tablet, un-
Reference Regulatory Authorities. coated. TGA approved
Me-too status OVA-MIT TABLETS. Reg. No. 20404
rated satisfactory.
Remarks of the Evaluator(IX)  The reference product is uncoated tablet. The firm has
applied for film-coated tablet. Upon clarification, the
firm submitted Rs. 5000/- but did not revise the
manufacturing outlines in line with the reference
product. Moreover, they have still mentioned film-coated
tablet as dosage form.
Prevoius decision The Board in its 295th meeting deferred the case revision of
formulation along with outline of method of manufacturing as per

Evaluation by PEC The firm submitted Rs. 5000/- fee, and revised the manufacturing
outlines.
Decision: Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and personnel
which remain in direct contact or are involved in close handling of these drugs.
K.P.K
Brand Name + Dosage Form + Aultafen 145mg Tablets
Strength
Fenofibrate…145mg
PKR. 20,000/-; 30.11.2018
Pharmacological Group Fibrates
Type of Form Form 5
Approval status of product in FENOFIBRATE BIOGARAN 145 mg, comprimé uncoated.
Reference Regulatory Authorities. ANSM approved
Me-too status Fenoget 145mg Tablet. Reg. No. 58480
rated satisfactory.
Remarks of the Evaluator(IX)  The reference product is uncoated tablet. The firm
revised the formulation (label claim, composition) in line
with the reference product along with submission of
applicable fee. Moreover, they have still mentioned
film-coated tablet as dosage form.
Prevoius decision The Board in its 295th meeting deferred the case for revision of
formulation as per the reference product along with submission
of fee for revision of formulation.
Evaluation by PEC The firm submitted Rs. 5000/- fee, and revised the label the label
claim, but did not revise the manufacturing outlines.
Decision: Deferred for correction of manufacturing outlines.
944. Name and address of A. J. Mirza Pharma (Pvt.) Ltd., Plot No.44, Sector No. 27
manufacturer/Applicant Korangi Industrial Area Karachi, Pakistan.
Brand Name+ Dosage Form+ Glistat Tablet 4mg
Strength
Glimepiride……... 4mg
Dairy No. Date of R & I fee Dy No. 7214: 26.02.2018
PKR 20,000/-: 22.02.2018
Pharmacological Group Sulfonylureas
Type of Form Form 5
Pack Size & Demanded Price 2x10’s Blister pack , As per SRO
Approval status of product in Glimepiride 4 mg tablets, uncoated (MHRA Approved)
Me-too status Glimar Tablets 4mg. Reg. No. 75958
GMP status The firm provided inspection report dated 13.03.2019, wherein
the renewal of DML for the following sections has been
recommended. Tablet (G), Capsule (G), Liquid syrup (G).
(IX)
Remarks of the Evaluator The label claim was film-coated tablet, but coating composition
and process are not mentioned in the application. The firm did
not clarify the same.

coating composition of the applied product and complete method
of manufacturing with the detail of coating process.
Evaluation by PEC The firm submitted that the tablet is uncoated. It was a typo
mistake in the label claim.
Previous decision The Board in its 295th meeting deferred the case for submission
of requisite fee for revision of formulation.
Evaluation by PEC The firm submitted Rs. 5000/- fee.
Decision: Approved.
945. Name and address of A. J. Mirza Pharma (Pvt.) Ltd.,Plot No.44, Sector No. 27
Brand Name+ Dosage Form+ Glistat Tablet 3mg
Strength
Glimepiride……... 3mg
PKR 20,000/-: 22.02.2018
Pharmacological Group Sulfonylureas
Type of Form Form 5
Approval status of product in Glimepiride 3 mg tablets, uncoated (MHRA Approved)
Me-too status Evopride 3mg Tablet by M/s Pharmevo (Reg#29133)
GMP status The firm provided inspection report dated 13.03.2019, wherein
the renewal of DML for the following sections has been
Remarks of the Evaluator(IX) The label claim was film-coated tablet, but coating composition
and process are not mentioned in the application. The firm did
not clarify the same.
coating composition of the applied product and complete method
of manufacturing with the detail of coating process.
Evaluation by PEC The firm submitted that the tablet is uncoated. It was a typo
mistake in the label claim.
Evaluation by PEC The firm submitted Rs. 5000/- fee.
Decision: Approved.
Brand Name+ Dosage Form+ Zelotrine Tablet 5mg
Strength
Levocetirizine dihydrochloride…..5mg
PKR 20,000/-: 22.02.2018
Type of Form Form 5
Approval status of product in XYZAL levocetirizine hydrochloride 5 mg film coated tablet
Reference Regulatory Authorities blister pack. TGA approved
Me-too status Norzin 5 mg Tablets, film-coated. Reg. No. 77965
GMP status The firm provided inspection report dated 13.03.2019,
wherein the renewal of DML for the following sections has been
Remarks of the Evaluator(IX) The firm was asked to revise ‘Levoceterizine Dihydrochloride
equivalent to Levoceterizine’ to ‘Levocetirizine
Dihydrochloride’ in the label claim and master formula. The firm
neither revised the label claim nor revised the quantity of API to
5 mg in master formula.
Previous decision The Board in its 293rd meeting deferred the case for revision of
Evaluation by PEC  The firm submitted that there is no need to change.
 The firm needs to remove the equivalency in the label
claim.
 Regarding fee submission, the Registration Board is
humbly requested to clarify the fee submission in case of
pre-approval changes, as there is no written
guidelines/rules for such fee. Cases of similar nature
(adding or removing equivalency) have been approved
without fee submission in various meetings.
Previous decision The Board in its 295th meeting deferred the case for of label claim
and master formulation along with submission of requisite fee for
revision of formulation.
Evaluation by PEC The firm revised the master formulation and submitted Rs.
5000/- fee.
Decision: Approved.
Brand Name+ Dosage Form+ Zelotrine 2.5mg/5ml Syrup
Strength
Levocetirizine Dihydrochloride…..2.5mg
PKR 20,000/-: 22.02.2018
Type of Form Form 5
Pack Size & Demanded Price 60ml amber coloured bottle , As per SRO
Approval status of product in XYZAL (levocetirizine dihydrochloride) oral solution
Reference Regulatory Authorities 0.5mg/ml. USFDA approved
Me-too status T-Day Syrup 2.5mg/5ml. Reg. No. 83990
GMP status The firm provided inspection report dated 13.03.2019,
wherein the renewal of DML for the following sections has been
Remarks of the Evaluator(IX) The firm was asked to revise ‘Levoceterizine Dihydrochloride
equivalent to Levoceterizine’ to ‘Levocetirizine
Dihydrochloride’ in the label claim and master formula. The
firm neither revised the label claim nor revised the quantity of
API to 5 mg in master formula.
Previous decision The Board in its 293rd meeting deferred the case for revision of
Evaluation by PEC  The firm submitted that there is no need to change.
 The firm needs to remove the equivalency in the label
claim.
 Regarding fee submission, the Registration Board is
humbly requested to clarify the fee submission in case of
pre-approval changes, as there is no written
guidelines/rules for such fee. Cases of similar nature

have been approved without fee submission in various
meetings.
Previous decision The Board in its 295th meeting deferred the case for of label claim
and master formulation along with submission of requisite fee for
Evaluation by PEC The firm revised the master formulation and submitted Rs.
5000/- fee.
Decision : Approved with innovator’s specification.
948. Name and address of manufacturer Horizon Health care Private Limited
/ Applicant Plot No 35, Small industrial Estate, Taxila Pakistan
Brand Name +Dosage Form + Fleet Plus 75/75mg Tablet
Strength
Clopidogrel as bisulphate……………….75mg
Aspirin…………………………………..75mg
Rs. 20,000/- : 06.12.2018
Pharmacological Group Platelet aggregation inhibitors excl. heparin
Type of Form Form-5
Finished product Specification Innovator’s Specifications
Pack size & Demanded Price 10’s & 30’s; as per SRO
Approval status of product in APO-CLOPIDOGREL/ASPIRIN 75 mg / 75 mg film-coated
Reference Regulatory Authorities tablets. TGA approved
Me-too status Lowplat Plus 75 Tablet. Reg. no. 47177
GMP status OKK
 Form 5 has been signed by the manager regulatory affairs.
 The firm has mentioned clopidogrel as bilsulfate in the cover
letter, but the dossier does not depict the same elsewhere.
Upon clarification the firm revised clopidogrel to clopidogrel
as bisulfate without submission of any fee.
Submission of fee for revision / correction of salt form of the
API.
Submission of revised manufacturing method in line with that
of the reference product.
Evaluation by PEC The firm revised the aspirin to pellets of aspirin and submitted
RS. 5000/- fee.
 Submission of fee for revision / correction of salt form of the API.
 Clarification regarding revision of the aspirin to pellets of aspirin
 Clarification regarding the formulation, bilayer or otherwise.
Applicant Plot No 35, Small industrial Estate, Taxila Pakistan
Brand Name +Dosage Form + Strength RAFAZIN Tablet 200mg
Rifaximin………………………….200mg
Rs. 20,000/- : 06.12.2018
Pharmacological Group Antibiotics
Type of Form Form-5
Approval status of product in Reference XIFAXAN® (rifaximin) 200mg film-coated tablets, for oral use.
Me-too status Nimixa 200mg Tablet film-coated. Reg. No. 70734
GMP status AS ABOVE
 Form 5 has been signed by the manager regulatory affairs.
th
 The manufacturing outlines were meant for cream. The
firm revised the manufacturing outlines.
of manufacturing method of the applied product.
Evaluation by PEC The firm has already revised the manufacturing outlines.
Decision: Approved.
Brand Name +Dosage Form + Strength RAFAZIN Tablet 550mg
Rifaximin………………………….550mg
Rs. 20,000/- : 06.12.2018
Pharmacological Group Antibotics
Type of Form Form-5
Approval status of product in Reference XIFAXAN® (rifaximin) 550mg film-coated tablets, for oral use.
Me-too status NimIXa 550mg Tablet film-coated. Reg. No. 70733
GMP status AS ABOVE
Remarks of the Evaluator(IX)  Form 5 has been signed by the manager regulatory affairs.
 The manufacturing outlines were meant for cream. The
firm revised the manufacturing outlines.
of manufacturing method of the applied product.
Evaluation by PEC The firm has already revised the manufacturing outlines.
Decision: Approved.
Brand Name +Dosage Form + Strength TUKOL CR 25mg Tablet
Composition Each Enteric Coated Controlled Release Tablet Contains:
Paroxetine as HCl hemihydrate………………25mg
Rs. 20,000/- : 06.12.2018
Type of Form Form-5
Pack size & Demanded Price 10's; as per SRO
Approval status of product in Reference PAXIL CR (paroxetine) extended-release tablets, enteric coated
Regulatory Authorities (12.5mg, 25mg, 37.5mg). USFDA approved
Me-too status Approved
GMP status AS ABOVE
Remarks of the Evaluator(IX)  Form 5 has been signed by the manager regulatory affairs
 The firm did not mention seal coating and enteric coating
separately in the master formula as well as manufacturing
outlines.
 The firm revised the formulation to Enteric Coated
Controlled Release Tablet without submission of fee.
 Submission of fee for revision of formulation.
 Submission of revised master formulation and
manufacturing method in line with that of the reference
product.
Evaluation by PEC The firm submitted Rs. 5000/- fee, but did not clarify the
manufacturing process and composition. Moreover, Paroxetine

as HCl hemihydrate shall be mentioned instead of Paroxetine as
HCl.
 Clarification of the manufacturing process and composition.
 Revision of Paroxetine as HCl to Paroxetine as HCl hemihydrate
Brand Name +Dosage Form + Strength LYSINE 300mg Capsule
408mg of Lymecycline Equivalent to 300mg Tetracycline Base
(BP Specifications)
Rs. 20,000/- : 07.12.2018
Pharmacological Group Tetracyclines
Type of Form Form-5
Pack size & Demanded Price 10's, 14’s, 20’s, 28’s; as per SRO
Approval status of product in Reference Tetralysal 300 mg Hard Capsules. MHRA Approved
Me-too status Macyline Capsule 300mg. Reg. No.
GMP status AS ABOVE
Remarks of the Evaluator(IX) Form 5 has been signed by the manager regulatory affairs
Previous decision The Board in its 295th meeting deferred the case for confirmation
of label claim.
Evaluation by PEC The firm submitted references having same label claim as
applied.
Decision: Approved
953. Name and address of manufacturer Espoir Pharmaceuticals (Pvt) Ltd. PCSIR, TBIC II Pvt. Ltd
/ Applicant Karachi contract manufacturing by: M/s Mediate
Pharmaceuticals (Pvt) Ltd. Plot No. 150-151, Sector 24
Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Stazz Injection 250mg IV
Strength
Ceftriaxone Sodium Eq. to Ceftriaxone…250mg
Diary No. Date of R& I & fee Dy No. NIL: 11.06.2013 (duplicate dossier)
PKR 20,000/-: 11.06.2013
PKR 30,000/-: 16.06.2016
Type of Form Form 5
Approval status of product in Ceftriaxone 250mg (IV) by Lupin Pharmaceuticals Inc. US-
Reference Regulatory Authorities. FDA approved
Me-too status Ceftirains 250mg (ceftriaxone Sodium) I.V Injection by Sunrise
Pharma (Pvt) Ltd. Reg. No. 78655
GMP status The firm was inspected on 02.04.2019, wherein acceptable level
of GMP was reported.
Remarks of the Evaluator(IX).  Submit complete contract manufacturing agreement
between the applicant and manufacturer (as per SRO)
mentioning that which firm is contract giver and which one
is contract taker..
 Provide list of all approved products for contract
manufacturing by your firm, i.e., M/s Espoir Pharma.
 Provide list of all applied products for contract

 Provide list of all approved sections of you firm, i.e., M/s
Espoir Pharma.
Previous decision The Board in its 292nd meeting deferred the case for:
 Submit complete contract manufacturing agreement
mentioning that which firm is contract giver and which
one is contract taker.
Espoir Pharma.
 Contract manufacturing agreement
 That they have not applied for contract manufacturing
 That products have not registered for contract
manufacturing
Brand Name +Dosage Form + Stazz Injection 500mg IV
Strength
Ceftriaxone Sodium Eq. to Ceftriaxone…500mg
PKR 20,000/-: 11.06.2013
PKR 30,000/-: 16.06.2016
Type of Form Form 5
Approval status of product in Ceftriaxone 500mg (IV). US-FDA approved
Me-too status Wincef 500 mg (Ceftriaxone sodium) IV. Reg. No. 78097
is contract taker.
Espoir Pharma.

Espoir Pharma.
manufacturing
/ Applicant Karachi
Brand Name +Dosage Form + Stazz Injection 1g IV
Strength
Ceftriaxone Sodium Eq. to Ceftriaxone…1g
PKR 20,000/-: 11.06.2013
PKR 30,000/-: 16.06.2016
Type of Form Form 5
Approval status of product in Ceftriaxone 1 g (IV). US-FDA approved
Me-too status Martixon 1gm (Ceftriaxone sodium) I.V Dry powder Injection.
Reg. No. 70663
is contract taker.
Espoir Pharma.
Espoir Pharma.

manufacturing
 Decision: Approved
Brand Name +Dosage Form + Getfix 100mg/5ml dry suspension
Strength
Composition Each 5ml contain:
Cefixime as trihydrate……100mg
PKR 20,000/-: 11.06.2013
PKR 30,000/-: 16.06.2016
Type of Form Form 5
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension. MHRA
is contract taker..
Espoir Pharma.
Espoir Pharma.
manufacturing

Brand Name +Dosage Form + Getfix 200mg/5ml dry suspension
Strength
Composition Each 5ml contain:
PKR 20,000/-: 11.06.2013
PKR 30,000/-: 16.06.2016
Type of Form Form 5
Approval status of product in SUPRAX® (cefixime) for oral suspension. USFDA approved
is contract taker..
Espoir Pharma.
Espoir Pharma.
manufacturing
Brand Name +Dosage Form + Getfix Capsule 400mg
Strength
Composition Each capsule contain:
PKR 20,000/-: 11.06.2013
PKR 30,000/-: 16.06.2016

Type of Form Form 5
Approval status of product in SUPRAX® (cefixime) capsules, for oral use by Lupin Ltd for
Reference Regulatory Authorities. Lupin Pharma. Approved by US-FDA
Me-too status Nowcef 400mg Capsule by Nawan Lab. Karachi. Reg. No.
82219
is contract taker..
Espoir Pharma.
Espoir Pharma.
manufacturing
a. New DML
b. New/Additional section(s)

a. New Cases
b. Deferred Cases
959. Name and address of manufacturer/ M/s Selmore Pharmaceuticals Pvt Ltd. 36-Km, Multan Road
Applicant Lahore.
Brand Name + Dosage Form + Strength Solomox Powder
Amoxicillin as Trihydrate…70gm
PKR. 20,000/-; 02.10.2018

Pharmacological Group Penicillins with extended spectrum
Type of Form Form 5
Finished product Specification USP (for suspension, which shall contain one or more suitable
buffers, colors, flavors, preservatives, stabilizers, sweeteners and
suspending agents).
Pack size & Demanded Price 100g, 500g, 1kg, 5kg; Decontrolled
Me-too status Primox 70% Water Soluble Powder. Reg. No. 74032
GMP status The firm was inspected on 05.03.2018, 17.08.2018 & 16.10.2018
wherein Renewal of DML was recommended
 The USP monograph has specified that for suspension shall
contain one or more suitable buffers, colors, flavors,
preservatives, stabilizers, sweeteners and suspending agents).
The product does not contain such agents.
Previous decision The Board in its 293rd meeting deferred the case for clarification of
difference in composition of the applied formulation and the
composition described in individual monograph of the product (USP).
Evaluation by PEC The firm submitted that they have applied for product with BP
specifications.
Decision: approved with BP specifications.
960. Name and address of manufacturer / M/s Selmore Pharmaceuticals Pvt Ltd. 36-Km, Multan Road
Applicant Lahore
Brand Name +Dosage Form + Strength Trypnil Granules for Injection
Composition Each 2.36gm Sachet contains:
Diminazene Diaceturate…1.05g
PKR 20,000/-: 28.06.2018
Pharmacological Group Trypanocidal agent (not in ATC)
Type of Form Form 5
Pack size & Demanded Price 2.36g sachet; Decontrolled
Me-too status NAGANIL POWDER (Sachet). Reg. No. 26516
GMP status The firm was inspected on 05.03.2018, 17.08.2018 & 16.10.2018
wherein Renewal of DML was recommended.
(IX)
Remarks of the Evaluator . 
Previous decision The Board in its 291st meeting deferred the case for evidence of applied
formulation/drug already approved by DRAP (generic / me-too status)
Evaluation by PEC The firm submitted that they shall be granted registration in vial, as
vial is more suitable than scahet:
 Any variation (color or particles) of the contents of filled power
in sachet is not visible and the other hand is easily visible in vial.
 Volume after reconstitution is easily measurable in vial rather
than sachet.
 Sterility of product not possible in sachet.
 Particles not seen after reconstitution in sachet but visible in vial.
 Optical checking not possible in sachet.
Decision: Referred to working group on veterinary drugs.
961. Name and address of manufacturer / M/s Fresh Pharmaceuticals. Plot No. 7, Street No. S-6, National
Applicant Industrial Zone, Rawat, Islamabad
By
M/s Linta Pharmaceuticals Pvt Ltd. Plot No. 03, Street No S-5,
National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength F-Zix 400mg Capsule
Composition Each Hard Gelatin Capsule Contains:
PKR 50,000/-: 10.09.2018
Type of Form Form 5
Pack size & Demanded Price 1x5’s; as per DRAP Policy
Approval status of product in Reference SUPRAX® (cefixime) capsules, for oral. Approved by US-FDA
Me-too status Nowcef 400mg Capsule. Reg. No. 82219
GMP status Applicant: The firm was last inspected on 18.01.2018, wherein the
panel recommended the renewal of DML no. 000610 by way of
formulation.
Manufacturer: The firm was inspected on 12.06.2018, wherein the firm
was reported to be GMP complaint.
Remarks of the Evaluator(IX).  The firm M/s Fresh Pharmaceuticals did not submit list of
approved sections of M/s Fresh Pharmaceuticals.
 The firm M/s Fresh Pharmaceuticals did not submit list of
approved product for contract manufacturing.
 The firm M/s Fresh Pharmaceuticals submitted list of 03 applied
products for contract manufacturing.
Previous decision The Board in its 293rd meeting deferred for the following:
 Submission of list of approved sections of M/s Fresh
Pharmaceuticals.
 Submission list of approved products for contract manufacturing.
Evaluation by PEC  The firm submitted that they have no applied or registered
product for contract manufacturing and submitted list of 05
sections.
Decision: Approved.
By
Brand Name +Dosage Form + Strength F-Zix 100mg/5ml Dry Suspension
Composition Each 5ml of reconstituted Suspension Contains:
PKR 50,000/-: 10.09.2018
Type of Form Form 5
Approval status of product in Reference Cefixime 100 mg/5 ml Powder for Oral Suspension. MHRA approved
formulation.

Pharmaceuticals.
sections.
Decision: Approved.
By
Brand Name +Dosage Form + Strength F-Zix 200mg/5ml Dry Suspension
Composition Each 5ml of reconstituted Suspension Contains:
PKR 50,000/-: 10.09.2018
Type of Form Form 5
Approval status of product in Reference SUPRAX® (cefixime) for oral suspension. USFDA approved
formulation.
Pharmaceuticals.
sections.
Decision: Approved.
964. Name and address of manufacturer / Grand Pharma Pvt Ltd Plot No. 5-A, Street No. N5, National
Applicant Industrial Zone, Rawat, Rawalpindi
Brand Name + Dosage Form + Strength Tri-Pen LA Injection
Benzathine Pencillin G.…..…………….100,000 IU
Procaine Penicillin G………………..150,000 IU
Dihydrostreptomycin as sulphate…………..200 mg
Diary No. Date of R&I & Fee Dy. No. 21204: 18-10-2019, Rs. 20,000/-: 18-10.2019
Type of Form Form-5
Finished product Specification Manufacturer's specification
Pack size & Demanded Price 50ml; Decontrolled
Me-too status BPS-LA Injection (50ml). Reg. 080951

GMP status New Section Veterinary Liquid Injection Penicillin
Remarks of the Evaluator(IX)  Revise “Dihydrostreptomycin sulphate” to
“Dihydrostreptomycin as sulphate” in the label claim only
and adjust the weight of Dihydrostreptomycin sulphate in
Master formula as per salt factor.
Previous decision The Board in its 294th meeting deferred the case revision of
formulation including the salt form as per the DRAP approved
generic product along with submission of revised master formulation
and requisite fee.
Evaluation by PEC The frim submitted Rs. 5000/- fee. However, they did not revise
“Dihydrostreptomycin sulphate” to “Dihydrostreptomycin as
sulphate” in the label claim. In previous cases, the Board did not
demand fee for revision of API in terms of salt equivalency.
formulation as per the me-too product.
Evaluation by PEC The firm revised Dihydrostreptomycin sulphate to
Dihydrostreptomycin as sulphate in the label claim.
Decision: approved with innovator’s specifications.
965. Name and address of manufacturer/ M/s Hudson Pharma Private Limited. Site-Plot No. D-93, North
Applicant Western Industrial Zone, Port Qasim Authority, Pakistan
Brand Name + Dosage Form + Strength Easehale 0.025% Respules 1ml
Ipratropium bromide as monohydrate…0.025%
PKR. 20,000/-; 07.09.2018
Pharmacological Group Anticholinergics
Type of Form Form 5
Pack size & Demanded Price 5’sx1ml (Polyethylene); As per SRO
Approval status of product in Reference AERON 250 ipratropium bromide anhydrous 250 microgram/mL
Regulatory Authorities inhalation ampoule (LDPE). TGA approved, wherein active is
ipratropium bromide monohydrate 261 microgram/mL.
IPRATRIN UNI-DOSE ipratropium bromide monohydrate
250microgram/1mL inhalation ampoule. TGA approved
Me-too status Optra Nebuliser Solution. Reg. No. 57885
GMP status The firm was inspected on 03.04.2019, wherein acceptable level of
GMP compliance was reported.
Remarks of the Evaluator(IX)  The firm was asked to revise label claim to “Ipratropium
bromide as monohydrate. The firm did not revise the same.
Previous decision The Board in its 293rd meeting deferred the case for revision of label
claim to Ipratropium bromide as monohydrate as per the label claim of
Evaluation by PEC  The firm revised the label claim to Ipratropium bromide as
monohydrate.
Previous decision The Board in its 295th meeting deferred the case for submission of
requisite fee for revision of formulation.
Evaluation by PEC  The Board may review its decision.
Decision: Approved.
966. Name and address of Manufacturer/ M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial Triangle, Kahuta Road,
Applicant Islamabad
Brand Name + Dosage Form + Strength Super TD Powder 20/25g
Composition Each 100 gram contains:
Tylosin Tartrate…20g
Doxycycline hyclate…25g
Diary No. D of R & I & Fee Dy.No 1160: 09-01-2019
Rs. 20,000/-: 04-01-2019
Pharmacological group Antibiotics
Type of Form Form 5
Finished product Specifications Innovator’s specifications
Pack Size & demanded price As per SRO
Me-too status RAPID-TD WATER SOLUBLE POWDER (20%/25%). Reg. No. 75660
GMP Status As above
Remarks of Evaluator  Form 5 has been signed by the quality control manager.
 The firm had mentioned “Each gram contains: Tylosin
Tartrate…20g, Doxycycline hyclate…25g in the label claim and
Tylosin Tartrate…200g, Doxycycline HCl…250g per kg in
master formula. Upon clarification, the firm revised the label
claim to “Each 100 gram contains: Tylosin Tartrate…20g,
Doxycycline hyclate…25g” without submission of fee.
 Revision of Doxycycline HCl to Doxycycline hyclate in master
formula is required.
formulation alongwith applicable fee.
Evaluation by PEC: The firm revised Doxycycline HCl to Doxycycline hyclate in master
formula
Decision: Approved.
967. Name and address of Manufacturer / M/s Vetz Pharmaceutical (Pvt) Ltd Plot # Q-1, S.I.T.E, Kotri, Sindh
Applicant
Brand Name +DosageForm+Strength V-Mox LA 15 % Injection
Amoxicillin as trihydrate…….…..150 mg
PKR. 20,000/-; 17.12.2018
Pharmacological Group Penicillins
Types of Form Form-5
Finished Product Specification In-house specifications. The product is available in USP as powder for
injectable suspension.
Pack Size & Demanded Price 10 ml
Decontrolled
Me-too status Symox LA Injection (10ml, 50ml, 100ml). Reg. No. 058999
GMP status The firm was inspected on 26 & 27-7-2019 with the following
conclusion: Based on the above observation their current GMP
compliance level is rated as good.
Remarks of EvaluatorIX
Previous decision The Board in its 295th meeting deferred the case for clarification whether
product is long acting (as mentioned in brand name) or otherwise (as no
long acting claim in brand name) and confirmation of section.
Evaluation by PEC: The firm submitted letter of approval of sterile liquid injectable
penicillin (vet) section and submitted that the product is long acting.
Decision: Deferred for further deliberation regarding composition of long acting formulation.
Applicant
Brand Name +DosageForm+Strength Imivetz Injection
Imidocarb dipropionate…………120 mg
PKR. 20,000/-; 17.12.2018
Pharmacological Group Antiprotozoal agent
Finished Product Specification In-house specifications
Decontrolled
Me-too status Impisal Injection (10ml, 20ml, 30ml, 100ml). Reg. No. 063590

Remarks of EvaluatorIX Terminal sterilization is missing in the manufacturing outlines.
Provide me-too product (Name and registration number) with same
strength and filled volume approved by DRAP.
 Clarification of method of terminal sterilization/ sterile filling
process in manufacturing outlines.
 Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand
name and name of firm.
Evaluation by PEC:  The firm submitted revised manufacturing outlines.
Applicant
Brand Name +DosageForm+Strength Vitaflox 20 % Injection
Enrofloxacin ……..…..…..200 mg
PKR. 20,000/-; 17.12.2018
Pharmacological Group Fluoroquinolone
Decontrolled
Me-too status Enflox 20 % Injection (50ml, 100ml). Reg. no. 048153
IX
Remarks of Evaluator Terminal sterilization is missing in the manufacturing outlines.
Previous decision The Board in its 295th meeting deferred the case for clarification of
method of terminal sterilization/ sterile filling process in manufacturing
outlines.
Applicant
Brand Name +DosageForm+Strength Vetzphos Injection
Sodium acid phosphate…….…400 mg
PKR. 20,000/-; 24.12.2018
Pharmacological Group Phosphate deficiency (general tonic)
Finished Product Specification In-house specifications. Avaialable in USP as (Each mL contains:
Monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium
phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate,
heptahydrate, 268 mg); Water for Injection q.s. In the 5 mL and 15 mL
product, phosphoric acid and/or NaOH may have been added for pH
adjustment.)
Decontrolled
Me-too status Alphos-40 Injection (10ml, 20ml, 50ml, 100ml). Reg. No. 046573
Remarks of EvaluatorIX Provide me-too product (Name and registration number) with same
Terminal sterilization is missing in the manufacturing outlines.
Previous decision  The Board in its 295th meeting deferred the case for justification
and evidence of applied pack size.
Evaluation by PEC: The firm submitted the following dosage:
 Cattle / buffalo / horses: 200-250ml (IV single use for 250 ml)
 Sheep goat: 50-70ml
 Dogs/ cats: 10-20ml
 Camels: 300-350ml
Provide me-too product (Name and registration number) with same
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm.
Applicant
Brand Name +Dosage Form+Strength Veticam Plus Injectin
Meloxicam…………..…..20 mg
PKR. 20,000/-; 17.12.2018
Pack Size & Demanded Price 50ml; Decontrolled
Me-too status Metrym Injection (50ml, 100ml). Reg. no. 044961
IX
Remarks of Evaluator Terminal sterilization/ sterile filling process is missing in the
Previous decision The Board in its 295th meeting deferred the case for clarification of
method of terminal sterilization/ sterile filling process in manufacturing
outlines.
Applicant
Brand Name +DosageForm+Strength Aceclovetz Injection
Aceclofenac………. 25 mg
PKR. 20,000/-; 17.12.2018
Decontrolled
Me-too status Aceclovetz Injection (50ml). Reg. No. 084970
By same firm
Remark of Evaluator Provide me-too product (Name and registration number) with same
 The firm submitted me-too of Selmore Pharma, which is registered
as EACH ML CONTAINS: ACECLOFENAC SODIUM EQ.
TO ACECLOFENAC......25MG (50ml). However, the label has
aceclofenac (base)
Applicant
Brand Name +DosageForm+Strength Aminovetz injection 500ml
Dextrose …………………………….50 mg
Calcium chloride …………………….0.15mg
Potassium chloride…………………. 0.2mg
Magnesium Sulfate………………….. 0.2mg
Sodium acetate trihydrate …………2.5mg
L-Histidine HCl …..…………………..0.34mg
DL-Methionine ………………………0.34mg
DL-Tryptophan ………………………0.34mg
L-Cysteine HCl ………………………0.34mg
L-Threonine ………………………0.68mg
DL-Isoleucine ………………………0.68mg
L-Arginine HCl ………………………0.85mg
DL-Phenylalanine …………………….1.02mg
DL-Valine ……………………..1.7mg
L-Lysin HCl ……………………..1.02mg
L-Leucine …………………….1.36mg
Monosodium glutamate ……………1.36mg
Vitamin B1 (Thiamin HCl) ………….0.10mg
Vitamin B2 (Riboflavin-5-Phosphate).. 0.04mg
Vitamin B6 (Pyridoxine Hydrochloride)..0.1mg
Vitamin B12 (Cyanocobalamin) …..0.05mcg
Nicotinamide ……………………..1.5mg
PKR. 20,000/-; 17.12.2018
Pharmacological Group Amino Acid/ Electrolytes/ Vitamins
Decontrolled
Remark of Evaluator The composition do not match with the provided me-too.

 The revise the composition as follow along with submission of Rs.
20000/- dated 18.08.2020
Each ml contains Each 100ml contains
Dextrose ………50 mg Dextrose ……….5.5 mg
Calcium chloride ………0.15mg Calcium chloride ……15mg
Potassium chloride……… 0.2mg Potassium chloride…… 20mg
Magnesium Sulfate…… 0.2mg Magnesium Sulfate……… 20mg
Sodium acetate trihydrate …2.5mg Sodium acetate trihydrate
L-Histidine HCl …..…0.34mg …………250mg
DL-Methionine ……0.34mg L-Histidine HCl …..……34mg
DL-Tryptophan ……0.34mg DL-Methionine …………34mg
L-Cysteine HCl ……0.34mg DL-Tryptophan ………34mg
L-Threonine ……0.68mg L-Cysteine HCl ………34mg
DL-Isoleucine ……0.68mg L-Threonine ……68mg
L-Arginine HCl ……0.85mg DL-Isoleucine ………68mg
DL-Phenylalanine ……1.02mg L-Arginine HCl ……85mg
DL-Valine ……1.7mg DL-Phenylalanine ………102mg
L-Lysin HCl ……1.02mg DL-Valine ………170mg
L-Leucine ……1.36mg L-Lysin HCl ………102mg
Monosodium glutamate …1.36mg L-Leucine ………136mg
Vitamin B1 (Thiamin HCl) …0.10mg Monosodium glutamate
Vitamin B2 (Riboflavin-5- ……136mg
Phosphate).. 0.04mg Vitamin B1 (Thiamin HCl)
Vitamin B6 (Pyridoxine …10mg
Hydrochloride)..0.1mg Vitamin B2 (Riboflavin-5-
Vitamin B12 (Cyanocobalamin) Phosphate).. 4mg
…..0.05mcg Vitamin B6 (Pyridoxine
Nicotinamide ……1.5mg Hydrochloride)..10mg
Vitamin B12 (Cyanocobalamin)
…..5mcg
Nicotinamide ……150mg
Benzyl alcohol…1.5mg
Sterile water QS…100ml
The firm submitted the following me-too product, the composition of
varies from our me-too database.
Applicant
Brand Name +DosageForm+Strength Aminovetz injection 250ml
Dextrose …………………………….50 mg
Calcium chloride …………………….0.15mg
Potassium chloride…………………. 0.2mg
Magnesium Sulfate………………….. 0.2mg
Sodium acetate trihydrate …………2.5mg
L-Histidine HCl …..…………………..0.34mg
DL-Methionine ………………………0.34mg
DL-Tryptophan ………………………0.34mg
L-Cysteine HCl ………………………0.34mg
L-Threonine ………………………0.68mg
DL-Isoleucine ………………………0.68mg
L-Arginine HCl ………………………0.85mg
DL-Phenylalanine …………………….1.02mg
DL-Valine ……………………..1.7mg
L-Lysin HCl ……………………..1.02mg
L-Leucine …………………….1.36mg
Monosodium glutamate ……………1.36mg
Vitamin B1 (Thiamin HCl) ………….0.10mg
Vitamin B2 (Riboflavin-5-Phosphate).. 0.04mg
Vitamin B6 (Pyridoxine Hydrochloride)..0.1mg
Vitamin B12 (Cyanocobalamin) …..0.05mcg
Nicotinamide ……………………..1.5mg
PKR. 20,000/-; 17.12.2018
Pharmacological Group Amino Acid/ Electrolytes/ Vitamins
Decontrolled
Remark of Evaluator The composition do not match with the provided me-too.
 The revise the composition as follow along with submission of Rs.
20000/- dated 18.08.2020
Each ml contains Each 100ml contains
Dextrose ………50 mg Dextrose ……….5.5 mg
Calcium chloride ………0.15mg Calcium chloride ……15mg
Potassium chloride……… 0.2mg Potassium chloride…… 20mg
Magnesium Sulfate…… 0.2mg Magnesium Sulfate……… 20mg
Sodium acetate trihydrate Sodium acetate trihydrate
…2.5mg …………250mg
L-Histidine HCl …..…0.34mg L-Histidine HCl …..……34mg
DL-Methionine ……0.34mg DL-Methionine …………34mg
DL-Tryptophan ……0.34mg DL-Tryptophan ………34mg
L-Cysteine HCl ……0.34mg L-Cysteine HCl ………34mg
L-Threonine ……0.68mg L-Threonine ……68mg
DL-Isoleucine ……0.68mg DL-Isoleucine ………68mg
L-Arginine HCl ……0.85mg L-Arginine HCl ……85mg
DL-Phenylalanine ……1.02mg DL-Phenylalanine ………102mg
DL-Valine ……1.7mg DL-Valine ………170mg
L-Lysin HCl ……1.02mg L-Lysin HCl ………102mg
L-Leucine ……1.36mg L-Leucine ………136mg
Monosodium glutamate …1.36mg Monosodium glutamate
Vitamin B1 (Thiamin HCl) ……136mg
…0.10mg Vitamin B1 (Thiamin HCl)
Vitamin B2 (Riboflavin-5- …10mg
Phosphate).. 0.04mg

Vitamin B6 (Pyridoxine Vitamin B2 (Riboflavin-5-
Hydrochloride)..0.1mg Phosphate).. 4mg
Vitamin B12 (Cyanocobalamin) Vitamin B6 (Pyridoxine
…..0.05mcg Hydrochloride)..10mg
Nicotinamide ……1.5mg Vitamin B12 (Cyanocobalamin)
…..5mcg
Nicotinamide ……150mg
Benzyl alcohol…1.5mg
Sterile water QS…100ml
The firm submitted the following me-too product, the composition of
varies from our me-too database.

a. New Cases (Human)
b. New Cases (Veterinary)
c. Deferred cases
i. Human
ii. Veterinary
975. Name and address of Applicant M/s Schiwo Pakistan, 11G, Shah Rukh e Alam Colony, Multan
Detail of Drug Sale License Address: 11G, Shah Rukh e Alam Colony, District Multan
Godown: House No. 24/C, Loha Market, Vehari Road, Near Metro
Station, People Colony Multan
License No. 04-361-0171-0926D vaild till: 26.08.2019
Name and address of Manufacturer M/s Asifac Viet Pharma Co. Ltd. 220 Pham The Hein St.,Dist.8, Ho
Chi Minh City, Vietnam
Factory: Raod No. 5, Giang Dien Industrial Zone, Trang Bom Dist.,
Dong Nai.
Name and address of marketing M/s Asifac Viet Pharma Co. Ltd. 220 Pham The Hein St.,Dist.8, Ho
authorization holder Chi Minh City, Vietnam
Factory: Road No. 5, Giang Dien Industrial Zone, Trang Bom Dist.,
Dong Nai.
Name of exporting country Vietnam
Diary No. Date of R& I Dy No.23258: 05.07.2018
Fee including differential fee PKR 100,000/-: 05.07.2018

Brand Name +Dosage Form + Asi-Tydox Plus Powder
Strength
Composition Each 1000g Contains:
Doxycycline Hyclate…200g
Finished Product Specification Not provided
Pack size & Demanded Price 1 kg; Rs. 10500/-
Approval status of product in NA
Me-too status TYLODOX 100/200 W.S. POWDER. Reg No. 43595
Detail of certificate attached  Legalized copy of FSC issued by Department of Animal Health
of Vietnam valid for two years from 30.07.2018. Only brand
name has been mentioned without label claim.

 Legalized copy of GMP certificate issued by Department of
Animal Health of Vietnam for five years from 23.1.2017.
 Letter of authorization is provided.
Remarks of the Evaluator(IX).  First page of Form 5A was from manufacturer not importer
and had not been signed. The firm submitted revised first
page of Form 5.
 The firm was asked to submit certificate of analysis. The
firm did not submit the same.
 Only brand name has been mentioned without label
claim.
 The firm has provided stability summary sheets, wherein
description, identification, loss on drying and assay have
been performed as per Zone IV-A. However, USP general
chapter has mentioned description, identification, assay and
impurities for universdal tests. Furthermore, USP has
mentionedadditional tests for powder as:
“Oral powders should indicate: "For Oral Use Only". Tests that
are considered specific to the type of powders include:
Minimum Fill (755) and volatile content ((731) and (921)).
Minimum Fill (755) has specifications that apply to oral
powders. On the basis of the nature of the article and scientific
criteria, additional tests may apply, including pH in an aqueous
solution, powder fineness, microbial limits, and others.
Previous decision The Board in its 291st meeting deferred the case for:
 Submission of testing method and certificate of analysis.
 Submission of Original legalized and valid FSC with label
claim of the product.
Evaluation by PEC  The firm changed the address in form 5 from “M/s Schiwo
Pakistan. Office No. 10, First Floor, City Plaza, Khanewal
Road, Chowk Rasheedabad, Multan, Punjab” to “M/s
Schiwo Pakistan, 11G, Shah Rukh e Alam Colony, Multan.
 The firm submitted the testing method and CoA.
 The firm submitted Legalized copy of FSC issued by
Department of Animal Health of Vietnam valid for two
years from 26.09.2019.
Previous decision The Board in its 293rd meeting deferred the case for changing the
address of applicant in form 5A.
Evaluation by PEC  The firm submitted Rs. 5000/- fee.
Previous decision  The Board in its 293rd meeting deferred the case for:
regulatory authorities/agencies which were
meeting.
Evaluation by PEC  The me-too staus had already been mentioned as above.
Another me-too is:
DOXYSIN WATER SOLUBLE POWDER. Reg. No. 33256
Decision: Approved as per Policy for inspection of Manufacturer abroad.
Evaluator-PEC-VII
Item No. I: Cases Related to Covid-19 Management.

Drug Regulatory Authority of Pakistan in its 85th meeting held on 09th June, 2020 discussed Favipiravir
use in COVID-19 management by countries like China, Russia & Saudi Arabia and further its approval
in Japan as antiviral against influenza viruses. Keeping in view the current outbreak of COVID-19, the
Authority allowed to submit registration applications on Form 5/ Form 5-A/ Form 5-D instead of Form
5F for registration of Favipiravir.
The Authority in the said meeting advised Director (PE&R) to consider the applied registration
applications of Favipiravir in the ongoing meeting without waiting for the formal minutes of the Authority.
1. The applicants can submit their applications till 31-07-2020 and these applications will be
considered out of queue.
2. Registration Board shall consider grant of registration under proviso of Rules 29(6) (8) of the
Drug (Licensing, Registration & Advertising) Rules, 1976 and shall follow precautions / terms &
conditions as adopted by the Reference Regulatory Authorities.
3. The registration holders including those granted registration under Form 5D as a new drug will
submit data of product development and 6 months accelerated and 6 months real time stability
studies data within one year alongwith other data as may be required by Registration Board. The
data will be considered by Registration Board for further decision.
Keeping in view the above decision and directions of the Authority; the Board considered following
applications of Favipiravir and decided as mentioned against each:
1. Favipiravir Tablet 200mg:
Composition
Favipiravir…………….200mg
Availability in RRA: Avigan 200mg Film coated Tablet by M/s Toyama Chemical Co., Ltd Japan (PMDA
Approved)
Me too status: Not confirmed
Pharmacological group: Antiviral
Specifications: Innovator‟s specifications
S. Name of Brand compositio Diary no. Pack Remarks/GMP Decision

No. applicant Name n Date /Fee & size/ status
Date/ form Price
976. M/s. Nawan Aviwan Each Film Dy.No. As per Good Approved with
Laboratories 200mg Coated 13477 dated SRO compliance of innovator’s
(Pvt) Ltd. Tablet Tablet 11/06/2020 GMP, inspection specification.
136 sector 15 Contains: Rs. 50,000/- date 26/12/2019.
Korangi Favipiravir dated 11-06-
Industrial …200mg 2020
Area Karachi. (#2037902)
Form 5D
977. M/s Covigon Each Film Dy.No. As per The panel Approved with
Scotmann 200mg Coated 13954 dated SRO recommended innovator’s
Pharmaceutic Tablet Tablet 17/06/2020 grant of GMP specification.
als. Contains: Rs. 50,000/- certificate,
5-D, I-10/3, Favipiravir dated 17-06- inspection date
Industrial … 2020 10/10/2018 &
Area, 200mg (#2037453) 17/10/2018.
Islamabad Form 5D
978. M/s Saffron Safvir Each Film Dy.No. As per Last GMP Approved with
Pharmaceutic 200mg Coated 13660 dated SRO inspection innovator’s
als (Pvt) Ltd. tablet Tablet 15/06/2020 conducted on specification.
19 Km Contains: Rs. 50,000/- 08-10-2019, and
Sheikhupura Favipiravir dated 15-06- the report
Road, … 2020 concludes that
Faislabad 200mg (#0228324) the firm is
Form 5D considered to be
operating at

Good level of
compliance with
GMP guidelines
979. M/s Bio Labs Favip Each Film Dy.No. 14’s. GMP certificate Approved with
Pvt Ltd. 200mg Coated 13663 dated 28’s issued on innovator’s
Plot # 145, Tablet Tablet 15/06/2020 As per 21/05/2019 on specification.
Industrial Contains: Rs. 50,000/- SRO the basis of
Triangle, Favipiravir dated 15-06- inspection
Kahuta Road, …200mg 2020 conducted on
Islamabad (#2030754) 23/04/2019.
Form 5D
980. M/s Shaigan Favigan Each Film Dy.No. 14’s. 25-9-2019 Panel Approved with
Pharmaceutic 200mg Coated 14132 dated 28’s recommended innovator’s
als (Pvt) Ltd. Tablet Tablet 18/06/2020 As per the renewal of specification.
14 KM Contains: Rs. 50,000/- SRO DML
Adyala Raod Favipiravir dated 18-06-
Post Office …200mg 2020
Daghal, (#2031388)
Rawalpindi Form 5D
981. M/s Neutro Favip Each Film Dy.No. As per GMP certificate Approved with
Pharmaceutic 200mg Coated 14519 dated SRO issued on 11-07- innovator’s
als Pvt Ltd. Tablet Tablet 23/06/2020 2019 on the specification.
9.5-km Contains: Rs. 50,000/- basis of
sheikhupura Favipiravir dated 23-06- inspection
Road, Lahore, …200mg 2020 Form conducted on
Pakistan 5D 28/02/2019
982. M/s Global Xovir Each Film Dy.No. 10’s. Inspection date Deferred for
Pharmaceutic 200mg Coated 13957 dated 20’s 26/12/2018, submission of
als Pvt Ltd Tablet Tablet 17/06/2020 30’s panel Form 5D along
Plot # 204- Contains: Rs. 20,000/- As per recommended with the
205, Favipiravir dated 17-06- SRO renewal of submission of
Industrial …200mg 2020 DML. Differential fee of
Triangle, (#2031650) (Differential fee Rs. 30,000/-
Kahuta Road, Form 5 of Rs. 30,000/-
Islamabad is required to be
submitted)
983. M/s Martin Frovir Each Film Dy.No. As per The firm was Approved with
Dow Limited. 200mg Coated 13952 dated SR operating at innovator’s
Plot No. 37, Tablet Tablet 17/06/2020 good level of specification.
Sector 19, Contains: Rs. 50,000/- compliance with
Korangi Favipiravir dated 17-06- GMP as per
Industrial …200mg 2020 inspection report
Area, Karachi (# 2041711) dated
Form 5D 06/12/2018.
984. M/s Medisure Fast Each Film Dy.No. As per GMP Certificate Approved with
Laboratories 200mg Coated 13775 dated SRO Issued to innovator’s
Pakistan Pvt Tablet Tablet 16/06/2020 Medisure specification.
Ltd. Contains: Rs. 50,000/- Labortaries
A-115, Favipiravir dated 16-06- Pakistan Pvt Ltd
S.I.T.E, Super … 2020 Karachi on 02-
Highway, 200mg (#2042103) 10-2019
Karachi, Form 5D
Pakistan

985. M/s Farivir Each Film Dy.No. 10’s. Last inspection Approved with
Nabiqasim 200mg Coated 13771 dated 30’s, dated 05-08- innovator’s
Industries Pvt Tablet Tablet 16/06/2020 100 ’s 2019 concluded specification.
Ltd. Contains: Rs. 50,000/- As per acceptable level
17/24, Favipiravir dated 16-06- SRO of GMP
Korangi …200mg 2020 compliance
Industrial (#2040652)
Area, Form 5D
Karachi,
Pakistan
986. M/s Genome Fapavir Each Film Dy.No. As per The firm was Approved with
Pharmaceutic 200mg Coated 14224 dated SRO inspected on innovator’s
als Pvt Ltd. Tablet Tablet 19/06/2020 12/05/18 specification.
Plot # 16/I- Contains: Rs. 50,000/- concluding
Phase IV, Favipiravir dated 19-06- Good level of
Industrial …200mg 2020 cGMP.
Estate, Hattar, (#2037883)
KPK Form 5D
987. M/s Macter Favimac Each Film Dy.No. 14’s. Inspection Approved with
International 200mg Coated 14225 dated 28’s conducted on innovator’s
Limited. tablet Tablet 19/06/2020 As per 23-01-2019 specification.
F-216, Contains: Rs. 50,000/- SRO concludes the
S.I.T.E, Favipiravir dated 19-06- firm is
Karachi, … 2020 considered to be
Pakistan 200mg (#2027121) operating at
Form 5D good level of
GMP.
988. M/s Radiant Fapa-v Each Film Dy.No. As per GMP certificate Approved with
Pharma Pvt 200mg Coated 14517 dated SRO issued on innovator’s
Ltd. Tablet Tablet 23/06/2020 11/07/2019 on specification.
43-E, Sundar Contains: Rs. 50,000/- the basis of
Industrial Favipiravir dated 23-06- inspection
Estate, …200mg 2020 conducted on
Lahore (#2027682) 31/07/2018.
Form 5D
989. M/s Barrett Favibar Each Film Dy.No. 10’s. Last GMP Approved with
Hodgson 200mg Coated 14851 dated 20’s inspection was innovator’s
Pakistan Pvt Tablet Tablet 25/06/2020 30’s. conducted on specification.
Ltd. Contains: Rs. 50,000/- 40’s 29-03-2019 and
F/423, SITE, Favipiravir dated 25-06- As per the report
Karachi … 2020 SRO concludes
200mg (#2027714) satisfactory
Form 5D level of GMP
compliance.

990. M/s Magns Virag Each Film Dy.No. 10’s Last GMP Approved with
Pharmaceutic 200mg Coated 14849 dated 30’s. inspection was innovator’s
als. Tablet Tablet 25/06/2020 As per conducted on specification.
Plot No. 7-B, Contains: Rs. 50,000/- SRO 07-12-2017
Value Favipiravir dated 25-06- Conclusion: M/s
Addition City …200mg 2020 Magns
Faisalabad (#0806415) Pharmaceuticals
Form 5D Faisalabad was
considered to be
operating at
good level of
compliance with
GMP
compliance of
the firm.
991. M/s Jinnah Jp-Favor Each Film Dy.No. As per The panel Approved with
Pharmaceutic 200mg Coated 14850 dated SRO recommended innovator’s
als Pvt Ltd. Tablet Tablet 25/06/2020 renewal of specification.
13 km, Contains: Rs. 20,000/- DML,
Lahore Road, Favipiravir dated 24-06- inspection date
Multan …200mg 2020 03/05/2019.
(#2000257) +
30,000/-
dated 15-7-
2020
(#2046466)
Form 5D
992. M/s Welwink Favink Each Film Dy.No. As per Last GMP Deferred for
Pharmaceutic 200mg Coated 14247 dated SRO inspection submission of
als. Tablet Tablet 24/06/2020 conducted on Form 5D along
Factory G.T. Contains: Rs. 20,000/- 20-12-2017 and with the
Road, Favipiravir dated 22-06- report concludes submission of
Industrial … 2020 that the panel Differential fee of
Estate, 200mg (#2048488) concluded that Rs. 30,000/-
Gujranwala Form 5 the firm was
Cantt. operating at
satisfactory
level of GMP
compliance for
all sections
except liquid
injectable
section for
which the firm
was advised to
provide liquid
particle counter
and TOC at
earliest.”
(Differential fee
of Rs. 30,000/-
is required to be
submitted)

993. M/s Novamed Vicor Each Film Dy.No. 10’s. Last GMP Approved with
Pharmaceutic 200mg Coated 14741 dated 20’s inspection dated innovator’s
als (Pvt) Ltd. Tablet Tablet 24/06/2020 30’s. 5th & 27th specification.
28- Contains: Rs. 50,000/- 40’s December
km,Ferozepur Favipiravir dated 24-06- 50’s. conclusion by
Road, Lahore …200mg 2020 100’s Panel “The firm
(#2041345) (M/s NovaMed
Form 5D Pharmaceuticals
As per Pvt. Ltd.
SRO Lahore) is
compliant to
Good cGMP
guidelines at the
time of
inspection”
994. M/s Hamaz Hamivir Each Film Dy.No. As per GMP certificate Approved with
Pharmaceutic 200mg Coated 14744 dated SRO issued on innovator’s
als Pvt Ltd. Tablet Tablet 24/06/2020 06/11/2019. specification.
Business City Contains: Rs. 50,000/-
Plaza, Hall # Favipiravir dated 24-06-
1, 2nd Floor, …200mg 2020
Bosan Road, (#2048952)
Multan, Form 5
Pakistan
995. M/s Innvotek Favira or Each Film Dy.No. 14’s. Last inspection Approved with
Pharmaceutic Antvir Coated 14515 dated 28’s dated 19-7-2017 innovator’s
als. 200mg Tablet 23/06/2020 As per recommends specification.
35-Industrial Tablet Contains: Rs. 50,000/- SRO grant of DML
Triangle, Favipiravir dated 23-06-
Kahuta Road, … 2020
Islamabad 200mg (#0748300)
Form 5D
996. M/s Martin Fabivir Each Film Dy.No. As per Last GMP Approved with
Dow Marker 200mg Coated 14354 dated SRO inspection was innovator’s
Limited. Tablet Tablet 22/06/2020 conducted on specification.
7, Jail Road, Contains: Rs. 50,000/- 12-07-2019 and
Quetta, Favipiravir dated 22-06- the report
Pakistan …200mg 2020 concludes good
(#2032561) level of GMP
Form 5D compliance.
997. M/s The Copravir Each Film Dy.No. As per Inspection date Approved with
Schazoo 200mg Coated 15046 dated SRO 30/05/2019, innovator’s
Pharmaceutic Tablet Tablet 26/06/2020 good level of specification.
al Contains: Rs. 20,000/- GMP
Laboratories Favipiravir dated 26-06- compliance.
Pvt Ltd. … 2020
Kalalwala 200mg (#1924016) +
Stop, 20 km 30,000/-
Lahore- (#1924026)
Jaranwala Form 5D
Road, Distt
Sheikhupura,
Pakistan

998. M/s Amarant Favirant Each Film Dy.No. 10’s. Good GMP Approved with
Pharmaceutic 200mg Coated 15046 dated 30’s. compliance, innovator’s
als Pvt Ltd. Tablet Tablet 24/06/2020 40’s inspection date specification.
158-D, Tore, Contains: Rs. 50,000/- 100’s 24/07/2018
Gadap Road, Favipiravir dated 24-06- As per
Super …200mg 2020 SRO
Highway, (#2024222)
Karachi Form 5D
999. M/s High Vipra Each Film Dy.No. 14’s. The firm has Approved with
noon 200mg Coated 14130 dated 28’s been granted innovator’s
Laboratories Tablet Tablet 18/06/2020 As per GMP certificate specification.
Ltd. Contains: Rs. 50,000/- SRO based upon
17.5 km, Favipiravir dated 18-06- evaluation
Multan Road, …200mg 2020 conducted on
Lahore (Form 5D 06-7-2017
1000. M/s Vision Favigan Each Film Dy.No. 10’s. Inspection date Approved with
Pharmaceutic 200mg Coated 15168 dated As per 11/02/2019, the innovator’s
als. Tablet Tablet 29/06/2020 SRO panel specification.
Plot # 22,23, Contains: Rs. 50,000/- recommended
Industrial Favipiravir dated 29-06- issuance of
Triangle, …200mg 2020 GMP certificate
Kahuta Road, (#2028815)
Islamabad Form 5D
1001. M/s MKB Avigon Each Film Dy.No. 10’s. Inspection dated Approved with
Pharmaceutic 200mg Coated 15173 dated 30’s 24-01-2019 innovator’s
als Pvt Ltd. Tablet Tablet 29/06/2020 100’s concludes that specification.
66-Hayatabad Contains: Rs. 50,000/- As per the firm is
Industrial Favipiravir dated 29-06- SRO operating at
Estate, … 2020 satisfactory
Peshawar, 200mg (0719939) level of GMP
Kpk, Pakistan Form 5D compliance.
1002. M/s Frovir Each Film Dy.No. As per The firm is Deferred for
Winbrains 200mg Coated 15171 dated SRO granted GMP submission of
Research Tablet Tablet 29/06/2020 certificate based Form 5D along
Laboratories. Contains: Rs. 20,000/- on inspection with the
Plot No. 69/1, Favipiravir dated 29-06- dated 20-05- submission of
Block B, … 2020 2019. Differential fee of
Phase I-II, 200mg (#2040311) (Differential fee Rs. 30,000/-
Industrial Form 5 of Rs. 30,000/-
Estate, Hattar, is required to be
Pakistan submitted)

1003. M/s Variant Favirant Each Film Dy.No. As per Inspection Approved with
Pharmaceutic 200mg Coated 15170 dated SRO report dated 09- innovator’s
als Pvt Ltd. Tablet Tablet 29/06/2020 12-2019 & 20- specification.
Plot No 05, Contains: Rs. 50,000/- 12-2019, the
M-2 Favipiravir dated 29-06- firm is granted
Pharmazone, … 2020 DML by way of
26 Km, Main 200mg (# 0797740) formulation.
Sharaqpur Form 5D
Road,
Shiakhupura,
Pakistan
1004. M/s Coinzav Each Film Dy.No. 14’s. GMP inspection Approved with
Standpharm ir 200mg Coated 16422 dated 28’s date d19-10- innovator’s
Pakistan Pvt. Tablet Tablet 08/07/2020 As per 2017 specification.
Ltd. Contains: Rs. 50,000/- SRO satisfactory
20-km, Favipiravir dated 08-07- level of
Ferozepur … 2020 compliance.
Road, Lahore 200mg (#2042503)
Form 5D
1005. M/s Zafa Favipir Each Film Dy.No. As per GMP certificate Approved with
Pharmaceutic 200mg Coated 16425 dated SRO issued on the innovator’s
als Tablet Tablet 08/07/2020 basis of specification.
Laboratories Contains: Rs. 50,000/- inspection dated
Private Favipiravir dated 08-07- 23.05.2018
Limited. …200mg 2020
L-1/B, Block- (#1929675)
22, Federal B Form 5D
industrial
Area, Karachi
1006. M/s Siam Fabi Flu Each Film Dy.No. 7’s. 16-02-2018 Approved with
Pharmaceutic 200mg Coated 16551 dated 10’s. Keeping in view innovator’s
al Tablet Tablet 09/07/2020 14’s. the above facts specification.
217, Contains: Rs. 50,000/- 20’s. on record, the
Industrial Favipiravir dated 09-07- ,28’s, panel
Triangle, …200mg 2020 30’s unanimously
Kahuta Road, (#2043375) As per recommend
Islamabad Form 5D SRO grant renewal of
DML 000711
for approved
tablet general
and Capsule
general section,
to M/s Siam
Pharmaceuticals
Islamabad

1007. M/s Maple Favirase Each Film Dy.No. 100’s GMP certificate Approved with
Pharmaceutic 200mg coated 16552 dated As per issued on innovator’s
al Pvt Ltd. Tablet Tablet 09/07/2020 SRO 22/01/2020 on specification.
Plot No 147, Contains: Rs. 50,000/- basis of
Sector 23, Favipiravir dated 09-07- inspection
Korangi …200mg 2020 conducted on
Industrial (#2001190) 22/12/2020.
Area, Form 5
Karachi,
74900,
Pakistan
1008. M/s Ameer Am-Vir Each Film Dy.No. 10’s. 9-12-2019 panel Approved with
Pharma. 200mg Coated 15113 dated 20’s, recommend innovator’s
23 KM- tablet Tablet 29/06/2020 30’s. renewal of DML specification.
Sheikhupura Contains: Rs. 20,000/- 40’s
Road, Lahore Favipiravir (#2001315) + 50’s.
…200mg 30,000/- 100’s
(2001321) As per
dated 29-06- SRO
2020 Form
5D
1009. M/s Wilson's Fav-200 Each Film Dy.No. As per 24-01-2018 Approved with
Pharmaceutic Tablet Coated 15860 dated SRO Good level of innovator’s
als. Tablet 03/07/2020 CGMP specification.
387-388, I-9, Contains: Rs. 20,000/- Compliance.
Industrial Favipiravir dated 02-07- (Differential fee
Area, … 2020 of Rs. 30,000/-
Islamabad 200mg (#2029300) is required to be
Form 5 submitted)
1010. M/s Fassgen Novel- Each Film Dy.No. As per Inspection Deferred for
Pharmaceutic Vir Coated 15803 dated SRO report dated submission of
als 200mg Tablet 02/07/2020 14/11/2017, 15 Form 5D along
Plot No. Tablet Contains: Rs. 20,000/- recommendation with the
67/1A, Favipiravir dated 02-07- s were made submission of
Phase-III, …200mg 2020 regarding QC, Differential fee of
Industrial (#2000218) production, Rs. 30,000/-
Estate, Hattar Form 5 microbiological
lab, cleaning
validation,
stability
chambers etc.
(Differential fee
of Rs. 30,000/-
is required to be
submitted)

1011. M/s Kaizen Recovir Each Film Dy.No. 10’s. The inspection Approved with
Pharmaceutic 200mg Coated 16007 dated 20’s, report dated innovator’s
als Pvt Ltd. Tablet Tablet 06/07/2020 30’s. 02.07.2019 specification.
E-127-129, Contains: Rs. 50,000/- 50’s concluded
North Favipiravir dated 06-07- satisfactory
Western …200mg 2020 As per level of GMP
Industrial (#0805592) SRO compliance.
Zone, Bin Form 5D
Qasim,
Karachi
1012. M/s Maxitech Favigan Each Film Dy.No. As per The firm was Deferred for
Pharma Pvt 200mg Coated 15707 dated SRO inspected on 21- submission of
Ltd. Tablet Tablet 02/07/2020 02-2019 Form 5D along
Plot No. E- Contains: Rs. 20,000/- GMP with the
178, S.I.T.E. Favipiravir dated 02-07- compliance submission of
Super … 2020 level is rated as Differential fee of
Highway, 200mg (#1956479) Good. Rs. 30,000/-
Phase II, 30,000/- Form 5D not
Karachi (#2036909) submitted
Form 5
1013. M/s Genix Favip Each Film Dy.No. 10’s. Last inspection Approved with
Pharma Pvt 200mg Coated 16553 dated 20’s dated 10-04- innovator’s
Ltd. Tablet Tablet 09/07/2020 14’s. 2019 concluded specification.
44,45-B, Contains: Rs. 50,000/- 28’s acceptable level
Korangi Favipiravir dated 09-07- 30’s. of GMP
Creek Road, …200mg 2020 100’s compliance
Karachi, (#2030652) As per
75190, Form 5D SRO
Pakistan
1014. M/s ICI Fluvir Each Film Dy.No. 20’s, Last GMP Approved with
Pakistan 200mg Coated 16003 dated 30’s, inspection (M/s innovator’s
Limited., Tablet Tablet 06/07/2020 40’s ICI Pakistan) specification.
32/2A, Contains: Rs. 50,000/- As per was conducted
Industrial Favipiravir dated 29-06- SRO on 25-
Estate, Hattar …200mg 2020 01-2018 and the
(#2037761) report concludes
Form 5D the firm to be
GMP
Compliant.
1015. M/s Medizan Favix Each Film Dy.No. 7’s. Last GMP Approved with
Laboratories 200mg Coated 16708 dated 10’s, inspection innovator’s
(Pvt) Ltd, Plot Tablet Tablet 10/07/2020 14’s. conducted on specification.
No. 313, Contains: Rs. 50,000/- 20’s, 20-11-2017 firm
Industrial Favipiravir dated 10-07- 28’s. was considered
Triangle, …200mg 2020 30’s, to be operating
Kahuta road, (#2040583) 40’s. at reasonably
Islamabad Form 5D 50’s, acceptable
100’s. compliance with
As per GMP guidelines
SRO as of today.

1016. M/s EG Fabi Flu Each Film Dy.No. As per Renewal of Approved with
Pharmaceutic 200mg Coated 17063 dated SRO DML innovator’s
als. Tablet Tablet 14/07/2020 recommended in specification.
Plot. No. 13- Contains: Rs. 20,000/- the inspection
A, Industrial Favipiravir dated 14-07- dated 13-02-
Triangle, …200mg 2020 2019
Kahuta Road, (#2040294)
Islamabad 30,000/- (#
1926152)
dated 7-09-
2020
Form 5D
1017. M/s Crystolite Faravir Each Film Dy.No. 20’s. Crystollite Approved with
Pharmaceutic 200mg Coated 17064 dated 30’s Pharma: Panel innovator’s
als. Tablet Tablet 14/07/2020 100’s Inspection for specification.
Plot # 1 & 2, Contains: Rs. 20,000/- As per renewal of DML
Street S-2, Favipiravir (#1936990) SRO conducted on
National … dated 14-07- 12-11-2018 &
Industrial 200mg 2020 + 02-01-2019
Zone, Rawat, 30,000/- unanimously
Islamabad (#2041013) recommends the
dated 19-08- renewal of DML
2020 Form
5D
1018. M/s Horizon Favira Each Film Dy.No. 20’s. GMP Certificate Approved with
Healthcare 200mg Coated 17305 dated 40’s issued on the innovator’s
(Pvt) Ltd. Tablet Tablet 16/07/2020 As per basis of GMP specification.
Plot No. 33, Contains: Rs. 50,000/- SRO inspection
Sundar Favipiravirdated 16-07- conducted on 1-
Industrial … 2020 03-2019
Estate, 200mg (#2037402)
Lahore Form 5D
1019. M/s Vega Vevir Each Film Dy.No. As per Inspection dated Approved with
Pharmaceutic 200mg Coated 17572 dated SRO 21-03-2019 the innovator’s
als Pvt Ltd. Tablet Tablet 20/07/2020 firm is specification.
Plot No. 4, Contains: Rs. 50,000/- considered to be
30-Km Favipiravir dated 20-07- operating at fair
Pharma City, …200mg 2020 (# level of GMP
Multan Road, 1956668) compliance.
Lahore Form 5D
1020. M/s Hygeia Hypiravi Each Film Dy.No. 10’s. GMP inspection Deferred for
Pharmaceutic r 200mg Coated 17711 dated As per conducted on submission of
als. Tablet Tablet 21/07/2020 SRO 21-09-2017, the Form 5D along
Plot No. 295, Contains: Rs. 20,000/- firm is with the
Industrial Favipiravir dated 20-07- considered to be submission of
Triangle, …200mg 2020 operating at Differential fee of
Kahuta Road, (#2039204) satisfactory Rs. 30,000/-
Islamabad Form 5 level of
compliance.
(Differential fee
of Rs. 30,000/-
is required to be
submitted)

1021. M/s High-Q Favid Each Film Dy.No. As per Last GMP Deferred for
Pharmaceutic 200mg Coated 17714 dated SRO inspection submission of
als. Tablet Tablet 21/07/2020 conducted on Form 5D along
Plot No.224, Contains: Rs. 50,000/- 10-04-18, and with the
Sector 23, Favipiravir dated 21-07- the report submission of
Korangi …200mg 2020 concludes Differential fee of
Industrial (#1992348) acceptable level Rs. 30,000/-
Area, Karachi Form 5D of compliance
1022. M/s Ambrosia Fabiflu Each Film Dy.No. As per Inspection date Deferred for
Pharmaceutic 200mg Coated 17713 dated SRO 08/10/2018, the submission of
als. Tablet Tablet 21/07/2020 firm was found Form 5D along
Plot # 18, Contains: Rs. 20,000/- working in with the
Street # 09, Favipiravir dated 21-07- compliance to submission of
National …200mg 2020 GMP. Differential fee of
Industrial (#2048923) (Differential fee Rs. 30,000/-
Zone, Rawat, Form 5 of Rs. 30,000/-
Pakistan is required to be
submitted)
1023. M/s Amson Ampirav Each Film Dy.No. As per Inspection date Deferred for
Vaccines & ir 200mg Coated 17448 dated SRO 04/02/2020, the submission of
Pharma Pvt Tablet Tablet 17/07/2020 panel Form 5D along
Ltd Contains: Rs. 20,000/- recommended with the
110-111. 152- Favipiravir dated 17-07- renewal of submission of
156, … 2020 DML. Differential fee of
Industrial 200mg (#2017953) (Differential fee Rs. 30,000/-
Triangle, Form 5 of Rs. 30,000/-
Kahuta Road, is required to be
Islamabad submitted)
1024. M/s S.J & G Favipir Each Film Dy.No. 10’s Last inspection Approved with
Fazul Ellahie 200mg Coated 17447 dated As per report dated innovator’s
Pvt Ltd. Tablet Tablet 17/07/2020 SRO 02/05/18 specification.
E-46, S.I.T.E. Contains: Rs. 50,000/- concluding as
Karachi- Favipiravir dated 16-07- under:
75700 …200mg 2020 ―The firm has
(#2025382) complied/impro
Form 5D ved according to
the directions of
the FID. Panel
was satisfied for
the
improvements
under taken by
the firm
1025. M/s Favisir Each Film Dy.No. 10’s. Dated; 08-07- Approved with
Pharmasol 200mg Coated 17446 dated 30’s 2019 & 25-07- innovator’s
(Pvt) Ltd. Tablet Tablet 17/07/2020 As per 2019 specification.
Plot No. 549, Contains: Rs. 50,000/- SRO satisfactory
Sundar Favipiravir dated 14-07- level of GMP
Industrial … 2020 compliance
Estate, 200mg (#1952628)
Raiwind Form 5D
Road, Lahore

1026. M/s Favi Each Film Dy.No. As per GMP certificate Deferred for
Paramount 200mg Coated 17573 dated SRO issued on submission of
Pharmaceutic Tablet Tablet 20/07/2020 28/02/2019. Form 5D along
alPlot No. 36, Contains: Rs. 20,000/- (Differential fee with the
Industrial Favipiravir dated 20-07- of Rs. 30,000/- submission of
Triangle, …200mg 2020 is required to be Differential fee of
Kahuta Road, (#20381510) submitted) Rs. 30,000/-
Islamabad Form 5
1027. M/s Medisave Covir Each Film Dy.No. As per Inspection date Deferred for
Pharmaceutic 200mg Coated 17872 dated SRO 11-12-2017 & submission of
als. Tablet Tablet 22/07/2020 10-01-2018. Form 5D along
Plot 578-579, Contains: Rs. 20,000/- GMP Certificate with the
Sundar Favipiravir dated 22-07- issued on 15-03- submission of
Industrial … 2020 2018 Differential fee of
Estate, 200mg (1995057) Rs. 30,000/-
Lahore, Differential
Pakistan fee of Rs.
30,000/-
(#1995060)
dated 25 Aug
2020
Form 5D
1028. M/s Medipir Each Film Dy.No. 10’s. The firm has Deferred for
Mediceena a 200mg Coated 17873 dated 20’s, submitted copy submission of
Pharma. Tablet Tablet 22/07/2020 100’s, of GMP Form 5D along
27 Km, Contains: Rs. 20,000/- 500’s certificate based with the
Raiwind Favipiravir dated 21-07- As per on inspection submission of
Road, Lahore, …200mg 2020 SRO conducted on Differential fee of
Pakistan (#2045870) 24-9-2019. Rs. 30,000/-
30,000/- Need to submit
(# 2046905) form 5D
dated 8-09-
2020
Form 5
1029. M/s Martin Frovir Each Film Dy.No. As per Last inspection Approved with
Dow Limited. 200mg Coated 18211 dated SRO report dated 29- innovator’s
Plot No. 37, Tablet Tablet 24/07/2020 01-2018, GMP specification.
Sector 19, Contains: Rs. 50,000/- are rated as
Korangi Favipiravir dated 24-07- Good.
Industrial …200mg 2020
Area, Karachi (2029927)
Form 5D
1030. M/s Liven Favi- Each Film Dy.No. 10’s. GMP Approved with
Pharmaceutic Tab Coated 18213 dated 30’s certificate innovator’s
als Pvt Ltd. 200mg Tablet 24/07/2020 As per issued on specification.
49 km, Tablet Contains: Rs. 50,000/- SRO 31/07/2019 on
Lahore Favipiravir dated 24-07- the basis of
Multan Road. …200mg 2020 inspection
(#2037403) conducted on
Form 5D 03/07/2019.

1031. M/s Titlis Favir Each Film Dy.No. 14’s. GMP certificate Approved with
Pharma. 200mg Coated 18069 dated 28’s issued on innovator’s
528-A, Tablet Tablet 23/07/2020 As per 27/07/2018 on specification.
Sundar Contains: Rs. 50,000/- SRO the basis of
Industrial Favipiravir dated 23-07- inspection
Estate, …200mg 2020 conducted on
Raiwind (#2043886) 11/07/2018.
Road, Lahore Form 5D
1032. M/s CKD Favip Each Film Dy.No. As per Last GMP Approved with
Pharmaceutic 200mg Coated 18069 dated SRO inspection was innovator’s
als Pakistan Tablet Tablet 23/07/2020 conducted on specification.
Private Contains: Rs. 50,000/- 04-09-2018 and
Limited. Favipiravir dated 23-07- the report
Plot No. … 2020 concludes good
50/28, 200mg (#1997141) compliance of
Korangi Form 5D the firm.
Industrial
Area, Karachi
1033. M/s Rogen Favigen Each Film Dy.No. 10’s. Inspection date Deferred for
Pharmaceutic 200mg Coated 18378 dated 20’s, 25/01/2019, The submission of
als. Tablet Tablet 27/07/2020 30’s, firm is operating Form 5D along
Plot No. 30, Contains: Rs. 20,000/- 50’s, in compliance with the
Street # S-4, Favipiravir dated 27-07- 100’s with GMP. submission of
National …200mg 2020 As per (Differential fee Differential fee of
Industrial (2038163) SRO of Rs. 30,000/- Rs. 30,000/-
Zone, Rawat, Form 5 is required to be
Islamabad submitted)
1034. M/s Sigma Favir Each Film Dy.No. 14’s. Certificate of Approved with
pharma 200mg coated 18536 dated 28’s GMP Issued on innovator’s
International Tablet Tablet 28/07/2020 As per 19-10-2019 specification.
Pvt Ltd. Contains: Rs. 50,000/- SRO
Plot # E-50, Favipiravir dated 28-07-
North …200mg 2020
Western (#1928839)
Industrial Form 5D
Zone, Bin
Qasim,
Karachi,
Pakistan
1035. M/s Islam Favipin Each Film Dy.No. 14’s. New License Deferred for
Pharmaceutic 200mg Coated 18535 dated 28’s (letter issuance submission of
als. Tablet Tablet 28/07/2020 As per date: 29th Form 5D along
7 km, Pasrur Contains: Rs. 20,000/- SRO August 2018) with the
Road, Sialkot Favipiravir dated 28-07- GMP status can submission of
…200mg 2020 only be Differential fee of
(2039205) ascertained upon Rs. 30,000/-
Form 5 the start of
active
production,
however:
Keeping in view
the facility
inspected the
firm has
requisite for
manufacturing
of
pharmaceuticals.
(Differential fee
of Rs. 30,000/-
is required to be
submitted)
1036. M/s Noa Favigan Each Film Dy.No. As per Panel inspection Approved with
Hemis 200mg Coated 18537 dated SRO dated 28-02- innovator’s
Pharmaceutic Tablet Tablet 28/07/2020 2019 specification.
als. Contains: Rs. 50,000/- recommended
Plot No. 154, Favipiravir dated 28-07- renewal of
Sector-23, … 2020 DML.
Korangi 200mg (#0040535)
Industrial Form 5D
Area, Karachi
1037. M/s Curavir Each Film Dy.No. As per GMP inspection Approved with
Cunningham 200mg Coated 18694 dated SRO dated 31-01- innovator’s
Pharmaceutic Tablet Tablet 29/07/2020 2018, firm was specification.
als Pvt Ltd. Contains: Rs. 50,000/- operating under
Plot # 81, Favipiravir dated 29-07- good
Sunder …200mg 2020 compliance of
Industrial (#2036769) cGMP on the
Estate, Form 5D day of
Raiwind Road inspection.
Lahore,
Pakistan
1038. M/s Favir Each Film Dy.No. 7’s. Last inspection Approved with
Pharmatec 200mg Coated 18691 dated 10’s. report dated 30- innovator’s
Pakistan Pvt Tablet Tablet 29/07/2020 14’s. 04-18 with the specification.
Ltd. Contains: Rs. 50,000/- 20’s, remarks level of
D-86/A, Favipiravir dated 29-07- 30’s. gmp is rated as
S.I.T.E. …200mg 2020 As per good.
Karachi- (#1909746) SRO “GMP
75700 Form 5D Certificate
issued on 15-12-
2017”
1039. M/s Curatech Fluvid Each Film Dy.No. As per The panel Deferred for
Pharma Pvt 200mg Coated 18689 dated SRO recommended submission of
Ltd. Tablet Tablet 29/07/2020 renewal of Form 5D along
35-Km, Contains: Rs. 20,000/- DML, with the
Multan Road, Favipiravir dated 29-07- inspection date submission of
Lahore … 2020 16/03/2018. Differential fee of
200mg (#0744236) (Differential fee Rs. 30,000/-
Form 5D of Rs. 30,000/-
is required to be
submitted)

1040. M/s Brookes Infuvir Each Film Dy.No. 10’s. Last inspection Approved with
Pharma Pvt 200mg Coated 18692 dated 20’s, was conducted innovator’s
Ltd. Tablet Tablet 29/07/2020 30’s, on 15-07-2019 specification.
58 & 59, Contains: Rs. 20,000/- 40’s with the
Sector 15, Favipiravir dated 29-07- As per following
Korangi … 2020 SRO remarks:
Industrial 200mg (#1908234) Based on the
Area, Karachi 30,000/- above
Dated 28 observations the
Aug 2020 panel
(#1908245) unanimously
Form 5D recommends the
firm for the
grant of GMP
Certificate for
export purpose.
1041. M/s Inventor Favinor Each Film Dy.No. 10’s. The firm was Deferred for
Pharma. 200mg Coated 18761 dated 20’s, inspected on 05- submission of
Plot No. Tablet Tablet 30/07/2020 30’s, 07-2018 and Form 5D along
K/196, Contains: Rs. 50,000/- 40’s conclusion was with the
S.I.T.E. Favipiravir dated 29-07- As per their current submission of
(SHW) Phase …200mg 2020 SRO GMP is rated as Differential fee of
II, Karachi (#1996267) GOOD. Rs. 30,000/-
Form 5D
1042. M/s Pharmix Avipar Each Film Dy.No. 10’s. The firm was Deferred for
Laboratories 200mg Coated 18768 dated 20’s, inspected on submission of
Pvt Ltd. Tablet Tablet 30/07/2020 30’s, 13.09.2019 the Form 5D along
21 Km, Contains: Rs. 20,000/- 40’s following with the
Ferozepur Favipiravir dated 30-07- 50’s recommendation submission of
Road, Lahore …200mg 2020 As per s: Differential fee of
(#2016692) SRO The panel of Rs. 30,000/-
Form 5 inspector
recommends the
renewal of DML
No. 000397
subject to
verification of
all approved
sections by the
licensing
division, DRAP,
Islamabad.
(Differential fee
of Rs. 30,000/-
is required to be
submitted)
1043. M/s BJ BJ-Gan Each Film Dy.No. As per Inspection date Deferred for
Pharmaceutic 200mg Coated 18769 dated SRO 15/01/2020. submission of
als. Tablet Tablet 30/07/2020 Overall Form 5D along
18 Km, Contains: Rs. 20,000/- satisfactory at with the
Mandialli Favipiravir dated 30-07- the time of submission of
Stop, Lahore- … 2020 inspection. Differential fee of
Sheikhupura 200mg (#1999961) (Differential fee Rs. 30,000/-
Road, Lahore Form 5 of Rs. 30,000/-
is required to be
submitted)

1044. M/s Lisko Ferrari Each Film Dy.No. As per The firm was Deferred for
Pakistan Pvt tablet Coated 18777 dated SRO inspected on submission of
Ltd. 200mg Tablet 30/07/2020 24.04.2018, Form 5D along
L-10-D, Contains: Rs. 20,000/- conclusion of with the
Block 21, Favipiravir dated 30-07- inspection was: submission of
Shaheed … 2020 “Based on Differential fee of
Rashid 200mg (#1908530) current Rs. 30,000/-
Minhas Road, Form 5 inspection,
F.B. documents
Industrial reviewed it was
Area, Karachi noted that firm
is currently
working under
satisfactory
level of cGMP
compliance.
(Show cause
notice revoked
on 27-04-2018)”
(Differential fee
of Rs. 30,000/-
is required to be
submitted)
1045. M/s Wilson's Fav-600 Each Film Dy.No. As per Evidence of Deferred for
Pharmaceutic Tablet Coated 15861 dated SRO RRA and Me submission of
als. Tablet 03/07/2020 too Form 5D along
387-388, I-9, Contains: Rs. 50,000/- with the
Industrial Favipiravir
dated 02-07- submission of
Area, …600mg 2020 Differential fee of
Islamabad (#2029295) Rs. 30,000/-
Form 5D
1046. M/s Indus Indopavi Each Film Dy.No. As per Last inspection Approved with
Pharma (Pvt.) r 200mg Coated 15447 dated SRO report 16-8- innovator’s
Ltd. Tablet Tablet 30/06/2020 2017 firm was specification.
Plot No. Contains: Rs. 50,000/- considered to be
26,27 & 63- Favipiravir (#2026671) operating at an
67, Sector 27, …200mg dated 30-06- acceptable level
Korangi 2020 Form of compliance
Industrial 5D with GMP.
Area, Karachi
1047. M/s Fynk Fabiflu Each Film Dy.No. As per Last inspection Approved with
Pharmaceutic 200mg Coated 15443 dated SRO report dated innovator’s
als. Tablet Tablet 30/06/2020 21/11/2017, fair specification.
19km G.T. Contains: Rs. 20,000/- level of GMP
Road Favipiravir (#2038125) compliance.
Kalashah … dated 30-06-
Kaku, Lahore, 200mg 2020 Form
Pakistan 5D
1048. M/s Himmel Favipira Each Tablet Dy.No. As per COPP: Approved with
Pharmaceutic 200mg Contains: 13767 dated SRO (Original) innovator’s
als (Pvt) Ltd. Tablet Favipiravir 16/06/2020 embassy attested specification as per
793-D Block … Rs. 50,000/- Issued by: Gov Import Policy for
C, Faisal 200mg dated 16-06- of the “People's Finished Drugs.
Town, 2020 Republic of
Lahore, (#2043426) Bangladesh”
Pakistan Form 5A COPP
By Certificate #:

M/s Beacon DA/6-
Pharmaceutic 110/2016/2802
als Limited. Dated: 05-05-
Kathali, 2020
Bhaluka, GMP in COPP:
Mymensingh, inspected
Bangladesh DSL: provided
Stability: data of
3 batches on
zone 4 A was
submitted
Sole agency
agreement
provided
1049. M/s Pinnacle Favicovi Each Film Dy.No. 40’s COPP: (Not Decision: Deferred
Biotech Pvt r 200mg Coated 18538 dated As per attached) for the following:
Ltd. Tablet Tablet 28/07/2020 SRO Issued by:  Submission
FD-49-50-51- Contains: Rs. 100,000/- turkey of stability
54-A8, Favipiravir dated 28-07- Stability not studies of all the
Korangi … 2020 attached pack sizes
Creek 200mg (#0566476) No sole agency applied.
Industrial Form 5A agreement  Submission
Park, of sole agency
Karachi- agreement
75190,  Submission
Pakistan of original,
By legalized and
M/s Atabay valid COPP
Ilac Fabrikasi mentoning the
A.S. expiry date.
Acibadem  And
Koftuncu further
Sok.No13471 delibration
8 Kadikoy, regarding
Istanbul approval of an
imported
product.
Following applications has been received on Form-5/Form 5-D instead of Form 5-F as per details mentioned
against each.
S. No. Name of applicant Brand Name composition Diary no. Date /Fee &
Date/ form
1050. M/s English EAC Each Tablet Contains: Dy.No. 15568 dated
Pharmaceuticals 1g/327mg/4mg5 Calcium Lactate 01/07/2020 Rs. 20,000/-
Industries. 00mg/10mg Gluconate…1g dated 04-06-2020 Form 5
Link Kattar Bund Road, Tablet Calcium
Thokar Niaz Baig, Carbonate…34mg
Multan Road, Lahore Vitamin D…34mg
Vitamin C…500mg
Vitamin B6…100mg

1051. M/s English ACC Chewable Each Tablet Contains: Dy.No. 15569 dated
Pharmaceuticals Tablet Calcium Lactate 01/07/2020 Rs. 20,000/-
Industries. Gluconate…1g dated 04-06-2020 Form 5
Link Kattar Bund Road, Calcium
Thokar Niaz Baig, Carbonate…34mg
Multan Road, Lahore Vitamin D3…4mg
Vitamin C…50mg
Vitamin B6…10mg
1052. M/s Vision Meprox Plus Each Film Coated Dy.No. 15167 dated
Pharmaceuticals. 250/100 mg Tablet Contains: 29/06/2020 Rs. 20,000/-
Plot # 22,23, Industrial Tablet Atovaquone…250mg dated 29-06-2020 Form 5
Triangle, Kahuta Road, Proguanil Hcl…100mg
Islamabad
1053. M/s Welwink Ivermik 3mg Each Uncoated Tablet Dy.No. 14748 dated
Pharmaceuticals. Tablet Contains: 24/06/2020 Rs. 20,000/-
Factory G.T. Road, Ivermectin…3mg dated 22-06-2020 Form 5
Industrial Estate,
Gujranwala Cantt.
1054. M/s Welwink Ivermik 6mg Each Uncoated Tablet Dy.No. 14746 dated
Pharmaceuticals. Tablet Contains: 24/06/2020 Rs. 20,000/-
Factory G.T. Road, Ivermectin…6mg dated 22-06-2020 Form 5
Industrial Estate,
Gujranwala Cantt.
1055. M/s Radiant Pharma Pvt Merotin 3mg Each Tablet Contains: Dy.No. 14518 dated
Ltd.43-E, Sundar Tablet Ivermectin…3mg 23/06/2020 Rs. 20,000/-
Industrial Estate, Lahore dated 23-06-2020 Form 5
1056. M/s Saffron IverSaf 12mg Each Tablet Contains: Dy.No. 14359 dated
Pharmaceuticals (Pvt) Tablet Ivermectin…12mg 22/06/2020 Rs. 20,000/-
Ltd. 19 Km Sheikhupura dated 22-06-2020 Form 5
Road, Faislabad
Road, Faislabad
Road, Faislabad
1059. M/s Bio Labs Pvt Ltd. Covectin 3mg Each Tablet Contains: Dy.No. 14227 dated
Plot # 145, Industrial Tablet Ivermectin…3mg 19/06/2020 Rs. 20,000/-
Triangle, Kahuta Road, dated 17-06-2020 Form 5
Islamabad
1060. M/s Medisure Revexs 3mg Each Tablet Contains: Dy.No. 13773 dated
Laboratories Pakistan Pvt Tablet Ivermectin…3mg 16/06/2020 Rs. 20,000/-
Ltd. A-115, S.I.T.E, dated 16-06-2020 Form 5
Super Highway, Karachi,
Pakistan
1061. M/s Medisure Revexs 6mg Each Tablet Contains: Dy.No. 13772 dated
Laboratories Pakistan Pvt Tablet Ivermectin…6mg 16/06/2020 Rs. 20,000/-
Ltd. A-115, S.I.T.E, dated 16-06-2020 Form 5
Super Highway, Karachi,
Pakistan

1062. M/s Neutro Pharma (Pvt) Ivermec 3mg Each Tablet Contains: Dy.No. 14522 dated
Ltd. 9.5 km, Sheikhupura Tablet Ivermectin…3mg 23/06/2020 Rs. 20,000/-
Road,Lahore dated 23-06-2020 Form 5
Ltd. 9.5 km, Sheikhupura Tablet Ivermectin…12mg 23/06/2020 Rs. 20,000/-
Road,Lahore dated 23-06-2020 Form 5
Ltd. Tablet Ivermectin…6mg 23/06/2020 Rs. 20,000/-
9.5 km, Sheikhupura dated 23-06-2020 Form 5
Road,Lahore
1065. M/s Shaigan Ivertin 6mg Each Tablet Contains: Dy.No. 14524 dated
Ltd, 14 KM Adyala Raod dated 22-06-2020 Form 5
Post Office Daghal,
Rawalpindi
1066. M/s Shaigan Ivertin 3mg Each Tablet Contains: Dy.No. 14523 dated
Ltd, 14 KM Adyala Raod dated 22-06-2020 Form 5
Post Office Daghal,
Rawalpindi
1067. M/s Bio Labs Pvt Ltd. Covectin 6mg Each Tablet Contains: Dy.No. 14228 dated
Plot # 145, Industrial Tablet Ivermectin…6mg 17/06/2020 Rs. 20,000/-
Triangle, Kahuta Road, dated 19-06-2020 Form 5
Islamabad
1068. M/s High-Q Ectime 6mg Each Tablet Contains: Dy.No. 14292 dated
Pharmaceuticals. Plot Tablet Ivermectin…6mg 22/06/2020 Rs. 20,000/-
No.224, Sector 23, dated 22-06-2020 Form 5
Korangi Industrial Area,
Karachi
1069. M/s High-Q Ectime 3mg Each Tablet Contains: Dy.No. 14291 dated
Pharmaceuticals. Plot Tablet Ivermectin…3mg 22/06/2020 Rs. 20,000/-
No.224, Sector 23, dated 22-06-2020 Form 5
Korangi Industrial Area,
Karachi
1070. M/s Zafa Covimac 6mg Each Tablet Contains: Dy.No. 17710 dated
Pharmaceuticals Tablet Ivernectin…6mg 21/07/2020 Rs. 20,000/-
Laboratories Private dated 20-07-2020 Form 5
Limited. L-1/B, Block-
22, Federal B industrial
Area, Karachi
1071. M/s Global Dexasone 2mg Each Tablet Contains: Dy.No. 14290 dated
Pharmaceuticals Pvt Ltd Tablet Dexamethasone…2mg 22/06/2020 Rs. 20,000/-
Plot # 204-205, Industrial dated 22-06-2020 Form 5
Triangle, Kahuta Road,
Islamabad
1072. M/s The Schazoo Dexco Injection Each ml Contains: Dy.No. 16002 dated
Pharmaceutical Dexamethasone 06/07/2020 Rs. 20,000/-
Laboratories Pvt Ltd. Phosphate Eq. to dated 26-06-2020 Form 5
Kalalwala Stop, 20 km Dexamethasone
Lahore-Jaranwala Road, Sodium Phosphate
Distt Sheikhupura, 4.4mg…4mg
Pakistan

1073. M/s The Schazoo Dexco 0.5mg Each Tablet Contains: Dy.No. 16001 dated
Pharmaceutical Tablet Dexamethasone…0.5m 06/07/2020 Rs. 20,000/-
Laboratories Pvt Ltd. g dated 26-06-2020 Form 5
Kalalwala Stop, 20 km
Lahore-Jaranwala Road,
Distt Sheikhupura,
Pakistan
Decision: Registration Board deferred above cases and directed the firms to apply on Form-5F.
Item No. 2: Agenda of Evaluator PEC-VII

a. New cases
1074. 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:
Diary No. Date of R& I & fee Form-5 Dy. No 16521 dated 07-03-2019 Rs.20,000/- Dated
07-03-2019 (#1900766)
Form Form-5
Pack size & Demanded Price 2 ml glass ampoule
As per SRO
Approval status of product in THIOCOLCHICOSIDE PHARMY II 4 mg/2 ml, solution
Reference Regulatory Authorities injectable ampule. ANSM approved
Me-too status Myolax Injection. Reg. No. Reg. No. 69277
GMP status DML issued on 5th March, 2019.
Remarks of Evaluator VII

Decision: Deferred for consideration on its turn

Pakistan
Brand Name +Dosage Form + Strength Athancinol Injection
Composition Each 4ml Injection Contains:
Phloroglucinol Hydrated…40mg
Trimethylphloroglucinol….0.04mg
Diary No. Date of R& I & fee Form-5 Dy.No 14904 dated 07-03-2019 Rs.20,000/- Dated 07-
03-2019 (#1902260)
Form Form-5
Approval status of product in Spasfon injection by M/s Teva Health (ANSM) France
Reference Regulatory Authorities 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
Pakistan
Brand Name +Dosage Form + Strength Suxamethonium 50mg Injection
Composition Each ml Injection Contains:
Suxamethonium chloride …50mg (IV/IM)
06-03-2019 (#1900797)
Form Form-5
Pack size & Demanded Price 2 ml ampoule
As per SRO
Approval status of product in Suxamethonium chloride 100 mg/2 ml injection 2m1, clear
Reference Regulatory Authorities glass ampoules, glass type I (MHRA approved)
Me-too status Suxal Injection 100mg/ 2ml of M/s Global Pharma (Reg. #
026629)

Pakistan
Brand Name +Dosage Form + Strength Transalta 250mg/5ml Injection
Composition Each 5ml Injection Contains:
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


Pakistan
Brand Name +Dosage Form + Strength Moxid 400mg Tablets
th
03-2019 (#1902267)
Form Form-5
Pack size & Demanded Price 1x5’s As per SRO
Approval status of product in AVELOX (moxifloxacin as hydrochloride) 400mg tablets,
Reference Regulatory Authorities film-coated. USFDA approved
Me-too status G-Mox 400 mg Tablets by M/s Reliance Pharma, Reg. No.
72148

Pakistan
Brand Name +Dosage Form + Strength Spas 40mg Tablets
Otilonium Bromide…40mg
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.

Pakistan
Brand Name +Dosage Form + Strength Levo 250mg Tablets
Levofloxacin as hemihydrate…250mg
03-2019 (#1900773)
Pharmacological Group Fluoroquinolones, Antibiotic
Form Form-5
Approval status of product in Levofloxacin Tablets 250mg By Actavis Group United
Reference Regulatory Authorities Kingdom (MHRA)
Me-too status Leflox Tablets 250mg By Getz


Pakistan
Brand Name +Dosage Form + Strength Tazo 2mg Tablets
Tizanidine HCL Eq. to…2mg
03-2019 (#1902355)
Pharmacological Group Muscle relaxant
Form Form-5
Approval status of product in Tizanidine 2mg Tablets by M/s Actavis UK Ltd (MHRA)
Me-too status Musidin 2mg Tablet by M/s Martin Dow (Reg# 027218)
VII
Remarks of Evaluator

Pakistan
Brand Name +Dosage Form + Strength Tazo 4mg Tablets
Tizanidine HCL Eq. to…4mg
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 Ltd (MHRA)
Me-too status Musidin 4mg Tablet by M/s Martin Dow (Reg#037105)
VII
Pakistan
Brand Name +Dosage Form + Strength Aultaroxit CR 12.5mg Tablet
Paroxetine Hcl Eq. to Paroxetine…12.5mg
03-2019 (#1902356)
Pharmacological Group SSRI
Form Form-5

Approval status of product in Paxil CR 12.5mg Tablet by M/s Apotex Technologies,
Reference Regulatory Authorities USA.
Me-too status Paroxin CR 12.5mg Tablet by M/s Sharooq
Pharmaceuticals
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

Pakistan
Brand Name +Dosage Form + Strength Diclo K 50mg Tablets
Diclofenac potassium…50mg
03-2019 (#1900798)
Form Form-5
Approval status of product in Diclofenac Potassium 50mg Film Coated Tablets by M/s
Reference Regulatory Authorities Accord Healthcare Limited, MHRA
Me-too status NOREX TABLETS 50mg tablets by M/s Alen
Pharmaceuticals (Pvt) Ltd, Reg. No. 3172

Pakistan
Brand Name +Dosage Form + Strength Letro 2.5mg Tablets
Letrozole…2.5mg
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 Novartis
Reference Regulatory Authorities Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too status Femara 2.5mg Tablet by Novartis (Reg. No. 021129)

Pakistan
Brand Name +Dosage Form + Strength Piroxiwen 20mg Tablets
Piroxicam Betacyclodextrin…20mg
Diary No. Date of R& I & fee Form-5 Dy. No 16520 dated 07-03-2019 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 (ANSM approved)
Me-too status Piroxibet 20mg Tablets of M/s Lawari
International (Reg. # 054939)
VII
Pakistan
Brand Name +Dosage Form + Strength Soda 200mg Tablets
Sodium Valproate…200mg
03-2019 (#1900763)
Form Form-5
Pack size & Demanded Price 10x10’s
As per SRO
Approval status of product in Epilim 200 Gastro-resistant tablets (MHRA)
Me-too status Epilim E.C 200mg Tablet by Sanofi (#058501)
from
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
Pakistan
Quetiapine as Fumarate…150mg
03-2019 (#1900760)

Form Form-5
Approval status of product in SEROQUEL® (quetiapine fumarate). USFDA approved
Me-too status Ziapine XR150mg Oral Tablets Reg. No. 78755
Pakistan
Brand Name +Dosage Form + Strength Pentrex 40mg Tablets
Composition Each gastro resistant Tablet Contains:
Pantoprazole as Sodium Sesquihydrate…40mg
03-2019 (#1902357)
Form Form-5
Approval status of product in Pantoprazole 40 mg gastro resistant Tablet (MHRA Approved)
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.
Pakistan
Brand Name +Dosage Form + Strength Leflunomalt 20mg Tablets
Leflunomide…20mg
03-2019 (#1900799)
Pharmacological Group Immunosuppressant
Form Form-5
Approval status of product in ARAVA 20 mg film-coated tablet by Sanofi (ANSM approved)
Me-too status Lefluno Tablet of M/s Caraway Pharma 050063
Pakistan

Brand Name +Dosage Form + Strength Cipro 500mg Tablets
Ciprofloxacin HCL Eq. to Ciprofloxacin…500mg
06-03-2019 (#1900787)
Form Form-5
As per SRO
Approval status of product in Ciprofloxacin tablets 500mg of M/s Special Concept
Reference Regulatory Authorities Development (UK MHRA Approved)
Me-too status Axcin Tablets 500mg of M/s Novartis Pharmaceuticals

Pakistan
Brand Name +Dosage Form + Strength Artho 75/200 mg Tablets
Misoprostol…200mg
03-2019 (#1902366)
Form Form-5
Approval status of product in Arthrotec 75 modified-release tablets by M/s Pfizer, MHRA
Me-too status Arsofin Tablets by M/s Martin Dow Pharmaceuticals (Pakistan)
Ltd, Reg. no. 48013
Remarks of Evaluator VII Firm innitialy apllied 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.

Pakistan
Brand Name +Dosage Form + Strength Ceflar 250mg Tablets
Clarithromycin…250mg
03-2019 (#1902266)
Pharmacological Group Macrolide
Form Form-5
Approval status of product in Clarithromycin 250 mg of Sandoz (USFDA Approved)
Me-too status Clarmark 250mg tablet Of M/S Wel Mark Pharmaceutical
VII
Pakistan
Brand Name +Dosage Form + Strength Aultopride 50mg Tablets
Itopride HCL…50mg
03-201 (#1902255)
Pharmacological Group Prokinatic
Form Form-5
Approval status of product in Ganaton 50mg Tablet by Abbott (PMDA approved)
Me-too status Itoguard Tablet of M/s Macter International Karachi
(Reg.#055753)
from Itopride to Itopride HCL which is according to the
17/8/2020
Pakistan
Brand Name +Dosage Form + Strength Cipro 250mg Tablets
Ciprofloxacin HCL Eq. to Ciprofloxacin…250mg
03-2019 (#1902384)
Form Form-5

Approval status of product in Ciprofloxacin tablets 250mg of M/s Special Concept
Reference Regulatory Authorities Development (UK MHRA Approved)
Me-too status Axcin Tablets 250mg of M/s Novartis Pharmaceuticals
Pakistan
Brand Name +Dosage Form + Strength Levo 500mg Tablets
Levofloxacin as hemihydrate…500mg
03-2019 (#1902382)
Form Form-5
Approval status of product in Levofloxacin Tablets 500mg of M/s Actavis Group United
Reference Regulatory Authorities Kingdom (MHRA Approved)
Me-too status Leflox Tablets 500mg of M/s Getz Pharma
Pakistan
Brand Name +Dosage Form + Strength Stowel 10mg Tablets
Escitalopram as Oxalate…10mg
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 by MHRA of UK
Me-too status Zavesca tablet 10mg of Getz Pharma. (Reg.#045279)
Pakistan
Brand Name +Dosage Form + Strength Dimecrotic Acid 50mg Tablets
Dimecrotic Acid…50mg
03-2019 (#1900788)
Pharmacological Group Gastrointestinal drugs
Cholagogues & hepatic preparations

Form Form-5
As per SRO
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
1099. 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
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 barand name to “Jovecare tablets”
Rawalpindi
Brand Name +Dosage Form + Strength Afexdine 120mg Tablet
Fexofenadine Hcl…120mg
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)
Rawalpindi
Brand Name +Dosage Form + Strength Andreprol 100mg Tablet
03-2019 (#0845207)
Form Form-5
Approval status of product in Metoprolol Tartrate 100 mg Film-coated Tablets. MHRA
Me-too status Dronic 100mg Tablets, film coated. Reg. No. 81425
Rawalpindi
Brand Name +Dosage Form + Strength Alpharich 0.5mcg Tablet
Alfacalcidol…0.5mcg
03-2019 (#0588348)
Form Form-5
Approval status of product in Alfacalcidol tablet 0.25mcg PMDA Japan approved
Me-too status Alfasta Tablet 0.25mcg by M/s Star Labs, Reg. No. 81398
Rawalpindi
Brand Name +Dosage Form + Strength Arremide 50mg Tablet
Lacosamide…50 mg
03-2019 (#0588341)
Pharmacological Group Antiepilaptic
Form Form-5
Approval status of product in VIMPAT® (lacosamide) Tablet, Film Coated
Reference Regulatory Authorities USFDA Approved.
Me-too status Atcomid 50mg Tablet
Atco Lab. Karachi. (Reg. # 075947)
Rawalpindi
Lacosamide…100mg
03-2019 (#0588340)
Form Form-5
Approval status of product in Vimpat tablet of UCB Inc, USFDA Approved.
Me-too status Lacolep tablet of Hilton Pharma (Reg. No#
073858).
Rawalpindi
Lacosamide…150mg
03-2019 (#0588342)
Pharmacological Group antiepileptic
Form Form-5
Approval status of product in VIMPAT® (lacosamide) Tablet, Film Coated
Me-too status Atcomid 150mg Tablet
Atco Lab. Karachi. (Reg.#075949)
Rawalpindi
Brand Name +Dosage Form + Strength Thioside 4mg Capsule
03-2 (#0846646)
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)
Rawalpindi
03-2019 (#0588349)
Pharmacological Group Other antihistamines for systemic use
Form Form-5
Approval status of product in FEXOTABS fexofenadine hydrochloride 60mg tablet blister
Reference Regulatory Authorities pack.TGA approved
Me-too status Vigil Tablets by Tabros Pharma. (Reg. No. 39776)
1108. Duplicate with serial no. 1109.
Rawalpindi
Brand Name +Dosage Form + Strength Andreprol 50mg Tablet
03-2019 (#1902392)
Form Form-5

Approval status of product in Metoprolol Tartrate 50 mg Film-coated Tablets. MHRA
Me-too status Mepresor 50mg Tablets, film-coated. Reg. No. 36124
Rawalpindi
03-2019 (#1900442)
Pharmacological Group H1 receptor antagonist
Form Form-5
Approval status of product in Fexofenadine hydrochloride film coated tablet 180mg by M/s
Reference Regulatory Authorities Cipla (MHRA Approved)
Me-too status Epodin 180mg Tablet by M/s Epoch Pharmaceutical, Reg. No.
58058
Rawalpindi
Brand Name +Dosage Form + Strength Misonac Tablet
Paracetamol…500mg
Caffeine…65mg
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 Coated Tablets by
Reference Regulatory Authorities 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)
Rawalpindi
Brand Name +Dosage Form + Strength Siliptin-M 50/500 mg Tablet
Sitagliptin as Sitagliptin Phosphate Monohydrate…50mg
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
Rawalpindi
Brand Name +Dosage Form + Strength Siliptin-M 50/1000 mg Tablet
Sitagliptin as Sitagliptin Phosphate Monohydrate…50mg
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
Rawalpindi
Brand Name +Dosage Form + Strength Utrobin 10mg Tablet
Solifenacin as Succinate…10mg
03-2019 (#1900446)
Pharmacological Group Muscarinic antagonist
Form Form-5
Approval status of product in Vesicare® (5mg& 10mg) film-coated tablet by M/s Astellas
Reference Regulatory Authorities Pharma Ltd, MHRA Approved.
Me-too status Solifen Tablet 10mg by M/s GetzPharma, Reg. No. 61203
Rawalpindi
Brand Name +Dosage Form + Strength Nebilol 5mg Tablet
Nebivolol as Hcl…5mg
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
Rawalpindi
Brand Name +Dosage Form + Strength Klomifen 50mg Tablet
Composition Each uncoated Tablet Contains:
Clomifene Citrate…50mg
03-2019 (#1900450)
Pharmacological Group Beta-1 receptor blocker
Form Form-5
Approval status of product in GENRX CLOMIPHENE clomifene citrate 50mg
Reference Regulatory Authorities Uncoated TGA Approved.
Me-too status Florid 50mg Tablet M/s Opal Labs, Karachi 075806
Rawalpindi
Brand Name +Dosage Form + Strength Arecrip 2.5mg Tablet
Bromocriptine as Mesylate…2.5mg
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 Pharma, MHRA
Me-too status Parlodel 2.5 mg tablet by M/s Novartis (Reg#004714)
Rawalpindi
Brand Name +Dosage Form + Strength Arrizin 4mg Tablet
Tizanidine as Hcl…4mg
03-2019 (#0846636)
Form Form-5
Pack size & Demanded Price 10’s as per SRO
Approval status of product in Zanaflex® (tizanidine hydrochloride) uncoated tablets,
Reference Regulatory Authorities USFDA Approved
Me-too status Tizax 4mg Tablet by Searle (#076022)
Remarks of Evaluator VII Initialy firm applied as Each Tablet Contains:
Tizanidine as Hcl…6mg but this strength is not available in RA
so firm revised its formulation and strength as Each Tablet
Contains:
Tizanidine as Hcl…4mg with fee of 20,000/- (#1983274) dated
26 aug 2020
Rawalpindi
Brand Name +Dosage Form + Strength Arractam 250 mg Tablet
03-2019 (#0588343)
Pharmacological Group Anti-Epileptic
Form Form-5

As per SRO
Approval status of product in Levetiracetam zentiva 250 mg of MHRA
Me-too status Levep 250mg Tablet by Hilton Pharma (Reg.
No. 053348
Rawalpindi
Brand Name +Dosage Form + Strength Arractam 750mg Tablet
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)
Rawalpindi
Brand Name +Dosage Form + Strength Arractam 1000mg Tablet
03-2019 (#0588346)
Form Form-5
As per SRO
Approval status of product in KEPPRA (250mg, 500mg, 750mg, 1000mg) film coated
Reference Regulatory Authorities tablets USFDA Approved
Me-too status Elicia 1000mg Tablet of Martin Dow
(Reg.#081157)

Rawalpindi
Brand Name +Dosage Form + Strength Utrobin 5mg Tablet
Solifenacin as Succinate…5 mg
07-03-2019 (#1900445)
Form Form-5
Approval status of product in Vesicare (5mg& 10mg) film-coated tablet by M/s Astellas
Me-too status Solifen Tablet 5mg by M/s GetzPharma, Reg. No. 61202
Rawalpindi
Brand Name +Dosage Form + Strength Misonac plus Tablet
Paracetamol…500mg
Caffeine…65mg
Chlorpheniramine (Maleate)…….2 mg
03-2019 (#1902392)
Pharmacological Group Analgesic and CNS Stimulent
Form Form-5
Approval status of product in Not found
Me-too status Hesmol Extra tablets of Wisdom Pharmaceuticals
Remarks of Evaluator VII Evidence in RRA
1124. 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
03-2019 (#0703856)
Pharmacological Group Aminoglycoside Antibacterial
Form Form-5
As per SRO

Approval status of product in Cidomycin 80mg/2ml Solution for Injection (5 x 2ml colourless
Reference Regulatory Authorities 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:
Decision: Approved.
Brand Name +Dosage Form + Strength Lexus 20 mg
Furosemide…20mg
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 Injection (MHRA
Reference Regulatory Authorities approved)
Me-too status Lasix Injection of Sanofi Aventis (Reg#000230)
Brand Name +Dosage Form + Strength Metolide 10mg/2ml Ampoule
Metoclopramide as Metoclopramide Hcl…10mg
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
Brand Name +Dosage Form + Strength Atropine 1mg/ml Injection
Atropine Sulphate…1mg
03-2019 (#0761616)
Pharmacological Group Anti- cholinergic
Form Form-5
Approval status of product in Atropine Sulfate Injection 1mg in 1 ml (MHRA)
Me-too status Atropine Injection By M/s. Alina: 049677
Brand Name +Dosage Form + Strength D-Spa 40mg/2ml Injection
Drotaverine Hcl…40mg
03-2019 (#0839015)
Form Form-5
Approval status of product in Approved in 3 European countries
Me-too status NO-SPA INJECTION. Reg No. 08296
Brand Name +Dosage Form + Strength Ketamile 500mg/10ml Ampoule
Ketamine as Ketamine Hcl…500mg
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 Vile

Brand Name +Dosage Form + Strength Avebion Ampoule
Thiamine Hcl…100mg
Pyridoxine Hcl…100mg
03-2019 (#0826520)
Pharmacological Group B-complex vitamin
Form Form-5
Approval status of product in Neurobion Injection by M/s Merck (Germany) Merck
Me-too status Neurobion Injection by Merck (Reg. No. 001485)
Decision: Deferred for consideration on its turn .
Brand Name +Dosage Form + Strength Gravisis 50mg/ml Injection
Dimenhydrinate …50mg
03-2019 (#0826524)
Pharmacological Group Antiemetic
Form Form-5
Approval status of product in Dimenhydrinate Injection of Fresenius Kabi, USFDA
Reference Regulatory Authorities Approved.
Me-too status Corinate 50mg/ml Inj. of Asian continental (Reg#057863).
Brand Name +Dosage Form + Strength Piromax 20mg/ml Injection
Piroxicam…20mg
03-2019 (#0761613)
Form Form-5
As per SRO

Approval status of product in Approved by ANSM of France
Me-too status Salden 20mg Injection of M/s Danas Pharma (Reg.#080373)
Pharmaceuticals by way of formulation for nine sections
Brand Name +Dosage Form + Strength Transit 500mg/5ml Injection
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 Injection by M/s Pfizer
Reference Regulatory Authorities Limited, MHRA
Me-too status Tremic -500 Injection of M/s M/s Fynk Pharmaceuticals,
Brand Name +Dosage Form + Strength Transit 250 mg/5ml Injection
03-2019 (#0826523)
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
Brand Name +Dosage Form + Strength Ketrolav 30mg/ml Ampoule
Ketrolac Trometamol…30mg
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)
Brand Name +Dosage Form + Strength Kinza 20mg/ml Ampoule
Nalbuphine Hcl…20mg
03-2019 (#0841037)
Pharmacological Group Potent analgesic.
Form Form-5
Approval status of product in NUBAIN – (nalbuphine hydrochloride) injection (1ml ampule),
Reference Regulatory Authorities for intramuscular, subcutaneous, or intravenous (USFDA).
Me-too status Nalfy Injection 20mg. Reg. No. 81911
Brand Name +Dosage Form + Strength D-Fenac 75mg/3ml Injection
03-2019 (#0826525)
Form Form-5
Approval status of product in NUBAIN – (nalbuphine hydrochloride) injection for
Reference Regulatory Authorities intramuscular, subcutaneous, or intravenous (USFDA).
Me-too status Nalfy Injection 20mg. Reg. No. 81911
Brand Name +Dosage Form + Strength Adrenaline 0.1% Injection
Composition Each Ampoule Contains:
Adrenaline…1mg
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)
Brand Name +Dosage Form + Strength Codomax 500/15 mg Tablet
Paracetamol…500mg
Codeine phosphate hemihydrate…15mg
03-2019 (#0841047)
Form Form-5
As per SRO
Approval status of product in Co-codamol 15/500 Tablets of Zentiva Pharma UK Limited
Me-too status Lowmol Tablets (Reg. 040426) of Lowit Pharma (Pvt) Ltd
Remarks of Evaluator VII In RRA Codeine phosphate hemihydrate not just codien No
master formulation and method of manufacturer
Brand Name +Dosage Form + Strength Montysis 4mg Sachet
Montelukast as Montelukast Sodium oral granules …4mg
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, USFDA
Me-too status Montiget Sachet of M/s Getz Pharma
(Reg.# 044046

Brand Name +Dosage Form + Strength Stilmix 10mg Tablet
Zolpidem Tartrate…10mg
03-2019 (#0813648)
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 M/s Sanofi,
Reference Regulatory Authorities 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, 2018 has
Applicant F-24/1, Eastern Industrial Zone, Port Qasim, Karachi, Pakistan
Brand Name +Dosage Form + Strength Kinza 10mg/ml Ampoule
Nalbuphine Hcl…10mg
03-2019 (#0841036)
Pharmacological Group Potent analgesic.
Form Form-5
Approval status of product in NUBAIN – (nalbuphine hydrochloride) injection for
Reference Regulatory Authorities intramuscular, subcutaneous, or intravenous (USFDA).
Me-too status Sonotic injection of M/s Brookes Pharma (Reg. # 057729)
Brand Name +Dosage Form + Strength Gentasis 80mg/2ml vial

Gentamicin as Gentamicin Sulphate…80mg
03-2019 (#0842238)
Form Form-5
As per SRO
Approval status of product in Gentamicin 40mg/ml Injection 80 mg/ 2 ml – Clear, Type I
Reference Regulatory Authorities glass vials (MHRA Approved)
Me-too status Refobacin 80mg/2ml Injection by AD Marker Quetta (Reg.
#006473)
Decision: Approved
1144. Name and address of manufacturer / M/s Invictus Pharmaceuticals.
Applicant Plot No. 21,26, Street No.NS-2, National Industrial Zone,
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Alevic Tablet 70mg
Alendronate (As Sodium) Trihydrate …70mg
02-2019 (#0825835)
Pharmacological Group Bisphosphonate, for the treatment of bone diseases
Form Form-5
Approval status of product in Alendronate sodium 70 mg USFDA Approved
Me-too status Bonfit 70mg tablets of M/s Searle Pak (Reg. # 045429)
GMP status 13-11-2018, The panel recommended the grant
DML.
Remarks of Evaluator VII In RRA Alendronate (As Sodium) Trihydrate”. On
communication the firm change its form 5 and master
formulation without fee.
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Diclo-In 50mg Tablet
02-2019 (#0825822)
Form Form-5

Approval status of product in Voltaren Tablets (25mg & 50mg) enteric coated by M/s
Reference Regulatory Authorities NOVARTIS Pharma, TGA Austrailia Approved.
Me-too status Diclopal Tablet (delayed released) 50mg by M/s Palpex
Pharmaceuticals, Reg. No. 82298
DML.
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Invoflox 500mg Tablet
Levofloxacin as hemihydrate …500mg
02-2019 (#0825812)
Form Form-5
Approval status of product in Levofloxacin (250mg & 500mg) Film-coated Tablets by M/s
Reference Regulatory Authorities Accord Healthcare Limited, MHRA Approved
Me-too status Cubac Tablets 250mg by M/s Schazoo Labs, Reg. No. 47943
DML.
Remarks of Evaluator VII In RRA it is approved as film coated tablet
Decision: Deferred for clarification of applied formulation since reference product is film coated
whereas firm has applied for tablet.
Applicant Plot No. 21,26, Street No. NS-2, National Industrial Zone,
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Cyclopin SR 30mg Capsule
Extended release Cyclo benzaprine HCL…15mg
02-2019 (#0825815)
Form Form-5
Approval status of product in Amrix extended release capsule (15mg, 30mg) by M/s Teva
Reference Regulatory Authorities Pharms intl, (USFDA Approved).
Me-too status Flexagil XR Capsule 30mg by M/s CCL Pharma
(Reg#78920)
DML.
Remarks of Evaluator VII Source of pellets is vision pharma
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Repra 20mg Capsule

Rabiprazole sodium as enteric coated pellets …20mg
02-2019 (#0825813)
Form Form-5
Me-too status Repit by Rabeptaole 20 mg by Sharooq065994
DML.
Remarks of Evaluator VII Evidence in RRA and Me too needed. (provided reference of
Aciphex sprinkle capsule is in 5 and 10 mg)
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting.
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Relax Tablet 5/160mg Tablet
Valsartan…160mg
02-2019 (#0825818)
Form Form-5
Approval status of product in Exforge 5/160mg film-coated tablets by M/s Novartis Pharma,
Me-too status Amsart 5/160mg Tablet by M/s Genetics Pharmaceutical (Pvt)
Ltd, Reg. No. 84098
DML.
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Quietus 25mg Tablet
02-2019 (#0825832)
Form Form-5
Approval status of product in Quetiapine film coated tablet (25mg, 100mg, 150mg, 200mg)
Reference Regulatory Authorities by M/s Aurobindo pharma, MHRA Approved

Me-too status Qusel Tablet (25mg, 100mg, 200mg) by M/s Hiltonpharma,
Reg No. 37684 37685 37690
DML.
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Articam 7.5mg Tablet
Meloxicam…7.5mg
02-2019 (#0825824)
Form Form-5
Approval status of product in MOBIC® (meloxicam) uncoated Tablets 7.5 mg by M/s
Reference Regulatory Authorities Boehringer Ingelheim Pharmaceuticals, Inc. USFDA
Approved.
Me-too status Orthicam Tablet 7.5mg by M/s Linear Parma,, (Reg No. 81878)
DML.
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Invefine 250mg Tablets
Terbinafine as HCL…250mg
02-2019 (#0825826)
Pharmacological Group Antifungal
Form Form-5
Approval status of product in Lamisil® Tablets 250mg by M/s NOVARTIS
Reference Regulatory Authorities PHARMACEUTICALS UK LIMITED, MHRA Approved.
Me-too status Logirid Tablet 250mg by M/s Lowitt Pharmaceutical (Reg No.
80847)
DML.
Decision: Approved
1153. Name and address of manufacturer / M/s Invictus Pharmaceuticals. Plot No. 21,26, Street No.NS-2,
Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Articam 15mg Tablet
Meloxicam…15mg
02-2019 (#0825825)

Form Form-5
Approval status of product in MOBIC® (meloxicam) uncoated Tablets 15 mg by M/s
Reference Regulatory Authorities Boehringer Ingelheim Pharmaceuticals, Inc.USFDA Approved.
Me-too status Mexiran Tablets 15mg by M/s Akson Pharmaceutical (Pvt) Ltd,
Reg. No. 29846
DML.
Decision: Approved
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Urosol 10mg Tablets
Solifenacin as Succinate…10mg
02-2019 (#0825828)
Form Form-5
Finished product Specifications Manufacturing specification
2x10’s
As per SRO
Approval status of product in Vesicare® (5mg& 10mg) film-coated tablet by M/s Astellas
Me-too status Solifen Tablet 10mg by M/s Getz Pharma, Reg. No. 61203
DML.
VII
Remarks of Evaluator In RRA Film coated tablet on communication the firm change
its form 5 and master formulation without fee.
Decision: Deferred for 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
Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Vital 500mcg Tablet
Composition Each sugar-coated tablet contains:
Mecobalamine …500mcg
02-2019 (#0825819)
Pharmacological Group Coenzyme type/Vitamin B12
Form Form-5
Approval status of product in Approved by PMDA of Japan
Me-too status Mecomed 500mcg by Global Pharma (Reg. No. 041670)

DML.
Decision: Approved
1156. Name and address of manufacturer / M/s Invictus Pharmaceuticals. Plot No. 21,26, Street No. NS-2,
Applicant National Industrial Zone, Rawat, Rawalpindi
Brand Name +Dosage Form + Strength Invefine 125mg Tablets
02-2019 (#0825827)
Form Form-5
Approval status of product in Lamisil® Tablets 125mg by M/s Novartis Pharmaceuticals
Reference Regulatory Authorities Australia Pty Limited, TGA Australia approved.
Me-too status Logirid Tablet 125mg by M/s Lowitt Pharmaceutical (Pvt) Ltd,
Reg No. 80846
DML.
Decision: Approved
Rawat, Rawalpindi
By
M/s News Pharma.
42-Sundar Industrial Estate, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength D-Pain Injection
Lignocaine …20mg
(Water for Injection…2ml)
03-2019 (#0849770)
Pharmacological Group NSAID/Local anesthic
Form Form-5
Pack size & Demanded Price 5x2 ml
10x2 ml
As per SRO
Approval status of product in Diclofenac-Mepha 75 ampoules for IM injection (SwissMedics
Me-too status Dyclo Plus 2ml Injection by Indus Pharma (#076107)
GMP status M/S s Invictus
13-11-2018, The panel recommended the grant of DML.
M/S News Pharma
GMP Inspection of News Pharma Conducted on 26-4-2018.
GMP Certificate is provided.
Remarks of Evaluator VII Total sections: 5
Products on contract: Nil
Decision: Deferred for capacity assessment of M/s News Pharma. 42-Sundar Industrial Estate,
Raiwind Road, Lahore
Rawat, Rawalpindi
By
M/s News Pharma.
Brand Name +Dosage Form + Strength Inlife-D Injection 5mg
Cholecalciferol Vit d3…5mg
03-2019 (#0849768)
Form Form-5
As per SRO
Approval status of product in Vitamin D3 Good 200,000 IU / 1 ml IM solution for injection
Reference Regulatory Authorities of (ANSM France approved)
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
13-11-2018, The panel recommended the grant
DML.
M/S News Pharma
Rawat, Rawalpindi
By
M/s News Pharma.
Brand Name +Dosage Form + Strength I-Fort Injection
Iron sucrose complex eq to elemental iron…100mg
03-2019 (#0849769)
Pharmacological Group Iron supplement
Form Form-5
Approval status of product in Venofer Injection by Vifor
Reference Regulatory Authorities (MHRA Approved)
Me-too status Vortex 100mg/ 5ml injection of Saturn Pharma
DML.
M/S News Pharma

Rawat, Rawalpindi
By
M/s News Pharma.
Brand Name +Dosage Form + Strength Bitwel M 500mcg Injection
Mecobalamine.500mcg
Water for Injection…1ml
03-2019 (#0837030)
Pharmacological Group Coenzyme Type Vitamin B12
Form Form-5
Approval status of product in PMDA Approved
Me-too status Mexamine 500mcg/ml Injection of M/s Asian Continental
(Pvt.) Ltd, Karachi(Reg. # 057864)
DML.
M/S News Pharma
Rawat, Rawalpindi
By
M/s News Pharma.
Brand Name +Dosage Form + Strength X-Pain Injection 10mg
Nalbuphine Hcl …10mg
03-2019 (#0837029)
Form Form-5
10x1 ml
As per SRO
Approval status of product in Nubain Injection Par Pharm Inc
Reference Regulatory Authorities USA
Me-too status Nalfy Injection of M/s Vision Pharma (Reg. 081912)

DML.
M/S News Pharma
VII
Remarks of Evaluator No. of drugs on contract basis are Nil
and 5 sections are available in the applicant ‘s firm.
Rawat, Rawalpindi
By
M/s News Pharma.
Brand Name +Dosage Form + Strength Molig Injection
Paracetamol…150mg
03-2019 (#0849767)
Form Form-5
Pack size & Demanded Price 5x 2ml
10x2 ml
50x2 ml
As per SRO
Me-too status Pravos 150mg injection by M/s Sami Pharmaceuticals (Pvt)
Limited.
DML.
M/S News Pharma
VII
Remarks of Evaluator No. of drugs on contract basis are Nil
and 5 sections are available in the applicant‘s firm.
The firm change its formulation from
Each ml contains:
Paracetamol…150mg
Lignocaine …20mg
Water for Injection…1ml to
Each ml contains:
Paracetamol…150mg
With revised master formulation and form 5 provided, fee just
mentioned but draft not provided,
In RRA that revised forumalation could not be confirmed.
Decision:
Deferred for following reasons:
 capacity assessment of M/s News Pharma. 42-Sundar Industrial Estate, Raiwind Road,
Lahore

 Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were declared/approved by the Registration Board in its 275th meeting.
1163. Name and address of manufacturer / M/s Jaens Pharmaceutical Industries Pvt Limited. 28-km
Applicant Lahore-Sheikhupura Road, Sheikhupura
Brand Name +Dosage Form + Strength Brymol Eye Drops 2/5mg
Brimonidine Tartrate…2mg
Timolol as Maleate…5mg
03-2019 (#0807636)
Pharmacological Group Alpha- adrenergic receptor agonist and beta-adrenergic receptor
inhibitor
Form Form-5
Pack size & Demanded Price 5 ml As per SRO
Approval status of product in Combigan of USFDA approved
Me-too status Combigan of M/s Barrett hodgson
GMP status GMP certificate to M/s Jaens Pharmaceuticals was issued on
03/04/2019 issued on the basis of inspection dated 14/01/2019
Brand Name +Dosage Form + Strength Nazoline EyeDrops 0.012%
Naphazoline HCL…0.012%
02-2019 (#0807632)
Pharmacological Group Decongestant
Form Form-5
Pack size & Demanded Price 15,10, 5 ml
As per SRO
Approval status of product in Murine Irritation & Redness Relief (MHRA)
Me-too status Naphtears by Novartis pharma (pak) ltd
Brand Name +Dosage Form + Strength Sorsis Cream 50mg
Calcipotriol …50 mcg
02-2019 (#0807639)
Pharmacological Group Other antipsoriatics for topical use
Form Form-5

Approval status of product in Calcipotriol Cream 50 micrograms/g. MHRA approved
Me-too status Calcipot Cream Reg. No. 69823
Brand Name +Dosage Form + Strength Methlone Cream
Methylprednisolone Acetone…0.1%
02-2019 (#0807640)
Form Form-5
Pack size & Demanded Price 5,10, 15, 20, 25, 30 gm
As per SRO
Approval status of product in ADVANTAN methylprednisolone aceponate 1mg/g cream by
Reference Regulatory Authorities M/s Bayer Australia Ltd (TGA Approved)
Me-too status Advantan 0.1% w/w cream by M/s Bayer Health Care
(Reg#018644)
VII
Decision: Deferred from confirmation of segregated dispensing booth for steroidal cream as per
decision of Licensing Board.
Brand Name +Dosage Form + Strength Nazoline-P EyeDrops
Naphazoline HCL…0.025%
Pheniramine Maleate…0.3%
02-2019 (#0807633)
Form Form-5
Pack size & Demanded Price 15,10, 5 ml
As per SRO
Approval status of product in Naphcon-A by Alkon (USFDA)
Me-too status Ocucon-A Eye Drops Farmigea (Reg # 026351)
VII
Brand Name +Dosage Form + Strength Aclovir Cream 5%
Acyclovir…5%
02-2019 (#0807641)
Pharmacological Group Antivirals
Form Form-5
Pack size & Demanded Price 2,3,5,10 15 g
As per SRO
Approval status of product in Zovirax Cream by M/s GlaxoSmithKline MHRA
Me-too status Cycloz topical cream by M/s Ferozsons
Brand Name +Dosage Form + Strength Etrolic Eye Drops
Ketorolac Tromethamine…0.5% (5 mg)
02-2019 (#0807634)
Pharmacological Group Anti- inflammatory
Form Form-5
Approval status of product in Ketorolac tromethamine 0.5% eye drops by Apotex (MHRA
Reference Regulatory Authorities Approved)
Me-too status Ketrosan 0.5% Sterile Ophthalmic Solution of M/s Elko
Organisation (Reg. # 026391)
Brand Name +Dosage Form + Strength Sorsis B Ointment
Calcipotriol …50 microgram
Betamethasone as Dipropionate…0.5mg
02-2019 (#0807638)
Pharmacological Group Anti- psoriasis
Form Form-5
Pack size & Demanded Price 10, 15,20, 25, 30, 50 gm
As per SRO
Approval status of product in Dalbecal 50 microgram/ g + 0.5 mg/ g Ointment by M/s Teva
Reference Regulatory Authorities UK Limited (MHRA Approved)
Me-too status Daivobet Ointment by M/s Zam Zam corporation (Reg
#031379)
Brand Name +Dosage Form + Strength Tevost Eye Drops 40microgram

