Minutes of 323 Meeting of Registration Board Held On 6 To8 December, 2022

MINUTES OF 323rd MEETING OF REGISTRATION BOARD
HELD ON 6th to 8th December, 2022
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Item No. Detail of Item Pages

I. Division of Pharmaceutical Evaluation & Registration ----
Pharmaceutical Evaluation Cell (PEC) ----------------------- 03-2238
Registration-I Section ------------------------------------------- 2239-2261
Registration-II Section ------------------------------------------ 2361-2397
Post Registration-I Section ------------------------------------- 2398-2404
Post Registration-II Section ------------------------------------ 2405-2406
Export Facilitation Desk ---------------------------------------- 2407-2423
Import & Vet-I Section ------------------------------------------ 2424-2445
Import & Vet-II Section ----------------------------------------- 2445-2462
RRR Section ------------------------------------------------------- 2463-2473
II. Division of Biological Evaluation & Research -------------- 2474-2638
III. Division of Quality Assurance & Laboratory Testing ------- 2639-2643
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G-9/4
Islamabad
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Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 1

323rd meeting of Registration Board was held on 6th to 8th December, 2022 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad.
The meeting was chaired by Dr. Obaidullah, Chairman Registration Board DRAP. The
meeting started with recitation of the Holy Verses.
Following members attended the meeting:
1. Ch. Zeeshan Nazir Bajar, Additional Director (PE&R), DRAP. Member/ Secretary
2. Lt. Gen.(R) Prof. Dr. Karamat A. Karamat (HI-M.SI-M), Former Member

Surgeon General Pakistan.
3. Dr. Noor us Saba, Director, Biological Evaluation & Research Division, Member
DRAP
4. Mr. Iftikhar A. Chaudhary, Hospital Pharmacist, Lahore Member
5. Mr. Hafeez ur Rehman, DTL, Rawalpindi Member
6. Dr. Imranullah Khan, Director, DTL, Peshawar Member
7. Mr. Muhammad Aslam, Deputy Draftsman-I, Ministry of law & Justice, Member
Islamabad.
8. Mr. Ajmal Sohail Asif, Director, Division of QA&LT Member
9. Mrs. Muneeza Khan, Representative of Division of MD&MC Member
10. Mr. Ghulam Mujtaba, Deputy Director, Representative of IPO Member
11. Maj. Gen. (R) Dr. Tahir Mukhtar Sayed, Inspector General (Hospitals), Co-opted Member
Fauji Foundation, Rawalpindi (Online)
12. Dr. Qurban Ali, Ex-Director General, National Veterinary Laboratories, Co-opted Member
Islamabad
13. Dr. Muhammad Akram, Animal Husbandry Commissioner, M/o Co-opted Member
NFS&R
Mr. Nadeem Alamgir (Pharma Bureau), Mr. Khalid Munir, Mr. Hamid Raza & Mr. Jalal-
ud-Din (PPMA) and Mr. Ziaulhaq (PCDA) attended the meeting as observers.
Deputy Director (PEC) was assisted by respective Assistant Directors for presentation of the
agenda. Director, BE&R was assisted by respective Additional Director and Assistant Directors for
presentation of the agenda.

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

1. Mr. Farooq Aslam Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst. Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Ishtiaq Shafique Evaluator PEC-VI
7. Mr. Muhammad Usman Evaluator PEC-VIII
8. Mr. Adil Saeed Evaluator PEC-IX
9. Mst. Najia Saleem Evaluator PEC-X
10. Dr. Farhadullah Evaluator PEC-XI
11. Mr. Shahid Nawaz Evaluator PEC-XIII
12. Mst. Saima Hussain Evaluator PEC-XV
13. Mr. Akbar Ali Evaluator PEC-XVI
14. Mr. Zia Ullah Evaluator PEC-XVII
15. Mr. Muneeb Ahmed Evaluator PEC-XVIII
16. Mst. Sana Kanwal Evaluator PEC-XX
17. Mr. Ahsan Hafiz Assistant Director

Item No. I: Division of Pharmaceutical Evaluation & Registration
Item No. XIII: Agenda of Evaluator-X
1. Name and address of manufacturer / M/s Biogen Pharma, 8-Km Chakbeli Road, Rawat,
Applicant Rawalpindi
Brand Name +Dosage Form + Doxycol Oral Powder 20%/500 MIU
Strength
Composition Each Kg Contains:
Doxycycline Hyclate…20% w/w
Colistin Sulphate…500MIU
Diary No. Date of R& I & fee Dy.No 13760 dated 07-03-2019 Rs.20,000/- dated 07-03-
2019
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specification Manufacturer’s specifications
100gm, 250gm, 500gm, 1Kg, 5Kg, 25Kg: As
Pack size & Demanded Price recommended by the PRC/ (M/o NHS, R&C)/ Federal
Govt.
Me-too status Could not be verified in the applied strength
GMP status cGMP certificate dated 30-07-2020 based on inspection
conducted on 12-12-2019.
Remarks of the Evaluator X  The firm has provided conversion of Colistin Sulphate
MIU to mg.
1mg Colistin Sulphate contains 20000 IU
Shortcomings:
 Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) along with
registration number, brand name and name of firm.
 Provide evidence of pharmacopoeial reference of
finished product specification. In case, the product is
non pharmacopoeial, submit
 Fee Rs. 7500/- for revision of finished product
specifications.
Decision: Deferred for following:
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
along with registration number, brand name and name of firm
 Finished product specifications in the light of decision taken in 267th meeting of
Registration Board along with fee Rs.7500/- for revision of finished product specifications
as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Biofon Oral Powder 980mg/gm
Strength
Composition Each Gram Contains:
Trichlorfon…980mg
2019
Pharmacological Group Antiparasitic
Type of Form Form 5
100gm, 250gm, 500gm, 1Kg, 5Kg, 25Kg: As
Govt.
Trifon Powder of M/s S.J. & G. Fazul Ellahie
Me-too status
(PVT) LTD., Karachi. (Reg. No. 049662)
Remarks of the Evaluator X
Decision: Approved with innovator’s specifications upto pack size of 1Kg. The firm shall
submit fee of Rs. 7500/- for pre-approval change in product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Amantagen 10 water soluble powder
Strength
Amantadine HCl…10% w/w
2019
Pharmacological Group Antiviral
Type of Form Form 5
Finished product Specification As per Innovator specifications
100gm, 250gm, 500gm, 1000gm, 5Kg: As
Govt.
Antamits Water Soluble Powder of M/s Wimits
Me-too status
Pharmaceuticals, Lahore (Reg. No. 078316)
Remarks of the Evaluator X Amantadine containing formulation for veterinary use
could not be confirmed in any RRA.
Decision: Referred to Expert working Group to review therapeutic requirement keeping in
view safety, efficacy and quality parameters.
Brand Name +Dosage Form + Oxycain Injection 200mg/20mg
Strength
Composition Each ml Contains:
Oxytetracycline dihydrate…200mg
Lidocaine HCl………………20mg
2019
Type of Form Form 5
Finished product Specification Not mentioned
20ml, 50ml, 100ml: As recommended by the PRC/
Pack size & Demanded Price
(M/o NHS, R&C)/ Federal Govt.
Could not be confirmed in the applied strength and salt
Me-too status
form
Remarks of the Evaluator X  Initially, multiple pack sizes (20ml, 50ml, and 100ml)
of injectable dosage form were demanded in a single
application. Now, the firm has demanded 50ml pack
size.
 Upon clarification regarding proposed brand name
that “Oxylag” has been mentioned on covering letter
and “Oxycain” has been mentioned on both fee
challan and Form-5, the firm has submitted proposed
brand name “Oxycain”
Shortcomings:
 Evidence of applied formulation/drug already
approved by DRAP (generic / me-too status) along

with registration number, brand name and name of
firm.
non pharmacopoeial, submit product specification in
the light of decision taken in 267th meeting of
Registration Board.
 Fee Rs. 7,500/- for revision of finished product
specifications.
Brand Name +Dosage Form + BG Vit Injection 100,000IU/40,000IU/40mg
Strength
Vitamin A…100,000IU
Vitamin D3…40,000IU
Vitamin E…40mg
2019
Pharmacological Group Growth promoter
Type of Form Form 5
20ml, 50ml, 100ml: As recommended by the PRC/
Vital forte injection (100ml) of M/s Selmore.(Reg. No.
Me-too status
095649)
 Initially, multiple pack sizes (20ml, 50ml, and 100ml)
of injectable dosage form were demanded in a single
application. Now, the firm has demanded 100ml pack
size.
 Upon clarification regarding proposed brand name
since “BG VET Injection ” is mentioned on covering
letter and Form-5 while “BG VIT Injection ” is
mentioned on fee challan and Vital Forte injection is
mentioned on master formula. The firm has submitted
proposed brand name BG Vit injection
Decision: Approved with innovator’s specifications with 100ml pack size. The firm shall submit
fee of Rs. 7500/- for pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Neodexa Injection 50mg/100,000 IU/50mg/0.5mg
Strength
Kanamycin Sulphate…50mg
Colistin Sulphate…100,000 IU
Neomycin Sulphate…50mg
Dexamethasone…0.5mg
Diary No. Date of R& I & fee Dy.No 13753 dated 07-03-2019 Rs.20,000 dated 07-03-
2019 (Fee challan is missing)
Pharmacological Group Antibacterial/ Steroid
Type of Form Form 5
10ml, 30ml, 50ml, 100ml: As recommended by the PRC/
KONO DEX Injection of M/s Alina Combine
Me-too status
Pharmaceutical (Pvt) Ltd. Karachi (Reg. No. 052347)
Remarks of the Evaluator X  Original Fee challan is missing, provide original
yellow copy for fee verification as per procedure
adopted by the Registration Board in its 285th
meeting.
Registration Board.
 Provide conversion of Colistin Sulphate IU to mg.
 Fee Rs.7,500/- for revision of finished product
specifications.
 Initially, multiple pack sizes (10ml, 30ml, 50ml,
100ml) of injectable dosage form were demanded in
a single application. Now, the firm has demanded
50ml pack size.
Shortcoming:
Evidence of approval of Liquid injection (Steroid)
Section

Brand Name +Dosage Form + Bromogen Super Oral Solution 4% w/w
Strength
Bromhexine HCl…4% w/w
2019
Pharmacological Group Mucolytic
Type of Form Form 5
100ml, 250ml, 500ml, 1000ml: As recommended by the
PRC/(M/o NHS, R&C)/ Federal Govt.
Me-too status Could not be confirmed in the applied strength
Remarks of the Evaluator X  Provide evidence of pharmacopoeial reference of
Registration Board.
specifications.
firm.
 Correction in label claim is required since Each ml
Contains: Bromhexine HCl…4% w/w is mentioned
instead of w/v
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm
Registration Board.
 Fee Rs.30,000/- for revision /pre-approval correction of label claim as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Bromogen 2% Solution
Strength
Bromhexine Hcl…2% w/v
2019
Type of Form Form 5
Me-too status Could not be confirmed in the applied strength
Registration Board.
specifications.
firm.
status) along with registration number, brand name and name of firm
Registration Board.
 Fee Rs.30,000/- for revision /pre-approval correction of label claim as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Enroflox Oral Liquid 10gm/50MIU
Strength
Composition Each 100ml Contains:
Enrofloxacin…10Gm
2019
Type of Form Form 5
Finished product Specification Not provided
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml: As recommended by the
Coliflox Solution of M/s Selmore Pharmaceutical (Pvt)
Me-too status
Ltd., Lahore. (Reg. No. 071082)
Remarks of the Evaluator X  The firm has provided conversion of Colistin Sulphate
MIU to mg.
1mg Colistin Sulphate contains 20000 IU
 Upon clarification regarding applied strength of
Enrofloxacin, since Enrofloxacin…10Gm/100ml is
mentioned in label claim on Form-5 while in master
formula Enrofloxacin…100mg/100ml is mentioned; the
firm has clarified that Enrofloxacin…10Gm/ 100ml is
required.
Decision: Approved with innovator’s specifications. Registration letter shall be issued upon
submission of fee of Rs.30,000/- for revision /pre-approval correction of label claim as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Flor Plus Solution 25% w/v
Strength
Florfenicol…25% w/v
2019
Type of Form Form 5
Finished product Specification As per Innovator specifications
Florfenicol Oral Liquid of M/s ATTABAK
Me-too status
Pharmaceuticals, Islamabad. (Reg. No. 075707)
Decision: Approved
Brand Name +Dosage Form + Enromizin Oral Liquid
Strength
Enrofloxacin…75mg
Sulphamethoxypyridazin…75mg
Sulphamethazin…50mg
Trimethoprim…25mg
2019
Type of Form Form 5
Finished product Specification Not provided
Sinaset Oral Liquid of M/s Decent Pharma, Islamabad.
Me-too status
(Reg. No. 095624)

Registration Board.
specifications.
submission of fee of Rs.7500/- for revision/pre-approval correction of finished product
specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Vita CE Oral Liquid
Strength
Composition Each Litre Contains:
Vitamin E Acetate…200000mg
Vitamic C Ascorbic Acid…2000mg
Sodium Selenite…2200mg
Zinc As Sulphate…10000mg
2019
Pharmacological Group Nutritional supplement
Type of Form Form 5
50ml, 100ml, 250ml, 500ml, 1000ml: As recommended by
the PRC/(M/o NHS, R&C)/ Federal Govt.
Me-too status Could not be confirmed.
Registration Board.
 Fee Rs. 7,500/- for inclusion of finished product
specifications.
firm.
 Undertaking as per 251st meeting of Registration
Board has not been signed by Production manager and
Quality Control manager.
13. Name and address of manufacturer / M/s Amarant Pharmaceuticals Pvt Ltd.
Applicant 158-D, Tore, Gadap Road, Super Highway, Karachi
Brand Name +Dosage Form + Respolex Oral Powder

Strength
Tylosin Tartrate…200mg
Doxycycline HCl…400mg

2019
Type of Form Form 5
Finished product Specification Inhouse specifications
Pack size & Demanded Price As per SRO/As per SRO
ETER-DOX WATER SOLUBLE POWDER Reg. No. 109
Me-too status
863
GMP status Panel inspection report dated 15-02-2021 for renewal of
DML.
Remarks of the Evaluator X  Approval of Powder Section Veterinary confirmed
vide letter No. F. 2-4/99-Lic (Vol-II) dated 15-06-
2021.
 Tylosin Tartrate…200mg/gm and Doxycycline
HCl…400mg/gm is mentioned throughout the dossier
while Tylosin Tartrate…250mg/gm and Doxycycline
HCl…200mg/gm is mentioned on cover letter;
clarification is required for which strength you want
to apply this dossier.
 Full fee of registration for revision of quantities of
APIs and inclusion of finished product
specifications.
firm.
 Master formulation describing quantities of actives
and inactives alongwith their justification/role of
ingredients.
 Initially firm has applied for formulation containing
Doxycycline HCl and now revised formulation in line
with reference product as mentioned below:
Each 100Gram Contains:
Tylosin tartrate …………20gm
Doxycycline hyclate …...40gm
Decision: Approved with following label claim and with Innovator’s Specifications:
Each 100gm contains:
Tylosin tartrate …………20gm
Doxycycline hyclate …...40gm
Registration letter shall be issued after submission of fee of Rs.30,000/- for revision /pre-
approval correction in formulation as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
Brand Name +Dosage Form + Micotil Oral Liquid 250mg/ml

Strength
Tilmicosin As Phosphate…250mg
2019
Type of Form Form 5
Micosil Oral Liquid of M/s Fizi Pharmaceuticals and
Me-too status
Chemical Laboratories, Lahore.(Reg. No. 103830)

DML.
Remarks of the Evaluator X  Approval of Liquid Section Veterinary confirmed
panel inspection report dated 15-02-2021 for renewal
of DML.
Registration Board.
 Full fee of registration for revision of master formula
in terms of equivalency and adjustment of weight as
per salt factor and inclusion of finished product
specifications.
Decision: Approved with following label claim and with innovator’s specifications.
Each ml Contains:
Tilmicosin Phosphate…250mg
05-2021.
Brand Name +Dosage Form + Broncolex Oral Liquid 50mg/ml

Strength
Bromhexine (as HCl)…50mg
2019
Type of Form Form 5
Me-too status BIOHEXIN 5% SOLUTION Reg. No. 103973.
DML.
of DML.
Registration Board.
specifications.
Decision: Approved with following label claim and with innovator’s specifications.
Each ml Contains:
Bromhexine HCl…50mg
05-2021.
Brand Name +Dosage Form + Enrocon Oral Liquid 20gm/4gm
Strength

Enrofloxacin…20Gm
Colistin Sulphate…4Gm
2019
Type of Form Form 5
Me-too status Not provided
DML.
of DML.
Registration Board.
specifications.
firm.
Brand Name +Dosage Form + Virakil Oral Powder 10gm
Strength
Composition Each 100Gm Contains:
Amantadine HCl…10Gm
2019
Type of Form Form 5
Amandin Water Soluble Powder of M/s FIZI
Me-too status Pharmaceuticals and Chemical Laboratories, Lahore.(Reg.
No. 103819)
DML.
 Approval of Powder Section Veterinary confirmed
2021.
Registration Board.

specifications.
Brand Name +Dosage Form + Neolex-P Oral Powder 72gm

Strength
Composition Each 100gm Contains:
Neomycin Sulphate…72gm
2019
Type of Form Form 5
Me-too status NEOSEL-72 ORAL POWDER Reg. No. 088098
DML.
2021.
Registration Board.
specifications.
Decision: Approved with innovator’s specifications. Registration letter shall be issued after
submission of fee of Rs.30,000/- for revision /pre-approval correction in formulation as per
Brand Name +Dosage Form + Tybrox Oral Liquid

Strength
Doxycycline Hyclate…200mg
Colistin Sulphate…0.5 MIU
Bromhexine…5mg
2019
Pharmacological Group Antibiotic/Mucolytic
Type of Form Form 5
Me-too status RESPIDOX-T ORAL LIQUID Reg. No. 079120
DML.
2021.

Registration Board.
specifications.
 Master formulation describing quantities of actives
and inactives alongwith their justification/role of
ingredients.
 Provide conversion of Colistin Sulphate MIU to mg.
 Firm has revised formulation as under:
Each ml Contains:
Bromhexine………5mg
Decision: Approved with Innovator’s Specification and with following label claim:
“Each ml Contains:
Bromhexine………5mg”
05-2021.
Brand Name +Dosage Form + Fenlex Oral Liquid 23gm
Strength
Florfenicol…23gm
2019
Type of Form Form 5
Me-too status BAFLOR-23 ORAL SOLUTION. Reg. No. 071096
DML.
 Approval of Powder Section Veterinary confirmed
2021.
specifications.
Brand Name +Dosage Form + Lexi-Dox Oral Powder 500mg

Strength
Composition Each gram Contains:
2019

Type of Form Form 5
Me-too status SELDOX POWDER Reg. No. 058717
DML.
Remarks of the Evaluator X Approval of Powder Section Veterinary confirmed vide
letter No. F. 2-4/99-Lic (Vol-II) dated 15-06-2021.
22. Name and address of manufacturer / M/s Farm Aid Group, Plot # 3/2, Phase I & II, Hattar
Applicant Industrial Estate, Haripur
Brand Name +Dosage Form + Aro Mox Powder 200mg/10,00,000IU

Strength
Composition Each gm Contains:
Amoxicillin…200mg
Colistin Sulphate…10,00,000IU
2019
Pharmacological Group Broad spectrum beta-lactam-polypeptide Antibiotic
Type of Form Form 5
10gm, 20gm, 30gm,50gm, 100gm, 250gm, 500gm, 1kg,
5kg, 10kg, 15kg, 20kg, 25kg: Decontrolled
Colistin-Mox 200/1 Water Soluble Powder of M/s. Eterna
Me-too status
Pharma (Pvt) Ltd., Mirpur, AJK. (Reg. No. 113578)
Remarks of the Evaluator X  Approval of Dry Penicillin Powder Section
Veterinary confirmed vide letter No. F. 3-9/91-Lic
(Vol-I) dated 21-06-2017.
finished product specification. In case, the product
is non pharmacopoeial, submit product
specification in the light of decision taken in 267th
meeting of Registration Board.
 Revise the master formula and/or label claim as per
reference product for equivalency and adjustment of
weight as per salt factor.
 Full fee of Registration for revision of master
formula and/or label claim as per reference product
specifications.
Decision: Approved with following label claim and with innovator’s specifications upto pack
size 1Kg:
Each gm Contains:
Amoxicillin as trihydrate…200mg
Colistin Sulphate…10,00,000IU
05-2021.
Brand Name +Dosage Form + Gumbo Care Powder
Strength
Potassium Citrate…18gm
Sodium Citrate…12gm
Vitamin B1…0.03gm
Vitamin B2…0.015gm
Nicotinamide…0.32gm
Menadione Bisulfite…0.115gm
Vitamin C…1.10gm
2019
Pharmacological Group Vitamin preparation
Type of Form Form 5
Finished product Specification As per innovator’s specifications
Anti Gumbo Powder of M/s Leads Pharma (Pvt) Ltd.,
Me-too status
Islamabad (Reg. No. 046581)
 Approval of Dry Penicillin Powder Section
(Vol-I) dated 21-06-2017.
Decision: Approved upto pack size of 1Kg.
Brand Name +Dosage Form + D-20 Powder

Strength
Composition Each 100gm powder contains:
Doxycycline HCl…20gm
2019
Pharmacological Group Antibacterial
Type of Form Form 5
Me-too status NEODOX-20 POWDER Reg. No. 111427
Remarks of the Evaluator X  Oral Powder General Veterinary section
confirmed from cGMP certificate dated 14-10-2022
based on inspection conducted on 15-04-2022.
for equivalency and adjustment of weight as per salt
factor.
Decision: Approved upto pack size of 1Kg.


Brand Name +Dosage Form + E-Line Liquid 10gm/4gm/10gm
Strength
Enrofloxacin…10gm
Aminophylline…4gm
Guaifenesin…10gm
2019
Pharmacological Group Tetracycline antibiotic, bronchodilator, expectorant
Type of Form Form 5
50ml, 100ml, 200ml, 250ml, 500ml, 1Liter, 2.5Liter,
5Liter, 10Liter, 15Liter, 20Liter, 25Liter,: Decontrolled
EG Enro Plus Liquid of M/S Elegance Pharmaceutical,
Me-too status
Chak Belli, Rawalpindi (Reg. No. 074099)
Remarks of the Evaluator X Oral Liquid General Veterinary section confirmed from
cGMP certificate dated 14-10-2022 based on inspection
Decision: Approved upto pack size of 1Litre.
Brand Name +Dosage Form + Fendox Liquid 20gm/10gm/8gm/20gm

Strength
Tylosin Tartrate…10gm
Aminophylline…8gm
Guaifenesin…20gm
2019
Pharmacological Group Tetracycline antibiotic, bronchodilator, expectorant
Type of Form Form 5
50ml, 100ml, 200ml, 250ml, 500ml, 1Liter, 2.5Liter,
5Liter, 10Liter, 15Liter, 20Liter, 25Liter,: Decontrolled
TYCO-G ORAL LIQUID of M/s ATTABAK
Me-too status
X
Remarks of the Evaluator Oral Liquid General Veterinary section confirmed from
cGMP certificate dated 14-10-2022 based on inspection
Decision: Approved upto pack size of 1Litre.
27. Name and address of manufacturer / M/s Nawan Laboratories (Pvt) Ltd.
Applicant 136 sector 15 Korangi Industrial Area Karachi.
Brand Name +Dosage Form + Napravin IMM Injector 3gm
Strength
Composition Each 3Gm Syringe Contains:
Cefalonium As Dihydrate……250mg
2019
Pharmacological Group Antibacterial for intramammary use, cephalosporin
Type of Form Form 5

Finished product Specification BP specifications
Pack size & Demanded Price 3gm/injector tube; Decontrolled
Cepravin TM Dry Cow Intra Mammary of M/S ICI
Me-too status
Pakistan Ltd Karachi (Reg. No. 020133) (as SYRINGE)
GMP status Last GMP inspection is conducted on 25-01-2022 and the
report concludes that firm was considered to be operating
at good level of overall GMP compliance
Remarks of the Evaluator X Approval of Liquid injection section (veterinary)
(Cephalosporin) confirmed vide letter No.F. 2-10/93-Lic
(Vol-I) dated 10-03-2022
Decision: Approved
28. Name and address of manufacturer / M/s Nawan Laboratories (Pvt) Ltd.
Applicant 136 sector 15 Korangi Industrial Area Karachi.
Brand Name +Dosage Form + Nefa-Mac IMM Injector 10ml
Strength
Composition Each 10ml Syringe Contains:
Cephalexin Monohydrate…200mg
Cloxacillin Benzathine…500mg
Vitamin A…10,000 IU
2019
Pharmacological Group Antibiotic infusion for dry cows
Type of Form Form 5
Pack size & Demanded Price 10ml; Decontrolled
Me-too status Cefa sec of M/s Mustafa brothers. Reg No. 053956
at good level of overall GMP compliance
Remarks of the Evaluator X  Approval of Liquid injection section (veterinary)
(Cephalosporin) confirmed vide letter No.F. 2-10/93-
Lic (Vol-I) dated 10-03-2022.
 Provided following conversion of vitamin A from IU to
mg
Potency of Vitamin A Palmitate per syringe = 6.25mg
non pharmacopoeial, submit product specification in the
light of decision taken in 267th meeting of Registration
Board.
Decision: Approved with innovator’s Specifications and with following label claim:
“Each 10ml Syringe Contains:
Cephalexin as Monohydrate…200mg
Neomycin as Sulphate…340mg
Cloxacillin Benzathine…500mg
Vitamin A…10,000 IU”
 Registration letter shall be issued after submission of fee of Rs.30,000/- for revision /pre-
approval correction in formulation as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
Brand Name +Dosage Form + M-10 Powder

Strength
Amoxicillin Base…100mg

2019
Pharmacological Group Broad spectrum beta-lactam-polypeptide Antibiotic
Type of Form Form 5
Me-too status Could not be confirmed
Remarks of the Evaluator X  Approval of Dry Penicillin Powder Section
(Vol-I) dated 21-06-2017.
specifications.
firm.
Board has not been provided on company’s
letterhead.
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.
30. Name and address of manufacturer / M/s Inshal Pharmaceutical Industries, Plot No. 2, Street SS
Applicant 2, National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Peractin-T Injection 20mg/ml
Strength
Ivermectin…20mg
2019
Pharmacological Group Anthelmentic
Type of Form Form-5
Finished product Specification BP Vet specifications
FLORAMEC Injection of M/s D-MAARSON
Me-too status
PHARMACEUTICALS, ISLAMABAD (Reg. No. 078343)
Remarks of the Evaluator X  Liquid Injection Section (Veterinary) confirmed
from Inspection report dated 11-05-2018 for renewal
of DML

New suggested name: Ivoshell 20mg injection

Firm has revised finished product specification from
in-house to “BP Vet specifications” along with the fee
of Rs. 7,500/- via deposit slip no 4580995498.
Decision: Approved with BP (Vet) specifications.
31. Name and address of manufacturer / M/s Inshal Pharmaceutical Industries.
Applicant Plot No. 2, Street SS 2, National Industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Ivoshell 10mg Injection
Strength
Ivermectin…10mg
2019
Type of Form Form-5
IVOBAK Injection of M/s Attabak Pharmaceuticals,
Me-too status
of DML
 Firm has revised finished product specification from
in-house to “BP Vet specifications” along with the fee
Decision: Approved with BP (Vet) specifications.
Islamabad
Brand Name +Dosage Form + Ivoshell super Injection 10/100mg
Strength
Ivermectin…10mg
Clorsulon…100mg
2019
Type of Form Form-5
100ml; Decontrolled
Ivobak-C Injection of M/s Attabak Pharmaceuticals,
Me-too status
of DML
in-house to “as per innovator’s specifications” along
with the fee of Rs. 7,500/- via deposit slip no
08194455.
Decision: Approved with innovator’s specifications.

Islamabad
Brand Name +Dosage Form + Dyrox N Powder
Strength
Streptomycin Sulphate…400mg
Sulfaguanidine…4gm
Kaolin…4gm
Pectin…400mg
Bismuth Subnitrate…2gm
Vitamin A Acetate…80,000IU
2019
Pharmacological Group Anti-bacterial, anti-diarrhoeal, Anti-infective
Type of Form Form-5
12gm, 60gm,100gm, 150gm, 250gm, 500gm, 1000gm,
2.5Kg; Decontrolled
Diarrobak Water Soluble Powder of M/s Attabak
Me-too status
Pharmaceuticals Islamabad. (Reg. No.063835)
Remarks of the Evaluator X  Oral powder Section (Veterinary) confirmed from
Inspection report dated 11-05-2018 for renewal of
DML.
inhouse to “as per innovator’s specifications” along
8636532536.
 Moreover, the firm has provided following conversion
of vitamin A acetate from IU to mcg.
1 IU= 0.3mcg of Vitamin A acetate.

34. Name and address of manufacturer / M/s Grand Pharma, Plot No. 5-A, St. No N-5, National
Applicant Industrial Zone, RCCI Estate, Rawat, Islamabad
Brand Name +Dosage Form + Bromofloxin Oral Liquid

Strength
Enrofloxacin…20gm
Bromhexine HCl…5gm
2019
Pharmacological Group Antibiotic/ anti-bacterial
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, 5Liter; Decontrolled
Rofl Liquid of M/s Inshal Pharmaceutical Industries,
Me-too status
Islamabad. (Reg. no. 101976)
at good level of GMP compliance.
Remarks of the Evaluator X  Approval of Oral Liquid Section (General)
(veterinary) confirmed vide letter No.F. 1-36/2006-Lic
(Vol-III) dated 29-09-2021.

Firm has revised finished product specification from
645001089019.
Brand Name +Dosage Form + Tilmobiotic Oral Solution
Strength
Tilmicosin As Tilmicosin Phosphate…250mg
2019
Pharmacological Group Anti-bacterial
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml; Decontrolled
TIL MICO STER 25% Oral Liquid of M/s Aamster
Me-too status
Laboratories, Islamabad.(Reg. No. 101427)
(veterinary) confirmed vide letter No.F. 1-36/2006-Lic
(Vol-III) dated 29-09-2021.
26322561.
Brand Name +Dosage Form + Floristin Oral Solution
Strength
Florfenicol…………23gm
Colistin Sulphate…..50MIU
2019
Pharmacological Group Antibiotic/ Antibacterial
Type of Form Form 5
Noaflotin Oral Solution of M/s. Noa Hemis
Me-too status
Pharmaceuticals, Karachi. (Reg. No. 106679)
(veterinary) confirmed vide letter No.F. 1-36/2006-
Lic (Vol-III) dated 29-09-2021.
54711720218.
 Florfenicol…23gm/100ml was mentioned in label
claim on Form-5 while Florfenicol…23mg/100ml was

mentioned in master formula; upon clarification the
firm has submitted revised master formula as per
reference product.
 Moreover, the firm has provided following conversion
of Colistin Sulphate.
1mg of Colistin Sulphate = 19000 IU .
Decision: Approved with following label claim:
“Each 100ml Contains:
Florfenicol ………… 23gm
Colistin Sulphate …... 50MIU”
Registration letter shall be issued after submission of differential fee of Rs.22500/- for
revision of formulation as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
37. Name and address of manufacturer / M/s Delux Chemical Industries.
Applicant L-T 26, A/1, Landhi Industrial Area, Karachi
Brand Name +Dosage Form + Reotilcon Solution 250mg/ml
Strength
Tilmicosin…250mg
2019
Type of Form Form 5
Finished product Specification Not claimed
Tilcosin-25 Oral Solution of M/s Nawan Lab Karachi
Me-too status
(Reg. No. 058986)
GMP status Firm submitted DML renewal inspection report dated 09-
06-2022.
(veterinary) is confirmed from DML renewal
inspection.
Registration Board.
 Firm has submitted fee of Rs. 7,500/- for correction
in specifications via deposit slip no 13235420.
Decision: Approved with Innovator’s Specifications.
38. Name and address of manufacturer / M/s Delux Chemical Industries, L-T 26, A/1, Landhi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Reoflor C Solution
Strength
Florfenicol…230gm
Colistin Sulphate…50 MIU
2019
Type of Form Form 5
C-Flor Oral Liquid of M/s Nawan Lab Karachi (Reg. No.
Me-too status
074782)
06-2022.

inspection.
Registration Board.
 Provided conversion of Colistin sulphate from MIU
to gm i.e. 1mg = 19000IU.
Brand Name +Dosage Form + Derox 24% Liquid
Strength
Enrofloxacin…10gm
Aminophylline…4gm
Guaifenesin…10gm
2019
Pharmacological Group Antibiotic/ Expectorant
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml; Decontrolled
ANROX PLUS-10% ORAL LIQUID of M/s BIO-Labs
Me-too status
(Pvt) Ltd., Islamabad (Reg. No. 033240)
06-2022.
inspection.
Registration Board.
Brand Name +Dosage Form + Deox-L Suspension
Strength
Oxyclozanide…150mg
Levamisole as HCl…75mg
2019
Pharmacological Group Anthelmintic
Type of Form Form 5
Pack size & Demanded Price 50ml, 100ml, 150ml, 500ml, 1Liter; Decontrolled
SPECTRUM DRENCH of M/s Fizi Pharmaceuticals and
Me-too status
Chemical Laboratories, Lahore. (Reg. No. 081331)

06-2022.
inspection.
Registration Board.
Decision: Approved with Innovator’s Specifications with following label claim:
Oxyclozanide…150mg
Levamisole HCl…75mg”
Firm shall submit differential fee of Rs.22500/- for correction in formulation , as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021, before issuance of registration
letter.
Brand Name +Dosage Form + Reoquintel Suspension
Strength
Triclabendazole…12% w/v
Levamisole…7.5% w/v
2019
Type of Form Form 5
Prequintel Suspension of M/s Noble Pharma, Mirpur Azad
Me-too status
Kashmir. (Reg. No. 063637)
06-2022.
inspection.
Registration Board.
 Levamisole…7.5% w/v is mentioned in label claim
on Form-5 while Levamisole HCl…7.5gm/100ml is
mentioned in master formula; revise label claim
and/or master formula as per reference product
accordingly.
 Full fee of registration for revision of master formula
and/or label claim in terms of equivalency and
adjustment of weight as per salt factor and inclusion
of finished product specifications.
Triclabendazole……12% w/v
Levamisole HCl……7.5% w/v”
Firm shall submit fee of Rs.30000/- for correction in formulation , as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021, before issuance of registration letter.
Brand Name +Dosage Form + Reotrime Oral suspension
Strength
Sulphadiazine…80gm
Trimethoprim…16gm
2019
Type of Form Form 5
Me-too status NOBI-TRIME SUSPENSION Reg. No. 058736
06-2022.
 Approval of Oral Liquid Section (General)
inspection.
Registration Board.
specifications.
 Firm has revised formulation as under:
Each 200ml Contains:
Trimethoprim…16gm
Trimethoprim…16gm
Tylosin Tartrate…2gm”
Brand Name +Dosage Form + Reodox-C Powder
Strength
Tylosin Tartarte…10%
Doxycycline Hyclate…20%
2019
Type of Form Form 5
Pack size & Demanded Price 100gm, 200gm, 500gm, 1Kg, 2.5Kg; Decontrolled

CT-DOX WATER SOLUBLE POWDER Reg. No.
Me-too status
048172
06-2022.
Remarks of the Evaluator X  Approval of Oral Powder Section (General)
inspection.
Registration Board.
to gm i.e. 1mg= 19000IU
Brand Name +Dosage Form + Reo DTCB Powder
Strength
Bromhexine…10gm
2019
Type of Form Form 5
50gm, 100gm, 200gm, 500gm, 1Kg, 2.5Kg, 5Kg;
Decontrolled
MONODOXWATER SOLUBLE POWDER Reg. No.
Me-too status
087142
06-2022.
inspection.
Registration Board.
 Full fee of Registration for revision of label claim
and master formula and inclusion of finished product
specifications.
to gm i.e. 1mg = 19000IU
 Revise label claim and master formula in terms of salt
form of Bromhexine, in line with reference product
and adjust its weight as per salt factor accordingly.
Each 1000gm Contains:
 Firm shall submit fee of Rs.30000/- for correction in formulation , as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021, before issuance of registration letter.
Brand Name +Dosage Form + Delxin-TD Powder
Strength
Bromhexine…5gm
2019
Type of Form Form 5
MAXDOXWATER SOLUBLE POWDER Reg. No.
Me-too status
087144
06-2022.
inspection.
Registration Board.
 Bromhexine…5gm/1000gm is mentioned in label
claim on Form-5 while Bromhexine…0.5gm/1000gm
is mentioned in master formula; revise label claim
and/or master formula as per reference product
accordingly.
 Full fee of Registration for revision of label claim
and master formula and inclusion of finished product
specifications.
to gm i.e 1mg = 19000IU
“Each 1000gm Contains:
Bromhexine HCl…5gm”
Brand Name +Dosage Form + Reo TDC 680 Powder
Strength
Tyloson Tartarte…200gm
Colistin Sulphate…60gm
Bromhexine…20gm

2019
Type of Form Form 5
Pack size & Demanded Price 100gm, 200gm, 500gm, 1Kg, 2.5Kg,5Kg; Decontrolled
Nobi TDC 680 Powder of M/s Noble Pharma, Mirpur
Me-too status
Azad Kashmir. (Reg. No. 062127)
06-2022.
inspection.
Registration Board.
Tyloson Tartarte…200gm
Firm shall submit differential fee of Rs.22500/- for correction in formulation , as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021, before issuance of registration
letter.
Brand Name +Dosage Form + Reoneo 72% Powder
Strength
2019
Type of Form Form 5
NOBINEO oral Powder of M/s Noble Pharma, Mirpur
Me-too status
Azad Kashmir. (Reg. No. 058726)
06-2022.
inspection.
Registration Board.
Decision: Approved with Innovator’s Specifications

Brand Name +Dosage Form + Reo Asper C Powder
Strength
Acetylsalicyclic Acid…6.70gm
Vitamin C…20gm
2019
Pharmacological Group Antistress in action
Type of Form Form 5
Pack size & Demanded Price 100gm, 200gm, 500gm, 1Kg, 2.5Kg, 5Kg; Decontrolled
Gesix-C Water Soluble Powder of M/s PRIX
Me-too status
Pharmaceutica (Pvt) Ltd., Lahore. (Reg. No. 043286)
06-2022.
inspection.
Registration Board.
specifications.
Board has not been provided.
Shortcomings:
Justification/ clarification regarding compatibility of
Acetylsalicyclic Acid with Vitamin C
Brand Name +Dosage Form + Reolincol Powder
Strength
Lincomycin Sulphate…100mg
2019
Type of Form Form 5
Pack size & Demanded Price 100gm, 200gm, 500gm, 1Kg, 2.5Kg, 5Kg; Decontrolled
Me-too status NOBI-LINCOL POWDER Reg. No. 079116
06-2022.
 Approval of Oral Powder Section (General)
inspection.
Registration Board.
specifications.
Decision: Approved with Innovator’s Specifications
Brand Name +Dosage Form + Reoamant 10% Powder
Strength
Amantadine HCl…10gm
2019
Pharmacological Group Anti-viral
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm; Decontrolled
Amandin Water Soluble Powder of M/s FIZI
Me-too status Pharmaceuticals and Chemical Laboratories, Lahore.(Reg.
No. 103819)
06-2022.
Remarks of the Evaluator X  Latest cGMP inspection report (conducted within the
period of last three years) is 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.
Registration Board.
Brand Name +Dosage Form + Reo CCNS Powder
Strength
Chlortetracycline HCl…200mg
Colistin Sulphate…10mg
2019
Type of Form Form 5
Pack size & Demanded Price 100gm, 500gm, 1000gm; Decontrolled
Chlorocept Water Soluble Powder of M/s PRIX
Me-too status
Pharmaceutica (Pvt) Ltd., Lahore. (Reg. No. 073996)
06-2022.

inspection.
Registration Board.
52. Name and address of manufacturer / M/s Noble Pharma, Plot No. B-1 Old Industrial Area,
Applicant Mirpur, Azad Kashmir
Brand Name +Dosage Form + Nobidox C Powder
Strength
Tylosin Tartarte…10%
Doxycycline Hyclate…20%
2019
Type of Form Form 5
Pack size & Demanded Price 100gm,500gm, 1Kg and 5Kg jars; Decontrolled
CT-DOX Water Soluble Powder of M/s Attabak
Me-too status
GMP status Panel inspection of M/s Noble Pharma, Azad Kashmir has
been carried out on 09-02-2022. It was observed to do a lot
of improvements in HVAC, Pharmaceutical Quality
systems including documentation and other quality
related areas. The firm submitted improvements in these
areas. A detailed report would be submitted later on after
verification of same through onsite inspection.
 Approval of Veterinary Oral Powder (General)
section confirmed vide letter No.F. 5-2/2007-Lic
dated 08-07-2015
 Firm has claimed inhouse specifications along with
the fee of Rs. 7,500/- via deposit slip no 2011480749
for inclusion of finished product specification.
 Moreover, the firm has submitted conversion of
Colistin MIU to mg:
1mg=19000IU
Now calculate it for 1000gm (1Kg)
1mg 19000IU
X 500MIU (1M IU= 100000IU)
X= 500,00000IU x 1mg/ 19000IU
X=2631.57mg
X=2.631gm
Decision: Approved with innovator’s specifications. Registration letter will be issued after
satisfactory GMP compliance report by QA&LT Division.
Brand Name +Dosage Form + Nobioxfen T Suspension
Strength

Oxfendazole…22.65gm
Triclabendazole…85gm
2019
Pharmacological Group Anthelmintic/ De wormer
Type of Form Form 5
Finished product Specification In-house specifications
Triloxal Oral Suspension of M/s D-HAANS
Me-too status
Pharmaceuticals, Azad Kashmir. (Reg. No. 102249)
systems including documentation and other quality related
areas. The firm submitted improvements in these areas. A
detailed report would be submitted later on after verification
of same through onsite inspection.
Remarks of the Evaluator X  Approval of Veterinary Oral Liquid (General)
section confirmed vide letter No.F. 5-2/2007-Lic dated
08-07-2015
 Initially Oxfendazole…22.65 and
Triclabendazole…85gm /1000ml was mentioned in
label claim on Form-5 while Albendazole…10gm,
Ivermectin 0.2gm and Triclabendazole…12gm/ 100ml
was mentioned in master formula; upon clarification the
firm has submitted the correct composition as
mentioned below:
 Firm has claimed inhouse specifications along with the
fee of Rs. 30,000/- via deposit slip no 56115640 for
correction of formulation in label claim/ master
formula.
Decision: Approved with innovator’s specifications with following label claim:
 Registration letter will be issued after satisfactory GMP compliance report by QA&LT
Division.
Brand Name +Dosage Form + Flukacure Suspension
Strength
Fenbendazole…50mg
Rafoxanide…50mg
2019
Pharmacological Group Anthelmintic/ De wormer
Type of Form Form 5
FEN FOXAMIDE LIQUID of M/s Leads Pharma Pvt.
Me-too status
Ltd., Islamabad. (Reg. No.058837)

Remarks of the Evaluator X  Approval of Veterinary Oral Liquid (General)
section confirmed vide letter No.F. 5-2/2007-Lic
dated 08-07-2015
the fee of Rs. 7,500/- via deposit slip no 34095710 for
inclusion of finished product specification.
satisfactory GMP compliance report by QA&LT Division.
Brand Name +Dosage Form + Nobispiracin Injection
Strength
Composition Each ml contains:
Spiramycin Adipate…125mg
Lincomycin HCl…75mg
2019
Type of Form Form 5
Pack size & Demanded Price 50ml,100ml; Decontrolled
I-Spiralink Injection of M/s International Pharma Labs,
Me-too status
Lahore. (Reg. No. 062074)
Remarks of the Evaluator X  Approval of Veterinary Liquid Vial Injection
(General) section confirmed vide letter No.F. 5-
2/2007-Lic dated 08-07-2015
the fee of Rs. 7,500/- via deposit slip no 218112547
for inclusion of finished product specification.
 Separate registration is granted to separate pack
size/fill volume of injectable dosage form. However,
multiple pack sizes of injectable dosage form are
demanded in a single application. So clarification is
required for which pack size/ fill volume you want to
apply this dossier.
satisfactory GMP compliance report by QA&LT Division and selection of one fill volume.
Brand Name +Dosage Form + Nobiket Injection
Strength
Ketoprofen…100mg

2019
Pharmacological Group Analgesic
Type of Form Form 5
Finished product Specification BP Vet Specifications
Dinalgen Injection of M/s Mylab (Pvt) Ltd. Bahawalpur.
Me-too status
(Reg. No. 074012)
Remarks of the Evaluator X  Approval of Veterinary Liquid Vial Injection
(General) section confirmed vide letter No.F. 5-
2/2007-Lic dated 08-07-2015
 Firm has claimed BP Vet specifications without
submitting fee for inclusion of finished product
specifications.
57. Name and address of manufacturer / M/s Star Laboratories Pvt Ltd., 23-km, Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Maxin Plus Injection
Strength
Oxytetracycline (as dihydrate) …300mg
Flunixin (as Maglumine)…20mg
2019
Pharmacological Group Antibacterial/Anti-inflammatory
Type of Form Form 5
Pack size & Demanded Price 50ml; As per SRO
Flunox Injection 300mg/ 20mg of M/s S.J & G Fazul
Me-too status
Ellahie (Pvt.) Ltd, Karachi. (Reg. No. 093828)
Remarks of the Evaluator X  Approval of Liquid injectable (veterinary) section
confirmed vide panel inspection dated 14-12-2015
report for renewal of DML.
 Firm has claimed manufacturer’s specifications
and the applied product is non-pharmacopoeial.
 Lignocain HCl is included in list of ingredients
mentioned in master formula while the same has not
been reflected in label claim and outline of method
of manufacture; upon clarification the firm has
submitted that “Lignocain HCL included in master
formulation as excipient and its role is local
anesthetic to avoid the injection pain”.
 However, Hexasol LA Solution for Injection
(HPRA approved) does not contain Lignocain
HCl.
Decision: Approved with innovator’s specifications. Firm shall submit correct master
formulation excluding Lignocaine HCl in line with reference product before issuance of

registration letter with submission of Rs.30000/- fee as per notification No.F.7-11/2012-
B&A/DRAP dated 07-05-2021.
58. Name and address of manufacturer / M/s Ras Pharmaceuticals Pvt Ltd.,25-km, Lahore Road,
Applicant Multan
Brand Name +Dosage Form + Bromoras M Oral Liquid
Strength
Menthol…………..40mg
2019
Pharmacological Group Mucolytic/Expectorant
Type of Form Form 5
Pack size & Demanded Price 50ml, 100ml, 250ml, 500ml, 1Liter, 5Liter, 25Liter; N/A
Bromo-Plus Liquid of M/s Elegance Pharmaceutical,
Me-too status
Rawalpindi. (Reg. No.073917)
at fair level of GMP compliance.
 Oral Liquid (Antibiotic) Vet section confirmed vide
panel inspection report based on inspection dated 10-
03-2021 for renewal of DML
76654590792.
Decision: Approved with innovator’s specification upto pack size of 1Litre.Registration letter
will be issued after satisfactory GMP report by QA&LT Division within 3 years.
59. Name and address of manufacturer / M/s Ras Pharmaceuticals Pvt Ltd.,25-km, Lahore Road,
Applicant Multan
Brand Name +Dosage Form + Methenasol-C Oral Powder
Strength
Methenamine …90gm
Vitamin B1……700mg
Vitamin C……..100mg
Sorbitol……..…5gm
2019
Pharmacological Group Anti-infective Vitamins
Type of Form Form 5
10gm, 15gm, 25gm, 50gm, 100gm, 250gm, 500gm,1Kg,
2.5Kg, 5Kg, 10Kg, 25Kg; N/A
A-Flush Water Soluble Powder of M/s Attabak
Me-too status
Remarks of the Evaluator X  Oral Powder (General) Vet section confirmed vide
inhouse to “as per innovator’s specifications”
along with the fee of Rs. 7,500/- via deposit slip no
7506281702.

Decision: Approved with innovator’s specifications upto pack size of 1Kg. Registration letter
60. Name and address of manufacturer / M/s ICI Pakistan Limited Life Sciences, 45-KM, off
Applicant Multan Road, Lahore
Brand Name +Dosage Form + Promectin Alpha Injection 10ml
Strength
Ivermectin…10mg
Clorsulon…100mg
2019
Pharmacological Group Endectocide, anthelmintic Flukicide
Type of Form Form 5
Finished product Specification USP specifications
Pack size & Demanded Price 10ml vial; Decontrolled
Ivorok-Plus Injection of M/s Manhattan Pharma Karachi
Me-too status
(Reg. No. 052368)
Remarks of the Evaluator X  Liquid Injectable (SVP) Vet section granted vide letter
No. F.1-41/2007-Lic-(Vol-I) dated 10-07-2017.
 Firm has revised finished product specification to “USP
specifications” along with the fee of Rs. 7,500/- via
deposit slip no 8344981661.
Decision: Approved with USP specifications.
Strength
Ivermectin…10mg
Clorsulon…100mg
2019
Type of Form Form 5
JFMEC-Super Injection of M/s Jfrin Pharmaceuticals, Hub
Me-too status
Industrial Estate Balochistan. (Reg. No. 041211) .
No. F.1-41/2007-Lic-(Vol-I) dated 10-07-2017
 Firm has revised finished product specification to
“USP specifications” along with the fee of Rs. 7,500/-
via deposit slip no 65612724.
Strength
Ivermectin…10mg
Clorsulon…100mg
2019
Type of Form Form 5
JFMEC-Super Injection of M/s Jfrin Pharmaceuticals, Hub
Me-too status
Industrial Estate Balochistan. (Reg. No. 041211) .
 Liquid Injectable (SVP) Vet section granted vide letter
No. F.1-41/2007-Lic-(Vol-I) dated 10-07-2017.
 Firm has revised finished product specification to “USP
specifications” along with the fee of Rs. 7,500/- via
Brand Name +Dosage Form + Promectin Injection 10ml
Strength
Ivermectin…10mg
2019
Type of Form Form 5
Pandex 1% Injectable Solution of M/s Khyber Poultry
Me-too status
Faisalabad. (Reg. No. 018859)
 Firm has revised finished product specification to “BP
Vet specifications” along with the fee of Rs. 7,500/- via
Decision: Approved with BP Vet specifications.
Strength
Ivermectin…10mg
2019
Type of Form Form 5
Pandex 1% Injectable Solution of M/s Khyber Poultry
Me-too status
 Liquid Injectable (SVP) Vet section granted vide letter
Remarks of the Evaluator X The firm has withdrawn application vide their letter No.
nil dated 11-10-2022
Decision: Registration Board acceded to the firm’s request and declared the application
as disposed of/rejected.
Strength
Ivermectin…10mg
2019
Type of Form Form 5
Avimec Injection of M/s U.M. Enterprises Karachi. (Reg.
Me-too status
No. 019031)
Liquid Injectable (SVP) Vet section granted vide letter No.
F.1-41/2007-Lic-(Vol-I) dated 10-07-2017
Remarks of the Evaluator X The firm has withdrawn application vide their letter No.
nil dated 11-10-2022
Decision: Registration Board acceded to the firm’s request and declared the application
as disposed of/rejected.
Brand Name +Dosage Form + Multimix Injection 50ml
Strength
Vitamin A (palmitate)…15,000IU
Vitamin D3……………1,000IU
Vitamin E (acetate) ...…20mg
Vitamin B1 (HCl) ….…10mg
Vitamin B2 (Riboflavin 5-Phosphate Sodium) …5mg
Vitamin B6…3mg
Nicotinamide…35mg
D-Pantothenol…25mg
Vitamin B12…5mcg
2019
Pharmacological Group Multivitamins
Type of Form Form 5
Multina injection of M/s Nawan laboratories. (Reg. No.
Me-too status
049512)
 Firm has revised finished product specification to “as
per innovator’s specifications” along with the fee of
Rs. 7,500/- via deposit slip no 1711081231
 Provided conversion of Vitamin A and Vitamin D3
from IU to mg.
VITAMIN A (Palmitate) BP .. 15,000 IU (8.82mg)
(Vitamin A is equivalent to 1700IU/mg)
VITAMIN D3 BP….. 1,000 IU (25mcg)

(Vitamin D is equivalent to 40,000 IU/mg)
Decision: Deferred for clarification regarding inclusion of both oil and water soluble vitamins
in same formulation of injection dosage form.
Brand Name +Dosage Form + Multimix Injection 100ml
Strength
Vitamin A (palmitate)…15,000IU
Vitamin D3……………1,000IU
Vitamin E (acetate) ...…20mg
Vitamin B1 (HCl) ….…10mg
Vitamin B2 (Riboflavin 5-Phosphate Sodium) …5mg
Vitamin B6…3mg
Nicotinamide…35mg
D-Pantothenol…25mg
Vitamin B12…5mcg
2019
Type of Form Form 5
Multina injection of M/s Nawan laboratories. (Reg. No.
Me-too status
049512)
 Firm has revised finished product specification to “As
Rs. 7,500/- via deposit slip no 94836692974.
 Provided conversion of Vitamin A and Vitamin D3
from IU to mg.
VITAMIN A (Palmitate) BP .. 15,000 IU (8.82mg)
(Vitamin A is equivalent to 1700IU/mg)
VITAMIN D3 BP….. 1,000 IU (25mcg)

(Vitamin D is equivalent to 40,000 IU/mg)
Decision: Deferred for clarification regarding inclusion of both oil and water soluble vitamins
in same formulation of injection dosage form.
Brand Name +Dosage Form + Triclev Plus Drench 120mg/75mg
Strength
Triclabendazole…120mg
Levamisole HCl…75mg
2019
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml and 1000ml; Decontrolled
Endo Shell Liquid of M/S. Inshal Pharmaceutical Industries,
Me-too status
Islamabad. (Reg. No.103929)
Remarks of the Evaluator X  Veterinary Oral Liquid (General) section granted vide
letter No. F.1-41/2007-Lic dated 06-04-2015
Decision: Approved with innovator’s specification.
Brand Name +Dosage Form + Zolectin Drench
Strength
Composition Each 100ml contains:
Ivermectin……….0.2gm
Albendazole……...10gm
2019
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml and 1000ml; Decontrolled
Thunder Drench of M/s Star Laboratories (Pvt) Ltd, Lahore
Me-too status
(Reg. No. 058941)
Remarks of the Evaluator X  Veterinary Oral Liquid (General) section granted
vide letter No. F.1-41/2007-Lic dated 06-04-2015
Decision: Approved with innovator’s specification.
70. Name and address of manufacturer / M/s Leads Pharma Pvt Ltd. 81-A, Street # 6, I-10/3,
Applicant Islamabad.
Brand Name +Dosage Form + Elyso WS Powder
Strength
Composition Each gram contains:
Lysozyme…22%
Vitamin E 50…0.5%
2019
Pharmacological Group Nutritional supplement
Type of Form Form 5
100gm, 250gm, 500gm, 1Kg, 2.5Kg, 5Kg and 25Kg;
Decontrolled
LISO 10 Powder of M/s Mallard Pharmaceutical (Pvt) Ltd.,
Me-too status
Multan (Reg. No. 049566)
GMP status Panel unanimously recommends the grant of additional
sections based on inspection dated 17-02-2022.
Remarks of the Evaluator X  Approval of Powder Section (General) confirmed
vide letter No.F. 1-26/93-Lic (Vol-I) (M-205) dated
30-04-2007.
49400153.

Decision: Deferred for following clarification:
 Rationale of Lysozyme and vitamin E formulation.
 Evidence of approval status of applied formulation as drug product in reference
regulatory authorities/agencies which were adopted by the Registration Board in its
275th meeting.
Brand Name +Dosage Form + Mentholy Liquid
Strength
Composition Each Litre Contains:
Peppermint…40gm
Eucalyptus Oil…50gm
Menthol…50gm
Vitamin A…30,000,000IU
2019
Pharmacological Group Decongestant
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1Liter, and 5Liter; Decontrolled
Fenetime Oral Solution of M/S Biogen Pharma, Rawat.
Me-too status
(Reg. No. 063815)
 Approval of Liquid Section confirmed vide letter
No.F. 1-26/93-Lic (Vol-I) (M-205) dated 30-04-
2007.
9549820869.
 Firm has submitted following conversion of Vitamin
A from IU to Kg
30,000,000 IU= 17.64gm
1700000 IU per gram
Decision: Referred to committee for review of formulation in grey area as product contains
ingredients regulated as H&OTC product.
Brand Name +Dosage Form + Lincopharm 11 premix
Strength
Lincomycin as HCl…1.1%
2019
Type of Form Form-5
Pack size & Demanded Price 500gm, 1Kg, 2.5Kg, 5Kg and 10Kg; Decontrolled
Bio-Mycin 11% Premix Powder of M/s Bio-Labs (Pvt) Ltd,

Me-too status
Islamabad. (Reg. No. 103971)
Remarks of the Evaluator X  Approval of Powder Section (Antibiotic) confirmed
30-04-2007.
inhouse to “BP Vet specifications”
 The firm has submitted fee of Rs. 30,000/- via deposit
slip no 379582668 for revision of label claim/master
formula in terms of salt form, and finished product
specifications.
Decision: Approved with BP Vet Specifications. Firm shall submit GMP inspection report
conducted within last three years before issuance of registration letter.
Brand Name +Dosage Form + Paraflor Liquid 250gm/200gm
Strength
Florfenicol…250gm
Paracetamol…200gm
2019
Pharmacological Group Antibacterial, antipyretic
Type of Form Form-5
Me-too status Could not be confirmed from the available database
Remarks of the Evaluator X  Approval of Liquid Section confirmed vide letter
No. F. 1-26/93-Lic (Vol-I) (M-205) dated 30-04-
2007.
in-house to “as per innovator’s specifications”
 Initially Paracetamol…200mg/Liter is mentioned in
label claim on Form-5 while Paracetamol…
........40Kg/200Liter is mentioned in master formula;
upon clarification the firm has submitted the correct
formulation as below:
Each 1000ml contains:
Florfenicol…250gm
Paracetamol…200gm
 The firm has provided fee of Rs. 30,000/- via deposit
slip no 436683344 for revision of finished product
specification and correction of strength of API in label
claim/ master formula.
Shortcomings:
firm could not be verified.
 Eevidence of applied formulation/drug already approved by DRAP (generic / me-too
status) along with registration number, brand name and name of firm.
 Review of applied formulation by Expert Working Group
Brand Name +Dosage Form + Tilmisol Liquid
Strength
Tilmicosin as phosphate…250mg

Diary No. Date of R& I & fee Dy. No 2500 dated 03-04-2019 Rs.20,000/- dated 02-04-
2019
Type of Form Form-5
Til Mico Ster 25% Oral Liquid of M/s Aamster
Me-too status
Laboratories, Islamabad. (Reg. No. 101427)
2007.
USP to “as per innovator’s specifications”
specification and revision of label claim in terms of
salt form in line with reference product.
Decision: Approved with innovator’s specifications. Firm shall submit GMP inspection report
Brand Name +Dosage Form + Spectin Powder
Strength
Lincomycin as HCl…33.3%
Spectinomycin Sulphate…66.7%
2019
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, and 1000gm; Decontrolled
Lincotin Powder of M/s Selmore Pharmaceuticals (Pvt)
Me-too status
Remarks of the Evaluator X  Approval of Powder Section (Antibiotic) confirmed
30-04-2007.
inhouse to “as per innovator’s specifications”.
specification and revision of label claim in terms of salt
form in line with reference product.
 The firm has applied for Lincomycin as HCl…33.3%
and Spectinomycin Sulphate…66.7%/gram, while
the referred generic product contains Lincomycin as
HCl…33.3% and Spectinomycin as
Sulphate…66.7%/gram. Submit evidence of applied
formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand
name and name of firm; or revise formulation in line
with reference product.
Decision: Approved with innovator’s specifications and with following label claim:

Each gram contains:
Lincomycin as HCl………….33.3%
Spectinomycin as Sulphate…66.7%
Firm shall submit GMP inspection report conducted within last three years before issuance of
registration letter.
Brand Name +Dosage Form + Se Amoxylin 80% Powder
Strength
Amoxicillin as trihydrate…80gm
2019
Type of Form Form-5
Dokamox 80% Water Soluble Powder of M/S. Orient
Me-too status Animal Health (Pvt.) Limited,
Karachi. (Reg. No. 082505)
 Approval of Penicillin Dry Powder Section
(Veterinary) confirmed vide letter No.F. 1-34/2013-
Lic dated 11-04-2017.
inhouse to “BP Vet specifications”.
Decision: Approved with BP (Vet) specifications. Firm shall submit GMP inspection report
Brand Name +Dosage Form + Liver Up Liquid
Strength
L Carnitine…5%
Magnesium Sulphate…1%
Sorbitol…20%
Choline Chloride…10%
Betain…2%
Inositol…0.7%
2019
Pharmacological Group Liver supplement
Type of Form Form-5
100ml, 150ml, 250ml, 500ml, 1Liter, and 5Liter;
Decontrolled
Le Vox Liquid of M/s Inshal Pharmaceutical Industries,
Me-too status
2007.
30326971.
Decision: Approved with innovator’s specifications and change of brand name. Firm shall
submit GMP inspection report conducted within last three years before issuance of registration
letter.
Brand Name +Dosage Form + Fancy Flor Liquid 20gm
Strength
Florfenicol…20gm
2019
Type of Form Form 5
Pack size & Demanded Price 500ml, 1Liter, and 5Liter; Decontrolled
Florfen-20% Oral Liquid of M/s Nawal Pharmaceuticals,
Me-too status
Rawalpindi. (Reg. No. 074091)
2007.
1181343038.
Brand Name +Dosage Form + LE-Bro Liquid 20mg/40mg
Strength
Menthol…40mg
2019
Type of Form Form 5
Menbro (Vet) Liquid of M/s Biorific Pharma, Islamabad.
Me-too status
(Reg. No. 083827)
2007.
28217337092.

Brand Name +Dosage Form + Cylic Vit Powder
Strength
Acetyl Salicylic Acid…67gm
Vitamin C…200gm
2019
Pharmacological Group Restorative
Type of Form Form-5
Pack size & Demanded Price 500gm, and 1Kg, 2.5Kg and 5Kg; Decontrolled
Sali-C Powder of M/s Selmore Pharmaceuticals (Pvt) Ltd.,
Me-too status
30-04-2007.
088127575.
Shortcomings:
 Justification/ clarification regarding
compatibility of Acetylsalicyclic Acid with
Vitamin C is required.
Brand Name +Dosage Form + Digesta Powder
Strength
Propionic Acid Calcium...250gm
Propionic Acid Sodium…400gm
Acetanilide…150gm
Magnesium Oxide…125gm
Iron II Sulphate…400mg
Zinc Sulphate…100mg
Magnesium Sulphate…200mg
Copper Sulphate…450mg
Cobalt Sulphate…400mg
Sodium Molybdate…100mg
Sodium Chloride…20gm
Diary No. Date of R& I & fee Form-5 Dy.No 4869 dated 30-04-2019 Rs.20,000/- dated
30-04-2019
Pharmacological Group Appetizing and digestive tonic
Type of Form Form-5
100gm, 250gm, 500gm, 1Kg, 2.5Kg, 5Kg and 25Kg;
Decontrolled
Me-too status Could not be verified
30-04-2007.
3291337165.
firm is required.
(generic / me-too status) along with registration number, brand name and name of firm is
required.
Brand Name +Dosage Form + Lincopharm 15% powder
Strength
Lincomycin as HCl…15%
2019
Type of Form Form-5
Pack size & Demanded Price 500gm, 1Kg, 2.5Kg, and 5Kg; Decontrolled
Lincomicina 150 Ganadexil Oral Powder of M/s Forward
Me-too status
Solutions, Lahore. (Reg. No. 078290)
 Approval of Powder Section (Antibiotic) confirmed
30-04-2007.
inhouse to “USP specifications”.
Decision: Approved with USP specifications. Firm shall submit GMP inspection report
Brand Name +Dosage Form + Trepcin Powder
Strength
Amoxicillin as Trihydrate…100gm
2019
Type of Form Form-5
Pack size & Demanded Price 500gm, 1Kg, 2.5Kg, and 5Kg; Decontrolled
Neo AC Water Soluble Powder of M/s Decent Pharma,
Me-too status
Rawat, Islamabad. (Reg. No. 079844)

Remarks of the Evaluator X  Approval of Penicillin Dry Powder Section
Lic dated 11-04-2017.
59440054000.
Brand Name +Dosage Form + Ampileads Injection 200mg/ml
Strength
Composition Each ml suspension contains:
Ampicillin trihydrate…200mg
2019
Type of Form Form-5
Ampicillin 20% Injection of M/s Nawan Trading Corp.
Me-too status
Remarks of the Evaluator X  Approval of Penicillin Liquid Injection Section
Lic dated 11-04-2017.
95932742.
Brand Name +Dosage Form + Lemoxil 15% Injection
Strength
Amoxicillin Trihydrate eq to Amoxicillin Base…150mg
2019
Type of Form Form-5
Almox 15% LA of M/s Star Labs Lahore. (Reg. No.
Me-too status
020842)
Lic dated 11-04-2017.

inhouse to “BP Vet specifications” along with the fee
Decision: Approved with BP (Vet) specifications. Firm shall submit GMP inspection report
Brand Name +Dosage Form + Ledomentan Injection 140mg/35mg
Strength
Amoxicillin Trihydrate…140mg
Clavulanic Acid as Potassium Clavulanate…35mg
2019
Type of Form Form-5
Nugmentan Injection of M/s Nawan Laboratories (Pvt) Ltd.,
Me-too status
Lic dated 11-04-2017.
inhouse to “As per innovator’s specifications” along
8424591224.
Brand Name +Dosage Form + Combipen Injection
Strength
Benzathine Penicillin G…100,000IU
Procain Penicillin…150,000IU
Dihydrostreptomycin Sulphate…200mg
2019
Type of Form Form-5
Lic dated 11-04-2017.
89895916.
 Provided conversion of Benzathine Penicillin G and
Procain Penicillin from IU to kg as mentioned below:
Benzathine Penicillin G 100,00 IU= 81mg
Procain Penicillin 150,000 IU= 150mg
approved by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm is
required.
required.
Brand Name +Dosage Form + Amcocin Injection
Strength
Colistin Sulphate…250,000IU
2019
Type of Form Form-5
Lic dated 11-04-2017.
6269502340.
 Provided conversion of Colistin sulphate from IU to kg
as mentioned below:
Colistin Sulphate 250,000 IU = 13.15mg
Shortcomings:
 Evidence of applied formulation/drug already approved
by DRAP (generic / me-too status) alongwith
registration number, brand name and name of firm is
required.
required.
Brand Name +Dosage Form + Marboxin 100 injection
Strength
Marbofloxacin…100mg
2019
Type of Form Form-5
Marcin Injection (50ml) of M/s Mylab (Pvt) Ltd, Khankah
Me-too status
Sharif, Bahawalpur. (Reg. No. 088117)

Remarks of the Evaluator X  Approval of Liquid Injection Section (General-
Veterinary) confirmed vide panel inspection report
dated 29-11-18 and 01-01-2019, for issuance of gmp
certificate.
inhouse to “as per innovator’s specifications”.
 The firm has provided fee of Rs. 30,000/- via deposit slip
no 362121782530 for revision of finished product
specification and revision of master formula without
overage.
90. Name and address of manufacturer / M/s Selmore Pharmaceuticals Pvt Ltd., 36-Km, Multan
Applicant Road Lahore.
Brand Name +Dosage Form + Seldox Fort Powder
Strength
Doxycycline Hyclate eq to Doxycycline…800mg
2019
Pharmacological Group Antiprotozoal
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, and 1Kg; Decontrolled
Doxyral 80% Water Soluble Powder of M/s Orient Animal
Me-too status
Health (Pvt.) Limited, Karachi. (Reg. No. 082504)
GMP status Panel inspection dated 14-03-2022 for grant of additional
Sections recommends grant of following additional sections
Liquid injectable Cephalosporin (Vet)
Dry Powder Injectable Cephalosporin (Vet)
Liquid injectable Vial-I General (Vet)
Liquid injectable vial-II General (Vet)
External Liquid Preparation (Vet)
External Powder Preparation (Vet)
Remarks of the Evaluator X  Oral powder (Veterinary) section confirmed vide letter
No.F.1-13/2000-Lic (Vol-II) dated 23-01-2019
3833468637.
91. Name and address of manufacturer / M/s Evergreen Pharmaceuticals, 69-70/B, Main Glaxo
Applicant Town, Industrial Area, 20th km Ferozepur Road, Lahore.
Brand Name +Dosage Form + Ever Gold Powder
Strength
Composition Each 1000 gm contains:
Vitamin A...0.8gm
Vitamin D3...0.16gm
Vitamin E...0.38gm
Vitamin B1...1 gm
Vitamin B2...1.25 gm
Copper Sulphate...0.25 gm
Magnesium Sulphate...25 gm
Calcium Chloride...0.023 gm
Zinc Sulphate...2.17 gm
Manganese Sulphate...10 gm
Potassium Iodide...0.5 gm
Sodium Selenite...0.01 gm
Dicalcium Phospate...150 gm
Sodium Chloride...120 gm
Vitamin B6...4 gm
2019
Pharmacological Group Vitamins with minerals
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, and 5Kg; Decontrolled
White Gold Powder of M/s Leads Pharma (Pvt) Ltd
Me-too status
Remarks of the Evaluator X  Approval of Dry Powder Suspension (General)
(veterinary) section confirmed vide letter No.F. 1-
31/2010-Lic dated 25-11-2016
0290350843.
Decision: Approved with innovator’s specifications and change of brand name.
92. Name and address of manufacturer / M/s Majestic Pharma, Plot No. 21, Phase No.1-A, M-3
Applicant Industrial City, Siahanwala, Faisalabad
Brand Name +Dosage Form + Maji Enro-C 10 Oral Liquid
Strength
Enrofloxacin…100gm
2019
Type of Form Form-5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1Liter and 5Liters; Decontrolled
Encohil Oral Liquid of M/s. Hilton Pharma (Pvt.) Ltd.,
Me-too status
Karachi. (Reg. No.103943)
GMP status Panel inspection report for grant of DML based on
inspection dated 17-10-2017 recommends the grant of DML
Remarks of the Evaluator X  Oral liquid (General) section confirmed vide letter
No. F.1-10/2015-Lic dated 26-12-2017
3590933586.
 Provided following conversion of Colistin Sulphate
from MIU to gm.
19000 IU =1mg
satisfactory GMP compliance report conducted within last 3 years by QA&LT Division.