Travoprost…40microgram
02-2019 (#0807637)
Pharmacological Group Prostaglandin
Form Form-5
Pack size & Demanded Price 2.5ml As per SRO
Approval status of product in Travoprost 40 micrograms/ml eye drops, solution by TevabUK
Reference Regulatory Authorities Limited, (MHRA Approved)
Me-too status Travop ophthalmic solution 0.004% by Alza Reg. # 081621
Brand Name +Dosage Form + Strength Bexo Eye Drops 0.5%
Composition Each ml solution contains:
Betaxolol as HCL…0.5%
02-2019 (#0807635)
Pharmacological Group selective beta1 receptor blocker
Form Form-5
Approval status of product in Betaxolol 0.5% Eye Drops MHRA approved
Me-too status Betaxolol, 0.5% by Invotek Reg. # 026956
1173. Name and address of manufacturer / M/s Convell Laboratories. Saidu Sharif Swat, KPK
Applicant
Brand Name +Dosage Form + Strength Velzim 0.5mg Tablet
Alprazolam…0.5mg
03-2019 (#0604889)
Form Form-5
Finished product Specifications USP Specs
Pack size & Demanded Price 3×10’s As per SRO
Approval status of product in Xanax 0.50mg by M/s Pfizer, MHRA Approved
Me-too status Lydia 0.50mg Tablets by M/s. Wilshire Laboratories (Pvt) Ltd;
Reg No. 65705
GMP status M/S Convell:
Panel inspection dated 02-3-2019 for renewal of DML
Tablet section (Psychotropic) present
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Condip-D Tablet
Amlodipine besylate…5mg
hydrochlorothizaid…12.5mg
03-2019 (#0604875)
Form Form-5
Finished product Specifications USP Specs
Me-too status Zamlo-H by Zafa Pharma.
Remarks of Evaluator VII RRA not found
Decision: Deferred for Evidence of approval of applied formulation in reference regulatory
Applicant
Brand Name +Dosage Form + Strength Bromavel 3mg Tablet
Bromazepam…3mg
03-2019 (#0604884)
Pharmacological Group Benzodiazepines
Form Form-5
As per SRO
Approval status of product in Lexotan (3mg, 6mg) tablets by M/s Roche TGA Australia
Me-too status Lexgit 3mg Tablets by M/s Glitz Pharmaceuticals, Reg. No.
81422
VII
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Citamode Tablets 10mg
Escitalopram…10mg
03-2019 (#0807635)
Pharmacological Group Antidepressants
Form Form-5
Approval status of product in Cipralex 10 mg film-coated tablets (MHRA Approved)
Me-too status Lexopram Tablets 10 mg by Evolution pharma
Remarks of Evaluator VII Each film coated Tablet Contains:
Escitalopram (as oxalate)…10mg.
Firm has initially applied for uncoated tablet containing
escitalopram without oxalate salt. Later the firm revised its
formulation as per reference product submitting PKR 20,000/-
fee (#2015173) dated 18-08-2020.
Decision: Approved as each film coated Tablet Contains:
Escitalopram (as oxalate)…10mg.
1177. Name and address of manufacturer / M/s Convell Laboratories.
Applicant Swat, KPKM/s Goodman Laboratories.
No.5, Street No. S-5, National Industrial Zone, Rawat,
Rawalpindi
By
M/s Vision Pharmaceuticals.
Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Esvell 40mg IV Injection
Composition Each vial contains
Esomeprazole (as sodium)…40mg
03-2019 (#0807635)
Form Form-5
Approval status of product in Nexium IV 40mg/vial injection by M/s Astrazeneca Pharms
Reference Regulatory Authorities (USFDA approved)
Me-too status Esold 40mg/vial Injection of M/s Weather Folds
Pharmaceutical, Reg No. 74824Lexopram Tablets 10 mg by
Evolution pharma
Vision Pharma: Inspection date 11/02/2019, the panel
recommended issuance of GMP certificate.
Remarks of Evaluator VII Total sections of convell: 7 sections

Total products on toll: Nil
Applicant
Brand Name +Dosage Form + Strength Glimet 1 Tablets 1/500mg
Glimepiride…1mg
03-2019 (#0604876)
Form Form-5
Remarks of Evaluator VII Evidence of approval of applied formulation in reference
regulatory authorities/agencies which
were adopted by the Registration Board in its 275thmeeting
Applicant
Brand Name +Dosage Form + Strength Glimet 2 Tablets 1/500mg
Glimepiride…2mg
03-2019 (#0604877)
Form Form-5
Me-too status Diabold Plus Tablet (film-coated). Reg. No. 76012 GPRIDE-M
SR 2/500mg tablet (bilayer). Reg. No. 76307
VII
Remarks of Evaluator Evidence of approval of applied formulation in reference
regulatory authorities/agencies which
were adopted by the Registration Board in its 275thmeeting
Applicant
Brand Name +Dosage Form + Strength Broven Suspension 100mg/5ml
Ibuprofen…100mg
03-2019 (#0604873)
Form Form-5
Approval status of product in IBuprofen 100mg/5ml Oral Suspension of (MHRA Approved)
Me-too status Nuprin 100mg Suspension M/s Reign Pharma
Decision: Approved
Rawalpindi
By
Brand Name +Dosage Form + Strength Ketvell 30mg Injection
Ketorolac Tromethamine…30mg

03-2019 (#0807635)
Form Form-5
Approval status of product in TGA; Australia Approved as (I/M)
Me-too status Ketomal Injection of M/s Trigon Pharma
(Reg. # 074193)
Products: Nil
Decision: Approved
Rawalpindi
By
Brand Name +Dosage Form + Strength Mec 500mcg Injection
Composition Each 1 ml ampoule contains:
Mecobalamine…500mcg
03-2019 (#0807635)
Form Form-5
Approval status of product in TGA; Australia Approved as (I/M)
Me-too status Ketomal Injection of M/s Trigon Pharma
(Reg. # 074193)
Product: Nil
Decision: Approved.
1183. Name and address of manufacturer / M/s Convell Laboratories. Swat, KPK
Applicant
Brand Name +Dosage Form + Strength Mosif 400mg Tablet
Moxifloxacin Hcl…400mg
03-2019 (#0604878)
Form Form-5

Approval status of product in AVELOX (moxifloxacin as hydrochloride) 400mg tablets,
Reference Regulatory Authorities film-coated. USFDA approved
Remarks of Evaluator VII Firm has initially applied for uncoated tablet. Later the firm
revised its formulation as per reference product i.e. film coated
tablet submitting PKR 5,000/- fee (#2015174) dated 18-08-
2020.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Velzipine 5mg Tablet
Olanzapine...5mg
03-2019 (#0604885)
Pharmacological Group Neuroleptic
Form Form-5
Approval status of product in Olanzapine Actavis 5 mg Film-coated Tablets, from Actavis
Reference Regulatory Authorities Group Iceland. PL 30306/0164, MHRA Approved.
Me-too status Olanzapine-Sandoz 5mg Tablets. By Novartis Pharma,
Karachi. (Reg#064040)
2020.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Velzipine 10mg Tablet
Olanzapine...10 mg
03-2019 (#0604886)
Pharmacological Group Neuroleptic
Form Form-5
Approval status of product in Olanzapine Actavis 10 mg Film-coated Tablets
Me-too status Olanzpine 10 mg Tablets. By: Akson Pharmaceuticals Pvt Ltd.
Mirpur. (Reg.#081661)
2020.
Decision: Approved

Rawalpindi
By
Brand Name +Dosage Form + Strength Swazole 40mg IV Injection
Omeprazole as sodium…40mg
03-2019 (#0807635)
Form Form-5
Approval status of product in Omeprazole 40mg Powder for Solution for Infusion by M/s
Reference Regulatory Authorities Sandoz Limited, MHRA Approved.
Me-too status RISEK 40MG INJECTION. Reg. No. 45617
VII
Decision: Deferred for confirmation of applicant (Convell or Goodman) and deposited fee for
Applicant
Brand Name +Dosage Form + Strength Rel-X Forte Tablet 650mg
Paracetamol…650mg
Orphenadrine citrate…50mg
03-2019 (#0604879)
Pharmacological Group Skeletal muscle relaxant/Antipyretic Analgesic
Form Form-5
Me-too status Nuberol Forte Tablet by M/s Searle Pakistan Ltd,,
Reg.#027196
VII
Remarks of Evaluator Evidence in RRA
Applicant
Brand Name +Dosage Form + Strength Nac Tablets 100mg
Aceclofenac…100mg
03-2019 (#0807635)
Form Form-5

Approval status of product in Aceclofenac 100 mg film-coated Tablets by M/s Accord
Reference Regulatory Authorities Healthcare, MHRA Approved.
Me-too status Gratis Tablets 100mg BP by M/s Navegal, Reg. No. 43900
Remarks of Evaluator VII Firm revised its formulation from uncoated to film coated
without providing fee
Decision: Deferred for submission of requisite fee for revision of formulation as per the reference
product.
Applicant
Brand Name +Dosage Form + Strength Prelin Plus Capsule 150mg
Pregabalin…150mg
03-2019 (#0604887)
Pharmacological Group Anti epileptic
Form Form-5
Approval status of product in Lyrica of (USFDA approved)
Me-too status Gabica Capsule by M/s Getz Pharma (#048724)
Applicant
Brand Name +Dosage Form + Strength Prelin Plus Capsule 75 mg
Pregabalin…75mg
03-2019 (#0604880)
Form Form-5
Approval status of product in Lyrica of (USFDA approved)
Me-too status Gabica Capsule by M/s Getz Pharma (#047365)
Applicant
Brand Name +Dosage Form + Strength Quetil 100mg Tablet
Quetiapine as fumarate…100mg
03-2019 (#0508175)
Pharmacological Group Neuroleptic/dopamine receptor antagonist
Form Form-5
Approval status of product in Quetiapine film coated tablet (25mg, 100mg, 150mg, and
Reference Regulatory Authorities 200mg) by M/s Aurobindo pharma, MHRA Approved.
Me-too status Qusel Tablet (25mg, 100mg, 200mg) by M/s Hilton pharma,
Reg No. (37684, 37685, 37690)
Remarks of Evaluator VII The firm revised their formulation from Quetiapine fumarate
uncoated tablet to Quetiapine as fumarate film coated tablet.
Without the provision of fee.
product
Applicant
Brand Name +Dosage Form + Strength Quetil 25mg Tablet
Quetiapine fumarate…25mg
03-2019 (#0508174)
Form Form-5
Approval status of product in Quetiapine film coated tablet (25mg, 100mg, 150mg, and
Reference Regulatory Authorities 200mg) by M/s Aurobindo pharma, MHRA Approved.
Me-too status Qusel Tablet (25mg, 100mg, 200mg) by M/s Hilton pharma,
Reg No. (37684, 37685, 37690)
Remarks of Evaluator VII The firm revised their formulation from Quetiapine fumarate
uncoated tablet to Quetiapine as fumarate film coated tablet.
Without the provision of fee.
product.
Applicant
Brand Name +Dosage Form + Strength Velresp 2mg Tablet
Risperidone …2mg
03-2019 (#0508176)
Form Form-5
120/10 tablet
Approval status of product in Risperdal 2mg film coated tablet by M/s Janssen-Cilag Ltd,
Reference Regulatory Authorities MHRA approved.
Me-too status Risperidone-sandoz film coated tablet (1mg, 2mg, 3mg, 4m g)
by M/s Novartis, Reg No. 48832

2020.
Decision: Approved.
Applicant
Risperidone …1mg
03-2019 (#0508177)
Form Form-5
Me-too status Risperidone-sandoz film coated tablet (1mg, 2mg, 3mg, 4mg))
2020.
Decision: Approved.
Applicant
Composition Each Film coated tablet Contains:
Risperidone …3mg
03-2019 (#0508178)
Form Form-5
Me-too status Risperidone-sandoz film coated tablet (1mg, 2mg, 3mg, 4mg))
2020.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Velzo 10mg Tablet
Composition Each film coated tablet Contains:
Zolpidem as tartrate…10 mg

03-2019 (#0807635)
Form Form-5
Approval status of product in Stilnoct (5mg, 10mg) film-coated Tablets by M/s Sanofi,
Me-too status Olida 10mg Tablets of M/s Glitz Pharmaceuticals, Islamabad
(Reg.# 081418)
Decision: Approved.
1197. Name and address of manufacturer / M/s Cure Laboratories.
Applicant Plot # 11,12,NS-2 RCCI, Industrial Estate, Rawat, Islamabad
By
M/s Nicholas Pharmaceuticals.
Islamabad
Brand Name +Dosage Form + Strength Renom 1g Injection
Meropenem as trihydrate blended with anhydrous sodium
carbonate…1g
03-2019 (#0849676)
Form Form-5
Approval status of product in MERREM IV (as the trihydrate blended with anhydrous
Reference Regulatory Authorities sodium carbonate for re-constitution) of sterile meropenem
powder. (USFDA)
Me-too status Mopen 1gm Injection of M/s Hilton Pharma
GMP status M/S Necholas:
Last GMP inspection was conducted on 03/08/18
Conclusion:
“Keeping in view the above facts, detailed visit of facility
and supporting documents provided by the company, the
panel unanimously recommend the M/s Nicholas for the
grant of DML and sections:
1- Capsule(Cephalosporin)
2- Dry suspension section(Cephalosporin)
3- Dry powder Injectable section(Cephalosporin)
4- Dry powder Injectable section(Carbapenems)”
M/S Cure Labortries:
Dated 05-03-2019, Issuance of DML in 269th Meeting of CLB.
VII
Remarks of Evaluator Total sections: 3
Total products on toll: No
By
M/s Nicholas Pharmaceuticals.
Islamabad

Brand Name +Dosage Form + Strength Renom 500mg Injection
Meropenem as trihydrate…500mg
03-2019 (#0807635)
Form Form-5
Approval status of product in MERREM IV (as the trihydrate blended with anhydrous
Reference Regulatory Authorities sodium carbonate for re-constitution) of sterile meropenem
powder. (USFDA)
Me-too status Mopen 500mg Injection of M/s Hilton Pharma
GMP status Same As Above

By
Brand Name +Dosage Form + Strength Esocure 40mg Injection
Esomeprazole as Sodium…40mg
03-2019 (#0807480)
Form Form-5
Finished product Specifications Manufacturing specifications
Approval status of product in Nexium IV 40mg/vial injection by M/s ASTRAZENECA
Reference Regulatory Authorities PHARMS (USFDA approved)
Me-too status Esold 40mg/vial Injection of M/s Weather Folds
Pharmaceutical, Reg No. 74824
GMP status M/S Vision:
GMP Certificate issued on 08.05.2018.
VII
By
Brand Name +Dosage Form + Strength P-Role 40mg Injection
03-2019 (#0807479)
Form Form-5
Finished product Specifications Manufacturing specicifcations

VII
By
Brand Name +Dosage Form + Strength Quantum 5mg Injection
Cholecalciferol …5mg
03-2019 (#0807483)
Form Form-5
Approval status of product in Vitamin D3 Good 200,000 IU / 1 ml IM solution for injection
Reference Regulatory Authorities of ( ANSM France approved)
GMP inspection dated 11-2-2019 concluding good GMP
complaience
Remarks of Evaluator VII Each Ampoule (1ml) Contains:
Cholecalciferol (Vitamin D3)…200,000 IU Eq. to 5mg/ml
Total sections: 3
By
Brand Name +Dosage Form + Strength Mecomet 500mcg Injection
03-2019 (#0807481)
Form Form-5
Finished product Specifications Manufacturing specifications
Pack size & Demanded Price 1 ml ampoule type 1
As per SRO
Approval status of product in Comezengen injection 500 μg of M/s Tatsumi Chemical
Reference Regulatory Authorities (PMDA Japan Approved)
Me-too status Flench injection of M/s Tabros Pharma
(Reg. # 029050)
1203. Name and address of manufacturer / M/s Goodman Laboratories.
Applicant No.5, Street No. S-5, National Industrial Zone, Rawat,
Rawalpindi
By
Brand Name +Dosage Form + Strength Spasmed 40mg Injection
Pholoroglucinol dihydrate…40mg
03-2019 (#0807635)
Pharmacological Group Musculotropic/Spasmolytic
Form Form-5
Me-too status NA
Remarks of Evaluator VII RRA and Me too not confirmed
• Evidence of approval of applied formulation in reference regulatory authorities / agencies
which were adopted by the Registration Board in its 275th meeting.
• Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
1204. Name and address of manufacturer / M/s Goodman Laboratories.
Applicant No.5, Street No. S-5, National Industrial Zone, Rawat,
Rawalpindi
By
Brand Name +Dosage Form + Strength Omega D 3 5mg Injection
Omeprazole…40mg
03-2019 (#0807635)
Pharmacological Group Musculotropic/Spasmolytic
Form Form-5
1205. Name and address of manufacturer / M/s Vision Pharmaceuticals, 22-23,
Applicant Industrial triangle Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Examic injection

03-2018 (#0732783)
Form Form-5
Pack size & Demanded Price 10 ml, As per SRO
Approval status of product in Tranexamic Acid Iv Apotex tranexamic acid 1000 mg/10 mL
Reference Regulatory Authorities solution for injection vial
Me-too status Transolide by GLOBAL is as 1000mg/10 ml
GMP status M/S Vision Pharma:
Decision: Approved
1206. Name and address of manufacturer / M/s Medisearch Pharma Pvt Ltd
Applicant 5-Km, Raiwind Manga Road, Lahore
Brand Name +Dosage Form + Strength P Caf Tablet 500mg/65mg
Paracetamol…500mg
Caffeine…65mg
03-2019 (#0845763)
Pharmacological Group Analgesic /Xanthine
Form Form-5
Pack size & Demanded Price 210 per
pack
As per SRO
Approval status of product in Panadol Extra Advance 500 mg/65 mg Film Coated Tablets by
Reference Regulatory Authorities M/s GSK, MHRA Approved.
Me-too status Paratol Extra tablet by M/s Highnoon (Reg.# 13346)
GMP status M/S Medisearch Pharma:
23-08-2019
Brand Name +Dosage Form + Strength Fenrate Capsule 200mg
Fenofibrate…200mg
03-2019 (#0846281)
Pharmacological Group Lipid Regulating agent
Form Form-5
Approval status of product in Fenofibrate 200 mg ( MHRA approved)
Me-too status Corfibrate 200mg Capsule by M/s OBS (Reg.# 073646)
23-08-2019
VII
Remarks of Evaluator In RRA micronized fenofibrate is used
Brand Name +Dosage Form + Strength Rostatin 10mg Tablet

Rosuvastatin Calcium…10mg
03-2019 (#0846278)
Form Form-5
Approval status of product in Crestor (rosuvastatin as calcium) (5mg, 10mg, 20mg, 40mg)
Reference Regulatory Authorities film coated tablet by M/s IPR, USFDA Approved.
Me-too status Rosulin Tablets 10 mg tablet by M/s Highnoon Labs, Reg.#
048372
23-08-2019
Remarks of Evaluator VII In RRA Rosuvastatin calcium is approved but the applied
product is just Rosuvastatin
Decision: Deferred for consideration on its turn with correction as per reference regulatory
authority
Brand Name +Dosage Form + Strength Rostatin 20mg Tablet
Rosuvastatin Calcium…20mg
03-2019 (#0846279)
Form Form-5
Approval status of product in Crestor (rosuvastatin as calcium) (5mg, 10mg, 20mg, 40mg)
Reference Regulatory Authorities film coated tablet by M/s IPR, USFDA Approved.
Me-too status Rosulin Tablets 10 mg tablet by M/s Highnoon Labs, Reg.#
048372
23-08-2019
VII
Remarks of Evaluator In RRA Rosuvastatin calcium is approved but the applied
product is just Rosuvastatin
Decision: Deferred for consideration on its turn with correction as per reference regulatory
authority
1210. Name and address of manufacturer / M/s Standpharm Pakistan Pvt. Ltd. 20-km, Ferozepur Road,
Applicant Lahore
Brand Name +Dosage Form + Strength C-Pime 1g Injection
Diary No. Date of R& I & fee Form-5 Dy.No 26376 dated 28-12-2017 Rs. 20,000 Dated 28-
12-2017
Cefepime (as hydrochloride) …1000 mg
(With L-arginine)
Type of Form Form-5
Pack Size & Demanded Price 600/Rs per vial
Approval Status of Product in Cefipime hydrochloride 1gm Injection by M/s Hospira, Inc
Reference Regulatory Authorities. (USFDA approved)
Me-too Status Nuxipim 1g Injection of Bosch

GMP status Last GMP inspection Date: 18-02-2020, panel recommend
renewal of DML
Decision: Deferred for the confirmation of manufacturing facility of the applied product
(Cephalosporin section)
Applicant Lahore
Brand Name +Dosage Form + Strength C-Pime 250mg Injection
12-2017
Cefepime (as hydrochloride) …250 mg
(With L-arginine)
Type of Form Form-5
Pack Size & Demanded Price 1’s
150 Rs per vial
Approval Status of Product in NA
Me-too Status Avetek of Aventek Pharma
renewal of DML
Remarks of the Evaluator. Evidence of applied formulation in RRA
 For the confirmation of manufacturing facility of the applied product (Cephalosporin
section)
Applicant Lahore
Brand Name +Dosage Form + Strength C-Pime 500 mg Injection
12-2017
Cefepime (as hydrochloride)…250 mg
(With L-arginine)
Type of Form Form-5
339 Rs per vial
Approval Status of Product in MAXIPIME for Injection 500mg Injection by M/s Hospira, Inc.
Me-too Status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060251)
renewal of DML
Applicant Lahore
Brand Name +Dosage Form + Strength Aspam Injection
12-2017
Composition Each Vial Contaiins:
Phloroglucinol…40mg
Trimethyl Phloroglucinol…0.04mg
Type of Form Form-5
339 Rs per vial
Approval Status of Product in Cefipime hydrochloride 500mg Injection by M/s Hospira, Inc.
Me-too Status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060251)
renewal of DML
Remarks of the Evaluator. In RRA
Each ampoule contains: Phloroglucinol Dihydrate…40mg
Decision: Deferred for evidence of approval of applied formulation as “Phloroglucinol” without
hydrate 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
Applicant Lahore
Brand Name +Dosage Form + Strength Epimate 25mg Tablets
Diary No. Date of R& I & fee Form-5 Dy. No 26380 dated 28-12-2017 Rs. 20,000 Dated 28-
12-2017
Topiramate……25mg
Pharmacological Group Anti-convulsion
Type of Form Form-5
Pack Size & Demanded Price 3x 10’s
15.16/ tablet
Approval Status of Product in Topamax Approved in US-FDA
Me-too Status Erbro 25mg Tablet of M/s Shawan Pharmaceuticals
renewal of DML
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength Epimate 100 mg Tablets
12-2017
Topiramate……100 mg
Pharmacological Group Anti-convulsant
Type of Form Form-5
Pack Size & Demanded Price 3x10’s
28.73/tablet
Approval Status of Product in Topamax (MHRA approved)
Me-too Status Tics 100mg tablets of M/s Genix pharma

renewal of DML
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength Epimate 50 mg Tablets
12-2017
Topiramate……50 mg
Type of Form Form-5
22.83/tablet
Approval Status of Product in Topamax (MHRA approved)
Me-too Status Erbro 50mg Tablet of M/s Shawan Pharmaceuticals
renewal of DML
Decision: Approved.
Applicant Lahore
Brand Name +Dosage Form + Strength Aspam 80/80mg Tablet
12-2017
Phloroglucinol (dihydrated corresponding to
Phloroglucinol)….. …………80mg
Trimethylphloroglucinol………….80mg
Type of Form Form-5
Finished Product Specification Manufacturer
493/ pack
Approval Status of Product in Spasfon sugar coated (ANSM) France Approved
Me-too Status Spasfon tablet of M/s Himont Pharmaceuticals (Reg.# 018529)
renewal of DML
Remarks of the Evaluator. Firm applied as film coated while the product is approved in
France as sugar-coated tablet. On communication revised form
5 along with fee of 5000/- (#1931656) dated 18-7-2019 was
provided.

1218. Name and address of manufacturer / M/s. Synchro Pharma, 77 Industrial Estate KotLakhpat, Lahore
Applicant
Brand Name +Dosage Form + Strength Duset oral dispersible tablet 4 mg
Diary No. Date of R& I & fee Form-5 Dy.No 14073 dated 7-3-2019 Rs. 20,000 Dated 6-3-
2019 (#0800704)
Composition Each orodispersible Tablet Contains:
Ondansetron as HCL Dihydrate…4mg

Pharmacological Group Serotonin 5-HT3 receptor antagonist
Type of Form Form-5
Approval Status of Product in Zofran tablet of Novartis (MHRA)
Me-too Status Zofran tablet of Glaxo lab (020667)
GMP status Last GMP inspection Date: 12-6-2019 and 04-7-2019, with
acceptable cGMP compliance
Remarks of the Evaluator. The firm revised there form 5 and method of manufacturer
from orodispersible Tablet Contains:
Ondansetron as HCL Dihydrate…4mg to
Ondansetron as HCL Dihydrate…4mg which is according
to the reference product with fee of 5000/- (#0800720)
dated 11/8/2020

1219. Name and address of manufacturer / M/s. Synchro Pharma, 77 Industrial Estate KotLakhpat, Lahore
Applicant
Brand Name +Dosage Form + Strength Duset oral dispersible tablet 8 mg
Diary No. Date of R& I & fee Form-5 Dy. No 14073 dated 7-3-2019 Rs. 20,000 Dated 6-3-
2019 (#0800705)
Composition Each orodispersible Tablet Contains:
Ondansetron as HCL Dihydrate…8mg
Pharmacological Group Serotonin 5-HT3 receptor antagonist
Type of Form Form-5
Approval Status of Product in Zofran tablet of Novartis (MHRA)
Me-too Status Zofran tablet of Glaxo lab (020668)
GMP status Last GMP inspection Date: 12-6-2019 and 04-7-2019, with
acceptable cGMP compliance
Remarks of the Evaluator. The firm revised there form 5 and method of manufacturer
from orodispersible Tablet Contains:
Ondansetron as HCL Dihydrate… to
Ondansetron as HCL Dihydrate…which is according to the
11/8/2020
1220. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt) Ltd, 62-Industrial Estate, Kot
Brand Name +Dosage Form + Strength Co-Valstar 160/12.5 Tablets
Diary No. Date of R& I & fee Diary No. 315, Date: 10-8-2015, 20,000/-

Valsartan …160 mg
Hydrochlorothiazide….12.5mg
Pharmacological Group Anti-hypertensive combination
Type of Form Form-5
As Per SRO
Approval status of product in Exforge Hct of (USFDA Approved)
Me-too status Exforge Hct of M/S Novartis Pharma
GMP status Firm has submitted copy of GMP inspection report conducted
on 20-04-2018 & 24-04-2018, concluding satisfactory level of
GMP compliance.
Decision: Approved.
1221. Name and address of manufacturer M/s Welmed Pharmaceuticals Industries (Pvt) Ltd. Plot #
/ Applicant 108, R:2, Industrial Estate Gadoon, Swabi
Brand Name +Dosage Form + Vil-Met 50/850 mg Tablet
Strength
Vildagliptin…50mg
11-02-2019 (#0846611)
Form Form-5
Reference Regulatory Authorities hydrochloride 850 mg film coated tablet. TGA approved
Me-too status GALVUS MET 50MG/850MG TABLETS (Reg # 66106)
GMP status M/s: Welmed
Last GMP inspection conducted on 12-12-2018 and report
concludes the firm has rectified majority of observations
noted in the previous inspection and the management is
committed to further improve their cGMP compliance.
The firm may be considered to be operating in satisfactory
Brand Name +Dosage Form + Vil-Met 50/1000mg Tablet
Strength
Vildagliptin…50mg
Diary No. Date of R& I & fee Form-5 Dy.No 5898 dated 11-02-2019 Rs.20,000/- Dated
11-02-2019 (#0846612)
Form Form-5
Reference Regulatory Authorities hydrochloride 1000 mg film coated tablet. TGA approved
Me-too status Valiant-M Tablets. (Reg No. 0773391)

Brand Name +Dosage Form + Tramal SR 100mg Tablet
Strength
Composition Each film coated sustained release tablet contains:
Tramadol Hcl…100mg
11-02-2019 (#0846608)
Form Form-5
Approval status of product in TRAMADOL SANDOZ SR tramadol hydrochloride
Reference Regulatory Authorities 100mg modified release tablet. TGA approved
Me-too status Opadol SR Tablet 100mg by Leads phrma. (Reg No.
065306)
Decision: Approved
Brand Name +Dosage Form + Rabi Med 20mg Tablet
Strength
Rabeprazole as Sodium…20mg
11-02-2019 (#0846607)
Form Form-5
Approval status of product in Rabeprazole 20mg Gastro resistant Tablets of Accord
Reference Regulatory Authorities healthcare limited (MHRA approved)
Me-too status Rabz 20mg Tablet of M/s Wilshire Pharma (Reg#037482)

VII
Remarks of Evaluator In RRA the tablet is as Rabeprazole 20mg Gastro resistant
Tablets but firm applied as enteric coated tablet.
Brand Name +Dosage Form + Ebacin 5mg/5ml Syrup
Strength
Ebastine…5mg
11-02-2019 (#0846605)
Form Form-5
Approval status of product in Ebastel oral solution 1mg/ml of Almirall, Spanish
Reference Regulatory Authorities medicine agency
Me-too status Olivestin Syrup of M/ Hiranis Karachi (Reg.#076519)
Brand Name +Dosage Form + Ebacin 20mg Tablet
Strength
Ebastine…20mg
11-02-2019 (#0846606)
Form Form-5
Approval status of product in Kestine 20 mg tablet (Approved in Ireland)
Me-too status Antine tablets 20 mg of M/s Wise Pharma
(Reg. # 068792)
Brand Name +Dosage Form + Doxefyl 400mg Tablet
Strength
Doxofylline…400mg
11-02-2019 (#0846604)
Pharmacological Group Systemic drugs for obstructive airway diseases
Form Form-5
Approval status of product in DOXOFILLINA ABC 400 mg uncoated tablet by M/s
Reference Regulatory Authorities ABC FARMACEUTICI SpA - Corso Vittorio, AIFA
(Italy)
Me-too status Profylline tablet 400mg by M/s Kaizen (Reg. # 73744)
Brand Name +Dosage Form + Doxifen 100mg Syrup
Strength
Doxofylline…100mg
11-02-2019 (#0846603)
Form Form-5
Approval status of product in Doxofillina ABC 20 mg / ml Syrup by M/s ABC
Reference Regulatory Authorities FARMACEUTICI SpA - Corso Vittorio (Italian Medicine
Agency (AIFA) Italy
Me-too status Profylline Syrup by Kaizen (R. No. 073749)
VII
Brand Name +Dosage Form + Levmed 25mg Tablet
Strength
Levosulpiride…25mg
11-02-2019 (#0846609)
Pharmacological Group Gastroprokinetic / psychosis / Neuroleptic
Form Form-5
Approval status of product in Levopraid 25 mg tablet of AIFA italy
Me-too status Nauvomit Tablets of M/s Saaaf Pharma (Reg#059377)
Brand Name +Dosage Form + Levmed 50 mg Tablet
Strength
Levosulpiride…50 mg
11-02-2019 (#0846610)
Pharmacological Group Gastroprokinetic / psychosis
Form Form-5
Approval status of product in LEVOPRAID 50 mg tablet by M/s TEOFARMA Srl
Reference Regulatory Authorities (AIFA Italy Approved).
Me-too status Vesulpid Tablets 50mg by M/s Martin Dow
Pharmaceutical (Pakistan) Ltd,(Reg#41012)
1231. Name and address of manufacturer / M/s Genome Pharmaceuticals Pvt Ltd.
Applicant Plot # 16/I-Phase IV, Industrial Estate, Hattar, KPK
Brand Name +Dosage Form + Strength Tegma 80/10 mg Tablet
Telmisartan…80mg
15-01-2019 (#0811381)
Pharmacological Group Angiotensin II antagonists and calcium channel blockers
Form Form-5
Approval status of product in Telmisartan and Amlodipine Tablets 10mg/80mg by M/s
Reference Regulatory Authorities Mylan Pharms INC (USFDA Approved)
Me-too status Misar-Am 80/10mg Tablet of M/s Highnoon Pharma (Pvt) Ltd
(Reg. # 069151)
GMP status GMP inspection dated 12.05.2018, concluded that overall the
firm was operating under good level of cGMP.
Remarks of Evaluator VII As an evidence of bilayer compression machine GMP dated 3-
5-2019 is provided in which double layered compression
machine is mentioned.
Decision: Approved
Telmisartan…80mg
15-01-2019 (#0811394)
Form Form-5
Approval status of product in Telmisartan and Amlodipine Tablets 5mg/80mg by M/s Mylan
Reference Regulatory Authorities Pharms INC (USFDA Approved)
Me-too status Amtas 5mg + 80mg Tablet of M/s Getz Pharma (Pvt) Ltd (Reg.
# 0669434)
Decision: Approved
Telmisartan…40mg
15-01-2019 (#0811393)
Form Form-5
Approval status of product in Telmisartan and Amlodipine Tablets 5mg/40mg by M/s Mylan
Reference Regulatory Authorities Pharms Inc. (USFDA Approved).
Me-too status Amtas 5mg + 40mg Tablet of M/s Getz Pharma (Pvt) Ltd.
Karachi. (Reg. # 066943)
Decision: Approved
1234. Name and address of manufacturer / M/s Siam Pharmaceuticals.
Applicant 217, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Amicell 50mg Tablet
Amisulpride…50mg
02-2019 (#0811873)
Pharmacological Group Benzamides
Form Form-5
Pack size & Demanded Price 1x 10, 3x10’s, 6x10’s As per SRO
Approval status of product in SOLIAN 50 amisulpride 50 mg uncoated tablet. TGA approved
Me-too status Ampisol 50mg Tablet (Reg# 76060)
GMP status M/s: Siam Pharmaceuticals Islamabad
16-02-2018
unanimously recommend grant renewal of DML 000711 for
approved tablet general and Capsule general section
Decision: Approved
Brand Name +Dosage Form + Strength Lacos 50mg Tablet
Lacosamide…50mg
02-2019 (#0841082)
Pharmacological Group Anticonvulsant
Form Form-5
Pack size & Demanded Price 1x14,28’s As per SRO
Approval status of product in Vimpat oral tablet of UCB Inc, USFDA Approved.
Me-too status Atcomid 50mg tablet of M/s Atco Pharma (Reg. # 075947).
16-02-2018
Brand Name +Dosage Form + Strength Sirbin 125mg Tablet

02-2019 (#0811867)
Pharmacological Group Antifungals for systemic use
Form Form-5
Approval status of product in LAMISIL terbinafine 125mg (uncoated tablets)
Reference Regulatory Authorities TGA Approved.
Me-too status "Terbizine Tablet of M/s Candid Pharma Lalap tablet of Hilton
pharma (Reg # 070118)
16-02-2018
VII
Remarks of Evaluator In RRA it is approved as Terbinafine HCl eq. to
Terbinafine…125mg" in uncoated form but firm applied as
Terbinafine HCl film coating tablet. On communication firm
rectify the form 5 and formulation without fee
product.
Brand Name +Dosage Form + Strength Sidone 40mg Capsule
Ziprasidone HCL…40mg
02-2019 (#0811869)
Form Form-5
Pack size & Demanded Price 1x10,2x7,3x10’s As per SRO
Approval status of product in GEODON®(ziprasidone HCl) capsules
Me-too status Zopeka 40mg Capsule
M/s Barret Hodgson, Karachi (Reg # 079550)
16-02-2018
Remarks of Evaluator VII In RRA it is approved as Ziprasidone as HCl but firm applied
as Ziprasidone HCl. On communication firm claimed that it’s
typographical mistake and rectify the form 5 and formulation
without fee.
product.
Brand Name +Dosage Form + Strength Fasgin 50mg Tablet
Lamotrigine…50mg
02-2019 (#0811876)
Pharmacological Group Other antiepileptic’s
Form Form-5
Approval status of product in Lamotrigine Accord 50 mg uncoated Tablets (MHRA
16-02-2018
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Deact 500mg Injection
12-2017
Sulbactum Sodium…250mg
Type of Form Form-5
Pack Size & Demanded Price 141 Rs/ vial
Approval Status of Product in PMDA, Japan Approved
Me-too Status 2- Sum 500mg injection of M/s Sami Pharma FOPERA of Jawa
pharma(Reg. # 079941)
renewal of DML.
Applicant Lahore
Brand Name +Dosage Form + Strength Cephdine 250 mg capsule
12-2017
Cephradine monohydrate eq to cephradine ….250 mg
Type of Form Form-5
Pack Size & Demanded Price 10.33/Rs per 2x6
Approval Status of Product in Cefradine 500mg Capsules by Athlone Pharmaceuticals
Me-too Status Dinar 500mg capsule by Baxter Pharma
renewal of DML.
Remarks of the Evaluator. Firm revised its formulation from cephradine to Cephradine
monohydrate eq to cephradine as per RRA with fee of 5000/-

(#0322077) dated 21-7-2019 was provided.
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Cephdine 500mg capsule
12-2017
Cephradine monohydrate eq to cephradine ….500mg
Type of Form Form-5
Pack Size & Demanded Price 20.3 per capsule
2x6
Approval Status of Product in Cefradine 500mg Capsules by Athlone Pharmaceuticals
Me-too Status Dinar 500mg capsule by Baxter Pharma
GMP status Last GMP inspection Date: 9-10-2017, with Satisfactory cGMP
compliance but ceph section is not truly dedicated.
Remarks of the Evaluator. Firm revised its formulation from cephradine to Cephradine
monohydrate eq to cephradine as per RRA with fee of 5000/-
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Cephdine 250mg/5ml Suspension
12-2017
Cephradine monohydrate eq to cephradine ……250mg
Type of Form Form-5
Pack Size & Demanded Price 141 Rs/ vial
Approval Status of Product in Cefradine 250mg/5ml dry powder for syrup by M/s Strides
Reference Regulatory Authorities. Pharma UK Ltd (MHRA Approved)
Me-too Status Licef Dry Powder suspension 250mg/5ml by M/s Wisdom
renewal of DML
Remarks of the Evaluator. In form 5, capsule is mentioned instead of suspension. Firm
claimed that it’s a typographical error and fee of 5000/-
Decision: Approved
Applicant Lahore
Brand Name +Dosage Form + Strength Citin 100mg/ml Syrup
12-2017
Citicoline (as Sodium)…. …100mg
Pharmacological Group Psychostimulants and nootropics
Type of Form Form-5
Pack Size & Demanded Price 600/ per 30 ml

1100 per 60 ml
Approval Status of Product in Citicolina Ferrer 100mg/ml Solucion Oral EFG by M/s Ferrer
Reference Regulatory Authorities. Internacional,S.A (Spain Approved)
Me-too Status Citolin Syrup by M/s Global Pharmaceuticals (Reg#029540)
renewal of DML
Remarks of the Evaluator. Firm revised its formulation from Citicolineto Citicoline (as
Sodium) as per RRA with fee of 5000/- (#0322079) dated 21-7-
2019 was provided.
1244. Name and address of manufacturer / M/s Mediate Pharmaceutical Pvt Ltd.
Applicant Plot No. 150-151, Sector 24, Korangi Industrial Area, Karachi,
Pakistan
Brand Name +Dosage Form + Strength Feno-Med 67mg Capsule
Fenofibrate(Micronized)…67mg
Diary No. Date of R& I & fee (Duplication)
Form-5 Dy.No 8324 dated 25-01-2019 Rs.20,000/- Dated 25-
01-2019 (#0836151)
Pharmacological Group Lipid modifying agent
Form Form-5
Approval status of product in USFDA Approved
Me-too status Fenoget 67mg micronized capsules of M/s Getz Pharma
(Reg. # 047197)
GMP status M/S Mediate Pharma
concludes was considered to be operating at acceptable level of
compliance with GMP guidelines
Remarks of Evaluator VII Physical form of API was not mentioned on communication
firm revised there form 5 with 5000/- fee (#2012042) dated 10-
6-2020
Decision: Approved
Pakistan
Brand Name +Dosage Form + Strength Feno-Med 200 mg Capsule
Fenofibrate…200 mg
Diary No. Date of R& I & fee (Duplication)
Form-5 Dy.No 8331 dated 25-01-2019 Rs.20,000/- Dated 25-
01-2019 (#0836152)
Form Form-5
Approval status of product in Fenofibrate (Micronized) USFDA
Me-too status Fenoget 200mg micronized capsules of M/s Getz Pharma
(Reg. # 047198))

Remarks of Evaluator VII Physical form of API was not mentioned on communication
firm revised there form 5 with 5000/- fee (#2012041) dated 10-
6-2020
Decision: Approved
Pakistan
Brand Name +Dosage Form + Strength Medinafine 250mg Tablet
terbinafine hydrochloride, equivalent to terbinafine …250mg
01-2019 (#0818181)
Form Form-5
Approval status of product in Lamisil® Tablets 250mg by M/s Novartis
Reference Regulatory Authorities Pharmaceuticals Uk Limited, MHRA Approved.
Me-too status Logirid Tablet 250mg by M/s Lowitt Pharmaceutical (Pvt)
Ltd, Reg No. 80847
Remarks of Evaluator VII Film coating is mentioned in master formulation but in RRA it
is approved as uncoated. Firm revised its formulation and form
5 as uncoated tablet with fee of 5000/- (#2012044) dated 16
june 2020
Decision: Approved
Pakistan
Brand Name +Dosage Form + Strength Medinafine 125 mg Tablet
terbinafine hydrochloride, equivalent to terbinafine …125 mg
01-2019
Form Form-5
Approval status of product in LAMISIL terbinafine 125mg (uncoated tablets) TGA
Me-too status "Terbizine Tablet
Candid Pharmaceuticals Reg No. 070118

Remarks of Evaluator VII Film coating is mentioned in master formulation but in RRA it
is approved as uncoated. Firm revised its formulation and form
5 as uncoated tablet with fee of 5000/- (#2012043) dated 16
june 2020
Decision: Approved
b. Deferred cases
1248. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No.224, Sector 23, Korangi
Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Irbesar Tablet 150 mg
Irbesartan … 150 mg
Diary No. Date of R& I & fee D#15716, 20-9-2017; Rs. 20,000/- (Slip# 0614799)

Form Form-5
Pack size & Demanded Price 10, 14,20,28, 30’s
As per SRO
Approval status of product in Reference Irbesartan 150 mg Film coated tablet by Accord Healthcare
Regulatory Authorities Limited, UK (MHRA approved)
Me-too status Gooday 150 mg by Wilson’s
GMP status Last GMP inspection was conducted on 10/04/18 and the report
concluded “Based on the areas inspected, the people met and
the documents reviewed, and considering the finding of
inspection, including the observations & advises made, M/s
High-Q Pharma is located at plot no.224, sector 23, Karachi
was considered to be operating at an acceptable level of
compliance with good manufacturing practices for Pharma
products.”
Remarks of Evaluator VII Firm revise their formulation as film coated tablet without
submission of fee.
Decision of 295:
Deferred for submission of fee for revision of formulation from uncoated tablet to film coated tablet.
Remarks of evaluator:
Firm revise their formulation as film coated tablet by submission of fee of Rs. 5000/- (#1983752) dated
10-6-2020
Decision: Approved.
1249. Name and address of manufacturer / M/s Dynatis Pakistan Pvt Ltd.
Applicant Plot No.710, Sundar Industrial Estate, Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Dyonate 50mg Tablets
Ibandronic Acid as ibandronic sodium monohydrate…50mg
02-2019 (#0519167)
Pharmacological Group Bisphosphonate
Form Form-5
Approval status of product in Reference NA
Me-too status NA

GMP status M/S Dynatis Pharma
Last GMP inspection report d ated 04-12-2018 recommends
grant of DML
Remarks of Evaluator VII Evidence of me too and RRA
Decision of 295:
Deferred for following:
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith
 Evidence of approval of applied formulation in reference regulatory authorities/agencies which were
declared/approved by the Registration Board
Remarks of evaluator:
RRA: Bondronat 50 mg film-coated tablets (MHRA)
Me too: Bondronat Tablets by hoffman La roch (#043008)
1250. Name and address of manufacturer / M/s Winlet Pharmaceuticals. 30-km, Lahore Sargodha
By
M/s Nicholas Pharmaceuticals. Plot # 34, St. # SS-02, National
Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Cilasten 500mg IV Injection
Imipenem as monohydrate…500mg
Cilastatin as Sodium…500mg
11-2018 (# 0811002)
Pharmacological Group Beta-lactam antibacterial
Form Form-5
Approval status of product in Reference Imipenem/Cilastatin 500 mg/500 mg, powder for solution for
Regulatory Authorities infusion by M/s Fresenius Kabi. (MHRA Approved)
Me-too status Cilapen 500mg injection by M/s Bosch (Reg. # 048491)
GMP status Last GMP inspection was conducted on 03/08/18
Conclusion:
1- Capsule (Cephalosporin)
2- Dry suspension section (Cephalosporin)
3- Dry powder Injectable section (Cephalosporin)
4- Dry powder Injectable section (Carbapenems)”
Decision:
Deferred for confirmation of already contract manufactured products.
Remarks of evaluator
Firm state that they don’t have any product being manufactured by contract as of 3-2-2020
Decision:
Deferred for capacity assessment of M/s Nicholas Pharmaceuticals.
By
Brand Name +Dosage Form + Strength Neopenem 500 mg IV Injection

Meropenem as Trihydrate …500 mg
Diary No. Date of R& I & fee Form-5 Dy.No 38582 dated 23-11-2018 Rs.50,000/-
Dated 23-11-2018 (# 0811004)
Pharmacological Group Carbapenems
Form Form-5
Approval status of product in Reference Meronem IV 500 mg Powder for solution for injection by M/s
Regulatory Authorities Pfizer Limited (MHRA Approved)
Me-too status Olver Injection by M/s Genix Karachi (Reg.# 080605)
Conclusion:
Decision:
Decision: Deferred for capacity assessment of M/s Nicholas Pharmaceuticals.
By
Brand Name +Dosage Form + Strength Neopenem 1g IV Injection
Composition Composition Each Vial Contains:
Meropenem as Trihydrate …1gm
Diary No. Date of R& I & fee
Dated 23-11-2018 (# 0811006)
Pharmacological Group Carbapenems
Form Form-5
Approval status of product in Reference Meronem IV 1g Powder for solution for injection by M/s Pfizer
Regulatory Authorities Limited (MHRA Approved)
Me-too status Penro 1000mg Injection IV by M/s Bosch (Reg. #
042107)
Conclusion:

Decision:
Decision: Deferred for capacity assessment of M/s Nicholas Pharmaceuticals.
1253. Name and address of manufacturer / M/s Novex Phamaceuticals, Plot No 54, S6 National Industrial
Applicant Zone Rawat Islamabad
Brand Name +Dosage Form + Strength Novocrom 4%w/v ophthalmic solution
Diary No. Date of R& I & fee Form-5 Dy.No 13676 dated 7-3-2019 Rs.20,000/- Dated 7-3-
2019 (Slip#1900338)
Composition Each ml ophthalmic solution contains: -
Sodium Cromoglicate …. 40 mg
Form Form-5
Pack size & Demanded Price 15- and 10-ml polyethylene bottle
As per SRO
Me-too status NA
Cromosol Eye Drops 4% M/S polyfine (#032455)
Deferred in 292
GMP status Panel inspection conducted on 12-02-2019 & 21-02-2019, and
the report concludes that the panel unanimously Recommended
M/s Novex Pharmaceuticals for the grant of DML
Remarks of the Evaluator. • Evidence of approval of applied formulation in same
strength and volume in reference regulatory
authorities/agencies which were declared/approved by the
Decision:
•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
Firm provided the following
RRA: Cromolyn sodium 4% ophthalmic solution (USFDA)
Me too: Sodium Cromoglycate 4% W/V (# 013156)
1254. Name and address of manufacturer / M/s Elite Pharma Pvt Ltd., P.D.H. Street 9.5 km Sheikhupura
Applicant Road, Lahore.
Brand Name +Dosage Form + Strength Gentalite 80 mg/2 ml injection
Composition Each 2 ml contains:
Gentamicin sulfate equivalent to Gentamicin…….80 mg
Diary No. Date of R& I & fee Dy.No. 11923, 15-8-2017, Rs.20,000/=

Type of Form Form-5
Pack size & Demanded Price 2ml x 5’s
2ml x 25’s/

As Per SRO
Approval status of product in Reference Cidomycin 80mg/2ml Solution for Injection by M/s Aventis
Regulatory Authorities. Pharma Limited, MHRA Approved.
Me-too status DBL Gentamicin 80mg/2ml injection
GMP status Last GMP inspection was conducted on 31-01-2018 and the
report concludes:
“It is advised to overcome the shortcomings and submit the
compliance report to the competent authorities so that the
inspection could be conducted accordingly.”
Remarks of Evaluator Show cause notice dated 11 Nov 2019 for the
Suspension of production in all sections was issued.
Decision 293:
Registration Board referred the case to QA & LT Division for updated GMP status of the firm.
Firm provided the resumption of production order in liquid injectable ampoule and semi-solid (cream,
ointment section only) dated 27 Dec 2019.
1255. Name and address of manufacturer / M/s Elite Pharma Pvt Ltd., P.D.H. Street 9.5 km Sheikhupura
Brand Name +Dosage Form + Strength Betavel ointment 5 gm Tube
Composition Each 5 gm ointment Contains:
Betamethasone as valerate………..0.1%
Diary No. Date of R& I & fee Dy.No. 11922, 15-8-2017, Rs.20,000/=
Type of Form Form-5
Pack size & Demanded Price Unit price, 12/-
Approval status of product in Reference BETA-VAL 0.1% ointment (USFDA)
Me-too status Betacin of Geofman Pharmaceuticals
report concludes:
“It is advised to overcome the shortcomings and submit the
compliance report to the competent authorities so that the
inspection could be conducted accordingly.”
Remarks of Evaluator Show cause notice dated 11 Nov 2019 for the
Suspension of production in all sections was issued.
Decision 293:
Registration Board referred the case to QA & LT Division for updated GMP status
of the firm.
Firm provided the resumption of production order in liquid injectable ampoule and semi-solid (cream,
ointment section only) dated 27 Dec 2019.
Decision: Approved
1256. Name and address of manufacturer / M/S Welwrd Pharmaceuticals, Plot No; 3, Block A, Phase I– II,
Applicant 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 USP (ophthalmic suspension)
Pack Size & Demanded Price 5ml As per SRO
Approval Status of Product in TOBRADEX by Novartis (USFDA 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 Evaluator VII 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
Firm revised the formulation with 20,000 fee (#2028796) dated 06/07/2020 to
Each ml suspension Contains:
Dexamethasone………… 0.1%
Tobramycin ………………0.3%
Decision: Deferred for confirmation of separate dispensing booth for steroidal ingredients.
1257. Name and address of manufacturer / M/s Nabiqasim Industries (Pvt.) Ltd., 17/24, Korangi Industrial
Applicant Area, Karachi.
Brand Name+ Dosage Form+ Strength Imuvir 500 mg Injection
Ganciclovir sodium equavent to Ganciclovir…….500 mg
(Lyophylized in container)
Diary No. Date of R&I & fee Duplicate/Via Letter No. F.1-2/2019-Reg-I dated 12th July
2019, originally received at 30-12-2014, Rs.Rs.20,000/- (5-11-
2014) (Duplicate)
Pharmacological Group Antiviral (Nucleoside analogue)
Type of Form Form-5
Finished Product Specification Manufacturer‟s Specification
Pack Size & Demanded Price 1‟s As per SRO
Approval status of product in Reference CYTOVENE-IV (USFDA) in a vile
Me-too status Ciganclor freeze dried for injection (Reg#047562)
GMP status Last inspection report dated 02-08-2018 concluded that M/s
Nabi Qasim Karachi is considered to be operating at an
acceptable level of compliance of cGMP Requirements at the
time of inspection.
Remarks of Evaluator VII No of contract manufactured products:29
Decision of 293:
Deferred for confirmation of manufacturing method (powder filling or lyophilization) and requisite
facility.
Remarks of evaluator VII
The Firm responded that as the innovators product cymevene IV is as sterile lyophilized powder so their
product is also in sterile lyophilized powder form. Approval of lyophilized vial section was also
provided.
Remarks:

Firm replied that the applied dosage form is by lyophilization and we are not using ready to fill
prelyophilized powder.
1258. Name and address of manufacturer M/s

/ Daneen Pharma Pvt Ltd. 27, Sundar industrial Estate,
Applicant Sundar Raiwind Raod, Lahore, Pakistan
Brand Name +Dosage Form + Strength Telart A Tablet 80mg/10mg
Telmisartan…80mg
Amlodipine as besylate Amlodipine…10mg
02-2019 (#0847614)
Pharmacological Group Anti-Hypertensive
Form Form-5
Approval status of product in Reference Telmisartan and Amlodipine Tablets 10mg/80mg by M/s Mylan
Regulatory Authorities Pharms INC (USFDA Approved)
Me-too status Misar-Am 80/10mg Tablet of M/s Highnoon Pharma (Pvt) Ltd
(Reg. # 069151)
Remarks of Evaluator VII It’s a bilayer tablet so Status of Availability of Bilayer
compression tablet facility have to confirm. Firm provides the
invoice of purchase of rotary tablet press machine (Blest
industries) was provided.
Decision of 295:
Deferred for submission of Installation Qualification (IQ), Performance Qualification (PQ) Reports of
required manufacturing equipment i.e. tablet biayered machine.
The Firm submitted the Installation Qualification (IQ), Performance Qualification (PQ) Reports of
1259. Name and address of manufacturer M/s / Daneen Pharma Pvt Ltd. 27, Sundar industrial Estate,
Telmisartan…40mg
02-2019 (#0847613)
Form Form-5
Telmisartan and Amlodipine Tablets 10mg/40mg by M/s Mylan
# 066945)
It’s a bilayer tablet so Status of Availability of Bilayer

Decision of 295:
Telmisartan…80mg
02-2019 (#0548110)
Form Form-5
Approval status of product in Reference Telmisartan and Amlodipine Tablets 5mg/80mg by M/s Mylan
# 0669434)
Decision of 295:
Composition Each bilayer Tablet Contains:
Telmisartan…40mg
02-2019 (#0798433)
Form Form-5
Telmisartan and Amlodipine Tablets 5mg/40mg by M/s Mylan
Regulatory Authorities Pharms Inc. (USFDA Approved).
Me-too status Amtas 5mg + 40mg Tablet of M/s Getz Pharma (Pvt) Ltd

Decision of 295:
Brand Name +Dosage Form + Strength Telart H Tablets 40mg/12.5mg
Telmisartan…40mg
02-2019 (#0798432)
Pharmacological Group Antihypertensive (Angiotensin II Receptor Antagonist, Thiazide
Diuretic)
Form Form-5
Approval status of product in Reference Micardis HCT of (USFDA Approved)
Decision of 295:
Brand Name +Dosage Form + Strength Doxo Tablet 400mg
Doxofylline…400mg
02-2019 (#0830203)
Form Form-5
DOXOFILLINA ABC 400 mg uncoated tablet by M/s ABC
Regulatory Authorities FARMACEUTICI SpA - Corso Vittorio, AIFA (Italy)
Me-too status Profylline tablet 400mg by M/s Kaizen, Reg no.
Antine tablets 20 mg of M/s Wise Pharma (Reg. # 73744)

Remarks of Evaluator VII In contrary to reference product which is available as uncoated
tablet firm has applied for film coated tablet in form 5. Upon
communication of above observations firm has submitted that
our applied formulation is uncoated as there is no coating
material in method of manufacturing but typographically we
mentioned film coated in form 5 were attached BMR is of
uncoated tablet.
Decision of 295:
Deferred for submission of fee for revision of formulation.
The Firm submitted the fee of 5000/- (#2036781) dated 21-08-2020 for revision of formulation from
film coated tablet to uncoated tablet.
1264. Name and address of manufacturer / M/s Daneen Pharma Pvt Ltd.
Applicant 27, Sundar industrial Estate, Sundar Raiwind Raod, Lahore,
Brand Name +Dosage Form + Strength Cefpro DS 40mg/5ml Oral Suspension
Cefpodoxime Proxetil Eq. to Cefpodoxime…40mg
01-2019 (#0801948)
Form Form-5
Pack size & Demanded Price 50, 75, 100 ml
As per SRO
Approval status of product in Reference Cefpodoxime 40 mg/5 ml oral by Aurobindo pharma (MHRA)
Me-too status Prelox of Bosch Pharma
GMP status As per last inspection report dated 08/03/2019, Same as Above.
VII
Remarks of Evaluator In RRA it is approved as granules for suspension
Decision of 295:
Decision: Deferred for the clarification of manufacturing outline as in reference regulatory authorities
the approved drug is granules for suspension need detail outline of granulation process.
The Firm submitted the manufacturing method and BMR with detail outline of granulation process in
line with RRA.
1265. Name and address of manufacturer / "M/s Medisave Pharmaceuticals., Plot 578-579, Sundar
Applicant Industrial Estate, Lahore, Pakistan"
Brand Name +Dosage Form+ Strength Thiocol capsule 4 mg
Diary No. Date of R& I & fee Form-5 Dy.No 5059E dated 7-6-2017 Rs 20,000/- Dated 2-6-
2017 (Slip#0608270)
Composition Each Capsule Contains: Thiocolchicoside as sustained release
pellets eq
Form Form-5
Approval status of product in Reference Myoplege 4mg capsule France
Regulatory Authorities (ANSM approved)
Me-too status Ezoside capsule 4mg of M/s Akhai Pharma (Reg. # 070427)
GMP status 11-12-2017 & 10-01-2018.
GMP Certificate issued on 15-03-2018.

Remarks of the Evaluator. Evidence of approval of applied formulation in reference
regulatory authorities could not be confirmed as sustained
release pellets.
If indeed applied as pellets then source of pellets is required to
be submitted.
Letter issued on24th Dec 2019
Decision of 293:
Deferred for evidence of approval of applied formulation in reference regulatory authorities / agencies
Firm submit the revised dossier for
Each capsule contains
Thiocolchicoside …4mg (Without fee)
RRA: Myoplege 4mg capsule France
(ANSM approved)
Me to: Ezoside capsule 4mg of M/s Akhai Pharma
(Reg. # 070427)
Decision of 295:
Deferred for submission of requisite fee for revision of formulation from Each Capsule Contains:
Thiocolchicoside as sustained release pellets eq
Thiocolchicoside…4mg to each capsule contain Thiocolchicoside …4mg
Firm again provided the revised form 5 with the copy of original 20,000/- fee. No fee of 5000/- was
submitted for revision of formulation.
product.
1266. Name and address of manufacturer / M/s Global Pharmaceuticals Pvt Ltd
Applicant Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Glunol Tablets 80/80mg
Phloroglucinol…80mg
Trimethylphloroglucinol…80mg
01-2019 (#0810185)
Form Form-5
As per SRO
Approval status of product in Reference Spasfon sugar- coated tablet by M/s Teva Health (ANSM)
Regulatory Authorities France Approved
Me-too status Anafortan Plus Tablets Each sugar-coated tablet of M/s Ali
Gohar (Reg.# 024504)
GMP status GMP inspection dated 20th & 24th April 2018 and the panel
recommendations “The firm was found to be satisfactory level
of GMP compliance”
M/s Global Pharma issued a letter dated 18th December 2017 of
additional section of dry powder (carbapenem)
Remarks of Evaluator VII In ANSM it is approved as anhydrous phloroglucinol
62.233 mg in the form of: hydrated phloroglucinol 80
mg but firm applied as phloroglucinol 80 mg.
Decision of 295:
Deferred for revision of formulation as per the reference product along with submission of requisite fee
for revision of formulation.

In ANSM it is approved as anhydrous phloroglucinol 62.233 mg in the form of: hydrated phloroglucinol
80 mg but firm applied as phloroglucinol 80 mg. Firm clarify that “there is a typographical mistake that
only phloroglucinol is mentioned this must be phoroglucinol dihydrate please considered this as
phloroglucinol dihydrate instead of phloroglucinol. Fee of 5000/- (2034909) dated 4- sep 2020.
1267. Name and address of manufacturer / M/s Global Pharmaceuticals Pvt Ltd
Applicant Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Glunol Injection 40/0.04mg
Dihydrated Phloroglucinol…40mg
01-2019 (#0810186)
Pharmacological Group Antispasmodic.
Form Form-5
Pack size & Demanded Price 4 ml in glass ampoule
6 and 10’s
As per SRO
Approval status of product in Reference Spasfon injection by M/s Teva Health (ANSM) France
Regulatory Authorities Approved (4 ml glass ampoule)
Me-too status Spasrid Injection of Barrett Hodgson Pakistan (Pvt) Ltd (Reg.#
034744)
GMP status GMP inspection dated 20th & 24th April 2018 and the panel
recommendations “The firm was found to be satisfactory level
of GMP compliance”
M/s Global Pharma issued a letter dated 18th December 2017 of
additional section of dry powder (carbapenem)
Remarks of Evaluator VII In ANSM it is approved as anhydrous phloroglucinol 31.12
mg in the form of: phloroglucinol dihydrate but firm applied as
Dihydrated Phloroglucinol…40mg
Decision of 295:
Deferred for revision of formulation as per the reference product along with submission of requisite fee
for revision of formulation.
The Firm submitted that “Our formulation initiall y submitted is phloroglucinol dihydrate not just
phloroglucinol which is according to innovators”. But the original query was that in ANSM it is
approved as anhydrous phloroglucinol 31.12 mg in the form of: phloroglucinol dihydrate not just
phloroglucinol dihydrate. Firm also provided the revised master formulation with the copy of original
fee of 5000/- (2034908) dated 4 sep 2020 was submitted for revision of formulation.
Case No. 03 Registration applications for local manufacturing of (veterinary) drugs

b. Deferred Cases
1268. Name and address of manufacturer / Applicant M/s Aptly pharmaceuticals, 5 Km, Sargodha
road Bypass, Faisalabad
Brand Name +Dosage Form + Strength Aoromox-C Powder
Diary No. Date of R& I & fee Dy.No.29875, 5-9-18, Rs. 20,000/-
Composition Each gm contains
Amoxicillin (base)....100 mg
Colistin sulphat …500,000IU
Type of Form Form-5

Pack size & Demanded Price 500 gm, 1 kg, 2.5 kg, 5 kg
Decontrolled
Me-too status Colimoxin Powder. (034583)
GMP status Last GMP Inspection Conducted on 6 August
2018 with conclusive remarks of good
compliance for grant of drug manufacturer
license by way of formulation in respect to
following sections
 Oral liquid General
 Oral liquid antibiotic
 Oral powder general
 Oral powder antibiotic
 Oral powder penicillin
Decision 293:
Deferred for verification of composition of applied formulation.
Colimoxin Powder of Salmore Pharma (Me too) is same as the applied formulation
1269. Name and address of manufacturer / Applicant M/s Aptly pharmaceuticals, 5 Km, Sargodha
road Bypass, Faisalabad
Brand Name +Dosage Form + Strength Gut treat plus Powder
Diary No. Date of R& I & fee Dy.No.29923, 5-9-18, Rs. 20,000/-
Composition Each kg contains

Procaine penicillin....12 gm
Streptomycin sulphate…...36 gm
Zinc bacitracin….. 52 gm
Colistin sulphate…. 60 MIU
Type of Form Form-5
Pack size & Demanded Price 500 gm, 1 kg, 2.5 kg, 5 kg
Decontrolled
Me-too status Pro Sb-Plus Powder (028508)
GMP status Last GMP Inspection Conducted on 6 August

2018 with conclusive remarks of good
compliance for grant of drug manufacturer
license by way of formulation in respect to
following sections
 Oral liquid General
 Oral liquid antibiotic
 Oral powder general
 Oral powder antibiotic
 Oral powder penicillin
Decision 293:
Deferred for verification of composition of applied formulation.
Pro Sb-Plus Powder (028508) of Medicure Lab (Me too) is same as the applied formulation
Case No. 04 Registration applications of categories to be considered on priority

Local manufacturing applications of priority categories defined by Registration Board in its 257 th
meeting
b. Export facilitation
Following cases of M/s Tabros Pharma Pvt Ltd. L-20/B, Sector-22, Federal B Industrial Area, Karachi were
received from PR-I/EFD vide letter No. F. 1-6/2019-PR.I (EFD) dated 17th August, 2020. According to the
contents of the letter the firm has claimed 3 molecules to be considered on priority against export worth
USD 875,668.61/- which is duly verified from submitted documents (Form E GD and shipment invoices) as
per the decision of Registration Board.
1270. Name and address of manufacturer / M/s Tabros Pharma Pvt Ltd.
Applicant L-20/B, Sector-22, Federal B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Linzoy Topical Gel 1.5%

Clindamycin as Phosphate…1%
Hydrous Benzoyl Peroxide eq.to anhydrous Benzoyl
Peroxide …5%
Diary No. Date of R& I & fee Form-5 Dy. No 16055 dated 07-03-2019 Rs.20,000/-
Dated 07-03-2019
Pharmacological Group Antibacterial
Form Form-5
Approval status of product in Reference Duac Once Daily 10 mg/g + 50 mg/g Gel
Regulatory Authorities (Approved in MHRA)
Me-too status Benclin Gel of M/s Elko Org. (Pvt), Ltd. 061908
GMP status Last inspection report 07/02/18, On the basis of

current inspection it was observed that the firm
rectified all observations noted during last GMP
Inspection.”
VII
Remarks of evaluator In RRA the reference product contains Anhydrous
Benzoyl Peroxide eq.to Hydrous Benzoyl Peroxide
but firm applied as Benzoyl peroxide on
communication the firm revised their formulation
from Benzoyl peroxide to Anhydrous Benzoyl
Peroxide eq.to Hydrous Benzoyl Peroxide with fee of
5000/- (# 1991807) dated 26 aug 2020
Applicant L-20/B,Sector-22, Federal B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Cutis Spray 1%

Composition Each 1 spray solution contains:
Terbinafine Hcl…10mg
(#0842622) Dated 07-03-2019
Form Form-5
Approval status of product in Reference Lamisil® AT 1% Spray by M/s GSK UK (MHRA
Me-too status Lamisil spray by M/s Novartis Pharma (Reg #
021173)

Inspection.”

Applicant L-20/B, Sector-22, Federal B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Fusil 250mg Tablet

Sodium Fusidate…250mg
(#0842625) Dated 06-03-2019
Form Form-5
Approval status of product in Reference Fucidin 250 mg Tablets of MHRA approved
Me-too status Pandate 250mg Tablets, film-coated. (Reg. No.
81426)
Inspection.”

Following cases of were received from PR-I/EFD vide letter No. F. 1-6/2019-PR.I (EFD) dated 17th
August, 2020. According to the contents of the letter the firm has claimed 3 molecules to be considered on
priority against export worth USD 102,656.27/- which is duly verified from submitted documents (Form E
GD and shipment invoices) as per the decision of Registration Board.
1273. Name and address of manufacturer / M/s Efroze Chemical Industries Pvt Ltd.
Applicant 146/23, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Efnor 0.75mg Tablet
Levonorgestrel…0.75mg
(# 082817) Dated 05-03-2019
Pharmacological Group Hormonal contraceptives for systemic use
Form Form-5
Approval status of product in Reference PLAN B (LEVONORGESTREL) by Duramed (USFDA)
Me-too status Emkit (LEVONORGESTREL) by Zafa Pharmaceutical
GMP status Last inspection report 19-3-2018, panel recommends

the grant of renewal of the DML by way of
formulation
Decision: Deferred for confirmation of segregated facility from Licensing Division DRAP

1274. Name and address of manufacturer / M/s Efroze Chemical Industries Pvt Ltd.
Applicant 146/23, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Gynacept 5mg Tablet
Norethisterone …5mg
(#0812819) Dated 05-03-2019
Pharmacological Group Progestogen
Form Form-5
Approval status of product in Reference Primolut N of MHRA approved
Me-too status Postpon-M Tablet by M/s OBS, (Reg# 073532)
GMP status Last inspection report 19-3-2018, panel recommends

the grant of renewal of the DML by way of
formulation
Remarks of evaluator VII Steroidal hormone section is required (Tablet
hormone section present)
Firm request change in brand name to “Gynacept
tablet 0.75”
Decision: Deferred for confirmation of segregated facility from Licensing Division DRAP
1275. Following cases of M/s S.J & G Fazul Ellahie were received from PR-I/EFD vide letter No. F. 1-
6/2019-PR.I (EFD) dated 17th August, 2020. According to the contents of the letter the firm has
claimed 3 molecule to be considered on priority against export worth USD 104,097/- which is duly
verified from submitted documents (Form E GD and shipment invoices) as per the decision of
Registration Board.
1276. Name and address of manufacturer / M/s S.J & G Fazul Ellahie Pvt Ltd.
Brand Name +Dosage Form + Strength Mega Gold Powder
Composition Each Kg Contains:
Vitamin A...0.8gm
Vitamin D3...0.16gm
Vitamin E...0.38gm
Vitamin B1...1gm
Vitamin B2...1.25gm
Vitamin B12...0.001gm
Vitamin B3...6.25gm
Vitamin B6...4gm
Copper Sulphate...0.25gm
Magnesium Sulphate...25gm
Calcium Chloride...0.023gm
Zinc Sulphate...2.17gm
Manganese Sulphate...10gm
Potassium Iodide...0.5gm
Sodium Selenite...0.01gm
D.C.P (Phosphorous)...150gm
Sodium Chloride...120gm
(#1953791) Dated 16-12-2019
Pharmacological Group Nutritional supplement
Form Form-5

Me-too status WHITE GOLD POWDER by Leads Pharma
(#'058842)
GMP status Inspection conducted on 15-01-2020 The firm is
recommended grant of GMP certificate.
Decision: Approved with innovator’s specification and change of brand name.
1277. Name and address of manufacturer / M/s S.J & G Fazul Ellahie Pvt Ltd.
Brand Name +Dosage Form + Strength Trisulf Powder
Trimethoprim…80mg
Sulphadiazine Sodium…420mg
(# 1936350) Dated 16-12-2019
Pharmacological Group Dihydrofolate reductase inhibitor and sulfonamide
antibacterial
Form Form-5
Me-too status NA
GMP status Inspection conducted on 15-01-2020 The firm is

recommended grant of GMP certificate.
Remarks of evaluator VII DRAP me too evidence needed
provided reference of cotrim powder (#049295) of
prix can’t be verified from data base
(generic / me-too status) along with registration number, brand name and name of firm
Case No. 05 Registration applications of import cases

1278. Name and address of Applicant M/S Bristal Mayer Biotech Pakistan, 73-B Guldasht town,
Zarrar Shaheed road, Lahore Cantt
Detail of Drug Sale License Address: M/S Bristal Mayer Biotech Pakistan, 73-B
Guldasht town Zarrar Shaheed road, Lahore Cantt Pakistan
Validity: 7-April- 2020
Status: License to sell drug as distributor
Name and address of manufacturer Vem ilac San. Ve Tic. A.S.
Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mahallesi. Fatih Bulvari. No 38
Kapakli/TEKIRDAG/Turkey
Name and address of marketing Vem ilac San. Ve Tic. A.S.
authorization holder Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mah. Fatih Blv. No 38 Kapakli/TEKIRDAG/Turkey
Brand Name +Dosage Form + Blumet I.V Solution for injection 50 mg/ 5ml
Strength
Composition Each 1 ml solution contain
Methylene Blue…. 10 mg
Finished Product Specification In-house
Pharmacological Group Antidotes; Other diagnostic agents
Shelf life 36 Months
Demanded Price NA

Pack size 5 ml glass ampoule of Type 1
International availability NA
Me-too status NA
Detail of certificates attached COPP (Original, Embassy Attested)
Certificate No:2018/15g6
Certifying Authority: Ministry of health Turkish medicine
and medical devise agency
Valid Date:25-4-2020
Letter of Authorization (original)
Date of Agreement:7-06-2018 (Valid for 5 year)
Free sale (Original, Embassy Attested)
Certificate No:2018/1581
Remarks of the Evaluator VII • Stability is at 45°C ± 2°C / 75% ± 5% RH (6
months) and 30°C ± 2°C / 65% ± 5% RH (6 months)
for 3 batches is provided. (Stability starting date:
11-7-2016)
• Evidence of approval of applied formulation in
reference regulatory authorities not available.
PROVAYBLUE 5 mg/ ml (50 mg/ 10 ml)
(USFDA) is in different strength and provided label
of 10 mg/ml itself claimed this drug is not found to
be effective and safe by USFDA and this label is not
approved by FDA.
Decision 288:
 Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were adopted by the Registration Board in its 275th meeting
 Long term Stability study covering the shelf life of applied product under the conditions of
zone IV-A.
Remarks of evaluator VII:
 Firm has provided Stability study Real time: 30°C ± 2°C / 75% ± 5% RH for 48 months
Accelerated: 40°C ± 2°C / 75% ± 5% RH for 6 months
S. NO Remarks Response
1. Evidence of approval of applied formulation Reference of MHRA is
in RRA is not valid as reference of provided again but it can not
Cambodia, Korea and Vietnam was provided be confirmed from the
by the firm. official site
• Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting and
DSL status as expired on 7th April 2020.
Name and address of manufacturer Vem ilac San. Ve Tic. A.S.
Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mah. Fatih Blv. No 38 Kapakli/TEKIRDAG/Turkey

Name and address of marketing Vem ilac San. Ve Tic. A.S.
authorization holder Address: Cerkezkoy organize Sanayi Bolgsi, Karaagac
Mahallesi. Fatih Bulvari. No 38
Kapakli/TEKIRDAG/Turkey
Brand Name +Dosage Form + Fuxesin 100 mg injection
Strength
Anidulafungin…. 100 mg
(Lyophilized powder for solution for infusion)
Shelf life 24 Months (2-8 ºC)
Pack size 20 ml, 50 ml, 100 ml Clear glass vial Type-I
International availability Ecalta 100 milligram(s) Powder and solvent for solution
for infusion Pfizer Europe (MHRA)
Me-too status NA
Detail of certificates attached COPP (Original, Embassy Attested)
Letter of Authorization (Original)
Date of Agreement:1-01-2016 (Valid for 5 year)
Free sale (Original, Embassy Attested)
Remarks of the Evaluator VII  Stability is at 5°C ± 3°C (24 months) and 25°C ±
2°C / 60% ± 5% RH (for 3 batches)
• Innovator, ERAXIS for Injection un reconstituted
vials and companion diluent vials should be stored
at 2-8ºC; Excursions for 96 hours up to 25°C are
permitted
Decision of 288:
1. Clarification regarding diluent for reconstitution of product
2. Clarification of applied dosage form whether lyophilized powder or lyophilized cake in
comparison to Innovator product approved by Reference Regulatory Authorities.
Remarks of evaluator VII:
The dosage form is lyophilized powder for injection the diluent is water for injection to provide
concentration of 3.33mg/ml.
Decision: Deferred for confirmation of status of DSL status as expired on 7th April 2020.
Name and address of manufacturer M/s Philinter pharma Co; Ltd, No 25, street# 8, VSIP,
Thuan An, Binh Duong 824060, Vietnam

Name and address of marketing M/s Phil inter pharma Co; Ltd, No 25, street# 8, VSIP,
authorization holder Thuan An, Binh Duong 824060, Vietnam
Brand Name +Dosage Form + Colvagl Soft gel Capsule (Vaginal inserts)
Strength
Nystatin…200,000IU
Nifuratel…500mg
Finished Product Specification Manufacturere
Pharmacological Group Gynecological anti-infective and antiseptic
Demanded Price Decontrolled
Pack size 100 g, 500 g, 1000g
International availability Inimur Complex by Polichem Sr (AIFA, Itley)
Me-too status NA
Detail of certificates attached Certificate of pharmaceutical products Copy embassy
attested (COPP):
Certificate No: 110241Gp-QLO
Certifying Authority: Ministry of health vietnam
Date of Review: June 12-2019
GMP certificate (Copy, Notary Attested, Embassy attested)
Certificate No:24g/GCNQLD
Certifying Authority: Ministry of health Vietnam
Issue Date: 14-6-2016
Remarks of the Evaluator VII.
S. Remarks Response
NO
1. A DSL copy in the name The application
of M/s B.M Biotech, 73-B, receipt for valid
Guldasht town, Zarrar licence is
shaheed road, Lahore cant, attached
Pakistan Validity: 7-
April-2020 was provided
which is not valid now and
the name is written as BM
biotech instead of Bristol
Myer Biotec
2. Evidence of approval of Inimur Complex
applied formulation in By Polichem Srl
RRA is not valid as "500 Mg +
reference of Cambodia, 200000 Iu Soft
Korea and Vietnam was Vaginal
provided by the firm. Capsules (Itley
approved)
3. Original legalized and Provided
Valid COPP needed.
Decision: Deferred for clarification of DSL details since Form-5A is from M/s Bristol Mayer
Biotech whereas renewal application submitted is for M/s. B.M Biotech.
1281. Name and address of Applicant M/s Premier Agencies. 1A/15, Sector 15, Korangi
Industrial Area, Karachi, Pakistan

Detail of Drug Sale License Address: M/s Premier Agencies. (godown) Plot No. D-3,
D-4 and D5 sector 6-F, Mehran town Karachi, Pakistan
Validity: 14-May-2020
Status: Drug License by Way of wholesale
Name and address of manufacturer M/s GE Healthcare Ireland Limited.
I.D.A. Business Park, Carrigtohill, Co. Cork, Ireland
Name and address of product license GE healthcare AS PO box 4220 Nydalen, NO-0401 Oslo
holder Norway
Name of exporting country Ireland
Fee including differential fee Rs. 100,000/- (Challan # 0702603) Dated 16-Jan-2018
Brand Name +Dosage Form + Omnipaque 350mg/ml Injection
Strength
Composition Each 1 ml of omnipaque solution for injection Contains
775 mg and 200 ml of solution contains Iohexol …151g
(Calculated on anhydrous base)
Pharmacological Group X-ray contrast media (Iodinated)
Demanded Price As per PRC
Pack size As per PRC, Polypropylene bottle (200 ml)
International availability Omnipaque 350 (USFDA)
Me-too status Iobrix of Hoffman Health Pakistan Ltd (Reg# 032124)
Detail of certificates attached Certificate of pharmaceutical products (Original, embassy
attested (COPP):
Certifying Authority: HPRA Health product regulatory
authority Kevin O Malley house, Earlsfort center, Earlsfort
terrace Dublin 2, Ireland
Date of issue: 29-April 2019
Letter of authorization (Original, Notary Attested, Embassy
attested)
Issue Date: 16 May 2019
Certificate of GMP (Copy embassy attested:
Certifying Authority: Health products regulatory authority
HPRA
Dated: 19 August 2016
Remarks of the Evaluator VII. In USP Iohexol injection is present.
The address of importer in Authority letter and Form
Pakistan is not as per 5-A with address of
provided DSL, in form 5- importer which is in line
A and letter of with DSL is provided
authorization, submit
form 5-A and letter of
authorization with correct
address which should be
in-lined with DSL.
As per explanatory note The filled volume is 200
provided with COPP, The ml for injection
fill volume of 200 ml
bottle is either 150, 175 ml
or 200 ml
Clarification is needed
regarding your filled
volume in 200 ml bottle.

Clarification is needed Firm clarify that the
regarding the batch stability according to zone
release site whether the IV-A is done by GE
stability according to zone healthcare Ireland
IVA is done in Ireland Limited.
(manufacturing site as per
COPP) or in china

1282. Name and address of Applicant M/s Premier Agencies. 1A/15, Sector 15, Korangi
Industrial Area, Karachi, Pakistan
Detail of Drug Sale License Address: M/s Premier Agencies. (godown) Plot No. D-3,
D-4 and D5 sector 6-F, Mehran town Karachi, Pakistan
Validity: 14-May-2020
Status: Drug License by Way of wholesale
Name and address of manufacturer M/s GE Healthcare Ireland Limited.
I.D.A. Business Park, Carrigtohill, Co. Cork, Ireland
Name and address of marketing GE healthcare AS PO box 4220 Nydalen, NO-0401 Oslo
authorization holder Norway
Fee including differential fee Rs. 100,000/- (Challan # 0702602) Dated 16-Jan-2018
Brand Name +Dosage Form + Visipaque 320mg/ml Injection
Strength
Composition Each 1 ml of Visipaque solution for injection contains 652
mg and 50 ml of solution contains 32.6g, 75 ml contains
48.9g and 100 ml contain 65.2 g of Iodixanol (Calculated
on anhydrous base)
Pharmacological Group X-ray contrast media
Pack size As per PRC, Polypropylene bottle (100 ml)
International availability Visipaque 320 (USFDA)
Me-too status Visipaque of Meximp Technologies (043052)
Detail of certificates attached Certificate of pharmaceutical products (Original, embassy
attested (COPP):
Certifying Authority: HPRA Health product regulatory
authority Kevin O Malley house, Earlsfort center, Earlsfort
terrace Dublin 2, Ireland
Date of issue: 29-April 2019
Letter of authorization (Original, Notary Attested, Embassy
attested)
Issue Date: 16 May 2019
Certificate of GMP (Copy embassy attested:
Certifying Authority: Health products regulatory authority
HPRA
Dated: 19 August 2016

The address of importer in Authority letter and Form

Pakistan is not as per 5-A with address of
provided DSL, in form 5- importer which is in line
A and letter of with DSL is provided
authorization, submit
form 5-A and letter of
authorization with correct
address which should be
in-lined with DSL.
As per explanatory note The filled volume is 100

provided with COPP, The ml for injection
fill volume of 100 ml
bottle is either 75 ml or
100 ml
Clarification is needed
regarding your filled
volume in 100 ml bottle.
Clarification is needed Firm clarify that the

regarding the batch stability according to zone
release site whether the IV-A is done by GE
stability according to zone healthcare Ireland
IVA is done in Ireland Limited.
(manufacturing site as per
COPP) or in china
Brand Name +Dosage Form + Philvolte Cream
Strength
Composition Each 10g tube contains:
Clotrimazole…100mg
Betamethasone dipropionate…6.4mg
Gentamicin sulfate…10mg
Pharmacological Group Topical anti-infective and corticosteroid
Pack size 10g
International availability NA (Triderm ® crème: 1 g cream contains:
Betamethasonum 0.5 mg, Clotrimazolum 10 mg,
Gentamicinum 1 mg)
Me-too status NA
attested (COPP):
Certificate No: 110241Gp-QLO
Date of review: June 12-2019
GMP status confirmed on COPP


of M/s B.M Biotech, 73- receipt for valid
B, Guldasht town, Zarrar licence is attached
shaheed road, Lahore
cant, Pakistan Validity:
7-April-2020 was
provided which is not
valid now and the name
is written as BM biotech
instead of Bristol Myer
Biotec
2. Evidence of approval ofFirm provide the
applied formulation in evidence of RRA in
RRA is not valid as swiss medics as
reference of Cambodia, Triderm ® crème in
Korea and Vietnam was which 1 g cream
provided by the firm. contains:
Betamethasonum
0.5 mg,
Clotrimazolum 10
mg, Gentamicinum
1 mg) but apllied
product has 6.4 mg
of betamethasone
3. Original legalized and Original legalized
Valid COPP needed. COPP is provided

Brand Name +Dosage Form + Gentrikin cream
Strength
Composition Each 10gm Tube Contains:
Econazole Nitrate…100mg
Triamcinolone acetonide…10mg
Gentamicin Sulfate…10mg
Pharmacological Group Topical anti-infective and corticosteroid
Pack size 10g
International availability NA
Me-too status NA
attested (COPP):
Certificate No: 1025/GP-QLD
Date of validitity: June 12-2019

B, Guldasht town, Zarrar licence is
shaheed road, Lahore attached
cant, Pakistan Validity:
7-April-2020 was
provided which is not
valid now and the name
is written as BM biotech
instead of Bristol Myer
Biotec
2. Evidence of approval of Firm provide
applied formulation in the evidence in
RRA is not valid as Mayanmar as it
reference of Cambodia, is not present in
Korea and Vietnam was RRA
provided by the firm.
3. Original legalized and Original
Valid COPP needed. legalized COPP
is provided
4. Orignal authority letter Provided
5. Stability protocols Provided
Thuan An, Binh Duong, Vietnam
Fee including differential fee Rs. 50,000/- (#0702406) Dated 28-12-2017
Brand Name +Dosage Form + Vagicare soft gel capsule
Strength
Composition Each soft gel capsule Contains:
Promestriene…….…. 10 mg
Pharmacological Group Estrogens
Pack size 10g
International availability Gynogyne 10 mg, vaginal soft capsule (ANSM France)
Me-too status NA
attested (COPP):
Certificate No: 1021/GP-QLD
Date of review: 10 sep 2018
GMP is confirmed from COPP
Sr. Remarks Response
No.
B, Guldasht town, Zarrar licence is
shaheed road, Lahore attached.
cantt, Pakistan.
Validity: 7-April-2020
was provided which is
not valid now and the
name is written as BM
biotech instead of Bristol
Myer Biotec
2. Evidence of approval of Reference of
applied formulation in Gynogyne 10
RRA is not valid as mg, vaginal soft
reference of Cambodia, capsule (ANSM
Korea and Vietnam was France) was
provided by the firm. provided.
3. Original legalized and Original
Valid COPP needed. legalized COPP
is provided
4. Original authority letter Provided
5. Stability protocols Provided

Submission of stability study data as per Zone IVA.
Clarification of DSL details since Form-5A is from M/s Bristol Mayer Biotech whereas renewal
application submitted is for M/s. B.M Biotech.
Case No. 6 Miscellaneous cases

1286. Name and address of manufacturer / M/s The Searle Company Limited.
Applicant 1st Floor, N.I.C.L Building, Abbasi Shaheed
Road, Shahrah-e-Faisal, Karachi
Brand Name +Dosage Form + Strength Xadine 30mg/5ml Suspension
Diary No. Date of R& I & fee Form-5 Dy.No 2687 dated 21-01-2019
Rs.20,000/- Dated 18-01-2019 (#0799839)
Form Form-5
As per SRO
Approval status of product in Reference TELFAST ORAL LIQUID fexofenadine
Regulatory Authorities hydrochloride 6 mg/mL oral suspension bottle.
TGA approved
Me-too status Telfast Suspension by M/s Sanofi Aventis
(Reg. # 058699)
GMP status Last GMP inspection report dated 13-2-2018:
Follow-up, as per the data provided by QALT
Division.
Decision 295:
Approved with innovator’s specification
Remarks:
In the meeting of 295 the address of manufacturer of the above case was mentioned as M/s The
Searle Company Limited. 1st Floor, N.I.C.L Building, Abbasi Shaheed Road, Shahrah-e-Faisal,
Karachi (Head quarter address) but the correct Factory address as per Form 5 was M/s The Searle
Company Limited.32 km multan road, Lahore.
Decision: Approved with change in address from M/s The Searle Company Limited. 1st
Floor, N.I.C.L Building, Abbasi Shaheed Road, Shahrah-e-Faisal, Karachi (Head quarter
address) to M/s The Searle Company Limited.32 km Multan road, Lahore.
Evaluator-PEC-VIII
Item No. I: Agenda of Evaluator PEC-VIII
b. Deferred cases
1286. Name and address of manufacturer / "M/s Scotmann Pharmaceuticals. 5-D, I-10/3, Industrial Area,
Applicant Islamabad"
Brand Name +Dosage Form + Strength Pizo 0.5mg Tablet

Composition "Each Sugar-Coated Tablet Contains:
Pizotifen (as maleate) …0.5mg"
Diary No. Date of R& I & fee Dy. No. 37116/4 dated 09-11-2018 Rs.20,000/-
Pharmacological Group Antimigraine)
Type of Form Form-5
Finished product Specifications JP Specifications (not found)
Approval status of product in Approved in MHRA
Me-too status (with strength and Mosegor 0.5mg sugar coated tablet of M/s Novartis
dosage form)
GMP status Dated: 10-10-2018 & 17-10-2018
Recommendations:
Firm has been adhering to GMP guidelines and showing good
compliance with quality policy completely implemented.
Guidelines, SOP‟s and written instructions for each and every
step in manufacturing testing, and storage ensuring quality
products are intact and implemented. Keeping in view the
above, the panel unanimously recommends for grant of GMP
certificate.
Remarks of the Evaluator VIII Evidence of approval of applied formulation as sugar coated
tablet in reference regulatory authorities/agencies which were
meeting & also submit master formulation &manufacturing in
line with reference product.
Decision 295: Deferred for evidence of approval of applied formulation as sugar coated tablet in reference
regulatory authorities/agencies which were declared/approved by the Registration Board in its 275th
meeting & also submit master formulation & manufacturing in line with reference product.
Remarks VIII:
Firm provided the reference of Sandomigran (Pizotifen Malate) Tablet sugar coated approved in TGA
Australia.
Decision: Approved
1287. Name and address of manufacturer / "M/s Welwrd Pharmaceuticals. Plot # 3, Block A, Phase I-II,
Applicant Industrial Estate Hattar, KPK"
Brand Name +Dosage Form + Strength Welfax SR 50mg Tablet
Composition "Each Extended Release Film Coated Tablet Contains:
Desvenlafaxine (as Succinate)…50mg"
Diary No. Date of R& I & fee Dy. No. 21237 dated 13-06-2018 Rs.20,000/- 12-06-2018
Pharmacological Group Antidepressants
Type of Form Form-5
Finished product Specifications As per innovator
Approval status of product in Approved USFDA
Me-too status (with strength and Qrist 50mg Tablet of Nabiqasim Karachi.
dosage form)
GMP status GMP Inspection conducted on 14-07-2017 concluded that the
firm is GMP compliant over all.
Remarks of the Evaluator VIII Applied formulation is extended release tablet; name the
extended release polymers as it is not present in master
formulation. Firm has submitted a master formulation having
extended release polymer Incorporated into core & coat of
tablet.
Decision 295: Deferred for clarification/justification regarding addition of extended release polymer in
core & coat of tablet or else submission of master formulation & manufacturing method in-line with
innovator.
Remarks VIII:
Copy of revised master formulation and method of manufacturing provided for extended release film
coated tablet was provided with fee of 20,000/- (#2028798) dated 7 July 2020
1288. Name and address of manufacturer / "M/s Pearl Pharmaceuticals. Plot No. 204, Street No.1, I-10/3,
Brand Name +Dosage Form + Strength Terbipearl 1% Cream
Composition "Each Gram Contains:

Terbinafine as HCL…1% w/w"
Diary No. Date of R& I & fee Dy. No. 38920 dated 27-11-2018 Rs.20,000/-
Pharmacological Group Anti-Fungal
Type of Form Form-5
Finished product Specifications Innovator’s Specifications
Approval status of product in Approved in US-FDA
Me-too status (with strength and Exinofin Cream of Brookes Pharmaceuticals, Karachi
dosage form)
GMP status GMP inspection conducted on 23-07-2018 concluded that firm
is operating at fair level of GMP compliance.
Remarks of the Evaluator (VIII) Reference product is approved as Terbinafine hydrochloride
1.0% w/w cream which is different from applied formulation i.e.
Terbinafine as HCL 1% w/w"& also submit label claim of
applied formulation in line with innovator product.
Mention primary packaging material for applied formulation.
Decision 295: Deferred for the following:
Reference product is approved as Terbinafine hydrochloride 1.0% w/w cream which is different from
applied formulation i.e. Terbinafine as HCL 1% w/w"& also submit label claim of applied formulation in
line with innovator product.
Mention primary packaging material for applied formulation.
Remarks VIII:
GMP dated 23-7-2018with satisfactory GMP compliance.
Firm responded that each gram of terbipearl 1% cream contain 10 mg terbinafine HCL which is in line
with Lamisil 1% cream an DA approved product of Novartis USA.
Copy of relevant pages of Form 5 were provided too.
Primary packaging is collapsible aluminum tubes.
1289. Name and address of manufacturer / "M/s Pearl Pharmaceuticals. Plot No. 204, Street No.1, I-10/3,
Brand Name +Dosage Form + Strength Linzopearl 100mg/5ml Oral Suspension
Composition "Each 5ml Contains:

Linezolid…100mg"
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications
Pack size & Demanded Price (60ml): As per SRO
Approval status of product in Approved in MHRA
Me-too status (with strength and Linzol 100mg /5ml oral dry suspension of M/s Regal
dosage form) Pharmaceuticals
GMP status GMP inspection conducted on 23-07-2018 concluded that firm
is operating at fair level of GMP compliance.
Remarks of the Evaluator (VIII) Mention type of primary packaging material of applied
formulation.
Mention polymeric form of Linezolid
Decision of 295: Deferred for the following:
Mention type of primary packaging material of applied formulation.
Mention polymeric form of Linezolid.
Remarks VIII:
GMP dated 23-7-2018with satisfactory GMP compliance
Amber color glass bottle of 120 ml
Case No. 02 Registration applications for local manufacturing of (veterinary) drugs

b. Deferred Cases
Brand Name +Dosage Form + Strength Floron Oral Powder
Neomycin Sulphate ….….....150 mg
Florfenicol……………………100 mg
Oxytetracycline hydrochloride….…300 mg
Diary No. Date of R& I & fee Dy. No. 21143 dated 18-10-2019 Rs. 20,000
Pharmacological Group Aminoglycoside/Antibiotic
Type of Form Form-5
Pack size & Demanded Price 0.5kg, 1kg, 2.5kg, 5kg; Decontrolled
Me-too status (with strength and dosage E.Col Oral Powder of Evergreen Pharma Registrtion No.
form) 081733 (not verifiable)
GMP status Oral Liquid section (general)(veterinary)Letter Issuance Date:
26th September, 2019. On recommendation of panel of experts
CLB in its 271st meeting held on 12th September, 2019 has
considered & approved following six additional section of M/s.
Grand Pharma:
1. Bolus section (general)(veterinary)
2. Oral Powder section (general)(veterinary)
3. Oral Liquid section (general)(veterinary)
4. Oral Powder section (penicillin)(veterinary)
5. Dry Powder Injection section Vials (penicillin)(veterinary)
6. Liquid Injection section Vials (penicillin)(veterinary)
Remarks of the Evaluator VIII Evidence of applied formulation/drug already approved by
brand name and name of firm, as the provided evidence is not
verifiable.
Decision 295: Deferred for evidence of applied formulation/drug already approved by DRAP (generic /
me-too status) alongwith registration number, brand name and name of firm.
Remarks VIII: Me-too of E.Col Oral Powder of Evergreen Pharma Registrtion No. 081733 was provided
by the firm.
Brand Name +Dosage Form + Strength Enro-Hexin Oral Liquid Suspension

Enrofloxacin…10gm
Bromhexine Hcl…1gm
Colistin Sulphate…55 MIU"

Diary No. Date of R& I & fee Dy.No 21156 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic / Expectorant
Type of Form Form-5
Pack size & Demanded Price 100ml, 500ml, 1liter; Decontrolled
Me-too status (with strength and dosage En-C-Raft Oral Liquid of NAWAL PHARMA (Reg# 078251)
form) (not verifiable)
Grand Pharma:
5. Dry Powder Injection Section Vials (penicillin)(veterinary)
verifiable.
me-too status) along with registration number, brand name and name of firm.
Remarks VIII:
Firm revised their master formulation and form 5 with formulation of
"Each 100ml Contains:
Enrofloxacin…10gm
Bromhexine Hcl…0.5 mg
Me too: En-C-Raft Oral Liquid of NAWAL PHARMA (Reg# 078251)
(Firm claim to submit fee of 5000/- but no fee challan was attached)
product
Brand Name +Dosage Form + Strength G-Flor Plus Oral Liquid

Florfenicol…23gm
Diary No. Date of R& I & fee Dy.No 21148 dated 18-10-2019 Rs. 20,000
Pharmacological Group Antibiotic / Expectorant
Type of Form Form-5
Pack size & Demanded Price 500ml, 1liter, 2.5liter, 5liter; Decontrolled
Me-too status (with strength and dosage NA
form) Maxiflor Plus Oral Liquid of BIOGEN Pharma (Reg# 075617).
Each 1000ml Contains: -
Florfenicol…………23gm

Colistin Sulphate...50 MIU
Grand Pharma:
5. Dry Powder Injection Section Vials (penicillin)(veterinary)
verifiable.
Remarks VIII: The provided reference of Fenicol 23 oral liquid (# 0080731) of Baariq Pharma can’t be
verified.
Brand Name +Dosage Form + Strength Doxy-Hy 50 Oral Powder
Composition Each kg contains:

Doxycycline Hyclate (BP)…………500 gm
Diary No. Date of R& I & fee Dy. No. 21140 dated 18-10-2019 Rs. 20,000
Type of Form Form-5
Finished product Specifications Manufacturer's specification
Pack size & Demanded Price 0.5kg, 1kg, 2.5kg, 5kg; Decontrolled
Me-too status (with strength and dosage Doxyvetz Oral Powder of M/s Vetz Pharma Reg. No.088059
form) (not verifiable)
GMP status Date: 26th September, 2019. On recommendation of panel of
experts CLB in its 271st meeting held on 12th September, 2019
has considered & approved following six additional section of
M/s. Grand Pharma:
5. Dry Powder Injection section Vials (penicillin)(veterinary)
verifiable.
Decision (M-294): Deferred for evidence of applied formulation/drug already approved by DRAP (generic
Remarks of the Evaluator VIII
Now the Applicant has Submitted Evidence of following Me Too:
Seldox Powder of Selmore Pharmaceuticals

Each G Contains: -
Doxycycline Hyclate…..500mg.
*applied formulation is in kg but me too product is in grams.
Decision 295: Deferred for either evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm or otherwise
revision of formulation in line with provided Me Too alongwith submission of requisite fee as the
provided evidence is in gram while applied formulation contains same quanity of ingredient per kg.
Remarks VIII: The firm submitted that “the same formulation Se-Dox 50 (Each kg contains:
Doxycycline Hyclate (BP)……..………500 gm) with same reference of Seldox Powder of Selmore
Pharmaceuticals (Each g contains: Doxycycline Hyclate (BP)……..………500 mg) is approved in 291
meeting of DRB for vetec lab so kindly carry forward our case too”
1294. Deleted
1295. Deleted
1296. Name and address of manufacturer / "M/s Elegance Pharmaceuticals.

Applicant Chak Belli Pandori Road, Distt. Rawalpindi"
Brand Name +Dosage Form + Strength Amantacin 10gm Powder
Composition Each 100gm Contains:
Amantadine HCL…10gm
Pharmacological Group Anti-viral
Type of Form Form-5
Pack size & Demanded Price Decontrolled
Me-too status (with strength and dosage
form)
Me-too status (with strength and dosage Could not be confirmed
form)
GMP status ---
Remarks of the Evaluator (VIII) Evidence of applied formulation/drug already approved by
brand name and name of firm, as the provided Me Too is not
verifiable.
Approval of section/manufacturing facility by the Central
facility.
Submit latest GMP inspection report.
Decision of 295: Deferred for the following:
registration number, brand name and name of firm, as the provided Me Too is not verifiable.
Approval of section/manufacturing facility by the Central Licensing Board.
Latest GMP inspection report.
Remarks VIII:
Remarks Firm response
Submit latest GMP inspection report. GMP dated 5th Oct 2019 with GMP compliant
Approval of section/manufacturing Letter from licensing division for oral liquid
facility by the Central Licensing Board. syrup (Veterinary) and for oral dry powder
However, you may submit panel (Veterinary)
inspection report for renewal of DML
verifying the section/manufacturing
facility.

Evidence of applied formulation/drug Amantabak 10% powder by M/S Attabak
already approved by DRAP (generic / pharma
me-too status) alongwith registration (# 075697)
number, brand name and name of firm,
as the provided Me Too is not
verifiable.
1297. Name and address of manufacturer / "M/s Elegance Pharmaceuticals. Chak Belli Pandori Road,
Applicant Distt. Rawalpindi"
Brand Name +Dosage Form + Strength NFO Powder

Florfenicol…100gm
Oxytetracycline HCL…300gm
Neomycin Sulphate…150gm
Type of Form Form-5
Pack size & Demanded Price decontrolled
form)
GMP status ----
verifiable.
Decision of 295:
Deferred for the following:
Approval of section/manufacturing facility by the Central Licensing Board. However, you may submit
panel inspection report for renewal of DML verifying the section/manufacturing facility.
facility.
Evidence of applied formulation/drug Firm modified there composition from
already approved by DRAP (generic / Each 1000gm Contains:
me-too status) alongwith registration Florfenicol…100gm
number, brand name and name of firm, Oxytetracycline HCL…300gm
as the provided Me Too is not Neomycin Sulphate…150gm
verifiable. as
Each gm Contains:
Florfenicol…100 mg
Oxytetracycline HCL…300 mg
Neomycin Sulphate…150 mg
Me too: Amantabak 10% powderZ-florcin wsp
by M/S Zoic international
(# 090680)
With fee of 5000/- (#1953374) dated 13-8-2020
Brand Name +Dosage Form + Strength Interflor 250mg/ml Liquid

Florfenicol…250mg
Diary No. Date of R& I & fee Dy.No 34439 dated 17-10-2018 Rs.20,000/- Dated 16-10-
2018
Pharmacological Group antibiotic
Type of Form Form-5
form)
GMP status -----
verifiable.
Decision of 295:
facility.
Evidence of applied formulation/drug FLORFENICOL ORAL LIQUID by M/S
already approved by DRAP (generic / Attaback Pharma
me-too status) alongwith registration (# 075707)
number, brand name and name of firm,
as the provided Me Too is not
verifiable.
Brand Name +Dosage Form + Strength Doxyl-80 Powders

Doxycycline Hyclate 918.23mg Eq. to Doxycycline
Base…800mg
Diary No. Date of R& I & fee Dy. No. 34441 dated 17-10-2018 Rs.20,000/- Dated 16-10-
2018
Type of Form Form-5
form)
GMP status ----
Remarks of the Evaluator (VIII)
Decision of 295:
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along with
Submit latest GMP inspection report. GMP dated 5th Oct 2019 with GMP
compliant
facility.
Evidence of applied formulation/drug Doxyral 80% Water Soluble Powder For Oral
already approved by DRAP (generic / ROUTE by M/S Orient
me-too status) alongwith registration (#'082504)
number, brand name and name of firm, Each Gram of Water-Soluble Powder
as the provided Me Too is not Contains: -
verifiable. Doxycycline Hyclate…...923.32mg
(Eq. To 800mg Doxycycline)
1300. Name and address of manufacturer / "M/s Elegance Pharmaceuticals.

Applicant Chak Belli Pandori Road, Distt. Rawalpindi"
Brand Name +Dosage Form + Strength Encopol Liquid
Enrofloxacin…20%
Colistin Sulphate…3%
Type of Form Form-5
form)
GMP status ----
Remarks of the Evaluator (VIII) Please clarify the following: Enrofloxacin… 20%/ml &
Colistin Sulphate…3%"/ml. what does it mean?
Approval of section/manufacturing facility by the Central
facility

Decision of 295:
Please clarify the following: Enrofloxacin… 20%/ml & Colistin Sulphate…3%"/ml. what does it mean?
panel inspection report for renewal of DML verifying the section/manufacturing facility
Submit latest GMP inspection report. GMP dated 5th Oct 2019 with GMP
compliant
facility.
already approved by DRAP (generic / Each ml Contains:
me-too status) alongwith registration Enrofloxacin…20%
number, brand name and name of firm, Colistin Sulphate…3%
as the provided Me Too is not as
verifiable. Each 100 ml Contains:
Enrofloxacin…20%
Colistin Sulphate…3%
Me too: ENROSIR-20 ORAL LIQUID by
M/S ATTABAK PHARMA (# 090680)
With fee of 5000/- (#1953375) dated 13-8-
2020
1301. Name and address of manufacturer/ M/s Elegance Pharmaceuticals. Chak Belli Pandori Road, Distt.
Applicant Rawalpindi
Brand Name + Dosage Form + Strength Enro Ts Liquid

Enrofloxacin…75mg
Sulphamethoxy Pyridazine…75mg
Sulphamethazine…50mg
Trimethoprim…25mg
PKR. 20,000/-; 28.02.2019
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1L; Decontrolled
Me-too status CINA T.S ORAL SUSPENSION. Reg. NO. 31456
(enroflodicaine has been mentioned instead of enrofloxacin).
GMP status The firm was inspected on 29.11.2018 and 04.05.2019 with the
following conclusion: The observation mostly been complied
& working good level of GMP as of today.
Remarks of the Evaluator The firm mentioned Sulphamethoxy Pyridazine in the label
claim and Sulphamethoxy Pyridazine as sodium in the master
formula and manufacturing outlines. Upon justification the firm
revised the master formula.

Decision of 295:
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along with
facility.
Evidence of applied formulation/drug Cina T.S Oral Suspension By Leads (#031456)
already approved by DRAP (generic / (Each ml Contains:-
me-too status) alongwith registration Trimethorpim 25mg.
number, brand name and name of firm, Sulphamethazine 50mg.
as the provided Me Too is not Sulphamethoxyparadazine 75mg.
verifiable. Enroflodacine (Cenoxine) 75mg)
Brand Name + Dosage Form + Strength Doc Powder
Composition Each 100gm contains:

Doxycycline HCL…20gm
Colistin sulphate…40,000,000IU
Carrier q.s.…100gm
PKR. 20,000/-; 28.02.2019
Type of Form Form 5
Pack size & Demanded Price 100g, 500g, 1kg; Decontrolled
Me-too status DOXYCOL DS ORAL POWDER. Reg. no. 31482
Remarks of the Evaluator The firm has mentioned the carrier in the label claim. Upon
clarification the firm submitted they have applied as per label
of me-too product available in the market.
Decision of 295:
Deferred for clarification of carrier in the applied formulation.
facility.
already approved by DRAP (generic / Each 100gm contains:
me-too status) alongwith registrationDoxycycline HCL…20gm
number, brand name and name of firm, Colistin sulphate…40,000,000IU
as the provided Me Too is not Carrier q.s.…100gm
verifiable. as
Each 100gm contains:
Colistin sulphate…40,000,000IU
Me too: DOXYCOL DS ORAL POWDER.
by M/S Bio Lab
(#'031482)
With fee of 5000/- (#1953376) dated 13-8-2020
Brand Name + Dosage Form + Strength E Linco Powder
Composition Each 100-gm powder contain

Lincomycin HCl…4.4%
PKR. 20,000/-; 28.02.2019
Pharmacological Group Lincosamide
Type of Form Form 5
Me-too status LINCOS-P POWDER. Reg. No. 49667
Remarks of the Evaluator The firm was asked to clarify Lincomycin HCl…4.4%. The
firm submitted they have applied as per label of me-too product
available in the market.
Decision of 295:
Deferred for correction in the label claim of applied formulation.
Evidence of applied formulation/drug Firm modified their composition from
already approved by DRAP (generic / Lincomycin HCl…4.4%
me-too status) alongwith registration as
number, brand name and name of firm, Each 100 gm powder contain
as the provided Me Too is not verifiable. Lincomycin HCl…4.4%
Me too: Lincos-P powder. by M/S Inshal
pharma (#'093601)
With fee of 5000/- (#1953377) dated 13-8-
2020
Brand Name + Dosage Form + Strength Elecox Powder

Amprolium HCL…30gm
Sulphaquinoxalin sodium…20gm
Vitamin K3…600mg
PKR. 20,000/-; 28.02.2019
Pharmacological Group Treatment of coccidiosis + vitamin K
Type of Form Form 5
Me-too status DYECOX WATER SOLUBLE POWDER. Reg. No. 74064
Remarks of the Evaluator The firm was asked to revise the strength of APIs in line with
the me-too product along with submission of applicable fee.
The firm submitted they have applied as per label of me-too
product available in the market.
Decision of 295:
Evidence of applied formulation/drug Firm modified their formulation from
already approved by DRAP (generic / Each kg contains: -
me-too status) alongwith registration Sulphaquinoxaline (as sodium). 200gm.
number, brand name and name of firm Amprolium hcl. 300 gm.
Vitamin k3 6 g.
to
Each 100gm contains: -
Sulphaquinoxaline (as sodium) b.p. 20gm.
Amprolium hcl b.p. 30gm.
Vitamin k3 b.p. 600mg.
Me too: DYECOX ORAL POWDER. By Biogen
Pharma
by M/S Bio Lab
(#'031482)
With fee of 5000/- (#1953378) dated 13-8-2020
Brand Name + Dosage Form + Strength Norfim S Liquid

Norfloxacin…10gm
Sulphamethoxypyridazine sodium…15gm
Trimethoprim…30gm
PKR. 20,000/-; 28.02.2019
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1 L; Decontrolled
Me-too status NORTRIM-S ORAL LIQUID. Reg. No. 75779
Remarks of the Evaluator Revise the strength of APIs in line with the me-too product
along with submission of applicable fee.

Decision of 295:
Deferred for revision of formulation as per me-too reference.
Evidence of applied Firm modified their formulation from
formulation/drug already approved Each 100ml contains:
by DRAP (generic / me-too status) Norfloxacin…10gm
alongwith registration number, Sulphamethoxypyridazine sodium…15gm
brand name and name of firm Trimethoprim…30gm
to
Each 100ml contains:
Norfloxacin…10gm
Sulphamethoxypyridazine sodium…15gm
Trimethoprim…3 gm
Me too: Norplus Liquid By Biogen Pharma
by M/S Attaback Pharma
(#'034534)
With fee of 5000/- (#1953379) dated 13-8-
2020
Item No. I: Agenda of Evaluator PEC- XIII

a. New cases
1306. Name and address of manufacturer/ M/s Goodman Laboratories, Plot No. 5, Street No. S- 05,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name + Dosage Form + Strength E- Cit tablet 20mg
Escitalopram as oxalate………………………...…20mg
Diary No. Date of R & I & fee Dy. No. 10788 dated 05-03-2019 Rs.20,000/- Dated 04-03-
2019
Pharmacological Group Anti- depressant
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s & As per SRO
Me-too status Citanew 20mg tablet of M/s Hilton Pharma, Korangi Industrial
Area, Karachi (Reg. # 037681)
GMP status GMP certificate has been granted to the firm on the basis of
evaluation done on 08-08-2018.
Remarks of the EvaluatorXIII  General tablet section is available in the firm as
mentioned in the submitted GMP certificate.
Decision: Approved.
Brand Name + Dosage Form + Strength Levecetam tablet 250mg
Levetiracetam……………….250mg
Diary No. Date of R & I & fee Dy.No.9488 dated 01-03-2019 Rs.20,000/- Dated 28-02-2019
Pharmacological Group Anti- epileptic
Me-too status Leveticam 250mg tablet of M/s WnsFeild Pharma, Hattar (Reg.
# 084220)
Decision: Approved.
Brand Name + Dosage Form + Strength Levecetam tablet 500mg
Levetiracetam……………….500mg
Me-too status Leveticam 500mg tablet of M/s WnsFeild Pharma, Hattar (Reg.
# 084221)
Decision: Approved.
Brand Name + Dosage Form + Strength Pride tablet 100mg
Amisulpride………………………...100mg
Pharmacological Group Anti- psychotic
Me-too status Solium- 100 tablet of M/s Genome Pharmaceuticals (Pvt.) Ltd,
Hattar. (Reg. # 074533)
Decision: Approved.
Brand Name + Dosage Form + Strength Pride tablet 400mg
Composition Each film- coated tablet contains:
Amisulpride……………..400mg
Approval status of product in Reference MHRA Approved as uncoated tablet
Me-too status Amirid of M/s Shrooq Pharma, Lahore (Reg. # 063103)
 The applied formulation is approved as uncoated tablet
in MHRA.
Decision: Deferred for the clarification of manufacturing outline as in reference regulatory
authorities the approved drug is uncoated tablet, while the applied drug is film- coated tablet.
Brand Name + Dosage Form + Strength Modnil tablet 100mg
Modafinil…...100mg
Diary No. Date of R & I & fee Dy.No 10304 dated 05-03-2019 Rs.20,000/- Dated 04-03-2019
Pharmacological Group Psycho- stimulant
Me-too status V- Zac Tablet 100mg of M/s Wilshire Laboratories, Lahore
(Reg. # 055346)
Decision: Approved.
Brand Name + Dosage Form + Strength Modnil tablet 200mg
Modafinil…..200mg
Pharmacological Group Psycho- stimulant
Me-too status V- Zac Tablet 200mg of M/s Wilshire Laboratories, Lahore
(Reg. # 055347)
Remarks of the Evaluator XIII
 General tablet section is available in the firm as
Decision: Approved.
Brand Name + Dosage Form + Strength Topigen tablet 25mg
Topiramate…………….....25mg
Finished product Specification Manufacturers

Pack size & Demanded Price 30’s, 60’s & As per SRO
Me-too status Topirat tablets 25mg of M/s Gray’s Pharmaceuticals,
Islamabad (Reg. # 040867)
 The official monograph for the applied formulation is
available in USP.
Brand Name + Dosage Form + Strength Dil tablet 6.25mg
Carvedilol………………6.25mg
Pharmacological Group Anti- hypertensive
Pack size & Demanded Price 10’s, 20’s, 30’s, 50’s & As per SRO
Me-too status Carveda tablet of M/s Ferozesons Labs, Nowshera
(Reg. # 032569)
Decision: Approved.
Brand Name + Dosage Form + Strength Dil tablet 12.5mg
Carvedilol………………12.5mg
Me-too status Carveda tablet of M/s Ferozesons Labs, Nowshera
(Reg. # 056263)
Decision: Approved.
Brand Name + Dosage Form + Strength Amlustar tablet 5/80mg
Amlodipine besylate eq. to Amlodipine……………..5mg
Valsartan……………………………………………80mg
th
Pharmacological Group Angiotensin- II receptor blocker/ Calcium channel blocker
Pack size & Demanded Price 1x 14’s, 2x 14’s &As per SRO
Me-too status Exforge 5/ 80mg film- coated tablets of M/s Novartis Pharma
(Pakistan) Limited, Karachi (Reg. # 047569)
available in USP.
Brand Name + Dosage Form + Strength Amlustar tablet 5/ 160mg
Amlodipine besylate eq. to Amlodipine……………..5mg
Valsartan………………………………………..…160mg
Pack size & Demanded Price 1x 14’s, 2x 14’s & As per SRO
available in USP.
Brand Name + Dosage Form + Strength Amlustar tablet 10/ 320mg
Amlodipine besylate eq. to Amlodipine……..……..10mg
Valsartan………………………………………..…320mg
Me-too status Exforge 10/ 320mg film- coated tablets of M/s Novartis
Pharma (Pakistan) Limited, Karachi (Reg. # 069546)

available in USP.
Brand Name + Dosage Form + Strength Zolidin tablet 400mg
Linezolid…………………400mg
Pharmacological Group Anti- infective
Pack size & Demanded Price 10’s, 12’s, 14’s &As per SRO
Approval status of product in Reference ANSM; France Approved
Me-too status Linezert tablet of M/s Albert Pharmaceuticals, Lahore
(Reg. # 087558)
 The applied formulation is non- pharmacopoeial.
Decision: Approved with innovators’ specifications.
Brand Name + Dosage Form + Strength Zolidin tablet 600mg
Linezolid…………………600mg
Me-too status Linez 600mg Tablet of M/s Nexus Pharma (Pvt.)Ltd
Korangi Industrial Area, Karachi (Reg. # 061309)
Brand Name + Dosage Form + Strength Zolidin Suspension 100mg/5ml
Linezolid……………….100mg
Pack size & Demanded Price 60ml, 120ml & As per SRO

Me-too status Linez Dry 100mg/5ml Powder Suspension of M/s Nexus
Pharma Karachi (Reg. # 081594)
Remarks of the EvaluatorXIII  General oral dry powder for suspension section is
available in the firm as mentioned in the submitted GMP
certificate.
Brand Name + Dosage Form + Strength T- Sart Tablet 20mg
Telmisartan….20mg
Pharmacological Group Angiotensin- II Antagonist
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’ &As per SRO
Me-too status Telmas tablets of M/s Global Pharmaceuticals, Islamabad(Reg.
# 048333)
Decision: Approved.
Brand Name + Dosage Form + Strength T- Sart Tablet 80mg
Telmisartan….80mg
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’ & As per SRO
Me-too status Telmas tablets of M/s Global Pharmaceuticals, Islamabad
(Reg. # 048331)
Decision: Approved.
Brand Name + Dosage Form + Strength T- Sart Tablet Plus 40mg/ 12.5mg
Telmisartan…………………………………………40mg
Hydrochlorothiazide…………………………...…12.5mg
Pharmacological Group Angiotensin- II Antagonist/ Diuretics
th
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’, 50’s & As per SRO
Approval status of product in Reference USFDA Approved as bilayered tablet
Me-too status Co Telmas 40mg Tablets of M/s Global Pharmaceuticals,
Islamabad. 056285
 The applied drug is USFDA approved as bilayered
tablet.
Decision: Deferred for the following reasons:
 Clarification of manufacturing outline as in reference regulatory authorities the approved
drug is bilayered tablet, while the applied drug is mono layered tablet.
 Confirmation of required manufacturing equipment i.e. tablet bilayered machine by area
FID.
Brand Name + Dosage Form + Strength T- Sart Tablet Plus 80mg/ 12.5mg
Telmisartan…………………………………………80mg
Hydrochlorothiazide…………………………...…12.5mg
Pharmacological Group Angiotensin- II Antagonist/ Diuretics
Approval status of product in Reference USFDA Approved as bilayered tablet
Me-too status Co Telmas 80mg Tablets of M/s Global Pharmaceuticals,
Islamabad. 056286
 The applied drug is USFDA approved as bilayered
tablet.
Decision: Deferred for the following reasons:
drug is bilayered tablet, while the applied drug is mono layered tablet.
 Confirmation of required manufacturing equipment i.e. tablet bilayered machine by area
FID.
Brand Name + Dosage Form + Strength Lefmide Tablet 20mg
Leflunomide……………...20mg
Pharmacological Group Immuno- suppressant
Me-too status Lefluno Tablet of M/s Caraway Pharmaceuticals, Islamabad.
050063
th
Decision: Approved.
Brand Name + Dosage Form + Strength Losap Tablet 25mg
Losartan Potassium……....25mg
Me-too status Sartan Tablets of M/s Barrett Hodgson Pakistan (Pvt.) Ltd,
Karachi 024250
Decision: Approved.
Brand Name + Dosage Form + Strength Losap Tablet 50mg
Losartan Potassium……....50mg
Me-too status Losart 50mg Tablets of M/s Pearl Pharmaceuticals Islamabad
035650
Decision: Approved.
Brand Name + Dosage Form + Strength Coxib Tablet 60mg
Etoricoxib ………………..60mg
Pharmacological Group Anti- inflammatory/ Anti- rheumatic
Me-too status Etoricox 60mg Tablet of Kaizen Pharma Karachi 076226

Decision: Approved.
Brand Name + Dosage Form + Strength Tramol Plus Tablets 325mg/37.5mg
Paracetamol……………..325mg
Tramadol HCl………….37.5mg
Me-too status Ultragesic Tablet of Opal lab Karachi 076256
Decision: Approved.
Brand Name + Dosage Form + Strength Sitamet DS Tablet 50mg/1000mg
Sitagliptin as Phosphate Monohydrate……………..50mg
Metformin HCl…………………………………..1000mg
Pharmacological Group Anti- diabetic
Me-too status Sitaglu Met 50/ 1000 Tablet of Hilton Pharma (Pvt.) Limited
Karachi 055162
Decision: Approved.
Brand Name + Dosage Form + Strength Pin 0.25mg Tablet
Ropinirole as HCl….......0.25mg
Pharmacological Group Anti- Parkinson drug
Pack size & Demanded Price 10’s, 14’s, 20’s, 21’s, 28’s, 30’s, 50’s & As per SRO
Me-too status Ropinol 0.25mg Tablet of Amarant, Karachi 070779
th
Decision: Approved.
Brand Name + Dosage Form + Strength Pine 200mg Tablet
Quetiapine as fumarate…..200mg
Me-too status Qusel Tablet 200mg of M/s Hilton Pharma (Pvt.) Ltd, Karachi
037690
Decision: Approved.
Brand Name + Dosage Form + Strength Pine 300mg Tablet
Quetiapine as fumarate…..300mg
Me-too status Qusel Tablet 300mg of M/s Hilton Pharma (Pvt.) Ltd, Karachi
037691
Decision: Approved.
Brand Name + Dosage Form + Strength Terbin Tablet 125mg
Terbinafine as HCl………………………………..125mg
Me-too status Lamisil Sandoz 125mg Tab of M/s Sandoz
Karachi 013208
th
Decision: Approved.
Brand Name + Dosage Form + Strength Terbin Tablet 250mg
Terbinafine as HCl………………………………..250mg
Me-too status Lamisil Sandoz 125mg Tab of M/s Sandoz
Karachi 013209
Decision: Approved.
Brand Name + Dosage Form + Strength Lorx 4mg Tablet
Lornoxicam…………………4mg
Pack size & Demanded Price 10’s, 20’s, 30’, 50’s & As per SRO
Me-too status Lornox 4mg Tablet of M/s Ray Pharma (Pvt.) Ltd., Karachi
066713
Brand Name + Dosage Form + Strength Lorx 8mg Tablet
Lornoxicam………………..8mg
Pack size & Demanded Price 10’s, 20’s, 30’, 50’s & As per SRO

Me-too status Lornox 8mg Tablet of M/s Ray Pharma (Pvt.) Ltd., Karachi
061083
Brand Name + Dosage Form + Strength Sert Tablet 50mg
Sertraline as HCl……….…50mg
Pharmacological Group Anti- depressant/ SSRI
Me-too status Zoloft Tablets 50mg of M/s Pfizer Laboratories Ltd, Karachi
020855
Decision: Approved.
Brand Name + Dosage Form + Strength Sert Tablet 100mg
Sertraline as HCl……...…100mg
Me-too status Zoloft Tablets 50mg of M/s Pfizer Laboratories Ltd, Karachi
020856
Decision: Approved.
Brand Name + Dosage Form + Strength Top Tablet 200mg
Topiramate………………200mg

Me-too status Topirax Tablets 200mg of M/s Feroza International
Pharmaceuticals (Pvt.) Ltd,Lahore041657
Decision: Approved.
Brand Name + Dosage Form + Strength Febuxogood Tablet 40mg
Febuxostat………………....40mg
Pharmacological Group Anti- gout
Pack size & Demanded Price 2x 10’s & as per SRO
Me-too status Febux Tablet 40mg of M/s CCL Pharma Lahore
068106
Brand Name + Dosage Form + Strength Febuxogood 80mg Tablet
Febuxostat…..80mg
Pharmacological Group Anti- gout
Approval status of product in Reference ANSM; France approved
Me-too status Febux Tablet 80mg of M/s CCL Pharma Lahore
068107
Brand Name + Dosage Form + Strength BAC Tablet 10mg
Baclofen………………......10mg

Me-too status Lioresal 10mg Tablets of Novartis Pharma (Pakistan) Ltd,
Karachi 027275
Decision: Approved.
Brand Name + Dosage Form + Strength Zapol Tablet 5mg
Olanzapine as Citrate…….…5mg
Me-too status Olanzapine-Sandoz 5mg Tablets of M/s Novartis Pharma,
Karachi 048411
Decision: Approved.
Brand Name + Dosage Form + Strength Zapol Tablet 10mg
Olanzapine as Citrate..….…10mg
Me-too status Olanzapine- Sandoz 10mg Tablets of M/s Novartis Pharma,
Karachi 048412
Decision: Approved.
Brand Name + Dosage Form + Strength Dula Capsule 30mg
Duloxetine as HCl (enteric coated pellets) ..……..30mg
th
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s & As per SRO
Me-too status Dulox 30mg Capsule of M/s Kaizen Pharma Karachi 076232
Remarks of the EvaluatorXIII  General capsule section is available in the firm as
 Source of pellets is M/s Vision Pharmaceuticals.
 But stability data of pellets, CoA of manufacturer and
GMP certificate of manufacturer of pellets is not
 The official monograph for this applied formulation is
available in USP.
Decision: Deferred for stability studies data of pellets, CoA of manufacturer, GMP certificate of
supplier and differential fee in case of import of pellets.
Brand Name + Dosage Form + Strength Dula Capsule 60mg
Duloxetine as HCl (enteric coated pellets)………..60mg
Pack size & Demanded Price 1x 10’s & As per SRO
Me-too status Dulox 60mg Capsule of M/s Kaizen Pharma Karachi 076231
 General capsule section is available in the firm as
 Source of pellets is M/s Vision Pharmaceuticals.
 But stability data of pellets, CoA of manufacturer and
GMP certificate of manufacturer of pellets is not
 The official monograph for this applied formulation is
available in USP.
Decision: Deferred for stability studies data of pellets, CoA of manufacturer, GMP certificate of
supplier and differential fee in case of import of pellets.
Brand Name + Dosage Form + Strength Omenate Capsule 20/1100mg
Omeprazole…………………………………………20mg
Sodium bicarbonate………………………………1100mg
Pharmacological Group Not submitted
Me-too status Omeprafast of M/s Bio-Labs (Pvt.) Ltd. 065376

 Applied pharmacological group is not mentioned.
Decision: Deferred for submission of applied pharmacological group.
Brand Name + Dosage Form + Strength Omenate Capsule 40/ 1100mg
Omeprazole…………………………………………40mg
Sodium bicarbonate………………………………1100mg
Pharmacological Group PPI/ Antacid
Me-too status Omeprafast of M/s Bio-Labs (Pvt.) Ltd. 065377
 Applied pharmacological group is not mentioned.
Decision: Deferred for submission of applied pharmacological group.
Brand Name + Dosage Form + Strength Gaybal Capsule 75mg
Pregabalin………75mg
Pack size & Demanded Price 2x 7’s &As per SRO
Me-too status Pregalax Capsule of M/s Magns Pharmaceuticals, Faisalabad.
084136
Brand Name + Dosage Form + Strength Gaybal Capsule 100mg
Pregabalin……..100mg

Me-too status Pregalax Capsule of M/s Magns Pharmaceuticals, Faisalabad.
084137
Brand Name + Dosage Form + Strength Pineflux Capsule 3mg/25mg
Olanzapine…………….………………………….…3mg
Fluoxetine HCl……………………………………..25mg
Pack size & Demanded Price 14’s, 30’s &As per SRO
Me-too status Co- Depricap 3/ 25 Capsule of M/s Nabi Qasim, Karachi
076136
Decision: Approved.
Brand Name + Dosage Form + Strength Pineflux Capsule 6mg/ 25mg
Olanzapine…………….………………………….…6mg
Me-too status Olanzakson Capsule of M/s Akson Pharmaceuticals Pvt Ltd,
Islamabad 081659
Decision: Approved.
Brand Name + Dosage Form + Strength Pineflux Capsule 12mg/ 25mg
Olanzapine…………….…………………………...12mg
th
Me-too status Olanzakson DS Capsule of M/s Akson Pharmaceuticals Pvt
Ltd, Islamabad 081658
Decision: Approved.
1356. Name and address of manufacturer/ M/s Zeta Pharmaceuticals, 494-A, Sundar Industrial Estate,
Applicant Lahore.
Brand Name + Dosage Form + Strength Zestine 10mg Tablet
Ebastine……..10mg
Pharmacological Group Anti- histamine
Finished product Specification USP/ BP
Pack size & Demanded Price As per DRAP policy
Approval status of product in Reference Approved in ANSM; France as film- coated
Me-too status Ebastine 10mg Tabletsof M/s Alina Combine Karachi
045251
GMP status GMP certificate has been submitted on the basis of evaluation
done on 25-10-2019.
 Firm has General tablet section as mentioned in the
submitted GMP certificate.
 Approved in ANSM; France as film- coated while
initially the firm applied uncoated tablet.
 Now, the firm has revised the applied formulation
according to the reference but has not submitted the
requisite fees for revision of formulation.
 USP or BP is applied while the official monograph for
the applied formulation is in JP.
Decision: Deferred for submission of requisite fee for revision of formulation.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zetapram Tablet 5mg
Escitalopram as Oxalate…………………………….5mg
Finished product Specification USP/ BP
Pack size & Demanded Price 14's & As per SRO
Approval status of product in Reference Approved in MHRA as film- coated tablet
Me-too status Escital Tablet of M/s Helix Pharma 061634
done on 25-10-2019.

Remarks of the EvaluatorXIII  Firm has General tablet section as mentioned in the
 Approved in MHRA as film- coated while initially the
firm applied uncoated tablet.
available in USP.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zeprox 550mg Tablet
Naproxen Sodium………………………………...550mg
Pack size & Demanded Price 20' & As per DRAP policy
Approval status of product in Reference Crysanal 550mg film coated tablet by M/s Atnahs Pharma
Regulatory Authorities. Australia Pty Ltd, TGA Australia Approved.
Me-too status Xaprox tablets 550mg of M/s Pfizer Pakistan (Reg.# 067374)
done on 25-10-2019.
available in USP.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zetadine Tablet 10mg
Loratadine…………………10mg
Approval status of product in Reference Approved in MHRA and Netherland as uncoated
Me-too status Senergy OD 10mg tablet of M/s Highnoon
(Reg.# 017672)
done on 25-10-2019.
 Approved in MHRA as uncoated while initially the firm
applied film- coated tablet.

according to the reference and has submitted the
requisite fees for revision of formulation i.e. Rs. 5000/-
.
available in USP.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zeptin- M 50/500mg Tablets
Sitagliptin as Phosphate Monohydrate…………..…50mg
Metformin HCl……………………………………500mg
Pharmacological Group Biguanides
Approval status of product in Reference TGA; Australia Approved
Me-too status S- Gliptin Plus Tablets of M/s Barrett Hodgson 076344
done on 25-10-2019.
Remarks of the EvaluatorXIII Firm has General tablet section as mentioned in the submitted
GMP certificate.
The applied formulation is non- pharmacopoeial.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zeptin M 50/1000mg Tablets
Sitagliptin as phosphate monohydrate……………...50mg
Metformin HCl………………………………..…1000mg
done on 25-10-2019.
Remarks of the EvaluatorXIII Firm has General tablet section as mentioned in the submitted
GMP certificate.
Applicant Lahore.
Brand Name + Dosage Form + Strength Duloxeta 30mg Capsule
Composition Each capsule (enteric- coated pellets) contains:
Duloxetine HCl…………………………...30mg
Pack size & Demanded Price 10's & Rs. 250/-
Approval status of product in ReferenceCymbalta (Duloxetine 30 mg capsule) by M/s Eli Lilly,
Regulatory Authorities. USFDA
Me-too status Dulan 30mg by M/s Hilton Pharma. (Reg.# 055447)
done on 25-10-2019.
XIII
Remarks of the Evaluator Firm has General tablet section as mentioned in the submitted
GMP certificate.
Source of pellets is M/s Vision Pharma and all the data related
with pellets is submitted.
Applicant Lahore.
Brand Name + Dosage Form + Strength Duloxeta 20mg Capsule
Composition Each cap enteric coated pellets contains:
Duloxetine HCl…20mg
Pack size & Demanded Price 14's & as per sro
Me-too status Dulan 20mg Capsule of Hilton Pharma (Pvt.) Limited 055446
done on 25-10-2019.
XIII
Remarks of the Evaluator Firm has General tablet section as mentioned in the submitted
GMP certificate.
Source of pellets is M/s Vision Pharma and all the data related
with pellets is submitted.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zetapram Tablet 10mg
Escitalopram as Oxalate….....................................10mg
Pack size & Demanded Price 14' s & As per DRAP policy
Approval status of product in Reference Approved in MHRA as film- coated tablet
Me-too status Escital Tablet Helix Pharma (Pvt.) Ltd; 061634
done on 25-10-2019.
available in USP.
1365. Name and address of manufacturer/ M/s Zeta Pharmaceuticals, Plot # 494-A, Sundar Industrial
Applicant Estate, Lahore.
Brand Name + Dosage Form + Strength Zetac 50mg Tablet
Composition Each enteric- coated tablet Contains:
Type of Form Form-5
Pack size & Demanded Price 2x 10's & as per SRO
Me-too status Arthopan of M/s Safe Pharma 061790
done on 25-10-2019.
Remarks of the EvaluatorXIII  Ratio of misoprostol is not being mentioned in the reply.
Decision: Deferred for clarification regarding Misoprostol ratio in the applied formulation.
Applicant Lahore.
Brand Name + Dosage Form + Strength Zetac 75mg Tablet
Composition Each enteric- coated tablet contains:
Diclofenac Sodium…...................................75mg
Misoprostol…...........................................200mcg
Type of Form Form-5
Pack size & Demanded Price 2 x 10's & as per SRO
Me-too status Artho Plus Shaigan Pharma 063196
done on 25-10-2019.
Remarks of the EvaluatorXIII Ratio of misoprostol is not being mentioned in the reply.
Firm has General tablet section as mentioned in the submitted
GMP certificate.
Decision: Deferred for clarification regarding Misoprostol ratio in the applied formulation.
1367. Name and address of manufacturer/ M/s Lawari International Pharmaceuticals, Valley Road, Gul
Applicant KADU Saidu Sharif Swat, KPK
Brand Name + Dosage Form + Strength Repram 10mg Tablet
Escitalopram as Oxalate….10mg
Pharmacological Group SSRIs/ Anti- depressant
Approval status of product in Reference Approved in MHRA
Me-too status Escital Tablet Helix Pharma (Pvt.) Ltd;061634
GMP status Not provided
Remarks of the EvaluatorXIII  Justification given by firm for 2% overage is as follows:
“As per official monograph, the limit of raw material is
as 98-99% to 101-102%. Therefore, we are adding 2%
overages in our formulation for the safety of our
products.”
th
 For GMP inspection report, firm clarifies that its
inspection is pending due to current situation of Covid-
19 and unavailability of Area FID-III.
 Section needs to be verified.
firm.
Brand Name + Dosage Form + Strength Sitametin 50/ 500mg Tablet
Composition Each film- coated Tablet Contains:
Sitagliptin as Phosphate Monohydrate ………….50mg
Metformin HCl……………………………...….500mg
Remarks of the EvaluatorXIII  The applied formulation is non- pharmacopoeial.
DecisionRegistration Board referred the case to QA & LT Division for updated GMP status of the
firm.
Brand Name + Dosage Form + Strength Sitametin 50/ 1000mg Tablet
Sitagliptin as Phosphate Monohydrate ………….50mg
Metformin HCl……………………………...…1000mg
firm.
Brand Name + Dosage Form + Strength Montekal 10mg Chewable Tablet
Composition Each Chewable Tablet Contains:
Montelukast as Sodium…10mg

Pharmacological Group Leukotriene Receptor Antagonist
Pack size & Demanded Price 1x 14’s & Rs. 24/- per tablet
Approval status of product in ReferenceCould not be confirmed as chewable tablet (4 & 5mg are
Regulatory Authorities. available)
Me-too status Montekast 10mg Tablets of M/s Global Pharmaceutical,
Industrial Triangle, Kahuta Road 032154
Remarks of the EvaluatorXIII  The official monograph for the applied formulation is
available in USP.
 Could not be confirmed internationally as chewable
tablet.
 On applying initially as chewable tablet, firm replies:
A clerical mistake occurs in our applied
application of Montelukast Sodium 10mg chewable
tablets but actually, we have applied for Montelukast
Sodium 10mg film- coated tablet which has now been
corrected in revised master formulation.
Decision: Deferred for following reasons:
 Revision of formulation as per reference product along with submission of requisite fee.
 Confirmation of required manufacturing facility /section from Licensing Division.
 Registration Board referred the case to QA & LT Division for updated GMP status of the
firm.
Brand Name + Dosage Form + Strength Tatinid 500mg Tablet
Tinidazole…......................500mg
Me-too status Tinidazole 500mg tablet of PDH Lahore 009757
Remarks of the EvaluatorXIII  For GMP inspection report, firm clarifies that its
firm.
Applicant KADU Saidu Sharif Swat, KPK.
Brand Name + Dosage Form + Strength Taneprox 500mg Tablet
Naproxen sodium eq. to Naproxen……………..500mg

Approval status of product in Reference MHRA Approved as uncoated
Me-too status Naprox Tab 500mg of M/s Pharmedic Lahore
Remarks of the EvaluatorXIII  The official monograph is in USP.
 On applying initially as film-coated tablet, firm replies:
A clerical mistake occurs in our applied
application of Naproxen sodium 10mg film-coated
tablets but actually, we have applied for Naproxen
sodium 10mg uncoated tablet which has now been
corrected in revised master formulation.
 Revision of formulation as per reference product along with submission of requisite fee.
firm.
Brand Name + Dosage Form + Strength Tablinez 600mg Tablet
Linezolid…….600mg
Approval status of product in Reference ANSM; France Approved as film- coated
Me-too status Linez 600mg Tablet of M/s Nexus Pharma (Pvt.)Ltd
Korangi Industrial Area, Karachi (Reg. # 061309)
Remarks of the EvaluatorXIII  In applied master formulation, Azithromycin is applied
whch the firm says says is due to clerical mistake.
 Total applied composition was different than the applied
one.
Decision: Deferred for following clarifications:
 Form 5 for correction in composition with fee.
 Total applied composition was different than the applied one.
firm.
Brand Name + Dosage Form + Strength Codofen Tablets 20mg/ 200mg
Codeine Phosphate……………………………..…20mg
Ibuprofen………………………………………...200mg

Me-too status Brufen Plus of M/s Abbott
as 98- 99% to 101- 102%. Therefore, we are adding 2%
products.”
 International reference could not be confirmed.
Decision: Deferred For Following:
 Stability Data for overage used in formulation.
 Approval Status Reference Regulatory Authorities.
 Registration Board Referred to QA & LT Division for updated GMP Status of the firm
 Narcotic Section Approval By Licensing Division.
Brand Name + Dosage Form + Strength Tapride 50mg Tablet
Levosulpiride…50mg
Diary No. Date of R & I & fee Dy.No.11441dated 05-03-2019 Rs.20,000/- Dated 05-03-2019
Approval status of product in Reference Approved by AIFA (Italy)
Me-too status Caresul 50mg Tablet of Tabros Pharma (Pvt.) Ltd
Karachi 066757
Remarks of the EvaluatorXIII  The applied formulation is non- pharmacopoeial.
firm.
Brand Name + Dosage Form + Strength Seizugab 100mg Capsule
Gabapentin……100mg

Me-too status Gabaplus Capsule 100mg of M/s Platinum Pharmaceuticals
Qasim Karachi 035664
 Justification given by firm for 2% overage is as follows:
products.”
 The official monograph is available in USP.
firm.
Brand Name + Dosage Form + Strength Seizugab 300mg Capsule
Gabapentin……300mg
Me-too status Gabapa 300mg Capsule of M/s Farm Aid Group Hattar
056721
products.”
firm.
Brand Name + Dosage Form + Strength Cangio- A 5/80mg Tablet
Amlodipine besylate eq. to Amlodipine………… 5mg
Valsartan…………………………………………80mg
Approval status of product in Reference MHRA Approved as film coated
available in USP.
firm.
Brand Name + Dosage Form + Strength Cangio- A 5/160mg Tablet
Amlodipine as Besylate…………………………...5mg
Valsartan………………………………………..160mg
available in USP.
firm.
Brand Name + Dosage Form + Strength Spaslax 3mg Tablet
Oxybutynin HCl…………………………………...3mg
Pharmacological Group Urologicals
Me-too status Oxitrin Tablets 3mg of Dr. Raza Pharma (Pvt.) Ltd, 44-C,
Industrial Estate Hayatabad, Peshawar 023896
products.”
 The official monograph is available in BP.

 Stability Data for overage used in formulation
firm.
Brand Name + Dosage Form + Strength Moximil 400mg Tablet
Moxifloxacin HCl………...400mg
Me-too status Moxifo 400mg Tablet of M/s Tabros Pharma, Karachi
048764
products.”
 Stability Data for overage used in formulation
firm.
Brand Name + Dosage Form + Strength Aspidogrel 75mg/75mg Tablet
Clopidogrel as Hydrogen sulphate ……………...75mg
Aspirin…………………………………………...75mg
Pharmacological Group Anti- thrombotic
Approval status of product in Reference Approved in TGA; Australia
Me-too status Clopid ASP 75 tablet of M/s Ferozsons Labs Amangarh,
Nowshera. 043643

products.”
firm.
 Clarification of manufacturing outline in the light of innovator product and requisite facility.
1383. Name and address of manufacturer/ M/s Ray Pharma Pvt. Ltd, S-58, S.I.T.E Karachi, Pakistan.
Applicant
Brand Name + Dosage Form + Strength Rickdil tablet 0.25mcg
Alfacalcidol…….……...0.25mcg
Pharmacological Group Vitamin- D and analogues
Pack size & Demanded Price 30’s & As per SRO
Approval status of product in Reference PMDA; Japan Approved as uncoated tablet
Me-too status Bonedol 0.25mcg Tablets of M/s Pharmevo, Karachi 036614
report concludes good level of GMP compliance.
mentioned in the submitted GMP inspection report.
Initially, firm had applied uncoated tablet.
 Now, the firm has revised its formulation according to
the reference as uncoated tablets with submission of Rs.
5000/- requisite fees.
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Rickdil tablet 0.5mcg
Alfacalcidol…….…….....0.5mcg
Me-too status Bonedol 0.5Mcg Tablets Pharmevo, Karachi 036615
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Rickdil tablet 1mcg
Alfacalcidol………..……...1mcg
Me-too status Bonedol 1Mcg Tablets Pharmevo, Karachi 035538
Applicant
Brand Name + Dosage Form + Strength Desil Tablet 5mg
Desloratadine ………….…5mg
Me-too status Deslort 5mg Tablet of M/s Panacea Pharmaceuticals
Rawat, Islamabad 056332
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Reonate Tablet 10mg
Alendronate Sodium eq. to Alendronic Acid……10mg
Me-too status Alendroflex 10mg Tablets of M/s Novins International,
Karachi 042386
XIII
Remarks of the Evaluator General tablet section is available in the firm as mentioned in the
submitted GMP inspection report.
th
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Reonate Tablet 70mg
Alendronate Sodium eq. to Alendronic Acid………70mg
Me-too status Alendroflex 70mg tablets of Novins International, Karachi
042387
Remarks of the EvaluatorXIII General tablet section is available in the firm as mentioned in the
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Ciprova Tablet 250mg
Ciprofloxacin as HCl .…250mg
Pharmacological Group Fluoro- quinolone
Me-too status Medociprin 250mg tablet of M/s Medochemie Cyprus Alina
Combine Karachi 012162
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Ciprova Tablet 500mg
Ciprofloxacin as HCl.…...500mg
Me-too status Ciproxin 500 tablet of M/s Bayer Karachi 013329
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Ciprova XR Tablet 500mg
Composition Each extended- release tablet contains:
Ciprofloxacin as HCl…………500mg
Approval status of product in Reference USFDA Approved as bi-layered tablets consisting
Regulatory Authorities of an immediate-release layer and an erosion-matrix type
controlled- release layer.
Me-too status Ciproscot XR Tablets of M/s Scotmann Pharmaceuticals
Islamabad.
available in USP.
 Innovator formulation:
CIPRO XR tablets are coated, bilayer tablets
consisting of an immediate-release layer and an
erosion- matrix type controlled-release layer. The
tablets contain a combination of two types of
ciprofloxacin drug substance, ciprofloxacin
hydrochloride and ciprofloxacin betaine (base).
 Initially, firm had applied extended- release tablet.
Now, revision of formulation as per innovator is done
by the firm with submission of Rs. 5000/- fees and
evidence of bilayered machine has also been
submitted.
Decision: Deferred for further deliberation upon manufacturing outine of applied formulation in
the light of innovator’s product.
Applicant
Brand Name + Dosage Form + Strength Ciprova XR Tablet 1000mg
Composition Each extended- release tablet contains:
Ciprofloxacin as HCl………..1000mg
Approval status of product in Reference USFDA Approved as bi-layered tablets consisting
Regulatory Authorities. of an immediate- release layer and an erosion- matrix type
controlled- release layer.
Me-too status Makcip XR Tablets of M/s Makson Pharmaceuticals Islamabad
070014
available in USP.

Innovator formulation:
CIPRO XR tablets are coated, bilayer tablets
consisting of an immediate-release layer and an
erosion- matrix type controlled-release layer. The
tablets contain a combination of two types of
ciprofloxacin drug substance, ciprofloxacin
hydrochloride and ciprofloxacin betaine (base).
 Initially, firm had applied extended- release tablet.
Now, revision of formulation as per innovator is done
by the firm with submission of Rs. 5000/- fees and
evidence of bilayered machine has also been
submitted.
Decision: Deferred for further deliberation upon manufacturing outine of applied formulation in
the light of innovator’s product.
Applicant
Brand Name + Dosage Form + Strength Rheuma 10mg Tablet
Leflunomide…………..…..10mg
Pharmacological Group Anti- rheumatic
Me-too status Lefluno Tablet of M/s Caraway Pharmaceuticals, Islamabad
050062
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Rheuma 20mg Tablet
Leflunomide……….……..20mg
Pharmacological Group Anti- rheumatic
Me-too status Lefluno Tablet of M/s Caraway Pharmaceuticals, Islamabad.
050063
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Dexofin Tablet 200mg
Dexibuprofen……….…...200mg
Me-too status Dexib 200mg Tablet of M/s Tabros Pharmaceutical Karachi
067491
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Dexofin 300mg Tablet
Dexibuprofen….………...300mg
Me-too status Dexib 300mg Tablet of M/s Tabros Pharmaceutical Karachi
067493
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Sofen Ophthalmic Ointment 10%/ 0.2%
Sulfacetamide sodium…………...100mg
Prednisolone acetate………………..2mg
Pharmacological Group Corticosteroids and anti- infective
Pack size & Demanded Price 3.5gx 1’s & As per SRO
Me-too status Predmide Ophthalmic Ointment of M/s Remington
Pharmaceutical Industries, Lahore 026903
Remarks of the EvaluatorXIII Cream/ Ointment/ Gel (Antibiotics with steroids) section is
inspection report.
Decision: Deferred for confirmation of separate dispensing booth as per decision of Licensing Board.
Applicant
Brand Name + Dosage Form + Strength Raygil Infusion 500mg/100ml
Metronidazole…………………………………..500mg
Me-too status Metrida I.V Infusion of M/s Zafa Pharmaceuticals Laboratories
(Pvt.) Ltd Baluchistan 026232
XIII
Remarks of the Evaluator General liquid injectable section is available in the firm as
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Raydex- T Ophthalmic ointment
Dexamethasone…………………………….…0.3% 3mg
Tobramycin…………………………………..0.1% 1mg
Pharmacological Group Corticosteroid /Anti- infective
Me-too status Tobradex Ointment of M/s Ali Gohar & Co Karachi 017041
Remarks of the EvaluatorXIII Cream/ Ointment/ Gel (Antibiotics with steroids) section is
inspection report.
Decision: Deferred for confirmation of separate dispensing booth as per decision of Licensing
Board.
Applicant
Brand Name + Dosage Form + Strength Raymox 0.5% Eye Ointment
Moxifloxacin as HCl …………………... 5mg (0.5%)
Pharmacological Group Fluoroquinolone Antibiotic
Approval status of product in Reference Could not be confirmed as ointment
Me-too status Ocumox of M/s Remington Pharmaceutical Industries (Pvt.)
Ltd., Lahore 069155
XIII
Remarks of the Evaluator Cream/ Ointment/ Gel (Antibiotics with steroids) section is
inspection report.
Non- pharmacopoeial.
Reference could not be confirmed as ointment.
 Evidence of approval of applied formulation in reference regulatory authorities/ agencies
 Confirmation of required manufacturing facility / section from Licensing Division.
Applicant
Brand Name + Dosage Form + Strength Ciprova 125mg/ 5ml Powder for suspension
Ciprofloxacin eq. to Ciprofloxacin……………..125mg
Me-too status Hiflox 125mg/5ml Dry Suspension of M/s Hilton Pharma
(Pvt.) Limited; Korangi, Karachi 067498
Remarks of the EvaluatorXIII  Dry powder suspension (Antibiotic) section is available
in the firm as mentioned in the submitted GMP
inspection report.
 Source of granules is Zhejiang Jingxi
Pharmaceutical, China whose CoA copy is
submitted.
 Registration Board in its 269th meeting decided as
follows:
Keeping in view the following statement written in
Qualitative and quantitative composition “2.5 ml
suspension after reconstitution (1/2 measuring
spoon) contains 125 mg ciprofloxacin” and domestic
conditions for difficulties in dispensing 250mg/5ml
suspension for children under 2 years of
age,.Registration Board decided to approve the
formulation of ciprofloxacin 125mg/5ml granules
and solvent for oral suspension as per reference
product approved by USFDA and MHRA.
Applicant
Brand Name + Dosage Form + Strength Ciprova 250mg/ 5ml Powder for suspension
Ciprofloxacin eq. to Ciprofloxacin……………..250mg
Me-too status Ciplet 250mg/5ml Suspension of M/s Indus Pharma Karachi
073479

Remarks of the EvaluatorXIII Dry powder suspension (Antibiotic) section is available in the
firm as mentioned in the submitted GMP inspection report.
Applicant
Brand Name + Dosage Form + Strength Ciprova Infusion 200mg/100ml
Ciprofloxacin HCl eq. to Ciprofloxacin………..200mg
Pack size & Demanded Price 100ml & As per SRO
Me-too status Caralox Infusion of M/s Caraway Pharmaceuticals,
Islamabad 050044
Remarks of the EvaluatorXIII General liquid injectable section is available in the firm as
Decision: Approved.
1404. Name and address of manufacturer/ M/s Ray Pharma Pvt. Ltd, S- 58, S.I.T.E Karachi, Pakistan.
Applicant
Brand Name + Dosage Form + Strength Ciprova DS 400mg/ 100ml Infusion
Ciprofloxacin HCl……………………………...400mg
Me-too status Novidat DS 400mg/100ml Infusion Sami Pharmaceutical,
Karachi 042270
Reference could not be confirmed.
authorities/ agencies which were adopted by the Registration Board in its 275th meeting.
Applicant
Brand Name + Dosage Form + Strength Rayvir 250mg Infusion I/V
Acyclovir sodium eq. to Acyclovir…………….250mg
Pharmacological Group Anti- viral
Pack size & Demanded Price 10ml vial & As per SRO
Approval status of product in Reference Aciclovir Sandoz IV Infusion Aciclovir 250mg powder for
Regulatory Authorities. injection vial, TGA: Australia Approved
Me-too status Zovirax Infusion of M/s Glaxo Smith Kline Karachi 009975

Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Rayvir 500mg Infusion I/V
Acyclovir sodium eq. to Acyclovir……………..500mg
Pack size & Demanded Price 20ml vial & As per SRO
Approval status of product in Reference Aciclovir Sandoz IV Infusion Aciclovir 500mg powder for
Regulatory Authorities. injection vial, TGA; Australia Approved
Me-too status Acyclovir infusion 500mg of M/s Abbott (021397)
 General liquid injectable section is available in the firm
as mentioned in the submitted GMP inspection report.
 25mg is written in the applied composition while 500mg
is applied.
Decision: Deferred for clarification as 25mg is written in the applied composition while 500mg is
applied.
Applicant
Brand Name + Dosage Form + Strength Ray- D Injection 5mg/ml
Cholecalciferol -Vit D3……………………………5mg
Pharmacological Group Vitamin- D and analogue
Pack size & Demanded Price 1ml x 5’s & As per SRO
Me-too status Get- D 5mg/ml Injection of M/s Getz Pharma (Pvt.) Ltd.
Karachi 067547
1408. Name and address of manufacturer/ M/s Ray Pharma Pvt. Ltd, S- 58, S.I.T.E Karachi, Pakistan.
Applicant
Brand Name + Dosage Form + Strength Rayvir 200mg Tablet
Acyclovir sodium eq. to Acyclovir…………….200mg
Approval status of product in Reference TGA; Australia Approved as dispersible film- coated tablet
Me-too status Cycloz Tablet of M/s Highnoon Lahore 012392
 In reference, it is as dispersible film- coated tablet.
Decision: Deferred for the clarification of manufacturing outline as in reference regulatory
authorities the approved drug is dispersible film- coated tablet, while the applied drug is film-
coated tablet.
Applicant
Brand Name + Dosage Form + Strength Roxib Tablets 60mg
Etoricoxib…………….…...60mg
Me-too status Etoricox 60mg Tablet of Kaizen Pharma Karachi 076226
XIII
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Reonate- D Tablet 70mg/ 2800 IU
Alendronate as Sodium eq. to Alendronic sodium….70mg
Cholecalciferol…………….………….…2800IU (70mcg)
Pharmacological Group Drugs for treatment of bone diseases/ Bisphosphonate
Me-too status Alonate- D of M/s Neo Medix Islamabad 066467
Decision: Approved.
Applicant
Brand Name + Dosage Form + Strength Artichin Injection 4mg/2ml I/M
Thiocolchicoside……..4mg

Me-too status Thiocol 4mg/ 2ml Injection of M/s Ray Pharma (Pvt.) Ltd.,
Karachi 066712
Applicant
Brand Name + Dosage Form + Strength Artichin 4mg Capsule
Thiocolchicoside………………………………….4mg
Me-too status Thiocol 4mg Capsule of M/s Ray Pharma (Pvt.) Ltd., Karachi
066711
XIII
Remarks of the Evaluator General capsule section is available in the firm as mentioned in
the submitted GMP inspection report.
1413. Name and address of manufacturer/ M/s Eros Pharmaceuticals Pvt. Ltd., Plot # 94-95, Sector 23,
Applicant Korangi Industrial Area Karachi.
Contract Manufacturer
M/s Mediate Pharmaceutical Pvt. Ltd. Plot No. 150-151, Sector 24,
Korangi Industrial Area, Karachi, Pakistan.
Brand Name + Dosage Form + Strength Ezone Injection 1000mg
Cefoperazone as Sodium……….…………....….500mg
Sulbactam as Sodium………….…………......…500mg
Pharmacological Group Cephalosporin/ Beta Lactam Inhibitor
Pack size & Demanded Price 1 vial dry substance + 5ml ampoule water for injection & As
per SRO
Me-too status Ectafin Injection 1gm I/V of M/s Hi-Medic Pharmaceuticals
(Pvt.) Ltd, 19- KM link Multan Road, Lahore 080028
GMP status M/s Eros Pharma:
Last GMP inspection was conducted on 11-12-2018 and the
report concludes :
Keeping in view the request of the firm, the competent Authority
is pleased to constitute the panel for thorough cGMP inspection
of the Ophthalmic section of the firm and for the verification of
improvements before resumption of production.
M/s Mediate Pharma:
report concludes acceptable level of good compliance.
Remarks of the EvaluatorXIII  Manufacturer firm has Dry powder injection
Cephalosporin section as mentioned in the submitted
DML.
available in USP.
 No. of sections of applicant needs to be submitted.
 No. of approved drugs on contract basis needs to be
submitted.
 Section approval letter of applicant needs to be
submitted.
 Number of sections of applicant needs to be submitted.
 Number of approved drugs of applicant on contract basis needs to be submitted.
Brand Name + Dosage Form + Strength Maxpime 500mg Injection I/V, I/M
Cefepime HCl with L- Arginine…………………..500mg
Approval status of product in Reference TGA Australia Approved as Cefepime hydrochloride
Regulatory Authorities. monohydrate equivalent to Cefepime 500 mg, powder for
injection
Me-too status Cefstar Injection 500mg of M/s Barrett Hodgson Pakistan
(Pvt.) Ltd, S.I.T.E, Karachi 030953
report concludes:
M/s Mediate Pharma:
available in USP.
 Revise the label claim and master formulation as
Cefepime hydrochloride monohydrate equivalent to
Cefepime as in TGA, Australia. Correction along with
adjustment of its weight as per salt factor needs to be
submitted.
submitted.
submitted.
 Volume of injection and pack size needs to be
submitted.
 Revision of label claim alongwith adjustment of weight of salt factor in master formulation
 Number of products already approved on contract manufacturing.
 Number of sections approved for M/s Eros pharmaceuticals pvt. Ltd., Karachi.
Brand Name + Dosage Form + Strength Maxpime 1000mg Injection
Cefepime HCl with L- Arginine………………....1000mg
Approval status of product in Reference TGA Australia Approved as Cefepime hydrochloride
Regulatory Authorities. monohydrate equivalent toCefepime 1g, powder for injection
Me-too status Cefstar Injection 1g of M/s Barrett Hodgson Pakistan (Pvt.)
Ltd, S.I.T.E, Karachi. 030954
report concludes:
M/s Mediate Pharma:
available in USP.
 Revise the label claim and master formulation as
Cefepime hydrochloride monohydrate equivalent to
Cefepime as in TGA, Australia. Correction along with
adjustment of its weight as per salt factor needs to be
submitted.
submitted.
submitted.
submitted.
 Revision of label claim alongwith adjustment of weight of salt factor in master formulation
 Number of sections approved for M/s eros pharmaceuticals pvt. Ltd., Karachi.
Brand Name + Dosage Form + Strength Ferofer Injection 100mg
Iron sucrose complex eq. to elemental iron….…100mg
Pharmacological Group Anti- anaemic
Approval status of product in Reference Approved in USFDA as single dose vial
Me-too status Ferotein- S Injection of M/s Getz Pharma, Karachi
(Reg. # 055440)
report concludes :
M/s Mediate Pharma:
Remarks of the EvaluatorXIII  Manufacturer firm has Liquid ampoule General
injection section as mentioned in the submitted DML.
available in USP.
submitted.
submitted.
 Ampoule or vial what is applied not confirmed.
submitted.
 Submission of details of primary packaging whether vial or ampoule.
Brand Name + Dosage Form + Strength P- Zac Infusion 40mg (powder for infusion)
Composition Each amber glass vial contains:
Pantoprazole……………40mg
Pack size & Demanded Price Amber glass vial As per SRO
Me-too status Zentro Injection of M/s Bosch, Karachi 045388
report concludes :
M/s Mediate Pharma:
Remarks of the EvaluatorXIII  Approved in MHRA as Pantoprazole as sodium
sesquihydrate
 General infusion section is available in the
manufacturers firm as mentioned in the submitted DML.
submitted.
submitted.
 Strength of infusion is not mentioned.
submitted.
 Revision of salt form as per reference product.
 Number of sections approved for M/s Eros pharmaceuticals pvt. Ltd., Karachi
Brand Name + Dosage Form + Strength Esma Infusion 40mg I/M
Composition Each vial Contains:
Esomeprazole as Sodium……………………..40mg
Approval status of product in Reference MHRA Approved as lyophilized powder
Me-too status Somezol of M/s Bosch 045386
report concludes :
M/s Mediate Pharma:
Remarks of the EvaluatorXIII  General infusion section is available in the
manufacturers firm as mentioned in the submitted
DML.
 The applied drug is non- pharmacopoeial.
submitted.
submitted.
submitted.
 MHRA Approved as lyophilized powder.
Brand Name + Dosage Form + Strength Ezone Injection 2000mg
Cefoperazone Sodium……………………..…1000mg
Sulbactam Sodium……………………………1000mg
Pharmacological Group Cephaolsporin Antibiotic
Me-too status Q- Bact 2gm Injection of High- Q Karachi 061170
report concludes :
M/s Mediate Pharma:
Remarks of the EvaluatorXIII  Manufacturer firm has Dry powder injection
(Cephalosporin) section as mentioned in the submitted
GMP inspection report.
submitted.
submitted.
 Pack size needs to be submitted.
available in JP.
 Cefoperazone sodium eq. to Cefoperazone is approved
in reference.
 Sulbactam sodium eq. to Sulbactam is approved in
reference.
 Revision of label claim as per reference product
Brand Name + Dosage Form + Strength Vit-3 Injection 5mg
Cholecalciferol……………………...5mg (200,000IU)
Pharmacological Group Vitamin- D and analogue
Me-too status Get- D 5mg/ml Injection of M/s Getz Pharma (Pvt.) Ltd.
Karachi 067547
report concludes :
M/s Mediate Pharma:
Remarks of the EvaluatorXIII  Manufacturer firm has Liquid ampoule General
injection section as mentioned in the submitted DML.
submitted.
submitted.
submitted.
Brand Name + Dosage Form + Strength K- Cort 40mg/ml Injection I/V
Triamcinolone Acetonide…40mg
Pack size & Demanded Price 1 vialx 1’s & As per SRO
Approval status of product in Reference USFDA Approved as injectable suspension
Me-too status M-Kort 40mg /ml Injection of M/s Mediate Pharmaceuticals,
Karachi 057916
report concludes :
M/s Mediate Pharma:

Remarks of the EvaluatorXIII  Manufacturer firm does not have steroidal injection
section.
available in USP.
submitted.
submitted.
submitted.
 NOT FOR INTRAVENOUS USE (For Intramuscular or
Intra-articular Use Only).
 USFDA Approved as injectable suspension while is
applied as infusion.
 Revision of dosage form as per reference formulation.
1422. Name and address of manufacturer/ M/s Alen Pharmaceuticals Pvt. Ltd, 138-Nowshera Industrial,
Applicant Risalpur, KPK.
M/s Bio Labs Pvt. Ltd, Plot # 145, Industrial Triangle, Kahuta
Road, Islamabad.
Brand Name + Dosage Form + Strength Ceftam 1g Injection I/V
Cefoperazone sodium eq. to Cefoperazone…….…500mg
Sulbactam sodium eq. to Sulbactam………………500mg
Pack size & Demanded Price 1x1 vial & As per SRO
Approval status of product in Reference Sulperazon Injection of M/s Pfizer PMDA; Japan
Me-too status Ectafin Injection 1gm I/V of M/s Hi- Medic Pharmaceuticals
(Pvt.) Ltd, Multan Road, Lahore 080028
GMP status M/s Alen Pharmaceuticals: Last GMP inspection was conducted
on 15-01-2020 and the report concludes to Suspend Production
activities in all sections.
M/s Bio Labs: last GMP inspection was conducted on 25-05-
2019 and the report concludes grant of certificate of GMP Issued
on 25-05-2019.
Remarks of the EvaluatorXIII  Manufacturer firm has Dry vial Cephalosporin section
as mentioned in the submitted GMP certificate.
submitted.
submitted.
 M/s Alen Pharma has its production activities suspended
according to latest GMP report.
available in JP.

in reference.
reference.
 Number of sections approved for M/s Alen pharmaceuticals pvt. Ltd., Risalpur
 DML status of M/s Alen Pharmaceuticals pvt ltd, Risalpur.
Contract manufacturer
Road, Islamabad.
Brand Name + Dosage Form + Strength Ceftam 2g Injection
Cefoperazone sodium eq to Cefoperazone……………1g
Sulbactam sodium eq to Sulbactam…….……………..1g
Diary No. Date of R & I & fee Dy.No. 4230 dated 30-02-2019, Rs.50,000/- Dated 29-02-2019
Me-too status Ectafin Injection 2gm I/V of M/s Hi-Medic Pharmaceuticals
(Pvt.) Ltd. Reg. No. 080027
on 25-05-2019.
 Manufacturer firm has Dry vial Cephalosporin section
as mentioned in the submitted GMP certificate.
submitted.
submitted.
 M/s Alen Pharma has its production activities suspended
available in JP.
in reference.
reference.
1424. Name and address of manufacturer/ M/s Alen Pharmaceuticals Pvt Ltd, 138-Nowshera Industrial,

M/s Bio Labs Pvt Ltd, Plot # 145, Industrial Triangle, Kahuta
Road, Islamabad.
Brand Name + Dosage Form + Strength Balmin 500mcg Injection
Composition Each ampoule 1ml contains:
Mecobalamin......…500mcg
Pharmacological Group Vitamin- B
Pack size & Demanded Price Ampoule of 1mlx 10’s & As per SRO
Approval status of product in Reference PMDA; Japan Approved
Me-too status Mecobal Injection 500mcg of M/s Nabiqasim Industries (Pvt)
Ltd, Korangi Industrial Area, Karachi 030288
on 25-05-2019.
Remarks of the EvaluatorXIII  M/s Alen Pharma has its production activities suspended
submitted.
submitted.
 Manufacturer has General Ampoule section according
to the submitted GMP certificate.
Road, Islamabad.
Brand Name + Dosage Form + Strength Vamin- D3 5mg Injection I/M
Cholecalciferol-Vitamin D3…………5mg (200,000 IU)
Pharmacological Group Vitamin- D analogue
Pack size & Demanded Price 1mlx 1’s (ampoule) & As per SRO
Approval status of product in Reference Vitamin D3 Good 200,000 IU / 1 ml I/M solution for
Regulatory Authorities. injection (ANSM, France)
Me-too status Get-D 5mg/ml Injection of M/s Getz Pharma (Pvt.) Ltd.
Korangi Industrial Area Karachi 067547
on 25-05-2019.
Remarks of the EvaluatorXIII  M/s Alen Pharma has its production activities suspended
submitted.
submitted.
 Manufacturer has General Ampoule section according
to the submitted GMP certificate.
1426. Name and address of manufacturer/ M/s Pearl Pharmaceuticals, Plot No. 204, Street No.1, I-10/3,
Applicant Islamabad.
Brand Name + Dosage Form + Strength Toricox 60mg tablet
Etoricoxib………………...60mg
Me-too status Etoricox 60mg Tablet of M/s Kaizen Pharma, Kar 076226
report concludes that the firm was found in satisfactory
compliance with GMP guidelines.
Remarks of the EvaluatorXIII The applied formulation is non- pharmacopoeial.
1427. Name and address of manufacturer/ M/s Venus Pharma, 23 km, Multan Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength Furosa-V 10mg/ml Injection I/M, I/V
Furosemide…………………………………….10mg
Pharmacological Group Diuretics
Pack size & Demanded Price 3’s, 5’s,10’s, 50’s ampoules & as per SRO
Me-too status Furosemide Injection of M/s Abbott Karachi 011759
report concludes satisfactory level of GMP compliance.
Remarks of the EvaluatorXIII Liquid injection vial/ ampoule section is available in the firm as
The official monograph for the applied formulation is available
in USP.
1428. Name and address of manufacturer/ M/s News Pharma, 42-Sundar Industrial Estate, Raiwind Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength New- Lac Injection 30mg/ml
Ketorolac Trometamol………………………..30mg

Pack size & Demanded Price 5x 1ml ampoules & Rs. 750/- per pack
Approval status of product in Reference Toradol Injection of Atnahs Pharma, UK (MHRA
Regulatory Authorities. Approved)
Me-too status Toralac Injection 30mg/ml of M/s Vision Pharma
(Reg. #050290)
GMP status Last GMP Inspection of M/s News Pharma was conducted
on 26-4-2018 as a result of which GMP
certificate is provided.
Decision: Approved.
1429. Name and address of manufacturer/ M/s Invictus Pharmaceuticals, Plot No. 21, 26, Street No.NS-2,
Applicant National Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength Invilox tablet 400mg
Moxifloxacin HCl eq. to Moxifloxacin………....…400mg
Me-too status Moxiflox 400mg Tablets of M/s Ideal Pharma 054123
GMP status Last GMP inspection was conducted on 13-11- 2018, The
panel recommended the grant of DML.
Remarks of the EvaluatorXIII
Decision: Approved.
1430. Name and address of manufacturer/ M/s Invictus Pharmaceuticals, Plot No. 21,26, Street No.NS-2,
Brand Name + Dosage Form + Strength Stron 4mg Tablets
Ondansetron HCl Dihydrate Eq. to Ondansetron.....4mg
Pharmacological Group Anti- emetic
Me-too status Ondonix 4mg tablet M/s Genix Pharma 081545
Decision: Approved.
1431. Name and address of manufacturer/ M/s Invictus Pharmaceuticals, Plot No. 21,26, Street No.NS-2,
Brand Name + Dosage Form + Strength Stron 8mg Tablets
Ondansetron HCl Dihydrate Eq. to Ondansetron.....8mg
Pharmacological Group Anti- emetic
th
Me-too status Ondonix 4mg Tablet M/s Genix Pharma 081451
Decision: Approved.
1432. Name and address of manufacturer/ M/s Invictus Pharmaceuticals, Plot No. 21, 26, Street No. NS-2,
Brand Name + Dosage Form + Strength Pentol 40mg Capsule
Enteric Coated Pellets of Pantoprazole Sodium Eq. to
Pantoprazole……………………………………40mg
Pharmacological Group PPIs
Me-too status Nixpro 40mg Capsule of M/s Indus Pharma, Karachi
053492
GMP status Last GMP inspection was conducted on 13-11- 2018. The panel
 Reference could not be confirmed
 All the data related to pellets was needed.
 Initially, firm had applied capsules while now they have
changed their applied dosage form from capsules to
enteric- coated tablets with submission of 20,000 fees
under deposit slip # 1925516 (12-05-2020).
 Applied label claim is now:
Each enteric- coated tablet contains:
Pantoprazole……………………40mg
 Tablets are ANSM; France Approved.
 Me- too of tablets is:
Kinzole Tablets of M/s Tagma Pharma (Pvt), Lahore
024212.
 The official monograph for tablets is available in USP.
 Form- 5, master formulation and all related documents
have been revised as tablets.
Decision: Approved with following label claim:
Pantoprazole ……………….40mg
1433. Name and address of manufacturer/ M/s Invictus Pharmaceuticals, Plot No. 21, 26, Street No.NS-2,
Brand Name + Dosage Form + Strength Trobak Tablet 37.5mg/325 mg
Tramadol HCl………….37.5mg
Paracetamol……………..325mg
th
Pack size & Demanded Price 10’s, 20’s, 30’s & as per SRO
Me-too status Tramadoln Plus Tablet 37.5+325mg of M/s Akson Pharma
085459
Decision: Approved.
1434. Name and address of manufacturer/ M/s Fozan Pharmaceutical, 36-A, Industrial Estate, Hayatabad,
Applicant Peshawar.
Brand Name + Dosage Form + Strength Ether Plus tablet 80/480 mg
Artemether………………………………….80mg
Lumefantrine………………………………480mg
Approval status of product in Reference WHO recommended formulation
Me-too status Artem -DS Plus Tablets 80/480 of M/s Hilton Pharma,
Karachi (Reg.# 066843)
Remarks of the EvaluatorXIII The official monograph for the applied formulation is available
in IP.
Decision: Approved with IP specifications.
Applicant Peshawar.
Brand Name + Dosage Form + Strength Fergan Capsule 40mg
Omeprazole………………………………….40mg
Approval status of product in Reference Losec Capsule 40mg by M/s Astra Zaneca (MHRA
Me-too status Meprascot Capsules 40mg by M/s Scotmann
Pharmaceuticals (Reg. # 028239)
XIII
Remarks of the Evaluator All the data related with pellets is needed.
in USP.
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of supplier
and differential fee in case of import of pellets.
Applicant Peshawar.
Brand Name + Dosage Form + Strength Dexlan capsule 30mg
Dual Delayed Release Pellets of Dexlansoprazole….30mg
Approval status of product in Reference USFDA Approved as delayed release capsules
Regulatory Authorities. (while you have applied as dual delayed release)
Me- too status Could not be confirmed
Remarks of the EvaluatorXIII The applied molecule is on stability.
Me- too status could not be verified.
1437. Name and address of manufacturer/ M/s Genetics Pharmaceuticals Pvt. Ltd, 539-A, Sundar
Applicant Industrial Estate, Raiwind, Lahore.
Brand Name + Dosage Form + Strength Dopark CR tablet 25/100 mg
Composition Each sustained- release tablet contains:
Carbidopa Anhydrous Eq………25mg
Levodopa……………………...100mg
Pharmacological Group Anti- parkinsons
Remarks of the EvaluatorXIII Firm has submitted the following me- too which could not be
verified:
Sinemet extra 50/ 200mg tablet of OBS Pharma Reg. # 070446.
Brand Name + Dosage Form + Strength Dopark CR tablet 50/200 mg
Composition Each sustained- release tablet contains:
Carbidopa Anhydrous Eq………50mg
Levodopa……………………...200mg
Pharmacological Group Anti- parkinsons
Me- too status Sinemet Extra 50/200mg Tablet of M/s OBS Pakistan, Karachi
070446
Brand Name + Dosage Form + Strength Sofair 5mg Tablet
Montelukast as Montelukast Sodium…...………..…5mg
Pharmacological Group Leukotriene receptor antagonist
Approval status of product in Reference Singulair 5mg chewable of (USFDA approved)
Me- too status Lontuka 5mg Chewable Tablet M/s Linz Pharma 058391
Decision: Approved.
Brand Name + Dosage Form + Strength Sofair 10mg Tablet
Montelukast as Montelukast sodium……………...10mg
Pharmacological Group Leukotriene receptor antagonist
Me- too status Montiget 10 mg tablets of M/s Getz Pharma (Reg.# 034838)
XIII
Decision: Approved.
Brand Name + Dosage Form + Strength Retone 50mg Tablet
Itopride HCl……………...50mg
Pharmacological Group Propulsive
Me- too status Ganaton 50mg Tablet by M/s Abbott (Reg. # 028429)
Decision: Approved.
1442. Name and address of manufacturer/ M/s Stallion Pharmaceuticals Pvt Ltd, 581, Sundar Industrial
M/s English Pharmaceutical Industries, Link Kattar Bund Road,
Thokar Niaz Baig, Multan Road, Lahore.
Brand Name + Dosage Form + Strength Tygastin Dry powder for I/V Infusion 5ml
Tigecycline………………………….50mg

Pack size & Demanded Price 50mg/ vial & As per SRO
Me- too status Tygacil Injection 50mg by M/s Wyeth
(Reg. # 045642)
GMP status M/s Stallion:- Not provided
M/s English: - 16-01-2018 and the report concludes grant of
certificate of GMP issued on 16-01-2018.
Remarks of the EvaluatorXIII  No. of sections of applicant needs to be submitted.
 No. of already registered drugs on contract needs to be
submitted.
 The official monograph for the applied drug is available
in USP.
 5% overage justification.
 Clarification is required either it is lyophilised cake or
powder.
 Section approval letter of manufacturer needs to be
submitted.
 GMP report of M/s Stallion Pharma needs to be
 Number of products already approved on contract manufacturing
 Number of approved sections with M/s Stallion Pharmaceuticals, Lahore
 Justification of 5% overage in master formulation
 Confirmation of required manufacturing facility with manufacturer
 Clarification whether applied formulation is lyophilized cake or powder.
1443. Name and address of manufacturer/ M/s Perfect Pharma Pvt Ltd, 5-Km, Manga Road, Raiwind,
Applicant Lahore, Pakistan.
Brand Name + Dosage Form + Strength Kalzole Capsule 20mg
Esomeprazole Magnesium………………….20mg
Pack size & Demanded Price 10 14 100 As per SRO
Approval status of product in Reference MHRA Approved as gastro resistant
Me- too status Esomepral 20 mg Capsules Amson Vaccines & Pharma (Pvt)
Ltd, Islamabad. 043332
report concludes renewal of DML for general tablet and general
capsule section and grant of additional psychotropic tablet
section.
Remarks of the EvaluatorXIII  “As esomeprazole magnesium dehydrate” is approved
in MHRA.
available in USP.
 All the data related to pellets is needed and gastro
resistant capsules are not applied.

 Data related to pellets including source of pellets, COA of pellets, GMP of pellet manufacturer and
stability data of 3 batches of pellets.
Brand Name + Dosage Form + Strength Kalzole Capsule 40mg
Esomeprazole Magnesium………………….40mg
Approval status of product in Reference MHRA Approved as gastro resistant
Me- too status Esomepral 40 mg Capsules Amson Vaccines & Pharma (Pvt)
Ltd, Islamabad. 043333
section.
Remarks of the EvaluatorXIII As esomeprazole magnesium dihydrate is approved in MHRA.
in USP.
All the data related to pellets is needed and gastro resistant
capsules are not applied.
 Data related to pellets including source of pellets, COA of pellets, GMP of pellet manufacturer and
stability data of 3 batches of pellets.
Brand Name + Dosage Form + Strength Kalmus Ointment 0.1% w/w
Tacrolimus………………………………0.001gm
Me- too status Tacrozemus Ointment of M/s Hiranis Pharma
086789
section.
Remarks of the EvaluatorXIII Tacrolimus as monohydrate is approved in MHRA.
The applied formulation is non- pharmacopoeial
Section needs confirmation.
 Revision of label claim as per reference product.
 Cofirmation of required manufacturing facility i.e., Cream / ointment section is required.
Brand Name + Dosage Form + Strength Kalmus Ointment 0.3% w/w
Tacrolimus…0.003gm
Approval status of product in Reference MHRA Approved As monohydrate and in 0.03% w/w strength
Me- too status Tacroderm Ointment 0.03% Caraway Pharmaceuticals, Rawat
069932
section.
Remarks of the EvaluatorXIII MHRA Approved As monohydrate and in 0.03% w/w strength
Section needs confirmation.
 Revision of label claim as per reference product.
 Cofirmation of required manufacturing facility is required.
Brand Name + Dosage Form + Strength Kalgab Capsule 75mg
Pregabalin…..…75mg
Me- too status Pregalax Capsule of M/s Magns Pharmaceuticals, Faisalabad
084136
section.
Remarks of the EvaluatorXIII The applied formulation is non- pharmacopoeial.
General capsule section is available in the firm as mentioned in
Brand Name + Dosage Form + Strength Kalthro Capsule 250mg
Azithromycin Dihydrate………………………….250mg
Pharmacological Group Macrolide Antibiotic
Me- too status Azithromycin 250mg Capsules of M/s Unipharma (Pvt.) Ltd.,
Lahore 071421

section.
in USP.
As dihydrate is approved in reference.
Decision: Deferred as the approved drug in reference regulatory authorities is “Azithromycin as
Dihydrate” while the firm has applied “Azithromycin Dihydrate”.
Brand Name + Dosage Form + Strength Kalthro Capsule 500mg
Azithromycin dihydrate…………………………..500mg
Me- too status Azithromycin 500mg Capsules of M/s Unipharma (Pvt.) Ltd.,
Lahore. 071422
section.
in USP.
As dihydrate will come
Reference could not be confirmed.
 The approved drug in reference regulatory authorities is “Azithromycin as Dihydrate” while
the firm has applied “Azithromycin Dihydrate”.
1450. Name and address of manufacturer/ M/s Caliph Pharmaceuticals Pvt Ltd, Plot # 17, Special
Applicant Industrial Zone, Risalpur, KPK, Pakistan.
Brand Name + Dosage Form + Strength Clobetacal 0.05% w/w Lotion
Composition Each ml lotion contains:
Clobetasol Propionate……………………………..0.05%
Approval status of product in Reference Impeklo Lotion of M/s Mylan0.05% w/w (USFDA Approved
Regulatory Authorities. in bottle with a metered-dose pump having an integral pump
locking feature)
Me- too status Clobeta Topical Solution of M/s Platinum Pharma Karachi
055710

report concludes that the panel recommends the renewal of DML
for following sections:
1- Tablet section (General) (Antibiotic, Non-Antibiotic) 2- Dry
Powder suspension section, General (Antibiotic, Non-
Antibiotic)
3- Capsule section General (Antibiotic, Non-Antibiotic) 4-
Liquid syrup section General (Antibiotic, Non-Antibiotic) 5- QC
6- Warehouses
The panel also unanimously recommends the grant of following
sections as well:
1- Cream/Ointment/Lotion section General (Antibiotic, Non-
Antibiotic)
2- Sachet section, General (Antibiotic, Non-Antibiotic).
Remarks of the EvaluatorXIII  Cream/ Ointment/ Lotion section General (Antibiotic,
Non-Antibiotic) is available in the firm as mentioned in
the submitted section approval letter.
 IMPEKLO™ lotion, 0.05% is a white to off white,
opaque to translucent, homogenous and lump free lotion
without any phase separation provided in a white bottle
with a metered-dose pump having an integral pump
locking feature. Each pump actuation delivers 0.15 mg
of clobetasol propionate, USP in 0.30 g of lotion. The
metered-dose pump is capable of dispensing not less
than 138 actuations to deliver not less than 41.4 g of
lotion.
 Revise label claim as it is not clear that how to make it
0.05%. (If it is 0.5mg/ gram, then it becomes 0.05% of
lotion).
 Mention the container closure system.
 USFDA Approved in bottle with a metered-dose pump
having an integral pump locking feature
 You have applied w/w while in label claim you have
written each ml contains. Explain how?
Decision: Deferred for revision of formulation as per reference product alongwith details of container
closure system.
Brand Name + Dosage Form + Strength Erdocal Sachet 225mg
Composition Each sachet contains:
Erdosteine…………..…225mg
Pharmacological Group Mucolytic
Approval status of product in Reference ANSM; France Approved in 300mg sachet while 225mg is
Regulatory Authorities. applied
Me- too status Mucolec 225 mg Sachet of M/s Wnsfeild Pharmaceutical,
Industrial Estate, Hattar 078593
Antibiotic)

6- Warehouses
sections as well:
Antibiotic)
Remarks of the EvaluatorXIII  General Sachet section is available in the firm as
mentioned in the submitted section approval letter.
 Revise the applied strength as it is ANSM; France
Approved in 300mg sachet while you have applied
225mg.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory authorities
which were adopted by Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength Vigacal 500mg Sachet
Vigabatrin…………....500mg
Me- too status Vlep 500mg Sachet of M/s Genix Pharma (Pvt.) Ltd
Karachi 070474
Antibiotic)
6- Warehouses
sections as well:
Antibiotic)
XIII
Remarks of the Evaluator General Sachet section is available in the firm as mentioned in
Decision: Approved.
Brand Name + Dosage Form + Strength Smectacal Sachet 3g
Dioctahedral Smectite…………………………………3g
Pharmacological Group Anti- diarrhoeal

Me- too status Semetamed 3g Sachet of M/s Mediate Pharmaceutical (Pvt.)
Ltd, Karachi 061925
Antibiotic)
6- Warehouses
sections as well:
Antibiotic)
Remarks of the EvaluatorXIII General Sachet section is available in the firm as mentioned in
1454. Name and address of manufacturer/ M/s Noa Hemis Pharmaceuticals, Plot No. 154, Sector-23, Korangi
Brand Name + Dosage Form + Strength Zitomax capsule 250mg
Azithromycin as Dihydrate eq. to
Azithromycin……………………………...250mg
Pharmacological Group Macrolide antibiotic
Me- too status Zidor capsule 250mg of M/s Winthrox Karachi (Reg.#
074943)
GMP status Last GMP inspection conducted on 20-03-2018., and the
report concludes that the firm was considered to be
operating at an acceptable level of compliance to the cGMP.
Remarks of the EvaluatorXIII  The official monograph is available in USP.
Brand Name + Dosage Form + Strength Somalin Syrup 100mg/ml
Composition Each ml of syrup contains:
Citicoline as Sodium………………………100mg
Pharmacological Group Nootropics and Neutronics
Approval status of product in Reference Approved by AEMPS of Spain
Me- too status Cercolin Syrup of M/s Schazoo Laboratories (Reg.# 048985)

Remarks of the EvaluatorXIII General syrup section is available in the firm as mentioned
in the submitted GMP inspection report.
The applied drug is non- pharmacopoeial.
Brand Name + Dosage Form + Strength Ovatab 50mg Tablet
Clomiphene Citrate…50mg
Pharmacological Group Ovulatory Stimulants
Me- too status Cerophene 50mg Tab of M/s Hilton Pharma
Karachi 010104
Remarks of the EvaluatorXIII  The official monograph is available in USP.
Brand Name + Dosage Form + Strength Migagor Syrup 0.25mg
Pizotifen Hydrogen Malate eq.to Pizotifen..0.25mg
Pharmacological Group Anti- migraine
Approval status of product in Reference Sanomigran Elixir 0.25mg /5ml of M/s Phoenix, (MHRA
Me- too status Pizo Syrup of M/s English Pharmaceutical Industries, Lahore
020337
Remarks of the EvaluatorXIII General syrup section is available in the firm as mentioned
in the submitted GMP inspection report.
The applied drug is non- pharmacopoeial.
Brand Name + Dosage Form + Strength Nurocobal 500mcg Tablet
Composition Each sugar- coated tablet contains:
Mecobalamin…………...500mcg
Pharmacological Group Coenzyme/ Vitamin B-12
Me- too status Mecovit 500mcg Tablet of M/s Zumars Pharma (Pvt.) Ltd
(Reg.# 057709)
Remarks of the EvaluatorXIII The official monograph for the applied formulation is
available in JP.
Decision: Approved with JP specifications.
Brand Name + Dosage Form + Strength Noacip 125mg Suspension
Composition Each 5ml after reconstitution contains:
Pharmacological Group Ant- infective
Me- too status Ciprogat of M/s Miracle Pharma 072366
available in USP.
Reg. board in its 269th DRB meeting decided:
Keeping in view the following statement written in Qualitative
and quantitative composition “2.5 mL suspension after
reconstitution (1/2 measuring spoon) contains 125 mg
ciprofloxacin” and domestic conditions for difficulties in
dispensing 250mg/5ml suspension for children under 2 years of
age, Registration Board decided to approve the formulation of
ciprofloxacin 125mg/5ml granules and solvent for oral
suspension as per reference product approved by USFDA and
MHRA.
Brand Name + Dosage Form + Strength Noacip 250mg Suspension
Me- too status Ciprogat Miracle Pharma 072367
available in USP.
Brand Name + Dosage Form + Strength Ucon Suspension 50mg/5ml powder for oral suspension
Fluconazole…50mg
Approval status of product in Reference MHRA Approved powder for suspension
Me- too status Derocon Suspension Raazee Therapeutics (Pvt) Ltd, 48KM,
Lahore Kasur Road, Kasur. 027219
available in USP.
1462. Name and address of manufacturer/ M/s Wenovo Pharmaceuticals, Plot # 31& 32 Punjab Small
Applicant Industrial Estate, Taxila, Pakistan.
Brand Name + Dosage Form + Strength Wenorol 10mg tablet
Composition Each uncoated tablet contains:
Bambuterol HCl…………………………..…….10mg
Pharmacological Group Long acting beta adreno receptor agonist (drugs for obstructive
airway disease)
Me- too status Bambuzaf tablet of M/s Zafa Pharma 067573
report concludes grant of GMP certificate.
submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Wentowin 10mg capsule
Acitretin…..…..10mg
Pharmacological Group Anti- psoriatic
Me- too status ACT 10mg Capsule Ciba Pharma 081575

Remarks of the EvaluatorXIII General capsule section is available in the firm as mentioned in
the submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Wentowin 25mg capsule
Acitretin……….25mg
Pharmacological Group Anti- psoriatic
Me- too status Acitec 25 mg Capsules Panacea Pharma 069843
XIII
Remarks of the Evaluator General capsule section is available in the firm as mentioned in
the submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Wefex 50mg XR Tablet
Composition Each Extended Release Film Coated Tablet Contains:
Desvenlafaxine Succinate Eq. to Desvenlafaxine…50mg
Me- too status Desven XR 50mg Tablet Pharmevo Kar 080283
submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Wefex 100mg XR Tablet
Composition Each extended - release film- coated tablet contains:
Desvenlafaxine Succinate eq. to Desvenlafaxine.100mg
Finished product Specification innovators
Me- too status Desvel XR 100mg tablet of M/s Hilton Pharma
070760

submitted DML.
Decision: Approved.
Applicant Industrial Estate Taxila Pakistan
Brand Name + Dosage Form + Strength Wastin 1mg Tablet
Pitavastatin Calcium Eq. to Pitavastatin…1mg
Pharmacological Group HMG Co- A reductase Inhibitor
Me- too status Pitastin 1mg Tablet Atco Lab 081095
XIII
submitted DML.
Decision: Approved.
Pitavastatin Calcium Eq. to Pitavastatin………….2mg
Pharmacological Group HMG Co- A Reductase Inhibitor
Me- too status Pitastin 2mg tablet of M/s Atco Lab 081094
submitted DML.
Decision: Approved.
1469. Name and address of manufacturer/ M/s Wenovo Pharmaceuticals., Plot # 31& 32 Punjab Small
Pitavastatin Calcium Eq. to Pitavastatin…4mg
Pharmacological Group HMG Co- A reductase Inhibitor
Me- too status Pitastin 4mg Tablet Atco Lab 081093
submitted DML.

Decision: Approved.
Brand Name + Dosage Form + Strength Wemride 50mg Tablet
Amisulpride…50mg
Me- too status Solium-50 Tablets of Genomen Pharma 064017
submitted DML.
in BP while USP monograph is applied.
Decision: Approved.
Brand Name + Dosage Form + Strength Wemride 100mg tablet
Amisulpride…………………………………….100mg
Me- too status Ampisol 100mg Tablet of M/s Sami Karachi 076061
submitted DML.
Decision: Approved with BP specifications.
Brand Name + Dosage Form + Strength Wemride 200mg Tablet
Amisulpride…200mg
Me- too status Ampisol 100mg Tablet of M/s Sami Karachi 076061

submitted DML.
Brand Name + Dosage Form + Strength Busowen 5mg Tablet
Buspirone HCl……………………………….…...5mg
Pharmacological Group Anxiolytic
Me- too status Buspro Tablet 5mg of M/s Saydon Pharma 080227
submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Busowen 10mg Tablet
Buspirone HCl……………………………..…...10mg
Pharmacological Group Anxiolytic
Me- too status Buspro Tablet 5 mg Saydon Pharma080227
submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Wezovast 10/10 mg Tablet
Ezetimibe………………………………….10mg
Atorvastatin Calcium Eq. to Atorvastatin…10mg
Me- too status Atorax-E Tablets of M/s Dyson Research Laboratories
078838

submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Wezovast 10/20 mg Tablet
Ezetimibe………………………………….10mg
Atorvastatin Calcium Eq. to Atorvastatin…20mg
Me- too status Lipiget EZ 20mg+10mg Tablet of Getz Pharma 073714
submitted DML.
Decision: Approved.
1477. Name and address of manufacturer/ M/s Wenovo Pharmaceuticals, Plot # 31 & 32 Punjab Small
Brand Name + Dosage Form + Strength Welpinde 5/40 mg Tablet
Composition Each bi-layered uncoated tablet contains:
Amlodipine Besylate Eq. to Amlodipine…………5mg
Telmisartan………………………………………40mg
Me- too status Telam 5mg/ 40 mg tablet of M/s Macter International, Kar
(Reg. # 079540)
mentioned in the submitted DML.
available in USP.
 Evidence of required manufacturing equipment i.e.
tablet bi-layered machine and Reports of submission
of Installation Qualification & Performance
Qualification Reports of tablet bi-layered machine.
Decision: Deferred for confirmation of required manufacturing equipment i.e. tablet bilayered
machine by area FID.
Composition Each Bi-Layered Uncoated Tablet Contains:
Telmisartan…80mg
Me- too status Telam 5mg/ 80 mg tablet of M/s Macter International, Karachi
(Reg. # 079541)
available in USP.
Brand Name + Dosage Form + Strength Welpinde 40/10mg Tablet
Composition Each bi-layered uncoated tablet contains:
Amlodipine Besylate Eq. to Amlodipine………..10mg
Telmisartan………………………………………40mg
Me- too status Amtas 10mg + 40mg Tablet of M/s Getz Pharma (Pvt) Ltd
(Reg. # 066945)
available in USP.
Composition Each Bi-Layered Uncoated Tablet Contains:
Telmisartan…80mg
Me- too status Misar-Am 80/10mg Tablet of M/s Highnoon Pharma (Pvt) Ltd
(Reg. # 069151)
available in USP.
Brand Name + Dosage Form + Strength Wolme 5/20 mg Tablet
Amlodipine Besylate Eq. to Amlodipine…………5mg
Olmesartan Medoxomil……………………….…20mg
Me- too status Baritec-A 20/5mg Tablet Barrett Hodgson 081442
Decision: Approved.
Brand Name + Dosage Form + Strength Wolme 5/40 mg Tablet
Amlodipine Besylate Eq. to Amlodipine……….…5mg
Olmesartan Medoxomil………………………..…40mg

Decision: Approved.
Brand Name + Dosage Form + Strength Wolme Tablet 10/ 20mg
Amlodipine Besylate Eq. to Amlodipine……….10mg
Olmesartan Medoxomil…………………………20mg
Decision: Approved.
Brand Name + Dosage Form + Strength Wentowen 24mg tablet
Betahistine Dihydrochloride…………………….24mg
Me- too status Enier 24mg Tablet Sami Pharma 076757
Decision: Approved.
Brand Name + Dosage Form + Strength Wentowen 48mg Tablet
Betahistine Dihydrochloride…48mg
Approval status of product in Reference Could not be confirmed in the applied strength as available
Regulatory Authorities. strengths are 8mg, 16mg and 24mg
Me- too status Statobex 48mg Tablet of M/s Atco Laboratories Limited
058433

 International availability could not be confirmed in the
applied strength as available strengths are 8mg, 16mg
and 24mg.
/ agencies which were adopted by the Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength Wenotin 500mg Tablet
Composition Each film -coated tablet contains:
Vigabatrin……….………500mg
Pharmacological Group antiepileptic
Me- too status Seizril 500mg Tablet of M/s Nabiqasim Kar 081564
Decision: Approved.
Brand Name + Dosage Form + Strength Wenzer 250mg capsule
Cycloserine…..250mg
Me- too status Cyclosen Capsules of M/s Schazoo Laboratories
035272
Decision: Deferred for applied pharmacological group as the applied drug is an Antibiotic and not an
antiepileptic.
Brand Name + Dosage Form + Strength Maxin 50mg Tablet
Naltrexone HCl………….50mg
Pharmacological Group Opioid Antagonist (Drugs used in addictive disorders )

Me- too status E-Track 50mg Tablet of M/s Elko 070791
Decision: Approved.
Applicant Industrial Estate, Taxila, Rawalpindi.
Brand Name + Dosage Form + Strength Wespone 50mg Tablet
Composition Each sugar coated tablet contains:
Eperisone Hydrochloride……………………….50mg
Finished product Specification innovators
Approval status of product in Reference Myonal 50mg tablets (PMDA; Japan Approved)
Me- too status Peson Tablet 50mg of M/s Regal Pharma 081955
Decision: Approved.
Brand Name + Dosage Form + Strength Woxim 20mg Tablet
Tenoxicam….……………20mg
Me- too status Tenoxicam Tablets of M/s Alina Combine 020529
 The applied formulation is available in BP while the
firm has applied USP.
Decision: Approved.
Brand Name + Dosage Form + Strength Febux tablet 120mg
Febuxostat Dihydrochloride...………...……120mg
Pharmacological Group Preparations inhibiting uric acid production
Me- too status Febustat Tablet of M/s Wimits Pharma 086278
Remarks of the EvaluatorXIII • General tablet section is available in the firm as
• The applied formulation is non- pharmacopoeial.
• Initially, in applied master formulation Tfebuxzidine
Dihydrochloride was mentioned while in Form- 5
Febuxostat was written. On fee-challan only brand name
is mentioned.
• Now, the firm has revised its Form- 5 and master
formulation as Febuxostat and has submitted 20,000
fees for new application.
Brand Name + Dosage Form + Strength Wemarox 85/500 mg Tablet
Sumatriptan Succinate Eq. to Sumatriptan……...85mg
Naproxen Sodium………………………………500mg
Pharmacological Group Selective 5 HT1 receptor agonist
Approval status of product in Reference Approved in TGA; Australia as film- coated
Me- too status Imtaxen Tablet of M/s Shaigan Pharma 081678
• Initiallly, it was applied as uncoated while is approved
in TGA; Australia as film- coated.
• Firm has revised the formulation according to the
reference and has submitted the requisite fees for
revision of formulation as Rs. 5000/- under deposit slip
# 2045302 dated 10-07-2020.
Brand Name + Dosage Form + Strength Wencolin 100mg Tablet
Minocycline Hydrochloride eq. to Minocyclin...100mg
Pharmacological Group Tetracycline Antibiotic
Me- too status Minoderm tablets of M/s Martin Dow Pharma 024308

• Initially, on Form- 5, 100mg was written and on fee-
challan 500mg was mentioned. While in composition
400mg was applied.
• Firm has revised the strength from 500mg to 100mg and
has deposited Rs. 20,000/- fees under deposit slip #
2045304 dated: 10-07-2020.
Decision: Deferred for the applied strength as initially, on Form- 5, 100mg was written and on fee-
challan 500mg was mentioned. While in composition 400mg was applied.
Brand Name + Dosage Form + Strength Wetrole Capsule 100mg
Itraconazole as IR Pellets ……………………..100mg
Finished product Specification Innovators’ specifications
Me- too status Zitracon Capsules 100mg of M/s Meditech Pharma 073346
Remarks of the EvaluatorXIII • General capsule section is available in the firm as
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of supplier
and differential fee in case of import of pellets.
1495. Name and address of manufacturer/ M/s Glitz Pharma, Plot No 2610. Industrial Triangle,
Applicant Kahuta Road, Islamabad.
Brand Name + Dosage Form + Strength Esglit tablet 5mg
Escitalopram Oxalate Eq. to Escitalopram…............5mg
Pack size & Demanded Price 10's, 20's, 14's, 50's, 100's & As per SRO
Me- too status Rize- plus tablet 5 mg of M/s Werrick Pharmaceuticals
Islamabad (Reg.# 068875)
GMP status The firm was inspected on 16.01.2019. The panel recommended
the grant of GMP certificate.
Remarks of the EvaluatorXIII  Methylene chloride has been used in the applied
coating solution.
 Firm has general tablet section as mentioned in the
Decision: Deferred as a banned excipient Methylene chloride has been used in the applied coating
solution.
1496. Name and address of manufacturer/ M/s Evolution Pharmaceuticals pvt Ltd, Plot no 25 & 26, Street
Applicant S- 3., RCCI Industrial Estate Rawat.
Brand Name + Dosage Form + Strength Diabex tablet1000mg
Metformin HCl……….1000mg
Pack size & Demanded Price 10's, 20's, 30's, 50's & As per SRO
Approval status of product in Reference 1. ANSM; France Approved
Me- too status Glucophage Tablets 1Gm Merck Marker (Pvt.) Ltd, 7-Jail
Road, Quetta 025488
report concludes:
Recommendations: As the operations have not started as of yet
at M/s Evolution Pharmaceuticals, Rawat GMP status can only
be ascertained upon the start of active production, however:
Keeping in view the facility inspected the firm has requisite for
manufacturing of pharmaceuticals.
XIII
Remarks of the Evaluator The official monograph for the applied product is available in
USP.
1497. Name and address of manufacturer/ M/s Evolution Pharmaceuticals pvt Ltd, Plot no 25 & 26, Street
Applicant S- 3., RCCI Industrial Estate Rawat.
Brand Name + Dosage Form + Strength Itrosac Capsules 100mg
Itraconazole…………………………………...…100mg
Pharmacological Group Anti-fungal
Me- too status Mukil Capsule 100mg of M/s. Dyson Research Laboratories
(Pvt.) Ltd (Reg.# 055356)
report concludes:
Recommendations: As the operations have not started as of yet
at M/s Evolution Pharmaceuticals, Rawat GMP status can only
be ascertained upon the start of active production, however:
Keeping in view the facility inspected the firm has requisite for
manufacturing of pharmaceuticals.
Remarks of the EvaluatorXIII Source of pellets is M/s Vision Pharmaceuticals, Kahuta Road,
Islamabad and data related to pellets is submitted.
Decision: Approved.
1498. Name and address of manufacturer/ M/s Horizon Healthcare (Pvt.) Ltd, Plot# 33, Sunder Industrial
Brand Name + Dosage Form + Strength Irbest 150mg tablet
Irbesartan…………….…150mg
Me- too status Arbi 150mg Tablet of M/s Pharm Evo (Reg.# 073769)
 Tablet general section is available in the firm as
available in USP.
1499. Name and address of manufacturer/ M/s Horizon Healthcare (Pvt.) Ltd, Plot# 33, Sunder Industrial
Brand Name + Dosage Form + Strength Irbest 300mg Tablet
Irbesartan………………300mg
Me- too status Irecon 300mg tablet of M/s Barrett Hodgson (Reg.# 039727)
Remarks of the EvaluatorXIII  Tablet general section is available in the firm as
available in USP.
1500. Name and address of manufacturer/ M/s Horizon Healthcare (Pvt) Ltd, Plot# 33, Sunder Industrial
Brand Name + Dosage Form + Strength Irbest-H Tablet150/12.5 mg
Irbesartan……………….150mg
Hydrochlorothiazide…...12.5mg
Pharmacological Group Anti- hypertensive/ Diuretic
Pack size & Demanded Price 10 30 & as per SRO
Me- too status Irbest Plus tablet of M/s Highnoon (Reg. # 077110)
available in USP.
Brand Name + Dosage Form + Strength Irbest-H Tablet300/12.5 mg
Irbesartan………………300mg
Hydrochlorothiazide…..12.5mg

Pack size & Demanded Price 10’s, 30’s & as per SRO
Me- too status Irbest Plus Tabletsof M/s Highnoon Laboratories, Lahore
077111
available in USP.
Brand Name + Dosage Form + Strength Lewdes 0.5mg Oral Syrup
Desloratadine…………………………………0.5mg
Pack size & Demanded Price 60ml & as per SRO
Approval status of product in Reference Aerius for Children Syrup desloratadine 2.5mg/5ml oral liquid
Regulatory Authorities TGA; Australia Approved
Me- too status Mdisin 2.5mg Syrup M/s Metro Pharmaceuticals,
Islamabad081671
Remarks of the EvaluatorXIII  Oral liquid general section is available in the firm as
available in USP.
1503. Name and address of manufacturer/ M/s Karachi Pharmaceutical Laboratories, S/ 54, Mauripur
Applicant Road, SITE, Karachi.
Brand Name + Dosage Form + Strength Calm tablet 1mg
Alprazolam…..1mg
Pharmacological Group Anxiolytic agent Antidepressant
Approval status of product in Reference Xanax 1mg by M/s Pharmacia and UpJohns, USFDA
Me- too status Lydia 1mg Tablet of M/s. Wilshire LabReg. 065699
Remarks of the EvaluatorXIII  GMP report is not submitted.
 Confirmation of required manufacturing facility /section from Licensing Division.

firm.
1504. Name and address of manufacturer/ M/s Next Pharmaceutical Products Private Limited, Plot No. 44 A-
Applicant B, Sundar Industrial Estate, Lahore.
Brand Name + Dosage Form + Strength Emapaglif- M tablet12.5/500mg
Empagliflozin…….….…12.5mg
Metformin HCl…………500mg
XIII
Remarks of the Evaluator Stability data is required for this applied molecule along with
submission of differential fees.
Decision: Deferred for submission of stability data as per requirement determined in 293rd meeting
of Registration Board.
1505. Name and address of manufacturer/ M/s Zephyr Pharmatec Pvt. Ltd, Plot No. A-39, S.I.T.E II,
Applicant Super Highway, Karachi.
Brand Name + Dosage Form + Strength Birone tablet 5mg
Buspirone HCl ………………..……………………5mg
Pharmacological Group Benzodiazepines (Anxiolytic)
Pack size & Demanded Price 30’s & as per SRO
Me- too status Busron 5mg Tablets of M/s SJ & G Fazul Ellahie (Pvt.) Ltd,
Karachi 020564
report concludes that the GMP compliance of the firm is rated as
good.
XIII
Decision: Approved.
Brand Name + Dosage Form + Strength Zefigesic 200mg Tablet
Composition Each film-coated oral tablet contains:
Dexibuprofen…….………….200mg
Me- too status Dofen 200mg Tablet of Maple Pharmaceuticals Karachi
061139

good.
Decision: Approved.
1507. Name and address of manufacturer/ M/s Epla Laboratories, D-12, Estate Avenue, S.I.T.E., Karachi.
Applicant
Brand Name + Dosage Form + Strength Myconit-V Cream
Composition Each gm contains:
Miconazole Nitrate…………………………………20mg
Diary No. Date of R & I & fee Dy.No.5899 dated 11-02-2019, Rs.20,000/- Dated 11-02-2019
Type of Form Form-5
Me- too status Gynostin Cream of M/s Bloom Pharmaceuticals Hattar 025468
available in BP.
 General Ointment/ Cream section is available in the firm
as mentioned in the submitted section approval letter.
Decision: Deferred for confirmation of already of registered formulation for M/s Epla Laboratories,
Karachi.
Applicant
Brand Name + Dosage Form + Strength Myconit Clin-V Cream
Composition Each gram cream contains:
Clindamycin Phosphate……………….….………20mg
Diary No. Date of R & I & fee Dy.No.5901 dated 11-02-2019, Rs.20,000/- Dated 11-02-2019
Me- too status Clindanor 2 % Cream of M/s Nortech Pharma Islamabad
077982
available in USP.
Karachi.
Applicant
Brand Name + Dosage Form + Strength Myconit Oral Gel
Miconazole………………………………………...20mg

Me- too status Miconal 2% Gel of M/s Ciba Pharmaceuticals, Karachi 081513
available in BP.
Karachi.
Brand Name + Dosage Form + Strength Cynova 10mg Tablet
Leflunomide…..……....…10mg
Me- too status Lefonate tablets 10mg of M/s Fassgen Pharmaceuticals (Reg. #
070350)
good.
Decision: Approved.
Brand Name + Dosage Form + Strength Urifix 5mg Tablets
Solifenacin succinate………5mg
Pharmacological Group Anti- spasmodic
Me- too status Solifen 5mg Tablet of Getz Pharma Karachi 061202
good.
XIII
Remarks of the Evaluator Non- pharmacopoeial.
Brand Name + Dosage Form + Strength Urifix 10mg Tablets
Solifenacin succinate….…10mg

Me- too status Solifen Tablet 10mg of M/s Getz Pharma 061203
good.
XIII
Remarks of the Evaluator Non- phramacopoeial.
Brand Name + Dosage Form + Strength Agotin 25mg Tablet
Agomelatine………………25mg
Pack size & Demanded Price 7’s, 10’s, 14’s, 28’s& as per SRO
Approval status of product in Reference TGA, Australia Approved
Me- too status Valdoxan tablet 25mg of M/s Servier (Reg. # 078160)
good.
XIII
Remarks of the Evaluator Non- phramacopoeial.
Brand Name + Dosage Form + Strength Globigen 100mg chewable tablet
Iron- III Hydroxide Polymaltose Complex eq. to elemental
iron……………………………100mg
Pharmacological Group Anti- Anaemic
Approval status of product in Reference Not applicable
Me- too status Misleri Tablets 100 mg of Ambrosia Pharma Industrial Zone,
Rawat 069974
submitted DML.
Brand Name + Dosage Form + Strength Neolepra 5mg Tablet
Olanzapine…………………5mg

Pack size & Demanded Price 7’s, 10’s, 14’s, 28’s& As per SRO
Me- too status Olanzapine-Sandoz 5mg Tablets of M/s Novartis Pharma,
submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Neolepra 7.5mg Tablet
Olanzapine………………7.5mg
Me- too status Olzar of Bryon 068323
submitted DML.
Decision: Approved.
Brand Name + Dosage Form + Strength Neolepra 10mg Tablet
Olanzapine……………….10mg
Me- too status Olanzpine 10 mg Tablets of M/s Akson Pharmaceuticals Pvt
Ltd. Mirpur (Reg.#081661)
submitted DML.
Decision: Approved.
1518. Name and address of manufacturer/ M/s Uni- Tiech Pharmaceuticals, Plot # 4/116, Sec- 21, Korangi
Applicant Industrial Area Karachi.
Brand Name + Dosage Form + Strength Unimate 200mg Tablet
Topiramate………………200mg
th
Me-too status Topirax Tablets 200mg of M/sFeroza International Pharma
(Pvt.) Ltd, Lahore 041657
report concludes show-cause Notice/ Suspension of Production
Orders issued on 21st May, 2019.
 Production of the firm is suspended from 21st May,
2019.
 Section needs to be confirmed.
available in USP.
Brand Name + Dosage Form + Strength Tec- cedol Tablet 325/37.5mg
Paracetamol…………….325mg
Tramadol HCl……….…37.5mg
Me-too status Tramadoln Plus Tablet 37.5+325mg of M/s Akson Pharma
Azad Kashmir 085459
XIII
Remarks of the Evaluator TGA; Australia Approved as film-coated
in USP.
2019.
Brand Name + Dosage Form + Strength Lamotech 50mg Tablet
Lacosamide………………50mg
Me-too status Lacosbar 50mg Tablet of Barrett Hodgson Kar 083224

 Production of the firm is suspended from 21stMay, 2019.
 Non- pharmacopoeial.
Brand Name + Dosage Form + Strength Lamotech 100mg Tablet
Lacosamide…………...…100mg
Me-too status Lacosbar 100mg Tablet of Barrett Hodgson Kar 083223
Remarks of the EvaluatorXIII  Production of the firm is suspended from 21st May,
2019.
Brand Name + Dosage Form + Strength Unizapine Tablet 30mg
Mirtazapine……………….30mg
Me-too status Mirtazep Tablets of M/s Zafa Pharmaceuticals Laboratories
Industrial Area Karachi 024216
 The official monograph is available in BP.
2019.
Brand Name + Dosage Form + Strength Unizapine 45mg Tablet
Mirtazipine………………..45mg

Me-too status Remeron Tablets 45mg of M/s Organon Pakistan Karachi
026398
XIII
Remarks of the Evaluator The official monograph is available in BP.
2019.
Brand Name + Dosage Form + Strength Uninox 200mg/5ml DS Suspension
Cefixime trihydrate ……..……………………..200mg
Me-too status Megnett DS Oral Suspension of S.J. & G Fazul Ellahie (Pvt.)
Ltd, E-46, SITE, Karachi 024000
2019.
 As trihydrate will come
Brand Name + Dosage Form + Strength Ulanza Tablet 5mg
Olanzapine……………...…5mg
Karachi 048411
XIII
th
2019.
Brand Name + Dosage Form + Strength Ulanza 10mg Tablet
Olanzapine……………….10mg
Karachi 048412
XIII
2019.
1527. Name and address of manufacturer/ M/s Unitiech Pharmaceuticals, Plot # 4/116, Sec- 21, Korangi
Brand Name + Dosage Form + Strength Unitropide 150mg Capsule
Itopride HCl SR pellets……………………...…150mg
2019.
 Reference and me- too could not be confirmed.
Brand Name + Dosage Form + Strength Lumisuag 40/240mg Tablet
Artemether………………………………………40mg
Lumefantrine…………………………………..240mg

Approval status of product in Reference WHO recommended formulation as uncoated tablet
Me-too status Artemef Fort Tablet 40/240mg of M/s Panacea
Pharmaceuticals Rawat, Islamabad 056334
2019.
 Coating process is mentioned in the manufacturing
outline but not in master formulation.
 Product is in International pharmacopoeia.
Brand Name + Dosage Form + Strength Sardipine Tablet 5/80mg
Amlodipine Besylate .…………………………….5mg
Valsartan………………………………………...80mg
Pharmacological Group Angiotensin-II receptor blocker/ Calcium channel blocker
Me-too status Amlodine Tablet 5/80 of M/s Jupiter Pharma, Rawat Islamabad
081931
 As besylate would come
2019.
available in USP.
1530. Name and address of manufacturer/ M/s Uni Tiech Pharmaceuticals, Plot # 4/116, Sec- 21, Korangi
Brand Name + Dosage Form + Strength Sardipine 10/160mg Tablet
Amlodipine…10mg
Valsartan…160mg
Pharmacological Group Angiotensin II receptor blocker/ Calcium channel blocker
Me-too status Amlodine Tablet 10/ 160 of M/s Jupiter Pharma Plot # 25, St#
S6 RCCI, Rawat Islamabad 081933
th
2019.
available in USP.
Brand Name + Dosage Form + Strength Respiritech 3mg Tablet
Risperidone………………..3mg

Me-too status Risperin Tablet of M/s Hansel Pharmaceuticals, Lahore 041348
XIII
Remarks of the Evaluator The official monograph is available in USP.
2019.
Brand Name + Dosage Form + Strength Respiritech 4mg Tablet
Risperidone…………….…..4mg
Me-too status Risperidone- Sandoz 4mg Tablet of M/s Novartis Pharma,
Karachi Pakistan 048834
XIII
Remarks of the Evaluator The official monograph is available in USP.
2019.
Brand Name + Dosage Form + Strength Dicflake 100mg SR Tablet

Composition Each film- coated SR tablet contains:
Diclofenac Sodium…………………………….100mg
Me-too status Konac SR Tablets of M/s Remington Pharmaceutical
Industries, Lahore 020535
2019.
Brand Name + Dosage Form + Strength Alfatech 0.5mcg Tablet
Alfacalcidol…………………………………...0.5mcg
Pharmacological Group Vitamin D and Analogue
Approval status of product in Reference PMDA; Japan Approved
Me-too status Alfacal Tablet of M/s Platinum Pharmaceuticals (Pvt.) Ltd,
Karachi 026683
2019.
 Coating process is mentioned in the manufacturing
outline but not in master formulation. While the applied
tablet is uncoated in reference and in Form- 5 it is
written correct.
Brand Name + Dosage Form + Strength Drotech Injection 40mg/2ml
Drotaverine HCl…………………………………40mg
Pharmacological Group Anesthetic
Approval status of product in Reference NO- SPA 40 mg solution for injection by Sanofi Aventis
Regulatory Authorities. (OGYEI Hungary Approved) & NO-SPA 40 mg / 2 ml solution
for injection by Sanofi Romania (NAMMD Romania
Approved)
Me-too status Spastop 40mg/2ml of City Pharma, Karachi 075840
2019.
Brand Name + Dosage Form + Strength Acetech Tablet 100mg
Aceclofenac……………..100mg
Me-too status Aceclo Tablet of M/s Allied Medical Supplies (Pvt.) Ltd.
Karachi 061822
2019.
Brand Name + Dosage Form + Strength Esitech 20mg Tablet
Escitalopram Oxalate………………………….....20mg
Pharmacological Group SSRIs/ Anti- depressant
Me-too status Safepram of Martin Dow
2019.
 Escitalopram as Oxalate is approved in MHRA.
Brand Name + Dosage Form + Strength Unimotrigine 5mg Tablet
Lamotrigine……………….5mg

Approval status of product in Reference USFDA Approved as chewable tablet
Me-too status Lamictal of M/s GSK
2019.
 USFDA Approved as chewable tablet.
Brand Name + Dosage Form + Strength Unimotrigine 200mg Tablet
Lamotrigine………………………………….…200mg
Approval status of product in Reference USFDA Approved as orally disintegrating tablets
Me-too status Could not be confirmed in the applied strength
2019.
available in BP.
 USFDA Approved as orally disintegrating tablets
 Me- too status could not be confirmed in the applied
strength.
Brand Name + Dosage Form + Strength Uniyetine 25mg CR Tablet
Composition Each enteric, film-coated & controlled- release tablet contains:
Paroxetine…………………………………………25mg
Me-too status Paroxin CR Tablets of M/s Shrooq Pharmaceuticals (Pvt) Ltd,
Lahore 060470

2019.
available in USP.
Brand Name + Dosage Form + Strength Unitram 100mg Capsule
Composition Each SR capsule contains:
Tramadol HCl…...100mg
Me-too status Zultra SR 100mg M/s Wilshire Laboratories (Pvt.) Ltd;
Lahore 080714
 Source of pellets and all the data related to pellets is
needed.
2019.
Brand Name + Dosage Form + Strength Unitram Injection 100mg/2ml
Tramadol………………………………………100mg
Pack size & Demanded Price 2mlx 5’s &As per SRO
Approval status of product in Reference TGA; Australia Approved as Ampoule
Me-too status Trauma-Nil 100mg Injection of M/s Global Pharmaceuticals,
Industrial Area, Islamabad 026987
2019.
 HCl is approved in reference.
 Ampoule or vial.

Brand Name + Dosage Form + Strength Uni Cyan 500mcg/ml Injection
Cyanocobalamin……………………………….500mcg
Approval status of product in Reference Could not be confirmed in the applied strength (1mg/ ml is
Regulatory Authorities. available in USFDA while applied one is 0.5mg/ml)
Me-too status Cyanocobalamin Inj of M/s Multi Pharma Lahore 013207
2019.
According to DRB meeting 292nd:
Clarification is required from Licensing Division regarding
approval of required manufacturing facility &
manufacturing equipment for applied drug product.
Clarification is required from firm regarding method used
for sterilization of applied drug product.
Reference could not be confirmed in the applied strength.
Brand Name + Dosage Form + Strength Uni Cyan 1000mcg/2ml Injection
Cyanocobalamin…………………………….1000mcg
Approval status of product in Reference Could not be confirmed in the applied strength (1mg/ ml is
Regulatory Authorities. available in USFDA while applied one is 0.5mg/ml)
Me-too status Cyanocobalamin Inj of M/s Multi Pharma Lahore 013207
2019.
According to DRB meeting 292nd:
Clarification is required from Licensing Division regarding
approval of required manufacturing facility &
manufacturing equipment for applied drug product.
Clarification is required from firm regarding method used
for sterilization of applied drug product.
Reference could not be confirmed in the applied strength.
Brand Name + Dosage Form + Strength Cipflke 125mg/ml Suspension
Ciprofloxacin as lactate………………………..125mg
Approval status of product in Reference Not available as 125mg/5ml suspension but already
Regulatory Authorities. approved by Registration Board based on domestic needs,
dosage for children and its stated quantitative
composition in SmPC.
Me-too status Hiflox 125mg/5ml Dry Suspension of Hilton Pharma
(Reg. # 067498)
 Source of granules needs to be submitted.
2019.
 DRB in its 290th meeting approved the case with
innovators’ specifications. With the condition that
diluent shall be as per innovators’
composition.
Brand Name + Dosage Form + Strength Cipflke 250mg/ml Suspension
Ciprofloxacin as lactate………………………..250mg
Pack size & Demanded Price 1x 60ml & As per SRO
Me-too status Ciprofoz Dry Suspension 250mg of M/s Fozan
Pharmaceuticals Industries (Pvt.)Ltd, Hayatabad, Peshawar
064463
2019.
1547. Name and address of manufacturer/ M/s Welmark Pharmaceuticals, Plot. No. 122, Block B, Phase V,
Applicant Industrial Estate, Hattar, KPK.
Brand Name + Dosage Form + Strength Linamethyst Tablet
Linagliptin………………….2.5mg
Metformin HCl…………….500mg
Type of Form Form-5
Finished product Specification Manufactures
GMP status Last GMP inspection was conducted on 04-09-2018 & 26-
09-2018 and report concludes the renewal of DML.
Remarks of the EvaluatorXIII Non- pharmacopoeial.
Me- too could not be confirmed.
Brand Name + Dosage Form + Strength Linajenta 5mg Tablet
Linagliptin……………………5mg
Diary No. Date of R & I & fee Dy.No.16474 dated 07-03-2019 Rs.20,000/- Dated 06-03
-2019
Type of Form Form-5
Brand Name + Dosage Form + Strength Vortex 10mg Tablet
Vortioxetine Hydrobromide..10mg
Type of Form Form-5
Brand Name + Dosage Form + Strength Cilinem 500/500 mg Injection
Imipenem Monohydrate……………………..…500mg
Cilastatin Sodium……………………………….500mg
Type of Form Form-5
Me-too status Stanem Injection 500mg of M/s Cirin Pham. (Pvt.) Ltd., Hattar
069743
in USP.
I/M or I/V?
Applied volume?
Brand Name + Dosage Form + Strength Ertamark 1g Dry Injection I/V
Ertapenem……..1g
Type of Form Form-5
Approval status of product in Reference USFDA Approved as lyophilized powder
Me-too status Invanz Injection 1g of M/s Muller & Phipps Pakistan (Pvt.)
Ltd., Karachi 043051
USFDA Approved as lyophilized powder
Brand Name + Dosage Form + Strength Meromark 500mg Dry Injection I/V
Meropenem Trihydrate Eq. to Meropenem……500mg
Type of Form Form-5
Me-too status Merem of M/s Global Pharmaceuticals 038073
in USP.
Brand Name + Dosage Form + Strength Calcet 60mg Tablet
Cinacalcet HCl……………...60mg
Pharmacological Group Anti- parathyroid agent
Type of Form Form-5
Brand Name + Dosage Form + Strength Aziltan 20mg Tablet
Azilisartan Medoxomil as Potassium…………...20mg
Pharmacological Group Angiotensin- II Receptor blocker
Type of Form Form-5
Brand Name + Dosage Form + Strength Alup 12.5mg Tablet
Alogliptin Benzoate………12.5mg
Type of Form Form-5
Me- too could not be confirmed
Brand Name + Dosage Form + Strength Diazep 10mg Tablet
Diazepam……..10mg
Type of Form Form-5

Me-too status Diazepam 10mg Tab of M/s Star Labs Lahore 005619
XIII
Brand Name + Dosage Form + Strength Cilinem 250/250 mg Injection
Imipenem Monohydrate…250mg
Cilastatin Sodium…250mg
Type of Form Form-5
Me-too status Cilapen 250mg Injections of M/s Bosch Pharmaceuticals,
048490
in USP.
I/M or I/V?
Applied volume?
Brand Name + Dosage Form + Strength Clon 2mg Tablet
Clonazepam…...2mg
Type of Form Form-5
Me-too status Clonatril Tablet of M/s Polyfine Chempharma, Peshawar
024098
Brand Name + Dosage Form + Strength Alap 0.5mg Tablet
Alprazolam…0.5mg
Type of Form Form-5
Me-too status Alprazolam 0.5 mg Tablets of M/s Heal Pharma Peshawar,
079391
in USP.
Brand Name + Dosage Form + Strength Meromark 1g Dry Injection I/V
Meropenem Trihydrate Eq. to Meropenem…1g
Type of Form Form-5
Me-too status Meronem I.V Injection 1gm of M/s ICI Pakistan Ltd Karachi
018548
XIII
Remarks of the Evaluator Non- pharmacopoeial.
Brand Name + Dosage Form + Strength Vortex 20mg Tablet
Vortioxetine Hydrobromide…20mg
Type of Form Form-5
1562. Name and address of manufacturer/ "M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Applicant Estate, Lahore"
Brand Name + Dosage Form + Strength Mentine 10mg Tablet
Memantine HCl…10mg”
Diary No. Date of R & I & fee Dy. No 10887 dated 05-03-2019 Rs.50,000 Dated 05-03-2019
Pharmacological Group Psychoanaleptics
Type of Form Form-5
Me-too status Namentec 10mg Tablet of M/s Pharmatech Karachi (Reg.#
075937)
GMP status GMP certificate based on evaluation conducted in February
2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Bonst 70mg Tablet
Composition "Each Tablet Contains:
Alendronate as Sodium eq. to Alendronate acid……70mg"
Diary No. Date of R & I & fee Dy. No 10920 dated 05-03-2019 Rs.20,000/- Dated 04-03-
2019
Pharmacological Group Bisphosphonates
Type of Form Form-5
Me-too status Ostim Tablets of M/s. Genome Pharmaceuticals (Pvt.) Ltd
(Reg.# 054917)
2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Fluzene 5mg Tablet
Levocetirizine dihydrate….…5mg”
2019
Pharmacological Group Antihistamine.
Type of Form Form-5
Me-too status Invocet tablet by M/s Aries Pharma (Reg.#078437)
2020.
XIII
Decision: Approved.
Brand Name + Dosage Form + Strength Urox 500mg Capsule
Composition "Each Capsule Contains:
Ursodeoxycholic Acid…500mg"
2019
Pharmacological Group Anticholelithic
Type of Form Form 5
Approval status of product in Reference Approved by Sweden
Me-too status Urso Capsule 500mg by M/s AGP Karachi. (Reg#070853)
2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Tacroz Capsule 0.5mg
Tacrolimus…….0.5mg"
2019
Type of Form Form-5
Approval status of product in Reference Approved by USFDA
Me-too status Inograf 0.5 mg capsule by Platinum Pharma (Reg.# 045490)
2020.
XIII
Brand Name + Dosage Form + Strength Fluzene 2.5mg/5ml Oral Syrup
Levocetirizine dihydrate…2.5mg
Diary No. Date of R & I & fee Dy. No 10864 dated 05-03-2019, Rs.20,000/- Dated 04-03-
2019
Pharmacological Group Antihistamine.
Type of Form Form-5
Finished product Specification Manufacturer specifications
Me-too status Concidol- L Syrup of M/s Convell Laboratories (Reg.#079350)
2020.
Brand Name + Dosage Form + Strength CHR 500mg/5ml Syrup
Composition "Each 5ml contains:
Chloral hydrate……500mg"
Diary No. Date of R & I & fee Dy. No 10871 dated 05-03-2019, Rs.20,000/- Dated 04-03-
2019
Pharmacological Group Sedatives and Hypnotics
Type of Form Form-5
Approval status of product in Reference Approved by Health Canada
Me-too status Cedate Syrup 500mg of Xenon Pharma

2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Hyline 30/0.98/8/32mg/5ml Syrup
Ammonium chloride……30mg
Menthol…………….....0.98mg
Diphenhydramine……..…8mg
Aminophylline……….…32mg
2019
Pharmacological Group Anti-tussive
Type of Form Form-5
Finished product Specification Mfg. Specs
Approval status of product in Reference Not verifiable
Me-too status Reg.#073704 Adalin Syrup Sugar Free of M/s Macter, F-216,
Karachi
2020.
Brand Name + Dosage Form + Strength Irinik suspension 100/15mg per 5ml
Ibuprofen…………….…100mg
Pseudoephedrine HCl……15mg
Diary No. Date of R & I & fee Dy. No 10875 dated 05-03-2019 Rs.20,000/- Dated 04-03-2019
Pharmacological Group Analgesic and nasal decongestant
Type of Form Form-5
Finished product Specification Mfg. Specs
Approval status of product in Reference Children's Advil Cold suspension by M/s Pfizer (Approved by
Regulatory Authorities. USFDA)
Me-too status Arinac Suspension 100mg/15mg/5ml by M/s Abbott Pharma,
Reg. No. 22353
2020.
Brand Name + Dosage Form + Strength Priso 800mg Tablet
Mesalamine………………...800mg
Pharmacological Group Intestinal anti-inflammatory agents
Type of Form Form-5

Me-too status Mesal 800mg Tablet of M/s Highnoon Labs (Reg.#081380)
2020.
XIII
Decision: Approved.
Brand Name + Dosage Form + Strength Exelon 6mg Capsule
Rivastigmine as hydrogen tartrate…….6mg
2019
Pharmacological Group Acetylcholinesterase inhibitor
Type of Form Form-5
Me-too status Riveme 6mg Capsule of M/s Genix Karachi (Reg.#079954)
2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Japtin 300mg Capsule
Gabapentin…….300mg
2019
Type of Form Form-5
Me-too status Gababion 300mg Capsules of M/s Merck Marker, Karachi
(Reg.#045346)
2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Lopium 50mg Tablet
Losartan Potassium………...50mg
2019
Pharmacological Group Angiotensin- II Receptor Blocker
Type of Form Form-5
Me-too status Pixan- 50 tablet of M/s Medipak Ltd, Lahore (Reg. # 023944)
2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Eplran 25mg Tablet
Eplerenone…………………25mg
Pharmacological Group Aldosterone antagonists
Type of Form Form-5
Me-too status Cardise 25mg Tablet of M/s Nabiqasim Karachi (Reg.#
081037)
2020.
Decision: Deferred for confirmation of approved manufacturing facility for steroidal tablet section.
Applicant Estate, Lahore
Contract manufacturing by
Road, Islamabad"
Brand Name + Dosage Form + Strength Spasgo 40/0.04 mg Injection
Phloroglucinol hydrate 40mg eq. to anhydrous Phloroglucinol
……………………. 31.12 mg
Trimethylphloroglucinol…………..…0.04mg
Type of Form Form-5
Approval status of product in Reference Spasfon, Solution for Injection in Ampoule by M/S Teva
Regulatory Authorities. Health, (ANSM Approved)
Me-too status Spasfon Injection 4ml by M/s Himont (Reg. # 018530)
GMP status Bio-Mark: GMP certificate based on evaluation conducted in
February 2020.
Bio-Lab: 18 & 23-04-2019 concluding GMP compliant status
Remarks of the EvaluatorXIII M/s Bio Mark has 5 approved sections and 13 products
registered for contract manufacturing.
contract manufacturing by
M/s Dyson Research Laboratories Pvt Ltd. 28 km Ferozepur
Road Lahore"
Brand Name + Dosage Form + Strength Biosteron 10mg Tablet
Dydrogesterone………….…10mg"
Pharmacological Group Progestogens
Type of Form Form-5
Approval status of product in Reference Duphaston by BGP Products (Swissmedic Approved)
Me-too status Duphaston by Abbott (Reg. No. 006654)
GMP status M/s Dyson Research Laboratories: GMP certificate issued on
the base of inspection conducted on 11-01-2019.
M/s Bio Mark Pharma: GMP certificate based on evaluation
conducted in February 2020.
Remarks of the EvaluatorXIII  M/s Dyson Research Laboratories has approved Tablet
Hormone section
 M/s Bio Mark has 5 approved sections and 13 products
Applicant Estate, Lahore contract manufacturing by
Road Lahore"
Brand Name + Dosage Form + Strength Broceton E2 3mg Tablet
Composition "Each Vaginal Tablet Contains:
Dinoprostone…………….3mg"
Pharmacological Group Prostaglandins
Type of Form Form-5
Finished product Specification Mfg. specs
Me-too status Preg-E2 Tablets by Werrick (Reg. No. 040659)
Remarks of the EvaluatorXIII  M/s Dyson Research Laboratories has approved Tablet
Hormone section.
 Applied pharmacological group.
 Confirmation of required manufacturing facility / section from Licensing Division.
Applicant Estate, Lahore contract manufacturing by
Road Lahore"
Brand Name + Dosage Form + Strength Estramark 2gm/35mcg Tablet
Cyproterone Acetate…2mg
Ethinyloestradiol……35mcg"
Diary No. Date of R & I & fee Dy.No 10887 dated 05-03-2019 Rs.50,000 Dated 05-03-2019
Pharmacological Group Anti-androgen/estrogen
Type of Form Form-5
Approval status of product in Reference Co-cyprindiol 2000/35 microgram Film-coated Tablets of
Regulatory Authorities. MHRA approved
Me-too status Acne-Heal Tablet by M/s OBS (Reg# 073476)
 M/s Dyson Research Laboratories has approved Tablet
Hormone section
b. Deferred cases
1580. Name and address of manufacturer/ M/s StandPharm (Pvt.) limited, 20 Km Ferozepur Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength Citin 250mg injection
Citicoline Sodium eq. to Citicoline ………….250mg
Diary No. Date of R & I & fee Dy.No.17177; 05-10-2017; Rs.20,000/- (04-10-2017)
Pharmacological Group Psycho-stimulant and nootropic
Finished product Specification Not provided
Pack size & Demanded Price 1’s & 5’s (2ml) & Rs. 206/- ampoule
Me-too status Citicoline Injection 250mg of M/s Allied Pharmaceuticals
Karachi 021957
GMP status Last GMP inspection was conducted on 19-10-2017 and
the report concludes a satisfactory level of GMP
compliance.
Previous Remarks of the Evaluator The official monograph of the applied formulation
is not available in USP and BP.
The evidence of the applied formulation in the
reference regulatory authorities could not be
confirmed.
Previous decision Deferred in 285th DRB meeting 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-XIII Firm has submitted reference of ANSM; France, which is verified.
Applicant Lahore
Brand Name + Dosage Form + Strength Citin 500mg injection
Citicoline Sodium eq. to Citicoline ………….500mg
Pack size & Demanded Price 1’s & Rs. 310/ ampoule
Me-too status Citicoline Injection 500mg of M/s Allied Pharmaceuticals
Karachi 021958
compliance.
confirmed.
Evaluation by PEC-XIII Firm has submitted reference of ANSM; France, which is verified.
Applicant Lahore
Brand Name + Dosage Form + Strength Citin 1g injection
Citicoline Sodium eq. to Citicoline ………………1g
Pack size & Demanded Price 1’s & Rs. 400/ ampoule
Me-too status Neurolin Injection 1g of M/s Global Pharmaceuticals, Islamabad
026632
compliance.
confirmed.
Evaluation by PEC-XIII Firm has submitted reference of Citicolina 1000mg/ 4ml
injectable solution of M/s Sandoz SPA (Spain) which has been
verified.
1583. Name and address of manufacturer/ M/s Pharmix Laboratories Pvt Ltd, 21 Km, Ferozepur Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength Vita-3 250mg
Nicotinic Acid (Niacin)………………………….250mg
Pharmacological Group Peripheral vasodilator/ Anti- hypertensive
Me-too status Nicosur 250mg Tab of Zafa Karachi 011956
GMP status Last GMP inspection was conducted on 13-09-2019 and the report
concludes renewal of DML.
Previous Remarks of the Evaluator Reference could not be confirmed
BP

formulation in reference regulatory
Evaluation by PEC-XIII Firm has submitted TGA; Australia reference as Nicotinic acid
uncoated tablet 250mg which has been verified.
Applicant
Brand Name + Dosage Form + Strength Vita 3 500mg
Nicotinic Acid……………………………………500mg
Pharmacological Group Peripheral vasodilator/ Anti- hypertensive
Me-too status Nicosur 500mg Tab of M/s Zafa Karachi 011957
Previous Remarks of the Evaluator Reference could not be confirmed
BP
formulation in reference regulatory
Evaluation by PEC-XIII Firm has submitted USFDA reference as Niacor uncoated tablet
500mg which has been verified.
Applicant
Brand Name + Dosage Form + Strength Bivodil 10mg Tablet
Nebivolol as HCl…………...10mg
Pharmacological Group Beta blocking agent
Approval status of product in Reference MHRA Approved as uncoated tablet
Me-too status Nebivol Tablet of Tabros Pharma (Pvt) Ltd, Karachi 061532
Previous Remarks of the Evaluator MHRA Approved as uncoated tablet
Non pharmacopoeial.
Previous decision Deferred in 295th DRB meeting for revision of formulation as per
the reference product along with submission of requisite fee.
Evaluation by PEC-XIII Firm has submitted coating reference of USFDA which could not
be verified.
1586. Name and address of manufacturer/ M/s Barrett Hodgson Pakistan Pvt Ltd, F/423, SITE,
Applicant Karachi
Brand Name + Dosage Form + Strength Flusten Powder for Oral Suspension 40mg/ml
Fluconazole………………………………200mg
Diary No. Date of R & I & fee Dy.No.35733; 29-10-2018; Rs.50,000 (29-10-2018)
Pack size & Demanded Price Rs. 3750/- for 35ml & as per DRAPs policy
Me-too status Could not be confirmed in the applied strength (50mg/ 5ml is
available)
Previous Remarks of the Evaluator General Dry powder suspension section is available
in the firm as mentioned in the submitted section
approval letter.
Me- too status could not be verified in the applied
strength.
Previous decision Deferred in 293rd DRB meeting 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-XIII Firm has submitted whole Form-5 again but has not submitted me-
too status for which the drug was previously deferred.
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.
1587. Name and address of manufacturer/ M/s Himedic Pharmaceutical (Pvt.) Limited, 19-km Link Multan
Brand Name + Dosage Form + Strength Cefotam Injection 250mg
Cefotaxime Sodium eq. to Cefotaxime……...250mg
Diary No. Date of R & I & fee Dy. No. 7688; 06-07-2017; Rs.20,000/-(06-07-2017)
Pharmacological Group Third- generation Cephalosporin
Pack size & Demanded Price 250mg/vial (10ml) & Rs. 110/- or as per SRO
Me-too status Baxim Injection 250mg of M/s Nabi Qasim (Reg. # 027201)
report concludes satisfactory compliance with following remarks:
“Firm was advised to submit an action plan for
rectifications for further improvement of GMP compliance of the
firm.”
Previous Remarks of the Evaluator  5% overage is applied.
 The official monograph of the applied formulation is
available in USP.
 Firm was issued letter on 29-05-2018 and reminder on 17-
08-2018 but the firm has replied on 12-09-2018 which is
incorrect.
Previous decision Deferred in 285th DRB meeting for following reasons:
Updated status of GMP of the firm form QA & LT division as
inspection report submitted by firm does not conclude GMP
compliant status.
Justification of the applied 5% overage.
Evaluation by PEC-XIII Copy of GMP certificate has been submitted based on the
evaluation conducted on 24-01-2020.
For Justification of the applied 5% overage, firm has replied:
For these product USP specifications, 90- 110% are the assay
limits. We are adding 5% just to make it sure that patients get 100%
activity of the product even at the time of expiry.
In case, if DRAP policy does not allow us to add
overages, then we will not include it in the formulation of our drug.
Brand Name + Dosage Form + Strength Cefotam Injection 500mg
Cefotaxime Sodium eq. to Cefotaxime……...500mg
Pack size & Demanded Price 500mg/vial (10ml) & Rs. 110/- or as per SRO
Me-too status Baxim of M/s Nabi Qasim (Reg. # 027202)
firm.”
Previous Remarks of the Evaluator The official monograph of the applied formulation is available in
USP.
5% overage is applied.
Firm was issued letter on 29-05-2018 and reminder on 17-08-2018
but the firm has replied on 12-09-2018 which is incorrect.
compliant status.
For these product USP specifications, 90- 110% are
the assay limits. We are adding 5% just to make it sure that patients
get 100% activity of the product even at the time of expiry.
Brand Name + Dosage Form + Strength Cefotam Injection 1g
Cefotaxime Sodium eq. to Cefotaxime…………..1g
Pharmacological Group Third- generation Cephalosporins
Pack size & Demanded Price 1g/vial (10ml) & Rs. 276/- or as per SRO
Me-too status Baxim Injection 1g of M/s Nabi Qasim (Reg. # 027203)

firm.”
Previous Remarks of the Evaluator The official monograph of the applied formulation is available
in USP.
Firm was issued letter on 29-05-2018 and reminder on 17-08-
2018 but the firm has replied on 12-09-2018 which is incorrect.
compliant status.
Brand Name + Dosage Form + Strength Hidin injection 250mg
Cephradine with L- Arginine eq. to Cephradine..250mg
Pack size & Demanded Price 1x 1 vial & Rs. 44/- or as per SRO
Approval status of product in Reference Discontinued in USFDA
Me-too status Velosef injection 250mg of M/s Squibb (Reg. # 001870)
firm.”
Previous Remarks of the Evaluator International availability of the applied formulation could not
be confirmed.
The official monograph of the applied formulation is available
in BP.
compliant status.

Firm could not submit RRA reference of the applied drug.
I/M or I/V?
Applied volume?
Decision: Deferred for approval status in Reference Regulatory Authorities.
Brand Name + Dosage Form + Strength Hidin injection 500mg
Cephradine with L- Arginine eq. to Cephradine
……….……………………………..…..500mg
Pack size & Demanded Price 500mg x 1’s vial & Rs. 58/- or as per SRO
Me-too status Velosef injection 500mg of M/s Squibb (Reg. # 001866)
firm.”
be confirmed.
in BP.
Previous decision Deferred in 285th meeting for following reasons:
compliant status.
Firm has submitted reference of ANSM; France where both I/M
and I/V are registered.
I/M or I/V?
Applied volume?
th
Brand Name + Dosage Form + Strength Hidin injection 1g
Cephradine with L- Arginine eq. to Cephradine....1g
Pack size & Demanded Price 1g x 1’s vial & Rs. 107/- or as per SRO
Me-too status Velosef injection 1g of M/s Squibb (Reg. # 001869)
firm.”
be confirmed.
in BP.
Previous decision Deferred in 285th meeting for following reasons:
compliant status.
Firm has submitted reference of ANSM; France where both
I/M and I/V are registered.
I/M or I/V?
Applied volume?
1593. Name and address of manufacturer/ M/s Genesis Pharmaceuticals, Plot # 25, Sunder Industrial Estate,
Applicant Lahore.
Brand Name + Dosage Form + Strength Irosak tablet 150mg
Elemental iron as iron polymaltose complex…150mg
Type of Form Form-5
Pack size & Demanded Price 2x 10’s & s per SRO

Approval status of product in Reference Not applicable
Me-too status Could not be confirmed in the applied formulation as 100mg is
available
report concludes:
“A detailed re-inspection would be conducted in operational
mode. At the time of inspection unit was found non-operational.”
Previous Remarks of the Evaluator The evidence of applied strength of me-too status could not be
verified.
GMP status could not be confirmed by the report.
Previous decision Deferred in 290th DRB meeting for evidence of applied
formulation/ drug already approved by DRAP (generic
/me-too status) along with registration number, brand
Further, Registration Board referred the case to QA & LT
Division to update GMP status of Firm
on priority.
Evaluation by PEC- XIII Firm has submitted wrong me- too status as Ferricure Capsule
of M/s S.J. & G Fazul Ellahie, Karachi 050637 while tablets
are applied.
Firm has submitted its latest GMP inspection report which was
conducted on 03-02-2020 and the report concludes satisfactory
level of GMP compliance.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP (generic / me-
1594. Name and address of manufacturer/ M/s Next Pharmaceutical Products Private Limited, Plot No. 44
Applicant A-B, Sundar Industrial Estate, Lahore.
Brand Name + Dosage Form + Strength Paranext C 500/65mg Tablet
Paracetamol………………..500mg
Caffeine……………………..65mg
Pharmacological Group Analgesic/ CNS Stimulant
Pack size & Demanded Price 20’s, 100, 200 & as per SRO
Me-too status Cafimol Extra Tablets of Zinta Pharmaceutical Industry, 168-
Industrial Estate, Hyatabad, Peshawar 038898
GMP status 22-02-2018 satisfactory
Previous Remarks of the Evaluator Applied master formulation and manufacturing outline is not
Previous decision Deferred in 295th DRB meeting for the submission of master
formulation and manufacturing outline of the drug.
Evaluation by PEC- XIII Now the firm has submitted the master formulation and
manufacturing outline of the applied drug.
Decision: Approved.
1595. Name and address of manufacturer/ M/s Next Pharmaceutical Products Private Limited, Plot No. 44
Brand Name + Dosage Form + Strength Trimax 10/160/25mg Tablet
Amlodipine as besilate……..10mg
Valsartan……………….…160mg
Hydrochlorothiazide………..25mg

Pharmacological Group Angiotensin- II Receptor Blocker and Diuretic
Me-too status Exforge- HCT 10/160/25mg film- coated tablets of M/s Novartis
Pharma (Reg. # 069551)
Previous Remarks of the Evaluator On Form- 5 applied composition is in the strength of 20/ 160/ 25
while on fee- challan and master formulation the applied strength
is 10/160/25mg.
Diary number is same as that of 5/160/12.5 strength.
The official monograph for the applied formulation is available in
USP.
Previous decision Deferred in 295th DRB meeting for the justification that on Form-
5, applied composition is in the strength of 20/ 160/ 25 while on
fee- challan and master formulation the applied strength is
10/160/25mg.
Evaluation by PEC- XIII Firm has replied that due to typographic mistake, the strength of
Amlodipine Besylate was written as 20mg instead of 10mg in the
composition mentioned on Form- 5. Now, the firm has submitted
rectified composition in Form- 5.
1596. Name and address of manufacturer/ M/s Next Pharmaceutical Products Private Limited.
Applicant Plot No. 44 A-B, Sundar Industrial Estate, Lahore
Brand Name + Dosage Form + Strength Trimax 5/160/12.5mg Tablet
Amodipine as besilate……..…5mg
Valsartan…………………..160mg
Hydrochlorothiazide………12.5mg
Me-too status Exforge- HCT 5/160/12.5mg film- coated tablets of M/s Novartis
Pharma(Reg. # 069548)
Previous Remarks of the Evaluator Diary Number Is Same As That Of 10/160/25 Strength.
On Form- 5 applied composition is in the strength of 20/ 160/ 12.5
while on fee-challan and master formulation the applied strength is
5/160/12.5mg.
USP.
5, applied composition is in the strength of 20/ 160/ 12.5 while on
5/160/12.5mg.

1597. Name and address of manufacturer/ M/s Next Pharmaceutical Products Private Limited.Plot No. 44
Applicant A-B, Sundar Industrial Estate, Lahore
Amlodipine as besilate………5mg
Valsartan………………….160mg
Hydrochlorothiazide………..25mg
Me-too status Exforge- HCT 5/160/25mg film- coated tablets of M/s Novartis
Pharma (Reg. # 069549)
Previous Remarks of the Evaluator The official monograph for the applied formulation is available in
USP.
On Form- 5 applied composition is in the strength of 20/ 160/ 25
is 5/160/25mg.
5/160/25mg.
Amlodipine as besilate…..10mg
Valsartan……………..…320mg
Hydrochlorothiazide…...…25mg
Me-too status Exforge HCT 10/320/25mg of M/s Novartis Pharma 069552
Previous Remarks of the Evaluator The official monograph for the applied formulation is available in
USP.
On Form- 5 applied composition is in the strength of 20/ 320/ 25
is 10/320/25mg.
10/320/25mg.

1599. Name and address of manufacturer/ M/s Genesis Pharmaceuticals, Plot # 25, Sunder Industrial Estate,
Applicant Lahore.
Brand Name + Dosage Form + Strength Tragenol tablet 37.5mg/ 325mg
Tramadol HCl…………………37.5mg
Paracetamol ……………………325mg
Pharmacological Group Analgesic / Anti-pyretic
Ultracet tablets of Janssen Pharmaceuticals (USFDA Approved)
Me-too status Tonoflex P of M/s Sami Pharma (Reg. # 067163)
GMP status GMP report submitted does not possess any date and the report
concludes :
“A detailed re-inspection would be conducted in
operational mode in order to assess GMP compliance as at the
moment unit was completely found non- operational.”
Previous Remarks of the Evaluator GMP report has no date and is not conclusive.
Firm has general tablet section.
Previous decision Deferred in 285th DRB meeting for updated status of GMP of the
firm form QA & LT division as the inspection report submitted by
firm does not conclude GMP compliant status.
Evaluation by PEC- XIII Firm has submitted its latest inspection report dated 03-02-2020
concluding satisfactory level of GMP compliance of the firm.
Decision: Approved.
1600. Name and address of manufacturer/ M/s Swiss Pharmaceuticals (Pvt) Ltd. Plot No. A-159, S.I.T.E.,
Brand Name + Dosage Form + Strength Vomloc Tablet 10mg/ 10mg

Doxylamine Succinate...…10mg
Pyridoxine HCl…………....10mg
Diary No. Date of R & I & fee Dy. No.7737; 01-03-2018; Rs. 20,000 (28-02-2018)
Type of Form Form-5
Approval status of product in Reference Xonvea 10 mg/10 mg gastro-resistant tablets of M/s Alliance
Regulatory Authorities. Pharma (MHRA Approved)
Me-too status Xyquil DR Tablet (Delayed- Release) of M/s Sami
(R.#076469)
GMP status Last GMP inspection was conducted on18-10-2018 and the report
concludes good GMP compliance.
Previous Remarks of the Evaluator  Firm has General tablet section as mentioned in the
submitted inspection report.
 Firm has claimed USP specifications while the
official monograph for the applied formulation is not
available in USP or BP.

 The applied formulation is approved in MHRA as
gastro resistant & film-coated tablet while it is
applied as film coated only.
 Me- too status is also of Delayed-release tablet.
Previous decision Deferred in 290th DRB meeting for following:
Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) along with registration
Evaluation by PEC- XIII Firm has revised its label claim and master formulation
according to the reference but has not submitted fees for
revision of formulation i.e. Rs. 5000/-.
Previous Decision:
Deferred in 293rd DRB meeting for submission of requisite fees for revision of formulation according to
the reference.
Second evaluation by PEC- XIII: Firm has submitted Rs. 5000/- for revision of formulation.
Decision: Deferred for submission of
1601. Name and address of manufacturer/ M/s Safe Pharmaceuticals Pvt. Ltd, Plot No. C.I-20,
Applicant Sector 6-B, Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Tazox 250mg /Vial Injection (I.V)
Composition Each Vial of Dry Substance Contains:
Ceftriaxone Sodium Eq. to Ceftriaxone ………... 250mg
Pack size & Demanded Price 1’s & As Per SRO
Me-too status Aventriax 250mg Injection of M/s. Sanofi Aventis
(Pakistan) Ltd 050376
GMP status Last GMP Inspection was conducted on 04-03-2019 and the
report concludes that the firm was working under good level of
GMP compliance.
Previous Remarks of the Evaluator Cephalosporin Dry Powder Injection Section is
available in the firm as mentioned in the submitted GMP inspection
report
Previous decision Deferred in 293rd DRB meeting for the confirmation of already
registered drugs in the name of applicant.
Evaluation by PEC- XIII Firm has replied:
Following injection was registered of the same product but it was
an I/M injection
Fitobid 250mg injection I/M (Reg.# 048879)
Now we have applied I/V injection of same formulation.
Decision: Approved.
Brand Name + Dosage Form + Strength Tazox 500mg / Vial Injection (I.V.)
Ceftriaxone Sodium Eq. to Ceftriaxone .…… 500mg
Me-too status Aventriax 500mg Injection of M/s. Sanofi Aventis
GMP compliance.
available in the firm as mentioned in the submitted
an I/M injection
Fitobid 500mg injection I/M (Reg.# 048880)
Decision: Approved.
Brand Name + Dosage Form + Strength Tazox 1g / Vial Injection (I.V.)
Ceftriaxone Sodium Eq. to Ceftriaxone .………….… 1g
Me-too status Aventriax 1g Injection of M/s. Sanofi Aventis
GMP compliance.
an I/M injection
Fitobid 1g injection I/M (Reg.# 048881)
Decision: Approved.
Brand Name + Dosage Form + Strength Tazox 2g / Vial Injection (I.V.)
Ceftriaxone Sodium Eq. to Ceftriaxone .………….… 2g

Me-too status Triax 2g Injection of M/s Wilshire Laboratories
(Reg. # 071571)
GMP compliance
We have applied I/V injection of same formulation being
registered to us already but they were of different strengths
(250mg, 500mg & 1g) and were I/M.
Decision: Approved.
Applicant Sector 6- B, Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Mentazil tablet 10mg
Memantine HCl ………………………...………... 10mg
Diary No. Date of R & I & fee Dy.No.39136 dated 28-11-2018 Rs.20,000/- Dated 27-11-
2018
Pharmacological Group Anti- Dementia Drug
Pack size & Demanded Price 2 x 10’s & As Per SRO
Me-too status Contine 10mg Tablet of M/s Lexicon (Reg. # 055962)
GMP compliance.
Previous Remarks of the Evaluator  General tablet section is available in the firm as
mentioned in the submitted GMP report.
 Initially, uncoated was applied while is approved in
MHRA as film- coated.
 Firm has revised applied formulation as film- coated
and has submitted requisite fees for revision of
0formulation (Rs. 5000/-).
Evaluation by PEC- XIII Firm has replied that this drug has been applied for the first time.
Decision: Approved.
1606. Name and address of manufacturer/ M/s Espoir Pharmaceutical, Laboratory Complex, University
Applicant Road, Karachi
Brand Name + Dosage Form + Strength Vidogip tablets 50mg

Vildagliptin ……………....50mg
Diary No. Date of R & I & fee Dy.No.7182;26-02-2018; Rs.20,000/- (23-02-2018)
Finished product Specification Not claimed
Pack size & Demanded Price 2x 14’s & As per DRAP policy

Approval status of product in Reference Galvus (Vildagliptin 50 mg tablets un-coated) by
Regulatory Authorities. Novartis Pharmaceuticals Australia Pty Ltd. TGA
Approved
Me-too status V- Glip 50mg uncoated tablet of M/s Wellborne Pharma
(Reg. # 080908)
report concludes good GMP compliance with assurance of earlier
compliance against the observations being observed during
inspection.
Previous Remarks of the Evaluator Firm has General Tablet section as mentioned in the submitted
Firm has applied as film- coated tablet while the
formulation is approved in reference regulatory
authority as uncoated tablet.
No USP or BP monograph is available for the
Previous decision Deferred in 288th DRB for the clarification of manufacturing
outline as in reference regulatory authorities the approved drug is
uncoated tablet, while the applied drug is film coated tablet.
Evaluation by PEC- XIII Firm has revised the manufacturing outline according to
reference but needs to submit the requisite fees for revision of
formulation.
Decision: Deferred for submission of requisite fees for revision of formulation.
Applicant Road, Karachi.
Brand Name + Dosage Form + Strength Maxicam tablet 7.5mg
Meloxicam ………………7.5mg
Pack size & Demanded Price 10’s & as per brand leader
Me-too status Artex un-coated tablet of M/s Pharmedic (Reg. # 023939)
concludes good GMP compliance with assurance of earlier
inspection.
The applied formulation is approved as uncoated in USFDA and
dispersible in MHRA while the firm has applied the formulation as
film-coated tablet.
No USP or BP monograph is available for the applied
formulation.
Previous decision Deferred in 288th DRB for revision of formulation as per reference
product along with submission of requisite fee for change of
formulation.
formulation.
Applicant Road, Karachi.
Brand Name + Dosage Form + Strength Maxicam tablet 15mg

Meloxicam ……………….15mg
Pack size & Demanded Price 10’s & as per DRAP policy
Me-too status Artex un-coated tablet of M/s Pharmedic (Reg. # 023940)
concludes good GMP compliance with assurance of earlier
inspection.
The applied formulation is approved as uncoated in USFDA and
dispersible in MHRA while the firm has applied the formulation as
film-coated tablet.
No USP or BP monograph is available for the applied formulation.
Previous decision Deferred in 288th DRB meeting for revision of formulation as
per reference product along with submission of requisite fee
for change of formulation.
formulation.
1609. Name and address of manufacturer/ M/s Bloom Pharmaceuticals Pvt. Ltd, Plot # 30, Phase I & II,
Applicant Industrial Estate, Hattar, Pakistan.
Brand Name + Dosage Form + Strength Bluphen tablet 10mg
Methylphenidate Hydrochloride…………..10mg
Diary No. Date of R & I & fee Dy.No.39133;28-11-2018;Rs.20,000(28-11-2018)
Pharmacological Group CNS Stimulant
Me-too status Hynidate tablet 10mg of M/s Safe Pharma (Reg. # 053053)
concludes satisfactory level of cGMP with grant of GMP
certificate.
GMP report of the firm.
Previous decision Deferred in 293rd DRB meeting for confirmation of
manufacturing facility of Psychotropic drugs.
Evaluation by PEC- XIII Firm has submitted copy of DML and GMP certificate showing
psychotropic tablet section.
Decision: Approved.
1610. Name and address of manufacturer/ M/s Albro Pharma Private Limited, 340- S Industrial state, Kot
Applicant Lakhpat, Lahore, Pakistan
Brand Name + Dosage Form + Strength Accred tablet 100mg
Diclofenac Sodium………………………....100mg
Approval status of product in Reference Could not be confirmed as film- coated (enteric- coated is available
Regulatory Authorities in USFDA)
Me-too status Sintral SR tablet 100mg of M/s Neomedix Pharma
(Reg. # 081413)
concludes:
“Based on the area inspected, people met, the documents reviewed
and considering the findings of the inspection, the firm M/s Albro
Pharma is complying most of the GMP guidelines under Drugs
Act, 1976 and DRAP Act, 2012. However, the deficiencies pointed
out were discussed with the management and the firm has agreed
to submit corrective actions taken with in stipulated time period.
Moreover, as per last inspection report it was maintained that the
Licensing Board in its 245th Meeting held on 22-02-2016, directed
the firm to purchase land of at least 4 kanals in 6 months and
complete facility within a period of two years. In compliance the
firm has purchased a land of 12 Kanals and 18 Marlas in District
Kasur, which was approved vide DRAP, Islamabad letter No
F.14/2018-Lic dated 06-03-2019. However, the firm may be asked
to provide the status of new facility, so that the unit could be shifted
with in stipulated time period.”
Previous Remarks of the Evaluator In USFDA, it is enteric- coated while in the applied master
formulation it is applied as film- coated.
Previous decision Deferred in 293rd DRB meeting for revision of formulation as
per reference product along with submission of requisite fee.
Evaluation by PEC- XIII Firm has submitted revision of formulation as per reference
product along with submission of requisite fee i.e. Rs. 5000/-.
Decision: Deferred for submission of remaining fees of revision of formulation i.e. Rs. 15000/-.
1611. Name and address of manufacturer/ M/s Pharmasol (Pvt.) Ltd, Plot No. 549, Sundar Industrial Estate,
Brand Name + Dosage Form + Strength Cinatasol tablet 1mg
Cinitapride as hydrogen tartrate …..…….….…1mg
Approval status of product in Reference Approved in Spain as uncoated tablet
Me-too status Cinita tablets 1mg of M/s Novamed Pharma
(Reg. # 064845)
GMP status Last GMP inspection was conducted on 03-4-10-2017 and the
report concludes grant of Drug Manufacturing License for 27
Sections.
Previous Remarks of the Evaluator The applied formulation is non- pharmacopoeial.
Applied as film- coated tablet while approved in Spain as uncoated
tablet.
Previous decision Deferred in 293rd DRB meeting as the formulation is applied as
film-coated tablet while it is approved in
reference regulatory authority (Spain) as uncoated tablet.
Evaluation by PEC- XIII Firm has submitted revision of formulation as per reference
product along with submission of requisite fee i.e. Rs. 5000/-.