Brand Name +Dosage Form + Maji Flor-C Oral Liquid
Strength
Florfenicol…23gm
2019
Type of Form Form-5
Fenicol Liquid of M/s. Univet Pharmaceuticals,
Me-too status
Remarks of the Evaluator X  Oral liquid (General) section confirmed vide letter
No. F.1-10/2015-Lic dated 26-12-2017
20168845.
 Provided following conversion of Colistin Sulphate
from MIU to gm.
19000 IU =1mg
Brand Name +Dosage Form + Maji Flor 25 Oral Liquid
Strength
Florfenicol…250mg
2019
Type of Form Form-5
Lofen Oral Liquid of M/s. Inshal Pharmaceutical Industries,
Me-too status
Remarks of the Evaluator X 
Oral liquid (General) section confirmed vide letter
No. F.1-10/2015-Lic dated 26-12-2017
92634356.
Brand Name +Dosage Form + Maji Tylo-D40 Oral WSP
Strength

2019
Type of Form Form-5
100gm, 250gm, 500gm, 1Kg, 5Kg, 10Kg and 25kg;
Decontrolled
Tb-Dox Powder of M/s. Attabak Pharmaceuticals,
Me-too status
Oral powder (General) section confirmed vide letter
No. F.1-10/2015-Lic dated 26-12-2017
591695159.
Brand Name +Dosage Form + Maji Flox Oral Water Soluble Powder
Strength
Florfenicol…150mg
Oxytetracycline HCl…150mg
2019
Pharmacological Group Antibiotics
Type of Form Form-5
Finished product Specification As Per Innovator’s Specifications
100gm, 250gm, 500gm, 1Kg, 5Kg, 10Kg and 25kg;
Decontrolled
Floxybar 30 Water Soluble Powder of M/s. Baariq
Me-too status
Pharmaceuticals, Lahore. (Reg. No. 072601)
Oral powder (General) section confirmed vide letter
No. F.1-10/2015-Lic dated 26-12-2017
817315860
Applicant Lahore.
Brand Name +Dosage Form + Amolinc Water Soluble Powder
Strength
Composition Each 100gm contains:
Lincomycin…8.8gm
Spectinomycin…8.8gm
Amoxicillin …20gm
2019
Type of Form Form 5
Finished product Specification As per innovator”s specifications
Pack size & Demanded Price 100gm, 500gm, 1Kg; Decontrolled
Amoxpeclin Oral Powder of M/s Selmore. (Reg. No.
Me-too status
102086)
Remarks of the Evaluator X Initially, the firm has applied for
Lincomycin…8.8gm
Spectinomycin…8.8gm
Amoxicillin …20gm per 100gram, Now the firm has
revised formulation as mentioned below:
Lincomycin HCl…8.8gm
Spectinomycin dihydrochloride…8.8gm
Amoxicillin trihydrate …20gm
 Full fee of registration vide slip no. 58064003778 for
revision of label claim/ master formula, and finished
product specifications.
 Approval of “Penicillin Oral powder (veterinary)”
section/manufacturing facility by the Central
Licensing Board. However, you may submit panel
inspection report for renewal of DML verifying the
section/manufacturing facility is required.
Decision: Deferred for evidence of Penicillin Oral powder (veterinary) section.
Applicant Lahore.
Brand Name +Dosage Form + Amantacin Water Soluble Powder
Strength
Enrofloxacin…10gm
Colistin…3.5gm
Amantadine…4gm
2019
Pharmacological Group Antibacterial/anti-viral
Type of Form Form 5
Me-too status Enflox Plus Powder, Reg. No. 052344.
Remarks of the Evaluator X  Firm has submitted approval of Oral Dry Powder
Suspension (veterinary) Section.
 Firm has revised spec to “As per Innovator’s
Specifications”
 Firm has revised formulation as per reference with
submission of full fee vide challan No. 0379985438
as
Enrofloxacin…10gm
Colistin sulphate…3.5gm

Rationale of amantadine with antibiotics formulation
Applicant Lahore.
Brand Name +Dosage Form + Tydox Water Soluble Powder
Strength
Composition Each Kg contains:
Doxycycline Hyclate…210gm
2019
Type of Form Form 5
Me-too status DOXIN W/S POWDER, Reg. No. 017908
 Firm has submitted approval of Oral Dry Powder
Specifications”
submission of fee of rs. 30,000/- vide challan No.
54849919984 as
Each gram contains:
Decision: Approved with innovator’s specifications as per following label claim:

“Each gram contains:
Doxycycline HCl…200mg”
Applicant Lahore.
Brand Name +Dosage Form + Levapoul water Soluble Powder
Strength
Levamisole HCl…15% w/w
2019
Pharmacological Group Anti-parasitic
Type of Form Form 5
Lemisole Powder of M/s Symans Pharmaceuticals, Lahore.
Me-too status
(Reg. No. 013686)
Remarks of the Evaluator X  Approval of Oral powder sachet
(General/Antibiotic) (veterinary) section confirmed
vide panel inspection dated 14-12-2015 report for
renewal of DML.
95642091693.
Applicant Lahore.
Brand Name +Dosage Form + Mandin Water Soluble Powder
Strength
2019
Pharmacological Group Dopaminergic
Type of Form Form 5
Hansredin 98% Powder of M/s D-Haans Pharmaceuticals,
Me-too status Plot No. 9/A, Industrial Estate, Bhimber, Azad Kashmir.
(Reg. No. 102207)
Remarks of the Evaluator X  Approval of Oral powder sachet
(General/Antibiotic) (veterinary) section confirmed
vide panel inspection dated 14-12-2015 report for
renewal of DML.
1992629762.
Applicant Lahore.
Brand Name +Dosage Form + Bronchez Water Soluble Powder
Strength
Composition Each 100gm of Powder Contains:
Doxycycline Hyclate…20gm
2019
Pharmacological Group Antibacterial/ Mucolytic
Type of Form Form 5
Confirm salt form and equivalency factor as per reference
Me-too status product

Remarks of the Evaluator X  Approval of Oral Dry powder/ Sachet
(General/Antibiotic) Veterinary Section confirmed
from panel inspection report for renewal of DML
verifying the section/manufacturing facility.
 Firm has submitted approval of Oral Dry Powder
Specifications”

submission of fee of Rs. 30,000/- vide challan
No.598581354 as
Each Kg Contains:

“Each Kg Contains:
Bromhexine HCl…10gm”
Applicant Lahore.
Brand Name +Dosage Form + Febrol Injection 50ml
Strength
Aceclofenac…25mg
2019
Pharmacological Group NSAID/Antipyretic
Type of Form Form 5
Pack size & Demanded Price 1 x 50ml vial; As per SRO
Vetafenac-Super Injection of M/s S.J. & G. Fazul Ellahie
Me-too status
(Pvt) Limited, Karachi. (Reg. No. 046569)
 Approval of Liquid injectable (veterinary) section
4746891203.
Applicant Lahore.
Brand Name +Dosage Form + Uriflo Water Soluble Powder
Strength
Magnesium Sulphate…35gm
Potassium Chloride…400mg
Furosemide…20gm
Calcium Carbonate…40gm
2019
Pharmacological Group Diuretic with electrolytes
Type of Form Form 5

Neyphralyte Powder of M/s Selmore Pharmaceutical (Pvt)
Me-too status Ltd., Lahore. (Reg. No.071072)

Remarks of the Evaluator X  Oral powder Sachet (General/Antibiotic)
(veterinary) section confirmed by the panel inspection
dated 14-12-2015 report for renewal of DML.
 Initially the firm has applied for Sodium
Chloride…35gm
Furosemide…20gm
Calcium Carbonate…40gm/1000gm, now revised the
formulation in light with reference product as
mentioned below:
Furosemide…20gm
 Full fee of registration for revision of label claim/
master formula, and finished product specifications.
Vide slip no. 266932344829
Decision: Approved with innovator’s specifications and change of brand name and with
following label claim:
Furosemide………….20gm
105. Name and address of manufacturer / M/s Ras Pharmaceutical Pvt Ltd., 25-km, Lahore Road,
Applicant Multan
Brand Name +Dosage Form + Doxytil-BC Oral Liquid
Strength
2019
Type of Form Form 5
Finished product Specification As per Innovator’s specifications
50ml, 100ml, 250ml, 500ml, 1Liter, 5Liter, 10Liter and
25Liter; N/A
Tycodox-Plus Liquid of M/s Attabak Pharmaceutical
Me-too status
Remarks of the Evaluator X  Oral Liquid (Antibiotic) Vet section confirmed vide

 The firm has submitted that 1mg Colistin Sulphate is
not less than 20000 IU.
Decision: Approved upto pack size of 1Litre. Registration letter will be issued after satisfactory
GMP report by QA&LT Division within 3 years.
Applicant Multan
Brand Name +Dosage Form + Sulfaras Oral Liquid
Strength
Enrofloxacin………………..75mg
Sulphamethoxy Pyridazine…75mg
Sulphamethazine……………50mg
Trimethoprim……………….25mg
2019
Type of Form Form 5
50ml, 100ml, 200ml, 250ml, 500ml, 1Liter, 5Liter, 10Liter
and 25Liter; N/A
Enroprim-S Liquid of M/s Elegance Pharmaceuticals,
Me-too status
Rawalpindi. (Reg. No.106675) without Cinoxin
panel inspection report based on inspection dated 10-03-
2021 for renewal of DML
 Upon clarification that Enrofloxacin (cinoxin) was
mentioned throughout the dossier while cinoxin
(ciprofloxacin) is registered brand of M/s Searle IV
Solutions Lahore, the firm has submitted that: “We used
Enrofloxacin as raw material (active) in previous product
which are registered and use for me-too status Cinoxin
(Enrofloxacin) is mentioned. Nowadays, Cinoxin is not
produced while Enrofloxacin is produced and available
in market. Cinoxin is used as raw active material. We
used Enrofloxacin as active material so please consider
as Enrofloxacin ”
Decision: Approved with innovator’s specifications upto pack size of 1Litre.
Applicant Multan
Brand Name +Dosage Form + Albamectin Oral Liquid
Strength
Albendazole…10gm
Triclabendazol…12gm
Ivermectin…0.2gm
2019
Pharmacological Group Dewormer/Anthelmentic

Type of Form Form 5
50ml, 100ml, 200ml, 250ml, 500ml, 1Liter, 5Liter, and
25Liter; N/A
Levamectin Oral Liquid of M/s Elegance Pharmaceuticals,
Me-too status
Decision: Approved with pack size upto 1Litre.
Applicant Multan
Brand Name +Dosage Form + Anthazol CS Suspension
Strength
Oxyclozanide…62.50mg
Oxfendazole…22.65mg
Cobalt Chloride…1.67mg
Sodium Selenite…0.50mg
2019
Pharmacological Group Dewormer/Anthelmentic, Minerals Supplement
Type of Form Form 5
25Liter; N/A
Oxfendaox Plus Oral Drench of M/s Baariq
Me-too status
Pharmaceuticals, Lahore. (Reg. No.075786)
Remarks of the Evaluator X  Oral Liquid (Antibiotic) Vet section confirmed
vide panel inspection report based on inspection
dated 10-03-2021 for renewal of DML
Applicant Multan
Brand Name +Dosage Form + Vermicid Oral Suspension
Strength
Oxfendazole…22.65mg
Cobalt Sulphate…3.82mg
2019
Pharmacological Group Dewormer/Anthelmentic, Minerals Supplement
Type of Form Form 5
25Liter; N/A
Oxfendacon Plus Drench of M/s Vetcon Pharmaceuticals
Me-too status
(Pvt) Ltd, Bhimber, Azad Jamu Kashmir (Reg. No. 57194)
Remarks of the Evaluator X  Oral Liquid (Antibiotic) Vet section confirmed
vide panel inspection report based on inspection
dated 10-03-2021 for renewal of DML
Decision: Approved with pack size upto 1Litre and change of brand name.
Applicant Multan
Brand Name +Dosage Form + Albendaras Oral Liquid
Strength
Albendazole…100mg
2019
Pharmacological Group Dewormer/Anthelmentic
Type of Form Form 5
25Liter; N/A
Albensel-10 Drench of M/s Selmore Pharmaceuticals (Pvt)
Me-too status
X
Remarks of the Evaluator Oral Liquid (Antibiotic) Vet section confirmed vide panel
inspection report based on inspection dated 10-03-2021 for
renewal of DML
111. 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 + El-Trilev-Sc Drench
Strength
Levamisole………75mg
Cobalt Sulphate…0.75mg
2019
Pharmacological Group Antiplatyhenmintics/ Anthelmentic
Type of Form Form 5
Pack size & Demanded Price 100ml, 450ml, and 1000ml; Decontrolled
GMP status Not submitted
Registration Board.
 Revise label claim/master formula in terms of salt
form in line with reference product and adjust its
weight as per salt factor in master formula
accordingly.
approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name
of firm.

 Latest GMP Inspection report conducted within last three years.
Brand Name +Dosage Form + El-Keto Injection 100mg/ml
Strength
Ketoprofen…100mg
2019
Pharmacological Group NSAID, Analgesic, Antipyretic
Type of Form Form 5
Ketoject Injection of M/s Selmore Pharmaceuticals (Pvt)
Me-too status
Registration Board.
specifications.
Brand Name +Dosage Form + Ketoproline Injection
Strength
Oxytetracycline…200mg
Ketoprofen…30mg
2019
Pharmacological Group Antibiotic, Antipyretic
Type of Form Form 5
Registration Board.
accordingly.
of firm.
 Lidocain HCl is included in list of excipients
mentioned in master formula and outline of method
of manufacture while the same has not been reflected
in label claim, clarify.
Brand Name +Dosage Form + El-Trilev Drench
Strength
Levamisole…75mg
2019
Pharmacological Group Antiplatyhenmintics/ Anthelmentic
Type of Form Form 5
Pack size & Demanded Price 100ml, 450ml, and 1000ml; Decontrolled
Me-too status ENDO SHELL LIQUID, Reg. No. 103929
GMP status GMP inspection dated 03-03-2021 grants renewal of DML.
 Firm has Oral Liquid (general)Veterianry section.
Registration Board.
accordingly.
“Each ml Contains:
Levamisole HCl…75mg”
05-2021.
Islamabad
Brand Name +Dosage Form + Tri-Mox LA 15% Injection
Strength
Amoxicillin as Amoxicillin Trihydrate…150mg
2019
Type of Form Form-5
Pack size & Demanded Price 100ml vials; Decontrolled
Almox 15% LA of M/s Star Labs Lahore. (Reg. No.

Me-too status
020842)
of DML.
inhouse to “BP Vet specifications” along with the fee
Decision: Approved
116. Name and address of manufacturer / M/s Inshal Pharmaceutical Industries. Plot No. 2, Street SS
Applicant 2, National Industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Genta Prim Injection
Strength
Gentamycin Sulphate…30mg
Trimethoprim…25mg
Sulfadimidine…125mg
2019
Type of Form Form-5
100ml vials; Decontrolled
Gentabak-Plus Injection of M/s Attabak Pharmaceuticals,
Me-too status
of DML.
797973866.
 Gentamycin Sulphate…30gm/ml is mentioned in
label claim on form-5, while the referred generic
product contains Gentamycin as
Sulphate.....30mg/ml. Submit evidence of applied
formulation/drug already approved by DRAP (generic
/ me-too status) alongwith registration number, brand
name and name of firm; or revise label claim in line
with reference product and submit fee accordingly for
revision of label claim/ master formula.
Each ml contains:
Gentamycin as Sulphate…30mg
Trimethoprim……………25mg
Sulfadimidine……………125mg
Registration letter shall be issued after submission of differential fee of Rs.22500/- for revision
/pre-approval correction in formulation as per notification No.F.7-11/2012-B&A/DRAP dated
07-05-2021.
117. Name and address of manufacturer / M/s Hawk Bio Pharma Pvt Ltd. Plot # 10, Street # s-6,
Applicant National Industrial Estate, RCCI, Rawat, Rawalpindi.
Brand Name +Dosage Form + Hawk Enbro Liquid
Strength
Enrofloxacin…200mg
2019
Pharmacological Group Antibiotic/Mucolytic
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, and 2.5Liter; Decontrolled
Bromoflox Oral Solution of M/S Mylab (Pvt) Ltd.
Me-too status
Khanqah Sharif, Bahawalpur (Reg. No. 073905)
GMP status Last panel inspection was conducted on 19-11-2020 for the
grant of renewal of DML
Remarks of the Evaluator X  Veterinary oral Liquid (antibiotic) and Veterinary oral
Liquid (general) sections confirmed vide letter No. F.
1-31/2011- Lic (M-235) dated 03-07-2013.
 The product is non-pharmacopoeial.
Decision: Approved with Innovator’s Specifications and with pack size upto 1Liter.
Registration letter shall be issued after submission of fee of Rs.7500/- for revision /pre-approval
correction in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
Brand Name +Dosage Form + Quinohawk Liquid
Strength
Enrofloxacin…10gm
Colistin Sulphate…48 M.I.U
2019
Type of Form Form 5
Pack size & Demanded Price 100ml, 500ml, 1000ml, and 2.5Liter; Decontrolled
Poly Quin Liquid of M/s Elegance Pharmaceuticals,
Me-too status

GMP status  Last panel inspection was conducted on 19-11-2020
for the grant of renewal of DML
Remarks of the Evaluator X  Veterinary oral Liquid (antibiotic) and Veterinary oral
Liquid (general) sections confirmed vide letter No. F.
1-31/2011- Lic (M-235) dated 03-07-2013.
 Moreover, the firm has submitted that the theoretical
potency of colistion sulphate is 800µg base
activity/mg.
Decision: Approved with Innovator’s Specifications and with pack size upto 1Liter.
Registration letter shall be issued after submission of fee of Rs.7500/- for revision /pre-
approval correction in product specifications as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
Brand Name +Dosage Form + Tydocol-B Oral Powder
Strength
Bromhexine …1gm
2019
Pharmacological Group Antibiotic/ Mucolytic
Type of Form Form 5
Tylokail Powder of M/s Kailgon Agro Industries (Pvt)
Me-too status
Ltd., Balochistan. (Reg. No. 079140)
GMP status Last panel inspection was conducted on 19-11-2020 for the
grant of renewal of DML
Remarks of the Evaluator X  Veterinary oral Powder (antibiotic) and Veterinary
oral Powder (general) sections confirmed vide letter
No. F. 1-31/2011- Lic (M-235) dated 03-07-2013.
Decision: Approved with Innovator’s Specifications and with pack size upto 1Kg.
dated 07-05-2021.
120. Name and address of manufacturer / M/s Decent Pharma, Plot No. 30, Street SS-3, National
Applicant Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Euromint Liquid
Strength
Vitamin A…30,000,000 IU
Menthol…50gm
Eucalyptus…50gm
Peppermint…40gm
2019
Pharmacological Group Supplement/ counterirratative
Type of Form Form 5
50ml, 100ml, 150ml, 200ml, 450ml, 500ml, 1Liter,
2.5Liter, 5Liter, 10Liter and 20Liter; Decontrolled
Fenetime Oral Solution of M/s Biogen Pharma, Rawat.
Me-too status
(Reg. No. 063815)
conducted on 09-05-2022
Remarks of the Evaluator X  Oral Liquid (General) section confirmed vide
panel inspection dated 10-03-2022, 21-04-2022 and
09-05-2022 report for approval of DML.
 The firm has submitted fee Rs. 7,500/- for revision
of finished product specifications via deposit slip no
041403599512.
 The firm has submitted that Vitamin A Palmitate
1.7MIU/gram
 Initially the firm has applied for formulation
containing Vitamin A ………30,000,000 IU,
Menthol…50gm, Eucalyptus…50gm,
Peppermint…40gm/ml. However, the referred
generic product contains same quantities as applied
per liter. Now the firm has submitted following
revised formulation as per reference product
Each Liter Contains:
Vitamin A…30,000,000 IU
Menthol…50gm
Eucalyptus…50gm
Peppermint…40gm
Shortcomings:
 Balance Fee Rs. 22,500/- for revision of
formulation
Brand Name +Dosage Form + Thiacol 25% Liquid
Strength
Thiamphenicol…250mg
2019
Type of Form Form 5
Thiafen Oral Liquid of M/s. Farm Aid Group, Haripur.
Me-too status
(Reg. No.102204)
81799710.
Decision: Approved with Innovator’s Specifications with pack size upto 1Litre.
Brand Name +Dosage Form + Avimec Oral Liquid
Strength
Ivermectin…10mg

2019
Type of Form Form 5
Ivotek Drench 1% of M/s Star Laboratories (Pvt) Ltd.,
Me-too status
 Oral Liquid (General) section confirmed vide
Brand Name +Dosage Form + Bonaid Minerals Granular Powder
Strength
Calcium…155gm
Phosphorus…135gm
Magnesium…55gm
Sodium…45gm
Iron as Ferrous…1gm
Zinc…..3gm
Manganese…2gm
Copper…0.6gm
Cobalt…0.01gm
Iodine…0.04gm
2019
Pharmacological Group Macro and mineral mixture
Type of Form Form 5
100gm, 200gm, 500gm, 1Kg, 2.5Kg, 5Kg, 10Kg, 20Kg
and 25Kg; Decontrolled
L.S. Minerals Powder of M/s Nawan Labs Karachi (Reg.
Me-too status
No. 021306)
Remarks of the Evaluator X  Oral Powder (General) section confirmed vide
0329580112.
Decision: Deferred for complete salt form, requisite fee and generic status.
Brand Name +Dosage Form + Tilmix Oral Solution
Strength
Tilmicosin…250mg
2019

Type of Form Form 5
Tilcosin solution of M/s Selmore Pharmaceuticals (Pvt)
Me-too status
 The firm has claimed manufacturer’s
specifications and submitted fee Rs. 7,500/- for
revision of finished product specifications via
125. Name and address of manufacturer / M/s Bio Labs Pvt Ltd. Plot # 145, Industrial Triangle,
Applicant Kahuta Road, Islamabad.
Brand Name +Dosage Form + Bio-CT 20% WSP
Strength
Composition Each Gram Powder Contains:
Chlortetracycline HCl…200mg
2019
Pharmacological Group Antibacterial and anti-protozoal
Type of Form Form 5
100gm, 500gm, and 1000gm; As recommended by PRC
(MOH)
Velle CT 20% W.S. Powder of M/s K&K Pharmaceuticals,
Me-too status
dated 03-08-2021
Remarks of the Evaluator X  Approval of Oral Dry powder section
(veterinary) confirmed vide panel inspection report
for inspection dated 08-07-2021, 15-07-2021, 30-
07-2021 and 03-08-2021 for renewal of DML.
Decision: Approved.
Brand Name +Dosage Form + Bio-Amoxi Col WSP
Strength
Composition Each 100gm Powder Contains:
Amoxicillin Sodium…10gm
Colistin Sulphate…500,00,000 IU
2019
Type of Form Form 5
100gm, 500gm, and 1000gm; As recommended by PRC
(MOH)
Me-too status VELLE MOXYCOL W.S. POWDER. Reg. No. 043592
dated 03-08-2021
Remarks of the Evaluator X  Approval of Oral Dry powder Penicillin section

for inspection dated 08-07-2021, 15-07-2021, 30-07-
2021 and 03-08-2021 for renewal of DML.
dated 07-05-2021 and conversion of Colistin sulphate from IU to grams.
Brand Name +Dosage Form + Amcolist 120 WSP
Strength
Colistin Sulphate…10,000,000 IU
2019
Type of Form Form 5
Pack size & Demanded Price 100gm and 1000gm; As recommended by PRC (MOH)
Me-too status Could not be confirmed in the applied strength.
Remarks of the Evaluator X  Approval of Oral Dry powder Penicillin section
firm.
 Fee Rs, 7500/- for revision of finished product
specifications.
 Provide conversion of Colistin sulphate from IU to
grams.
 Submission of conversion of Colistin sulphate from IU to grams.
Brand Name +Dosage Form + Bio-Bromox WSP
Strength
2019
Type of Form Form 5
Pack size & Demanded Price 1Kg; As recommended by PRC (MOH)
Me-too status Could not be confirmed in the applied strength.
firm.
specifications.
Brand Name +Dosage Form + Bio-Sipra WSP
Strength
Composition Each 1000gm Powder contains:
Spiramycin Adipate…75gm
Lincomycin HCl…25gm
2019
Pharmacological Group Antibiotic/ antiparasitic
Type of Form Form 5
Pack size & Demanded Price 500gm and 1Kg; As recommended by PRC (MOH)
Espira Powder of M/s Elegance Pharmaceuticals,
Me-too status
specifications.
Registration letter shall be issued after submission of fee of Rs.7500/- for revision /pre-approval
correction in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
Brand Name +Dosage Form + Bio-Erizine WSP
Strength
Erythromycin Thiocyanate…200mg
Sulfadiazine…150mg
Trimethoprim…30mg
2019
Pharmacological Group Antibiotic/ antiprotozoal
Type of Form Form 5
Could not be confirmed in the applied strength and
Me-too status
combination.
Remarks of the Evaluator X  Approval of Oral Dry powder section (veterinary)
confirmed vide panel inspection report for inspection
dated 08-07-2021, 15-07-2021, 30-07-2021 and 03-
08-2021 for renewal of DML.
firm.
specifications.
Brand Name +Dosage Form + Bio-Vesel E Liquid
Strength
Vitamin E Acetate (a-tocopherol) …200gm
Sodium (as sodium selenite)…0.25gm
2019
Pharmacological Group Antioxidant/ micronutrient
Type of Form Form 5
Pack size & Demanded Price 1000ml; As recommended by PRC (MOH)
Me-too status Could not be confirmed in applied strength.
Remarks of the Evaluator X  Oral liquid section (Veterinary) confirmed from
panel inspection report dated 05-12-2017 & 06-12-
2017 for grant of GMP certificate
firm.
specifications.
Applicant Lahore.
Brand Name +Dosage Form + Cepfur Sterile Powder for Injection
Strength
Composition Each vial contains:
Ceftiofur as Sodium…1gm
2019
Pharmacological Group Antibacterial (Cephalosporin)
Type of Form Form 5
Pack size & Demanded Price 1’s x 1gm; Decontrolled
Ceftiofur Sodium for Injection of M/s Mehran
Me-too status
International, Karachi (Reg. No. 049573)
35787178.
Decision: Deferred for approval of requisite manufacturing facility / section.
Applicant Lahore.
Brand Name +Dosage Form + Tagafon Plus WSP
Strength
Composition Each gm contains:
Trichlorfon…980mg
2019
Pharmacological Group Organophosphate insecticide
Type of Form Form 5
Pack size & Demanded Price 5gm, 10gm, 100gm, 500gm, and 1000gm; Decontrolled
Tri Gold WSP of M/s Attabak Pharma, Islamabad.(Reg.
Me-too status
No. 049700)
Remarks of the Evaluator X  Approval of Oral Powder Sachet (General) section
799925699434.
Brand Name +Dosage Form + Bio-Chlortiam WSP
Strength
Chlortetracycline HCl eq. to Chlortetracycline
Base…20gm
Tiamulin Hydrogen Fumarate eq. to Tiamulin
Base…36.45gm
2019
Pharmacological Group Antibiotics
Type of Form Form 5
Me-too status Could not be confirmed in applied strength.
Remarks of the Evaluator X  Oral dry powder section (Veterinary) confirmed
from panel inspection report dated 10-04-2019 & 23-
04-2019 for grant of GMP certificate
firm.
specifications.
Brand Name +Dosage Form + Peroxin Oral Solution
Strength
Pefloxacin Methanesulfonate 139.6gm eq. to Pefloxacin…
………100gm
2019
Pharmacological Group Quinolone antibiotic

Type of Form Form 5
Peperoxin Solution of M/s Hassan Brothers, Faisalabad
Me-too status
(Reg. No.082807)
specifications along with fee of Rs.7,500/- vide
challan No. 4378573184.
Decision: Approved with innovator’s specifications with pack size upto 1Liter.
Brand Name +Dosage Form + Kiltix Solution
Strength
Deltamethrin…25mg
2019
Pharmacological Group Ecto paracitiside
Type of Form Form 5
Deltafaar Liquid of M/s Izfaar Pharmaceutical Industries,
Me-too status
Lahore. (Reg. No.097876)
 Both “oral liquid” and “topical liquid” dosage forms
are mentioned on form-5 while “topical liquid” is
mentioned throughout the dossier; upon clarification
regarding applied dosage form, the firm has
submitted that “Kiltix is prescribed for external use
i.e. spray, dip charging or topping up.” However, the
firm could not submit evidence of approval of topical
liquid section.(The firm has submitted approval
letter dated ------2015 for Liquid General section
challan No. 889074619.
Shortcomings:
 Evidence of approval of Topical Liquid (General)
section / panel inspection report for renewal of
DML
Decision: Deferred for confirmation of approval of Topical Liquid (General) section.
Brand Name +Dosage Form + Allout Oral Suspension
Strength
Albendazole…10gm
Ivermectin…0.2gm

2019
Type of Form Form 5
Thunder Drench of M/s Star Laboratories (Pvt) Ltd,
Me-too status
Lahore (Reg. No. 058941)
 Oral Liquid (General) section confirmed vide
challan No. 7415731515.
Decision: Approved with innovator’s specifications and change of brand name with pack size
upto 1Liter.
Brand Name +Dosage Form + Phantom Oral Powder
Strength
Phenoxymethylpenicillin…293mg eq. to
Phenoxymethylpenicillin Potassium…325mg
2019
Pharmacological Group Penicillin antibiotic
Type of Form Form 5
100gm, 200gm, 500gm, 1Kg, 2.5Kg, 5Kg, 10Kg, 20Kg,
and 25Kg; Decontrolled
Phenoxypen Water Soluble Powder of M/s Tec-Man
Me-too status
International, Rawalpindi. (Reg. No.081303)
 Oral Powder (penicillin) section confirmed vide
panel inspection dated 10-03-2022, 21-04-2022 and 09-
05-2022 report for approval of DML.
 Initially, Phenoxymethylpenicillin…293mg/G was
mentioned in label claim on form-5 while
Phenoxymethylpenicillin…325mg/G was mentioned
in master formula; upon clarification the firm has
submitted the correct formulation as mentioned
below:
Each gram contains:
Phenoxymethylpenicillin…293mg eq. to
Phenoxymethylpenicillin Potassium…325mg
 Firm has submitted fee Rs. 30,000/- vide challan No.
55764995 for revision of master formula.
Decision: Approved with USP specifications with pack size upto 1Kg.
Brand Name +Dosage Form + Spalcodin Oral Powder
Strength

Composition Each Kg powder contains:
Amoxicillin Trihydrate…100gm
Spectinomycin Sulphate…50gm
2019
Type of Form Form 5
50gm, 100gm, 500gm, 1Kg, 5Kg, 10Kg, 10Kg, and 20Kg;
Decontrolled
Spectomox-L oral powder of M/s Grand Pharma (Pvt)
Me-too status
Ltd., Islamabad. (Reg. No.102077)
Remarks of the Evaluator X  Oral Powder (penicillin) section confirmed vide
panel inspection dated 10-03-2022, 21-04-2022 and 09-
05-2022 report for approval of DML.
 Initially, Spectinomycin sulphate…50gm/Kg was
mentioned in label claim on form-5 while
Spectinomycin …50gm/Kg was mentioned in master
formula, upon clarification the firm has submitted the
correct master formula along with fee Rs. 7500/- vide
challan No. 021673791141
Shortcomings:
 Balance fee Rs. 22,500/- for revision of master
formula.
Decision: Approved with innovator’s specifications upto pack size 1Kg and with following
label claim:
Each Kg powder contains:
Spectinomycin Sulphate…50gm
Registration letter shall be issued after submission of differential fee of Rs.22500/- for
revision of formulation as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Bio-Brom Plus Liquid
Strength
Menthol…40mg
2019
Pharmacological Group Mucolytic/anaesthetic
Type of Form Form 5
Pack size & Demanded Price 500ml and 1000ml; As recommended by PRC (MOH)
Bromo-Plus Liquid of M/s Elegance Pharmaceutical,
Me-too status
Rawalpindi (Reg. No.073917)
dated 03-08-2021
Remarks of the Evaluator X  Approval of oral liquid (General) section
dated 08-07-2021, 15-07-2021, 30-07-2021 and 03-

Decision: Approved with innovator’s specifications. Firm shall submit fee of Rs.7500/- for
revision of finished product specifications as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
Brand Name +Dosage Form + Bio-Brom Liquid
Strength
Menthol…20mg
2019
Pharmacological Group Mucolytic/anaesthetic
Type of Form Form 5
Pack size & Demanded Price 500ml and 1000ml; As recommended by PRC (MOH)
Bromotin Liquid of M/s Elegance Pharmaceuticals,
Me-too status
dated 03-08-2021
 Approval of oral liquid (General) section
dated 08-07-2021, 15-07-2021, 30-07-2021 and 03-
dated 07-05-2021.
Brand Name +Dosage Form + Bio-Diver WSP
Strength
Composition Each Kg powder contains:
Sulfadimerazine Sodium…860gm
Diaveridine…105gm
2019
Pharmacological Group Antibiotic/antiprotozoal
Type of Form Form 5
100gm sachets and 1000gm jars; As recommended by PRC
(MOH)
Fulstop Water Soluble Powder of M/s Prix Pharmaceutica
Me-too status
(Pvt) Ltd., Lahore. (Reg. No. 049524)
dated 03-08-2021
dated 08-07-2021, 15-07-2021, 30-07-2021 and 03-
dated 07-05-2021.
Brand Name +Dosage Form + Bio-Bromicta WSP
Strength

Composition Each 100gm Powder Contains:
Tartaric Acid…15gm
2019
Type of Form Form 5
500gm and 1000gm jars; As recommended by PRC
(MOH)
Bromotaric Water Soluble Powder of M/s ICI Pakistan
Me-too status
Limited, Lahore. (Reg. No. 089822)
dated 03-08-2021
dated 08-07-2021, 15-07-2021, 30-07-2021 and 03-
dated 07-05-2021.
Brand Name +Dosage Form + Bio-Nicta WSP
Strength
Nicotinamide…0.32gm
Menadione Bisulfite…0.115gm
Potassium Citrate…18gm
Sodium Citrate…12gm
Vitamin B1…0.03gm
Vitamin B2…0.015gm
Vitamin C…1.10gm
2019
Type of Form Form 5
Pack size & Demanded Price 1000gm jar; As recommended by PRC (MOH)
Anti Gumbo Powder of M/s Leads Pharma (Pvt) Ltd.,
Me-too status
dated 03-08-2021
dated 08-07-2021, 15-07-2021, 30-07-2021 and 03-
dated 07-05-2021.
145. Name and address of manufacturer / M/s International Pharma Labs, Raiwind Road, Bhobtian
Applicant Chowk, Defence Road, 1-Km Towards Kahna, Lahore.
Brand Name +Dosage Form + I-Doxybrotyl Powder
Strength

2019
Type of Form Form 5
100gm, 250gm, 500gm, 1Kg, 2.5Kg, 5Kg, 10Kg, 25Kg;
As per DPC
Tylobid Powder of M/s Attabak Pharmaceuticals,
Me-too status
Remarks of the Evaluator X Dry Powder (General and Antibiotic) section verified
from panel inspection report for renewal of DML based on
inspection dated 13-01-2022.
8314936611.
Decision: Approved with innovator’s specifications with pack size of upto 1Kg.
Brand Name +Dosage Form + I-Tyldoxbro powder
Strength
Bromhexine HCl…0.5gm
2019
Type of Form Form 5
As per DPC
B.G. Doxit Water Soluble Powder of M/s Biogen Pharma,
Me-too status
Rawat. (Reg. No. 080147)
77086925.
 Provided conversion of Colistin Sulphate from MIU
to grams
Colistin Sulphate 10MIU= 500mg
Brand Name +Dosage Form + I-Mentfort V Solution
Strength
Peppermint…40gm
Eucalyptus…50gm
Menthol…50gm
Vitamin A…30000000 IU
2019
Pharmacological Group Decongestant
Type of Form Form 5
Pack size & Demanded Price 100ml, 200ml, 250ml, 500ml, and 1000ml; As per DPC
Fenetime Oral Solution of M/s Biogen Pharma,Rawat.
Me-too status
(Reg. No. 063815)
Remarks of the Evaluator X Syrup General section verified from panel inspection
report for renewal of DML based on inspection dated 13-01-
2022.
4581537301.
 Provided conversion of Vitamin A from MIU to
grams
Vitamin A Palmitate 1.7MIU/gram
Brand Name +Dosage Form + I-Florfen Solution
Strength
Florfenicol…100mg
2019
Type of Form Form 5
Fenlor Solution of M/s Selmore Pharmaceutical (Pvt) Ltd.,
Me-too status
2022.
7329167371.

Brand Name +Dosage Form + I-Mentbro Powder
Strength
Menthol………...…4mg
2019
Type of Form Form 5
As per DPC
Tusnil 2% Powder of M/s Univet Pharmaceuticals,
Me-too status
19176907.
Brand Name +Dosage Form + Jalc Plus Powder
Strength
Composition Each gram Contains:
Aspirin…200mg
Vitamin C…600mg
Sodium Chloride…35mg
Sodium Citrate…7mg
2019
Pharmacological Group Electrolytes/ Anti-inflammatory
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1Kg, 2.5Kg, 5Kg; As per DPC
Electro Ras Plus W/S Powder of M/s Attabak
Me-too status
X
Remarks of the Evaluator Dry Powder (General and Antibiotic) section verified
1980709737.
Shortcomings:
 Justification/ clarification regarding compatibility of
Acetylsalicyclic Acid with Vitamin C

Brand Name +Dosage Form + I-Bromen Solution
Strength
Menthol…20mg
2019
Type of Form Form 5
Bromotin Liquid of M/s Elegance Pharmaceuticals,
Me-too status
2022.
2171964718.

Brand Name +Dosage Form + I-Neocin 72 Powder
Strength
Composition Each kg contains:
2019
Pharmacological Group Anti-bacterial
Type of Form Form 5
As per DPC
Nobineo Oral Powder of M/s Noble Pharma Mirpur Azad
Me-too status
Kashmir (Reg. No. 058726)
3463918581.
Brand Name +Dosage Form + I-Bromoride Powder
Strength

2019
Type of Form Form 5
As per DPC
Bromex Water Soluble Powder of M/s Attabak
Me-too status
Pharmaceutical Islamabad (Reg. No. 058891)
51521673
Brand Name +Dosage Form + I-Tyldoxclin Powder
Strength
2019
Type of Form Form 5
As per DPC
DOT Powder of M/s Attabak Pharmaceutical Islamabad
Me-too status
(Reg. No. 069628)
X
Remarks of the Evaluator Dry Powder (General and Antibiotic) section verified
16025569.
Brand Name +Dosage Form + I-Neoflor Powder
Strength
Florfenicol…100gm
Oxytetracycline HCl…300gm
2019
Type of Form Form 5
As per DPC
Noxyflor Water Soluble Powder of M/s Divine
Me-too status
Pharmaceuticals, Lahore. (Reg. No. 087584)
4573598960.
Brand Name +Dosage Form + I-NCS Powder
Strength
Chlortetracycline as HCl…200mg
2019
Type of Form Form 5
As per DPC
NC STREP Powder of M/s Leads Pharma (Pvt) Ltd,
Me-too status
87528097.
Brand Name +Dosage Form + I-Colamox Powder
Strength
Spectinomycin as Sulphate…5gm
2019
Type of Form Form 5
As per DPC
AS-Plus Water Soluble Powder of M/s Attabak
Me-too status
Pharmaceutical Islamabad (Reg. No. 071063)
Remarks of the Evaluator X Penicillin Powder Oral section verified from panel
inspection report for renewal of DML based on inspection
dated 13-01-2022.
94440775.
to grams
Brand Name +Dosage Form + I-Lincomix Powder
Strength
2019
Type of Form Form 5
As per DPC
Licogrow-44 Oral Powder of M/s RAS Pharmaceuticals
Me-too status
(Pvt) Ltd., Multan. (Reg. No. 080157)
53199310.
Brand Name +Dosage Form + I-Tcolidox Powder
Strength
2019
Type of Form Form 5
As per DPC
Polydox-T Oral Powder of M/s Biogen Pharma, Rawat.
Me-too status
(Reg. No. 071019)
0587282826.
to grams
Brand Name +Dosage Form + I-Doxclin T Powder
Strength
2019
Type of Form Form 5
As per DPC
Doxyline Water Soluble Powder of M/s Inshal
Me-too status
Pharmaceutical Industries, Islamabad. (Reg. No. 075776)
587004436075.
to grams
Brand Name +Dosage Form + I-Enrocol B Solution
Strength
Enrofloxacin HCl…10gm
Bromhexine HCl…0.5%
2019
Pharmacological Group Antibacterial/Mucolytic
Type of Form Form 5
2022.
2060509181.
to grams
Shortcomings:
firm.
(generic / me-too status) along with registration number, brand name and name of firm.
Brand Name +Dosage Form + I-Enrocil Solution
Strength
Enrofloxacin HCl…20gm
Colistin Sulphate…4500000 IU
2019
Type of Form Form 5
Baxencol Liquid of M/s Baxter Pharmaceuticals, Karachi.
Me-too status
(Reg. No. 073975)
2022.
3472969037.
to grams

163. Name and address of manufacturer / M/s A & K Pharmaceuticals, 94-A, Punjab Small
Applicant Industrial Estate, Faisalabad.
Brand Name +Dosage Form + Lincos-P 11% Powder
Strength
Lincomycin Monohydrate…11gm
2019
Type of Form Form 5
10gm, 30gm, 100gm sachet, 250gm, 500gm, 1000gm
Pack size & Demanded Price white plastic jar with sealed cap, 2.5Kg, 5Kg, 10Kg, 25Kg
Bag; Decontrolled
LINC-11 Oral Powder of M/s Aptly Pharmaceuticals,
Me-too status
Remarks of the Evaluator X  Oral Dry Powder General (Vet) section confirmed
based on inspection dated 09-11-2018
8317407563.
Shortcomings:
 Latest cGMP inspection report (conducted within the
period of last three years)
Decision: Approved with innovator’s specification upto 1Kg pack size. Registration letter will
be issued after satisfactory GMP report by QA&LT Division within 3 years.
Brand Name +Dosage Form + Paramax-C Oral Powder
Strength
Paracetamol…2gm
Vitamin C…20gm
Calcium Carbonate…4.5gm
Magnesium Sulphate…3.5gm
Potassium Chloride…4gm
2019
Pharmacological Group Analgesic, stress controller
Type of Form Form 5
Bag; Decontrolled
SPIN-C Powder of M/s Leads Pharma (Pvt) Ltd.,
Me-too status
3027034788.
Shortcomings:
Brand Name +Dosage Form + Tybrox 10 Oral Powder
Strength
Doxycycline as HCl…200gm
2019
Type of Form Form 5
Pack size & Demanded Price white plastic jar with sealed cap, 2.5Kg, 5Kg, 10Kg Bag;
Decontrolled
Biodox Forte Oral Powder of M/s Bio-Oxime
Me-too status
Pharmaceuticals, Faisalabad. (Reg. No. 079874)
Oral Dry Powder General (Vet) section confirmed
52422053801.
Shortcomings:
Decision: Approved with innovator’s specification. Registration letter will be issued after
satisfactory GMP report by QA&LT Division within 3 years.
Brand Name +Dosage Form + Levosin 30 Powder
Strength
Levamisole HCl…300mg
2019
Type of Form Form 5
Bag; Decontrolled
Levamin Powder of M/s Univet Pharmaceutical,
Me-too status
Rawalpindi (Reg. No. 069644)

Firm has revised finished product specification from
21508620062.
Shortcomings:
Brand Name +Dosage Form + Xedo-80 Oral Powder
Strength
Doxycycline Hyclate Eq. To Doxycycline…800mg
2019
Type of Form Form 5
100gm, 250gm, 500gm, 1000gm white plastic jar with
sealed cap, 2.5Kg, 5Kg, 10Kg, 25Kg Bag; Decontrolled
Doxyral 80% Water Soluble Powder of M/s Orient Animal
Me-too status
Health (Pvt.) Limited, Karachi (Reg. No. 082504)
Remarks of the Evaluator X Oral Dry Powder General (Vet) section confirmed
49519388154.
Shortcomings:
Brand Name +Dosage Form + Xedo-575 Oral Powder
Strength
2019
Type of Form Form 5
sealed cap, 5Kg, 10Kg, 25Kg Bag; Decontrolled
Cydox Oral Powder of M/s ISIS Pharmaceuticals &
Me-too status
Chemical Works, Karachi (Reg. No. 063525)
 Oral Dry Powder General (Vet) section confirmed

Firm has revised finished product specification from
92204362913.
Shortcomings:
Brand Name +Dosage Form + Coolant Oral Powder
Strength
Paracetamol…20gm
Vitamin C…5gm
Potassium Carbonate…12.5gm
Sodium Bicarbonate…12.5gm
Vitamin E…12.5gm
2019
Pharmacological Group Analgesic, Stress controller
Type of Form Form 5
Bag; Decontrolled
Para CE Oral Powder of M/s Biogen Pharma, Rawat Chak
Me-too status
Beli Road, Rawat (Reg. No. 063812)
60066419.
Shortcomings:
Brand Name +Dosage Form + Marisil 300 Water Soluble Powder
Strength
Oxytetracycline HCl…150mg
Florfenicol…150mg
2019
Type of Form Form 5
sealed cap, 2.5Kg, 5Kg, 10Kg, 25Kg Bag; Decontrolled

Oxy-Floro Water Soluble Powder of M/s Intervac (Pvt)
Me-too status
Ltd., Sheikhupura. (Reg. No. 080726)
304691490887.
Shortcomings:
Decision: Approved with innovator’s specification upto 1Kg Pack size. Registration letter will
Brand Name +Dosage Form + Amanta-10 Powder
Strength
2019
Type of Form Form 5
Bag; Decontrolled
Amandin Water Soluble Powder of M/s Fizi
Me-too status Pharmaceuticals and Chemical Laboratories, Lahore. (Reg.
No. 103819)
 Oral Dry Powder General (Vet) section confirmed
69840062651.
Shortcomings:
Brand Name +Dosage Form + Amanta-98 Powder
Strength
2019
Type of Form Form 5

Bag; Decontrolled
Hansredin 98% Powder of M/s D-Haans Pharmaceuticals
Me-too status and Chemical Laboratories, Bhimber, Azad Kashmir.
(Reg. No. 102207)
44192889100.
Shortcomings:
Brand Name +Dosage Form + Amicin 60 Powder
Strength
2019
Pharmacological Group Aminoglycoside Antibiotic
Type of Form Form 5
Pack size & Demanded Price white plastic jar with sealed cap, 5Kg, 10Kg, 25Kg Bag;
Decontrolled
Neocin-S Water Soluble Powder of M/s Alina Combine
Me-too status
Pharmaceuticals (Pvt) Ltd., Karachi. (Reg. No. 069625)
42620044349.
Shortcomings:
Brand Name +Dosage Form + Amicin 70 Powder
Strength
Neomycin Sulphate…70%
2019
Pharmacological Group Aminoglycoside Antibiotic
Type of Form Form 5
Decontrolled
Neocin Powder of M/s Leads Pharma (Pvt) Ltd.,
Me-too status
97960066.
Shortcomings:
Brand Name +Dosage Form + Tybrox-2 Oral Powder
Strength
2019
Type of Form Form 5
Pack size & Demanded Price white plastic jar with sealed cap, 2.5Kg, 5Kg, 10Kg Bag;
Decontrolled
Multidox Oral Powder of M/s Hawk Bio Pharma (Pvt)
Me-too status
Ltd., Rawat, Islamabad. (Reg. No. 078395)
4964231175.
Shortcomings:
Decision: Approved with innovator’s specification upto pack size 1Kg. Registration letter will
Brand Name +Dosage Form + Tydox-70 C Water Soluble Powder
Strength

2019
Type of Form Form 5
Pack size & Demanded Price white plastic jar with sealed cap, 5Kg, 10Kg Bag;
Decontrolled
Fit Respi Water Soluble Powder of M/s D-Maarson
Me-too status
from panel inspection report for renewal of DML based
on inspection dated 09-11-2018
61931658826.
Shortcomings:
 Provide conversion of Colistin Sulphate from MIU to
grams.
be issued after satisfactory GMP report by QA&LT Division within 3 years and conversion of
Colistin Sulphate from MIU to grams.
Brand Name +Dosage Form + Tydox-70 Powder
Strength
2019
Type of Form Form 5
Decontrolled
Tylobid Powder of M/s Attabak Pharmaceuticals,
Me-too status
with the fee of Rs. 7,500/- via deposit slip no 16751795.
Shortcomings:
Latest cGMP inspection report (conducted within the
Brand Name +Dosage Form + Tydox 65 Powder
Strength
2019
Type of Form Form 5
Decontrolled
TB-DOX Powder of M/s Attabak Pharmaceuticals,
Me-too status
Remarks of the Evaluator X Oral Dry Powder General (Vet) section confirmed from
panel inspection report for renewal of DML based on
inspection dated 09-11-2018
Shortcomings:
Brand Name +Dosage Form + Levosin 20 Powder
Strength
Levamisole HCl…20gm
2019
Type of Form Form 5
Decontrolled
Leva Tech -20 W/S Powder of M/s Islamabad
Me-too status
Pharmaceutical Products Islamabad (Reg. No. 022757)
 Oral Dry Powder General (Vet) section confirmed from
panel inspection report for renewal of DML based on
4538055413.
Shortcomings:
Brand Name +Dosage Form + Chlortet Plus Water Soluble Powder
Strength
Chlortetracycline HCl…80gm
2019
Type of Form Form 5
Decontrolled
NB-CIN Water Soluble Powder of M/s D-Maarson
Me-too status
Pharmaceuticals, Islamabad (Reg. No. 078359)
Shortcomings:
Brand Name +Dosage Form + Tydox-30 GP Oral Liquid
Strength
Guaifenesin…20gm
Aminophylline…8gm
2019
Pharmacological Group Antibiotic/ Bronchodilator
Type of Form Form 5
30ml, 60ml, 100ml, 150ml, 250ml, 450ml, 500ml, 1000ml
Pack size & Demanded Price plastic bottle with sealed cap, 2.5liter, 5liter, 10liter, 25liter
Can; Decontrolled
Tyco-G Oral Liquid of M/s Attabak Pharmaceuticals,
Me-too status
 Oral Liquid General section confirmed from panel
inspection report for renewal of DML based on
21104761677.
Shortcomings:
Decision: Approved with innovator’s specification upto 1Liter pack size. Registration letter
Brand Name +Dosage Form + Marisil 20 Liquid
Strength
Florfenicol…20gm
2019
Pharmacological Group Antibiotic/ Bronchodilator
Type of Form Form 5
30ml, 60ml, 100ml, 250ml, 500ml, 1000ml plastic bottle
Pack size & Demanded Price with sealed cap, 2.5liter, 5liter, 10liter, 25liter Can;
Decontrolled
Floricol Liquid of M/s Inshal Pharmaceutical Industries,
Me-too status
Remarks of the Evaluator X  Oral Liquid General section confirmed from panel
inspection report for renewal of DML based on
7941017727.
Shortcomings:
Decision: Approved with innovator’s specification upto 1Liter pack size. Registration letter
Applicant Lahore.
Brand Name +Dosage Form + Danocin 2.5% injection
Strength
Danofloxacin (as mesylate) …25mg
Diary No. Date of R& I & fee Duplicate dossier submitted which was confirmed from
R&I section, DRAP
Dy.No 4162 dated 02-02-2018 Rs.20,000/- dated 29-01-
2018 (Duplicate fee challan attached)
Pharmacological Group Quinolone antibiotic
Type of Form Form 5
Dflox Injection (50ml) of M/s Selmore Pharmaceuticals,
Me-too status
Remarks of the Evaluator X  Approval of Liquid injectable (veterinary) section
 The firm has revised finished product specifications
from Manufacturer’s to “as per innovator’s
specifications” without submitting fee.
Decision: Approved with innovator’s specifications. The firm shall submit fee of Rs. 7500/- for
pre-approval change in product specifications as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021. Moreover, fee shall be verified as per procedure adopted by the Registration
Board in its 285th meeting.
Item No. XIV: Agenda of Evaluator-IX
184. Name and address of manufacture / M/s Amros Pharmaceuticals, A-96, S.I.T.E., North
Applicant Karachi (DML No. 000406)
Tablet Section (General)
Brand Name + Dosage Form and POZER 15MG/1MG Tablet.
Strength
Composition Each Film Coated tablet contains;
Pioglitazone Hydrochloride ……………. 15 mg
Glimepiride …………………. 1 mg
Dairy No. date of R &I fee Dy. No. 15366 dated 07.03.2019. Fee paid vide voucher
No. 0836419 dated 07.03.2019
Pharmacological Group Drugs used in diabetes, combinations of oral blood glucose
lowering drugs;
ATC code: A10BD06.
Type of form Form 5-A
Finished product specifications Innovator Specifications.
Pack size and Demand Price 10’s As per SRO
Approval status of product in Not available in applied strength. In RRA the combination
Reference Regulatory Authorities is available with 30 mg strength of Pioglitazone.
Me-too-status Piozer-G 15/1 Tablets Reg. No. 055163
M/s Hilton Pharma (Pvt) Ltd,, 13, Sector-15, Korangi
Industrial Area, Karachi
GMP Status Inspection report 28.10.2022 is submitted. GMP certificate
valid till 27.10.2024 is submitted.
Remark of the Evaluator. i. Application shall be submitted on prescribed form
i.e Form 5, currently Form 5-A is submitted.
ii. Monograph of Pioglitazone and Glimepiride
Tablets is present in USP, the firm shall revise
specifications as per pharmacopoeia specifications.
iii. The approval status of the product with the same
strength (i.e. Pioglitazone (as HCl) 15 mg and
Glimepiride…. 1 mg) in RRA shall be submitted.
iv. Label claim needs revision as Pioglitazone is
added in its salt form i.e. HCl. Also submit
requisite fee (full fee) for change of salt form.
Decision: Deferred for following;
 Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were adopted by the Registration Board in its 275th meeting.
 Submission of correct Form-5, revised specifications as per Pharmacopoeia and label
claim declaring the strength of Pioglitazone in terms of base along with relevant fee for
correction/pre-approval change in product specifications, label claim and Form 5 as per
notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021
185. Name and address of manufacture / M/s Amros Pharmaceuticals, A-96, S.I.T.E., North Karachi
Applicant (DML No. 000406)
Brand Name + Dosage Form and POZER 15MG/2MG Tablet.
Strength
Pioglitazone Hydrochloride ……………. 15 mg
Glimepiride …………………. 2 mg
No. 0836415 dated 07.03.2019
lowering drugs;
ATC code: A10BD06.
Pack size and Demand Price As per SRO
Approval status of product in Not available in applied strength. In RRA the combination
Reference Regulatory Authorities is available with 30 mg strength of Pioglitazone.
iii. The approval status of the product with the same
strength (i.e. Pioglitazone (as HCl) 15 mg and
Glimepiride…. 2 mg) in RRA shall be submitted.
iv. Label claim needs revision as Pioglitazone is
 Submission of correct Form-5, revised specifications as per Pharmacopoeia and label
claim declaring the strength of Pioglitazone in terms of base along with relevant fee for
Brand Name + Dosage Form and POZER 30/4MG Tablet.
Strength
Composition Each tablet contains;
Pioglitazone Hydrochloride …. 30 mg
Glimepiride ……………………….. 4 mg
No. 0836420 dated 07.03.2019
lowering drugs;
ATC code: A10BD06.
Approval status of product in Duetact (Pioglitazone hydrochloride and glimepiride)
Reference Regulatory Authorities tablets (30 mg/4 mg uncoated tablet)
FDA Approved
iii. Label claim needs revision as Pioglitazone is
Decision: Deferred for submission of correct Form-5, revised specifications as per Pharmacopoeia
and label claim declaring the strength of Pioglitazone in terms of base along with relevant fee for
Brand Name + Dosage Form and GLIME 2.0 mg Tablet
Strength
Composition Each Film coated Tablet contains;
Glimepiride ……….. 2 mg
No. 0829587 dated 02.03.2019, endorsed on 07.03.2019
Pharmacological Group Oral blood glucose lowering drugs: Sulfonamides, urea
derivatives.
ATC Code: A10BB12
Finished product specifications Innovator Specifications
Pack size and Demand Price As per SRO and DRAP Policy.
Approval status of product in Glimepiride 2 mg Tablets
Reference Regulatory Authorities MHRA Approved.
Me-too-status Amaryl tab 2 mg Reg. No. 019568
M/s Sanofi-Aventis Pakistan Ltd. Plot No. 23, Sector 22
Korangi Industrial Area Karachi.
ii. Monograph of Glimepiride Tablets is present in
pharmacopoeias; the firm shall revise
Submit requisite fee for the changes.
iii. The product applied is a coated tablet, evidence of
approval of coated tablet in RRA is required.
and label claim declaring the dosage form as film coated tablet along with relevant fee for
Strength
derivatives.
ATC Code: A10BB12
Strength
derivatives.
ATC Code: A10BB12
Brand Name + Dosage Form and SPAS-CIBALGIN Tablets
Strength
Composition Each Film Coated Tablet Contains;
Propyphenazone Ph. Eur. …….220 mg
Hexahydroadiphenine HCl M.S ……20 mg
Pharmacological Group Analgesic and antispasmodic.
Could not be confirmed from ATC/DDD system.
Type of form Form-5
Finished product specifications Innovator’s Specifications.
Pack size and Demand Price 10x10’s As per DRAP policy.
Approval status of product in Could not be confirmed.
Reference Regulatory Authorities
Me-too-status Prohyd Tablet
M/s Genome Pharmaceuticals (Pvt.) Ltd. Plot No. 16/1,
Phase No. IV, Industrial Estate Hattar.
Remark of the Evaluator. i. Provide details of the innovator along with
evidence of approval in RRA.
ii. Provide ATC Code for the drug combination
applied.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
Brand Name + Dosage Form and AMCOLAX TABLET
Strength
Bisacodyl …… 5 mg
Pharmacological Group Contact Laxative
ATC Code: A06AB02
Type of form Form-5
Finished product specifications USP Specifications.
Pack size and Demand Price 2 x 10’s. As per DRAP Policy.
Approval status of product in Bisacodyl 5mg Tablets
Reference Regulatory Authorities Gastro-resistant Tablets
MHRA Approved
Me-too-status DULCOLAX 5mg TAB
M/s Merck (Pvt.) Ltd. 7-Jail Road, Quetta
Remark of the Evaluator. i. The product of innovator is gastro-resistant
formulation and USP monograph is of delayed
release tablets. The applied product is film coated.
Justification or correction is required.
Decision: Approved as per following label claim:
“Each delayed release tablet contains;
Bisacodyl …… 5 mg”
 The registration letter shall be issued after submission of revised formulation label and
full fee for pre-approval changes by the firm for gastro-resistant/delayed release tablets
Brand Name + Dosage Form and Amenitec 5 mg Tablet
Strength
Composition Each Tablet Contains
Enalapril Maleate …………… 5 mg
Pharmacological Group ACE inhibitors, plain
ATC Code: C09AA02
Finished product specifications USP Specifications
Pack size and Demand Price As per SRO. As per DRAP policy.
Approval status of product in Enalapril Maleate 5 mg Tablets
Reference Regulatory Authorities MHRA Approved
Me-too-status Cardiotec 5 mg Tablet Reg. No. 010030
M/s Wilsons Pharmaceuticals (Pvt.) Ltd. Islamabad
Remark of the Evaluator. i. The application is submitted on Form-5A.
Application shall be submitted on correct form i.e.
Form 5.
Decision: Deferred for submission of correct Form-5 along with full fee as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and Amenitec 20 mg Tablet
Strength
ATC Code: C09AA02
Approval status of product in Enalapril Maleate 20 mg Tablets
Me-too-status Cardiotec 20mg Tablet Reg. No. 007706

Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and Metro 200mg Tablet
Strength
Composition Each film coated tablet Contains;
Metronidazole B.P. …… 200mg
Pharmacological Group Agents Against Amoebiasis And Other Protozoal
Diseases, Nitroimidazole Derivatives.
ATC Code: P01AB01
Approval status of product in Metronidazole 200 mg Tablets
Reference Regulatory Authorities Film-coated tablets
MHRA Approved
Me-too-status Flagyl Tablets 200mg Reg. No. 000910

Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and Sartan 20mg tablet
Strength
Composition Each film coated tablet contains
Telmisartan …………… 20 mg
Pharmacological Group Angiotensin II Antagonists, plain.
ATC Code: C09CA07.
Type of form Form-5A
Approval status of product in Telmisartan 20mg Glenmark film-coated tablets
Me-too-status Telsartan Tablet 20mg Reg. No. 045976
M/s CCL Pharmaceuticals (Pvt) Ltd., 62 Industrial Estate
Kot Lakhpat Lahore
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
ATC Code: C09CA07.
Approval status of product in Telmisartan 40mg Glenmark film-coated tablets
Me-too-status Tesart 40mg Tablets Reg. No. 045082
M/s Bosch Pharmaceuticals, Karachi.
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AMDOMET 250 mg Tablet
Strength
Composition Each Film Coated Tablet contains;
Methyldopa ……… 250 mg
Pharmacological Group antiadrenergic agents
ATC Code: C02AB
Type of form Form-5
Pack size and Demand Price As per DRAP policy
Approval status of product in Methyldopa 250mg Tablets BP
Reference Regulatory Authorities Film coated tablets
MHRA Approved.
Me-too-status Aldomet 250 mg Tablet Reg. No. 000311
M/s OBS (Pvt.) ltd.Karachi
Remark of the Evaluator. i. On page 75 of the dossier, definition of Gastro-
resistant Bisacodyl Tablets is given. This need
correction along with provision of Requisite fee.
Decision: Approved.
Brand Name + Dosage Form and VERINE 200 mg Tablet
Strength
Composition Each Fim Coated Tablet Contains;
Mebeverine HCl………….. 200 mg
Pharmacological Group Drugs For Functional Gastrointestinal DisordersSynthetic
Anticholinergics, Esters With Tertiary Amino Group
ATC Code: A03AA04
Type of form Form-5-A
Finished product specifications Manufacturer’s Specifications
Approval status of product in Could not be found.
Reference Regulatory Authorities The one provided by the applicant is a modified release
capsule of Mebeverine.
Me-too-status Could not be verified.

Form 5
ii. The firm shall submit Approval status of product in
Reference Regulatory Authorities.
iii. The firm shall submit evidence of me too of same
strength.
 Submission of correct Form-5 along with full fee.
status) alongwith registration number, brand name and name of firm.
authorities/agencies which were adopted by the Registration Board in its 275th
meeting.
Brand Name + Dosage Form and MLODI 5mg Tablet
Strength
Amlodipine Besylate …………. 5 mg
Pharmacological Group Dihydropyridine derivatives
ATC Code: C08CA01
Finished product specifications In-House Specifications (Page 104)
Pack size and Demand Price As per DRAP Policy
Approval status of product in Norvasc 5 mg Tablets (amlodipine besylate equivalent to 5
Reference Regulatory Authorities mg of amlodipine per tablet).
FDA Approved
Me-too-status Norvasc Tablet 5mg Reg. No. 011825
M/s Pfizer Pakistan Ltd., B-2-SITE Karachi.
Form 5
ii. The specifications of the applied product are
present in pharmacopoeia and specifications
applied are mfg specifications. This needs
correction along with requisite fee.
iii. The product of innovator is not film coated and the
applied product is film coated. Justification is
required.
Decision: Deferred for submission of correct Form-5, revised drug product specifications as per
Pharmacopoeia and revised master formulation as per innovator product along with full fee as
per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and FEBUX 40mg Tablet
Strength
Composition Each Tablet contains;
Febuxostat …………….. 40 mg
Dairy No. date of R &I fee Dy. No. 15371 dated 07.03.2019. Fee Rs. 20,000/- paid
vide voucher No. 0836425 dated 07.03.2019, endorsed on
07.03.2019
Pharmacological Group Preparations inhibiting uric acid production
ATC Code: M04AA03
Finished product specifications In-house Specifications
Pack size and Demand Price As per SRO and DRAP Policy
Approval status of product in Uloric tablets 40 mg.
Reference Regulatory Authorities FDA Approved.
Me-too-status Adenuric Tablet 40mg Reg. No. 067033
M/s S.J & G. Fazul Ellahie (Pvt) Ltd., E/46 S.I.T.E
Karachi.
Form 5
ii. The specifications of the finished product is
mentioned different at multiple points, on page 88
of the dossier In-house specifications are
mentioned and on page 127 innovator’s
specifications are mentioned. This need to be
clarified.
Decision: Deferred for submission of correct Form-5 and drug product specifications along with
full fee as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and FEBUX 80mg Tablet
Strength
Febuxostat …………….. 80 mg
Pharmacological Group Preparations inhibiting uric acid production
ATC Code: M04AA03
Finished product specifications In-house Specifications (Page 88)
Pack size and Demand Price As per SRO and DRAP Policy
Approval status of product in Uloric tablets 80 mg.
Me-too-status Adenuric Tablet 80mg Reg. No. 067034
M/s S.J & G. Fazul Ellahie (Pvt) Ltd., E/46 S.I.T.E
Karachi.
Form 5
ii. The specifications of the finished product is
mentioned different at multiple points, on page 88
of the dossier In-house specifications are
mentioned and on page 127 innovator’s
specifications are mentioned. This need to be
clarified.
Decision: Deferred for submission of correct Form-5 and drug product specifications along with
full fee as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and MEBIN 500 mg Tablet
Strength
Composition Each Tablet Contains;
Mebendazole ……. 500 mg
Pharmacological Group ANTINEMATODAL AGENTS, Benzimidazole derivatives
ATC Code: P02CA01
Approval status of product in VERMOX 500 mg Chewable Tablets
Reference Regulatory Authorities FDA Approved
Me-too-status Vermox 500 mg Reg. No. 009082
M/s Aspin Pharma (Pvt) Ltd. Karachi.

Form 5
ii. The strength of 500mg mebendazole is approved in
RRA in chewable form, the applied product is not
chewable. Clarification is required.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021 for revision of formulation and label as per
innovator product as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and APRIL 1.25 mg Tablet
Strength
Composition Each film Coated Tablet Contains;
Ramipril …………… 1.25 mg
Pharmacological Group ACE Inhibitors, plain,
ATC Code: C09AA05
Approval status of product in Ramipril 1.25 mg Tablets
Me-too-status Mevlon 1.25mg Tablet Reg. No. 045336
M/s Helix Pharma (Pvt) Ltd., A/56 SITE Mangopir
Karachi
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021 as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
Brand Name + Dosage Form and APRIL 5 mg Tablet
Strength
Ramipril………….. 5 mg
ATC Code: C09AA05
Finished product specifications BP/USP Specifications
Approval status of product in Delix 5mg Tablets (Hoescht MR, Germany)
Reference Regulatory Authorities Bfarm Germany Approved
Me-too-status Tritace 5mg Tablets Reg. No. 019565

Form 5
dated 07-05-2021.
Brand Name + Dosage Form and APRIL 10 mg Tablet
Strength
Ramipril………….. 10 mg
ATC Code: C09AA05
Approval status of product in Ramipril 10 mg Tablets
Me-too-status Tritace 10mg Tablets Reg. No. 045390
M/s Sanofi-Aventis Pakistan Ltd., Plot No. 23 Sector 22
Korangi Industrial Area Karachi
Form 5
dated 07-05-2021.
Brand Name + Dosage Form and VENTO 2 mg Tablet
Strength
Albuterol as sulfate ………… 2 mg
Pharmacological Group Selective beta-2-adrenoreceptor agonists,
ATC Code: R03CC02
Approval status of product in Salbutamol Tablets BP 2mg
Reference Regulatory Authorities Each tablet contains 2.4mg salbutamol sulfate equivalent to
2mg salbutamol.
MHRA Approved
Me-too-status BRONKAL-2 TAB Reg. No. 011638
Each tablet contains:- SULBUTAMOL SULPHATE 2mg
M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi
Form 5.
dated 07-05-2021.
Brand Name + Dosage Form and GABA 300 mg Tablet
Strength
Gabapentin …………… 300 mg
Pharmacological Group Other antiepileptics
ATC Code: N03AX12
Approval status of product in Evidence of approval of Strength of 300 mg in tablet
Reference Regulatory Authorities dosage form in RRA could not be verified.
Me-too-status Gabapen Tablet 300 mg Reg. No. 060555
M/s Batala Pharmaceuticals Gujranwala
Form 5
ii. Strength of tablet in application at S. No. 4, page 4
is mentioned as 100 mg. It needs correction along
with submission of requisite fee.
iii. Evidence of approval of Strength of 300 mg in tablet
dosage form in RRA is required.
Decision: Deferred for submission of correct Form-5, clarification of applied strength along
with full fee as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and VASTCOR 10 mg tablet
Strength
Simvastatin…………. 10 mg
Pharmacological Group HMG CoA reductase inhibitors
ATC Code: C10AA01
Approval status of product in Simvastatin 10 mg Tablets Reg. No. 027757
Reference Regulatory Authorities Each film-coated tablet contains Simvastatin,10mg
MHRA Approved.
Me-too-status Atcol 10 mg Tablets
M/s Atco Laboratories B-18 S.I.T.E Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and GALNAS 50 Tablet
Strength
Vildagliptin ……… 50 mg
Pharmacological Group BLOOD GLUCOSE LOWERING DRUGS, EXCL.
INSULINS, Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC Code: A10BH02
Finished product specifications In-House Specifications
Approval status of product in Galvus 50 mg Tablet
Me-too-status Galvus Tablets 50 mg Reg. No. 059038
M/s Novartis Pharma (Pakistan) Ltd. Karachi.
Form 5
ii. The applied product is film coated. The firm shall
provide evidence of film coated tablets vildagliptin
50 mg approved in RRA.
 Revision of Formulation as per innovator product.
Brand Name + Dosage Form and IRBES 75 mg Tablet
Strength
Irbesartan……………….. 75 mg
Pharmacological Group Angiotensin-II Antagonists, Plain.
ATC Code: C09CA04
Approval status of product in Irbesartan 75 mg film-coated tablets
Me-too-status Irecon Tablet 75 mg Reg. No. 039725
M/s Barret Hodgson Pakistan Karachi.
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and HARTAN 160 mg Tablet
Strength
Valsartan ………. 160 mg
Pharmacological Group Angiotensin II receptor blockers (ARBs), plain
ATC Code: C09CA03
Approval status of product in Valsartan 160 mg Film-Coated Tablets
Me-too-status Nuval 160mg Tablet Reg. No. 066837
M/s PharmEvo (Pvt) Ltd., A-29 North West Industrial
Zone Light Industrial Zone Port Qasim Karachi.
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and OPRAM 20.0 MG Tablet
Strength
Escitalopram as Oxalate ………… 20 mg
07.03.2019
Pharmacological Group Antidepressants, Selective serotonin reuptake inhibitors.
ATC Code: N06AB10
Approval status of product in Cipralex 20 mg film-coated tablets
Me-too-status Cipralex Fim-Coated Tablets 20 mg Reg. No. 059035
M/s Lundbeck Pakistan (Pvt.) Ltd. Karachi.

Form 5
ii. The strength of tablet at S. No 4 of page 4 is
mentioned as 5 mg. This needs to be corrected
along with submission of requisite fee.
Decision: Deferred for submission of submission of correct Form-5 along with full fee.
 Submission of proper formulation and strength.
Brand Name + Dosage Form and VISTA 5mg Tablet
Strength
Rosuvastatin as calcium …. 5mg
07.03.2019
ATC Code: C10AA07
Finished product specifications Innovator’s Specifications
Approval status of product in Rosuvastatin DAWA 5,10, 20 and 40 mg Film-Coated
Reference Regulatory Authorities Tablets
MHRA Approved.
Me-too-status Hyporose 5mg tablet Reg. No. 050413
M/s Mediate Pharmaceutical (Pvt.) Ltd. Karachi
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and VENTO 8.0mg Extended-Release Tablets
Strength
Composition Each extended release tablet contains;
Albuterol as Sulphate …….. 8 mg
07.03.2019
Pharmacological Group Selective beta-2-adrenoreceptor agonists
ATC Code: R03CC02
Approval status of product in VOSPIRE ER Albuterol sulfate eq 8 mg base
Me-too-status Inhalerin SR Tab 8mg Reg. No. 029556
M/s Werrick Pharmaceuticals Islamabad.
Form 5
ii. The strength of tablet at S. No. 4, page 4 is
mentioned as 2mg/tablet. This needs to be
corrected along with submission of requisite fee.
 Submission of proper formulation and strength.
Brand Name + Dosage Form and MPROVEL 150mg/12.5mg Tablet
Strength
Irbesartan ………….….150 mg
Hydrochlorothiazide …12.5 mg
07.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics
ATC Code: C09DA04
Approval status of product in Irbesartan Hydrochlorothiazide 150 mg/12.5 mg film
Reference Regulatory Authorities coated tablets
MHRA Approved
Me-too-status Arbi-D 150/12.5 tablet Reg. No 073772
M/s PharmEvo (Pvt.) Ltd. Karachi.
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and MPROVEL 300mg/25mg Tablet
Strength
Irbesartan ………….….300 mg
Hydrochlorothiazide …25 mg
07.03.2019
ATC Code: C09DA04
Approval status of product in Irbesartan Hydrochlorothiazide 300 mg/25 mg film coated
Reference Regulatory Authorities tablets
MHRA Approved
Me-too-status Arbi-D 300mg/25mg tablet Reg. No 088175
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and CO-HARTAN 160 mg/12.5 mg Tablet
Strength
Valsartan……………… 160 mg
Hydrochlorothiazide….. 12.5 mg
07.03.2019
ATC Code: C09DA03
Approval status of product in Valsartan-Hydrochlorothiazide 160mg/12.5mg Film-
Reference Regulatory Authorities Coated tablets.
MHRA Approved
Me-too-status Nuval –D 160/12.5mg Tablet Reg. No.066839
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
218.Name and address of manufacture / M/s Amros Pharmaceuticals, A-96, S.I.T.E., North Karachi
Brand Name + Dosage Form and CO-APRIL (2.5mg/12.5mg)
Strength (Ramipril/Hydrochlorothiazide) Tablet
Ramipril (BP)…………….. 2.5 mg
Hydrochlorothiazide (BP)….12.5 mg
Dairy No. date of R &I fee Dy. No. 1357 dated 07.03.2019. Fee Rs. 20,000/- paid vide
voucher No. 0835453 dated 07.03.2019, endorsed on
07.03.2019
Pharmacological Group ACE inhibitors and diuretics
ATC Code: C09BA05
Type of form Form-5
Finished product specifications Manufacturers Specifications.
Pack size and Demand Price 28’s. As per SRO.
Approval status of product in Reference ALTACE HCT Tablet
Regulatory Authorities Health Canada Approved.
Me-too-status Triatec HCT 2.5/12.5mg Tablet Reg. No. 043011
M/s Sanofi-Aventis Pakistan Ltd. Karachi.
Remark of the Evaluator. i. Specifications of Finished Product are mentioned
as Manufacturers specifications.
Brand Name + Dosage Form and GLIME-M 2.0 mg / 500 mg Tablet
Strength
Glimepiride ……………… 2.0 mg
Metformin HCl …………. 500 mg
07.03.2019
Pharmacological Group Combinations of oral blood glucose lowering drugs,
metformin and sulfonylureas
ATC Code: A10BD02
Approval status of product in Reference Could not be confirmed.
Regulatory Authorities
Me-too-status Getformin Tablet 2mg+500mg Reg. No. 044126
M/s Getz Pharma (Pvt) Ltd. Karachi.

220. i. The
R application is submitted on Form-5A.
emark of the Evaluator. Application shall be submitted on correct form i.e.
Form 5
ii. Approval of product in Reference Regulatory
Authorities is required.
meeting.
Brand Name + Dosage Form and NEXET-D 60mg/120mg Tablet
Strength
Fexofenadine Hydrochloride USP …………60 mg
Pseudoephedrine Hydrochloride USP …….. 120 mg
07.03.2019
Pharmacological Group pseudoephedrine, combinations
ATC Code: R01BA52
Type of form Form-5
Finished product specifications Amros Specifications
Pack size and Demand Price 1 x 10’s As per SRO
Approval status of product in Reference ALLEGRA-D Fexofenadine hydrochloride and
Regulatory Authorities pseudoephedrine hydrochloride caplets (Sustained-
Release) Caplets, 60 mg & 120 mg, Oral.
The product approved by Health Canada is a Sustained
release formulation.
Me-too-status Fexo-D Tablets Reg. No. 031607
M/s Hilton Pharma (Pvt.) Ltd.
Remark of the Evaluator. i. Approval of product in Reference Regulatory
authorities
Brand Name + Dosage Form and FORMIN 50/500mg Tablet

Strength
Metformin HCl ……….500 mg
Vildagliptin …………..50 mg
07.03.2019
Pharmacological Group Combinations of oral blood glucose lowering drugs.
ATC Code: A10BD08
Approval status of product in Reference Galvumet Film Coated Tablets (50 mg vildagliptin and 500
Regulatory Authorities mg metformin hydrochloride)
Swissmedic Approved
Me-too-status Galvus Met 50/500mg tablet Reg. No. 078106
M/s Novartis Pharma (Pakistan) Ltd. Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and FORMIN 50/850mg Tablet
Strength
Metformin HCl ……….850 mg
Vildagliptin …………..50 mg
07.03.2019
ATC Code: A10BD08
Approval status of product in Reference Galvumet Film Coated Tablets (50 mg vildagliptin and 850
Regulatory Authorities mg metformin hydrochloride)
Swissmedic Approved
Me-too-status Vilfor 50/850mg tablet Reg. No. 106507
M/s Hi-Medic Pharmaceuticals (Pvt) Ltd Lahore
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
224. Name and address of M/s Amros Pharmaceuticals, A-96, S.I.T.E., North Karachi
manufacture / Applicant (DML No. 000406)
Brand Name + Dosage Form and LO-HARD 50mg/12.5mg Tablet
Strength
Composition Each film coated tablet contains;
Losartan Potassium ……… 50 mg
Hydrochlorothiazide……… 12.5 mg
07.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics.
ATC Code: C09DA01
Approval status of product in LOSARTAN POTASSIUM
Reference Regulatory /HYDROCHLOROTHIAZIDE 50MG /12.5MG
Authorities TABLETS (Film Coated)
MHRA Approved.
Me-too-status Thaitan-H 50mg/12.5mg Tablet Reg. No. 104788
M/s Jaens Pharmaceutical Industries (Pvt.) Ltd. Lahore.
Form 5.
Decision: Deferred for submission of correct Form-5 along with full fee as per
Brand Name + Dosage Form and LO-HARD 100mg/12.5mg Tablet
Strength
Composition Each film coated tablet contains;
Losartan Potassium ……… 100 mg
Hydrochlorothiazide……… 12.5 mg
07.03.2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and diuretics.
ATC Code: C09DA01
Approval status of product in COZAAR-COMP 100MG/12.5MG FILM-COATED
Reference Regulatory TABLETS
Authorities MHRA Approved.
Me-too-status Losmart-H 100mg/12.5mg Tablet Reg. No. 100198
M/s Scilife Pharma (Pvt.) Ltd. Karachi.
Form 5.
Capsule Section (General)
Brand Name + Dosage Form and COXIB 100mg Capsule
Strength
Composition Each Capsule Contains;
Celecoxib ………… 100 mg
07.03.2019
Pharmacological Group ANTIINFLAMMATORY AND ANTIRHEUMATIC
PRODUCTS, NON-STEROIDS, Coxibs.
ATC Code: M01AH01
Approval status of product in CELEBREX 100-mg capsules
Reference Regulatory FDA Approved
Authorities
Me-too-status Celbex Capsules 100mg Reg. No. 028694
M/s Getz Pharma (Pvt) Ltd., 29-30 Sector 27 Korangi
Industrial Area Karachi
Form 5.
ii. In product summary dosage form is mentioned as
“oral 100mg per tablet”
 Submission of proper formulation and strength of applied product.
Oral Liquid Section (General)
Brand Name + Dosage Form and VERINE 10mg/ml Oral Solution
Strength
Composition Given for film coated tablets. (Page 110)
07.03.2019
Pharmacological Group Synthetic anticholinergics, esters with tertiary amino
group.
ATC Code: A03AA04
Approval status of product in Mebeverine hydrochloride 50mg/5ml Oral Suspension
Reference Regulatory MHRA Approved
Authorities

Form 5
ii. Label claim is given for tablet, not for oral liquid.
iii. Formulation approved in RRA is a suspension with
label claim of 50mg/5ml. The applied label claim
is different and dosage form is also different (oral
solution). Evidence is required for applied
formulation in RRA.
iv. Evidence of Me-too product is also required.
meeting.
 Submission of proper formulation, label and specifications of the applied product.
Brand Name + Dosage Form and Active-DM Syrup (Dextromethorphen 10 mg,
Strength Pseudoephedrine HCl 30 mg)
Composition Each 5ml contains;
Dextromethorphan Hydrobromide….... 10 mg
Pseudoephdrine Hydrochloride …….. 30 mg
Triprolidine hydrochloride……….…. 1.25 mg
07.03.2019
Pharmacological Group Other antihistamines for systemic use
ATC code: R06AX07
Finished product specifications Not mentioned.
Pack size and Demand Price 60 ml, as per SRO
Approval status of product in Multi-Action ACTIFED Dry Coughs (oral Liquid)
Reference Regulatory MHRA approved
Authorities
Me-too-status Actifed DM Cough Syrup Reg. No. 007817
M/s GSK west Warf Karachi.
Remark of the Evaluator. i.The application is submitted on Form-5A. Application
shall be submitted on correct form i.e. Form 5.
ii. Specifications of finished product are not
mentioned in the application.
 Submission of proper specifications.
Brand Name + Dosage Form ZINEDAL 5mg Syrup
andStrength
Composition Each 5 ml contains
Cetirizine dihydrochloride …………. 5 mg
07.03.2019
Pharmacological Group Piperizine derivatives
ATC Code: R06AE07
Approval status of product in Cetirizine Hydrochloride 5 mg/5 ml Oral Solution
Reference Regulatory MHRA Approved.
Authorities
Me-too-status Rigix Oral Solution Reg. No. 020308
M/s AGP (Pvt) Ltd. Karachi.
Form 5
ii. In me-too and RRA Cetrizine hydrochloride is

approved, not dihydrochloride. Label and
formulation shall be corrected along with
submission of requisite fee.
meeting. Or,
 Correction for salt of API as per innovator product.
Brand Name + Dosage Form and HYDROSIN-DM Syrup (diphenhydramine 5mg +
Strength Dextromethorphan 6.25) per 5 ml
Composition Each 5 ml contains;
Diphenhydramine…………5 mg
Dextromethorphan………. 6.25 mg
07.03.2019
Pharmacological Group diphenhydramine, combinations.
ATC Code: R06AA52
Pack size and Demand Price 120 mL, 450 mL. As per SRO
Approval status of product in Could not be verified for the applied strength
Reference Regulatory
Authorities
Me-too-status Cofex DM Syrup Reg. No 040625
M/s Wilson’s Pharmaceuticals, 387-388 Sector I-9
Industrial Area Islamabad
Form 5.
ii. The RRA approved formulations have salt forms in

their label claim, (Dextromethorphan
Hydrobromide, Diphenhydramine Hydrochloride).
iii. The reference for this strength could not be
verified in RRA.
meeting.
Brand Name + Dosage Form and VENTO SYRUP 2mg/5ml
Strength
Composition Each 5 mL contains;
Albuterol as Sulfate …………. 2 mg
07.03.2019
ATC Code: R03CC02
Pack size and Demand Price 120 mL, As per SRO
Approval status of product in Ventolin Syrup
Authorities
Me-too-status Bronkal Syrup Reg. No. 013894
M/s Atco Laboratories Karachi.
valid till 27.10.2024 is submitted..
Form 5
ii. pharmacopoeial specifications of the applied
formulation are available, specifications shall be
revised to pharmacopoeial specs.
 Revision of Specifications.
Oral Dry Powder Suspension Section (General)
Brand Name + Dosage Form and ANZAL 100 mg Oral Solution
Strength
Composition Each 5 mL contains;
Linezolid……. 100 mg
07.03.2019
Pharmacological Group Other antibacterials.
ATC Code: J01XX08
Approval status of product in Linezolid 100mg/5ml granules for oral suspension
Authorities
Me-too-status Nezkil Dry Suspension Reg. No. 067037
M/s S.J. & G. Fazul Ellahi (Pvt.) Ltd. Karachi
Form 5
ii. Applied product is oral solution, the formulation of
linezolid is in form of granules for oral suspension.
 Submission of correct formulation as per innovator product.
Brand Name + Dosage Form and METRO 200 mg/5ml Suspension
Strength
Composition Each 5mL contains;
Metronidazole base……………... 200 mg
07.03.2019
Pharmacological Group Antibacterial for Systemic use.
ATC Code: J01XD01
Approval status of product in Metronidazole 200 mg/5 ml Oral Suspension
Reference Regulatory Each 5 ml of oral suspension contains metronidazole
Authorities benzoate equivalent to 200 mg of metronidazole
MHRA Approved.
Me-too-status Diagyl Suspension Reg. No. 020229
M/s Swiss Pharmaceuticals (Pvt) Ltd., A-159 SITE North
Karachi Scheme No. 33 Karachi.
Form 5
ii. Salt is not mentioned in label claim.
 Correction for salt of API as per innovator product.
Brand Name + Dosage Form and BENARIL SYRUP
Strength
Composition Each 5 ml contains;
Ammonium Chloride……. 131.5 mg
Chloroform… 22 mg
Menthol……. 1 mg
Sodium Citrate …….55 mg
Diphenhydramine …..13.5 mg
07.03.2019
Pharmacological Group diphenhydramine, combinations
ATC Code: R06AA52
Pack size and Demand Price 120mL, 450mL. As per SRO
Approval status of product in Could not be verified.
Authorities

Form 5
ii. Salt of diphenhydramine is not mentioned.
iii. Evidence of approval of formulation in RRA is
required.
iv. Evidence of approval of me-too is required.

meeting.
 Correction for salt of API.
Oral Dry Powder Suspension Section (General)
Brand Name + Dosage Form and AMCIN-C GRANULES For Oral Solution 75mg/ 5ml
Strength
Composition Label claim is given for capsule.
07.03.2019
Pharmacological Group MACROLIDES, LINCOSAMIDES AND
STREPTOGRAMINS, Lincosamides
ATC Code: J01FF01
Approval status of product in Cleocin FOR SOLUTION;ORAL
Reference Regulatory FDA Approved.
Authorities
Me-too-status Could not be confirmed.

Form 5
ii. Label claim of Capsule is given
iii. Evidence of Me-too product is required.
 Submission of proper label claim.
Brand Name + Dosage Form and BALIN 50 MG Capsule
Strength
Pregabalin …………..50 mg
07.03.2019
ATC Code: N03AX16
Pack size and Demand Price 14’s. As per SRO
Approval status of product in Lyrica® 50 mg hard capsules
Authorities
Me-too-status Gabica 50 mg Capsule Reg. No. 048725
M/s Getz Pharma (Pvt) Ltd Karachi
Form 5
Strength
07.03.2019
ATC Code: N03AX16
Approval status of product in Lyrica® 150 mg hard capsules
Authorities
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AMIN-C CAPSULE 300mg
Strength
Composition Each Capsule contains;
Clindamycin as HCl…………….. 300 mg
07.03.2019
STREPTOGRAMINS, Lincosamides
ATC Code: J01FF01
Approval status of product in Clindamycin 75, 150 and 300 mg Capsules, Hard.
Authorities
Me-too-status Greenlin-300 Capsules Reg. No. 052448
M/s Evergreen Pharmaceuticals Lahore.
Form 5
Cream / Ointment Section (General)
Brand Name + Dosage Form and NITRA 20mg/g Cream

Strength
Composition Miconazole Nitrate 2.0 %
07.03.2019
Pharmacological Group ANTIFUNGALS FOR TOPICAL USE, Imidazole and
triazole derivatives.
ATC Code: D01AC02
Finished product specifications BP Specifications
Pack size and Demand Price 10 gm, 20 gm. As per SRO
Approval status of product in Daktarin 2% Cream
Authorities
Me-too-status Myconit Cream Reg. No. 009936
M/s EPLA Laboratories (Pvt) Ltd. Karachi.
Form 5
ii. Label claim of tablet is given instead of cream.
iii. Strength needs to be correct to %w/w.
 Submission of proper label claim, formulation and specifications.
Brand Name + Dosage Form and COOL GEL
Strength
Composition Contains;
Lignocaine………………..…..0.6% W/W
Cetylpyridinium Chloride …. 0.02% W/W
Menthol ………………..….. 0.06 % W/W
Eucalyptol ………….………....0.1% V/W
Ethanol………………………....33% V/W
07.03.2019
Pharmacological Group Stomatological Preparation,
ATC code: A01AD11
Pack size and Demand Price 10 gm, 20 gm. As per SRO
Approval status of product in Could not be verified, more ingredients are used than
Reference Regulatory provided reference.
Authorities
Me-too-status Could not be verified, more ingredients are added than
given me-too
Form 5
ii. Evidence of RRA approval is required.
iii. Evidence of me-too is required.
meeting.
Injectable Section (General)
Brand Name + Dosage Form and AMROKET 30 MG INJECTION (Ampoule)
Strength (For toll manufacturing)
Composition Each Ampoule Contains;
Ketorolac tromethamine ………. 30 mg
07.03.2019
PRODUCTS, NON-STEROIDS, Acetic acid derivatives
and related substances.
ATC Code: M01AB15
Pack size and Demand Price 1x1, as per SRO.
Approval status of product in Ketorolac trometamol 30mg/ml Solution for Injection
Authorities
Me-too-status Ketometa 30mg Injection Reg. No. 108436
M/s Lahore Chemical & Pharmaceutical Works Lahore.
Form 5.
ii. Volume of ampoule should be mentioned. Revise
label claim accordingly along with requisite fee.
 Revision of label claim as per innovator product.
Brand Name + Dosage Form and AM-TOP 40mg Infusion
Strength
Composition Each Infusion Contains;
Pantoprazole as Sodium sesquihydrate …. 40 mg
07.03.2019
Pharmacological Group Proton Pump Inhibitor
ATC Code: A02BC02
Pack size and Demand Price 10 infusions, As per SRO
Approval status of product in Infusion could not verified, powder for infusion is MHRA
Reference Regulatory approved.
Authorities
Me-too-status Could not be verified for infusion.

Remark of the Evaluator. i.The application is submitted on Form-5A.
Form 5
ii. Route of administration is mentioned as oral, needs
correction.
iii. Clarify whether product is infusion or powder for
infusion.
iv. Provide evidence of section approval for general
vial dry powder filling.
v. If product is in infusion form, provide evidence of
RRA approval and Me-too status. Also mention
volume of infusion in label claim
 Submission of correct Form-5 having proper details of product applied along with full
fee.
 Evidence of approval of required manufacturing facility of “Dry powder Injection”
Section from CLB.
meeting.Correction for salt of API.
Brand Name + Dosage Form and XAMIC 500mg Injection
Strength
Composition Each Injection Contains;
Tranexamic Acid…… …. 500 mg
07.03.2019
Pharmacological Group ANTIHEMORRHAGICS
B02A ANTIFIBRINOLYTICS, Amino Acids
ATC Code: B02AA02
Pack size and Demand Price 2x 10’s. As per SRO
Approval status of product in Cyklokapron Injection, 500mg/5ml Solution for injection
Reference Regulatory MHRA approved.
Authorities
Me-too-status Transamin –INJ Reg. No. 010452
M/s Hilton Pharma (Pvt) Ltd. Karachi.
Form 5
ii. Route of Administration is mentioned as oral,
needs correction.
iii. Mention volume of ampoule and also revise label
accordingly.
 Revision of label as per innovator product.
Brand Name + Dosage Form and ANZAL 400 mg per 200 ml Infusion.
Strength
Composition Each 200 ml Contains;
Linezolid…… …. 400 mg
07.03.2019
Pharmacological Group Other antibacterials.
ATC Code: J01XX08
Approval status of product in Zyvox 2 mg/ml solution for infusion, 300 ml infusion bags
Reference Regulatory contain 600 mg linezolid.
Authorities MHRA Approved
Me-too-status Nezkil 200 mg Infusion, Reg. No. 048802
M/s S.J. & G. Fazul Ellahi (Pvt.) Ltd. Karachi
valid till 27.10.2024 is submitted..
Form 5
ii. Route of Administration is mentioned as oral,
needs correction.
iii. The product approved in RRA has strength of
600mg/300ml and have volume of 300 ml, whereas
applied product is 400mg/200ml. Reference of
RRA approval of applied product is required.
 Submit proper details about intended route of administration.
meeting.
Brand Name + Dosage Form AMPITOR 10mg Tablet
andStrength
Atorvastatin as Calcium …..10mg
Dairy No. date of R &I fee Dy. No. 15257 dated 07.03.2019. Fee paid Rs. 20000/-
vide Slip No. 0818375 dated 07.03.2019
Pharmacological Group HMG CoA reductase inhibitors.
ATC Code: C10AA05
Approval status of product in Lipitor 10mg, 20mg, 40mg 80mg
Reference Regulatory USFDA Approved.
Authorities
Me-too-status Lipitor Tablet 10mg Reg. No. 023620
M/s Pfizer Laboratories Karachi.
ii. Monograph of applied product is available in USP
and applied specifications are innovator’s.
Justification or change of specifications is required
Brand Name + Dosage Form and AMPITOR 20mg Tablet
Strength
ATC Code: C10AA05
Authorities
Brand Name + Dosage Form and AMPITOR 40mg Tablets.
Strength
ATC Code: C10AA05
Authorities
Brand Name + Dosage Form and VERINE 200mg Capsule.
Strength
Mebeverine HCl ….200 mg
group.
ATC Code: A03AA04
Pack size and Demand Price As per SRO.
Approval status of product in Mebeverine 200 mg modified release capsules (mebeverine
Reference Regulatory Authorities hydrochloride) - PL 35533/0095
MHRA Approved.
Me-too-status Maravine 200mg Capsules Reg. No. 1088112
M/s MTI Medical (Pvt.) Ltd. Lahore.
Remark of the Evaluator. i. Pellets Source: M/s Vision Pharmaceuticals.
ii. Application shall be submitted on prescribed form
iii. The formulation mentions pellets will be used, and
label claim does not depict this. Evidence of RRA
is also of modified release capsules which is not
mentioned in label claim. Label claim needs to be
revised accordingly along with submission of
requisite fee (full fee).
249.
meeting.
Brand Name + Dosage Form and GABA 100mg Tablet
Strength
Gabapentin …100mg
Pharmacological Group Other antiepileptics.
ATC Code: N03AX12
Authorities
Me-too-status Kendis Tablet 100mg Reg. No. 049035
M/s Martin Dow Karachi.
ii. Evidence of RRA approval of product having
strength of 100mg in tablet form is required.
meeting.
Brand Name + Dosage Form and GABA 400mg Tablet
Strength
Gabapentin …400mg
Pharmacological Group Other antiepileptics.
ATC Code: N03AX12
Authorities
Me-too-status Kendis Tablet 400mg Reg. No. 049037
ii. Evidence of RRA approval of product is required.
meeting.
Brand Name + Dosage Form and METFOR 250mg Tablet
Strength
Metformin HCl ……. 250mg
Pharmacological Group Biguanides
ATC Code: A10BA02
Approval status of product in
Me-too-status Glucophage Tablet 250mg Reg. No. 013365
ii. The product approved in RRA is uncoated tablet.
Applied product is film coated. Justification or
correction along with submission of requisite fee is
required.
authorities/agencies which were adopted by the Registration Board in its 275th meeting,
or,
 Revision of formulation as per innovator product.
Strength
vide Slip No. 0801924 dated 02.03.2019 endorsed on
07.03.2019
ATC Code: A10BA02
Approval status of product in Metformin 500, 850 and 1000mg film-coated tablets PL
Reference Regulatory Authorities 49230/0001-3
MHRA Approved.
Me-too-status Glucophage Tablet 500mg Reg. No. 000552
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
vide Slip No. 0818382 dated 02.03.2019 endorsed on
07.03.2019
ATC Code: A10BA02
MHRA Approved.
Me-too-status Exermet Tablet 850mg Reg. No. 098913
M/s Aspin Pharma Karachi..
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
ATC Code: A10BA02
MHRA Approved.
Me-too-status Glucophage Tablet 1Gm Reg. No. 025488
M/s Merck Quetta
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and VENTO 4.0mg Tablet
Strength
Albuterol as Sulfate …… 4mg
Pharmacological Group Selective beta-2-adrenoreceptor agonists, Salbutamol
ATC Code: R03AC02
Approval status of product in Salbutamol Tablets BP 4mg
Me-too-status Ventolin Tablet 2mg Reg. No. 000286
M/s GSK Karachi.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and MPROVEL 300mg/12.5mg Tablet
Strength
Irbesartan ………….. 300mg
Hydrochlorothiazide. 12.5mg
ATC Code: C09DA04
Approval status of product in Irbesartan and Hydrochlorothiazide Dr. Reddys 150
Reference Regulatory Authorities mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg Film-
coated Tablets (Irbesartan and hydrochlorothiazide) -
UK/H/2639/001-3/DC; PL 08553/0404-6
MHRA Approved.
Me-too-status Arbi-D 300/12.5 Reg. No. 073771
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AMCIN-C Capsule 150mg
Strength
Clindamycin as HCl…. 150mg
STREPTOGRAMINS
ATC Code: J01FF01
Approval status of product in Clindamycin 150 mg Capsules, Hard
Me-too-status Clidam 150mg Capsule Reg. No. 094956
M/s Parkar Pharma Kotri.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
07.03.2019
ATC Code: N03AX16
Approval status of product in Pregabalin Noumed 25, 50, 75, 100, 150, 200, 225 and
Reference Regulatory Authorities 300mg Capsules, hard (pregabalin) - PL 44041/0065-0072
MHRA Approved.
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
07.03.2019
ATC Code: N03AX16
Approval status of product in Pregabalin Noumed 25, 50, 75, 100, 150, 200, 225 and
Reference Regulatory Authorities 300mg Capsules, hard (pregabalin) - PL 44041/0065-0072
MHRA Approved.
GMP Status Inspection report dated 18.07.2018 is attached which is
older than 3 years.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and OPRAM 5.0mg Tablets
Strength
Escitalopram as Oxalate ….. 5mg
Pharmacological Group Selective serotonin reuptake inhibitors
ATC Code: N06AB10
Approval status of product in Escitalopram 5, 10 & 20mg Film-Coated Tablets (PL
Reference Regulatory Authorities 36390/0149-51; UK/H/5394/001-3/DC)
MHRA Approved.
Me-too-status Cipralex Film-Coated Tablet 5mg Reg. No. 059033
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and OPRAM 10mg Tablets
Strength
Escitalopram as Oxalate ….. 10mg
ATC Code: N06AB10
Approval status of product in Escitalopram 5, 10 & 20mg Film-Coated Tablets (PL
Reference Regulatory Authorities 36390/0149-51; UK/H/5394/001-3/DC)
MHRA Approved.
Me-too-status Cipralex Film-Coated Tablet 10mg Reg. No. 028467
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and POZER 30mg/2mg Tablet.
Strength
Composition Each tablet contains;
Pioglitazone (as Hydrochloride) …. 30 mg
No. 0836416 dated 07.03.2019
lowering drugs;
ATC code: A10BD06.
Approval status of product in Duetact (Pioglitazone hydrochloride and glimepiride)
Reference Regulatory Authorities tablets (30 mg/2 mg uncoated tablet)
FDA Approved
specifications as per pharmacopoeia specifications
Brand Name + Dosage Form and POZER 15mg/4mg Tablet.
Strength
Pioglitazone (as Hydrochloride) …. 15 mg
No. 0836417 dated 07.03.2019
lowering drugs;
ATC code: A10BD06.
Approval status of product in Cannot be verified for the applied strength.
specifications as per pharmacopoeia specifications
iii. Evidence of product approval in RRA with applied
strength is required.
meeting.
Brand Name + Dosage Form and CANDEN 8mg Tablet
Strength
Candesartan Cilexetil …. 8mg
ATC Code: C09CA06
Approval status of product in Candesartan cilexetil 4 mg, 8 mg, 16 mg and 32 mg
Reference Regulatory Authorities Tablets - PL 35084/0002-9; UK/H/4347 & 4626/001-4/DC
MHRA Approved.
Me-too-status Cansar 8mg Tablet Reg. No. 034306
M/s Pharmatec Pakistan Karachi.
i.e. Form 5, currently Form 5-A is submitted.
ii. Evidence of product approved in RRA is of
uncoated tablets, applied product is film coated.
Justification or correction is required along with
iii. Monograph of applied product is available in USP
and innovators specifications are applied.
Justification or change of specs is required along
meeting.
Brand Name + Dosage Form and CANDEN 16mg Tablet
Strength
Candesartan Cilexetil …. 16mg
ATC Code: C09CA06
Approval status of product in Candesartan cilexetil 4 mg, 8 mg, 16 mg and 32 mg
Reference Regulatory Authorities Tablets - PL 35084/0002-9; UK/H/4347 & 4626/001-4/DC
MHRA Approved.
Me-too-status Cansaar 16mg Tablet Reg. No. 033683
M/s Pharmatec Pakistan Karachi.
i.e. Form 5, currently Form 5-A is submitted.
ii. Evidence of product approved in RRA is of
uncoated tablets, applied product is film coated.
Justification or correction is required along with
iii. Monograph of applied product is available in USP
and innovators specifications are applied.
Justification or change of specs is required along
meeting.
Brand Name + Dosage Form and OPTADON Tablet 175mg/25mg
Strength
Propyphenazone …………. 175mg
Caffeine …………………. 25mg
Pharmacological Group OTHER ANALGESICS AND ANTIPYRETICS,
ATC Code: N02BB54
Type of form Form 5
Finished product specifications
Pack size and Demand Price 10x20’s. As per SRO.
Me-too-status Optalidon Tablet Reg. No. 002406
M/s GSK Karachi.
Remark of the Evaluator. i. Specifications of the Finished product are not
defined.
ii. Evidence of approval of applied formulation in
Reference Regulatory Authority as defined by
Registration Board is required.
 Submission of Specifications of finished product.
meeting.
Brand Name + Dosage Form and MATA PLUS Tablet 50mg/1000mg
Strength
Sitagliptin as Phosphate monohydrate…… 50mg
Metformin HCl………………………….... 1000mg
Pharmacological Group Combinations of oral blood glucose lowering drugs
ATC Code: A10BD07
Approval status of product in Janumet Tablets
Me-too-status Treviamet 50mg 1000mg Tablet Reg. No. 055444
M/s Getz Pharma Karachi.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and MATA PLUS Tablet 50mg/500mg
Strength
Sitagliptin as Phosphate monohydrate…… 50mg
Metformin HCl………………………….... 500mg
Pharmacological Group Combinations of oral blood glucose lowering drugs
ATC Code: A10BD07
Approval status of product in Janumet Tablets
Me-too-status Treviamet 50mg 500mg Tablet Reg. No. 055443
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AM-TOP 20mg Tablet
Strength
Composition Each Enteric Coated Tablet Contains;
Pantoprazole as sodium sesquihydrate…… 20mg
Pharmacological Group Proton pump inhibitors.
ATC Code: A02BC02
Pack size and Demand Price 10’s, As per SRO
Approval status of product in Pantoprazole 20 and 40mg gastro-resistant tablet; PL
Reference Regulatory Authorities 49445/0026; PL 49445/0027
MHRA Approved.
Me-too-status Neege 20mg Tablet Reg. No. 079531
M/s Sami Pharmaceuticals (Pvt) Ltd Karachi.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AM-TOP 40mg Tablet
Strength
Pantoprazole as sodium sesquihydrate…… 40mg
ATC Code: A02BC02
Finished product specifications USP Specifiations
Approval status of product in Pantoprazole 20 and 40mg gastro-resistant tablet; PL
Reference Regulatory Authorities 49445/0026; PL 49445/0027
MHRA Approved.
Me-too-status Neege 40mg Tablet Reg. No. 039504
M/s Sami Pharmaceuticals (Pvt) Ltd Karachi.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Topical Section (General/steroidal)
Brand Name + Dosage Form and BETNASOL Cream 0.1%
Strength
Composition Each gram contains;
Betamethasone (as valerate)….1.0mg
Pharmacological Group CORTICOSTEROIDS, DERMATOLOGICAL
PREPARATIONS, CORTICOSTEROIDS, PLAIN,
Corticosteroids, potent (group III)
ATC Code: D07AC01
Type of form Form 5
Pack size and Demand Price 10grams, As per SRO
Approval status of product in Betnovate Cream
Me-too-status Betnovate Cream Reg. No. 000256
M/s GSK Karachi.
Remark of the Evaluator. i. Pack sizes are not mentioned.
ii. %age strength is not mentioned.
Decision: Approved.
The registration letter shall be issued after submission of pack sizes along with fee for pre-
approval change.
Brand Name + Dosage Form and VENTO SYRUP 1mg/5ml
Strength
Composition Each 5ml Contains;
Albuterol as Sulfate …………1mg
Pharmacological Group Selective beta-2-adrenoreceptor agonists.
ATC Code: R03CC02
Pack size and Demand Price 120ml, As per SRO.
Me-too-status

ii. Salbutamol oral Solution monograph is available in
pharmacopoeia yet innovator’s specifications are
applied. Justification or correction along with
requisite fee is required.
iii. Evidence of product approval in RRA having
strength of Strength of 1mg/5ml is required.
iv. Evidence of me-too having strength of Strength of
1mg/5ml is required.
meeting..
Brand Name + Dosage Form and Hydrosin Syrup
Strength
Aminophylline…………..32mg
Diphenhydramine……….8mg
Ammonium Chloride …..30mg
Menthol…………………0.98mg
Pharmacological Group OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE
AIRWAY DISEASES, Xanthines
ATC Code: R03DA55
Finished product specifications Manufacturer’s Specifications.
Pack size and Demand Price 120ml, 450ml
Me-too-status Hydryllin Syrup Reg. No. 000016
M/s Searle Company Lahore.
ii. Evidence of product approval in RRA is required.
meeting.
Strength
ATC Code: C09CA03
Approval status of product in VALSARTAN 320 MG FILM-COATED TABLETS 320
Reference Regulatory Authorities MG FILM-COATED TABLET - PL 08553/0703
MHRA Approved
Me-too-status Valbar 320mg Tablet Reg. No. 086704
M/s Barrett Hodgson Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
ATC Code: C09CA03
Approval status of product in VALSARTAN 80 MG FILM-COATED TABLETS 80
Reference Regulatory Authorities MG FILM-COATED TABLET - PL 08553/0700
MHRA Approved
Me-too-status Valbar 80mg Tablet Reg. No. 086702
M/s Barrett Hodgson Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and CARBA 200mg Tablet
Strength
Carbamazepine ……. 200mg
Pharmacological Group ANTIEPILEPTICS, Carboxamide derivatives
ATC Code: N03AF01
Pack size and Demand Price 50’s, As per SRO
Approval status of product in CARBAMAZEPINE NOUMED 200 MG TABLETS - PL
Reference Regulatory Authorities 44041/0035.
MHRA Approved.
Me-too-status Mazetol Tablets Reg. No. 083998
M/s Cibex (Pvt.) Ltd. Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
strength
ATC Code: C09CA07.
Approval status of product in Telmisartan Glenmark Generics/ Telmisartan Glenmark 20
Reference Regulatory Authorities mg, 40 mg and 80 Film-coated Tablets - PL 25258/0024-
0026, PL 25258/0072 -0077; UK/H/2633/001-3/DC,
UK/H/4197-8/001-3/DC
MHRA Approved
Me-too-status Telsartan Tablet 80mg Reg. No. 045971
M/s CCL Pharmaceuticals (Pvt) Ltd., 62 Industrial Estate
Kot Lakhpat Lahore
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and METRO 400mg Tablet
Strength
Composition Each film coated tablet Contains;
Metronidazole B.P. …… 400mg
Pharmacological Group Agents Against Amoebiasis And Other Protozoal
Diseases, Nitroimidazole Derivatives.
ATC Code: P01AB01
Approval status of product in METRONIDAZOLE 400 MG FILM-COATED TABLETS
Reference Regulatory Authorities - PL 43461/0068
MHRA Approved
Me-too-status Flagyl Tablets 400mg Reg. No. 000827

Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and ANZAL 400mg Tablet
Strength
Linezolid…… 400mg
Pharmacological Group Other antibacterials
ATC Code: J01XX08
Finished product specifications Innovators’s Specifications.
Me-too-status Nezkil Tablet 400mg Reg. No. 034783
M/s SJ&G Fazul Ellahi Karachi.
Form 5
ii. Valid Evidence of RRA Approval is required for
strength of 400mg.
meeting.
Brand Name + Dosage Form and GLIME-M 1.0 mg / 500 mg Tablet
Strength
Glimepiride ……………… 1 mg
Metformin HCl …………. 500 mg
07.03.2019
Pharmacological Group Combinations of oral blood glucose lowering drugs,
metformin and sulfonylureas
ATC Code: A10BD02
Approval status of product in Could not be confirmed.
Me-too-status Getformin Tablet 1mg+500mg Reg. No. 044360

Form 5
ii. Approval of product in Reference Regulatory
meeting.
Brand Name + Dosage Form and VERINE 135 mg Tablet
Strength
Mebeverine HCl………….. 135 mg
Pharmacological Group Drugs For Functional Gastrointestinal DisordersSynthetic
Anticholinergics, Esters With Tertiary Amino Group
ATC Code: A03AA04
Approval status of product in Mebeverine hydrochloride 135mg Film-coated Tablets PL
Reference Regulatory Authorities 21880/0250-252; UK/H/7036-37/001/DC
MHRA Approved.
Me-too-status Spasfre Tablet 135mg Reg. No. 041750
M/s Himont Pharmaceuticals Lahore.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
07.03.2019
ATC Code: C10AA07
MHRA Approved.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
07.03.2019
ATC Code: C10AA07
MHRA Approved.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and NEXET 60mg Tablet
Strength
Fexofenadine HCl……..60mg
07.03.2019
Pharmacological Group Other antihistamines for systemic use.
ATC Code: R06AX26
Approval status of product in ALLEGRA 60mg Film-coated Tablets
Reference Regulatory Authorities USFDA Approved.
Me-too-status Fexet Tablet 60mg Reg. No. 029434
Form 5
ii. Evidence of product in RRA as uncoated tablet
could not be verified. Provide justification or
change label claim along with submission of
requisite fee.
meeting, or,
 Submission of revised formulation as per innovator product.
Strength
07.03.2019
ATC Code: R06AX26
287. Form-5A T
ype of form
288. USP Specifications.
F
inished product specifications
Approval status of product in Fexofenadine Hydrochloride 120 mg and 180 mg Film-
Reference Regulatory Authorities coated tablets PL 21880/0259-0260; UK/H/7053/002-
003/DC
MHRA Approved.
Form 5
requisite fee.
meeting, or,
 Submission of revised formulation and label as per innovator product.
Strength
07.03.2019
ATC Code: R06AX26
Approval status of product in Fexofenadine Hydrochloride 120 mg and 180 mg Film-
Reference Regulatory Authorities coated tablets PL 21880/0259-0260; UK/H/7053/002-
003/DC
MHRA Approved.
Form 5
requisite fee.
meeting, or,
 Submission of revised formulation and label claim as per innovator product.
Brand Name + Dosage Form and AMENITEC 10 mg Tablet
Strength
ATC Code: C09AA02
Approval status of product in Enalapril Maleate 5, 10, 20 mg Tablets (PL 44041/0012-
Reference Regulatory Authorities 0014)
MHRA Approved
Me-too-status Cardiotec 20 mg Tablet Reg. No. 007706
Form 5.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AMROFEC 75mg Tablet
Strength
Diclofenac Sodium …75mg
ATC Code: M01AB05
Type of form Form-5
Finished product specifications BP Specifications.
Pack size and Demand Price 2x10’s As per SRO.
Approval status of product in Could not be confirmed for strength of 75mg
Me-too-status Dicmaf 75mg Tablet Reg. No. 092669
M/s Mafins Pharma Karachi.
Remark of the Evaluator. i. Provide evidence of approval of product in RRA.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
derivatives.
ATC Code: A10BB12
pharmacopoeias; the firm shall revise specifications
as per pharmacopoeia specifications. Submit
requisite fee for the changes.
approval of coated tablet in RRA is required, or
change label along with submission of requisite fee.

meeting, or submission of formulation and label claim as per innovator product.
Brand Name + Dosage Form and MLODI 10mg Tablet
Strength
Amlodipine Besylate …………. 10 mg
Pharmacological Group Dihydropyridine derivatives
ATC Code: C08CA01
Pack size and Demand Price As per DRAP Policy
Approval status of product in Norvasc 10 mg Tablets (amlodipine besylate equivalent to
Reference Regulatory Authorities 5 mg of amlodipine per tablet).
FDA Approved
Me-too-status Norvasc Tablet 10mg Reg. No. 011826
Form 5
ii. The specifications of the applied product are
present in pharmacopoeia and specifications
applied are mfg specifications. This needs
correction along with requisite fee.
iii. The product of innovator is not film coated and the
applied product is film coated. Justification is
required.
Brand Name + Dosage Form and CO-HARTAN 80mg/12.5mg Tablet
Strength
Valsartan ……………..80mg
Hydrochlorothiazide …..12.5mg
ATC Code: C09DA03
Approval status of product in Valsartan-Hydrochlorothiazide 80mg/12.5mg,
Reference Regulatory Authorities 160mg/12.5mg and 160mg/25mg film-coated Tablets
(valsartan and hydrochlorothiazide) -PL 43801/0031-0033.
MHRA Approved.
Me-too-status Nuval-D 80/12.5mg Tablet Reg. No. 066838
M/s PharmEvo Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and CO-HARTAN 160mg/25mg Tablet
Strength
Valsartan ……………..160mg
Hydrochlorothiazide …..25mg
ATC Code: C09DA03
Approval status of product in Valsartan-Hydrochlorothiazide 80mg/12.5mg,
Reference Regulatory Authorities 160mg/12.5mg and 160mg/25mg film-coated Tablets
(valsartan and hydrochlorothiazide) -PL 43801/0031-0033.
MHRA Approved.
Me-too-status Nuval-D 160/25mg Tablet Reg. No. 066840
M/s PharmEvo Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
ATC Code: C09CA04
Approval status of product in Irbesartan 75 mg, 150 mg and 300 mg film-coated Tablets
Reference Regulatory Authorities (irbesartan) PL 43801/0007-0009
MHRA Approved.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Strength
ATC Code: C09CA04
Approval status of product in Irbesartan 75 mg, 150 mg and 300 mg film-coated Tablets
Reference Regulatory Authorities (irbesartan) PL 43801/0007-0009
MHRA Approved.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and CO-APRIL 5mg/25mg Tablet
Strength
Ramipril …………….. 5mg
Hydrochlorothiazide ….25mg
07.03.2019
Pharmacological Group ACE inhibitors and diuretics
ATC Code: C09BA05
Type of form Form-5
Approval status of product in ALTACE HCT Tablet DIN 02283174
Reference Regulatory Authorities Health Canada Approved.
Me-too-status Co-Triatec 5/25mg Tablet Reg. No. 043010
Remark of the Evaluator.
i. Specifications of Finished Product are mentioned
as Manufacturers specifications.
Brand Name + Dosage Form and APRIL 2.5 mg Tablet
Strength
Ramipril………….. 2.5 mg
ATC Code: C09AA05
Approval status of product in Delix 2.5 Tablets (Hoescht MR, Germany)
Reference Regulatory Authorities Bfarm Germany Approved
Me-too-status Tritace 2.5mg Tablets Reg. No. 019564
M/s Sanofi-Aventis Pakistan Ltd., Plot No. 23 Sector 22
Korangi Industrial Area Karachi
Form 5
ii. Evidence of coated tablet approval in RRA is
required.
Brand Name + Dosage Form and MEBIN 100 mg Tablet
Strength
Mebendazole ……. 100 mg
Pharmacological Group ANTINEMATODAL AGENTS, Benzimidazole derivatives
ATC Code: P02CA01
Approval status of product in VERMOX 100 MG TABLETS
Me-too-status Vermox 100 mg Reg. No. 004778
M/s Aspin Pharma (Pvt) Ltd. Karachi.
Form 5
ii. The strength of 500mg mebendazole is approved in
RRA in chewable form, the applied product is not
chewable. Clarification is required.
iii. The applied product is film coated, and product
approved in RRA is uncoated tablet. Clarification
or revision is required along with submission of
requisite fee.
Brand Name + Dosage Form and FORMIN 50mg/100mg Tablet
Strength
Vildagliptin …………. 50mg
Metformin HCl…….....1000mg
ATC Code: A10BD08
Approval status of product in Vildagliptin/Metformin 50 mg/1000 mg Film-coated
Reference Regulatory Authorities Tablets.
MHRA Approved.
Me-too-status VildoMET 50mg/1000mg Tablet Reg. No. 073612
M/s High-Q Pharmaceuticals Karachi.
Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AMROFEC SR 100mg Tablet
Strength
Diclofenac Sodium……..100mg
PRODUCTS, NON-STEROIDS.
ATC Code: M01AB05
Type of form Form-5
Pack size and Demand Price 2x10’s. AS per SRO.
Approval status of product in DICLOFENAC SODIUM, 100MG, TABLET,
Reference Regulatory Authorities EXTENDED RELEASE; ORAL
USFDA Approved.
Me-too-status Hirun SR 100mg Tablet Reg. No. 094963
M/s Hilton Pharma (Pvt) Ltd Karachi.
Form 5
ii. The product name is of sustained release product,
formulation and label claim is of enteric coated
tablet. The reference in RRA is of Extended
Release tablet not of enteric coated. Justifications
or corrections are required in label claim and
formulation along with submission of requisite
fee(Full Fee).
Brand Name + Dosage Form and P-N Tablet 5mg
Strength
Norethisterone…………..5mg
Pharmacological Group Progestogens, Estrane derivatives.
ATC Code: G03DC02
Type of form Form-5
Approval status of product in Norethisterone 5mg Tablets PL 29831/0152
Me-too-status Noregyn 5mg Tablet Reg. No. 053336
M/s Zafa Pharmaceutical Lab Karachi.
Remark of the Evaluator. Finished product specifications are not mentioned.
Decision: Deferred for confirmation of manufacturing facility.
Brand Name + Dosage Form and VASTCOR 20mg Tablet
Strength
Simvastatin…………….. 20mg
ATC Code: C10AA01
Approval status of product in Simvastatin 10 mg, 20 mg, 40 mg and 80 mg film-coated
Reference Regulatory Authorities tablets PL 49565/0014-0017
MHRA Approved.
Me-too-status Simvoget Tabl;et 20mg Reg. No. 044047
Remark of the Evaluator. The application is submitted on Form-5A. Application
shall be submitted on correct form i.e. Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and AMBROBION Tablet
Strength
Thiamine Disulphide (Vitamin B1) ……. 100mg
Pyridoxine Hydrochloride (Vitamin B6)…200mg
Cyanocobalamine (Vitamin B12)………..200mcg
Pharmacological Group Vitamin B1 in combination with vitamin B6 and/or vitamin
B12.
ATC Code: A11DB
Me-too-status Neurobion Tablet Reg. No. 001486
M/s Martin Dow Ltd. Karachi.
Finished Product Specifications are not mentioned.
Approval in RRA could not be verified.
 Submission of Specifications.
meeting.
Brand Name + Dosage Form and ZINEDAL 10mg Tablet
Strength
Cetirizine dihydrochloride……………5mg
Pharmacological Group ANTIHISTAMINES FOR SYSTEMIC USE, Piperazine
derivatives
ATC Code: R06AE07
Approval status of product in Cetirizine dihydrochloride 10 mg film-coated tablets
Reference Regulatory Authorities (cetirizine dihydrochloride) - PL 20416/0278
MHRA Approved.
Me-too-status Rigix 10mg Tablet Reg. No. 011248
M/s AGP Ltd. Karachi.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and CANDEN PLUS Tablet 16mg/12.5mg
Strength
Candesartan Cilexetil …….16mg
Hydrochlorothiazide …..12.5mg
ATC code: C09DA06
Approval status of product in Candesartan and Hydrochlorothiazide 8/12.5, 16/12.5,
Reference Regulatory Authorities 32/25 & 32/12.5 mg Tablets - PL 20416/0343-46.
MHRA Approved.
Me-too-status Prosartan-DU 16/12.5 tablets Reg. No. 055826
M/s Helix Pharma Karachi.
The product applied is a film coated product. Product
approved in RRA is an uncoated tablet. Clarification or
correction is required along with submission of
requisite fee.
Product monograph is available in USP and
innovator’s specifications are applied. Justification or
correction is required.
Brand Name + Dosage Form and COXIB 200mg Capsule
Strength
Celecoxib ………….200mg
PRODUCTS, NON-STEROIDS, Coxibs.
ATC Code: M01AH01
Approval status of product in Celecoxib 100 mg capsules, hard and Celecoxib 200 mg
Reference Regulatory Authorities capsules, hard (celecoxib) - PL 35507/0133 -0134
MHRA Approved.
Me-too-status Colixib Capsule 200mg Reg. No. 100505
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and XAMIC 250mg Capsules
Strength
Tranexamic Acid ………..250mg
Pharmacological Group ANTIFIBRINOLYTICS, Amino acids
ATC Code: B02AA02
Pack size and Demand Price 2x10’s. As per SRO
Approval status of product in Could not be confirmed for capsule dosage form.
Me-too-status Haemic Capsule 250mg Reg. No. 039014
M/s Genix Pharma Karachi.
Provide evidence of RRA approval of product in
Capsule dosage form.
meeting.
Brand Name + Dosage Form and XAMIC 500mg Capsules
Strength
Tranexamic Acid ………..500mg
ATC Code: B02AA02
Approval status of product in Could not be confirmed for capsule dosage form.
Me-too-status Haemic Capsule 500mg Reg. No. 039016
M/s Genix Pharma Karachi.
Evidence of RRA approval of product in Capsule
dosage form is required.
meeting.
Brand Name + Dosage Form and MEPRA 20mg Capsule
Strength
Esomeprazole Magnesium trihydrate eq. Esomeprazole
22.5% pellets …20mg
Dairy No. date of R &I fee Dy. No. 15282 dated 07.03.2019.
Fee paid Rs. 80,000/- vide voucher No. 0836445 dated
05.03.2019, endorsed on 07.03.2019
02.03.2019, endorsed on 07.03.2019
Pharmacological Group Proton Pump inhibitors.
ATC Code: A02BC05
Approval status of product in Esomeprazole 20mg Gastro-resistant Capsules
Reference Regulatory Authorities (esomeprazole magnesium dihydrate) - PL 16028/0166.
MHRA Approved.
Me-too-status Nexum 20mg Capsule Reg. No. 033890
M/s Getz Pharma (Pvt.) Ltd. Karachi.
Remark of the Evaluator. i. Source of pellets is required.
ii. The application is submitted on Form-5A.
Application shall be submitted on correct form
i.e. Form 5
 Submission of source of pellets.
Brand Name + Dosage Form and MEPRA 40mg Capsule
Strength
Esomeprazole Magnesium trihydrate eq. Esomeprazole
22.5% pellets …40mg
Dairy No. date of R &I fee Dy. No. 15239 dated 07.03.2019.
05.03.2019, endorsed on 07.03.2019
02.03.2019, endorsed on 07.03.2019
Pharmacological Group Proton Pump inhibitors.
ATC Code: A02BC05
Approval status of product in ESOMEPRAZOLE 40 MG GASTRO-RESISTANT
Reference Regulatory Authorities CAPSULES HARD.
MHRA Approved.
Me-too-status Nexum 40mg Capsule Reg. No. 033891
M/s Getz Pharma (Pvt.) Ltd. Karachi.
Remark of the Evaluator. i. Source of pellets is required.
ii. The application is submitted on Form-5A.
i.e. Form 5
 Submission of source of pellets.
Cream/Ointment Section (General)
Brand Name + Dosage Form and NITRA 20mg/g Oral Gel
Strength
Composition Not provided
Pharmacological Group Antiinfectives and antiseptics for local oral treatment.
ATC Code: A01AB09
Finished product specifications BP Specifications
Pack size and Demand Price 10g, 20g. As per SRO.
Approval status of product in DAKTARIN ORAL GEL miconazole 20mg/g gel tube.
Reference Regulatory Authorities TGA Australia Approved.
Me-too-status DAKTARIN Oral gel 20mg Reg. No. 009078
M/s Aspin Pharma(Pvt) Ltd. Karachi.
i.e. Form 5
ii. Label claim of Next Tablet is given instead of
applied product (page 98). Label Claim of
applied product is required. Also submit fee
for revision of label along with fee (Full Fee)
iii. The gel formulation approved in RRA is an
oral gel, the applied product’s intended clinical
use is not as an oral gel. The Me-too Gel
formulations are also oral gels. Evidence of gel
for non-oral use approved in RRA is required
and also its me-too.
 Submission of formulation and proper label.
 Submission of proper label claim and intended use of product.
 Evidence of approval of applied formulation in reference regulatory authorities/
agencies which were adopted by the Registration Board in its 275th meeting.
Cream/ointment Section (General)
Brand Name + Dosage Form and AMCIN-V 2% Vaginal Cream
Strength
Composition
Pharmacological Group GYNECOLOGICAL ANTIINFECTIVES AND
ANTISEPTICS, ANTIINFECTIVES AND ANTISEPTICS,
EXCL. COMBINATIONS WITH CORTICOSTEROIDS,
Antibiotics.
ATC Code: G01AA10
Pack size and Demand Price 10g, 20g, As per SRO.
Approval status of product in Dalacin Cream 2% (Vaginal Cream)
Reference Regulatory Authorities MHRA approved.
Me-too-status Femcin-V 2% Cream Reg. No. 101644
M/s Evolution Pharma Rawat.
Label claim of GABA Tablet is given instead of
applied product (page 103). Label claim of applied
product is required. Also submit fee for revision of
label claim (Full Fee)
 Submission of formulation and proper label.
 Submission of proper label claim and intended use of product.
 Evidence of approval of applied formulation in reference regulatory authorities/
Cream/ointment Section (General)
Brand Name + Dosage Form and BETASOL OINTMENT 0.05%
Strength
Composition Each gram of Ointment contains;
Clobetasol Propionate………………0.05mg (0.05%
W/W)
Pharmacological Group Corticosteroids, very potent (group IV).
ATC Code: D07AD01
Approval status of product in Clobetasol Propionate 0.05% w/w Ointment
Reference Regulatory Authorities (PL17507/00236)
MHRA Approved.
Me-too-status Clobetol ointment 0.05% Reg. No. 065177
M/s Valor Pharmaceuticals Islamabad
i.e. Form 5
ii. The label claim needs to be corrected as
percentage strength is different from per gram
strength. Also submit requisite fee for revision
of label claim (Full fee)
 Submission of revised label and formulation as per innovator product.
Brand Name + Dosage Form and BETASOL CREAM 0.05%
Strength
Composition Each gram of Cream Contains;
Clobetasol propionate……………..0.05mg(0.05% W/W)
Pharmacological Group Corticosteroids, very potent (group IV).
ATC Code: D07AD01
Approval status of product in Clobetasol Propionate 0.05% w/w Cream (PL 17507/0235)
Me-too-status Clobicare Cream 0.05% Reg. No. 067938
M/s Seatle Pharma Lahore.
i.e. Form 5
ii. The label claim needs to be corrected as
percentage strength is different from per gram
strength. Also submit requisite fee for revision
of label claim (Full fee)
 Submission of revised label and formulation as per innovator product.
Brand Name + Dosage Form and MEBIN 100mg/5ml Oral Suspension
Strength
Composition Each 5ml Suspension Contains;
Mebendazole …………………..100mg
Pharmacological Group ANTINEMATODAL AGENTS, Benzimidazole derivatives.
ATC Code: P02CA01
Approval status of product in VERMOX 100 MG/5 ML ORAL SUSPENSION
Me-too-status Nemazole Suspension Reg. No. 013321
M/s GSK Karachi.
i.e. Form 5
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form and NILSIT Oral DROPS 100,000IU/ml
Strength
Composition Each ml Contains;
Nystatin ………….100,000IU
Pharmacological Group INTESTINAL ANTIINFECTIVES, Antibiotics.
ATC Code: A07AA02
Type of form Form-5
Pack size and Demand Price 30ml, As per SRO.
Approval status of product in NYSTATIN ORAL SUSPENSION BP
Me-too-status Nilstat Drops Reg. No. 001554
M/s ICI Pakistan Hattar.
Remark of the Evaluator. i. It is not mentioned what will be the
specifications of Finished Product.
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Injection Section (General)
Brand Name + Dosage Form and ANZAL 600mg/300ml Infusion
Strength
Linezolid………….200mg
ATC Code: J01XX08
Approval status of product in Linezolid 2 mg/ml Solution for Infusion - PL 36780/0001;
Reference Regulatory Authorities UK/H/5511/001/DC
Each infusion bag contains 300 ml of Linezolid 2mg/ml
Infusion.
MHRA Approved.
Me-too-status Nezkil 600mg Infusion Reg. No. 048804
M/s SJ&Fazul Ellahi Karachi.
i.e. Form 5
ii. Section approval letter is required along with
evidence that LVP manufacturing facility is
present.
iii. Label claim given at page 121 mentions that
each 100ml contains 600mg/300ml. The label
claim needs to be corrected along with
submission of requisite fee (Full fee)
 Submission of proper label claim and formulation.
meeting.
 Evidence of LVP Section/manufacturing facaility.
Brand Name + Dosage Form and ANZAL 200mg/100ml Infusion
Strength
Linezolid………….200mg
ATC Code: J01XX08
Approval status of product in LINEZOLID, 200MG/100ML (2MG/ML), SOLUTION;
Reference Regulatory Authorities INTRAVENOUS.
USFDA Approved.
Me-too-status Nezkil 200mg Infusion Reg. No. 048802
M/s SJ&Fazul Ellahi Karachi.
i.e. Form 5
ii. Section approval letter is required along with
evidence that LVP manufacturing facility is
present.
 Evidence of LVP Section/manufacturing facaility.
Brand Name + Dosage Form and VENTO 0.5mg/1ml Injection
Strength
Composition Each 1ml Ampoule Contains;
Albuterol Sulfate …..0.5mg
ATC Code: R03CC02
Approval status of product in Ventolin 500mcg/ml Injection (1ml glass ampoule)
Me-too-status Ventolin Injection Reg. No. 005904
M/s GSK Karachi.
i.e. Form 5
ii. It is not mentioned that whether product will
be an ampoule or a vial. And also volume of
injection is not mentioned.
iii. The route of administration is mentioned as
oral.

 Submission of details of product including formulation, label claim and intended use.
Brand Name + Dosage Form and ZEEN 10mg/ml Injection IV/IM
Strength
Nalbuphine HCl…………….10mg
Pharmacological Group OPIOIDS, Morphinan derivatives.
ATC Code: N02AF02
Approval status of product in Could not be verified as container and volume is not
Reference Regulatory Authorities mentioned.
Me-too-status Bunail Injection 10mg/ml Reg. No. 053437
M/s Bosch Pharmaceuticals Karachi.
i.e. Form 5
ii. Dosage Form is mentioned as film coated
tablet.
iii. Route of Administration is mentioned as oral
iv. Evidence of approval of product in RRA could
not be verified. Proper Evidence of approval of
product having similar volume and container
in RRA is required.
meeting.
 Submission of proper details of the applied product including label claim, formulation
and intended use.
Brand Name + Dosage Form and ZEEN 20mg/ml Injection IV/IM
Strength
Nalbuphine HCl…………….20mg
Pharmacological Group OPIOIDS, Morphinan derivatives.
ATC Code: N02AF02
Approval status of product in Could not be verified as container and volume is not
Reference Regulatory Authorities mentioned.
Me-too-status Bunail Injection 20mg/ml Reg. No. 053438
i.e. Form 5
ii. Dosage Form is mentioned as film coated
tablet.
iii. Route of Administration is mentioned as oral
iv. Evidence of approval of product in RRA could
not be verified. Proper Evidence of approval of
product having similar volume and container
in RRA is required.
meeting.
and intended use.
Brand Name + Dosage Form and AMCIN-C Injection 150mg/ml
Strength
Clindamycin as Phosphate …..150mg
STREPTOGRAMINS, Lincosamides.
ATC Code: J01FF01
Approval status of product in CLINDAMYCIN 150MG/ML SOLUTION FOR
Reference Regulatory Authorities INJECTION PL 24780/0002 2ml and 4ml ampoules
MHRA Approved.
Me-too-status Dalacin C Injection Reg. No. 004592
M/s Pfizer Pakistan Karachi.
i.e. Form 5
ii. It is not mentioned whether product will be an
ampoule or vial, neither volume is mentioned.
The strength, volume and container should be
as that of innovator, for revision submit
requisite fee (Full Fee.)
and intended use.
Brand Name + Dosage Form and AMCIN-C Injection 300mg/ml
Strength
Clindamycin as Phosphate …..300mg
STREPTOGRAMINS, Lincosamides.
ATC Code: J01FF01

i.e. Form 5
ii. It is not mentioned whether product will be an
ampoule or vial, neither volume is mentioned.
iii. Evidence of product approval in RRA is
required.
iv. Evidence of me-too is required.
meeting.
 Submission of details of applied product i.e. formulation, label, container closure
system etc.
Brand Name + Dosage Form and DECADON INJECTION 8mg/2ml (IV/IM)
Strength
Composition Each 2ml Vial Contains;
Dexamethasone Sodium Phosphate Eq. to Dexamethasone
Phosphate ………8mg
Pharmacological Group Glucocorticoids
ATC Code: H02AB02
Type of form Form-5
Pack size and Demand Price 2ml Vial. As per SRO.
Approval status of product in DEXAMETHASONE 8.3 MG/ML SOLUTION FOR
Reference Regulatory Authorities INJECTION - PL 01502/0081
MHRA Approved.

Remark of the Evaluator. i. Specifications of Finished product are not
mentioned.
ii. Provide Me-too of the applied product.
iii. Provide evidence of RRA approval of the
applied product.
 Submission of specifications of the finished product.
meeting.
 Evidence of approval of required manufacturing facility of “Liquid Injecatble
(Steroid)” Section from CLB.
Brand Name + Dosage Form and XAMIX 250mg/5ml Injection
Strength
Composition Each 5ml Injection Contains;
Tranexamic Acid……..250mg
ATC Code: B02AA02
Approval status of product in Could not be verified for strength of 250mg
Me-too-status Transamin Injection 250mg Reg. No. 007534

i.e. Form 5
ii. Route of administration is mentioned as Oral.
iii. It is not mentioned whether injection will be a
vial or an ampoule. Volume of injection is also
not mentioned in the label claim. Mention
volume of injection along with submission of
requisite fee (Full Fee)
iv. Evidence of approval of the product in RRA
having applied strength is required.
 Submission of intended route of administration of applied product.
 Submission of details of applied product i.e. label, formulation, container closure
system etc.
Brand Name + Dosage Form and AMROKET 30mg/3ml Injection (IM/IV) (For toll
Strength manufacturing)
Ketorolac Tromethamine………..30mg
ATC Code: M01AB15
Pack size and Demand Price 1x1 As per SRO.
Me-too-status Toralac Injection 30mg Reg. No. 050290
M/s Global Pharma Islamabad.
Remark of the Evaluator. i.The application is submitted on Form-5A.
i.e. Form 5
ii. Contract manufacturing details are not
provided and on application form Toll
manufacturing is mentioned.
iii. Volume of ampoule is not mentioned. It needs
to be defined along with submission of
requisite fee (Full Fee).
 Submission of details of applied product i.e. formulation, label, container closure
system etc.
 Submission of clarification why contract manufacturing is mentioned in the
application.
Ear/Eye Drop Section (General)
Brand Name + Dosage Form and GENTAMYCIN HC DROPS 0.3%/1%
Strength
Gentamycin Sulphate eq. to Base………… 0.3%W/V
Hydrocortisone Acetate……………..1.0% W/V
Pharmacological Group Corticosteroids and antiinfectives in combination.
ATC Code: S03CA04
Pack size and Demand Price 5ml. as per SRO
Approval status of product in GENTAMICIN 0.3% W/V AND HYDROCORTISONE
Reference Regulatory Authorities ACETATE 1% W/V EAR DROPS, GENTISONE HC
EAR DROPS
MHRA Approved.
Me-too-status Otogen HC Ear Drops Reg. No. 016662
M/s Remington Pharmaceuticals Lahore.
Remark of the Evaluator. i. Specifications of finished product are not
defined.
ii. Pack size if of 5 ml and label claim is made of
100ml, justification or correction is required
iii. The pack size of RRA approved product is
10ml, justification for applied pack size is
required.
meeting.
 Submission of specifications of the applied product.
330. Name and address of manufacture / M/s ARP (Pvt) Ltd., Plot No. 12 & 12 A, Street No. W-
Applicant 3, National Industrial Zone Rawat. (DML No. 000682)
Brand Name + Dosage Form and VERTOCIN Tablet 16mg
Strength
Composition Each tablet contains:
Betahistine Dihydrochloride ……………. 16mg
Dairy No. date of R &I fee Dy. No. 14829 dated 07-03-2019 Rs.20,000/- dated 06-
03-2019 Challan No. 0760161.
Pharmacological Group ANTIVERTIGO PREPARATIONS
ATC Code: N07CA01
Type of form Form 5
Finished product specifications BP specifications
Pack size and Demand Price 30’s, as per SRO
Approval status of product in Betahistine Dihydrochloride 16mg Tablets,
Me-too-status BHS Tablet 16mg, Rotex Pharma, Reg. No. 100819
GMP Status Last inspection conducted on 28.12.2021. The GMP

status is reported as compliant.
Decision: Approved
331. Name and address of manufacture / M/s ARP (Pvt) Ltd., Plot No. 12 & 12 A, Street No. W-3,
Applicant National Industrial Zone Rawat. (DML No. 000682)
Brand Name + Dosage Form and VERTOCIN Tablet 8 mg
Strength
Betahistine Dihydrochloride …………….. 8 mg
Dairy No. date of R &I fee Dy. No. 14828 dated 07-03-2019 Rs.20,000/- dated 06-03-
2019 Challan No. 0760160.
Pharmacological Group N07C ANTIVERTIGO PREPARATIONS
Type of form Form 5
Finished product specifications BP specifications
Approval status of product in Betahistine Dihydrochloride 8mg Tablets, MHRA
Reference Regulatory Authorities Approved
Me-too-status BHS Tablet 8mg, Rotex Pharma, Reg. No. 100819
GMP Status Last inspection conducted on 28.12.2021. The GMP status

is reported as compliant.
Decision: Approved
Brand Name + Dosage Form and NEOGLIP 2.5mg Tablet
Strength
Saxagliptin HCl (Anhydrous) Eq. to Saxagliptin ……..2.5
mg
Dairy No. date of R &I fee Dy. No. 14842 dated 07-03-2019, Rs. 20,000/- dated
06.03.2019. Challan No. 0760174
Pharmacological Group Drugs used in diabetes. Dipeptidyl peptidase 4 (DPP4)
inhibitors, ATC code: A10BH03
Type of form Form 5
Finished product specifications ARP Specs
Approval status of product in Onglyza 2.5 mg film-coated tablets
Reference Regulatory Authorities Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
MHRA Approved
Me-too-status Saglip 2.5mg Tablet Reg. No. 071487.
Mfg by M/s CCL Lahore.
Remark of the Evaluator. i. The Pharmacological group of the drug
mentioned in the application is Psychotropic
agent. The ATC for drug Saxagliptin is
A10B defined as BLOOD GLUCOSE
LOWERING DRUGS, EXCL. INSULINS.
Also submit requisite fee.
ii. The manufacturing method provided mentions
that the tablet will be manufactured by simple
compression having active in the compressed
core, then it will be film coated. The
manufacturing method of the innovator is
through active coating process. The revised
manufacturing method is required to be
submitted along with supplementary data. Also
submit requisite fee.
The firm has submitted the revised Form-5 and revised
manufacturing method as per innovator product, along with
fee of Rs. 7500/- paid vide slip No. 54293912720 dated
23.09.2022.
 Submission of detailed manufacturing method as per innovator product along with
evidence of required equipment for manufacturing it.
 Submission of evidence that manufacturing process will prevent cyclization of the
API.
 Submission of stability study data as per guidelines provided in 293rd meeting of
Registration Board.
Brand Name + Dosage Form and VORIFEN 200mg Tablet
Strength
Composition Each Film coated tablet contains;
Voriconazole…………… 200 mg
Dairy No. date of R &I fee Dy. No. 14831, dated 07.03.2019.
Fee Paid: Rs. 20,000/- dated 06.03.2019 vide slip No.
0760163
Pharmacological Group Antimycotics for systemic use, triazole derivatives ATC
code J02AC03
Type of form Form 5
Finished product specifications JP Specifications.
Approval status of product in VFEND Voriconazole 200 mg Oral Tablet
Me-too-status Vorif Tablet 200mg Reg. No. 069765.
Mfg by M/s Ferozsons Laboratories Ltd., Amangarh
Nowshehra, Nowshera.
Decision: Approved.
Brand Name + Dosage Form and ISOVEN ER Tablet 50mg
Strength
Composition Each Extended Release Tablet Contains;
Desvenlafaxine (as succinate)……… 50 mg
0760182
Pharmacological Group Other Antidepressants. ATC Code: N06AX23
Type of form Form 5
Finished product specifications ARP Specifications
Approval status of product in Pristiq (desvenlafaxine) Extended-Release tablets, oral
Me-too-status Dessyn XR 50mg Tablet, Reg. No. 091609.
M/s Medisynth Pharmaceuticals Rawat.
Decision: Approved with innovator’s Specifications. Registration letter shall be issued after
submission of fee Rs. 7500/- for revision of specifications.
Brand Name + Dosage Form and ISOVEN ER Tablet 100mg
Strength
Desvenlafaxine (as succinate)……… 100 mg
0760183
Pharmacological Group Other Antidepressants. ATC Code: N06AX23
Type of form Form 5
Approval status of product in Pristiq (desvenlafaxine) Extended-Release tablets, oral
Me-too-status Dessyn XR 100mg Tablet, Reg. No. 091610.
M/s Medisynth Pharmaceuticals Rawat.
status is reported as compliant.
Brand Name + Dosage Form and MUSOREL MR 200 mg Capsule.
Strength
Composition Each MR capsule contains (Modified Release);
Mebeverine HCl SR 50% Pellets Eq. to Mebeverine HCl
……. 200mg
(source of Pellets: M/s Vision Pharmaceuticals