1612. Name and address of manufacturer/ M/s Standpharm Pakistan (Pvt) Limited, 20-Km Ferozepur Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength Acrol capsule 0.5mg
Tacrolimus as Monohydrate ………………….0.5mg
Diary No. Date of R & I & fee Dy. No.30469; 10-09-2018; Rs.20,000/- (04-09-2018)
Pack size & Demanded Price 3x 10’s & Rs.27.45/- per capsule
Approval status of product in Reference Adoport 0.5mg hard capsules of M/s Sandoz Limited (MHRA
Me-too status Inograf 0.5mg capsule of M/s Platinum Pharma
(Reg. # 045490)
report concludes satisfactory GMP compliance.
Previous Remarks of the Evaluator  The firm has General capsule section as mentioned in
the GMP report.
 According to GMP inspection report, firm was advised
to enhance the efficiency of temperature, pressure and
relative humidity control system in the General
capsule section.
Previous decision Deferred in 290th DRB meeting for updated GMP inspection
report as firm was advised to enhance the
efficiency of temperature, pressure and relative humidity
control system in the General capsule
section.
Evaluation by PEC- XIII  Firm has now submitted its latest GMP inspection
report dated 18-02-2020 and the report concludes
renewal of DML.
mentioned in the submitted copy of DML.
Decision: Approved.
Applicant Lahore.
Brand Name + Dosage Form + Strength Acrol capsule 1mg
Tacrolimus as Monohydrate ………………....1mg
Pharmacological Group Immuno-suppressant
Pack size & Demanded Price 3x 10’s & Rs. 46/- per capsule
Approval status of product in Reference Adoport 1mg hard capsules of M/s Sandoz Limited (MHRA
Me-too status Inograf 1mg capsule of M/s Platinum Pharma
(Reg. # 045491)
Previous Remarks of the Evaluator The firm has General capsule section as mentioned in the GMP
report.
According to GMP inspection report, firm was advised to enhance
the efficiency of temperature, pressure and relative humidity
control system in the General capsule section.
section.
Evaluation by PEC- XIII Firm has now submitted its latest GMP inspection report dated 18-
02-2020 and the report concludes renewal of DML.
General capsule section is available in the firm as mentioned in the
submitted copy of DML.
Applicant Lahore.
Brand Name + Dosage Form + Strength Acrol capsule 5mg
Tacrolimus as Monohydrate …………........5mg
Pack size & Demanded Price 10’s & Rs. 247.059/- per capsule
Approval status of product in Reference Adoport 5mg hard capsules of M/s Sandoz Limited (MHRA
Me-too status Inograf 5mg capsule of M/s Platinum Pharma
(Reg. # 045492)
Previous Remarks of the Evaluator The firm has General capsule section as mentioned in the GMP
report.
According to GMP inspection report, firm was advised to
enhance the efficiency of temperature, pressure and relative
humidity control system in the General capsule section.
section.
Evaluation by PEC- XIII Firm has now submitted its latest GMP inspection report dated
18-02-2020 and the report concludes renewal of DML.
General capsule section is available in the firm as mentioned
in the submitted copy of DML.
1615. Name and address of manufacturer/ M/s Wimits Pharmaceuticals (Pvt.) Ltd, Plot No. 129, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore
Brand Name + Dosage Form + Strength Telmisin-A 5/40 mg tablet
Amlodipine as Besylate……………………….5mg
Telmisartan…………………………………..40mg
Diary No. Date of R & I & fee Dy.No 29718; 05-09-2018;Rs.20,000 (05-09-2018)
Pharmacological Group Angiotensin- II Receptor Antagonist /Calcium Channel Blocker
Approval status of product in Reference USFDA Approved as bilayered
Me-too status Amtas 5mg + 40mg Tablet of M/s Getz Pharma

(Reg.# 066943)
concludes satisfactory GMP compliance.
Previous Remarks of the Evaluator General tablet section is available in the firm as mentioned in
Manufacturing facility needs to be confirmed.
in USP.
Previous decision Deferred in 293rd DRB meeting for the following:
Evidence of purchase of required manufacturing equipment
i.e. tablet bilayered machine as reference product is a bi-
layer tablet.
Evaluation by PEC- XIII  Firm has submitted purchase slip of ZP-33 Rotary Tablet
Press Machine (Bi- layered) from Munawar Bhatti
Engineering Works, Lahore at Rs. 35,32,500/-.
 But firm has not revised the master formulation as bi-
layered tablet and requisite fees needs to be submitted for
 Revision of formulation as per reference product i.e bilayered tablet.
 Submission of requisite fees for revision of formulation.
 Submission of IQ, OQ and PQ documents.
Brand Name + Dosage Form + Strength Telmisin- A 5/80 mg tablet
Amlodipine as Besylate……………………….5mg
Me-too status Amtas 5mg + 80mg Tablet of M/s Getz Pharma
(Reg.# 066944)
 Manufacturing facility needs to be confirmed.
available in USP.
 On Form- 5, another strength 40mg & 10mg is
mentioned.
Previous decision  Deferred in 293rd DRB meeting for the following:
Evidence of purchase of required manufacturing
equipment i.e. tablet bilayered machine
as reference product is a bilayer tablet.
mentioned while applied strength is 5mg/
80 mg.
Evaluation by PEC- XIII  Firm has corrected the applied strength as 5mg/
80 mg on Form- 5.

 Firm has submitted purchase slip of ZP-33 Rotary Tablet
 Submission of IQ, OQ and PQ documents..
Amlodipine as Besylate……………………...10mg
Diary No. Date of R & I & fee Dy.No 29720; 05-09-2018;Rs.20,000 (05-09-2018)
Me-too status Amtas 10mg + 40mg tablet of M/s Getz Pharma
(Reg.# 066945)
Previous Remarks of the Evaluator General tablet section is available in the firm as mentioned in the
submitted section approval letter.
USP.
On Form- 5, another strength 40mg & 5mg is mentioned.
Evidence of purchase of required manufacturing equipment
i.e. tablet bilayered machine as reference product is a bilayer
tablet.
On Form- 5, another strength 40mg & 5mg is mentioned
while applied strength is 10mg/ 40 mg.
 Firm has corrected the applied strength as 10mg/
40 mg on Form- 5.
Applicant Industrial Estate, Raiwind Road, Lahore.
Amlodipine as Besylate……………………...10mg
Diary No. Date of R & I & fee Dy.No.29721 ; 05-09-2018;Rs.20,000 (05-09-2018)
Me-too status Amtas 10mg + 80mg tablet of M/s Getz Pharma
(Reg.# 067472)
 Revise label claim as bi-layered.
available in USP.
mentioned.
 Evidence of purchase of required manufacturing
equipment i.e. tablet bilayered machine as reference
product is a bilayer tablet.
mentioned while applied strength is 10mg/ 80 mg.
 Firm has corrected the applied strength as 10mg/
80 mg on Form- 5.
Brand Name + Dosage Form + Strength Telmisin- D 40/12.5 mg Tablet
Hydrochlorothiazide……………………….12.5mg
Me-too status Telsarta- D 40/12.5 tablet of M/s Pharm Evo (Reg. # 061915)
Previous Remarks of the Evaluator General tablet section is available in the firm as mentioned in

in USP.
Revise label claim as bi-layered.
Previous decision Deferred in 293rd DRB meeting for evidence of purchase of
required manufacturing equipment i.e. tablet bilayered
machine as reference product is a bilayer tablet.
Evaluation by PEC- XIII Firm has submitted purchase slip of ZP-33 Rotary Tablet Press
Machine (Bi- layered) from Munawar Bhatti Engineering Works,
Lahore at Rs. 35,32,500/-.
But firm has not revised the master formulation as bilayered tablet
and requisite fees needs to be submitted for revision of
formulation.
Brand Name + Dosage Form + Strength Telmisin- D 80/12.5 mg Tablet
Hydrochlorothiazide……………………….12.5mg
Me-too status Telsarta- D 80/12.5 tablet of M/s Pharm Evo (Reg. # 061914)
available in USP.
 Revise label claim as bi-layered.
Previous decision Deferred in 293rd DRB meeting for evidence of purchase of
required manufacturing equipment i.e. tablet bilayered
machine as reference product is a bilayer tablet
Brand Name + Dosage Form + Strength Leveon Plus Tablet
Levodopa……………………………………150mg
Carbidopa…………………………………37.50mg
Entacapone………………………………….200mg
Pharmacological Group Anti-parkinson dopaminergic agent
Me-too status Obsonerv 37.5/150/200mg tablet of M/s OBS Pakistan (Reg. #
070443)
Previous Remarks of the Evaluator  Salt is not complete because Carbidopa as
monohydrate will come.
 No official monograph is available for the applied
formulation.
 Methylene Chloride is added in the coating solution of
the formulation.
Previous decision Deferred in 293rd DRB meeting for the following reasons:
Applied composition is not complete because Carbidopa
“as Monohydrate” is approved in reference regulatory
authority.
Applying a banned excipient “Methylene Chloride” in the
coating solution of the applied formulation.
Evaluation by PEC- XIII  Firm has revised its Form- 5 and master formulation as
“Carbidopa as Monohydrate”.
 Firm has excluded methylene chloride in the applied
formulation.
Brand Name + Dosage Form + Strength Levocard tablet
Levodopa…………………………100mg
Carbidopa………….…...………….25mg
Entacapone……………………….200mg
Me-too status Obsonerv 25/100/200mg tablet of M/s OBS Pakistan (Reg. #
070444)
Previous Remarks of the Evaluator Salt is not complete because Carbidopa as monohydrate will
come.
No official monograph is available for the applied formulation.
Methylene Chloride is added in the coating solution of the
formulation.
General tablet section is available in the firm as mentioned in
Applied composition is not complete because Carbidopa “as
Monohydrate” is approved
in reference regulatory authority.
coating solution of the applied
formulation.
 Firm has again mentioned methylene chloride in the
Decision: Deferred for clarification for using Methylene Chloride which is a banned excipient.
Brand Name + Dosage Form + Strength Levocard tablet
Levodopa………………..200mg
Carbidopa……………..….50mg
Entacapone……………….200mg
Me-too status Obsonerv 50/200/200mg tablet of M/s OBS Pakistan (Reg. #
070441)
Previous Remarks of the Evaluator  Salt is not complete because Carbidopa as
monohydrate will come.
 No official monograph is available for the applied
formulation.
 Methylene Chloride is added in the coating solution of
the formulation.
Applied composition is not complete because Carbidopa
“as Monohydrate” is approved in reference regulatory
authority.
coating solution of the applied formulation.
 Firm has excluded methylene chloride in the applied
formulation.
1624. Name and address of manufacturer/ M/s Welwink Pharmaceuticals, Factory G.T. Road, Industrial
Applicant Estate, Gujranwala Cantt.
Brand Name + Dosage Form + Strength Dixitol capsule 30mg
Duloxetine HCl……………………………………..30mg
Me-too status Duloxwrd 30 mg capsules of M/s Welwrd Pharma
(Reg. # 076815)
GMP status Last GMP inspection was conducted on 20-12-2017 and the panel
concluded that the firm was operating at satisfactory level of GMP
compliance for all sections except liquid injectable section for
which the firm was advised to provide liquid particle counter and
TOC at the earliest.
Previous Remarks of the Evaluator  Source of pellets, CoA of manufacturer, stability data
of pellets and GMP certificate of source of pellets is
not submitted.
 “As” HCl is approved in reference.
available in USP.
 Letter was issued to the firm on 13th December, 2019
but still the firm has not replied yet.
Previous decision Deferred in 293rd DRB meeting for following reasons:-
Source of pellets along with stability studies data, CoA of
manufacturer, GMP certificate of supplier and differential fee
in case of import of pellets.
“Duloxetine HCl” is applied while Duloxetine “as” HCl is
approved in reference regulatory authorities.
Evaluation by PEC- XIII  Firm has submitted source of pellets as M/s Vision
Pharma, Islamabad and all the related documents have
been submitted by the firm regarding pellets.
 Moreover, firm has corrected the applied composition as
Duloxetine as HCl in Form- 5 and master formulation.
1625. Name and address of manufacturer/ M/s Wilshire Laboratories Pvt. Ltd, 124/1, Quaid -e-Azam
Applicant Industrial Estate, Kot Lakhpat, Lahore.
Brand Name + Dosage Form + Strength Lespra Capsule 30mg
Composition Each delayed release capsule contains:
Lansoprazole…………………...30mg
Pharmacological Group Drugs for peptic ulcer and GORD (PPIs)
Pack size & Demanded Price 5’s, 7’s, 10’s, 20’s, 30’s, 40’s, 50’s & As per SRO
Me-too status Lanzac 30mg Capsules Don Valley Pharmaceuticals Lahore
020293
concludes satisfactory level of GMP compliance.
Previous Remarks of the Evaluator All the data related to pellets is needed.
General capsule section is available in the firm as mentioned in the
USP.
Previous decision Deferred for source of pellets, along with stability studies data,
GMP certificate of supplier and differential fee in case of import
of pellets.

Evaluation by PEC- XIII Firm has submitted source of pellets as M/s Vision Pharma,
Islamabad and all the related documents have been submitted by
the firm regarding pellets.
Brand Name + Dosage Form + Strength Qosmet XR 100/1000 mg Tablet
Composition Each Film Coated Sustained Release Tablet Contains:
Sitagliptin as phosphate Monohydrate …100mg
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, 40’s & As per SRO
Me-too status Tagipmet XR 100/1000 Tablet Highnoon Laboratories Limited,
Multan Road, Lahore 084651
Previous Remarks of the Evaluator Stability data is required for the applied formulation.
General tablet section is available in the firm as mentioned in the
Previous decision Registration Board deferred the case for submission of stability
study data as per the guidelines provided in 278th meeting of
Registration Board along with submission of differential fees.
Evaluation by PEC- XIII Firm has to submit stability studies data.
Sitagliptin as phosphate Monohydrate ………..50mg
Metformin HCl……………………………….500mg

Sitagliptin………………………………………50mg
Metformin HCl…………………………...…1000mg
1629. Name and address of manufacturer/ M/s Hicon Pharmaceuticals, 131-Industrial Estate, Hayatabad.
Applicant
Brand Name + Dosage Form + Strength Itocon OD Tablets 150mg
Itopride HCl………………150mg
Me-too status Itop S.R 150mg Tablet Nexus Pharma, Karachi 070883
GMP status Last GMP isnepction was conducted on 26-07-2018 and the report
concludes that the firm is operating at good level of GMP
compliance. The panel unanimously recommends the grant of
renewal of DML by way of formulation of M/s Hicon Pharma
Peshawar for following sections:
i- Tablet Section (Gen)
ii- Tablet section (Gen Antibiotic)
iii- Liquid Syrup section (Gen)
Previous decision Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies which were adopted by
Evaluation by PEC- XIII Firm says:
It is to clarify that we applied for the aforesaid drug on 21st
February, 2019 after confirmation from the minutes of 288th

meeting of registration Board in which Itopride as HCl 150mg
tablets are approved to M/s Invictus Pharmaceuticals (Page 309 of
minutes of 288th DRB meeting attached).
But unfortunately, this decision was reversed and the case was
deferred in 291st DRB meeting held in September 2019.
Clearly, DRAP has committed a mistake in this case so it is our
humble request to allow us to submit another dossier against the
fee- challan used for Itocon OD tablets as we are not liable to lose
20,000 PKR for the mistake that is not even committed by us.
It is, therefore, requested to kindly forward our request to
concerned authority and oblige.
1630. Name and address of manufacturer/ M/s Wilson’s Pharmaceuticals, 387-388, I-9 Industrial Area,
Brand Name + Dosage Form + Strength Coldene day tablets

Acetaminophen………….500mg
Phenylephrine HCl….….......5mg
Diary No. Date of R & I & fee Dy. No. 16694, R&I Dated 02.10.2017, Rs. 20,000/-
(02.10.2017)
Pharmacological Group Analgesic, Non-opioid/ Sympathomimetic Decongestants
Pack size & Demanded Price 1x 10’s, 10x 10’s & as per SRO
GMP status GMP inspection conducted on 24-01-2018 with conclusive
remarks that firm was operating at very good level of GMP
Previous Remarks of the Evaluator The local and international availability of the
applied formulation could not be confirmed.
Previous decision Deferred in 284th DRB meeting as the the local and
international availability of the applied formulation
could not be confirmed.
Evaluation by PEC- XIII  International reference has been verified as Demazin Cold
+ Flu Relief tablet of iNova Pharmaceuticals (Australia)
Pty Ltd TGA; Australia Approved.
 Me- too submitted by the firm has been verified as:
Panadol CF Day Caplet (Paracetamol 500mg and Phenylephrine
HCl 5mg of M/s GSK, Karachi 094797.
 The applied formulation is on stability so firm needs to
submit stability studies data of atleast three batches at
accelerated and real time conditions.
1631. Name and address of manufacturer/ M/s Wilson’s Pharmaceuticals, 387-388, I-9 Industrial Area,
Brand Name + Dosage Form + Strength Balance-H tablets 80/12.5mg

Temisartan…………….…80mg
Hydrochlorothiazide…...12.5mg
Diary No. Date of R & I & fee Dy. No. 16696, R&I Dated 02.10.2017, Rs. 20,000/-
(02.10.2017)

Pharmacological Group Antihypertensive , Angiotensin-II receptor antagonist/
A thiazide diuretic
Pack size & Demanded Price 2x7’s, 4x7’s & as per SRO
Approval status of product in Reference Approved in MHRA as uncoated
Me-too status Co- telsan tablets of M/s Hilton Pharmaceuticals
(Reg. # 047125)
GMP status GMP inspection conducted on 24-01-2018 with conclusive
remarks that firm was operating at very good level of GMP
Previous Remarks of the Evaluator Approved in MHRA as uncoated while is applied
as film-coated.
Previous decision Deferred in 284th DRB meeting as the applied formulation is
approved in MHRA as uncoated while is applied as film-coated.
Evaluation by PEC- XIII  Firm has submitted international reference of Micardis
HCT USFDA Approved drug which is bilayered
uncoated tablet.
 Firm has revised the formulation as bilayered uncoated
tablet and has provided evidence of availability of bi-
layered tablet machine.
 Firm has revised the applied formulation according to the
reference with submission of Rs. 5000/- fees under deposit
slip # 2035247 dated: 31st August, 2020.
Decision: Approved.
Brand Name + Dosage Form + Strength Raninext 150mg Tablet
Ranitidine as Hydrochloride……………………150mg
Pharmacological Group Anti- allergic
Pack size & Demanded Price 10, 20, 30 & As per SRO
Approval status of product in Reference MHRA Approved as film- coated
Me-too status Ranitide 150mg Tab of M/s Siza Lahore 011747
Previous Remarks of the Evaluator On fee challan brand name is raninext but composition is
glimepiride and metformin
while in form- 5 and master formulation applied composition is
Ranitidine
MHRA Approved as film- coated while is applied as uncoated.
Previous decision Deferred in 295th DRB meeting for the following reasons:
 Justification that on fee- challan brand name is
Raninext but composition is of glimepiride and
metformin. While in Form- 5 and master formulation
applied composition is Ranitidine.
 Clarification of manufacturing outline as in reference
regulatory authorities the approved drug is film-coated
tablet, while the applied drug is uncoated tablet.
Evaluation by PEC- XIII  Firm has replied that:
o Due to typographic mistake, the composition o
fee- challan was written as Glimepiride and
Metformin.
o International reference is Zantac 150mg tablets of
GSK which are uncoated tablets (according to the
firm).
 Submitted reference of Zantac tablets of GSK are
discontinued in MHRA and are coated tablets as revealed
in the SMPC of the product.
 Moreover, Registration Board in its 294th meeting has
decided to suspend registration of all ranitidine
containing medicinal products, based upon the FDA
decision.
th
Decision: Registration Board in its 294 meeting has decided to suspend registration of all ranitidine
Brand Name + Dosage Form + Strength Raninext 300mg Tablet
Ranitidine as Hydrochloride………………………300mg
Pharmacological Group Anti- allergic
Pack size & Demanded Price 10, 20, 30 & As per SRO
Approval status of product in Reference MHRA Approved as film- coated
Me-too status Ranitide 150mg Tab of M/s Siza Lahore 011747
Previous Remarks of the Evaluator  On fee- challan brand name is raninext but
composition is of glimepiride and metformin.
 While in Form- 5 and master formulation applied
composition is Ranitidine.
 MHRA Approved as film- coated while is applied as
uncoated.
Previous decision Deferred in 295th DRB meeting for the following reasons:
 Justification that on fee- challan brand name is
Raninext but composition is of glimepiride and
metformin. While in Form- 5 and master
formulation applied composition is Ranitidine.
 Clarification of manufacturing outline as in
reference regulatory authorities the approved drug
is film-coated tablet, while the applied drug is
uncoated tablet.
Evaluation by PEC- XIII Firm has replied that:
 Due to typographic mistake, the composition o fee-
challan was written as Glimepiride and Metformin.
 International reference is Zantac 150mg tablets of
GSK which are uncoated tablets (according to the
firm).
 Submitted reference of Zantac tablets of GSK are
discontinued in MHRA and are coated tablets as
revealed in the SMPC of the product.
 Moreover, Registration Board in its 294th meeting
has decided to suspend registration of all
ranitidine containing medicinal products, based
upon the FDA decision.
th
Decision: Registration Board in its 294 meeting has decided to suspend registration of all ranitidine

1634. Name and address of manufacturer/ M/s Next Pharmaceutical Products Private Limited.
Applicant Plot No. 44 A-B, Sundar Industrial Estate, Lahore
Brand Name + Dosage Form + Strength Painext- K tablet 25mg
Diclofenac potassium…..…25mg
Type of Form Form-5
Me-too status Could not be confirmed in the applied strength as 50, 70 and
100mg are available
Previous Remarks of the Evaluator Me- too Could not be confirmed in the applied strength as 50, 70
and 100mg are available.
formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of
firm.
Evaluation by PEC- XIII Firm has submitted me- too as:
Signa 25mg tablets of M/s Valor Pharma which could not be
verified.
Decision: Deferred for evidence of applied formulation/ drug already approved by DRAP (generic / me-
1635. Name and address of manufacturer/ M/s Himont Pharmaceuticals Pvt Ltd, 17-km, Ferozepur Road,
Brand Name + Dosage Form + Strength Tracamol SR Tablets 100mg
Tramadol HCl…………..…100mg
Approval status of product in Reference TGA; Australia Approved as modified- release tablet
Me-too status Tramed- SR Tablets of M/s Platinum Pharma
024458
evaluation done on 04-10-2018 and 05-10-2018.
Previous Remarks of the Evaluator Tablet section is available in the firm as mentioned in the
TGA; Australia Approved as modified- release tablet.
Me- too is also of SR Tablets.
Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) along with registration number, brand
regulatory authorities/agencies which were adopted by the
Evaluation by PEC- XIII Firm has corrected the applied formulation as
Each film- coated sustained- release tablet contains:
Tramadol HCl……………………………100mg
With submission of requisite fees i.e. Rs. 5000/-.

During second evaluation, the reference product has been found as
bilayered tablet in TGA; Australia. So, firm has submitted the
master formulation as modified release bilayered tablet with
evidence of availability of bilayered tablet machine mentioned in
the submitted GMP inspection report dated: 03-07-2009.
1636. Name and address of manufacturer/ M/s Axis Pharmaceuticals, Value Addition City, 3-B, 1.5km,
Applicant Khurrianwala-Sahianwala Road, Faisalabad
Brand Name + Dosage Form + Strength Bandil Suspension 100mg/5ml
Albendazole……………..……………………….100mg
Me-too status Nenzole Suspension of M/s Nenza pharmaceutical Peshawar
025891
GMP status Last GMP inspection was conducted on 19-09-2018 & 03-10-
2018 and the report concludes fair level of GMP compliance and
the panel recommends grant of cGMP certificate.
Previous Remarks of the Evaluator  General oral liquid section is available in the firm as
 International availability could not be confirmed.
available in USP.
Previous decision Deferred in 295th DRB meeting 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- XIII Firm has submitted international reference of EMA as Zentel
100mg/ 5ml susupension of M/s GSK which could not be verified.
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.
1637. Name and address of manufacturer/ M/s Cunningham Pharmaceuticals Pvt Ltd.Plot # 81, Sunder
Applicant Industrial Estate, Raiwind Road Lahore, Pakistan
Brand Name + Dosage Form + Strength Curoxaban 10mg Tablet
Rivaroxaban……………….10mg
Pharmacological Group Anti- thrombotic agent
Me-too status Rivar 10mg Tablet of Hilton Pharma Kar. 081476
concludes good GMP compliance.
gen tablet DML
Applied master formulation is not submitted.
Previous decision Deferred in 295th DRB meeting for the submission of master
formulation of the applied drug.
Evaluation by PEC- XIII Firm has submitted the applied master forrmulation in reply.
1638. Name and address of manufacturer/ M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area,
Brand Name + Dosage Form + Strength Nadal Tablets 80mg
Nadolol………80mg
Pharmacological Group beta blocking agent
Pack size & Demanded Price 1x 10 5x 10 10x 10 & as per SRO
Me-too status Norgar Tablets 80mg Pulse Pharmaceutical, Mozay Badoke,
Raiwind Road Lahore. 052730
GMP status 17-10-2018 the panel unanimously recommends for grant of GMP
certificate.
Previous Remarks of the Evaluator Attached fee- challan is of onscot 2.5mg tablet (Metolazone).
Previous decision Deferred in 295th DRB meeting for clarification that attached fee-
challan is of Onscot 2.5mg tablet (Metolazone).
Evaluation by PEC- XIII Now, the firm has submitted relevant yellow copy of paid fee-
challan under deposit slip # 0803995 against the concerned applied
drug.
Decision: Approved.
1639. Name and address of manufacturer/ M/s Vision Pharmaceuticals, Plot # 22,23, Industrial Triangle,
Brand Name + Dosage Form + Strength Colistin Dry Powder sachet I million IU
Composition Each Vial Contains: lyophilized powder
Colistimethate Sodium……1 Million IU
Me-too status Colistat powder for Injection Medisure Lab, Karachi 076160
GMP status 11-02-2019 the panel recommends the issuance of GMP certificate
to Vision Pharma Islamabad as the firm is found at a good level of
GMP as today.
Previous Remarks of the Evaluator  Sachet is written under the heading of dosage form in
form- 5 while each vial contains is written under the
heading of applied composition. And under the heading of
proposed route of administration injection is written.
 Firm has lyophilized section.
 Are they making powder by themselves or they will refill
the imported powder.
 Clarification of applied dosage form as sachet or injection.
 If injection is applied then clarification is required
regarding lyophilised powder that are they making powder
by themselves or they will refill the powder imported from
outside.
Evaluation by PEC- XIII Firm has submitted the reply as:
 Sachet was written mistakenly. Actually, the applied drug
is a dry powder injection and is filled in vials. Corrected
Form- 5 is submitted.
 We will import the powder in ready to fill containers and
refill in vials only.
Decision: Deferred for submission of requisite fees for change of applied dosage form from sachet to
injection.
1640. Name and address of manufacturer/ M/s Werrick Pharmaceuticals, Plot No. 216-217, I-10/3,
Applicant Industrial Area, Islamabad.
Brand Name + Dosage Form + Strength Flueze Extra Day tablets
Acetaminophen…………………………………..500mg
Phenylephrine hydrochloride……………………….5mg
Diary No. Date of R & I & fee Dy. No. 17521; 09-10-2017; Rs.20,000/- (109-10-2017)
Pharmacological Group Analgesic/ Decongestant
Pack size & Demanded Price 10x10’s, As per SRO
Contac Cold + Flu by Canada
GMP status 21-09-2017; GMP and follow up inspection
Firm is operating at acceptable level of GMP
compliance.
Previous Remarks of the Evaluator International availability and Me too could not be
confirmed.
Previous decision Deferred in 284th DRB meeting as the the local and international
availability of the applied formulation
could not be confirmed.
Evaluation by PEC- XIII  International reference has been verified as Demazin Cold
+ Flu Relief tablet of iNova Pharmaceuticals (Australia)
Pty Ltd TGA; Australia Approved.
 Me- too submitted by the firm has been verified as:
Panadol CF Day Caplet (Paracetamol 500mg and Phenylephrine
HCl 5mg of M/s GSK, Karachi 094797.
 The applied formulation is on stability so firm needs to
submit stability studies data of atleast three batches at
accelerated and real time conditions.
1641. Name and address of manufacturer/ M/s Benson Pharmaceuticals, Plot No. 119, Street # 8, I-10/3,
Applicant Industrial Area, Islamabad.
Brand Name + Dosage Form + Strength Paradol 37.5mg/ 325mg Tablets
Composition Each film-coated tablet contains:-
Tramadol Hydrochloride……………….37.5mg
Acetaminophen………………………….325mg
USFDA Approved
Me-too status Tramadoln Plus Tablet 37.5/ 325mg of M/s Akson Pharma (Reg.
# 085459
GMP status Last GMP inspection was conducted on 13-11-2018 and th
report concludes grant of DML.
Previous Remarks of the Evaluator  Tablet section (General) is available in the firm as
mentioned in the submitted inspection report.
 Firm’s previous address was M/s Benson
Pharmaceuticals, Plot No. 119, Street # 8, I-10/3,
Industrial Area, Islamabad.
 Now, the address has been changed as M/s Benson
Pharmaceuticals, Plot # 3, Main Road, National
Industrial Zone, RCCI, Rawat which is verified by
submitted DML issued by CLB.
Previous decision Deferred in 291st DRB meeting for clarification as DML of the firm
at Plot No. 119, Street # 8, I-10/3, Industrial Area, Islamabad is not
valid.
Evaluation by PEC- XIII  Firm has submitted copy of DML along with DRAP’s
letter confirming the change of premises under same DML
no.
 Copy of GMP certificate is attached.
 Original deposit slip evidencing the payment of additional
fee of Rs. 20,000/- has been submitted by the firm under
deposit slip no. 0827131 dated 08-04-2020.
Decision: Approved.

a. New Cases
1642. Name and address of manufacturer/ M/s Bio Labs Pvt. Ltd, Plot # 145, Industrial Triangle,
Brand Name + Dosage Form + Strength Bio- Clozine 30 Powder
Sulfaclozine Sodium……………………………..…30g
2019
Pharmacological Group Anti- coccidial
Pack size & Demanded Price 250g & Decontrolled
Me- too status E- Cox Oral Powder of M/s Biogen Pharma, Rawat 057033
GMP status The firm has submitted a GMP certificate issued to them on
21st May, 2019 which was based on the inspection and
evaluation conducted on 23-04- 2019.
1643. Name and address of manufacturer/ M/s Bio Labs Pvt Ltd, Plot # 145, Industrial Triangle,
Brand Name + Dosage Form + Strength Bio Lincospec 100 Powder
Lincomycin HCl……….……………………33.3g
Spectinomycin………………………………66.7g
2019
Pack size & Demanded Price 1kg & Decontrolled

Remarks of the EvaluatorXIII  Firm has submitted me- too status in reply as Linco-
spectin 100 Reg. # 009991 of M/s Zoetis, Ghazi
Brothers which could not be verified.
/ me-too status) along with registration number, brand name and name of firm.
Brand Name + Dosage Form + Strength Noxyflor oral powder
Florfenicol…………………………………100mg
Oxytetracycline HCl…………………….…300mg
Neomycin sulphate…………………………150mg
2019
Pack size & Demanded Price 500g, 1kg & Decontrolled
Me- too status E- Col Water Soluble Powder of M/s Evergreen
Pharmaceuticals, Lahore 081733
Brand Name + Dosage Form + Strength Flormax- C Powder
Florfenicol………………………….…………….…23g
Colistin sulphate…………………………………50MIU
2019
Remarks of the EvaluatorXIII  Me- too could not be confirmed as powder.
 Now, the firm wants to change the dosage form from
powder to liquid with following composition:
Florfenicol…………............…………….…23g
Colistin sulphate………..………………50MIU
Decision: Deferred for submission of changed formulation from powder to liquid with submission
of requisite fees.
Brand Name + Dosage Form + Strength Bio- Enro Plus Powder
Enrofloxacin……………………….……….75mg
Sulphamethoxy Pyridazine…………..……..75mg
Sulphamethazine………………..…………….50g
Trimethoprim……………………………….25mg
2019
Remarks of the EvaluatorXIII Firm has submitted in reply the following me- too:
Cina T.S Oral Suspension Vety-Care Pharmaceutical (Pvt)
Ltd., Islamabad 031456; which is of oral suspension, while
they have applied oral powder.
So, me- too status could not be confirmed.
Brand Name + Dosage Form + Strength Bio Fosfotyl Powder
Fosomycin Calcium…....................................20mg
Tylosin tartrate..........................................…100mg
Fructose….....................................................180mg
Sodium Phosphate…………….……………150mg
2019
Remarks of the EvaluatorXIII Firm has submitted the following me- too in reply:
Fosfo- 20 Oral Powder of M/s Evergreen Pharmaceuticals,
Ferozpur Road, Lahore (Reg. # 088861); which could not be
verified.
Brand Name + Dosage Form + Strength Bio Furazone 24.4% Powder
Furazolidone……………………………….24.4%
2019
Pharmacological Group Nitro furans
Pack size & Demanded Price 1kg & Decontrolled
Me- too status Reothin-H Feed Supplement of M/s Delux Chemical
Industries Karachi 023406
Decision: Deferred as formulation is under review.
1649. Name and address of manufacturer/ M/s Wimits Pharmaceuticals (Pvt.) Ltd, Plot No. 129,
Applicant Sundar Industrial Estate, Raiwind Road, Lahore
Brand Name + Dosage Form + Strength Oxycloz Plus Drench
Oxfendazole……………………………………62.50mg
Oxyclozanide…………………………………..22.65mg
Cobalt Sulphate…………………………………1.67mg
Sodium Selenite…………………………………0.50mg
2019
Pack size & Demanded Price 100ml, 150ml, 250ml, 500ml,1000ml & Decontrolled
Me- too status Punch Drench of M/s Selmore Pharma (Pvt) Ltd., Lahore
032206 if each 100ml contains is applied.
report concludes satisfactory GMP compliance of the firm.
Remarks of the EvaluatorXIII Applied as drench while gm/ mg is applied in composition.
 Formulation is applied as drench while gm/ mg is applied in composition.
Brand Name + Dosage Form + Strength Clozasol Gold Drench
Levamisole (HCl)………………………………….3gm
Oxyclozanide………..……………………………..6gm
Cobalt Sulphate……………………………….0.334gm
Sodium Selenite……………………………….…0.1gm
2019
Remarks of the EvaluatorXIII  On application, following formulation is applied:
 Each ml contains:
Oxfendazole……………………………..94mg
Oxyclozanide……………………….……34mg
Cobalt Sulphate……………………..…3.82mg
Sodium Selenite…………………..……0.50mg
 Me- too status could not be confirmed.
along with registration number, brand name and name of firm.
 Different compositions have been applied in different parts of dossier.
Brand Name + Dosage Form + Strength Clozasol Plus Drench
th
Levamisole (HCl)………………………………1.50gm
Oxycloazanide……………………………………..3gm
Cobalt Sulphate…………………………….…0.167gm
Sodium Selenite………………………………...0.05gm
2019
Remarks of the EvaluatorXIII Me- too could not be confirmed.
Brand Name + Dosage Form + Strength Combimit Drench
Oxyclozanide .......................................................94mg
Oxfendazole..........................................................34mg
Cobalt sulphate...................................................3.82mg
Sodium selenite...................................................0.50mg
2019
Me- too status Combiox Drench of M/s Selmore Pharma (Pvt.) Ltd
Multan Road Lahore 057004
Remarks of the EvaluatorXIII On Form- 5, Clozasol Gold Drench brand name is applied
while fee- challan is of Combimit Drench.
Decision: Deferred for applied composition as on Form- 5, “Clozasol Gold Drench” brand name
is applied while fee- challan is of “Combimit Drench”.
Brand Name + Dosage Form + Strength Doximit- C Water Soluble Powder
Colistin Sulphate…...............................25,00,000 IU
Tylosin as Tartrate…......................................100mg
Doxycycline as Hyclate…..............................100mg
Bromhexine as HCl........................................…5mg
2019
Pharmacological Group Mucolytic / Antibiotic
Pack size & Demanded Price As per SRO & Decontrolled
Remarks of the EvaluatorXIII Me- too could not be confirmed.

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.
1654. Name and address of manufacturer/ M/s Divine Pharmaceuticals, Plot No. 226-A, Sundar
Applicant Industrial estate, Lahore.
Brand Name + Dosage Form + Strength Broment Fort (Oral Solution)
Bromhexine HCl………………………….…. 2.5% w/v
Diary No. Date of R & I & fee Dy.No.31029 dated 14-09-2018 Rs.20,000/-Dated 14-09-
2018
Pharmacological Group Mucolytic
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml & Decontrolled
 General Liquid Vet section is available in the firm
as mentioned in the submitted DML.
firm.
Applicant Industrial Estate, Lahore.
Brand Name + Dosage Form + Strength G- Flor Water Soluble Powder
Florfenicol………………………………….. 20% w/w
2017
Pack size & Demanded Price 100g, 250g, 500g, 1kg & Decontrolled
 General Powder Vet section is available in the firm
firm.
Applicant Industrial estate, Lahore.
Brand Name + Dosage Form + Strength G- Flor Plus Water Soluble Powder
Florfenicol………………………………….. 25% w/w
2017
Pharmacological Group Anti- bacterial

Pack size & Demanded Price 100g, 250g, 500g, 1kg & Decontrolled
 General Powder Vet section is available in the firm
firm.
b. Deferred Cases
1657. Name and address of manufacturer/ M/s Nawan Laboratories Pvt Ltd. 136 sector 15 Korangi
Brand Name + Dosage Form + Strength Cefanil IMM injector (Intramammary suspension)
Composition Each 8gm syringe contains:
Cefquinome as Sulfate………………………75mg
Diary No. Date of R & I & fee Dy. No.24004;11-07-2018; Rs.20,000 (10-07-2018)
Pharmacological Group Anti- bacterial
Me-too status Cobac 7.5 % LA Injection of M/s Mylab (Pvt) Ltd.
(Reg. # 073911)
GMP status Last GMP inspection report was conducted on 30-04-018
and the report concludes satisfactory level of GMP
compliance.
Previous Remarks of the EvaluatorXIII  Liquid Injectable Veterinary (Cephalosporin)
section is available in the firm.
Previous decision  Deferred in 291st DRB meeting for confirmation of
manufacturing facility of PFS.
Evaluation by PEC-XIII  Instead of submitting the required query which was
the confirmation of manufacturing facility of PFS,
firm claims that the applied product has another me-
too as “Cobactan LC Intramammary
of M/s ICI Pakistan with Reg. # 078220.”
 The above submitted me- too could not be verified.
Decision: Deferred in 293rd DRB meeting for confirmation of manufacturing facility of Pre- filled
Syringe.
Second Evaluation:
Firm has submitted the following reply.
1- Cefanil IMM Injector (Intramammary Suspension) will be manufactured under aseptic condition
in approved Cephalosporin Sterile Liquid Section Veterinary (copy of section approval
enclosed).
2- The Filling is carried out under laminar flow hood in class 100 in pre-sterilized IMM plastic
Disposable Flexi-Tube using semi auto manual filling machine. During filling fill-weight is
periodically checked and recorded.
3- Packing is carried outside on packaging belt. The IMM Plastic Disposable Flexi-Tubes are
labelled and sealed in polythene bags and finally pack in printed carton.
In the light of above explanation you are request to kindly approve our applied drug “Cefanil
IMM Injector (Intramammary Suspension)”. We hope that you will consider our request in this
regard and for this we shall be very thankful to you.
Decision: Referred to Licensing Division for confirmation of manufacturing facility.

1658. Name and address of manufacturer/ M/s Selmore Pharmaceuticals Pvt Ltd. 36- Km, Multan
Applicant Road Lahore.
Brand Name + Dosage Form + Strength Vital Plus Powder
Vitamin-A…………………………………10 MIU
Vitamin-D3…………………………………3 MIU
Vitamin-E………………………………5000 MIU
Vitamin-K3………………….……….…3000 MIU
Vitamin-C…………………………….30,000 MIU
Diary No. Date of R & I & fee Dy. No.25079; 19-07-2018; Rs.20,000(19-07-2018)
Pharmacological Group Multi- Vitamin
Pack size & Demanded Price 500g, 1kg, 2.5kg & Decontrolled
Approval status of product in Reference N/A
Me-too status Advet Plus Water Soluble Powder of M/s Medicure Labs
(Reg. # 019929)
concludes grant of renewal of DML.
Previous Remarks of the EvaluatorXIII Veterinary Oral powder is available in the firm as is
Previous decision Deferred in 291st DRB meeting for clarification regarding
solubility of vitamins as formulation has both water soluble
and fat soluble vitamins.
Evaluation by PEC-XIII Firm has replied:
“Finished form of the said product is in powder form
not in the liquid form and it is not water soluble but
dispersible.”
1659. Name and address of manufacturer/ M/s Breeze Pharma Pvt. Ltd, Plot No. 125, 126, 127-A,
Applicant Industrial Triangle, Kahuta Road, Islamabad.
Brand Name + Dosage Form + Strength Biodran Powder
Propionic Acid Calcium………………250mg
Propionic Acid Sodium…...…………..250mg
Acetanilide……………………...….…150mg
Magnesium Oxide……...………….….125mg
Iron-II Sulphate……...……………….0.40mg
Magnesium Sulphate……………...….0.20mg
Copper Sulphate………………...……0.10mg
Cobalt Sulphate………………...…….0.40mg
Sodium Chloride………………...……..20mg
Sodium Molybdate……………...……0.10mg
Pharmacological Group Digestive tonic
report concludes reasonable satisfactory level of
compliance. The firm was advised to submit compliance
report within 30 days of inspection.
Previous Remarks of the EvaluatorXIII  General Oral powder section is available in the firm
as mentioned in the submitted GMP inspection
report.

 Firm has submitted the following reference which
could not be verified.
“Diarroban Powder of M/s Star Labs Lahore
(Reg. # 026438).”
formulation/drug already approved by DRAP (generic / me-
too status) along with registration number, brand name and
name of firm.
Evaluation by PEC-XIII  Firm has now changed its applied formulation as :
Each 12gm Water soluble powder contains:
Neomycin sulphate………………….…400mg
Streptomycin sulphate………………....400mg
Sulphaguanidine…………………………....4g
Vitamin-A Acetate………………….80,000 IU
Kaolin……………………………………... 4g
Pectin…………………………………. 400mg
Bismuth subnitrate…. ……………………...2g
 Firm has submitted Rs. 20,000/-dated 27-08-2020
under deposit slip # 2032154 for change of
formulation.
 Applied pack size is now 100g, 250g, 500g, 1kg,
5kg, 10kg, and 25kg.
 Verified me- too is Diarroban powder of Star Labs
Reg. # 026438.
Decision: Registration Board rejected the case firm has changed its application wrt ingredients.
1660. Name and address of manufacturer/ M/s Breeze Pharma Pvt. Ltd, Plot No. 125, 126, 127-A,
Brand Name + Dosage Form + Strength Ivoron Super Gold Injection I/M, I/V, S/C
Ivermectin……………………………20mg
Clorsulon……………………………100mg
Previous Remarks of the EvaluatorXIII  General injection section is available in the firm as
 Firm has submitted the following me- too but it
could not be verified:
“Iver Gold Super Injection of M/s Cherished
Pharmaceuticals, Lahore (Reg. # 058806.”
me-too status) along with registration number, brand
Evaluation by PEC-XIII  Firm has now changed its applied formulation as :
Ivoron Super Gold Injection I/M, S/C
Each ml contains:
Ivermectin… 20mg
Clorsulon….. 10mg
 Firm has submitted Rs. 20,000/-dated 27-08-2020
under deposit slip # 2032153 for change of
formulation.
 Applied pack size is now 50ml.
 Verified me- too is Ivoclor injection of Nawal
Pharma Reg. # 078244.
1661. Name and address of manufacturer/ M/s Breeze Pharma Pvt. Ltd, Plot No. 125, 126, 127- A,
Brand Name + Dosage Form + Strength Clobendol- 12 Drench
Albendazole………………………….…10gm
Closental…………………………………2gm
Previous Remarks of the Evaluator XIII
 General Oral liquid section is available in the firm
as mentioned in the submitted GMP inspection
report.
me-too status) along with registration number, brand
Evaluation by PEC-XIII  Firm has submitted the following me- too that has
been verified as:
“Clobendol Suspension of M/s Vety- Care Pharmaceuticals
(Pvt.) Ltd., Islamabad (Reg. # 028523)”.
1662. Name and address of manufacturer/ M/s Noa Hemis Pharmaceuticals, Plot No. 154, Sector-23,
Applicant Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength Tylodoxin Plus Soluble Powder
Tylosin Tartrate……………………………200gm
Doxycycline HCl………………………..…400gm
Colistin sulphate……………………...…500 MIU
Bromhexine HCl…………………………..…5gm
Diary No. Date of R & I & fee Dy.No 1887 dated 15-01-2019 Rs.20,000/- Dated 15-01-
2019
Type of Form Form-5
Pack size & Demanded Price 250g, 500g, 1kg, 2.5kg, 5kg & Decontrolled
the report concludes that the firm was considered to be
operating at an acceptable level of compliance to the
cGMP.

Previous Remarks of the EvaluatorXIII Firm has vet powder Antibiotic section as mentioned in the
submitted GMP inspection report
formulation/ drug already approved by DRAP (generic /
me-too status) along with registration number, brand name
and name of firm.
Evaluation by PEC-XIII Firm has changed its applied formulation as follows:
Tylosin Tartrate……………………………200gm
Doxycycline HCl………………………..…400gm
Colistin sulphate……………………...…500 MIU
Bromhexine HCl………………………....…10gm
Following me- too has been verified for the changed
formulation:
Dox- 40 water soluble powder of M/s Nawal Pharma,
Taxilla, Rawalpindi Reg. # 074096.
Firm has submitted Rs. 5000/- fees under slip # 0798068
dated: 26-08-2020 for revision of formulation.
Decision: Deferred for submission of differential fees for revision of strength of Bromhexine HCl.
Brand Name + Dosage Form + Strength CNF-250 Soluble Powder
Chlortetracycline HCl………………………..100gm
Neomycin Sulphate……………………………30gm
Furaltadone HCl……………………………….75gm
2019
Type of Form Form-5
Me-too status Trifle Powder Selmore Pharmaceuticals (Pvt) Ltd., Lahore
029615
cGMP.
Previous Remarks of the Evaluator XIII
 Neomycin “as” Sulphate is available in me- too.
 Firm has vet powder Antibiotic section as
Previous decision Deferred in 295th DRB meeting as “Neomycin Sulphate” is
applied while it is approved as Neomycin “as” Sulphate.
Evaluation by PEC-XIII Firm has corrected the applied composition in reply as
“Neomycin as Sulphate.”
Decision: Deferred for Furaltadone containing formulations are under review.
Brand Name + Dosage Form + Strength Noaflox- Plus Soluble Powder
Florfenicol…..............................................150gm
Chlortetracycline HCl…............................150gm
2019
Type of Form Form-5

cGMP.
Previous Remarks of the EvaluatorXIII Me- too could not be confirmed
Firm has vet powder Antibiotic section as mentioned in the
name of firm.
Florfenicol…………………….………...150gm
Oxytetracycline HCl….……….………...150gm
formulation:
Enteroflor oral powder of M/s Hawk Bio Pharma,
Rawat, Islamabad Reg. # 078399.
Firm has submiited Rs. 5000/- fees under slip # 0798069
Decision: Registration Board rejected as firm has changed its application as Chlortetracycline
HCl has been changed with Oxytetracycline HCl.
Brand Name + Dosage Form + Strength Noaflotin Oral Solution
Florfenicol…23gm
Colistin Sulphate…50 MIU
2019
Type of Form Form-5
Pack size & Demanded Price 500ml, 1 litre & Decontrolled
Me-too status Flotin Liquid D-Maarson Pharmaceuticals, Plot # 17, Street
SS-2, National Industrial Zone, Rawat, Islamabad. 072680
cGMP.
Previous Remarks of the EvaluatorXIII Oral liquid vet section needs to be verified.
Previous decision Deferred in 295th DRB meeting for confirmation of required
manufacturing facility / section from Licensing Division.
Evaluation by PEC-XIII Oral Liquid Syrup Vet section is available in the firm as
Brand Name + Dosage Form + Strength Noa- Esel Super Oral Solution
Vitamine E……………………….15gm
Sodium Selenite Pentahydrate…0.20gm
Vitamin C……………………....0.40gm

Zinc Sulphate…………...…………1gm
2019
Pharmacological Group Immunity booster veterinary preparation
Type of Form Form-5
Pack size & Demanded Price 500ml, 1 litre & Decontrolled
cGMP.
Firm has oral liquid syrup section as mentioned in the
submitteed GMP inspection report.
manufacturing facility / section from Licensing Division.
Firm has changed its applied formulation as follows:
Each 100ml Contains:
Vitamine E……………………….20gm
Sodium Selenite Pentahydrate…0.20gm
Zinc Sulphate………………….0.90gm
Following me- too submiited by firm has been verified as:
Sel- E Solution of M/s Noble Pharma Reg. # 063641.
Decision: Registration Board rejected the case firm has changed its application and excluded
Vitamin C from the applied formulation.
Brand Name + Dosage Form + Strength Noaflox- Excel Soluble Powder
Chlortetracycline HCl…………………………….300gm
Neomycin Sulphate…………………………….…150gm
Florfenicol………………………………………...100gm
2019
Type of Form Form-5
cGMP.
Firm has vet powder antibiotic section as mentioned in the
name of firm.
Oxytetracycline HCl….………………….300gm
Neomycin Sulphate………...………….…150gm
Florfenicol…………………….………...100gm.
formulation:
Vety Flor Mix Powder of M/s Leads Pharma, Islamabad
(Reg. # 094484).
Decision: Registration Board rejected the case as an ingredient Chlortetracycline HCl has been
changed as Oxytetracycline HCl.
Brand Name + Dosage Form + Strength CNF Super Soluble Powder
Chlortetracycline…400gm
Neomycin Sulphate…120gm
Furaltadone HCl…300gm
2019
Type of Form Form-5
Me-too status N.C.Bak Water Soluble Powder of M/s Attabak
Pharmaceuticals Islamabad. 053905
cGMP.
Previous Remarks of the EvaluatorXIII  Firm has vet powder antibiotic section as
mentioned in the submitted gmp inspection report.
 Neomycin “as” Sulphate Is Available In Me- Too.
Previous decision Deferred in 295th DRB meeting as “Neomycin Sulphate” is
applied while it is approved as Neomycin “as” Sulphate.
Evaluation by PEC-XIII Firm has corrected the applied composition in reply as
“Neomycin as Sulphate.”
Decision: Deferred as Furaltadone containing formulation are under review.
Brand Name + Dosage Form + Strength Tylodoxin-Excel Oral Solution
Tylosin Tartrate…20gm
Colistin sulphate…50 MIU
Bromhexine hcl…500mg
2019
Type of Form Form-5
cGMP.

Previous Remarks of the EvaluatorXIII  Me- too could not be confirmed.
 Oral liquid vet section needs to be verified.
approved by DRAP (generic / me-too status) along
with registration number, brand name and name of
firm.
 Confirmation of required manufacturing facility /
section from Licensing Division.
mentioned in the submittred section approval letter.
Each 100ml Contains:
Tylosin Tartrate…20gm
Doxycycline HCl…20gm
Colistin sulphate…50 MIU
Bromhexine HCl…0.5g
formulation:
1. CRD Mars Liquid of M/s D- Maarson Pharma,
Islamabad (Reg. # 072677).
Firm has submitted Rs. 5000/- fees under slip # 0798072
Decision: Deferred for submission of remaining requisite fees for revision of applied strength of
Doxycycline HCl.
Brand Name + Dosage Form + Strength Noatil-250 Oral Solution
Tilmicosin…….25gm
2019
Type of Form Form-5
Pack size & Demanded Price 100ml, 200ml, 500ml, 1 litre & Decontrolled
Me-too status Hicos 250 Oral Solution Hilton Pharma (Pvt) Ltd., Karachi
044909
report concludes that the firm was considered to be operating
at an acceptable level of compliance to the cGMP.
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Previous Remarks of the Evaluator Oral liquid vet section needs to be verified.
manufacturing facility /section from Licensing Division.
mentioned in the submittred section approval letter.
Brand Name + Dosage Form + Strength Noaflor-30 Oral Solution
Florfenicol……30gm
2019
Type of Form Form-5
cGMP.
Previous Remarks of the EvaluatorXIII  Oral liquid vet section needs to be verified.
 Me- too could not be confirmed.
 Confirmation of required manufacturing facility /
section from Licensing Division.
firm.
Noaflor- 25 Oral Solution
Florfenicol…..25gm
formulation:
1. Nobiflor 25% Liquid of M/s Noble Pharma, AJK
(Reg. # 063639).
Decision: Deferred for submission of differential requisite fees for revision of strength of
Florfenicol.
Priority Approval / Registration of Drugs during the COVID-19 Pandemic:
The world is currently facing one of the biggest public health outbreaks of coronavirus disease 2019 (COVID-
19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The outbreak was
first identified in Wuhan, Hubei, China, in December 2019. The World Health Organization (WHO) declared
the outbreak to be a Public Health Emergency of International Concern on 30th January 2020 and recognized
it as a pandemic on 11th March 2020. More than 723,500 cases of COVID-19 have been reported in over 190
countries and territories, resulting in approximately 34,000 deaths till date.
Many clinical trials are under way for treatment / prevention of COVID-19 which uses different type of
pharmaceutical / biological drugs. Many drugs have been allowed for investigational use in hospitals under
medical care for the COVID-19 patients.
The authorities from all over the world have considered the use of several drugs under their respective national
emergency management plans. Clinical Management Guidelines for COVID-19 Infections issued by Ministry
of National Health Services, Regulation & Coordination (available at http://covid.gov.pk/guideline) also
recommends the use of these drugs in the management of mild to moderate and severe cases of COVID-19
patients. Further, USFDA has also given Emergency Use Authorization for chloroquine and
hydroxychloroquine tablets for COVID-19 patients (available at:
https://www.fda.gov/media/136534/download). Further Centers for disease control and prevention (CDC)
USA also issued Information for Clinicians on Therapeutic Options for Patients with COVID-19 (available at:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html). Similarly Italian Medicines
Agency (AIFA) considers it essential to provide clinical elements useful to guide the prescription and to define,
for each drug used, a relationship between benefits and risks for the individual patient. Off-label use is only
permitted under the national emergency management plan for treatment of COVID-19 by using Lopinavir /
ritonavir (available at: https://www.aifa.gov.it/emergenza-covid-19).

Keeping in view the above information, Drug Regulatory Authority of Pakistan (DRAP), exercising its powers
under Rule 26of Drugs (LRA) Rules amended via SRO 713(1)/2018 dated 8th June, 2018, has made following
decision in its meeting dated 3rd April, 2020.
1. Allowed to submit registration application on form 5, form 5A, form 5D or form 5E instead of form
5F for following formulations as approved by the reference regulatory auhtories;
a. Chloroquine Phosphate
b. Hydroxychloroquine Sulfate
c. Lopinavir/Ritonavir
d. Oseltamivir
e. Ascorbic Acid
2. The applicant can submit their application till 2nd May 2020 but the date was extended till 5th May,
2020 vide letter No.F.76-DRAP/2020(PE&R) dated 30th April, 2020.
3. These applications will be considered out of queue.
4. The validity of registration period for above mentioned drugs registered during this time will be one
only.
5. The registration holder will submit data of product development of 3 and 6 months within one year.
The data will be considered by Registration Board for extension of validity period of registration for
further period.
6. Applicant shall submit affidavit for compliance of point and 5 above.
The Authority further extended the time lines till 31-07-2020 for submission of registration applications on
Form 5 / Form 5-A / Form 5-D for molecules already approved by the Authority for the management of Covid-
19.
1672. Name and address of manufacturer/ M/s Delta Pharma Pvt Ltd. Plot. No. 9, Nowshera Industrial Estate,
Applicant Risalpur, Kpk, Pakistan
Brand Name + Dosage Form + Strength Delquine 250mg Tablet
Chloroquine Phosphate……250mg
Diary No. Date of R & I & fee Dy.No.13132 dated 12/05/2020Rs. 20,000/- dated 09-06-2020
Approval status of product in Reference Approved by US FDA
Me-too status Resochin 250mg Tab by M/s Bayer Karachi.
GMP status 15-08-2017 Grant of DML for Gen Tab And Cap Sections Only
Decision: Approved.
1673. Name and address of manufacturer/ M/s Bio Labs Pvt Ltd, Plot # 145, Industrial Triangle, Kahuta
Brand Name + Dosage Form + Strength Eniqor 500mg Tablet
Diary No. Date of R & I & fee Dy.No.13662 dated 15/06/2020; Rs. 50,000/- dated 15-06-2020
GMP status 23-04-2019 and the report concludes reasonably acceptable
Remarks of the EvaluatorXIII Tab gen section is available as mentioned in GMP inspection
report
Decision: Approved.

1674. Name and address of manufacturer/ M/s Pharmevo Private Limited, Plot # A-29, North Western
Applicant Industrial Zone, Port Qasim, Karachi
Brand Name + Dosage Form + Strength Evoquin Tablet 150mg
Form 5
Me-too status Could not be confirmed.
GMP status 07-02-2019 issuance of GMP certificate.
Remarks of the EvaluatorXIII Fee- challan is of 150mg and in Form- 5, 300mg is mentioned.
And in applied master formulation strength is mentioned as
250mg.
Me-too status could not be verified.
International reference could not be verified.
Evidence of approval of applied formulation in reference regulatory authorities which were adopted
by Registration Board in its 275th meeting.
1675. Name and address of manufacturer/ M/s Citi Pharma Pvt Ltd., 3-km Head Balloki, Phool Nagar District
Applicant Kasur, Pakistan
Brand Name + Dosage Form + Strength Chloronil 250mg Tablet
Chloroquine Phosphate…...250mg
Form 5
Me-too status Resochin 250mg tablet of M/s Bayer (Reg. # 000025)
GMP status 19-03-2019 renewal of DML for gen tab section
Decision: Approved.
1676. Name and address of manufacturer/ M/s High-Q Pharmaceuticals, Plot No.224, Sector 23, Korangi
Brand Name + Dosage Form + Strength Oclor 500mg Tablet
Eq. to Chloroquine Base.…300mg
Diary No. Date of R & I & fee Dy.No. 14297 dated 22/06/2020Rs. 50,000/- dated 22-06-2020
Form 5D
GMP status GMP certificate granted on the basis of evaluation done on 15-
02-2019.
Brand Name + Dosage Form + Strength Oclor 250mg Tablet
Chloroquine Phosphate ……………………250mg
Form 5
Me-too status RESOCHIN 250MG TAB by M/s Bayer Karachi, (Reg. No.
000025)
02-2019.
Decision: Approved.
1678. Name and address of manufacturer/ M/s Unison Chemical Works Post Office Araian, 15 Km Raiwind
Applicant Road Lahore Pakistan
Brand Name + Dosage Form + Strength Nevquin-P 50mg/5ml Syrup
Chloroquine Phosphate Eq. to Chloroquine…50mg
Form 5
Pack size & Demanded Price 60ml, 120, 450ml & As per SRO
Me-too status Malaquin syrup of M/s Rakaposhi Pharmaceutical Ltd.,
Peshawar having registration no. 034687
GMP status 19-11-2011 Renewal of DML
Remarks of the EvaluatorXIII Gen syrup GMP certificate
Brand Name + Dosage Form + Strength Oclor 50mg/5ml Syrup
Chloroquine Phosphate…80mg
Eq. to Chloroquine Base…50mg
Form 5

Me-too status Malaquin syrup of M/s Rakaposhi Pharmaceutical Ltd.,
Peshawar having registration no. 034687
02-2019.
Decision: Approved.
1680. Name and address of manufacturer/ M/s Nabiqasim Industries Pvt Ltd.17/24, Korangi Industrial
Brand Name + Dosage Form + Strength Inzivir 30mg Capsule
Oseltamivir Phosphate Eq. to Oseltamivir…30mg
Type of Form Form- 5D
Approval status of product in Reference Tamiflu 30mg capsule (oseltamivir as phosphate) by M/s
Regulatory Authorities Roche, USFDA Approved
GMP status 05-08-2019 acceptable level of compliance of GMP.
XIII
1681. Name and address of manufacturer/ M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi Industrial
Brand Name + Dosage Form + Strength Inzivir 45mg Capsule

Approval status of product in Reference Tamiflu 45mg capsule (oseltamivir as phosphate) by M/s
Regulatory Authorities Roche, USFDA Approved
Me-too status --
GMP status 05-08-2019 and acceptable
Remarks of the EvaluatorXIII Firm has capsule gen section according to submitted DML.
Decision: Approved.
1682. Name and address of manufacturer/ M/s Nabiqasim Industries Pvt Ltd.17/24, Korangi Industrial Area,
Applicant Karachi, Pakistan
Brand Name + Dosage Form + Strength Inzivir 6mg/ml Oral Suspension (Dry powder)
Composition Each ml of Reconstituted Suspension Contains:
Approval status of product in Reference Tamiflu 6mg/ml for Suspension (oseltamivir as phosphate) by
Regulatory Authorities M/s Roche, USFDA Approved.
Me-too status Osemvir Powder for Oral Suspension (60mg/5ml) by M/s
Brookes Pharmaceutical, reg. No. 42290
GMP status 05-08-2019 and acceptable
XIII

Decision: Deferred for confirmation of required manufacturing facility / section “Dry Powder
suspension” from Licensing Division.
1683. Name and address of manufacturer/ M/s Wilshire Laboratories Pvt Ltd., 124/1, Quaid-e-Azam
Applicant Industrial Estate, Kot Lakhpat, Lahore
Brand Name + Dosage Form + Strength Pronto 6mg/ml Suspension
Oseltamivir…6mg
Form 5D
Approval status of product in Reference Tamiflu 6mg/ml for Suspension (oseltamivir as phosphate) by
Regulatory Authorities M/s Roche, USFDA Approved.
Me-too status Osemvir Powder for Oral Suspension (60mg/5ml) by M/s
Brookes Pharmaceutical, reg. No. 42290
GMP status 08-08-2019 Acceptable
Remarks of the EvaluatorXIII Section needs to be confirmed.
Decision: Deferred for confirmation of required manufacturing facility / section “Dry Powder
suspension” from Licensing Division.
1684. Name and address of manufacturer/ M/s The Searle Company Limited, 32 Km, Multan Road, Lahore
Applicant
Brand Name + Dosage Form + Strength Ritohi Oral Solution 80/20mg
Composition Each oral solution contains:
Lopinavir…80mg
Ritonavir…20mg
Diary No. Date of R & I & fee Dy.No. 8843 dated 23/04/2020Rs. 20,000/- dated. 23-04-2020
Form 5
Approval status of product in Reference Kaletra Oral Solution 80mg/20mg by M/s Abbvie, USFDA
Me-too status Kaletra Oral Solution 80mg/20mg By M/S Abbott, Reg No.
28427
Decision: Approved.
1685. Name and address of manufacturer/ M/s Epharm Laboratories, A-40, Road No. 1, S.I.T.E. Super
Applicant Highway Industrial Area, North Karachi
Brand Name + Dosage Form + Strength Lorivir Oral Solution 80/20mg
Lopinavir…80mg
Ritonavir…20mg
28427
GMP status 12-09-2019 good
Decision: Approved.
1686. Name and address of manufacturer/ M/s Nimrall Laboratories Plot 24, Street SS-3, Rawat,
Applicant Industrial Area, Islamabad
Brand Name + Dosage Form + Strength Lopivir Oral Solution 80/20mg
Lopinavir…80mg
Ritonavir…20mg
Diary No. Date of R & I & fee Dy.No.7792 dated 16/04/2020Rs. 20,000/- dated. 16-04-2020
Pack size & Demanded Price 60ml, 120ml, 160ml & As per SRO
28427
GMP status 24-07-2019 and report concluded that the rectification of
observations report may be forwarded to competent authority fir
resumption of production activities.
Decision: Approved.
1687. Name and address of manufacturer/ M/s Winlet Pharmaceuticals, 30-km, Lahore Sargodha Road,
Applicant Lahore
Brand Name + Dosage Form + Strength Loprit Oral Solution 80/20mg
Lopinavir……………80mg
Ritonavir…………….20mg
Form 5
Me-too status Kaletra Oral Solution 80mg/20mg by M/s Abbott, Reg No.
28427
GMP status 12-12-2017 and grant of DML including liquid syrup gen section
Remarks of the EvaluatorXIII Gen liquid syrup section DML.
1688. Name and address of manufacturer/ M/s Pearl Pharmaceuticals, Plot No. 204, Street No.1, I-10/3,
Applicant Islamabad
Brand Name + Dosage Form + Strength Rilovir Oral Solution 80/20mg
Lopinavir…80mg
Ritonavir…20mg
Form 5
28427
Remarks of the EvaluatorXIII Gen syrup section GMP report.
Decision: Approved.
1689. Name and address of manufacturer/ M/s Medisave Pharmaceuticals, Plot 578-579, Sundar Industrial
Applicant Estate, Lahore, Pakistan
Brand Name + Dosage Form + Strength Ritomid oral solution 80/20mg
Lopinavir…80mg
Ritonavir…20mg
Diary No. Date of R & I & fee Dy.No.7772 dated 16/04/2020Rs. 20,000/- dated. 16-04-2020
28427
Remarks of the EvaluatorXIII Gen oral liquid section GMP report
Decision: Approved.
1690. Name and address of manufacturer/ M/s Wilshire Laboratories Pvt Ltd.124/1, Quaid-e-Azam
Brand Name + Dosage Form + Strength Ripavir 200/50 mg Tablet
Lopinavir…200mg
Ritonavir…50mg
Form 5
Approval status of product in Reference Kaletra (200mg/50mg & 100mg/25mg) Film coated tablet by
Regulatory Authorities M/s Abbvie, USFDA Approved
Me-too status Lopinavir/Ritonavir Tablets 200mg/50mg By M/S Scitech
Health (Private) LIMITED, Reg No. 62250
Remarks of the EvaluatorXIII Gen tab GMP certificate
Decision: Approved.
1691. Name and address of manufacturer/ M/s Wilshire Laboratories Pvt Ltd. 124/1, Quaid-e-Azam
Brand Name + Dosage Form + Strength Ripavir 100/25 mg Tablet
Lopinavir…..100mg
Ritonavir……25mg
Brand Name + Dosage Form + Strength Covik 200mg Tablet
Hydroxychloroquine Sulphate………200mg
Form 5
Approval status of product in Reference PLAQUENIL 200mg film coated tablet by M/s Concordia,
Me-too status HCQ 200 Tablets by M/s Getz Pharma, Reg. No. 045471
02-2019.
XIII
Remarks of the Evaluator Gen tab GMP certificate
Decision: Approved.
Brand Name + Dosage Form + Strength Covik 400mg Tablet
Hydroxychloroquine Sulphate………400mg
Form 5
02-2019.
with registration number, brand name and name of firm.
1694. Name and address of manufacturer/ M/s Neutro Pharma (Pvt) Ltd. 9.5 km, Sheikhupura Road,
Applicant Lahore.
Brand Name + Dosage Form + Strength Neu-C 1000mg/5ml Injection
Composition Each 5ml Vial contains:
Ascorbic Acid…………………………………...1000mg
Diary No. Date of R & I & fee Dy.No. 16428 dated 08/07/2020 Rs. 50,000/- dated 08-07-2020
Pharmacological Group Anti- oxidant
Approval status of product in Reference Approved by AIFA of Italy
Me-too status Not available in the applied strength as 500mg/ 5ml is
available.
GMP status 28-02-2019 and the report concludes fair level of GMP
compliance.
XIII
Remarks of the Evaluator Gen injection section GMP certificate.
1695. Name and address of manufacturer/ M/s Innvotek Pharmaceuticals, 35-Industrial Triangle, Kahuta
Brand Name + Dosage Form + Strength Immo-C 500mg Tablet
Ascorbic Acid…500mg
Me-too status Cecon-500 (Chewable) Tab Vitamin C 500mg of M/s Abbott
Khi 006119
GMP status Last GMP inspection conducted on 09-03-2017 and the
report concludes that viewing the facts the company is
following the GMP guidelines as of today.
Decision: Approved.
1696. Name and address of manufacturer/ M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial Area,
Brand Name + Dosage Form + Strength Seha 500mg Chewable Tablet
Ascorbic Acid………….500mg
Me-too status Cecon- 500 (Chewable) Tab Vitamin C 500mg of M/s Abbott
Khi 006119
GMP status Grant of GMP certificate on the basis of evaluation done on 22-
11-2019.
XIII
Remarks of the Evaluator Gen tab GMP certificate
1697. Name and address of manufacturer/ M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205, Industrial
Brand Name + Dosage Form + Strength Cebion 500mg Tablet
Ascorbic Acid…500mg
Form 5
Pack size & Demanded Price 10’s x 10’s & As per SRO
Khi 006119
GMP status 26-12-2018 Renewal of DML
Remarks of the EvaluatorXIII General tablet section GMP certificate.
Decision: Approved.
1698. Name and address of manufacturer/ M/s Global Pharmaceuticals Pvt Ltd, Plot # 204-205, Industrial
Brand Name + Dosage Form + Strength Cebion 1g Tablet
Ascorbic Acid………………………………...1000mg
Diary No. Date of R & I & fee Dy. No. 13959 dated 17/06/2020Rs. 20,000/- dated 17-06-2020
Form 5
Approval status of product in Reference Approved by AIFA of Italy as Effervescent tablets
Me-too status C- 1000 effervescent tablets of M/s Werrick (025425)
GMP status 26-12-2018 Renewal of DML.
Remarks of the EvaluatorXIII General tablet section GMP certificate.
In reference and me- too effervescent tablets are approved while
applied ones are simple tablets.
Brand Name + Dosage Form + Strength Citro-C 500mg Tablet
Ascorbic Acid…………..500mg
Form 5
Khi 006119
02-2019.
Decision: Approved.
1700. Name and address of manufacturer/ M/s Maxitech Pharma Pvt Ltd, Plot No. E-178, S.I.T.E. Super
Applicant Highway, Phase II, Karachi
Brand Name + Dosage Form + Strength Cee- Max 500mg/5ml Injection I/M, I/V
Composition Each Ampoule Contains:
Ascorbic Acid…500mg/5ml
Form 5
Pack size & Demanded Price 50 ampoules x 5ml & As per SRO
Me-too status Ascorbic Acid 500 Mg Inj by M/s Schazoo
GMP status 21-02-2019 and good
Remarks of the EvaluatorXIII Sterile liquid injection ampoule section is available in the firm
as mentioned in the submitted GMP inspection report.
Decision: Approved.
1701. Name and address of manufacturer/ M/s Rasco Pharma, 5.5 Km, Raiwind Road, Lahore.
Applicant
Brand Name + Dosage Form + Strength Ras- C 500mg Chewable Tablet
Form 5
Me-too status Cecon-500 (Chewable) Tab Vitamin-C 500mg of M/s Abbott
Khi 006119
GMP status 04-02-2019 renewal of DML
Remarks of the EvaluatorXIII  Initially, On Form- 5 in label claim firm had written
chewable tablet while in master formulation they had
applied film- coating.
 Now, the firm has revised the applied master
formulation according to the reference excluding film-
coating and has submitted Rs. 5000/- fees for revision of
formulation.
Decision: Approved.
1702. Name and address of manufacturer/ M/s Delta Pharma Pvt Ltd., Plot. No. 9, Nowshera Industrial
Applicant Estate, Risalpur, Kpk, Pakistan
Brand Name + Dosage Form + Strength Delvit- C 500mg Tablet
Ascorbic Acid…………….500mg
Form 5
Approval status of product in Reference Approved in MHRA as uncoated tablet
Khi 006119
Remarks of the EvaluatorXIII Approved in MHRA as uncoated while applied as film- coated
tablet.
Gen tab section DML.
GMP report needs to be submitted.
drug is uncoated tablet, while the applied drug is film- coated tablet.
firm.
1703. Name and address of manufacturer/ M/s Avensis Pharmaceuticals, F-24/1, Estern Industrial Zone, Port
Applicant Qasim, Karachi, Pakistan
Brand Name + Dosage Form + Strength Avence- C injection 500mg/ 5ml
Ascorbic acid ……..500mg
Pharmacological Group Neutraceutical
Pack size & Demanded Price 5ml ampoules x 50’s & As per SRO
Me-too status Ascorbic Acid 500 mg by M/s Schazoo
GMP status 31-12-2018 and new DML.
Decision: Approved.
1704. Name and address of manufacturer/ M/s Aneeb Pharmaceuticals Pvt Ltd., 24-Km Bedian Road,
Brand Name + Dosage Form + Strength Orbic- C 500 Tablet
Ascorbic Acid…………………………………..500mg
Pack size & Demanded Price 1x 30’s & Rs. 15/ tab
Khi 006119
GMP status 29-10-2018 renewal of DML for gen tab and cap section only
1705. Name and address of manufacturer/ M/s Iceberg Pharmaceuticals Pvt Ltd., Plot No. 144, Nowshera
Applicant Indsutrial Estate, Risalpur, Kpk, Pakistan.
Brand Name + Dosage Form + Strength Icecon Chewable 500mg Tablet
Khi 006119
GMP status 03-02-2020 and the report concludes resumption of production
of activities in all sections.
1706. Name and address of manufacturer/ M/s Pharmedic Laboratories Pvt Ltd.,16-km, Multan Road Lahore,
Applicant Pakistan
Brand Name + Dosage Form + Strength Pharmedic Vitamin C 500mg Tablet
Ascorbic Acid……………….500mg
Form 5

Khi 006119
GMP status Last GMP inspection was conducted opn 04-02-2020 and the
report concludes satisfactory level of GMP.
Brand Name + Dosage Form + Strength Wel- C 1000mg tablets
Composition Each effervescent tablet contains:
Ascorbic Acid…….….....1000mg
Diary No. Date of R & I & fee Dy.No.15442 dated 30/06/2020 Rs. 20,000/- dated 30-06-2020
Form 5
Type of Form Form-5
Approval status of product in Reference 1 g Effervescent Tablets of M/s Dompe Farmaceutici SPA
Regulatory Authorities Approved by AIFA of Italy
Me-too status C- 1000 Effervescent Tablets of M/s Werrick Pharma Industrial
Area, Islamabad.
Decision: Approved.
Agenda of Evaluator PEC-XIV
Review of Formulation of Orlistat with reference to Stability of the Product:

1. Status of Orlistat Capsule in RRA:
In reference regulatory authorities such as EMA and USFDA, the formulation is approved in in 60mg and
120mg Hard Gelatin Capsule. Study of innovator product (Xenical) shows that it is presented as a conventional
hard gelatin capsule (size 1) containing pellets with an active substance concentration of 50%. The excipients
cellulose microcrystalline (as diluent and extrusion/spheronisation aid), sodium starch glycollate (as
disintegrant), sodium lauryl sulphate (as wetting agent), povidone K30 (as binder and stabiliser), and talc is
added (for lubrication) to the pellets before encapsulation.
2. Assessment Report of European Medicine Agency (EMA), Procedure No. EMEA/H/C/000854/X/10
states that
Stability of the Product:
The stability studies were conducted according to the relevant ICH guidelines. 9 batches of product stored in
the proposed marketing containers (with desiccant) for periods up to 36 months at 25°C/60%RH, 30°C
60%RH., 30°C /65%RH and 40°C /75%RH. It is important to underline that Orlistat has poor chemical
stability at 40°C due to a low melting range (42 - 44°C) of the active substance. Based on the available stability
data, the proposed shelf life is acceptable.
Hence, Stability conditions as per ICH guidelines are:
30°C ± 2°C / 65% RH ± 5% (Intermediate)
25°C ± 2°C / 65% RH ± 5% (Long term)
ICH in its guideline 2.1.7.1 (General case) also recommends the following *It is up to the applicant to decide
whether long term stability studies are performed at 25 ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ±
5% RH.
**If 30°C ± 2°C/65% RH ± 5% RH is the long-term condition, there is no intermediate condition.

3. Conclusion:
As Pakistan is in climatic Zone IVA where the requirement of long-term stability is already 30°C ± 2°C / 65%
RH ± 5%, so according to above evidences and keeping in view of orlistat poor chemical stability at 40°C due
to a low melting range (42 - 44°C) of the active substance there will be no accelerated stability studies of
orlistat at 40°C ± 2°C/75% RH ± 5% RH. Hence, it is advisable to accept stability data on intermediate
condition on 30°C ± 2°C/65% RH ± 5% RH as per ICH stability guidelines. Moreover, degradation studies of
pellets at long term stability conditions should be mandatory.
(Reference Link: https://www.ema.europa.eu/en/documents/scientific-discussion/xenical-epar-scientific-
discussion_en.pdf)
https://www.ema.europa.eu/en/documents/variation-report/alli-h-c-854-x-0001-epar-assessment-report-
extension_en.pdf.
https://www.ema.europa.eu/en/medicines/human/EPAR/alli.
https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.
Discussion: Registration board deliberated the stability of orlistat API and pellets through various
review documents, public assessment reports and already submitted data by the firms. Registration
Board observed that orlistat has poor chemical stability at 40 oC due to low melting range (42oC -
44oC) and degradation products exceed the limits at different time points during stability studies.
Decision: Keeping in view the stability of the orlistat pellets, Registration Board directed the
applicants (drug product manufacturers) to submit the 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.

a. New cases
1708. Name and address of manufacturer / Applicant: M/s Stallion Pharmaceuticals (Pvt.) Ltd., 581-
Applicant Sundar Industrial Estate, Lahore
Contract manufacturer: M/s English Pharmaceutical
Industries, Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore
Brand Name +Dosage Form + Strength STAZON 1g INJECTION IV
Ceftriaxone as sodium……………..1gm
Diary No. Date of R& I & fee 3502, 25-01-2019, 50,000/-, 25-01-2019
Pharmacological Group Cephalosporin antibiotic
Type of Form Form-5
Finished product Specification The firm has claimed BP specifications
Me-too status Rezone 1gm Injection IV by M/s Well Care
Pharmaceuticals, Islamabad. (Reg.#031980)
GMP status The firm M/s Stallion Pharmaceuticals was granted GMP
certificate based on inspection conducted on 22-11-2018.
The firm M/s English Pharmaceutical Industries was
granted GMP certificate based on inspection conducted on
16-01-2018.
Remarks of the Evaluator XIV.  M/s English Pharmaceutical Industries have Dry powder
Injectable (Cephalosporin) section.
 Copy of contract manufacturing agreement is provided
by the firm.
 The applicant firm i.e. M/s Stallion Pharmaceuticals have
4 approved sections and no product registered on contract

manufacturing.
 The firm had initially applied on Form-5 on 25-01-2019.
Later the firm applied on CTD to avail out of queue
priority. Now the firm has requested that their normal
routine queue on Form-5 has been attained since the
initial application was received on 25-01-2019, therefore
consider our application on Form-5.
Multan Road, Lahore
Brand Name +Dosage Form + Strength STAZON 500mg INJECTION IM
Ceftriaxone as sodium……………..500mg
Type of Form Form-5
Me-too status Rezone 500mg Injection IV by M/s Well Care
Pharmaceuticals, Islamabad. (Reg.#031982)
16-01-2018.
by the firm.
manufacturing.
Multan Road, Lahore
Brand Name +Dosage Form + Strength STAZON 250mg INJECTION IM
Ceftriaxone as sodium……………..250mg
Type of Form Form-5
Me-too status Rezone 250mg Injection IV by M/s Well Care
Pharmaceuticals, Islamabad.
16-01-2018.
by the firm.
manufacturing.
Multan Road, Lahore
Brand Name +Dosage Form + Strength STACOLMI 1MIU INJECTION
Colistimethate sodium……………..1MIU
Type of Form Form-5
Finished product Specification The firm has claimed USP specifications
Approval status of product in Reference Promixin, 1 million International Units (IU), Powder for
Regulatory Authorities. Solution for Infusion, which is approximately equivalent
to 80 mg of colistimethate sodium by M/s Zambon S.p.A.,
MHRA Approved.
Me-too status Colistat powder for Injection 1MIU by M/s Medisure Lab
(Reg#076160)
16-01-2018.
Injectable (General) section.
by the firm.
manufacturing.
Multan Road, Lahore
Brand Name +Dosage Form + Strength S-D3 INJECTION
Cholecalciferol (Vitamin D3)……….5mg
Pharmacological Group Vitamin D
Type of Form Form-5
Finished product Specification The firm has claimed EP specifications
Approval status of product in Reference Vitamin D3 200,000 IU / 1 ml IM solution for injection
Regulatory Authorities. of (ANSM France approved)
16-01-2018.
Remarks of the Evaluator XIV.  M/s English Pharmaceutical Industries has provided
Liquid Injection Ampoule & vial (SVP) section.
by the firm.
manufacturing.
Multan Road, Lahore
Brand Name +Dosage Form + Strength STAXIN 400mg CAPSULE
Cefixime as trihydrate……….400mg
Type of Form Form-5
Approval status of product in Reference SUPRAX® (cefixime) capsules, for oral use by Lupin
Regulatory Authorities. Ltd for Lupin Pharma. Approved by US-FDA
Me-too status Nowcef 400mg Capsule by M/s Nawan Lab. Karachi.
Reg. No. 82219

16-01-2018.
Remarks of the Evaluator XIV.  M/s English Pharmaceutical Industries has provided
Capsule (Cephalosporin) section.
by the firm.
manufacturing.
 The product is available in JP.
Decision: Approved with JP specifications.
Multan Road, Lahore
Brand Name +Dosage Form + Strength STAXIN 200mg/5ml SUSPENSION
Cefixime as trihydrate……….200mg
Type of Form Form-5
Finished product Specification USP specifications
Me-too status Fasxime 200mg/5ml Suspension of M/s Fassgen
(Reg#053527)
16-01-2018.
Remarks of the Evaluator XIV.  M/s English Pharmaceutical Industries has provided Oral
Dry powder suspension section.
by the firm.
manufacturing.
 The product is available in JP.
Decision: Approved.
Multan Road, Lahore
Brand Name +Dosage Form + Strength STAFER INJECTION 100mg/5ml
Iron Sucrose complex eq. to elemental iron……….100mg
Pharmacological Group Antianaemic
Type of Form Form-5
Approval status of product in Reference Venofer of Luitpold (USFDA)
Me-too status Axifer of Nova Med
16-01-2018.
Remarks of the Evaluator .XIV
 M/s English Pharmaceutical Industries has provided
Liquid Injection Ampoule & vial (SVP) section.
by the firm.
manufacturing.
Decision: Approved.
1716. Name and address of manufacturer / M/s Radiant Pharma Pvt Ltd., 43-E, Sundar Industrial
Brand Name +Dosage Form + Strength Apocine Dry Suspension 100mg/5ml
Azithromycin as dihydrate………….100mg
Diary No. Date of R& I & fee 10949, dated 15-05-2020, 20,000/- dated 15-05-2020
Type of Form Form-5
Approval status of product in Reference USFDA Approved.
Me-too status Azitma 100mg/5ml dry suspension Tablet of M/s Sami
Karachi. (Reg.# 074901)
GMP status GMP certificate was granted based on the basis of
inspection conducted on 31/07/2018.
Remarks of the Evaluator XIV.
Decision: Approved.
1717. Name and address of manufacturer / M/s Standpharm Pakistan (Pvt.) Ltd. 20-Km Ferozpur
Brand Name +Dosage Form + Strength Epimate 50mg Tablet
Topiramate…………….50mg
Diary No. Date of R& I & fee 26381, 28-12-2017, 20,000/- 28-12-2017
Type of Form Form-5
Approval status of product in Reference Topiramate Teva 50mg tablets MHRA Approved
Me-too status Neutop 50mg tablets by M/s Nabiqasim Industries
(Reg#076388)
GMP status GMP inspection dated 19-10-2017 shows satisfactory level
of compliance.
Remarks of the Evaluator XIV. Upon query, the firm has replied that there was a
typographic error at one place and correct dosage form is
tablet instead of capsule.
Decision: Approved.
1718. Name and address of manufacturer / M/s Trigon Pharmaceuticals (Pvt.) Ltd, 8th Km Thokar
Brand Name +Dosage Form + Strength Tcosmid 10mg Injection
Lacosamide…………….10mg
Diary No. Date of R& I & fee 26646, 29-12-2017, 20,000/- 29-12-2017
Type of Form Form-5
Pack size & Demanded Price 1 × 20ml; Rs. 364.71/- per pack
Approval status of product in Reference Lacosamide G.L. Pharma GmbH 10 mg/ml solution for
Regulatory Authorities. infusion (MHRA Approved)
Me-too status Lacosbar 200mg/20ml Injection by Barrett Hodgson
GMP status Last inspection report dated 25/03/2019, satisfactory level
of GMP compliance.
XIV
Remarks of the Evaluator . The firm has provided Liquid injectable (vial & Ampoule)
section.
b. Deferred cases
1719. Name and address of manufacturer / M/s Searle IV Solutions Pvt Ltd., 1.5 km, Manga
Brand Name +Dosage Form + Strength Macovir Tablet 200/50mg
Composition Each Film coated tablet contains:
Lopinavir….…200mg
Ritonavir.………50mg
Diary No. Date of R& I & fee Dy.No. 8771 dated 23/04/2020,Rs. 20,000/- 23-04-
2020
Type of Form Form-5
Approval status of product in Reference Kaletra (200mg/50mg & 100mg/25mg) Film coated
Regulatory Authorities. tablet by M/s Abbvie, USFDA Approved.
Me-too status Lopinavir/Ritonavir Tablets 200mg/50mg By M/S
Scitech Health (Private) LIMITED (Reg No. 62250)
GMP status The firm has been granted GMP Certificate based on
inspection issued on 15-03-2018.
Previous decision(s) Deferred for submission of evidence of approval of
applied formulation as “uncoated tablets” in reference
the Registration Board in its 275th meeting or else the
formulation may be revised in accordance with reference
product along with submission of requisite fee (M-295).
Evaluation by PEC The firm has submitted revised Form-5 with film coating
composition as per reference formulation.
Decision: Deferred for submission of fee for revision of formulation.
1720. Name and address of manufacturer / M/s Elite Pharma (Pvt.) Ltd, 9.5KM., Sheikhupura
Applicant Road, P.D.H. Street, Lahore.
Brand Name +Dosage Form + Strength Lincomin Injection
Lincomycin as Hydrochloride……………...600mg
Diary No. Date of R& I & fee 3697 dated 19-03-2011, Rs. 8000/-, 20-11-2013,
12000/- (photocopy attached)
Pharmacological Group Lincosamide
Type of Form Form-5
Finished product Specification BP specification
Pack size & Demanded Price 1 × 2ml ampoule ; Rs. 40/-
5 × 2ml ampoule ; Rs. 250/-
Approval status of product in Reference Lincomycin Injection 600mg/2ml ampoule (TGA
Regulatory Authorities. approved).
Me-too status Olinc 600mg/2ml vial of M/s Bosch (Reg#025416)
GMP status  GMP inspection dated 16-07-2018 concluded that the
panel of inspectors is of the opinion that the firm was
maintaining satisfactory level of GMP compliance as
per Drugs Act, 1976 and rules framed thereunder.
Previous remarks of the Evaluator. 
Previous decision(s) Deferred for provision of followings: (M-256)
 Fee Challan of Rs. 12,000.
 Clarification for assay limit of stated amount is not as
per BP in some pages.
 Manufacturing Method.
 Copy of official monograph.
 Commitment as per 251st meeting.
 Last inspection report.
 Proof of FTIR and Thin layer chromatography.
 Gas chromatography along with flame ionization
detector required as per analysis method provided by
the firm.
Registration Board referred the case to QA & LT
Division for updated GMP status of the firm (M-293).
Evaluation by PEC  The firm has claimed BP specifications.
 The firm has referred to inspection report dated 11-02-
2015 which confirm presence of FTIR, TOC analyzer
and Liquid particle counter.
 GMP inspection dated 16-07-2018 concluded that the
panel of inspectors is of the opinion that the firm was
maintaining satisfactory level of GMP compliance as
per Drugs Act, 1976 and rules framed thereunder.
 The firm has submitted Form-5 with correct salt form
alongwith submission of fee challan of Rs. 5000/-
(Deposit slip # 1932735) dated 25-09-2019.
 QA Division vide letter No.F.4-34/98-QA (Vol-I)
informed that the panel was of the opinion that the firm
may be allowed to resume production in Liquid

Injectable Ampoule and Semi Solid (Cream/ Ointment)
Sections only.
Decision: Approved.
1721. Name and address of manufacturer / M/s Honig Pharmaceuticals Laboratories. 14-km,
Applicant Adyala Road, Rawalpindi
Brand Name +Dosage Form + Strength Procyl Tablets
Piroxicam Beta Cyclodextrin eq. to
piroxicam.......20mg
Diary No. Date of R& I & fee Dy.No 4172, 02-02-2018, Rs. 20,000/-, 02-02-2018
Type of Form Form-5
Finished product Specification In-house specifications
Approval status of product in Reference BREXIN 20 mg scored tablet by Pierre Fabre
Regulatory Authorities. Medicament (ANSM Approved)
Me-too status Brexin Tablets 20mg by Chiesi (Reg#10637)
GMP status Inspection report 21-12-2017 The panel unanimously
recommended for the renewal of DML.
Previous remarks of the Evaluator. The label claim is not as per Reference product.
Previous decision(s) Deferred for revision of formulation and label claim as
per the reference regulatory authority approved
reference product (M-288).
Evaluation by PEC The firm has revised label claim as per reference
formulation alongwith fee challan of Rs. 5000/- (deposit
slip # 2049365) dated 18-08-2020.
1722. Name and address of manufacturer / M/s Saibins Pharmaceuticals, Plot 316, Industrial
Applicant Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Azitabin 500mg capsules
Azithromycin (as dihydrate)………..500mg
Diary No. Date of R& I & fee Dy. No.3813; 08-06-2015; Rs.20,000/- (08-06-2015)
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s; As per SRO
Approval status of product in Reference Not confirmed
Me-too status Zygrel 500mg capsules of M/s Searle Pakistan Pvt. Ltd.
GMP status Last inspection report dated 02-01-2017 confirms good
compliance to GMP.
Previous remarks of the Evaluator. Shortcomings
referencel regulatory authorities/agencies
Product specific outline of method of manufacturing
(method of manufacturing for Tiotropium bromide
capsules is provided instead of azithromycin capsules).
Previous decision(s) Deferred for following: (M-274)
regulatory authorities/agencies.
Product specific outline of method of manufacturing.
the Registration Board in its 275th meeting (M-291).

Evaluation by PEC The firm has revised dosage form from capsule to tablet
dosage form due to non-availability of capsule in RRA.
Each film coated tablet contains:
Azithromycin as dihydrate……………500mg
Fee challan of PKR 5000/- (deposit slip#1996362) dated
10-06-2020 has been submitted.
Decision: Deferred for submission of differential fee of Rs. 15,000/- for revision of dosage form
and also confirmation for non-registration of new formulation.
1723. Name and address of manufacturer / M/s Linta Pharmaceuticals Pvt Ltd. Plot No. 03, Street
Applicant No S-5, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Fude Tablets
Sodium Fusidate……………250 mg
Diary No. Date of R& I & fee 976 dated 16-04-2015, Rs.20,000/-
Type of Form Form-5
Finished product Specification BP Specification
Pack size & Demanded Price As per SRO/ 2x10’s
Approval status of product in Reference Fucidin 250mg Tablets of MHRA approved
Me-too status Pandate 250mg Tablets of M/s Panacea Pharma
GMP status 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 an acceptable level
of GMP standard.
Previous decision(s) Deferred for confirmation of installation and operational
qualification of Potentiometer by the area FID (M-249).
Evaluation by PEC The firm has submitted copy of purchase invoice for
potentiometer.
Decision: Deferred for confirmation of installation and operational qualification of
Potentiometer.
1724. Name and address of manufacturer / M/s. Lisko Pakistan, L-10-D, Block No 21, Shaheed
Applicant Rashid Minhas Road, FB Industrial Area, Karachi
Brand Name +Dosage Form + Strength Fluco Tablet 150mg
Fluconazole…………150mg
Diary No. Date of R& I & fee 676, 25-04-2016, Rs. 20,000/- (25-04-2016)
Pharmacological Group Anti-fungal
Type of Form Form-5
Approval status of product in Reference Diflucan (50mg, 150mg) hard capsules by M/s Pfizer
Regulatory Authorities. Limited, MHRA Approved.
Me-too status Diflucan 150mg Cap by M/s Pfizer, Reg. No. 11828
GMP status The firm
Previous remarks of the Evaluator. The application(s) was evaluated and it has been found
that it is incomplete in respect of following
deficiencies/shortcomings:
1. Composition and manufacturing outline not
provided.
2. Undertaking of Form 5 not signed.
3. Specify the dosage form whether film coated or
uncoated tablets.
The firm has replied the deficiencies and changed the
dosage form from Tablet to Capsule.

Each Capsule contains:
Fluconazole………….150mg
Previous decision(s) Deferred for the submission of fresh fee for revised
dosage form (M-274).
Evaluation by PEC The firm has submitted copy of fee challan of Rs.
20,000/- (deposit slip # 0545433) dated 20-12-2017 for
revision of dosage form.
Decision: Approved with following label claim:
Each capsule contains:
Fluconazole………………150mg
1725. Name and address of manufacturer / M/s. Shaigan Pharmaceuticals,14 Km,Adyala Road,
Applicant Post Office Dahgal, Rawalpindi
Brand Name +Dosage Form + Strength Acromax Ointment 0.1%
Composition Each gram of ointment contains: -
Tacrolimus as monohydrate……..1mg
Diary No. Date of R& I & fee Dy. No.1410, Dated 31-10-14,Rs. 20,000
Pharmacological Group Immunomodulator/Macrolide
Type of Form Form 5
Finished product Specification As per Innovator Specs.
Pack size & Demanded Price Rs. 950/30g tube, Rs. 800/10g tube, Rs. 300/5g tube,
Polycoated collapsible tube
Approval status of product in Reference Protopic 0.1% ointment by Leo Laboratories Limited
Regulatory Authorities. (MHRA Approved)
Me-too status Eczemas Ointment of Brookes Pharmaceuticals
GMP status Panel inspection dated 25-09-2019 recommended the
renewal of DML.
Previous decision(s) Deferred for the decision regarding requirement of
manufacturing facility for tacrolimus (M-269).
Evaluation by PEC Registration Board decided to grant registration of these
products in general manufacturing areas with condition
that manufacturer shall provide safety and protective
measures for workers and personnel which remain in
direct contact or are involved in close handling of these
drugs.
Decision: Registration Board decided to approve registration of applied product in general
manufacturing area with condition that manufacturer shall provide safety and protective
measures for workers and personnel which remain in direct contact or are involved in close
handling of these drugs.
Brand Name +Dosage Form + Strength Acromax Ointment 0.03%
Composition Each gram of ointment contains:-
Tacrolimus as monohydrate……..0.3mg
Diary No. Date of R& I & fee Dy. No.1409, Dated 31-10-14, Rs. 20,000
Pharmacological Group Immunomodulator/Macrolide
Type of Form Form 5
Finished product Specification As per Innovator Specs.
Pack size & Demanded Price Rs. 950/30g tube, Rs. 800/10g tube, Rs. 300/5g tube,
Polycoated collapsible tube
Approval status of product in Reference Protopic 0.03% ointment by M/s LEO Pharma A/S,
Regulatory Authorities. MHRA Approved.
Me-too status Imunol Ointment 0.03% by M/s Saffron Pharma (Pvt)
Ltd, (Reg # 046443)
renewal of DML.
Previous decision(s) Deferred for the decision regarding requirement of
manufacturing facility for tacrolimus (M-269).
Evaluation by PEC Registration Board decided to grant registration of these
products in general manufacturing areas with condition
that manufacturer shall provide safety and protective
measures for workers and personnel which remain in
direct contact or are involved in close handling of these
drugs.
Decision: Registration Board decided to approve registration of applied product in general
manufacturing area with condition that manufacturer shall provide safety and protective
measures for workers and personnel which remain in direct contact or are involved in close
handling of these drugs.
Brand Name +Dosage Form + Strength Endocor 100 injection
Composition Each ampoule / 1ml contains
Octreotide as acetate………..100mcg
Diary No. Date of R& I & fee Dy. 764; 02-09-2016; Rs.20,000/- (01-09-2016)
Pharmacological Group Somatostatin Analogue
Type of Form Form-5
Finished product Specification Manufacturer specification
Pack size & Demanded Price 1x5 ampoule
Rs.2533.90
Approval status of product in Reference Sandostatin, (USFDA Approved)
Me-too status Sandostatin Injection by M/s Novartis Pharma.
(Reg#013472)
renewal of DML.
Previous decision(s) Registration Board referred to Biological Drugs
Division, being biological drug (M-263).
Subsequently registration referred the formulation of
Octreotide acetate injection to the PE & R Division for
further processing (M-277).
Registration Board deferred the case for following
observations/clarifications: (M-282).
Manufacturing requirement with respect to atmospheric
conditions i.e. temperature, for applied formulation.
Source of API whether of synthetic or biological origin.
Evaluation by PEC Deputy Director Biological Drugs, has forwarded this
application vide letter No. F.3-158/2017 AD (BE&R)
dated 16-02-2018, with request to process the case as per
above decision of Registration Board.
The firm has submitted that the API Octreotide Acetate
is synthetic by its origin and processes and is not a
biological product. Accordingly, COA of API
manufacturer M/s Bachem Americas, Inc. 3132 Kashiwa
Street Torranc, CA 90505, USA has been submitted
which indicates API as of synthetic origin.
Decision: Registration Board deferred for further deliberation to review innovator’s product
status whether biological or synthetic origin.
Brand Name +Dosage Form + Strength Endocor 50 injection
Composition Each ampoule / 1ml contains
Octreotide as acetate …..50mcg

Diary No. Date of R& I & fee Dy. 757 02-09-2016; Rs.20,000/- (01-09-2016)
Pharmacological Group Somatostatin Analogue
Type of Form Form-5
Finished product Specification Manufacturer specification
Pack size & Demanded Price 1x5 ampoule
Rs.1333.90
Approval status of product in Reference Sandostatin, (USFDA Approved)
Me-too status Octreotide 50mcg injection by m/s m/s. Revive health
care, (Reg#082066)
renewal of DML.
Previous decision(s) Registration Board referred to Biological Drugs
Division, being biological drug (M-263).
Subsequently registration referred the formulation of
Octreotide acetate injection to the PE & R Division for
further processing (M-277).
Registration Board deferred the case for following
observations/clarifications: (M-282).
Manufacturing requirement with respect to atmospheric
conditions i.e. temperature, for applied formulation.
Source of API whether of synthetic or biological origin.
Evaluation by PEC Deputy Director Biological Drugs, has forwarded this
application vide letter No. F.3-158/2017 AD (BE&R)
dated 16-02-2018, with request to process the case as per
above decision of Registration Board.
The firm has submitted that the API Octreotide Acetate
is synthetic by its origin and processs and is not a
biological product. Accordingly, COA of API
manufacturer M/s Bachem Americas, Inc. 3132 Kashiwa
Street Torranc, CA 90505, USA has been submitted
which indicates API as of synthetic origin.
Decision: Registration Board deferred for further deliberation to review innovator’s product
status whether biological or synthetic origin.
Brand Name +Dosage Form + Strength Prolone Injection
Methylprednisolone acetate …….40mg
Diary No. Date of R& I & fee Dy.No.763 dated 02-09-2016, Rs.20,000/-
Pharmacological Group Glucocorticoid
Type of Form Form-5
Pack size & Demanded Price 1x2ml, Rs.224.62/-
Approval status of product in Reference Depo-medrol by Pfizer Pharma (EU)/USA,
Me-too status Depo-medrol by Pfizer Pharma,
renewal of DML.
Previous decision(s) Registration Board deferred products and advised to get
approval from Licensing Division for lyophilized
injection vials (steroids) and liquid injection ampoules
(steroids) respectively for further processing by
Registration Board (M-273).
Evaluation by PEC The firm has submitted that the said product can be be

manufactured in the approved Liquid Injection Hormone
section with justification that Methyprednisolone on the
basis of pharmacological classification is a synthetic
steroid which falls under the sub-heading of hormones.
Decision: Deferred for confirmation of required manufacturing facility i.e., Liquid Injectable
Steroid section for applied formulation.
Brand Name +Dosage Form + Strength Bpride Tablets
Cinitapride as Hydrogen Tartrate………1mg
Diary No. Date of R& I & fee Dy.No.1959 dated 27-03-2015, Rs.8000/- (Photocopy
attached) Rs.12,000/- 25-03-2015
Pharmacological Group Gastroprokinetic Agent
Type of Form Form-5
Finished product Specification ----
Pack size & Demanded Price 10’s, Rs. 170
Approval status of product in Reference Cidine 1 mg uncoated tablet by Almirall, SA (Spain
Me-too status Cidine Tablets 1mg by M/s Highnoon Lab
GMP status 17-08-2016 recommended for the grant of additional
sections
Previous decision(s) Deferred for the submission of GMP inspection report
conducted within the last 01 year (M-277).
Evaluation by PEC Panel inspection dated 25-09-2019 recommended the
renewal of DML.
Brand Name +Dosage Form + Strength Renon-25 Tablets
Eplerenone ………….. 25mg
Diary No. Date of R& I & fee Dy No. 550, dated 4-06-2014, Rs.20,000
Pharmacological Group Aldosterone Blocker
Type of Form Form-5
Finished product Specification Innovator Specs
Pack size & Demanded Price 1x14’s; Rs. 478/pack
Approval status of product in Reference Inspra by GD Searle LLC (USFDA Approved)
Me-too status Urenon 25mg Tablet by Tabros.
renewal of DML.
Previous decision(s) Registration Board deferred the case for the
confirmation of steroidal tablet section (M-269).
Evaluation by PEC The firm was granted additional section as “Tablet
hormone section” vide panel inspection dated 17-08-
2016.
Decision: Deferred for confirmation of approved manufacturing facility for steroidal tablet
section.
Brand Name +Dosage Form + Strength Renon-50 Tablets
Eplerenone ………….. 50mg
Diary No. Date of R& I & fee Dy No. 386, dated 04-06-2014, Rs.20,000
Pharmacological Group Aldosterone Blocker
Type of Form Form-5
Finished product Specification Innovator Specs
Pack size & Demanded Price 1x14’s; Rs. 832/pack
Approval status of product in Reference Inspra by GD Searle LLC (USFDA Approved)
Me-too status Urenon 50mg Tablet by Tabros.
renewal of DML.
Previous decision(s) Registration Board deferred the case for the
confirmation of steroidal tablet section (M-269).
Evaluation by PEC The firm was granted additional section as “Tablet
hormone section” vide panel inspection dated 17-08-
2016.
Decision: Deferred for confirmation of approved manufacturing facility for steroidal tablet
section.
1733. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, D-
Applicant 122, S.I.T.E, Karachi
Brand Name +Dosage Form + Strength Zolot-S 75/75mg Tablet
Clopidogrel as Hydrogen Phosphate………….75mg
Aspirin……….……………………………….75mg
Diary No. Date of R& I & fee Dy. No: 1065 dated 30.04.2011, Rs.8,000/-,
26.07.2013, Rs.12,000/-
Pharmacological Group Antiplatelet
Type of Form Form-5
Pack size & Demanded Price Rs. 14.50/Tablet; 10’s
Approval status of product in Reference COPLAVIX 75 mg/75 mg clopidogrel (as hydrogen
Regulatory Authorities. sulfate)/aspirin tablets blister pack by M/s anofi-Aventis
Australia Pty Ltd (TGA Approved)
Me-too status CoPlavix Tablets 75/75mg by M/s Sanofi (Reg#075978)
GMP status GMP inspection conducted on 01-10-2018 concluded
that the firm is found to be complying at a good level of
GMP compliance.
Previous decision(s) Deferred for verification of bi-layered compression
machine by area FID (M-258).
Registration board deferred the case for further
deliberation since the product approved by reference
regulatory authorities is film coated tablet prepared by
mixing granules of clopidogrel (prepared by wet
granulation) and aspirin (prepared by dry granulation)
(M-286).
Evaluation by PEC Area FID in his inspection report dated 01-10-2018
confirmed that the firm had double-pressing
automatically revolving piece-pressing machine (Rotary
tablet press ZP420-31D).
The firm has submitted that the applied formulation is in
line with reference product which is film coated in TGA
i.e., APO-CLOPIDOGREL 75/75. Moreover,
verification of bi-layered machine has been confirmed
from Area FID inspection report.
Decision: Deferred for confirmation of method of manufacture of applied formulation in the light
of innovator product.

1734. Name and address of manufacturer / M/s Opal Laboratories (Pvt.) Limited, LC-41, L.I.T.E.,
Applicant Landhi, Karachi
Brand Name +Dosage Form + Strength GALVO TABLET 50mg
Vildagliptin…………..….50mg
Type of Form Form-5
Pack size & Demanded Price 2 × 14’s; As per DRAP policy
Approval status of product in Reference Galvus 50mg tablet of M/s Novartis Pharmaceuticals,
Regulatory Authorities. UK Ltd (MHRA Approved)
Me-too status Galvus 50mg tablet of M/s Novartis Pharmaceuticals,
Karachi (Reg # 059038)
GMP status The firm has submitted copy of inspection conducted on
08-02-2018 in which the firm was considered to be
operating at fair level of compliance.
Previous remarks of the Evaluator.  Reference formulation approved in MHRA is uncoated
tablet while applied formulation is film coated tablet.
Revision of Form-5 and master formulation with
requisite fee is required.
Previous decision(s) Deferred for revision of formulation as per reference /
innovator product (M-290).
Evaluation by PEC The firm has submitted revised master formulation with
following label claim:
Each tablet contains:
Vildagliptin…………..50mg
Fee challan of Rs. 5000/- (Deposit slip # 1926745) dated
24 -08-2020 has been submitted.
Decision: Approved with innovator’s specifications and with following label claim:
Vildagliptin………….50mg
1735. Name and address of manufacturer / M/s Alfalah Pharma Pvt Ltd.,
Applicant 12 km, Sheikhupura Road, Lahore, Pakistan
Brand Name +Dosage Form + Strength Milton 500mg Tablet
Azithromycin as Dihydrate…..............500mg
Diary No. Date of R& I & fee 12248 dated 02/06/2020 Rs. 20,000/- dated 02-06-2020
Type of Form Form-5
Me-too status Azic 500mg Tablet by M/s Nabi Qasim (Reg # 055584)
GMP status Panel inspection dated 26-06-2019 & 16-09-2019
recommnended renewal of DML and grant of additional
section i.e., Capsule General
Previous decision(s) Deferred for submission of application on approved
format of Form-5 and GMP status (M-295).
Evaluation by PEC The firm has submitted application on Form-5 and
updated GMP status.
Decision: Approved.
Brand Name +Dosage Form + Strength Azolike 250mg Capsule
Type of Form Form-5
Finished product Specification USP Specifications
Me-too status Zidor Capsule 250mg of M/s Winthrox Karachi. (Reg.#
074943)
Previous decision(s) Deferred for submission of application on approved
format of Form-5 and GMP status (M-295).
updated GMP status.
Decision: Approved.
Brand Name +Dosage Form + Strength Azolike 500mg Capsule
Type of Form Form-5
Me-too status Azithromycin 500mg Capsules Uni pharma (Pvt) Ltd.,
Lahore. 071422
Previous decision(s) Deferred for evidence of approval of applied
formulation in reference regulatory authorities adopted
by Registration Board in 275th meeting (M-295).
updated GMP status.
authorities adopted by Registration Board in 278th meeting.
1738. Name and address of manufacturer / M/s Albert Pharmaceuticals (Pvt.) Ltd., Plot # 127,
Applicant Sundar Industrial Estate, Raiwind, Lahore
Brand Name +Dosage Form + Strength DELOAD Dry Suspension
Composition Each 5ml (when reconstituted) contains:
Nitazoxanide……………100mg
Pharmacological Group Antiprotozoal
Type of Form Form-5
Pack size & Demanded Price 30ml & 60ml; As per SRO
Approval status of product in Reference Alinia by Romark (USFDA Approved)
Me-too status Diatazox 100mg/5ml Dry Suspension of M/s S.J & G
GMP status GMP status could not be verified.
Previous remarks of the Evaluator. The firm has provided oral dry powder suspension
(General) section.
Previous decision(s) Registration Board referred the case to QA & LT
Division for updated GMP status of the firm (M-290).
Evaluation by PEC The firm has submitted copy of GMP certificate granted
based on inspection dated 30-05-2019.
1739. Name and address of manufacturer / M/s Albert Pharmaceutical (Pvt)Ltd. Plot # 127 Sundar
Applicant Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Cipralt Dry Suspension 250mg/5ml
Ciprofloxacin (as hydrochloride monohydrate)
…250mg
Diary No. Date of R& I & fee DiaryNo:8420; 11/07/2017; Rs:20,000/-
Type of Form Form-5
Pack size & Demanded Price 60 ml/As per SRO
Approval status of product in Reference Approved in USFDA
Regulatory Authorities. Ciproxin® 250 mg/5 ml granules and solvent for oral
Suspension by M/s Bayer Healthcare, (MHRA
approved)
Me-too status Novidat dry powder suspension 250mg/5ml by Sami
Pharma
GMP status New DML
Previous remarks of the Evaluator. In reference agencies it is approved as ciprofloxacin
“granules for oral suspension while the firm has applied
for powder for oral suspension.
Solvent Soya lecithin, Medium chain triglycerides,
Strawberry flavor, Sucrose, Purified water.
Previous decision(s) Deferred for the following reasons (M-274):
Clarification of dosage form as the applicant has applied
for “powder for oral suspension” which is different
from the product approved in reference agenciesi.e.
“granules for oral suspension”
Clarification of type of solvent supplied by manufacturer
for reconstitution of applied formulation, as solvent
approved in reference agencies is an oil based solvent
consisting of following ingredients that are “Soya
lecithin, Medium chain triglycerides, Strawberry flavor,
Sucrose, Purified water”.
Evaluation by PEC The firm has revised label claim with ciprofloxacin base
as follows alongwith submission of fee:
Each 5ml suspension (when reconstituted) contains:
Ciprofloxacin as taste masked granules.………250mg
The firm has clarified dosage form as granules for oral
suspension.
Source of granules: M/s Vision Pharmaceuticals
The firm has submitted copy of GMP certificate granted
Decision: Deferred for submission of fee for revision of formulation as per reference.
1740. Name and address of manufacturer / M/s Albert Pharmaceutical (Pvt) Ltd. Plot # 127
Applicant Sundar Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Cipralt Dry Suspension 125mg/5ml

Ciprofloxacin (as hydrochloride monohydrate)
……….125mg
Diary No. Date of R& I & fee Diary No:8421; 11/07/2017; Rs:20,000/-
Type of Form Form-5
Pack size & Demanded Price 60 ml/As per SRO
Approval status of product in Reference Cipro 125mg/5ml of Bayer Healthcare,(USFDA)
Me-too status Ciprin 125mg/5ml suspension of M/s Werrick
pharmaceuticals
GMP status New DML
Previous decision(s) Deferred for deliberation in light of 269th Registration
Board meeting and GMP (M-274).
Evaluation by PEC The firm has revised label claim with ciprofloxacin base
as follows alongwith submission of fee:
Each 5ml suspension (when reconstituted) contains:
Ciprofloxacin as taste masked granules………125mg
The firm has clarified dosage form as granules for oral
suspension.
Decision: Deferred for submission of fee for revision of formulation as per reference.
1741. Name and address of manufacturer / M/s Albert Pharmaceutical (Pvt) Ltd. Plot # 127
Applicant Sundar Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Klaret Dry Suspension125mg/5ml
Clarithromycin (as granules)………125mg
Diary No. Date of R& I & fee Diary No: 8423; 11/07/2017; Rs:20,000/-
Pharmacological Group Antibiotic (Macrolide)
Type of Form Form-5
Pack size & Demanded Price 60ml/As perSRO
Approval status of product in Reference Biaxin granules for oral suspension 125mg/5mlbyM/s
Regulatory Authorities. Abbvie, (USFDA Approved).
Me-too status Klarim Dry Suspension 125mg/5ml of Amrose
Pharmaceuticals
GMP status New DML
Previous remarks of the Evaluator. Firm has applied for powder for oral suspension while in
reference agencies it is approved as granules for oral
suspension.
Previous decision(s) Deferred for clarification of dosage form as the applicant
has applied for “powder for oral suspension” which is
different from the product approved in reference
agenciesi.e. “granules for oral suspension” (M-274).
Evaluation by PEC The firm has clarified dosage form as granules for oral
suspension.
Decision: Approved.
1742. Name and address of manufacturer / M/s Zephyr Pharmatec (Pvt) Limited, Karachi
Applicant
Brand Name +Dosage Form + Strength L SULPRID Tablet 25mg
Levosulpiride…………..25mg
Diary No. Date of R& I & fee Dy. No: 2290-R-II dated 31-12-10, 8000/- dated 31-12-
10, 12000 dated 01-08-13
Pharmacological Group Benzamide antipsychotic
Type of Form Form-5
Pack size & Demanded Price As per PRC/ 2x10’s
Approval status of product in Reference Levopraid 25 mg tablet of AIFA Italy
Me-too status Scipride tablet M/s Getz Pharma
GMP status GMP inspection dated 25-09-2019 overall GMP
compliance is rated as GOOD.
Previous decision(s) Deferred for review of formulation (M-248).
Evaluation by PEC Approval status of applied formulation has been
confirmed in AIFA Italy.
1743. Name and address of manufacturer / M/s Zephyr Pharmatec (Pvt) Limited, Karachi
Applicant
Brand Name +Dosage Form + Strength L SULPRID Tablet 50mg
Levosulpiride…………..50mg
Diary No. Date of R& I & fee Dy. No: 2289-R-II dated 31-12-10, 8000/- dated 31-12-
10, 12000 dated 01-08-13
Pharmacological Group Benzamide antipsychotic
Type of Form Form-5
Pack size & Demanded Price As per PRC/ 2x10’s
Approval status of product in Reference Levopraid 50 mg tablet of AIFA Italy
Me-too status Scipride tablet M/s Getz Pharma
GMP status GMP inspection dated 25-09-2019 overall GMP
compliance is rated as GOOD.
Evaluation by PEC Approval status of applied formulation has been
confirmed in AIFA Italy.
1744. Name and address of manufacturer / Applicant: M/s A’raf (Pvt) Ltd, 23-Km, Raiwind Road,
Applicant Lahore
Manufacturer: M/s. English Pharmaceutical Industries,
Link Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore
Brand Name +Dosage Form + Strength Opizole 40mg Injection
Composition Each vial contains:-
Omeprazole Sodium (Lyophilized) eq. to
Omeprazole………….40mg
Diary No. Date of R& I & fee Dy No. 3061, 14-05-2013, Rs.50000/-, 14-05-2013
Type of Form Form-5
Approval status of product in Reference Omeprazole IV 40mg Injection of sandoz (TGA)
Me-too status Risek 40mg injection by Getz Pharma
GMP status GMP certificate of M/s English Pharmaceuticals issued
on the basis of inspection conducted on 26-01-2018.
Previous decision(s) The Board deferred the case for clarification regarding
name of the firm (M-265).
Deferred for submission of GMP status of “M/s A’raf
(Pvt) Ltd, 23-Km, Raiwind Road, Lahore (DML
No.00685)” and number of products already approved in
contract manufacturing and details of section approved
by CLB (M-289).
Evaluation by PEC Secretary RB apprised the Board that firm has changed
their name to M/s A’raf Pharmaceuticals Lahore.
The firm has submitted documents of licensing division
dated 11th November, 2013 for change of name of
company to “M/s A’raf (Pvt) Ltd, 23-Km, Raiwind Road,
Lahore (DML No.00685)”.
The firm M/s A’raf (Pvt) Ltd submitted copy of panel
inspection dated 12-06-2020 wherein the panel
concluded that the firm has good compliance to GMP.
M/s A’raf (Pvt) Ltd, Lahore has no products on contract
manufacturing.
The firm M/s English Pharmaceutical Industries, Lahore
has provided Dry powder Injectable (General) section for
the manufacturing of this formulation.
1745. Name and address of manufacturer / Applicant: M/s A’raf (Pvt) Ltd, 23-Km, Raiwind Road,
Applicant Lahore
Manufacturer: M/s. English Pharmaceutical Industries,
Link Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore
Brand Name +Dosage Form + Strength Piprazo 4.50gm Injection
Sterile Piperacillin Sodium eq. to Piperacillin
………….4.0gm
Sterile Tazobactam Sodium eq. to Tazobactam
…………0.50gm
Diary No. Date of R& I & fee Dy No. 3062, 14-05-2013, Rs.50000/-, 14-05-2013
Pharmacological Group Penicillin antibiotic
Type of Form Form-5
Approval status of product in Reference Piperacillin Tazobactum by Sandoz (MHRA Approved)
Me-too status Tazocin 4.5gm by Wyeth Ltd
GMP status GMP certificate of M/s English Pharmaceuticals issued
on the basis of inspection conducted on 26-01-2018.
Previous decision(s) The Board deferred the case for clarification regarding
name of the firm (M-265).
Deferred for submission of GMP status of “M/s A’raf
(Pvt) Ltd, 23-Km, Raiwind Road, Lahore (DML
No.00685)” and number of products already approved in
contract manufacturing and details of section approved
by CLB (M-289).
Evaluation by PEC Secretary RB apprised the Board that firm has changed
their name to M/s A’raf Pharmaceuticals Lahore.
The firm has submitted documents of licensing division
dated 11th November, 2013 for change of name of
company to “M/s A’raf (Pvt) Ltd, 23-Km, Raiwind Road,
Lahore (DML No.00685)”.
th
The firm M/s A’raf (Pvt) Ltd submitted copy of panel
inspection dated 12-06-2020 wherein the panel
concluded that the firm has good compliance to GMP.
M/s A’raf (Pvt) Ltd, Lahore has no products on contract
manufacturing.
The firm has provided Dry Powder Injectable (Penicillin)
section.
1746. Name and address of manufacturer / M/s Gulf Pharmaceuticals, Plot # 49, Street # S-5,
Applicant National industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Telsar-AM Tablet 5/80mg
Amlodipine (as besylate)……………5mg
Telmisartan……………………….…80mg
Diary No. Date of R& I & fee Form-5 Dy.No 5454 dated 14-02-2018 Rs. 20,000/-
Dated 14-02-2018
Pharmacological Group Angiotensin II antagonists and calcium channel blocker
Type of Form Form-5
Pack size & Demanded Price 14’s/ As per SRO
Approval status of product in Reference Telmisartan and amlodipine tablet 5mg/80mg by M/s
Regulatory Authorities. Mylan Pharmaceuticals Inc. (USFDA approved)
Me-too status Telsarta-A 5/80 Tablet by M/s Pharmevo
(Reg#073762)
GMP status Last GMP inspection conducted on 02-2-2018 & 07-2-
2018, and report concludes recommendation for renewal
of DML.
Previous remarks of the Evaluator. In reference regulatory authorities like in EMA and
USFDA the applied drug is multi-layered tablet, firm has
not applied drug as multi layered tablet.
Firm has not submitted evidence of double layer
compression machine.
Previous decision(s) Deferred for the clarification of manufacturing outline as
in reference regulatory authorities the approved drug is
multilayered tablet, while the applied drug is mono
layered tablet and submission of double layer
compression machine (M-288).
Evaluation by PEC The firm has submitted evidence of procurement of
multiple layer compression machine with following
details;
Copy of invoice of multiple layered compression
machine attached.
Copy of delivery challan is attached
Decision: Deferred for submission of Installation Qualification (IQ), Operational Qualification,
Performance Qualification (PQ) Reports of required manufacturing equipment i.e. tablet
bilayered machine.
Dated 14-02-2018
Type of Form Form-5

(Reg#073763)
of DML.
Evaluation by PECXIV The firm has submitted evidence of procurement of
details;
machine attached.
Copy of delivery challan is attached.
bilayered machine.
Dated 14-02-2018
Type of Form Form-5
(Reg#073763)
of DML.

Evaluation by PECXIV The firm has submitted evidence of procurement of
details;
machine attached.
Copy of delivery challan is attached.
bilayered machine.
Brand Name +Dosage Form + Strength Stinough 150mg Capsule
Erdosteine…………………..…150mg
Dated 14-02-2018
Pharmacological Group Mucolytics
Type of Form Form-5
Pack size & Demanded Price 2 × 10’s/ As per SRO
Me-too status Erdozet Capsules 150mg by M/s S.J&G (Reg#073809)
of DML.
Previous remarks of the Evaluator. Approval status of product in Reference Regulatory
Authorities not confirmed.
Previous decision(s) Deferred for evidence of applied formulation/drug
already approved by DRAP (generic/ me-too status)
alongwith registration number, brand name and name of
firm (M-288).
Evaluation by PEC XIV
The firm has submitted me-too reference “Erdos 150mg
Capsule of Platinum Pharmaceuticals (Reg#053047)”.
However, evidence of Approval status of product in
Reference Regulatory Authorities could not be
confirmed.
authorities adopted by Registration board in 275th meeting.
1750. Name and address of manufacturer / M /s Focus & Rulz Pharmaceuticals Pvt Ltd. 44-
Applicant industrial triangle kahuta road Islamabad.
Brand Name +Dosage Form + Strength FAVIRULZ Tablet 200mg
Favipiravir……..……200mg
Diary No. Date of R& I & fee Dy.No. 13274 dated 10/06/2020 Rs. 50,000/- dated 10-
06-2020
Type of Form Form-5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 10’s, 20’s, 30’s, 40’s/ As per DPC
Approval status of product in Reference Avigan 200mg Film coated Tablet by M/s Toyama
Regulatory Authorities. Chemical Co., Ltd Japan (PMDA Approved)
Me-too status N/A
GMP status The firm has been granted GMP certificate based on
Previous decision(s) Deferred for submission of application on Form-5D (M-

295).
Evaluation by PEC The firm has submitted application on Form-5D
alongwith undertaking to perform stability studies
before marketing of the product.
Decision: Approved.
1751. Name and address of manufacturer / M/s Moringa Pharmaceuticals, 35-A Sundar Industrial
Brand Name +Dosage Form + Strength EVAGAN Tablet 200mg
Favipiravir…..……200mg
Diary No. Date of R& I & fee Dy.No. 13133 dated 09/06/2020 Rs. 20,000/- dated 09-
06-2020
Pack size & Demanded Price As per DPC
Approval status of product in Reference Avigan 200mg Film coated Tablet by M/s Toyama
Regulatory Authorities. Chemical Co., Ltd Japan (PMDA Approved)
Me-too status N/A
GMP status The firm is granted GMP certificate based on inspection
conducted on 30-5-2019.
Previous remarks of the Evaluator. Differential fee of Rs. 30,000/- alongwith Form-5D is
required to be
Previous decision(s) Deferred for submission of differential fee of Rs.
30,000/- alongwith application on Form-5D (M-295)
Evaluation by PEC The firm has submitted differential fee of PKR 30,000/-
(deposit slip # 2026070) dated 12-06-2020.
Decision: Approved.
1752. Name and address of manufacturer / "M/s Winlet Pharmaceuticals.
Applicant 30-km, Lahore Sargodha Road, Lahore"
Brand Name +Dosage Form + Strength Valet 50mg Tablet
Composition "Each Film coated tablet Contains:
Voriconazole…50mg"
Type of Form Form-5
Finished product Specification Japanese Pharmacopoeia Specifications
Approval status of product in Reference Approved in MHRA as film coated Tablet
Me-too status Vorinaz 50mg Tablet of Atco Lab. Karachi
GMP status Panel Inspection for grant of DML conducted on 12-10-
2017 & 12-12-2017 decided as follow:
Keeping in view the above improvements made by the
firm the members of the panel are of the opinion to
recommend the grant of DML for the following sections
by the way of formulation:
1. General Tablet Section
2. General Capsule Section
3. Oral Dry Powder Suspension Section (General)
4. Liquid Syrup (General)
Previous remarks of the Evaluator. Please submit either evidence of reference product
approved as uncoated tablet or otherwise convert it to
film coated tablet alongwith submission of requisite fee.
Previous decision(s) Deferred for submission of either evidence of reference
product approved as uncoated tablet or otherwise change
it to film coated tablet alongwith submission of requisite
fee, master formulation & manufacturing method.
Evaluation by PEC The firm has submitted revised Form-5 with Film
coating composition and label claim as per reference
formulation alongwith submission of fee challan of Rs.
5000/- (deposit slip # 2003835) dated 17-08-2020.
Decision: Approved.
Brand Name +Dosage Form + Strength Valet 200mg Tablet
Composition "Each Film coated Tablet Contains:
Voriconazole…200mg"
Type of Form Form-5
Finished product Specification Japanese Pharmacopoeia Specifications
Approval status of product in Reference Approved in MHRA as film coated Tablet
Me-too status Vorinaz 200mg Tablet of Atco Lab. Karachi
3. Oral Dry Powder Suspension Section(General)
4. Liquid Syrup (General)
Previous remarks of the Evaluator. Please submit either evidence of reference product
approved as uncoated tablet or otherwise convert it to
film coated tablet alongwith submission of requisite fee.
Previous decision(s) Deferred for submission of either evidence of reference
product approved as uncoated tablet or otherwise change
it to film coated tablet alongwith submission of requisite
fee, master formulation & manufacturing method.
Evaluation by PEC The firm has submitted revised Form-5 with Film
coating composition and label claim as per reference
formulation alongwith submission of fee challan of Rs.
5000/- (deposit slip # 2003834) dated 17-08-2020.
Decision: Approved.
Brand Name +Dosage Form + Strength Itrazole 100mg Capsule
Composition “Each Capsule Contains:
Itraconazole (as IR pellets)……………100mg"
Type of Form Form-5
Approval status of product in Reference USFDA approved
Me-too status Itrax Capsule 100mg of Ferozsons Labs.