Islamabad DML No. 000806)
0760184
group.
ATC Code: A03AA04
Type of form Form 5
Approval status of product in COLOFAC MR Modified Release Capsule
Reference Regulatory Authorities Mebeverine hydrochloride 200 mg
Manufactured by Mylan Products Ltd. 20 Station Close
Potters Bar Herts EN6 1TL United Kingdom.
MHRA Approved.
Me-too-status Mebever MR 200mg Capsule Reg. No. 050747
Brand Name + Dosage Form and Q-REX Tablet 100 mg
Strength
Quetiapine (as Fumarate) ………. 100 mg
0760176
Pharmacological Group Antipsychotics; Diazepines, oxazepines and thiazepines
ATC code: N05AH04
Type of form Form 5
Pack size and Demand Price 10’s, 20’s, 30’s. As per SRO.
Approval status of product in Quetiapine film coated tablet (25mg, 100mg, 150mg,
Reference Regulatory Authorities 200mg) by M/s Aurobindo pharma,
MHRA Approved.
Me-too-status Quepin 100mg Tablet Reg. No. 055644
M/s Platinum Pharmaceuticals (Pvt.) Ltd., Karachi
status is reported as compliant..
Decision: Approved.
Brand Name + Dosage Form and Q-REX XR Tablet 300 mg
Strength
Quetiapine (as Fumarate) ……… 300 mg
0760186
ATC code: N05AH04
Type of form Form 5
Approval status of product in SEROQUEL XR (quetiapine fumarate) Extended-Release
Reference Regulatory Authorities Tablets 200 mg, 300 mg, and 400 mg
M/s AstraZeneca Pharmaceuticals LP 36 Wilmington, DE
19850 USA
FDA Approved.
Me-too-status Pequit XR 300mg Tablets Reg. No. 075488
Each XR coated Tablet contains;
Quetiapine (as fumarate): 300mg
M/s Medizan Laboratories (Pvt) Ltd., Plot No 313
Industrial Triangle Kahuta Road Islamabad., Islamabad
Decision: Approved.
Brand Name + Dosage Form and Q-REX XR Tablet 150 mg
Strength
Composition Each Extended Release Tablet contains;
Quetiapine (as fumarate) ……. 150 mg
0760185
ATC code: N05AH04
Type of form Form 5
Approval status of product in Seroquel XL 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
Reference Regulatory Authorities prolonged-release tablets
AstraZeneca UK Ltd, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, United Kingdom
MHRA Approved.
Me-too-status Pequit XR 150mg Tablets Reg. No. 075486
Each XR coated Tablet contains;
Quetiapine (as fumarate): 150 mg
M/s Medizan Laboratories (Pvt) Ltd., Plot No 313
Industrial Triangle Kahuta Road Islamabad., Islamabad.
Decision: Approved.
Brand Name + Dosage Form and Q-REX Tablet 25 mg
Strength
Quetiapine (as fumarate) ……. 25 mg
0760175
ATC code: N05AH04
Type of form Form 5
Pack size and Demand Price 10’s 20’s 30’s. As per SRO
Approval status of product in Seroquel 25 mg, 100 mg, 200 mg and 300 mg film-coated
Reference Regulatory Authorities tablets
MHRA Approved.
Me-too-status Quepin 25mg Tablet Reg. No. 055643
M/s PlatinumPharmaceuticals(Pvt.) Ltd., Karachi
Decision: Approved.
Brand Name + Dosage Form and MESOBAC Tablet 10 mg
Strength
Baclofen ……. 10 mg
0760168
Pharmacological Group Muscle relaxants, centrally acting agents, Other centrally
acting agents
ATC Code: M03BX01
Type of form Form 5
Approval status of product in Baclofen 10 mg Tablets
Reference Regulatory Authorities M/s TEVA UK Limited, Eastbourne, BN22 9AG, UK
MHRA Approved.
Me-too-status Baclin Tablet Reg. No. 063100
Baclofen………..10mg
M/s Genome Pharmaceuticals (Pvt) Ltd., Plot No.16/1
Phase No. IV Industrial Estate Hattar Distt Haripur.,
Haripur
Decision: Approved.
Brand Name + Dosage Form and PROQUAD Tablet 150mg/75mg/400mg/275mg
Strength
Composition Each Film Coated Tablet Tablet Contains;
Rifampicin …………………... 150 mg
Isoniazide ……………………. 75 mg
Pyrazinamide ……………….... 400 mg
Ethambutol Hydrochloride ….. 275 mg
0760165
Pharmacological Group Combinations of drugs for treatment of tuberculosis
(rifampicin, pyrazinamide, ethambutol and isoniazid).
ATC Code: J04AM06
Type of form Form-5
Approval status of product in Rimstar 150 mg/75 mg/400 mg/275 mg Film-coated
M/s Sandoz Limited Park View, Riverside Way
Watchmoor Park Camberley, Surrey GU15 3YL United
Kingdom
MHRA Approved.
Me-too-status Myrin P Forte Tablets Reg. No. 027082
Decision: Approved.
Brand Name + Dosage Form and FUNOKET 200 mg Tablet
Strength
Ketoconazole ………..200mg
0760169
Pharmacological Group CORTICOSTEROIDS FOR SYSTEMIC USE,
Anticorticosteroids
ATC Code: H02CA03
Type of form Form-5
Approval status of product in Ketoconazole HRA 200 mg tablets
Me-too-status KZ 200mg Tablet Reg. No. 092348
M/s Seraph Pharmaceutical, Plot No.210, Industrial
Triangle, Kahuta Road, Islamabad
Remark of the Evaluator. The Pharmacological group mentioned in application is
“broad-spectrum synthetic antifungal agent”. The
pharmacotherapeutic group of the reference product (i.e.
Ketoconazole HRA 200mg tablet) is Corticosteroids for
systemic use, Anticorticosteroids ATC Code: H02CA03.
Evidence of pharmacological group along with supporting
data is required or Pharmacological group may be revised
The firm has provided the requisite information along
with submission of fee Rs. 7500/- vide Slip No.
1861017220 dated 23.09.2022.
Decision: Approved.
Brand Name + Dosage Form and ZEEMIG Tablet 5 mg
Strength
Zolmitriptan ……………. 5 mg
0760181
Pharmacological Group ANTIMIGRAINE PREPARATIONS, Selective serotonin
(5HT1) agonists
ATC Code: N02CC03
Type of form Form-5
Approval status of product in Zolmitriptan 5mg Film-coated Tablets
Reference Regulatory Authorities M/s Accord, Barnstaple, EX32 8NS, UK
MHRA Approved
Me-too-status Zolon Tablet Reg. No. 088749
M/s Shrooq Pharmaceuticals (Pvt) Ltd , 21-Km Ferozepur
Road, Lahore
Decision: Approved.
Brand Name + Dosage Form and BUSPORIL Tablet 5 mg
Strength
Buspirone Hydrochloride …….. 5 mg
0760164
Pharmacological Group Anxiolytics, Azaspirodecanedione Derivatives.
ATC Code: N05BE01
Type of form Form-5
Approval status of product in Buspar Tablets 5 mg
Reference Regulatory Authorities M/s Accord Healthcare Limited Sage House 319 Pinner
Road North Harrow Middlesex HA1 4HF United
Kingdom.
MHRA Approved
Me-too-status Buspro Tablet 5mg Reg. No. 094261
M/s Medisynth Pharmaceuticals, Plot No. 55 Street No. S-
5 National Industrial Zone Rawat.
Decision: Approved.
Brand Name + Dosage Form and RENAID Tablet
Strength
α-keto analogue to isoleucine calcium salt …. 67 mg
α-keto analogue to leucine calcium salt …. …101 mg
α-keto analogue to phenylalanine calcium salt . 68 mg
α-keto analogue to valine calcium salt …. 86 mg
α-hydroxy analogue to methionine calcium salt 59 mg
Lysine acetate …………………. 105 mg
L-threonine ………………….. 53 mg
L-tryptophan ………………… 23 mg
L- histidine ………………….. 38 mg
L- tyrosine ……………… 30 mg
Total Nitrogen content per tablet ……….. 36 mg
Calcium content per tablet …1.25 mmol = 50 mg
0760162
Pharmacological Group GENERAL NUTRIENTS, OTHER NUTRIENTS Amino
acids, incl. combinations with polypeptides
ATC Code: V06DD
Type of form Form-5
Finished product specifications ARP Specifications.
Approval status of product in KETOSTERIL by Fresenius Kabi, Germany.
Reference Regulatory Authorities (Bfarm approved)
Me-too-status Ketoalfa Tablets Reg. No. 076807
M/s Genome Pharmaceuticals (Pvt) Ltd., Plot No.16/1
Phase No. IV Industrial Estate Hattar Distt Haripur
Decision: Deferred for evidence of availability of testing facility for drug product along with
analytical procedure.
Brand Name + Dosage Form and FERIX 150 mg Capsule.
Strength
Iron polysaccharide Complex equivalent to Elemental
Iron ………………… 150 mg
0760171
Pharmacological Group Antianemic preparations, Iron trivalent, oral preparations
ATC Code: B03AB02
Type of form Form-5
Approval status of product in NA
Me-too-status Ferricure Capsule Reg. No. 050637
M/s SJ & G Fazul Ellahie, , Karachi
Decision: Registration Board approved the case with innovator’s specification, since iron
preparations are not considered as drug by various reference regulatory authorities. Registration
letter shall be issued after submission of fee Rs. 7500/- for revision of specifications.
Semi Solids Cream/ointment/Gel Section (General)
Brand Name + Dosage Form and FUNOKET CREAM 2%
Strength
Composition Each gram of Cream contains;
Ketoconazole ………….. 2% W/W (20 mg)
0760170
Pharmacological Group Imidazole and triazole derivatives
ATC Code: D01AC08
Type of form Form-5
Pack size and Demand Price 1 x 5g, 10g, 15g. As per SRO
Approval status of product in Daktarin Gold 2% Cream
Reference Regulatory Authorities M/s McNeil Products Limited
MHRA Approved
Me-too-status Ramaket Cream 2% w/w Reg. No. 096908
M/s Caliph Pharmaceuticals (Pvt) Ltd., Plot No. 17
Industrial Estate Risalpur
Decision: Approved.
Sachet Section (General)
Brand Name + Dosage Form and MUCAID 200 mg Powder for Oral Solution
Strength
Composition Each Sachet Contains;
Acetylcysteine powder for oral solution …… 200 mg
0760173
Pharmacological Group Expectorants, Excl. Combinations With Cough
Suppressants, Mucolytics.
ATC Code: R05CB01
Type of form Form-5
Approval status of product in Acetylcysteine 200 mg Powder for Oral Solution (Sachet)
Reference Regulatory Authorities M/s Sovereign Medical UK
MHRA Approved.
Me-too-status Acekan 200mg Sachets Reg. No. 077289
M/s Jaskan Pharmaceuticals (Pvt) Ltd. , Plot No. 50
Sunder Industrial Estate Lahore
Semi Solids Cream/ointment/Gel Section (General)
Brand Name + Dosage Form and BIFOTEN 1% Cream
Strength
Composition Each gram of Cream Contains;
Bifonazole …………… 1%(W/W) (10mg)
0760180
Pharmacological Group Antifungal for Topical Use
ATC Code: D01AC10
Type of form Form-5
Pack size and Demand Price 15g tube. As per SRO
Approval status of product in Canesten Bifonazole Cream
Reference Regulatory Authorities The cream contains 1% w/w bifonazole
M/s Bayer plc Consumer Care Division England
MHRA Approved.
Me-too-status Canesten Extra Cream Reg. No. 007484
M/s Bayer Pakistan (Pvt) Ltd., C-21, S.I.T.E, Karachi
351. Name and address of manufacture / M/s Arsons Pharmaceutical (Pvt.) Ltd. 2.5 Km Defence
Applicant Road, off Multan Road Lahore Pakistan. (DML No.
000514)
Capsule Section (General Antibiotic)
Brand Name + Dosage Form and DEXAZOL Capsule 60 mg
Strength
Composition Each Dual Delayed Release Capsule Contains;
Dexlansoprazole………...60 mg
07.03.2019
ATC Code: A02BC06
Type of form Form-5
Pack size and Demand Price 14’s 28’s, as per SRO
Approval status of product in DEXILANT (dexlansoprazole) delayed-release capsules,
Reference Regulatory Authorities for oral use
Delayed-release capsules: 30 mg and 60 mg
MHRA Approved.
Me-too-status Remit DR Capsules 30 mg Reg. No. 090301
M/s Scotmann Pharmaceuticals Plot No. 5-D, Sector I-
10/3 Islamabad.
GMP Status Inspection report provided is dated 29.09.2021.
GMP status is good.
Remark of the Evaluator. 1. Source of pellets: M/s Vision Pharma
Decision: Deferred for stability study data as per guidelines provided in 293rd meeting of
Registration Board.
000514)
Capsule Section (General Antibiotic)
Brand Name + Dosage Form and DEXAZOL Capsule 30 mg
Strength
Composition Each Dual Delayed Release Capsule Contains;
Dexlansoprazole…………....30 mg
07.03.2019
ATC Code: A02BC06
Type of form Form-5
Pack size and Demand Price 14’s 28’s, as per SRO
Approval status of product in DEXILANT (dexlansoprazole) delayed-release capsules,
Reference Regulatory Authorities for oral use
Delayed-release capsules: 30 mg and 60 mg
MHRA Approved.
Me-too-status Daplazole DDR Capsule 30 mg Reg. No. 104251
M/s AGP Ltd. Karachi.
GMP status is good.
Remark of the Evaluator. 1. Source of pellets M/s Vision Pharma
Decision: Deferred for stability study data as per guidelines provided in 293rd meeting of
Registration Board.
000514)
Brand Name + Dosage Form and Levosol Tablets 25 mg
Strength
Levosulpiride ………. 25 mg
07.03.2019
Pharmacological Group ANTIPSYCHOTICS, Benzamides,
ATC Code:N05AL07
Type of form Form-5
Pack size and Demand Price 10’s,14’s, 20’s, 30’s, A+s per SRO
Approval status of product in Levosulpiride Aristo 25 mg tablets, AIFA Italy approved.
Me-too-status Sulvoric 25mg Tablet Reg. No.070484
M/s High-Q
GMP status is good.
Decision: Approved.
000514)
Brand Name + Dosage Form and TERBINA TABLET 125 mg
Strength
Terbinafine HCl equivalent to Terbinafine…. 125 mg
07.03.2019
Pharmacological Group Antifungals for systemic use.
ATC Code: D01BA02
Type of form Form-5
Approval status of product in TERBINAFINE 125MG TABLETS (TERBINAFINE
Reference Regulatory Authorities HYDROCHLORIDE)
MHRA Approved
Me-too-status Brandit Tablet 125 mg Reg. No. 090822
GMP status is good.
Remark of the Evaluator. 1. The Label claim of RRA approved products is
for Terbinafine base 125 mg as HCl Salt, the
applied label claim needs to be revised
accordingly along with submission of requisite
fee(Full fee).
The firm has revised the label claim as per
RRA approved product along with
submission of Fee Rs. 7500/- vide Slip No.
2743183351 dated 04.10.2022
Decision: Approved. Registration letter shall be issued after submission of differential fee of
Rs. 22,500/- by the firm for pre-approval change for equivalency as per as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
000514)
Brand Name + Dosage Form and TERBINA TABLET 250 mg
Strength
Terbinafine HCl equivalent to Terbinafine…. 250 mg
07.03.2019
Pharmacological Group Antifungals for systemic use.
ATC Code: D01BA02
Type of form Form-5
Approval status of product in TERBINAFINE 250MG TABLETS (TERBINAFINE
Reference Regulatory Authorities HYDROCHLORIDE)
MHRA Approved
Me-too-status Brandit Tablet 250 mg Reg. No. 090823
GMP status is good.
Remark of the Evaluator. 1. The Label claim of RRA approved products is
for Terbinafine base 250 mg as HCl Salt, the
applied label claim needs to be revised
fee(Full Fee).
The firm has revised the label claim as per
RRA approved product along with
submission of Fee Rs. 7500/- vide Slip No.
387779024 dated 04.10.2022
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
000514)
Cream/ ointment/ Gel (General)
Brand Name + Dosage Form and ARSIBACT-H CREAM 15gm
Strength
Composition Each gram of cream contains;
Fusidic acid….. 20 mg
Hydrocortisone acetate……… 10 mg
07.03.2019
Pharmacological Group Corticosteroids, weak, combinations with antibiotics
ATC Code: D07CA01
Type of form Form-5
Pack size and Demand Price 15gm. Rs. 250/- per tube.
Approval status of product in FUCIDIN® H
Reference Regulatory Authorities Fusidic acid and Hydrocortisone acetate
2% / 1% Cream
Health Canada Approved.
Me-too-status Fusiwin-H Cream Reg. No. 062471
M/s Hoover Pharmaceuticals Lahore.
GMP status is good.
Decision: Approved.
000514)
Cream/ Ointment/ Gel (General)
Brand Name + Dosage Form and TERBINA 10MG CREAM
Strength
Composition Each gram of cream contains;
Terbinafine HCl…10mg
07.03.2019
Pharmacological Group Other antifungals for topical use.
ATC Code: D01AE15
Type of form Form-5
Pack size and Demand Price 10gm, as per SRO
Approval status of product in LAMISIL 1% w/w Cream
Me-too-status Lamisil Cream 1 %
M/s GSK Petaro Road Jamshoro.
Latest inspection report is required.s
Decision: Approved.
000514)
Cream/Ointment/Gel (General)
Brand Name + Dosage Form and ARSONE OINTMENT 15GM
Strength
Composition Each Tube Contains;
Mometasone Furoate …….1mg/g
07.03.2019
Pharmacological Group CORTICOSTEROIDS, PLAIN, Corticosteroids, potent
(group III)
ATC Code: D07AC13
Type of form Form-5
Approval status of product in Mometasone Furoate 0.1% W/W Oitnment.
Me-too-status Biometa Ointment Reg. No. 08619
M/s Bio-Labs Islamabad
GMP status is good.
Decision: Approved. Firm shall submit evidence of availability of separate dispensing booth for
steroidal formulations, before issuance of registration letter.
000514)
Cream/ Oitnment/ Gel (General)
Brand Name + Dosage Form and CLINDACIN GEL 30GM
Strength
Composition Each Gram Contains;
Clindamycin Phosphate equivalent to Clindamycin 1%
w/w
07.03.2019
Pharmacological Group Antiinfectives for treatment of acne
ATC Code: D10AF01
Type of form Form-5
Pack size and Demand Price 30 gm, Rs. 320/- per Tube
Approval status of product in ZINDACLIN clindamycin (as clindamycin phosphate)
Reference Regulatory Authorities 1% topical gel tube
TGA Australia Approved.
Me-too-status Daymac gel 10mg Reg. No. 062452
GMP status is good.
Decision: Approved.
000514)
Cream/ Ointment/ Gel (General)
Brand Name + Dosage Form and ARSIBACT-B CREAM 15GM
Strength
Composition Each Gram Cream Contains;
Fusidic Acid……. 20mg
Betamethasone as Valerate ….. 1mg
07.03.2019
Pharmacological Group Corticosteroids, potent, combinations with antibiotics,
betamethasone and antibiotics.
ATC Code: D07CC01
Type of form Form-5
Pack size and Demand Price 15gm, Rs. 350/- per tube.
Approval status of product in Fusidic acid/Betamethasone 20 mg/g + 1mg/g cream
Me-too-status Fuswin-B Cream Reg. No. 062470
GMP status is good.
Remark of the Evaluator. 1. Specifications of Finished products are not
provided.
2. The label claim is required to be revised, the
reference RRA approved product mentions 1mg
Betamethasone as valerate. Also submit
requisite fee (Full Fee).
The firm was communicated the observations. The firm
has mentioned that finished product specifications will
be innovator’s specifications and has revised the label
claim from “betamethasone valerate” to “betamethasone
as valerate”. Along with submission of Fee Rs. 7500/-
vide slip No. 2935179779 dated 04.10.2022. The firm has
not submitted full fee.
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
361. Name and address of manufacture / M/s Avensis Pharmaceuticals, (DML No. 000894)
Applicant Plot No. F-24/1, Eastern Industrial Zone, Port Muhammad
Bin Qasim, Karachi.
Tablet (Psychotropic) Section
Brand Name + Dosage Form and Dormilam Tablet 7.5mg
Strength
Midazolam …..7.5 mg (as midazolam maleate)
Dairy No. date of R &I fee Dy. No. 17394 dated 07.03.2019. Fee paid Rs. 20,000/-
vide Deposit Slip No. 0761618 dated 05.03.2019. Endorsed
on 07.03.2019.
Pharmacological Group Benzodiazepine derivatives.
ATC Code: N05CD08
Type of form Form-5
Approval status of product in Dormicum 7.5 mg film-coated tablets
Reference Regulatory Authorities Bfarm Germany Approved.
Me-too-status Dormicum Tablet 7.5mg Reg. No. 011231
M/s Martin Dow Marker Quetta.
GMP Status Last inspection conducted on 31.08.2021.
Status is OK.
Remark of the Evaluator. The reference product is film coated, whereas applied
product is not film coated. Clarification/ correction is
required along with submission of requisite fee.
Decision: Approved as film coated tablet and change of brand name. Registration letter
shall be issued after submission of revised formulation of film coated tablet and Rs. 7500/-
fee for pre-approval change in formulation as per notification No.F.7-11/2012-B&A/DRAP
dated 13-07-2021.
362. Name and address of manufacture / M/s Avensis Pharmaceuticals,(DML No. 000894)
Bin Qasim, Karachi.
Brand Name + Dosage Form and MS Contin Tablet 10 mg
Strength
Morphine Sulphate…….. 10 mg
on 07.03.2019.
Pharmacological Group Analgesics, Natural opium alkaloids
ATC Code: N02AA01
Type of form Form-5
Approval status of product in Could not be confirmed
Me-too-status Qonza 10mg Tablet Reg. No. 071221
M/s Wilshire Laboratories Lahore.
Status is OK.
Remark of the Evaluator. 1. The Pharmacological group is mentioned as
Anti pyretic. It needs to be corrected along with
2. The evidence of approval in RRA is required.
Provided reference was not of registered
product in RRA.
3. Form-5 and undertaking submitted are
unsigned. Signed Undertakings and Form-5 are
required.
Bin Qasim, Karachi.
Brand Name + Dosage Form and Soseget 25mg Tablet
Strength
Composition Each tablet Contains;
Pentazocine HCl…… 25 mg
on 07.03.2019.
Pharmacological Group Opioid analgesics, Benzomorphan derivatives
ATC Code: N02AD01
Type of form Form-5
Approval status of product in PENTAZOCINE TABLETS BP 25mg
Me-too-status Segon Tablet Reg. No. 060093
M/s Aries Pharmaceuticals Peshawar.
Status is OK.
Remark of the Evaluator. The Pharmacological group is mentioned as
psychotropic. It needs to be corrected along with
Decision: Approved and change of brand name. Registration letter shall be issued after
submission of correct pharmacological group along with fee Rs. 7500/- for pre-approval
changes as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Bin Qasim, Karachi.
Brand Name + Dosage Form and Rita 10 mg Tablet
Strength
Methylphanidate HCl……………..10 mg
on 07.03.2019.
Pharmacological Group PSYCHOSTIMULANTS, AGENTS USED FOR ADHD
AND NOOTROPICS, Centrally acting sympathomimetics.
ATC code: N06BA04
Type of form Form-5
Approval status of product in Ritalin® 10mg Tablets
Me-too-status Ritalin 10 mg Tablet Reg. No. 004458
M/s Novartis Pharma Karachi.
Status is OK.
Decision: Approved and change of brand name.
Bin Qasim, Karachi.
Brand Name + Dosage Form and TimeGesic Sublingual Tablet 0.2 mg
Strength
Composition Each sublingual tablet contains;
Buprenorphine HCl eq. to Buprenoprhine Base 0.2mg
on 07.03.2019.
Pharmacological Group Opioid analgesics, Oripavine derivatives.
ATC Code: N02AE01
Type of form Form-5
Approval status of product in TEMGESIC buprenorphine 200 microgram (as
Reference Regulatory Authorities hydrochloride) sublingual tablet bottle.
TGA Australia Approved.
Me-too-status Enorfine Sublingual Tablets Reg. No. 041527
M/s Munawar Pharma (Pvt) Ltd., 31-Km Multan Road
Lahore.
Status is OK.
Decision: Approved and change of brand name.
Bin Qasim, Karachi.
Dry Powder Suspension (Cephalosporin) Section
Brand Name + Dosage Form and VIOCEF DS Dry Suspension 250mg/5ml
Strength
Composition Each 5 ml after reconstitution contains;
Cefradine B.P .250 mg
on 07.03.2019.
Pharmacological Group First-generation cephalosporins
ATC Code: J01DB09
Type of form Form-5
Approval status of product in Nicef Syrup 250mg/5ml / Cefradine Syrup 250mg/5ml
Me-too-status Cefrinex Suspension 250mg/5ml Reg. No. 015126
Status is OK.
Remark of the Evaluator. The applied product is dry powder for suspension. In
reference RRA approved product, after reconstitution
syrup is formed.
Decision: Approved.
Bin Qasim, Karachi.
SVP Infusion (General) Section
Brand Name + Dosage Form and Moxiflox 400mg/250ml
Strength
Composition Each 250 ml Infusion contains;
Moxifloxacin …400mg as moxifloxacin HCl.
on 07.03.2019.
Pharmacological Group Fluoroquinolones.
ATC Code: J01MA14
Type of form Form-5
Approval status of product in Avelox 400 mg/250 ml solution for infusion
Me-too-status Avelox Infusion Reg. No. 030851
M/s Bayer Pakistan (Pvt.) Ltd. Kot Lakhpat.
Status is OK.
Remark of the Evaluator. Chemical name of product is written as Morphine 10
mg.
Decision: Approved.
368. Name and address of manufacturer/ M/s Trigon Pharmaceuticals (Pvt) Ltd. Raiwind Road,
Applicant Block B LDA Avenue Phase-I, Lahore. (Contract Giver)
(DML No. 000342).
Contract with
M/s English Pharmaceutical Industries. Link Kattar Bund
Road, Thokar Niaz Baig, Multan Road Lahore. (Contract
acceptor) (DML No. 000339)
Brand Name + Dosage Form + ESOMERPRAGON 40mg Injection. (IV)
Strength
Composition Each Vial Contains;
Esomeprazole (as sodium)………… 40mg
Diary No. Date of R & I & fee Dy.No.16133 dated 07-03-2019; Fee Rs.50,000 paid
vide slip No. 1900491 dated 6.03.2019, endorsed on
07.03.2019
ATC Code: A02BC05
Type of Form Form- 5 (Contract Application)
Finished product Specification Innovators Specification
Pack size & Demanded Price As per SRO.
Approval status of product in Reference ESOMEPRAZOLE 40 MG POWDER FOR SOLUTION
Regulatory Authorities FOR INJECTION/INFUSION - PL 55035/0001
MHRA APPROVED.
Me-too status Nexum IV 40mg Injection. Reg. No. 050651
GMP status Last GMP inspection of m/s English pharma, conducted
on 15-07-2022 concludes satisfactory compliance.
Remarks of the Evaluator i. Latest GMP inspection report/certificate of
M/s English Pharma is required.
ii. Copy of DML of M/s Trigon Pharmaceuticals
is required.
iii. Section approval letter of M/s English
Pharmaceuticals is required.
iv. Capacity assessment of M/s English
Pharmaceuticals was conducted on
14.06.2019 for following sections;
o Dry Powder Injectable (Penicillin)
o Liquid ampoule Injectable (General)
o Dry powder Lyophilized Injectable
(General)
o Large Volume Vial Injectable
(General)
Decision: Approved. Registration letter shall be issued after submission of correct address of
applicant along with fee of Rs. 75,000/-.
 Registration Board further authorized its Chairman for issuance of registration letter
upon satisfactory capacity assessment of manufacturing and testing facility of M/s.
English Pharmaceutical Industries, Link Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore.
369. Name and address of manufacturer/ M/s Trigon Pharmaceuticals (Pvt) Ltd. Raiwind Road,
Applicant Block B LDA Avenue Phase-I, Lahore. (Contract Giver)
(DML No. 000342).
Contract with
Brand Name + Dosage Form + OMERPRAGON 40mg Injection. (IV)
Strength
Omeprazole (as sodium)………… 40mg
07.03.2019
ATC Code: A02BC01
Finished product Specification Innovators Specification
Approval status of product in Reference Omeprazole 40mg Powder for Solution for Infusion
Regulatory Authorities (omeprazole sodium) - PL 10622/0232
MHRA APPROVED.
Me-too status Risek 40mg Infusion Reg. No. 024170
GMP status Last GMP inspection of m/s English pharma, conducted
on 15-07-2022 concludes satisfactory compliance.
ii. Copy of DML of M/s Trigon Pharmaceuticals is
required.
Decision: Approved. The registration letter shall be issued after submission of correct
address of applicant along with fee of Rs. 75,000/-.
English Pharmaceutical Industries, Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road, Lahore.
370. Name and address of manufacturer/ M/s Alen Pharmaceuticals, Plot No. 138-A, Nowshera
Applicant Industrial Estate Mardan Road, Risalpur. (Contract Giver)
(DML No. 000435).
&
M/s Bio-Labs (Pvt) Ltd, Plot No. 145 Industrial Triangle,
Kahuta Road, Islamabad (Contract acceptor) (DML No.
000296)
Brand Name + Dosage Form + Allazole 100mg/50ml I.V Infusion
Strength
Fluconazole………………100mg
06.03.2019
Pharmacological Group ANTIMYCOTICS FOR SYSTEMIC USE, Triazole
and tetrazole derivatives.
ATC Code: J02AC01
Finished product Specification USP Specifications
Pack size & Demanded Price 1’s & as per SRO
Approval status of product in Fluconazole 2mg/ml solution for infusion. 50ml,
Reference Regulatory Authorities 100ml, 200ml.
MHRA Approved
Me-too status Could not be verified.
GMP status Last GMP inspection was conducted on 05-12-2017 and
06-12-2017. GMP audit performa stated that Liquid
Infusion 100ml (General) Section was found GMP
compliant. However, GMP certificate was not attached.
Remarks of the Evaluator i.Copy of latest GMP inspection report/ certificate of
M/s Bio-Labs is required is required.
ii. Copy of DML of M/s Alen Pharmaceuticals is
required.
iii. Copy of section approval letter of M/s Bio-Labs is
required.
iv. Me too reference could not be verified. Proper me
too reference is required.
(generic / me-too status) alongwith registration number, brand name and name of firm
371. Name and address of manufacturer/ M/s Ambrosia Pharmaceuticals, Plot no. 18, Street No. 09,
Applicant National Industrial Zone, Rawat. (DML No. 000561)
Brand Name + Dosage Form + Ambstin 10mg Tablet
Strength
Composition Each Film Coated tablet
Ebastine……….10mg
Diary No. Date of R & I & fee Dy. No. 16028 dated 07-03-2019. Fee paid Rs.
20,000/- vide slip No. 1900244 dated 07.03.2019
endorsed on 07.03.2019.
ATC Code: R06AX22
Type of Form Form-5
Finished product Specification JP Specifications.
Approval status of product in Ebastine Viatris 10mg film-coated tablet
Reference Regulatory Authorities ANSM, France Approved.
Me-too status Mestin 10mg Tablet Reg. No. 094054
M/s Metro Pharmaceuticals Rawat.
GMP status Last Panel inspection conducted on 28.12.2021. GMP
status is Good.
Remarks of the Evaluator
Decision: Approved.
372. Name and address of manufacturer/ M/s Ambrosia Pharmaceuticals, Plot no. 18, Street No. 09,
Applicant National Industrial Zone, Rawat. (DML No. 000561)
Brand Name + Dosage Form + Ambstin 20mg tablet.
Strength
Composition Each Film Coated tablet
Ebastine……….20mg
Diary No. Date of R & I & fee Dy. No. 16029 dated 07-03-2019. Fee Paid Rs.
20,000/- vide Slip No. 1900245 dated 07.03.2019.
ATC Code: R06AX22
Type of Form Form-5
Finished product Specification JP Specifications.
Pack size & Demanded Price 10’s, as per SRO
Approval status of product in ALASTINA 20mg
Reference Regulatory Authorities CIMA, Spain Approved.
Me-too status Kestine 20 mg tablet Reg. No. 025432
M/s Highnoon Laboratories Ltd Lahore.
GMP status Last Panel inspection conducted on 28.12.2021. GMP
status is Good.
Decision: Approved.
373. Name and address of manufacturer/ M/s Alfalah Pharma (pvt), Ltd, 12-Km, Sheikhupura Road,
Applicant Lahore (contract giver) (DML No. 000461)
M/s Synchro Pharmaceuticals, 77-Industrial Estate, Kot
Lakhpat, Lahore (Contract Acceptor) (DML No. 000575)
Dry Powder Suspension (Cephalosporin)
Brand Name + Dosage Form + Vasix Dry Suspension 200mg/5ml
Strength
Cefixime Trihydrate equivalent to Cefixime 200mg
Diary No. Date of R & I & fee Dy. No. 16421 dated 07.03.2019. Fee paid Rs.
50,000/- vide Slip No. 0795641 dated 06-03-2019,
Pharmacological Group Third-generation cephalosporins.
ATC Code: J01DD08
Type of Form Form-5 (Contract manufacturing)
Finished product Specification USP Specification
Pack size & Demanded Price 01×30ml as per SRO
Approval status of product in Suprax 200mg/5ml
Me-too status Cefspan D.S Suspension Reg. No. 024634
GMP status Last inspection conducted on 22.01.21
Decision: Approved.
374. Name and address of manufacturer/ M/s Fresh Pharmaceuticals Plot No. 7 St. no. S-6, National
Applicant Industrial Zone RCCI Rawat. (Contract Giver) (DML No.
000827).
Contract with
M/s Vision Pharmaceuticals, Plot No. 22-23, Industrial
Triangle, Kahuta Road Islamabad. (Contract acceptor)
(DML No. 000517)
Injection (General) Section.
Brand Name + Dosage Form + CHEMSET 8mg/4ml Injection (IV/IM)
Strength
Ondansetron hydrochloride dehydrate eq. to Ondansetron
…………8mg
06.03.2019
Pharmacological Group ANTIEMETICS AND ANTINAUSEANTS, Serotonin
(5HT3) antagonists
ATC Code: A04AA01
Finished product Specification USP Specifications.
Pack size & Demanded Price 4ml x 5’s. As per SRO.
Approval status of product in ONDANSETRON 8MG/4ML INJECTION
Reference Regulatory Authorities (ONDANSETRON HYDROCHLORIDE)
PL 04543/0508
MHRA APPROVED.
Me-too status Periset 4ml injection Reg. No. 090250
M/s Linear Pharma Islamabad.
GMP status Last inspection conducted on 28.10.2020. GMP Status is
good.
Remarks of the Evaluator i. Copy of DML of M/s Fresh Pharma is
required.
ii. Copy of Section Approval letter of M/s Vision
Pharma is required.
iii. Form-5 filled and signed by M/s Fresh Pharma is
required.
iv. Capacity assessment inspection of M/s Vision
Pharmaceutical (DML No. 000517) was
conducted on 15.06.2022 for following sections;
a. Sterile Dry Powder Vial (General)
b. Sterile Dry Powder Injection Vial (Steroid)
Decision: Deferred for submission of Form-5 by M/s Fresh Pharmaceuticals along with fee of
Rs. 75,000/- as per notification No. 7-11/2012-B&A/DRAP dated 07.05.2021.
375. Name and address of manufacturer/ M/s Inventor Pharma, Plot No. K-196, SITE (SHW) PH-II,
Applicant Karachi. (Contract Giver) (DML No. 000866).
Contract with
(DML No. 000517)
Dry Powder Injection (Steroid) Section.
Brand Name + Dosage Form + NEOCARTIF 100mg Inejction (IV)
Strength
Hydrocortisone Sodium Succinate equivalent to
Hydrocortisone………100mg
06.03.2019
Pharmacological Group CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN,
Glucocorticoids.
ATC Code: H02AB09
Pack size & Demanded Price 1’s. As per SRO
Approval status of product in SOLU-CORTEF 100MG, HYDROCORTISONE 100 MG
Reference Regulatory Authorities POWDER FOR SOLUTION FOR INJECTION OR
INFUSION.
MHRA APPROVED.
Me-too status Hyzonate Injection 100mg Reg. No. 019228
M/s Amson Vaccines & Pharma (Pvt.) Ltd. Islamabad.
good.
Remarks of the Evaluator i.Capacity assessment inspection of M/s Vision
Decision: Approved with change of brand name.
Contract with
(DML No. 000517)
Sterile Dry Powder Injectable vial (General) Section.
Brand Name + Dosage Form + PROMEP 40mg IV Injection
Strength
Esomeprazole as Sodium…….40mg
06.03.2019
Pharmacological Group Proton pump inhibitors,
ATC Code: A02BC05
Finished product Specification Innovator’s Specifications.
Pack size & Demanded Price 1’s As per SRO.
Approval status of product in ESOMEPRAZOLE 40 MG POWDER FOR SOLUTION
Reference Regulatory Authorities FOR INJECTION/INFUSION - PL 55035/0001
MHRA APPROVED.
Me-too status Nexum IV 40mg Injection Reg. No. 050651
good.
Remarks of the Evaluator i. Capacity assessment inspection of M/s Vision
conducted on 15.06.2022 for following
sections;
Decision: Approved.
Contract with
(DML No. 000517)
Sterile Dry Powder Injectable vial (General) Section.
Brand Name + Dosage Form + OMETEK 40mg IV Injection
Strength
Omeprazole as Sodium ……………. 40mg
06.03.2019
Pharmacological Group Proton pump inhibitors,
ATC Code: A02BC01
Finished product Specification Innovator’s Speceifications.
Approval status of product in Omeprazole 40mg Powder for Solution for Infusion
Reference Regulatory Authorities (omeprazole sodium) - PL 10622/0232
MHRA Approved.
Me-too status Risek 40mg Infusion Reg. No. 024170
good.
Remarks of the Evaluator i. Capacity assessment inspection of M/s Vision
conducted on 15.06.2022 for following
sections;
Decision: Approved.
378. Name and address of manufacturer/ M/s Winilton Pharmaceuticals (Pvt.) Ltd. Plot No. 45 St.
Applicant No. S-5, National Industrial Zone RCCI Rawat. (Contract
Giver) (DML No. 000721).
Contract with
(DML No. 000517)
Brand Name + Dosage Form + WINDSTON 8mg/4ml Injection (IV/IM)
Strength
Ondansetron hydrochloride dehydrate eq. to Ondansetron
…………8mg
06.03.2019
(5HT3) antagonists
ATC Code: A04AA01
Pack size & Demanded Price 4ml x 5’s. As per SRO.
Approval status of product in ONDANSETRON 8MG/4ML INJECTION
Reference Regulatory Authorities (ONDANSETRON HYDROCHLORIDE)
PL 04543/0508
MHRA APPROVED.
Me-too status Periset 4ml injection Reg. No. 090250
M/s Linear Pharma Islamabad.
good.
Remarks of the Evaluator ii.Copy of DML of M/s Winilton Pharma is required.
iii.Copy of Section Approval letter of M/s Vision
Pharma is required.
iv.Capacity assessment inspection of M/s Vision
Decision: Approved. Registration Board further authorized its Chairman for issuance of
registration letter upon capacity assessment of manufacturing and testing facility of M/s Vision
Pharmaceuticals.
379. Name and address of manufacturer/ M/s Winilton Pharmaceuticals (Pvt.) Ltd. Plot No. 45 St.
Applicant No. S-5, National Industrial Zone RCCI Rawat. (Contract
Contract with
(DML No. 000517)
Brand Name + Dosage Form + WINMOX 400mg/250ml IV Infusion.
Strength
Moxifloxacin Hydrochloride equivalent to Moxifloxacin
……………. 400mg
06.03.2019
Pharmacological Group Fluoroquinolones
ATC Code: J01MA14.
Finished product Specification Manufacturer’s Specifications.
Pack size & Demanded Price 1x250ml. As per SRO.
Approval status of product in MOXIFLOXACIN 400 MG/250 ML SOLUTION FOR
Reference Regulatory Authorities INFUSION - PL 24598/0022; UK/H/4829/001/DC.
MHRA APPROVED.
Me-too status Avelox Infusion Reg. No. 109733
M/s Bayer Pakistan Kot Lakhpat.
good.
Remarks of the Evaluator v.Capacity assessment inspection of M/s Vision
c. Sterile Dry Powder Vial (General)
d. Sterile Dry Powder Injection Vial (Steroid)
registration letter upon capacity assessment of manufacturing and testing facility of M/s
Vision Pharmaceuticals.
380. Name and address of manufacturer/ M/s Nimrall Laboratories, Plot No. 24, St. No. SS-3,
Applicant National Industrial Zone, Rawat. (Contract Giver) (DML
No. 000611).
Contract with
(DML No. 000517)
Brand Name + Dosage Form + METHRALL 1M IU Injection (IV)
Strength
Colistimethate Sodium dry powder ….1Million I.U
06.03.2019
(5HT3) antagonists
ATC Code: A04AA01
Pack size & Demanded Price 1’s. As per SRO.
Approval status of product in COLISTIMETHATE SODIUM 1 MIU POWDER FOR
Reference Regulatory Authorities SOLUTION FOR INJECTION/INFUSION - PL
24598/0091
MHRA Approved.
Me-too status Stacolmi 1MIU Injection Reg. No. 106475
M/s Stallion Pharmaceuticals Lahore.
good.
Remarks of the Evaluator i. Copy of DML of M/s Nimrall Pharma is
required.
ii.Copy of Section Approval letter of M/s Vision
Pharma is required.
iii.Capacity assessment inspection of M/s Vision
Decision: Approved. Firm will revise the label claim as per the decision taken by the Board in
instant meeting regarding Review of Colistimethate for Injection along with submission of
requisite fee for pre-registration correction/changes of label claim as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
381. Name and address of manufacturer/ M/s Kohinoor Industries 160/B, Small Industries Estate
Applicant Sahiwal. (Contract Giver) (DML No. 000197).
Contract with
Dry Powder for Injection (Cephalosporin) Section.
Brand Name + Dosage Form + KOXONE 250mg Injection (IM)
Strength
Ceftriaxone as Sodium ……..250mg
07.03.2019
ATC Code: J01DD04
Finished product Specification BP Specifications.
Approval status of product in Ceftriaxone 250mg Powder for Solution for Injection
Reference Regulatory Authorities - PL 24598/0006.
MHRA Approved.
Me-too status Rocephin IM Inj Reg. No. 008432
GMP status Last GMP inspection was conducted on 16.01.2018.
ii. Copy of DML of M/s Kohinoor Industries is
required.
Pharmaceuticals was conducted on 14.06.2019 for
following sections;
a. Dry Powder Injectable (Penicillin)
b. Liquid ampoule Injectable (General)
c. Dry powder Lyophilized Injectable (General)
d. Large Volume Vial Injectable (General)
registration letter upon satisfactory capacity assessment of manufacturing and testing facility
of M/s. English Pharmaceutical Industries, Link Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore.
Contract with
Brand Name + Dosage Form + KOXONE 500mg Injection (IM)
Strength
Ceftriaxone as Sodium ……..500mg
07.03.2019
ATC Code: J01DD04
Approval status of product in Ceftriaxone 250mg, 500mg and 1g Powder for
Reference Regulatory Authorities Solution for Injection and 2g Pwder for Solution for
Injection or Infusion - PL 22805/0001, 3-5
MHRA Approved.
required.
Pharmaceuticals was conducted on 14.06.2019
for following sections;
(General)
(General)
Road, Lahore.
Contract with
Brand Name + Dosage Form + KOXONE 1g Injection. (IV)
Strength
Ceftriaxone as Sodium………………1gm
07.03.2019
ATC Code: J01DD04
Pack size & Demanded Price As per SRO
Approval status of product in Ceftriaxone 1g Powder for Solution for Injection or
Reference Regulatory Authorities Infusion (ceftriaxone sodium) - PL 42671/0001
MHRA Approved.
Me-too status Rocephin IV Inj. Reg. No. 008437
M/s Roche Pakistan Ltd. Karachi.
required.
(General)
(General)
Road, Lahore.
Contract with
Brand Name + Dosage Form + KO-XIME 100mg/5ml Suspension
Strength
Cefixime …..100mg
07.03.2019
Pharmacological Group Third-generation cephalosporins
ATC Code: J01DD08
Approval status of product in Cefixime 100 mg/5 mL Powder for Oral Suspension -
Reference Regulatory Authorities PL 04569/1118; UK/H/2828/001/DC
MHRA Approved.
Me-too status Fixicef Powder for oral suspension Reg. No. 080273
required.
iv. The products approved in RRA are using
trihydrate, the label of applied product does
not mention the hydrate of Cefixime.
Justification or correction is required is along
with submission of requisite fee (Full Fee).
v. Capacity assessment of M/s English
(General)
(General)
Decision: Approved with following label claim;
Each 5mL contains;
Cefixime as trihydrate equivalent to Cefixime …….100mg
 Registration letter shall be issued after submission of fee Rs. 75,000/- vide
Notification No. 7-11/2012-B&A/DRAp dated 07.05.2021.
Contract with
Brand Name + Dosage Form + KO-XIME 200mg/5ml Suspension.
Strength
Cefixime …………200mg
07.03.2019
ATC Code: J01DD08
Finished product Specification USP Specifiations.
Approval status of product in Cefixime 200mg/5ml for Suspension; Oral. By Alkem
Reference Regulatory Authorities Labs ltd.
USFDA Approved.
Me-too status Cefspan DS Suspension Reg. No. 024634
required.
(General)
(General)
Each 5mL contains;
Notification No. 7-11/2012-B&A/DRAp dated 07.05.2021
Contract with
Brand Name + Dosage Form + RA-D 200,000IU Injection
Strength
Composition Each 1ml Ampoule contains;
Vitamin D3 (Cholecalciferol)………200,000IU
07.03.2019
Pharmacological Group Vitamin D and analogues
ATC Code: A11CC05
Approval status of product in VITAMIN D3 BON 200,000 IU/1 ml solution for
Reference Regulatory Authorities injection IM ampoule
ANSM France Approved.
Me-too status Sunny D Insta Ampoule Reg. No. 063450
M/s Scotmann Pharmaceuticals Islamabad.
required.
(General)
(General)
Decision: Approved with Innovator’s specifications. The firm shall submit fee of Rs. 7500/-
for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-202.
Contract with
Brand Name + Dosage Form + KO-XIME 400mg Capsule
Strength
Cefixime …………400mg
07.03.2019
ATC Code: J01DD08
Approval status of product in Suprax (Cefixime) Capsules 400mg
Me-too status Cefspan 400mg Capsules Reg. No. 013860
required.
o Liquid ampule Injectable (General)
(General)
(General)
Each Capsule contains;
Notification No. 7-11/2012-B&A/DRAp dated 07.05.2021
 Registration Board further authorized its Chairman for issuance of registration
letter upon capacity assessment of manufacturing and testing facility of M/s
English Pharmaceutical Industries. Link Kattar Bund Road, Thokar Niaz Baig,
Multan Road Lahore.
388. Name and address of manufacturer/ M/s Dr. Raza Pharma, 44-C, Industrial Estate, Hayatabad,
Applicant Peshawar (Contract Giver) (DML No. 000827).
Contract with
M/s Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205,
Industrial Triangle Kahuta Road Islamabad. (Contract
Dry Powder Injection (Penicillin) Section.
Brand Name + Dosage Form + RAZABACT 2.25gram Injection (IV)
Strength
Sterile Piperacillin Sodium equivalent to
Piperacillin…………2.0gm
Sterile Tazobactam Sodium equivalent to
Tazobactam………...0.25gm
06.03.2019
Pharmacological Group Combinations of penicillins, incl. beta-lactamase
inhibitors.
ATC Code: J01CR05
Approval status of product in PIPERACILLIN/TAZOBACTAM 2 G/ 0.25 G POWDER
Reference Regulatory Authorities FOR SOLUTION FOR INJECTION OR INFUSION - PL
28176/0045
MHRA APPROVED.
Me-too status Tanzo 2.25gm Inj Reg. No. 039593
M/s Bosch Pharmaceuticals Karachi..
good.
Remarks of the Evaluator The panel has conducted capacity assessment of the
firm, M/s Global Pharmaceuticals on 21.10.2022 for
following sections and has submitted report to PE&R
Division for further processing:
1. Dry Powder Injection (Cephalosporin)
2. Dry Powder Injection (Penicillin)
3. Dry Powder Injection (Carbapenem)
4. Liquid Injection Ampoule (General)
registration letter upon consideration of satisfactory capacity assessment of manufacturing and
testing facility of M/s Global Pharmaceuticals.
389. Name and address of manufacturer/ M/s Dr. Raza Pharma, 44-C, Industrial Estate, Hayatabad,
Applicant Peshawar (Contract Giver) (DML No. 000827).
Contract with
Brand Name + Dosage Form + RAZABACT 4.5gram Injection (IV)
Strength
06.03.2019
inhibitors.
ATC Code: J01CR05
28176/0046
MHRA APPROVED.
good.
000827).
Contract with
Dry Powder Injection (Carbapenem) Section.
Brand Name + Dosage Form + MEPNAM INJECTION 500mg/500mg IV
Strength
Imipenem Monohydrate eq. to Imipenem …….. 500mg
Cilastatin Sodium eq. to Colastatin …… 500mg
06.03.2019
Pharmacological Group Carbapenems
ATC Code: J01DH51
Finished product Specification USP specifications.
Approval status of product in IMIPENEM/CILASTATIN 500/500MG POWDER FOR
Reference Regulatory Authorities SOLUTION FOR INFUSION (IMIPENEM,
CILASTATIN SODIUM) - UK/H/1409/001/DC; PL
14894/0665
MHRA APPROVED.
Me-too status Imclas Inj IV Reg. No. 048341
M/s Global Pharmaceuticals Islamabad.
good.
Decision: Approved.
 M/s Global shall use 10ml 0.9% NaCl injection as diluent for the commercial batches
and submit compatibility study with the 0.9%NaCl solution as diluent along with BMR
of recently manufactured batches from M/s Global Pharmaceuticals, as evidence of use
of the recommended diluent before issuance of Registration letter.
 Firm shall use correct fill weight per vial considering the sodium content as per the
drug substance manufacturer’s claim for the commercial batches and submit BMR of
recently manufactured batches from M/s Global Pharmaceuticals as evidence of
correct fill weight before issuance of Registration letter.
upon consideration of satisfactory capacity assessment of manufacturing and testing
facility of M/s Global Pharmaceuticals.
000827).
Contract with

Dry Powder Injection (Cephalosporin) Section
Brand Name + Dosage Form + CEFSUL 1gm Injection (IV/IM)
Strength
Cefoperazone Sodium USP equivalent to
Cefoperazone………….. 500mg
Sulbactum Sodium USP equivalent to
Sulbactam………….…..500mg
06.03.2019
Pharmacological Group Third-generation cephalosporins, cefoperazone and beta-
lactamase inhibitor.
ATC Code: J01DD62
Finished product Specification Global Specifications.
Approval status of product in SULPERAZONE FOR INTRAVENOUS INJECTION 1G
Reference Regulatory Authorities PDMA JAPAN APPROVED.
Me-too status Q-Bact 1gm Injection Reg. No. 061169
M/s High-Q International Karachi.
good.
000827).
Contract with
Dry Powder Injection (Cephalosporin) Section.
Brand Name + Dosage Form + CEFSUL 2gm Injection (IV/IM)
Strength
Cefoperazone Sodium USP equivalent to Cefoperazone
………….. 1000mg
Sulbactum Sodium USP equivalent to
Sulbactam………….…..1000mg
06.03.2019
ATC Code: J01DD62
Finished product Specification Global Specifications.
Approval status of product in Approved in 03 European countries, i.e., Czech
Reference Regulatory Authorities Republic, Poland and Slovakia
Me-too status Q-Bact 2gm Injection Reg. No. 061170
M/s High-Q International Karachi.
good.
000827).
Contract with
Brand Name + Dosage Form + CEFER 250mg Injection (IM)
Strength
Ceftriaxone Sodium eq. to Ceftriaxone ….. 250mg
06.03.2019
ATC Code: J01DD04
Approval status of product in CEFTRIAXONE 250MG POWDER FOR SOLUTION
Reference Regulatory Authorities FOR INJECTION - PL 24598/0006
MHRA APPROVED.
good.
000827).
Contract with
Brand Name + Dosage Form + CEFER 500mg Injection (IV)
Strength
Ceftriaxone Sodium eq. to Ceftriaxone …... 500mg
06.03.2019
ATC Code: J01DD04
Approval status of product in CEFTRIAXONE 500 MG POWDER FOR SOLUTION
Reference Regulatory Authorities FOR INJECTION - PL 41947/0018; UK/H/6066/001/DC
MHRA APPROVED.
Me-too status Rocephin IV Inj Reg. No. 008435
good.
000827).
Contract with
Brand Name + Dosage Form + CEFER 500mg Injection (IM)
Strength
06.03.2019
ATC Code: J01DD04
Approval status of product in CEFTRIAXONE 500 MG POWDER FOR SOLUTION
Reference Regulatory Authorities FOR INJECTION - PL 41947/0018; UK/H/6066/001/DC
MHRA APPROVED.
good.
000827).
Contract with
Brand Name + Dosage Form + CEFER 1gm Injection (IV)
Strength
06.03.2019
ATC Code: J01DD04
Approval status of product in CEFTRIAXONE 1 G AND 2 G POWDER FOR
Reference Regulatory Authorities SOLUTION FOR INJECTION/INFUSION - PL
41947/0019-0020; UK/H/6066/002-003/DC
MHRA APPROVED.
Me-too status Rocephin IV Inj Reg. No. 008437
M/s Roche Ltd. Karachi.
good.
000827).
Contract with
Tablet (General) Section.
Brand Name + Dosage Form + RENAPHAS 10mEq Tablets
Strength
Potassium Citrate……10mEq (1080mg)
06.03.2019
Pharmacological Group MINERAL SUPPLEMENTS, Potassium. (Potassium
citrate preparations indicated for e.g. treatment of renal
tubular acidosis with calcium stones)
ATC Code:A12BA02
Pack size & Demanded Price 10’s & 30’s. As per SRO.
Approval status of product in Urocit-, 5mEq, 10mEq, 15mEq Extended-release tablets
Reference Regulatory Authorities USFDA Approved
Me-too status Exocite XR 10mEq tablets Reg. No. 080827
M/s Vision Pharmaceuticals Islamabad.
good.
registration letter upon capacity assessment of manufacturing and testing facility for “Tablet
(general) section” of M/s Global Pharmaceuticals.
398. Name and address of manufacturer/ M/s Inventor Pharma, Plot No. K/196 SITE (SHW) PH-II
Contract with
Brand Name + Dosage Form + MEROPEN INJECTION 500mg (IV)
Strength
Meropenem USP….….. 500mg
06s.03.2019
ATC Code: J01DH02
Approval status of product in MEROPENEM 500 MG AND 1 G POWDER FOR
Reference Regulatory Authorities SOLUTION FOR INJECTION OR INFUSION
(MEROPENEM) - UK/H/4098/001-2/DC; PL
34985/0003-4
MHRA APPROVED.
Me-too status Meronem IV 500mg Injection Reg. No. 096203
M/s Pfizer Pakistan.
good.
Remarks of the Evaluator i. Label claim is without consideration of
hydrated form of the API. Justification or
correction of label claim is required for
consideration of hydrated form of API along
with submission of requisite fee (full fee)
“Each Vial Contains:
Meropenem Trihydrate Eq. To Meropenem…500mg”
 Registration letter shall be issued after submission of fee Rs. 75,000/- as per Notification
No. 7-11/2012-B&A dated 07.05.2021.
 Firm shall state the quantity, in mg, of sodium (Na) in a given dosage of Meropenem,
on the label claim, as recommended by the USP monograph of “Meropenem for
injection”.
399. Name and address of manufacturer/ M/s Inventor Pharma, Plot No. K/196 SITE (SHW) PH-II
Contract with
Brand Name + Dosage Form + MEROPEN INJECTION 1000mg (IV)
Strength
Meropenem USP……... 1gm
06.03.2019
ATC Code: J01DH02
Approval status of product in MEROPENEM 500 MG AND 1 G POWDER FOR
Reference Regulatory Authorities SOLUTION FOR INJECTION OR INFUSION
(MEROPENEM) - UK/H/4098/001-2/DC; PL
34985/0003-4
MHRA APPROVED.
Me-too status Meronem IV 500mg Injection Reg. No. 096203
good.
Remarks of the Evaluator i. Label claim is without consideration of
hydrated form of the API. Justification or
correction of label claim is required for
consideration of hydrated form of API along
with submission of requisite fee (full fee)
“Each Vial Contains:
Meropenem Trihydrate Eq. To Meropenem….1gm”
 Firm shall state the quantity, in mg, of sodium (Na) in a given dosage of Meropenem,
on the label claim, as recommended by the USP monograph of “Meropenem for
injection”.
No. 7-11/2012-B&A dated 07.05.2021
400. Name and address of manufacturer/ M/s Medicraft Pharmaceutical (Pvt.) Ltd. 126-B, Industrial
Applicant Estate, Hayatabad, Peshawar. (Contract Giver) (DML No.
000390).
Contract with
Brand Name + Dosage Form + TAZOCRAFT 2.25gram Injection (IV)
Strength
Diary No. Date of R & I & fee Dy.No. 16941 dated 07-03-2019; Fee Rs.50,000 paid
06.03.2019
inhibitors.
ATC Code: J01CR05
28176/0045
MHRA APPROVED.
good.
401. Name and address of manufacturer/ M/s Medicraft Pharmaceutical (Pvt.) Ltd. 126-B, Industrial
Applicant Estate, Hayatabad, Peshawar. (Contract Giver) (DML No.
000390).
Contract with
Brand Name + Dosage Form + TAZOCRAFT 4.5gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0046
MHRA APPROVED.
good.
402. Name and address of manufacturer/ M/s Meditech Pharmaceuticals 15-D Industrial Estate,
Applicant Hayatabad, Peshawar. (Contract Giver) (DML No. ).
Contract with
Brand Name + Dosage Form + MEDIBACT 2.25gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0045
MHRA APPROVED.
good.
Remarks of the Evaluator i. Copy of DML of M/s Meditech Pharma is
required.
Decision: Deferred for clarification as the DML site of M/s Meditech Pharmaceuticals has been
changed to Plot No. 83-A, 83-B, Indusytrail Estate, Hayatabad, Peshawar, whereas the instant
application has been applied from previous site.
403. Name and address of manufacturer/ M/s Meditech Pharmaceuticals 15-D Industrial Estate,
Applicant Hayatabad, Peshawar. (Contract Giver)
Contract with
Brand Name + Dosage Form + MEDIBACT 4.5gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0046
MHRA APPROVED.
good.
Remarks of the Evaluator i. Copy of DML of M/s Meditech Pharma is
required.
Decision: Deferred for clarification as the DML site of M/s Meditech Pharmaceuticals has been
changed to Plot No. 83-A, 83-B, Indusytrail Estate, Hayatabad, Peshawar, whereas the instant
application has been applied from previous site.
404. Name and address of manufacturer/ M/s Nimrall Laboratories, Plot No. 24, St. No. SS-3, Rawat
Applicant Industrial Zone, Rawat. (Contract Giver) (DML No.
000611).
Contract with
Brand Name + Dosage Form + PIPRAL-T 2.25gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0045
MHRA APPROVED.
good.
registration letter upon consideration of satisfactory capacity assessment of manufacturing
and testing facility of M/s Global Pharmaceuticals.
000611).
Contract with
Brand Name + Dosage Form + IMEI Injection 500mg (IV)
Strength
Imipenem monohydrate eq. to Imipenem …250mg
Cilastatin Sodium eq. to Cilastatin ………..250mg
07.03.2019
ATC Code: J01DH51
Approval status of product in IMIPENEM/CILASTATIN 250MG/250MG AND
Reference Regulatory Authorities 500MG/500MG POWDER FOR SOLUTION FOR
INFUSION - UK/H/1704/001-002/DC; PL 30306/0112-3
MHRA APPROVED.
Me-too status Cilnem 250mg Injection IV Reg. No. 094314
M/s Nicholas Pharma Rawat.
good.
Decision: Approved.
000611).
Contract with
Brand Name + Dosage Form + IMEI Injection 1gm (IV)
Strength
Imipenem monohydrate eq. to Imipenem …500mg
Cilastatin Sodium eq. to Cilastatin ………..500mg
07.03.2019
ATC Code: J01DH51
Approval status of product in IMIPENEM/CILASTATIN 250MG/250MG AND
Reference Regulatory Authorities 500MG/500MG POWDER FOR SOLUTION FOR
INFUSION - UK/H/1704/001-002/DC; PL 30306/0112-3
MHRA APPROVED.
Me-too status Cilnem 500mg Injection IV Reg. No. 094315
M/s Nicholas Pharma Rawat.
good.
Decision: Approved.
407. Name and address of manufacturer/ M/s Panacea Pharmaceuticals, Plot No. 4, St. No. S-6,
Applicant National Industrial Zone Rawat. (Contract Giver) (DML
No. 000600).
Contract with
Brand Name + Dosage Form + PAPRA 4.5gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0046
MHRA APPROVED.
good.
408. Name and address of manufacturer/ M/s Treat Pharmaceutical Industry (Pvt.) Ltd. A-37 Small
Applicant Industrial Estate Township, Kohat Road Bannu. (Contract
Contract with
Brand Name + Dosage Form + TREATBACT 2.25gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0045
MHRA APPROVED.
good.
409. Name and address of manufacturer/ M/s Winilton Pharmaceutical (Pvt.) Ltd. , Plot No. 45, St.
Applicant No. S-5, Rawat Industrial Zone, Rawat. (Contract Giver)
(DML No. 000721).
Contract with
Brand Name + Dosage Form + PIPRAWIN 4.5gram Injection (IV)
Strength
07.03.2019
inhibitors.
ATC Code: J01CR05
28176/0046
MHRA APPROVED.
good.
410. Name and address of manufacturer/ M/s CSH Pharmaceuticals (Pvt.) Ltd. 32-KM Ferozpur
Applicant Road Lahore. (Contract Giver) (DML No. 000737).
Contract with
M/s Medisave Pharmaceuticals, Plot No. 578-579, Sundar
Industrial Estate, Sundar Raiwind Road Lahore. (Contract
Brand Name + Dosage Form + BETACAM 20mg Tablets
Strength
Composition Each Dispersible Tablet Contains;
Piroxicam beta cyclodextrin……………20mg
07.03.2019
PRODUCTS, NON-STEROIDS, Oxicams
ATC Code: M01AC01
Finished product Specification Manufacturers Specifications.
Approval status of product in BREXIN 20 MG EFFERVESCENT TABLET
Reference Regulatory Authorities ANSM FRANCE APPROVED.
Me-too status Straza Tablet Reg. No. 096316
M/s Asian Continental Karachi.
M/s Medisave Pharma is required.
ii. The strength of active with complex combined is
mentioned as 20mg. The label claim needs to be
revised for only strength of active (as complex)
along with submission of requisite fee (Full Fee).
iii. Firm has referred to the Capacity assessment
inspection report of M/s. Medisave
pharmaceuticals, Lahore presented in 317th
meeting of Registration Board wherein Board
decided to allow contract manufacturing from M/s
Medisave Pharmaceuticals, Plot 578-579, Sundar
Industrial Estate, Lahore for following sections:
 General Tablet Section (General),
 Capsule Section (Cephalosporin)
 Dry Powder Suspension Section
(Cephalosporin)
 Dry Powder Injection Section
(Cephalosporin)
 Liquid Injection
 Infusion (LVP) Section
 Liquid Syrup Section
“Each Dispersible Tablet Contains;
Piroxicam beta cyclodextrin Eq. to Piroxicam……20mg”
No. 7-11/2012-B&A dated 07.05.2021 for correction/pre-approval change of the
composition of product.
 As decided in 317th meeting of Registration Board, M/s Medisave Pharmaceuticals shall
submit compliance report from the contract manufacturer i.e, for further increase in
testing capacity especially HPLC, microbiological testing etc before issuance of
Contract with
Brand Name + Dosage Form + CEFABACT PLUS 1g Injection (IV/IM)
Strength
Cefoperazone Sodium USP……..500mg
Sulbactam Sodium USP………...500mg
07.03.2019
ATC Code: J01DD62
Approval status of product in Sulperazon Injection, Pfizer Inc. PMDA Approved
Me-too status 2Sum Injection 1g Reg. No. 047002
M/s Sami Pharmaceuticals
ii. Evidence of approval of applied product in
RRA is required.
iii. The reference product contains Cefoperazone
As Sodium and Sulbactam As Sodium (0.5g
each) while the applied product contains
Cefoperazone Sodium and Salbactum Sodium
(0.5g each), clarify or otherwise submit
revised formulation with correct equivalency
factor along with the submission of requisite
fee (Full Fee).
iv. Firm has referred to the Capacity assessment
decided to allow contract manufacturing from
M/s Medisave Pharmaceuticals, Plot 578-579,
Sundar Industrial Estate, Lahore for following
sections:
(Cephalosporin)
(Cephalosporin)
“Each Vial Contains;
Cefoperazone as Sodium USP……..500mg
Sulbactam as Sodium USP………...500mg “
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + CEFABACT PLUS 2g Injection (IM/IV)
Strength
Cefoperazone Sodium USP……..1000mg
Sulbactam Sodium USP………...1000mg
07.03.2019
ATC Code: J01DD62
Approval status of product in Approved in 03 European countries, i.e., Czech
Reference Regulatory Authorities Republic, Poland and Slovakia
Me-too status 2Sum Injection 2g Reg. No. 047003
M/s Healthtek Karachi.
Remarks of the Evaluator i. Latest GMP inspection report/certificate of M/s
Medisave Pharma is required.
i. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
Each Vial Contains;
Cefoperazone as Sodium USP……..1000mg
Sulbactam as Sodium USP………...1000mg
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + CEFTIMAX 250mg Injection (IM/IV)
Strength
Ceftriaxone Sodium……………250mg
07.03.2019
ATC Code: J01DD04
MHRA Approved.
Me-too status Zetox 250mg Injection Reg. No. 053144
M/s Lahore Pharma.
ii. The reference product contains Ceftriaxone as
Sodium and while the applied product contains
Ceftriaxone Sodium. Clarify or otherwise submit
factor along with the submission of requisite fee
(Full Fee).
ii. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
Ceftriaxone as Sodium……………250mg”
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + CEFTIMAX 200mg Injection (IM/IV)
Strength
Ceftriaxone Sodium……………500mg
07.03.2019
ATC Code: J01DD04
MHRA Approved.
Me-too status Zetox 500mg Injection Reg. No. 053145
M/s Lahore Pharma.
(Full Fee).
iii. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
Ceftriaxone as Sodium……………500mg”
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + CEFTIMAX 1g Injection (IV/IM)
Strength
Ceftriaxone Sodium USP………1000mg
07.03.2019
ATC Code: J01DD04
Pack size & Demanded Price 1s, As per SRO.
MHRA Approved.
Me-too status Rocephin IV/IM Injection 1gm Reg. No. 007014
(Full Fee).
iv. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
Each Vial Contains;
Ceftriaxone as Sodium USP………1000mg
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + KETOCARE 30mg/1ml Injection (IV)
Strength
Ketorolac Trometamol BP………30mg
07.03.2019
ATC Code: M01AB15
Pack size & Demanded Price 5 ampoules of 1ml each. As per SRO.
Me-too status Cadlec 30mg/ml Injection IM/IV Reg. No. 095892
M/s Brookes Pharma Karachi.
v. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
 Liquid Syrup Section.
Decision: Deferred for clarification of sterilisation method used for the applied formulation.
Contract with
Brand Name + Dosage Form + MECAL 500mcg/ml Injection (IM)
Strength
Mecobalamine ……………500mcg
07.03.2019
Pharmacological Group Vitamin B12 (cyanocobalamin and analogues).
ATC Code: B03BA05
Finished product Specification Manufacturers Specifications.
Approval status of product in METHYCOBAL 500µginjection
Reference Regulatory Authorities PDMA Japan Approved.
Me-too status Mecomed 500mcg Reg. No. 041670
M/s Global Pharma Islamabad.
vi. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
Decision: Approved with Innovator’s specifications.
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + MEFLOX 400mg/250ml Infusion
Strength
Composition Each ml contains;
Moxifloxacin HCl………..1.6mg
07.03.2019
ATC Code: J01MA14
Pack size & Demanded Price 250ml, As per SRO.
Approval status of product in MOXIFLOXACIN 400 MG/250 ML SOLUTION FOR
Reference Regulatory Authorities INFUSION - PL 24598/0022; UK/H/4829/001/DC
MHRA APPROVED.
Me-too status Avelox Infusion Reg. No. 109733
M/s Bayer Pakistan Kot Lakhpat.
ii. In pack size, 2 volumes are mentioned (100ml and
250ml). By changing volume amount of drug per
infusion changes so different volume needs to be
applied separately.
iii. The strength in label claim is of combined drug
and its HCl. The label needs to be revised to
mention equivalent strength of drug as its HCl salt.
Requisite for correction is also required (Full Fee)
Decision: Deferred for submission of correct Form-5 along with correct details of applied
product and applicable full fee as per notification No. F.7-11/2012-B&A/DRAP dated
07.05.2021.
Contract with
Brand Name + Dosage Form + TRICEF 400mg Capsules
Strength
Cefixime trihydrate……….. 400mg
07.03.2019
ATC Code: J01DD08
Approval status of product in SUPRAX (CEFIXIME) CAPSULES 400MG
Reference Regulatory Authorities USFDA APPROVED.
Me-too status Cefspan 400mg Capsules Reg. No. 013860
ii. The strength of applied product is 400mg with
hydrate included. The strength of approved
products in RRA and as me-too have strength of
active 400 mg as trihydrate. Correction is required
along with submission of requisite fee (Full Fee)
vii. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
Each Capsule Contains;
Cefixime trihydrate equivalent to Cefixime……….. 400mg
 Registration letter shall be issued after submission of fee Rs. 75,000/- as per
Notification No. 7-11/2012-B&A dated 07.05.2021
 As decided in 317th meeting of Registration Board, M/s Medisave Pharmaceuticals
shall submit compliance report from the contract manufacturer i.e, for further
increase in testing capacity especially HPLC, microbiological testing etc before
issuance of registration letter.
Contract with
Brand Name + Dosage Form + TRICEF 100mg Suspension
Strength
Cefixime Trihydrate…..100mg
07.03.2019
ATC Code: J01DD08
Approval status of product in CEFIXIME 100 MG/5 ML POWDER FOR ORAL
Reference Regulatory Authorities SUSPENSION - PL 04569/1118; UK/H/2828/001/DC
MHRA APPROVED.
Me-too status Fixicef Powder for oral suspension Reg. No. 080273
ii. The strength of applied product is 100mg/5ml with
active 100mg/5ml as trihydrate. Correction is
required along with submission of requisite fee
(Full Fee)
viii. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
“Each 5ml Contains;
Cefixime Trihydrate equivalent to Cefixime …..100mg”
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + TRICEF 200mg Suspension.
Strength
Cefixime trihydrate ………..200mg
07.03.2019
ATC Code: J01DD08
Approval status of product in CEFIXIME 200MG/5ML FOR SUSPENSION; ORAL.
Reference Regulatory Authorities BY ALKEM LABS LTD.
USFDA APPROVED.
Me-too status Cefspan DS Suspension Reg. No. 024634
ii. The strength of applied product is 200mg/5ml with
active 200mg/5ml as trihydrate. Correction is
required along with submission of requisite fee
(Full Fee)
ix. Firm has referred to the Capacity assessment
(Cephalosporin)
(Cephalosporin)
“Each 5ml Contains;
Cefixime Trihydrate equivalent to Cefixime …….. 200mg”
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + Calcifer 5mg/1ml Injection (IM)
Strength
Cholecalciferol BP……..5mg
07.03.2019
Pharmacological Group Vitamin D and analogues
ATC Code: A11CC05
Approval status of product in VITAMIN D3 BON 200,000 IU/1 ML SOLUTION FOR
Reference Regulatory Authorities INJECTION IM AMPOULE
ANSM FRANCE APPROVED.
Me-too status Sunny D Insta Ampoule Reg. No. 063450
x. Firm has referred to the Capacity assessment
meeting of Registration Board Wherein Board
(Cephalosporin)
(Cephalosporin)
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + MEFLOX 400mg Tablet
Strength
Moxifloxacin HCl…………. 400mg
07.03.2019
ATC Code: J01MA14
Pack size & Demanded Price 5’s and 10’s. As per SRO.
Approval status of product in KIMOKS 400 MG FILM-COATED TABLETS
Reference Regulatory Authorities (MOXIFLOXACIN HYDROCHLORIDE) - PL
34088/0047; UK/H/6473/001/DC
MHRA APPROVED.
Me-too status Avelox Tablets Reg. No. 024653
M/s Bayer Pakistan Ltd Karachi.
ii. The applied strength/formulation is of combined
drug and its HCl. The label needs to be revised to
mention equivalent strength of drug as its HCl salt.
Requisite for correction is also required (Full Fee).
iii.
“Each Film Coated Tablet Contains;
Moxifloxacin as HCl…………. 400mg”
No. 7-11/2012-B&A dated 07.05.2021
Contract with
Brand Name + Dosage Form + Hb-Plus 100mg/5ml Injection (IV)
Strength
Iron Sucrose equivalent to Elemental Iron……100mg
07.03.2019
Pharmacological Group Iron, parenteral preparations
ATC Code: B03AC
Approval status of product in SUCROFER 20 MG IRON/ML, SOLUTION FOR
Reference Regulatory Authorities INJECTION /INFUSION (IRON SUCROSE) -
UK/H/6369/001/DC; PL 20568/0083
MHRA APPROVED.
Me-too status Venofer IV Injection Reg. No. 085031
M/s OBS Pakistan Karachi.
ii. Firm has referred to the Capacity assessment
meeting of Registration Board, wherein Board
decided to allow contract manufacturing from
M/s Medisave Pharmaceuticals, Plot 578-579,
Sundar Industrial Estate, Lahore for following
sections:
(Cephalosporin)
(Cephalosporin)
Decision: Deferred for evidence of availability of atomic absorption spectrophotometer as
required by the USP monograph.
425. Name and address of manufacturer/ M/s Arreta Pharmaceuticals (pvt) Ltd. Plot no. 13, Street
Applicant No. N-5, RCCI, Industrial Estate, Rawalpindi (DML No.
000846).
Brand Name + Dosage Form + COARTEM Tablet 20mg/120mg
Strength
Composition Each Tablet Contains:
Artemether……….….20mg
Lumefantrine……….120mg
20000/- vide Slip No. 0846642 dated 07.03.2019
Pharmacological Group Artemisinin and derivatives, combinations
ATC Code: P01BF01
Type of Form Form 5
Finished product Specification Innovators Specifications.
Pack size & Demanded Price 2×8’s, Rs. 240/-
Approval status of product in Artemether and Lumefantrine 20mg/120mg tablet
Reference Regulatory Authorities approved by WHO Pre-qualified product list.
Me-too status Arther Tablets 20mg/120mg Reg. No. 049292
M/s Focus & Rulz Islamabad.
GMP status
Remarks of the Evaluator i. Updated GMP status is required.
ii. Applied product is available in International
Pharmacopoeia and firm has applied
innovators specifications. Specifications shall
be changed along with submission of requisite
fee.
Decision: Approved with IP Specifications. Registration letter shall be issued after submission
of fee Rs. 7500/- as per Notification No. 7-11/2012-B&A dated 07.05.2021 and submission of
GMP inspection report/ certificate within last 3 years by QA&LT Division.
Applicant No. N-5, RCCI, Industrial Estate, Rawalpindi. (DML No.
000846).
Brand Name + Dosage Form + COARTEM FORTE Tablet 80mg/480mg
Strength
Artemether……….….80mg
Lumefantrine……….480mg
Diary No. Date of R & I & fee Dy. No. 13344 dated 07-03-2019. Fee paid Rs. 20000/-
Pharmacological Group Artemisinin and derivatives, combinations
ATC Code: P01BF01
Type of Form Form 5
Finished product Specification Innovator’s Specifications
Pack size & Demanded Price 6’s, Rs. 330/-
Approval status of product in WHO Approved formulation
Me-too status Artiavant Tablet 80/480mg Reg. No. 102981
M/s Avant Pharmaceuticals (Pvt) Ltd Balochistan
GMP status
ii. Applied product is available in International
Pharmacopoeia and firm has applied
innovators specifications. Specifications shall
be changed along with submission of requisite
fee.
Decision: Approved with IP Specifications.
Registration letter shall be issued after submission of fee Rs. 7500/- as per Notification No. 7-
11/2012-B&A dated 07.05.2021 and submission of latest GMP inspection report/ certificate
within last 3 years by QA&LT Division.
000846).
Brand Name + Dosage Form + Arrefloxacin 250mg tablet
Strength
Composition Each Film Coated Tablet contains:
Levofloxacin as hemihydrate…………250mg
20000/- vide slip No. 1900443 dated 07.03.2019.
ATC Code: J01MA12
Type of Form Form 5
Approval status of product in Ipca Laboratories UK Limited
Me-too status Brodin 250mg tablets Reg. No. 024610
M/s Werrick Pharmaceuticals.
GMP status
Remarks of the Evaluator i. Valid GMP certificate/ report is required.
Decision: Approved. Registration letter shall be issued after submission of latest GMP
inspection report/ certificate within last 3 years by QA&LT Division.
Applicant No. N-5, RCCI, Industrial Estate, Rawalpindi.
(DML No. 000846).
Brand Name + Dosage Form + Arrefon Tablet 5mg
Strength
Composition Each sugar coated tablet contains:
Bisacodyl……………….5mg
Pharmacological Group Contact laxatives
ATC Code: A06AB02
Type of Form Form 5
Finished product Specification B.P Specifications.
Pack size & Demanded Price 10×10’s
Approval status of product in Bisacodyl gastro resistant tablet 5mg
Me-too status Bisacodyl 5mg tablet of M/s SAMI (Reg. # 002981)
GMP status
ii. The product approved in RRA is gastro-
resistant formulation, whereas applied
formulation is sugar coated. Change of
formulation is required along with submission
of requisite fee.
Each gastro-resistant tablet contains:
Bisacodyl……………….5mg
000846).
Brand Name + Dosage Form + Arreval 75mg Capsule
Strength
Composition Each Extended release capsule contains:
Venlafaxine Hydrochloride pellet 33% eq. to
venlafaxine………..75mg
20000/- vide slip No. 0785044 dated 07.03.2019
Pharmacological Group ANTIDEPRESSANTS.
ATC Code: N06AX16
Type of Form Form 5
Pack size & Demanded Price 2×7’s & as per SRO
Approval status of product in Venlafaxine Hydrochloride extended release capsule
Reference Regulatory Authorities (37.5mg, 75mg, 150mg) by M/s TEVA, USFDA
Approved.
Me-too status Venflax XR 75mg capsule of M/s Regal Pharmaceuticals
GMP status Not Provided
ii. Source of pellets is required.
Decision: Approved. Registration letter shall be issued after submission of updated GMP
status within last 3 years by QA&LT Division, source of pellets and applicable fee as per
notification vide No. F.7-11/2012-B&A/DRAP dated 07.05.2021
Applicant No. N-5, RCCI, Industrial Estate, Rawalpindi.
(DML No. 000846).
Brand Name + Dosage Form + Arreval 150mg Capsule
Strength
Composition Each Extended release capsule contains:
Venlafaxine Hydrochloride pellet 33% eq. to
venlafaxine………..150mg
Pharmacological Group ANTIDEPRESSANTS.
ATC Code: N06AX16
Type of Form Form 5
Pack size & Demanded Price 2×7’s & as per SRO
Approval status of product in Venlafaxine Hydrochloride extended release capsule
Reference Regulatory Authorities (37.5mg, 75mg, 150mg) by M/s TEVA, USFDA
Approved.
Me-too status Zentel Suspension Reg. No. 006730
M/s Glaxo Smith Kline Karachi.
GMP status Not Provided
ii. Source of pellets is required.
status within last 3 years by QA&LT Division, source of pellets and applicable fee as per
notification vide No. F.7-11/2012-B&A/DRAP dated 07.05.2021
Applicant No. N-5, RCCI, Industrial Estate, Rawalpindi. . (DML No.
000846).
Brand Name + Dosage Form + Arrezole 100mg Suspension
Strength
Albendazole………….100mg
Diary No. Date of R & I & fee Dy. No. 13334; dated 07-03-2019; Fee Paid 20000/-
vide Slip No. 0846634 dated 07.03.2019.
Pharmacological Group ANTINEMATODAL AGENTS, Benzimidazole
derivatives.
ATC Code: P02CA03
Type of Form Form 5
Pack size & Demanded Price 10ml, Rs. 18.65/-
Me-too status Benda by M/s Pharmedic
GMP status Vaild GMP certificate is not provided.
ii. Section approval letter is required.
iii. Evidence of approval in RRA is required.
000846).
Brand Name + Dosage Form + B-Six Tablet 50mg
Strength
Pyridoxine Hydrochloride……….50mg
Diary No. Date of R & I & fee Dy. No. 13331; dated 07-03-2019; Fee Paid Rs.
Pharmacological Group Other plain vitamin preparations.
ATC code: A11HA02
Type of Form Form-5
Approval status of product in Pyridoxine hydrochloride 50mg tablets
Me-too status Pyro-6 Tablet Reg. No. 028861
M/s Medera Pharmaceuticals Islamabad.
GMP status
Remarks of the Evaluator i. Updated GMP Status is required.
ii. The upper tolerable limit of Vitamin B6
(pyridoxine) is 100 mg for adults.
status within last 3 years by QA&LT Division.
000846).
Brand Name + Dosage Form + Cinpro 1mg tablet
Strength
Cinitapride hydrogen tartrate eq. to cinitapride……..1mg
Diary No. Date of R & I & fee Dy. No. 13323 dated 07-03-2019; Fee Paid Rs.
20000/- vide Slip No. 0825413 dated 07.03.2019.
Pharmacological Group Gastro-prokinetic, propulsive
ATC Code: A03FA08
Type of Form Form 5
Finished product Specification Innovator’s Specifications
Pack size & Demanded Price 10’s, Rs. 175/-
Approval status of product in Cidine 1mg tablet
Reference Regulatory Authorities CIMA Spain Approved.
Me-too status Cinita Tablet Reg. No. 061706.
GMP status Valid GMP certificate is not provided.
000846).
Brand Name + Dosage Form + Arrexan Tablet 550mg
Strength
Composition Each film coated tablet contains:
Rifaximin……………550mg
Diary No. Date of R & I & fee Dy. No. 13352; dated 07-03-2019; Fee Paid
Rs.20000/- vide slip No. 0588338 dated 07.03.2019
Pharmacological Group INTESTINAL ANTIINFECTIVES, Antibiotics
ATC Code: A07AA11
Type of Form Form-5
Approval status of product in XIFAXAN Tablets by SALIX PHARMA
Reference Regulatory Authorities (USFDA Approved)
Me-too status Nixaf 550mg tablet Reg. No. 073700.
M/s Sami Pharmaceuticals Karachi
GMP status
Remarks of the Evaluator i. Updated GMP Status is required.
000846).
Brand Name + Dosage Form + Arrewarf 5mg Tablet
Strength
Warfarin Sodium……….5mg
Diary No. Date of R & I & fee Dy. No. 13414; dated 07-03-2019; Fee paid Rs.
Pharmacological Group Vitamin K antagonists
ATC Code; B01AA03
Type of Form Form 5
Finished product Specification BP Specifications
Pack size & Demanded Price 10×10’s, As per SRO
Approval status of product in Warfarin Sodium 5mg
Me-too status Warfin 5mg tablet Reg. No. 018670.
M/s Shaigan Pharmaceuticals.
GMP status
Remarks of the Evaluator Updated GMP status is required.
000846).
Brand Name + Dosage Form + Arrecast 10mg tablet
Strength
Montelukast Sodium……….10mg
Diary No. Date of R & I & fee Dy. No. 13315 dated 07-03-2019; Fee paid 20000/-
vide slip No. 0825405 dated 07.03.2019
Pharmacological Group Leukotriene receptor antagonists
ATC Code: R03DC03
Type of Form Form 5
Pack size & Demanded Price 14’s, as per SRO.
Approval status of product in Montelukast film coated 10mg
Me-too status Montiget 10mg tablet Reg. No. 034838
M/s Getz Pharmaceuticals.
GMP status
status within last 3 years by QA&LT Division and correction of salt form alongwith requisite
fee.
000846).
Brand Name + Dosage Form + Rion 2mg tablet
Strength
Risperidone…………2mg
Pharmacological Group Other antipsychotics
ATC Code: N05AX08
Type of Form Form 5
RISPERIDONE 0.5MG, 1MG, 2MG, 3MG, 4MG AND
Reference Regulatory Authorities 6MG FILM-COATED TABLETS
MHRA Approved
Me-too status Risperiscot Flash Tablet 2mg Reg. No. 046253
000846).
Brand Name + Dosage Form + Rion 4mg tablet
Strength
Risperidone…………4mg
ATC Code: N05AX08
Type of Form Form 5
RISPERIDONE 0.5MG, 1MG, 2MG, 3MG, 4MG AND
Reference Regulatory Authorities 6MG FILM-COATED TABLETS
MHRA Approved
Me-too status Risperiscot Flash Tablet 4mg Reg. No. 046255
000846).
Brand Name + Dosage Form + B-HISTINE 8mg Tablet
Strength
Betahistine dihydrochloride …. 8 mg
Pharmacological Group Antivertigo preparations.
ATC Code: N07CA01
Type of Form Form 5
Pack size & Demanded Price 3x10’s. as per SRO
Approval status of product in Betahistine Dihydrochloride 8 mg, 16 mg and 24 mg
MHRA Approved.
Me-too status Dowbet Tablet 8 mg. Reg. No. 107871
M/s Martin Dow Ltd Karachi.
GMP status
000846).
Brand Name + Dosage Form + B-HISTINE 24mg Tablet
Strength
Betahistine dihydrochloride …. 24 mg
Pharmacological Group Antivertigo preparations.
ATC Code: N07CA01
Type of Form Form 5
Pack size & Demanded Price 3x10’s. as per SRO
Approval status of product in Betahistine Dihydrochloride 8 mg, 16 mg and 24 mg
MHRA Approved.
Me-too status Dowbet Tablet 24 mg. Reg. No. 107869
M/s Martin Dow Ltd Karachi.
GMP status
000846).
Brand Name + Dosage Form + Niclosan 500mg Chewable Tablet
Strength
Composition Each Chewable Tablet Contains;
Niclosamide………. 500 mg
Pharmacological Group ANTICESTODALS, Salicylic acid derivatives.
ATC Code: P02DA01
Type of Form Form 5
Pack size & Demanded Price 4’s, As per SRO.
Me-too status Mesan Tablets Reg. No. 018668
M/s shaigan Pharmaceuticals Rawalpindi.
GMP status
ii. Evidence of approval of applied product in RRA
is required. The evidence provided is
discontinued by FDA.
000846).
Brand Name + Dosage Form + NEBILOL 2.5mg Tablet
Strength
Nebivolol …….. 2.5 mg
Pharmacological Group Beta blocking agents, selective.
ATC Code: C07AB12
Type of Form Form 5
Pack size & Demanded Price 1x14’s. As per SRO.
Approval status of product in Nebivolol 2.5 mg Tablets
Me-too status Neobiv 2.5mg Tablet Reg. No. 099198
M/s ARP (Pvt.) Ltd. Rawat.
GMP status
ii. The Nebivolol is as hydrochloride salt. The
label claim is required to be changed
fee (full fee).
iii. The innovator product is not film coated.
Justification or change is required.
Each Tablet Contains;
Nebivolol HCl equivalent to Nebivolol …….. 2.5 mg
000846).
Brand Name + Dosage Form + ALCETAZINE 5mg Tablet
Strength
Levocetirizine Dihydrochloride ……….. 5 mg
Pharmacological Group ANTIHISTAMINES FOR SYSTEMIC USE,
Piperazine derivatives.
ATC Code: R06AE09
Type of Form Form 5
Pack size & Demanded Price 3x10’s
Approval status of product in Levocetirizine Dihydrochloride 5 mg Film-coated Tablets
Me-too status T-Day Tablet 5 mg Reg. No. 083964
M/s GlaxoSmithKline Petaro Roard.
GMP status
000846).
Brand Name + Dosage Form + ARRESTAT 80mg Tablet
Strength
Febuxostat ……… 80mg
Pharmacological Group Preparations inhibiting uric acid production,
ATC Code: M04AA03.
Type of Form Form 5
Pack size & Demanded Price 3x10’s As per SRO
Approval status of product in Febuxostat 80mg, 120mg Film coated Tablets
Reference Regulatory Authorities (febuxostat hemihydrate)
MHRA Approved.
Me-too status Febast 80mg Tablets Reg. No. 087606
M/s Biolabs (Pvt) Ltd Islamabad.
GMP status
ii. The innovators product contains febuxostat as
hemihydrate. Label needs to be corrected
fee (full fee).
Each Film Coated Tablet Contains;
Febuxostat as hemihydrate……… 80mg
Registration letter shall be issued after submission of fee Rs. 30,000/- as per Notification No.
7-11/2012-B&A dated 07.05.2021 and submission of latest GMP inspection report/ certificate
000846).
Brand Name + Dosage Form + ARRETAC 150mg Tablet
Strength
Ranitidine as Hydrochloride…… 150 mg
Pharmacological Group H2-receptor antagonists.
ATC Code: A02BA02
Type of Form Form 5
Pack size & Demanded Price 10’s, as per SRO.
Approval status of product in MAR-RANITIDINE, Ranitidine Tablets, USP
Reference Regulatory Authorities 150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Health Canada Approved.
Me-too status Zantac 150mg Reg. No. 006520
M/s Glaxo Smith Kline Pakistan Karachi.
GMP status
Remarks of the Evaluator The Registration Board in its 294th meeting had decided to
suspend registration of all ranitidine containing medicinal
products, based upon the FDA decision.
Decision: Deferred till the decision by reference regulatory authorities regarding ranitidine
containing medicinal products.
000846).
Brand Name + Dosage Form + LORIN 5mg Syrup
Strength
Loratadine ……….5 mg
ATC Code: R06AX13
Type of Form Form 5
Pack size & Demanded Price 60 ml, as per SRO.
Approval status of product in Loratadine 5mg/5ml Oral Solution
Me-too status Softin Syrup Reg. No. 024780
M/s Werrick Pharmaceuticals Islamabad.
GMP status
ii. Label claim of tablet is given instead of oral
liquid. Revised label claim is required along
with requisite fee (Full fee).
iii. Section approval letter is required.
Each 5 ml Contains;
Loratadine ……….5 mg
Registration letter shall be issued after submission of fee Rs. 30,000/- as per Notification No. 7-
000846).
Brand Name + Dosage Form + OSICARE Tablet 630 mg
Strength
Activated Attapulgite…………..630mg
Pharmacological Group Other intestinal adsorbents.
ATC Code: A07BC04
Type of Form Form 5
Approval status of product in Not provided
Me-too status Not provided.
GMP status
ii. Evidence of RRA approval required.
iii. Evidence of me-too is required.
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.
000846).
Brand Name + Dosage Form + ROVASTATIN 5mg Tablet
Strength
Rosuvastatin Calcium equivalent to
Rosuvastatin……………………..5mg.
ATC Code: C10AA07
Type of Form Form 5
Approval status of product in Ropuido 5 mg film-coated tablets.
Me-too status Rovista Tablet 5mg, Reg. No. 044043
GMP status
000846).
Brand Name + Dosage Form + ROVASTATIN 20mg Tablet
Strength
Rosuvastatin Calcium equivalent to
Rosuvastatin……………………..20mg.
ATC Code: C10AA07
Type of Form Form 5
Approval status of product in Rosuvastatin 20 mg film-coated tablets.
Me-too status Rovista Tablet 20mg, Reg. No. 044045
GMP status
450. Name and address of manufacturer/ M/s Aries Pharmaceuticals (Pvt) Ltd, 1-W, Industrial
Applicant Estate, Hayatabad, Peshawar. (DML 000565).
Brand Name + Dosage Form + Co-Locor tablet 100mg/25mg
Strength
Losartan Potassium……100mg
Hydrochlorthiazide………25mg
Pharmacological Group Angiotensin II antagonist & Diuretics
ATC Code: C09DA01
Type of Form Form 5
Approval status of product in Cozaar Comp 100 mg/25 mg film-coated tablets
Me-too status Co-Eziday tablet Reg. No. 056104
M/s Werrick Pharmaceuticals.
GMP status Last panel inspection conducted on 03.12.2021. GMP
status is good.
Decision: Approved.
Applicant Estate, Hayatabad, Peshawar. (DML No. 00565)
Oral Liquid (General) Section.
Brand Name + Dosage Form + Arilac Syrup
Strength
Lactulose……..3.335g
Diary No. Date of R & I & fee Dy. No. 14354; dated 07-03-2019; fee paid Rs.
20000/- vide slip no. 0829854 dated 04.03.2019
Pharmacological Group Osmotically acting laxatives.
ATC Code: A06AD11
Type of Form Form 5
Approval status of product in Lactulose 3.3g/5ml Oral Solution
Me-too status Duphalac Syrup Reg. No. 006655
M/s Abbott Laboratories
status is good.
Decision: Approved. Firm shall submit documents for source of Lactulose along with GMP
certificate, COA, stability studies of three batches & differential fee (in case of import).
.
Brand Name + Dosage Form + Isotor Capsule 10mg
Strength
Composition Each capsule contains:
Isotretnoin……10mg
20000/- Vide Slip No. 0829871 dated 04.03.2019.
Endorsed on 06.03.2019.
Pharmacological Group Retinoids for treatment of acne
ATC Code: D10BA01
Type of Form Form 5
Approval status of product in Absorica (isotretinoin) Capsules, 10 mg, 20 mg, 30 mg,
Reference Regulatory Authorities and 40 mg
USFDA Approved.
Me-too status Isonex capsule 10mg Reg. No. 060799
M/s Shrooq Pharma
status is good.
Decision: Deferred for submission of stability studies data as per checklist of 293rd meeting
of DRB, in light of the Notifdication No. 320-DRB/ 2022(PE&R) dated 17th October
2022.
Brand Name + Dosage Form + Isotor Capsule 20mg
Strength
Isotretnoin……20mg
20000/- Vide Slip No. 0829883 dated 04.03.2019.
Endorsed on 06.03.2019.
Pharmacological Group Retinoids for treatment of acne
ATC Code: D10BA01
Type of Form Form 5
Approval status of product in Absorica (isotretinoin) Capsules, 10 mg, 20 mg, 30 mg,
Reference Regulatory Authorities and 40 mg
USFDA Approved.
Me-too status Isonex capsule 20mg Reg. No. 060798
M/s Shrooq Pharma
status is good.
Decision: Deferred for submission of stability studies data as per checklist of 293rd meeting
of DRB, in light of the Notifdication No. 320-DRB/ 2022(PE&R) dated 17th October
2022.
Brand Name + Dosage Form + Averon tablet 24mg
Strength
Ondansetron Hydrochloride Dihydrate eq. to Ondansetron
………. 24mg
Pharmacological Group Antiemetic (5-HT3 receptor antagonist)
ATC Code: A04AA01
Type of Form Form 5
Approval status of product in Could not be verified for 24 mg strength.
Me-too status Could not be verified for 24 mg strength.
status is good.
Remarks of the Evaluator i. The evidence of RRA approval (Zofran
24mg) is discontinued. Valid evidence of
RRA approval is required.
ii. Evidence of me-too product is required
having strength of 24mg.
which were declared/approved by the Registration Board
Brand Name + Dosage Form + Aricort Tablet 5mg
Strength
Prednisolone………5mg
Diary No. Date of R & I & fee Dy. No. 14405; dated 7-03-2019; Fee Paid Rs. 20000/-
vide Slip no. 0832347 dated 06.03.2019 endorsed on
07.03.2019
Pharmacological Group CORTICOSTEROIDS FOR SYSTEMIC USE,
PLAIN, Glucocorticoids.
ATC Code: H02AB06
Type of Form Form 5
Approval status of product in Prednisolone 5mg Tablets BP
Me-too status Deltacortril 5mg tablet Reg. No. 000448
status is good.
Decision: Registration Board rejected the application since firm does not have approved
manufacturing facility for “Tablet (Steroid)” section.
Tablet Section (Hormone/General)
Brand Name + Dosage Form + REGEN Tablet 1mg
Strength
Composition Each Film coated tablet contains:
Finasteride………..1mg
Diary No. Date of R & I & fee Dy. No. 14362 dated 07-03-2019; Fee paid Rs.
20000/- vide Slip No. 0829862
Pharmacological Group Testosterone-5-alpha reductase inhibitor
ATC Code: G04CB01
Type of Form Form 5
Approval status of product in Finsteride1mg Film-Coated tablet.
Me-too status Finarid-M Tablet Reg. No. 078402
M/s Shaheen Pharmaceuticals
status is good.
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Brand Name + Dosage Form + Andro Tablet 150mg
Strength
Ibandronate Sodium Monohydrate eq. to Ibandronic
acid……………150mg
20000/- vide Slip No.0829852 dated 04.03.2019
Pharmacological Group Bisphosphonate agent
ATC Code: M05BA06
Type of Form Form 5
Finished product Specification Aries’ specifications
Approval status of product in Ibandronic Acid 150mg Film-coated Tablets
Me-too status Bonheal tablets 150mg Reg. No. 069250
M/s Novamed Pharmaceuticals Lahore.
status is good.
Decision: Approved.
Brand Name + Dosage Form + MESTANE Tablet 25mg
Strength
Exemestane……………25mg
20000/- vide Slip No.0829901 dated 06.03.2019
Pharmacological Group Aromatase inhibitors.
ATC Code: L02BG06
Type of Form Form 5
Finished product Specification Aries’ specifications
Approval status of product in Exemestane 25 mg film-coated tablets
Me-too status Aromasin Tablet 25mg Reg. No. 028359
status is good.
correction/pre-approval change in product specifications as per notification No.F.7-11/2012-
Registration Board approved registration of product in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
Brand Name + Dosage Form + IBUDEX Tablet 400mg
Strength
Dexibuprofen……….. 400mg
PRODUCTS, NON-STEROIDS, Propionic acid
derivatives
ATC Code: M01AE14
Type of Form Form 5
Finished product Specification Aries’ Specifications.
Approval status of product in Dexibuprofen 400 mg Film-coated Tablets
Me-too status Tercica 400mg Tablet Reg. No. 058446
M/s Sami Pharmaceuticals Karachi.
status is good.
Brand Name + Dosage Form + BESART Tablet 150mg
Strength
Irbesartan USP…………..150mg
ATC Code: C09CA04
Type of Form Form 5
Approval status of product in Irbesartan 75 mg, 150 mg and 300 mg film-coated
MHRA Approved.
Me-too status Irecon Tablet 150mg Reg. No. 039726
M/s Barrett Hodgson Pakistan Karachi.
status is good.
Decision: Approved.
Brand Name + Dosage Form + BESART Tablet 300mg
Strength
Irbesartan USP…………..300mg
ATC Code: C09CA04
Type of Form Form 5
Approval status of product in Irbesartan 75 mg, 150 mg and 300 mg film-coated
MHRA Approved.
Me-too status Irecon Tablet 300mg Reg. No. 039727
M/s Barrett Hodgson Pakistan Karachi.
status is good.
Decision: Approved.
Tablet Section (Hormone)
Brand Name + Dosage Form + ESTRA Tablet 2.0mg
Strength
Estradiol Valerate………..2.0mg
Pharmacological Group Natural and semisynthetic estrogens, plain.
ATC Code: G03CA03
Type of Form Form 5
Approval status of product in PROGYNOVA 2 mg, coated tablet.
Reference Regulatory Authorities ANSM France Approved.
Me-too status Progynova Tablet Reg. No. 017864
M/s Bayer Pak (Pvt) Ltd Karachi.
status is good.
Remarks of the Evaluator The RRA product is a coated tablet, applied product is
uncoated. Justification or correction is required along with
Decision: Approved with Inovator’s specifications as per following label claim:
“Each film coated tablet Contains;
Estradiol Valerate……….2.0mg”
Registration letter shall be issued after submission of correct formulation, label and fee
of Rs. 7500/- for revision from uncoated tablet to film coated tablet.
Brand Name + Dosage Form + BAMRAL Tablet 10mg
Strength
Bambuterol HCl……………..10mg
Pharmacological Group Selective beta-2-adrenoreceptor agonists.
ATC Code: R03CC12
Type of Form Form 5
Approval status of product in BAMBEC® 10 mg Tablets
Me-too status Bambec Tablet 10mg Reg. No. 017321
M/s Barret Hodgson Pakistan (Pvt)(Ltd) Karachi
status is good.
Decision: Approved with Inovator’s specifications. The firm shall submit fee of Rs. 7500/- for
Brand Name + Dosage Form + PROX CR Tablet 12.5mg
Strength
Composition Each Enteric Coated Controlled Release Tablet Contains;
Paroxetine HCl USP eq. to Paroxetine …12.5mg
Pharmacological Group Selective serotonin reuptake inhibitors.
ATC Code: N06AB05
Type of Form Form 5
Approval status of product in PAXIL CR 12.5mg, 25mg, 37.5mg
Me-too status Pariz Tablets 12.5mg Reg. No. 052593
status is good.
Decision: Approved.
Brand Name + Dosage Form + CO-BESART Tablet 150mg/12.5mg
Strength
Irbesartan USP……………..150mg
Hydrochlorothiazide USP….12.5mg
Pharmacological Group Angiotensin II receptor blockers (ARBs) and
diuretics.
C09DA04
Type of Form Form 5
Approval status of product in AVALIDE® (irbesartan and hydrochlorothiazide)
Reference Regulatory Authorities 150/12.5 mg and 300/12.5 mg film-coated
Tablets
USFDA Approved.
Me-too status Irecon-H Tablet Reg. No. 042272
M/s Barrett Hodgson Pakistan (Pvt) Ltd Karachi.
status is good.
Decision: Approved.
Tablet Section (Hormone)
Brand Name + Dosage Form + NOPROST Vaginal tablet 3mg
Strength
Dinoprostone USP ………….. 3.0mg
Pharmacological Group UTEROTONICS, Prostaglandins.
ATC code: G02AD02
Type of Form Form 5
Finished product Specification Manufacturer’s Specifications.
Me-too status Ditone E2 Vaginal Tablet Reg. No. 084376
M/s Shaigan Pharmaceutical Rawalpindi.
status is good.
Remarks of the Evaluator The RRA reference could not be verified. Evidence of
applied product in RRA is required.
Brand Name + Dosage Form + AVERON Syrup 4.0mg
Strength
Ondansetron Hydrochloride dehydrate eq. to Ondansetron
….4.0mg
Pharmacological Group ANTIEMETICS AND ANTINAUSEANTS,
Serotonin (5HT3) antagonists.
ATC Code: A04AA01
Type of Form Form 5
Approval status of product in ZOFRANEQ 4MG BASE/5MLSOLUTION; ORAL
Me-too status Dantron Oral Solution Reg. No. 077076
M/s Shrooq Pharmaceuiticals (Pvt) Ltd Lahore.
status is good.
Decision: Approved.
Liquid Ampoule Injection Section (General)
Brand Name + Dosage Form + RANITIN INJECTION 50mg/2ml
Strength
Ranitidine HCl eq. Ranitidine … 50mg
Pharmacological Group H2-receptor antagonists.
ATC Code: A02BA02
Type of Form Form 5
Approval status of product in Ranitidine 50 mg/2 ml Solution for injection or infusion
Me-too status Ranulcid Injection Reg. No. 025487
M/s martin Dow Marker
status is good.
Remarks of the Evaluator The Registration Board in its 294th meeting had decided to
suspend registration of all ranitidine containing medicinal
products, based upon the FDA decision.
Brand Name + Dosage Form + FUMIDE INJECTION 20mg/2ml (IV/IM)
Strength
Furosemide USP……20mg
Diary No. Date of R & I & fee Dy. No. 14383; dated 07-03-03-2019; Fee paid Rs.
Pharmacological Group HIGH-CEILING DIURETICS, Sulfonamides, plain.
ATC Code: C03CA01
Type of Form Form 5
Approval status of product in Furosemide 20mg/2ml Solution for Injection.
Me-too status Lasix Injection 20mg Reg. No. 000230
status is good.
Decision: Approved.
Brand Name + Dosage Form + CARDIN INJECTION 0.5mg/2ml (IV)
Strength
Digoxin USP .0.5mg
Pharmacological Group Digitalis glycosides
ATC Code: C01AA05
Type of Form Form 5
Approval status of product in Digoxin 250 micrograms/ml Solution for Injection
Me-too status Lanoxin Injection 2 ml Reg. No. 001608
M/s Getz Pharma (Pvt) Ltd Karachi.
status is good.
Decision: Approved.
Brand Name + Dosage Form + BUVAC Injection 5mg/1ml
Strength
Bupivacaine HCl USP…….5mg
Pharmacological Group ANESTHETICS, LOCAL, Amides
ATC Code: N01BB01
Type of Form Form 5
Approval status of product in Could not be confirmed for 1ml Ampoule
Me-too status Bucane 5mg/ml Injection Reg. No. 045495
M/s Ophth-Pharma (Pvt) Ltd. Karachi.
status is good.
Remarks of the Evaluator Evidence of product in RRA provided is discontinued.
Proper Evidence in RRA is required for Bupivacaine HCl
5mg/1ml in 1ml ampoule.
Brand Name + Dosage Form + DROTIC INJECTION 40mg/2ml
Strength
Drotaverine HCl…40mg
Pharmacological Group DRUGS FOR FUNCTIONAL
GASTROINTESTINAL DISORDERS, Papaverine
and derivatives.
ATC Code: A03AD02
Type of Form Form 5
Approval status of product in Three European countries Bulgaria, Latvia, Hungary.
Me-too status I-Spa 40mg/2ml Injection Reg. No. 097722
M/s Iqra Pharmaceuticals Islamabad.
status is good.
Decision: Approved with Inovator’s specifications. The firm shall submit fee of Rs. 7500/- for
Brand Name + Dosage Form + NARLOX INJECTION 0.4mg/1ml(IV/IM/SC)
Strength
Naloxone HCl….0.4mg
Pharmacological Group Antidotes
ATC Code: V03AB15
Type of Form Form 5
Approval status of product in Naloxone Hydrochloride 400mcg/ml Solution for
Reference Regulatory Authorities injection
MHRA Approved.
Me-too status NXN 0.4mg/ml Injection Reg. No. 107312
M/s Rotex Pharma Islamabad.
status is good.
Decision: Approved.
Brand Name + Dosage Form + EPIVON INJECTION 500mg/5ml (IV)
Strength
Valproate Sodium Eq. to Valproic Acid USP ..500mg
Pharmacological Group ANTIEPILEPTICS, Fatty acid derivatives,
ATC Code: N03AG01
Type of Form Form 5
Approval status of product in Couldn’t be verified for applied product.
Me-too status Epival IV Injection Reg. No. 023349
M/s Abbott Laboratories Karachi.
status is good.
Remarks of the Evaluator The Evidence of RRA provided (Depacon USFDA) is
discontinued. Evidence of product in other RRA is
observed to be of 3ml, 4ml and 10ml. Justification, or
revision along with requisite fee is required (Full Fee).
Decision: Approved as same strength in same volume is approved by USFDA in vial form.
475. Name and address of manufacturer/ M/s Akson Pharmaceuticals (pvt.) Ltd. Plot no. 9-B/1&2,
Applicant Sector D-1, Old industrial Estate, Mirpur, Azad Kashmir.
(DML No. 000486)
Brand Name + Dosage Form + Ulcef-1 Suspension 1gm/5ml
Strength
Sucralfate USP ……… 1g
20000/-
Pharmacological Group Other drugs for peptic ulcer and gastro-oesophageal reflux
disease (GORD),
ATC Code:A02BX02
Type of Form Form 5
Pack size & Demanded Price 60ml, 90ml, 120ml, As per SRO
Approval status of product in Antepsin 1g/5ml oral suspension
Me-too status Acenil Suspension 1gm Reg. No. 069033
M/s Medisave Pharmaceuticals Lahore.
GMP status Last inspection conducted on 22.02.2019.
Remarks of the Evaluator i.Copy of section approval letter is required.
ii.Copy of latest GMP inspection
report/certificate is required.
iii. Finished product specifications are claimed to
be USP Specifications. USP Monograph of the
product is required. The firm was
communicated deficiencies and firm has
stated that USP specs are a clerical mistake
and these should be changed to Innovator’s
Specs. The firm has not submitted the
requisite fee.
Decision: Approved with Innovator’ s specifications. Registration letter shall be issued after
submission of Latest GMP inspection report conducted within last three years along with fee
of Rs. 7500/- for correction/pre-approval change in product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
(DML No. 000486)
Brand Name + Dosage Form + Ulcef-1 Tablet 1gm
Strength
Composition Each Film Coated Tablet Contains:
Sucralfate USP………1g
20000/-
Pharmacological Group Other drugs for peptic ulcer and gastro-oesophageal reflux
disease (GORD),
ATC Code:A02BX02
Type of Form Form 5
Pack size & Demanded Price 10’s, As per SRO
Approval status of product in Sucralfate Tablets USP 1gram
Me-too status Sucrafate Tablet Reg. No. 010290
M/s Abbott Laboratories Karachi.
Remarks of the Evaluator i. Copy of section approval letter is required.
ii. Copy of latest GMP inspection
Decision: Approved. Firm shall submit latest GMP inspection report conducted within last
three years before issuance of registration letter.
(DML No. 000486)
Tablet Section (Psychotropic)
Brand Name + Dosage Form + Zepra-0.25 Tablets 0.25mg
Strength
Alprazolam USP ………..0.25mg
Diary No. Date of R & I & fee Dy. No. 13308; dated 07-03-2019; Fee Paid Rs.
20000/-
Pharmacological Group ANXIOLYTICS,Benzodiazepine derivatives.
ATC Code: 05BA12
Type of Form Form-5
Approval status of product in Xanax 250 microgram Tablets
Me-too status Xanax 0.25mg Tablet Reg. No. 014417
manufacturing facility of “Tablet (psychotropic) section”.
(DML No. 000486)
Brand Name + Dosage Form + Zepra-0.5 Tablets 0.5mg
Strength
Alprazolam USP……………..0.5mg
20000/-
ATC Code: 05BA12
Type of Form Form-5
Approval status of product in Xanax 500 microgram Tablets
Me-too status Xanax 0.5mg Tablet Reg. No. 012303
manufacturing facility for “psychotropic” products.
(DML No. 000486)
Brand Name + Dosage Form + Zepra-1 Tablets 1 mg
Strength
Alprazolam……………..1mg
Diary No. Date of R & I & fee Dy. No. 13310dated 07-03-2019; Fee Paid Rs. 20000/-
ATC Code: 05BA12
Type of Form Form-5
Approval status of product in XANAX (alprazolam)Tablets: 0.25 mg, 0.5 mg, 1 mg, and
Reference Regulatory Authorities 2 mg
USFDA Approved.
Me-too status Xanax 1mg Tablet Reg. No. 013349
(DML No. 000486)
Brand Name + Dosage Form + ALZI 10mg tablet
Strength
Memantine HCl…………10mg
Diary No. Date of R & I & fee Dy No. 13296 dated 07-03-2019; Fee Paid 20000/-
Pharmacological Group Other anti-dementia drugs
ATC Code: N06DX01
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s. As per SRO
Approval status of product in Memamentine Hydrochloride 10mg and 20 mg Film-
Reference Regulatory Authorities Coated tablets
MHRA Approved.
Me-too status Afdol 10mg Tablets Reg. No. 044429
M/s AGP Pvt, Ltd. Karachi.
Remarks of the Evaluator i.
Copy of section approval letter is required.
ii.
Copy of latest GMP inspection
certificate/ inspection report conducted within last 3 years by QA&LT Division.
(DML No. 000486)
Brand Name + Dosage Form + ALZI 20mg tablet
Strength
Memantine HCl…………20mg
Diary No. Date of R & I & fee Dy No. 13297 dated 07-03-2019; Fee Paid 20000/-
ATC Code: N06DX01
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s. As per SRO
Approval status of product in Memamentine Hydrochloride 10mg and 20 mg Film-
Reference Regulatory Authorities Coated tablets
MHRA Approved.
Me-too status Memxio 20mg Tablets Reg. No. 110930
M/s AGP Pvt, Ltd. Karachi.
GMP status Inspection report dated 22.02.2019 is submitted.
ii.
(DML No. 000486)
Brand Name + Dosage Form + Denzi-4 tablet 4mg
Strength
Ondansetron (as HCl dehydrate) BP……..4mg
Diary No. Date of R & I & fee Dy. No. 13303 dated 07-03-2019. Fee paid 20000/-
ATC Code: A04AA01
Type of Form Form 5
Approval status of product in Ondansetron 4 mg & 8 mg (Ondansetron Hydrochloride
Reference Regulatory Authorities dehydrate)
MHRA Approved.
Me-too status Zofran Tablets 4 mg Reg. No. 020667
M/s GSK Karachi.
ii.
(DML No. 000486)
Brand Name + Dosage Form + Denzi-8 tablet 8mg
Strength
Ondansetron as HCl dehydrate BP……..8mg
Diary No. Date of R & I & fee Dy. No. 13302 dated 07-03-2019. Fee Paid Rs.
20000/-
ATC Code: A04AA01
Type of Form Form 5
Approval status of product in Ondansetron 4 mg & 8 mg (Ondansetron Hydrochloride
Reference Regulatory Authorities dehydrate)
MHRA Approved.
Me-too status Zofran Tablets 8 mg Reg. No. 020668
M/s GSK Karachi.
ii.
(DML No. 000486)
Brand Name + Dosage Form + Lora-5 tablet 5mg
Strength
Desloratadine………….5mg
Diary No. Date of R & I & fee Dy. No. 13298; 07-03-2019; 20000/-
ATC Code: R06AX27
Type of Form Form 5
Approval status of product in Desloratadine 5mg Film-Coated Tablets
Me-too status Alenor Reditab 5mg Tablet Reg. No. 067054
M/s Macter International (Pvt.) Ltd.
ii.
(DML No. 000486)
Tablet Section (psychotropic)
Brand Name + Dosage Form + Zepam-0.5 tablets 0.5mg
Strength
Clonazepam BP…………..0.5mg
20000/-
Pharmacological Group ANTIEPILEPTICS, Benzodiazepine derivatives.
ATC Code: N03AE01
Type of Form Form 5
Approval status of product in Clonazepam Neuraxpharm 0.5mg, 1mg and 2 mg Tablets
Me-too status RIVOTRIL TABLET 0.5mg Reg. No. 001049
M/s Martin Dow Ltd., Plot No. 37 Sector 19 Korangi
Industrial Area Karachi.
(DML No. 000486)
Brand Name + Dosage Form + Zepam-1 tablet 1mg
Strength
Clonazepam BP……………….1mg
Diary No. Date of R & I & fee Dy. No.13312 dated 07-03-2019. Fee paid Rs. 20000/-
ATC Code: N03AE01
Type of Form Form 5
Me-too status Curo 1mg Tablet Reg. No. 065700
M/s Wilshire Laboratories Lahore.
(DML No. 000486)
Brand Name + Dosage Form + Zepam-2 tablet 2mg
Strength
Clonazepam……………….2mg
Diary No. Date of R & I & fee Dy. No. 13313 dated 07-03-2019; Fee Paid Rs.
20000/-
ATC Code: N03AE01
Type of Form Form 5
Me-too status RIVOTRIL TABLET 2mg Reg. No. 003626
M/s Martin Dow Ltd., Plot No. 37 Sector 19 Korangi
Industrial Area Karachi.
(DML No. 000486)
Brand Name + Dosage Form + Monti-10 tablet 10mg
Strength
Composition Each Film Coated Tablet contains:
Montelukast(as sodium salt) BP…….10mg
Diary No. Date of R & I & fee Dy. No. 13299 dated 07-03-2019 Fee Paid 20000/-
Pharmacological Group Leukotriene receptor antagonists.
ATC Code: R03DC03
Type of Form Form 5
Approval status of product in Montelukast 10mg Film-Coated Tablets
Me-too status Singulair 10mg Tablet Reg. No. 025259
M/s.OBS Healthcare (Pvt) Ltd Karachi.
report/certificate is required
(DML No. 000486)
Brand Name + Dosage Form + Monti-4 Chewable tablet 4mg
Strength
Composition Each chewable tablet contains:
ATC Code: R03DC03
Type of Form Form 5
Pack size & Demanded Price 1×14’s, As per SRO.
Approval status of product in Montelukast 4mg Chewable Tablets
Me-too status Montelex 4mg Chewable Tablet Reg. 054328
M/s Caylex Pharmceuticals Lahore..
(DML No. 000486)
Brand Name + Dosage Form + Monti-5 Chewable tablet 5mg
Strength
Composition Each chewable tablet contains:
ATC Code: R03DC03
Type of Form Form 5
Pack size & Demanded Price 1×14’s, AS per SRO
Approval status of product in Montelukast 5mg Chewable Tablets
Me-too status Montaza Chewable Tab 5mg Reg. 048754
M/s Zafa Pharmaceutical Lab Karachi.
(DML No. 000486)
Brand Name + Dosage Form + Gasto-50 tablet 50mg
Strength
Itopride hydrochloride……………….50mg
20000/-
Pharmacological Group Propulsives
ATC Code: A03FA07
Type of Form Form 5
Finished product Specification Akson’s Specifications.
Pack size & Demanded Price 10’s, 20’s, 30’s, AS per SRO
Approval status of product in Ganaton Tablets 50mg (Film Coated)
Reference Regulatory Authorities PMDA Japan Approved.
Me-too status Inviton 50mg Tablets Reg. No. 096543
M/s Invictus Pharma Rawat.
(DML No. 000486)
Injectable Ampoule and Infusion Section (General)
Brand Name + Dosage Form + Denzi-4 Injection 4mg/2ml
Strength
Composition Each 2ml Ampoule contains:
Diary No. Date of R & I & fee Dy. No. 13305 dated 07-03-2019. Fee Paid 20000/-
ATC Code: A04AA01
Type of Form Form 5
Pack size & Demanded Price 4ml, as per SRO.
Approval status of product in Ondansetron 2mg/ml Solution for Injection/Infusion -
Reference Regulatory Authorities UK/H/3802/001/DC; PL 00057/0915
MHRA Approved.
Me-too status Welstro Injection 4mg/2ml Reg. No. 075397
M/s Welwink Gujranwala.
Remarks of the Evaluator Copy of latest GMP inspection report/certificate is
required.
(DML No. 000486)
Brand Name + Dosage Form + Denzi-8 Injection 8mg/4ml
Strength
Composition Each 4ml Ampoule contains:
Diary No. Date of R & I & fee Dy. No. 13304 dated 07-03-2019. Fee Paid 20000/-
ATC Code: A04AA01
Type of Form Form 5
Pack size & Demanded Price 4ml, as per SRO.
Approval status of product in Ondansetron 4mg/2ml Injection (4ml Ampoules)
Me-too status Ondansetron 8mg/4mlInjection Reg. No. 110920
M/s Bajwa Pharmaceuticals Sheikhupura.
ii.
Item No. XV: Agenda of Evaluator PEC-XVII.
Export Facilitation cases:

The following applications were received vide letter No.F.1-6/2019-PR-I (EFD) dated 06th October, 2022 from
Assistant Director (PR-I/EFD), PE & R, Division for evaluation on priority basis in pursuance of decision in
133rd meeting of DRAP Authority held on 13th April 2022, regarding export facilitation (Grant of registration
on priority basis to the pharmaceutical i.e one molecule for each 100,000 USD worth of export of medicines
(to a maximum of 15 such molecules) during a fiscal year).
Case No. 1: Registration Applications requiring submission of stability data:
494. Name and address of manufacturer / Applicant M/s CCL Pharmaceuticals (Pvt.) Ltd. 62-Industrial
Estate, Kot Lakhpat, Lahore.
Brand Name +Dosage Form + Strength JARDY-MET XR 5mg/1000mg Tablet
Empagliflozin……….5mg
Metformin HCl extended release…….1000mg
Diary No. Date of R& I & fee Dy. No. 6520 dated 14-02-2019, Fee Rs: 50,000/-
dated 23-11-2018 vide deposit slip No.0809686.
Pharmacological Group Antidiabetic (Sodium/glucose co transporter 2
(SGLT2) inhibitor and biguanide class)
Type of Form Form 5D
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, (4×7’s); As per SRO
Approval status of product in Synjardy XR 5/1000mg film coated tablets
Reference Regulator Authorities (USFDA Approved)
Me-too status NA
GMP status DML renewal inspection conducted on 21-10-2020,
wherein panel recommends the renewal of Drug
Manufacturing License to M/s CCL Pharmaceuticals
(Pvt) Ltd., by way of formulation to the following
sections only
Liquid Injectable Section (General)
Dry powder suspension
Capsule Section (Steroid)
Oral liquid section
Remarks of the Evaluator (PEC-XVII) Tablet (General) Section (Revised) approval granted
vide Licensing Division, letter No.F.1-8/84-Lic (Vol-
III) dated 22-06-2018.
STABILITY STUDY DATA
Manufacturer of API (Empagliflozin) M/s Fuxin Long Rui Pharmaceutical Co., Ltd. Fluoride
Industrial Park, Fumeng Country (Yi Ma Tu), Fuxing City, Liaoning
Province, China.
(Metformin hydrochloride) M/s Wanbury limited, Doctors Organic
Chemicals Division, K. Illindalaparru – 534217, Iragavaram Manadal, West
Godavari District, Andra Pradesh, India.
API Lot No. Empagliflozin: L-E-20200409-D01-E06-01)
Metformin Hydrochloride: MT01130220l
Description of Pack Alu-Alu blister packed in uni carton

(Container closure system)
Stability Storage Condition Real time: 30°C ± 2° C / 65% ± 5% RH
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (months)
Real Time: 0, 3, 6 (months)
Batch No. JMXA-T2-20 JMXA-T3-20 JMXA-T4-20
Batch Size 1000 tablets 1000 tablets 1000 tablets
Manufacturing Date 08-2020 08-2020 08-2020
Date of Initiation 31-08-2020 31-08-2020 31-08-2020
No. of Batches 03
Date of Submission 09-06-2021 (16007)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents to Be Provided Status
1. Reference of previous approval of applications The firm has referred to previous inspection for
with stability study data of the firm authenticity of stability data of their products
conducted by the panel, on the basis of which
Registration Board in its 297th meeting dated 12-
15th January, 2021, decided to approve
registration of Brivatam Tablets 10mg, Brivatam
Tablets 25mg, Brivatam Tablets 50mg, Brivatam
Tablets 75mg and Brivatam Tablets 100mg.
Inspection date: 14-10-2020.
The report shows that:
 Finished Pharmaceutical Product stability
testing was conducted on HPLC R&D # 19 for
Brivatam Tablets 10mg, Brivatam Tablets
25mg, Brivatam Tablets 50mg, Brivatam
Tablets 75mg and Brivatam Tablets 100mg
which were not 21 CFR compliant for initial 6
months.
studies conducted from 9 months onward was
on 21 CFR compliant. HPLC. Q.C .NO 122.
 Adequate monitoring and control were
available for stability chamber.
2. Certificate of Analysis of API from both API 1. Copies of COAs (Batch#L-E-20200409-D01-
Manufacturer and Finished Product E06-01) of API (Empagliflozin) from M/s
manufacturer. Fuxin Long Rui Pharmaceutical Co., Ltd.
Liaoning Province, China and M/s CCL
pharmaceuticals (Pvt) Ltd. Lahore are
submitted.
2. Copies of COAs (Batch#MT01130220) of
API (Metformin hydrochloride) from M/s
Wanbury limited, Andra Pradesh India and
M/s CCL pharmaceuticals (Pvt) Ltd. Lahore
are submitted.
3. Method used for analysis of API from both API Methods used for analysis of APIs from both API
Manufacturer and Finished Product Manufacturers and Finished Product
Manufacturer Manufacturer are provided by the firm.
4. Stability study data of API from API Empagliflozin: Firm has submitted stability study
manufacturer data of API as per zone IV-A. Stability study is
conducted at Real time conditions; 30°C ± 2°C /
65% ± 5%RH for 24 months and at Accelerated
conditions; 40°C ± 2°C / 75% ± 5%RH for 6
months at intervals 0, 3, 6, 9, 12, 18, 24 & 0, 1, 2,
3 & 6 months respectively.
Batches:(20160606,20161017,20161219)
10 days stress stability study at conditions 60°C ±
2°C, Photolysis 4500 ± 500LX and 92.5%±
5%RH at 0, 5th & 10th days intervals also
provided.
Metformin hydrochloride: Firm has submitted
stability study data of API as per zone IV-A.
Stability study is conducted at Real time
months and at Accelerated conditions; 40°C ± 2°C
/ 75% ± 5%RH for 6 months at intervals 0, 3, 6,
9, 12, 18, 24, 36, 48, 60 & 0, 1, 2, 3 & 6 months
respectively.
Batches:(MET-E-06640908, MET-E-06650908,
MET-E-06660908)
5. Approval of API/ DML/GMP certificate of API For Empagliflozin: Firm has submitted copy of
manufacturer issued by concerned regulatory GMP certificate dated 24-08-2020 in the name of
authority of country of origin. M/s Fuxin Long Rui Pharmaceutical Co., Ltd.
Fluoride Industrial Park, Fumeng Country (Yi Ma
Tu), Fuxing City, Liaoning Province, China
issued by Liaoning Fuxin Management
committee, Fluoride Industrial Development
Zone. Valid till 23-08-2023.
For Metformin hydrochloride: The firm has
submitted copy of GMP certificate of M/s
Wanbury limited, Doctors Organic Chemicals
Division, K. Illindalaparru – 534217, Iragavaram
Manadal, West Godavari District, Andra Pradesh,
India issued on dated 06-02-2019 by Drugs
Control Administration, Andra Pradesh India
valid for three (03) years from the date of issue.
6. Documents for the procurement of API with For Empagliflozin: The firm has submitted copy
approval from DRAP (in case of import). of invoice No. HN20060302-H dated 03-06-2020
from exporter M/s Beijing Sino Hanson Import &
Export Col, Ltd. No.3, Zhonghe road, Fengtai
District, Beijing China, for import of 10kgs of
Empagliflozin (Batch No. L-E-20200409-D01-
E06-01) in name of M/s CCL Pharmaceuticals
Private Ltd. Lahore attested by AD (I&E) DRAP
Lahore dated 18-06-2020.
submitted copy of invoice No. 92003089 dated
29-02-2020 from Wanbury Limited, BSEL
Techpark, 'B' Wing, 10th Floor, Sector 30-A,
Opp. Vashi Railway Station, Vashi, Navi
Mumbai – 400703, India for import of 8000kgs
Metformin HCl (1280Kgs,Batch No.
MT01130220 used in instant trial batches) in the
name of CCL Pharmaceuticals, Lahore attested
by AD (I & E) DRAP, Lahore dated 05-03-2020.
7. Protocols followed for conduction of stability Submitted
study
8. Method used for analysis of FPP Submitted
9. Drug-excipients compatibility studies (where Drug excipients compatibility study performed.

applicable)
10. Complete batch manufacturing record of three The firm has submitted Batch Manufacturing
stability batches. record of following 03 Batches:
Batch No. Batch Size Mfg. Date
JMXA-T2-20 1000 tablets 08-2020

JMXA-T3-20 1000 tablets 08-2020
JMXA-T4-20 1000 tablets 08-2020
11. Record of comparative dissolution data (where Provided

applicable) Comparative dissolution was performed against
Synjardy XR tablet (5/1000mg) Batch No.
3183238 & Synjardy XR tablet (25/1000mg),
Batch No. 3167491 in HCl buffer (pH 1.2),
Acetate buffer (pH 4.5) & Phosphate buffer (pH
6.8)
12. Data of 03 batches will be supported by attested Submitted
respective documents like chromatograms, Raw
data sheets, COA, summary data sheets etc.
13. Compliance Record of HPLC software 21CFR & Submitted
audit trail reports on product testing.
14. Record of Digital data logger for temperature and Submitted
humidity monitoring of stability chambers (real
time and accelerated)
REMARKS OF EVALUATOR (PEC-XVII)
Deficiency/Observation Response by Pharma.

Submit valid GMP certificate of M/s Wanbury limited, The firm submitted copy of GMP certificate of
Doctors Organic Chemicals Division, K. Illindalaparru M/s Wanbury limited, Doctors Organic
– 534217, Iragavaram Manadal, West Godavari District, Chemicals Division, K. Illindalaparru – 534217,
Andra Pradesh, India. Iragavaram Manadal, West Godavari District,
Andra Pradesh, India issued on dated 08-02-2022
by Drugs Control Administration, Andra Pradesh
India valid for three (03) years from the date of
issue.
In finished drug product testing method, standard and The firm re-submit finished drug product
sample absorbance are mentioned in the formula. analytical method with revised analysis formula.
However, dissolution and content uniformity tests are The firm further stated that since it is a
being performed on HPLC. Clarify or else revise typographical error and not a variation, fee is not
finished drug product testing method as per employed applicable as per notifications 7-11/2012-
testing methods. B&A/DRAP dated 07-05-2021 & 13-07-2021.
Submit CoA of working standard Firm submitted CoA of working standard.
B&A/DRAP dated 07-05-2021 before issuance of registration letter.
 Manufacturer will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months as per the commitment submitted
in the registration application.
 Manufacturer will perform process validation of first three batches as per the
commitment submitted in the registration application.
Diary No. Date of R& I & fee Dy. No.6521 dated 14-02-2019, Fee Rs: 50,000/-
dated 23-11-2018 vide deposit slip No.0809687
Me-too status NA
sections only
Oral liquid section
Remarks of the Evaluator Tablet (General) Section (Revised) approval granted
III) dated 22-06-2018.
Province, China.
Metformin Hydrochloride: MT01130220

Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. JMXB-T2-20 JMXB-T3-20 JMXB-T4-20
No. of Batches 03
months.
studies conducted from 9 months to onward was
on 21 CFR compliant. HPLC. Q.C .NO 122
Adequate monitoring and control were available
for stability chamber. The report shows that:
 The HPLC software is 21 CFR compliant as per
record available with the firm.
 Audit Trail on the testing reports on Tenofovir
Alafenamide Fumarate API and Vireof-N
tablets 25mg is available.
 The firm has adequate monitoring and control
system for stability chambers.
2. Certificate of Analysis of API from both API 1. Copy of COA (Batch#L-E-20200409-D01-
pharmaceuticals (Pvt) Ltd. Lahore is
submitted.
2. Copy of COA (Batch#MT01130220) of API
(Metformin hydrochloride) from M/s
M/s CCL pharmaceuticals (Pvt) Ltd. Lahore is
submitted.
Batches:(20160606,20161017,20161219)
provided.
9, 12, 18, 24, 36, 48, 60 & 0, 1, 2, 3 & 6 months
respectively.
MET-E-06660908)
Metformin HCl (1280Kgs, Batch No.
study

applicable)
JMXB-T2-20 1000 tablets 08-2020

JMXB-T3-20 1000 tablets 08-2020
JMXB-T4-20 1000 tablets 08-2020

Synjardy XR tablet (5/1000mg) Batch No.
6.8)
audit trail reports on product testing
Remarks of Evaluator (PEC-XVII)

issue.
being performed on HPLC. Clarify or else revise typographical error and not a variation, fee is not
testing methods. B&A/DRAP dated 07-05-2021 & 13-07-2021.
Submit CoA of working standard Firm submitted CoA of working standard.
Manufacturer will perform process validation of first three batches as per the
Brand Name +Dosage Form + Strength JARDY-MET XR 12.5mg/1000mg Tablet
Empagliflozin……….12.5mg
Diary No. Date of R& I & fee Dy. No.6522 dated 14-02-2019 , Fee Rs: 50,000/-
Approval status of product in Synjardy XR 12.5/1000mg film coated tablets
Me-too status NA
sections only
Oral liquid section
III) dated 22-06-2018.
Province, China.

Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. JMXC-T2-20 JMXC-T3-20 JMXC-T4-20
No. of Batches 03
months.
 Adequate monitoring and control were
available for stability chamber.
submitted.
submitted.
Batches:(20160606,20161017,20161219)
provided.
9, 12, 18, 24, 36, 48, 60 & 0, 1, 2, 3 & 6 months
respectively.
MET-E-06660908)
study

applicable)
JMXC-T2-20 1000 tablets 09-2020

JMXC-T3-20 1000 tablets 09-2020
JMXC-T4-20 1000 tablets 09-2020

Synjardy XR tablet (12.5/1000mg) Batch No.
6.8)

issue.
being performed on HPLC. clarify or else revise typographical error and not a variation, fee is not
testing mthods. B&A/DRAP dated 07-05-2021 & 13-07-2021.
Submit COA of working standard. Firm submitted CoA of working standard.
 Manufacturer will perform process validation of first three batches as per the commitment
submitted in the registration application.
Diary No. Date of R& I & fee Dy. No.6523 dated 14-02-2019 , Fee Rs: 50,000/-
Me-too status NA
sections only
Oral liquid section
III) dated 22-06-2018.
Province, China.

Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. JMXD-T2-20 JMXD-T3-20 JMXD-T4-20
No. of Batches 03
months.
 Adequate monitoring and control were available
for stability chamber.
submitted.
submitted.
Batches:(20160606,20161017,20161219)
provided.
9, 12, 18, 24, 36, 48, 60 & 0, 1, 2, 3 & 6 months
respectively.
MET-E-06660908)
study

applicable)
JMXD-T2-20 1000 tablets 09-2020

JMXD-T3-20 1000 tablets 09-2020
JMXD-T4-20 1000 tablets 09-2020

Synjardy XR tablet (25/1000mg), Batch No.
3167491 in HCl buffer (pH 1.2), Acetate buffer
(pH 4.5) & Phosphate buffer (pH 6.8)

issue.
In finished drug product testing methods, standard and The firm re-submit finished drug product
sample absorbance are mentioned in the formula, analytical method with revised analysis formula.
however, in the submitted method, dissolution and The firm further stated that since it is a
content uniformity tests are being performed on HPLC. typographical error and not a variation, fee is not
Revise finished drug product testing method as per applicable as per notifications 7-11/2012-
method employed/performed. B&A/DRAP dated 07-05-2021 & 13-07-2021.
Submit COA of working standard. Firm submitted CoA of working standard
 Manufacturer will perform process validation of first three batches as per the
498. Name and address of manufacturer / Applicant Applicant: M/s CCL Pharmaceuticals (Pvt.) Ltd. 62-
Industrial Estate, Kot Lakhpat, Lahore.
Manufacturer: M/s Nabiqasim Industries Pvt. Ltd.
17/24, Korangi Industrial Area, Karachi, Pakistan.
Brand Name +Dosage Form + Strength COLIST INJECTION 2 million IU
Lyophilized Powder for solution for injection/infusion
Colistimethate Sodium……………2 million IU
Diary No. Date of R& I & fee Dy. No 11107 Dated 05-03-2019, Rs. 50,000/- dated
05-03-2019
Type of Form Form-5
Finished product Specifications BP
Approval status of product in COLOMYCIN 2 million International Units (IU) (UK)
Reference Regulator Authorities
Me-too status Colistimethate Sodium powder for solution for IV
injection/infusion of M/s Mukhtar Enterprises Lahore.
Registration No. 094757
sections only
Oral liquid section
Remarks of the Evaluator Decision of 293rd meeting of Drug Registration Board
“Deferred for submission of product development
data.”
Manufacturer of API M/s Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
API Lot No. CMSG 1902001
Description of Pack Vial (transparent glass vial, 10ml)
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. 359DS01 359DS02 359DS03
Batch Size 300 vials 300 vials 300 vials
Date of Initiation 07-2020 07-2020 07-2020
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to 307th meeting of DRB
with stability study data of the firm held from 08th-10th June,2021, wherein the
product Esorid 40mg IV injection has been
approved (Contract manufacturing) by referring
to the inspection report of M/s Nabiqasim
Industries, Karachi for their product Esomax
injection, presented in 294th meeting of DRB,
held on 9-04-2020. The board decided to approve
Esomax 40mg & Esvin 40mg injection (Contract
manufacturing).
However, it is also mentioned that the scope of the
inspection report pertains to the “authenticity of
formulation” only.
2. Certificate of Analysis of API from both API Copy of COA (Batch# CMSG 1902001) of API
Manufacturer and Finished Product from M/s Livzon Group Fuzhou Fuxing
manufacturer. Pharmaceutical Co., Ltd. 8 Nangang Road,
Jiangyin Industrial Concentration Zone, Fuqing,
Fuzhou City, Fujina Province, China and M/s
Nabiqasim Industries (Pvt.) Ltd. Karachi is
submitted.
4. Stability study data of API from API Stability study is conducted at Long Term
manufacturer conditions; 25°C ± 2°C / 60% ± 5%RH for 36
9, 12, 18, 24, 36 & 0, 1, 2, 3 & 6 months
respectively.
Batches:(CMS1707001,CMS1707002,
CMS1707003)
5. Approval of API/ DML/GMP certificate of API Firm has submitted copy of “Written
manufacturer issued by concerned regulatory confirmation for active substances exported to
authority of country of origin. EU” dated 22-09-2020 in the name of M/s Livzon
Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
No.8 Nangang Road, Jiangyin Industrial
Concentration Zone, Fuqing, Fuzhou City, Fujian
Province, China issued by Fujian, Food & Drug
Administration valid till 21-09-2022. It also states
that the manufacturing plant complies with the
requirements of the Chinese Good Manufacturing
practices (= GMP of EU, WHO/ICH Q7). The
drug does not have Chinese approval number as it
is for export-only.
The firm has also provided copy of Drug
Manufacturing License No. (Min) 20160089, of
M/s Livzon Group Fuzhou Fuxing
Pharmaceutical Co., Ltd. No.8 Nangang Road,
Fuzhou City, Fujian Province, China valid till 21-
09-2025. Details of API are not mentioned in the
DML. (DML verifiable online)
6. Documents for the procurement of API with Firm has submitted copy of invoice No.
approval from DRAP (in case of import). FXIN1902141D dated 20-03-2019 in the name of
M/s Nabiqasim Industries (Pvt) Ltd. Karachi,
attested by AD (I & E), DRAP Karachi vide No.
1541/21-05-19 dated 24/05/2019 for the import of
0.6kg Colistimethate sodium Non-sterile USP,
having batch No. CMSG1902001 from Livzon
Group Fuzhou Fuxing pharmaceutical co., Ltd.
China.
study
9. Drug-excipients compatibility studies According to the firm, the formulation has been
(Where applicable) developed as per reference product Colomycin 2
M IU (Teva limited, UK), the formulation of
colistimethate sodium 2 M IU is qualitatively
same as per reference product, hence
compatibility study not applicable.
The reference product contains no other
ingredients except colistimethate sodium.
359DS01 300 vials 07-2020

359DS02 300 vials 07-2020
359DS03 300 vials 07-2020
11. Record of comparative dissolution data (where Not applicable

applicable)
12. Data of 03 batches will be supported by attested Stability study data for Microbial assay
respective documents like chromatograms, Raw (Bioassay) in the form of inhibition zones
data sheets, CoA, summary data sheets etc. measurements provided
13. Compliance Record of HPLC software 21CFR & The product specifications of colistimethate
audit trail reports on product testing sodium injection based on USP and there is no
application of HPLC in testing method because
the assay method based on microbial assay
therefore compliance record of HPLC software 21
CFR and audit trail reports are not applicable

Provide API stability data as per Zone IV-A conditions. Firm submitted Stability studies data as per zone
Stability data provided at following conditions: IV-B and stated that it is more stressful than zone
Stability study is conducted at Long Term conditions; IV-A.
25°C ± 2°C / 60% ± 5%RH for 36 months and at
Accelerated conditions; 40°C ± 2°C / 75% ± 5%RH for
6 months.
Description & solubility specifications of API as Description and Solubility test are not present in
provided by the firm, termed as USP. However, these USP Monograph of Colistemethate Sodium.
specifications are mentioned as “In-house” by the API These are additional tests performed by API
manufacturer. Also do not exist in USP official Manufacturer in addition to USP Tests.
monograph of API.
Microbial contamination test/specifications provided in Microbial contamination test is mention in
CoA of API by the firm. However, in analytical testing Analytical Test Specification. This test is
method of API, the same test not mentioned/provided. performed as per <USP 61>.
The firm again provided CoA of API from drug
substance manufacturer.
Provide legible/clear copy of DML of API Firm submitted legible copy of DML of API
manufacturer. manufacturer.
The firm has mentioned in stability studies protocol, the As per USP Monograph, Sterility test is not
Sterility test but the same is not available in stability required for API testing. According to USP
studies data. Colistimethate Sodium must be subjected to
further processing during the preparation of
injectable dosage forms.
Response of the firm has not clarified the
query/observation.
CoA of reference/working standard not provided. Reference standard CoA will be provided.
However, API Manufacturer CoA of lot being
used in Developmental studies provided.
Justify use of non-sterile API (as evident from lack of As per USP Monograph, when label states
sterility testing in CoA & import invoice of API) in that Colistimethate Sodium must be subjected to
manufacturing of injectable dosage form as labelling further processing during the preparation of
requirements of Colistimethate Sodium USP states injectable dosage forms, it meets the
“Where it is intended for use in preparing injectable requirements for Bacterial endotoxins. As per
dosage forms, the label states that it is sterile or must besubmitted Manufacturing Record and CoA of
subjected to further processing during the preparation of FPP, BET is performed according to USP.
injectable dosage forms. However, as per manufacturing
record of trial batches submitted, the sterilization However, it is stated that as per manufacturing
process not mentioned. record of trial batches submitted by the firm,
there is no details regarding the “further
processing”.
USP monograph for Colistimethate sodium
include the following labelling requirements:
Labeling—Where it is intended for use in
preparing injectable dosage forms, the label
states that it is sterile or must be subjected to
Other requirements—Where the label states that
Colistimethate Sodium is sterile; it meets the
requirements for Sterility and Bacterial
endotoxins under Colistimethate for Injection.
Where the label states that Colistimethate
Sodium must be subjected to further processing
during the preparation of injectable dosage
forms, it meets the requirements for Bacterial
 Justify the following: The determined potency is equal to 100.0% in
terms of CBA. Hence, dispensed quantity is
 Dispensed quantity of Colistimethate Sodium 52.174g for trial batch manufacturing of 2MIU
against the determined potency in terms of and 78.261g for trial batch manufacturing of
Colistimethate base activity (CBA). 3MIU, having batch size of 300vials. As 1mg of
Colistemethate Sodium is equivalent to 11500IU
of Colistemethate Sodium.
As per USP monograph for Colistimethate

Sodium “Colistimethate Sodium has a potency
equivalent to not less than 390 µg of colistin per
mg. In both CoAs (drug substance manufacture
& drug product manufacturer, the Assay (on the
as-is basis) given as ≥390µg/mg. The nominal
potency of Colistimethate sodium is 12500IU/mg,
while the firm claimed as 11500IU/mg. It is not
clarified as to how the determined potency
claimed as 100% in terms of CBA.
USP states the following Label claim

 Since firm has claimed USP specifications.
Justify the declared label claim in terms of “Colistimethate for Injection contains an amount
Colistimethate sodium instead of of Colistimethate Sodium equivalent to not less
Colistimethate base activity as recommended than 90.0 percent and not more than 120.0
by USP. percent of the labeled amount of colistin”. Same
claim has been recommended by the firm.
The firm label claim mentioned in terms of IU,
not colistimethate base activity.
Submitted CoA mention the potency in terms of

both CBA and IU of CMS. CoA again submitted
 Submitted CoA does not clarify the potency for reference.
whether in terms of CBA or IU of CMS. As per USP monograph for Colistimethate
Sodium “Colistimethate Sodium has a potency
equivalent to not less than 390 µg of colistin per
mg. In both CoAs (drug substance manufacture
& drug product manufacturer, the Assay (on the
as-is basis) given as ≥390µg/mg. The nominal
potency of Colistimethate sodium is 12500IU/mg,
while the firm claimed as 11500IU/mg.
 As per stability data sheets/reports submitted, the Content Uniformity test will be performed every
content uniformity test data not provided. Submit 10th Batch and data will be submitted
accordingly.
content uniformity test data in line with USP general
chapter <905> UNIFORMITY OF DOSAGE UNITS.
 The microbial assay performed is not completely as per As per USP <81>, Microbial Assay should be
USP monograph for “Colistimethate for Injection”, performed by cylinder plate assay (Diffusion
general chapter “Antibiotics—Microbial Assays <81>”, Method), same is adopted by the firm. As far as
particularly the standard dilutions preparation, assay concentrations are concerned, Concentrations
calculation/analysis etc. It is therefore required to recommended by USP is 1mg/ml and
clarify and justify as to how the adopted assay concentration adopted by the firm for low dose is
procedure and data analysis is in accordance with USP 0.8mg/ml i.e., approximately 1.0mg/ml.
general chapter of microbial assay <81>, both for drug
substance & drug product.
The firm has submitted specifications for the finished It was typographical error in form 5. Otherwise,
drug product as per USP. However, the specifications specifications of drug product are derived from
previously mentioned in Form-5, which was presented USP.
in 293rd meeting of registration board, wherein the board
deferred the application for submission of stability study
data, the specifications have been mentioned as BP. It is
therefore advised to submit applicable fee as per
notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021 for drug product specifications revision.
 Provide contract manufacturing agreement. It will be provided.
 Please provide number of vials consumed for one time- As per testing specification 5 vials be used for
point. real time and 5 for accelerated. Total 10 vial till
6Month time point and then 5 vials till claimed
shelf life.
 Submit minimum handling capacity for processing of It will be provided.
Colistemethate Sodium trial batches (Trial batch bulk
volum given 600ml)

 The firm has mentioned in stability studies protocol, the Sterility test but the same is not
available in stability studies data.
 Justify use of non-sterile API (as evident from lack of sterility testing in CoA & import invoice
of API) in manufacturing of injectable dosage form as labelling requirements of Colistimethate
Sodium USP states “Where it is intended for use in preparing injectable dosage forms, the label
states that it is sterile or must be subjected to further processing during the preparation of
injectable dosage forms. However, as per manufacturing record of trial batches submitted, the
sterilization process not mentioned.
 Justification for dispensed quantity of Colistimethate Sodium against the determined potency in
terms of Colistimethate base activity (CBA).
 Justification of declared label claim in terms of Colistimethate sodium instead of Colistimethate

base activity as recommended by USP as the firm claimed USP specifications for finished drug
product.
 Submitted CoA does not clarify the potency whether in terms of CBA or IU of CMS.
 As per stability data sheets/reports submitted, the content uniformity test data not provided.
Submit content uniformity test data in line with USP general chapter <905> UNIFORMITY OF
DOSAGE UNITS.
 The microbial assay performed is not completely as per USP monograph for “Colistimethate for
Injection”, general chapter “Antibiotics—Microbial Assays <81>”, particularly the standard
dilutions preparation, assay calculation/analysis etc.
 Submission of minimum handling capacity for processing of Colistemethate Sodium trial
batches (Trial batch bulk volume given 600ml)
 Submission of contract manufacturing agreement.
499. Name and address of manufacturer / Applicant Applicant: M/s CCL Pharmaceuticals (Pvt.) Ltd. 62-
Industrial Estate, Kot Lakhpat, Lahore.
Manufacturer: M/s Nabiqasim Industries Pvt. Ltd.
17/24, Korangi Industrial Area, Karachi, Pakistan.
Brand Name +Dosage Form + Strength COLIST INJECTION 3 Million IU
Lyophilized Powder for solution for injection/infusion
Colistimethate Sodium ……… 3 million IU
Diary No. Date of R& I & fee Dy. No 11108 Dated 05-03-2019, Rs. 50,000/- dated
05-03-2019
Type of Form Form-5
Approval status of product in MHRA approved
Reference Regulator Authorities
Me-too status Colistimethate Sodium powder for solution for IV
injection/infusion of M/s Mukhtar Enterprises Lahore.
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”.
DML of M/s Nabiqasim by way of formulation 12-07-
2014 & GMP inspection by inspectors dated 03-08-
2017 shows the acceptable level of compliance of
GMP.
Remarks of the Evaluator Decision of 293rd meeting of Drug Registration
Board “Deferred for submission of product
development data.”
Manufacturer of API M/s Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
API Lot No. CMSG 1902001
Description of Pack Vial (transparent glass vial, 10ml)
Accelerated: 40 °C ± 2 °C / 75% ± 5%
Batch No. 360DS01 360DS02 360DS03
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to 307th meeting of DRB
with stability study data of the firm held from 08th-10th June,2021, wherein the
product Esorid 40mg IV injection has been
approved (Contract manufacturing) by referring
to the inspection report of M/s Nabiqasim
Industries, Karachi for their product Esomax
injection, presented in 294th meeting of DRB,
held on 9-04-2020. The board decided to approve
Esomax 40mg & Esvin 40mg injection (Contract
manufacturing).
However, it is also mentioned that the scope of the
inspection report pertains to the “authenticity of
formulation” only.
2. Certificate of Analysis of API from both API Copy of COA (Batch# CMSG 1902001) of API
Manufacturer and Finished Product from M/s Livzon Group Fuzhou Fuxing
manufacturer. Pharmaceutical Co., Ltd. 8 Nangang Road,
Fuzhou City, Fujina Province, China and M/s
Nabiqasim Industries (Pvt.) Ltd. Karachi is
submitted.
4. Stability study data of API from API Stability study is conducted at Long Term
manufacturer conditions; 25°C ± 2°C / 60% ± 5%RH for 36
9, 12, 18, 24, 36 & 0, 1, 2, 3 & 6 months
respectively.
Batches:(CMS1707001,CMS1707002,
CMS1707003)
5. Approval of API/ DML/GMP certificate of API Firm has submitted copy of “Written
manufacturer issued by concerned regulatory confirmation for active substances exported to
authority of country of origin. EU” dated 22-09-2020 in the name of M/s Livzon
Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
No.8 Nangang Road, Jiangyin Industrial
Concentration Zone, Fuqing, Fuzhou City, Fujian
Province, China issued by Fujian, Food & Drug
Administration valid till 21-09-2022. It also states
that the manufacturing plant complies with the
requirements of the Chinese Good Manufacturing
practices (= GMP of EU, WHO/ICH Q7). The
drug does not have Chinese approval number as it
is for export-only.
The firm has also provided copy of Drug
Manufacturing License No. (Min) 20160089, of
M/s Livzon Group Fuzhou Fuxing
Pharmaceutical Co., Ltd. No.8 Nangang Road,
Fuzhou City, Fujian Province, China valid till 21-
09-2025. Details of API are not mentioned in the
DML. (DML verifiable online)
6. Documents for the procurement of API with Firm has submitted copy of invoice No.
approval from DRAP (in case of import). FXIN1902141D dated 20-03-2019 in the name of
M/s Nabiqasim Industries (Pvt) Ltd. Karachi,
attested by AD (I & E), DRAP Karachi vide No.
1541/21-05-19 dated 24/05/2019 for the import of
0.6kg Colistimethate sodium Non-sterile USP,
having batch No. CMSG1902001 from Livzon
Group Fuzhou Fuxing pharmaceutical co., Ltd.
China.
study
9. Drug-excipients compatibility studies According to the firm, the formulation has been
(Where applicable) developed as per reference product Colomycin 2
M IU (Teva limited, UK), the formulation of
colistimethate sodium 2 M IU is qualitatively
same as per reference product, hence
compatibility study not applicable.
The reference product contains no other
ingredients except colistimethate sodium.
360DS01 300 vials 07-2020

360DS02 300 vials 07-2020
360DS03 300 vials 07-2020
11. Record of comparative dissolution data (where Not applicable

applicable)
12. Data of 03 batches will be supported by attested Stability study data for Microbial assay
respective documents like chromatograms, Raw (Bioassay) in the form of inhibition zones
data sheets, COA, summary data sheets etc. measurements provided
Firm has submitted record of testing of all batches
including COA and summary data sheets.
13. Compliance Record of HPLC software 21CFR & The product specifications of colistimethate
audit trail reports on product testing sodium injection based on USP and there is no
application of HPLC in testing method because
the assay method based on microbial assay
therefore compliance record of HPLC software 21
CFR and audit trail reports are not applicable
REMARKS OF EVALUATOR (PEC-XVII)

Provide API stability data as per Zone IV-A conditions. Firm submitted Stability studies data as per zone
As stability data provided at following conditions: IV-B and stated that it is more stressful than zone
Stability study is conducted at Long Term conditions; IV-A.
25°C ± 2°C / 60% ± 5%RH for 36 months and at
Accelerated conditions; 40°C ± 2°C / 75% ± 5%RH for
6 months at intervals 0, 3, 6, 9, 12, 18, 24, 36 & 0, 1, 2,
Description & solubility specifications of API as Description and Solubility test are not present in
provided by the firm, termed as USP. However, these USP Monograph of Colistemethate Sodium.
specifications are mentioned as “In-house” by the API
manufacturer. Also do not exist in USP official These are additional tests performed by API
monograph of API. Manufacturer in addition to USP Tests.
Microbial contamination test/specifications given in Microbial contamination test is mention in
API CoA by the firm. However, in analytical testing Analytical Test Specification. This test is
method of API, the same test not mentioned/provided. performed as per <USP 61>.
The firm again provided CoA of API from drug
substance manufacturer.
Provide legible/clear copy of DML of API Firm submitted legible copy of DML of API
manufacturer. manufacturer.
Initiation of stability studies mentioned as July-2020 in
stability studies protocols, however, as per Stability
study data sheet of trial batches, the initiation date given
as 10-08-2020.
The firm has mentioned in stability studies protocol, the As per USP Monograph, Sterility test is not
Sterility test but the same has not been mentioned in required for API testing. According to USP
stability studies data. Colistimethate Sodium must be subjected to
Response of the firm has not clarified the
query/observation.
CoA of reference standard not provided. Reference standard CoA will be provided.
However, API Manufacturer CoA of lot being
used in Developmental studies provided.
Justify use of non-sterile API (as evident from lack of As per USP Monograph, when label states
sterility testing in CoA & import invoice of API) in that Colistimethate Sodium must be subjected to
manufacturing of injectable dosage form as labelling further processing during the preparation of
requirements of Colistimethate Sodium USP states injectable dosage forms, it meets the
“Where it is intended for use in preparing injectable requirements for Bacterial endotoxins. As per
dosage forms, the label states that it is sterile or must be submitted Manufacturing Record and CoA of
subjected to further processing during the preparation of FPP, BET is performed according to USP.
injectable dosage forms. However, as per manufacturing
record of trial batches submitted, the sterilization However, it is stated that as per manufacturing
process not mentioned. record of trial batches submitted by the firm,
there is no details regarding the “further
processing”.
USP monograph for Colistimethate sodium
include the following labelling requirements:
Labeling—Where it is intended for use in
preparing injectable dosage forms, the label
states that it is sterile or must be subjected to
Other requirements—Where the label states that
Colistimethate Sodium is sterile; it meets the
requirements for Sterility and Bacterial
Where the label states that Colistimethate
Sodium must be subjected to further processing
during the preparation of injectable dosage
forms, it meets the requirements for Bacterial
In API CoA, the assay limit given “on dried basis” as
11500 IU/mg, that has been used for trial batch
calculation. The nominal potency of colistimethate
sodium is 12500 IU/mg, which is more than that given
for dried basis. Clarification is required regarding batch
calculation on dried basis assay. Moreover, loss on
drying limit mentioned in both API and finished drug
product CoA is the same (not more than 7%).
Clarification is required that how the content uniformity Content Uniformity test will be performed every
test is in accordance with USP general chapter <905> 10th Batch and data will be submitted
UNIFORMITY OF DOSAGE UNITS. Also clarify as accordingly.
to why the content uniformity test has not been
performed at the required time point during stability
studies as evident from the stability data sheets/reports
submitted.
Contract manufacturing agreement required or not? It will be provided.
The microbial assay performed is not as per USP As per USP <81>, Microbial Assay should be
monograph for “Colistimethate for Injection”, general performed by cylinder plate assay (Diffusion
chapter “Antibiotics—Microbial Assays <81>”. It is Method), same is adopted by the firm. As far as
therefore required to clarify and justify as to how the concentrations are concerned, Concentrations
assay procedure followed and data submitted is in recommended by USP is 1mg/ml and
accordance with USP general chapter of microbial assay concentration adopted by the firm for low dose is
<81>, both for drug substance & drug product. 0.8mg/ml i.e., approximately 1.0mg/ml.
The firm has submitted specifications for the finished It was typographical error in form 5. Otherwise,
drug product as per USP. However, the specifications specifications of drug product are derived from
previously mentioned in Form-5, which was presented USP.
in 293rd meeting of registration board, wherein the board
deferred the application for submission of stability study
data, the specifications have been mentioned as BP. It is
therefore advised to submit applicable fee as per
& 13-07-2021 for drug product specifications revision.
The number of vials for stability studies of each batch As per testing specification 5 vials be used for
given as 130vials and 60 vials for long term and real time and 5 for accelerated. Total 10 vial till
accelerated stability studies respectively. Please specify, 6Month time point and then 5 vials till claimed
number of vials that has been utilized at each test point shelf life.
with reference to the tests performed.
 The firm has mentioned in stability studies protocol, the Sterility test but the same is not
available in stability studies data.
 Justify use of non-sterile API (as evident from lack of sterility testing in CoA & import invoice
of API) in manufacturing of injectable dosage form as labelling requirements of Colistimethate
Sodium USP states “Where it is intended for use in preparing injectable dosage forms, the label
states that it is sterile or must be subjected to further processing during the preparation of
injectable dosage forms. However, as per manufacturing record of trial batches submitted, the
sterilization process not mentioned.
 Justification for dispensed quantity of Colistimethate Sodium against the determined potency in
terms of Colistimethate base activity (CBA).
 Clarification for considering nomial potency as 11500 IU/mg, for trial batch calculation is
required. Since the nominal potency of Colistimethate sodium in literature is given as 12500
IU/mg.
 Justification of declared label claim in terms of Colistimethate sodium instead of Colistimethate
base activity as recommended by USP as the firm claimed USP specifications for finished drug
product.
 Initiation of stability studies mentioned as July-2020 in stability studies protocols, however, as
per Stability study data sheet of trial batches, the initiation date given as 10-08-2020.
 Submitted CoA does not clarify the potency whether in terms of CBA or IU of CMS.
 As per stability data sheets/reports submitted, the content uniformity test data not provided.
Submit content uniformity test data in line with USP general chapter <905> UNIFORMITY OF
DOSAGE UNITS.
 The microbial assay performed is not completely as per USP monograph for “Colistimethate for
Injection”, general chapter “Antibiotics—Microbial Assays <81>”, particularly the standard
dilutions preparation, assay calculation/analysis etc.
 Submission of minimum handling capacity for processing of Colistimethate Sodium trial batches
(Trial batch bulk volume given 600ml)
Case No. 2: Registration applications for local manufacturing of (Human) drugs:

(Differential Fee cases)
a. New cases:
500. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozpur
Applicant Road, Lahore.
Brand Name + Dosage Form + Strength Tolteri 4mg capsule
Tolterodine tartrate......4mg.
Diary No. Date of R & I & fee Dy.No. 513 dated 03-12-2012, Fee Rs: 8,000/-,
Date.03-12-2012 (Challan photocopy dated 29-11-
2012 provided)
Dy.No. 410 dated 31-03-2015, Differential fee: Rs.
12,000 Dated 31-03-2015 (Challan No.0300889 dated
26-03-2015, photocopy provided)
“Duplicate dossier, R & I verified”
Pharmacological Group Anti-cholinergic agent
Type of Form Form-5
Finished product Specification Manufacturer specifications
Approval status of product in Reference Detrusitol XL 4 mg, prolonged-release capsules, hard
Regulatory Authorities (MHRA approved)
Me-too status Urot 4mg capsules by Ciba pharmaceuticals, Karachi.
GMP status GMP certificate issued on 21-05-2019 based on
inspection conducted on 29-01-2019
Panel GMP inspection report dated 23-04-2019 also
submitted.
Remarks of the Evaluator (PEC-XVII)  Revise label claim/composition, as per reference
product as:
Each capsule contains:
Tolterodine tartrate Sustained Release Pellets 2% Eq.
to Tolterodine tartrate… 4mg
 The manufacturing outlines need further elaboration
as firm has mentioned mixing of dummy pellets with
drug pellets in polybag.
 GMP inspection report conducted within last 03years
is required.
 The firm has mentioned tolterodine tartrate sustained
release pellets 2%. Please provide source of pellets,
stability studies data of 3 batches, GMP certificate of
pellets manufacturer, COA of pellets and submit
differential fee in case of imported pellets source.
 Firm has provided COA, accelerated and long-term
stability data for one batch.
 Provide evidence of approval of required
manufacturing facilities by Licensing Division.
 For above revision, submit applicable fee as per
notifications 7-11/2012-B&A/DRAP dated 07-05-
2021 & 13-07-2021.
 Revision of label claim/composition as per reference product as:
Tolterodine tartrate Sustained Release Pellets 2% Eq. to Tolterodine tartrate… 4mg
 Evidence of requisite mixing facilities for sustained release drug pellets with dummy pellets
as in the manufacturing outlines provided shown the mixing process performance in
polybag.
 Sustained release pellets source, CoA, stability study data of three batches of pellets and
GMP certificate of pellets manufacturer.
 Most recent GMP audit report from QA & LT division valid within last three years.
 Submission of applicable fee for composition revision and pellets source approval/fixation
as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
501. Name and address of manufacturer/ Masfa Industries (Pvt.) Ltd. 17-Km, Sheikhupura
Brand Name + Dosage Form + Strength TAMIZOLE Suspension
Benzoyl metronidazole……320mg
Diloxanide furoate…………250mg
Diary No. Date of R & I & fee Dy.No. 928 Dated: 01-06-2011, Fee Rs: 8,000/-, Dated
01-06-2011 (photo copy)
Dy.No. 80 dated 05-01-2016, Differential fee Rs:
12,000/- Dated 29-12-2015 (photo copy)
Pharmacological Group Antiamoebic
Type of Form Form-5
Pack size & Demanded Price 1 × 90ml, Rs: 34.00/90ml bottle
Approval status of product in Reference Could not be confirmed
Me-too status Zolt suspension (Metronidazole benzoate eq to
metronidazole: 200mg; Diloxanide Furoate: 250mg)
per 10ml of M/s Stanley Pharmaceuticals, Peshawar.
GMP status Not provided
Remarks of the Evaluator (PEC-XVII)  Provide evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
adopted by the Registration Board in its 275th meeting.
 Firm has claimed manufacturer specifications, while
the product is non-pharmacopoeial.
 The generic/me-too has Metronidazole (as

metronidazole benzoate) ….200mg
Benzoyl metronidazole is the synonym for
metronidazole benzoate.
 Provide evidence of relevant section approval by
Licensing Division, DRAP Islamabad.
 Provide recent/last GMP inspection report.
 Differential fee for two products Peptic-C suspension

and Tamizole suspension submitted vide same challan
No.0515191 dated 23-12-2015. Amount submitted is
24000/- for two products.

authorities/agencies which were declared/approved by the Registration Board in its
275th meeting.
 Submission of most recent GMP audit report conducted within last 03 years.
 Evidence of approval of requisite manufacturing facilities/ section by Licensig
Division, DRAP Islambad.
Brand Name + Dosage Form + Strength ECEPHYL cough syrup
Acefylline piperazine……...45mg
Diphenhydramine HCl……8mg
Diary No. Date of R & I & fee Dy.No. 930 Dated: 01-06-2011, Fee Rs: 8,000/-, Dated
01-06-2011 (photo copy)
12,000/- Dated 29-12-2015 (photo copy)
Pharmacological Group Cough and anti-histamine
Type of Form Form-5
Pack size & Demanded Price 1 × 60ml, Rs: 35.00/60ml bottle
Me-too status Acelyf syrup of M/s Hicon Pharmaceuticals, Peshawar.
Remarks of the Evaluator (PEC-XVII)
 Provide evidence of approval of applied formulation in
 The firm has claimed manufacturer specifications.