4. Liquid Syrup(General)
Previous remarks of the Evaluator. COA, GMP of pellets manufacturer and stability studies
of three batches of pellets conducted in accordance with
zone IV-A conditions.
Previous decision(s) Deferred for submission of COA, GMP of pellets
manufacturer and stability studies of three batches of
pellets conducted in accordance with zone IV-A
conditions (M-295).
Evaluation by PEC The firm has submitted COA, GMP certificate and
stability study data of pellets from M/s Vision
Pharmaceuticals (Pvt) Ltd., Islamabad.
Brand Name +Dosage Form + Strength Diclowin 75mg Tablet
Composition "Each Enteric Coated Tablet Contains:
Diclofenac sodium…75mg"
Type of Form Form-5
Pack size & Demanded Price 20’s : As per SRO
Approval status of product in Reference Voltaren 75mg delayed release tablet discontinued in
Regulatory Authorities. USFDA not due to safety or efficacy reasons.
Me-too status Fedgesic Tablets 75mg of Fedro Pharmaceutical
Previous remarks of the Evaluator. Evidence of approval of applied formulation as enteric
coated tablet in reference regulatory authorities/agencies
which were declared/approved by the Registration
Previous decision(s) Deferred for evidence of approval of applied
formulation as enteric coated tablet in reference
meeting (M-295).
Evaluation by PEC Approval status of applied formulation is confirmed in
USFDA.
Decision: Approved.
Brand Name +Dosage Form + Strength Albawin 200mg Tablet

Composition "Each Chewable Tablet Contains:
Albendazole………….…200mg"
Type of Form Form-5
Pack size & Demanded Price 2‟s, 10‟s: As per SRO
Approval status of product in Reference Approved in TGA
Me-too status Not verifiable
Previous remarks of the Evaluator. Evidence of applied formulation/drug i.e. Albendazole
200mg chewable tablet already approved by DRAP
(generic / me-too status) alongwith registration number,
Please submit justification for carrying out film
coating of a chewable tablet.
Previous decision(s) Deferred for the following: (M-295)
 Evidence of applied formulation/drug i.e. Albendazole
200mg chewable tablet already approved by DRAP
(generic / me-too status) alongwith registration
Evaluation by PEC The firm has submitted me-too reference of “Albendol
200mg Tablet of M/s Vision Pharma (Reg # 038418)”
which has been verified.
Decision: Approved.
1757. Name and address of manufacturer / “M/s Winlet Pharmaceuticals.
Brand Name +Dosage Form + Strength Loret 5mg/5ml Syrup
Composition “Each 5ml Contains:
Loratadine…………5mg”
Pharmacological Group H1 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 60ml: As per SRO
Approval status of product in Reference Approved in MHRA (as solution)(amber glass bottle)
Me-too status Loradine Syrup 5mg/5ml of Global Pharmaceuticals

Previous decision(s) Deferred for the following:
 Mention type of primary packaging material of applied
formulation.
 Submit clarification regarding physical form of applied
drug product as reference product is approved as
solution while applied formulation is syrup.
Evaluation by PEC The firm has submitted approval status of syrup dosage
form in MHRA as follows:
“LORATADINE 5MG/5ML SYRUP of Galpharm
Healthcare Limited Hugh House Dodworth Business
Park Barnsley South Yorkshire”
Primary packaging material: Amber glass bottle
Decision: Approved.
1758. Name and address of manufacturer / M/s Panacea Pharmaceuticals, Plot no.4, Street no. S-6,
Brand Name +Dosage Form + Strength O-Lanz Plus Capsules 6/25mg
Olanzapine ………….……...............6mg
Fluoxetine hydrochloride eq. to Fluoxetine……25mg
Diary No. Date of R& I & fee Dy. No.2997 ; 19-12-2016; Rs.20,000/- (16-12-2016)
Type of Form Form-5
Pack size & Demanded Price As recommended by PRC
Approval status of product in Reference Symbyax of M/s Eli Lilly & Company (USFDA
Me-too status Co-Depricap of M/s Nabiqasim
GMP status Last GMP inspection was conducted on 08-12-2016
which concludes good level of GMP compliance.
Division to conduct GMP inspection of Firm on priority
(M-279).
Evaluation by PEC QA division vide letter No.F.4-5/2007-QA dated 26-08-
2019 has informed that current GMP status of the firm
shall be considered as compliant.
Decision: Approved.
1759. Name and address of manufacturer / M/s Panacea Pharmaceuticals, Plot no.4, Street no. S-6,
Brand Name +Dosage Form + Strength O-Lanz Plus Capsules 12/25mg
Olanzapine ………….……...............12mg
Fluoxetine hydrochloride eq. to Fluoxetine……25mg
Type of Form Form-5
Approval status of product in Reference Symbyax of M/s Eli Lilly & Company (USFDA
Me-too status Co-Depricap of M/s Nabiqasim
GMP status Last GMP inspection was conducted on 08-12-2016
which concludes good level of GMP compliance.
Division to conduct GMP inspection of Firm on priority
(M-279).
Evaluation by PEC QA division vide letter No.F.4-5/2007-QA dated 26-08-
2019 has informed that current GMP status of the firm
shall be considered as compliant.
Decision: Approved.
1760. Name and address of manufacturer / M/s Sigma Pharma International (Pvt.) Ltd.,Plot # E-50,
Applicant North Western industrial Zone, Bin Qasim, Karachi
Brand Name +Dosage Form + Strength SOMTIME CAPSULE
Tamsulosin Hydrochloride (modified release
pellets)………….0.4mg
Source of pellets: RA Chem pharma, India
Pharmacological Group Alpha1 adrenoceptor Blocker
Type of Form Form-5
Pack size & Demanded Price 1 × 10’s ; As per DRAP policy
1 × 20’s ; As per DRAP policy
1 × 30’s ; As per DRAP policy
Approval status of product in Reference FLOMAX RELIEF MR of Boehinger Ingelheim, UK
Regulatory Authorities. (MHRA)
Me-too status Tamsolin 0.4mg of M/s GETZ Pharma (Reg#050392)
GMP status GMP inspection dated 18-09-2018 concluded that the
firm was at satisfactory level of GMP Compliance.
Previous remarks of the Evaluator.  Dosage form mentioned on Form-5 is film coated
tablet while brand name suggests capsule dosage form.
Clarification/Revision is required.
 Label claim of applied formulation is not correctly
mentioned. Revision of Form-5 with correct label
claim along with requisite fee is required to be
submitted.
Previous decision(s) Deferred for revision of formulation as per reference
product alongwith applicable fee (M-290).
Deferred for submission of differential fee of Rs.
15,000/- for revision of dosage form (M-293).
Evaluation by PEC The firm has revised label from film coated to capsule in
label claim with submission of fee challan of 5000/-
The firm has submitted fee challan of Rs. 15,000/-
The firm is granted GMP certificate based on inspection
dated 19-10-2019.
1761. Name and address of manufacturer / M/s Sigma Pharma International Pvt. Limited E-50,
Applicant N.W.I.Z., Port Qasim Karachi
Brand Name +Dosage Form + Strength Citrosalt 4gm Sachet
Composition Each Sachet contains:-
Sodium Bicarbonate…………1.76gm
Sodium Citrate Anhydrous…….0.63gm
Citric Acid Anhydrous………….0.72gm
Tartaric Acid…………………….0.89gm
Diary No. Date of R& I & fee 17-11-2014 (217), Rs. 20,000/-
Pharmacological Group Antacids
Type of Form Form-5
Pack size & Demanded Price Packs 20’s & 100’s; As per SRO

Me-too status CITRO SODA Sachet of Abbott Lab
report concludes that on the basis of observation made
by the panel it is concluded that firm has acceptable level
of GMP.
Previous decision(s) Deferred for confirmation of formulation approval in
stringent regulatory agencies (M-246).
Deferred for revision of formulation as per reference
product (M-293).
Evaluation by PEC The firm has revised the strength of sachet as per me-too
reference which is approved by Registration Board in
289th meeting after correction in composition.
Each 4gm of Sachet contains:-
Sodium Bicarbonate…………1.716gm
Sodium Citrate Anhydrous…….0.613gm
Citric Acid Anhydrous………….0.702gm
Tartaric Acid…………………….0.858gm
Me-too composition:
Citrosoda Regular
Each 4gm of sachet contains:-
Sodium Bicarbonate …………….1.716gm
Sodium Citrate……......0.613gm
Citric Acid…................0.702gm
Tartaric Acid…………0.858gm
The firm has submitted fee challan of PKR. 20,000/-
(deposit slip # 1915920) dated 06-03-2020 for revision
of formulation.
dated 19-10-2019.
Decision: Approved with innovator’s specifications and change of brand name.
1762. Name and address of manufacturer / M/s Sigma Pharma International Pvt. Limited E-50,
Applicant N.W.I.Z., Port Qasim Karachi
Brand Name +Dosage Form + Strength Sofnac SR Tablet 100mg
Composition Each film coated sustained release tablet contains:
Diclofenac Sodium…………..100mg
Diary No. Date of R& I & fee Dy. No. 202, 01-02-2017, Rs.20,000/- (7-01-2017)
Pharmacological Group Non-steroidal anti-inflammatory agent (NSAID)
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, As per SRO
Approval status of product in Reference Dicloflex Retard 100 mg prolonged release tablet by M/s
Regulatory Authorities. Dexcel Pharma Ltd. MHRA approved
Me-too status Sintral SR Tablets 100mg of M/s Neomedix (R.#
081413)
report concludes that on the basis of observation made
by the panel it is concluded that firm has acceptable level
of GMP.
Previous decision(s) Deferred for confirmation of formulation approval in
reference stringent regulatory agencies (M-246).
Deferred for submission of fee of Rs. 5000/- for revision
of master formulation (M-293).

Evaluation by PEC Approval status of applied formulation has been verified
in MHRA.
The firm has submitted revised master formulation with
hypromellose as sustained release ingredient.
The firm has submitted fee of PKR. 5000/- (deposit slip
# 1915921) dated 06-03-2020 for revision of
formulation.
dated 19-10-2019.
Decision: Approved.
1763. Deleted due to Duplication in agenda
1764. Name and address of manufacturer / M/s Vega Pharmaceuticals (pvt.) Ltd, Lahore
Applicant
Brand Name +Dosage Form + Strength Clarith 250mg Tablets
Clarithromycin……..250mg
Diary No. Date of R& I & fee Dated 29.04.2013 Rs. 20,000/- (photocopy)
Type of Form Form-5
Pack size & Demanded Price Rs. 350/10’s
Approval status of product in Reference Clarithromycin 250 mg Film-coated Tablets. MHRA
Me-too status Clarital 250mg Tablet.( Reg. No. 85501)
GMP status
Previous decision(s) Deferred for the submission of following (M-261)
i. Inspection report
ii. Commitment as per decision of board
iii. Finished product specification are incomplete.
iv. Fee Rs. 8000/- and 12000/- is Photocopy
v. Approval status in reference countries and Pakistan
Evaluation by PEC The firm has submitted copy of inspection report dated
09-01-2019 & 21-03-2019 concludes that the firm is
operating at fair level of compliance.
The firm has claimed USP specifications and submitted
commitments as per 251st meeting of Registration
Board.
Decision: Approved.
1765. Name and address of manufacturer / M/s Wilson’s pharmaceuticals, 387-388, I-9, Industrial
Applicant Area, Islamabad
Brand Name +Dosage Form + Strength WILBOG TABLETS 50mg
Eltrombopag Olamine eq. to Eltrombopag free
acid………..50mg
Pharmacological Group Thrombopoietin Receptor Agonist
Type of Form Form-5
Finished product Specification In-house specifications
Approval status of product in Reference PROMACTA Tablet of Novartis Pharms , (USFDA
Regulatory Authorities. approved)
Me-too status Revolade Tablet 50mg of GSK, Karachi (Reg#069585)
GMP status GMP Inspection conducted on 24-01-2018 concluded
that the firm was operating at a very good level of GMP

Previous decision(s) Deferred for clarification of pharmacological group of
applied formulation (M-290).
Evaluation by PEC The firm has submitted that Eltrombopag Olamine
belongs to pharmacological group of thrombopoietin
receptor agonists as per FDA reference product.
1766. Name and address of manufacturer / M/s Siam Pharmaceuticals,
Brand Name +Dosage Form + Strength Simax 0.4mg Capsule
Tamsulosin Hydrochloride as SR pellets……..…0.4 mg
Diary No. Date of R& I & fee Dy.No 13083 dated 09-04-2018 Rs.20,000/- Dated 09-
04-2018
Pharmacological Group Alpha1 Adrenoceptor antagonists
Type of Form Form-5
Pack size & Demanded Price 1x10’s, 2x10’s/As per SRO
Approval status of product in Reference Flomax 0.4mg capsule by M/s Boehringer Ingelheim
Regulatory Authorities. Pharmaceuticals (USFDA Approved)
Me-too status M-Sol 0.4mg Capsule of M/s Regal Pharma
(Reg.#081977)
unanimously recommend grant renewal of DML 000711
for approved tablet general and Capsule general section,
to M/s Siam Pharmaceuticals Islamabad
Previous remarks of the Evaluator.  Source of pellets not submitted by the firm.
Previous decision(s) Deferred for source of pellets, along with stability
studies data, GMP certificate of supplier and differential
fee in case of import of pellets (M-290).
Evaluation by PEC The firm has submitted following:
Source of pellets: M/s Vision Pharmaceuticals
The firm has submitted revised label claim as per
reference alongwith submission of fee of Rs. 5000/-
(Deposit slip # 2040588) dated 28-08-2020.
Decision: Approved.
1767. Name and address of manufacturer / M/s Bosch Pharmacetuicals (Pvt) Ltd. (Plant-II), Plot
Applicant No. 209, Sector 23, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Ultraquin Plus Cream
Hydroquinone……………...4 % w/w
Fluocinolone Acetonide……0.01 % w/w
Tretinoin…………………....0.05 % w/w
Pharmacological Group Depigmenting agent
Type of Form Form 5
Pack size & Demanded Price 1’s x 15gm; As per PRC
Me-too status Hydrocin Cream of M/s Fynk Pharmaceuticals (Reg.#
081262)
GMP status Last GMP Inspection dated 7-9-2016 with conclusive
remarks of Acceptable level of cGMP compliance.
Previous remarks of the Evaluator. Latest inspection report conducted within one year shall
be submitted.

Previous decision(s) Deferred for submission of latest inspection report
conducted within one year by DRAP (M-274).
Evaluation by PEC The firm has submitted copy of inspection report dated
05-11-2019 concludes that the firm was considered to be
operating at an acceptable of compliance with GMP
guidelines.
Decision: Deferred for clarification of pharmacological group for applied formulation.
1768. Name and address of manufacturer / M/s Fresh Pharmaceuticals, Plot # 7, Street# S-6,
Applicant National Industrial Zone, Rawat
Brand Name +Dosage Form + Strength FERDOX TABLETS 20mg
Piroxicam (as beta cyclodextrin)…………20 mg
Diary No. Date of R& I & fee Rs. 20,000/- vide Dy. No. 1943 dated 05-11-2015
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s / as per price fixed by Government
Approval status of product in Reference Cycladol tablet (ANSM approved)
Me-too status Pirujin Tablet M/s Jupiter Pharma
GMP status GMP inspection report dated 02-10-2019 is complying
satisfactory level of cGMP as of today.
Previous decision(s) Deferred for clarification as firm claimed their
formulation as film coated tablet while innovator’s
brand is uncoated tablet (M-255).
Evaluation by PEC The firm has revised master formulation with uncoated
composition alongwith fee challan of Rs. 5000/- (deposit
slip # 2044499) dated 25-08-2020.
1769. Name and address of manufacturer / Applicant: M/s Honig Pharmaceuticals Labs. –
Applicant Rawalpindi 14 KM, Adyala Road, Rawalpindi;
Contract manufacturer: M/s Vision Pharmaceuticals
Plot # 22-23, Industrial Triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Strength SEC 40mg IV Injection
Omeprazole as sodium……40mg
PKR 50,000/-: 14.03.2018
Type of Form Form 5
Approval status of product in Reference OMEPRAZOLE SANDOZ IV omeprazole (as sodium)
Regulatory Authorities. 40mg powder for injection vial. TGA approved
GMP status The firm M/s Vision Pharmaceuticals was inspected on
11.02.2019, wherein the panel recommended the grant
of GMP certificate.
The firm M/s Honig Pharmaceuticals was inspected on
11.10.2018 and reported complying GMP.
Previous remarks of the Evaluator.  The shelf-life of the product in TGA is 18 months.
 The firm M/s Honig Pharmaceuticals has submitted
inspection report for DML renewal, wherein 04
sections have been mentioned.

 The firm M/s Honig Pharmaceuticals has submitted a
list of 09 approved product for contact manufacturing.
list of 03 products applied for contact manufacturing
by M/s Honig Pharmaceuticals.
 Adjustment of weight of API as per salt factor is
required in Master Formula.
 The firm has mentioned the dosage form as injection.
However, the composition and manufacturing outlines
depict that the product is lyophilized powder for
injection.
 The firm has provided copy of contract manufacturing
agreement between the applicant and manufacturer.
 The firm was asked to clarify the lyophilization
process, but the firm did not reply.
 Clarify whether the product is filled and lyophilized
or only lyophilized powder is filled.
 Clarify the dosage form.
Evaluation by PEC The firm has submitted calculation of API as per Salt
factor. Regarding method of manufacturing, the firm
submitted that we will fill “Ready to fill Lyophilized
Powder” in sterile vials under aseptic sterile conditions
and microbiologically controlled environment.
Moreover, the firm stated that mistakenly the term
injection was mentioned in the Form-5 of the product
and the correct dosage form is Lyophilized Powder for
Injection. However, fee of such revision is not
submitted.
Decision: Deferred for submission of fee for revision of dosage form.
Islamabad
Brand Name +Dosage Form + Strength Moxing 400mg/250ml IV Injection
Moxifloxacin as hydrochloride……400mg
PKR 50,000/-: 14.03.2018
Type of Form Form 5
Pack size & Demanded Price (250ml) 1’s; As per SRO
Regulatory Authorities. hydrochloride) intravenous infusion solution bottle.
TGA approved
of GMP certificate.

Previous remarks of the Evaluator.  The firm M/s Honig Pharmaceuticals has submitted
 The firm mentioned HDPE as primary packaging.
Then changed to LDPE). The reference product is
packed in Glass Type I clear bottle.
 The firm was asked for adjustment of weight of API as
per salt factor. The firm did not revised the same.
Previous decision(s) Deferred for clarification about the packaging (M-289)
Evaluation by PEC The firm has submitted that mistakenly the packaging
material mentioned as LDPE in Form-5 of the product
dossier. However, we will use Packaging material as
Clear Glass bottles of USP Type-I. However, fee of such
revision is not submitted.
Islamabad
Brand Name +Dosage Form + Strength Xamp 40mg IV Injection
Esomeprazole as sodium……40mg
PKR 50,000/-: 14.03.2018
Type of Form Form 5
Pack size & Demanded Price 1’s; As per DPC
Approval status of product in Reference NEXIUM IV esomeprazole 40mg (as sodium) powder
Regulatory Authorities. for injection vial. TGA approved
of GMP certificate.
Previous remarks of the Evaluator.  The firm M/s Honig Pharmaceuticals has submitted
 The firm has mentioned the dosage form as injection.
However, the composition and manufacturing outlines
depict that the product is lyophilized powder for
injection.

 The firm has mentioned 33% potency of lyophilized
powder, but did not clarify the other 67% composition.
 The firm was asked to clarify the lyophilization
process, but the firm did not reply.
 Clarification whether the product is filled and
lyophilized or only lyophilized powder is filled.
 Clarification of the dosage form.
 Clarification about the composition of the dosage form
(powder).
Evaluation by PEC The firm has submitted calculation of API as per Salt
factor. Regarding method of manufacturing, the firm
submitted that we will fill “Ready to fill Lyophilized
Powder” in sterile vials under aseptic sterile conditions
and microbiologically controlled environment.
Moreover, the firm stated that mistakenly the term
injection was mentioned in the Form-5 of the product
and the correct dosage form is Lyophilized Powder for
Injection. However, fee of such revision is not
submitted.
1772. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, Pvt limited, 14 Km,
Applicant Adayala Road, Post Office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Zevast Tablet 10mg/10mg
Ezetimibe ……………….10mg
Simvastatin.……………..10mg
Pharmacological Group Cholesterol Absorption Inhibitor/HMG-CoA reductase
inhibitor
Type of Form Form-5
Finished product Specification Manufacturer’s
Pack size & Demanded Price 1 × 10’s & As per SRO
Approval status of product in Reference Not Provided
Me-too status Simbex tablet 10/10 of Searle Pharma
the report concludes issuance of GMP certificate for
export purpose.
Previous remarks of the Evaluator. Non-pharmacopoeial as is not present in B.P. & U.S.P.
The drug is applied as film-coated while it is approved
in USFDA, MHRA, Netherland, Australia & France as
uncoated.
Previous decision(s) Deferred for clarification of applied formulation since
reference product is approved as uncoated tablet
whereas firm has applied for film coated tablet.(M-278)
Deferred for submission for revision of formulation (M-
283).
Evaluation by PEC The firm has submitted revised Form-5 where the
finished product is uncoated tablet in line with reference
country as follows
The firm has submitted fee challan of PKR 5000/-
(deposit slip 2038084) dated 02-09-2020.
inhibitor
Type of Form Form-5
export purpose.
uncoated.
Deferred for submission for revision of formulation
(M-283).
country as follows
inhibitor
Type of Form Form-5

export purpose.
uncoated.
Deferred for submission for revision of formulation
(M-283).
country as follows
1775. Name and address of manufacturer / M/s. Legacy Pharmaceuticals (Pvt) Ltd, 111-A,
Brand Name +Dosage Form + Strength Ribena-FF Tablets
Composition Each chewable tablet contains:-
Iron polymaltose complex equivalent to elemental iron
……….100mg
Folic Acid……..0.75mg
Diary No. Date of R& I & fee 21-1-2010, Dy No. 46, Rs.8000, Rs.12000, 4-8-2015
Pharmacological Group Antianaemic
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price 10’s/ Rs.120.00
Approval status of product in Reference N/A
Me-too status Ferrum FA of M/s PharmEvo
GMP status Inspection date 18/07/2019. The Panel recommended
renewal of DML.
Previous remarks of the Evaluator. Firm has claimed mfg. specs and the product is not
present in available versions of USP & BP.
Previous decision(s) Deferred for clarification of dosage form as firm has
applied for chewable tablet whereas manufacturing
method states Film coating also (M-267).
Evaluation by PEC The firm has submitted clarification that our product is
uncoated and chewable tablet but due to typing mistake
master formulation included coating materials. Revised
master formula for chewable tablet is submitted by the
firm.
1776. Name and address of manufacturer / M/s. Welwink Pharmaceuticals, Gujranwala Cantt.
Applicant
Brand Name +Dosage Form + Strength Olexa 10 mg Tablet
Escitalopram as Oxalate………………….........10 mg
Diary No. Date of R& I & fee Dy. No. 4309; 13-03-2017; Rs.20,000/- (13-03-2017)
Pharmacological Group Antipsychotic/ Selective serotonin reuptake inhibitors
(SSRI)

Type of Form Form-5
Finished product Specification U.S.P.
Pack size & Demanded Price 10’s & 14’s / As per SRO.
Approval status of product in Reference CIPRALEX 10mg film-coated tablets by M/s
Regulatory Authorities. H.Lundbeck (MHRA approved)
Me-too status Citanew 10 mg Tablet by Hilton, (Reg. # 036426).
the report concludes :
“Firm was operating at satisfactory level of GMP
compliance for all sections except Liquid Injectable
section for which the firm was advised to provide Liquid
Particle counter and TOC at earliest.”
Previous remarks of the Evaluator.  Addition of Methylene chloride in master
formulation needs justification.
Previous decision(s) Deferred for change of composition for film coating
since methylene chloride is banned excipient (M-279).
Deferred for submission of fee for revision of
formulation (M-285).
Evaluation by PEC The firm has submitted revised Form-5 for film coating
composition without methylene chloride and with
following label claim as below:
Escitalopram as Oxalate…………….........10 mg
The firm has submitted fee challan of Rs. 5000/- (deposit
slip # 1909921) dated 31-12-2019.
Decision: Approved.
1777. Name and address of manufacturer / M/s Baxter Pharmaceuticals, A-1/A, Phase-1, S.I.T.E.
Brand Name +Dosage Form + Strength Baxtran Syrup 5ml
Sulfamethoxazole…..…200mg
Trimethoprim……….…40mg
Diary No. Date of R& I & fee Dy. No.325, R&I Dated 18.12.2014, Rs. 20,000
Pharmacological Group Macrolides, Anti-infective.
Type of Form Form 5
Pack size & Demanded Price 1’s & Rs.40/-
Approval status of product in Reference Trimethoprim+Sulphamethoxazole 40+200mg
Regulatory Authorities. By Teva , USFDA
Me-too status Not available
GMP status Last GMP Inspection 05.04.2017 concludes acceptable
Previous remarks of the Evaluator. Me-too couldn’t be confirmed.
Previous decision(s) Deferred for evidence of me-too in the same dosage form
and strength (M-270).
Evaluation by PEC 000384: Septran Paediatric suspension of GSK
The submitted me-too and international availability is of
suspension whereas the applied formulation is syrup.
Decision: Deferred for evidence of applied formulation in syrup dosage form in reference
regulatory authorities.
1778. Name and address of manufacturer / M/s Baxter Pharmaceuticals, A-1/A, Phase-1, S.I.T.E.
Brand Name +Dosage Form + Strength Dinar Dry suspension 250mg
Composition Each 5ml suspension contains
Cephradine ……………250mg
Diary No. Date of R& I & fee Dy. No.317, R&I Dated 18.12.2014, Rs. 20,000
Pharmacological Group 1st generation cephalosporin antibiotic
Type of Form Form-5
Finished product Specification U.S.P.
Pack size & Demanded Price 120ml x1’s & Rs.230/=
Me-too status Cephradine 250mg suspension by Aries
GMP status Last GMP Inspection 05.04.2017 concludes acceptable
Previous decision(s) Deferred for verification of the manufacturing facility
(M-270).
Evaluation by PEC The firm has provided Dry Powder Suspension
(Cephalosporin) section as evidence from licensing
letter vide letter No.F.2-14/2007-Lic dated 25th Feb,
2011.
Decision: Approved.
1779. Name and address of manufacturer / "M/s Amarant Pharmaceuticals Pvt Ltd.
Applicant 158-D, Tore, Gadap Road, Super Highway, Karachi"
Brand Name +Dosage Form + Strength Osvir dry suspension 12mg/ml
Composition Each ml of reconstituted suspension contains:
Oseltamivir as phosphate…..…..12mg
Diary No. Date of R& I & fee Dy.No. 9453 dated 30/04/2020 Rs. 20,000/-
Type of Form Form-5
Finished product Specification Innovator’s
Approval status of product in Reference Tamiflu 12mg/ml for Suspension (oseltamivir as
Regulatory Authorities. phosphate) by M/s Roche, Italy AIFA Approved.
Me-too status Ozenta 12mg Dry Suspensin by M/s Hilton, reg. No.
42219
GMP status GMP inspection dated 24-07-2018, current GMP
compliance is rated as Good.
 Clarification since the attached fee challan is for
Amaquin (50mg/5ml).
 Submission of evidence of approval of applied
formulation as “Syrup” 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.
Evaluation by PEC The firm has submitted that erroneaously fee challan of
Amaquin 50mg /5ml was compiled with the dossier
instead of Osvir Dry Suspension. Correct copy of fee
challan of Osvir Dry Suspension is enclosed.
The firm has further stated that in the registration
dossier, we applied for Dry suspension as per reference
formulation. Copy of submitted Form-5 is enclosed.
Decision: Approved.
1780. Name and address of manufacturer / M/s The Searle Company Limited 32- Km Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Comfyl Syrup
Acefylline Piperazine……………..….45 mg
Diphenhydramine hydrochloride………..8 mg
Diary No. Date of R& I & fee Fast Track, 10-05-13, Rs. 60,000/-, 10-05-13
Type of Form Form-5
Pack size & Demanded Price 120 ml Rs. 50/-
Me-too status Acefyl cough Syrup by Nabiqasim
GMP status Last inspection report dated 30-01-2019 confirms that
firm is operating at a Good level of GMP compliance.
Previous decision(s) Deferred for review of formulation by review committee
(M-242).
Evaluation by PEC The firm has submitted that DRAP has already granted
registration of same formulation to many pharmaceutical
companies, some brands are mentioned below for your
reference:
Acefyl cough syrup of M/s Nabiqasim (Reg#023394)
Cefyl ESF Syrup of M/s Epla labs (Reg#024432)
Cosome DA syrup of M/s Martin Dow (Reg#075906)
Ebrantil EXP syrup of M/s Akhai (Reg#053002)
In the light of above, we would request you to grant us
registration.
authorities adopted by Registration Board in 278th meeting
1781. Name and address of manufacturer / M/s Medisure Laboratories Pakistan (pvt) Ltd. A-115,
Applicant SITE, Karachi.
Brand Name +Dosage Form + Strength Win-Spa 40mg/2ml IM/IV Injectable
Drotaverine HCl……….40mg
Diary No. Date of R& I & fee Dy. No: 1619 dated, 24.09.2012 Rs.20,000/-
Type of Form Form-5
GMP status Inspection report dated 19/07/2019 which concludes that
GMP compliance level is rated as good.
Previous decision(s) Deferred for confirmation of approval status by
reference regulatory authorities (M-258).
Evaluation by PEC The approval status of applied formulation has been
confirmed by three European countries Bulgaria,
Romania, Hungary.
Decision: Approved with innovator’s specifcations.
1782. Name and address of manufacturer / M/s Vision Pharmaceuticals Plot # 22-23, Industrial
Brand Name +Dosage Form + Strength CINPRO Dry suspension 125mg/5ml
Composition Each 5ml Contains:-
Ciprofloxacin base taste masked pellets 25% eq. to
Ciprofloxacin…….125mg
Diary No. Date of R& I & fee Dy No.2055 dated 19-03-15, Rs. 20,000/-
Type of Form Form-5

Pack size & Demanded Price As Per SRO/ Pack of 60ml
Approval status of product in Reference Cipro 125mg/5ml of Bayer Healthcare,(USFDA)
Me-too status Novidat 125mg/5ml of Sami Pharmaceuticals
of GMP certificate.
Evaluation by PEC The firm has revised dosage form from suspension
to Dry powder suspension alongwith submission of
fee of PKR 20,000/- (deposit slip # 1926356) dated
12-08-2020.
Decision: Approved with USP specifications. Diluent should be as per innovator.
1783. Name and address of manufacturer / M/s Vision Pharmaceuticals Plot # 22-23, Industrial
Brand Name +Dosage Form + Strength CINPRO Dry suspension 250mg/5ml
Composition Each 5ml Contains:-
Ciprofloxacin base taste masked pellets 25% eq. to
Ciprofloxacin…….250mg
Diary No. Date of R& I & fee Dy No.2055 dated 19-03-15, Rs. 20,000/-
Type of Form Form-5
Pack size & Demanded Price As Per SRO/ Pack of 60ml
Approval status of product in Reference Ciproxin® 250 mg/5 ml granules and solvent for oral
Regulatory Authorities. suspension by M/s Bayer Healthcare, MHRA approved
Me-too status Novidat 250 mg/5ml of Sami Pharmaceuticals
of GMP certificate.
Evaluation by PEC The firm has revised dosage form from suspension
to Dry powder suspension alongwith submission of
fee of PKR 20,000/- (deposit slip # 1926357) dated
12-08-2020.
Decision: Approved with USP specifications. Diluent should be as per innovator.
1784. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt) Ltd 62-Industrial
Applicant Estate, Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Pulmonol M Syrup
Carbocysteine……...100mg
Diary No. Date of R& I & fee Dy No. 547, 03-02-2015; PKR 20,000/-, 03-02-2015
Pharmacological Group Mucolytic agent
Type of Form Form-5
Pack size & Demanded Price 120ml, as per brand leader
Approval status of product in Reference BRONCATHIOL CHILDREN, oral solution of
Regulatory Authorities. MELISANA Pharma (ANSM approved)
Me-too status Rhinathiol Syrup by Sanofi
inspection dated 30-04-2019.

Previous decision(s) Deferred for following (M-269).
Change of brand name as the same is registered for
different active ingredient
Latest GMP inspection report conducted within 1 year
Evidence of approval by reference regulatory authorities
approved by Registration Board in 249th
meeting
Clarification regarding the submitted innovator’s
specification as it was already declared that this product
is not registered in any reference regulatory authority
We will change the brand name of the said applied
formulation.
GMP certificate submitted.
Approval status of applied formulation in ANSM has
been verified.
Reference formulation is in oral solution while applied
formulation is syrup.
1785. Name and address of manufacturer / M/s CCL Pharmaceuticals (Pvt) Ltd 62-Industrial
Applicant Estate, Kot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Pulmonol M Plus Syrup
Carbocysteine……….100mg
Promethazine hydrochloride….2.5mg
Diary No. Date of R& I & fee Dy No. 542, 03-02-2015; PKR 20,000/-, 03-02-2015
Pharmacological Group Mucolytic agent ; Antihistamine
Type of Form Form-5
Pack size & Demanded Price 120ml, as per brand leader
Approval status of product in Reference BRONCATHIOL Promethazine Syrup of MELISANA
Regulatory Authorities. Pharma (ANSM approved)
Me-too status Rhinathiol Syrup by Sanofi
Previous decision(s) Deferred for following (M-269).
Change of brand name as the same is registered for
different active ingredient
Latest GMP inspection report conducted within 1 year
Evidence of approval by reference regulatory authorities
approved by Registration Board in 249th
meeting
Clarification regarding the submitted innovator’s
specification as it was already declared that this product
is not registered in any reference regulatory authority
We will change the brand name of the said applied
formulation.
GMP certificate submitted.
Approval status of applied formulation in ANSM has
been verified.
1786. Name and address of manufacturer / M/s Caylex Pharmaceuticals, (Pvt) Limited, 27-Km
Applicant Raiwind road Lahore.
Brand Name +Dosage Form + Strength AZOLOD Tablets 500mg

Azithromycin as Dihydrate…………..500mg
Diary No. Date of R& I & fee Dy.No. 738, 8000/- dated 29-12-2010, 12000/- dated 28-
10-2013
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 20, 50,100, 250 and 500 tablets
Approval status of product in Reference Azithromycin 500 mg Film-Coated Tablets by TEVA UK
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Zetro 500mg Tablet by Getz Pharma (Reg # 053120)
GMP status The firm has submitted copy of letter from QA division
vide letter No.F. 4-17/98-QA dated 4th January, 2018 in
which the Director QA & LT has allowed resuming the
production of the firm M/s Caylex Pharma except in
Cephalosporin section.
Previous decision(s) Deferred for rectification f following: (M-250)
a. Evidence of approval of section from Drug Licensing
Division is not submitted.
b. Methylene chloride is used in film coating which is
class II solvent and its use has been restricted because of
its inherent toxicity.
c. Inspection of the firm was carried out on 13-05-14 by
the panel of inspectors and number of observations/
shortcomings pointed out during the inspection.
Evaluation by PEC  The firm has submitted coating without methylene
chloride.
 The firm has been granted GMP certificate based on
Decision: Deferred for verification of R & I details of applied formulation.
Brand Name +Dosage Form + Strength IROP Syrup
Iron protein succinylate 800mg equivalent to elemental
Iron……………..40mg
Diary No. Date of R& I & fee Dy.No. 738, 8000/- dated 29-12-2010, 12000/- dated 28-
10-2013
Pharmacological Group Hematinic
Type of Form Form-5
Finished product Specification Manufacturer specs
Pack size & Demanded Price As per SRO/ Pack of 30, 60,90, 120 and 450ml
Approval status of product in Reference Approved in Italy
Me-too status Wincuss Syrup 800mg/15 ml of Winthrox Karachi.
Previous decision(s) Deferred for rectification of following: (M-250)
b. Inspection of the firm was carried out on 13-05-14 by
Evaluation by PEC  The firm has been granted GMP certificate based on
Brand Name +Dosage Form + Strength O-CIN Tablet 400mg
Ofloxacin…………………400mg
Diary No. Date of R& I & fee Dy.No. , 8000/- dated 29-12-2010, 12000/- dated 28-10-
2013
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 10, 20, 30, 50, 100, 250, and 500’s
Approval status of product in Reference Tarivid 400 of MHRA approved
Me-too status Clamocid 400mg Tablets by M/s Rock Pharmaceuticals
Laboratories
b. Methylene chloride is used in film coating which is
class II solvent and its use has been restricted because of
its inherent toxicity.
Evaluation by PEC  Diary No. is not mentioned.
 The firm has submitted coating without methylene
chloride.
Brand Name +Dosage Form + Strength BISUB Tablet 265mg
Bismuth Subsalicylate……………...265mg
2013
Pharmacological Group Mucosal protective
Type of Form Form-5
Me-too status Not confirmed

b. Evidence of approval of same generic, dosage form in
reference agencies is not submitted.
c. Applied drug is available locally as chewable tablet
however firm has applied film coated.
d. Inspection of the firm was carried out on 13-05-14 by
Evidence of approval of applied formulation in reference regulatory authorities adopted by
Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) along
Brand Name +Dosage Form + Strength BISUB Suspension
Bismuth subsalicylate……….….88mg
Diary No. Date of R& I & fee Dy.No. ,8000/- dated 29-12-2010, 12000/- dated 28-
10-2013
Pharmacological Group Anti-diarrhoeal
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60, 90, 120, and 450ml
Approval status of product in Reference Pepti-Calm 525.6mg/30ml Oral Suspension of The Boots
Regulatory Authorities. Company (MHRA approved)
Me-too status BISMOL Syrup of Macter International
Division is required.
b. Inspection of the firm was carried out on 13-05-14 by
Brand Name +Dosage Form + Strength K-ZIM Syrup 100mg/ 5ml
Cefixime as Trihydrate………....100mg
2013
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60, 90, 120, 450ml
Approval status of product in Reference Cefixime 100 mg/5 ml Powder for Oral Suspension by M/s
Regulatory Authorities. Generics Ltd (MHRA Approved)
Me-too status Cefim Suspension 100mg/5ml by M/s Hilton Pharma
(Reg#022108)
b. Master formulation of liquid oral dosage form is
submitted.
c. Precautions/controls submitted for liquid oral dosage
form.
d. Finished product specifications are not submitted.
e. Inspection of the firm was carried out on 13-05-14 by
Moreover, the status of the section for applied formulation
is not clear from the report.
Evaluation by PEC  Reference formulation is Powder for oral suspension
while applied formulation is syrup.
authorities adopted by Registration Board in its 275th meeting.
Brand Name +Dosage Form + Strength CAYMOL Plus Tablet
Paracetamol…………...200mg
Aspirin……………..…300mg
2013
Type of Form Form-5
Pack size & Demanded Price As per SRO/ Pack of 30, 60, 90, 120, 450ml
Approval status of product in Reference Not confirmed.
Me-too status Liskoprin of Lisko Pvt Limited.
Division is not provided.
b. Evidence of approval of same generic, dosage form and

strength in reference drug agencies need to be submitted.
Evaluation by PEC  Approval status in reference agency is required to be
submitted.
Brand Name +Dosage Form + Strength CAYBION Capsules 50mg
Diclofenac sodium enteric coated pellets
(32%)……50mg
2013
Type of Form Form-5
Approval status of product in Reference Approved in ANSM
Me-too status Amfac Capsules of Ambrosia Pharma (Reg#056576)
strength in reference agencies is not submitted.
c. Source of Diclofenac sodium pellets, their composition,
certificate of analysis, stability studies as per zone IV and
in case of import of pellets, legalized GMP certificate of
the source along with the requisite fee prescribed under the
rules is not submitted.
Evaluation by PEC  Diary no. is missing
 Source of Pellets: M/s Vision Pharma (Diclofenac
sodium Enteric coated pellets 32%).
Brand Name +Dosage Form + Strength CAYBION Capsules SR 100mg
Diclofenac sodium SR pellets (32%)……………..100mg
2013
Type of Form Form-5
Approval status of product in Reference Diclomax Retard 100mg modified release capsules of
Regulatory Authorities. Galen Ltd., UK (MHRA approved)
Me-too status Flamex SR capsules 100mg of M/s Werrick Pharma
(Reg#020592)
strength in reference agencies is not submitted.
c. Source of Diclofenac sodium pellets, their composition,
certificate of analysis, stability studies as per zone IV and
in case of import of pellets, legalized GMP certificate of
the source along with the requisite fee prescribed under the
rules is not submitted.
shortcomings pointed out during the inspection
Evaluation by PEC  Source of Pellets: M/s Vision Pharma (Diclofenac
sodium SR pellets 32%)
 Diary no. is missing.
Brand Name +Dosage Form + Strength C-PHOS Tablet 250mg
Chloroquine Phosphate …………...250mg
2013
Type of Form Form-5
Approval status of product in Reference MHRA approved
Me-too status Cloroquin 250mg Tablet of klifton Pharma
(Reg#058332)
a. Formulation is approved in reference drug agencies as
uncoated tablet however applied formulation is film
coated.
b. Reference of finished product spec need to be submitted
as it is included in official pharmacopeia.
Evaluation by PEC  Diary no. is missing.
Brand Name +Dosage Form + Strength GEMFLOX Tablet 320mg
Gemifloxacin as mesylate……………..…..320mg
2013
Type of Form Form-5
Finished product Specification Manufacturer’s specs
Approval status of product in Reference Factive Tablets of LG Life Sciences (USFDA approved)
Me-too status Gemixa Tablets of Bosch Pharma Karachi
b. Methylene chloride is used as coating solvent which is
class II as per ICH and its use has been restricted due to its
inherent toxicity
chloride.
Brand Name +Dosage Form + Strength MOXILEX Tablet 400mg
Moxifloxacin as Hydrochloride…………..400mg
Diary No. Date of R& I & fee Dy.No. 8000/- dated 29-12-2010, 12000/- dated 28-10-
2013
Type of Form Form-5
Finished product Specification Manufacturer’s specs

Approval status of product in Reference Avelox of Bayer UK (MHRA approved)
Me-too status Avelox of Bayer Health Care Karachi
b. Methylene chloride is used as coating solvent which is
class II as per ICH and its use has been restricted due to its
inherent toxicity
chloride.
Decision: Approved with innovator’s specifications. Reference shall be sent to budget and
accounts for verification of fee challan.
Case no. 02 Registration applications for local manufacturing of (Veterinary) drugs

a. New cases
1798. Name and address of manufacturer / M/s Intervac (Pvt.) Limited., 18-km, Lahore Sheikhupura
Applicant Road, Sheikhupura, Pakistan
Brand Name +Dosage Form + Strength IMMUNE PLUS LIQUID
Composition Each liter contains:
Vitamin E………200,000mg
Sorbitol…………50,000mg
Choline Chloride…….50,000mg
Propylene glycol………50,000mg
Selenium…………….150mg
Zinc ………………..4000mg
Pharmacological Group Vitamin and minerals
Type of Form Form-5
Finished Product Specification Manufacturer specifications
Pack size & Demanded Price 50ml, 100ml, 200ml, 400ml, 500ml, 1000ml;
Decontrolled
Me-too status DELTI IMMUNE of France
GMP status After thorough evaluation of documents and inspection of
the unit dated 28-02-2019 & 19-06-2019, the panel
members decided to recommend the renewal of Drug
manufacturing license.
Remarks of the Evaluator. The submitted me-too reference could not be verified.
 Rationale of using propylene glycol in formulation.

Brand Name +Dosage Form + Strength BRO-MEN Liquid
Bromhexine hydrochloride………20mg
Menthol………………….40mg
Pharmacological Group Expectorant
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1Litre, 2.5Litre, 5 Litre;
Decontrolled
Me-too status BROMENT Oral Solution of M/s Baariq Pharma
(Reg # 094458)
Brand Name +Dosage Form + Strength INTERVAC DROP
Monobasic potassium phosphate…….0.37 mg
Disodium phosphate dihydrate……0.72 mg
Sodium chloride………………..7.65 mg
Disodium Edetate dihydrate……0.50 mg
Methylene Blue………………..0.17 mg
Pharmacological Group Vaccine diluent
Type of Form Form-5
Pack size & Demanded Price Plastic bottles of 30ml, 36ml, 100ml; Decontrolled
Me-too status VACCI DROP Solvent of M/s Leads Pharma
(Reg#046566)
Decision: Approved with innovator’s specifications and change of brand name.
Brand Name +Dosage Form + Strength BLUE-VAC Granules
Sodium Thiosulphate………….100mg
Patent Blue Color…………….170mg
Pharmacological Group Blue Colouring Agent
Type of Form Form-5
Pack size & Demanded Price 100gm, 200gm, 500gm, 1000gm; Decontrolled
Me-too status Not confirmed.
Remarks of the Evaluator. Me-too reference could not be verified.
 Rationale of using Patent Blue color in formulation.
Brand Name +Dosage Form + Strength CYPER POUR-ON SOLUTION
Cypermethrin…………….100mg
Pharmacological Group Insecticide
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, 2000ml; Decontrolled
Me-too status CYPERMET Liquid of M/s Breeze Pharma
(Reg#059165)
Brand Name +Dosage Form + Strength TERMINATOR PLUS (Solution for Spray)
Composition Each litre contains:
Glutaraldehyde....………………..150gm
Cocobenzyldimethylammonium chloride…..….100gm
Diary No. Date of R& I & fee Duplicate, 08-08-2016, 20,000/-, 08-08-2016
Pharmacological Group Broad Spectrum Disinfectant
Type of Form Form-5
Pack size & Demanded Price 500ml, 1 litre, 2.5 litre, 5 litre, 10 litre, 25 litre, 50 litre;
Decontrolled
Me-too status Terminator Solution by Bomac Laboratories
(Newzealand)
Remarks of the Evaluator. Me-too reference of applied formulation could not be
verified.
b. Deferred cases (New section)
Registration Board deferred the cases of M/s Mylab Pvt. Ltd., Khankah Shariff, Bahawalpur for clarification
regarding manufacturing facility whether steroidal or non-steroidal hormone section.
The firm has submitted that we hereby state that we will manufacture non-steroidal hormone products in this
newly approved section. We have also requested to Secretary Licensing Board to issue letter with respective
change.
Liquid Injectable (Hormone) Section: (5molecules/12 products)

1804. Name and address of manufacturer / M/s Mylab PVT. LTD., Khankah Shariff, Bahawalpur
Applicant
Brand Name +Dosage Form + Strength BUSALIN INJECTION
Buserelin Acetate……………0.0042mg eq. to 0.004mg
of Buserelin
Pharmacological Group Gonadotropin-releasing hormone agonist
Type of Form Form 5
Pack size & Demanded Price 10ml × 10’s clear glass vial; Decontrolled
Me-too status CONCEPTAL INJECTION of M/s STAR LAB
(Reg#058939)
GMP status CLB in its 266th meeting held on 24th October, 2018 has
considered and approved the following additional section.
Liquid Injectable (Hormone) Section (DML# 000747).
Remarks of the Evaluator. Follix Injection is mentioned on fee challan. Clarification
is required.
Previous Decision. Deferred for following (M-289):
Clarification regarding manufacturing facility whether
steroidal or non-steroidal hormone section.
Clarification of applied product on fee challan
Evaluation by PEC.
Decision: Approved with innovator’s specifications. The Board further advised the firm to get
approval of change of name for non-steroidal hormone section from Licensing Division before
issuance of Registration letter.
Applicant
Buserelin Acetate……………0.0042mg eq. to 0.004 mg
of Buserelin
Type of Form Form 5
(Reg#058939)
Previous Decision. Deferred for clarification regarding manufacturing facility
whether steroidal or non-steroidal hormone section.
Evaluation by PEC.
Applicant
Buserelin Acetate……………0.0042mg eq. to 0.004mg
of Buserelin
Type of Form Form 5
Pack size & Demanded Price 2.5ml × 10’s clear glass vial; Decontrolled
(Reg#058939)
Evaluation by PEC.
Applicant
Brand Name +Dosage Form + Strength FOLLIX INJECTION
Estradiol dipropionate……………..1.00mg
Pharmacological Group Synthetic Estrogen
Type of Form Form 5
Pack size & Demanded Price 10ml clear glass vial; Decontrolled
Me-too status Agofollin injection of Ghazi Brothers (Reg#028587)
Evaluation by PEC.
Applicant
Brand Name +Dosage Form + Strength FOLLIX INJECTION
Estradiol dipropionate……………..1.00mg
Type of Form Form 5
Me-too status Agofollin injection of Ghazi Brothers (Reg#028587)
Evaluation by PEC.
Applicant
Brand Name +Dosage Form + Strength DROSTEN INJECTION
D-Cloprostenol……………..0.075mg
Pharmacological Group Synthetic Prostaglandin analogue
Type of Form Form 5
Me-too status Delmazine Injectable solution of M/s Prix Pharma1ceutica
(Reg#018842)
Remarks of the Evaluator. The submitted me-too reference is of different strength
i.e.,D-Cloprostenol………….0.075 mg per ml.
whether steroidal or non-steroidal hormone section
Evaluation by PEC. The firm has revised strength as per me-too reference and
submitted fee challan of Rs. 20,000/- (deposit slip #
2053839) dated 01-09-2020.
Applicant
Type of Form Form 5
Me-too status Delmazine Injectable solution of M/s Prix Pharmaceutica
(Reg#018842)
Remarks of the Evaluator. The submitted me-too reference is of different strength
i.e.,D-Cloprostenol………….0.075 mg per ml.
Evaluation by PEC. The firm has submitted fee challan of Rs. 20,000/- (deposit
slip # 2053840) dated 01-09-2020.
Applicant

Type of Form Form 5
Me-too status Delmazine Injectable solution of M/s Prix Pharmaceutica
(Reg#018842)
Remarks of the Evaluator. The submitted me-too reference is of different strength i.e.,
D-Cloprostenol………….0.075 mg per ml.
Evaluation by PEC.
Submission of fee of Rs. 20,000/- for revision of strength of applied formulation.
Approval for non-steroidal hormone section from Licensing Division before issuance of
Registration letter
Applicant
Brand Name +Dosage Form + Strength MYRALIN INJECTION
Lecirelin……………25mcg
Pharmacological Group Synthetic super analogue of GnRH (gonadotropin
releasing hormone)
Type of Form Form 5
Me-too status SERILIN Injection of M/s Selmore Pharma (Reg#071092)
Evaluation by PEC.
Applicant
Pharmacological Group Synthetic superanalogue of GnRH (gonadotropin
releasing hormone)
Type of Form Form 5

Evaluation by PEC.
Applicant
Pharmacological Group Synthetic superanalogue of GnRH (gonadotropin
releasing hormone)
Type of Form Form 5
Evaluation by PEC.
Applicant
Brand Name +Dosage Form + Strength STYROL INJECTION
Stilbestrol Dipropionate……………10mg
Type of Form Form 5
Me-too status BESTEROL Injection of M/s Selmore (Reg#071085)
Evaluation by PEC.
c. Deferred cases (Routine)
1816. Name and address of manufacturer / M/s Elko Organization Pvt Ltd., Plot No. 27 & 28, Sector
Applicant 12-B, North Karachi, Industrial Area, Karachi
Brand Name +Dosage Form + Strength Elkoflor Oral Solution
Florfenicol…………….300mg
Diary No. Date of R& I & fee Dy.No 4474, 07-02-2018, Rs. 20,000/-, 06-02-2018
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 450ml, 500ml,1L,5L; Decontrolled
Me-too status N/A
GMP status MEDIFLOR 30% Oral Solution (Not confirmed)
Previous remarks of the Evaluator. Routine GMP inspection conducted on 13-06-2017 & 06-
of GMP compliance as of today
already approved by DRAP (generic / me-too status)
firm (M-288).
Evaluation by PEC Approval status of applied formulation has been verified
in USFDA in injectable dosage form while applied
formulation is in Oral solution.
1817. Name and address of manufacturer / M/s Univet Pharmaceuticals, 14-Km, Adayala road, post
Applicant office Dahga, Rawalpindi
Brand Name +Dosage Form + Strength Zixx liquid suspension 100ml
Composition Each Litre contains:
Vitamin E acetate…………...200,000mg
Vitamin C (Ascorbic Acid)…….2000mg
Sodium Selenite………………...2200mg
Zinc as sulphate……………....10,000mg
Diary No. Date of R& I & fee Dy. No.925, R&I Dated 09-08-2016, Rs. 20,000/-
(05.08.2016)
Pharmacological Group Nutritional supplement
Pack size & Demanded Price 1x50ml, 1x100ml, 1x250ml, 1x500ml, 1x1000ml;
Decontrolled
Me-too status Pam-E-Sel suspension of M/s Pameer Pharma
GMP status Inspection conducted on 26-10-2017 showed no
observation as reported by QA.
Division to conduct GMP inspection of Firm on priority.
Registration Board directed the firm to submit details of
target species for applied formulation (M-277).
Deferred for evidence of applied formulation/drug
along with registration number, brand name and name of
firm (M-286).
Evaluation by PEC The firm has revised formulation as per me-too reference
alongwith submission of fee of Rs. 20,000/- (deposit Slip
# 1959373) dated 28-11-2019.
Each Litre contains:
Vitamin E acetate…………………..200,000mg
Selenium (as sodium Selenite)……...2000mg
Zinc as sulphate……………..............9000mg
Me-too reference : SEL-E Oral solution of M/s Noble
Pharma (Reg # 063641)
Zixx suspension is intended to be used in poultry.
Decision: Rejected as firm has changed composition by removing one ingredient.

1818. Name and address of manufacturer / M/s Izfaar Pharmaceutical Pvt Ltd. 542-A & B, Sundar
Applicant Industrial Estate, Lahore, Pakistan
Brand Name +Dosage Form + Strength Doxysin-C Powder
Doxycycline Hyclate……………500mg
Tylosin Tartarate………………100mg
Colistin Sulfate……………….30mg
Type of Form Form-5
Pack size & Demanded Price 50gm, 100gm, 250gm, 500gm, 1000gm, 2.5kg, 5kg
10Kg, Decontrolled
Me-too status Doxy-Tol Powder by Lead Pharmaceuticals (Not
Confirmed)
GMP status New Section Veterinary Powder (General & General
Antibiotic)
Previous remarks of the Evaluator. Me-too status could not be confirmed.
firm (M-286).
Deferred for submission of remaining fee of Rs. 15,000/-
for revision of formulation (M-292).
Evaluation by PEC The firm has submitted Form-5 with revised strength of
applied formulation as follows:
Each gm contains:
Doxycycline Hyclate…….…200mg
Tylosin Tartarate……………100mg
Colistin Sulfate…………..…30mg
Me-too reference of “Doxi-Tol Powder of M/s. Leads
pharma (Reg# 057053)” has been verified.
Fee challan of Rs. 5000/- (Deposit slip#0792018) dated
06-08-2019 has been submitted. The firm has submitted
differential fee of PKR 15000/- (deposit slip # 1998744)
dated 14-01-2020.
1819. Name and address of manufacturer / M/s. A & K Pharmaceutical, 94-A, Punjab Small
Applicant Industrial Estate, Sargodha Road, Faisalabad
Brand Name +Dosage Form + Strength Akacin 50 Injection
Oxytetracycline hydrochloride………………..50mg
Diary No. Date of R& I & fee Dy. No. 373 dated 8-10-2015, 20,000/-, 18-09-2015
Type of Form Form-5
Pack size & Demanded Price 100ml; Decontrolled
Me-too status Santracycline -50 Injection of Sanna Labs
(Reg#027419)
GMP status Copy of Panel inspection dated 09-11-2018 recommends
renewal of DML except in oral powder penicillin section.
Previous decision(s) Deferred for confirmation of composition of applied
formulation whether quantity of API is in gm or mg (M-
292).
Deferred for submission of fee of Rs. 20,000/- for
revision of formulation (M-293)

Evaluation by PEC The firm has provided liquid injectable (vial) section.
The firm has submitted that we have applied quantity of
API in mg as per me-too reference. It is a typographic
error and written as grams therefore may be corrected
accordingly.
The firm has submitted fee challan of PKR 20,000/-
(desposit slip # 1908602) dated 02-07-2020.
Decision: Approved.
1820. Name and address of manufacturer / M/s Prix Pharmaceutica (Pvt) Ltd. Plot # 5 Pharmacity,
Applicant 30-Km, Multan Road, Lahore.
Brand Name +Dosage Form + Strength Pri-Metaforce Injection
Composition Each 100ml injection contains:-
L-carnitine HCl………………613.3mg
Thioctic Acid…………………20mg
Pyridoxine HCl………….……..15mg
Cyanocobalamine……………..3.0mg
D, L Acetylmethionine………….2000mg
L-Arginine…………………….240mg
L-Ornithine HCl……….………153.2mg
L-Citrulline……………………..120.0mg
L-Lysine HCl………..…………..62.5mg
Glycine………………………….150.0mg
Taurine………………………….150.0mg
Aspartic Acid…………………..150.0mg
Glutamic Acid………………….150.0mg
Fructose………………………..5,000mg
Sorbitol………………………….8,000mg
Diary No. Date of R& I & fee Dy. No.1132, 22-10-2012, Rs. 8000/-, 22-10-2012, Rs.
12000/-, 22-10-2012
Pharmacological Group Amino acids & sugar
Pack size & Demanded Price 50ml /Decontrolled
Me-too status Not confirmed
GMP status Panel inspection conducted on 16-12-2018
recommended for renewal of DML.
Previous decision(s) Deferred for confirmation of me-too status (M-257).
Evaluation by PEC The firm has submitted me-too reference “Metabolase
Injectable solution” of M/s Fatro Italy (Reg#019904) has
been verified while composition was verified from
marketed pack.
1821. Name and address of manufacturer / M/s Mylab Pvt Ltd., Khankah Sharif, Bahawalpur
Applicant
Brand Name +Dosage Form + Strength Tetramide Spray
Chlortetracycline……………..367000IU
Sulphanilamide…………….…5.963mg
Diary No. Date of R& I & fee Dy.No 2024 dated 16-01-2018 Rs. 20,000 Dated 15-01-
2018
Pharmacological Group Insecticide/hormonal analogue
Type of Form Form-5
Finished product Specification In house
Pack size & Demanded Price 210 ml; Decontrolled
Me-too status Orospray External Spray (Reg # 027453)

GMP status Panel inspection conducted on 13-09-2018 to 14-09-2018
recommends renewal of DML and grant of additional
sections.
Previous remarks of the Evaluator.  The firm has provided Aerosol vet section.
Previous decision(s) Deferred for clarification of manufacturing of powder
formulation in aerosol section (M-288).
Evaluation by PEC The firm has submitted that finished product aerosol
spray is not in powder form rather it is in liquid form. QC
procedures are carried out by taking weight of contents
of finished product because after filling liquid and
propellant sealing is performed and after that container
cannot be opened. Hence final filled volume is quantified
by weight.
Decision: Deferred for further deliberation regarding clarification of manufacturing of powder
formulation in aerosol section.
Applicant
Brand Name +Dosage Form + Strength Roximax Topical Spray
Composition Each 170 gm Bottle Contains:
Rifaximin…………….0.5gm
2018
Type of Form Form-5
Pack size & Demanded Price 170gm; Decontrolled
Me-too status Fatroximin Topical Spray (Reg#021263)
sections.
by weight.
Applicant
Brand Name +Dosage Form + Strength Anti-Mastitis Spray
Rifaximin………….…….0.100gm
Cefacetrile Sodium…..…0.200gm
Diary No. Date of R& I & fee Dy.No 2006, 16-01-2018 Rs. 20,000, 15-01-2018
Pharmacological Group Anti-Mastitis
Type of Form Form-5
Pack size & Demanded Price 4×15gm can; Decontrolled
Me-too status Cefaximin-l Anti Mastitis Spray (Reg # 019906)
sections.
by weight.
Applicant
Brand Name +Dosage Form + Strength Alspray
Aluminium Powder…………….40mg
Diary No. Date of R& I & fee Dy. No. 2005, 16-01-2018 Rs. 20,000 dated 15-01-2018
Pharmacological Group Antiseptic
Type of Form Form-5
Pack size & Demanded Price 210 ml; Decontrolled
Me-too status Aluspray Pressurized suspension (Reg # 028560)
sections.
by weight.
Applicant
Brand Name +Dosage Form + Strength Roximax Intrauterine Foam
Composition Each 13.4gm Bottle Contains:
Rifaximin………..0.10gm
2018
Type of Form Form-5
Pack size & Demanded Price 13.4g; Decontrolled
Me-too status Fatroximin Intrauterine Foam. (Reg#048129)
sections.

by weight.

a. Deferred Cases (Human)
1826. Name and address of Applicant M/s Zhangjiakou Dongfang Pharmaceutical Co., Ltd,
Address: Office # D-2, 2nd Floor, West Land Trade
Centre, Plot # C-5, Block 7/8, KCHSU, Shaheed-e-Millat
Road, Karachi
Detail of Drug Sale License Address: D-2, 2nd Floor West Land Trade Centre , Plot C-
5, Block 7/8, KCHSU, Shaheed e Millat Road, karachi
Validity: 09-10-202
Status: License to Sell by way of wholesale
Name and address of manufacturer M/s Shijiazhuang No. 4, Pharmaceutical Co., Ltd.
Address: No.288, Zhujiang Road, High Tech Industrial
Development Zone, Shijiazhuang, China
Name and address of marketing M/s Shijiazhuang No. 4, Pharmaceutical Co., Ltd.,
authorization holder Address: No.288, Zhujiang Road, High Tech Industrial
Development Zone, Shijiazhuang, China
Name of exporting country People’s Republic of China
Fee including differential fee Rs.100,000/- Dated 21-05-2019
Brand Name +Dosage Form + Strength Azofan 250mg dispersible tablet
Composition Each dispersible tablet Contains:

Azithromycin ………….250 mg
Finished Product Specification Manufacturer Specifications
Shelf life -----------
Pack size As per SRO
International availability Could not be confirmed
Detail of certificates attached Original legalized free sale certificate confirms GMP of
them manufacturer.
Certifying authority: Hebei Food and Drug
Administration, No. 391 Honggi Street, Shijiazhuang,
P.R. of China
The certificate remains valid till 21-02-2021.
Letter of authorization:
Letter of authorization showing M/s Zhangjiakou
Dongfang Pharmaceutical Co., Ltd as a sales agent in
Pakistan for this product has been submitted.
Remarks of the Evaluator The firm has submitted 6 months accelerated and 24
months real time Stability study data for following 3
batches as per Zone IV-A conditions.

350501
350502
350503
regulatory authority is required.
Original letter of authorization / sole agency agreement
with product licence holder/ marketing authorization
holder is required.
Original, legalized CoPP / GMP certificate and free sale
certificate are required.
The status of product license holder is required to be
mentioned.
Drug sale license not provided.
Previous Decision: Deferred for following observations (M-295)
reference regulatory authority.
Original letter of authorization / sole agency agreement
with product licence holder/ marketing authorization
holder is required.
Original, legalized CoPP / GMP certificate and free sale
certificate are required.
The status of product license holder.
Copy of Drug sale license is required.
Evaluation by PEC Letter of authorization has been submitted.
Original, legalized free sale certificate stating GMP
status of the manufacturer.
The product license holder and manufacturer are same.
1827. Name and address of Applicant “M/s RG Pharmaceutica Pvt Ltd.
Progressive square No. 703, P.E.C.H.S., Block -6, Shahra-
e-Faisal, Karachi”
Detail of Drug Sale License Address: Progressive square No. 703, P.E.C.H.S., Block -
6, Shahra-e-Faisal, Karachi
Validity: 17-01-202
Status: License to Sell by way of wholesale
Name and address of manufacturer M/s Livzon (Group) Pharmaceutical Factory
Address: No.38, Chuagye Road North, Jinwan District,
Zhuhai, Guangdong, P.R. China
Name and address of marketing M/s Livzon (Group) Pharmaceutical Factory
authorization holder Address: No.38, Chuagye Road North, Jinwan District,
Zhuhai, Guangdong, P.R. China
Name of exporting country China
Diary No. & Date of R& I Dy. No. 402, 12-12-2013,
Fee including differential fee Rs.100,000/- Dated 12-12-2013
Brand Name +Dosage Form + Strength Maclovir Tablet 125mg
Famciclovir……….….125mg
Finished Product Specification Manufacturer Specifications
ATC code: J05AB09
Shelf life -----------
Demanded Price 899
Pack size 6’s

International availability Famciclovir 125mg film coated tablet by M/s Actavis
(MHRA approved)
Detail of certificates attached Original Legalized COPP submitted with following
details:
Certificate No. 20190013
Issued by: Medical products administration of Guangdong
Province, West Tower, Tianyu Building No.753,
Dongfeng Road Est Guangzhou, Guangdong Province,
China
Free sale status: COPP confirms free sale status in the
exporting country.
The certificate remains valid till 28-05-2020.
Letter of authorization:
The firm has submitted copy of distribution agreement
between M/s RG Pharmaceutica (Pvt.) Ltd., Karachi and
M/s Livzon Pharmaceutical Group Inc. China. It was
valid till 21st January, 2018.
Previous Decision: Deferred for confirmation of me-too status (M-259).
Evaluation by PEC The firm has submitted that me-too for this formulation is
not available. The firm has submitted clinical justification
for applied formulation.
Decision: Approved as per policy for inspection of manufacturer abroad. Applicant will submit
valid COPP and sole agency agreement as expired during processing of case.
a. Verification of stability study data
Sr. Name & Address of Brand Name Type of Form, International Availability
No. Manufacturer / (Proprietary Name + Dosage Initial Diary & / Local Availability
Applicant Form + Strength), Date, Fee
Composition, (including GMP Inspection Report
Pharmacological Group, differential fee), Date & Remarks
Finished Product Demanded Price /
Specification Pack size
1828. M/s PharmEvo (Pvt.) DAPLOS 5mg Tablet Form 5-D Farxiga Tablets by
Limited, A-29, North Duplicate, Astrazaneca USFDA
Western Industrial Each Film coated tablet Rs. 50,000/-
Zone, Port Qasim, contains: 12-06-2015
Karachi. Dapagliflozin as propanediol As per P.R.C GMP inspection dated
monohydrate………….5mg 23-02-2018 showed that
the firm was considered
Anti-diabetic to be operating at an
acceptable level of
In-house specifications compliance with GMP
standards.
1829. M/s PharmEvo (Pvt.) DAPLOS 10mg Tablet Form 5-D Farxiga Tablets by
Limited, A-29, North Duplicate, Astrazaneca USFDA
Western Industrial Each Film coated tablet Rs. 50,000/-
Zone, Port Qasim, contains: 12-06-2015
Karachi. Dapagliflozin as propanediol As per P.R.C
monohydrate…….10mg GMP inspection dated
23-02-2018 showed that
Anti-diabetic the firm was considered
to be operating at an
In-house specifications acceptable level of
compliance with GMP
standards.
Drug DAPLOS 5mg Tablet
DAPLOS 10mg Tablet
Name of Manufacturer M/s PharmEvo (Pvt) Limited, A-29, North Western Industrial Zone, Port
Qasim, Karachi.
Manufacturer of API M/s Jiangsu Yongan Pharmaceutical Co, Ltd, China
API Lot No. DGF-201804001
Description of Pack
Alu Alu Foil printed in Unit carton
Accelerated: 40°C ± 2°C/ 75% ± 5% RH
Frequency Accelerated : 0 , 3, 6 (months)
Real Time: 0 , 3, 6 (Months)
Products applied Batch No. Batch Size Manufacturing Date
DAPLOS 5mg Tablet 18PD-2389-05-T 2500 Tablet 08-2018
18PD-2390-06-T 2500 Tablet 08-2018
18PD-2391-07-T 2500 Tablet 09-2018
DAPLOS 10mg Tablet 18PD-2409-06-T 2500 Tablet 08-2018
18PD-2410-07-T 2500 Tablet 08-2018
18PD-2411-08-T 2500 Tablet 09-2018
No. of Batches 03
Date of Submission 4155 (22/04/2019)
4993 (02/05/2019)
No.
1. COA of API Copy of COA (Batch # DGF-201804001) from M/s
Jiangsu Yongan Pharmaceutical Co, Ltd, China is
submitted.
2. Approval of API by regulatory authority of The firm has submitted copy of GMP certificate of
country of origin or GMP certificate of API M/s Jiangsu Yongan Pharmaceutical Co, Ltd, China
manufacturer issued by regulatory authority of issued by China Food and Drug Administration. The
country of origin. certificate is valid till 03-03-2021.
Yes
respective documents like chromatograms, Yes
5. Documents confirming import of API etc. The firm has submitted commercial invoice for the
purchase of Dapagliflozin propanediol monohydrate
(700 g) attested by ADC DRAP, Karachi dated 26-
06-2018.

/ documents.
Yes
Yes
Rules, 1978.
The firm has submitted 6 months accelerated and 6 months real time stability data of three batches.
Shortcomings communicated Response of the firm

Justify the dissolution specifications NLT 75% in The firm has submitted that after thoroughly
30 min since the dissolution specifications of FDA reviewing literature we found that Dapagliflozin
approved product (FARXIGA Tablet) is NLT Q in product is in BCS Class 1 so we have revised our
15 min. current specifications as NLT 85% in 15 min.
(The value of Q has been defined by FDA as well We have performed 9 months stability sample kept
as USP general chapter is 75% to 80%). for long term stability on this revised specification
and dissolution results showed more than 85% in
15 minutes. The firm has submitted revised
specifications with method of analysis and 9
months dissolution test report.
Previous Decision: Deferred for following: (M-291)
Scientific justification how the stability study data at 9th month conducted as per revised dissolution
specification [ i.e. NLT 85% (Q=80%) in 15 minutes] with values close to acceptance criteria can be
representative of whole 6 months stability conducted at accelerated and real time conditions with dissolution
specifications different from innovator product [i.e. NLT 75% after 30 minutes].
Evaluation by PEC:
The firm has submitted that we would like to inform that we have now performed dissolution testing on one
batch of stability sample after 6 months of accelerated study of Daplos 5mg and 10mg Tablet on accelerated
conditions i.e., 40oC and 75% RH and results are found to be within specification limits.
Previous Decision: Registration Board decided to defer the case and directed the firm to submit dissolution
testing data with specifications of “NLT Q within 15 minutes” at initial and one month time point at both
accelerated and real time stability conditions for 2 batches (M-293).
Evaluation by PEC: The firm has submitted stability study data of initial and one month testing with revised
dissolution specifications including raw data sheets and chromatograms of following 2 new batches of
DAPLOS 5mg Tablet and DAPLOS 10mg Tablet.
Manufacturing
Strengths Batch No Batch size
date
DAPLOS 5mg Batch # 20PD-3138-08-T 2500 Tablets Feb-2020
Tablet Batch # 20PD-3139-09-T 2500 Tablets Feb-2020
DAPLOS 10mg 20PD-3140-10-T 2500 Tablets Feb-2020
Tablet 20PD-3141-11-T 2500 Tablets Feb-2020
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Daplos
(Dapagliflozin) 5mg and 10mg Tablets by M/S PharmEvo (Pvt.) Limited, A-29, North Western
Industrial Zone, Port Qasim , Karachi.
Reference No: F.1-2/2020-PEC dated 6th July, 2020

Investigation Date and Time: 02nd July, 2020
Investigation Site: Factory premises of M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial
Zone, Port Qasim, Karachi.
Background:
Chairman Registration Board considered the applications of M/s PharmEvo (Pvt.) Limited, A-29, North
Western Industrial Zone, Port Qasim , Karachi for registration of Daplos (Dapagliflozin) 5mg & Daplos
(Dapagliflozin) 10mg Tablets and constituted a three member panel to investigate the authenticity /
genuineness of data (import of raw material and stability data). Panel was advised to conduct inspection of the
firm and to submit report for further consideration.
4. Prof. Dr. Rafeeq Alam Khan, Dean. Faculty of Pharmacy, Ziauddin University,
Karachi (Member Registration Board).
5. Dr. Saif-ur-Rehman Khattak, Director/ FGA, CDL, Karachi.
6. Ms Sanam Kauser, Assistant Director, CDL, DRAP, Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability data), manufacturing
of stability batches and stability studies on these batches.

The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence physical
inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also
audited. The details of investigation may be summarized as under:
Q.
Question Observation by Panel
No.
1. Do you have documents confirming the The firm has imported Dapagliflozin 700g vide
import of Dapagliflozin API including Invoice No. ZY18060601G/W dated June 6, 2018
approval from DRAP? from M/s Jiangsu Yongan Pharmaceutical Co. Ltd.,
China for the manufacturing of lab scale batches of
Dapagliflozin 5mg and 10mg Tablets. The firm has
proper approval for the import of the API from
DRAP, Karachi.
2. What was the rationale behind selecting the The rationale behind selecting the particular source
particular manufacturer of API? of API is the laid down criteria of the firm in their
Vendor Evaluation procedure which include the
GMP status of the firm, DMF source and capability
to provide API reference standard and impurity
standard.
3. Do you have documents confirming the Firm has documents confirming the import of
import of Dapagliflozin, reference standard Dapagliflozin, The API working standard was
and impurity standards? imported at the time of import of the API.
4. Do you have certificate of Analysis of the The firm has certificates of analysis for API and
API, reference standards and impurity working standard of the API.
standards?
5. Do you have GMP certificate of API Firm has GMP certificate issued by the Huaian
manufacturer issued by regulatory Authority Market Supervision Administration, China.
of country of origin?
6. Do you use API manufacturer method of The firm has used API manufacturer method for
testing for testing API? testing the API.
7. Do you have stability studies reports on API? The firm has stability studies reports on API.
8. If yes, whether the stability testing has been The stability testing has been performed as per SIM
performed as per SIM method and method however, no degradation products are
degradation products have been quantified? reported by the manufacturer.
9. Do you have method for quantifying the The firm has API manufacturer method for
impurities in the API? quantifying the impurities in the API.

10. Do you have some remaining quantities of Firm has some quantities of the API and its working
the API, its reference standard and standard.
impurities standards?
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients
excipients? which includes Daplos 5mg Tablet, Super Tab
21AN (Lactose Anhydrous), Microcrystalline
cellulose PH.102, Crospovidone, Colloidal Silicon
Dioxide (Aerosil 200), Magnesium Stearate and
Opadry Yellow II 85G62338 has been used for
coating and Daplos 10mg Tablet, Super Tab 21AN
(Lactose Anhydrous), Microcrystalline cellulose
PH.102, Crospovidone, Colloidal Silicon Dioxide
(Aerosil 200), Magnesium Stearate and Opadry
White II 85G68918, Lake of Quinoline Green has
been used for coating.
12. Do you have documents confirming the The firm has necessary documents confirming the
import of the used excipients? import of the used excipients.
13. Do you have test reports and other records on The firm has test reports and other records on the
the excipients used? excipients used.
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Dapagliflozin 5mg and 10mg
Dapagliflozin 5mg and 10mg Tablets? Tablets.
15. Have you performed Drug- The firm has not performed Drug-excipient
excipient compatibility studies as the composition of their
compatibility studies? tablets is similar to that of the innovator product
(Forxiga Tablets 5mg and 10mg manufactured by
M/s Astrazeneca AB).
16. Have you performed comparative The firm has performed comparative dissolution
dissolution studies? profile of Daplos 5mg and 10mg Tablet with
Forxiga Tablets 5mg and 10mg manufactured by
M/s Astrazeneca AB respectively.
Similarity factor for Dapagliflozin 5mg Tablet are as
follows:
a. Buffer pH 1.2 (Drug releases more than
85% in 15minutes so no need to calculate
F2).
b. Acetate Buffer (Drug releases more than
F2).
c. Phosphate Buffer (Drug releases more than
F2).
Similarity factor for Dapagliflozin 10mg Tablet are
as follows:
a. Buffer pH 1.2 (Drug releases more than 85% in
15minutes so no need to calculate F2).
b. Acetate Buffer (Drug releases more than 85%
in 15minutes so no need to calculate F2).
c. Phosphate Buffer (Drug releases more than
85% in 15minutes so no need to calculate F2).

17. Do you have product development (R&D) The firm has dedicated R&D section with
section? reasonable facilities of equipment, human resource
and utilities.
18. Do you have necessary equipment available The firm has all necessary equipment related to
in product development section for manufacturing available in R&D section for
development of Dapagliflozin 5mg & 10mg manufacturing of Dapagliflozin 5mg and 10 mg
Tablets? Tablets. The quality control related to development
work has been done in the routine quality control
laboratory; however, there are dedicated HPLCs and
Human Resource for this purpose.
19. Are the equipment in product development All the equipment used in product development are
section qualified? qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration/ re-
Calibration / re-qualification program for the qualification program for the equipment used in
equipment used in PD section? PD section.
21. Do you have qualified staff in product The firm has 05 pharmacists and 01 chemist in
development section with proper manufacturing section of product development with
knowledge and training in product suitable knowledge and training in product
development? development. 02 QC Analysts are dedicated for new
products testing.
22. Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies of for the stability studies of:
Dapagliflozin 5mg and 10mg Tablets as Dapagliflozin 10mg Tablets with Batch Numbers:
required? 18PD-2409-06-T
18PD-2410-07-T
18PD-2411-08-T
Dapagliflozin 5mg Tablets with Batch Numbers:
18PD-2389-05-T
18PD-2390-06-T
18PD-2391-07-T
Further, as per decision of Board in 293 DRB held
on 6 – 8 January, 2020, firm has manufactured two
fresh batches each for both strength of Dapagliflozin
5mg and 10mg Tablets.
20PD-3140-10-T
20PD-3141-11-T
20PD-3138-08-T
20PD-3139-09-T
All batches have been produced with batch size of
2500 tablets.
23. Do you have any criteria for fixing the batch The criteria for fixing batch size is according to
size of stability batches? DRAP guidelines
24. Do you have complete record of production The firm has complete record of production of
of stability batches? stability batches.
25. Do you have protocols for stability testing of The firm has detailed protocols for stability testing
stability batches? of stability batches.
26. Do you have developed and validated the The firm has developed and validated stability
method for testing of stability batches? indicating method for testing of their finished
product supported by forced degradation studies.

27. Do you have method transfer studies in Method transfer studies have not been done,
case when the method of testing being however, validation of the method has been
used by your firm is given by any other lab? performed.
28. Do you have documents confirming the The firm has documents confirming the installation
qualification of equipments / instruments and operational qualification of the equipment /
being used in the test and analysis of instruments being used in the test and analysis of
Dapagliflozin and the finished drug? Dapagliflozin and the finished drug.
29. Do your method of analysis stability The firm’s method of testing is stability indicating
indicating? as supported by forced degradation studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per
Compliant? record available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports are available.
Dapagliflozin testing?
32. Do you have some remaining quantities of The firm has remaining quantities of the stability
degradation products and stability batches? batches kept in stability chambers.
33. Do you have stability batches kept on The firm has kept all the three batches on real
stability testing? time and accelerated stability testing. Accelerated
stability testing is over whereas in real time studies
12 months testing have been completed with
satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the
Equipment used in Dapagliflozin 5mg & equipment used in Dapagliflozin tablets production
10mg tablets production and analysis? and analysis.
35. Do proper and continuous monitoring and The firm has 16 stability chambers, 02 for
control are available for stability chamber? accelerated and 14 for real time stability testing. All
the chambers are properly qualified. All the
chambers are provided with continuous power
supply and data loggers for continuous monitoring.
36. Do related manufacturing area, equipment, The firm has manufacturing area provided with
personnel and utilities be rated as GMP necessary qualified equipment and utilities. The
compliant? manufacturing personnel are suitable in number and
qualification to run the manufacturing processes as
per GMP requirements. The environmental
conditions and their controls are also proper. The
overall GMP conditions can be rated as compliant.
37. Specific Queries by PEC/Board

To verify and report the submitted stability As per direction of the PEC, stability data of Daplos
study data of 2 batches of Daplos 5mg and 5mg tablets and Daplos 10mg tablets with following
10mg Tablets each. details were checked.
1. Daplos 5mg tablets:
B.No. 20PD3138-08-T (2500 tablets) and
B.No. 20PD3139-09-T (2500 tablets).
2. Daplos 10mg tablets:

B. No. 20PD-3140-10-T (2500 tablets) and
B. No. 20PD-3141-11-T (2500 tablets).
The stability data for all these batches at 0 month
and 1 month is satisfactory.
Conclusions:
3. On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Daplos (Dapagliflozin) 5mg and 10mg Tablets is verifiable to satisfactory level.
4. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well suited
for the manufacturing of Dapagliflozin 5mg and 10mg Tablets.
Recommendations:
The firm may kindly be granted necessary registration of Dapagliflozin 5mg and 10mg Tablets.
Decision: Registration Board decided to approve registration of Daplos 5mg and 10mg Tablets with
Innovator’s specifications by M/s PharmEvo (Pvt.) Limited, A-29, North Western Industrial Zone, Port
Qasim, Karachi. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months. Board further decided that
verification of fee challan may be done as per decision of 285th meeting of Registration Board.
Sr. No. Name & Address of Brand Name Type of Form, International
Manufacturer / (Proprietary Name + Initial Diary & Date, Availability / Local
Applicant Dosage Form + Fee (including Availability
Strength), Composition, differential fee),
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date
Finished Product
Specification
1830. M/s Neutro Pharma Sinacalcet 30mg Tablet Form 5 USFDA approved
(Pvt.) Ltd. 9.5 km Dy. No.6882 dated
Sheikhupura Road Each film coated tablet 22-02-2018
Lahore. contains: Rs. 20,000/- dated
Cinacalcet as 21-02-2018, GMP inspection dated
hydrochloride……30mg 14’s, 28’s, 30’s, 84’s; 18-07-2017 showed
As per SRO that the firm has
Anti-parathyroid maintained fair level of
compliance with GMP.
Manufacturer’s
Manufacturer’s
Manufacturer’s
Drug Sinacalcet 30mg Tablet
Sinacalcet 60mg Tablet
Sinacalcet 90mg Tablet
Name of Manufacturer M/s Neutro Pharma (Pvt.) Ltd. 9.5 km Sheikhupura Road Lahore.
Manufacturer of API M/s Fuan Pharmaceutical (Group) Co., Ltd, China

API Lot No. L-1703180301
Description of Pack Blistered as 10’s × 3 packed in unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C/75%±5% RH
Real Time: 30°C ± 2°C/75%±5% RH
Time Period Accelerated: 6 months
Real Time: 6 months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,1,2,3,4& 6 (months)
Products applied Batch No. Batch size Manufacturing date
Sinacalcet 30mg Tablet SIN-FC-30-001-18 240 + 280 Tablets 09/2018
SIN-FC-30-002-18 240 + 280 Tablets 11/2018
SIN-FC-30-003-18 240 + 280 Tablets 11/2018
SIN-FC-60-002-18 240 + 280 Tablets 11/2018
SIN-FC-60-003-18 240 + 280 Tablets 11/2018
SIN-FC-90-002-18 240 + 280 Tablets 11/2018
SIN-FC-90-003-18 240 + 280 Tablets 11/2018
No. of Batches 03
Date of Submission 17698 (17-09-2019)
17698 (17-09-2019)
22419 (30-10-2019)
No.
1. COA of API. Copy of COA (Batch #L-1703180301) from M/s
Fuan Pharmaceutical (Group) Co., Ltd, China is
submitted.
2. Approval of API by regulatory authority of Copy of GMP certificate issued by Chongqing
country of origin or GMP certificate of API Daguan Economic Development Area Management
manufacturer issued by regulatory authority of Committee. It is valid until 03/03/2020.
country of origin.
5. Documents confirming import of API etc. The firm has submitted copy of commercial invoice
for the purchase of Cinacalcet HCl (2Kg), attested
by ADC DRAP, Lahore dated 18-07-2018.
sign and stamp) for ensuring authenticity of data
/ documents.
7. Commitment to continue real time stability study Yes
till assigned shelf life of the product.
Rules, 1978.

● The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data for 03 Batches.
Sr.
Observations Response of the firm
No.
1. GMP certificate from concerned The firm submitted GMP certificate of API
regulatory authority is required to be manufacturer with new name i.e., M/s Fuan
submitted. Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co., Ltd, China. However,
certificate of analysis submitted was of previous
API manufacturer. Similarly, name and address
of API manufacturer mentioned on invoice
cleared by AD (I&E), Lahore was of different
name.
Certificate of Analysis: M/s. Fuan
Pharmaceutical (Group), Co. Ltd., No.1, Huanan
Yi Road, Changhsou District, Chongqing
401254, P.R. China.
GMP certificate: M/s Fuan Pharmaceutical
Group Chongqing Bosen Pharmaceutical Co.,
Ltd., No. 1, Huanan Yi Road, Changshou
District, Chongqing 401254, China.
Invoice: M/s Fuan Group Chongqing Kingsday
Pharmaceutical Co Ltd., No. 2, Huangyang
Road, Yubei District, 401120, China.
2. Finished product specifications alongwith Submitted
details of analytical methods are required
to be submitted.
3. Justification of dissolution limits of NLT The firm revised dissolution limit to 80% (Q)
75% is required. Moreover, details of with following dissolution test conditions:
analytical procedures of dissolution and Dissolution medium: 0.01N HCl
assay are required. Time: 45min
Apparatus: Type II (Paddle apparatus)
Temperature: 36.5oC to 37.5oC
RPM: 75
4. Justification of using UV method for both The firm developed HPLC method for assay
assay and dissolution testing. determination during stability study. The firm
submitted following:
 Analytical method validation report
 Performance of assay test on HPLC at 9th
month and 12th month time points of
stability studies.
 Summary sheets, relevant
chromatograms and raw data sheets
were submitted.
Decision: Registration Board decided to reject the applications of Sinacalcet 30mg Tablet, Sinacalcet
60mg Tablet and Sinacalcet 90mg Tablet of M/s Neutro Pharma (Pvt.) Ltd. 9.5 km, Sheikhupura Road
Lahore due to following reasons:
 Firm has performed assay test of drug product on UV-Visible spectrophotometer although it was
required to be performed on HPLC method either as per innovator product or as per method of drug
substance manufacturer as evident from the details of COA of drug substance.
 Firm adopted non-validated HPLC method at 9-month testing point which cannot cover the
accelerated stability studies for the whole 6 months period and real time stability studies till 9th month
time point.
 Firm used testing method derived from literature for testing their product without performing
validation studies. At 9-month time point, the firm submitted that they have used validated HPLC
method for testing of stability batches. In actual, the firm submitted analytical method validation
report of “Assay by UV-visible spectrophotometer”.
b. Exemption from onsite verification of stability data
Sr. Name & Address of Brand Name Type of Form, International

No. Manufacturer / (Proprietary Name + Dosage Initial Diary & Date, Availability
Applicant Form + Strength), Fee (including
Composition, differential fee), GMP Inspection
Pharmacological Group, Demanded Price / Report Date &
Finished Product Pack size Remarks
Specification
1833. M/s Kaizen Prucal Tablet 1mg Form-5D Motegrity Tablets
Pharmaceuticals (Pvt) Each Film Coated Tablet Dy.No 4630 (USFDA Approved)
Ltd. Contains: 08-02-2018 Rs.50,000
E-127-129, North Prucalopride (as 26-01-2018 02-07-2019
Western Industrial succinate).….1mg As per SRO Satisfactory level of
Zone, Bin Qasim, Other drugs for constipation GMP compliance.
Karachi ATC code: A06AX05
1834. M/s Kaizen Prucal Tablet 2mg Form 5-D
Pharmaceuticals (Pvt) Each Film Coated Tablet Dy No. 20086
Ltd. Contains: 06-11-2017
E-127-129, North Prucalopride (as PKR 50,000/-
Western Industrial succinate)……2mg (31-10-2017)
Zone, Bin Qasim, Other drugs for constipation (Duplicate dossier
Karachi ATC code: A06AX05 verified from R&I)
As per SRO
Manufacturer of API Symed Labs Limited Sy No. 744, 745 & 751, Mandollagudem village,
Choutuppal Mandal, Yadadri District, Telangana India.
API Lot No. PCS 0010617
Description of Pack Alu-Alu blister
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Frequency Real Time: 0, 3 & 6 (months)
Accelerated: 0, 3 6 (months)
PRUCAL TABLET 1MG
Batch No. TF-01 TF-02 TF-03
PRUCAL TABLET 2MG
No. of Batches 03
Date of submission 30389 (15-01-2020)
Documents To Be Provided Status
COA of API Yes
Approval of API by regulatory authority of country of Firm has submitted GMP certificate issued by Drugs
origin or GMP certificate of API manufacturer issued Control Administration Government of Telangana.
by regulatory authority of country of origin. Copy of GMP certificate issued by DCA Telangana for
the M/s Symed Labs Limited, Unit-VI, Survey No. 744,
745, 750, 751, 752 & 753, Mandollaguden (Village),
Choutuppal (Mandal), Yadadri District, Telangana,
India and valid upto 10-2021 has been submitted.
Yes
respective documents like chromatograms, laboratory Yes
Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated
14-09-2017 specifying import of 15g API.
The invoice is not signed by AD (I&E) DRAP Karachi.
Firm has submitted copy of DHL invoice for the said
invoice.
and stamp) for ensuring authenticity of data / Yes
documents.
Yes
Yes
1978.
ADMINISTRATIVE PORTION
1. Reference of last onsite panel inspection for  Firm has referred to their last onsite inspection
instant dosage form conducted during last two conducted for product Rofair (Roflumilast) 500mcg
years. 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.
 Related manufacturing area, equipment, personnel
and utilities are GMP compliant.
2. Documents for the procurement of API with Firm has submitted copy of commercial invoice dated
approval from DRAP (in case of import). 14-09-2017 specifying import of 15g API.
The invoice is not signed by AD (I&E) DRAP
Karachi. Firm has submitted copy of DHL invoice for
the said invoice.

3. Documents for the procurement of reference Firm has submitted copy of invoice of purchase of
standard and impurity standards. working reference standard.
4. Approval of API/ DML/GMP certificate of API Firm has submitted GMP certificate issued by Drugs
manufacturer issued by regulatory authority of Control Administration Government of Telangana.
country of origin. Copy of GMP certificate issued by DCA
Telangana for the M/s Symed Labs Limited, Unit-
VI, Survey No. 744, 745, 750, 751, 752 & 753,
Mandollaguden (Village), Choutuppal (Mandal),
Yadadri District, Telangana, India and valid upto
10-2021 has been submitted.
5. Mechanism for Vendor pre-qualification Firm has submitted copy of SOPs for vendor pre-
qualification.
6. Certificate of analysis of the API, reference Firm has submitted COA of API, and working
standards and impurity standards standard.
7. Documents for the procurement of excipients Firm has submitted documents for procurement of
used in product development? excipients.
8. List of qualified staff involved in product Firm has provided list of technical staff of product
development with relevant experience. development section.
PRODUCTION DATA
9. Authorized Protocols/SOP for the development Firm has submitted SOPSs for product development.
& stability testing of trial batches.
10. Complete batch manufacturing record of three Firm has provided Batch Manufacturing Record for all
stability batches. the three batches of each strength.
11. Record of remaining quantities of stability Firm has provided following remaining quantities for
batches. each batch:
PRUCAL TABLET 1MG
TF-01: 730 Tablets
TF-02: 213 Tablets
TF-03: 213 Tablets
PRUCAL TABLET 2MG

Trial # 01: 725 Tablets
QA/QC DATA
12. Record of Digital data logger for temperature and Firm has submitted record of Digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated) chambers.
13. Method used for analysis of API along with Firm has submitted COA and method of analysis of
COA. API.
14. Method used for analysis of FPP & complete Firm has submitted method of analysis of FPP and
record of testing of stability batches (i.e. complete record of testing of stability batches along
chromatograms, lab reports, raw data sheets etc.) with chromatograms
15. Reports of stability studies of API from Firm has submitted both accelerated (40°C ± 2°C &
manufacturer. 75±5%RH) stability studies & long term (30°C ± 2°C
& 75±5%RH) stability studies reports of three batches
of API’s. The real time stability study data is till 60
months.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients
used.
17. Drug-excipients compatibility studies. Firm has submitted that they have used same
excipients in their formulation as used by the

innovator. Therefore drug-excipient compatibility
studies are not required.
18. Record of comparative dissolution data. Firm has submitted CDP data of their product against
the Resolor Tablet of Janssen. The drugs show more
than 85% release in 15 minutes at all media.
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports for HPLC
audit trail reports on product testing. analysis for all the three batches.
Evaluation by PEC:
Shortcomings communicated Response by the firm

The commercial invoice for import of API is of 28- We have procured API through invoice dated 14-09-
03-2017, while the manufacturing date of the API lot 2017 and the manufacturing date of those API batch
used in stability studies is June 2017. Justify how a was June 2017. We have also procured small
material which is manufactured in June 2017 can be quantity of API for trial batches and mistakenly
imported in March 2017. Further justify why the attached its commercial invoice. Firm has submitted
commercial invoice is not attested by AD (I&E) commercial invoice dated 14-9-2017. Firm has
DRAP field office. submitted that the material was procured 2 years
back and at that time we imported it through DHL
and have also submitted copy of DHL invoice.
Provide valid GMP certificate of API manufacturer Firm has submitted GMP certificate (No.
since the submitted certificate is expired. 2824/A3/2018) issued by Drugs Control
Administration Government of Telangana.
Copy of GMP certificate issued by DCA Telangana
for the M/s Symed Labs Limited, Unit-VI, Survey
No. 744, 745, 750, 751, 752 & 753, Mandollaguden
(Village), Choutuppal (Mandal), Yadadri District,
Telangana, India and valid upto 10-2021 has been
submitted.
As per the quality review report of innovator product, Prucalopride succinate lies in BCS class I so its
the particle size of API should be carefully controlled solubility and permeability is high, further we have
to develop a product having acceptable performance, used micronized API where the particle size was
justify your formulation development without controlled by API manufacturer. Due to intrinsic
controlling particle size. properties of API as well as controlled particle size
the drug dissolved more than 80% in 20 minutes.
Justify the dissolution specification NLT 75%(Q) We have selected dissolution specifications NLT
after 45 minutes, since the USFDA chemistry review 75%(Q) after 45 minutes based on recommendations
document of the innovator product specify of general chapter of USP and keeping in view the
dissolution specifications NLT (Q) at 20 minutes. immediate release nature of the drug product.
Comparative dissolution profile was also determined
which also show comparable results. CDP show
more than 80% relese in 20 minutes.
Now after reviewing the innovator product we have
revised our specifications to NLT 75%(Q) after 20
minutes as per the decision of 293rd meeting of
Registration Board.
Decision: Registration Board decided to defer the case for submission of COA, Form-3 and Form-7 for
import of API i.e., Prucalopride as succinate.
1835. Name and address of manufacturer / M/s Indus Pharma (Pvt.) Ltd. Plot No. 26,27 & 63-67,
Applicant Sector 27, Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Indazin 5mg Tablet
Dapagliflozin…5mg"
Diary No. Date of R& I & fee Dy. No 11495 dated 05-03-2019, Rs.20,000/- Dated
05-03-2019, 30,000/- dated 17-08-2020
Pharmacological Group SGLT2 Inhibitor
Type of Form Form-5

Pack size & Demanded Price As per DPC
Me-too status N/A
GMP status Firm has submitted copy of GMP inspection report
conducted on 16-08-2017 concluded acceptable level
of CGMP Compliance with Good manufacturing
practices
Remarks of the Evaluator Stability studies data as per directions of 278th meeting
is required.
Differential Fee of Rs. 30,000/- is required.
Previous Decision(s) Deferred for submission of stability data as per
directions of 278th meeting of Registration Board (M-
291).
Evaluation by PEC The firm has submitted stability study data alongwith
exemption data from onsite inspection.
Drug INDAZIN 5MG TABLET
Name of Manufacturer M/s Indus Pharma (Pvt.) Ltd. Plot No. 26,27 & 63-67, Sector 27, Korangi
Manufacturer of API M/s Lianyungang Jari pharmaceutical Co., Ltd. No.18, Zhenhua Road,
Lianyungang, China
API Lot No. 20170421
Description of Pack
Alu-Alu Blister
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,3,6 months
Real Time: 0,3,6 months
Batch No. TR-1/Dap 5mg TR-2/Dap 5mg Tab TR-3/Dap 5mg Tab
Tab
Batch Size 2500 tablets 2500 tablets 2500 tablets
No. of Batches 03
Date of Submission 11-05-2020 (Dy. No. 10545)
Certificate of analysis of API. Copy of COA of Dapagliflozin Propanediol
monohydrate (batch # 20170421) from M/s
Lianyungang Jari Pharmaceutical Co., Ltd. China is
submitted.
Approval of API by regulatory authority of country The firm has submitted copy of Manufacturing license
of origin or GMP certificate of API manufacturer of M/s Lianyungang Jari Pharmaceutical Co., Ltd.
issued by regulatory authority of country of origin. China issued by Jiangsu Food and Drug Administration,
China valid upto 31-12-2020.
Protocols followed for conduction of stability study Yes

Documents confirming import of API etc. The firm has submitted copy of commercial invoice for
the purchase of Dapagliflozin propanediol monohydrate
(0.175Kg), attested by Assistant Director (I & E)
DRAP, Karachi dated 20-06-2017 has been submitted.
documents.
Yes
Yes
1978.
 The firm has submitted 06 months Accelerated and 06 months Real Time Stability Data for 03 Batches.
The firm has requested for Exemption from On-site Investigation of their submitted stability data and provided
the following documents in conjunction with the checklist approved by the Registration Board in its 278th
Meeting:
Date of submission: 11-05-2020 (Dy. No. 10545)
1. Reference of last onsite panel inspection for Firm has referred to onsite inspection report of their
instant dosage form conducted during last two products “Canzin 100mg Tablet and Canzin 200mg
years. Tablet”, which were presented in 289th meeting of
Registration board. Registration Board decided to
approve registration of above products of M/s Indus
Pharma (Pvt) Ltd., Karachi.
Date of inspection : 14-03-2019
According to the report generated following points were
confirmed
a) HPLC Software is 21 CFR part 11 compliant where
all user levels were properly defined
b) The firm has stability chambers are equipped with
data loggers and centralized controlling software.
2. Documents for the procurement of API with The firm has submitted copy of commercial invoice for
approval from DRAP (in case of import). the purchase of Dapagliflozin propanediol monohydrate
(0.175Kg), attested by Assistant Director (I & E) DRAP,
Karachi dated 20-06-2017 has been submitted.
3. Documents for the procurement of reference
Not submitted.
standard and impurity standards.
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of Manufacturing license
API manufacturer issued by regulatory of M/s Lianyungang Jari Pharmaceutical Co., Ltd. China
authority of country of origin. issued by Jiangsu Food and Drug Administration, China
valid upto 31-12-2020.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for Evaluation of Vendors.
6. Certificate of analysis of the API, reference  The firm has submitted copy of COA of Dapagliflozin
standards and impurity standards Propanediol monohydrate (batch # 20170421) from
M/s Lianyungang Jari Pharmaceutical Co., Ltd. China
is submitted.

7. Documents for the procurement of excipients The firm has submitted documents for the procurement
used in product development? of excipients used in product development
development with relevant experience. in R&D department.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOP
development & stability testing of trial for Pharmaceutical Product Development”.
batches.
10. Complete batch manufacturing record of three The firm has submitted photocopy of Manufacturing
stability batches. protocols of following 03 Batches:
TR-1/Dap
2500 Tabs 04-2018
5mg Tab
TR-2/Dap
2500 Tabs 04-2018
5mg Tab
TR-3/Dap
2500 Tabs 04-2018
5mg Tab
batches. Trial No Batch Size Tablets Remaining
used for Quantities
stability of tablets
testing
TR-1/Dap
2500 Tabs 32 packs 116 packs
5mg Tab
TR-2/Dap
2500 Tabs 32 Packs 122 packs
5mg Tab
TR-3/Dap
2500 Tabs 32 packs 123 packs
5mg Tab
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for
temperature and humidity monitoring of chambers used in Real Time & Accelerated stability
stability chambers (real time and studies of applied product.
accelerated)
with COAs for Dapagliflozin propanediol monohydrate.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Testing Procedure for “Dapagliflozin 5mg Tablet” along
batches (i.e. chromatograms, lab reports, with Stability Study Reports.
15. Reports of stability studies of API from The firm has submitted 06 months accelerated and 24
manufacturer. months real time stability study data of three batches.
16. Analysis reports for excipients used. The firm has submitted analytical reports of excipients
used.
17. Drug-excipients compatibility studies. The firm has submitted that we used all the ingredients
same as used in innovator product Farxiga Tablet 5mg.
18. Record of comparative dissolution data. The firm has performed comparative dissolution study of
Dapagliflozin 5mg Tablet with Farxiga 5mg Tablet (Batch
# MV947) in three recommended mediums at pH 1.2, pH
4.5, pH 6.8. Dissolution profiles of both products were
considered similar.

19. Compliance Record of HPLC software The firm has submitted audit trail reports of applied
21CFR & audit trail reports on product product.
testing.
The firm has submitted 6 months accelerated and 6 months real time stability studies data of 3 batches.
Observations Response of the applicant

Documents for the procurement of reference The firm has submitted that we have imported
standard and impurity standards. reference standard alongwith API without invoice.
The API manufacturer of Dapagliflozin propanediol
monohydrate does not define any specific impurity
but define only unknown impurities in the analysis.
Analysis of indazin 5mg Tablet was done and found
no unknown impurity at accelerated and long term
storage conditions.
Justify dissolution specifications NLT 75% (Q) in The firm has submitted revised testing data with
20 min since dissolution specifications of innovator dissolution specifications NLT 85% in 15 min at
product Farxiga 5mg Tablet is NLT Q in 15min. initial and 3rd month time point at both accelerated
and real time stability conditions for 2 batches
alongwith raw data and chromatograms.
Certificate of analysis of reference standards and The firm has submitted copy of COA of working
impurity standards are required. standard of Dapagliflozin propanediol monohydrate.
Record of remaining quantities of stability batches The firm has submitted record of remaining quantities
i.e., Tablets used for stability testing and remaining of stability batches.
quantities of tablets are not mentioned in submitted
BPRs.
Decision: Registration Board decided to approve registration of INDAZIN 5mg Tablet with Innovator’s
specifications by M/s Indus Pharma (Pvt.) Ltd. Plot No. 26,27 & 63-67, Sector 27, Korangi Industrial
Area, Karachi. Manufacturer will place first three production batches on long term stability studies
1836. Name and address of manufacturer / M/s Scotmann pharmaceuticals, 5-D, I-10/3, Industrial
Applicant area, Islamabad
Brand Name +Dosage Form + Strength Vorscot Tablets 15mg
Vortioxetine hydrobromide eq. to
vortioxetine………………..15mg
Diary No. Date of R& I & fee 42031, -07-12-2018, Rs.50,000/- Dated 07-12-2018
Pharmacological Group Other Antidepressants
Pack size & Demanded Price As per SRO;
1× 10’s, 3× 10’s, 6× 10’s & 9× 10’s
Approval status of product in Reference TRINTELLIX 15mg Tablet (USFDA approved)
Me-too status N/A
recommends grant of GMP certificate.
Drug Vorscot Tablets 15mg
Name of Manufacturer M/s Scotmann pharmaceuticals, 5-D, I-10/3, Industrial area, Islamabad
Manufacturer of API M/s Liangyungang Jari Pharmaceutical Co., Ltd, Jiangsu, China
Description of Pack
Alu-Alu Blister

Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,1,2,3,4,6 months
Batch No. T#01 T#02 T#03
No. of Batches 03
Date of Submission 24-02-2020 (Dy. No.2566)
Certificate of analysis of API. Copy of COA of Vortioxetine hydrobromide (batch #
20180203) from M/s Liangyungang Jari Pharmaceutical
Co., Ltd, Jiangsu, China is submitted.
In addition, COAs of following from API supplier has
been submitted.
Working standard
Oxide impurity
2,6 impurity
Approval of API by regulatory authority of country The firm has submitted copy of GMP Certificate for M/s
of origin or GMP certificate of API manufacturer Liangyungang Jari Pharmaceutical Co., Ltd, Jiangsu,
issued by regulatory authority of country of origin. China issued by Liangyungang Drug Administration
Yes
the purchase of Vortioxetine hydrobromide (500g)
attested by Assistant Director (I & E) DRAP, Islamabad
dated 16-05-2018.
The firm has submitted copy of invoice for the purchase
of following:
Vortioxetine HBr Working standard (1gm)
Oxide Impurity (Batch # VTF 20180101, 10mg)
2,6- Impurity (Batch # VT2620170101, 10mg)
documents.
Yes
Yes
1978.
the following documents in conjunction with the checklist approved by the Registration Board in its 278th
Meeting:
Date of submission: 24-02-2020 (Dy. No.2566)
instant dosage form conducted during last two product “DASCOT 60mg Tablet”, which was presented
years. in 278th meeting of Registration board.
According to the report, following points were
confirmed
a) The HPLC software is 21CFR Compliant.
b) Continuous monitoring and power supply are
available for stability chambers alongwith data loggers.
approval from DRAP (in case of import). the purchase of Vortioxetine hydrobromide (500g)
dated 16-05-2018.
3. Documents for the procurement of reference The firm has submitted copy of invoice for the purchase
standard and impurity standards. of following:
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate for M/s
API manufacturer issued by regulatory Liangyungang Jari Pharmaceutical Co., Ltd, Jiangsu,
authority of country of origin. China issued by Liangyungang Drug Administration
6. Certificate of analysis of the API, reference Copy of COA of Vortioxetine hydrobromide (batch #
standards and impurity standards 20180203) from M/s Liangyungang Jari Pharmaceutical
been submitted.
Working standard
Oxide impurity
2,6 impurity
7. Documents for the procurement of excipients The firm has submitted documents for the procurement
used in product development? of excipients used in product development
development with relevant experience. in R&D department.
Production Data
development & stability testing of trial for Pharmaceutical Product Development”.
batches.
10. Complete batch manufacturing record of three The firm has submitted photocopy of Manufacturing
stability batches. protocols of following 03 Batches:
T#01 1500 Tabs 06-2018
T#02 1500 Tabs 06-2018
T#03 1500 Tabs 06-2018
used for Quantities
of tablets

stability
testing
T#01 1500 Tabs 448 224

T#02 1500 Tabs 448 224
T#03 1500 Tabs 448 224
QA / QC DATA
12. Record of Digital data logger for Firm has submitted photocopies of data logger record for
temperature and humidity monitoring of chambers used in Real Time & Accelerated stability
stability chambers (real time and studies of applied product.
accelerated)
with COAs for Vortioxetine hydrobromide.
14. Method used for analysis of FPP & The firm has submitted photocopy of Finished Product
complete record of testing of stability Testing Procedure for “Vorscot Tablet 15mg” along with
batches (i.e. chromatograms, lab reports, Stability Study Reports.
manufacturer. months real time stability study data of three batches of
vortioxetine hydrobromide.
used.
17. Drug-excipients compatibility studies. The firm has justified Drug-Excipient compatibility
studies by giving references from Hand book of
excipients.
18. Record of comparative dissolution data. The firm has submitted that we claimed exemption from
CDP since reference product is not available in Pakistan.
testing.
Sr. Observations Response of the applicant

No.
1. GMP certificate issued to API manufacture The firm has submitted copy of GMP certificate
is of city administration. It is required to issued by China Food and Drug Administration,
submit GMP certificate from provincial or China. It was valid till 19-11-2019.
federal administration.
2. Confirmation of Polymorphic form of The firm has submitted revised COA from API
Vortioxetine HBr used in stability studies is manufacturer stating polymorphic Form B of
required. vortioxetine HBr. The confirmation of
polymorphic form was done by XRD technique.
3. Justify dissolution specifications NLT 85% The firm has revised dissolution specifications in
dissolved in 45 min since dissolution accordance with innovator i.e., NLT 85% of the
acceptance criteria for innovator product labeled amount of vortioxetine in 30min and will
(TRINTELLIX) is NLT Q in 30 min perform testing for remaining time points with
revised limits. Moreover, commercial batch will
also be tested as per innovator specifications.
4. You have not performed uniformity of The firm has performed uniformity of dosage
dosage unit by content uniformity (HPLC), unit by content uniformity (HPLC).
as recommended by the USP general chapter
<905> since contents of Votioxetine

hydrombromide in formulation are less than
25%.
Decision: Registration Board decided as follows:
 Accept the stability study data as the dissolution specifications fall within the definition of immediate
release drug product and approved registration of following drug with innovator’s specification,
wherein manufacturer will adopt the dissolution specifications i.e. NLT Q at 30 minutes for
commercial batches.
 Vorscot Tablets 15mg
Furthermore, manufacturer will place first three production batches on long term stability studies
1837. Name and address of manufacturer / M/s Scotmann pharmaceuticals, 5-D, I-10/3, Industrial area,
Applicant Islamabad
Brand Name +Dosage Form + Vorscot Tablets 5mg
Strength
Vortioxetine hydrobromide eq. to vortioxetine………..5mg
Diary No. Date of R& I & fee 42028, 07-12-2018, Rs.50,000/- dated 07-12-2018
Pharmacological Group Other Antidepressants
Pack size & Demanded Price As per SRO;
1× 10’s, 3× 10’s, 6× 10’s & 9× 10’s
Approval status of product in TRINTELLIX 5mg Tablet (USFDA approved)
Me-too status N/A
recommends grant of GMP certificate.
Drug Vorscot Tablets 5mg
Name of Manufacturer M/s Scotmann pharmaceuticals, 5-D, I-10/3, Industrial area, Islamabad
Manufacturer of API M/s Liangyungang Jari Pharmaceutical Co., Ltd, Jiangsu, China
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0,1,3,6 months
Batch No. T#01 T#02 T#03
No. of Batches 03
Date of Submission 24-02-2020 (Dy. No.2566)

Certificate of analysis of API. Copy of COA of Vortioxetine hydrobromide (batch #
20180203) from M/s Liangyungang Jari Pharmaceutical
been submitted.
Working standard
Oxide impurity
2,6 impurity
Approval of API by regulatory authority of country The firm has submitted copy of GMP Certificate for M/s
of origin or GMP certificate of API manufacturer Liangyungang Jari Pharmaceutical Co., Ltd, Jiangsu,
issued by regulatory authority of country of origin. China issued by Liangyungang Drug Administration
Yes
the purchase of Vortioxetine hydrobromide (500g)
dated 16-05-2018.
The firm has submitted copy of invoice for the purchase
of following:
documents.
Yes
Yes
1978.
the following documents in conjunction with the checklist approved by the Registration Board in its 278 th
Meeting:
Date of submission: 24-02-2020 (Dy. No.2566)
instant dosage form conducted during last product “DASCOT 60mg Tablet”, which was presented in
two years. 278th meeting of Registration board.
According to the report, following points were confirmed
a) The HPLC software is 21CFR Compliant.
b) Continuous monitoring and power supply are available
for stability chambers alongwith data loggers.
approval from DRAP (in case of import). the purchase of Vortioxetine hydrobromide (500g)
dated 16-05-2018.

3. Documents for the procurement of reference The firm has submitted copy of invoice for the purchase
standard and impurity standards. of following:
4. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate for M/s
API manufacturer issued by regulatory Liangyungang Jari Pharmaceutical Co., Ltd, Jiangsu,
authority of country of origin. China issued by Liangyungang Drug Administration valid
upto 11-04-2024.
6. Certificate of analysis of the API, reference Copy of COA of Vortioxetine hydrobromide (batch #
standards and impurity standards 20180203) from M/s Liangyungang Jari Pharmaceutical
been submitted.
Working standard
Oxide impurity
2,6 impurity
7. Documents for the procurement of The firm has submitted documents for the procurement of
excipients used in product development? excipients used in product development
8. List of qualified staff involved in product The firm has submitted List of qualified staff involved in
development with relevant experience. R&D department.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of “Protocols/SOP for
development & stability testing of trial Pharmaceutical Product Development”.
batches.
10. Complete batch manufacturing record of The firm has submitted photocopy of Manufacturing
three stability batches. protocols of following 03 Batches:
T#01 1500 Tabs 06-2018
T#02 1500 Tabs 06-2018
T#03 1500 Tabs 06-2018
used for Quantities
stability of tablets
testing
T#01 1500 Tabs 448 224
T#02 1500 Tabs 448 224
T#03 1500 Tabs 448 224
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger record
and humidity monitoring of stability for chambers used in Real Time & Accelerated stability
chambers (real time and accelerated) studies of applied product.
with COAs for Vortioxetine hydrobromide.
record of testing of stability batches (i.e. Testing Procedure for “Vorscot Tablet 15mg” along
chromatograms, lab reports, raw data sheets with Stability Study Reports.
etc.)

manufacturer. months real time stability study data of three batches of
vortioxetine hydrobromide.
used.
17. Drug-excipients compatibility studies. The firm has justified Drug-Excipient compatibility
studies by giving references from Hand book of
excipients.
18. Record of comparative dissolution data. The firm has submitted that we claimed exemption from
CDP since reference product is not available in Pakistan.
testing.
Sr. Observations Response of the applicant
No.
1. GMP certificate issued to API manufacture The firm has submitted copy of GMP certificate
is of city administration. It is required to issued by China Food and Drug Administration,
submit GMP certificate from provincial or China. It was valid till 19-11-2019.
federal administration.
2. Confirmation of Polymorphic form of The firm has submitted revised COA from API
Vortioxetine HBr used in stability studies is manufacturer stating polymorphic Form B of
required. vortioxetine HBr. The confirmation of
polymorphic form was done by XRD technique.
3. Justify dissolution specifications NLT 85% The firm has revised dissolution specifications in
dissolved in 45 min since dissolution accordance with innovator i.e., NLT 85% of the
acceptance criteria for innovator product labeled amount of vortioxetine in 30min and will
(TRINTELLIX) is NLT Q in 30 min perform testing for remaining time points with
revised limits. Moreover, commercial batch will
also be tested as per innovator specifications.
4. You have not performed uniformity of The firm has performed uniformity of dosage
dosage unit by content uniformity (HPLC), unit by content uniformity (HPLC).
as recommended by the USP general chapter
<905> since contents of Votioxetine
hydrombromide in formulation are less than
25%.
 Accept the stability study data as the dissolution specifications fall within the definition of immediate
release drug product and approved registration of following drug with innovator’s specification,
wherein manufacturer will adopt the dissolution specifications i.e. NLT Q at 30 minutes for
commercial batches.
 Vorscot Tablets 5mg
Furthermore, manufacturer will place first three production batches on long term stability studies
c. Exemption from onsite verification of stability data (Deferred cases)
Sr. No. Name & Address of Brand Name Type of Form, International Availability /
Manufacturer / (Proprietary Name + Initial Diary & Date, Local Availability
Applicant Dosage Form + Fee (including
Strength), differential fee), GMP Inspection Report Date
Composition, & Remarks
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
1838. M/s Pharmatec Tigrelor 90mg tablet Form- 5 Brilinta 90 mg film-coated
Pakistan (Pvt.) Dy.No.931 tablets of M/s AstraZeneca
Limited, D-86/A, Each film-coated tablet Dated: 22-12-2014 UK Limited (MHRA
S.I.T.E., Karachi. contains: Rs.50,000/- Approved) / Not applicable
Ticagrelor...90mg (17-12-2014)
2 x 10’s; as per SRO
(Platelet Aggregation Last GMP inspection was
Inhibitor) conducted on 12-12-2017 and
GMP certificate was issued
Innovator’s on 15-12-2017.
specifications
Drug Tigrelor 90mg tablet
Name of Manufacturer M/s Pharmatec Pakistan (Pvt.) Limited, D-86/A, S.I.T.E., Karachi.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd. China
API Lot No. RD-TG-201709061
Description of Pack Alu- Alu Blister
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5% RH
Frequency Accelerated: 0, 3, 6 (month)
Real Time: 0, 3, 6, 9, 12 (months)
Batch No. 17PD064TICT05 17PD081TICT06 17PD089TICT07
Manufacturing Date Nov-2017 Dec-2017 Dec-2017
No. of Batches 04
Sr. No. Documents To Be Provided Status
1. CoA of API Firm has submitted copy of COA of Ticagrelor
(Batch # RD-TG-201709061) from M/s Nantong
Chanyoo Pharmatech Co., Ltd., China.
2. Approval of API by regulatory authority of Copy of GMP certificate (certificate No.2017006)
country of origin or GMP certificate of API issued by Nantong Food & Drug Administration,
manufacturer issued by regulatory authority of China. It is valid until 07/09/2020.
country of origin.

5. Documents confirming import of API etc. The firm has submitted commercial invoice for the
import of Ticagrelor (5kg) from M/s. Nantong
Chanyoo Pharmatech Co., Ltd, China attested by
ADC DRAP, Karach dated 27-10-2017.
sign and stamp) for ensuring authenticity of data
/ documents.
7. Commitment to continue real time stability study Yes
Rules, 1978.
Firm has submitted 6 months accelerated and 12 months real time stability study data of four batches.
Date of submission: 02-07-2019 vide diary no. 10339
instant dosage form conducted during last two product “Apixa 2.5mg and 5mg (Apixaban) Tablets”,
years. which was presented in 289th meeting of Registration
board. Registration Board decided to approve
registration of above stated drug product of M/s.
Pharmatec Pakistan (Private) Ltd, Karachi.
Date of inspection: 30-04-2019
According to inspection report, following points were
confirmed.
 The firm has 21CFR compliant HPLC
software.
 The firm has audit trail reports available.
2. Documents for the procurement of API with The firm has submitted commercial invoice for the
approval from DRAP (in case of import). import of Ticagrelor (5kg) from M/s. Nantong
Chanyoo Pharmatech Co., Ltd, China attested by ADC
DRAP, Karach dated 27-10-2017.
3. Documents for the procurement of reference The firm has submitted COAs of following working
standard and impurity standards. standards & impurity Standards :
Ticagrelor working standard (B # WS201603001)
Ticagrelor working standard (B # WTG01-170401)
Impurity standards
TG16 WRS (B# WTG05-170401)
De-Ethoxyl of TG WRS (B# WTG06-170401)
4. Approval of API/ DML/GMP certificate of Copy of GMP certificate (certificate No.2017006)
API manufacturer issued by regulatory issued by Nantong Food & Drug Administration,
authority of country of origin. China. It is valid until 07/09/2020.
5. Mechanism for Vendor pre-qualification The firm has submitted SOP for evaluation of vendors.
6. Certificate of analysis of the API, reference Firm has submitted copy of COA of Ticagrelor (Batch
standards and impurity standards # RD-TG-201709061) from M/s Nantong Chanyoo
Pharmatech Co., Ltd., China.
used in product development? invoices/COAs of the excipients used in the
formulation of applied product
Production Data
development & stability testing of trial for the Development of Ticagrelor 90mg Tablet”.
batches.
17PD064TICT05 2500 Tablets 29-01-2018
17PD064TICT06 2500 Tablets 29-01-2018
17PD064TICT07 2500 Tablets 30-01-2018
batches. Trial No Total no. Tablets Remaining
of Tablets used for Quantities
stability
testing
17PD064TI 2500 1800 700 tablets
CT05 Tablets Tablets
17PD064TI 2500 2330 170 tablets
17PD064TI 2500 2330 170 tablets
QA / QC DATA
12. Record of Digital data logger for temperature Firm has submitted photocopies of data logger record
and humidity monitoring of stability chambers for chambers used in Real Time & Accelerated
(real time and accelerated) stability studies of applied product from 29-11-2017 to
COA. Specifications, Raw Material Testing Procedures
along with COA for Ticagrelor.
record of testing of stability batches (i.e. Testing Procedure for “Ticagrelor 90mg Tablet” along
chromatograms, lab reports, raw data sheets with Stability Study Reports.
etc.)
manufacturer. Accelerated and 24 months Long term Stability Study
Data of 03 Batches from M/s Nantong Chanyoo
Pharmatech Co., Ltd. China. The storage conditions
for real time stability data are 25±2oC/60±5%RH.
16. Analysis reports for excipients used. The firm has submitted photocopy of Analytical
reports of excipients used.
17. Drug-excipients compatibility studies. The compatibility of Ticagrelor 900mg (API) and
40mg Sodium lauryl sulphate (Excipient) was studied
by HPLC analytic techniques after storage of mixture
under accelerated conditions. HPLC analysis of these
mixtures has not shown any significant physical and
chemical instability. Hence the study concludes that
Ticagrelor and sodium lauryl sulphate are compatible.
18. Record of comparative dissolution data. The firm has performed comparative dissolution
profile at pH 1.2, pH 4.5, pH 6.8 between Ticagrelor
90mg tablet and Brilinta 90mg tablet. The results
suggest similarity factor (f2) > 50 and difference
factor (f1) < 15 in all three media.

19. Compliance Record of HPLC software 21CFR The firm has submitted audit trail reports of
& audit trail reports on product testing. “Ticagrelor 90mg Tablet” from.
Sr. Observations communicated Response by the applicant

No.
1. Digital data logger record does not cover Digital logger sheets which cover the duration
the duration of stability study data. stability study data.
Clarification is required.
2. Justification is required for preparation of The first batch exhibiting the batch number
four batches for the purpose of carrying out 17PD048TICT04, is the pre-formulation batch, the
stability studies. very initial batch developed at every step of
formulation development, this supports in making
decision. These steps include process feasibility
studies, formulation optimization and
manufacturing process.
3. Audit trail reports of only one date are Audit trail on the testing time point is submitted.
submitted. It is important to submit the audit
trail reports at all time points of stability
studies as well as comparative dissolution
study.
4. Polymorphic formof Ticagrelor API is The firm has submitted that polymorphic form-II
required to be submitted. was used and further stated that same form of
molecule is discussed in the patent of Astra
Zeneca. The form-II of Ticagrelor is confirmed by
the melting points & X-ray Diffraction.
Storage conditions under which stability studies were conducted are at 25oC±2oC/60%±5% RH.
Previous Decision: Deferred for submission of scientific justification for conducting API stability studies at
storage conditions of 25oC±2oC/60%±5% RH.
Evaluation by PEC: The firm has submitted that internationally API stability studies are conducted at 25oC±2
o
C/60%±5%RH because majority of API manufacturer supplies their product to international market. When we
receive APIs, we keep them in controlled temperature i.e., 25oC. When we manufacture our finished product with
these APIs, we use to conduct stability studies of our products according to our stability Zone i.e., Zone IVA.
Previous Decision: Registration Board deferred the case for submission of valid GMP certificate of M/s Nantong
Chanyoo, Jiangsu province, China, issued by relevant Provincial or state Regulatory authority since the Nantong
Food and Drug Administration is not the relevant provincial regulatory authority (M-293).
Response of the firm: Firm has submitted copy of “License for Drug production” issued by the Jiangsu Food and
Drug Administration in the name of M/s Nantong Chanyoo Pharmatech Co., Ltd., China with License number “S.
20160512” and valid upto 31-12-2020.
The above cited certificate has been verified from the following web link of National Medical Product
Administration of China:
http://app1.sfda.gov.cn/datasearchcnda/face3/base.jsp?tableId=34&tableName=TABLE34&title=%D2%A9%C6%
B7%C9%FA%B2%FA%C6%F3%D2%B5&bcId=152911762991938722993241728138 .
Deferred for following submissions (M-294):
 Submission of real term stability studies data of the product for atleast 1 year along with degradation
studies in the finished pharmaceutical product as per the decision of 290th meeting of Registration Board
since the firm has used API whose stability testing has not been done as per the conditions of Zone IV-A.
 Scientific justification for performance of drug excipient compatibility studies with only 1 excipient (i.e.
Sodium lauryl sulphate).

 Status whether form-II of Ticagrelor is confirmed by the melting points & X-ray Diffraction by M/s
Pharmatec or API manufacturer
Evaluation by PEC: The firm has submitted following:
 Stability study data of API as per Zone IV-A.
 Drug Excipient compatibility was conducted and assessed through HPLC. Binary mixtures of excipient
and drug substance at a ratio 1:1 ratio in the solid state were prepared. Results showed no
interference/degradant was detected with any of the excipient used.
 Crystalline Form-II of Ticagrelor is confirmed by melting points & X-Ray diffraction as per DMF of API
manufacturer.
Decision: Registration Board decided to approve registration of Tigrelor 90mg Tablet with Innovator’s
specifications by M/s Pharmatec Pakistan (Pvt.) Limited, D-86/A, S.I.T.E., Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life and on accelerated
Manufacturer / (Proprietary Name + Dosage Initial Diary & Availability
Applicant Form + Strength), Composition, Date, Fee (including
Pharmacological Group, differential fee), GMP Inspection
Finished Product Specification Demanded Price / Report Date &
Pack size Remarks
1839. M/s Kaizen Tofacit 5mg Tablet Form-5 XELJANZ 5 mg
Pharmaceuticals Each Film Coated tablet Contains: Dy. No. 34109: film-coated tablets
(Pvt) Ltd. Tofacitinib (as citrate) 15.10.2018 (USFDA
E-127-129, North ……………5mg PKR 20,000/-: Approved)
Western Industrial 04.08.2018
Zone, Bin Qasim, Selective immunosuppressants As per SRO 02-07-2019
Karachi ATC code: L04AA29 Satisfactory level of
GMP compliance.
Case history:
Decision of 290th meeting of Registration Board:
Deferred for evidence of approval of applied formulation in reference regulatory authorities / agencies
and generic / me-too status which were adopted by the Registration Board in its 275th meeting.
Now the firm has submitted the reference and generic evidence which is as under:
Reference status “XELJANZ 5 mg film-coated tablets (Pfizer Europe MA EEIG Boulevard de la Plaine
17 1050 Bruxelles Belgium”
Generic/me-too status “ Xeljanz Film Coated Tablet 5mg of M/s Pfizer”
Decision of 293rd meeting of Registration Board:
Deferred for further deliberation regarding stability data.
The stability data of 3 batches have been submitted by the firm

Manufacturer of API Kaifeng Pharmaceutical (Grp)Co. Ltd. No. 1 Yunan Street Kaifeng
API Lot No. KFX171203
Description of Pack Alu-Alu blister
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real Time: 6 Months
Frequency Real Time: 0, 3 & 6 (months)
Accelerated: 0, 3 6 (months)

Date of submission 4648 (16-03-2020)
COA of API Yes
Approval of API by regulatory authority of country of origin Firm has submitted GMP certificate (No.
or GMP certificate of API manufacturer issued by regulatory HA20150067) issued by CFDA China. The certificate
authority of country of origin. is valid till 16-11-2020.
Protocols followed for conduction of stability study and
Yes
details of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data Yes
sheets etc.
Documents confirming import of API etc. Firm has submitted copy of commercial invoice dated
15-10-2018 specifying import of 0.5g API.
Karachi. Firm has submitted copy of DHL invoice for
the said invoice having tracking number
783242202418.
All provided documents will be attested (name, sign and
Yes
stamp) for ensuring authenticity of data / documents.
Yes
Commitment to follow Drug Specification Rules, 1978. Yes
ADMINISTRATIVE PORTION
1. Reference of last onsite panel inspection for instant  Firm has referred to their last onsite inspection
dosage form conducted during last two years. conducted for product Rofair (Roflumilast)
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.
 Related manufacturing area, equipment,
personnel and utilities are GMP compliant.
2. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). dated 15-10-2018 specifying import of 0.5g API.
Karachi. Firm has submitted copy of DHL invoice
for the said invoice having tracking number
783242202418.
3. Documents for the procurement of reference Firm has submitted copy of invoice of purchase of
standard and impurity standards. working reference standard.
4. Approval of API/ DML/GMP certificate of API Firm has submitted GMP certificate (No.
manufacturer issued by regulatory authority of HA20150067) issued by CFDA China. The
country of origin. certificate is valid till 16-11-2020.
5. Mechanism for Vendor pre-qualification Firm has submitted copy of SOPs for vendor pre-
qualification.
6. Certificate of analysis of the API, reference Firm has submitted COA of API, and working
standards and impurity standards standard.
7. Documents for the procurement of excipients used Firm has submitted documents for procurement of
in product development? excipients.
8. List of qualified staff involved in product Firm has provided list of technical staff of product
development with relevant experience. development section.
PRODUCTION DATA
9. Authorized Protocols/SOP for the development & Firm has submitted SOPSs for product development.
10. Complete batch manufacturing record of three Firm has provided Batch Manufacturing Record for
stability batches. all the three batches of each strength.
11. Record of remaining quantities of stability batches. Firm has provided following remaining quantities
for each batch:
TF-01: 70 Tablets
TF-02: 98 Tablets
TF-03: 108 Tablets
QA/QC DATA
12. Record of Digital data logger for temperature and Firm has submitted record of Digital data logger for
humidity monitoring of stability chambers (real temperature and humidity monitoring of stability
time and accelerated) chambers.
13. Method used for analysis of API along with COA. Firm has submitted COA and method of analysis of
API.
14. Method used for analysis of FPP & complete record Firm has submitted method of analysis of FPP and
of testing of stability batches (i.e. chromatograms, complete record of testing of stability batches along
lab reports, raw data sheets etc.) with chromatograms
15. Reports of stability studies of API from Firm has submitted both accelerated stability studies
manufacturer. & long term stability studies reports of three batches
of API.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all excipients
used.
17. Drug-excipients compatibility studies. Firm has submitted that they have used same
excipients in their formulation as used by the
innovator. Therefore drug-excipient compatibility
studies are not required.
18. Record of comparative dissolution data. Firm has submitted CDP data of their product
against the Xeljanz Tablet. The drugs show more
than 85% release in 15 minutes at all media.
19. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail reports for HPLC
audit trail reports on product testing. analysis for all the three batches.
Evaluation by PEC:

Submit protocols for stability studies Firm has submitted protocols for stability studies.