While the product is non-pharmacopoeial.
 Provide evidence of relevant section approval.
 Provide recent/last GMP inspection report conducted

within last 03 years.
 Differential fee of Rs: 24,000/- for two products

Ecephyl cough syrup and Otillion suspension
submitted vide same challan No.0515190 dated 23-12-
2015.

275th meeting.
 Evidence of approval of requisite manufacturing facilities/ section by Licensig
Brand Name + Dosage Form + Strength PEPTIC-C suspension
Famotidine…….10mg
Diary No. Date of R & I & fee Dy.No. 4042 Dated: 02-04-2011, Fee Rs: 8,000/-,
Dated 01-04-2011 (photo copy)
12,000/- Dated 29-12-2015 (photo copy),
Pharmacological Group H2 receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 1 × 60ml, Rs: 68.64.00/60ml bottle
Me-too status Dinex suspension of M/s Gulf Pharmaceuticals,
National Industrial Zone, Rawat. Registration No.
075050

While the product is non-pharmacopoeial.
 Provide evidence of relevant section approval.
 Provide recent/last GMP inspection report conducted

within last three years.
 Differential fee of Rs: 24,000/- for two products
Peptic-C suspension and Tamizole suspension
submitted vide same challan No.0515191 dated 23-12-
2015.
275th meeting.
 Submission of approval of requisite manufacturing facilities/ section by Licensig
504. Name and address of manufacturer/ Bosch Pharmaceuticals (Pvt.) Ltd., Plot No.221-223,
Applicant Sector 23, Korangi Industrial Area, Karachi. (DML No.
000350, Plant-I)
Brand Name + Dosage Form + Strength QMETEM-P 40mg/ml Injection (I/M)
Composition Each 1ml ampoule contains:
Artemether ……40mg
Diary No. Date of R & I & fee Dy. No. 197 dated 14-03-2011, Fee Rs: 8,000/- (Photo
copy), Dy.No. 187 Dated 04-10-2013, Differential fee
Rs. 12,000/- dated 25-09-2013 vide challan No.
0003744 Dated 09-09-2013
(Duplicate Dossier, R & I verified)
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished product Specification Firm has claimed manufacturer specifications
Pack size & Demanded Price 10’s & 5’s, as per SRO
Approval status of product in Reference Strength in the current WHO Model List of Essential
Regulatory Authorities Medicines (EML): 80 mg/mL in 1 mL ampoule; other
available strengths: 40 mg/mL (paediatric
formulation), 60 mg/mL, 100 mg/mL (adult
formulation).
Me-too status Ufan Injection 40mg/ml of M/s S.J & G Fazul Ellahie
(PVt) Ltd. Karachi. Registration No.067038
Misomal 40mg/ml Injection of M/s Tabros pharma,
Karachi. Registration No. 066759
GMP status GMP compliance inspection report conducted within
last three years not provided.
Remarks of the Evaluator (PEC-XVII)  Provide Challan copy of differential fee submitted in
the year 2013.
 Provide evidence of approval of applied formulation

in reference regulatory authorities / agencies which
were adopted by the Registration Board in its 275th
meeting.
 The firm has claimed manufacturer specifications,

however monograph available in International
Pharmacopoeia.
 Provide evidence of approval of relevant section by

 Provide most recent GMP inspection report

conducted within last 03 years.
Decision: Deferred for:
 Evidence of approval of applied formulation in reference regulatory authorities /
agencies/ recommendation by WHO as per decision of Registration Board in its 275th
meeting.
 Latest GMP inspection report conducted within last three years.
 Revision of finished drug product specifications as per international pharmacopoeia
alongwith fee of Rs. 7,500 for correction/pre-approval change/ in product
specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
505. Name and address of manufacturer/ Bosch Pharmaceuticals (Pvt.) Ltd., Plot No.209, Sector
Applicant 23, Korangi Industrial Area, Karachi.
(DML No. 000707, Plant-II)
Brand Name + Dosage Form + Strength FLUGAL 100mg/50ml (IV infusion)
Composition Each 50ml vial contains:
Fluconazole USP ……100mg
Diary No. Date of R & I & fee Dy. No. 64 dated 07-09-2011 Initial Fee Rs: 8,000/-
Dated 16-06-2011 (Challan Photo copy),
Differential fee Rs. 12,000/- Dated 16-12-2015 (Photo
copy)
“Duplicate Dossier, R & I verified”
Pharmacological Group Anti-fungal, triazole derivative
Type of Form Form-5
Pack size & Demanded Price 1 Vial, as per PRC policy
Approval status of product in Reference Diflucan™ 2 mg/ml solution for infusion (Pfizer Ltd.
Regulatory Authorities UK. MHRA approved) (25ml, 50ml, 100ml & 200ml
solution for infusion in glass vials)
Me-too status Derozol 100mg/50ml Injection of Rotex Pharma (Pvt)
Ltd. Islamabad. Registration No. 092334
GMP status Routine GMP inspection conducted on 01-12-2021
with conclusion:
Based on the areas inspected, the people met and the
documents reviewed, and considering the findings of
the inspection, including the observations listed in the
Inspection Report, M/s Bosch Pharmaceuticals (Pvt.)
Limited, located at Plot No.209, Sector-23, Korangi
Indusrial Area, Karachi was considered to be operating
at an acceptable level of compliance with GMP
guidelines as of today.
Remarks of the Evaluator (PEC-XVII)  Firm has mentioned manufacturer specifications for
the finished drug product while official monograph
for finished drug product is available. Revise the
finished drug product specifications as per official
monograph. (Fluconazole in Dextrose injection and
Fluconazole in Sodium Chloride injection, USP has
separate monographs).
 The primary container for the reference product is
type I while you have mentioned USP type II. Please
calrify?
 Provide copy of covering letter for differential fee
submission (2015), bearing statistical officer and
DRAP R & I stamp.
2021 & 13-07-2021.
 Firm has manufacturing facilities for Sterile infusion
(General) as per GMP certificate issued on 17-07-
2020 based on evaluation conducted on 26-06-2019.
Decision: Approved as per USP specifications with Type I glass vial as primary container.
The firm shall submit fee of Rs. 7,500 for correction/pre-approval change/ in product
Registration Board further decided to verify fee challan as per decision of 285 th meeting of
Registration Board.
(Plant-II)
Diary No. Date of R & I & fee Dy. No. 54 dated 07-09-2011 Initial Fee Rs: 8,000/-
Dated 16-06-2011 (Challan Photo copy),
Differential fee Rs. 12,000/- Dated 16-12-2015 (Photo
copy)
Type of Form Form-5
Me-too status Konacane 200mg/100ml Infusion of Pharmasol (Pvt)
Ltd, Lahore. Registration No. 102577
with conclusion:
Indusrial Area, Karachi was considered to be
operating at an acceptable level of compliance with
GMP guidelines as of today.
 Firm has mentioned manufacturer specifications for
clarify?
 Provide last/recent GMP inspection report conducted
DRAP R & I stamp.

2021 & 13-07-2021.
 Firm has manufacturing facilities for Sterile infusion

Decision: Approved as per USP specifications with Type I glass vial as primary container.
The firm shall submit fee of Rs. 7,500 for correction/pre-approval change/ in product
 Registration Board further decided to verify fee challan as per decision of 285 th
Applicant 23, Korangi Industrial Area, Karachi. (Plant-II)
Diary No. Date of R & I & fee Dy. No. 56 dated 07-09-2011 Initial Fee Rs:8,000/-
Dated 16-06-2011 (Challan Photo copy), Differential
fee Rs.12,000/- Dated 16-12-2015 (Photo copy)
Type of Form Form-5
with conclusion:
Indusrial Area, Karachi was considered to be
operating at an acceptable level of compliance with
GMP guidelines as of today.
Remarks of the Evaluator (PEC-XVII)  Firm has mentioned manufacturer specifications for
clarify?
 Provide last/recent GMP inspection report conducted
DRAP R & I stamp.
 Provide evidence of drug already approved by DRAP

(Generic/me-too) along with brand name, registration
number and manufacturer.
 Firm has manufacturing facilities for sterile infusion

(generic / me-too status) alongwith registration number, brand name and name of firm or
else submit drug product stability studies data as per checklist approved by Registration
Board in its 293rd meeting along with Form 5D and differentiall fee, within 6 months.
508. Name and address of manufacturer/ M/s Maple Pharmaceuticals (Pvt.) Ltd., Plot No. 147,
Applicant Sector 23, Korangi Industrial Area, Karachi.
Brand Name + Dosage Form + Strength HEMITHIN tablet
Composition Each film-coated tablet contains:
Prasugrel Hydrochloride………. 5 mg
Diary No. Date of R & I & fee Dy. No. 188 dated 19-07-2010, Rs. 8,000/- dated 19-
07-2010 (Photocopy),
Dy. No.912 dated 01-08-2016 Differential fee Rs.
12,000/- vide Challan No.0562235 dated 01-08-2016
(Photocopy)
Pharmacological Group Anti-platelet
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications
Pack size & Demanded Price As per PAC/PRC
Approval status of product in Reference MHRA approved
Me-too status Prasulet 5mg tablet of M/s Aspin Pharma, Karachi.
GMP status GMP certificate issued on 16-09-2021, bases on
evaluation conducted on 15-09-2021.
Remarks of the Evaluator (PEC-XVII)  Revise the label claim as per reference product that is,
Each film-coated tablet contains:
Prasugrel (as hydrochloride) ………. 5 mg
while the product is non-pharmacopoeial.
 Tablet Section (General) mentioned in GMP

Certificate No.42/2021-DRAP (K) dated 16-09-2021.

2021 & 13-07-2021.
Decision: Approved with Innovator’s specifications as per following label claim:

Each film coated tablet contains:
Prasugrel (as Hydrochloride) ……5mg
 The firm shall Submit fee of Rs. 30,000 for correction/pre-approval change in
composition (correction/change of salt form of the drug substance), as per
 Registration Board further decided to verify fee challans as per decision of 285 th
meeting.
Brand Name + Dosage Form + Strength HEMITHIN PLUS tablet
Prasugrel Hydrochloride………. 10 mg
Dy. No.912 dated 01-08-2016, Differential fee Rs.
12,000/- vide Challan No.0562239 dated 01-08-2016
(Photocopy)
“Duplicate dossier, R & I Verified”
Pharmacological Group Anti-platelet
Type of Form Form 5
Pack size & Demanded Price As per PAC/PRC
Me-too status Prasulet 10mg tablet of M/s Aspin Pharma, Karachi.
Remarks of the Evaluator (PEC-XVII)  Revise the label claim as per reference product that is,
Prasugrel (as hydrochloride) ………. 10 mg

2021 & 13-07-2021.
Decision: Approved with Innovator’s specifications and revised label claim as:
Prasugrel (as Hydrochloride) ……10mg
 The firm shall Submit fee of Rs. 30,000 for correction/pre-approval change in
composition (correction/change of salt form of the drug substance), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Registration Board further decided to verify fee challans as per decision of 285 th meeting
of Registration Board.
Brand Name + Dosage Form + Strength LIPOTRIM-N Tablet
Atorvastatin Calcium….10mg
Niacin….500mg
Diary No. Date of R & I & fee Dy. No. 43 dated 05-07-2010, Rs. 8,000/- (Photocopy),
Dy. No. 912 dated 01-08-2016 Differential fee Rs.
12,000/- vide Challan No.0562230 (Photocopy),
(Duplicate dossier, R & I verified)
Pharmacological Group HMG-CoA reductase inhibitor + Vitamin B3
Type of Form Form 5
adopted by Registration Board in its 275th meeting.
 Provide evidence of drug with same composition

already registered by DRAP (Me-too/generic) along
with proprietary/brand name, registration number and
manufacturer.
which were declared/approved by the Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength LOOPLITE 10mg Tablet
Torasemide …...10mg
Diary No. Date of R & I & fee Dy. No. 71 dated 11-08-2010, Rs. 8,000/- (Photocopy),
Pharmacological Group Loop diuretics
Type of Form Form 5
Approval status of product in Reference USFDA approved
Remarks of the Evaluator (PEC-XVII)  Provide evidence of drug with same composition
manufacturer.
while official monograph available in USP.
 In MHRA uncoated tablet, while in FDA film-coated
tablet available.
2021 & 13-07-2021.
alongwith registration number, brand name and name of firm or else submit application
on Form 5D along with stability studies data as per checklist of 293rd meeting of DRB, in
light of the Notification No. 320-DRB/ 2022(PE&R) dated 17th October 2022.
 Revision of specifications as per official monograph along with fee as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 for product specifications revision.
Brand Name + Dosage Form + Strength LOOPLITE 20mg Tablet
Torasemide …...20mg
Diary No. Date of R & I & fee Dy. No. 70 dated 11-08-2010, Rs. 8,000/- dated 11-08-
2010 (Photocopy)
(Duplicate dossier, R & I verified”
Pharmacological Group Loop diuretics
Type of Form Form 5
 Provide evidence of drug with same composition
manufacturer.
while official monograph available in USP.
 In MHRA uncoated tablet, while in FDA film-coated
tablet available.
2021 & 13-07-2021.
alongwith registration number, brand name and name of firm or else submit drug product
stability studies data as per checklist approved by Registration Board in its 293 rd meeting
along with Form 5D and differentiall fee, within 6 months. .
 Revision of specifications as per official monograph alongwith fee as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 for product specifications revision.
Brand Name + Dosage Form + Strength NOXAM 4mg tablet
Lornoxicam …...4mg (Dispersible tablet)
Diary No. Date of R & I & fee Dy.No. 17 dated 01-12-2010, Rs. 15,000/-
(Photocopy),
Dy. No. dated 27-10-2016 Differential fee Rs.
12,000/- dated 24-10-2016 (Photocopy),
Pharmacological Group NSAID
Approval status of product in Reference Xefo 4 mg - film-coated tablets (Takeda), AGES
Regulatory Authorities (Austria)
Me-too status Nicam 4mg film-coated tablet of M/s
S.J & G Fazul Ellahie, Karachi. Reg.No. 061603
Remarks of the Evaluator (PEC-XVII)  Fee challan for differential fee submission in the year
2016 is required.
 In the cover letter of initial submission dated 01-12-

2010, the product name mentioned as “Noxam
Dispersible tablet”, while in application form (Form-
5), the product name given is “Noxam tablet.
Clarification is required regarding applied formulation.
 In the label claim, the product is mentioned as both

film-coated & Dispersible tablet, while in formulation
provided is for film-coated tablet. Clarification is
required regarding applied formulation.


 Clarification regarding applied formulation is required since in the cover letter of initial
submission, “Noxam Dispersbile tablet” mentioned, while the label claim provided as film-
coated and dispersible tablet. Moreover, formulation given is for film-coated tablet.
 Submission of differential fee challan copy.
Brand Name + Dosage Form + Strength NOXAM Rapid 8mg tablet
Lornoxicam …...8mg (Dispersible tablet)
Diary No. Date of R & I & fee Dy. No. 16 dated 01-10-2010, Rs. 15,000/-, dated 24-
11-2010 (Challan Photocopy),
12,000/- dated 24-10-2016 (Photocopy),
Approval status of product in Reference Xefo Rapid 8mg - film-coated tablets (Takeda), AGES
Me-too status Retanox 8mg film-coated tablet
Arreta Pharmaceuticals (Pvt) Ltd. Rawalpindi.
 Fee challan for differential fee submission in the year
2016 is required.
 Initial submission verified by R & I Section.
 Resubmit application in prescribed format that is
Form-5.
 Provide evidence of already registered drug (Me-too)
for the applied formulation that is dispersible tablet.
 Provide evidence that the reference product is in the

form of dispersible tablet.

 Clarification regarding applied formulation since the label claim provided as film-coated
and dispersible tablet.
 Evidence of applied formulation/drug in dispersible tablet dosage form, already approved
by DRAP (generic / me-too status) alongwith registration number, brand name and name
of firm.
 Evidence of approval of applied formulation in dispersible tablet dosage form reference
regulatory authorities/agencies which were declared/approved by the Registration Board
in its 275th meeting.
 Submission of differential fee challan copy.
515. Name and address of manufacturer/ M/s Friends Pharma (Pvt) Ltd.31-Km, Ferozepur
Brand Name + Dosage Form + Strength CLOPAM-0.5mg tablet
Composition Each enteric-coated tablet contains:
Clonazepam …...0.5mg
Diary No. Date of R & I & fee Dy. No. 7931 dated 24-08-2010, Rs. 8,000/- challan
dated 18-08-2010 (Photocopy),
Differential fee Rs. 12,000/- vide challan No. 0574076
Pharmacological Group Benzodiazepine
Type of Form Form 5
Finished product Specification The firm has claimed in-house specifications.
Approval status of product in Reference KLONOPIN tablet 0.5mg (USFDA approved)
Me-too status Catier 0.5mg Tablet of M/s Medizan laboratories,
Islamabad. Registration No. 102750
 R & I verified.
 At annexure I, the environmental control processing

given is for sterile preparations. Please clarify?
 Tablet psychotropic section mentioned in the DML

renewal report.
 Revise label claim as per reference product as:
Each tablet contains:
Clonazepam……0.5mg
 Revise the finished drug product specifications as per
official monograph.
 Provide most recent GMP inspection report conducted

2021 & 13-07-2021.
Decision: Deferred for following points:
 Evidence of valid renewal of “Psychotropic tablet” section by Licensing Division.
 Revision of finished drug product specifications as per official monograph (USP).
 Revision of label claim as per reference product as follows:
Clonazepam…….0.5mg
 GMP compliance audit report conducted within last 03 years.
 Fee of Rs. 30,000/- for correction/pre-approval change/ in formulation in line with
reference product as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength CLOPAM-2 mg tablet
Clonazepam …...2mg
Pharmacological Group Benzodiazepine
Type of Form Form 5
Approval status of product in Reference KLONOPIN tablet 2mg (USFDA approved)
Me-too status Catier 2mg Tablet of M/s Medizan laboratories,
Remarks of the Evaluator (PEC-XVII)  R & I verified. Details incorporated in relevant column
above.

 Provide evidence of approval of Psychotropic section
by Licensing Division, DRAP Islamabad.
 Tablet psychotropic section mentioned in the DML

renewal report.
Clonazepam…...2mg
 Revise the finished drug product specifications as per
official monograph.

2021 & 13-07-2021.
 Evidence of valid renewal of “Psychotropic tablet” section by Licensing Division.
 Revision of label claim as per reference product as:
Clonazepam…….2mg
 Most recent GMP compliance audit report conducted within last 03 years.
 Fee of Rs. 30,000/- for correction/pre-approval change/ in formulation in line with
reference product as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength RABEZOLE 20 mg tablet
Rabeprazole sodium …...20mg
Pharmacological Group Proton pump inhibitor
Type of Form Form 5
Approval status of product in Reference ACIPHEX® (Rabeprazole Sodium)
Regulatory Authorities delayed-release enteric coated tablets
(USFDA approved)
Me-too status Evalep Tablet, 10mg enteric coated by Bryon pharma.
Reg. No. 052565
Remarks of the Evaluator (PEC-XVII)  R & I verified. Details incorporated in relevant column
above.

 The master formulation and manufacturing outlines are

not in accordance with the label claim, which is of
enteric coated tablets. Revise the master formulation
and manufacturing outlines accordingly.

2021 & 13-07-2021.
 Firm has claimed USP specifications while finished

product monograph is not available in USP or any
other pharmacopoeia. API monographs available in
USP and JP.
Decision: Approved with Innovator’s specifications. However, registration letter shall be
issued upon submission of following documents:
 Revised master formulation and manufacturing outlines in accordance with label
claim/composition (enteric coated tablets).
 GMP audit report conducted within last three years by QA&LT Division.
 Fee of Rs. 7,500/- for correction/pre-approval change/ in master formulation,
manufacturing outliens and drug product specifications as per notification No.F.7-11/2012-
B&A/DRAP dated 13-07-2021 alongwith verification of fee challans as per decision of 285th
meeting.
Brand Name + Dosage Form + Strength ARIZOLE 10mg tablet
Aripiprazole …...10mg
Pharmacological Group Dopamine partial agonist
Type of Form Form 5
Approval status of product in Reference ABILIFY® (aripiprazole) Tablets OTSUKA (USFDA
Regulatory Authorities approved with boxed warning)
Me-too status Ariscot 10mg Tablets of M/s Scotmann, Islamabad.
 R & I verified. Details incorporated in relevant column
above.
 Revise the label claim as per reference product as:
Aripiprazole …...10mg

2021 & 13-07-2021.
Decision: Approved with revised label claim as:

Aripiprzole…….10mg
 Registration letter shall be issued upon submission of fee of Rs. 30,000/- for correction/pre-
approval change/ in formulation in line with reference product as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021, verification of fee challans as per decision of 285th
meeting along with latest GMP inspection report conducted within last three years by
QA&LT Division.
Brand Name + Dosage Form + Strength BRAINAGOL-10mg tablet
Composition Each enteric coated tablet contains: -
Olanzapine….10mg
08-2010 challan dated 18-08-2010 (Photocopy),
Pharmacological Group Thienobenzodiazepine
Type of Form Form 5
Approval status of product in Reference MHRA approved both as un-coated and film-coated
Regulatory Authorities tablet. The brand “Zyprexa” tablet (US FDA approved)
for oral use. While in MHRA “Zyprexa” tablet are
mentioned as coated tablet.
Me-too status Oferta film-coated tablet 10mg of M/s AAA Health
Pharmaceutical Laboratories, Islamabad. Registration
No.101823
Remarks of the Evaluator (PEC-XVII)  Form-5 is not signed by the firm’s management.
Olanzapine…….10mg.
 Equipment list provided is for “sterile preparations”.

2021 & 13-07-2021.
 Tablet (General) section available as per DML renewal
Decision: Approved with USP specifiations and revised label claim as:
Olanzapine……10mg
QA&LT Division.
Brand Name + Dosage Form + Strength DOFARIN 40mg Injection
Composition Each 2ml contains: -
Drotaverine Hydrochloride….40mg
Pharmacological Group Anti-spasmodic
Type of Form Form 5
Approval status of product in Reference Three European countries Bulgaria, Romania, Hungary
Me-too status Drotamed Injection 40mg/2ml of M/s Medicraft
pharmaceuticals, Peshawar. Registration No. 098803
 The container mentioned is vial, while in reference
countries, the container is ampoule.
 Revise pharmacological group as “Papaverine &
derivatives”.
 The manufacturing outlines described for aseptic bulk
sterile filling in vials, while the applied formulation in
liquid injectable. Also fill volume given is 1ml. Please
clarify and revise accordingly.
 The equipment list provided is for cephalosporin
injection section.

2021 & 13-07-2021.
 Liquid injectable (General) section available as per
DML renewal inspection dated 08-03-2019.
QA&LT Division.
Brand Name + Dosage Form + Strength PEPRAZOLE-L 20mg Injection
Composition Each vial contains: -
Pantoprazole sodium equivalent to
Pantoprazole…….20mg
Type of Form Form 5
Approval status of product in Reference (US FDA approved) PROTONIX® I.V. (Pantoprazole
Regulatory Authorities sodium), For Injection: 40 mg of pantoprazole white to
off-white freeze-dried powder in a single-dose vial for
reconstitution.
Remarks of the Evaluator (PEC-XVII)  In the initial challan and cover letter of initial
submission, the product mentioned as Peprazole 20mg
injection.
 Revise the label claim as:
Each vial contains:
Pantoprazole sodium sesquihydrate lyophilized
powder eq. to pantoprazole………20mg
 Provide me-too/generic drug product already approved
by DRAP along with brand name, registration no and
manufacturer.
 At Annexure-F, equipment list given is for “Epofen
Injection.

 BP for monograph available as Pantoprazole for
Injection.
2021 & 13-07-2021.
 Dry powder lyophilized injectable (General) section
available as per DML renewal inspection dated 08-03-
2019.
Each vial contains:
Pantoprazole sodium sesquihydrate lyophilized powder eq. to pantoprazole………20mg
 GMP audit report conducted within last three years by QA&LT Division.
 Revision of drug product specifications as per official monograph.
 Submission of applicable fee for correction/pre-approval change/ in label
claim/composition as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
522. Name and address of manufacturer/ M/s Fredmann Pharmaceuticals, Pvt. Ltd. Plot No.
Applicant 82/83-B, Old Industrial Area, Mirpur Azad Kashmir.
Brand Name + Dosage Form + Strength BEP-LOW 50mg tablet
Losartan Potassium……...50mg
Dy. No. dated 21-10-2015, Differential fee Rs: 12000/-
dated 21-10-2015 vide deposit Slip No. 0525952
(Photocopy). R& I verified
Pharmacological Group Angiotensin II receptor antagonist
Type of Form Form 5
Finished product Specification Manufacturer Specifications
Approval status of product in Reference COZAAR® 25mg, 50mg, 100mg (Organon) US FDA
Regulatory Authorities approved with box warning as:
WARNING: FETAL TOXICITY
Me-too status Leupo 50mg tablet of M/s City pharmaceutical
laboratories, Karachi. Registration No.102997
GMP status Updated GMP compliance status required.
Remarks of the Evaluator (PEC-XVII)  Provide DRAP R & I cover letter copy of initial
submission of application in the year 2012.
Losartan potassium…….50mg
 Provide most recent/last GMP inspection report
official monograph available as per USP.

2021 & 13-07-2021.
Decision: Approved with USP specifications as per following label claim:
“Each film-coated tablet contains:
Losartan potassium…….50mg”
 Firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in product
specifications and dosage form from uncoated to film coated tablet, as per
notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021 along with latest GMP
inspection report conducted within last three years.
 Registration Board further decided to verify fee challan as per decision of 285th
523. Name and address of manufacturer/ Applicant:
Applicant M/s Maple Pharmaceuticals (Pvt.) Ltd., Plot No. 147,
Sector 23, Korangi Industrial Area, Karachi-74900.
Manufacturer:
PharmEvo (Pvt) Ltd. Plot No. A-29, North Western
Industrial Zone, Port Qasim, Karachi-75020.
Brand Name + Dosage Form + Strength TRIXOMAP 250mg Injection (IM)
Composition Ceftriaxone………. 250 mg
Diary No. Date of R & I & fee Dy. No. 49 dated 11-10-2010, Fee Rs. 8,000/- challan
Dy. No. dated 26-04-2016, Differential fee Rs.
“Duplicate dossier, R & I record could not be verified.
Type of Form Form 5
Pack size & Demanded Price 1’s, As per PAC/PRC
Me-too status Getofin 250mg IM injection Getz Pharma, Karachi.
GMP status GMP certificate issued to PharmEvo (Pvt) ltd. Karachi
on 17-09-2020, based on inspection conducted on 16-
09-2020.
Follow up routine GMP compliance inspection
conducted on 26-10-2021 with conclusion as:
“Overall, the firm is found operating at a satisfactory
level of GMP compliance”.
Remarks of the Evaluator (PEC-XVII)  Firm revised pharmacological group from
antibacterial to third-generation cephalosporins.
 Firm revised label claim as:
Each vial contains:
Ceftriaxone (as Sodium) …...250mg
 Sterile Dry Powder for Vial Section has been
confirmed by Licensing Division, DRAP Islamabad
vide letter No.F.2-1/98-Lic (Vol-II) dated 05-11-
2014.
 Firm submitted fee of Rs: 25,000/- vide online deposit

slip No.952250381 for above revision. However, firm
to submit an additional amount of Rs: 50,000/- being
contract manufacturing product. Full fee of
registration is required as per notifications7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021.
 GMP certificate issued on 16-09-2021 to Maple

pharmaceuticals, Karachi, based on evaluation
Decision: Registration Board noted the fact that two applications were submitted for
Ceftriaxone 250mg injection whereas R&I section verified only one application and
subsequently firm requested for considraton of Ceftriaxone 250mg injection for IV route of
administration only. Hence Registration Board rejected the instant application of
TRIXOMAP 250mg Injection (IM).
Manufacturer:
Brand Name + Dosage Form + Strength TRIXOMAP 250mg Injection (IV)
Diary No. Date of R & I & fee Dy. No. 49 dated 11-10-2010, Rs. 8,000/- Challan
12,000/- dated 16-03-2015 vide Challan No.0284842
(Photocopy),
dated 21-10-2015 vide challan No. 0296666,
dated 26-04-2016 vide challan No.0536995.
Type of Form Form 5
Me-too status Getofin 250mg IV injection Getz Pharma, Karachi.
09-2020.
antibacterial to third-generation cephalosporin.
Each vial contains:
2014.
slip No.0451778563 for above revision. However,
firm to submit an additional amount of Rs: 50,000/-
being contract manufacturing product. Full fee of
B&A/DRAP dated 07-05-2021 & 13-07-2021.

Each vial contains:
 Firm shall submit differential fee of Rs. 50,000 for correction/pre-approval change in
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Registration Board further authorized its Chairman for issuance of registration letter upon
capacity assessment of manufacturing and testing facility of M/s PharmEvo (Pvt) Ltd. Plot
No. A-29, North Western Industrial Zone, Port Qasim, Karachi.
Manufacturer:
Brand Name + Dosage Form + Strength TRIXOMAP 500mg Injection (IM)
2010 (Photocopy),
12,000/- dated 16-03-2015 vide Challan No.0284860
(Photocopy),
R & I record verified.
(Duplicate dossier” R & I diary no. needs confirmation
Type of Form Form 5
Me-too status Novaxone 500mg Injection IM of M/s NovaMed
Pharmaceuticals, Ferozepur Road Lahore. Registration
No. 100875
09-2020.
Each vial contains:
2014.

B&A/DRAP dated 07-05-2021 & 13-07-2021.

Each vial contains:
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
upon capacity assessment of manufacturing and testing facility of M/s PharmEvo (Pvt)
Ltd. Plot No. A-29, North Western Industrial Zone, Port Qasim, Karachi.
Manufacturer:
Brand Name + Dosage Form + Strength TRIXOMAP 500mg Injection (IV)
2010 (Photocopy),
Type of Form Form 5
Me-too status Cefrre 500mg IV Injection of M/s Arreta
Pharmaceuticals, Rawalpindi.Registration No. 099792
09-2020.
Each vial contains:
2014.

B&A/DRAP dated 07-05-2021 & 13-07-2021.

Each vial contains:
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Registration Board further decided to verify fee challans as per decision of 285th
Manufacturer:
Brand Name + Dosage Form + Strength TRIXOMAP 1gm Injection (IM)
Composition Ceftriaxone………. 1gm
2010 (Photocopy),
vide Challan No. 0520759 dated 11-04-2016
(Photocopy).
Type of Form Form 5
Me-too status Sweft Injection 1gm IM of M/s Avensis, Karachi.
09-2020.
Each vial contains:
Ceftriaxone (as Sodium) …...1gm
2014.

B&A/DRAP dated 07-05-2021 & 13-07-2021.

Each vial contains:
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Manufacturer:
Brand Name + Dosage Form + Strength TRIXOMAP 1gm Injection (IV)
Composition Ceftriaxone………. 1gm
2010 (Photocopy),
dated 11-04-2016 vide Challan No.0520758.
Type of Form Form 5
Me-too status Cefmark Injection 1gm IV of M/s Medimarker’s,
Hyderabad. Registration No. 100388
09-2020.
Each vial contains:
2014.
B&A/DRAP dated 07-05-2021 & 13-07-2021.


Each vial contains:
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Manufacturer:
Brand Name + Dosage Form + Strength FIXOMAP 400mg Capsule
Composition Cefixime………. 400mg
2010 (Photocopy),
dated 21-10-2015 vide Challan No. 0296653
Dy.No. dated 27-10-2016, Fee Rs: 30,000/- dated 24-
10-2016 vide challan No.0564275 dated 17-10-2016.
Type of Form Form 5
Approval status of product in Reference (US FDA Approved)
Me-too status Isocef 400mg capsule of M/s Shrooq Pharmaceuticals,
Lahore. Registration No. 040852
09-2020.
Cefixime (as trihydrate) ……... 400mg
 Firm revised finished drug product specifications as
approved in 313th meeting of Registration Board and
notified vide letter No. No.F.14-1l2022-PEC dated
14-03-2022.
 Capsule (Cephalosporin) Section has been confirmed

by Licensing Division, DRAP Islamabad vide letter
No.F.2-1/98-Lic (Vol-II) dated 05-11-2014 addressed
to the firm.

B&A/DRAP dated 07-05-2021 & 13-07-2021.

Cefixime (as trihydrate) ……... 400mg
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Manufacturer:
Brand Name + Dosage Form + Strength FIXOMAP Suspension
Composition Cefixime………. 100mg/5ml
2010 (Photocopy),
dated 21-10-2015 vide challan No. 0296659.
Type of Form Form 5
Pack size & Demanded Price 60ml, As per PAC/PRC
Me-too status Cefiget 100mg powder for oral suspension of M/s Getz
Pharmaceuticals, Karachi. Registration No. 045119.
09-2020.
Each 5ml of reconstituted suspension contains:
Cefixime (as trihydrate) ……… 100mg
 Oral Suspension Dry Powder (Cephalosporin) Section
has been confirmed by Licensing Division, DRAP
Islamabad vide letter No.F.2-1/98-Lic (Vol-II) dated
05-11-2014 addressed to the firm.

B&A/DRAP dated 07-05-2021 & 13-07-2021.

No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Manufacturer:
Brand Name + Dosage Form + Strength FIXOMAP DS Suspension
Composition Cefixime………. 200mg/5ml
2010 (Photocopy),
dated 01-08-2016 vide Challan No. 0562238
(Photocopy).
Type of Form Form 5
Pack size & Demanded Price 60ml, As per PAC/PRC
Me-too status Cefiget DS powder for suspension of M/s Getz
Pharmaceuticals, Karachi. Registration No. 045120
09-2020.
 Oral Suspension Dry Powder (Cephalosporin) Section
has been confirmed by Licensing Division, DRAP
Islamabad vide letter No.F.2-1/98-Lic (Vol-II) dated
05-11-2014 addressed to the firm.

B&A/DRAP dated 07-05-2021 & 13-07-2021.

No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
532. Name and address of manufacturer/ Zumars Pharma FTY. Pvt. Ltd. Plot No.02, Malir
Applicant Industrial Area, Malir, Karachi.
Brand Name + Dosage Form + Strength CLARIX 250mg Tablet
Clarithromycin………250mg
Diary No. Date of R & I & fee Dy. No. 328 dated 25-05-2011, Rs.8000/- dated 24-05-
2011, Challan dated 23-05-2011 (Photocopy)
Dy.No. dated 04-05-2016, Differential fee Rs.12000/-
dated 04-05-2016 vide Challan No.0539230 dated 03-
05-2016 (Photocopy).
Pharmacological Group Macrolide derivative/Antibiotic
Type of Form Form 5
Pack size & Demanded Price 1×10’s, as per PRC
Me-too status Clarifah 250mg Tablet of M/s Fahmir Pharma (Pvt)
Ltd. Sheikhupura. Registration No. 101543
Remarks of the Evaluator (PEC-XVII)  Provide most recent/last GMP compliance inspection
report conducted within last 03 years.
 R & I record verified.
Decision: Approved.
 Registration letter shall be issued upon submission of latest GMP inspection report
conducted within last three years.
 Registration Board further decided to verify fee challans as per decision of 285th meeting
Brand Name + Dosage Form + Strength CLARIX 500mg Tablet
Clarithromycin………500mg
Diary No. Date of R & I & fee Dy. No. 329 dated 25-05-2011
Rs.8000/- dated 24-05-2011, Challan dated 23-05-
2011 (Photocopy)
dated 04-05-2016 vide Challan No.0539229 dated 03-
05-2016 (Photocopy).
Pharmacological Group Macrolide derivative/Antibiotic
Type of Form Form 5
Pack size & Demanded Price 1×10’s, As per PRC
Me-too status Clarifah 500mg Tablet of M/s Fahmir Pharma (Pvt)
Ltd. Sheikhupura. Registration No. 101544
Decision: Approved.
conducted within last three years by QA&LT Division.
Brand Name + Dosage Form + Strength MONTEKAST 10mg Tablet
Montelukast Sodium eq. to Montelukast………10mg
2011 (Photocopy)
dated 04-05-2016 vide Challan No.0539248
(Photocopy).
Pharmacological Group Cyclopropane acetic acid derivative, Anti-asthmatic,
Leukotriene receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 1×10’s, 1×14’s, as per PRC
Approval status of product in Reference Montelukast 10mg (as Montelukast Sodium) Film-
Regulatory Authorities coated tablets, MHRA approved.
Me-too status Dowkast 10mg tablet of M/s Seatle (Pvt) Ltd. Lahore
 Provide finished drug product specifications as per

official monograph.

2021 & 13-07-2021.
Decision: Approved.
conducted within last three years by QA&LT Division alongwith fee of Rs. 7,500 for
correction/pre-approval change/ in product specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength COARTUM DS Tablet
Artemether………40mg
Lumefantrine…….240mg
2011 (Photocopy)
(Photocopy).
“Duplicate Dossier, R & I verified for Coartom tablet”
Pharmacological Group Antimalarial/ antiprotozoal drug
Type of Form Form 5
Approval status of product in Reference Prequalified by WHO
Me-too status Winterm 40mg/240mg tablet of M/s Winthrox
laboratories, Karachi. Registration No. 100493
 Form-5 is not signed by the firm’s management.
 The initial and differential fee challans submitted for
“Coartom tablet” while duplicate dossier provided is for
“Coartum DS tablet”.
 The label claim is of “un-coated” tablet, while master

formulation and manufacturing out-lines submitted for
film-coated tablet. Please clarify and revise accordingly.
 Revise finished drug product specifications as per

official monograph (International pharmacopoeia).

 Provide most recent/last GMP compliance inspection

 Verification of R & I record of initial submission of

application required.

2021 & 13-07-2021.
 Clarification regarding applied strength is required from the firm since, as per R & I
record, cover letter of initial submission of registration application, initial fee challan and
differential fee challan copies submitted, the product applied is “Coartom tablet”, while in
the duplicate Form-5 submitted by the firm, the product applied is “Coartum DS tablet”.
 Revision of master formulation and manufacturing outlines as per label claim.
 Revision of finished drug product specifications as per official monograph (International
pharmacopoeia).
Brand Name + Dosage Form + Strength ZURAFENAC SR Tablet
Composition Each sustained release film-coated tablet contains:
Diclofenac Sodium……100mg
2011 (Photocopy),
(Photocopy).
Pharmacological Group Anti-rheumatics, Systemics (NSAID)
Type of Form Form 5
Pack size & Demanded Price 2×10’s, 3×10’s, As per PRC
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 Ajdiclof-SR Tablet 100mg of AJM pharma, Karachi.
Remarks of the Evaluator (PEC-XVII)  Specify/mention the finished drug product
specifications as per official monograph.


2021 & 13-07-2021.
conducted within last three years alongwith fee of Rs. 7,500 for correction/pre-approval
change/ in product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021.
Brand Name + Dosage Form + Strength ZUMAFLAM-P 75mg Tablet
Composition Each sugar-coated tablet contains:
Diclofenac Potassium……75mg
2011 (Photocopy),
(Photocopy).
Pharmacological Group Anti-rheumatics, Systemics (NSAID)
Type of Form Form 5
Remarks of the Evaluator (PEC-XVII)  Form-5 is not signed by the firm’s management.

reference regulatory authorities / agencies which were
 Provide me-too/generic drug product for the applied
formulation (brand name, registration number and firm
name).
 .R & I record verified.

Decision: In order to dispose of new applications of Diclofenac Potassium 75mg tablet, the
Board requested Pharmacy Services Divison to intimate PE&R Division regarding provision
of safety and efficacy studies approved bv any credible sources and shared by manufcaturers
and if no such studies are available than PMA will conduct safety and efficacy trials as per
Bio study rules, 2017, as decided by Appellate Board in 162nd meeting.
Brand Name + Dosage Form + Strength ZUTEC 150mg Tablet
Ranitidine as HCl……150mg
2011 (Photocopy),
(Photocopy).
Pharmacological Group Anti-peptic ulcerants
Type of Form Form 5
Me-too status Ck-Ran Tablet 150mg of M/s CKD Pharmaceuticals,
Remarks of the Evaluator (PEC-XVII)  Revise pharmacological group as “H2-receptor
antagonists”.
 Form-5 is not signed by the firm’s management.

2021 & 13-07-2021.
Brand Name + Dosage Form + Strength GAVERAL 20mg Capsule
Composition Each Capsule contains:
Enteric coated pellets of Omeprazole……20mg
Diary No. Date of R & I & fee Dy. No. 341 dated 25-05-2011 Rs.8000/- dated 24-05-
2011, Challan dated 23-05-2011 (Photocopy),
(Photocopy).
(Duplicate Dossier) R& verified
Type of Form Form 5
Approval status of product in Reference US FDA approved
Me-too status Parkoprazole Capsule 40mg of M/s Parkar Pharma,
Kotri. Registration No. 102817.
 Revise pharmacological group as “Proton pump
inhibitor”.
 Revise manufacturing outlines in accordance with the

formulation applied that is for “ready to fill pellets”.

 Revise label claim as:
Each Capsule contains:
Omeprazole enteric coated pellets eq to omeprazole
………20mg.
 Specify pellets source (manufacturer) and provide
CoA of omeprazole pellets, valid GMP certificate of
pellets manufacturer, stability data of 03 batches of
omeprazole pellets.

2021 & 13-07-2021.
Omeprazole enteric coated pellets eq to omeprazole ………20mg.
 Firm shall submit documents for pellets source, CoA, stability study data of three
batches of pellets and GMP certificate of pellets manufacturer and fee (if import)
along with fee of Rs. 7,500 for variation in registration application i.e.,
correction/change of manufacturing outlines, pharmacological group to “Proton
pump inhibitor” as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength GAVERAL 40mg Capsule
Enteric coated pellets of Omeprazole……40mg
(Photocopy).
Type of Form Form 5
Me-too status Parkoprazole Capsule 40mg of M/s Parkar Pharma,
Kotri. Registration No. 102818
Remarks of the Evaluator (PEC-XVII)  Provide most recent GMP inspection report conducted
Omeprazole enteric coated pellets eq to omeprazole
………40mg
CoA of omeprazole pellets, valid GMP certificate of
pellets manufacturer, stability data of 03 batches of
omeprazole pellets.

2021 & 13-07-2021.

Omeprazole enteric coated pellets eq. to Omeprazole ………40mg
Registration letter shall be issued upon submission of following:
 Source of omeprazole pellets, stability study data of 03 batches of omeprazole pellets, CoA,
valid GMP certificate of pellets manufacturer.
 Latest GMP inspection report conducted within last three years along with applicable fee
for pellets source fixation (in case of import) as per notification No.F.7-11/2012-
 Registration board further decided to verify fee challans as per decision of 285th meeting.
Brand Name + Dosage Form + Strength ESOMEZOLE 20mg Capsule
Enteric coated pellets of Esomeprazole (as
Esomeprazole magnesium trihydrate) ……20mg
(Photocopy).
Type of Form Form 5
Me-too status Parko-Eprazole Capsule 20mg of M/s Parkar Pharma,
 Revise pharmacological group as “Proton pump
inhibitor”.
 Provide evidence of approval of relevant section by

Esomeprazole (as Magnesium trihydrate enteric
coated pellets) ………20mg
CoA of Esomeprazole pellets, valid GMP certificate
of pellets manufacturer, stability data of 03 batches of
omeprazole pellets.

2021 & 13-07-2021.

Esomeprazole (as Magnesium trihydrate enteric coated pellets) ………20mg
 Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2012-
 Registration board further decided to verify fee challans as per decision of 285th meeting.
Brand Name + Dosage Form + Strength ESOMEZOLE 40mg Capsule
Enteric coated pellets of Esomeprazole (as
Esomeprazole magnesium trihydrate) ……40mg
(Photocopy).
Type of Form Form 5
Me-too status Parko-Eprazole Capsule 40mg of M/s Parkar Pharma,

Esomeprazole (as Magnesium trihydrate enteric
coated pellets) ………40mg
CoA of Esomeprazole pellets, valid GMP certificate
of pellets manufacturer, stability data of 03 batches of
omeprazole pellets.
R & I record verified.

2021 & 13-07-2021.
Esomeprazole (as Magnesium trihydrate enteric coated pellets) ………40mg
 Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-11/2012-
 Registration Board further decided to verify fee challans as per decision of 285th meeting.
Brand Name + Dosage Form + Strength ZUEFIX 400mg Capsule
Cefixime……400mg
(Photocopy).
Pharmacological Group Anti-biotic/Cephalosporin (3rd generation)
Type of Form Form 5
Pack size & Demanded Price 5’s, As per PRC
Me-too status Isocef 400mg capsule of M/s Shrooq Pharmaceuticals,
Cefixime (as trihydrate) ……400mg
 Revised finished drug product specifications as

approved in 313th meeting of Registration Board and
notified vide letter No. No.F.14-1l2022-PEC dated
14-03-2022.

2021 & 13-07-2021.
Cefixime (as trihydrate) ……400mg
 Registration letter will be issued upon submission of latest GMP inspection report
conducted within last three years along with fee of Rs. 30,000 for correction/pre-approval
change in composition (correction/change of salt form of the drug substance), as per
Brand Name + Dosage Form + Strength ZUEFIX Dry Suspension (100mg/5ml)
Composition Each 5ml suspension contains:
Cefixime……100mg
(Photocopy).
Type of Form Form 5
Pack size & Demanded Price 30ml, As per PRC
Me-too status Cefiget 100mg powder for oral suspension of M/s Getz
Pharmaceuticals, Karachi. Registration No. 045119.

2021 & 13-07-2021.
Brand Name + Dosage Form + Strength ZUEFIX DS Dry Suspension (200mg/5ml)
Cefixime……200mg
(Photocopy).
Type of Form Form 5
Me-too status Cefiget DS powder for suspension of M/s Getz

2021 & 13-07-2021.
Brand Name + Dosage Form + Strength ZURCEF 250mg Capsule
Cephradine……250mg
(Photocopy).
Pharmacological Group Anti-biotic/Cephalosporin (1st generation)
Type of Form Form 5
Approval status of product in Reference Cefradine 250mg Capsules (MHRA approved)
Me-too status Dicef 250 mg Capsule by M/s ICI Pharma (#043849)

Cephradine (anhydrous)……...250mg
2021 & 13-07-2021.
Brand Name + Dosage Form + Strength ZURCEF 500mg Capsule
Diary No. Date of R & I & fee Dy. No., 344 dated 25-05-2011 Rs.8000/- dated 24-05-
(Photocopy).
Type of Form Form 5
Me-too status Retacef 500mg Capsule of M/s Arreta
Pharmaceuticals, Rawalpindi. Registration No. 102738
2021 & 13-07-2021.
Brand Name + Dosage Form + Strength ZURCEF Dry Suspension 125mg/5ml
(Photocopy).
Type of Form Form 5
Approval status of product in Reference (US FDA approved with status discontinued)
Me-too status Retacef 125mg/5ml Dry Suspensionof M/s Arreta
Pharmaceuticals, Rawalpindi. Registration No. 102728

adopted by the Registration Board in its 275th meeting
as the approval status in USFDA is discontinued.
Each 5ml suspension contains:
Cephradine (anhydrous)……125mg
2021 & 13-07-2021.
Decision: Deferred for evidence approval of applied formulation in reference regulatory
authorities which were declared/adopted by the Drug Registration Board in its 275th meeting
as the approval status in USFDA is discontinued.
Brand Name + Dosage Form + Strength ZURCEF Dry Suspension 250mg/5ml
(Photocopy).
Type of Form Form 5
Approval status of product in Reference Cefradine powder for Syrup 250mg/5ml
Regulatory Authorities (MHRA approved)
Me-too status Retacef 250mg/5ml Dry Suspension of M/s Arreta
Pharmaceuticals, Rawalpindi. Registration No.
102727.
2021 & 13-07-2021.
Brand Name + Dosage Form + Strength ZACTRUM Suspension
Trimethoprim……40mg
Sulphamethoxazole……200mg
(Photocopy).
Pharmacological Group Anti-biotic/Sulfonamide derivative (Co-trimoxazole)
Type of Form Form 5
Pack size & Demanded Price 50ml,400ml, As per PRC
Approval status of product in Reference Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric
Regulatory Authorities Suspension (MHRA approved)
Me-too status Radisulf Oral Suspension of M/s Radiant Pharma,
Remarks of the Evaluator (PEC-XVII)  Provide most recent GMP inspection report.
Decision: Approved. Registration letter will be issued upon submission of latest GMP
inspection report conducted within last three years.
Brand Name + Dosage Form + Strength HYDRIN Syrup
Composition Each 5ml syrup contains:
Aminophylline…….32mg
Diphenhydramine HCl….8mg
Ammonium chloride……30mg
Menthol………...1mg
(Photocopy).
Pharmacological Group Expectorant/antihistamine
Type of Form Form 5
Pack size & Demanded Price 120ml,450ml, As per PRC
Me-too status Hydryllin Syrup, M/s Searle, Reg. No. 000016
Each 5ml syrup contains:
Aminophylline…….32mg
Diphenhydramine HCl….8mg
Ammonium chloride……30mg
Menthol………....0.98mg


 Provide evidence of me-too/generic drug product

already approved by DRAP, with brand name,
registration number and manufacturer.

alongwith registration number, brand name and name of firm as quantity of menthol in
applied formulation is different.
Brand Name + Dosage Form + Strength VITAPLEX Syrup
Composition Each 15ml syrup contains:
Thiamine HCl……3 mg
Riboflavin Phosphate…3 mg
Pyridoxine HCl….2 mg
Nicotinamide…23 mg
(Photocopy).
Pharmacological Group Vitamins (Vitamin B complex)
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml,450ml, As per PRC
Me-too status Liskoplex Syrup (Thiamine HCl 3mg, Riboflavin 3mg,
Pyridoxine HCl 2mg, Nicotinamide 23mg) of M/s
Lisko Pakistan (Pvt) Ltd. Karachi. Registration No.
003953

“Each 15ml syrup contains:
Thiamine HCl …… 3 mg
Riboflavin …… 3 mg
Pyridoxine HCl …... 2 mg
Nicotinamide …… 23 mg”
Registration letter will be issued upon submission of following:

 Submission of fee of Rs. 30,000/- for correction/pre-approval change in salt form of
Riboflavin as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
 Verification of fee challans as per decision of 285th meeting of Registration Board.
553. Name and address of manufacturer/ M/s Helix Pharma (Pvt.) Ltd., Hakimsons House, A/56,
Applicant S.I.T.E Manghopir Road, Karachi.
Brand Name + Dosage Form + Strength VALSAR-DUE 80/12.5mg tablet
Valsartan…………...80 mg
Hydrochlorothiazide…….12.5mg
Diary No. Date of R & I & fee Dy. No. 1369 dated 09-08-2012, Rs. 8,000/- dated
Challan dated 25-07-2012 (Photocopy),
12,000/- vide challan No. 0514604 dated 07-12-2015
(Photocopy),
(Duplicate dossier), R&I verified
Pharmacological Group Hypertensive, Congestive heart failure
Type of Form Form 5
Pack size & Demanded Price 10’s, 14’s, As per P.R.C
Approval status of product in Reference (MHRA approved) Co-Diovan® 80/12.5 mg film-
Regulatory Authorities coated tablets
Me-too status Valhydro-H 80+12.5 Tablet of Ciba pharmaceuticals,
GMP status GMP certificate was issued based on inspection
conducted on 29 October 2020.
 Revise the pharmacological group as “Angiotensin II
receptor blockers (ARBs) and diuretics”.
2021 & 13-07-2021.
Decision: Approved. Firm shall submit revised pharmacological group as “Angiotensin II
receptor blockers (ARBs) and diuretics” along with fee of Rs. 7,500/- for pre-approval
change/correction of pharmacological group as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021, before issuance of registration letter.
Brand Name + Dosage Form + Strength VALSAR-DUE 160/12.5mg tablet
(Photocopy),
(Duplicate dossier) R&I verified
Type of Form Form 5
Approval status of product in Reference (MHRA approved) Co-Diovan® 160/12.5 mg film-
Me-too status Hc-Valdil Tablet 160/12.5 of AJM Pharma, Karachi.
GMP status GMP certificate was issued based on inspection
conducted on 29 October 2020.
Remarks of the Evaluator (PEC-XVII)  Revise the pharmacological group as “Angiotensin II
2021 & 13-07-2021.
Brand Name + Dosage Form + Strength VALSAR-DUE 160/25mg tablet
Hydrochlorothiazide…….25mg
(Photocopy),
(Duplicate dossier),R&I verified
Type of Form Form 5
Approval status of product in Reference (MHRA approved) Co-Diovan® 160/25 mg film-
Me-too status Hc-Valdil Tablet 160/25 of AJM Pharma, Karachi.
GMP status Updated GMP compliance status is required
 Revise the pharmacological group as “Angiotensin II
2021 & 13-07-2021.
556. Name and address of manufacturer/ M/s Panacea Pharmaceuticals Plot No.4, Street No. S-
Applicant 6, National Industrial Zone, Rawat, Islamabad.
Brand Name + Dosage Form + Strength TALIMUS OINTMENT 0.03%
Tacrolimus monohydrate equivalent to
tacrolimus….0.3mg
05-2011 (Challan copy not provided)
Differential fee Rs. 12,000/- vide challan No.0536652
dated 28-10-2015 (Photocopy)
(Duplicate dossier, R & I verified vide Assist.Director
(Reg-II) letter No.F.1-11/2019-Reg-II dated 02-07-
2020)
Pharmacological Group Agents for dermatitis, excluding corticosteroids, atopic
dermatitis
Type of Form Form 5
Approval status of product in Reference (MHRA approved) Tacrolimus 0.03% Ointment
Me-too status Cromata Ointment 0.03% w/w of M/s Pakistan
Pharmaceutical Products (Pvt) Ltd. Karachi.
GMP status DML renewal inspection conducted on 01-12-2020 and
the panel recommended DML renewal of the firm.
Remarks of the Evaluator (PEC-XVII)  Provide initial fee challan copy for the applied product.
 Firm revised pharmacological group as “Agents for
dermatitis, excluding corticosteroids”.
2021 & 13-07-2021.l
 The firm has Cream/Ointment Section (General) as per
DML renewal inspection conducted on 01-12-2020,
wherein DML renewal recommended by the Panel.
Decision: Approved.
 Registration letter shall be issued upon submission latest GMP inspection report conducted
within last three years., valid within last three years alongwith fee of Rs. 7,500 for variation
in registration application i.e., correction/change of pharmacological group, as per
Brand Name + Dosage Form + Strength HYRON Lotion 3%
Hydroquinone…….30mg
12,000/- vide challan No. 0536654 (Photocopy),
(Duplicate dossier, R & I verified vide Assist.Director
2020)
Pharmacological Group Other dermatologicals
Type of Form Form 5
 Provide initial fee challan copy for the applied product.
Firm provided Eukroma by Leo Pharma, Uk, which
couldn’t be verified.
 Provide me-too/generic drug product approved by
DRAP, along with brand name, registration name and
manufacturer name. firm provided Melex 3% lotion of
Saia pharmaceuticals, Karachi, which could not be
verified.
 Evidence of approval of required manufacturing
facilities by Licensing Division.
•Evidence of approval of applied formulation in reference regulatory authorities/agencies
•Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm as quantity of menthol in
applied formulation is different.
Brand Name + Dosage Form + Strength HYRON PLUS CREAM
Hydroquinone…….40mg
Glycolic acid………80mg
05-2011, Challan dated 27-05-2011 (Photocopy)
Dy. No. dated, Differential fee Rs. /- vide challan No.
dated (Photocopy),
(Duplicate dossier, only initial submission verified
form R & I vide Assist.Director (Reg-II) letter No.F.1-
11/2019-Reg-II dated 02-07-2020. Verification of
initial and differential fee challans required)
Pharmacological Group Other dermatologicals
Type of Form Form 5
Me-too status Clariderm-Plus Each gm contains: - Hydroquinone ....
4% w/w, Glycolic Acid .... 8% w/w of M/s Steifel
laboratories (Pvt.) Ltd. Registration No. 037851
Remarks of the Evaluator (PEC-XVII)  Provide evidence of differential fee submission since
firm has provided differential fee challan No.0536661
of Metro gel.
 Clarification regarding label claim is required as the
applied formulation is cream, while the label claim
given in “ml”.
•Evidence of approval of applied formulation in reference regulatory authorities/agencies
•Evidence of differential fee submission as differential fee challan No.0536661 submitted is
for “Metro gel”.
 Clarification regarding label claim as the applied formulation is cream, while label claim
given in “ml”.
Brand Name + Dosage Form + Strength ISOTOP PLUS GEL
Isotretinoin…….0.5mg
Erythromycin………20mg
dated,
(Duplicate dossier, R & I verified vide Assist. Director
2020)
Pharmacological Group Retinoid for the treatment of acne, Anti-acne
Type of Form Form 5
Me-too status Tretocin Gel (Erythromycin …...20mg, Isotretinoin
…... 0.50mg) of M/s Dermo tech Pakistan, Lahore.
Remarks of the Evaluator (PEC-XVII)  Provide initial fee challan copy for the applied product.
 Provide evidence of differential fee submission as the
Firm has provided differential fee challan No.0536661
for Metro gel.
275th meeting.
 Evidence of differential fee submission as differential fee challan No.0536661
submitted is for “Metro gel”.
Brand Name + Dosage Form + Strength DIMOL EYE DROPS
Composition Each ml of ophthalmic solution contains:
Timolol maleate equivalent to Timolol…….5mg
Dorzolamide HCl eq to Dorzolamide………20mg
Diary No. Date of R & I & fee Dy. No. 41 dated 24-05-2011, Rs. 8,000/- (Challan
copy not provided)
Dy. No. dated, Differential fee Rs. 12,000/- vide
challan No.0536670 dated 30-10-2015. (Challan
Photocopy),
2020)
Pharmacological Group Carbonic anhydrate inhibitors, beta blocking agent,
anti-glaucoma preparations and miotics
Type of Form Form 5
Approval status of product in Reference USFDA approved (COSOPT® (Dorzolamide
Regulatory Authorities hydrochloride and timolol maleate ophthalmic
solution) containing Dorzolamide 20 mg/ml (2%)
and timolol 5 mg/ml (0.5%).
Me-too status SyniGan Ophthalmic Solution of M/s Barrett Hodgson,
Pakistan, Karachi. Registration No. 055532
Remarks of the Evaluator (PEC-XVII)  The firm has Sterile Ophthalmic (General) Section as
per DML renewal inspection conducted on 01-12-
2020, wherein DML renewal recommended by the
Panel.
meeting.
Brand Name + Dosage Form + Strength FLORIP EYE DROPS 0.1%
Composition Each ml ophthalmic suspension contains:
Fluorometholone………….1mg
2011(Fee Challan copy not provided),
12,000/- vide challan No.0536666 dated 28-10-2015.
(Photocopy),
2020)
Pharmacological Group Corticosteroids, plain, anti-inflammatory agents
Type of Form Form 5
Approval status of product in Reference USFDA approved FML® (fluorometholone
Regulatory Authorities ophthalmic suspension, USP) 0.1% is a sterile, topical
anti-inflammatory agent for ophthalmic use.
Me-too status Flouramet Ophthalmic Suspension of M/s Pharmasol
Pvt ltd. Lahore. Registration No. 090431
 The firm has Sterile Ophthalmic (General) Section as
per DML renewal inspection conducted on 01-12-
2020, wherein DML renewal recommended by the
Panel.
Decision: Approved. Registration Board further decided to verify fee challans as per decision
of 285th meeting.
Brand Name + Dosage Form + Strength SILON SHAMPOO 2.5%
Selenium Sulfide………….25mg
06-2011. (Fee challan copy dated 03-06-2011provided)
dated.
2020)
Pharmacological Group Other antifungals for topical use
Type of Form Form 5
Approval status of product in Reference (MHRA approved) Selsun Lotion/Shampoo 2.5% Each
Regulatory Authorities 100 ml of suspension contains 2.5 g of Selenium
Sulphide Ph. Eur.
Me-too status SELSUN SUSPENSION of M/s Abbott Pakistan,
Remarks of the Evaluator (PEC-XVII)  Provide evidence of differential fee submission
(DRAP R & I stamped cover letter copy of differential
fee submission and differential fee challan).
 USP monograph available as: Selenium Sulfide
Topical Suspension is an aqueous, stabilized
suspension of Selenium Sulfide. It contains not less
than 90.0 percent and not more than 110.0 percent of
the labeled amount of SeS2. It contains suitable
buffering and dispersing agents.
[NOTE—Where labeled for use as a shampoo, it
contains a detergent. Where labeled for other uses, it
may contain a detergent.]
 Firm has provided letter No.F.1-67/2004-Lic dated 17-
06-2011 titled as “Grant of additional section –
approval thereof” having “Topical preparation”
section as evidence of availability of required
manufacturing facility for the applied formulation.
However, as per DML renewal report dated 01-12-
2020, the firm has following sections:
1. Tablet Section (General)
2. Capsule-I Section (General)
3. Capsule-II Section (General)
4. Tablet Section (Psychotropic)
5. Cream/Ointment Section (General)
6. Dry suspension Section (General)
7. Sachet Section (General)
8. Sterile Ophthalmic (Section)
9. Capsule (Ceph)
10. Dry powder for suspension (Ceph).
 Evidence of approval of requisite manufacturing facilitiy by Licensig Division.
 Evidence of differential fee submission (statistical officer signed/stamped cover
letter, fee challan).
563. Name and address of manufacturer/ M/s WnsFeild Pharmaceuticals, Plot No.122, Block-A,
Applicant Phase-V, Industrial Estate Hattar.
Brand Name + Dosage Form + Strength MOOD 200mg tablet
Composition Each film-coated extended-release tablet contains: -
Carbamazepine…...200mg
01-2011 (Challan copy not provided),
Differential fee Rs. 12,000/- dated 14-10-2015 vide
challan No. 0501571 dated 13-10-2015.
Pharmacological Group Anticonvulsants
Type of Form Form 5
Approval status of product in Reference TEGRETOL-XR extended release 100,200,400mg
Regulatory Authorities tablet (USFDA approved)
Me-too status Epitab XR Tablets 200mg of M/s Werrick
pharmaceuticals, Islamabad. Reg. No. 031872
Remarks of the Evaluator (PEC-XVII)  Form-5 not signed by firm management.
 Provide challan copy of initial fee submission.
 The firm has revised label claim in duplicate dossier as
“film-coated extended-release tablet” in duplicate
dossier since in the cover letters of initial submission
and differential fee submission, the firm has not
mentioned extended-release tablet. The firm shall
therefore submit applicable fee as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-
2021 for pre-registration variation.
Decision: Approved.
 Registration letter shall be issued upon submission of fee of Rs. 30,000 for
correction/pre-approval change in composition (correction/change of formulation
from film-coated tablet to film coated extended-release tablet), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021 alongwith latest GMP inspection
report conducted within last three years.
meeting.
Brand Name + Dosage Form + Strength MOOD 400mg tablet
Composition Each film-coated extended-release tablet contains: -
Carbamazepine…...400mg
01-2011 (Challan copy not provided).
challan No. 0501570.
Pharmacological Group Anticonvulsants
Type of Form Form 5
Approval status of product in Reference TEGRETOL-XR extended release 100,200,400mg
Me-too status Epitab XR Tablets 400mg of M/s Werrick
pharmaceuticals, Islamabad. Reg. No. 031873
 Provide fee challan copy of initial fee submission.
 The firm has revised label claim in duplicate dossier as
“film-coated extended-release tablet” in duplicate
dossier since in the cover letters of initial submission
and differential fee submission, the firm has not
mentioned extended-release tablet. The firm shall
therefore submit applicable fee as per notifications 7-
11/2012-B&A/DRAP dated 07-05-2021 & 13-07-
2021 for pre-registration variation.
Decision: Approved.
 Registration letter shall be issued upon submission fee of Rs. 30,000 for
correction/pre-approval change in composition (correction/change of formulation
from film-coated tablet to film coated extended-release tablet), as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021 alongwith latest GMP inspection
meeting.
Brand Name + Dosage Form + Strength WINSOTIL tablet
Composition Each un-coated tablet contains: -
Diphenoxylate Hydrochloride…. 2.5mg
Atropine Sulphate……….0.025mg
2011 (Challan copy not provided)
challan No.0548753.
Pharmacological Group Anti-diarrheral agents/ anti-spasmodic agents
Type of Form Form 5
Approval status of product in Reference Lomotil tablet, Pfizer (USFDA approved)
Regulatory Authorities Each Lomotil tablet contains:
2.5 mg of Diphenoxylate hydrochloride USP
(equivalent to 2.3 mg of diphenoxylate) and 0.025 mg
of Atropine sulfate USP (equivalent to 0.01 mg of
atropine)
Me-too status Atox 2.5mg/0.025mg Tablet MBL Pharma, Lasbela.
Reg. No. 081015
 . R & I record verified.
 Provide challan copy of initial fee submission.
Decision: Rejected since firm does not have approval from CLB for required manufacturing
facility of “Tablet (Psychotropic) section”.
Brand Name + Dosage Form + Strength MEBEWNS 200mg capsule
Composition Each modified-release capsule contains: -
Mebeverine HCl as extended-release pellets equivalent
to Mebeverine HCl ………200mg
11-2011 (Challan copy not provided).
challan No. dated
Pharmacological Group anti-spasmodic
Type of Form Form 5
Approval status of product in Reference MHRA approved (Aurobeverine MR 200 mg
Regulatory Authorities modified-release capsules, hard)
Me-too status Pasmolic MR Capsule 200mg of M/s The Searle
Company, Karachi. Reg. No. 103040
 . R & I record verified.
 Challan copies of initial and differential fee
submission not provided.
 As per master formulation/composition, Mebeverine
HCl as extended-release pellets (80%), form Vision
Pharmaceuticals are to be utilized. Provide CoA,
stability study data of pellets for three batches as per
Zone IV-A and GMP certificate of pellets
source/manufacturer.
Decision: Approved. Registration letter shall be issued upon submission pellets source, CoA,
stability study data of three batches of pellets and GMP certificate of pellets manufacturer
alongwith Latest GMP inspection report conducted within last three years.
meeting.
Brand Name + Dosage Form + Strength TAMOXI 20mg tablet
Composition Each film-coated tablet contains: -
Tamoxifen (As Citrate) ………...20mg
Diary No. Date of R & I & fee Dy. No. 287 dated 25-11-11, Rs. /- 8000/-
Dy. No. dated Differential fee Rs. 12,000/- vide
challan No. 0548767 dated 14-10-2015.
(Duplicate dossier, R & I record of initial and
differential fee submission along with fee challans
required) R&I verified
Pharmacological Group Selective estrogen-receptor modulator
Type of Form Form 5
Approval status of product in ReferenceUSFDA approved
Regulatory Authorities (NOLVADEX 10mg & 20mg, uncoated tablet)
**Federal Register determination that product was not
discontinued or withdrawn for safety or effectiveness
reasons**, Also MHRA approved
Me-too status Tamoxidex 20mg Tablet of Pacific pharma, Lahore.
Remarks of the Evaluator (PEC-XVII)  Revise label claim as per reference product as:
Tamoxifen (As Citrate) ………...20mg, along with
revision of master formulation and manufacturing
outlines accordingly.
2021 & 13-07-2021.
Tamoxifen (as Citrate) ………...20mg
 Firm shall submit fee of Rs. 7,500 for correction/pre-approval change in composition
(correction/change of formulation from film coated to uncoated tablet), as per
notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021 along with copy of latest
GMP inspection report conducted within last three years.
568. Name and address of manufacturer/ M/s Dyson Research Laboratories (Pvt.) Ltd., 28-Km,
Applicant Ferozepur Road, Lahore.
Brand Name + Dosage Form + Strength DYAVISTA 60mg tablet
Composition Each Film-coated tablet contains:
Raloxifene Hydrochloride……….60 mg
05-2011.
Dy. No. dated 21-06-2016 Differential fee Rs. 12,000/-
dated 21-06-2016 vide challan No. dated.
(Duplicate dossier, R & I verified”.
Pharmacological Group Anti-osteoporotic, Selective estrogen receptor
modulator
Type of Form Form 5
Approval status of product in Reference EVISTA® 60mg film-coated tablet
Regulatory Authorities (USFDA approved with Boxed Warning)
Warning: Increased Risk of Venous
Thromboembolism and Death from Stroke
Me-too status Roxista 60mg Tablets of M/s Genome
Pharmaceuticals, Hattar. Registration No. 084619
GMP status Updated GMP compliance status required
Remarks of the Evaluator (PEC-XVII)  Provide evidence of relevant section approval by
 Revise master formulation as per label claim, since
quantity of Raloxifene base is given. Moreover, film-
coating materials not mentioned in master formulation.
 Film-coating process not described in the
manufacturing outlines/flow chart.
2021 & 13-07-2021.
Decision: Approved.
 Registration letter shall be issued upon submission latest GMP inspection report
conducted within last three years alongwith fee of Rs. 7,500 for variation in
registration application i.e., correction/change of master formulation &
manufacturing outlines as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
Brand Name + Dosage Form + Strength DICLOSTOL tablet (75mg/200mcg)
Composition Each modified-release tablet contains:
Diclofenac Sodium…………….75 mg
Misoprostol………………200mcg
05-2011.
dated 21-06-2016 vide challan No. dated.
“Duplicate dossier, R & I verified”.
Pharmacological Group Anti-rheumatic, NSAID
Type of Form Form 5
Pack size & Demanded Price 2 × 10’s, As per SRO
Approval status of product in Reference (MHRA approved) Arthrotec 75 modified-release
Regulatory Authorities tablets (Each tablet consists of a gastro-resistant core
containing 75 mg diclofenac sodium surrounded by an
outer mantle containing 200 micrograms misoprostol).
Me-too status Dolact Tablet 75mg/200mcg of M/s Hiranis
Remarks of the Evaluator (PEC-XVII)  As per master formulation submitted, the tablet
consists of an enteric inner core of Diclofenac Sodium
and a film-coated outer core of Misoprostol 1%
dispersion.
Each delayed release tablet contains:
Diclofenac Sodium (as gastro-resistant inner core)
…...75mg
Misoprostol 1% dispersion (as outer core)
……...200mcg
 Provide evidence of double layer/core tablet (tablet
within tablet) manufacturing facility.
2021 & 13-07-2021.
Each delayed release tablet contains:
Diclofenac Sodium (as gastro-resistant inner core) …...75mg
Misoprostol 1% dispersion (as outer core) ……...200mcg
 Confirmation of required manufacturing equipment i.e. tablet biayered machine for
tablet within tablet manufacturing.
 Most recent GMP audit report from QA & LT Division, valid within last three years.
 Firm shall submit the fee of Rs. 30,000 for correction/pre-approval change in
composition (correction/change of formulation), as per notification No.F.7-11/2012-
meeting.
Brand Name + Dosage Form + Strength DEXIFEN 300mg tablet
Dexibuprofen…………...300 mg
05-2011 (Challan photocopy),
Dy. No., dated 21-06-2016, Differential fee Rs.
12,000/- dated 21-06-2016 vide challan No. dated.
(Duplicate dossier,. R & I verified”.
Type of Form Form 5
Approval status of product in Reference (MHRA approved)
Me-too status Extrofen 300mg tablet of M/s Lahore Chemical and
Pharmaceuticals, Lahore. Registration No. 102583
Remarks of the Evaluator (PEC-XVII)  Provide most recent/last GMP inspection report
product is non-pharmacopoeial.
 Tablet (General) Section available as per panel GMP
inspection report dated 11-01-2019.
 Registration letter shall be issued upon submission of Latest GMP inspection report
conducted within last three years alongwith fee of Rs. 7,500 for correction/pre-
approval change/ in product specifications, as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength DEXIFEN 400mg tablet
Dexibuprofen…………...400 mg
Type of Form Form 5
Me-too status Pronsad 400mg Tablet of M/s PDH pharmaceuticals,
product is non-pharmacopoeial.
2021 & 13-07-2021.
approval change/ in product specifications, as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength AMLOMAC 5mg tablet
Composition Each film coated tablet contains: -
Amlodipine (As Besylate) ………5mg
Diary No. Date of R & I & fee Dy. No. 241 dated 25-05-2011 Rs. 8,000/- dated 25-05-
2011.
Dy. No., dated 21-06-2016 Differential fee Rs.
Type of Form Form 5
Approval status of product in Reference NORVASC – 5 mg uncoated tablets (amlodipine
Regulatory Authorities besylate equivalent to 5 mg of amlodipine), USFDA
approved.
Me-too status Dolimol Tablet 5mg of M/s City Pharmaceuticals,
Each tablet contains: -
Amlodipine (As Besylate) ………5mg, along with
outlines.
official monograph.
2021 & 13-07-2021.
Decision: Approved with USP specifications and revised label claim as:
approval change/ in product specifications & label claim as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength AMLOMAC 10mg tablet
Diary No. Date of R & I & fee Dy. No. 240 dated 25-05-2011 Rs. 8,000/- 25-05-2011.
Dy. No. 2636/R&I, dated 21-06-2016, Differential fee
Rs. 12,000/- dated vide challan No. dated.
required, verified vide AD R-II letter No.F.1-11/2019-
Reg-II dated 07-05-2020).
Type of Form Form 5
Approval status of product in Reference NORVASC – 10 mg uncoated tablets (amlodipine
Regulatory Authorities besylate equivalent to 10 mg of amlodipine), USFDA
approved.
Me-too status Dolimol Tablet 10mg of M/s City Pharmaceuticals,
Amlodipine (As Besylate) ………10mg, along with
outlines.
official monograph.
2021 & 13-07-2021.
approval change/ in product specifications & label claim as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength MACLOR 4mg tablet
Lornoxicam………….4 mg
Pharmacological Group Anti-rheumatics (Anti-inflammatory agents)
Type of Form Form 5
Approval status of product in Reference Xefo 4 mg - film-coated tablets (Takeda), AGES
Me-too status Nicam 4mg film-coated tablet of M/s
S.J & G Fazul Ellahie, Karachi. Reg.No. 061603
 In application form, the product mentioned is Maclor
tablet 8mg.
 Firm has claimed manufacturer specifications; product
is non-pharmacopoeia.
approval change/ in product specifications and Product name as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength DESTADIN Tablet
Desloratadine………….5 mg
Diary No. Date of R & I & fee Dy. No. dated 01-06-2011, Rs. 8,000/- dated (),
12,000/- dated 21-06-2016 vide challan No. dated
required).
Pharmacological Group Systemic anti-histamine
Type of Form Form 5
Approval status of product in Reference (USFDA approved) CLARINEX ®(Desloratadine)
Regulatory Authorities Film-coated tablet of Schering Corporation.
Me-too status Sltera Tablet 5mg of M/s Welwrd Pharmaceuticals,

Hattar. Registration No. 101370
 Provide DRAP R & I stamped cover letter copies of
initial and differential fee submission along with fee
challans.
official monograph (USP).
2021 & 13-07-2021.
 Submission of R&I receiving from DRAP for initial submission of registration
application.
Brand Name + Dosage Form + Strength LEVOXYD 5mg tablet
Levocetirizine Dihydrochloride………… 5 mg
Diary No. Date of R & I & fee Dy. No. dated 01-06-2011, Rs. 8,000/- dated (),
Dy. No. , dated, Differential fee Rs.12,000/- dated vide
challan No. 0502343 dated 14-06-2016.
(Duplicate dossier, verification of R & I record of
challans required)
Pharmacological Group Systemic anti-histamine
Type of Form Form 5
Approval status of product in Reference (USFDA approved)
Me-too status Merlozine tablet 5mg of M/s Medicraft
pharmaceuticals, Peshawar. Registration No. 101383
challans.
2021 & 13-07-2021.
application.
Brand Name + Dosage Form + Strength PRASUMAC 10mg Tablet
Prasugrel (As hydrochloride) ……….10 mg
12,000/- dated vide challan No. 0502343 dated 14-06-
2016.
(Duplicate dossier, R & I verified”
Pharmacological Group Adenosine Diphosphate receptor antagonist, platelet
aggregation inhibitor
Type of Form Form 5
Approval status of product in Reference (USFDA approved with boxed warning. BLEEDING
Regulatory Authorities RISK) EFFIENT® 5mg & 10mg film-coated tablet,
Daiichi Sankyo.
Me-too status Prasulet 5mg Tablet of M/s Aspin pharma, Karachi.
submission of latest GMP inspection report conducted within last three years alongwith fee
of Rs. 7,500 for correction/pre-approval change/ in product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength DYCYTO 50mg Tablet
Cyproterone Acetate………….50 mg
05-2011.
Dy. No., dated 21-06-2016, Differential fee
Rs.12,000/- dated vide challan No. 0502310 dated
13-06-2016.
(Duplicate dossier,) R & I verified”.
Pharmacological Group Anti-estrogen
Type of Form Form 5
Me-too status Mileva Tablet 50mg of Aries pharma, Peshawar.
 Revise the pharmacological group from “anti-
estrogen” to “Anti-androgens, plain”.
2021 & 13-07-2021.
 Tablet (Hormone) Section available as per panel
inspection report for grant of additional section dated
18-03-2011 and 20-4-2011. However, formal approval
letter not provided.
Decision: Approved. Registration letter shall be issued upon submission of latest GMP
inspection report conducted within last three years and revised pharmacological group as
“Anti-androgens plain” alongwith fee of Rs. 7,500 for correction/pre-approval change/ in
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength DICLOMAC Tablet
Composition Each dispersible tablet contains: -
Diclofenac free acid as diclofenac sodium…….46.5mg
Diary No. Date of R & I & fee Dy. No. dated, Rs. 8,000/- dated (),
12,000/- dated vide challan No. 0502310 dated 13-
06-2016.
challans required)
Pharmacological Group Gastroprokinetics
Type of Form Form 5
challans.
 Revise the pharmacological group from
“gastroprokinetic” to “non-steroidal anti-inflammatory
and anti-rheumatics”.
or else revise label claim/composition as per reference
product. The composition and manufacturing outlines
should then be revised accordingly.
(me-too/generic) along with name, registration number
and manufacturer name.
2021 & 13-07-2021.
application.
authorities/agencies which were adopted by the Registration Board in its 275 th
meeting.
 Revision of pharmacological group from gastroprokinetic” to “non-steroidal anti-
inflammatory and anti-rheumatics”.
 Firm shall submit the fee of Rs. 7,500 for variation in registration application i.e.,
correction/change of pharmacological group, as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength XOOM 50mg Tablet
Diclofenac potassium……………...50mg
2011.
Rs.12,000/- dated vide challan No. 0502350 dated
13-06-2016.
Pharmacological Group Analgesic, Anti-inflammatory
Type of Form Form 5
Approval status of product in Reference USFDA approved Cataflam® Tablets
Me-too status Dicloflex-P Tablet 50mg of MKB Pharma, Peshawar.
2021 & 13-07-2021.
Decision: Approved with USP specifications. Registration letter shall be issued upon
submission of latest GMP inspection report conducted within last three years alongwith fee
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength EMTENO Tablet
Emtricitabine……………………...200mg
Tenofovir Disoproxil Fumarate……...300 mg
Diary No. Date of R & I & fee Dy. No. 235 dated, Rs. 8,000/- dated 25-05-2011.
12,000/- dated vide challan No. dated 13-06-2016.
(Duplicate dossier) R & I verified”.
Pharmacological Group Antiviral, activity against HIV-1 infection
Type of Form Form 5
Approval status of product in Reference (USFDA approved) Truvada (Emtricitabine and
Regulatory Authorities tenofovir disoproxil fumarate) tablets Gilead Sciences.
Me-too status Tenofo-Em Tablets of Genome pharma, Hattar.
2021 & 13-07-2021.
Decision: Approved with International pharmacopoeia specifications. Registration letter
shall be issued upon submission of latest GMP inspection report conducted within last three
years alongwith fee of Rs. 7,500 for correction/pre-approval change/ in product
Brand Name + Dosage Form + Strength DYFAMILA Tablet
Ethinyl estradiol………………………0.03mg
Levonorgestrel……………………0.15mg
05-2011(Challan photocopy),
(Duplicate dossier, R & I record verified”.
Pharmacological Group Progestogen
Type of Form Form 5
Me-too status Plan Pill Tablet of M/s Aspin pharma Karachi.
 Revise pharmacological group as “Progestogens and
estrogens, fixed combinations”, Hormonal
contraceptives for systemic use.
2021 & 13-07-2021.
 Monograph also available in USP and I.P.

Decision: Approved. Registration letter shall be issued upon revision of pharmacological
group as “Progestogens and estrogens, fixed combinations”, Hormonal contraceptives for
systemic use, submission of latest GMP inspection report conducted within last three years
alongwith fee of Rs. 7,500 for variation in registration application i.e., correction/change of
pharmacological group, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Registration board further decided to verify fee challans as per decision of 285 th
Brand Name + Dosage Form + Strength DYMOSTON 2mg/10mg Tablet
Estradiol as Hemihydrate………2mg
Dydrogesterone……….10mg
(14 orange tablets containing Estradiol Hemihydrate
2mg/tablets and 14 yellow tablets with combination of
Estradiol hemihydrate 2mg + Dydrogesterone 10mg)
05-2011(Challan photocopy),
12,000/- dated 21-06-2016 vide challan No. 0502338
dated
Pharmacological Group Contraceptive, Progestogen
Type of Form Form 5
Regulatory Authorities Femoston 2/10mg film-coated tablets
Each tablet contains 2mg oestradiol (as hemihydrate)
or a combination of 2mg oestradiol (as hemihydrate)
and 10mg dydrogesterone.
Me-too status Couldn’t be confirmed
challans.
(generic / me-too status) alongwith registration number, brand name and name of firm.
Brand Name + Dosage Form + Strength CLARIQUEN DROPS 125mg
Composition Each 5ml of reconstitution suspension contains: -
Clarithromycin (as taste-mask granules) ...125 mg
2011.
12,000/- dated vide challan No. 0562768 dated
Pharmacological Group Macrolide antibiotic
Type of Form Form 5
Pack size & Demanded Price 25ml, As per SRO
Approval status of product in Reference MHRA approved (Granules for oral suspension)
Me-too status Texklar 125mg/5ml Dry Suspension of Rotex pharma
 Revise manufacturing outlines/flow chart as per
applied formulation (Dry powder suspension) as the
submitted manufacturing outlines are for tablet.
 Specify/mention source for taste-mask pellets and also
provide CoA, accelerated and real-time stability study
data of 03 batches and GMP certificate of pellets
manufacturer.
2021 & 13-07-2021.
 General Section (Dry powder suspension) available as
per panel inspection report for grant of additional
section dated 18-03-2011 and 20-4-2011. However,
formal approval letter not provided.
Decision: Approved.
 Revised manufacturing outlines/flow chart as per applied formulation (Dry powder
suspension) as the submitted manufacturing outlines are for tablet.
 Latest GMP inspection report conducted within last three years
 Taste mask pellets source, CoA, stability study data for three batches and GMP
certificate of pellets manufacturer.
correction/change of manufacturing outlines as per notification No.F.7-11/2012-
 Firm shall submit applicable fee for pellets source fixation/approval as per
Brand Name + Dosage Form + Strength DYNIDAZOLE 500mg Suspension
Composition Each 5ml of reconstitution suspension contains
Secnidazole……………...500 mg
(Granules for oral suspension)
05-2011 (challan photocopy),
Rs.12,000/- dated 21-06-2016 vide challan No. dated
Pharmacological Group amoebicides
Type of Form Form 5
Approval status of product in Reference (USFDA approved) Oral granules: 2 g secnidazole, in
Regulatory Authorities a unit-of-use child-resistant foil packet.
SOLOSEC (secnidazole) Oral Granules, 2 g, consists
of off-white to slightly yellowish granules containing
secnidazole. SOLOSEC is supplied in one unit-of-use
child-resistant foil packet of granules in an individual
carton. Each packet contains 4.8 g of granules
containing 2gm secnidazole.
Me-too status Orasecan Dry Powder for Suspension of M/s Valor
Pharmaceuticals, Islamabad. Reg.No. 073170
declared/approved by the Registration Board in its
275th meeting as the product that is “Solosec” is
supplied in one unit-of-use child-resistant foil packet of
granules in an individual carton. Each packet contains
4.8 g of granules containing 2gm secnidazole.
 Then revise manufacturing outlines/flow chart as per
applied formulation as the submitted manufacturing
outlines are for tablet.
2021 & 13-07-2021.
 In ANSM, Secnidazole 500 granules is available in
sachet form, but the firm has applied for DS in mono
dose bottle. Status of 250mg & 500mg microgranules
in sachet is repealed on 18-09-2015. While 2gm
secnidazole in sachet is valid.
authorities/agencies which were declared/adopted by the Registration Board in its
275th meeting as the USFDA approved product that is “Solosec” is supplied in one
unit-of-use child-resistant foil packet of granules in an individual carton. Each
packet contains 4.8 g of granules containing 2gm secnidazole.
 Revision of manufacturing outlines/flow chart as per applied formulation as the
Brand Name + Dosage Form + Strength DYNIDAZOLE 750mg Suspension
Composition Each 5ml of reconstitution suspension contains
Secnidazole……………...750 mg
05-2011 (challan photocopy),
Pharmacological Group amoebicides
Type of Form Form 5
Approval status of product in Reference (USFDA approved) Oral granules: 2 g secnidazole, in
Regulatory Authorities a unit-of-use child-resistant foil packet.
SOLOSEC (secnidazole) Oral Granules, 2 g, consists
of off-white to slightly yellowish granules containing
secnidazole. SOLOSEC is supplied in one unit-of-use
child-resistant foil packet of granules in an individual
carton. Each packet contains 4.8 g of granules
containing 2gm secnidazole.
Me-too status Prosec 750mg/30ml suspension of Opal laboratories,
Karachi. Reg.No. 073706
275th meeting.
 Then revise manufacturing outlines/flow chart as per
applied formulation as the submitted manufacturing
outlines are for tablet dosage form.
2021 & 13-07-2021.
formal approval letter not provided. In case of revision
of applied formulation, the concerned section approval
will be required.
275th meeting as the USFDA approved product that is “Solosec” is supplied in one
unit-of-use child-resistant foil packet of granules in an individual carton. Each
packet contains 4.8 g of granules containing 2gm secnidazole.
 Revision of manufacturing outlines/flow chart as per applied formulation as the
 Most recent GMP audit report from QA & LT Division valid within last three years.
Brand Name + Dosage Form + Strength LEVOXYD Syrup
Levocetirizine Dihydrochloride……….0.5 mg
Diary No. Date of R & I & fee Dy. No. dated, Rs. 8,000/- dated (),
challans required).
Pharmacological Group Systemic antihistamine
Type of Form Form 5
Approval status of product in Reference Xyzal 0.5 mg/ml oral solution (MHRA approved)
Me-too status Hagel Oral solution (2.5mg/5ml) of Hiranis
Pharmaceuticals, Karachi. Reg.No. 098893
challans.
Product is non-pharmacopoeial.
 Oral liquid section available as per panel GMP
inspection report for grant of GMP certificate
Decision: Deferred for submission of R&I receiving from DRAP for initial submission of
registration application.
Brand Name + Dosage Form + Strength DEXIFEN Suspension
Dexibuprofen……….100 mg
2011.
Type of Form Form 5
Pack size & Demanded Price 60ml, 120ml, As per SRO
Me-too status Dexipro 100mg Suspension of M/s Welmark
Pharmaceuticals, Hattar. Reg.No. 076869
 Firm has claimed manufacturer specifications.
275th meeting.
275th meeting.
Brand Name + Dosage Form + Strength DACETAM Solution
Levetiracetam……….100 mg
Diary No. Date of R & I & fee Dy. No. dated 01-06-2011, Rs. 8,000/- dated 1-06-
2011 (Challan photocopy),
12,000/- dated vide challan No.0502345 dated 14-06-
2011.
challans required).
Pharmacological Group Anti-epileptic
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml, 120ml, As per SRO
Approval status of product in Reference Keppra Oral Solution 100mg/ml (USFDA approved)
Me-too status Emscot 100mg Oral Solution of M/s Scottman
pharmaceuticals, Islamabad. Reg.No. 102640
challans.
official monograph.
2021 & 13-07-2021.
 Submission of R&I receiving from DRAP for initial submission of registration.
 Revision of finished drug product specifications as per official monograph.
Brand Name + Dosage Form + Strength DYFOSF 500mg Suspension
Composition Each 5ml of reconstitution suspension contains:
Fosfomycin Calcium equivalent to
Fosfomycin…….500 mg
Pharmacological Group Phosphoric Acid Derivative, antibacterial
Type of Form Form 5
Approval status of product in Reference FOSFOCINA 250mg/5ml powder for oral suspension
Regulatory Authorities by M/s LABORATORIOS ERN, S.A. Barcelona,
España (Spain Approved)
Me-too status Califox 500mg Dry Suspension of M/s Health Care,
pharmaceuticals, Multan. Reg.No. 102358
275th meeting.
 In Spain 250mg/5ml strength is approved.
 Firm has claimed manufacturer specifications while
official monograph available in JP.
 Manufacturing outlines provided for tablet dosage
form.
2021 & 13-07-2021.
275th meeting as approved strength is Sain is 250mg/5ml.
 Revison of manufacturing outlines as firm has provided manufacturing outlines for
tablet dosage form.
 Revision of finished drug product specifications as per Japanese pharmacopoeia.
specifications and revision of manufacturing outlines as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength DYSOPRIN SR 15mg Capsules
Cyclobenzaprine HCl as extended-release pellets eq. to
Cyclobenzaprine HCl……………15mg
Diary No. Date of R & I & fee Dy. No. dated 04-04-2012, Rs. 15,000/- dated 04-04-
2012 (Challan photocopy),
85,000/- dated vide challan No. dated
challans required).
Pharmacological Group Muscle relaxant, centrally acting agents
Type of Form Form 5
Approval status of product in Reference USFDA approved (AMRIX®, Cyclobenzaprine
Regulatory Authorities hydrochloride extended-release capsules)
Me-too status Winlex-XR Capsule 15mg of M/s Winthrox
laboratories, Karachi. Reg.No. 098617
application is required.
 Provide DRAP R & I stamped cover letter copy
differential fee submission along with fee challan.
 Specify/mention source of pellets
(manufacturer/supplier), CoA of pellets, stability study
data of 03 batches and GMP certificate of pellets
manufacturer/supplier.
 Firm has claimed manufacturer specifications while
official monograph available in USP.
2021 & 13-07-2021.
 General Section (Capsule) available as per panel GMP
inspection report conducted on 11-01-2019 for grant of
GMP certificate.
application.
 Provision of extended-release pellets source (manufacturer), CoA, stability study
data of three batches of pellets and GMP certificate of pellets manufacturer.
 Submission of applicable fee for pellets source approval/fixation as per notifications
7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
592. Name and address of manufacturer/ Kanel Pharma, Plot No.6, Road SS-3, National
Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength KEMP 4mg Tablet
Glimepiride ………4mg
Diary No. Date of R & I & fee Dy. No.7045 dated 13/07/2012 Rs. 8,000/- dated 02-
07-2012 (Statistical Officer verified),
Dy. No. 605 dated 26-01-2016, Differential fee Rs.
12,000/- dated 21-01-2016 submitted vide deposit slip
No.0136036 dated 20-01-2016 (Original).
“Original Dossier”
Pharmacological Group Hypoglycemic
Type of Form Form-5
Pack size & Demanded Price 2 × 10’s, As fixed by the MoH competent authority
Approval status of product in Reference MHRA approved (Uncoated)
Me-too status Zoryl 4mg Tablet of M/s Innvotek Islamabad.
GMP status GMP certificate issued dated 04-06-2020 based on
inspection conducted on 03-06-2020.
 Revise pharmacological group as “sulphonylureas”.
 Revise master formulation and manufacturing outlines
as per label claim/composition of the applied
formulation that is un-coated tablet.
2021 & 13-07-2021.
 Tablet Section (General) available as per GMP
certificate dated 04-06-2020.
Decision: Approved. However, the firm shall submit the fee of Rs. 7,500 for correction/pre-
approval change in composition, pharmacological group and manufacturing outlines for
uncoated tablet as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength Paroxin 25mg SR capsule
Paroxetine (as hydrochloride) ……25mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Pack size & Demanded Price 30’s, As fixed by the MoH competent authority
Approval status of product in Reference USFDA approved strengths:
Regulatory Authorities Tablet and capsule 10, 20, 30, 40mg
While extended-release form is in tablet form
12.5mg, 25mg and 37.5mg
Remarks of the Evaluator (PEC-XVII)  In initial challan of Rs:15000/-, the product mentioned
as Paroxetin 12.5mg SR capsules.
275th meeting as reference product is in tablet dosage
form.
 Provide evidence of approval of drug already
registered (generic/me-too) by DRAP.
 Firm has claimed sustained release capsules, while the
formulation provided is not in accordance with label
claim for sustained release capsules.
 At annexure 1, the composition/label claim given as:
Paroxetine as hydrochloride….25mg. while the applied
formulation is capsule.
2021 & 13-07-2021.
275th meeting as reference product is in tablet dosage form.
status) alongwith registration number, brand name and name of firm as quantity of
menthol in applied formulation is different.
 Clarification is required from the firm as in the initial challan of Rs:15000/-, the
product mentioned as Paroxetin 12.5mg SR capsules, while applied product is
Paroxetin 25mg SR capsule.
 The master formulation submitted is not in accordance with label claim for sustained
release capsules.
 The composition/label claim given at Annexure-I of the registration dossier as:
Paroxetine as hydrochloride….25mg while the applied formulation is capsule.
Brand Name + Dosage Form + Strength KENSOD 150mg SR capsule
Diclofenac Sodium Pellets eq. to Diclofenac Sodium
…….150
Pharmacological Group Anti-rheumatic systemic
Type of Form Form-5
Pack size & Demanded Price 20’s, As fixed by the MoH competent authority
Approval status of product in Reference Couldn’t be confirmed
275th meeting.
 Provide evidence of approval of drug already
registered (generic/me-too) by DRAP.
 The master formulation/composition provided is for
Diclofenac sodium enteric coated pellets, while the
formulation applied is sustained release capsule.
 The manufacturing outlines are not in accordance with
applied formulation as mecobalamin and talcum are
mentioned in addition to mixing process etc.
 At annexure 3, about list of equipment, production
capacity mentioned for cephalosporin capsule section.
 Provide finished drug product specifications as per
official monograph.
 Panel inspection report dated 29-08-2012 for grant of
DML is provided for Tablet and Capsule sections.
275th meeting as reference product is in tablet dosage form.
status) alongwith registration number, brand name and name of firm as quantity of
menthol in applied formulation is different.
 The master formulation/composition provided is for Diclofenac sodium enteric
coated pellets, while the formulation applied is sustained release capsule.
 The manufacturing outlines are not in accordance with applied formulation as
mecobalamin and talcum are mentioned in addition to mixing process etc.
 At annexure 3 of the registration dossier, regarding equipment list, production
capacity mentioned for cephalosporin capsule section.
595. Name and address of manufacturer/ M/s Pharmix Laboratories (Pvt) Ltd. 21-Km,
Brand Name + Dosage Form + Strength MOVAX 800mg tablet
Metaxalone …...500mg
Diary No. Date of R & I & fee Dy. No.526 dated 21-12-2010, Rs. 8,000/- dated 21-
12-2010.
“Duplicate dossier, & I verified”
Pharmacological Group Muscle relaxant
Type of Form Form-5
Approval status of product in Reference SKELAXIN 400mg & 800mg strengths
Regulatory Authorities (USFDA approved)
GMP status GMP certificate dated 27-07-2021 issued on the basis
of evaluation conducted on 26-05-2021 & 07-07-2021.
Remarks of the Evaluator (PEC-XVII)  The label claim given is for 500mg, while the product
applied is 800mg tablet (initial, differential fee
challans, master formulation is for 800mg tablet).
 The reference product is un-coated table, while the firm
label claim is for film-coated tablet. Revise label claim
as per reference product as;
Metaxalone……800mg, along with revised master
formulation and manufacturing outlines.
 The Me-too provided that is Citolin (Reg.No.048336)
is of Citicoline (as sodium) tablet 500mg.
 Provide evidence of drug product of same composition
already approved by DRAP (Me-too/Generic) along
with Proprietary name, Registration No. and
manufacturer or else submit stability study data as per
guidelines of 293rd meeting of Registration Board,
along with applicable fee.
 Firm has claimed manufacturer specifications.
However, product official monograph available in
USP.
 Tablet Section (General) mentioned in Licensing
Division letter No.F.1-28/93-Lic dated 30-06-2020 for
renewal of DML.
2021 & 13-07-2021.
Decision: Deferred for clarification of applied formulation since the label claim/composition
provided is of Metaxalone 500mg tablet, while as per initial & differential fee challans,
master formulation, product applied is Metaxalone 800mg tablet. In case generic reference
(registered by DRAP) is not available for applied formulation firm shall submit stability
studies data as per checklist approved in 293rd meeting along with DFoprm 5D and
differential fee within 6 months.
596. Name and address of manufacturer/ M/s Pharmix Laboratories (Pvt) Ltd. 21-Km,
Brand Name + Dosage Form + Strength NEURAL 500mg tablet
Citicoline as Sodium…500mg
09-2010.
Pharmacological Group Neurotropics
Type of Form Form-5
Me-too status Citolin 500mg tablet of M/s Global pharmaceuticals,
Islamabad. Registration No.048336
GMP status GMP certificate dated 27-07-2021 issued on the basis
of evaluation conducted on 26-05-2021 & 07-07-2021.
reference regulatory authorities as adopted by the Drug
Registration Board in its 275th meeting.
 Tablet Section (General) mentioned in Licensing
Division letter No.F.1-28/93-Lic dated 30-06-2020 for
renewal of DML.
authorities/agencies which were declared/approved by the Registration Board in its 275 th
meeting as reference product is in tablet dosage form.
597. Name and address of manufacturer/ M/s Hansel Pharmaceuticals (Pvt.) Ltd. Plot No.02,
Applicant Pharma City, 30-Km, Multan Road, Sundar Lahore.
Brand Name + Dosage Form + Strength TRICOD tablet 25mg
Carvedilol…………25mg
Diary No. Date of R & I & fee Dy. No.575 dated 22-12-2010, Rs. /- dated.
12,000/- dated 20-03-2015.
Pharmacological Group Alpha/ beta blocker
Type of Form Form-5
Approval status of product in Reference Coreg 3.125 mg, 6.25 mg, 12.5 mg, 25 mg film-coated
Me-too status Carmos Tablet 25mg of Pakistan pharmaceutical and
chemical laboratories, Hyderabad. Reg. No. 101215
GMP status cGMP compliance certificate dated 10-10-2019 based
on evaluation conducted on 15-05-2019.
Remarks of the Evaluator (PEC-XVII)  The initial fee challan of Rs: 8000/- provided is for
Tricod tablet 6.25mg. Please provide fee challan for the
applied product that is Tricod 25mg tablet.
 Provide differential fee challan as submitted in the year
2015.
Carvedilol……...25mg
 Tablet Section (General) available as per cGMP
certificate issued on 10-10-2019.
 The R & I stamped cover letter copy (Dy.No.575 dated
22-12-2010) has only stamped of statistical officer. The
fee is not mentioned.
2021 & 13-07-2021.
 The firm submitted fee of Rs: 30,000/- vide online
deposit slip No.00623561 for change in composition
from 6.25mg to 25mg carvedilol.
Carvedilol……...25mg
Registration letter wil be issued upon submission of undertaking by the firm with declaration
that initial challan of Rs.8,000/- of “Tricod tablet 6.25mg” has neither been used for
processing of any other application nor will be used in future.
meeting.
598. Name and address of manufacturer/ M/s Pak Risen Pharmaceuticals, Plot No. 3, Block-B,
Applicant Phase I-II, Industrial Estate, Hattar.
Brand Name + Dosage Form + Strength GOPAIN Injection 20mg (2%)
Composition Each 1ml injection contains:
Lignocaine (as hydrochloride) ……….20mg
Diary No. Date of R & I & fee Dy. No.21 dated 20-04-2011, Rs: 8000 /- dated 20-04-
2011 (Challan photocopy dated 20-04-2011 provided)
Dy. No.468 dated 24-03-2016, Differential fee Rs:
12,000/- dated 24-02-2016 vide challan No.0535880
dated 24-02-2016.
“Duplicate dossier, R & I record of initial submission
is verified only. R & I record of differential fee
submission not verified.”
Pharmacological Group anesthetic
Type of Form Form-5
Pack size & Demanded Price 2ml glass ampoule, As per SRO
Approval status of product in Reference MHRA approved (Lidocaine 2 % with preservative
Regulatory Authorities Injection, Lidocaine 2% w/v solution for injection
Me-too status Adcaine Injection (Each 1ml injection contains
Lidocaine HCl….20mg) of M/s Ameer & Adnan
pharmaceuticals, Lahore. Registration No. 078638
GMP status Routine GMP inspection report dated 05th & 06th
August, 2021 concluded as:
Based on the areas inspected in detail, the people met
and the documents reviewed and considering the
findings of the inspection as well as type of production
facilities, the firm is not complying GMP requirements
as defined under Schedule B-II of the Drugs
(Licensing, Registering & Advertising) Rules, 1976.
 Routine GMP inspection report dated 05th & 06th
 R & I record of initial submission is verified only. R &
I record of differential fee submission could not be
verified as communicated by the R & I section.
However, differential fee challan (No.0535880)
photocopy dated 24-02-2016 submitted.
Each 2ml of solution for injection contains:
Lidocaine hydrochloride………40mg
 Lidocaine 2% with preservative Injection is used as a
local anaesthetic when injected subcutaneously. This
solution is not intended for use intravenously.
Solutions of lidocaine, which contain preservatives,
should not be used for spinal, epidural, caudal or
intravenous regional anaesthesia. Lidocaine solution
for injection is indicated for use in infiltration
anaesthesia, intravenous regional anaesthesia and
nerve blocks.
In MHRA, variety of route of administration are given
depending upon the intended purpose. Such as in
ventricular arrhythmias both IV bolus and IV infusion
are mentioned. While the IM route is also given in
specific circumstances (in case ECG monitoring is not
available).
For local anesthesia (local infiltration, spinal, epidural
or caudal, paracervical block for obstetric analgesia
(including abortion).
The preservative-free injection label given as
“For infiltration and Nerve block including caudal and
epidural use”
The injection containing preservative, label is given as
“For injection and nerve block” Not for epidural and
caudal use. Contains preservative.
official monograph.
2021 & 13-07-2021.
 Verification of differential fee submission.
 Production of the firm is suspended vide QA & LT Division letter No.F.4-2/2006-QA
(Vol-I) dated 23-08-2021 and by the CLB in its 283rd meeting held on 28-10-2021.
 Revision of label claim as:
Each 2ml of solution for injection contains:
Lidocaine hydrochloride………40mg
 Revision of finished drug product specifications as per official monograph.
 Evidence of approval of requisite manufacturing facilities by Licensing Division.
Brand Name + Dosage Form + Strength TRAXOFIN 250mg Injection (IM)
Ceftriaxone (as Sodium) ……….250mg
Diary No. Date of R & I & fee Dy. No. dated 21-05-2011, Rs: 8000 /- dated 20-05-
dated 24-02-2016.
“Duplicate dossier, R & I record of initial application
submission and differential fee submission could not
be verified.”
Pharmacological Group Cephalosporin antibiotic
Type of Form Form-5
Me-too status Getofin 250mg IM injection Getz Pharma, Karachi.
 R & I record of initial submission of application form
and differential fee submission could not be verified as
communicated by the R & I section.
 However, differential fee challan (No.0535881)
photocopy dated 24-02-2016 provided.
 Specify finished drug product specifications as per
2021 & 13-07-2021.
 Verification of R & I record of initial submission of registration application and
differential fee submission.
Brand Name + Dosage Form + Strength TRAXOFIN 500mg Injection (IM)
Ceftriaxone (as Sodium) ……….500mg
Diary No. Date of R & I & fee Dy. No. dated 21-05-2011, Rs: 8000 /- dated 20-05-
dated 24-02-2016.
submission and differential fee submission could not
be verified.”
Type of Form Form-5
Me-too status Novaxone 500mg Injection IM of M/s NovaMed
Pharmaceuticals, Ferozepur Road Lahore. Registration
No. 100875
 R & I record of initial submission of application form
and differential fee submission could not be verified as
communicated by the R & I section.
 However, differential fee challan (No.0535883)
photocopy dated 24-02-2016 submitted.
2021 & 13-07-2021.
 Verification of R & I record of initial submission of registration application and
differential fee submission.
Brand Name + Dosage Form + Strength TRAXOFIN 1gm Injection (IM)
Ceftriaxone (as Sodium) ……….1gm
Diary No. Date of R & I & fee Dy. No.22 dated 20-04-2011, Rs: 8000 /- dated 20-04-
dated 24-02-2016.
submission is verified only. R & I record of differential
fee submission not verified.”
Type of Form Form-5
GMP status Updated cGMP compliance status is required.
 R & I record of initial submission of application is
verified only.
 R & I record of differential fee submission could not be
2021 & 13-07-2021.
Brand Name + Dosage Form + Strength CD-3 Injection 5mg/ml (oral)
Composition Each 1ml injection contains:
Cholecalciferol ……….5mg
Diary No. Date of R & I & fee Dy. No.641 dated 13-07-2012, Rs: 8000 /- dated 13-
07-2012 (Challan copy not available).
dated 24-02-2016.
submission is verified only. R & I record of differential
fee submission not verified.”
Pharmacological Group Vitamin D
Type of Form Form-5
GMP status Updated cGMP compliance status is required.
 R & I record of initial submission of application is
verified only.
 R & I record of differential fee submission could not be
2021 & 13-07-2021.
603. Name and address of manufacturer/ M/s Xenon Pharmaceuticals (Pvt.) Ltd. 9.5-Km,
Applicant Sheikhupura road, Lahore.
Brand Name + Dosage Form + Strength LEVITAM 250mg tablet
Levetiracetam…........250mg
12,000/- vide challan No.1955333 dated 13-11-2019
(Original),
Pharmacological Group Anticonvulsant & antiepileptic
Type of Form Form 5
Me-too status Levepil 250mg tablet of M/s Evolution
Pharmaceuticals, Islamabad. Registration No. 087690
GMP status Panel inspection for renewal of DML and
regularization of sections conducted on 11-02-2022
and recommended renewal of DML.
Remarks of the Evaluator (PEC-XVII)  Tablet Section (General) available as per Panel
inspection for renewal of DML and regularization of
sections conducted on 11-02-2022.
 Firm has provided undertaken that the product
(Levitam 250mg tablet) has never been discussed or
deferred in any meeting and that given information are
true.
Decision: Approved. Registration board further decided to verify fee challans (initial fee
challan only) as per decision of 285th meeting.
Brand Name + Dosage Form + Strength LEVITAM 500mg tablet
(Original),
Type of Form Form 5
Me-too status Levepil 500mg tablet of M/s Evolution
(Levitam 500mg tablet) has never been discussed or
true.
Decision: Approved. Registration board further decided to verify fee challans (initial fee
Brand Name + Dosage Form + Strength LEVITAM Oral Solution (100mg/ml)
(Original),
Type of Form Form 5
Approval status of product in Reference Keppra Oral Solution 100mg/ml (USFDA approved)
Me-too status Emscot 100mg Oral Solution of M/s Scottman
pharmaceuticals, Islamabad. Reg.No. 102640
Remarks of the Evaluator (PEC-XVII)  Oral liquid (General) Section available as per Panel
 The product mentioned in DRAP R & I cover letter of
differential fee submission and differential fee challan
is Livatam syrup 10mg. The firm termed it as “typo
error”.
 R & I record for differential fee submission in original
available (DRAP R & I cover letter and fee challan,
statistical officer verified).
(Levitam syrup) has never been discussed or deferred
in any meeting and that given information are true.
Decision: Approved. Registration Board further decided to verify fee challans (initial fee
Brand Name + Dosage Form + Strength VOSTA 10mg tablet
Rosuvastatin (as calcium) …........10mg
dated 05-06-2012 (Challan Photocopy dated 05-06-
2012),
(Original),
Pharmacological Group Statins belong to Lipid Regulating drugs
Type of Form Form 5
Me-too status Novitin 10mg Tablet, 3S Pharmaceuticals, Lahore.
and recommended renewal of DML.y
 In initial fee challan (Rs:8000/-), the product
mentioned as Vosta 10mg (Rosuvastatin calcium),
while in duplicate Form 5 submitted, the label
claim/composition is revised as:
deposit slip No.954054683387 for above revision in
label claim.
 Firm has provided undertaken that the product (Vosta
10mg tablet) has never been discussed or deferred in
any meeting and that given information are true.
Brand Name + Dosage Form + Strength VOSTA 20mg tablet
dated 05-06-2012 (Challn Photocopy dated 05-06-
2012)
(Original)
Pharmacological Group Statins belong to Lipid Regulating drugs
Type of Form Form 5
Me-too status Novitin 20mg Tablet, 3S Pharmaceuticals, Lahore.
 In initial fee challan (Rs:8000/-), the product
mentioned as Vosta 20mg (Rosuvastatin calcium),
while in duplicate Form 5 submitted, the label
claim/composition revised as:
deposit slip No.38873900 for above revision in label
claim.
 Firm has provided undertaken that the product (Vosta
Brand Name + Dosage Form + Strength FORPRIDE Tablet 1mg
Glimepiride …........1mg
Metformin hydrochloride……500mg
(Original),
Pharmacological Group antidiabetic
Type of Form Form 5
Me-too status Limi Tablets 1/500mg of M/s Dyson research
laboratories, Lahore. Registration No. 078843
 Provide evidence of applied formulation in reference
regulatory authorities as adopted by Registration
 Registration Board in its 282nd meeting held on 14th –
15th May, 2018 decided to issue show cause notice to
all registered/ already marketed drug products
containing applied formulation
(Glimepiride/Metformin), on the basis that this drug
product is not available in any of the reference
regulatory authority as specified by Registration
(Forpride 1mg tablet) has never been discussed or
true.
authorities which were adopted/declared by Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength FORPRIDE Tablet 2mg
Glimepiride …........2mg
Metformin hydrochloride……500mg
(Original),
“Duplicate dossier” R & I verified”
Pharmacological Group Antidiabetic
Type of Form Form 5
Me-too status Limi Tablets 2/500mg of M/s Dyson research
 Tablet Section (General) available as per Panel
 Registration Board in its 282nd meeting held on 14th –
15th May, 2018 decided to issue show cause notice to
all registered/ already marketed drug products
containing applied formulation
(Glimepiride/Metformin), on the basis that this drug
product is not available in any of the reference
regulatory authority as specified by Registration
(Forpride 2mg tablet) has never been discussed or
true.
authorities which were adopted/declared by Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength SITOKOL Tablet 500mg
Citicoline (as Sodium) …........500mg
(Original),
“Duplicate dossier,” R & I verified”
Pharmacological Group Psychotherapeutic drug
Type of Form Form 5
Me-too status Citolin 500mg tablet of M/s Global pharmaceuticals,
 Revise pharmacological group as “Other
psychostimulants and nootropics”.
 Firm has provided undertaken that the product (sitokol
 Evidence of approval of applied formulation in reference regulatory authorities which
were adopted/declared by Registration Board in its 275th meeting.
 Revision of pharmacological group as “Other psychostimulants and nootropics”.
Brand Name + Dosage Form + Strength SITOKOL Syrup (500mg/5ml)
Citicoline (as Sodium) …........500mg
(Original),
“Duplicate dossier,” R & I verified”
Pharmacological Group Psychotherapeutic drug
Type of Form Form 5
Approval status of product in Reference Somazine 100 mg / ml oral solution.
Regulatory Authorities (CIMA Spain approved)
Me-too status E-Citi Syrupof M/s English pharmaceuticals, Lahore.
Remarks of the Evaluator (PEC-XVII)  Oral liquid (General) section available as per Panel
 Firm has provided undertaken that the product (sitokol
syrup) has never been discussed or deferred in any
meeting and that given information are true.
2021 & 13-07-2021.
 The firm shall submit the fee of Rs. 7,500 for correction/pre-approval change/ in
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-
2021.
 Registration Board further decided to verify fee challans (initial fee challan only) as
per decision of 285th meeting.
Brand Name + Dosage Form + Strength GUIDE SR Capsule 150mg
Composition Each SR capsule contains:
Itopride HCl sustained release pellets containing
Itopride HCl…........150mg
(Original),
Pharmacological Group Antiemetic & antinauseant
Type of Form Form 5
Me-too status Ipride SR 150mg Capsule of M/s Wilshire Lahore.
Remarks of the Evaluator (PEC-XVII)  Capsule (General) section available as per Panel
 Firm has provided certificate of analysis for Itopride
HCl SR pellets 60% from Vision Pharmaceuticals,
Islamabad.
 The firm to submit stability study data of 03 batches
and GMP certificate of pellets manufacturer if
availability of the applied formulation is
established/confirmed.
 Firm has provided undertaken that the product (Guide
SR capsule) has never been discussed or deferred in
 Evidence of approval of applied formulation in reference regulatory authorities which
were adopted/declared by Registration Board in its 275th meeting.
 Submission of stability study data of three (03) batches of pellets, CoA and GMP
certificate of pellets manufacturer.
 Submission of applicable fee as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021 for pellets source fixation.
Brand Name + Dosage Form + Strength KOMIN 50mg tablet
Clomiphene Citrate…........50mg
dated 05-06-2012 (Challn Photocopy dated 05-06-
2012),
(Original),
Pharmacological Group Ovulation stimulant
Type of Form Form 5
Approval status of product in Reference CLOMID® 50mg tablet (Sanofi) US FDA approved
Me-too status Fensipro 50mg tablet of M/s Evolution
pharmaceuticals Islamabad. Registration No. 101601
Remarks of the Evaluator (PEC-XVII)  Tablet (General) section available as per Panel
(Komin tablet 50mg) has never been discussed or
true.
Brand Name + Dosage Form + Strength PERKOSET tablet
Oxycodone (As hydrochloride) …........10mg
Paracetamol………………650mg
(Original),
Pharmacological Group Opioid analgesic
Type of Form Form 5
Regulatory Authorities Percocet (Oxycodone HCl 10 mg, Acetaminophen 325
mg) of Endo pharmaceuticals.
Remarks of the Evaluator (PEC-XVII)  Tablet (Psychotropic) section available as per Panel
Oxycodone hydrochloride….10mg
Acetominophen……325mg
 Provide evidence of drug with same
formulation/composition as approved by DRAP (Me-
too/generic) with proprietary name, registration
2021 & 13-07-2021.
(Perkoset tablet) has never been discussed or deferred
Brand Name + Dosage Form + Strength PERKOSET Syrup
Oxycodone (As hydrochloride) …........5mg
(Original),
Pharmacological Group Opioid analgesic
Type of Form Form 5
 Oral liquid/syrup section (Psychotropic) available as
per Panel inspection for renewal of DML and
regularization of sections conducted on 11-02-2022.
 Revise label claim as per reference product:
Each 5ml contains:
Oxycodone hydrochloride …........5mg
number and manufacturer or else submit application
on Form 5D and stability study data as per guidelines
of 293rd meeting of Registration Board along with
submission of applicable fee.
(Perkoset syrup) has never been discussed or deferred
2021 & 13-07-2021.
status) alongwith registration number, brand name and name of firm or else submit
stability studies data as per checklist approved by RegistrationBoard in its 293rd
meeting along with Form 5D declairng label claim as per reference product and
differential fee.
 Submission of fee of Rs. 30,000 for correction/pre-approval change in composition
(correction/change of salt form of the drug substance), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength BONE-D tablet
Alendronate Sodium …........91.37mg
Cholecalciferol………………5600IU
(Original),
Pharmacological Group vitamins
Type of Form Form 5
Me-too status Fosval-D Tablet of M/s Evolution Pharmaceuticals,
 Firm revised label claim as per reference product:
Alendronate (as Sodium trihydrate) …........70mg
Cholecalciferol………………5600IU (140 mcg) and
submitted fee of Rs: 30,000/- vide online deposit slip
No.5818095432.
 Firm has provided undertaken that the product (Bone-
D tablet) has never been discussed or deferred in any
Alendronate (as Sodium trihydrate) …........70mg
Cholecalciferol………………5600IU (140 mcg)
Brand Name + Dosage Form + Strength DE-DROP SYRUP
Cholecalciferol………………1000IU
(Original),
Pharmacological Group vitamins
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml & 120ml, As per SRO
Remarks of the Evaluator (PEC-XVII)  Oral liquid Section (General) available as per Panel
 Firm has provided undertaken that the product (D-
drop Syrup) has never been discussed or deferred in
Brand Name + Dosage Form + Strength VISKO Cream
Fluocinolone acetonide………………0.25mg
(Photocopy),
(Original),
Pharmacological Group Anti-inflammatory and antipruritic drugs
Type of Form Form 5
Pack size & Demanded Price 15gm, As per SRO
Approval status of product in Reference SYNALAR® (fluocinolone acetonide) Cream
Regulatory Authorities 0.025%s (fluocinolone acetonide 0.25 mg/g) (US FDA
approved)
Me-too status Fucinol Cream of M/s Jaens Pharmaceutical Industries,
Remarks of the Evaluator (PEC-XVII)  Ointment/cream Section (General) available as per
Panel inspection for renewal of DML and
 As per panel inspection for renewal of DML, “Three
dispensing areas were developed where dispensing
hoods were installed, on each for dispensing of
general, psychotropic and steroidal materials”.
 Firm has provided undertaken that the product (Visko
cream) has never been discussed or deferred in any
Brand Name + Dosage Form + Strength VISKO PLUS Cream
Fluocinolone acetonide………………0.25mg
Hydroquinone…………….40mg
Tretinoin…………….0.05mg
(Original),
Pharmacological Group Anti-inflammatory and antipruritic drugs
Type of Form Form 5
Pack size & Demanded Price 15gm, 30gm, As per SRO
Approval status of product in Reference TRI-LUMA® (fluocinolone acetonide, hydroquinone,
Regulatory Authorities and tretinoin)
cream, 0.01%/4%/0.05%. Each gram of TRI-LUMA
Cream contains 0.1mg of fluocinolone acetonide, 40
mg of hydroquinone, and 0.5 mg of tretinoin.
(US FDA approved)
Me-too status Troika Cream (Hydroquinone: 40mg (4% w/w);
Tretinoin: 0.5mg (0.05% w/w); Fluocinolone
acetonide: 0.1mg (0.01% w/w) of M/s ARP (Pvt) Ltd.
National Industrial Zone, Rawat Islamabad.
 Ointment/cream Section (General) available as per
Panel inspection for renewal of DML and
 Firm revised label claim as per reference productd as:
Each gram contains:
Fluocinolone acetonide………………0.01%
Hydroquinone…………….4%
Tretinoin…………….0.5%, but has not submitted the
requisite fee.
 As per panel inspection for renewal of DML, “Three
dispensing areas were developed where dispensing
hoods were installed, on each for dispensing of
general, psychotropic and steroidal materials”.
 Firm has provided undertaken that the product (Visko
plus cream) has never been discussed or deferred in
Decision: Approved with Innovator’s specifications & revised label claim as:
Each gram contains:
Fluocinolone acetonide………………0.01%
Hydroquinone…………….4%
Tretinoin…………….0.5%.
composition (correction/change of Fluocinolone acetonide quantitiy from 0.25mg/gm
to 0.01% in line with reference product), as per notification No.F.7-11/2012-
620. Name and address of manufacturer/ M/s Life Pharmaceutical Company, 24-III, Industrial
Applicant Estate, Multan.
Brand Name + Dosage Form + Strength ES-PRAM 10mg tablet
Escitalopram…........10mg
Diary No. Date of R & I & fee Dy. No.5904 dated 23-05-2011, Rs. 8,000/- challan
Dy.No. 25155 dated 26-11-2019 Differential fee Rs.
(Original)
Pharmacological Group antidepressant
Type of Form Form 5
Approval status of product in Reference Lexapro® (USFDA approved with boxed warning)
Regulatory Authorities WARNING: SUICIDAL THOUGHTS AND
BEHAVIORS
Me-too status Citypram tablet 10mg of M/s City pharmaceuticals,
GMP status GMP certificate dated 23-08-2021 issued based on
evaluation (DML renewal) conducted on 16-06-2021.
Remarks of the Evaluator (PEC-XVII)  Tablet (General) Section approval granted vide letter
No. F. 1-30/84-Lic (Vol.I) (M-227) dated 24-06-2011.
 Firm revised label claim as per reference product as:

Escitalopram (as oxalate) …...10mg
per official monograph (USP).
 For above revisions, the firm submitted fee of Rs:

30,000/- vide online deposit slip No.20675485926 as
per notifications 7-11/2012-B&A/DRAP dated 07-05-
2021 & 13-07-2021.
Decision: Approved with USP specifications and revised label claim as;
Brand Name + Dosage Form + Strength ES-PRAM 20mg tablet
Escitalopram…........20mg
(Original)
Pharmacological Group antidepressant
Type of Form Form 5
Approval status of product in Reference Lexapro® (USFDA approved with boxed warning)
Regulatory Authorities WARNING: SUICIDAL THOUGHTS AND
BEHAVIORS
Me-too status Citypram tablet 20mg of M/s City pharmaceuticals,

30,000/- vide online depost slip No.66431950814 as
2021 & 13-07-2021.
Decision: Approved with USP specifications and revised label claim as;
Brand Name + Dosage Form + Strength FLAMIN 20mg tablet
Piroxicam beta cyclodextrin…20mg
(Original)
Pharmacological Group Anti-inflammatory And Anti-Rheumatic Products,
Non-Steroids
Type of Form Form 5
Approval status of product in Reference BREXIN 20 mg tablets (Piroxicam 20 mg in the form
Regulatory Authorities of Piroxicam-beta cyclodextrin (complex) 191.2 mg,
AIFA approved.
Me-too status Woxicam 20mg Tablet of M/s Warafana
Pharmaceuticals, Kahuta Road, Islamabad.
Piroxicam (as Beta cyclodextrin) …...20mg
 For above revision, the firm submitted fee of Rs:

2021 & 13-07-2021.
Decision: Approved with Innovator’s specifications and revised label claim as;
Piroxicam (as Beta cyclodextrin) …...20mg
Brand Name + Dosage Form + Strength PERCIN 16mg tablet
Betahistine Dihydrochloride…16mg
(Original)
Pharmacological Group Histamine analogue
Type of Form Form 5
Approval status of product in Reference MHRA approved (uncoated tablet)
Me-too status Biglac Tablet 16mgof M/s Welmark Pharmaceuticals,
 Tablet (General) Section approval granted vide letter
 Firm revised manufacturing outlines as per label claim
for uncoated tablet as initially coating process was
mentioned in manufacturing outlines.
 Firm revised pharmacological group as Antivertigo

preparations.
 For above revisons, the firm submitted fee of Rs:

7500/- vide online deposlit slip No. 658318062859 as
2021 & 13-07-2021.
Decision: Approved.
Brand Name + Dosage Form + Strength MELAMET tablet
Artemether……….40mg
Lumefantrine……..240mg
(Original)
Pharmacological Group antimalarial
Type of Form Form 5
Approval status of product in Reference WHO prequalified drug
 Firm revised manufacturing outlines as per label claim

that is for un-coated tablet instead of coated tablet.

per official monograph (International
pharmacopoeia).

7500/- vide online deposit slip No.33837686993 as
2021 & 13-07-2021.
Decision: Approved with International Pharmacopoeia specifications.
Brand Name + Dosage Form + Strength SPORAL 100mg capsule
Itraconazole…..…100mg
(Original)
Pharmacological Group Systemic antifungals
Type of Form Form 5
Approval status of product in Reference SPORANOX® (Itraconazole 100mg) Capsules
Regulatory Authorities (USFDA approved)
 Capsule (General) Section approval granted vide letter
Itraconazole (as IR pellets) …. 100mg
 Firm specified the source/vendor of “Itraconazole IR
pellets 22.0% as M/s Vision Pharmaceuticals,
Islamabad.
 Firm has provided GMP certificate of pellets
manufacturer/supplier (M/s Vision Pharmaceuticals,
Islamabad) that is valid till 13-06-2024.
 Firm has provided DML No. 000806 copy (Semi-basic

manufacture) of M/s Vision pharmaceuticals,
Islamabad.
 Firm has provided approval letter of Itraconazole IR
pellets, grnated to M/s Vision pharmaceuticals,
Islamabad.
 Firm provided CoA of “Itraconazole IR pellets 22.0%.
 Firm has submitted real-time stability data sheets

conducted at 30 0C ± 2ºC and 65%RH ± 5%RH of three
batches for 36 months and accelerated stability data
sheets conducted at 40 0C ± 2 ºC and 75%RH ± 5%RH
of three batches for 06 months with testing points as 0,
3, 6, 9, 12, 18, 24 & 36 months (for Long term stability
studies) and 0, 3 & 6 months (for Accelerated Stability
Conditions).


7500/- vide online depost slip No. 635393498 as per
2021 & 13-07-2021.
 The firm shall submit differential fee of Rs: 22500/-

for label claim revision and pellets source fixation.
Itraconazole (as IR pellets) …. 100mg
 The firm shall submit differential fee of Rs: 22,500/- for label claim revision and pellets
source fixation (Vision pharmaceutical, Islamabad) as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021.
Brand Name + Dosage Form + Strength F-CON 200mg capsule
Fluconazole…..…200mg
(Original)
Pharmacological Group Antifungals
Type of Form Form 5
Me-too status Trinaz Capsule 200mg of M/s Trillium
pharmaceuticals, Faisalabad. Registration No. 097600
Remarks of the Evaluator (PEC-XVII)  Capsule (General) Section approval granted vide letter
 Firm revied finished drug product specifications as

per official monograph (BP).

7500/- vide online deposit slip No.898456744 as per
2021 & 13-07-2021.
Decision: Approved with BP specifications. Registration Board further decided to verify fee
challans (initial fee challan only) as per decision of 285th meeting.
Brand Name + Dosage Form + Strength BEBATE Lotion (0.05% w/v)
Betamethasone Dipropionate……..0.05% w/v
(Original)
Pharmacological Group Corticosteroids
Type of Form Form 5
Pack size & Demanded Price 25ml/bottle, As per SRO
Approval status of product in Reference DIPROSONE® (US FDA approved)
Regulatory Authorities Each gram of DIPROSONE Lotion 0.05% w/w
contains: 0.643 mg Betamethasone Dipropionate, USP
(equivalent to 0.5 mg betamethasone)
Me-too status Valisone 0.05% Lotion (Each ml contains:
Betamethasone dipropionate eq to betamethasone:
0.5mg (0.05% w/v) of M/s Crystolite pharmaceuticals,
Remarks of the Evaluator (PEC-XVII)  External liquid preparation section (General) Section
approval granted vide letter No. F. 1-30/84-Lic (Vol.I)
dated 27-04-2017.

Each ml contains:
Betamethasone (as dipropionate) …….0.5mg (0.05%
w/v)
 Firm has External liquid preparation section (General)
as evidence of availability of required manufacturing
facility for applied formulation.
 Firm has separate dispensing facility for steroidal

materials as mentioned in DML renewal inspection
report dated 16-06-2021 as “The firm provided raw
material store with de-dusting area, one sampling
booth and two dispensing booths with controlled
temperature, fitted with UV light and HEPA filters.
The firm has provided segregated dispensing hood for
steroidal and general products”.
 For above revisions, submit applicable fee as per
2021 & 13-07-2021.

 Evidence of approval of requiste manufacturing facilitiy by Licensing Division.
 Submission of fee Rs. 30,000 for correction/pre-approval change in composition
11/2012-B&A/DRAP dated 13-07-2021 since the firm revised label claim as:
Each ml contains:
Betamethasone (as dipropionate) …….0.5mg (0.05% w/v)
Brand Name + Dosage Form + Strength BEBATE Cream (0.05% w/w)
Betamethasone Dipropionate……..0.05% w/w
(Original)
Type of Form Form 5
Approval status of product in Reference (US FDA approved)
Me-too status Valisone 0.05% cream (w/w) of M/s Crystolite
pharmaceuticals, Islamabad. Registration No. 077635
 Cream/Ointment Section (General) approval granted
vide letter No. F. 1-30/84-Lic (Vol.I) (M-227) dated
24-06-2011.
Each gram contains:
Betamethasone (as dipropionate) …….0.5mg (0.05%
w/w).
 Fimr revised finished drug product specifications as

 For above revisions, firm submitted fee of Rs:

2021 & 13-07-2021.
Each gram contains:
Betamethasone (as dipropionate) …….0.5mg (0.05% w/w).
Brand Name + Dosage Form + Strength OPTEF Cream (1 % w/w)
Hydrocortisone……..10mg (1% w/w)
(Original)
Type of Form Form 5
Pack size & Demanded Price 5gm, 10gm, 20gm, As per SRO
Me-too status Arsocortison Cream 1% (10mg/gram) of M/s Arsons
Remarks of the Evaluator (PEC-XVII)  Cream/Ointment Section (General) approval granted
24-06-2011.

 For above revisions, firm submitted fee of Rs: 7500/-

vide online deposit slip No.47769565527 as per
2021 & 13-07-2021.
Decision: Approved with USP specifications. Registration Board further decided to verify
fee challans (initial fee challan only) as per decision of 285th meeting.
Brand Name + Dosage Form + Strength OPTEF Cream (2% w/w)
Hydrocortisone……..2% w/w
(Original)
Type of Form Form 5
Pack size & Demanded Price 5gm, 10gm, 20gm, As per SRO
Approval status of product in Reference USFDA approved (0.5% w/w, 1% w/w, 2.5% w/w)
Me-too status Hydrocort 2.5% Cream of M/s Atco laboratories,
24-06-2011.

Each gram contains:
Hydrocortisone…….25mg (2.5%)

 For above revisions, firm submitted fee of Rs:
2021 & 13-07-2021.
Each gram contains:
Hydrocortisone…….25mg (2.5%)
Brand Name + Dosage Form + Strength BETAVAL Cream (0.1% w/w)
Betamethasone (as valerate) …….1mg (0.1% w/w)
(Original)
Type of Form Form 5
Me-too status Berate Cream 1mg/gm (0.1%) of M/s Ciba
24-06-2011.


 For above revisions, firm submitted fee of Rs:7500/-

2021 & 13-07-2021.
Decision: Approved with USP specifications. Registration Board further decided to verify
fee challans (initial fee challan only) as per decision of 285th meeting.
Brand Name + Dosage Form + Strength CLOTIZOL HC Cream
Clotrimazole………10mg (1% w/w)
Hydrocortisone (as Acetate) …….10mg (1% w/w)
(Original)
Pharmacological Group Corticosteroid combinations
Type of Form Form 5
Approval status of product in Reference Canesten HC Cream (MHRA approved) Each gram of
Regulatory Authorities cream contains 10mg clotrimazole and 11.2mg
hydrocortisone acetate (equivalent to 10mg
hydrocortisone)
Me-too status Conic-H 1% Cream Hydrocortisone (as acetate): 10mg
(1% w/w); Clotrimazole: 10mg (1% w/w) of M/s Rotex
pharma, Islamabad. Registration No. 100798
24-06-2011.



2021 & 13-07-2021.
Brand Name + Dosage Form + Strength M-CATIN Cream
Miconazole Nitrate………20mg (2% w/w)
Hydrocortisone …….10mg (1% w/w)
(Original)
Pharmacological Group Corticosteroid combinations
Type of Form Form 5
Approval status of product in Reference Daktacort 2% / 1% w/w cream( Miconazole nitrate and
Regulatory Authorities hydrocortisone) (MHRA approved)
Me-too status Micona H Cream (Hydrocortisone: 10mg/gm
& Miconazole Nitrate: 20mg/gm of M/s Pharmasol
(Pvt) Ltd. Lahore. Registration No. 100609
24-06-2011.

2021 & 13-07-2021.
Brand Name + Dosage Form + Strength CLIMEX Cream 2% (w/w)
Clindamycin (as phosphate) ………20mg (2% w/w)
(Original)
Pharmacological Group Gynaecological anti-infective
Type of Form Form 5
Pack size & Demanded Price 20gm, 40gm, as per SRO
Approval status of product in Reference Cleocin® Clindamycin phosphate vaginal cream, USP,
Regulatory Authorities Pfizer (Each gram of cream contains clindamycin
phosphate equivalent to 20 mg or
2.0% w/w clindamycin). (USFDA approved)
Me-too status Sleek-V (2% w/w) Cream of M/s Health Care
 Cream/Ointment Section (General) approval granted
24-06-2011.
 Firm revised the route of administration as “Vaginal
cream”, instead of “topical cream” as per reference
product.
 The official monograph provided is for Clindamycin

phosphate vaginal cream, as per USP.
2021 & 13-07-2021.
Brand Name + Dosage Form + Strength SUNSAC Cream
Fluocinolone acetonide…….0.1mg (0.01% w/w)
Hydroquinone………...40mg (4% w/w)
Tretinoin……...0.5mg (0.05% w/w).
(Original)
Pharmacological Group Anti-acne preparations
Type of Form Form 5
Approval status of product in Reference TRI-LUMA® (fluocinolone acetonide, hydroquinone,
Regulatory Authorities and tretinoin), cream, 0.01%/4%/0.05%.
Each gram of TRI-LUMA Cream contains 0.1mg of
fluocinolone acetonide, 40 mg of hydroquinone, and
0.5 mg of tretinoin.
(US FDA approved)
Me-too status Troika Cream (Hydroquinone: 40mg (4% w/w);
Tretinoin: 0.5mg (0.05% w/w); Fluocinolone
acetonide: 0.1mg (0.01% w/w) of M/s ARP (Pvt) Ltd.
National Industrial Zone, Rawat Islamabad.
24-06-2011.

636. Name and address of manufacturer/ M/s Saffron pharmaceuticals (Pvt.) Limited, 19 Km,
Applicant Sheikhupura Road, Faisalabad.
Brand Name + Dosage Form + Strength CAGRELOR 90mg Tablets
Ticagrelor……..90mg
06-2012 (Fee challan copy not provided),
(Original)
Pharmacological Group Platelet aggregation inhibitor excluding heparin
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s, As per SRO
Approval status of product in Reference BRILINTA® (ticagrelor) 60mg, 90mg film-coated
Regulatory Authorities tablets (US FDA approved)
Me-too status ACS Tablet 90mg of M/s Genome pharmaceuticals,
Remarks of the Evaluator (PEC-XVII)  Tablet Section (General) mentioned in GMP
 Provide stability study data as per guidelines of 293rd

meeting of Registration Board along with submission
of applicable fee.

Decision: Deferred for submission of stability study data as per guidelines of 293 rd meeting
of Registration Board within 6 months.
637. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozepur
Brand Name + Dosage Form + Strength CEPONATE Cream (0.1% w/w)
Composition Each gram of cream contains:
Methylprednisolone aceponate…….0.1% w/w
Diary No. Date of R & I & fee Dy.No. dated, Fee Rs: 8,000/-, Date.24-05-2010,
Differential fee: Rs. 12,000 Dated 26-02-2019 vide
deposit slip No. 0819099 dated 18-02-2019.
“Duplicate dossier”
Type of Form Form-5
Approval status of product in Reference ADVANTAN methylprednisolone aceponate 1mg/g
Regulatory Authorities cream tube. TGA approved
Me-too status Solu-Pred 0.1% Cream of M/s Rotex pharma,
GMP status Panel inspection for renewal of DML conducted on 26-
10-2021 and 29-10-2021 and recommended renewal of
DML of the firm.
Remarks of the Evaluator  Cream/Ointment Section (Steroidal) mentioned in
GMP certificate dated 21-05-2019.
 Provide DRAP R & I stamped cover letter copy of

initial submission of application in the year 2010.
 Verification of R & I record need to be verified.
 The label claim has been revised as:

Each gram of cream contains:
Methylprednisolone aceponate…….0.1% w/w
Since, in the composition mentioned in master
formulation and differential fee R & I cover letter. as
Methylprednisolone (As aceponate) ….0.1% w/w.
7500/- vide online deposit slip No.17979271100. The
firm to submit differential fee of Rs: 22,500/- for label
claim revision, as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021.

application.
 Submission of differential fee Rs: 22,500/- for correction/pre-approval change in
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
638. Name and address of manufacturer/ Shrooq Pharmaceuticals (Pvt) Ltd. 21-Km, Ferozepur
Brand Name + Dosage Form + Strength CALCIPO Ointment (0.005% w/w)
Composition Each gram of ointment contains:
Calcipotriol (as monohydrate) …….50mcg
Diary No. Date of R & I & fee Dy.No.7300 dated 30-07-2010, Fee Rs: 8,000/-,
Date.30-07-2010 (Challan photocopy),
Differential fee: Rs. 12,000 Dated 26-02-2019 vide
deposit slip No. 0819096 dated 18-02-2019.
Type of Form Form-5
Approval status of product in Reference Each gram of ointment contains 0.05 mg (is equal to 50
Regulatory Authorities micrograms) of calcipotriol., MHRA approved.
Me-too status Evonex 0.005% (0.05mg/gm) Ointment of M/s
Evolution pharmaceuticals, Islamabad. Registration
No. 101641
GMP status Panel inspection for renewal of DML conducted on 26-
10-2021 and 29-10-2021 and recommended renewal of
DML of the firm.
Remarks of the Evaluator  Cream/Ointment Section (Steroidal) mentioned in
GMP certificate dated 21-05-2019.

 Firm revised pharmacological group as “antipsoriatics

for topical use”.
 Firm submitted fee of Rs: 7500/- vide online deposit

slip No. 4791289939 for above revisions as per
2021 & 13-07-2021.l
639. Name and address of manufacturer/ M/s Medisynth Pharmaceuticals, Plot No.55, Street
Applicant No.S-5, National Industrial Zone, Rawat, Islamabad.
Brand Name + Dosage Form + Strength SYNPRID 25mg Tablets
Composition Each tablet contains: -
Levosulpiride ………..25mg
Diary No. Date of R & I & fee Dy.No.899-R&I dated 01-06-2011
Dy No.1238-DDC(R-III) dated 1-06-2011, Rs.8000/-
dated 30-05-2011 (original)
Dy.No.28613(R&I) DRAP dated 30-12-2019,
Differential fee, Rs. 12,000/- dated 30-12-2019 vide
deposit slip No.0822594 dated 26-12-2019. (original)
“Original dossier”
Pharmacological Group Anti-dopaminergic
Type of Form Form-5
Approval status of product in Reference Levosulpiride Aristo 25 mg, 50mg, 100mg tablets,
Regulatory Authorities (AIFA Italy approved).
Me-too status Arrser 25mg tablet of M/s Arreta pharmaceutical
Rawalpindi. Registration No.100676
 Provide most recent/last GMP inspection report.
 In the master formula and manufacturing outlines,

coating materials and coating process is mentioned.
While the label claim is of un-coated tablet. Please
clarify and revise master formulation and
manufacturing outlines accordingly.
 Revise pharmacological group as “antipsychotics,

benzamides”.

2021 & 13-07-2021.
approval change/ in product specifications, manufacturing outlines, pharmacological
group as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Revised master formulation and manufacturing outlines as per applied label
claim/composition which is of “uncoated tablet”.
Type of Form Form-5


benzamides”.

2021 & 13-07-2021.
 Latest GMP inspection report conducted within last three years alongwith revised
master formulation and manufacturing outlines as per applied label
 Fee of Rs. 7,500 for correction/pre-approval change/ in product specifications,
manufacturing outlines, pharmacological group as per notification No.F.7-11/2012-
Type of Form Form-5


benzamides”.

2021 & 13-07-2021.
 Latest GMP inspection report conducted within last three years alongwith revised
master formulation and manufacturing outlines as per applied label
 Fee of Rs. 7,500 for correction/pre-approval change/ in product specifications,
manufacturing outlines, pharmacological group as per notification No.F.7-11/2012-
Brand Name + Dosage Form + Strength DICLO-S SR 100mg capsule
Composition Each capsule contains: -
Diclofenac Sodium ………..100mg
Pharmacological Group Phenyl acetic acid, anti-rheumatic, analgesic
Type of Form Form-5
Approval status of product in Reference Rhumalgan XL100 mg Modified-Release Capsules
Regulatory Authorities (MHRA Approved)
Me-too status Volden Forte SR 100mg Capsule of M/s Rotex pharma,
 The composition mentioned in master formulation is

of enteric coated pellets, while the product applied is
sustained release. Please clarify and revise/provide
label claim and master formulation accordingly.
 Provide source of pellets, CoA, stability study data of

three batches and GMP certificates of pellets
manufacturer/supplier.

official monograph (BP).
 The product name mentioned in differential fee

challan and cover letter as Diclocin-SR 100mg
capsule. Please clarify?

2021 & 13-07-2021.
Decision: Approved with BP specifications and revised label claim as:

Each Sustained Release capsule contains:
Diclofenac sodium (as Diclofenac sodium SR Pellets) ......................100 mg
Rregistration letter shall be issued upon submission of latest GMP inspection report
conducted within last three years
 Revised master formulation as per approved label claim for sustained release
capsules.
 Sustained released pellets source, CoA, stability study data of three batches of pellets
and GMP certificate of pellets manufacturer.
 The firm shall submit applicable fee for pellets source approval/fixation as per
notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021.
Brand Name + Dosage Form + Strength ORAZOLE Capsule
Omeprazole ……….20mg
Sodium bicarbonate……1100mg
Type of Form Form-5
Approval status of product in Reference ZEGERID® (20 mg Omeprazole and 1,100 mg
Regulatory Authorities Sodium bicarbonate) capsules (USFDA Approved)
Me-too status Ozimed Capsule 20/1100mg of M/s Welmed
pharmaceuticals, Swabi. Registration No. 102785
 In the composition/master formulation, enteric coated

pellets of omeprazole are mentioned. please clarify
and revise master formulation and manufacturing
outlines as per label claim.
 In differential fee cover letter and fee challan, the

product name given as “Carbizole capsule”. Please
clarify?

2021 & 13-07-2021.
Decision: Approved with Innovator’s specifications. Registration letter shall be issued upon
submission of following:
 Revised master formulation and manufacturing outlines as per label claim.
Brand Name + Dosage Form + Strength ORAZOLE Capsule
Omeprazole ……….40mg
Type of Form Form-5
Approval status of product in Reference ZEGERID® (40 mg Omeprazole and 1,100 mg
Regulatory Authorities Sodium bicarbonate) capsules (USFDA Approved)
Me-too status Ozimed Capsule 40/1100mg of M/s Welmed
pharmaceuticals, Swabi. Registration No. 102786
 In the composition/master formulation, enteric coated

pellets of omeprazole are mentioned. please clarify
and revise master formulation and manufacturing
outlines as per label claim.

2021 & 13-07-2021.
Decision: Approved with Innovator’s specifications. Registration letter shall be issued upon
 Revised master formulation and manufacturing outlines as per label claim.
645. Name and address of manufacturer/ M/s Caraway Pharmaceuticals, Plot No.12, Street No.
Applicant N-3, National Industrial Zone (RCCI), Rawat.
Brand Name + Dosage Form + Strength INAPAR 30mg tablet
Cinacalcet (as hydrochloride) ……30mg
deposit slip No.0577870 dated 11-05-2017.
Pharmacological Group calcimimetics
Type of Form Form-5
Approval status of product in Reference SENSIPAR® (cinacalcet) 30mg, 60mg & 90mg film-
Regulatory Authorities coated tablets (USFDA Approved)
Me-too status Mimcipar 30mg Tablets of M/s Genome
pharmaceuticals, Hattar. Registration No. 082301
Remarks of the Evaluator (PEC-XVII)  Challan of initial fee submission not provided.


meeting of Drug Registration Board.
 The label claim has been revised as:
Since, in the cover letter of initial submission, the
composition mentioned as “Cinacalcet
hydrochloride….30mg
2021 & 13-07-2021.