You have provided dissolution specifications as NLT Firm has submitted revised dissolution specifications
75% in 15 minutes without specifying the value of with acceptance criteria NLT 75%(Q) after 15
“Q”. minutes
Submit stability study data of API Firm has submitted the stability study data of API for
three batches.
Decision: Registration Board decided to approve registration of Tofacit 5mg Tablet (Tofacitinib, Selective
immunosuppressants, ATC code: L04AA29) with Innovator’s specifications by M/s Kaizen Pharmaceuticals
(Pvt) Ltd., E-127-129, North Western Industrial Zone, Bin Qasim, Karachi. Manufacturer will place first
three production batches on long term stability studies throughout proposed shelf life and on accelerated
Case no. 05: Registration applications of locally manufacturing drugs (human) submitted on CTD
format
1840. Name, address of Applicant / Marketing M/s SAMI Pharmaceuticals (pvt.) Ltd., F-95, Off, Hub
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
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
GMP status of the firm The Firm has submitted copy of GMP certificate granted
based on the inspection dated 28-08-2019.
Evidence of approval of manufacturing The firm has provided Tablet General section as per
facility document of licensing Regularization of DML.
Status of application ☐ New Drug Product (NDP)
☒ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
Dy. No. and date of submission Dy. No.18270 : 23-09-2019
Details of fee submitted PKR 50,000/-: 23-09-2019
The proposed proprietary name / brand EMPOLI Plus 12.5 + 1000mg Tablets
name
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Empagliflozin…………………..12.5mg
Metformin hydrochloride………..1000mg
Pharmaceutical form of applied drug Immediate release film coated Tablets
Pharmacotherapeutic Group of (API) Anti-diabetic
Reference to Finished product specifications Innovator’s Specifications
Proposed Pack size 14’s & 28’s
Proposed unit price As per SRO
The status in reference regulatory authorities Synjardy 12.5mg /1000mg tablet of BOEHRINGER
INGELHEIM (USFDA approved)
For generic drugs (me-too status) Empozin-M 12.5mg + 1000mg tablet of Macter
Name and address of API manufacturer. Empagliflozin: M/s. Fuxin Long Rui Pharmaceutical
Co.,Ltd,
Address: Fluoride Industrial Park, Fumeng County (Yi Ma

Tu), Fuxin City, Liaoning Province -123000, China
Metformin hydrochloride: M/s Wanbury Limited, 10th
Floor, B-wing, BSEL techpark, Sector 30A, Navi Mumbai,
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.
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 product, specifications,
analytical procedures, validation of analytical procedures,
batch analysis, justification of specifications, reference
standard or materials, container closure system and
stability
Module-III Drug Substance: Firm has submitted detailed drug substance data 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.
Stability Studies of Drug Substance Empagliflozin: The submitted stability study data was
(Conditions & duration of Stability studies) conducted at accelerated condition (40 oC ±2oC &
75%±5% RH) for 6 months, 5 years at long term storage
conditions (30 oC ±2oC & 65%±5% RH).
Metformin hydrochloride: The submitted stability study
data was conducted at accelerated condition (40 oC ±2oC &
conditions (30oC±2oC & 75%±5% 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 specifications, reference standard or
materials, container closure system and stability.
Comparative Dissolution Profile Data Firm has submitted results of comparative dissolution
(Details of reference product & study) profile of their Batch No. TFB-T001 with the innovator
product i.e. Xeljanz 5mg Tablet. Firm has performed CDP
in o.1 N HCl, acetate buffer and phosphate buffer. The
results of drug release were greater than 85% in 15 minutes
in all medium therefore the firm did not calculate similarity
factor f2 values.
Analytical method validation/verification of Firm has submitted protocols and reports of validation
product studies of analytical method.

☐ Importer
☐ Export sale
name
Pharmaceutical ingredient (API) per unit Empagliflozin…………………….12.5mg
Proposed unit price ---------
Name and address of API manufacturer. Empagliflozin: Fuxin Long Rui Pharmaceutical Co.,Ltd,
Tu), Fuxin City Liaoning Province -123000, China
India

stability
drug substance.
in 0.1 N HCl, acetate buffer and phosphate buffer. The
factor f2 values.
☐ Importer
☐ Export sale

name
Pharmaceutical ingredient (API) per unit Empagliflozin…………………….12.5mg
India
stability.
drug substance.

factor f2 values.
☐ Importer
☐ Export sale
The proposed proprietary name / brand EMPOLI Plus 5 + 1000mg Tablets
name
Pharmaceutical ingredient (API) per unit Empagliflozin…………………….5mg

The status in reference regulatory authorities Synjardy 5mg /1000mg tablet of BOEHRINGER
For generic drugs (me-too status) Empozin-M 5mg + 1000mg tablet of Macter
India
stability
drug substance.

factor f2 values.
☐ Importer
☐ Export sale
name
India
stability
drug substance.
factor f2 values.
☐ Importer

☐ Export sale
name
Proposed unit price ----------
For generic drugs (me-too status) N/A
India
stability
drug substance.

factor f2 values.
Manufacturer of API Empagliflozin: M/s Fuxin Long Rui Pharmaceutical Co.,Ltd,
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City
Liaoning Province -123000, China
Metformin hydrochloride: M/s Wanbury Limited, 10th Floor, B-wing, BSEL
techpark, Sector 30A, Navi Mumbai, India
API Lot No. Empagliflozin:
Metformin hydrochloride:
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months)
Real Time: 0, 3, 6 (Months)
Strengths applied Batch No Batch size Manufacturing date
EMPOLI Plus 12.5mg + Lab-01 2500 Tablets November 2018
1000mg Tablet Lab-02 1666 Tablets November 2018
Lab-03 1666 Tablets November 2018
EMPOLI Plus 12.5mg + 850mg Lab-01 2500 Tablets December 2018
Tablet Lab-02 2500 Tablets December 2018
Lab-03 2500 Tablets December 2018
EMPOLI Plus 12.5mg + 500mg Lab-01 2500 Tablets December 2018
Tablet Lab-02 2500 Tablets December 2018
Lab-03 2500 Tablets December 2018
EMPOLI Plus 5mg + 1000mg Lab-01 2500 Tablets January 2019

Tablet Lab-02 2500 Tablets January 2019
Lab-03 2500 Tablets January 2019
EMPOLI Plus 5mg + 850mg Lab-01 2500 Tablets January 2019
Tablet Lab-02 2500 Tablets January 2019
Lab-03 2500 Tablets January 2019
EMPOLI Plus 5mg + 500mg Lab-01 2500 Tablets November 2018
Tablet Lab-02 2500 Tablets November 2018
Lab-03 2500 Tablets November 2018
No. of Batches 03
1. Reference of previous approval of applications Firm has referred last onsite panel inspection for instant
with stability study data of the firm (if any) dosage form conducted during last two years TEFOD
(Tenofovir Alafenamide) 25mg Tablets on 28th January,
2019 by following panel:
1. Dr. Rafeeq Alam Khan, Meritorious Professor, Member
Registration Board
2. Mr. Aslam Shah, Member Registration Board.
3. Mr. Affan Ali Qureshi, Assistant Director (CDL),
DRAP, Karachi.
2. Approval of API/ DML/GMP certificate of Empagliflozin: The firm has submitted copy of GMP
API manufacturer issued by concerned certificate for M/s Fuxin Long Rui Pharmaceutical Co.,
regulatory authority of country of origin. Ltd, China issued by Fuxin Food and Drug Administration.
The certificate is valid till 27-09-2020.
Metformin hydrochloride: The firm has submitted copy of
GMP certificate for M/s Wanbury Limited, Andhra
Pradesh, India. The certificate is valid till 05-02-2022.
3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of invoice for the
approval from DRAP (in case of import). import of Empagliflozin (1kg) attested by AD (I&E)
Karachi office dated 08-11-2018.
Metformin hydrochloride: Firm has submitted copy of
invoice for the import of metformin hydrochloride (1.5kg)
attested by AD (I&E) Karachi office dated 25-05-2018.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of all
attested respective documents like batches along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
summary data sheets etc.
5. Compliance Record of HPLC software 21CFR Firm has submitted certificate of compliance along with
& audit trail reports on product testing audit trail record of product testing of HPLC for all test
intervals.
6. Record of Digital data logger for temperature Firm has submitted record of digital data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of real time and
(real time and accelerated). accelerated stability chambers.
Evaluation by PEC
Though you have submitted summary of batch The firm has provided data of relevant section of
analyses release results of the FPP manufacturer for Module 3.
relevant batches in quality overall summary,
however it is not provided in relevant section of
module 3
Analytical Method Verification studies including The firm has submitted analytical method
specificity, accuracy and repeatability (method verification studies for both drug substances.
precision) performed by the Drug Product
manufacturer for both compendial as well as
noncompendial drug substance(s) (Empagliflozin
and metformin hydrochloride) shall be submitted
as per section 3.2.S.4-Control of drug substance
How it is possible even in the presence of stress The firm has submitted that selectivity of method
conditions, no degradation/impurities were can be determined by following two methods
observed in specificity parameter of analytical  Spiking of impurities
validation of finished product. Please justify your  Forced Degradation
findings. We performed both methods and no degradation
has been observed due to high stability of these
molecules.
The justification of specification(s) for non- The firm has submitted that we have developed in-
pharmacopeial products must be provided. house justification for inclusion of tests non-
pharmacopoeial.
Details of reference standards needs to be The firm has submitted that assay of Metformin
submitted since details of metformin impurity A hydrochloride performed by titrimetric method
and metformin impurity F are submitted without hence working standard not required. While for
mentioning API reference standard. In case of testing of finished product, reference standard is
Empagliflozin, working standard of API has been used to standardize the working standard.
procured. Justify the quantity of working standard The firm has submitted justification for quantity of
procured will it be sufficient for complete test and working standard procured for test and analysis.
analysis. Amount of working standard procured is 125mg.
125mg is used for analysis of API.
125mg is used for standardization of in-house
standard.
10mg working standard required for single analysis
of finished product.
No. of testing per strength is 6mg (60mg
consumed).
Total no. of testing per 6 strength is 36mg (360mg
consumed).
Pharmaceutical equivalence of the applied drug The firm has performed pharmaceutical
shall be established with the innovator / reference / equivalence of their test formulations with different
comparator product and results of all the quality strengths of Synjardy as below:
tests (mentioned in any official pharmacopoeia or  Synjardy 12.5/1000mg Tablets (Boehringer
section 3.2.P.5.1 of this application) of the Ingelheim, Batch # 644963)
developed formulation and the innovator /  Synjardy 12.5/850mg Tablets (Boehringer
reference / comparator product should be submitted Ingelheim, Batch # 544531)
and discussed.  Synjardy 12.5/500mg Tablets (Boehringer
Ingelheim, Batch # 856310)
 Synjardy 5/500mg Tablets (Boehringer
Though you have submitted brief summary of CDP The firm has submitted performance of
with innovator in module 2, however the results of comparative dissolution test of their test
comparative dissolution profile conducted in three formulations against innovator formulations in 3
BCS media across the physiological pH range different pH media i.e., 0.1 N HCl, acetate buffer
along with calculation of similarity factor f2 should pH 4.5 and phosphate buffer pH 6.8 for relevant
be submitted and discussed in relevant portion of section of module 3. The results show comparable
module 3. dissolution with innovator’s product
Decision: Registration Board decided to defer the cases for justification of using Titrimetric method
alongwith performance of potentiometric end point for analysis of metformin API.
1846. Name, address of Applicant / Marketing M/s Global Pharmaceuticals (Pvt.) Ltd.

Authorization Holder Plot # 204-205, Industrial Triangle, Kahuta Road,
Islamabad
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd.
Islamabad
☐ Importer
GMP status of the firm The Firm has submitted copy panel inspection dated 24-12-
2018 wherein renewal of DML was granted.
Evidence of approval of manufacturing Firm has submitted copy of Section approval letter dated
facility 13th June, 2107 specifying Tablet General section.
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
Intended use of pharmaceutical product ☐ Domestic sale
☐ Export sale
☒ Domestic and Export sales
Dy. No. and date of submission Dy. No. 28418 : 27-12-2019
Details of fee submitted PKR 20,000/-: 27-12-2019, 30,000/-: 18-08-2020
The proposed proprietary name / brand name D-Pain Tablet 50mg
Pharmaceutical ingredient (API) per unit Tapentadol as hydrochloride…………..50mg
Pharmaceutical form of applied drug Immediate release film coated tablet
Pharmacotherapeutic Group of (API) Other opioids (N02AX06)
Reference to Finished product specifications Innovators specifications
Proposed Pack size 1 x10’s
The status in reference regulatory authorities NUCYNTA 50mg film coated tablets by COLLEGIUM
PHARM (USFDA Approved)
For generic drugs (me-too status) ----
Name and address of API manufacturer. M/s SYMED LABS LIMITED, (UNIT-VI), Survey No.
744, 745, 750, 751, 752, & 753, Mandollagudem (Village),
Choutuppal (Mandal), Yadadri District-508252 Telangana,
India.
manufacturers, Characterization, impurities, specifications,
analytical procedures and its validation, batch analysis and
justification of specification, reference standard, container
closure system and stability studies of drug substance.

stability.
physical form, manufacturers, description of manufacturing
process and controls, impurities, specifications, analytical
procedures and its validation, batch analysis and
Stability Studies of Drug Substance Firm has submitted stability study data of 6 months
(Conditions & duration of Stability studies) accelerated and 12 months real time data of 3 batches of
API.
Pharmaceutical Equivalence and Firm has submitted results of comparative dissolution
Comparative Dissolution Profile profile of their developed product D-Pain 50mg with
comparator product Tapento IR 75mg Tablet. Firm has
performed CDP in 0.1 N HCl, acetate buffer and phosphate
buffer. The results of drug release were greater than 85% in
15 minutes in all medium therefore the firm did not
calculate similarity factor f2 values.
Islamabad
Islamabad
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 28419: 27-12-2019
Details of fee submitted PKR 20,000/-: 27-12-2019, 30,000/-: 18-08-2020
The proposed proprietary name / brand name D-Pain Tablet 75mg

Pharmaceutical ingredient (API) per unit Tapentadol as hydrochloride…………..75mg
Pharmaceutical form of applied drug Immediate release film coated tablet
Pharmacotherapeutic Group of (API) Other opioids (N02AX06)
The status in reference regulatory authorities NUCYNTA 75mg film coated tablets by COLLEGIUM
PHARM (USFDA Approved)
For generic drugs (me-too status) ----
Name and address of API manufacturer. M/s SYMED LABS LIMITED, (UNIT-VI), Survey No.
744, 745, 750, 751, 752, & 753, Mandollagudem (Village),
Choutuppal (Mandal), Yadadri District-508252 Telangana,
India.
manufacturers, Characterization, impurities, specifications,
analytical procedures and its validation, batch analysis and
stability.
Stability Studies of Drug Substance Firm has submitted stability study data of 6 months
(Conditions & duration of Stability studies) accelerated and 12 months real time data of 3 batches of
API.
Pharmaceutical Equivalence and Firm has submitted results of comparative dissolution
Comparative Dissolution Profile profile of their developed product D-Pain 50mg with
comparator product Tapento IR 75mg Tablet. Firm has
performed CDP in 0.1 N HCl, acetate buffer and phosphate
buffer. The results of drug release were greater than 85% in

15 minutes in all medium therefore the firm did not
calculate similarity factor f2 values.
Manufacturer of API M/s SYMED LABS LIMITED, (UNIT-VI), Survey No. 744, 745, 750, 751, 752,
& 753, Mandollagudem (Village), Choutuppal (Mandal), Yadadri District-
508252 Telangana, India.
API Lot No. 6TDL 0110318
Description of Pack
Alu-Alu Blister 1×10’s
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6, 9 (Months)
Batch No. Batch size Manufacturing date
D-PAIN 50MG TABLET T-001
T-002 1500 Tablets 09-2018
T-003
D-PAIN 75MG TABLET T-001
T-002 1000 tablets 09-2018
T-003
1. Reference of previous approval of applications Firm has referred to last onsite panel inspection for instant
with stability study data of the firm (if any) dosage form conducted during last two years Promig plus
Tablets on 13th & 14th March, 2019 which confirms that :
HPLC is 21 CFR II compliant.
Digital data loggers were available for continuous
monitoring of temperature and humidity.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate
API manufacturer issued by concerned (Certificate#JX170001) for M/s Symed Labs Limited,
regulatory authority of country of origin. India issued by Drug Control Administration, Government
of Telangana, India. It was valid till 24-04-2018.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice specifying
approval from DRAP (in case of import). import of 2.0Kg of Tapentadol Hydrochloride. The invoice
is attested by AD (I&E) DRAP Islamabad office dated 29-
03-2018.
intervals.

Dissolution conditions of innovator as per Biopharmaceutics Review:
Apparatus: Type I (Basket apparatus)
Spindle rotation: 75 RPM
Medium: 0.1 M HCl
Medium volume: 900ml
Time: 45 min
Acceptance criteria: NLT 80% (Q) of the labelled amount of Tapentadol (as HCl) dissolved in 45 min
Sr. Observations communicated Response by the firm

No.
1. Submit Quality Overall Summary (QOS) The firm has submitted summarised information
needs to be submitted as per 293rd meeting of of drug substance and drug product as per 293rd
Registration Board. meeting of Registration Board
2. Evidence of import of API including copy of Firm has submitted copy of commercial invoice
commercial invoice cleared by DRAP field specifying import of 2.0Kg of Tapentadol
office. Hydrochloride. The invoice is attested by AD
(I&E) DRAP Islamabad office dated 29-03-
2018.
3. GMP certificate of API manufacturer issued The firm has submitted copy of GMP certificate
by regulatory authority of country of origin however it is expired now.
needs to be submitted.
4. Provide certificate of analysis of each batch Submitted
of API used in the stability studies of the
three submitted batches.
5. Summary of batch analyses release results of Submitted
the drug product manufacturer for relevant
batch needs to be submitted as per 2.3.S.4.4
(b).
6. Provide data of pharmaceutical equivalence The firm has submitted that we performed
against innovator product including data of pharmaceutical equivalence against comparator
comparative dissolution profile to justify product that is Tapento IR 75mg tablet.
your formulation development as per the Unfortunately we are unable to arrange innovator
requirement of section 3.2.P.2.2.1. pack / comparator of one of its strength i.e., 50mg
Tablet. Being same dosage form and same kind
of release profile of both strengths, the firm has
requested to accept the study of higher strength
of same product against it lower strength also.
7. Submit data to comply the decision of 293rd Submitted.
meeting of Registration Board, which states
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”.
8. The drug substance and drug product part of The firm has submitted data of relevant modules.
Module III needs to be submitted as per 293rd
meeting of registration covering all the
sections mentioned in that document.
 To defer registration application of D-Pain 50mg Tablet for submission of pharmaceutical
equivalence and comparative dissolution profile with innovator / comparator product of same
strength.
 To approve registration of D-Pain 75mg tablet by M/s Global Pharmaceuticals (Pvt.) Ltd. Plot #
204-205, Industrial Triangle, Kahuta Road, Islamabad. Manufacturer will place first three
studies for six months. Manufacturer will also perform process validation studies on first three
commercial batches as per the commitment submitted along with registration application.
Islamabad
Islamabad
☐ Importer
☐ Export sale
Details of fee submitted PKR 20,000/-: 21-02-2020, 30,000/- 10-03-2020
The proposed proprietary name / brand name Asprala 81mg/40mg Tablet
Strength / concentration of drug of Active Each Film coated delayed release tablet contains:
Pharmaceutical ingredient (API) per unit Aspirin…………..81mg (Delayed release)
Omeprazole……….40mg (Immediate release)
Pharmaceutical form of applied drug Film coated delayed release Tablet
Pharmacotherapeutic Group of (API) Antiplatelet agent and proton pump inhibitor
The status in reference regulatory authorities YOSPRALA Tablets 81mg /40mg by Arelez
Pharmaceuticals (USFDA approved)
For generic drugs (me-too status) OMO/ASPER Tablets 81mg /40mg by M/s Helix
Name and address of API manufacturer. Aspirin: M/s Shangdong Xinhua Pharmaceutical Co. Ltd.
14 Dongyi Road, Zhangdian District, Zibo city, Shangdong
province, China
Omeprazole: M/s Everest Organics Limited, Sadasivpet
(Mandal) Medak, Andra Pradesh, India

Stability Studies of Drug Substance Aspirin: The Firm has submitted 6months accelerated
(Conditions & duration of Stability studies) (40oC ± 2oC/75%± 5% RH) and 60months real time (30oC
± 2 oC/60%± 5% RH) stability study data of 3 batches.
Omeprazole: The Firm has submitted 6months accelerated
(40oC ± 2oC/75%± 5% RH) and 48months real time (30oC
Pharmaceutical Equivalence and Firm has submitted comparative dissolution study of their
Comparative Dissolution Profile Batch No. TT-001 with the innovator product i.e. Yosprala
325/40mg Tablets. Firm has performed CDP in 0.1 N HCl,
acetate buffer and phosphate buffer. Comparison of results
indicate that omeprazole releases more than 85% in 10
minutes in pH 1.2 and 6.8, therefore calculation for f2 factor
was not made. However, for aspirin F2 factor is 58.42,
hence dissolution profile of both products found
comparable.
Islamabad
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt.) Ltd.,
Islamabad
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 4210 : 11-03-2020
Details of fee submitted PKR 20,000/-: 21-02-2020, 30,000/- 10-03-2020
The proposed proprietary name / brand name Asprala 325mg/40mg Tablet
Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Aspirin…………..325mg (Delayed release)
Omeprazole……….40mg (Immediate release)
Pharmaceutical form of applied drug Uncoated Tablet
Pharmacotherapeutic Group of (API) Antiplatelet agent (B01AC06)
The status in reference regulatory authorities YOSPRALA Tablets 325mg /40mg by Arelez
Pharmaceuticals (USFDA approved)
For generic drugs (me-too status) OMO/ASPER Tablets 325mg /40mg by M/s Helix
Name and address of API manufacturer. Aspirin: M/s Shangdong Xinhua Pharmaceutical Co. Ltd.
14 Dongyi Road, Zhangdian District, Zibo city, Shangdong
province, China
Omeprazole: M/s Everest Organics Limited, Sadasivpet
(Mandal) Medak, Telangana, India
Stability Studies of Drug Substance Aspirin: The Firm has submitted 6months accelerated
(Conditions & duration of Stability studies) (40oC ± 2 oC/75%± 5% RH) and 60months real time (30oC
Omeprazole: The Firm has submitted 6months accelerated
(40oC ± 2 oC/75%± 5% RH) and 48months real time (30oC
Pharmaceutical Equivalence and Firm has submitted comparative dissolution study of their
Comparative Dissolution Profile Batch No. TT-001 with the innovator product i.e. Yosprala
325/40mg Tablets. Firm has performed CDP in 0.1 N HCl,
acetate buffer and phosphate buffer. Comparison of results
indicate that omeprazole releases more than 85% in 10
minutes in pH 1.2 and 6.8, therefore calculation for f2 factor

was not made. However, for aspirin F2 factor is 58.42,
hence dissolution profile of both products found
comparable.
Manufacturer of API Aspirin: M/s Shangdong Xinhua Pharmaceutical Co. Ltd. 14 Dongyi Road,
Zhangdian District, Zibo city, Shangdong province, China
Omeprazole: M/s Everest Organics Limited, Sadasivpet (Mandal) Medak,
Telangana, India
API Lot No. Aspirin: 171315
Omeprazole: OME/E-222/16
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0, 1, 2, 3,4, 6 (Months)
Batch No. Batch size Manufacturing date
ASPRALA 81MG/40MG TT-001 13000 Tablets 06-2018
TABLET TT-002 13000 Tablets 06-2018
TT-003 13000 Tablets 06-2018
ASPRALA 325MG/40MG TT-001 1500 Tablets 09-2019
TABLET TT-002 1500 Tablets 09-2019
TT-003 1500 Tablets 09-2019
1. Reference of previous approval of applications Firm has referred to last onsite panel inspection for instant
with stability study data of the firm (if any) dosage form conducted during last two years Promig plus
Tablets on 13th & 14th March, 2019 which confirms that :
HPLC is 21 CFR II compliant.
Digital data loggers were available for continuous
monitoring of temperature and humidity.
2. Approval of API/ DML/GMP certificate of Aspirin: The firm has submitted copy of GMP certificate
API manufacturer issued by concerned for M/s Shangdong Xinhua Pharmaceutical Co. Ltd. 14
regulatory authority of country of origin. Dongyi Road, Zhangdian District, Zibo city, Shangdong
province, China issued by Shangdong Food and Drug
Administration. It is valid till 18-10-2022.
Omeprazole: The firm has submitted copy of GMP
certificate for M/s Everest Organics Limited, Sadasivpet
(Mandal) Medak, Telangana, India issued by Government
of Telangana, Drugs Control administration. It was valid
till 31-03-2017.
3. Documents for the procurement of API with Aspirin: Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). specifying import of 5Kg of Aspirin. The invoice is
attested by AD (I&E) DRAP Islamabad office dated 11-
06-2018.
Omeprazole: Firm has submitted copy of commercial
invoice specifying import of 100Kg of Aspirin. The
invoice is attested by AD (I&E) DRAP Islamabad office
dated 13-05-2016.
intervals.
Sr. Observations communicated Response by the firm

No.
1. Evidence of import of API including copy Evidence of import of both APIs attested by AD
of commercial invoice cleared by DRAP (I&E), Islamabad is submitted
field office.
2. GMP certificate of API manufacturer Valid GMP certificate for omeprazole is yet to
issued by regulatory authority of country of be submitted.
origin needs to be submitted.
3. Provide certificate of analysis of each batch Submitted
of API used in the stability studies of the
three submitted batches.
4. Provide data of pharmaceutical equivalence The firm has submitted that we performed
against innovator product including data of pharmaceutical equivalence against comparator
comparative dissolution profile to justify product that is Yosprala 325mg/40mg tablet.
your formulation development as per the But unfortunately we are unable to arrange
requirement of section 3.2.P.2.2.1. innovator pack / comparator of one of its
strength i.e., Yosprala 81mg/40mg Tablet.
Being same dosage form and same kind of
release profile of both strengths, the firm has
requested to accept the study of higher strength
of same product against it lower strength also.
5. Submit data to comply the decision of 293rd The firm has submitted analytical method
meeting of Registration Board, which states validation studies.
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”.
6. The drug substance and drug product part The firm has submitted details of drug substance
of Module III needs to be submitted as per and drug product as per 293rd meeting of
293rd meeting of registration covering all Registration Board.
the sections mentioned in that document.
 to defer registration application of Asprala 81mg/40mg Tablet for submission of pharmaceutical
equivalence and comparative dissolution profile with innovator / comparator product of same
strength.
 to approve registration of Asprala 325mg/40mg Tablet by M/s Global Pharmaceuticals (Pvt.) Ltd.
Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad. Manufacturer will place first three

studies for six months. Manufacturer will also perform process validation studies on first three
commercial batches as per the commitment submitted along with registration application.
Item No. : Agenda of Evaluator AD PEC-I
Item No. I: Registration Applications for Local Manufacturing of (Human) Drugs

a. New Cases
1850. Name and address of manufacturer / M/s Skim Pharmaceuticals 10/B value addition city
Applicant Faisalabad
Brand Name +Dosage Form + Strength SKIFENAC Diclofenac Sodium 50mg sustain coated
pellets
Diary No. Date of R& I & fee Each capsule contains:
Diclofenac sodium sustained release pellets….50mg
Source of Pellets:
M/s Vision Pharmaceutical Islamabad
Composition Dy. No. 20075 dated 04-06-2018 Rs20,000/-Dated 04-06-
18
Type of Form Form-5
Pack Size & Demanded Price 20,s capsule in Alu/PVC Blister & As per SRO
Approval Status of Product in Reference Diclofenac sodium 25mg & 50mg) gastro resistant Tablet
Regulatory Authorities by M/s Daxcel Pharma, MHRA Approved.
Me-too Status Lifdik 50mg capsule by M/s Goodmann, Reg No. 52586
GMP Status DML No. 000830 issue dated 03-12-2015 Panel
recommended additional sections including Capsule
(general) dated 19-01-2018
Remarks of the Evaluator-I The firm initially applied for Sustained Release Capsule and
then it was revised as Enteric coated Capsule as per
reference product and submitted fee Rs. 5,000/- vide challan
number 0300788 dated 13/04/2020.
1851. Name and address of manufacturer / M/s AGP Limited, B-23, S.I.T.E. Karachi
Applicant
Brand Name +Dosage Form + Strength Paliga XR 1.5mg Tablet
Composition Each Film Coated Extended Release Tablet Contains:
Paliperidone…….1.5mg
Type of Form Form 5
Finished Product Specification MFG Spcs
Pack Size & Demanded Price 14’s, Rs. 1000/-
Approval Status of Product in Reference NVEGA® (paliperidone) Extended-Release Tablets
Regulatory Authorities (1.5mg, 3mg, 6mg, 9mg) by M/s Janssen Pharmaceuticals,
Inc., USFDA Approved.
Me-too Status Paliris-XR Tablets 1.5mg by M/s Genome
Pharmaceuticals (Pvt) Ltd. Reg. No. 079270
GMP Status GMP granted on the basis of inspection dated 16.10.2018
Remarks of the Evaluator-I The reference product Invega, approved by USFDA is
prolonged release tablet manufactured by OROS Push-Pull
Technology and the public assessment report describes that
osmotic pressure delivers paliperidone from the dosage form
at a controlled rate.
While the firm has stated that the product will be
manufactured with simple matrix system.

Decision: Deferred for clarification regarding method of manufacturing as the reference product is
manufactured by OROS Push-Pull Technology while the submitted method of manufacturing for
applied product is different.
Applicant
Brand Name +Dosage Form + Strength Paliga XR 9mg Tablet
Paliperidone…9mg
Pack Size & Demanded Price 14’s price Rs. 4000/-
Me-too Status Could not be confirmed
Remarks of the Evaluator-I  The reference product Invega, approved by USFDA is
Technology and the public assessment report describes
that osmotic pressure delivers paliperidone from the
dosage form at a controlled rate. While the firm has stated
that the product will be manufactured with simple matrix
system.
 Me too status could not be confirmed.
Decision: Deferred for;
 Clarification regarding method of manufacturing as the reference product is manufactured by
OROS Push-Pull Technology while the submitted method of manufacturing for applied
product is different.
Applicant
Diary No. Date of R& I & fee Dy.No 38173 dated 20-11-2018 Rs.20,000/- Dated
Paliperidone…6mg
Type of Form Form 5
Me-too Status Avega 6mg Tablets by M/s Biogen Pharma, Reg No.
080370

Applicant
Paliperidone………3mg
Type of Form Form 5
Approval Status of Product in Reference NVEGA® (paliperidone) Extended-Release Tablets 1.5mg,
Regulatory Authorities 3mg, 6mg, 9mg) by M/s Janssen Pharmaceuticals, Inc.,
USFDA Approved.
Me-too Status Paliris-XR Tablets 3mg by M/s Genome Pharmaceuticals
(Pvt) Ltd. Reg. no. 079271
1855. Name and address of manufacturer / M/s Getz Pharma Pvt Ltd, 29-30/27, Korangi Industrial
Brand Name +Dosage Form + Strength Safiget 50mg Tablets
Diary No. Date of R& I & fee Form-5D Dy.No 37929 dated 16-11-2018 Rs.50,000/-
Dated 15-11-2018
Safinamide as Mesylate………50mg
Pharmacological Group antiparkinsonism
Finished Product Specification Mfg Spec
Pack Size & Demanded Price 30’s, price Rs. 12,000/-
Approval Status of Product in Reference Xadago (50mg & 100mg) film coated tablet by M/s US
Regulatory Authorities WORLDMEDS LLC, USFDA Approved
Me-too Status N/A
GMP Status Last inspection report dated 26/06/2018 acceptable
Remarks of the Evaluator-I The firm has claimed In-House specifications and the
product is not present in available pharmacopoeia (USP, BP,
IP, JP).
06 month submit stability data (Real time and Accelerated
stability studies) as per guidelines/decision of 278th meeting
Registration Board of 03 batches.
Decision: Deferred for submission of stability data of 03 batches as per the guidelines/decision of
293rd meeting of Registration Board.
1856. Name and address of manufacturer / M/s Getz Pharma Pvt Ltd, 29-30/27, Korangi Industrial
Brand Name +Dosage Form + Strength Safiget 100mg Tablets

Diary No. Date of R& I & fee Form-5D Dy.No 37928 dated 16-11-2018 Rs.50,000/-
Dated 15-11-2018
Safinamide as Mesylate….…100mg
Pharmacological Group antiparkinsonism
Finished Product Specification Mfg Spec
Pack Size & Demanded Price 30’s, price Rs. 20,000/-
Approval Status of Product in Reference Xadago (50mg & 100mg) film coated tablet by M/s US
Regulatory Authorities WORLDMEDS LLC, USFDA Approved
Me-too Status N/A
GMP Status Last inspection report dated 26/06/2018 acceptable
Remarks of the Evaluator-I Stability data (Real time and Accelerated stability studies)
as per guidelines/decision of 278th meeting Registration
Board of 03 batches.
Decision: Deferred for submission of stability data of 03 batches as per the guidelines/decision of
293rd meeting of Registration Board.
1857. Name and address of manufacturer / M/s Navegal Laboratories, 41/1-A2, Phase-1, Industrial
Applicant Estate, Hattar
Brand Name +Dosage Form + Strength Diclotol 50mg/200mcg Tablets
Type of Form Form 5
Pack Size & Demanded Price 2×10’s, price as per SRO
Approval Status of Product in Reference Arthrotec 50 modified-release tablets by M/s Pfizer, MHRA
Me-too Status Prostol Tablets by M/s Flow Pharmaceutical (Pvt) Ltd, 17-
KM Sheikhupura Road, Lahore, Reg. No. 026839
GMP Status The GMP of the firm was satisfactory on the basis of inspected
conducted on 11/03/2019.
(Sections: Tablet general, Tablet Psychotropic, Capsule ,
General, Capsule Cephalosporin, Dry Powder Cepalosporin)
Remarks of the Evaluator-I The composition of applied product is different from the
reference product and is given in the following;
Each delayed release tablet contains:
While the composition of the reference product is;
Clarify or otherwise submit revised formulation along with
the submission of requisite fee.
Decision: Deferred for submission of evidence of approval of applied formulation as “delayed
release 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.
Brand Name +Dosage Form + Strength Diclotol 75mg/200mcg Tablets

Type of Form Form 5
Pack Size & Demanded Price 2×10’s, Price as per SRO
Approval Status of Product in Reference Arthrotec 75 modified-release tablets by M/s Pfizer, MHRA approved
Me-too Status Arsofin Tablets by M/s Martin Dow Pharmaceuticals
(Pakistan) Ltd, Reg. no. 48013
Remarks of the Evaluator-I The composition of applied product is different from the
reference product and is given in the following;
Each delayed release tablet contains:
While the composition of the reference product is;
Clarify or otherwise submit revised formulation along with
the submission of requisite fee.
Decision: Deferred for submission of evidence of approval of applied formulation as “delayed
release tablets” in reference regulatory authorities/agencies which were adopted by the Registration
Brand Name +Dosage Form + Strength Zipdone 40mg Capsule
Ziprasidone as HCl monohydrate……….40mg
Type of Form Form 5
Pack Size & Demanded Price 1×14’s, Price as per SRO
Approval Status of Product in Reference Geodon capsule (20mg, 40mg, 60mg, 80mg) by M/s Pfizer,
Me-too Status Ziprox 40mg capsule of M/s Nabiqasim Industries
(Reg.#055651)
Remarks of the Evaluator-I The reference product contains Ziprasidone hydrochloride
monohydtrate while the applied formulaiton contains
Ziprasidone hydrochloride, clarify or otherwise submit
revised formulation along with the submission of requisite
fee.
Decision: Deferred for submission of evidence of approval of applied formulation containing
“Ziprasidone Hydrochloride” 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.
1860. Name and address of manufacturer / Manufactured By: M/s Palpex Pharmaceuticals (Pvt) Ltd.,
Applicant St-1, Sector 38, Korangi Creek Industrial Park, Karachi
Applicant/Manufactured for: M/s Nicholas
Contract manufacturing Pharmaceuticals, Plot # 34, St. # SS-02, National Industrial
Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength N-Mol 1g/100ml Infusion
(solution for injection)
Diary No. Date of R& I & fee Dy. No. 37901 dated 16-11-2018 Rs.50,000/-
Paracetamol……….1g
Pharmacological Group Antipyretic
Type of Form Form 5
Finished Product Specification Mfg specs
Approval Status of Product in Reference Paracetamol 10mg/ml Solution for Infusion (50ml vial, 100ml vial)
Regulatory Authorities by M/s Accord UK ltd, MHRA approved
Me-too Status Provas Infusion 10mg/ml by M/s Sami Pharma, Reg. No.
53223
GMP Status Palpex Pharma: GMP Certificate issued on 08/02/2019 on
the basis of inspection conducted on 31/01/2019.
Sterile Injectable Liquid vial section General Available.
Sections:
Tablet General
Capsule General & Cephalosporin
Dry Powder Suspension General and Cephalosporin
Dry Powder Vial Injection Cephalosporin
Sterile Injectable Liquid Ampoule
Sterile injectable Liquid Vials
Sterile Dry Powder Vials
Nicholas Pharma: DML was issued w.e.f 29/08/2018 vide
letter no. F.1-14/2014-Lic dated 29/08/2018.
Remarks of the Evaluator-I The applicant has 4 sections and no product is being
manufactured on contract currently.
Decision: Deferred for capacity assessment of M/s Nicholas Pharma.
Manufactured for: M/s Nicholas Pharmaceuticals, Plot #
Contract manufacturing 34, St. # SS-02, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Ferolas 100mg/5ml Injection
Composition Each 5ml (ampoule) Contains:
Iron as Iron Sucrose………100mg
Pharmacological Group Antianemic
Type of Form Form 5
Approval Status of Product in Reference Venofer Injection M/s Vifor (MHRA Approved).
Me-too Status Iroject Injection by M/s Medley Pharmaceuticals
(Reg#070173)
Sections:
Tablet General

Brand Name +Dosage Form + Strength N-Ton 8mg/4ml Injection
14-11-2018
Composition Each 4ml ampoule Contains:
Ondansetron………8mg
Pharmacological Group Anti-emetic
Type of Form Form 5
Approval Status of Product in Reference Ondansetron 2 mg/ml (4mg/2ml & 8mg/4ml) Solution for Injection
Regulatory Authorities by M/s Hameln pharmaceuticals, MHRA Approved
Me-too Status Doston 8mg/4ml Injection by M/s Vision Pharmaceuticals,
Kahuta Road, Islamabad. Reg. No. 081892
Sections:
Tablet General
Brand Name +Dosage Form + Strength N-Lac 30mg/ml Injection
2018
Composition Each Ampoule (1ml) Contains:
Ketorolac Tromethamine………..30mg
Type of Form Form 5

Approval Status of Product in Reference Toradol Injection 30mg/ampoule of 1ml by M/s Atnahs
Regulatory Authorities Pharma, UK (MHRA Approved)
Me-too Status Tromit Injection by M/s harm (Reg.# 049958)
Sections:
Tablet General
Brand Name +Dosage Form + Strength N-Bufin 10mg/ml Injection
Composition Each Ampoule (1ml) Contains:
Nalbuphine HCl…………10mg
Type of Form Form 5
Finished Product Specification Mfg Specs
Approval Status of Product in Reference NUBAIN (Nalbuphine Hydrochloride) Injection, 10 mg/mL
Regulatory Authorities (1ml ampule). Health Canada approved.
Me-too Status Nalburax Injection by M/s Mediceena Pharma (Pvt) Ltd,
Reg. No. 28830
Sections:
Tablet General
Brand Name +Dosage Form + Strength Penzol 40mg/Vial Injection
(Lyophilized powder for solution for injection)

2018
Pantoprazole as Sodium ………..40mg
Type of Form Form 5
Approval Status of Product in Reference PROTONIX IV 40mg Powder (freeze dried) for Solution for Injection
Regulatory Authorities by M/s Wyeth Pharms, USFDA Approved.
Me-too Status Zonpep Injection 40mg IV by M/s Aulton Pharmaceuticals,
Reg. No.
Sections:
Tablet General
Brand Name +Dosage Form + Strength N-D3 5mg/ml Injection
Composition Each Ampoule (ml) Contains:
Cholecalciferol……..5mg (Eq. to approx. 200,000IU)
Pharmacological Group Vitamin D analogue
Type of Form Form 5
Approval Status of Product in Reference Vitamin D3 Good 200,000 IU / 1 ml IM solution for
Regulatory Authorities injection of (ANSM France approved)
Me-too Status G-Cal 5mg Injection by M/s Glitz Pharmaceuticals, Reg.
No. 66362
Sections:
Tablet General

Brand Name +Dosage Form + Strength N-Zole 40mg/Vial IV Infusion
(Lyophilized Powder for solution)
14-11-2018
Omeprazole as Sodium…..…40mg
Type of Form Form 5
Approval Status of Product in Reference Omeprazole 40mg Powder for Solution for Infusion by M/s Sandoz
Regulatory Authorities Limited, MHRA Approved.
Me-too Status RISEK 40MG INJECTION. Reg. No. 45617
Sections:
Tablet General
Brand Name +Dosage Form + Strength Lasomycin 1g Injection
(Powder for solution)
14-11-2018
Vancomycin as HCl…….1000mg
Type of Form Form 5
Approval Status of Product in Reference Vancomycin Hydrochloride 500mg and 1g Powder for Concentrate
Regulatory Authorities for Infusion by M/s Hospira Uk , MHRA Approved.
Me-too Status Vancocin Inection 1000mg of Eli Lilly Pakistan, Reg. No.
21081

Sections:
Tablet General
Brand Name +Dosage Form + Strength Lasomycin 500mg Injection
Vancomycin as Hcl….500mg
(powder for injection)
Type of Form Form 5
Approval Status of Product in Reference Vancomycin Hydrochloride 500mg and 1g Powder for Concentrate
Regulatory Authorities for Infusion by M/s Hospira Uk , MHRA Approved.
Me-too Status VANCIN I.M / I.V INJECTION 500MG by M/s
CENTURY PHARMACEUTICAL (PVT) LTD, Reg. No.
22673
Sections:
Tablet General
Brand Name +Dosage Form + Strength N-Cycline 50mg Injection
(Powder for solution)
Tigecycline………..50mg
Pharmacological Group Tetracycline derived antibiotic

Type of Form Form 5
Approval Status of Product in Reference Tigecycline 50 mg lyophilized cake or powder for solution for
Regulatory Authorities infusion by M/s Mylan (MHRA Approved)
Me-too Status Tygacil Injection 50mg by M/s Wyeth (Reg#045642)
Sections:
Tablet General
Brand Name +Dosage Form + Strength N-Ronic 3mg/3ml Injection
Ibandronic Acid……….3mg
Pharmacological Group Bone resorption inhibitor
Type of Form Form 5
Approval Status of Product in Reference Ibandronate sodium 3mg/3ml vial by M/s Sun Pharm,
Me-too Status Ibro injection 3mg/3ml by M/s Regal Pharmaceuticals
(Reg#082004)
Sections:
Tablet General

Contract manufacturing Manufactured for: M/s Nicholas Pharmaceuticals, Plot #
34, St. # SS-02, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength N-Esom IV 40mg Injection
(Lyophilized Powder for Solution)
Esomeprazole as Sodium………40mg
Type of Form Form 5
Approval Status of Product in Reference Nexium IV 40mg/vial injection by M/s ASTRAZENECA
Regulatory Authorities PHARMS (USFDA approved)
Me-too Status Esold 40mg/vial Injection of M/s Weather Folds
Sections:
Tablet General
1873. Name and address of manufacturer / M/s Universal Pharmaceuticals Pvt Ltd.
Applicant 131-A, Hayatabad Industrial Estate, Peshawar.
Brand Name +Dosage Form + Strength Loxicam 4mg Tablet
Lornoxicam……….4mg
Pharmacological Group Anti-inflammatory
Type of Form Form 5
Pack Size & Demanded Price 10’s, price as per SRO
Approval Status of Product in Reference Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG, (Swiss
Regulatory Authorities Medic approved)
Me-too Status Acabel 4mg Tablet by M/s Continental Pharma (Reg
No:061603)
GMP Status GMP status could not be confirmed
Remarks of the Evaluator-I
Decision: Registration Board referred the case to QA & LT Division to conduct GMP inspection of
Firm on priority.
Brand Name +Dosage Form + Strength Loxicam 8mg Tablet
Lornoxicam………..8mg
Pharmacological Group Anti-inflammatory
Type of Form Form 5
Approval Status of Product in Reference Xefo 8 mg tablet (EMA approved)
Me-too Status Recam Tablet 8 mg by M/s Regal Pharmaceuticals
(Reg.#081952)
Firm on priority.
Brand Name +Dosage Form + Strength Parox-Q CR 25mg Tablet
Composition Each Enteric, film coated Controlled Release Tablet
Contains:
Paroxetine as HCl……..25mg
Pharmacological Group Anti-depressants
Type of Form Form 5
Approval Status of Product in Reference Paxil CR 25mg Tablet by M/s Apotex Technologies USFDA
Me-too Status Paroxin CR Tablets 25mg by M/s Shrooq pharmaceuticals
(Reg#060470).
Remarks of the Evaluator-I The firm has revised the formulation from Film coated tablet
to Eneric Film Coated Controlled Released Tablet and
submitted Rs. 5000/- vide challan number 2008473 dated
24/01/2020.
 Submission of remaining fee of Rs. 15,000/- for revision of formulation as per the reference
product.
 Moreover, Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority.
Brand Name +Dosage Form + Strength Parox-Q CR 12.5mg Tablet
Contains:
Paroxetine as HCl………12.5mg
Type of Form Form 5
Finished Product Specification Anti-depressants
Approval Status of Product in Reference Paxil CR 12.5mg Tablet of M/s Apotex Technologies
Regulatory Authorities (USFDAApproved)
Me-too Status Panox CR Tablet 12.5mg of M/s Regal Pharma
(Reg.#081953)
Remarks of the Evaluator-I The firm has revised the formulation from Film coated tablet
to Eneric Film Coated Controlled Released Tablet and
submitted Rs. 5000/- vide challan number 2008474 dated
24/01/2020.

 Submission of remaining fee of Rs. 15,000/- for revision of formulation as per the reference
product.
 Moreover, Registration Board referred the case to QA & LT Division to conduct GMP
Brand Name +Dosage Form + Strength Uniterf Fort 250mg Tablet
Terbinafine as HCL………250mg
Type of Form Form 5
Finished Product Specification USP Specifications
Approval Status of Product in Reference Lamisil® Tablets 250mg by M/s NOVARTIS PHARMACEUTICALS
Regulatory Authorities UK LIMITED, MHRA Approved.
Me-too Status Logirid Tablet 250mg by M/s Lowitt Pharmaceutical (Pvt)
Ltd, Reg No. 80847
Firm on priority.
Brand Name +Dosage Form + Strength Dianil 2mg Capsule
Loperamide Hydrochloride…2mg
Pharmacological Group Antidiarrheals
Type of Form Form 5
Pack Size & Demanded Price 6×10, price as per SRO
Approval Status of Product in Reference Loperamide Capsules 2 mg by M/s Galpharm Healthcare Limited,
Me-too Status LOPAMIDE 2mg CA by M/s Medicaids, Reg. No. 11240
Firm on priority.
1879. Name and address of manufacturer / M/s Ciba Pharmaceutical private limitd, plot no. A-371,
Applicant Nooriabad site industrial Area, Super highway Karachi.
Brand Name +Dosage Form + Strength LINO 500mg capsule
Diary No. Date of R& I & fee Dy.No.35276 dated 24/10/2018 PKR 20,000/-
Lincomycin……..500mg
Type of Form Form 5
Pack Size & Demanded Price 5’s×2,6’s×2, 5’s×10, 10’s×20, price as per SRO
Approval Status of Product in Reference Could not be confirmed.
Me-too Status Linnco 500mg Capsule (Lincomycin as HCl) by Mafins
Pharmaceuticals (Pvt) Ltd., Karachi. Reg. No. 79898
GMP Status According to the Last inspection report dated 07/02/2017, the
firm is strictly following the GMP practice.

Remarks of the Evaluator-I The applied product is present in USP as well as BP. The USP
has specified Raman spectroscopy for dissolution study of
Lincomycin capsules. Provide the proof of availability of
Raman spectrometer if you want to claim USP specifications
for the applied product.
Provide evidence of approval of the applied product is
Reference Regulatory Authorities approved by 275th
meeting of Registration Board as the product is
discontinued by USFDA and ANSM France.
1880. Name and address of manufacturer / Applicant: M/s Jinnah Pharmaceuticals Pvt Ltd. 13 km,
Applicant Lahore Road, Multan
Manufactured By: M/s Aventek Pharmaceuticals. 44-C,
Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Jizdime 1gm IV Dry Powder Injection
06-03-2019
Ceftazidime as Pentahydrate…1gm
Type of Form Form-5
Approval Status of Product in Reference Ceftazidime as pentahydrate (500mg&1000mg) Powder for
Regulatory Authorities Solution for Injection by M/s Villerton Invest SA, MHRA
Approved
Me-too Status Fortez Injection 1000mg IM/IV by M/s Biocef
(Pvt)Ltd.,Reg. no. 82749
GMP Status Jinnah Pharma:
The panel recommended renewal of DML, inspection date
03/05/2019.
Aventek Pharma:
GMP inspection report dated 01-01-2019, firm maintained
satisfactory conformance to GMP compliance in the
manufacturing and quality control operations
Decision: Deferred for consideration of the applications on its turn/queue.
Brand Name +Dosage Form + Strength Jizdime 500mg IV Dry Powder Injection
06-03-2019
Type of Form Form-5
Approval Status of Product in Reference Ceftazidime as pentahydrate (500mg&1000mg) Powder for
Regulatory Authorities Solution for Injection by M/s Villerton Invest SA, MHRA
Approved
Me-too Status Fortez Injection 500mg IM/IV by M/s Biocef (Pvt)Ltd.,Reg.
no. 82750
03/05/2019.
Aventek Pharma:
Brand Name +Dosage Form + Strength J-Pime 1gm IV Injection
2019
Cefepime as HCl…1gm
Type of Form Form-5
Approval Status of Product in Reference Cefipime hydrochloride 1gm with L-Arginine Injection
Regulatory Authorities M/s Hospira, Inc. (USFDA approved)
Me-too Status Nuxipim 1gm Injection by M/s Bosch, Reg. No. 44357
03/05/2019.
Aventek Pharma:
Remarks of the Evaluator-I The product approved in reference country contains L-
Arginine in addition to the API while the applied product
contains only API. Clarify or otherwise submit revised
formulation containing L-Arginine.
Brand Name +Dosage Form + Strength J-Pime 500mg IV Injection
2019
Cefepime as HCl…1gm
Type of Form Form-5
Approval Status of Product in Reference Cefipime hydrochloride with L-Arginine 500mg Injection
Regulatory Authorities M/s Hospira, Inc. (USFDA approved)
Me-too Status Nuxipim 500mg Injection by M/s Bosch, Reg. No. 44356
03/05/2019.
Aventek Pharma:

Remarks of the Evaluator-I The product approved in reference country contains L-
Arginine in addition to the API while the applied product
contains only API. Clarify or otherwise submit revised
formulation containing L-Arginine.
Brand Name +Dosage Form + Strength J-Cef 250mg IV Dry Powder Injection
2019
Type of Form Form-5
Approval Status of Product in Reference Ceftriaxone (250mg & 1gm) powder for solution for
Regulatory Authorities injection by M/s Villerton Invest SA, MHRA Approved.
Me-too Status Unixone Injection 250mg IM by M/s Caliph
pharmaceuticals (Pvt.) Ltd, Reg. no. 82556
03/05/2019.
Aventek Pharma:
Brand Name +Dosage Form + Strength Jizdime 250mg IM Dry Powder Injection
06-03-2019
Type of Form Form 5
Approval Status of Product in Reference CEFTAZIDIME PANPHARMA CHILDREN AND
Regulatory Authorities INFANTS 250 mg powder for solution for injection by M/s
PANPHARMA MHRA Approved.
Me-too Status Fortez Injection 250mg IM/IV by M/s Biocef (Pvt)Ltd.,Reg.
no. 82751
03/05/2019.
Aventek Pharma:

Brand Name +Dosage Form + Strength J-Cef 500mg IM Dry Powder Injection
2019
Type of Form Form-5
Approval Status of Product in Reference Ceftriaxone powder for injection (250mg, 500mg, 1000mg,
Regulatory Authorities 2000mg) by M/s Bowmed limited, MHRA Approved.
Me-too Status Trimark 500mg Injection by M/s WelMark pharmaceutical,
Reg. No. 69751
03/05/2019.
Aventek Pharma:
Brand Name +Dosage Form + Strength J-Cef 500mg IV Dry Powder Injection
2019
Type of Form Form-5
Me-too Status Trimark 500mg Injection by M/s WelMark pharmaceutical,
Reg. No. 69751
03/05/2019.
Aventek Pharma:

Brand Name +Dosage Form + Strength J-Cef 1g IV Dry Powder Injection
2019
Type of Form Form-5
Me-too Status Trimark 1000mg Injection by M/s WelMark
Pharmaceutical, Reg. No. 69752
03/05/2019.
Aventek Pharma:
Brand Name +Dosage Form + Strength Cefiderm 100mg/5ml Dry Powder Suspension
2019
Composition Each 5ml (reconstituted) Contains:
Type of Form Form-5
Pack Size & Demanded Price 30ml bottle, price As per SRO
Approval Status of Product in Reference Cefixime as trihydrate (100mg/5ml, 200mg/5ml,
Regulatory Authorities 500mg/5ml) by M/s Aurobindo, USFDA Approved.
Me-too Status Cefixima Dry Suspension 100mg of M/s Advanced
Pharmaceuticals, RCCI (Reg. # 065393)
03/05/2019.
Aventeck Pharma:
Brand Name +Dosage Form + Strength Cefiderm 200mg/5ml Dry Powder Suspension
2019

Composition Each 5ml (reconstituted) Contains:
Type of Form Form-5
Pack Size & Demanded Price 30 ml bottle, price As per SRO
Me-too Status Xerak Oral Dry Powder Suspension (200mg/5ml) by M/s
CKD, Reg. No. 81788
03/05/2019.
Aventeck Pharma:
Brand Name +Dosage Form + Strength Cefiderm 400mg Capsule
2019
Cefixime as Trihydrate….400mg
Type of Form Form-5
Approval Status of Product in Reference Suprax (cefixime as trihydrate) 400mg capsule by M/s
Regulatory Authorities Lupin ltd, USFDA approved.
Me-too Status Xalfocin 400mg Capsule by M/s Martin Dow (Reg. #
080646)
03/05/2019.
Aventeck Pharma:
Brand Name +Dosage Form + Strength J-Sum 1gm IV Dry Powder Injection
2019
Cefoperazone as Sodium…500mg
Type of Form Form-5

Approval Status of Product in Reference Sulperazon Injection, Pfizer Inc. PMDA Approved
Me-too Status 2Sum Injection 1g by M/s Sami Pharmaceuticals, Karachi
(Reg.# 047002)
03/05/2019.
Aventeck Pharma:
2019
Sulbactam as Sodium…1gm
Cefoperazone as Sodium…1gm
Pharmacological Group Cephalosporin/beta lactamase inhibitor
Type of Form Form-5
Approval Status of Product in Reference Approved by 3 European countries:
Regulatory Authorities Czech:
http://www.sukl.eu/modules/medication/detail.php?code=0
015
273&tab=info
Slovakia:
https://www.sukl.sk/hlavna-stranka/english-
version/specialpages/medical-product-
detail?page_id=842&lie_id=6343A
Poland:
http://pub.rejestrymedyczne.csioz.gov.pl/?AspxAutoDetect
CookieSupport=1#results
(Reg.# 047002)
03/05/2019.
Aventeck Pharma:

2019
Cefoperazone as Sodium…500mm
Pharmacological Group Cephalosporin/beta lactamase inhibitor
Type of Form Form 5
Approval Status of Product in Reference Sulperazon Injection, Pfizer Inc. PMDA Approved
(Reg.# 047002)
03/05/2019.
Aventeck Pharma:
1895. Name and address of manufacturer / M/s Reign Pharmaceuticals PCSIR-KLC Pvt Ltd.
Applicant TBIC Building-1, PCSIR Laboratories Complex, Shahrahe
Dr. Salim-us-Zaman Siddiqui, Off University Road,Karachi
Brand Name +Dosage Form + Strength Diraximin 200mg Tab
Diary No. Date of R& I & fee Dy.No 266 dated 09/11/2016 Rs.20,000
Duplicate file
The file is received from R-II section vide letter No.F.6-
10/2013-Reg-II dated 20/02/2020.
Rifaximin……200mg
Type of Form Form-5
Finished Product Specification In House
Approval Status of Product in Reference XIFAXAN® (rifaximin) 200mg film-coated tablets, for
Regulatory Authorities oral use. USFDA approved
Me-too Status Nimixa 200mg Tablet film-coated. Reg. No. 70734
GMP Status The panel dated 04-10-2019 recommends for renewal of
DML.
Decision: Approved with innovator’s specifications. The Board further decided that verification of
fee challan may be done as per decision of 285th meeting of Registration Board.
Applicant A-115, S.I.T.E, Super Highway, Karachi, Pakistan.
Brand Name +Dosage Form + Strength NS+20K Infusion 100ml
Diary No. Date of R& I & fee Dy.No 71 dated 10/09/2013 Rs.50,000 Dated 10-09-2013
Duplicate file
The file is received from R-I Section section vide letter
No.F.6-10/2013-Reg-II dated 20/02/2020.
Sodium chloride………..9mg
Potassium chloride…..150mg
Pharmacological Group Electrolytes
Type of Form Form-5
Pack Size & Demanded Price 100ml vial(as per SRO)
Approval Status of Product in Reference Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v
Regulatory Authorities Solution for Infusion – BP by M/s Baxter healthcare, MHRA
Approved. (strength is not same)
GMP Status Inspection date 28-06-2018, Good level of GMP
Remarks of the Evaluator. The applied product does not contain the same strength of
potassium chloride as the product contains approved by
reference regulatory authorities (RRAs). Provide evidence
of approval of the same formulation in same strength and
filled volume in RRAs as specified by Registration Board in
275th meeting or otherwise revise the formulation along with
the applicable fee.
evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) along with registration
 Evidence of approval of the same formulation in same strength and filled volume in
RRAs as specified by Registration Board in 275th meeting or otherwise revision of the
formulation along with the applicable fee.
Brand Name +Dosage Form + Strength Acbenzo 4% w/w Cream
Diary No. Date of R& I & fee Dy.No 1399 dated 13/01/2017 Rs.20,000 Dated 05-01-
2017
Duplicate file
The file is received from R-I Section vide letter No.F.6-
10/2013-Reg-II dated 20/02/2020.
Composition Each 100g cream contains:
Benzoyl Peroxide….4g
Type of Form Form-5
Approval Status of Product in Reference Brevoxyl 4% Cream by M/s GSK consumer healthcare,
Me-too Status Prayzid Cream 4% cream by M/s Pray Pharma, Reg. No. 72415
Decision: Approved. The Board further decided that verification of fee challan may be done as per
decision of 285th meeting of Registration Board.
Brand Name +Dosage Form + Strength Colonclean Syrup
Duplicate file
The file is received from R-I Section section vide letter
No.F.6-10/2013-Reg-II dated 20/02/2020.
Sodium potassium monobasic….2.4g
Potassium dibasic…………………….0.9g
Pharmacological Group Purgative
Approval Status of Product in Reference Could not be confirmed
Remarks of the Evaluator. evidence of approval of applied formulation in reference
meeting.
stability study data as per the guidelines provided in 278th
meeting of Registration Board is required.
 Evidence of approval of the same formulation in RRAs as specified by Registration
Board in 275th meeting or otherwise revision of the formulation along with the
applicable fee.
1899. Name and address of manufacturer / Manufacturer: M/s Synchro Pharmaceuticals.
Applicant 77-Industrial Estate, Kot Lakhpat, Lahore
Applicant: M/s Harmann Pharmaceutical Laboratories
(Pvt) Ltd , Lahore
Brand Name +Dosage Form + Strength Cewel Dry suspension 100mg/5ml
Differential fee 42,000/- dated 22/01/2015
Duplicate file
The application is received from R-II section vide letter no.
F.1-11/2019-Reg-II dated 24/12/2019.
Composition Each 5ml reconstituted suspension contains:
Cefixime Trihydrate equivalent to Cefixime…100mg
Type of Form Form 5
Me-too Status Cefixima Dry Suspension 100mg of M/s Advanced
Pharmaceuticals, RCCI (Reg. # 065393)
GMP Status Harmann Pharma: Decision of 272st Meeting of CLB:
I- Allow resumption of production activities in all sections
except Sterile Liquid Section of the firm M.s Harmann
Laboratories Lahore in as per recommendation of panel
inspection report dated 09-10-2019 in following sections.
a- Sterile Section-I (General Injection)
b- Sterile Section-III (Hormonal Injection)
II- Regularize the layout plan of Hormonal Section, as per
recommendations of the panel in the reort dated 13-06-2019
& 08-10-2019.
Synchro Pharma: Inspection report dated 30/06/2020. “it
was observed that firm had rectified most of the
shortcomings and for remaining shortcomings fir was
advised to submit CAPA within stipulated time and re-
inspection will be conducted accordingly”.
Remarks of the Evaluator. Copy of agreement is attached
The applicant has stated that there are no products being
manufactured on contract.
M/s Harmann Pharma has 7 approved sections.
Decision: Deferred for confirmation of required manufacturing facility “Dry Powder suspension
cephalosporin section” for applied formulation.
1900. Name and address of manufacturer / M/s Winthrox Laboratories Pvt Ltd.
Applicant K-219/A, S.I.T.E, Super Highway, Phase-II, Karachi,
Pakistan
Brand Name +Dosage Form + Strength Nystanil oral solution 100,000 units/ml
Diary No. Date of R& I & fee Dy.No 9908 dated 25/07/2017 Rs.20,000
Duplicate dossier
The application is received from R-I section vide letter no.
F.1-2/2019-Reg-I dated 01/01/2020.
Nystatin……100,000 units
Pharmacological Group antimycotic
Type of Form Form-5
Approval Status of Product in Reference Nystatin Oral Suspension BP by M/s Sandoz ltd, MHRA approved.
Me-too Status Nystrin Suspension 100,000/- per ml by M/s Harmann
Pharma, Reg. No. 28119
GMP Status 09-10-2018 Routine GMP Inspection “overall GMP
compliance level is rated as good.”
Liquid syrup section is available.
Remarks of the Evaluator.  The applied product is Oral Solution while the approved
product is reference country is Oral Suspension, provide
the evidence of approval in reference regulatory
authorities as approved by Registration Board in 275th
meeting or otherwise submit revised formulation as per
reference product along with the submission of applicable
fee.
 The firm has revised formulation the formulation from
Oral Solution to Oral Suspension as per the reference
product and submitted fee (Rs. 5,000/- challan number
1976772 dated 30/07/2020 + Rs. 15,000/- challan number
2034651 dated 09/09/2020).
Decision: Approved with the following details;
Brand name:
Nystanil oral suspension 100,000 units/ml
Label Claim:
Each ml contains:
Nystatin……100,000 units
Board further decided that verification of fee challan may be done as per decision of 285 th meeting
of Registration Board.
1901. Name and address of manufacturer / M/s Standpharm Pakistan Pvt. Ltd.
Applicant 20-km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Levra Injection 500mg/5ml
Diary No. Date of R& I & fee Dy.No 14122 dated 06-09-2017 Rs.20,000 Dated 06-09-
2017
Duplicate file
The application is received from R-II section vide letter
no.F.1-11/2019-Reg-II dated 24th December, 2019.
Type of Form Form 5
Pack Size & Demanded Price Rs. 325/- per ampoule
Approval Status of Product in Reference KEPPRA 500mg/5ml Injection of USFDA approved
Me-too Status Lumark Injection M/s Searle Pak
GMP Status GMP inspection dated 19-10-2017 satisfactory level of
compliance.
Injectable section available
Brand Name +Dosage Form + Strength Levra 100mg/ml Oral solution
2017
Duplicate file
Pharmacological Group antiepileptic
Type of Form Form 5
Pack Size & Demanded Price Rs 432/- per 60ml, Rs. 720/- per 120ml
Approval Status of Product in Reference LEVETIRACETAM (Levetiracetam100mg/ml)
Regulatory Authorities solution; oral By M/s TARO. USFDA Approved.
Me-too Status Levotam Oral solution 100mg/ml By M/s Platinum,
Karachi. (Reg.# 070837)
compliance.
Oral liquid section available
Brand Name +Dosage Form + Strength Oxepin Capsules 3/25mg
2017
Duplicate file
Olanzapine……………..3mg
Fluoxetine as HCl…….25mg
Pharmacological Group SSRI/Thienobenzodiazepine
Type of Form Form 5
Pack Size & Demanded Price Rs. 20/- per capsule
Approval Status of Product in Reference Symbyax 3mg/25 mg Capsules by Ms/ Eli Lilly, USA
Regulatory Authorities (USFDA approved).
Me-too Status Olanco Capsules by Genome Pharma. (Reg. # 079388)
compliance.
Capsule section available
1904. Name and address of manufacturer / Applicant: M/s Sapient Pharma, 123/S Quaid e Azam
Applicant Industrial Estate Kot Lakhpat , Lahore.
Manufacturer: M/s English Pharmaceutiacl Industries
Link kattar bund road, Thokar Niaz Baig, Multan road
Lahore.
Brand Name +Dosage Form + Strength Esomark 40mg Infusion
Lyophilized powder for infusion
2013
Duplicate file
11/2019-Reg-II dated 14/02/2020.
Esomeprazole as Sodium…..400mg
Type of Form Form 5
GMP Status English Pharma: Certificate of GMP Issued on 16-01-
2018.
Sapient Pharma: GMP certificate issued on 22/04/2020 on
Remarks of the Evaluator-I Copy of contact agreement is submitted,
5 sections of M/s Sapient Pharmaceutical Industries are
approved.
M/s Sapient Pharmaceutical Industries have 13 product
being manufactured on contract.
1905. Name and address of manufacturer / Applicant: M/s Sapient Pharma, 123/S Quaid e Azam
Applicant Industrial Estate Kot Lakhpat , Lahore.
Manufacturer: M/s English Pharmaceutiacl Industries
Link kattar bund road, Thokar Niaz Baig, Multan road
Lahore.
Brand Name +Dosage Form + Strength Biomep 40mg Infusion
Lyophilized powder for solution
2013
Duplicate file
11/2019-Reg-II dated 14/02/2020.
Omeprazole as sodium………40mg
Type of Form Form 5
GMP Status English Pharma: Certificate of GMP Issued on 16-01-
2018.
Sapient Pharma: GMP certificate issued on 22/04/2020 on
th
Remarks of the Evaluator-I Copy of contact agreement is submitted,
5 sections of M/s Sapient Pharmaceutical Industries are
approved.
M/s Sapient Pharmaceutical Industries have 13 product
being manufactured on contract.
1906. Name and address of manufacturer / M/s Wimits Pharmaceuticals (Pvt.) Ltd.
Lahore
Brand Name +Dosage Form + Strength Phlocin Injection
Diary No. Date of R& I & fee Dy.No 485 dated 21-03-2014 Rs.20,000
Duplicate file
11/2019-Reg-II.
Phloroglucinol hydrate….….40mg
Trimethylphloroglucinol…..0.04mg
Pharmacological Group Antispasmodic.
Type of Form Form-5
Approval Status of Product in Reference Spasfon injection by M/s Teva Health (ANSM) France
Regulatory Authorities Approved (4 ml glass ampoule)
Me-too Status Spasrid Injection of Barrett Hodgson Pakistan (Pvt) Ltd
(Reg.# 034744)
GMP Status GMP certificate issued on 10/12/2018 on the basis of
Liquid injectable section available
1907. Name and address of manufacturer / M/s Alina Combine Pharmaceuticals Pvt Ltd
Applicant A-127, S.I.T.E Super Highway, Karachi
Brand Name +Dosage Form + Strength Florlina Plus powder
Duplicate file
Neomycin Sulphate….…15gm
Florfenicol…………………..10gm
Oxytetracycline Hcl……..30gm
Type of Form Form-5
Pack Size & Demanded Price 100gm, 200gm 500gm, 1kg, price decontrolled
Me-too Status NEOXFLOR ORAL POWDER (150mg, 100mg 300mm per
gram) by M/s Baariq Pharma, Reg. No. 088638
GMP Status
Decision: Deferred for updated status of GMP from QA & LT division.
1908. Name and address of manufacturer / M/s Alina Combine Pharmaceuticals Pvt Ltd
Applicant A-127, S.I.T.E Super Highway, Karachi
Brand Name +Dosage Form + Strength Enflox-c plus liquid
Diary No. Date of R& I & fee Dy. No 13 dated 01-07-2015 Rs.20,000 Dated 30-06-2015
Duplicate file

Enrofloxacin………..…10mg
Cloistin sulphate…….100mg
Amantadine HCl…..…300gm
Type of Form Form-5
Pack Size & Demanded Price 100ml, 200ml, 500ml, 1000ml, price decontrolled
GMP Status Evidence of GMP is required.
Updated status of GMP from QA & LT division.
Evidence of applied formulation/drug already approved by DRAP (generic/me-too status)
alongwith registration number, brand name & name of firm.
Brand Name +Dosage Form + Strength Colate powder for solution for injection
2018 (Duplicate file)
Composition Each vial contains;
Colistimethate sodium….…….1MIU (eq. to 80mg)
Type of Form Form 5
Approval Status of Product in Reference Promixin, 1 million International Units (IU), Powder for
Regulatory Authorities Solution for Infusion, which is approximately equivalent to
80 mg of colistimethate sodium by M/s Zambon S.p.A.,
MHRA Approved.
Me-too Status Colistat powder for Injection 1MIU by M/s Medisure Lab
(Reg#076160)
GMP Status Date of inspection 10/04/2019, acceptable level of cGMP
compliance
1910. Name and address of manufacturer / M/s Pharmix Laboratories Pvt Ltd.
Applicant 21 Km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Janumet tablet
Duplicate file
Sitagliptin…….……..50mg
Metformin HCl……..500mg
Type of Form Form 5
Pack Size & Demanded Price Rs. 1,500/- per pack of 2×7’s
Approval Status of Product in Reference Janumet film coated tablet (50mg/500mg & 50mg/1000mg)
Regulatory Authorities 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 Status The firm has submitted the correct composition as per
the reference product given in the following without
submission of any fee.

Sitagliptin as phosphate monohydrate……..50mg
Metformin HCl…………………………….500mg
Decision: Deferred for submission of requisite fee for revision of formulation as per reference
product.
1911. Name and address of manufacturer / M/s Wilshire Laboratories Pvt Ltd.
Applicant 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat,
Lahore
Brand Name +Dosage Form + Strength Relspasm Injection 4mg/2ml
Diary No. Date of R& I & fee Dy.No 749 (10/02/2020)
Dated of submission: 04/06/2011
Fee: 8,000(02/06/2011)+12,000(14/01/2015)
Duplicate file
11/2019-Reg-II dated 12/02/2020.
Dated 09-01-2015
Thiocolchicooside………2mg
Type of Form Form-5
Approval Status of Product in Reference Coltramyl Injection by M/s Sanofi Aventis (ANSM
Regulatory Authorities France)
Me-too Status Myolax 2mg Injection (4mg/2ml ampoule) by M/s Saffron,
Reg. no. 60355
Liquid injectable section is available.
1912. Name and address of manufacturer / M/s Wilshire Laboratories Pvt Ltd.
Applicant 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat,
Lahore
Brand Name +Dosage Form + Strength Derams Injection 500mg IV
Powder for solution
Diary No. Date of R& I & fee Dy.No 748 (10/02/2020)
Dated of submission: 04/06/2011
Fee: 8,000(03/06/2011)+12,000(16/12/2014)
Duplicate file
11/2019-Reg-II dated 12/02/2020.
Dated 09-01-2015
Thiopental sodium…500mg (as a mixture of Thiopental
sodium and sodium carbonate)
Pharmacological Group Genera anesthetic
Type of Form Form-5
Approval Status of Product in Reference Thiopental Sodium 500mg Powder for Solution for Injection by M/s
Regulatory Authorities Kyova kirin ltd, MHRA Approved.
Me-too Status M-Pentone 500mg Injection by M/s Mediate, Reg. No. 61946

Dry powder injectable section is available.
Decision: Deferred for clarification of method of manufacturing of the applied product whether
via lyophilization or dry powder filling alongwith reference / innovator’s product manufacturing
method.
1913. Name and address of manufacturer / M/s Vision Pharmaceuticals.
Applicant Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Glunate injection 250mg
Powder for injection
Duplicate file
Hydrocortisone as sodium succinate………250mg
Pharmacological Group Glucocorticoid-Minerolcorticoid
Type of Form Form-5
Approval Status of Product in Reference Hydrocortisone as sodium succinate Injection-USFDA
Me-too Status Solu-cortef by Pfizer Pharma
GMP Status Date of inspection 11-02-2019, good level of GMP as of
today.
Decision: Deferred for confirmation of required manufacturing facility/section approval from
Licensing division.
1914. Name and address of manufacturer / M/s Zakfas pharmaceutical pvt Ltd. 12-Km, bosan raod,
Applicant multan.
Brand Name +Dosage Form + Strength Gen-One topical spray
Diary No. Date of R& I & fee y.No 546 dated 09-06-2016 Rs.50,000 Dated 09-06-2016
Gentamicin as sulphate………….0.57mg
Betamethasone as valerate……0.284mg
Pharmacological Group Antibiotic/corticosteroid
GMP Status
Remarks of the Evaluator. Section approval letter.
GMP inspection report
International availability.
Stability required.
Decision: Deferred for following;
 Required manufacturing facility/section approval from Licensing Division.
 Latest GMP inspection report.
1915. Name and address of manufacturer / M/s Reliance Pharma.
Applicant Plot No 8, Street No. S-8, Industrial Estate, Rawat,
Islamabad
Brand Name +Dosage Form + Strength Exelor 50mg tablet
2017
Composition Each film coat tablet contains:
Vildagliptin……..50mg
Pharmacological Group Antihyperglycemic agent
Type of Form Form-5
th
Approval Status of Product in Reference GALVUS (Vildagliptin 50 mg tablets un-coated) by
Regulatory Authorities Novartis Pharmaceuticals Australia Pvt Ltd. TGA
approved
Me-too Status V- Glip 50mg uncoated tablet of M/s Wellborne Pharma
(Reg. # 080908)
GMP Status Inspection date, 27/12/2018, the firm is working in
compliance to GMP standards.
Remarks of the Evaluator-I The firm has revised the formulation from Film Coated to
Uncoated Tablet with submission of Rs. 5000/- challan no.
1938304 dated 08/12/2019 as per the reference product
given in the following;
Each Tablet contains:
Vildagliptin……..50mg
Decision: Approved with innovator’s specifications
1916. Name and address of manufacturer / M/s Derma Techno Pakistan, Plot No. 528 Sundar Industrial
Applicant Estate Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Azocin 250mg tablet
Diary No. Date of R& I & fee Dy.No dated 24/05/2011 Rs.8000/- Dated 24/05/2011
Rs. 20,000/- 20/02/2013 (slip no.
Duplicate file
11/2019-Reg-II dated 01/06/2020.
Azithromycin as dihydrate……250mg
Pharmacological Group Antiobiotic
Type of Form Form-5
Pack Size & Demanded Price Rs. 150/- per 6’s
Approval Status of Product in Reference MHRA Approved
Me-too Status "Ery-Pack Tablets " Lowitt Pharmaceutical (Pvt)
Ltd,Plot.No.24 Industrial Estate, Peshawar." Reg. No.
068269
GMP Status GMP inspection conducted on 21-05-18 & 05-07-18
concluded that firm has maintained conformance to GMP
in the manufacturing and quality control operations on the
day of inspection.
Decision: Deferred for submission of evidence of approval of applied formulation as “uncoated
tablets” in reference regulatory authorities/agencies which were adopted by the Registration Board
1917. Name and address of manufacturer / M/s Derma Techno Pakistan, Plot No. 528 Sundar Industrial
Applicant Estate Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Azocin 500mg tablet
Diary No. Date of R& I & fee Dy.No dated 24/05/2011 Rs.8000/- Dated 24/05/2011
Rs. 20,000/- 20/02/2013
Duplicate file
11/2019-Reg-II dated 01/06/2020.
Azithromycin as dihydrate……500mg
Type of Form Form-5
Pack Size & Demanded Price Rs. 275/- per 6’s
Approval Status of Product in Reference MHRA Approved
Me-too Status "Ery-Pack Tablets " Lowitt Pharmaceutical (Pvt)
Ltd,Plot.No.24 Industrial Estate, Peshawar." Reg. No.
068269
GMP Status GMP inspection conducted on 21-05-18 & 05-07-18
concluded that firm has maintained conformance to GMP in
the manufacturing and quality control operations on the day
of inspection.
Decision: Deferred for submission of evidence of approval of applied formulation as “uncoated
tablets” in reference regulatory authorities/agencies which were adopted by the Registration Board
1918. Name and address of manufacturer / Applicant: M/s Global Pharmaceuticals, Plot No. 204-205,
Applicant Industrial Triangle, Kahuta road, Islamabad.
Manufacturer: M/s Vision Pharmaceuticals, Plot No. 22-
Contract manufacturing 23, Industrial triangle, Kahuta road, Islamabad.
Brand Name +Dosage Form + Strength Glonate Injection 250mg
Diary No. Date of R& I & fee Dy.No 166 dated 03/11/2016 Rs.20,000/- dated 02/11/2016
+ Rs. 30,000/- 10/11/2016
Duplicate file
Hydrocortisone sodium succinate…….250mg
Type of Form Form 5
Approval Status of Product in Reference Solu-Cortef Act-O-Vial (100mg,250mg,500mg) powder for
Regulatory Authorities injection by M/s Pfizer, MHRA Approved.
Me-too Status Cortizone 250mg Injection by M/s Vision Pharmaceuticals,
Reg. No. 81899
GMP Status Global Pharma: Inspection date 26/12/2018, panel
Remarks of the Evaluator. Clarification is required since the product approved in
reference country contains “Hydrocortisone as sodium
succinate 250” while the label claim of the applied product
is “Hydrocortisone sodium succinate 250mg”.
Form 5 is submitted by the manufacturer while it should be
submitted by the applicant.
Detail of number of products being manufactured for M/s
Global Pharmaceuticals is required.
Provide number of approved sections of M/s Global
Pharmaceuticals.
Decision: Deferred for submission of the followings;
 Evidence of approval of applied formulation containing “Hydrocortisone sodium succinate
250mg” in reference regulatory authorities/agencies which were adopted by the Registration
 Form 5 is submitted by the manufacturer while it should be submitted by the applicant.
 Detail of number of products being manufactured for M/s Global Pharmaceuticals is required.
 Provide number of approved sections of M/s Global Pharmaceuticals.
1919. Name and address of manufacturer / M/s Metro Pharmaceuticals, Plot # 14, street No. SS-2,
Brand Name +Dosage Form + Strength Sitavin 50mg/1000mg Tablets
Diary No. Date of R& I & fee Dy. No. 40986 dated 06/12/2018 Fee Rs. 20,000/-
Sitagliptin as phosphate monohydrate……50
Metformin HCL ………………………1000mgs
Type of Form Form 5
Approval Status of Product in Reference Janumet film coated tablet (50mg/500mg &
Regulatory Authorities 50mg/1000mg) by M/s MSD, USFDA Approved.
Me-too Status Sitaglip-Plus Tablet 50/1000 by M/s Maple
GMP Status Last inspection report dated 22/05/2018, the firm is
operating with cGMP as of today.
1920. Name and address of manufacturer / M/s Metro Pharmaceuticals, Plot # 14, street No. SS-2,
Brand Name +Dosage Form + Strength Sitavin 50mg/1000mg Tablets
Sitagliptin as phosphate monohydrate……50
Metformin HCL ………………………500mg
Type of Form Form 5
Approval Status of Product in Reference Janumet film coated tablet (50mg/500mg &
Regulatory Authorities 50mg/1000mg) by M/s MSD, USFDA Approved.
Me-too Status Sitaglip-Plus Tablet 50/500 by M/s Maple
1921. Name and address of manufacturer / M/s Metro Pharmaceuticals,
Applicant Plot # 14, street No. SS-2, National Industrial Zone,
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Demant 5mg tablet
Memantine Hydrochloride…5mg
Pharmacological Group antiparkinson
Type of Form Form 5
Approval Status of Product in Reference Memantine Torrent 5mg Film-coated Tablets by M/s
Regulatory Authorities Torrent Pharma (UK) Ltd, MHRA Approved.
Me-too Status Afdol 5mg Tablets by M/s AGP (R # 047166)
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Demant 10mg tablet
Memantine Hydrochloride…10mg
Pharmacological Group antiparkinson
Type of Form Form 5
Approval Status of Product in Reference Memantine Accord (5mg, 10mg, 15mg, 20mg) film-
Regulatory Authorities coated tablets by M/s Accord, MHRA Approved.
Me-too Status Afdol 10mg Tablets by M/s AGP (R # 044429)
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength M-Rox tablet 250mg
Valproic acid (as Divalproex Sodium)….250mg
Type of Form Form 5
Approval Status of Product in Reference Depakote 250mg Gastro-resistant tablet by M/s Aventis
Regulatory Authorities Pharma Limited (MHRA Approved)
Me-too Status Epinil 250mg Tablets by M/s Platinum Pharmaceuticals
(Pvt) Ltd (Reg#024464)
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength M-Rox tablet 500mg
Valproic acid (as Divalproex Sodium)….500mg
Type of Form Form 5
Approval Status of Product in Reference Depakote (250mg, 500mg) Gastro-resistant tablet by M/s
Regulatory Authorities Aventis Pharma Limited (MHRA Approved)
Me-too Status Epinil 500mg Tablets by M/s Platinum Pharmaceuticals
(Pvt) Ltd (Reg#024465)
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Sezgol Tablet 20mg
Esomeprazole as magnesium trihydrate……20mg
Type of Form Form 5
Approval Status of Product in Reference Nexium (20mg, 40mg) gastro-resistant tablets by M/s
Regulatory Authorities AstraZeneca UK Limited,MHRA Approved.
Me-too Status Nexum 20mg tablet by M/s Getz Pharma, Reg. No. 33430
Decision: Approved with innovatpr’s specifications.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Sezgol Tablet 40mg
Esomeprazole as magnesium trihydrate……40mg
Type of Form Form 5
Approval Status of Product in Reference Nexium (20mg, 40mg) gastro-resistant tablets by M/s
Regulatory Authorities AstraZeneca UK Limited,MHRA Approved.
Me-too Status Nexum 40mg tablet by M/s Getz Pharma, Reg. No. 33431
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Omefit 40mg Capsules
Omeprazole enteric coated pellets…40mg
Type of Form Form 5
Approval Status of Product in Reference Losec Capsule (20mg, 40mg) by M/s Astra Zaneca
Regulatory Authorities (MHRA Approved)
Me-too Status Meprascot Capsules 40mg by M/s Scotmann
Remarks of the Evaluator. Source= Vision Pharma,
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Tino CR tablet 25mg

Contains:
Paroxetine as HCl……..25mg
Type of Form Form 5
Pack Size & Demanded Price as per SRO
Approval Status of Product in Reference Paxil CR 25mg Tablet by M/s Apotex Technologies
Regulatory Authorities USFDA Approved)
Me-too Status Paroxin CR Tablets 25mg by M/s Shrooq
pharmaceuticals (Reg#060470).
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Tino CR tablet 12.5mg
Contains:
Paroxetine as HCl……..12.5mg
Type of Form Form 5
Approval Status of Product in Reference Paxil CR 12.5mg Tablet of M/s Apotex Technologies
Regulatory Authorities (USFDAApproved)
Me-too Status Panox CR Tablet 12.5mg of M/s Regal Pharma
(Reg.#081953)
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength A-O tablet 10mg/20mg
Amlodipine as Besylate…………10mg
Olmesartan Medoxomil…………20mg
Type of Form From 5
Finished Product Specification MFG specs
Approval Status of Product in Reference Amlodipine and Olmesartan Medoxomil 10/20mg film
Regulatory Authorities coated tablet by M/s Torrent USFDA Approved.
Me-too Status Omsana-AM 10/20 Tablet by M/s HiltonPharma (Pvt.)
Limited, Reg. No. 58559
Applicant
Plot # 14, street No. SS-2, National Industrial Zone,
Rawat, Islamabad.
Brand Name +Dosage Form + Strength A-O tablet 5mg/20mg
Amlodipine as Besylate…………5mg
Olmesartan Medoxomil…………20mg
Type of Form From 5
Finished Product Specification MFG specs
Approval Status of Product in Reference Sevikar film-coated tablets (20mg/5mg, 40mg/5mg,
Regulatory Authorities 40mg/10mg) by M/s DAIICHI SANKYO UK Limited,
MHRA Approved.
Me-too Status Omsana-AM 5/20 Tablet by M/s HiltonPharma (Pvt.)
Limited, Reg. No. 58557
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Metlipsy 800mg tablet
Piracetam…800mg
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form 5
Approval Status of Product in Reference Piracetam 800mg film-coated tablet by M/s USB
Regulatory Authorities Pharma, MHRA approved
Me-too Status Nootropil Tablet 800mg by M/s GSK Reg. No. 82277
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Mydin 10mg Tablet
Loratadine……..10mg
Type of Form Form 5
Approval Status of Product in Reference Roletra 10 mg Tablets by M/s Ranbaxy (UK) Limited.
Me-too Status Senergy OD 10mg tablet by M/s Highnoon
(Reg.#017672)
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Rovas 20mg Tablet
Rosuvastatin as calcium..…20mg
Type of Form Form 5
Approval Status of Product in Reference Crestor (rosuvastatin as calcium) (5mg, 10mg, 20mg,
Regulatory Authorities 40mg) film coated tablet by M/s IPR, USFDA Approved.
Me-too Status Rosulin Tablets 20mg tablet by M/s ' Highnoon
Laboratories, Reg. no. 48371
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Rovas 40mg Tablet
Rosuvastatin as calcium..…40mg
Type of Form Form 5
Approval Status of Product in Reference Crestor (rosuvastatin as calcium) (5mg, 10mg, 20mg,
Regulatory Authorities 40mg) film coated tablet by M/s IPR, USFDA Approved.
Me-too Status Aurora Tablets 40mg by M/s Ferozsons Laboratories,
Reg. no. 54747
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Relaxer tablet 4mg
Thiocolchicoside ………4mg
Pharmacological Group Anti Parkinson, neuralgia
Type of Form Form 5
Approval Status of Product in Reference THIOCOLCHICOSIDE EG 4 mg, scored tablet. ANSM
Regulatory Authorities France approved
Me-too Status Myolax Tablets 4mg by M/s Reko Pharma Reg. No.
74170
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Konaz cream 2% w/w
Ketoconazole… 20mg (2% w/w)
Type of Form Form 5
Approval Status of Product in Reference Daktarin Gold 2% Cream by M/s McNeil Products
Regulatory Authorities Limited, MHRA Approved.
Me-too Status Bizrole Cream 2 % by M/s Searle IV Solutions (Pvt.) Ltd,
Reg. No. 78620
Ointment/cream/gel/lotion (non-steroidal) section is
approved.
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Binaf Cream 1% w/w
Composition Each Gram of cream contains:
Terbinafine as HCl ……..10mg (1%)
Pharmacological Group Anti fungal
Type of Form Form 5
Approval Status of Product in Reference Terbinafine HCl 1% cream by M/s Taro, USFDA
Me-too Status Terbisan caream 1% by M/s Elko organization (PvT) ltd.
Reg # 27076
Ointment/cream/gel/lotion (non-steroidal) section is
approved.
Decision: Approved.
Rawat, Islamabad.
Brand Name +Dosage Form + Strength Metacid Oral Suspension
Aluminium hydroxide…….215mg
Magnesium hydroxide…….80mg
Simethicone……………….25mg
Pharmacological Group Antacid
Type of Form Form 5
Approval Status of Product in Reference Could not be verified
Me-too Status Simecrol Suspension by M/s Hicon Pharmaceuticals
(Reg.#041458)
b. Deferred Cases (Local manufacturing) Human

1940. Name and address of manufacturer / Manufactured by:
Applicant M/s Medicaids Pakistan (pvt) ltd. Plot # 10, Sector 27,
Korangi Industrial Area Karachi.
Contract manufacturing Manufactured for (Applicant):
M/s Inventor Pharma. Plot No..K-196, SITE (SHW)
Phase II, Karachi. (8 sections)
Brand Name +Dosage Form + Strength MAXI Eye Drops
(Opthalmic Solution)
Composition Each ml of suspension contains:
Moxifloxacin as HCl…….5mg
Pharmacological Group Anti-infective/Corticosteroids
Type of Form Form 5
Approval Status of Product in Reference MOXIVIG 0.5%w/v eye drops, solution by M/s Novartis
Regulatory Authorities Pharmaceuticals UK Limited, MHRA Approved.
Me-too Status Ocumox-D Eye Drops by M/s Remington Pharmaceutical
Industries, Reg No. 67888
GMP Status GMP certificate issued on basis of inspection conducted on
09/08/2018.
Remarks of the Evaluator. The firm has revised the formulation from ophthalmic
suspension to ophthalmic solution and submitted Rs.
5000/- vide Callan number 1909480 dated 29/11/2019.
The applicant has 08 sections.
The firm has submitted that they are not having any
registration on the basis of contract manufacturing.
Decision of 293rd meeting: Deferred for submission of differential fee of Rs. 45000/- for revision of
formulation from “Opthalmic suspension” to Opthalmic solution”.
Submission by the firm:
The firm has submitted differential fee of Rs. 45,000/- vide challan number 2035976 dated
02/09/2020 for revision of formulation from Opthalmic suspension to Opthalmic solution as per the
reference product. The correct label claim is given in the following;
Each ml contains:
Moxifloxacin as HCl…….5mg
(Opthalmic solution)
Decision: Approved.
1941. deleted

Phase II, Karachi.
Brand Name +Dosage Form + Strength KATS sterile ophthalmic solution

Ketorolac Trimethamine………5mg
Type of Form Form 5
Finished Product Specification MFG
Approval Status of Product in Reference Ketorolac trometamol 0.5% w/v eye drops, solution by M/s
Regulatory Authorities Brown & Burk UK Ltd,MHRA Approved.
Me-too Status Ketro 0.5% Eye Drops by Ms/ Vega Pharmaceuticals (Pvt)
Ltd, Reg No. 54030
09/08/2018.
Remarks of the Evaluator. The firm has claimed In-House manufacturing
specifications and the product is not present in available
The firm has revised the formulation of the applied
product from ophthalmic suspension to ophthalmic
solution and submitted Rs. 5000/- vide challan number
1909484 dated 29/11/2019.
Each ml contains:
Ketorolac Tromethamine………5mg
Phase II, Karachi.
Brand Name +Dosage Form + Strength PATLERG sterile ophthalmic solution
Olopatadine as HCl……..1mg
Type of Form Form 5
Approval Status of Product in Reference Olopatadine 1 mg/ml Eye drops, Solution by M/s Brown & Burk
Regulatory Authorities UK Ltd, MHRA Approved.
Me-too Status Zolopat 0.5% eye drops by Ms/ Remington Pharmaceutical
Industries, Reg. No. 065991
09/08/2018.
suspension to ophthalmic solution along with the
submission of Rs. 5000/- vide challan number 1909483
dated 29th/11/2019.

Each ml contains:
Decision: Approved.
Phase II, Karachi.
Brand Name +Dosage Form + Strength PATLERG FORTE Sterile ophthalmic solution
Type of Form Form 5
Approval Status of Product in Reference OLOPATADINE HYDROCHLORIDE 0.2% opthalmic solution by M/s
Regulatory Authorities CIPLA, USFDA Approved.
Me-too Status Plop Forte Ophthalmic solution 2mg/ml by M/s Genix
Pharma, Reg. No. 73680
09/08/2018.
suspension to ophthalmic solution along with the
submission of Rs. 5000/- vide challan number 1909482
dated 29th/11/2019.
Each ml contains:
Decision: Approved.
1945. Name and address of manufacturer / Applicant: M/s Winlet Pharmaceuticasl, 30-km, Lakisa
Applicant Lahore-Sargodha road, Sargodha.
Manufacturer: M/s Biolabs (pvt) Ltd., Plot # 145, Industrial
Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Omezole 40mg Injection IV
Strength
Composition Each vial vontains:
(Lyophilized powder)
Type of Form Form 5
Approval Status of Product in Omeprazole 40mg Powder for Solution for Infusion by M/s
GMP Status Biolabs: Last GMP inspection was conducted on 23-04-2019
and the report concludes a reasonably acceptable GMP
compliance.
Winlet Pharma: The firm is granted New Drug
Manufacturing License based on inspection Dated 05-12-
2017.
Firm has informed that the applicant firm has 4 approved
sections and they have no product already registered on
Decision of 295th meeting: Deferred for confirmation of manufacturing method (powder filling or
lyophilization) and requisite facility.
Submission of the firm:
The firm has submitted that the product would be manufactured by way of Lyophilization at approved
facility of Bio-labs (pvt) ltd. Section approval letter no. F.1-12/89-Lic(Vol-II) dated 23rd July, 2012 for
Lyophilized vials (General) is provided.
Decision: Deferred for confirmation of method of manufacturing (lyophilization or dry powder
filling) from initially submitted application/dossier.
Brand Name +Dosage Form + Lorno 8mg for Injection IV/IM
Strength
Composition Each Vial contains:
Lornoxicam………8mg
(Lyopilized powder)
Type of Form Form 5
Approval Status of Product in Xefo 8 mg powder and solvent for solution for injection
Reference Regulatory Authorities by M/s Takeda Austria GmbH, (Austria Approved)
Me-too Status Viltaz Injection 8mg/2ml by Wilshire (Reg. No. 077112)
compliance.
2017.
Decision of 295th meeting: Deferred for following:

a. Confirmation whether application is by lyophilization process or powder filling.
b. Registration status of M/s Biolab for same formulation.

a. The firm has submitted that the product would be manufactured by way of Lyophilization at
approved facility of Bio-labs (pvt) ltd. Section approval letter no. F.1-12/89-Lic(Vol-II) dated 23rd July,
2012 for Lyophilized vials (General) is provided.
b. M/s Biolabs Pvt ltd does not have the registration of the applied formulation.
Brand Name +Dosage Form + Esozole 40mg Injection IV
Strength
(Lyophilized powder of Esomeprazole sodium)
Type of Form Form 5
Approval Status of Product in Nexium IV 40mg/vial injection by M/s ASTRAZENECA
Reference Regulatory Authorities PHARMS (USFDA approved)
compliance.
2017.
facility of Bio-labs (pvt) ltd. Section approval letter no. F.1-12/89-Lic(Vol-II) dated 23rd July, 2012 for
Lyophilized vials (General) is provided.
1948. Name and address of manufacturer "M/s Usawa Pharmaceuticals. 146 S.I.Z. Risalpur, KPK,
/ Applicant Pakistan
By
Road, Islamabad"
Brand Name +Dosage Form + Awablock 40mg Injection
Strength
Composition "Each Vial Contains:
Esomeprazole……40mg"
Diary No. Date of R& I & fee Dy. No 11728 dated 30-03-2018 Rs.50,000/- Dated 29-03-
2018
Type of Form Form 5

Approval status of product in Approved by USFDA
Me-too status (with strength and Nexum IV 40mg Injection by M/s Getz Pharma, Karachi,
dosage form) (Reg#050651)
GMP status Last inspection dated 18 & 23-04-2019 concluded acceptable
level of GMP compliance
Remarks of the EvaluatorII
The firm has submitted that the product would be manufactured by way of Lyophilization at
approved facility of Bio-labs (pvt) ltd. Section approval letter no. F.1-12/89-Lic(Vol-II) dated 23rd
July, 2012 for Lyophilized vials (General) is provided.
The firm has applied for Esomeprazole 40mg while reference product contains Esomeprazole as
sodium 40mg.
1949. Name and address of manufacturer / Paramount Pharmaceuticals, 36-Industrial Triangle,
Manufactured by
Bio Labs (Pvt) Ltd, Plot #, Industrial Triangle, Kahuta
Road Islamabad
Brand Name +Dosage Form + Strength EPI 40mg Injection
Composition Each vial contain:
Esomeprazole (as Sodium)........40mg
Diary No. Date of R& I & fee Dy. No. 5781 Date:29-08-2016 Rs. 50,000/-
Type of Form Form 5
Finished product Specifications Manufacturer spec
Pack size & Demanded Price 1’s : As per PRC
Approval status of product in Nexium I.V. 40mg of (MHRA approved)
Me-too status (with strength and Esold Injection of M/s Weather Folds Pharmaceutical
dosage form)
GMP status Last inspection of Bio-Labs conducted on 05-12-2017 & 06-
12-2017 and report concludes that firm is found at fair level
of GMP compliance
Previous Remarks of the Evaluator IV Contract agreement attached
Number of already registred contract manufactured
products: Nil
Registration Board deferred the case for assessment and
confirmation of manufacturing capacity of M/s Biolabs by
panel to be constituted by Chairman Registration Board for
further granting contract manufacturing permission as the
firm has already been granted approval for contract
manufacturing of numerous products (M-282)
Evaluation by PEC Registration Board discussed the inspection report in
details. Deliberations were made on used and available
capacity keeping in view registered product, currently
applied products and future products. After thorough
deliberation, the Board decided to allow contract
manufacturing from M/s Bio-Labs (Pvt) Ltd. Plot No.145
Industrial Triangle, Kahuta Road, Islamabad for
following sections:
 Dry Suspension (Cephalosporin)
 Capsule (Cephalosporin)
 Dry vial injectable (Cephalosporin)
 Lyophilized vial injectable (General)
Decision of 295th meeting: Registration Board deferred the case for confirmation of dry powder vial
filling facility.
facility of Bio-labs (pvt) ltd. Section approval letter no. F.1-12/89-
Lic(Vol-II) dated 23rd July, 2012 for Lyophilized vials (General) is provided.
1950. Name and address of manufacturer/ M/s Alen Pharmaceuticals Pvt Ltd. 138-Nowshera
Applicant Industrial, Risalpur, KPK. by M/s Bio Labs Pvt Ltd.Plot #
145, Industrial Triangle, Kahuta Road, Islamabad
Brand Name + Dosage Form + Strength Winlor 8mg Injection
Lornoxicam…8mg
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
Approval status of product in Reference XEFO 8 mg powder and solvent for solution for injection.
Biolab: The firm was inspected on 18 & 23.04.2019 with
the following conclusion:
operating at a reasonably acceptable compliance with GMP
as of today as per the Drugs Act, 1976 and Drap, Act, 2012
Remarks of the Evaluator The firm submitted list of 03 products registered for
th
Decision of 295 meeting: Deferred for following:
 confirmation of manufacturing requirement of product, facility by manufacturer and also
whether firm is manufacturing for itself or otherwise.
a. The firm has submitted that the product would be manufactured by way of Lyophilization at
approved facility of Bio-labs (pvt) ltd. Section approval letter no. F.1-12/89-
Lic (Vol-II) dated 23rd July, 2012 for Lyophilized vials (General) is provided.
b. M/s Biolabs Pvt ltd does not have the registration of the applied formulation.
c. The firm has submitted receiving of submission of application for Renewal of DML on 18 th Sep,
2019. Renewal of DML is due from 16/09/2019.
Confirmation of method of manufacturing (lyophilization or dry powder filling) from initially
submitted application/dossier.
Confirmation of DML status of M/s Alen Pharmaceuticals pvt. Ltd, Risalpur.
1951. Name and address of manufacturer / M/s Bio-Mark Pharmaceuticals, 527 Sundar Industrial
Applicant Estate, Lahore contract manufactured by M/s Bio-Labs
(pvt) Ltd, Plot # 145, Industrial Triangle, Kahuta Road,
Islamabad.
Brand Name +Dosage Form + Strength BIMEP 40MG INJECTION IV

Omeprazole (as sodium)…………..40mg
Type of Form Form-5
Pack size & Demanded Price 1’s vial; As recommended by the PRC
Approval status of product in Omeprazole 40mg powder for solution for injection of
Reference Regulatory Authorities. Sandoz, UK (MHRA)
Me-too status Zegrid-40 Injection of Shaigan Pharma
GMP status The firm M/s Biolabs was granted GMP certificate based
on inspection conducted on 5th & 06th December, 2017
Previous decision(s) Deferred due to capacity constraint in “Dry Vial
(Cephalosporin) Injection of M/s Bio-Labs (Pvt.) Ltd, Plot #
145, Industrial Triangle, Kahuta Road, Islamabad (M-291).
Evaluation by PEC The firm has submitted that now M/s. Bio-Lab Pvt. Ltd has
enhanced its capacity.
Previous decision (M-293) Deferred for confirmation of manufacturing method (powder
filling or lyophilization) and requisite facility.
Evaluation by PEC The product would be manufactured by way of
Lyophilization at approved facility of Bio-labs (pvt) ltd. M/s
Biolabs has been granted the relevant section for
lyophilization vide letter no. F.1-12/89-
Lic(Vol-II) dated 23rd July, 2012.
1952. Name and address of manufacturer / M/s Bio-Mark Pharmaceuticals, 527 Sundar Industrial
Applicant Estate, Lahore contract manufactured by M/s Bio-Labs
(pvt) Ltd, Plot # 145, Industrial Triangle, Kahuta Road,
Islamabad.
Brand Name +Dosage Form + Strength NULOC 40MG INJECTION IV
Esomeprazole (as sodium)…………..40mg
Type of Form Form-5
Pack size & Demanded Price 1’s vial; As recommended by the PRC
Approval status of product in Nexium IV 40mg powder for solution for injection
Reference Regulatory Authorities. of AstraZeneca, UK (MHRA)
Me-too status Somezol Injection of Bosch, Karachi
GMP status The firm M/s Biolabs was granted GMP certificate based
on inspection conducted on 5th & 06th December, 2017
Previous decision(s) Deferred due to capacity constraint in “Dry Vial
(Cephalosporin) Injection of M/s Bio-Labs (Pvt.) Ltd, Plot #
145, Industrial Triangle, Kahuta Road, Islamabad (M-291).
Evaluation by PEC The firm has submitted that now M/s. Bio-Lab Pvt. Ltd has
enhanced its capacity.
Previous decision (M-293) Deferred for confirmation of manufacturing method (powder
filling or lyophilization) and requisite facility.
Firm’s response The product would be manufactured by way of
Lyophilization at approved facility of Bio-labs (pvt) ltd. M/s
Biolabs has been granted the relevant section for

lyophilization vide letter no. F.1-12/89-
Lic(Vol-II) dated 23rd July, 2012.
Brand Name + Dosage Form + Strength Winrose Injection 100mg/5ml
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
Approval status of product in Reference VENOFER iron 100mg/5mL (as iron(III) hydroxide
Regulatory Authorities. sucrose complex) injection ampoule. TGA approved
Remarks of the Evaluator  Revise the label claim and salt from in line with
the reference product along with submission of
applicable fee.
 The firm submitted list of 03 products registered
Decision of 295th meeting: Deferred for DML status of M/s Alen.
Submission by the firm: The firm has submitted receiving of submission of application for Renewal
of DML on 18th Sep, 2019. Renewal of DML is due from 16/09/2019.
Decision: Deferred for confirmation of DML status of M/s Alen Pharmaceuticals pvt ltd,
Risalpur.
Brand Name + Dosage Form + Strength Zolid 600mg/300ml Infusion
Linezolid…600mg
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
Approval status of product in Reference ZYVOX linezolid 600mg/300mL injection infusion bag.
Regulatory Authorities. TGA approved

Remarks of the Evaluator  The firm submitted list of 03 products registered
th
D Decision of 295 meeting: Deferred for DML status of M/s Alen.
Risalpur.
Brand Name + Dosage Form + Strength Locrim 400mg Infusion
PKR. 50,000/-; 07.01.2019
Type of Form Form 5
Regulatory Authorities. hydrochloride) intravenous infusion solution bottle. TGA
approved
Remarks of the Evaluator  The firm submitted list of 03 products registered
Decision of 295th meeting: Deferred for DML status of M/s Alen.
Risalpur.
1956. Name and address of manufacturer / Applicant: M/s Saffron Pharmaceuticals (Pvt) Ltd. 19
Applicant Km Sheikhupura Road, Faislabad
Manufactured By: M/s Nabiqasim Industries Pvt Ltd.
Contract manufacturing 17/24, Korangi Industrial Area, Karachi, Pakistan.
Brand Name +Dosage Form + Strength Esofil 40mg IV Injection
(Lyophilized Powder for Solution)
Dated 16-11-2018

Type of Form Form 5
Approval Status of Product in Reference Nexium IV 40mg/vial injection by M/s
Regulatory Authorities ASTRAZENECA PHARMS (USFDA approved)
GMP Status M/s Nabi Qasim was last inspected on 03.10.2018,
.wherein the panel recommended the grant of GMP
certificate.
M/s Saffron Pharma, Last GMP inspection conducted on
08-10-2019, Good level of GMP.
Remarks of the Evaluator. The firm has applied for In-House specifications and the
product is not present in available pharmacopoeia (USP,
BP, IP, JP).
The applicant has submitted that they are not having any
manufacturing on contract basis from any firm. Currently
the firm have 08 sections.
Decision of 293rd meeting: Deferred for confirmation of manufacturing method (powder filling or
The applied product would be manufactured by way of Lyophilization at approved facility of M/s Nabi
Qasim Industries (pvt) ltd.. Section approval letter no. F.2-20/85
Lic(Vol-III)(M-227th) dated 20th June, 2011 for Lyophilized vials (General) is provided.
1957. Name and address of manufacturer / Applicant: M/s Saffron Pharmaceuticals (Pvt) Ltd. 19
Applicant Km Sheikhupura Road, Faislabad.
Manufactured By: M/s Nabiqasim Industries Pvt Ltd.
Contract manufacturing 17/24, Korangi Industrial Area, Karachi, Pakistan.
Brand Name +Dosage Form + Strength Noctis 40mg IV Injection
(Lyophilized powder for solution)
Omeprazole as Sodium………40mg
Form 5
Pack Size & Demanded Price 1’s, Price as per SRO
Approval Status of Product in Reference Omeprazole 40mg Powder for Solution for Infusion by
Regulatory Authorities M/s Sandoz Limited, MHRA Approved.
GMP Status M/s Nabi Qasim was last inspected on 03.10.2018,
.wherein the panel recommended the grant of GMP
certificate.
M/s Saffron Pharma, Last GMP inspection conducted on
08-10-2019, Good level of GMP.
BP, IP, JP).
The applicant has submitted that they are not having any
manufacturing on contract basis from any firm. Currently
the firm have 08 sections.

The applied product would be manufactured by way of Lyophilization at approved facility of M/s Nabi
Qasim Industries (pvt) ltd.. Section approval letter no. F.2-20/85
Lic (Vol-III)(M-227th) dated 20th June, 2011 for Lyophilized vials (General) is provided.
1958. Name and address of manufacturer / M/s Albro Pharmaceuticals,340/S Quaid-e-Azam
Applicant industrial estate, Kot Lakhpat Lahore applied for
contract manufacturing by M/s Bio Labs (Pvt) Ltd,
Islamabad
Brand Name +Dosage Form + Strength Alb-Penta injection IV
Diary No. Date of R& I & fee Dy. NO 633, 20-3-15, 50,000/-
Pantoprazole lyophilized…….40mg
Type of Form Form 5
Pack size & Demanded Price 1’s As per DRAP policy

Approval status of product in Reference Protonix by Wyeth (USFDA)
Me-too status Neege by Sami pharma
GMP status Last inspection conducted on 29.08.2017 for additional
section
Remarks of the Evaluator.  This plant possesses 3 sections (tablet, Capsule,
Oral liquid)
The firm has got registration of 16 products, on contract
manufacturing as per information provided by the
applicant
Decision of previous meeting of Registration Board deferred the case for clarification of
Registration Board number of products which are being manufactured on
contract manufacturing since the firm has got
registration of 16 products on contract manufacturing.
(M-277)
Evaluation by PEC Firm has 3 approved sections and already got
registration of 16 products, but after 277th meeting the
firm has submitted a letter for de registration of 8
already registered products on contract manufacturing
by Shrooq pharma and synchro pharma. The
Registration Board in its 291st meeting acceded the
request of the firm and decided to cancel the registration
of those 8 products.
Now the firm has submitted request against 6 deferred
cases.
Islamabad
Brand Name +Dosage Form + Strength Albepra injection

Omeprazole sodium equivalent to omeprazole….40mg
Type of Form Form 5

As per DRAP policy
Approval status of product in Reference Omeprazole IV of Sandoz (TGA)
Me-too status Loprot of Nabiqasim
section
Remarks of the Evaluator.  This plant possesses 3 sections (tablet, Capsule,
Oral liquid)
The firm has got registration of 16 products, on contract

manufacturing as per information provided by the
applicant
Decision of previous meeting of Registration Board deferred the case for clarification of
Registration Board number of products which are being manufactured on
contract manufacturing since the firm has got
(M-277)
request of the firm and decided to cancel the registration
of those 8 products.
cases.
Islamabad
Brand Name +Dosage Form + Strength Alb-EZO injection
Esomeprazole (as Sodium)…………..40mg
Type of Form Form-5
Finished Product Specification As per innovator

As Per SRO
Approval status of product in Reference Esomeprazole of Consilient pharma (MHRA)
Me-too status Brince of ACE
section
Remarks of the Evaluator.  This plant possesses 3 sections (tablet,
Capsule, Oral liquid)
The firm has got registration of 16 products, on

contract manufacturing as per information provided by
the applicant
Decision of previous meeting of Registration Board deferred the case for clarification
Registration Board of number of products which are being manufactured
on contract manufacturing since the firm has got
(M-277)
request of the firm and decided to cancel the
registration of those 8 products.
cases.
1961. Name and address of M/s Jaens Pharmaceutical Industries Pvt Limited.
manufacturer / Applicant 28-km Lahore-Sheikhupura Road, Sheikhupura
Brand Name +Dosage Form + Clida Gel 1%
Strength
Clindamycin Phospate eq to Clindamycin…1% 10mg
Pharmacological Group Antiinfectives for treatment of acne
Type of Form Form 5
Approval Status of Product in RESIDERM 1%w/w GEL by M/s Crawford Healthcare
Reference Regulatory Limited (MHRA Approved)
Authorities
Me-too Status Clindacin Gel 1%w/w by M/s Sante (Reg#067485)
GMP Status Same as stated above
Remarks of the Evaluator. Relevant section is not confirmed.
Decision of 295th meeting: Deferred for confirmation of approval of relevant/required manufacturing
facility.
Submission by the firm: The firm has submitted letter No.F.1-8/2001-Lic dated 8th May, 2018 issued
by Secretary, Central Licensing Board whereby the firm has granted Topical Preparation Section.
Decision: Approved.

Brand Name +Dosage Form + Sisul Cream, 1%
Strength
Silver Sulfadiazine…1% (w/w)
Type of Form Form 5
Approval Status of Product in Silvadene Cream 1% of USFDA approved
Reference Regulatory
Authorities
Me-too Status Quench 1% Cream by Ferozsons (Reg. No. 013090)
Remarks of the Evaluator. Relevant section is not confirmed.
Decision of 295th meeting: Deferred for confirmation of approval of relevant/required manufacturing
facility.
Submission by the firm: The firm has submitted letter No.F.1-8/2001-Lic dated 8th May, 2018 issued
by Secretary, Central Licensing Board whereby the firm has granted Topical Preparation Section.
Decision: Approved.
Brand Name +Dosage Form + Jusidic Eye Drops
Strength
Fusidic acid…1%
Pharmacological Group Anti-biotic
Type of Form Form 5
Approval Status of Product in Fucithalmic 1%w/w viscous eye drops, MHRA Approved
Authorities
Me-too Status Fusitek Eye Drops 1% by M/s Invotek Pharma, Reg. No. 26957
Ear/Eye Drops (General/Steroidal) section approved.
Remarks of the Evaluator. The firm has revised the formulation from 1% w/v to 1% w/w
without submission of fee.
Decision of 293rd meeting: Deferred for submission of applicable fee for revision of formulation.
Submission by the firm: The firm has submitted the fee Rs. 5,000/- vide challan number 1932506
dated 12/08/2020.
Decision: Approved.
1964. Name and address of manufacturer Applicant: M/s Seraph Pharmaceuticals pvt Ltd
/ Applicant Plot # 210, Industrial Triangle, Kahuta Road, Islamabad
Manufactured By: M/s Rotex Pharma Pvt Ltd.
Plot No. 206 & 207. Industrial Triangle, Kahuta Road,
Islamabad
Brand Name +Dosage Form + Hisone 250mg Injection IV/IM
Strength
Hydrocortisone sodium Succinate eq to
Hydrocortisone…250mg
Type of Form Form 5
Approval Status of Product in Solu-Cortef Act-O-Vial (100mg,250mg,500mg) powder for
Reference Regulatory Authorities injection by M/s Pfizer, MHRA Approved.
Me-too Status Cortizone 250mg Injection by M/s Vision Pharmaceuticals,
Reg. No. 81899
Remarks of the Evaluator. Number of products already being manufactured: 00
Number of approved sections: 07
Decision of 295th meeting: Deferred for confirmation of section in M/s Rotex Pharma Pvt Ltd .
Submission by the firm: The applicant has submitted Sterile Dry Powder Vial (Steroid) Section
approval letter No. F.1-53/2003-Lic(Vol-I) dated 4th Dec, 2018 issued by Secretary Licensing Board.
Decision: Aprproved.
1965. Name and address of Applicant M/s Excel Healthcare Laboratories Pvt Ltd.
House. D#122, Block 4 Federal B Area Karachi, Pakistan.
Name and address of M/s Pharma vision San. Ve Tic. A.S. Davutpasa Cad. No: 145
manufacturer Topkapi/Istanbul- Turkey
Marketing authorization holder M/s WORLD MEDICINE ILAC SAN. VE TIC. A.S. Gunesli,
Bagcilar/ Istanbul, Turkey
Exporting country Turkey
Diary No. & Date of R& I Dy. No 35530 Dated 25-10-2018
Brand Name +Dosage Form + Gembag
Strength 100mg/2ml Solution for IM Injection
Iron III hydroxide polymaltose complex….333.33mg
(Eq. to 100mg elemental iron)
Finished Product Specification Firm claim In-House specification
Pharmacological Group Parenteral iron preparation
Pack size & Demanded Price 2ml glass ampoule & As per SRO
International availability FERRUM H iron 100mg/2mL (as polymaltose) injection
ampoule (TGA Australia)
Me-too status Reg No. 041029by M/s Schazo Pharma Lab.
Stability studies Firm has submitted long term (24 months) at 30+2oC, 65+5%RH
& accelerated (06 months) stability data at 40+ 2oC, 75+ 5% RH
for three batches.
Detail of certificates attached  Original Legalized CoPP (Certificate#. 2018/1000) issued on
07-03-2018 by Republic of Turkey Ministry of Health Turkish
Medicines and Medical Devices Agency declaring the free sale
of applied product and GMP compliant status of the
manufacturer i.e., M/s Pharmavision San. Ve Tic. A.S.
Davutpasa Cad. No: 145 Topkapi/Istanbul- Turkey. This
certificate is valid until 17-03-2020.
 Original product specific Sole agency agreement dated 23rd
March 2018 of importer M/s Excel Healthcare Laboratories Pvt
Ltd with Product License Holder M/s WORLD MEDICINE
ILAC SAN. VE TIC. A.S. Gunesli, Bagcilar/ Istanbul, Turkey.
Decision of 293rd meeting: Deferred for submission of differential fee i.e. 50,000/- since the applied
formulation is already registered by DRAP.
Evaluation by PEC: The firm has submitted differential fee Rs. 50,000/- vide challan number
2001025 dated 13/08/2020.

Decision: Approved with Innovator’s specifications as per Policy for inspection of
Manufacturer abroad. Firm will provide valid CoPP for further processing of case.
1966. Name and address of manufacturer / M/s Hiranis pharmaceuticals (Pvt.) Ltd. plot No.E-
Applicant 145 to E-149, North Western Industrial Zone, port
Qasim, Karachi
Brand Name +Dosage Form + Strength Laderfex-D Tablet 60/12 0
Fexofendine HCl………….60mg
Pseudoephedrine HCl……..120mg
(Extended Release)
Diary No. Date of R& I & fee Dy. No 10954 Dated 05-03-2019, Rs. 20,000/-
Pharmacological Group Antihistamine/Sympathomimetic
Type of Form Form-5
Finished product Specification USP Specification
Pack size & Demanded Price As per PRC
Approval status of product in Reference ALLEGRA-D Tab of Sanofi Aventis, USFDA
Me-too status Fenadrin D Tablet of Noa Hemis (Reg#042352)
GMP status As recorded for above application
Decision of 289th meeting: Deferred for evidence of approval of requisite manufacturing
facility/section from licensing division
Evaluation by PEC: The firm has submitted letter No. F.1-33/2009-Lic dated 07/02/2014 whereby
the firm has been granted for Tablet General Section.
As the applied product is bilayer and it is evident from the provided inspection report dated
13/02/2019 conducted for Renewal of DML that the firm has Double Layer Tablet Compression
Machine in “Psychotropic Tablet Section”. While Inspection conducted for grant of DML dated
23/09/2013 shows that the Bilayer tablet machine is available in Tablet (General) Section as well.
Decision: Approved.
Qasim, Karachi
Brand Name +Dosage Form + Strength Hirafen-Plus Tablet 200mg/30mg
Composition Each film coated tablet contains:-
Ibuprofen……………………200mg
Pseudoephedrine HCl………..30mg
Pharmacological Group NSAID/Sympathomimetic
Type of Form Form-5
Finished product Specification Manufacturer Specification
Approval status of product in Reference Advil Cold and Sinus of Pfizer, USFDA
Me-too status Rovinac Tablets of Rock Pharma (Reg# 064206)
facility/section from licensing division.
Decision: Approved with innovator’s sepcifications.
Qasim, Karachi

Brand Name +Dosage Form + Strength Slorit-D Tablet 2.5/120
Desloratadine………………2.5mg
Pseudoephedrine Sulfate…..120mg
(Extended Release)
Pharmacological Group Antihistamine/Sympathomimetic Amine
Type of Form Form-5
Approval status of product in Reference CLARINEX-D of MSD, USFDA
Me-too status DESRHIN Tab of Atco (Reg#067246)
Decision: Approved.
Qasim, Karachi
Brand Name +Dosage Form + Strength Slorit-D Tablet 5/240
Desloratadine………………5mg
Pseudoephedrine Sulfate…..240mg
(Extended Release)
Pharmacological Group Antihistamine/Sympathomimetic Amine
Type of Form Form-5
Approval status of product in Reference CLARINEX-D of MSD, USFDA
Me-too status DESRHIN Tab of Atco (Reg#067247)
Decision: Approved.
1970. Name and address of manufacturer / M/s Fynk Pharmaceuticals, 19 Km G.T. road, Kalashah
Applicant Kaku, Lahore.
Brand Name +Dosage Form + Strength COLIMETH Dry powder for Injection
Diary No. Date of R& I & fee Dy.No. 35528 dated 25/10/2018 PKR 20,000/-
Composition Each vial contains;
Colistimethate Sodium……….1MIU (eq. to 80mg)
Type of Form Form 5
Pack Size & Demanded Price 1’s, 10’s
Approval Status of Product in Reference Promixin, 1 million International Units (IU), Powder for Solution
Regulatory Authorities for Infusion, which is approximately equivalent to 80 mg of
colistimethate sodium by M/s Zambon S.p.A., MHRA Approved.
Me-too Status Colistat powder for Injection 1MIU by M/s Medisure
Lab (Reg#076160)
GMP Status Last inspection report dated 20/09/2017 concludes the
overall condition of the firm as satisfactory.
Submission by the firm: The firm has submitted that lyophilized raw material will be imported and
filled in General Powder Filling section. The firm has been granted Dry Powder Injection (General)
Section vide section approval letter No. F.1-63/84-Lic (Vol-III-A) dated 3rd October, 2019.
Decision: Approved.
1971. Name and address of M/s Medera Pharmaceuticals Pvt Ltd.
manufacturer / Applicant Plot #2, Street #4, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Q-Med XR-300 Tablets
Strength
Type of Form Form 5
Approval Status of Product in Alaquet XL (50mg, 150mg, 200mg, 300mg, 400mg) film coated
Reference Regulatory prolonged-release tablets by M/s Generics [UK] Limited t/a Myla,
Authorities MHRA Approved.
Remarks of the Evaluator. evidence of approval of applied formulation already approved by
Decision of 295th meeting: Deferred for evidence of approval of applied formulation already approved
by DRAP (generic / me-too status) along with registration number, brand name and name of firm.
The firm has provided following me too reference which has been verified from the available data
base;
Qusel XR 300mg Tablet of M/s Hilton Pharma , Reg No. 76087.
Decision: Approved.
1972. Name and address of M/s Medera Pharmaceuticals Pvt Ltd.
manufacturer / Applicant Plot #2, Street #4, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Q-Med XR 150 Tablets
Strength
Type of Form Form 5

Approval Status of Product in Alaquet XL (50mg, 150mg, 200mg, 300mg, 400mg) film coated
Reference prolonged-release tablets by M/s Generics [UK] Limited t/a Myla,
Remarks of the Evaluator. evidence of approval of applied formulation already approved by
Decision of 295th meeting: Deferred for evidence of approval of applied formulation already approved
by DRAP (generic / me-too status) along with registration number, brand name and name of firm.
The firm has provided following me too reference which has been verified from the available data
base;
Qusel XR 150mg Tablet of M/s Hilton Pharma , Reg No. 067501.
Decision: Approved.
1973. Name and address of manufacturer / M/s Avensis Pharmaceuticals F-24/1, Eastern
Applicant Industrial Zone, Bin Qasim Karachi Pakistan
Brand Name +Dosage Form + Strength Ceftax 250mg Injection
Cefotaxime (as cefotaxime sodium)……. 250mg
Diary No. Date of R& I & fee Dy. No. 10774 dated 05/03/2019 R. 20,000/- dated
05/03/2019
Type of Form Form 5
Finished Product Specification B.P
Pack size & Demanded Price 1’s, as per SRO
Me-too status Cefon injection 250mg (vial) of M/s Tabros Pharma
GMP status CLB in its 267th meeting approved the new Section for
Capsule general on dated 31st December 2018.
Decision pf 291st meeting:
Evidence of approval of applied formulation in reference regulatory authorities/agencies which
Evaluation by PEC:
The applied product is approved by CIMA Spain and the reference provided by the firm has been
verified and given in the following;
Caefotaxima Normon 250mg powder and solvent for injectable IV EFG (Status: Marketed).
Each vial contains:
Cefotaxime as sodium…… 250mg
The website was accessed on 29/06/2020.
https://cima.aemps.es/cima/publico/lista.html
Decision: Approved.
1974. Name & Address of Manufacturer M/S Legacy Pharmaceuticals (Pvt) Ltd111-A,
Applicant Industrial Estate Hayatabad Peshawar - 25000 K. P. K
Pakistan
Brand Name + Dosage Form + Strength CLOBAM Tablet 10mg
Clobazam……..10mg
Diary No. Date of R & I & Fee Dy No.12236 dated 06-03-2019 ; Rs.20,000
06/03/2019
Type of Form Form 5
Finished Product Specification B.P Specs
Pack Size & Demanded Price 3×10’s Price as per SRO
Approval Status of Product in Reference Onfi tablet (10mg, 20mg) by M/s Lundbecl Pharms
Regulatory Authorities LLC, USFDA Approved
Me - too Status Frisium tablet 10mg Reg No 2692
G. M. P. Status Inspection report dated 22/02/2019 confirms
satisfactory level of cGMP compliance.
Remarks of Evaluator The proposed formulation contains overage with no
scientific justification.
Decision of 293rd meeting: Deferred for scientific justification of overage present in the applied
formulation.
Evluation by PEC:
The firm has submitted revised formulation along with the master formula omitting the overage.
Decision: Deferred for confirmation of requisite manufacturing facility / Section for
manufacturing of the applied product.
Pakistan
Brand Name + Dosage Form + Strength DINOP – E2 Tablet 3mg
Dinoprostone…….. 3mg
Diary No. Date of R & I & Fee Dy. No.6511 dated 14-02-2019 ; Rs.20,000
14/02/2019
Pharmacological Group Prostaglandin Analog
Type of Form Form 5
Approval Status of Product in Reference Prostin E2 vaginal tablet by M/s Pfizer MHRA
Me - too Status Prostin E-2 by Pfizer vaginal tablets (Reg. No.
009821)
Remarks of Evaluator The firm has applied for oral tablet while the product
approved in reference authority is Vaginal Tablet.
Decision of 293rd meeting: Deferred for following:
with registration number, brand name and name of firm
were declared/approved by the Registration Board
Evaluation by PEC:
The firm has stated that it was a typographical error and Oral Tablet was written instead of Vaginal
Tablet. The evidence of approval in reference authority and me-too status have already been verified
as Vaginal tablet. Following is the correct label claim submitted by the firm. The firm has no
tsubmitted any fee.
Each vaginal tablet contains:
Dinoprostone…….. 3mg
Pakistan
Brand Name + Dosage Form + Strength TENIL Tablet 6mg
Bromazepam……6mg
Diary No. Date of R & I & Fee Dy. No.6506 dated 14-02-2019 ; Rs.20,000
14/02/2019
Type of Form Form 5

Approval Status of Product in Reference Apo-bromazepam tablet (1.5mg, 3mg, 6mg) by M/s
Regulatory Authorities Apotex Inc. Health Canada Approved
Me - too Status Yazd 6mg Tablet By M/s. Wilshire Laboratories (Pvt)
Ltd; Reg No. 65693
Decision of 293rd meeting: Deferred for the following scientific justification of overage present in
the applied formulation.
Evaluation by PEC:
The firm has submitted revised formulation without overage.
Pakistan
Brand Name + Dosage Form + Strength XINIL Tablet 0.25mg
Alprazolam……. 0.25mg
14/02/2019
Type of Form Form 5
Approval Status of Product in Reference
Xanax 0.25mg by M/s Pfizer, MHRA Approved
Me - too Status Lydia 0.25mg Tablets by M/s. Wilshire Laboratories
(Pvt) Ltd; Reg No. 65697
Decision of 293rd meeting: Deferred for the following scientific justification of overage present in the
Evaluation by PEC:
The firm has submitted revised formulation of the product omitting overage.
Pakistan
Brand Name + Dosage Form + Strength XINIL Tablet 0.5mg
Alprazolam……. 0.5mg
14/02/2019
Type of Form Form 5
Approval Status of Product in Reference Xanax 0.50mg by M/s Pfizer, MHRA Approved

Evaluation by PEC:
Pakistan
Brand Name + Dosage Form + Strength XINIL Tablet 1 mg
Alprazolam……. 1 mg
14/02/2019
Type of Form Form 5
Approval Status of Product in Reference Xanax 1.0mg by M/s Pharmacia and Upjohns,
Evaluation by PEC:
1980. Name and address of manufacturer / M/s Ciba Pharmaceutical private limitd, plot no.
Applicant A-371, Nooriabad site industrial Area, Super highway
Karachi.
Brand Name +Dosage Form + Strength VOXY 100mg capsule
Doxycycline as hyclate…….100mg
Pharmacological Group tetracycline
Type of Form Form 5
Pack Size & Demanded Price 5’s×2, 5’s×6, 5’s×10, 5’s×20, price as per SRO
Approval Status of Product in Reference Doxycycline 100mg Capsules by M/s Kent Pharmaceuticals
Regulatory Authorities Ltd, MHRA Approved.
Me-too Status Medox Capsule 100mg by M/s Maxitech, Reg. No.
84781
GMP Status GMP certificate has been issued on 20/08/2019 based
on inspection conducted on 07/08/2019.
Remarks of the Evaluator. The firm has revised the formulation from
doxycycline monohydrate to Doxycycline as
hyclate as per the composition of the reference
product without submission of Fee.
Decision of 293rd meeting: Deferred for submission of fee (Rs. 20,000/-) for revising the formulation
from doxycycline monohydrate to Doxycycline as hyclate as per the composition of the reference
product.
Evaluation by PEC: The firm has submitted Rs. 20,000/- vide challan no. 0768949 dated 11/03/2020
for revision of formulation as per the reference product. The following is the correct label claim of
the applied product.
Each capsule contains:
Doxycycline as hyclate…….100mg
Decision: Approved.
1981. Name and address of manufacturer / M/s Saffron Pharmaceuticals (Pvt) Ltd.
Applicant 19 Km Sheikhupura Road, Faislabad
Brand Name +Dosage Form + Strength Midaz 7.5mg Tablet
Midazolam as Maleate……7.5mg
Pharmacological Group Sedative/Hypnotic
Type of Form Form 5
Pack Size & Demanded Price 10’s price Rs. 200/-, 20’s price Rs. 250/-
Approval Status of Product in Reference Dormicum (7.5mg & 15mg) film coated Tablets by
Regulatory Authorities M/s CHEPLAPHARM Arzneimittel GmbH,
Netherlands Approved.
Me-too Status Dorminic Tablets 7.5mg tablet by M/s Dosaco
Laboratories, Reg No. 24295
GMP Status The firm was last inspected on 03.10.2018, .wherein
the panel recommended the grant of GMP certificate
Remarks of the Evaluator. The firm has applied for In-House specifications and
the product is not present in available pharmacopoeia
(USP, BP, IP, JP).
Alternate brand name:
Mezolam
Saf-mif
 The firm has revised the formulation of applied
product from Midazolam as Hydrochloride to
Midazolam as Maleate and submitted fee Rs.
5000/- vide challan number 0828860 dated
12/12/2019.
rd
Decision of 293 meeting: Deferred for submission of differential fee of Rs. 15000/- for revision
of formulation.
Evaluation by PEC: The firm has submitted remaining fee of Rs. 15,000/- vide challan number
0828873 dated 17/02/2020 for revision of formulation as per the reference product. Following is
the correct label claim of the product.
Each Film coated Tablet Contains:
Midazolam as Maleate……7.5mg
1982. Name and address of manufacturer / M/s Biogen Pharma, 8-KM chakbeli road, Rawat,
Applicant Rawalpindi.
Brand Name +Dosage Form + Strength TARADOL tablet 37.5mg/325mg
Composition Each Film Coated tablet contains:
Tramadol hydrochloride…….37.5mg
Paracetamol………………….325mg
Pharmacological Group Antipyretic/Analgesic
Type of Form Form 5
Pack Size & Demanded Price 2×10’s, Price as recommended by PRC
Approval Status of Product in Reference Ultraset film coated tablet by M/s Janssen Pharms,
Me-too Status Tramal Plus tablet by M/s Searle Company
limited, Reg No.77129
not found working as required under the law rule.
Decision of 293rd meeting: Registration Board referred the case to QA & LT Division to conduct
GMP inspection of firm on priority.
Evaluation by PEC: The firm has submitted last inspection report dated 25/11/2019 & 12/12/2019,
the panel recommended renewal of DML. (letter NO. F.3-2/2007-FID-I(ISB) dated 19/12/2019).
Decision: Approved.
1983. Name and address of manufacturer / M/s Biogen Pharma.
Applicant 8-Km, Chakbeli Road, Rawat, Rawalpindi, Pakistan
Diary No. Date of R& I & fee Dy.No 35106 dated 23-10-2018 Rs.20,000/- Dated
22-10-2018
Brand Name +Dosage Form + Strength Velanef 800mg Tablets
Sevelamer HCL…800mg
Pharmacological Group Phosphate Binder
Type of Form Form-5
Approval status of product in Reference Renagel 800mg Tablet by M/s Genzyme
Regulatory Authorities. Corporation,
(USFDA approved)
Me-too status Renavel 800mg Tablet by M/s AllianzeMed
Pharmaceuticals (Reg No:075510)
GMP status 26-10-2018. The firm is not found working as
required under the law/rule
Decision of 293rd meeting: Deferred for updated GMP status of the firm from QA&LT Division.
Evaluation by PEC: The firm has submitted last inspection report dated 25/11/2019 & 12/12/2019,
the panel recommended renewal of DML. (letter NO. F.3-2/2007-FID-I(ISB) dated 19/12/2019).
1984. Duplication
1985. Name and address of manufacturer / AJM Pharma, Plot No. 44, sector No. 27 korangi
Applicant Inustrial Area Karachi
Brand Name +Dosage Form + Strength Asclop tablet 75mg/75mg
Diary No. Date of R& I & fee Dy. No. 1315 dated 03/05/2017 Re. 20,000/-
Clopidogrel as bisulfate…. 75mg
Acetyl salicylic acid………75mg
Pharmacological Group ADP induced platelet aggregation inhibitor
Type of Form Form 5
Pack Size & Demanded Price Rs. 220/- per pack of 10’s
Approval Status of Product in Reference CoPlavix Tablet Clopidogrel (as hydrogen sulfate) and
Regulatory Authorities aspirin by M/s sanofi-aventis, (TGA Approved)
Me-too Status Clodril Plus Tablet M/s Macter International, Reg. No.
55982
GMP Status Same as for the previous case
BP, IP, JP).

Alternate brand names:
Asplat
Clopiclot
Decision of 293rd meeting: Deferred for clarification of the dosage of the Innovator product,
whether bilayer tablet or otherwise.
Evaluation by PEC: The firm has submitted the applied product is not bilayered while it is immediate
release film coated tablet. The statement has not been verified from EMA assessment report. The
product approved in EMA is bilayered.
Decision: Deferred for submission of evidence of approval of applied formulation as “film
coated tablets” in reference regulatory authorities/agencies which were adopted by the
Registration Board in its 275th meeting or else the formulation may be revised in accordance
with reference product along with submission of requisite fee along with the proof of
availability of bilayer tabletting machine.
1986. Name and address of manufacturer / M/s CCL Pharmaceuticals Pvt. Ltd. 62 industrial estate,
Applicant kot Lakhpat, Lahore.
Brand Name +Dosage Form + Strength Ezestatin Tablet 1.2
Diary No. Date of R& I & fee Each film coated tablet contains:
Ezetimibe……..10mg
Atrovastatin….20mg
Composition Dy. No. 7989 Dated 22-02-2019, Rs. 20,000/- dated
22-02-2019
Pharmacological Group Cholesterol absorption inhibitors
Finished Product Specification Innovator’s specification
Approval Status of Product in Reference Ezetimibe and Atrovastatin calcium (USFDA)
Me-too Status
GMP Status DML of M/s CCL pharma No. 000052 by way of
formulation dated 21-07-2015
GMP inspection dated 20th & 24th April 2018 and
the panel recommendations “the firm was found
to be satisfactory level of GMP compliance”.
Remarks of the Evaluator. The applied product was already registered in the name
of the applicant with reg. no. 062853 dated 28th May
2010, but they did not apply for renewal. Now firm
apply for registration with full fee.
st
Decision of 291 meeting: Deferred for confirmation of status of previous registration from RRR
section.
Current Status: RRR section was asked for current status of renewal of the applied products vide
letter no. F.9-1/2019-PEC dated 2nd march, 2020. The RRR section has stated that “as per available
record, the renewal submission of the products overleaf is not available”.
The case is hereby place before the Board.
1987. Name and address of manufacturer / M/s CCL Pharmaceuticals Pvt. Ltd. 62 industrial estate,
Applicant kot Lakhpat, Lahore.
Brand Name +Dosage Form + Strength Ezestatin Tablet 1.4
Diary No. Date of R& I & fee Each film coated tablet contains:
Ezetimibe……..10mg
Atrovastatin….40mg
Composition Dy. No. 7990 Dated 22-02-2019, Rs. 20,000/- dated
22-02-2019
Pharmacological Group Cholesterol absorption inhibitors
Finished Product Specification Innovator’s specification
Approval Status of Product in Reference Ezetimibe and Atrovastatin calcium (USFDA)
Me-too Status
GMP Status DML of M/s CCL pharma No. 000052 by way of
formulation dated 21-07-2015
GMP inspection dated 20th & 24th April 2018 and
the panel recommendations “the firm was found
to be satisfactory level of GMP compliance”.
Remarks of the Evaluator. The applied product was already registered in the name
of the applicant with reg. no. 062853 dated 28th May
2010, but they did not apply for renewal. Now firm
apply for registration with full fee.
Decision of 291st meeting: Deferred for confirmation of status of previous registration from RRR
section.
Current Status: RRR section was asked for current status of renewal of the applied products vide
letter no. F.9-1/2019-PEC dated 2nd march, 2020. The RRR section has stated that “as per available
record, the renewal submission of the products overleaf is not available”.
The case is hereby place before the Board.
1988. Name and address of M/s Pharmix Laboratories (Pvt.) Ltd., 21-km, Ferozepur Road,
manufacturer/Applicant Lahore
Brand Name +Dosage Form + Prozol Capsule 30mg
Strength
Enteric coated pellets eq. to Lansoprazole….30mg
(Source of Pellet M/s Murli Krishna Pharma Pvt. Ltd. D-98,
Ranjangaon, Taluka-Shirur, Pune 412209 Maharashtra state,
India)
Diary No. Date of R& I & fee Dy. No. 32736 dated 02-10-2018, Rs. 15,000/- dated 15-10-
2009, and Rs. 85000/- dated 22-09-2016
Pharmacological Group PPI’s
Type of Form Form-5
Pack size & Demanded Price Rs.425/Pack of 14’s
Reference Regulatory Authorities Lansoprazole 30 mg gastro-resistant capsules (UK)
status
Me-too status Arcozol Capsules 30mg of M/s Pakistan Pharmaceutical
Products (Pvt) Ltd, Karachi
GMP status GMP inspection by inspectors dated 31-05-2018 & 01-06-2018
shows the acceptable level of compliance of GMP.
Remarks of the Evaluator Provided stability studies of Lansoprazole pellets 8.5%w/w at
30±20C, 65%±5% RH of 12 months and at 25±20C, 60%±5%
RH of 48 months
Decision of 293rd meeting: Deferred for submission of stability data of pellets through shelf life as
per Zone IVA.
Submission by the firm: The firm has submitted long term stability study data of 03 batches for 36
months period according to the conditions of zone IV-A. However, accelerated stability data is not
submitted.
Decision: Deferred for submission of Accelerated Stability data of 03 batches of pellets.
1989. Name and address of manufacturer / M/s AAA Healthpharmaceuticals Laboratories, Plot # 9A,
Applicant St#N-5, National Industrial Zone, (RCCI) Rawat,
Islamabad
Brand Name +Dosage Form + Strength Soulpride 50mg Tablet
Diary No. Date of R& I & fee Diary No, Date of R & I & fee Dy. No. 22438 dated 27-
06-2018 Rs20,000/-Dated 27-06-18
Levosulpride…………..50mg

Type of Form Form 5
Finished Product Specification Inovator’s specification
Pack Size & Demanded Price 20’s & As per SRO
Approval Status of Product in
Me-too Status Sulprex Tablets 50mg of M/s Global Pharmaceuticals
GMP Status DML by way of formulation No. 000871
dated 13-09-2017.
GMP Status Could not be confirmed
Decision of 292nd meeting: 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: The applied product is approved by AIFA Italy.
LEVOPRAID 50 mg tablet by M/s TEOFARMA Srl - Via F.lli Cervi, AIFA Italy Approved.
Levosulpride…………..50mg
GMP status of the firm could not be confirmed.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
1990. Name and address of M/s Nabiqasim Industries Pvt. Ltd. 17/24, Korangi
manufacturer/Applicant Industrial Area, Karachi, Pakistan
Manufacturer:
M/s Surge Laboratories Pvt. Ltd., 10th Km, Faisalabad
Road Bikhi, District Sheikhupura Pakistan
Brand Name +Dosage Form + Strength TEMSUNATE 60mg Injection
Artesunate ……………60mg
Diary No. Date of R& I & fee Dy. No 28674 Dated 27-08-2018, Rs. 50,000/- dated 27-
08-2018
Type of Form Form-5
Finished product Specification Firm claim manufacturer specification’s
Pack size & Demanded Price 1’s & As per PRC
Approval status of product in Reference WHO recommended formulation
Me-too status Gen-M 60mg Injection of M/s Genix Pharma (Pvt) Ltd.
GMP status M/s Nabiqasim Industries Pvt. Ltd:
DML by way of formulation 12-07-2014 & GMP
inspection by inspectors dated 03-08-2017 shows the
acceptable level of compliance of GMP
M/s Surge Laboratories Pvt. Ltd:
cGMP inspection dated 05-05-2019 shows good level of
cGMP compliance of the firm.
Decision of 292nd meeting of Registration Board:
Deferred for evidence of approval of applied formulation in reference regulatory authorities /
agencies which were adopted by the Registration Board in its 275th meeting.
Now the firm has submitted the evidence of WHO recommended formulation which is access dated
06th December 2019
http://archives.who.int/eml/expcom/expcom15/applications/formulations/artesunate.pdf
Decision of 293rd meeting: Deferred for evidence of approval of requisite manufacturing
facility from licensing division.
Submission by the firm: The applicant has submitted that M/s Surge Laboratories was
granted Additional section of Dry Powder Injectable (General) vide letter No. F.1-18/95-
Lic(Vol-III) dated 7th July, 2020. The copy of letter is attached with the submission.
Case No. 2. Registration Applications for Local Manufacturing of (Veterinary) Drugs.
a. New Cases (Local manufacturing) Veterinary

1991. Name and address of manufacturer / M/s Biogen Pharma, 8-KM chakbeli road, Rawat,
Applicant Rawalpindi.
Brand Name +Dosage Form + Strength MAXIFLOR 30% Oral Liquid
Florfenicol..…………30% (w/v)
Type of Form Form 5
Pack Size & Demanded Price Plastic bottle of 100ml, 500ml, 1000ml, price
decontrolled
GMP Status Last inspection report dated 18/08/2017 concludes the
overall GMP compliance level as good.
Remarks of the Evaluator. Evidence of applied formulation/drug already
firm.
b. Deferred cases (local manufacturing) Veterinary
1992. Name and address of Applicant/ M/s Farm Aid Group Plot # 3/2, phase I & II, Hattar Industrial
Manufacturer Estate, Haripur
DML DML by way of formulation dated 25-10-2015.
Type of Form Form-5

Brand Name +Dosage Form + MOXY CS POWDER
Strength
Composition Each 1000gram contains:
Amoxicillin Trihydrate……150gm
Colistin sulphate…………25gm
Finished Product Specification Firm claim innovator’s specification
Pack size 10gm, 20gm, 30gm, 50gm, 100gm, 250gm, 500gm, 1kg,
5kg, 10kg, 15kg, 20kg, 25kg
Me-too status Moxicoli water soluble powder of m/s zumars pharma (pvt)
ltd. Karachi.
GMP status GMP inspection dated 03-10-2018
Conclusion:
During the inspection, some suggestions were given for
improvement and certain shortcomings were also identified.
The Firm’s management looked committed in rectifying the
shortcomings and assured to do so in the shortest possible
time. Therefore, keeping in view the environmental,
manufacturing and quality control facilities provided,
discussions made with the technical personnel, the
documentations presented and reviewed, the raw materials
consumed in manufacturing of the registered products and
commitment of the firm’s management in rectifying the
shortcomings, the firm M/s Farm Aid Group Haripur is
considered to be maintaining satisfactory level of the cGMP
and found to be fulfilling GMP requirements
Decision of 293rd meeting: Deferred for evidence of approval of requisite maujfacturing facility
(penicillin) from licensing division.
Submission by the firm: The firm has submitted approval letter No.F.3-9/91-Lic(Vol-I) dated 21st
June, 2017 for Dry Powder Section (Vet) section.
Decision: Deferred for confirmation of required manufacturing facility “Dry Powder penicillin
(Veterinary)” section.
Case No. 3: Registration Applications of Newly Granted DML or New Section (Veterinary)
a. New Section:
Vet New Section
M/s Medi-Excel Pharmaceutical, Plot No. 282, Industrial Triangle, Kahuta Road, Islamabad was granted
additional sections vide letter no. F.1-2/2001-Lic (Vol-I) dated 29/09/2019. The firm has applied for following
products against relevant sections as under.
GENERAL INJECTABLE SECTION (VET) NEW

One product/molecule was approved in 294th meeting of Registration Board in General Injectable Section
(Vet). Further 9 molecules and 29 products are remaining.
NO OF MOLECULES NO PRODUCTS
9 31
1993. Name and address of manufacturer / "M/s Mediexcel Pharmaceuticals Islamabad. Plot # 282
Applicant Industrial Triangle, Kahuta Road Humak, Islamabad 45700,
Pakistan"
Brand Name +Dosage Form + Strength Iverexcel 10 Injection
Composition "Each ml Injection contains:
Ivermectin………10 mg"
Diary No. Date of R& I & fee Dy. No 20823 dated 21-08-2020 Rs. 20,000/- 20-08-2020
Type of Form Form-5
Pack size & Demanded Price 50ml /Decontrolled
Me-too status (with strength and dosage Actimec Injection (10ml, 20ml, 50ml, 100ml) of M/s
form) Selmore Pharmaceuticals Pvt Ltd, (Reg.# 034595)
GMP status Firm has submitted copy of GMP certificate (Sr.No.0709) that
was issued on 08-10-2019 & Copy of renewed DML No.
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Type of Form Form-5
Pack size & Demanded Price 10 ml /Decontrolled
Me-too status (with strength and dosage Actimec Injection (10ml, 20ml, 50ml, 100ml) of M/s
form) Selmore Pharmaceuticals Pvt Ltd, (Reg.# 034595)

000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Type of Form Form-5
Me-too status (with strength and dosage Selmec Injection (10ml, 50ml, 100ml) of M/s Selmore
form) Pharmaceuticals Pvt Ltd, (Reg.# 071087)
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Type of Form Form-5
Me-too status (with strength and dosage Selmec Injection (10ml, 50ml, 100ml) of M/s Selmore
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Brand Name +Dosage Form + Strength Melowin 7.5 Injection
Composition "Each ml contains:
Meloxicam……….7.5mg"
Type of Form Form-5
Finished product Specifications Innovator’s Specification
Pack size & Demanded Price 100 ml/Decontrolled
Me-too status (with strength and dosage Camilox Injection (10ml, 20ml, 50ml, 100ml) of M/s Selmore
000519 on Dated: 02-11-2019.
Decision: Approved.

Pakistan"
Brand Name +Dosage Form + Strength Melowin 7.5 Injection
Meloxicam……….7.5mg"
Type of Form Form-5
Me-too status (with strength and dosage Camilox Injection (10ml, 20ml, 50ml, 100ml) of M/s Selmore
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Melowin 10 Injection
Meloxicam……….10mg"
Type of Form Form-5
Me-too status (with strength and dosage Meloxi-10 Injection (10ml, 20ml, 50ml, 100ml vial) of M/s
form) Selmore Pharmaceuticals Pvt Ltd, (Reg.# . 049643)
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5
Me-too status (with strength and dosage Meloxi-10 Injection (10ml, 20ml, 50ml, 100ml vial) of M/s
000519 on Dated: 02-11-2019.
Pakistan"

Type of Form Form-5
Me-too status (with strength and dosage Melocam-20 Injection (10ml, 20ml, 30ml, 50ml, 100ml vial)
form) of M/s Selmore Pharmaceuticals Pvt Ltd, (Reg.# . 057007)
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5
Me-too status (with strength and dosage Melocam-20 Injection (10ml, 20ml, 30ml, 50ml, 100ml vial)
form) of M/s Selmore Pharmaceuticals Pvt Ltd, (Reg.# . 057007)
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Flunixel 50 Injection
Flunixin Meglumine……..50mg"
Type of Form Form-5
Me-too status (with strength and dosage Loxin Injection (10ml, 20ml, 50ml vial) of M/s Selmore
form) Pharmaceuticals Pvt Ltd, (Reg.# . 035098)
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Brand Name +Dosage Form + Strength Flunixel 50 Injection
Flunixin Meglumine……..50mg"
Type of Form Form-5

Me-too status (with strength and dosage Loxin Injection (10ml, 20ml, 50ml vial) of M/s Selmore
000519 on Dated: 02-11-2019.
Decision: Approved.
Applicant Industrial Triangle, Kahuta Road, Humak, Islamabad 45700,
Pakistan"
Brand Name +Dosage Form + Strength Ketoexel 100 Injection
Ketoprofen………..100mg"
Type of Form Form-5
Me-too status (with strength and dosage Ketoject Injection (10ml, 20ml, 50ml, 100ml vial) of M/s
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5

000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Nitroxl 34 Injection
Nitroxynil……….340 mg"
Type of Form Form-5
Me-too status (with strength and dosage Troxy 34% Injection (10ml, 20ml, 50ml, 100ml vial) of M/s
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.

Pakistan"
Brand Name +Dosage Form + Strength MEKSOL 12 Injection
Ivermectin…………..20 mg
Clorsulon……………..100 mg "
Type of Form Form-5
Me-too status (with strength and dosage Actimec DS Injection 100ml vial of M/s Selmore
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.
Remarks of the Evaluator The filled volume of already registered product is different
from the applied product.
Decision: Deferred for evidence of applied formulation/drug in the applied filled volume already
approved by DRAP (generic / me-too status) alongwith registration number, brand name and
name of firm.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.

name of firm.
Pakistan"
Type of Form Form-5
Me-too status (with strength and dosage Actimec Plus Injection (10ml, 50ml, 100ml vial) of M/s
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.
Decision: Approved.
Pakistan"
Type of Form Form-5
000519 on Dated: 02-11-2019.

Decision: Approved.
Pakistan"
Brand Name +Dosage Form + Strength Mekvita Injection
Ivermectin………..10 mg
Vitamin A………..25000IU
Vitamin D………..3750IU
Vitamin E ………..25mg
Pharmacological Group Anthelmintic and Vitamin
Type of Form Form-5
Me-too status (with strength and dosage Actimec Forte Injection 50ml vial of M/s Selmore
000519 on Dated: 02-11-2019.
name of firm.
Pakistan"
Type of Form Form-5
Me-too status (with strength and dosage Actimec forte injection 50ml vial by M/s Selmore, Reg. No.
form) 102087
000519 on Dated: 02-11-2019.
Pakistan"
Type of Form Form-5
th
Me-too status (with strength and dosageActimec forte injection 50ml vial by M/s Selmore, Reg. No.
form) 102087
000519 on Dated: 02-11-2019.
name of firm.
Pakistan"
Brand Name +Dosage Form + Strength Buparxel Injection
Buparvaquone……. 50 mg"
Type of Form Form-5
Me-too status (with strength and dosage Parvon Injection (10ml, 20ml, 40ml and 100ml vial) of M/s
form) Selmore Pharmaceuticals Pvt Ltd, (Reg.# . . 034580)
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Buparxel Injection
Buparvaquone…….50 mg"
Type of Form Form-5
Me-too status (with strength and dosage Parvon Injection (10ml, 20ml, 40ml and 100ml vial) of M/s
form) Selmore Pharmaceuticals Pvt Ltd, (Reg.# . . 034580)
000519 on Dated: 02-11-2019.
Remarks of the Evaluator The applied filled volume of 50ml is not approved while other
filled volumes that 10ml, 20ml, 40ml and 100ml are approved.
Decision: The Board approved the case with innovator’s specifications with a filled volume of 50mL
as already approved filled volumes range from 10mL to 100mL.
Pakistan"
Brand Name +Dosage Form + Strength Closxel Injection
Composition " Each ml contains:
Closantel…………..50mg
Levamisole HCl…...100mg
Type of Form Form-5

Me-too status (with strength and dosage Levamiclosan Injection (10ml, 25ml, 50ml, 100ml vial) of
form) M/s Selmore Pharmaceuticals Pvt Ltd, (Reg.# . . 062075)
000519 on Dated: 02-11-2019.
Decision: Approved with innovator’s specfiications.
Pakistan"
Brand Name +Dosage Form + Strength Closxel Injection
Closantel…………..50mg
Levamisole HCl…...100mg
Type of Form Form-5
Me-too status (with strength and dosage Levamiclosan Injection (10ml, 25ml, 50ml, 100ml vial) of
form) M/s Selmore Pharmaceuticals Pvt Ltd, (Reg.# . . 062075)
000519 on Dated: 02-11-2019.
BOLUS SECTION (VET) NEW
NO OF MOLECULES NO PRODUCTS
10 13
Pakistan"
Brand Name +Dosage Form + Strength Albexcel 152 Bolus
Composition “Each bolus contains:
Albendazole……..152 mg”
Pharmacological Group Antiparasitic/ Dewormer
Type of Form Form-5
Pack size & Demanded Price 5’s, 10’s, 50’s and 100’s / Decontrolled
Me-too status (with strength and dosage Albensel-S Bolus 152mg of M/s Selmore Pharmaceuticals
form) Pvt Ltd, (Reg.# 043139)
000519 on Dated: 02-11-2019.
Pakistan"
Composition " Each bolus contains
Albendazole………600 mg"
Type of Form Form-5

Me-too status (with strength and dosage Albensel-C Bolus 600mg of M/s Selmore Pharmaceuticals
form) Pvt Ltd, (Reg.# 043138)
000519 on Dated: 02-11-2019.
Pakistan"
Albendazole……2500 mg"
Type of Form Form-5
Me-too status (with strength and dosage Albensel-2500 Bolus 2500mg of M/s Selmore
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Flumexcel 350 Bolus
Flumequine……….350 mg"
Type of Form Form-5
Me-too status (with strength and dosage Flumequine Bolus 350mg of M/s Zakfas Pharmaceuticals Pvt
form) Ltd, (Reg.# 074754)
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Fenexcel 750 Bolus
Composition "Each bolus contains:
Fenbandazole…….750 mg"
Type of Form Form-5
Me-too status (with strength and dosage Fenbal-Bolus 750mg of M/s Wimits Pharmaceuticals Pvt Ltd,
form) (Reg.# 078319)
000519 on Dated: 02-11-2019.

Pakistan"
Brand Name +Dosage Form + Strength Nicloexcel 1250 Bolus
Niclosamide………1250 Mg"
Type of Form Form-5
Me-too status (with strength and dosage Niclover Bolus 1250mg of M/s Selmore Pharmaceuticals Pvt
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Santexcel 500 Bolus
Composition "Each Bolus contains:
Closantel…….500 Mg"
Type of Form Form-5
Me-too status (with strength and dosage Flukinil Bolus 500mg of M/s Selmore Pharmaceuticals Pvt
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Trileva 99 Bolus
Triclabendazole………900 mg
Levamisole HCl………90 mg"
Type of Form Form-5
Me-too status (with strength and dosage Tribazole Plus Bolus 900mg/90mg of M/s Selmore
000519 on Dated: 02-11-2019.

Pakistan"
Brand Name +Dosage Form + Strength Trissen 1000 Bolus
Trimethoprim………200 mg
Sulphadiazine ……..1000 mg"
Type of Form Form-5
Me-too status (with strength and dosage Tribactral Bolus 200mg/1000mg of M/s Selmore
form) Pharmaceuticals, (Reg.# 029617)
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Suldimexcel 2.5 Bolus
Sulphadimidine Sodium…….2.5 Gm"
Type of Form Form-5
Me-too status (with strength and dosage Sulfapri Bolus 2.5gm of M/s Selmore Pharmaceuticals Pvt
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Vermexcel Bolus
Levamisole HCl……1125 mg
Oxyclozanide………2250 mg"
Type of Form Form-5
Me-too status (with strength and dosage Zanisol Bolus1125mg/2250mg of M/s Prix Pharmaceuticals,
form) (Reg.# 044979)
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Vermout 400 bolus

Levamisole HCl……..400 mg"
Type of Form Form-5
Me-too status (with strength and dosage LEVA 400 BOLUS of M/s Intervac, (Reg.# 072651)
form)
000519 on Dated: 02-11-2019.
Pakistan"
Brand Name +Dosage Form + Strength Vermout 1125 Bolus
Levamisole HCl……..1125 mg"
Type of Form Form-5
Me-too status (with strength and dosage Levasel Bolus 1125mg of M/s Selmore Pharmaceuticals Pvt
000519 on Dated: 02-11-2019.
Case No. 4: Registration Applications of Import Cases.
a. New Cases Human Import

2037. Name and address of Applicant M/s Biocare Pharmaceutical 807 Shadman-1, Lahore, Pakistan.
Detail of Drug Sale License License to sell drugs as Distributor
Address: Biocare Pharmaceuticals, 807 shadman-1, District
Lahore.
Validity: 17/04/2020
The firm has submitted receipt for renewal of DSL dated
15/07/2020.
Product License Holder & Manufacturer & MAH: M/s Reyoung Pharmaceutical Co., Ltd.,
Manufacturer No.1 Ruiyamg Road, Yiyuan County, Shandong Province,
China.
Diary No. & Date of R& I Dy No: 8137 Dated : 25/02/2019
Fee including differential fee Rs: 50,000 Dated : 25/02/2019
Brand Name +Dosage Form + Strength Amomax 3g for injection
Ampicillin sodium equivalent to Ampicillin…….2g
Salbactum sodium equivalent to Salbactum……..1g
Pharmacological Group Penicillin/beta lactamase inhibitor
Shelf life 3 years
Pack size & Demanded Price Rs. 608/- per vial (1’s)
th
International availability Unasyn for injection (2g/1g, 1g/500mg) by M/s Pfizer
USFDA approved.
Me-too status N/A
Stability studies 36 months real time stability and 06 months accelerated
stability study data as per zone IV-A.
Certified by: Yiyuan Food and Drug Administration
Date of issuance: 28/05/2018
Free sale: Yes
GMP status: conformance to WHO-GMP
GMP certificate: Certificate no. SD20180716 valid till
12/06/2023 issued by Shandong Food and Drug
Administration.
Remarks of the Evaluator. Copy of Distributorship & & Agency Agreement Contract is
submitted where REyoung Pharmaceuticsal Co., Ltd., No.1
Ruiyang Road, Yiyuan Couunty Shandong PRC, 256100 China
authorized M/s biocare.
Decision: Approved as per policy for inspection of manufacturer abroad.
2038. Name and address of Applicant M/s Biocare Pharmaceutical 807 Shadman-1, Lahore, Pakistan.
Address: Biocare Pharmaceuticals, 807 shadman-1, District
Lahore.
The firm has submitted receipt for renewal of DSL dated
15/07/2020.
Product License Holder & Manufacturer & MAH: M/s Reyoung Pharmaceutical Co., Ltd.,
Manufacturer No.1 Ruiyamg Road, Yiyuan County, Shandong Province,
China.

Brand Name +Dosage Form + Strength Amomax 1.5g for injection
Ampicillin sodium equivalent to Ampicillin…. 1g
Salbactum sodium equivalent to Salbactum….. 0.5g
Pharmacological Group Penicillin/beta lactamase inhibitor
Shelf life 3 years
Pack size & Demanded Price Rs. 407/- per vial (1’s)
International availability Unasyn for injection (2g/1g, 1g/500mg) by M/s Pfizer
USFDA approved.
Me-too status To be confirmed
Stability studies 36 months real time stability and 06 months accelerated
stability study data as per zone IV-A.
Certified by: Yiyuan Food and Drug Administration
Free sale: Yes
GMP status: conformance to WHO-GMP
GMP certificate: Certificate no. SD20180716 valid till
12/06/2023 issued by Shandong Food and Drug
Administration.
Remarks of the Evaluator. Copy of Distributorship & & Agency Agreement Contract is
submitted where REyoung Pharmaceuticsal Co., Ltd., No.1
Ruiyang Road, Yiyuan Couunty Shandong PRC, 256100 China
2039. Name and address of Applicant M/s Zhangjiakou Dongfang Pharmaceutical Pakistan (private)
Limited, Office no. D-2, 2nd floor, west land trade centre, plot #
c-5, Block 7/8 KCHSU, Shaheed e Millat Road Karachi.
Detail of Drug Sale License Drug license by way of whole sale
Address: Zhangjiakou Dongfang Pharmaceutical Pakistan Pvt.
Ltd. D-2, 2nd floor West Land trade centre plot no. C-5, Block
7/8, KCHSU, Shaheed e Millat road Karachi.
Product License Holder & Manufacturer & MAH:
Manufacturer Reyoung Pharmaceutical Co., Ltd. Workshop 312 from
Reyoung Pharamceutical Co., Ltd., Ruiyang Road, Yiyuan
county, Shandong province, China.
Diary No. & Date of R& I Dy. No 1674 Dated 14/01/2019
Fee including differential fee Rs. 100,000/- Dated 14/01/2019
Brand Name +Dosage Form + Strength Dopra 40mg capsule
Omeprazole (extended release pellets)……40mg
Shelf life 3 years
Pack size & Demanded Price Rs. 27/- per Cap
International availability Losec Capsule 40mg by M/s Astra Zaneca (MHRA Approved)
Me-too status Meprascot Capsules 40mg by M/s Scotmann Pharmaceuticals
(Reg#028239)
Stability studies 6 months accelerated and 36 months long term data as per zone
IV-A provided by the firm.
Detail of certificates attached Original legalized Free Sale Certificate
Certificate No: 2018-0908
Certified by: Yiyuan County Food & Drug Administration
Date of issuance: 08/09/2018 (valid for 5 years)
20mg and 40mg omeprazole capsules are freely sold in the
exporting country.
GMP certificate: SD201880652, valid till 29/01/2023, issued
by Shandong food and drug administration
Remarks of the Evaluator. Sole agency agreement is required.
Free sale certificate is issued by authority not recognized by
WHO.
Decision: Deferred for submission of sole agency agreement/letter of authorization and
confirmation of zone stability under stability studies were conducted..
2040. Name and address of Applicant M/s Zhangjiakou Dongfang Pharmaceutical Pakistan (private)
Limited, Office no. D-2, 2nd floor, west land trade centre, plot #
c-5, Block 7/8 KCHSU, Shaheed e Millat Road Karachi.
Detail of Drug Sale License License to sell drugs as a Distributor
Address:
Validity:
Manufacturer Reyoung Pharmaceutical Co., Ltd. Workshop 312 from
Reyoung Pharamceutical Co., Ltd., Ruiyang Road, Yiyuan
county, Shandong province, China.
Brand Name +Dosage Form + Strength Dopra 20mg capsule
Omeprazole (extended release pellets)..……20mg
Shelf life 3 years
Pack size & Demanded Price Rs. 20/- per Cap
International availability Losec Capsule 20mg by M/s Astra Zaneca (MHRA Approved)
Me-too status Meprascot Capsules 20mg by M/s Scotmann Pharmaceuticals
(Reg#028238)
Stability studies 6 months accelerated and 36 months long term data as per zone
IV-A provided by the firm.
Detail of certificates attached Original legalized Free Sale Certificate
Certificate No: 2018-0908
Certified by: Yiyuan County Food & Drug Administration
Date of issuance: 08/09/2018 (valid for 5 years)
20mg and 40mg omeprazole capsules are freely sold in the
exporting country.
GMP certificate: SD201880652, valid till 29/01/2023, issued
by Shandong food and drug administration
Remarks of the Evaluator. Original sole agency agreement is required.
Free sale certificate is issued by authority not recongnized by
WHO.
Decision: Deferred for submission Sole Agency Agreement/letter of authorization.
2041. Name and address of Applicant M/s Aster Life Sciences, 32 Babar block, New Garden Town,
Lahore.
Address: Aster Life Sciences 32-Baber block, New Garden
Town, District Lahore.
The firm has submitted receipt for renewal of DSL
25/11/2019.
Manufacturer M/s Jeil Pharmaceutical Co., Ltd., 7 Cheongganggachang-ro
Baegam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do,
Republic of Korea.
Name of exporting country Korea
Brand Name +Dosage Form + Strength Newropenem Injection 500mg IV
Meropenem as trihydrate…..500mg
Shelf life 3 years
International availability Meropenem 500 mg powder for solution for injection or
infusion by M/s Milpharm Limited, MHRA Approved.
Me-too status Mopen 500mg Injection by M/s Hilton pharma, Reg. No.
36429.
Stability studies 24 months long term and 06 month accelerated stability data
according to the conditions of zone IV-A.
Certificate No: 2018-D1-1738
Certified by: Gyeongin Regional Food and Drug
Administration
Free sale: Yes
GMP status: The manufacturer conforms to WHO and PIC/s
GMP as per CoPP
GMP certificate: Expired (validity May 17, 2020), issued by
Ministry of Food and Drug Safety, Korea.
Remarks of the Evaluator. Justification is required since 2% overage is added in the
formulation as per submitted dossier.
As per submitted CoPP, the formulation contains
“Meropenem Hydrate” while the product approved in reference
regulatory authorities contains “Meropenem As Trihydrate” as
well as USP describes the assay of the product in terms of base
only (Meropenem as trihydrate), clarify.
Decision: As the CoPP describes the composition of the applied fromulation the formulation contains
“Meropenem Hydrate” while the product approved in reference regulatory authorities contains
“Meropenem As Trihydrate”, therefore the Board decided to deferred the case for clarification of salt
form.
2042. Name and address of Applicant M/s Aster Life Sciences , 32 Babar block, New Garden Town,
Lahore.
Address: Aster Life Sciences 32-Baber block, New Garden
Town, District Lahore.
The firm has submitted receipt for renewal of DSL
25/11/2019.
Manufacturer M/s Jeil Pharmaceutical Co., Ltd., 7 Cheongganggachang-ro
Baegam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do,
Republic of Korea.
Brand Name +Dosage Form + Strength Newropenem Injection 1g IV
Meropenem as trihydrate…..1g
Shelf life 3 years
International availability Meropenem 1g powder for solution for injection or infusion by
M/s Hikma, MHRA Approved.
Me-too status Mopen 1g Injection by M/s Hilton pharma, Reg. No. 36427.
Stability studies 24 months long term and 06 month accelerated stability data
according to the conditions of zone IV-A.
Certificate No: 2018-D1-1736
Certified by: Gyeongin Regional Food and Drug
Administration
th
Free sale: Yes
GMP status: The manufacturer conforms to WHO and PIC/s
GMP as per CoPP
GMP certificate: Expired (validity May 17, 2020), issued by
Ministry of Food and Drug Safety, Korea.
Remarks of the Evaluator. Justification is required since 2% overage is added in the
formulation as per submitted dossier.
As per submitted CoPP, the formulation contains
“Meropenem Hydrate” while the product approved in reference
regulatory authorities contains “Meropenem As Trihydrate” as
well as USP describes the assay of the product in terms of base
only (Meropenem as trihydrate), clarify.
Decision: As the CoPP describes the composition of the applied formulation the formulation contains
“Meropenem Hydrate” while the product approved in reference regulatory authorities contains
“Meropenem As Trihydrate”, therefore the Board decided to defer the case for clarification of salt
form.
2043. Name and address of Applicant M/s Scilife Pharma (pvt) Limited, Plot # FD-57/58-A2,
Korangi Creek Industrial Park (KCIP) Karachi
Detail of Drug Sale License Drug license by way of wholesale
Address: Scilife pharma (pvt) Ltd, P no. FD-57/58-A2,
Korangi creek industrial park (KICP) Karachi.
Manufacturer M/s Laboratorio Eczane Pharma S.A, Laprida 43, Avellaneda,
Buenos Aires, Argentina.
Name of exporting country Argentina
Brand Name +Dosage Form + Strength Xelotab 500mg tablet
Capecitabine………..500mg
Pharmacological Group Antineoplastic
Pack size & Demanded Price 2083.3/- per 10’s, 6250/- per 30’s, 12500/- per 60’s, 25000/-
per 120’s
International availability Capecitabine 500 mg film-coated tablets by M/s Glenmark
Pharmaceuticals Europe Limited, MHRA Approved.
Me-too status MERICAP 500MG film coated tablet by M/s Merixil pharma,
Reg. No. 81801
Stability studies 24 months data for real time and 6 months of accelerated data.
Detail of certificates attached Original CoPP
Certified by: National Institute of drugs
Free sale: Yes
GMP status: The facilities and operations conform to WHO-
GMP as per CoPP.

Remarks of the Evaluator. Legalization of the submitted CoPP is done on a separate
certificate containing content in Spanish language. The firm has
provided the official weblink for verification of legalization. The
content that is present on the legalized certificate is verifiable
from the website but it does not establish any relation of the
legalized certificate with the CoPP. The description of one the
certificate (translated by google translate) is given in the
following.
The Legalization Coordination Unit of the Ministry of Foreign
Affairs and Worship certifies that the signature
that appears in this document: CERTIFICADO DE ANMAT
and says Matias Ezequiel GOMEZ (MINISTRY OF
HEALTH) is similar to the one in your records.
Holder / s of the document: LABORATORIO ECZANE
PHARMA SA
Order No: 16598/2020
Tariff: 6.12.3
Amount: ARS 300/-
Date: 01/20/2020
Observations
Decision: Deferred for review of stability data as per Zone IVA
2044. Name and address of Applicant M/s Zam Zam Pharmaceutical, Suit No. 205,206, Beaumont
Plaza, 6-CL-10, Beaumont Road, Karachi, Pakistan.
Detail of Drug Sale License Drug license by way of Wholesale
Address: Zam Zam Pharmaceutical , Suit no. 16 Beaumont
Road Karachi.
Product License Holder & Manufacturer (Primary and secondary packaging):
Manufacturer M/s Haupt Pharma amareg GmbH Donaustaufer Strasse 378
DE-93055 Regemsburg, Germany
Analysis and batch release:
M/s Medinova AG Eggbuhlstrasse 28 Zurich, Switzerland
Product License Holder:
Medinova AG Eggbuhlstrasse 28 CH-8050 Zurich
Switzerland
Name of exporting country Switzerland
Rs. 5,000/- dated 19/05/2020 for change of product license
holder.
Brand Name +Dosage Form + Strength Gynoflor Vaginal tablets
Composition Each vaginal tablet contains:
Lactobacillus acidophilus………100million cfu
Estriol…………………………...0.03mg
Finished Product Specification Innovators
Pharmacological Group Gynecological anti-infective and antiseptic
Pack size & Demanded Price 1 blister of 6 vaginal tablets, Rs. 1875.
International availability Approved in Switzerland as per CoPP and the approval status
has been verified from official website.
Gynoflor vaginal tablet by M/s medinova, Swissmedic
Stability studies 36 months data of 3 batches at 5oC 3oC, 60% , Real Time
o o
06 months data of 3 batches at 25 C 3 C, 60% ,
Acelerated

Certified by: Swissmedic
Free sale: yes
GMP status: conforms to WHO-GMP
Copy of Distribution agreement is submitted. M/s Medinova
AG, Switzerland confirms M/s Zam Zam Pharmaceutical as
the exclusive distributor for Pakistan.
Remarks of the Evaluator. Lactobaccilus bacilus is a living organism, therefore the
content of lactobacillus aciophilus in lyophilisate may vary
within the specifications.
Manufacturing:
1. Manufacturing of Premix of estriol with cellulose
2. excipients + Acidophilus bacillus lyphilisate
Resultant mixtures from both steps ar then finally mixed and
compressed.
Decision: Referred to Committee constituted by DRAP for determining therapeutic group.
2045. Name and address of Applicant M/s Genome Pharmaceuticals Pvt. Ltd. House # 166-A,
Street#9, Chaklala Scheme III, Rawalpindi
Detail of Drug Sale License License to sell drugs as distributor No. 0011000 0002403
valid upto 28-Aug-2020.
Name and address of manufacturer & M/s SPAL Private Limited Plot No. 12, Biotech Park Phase-II,
marketing authorization holder Lalgadi Malakpet, Shameerpet, Medchal-Malkajgiri District,
Telangana State-500101, India
Name of exporting country India
Brand Name +Dosage Form + Strength SPDROX 500mg capsule
Hydroxyurea ……………500mg
Pharmacological Group antineoplastic (anti-cancer)
International availability Hydroxycarbamide medac 500 mg capsule, hard (Germany)
Me-too status HYDREA CPASULES 500MG of M/s BRISTOL MYERS
SQUIBB
Stability studies Firm has submitted long term (24 months) at 30+2oC,
65+5%RH & accelerated (06 months) stability data at 40+ 2oC,
75+ 5% RH for three batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 12230/E(M)/TS/2018)
issued on 02-10-2018 by Drug Control Administration Govt. of
Telangana declaring the free sale of applied product and GMP
compliant status of the manufacturer i.e., M/s SPAL Private
Limited This certificate is valid until 28-09-2020.
Copy of sole agency agreement is submitted.
2046. Name and address of Applicant M/s Genome Pharmaceuticals Pvt. Ltd. House # 166-A,
Street#9, Chaklala Scheme III, Rawalpindi
Detail of Drug Sale License License to sell drugs as distributor No. 0011000 0002403
valid upto 28-Aug-2020.

Name and address of manufacturer & M/s SPAL Private Limited Plot No. 12, Biotech Park Phase-II,
marketing authorization holder Lalgadi Malakpet, Shameerpet, Medchal-Malkajgiri District,
Telangana State-500101, India
Brand Name +Dosage Form + Strength SP GEF 250mg tablet
Gefitinib………250mg
Finished Product Specification Firm claim in-house specifications of applied product
Pharmacological Group Anticancer
International availability Gefitinib 250 mg film-coated tablets of M/s Cipla (Eu) Ltd.,
(MHRA approved)
Stability studies Firm has submitted long term (24 months) at 30+2oC,
65+5%RH & accelerated (06 months) stability data at 40+ 2oC,
75+ 5% RH for three batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 12230/E(M)/TS/2018)
issued on 02-10-2018 by Drug Control Administration Govt. of
Telangana declaring the free sale of applied product and GMP
compliant status of the manufacturer i.e., M/s SPAL Private
Limited This certificate is valid until 28-09-2020.
Remarks of the Evaluator. Me too status could not be confirmed.
Decision: Approved with Innovator’s specifications as per Policy for inspection of Manufacturer
abroad.
2047. Name and address of Applicant M/s A.J.Mirza Pharma Pvt. Ltd. 1st floor shafi court,
Merewether road, civil lines, Karachi
Detail of Drug Sale License Address: M/s A.J.Mirza Pharma Pvt. Ltd. 1st floor shafi court,
Merewether road, civil lines, Karachi Validity: 24-12-2018 to
23-12-2020
Status: Drug License by way of WholeSale.
Name and address of manufacturer M/s Cipla Ltd. S-103 to S-105 S-107 to S-112, L-147, L-147/1
to L-147/3, L-138 & L147/A, Verna Industrial estate, Verna
Goa India.
Name and address of marketing M/s Cipla Ltd. S-103 to S-105 S-107 to S-112, L-147, L-147/1
authorization holder to L-147/3, L-138 & L147/A, Verna Industrial estate, Verna
Goa India.
Fee including differential fee Rs. 100,000/- Dated 25-08-2014 copy attached.
Brand Name +Dosage Form + Strength Cytodrox Hydroxyurea Capsules USP 500mg
Composition Each capsule Contains:
Hydroxyurea…….500mg
Shelf life 36 months: Store below 30oC.
Pack size & Demanded Price 10’s & As per DPC
International availability Hydrea 500 mg Hard Capsule by M/s Bristol myer, MHRA
Approved.
Me-too status Uro-Z 500mg Capsule by M/s Zjans Pharma, Reg. No. 26792
Stability studies Firm has submitted long term (36 months) at 30oC &
accelerated (06 months) stability data at 40oC, 75+ 5% RH for
three batches.
Detail of certificates attached Legalized and valid copy of CoPP Certificate No.
789.MFG/WHO-GMP/DFA/2019/164(2) valid till 19/02/2022
is submitted. The product is available I for free sale in country
of origin and the manufactuere conforms to WHO-GMP as per
CoPP.
Copy of agreement is attached.
Remarks of the Evaluator. i. Photocopy of fee challan form is attached.
Decision: Approved with as per Policy for inspection of Manufacturer abroad. Board further
decided that verification of fee challan may be done as per decision of 285th meeting of Registration
Board.
2048. Name and address of Applicant M/s Bristol Mayer Biotech Pakistan, 73-B Guldashat town, zarrar
Shaheed road, District Lahore
Detail of Drug Sale License License to Sell Drug as Distributor No. 0011000 0001679 valid
upto 07-Apr-2020
Address: 73-B Guldashat town, Zarrar Shaheed Road, District
Lahore.
*the firm has submitted receipt for renewal of license.
Product License Holder & M/s S.C. Magistra C&C S.R.L 82A Aurel Vlaicu blvd., Constanta,
Manufacturer code 900055, Romania
Name of exporting country Romania
Diary No. & Date of R& I Dy. No. 7571 Dated 28-02-2018
Fee Rs. 50,000/- Dated 28-02-2018
Brand Name +Dosage Form + Contracept M 18.9mg Pessary
Strength
Composition Each pessary contains:
Benzalkonium chloride……18.9mg
Pharmacological Group Act code G02BBN2 Local contraceptives
Pack size & Demanded Price 10’s commercial unit & As per SRO
International availability Could not be confirmed
Stability studies Firm has submitted long term (24 months) at 30oC±20C,
65%RH±5%RH & accelerated (06 months) stability data at 40oC,
75% RH of three batches
Detail of certificates attached Legalized and valid copy of CoPP (Certificate#. 5487) issued on 11-
10-2017 by Ministry of Health, National Agency for Medicines and
Medical Devices declaring the free sale of applied product and GMP
compliant status of the manufacturer.
Copy of Original Notarized “Product specific Letter of Authorization”
from M/s VEM Llac San. Ve Tic. A.S in the name of M/s Bristol
Mayer Biotech Pakistan dated 07-06-208 valid for 2 years is submitted
Remarks of the Evaluator. i. The product license holder as per letter of authorization/sole agency
agreement is not same as mentioned in CoPP.
ii. Evidence of approval of applied formulation in reference
iii. Evidence of applied formulation/drug already approved by DRAP

Decision: Deferred for the submission of following;
 Calrification is required since the product license holder as per letter of authorization/sole agency
agreement is not same as mentioned in CoPP.
 Evidence of approval of applied formulation in reference regulatory authorities / agencies which
 Clarification of DSL details since Form-5A is from M/s Bristol Mayer Biotech whereas renewal
application submitted is for M/s. B.M Biotech
b. Deferred Cases (Human) Import

2049. Name and address of Applicant M/s Scilife Pharma (Pvt.) Limited Plot # FD-57/58-A2, Korangi Creek
Industrial park (KCIP) Karachi
Address: Scilife pharma (pvt) Ltd, P no. FD-57/58-A2, Korangi creek
industrial park (KICP) Karachi.
Manufacturer & Marketing M/s Laboratorio Eczane Pharma S.A. Laprida 43, Avellaneda (1870),
authorization holder Buenos Aires Argentina
Brand Name +Dosage Form + DASANIB 70mg Tablet
Strength
Dasatinib…….70mg (as Dasatinib monohydrate 72.58mg)
Pharmacological Group ANTINEOPLASTIC AGENTS, L01XE Protein kinase inhibitors
Shelf life 24 Months store below 300C
Pack size 60’s
International availability SPRYCEL 70mg (USFDA)
Me-too status SPRYCEL 70MG TABLETS of M/s BRISTOL-MYERS SQUIBB,
Stability studies Firm has submitted long term (36 months) at 30oC±20C, 65±5%RH &
accelerated (06 months) stability data at 40oC, 75% RH for three
batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 20132019 000767 18) dated
28August 2018 by National Institute of Medicines- National Institute of
Drugs Caseros Avenue 2161 Autonomous City of Buenos Aires
Argentine Republic declaring the no free sale of applied product in the
exporting country.
Valid for twelve months
Copy of Sole agency agreement provided.
Remarks of the Evaluator. Submitted CoPP shows that Product is not actually on the market in the
exporting country. Firm reply as under:
“The manufacturer has taken exclusive registration of these products
with brand name for export market only, reasoning which the said
product is not available in exporting country”
Decision of 293rd meeting: Deferred for clarification regarding non availability of product in country of
origin as per submitted CoPP.
Submission by the firm: The firm has submitted Original and Valid CoPP (certificate No. 191910) issued
by National institute of Drugs Argentina on 09/01/2020. The applied product is available for free sale in
the country and the operations and facilities conform to WHO-GMP.
Legalization of the submitted CoPP is done on a separate certificate containing content in Spanish language.
The firm has provided the official weblink for verification of legalization. The content that is present on the

legalized certificate is verifiable from the website but it does not establish any relation of the legalized
certificate with the CoPP. The description of the certificate (translated by google translate) is given in the
following.
The Legalization Coordination Unit of the Ministry of Foreign Affairs and Worship certifies that the
signature that appears in this document: CERTIFICADO DE ANMAT and says Matias Ezequiel GOMEZ
(MINISTRY OF HEALTH) is similar to the one in your records.
Holder / s of the document: LABORATORIO ECZANE PHARMA SA
Order No: 16599/2020
Tariff: 6.12.3
Amount: ARS 300 -
Date: 01/20/2020
Observations
abroad.
2050. Name and address of Applicant M/s Scilife Pharma (Pvt.) Limited Plot # FD-57/58-A2, Korangi
Creek Industrial park (KCIP) Karachi
Address: Scilife pharma (pvt) Ltd, P no. FD-57/58-A2, Korangi
creek industrial park (KICP) Karachi.
Name and address of M/s Laboratorio Eczane Pharma S.A. Laprida 43, Avellaneda (1870),
manufacturer Buenos Aires Argentina
Marketing authorization holder M/s Laboratorio Eczane Pharma S.A. Laprida 43, Avellaneda (1870),
Buenos Aires Argentina
Brand Name +Dosage Form + TEMO 100mg Capsule (Temozolomide)
Strength
Temozolomide………………100mg
Pharmacological Group ATC Code L01AX03 alkylating agents (Anticancer)
Shelf life 36 Months below 300C
Pack size 5’s
International availability Temozolomide (USFDA)
Me-too status Temoeirgen 100Mg Capsules of M/s Merixil Pharma
Stability studies Firm has submitted long term (36 months) at 30oC±20C, 65±5%RH
& accelerated (06 months) stability data at 40oC, 75% RH for three
batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 05/18/124543) dated
28August 2018 by National Institute of Medicines- National Institute
of Drugs Caseros Avenue 2161 Autonomous City of Buenos Aires
Argentine Republic declaring the no free sale of applied product in
the exporting country.
Sole agency agreement provided.
Remarks of the Evaluator. Submitted CoPP shows that Product is not actually on the market in
the exporting country. Firm reply as under:
Decision of 291st meeting of Registration Board:
Deferred for clarification regarding non availability of product in country of origin as per
submitted CoPP.

“Now the firm has submitted a copy of letter with English translation from Argentine Republic National
Executive Power which shows that “Section 1: To authorize Laboratorio Eczane Pharma S.A to market
the Medicinal product Temoxan/Temozolomide 100mg – 250mg Dosage form capsule; certificate no.
57.414, which will be manufacturer at Laboratorio Eczema Pharma S.A., Laprida 431, Avellaneda,
Buenos Aires Province, Argentine Republic”.
Decision:
Decision of 293rd meeting: Deferred for clarification regarding non availability of applied product in
country of origin as per submitted CoPP.
by National instititute of Drugs Argentina on 09/01/2020. The applied product is available for free sale in
certificate with the CoPP. The description of the certificate (translated by google translate) is given in the
following.
Order No: 16598/2020
Tariff: 6.12.3
Amount: ARS 300 .-
Date: 01/20/2020
Observations
abroad.
2051. Name and address of Applicant M/s Scilife Pharma (Pvt.) Limited Plot # FD-57/58-A2, Korangi
Creek Industrial park (KCIP) Karachi
Details of Drug sale license Drug license by way of Wholesale
Address: Scilife pharma (pvt) Ltd, P no. FD-57/58-A2, Korangi
creek industrial park (KICP) Karachi.
Name and address of M/s Laboratorio Eczane Pharma S.A. Laprida 43, Avellaneda (1870),
manufacturer Buenos Aires Argentina
Marketing authorization holder M/s Laboratorio Eczane Pharma S.A. Laprida 43, Avellaneda (1870),
Buenos Aires Argentina
Brand Name +Dosage Form + TEMO 250mg Capsule (Temozolomide)
Strength
Temozolomide………………250mg
Pharmacological Group ATC Code L01AX03 alkylating agents (Anticancer)
Shelf life 36 Months below 300C
Pack size 5’s
International availability Temozolomide (USFDA)
Me-too status Temonat 250mg Capsules of M/s Hakimsons
Stability studies Firm has submitted long term (36 months) at 30oC±20C, 65±5%RH
& accelerated (06 months) stability data at 40oC, 75% RH for three
batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 05/18/124543) dated
28August 2018 by National Institute of Medicines- National Institute
of Drugs Caseros Avenue 2161 Autonomous City of Buenos Aires
Argentine Republic declaring the no free sale of applied product in
the exporting country.
Sole agency agreement provided.
Remarks of the Evaluator. Submitted CoPP shows that Product is not actually on the market in
the exporting country. Firm reply as under:
Decision of 291st meeting of Registration Board:
Deferred for clarification regarding non availability of product in country of origin as per
submitted CoPP.
“Now the firm has submitted a copy of letter with English translation from Argentine Republic National
Executive Power which shows that “Section 1: To authorize Laboratorio Eczane Pharma S.A to market
the Medicinal product Temoxan/Temozolomide 100mg – 250mg Dosage form capsule; certificate no.
57.414, which will be manufacturer at Laboratorio Eczema Pharma S.A., Laprida 431, Avellaneda,
Buenos Aires Province, Argentine Republic”
Decision of 293rd meeting: Deferred for clarification regarding non availability of applied product in
country of origin as per submitted CoPP.
by National instititute of Drugs Argentina on 09/01/2020. The applied product is available for free sale in
certificate with the CoPP. The description of one certificate (translated by google translate) is given in the
following.
Order No: 16597/2020
Tariff: 6.12.3
Amount: ARS 300 .-
Date: 01/20/2020
Observations
Decision: Approved with innovator’s specifications as per Policy for inspection of Manufacturer
abroad.
2052. Name and address of Applicant M/s Bristol Mayer Biotech Pakistan, 73-B Guldashat town, zarrar
Shaheed road, District Lahore
Detail of Drug Sale License License to Sell Drug as Distributor No. 0011000 0001679 valid
upto 07-Apr-2020
Product License Holder & M/s VEM Llac San. Ve Tic. A.S.
Manufacturer Factory address: Cerkezkoy Organize Sanayi Bolgesi Karaagac
Mahallesi. Fatih Bulvari. No: 38 Kapakli/ TEKIRDAG/TURKEY
Fee including differential fee

Rs : 50,000 Dated : 21/05/2018 + Rs : 50000
:Dated: 16-10-2019
Brand Name +Dosage Form + Candisept 100mg/50ml I.V Solution for Infusion
Strength
Composition Each 50ml Vial Contains
Fluconazole ……100mg

International availability Fluconazole 2mg/ml Solution for Infusion (USFDA)
Me-too status Lumen 2mg/Ml Injection (50ml) Of M/S Nimrall
Farma (Reg # 039823)
Stability studies
Product license and date of issue : 254/16 _05.11.2013
Free sale: Free sale of the product in exporting
country:
GMP certificate:
07-06-2018
Validity: 2 Years
Remar Deficiencies/Shortcomings Reply by Firm
ks of Remaining fee of Rs:50000/- as Remaining fee of Rs:50000/-
the product is already registered in Submitted. Deposit slip No#
Evalua Pakistan. 1914215 Dated: 16-10-2019
tor. Justify use of Type II glass as According to the European Pharmacopoeia “3.2.1 Glass
primary packaging material while in Containers for Pharmaceuticals Use” Type II glass
reference agency Type I glass is containers are suitable for most acidic and neutral
used as primary packaging material. ,aqueous preparations whether or not for parenteral
administration. Our product is near neutral and aqueous
solution. Therefore, Type II glass is suitable for this
product.
Decision of 293rd meeting:
Deferred for Clarification/Justification on scientific grounds for use of Type II glass container
as primary packaging material for applied formulation or otherwise evidence of reference
product packed in Type II glass container.
Evaluation by PEC:
The firm has provided the reference of the following product approved by MHRA which has
been verified with following details;
Fluconazole 2 mg/ml Solution for Infusion
2. Qualitative and quantitative composition
50 ml/100 ml glass vials:
1 ml solution for infusion contains 2 mg of fluconazole.
6.5 Nature and contents of container
Glass vials:
Clear type I or II glass vial, sealed with chlorobutyl rubber stopper and sealed with a flip-off aluminium cap.
The official website was accessed on 29/06/2020.
https://mhraproductsproduction.blob.core.windows.net/docs/c10d2a9d32a84c9c845161dedc2e587247c0
ff58

Decision: Deferred for clarification of DSL details since Form-5A is from M/s Bristol Mayer Biotech
whereas renewal application submitted is for M/s. B.M Biotech
2053. Name and address of Applicant M/s Punjab Medical Services, Office No. 4/5 2. Floor Jalal Center
Opp. OPC Gme Gangaram Hospital Mozang Road Lahore
Detail of Drug Sale License Address: Punjab Medical Services Office No. 4/5 Jalal Center
Opp. OPD Gate sir Ganga ram Hospital Mozang Road Lahore
License to sell drugs as a Distributor No. 0011000 0002884 Valid
upto 27th Feb. 2021
Name and address of manufacturer M/s Mefar Ilac Sana YII A.S., Ramazanoglu Mah. Ensar Cad No:
20, Kurtkoy, Pendik, Istanbul, 34906, Turkey
Name and address of marketing M/s Pharmathen International S.A, International Park Sapes
authorization holder Rodopi Prefecture, Block No 5, Rodopi, 69300, GREECE
Name of exporting country Greece
Brand Name +Dosage Form + CASPO PMS, Powder for concentrate for solution for infusion,
Strength 50mg/vial
Composition Caspofungin Acetate 55.52mg eq. to Caspofungin……50mg
Pharmacological Group Antimycotics for systemic use
Pack size 1’s
International availability CANCIDAS® 50 mg powder for concentrate for solution for
infusion (Netherland)
Me-too status Not available
Stability studies Firm has submitted long term (24 months) at 5±3oC & accelerated
(06 months) stability data at 25+ 2oC for three batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 129338) dated 09-01-2019
by National Organization for Medicines (EOF) 284 Mesogeion
Ave. 15562 Holargos Attica, Greece declaring the free sale of
applied product and GMP compliant status of the manufacturer
i.e., M/s Mefar Ilac Sanayi A.S. Ramazanoglu Mah. Ensar Cad.
No: 20 34906 Kurtkoy-Pendik/ Istanbul
Original product specific Letter of Authorization dated 8th January
2019 to importer M/s Punjab Medical Services with Product
License Holder M/s Pharmathen Global B.V. located at Van
Heuven Goedhartlaan 9, 1181 LE, Amstelveen, Netherlands
Remarks of the Evaluator. As per CoPP product license holder M/s Pharmathen International
S.A, International Park Sapes Rodopi Prefecture, Block No 5,
Rodopi, 69300, GREECE but letter of authorization from M/s
Pharmathen Global B.V. located at Van Heuven Goedhartlaan 9,
1181 LE, Amstelveen, Netherlands.
Initially in form 5A firm have mentioned “do not store above 300C
while submitted real time stability data at 2-80C. now firm submit
revised form-5A without any fee.
Decision of 293rd meeting: Deferred for submission of Letter of Authorization from Product License
Holder.
The firm ha submitted copy of Letter of Authorization, the contents of which are similar to that of letter
of authorization submitted earlier except the name of and address of the authorizing agen i.e M/s
Pharmathen International S.A located at industrial park sapes rodopi prefecture, block number 5, ropdopi
69300, Greece instead of M/s Pharmathen Global B.V. located at Van Heuven goedhartlaan 9, 1181
le,Amstelveen, Netherland.

It is also pertinent to mention that the signing authority on both the letters is same. Moreover, the stamp
on the letter submitted earlier clearly mentions Amsterdem while the stamp on recently submitted letter is
not clear to verify the contents.
Decision: Deferred for further deliberation regarding authenticity of submitted documents.
2054. Name and address of Applicant M/s Punjab Medical Services Office No. 4/5 2. Floor Jalal Center
Opp. OPC Gme Gangaram Hospital Mozang Road Lahore
Detail of Drug Sale License Address: Punjab Medical Services Office No. 4/5 Jalal Center
Opp. DPO Gate sir Ganga ram Hospital Mozang Road Lahore
License no: 05-352-0063-041061D valid upto 27th Feb. 2021
Name and address of manufacturer M/s Mefar Ilac Sana YII A.S., Ramazanoglu Mah. Ensar Cad No:
20, Kurtkoy, Pendik, Istanbul
Name and address of marketing M/s Pharmathen International S.A, International Park Sapes
authorization holder Rodopi Prefecture, Block No 5, Rodopi, 69300, GREECE
Name of exporting country Greece
Brand Name +Dosage Form + CASPO PMS, Powder for concentrate for solution for infusion,
Strength 70mg/vial
Composition Caspofungin Acetate 77.69mg eq. to Caspofungin……70mg
Pharmacological Group Antimycotics for systemic use
Pack size 1’s
International availability CANCIDAS® 70 mg powder for concentrate for solution for
infusion (Netherland)
Me-too status Not Available
Stability studies Firm has submitted long term (24 months) at 5±3oC & accelerated
(06 months) stability data at 25+ 2oC for three batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 129337) dated 08-01-2019
by National Organization for Medicines (EOF) 284 Mesogeion
Ave. 15562 Holargos Attica, Greece declaring the free sale of
applied product and GMP compliant status of the manufacturer
i.e., M/s Mefar Ilac Sanayi A.S. Ramazanoglu Mah. Ensar Cad.
No: 20 34906 Kurtkoy-Pendik/ Istanbul
Original product specific Letter of Authorization dated 8th January
2019 to importer M/s Punjab Medical Services with Product
License Holder M/s Pharmathen Global B.V. located at Van
Heuven Goedhartlaan 9, 1181 LE, Amstelveen, Netherlands
Remarks of the Evaluator. As per CoPP product license holder M/s Pharmathen International
S.A, International Park Sapes Rodopi Prefecture, Block No 5,
Rodopi, 69300, GREECE but letter of authorization from M/s
Pharmathen Global B.V. located at Van Heuven Goedhartlaan 9,
1181 LE, Amstelveen, Netherlands.
Initially in form 5A firm have mentioned “do not store above 300C
while submitted real time stability data at 2-80C. now firm submit
revised form-5A without any fee.
Decision of 293rd meeting: Deferred for submission of Letter of Authorization from Product License
Holder.
The firm ha submitted copy of Letter of Authorization, the contents of which are similar to that of letter
of authorization submitted earlier except the name of and address of the authorizing agen i.e M/s
Pharmathen International S.A located at industrial park sapes rodopi prefecture, block number 5, ropdopi
69300, Greece instead of M/s Pharmathen Global B.V. located at Van Heuven goedhartlaan 9, 1181
le,Amstelveen, Netherland.

It is also pertinent to mention that the signing authority on both the letters is same. Moreover, the stamp
on the letter submitted earlier clearly mentions Amsterdem while the stamp on recently submitted letter is
not clear to verify the contents.
Decision: Deferred for further deliberation regarding authenticity of submitted documents.
2055. Name and address of Applicant M/s Mehran International 498 C Hume Road Quaideen Colony
Opp: World Map Near 3 Star Hall Karachi-Pakistan
Manufacturer & Product License M/s Hebei New Century Pharmaceutical Co. Limited 189 Taihang
Holder Street, Hi-tech zone Shijiazhuang, Hebei, P.R.China
Brand Name +Dosage Form + Cefquinome Oral Suspension 2.5% 100ml
Strength
Cefquinome sulfate…………….25mg
Finished Product Specification Firm claim innovators specification
Pharmacological Group fourth-generation cephalosporin antibiotic
Shelf life 3 years
Pack size 1x100ml bottle Oral Suspension
RRA status Combactan of MSD USA
for three batches.
Detail of certificates attached Copy of CoPP is submitted
Copy of Provided Sole agency agreement with M/s NINHUA
Group Co., Ltd, 21 Jiangxia st. Ningbo, P.R. China which is sole
and exclusive exporting subjected products of the manufacturer in
Pakistan and manufacturer shall not sell the above-mentioned
items to Pakistan marketed by itself or through any other third
parties.
Decision of 293rd meeting: Deferred for submission of original legalized CoPP from concerned
regulatory Authority of exporting country.
The firm has submitted original legalized CoPP (no.2019121601) issue dby Agricultural office of
Shijiazhuang High-tech zone, China on 16/12/2019. The product is available in free sale. The facilitie and
operations conform to WHO-GMP.
abroad.
Miscellaneous deferred cases of Import (Human)

Registration Board in 295th meeting had decided to defer the below mentioned 5 cases and decided that the Secretary
Registration Board will confirm from the manufacturer (M/a Shanxi PUDE Pharmaceutical Co., Ltd., MAH Holder)
via email regarding the authenticity of submitted stability data. Accordingly, the Secretary Registration Board
communicated with the firm regarding the submitted stability data of relevant batches.
The reply received from the relevant firm is being reproduced hereby before the Board.
1.
---------- Forwarded message ---------
From: 普德 <pudepharma@yeah.net>
Date: Thu, 3 Sep 2020, 12:46 pm
Subject: Confirmation of Authenticity of Stability Data
To: <abroabdullah@gmail.com>
Dear Abdullah,
Thanks for your email. We confirmed stability data of products for the batches mentioned in below mentioned
table is true.
Sr.# Brand name & Composition Stability Batch No. &
Manufacturing Date
1. METHOTREXATE for IV injection 50mg/vial Batch No: 1845027
Mfg date: June 5, 2017
Each vial contains: Methotrexate…. 50mg Batch No: 1845028
Batch No: 1845029
Mfg date: July 09, 2017
Batch No: 19456622
Mfg date: Aug 15, 2017
Batch No: 2010102
4. VINORELBINE 10mg Lyophilized powder for injection Batch No: 21000401
Mfg date: Sep 15, 2017
Each vial contains: Vinorelbine Tartrate Eq. to Batch No: 21000402
Vinorelbine….. 10mg Mfg date: Sep 16, 2017
Batch No: 21000403
Mfg Date: Sep 17, 2017
5. VINORELBINE 50mg Lyophilized powder for injection Batch No: 21000404

Mfg date: Sep 18, 2017.
Each vial contains: Batch No: 21000405
Vinorelbine Tartrate Eq. to Vinorelbine….. 50mg Mfg date: Sep 19, 2017.
Batch No: 21000406
Mfg Date: Sep 19, 2017.
Best regards
Shanxi PUDE Pharmaceutical Co., Ltd
Submitted for consideration of the Board.
2056. Name and address of Applicant M/s Mehran International, Pliva Avenue Hume Road
Near World Map, Karachi, Pakistan
Detail of Drug Sale License Address: Mehran International, Plot No. JM 25/1 S.T. Homes shop No.
4/4-A, Jamshed quarter, Karachi.
Manufacturer & Product M/s Shanxi PUDE Pharmaceutical Co., Ltd., First Pharmaceutical Zone,
License Holder Econmic & Development Zone of Datong, Shanxi, China (as per CoPP
and sole agency agreement) Exporting agent for Pakistan:
M/s Ninhua Group Co., Ltd., 21 Jiangxia St. Ningbo, P.R.
China (As per sole agency agreement)
Brand Name +Dosage Form + METHOTREXATE for IV injection 50mg/vial
Strength Freeze dried cake for solution for injection (Lyophilized
Powder)

Methotrexate…. 50mg
Pharmacological Group L04AX Other immunosuppressants
Pack size 1’s
International Availability USFDA Approved
Me-too status Methogen by Gene Tech Laboratories
Stability studies
Detail of certificates attached  Original legalized CoPP (certificate No. (20150006) issued by Shanxi
Food and Drug Administration valid till 31/08/2017 declaring the free
sale of applied product and GMP compliant status of the manufacturer.
Remarks of the Evaluator. Reason for Discontinuation cannot be confirmed. The formulation in other
reference countries is registered as solution for injection.
Firm has initially submitted real-time stability data conducted at 25 ± 2oc
and 65 ± 5%RH, letter was issued to submit stability study data conducted
according to the conditions of zone IV-A. In response to the letter firm
has submitted stability data sheet
specifying stability conditions as 30 ± 2oc and 65 ±
5%RH with same results at each time point.
Decision of 274th meeting of Registration Board: Registration Board deferred the cases for:
a. Submission of clarification regarding since the data/assay values in the stability
studies are unjustifiable/irrational as there is no difference in assay values of initially
submitted stability data (at 25 ± 2oc and 60 ± 5%RH) and the stability data submitted
after issuance of letter (at 30 ± 2oc and 65 ± 5%RH). Since this ambiguity shows that
the revised data (at 30 ± 2oc and 65 ± 5%RH) is not true
b. Detail of diluent to be used for reconstitution.
c. Evidence of approval of the product in reference regulatory authorities in the same
strength/volume/dosage form.
d. Original, legalized and valid CoPP
Evaluation by PEC:
a. The firm has submitted Real Time Stability data (24 months) and Accelarated stability data
(6months) of 3 batches (1845027 Mfg date:June5, 1845028 Mfg date: June 6, 2017, 1845029 Mfg
date:June 07 2017). However, the firm has not submitted any reply/clarification regarding
previously submitted stability data of the same product.
b. Detail of diluent used for reconstitutions are 5% dextrose or 0.9% NaCL.
c. The product approved in USFDA with same strength and dosage form that is 50mg Powder For
injection is discontinued and reason for discontinuation is not mentioned on the official website of
the authority while 50mg/2ml solution for injection is approved in USFDA. However, another
higher strength is approved in USFDA, Methotrexate For Injection by M/s Fresenius Kabi USA
(Each vial contains Methotrexate as sodium......1000mg with no preservative). Moreover, USP
monograph for Methotrexate For Injection is also available.
d. Original legalized CoPP (certificate No. (2018002) issued by Shanxi Food and Drug Administration
valid till 26/02/2020 declaring the free sale of applied product and GMP compliant status of the
manufacturer.
Decision of 295th meeting: Registration Board deferred the case and decided that Secretary Registration
Board will confirm from manufacturer M/s Shanxi PUDE Pharmaceutical Co., Ltd (Marketing
Authorization Holder) via e-mail regarding authenticity of the latest submitted stability data.
Decision: Approved as per Policy for inspection of Manufacturer abroad. Stability data will be
verified by panel during inspection of the firm.

and sole agency agreement) Exporting agent for Pakistan:
M/s Ninhua Group Co., Ltd., 21 Jiangxia St. Ningbo, P.R.
China (As per sole agency agreement)
Strength Freeze dried cake for solution for injection (Lyophilized Powder)
Pack size 1’s
International Availability USFDA Approved
Stability studies
has submitted stability data sheet
specifying stability conditions as 30 ± 2oc and 65 ±
5%RH with same results at each time point.
th
Decision of 274 meeting of Registration Board: Registration Board deferred the cases for:
Evaluation by PEC:
(6months) of 3 batches (19456620 Mfg date:July 09, 19456621 Mfg date: July 10, 2017, 19456622
Mfg date: July 11, 2017). However, the firm has not submitted any reply/clarification regarding
c. The product approved in USFDA with same strength and dosage form that is 100mg For injection
is discontinued and reason for discontinuation is not mentioned on the official website of the
authority while 100mg/4ml solution for injection is available in USFDA. However, another higher
strength is approved in USFDA, Methotrexate For Injection by M/s Fresenius Kabi USA (Each vial
contains Methotrexate as sodium......1000mg with no preservative). Moreover, USP monograph for
Methotrexate For Injection is also available.

manufacturer.
and sole agency agreement)
Exporting agent for Pakistan:
M/s Ninhua Group Co., Ltd., 21 Jiangxia St. Ningbo, P.R. China (As per
sole agency agreement)
Strength Freeze dried cake for solution for injection (Lyophilized
Powder)
Pack size 1’s
International Availability
Stability studies
has submitted stability data sheet specifying stability conditions as 30 ±
2oc and 65 ± 5%RH with same results at each time point.
Evaluation by PEC:

(6months) of 3 batches (2010100 Mfg date: Aug 15, 2010101 Mfg date: Aug16, 2017, 2010102
Mfg date: Aug 18, 2017). However, the firm has not submitted any reply/clarification regarding
c. The product (500mg for injection) with same strength and dosage form is not available in reference
authorities while 500mg/20ml solution for injection is discontinued for reasons other than safety
and efficacy. However, another higher strength is approved in USFDA, Methotrexate For Injection
by M/s Fresenius Kabi USA (Each vial contains Methotrexate as sodium......1000mg with no
preservative). Moreover, USP monograph for Methotrexate For Injection is also available.
manufacturer.
Manufacturer & Product M/s Shanxi PUDE Pharmaceutical Co., Ltd., First
License Holder Pharmaceutical zone , Economic & Technological and
Developlment Zone, Datong, Shanxi
Brand Name +Dosage Form + VINORELBINE Injection 10mg
Strength Lyophilized powder for injection
Vinorelbine Tartrate Eq. to Vinorelbine….. 10mg
Finished Product Specification USP (Monograph is present for sterile solution)
Shelf life 2 Years
Pack size 1’s
Me-too status
Stability studies
Detail of certificates attached  Original legalized CoPP (certificate No. 20150010) issued by Shan Xi
Remarks of the Evaluator.  The firm has applied the registration application with generic name.
 The firm has claimed USP specifications and the product is not
present in USP/BP.
 The product in reference countries is registered as solution for
injection while the applied formulation is in the form of lyophilized
powder for injection. Moreover, the Vinorelbine tartrate Equivalent to
10mg/ml base is registered in reference countries while the applied
product is Vinorelbine bitartrate 10mg/vial.
th

d. The salt form of the drug as it is different from the approved product in reference countries.
e. Finished product specifications.
Evaluation by PEC:
a. Detail of diluent used for reconstitutions are 5% dextrose or 0.9% NaCL.
b. Reference formulation is NAVELBINE® 10 mg/ml concentrate for solution for infusion (UK)
while applied is VINORELBINE Injection 10mg Lyophilized powder for injection.
c. Legalized CoPP (certificate No. 2018006) issued by Shan Xi Food and Drug Administration valid
till 26/02/2020 declaring the free sale of applied product and GMP compliant status of the
manufacturer and showing Correct salt form is submitted.
d. Firm submitted CFDA standard specification.
e. The firm has submitted 24 months Real time stability and 06 months Accelerated stability data of
3 batches (21000401 Mfg date: Sep 15, 2017, 21000402 Mfg date: Sep 16, 2017, 21000403 Mfg
Date: Sep 17, 2017). However the firm has not submitted the reply/clarification regarding
previously submitted stability data.
f. Salt form
Decision: Approved with innovator’s specifications as per Policy for inspection of Manufacturer
abroad. Stability data will be verified by panel during inspection of the firm.
Manufacturer & Product M/s Shanxi PUDE Pharmaceutical Co., Ltd., First
License Holder Pharmaceutical zone , Economic & Technological and
Developlment Zone, Datong, Shanxi
Brand Name +Dosage Form + VINORELBINE Injection 50mg
Strength Lyophilized powder for injection
Vinorelbine Tartrate Eq. to Vinorelbine….. 50mg
(Monograph is present for sterile solution)
Shelf life 2 Years
Pack size 1’s
Me-too status
Stability studies
Detail of certificates attached  Original legalized CoPP (certificate No. 20150010) issued by Shan Xi

Remarks of the Evaluator.  The firm has applied the registration application with generic name.
 The firm has claimed USP specifications and the product is not
present in USP/BP.
 The product in reference countries is registered as solution for
injection while the applied formulation is in the form of lyophilized
powder for injection. Moreover, the Vinorelbine tartrate Equivalent to
50mg/5ml base is registered in reference countries while the applied
product is Vinorelbine bitartrate 50mg/vial.
th
d. The salt form of the drug as it is different from the approved product in reference countries.
e. Finished product specifications.
f. Sole agency agreement
Evaluation by PEC:
a. Detail of diluent used for reconstitutions are 5% dextrose or 0.9% NaCL.
b. Reference formulation is NAVELBINE® 10 mg/ml concentrate for solution for infusion (UK)
while applied is VINORELBINE Injection 10mg Lyophilized powder for injection.
c. Legalized CoPP (certificate No. 2018006) issued by Shan Xi Food and Drug Administration valid
till 26/02/2020 declaring the free sale of applied product and GMP compliant status of the
manufacturer and showing Correct salt form is submitted.
d. Firm submitted CFDA standard specification.
e. The firm has submitted 24 months Real time stability and 06 months Accelerated stability data of
3 batches (21000404 Mfg date: Sep 18, 2017, 21000405 Mfg date: Sep 19, 2017, 21000406 Mfg
Date: Sep 19, 2017). However the firm has not submitted the reply/clarification regarding
previously submitted stability data.
f. Salt form
Decision: Approved with innovators specifications as per Policy for inspection of Manufacturer
abroad. Stability data will be verified by panel during inspection of the firm.
Registration Board in 295th meeting had decided to defer the below mentioned 02 cases and decided Secretary
Registration Board will confirm from the manufacturer via email regarding the authenticity of submitted stability
data. Accordingly, the Secretary Registration Board communicated with the firm regarding the submitted stability
data of relevant batches.
The reply received from the relevant firm is being reproduced hereby before the Board.
Dear ABDULLAH
Sorry for my late reply.
we (Cisen Pharmaceutical Co. Ltd.) confirm that the stability data of IRINOTECAN INJECTION
40mg/2mL and IRINOTECAN INJECTION 100mg/5mL with the following information was submitted by our
company.
Sr. Brand Name & Composition Stability Batch No. Manufacturing Date
1. IRINOTECAN injection 40mg: 19277800 Oct 20, 2017
Each ampoule (2mL) contains: 19277801 Oct 21, 2017
Irinotecan hydrochloride 19277802 Oct 22, 2017
trihydrate……40mg
2. IRINOTECAN injection 100mg: 19277803 Oct 23, 2017
19277804 Oct 24, 2017

Each ampoule (5mL) contains: 19277805 Oct 25, 2017
Irinotecan hydrochloride
trihydrate……100mg
Please see attachment for STATEMENT.
Best regards!
Anna
Cisen Pharmaceutical Co., Ltd.
Add: Tongji Sci-tech Industrial Park, High-tech Industrial Development Zone, Jining, Shandong, P.R. China.
272073
Tel: +86 537 2980071 +86-18678761518
------------------ Original ------------------
From: "wangsh"<wangsh@cisengroup.com>;
Date: Sat, Aug 29, 2020 04:52 PM
To: "Abdullah Abro"<abroabdullah@gmail.com>;
Cc: "selina"<selina@nbpharm.com>; "shirlyran"<shirlyran@nbpharm.com>; "Obaidullah
Malik"<obaiddr@yahoo.com>;
Subject: Re:Confirmation of Authenticity of Stability Data
Manufacturer & Product M/s Cisen Pharmaceutical Co. Ltd., Tongji Tech-Industry
License Holder Garden, Jining High & New Technology Ind. Development Zone,
Jining, Shandong Province, China.

M/s Ninhua Group Co., Ltd., 21 Jiangxia St. Ningbo, P.R.China
Brand Name +Dosage Form + IRINOTECAN injection 40mg
Strength
Composition Each ampoule (2ml) contains:
Irinotecan…… 40mg
Finished Product Specification (USP)
Shelf life 3 Years
Pack size 1’s
International Availability Each vial with 2 ml contains 40 mg Irinotecan hydrochloride trihydrate
(UK)
Me-too status Irinotecan Ebewe by Novartis Pharma Pakistan (Reg #066186)
Stability studies
Detail of certificates attached Original legalized CoPP (certificate No. 151100B0/62246) issued by
Jining Food and Drug Administration valid till 14/12/2017 declaring the
free sale of applied product and GMP compliant status of the
manufacturer.
Remarks of the Evaluator. The firm has claimed In House manufacturing
specifications and the product is present in USP.
The product is not available in reference countries as Powder for Solution
but it is available as Solution for injection.
according to the conditions of zone IV-A. In response to the letter firm has
submitted stability data sheet specifying stability conditions as 30 ± 2oc
and 65 ± 5%RH with same results at each time point
Submission of clarification regarding since the data/assay values in the stability
Detail of diluent to be used for reconstitution.
Evidence of approval of the product in reference regulatory authorities in the same
Now the firm has submitted:
In response to decision of Registration Board the firm has submitted (dated 15th August 2017, and after
that on dated 13th December 2019 of three batches is submitted. Different years but same batch no.,
assay and other parameters as well.
Reference formulation is Each vial with 2 ml contains 40 mg Irinotecan hydrochloride trihydrate (UK)
while applied is Each ampoule (2ml) contains: Irinotecan…… 40mg
CoPP valid till 14-12-2017
Copy of valid DSL
Composition different from reference?
Evaluation by PEC:
The composition of the product as presented in 274th meeting is not correct, the correct composition of the
product is given in the following confirmed from the original dossier.
Each 2ml Ampoule contains:
Irinotecan hydrochloride trihydrate……20mg (equivalent to Irinotecan……17.33mg)

Approval status of the product in reference regulatory authorities is confirmed.
CAMPTO 20 mg/ml concentrate for solution for infusion (2ml Vial, 5ml Vial, 15ml Vila) by M/s Pfizer
limited, MHRA Approved.
The firm has submitted 24 months Real time stability and 06 months Accelerated stability data of 3 batches
(19277800 Mfg date: Oct 20, 2017, 19277801 Mfg date: Oct 21, 2017, 19277802 Mfg Date: Oct 22, 2017).
However the firm has not submitted the reply/clarification regarding previously submitted stability data.
COPP is not valid and was expired on 14/12/2017.
Manufacturer & Product M/s Cisen Pharmaceutical Co. Ltd., Tongji Tech-Industry
License Holder Garden, Jining High & New Technology Ind. Development Zone,
Jining, Shandong Province, China.
M/s Ninhua Group Co., Ltd., 21 Jiangxia St. Ningbo, P.R.China
Brand Name +Dosage Form + IRINOTECAN injection 100mg
Strength
Composition Each ampoule (5ml) contains:
Irinotecan…… 100mg
Finished Product Specification (USP)
Shelf life 3 Years
Pack size 1’s
International Availability Each vial with 5 ml contains 100 mg Irinotecan hydrochloride trihydrate
(UK)
Me-too status Irinotecan Ebewe by Novartis Pharma Pakistan (Reg #066187)
Stability studies
Detail of certificates attached Original legalized CoPP (certificate No. 151100B0/47074) issued by
Jining Food and Drug Administration valid till 16/09/2017 declaring the
free sale of applied product and GMP compliant status of the
manufacturer.
Remarks of the Evaluator. The firm has claimed In House manufacturing
specifications and the product is present in USP.
The product is not available in reference countries as Powder for Solution
but it is available as Solution for injection.
according to the conditions of zone IV-A. In response to the letter firm has
submitted stability data sheet specifying stability conditions as 30 ± 2oc
and 65 ± 5%RH with same results at each time point
th
Submission of clarification regarding since the data/assay values in the stability

Detail of diluent to be used for reconstitution.
Evidence of approval of the product in reference regulatory authorities in the same
Now the firm has submitted:
In response to decision of Registration Board the firm has submitted data dated 13 th December 2019 of
three batches is submitted. Different years but same batch no., assay and other parameters as well.
Reference formulation is Each vial with 5 ml contains 100 mg Irinotecan hydrochloride trihydrate
(UK) while applied is Each ampoule (5ml) contains: Irinotecan…… 100mg
CoPP valid till 16-09-2017
Evaluation by PEC:
The composition of the product as presented in 274th meeting is not correct, the correct composition of the
product is given in the following confirmed from the original dossier.
Each 2ml Ampoule contains:
Irinotecan hydrochloride trihydrate……20mg (equivalent to Irinotecan……17.33mg)
Approval status of the product in reference regulatory authorities is confirmed.
CAMPTO 20 mg/ml concentrate for solution for infusion (2ml Vial, 5ml Vial, 15ml Vila) by M/s Pfizer
limited, MHRA Approved.
The firm has submitted 24 months Real time stability and 06 months Accelerated stability data of 3 batches
(1977803 Mfg date: Oct 23, 2017, 19277804 Mfg date: Oct 24, 2017, 19277805 Mfg Date: Oct 25, 2017).
However the firm has not submitted the reply/clarification regarding previously submitted stability data.
COPP is not valid and was expired on 16/09/2017.
c. New cases (Import) Veterinary

2063. Name and address of Applicant M/s Geevet International First floor Naz Medicine Market Namak
Mandi Peshawer
Drug Sale License M/s Geevet International Naz Medicine Market Namak Mandi
Peshawar
Whole sale / distributor
Valid till 01/01/2022.
Name and address of Manufacturer and MAH:
manufacturer M/s Inner Mongolia Huatian Pharmaceutical Co., Ltd. Economic
Development & Experiment Zone for Economical transformation
of Resource dependent city, Chifeng, Inner Mongolia, PR. China
Brand Name +Dosage Form + Lincocid Gold soluble powder
Strength
Spectinomycin base…..444mg
Lincomycin base……..222mg
Finished Product Specification Chinese Pharmacopoeia
Pack size 1kg, 500gm, 250gm
Me-too status LINCO-S 100 W/S POWDER by M/s Attabak, Reg. No. 062169

Stability studies Firm has submitted long term (24 months) at 30oC 65% RH &
accelerated (06 months) stability data at 40oC, 75% RH for three
batches.
Detail of certificates attached Original Legalized CoPP (Certificate#. 05019) Certifying
Authority “veterinary Bureau of the Inner Mongolia autonomous
Region” declaring the free sale of applied product and GMP
compliant status of the manufacturer i.e., M/s Inner Mongolia
Huatian Pharmaceutical.
Valid until 02-07-2023
abroad.
2064. Name and address of Applicant M/s Qualivet Pharma, No.5/15, Ground Floor, Survey No.79,
Golden town, Karachi.
Detail of Drug Sale License Address: M/s Qualivet Pharma, H.No. 5/15 Groud floor, survey
no.79 golden town Karachi.
Validity: 26-11-2019
Status: License to sell, stock & exhibit for sale, distribute and sell
drugs by way of WHOLE SALE by manufacturer, importer or
intender.
Name and address of M/s Laboratory Karizoo SA, , Mas Pujades, 11-12, Pol. Ind. La
manufacturer Borda, caldes de Montbui, 08140, Barcelona, Spain.
Name and address of marketing M/s Vetpharm animal Health, S.L. Les Corts, 23 08028 Barcelona,
authorization holder Spain.
Name of exporting country Spain
Brand Name +Dosage Form + LEVOFLOK 100mb/ml Oral Solution
Strength
Enrofloxacin……..100mg
Pharmacological Group Abtibacterial
Shelf life 3 years
Pack size 250ml, 1Litre, 5Litre
International availability Available in Spain for free sale as per CoPP
Me-too status ROXIN 10% ORAL SOLUTION by M/s M&H
PHARMACEUTICALS LAHORE (Imported ) Reg. No. 015495
Detail of certificates attached Original Legalized CoPP:
Certificate No: Nil
Certifying Authority: Agencia Espanola De Medicomentos Y
productos Sanitarios, SPAIN
Issue Date: 10/05/2018
Free sale in exporting country: Yes
Applicant of certificate: Vetpharm animal Health, S.L. Les Corts,
23 08028 Barcelona, Spain.
GMP:
 Original legalized GMP Certificate
Certificate no. ES/135HV/19
Manufacturer Address: M/s Laboratory Karizoo SA, Mas
Pujades, 5-10, 11-12, Pol. Ind. La Borda, caldes de Montbui, 08140,
Barcelona, Spain.
Issued by: Agencia Espanola De Medicomentos Y productos
Sanitarios, SPAIN
Status: valid till 23/04/2022
abroad. Moreover the applicant will provide the valid copy of Drug sale License.
2065. Name and address of M/s Hassan Brothers House No. 318 St. # 6 Fatehabad Sharqi,
Applicant Satiana Road Faisalabad
Detail of Drug Sale License M/s Hassan Brothers Ground floor P. 318 St. # 6 Mohallah Fateh
abad Sharqi, Satiana Road Faisalabad License to sell drugs as a
distributor No: 0011000 0001570 valid upto *29-March-2020.
*The firm has submitted the receipt for renewal of DSL dated
24/06/2020.
Product License Holder & Head office:
Manufacturer M/s Samyang Anipharm co. 6-5, Tongil-ro 83-gil, Eunpyeong-gu,
seoul, Korea
Factory:
M/s Samyang Anipharm co. Ltd. 35, Songseon-ro 265 beon-gil,
Pocheon-si, Gyconggi-do, Korea
Brand Name +Dosage Form + FLOCOL-200 SOLUTION
Strength
Florfenicol….200mg
Finished Product Specification In house
Pack size & Demanded Price 500ml, 1L, 2.5L & 5L
International availability Korea
Me-too status TEMPRO-20% LIQUID by M/s Ras Pharma, Reg. No. 96838
Stability studies Real Time data for 24 months
Accelerated data for 6 months as per Zone-IVA submitted.
Detail of certificates attached  Original Legalized FSC (Certificate#. M1813617) issued on 02-
10-2018 by Animal and Plant Quarantine Agency Korea
declaring the free sale of applied product in country of origin
Korea.
 Original Legalized GMP issued by Animal and Plant Quarantine
Agency Korea dated 02-10-2018.
 Original sole agency agreement is submitted. M/s Samyang
Anipharm co. 6-5, Tongil-ro 83-gil, Eunpyeong-gu, seoul,
Korea appointed M/s Hasssan Brothers Faisalabad as
Distributor for Pakistan for the applied product.
Decision: Approved as per policy for inspection of manufacturer abroad.
2066. Name and address of Applicant M/s Vety care (pvt) ltd. 4-A, block A Satelite town
Rawalpindi.
Detail of Drug Sale License Drug License by way of
Manufacturer & Product License Manufacturer:
Holder Intervet GesmbH, Siemensstrasse 107, 1210, Vienna, Austria.
Marketing Authorization Holder:
M/s Intervet International B.V., Wim de Korverstraat 35, 5831 An
Boxmeer, the Netherlands.
Name of exporting country The Netherlands
Brand Name +Dosage Form + Bravecto 1000mg Chewable tablets for dogs
Strength
Composition Each Chewable table contains:
Fluralaner………1000mg
Pharmacological Group Ectoparasiticides
Pack size & Demanded Price Price decontrolled
Stability studies
Detail of certificates attached Copy of certificate of a veterinary medicinal product
certificate no. 05/17/110419 issued by EMA on 28/06/2017,
the applied product is in the market of exporting region. The
facilities and operation conform to WHO-GMP.
Remarks of the Evaluator. The submitted stability data contains the results of only initial
time point. Submit 06 months accelerated stability and 24
months real time stability study data according to the conditions
of zone IV-A.
Product specific sole agency agreement is required to be
submitted.
Submit original legalized and valid CoPP/medicinal product
certificate.
Give detail of pack size of the applied product.
Decision: Deferred for submission of the following;
 Submission of 06 months accelerated stability and 24 months real time stability study data of
03 batches according to the conditions of zone IV-A.
 Product specific sole agency agreement is required to be submitted.
 Submission of original legalized and valid CoPP/medicinal product certificate.
 Detail of pack size of the applied product.
Rawalpindi.
Brand Name +Dosage Form + Bravecto 112.5mg Chewable tablets for dogs
Strength
Fluralaner………112.5mg
Stability studies

(112.5mg, 250mg, 500mg, 1000mg, 1400mg) certificate no.
05/17/110419 issued by EMA on 28/06/2017, the applied
product is in the market of exporting region. The facilities and
operation conform to WHO-GMP.
Remarks of the Evaluator. Submit real time stability data till shelf life and 06 month
accelerated stability data of 03 batches according to the
conditions of zone IV-A.
submitted.
certificate.
Rawalpindi.
Strength
Stability studies
submitted.
certificate.
Rawalpindi.
Strength
Stability studies
submitted.
certificate.
Me-too status of the product
2070. Name and address of Applicant M/s Meezab Z International Company, Fareed Abad near
Bilal Mosque, Jahanian, Punjab.
Manufacturer & Product License Manufacturer & MAH:
Holder Al Reef company for manufacturing Veterinary Drugs &
Agrichemicals (REEFCO), Alhassan Industrial Estate, Irbid,
Jordan.
Name of exporting country Jordan

Brand Name +Dosage Form + Reefmox oral powder 50%
Strength
Amoxicillin trihydrate…… 500mg
Me-too status
Stability studies 36 months real time and 06 months accelerated stability study
data of 03 batches is submitted. (HDPE jar).
Detail of certificates attached Original legalized Free Sale Certificate issued by Ministry of
Agriculture , Veterinary Directorate, Jordan on 04/01/2017
certificate no. 00079. The product is registered and freely sold
in exporting country as per the certificate.
Original legalized GMP certificate issued by Director of
Veterinary & Animal Health on 09/12/2018.
Remarks of the Evaluator. Provide product specific sole agency agreement.
Clarification is required since the Qc testing of the applied
product is done according to the In-House standard while the
product is present in British Pharmacopoeia (B.P). Moreover,
the assay is performed for Amoxicillin Trihydtrate while the
content of Amoxicillin (base) should be determined considering
the prescribed assay limits according to B.P, clarify.
Provide evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along with
Clarification regarding the pack size is required.
Provide valid copy of Drug Sale license.
Decsion: Deferred for the following:
 Provide product specific sole agency agreement.
 Clarification is required since the Qc testing of the applied product is done according to the
In-House standard while the product is present in British Pharmacopoeia (B.P). Moreover,
the assay is performed for Amoxicillin Trihydtrate while the content of Amoxicillin (base)
should be determined considering the prescribed assay limits according to B.P, clarify.
 Provide evidence of applied formulation/drug already approved by DRAP (generic / me-
 Clarification regarding the pack size is required.
 Provide valid copy of Drug Sale license.
Jordan.
Brand Name +Dosage Form + Neoreef 500 oral powder
Strength
Neomycin sulphate…… 500mg

Me-too status
Submit drug product specification data in the light of decision
of Registration Board in its 267th meeting.
Decision: Deferred for the following;
 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
Jordan.
Brand Name +Dosage Form + Reedox 500 oral powder
Strength
Doxycycline HCl…… 500mg
Me-too status

267th meeting.
2073. Name and address of Applicant M/s Cherry Pharmceutica International, 14-E, Ground
floor/basement, Punjab cooperative housing society, Ghazi
road Lahore.
Address: Cherry Pharmceutica International, 14-E, Ground
road Lahore.
Holder Mevet S.A.U. Poligono Industrial El Segre, no 409-410 y CP 25191
LLEIDA, Spain
Exporter:
MPA Vetrinary Medicines and Additives S.L. C/Mogoda, 16-18
Pol. Ind. Can Salvatella. Barbera del Valles. Barcelona, Spain.
Brand Name +Dosage Form + Linesvall 150mg/ml solution for injection
Strength
Lincomycin as hydrochloride……………….50mg
Spectinomycin as sulphate tetrahydrate…….100mg
Shelf life 3 years
Pack size & Demanded Price 100ml vial, Price decontrolled
Me-too status BIO-LINCO-S INJECTION. 200/50mg per ml by M/s
International chempharma Reg. No. 39967
Stability studies 36 months data according to the conditions of zone IV-A of 3
batches is submitted.
Accelerated data is not submitted.
Detail of certificates attached Legalized Free sale certificate issued by Agencia espanola de
medicamentos y productos sanitorios (AEMPS) issued on
08/06/2018 confirms the free sale of the product in exporting
country.
Copy of GMP certificate no. ES/123HV/18 issued by
AEMPS, inspection date 12/07/2018.
Original Legalized Agency Agreement is submitted. The
Principal (Manufacture and Exporter) authorized M/s Cherry
Pharmaceutica International as distributor (exclusive agent)
for Pakistan.
abroad.
2074. Name and address of Applicant M/s Cherry Pharmceutica International, 14-E, Ground
road Lahore.
Address: Cherry Pharmceutica International, 14-E, Ground
road Lahore.
Holder Mevet S.A.U. Poligono Industrial El Segre, no 409-410 y CP 25191
LLEIDA, Spain
Brand Name +Dosage Form + Tilovall 200mg/ml solution for injection
Strength
Tylosin…….200mg
Shelf life 2 years
Pack size & Demanded Price Price decontrolled, 100ml vial
Me-too status BILOSIN 200MG/ML SOLUTION FOR INJECTION by
M/s Binsadiq International, Reg. no. 84841
Stability studies 24 months real time, 06 months accelerated stability
Detail of certificates attached Legalized Free sale certificate for Tilovall 200mg/ml issued
by Agencia espanola de medicamentos y productos
sanitorios (AEMPS) issued on 08/06/2018 confirms the free
sale of the product in exporting country.
Copy of GMP certificate no. ES/123HV/18 issued by
AEMPS, inspection date 12/07/2018.
Original Legalized Agency Agreement is submitted. The
Principal (Manufacture and Exporter) authorized M/s Cherry
Pharmaceutica International as distributor (exclusive agent)
for Pakistan.
2075. Name and address of Applicant M/s ZS Biotech Animal Health Company. 50-C Madina
Block Awan Town Multan Road, Lahore.
Address:
Validity:
Holder Farmabse Saude Animal Ltda Av. Emilio Marconato, n o 1000-
Galpao A-Jaguariuna (SP) Brazil.
Name of exporting country brazil

Brand Name +Dosage Form + Farmadox 50 oral powder
Strength
Doxycycline hyclate……. 50gm
Pharmacological Group tetracycline
Shelf life 2 years
Pack size & Demanded Price 200gm & 25kg, price decontrolled
Me-too status
Stability studies
Detail of certificates attached
Remarks of the Evaluator. Original and legalized free sale certificate is submitted while
legalized free sale with English translation is required.
As per submitted SmPC, the applied formulation contains
“Doxycycline As Hyclate” while according to the free sale
certificate and form 5A, the product contains “Doxycycline
Hyclate”, clarify.
Submit 06 months accelerated stability studies of 03 batches.
Valid copy of Drug Sale License is required.
 Original and legalized free sale certificate is submitted while legalized free sale with English
translation is required.
 As per submitted SmPC, the applied formulation contains “Doxycycline As Hyclate” while
according to the free sale certificate and form 5A, the product contains “Doxycycline Hyclate”,
clarify.
 Submit 06 months accelerated stability studies of 03 batches.
 Valid copy of Drug Sale License is required.
2076. Name and address of Applicant M/s Orient Animal Health (pvt) ltd. Commercial #6, Block-
A, 1st floor, Kazimabad, Near Masjid e Hira, Model Colony,
Karachi.
Detail of Drug Sale License Drug License by way of wholesale
Address: Orient Animal Health (PVT) LTD. Comm-6
Block-A Ist floor Kazimabad, Model Colony Karachi.
Godwon: Ground floor C-14 Block-A Kazimabad Model
Colony Karachi.
Holder M/s Univet Ltd., Tullyvin, Cootehill, County Cavan, H16
T183 , Ireland.
Brand Name +Dosage Form + Solu-Flox 100mg/ml solution for use in drinking water
Strength
Enrofloxacin……… 100mg
Pharmacological Group Anti bacterial
Shelf life 3 years
Pack size & Demanded Price 100ml, 1 litre, 5 litre, price decontrolled
Me-too status ENROFLOX SOLUTION (10gm/100ml) by M/s Biorex,
Reg. No. 031528
Stability studies
Detail of certificates attached
Remarks of the Evaluator. Submit original, legalized and valid CoPP/free sale certificate
and valid copy of GMP certificate.
Stability study data of 36 months real time and 06 months
accelerated of 03 batches according to the conditions of zone
IV-A.
The applied product is Oral Solution to be used with drinking
water while the product is present in USP as Oral Suspension,
clarify.
Decision: Deferred for the following:
 Submit original, legalized and valid CoPP/free sale certificate and valid copy of GMP certificate.
 Stability study data of 36 months real time and 06 months accelerated of 03 batches according
to the conditions of zone IV-A.
267th meeting.
 The applied product is Oral Solution to be used with drinking water while the product is
present in USP as Oral Suspension, clarify.
2077. 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.
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
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.

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.
267th meeting.
d. Case no. 4: Deferred cases (Import) Veterinary

2078. M/s Saadat International 117 Habitat Flat Shadman II
Name and address of Applicant
Jail Road Lahore
Biovet Joint Stock Company
39, Petar Rakov St. 4500 Peshtera, Bulgaria
Name and address of
(QC and Batch Release)
manufacturer
48 Vasil Petleshkov Str Peshtera 4550,Bulgaria
(Manufacturer)
Name and address of Product Huvepharma AD, 3a Nikolay Haytov street, 1113 Sofia
License Holder Bulgaria
Exporting Country Bulgaria
Brand Name +Dosage Form + Vetmulin 450mg/g
Strength Water soluble granules
Dy No. 336 : 09-06-2015
PKR 100,000/- : 09-06-2015
Each gram contains
Composition
Tiamulin hydrogen fumarate …………………450 mg
Target Specie Chicken, Turkey
ATC Vet Code: QJ01XQ01
Antibacterials for systemic use, Pleuromutilins
Finished Product Specification Innovator
Shelf life 2 years (supported by accelerated and real time stability data)
Pack size & Demanded Price 1 kg sachet
Approval status of product in Vetmulin (Denmark Approved)
Reference Regulatory Authorities. HPRA Approved
Me-too status 006846 TIAMUTIN 45% HILTON KARACHI
Original, legalized certificate of origin and free sale issued
on 20-03-2014 by Ministry of Agriculture and Food,
Bulgarian Food Safety Agency confirms its free sale
Copy of GMP certificate (No. 31/2013/GMP) issued on 27-
12-2013 by Ministry of Agriculture and Food, Bulgarian Food
Safety Agency confirms the GMP of Biovet but the address
written on certificate is different from that provided in Form 5-
CoPP/GMP status
A as well as in free sale certificate.
Authority letter M/s Saadat International 117 Habitat Flat
Shadman II Jail Road Lahore & Biovet Joint Stock Company
Dated : 13 June 2017 Biovet Joint Stock Company is subsidiary
of Huvepharma Eood Located in 3 A ,Nikolay haytov Street,
Sofia, 1113 , Bulgaria
Withdrawal Period:
Chickens
Meat and offal: 3 days
Eggs: Zero days
Turkeys
Meat and offal: 5 days
● The address of manufacturing site on GMP certificate
is “39, Petar Rakov St. 48 Vasil Petleshkov Str
Peshtera 4, Pazardjik, Bulgaria” which is different
from that provided on Form 5-A .
● The free sale certificate mentions the product license
holder is Biovet Joint Stock Company whereas Form
5 A mentions Huvepharma AD.
● Clarify 1 Kg sachet or bag.
● Clarification for type of container whether you have
applied for sachet or bag.
● The address of manufacturing site mentioned on Form
Previous Decision 5A is different from the address mentioned on GMP
(M-282) certificate. Clarification is required with documented
evidence.
● The product license holder mentioned on free sale
certificate is different from the product license holder
mentioned on Form 5A. Clarification is required.
Fresh Evaluation:
a. Clarification for type of container whether you have applied for sachet or bag.
1 Kg sachet
b. The address of manufacturing site mentioned on Form 5A is different from the address mentioned on
GMP certificate. Clarification is required with documented evidence.
(QC and Batch Release+Headquarter)
Biovet Joint Stock Company 39, Petar Rakov St. 4500 Peshtera, Bulgaria
(Manufactures)
c. The product license holder mentioned on free sale certificate is different from the
product license holder mentioned on Form 5A. Clarification is required.
Firm has submitted that product license holder is Biovet Joint Stock Company 39, Petar Rakov St.
4550 Peshtera, Bulgaria and the same has been mentioned on Free sale certificate.
“Deferred for above clarifications”
Now the firm has submitted the following documents:
a. Vetmulin 450mg/g
It is a 1kg sachet.
b. Original Legalized CoPP (Certificate#. BG 6/2019) issued on 29-01-2019 by Bulgarian Food Safety
Agency Ministry of Agriculture, Food and Forestry 15 Pencho Slaveikov Blvd. Sofia 1606, Bulgaria
declaring the free sale of applied product and GMP compliant status of the manufacturer i.e.,
BIOVET Joint Stock Company, 39 Petar Rakov Str. /48 Vasil Petleshkov Str., Peshtera 4550,
Bulgaria. Product License Holder of applied product is M/s Huvepharma NV, Uitbreidingstraat
80, 2600 Antwerpen, Belgium.
(Revised form-5A showed that Address of QC, Batch release and Headquarter: 39, Petar Rakov
Street, 4550 Peshtera, Bulgaria while address of manufacturing site is 48 vasil Petleshkov street,
Peshtera 4550, Bulgaria)
c. The firm has submitted original and legalized letter of authorization for the following products;
Hydrodoxx 500mg
Vetmulin 450mg
Tilmovet 250mg
Decision: Deferred for confirmation whether the applicant has applied same addresses of
manufacturing sites as per CoPP.
2079. M/s Saadat International 117 Habitat Flat Shadman II Jail
Name and address of Applicant
Road Lahore

Name and address of
manufacturer
(Manufactures)
Name and address of Product Huvepharma AD, 3a Nikolay Haytov street, 1113 Sofia
License Holder Bulgaria
Brand Name +Dosage Form +
Tilmovet 250mg/ml Concentrate for oral solution
Strength
Dy No. 337 : 09-06-2015
PKR 100,000/- : 09-06-2015
Each ml contains
Composition
Tilmicosin …………………250 mg
Target Specie Chicken (Broiler, pullets), Turkey and Calves
Antimicrobials for systemic use, macrolides
ATC vet code: QJ01FA91
Shelf life 2 years
Firm has submitted long term (24 months) at 30±2oC RH 65%+ 5%+
Stability studies 5% & accelerated (06 months) stability data at 40+ 2oC, 75+ 5% RH
for three batches.
960 ml is presented in a white high density polyethylene
bottle with white polypropylene or , tamper-evident cap, 240
Pack size & Demanded Price ml is presented in high density polyethylene (HDPE) bottle
with a closure made of PET.
60 mL PET vials with closure of PET/PE
Approval status of product in
HPRA Approved
044909 HICOS 250 ORAL SOLUTION
Me-too status
HILTON PHARMA (PVT) LTD., KARACHI.
Bulgarian Food Safety Agency confirms its free sale
CoPP/GMP status
written on certificate is different from that provided in Form
5-A as well as in free sale certificate
Withdrawal Period:
Calves: 42 days.
Chickens: 12 days
Turkeys: 19 days
Eggs: Not authorized for use in birds producing eggs for
human consumption.
Remarks of the Evaluator. ● The address of manufacturing site on GMP certificate
is 39, Petar Rakov St. 48 Vasil Petleshkov Str
Peshtera 4, Pazardjik, Bulgaria which is different
from that provided on Form 5-A .
holder is Biovet Joint Stock Company whereas Form
5 A mentions Huvepharma AD.
Previous Decision ● Clarification for type of container whether you have
(M-282) applied for sachet or bag.

5A is different from the address mentioned on GMP
certificate. Clarification is required with documented
evidence.
Fresh Evaluation:
960 ml is presented in a white high density polyethylene bottle with white polypropylene or , tamper
evident cap, 240 ml is presented in high density polyethylene (HDPE) bottle with a closure made of
PET.60 mL PET vials with closure of PET/PE.
b. The address of manufacturing site mentioned on Form 5A is different from the address
mentioned on GMP certificate. Clarification is required with documented evidence.
(Manufactures)
4550 Peshtera, Bulgaria and the same has been mentioned on Free sale certificate.
“Deferred for above clarifications”

a. Tilmovet 250mg/ml concentrate for oral solution is packed in 3 container types and sizes:
High density polyethylene (HDPE) bottles of 960ml with vertically see-through bar and a
graduated scale provided with white tamper evident closure made of PP with white foamed
sealing disk.
High-density polyethylene (HDPE) bottles of 240ml with a closure made of polyethylene
terephthalate (PET).
Polyethylene terephthalate (PET) vials of 60ml with a closure made of polyethylene
terephthalate/polyethylene (PET/PE).
(Provided stability data is of only 240ml bottle)
b. Original Legalized CoPP (Certificate#. BG 7/2019) issued on 29-01-2019 by Bulgarian Food Safety
Agency Ministry of Agriculture, Food and Forestry 15 Pencho Slaveikov Blvd. Sofia 1606, Bulgaria
Hydrodoxx 500mg
Vetmulin 450mg
Tilmovet 250mg
2080. M/s Saadat International, 117 Habitat Flat Shadman II
Name address of Applicant
Jail Road Lahore
Address: 117 Habitat Flat Shadman II Jail Road Lahore
Lahore
Drug Sale License
Validity: 12-06-2020
Status: License to sell drugs as a Distributor
Name and address of manufacturer
48 Vasil Petleshkov Str Peshtera 4550,Bulgaria (Manufacturer)
Name and address of Product Huvepharma
License Holder AD, 3a Nikolay Haytov street, 1113 Sofia Bulgaria
Brand Name +Dosage Form + HydroDoxx 500mg/g
Strength Powder for use in drinking water
Dy No. 335 : 09-06-2015
PKR 100,000/- : 09-06-2015
Each gram contains
Composition
Doxycycline (as hyclate) ……………………500 mg
ATC Vet Code:
Pharmacological Group QJ01AA02.: Antibacterial for systemic use; tetracyclines
Tetracycline
Target Specie Chicken Broiler
3 years (supported by accelerated and real time stability data)
Shelf life Shelf-life of the veterinary medicinal product as packaged for
sale: 36 months(HPRA)
Pack size & Demanded Price 1kg sachet
Approval status of product in Ireland Approved
Reference Regulatory Authorities. HPRA
023470
Me-too status Doxyveto- 50 S Soluble Powder
Vmd Pakistan Rawalpindi
Bulgarian Food Safety Agency confirms its free sale.
written on certificate is different from that provided in Form
5-A as well as in free sale certificate.
Authority letter
CoPP/GMP status
M/s Saadat International 117 Habitat Flat Shadman II Jail
Road Lahore
&
Dated : 13 June 2017
Biovet Joint Stock Company is subsidiary of Huvepharma
Eood Located in 3 A ,Nikolay haytov Street, Sofia, 1113 ,
Bulgaria
Withdrawal Period:
Meat and offal: Chicken : 6 days
Not authorized for use in laying birds producing eggs for
human consumption
Do not use within 4 weeks of onset of the laying period.
● The address of manufacturing site on GMP certificate
Remarks of the Evaluator. is 39, Petar Rakov St. 48 Vasil Petleshkov Str Peshtera
4, Pazardjik, Bulgaria which is different from that
provided on Form 5-A .
holder is Biovet Joint Stock Company whereas Form 5
A mentions Huvepharma AD.
● Clarify 1 Kg sachet or bag

● Clarification for type of container whether you have
applied for sachet or bag.
5A is different from the address mentioned on GMP
(M-282)
certificate. Clarification is required with documented
evidence.
Fresh Evaluation:
1 Kg sachet
b. The address of manufacturing site mentioned on Form 5A is different from the address
mentioned on GMP certificate. Clarification is required with documented evidence.
(Manufactures)
4550 Peshtera, Bulgaria and the same has been mentioned on Free sale Certificate.
Decision of 285th meeting of RB: Deferred for above clarifications

a. It is a 1kg sachet
b. Original Legalized CoPP (Certificate#. BG 5/2019) issued on 29-01-2019 by Bulgarian Food
Safety Agency Ministry of Agriculture, Food and Forestry 15 Pencho Slaveikov Blvd. Sofia 1606, Bulgaria
Hydrodoxx 500mg
Vetmulin 450mg
Tilmovet 250mg
2081. Name and address of M/s Poul Med Enterprises 9-C, Amber Estate Building, Balouch colony,
Applicant main shahrah-e-Faisal, Karachi Pakistan
Name and address of S.P. VETERINARIA, S.A. Crta. Reus-Vinyols, Km. 4.1 P.O. Box 60
manufacturer 43330 Riudoms (Tarrangona) Spain
Marketing authorization S.P. VETERINARIA, S.A. Crta. Reus-Vinyols, Km. 4.1 P.O. Box 60
holder 43330 Riudoms (Tarrangona) Spain
Brand Name +Dosage Form + COLMYC 20%
Strength Oral solution for administration in drinking water
Enrofloxacin……….200mg

Finished Product USP
Specification
Shelf life 3 years store below 300C
Pack size 500ml, 1L,5L
Me-too status EL-FLOXACIN LIQUID of M/s ELKO ORGANISATION,
Stability studies Firm has submitted long term (36 months) at 30oC 75±5%RH &
accelerated (06 months) stability data at 40oC, 75±5% RH for three
batches.
Detail of certificates attached Original Legalized CoPP dated 14th May 2018 by ministry of health,
social services and equality (Department of veterinary medicines)
declaring the free sale of applied product and GMP compliant status of
the manufacturer i.e., S.P. VETERINARIA, S.A. Crta. Reus-Vinyols,
Km. 4.1 P.O. Box 60 43330 Riudoms (Tarrangona) Spain
Remarks of the Evaluator. Applied product is Suspension as per USP monograph but applied
product is solution dosage form.
Decision of 292nd meeting of Registration Board:
Deferred for following: Applied product is suspension as per USP monograph, but applicant apply solution
dosage form.
M/s Poul Med submitted that the European Pharmacopoeia monograph number 2229 for Enrofloxacin
(Enrofloxacin for veterinary use) is the only monograph available for Enrofloxacin in the European
Pharmacopoeia. It describes the tests and specifications that the raw material (enrofloxacin) must follow
to comply with the European Pharmacopoeia standards. It does not state that it is for suspension product
forms only.
Decision of 293rd meeting: Registration Board deferred the application for dosage form clarification.
Submission by the firm: The firm has submitted that the dosage form of the applied product is Oral
Solution while in USP describes the monograph for Oral Suspension. The firm has requested for grant of
registration with innovator’s specifications. Moreover, the firm has submitted fee Rs. 5,000/- with the
reply (challan number 0539489 dated 22/04/2020).
Decision: Deferred for confirmation of composition of formulation in the database of importing
country.
Case No. 5: Import cases (Human) Form 5F

2082. Name, address of Applicant / M/s Gene Tech Laboratories 246/B-P.E.C.H.S. Block-6,
Importer Karachi
Details of Drug Sale License of License No: 10725
importer Address: Gene-tech Laboratories 246/B-P.E.C.H.S. Block-6,
Karachi
Validity: *15-August-2020
Status: Drug License By way of Wholesale
*The firm has submitted receipt for renewal of DSL dated
24/05/2020.
Name and address of marketing M/s Nano Fanavaran Darouei Alvand 1462, Pharmaceutical
authorization holder (abroad) Incubation Center, Avicenna Tech. Park of Tehran University
of Medical Sciences, North Kargar Ave., Tehran, Iran
Name, address of manufacturer(s) M/s Nano Fanavaran Darouei Alvand 1462, Pharmaceutical
Incubation Center, Avicenna Tech. Park of Tehran University
of Medical Sciences, North Kargar Ave., Tehran, Iran
Name of exporting country Iran
Detail of certificates attached  Legalized CoPP (Certificate Ref. 665/5405) 20-04-2019 by
(CoPP, Freesale certificate, GMP Ministry of Health and Medical Education declaring the free sale
certificate)

of applied product and GMP compliant status of the
manufacturer.
Details of letter of authorization / Product specific sole agency agreement is submitted.

sole agency agreement
Status of the applicant ☐ Manufacturer
☒ Importer
Intended use of pharmaceutical ☒ Domestic sale
product ☐ Export sale
For imported products, specify one ☒ Finished Pharmaceutical product import
the these ☐ Buk import and local repackaging
☐ Buk import and local repackaging for export purpose only
Dy. No. and date of submission Dy. No 7963 Dated 10-06-2019
Details of fee submitted Rs. 100,000/- Dated 29-05-2019
The proposed proprietary name / Alvocade Single use vial containing 3.5mg powder for injection
brand name
Strength / concentration of drug Each vial contains:
of Active Pharmaceutical Bortezomib powder….3.5mg
ingredient (API) per unit
Pharmaceutical form of applied Powder for Injection IV/Sc
drug
Pharmacotherapeutic Group of Anticancer
(API)
Reference to Finished product In-House
specifications
Proposed Pack size 1 vial box
Proposed unit price 73.2 Dollars
The status in reference regulatory Bortezomib 3.5 mg powder for solution for injection (UK)
authorities
For generic drugs (me-too status) Egybort injection by M/s Revive Pharma, Reg. No. 090738
Module-II (Quality Overall The submitted QOS is as per WHO-PD template.
Summary)
Name, address of drug substance M/s Laurus Labs Limited Plot no.21 Jawaharlal Nehru Pharma
manufacturer City, Parawada Visakhapatanma 531021 Andra Pradesh India.
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.
Stability Studies of Drug Submitted.
Substance Real time at -20oC±5oC for 12 months
(Conditions & duration of Accelerated study at 5oC±3oC for 6 months

Stability studies)
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 Firm has submitted complete data of formulation development
Comparative Dissolution Profile process. Firm has submitted comparative quantitative composition of
applied product along with reference product.
Firm has also submitted comparative table summarizing results of all
physico-chemical tests performed on 5 batches of applied product and
one batch of the reference product i.e. Omnipaque injection.
Analytical method Firm has submitted analytical method validation studies for the
validation/verification of product applied product.
Container closure system of the Glass vial
drug product
Stability study data of drug Firm has submitted stability study data of 3 batches The accelerated
product, shelf life and storage stability study data is conducted at 40oC ±2oC / 75% ± 5% RH for 6
conditions months. The real time stability study data is conducted at 30oC ±2oC
/ 75% ± 5% RH for 12 months.
Evaluation by PEC:
abroad.
2083. Name, address of Applicant / M/s Amgomed office # 4, First floor Ghausia Plaza, Jinnah
Importer Avenue Blue area Islamabad
Details of Drug Sale License of License No: DSL-002-ICT/2013
importer 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.
Status: Drug License by way of Wholesale
Name and address of marketing M/s ILDONG Pharmaceutical co., ltd. 25, gongdan 1-ro,
authorization holder (abroad) Anseong-si, Gyeonggi-do, Republic of Korea
Name, address of manufacturer(s) Manufacturing site:
Site responsible for batch release, primary and secondary
packaging:
M/s ILDONG Pharmaceutical co., ltd. 25, gongdan 1-ro,
Anseong-si, Gyeonggi-do, Republic of Korea
Detail of certificates attached CoPP: Original Legalized CoPP (Certificate#. 2019-D1-0700)
(CoPP, Freesale certificate, GMP by Ministry of Food and Drug Safety declaring the free sale of
certificate) applied product and GMP compliant status of the manufacturer
i.e M/s ILDONG Pharmaceutical co., ltd. Korea. Issued date:
Mar. 15, 2019
Details of letter of authorization / Authorization letter by manufacturer M/s ILDONG

sole agency agreement Pharmaceutical co., ltd. In the name of importer M/s Amgomed

registration, sale and distribution in Pakistan.
☒ Importer
☐Domestic and Export sales
The proposed proprietary name / SPECSSA Tablet 250mg
brand name (Gefitinib)
Strength / concentration of drug Each film coated tablet contains:
of Active Pharmaceutical Gefitinib…………..250mg
Pharmaceutical form of applied Tablet
drug
Pharmacotherapeutic Group of Anticaner
(API)
Reference to Finished product In house
specifications
Proposed Pack size 30’s
The status in reference regulatory IRESSA of USFDA
authorities
For generic drugs (me-too status) Gefticip 250mg Tablet of M/s AJMs
Module-II (Quality Overall Submitted. The QOS is as per WHO-PD template.
Summary)
Name, address of drug substance M/s Mac chem Products (India) Pvt. Ltd. N-211/2/10. Tarapur
manufacturer MIDC.
substance.
Stability Studies of Drug Real time at 30oC±2oC & 65%RH±5% of 3 batches for 24 months
Substance Accelerated at 40oC±2oC & 65%RH±5% of 3 batches for 24 months
(Conditions & duration of
Stability studies)

Pharmaceutical Equivalence and Submitted.
Comparative Dissolution Profile
Container closure system of the PVC blister and hard foil
drug product
Stability study data of drug Firm has submitted stability study data of 3 batches The accelerated
product, shelf life and storage stability study data is conducted at 40oC ±2oC / 75% ± 5% RH for 6
conditions months. The real time stability study data is conducted at 30oC ±2oC
/ 75% ± 5% RH for 36 months.
Evaluation by PEC:
Decsion: Approved with Innovator’s specifications as per Policy for inspection of Manufacturer
abroad.
2084. Name, address of Applicant / M/s Ahsan Pharma Room no.2 Delhi Muslim Building Aram
Importer Bagh Road, Karachi.
Details of Drug Sale License of Drug License by the way of Wholesale
importer License No: 0865
Address: Ahsan Pharma Room no.2 Delhi Muslim Building Aram
Bagh Road, Karachi.
Name and address of marketing M/s Seacross Pharmaceuticals Co., Ltd., Stanmore Bussiness &
authorization holder (abroad) Innovation Centre, Stanmore Place Howard Road, Stanmore London
HA7 1BT, UK.
Name, address of manufacturer(s) Manufacturer:
M/s Sichuan Huiyu Pharmaceutical Ltd. No. 5 Road Chengxi
economic area, Neijiang, Sichuan-641000, China
Batch Releasing site:
M/s Seacross Pharmaceutical Limited, Bedford business centre,
61-63 st. peter’s street, Bedford, Bedfordshire, MK40 2PR,
United Kingdom
Name of exporting country UK
Detail of certificates attached Original Legalized CoPP for Paclitaxel 6 mg/ml Concentrate for Solution
(CoPP, Freesale certificate, GMP for Infusion (Certificate#. PP10161139) dated 16-05-2019 by The
certificate) Medicines and Healthcare products Regulatory Agency, 10 South
Colonnade, Canary Wharf, London E14 4PU, United Kingdom
declaring the free sale of applied product and GMP compliant status
of the manufacturer.
Details of letter of authorization / Copy of Exclusive Distributionship Agreement is submitted. M/s

sole agency agreement Seacross Pharmaceuticals Co., Ltd., Stanmore Bussiness &
Innovation Centre, Stanmore Place Howard Road, Stanmore London
HA7 1BT, UK. authorizes M/s Ahsan Pharma, Zeenat Medicine
Market, A-5, First Floor, Napier Road, Karachi for marketing and
selling the the Seacross’ products including the applied product.
☒ Importer

☐Domestic and Export sales
Details of fee submitted (Rs. 100,000/- Dated 02-09-2019)
The proposed proprietary name / Paclitaxel 6mg/ml concentrate for solution for infusion
brand name
Strength / concentration of drug Each vial of 5ml contains:
of Active Pharmaceutical Paclitaxel…………30mg
Pharmaceutical form of applied Solution for injection
drug
Pharmacotherapeutic Group of antineoplastic
(API)
Reference to Finished product USP
specifications
The status in reference regulatory Paclitaxel 6 mg/ml Concentrate for Solution for Infusion (UK)
authorities
For generic drugs (me-too status) Paclitaxel Injection 30mg/5Ml of M/s Innopharm Karachi
Module-II (Quality Overall Submitted.
Summary)
Name, address of drug substance M/s Chongqing Taihao Pharmaceutical Co., Ltd. No.105,
manufacturer Chuangye Road, Erlang, Jiulongpo District, Chongqing, P. R.
China 400039
substance.
Stability Studies of Drug Real time stability studies (25oC±2oC 60%±5% RH) 24 months and
Substance Accelerated study (40oC±2oC 75%±5% RH) of 3 batches.
(Conditions & duration of
Stability studies)

Pharmaceutical Equivalence and The firm has submitted pharmaceutical equivalence against the
Comparative Dissolution Profile innovator product Taxol.
Container closure system of the Type I glass vial
drug product
Stability study data of drug Real time stability studies (25oC±2oC 60%±5% RH) 24 months and
product, shelf life and storage Accelerated study (40oC±2oC 75%±5% RH) of 3 batches.
conditions
Evaluation by PEC-I:
Decision: Deferred for clarification regarding storage conditions of stability study data of finished product
which is not as per Zone IVA.
Bagh Road, Karachi.
HA7 1BT, UK.
M/s Seacross Pharmaceutical Limited, Bedford business centre, 61-
63 st. peter’s street, Bedford, Bedfordshire, MK40 2PR, United
Kingdom
of the manufacturer

☒ Importer
brand name
Strength / concentration of drug of Each vial of 16.7ml contains:
Active Pharmaceutical ingredient Paclitaxel…………100mg
(API) per unit
Pharmaceutical form of applied Concentrate for solution for injection
drug
Pharmacotherapeutic Group of Antineoplastic agent
(API)
specifications
authorities
For generic drugs (me-too status) Ebetaxel 100mg/16.7Ml Injection M/s Bio Pharma
Summary)
China 400039
substance.
(Conditions & duration of Stability
studies)
Pharmaceutical Equivalence and The firm has submitted Pharmaceutical equivalence with innovator
Comparative Dissolution Profile product Taxol.
drug product

conditions
Evaluation by PEC:
Decision: Deferred for clarification regarding storage conditions for of stability study data of finished
product which is not as per Zone IVA.
Bagh Road, Karachi.
HA7 1BT, UK.
M/s Seacross Pharmaceutical Limited, Bedford business centre, 61-
63 st. peter’s street, Bedford, Bedfordshire, MK40 2PR, United
Kingdom
of the manufacturer

☒ Importer

brand name
Strength / concentration of drug of Each vial of 50ml contains:
Active Pharmaceutical ingredient Paclitaxel…………300mg
(API) per unit
Pharmaceutical form of applied Concentrate for solution for injection
drug
Pharmacotherapeutic Group of Antineoplastic agent
(API)
specifications
authorities
For generic drugs (me-too status) DRIFEN 300MG INJECTABLE SOLUTION M/s Haji Medicine
Summary)
China 400039
substance.
studies)
Pharmaceutical Equivalence and The firm has submitted Pharmaceutical equivalence with innovator
Comparative Dissolution Profile product Taxol.
drug product
conditions
Evaluation by PEC:
Decision: Deferred for clarification regarding storage conditions for of stability study data of finished
product which is not as per Zone IVA.
2087. Name, address of Applicant / Importer M/s Ahsan Pharma Room no.2 Delhi Muslim Building
Aram Bagh Road, Karachi.
Details of Drug Sale License of importer Drug License by the way of Wholesale
License No: 0865
Address: Ahsan Pharma Room no.2 Delhi Muslim Building
Aram Bagh Road, Karachi.
Name and address of marketing M/s Seacross Pharmaceuticals Co., Ltd., Stanmore
authorization holder (abroad) Bussiness & Innovation Centre, Stanmore Place Howard
Road, Stanmore London HA7 1BT, UK.
M/s Sichuan Huiyu Pharmaceutical Ltd. No. 5 Road
Chengxi economic area, Neijiang, Sichuan-641000, China
Detail of certificates attached (CoPP, Free sale certificate no. 2017-019 issued by Neijiang
Freesale certificate, GMP certificate) Bureau of Ministry of Commerce of the people’s
republic of China on 27/07/2017.
Eudra GMDP status checked from web dated 10-07-
2019 show that competent authority of the UK confirms
the following manufacturer M/s Sichuan Huiyu
Pharmaceutical Ltd. No. 5 Road Chengxi economic
area, Neijiang, Sichuan-641000, China has been
inspected dated 21/08/2017, it is considered that it
complies with the principle and guideline of GMP laid
down in Directive 2003/EC.
Details of letter of authorization / sole Copy of Exclusive Distributionship Agreement is submitted.
agency agreement M/s Seacross Pharmaceuticals Co., Ltd., Stanmore
Bussiness & Innovation Centre, Stanmore Place Howard
Road, Stanmore London HA7 1BT, UK. authorizes M/s
Ahsan Pharma, Zeenat Medicine Market, A-5, First Floor,
Napier Road, Karachi for marketing and selling the the
Seacross’ products including the applied product.
☒ Importer
☐ Export sale
For imported products, specify one the these ☒ Finished Pharmaceutical product import
☐ Buk import and local repackaging
The proposed proprietary name / brand Azacitidine Seacross powder for suspension for
name injection
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Azacitidine……..100mg

Pharmaceutical form of applied drug Powder for suspension for injection
Pharmacotherapeutic Group of (API) Antineoplastic agent
specifications
Proposed Pack size 1’s 30ml glass Vial
Proposed unit price Price as per SRO
The status in reference regulatory VIDAZA of Baxter Oncology GmbH 33790
authorities Halle/Westfalen Germany
For generic drugs (me-too status) Could not be confirmed
Module-II (Quality Overall Summary) Submitted.
Name, address of drug substance M/s Chongqing Taihao Pharmaceutical Co., Ltd.
manufacturer No.105, Chuangye Road, Erlang, Jiulongpo District,
Chongqing, P. R. China 400039
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 Real time stability studies (25oC±2oC 60%±5% RH) 24
(Conditions & duration of Stability studies) months and Accelerated study (40oC±2oC 75%±5% RH) 6
months of 3 batches.
process validation protocols, control of excipients, control of
drug product, specifications, analytical procedures,
Pharmaceutical Equivalence and Pharmaceutical equivalence is submitted against the
Comparative Dissolution Profile innovator product VIDAZA® by M/s Colgene.
As the product is intended to be administered Sc, therefore
In-vitro dissolution testing at 37oC against the innovator
product is submitted.
Analytical method validation/verification of Firm has submitted analytical method validation studies for
product the applied product.
Container closure system of the drug Type I glass vial
product
Stability study data of drug product, shelf Real time stability studies (30oC±2oC 65%±5% RH) 36
life and storage conditions months and Accelerated study (40oC±2oC 75%±5% RH) 6
months of 3 batches.
Evaluation by PEC:
FSC issuing authority Neijiang Bureau of Ministry of Commerce of the people’s republic of China which is not
concern regulatory authority i.e. China Food & Drug Administration.
Decision: Deferred for issuance of CoPP from relevant regulatory authority.
2088. Name, address of Applicant / M/s Genome Pharma House # 166-A, Street#9, Chaklala
Importer Scheme III, Rawalpindi

Details of Drug Sale License of License No: 0011000 0002403
importer Address: Genome Pharma Hpouse no. 166-A, streetno. 09. Chaklala
Scheme III, District Rawalpindi.
Validity: *28-Aug-2020.
Status: License to sell drugs as distributor
*the firm has submitted the receipt for renewal of DSL dated
25/08/2020.
Name and address of marketing M/s Anshi Pharmaceutical (Zhongshan) Inc National Health
authorization holder (abroad) Technology Park, Zhongshan, Guangdong Province China
Name, address of manufacturer(s) M/s Anshi Pharmaceutical (Zhongshan) Inc National Health
Technology Park, Zhongshan, Guangdong Province China
Detail of certificates attached  Original Legalized CoPP (Certificate#. 2018-0070) stamp and
(CoPP, Freesale certificate, GMP dated on 29-03-2018 by Guangdong Province Food and Drug
certificate) Administration, People’s Republic of China declaring the free
sale of applied product and GMP compliant status of the
manufacturer.
Details of letter of authorization / Copy of Product specific sole agency agreement is submitted.
sole agency agreement M/s Anshi Pharmaceuticals authorizes M/s Genome Pharma.
☒ Importer
Intended use of pharmaceutical ☐ Domestic sale
Details of fee submitted PKR: 100,000/- dated 30-10-2019
The proposed proprietary name / Neolymin 50mg Soft Gelatin Capsule
brand name
Strength / concentration of drug of Each soft gelatin Capsule contains:
Active Pharmaceutical ingredient Cyclosporin………..50mg
(API) per unit
Pharmaceutical form of applied Soft gelatin capsule
drug
Pharmacotherapeutic Group of ATC Code: L04AD01 IMMUNOSUPPRESSANTS, Calcineurin
(API) inhibitors
specifications
The status in reference regulatory Capimune 50 mg, Soft capsules of M/s Generics [UK] Limited t/a Mylan
authorities

For generic drugs (me-too status) SIGMASPORIN MICRORAL 50MG SOFT GELATIN CAPSULE M/s
UNIVERSAL ENTERPRISES
Summary)
Name, address of drug substance M/s Zhejiang Ruibang Laboratories No. 578, Binhai Ten Road,
manufacturer Economic and Technical Development Zone, Wenzhou,
Zhejiang 325025, China
substance.
Stability Studies of Drug Submitted for 03 batches (real time at 25oC for 2 years and accelerated
Substance for 6 months).
studies)
standard or materials etc.
Pharmaceutical Equivalence and The data is submitted against the reference product.
Container closure system of the Submitted.
drug product
Stability study data of drug Firm has submitted three batches long term stability data (24 months)
product, shelf life and storage at 30±20C, 65±5%RH and 6 months at 400C±75%RH.
conditions
Submitted comparative dissolution profile of applied Neolymin 50mg Soft Gelatin Capsule with Neoral 25mg,
Justify.
(The firm has stated that the formulation of cyclosporine capsule 25mg and 50mg is proportional and the
manufacturing process is the same.)
Decision: The Board deferred the case for submission of comparative dissolution profile of the applied
product against the reference product of the same strength that is 50mg.
2089. Name, address of Applicant / M/s Genome Pharma House # 166-A, Street#9, Chaklala
Importer Scheme III, Rawalpindi
Details of Drug Sale License of License No: 0011000 0002403
importer Address: Genome Pharma Hpouse no. 166-A, streetno. 09. Chaklala
Scheme III, District Rawalpindi.
Validity: *28-Aug-2020.
Status: License to sell drugs as distributor
*the firm has submitted the receipt for renewal of DSL dated
25/08/2020.
Name and address of marketing M/s Anshi Pharmaceutical (Zhongshan) Inc National Health
authorization holder (abroad) Technology Park, Zhongshan, Guangdong Province China
Name, address of manufacturer(s) M/s Anshi Pharmaceutical (Zhongshan) Inc National Health
Technology Park, Zhongshan, Guangdong Province China
Detail of certificates attached Original Legalized CoPP (Certificate#. 2018-0069) stamp and
(CoPP, Freesale certificate, GMP dated on 29-03-2018 by Guangdong Province Food and Drug
certificate) Administration, People’s Republic of China declaring the free sale of
applied product and GMP compliant status of the manufacturer..
Details of letter of authorization / Copy of Product specific sole agency agreement is submitted.
sole agency agreement M/s Anshi Pharmaceuticals authorizes M/s Genome Pharma.
☒ Importer
Details of fee submitted PKR: 100,000/- dated 30-10-2019
The proposed proprietary name / Neolymin 25mg Soft Gelatin Capsule
brand name
Strength / concentration of drug of Each soft gelatin Capsule contains:
Active Pharmaceutical ingredient Cyclosporin………..25mg
(API) per unit
Pharmaceutical form of applied Soft gelatin capsule
drug
Pharmacotherapeutic Group of ATC Code: L04AD01 IMMUNOSUPPRESSANTS, Calcineurin
(API) inhibitors
specifications
The status in reference regulatory Capimune 25 mg, Soft capsules of M/s Generics [UK] Limited t/a Mylan
authorities
For generic drugs (me-too status) SIGMASPORIN MICRORAL 25MG SOFT GELATIN CAPSULE M/s
UNIVERSAL ENTERPRISES
Summary)
Name, address of drug substance M/s Zhejiang Ruibang Laboratories No. 578, Binhai Ten Road,
manufacturer Economic and Technical Development Zone, Wenzhou,
Zhejiang 325025, China
substance.
Stability Studies of Drug Submitted for 03 batches (real time at 25oC for 2 years and accelerated
Substance for 6 months).
studies)
drug product
product, shelf life and storage at 30±20C, 65±5%RH and 6 months at 400C±75%RH.
conditions
The seal of the submitted CoPP is not intact.
Decision: Approved as per Import Policy for finished drugs. Firm will submit valid CoPP for further
processing of case.
2090. Name, address of Applicant / M/s M/s OBS Pakistan Pvt. Ltd., C-14, Manghopir Road,
Importer S.I.T.E. Karachi
Details of Drug Sale License of License No: 0950
importer Address: OBS Pakistan PVt LTD Plot No. C-14, Manghopir Road
Site area Karachi.
Validity26-03-2021
Status: Drug License by Way of Wholesale
Name and address of marketing Product License Holder: Merck Sharp and Dome B.V.,
authorization holder (abroad) Waarderwg 39, 2031 BN Haarlem, the Netherlands.
Name, address of manufacturer(s) Manufactured by: Steri Pharma, LLC 429S.West street Syracuse,
NY 13202, USA
Released By: Laboratoires Merck Sharp & Dohme Chibret, Route de
Marsat-Riom, 63963 Clermont Ferrand Cedex 9, France
Name of exporting country Netherland
Detail of certificates attached Original Legalized CoPP (Certificate#. 2FM2-4328) by USFDA
(CoPP, Freesale certificate, GMP declaring the free sale of applied product and GMP compliant status
certificate) of the manufacturer. Certificate Expiration Date: June 24, 2021.
Details of letter of authorization / Copy of sole agency agreement is submitted. MSD authorizes M/s
sole agency agreement OBS Pakistan.
☒ Importer

Dy. No. and date of submission Dy. No. 21535 Dated 22-10-2019
The proposed proprietary name / Zerbaxa, Powder for concentrate for solution for infusion
brand name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Ceftolozane …1gm (eq. to 1.147g of ceftolozane sulfate)
(API) per unit Tazobactam… 0.5g (eq. to 0.537g of tazobactam sodium)
Pharmaceutical form of applied Powder for concentrate for solution for injection
drug
Pharmacotherapeutic Group of Antibiotic
(API)
Reference to Finished product In-house
specifications
Proposed Pack size 10’s vials
Proposed unit price As per DPC
The status in reference regulatory USFDA Approved
authorities
For generic drugs (me-too status) Could not be confirmed
Summary)
Name, address of drug substance M/s Ceftolozane:
manufacturer M/s Acs Dobfar, S.p.A (ACSD4) via Marzabotto, 1,7/9 20871
vimercate (MB) Italy.
Tazobactam sodium:
M/s Qilu Tianhe Pharmaceutical Co., Ltd. No. 849 Dongjia
Town, Licheng District, 250105 Jinan, Shandong Province,
P.R. of China
substance.
Stability Studies of Drug Submitted.
Substance
studies)

drug product
product, shelf life and storage at 5±30C and 6 months at 250C±60%RH for three batches.
conditions
Remarks of Evaluator-I:
QOS of module 2 is complete but not as per WHO/Form-5F format.
The firm has submitted that the name of legal entity of drug substance manufacturer (Tazobactam Sodium) has
been changed from “Qilu Tianhe Pharmacetuical Co., Ltd. to “Shandong Anxin Pharmacetuical Co., Ltd. The
firm has stated that the manufacturing site is not changed.Valid GMP of the manufacturer mentioning the
changed name and address along with the old name and address of the API manufacturer (certificate no.
IT/E/API/04/2020, issued on the basis of inspection conducted on 18-09-2019) is submitted along with the reply.
Moreover, updated relevant section (2.3.s.2.1) is submitted as well.
Name and address: M/s Shandong Anxin Pharmaceutical Co., Ltd (formerly Qilu Tianhe Pharmaceutical Co.,
Ltd) No. 10678 Wenliang Road, Dongja town, Licheng District (former No. 849 Dongja town, lichen District,
Jinan Shandong, 250105, China.
Decision: Deferred for submission of complete S part of module 2 and 3 of CTD.
2091. Name, address of Applicant / M/s Timax Life Sciences Pvt. Ltd. Mezzanine-1, FL-37, Block-
Importer B, Gulshan-e-Jamal Karachi
Details of Drug Sale License of Address: Timax Life Scineces Pvt. Ltd. M-1, Fl-37, Block-B,
importer Gulshan e Jamal Karachi
Name and address of marketing M/s Biem Ilac San. Ve Tic. A.S Turgut Reis Cad. No: 21 06570
authorization holder (abroad) Tandogan-ANKARA/ TURKEY
Name, address of manufacturer(s) M/s Mefar Ilac Sanayii A.S. Ramazanoglu Mah. Ensar Cad. No: 20
Kurtkoy-Pendik/ Istanbul-Turkey
Detail of certificates attached Original Legalized CoPP (Certificate#. 2018/2468) issued on 28-06-
(CoPP, Freesale certificate, GMP 2018 by Republic of Turkey Ministry of Health Turkish Medicines
certificate) and Medical Devices Agency declaring the free sale of applied
product and GMP compliant status of the manufacturer i.e., M/s
Mefar Ilac Sanayii A.S. Ramazanoglu Mah. Ensar Cad. No: 20
Kurtkoy-Pendik/ Istanbul-Turkey valid until 28/06/2020.
Details of letter of authorization / Original legalized Authorization letter from Product License
sole agency agreement Holder: M/s Biem Ilac San. Ve Tic. A.S Turgut Reis Cad. No:
21 06570 Tandogan-ANKARA/ TURKEY in the name of
importer M/s Timax Life Sciences Pvt. Ltd. Mezzanine-1, FL-
37, Block-B, Gulshan-e-Jamal Karachi for product MRSACIN-
50mg containing lyophilized powder for IV infusion is
submitted
☒ Importer

The proposed proprietary name / MRSACIN
brand name
Strength / concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Lyophilized tigecycline…..50mg
(API) per unit
Pharmaceutical form of applied Lyophilized powder for solution for IV infusion
drug
Pharmacotherapeutic Group of Antibacterial
(API)
specifications
The status in reference regulatory Tygacil 50 mg powder for solution for infusion (Belgium)
authorities
For generic drugs (me-too status) Tygatec 50mg Injection of M/s Safe Pharmaceuticals (Pvt) Ltd.
Karachi
Module-II (Quality Overall submitted
Summary)
Name, address of drug substance M/s UNIMARK REMEDIES LIMITED 501, 5th Floor, E-
manufacturer Wing, Sky Park CHS Ltd., MMRDA District Centre, Oshiwara
Garden Road, Off. S.V. Road, Goregaon (West) Mumbai India
substance.
Stability Studies of Drug The firm has submitted real time stability study data 25oC±2 and
Substance 60%±5 for 2 years and accelerated at 40oC±2 and 75%±5.
studies)

drug product
Stability study data of drug The firm has submitted real time stability study data 25oC±2 and
product, shelf life and storage 60%±5.
conditions
Remarks of Evaluator-I:
Stability study data (Real time + Accelerated) according to the conditions of Zone-IVA required.
Decision: Deferred for submission of real time and accelerated stability data of 03 batches according to the
Case no.6: Deferred cases (import) submitted on Form 5F

2092. Nab-Xelpac Injection (Lyophilized Powder) applied by M/s Himmel Pharmaceuticals (Pvt.) Ltd
Lahore
MODULE 1: ADMINISTRATIVE
Section Sub- Heading
Section
1.1 Covering Letter and Fee Deposit Slip Submitted
Dy. No 26966 Dated 13-12-2019 PKR: 50,000/- dated 19-03-2019
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 Himmel Pharmaceuticals (Pvt.) Ltd, 793-D, Block C Faisal Town Lahore
1.3.2 Name, address and contact details of Manufacturing site.
Product License Holder & Manufacturer:
M/s BEACON Pharmaceuticals Limited
Plant address: Kathali, Bhaluka, Mymensingh Bangladesh
Office Address: 9/A, Toyenbee Circular Road, Motijheel Dhaka, Bangladesh
1.3.3 Specify whether the Applicant is:
Importer
1.3.4 Drug Sale License
License to Sell drugs as a Distributor No: 0011000 0001520 valid upto 06-Feb-2020
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.
Nanoparticle Albumin bound Paclitaxel USP
1.5.2 Strength / concentration of drug of Active Pharmaceutical ingredient (API) per unit
Each vial contains:
Nanoparticle Albumin bound Paclitaxel USP …..100mg
1.5.3 The proposed proprietary name / brand name under which the drug is intended to be sold
with trademark certification / clearance.
Nab-Xelpac Injection (Lyophilized Powder)

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 & As per SRO
1.5.5 Pharmacotherapeutic Group of Active Pharmaceutical Ingredient (API)
Antineoplastic agents
1.5.6 Pharmacopoeial reference / Status of applied formulation
USP
1.5.7 Route of administration
IV
1.5.8 For Generic Drug Product, reference of other similar approved medicines with information
pertaining to Manufacturer name, brand name, strength, composition, registration number &
dosage form, Pack size and Price
ONCOTAXEL 100MG INJECTION of M/S. PHARMEVO (PRIVATE) LIMITED,
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.
Abraxane 5 mg/ml powder for suspension for infusion (Netherlands)
1.5.10 Dosage form of applied drug
Injection (Lyophilized Powder) : 100mg
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 & Adverse 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.
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.
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
1.6.5 Drug Substance related Document including following:
Name and address of API manufacturer.
 Original Legalized CoPP (Certificate#. DA/6-110/2016/3677) issued on 18-02-2018 by Govt. of

the people’s republic of Bangladesh, Ministry of Health & Family welfare, Directorate General of
Drug Administration, declaring the free sale of applied product and GMP compliant status of the
manufacturer i.e., M/s BEACON Pharmaceuticals Limited.
 Copy of Product specific sole agency agreement is submitted.
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
Manufacture 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
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 Not submitted
3.2.S.2.5 Process Validation and/or Evaluation 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
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.2.1.2 Excipients 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 Submitted
3.2.P.3 MANUFACTURE
3.2.P.3.1 Manufacturer(s) Submitted
Name and full address(es) of the facility(ies)
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.5 CONTROLS OF DRUG PRODUCT
3.2.P.5.1 Specification(s) Submitted
3.2.P.5.2 Analytical procedures Submitted
3.2.P.5.3 Validation of analytical procedures Submitted
3.2.P.5.4 Batch analysis Submitted
3.2.P.5.5 Characterization of impurities Submitted
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 Not applicable
3.2.P.8.3 Stability Submitted
Firm has submitted three batches long term stability data (24 months) at 30±20C,
65±5%RH and 6 months at 400C±75%RH.
Decision of 293rd meeting: Deferred for submission of all commitments of module 1.
Evaluation by PEC: The firm has submitted all the commitments of module I.
Deferred cases of COVID-19

Sr. Applicant Brand Composition Dy No./fee/ Pack GMP status Previous
No. name date/ form size decision
and
price
2093. M/s Ajicin Each 5ml Dy.No. 12453 As M/s Deferred in
Cunningham 200mg/ reconstituted dated per Novamed: 295th meeting
Pharmaceutic 5ml for Suspension Contains: 03/06/2020Rs. Sro, 22-1-2019 for contract
als Pvt Ltd. Suspen Azithromycin 50,000/- dated As Good level agreement,
Plot # 81, sion Dihydrate Eq. to 03-06-2020 per of No of existing
Sunder Azithromycin…200m Form 5 Sro compliance products on
Industrial g with GMP. contract
Estate, manufacturi
Raiwind Road ng, total
Lahore, sections and
Pakistan justification
Contract if firm has
manufactured own facility
By of
M/s Novamed manufacturi
Pharmaceutic ng
als (Pvt) Ltd.
28-
km,Ferozepur
e road Lahore

The firm has submitted the following;
 Original contract agreement with M/s Novamed Pharma.
 No products are being manufactured on contract basis for M/s Cunningham Pharma.
 Copy of GMP certificate dated 19/04/2019 issue don the basis of inspection conducted on 01/04/2019.
 M/s Cunningham pharma has 7 approved sections.
 The firm does not have the relevant section.
2094. M/s Harmann Citaqui Each Film Coated Dy.No. 9126 As Deferred in
Pharmaceutic ne DS Tablet contains: dated per 30,000/- fee 295th meeting
al Tablet Chloroquine 28/04/2020 PRC alongwith for
Laboratories phosphate………..50 Rs. 20,000/- Fom-5D is submission of
(Pvt.) Ltd, 16- 0mg Form 5 required. Form 5D
Km Multan along with
Road, Lahore the
submission of
Differential
fee of Rs.
30,000/
The firm has submitted Form 5D and Differential fee of Rs. 30,000/- vide challan number 0792484 dated
09/06/2020.
GMP inspection dated 13-11-2019 shows that the firm was allowed resumption of production activities in
all sections except Sterile Liquid Section of the firm M.s Harmann Laboratories Lahore in as per
recommendation of panel inspection report dated 09-10-2019 in following sections.
a- Sterile Section-I (General Injection)
b- Sterile Section-III (Hormonal Injection).
2095. Applicant: Lopvir Each Dy.No. As GMP Deferred for the following:
M/S CSH 200mg/ Tablet 9318 per certificate  Submission of details of
Pharmaceutic 50mg Contains: dated SRO issued to products which are already
als Pvt Ltd. Tablet Lopinavir 29/04/202 M/s being manufactured on
32-km, …200mg 0Rs. Medisave contract and detail of number
Ferozepur Ritonavir 50,000/- pharmace of approved sections.
Road, Lahore …50mg dated 29- uticals on  Registration Board referred
Mfg by: 04-2020 22/01/202 the case to QA & LT Division
Medisave Form 5D 0 on the to conduct GMP inspection of
Pharmaceutic basis of M/s CSH Pharma on priority.
als Plot no. inspectio  submission of requisite fee for
578-579, n revision of formulation as per
sundar conducte the reference product.
industrial d on
estate, Sundar 02/10/201
raiwind road, 9.
Lahore
The firm has submitted;
 Fee of Rs, 5,000/- vide challan number 2039502 dated 09/06/2020 for revision of formulation from uncoated
to film coated as per the reference product. The correct label claim is given in the following;
Lopinavir…..200mg
Ritonavir…...50mg
 No product is being manufactured for M/s CSH Pharma on contract basis.
 Inspection report dated 04/05/2020, satisfactory level of GMP compliance.
 The firm has 3 approved sections (letter No.F.1-100/2005-Lic(Vol-I) dated 1st Aug, 2012.

2096. Applicant: Hydrox Each film Dy.No. As GMP Deferred in 295th meeting for the
M/S CSH y coated 9315 per inspectio following:
Pharmaceutic Tablet tablet dated SRO n of M/s  Submission of details of
als Pvt Ltd. 200mg contains: 29/04/202 Medisave products which are already
32-km, Hydroxych 0Rs. Pharmace being manufactured on
Ferozepur loroquine 50,000/- uticals, contract and detail of number
Road, Lahore sulfate…2 dated 29- Plot No. of approved sections.
Mfg by: 00mg 04-2020 578, 579,  Registration Board referred
Medisave Form 5 Sundar the case to QA & LT Division
Pharmaceutic Industrial to conduct GMP inspection of
als Plot no. Estate, M/s CSH Pharma on priority.
578-579, Lahore  Submission of requisite fee for
sundar revision of formulation as per
industrial the reference product.
estate, Sundar
raiwind road,
Lahore
 Fee of Rs, 5,000/- vide challan number 2039501 dated 09/06/2020 for revision of formulation from uncoated
to film coated as per the reference product. The correct label claim is given in the following;
Hydroxychloroquine sulfate…200mg
2097. Applicant: Ostar Each Dy.No. As GMP Registration Board referred in
M/S CSH 75mg capsule 9316 per inspectio 295th meeting the case to QA &
Pharmaceutic Capsule contains: dated SRO n of M/s LT Division to conduct GMP
als Pvt Ltd. Oseltamivi 29/04/202 Medisave inspection of Firm on priority.
32-km, r as 0 Rs. Pharmace
Ferozepur phosphate 20,000/- uticals,
Road, Lahore ……….75 Form 5 Plot No.
Mfg by: mg 578, 579,
Medisave Sundar
Pharmaceutic Industrial
als Plot no. Estate,
578-579, Lahore
sundar
industrial
estate, Sundar
raiwind road,
Lahore
2098. Deleted due to duplication
2099. M/s Espoir Chloqui Each film coated Dy.No. 7779 As Inspection Deferred in
Pharmaceutic ne tablet contains: dated per date 295th meeting
als. Tablet Chloroquine 16/04/2020Rs. SRO 06/08/2019. for
PCSIR KLC 500mg phospate….500mg 20,000/- dated. The panel submission of
TBIC-II 16-04-2020 recommende Form 5D
PCSIR Form 5 d resumption along with
Laboratory the
th
Complex, of submission of
Shahrah-e-Dr. production Differential
Salim Uz Form 5D fee of Rs.
Zaman along with 30,000/-
Siddiqui Off differential
University fee of Rs.
Road, 30,000/- is
Karachi required..
The firm has submitted differential fee of Rs. 30,000/- vide challan number 2025155 dated 06/05/2020 along with
Form 5D.
2100. M/s Maple C-Sure Each tablet contains: Dy.No. 7258 GMP Deferred in
Pharmaceutic Tablet Ascorbic dated certificate 295th meeting
als Pvt Ltd 500mg Acid…500mg 14/04/2020Rs. issued on for evidence
Plot No.147, 20,000/- dated 22/01/2020 of approval
Sector 23, 14-04-2020 on the basis of applied
Korangi Form 5 of inspection formulation
Industrial conducted on in reference
Area, Karachi 22/12/2020. regulatory
The firm has authorities /
applied for agencies
plain tablet which were
while it is adopted by
approved in the
reference Registration
country as Board in its
chewable 275th
meeting.
The firm has revised the formulation from Tablet to Chewable tablet as per the reference product along with method
of manufacturing, master formula and other relevant documents with the submission of fee of Rs. 20,000/- vide challan
number 2001182 dated 18/08/2020.
2101. M/s Pharma Macazit Each Film Coated Dy.No. 11497 6’s 03/05/2019 Deferred in
Lord (Pvt) 500mg Tablet Contains: dated as inspection 295th meeting
Ltd. Tablet Azithromycin as 19/05/2020Rs. per dated. The for
12 KM, Dihydrate..…500mg 20,000/- dated SRO panel submission of
Lahore Raod, 19-05-2020 recommende method of
Layyah, Form 5 d renewal of manufacturi
Punjab DML. ng.

The firm has submitted method of manufacturing for the applied product.
2102. M/s Linz Azax Each Capsule Dy.No. 11721 6’s Inspection Deferred in
Pharmaceutic 250mg Contains: dated as date 295th meeting
als Pvt Ltd Capsule Azithromycin as 21/05/2020Rs. per 09/01/2020, for updated
Plot No 31-G Dihydrate Eq. to 20,000/- SRO GMP of the status of
& 31-H, Azithromycin……25 (#1962153) firm is rated GMP from
Sector 15 0mg dated 21-05- as Good. QA & LT.
Korangi 2020 Form 5
Induatrial
Area Karachi
The firm has submitted last inspection report dated 09/01/2020, the report concludes that the firm was operating at
acceptable level of GMP compliance.
New Applications related to COVID-19 (Import)
2103. Name and address of Applicant M/s Trans-Continental Pharma (pvt) Ltd. 23-B Gul Plaza Charsada
Road, KPK Peshawar.
Name: Trans-Continental Pharma (pvt) Ltd, Office No. 13-14-B,
Gul Plaa Charsada Road Peshawar.
No. 736WSL
Product License Holder & Manufacturer: M/s The Government Pharmaceutical Organization,
Manufacturer 138 Moo 4, Rangsit-Nakhonnayok Rd., Thanyaburi, Pathumthani
12110, Thailand.
MAH:
Name of exporting country Thailand
Brand Name +Dosage Form + Strength Oseltamivir Phosphate Capsule 75mg
Oseltamivir as Phosphate……75mg
Pharmacological Group antiviral
International availability Tamiflu 75mg capsule (oseltamivir as phosphate) by M/s
Roche, USFDA Approved.
Me-too status Tamiflu 75mg capsule by M/s Roche.
Stability studies Accelerated stability study data of 03 batches for 6 months
Real time stability data of 03 batches for 09months is submitted
Detail of certificates attached Medicinal product certificate
Certificate No: 1-2-03-03-19-01129
Certified by: Food and Drug Administration Ministry of
Public health
Free sale: yes
GMP status:
Copy of GMP certificate No. 1-2-07017-20-00007 isuued by
Food and Drug Administration, Ministry of public health is
attached.
Remarks of the Evaluator. Real time stability data is till 9 months,
Decision: Deferred for confirmation of shelf life as 9 months stability data has been submitted
2104. Name and address of Applicant M/s Trans-Continental Pharma (pvt) Ltd. 23-B Gul Plaza Charsada
Road, KPK Peshawar.
Name: Trans-Continental Pharma (pvt) Ltd, Office No. 13-14-B,
Gul Plaa Charsada Road Peshawar.
No. 736WSL
Product License Holder & Manufacturer: M/s The Government Pharmaceutical Organization,
Manufacturer 138 Moo 4, Rangsit-Nakhonnayok Rd., Thanyaburi, Pathumthani
12110, Thailand.
MAH:
Name of exporting country Thailand

Brand Name +Dosage Form + Strength Lopinavir/Ritonavir Tablet 200/50mg
Lopinavir……200mg
Ritonavir…….50mg
Pharmacological Group Anti retroviral
Shelf life 2 years
Pack size & Demanded Price Rs. 15,500/- per 120 tablets
International availability Kaletra (200mg/50mg & 100mg/25mg) Film coated tablet by
M/s Abbvie, USFDA Approved.
Me-too status Lopinavir/Ritonavir Tablets 200mg/50mg By M/S Scitech
Health (Private) LIMITED, Rweg No. 62250
Stability studies Accelerated stability study data of 03 bathes for 6 months
Real time stability data of 03 batches for 24 months is submitted as
per Zone IVA
Detail of certificates attached Medicinal product certificate
Certificate No: 1-2-03-03-20-00304
Certified by: Food and Drug Administrtaion Ministry of
Public health
Free sale: Yes
GMP status:
Copy of GMP certificate No. 1-2-07017-20-00007 isuued by
Food and Drug Administration, Ministry of public health is
attached.
Case no. 01 Review of the previously presented cases

Following application was approved in 286th meeting of Registration Board held on 14th - 16th November, 2018.
During subsequent processing of the said case, it has been identified that the evidence of approval of applied
formulation i.e., “Each capsule contain Gabapentin …. 60mg” is not verifiable from any of the reference
regulatory authorities, rather “Gabapentin 600mg tablet” is approved by US FDA. Hence the case is presented
before the Board for re-consideration.
2123. Name and address of manufacturer / M/s Parkar Pharma. Plot No. O/7-A, S.I.T.E Area
Applicant Kotri, Sindh
Brand Name +Dosage Form + Strength Parkopentin 600mg Capsule
Gabapentin…600mg
Diary No. Date of R& I & fee Dy.No 24892 dated 18-07-2018 Rs.20,000/- Dated 16-
07-2018
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per Drap Policy

Me-too status Kendis Tablets 600mg Reg # 064838
GMP status The CLB in its 259th meeting held on 29th and 30th March
2018 has considered and approved the grant of DML by
way of formulation.
a) Tablet (General Section)
b) Capsule (General Section)
c) Liquid Syrup (General Section)
Decision: Registration Board rejected the application as applied formulation is not approved
by any reference regulatory authority and firm has not submitted safety and efficacy data.

a. New cases
2124. Name and address of "M/s Medizan Laboratories (Pvt) Ltd, Plot No. 313, Industrial
manufacturer / Applicant Triangle, Kahuta road, Islamabad
M/s Ipram International. Plot No. 26, S.S, National Industrial
Zone, Rawat, Islamabad"
Brand Name +Dosage Form + Merolit 1gm Injection
Strength
Composition "Each vial contains:
Meropenem……1gm"
Diary No. Date of R& I & fee Dy. No 16389 dated 07-03-2019 Rs50,000/- Dated 07-03-2019
Type of Form Form-5
Me-too status (with strength and Mopen 1gm Injection of M/s Hilton Pharma
dosage form)
concludes grant of GMP certificate.
II
Remarks of the Evaluator Initially form has submitted stability study reports for accelerated
conditions but now the applicant has requested a sunder:
“This is our product Merolit 500mg & 1gm, its me too status is
available, we want to withdraw its stability and require normal
approval of product.”
Decision: Deferred for consideration as per queue.
2125. Name and address of "M/s Medizan Laboratories (Pvt) Ltd, Plot No. 313, Industrial
manufacturer / Applicant Triangle, Kahuta road, Islamabad
M/s Ipram International. Plot No. 26, S.S, National Industrial
Zone, Rawat, Islamabad"
Brand Name + Dosage Form + Merolit 500mg Injection
Strength
Composition "Each vial contains:
Meropenem…500mg"
Diary No. Date of R& I & fee Dy. No 16390 dated 07-03-2019 Rs50,000/- Dated 07-03-2019
Type of Form Form-5
Me-too status (with strength and Mopen 500mg Injection of M/s Hilton Pharma
dosage form)
concludes grant of GMP certificate.
Remarks of the Evaluator II
Decision: Deferred for consideration as per queue.

b. Deferred cases
2126. Name and address of manufacturer / M/s Espoir Pharmaceuticals. PCSIR KLC TBIC-II PCSIR
Applicant Laboratory Complex, Shahrah-e-Dr. Salim Uz Zaman Siddiqui
Off University Road, Karachi
Brand Name +Dosage Form + Strength Zibix 200mg Tablet
Celecoxib………200mg
Diary No. Date of R& I & fee Dy.No.16179 dated 02-05-2018 Rs.20,000/- 02-05-2018
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, & 30’s As per SRO
Approval status of product in Not found
Me-too status (with strength/dosage form) Coxia 200 mg Tablets of M/s Genome Pharmaceuticals
GMP status Last GMP inspection conducted on 28-09-2017 and the report
concludes that firm was found at good level of GMP.
Remarks of the Evaluator Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/ approved by the Registration
Previous decision (291): Deferred for the following:
 Confirmation of DML status.
Firm’s response  Following reference has been verified: “Celebrex 200mg capsule”
of M/s Upjohn UK Limited approved by MHRA of UK whereas
applied formulation is of tablet dosage form.
 Firm has submitted copy of letter from Secretary CLB dated 14-
02-2020, wherein Renewal of DML w.e.f 05-10-2017 has been
issued.
2127. Name and address of manufacturer / "M/s Espoir Pharmaceuticals. PCSIR KLC TBIC-II PCSIR
Applicant Laboratory Complex, Shahrah-e-Dr. Salim Uz Zaman
Siddiqui Off University Road, Karachi"
Brand Name +Dosage Form + Strength Zorfix 10mg/10mg Tablet
Composition "Each film coated Tablet Contains:
Atorvastatin (as calcium trihydrate) …10mg"
Diary No. Date of R& I & fee Dy. No 28143 dated 17-08-2018 Rs.20,000/- 17-08-2018
Pharmacological Group Calcium channel blocker/ HMG CoA reductase inhibitors
Type of Form Form 5
Me-too status (with strength and dosage Combitrol 10/10 tablet by M/s Ferozsons Labs. (Reg#050815)
form)
GMP status GMP certificate issued on the basis of inspection conducted on
18-05-2017.
II
Previous decision (M-291) Deferred for confirmation of valid DML status of the firm from
Licensing Division.
Firm’s response Firm has submitted copy of letter from Secretary CLB dated 14-
issued.

2128. Name and address of manufacturer / "M/s Espoir Pharmaceuticals. PCSIR KLC TBIC-II PCSIR
Brand Name +Dosage Form + Strength Zorfix 5mg/10mg Tablet
Composition "Each film coated Tablet Contains:
Atorvastatin (as calcium trihydrate) ……10mg"
Diary No. Date of R& I & fee Dy. No 28142 dated 17-08-2018 Rs.20,000/- 17-08-2018
Pharmacological Group Calcium channel blocker/ HMG CoA reductase inhibitors
Type of Form Form 5
Me-too status (with strength/dosage form) Atease 5+10mg Tablet by M/s PharmEvo (Reg#050559)
GMP status GMP certificate issued on the basis of inspection conducted on
18-05-2017.
Remarks of the EvaluatorII
Previous decision (291): Deferred for the following:
 Confirmation of DML status.
Firm’s response  Following reference has been verified: “Caduet tablet” of M/s
PHARMACIA approved by US FDA.
 Firm has submitted copy of letter from Secretary CLB dated 14-
issued.
2129. Name and address of manufacturer / "M/s Espoir Pharmaceuticals,PCSIR KLC TBIC-II PCSIR
Brand Name +Dosage Form + Strength Litamet 15/500 mg Tablet

Pioglitazone as HCl…15mg
Metformin HCl…500mg"
Diary No. Date of R& I & fee Dy. No 771 dated 07-01-2019 Rs.20,000/- Dated 03-01-2019
Type of Form Form 5
Pack size & Demanded Price 7’s,14’s, 28’s, As per SRO.
Approval status of product in Reference ACTOPLUS MET
Regulatory Authorities. USFDA Approved with box warning.
Prefair 500/15mg
M/s Merck, Balochistan
GMP status Last inspection conducted on 28-09-2017 and report concludes
that firm is found at good level of GMP compliance
Remarks of the Evaluator (V) The applied formulation is "Each Film Coated Tablet Contains:
Pioglitazone as HCL…15mg whereas, firm has mentioned in
master formulation "Each Film Coated Tablet Contains:
Pioglitazone HCL…15mg.
Previous decision (295): Deferred for submission of applied formulation in line with
reference product alongwith submission of composition/label
claim & master formulation accordingly.

Firm’s response Firm has submitted revised master formulation in line with the
reference product i.e.,
Decision: Approved.
2130. Name and address of manufacturer / "M/s Espoir Pharmaceuticals,PCSIR KLC TBIC-II PCSIR
Brand Name +Dosage Form + Strength Litamet 15/850 mg Tablet

Metformin HCl…850mg"
Type of Form Form 5
Pack size & Demanded Price 7’s,14’s, 28’s, As per SRO.
Approval status of product in Reference ACTOPLUS MET
Regulatory Authorities. USFDA Approved with box warning.
Muppet 15mg/850mg Tablet
M/s PPP, Karachi.
GMP status Last inspection conducted on 28-09-2017 and report concludes
that firm is found at good level of GMP compliance
Remarks of the Evaluator (V) The applied formulation is "Each Film Coated Tablet Contains:
Pioglitazone as HCL…15mg whereas, firm has mentioned in
master formulation "Each Film Coated Tablet Contains:
Pioglitazone HCL…15mg.
Previous decision (295): Deferred for submission of applied formulation in line with
reference product alongwith submission of composition/label
claim & master formulation accordingly.
Firm’s response Firm has submitted revised master formulation in line with the
Decision: Approved.
2131. Name and address of manufacturer / M/s Espoir Pharmaceuticals, Laboratory Complex, Shahrah-e-Dr.
Applicant Salim Uz Zaman Siddiqui Off University Road, Karachi
Brand Name+Dosage Form + Strength Azimed 250mg Capsule
Azithromycin dihydrate…250mg
Me-too status Azithromycin 250mg Capsules Unipharma (Pvt) Ltd., 071421
GMP status 28-09-2017 and good
Remarks of the Evaluator XIII  Azithromycin “as” dihydrate is approved in MHRA.
 Manufacturing facility / section needs to be confirmed.
Previous Decision (M-295) Deferred for evidence of approval of relevant/required
manufacturing facility and revision of formulation as per the
innovator / reference product along with submission of fee for
Firm’s response  Firm has submitted revised master formulation in line with the
“Each Capsule Contains:
Azithromycin as dihydrate……250mg”
 Firm has submitted copy of letter from Secretary CLB dated
14-02-2020, wherein Renewal of DML w.e.f 05-10-2017 has
been issued including the section of “Capsule (general)”.
Decision: Approved as per following composition:
“Each Capsule Contains:
Azithromycin as dihydrate……250mg”
2132. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt.) Limited, Located at plot
Applicant No. E-145 to E-149, North Western Industrial Zone, Port
Qasim, Karachi.
Brand Name +Dosage Form + Strength Brethease 100mcg/6mcg Capsule
Formoterol Fumarate………….6mcg
Budesonide…………………….100mcg
Diary No. Date of R& I & fee Dy.No. 939, 28-10-2013, 20,000/-, 28-10-2013
Pharmacological Group Corticosteroid + selective beta2–adrenergic agonist
Type of Form Form-5
Approval status of product in Reference Symbicort 100/6 Turbohaler, Inhalation Powder by M/s
Regulatory Authorities. AstraZeneca (MHRA Approved)
Me-too status Combivair 100mcg + 6mcg capsule of M/s Highnoon
operating at satisfactory compliance with GMP guidelines.
Previous decision(s) Deferred for product specific inspection by Director DTL
Karachi alongwith FID with following verifications
(M-243):
 Confirmation of approval of formulation by the stringent
regulatory agencies.
 Confirmation of API in ultramicronized form.
Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies adopted by the
Registration Board in 275th meeting (M-289).
Deferred for confirmation of manufacturing and testing facility
for DPI as decided by registration Board in 290th meeting (M-
293).
Evaluation by PEC The firm has submitted copy of product specific inspection
conducted by Director DTL, Karachi and Area FID which
concludes as below:
“In the light of manufacturing, Quality Control, Storage
facilities and technical persons met, the panel is of the view to
recommend Registration of a) Aclidum Capsule, b) Brethease
200mcg/6mcg Capsule, c) Brethease 100mcg/6mcg Capsule, d)
Brethease 400mcg/6mcg Capsule to the firm under the Drug Act,
1976.”
Approval status of applied formulation has been confirmed in
MHRA.
The firm has submitted as under :
 We are using micronized material which is already DPI grade
and hence specialized mixer not require to fine the material

particle size and same is the industrial practice. (Refer to
DRAP panel inspection report & materials CoA’s in Annex 2.1
for details).
 We have separate manufacturing facility for capsules
(General) & capsules (steroidal). With necessary equipment’s,
mean-while a separate dispensing booth for steroidal
dispensing also available. (Refer to DML panel inspection
report in Annex 3.)
 We have revised the finished product specifications and testing
method and include the test of “Uniformity of Delivered Dose”
and “Aerodynamic Particle Size Distribution”. We also
arrange Andersen Cascade Impactor, USP apparatus 1 & 3 for
these tests. Manufactured by Copley Scientific, UK. (Revised
FP specifications, test method and Cascade impactor
qualification documents attached in Annex 4).
 We have Andersen Cascade impactor for determining the
aerodynamic particle size of API in formulation blend in
micron range. United States pharmacopoeia/British
Pharmacopoeia recommend any one of the Marple-miller
impactor, Andersen Impactor, Multistage Liquid Impinger,
Next Generation Impinger etc. (Refer to Annex 1 for details).
 We have mentioned our drug delivery device as CAPSUHALE
in our submitted product specifications. Similarly we also
include target delivery dose in our product specifications.
(Refer to Annex 4.1).
Previous decision (M-295): Registration Board deferred the case for further deliberation in
the light of decision of 290th meeting of Registration Board.
2133. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt.) Limited, Located at plot
Applicant No. E-145 to E-149, North Western Industrial Zone, Port
Qasim, Karachi.
Brand Name +Dosage Form + Strength Brethease 200mcg/6mcg Capsule
Formoterol Fumarate………….6mcg
Budesonide…………………….200mcg
Diary No. Date of R& I & fee Dy.No. 939, 28-10-2013, 20,000/-, 28-10-2013
Pharmacological Group Corticosteroid + selective beta2–adrenergic agonist
Type of Form Form-5
Approval status of product in Reference Symbicort 200/6 Turbohaler, Inhalation Powder by M/s
Regulatory Authorities. AstraZeneca (MHRA Approved)
Me-too status Combivair 200mcg + 6mcg capsule of M/s Highnoon
operating at satisfactory compliance with GMP guidelines.
Previous decision(s) Deferred for product specific inspection by Director DTL
Karachi alongwith FID with following verifications
(M-243):
 Confirmation of approval of formulation by the stringent
regulatory agencies.
 Confirmation of API in ultramicronized form.
Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies adopted by the
Registration Board in 275th meeting (M-289).
Deferred for confirmation of manufacturing and testing facility
for DPI as decided by registration Board in 290th meeting (M-

293).
Evaluation by PEC The firm has submitted copy of product specific inspection
conducted by Director DTL, Karachi and Area FID which
concludes as below:
“In the light of manufacturing, Quality Control, Storage
facilities and technical persons met, the panel is of the view to
recommend Registration of a) Aclidum Capsule, b) Brethease
200mcg/6mcg Capsule, c) Brethease 100mcg/6mcg Capsule, d)
Brethease 400mcg/6mcg Capsule to the firm under the Drug Act,
1976.”
Approval status of applied formulation has been confirmed in
MHRA.
The firm has submitted as under :
 We are using micronized material which is already DPI grade
and hence specialized mixer not require to fine the material
particle size and same is the industrial practice. (Refer to
DRAP panel inspection report & materials CoA’s in Annex 2.1
for details).
 We have separate manufacturing facility for capsules
(General) & capsules (steroidal). With necessary equipment’s,
mean-while a separate dispensing booth for steroidal
dispensing also available. (Refer to DML panel inspection
report in Annex 3.)
 We have revised the finished product specifications and testing
method and include the test of “Uniformity of Delivered Dose”
and “Aerodynamic Particle Size Distribution”. We also
arrange Andersen Cascade Impactor, USP apparatus 1 & 3 for
these tests. Manufactured by Copley Scientific, UK. (Revised
FP specifications, test method and Cascade impactor
qualification documents attached in Annex 4).
 We have Andersen Cascade impactor for determining the
aerodynamic particle size of API in formulation blend in
micron range. United States pharmacopoeia/British
Pharmacopoeia recommend any one of the Marple-miller
impactor, Andersen Impactor, Multistage Liquid Impinger,
Next Generation Impinger etc. (Refer to Annex 1 for details).
We have mentioned our drug delivery device as CAPSUHALE
in our submitted product specifications. Similarly we also
include target delivery dose in our product specifications. (Refer
to Annex 4.1)
Previous decision (295): Registration Board deferred the case for further deliberation in
the light of decision of 290th meeting of Registration Board.
Firm’s response:
 As concerned of manufacturing controls for particle size of blend, we will use DPI grade API & lactose
(Respitose) as an excepient. Therefore, we do not require spiral jet mill/high shear mixer to fine the
material. We have arranged micronized Budesonide, formoterol fumarate and inhalation grade lactose
(Respitose SV003) in our proposed formulation.
 We are also providing our commitment/undertaking for arrangement/purchase of Spiral Jet Mill/high
shear mixer, when our applied products have requirements of particle size reduction in future.
 We have separate manufacturing facility for capsules (General) & capsules (steroidal). Our Steroidal
capsule manufacturing section is also verified by DRAP Officials during their inspections. We also have
separate dispensing booth for dispensing of steroidal API.
 We have Andersen Cascade impactor for determining the aerodynamic particle size of API in
formulation blend in micron range. United States pharmacopoeia/British Pharmacopoeia recommend
any one of the Marple-miller impactor, Andersen Impactor, Multistage Liquid Impinger, Next
Generation Impinger etc.
 We have revised the finished product specifications and testing method and include the test of
“Uniformity of Delivered Dose” and “Aerodynamic Particle Size Distribution”. We also arrange
Andersen Cascade Impactor, USP apparatus 1 & 3 for these tests. Manufactured by Copley Scientific,
UK.
 We have mentioned our drug delivery device as CAPSUHALE in our submitted product specifications.
Similarly, we have also included “target delivery dose” in our product specifications.
Decision: Registration Board deliberated upon submission of firm and decided as under:
i. Approved the applied product considering the fact that the use of micronized DPI grade
APIs does not necessitate the use of Spiral Jet Mill/high shear mixer.
ii. The firm shall include the test of Aerodynamic particle size distribution” in the finished
product specifications to ensure the required particle size of the formulation blend.
iii. Firm shall use micronized DPI grade excipient for the applied product.
iv. Registration letter shall be issued with following label claim:
“Each capsule contains:
Formoterol Fumarate (micronized) ……. 6mcg
Budesonide (micronized) …………….… 200mcg”
2134. Name and address of manufacturer / M/s Surge Laboratories Pvt Ltd, 10-Km Fasisalabad Road,
Applicant Bhikhi, Distt. Sheikhupura.
Brand Name +Dosage Form + Rotem-AT 120 injection
Strength
Artesunate ……. 120mg
Diary No. Date of R& I & fee Dy. No. 1115, 02-05-2017, Rs. 20,000/- (02-05-2017)
Type of Form Form-5
Pack size & Demanded Price 1’s & 5’s; As per PRC
Approval status of product in WHO prequalified formulation
Me-too status Gen-M Injection by M/s Genix Pharma Karachi (Reg#076073)
GMP status Last inspection report dated 09-11-2017.
Previous Remarks of the Evaluator. Firm does not have Dry powder Injection (General) section.
Previous Decision (M-282) Deferred for evidence of approval of required manufacturing
facility i.e. “Dry powder Injection (general)” or Lyophilizer
Firm’s response Firm has submitted section approval letter for “Sterile Dry Powder
Injectable (General).
Evaluation by PEC Firm did not have section approval at the time of submission of
application i.e., 02-05-2017.
th
Decision of 296 meeting: Approved.
2135. Name and address of M/s Surge Laboratories Pvt Ltd, 10-Km Fasisalabad Road,
manufacturer / Applicant Bhikhi, Distt. Sheikhupura.
Strength
Artesunate ……. 30mg
Type of Form Form-5
Me-too status Gen-M Injection by M/s Genix Pharma Karachi (Reg#076072)
Decision of 296th meeting: Approved.
2136. Name and address of M/s Surge Laboratories Pvt Ltd, 10-Km Fasisalabad Road,
manufacturer / Applicant Bhikhi, Distt. Sheikhupura.
Strength
Artesunate ……. 60 mg
Type of Form Form-5
Me-too status Misonate 60mg Injection by M/s Tabros Pharma (Pvt) Ltd.
Karachi (Reg#057719)
2137. Name and address of "M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
manufacturer / Applicant Road, Islamabad"
Brand Name +Dosage Form + Newgaba 100mg Capsule
Strength
Pregabalin…100mg"
Pharmacological Group Anti-epileptics
Type of Form Form-5
Authorities
Me-too status (with strength and Gabica 100mg Capsule by M/s Getz Pharma (Reg#047366)
dosage form)
GMP status Firm has submitted copy of GMP inspection report conducted on 18 &
23-04-2019concluded as under:
“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.”
Previous Remarks of the Finished products specifications have not been submitted.
EvaluatorII
Previous Decision (M-292) Deferred for updated status of GMP of the firm from QA & LT
division. Moreover Board directed the firm to submit Finished products
specifications.
Firm’s response  Firm has submitted copy of GMP certificate issued on the base of
inspection conducted on 23-04-2019.
 Finished product specifications have also been submitted.
2138. Name and address of "M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle, Kahuta
manufacturer / Applicant Road, Islamabad"
Brand Name +Dosage Form + Newgaba 50mg Capsule
Strength
Pregabalin…50mg"
Pharmacological Group Anti-epileptics
Type of Form Form-5
Authorities
Me-too status (with strength and Gabica 50mg Capsule by M/s Getz Pharma (Reg#048725)
dosage form)
GMP status Firm has submitted copy of GMP inspection report conducted on 18 &
23-04-2019 concluded as under:
“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.”
Previous Remarks of the
EvaluatorII
Previous Decision (M-292) Deferred for updated status of GMP of the firm from QA & LT
division. Moreover Board directed the firm to submit Finished products
specifications.
 Finished product specifications have also been submitted.
2139. Name and address of M/s. HiMedic Pharmaceutcals (Pvt) Ltd.0 Lahore
manufacturer / Applicant
Brand Name +Dosage Form + Soclar Drops 50mg/ml
Strength
Cefaclor (as monohydrate)………………50mg
Type of Form Form-5
Pack size & Demanded Price 15ml; Rs. 131.66/-
Approval status of product in Approved in USFDA as suspension dosage form
Authorities
Me-too status (with strength and Slate Drops 50mg/ml of M/s SAMI Pharmaceuticals (Reg.#
dosage form) 075939)
GMP status Last GMP inspection conducted on 09-08-2018
Previous Remarks of the
EvaluatorII
Previous Decision (M-285) Deferred for updated status of GMP of the firm form QA & LT division
as inspection report submitted by firm does not conclude GMP
compliant status.

Decision of 296th meeting: Approved with USP specifications.
2140. Name and address of manufacturer / "M/s Usawa Pharmaceuticals.146 S.I.Z. Risalpur, KPK,
Applicant Pakistan
by
M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205, Industrial
Triangle, Kahuta Road, Islamabad"
Brand Name +Dosage Form + Strength Awatan 2.25g Injection
Piperacillin sodium eq to Piperacillin…2.0g
Tazobactam sodium eq to Tazobactam…0.25g"
Type of Form Form 5
Pack size & Demanded Price As per SRO.1’s Vial.
Approval status of product in Reference ZOSYN® (piperacillin and tazobactam) for Injection
Me-too status 044142; Tazobact 2.25g Injection
M/s Jinnah Pharmaceuticals, Multan manufactured by Lowitt
Pharma, Peshawar .
GMP status 11 & 24-10-2018. Conclusion:
On the basis of findings, panel unanimously decided to
recommend the issuance of GMP certificate.
Remarks of the Evaluator (V)
 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.
Firm’s response  Firm has submitted they have been granted registration of 11
products by contract manufacturing against their 4 sections.
 Copy of contract agreement has also been submitted.
Decision: Approved.
2141. Name and address of manufacturer / "M/s Usawa Pharmaceuticals.146 S.I.Z. Risalpur, KPK,
Applicant by
M/s Global Pharmaceuticals Pvt Ltd Plot # 204-205, Industrial
Triangle, Kahuta Road, Islamabad"
Brand Name +Dosage Form + Strength Awatan 4.5g Injection
Piperacillin sodium eq to Piperacillin…4.0g
Tazobactam sodium eq to Tazobactam…0.5g"
Type of Form Form 5
Pack size & Demanded Price As per SRO.1’s Vial.
Approval status of product in Reference ZOSYN® (piperacillin and tazobactam) for Injection
Me-too status 044143 Tazobact 4.5g Injection
M/s Jinnah Pharmaceuticals, Multan manufactured by Lowitt
Pharma, Peshawar .
GMP status 11 & 24-10-2018. Conclusion:
On the basis of findings, panel unanimously decided to
recommend the issuance of GMP certificate.
Remarks of the Evaluator (V)
 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.
Firm’s response  Firm has submitted they have been granted registration of 11
products by contract manufacturing against their 4 sections.
 Copy of contract agreement has also been submitted.
Decision: Approved.

a. Deferred Cases
2142. Name and address of Applicant M/s Schiwo Pakistan, 11G, Shah Rukh e Alam Colony, Multan
Detail of Drug Sale License Address: 11G, Shah Rukh e Alam Colony, District Multan
Godown: House No. 24/C, Loha Market, Vehari Road, Near Metro
Station, People Colony Multan
License No. 04-361-0171-0926D vaild till: 26.08.2019
Name and address of Manufacturer M/s Asifac Viet Pharma Co. Ltd. 220 Pham The Hein St.,Dist.8, Ho
Chi Minh City, Vietnam
Factory: Raod No. 5, Giang Dien Industrial Zone, Trang Bom Dist.,
Dong Nai.
Name and address of marketing M/s Asifac Viet Pharma Co. Ltd. 220 Pham The Hein St.,Dist.8, Ho
authorization holder Chi Minh City, Vietnam
Factory: Road No. 5, Giang Dien Industrial Zone, Trang Bom Dist.,
Dong Nai.
Diary No. Date of R& I Dy No.23258: 05.07.2018
Fee including differential fee PKR 100,000/-: 05.07.2018

Brand Name +Dosage Form + Asi-Tydox Plus Powder
Strength
Composition Each 1000g Contains:
Doxycycline Hyclate…200g
Finished Product Specification Not provided
Pack size & Demanded Price 1 kg; Rs. 10500/-
Me-too status TYLODOX 100/200 W.S. POWDER. Reg No. 43595
Detail of certificate attached  Legalized copy of FSC issued by Department of Animal Health of
Vietnam valid for two years from 30.07.2018. Only brand name
has been mentioned without label claim.
 Legalized copy of GMP certificate issued by Department of
Animal Health of Vietnam for five years from 23.1.2017.
 Letter of authorization is provided.
Remarks of the Evaluator.  First page of Form 5A was from manufacturer not importer
and had not been signed. The firm submitted revised first
page of Form 5.
 The firm was asked to submit certificate of analysis. The
firm did not submit the same.
 Only brand name has been mentioned without label claim.

 The firm has provided stability summary sheets, wherein
description, identification, loss on drying and assay have
been performed as per Zone IV-A. However, USP general
chapter has mentioned description, identification, assay and
impurities for universdal tests. Furthermore, USP has
mentionedadditional tests for powder as:
“Oral powders should indicate: "For Oral Use Only". Tests that
are considered specific to the type of powders include:
Minimum Fill (755) and volatile content ((731) and (921)).
Minimum Fill (755) has specifications that apply to oral
powders. On the basis of the nature of the article and scientific
criteria, additional tests may apply, including pH in an aqueous
solution, powder fineness, microbial limits, and others.
Previous decision The Board in its 291st meeting deferred the case for:
 Submission of testing method and certificate of analysis.
 Submission of Original legalized and valid FSC with label
claim of the product.
Evaluation by PEC  The firm changed the address in form 5 from “M/s Schiwo
Pakistan. Office No. 10, First Floor, City Plaza, Khanewal
Road, Chowk Rasheedabad, Multan, Punjab” to “M/s
Schiwo Pakistan, 11G, Shah Rukh e Alam Colony, Multan.
 The firm submitted the testing method and CoA.
 The firm submitted Legalized copy of FSC issued by
Department of Animal Health of Vietnam valid for two years
from 26.09.2019.
Previous decision The Board in its 293rd meeting deferred the case for or changing the
address of applicant in Form 5A.
Evaluation by PEC  The firm submitted Rs. 5000/- fee.
Previous decision (M-295) Deferred for following:

meeting.
Remarks of Evaluator Following reference of me-too product has been verified:
“DOXYSIN WATER SOLUBLE POWDER” of M/s UNIVET
PHARMACEUTICALS, RAWALPINDI. (Reg.#033256)
th
Decision of 296 meeting: Approved.
a. New DML /section
M/s Ferozsons Laboratories Ltd. P.O Ferozsons, Amangarh, Nowshera-Khyber Pakhtunkhwa, has been
granted approval for two new tablet sections in 274th meeting of CLB. Now the firm has applied following
products for priority consideration against these two new sections.
2143. Name, address of Applicant / "M/s Ferozsons Laboratories Ltd. P.O Ferozsons, Amangarh,
Marketing Authorization Holder Nowshera-Khyber Pakhtunkhwa"
Name, address of Manufacturing site. "M/s Ferozsons Laboratories Ltd. P.O Ferozsons, Amangarh,
Nowshera-Khyber Pakhtunkhwa"
☐ Importer
The proposed proprietary name / Ertuvia 5mg Tablet
brand name
Strength / concentration of drug of "Each Film Coated Tablet Contains:
Active Pharmaceutical ingredient Ertugliflozin L-Pyroglutamic Acid Eq. to Ertugliflozin…5mg"
(API) per unit
Pharmaceutical form of applied drug Film coated tablet
Pharmacotherapeutic Group of (API) Anti-Diabetic (A10BK04)
Reference to Finished product Inovator’s specification
specifications
Proposed Pack size 10’s, 14’s, 20’s, 28’s & 30’s
The status in reference regulatory Steglatro approved by USFDA
authorities
For generic drugs (me-too status) --
GMP Status of FPP manufacturer GMP certificate issued on the basis of inspection conducted on 25-
01-2019.
Name and address of API M/s Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,
manufacturer. Ltd. Daixi Street, Luoyang Town, Wujin District, Changzhou City,
Jiangsu Province 213105, China
Module-II (Quality Overall Firm has submitted QOS as per WHO QOS –PD template
Summary)
Module-III Drug Substance: --
Stability Studies of Drug Substance Firm has submitted stability data of 3 batches of API at accelerated
(Conditions & duration of Stability and real time conditions of Zone-IVa.
studies)
Module-III Drug Product:
Pharmaceutical Equivalence and CDP studies against the innovator product “Steglatro 5mg tablets”
Comparative Dissolution Profile in three dissolution mediums has been submitted with acceptable
level of f2 results.
Analytical method Firm has submitted analytical method validation data.
validation/verification of product
Stability studies Firm has submitted stability studies data of three batches at both
accelerated and long term conditions
Manufacturer of API M/s Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi Street,
Luoyang Town, Wujin District, Changzhou City, Jiangsu Province 213105, China
API Lot No. ETG20190101
Description of Pack
Alu-Alu blister in unit carton
(Container closure

system)
Frequency Accelerated: 0,1,2, 3,4, 6 (Months)
Batch No ERTab-001 ERTab-001 ERTab-001
The firm has requested for Exemption from On-site Investigation of their submitted stability data of applied
products and provided the following documents in conjunction with the checklist approved by the Registration
Board in its 293rd Meeting:
1. Reference of previous approval of Firm has referred to onsite inspection report of their product “Empagen
applications with stability study tablet 10mg & 25mg”, which was conducted on 25-10-2019, and was
data of the firm (if any) presented in 294th meeting of Registration Board.
Following observations were reported in the report:
 The HPLC software is 21CFR Compliant. \
 Firm has demonstrated audit trail reports of testing.
 The firm has stability chambers for carrying out accelerated and
real time stability studies provided with uninterrupted power supply
and data loggers.
2. Approval of API/ DML/GMP  Copy of GMP certificate (JS20180935) issued by the Jiangsu Drug
certificate of API manufacturer Administration in the name of Shanghai Pharma Group Changzhou
issued by concerned regulatory Kony Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town, Wujin
authority of country of origin. District, Changzhou City, Jiangsu Province 213105, China has been
submitted which is valid upto 26-11-2023.
3. Documents for the procurement Firm has submitted copy of Form issued by ADC DRAP Peshawar
of API with approval from DRAP office dated 26-02-2019 specifying import 189gm Ertugliflozin L-
(in case of import). pyroglutamic acid from M/s Shanghai Pharma Group Changzhou
Kony Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town,
Wujin District, Changzhou City, Jiangsu Province 213105, China
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)
☐ Importer

The proposed proprietary name / Ertuvia 15mg Tablet
brand name
Active Pharmaceutical ingredient Ertugliflozin L-Pyroglutamic Acid Eq. to Ertugliflozin…15mg"
(API) per unit
Pharmacotherapeutic Group of (API) Anti-Diabetic (A10BK04)
Reference to Finished product Inovator’s specification
specifications
The status in reference regulatory Steglatro approved by USFDA
authorities
01-2019.
Summary)
studies)
Pharmaceutical Equivalence and CDP studies against the innovator product “Steglatro 15mg tablets”
Comparative Dissolution Profile in three dissolution mediums has been submitted with acceptable
level of f2 results.
Manufacturer of API M/s Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi Street,
Luoyang Town, Wujin District, Changzhou City, Jiangsu Province 213105, China.
API Lot No. ETG20190101
Description of Pack Alu-Alu blister in unit carton
(Container closure
system)
and data loggers.
2. Approval of API/ DML/GMP  Copy of GMP certificate (JS20180935) issued by the Jiangsu Drug
certificate of API manufacturer Administration in the name of Shanghai Pharma Group Changzhou
issued by concerned regulatory Kony Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town, Wujin
authority of country of origin. District, Changzhou City, Jiangsu Province 213105, China has been
submitted which is valid upto 26-11-2023.
3. Documents for the procurement Firm has submitted copy of Form issued by ADC DRAP Peshawar
of API with approval from DRAP office dated 26-02-2019 specifying import 189gm Ertugliflozin L-
(in case of import). pyroglutamic acid from M/s Shanghai Pharma Group Changzhou
Kony Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town,
Wujin District, Changzhou City, Jiangsu Province 213105, China
data sheets etc.
Remarks of EvaluatorII:
Sr. Section #. Deficiencies
No.
1. 3.2.S.4  Drug substance specifications submitted by the Drug substance
manufacturer include the assay test for the content of “Ertugliflozin-
LPGA”, while the assay test for the content of “Ertugliflozin” shall

have been included as per the available literature of the innovator
product.
 Copies of the Drug substance analytical procedures used for routine
testing of the Drug substance (API) by Drug Product manufacturer is
required.
 Acceptance criteria for the parameter of Accuracy in “Analytical
Method Verification” studies has been declared in terms of “RSD
should not be more than +2%”, instead of the “percentage recovery”.
Justification shall be submitted in this regard.
 Specificity parameter has been performed by injecting the mobile
phase as a blank, sample and reference solution. Whereas USP chapter
<1225> & ICH Q2 (R1) guidelines suggests spiking the drug substance
with appropriate levels of impurities. Justification shall be submitted
for this variation.
 Analytical record for the batch analysis of Drug substance, performed
by the Drug product manufacturer shall be submitted.
2. 3.2.S.5  The submitted Drug substance analytical procedure recommends the
use of working standard of “Ertugliflozin L-pyrogulatmic acid” for
Assay & related substances test, whereas the COA of working standard
of “Ertugliflozin” has been submitted.
P - PART
3. 3.2.P.5.5  Acceptance criteria for the parameter of Accuracy in “Analytical
Method Validation” studies has been declared in terms of “RSD should
not be more than +2%”, instead of the “percentage recovery”.
phase as a blank, placebo, sample and reference solution. Whereas USP
chapter <1225> & ICH Q2 (R1) guidelines suggests spiking the drug
substance with appropriate levels of impurities or exposing the drug
product sample to relevant stress conditions (e.g., light, humidity, acid
or base hydrolysis, oxidation). Justification shall be submitted for this
variation in method.
4. 3.2.P.8  Calculation of Assay results during stability studies has been
performed by using the “theoretical concentration” of the sample
solution instead of the actual concentration based upon the weight of
the drug product sample used to prepare the sample solution.
Decision: Registration Board deferred the applications of Ertuvia 5mg Tablet & Ertuvia 15mg Tablet for
the following deficiencies:
No.
product.
required.

for this variation.
P - PART
☐ Importer
The proposed proprietary name / Ertuvia-S 5/100 mg Tablet
brand name
Active Pharmaceutical ingredient Ertugliflozin L-Pyroglutamic Acid Eq. to Ertugliflozin…….5mg
(API) per unit Sitagliptin Phosphate Monohydrate Eq. to Sitagliptin……100mg"
Pharmacotherapeutic Group of (API) Anti-Diabetic (A10BK04) , (A10BD24)
Reference to Finished product Innovator’s specification
specifications

The status in reference regulatory Steglujan approved by USFDA
authorities
01-2019.
Summary)
studies)
Pharmaceutical Equivalence and CDP studies against the innovator product “Steglujan tablets” in
Comparative Dissolution Profile three dissolution mediums has been submitted with acceptable level
of f2 results.
Manufacturer of API Ertugliflozin L-Pyroglutamic Acid: M/s Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town, Wujin District, Changzhou City,
Jiangsu Province 213105, China.
Sitagliptin Phosphate Monohydrate: M/s Zhejiang Yongtai Pharmaceutical Co., Ltd.
No.1, 4th Donghai Road, Zhejiang Provincial Chemical and Medical Raw Material Base
Linhai Zone, Linhai City, Zhejiang Province, 317016, China
API Lot No. Ertugliflozin L-Pyroglutamic Acid: ETG20190101
Sitagliptin Phosphate Monohydrate: 1827-0001-18079
Description of Pack
(Container closure Alu-Alu blister in unit carton
system)

and data loggers.
2. Approval of API/ DML/GMP Ertugliflozin L-Pyroglutamic Acid: Copy of GMP certificate
certificate of API manufacturer (JS20180935) issued by the Jiangsu Drug Administration in the name of
issued by concerned regulatory Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.
authority of country of origin. Daixi Street, Luoyang Town, Wujin District, Changzhou City, Jiangsu
Province 213105, China has been submitted which is valid upto 26-11-
2023.
Sitagliptin Phosphate Monohydrate: Firm has submitted copy of
Drug Manufacturing License (No. ZHE20020015) for M/s Zhejiang
Yongtai Pharmaceutical Co., Ltd. No.1, 4th Donghai Road, Zhejiang
Provincial Chemical and Medical Raw Material Base Linhai Zone,
Linhai City, Zhejiang Province, 317016, China, issued by Zheijiang
Food & Drug Administration
3. Documents for the procurement Ertugliflozin L-Pyroglutamic Acid: Firm has submitted copy of Form
of API with approval from DRAP issued by ADC DRAP Peshawar office dated 26-02-2019 specifying
(in case of import). import 189gm Ertugliflozin L-pyroglutamic acid from M/s Shanghai
Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi Street,
Luoyang Town, Wujin District, Changzhou City, Jiangsu Province
213105, China
commercial invoice attested by ADC, DRAP Karachi, dated 02-01-2019
for the import of 350 Kg of Sitagliptin phosphate monohydrate.
data sheets etc.
☐ Importer
product
☐ Export sale
The proposed proprietary name / Ertuvia-S 15/100 mg Tablet
brand name
Active Pharmaceutical ingredient Ertugliflozin L-Pyroglutamic Acid Eq. to Ertugliflozin…15mg
(API) per unit Sitagliptin Phosphate Monohydrate Eq. to Sitagliptin…100mg"
Pharmacotherapeutic Group of (API) Anti-Diabetic (A10BK04) , (A10BD24)
Reference to Finished product Innovator’s specification
specifications
The status in reference regulatory Steglujan approved by USFDA
authorities
01-2019.
Summary)
studies)
Pharmaceutical Equivalence and CDP studies against the innovator product “Steglujan tablets” in
Comparative Dissolution Profile three dissolution mediums has been submitted with acceptable level
of f2 results.
Manufacturer of API Ertugliflozin L-Pyroglutamic Acid: M/s Shanghai Pharma Group Changzhou Kony
Pharmaceutical Co., Ltd. Daixi Street, Luoyang Town, Wujin District, Changzhou City,
Jiangsu Province 213105, China.
Sitagliptin Phosphate Monohydrate: M/s Zhejiang Yongtai Pharmaceutical Co., Ltd.
No.1, 4th Donghai Road, Zhejiang Provincial Chemical and Medical Raw Material Base
Linhai Zone, Linhai City, Zhejiang Province, 317016, China
API Lot No. Ertugliflozin L-Pyroglutamic Acid: ETG20190101
Sitagliptin Phosphate Monohydrate: 1827-0001-18079
Description of Pack Alu-Alu blister in unit carton
(Container closure
system)
and data loggers.
2. Approval of API/ DML/GMP Ertugliflozin L-Pyroglutamic Acid: Copy of GMP certificate
certificate of API manufacturer (JS20180935) issued by the Jiangsu Drug Administration in the name of
issued by concerned regulatory Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.
authority of country of origin. Daixi Street, Luoyang Town, Wujin District, Changzhou City, Jiangsu
Province 213105, China has been submitted which is valid upto 26-11-
2023.
Drug Manufacturing License (No. ZHE20020015) for M/s Zhejiang
Yongtai Pharmaceutical Co., Ltd. No.1, 4th Donghai Road, Zhejiang
Provincial Chemical and Medical Raw Material Base Linhai Zone,
Linhai City, Zhejiang Province, 317016, China, issued by Zheijiang
Food & Drug Administration
3. Documents for the procurement Ertugliflozin L-Pyroglutamic Acid: Firm has submitted copy of Form
of API with approval from DRAP issued by ADC DRAP Peshawar office dated 26-02-2019 specifying
(in case of import). import 189gm Ertugliflozin L-pyroglutamic acid from M/s Shanghai
Pharma Group Changzhou Kony Pharmaceutical Co., Ltd. Daixi Street,
Luoyang Town, Wujin District, Changzhou City, Jiangsu Province
213105, China
commercial invoice attested by ADC, DRAP Karachi, dated 02-01-2019
for the import of 350 Kg of Sitagliptin phosphate monohydrate.
data sheets etc.


No.
Ertugliflozin-LPGA
product.
required.
for this variation.
Sitagliptin Phosphate
3. 3.2.S.4  Copies of the Drug substance analytical procedures used for routine
required.
with appropriate levels of impurities or exposing the drug product
sample to relevant stress conditions (e.g., light, humidity, acid or base
hydrolysis, oxidation). Justification shall be submitted for this
variation.
P - PART
Decision: Decision: Registration Board deferred the applications of Ertuvia-S 5/100 mg Tablet & Ertuvia-
S 15/100 mg Tablet for the following deficiencies:

No.
Ertugliflozin-LPGA
product.
required.
for this variation.
Sitagliptin Phosphate
3. 3.2.S.4  Copies of the Drug substance analytical procedures used for routine
required.
with appropriate levels of impurities or exposing the drug product
sample to relevant stress conditions (e.g., light, humidity, acid or base
hydrolysis, oxidation). Justification shall be submitted for this
variation.
P - PART
a. New Cases (Veterinary)
2147. Name and address of Applicant M/s Prix Pharmaceutica, 26 Abbot Road, Lahore, 54000,
Pakistan
Detail of Drug Sale License Address: M/s Prix Pharmaceutica,
26 abbot road Lahore (Godown: Plot NO. 5, Pharmacity, 30Km
Multan Road Lahore.
Validity: 12/06/2022`
Name and address of M/s Fatro S.P.A, Via Emilia, 285-40064, Ozzano Emilia (Bo) Italy.
manufacturer
Name and address of marketing M/s Fatro S.P.A, Via Emilia, 285-40064, Ozzano Emilia (Bo) Italy.
authorization holder
Name of exporting country Italy
Brand Name +Dosage Form + ZOOCOLAGOGO C.M. Oral Powder
Strength
Composition Each 18gm sachet contains:
Rhubarb ……. 9gm
Boldo leaf …….. 6gm
Condurango ……. 2gm
Nux vomica ……. 1gm
Finished Product Specification Manufacturer’s specification
Pharmacological Group Products for alimentary tract and metabolism
Shelf life 5 years
Pack size 1’s
International availability Approved by Italy (Ministry of Health Directorate General for
Animal Health and Veterinary Medicinal Products)
Me-too status N/A
for three batches.
Detail of certificates attached  Original Legalized CoPP
Certificate No: 163/2018/C
Certifying Authority: Ministry of Health Directorate General for
Animal Health and Veterinary Medicinal Products
Free sale in exporting country: Yes
 GMP of manufacturer: Yes
GMP Certificate
The GMP certificate (No. NBF/18/2017/V) issued by Ministry of
Health - General Directorate of Animal Health and Veterinary
Drugs Italy, submitted by the firm and also available at EUDRA
GMP database, valid upto 23-02-2020.
Sole Agency Agreement:
Firm has submitted declaration form M/s Fatro S.P.A, Italy
wherein M/s Prix Pharmaceutica, 26 Abbot Road, Lahore,
54000, Pakistan has been declared as sole agent in Pakistan
for their product “Zoocolagogo C.M. oral powder”.
Decision: Registration Board deferred the case for following:
i. Opinion from H&OTC division regarding the classification of applied formulation.
ii. Submission of stability data of the applied product as per Zone IV-a conditions.
iii. Submission of valid legalized GMP certificate of the finished product manufacturer.
a. New cases
2148. Name and address of manufacturer M/s Hudson Pharma Pvt. Ltd. D-93 north western industrial
/ Applicant zone, port Qasim, Karachi.
Brand Name +Dosage Form + Jenta 80mg Injection
Strength
Gentamicin as sulphate ….… 80mg
Diary No. Date of R& I & fee Dy.No.728, 27-7-2016, Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 2 ml ampoule As per SRO
Approval status of product in DBL GENTAMICIN 80mg/2mL Injection BP (TGA)
Me-too status GENXAT of Surge pharma
Last GMP Inspection dated 03-04-2019 with conclusive
remarks of acceptable cGMP compliance.
Decision:
Drug Jenta 80mg Injection
Name of Manufacturer M/s Hudson Pharma Pvt. Ltd. D-93 north western industrial zone,
port Qasim, Karachi.
Manufacturer of API M/s Fujian Fukang Pharmaceutical Co., Ltd., Jiangyin Industrial
Estate, Fujian, China
API Lot No. FG 1608226
Description of Pack LDPE Ampoule

Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,1,3,6 months
Real Time: 0,1,3,6 months
Batch No. 001 002 003
Batch Size 20,000 ampoules 20,000 ampoules 20,000 ampoules
No. of Batches 03
1. COA of API
Yes
2. Approval of API by regulatory authority of  Copy of GMP Certificate

country of origin or GMP certificate of API (Certificate#FJ20170003) issued by
manufacturer issued by regulatory authority of Germany, valid upto 09-04-2022
country of origin.
Yes
4. Documents confirming import of API etc. Copy of ADC attested invoice for
Gentamicin sulfate, dated 16-12-2016.
/ documents.
Yes
Yes
Rules, 1978.
i. Firm has submitted data for Bio-Assay analysis as per USP monograph.
ii. Firm has used LDPE ampoules as primary container closure system for applied formulation which is a
semi permeable container. As per ICH guidelines for drug products packaged in semi-permeable containers
the testing conditions are:
Study Storage conditions
Long Term 30°C ± 2°C/35% RH ± 5% RH
Accelerated 40°C ± 2°C/not more than (NMT) 25% RH
iii. The firm has submitted reports of 6 months accelerated & long term stability studies, for all the above
three batches of Jenta 80mg injection, the firm has derived water loss rate by applying alternate approach
given in the ICH Q1A (R2) guidelines as below:

Moreover firm has submitted Container Qualification Studies for Low Density Polyethylene (LDPE), as per
USP. The submitted studies make following declarations:
 Material pass the test describe in European Pharmacopoeia.
 Material pass the test describe in USP.
 LDPELE6609 PH has FDA drug master file number DMF 17927 (24086 ex Porvoo)
 PCSIR test reports for extractable metals concluded that No Extractable was found in LDPE sample
tested as per USP<661.1>.
 Sample analysed as per USP <661.2> and found results within the USP specification.

Decision: Registration Board deliberated the case in detail and considering the submitted stability data
“Container qualification studies”, the Board decided to approve Jenta 80mg injection (Gentamicin)”, of
M/s Hudson Pharma Pvt. Ltd. D-93 north western industrial zone, port Qasim, Karachi.
b. Deferred cases
Sr. No. Name & Address Brand Name Type of Form, International
of Manufacturer / (Proprietary Name Initial Diary & Date, Fee Availability / Local
Applicant + Dosage Form + (including differential fee), Availability
Strength), Demanded Price / Pack
Composition, size GMP Inspection
Pharmacological Report Date &
Group, Remarks
Finished Product
Specification
2149. M/s Helix Pharma Aglizon 10mg Tablet Form-5D FORXIGA
(Pvt.) Ltd., Each film-coated Dy. No: 19554 dapagliflozin (as
Hakimsons House, tablet contains: Dated 30.10.2017 propanediol
A/56, SITE Mangho Dapagliflozin as Rs.50,000/- monohydrate) 10 mg
pir Road Karachi- propapendiol As per SRO (1x10’s, film coated tablets
75700 monohydrate…10mg 2x10’s, 3x10’s) blister pack. TGA
(In-house approved.
specifications) Could not be confirmed
The firm was last

inspected on
10.08.2017, wherein it
was concluded that
"Based on the areas
inspected, the people
met and documents
reviewed of M/s Helix
Pharmaceuticals Pvt.
Ltd Karachi found
satisfactory and
compliant as per cGMP
requirement.”

Drug Aglizon 10mg Tablet
Name of Manufacturer M/s Helix Pharma (Pvt.) Ltd., Hakimsons House, A/56, SITE Mangho pir
Road Karachi-75700
Manufacturer of API Shangai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd., Add:
Daixi Street Luyong Town, Wujin District. Changzhou, Jiangsu, China.
API Lot No. DGF20180101 (MFG DATE: 05.01.2018)
Description of Pack
1x10’s, 2x10’s, 3x10’s in Alu Alu blister
Frequency Accelerated: 0,1,2,3,4 & 6 (months)
Real Time: 0, 3, 6 (months)

Batch No. TF001 TF002 TF003
Batch Size 1000 1000 1000
Manufacturing Date 05.2018 05.2018 05.2018

Date of Initiation 26.05.2018 26.05.2018 26.05.2018
No. of Batches 03
Date of Submission 23.04.2019 (Dy. No. 4341)
No.
1. COA of API
Yes

country of origin or GMP certificate of API Copy of GMP certificate issued by China Food &
manufacturer issued by regulatory authority of Drug Administration, valid upto 18.08.2019.
country of origin.
Yes
Yes
sheets etc.
5. Documents confirming import of API etc. Copy of commercial invoice attested by ADC DRAP
Karachi on 14.05.2018, has been submitted.
(name, sign and stamp) for ensuring Yes (Stamped signature)
Yes
Rules, 1978.
Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
inspection for instant dosage “Ramelton Tablets 8mg”, which was conducted on 18.08.2017,
form conducted during last two and was presented in 273rd meeting of Registration Board.
years. Following observations were reported in the report:
 The HPLC software is 21CFR compliant and having
certificates of Compliance by USFDA
 The firm has audit trail Reports on testing.
 Adequate monitoring and control are available for stability
software.

2. Documents for the procurement  Declaration by WIS Pharmtec Co. Ltd, China
of API with approval from The firm has imported Dapagliflozin API 0.22 kg from
DRAP (in case of import). M/s WIS Pharmtec Co. Ltd, China and the declaration
includes the following information.
Batch No.: DGF20180101
Mfg Date: 05.01.2018
 Details of ADC attested commercial Invoice by
WIS Pharmtec Co. Ltd, China
Invoice No. WIS180047
Quantity imported: 0.22 Kg
Date of import: 28.03.2018
ADC Attestation Date: 14.05.2018
Manufacturer: Shangai Pharma Group Changzhou
Kony Pharmaceutical Co., Ltd., Add: Daixi Street
Luyong Town, Wujin District. Changzhou, Jiangsu,
China.
3. Documents for the procurement No. The firm submitted that these were in minute quantity and free
of reference standard and of cost.
impurity standards.
4. Approval of API/ DML/GMP Firm has provided copy of GMP certificate of M/s Shangai Pharma
certificate of API manufacturer Group Changzhou Kony Pharmaceutical Co., Ltd., Add: Daixi
issued by regulatory authority of Street Luyong Town, Wujin District. Changzhou, China for API
country of origin. valid till 18.08.2019, issued by China FDA.
5. Mechanism for Vendor pre-  The firm has submitted Vendor evaluation Form.
qualification Copy of Vendor Certification Questionnaire filled for M/s Shangai
Pharma Group Changzhou.
6. Certificate of analysis of the API,  Copies of COAs of reference standard and impurity A have
reference standards and impurity been submitted.
standards
7. Documents for the procurement Yes
of excipients used in product
development?
8. List of qualified staff involved in The firm has submitted photocopy of List of three qualified staff
product development with involved in product development. One of them is intermediate
relevant experience. passed, who is assistant officer production
Production Data
9. Authorized Protocols/SOP for The firm has submitted photocopy of following documents for
the development & stability development of FPP:
testing of trial batches. a. Development protocol.
b. Stability Study Protocol.
10. Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Record
record of three stability batches. and Batch Packaging Record of three stability batches for the
stability studies of tablets such as.
Batch No. Date of Mfg. Batch
Size/Yield
TF001 05-2018 1000/992
TF002 05-2018 1000/988
TF003 05-2018 1000/984
11. Record of remaining quantities Batch Size (tablets) Yield Remaining
of stability batches. (tablets) (tablets)
TF001 1000 992 480
TF002 1000 988 540
TF003 1000 984 540
QA / QC DATA
12. Record of Digital data logger for  Yes
13. Method used for analysis of API The firm has applied supplier’s method for analysis of API and has
along with COA. submitted their analytical reports, raw data sheets & relevant
chromatograms.
14. Method used for analysis of FPP  The firm has submitted photocopy of Finished Product
& complete record of testing of specification & Test method.
stability batches (i.e.  Firm has submitted complete record of testing of stability
chromatograms, lab reports, raw batches (i.e. chromatograms, lab reports, raw data sheets etc.)
data sheets etc.)
15. Reports of stability studies of The firm has submitted copies of reports of 06 Months Accelerated
API from manufacturer. and 18 Months Real Time Stability Study (30oC+2 oC, 65+5%)
Data of 03 Batches of API.
The firm has also submitted copies of reports of 06 Months
Accelerated and 24 Months Real Time Stability Study (30oC+2
o
C, 65+5%) Data of 03 Batches of API, wherein impurity A has
not been tested.
16. Analysis reports for excipients The firm has submitted copies of Analytical reports from
used. manufacturers for all excipients used in product development.
17. Drug-excipients compatibility  Not submitted by the firm.
studies. Firm has stated that composition of developed product is similar to
innovator’s product formulation.
18. Record of comparative pH 1.2 0.1N, Acetate buffer 4.5, Phosphate Buffer 6.8.
dissolution data. Feature Reference product
Brand name Forxiga Tab. 10mg
Batch No. NX685
Mfg. date NIL
19. Compliance Record of HPLC Firm has submitted audit trail reports for complete stability studies
software 21CFR & audit trail analysis of three batches.
reports on product testing.
Decision of 293rd meeting: Registration Board decided to defer the case and directed the firm to submit
dissolution testing data with specifications of “NLT Q within 15 minutes” at initial and one month time point
at both accelerated and real time stability conditions for 2 batches.
Evaluation by PEC: Firm has now submitted stability studies of two batches i.e., TF004 & TF 005 for both
accelerated and real time conditions at initial and 01 month time points with revised dissolution specifications
of “NLT 80% within 15 minutes”, along with analytical record i.e., raw data sheets, chromatograms, audit trail
reports.
Decision:
Manufacturer / (Proprietary Name Initial Diary & Date, Fee Availability / Local
Applicant + Dosage Form + (including differential fee), Availability
Strength), Demanded Price / Pack
Composition, size GMP Inspection
Pharmacological Report Date &
Group, Remarks
Finished Product
Specification
2150. M/s Helix Pharma Aglizon 5mg Tablet Form-5D FORXIGA
(Pvt.) Ltd., Dy. No: 19540 dapagliflozin (as

Hakimsons House, Each film-coated Dated 30.10.2017 propanediol
A/56, SITE Mangho tablet Rs.50,000/- (Duplicate monohydrate) 5mg film
pir Road Karachi- contains: dossier) coated tablets blister
75700 Dapagliflozin as As per SRO (1x10’s, pack. TGA approved.
propapendiol 2x10’s, 3x10’s) Could not be confirmed
monohydrate…5mg
(In-house The firm was last
specifications) inspected on
10.08.2017, wherein it
was concluded that
"Based on the areas
inspected, the people
met and documents
reviewed of M/s Helix
Pharmaceuticals Pvt.
Ltd Karachi found
satisfactory and
compliant as per cGMP
requirement.”

Drug Aglizon 5mg Tablet
Name of Manufacturer M/s Helix Pharma (Pvt.) Ltd., Hakimsons House, A/56, SITE Mangho pir
Road Karachi-75700
Manufacturer of API Shangai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd., Add:
Daixi Street Luyong Town, Wujin District. Changzhou, Jiangsu, China.
API Lot No. DGF20180101 (MFG DATE: 05.01.2018)
Description of Pack
Batch No. TF001 TF002 TF003
Batch Size 1000 1000 1000

Date of Initiation 26.05.2018 26.05.2018 26.05.2018
No. of Batches 03
No.
1. COA of API
Yes
2. Approval of API by regulatory authority of Copy of GMP certificate issued by China Food &
country of origin or GMP certificate of API Drug Administration, valid upto 18.08.2019.

manufacturer issued by regulatory authority of
country of origin.
Yes
Yes
sheets etc.
5. Documents confirming import of API etc. Copy of commercial invoice attested by ADC DRAP
Karachi on 14.05.2018, has been submitted.
(name, sign and stamp) for ensuring Yes (Stamped signature)
Yes
Rules, 1978.
Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
inspection for instant dosage “Ramelton Tablets 8mg”, which was conducted on 18.08.2017,
form conducted during last two and was presented in 273rd meeting of Registration Board.
years. Following observations were reported in the report:
 The HPLC software is 21CFR compliant and having
certificates of Compliance by USFDA
 Adequate monitoring and control are available for stability
software.
2. Documents for the procurement  Declaration by WIS Pharmtec Co. Ltd, China
of API with approval from The firm has imported Dapagliflozin API 0.22 kg from
DRAP (in case of import). M/s WIS Pharmtec Co. Ltd, China and the declaration
includes the following information.
Mfg Date: 05.01.2018
 Details of ADC attested commercial Invoice by
WIS Pharmtec Co. Ltd, China
Invoice No. WIS180047
Quantity imported: 0.22 Kg
Manufacturer: Shangai Pharma Group Changzhou
Kony Pharmaceutical Co., Ltd., Add: Daixi Street
Luyong Town, Wujin District. Changzhou, Jiangsu,
China.

of reference standard and
impurity standards.
4. Approval of API/ DML/GMP Firm has provided copy of GMP certificate of M/s Shangai Pharma
certificate of API manufacturer Group Changzhou Kony Pharmaceutical Co., Ltd., Add: Daixi
issued by regulatory authority of Street Luyong Town, Wujin District. Changzhou, China for API
country of origin. valid till 18.08.2019, issued by China FDA.
qualification Copy of Vendor Certification Questionnaire filled for M/s Shangai
Pharma Group Changzhou.
6. Certificate of analysis of the API,  Copies of COAs of reference standard and impurity A have
reference standards and impurity been submitted.
standards
development?
8. List of qualified staff involved in The firm has submitted photocopy of List of three qualified staff
product development with involved in product development. One of them is intermediate
relevant experience. passed, who is assistant officer production
Production Data
9. Authorized Protocols/SOP for The firm has submitted photocopy of following documents for
the development & stability development of FPP:
testing of trial batches. c. Development protocol.
d. Stability Study Protocol.
10. Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Record
record of three stability batches. and Batch Packaging Record of three stability batches for the
stability studies of tablets such as.
Size/Yield
TF001 05-2018 1000/986
TF002 05-2018 1000/990
TF003 05-2018 1000/984
11. Record of remaining quantities Batch Size (tablets) Yield Remaining
of stability batches. (tablets) (tablets)
TF001 1000 986 480
TF002 1000 990 570
TF003 1000 984 540
QA / QC DATA
13. Method used for analysis of API The firm has applied supplier’s method for analysis of API and has
along with COA. submitted their analytical reports, raw data sheets & relevant
chromatograms.
14. Method used for analysis of FPP  The firm has submitted photocopy of Finished Product
& complete record of testing of specification & Test method.
stability batches (i.e.  Firm has submitted complete record of testing of stability
chromatograms, lab reports, raw batches (i.e. chromatograms, lab reports, raw data sheets etc.)
data sheets etc.)
15. Reports of stability studies of The firm has submitted copies of reports of 06 Months Accelerated
API from manufacturer. and 18 Months Real Time Stability Study (30oC+2 oC, 65+5%)
Data of 03 Batches of API.

The firm has also submitted copies of reports of 06 Months
Accelerated and 24 Months Real Time Stability Study (30oC+2
o
C, 65+5%) Data of 03 Batches of API, wherein impurity A has
not been tested.
16. Analysis reports for excipients The firm has submitted copies of Analytical reports from
used. manufacturers for all excipients used in product development.
studies. Firm has stated that composition of developed product is similar to
innovator’s product formulation.
18. Record of comparative pH 1.2 0.1N, Acetate buffer 4.5, Phosphate Buffer 6.8.
dissolution data. Feature Reference product
Brand name Forxiga Tab. 5mg
Batch No. V832F
Mfg. date NIL
19. Compliance Record of HPLC Firm has submitted audit trail reports for complete stability studies
software 21CFR & audit trail analysis of three batches.

The testing/analysis method of API is different 90% Tests inclusive of critical tests, i.e ; Assay,
from that of manufacturer. Justify. Solubility, Related Substance, Clarity, Water
content etc. all are comparative / present in
Helix’s Testing protocols same as supplier.
However, test i.e; particle size is for information
only & residual solvent (OVI) would be
performed in future once the Gas
Chromatography is purchased by Quality
Control department. However, as per COA, the
firm only performed description, identification
water content, residue on ignition and assay with
in-house claims, and the limits are as per
specifications of APi manufacturer.
API FPP
manufacturer manufacturer
Column Agilent Zorbax ODS
Conditio SB-C18 (150mm x
n (240mm x 4.6mm x 5
4.6mm x 5 micron)
micron or
equivalent)
The peaks at approx. 1.19, 1.31, 1.50 and 3.73 The extra small peaks in chromatogram of assay
(RT) are present in the chromatogram of initial sample is due to presence of excipients which
assay, but not in that of standard. Justify/clarify. are used in the formulation whereas no extra
small peak in chromatogram of standard as the
standard contains only pure active ingredient.
The innovator product has time of 15 minutes for We have formulated our applied product
dissolution test as per pharmacology and “Aglizon Tablets (Dapagliflozin)” as film coated
biopharmaceutics review. You have set it 30 tablets & as per USP , disintegration time for
minutes. Justify. film coated tablet is NMT 30 minutes for in-vitro
test. We have performed In-vitro test not in–
vivo.
Tailing factors and theoretical plates are missing The firm did not submit the same.
in the chromatogram of API and finished product
(assay, dissolution and stability data).

In comparative dissolution profile, justify the use Please note that the comparative dissolution
06 tablets instead of 12 tablets, and the peaks in profile (CDP) of newly applied molecules was
the chromatograms of samples, which are not carried out in the past by using 06 units.
present in those of standard. However, we assure you to conduct CDP by
using 12 units each of reference and sample
product in future & for the same we are in-
process to purchase 12 to 14 units dissolution
apparatus.
You have not performed drug-excipients Please note that the Innovator used Talc as
compatibility study by submitting that stated excipient in coating process & in our
composition of developed product is similar to formulation, Talc is used as a Lubricant agent to
innovator’s product formulation. However, you improve the flow property in granulation stage.
have added talc powder in your formulation, This is an inert material which do not have any
which is not used in the innovator’s product. therapeutic effect & is the part of formulation
Justify/clarify. either used in granulation or coating process.
We are enclosing herewith the reference page
from Handbook of Pharmaceutical Excipients
for Role of Talc for your ready reference in
Annex – X.
Decision of 293rd meeting: Registration Board decided to defer the case and directed the firm to submit
dissolution testing data with specifications of “NLT Q within 15 minutes” at initial and one month time point
at both accelerated and real time stability conditions for 2 batches.
Evaluation by PEC: Firm has submitted stability studies of two batches i.e., TF004 & TF 005 for both
accelerated and real time conditions at initial and 01 month time points with revised dissolution specifications
of “NLT 80% within 15 minutes”, along with analytical record i.e., raw data sheets, chromatograms, audit trail
reports.
Decision: Registration Board decided to approve registration of “Aglizon 5mg Tablet (Dapagliflozin
5mg) and Aglizon 10mg Tablet (Dapagliflozin 10mg) by M/s Helix Pharma (Pvt.) Ltd., Hakimsons House,
A/56, SITE Mangho pir Road Karachi-75700. Manufacturer will place first three commercial batches of
both products on long term stability studies throughout proposed shelf life and on accelerated studies for
six months as per Zone-IVA conditions.
Manufacturer / (Proprietary Name Initial Diary & Date, Availability / Local
Applicant + Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / Pack GMP Inspection
Pharmacological size Report Date &
Group, Remarks
Finished Product
Specification
2151. M/s Jenner Etory Tablet 90mg Form-5 Etoricoxib 30 mg, 60
Pharmaceuticals (Pvt.) Each film-coated Dy. No: 15706 Dated mg, 90 mg and 120 mg,
Ltd., 26-km Lahore- tablet 07.03.2018 Rs.20,000/- film-coated tablets.
Sharaqpur Road contains: As per SRO (10’s, 20’s, MHRA approved.
Sheikhupura Etoricoxib…90mg 30’s)
(Innovator’s The firm was inspected
specifications) on 06.11.2017,
Conclusion:
“Overall the condition
of the firm is
satisfactory regarding
to building, equipment
and functioning of
HVAC system.
However they were

advised to improve
their documentation
regarding the
production and quality
control they agreed.”

Drug Etory Tablet 90mg
Name of Manufacturer M/s Jenner Pharmaceuticals (Pvt.) Ltd., 26-km Lahore-Sharaqpur Road
Sheikhupura
Manufacturer of API Kekule Pharma Limited, MIA, Khazaipally, Jinnaran Mandal,
Sangaredddy – 502 319, T. S. India
API Lot No. ACE 01319 (MFG DATE: January, 2018)
Description of Pack
Batch No. ETR-PB-010001 ETR-PB-010002 ETR-PB-010003
Batch Size 1000 1000 1000

Date of Initiation 07.03.2019 (from 07.03.2019 (from initial 07.03.2019 (from
initial analysis) analysis) initial analysis)
No. of Batches 03
1. COA of API
Yes

country of origin or GMP certificate of API Copy of GMP certificate issued by DCA,
manufacturer issued by regulatory authority Government of Telangana valid upto 11.05.2019.
of country of origin.
3. Protocols followed for conduction of
Yes
stability study and details of tests.
Yes
sheets etc.
5. Documents confirming import of API etc. Copy of commercial invoice attested by AD DRAP
Lahore on 30.01.2019, has been submitted.
(name, sign and stamp) for ensuring Yes (Stamped only)

Yes
Rules, 1978.
its 278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product “Lansodex
inspection for instant dosage form capsule 30mg and 60mg, Sofos Tablet 400/90mg and 400mg”, which was
conducted during last two years. conducted on 10.02.2018, and was presented in 287th meeting of
Registration Board.
 The HPLC software is 21CFR compliant and having certificates of
Compliance by USFDA
 Adequate monitoring and control are available for stability chamber.
Chambers are controlled and monitored through software.
2. Documents for the procurement The firm has imported Etoricoxib API 25 kg from
of API with approval from DRAP Kekule Pharma Limited, MIA, Khazaipally, Jinnaran
(in case of import). Mandal, Sangaredddy – 502 319, T. S. India and the
declaration includes the following information.
Batch No.: ACE 01319
Mfg Date: January, 2018
 Details of ADC attested commercial Invoice
Invoice No. KPLEXP/156/18-19
Quantity imported: 25 Kg
Manufacturer: NOT MENTIONED
3. Documents for the procurement No. but CoA of working standard, impurity I and impurity II are attached
impurity standards.
4. Approval of API/ DML/GMP Firm has provided copy of GMP certificate of M/s Kekule Pharma
certificate of API manufacturer Limited, MIA, Khazaipally, Jinnaran Mandal, Sangaredddy – 502 319, T.
issued by regulatory authority of S. India issued by DCA, Government of Telangana valid upto
country of origin. 11.05.2019.
qualification Copy of Vendor Certification Questionnaire filled for M/s Kekule Pharma
Limited, India.
6. Certificate of analysis of the API,  Copies of COAs of API, working standard and impurity-I and
reference standards and impurity impurity-II have been submitted.
standards
development?
8. List of qualified staff involved in The firm has submitted list of three qualified staff involved in product
product development with development.
relevant experience.
Production Data

9. Authorized Protocols/SOP for the The firm has submitted photocopy of following documents for
development & stability testing of development of FPP:
trial batches. a. Development protocol.
10. Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Record and
record of three stability batches. Batch Packaging Record of three stability batches for the stability studies
of tablets such as.
Size/Yield
ETR-PB-010002 02-2019 1000/790
ETR-PB-010001 02-2019 1000/806
ETR-PB-010002 02-2019 1000/984
11. Record of remaining quantities of Batch Size (tablets) Yield Remaining
stability batches. (tablets) (tablets)
ETR-PB- 1000 790 430
010002
ETR-PB- 1000 806 440
010001
ETR-PB- 1000 984 430
010002
QA / QC DATA
13. Method used for analysis of API The firm has referred to analytical method of the API manufacturer.
along with COA.
14. Method used for analysis of FPP  Only method for dissolution and HPLC assay.
& complete record of testing of  Firm has submitted complete record of testing of stability batches (i.e.
stability batches (i.e. chromatograms, lab reports, raw data sheets etc.)
chromatograms, lab reports, raw
data sheets etc.)
15. Reports of stability studies of API
The firm has also submitted copies of reports of 06 Months Accelerated
from manufacturer. and 36 Months Real Time Stability Study (30oC+2 oC, 75+5%) Data of 03
Batches of API, wherein impurity I and II have not been tested
specifically.
16. Analysis reports for excipients The firm has submitted copies of Analytical reports from manufacturers
used. for all excipients used in product development.
studies. Firm has stated that composition of developed product is qualitatively
similar to innovator’s product formulation.
18. Record of comparative pH 1.2 (0.1N HCl), Acetate buffer pH 4.5, Phosphate Buffer pH 6.8 on 06
dissolution data. units. Proof of availability of the product in reference regulatory
authorities as defined in 275th meeting of the registration board is
required.
Feature Reference product
Brand name Etoricoxib Tablet 90mg
Batch No. 1805005040
Exp. date 02.2020
19. Compliance Record of HPLC Yes

The reference product has the criterion for the In Public Assessment Report of Etoricoxib, it is
dissolution test of more than 85% drug release mentioned that release in 0.1N HCl, pH 1.2 is
in 15 minutes. You have set it 80% in 30 faster i.e more than 85% in 15 minutes and
minutes. Justify. slower in acetate buffer pH 4.5 and phosphate
buffer pH 6.8
As per PAR 85% are results, not limits.
Conclusion: Etory tablets 90mg and 120mg are
released more than 85% in 15 minutes at pH 1.2
and more than 95% in 30 minutes (both sample
and reference products) and slower in acetate
buffer pH 4.5 and Phosphate buffer pH 6.8, f2
values are well above 50% . In case of drug
release less than 85% in 15 minutes, the CDP
shall be applied on the drug release data to the
extent of one point above the >85% release, not
at all points
Specify the exact polymorphic form of API Polymorphic Form-1 of API (Etoricoxib) is
used in the drug product. used. Declaration from manufacturer is
attached. (No document specifies that Form-I
has been used).
Justify the selection of dissolution parameters Since innovator brands (Arcoxia 120mg by
for the drug product. Frosst Iberica, Spain and Etoricoxib 90mg by
Torrent Pharma, UK) and our products Etory
Tablets 90mg and Etory Tablets 120mg releases
more than 85% in 15 minutes and more than 95%
in 30 minutes for both sample and reference
products (0.1N HCl, pH 1.2), hence we selected
up to 30 minutes for dissolution of our product.
Note: Dissolution is slower in acetate buffer pH
4.5 and Phosphate buffer pH 6.8.
The reference product contains Avicel PH 101 We use Arcoxia Tablets (Merck Sharp & Dohme
and Avicel PH 200 LM; however, you have Limited UK) as innovator brand and used
used Avicel PH 102 in your formulation and excipients same to this brand.
have imported Comprecel M 102. Moreover, - Since we used excipients similar to innovator,
you have not conducted drug-excipient hence Drug-Excipient compatibility studies is
compatibility studies. Clarify/justify. not required. However, we performed Drug-
Excipient compatibility studies by using FTIR
and literature survey is also attached.
You have not performed all the tests specified Only heavy metals test was missing, now its
by the CoA of API manufacturer. Justify reagents and apparatus is arranged and test is
performed (Report attached)
You have not adjusted the potency of the API Potency of API was not adjusted due to pilot
(assay = 99.51%) in the drug product. batch for R & D, in commercial batches potency
will be adjusted.
The batch of API used in the manufacturing of QC No. is mentioned on BMR, this QC report of
the drug product has not been mentioned in the API contains all traceable data for API including
BMR. Justify. batch no of API. Now, lot No. of API is
mentioned on manufacturing order of BMR.
The humidity graph for accelerated stability Level of water in reservoir was decreased, due to
chamber, on 08.05.2019 and 09.05.2019 shows which humidity was decreased from 70% to
out of limit trends. Justification shall be 60%. Problem was rectified.
submitted.

As you have performed forced degradation Forced degradation study is performed according
studies of the drug product. Reference shall be to Pharmaceutical manufacturing hand book
provided to the guidelines adopted for the Pages 566, 571.
performance of forced degradation studies of The firm submitted that in specificity of AMV
the drug product and specificity test in the report, now this is mentioned that there is no
analytical method validation along with data effect of degradation products. Although not
logger record. detected, the two impurities have RT of 1.65 min
and 2.68 min, while the drug substance has RT
of 3.37.
The values for tailing factor are missing in all Tailing factor value was not selected in report
the chromatograms of the dossier. format, now it is added in report format and few
sample graphs are attached.
You have specified impurity I and II for the These impurities were supplied by manufacturer
API. However, these impurities are not on our demand for additional test, so they
specifically tested in CoA provided by the drug provided. They claimed that these impurities are
substance manufacturer. not present in API, so they are not performing
this test.
The reference product is tested in terms of - Related substances test performed and report
description, identification, colour, average attached with impurities report of “not detected”.
weight, dissolution, uniformity of dosage units - Loss on drying test performed. However, the
by mass variation, related substances, assay, testing method is not provided.
water content, residual solvents and microbial - The firm submitted that the Microbial test
quality. You have not tested the related performed (analyzed in sister concern
substances, water content, residual solvents and company McOlson), report attached.
microbial quality of the drug product. Clarify. However, the testing method is not provided.
- Residual solvent analysis not performed due to
non-availability of GC
Provide CDP data for all three physiological The firm submitted CDP data acquired after
buffers, i.e., 0.1N HCl pH 1.2, Acetate buffer communication of shortcomings letter. release, not at
pH 4.5, Phosphate Buffer pH 6.8. all points. The firm has performed dissolution on 06
tablet, wherein CV (%) of drug release is ca. 18% and
23% for acetate and phosphate buffers at 15 minutes
for the trial batch, i.e., more than 10%. Moreover, in
case of drug release less than 85% in 15 minutes, the
CDP shall be applied on the drug release data to the
extent of one point above the >85%.
Decision of 293rd meeting: Registration Board decided to defer the case and directed the firm to submit dissolution
testing data with specifications of “NLT Q within 15 minutes” at initial and one month time point at both accelerated
and real time stability conditions for 2 batches.
Sr. Name & Address of Brand Name Type of Form, International
No. Manufacturer / (Proprietary Name Initial Diary & Date, Availability / Local
Applicant + Dosage Form + Fee (including Availability
Strength), differential fee),
Composition, Demanded Price / Pack GMP Inspection
Pharmacological size Report Date &
Group, Remarks
Finished Product
Specification
2152. M/s Jenner Etory Tablet 120mg Form-5 Etoricoxib 30 mg, 60
Pharmaceuticals (Pvt.) Each film-coated Dy. No 15707 dated 07- mg, 90 mg and 120 mg,
Ltd., 26-km Lahore- tablet 03-2019 Rs20,000/- film-coated tablets.
Sharaqpur Road contains: Dated 06-03-2019As per MHRA approved.
Sheikhupura Etoricoxib…..120m SRO (10’s, 20’s, 30’s)
g The firm was inspected
(Innovator’s on 06.11.2017,
specifications) Conclusion:
“Overall the condition

of the firm is
satisfactory regarding
to building, equipment
and functioning of
HVAC system.
However they were
advised to improve
their documentation
regarding the
production and quality
control they agreed.”

Drug Etory Tablet 120mg
Name of Manufacturer M/s Jenner Pharmaceuticals (Pvt.) Ltd., 26-km Lahore-Sharaqpur Road
Sheikhupura
Manufacturer of API Kekule Pharma Limited, MIA, Khazaipally, Jinnaran Mandal,
Sangaredddy – 502 319, T. S. India
API Lot No. ACE 01319 (MFG DATE: January, 2018)
Description of Pack
Batch No. ETR-PB-010001 ETR-PB-010002 ETR-PB-010003
Batch Size 1000 1000 1000

Date of Initiation 07.03.2019 (from 07.03.2019 (from initial 07.03.2019 (from
initial analysis) analysis) initial analysis)
No. of Batches 03
1. COA of API
Yes

country of origin or GMP certificate of API Copy of GMP certificate issued by DCA,
manufacturer issued by regulatory authority Government of Telangana valid upto 11.05.2019.
of country of origin.
3. Protocols followed for conduction of
Yes
stability study and details of tests.
Yes
sheets etc.

5. Documents confirming import of API etc. Copy of commercial invoice attested by AD DRAP
Lahore on 30.01.2019, has been submitted.
(name, sign and stamp) for ensuring Yes (Stamped only)
Yes
Rules, 1978.
its 278th Meeting:
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product “Lansodex
inspection for instant dosage form capsule 30mg and 60mg, Sofos Tablet 400/90mg and 400mg”, which was
conducted during last two years. conducted on 10.02.2018, and was presented in 287th meeting of
Registration Board.
 The HPLC software is 21CFR compliant and having certificates of
Compliance by USFDA
 Adequate monitoring and control are available for stability chamber.
Chambers are controlled and monitored through software.
2. Documents for the procurement The firm has imported Etoricoxib API 25 kg from
of API with approval from DRAP Kekule Pharma Limited, MIA, Khazaipally, Jinnaran
(in case of import). Mandal, Sangaredddy – 502 319, T. S. India and the
declaration includes the following information.
Mfg Date: January, 2018
 Details of ADC attested commercial Invoice
Invoice No. KPLEXP/156/18-19
Quantity imported: 25 Kg
Manufacturer: NOT MENTIONED
3. Documents for the procurement No. but CoA of working standard, impurity I and impurity II are attached
impurity standards.
4. Approval of API/ DML/GMP Firm has provided copy of GMP certificate of M/s Kekule Pharma
certificate of API manufacturer Limited, MIA, Khazaipally, Jinnaran Mandal, Sangaredddy – 502 319, T.
issued by regulatory authority of S. India issued by DCA, Government of Telangana valid upto
country of origin. 11.05.2019.
qualification Copy of Vendor Certification Questionnaire filled for M/s Kekule Pharma
Limited, India.
6. Certificate of analysis of the API,  Copies of COAs of API, working standard and impurity-I and
reference standards and impurity impurity-II have been submitted.
standards

development?
8. List of qualified staff involved in The firm has submitted list of three qualified staff involved in product
product development with development.
relevant experience.
Production Data
9. Authorized Protocols/SOP for the The firm has submitted photocopy of following documents for
development & stability testing of development of FPP:
trial batches. a. Development protocol.
10. Complete batch manufacturing The firm has submitted photocopy of Batch Manufacturing Record and
record of three stability batches. Batch Packaging Record of three stability batches for the stability studies
of tablets such as.
Size/Yield
ETR-PB-010002 02-2019 1000/790
ETR-PB-010001 02-2019 1000/806
ETR-PB-010002 02-2019 1000/984
11. Record of remaining quantities of Batch Size (tablets) Yield Remaining
stability batches. (tablets) (tablets)
ETR-PB- 1000 790 430
010002
ETR-PB- 1000 806 440
010001
ETR-PB- 1000 984 430
010002
QA / QC DATA
13. Method used for analysis of API No, only method for HPLC assay.
along with COA.
14. Method used for analysis of FPP  Only method for dissolution and HPLC assay.
& complete record of testing of  Firm has submitted complete record of testing of stability batches (i.e.
stability batches (i.e. chromatograms, lab reports, raw data sheets etc.)
chromatograms, lab reports, raw
data sheets etc.)
15. Reports of stability studies of API
The firm has also submitted copies of reports of 06 Months Accelerated
from manufacturer. and 36 Months Real Time Stability Study (30oC+2 oC, 75+5%) Data of 03
Batches of API, wherein impurity I and II have not been tested
specifically.
16. Analysis reports for excipients The firm has submitted copies of Analytical reports from manufacturers
used. for all excipients used in product development.
studies. Firm has stated that composition of developed product is qualitatively
similar to innovator’s product formulation.
18. Record of comparative pH 1.2 (0.1N HCl), Acetate buffer pH 4.5, Phosphate Buffer pH 6.8 on 06
dissolution data. units. Proof of availability of the product in reference regulatory
authorities as defined in 275th meeting of the registration board is
required.
Feature Reference product

Brand name Arcoxia tablet 120mg
Batch No. 1805005040
Exp. date 02.2020
19. Compliance Record of HPLC Yes
The reference product has the criterion for the In Public Assessment Report of Etoricoxib, it is mentioned
dissolution test of more than 85% drug release that release in 0.1N HCl, pH 1.2 is faster i.e more than 85%
in 15 minutes. You have set it 80% in 30 in 15 minutes and slower in acetate buffer pH 4.5 and
minutes. Justify. phosphate buffer pH 6.8
As per PAR 85% are results, not limits.
Conclusion: Etory tablets 90mg and 120mg are released
more than 85% in 15 minutes at pH 1.2 and more than 95%
in 30 minutes (both sample and reference products) and
slower in acetate buffer pH 4.5 and Phosphate buffer pH 6.8,
f2 values are well above 50% . In case of drug release less
than 85% in 15 minutes, the CDP shall be applied on the
drug release data to the extent of one point above the >85%
release, not at all points
Specify the exact polymorphic form of API Polymorphic Form-1 of API (Etoricoxib) is used.
used in the drug product. Declaration from manufacturer is attached. (No document
specifies that Form-I has been used).
Justify the selection of dissolution parameters Since innovator brands (Arcoxia 120mg by Frosst Iberica,
for the drug product. Spain and Etoricoxib 90mg by Torrent Pharma, UK) and our
products Etory Tablets 90mg and Etory Tablets 120mg
releases more than 85% in 15 minutes and more than 95%
in 30 minutes for both sample and reference products (0.1N
HCl, pH 1.2), hence we selected up to 30 minutes for
dissolution of our product.
Note: Dissolution is slower in acetate buffer pH 4.5 and
Phosphate buffer pH 6.8.
The reference product contains Avicel PH 101 We use Arcoxia Tablets (Merck Sharp & Dohme Limited
and Avicel PH 200 LM; however, you have UK) as innovator brand and used excipients same to this
used Avicel PH 102 in your formulation and brand.
have imported Comprecel M 102. Moreover, - Since we used excipients similar to innovator, hence Drug-
you have not conducted drug-excipient Excipient compatibility studies is not required. However,
compatibility studies. Clarify/justify. we performed Drug-Excipient compatibility studies by
using FTIR and literature survey is also attached.
You have not performed all the tests specified Only heavy metals test was missing, now its reagents and
by the CoA of API manufacturer. Justify apparatus is arranged and test is performed (Report
attached)
You have not adjusted the potency of the API Potency of API was not adjusted due to pilot batch for R &
(assay = 99.51%) in the drug product. D, in commercial batches potency will be adjusted.
The batch of API used in the manufacturing of QC No. is mentioned on BMR, this QC report of API
the drug product has not been mentioned in the contains all traceable data for API including batch no of
BMR. Justify. API. Now, lot No. of API is mentioned on manufacturing
order of BMR.
The humidity graph for accelerated stability Level of water in reservoir was decreased, due to which
chamber, on 08.05.2019 and 09.05.2019 shows humidity was decreased from 70% to 60%. Problem was
out of limit trends. Justification shall be rectified.
submitted.

As you have performed forced degradation Forced degradation study is performed according to
studies of the drug product. Reference shall be Pharmaceutical manufacturing hand book Pages 566, 571.
provided to the guidelines adopted for the The firm submitted that in specificity of AMV report, now
performance of forced degradation studies of this is mentioned that there is no effect of degradation
the drug product and specificity test in the products. Although not detected, the two impurities have RT
analytical method validation along with data of 1.65 min and 2.68 min, while the drug substance has RT
logger record. of 3.37.
The values for tailing factor are missing in all Tailing factor value was not selected in report format, now
the chromatograms of the dossier. it is added in report format and few sample graphs are
attached.
You have specified impurity I and II for the These impurities were supplied by manufacturer on our
API. However, these impurities are not demand for additional test, so they provided. They claimed
specifically tested in CoA provided by the drug that these impurities are not present in API, so they are not
substance manufacturer. performing this test.
The reference product is tested in terms of - Related substances test performed and report attached with
description, identification, colour, average impurities report of “not detected”.
weight, dissolution, uniformity of dosage units - Loss on drying test performed. However, the testing
by mass variation, related substances, assay, method is not provided.
water content, residual solvents and microbial - The firm submitted that the Microbial test performed
quality. You have not tested the related (analyzed in sister concern company McOlson), report
substances, water content, residual solvents and attached. However, the testing method is not provided.
microbial quality of the drug product. Clarify. - Residual solvent analysis not performed due to non-
availability of GC
Provide CDP data for all three physiological The firm submitted CDP data acquired after communication of
buffers, i.e., 0.1N HCl pH 1.2, Acetate buffer shortcomings letter. release, not at all points. The firm has
pH 4.5, Phosphate Buffer pH 6.8. performed dissolution on 06 tablet, wherein CV (%) of drug
release is ca. 18% and 23% for acetate and phosphate buffers at 15
minutes for the trial batch, i.e., more than 10%. Moreover, in case
of drug release less than 85% in 15 minutes, the CDP shall be
applied on the drug release data to the extent of one point above
the >85%.
Decision of 293rd meeting: Registration Board decided to defer the case and directed the firm to submit dissolution
testing data with specifications of “NLT Q within 15 minutes” at initial and one month time point at both accelerated
and real time stability conditions for 2 batches.

Response by Firm: Firm has submitted stability studies at both accelerated and long term conditions with revised
specifications of Dissolution i.e., “NLT 85% within 15 minutes” at initial and one month time point.
Details are as follows:
Etory 90 mg tablet:
Storage
Test Performed Specifications Batch No. Initial 01 Month
Conditions
ETR-TB-
95.75% 96.26%
Accelerated 010001
Dissolution Test NLT 85% of
(40±2 0C, 75±5%
(at 15 minutes) label claim
RH) ETR-TB-
95.57% 97.96%
010002
ETR-TB-
Real Time 95.75% 99.27%
Dissolution Test NLT 85% of 010001
(30±2 0C, 65±5%
(at 15 minutes) label claim ETR-TB-
RH) 95.57% 98.81%
010002
Etory 120mg tablet
Test
Storage Conditions Specifications Batch No. Initial 01 Month
Performed
ETR-TB-
Dissolution 100.17% 100.82%
Accelerated 011001
Test NLT 85% of
(40±2 0C, 75±5%
(at 15 label claim
RH) ETR-TB-
minutes) 100.16% 99.43%
011002
Dissolution ETR-TB-
Real Time 100.17% 100.06%
Test NLT 85% of 011001
(30±2 0C, 65±5%
(at 15 label claim ETR-TB-
RH) 100.16% 100.55%
minutes) 011002
Decision: Registration Board decided to approve registration of “Etory Tablet 90mg (Etoricoxib) and Etory
Tablet 120mg (Etoricoxib) by M/s Jenner Pharmaceuticals (Pvt.) Ltd., 26-km Lahore-Sharaqpur Road
Sheikhupura. Manufacturer will place first three commercial batches of both products on long term stability
studies throughout proposed shelf life and on accelerated studies for six months as per Zone-IVa conditions.
Sr. Name & Address Brand Name Type of Form, International

No. of Manufacturer / (Proprietary Name + Initial Diary & Date, Fee Availability / Local
Applicant Dosage Form + Strength), (including differential Availability
Composition, fee),
Pharmacological Group, Demanded Price / Pack GMP Inspection Report
Finished Product size Date & Remarks
Specification
2153. M/s. Macter Vireof-N 25mg Tablets. Duplicate dossier Approved in US-FDA
International Each film coated tablet
Limited, F-216, contains: The firm was granted
S.I.T.E, Karachi. Tenofovir alafenamide (as GMP certificate based on
fumarate)… 25mg inspection conducted on
14-03-2017.

Drug Vireof-N 25mg Tablets.

Name of Manufacturer M/s. Macter International Limited, F-216, S.I.T.E, Karachi
Manufacturer of API Shengai Desano Chemical Pharmaceuticals,
No. 417, Binhai Road, Laogang Town, Pudong New Area, Shanghai.
API Lot No. DBH251-B15A-180802

Description of Pack
Alu/alu blister
Frequency Accelerated: 0,1, 3,6 (month)
Real Time: 0,1, 3,6 (month)
Batch No. 001P 002P 003P

Date of Initiation Sep- 2018 Sep- 2018 Sep- 2018
No. of Batches 03
Date of Submission 15-04-19 (Dy. No. 3603)
No.
1. COA of API Applicant has submitted the following:
Copy of COA
From:Shengai Desano Chemical PharmaceuticalsBatch
No: DBH251-B15A-180802
country of origin or GMP certificate of API Applicant has submitted the following:
manufacturer issued by regulatory authority of Copy of GMP Certificate:
country of origin. Certificate No: SH2017046
Issued To: Shengai Desano Chemical Pharmaceuticals,
No. 417, Binhai Road, Laogang Town, Pudong New Area,
Shanghai.
Issued ON: 04-12-2017
Valid Till: 3-12-2022
Issued By: China Food & Drug Administration.

Yes
5. Documents confirming import of API etc. Applicant has submitted Coy of Commercial invoice
attested by ADC on 27-08-18 having following
information on it:
Invoice Number: DL-Y-2018-0208
Manufacturer of API: Desano Limited. No. 1479,
Zhangheng Road, Zhangliang Hi- Tech Park, Shanghai
201203, China.
Tenofovir Alafenamide Fumarate API: 1kg
Tenofovir Alafenamide Fumarate API W/S: 4g

Impurity 1: 100mg
Fumaric acid: 100mg
Impurity 2: 100mg

/ documents.
7. Commitment to continue real time stability study
Yes
8. Commitment to follow Drug Specification Rules,
Yes
1978.
Evaluation by PEC:
Report on Investigation of Authenticity / Genuineness of data submitted for registration of Vireof-N Tablet 25mg
(TenofovirAlafenamide Fumarate) Tablets by M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.
Reference No: F.13-11/2017-PEC (Pt) dated 14th Nov, 2019.

Investigation Date and Time: 18th December, 2019.
Investigation Site: M/s. Macter International Ltd., F-216, S.I.T.E, Karachi.
Background:
Chairman Registration Board considered the applications of M/s. Macter International Ltd., F-216, S.I.T.E,
Karachi for registration of Vireof-N Tablet 25mg (Tenofovir Alafenamide Fumarate) Tablets. PE&R Division
considered scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration being new
formulation and constituted a three member panel to investigate the authenticity / genuineness of data (import of raw
material and stability data). Panel was advised to conduct inspection of the firm and also advised to verify:
“Confirmation of dissolution test results for all trial batches of applied formulation on US-FDA recommended
dissolution parameters including RPM”.
1. Prof. Dr. Ghulam Sarwar, ex-member Registration Board, Dean faculty of Pharmacy, Jinnah University
for Women, Karachi.
2. Dr. Affan Ali Qureshi, Assistant Director (CDL) DRAP, Karachi.
3. Dr. Kirshan Das, Assistant Director DRAP Karachi.
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.

The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also audited.
The details of investigation may be summarized as under:
Detail of Investigation:

S. No. Question Observation
1. Do you have documents confirming the The firm has imported 1Kg Tenofovir Alafenamide
import of Tenofovir Alafenamide Fumarate Fumarate (API) from Shanghai Desano Chemical
API including approval from DRAP? Pharmaceutical Co., Ltd.)vide invoice No. DL-Y-2018-
0208 dated: 27.08. 2018. There is proper approval from
DRAP Karachi Form 6 (2440-17).
2. What was the rationale behind selecting the The rationale behind selecting the particular manufacturer
particular manufacturer of API? of API is the vendor evaluation process based on audit and
other criteria like manufacturer GMP status, DMF source
etc.
3. Do you have documents confirming the The firm has imported Tenofovir Alafenamide Fumarate
import of Tenofovir Alafenamide Fumarate working standard and two impurities standards from the
reference standard and impurity standards? API manufacturer.
4. Do you have certificate of Analysis of the The firm has Certificate of Analysis of API, working
API, reference standards and impurity standard of API and impurities standards.
standards?
5. Do you have GMP certificate of API The firm has GMP certificates for API manufacturer issued
manufacturer issued by regulatory authority by China Food & Drugs Administration valid till
of country of origin? 03/12/2022.
6. Do you use API manufacturer method of The firm has used API manufacturer method of testing.
testing for testing API?
7. Do you have stability studies reports on The firm has stability studies report on API (Tenofovir
APIs? Alafenamide Fumarate) conducted by API manufacturer.
8. If yes, whether the stability testing has been The manufacturer of API has performed the stability studies
performed as per SIM method and as per SIM method. The process related impurities and
de

Minutes of 296th Meeting of Registration Board

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Minutes of 296th Meeting of Registration Board

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MINUTES OF 296th MEETING OF REGISTRATION BOARD

HELD ON 8th, 9th & 10th SEPTEMBER 2020.

Item Detail of Item Pages

 Import & Vet-I……………………………………….. 2492

 Import & Vet-II............. ................. ............ .............. .. 2512

 Post Registration-I ............... .................. ................ .... 2539

Drug Regulatory Authority of Pakistan

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The meeting was attended by the following:-

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Decision: Registration Board confirmed the minutes of 295th meeting.

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Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

2. Mr. Ammar Ashraf Awan Evaluator PEC-II

3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III

4. Mst.Farzana Raja Evaluator PEC-IV

5. Mst. Iqra Aftab Evaluator PEC-V

6. Mr. Muhammad Umar Latif Evaluator PEC-VI

7. Mst. Sidra Khalid Evaluator PEC-VII

8. Mst. Haleema Sharif Evaluator PEC-VIII

9. Mst. Saima Hussain Evaluator PEC-X

10. Mr. Haneef Ullah Evaluator PEC-IX

11. Mr. Farhadullah Evaluator PEC-XI

12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

13. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

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COMPARISON OF WHO & ICH:

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2.3.S.4.2 Analytical Procedures

2.3.S.4.5 Justification of Specification

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2.3.P.3.5 Process Validation and/or Evaluation

PRACTICES OF VARIOUS REFERENCE REGULATORY AUTHORITIES

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4. Therapeutic Goods Administration (TGA):

6. Pharmaceuticals and Medical Devices Agency (PMDA):

Decision: Keeping in view regulatory practices adopted by various reference regulatory

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II. Applications of local manufacturing by way of contract manufacture:

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Remarks of the Evaluator.

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GMP status New License ( DML # 000906 Dated 28-06-2019)

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a. Deferred cases of New/Additional section(s)

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