 Submission of stability study data as per guidelines of 293rd meeting of Drug
Registration Board.
646. Name and address of manufacturer/ M/s Caraway Pharmaceuticals, Plot No.12, Street No.
Applicant N-3, National Industrial Zone (RCCI), Rawat.
Brand Name + Dosage Form + Strength INAPAR 60mg tablet
deposit slip No.0577871 dated 11-05-2017.
Pharmacological Group calcimimetics
Type of Form Form-5
Approval status of product in Reference SENSIPAR® (cinacalcet) 30mg, 60mg & 90mg film-
Regulatory Authorities coated tablets (USFDA Approved)
Me-too status Mimcipar 60mg Tablets of M/s Genome
 Challan of initial fee submission not provided.



meeting of Drug Registration Board.
 In the cover letter of initial submission, the

composition mentioned as “Cinacalcet
hydrochloride….60mg

2021 & 13-07-2021.
 Submission of stability study data as per guidelines of 293rd meeting of Drug
Registration Board.
647. Name and address of manufacturer/ M/s Medicraft Pharmaceutical (Pvt.) Ltd., 126-B,
Applicant Industrial Estate, Hayatabad, Peshawar.
Brand Name + Dosage Form + Strength LUMART (Dispersible) Tablet
Artemether……20mg
Lumefantrine……120mg
Diary No. Date of R & I & fee Dy.No.2284 DDC Reg-IV dated 06-07-2012 (original)
Dy.No.546 dated 29-07-2013. Fee, Rs. 12,000/- dated
29-07-2013 vide challan No.0024741 dated 27-07-
2013. (Challan photocopy)
Fee Rs: 8000/- dated 16-06-2016 vide deposit slip
No.0511252 dated 15-06-2016 (original).
Type of Form Form-5
Approval status of product in Reference WHO prequalified Tablet Dispersible 20mg/120mg
Me-too status Artecxin Dispersible Tablet of M/s Highnoon
laboratories, Multan. Registration No. 062802
GMP status GMP inspection report dated 10-05-2022 provided,
wherein the panel recommends grant of cGMP
certificate for export purpose.
 Firm revised label claim as per applied formulation as:
Each dispersible tablet contains:
Lumefantrine….120mg
 Firm revised manufacturing outlines as per applied
formulation since Coating process is mentioned in
manufacturing outlines while the product applied is
dispersible tablet.
 Tablet section (General) available as per DML

renewal letter No.F.3-3/92-Lic (Vol-IV) dated 17-09-
2021.

slip No. 68271839260 for above revisions, as per
2021 & 13-07-2021.
 Firm to submit remaining fee of Rs: 22,500/- for label
claim revision as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021.
Artemether………... 20mg
Lumefantrine……... 120
composition (correction/change of formulation from tablet to dispersible tablet), as
meeting.
Brand Name + Dosage Form + Strength LUMART FORTE (Dispersible) Tablet
Diary No. Date of R & I & fee Dy.No.2283 DDC Reg-IV dated 06-07-2012.
Dy.No. 546 dated 29-07-2013. Fee, Rs. 12,000/- dated
29-07-2013 vide deposlit slip No.0024742.
Type of Form Form-5
Approval status of product in Reference WHO prequalified Tablet, Dispersible 40mg/240mg
Me-too status Artecxin Forte Dispersible tablet of M/s Highnoon
 Firm revised label claim as per applied formulation as:
Lumefantrine….240mg
 Firm revised manufacturing outlines as per applied
formulation since Coating process is mentioned in
manufacturing outlines while the product applied is
dispersible tablet.
2021.

slip No. 281791764153 for above revisions, as per
2021 & 13-07-2021.
 Firm to submit remaining fee of Rs: 22,500/- for label

claim revision as per notifications 7-11/2012-
B&A/DRAP dated 07-05-2021 & 13-07-2021.
Artemether………... 40mg
Lumefantrine……... 240
composition (correction/change of formulation from tablet to dispersible tablet), as
meeting.
Brand Name + Dosage Form + Strength LUMART DS (Dispersible) Tablet
Diary No. Date of R & I & fee Dy.No.2285 DDC Reg-IV dated 06-07-2012.
Dy.No. 546 dated 29-07-2013. Fee, Rs. 12,000/- dated
29-07-2013.
Type of Form Form-5
Me-too status Artecxin Plus Dispersible Tablet (80/480) of M/s
Highnoon Laboratories, Lahore. Registration No.
067820
in reference regulatory authorities as adopted by
 Coating process is mentioned in manufacturing
outlines while the product applied is dispersible tablet.

2021.
authorities which were declared/adopted by Registration Board in its 293rd meeting.
650. Name and address of manufacturer/ M/s Noa Hemis Pharmaceuticals, Plot No. 154, Sector
Brand Name + Dosage Form + Strength XIROX 250mg capsule
Azithromycin dihydrate…….250mg
Diary No. Date of R & I & fee Dy.No.733 dated 16-05-2012, Fee Rs: 8000/- dated
dated 16-05-2012 vide challan dated 09-05-2012
(challan photocopy provided).
Dy.No. 586 dated 20-04-2015, Differential fee dated
20-04-2015, Rs. 12,000/- vide deposit slip No.0281253
dated 17-04-2015.
Pharmacological Group Macrolides/ antibiotics
Type of Form Form-5
Approval status of product in Reference MHRA approved.
Me-too status Mascin 250mg capsule of M/s Regal pharmaceuticals,
GMP status GMP certificate dated 20-06-2019, based on evaluation
Remarks of the Evaluator (PEC-XVII)  Capsule (General & Antibiotic) Sections mentioned in
DML renewal letter No.F.2-3/98-Lic (Vol-II) dated
17-07-2019.

Azithromycin (As dihydrate) ……250mg
 Provide evidence of availability of requisite testing
facilities as per USP monograph, as the product
testing requires Amperometric electrochemical
detector.

2021 & 13-07-2021.
 Drug Manufacturing License of the firm has been suspended by the CLB in its 280th
meeting dated 26-27th April 2021.
 Revision of label claim as per reference product as;
Azithromycin (as dihydrate) ……250mg
 Evidence of availability of requisite testing facilities as per USP monograph, as the
product requires amperometric electrochemical dectector.
Brand Name + Dosage Form + Strength XIROX-D 500mg capsule
Azithromycin dihydrate…….500mg
Diary No. Date of R & I & fee Dy.No. 731 dated 16-05-2012, Fee Rs: 8000/- dated
16-05-2012 vide challan dated 09-05-2012 (photocopy
provided).
dated 17-04-2015.
Pharmacological Group Macrolides/ antibiotics
Type of Form Form-5
Approval status of product in Reference Couldn’t be confirmed.
Me-too status Azmy 500mg Capsules of M/s Filix Pharmaceuticals
Rawalpindi. Registration No. 077695
17-07-2019.

in reference regulatory authorities as adopted by the
 Provide evidence of availability of requisite testing

facilities as per USP monograph, as the product
testing requires Amperometric electrochemical
detector.

2021 & 13-07-2021.
 Evidence of approval of applied formulation in reference regulatory authorities
which were adopted/declared by Registration Board in its 275th meeting.
Brand Name + Dosage Form + Strength FESTER 4mg Tablet
Fesoterodine fumarate…….4mg
16-05-2012, vide challan dated 09-05-2012 (challan
photocopy provided).
dated 13-01-2017.
Pharmacological Group Muscarinic receptor antagonist with muscle relaxant
and urinary anti-spasmodic properties
Type of Form Form-5
Approval status of product in Reference TOVIAZ® (Fesoterodine fumarate) extended-release
Regulatory Authorities tablets 4mg, 8mg (film-coated), USFDA approved
 Tablet (General & Antibiotic) Sections mentioned in
17-07-2019.

Registration Board in its 275th meeting or else revise
label claim as per reference product, which in the form
of film-coated extended-release tablets.
 The master formulation, manufacturing outlines

should also be revised accordingly.
 Official monograph not available.

 Resubmission of application on Form 5-D along with

stability data as per guidelines of 293rd meeting of
Registration board, along with submission of
applicable fee.

2021 & 13-07-2021.
 Evidence of approval of applied formulation in reference regulatory authorities as

adopted by the Registration Board in its 275th meeting or else revise label claim as
per reference product, which in the form of film-coated extended-release tablets.

stability study data as per guidelines of 293rd meeting of Registration Board.
Brand Name + Dosage Form + Strength FESTER-D 8mg Tablet
Fesoterodine fumarate…….8mg
16-05-2012 vide challan dated 09-05-2012 (challan
Dy.No. 3306 dated 02-02-2017, Differential fee, Rs.
12,000/- dated 02-02-2017 vide deposit slip
No.0538836 dated 13-01-2017.
Pharmacological Group Muscarinic receptor antagonist with muscle relaxant
and urinary anti-spasmodic properties
Type of Form Form-5
Pack size & Demanded Price 2 ×10’s, As per SRO
Approval status of product in Reference TOVIAZ® (Fesoterodine fumarate) extended-release
Regulatory Authorities tablets 4mg, 8mg (film-coated), USFDA approved
17-07-2019.

Registration Board in its 275th meeting or else revise
label claim as per reference product, which in the form
of film-coated extended-release tablets.
 The master formulation, manufacturing outlines

 Official monograph not available.

 Resubmission of application on Form 5-D along with

stability data as per guidelines of 293rd meeting of
Registration board, along with submission of
applicable fee.

2021 & 13-07-2021.
 Evidence of approval of applied formulation in reference regulatory authorities as

adopted by the Registration Board in its 275th meeting or else revise label claim as
per reference product, which in the form of film-coated extended-release tablets.

Brand Name + Dosage Form + Strength ZAROFEN 80mg Tablet
Zaltoprofen…….80mg
16-05-2012 vide challan dated 09-05-2012.
No.0281255 dated 17-04-2015.
Pharmacological Group Non-steroidal aromatase inhibitor/ovulation stimulants
Type of Form Form-5
Approval status of product in Reference Soleton film-coated tablet (PMDA Japan approved)
Remarks of the Evaluator (PEC-XVII)  Tablet (General & Antibiotic) Sections mentioned in
17-07-2019.
 Revise pharmacological group as “Non-steroidal anti-

inflammatory drug”.

Zaltoprofen…….80mg.
The master formulation and manufacturing outlines
official monograph (Japanese pharmacopoeia).

number and manufacturer or else resubmit application
on Form 5-D along with stability data as per
guidelines of 293rd meeting of Registration board,
along with submission of applicable fee.

2021 & 13-07-2021.

Zaltoprofen…….80mg.
 Revision of finished drug product specificaitons as per Japanese pharmacopoeia.
 Submission of fee of Rs. 7,500 for correction/pre-approval change/ in product

specifications and composition (from tablet to film-coated tablet) as per notification
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength RICODA 5mg Tablet
Rosuvastatin calcium…….5mg
16-05-2012 vide challan dated 09-05-2012 (Challan
No.0538839 dated 13-01-2017.
Pharmacological Group HMG-CoA reductase inhibitors/Lipid lowering agent
Type of Form Form-5
Me-too status Saytin Tablet 5mg of M/s Saydon pharmaceuticals,
Peshawar. Registration No. 100367
17-07-2019.

Rosuvastatin (as calcium) …….5mg.
2021 & 13-07-2021.
Rosuvastatin (as calcium) …….5mg.
 Revision of finished drug product specificaitons as per official monograph (USP).
Brand Name + Dosage Form + Strength BONARIC 150mg Tablet
Ibandronic acid…….150mg
No.0538838 dated 13-01-2017.
Pharmacological Group Bisphosphonates
Type of Form Form-5
Approval status of product in Reference BONIVA (Ibandronate sodium) Tablets (USFDA
Regulatory Authorities approved)
Me-too status BONVIVA TABLET 150mg of M/s Marti Dow Ltd.
17-07-2019.

Ibandronic acid (as sodium monohydrate)
…….150mg.

2021 & 13-07-2021.

Ibandronic acid (as sodium monohydrate) …….150mg.
Brand Name + Dosage Form + Strength NEUROMIN 500mcg Tablet
Mecobalamin…….500mcg
No.0538834 dated 13-01-2017.
Pharmacological Group Not provided
Type of Form Form-5
Approval status of product in Reference Neumethecol 500mcg tablet by Hisui pharma
Regulatory Authorities (PMDA Japan approved)
Me-too status Acobmin 500mcg sugar coated tablet of M/s
Cunningham Pharmaceuticals, Lahore.
17-07-2019.

Each sugar-coated tablet contains:
Mecobalamin …….500mcg.
official monograph (Japanese pharmacopoeia).

2021 & 13-07-2021.
 Decision in 313th DRB meeting for mecobalamin

500mcg tablet “Deferred for confirmation of
requirement of JP monograph regarding storage
and testing of drug substance and container
closure system of drug product.
Each sugar-coated tablet contains:
Mecobalamin …….500mcg.
 Revision of finished drug product specificaitons as per Japanese pharmacopoeia.

specifications and composition (from tablet to sugar-coated tablet) as per
Brand Name + Dosage Form + Strength UFLO-D Capsule
Tamsulosin…….0.4mg
Dutasteride…….0.5mg
12,000/- vide deposit slip No.0281257 dated 17-04-
2015.
Pharmacological Group 5-alpha reductase inhibitors & alpha-blockers
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, As per SRO
Approval status of product in Reference JALYN (0.5 mg Dutasteride and 0.4 mg Tamsulosin
Regulatory Authorities hydrochloride) capsules, USFDA approved
Me-too status Maxflow-D Capsule (Each capsule contains:
Tamsulosin hydrochloride (extended-release pellets)
eq to tamsulosin hydrochloride: 0.4mg;
Dutasteride (as soft gel capsule): 0.5mg
Of M/s CCL pharmaceuticals, Lahore.
17-07-2019.
 The product approved in reference country contains

Tamsulosin HCl SR pellets and soft gel capsule of
Dutasteride filled in hard gelatin capsule shell.
Provide the following information regarding
manufacturing of the product.
 Provide source of Tamsulosin Pellets, GMP certificate

of pellet manufacturer, Certificate of analysis,
stability study data of 3 batches according to the
climatic conditions of zone IV-A and in case of
imported pellets submit differential fee as well.
 Provide source of Dutasteride soft gel capsule. In case

of In-house manufacturing of Dutasteride soft gel
capsule, provide approval of relevant
section/manufacturing facility that is soft gel capsule
section. In case of imported dutasteride soft gel
capsule, provide the following along with the
submission of differential fee:
 Certificate of analysis.
 Attested copy of valid Drug Sale License.
 Attested copy of Valid Sole agency agreement

/Authority letter.
 Original Embassy attested CoPP.
 Original Embassy attested GMP certificate of
manufacturer.
 Accelerated stability study data & Long-term Stability
studies according to Zone IV-A.

Tamsulosin hydrochloride (extended-release pellets)
eq to tamsulosin hydrochloride……...0.4mg
Dutasteride (as soft gel capsule) ………0.5mg
 Complete method of manufactur of tamsulosin and
dutasteride soft gel capsule into final dosage form.
 Manufacturing facility and equipment for
manufacturing.
 Evidence of availability of manufacturing

facility/equipment that is “capsule in capsule filling”
machine.

2021 & 13-07-2021.
 The drug product, FLODART™ (Dutasteride and

Tamsulosin hydrochloride) Capsules, is a pre-printed
hard-shell capsule containing one Dutasteride soft
gelatin capsule (0.5 mg Dutasteride) and Tamsulosin
hydrochloride pellets (containing 0.4 mg Tamsulosin
hydrochloride). The pre-printed hard-shell capsules,
size 00, have a brown body and an orange cap
imprinted with “GS 7CZ” in black ink. The strength
of each active component is identical to the
commercially available AVODART®, 0.5 mg
Dutasteride and FLOMAX®, 0.4 mg Tamsulosin
hydrochloride. The capsules are manufactured by
encapsulating two intermediate products: A
Dutasteride soft gelatin capsule and Tamsulosin
hydrochloride pellets, referred to as a Dutasteride
Product Intermediate and Tamsulosin Hydrochloride
Product Intermediate, respectively. Dutasteride
Product Intermediate contains the same dose of
Dutasteride as AVODART® (Dutasteride) soft
gelatin capsules. The Tamsulosin Hydrochloride
Product Intermediate contains the same dose as
FLOMAX® (Tamsulosin hydrochloride) capsules
(NDA # 20-579). The combination drug product is
formulated to be bioequivalent to both commercial
AVODART® and FLOMAX® dosed concomitantly.
The combination capsule is intended to provide
greater convenience to patients and improved
compliance, relative to a regimen of two separate
dosage units per day
Tamsulosin hydrochloride (extended-release pellets) eq to tamsulosin HCl…0.4mg
Dutasteride (as soft gel capsule) ………0.5mg
 Source of Tamsulosin Pellets, GMP certificate of pellet manufacturer, Certificate of
analysis, stability study data of 3 batches according to the climatic conditions of zone
IV-Al.
 In case of In-house manufacturing of Dutasteride soft gel capsule, provide evidence

of approval of requisite manufacturing facilities (Soft gel capsule Section) by
Licensing Division.
 In case of imported dutasteride soft gel capsule, provide certificate of analysis,

Attested copy of valid Drug Sale License, Attested copy of Valid Sole agency
agreement /Authority letter, Original Embassy attested CoPP, Original Embassy
attested GMP certificate of manufacturer, Accelerated stability study data & Long-
term Stability studies according to Zone IV-A conditions.
 Complete method of manufactur of tamsulosin and dutasteride soft gel capsule into
final dosage form.
 Evidence of availability of manufacturing facility/equipment that is “capsule in

capsule filling” machine.
 Submission of fee applicable fee for pellets source fixation as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength FACID CREAM
Fusidic acid…….20mg (02% w/w)
16-05-2012 dated 09-05-2012 (Challan photocopy
provided).
No.0538832 dated 13-01-2017.
Type of Form Form-5
Me-too status Axxo 2% Cream of M/s Rotex pharma, Islamabad.
 Cream/Ointment (General) & Cream/Ointment
(Steroidal) Sections mentioned in DML renewal letter
No.F.2-3/98-Lic (Vol-II) dated 17-07-2019.
 Master formulation for the applied product not

provided.
 Firm has claimed manufacturer specifications,

however, product official monograph available in BP.
2021 & 13-07-2021.

 Revision of finished drug product specificaitons as per BP monograph.
 Submission of master formulation for the applied product.

Brand Name + Dosage Form + Strength FACID-H CREAM
Fusidic acid…….4%
Hydocortisone….1%
2017.
Type of Form Form-5
Approval status of product in Reference MHRA approved (emc)
Regulatory Authorities Health Canada approved
Me-too status Axxo-H 2% Cream of M/s Rotex pharma, Islamabad.
Remarks of the Evaluator (PEC-XVII)  Cream/Ointment (General) & Cream/Ointment
(Steroidal) Sections mentioned in DML renewal letter
No.F.2-3/98-Lic (Vol-II) dated 17-07-2019.
 Evidence of availability of separate dispensing facility

for steroidal materials.
Each gram contains:
Fusidic acid….20mg (2%)
Hydrocortisone acetate……10mg (1%)
2021 & 13-07-2021.

Each gram contains:
Fusidic acid…….20mg (2%)
Hydrocortisone acetate……10mg (1%)
 Evidence of availability of separate dispensing facilities for steroidal materials.

11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength KETOFEN GEL (2.5% w/w)
Ketoprofen…….25mg
16-05-2012 vide challan 09-05-2012 (challan
2015.
Type of Form Form-5
Approval status of product in Reference MHRA approved (emc)
Regulatory Authorities Health Canada approved
Me-too status Vofome Gel 2.5% of M/s E-Pharm laboratories,
Licensing division, DRAP Islamabad.
 Proposed route of administration mentioned as

“Oral”.
official monograph (B.P).
2021 & 13-07-2021.
 Revision of finished drug product specificaitons as per BP monograph.
 Submission of revised propsed route of administration.

662. Name and address of manufacturer/ M/s Weather Folds Pharmaceuticals, Plot No.69/2,
Applicant Phase-II, Industrial Estate, Hattar.
Brand Name + Dosage Form + Strength GO DEPRESS 20mg Tablet
Paroxetine (as Hydrochloride hemihydrate) …...20mg
06-2012 (Fee Challan copy not provided)
dated 12-10-2015 vide challan No. dated
Pharmacological Group Selective serotonin-reuptake inhibitors (SSRIs)
Type of Form Form 5
Me-too status Depin Tablets 20mg of M/s Pharmasol, Lahore.
Reg. No. 098092
Remarks of the Evaluator (PEC-XVII)  Provide fee challan of initial fee submission in the year
2012.
differential fee submission along with fee challan
copy.
Paroxetine (as hydrochloride) …….20mg
report.
2021 & 13-07-2021.
“Each film-coated tablet contains:
Paroxetine (as hydrochloride) …………. 20mg”
 Firm shall submit fee of Rs. 30,000 for correction/pre-approval change in
Brand Name + Dosage Form + Strength AM-TEL 5mg/40mg Tablet
Composition Each bi-layered uncoated tablet contains: -
Amlodipine Besylate eq. to Amlodipine…...5mg
Telmisartan……….40mg
Pharmacological Group Anti-hypertensive
Type of Form Form 5
Approval status of product in Reference (USFDA approved) TWYNSTA® 40/5 mg, 40/10 mg,
Regulatory Authorities 80/5 mg, 80/10 mg uncoated bi-layer tablet Boehringer
Ingelheim International GmbH.
Me-too status Tiocardis-AM Tablet 40mg/5mg of M/s Atco
2012.
copy.
 Firm has mentioned that the product complies
innovators specifications, while official monograph
available in USP.
 Provide evidence of availability of bi-layered
compression machine.
 Firm has revised label claim as per reference product
as:
Each bi-layered uncoated tablet contains: -
report.
 Evidence of availability of bi-layered compression
machine is required.
2021 & 13-07-2021.
Decision: Deferred for evidence of availability of “Bi-layer tablet compression machine.”
Brand Name + Dosage Form + Strength D-LOX 30mg Capsule
Duloxetine as enteric coated pellets 17%…...30mg
Type of Form Form 5
Regulatory Authorities Each gastro-resistant capsule, hard contains 30 mg of
duloxetine (as hydrochloride)
Me-too status Ducaid Capsule 30mg of M/s Medicaids (Pvt) Ltd.
2012.
copy.
Each hard gelatin capsule contains:
Duloxetine HCl delayed release pellets (17%) eq. to
doluxetine…30mg”.
three batches and GMP certificate of pellets
manufacturer/supplier. In case of imported pellets
source, submit applicable fee as well.
report.
2021 & 13-07-2021.
Decision: Approved a sper following label claim:
“Each hard gelatin capsule contains:
Duloxetine HCl delayed release pellets eq. to Doluxetine…….30mg.”
 Firm shall submit documents for pellets source, CoA, stability stdudy data of three
batches of pellets and GMP certificate of pellets manufacturer along with fee (in case
of import).
meeting of Registration Board
Brand Name + Dosage Form + Strength D-LOX 60mg Capsule
Type of Form Form 5
Me-too status Felice 60mg Capsules of M/s Standpharm, Pakistan,
 Provide fee challan of initial fee submission in the year
2012.
copy.
report.
2021 & 13-07-2021.
Decision: Approved a sper following label claim:
Duloxetine HCl delayed release pellets eq. to Doluxetine…….60mg.”
 Firm shall submit documents for pellets source, CoA, stability stdudy data of three
batches of pellets and GMP certificate of pellets manufacturer along with fee (in case
of import).
meeting of Registration Board
666. Name and address of manufacturer/ M/s Winbrains Research Laboratories, Plot No.69/1,
Applicant Block-B, Phase I-II, Industrial Estate, Hattar.
Brand Name + Dosage Form + Strength RAZOLE 20mg Tablet
Composition Each enteric coated tablet contains: -
Omeprazole (as Magnesium salt) …...20mg
Differential fee Rs. dated vide challan No. dated
Type of Form Form 5
Approval status of product in Reference Losec MUPS (multiple unit pellet system) 20mg
Regulatory Authorities AstraZeneca UK (MHRA approved)
Losec 20 mg gastro-resistant tablets: Pink, oblong,
biconvex, film-coated tablets, engraved with on one
side and 20 mg on the other side containing enteric
coated pellets.
Me-too status Omnat-20 Tablets of M/s Genome pharmaceuticals,
2011.
 Provide evidence of differential fee submission.
 Provide manufacturing method outlines for the product
in line with innovator’s manufacturing technology for
multiple unit pellet system (MUPS).
 The finished drug product specifications provided is
for omeprazole gastro-resistant tablet, while the
formulation applied is omeprazole (as magnesium salt)
tablet.
report.
2021 & 13-07-2021.
Decision: Deferred for evidence of availability of requisite manufacturing
facilities/technology in line with reference product for multiple unit pllets system (MUPS).
Brand Name + Dosage Form + Strength DICLO-K 50mg Tablet
Diclofenac potassium…...50mg
Type of Form Form 5
Me-too status Dicloflex-P Tablet 50mg of M/s MKB pharmaceuticals
Peshawar. Registration No. 102825
 Provide evidence differential fee submission.
report.
Decision: Approved. Registration Board further decided to verify fee challan as per decision
of 285th meeting of Registration Board.
Brand Name + Dosage Form + Strength LODEPRESS 20mg Tablet
Paroxetine (as Hydrochloride hemihydrate) …...20mg
Pharmacological Group Selective serotonin re-uptake inhibitors
Type of Form Form 5
Me-too status Depin Tablets 20mg of M/s Pharmasol, Lahore.
Reg. No. 098092
2011.
Paroxetine (as Hydrochloride) ……20mg
report.
2021 & 13-07-2021.
Paroxetine (as Hydrochloride) ……20mg
Brand Name + Dosage Form + Strength AM-TELMA 5/40mg Tablet
Composition Each bi-layered uncoated tablet contains: -
Type of Form Form 5
Approval status of product in Reference (USFDA approved) TWYNSTA® 40/5 mg, 40/10 mg,
Regulatory Authorities 80/5 mg, 80/10 mg uncoated bi-layer tablet Boehringer
Ingelheim International GmbH.
Me-too status Tiocardis-AM Tablet 40mg/5mg of M/s Atco
2011.
 Firm has revised label claim as per reference product
as:
Each bi-layered uncoated tablet contains: -
report.
 Provide evidence of requisite manufacturing facilities
(bi-layered compression machine) for the applied
formulation.
 Firm has claimed that the product complies innovators
specifications, while official monograph available in
USP.
2021 & 13-07-2021.
 Evidence of availability of “Bi-layer compression” machine along with its IQ,OQ &
PQ reports.
(correction/change of formulation from plain tablet bi-layered tablet), as per
Brand Name + Dosage Form + Strength LOXIT 60mg Capsule
Type of Form Form 5
Me-too status Felice 60mg Capsules of M/s Standpharm, Pakistan,
Remarks of the Evaluator (PEC-XVII)  Provide fee challan copy of initial fee submission in
the year 2011.
report.
 Firm has claimed that the product complies innovators
specifications, while official monograph available in
USP.
2021 & 13-07-2021.
Duloxetine HCl delayed release pellets eq. to Doluxetine…60mg.”
Registration letter will be issued upon submission of following:

 Documenst for pellets source, CoA, stability stdudy data of three batches of pellets
and GMP certificate of pellets manufacturer and fee (in case of import).
 Fee of Rs. 30,000 for correction/pre-approval change in composition
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength PREGBA 50mg Capsule
Pregabalin…...50mg
Pharmacological Group Anti-convulsant
Type of Form Form 5
Me-too status Gabler 50mg Capsule of M/s Innvotek
2011.
 Firm has given innovators specifications and
monograph provided from Indian pharmacopoeia.
report.
Decision: Approved with BP specifications. Firm shall submit the fee of Rs. 7,500 for
correction/pre-approval change/ in product specifications, as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength GABAPEN 300mg Capsule
Gabapentin…...300mg
Pharmacological Group Anti-convulsant
Type of Form Form 5
Me-too status Vegapent 300mg Capsule of M/s Vega
2011.
report.
Decision: Approved. Registration Board further decided to verify fee challan as per decision
673. Name and address of manufacturer/ M/s Derma Techno Pakistan, Plot No. 528, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore.
Brand Name + Dosage Form + Strength OXIFLOX 4mg TABLET
Moxifloxacin (As hydrochloride) …...400mg
06-2011 (Fee challan copy dated 01-06-2011 provided)
Dy.No.26881(R & I) dated 12-12-2019, Differential
fee Rs. 12,000/- dated 12-12-2019 vide challan
Pharmacological Group Quinolones
Type of Form Form 5
Me-too status Oxef 400mg Tablet of M/s Parmedic laboratories,
Remarks of the Evaluator (PEC-XVII)  Tablet (General) Section mentioned in letter No.F.1-
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
Registration letter shall be issued upon submission of latest GMP inspection report
conducted within last three years alongwith fee of Rs. 7,500 for correction/pre-approval
change/ in product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-
07-2021.
 Registration Board further decided to verify fee challan (initial fee challan) as per
decision of 285th meeting of Registration Board.
Brand Name + Dosage Form + Strength METHLUM TABLET
Artemehter…...20mg
Pharmacological Group Synthetic anti-malarial derived from
artemisinin/synthetic racemic fluorine mixture
Type of Form Form 5
Me-too status Ajmetlum Tablet 20/120mg of M/s AJM pharma,
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
Decision: Approved with International Pharmacopoeia specifications and revised label claim
as:
“Each tablet contains:
Lumefantrine……120mg.”
conducted within last three years alongwith f fee of Rs. 7,500 for correction/pre-
approval change/ in product specifications and composition (from film-coated tablet
to core tablet) as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
meeting.
Brand Name + Dosage Form + Strength METHLUM-DS TABLET
Artemehter…...40mg
Pharmacological Group Synthetic anti-malarial derived from
artemisinin/synthetic racemic fluorine mixture
Type of Form Form 5
 Tablet (General) Section mentioned in letter No.F.1-
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
Decision: Approved with International Pharmacopoeia specifications and revised label claim
as:
Lumefantrine……240mg.
conducted within last three years alongwith f fee of Rs. 7,500 for correction/pre-
approval change/ in product specifications and composition (from film-coated tablet
to core tablet) as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength TENDEC PLUS TABLET
Atenolol…...50mg
Chlorthalidone…….12.5mg
Pharmacological Group Cardioselective beta-blocker/thiazide diuretic
Type of Form Form 5
Approval status of product in Reference MHRA approved (film-coated tablet)
Me-too status Wnsol C Tablet 50mg/12.5mg of M/s Welmark
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
submission of latest GMP inspection report conducted within last three years along with fee
No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength LSK-H TABLET
Losartan potassium…...50mg
Pharmacological Group Angiotensin II receptor antagonist/thiazide diuretic
Type of Form Form 5
Approval status of product in Reference MHRA approved (film-coated tablet)
Me-too status Lozarta HCT Tablet 50mg/12.5mg of M/s Lisko
Pakistan, Karachi. Registration No. 094816
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
submission of:
 GMP audit report from QA & LT Division, valid within last three years.
Brand Name + Dosage Form + Strength ANTRON TABLET
Ondansetron (as hydrochloride dihydrate) …...8mg
Pharmacological Group Anti-emetics
Type of Form Form 5
Approval status of product in Reference ZOFRAN® (ondansetron hydrochloride) 4mg & 8mg
Regulatory Authorities tablets Novartis pharma (US FDA approved)
Me-too status Ondesmed Tablet 8mg Medicraft Pharmaceuticals
(Pvt) Ltd. Peshawar. Registration No. 101379
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
submission of:
 Registration Board decided to verify fee challan (initial fee challan) as per decision
Brand Name + Dosage Form + Strength TRAMADEC-SR 100mg TABLET
Composition Each sustained release tablet contains: -
Tramadol hydrochloride…...100mg
Pharmacological Group Opiate analogue
Type of Form Form 5
Approval status of product in Reference Maneo 100 mg Prolonged-release tablets (MHRA
Regulatory Authorities approved)
Me-too status Taram-SR Tablet (Each film coated sustained release
tablet contains. tramadol HCl….100mg) of Noa hemis
pharmaceuticals, Karachi. Registration No. 100224
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
submission of:
Brand Name + Dosage Form + Strength OXITHRO 150mg TABLET
Roxithromycin…...150mg
Pharmacological Group Macrolide
Type of Form Form 5
Approval status of product in Reference ROXIMYCIN 150mg film coated tablet
Regulatory Authorities (TGA Approved)
Me-too status Roxtro Tablet 150mg of M/s Lisko Pakistan, Karachi.
51/2005-Lic (Vol-I) dated 17-07-2019.
report.
2021 & 13-07-2021.
submission of:
Brand Name + Dosage Form + Strength ASTHAMAID 5mg TABLET
Monteluksat (as sodium) …...5mg
Pharmacological Group Leukotriene receptor antagonist / anti-asthamatic
Type of Form Form 5
Approval status of product in Reference Singulair (4mg, 5 mg) Chewable Tablet
Regulatory Authorities (US FDA Approved)
Me-too status Dowkast 5mg chewable tablet of M/s Seatle (Pvt) Ltd.
Lahore Registration No. 103296
51/2005-Lic (Vol-I) dated 17-07-2019.
reference regulatory authorities as adopted by the
registration board in its 275th meeting or else revise
label claim as per reference product as:
Each chewable tablet contains:
Montelukast (as sodium) ……5mg, along with
submission of revised master formulation and
manufacturing outlines.
report.
2021 & 13-07-2021.
Each chewable tablet contains:
Montelukast (as sodium) ……5mg
Registration letter shall be issued upon submission of:
composition (correction/change of formulation from film-coated tablet to chewable
tablet), as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Brand Name + Dosage Form + Strength N-FLOX 400mg TABLET
Norfloxacin…...400mg
Pharmacological Group Quinolones
Type of Form Form 5
Approval status of product in Reference (US FDA approved) Noroxin 400mg of Merck Sharp
Regulatory Authorities & Dohme. status is discontinued with remarks
**Federal Register determination that product was not
discontinued or withdrawn for safety or effectiveness
reasons**
Me-too status Nortic 400mg tablet of M/s Reign pharmaceuticals,
Karachi. Registration No.100087
51/2005-Lic (Vol-I) dated 17-07-2019.
 Revise composition/master formulation and
manufacturing outlines as per label claim since coating
materials and coating process not mentioned.
 The firm has claimed USP specifications, while the
product was previously available in USP, is
unavailable in version USP 43 NF 38 and in version
USP 44 NF 39 2021, available with remarks “delete
the following”.
 Official monograph available in BP and Japanese
Pharamcopoeis.
report.
2021 & 13-07-2021.
Decision: Approved with BP specifications. Registration letter shall be issued upon
submission of:
Brand Name + Dosage Form + Strength IPTOZ TABLET
Composition Each chewable tablet contains: -
Iron (III) hydroxide polymaltose complex equivalent to
elemental Iron…...100mg
Folic acid…….0.35mg
Pharmacological Group Haematinic
Type of Form Form 5
Pack size & Demanded Price 2 × 10’s, As per SRO
Me-too status Fogyma 100mg/0.35mg chewable tablet of M/s
Theramed Pharma, Lahore. Reg.No. 101702
51/2005-Lic (Vol-I) dated 17-07-2019.
 Ferrum Fol 100 mg / 350 micrograms, Chewable
Tablets (Iron as Iron (III)-hydroxide polymaltose
complex / folic acid) Vifor France (PIL available on
google)
official monograph not available.
report.
2021 & 13-07-2021.
Decision: Approved with innovator’s specification, since iron preparations are not
considered as drug by various reference regulatory authorities.
Brand Name + Dosage Form + Strength YDOX 50mg TABLET
Doxycycline (as Hyclate) …...50mg
Pharmacological Group Antibiotic, tetracycline derivative
Type of Form Form 5
51/2005-Lic (Vol-I) dated 17-07-2019.
(generic/me-too) with brand name, registration
report.
2021 & 13-07-2021.
 Revision of master formulation/composition and manufacturing outlines as per
applied formulation as coating materials and coating process not mentioned.
correction/change of master formulation and manufacturing outlines, as per
Brand Name + Dosage Form + Strength TRAMADEC CAPSULE
Tramadol hydrochloride…...50mg
Pharmacological Group Opiate analogue
Type of Form Form 5
Approval status of product in Reference MHRA approved (Hard capsule)
Me-too status Macmadol 50mg Capsule of M/s Searl IV solutions,
Remarks of the Evaluator (PEC-XVII)  Capsule (General) Section mentioned in letter No.F.1-
51/2005-Lic (Vol-I) dated 17-07-2019.
manufacturing outlines as per label claim as the master
formulation and manufacturing outlines are provided
for tablet dosage form.
report.
2021 & 13-07-2021.
Decision: Approved. Registration letter shall be issued upon submission of:
 Revised master formulation/composition and manufacturing outlines for applied
formulation (capsule dosage form).
correction/change of master formulation and manufacturing outlines, as per
Brand Name + Dosage Form + Strength TECHNOVIT-C tablet
Thiamine mononitrate (Vit. B1) ……...15mg
Riboflavin (Vit.B2) ………15mg
Pyridoxine HCl (Vit.B6) …….10mg
Cyanocobalamine (Vit. B12) ……10mcg
Calcium Pantothenate……25mg
Nicotinamide…………50mg
Ascorbic acid (Vit. C)……….300mg
Diary No. Date of R & I & fee Dy.No. dated 24-05-2011, Fee Rs: 8000/- dated 24-05-
2011 (Challan photocopy dated 23-05-2011)
Dy. No.1118 dated 03-06-2011, Rs. 8,000/- dated 03-
Pharmacological Group Vitamins
Type of Form Form 5
Me-too status Polybion Forte 'C' tab
Thiamine mononitrate……. 15mg
Riboflavin……15mg
Pyridoxine HCl……. 10mg
Cyanacoblamine…… 10mcg
Calcium pantothenate…… 25mg
Nicotinamide……… 50mg
Ascorbic acid……… 300mg
of M/s Martin Dow Marker Ltd. Quetta. Registration
no. 001492
 Tablet (General) Section mentioned in letter No.F.1-
51/2005-Lic (Vol-I) dated 17-07-2019.
reference regulatory authorities as declared/adopted by
 The firm has provided two different DRAP R & I
stamped cover letters dated 24-05-2011 & 03-06-2011
with respective fee challans for the same formulation.
Needs clarification.
report.
2021 & 13-07-2021.
Decision: Approved. Firm shall submit fee of Rs. 7500/- for correction/pre-approval change
in product composition for film coated tablet as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021 along with latets GMP inspection report conducted within last three years.
GMP audit report from QA & LT Division, valid within last three years.
Brand Name + Dosage Form + Strength FIZCAL-1000 TABLET
Composition Each effervescent tablet contains: -
Calcium Lactate …………… 422mg
Calcium Gluconate ………… 578mg
Calcium Carbonate ………… 327mg
Sodium Carbonate …………. 1gm
Vitamin C …………………. 500mg
Sugar ………………………. 2gm
Orange Flavour ……………... 50mg
Diary No. Date of R & I & fee Dy.No. dated 24-05-2011, Fee Rs: 8000/- dated 24-05-
2011 (Challan photocopy dated 23-05-2011)
Dy. No.1128 dated 03-06-2011, Rs. 8,000/- dated 03-

Pharmacological Group Calcium supplement
Type of Form Form 5
Me-too status CaC-1000 Effervescent Tablet
(Calcium Lactate Gluconate……...1000mg (Calcium
Gluconate ….578mg) (Calcium Lactate……...422mg)
Vitamin C (Ascorbic Acid) …………….…….500mg
Calcium Carbonate ……327mg of M/s GSK OTC
(Pvt) Ltd. Jamshoro. Registration No. 084642
51/2005-Lic (Vol-I) dated 17-07-2019.
 Revise composition/master formulation as per label
claim that is for effervescent tablet.
 The firm has provided two different DRAP R & I
stamped cover letters dated 24-05-2011 & 03-06-2011
with respective fee challans for the same formulation.
Needs clarification.
number and manufacturer as the me-too provided has
different composition than the applied formulation.
report.
2021 & 13-07-2021.
 Revise composition/master formulation as per label claim that is for effervescent
tablet.
 Provide evidence of drug already approved by DRAP (generic/me-too) with brand
name, registration number and manufacturer as the me-too provided has different
composition than the applied formulation.
Brand Name + Dosage Form + Strength CB SOLE SOLUTION TOPICAL (0.05%)
Composition Each ml contains: -
Clobetasol propionate…...0.5mg
Pharmacological Group Corticosteroid
Type of Form Form 5
Me-too status Gratvate 0.05% Topical Solution of M/s Greater
pharma, Rawalpindi. Registration No. 097577
Remarks of the Evaluator (PEC-XVII)  Topical Lotion (General) Section & Cream/ointment
(General) Section are mentioned in letter No.F.1-
51/2005-Lic (Vol-I) dated 17-07-2019.
 Revise manufacturing outlines as per applied
formulation since minoxidil is mentioned in
manufacturing outlines.
 Firm product Scalpvate liquid (topical lotion),
Clobetasol propionate…0.5mg has been approved in
DRB meeting 316th. Clarification from the firm is
required.
report.
2021 & 13-07-2021.
 Evidence of approval of requisite manufacturing facilities/section by Licensing
division for topical solution preparation.
 Revision of manufacturing outlines as per applied formulation since minoxidil is
mentioned in manufacturing oultines submitted by the firm.
 Clarification from the firm is required as the product Scalpate liquid (topical lotion)
with same composition (Clobetasol propionate….0.5mg) as that of the applied
product has been approved in 316th meeting of Registration Board, in the name of
M/s Derma Techno Pakistan, Lahore.
Brand Name + Dosage Form + Strength CB SOLE-S LOTION
Composition Each ml contains: -
Clobetasol propionate…...0.5mg
Salicylic acid…………….20mg
Pharmacological Group Corticosteroid / antibacterial
Type of Form Form 5
Me-too status Clobetred-S
Each ml contains: -
Clobetasol ...... 0.525mg
Salicylic Acid .... 20mg) of Mass pharma, Lahore.
Remarks of the Evaluator (PEC-XVII)  Topical Lotion (General) Section & Cream/ointment
(General) Section are mentioned in letter No.F.1-
51/2005-Lic (Vol-I) dated 17-07-2019.
 Revise manufacturing outlines as per applied
formulation since betamethasone valerate is mentioned
in manufacturing outlines.
reference regulatory authorities which were
declared/adopted by the Registration Board in its 275th
meeting.
number and manufacturer as the me-too provided has
different composition than the applied formulation.
report.
2021 & 13-07-2021.
authorities/agencies which were adopted by the Registration Board in its 275 th
meeting.
status) alongwith registration number, brand name and name of firm me-too
provided has different composition than the applied formulation.
 Evidence of approval of requisite manufacturing facilities/section by Licensing
division for topicla solution preparation.
 Revision of manufacturing outlines as per applied formulation since Betamethasone
valerate is mentioned in manufacturing oultines submitted by the firm.
b. Deferred Cases
690. Name and address of manufacturer/ M/s ZAFA Pharmaceutical Laboratories (Private)
Applicant Limited, L1/B Block-22 Federal B Industrial Area,
Karachi.
Brand Name + Dosage Form + Strength TRIMEZAT Oral Suspension (24mg/5ml)
Trimebutine…….24mg
Diary No. Date of R & I & fee Dy.No. 254 dated 21-05-2011, Fee Rs: 8,000/- dated
21-05-2011 vide Challan Dated 10-05-2011 (Challan
photocopy),
Dy.No. 1210 dated 10-01-2019, Differential fee: Rs.
12,000 Dated 09-01-2019 vide deposit slip No.
0730282 dated 02-01-2019 (original).
group
Type of Form Form-5
Approval status of product in Reference MODULON CHILD AND INFANT 4.8 mg / ml,
Regulatory Authorities granulated (granules composition per 100 g
>trimebutine: 0.7870 g) for oral suspension in vial.
ANSM approved
Me-too status Tributine Suspension (trimebutine maleate). Reg. No.
031964 (tributine 0.48gm/100ml or 24mg/5ml)
GMP status GMP certificate dated 25-08-2022 based on evaluation
Remarks of the Evaluator (PEC-IX)  The me-too product contains trimebutine maleate,
while the international product contains trimebutine.
 The firm revised the formulation from ‘powder for
suspension’ to ‘granules for suspension’.
 The firm was asked to provide complete finished
product specification and testing method. However,
the firm did not submit the same.
Decision of 288th meeting of Registration  Deferred for following:
Board (14-15th Feb,2019)
of firm.
 Submission of complete finished product specification

and testing method including dissolution test and
content uniformity test.
 Submission of fee for revision of formulation.
 Consideration on its turn.
Remarks of the Evaluator (PEC-XVII)  The firm has claimed manufacturer specifications.
Official monograph not available.
 Dry Powder Suspension (General) Section approved
vide DML renewal letter No.F.2-11/2002-Lic (Vol-I)
dated 26-05-2022.
 The approval status in ANSM is either archived or
repealed.
 Firm provided generic/me-too evidence as Debridat

Oral Suspension (Each 100ml contains:
Trimebutine….0.48gm) of M/s Zafa Pharmaceutical
Labs (Pvt.) Ltd. Karachi. Registration No.016064.

2021 & 13-07-2021.
authorities which were adopted/declard by Registration Board in its 275 th meeting as the
approval status in ANSM France is either arhived or repealed.
Case No. 3: Registration applications for local manufacturing of (Veterinary) drugs.

(Differential fee)
a; New cases:
Brand Name + Dosage Form + Strength LEVAMARS 1.5% Oral Suspension
Levamisole Hydrochloride………15gm
Carrier Q.S to…………………….1000ml
Diary No. Date of R & I & fee Form- 5, Dy. No.248 dated 28-05-2011
Rs.8000/- dated 28-05-2011 (original)
Dy.No.377-R&I (DRAP) dated 04-05-2016,
Differential fee Rs.12000/- dated 04-05-2016 vide
Challan No.0551828 dated 03-05-2016.
(Original Dossier)
Pharmacological Group Anthelmintic/dewormers
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, 5 litres, De-controlled
Approval status of product in Reference Not applicable
Me-too status Levami 1.5% suspension (Levamisole HCl…...1.5%)
of M/s Inshal Pharma, Rawat, Islamabad. Registration
No.075757
Levamit Drench (Oral Drench), Each ml contains
levamisole HCl…15mg Wimitis pharmaceuticals,
Lahore. RegistrationNo.078333
Levomex Drench (Oral Drench) Levamisole
HCl….1.5%, Hawk Biopharma, Rawalpindi.
Registration No.078391
Remarks of the Evaluator (PEC-XVII)  In response to deficiency letter No.F.1-1/2017/PEC-
DRAP (AD PEC-V) dated 23rd November, 2018, you
vide letter No. ZPF/Inch (PEC)/001/DRAP/2019,
dated nil specified the proposed route of
administration as “oral suspension”, revised the
master formulation by replacing the coloring agent
from tartrazine yellow to Parrot green and excluded
the 2% overage of Levamisole hydrochloride in
master formulation. It is therefore advised to submit
the requisite fee accordingly.
 The finished drug product specifications such as assay

and identification are given as per B.P monograph for
“Levamisole oral solution”, while the applied
formulation is “Oral Suspension”. Please clarify?

Decision: Approved with BP specifications and revised label claim as:
Each 1000ml oral solution contains:
Levamisole hydrochloride…….15gm.
Registration letter shall be issued upon submission of following documents:
composition (correction/change of formulation from suspension to solution), as per
Brand Name + Dosage Form + Strength LEVAMARS 15% Oral Solution
Composition Each 1000ml oral solution contains:
Challan No.0551819 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Me-too status SB Levonex oral solution (Levamisole HCl…...15%
w/v) of M/s SB Pharma Islamabad. Registration
No.029630
Remarks of the Evaluator (PEC-XVII)  In initial and differential fee challans, product
mentioned is “Oral suspension”, while in cover letter,
Form-5 and enclosures, the product mentioned is
“Oral solution”.
 Tartrazine yellow color is mentioned in master

formulation, which is not permissible.
 The assay limits given as “90-110%”, while as per BP

Veterinary monograph for Levamisole oral solution,
the limits are “92.5-107.5%.
conducted For above revisions, submit applicable fee
as per notifications 7-11/2012-B&A/DRAP dated 07-
05-2021 & 13-07-2021.
Decision: Approved. Registration letter shall be issued upon submission of following:
composition (correction/change of formulation from suspension to solution), as per
Brand Name + Dosage Form + Strength LEVOXINID Oral Suspension
Oxyclozanide…………………….30gm
Challan No.0551833 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Me-too status Alinil suspension of M/s Alina Combine Pakistan,
Karachi. Registration No.025364
Getzan Drench of M/s Guyton pharmaceuticals,
Lahore. Registration No.039904
Remarks of the Evaluator (PEC-XVII)  In initial fee challan, the product mentioned is “Oral
solution”, while in differential fee challan, Form-5
and enclosures, the product mentioned is “Oral
suspension”. Please clarify?
 Tartrazine yellow color is mentioned in master

formulation, which is not permissible.
 Both APIs are added in 2% excess as overage, in

master formulation.
 The identification and assays methods are provided as

per BP Vet individual monographs for Levamisole
oral solution and oxyclozanide oral suspension.

2021 & 13-07-2021.

correction/change of master formulation without overage, product specifications as
Brand Name + Dosage Form + Strength LEVOXY GOLD (Oral Solution)
Composition Each 1000ml solution contains:
Levamisole Hydrochloride………30gm (3%)
Oxyclozanide…………………….60gm (6%)
Cobalt Sulphate…………………...7.64gm (0.764%)
Sodium Selenite………………….0.76gm (0.076%)
Challan No.0551831 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Me-too status Leox DS Plus suspension
Each 100ml contains: -
Levamisole HCl … 03.00%.
Cobalt sulphate … 0.764 %
Sodium selenate …. 0.076%.
Oxyclozanide …. 06.00%.
M/s Elko organization Pvt ltd. Karachi.
Helmex gold drench

Each ml contains; -
Levamisole hcl….30mg
Oxyclozanide….60mg
Cobalt sulphate…...3.34mg
Sodium selenite….1.00mg
Selmore pharmaceuticals, Lahore
dated nil, specified the proposed route of
administration as “oral solution”, revised the master
formulation by replacing the coloring agent from
tartrazine yellow to Parrot green and has also revised
the label claim/composition as follows:
Each 1000ml solution contains:
Cobalt Sulphate…………………...3.34mg/ml
Sodium Selenite………………….1.00mg/ml
 In differential fee challan, the product mentioned as
“Levoxy gold oral suspension”.
 The finished drug product specifications claimed as

per BP but could not be confirmed in BP.

2021 & 13-07-2021.
Cobalt Sulphate…………………...3.34mg/ml
Sodium Selenite………………….1.00mg/ml
composition (correction/change of quantities of the drug substance), as per
Brand Name + Dosage Form + Strength LEVATRIC (Oral Suspension)
Levamisole Hydrochloride………15gm (1.5%)
Triclabendazole………………….50gm (5%)
Carrier Q.S to……………………. 1000ml
Challan No.0551829 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Me-too status Proven drench
Each ml contains: -
Triclabendazole…50 mg
Levamisole……. 37.50 mg
Mylab (pvt) ltd. Bahawalpur
Registration no.073903
Faguzol oral suspension

Each ml contains:
Triclabendazole…........50mg
Levamisole as HCl …...37.5mg
M/s. Farm aid group, Hattar Industrial Estate, Haripur.
Triclasole plus oral liquid

Levamisole………3.75gm
M/s. Baariq pharmaceuticals,
sunder industrial estate, Sunder raiwind road,
Lahore.
Vamisol-t suspension
Triclabendazole….5g
Levamisole………3.75g
M/s. Univet pharmaceuticals, Rawalpindi.
dated nil, specified the proposed route of
administration as “oral suspension”, revised the
master formulation by replacing the coloring agent
from tartrazine yellow to Parrot green, excluded the
2% overage of APIs in master formulation and has
also revised the label claim/composition as follows:
Levamisole …………37.5gm
Triclabendazole…………50gm
 The finished drug product specifications claimed as per
BP but could not be confirmed in BP.
& 13-07-2021.

Levamisole …………37.5gm
Triclabendazole…………50gm
Brand Name + Dosage Form + Strength ENCOL (Oral Solution)
Composition Each 1000ml Oral Solution contains:
Enrofloxacin …...………100gm
Colistin Sulphate……….50MIU
Carrier Q.S to……………………. 1000ml
Challan No.0551827 dated 03-05-2016.
(Original Dossier)
Pharmacological Group Antibiotic/Antibacterial
Type of Form Form 5
Finished Product Specification Manufacturer specifications
Me-too status I-Enrocol-C Oral Solution (Each 100ml contains: -
Enrofloxacin HCl.…10gm
Colistin Sulphate…50,000,000IU or 50MIU M/s
international pharma Lahore. Registration No.082811
vide letter No. ZPF/Inch (PEC)/005/DRAP/2019, dated
nil, revised the label claim/composition as:
 As per enclosure 7, the finished drug product
specifications (manufacturer) are provided for your
registered drug product Enromars 20% (Oral solution)
is mentioned. Please clarify and provide the finished
drug product specifications for the applied formulation.
& 13-07-2021.
Brand Name + Dosage Form + Strength OXFENDAMARS DRENCH (Oral Suspension)
Composition Each 1000ml Oral Suspension contains:
Oxfendazole …...…………22.65gm (2.265%)
Challan No.0551825 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Finished Product Specification BP specifications
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, De-controlled
Me-too status Oxavet suspension of M/s Medi Vet, Lahore
Oxezole Drench of M/s Islamabad Pharmaceutical
Products, Islamabad. Registration No.16233
 At enclosure 4 regarding manufacturing outlines, in the
master formula table, the firm has mentioned
Albendazole.
& 13-07-2021.
Decision: Approved with BP specifications. Registration letter shall be issued upon
 Revised manufacturing outlines (enclosure 4 of the registration application) with
correct master formula as albendazole mentioned instead of oxfendazole.
 Firm shall submit the fee of Rs. 30000 for variation in registration application i.e.,
correction/change of pharmacological group and correction of above point, as per
Brand Name + Dosage Form + Strength LOXYMARS (Water soluble powder)
Lincomycin HCl BP…...88gm
Spectinomycin BP…….88gm
Amoxycillin Trihydrate BP….200gm
Vitamin E BP…...5gm
Challan No.0551822 dated 03-05-2016.
(Original Dossier)
Pharmacological Group Antibiotic/antibacterial
Type of Form Form 5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1000gm, De-controlled
 In initial fee challan and cover letter, the drug product
name mentioned as “Doxymars (water soluble powder),
while in original Form-5, including its enclosures and
differential fee challan, the drug product name is
mentioned as “Loxymars”.
 Provide evidence of drug already approved by DREAP
(Generic/Me-too) for the applied formulation along
with brand name, registration number and manufacturer
name.
 Firm has claimed BP specifications. However, product
monograph could not be confirmed in BP.
 Clarification from the firm as in the initial fee challan and cover letter, the drug
product name mentioned as “Doxymars (water soluble powder), while in original
Form-5, including its enclosures and differential fee challan, the drug product name
is mentioned as “Loxymars”.
 Firm has claimed BP specifications for drug product. However, product monograph
could not be confirmed in BP.
 Requisite manufacturing facility (penicillin)
Brand Name + Dosage Form + Strength DT300+C (Water soluble powder)
Doxycline HCl…...200gm
Colistin Sulphate….500MIU
Challan No.0551821 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Finished Product Specification USP specifications
Me-too status AVI-TDC oral powder of M/s Avicenna Laboratories,
Sheikhupura. Registration No.071047
TDC-80 Oral powder of M/s Kohinoor Industries,
Sahiwal. Registration No. 080965
Remarks of the Evaluator (PEC-XVII)  Firm has claimed USP specifications but product
official monograph not available in USP.
 Evidence of approval of requisite manufacturing
facilities is required.
 In finished drug product specifications table,
Bromhexine HCl is mentioned.
Brand Name + Dosage Form + Strength FLOMARS (Oral solution)
Composition Each 1000ml solution contains:
Florfenicol…...230gm
Challan No.0551818 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml,5 Litres, De-controlled
Me-too status Flotin liquid of M/s D-Maarson Pharmaceuticals,
Floricent Oral liquid of M/s Decent Pharma, Islamabad.
Fentin-23 oral liquid of M/s Nawal pharmaceuticals,
Taxila Rawalpindi. Registration No.078257
Fenicol liquid of M/s Univet Pharmaceuticals,
Remarks of the Evaluator (PEC-XVII)  The initial challan and cover letter attached bearing
the product name as “Albendamars 10% (Oral
suspension). Clarification is required.
 In response to deficiency letter No.F.1-1/2017/PEC-

dated nil, had revised the label claim/composition as
follows:
Florfenicol…...230gm
 You had claimed BP specifications while official
monograph of the product could not be confirmed.
 Provide most recent GMP compliance inspection
report.

2021 & 13-07-2021.
 Clarification from the firm as in the initial fee challan and cover letter attached
bearing the product name as “Albendamars 10% (Oral suspension).
Brand Name + Dosage Form + Strength ALBENDAMARS 2.5% (Oral suspension)
Albendazole…........25gm
Challan No.0551830 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml,5 Litres, De-controlled
Me-too status Hanzole 2.5% oral suspension of M/s D-Haans
Pharmaceuticals, Azad Kashmir. Registration
No.102251
Zolatin Oral suspension of M/s Aamster laboratories,
 In response to deficiency letter No.F.1-1/2017/PEC-
dated nil, had revised the master formula by replacing
tartrazine with parrot green coloring agent and
excluded the overage.
 You have claimed BP specifications for the finished
drug product but analytical testing methods are not
provided as per BP Monograph.

report.

2021 & 13-07-2021.
Brand Name + Dosage Form + Strength TYRODOXIN (Water soluble powder)
Doxycycline HCl BP…………...200gm
Tylosin tartrate BP…………….100gm
Colistin sulphate BP……………… 500MIU
Bromhexine HCl BP……………... 5gm
Phenyl Butazone BP………………12gm
Carrier QS to …...1000gm
Challan No.0551823 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Finished Product Specification USP specifications
Me-too status Tycoli powder.
Each 100gm contains: -
Tylosin tartrate B.P (vet) 10gm.
Doxycycline HCl B.P (vet) 20gm.
Colistin sulphate B.P (vet) 500MIU.
Bromohexine B.P (vet) 5gm.
Phenyl butazone B.P (vet) 12gm.
(anthelmints). Alina Combine pharmaceuticals (pvt)
ltd., karachi. Registration no. 048294
GMP status
Remarks of the Evaluator (PEC-XVII)  Provide evidence of already approved product for the
applied formulation (Me-too) as the provided Me-too
products formulation are different than the applied
formulation.
 You have claimed USP specifications, but the official
monograph could not be confirmed in USP.

report.

 Review of applie dfromulation by Expert Working Group.
status) alongwith registration number, brand name and name of firm as the
generic/me-too provided has different composition than the applied product.
 Revision of finished drug specifications as official monograph could not be confirmed
in USP while the firm has claimed USP specifications for applied product.
Brand Name + Dosage Form + Strength LACTRUM DS (Water soluble powder)
Lancomycin HCl BP…………...100gm
Colistin sulphate BP……………… 800.000 MIU
Challan No.0551824 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Me-too status Elistine powder
Each gm contains: -
Lincomycin HCl……….........100mg
Colistin sulphate……800,000IU
M/s Elegance pharmaceuticals,
Distt. Rawalpindi.
Tinocin powder
Each gm contains: -
Lincomycin HCl…................100mg
Colistin sulphate…......800,000IU
M/s. Bio-labs (Pvt) ltd.,
Islamabad.
Registration no.103974
GMP status
Remarks of the Evaluator (PEC-XVII)  The initial fee challan and cover letter attached
bearing the product name as “Zactrum DS suspension
while in differential fee challan, Form-5 and its
enclosures, the product mentioned is “Lactrum DS
(Water soluble powder).
 Provide evidence of already approved product for the
applied formulation (Me-too) as the provided Me-too
products formulations are different than the applied
formulation.
 The quantity of Colistin Sulphate mentioned as
800.000MIU and 800,000 MIU in different sections
of the dossier. Clarification is required in this regard.
 The firm has claimed BP specifications, but the same

could not be confirmed in BP.
 Manufacturing outlines are not provided.

2021 & 13-07-2021.
 Clarification from the firm required as in the initial fee challan and cover letter, the
product mentioned as “Zactrum DS Suspension”, while in differential fee challan,
Form-5 and its enclosures, the product mentioned as “Lactrum DS (Water soluble
powder)”. Moreover, the firm has also applied for registration of “Zactrum
suspension” for human use, having composition Trimethoprim……40mg/5ml,
Sulphamethoxazole……200mg/5ml mentioned at Sr.No. 1164.

status) alongwith registration number, brand name and name of firm as the
generic/me-too provided has different composition than the applied product.
 Revision of finished drug product specifications as official monograph could not be
confirmed in BP, while the firm has claimed BP specifications.
Brand Name + Dosage Form + Strength FIPLOXIN (Water Soluble Powder)
Florfenicol…………...230gm
Oxytetracycline as Hydrochloride…….230gm
Carrier QS to …...1000gm
Challan No.0551820 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Me-too status FLOWIM ORAL POWDER
Each Kg contains: -
Oxytetracycline…………150gm
Florfenicol…………….…150gm
M/s. Wimits Pharmaceuticals,
CLOXYFEN WATER SOLUBLE POWDER

Each gm contains: -
Florfenicol………………...150mg
Oxytetracycline HCl…...150mg
M/s. Fizi Pharmaceuticals and Chemical laboratories,
Lahore.
FLO-OTC WATER SOLUBLE POWDER

Each 100g contains: -
OxytetracyclineHCl…15gm
Florfenicol………………...15gm
M/s. D-Haans Pharmaceuticals, Azad Kashmir.
GMP status
Remarks of the Evaluator (PEC-XVII)  The initial challan and cover letter attached bearing
the product name as “Ciploxin (Oral Solution), while
in differential fee challan, Form-5 and its enclosure,
the product mentioned is “Fiploxin (water soluble
powder).
 The Form 5 has also been attached with finished

product specifications for Tilmars (Oral solution).
 You have claimed BP specifications for the applied
formulation but the same could not be confirmed in
BP.

 Clarification from the firm is required since in the initial challan and cover letter, the
product name mentioned as “Ciploxin (Oral Solution), while in differential fee
challan, Form-5 and its enclosure, the product mentioned is “Fiploxin (water soluble
powder).
 Finsiehd drug product specifications provided is for Tilmars oral solution.
Brand Name + Dosage Form + Strength CLOFENDA (Oral Suspension)
Oxfendazole…………...22.600gm
Oxyclozanide………….60gm
Carrier QS to …...1000ml
Challan No.0551832 dated 03-05-2016.
(Original Dossier)
Type of Form Form 5
Pack size & Demanded Price 100ml, 250ml, 500ml, 1000ml, 5 Litres, De-controlled
Me-too status Rumenil Drench
Each ml contains: -
Oxyclozanide…….……62.5mg
Oxfendazole…………...22.5mg
M/s. Mylab (pvt) ltd, Bahawalpur.
Oxazide suspension
Oxyclozanide ….……6.250gm
Oxfendazole ……...….2.265gm
M/s Moreno Iglisias research laboratories (pvt) ltd.,
Oxfendanid oral liquid

Each ml contains: -
Oxfendazole …22.65mg
Oxyclozanide …62.5mg
M/s. Bio-oxime pharmaceuticals, Faisalabad.
Oxyzan suspension
Oxfendazole……….2.265g
Oxyclozanide…….6.25g
M/s. Univet pharmaceuticals, Rawalpindi.
Oxarex drench.
Each ml contains: -
Oxfendazole 22.65mg.
Oxyclozanide 62.50mg.
Star laboratories (pvt) ltd., Lahore.
dated nil, had revised the master formula by replacing
tartrazine with parrot green coloring agent, excluded
the overage and revised composition/label claim as;
Oxfendazole…….22.65gm
Oxyclozanide…….62.5gm
 You have claimed BP specifications for the finished
drug product but the same could not be confirmed in
BP.
2021 & 13-07-2021.

Oxfendazole…….22.65gm
Oxyclozanide…….62.5gm
composition (correction/change of quantities of API), as per notification No.F.7-
11/2012-B&A/DRAP dated 13-07-2021.
Item No. XVI: Agenda of Evaluator-III
Case No. 01 Registration applications of New section / New License
Case No. 01: M/s Biogen Life Sciences, 8Km, Chakbeli Road Rawat, Rawalpindi
M/s Biogen Life Sciences, Rawalpindi has been granted new license (DML No. 000911) by way of
formulation by Licensing division DRAP dated 13-02-2020. Now the firm has submitted following
applications as per the details mentioned in the table below:
Name of Section Considered till 317th RB Freshly applied

meeting
No of No of products No of No of
molecules molecules products
Dry Vial section (Cephalosporin) 03 12 - -
Dry suspension section 01 02 - -
(Cephalosporin)
Capsule section (Cephalosporin) 02 02 - -
Ampoule Section SVP (General) 05 07 - -
Capsule section (General) 03 05 - -
Dry Vial section (General) 03 04 - -
Soft gel capsule general section 02 03 - -
Hydrocortisone injection (steroid) 01 03 - -
Sachet section (General) 01 01 - -
Dry Vial section (Carbapenem) 02 03 - -
Cream section (general) 02 02 - -
Ointment section (General) 01 01 - -
Lotion section (General) 01 01 - -
Infusion Section (General) 02 02 - -
Tablet (General) Section - - 01 01
Tablet (General) Section: 01 Molecule / 01 Product
706. Name, address of Applicant / Marketing M/s Biogen Life Sciences, 8Km, Chakbeli Road
Authorization Holder Rawat, Rawalpindi
Name, address of Manufacturing site. M/s Biogen Life Sciences, 8Km, Chakbeli Road
Rawat, Rawalpindi
Status of the applicant ☒ Manufacturer
☐ Importer
☐ Is involved in none of the above (contract giver)
GMP status of the firm Firm has been granted new license (DML No.
000911) by way of formulation dated 13-02-2020.
Evidence of approval of manufacturing facility Firm has submitted copy of section approval letter
dated 14-02-2020 which specifies Tablet section
(General).
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. 5414: 25-02-2022
Details of fee submitted PKR 30,000/-: 30-12-2021
The proposed proprietary name / brand name MOXIGEN 400mg Tablet
Strength / concentration of drug of Active Each Film coated tablet contains:
Pharmaceutical ingredient (API) per unit Moxifloxacin as HCl………400mg
Pharmaceutical form of applied drug Yellow Colored, oblong, biconvex film coated
tablets
Pharmacotherapeutic Group of (API) Fluoroquinolone antibiotic
Reference to Finished product specifications USP
Proposed Pack size As per SRO
Proposed unit price As per SRO
The status in reference regulatory authorities Avelox 400 mg Tablet (MHRA Approved)
For generic drugs (me-too status) Avelox Tablet by Bayer
Name and address of API manufacturer. Shree Je Laboatory Pvt. Ltd. C-24 & 25 RIICO
Industrial Area, Sotanala, Behror, District Alwar,
Rajasthan India.
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD
template. Firm has summarized information
related to nomenclature, structure, general
properties, solubilities, physical form,
manufacturers, description of manufacturing
process and controls, impurities, specifications,
analytical procedures and its validation, batch
analysis and justification of specification,
reference standard, container closure system and
stability studies of drug substance and drug
product.
Module-III Drug Substance: Firm has submitted detailed data for drug
substance data related to nomenclature, structure,
general properties, solubilities, physical form,
stability studies of drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches
(Conditions & duration of Stability studies) of drug substance at both accelerated as well as real
time conditions. The accelerated stability data is
conducted at 40°C ± 2°C / 75% ± 5% RH for 6
months. The real time stability data is conducted at
30°C ± 2°C / 65 ± 5% RH for 24 months.
Module-III Drug Product: Firm has submitted data of drug product including
its description, composition, pharmaceutical
development, manufacture, manufacturing process
and process control, process validation protocols,
control of excipients, control of drug product,
specifications, analytical procedures, validation of
analytical procedures, batch analysis, justification
of specifications, reference standard or materials,
container closure system and stability.
Pharmaceutical Equivalence and Comparative Firm has submitted results of pharmaceutical
Dissolution Profile equivalence for all the quality tests for their
product against Moxiget Tablet of Getz Pharma.
Firm has submitted results of CDP studies in three
dissolution medium for their product against
Moxiget Tablet of Getz Pharma.
Analytical method validation/verification of Firm has submitted verification studies of the drug
product substance and the drug product.
Manufacturer of API Shree Je Laboatory Pvt. Ltd. C-24 & 25 RIICO Industrial Area, Sotanala,
Behror, District Alwar, Rajasthan India.
API Lot No. MXYUSU001
Description of Pack
Glass vials
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Frequency Accelerated: 0, 3, 6 (Months)
Real Time: 0, 3, 6 (Months)
Batch No. 001 T-002 T-003
Batch Size 1000 Tablets 1000 Tablets 1000 Tablets
No. of Batches 03
DOCUMENTS / DATA TO BE PROVIDED ALONG WITH STABILITY STUDY DATA
1. Reference of previous approval of applications Biogen Pharmaceutical is a new License facility
with stability study data of the firm (if any) hence no such inspection has been conducted
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory 2019/203) issued by Drugs control Organization,
authority of country of origin. Government of Rajasthan India dated 07-02-2019.
The GMP certificate is valid upto three years from
the date of issue.
3. Documents for the procurement of API with Firm has submitted copy of commercial
approval from DRAP (in case of import). invoice dated 08-03-2021 specifying purchase
of 2.5Kg Moxifloxacin.
Firm has also submitted copy of DHL invoice
number 270400305DTD.
4. Data of stability batches will be supported by Firm has submitted complete record of testing of
attested respective documents like all batches along with raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not applicable. Our HPLC system are not 21 CFR
audit trail reports on product testing compliant.
6. 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 real time
time and accelerated) and accelerated stability chambers.
Evaluation by PEC:
Sr. No Shortcomings communicated Response by the firm

1. Submit data of verification of analytical procedure Firm has submitted report of verification studies of
of drug substance the drug substance from Biogen Life Sciences.
2. Submit stability study data of drug substance till Firm has submitted API stability data till 1 year.
claimed shelf life as per zone IV-A conditions,
since the submitted stability study data is till 1 year
only.
3. Justify why the pharmaceutical equivalence Due to easily Access of the comparator Moxiget
studies were conducted against the comparator 400mg Tab in market that way the firm (Biogen Life
product instead of using innovator / reference Sciences) preform Pharmaceutical Equivalence
product. & Comparative Dissolution studies with
Moxiget 400mg Tablet
Decision: Approved.
 Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months as per the
 Manufacturer shall submit Pharmaceutical Equivalence and Comparative dissolution profile
studies with Innovator product before issuance of registration letter.
Case No. 02 Registration applications on Form5F.
a. New cases of local manufacturing
707. Name, address of Applicant / Marketing M/s Saaaf Pharmaceutical Industries.

Authorization Holder 15-Nowshera Industrial Estate, Risalpur
Name, address of Manufacturing site. M/s Bio-Next Pharmaceuticals Plot No. 50, St No.
S-10, RCCI Industrial Estate Rawat Islamabad.
Status of the applicant ☐ Manufacturer
☐ Importer
☒ Is involved in none of the above (contract giver)
Contract manufacturing agreement dated 21-04-
2017 is submitted
GMP status of the firm Firm has been granted new DML by way of
formulation dated 06-11-2019.
Evidence of approval of manufacturing facility Firm has submitted copy of Section approval letter
dated 06-11-2019 specifying Dry Vial Injection
section (Carbapenem).
☐ Export sale
The proposed proprietary name / brand name SAFENEM 500mg IV Injection
Strength / concentration of drug of Active Each vial contains:
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……..500mg
(Blended with sodium carbonate)
Pharmaceutical form of applied drug Glass vial filled with almost white powder along
with 10ml ampoule of WFI further packed in unit
carton.
Pharmacotherapeutic Group of (API) Carbapenem
Proposed Pack size 1’s
The status in reference regulatory authorities Merrem Injection (USFDA Approved)
For generic drugs (me-too status) Meronem Injection by ICI Pakistan Ltd.
Name and address of API manufacturer. Rajasthan Antibiotics Ltd. Plot No. 619 & 630
RIICO Industrial Area Bhiwadi – District Alwar
Rajasthan India.
product.
Module-III Drug Substance: Firm has submitted detailed data for both drug
conducted at 40oC ± 2oC / 75% ± 5% RH for 6
30oC ± 2oC / 65% ± 5% RH for 36 months.
product against the comparator i.e. Meronem
500mg injection.
Analytical method validation/verification of Firm has submitted report of verification of
product analytical method for the drug substance and drug
product.
Manufacturer of API Rajasthan Antibiotics Ltd. Plot No. 619 & 630 RIICO Industrial Area
Bhiwadi – District Alwar Rajasthan India.
API Lot No. UIMRPS19021
Description of Pack
Glass vial
Batch No. MR-001 MR-002 MR-003
No. of Batches 03
1. Reference of previous approval of applications Not applicable.
with stability study data of the firm (if any)
manufacturer issued by concerned regulatory DC/A-1/WHO-GMP/2020/1961) issued by Drugs
authority of country of origin. control organization, Governmnet of Rajasthan
dated 09-12-2020. The certificate is valid till 26-02-
2022.
3. Documents for the procurement of API with  Firm has submitted copy of Form 6 “License to
approval from DRAP (in case of import). import drugs for clinical trial, examination, test
or analysis” for import of meropenem 3Kg from
M/s Rajasthan Antibiotics Ltd. Plot No. 619 &
630 RIICO Industrial Area Bhiwadi – District
Alwar Rajasthan India issued by AD (I&E)
DRAP field office. The license was issued on 02-
01-2020.
 Firm has submitted copy of commercial invoice
dated 02-01-2020 specifying import of 3Kg
meropenem. The invoice is signed by AD (I&E)
DRAP.
attested respective documents like all batches along with chromatograms, raw data
chromatograms, Raw data sheets, COA, summary sheets, COA and summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail record of product
audit trail reports on product testing testing of HPLC for only single day 01-07-2020.
Evaluation by PEC:
 The applied product to be manufactured by M/s Bio-Next Pharmaceuticals have already been
approved by Registration Board in its 296th meeting based on the data of same trial batches of drug
product as submitted in the instant case. The details of the already approved product in 296th meeting
are as follows:
Applicant firm M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10, RCCI
Industrial Estate Rawat Islamabad.
Manufacturer firm M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10, RCCI
Brand Name MENEPOR 500 mg Injection IV
Batch No. of drug product MR-001 (350 vials), MR-002 (350 vials), MR-003 (350 vials)
Case No. 14
Registration Board meeting 296th meeting of Registration Board held on (8th, 9th & 10th
September 2020)
 The stability data of commercial batches of the same formulation manufactured by M/s Bio-Next
Pharmaceuticals have also already been approved by Registration Board in its 320th meeting based
The details of the already approved product in 320th meeting are as follows:
Applicant firm M/s Gray’s Pharmaceuticals Plot No. 2, Street # N-3, National
Industrial Zone Rawat Islamabad.
Brand Name GRAYNEM 500 mg Injection IV
Batch No. of drug product 21E001 (14084 vials), 21E002 (14084 vials), 21E005 (14084 vials)
Case No. 197
Registration Board meeting 320th meeting of Registration Board held on (29th-31st August, 2022)
 Registration Board in its 321st meeting decided to also accept product development data / stability
data of trial batches manufactured by contract manufacturer.
Decision: Approved.
satisfactory capacity assessment of manufacturing and testing facility of M/s Bio-Next
Pharmaceuticals Plot No. 50, St No. S-10, RCCI Industrial Estate Rawat Islamabad wherein
panel shall also review the testing of drug substance and drug product of applied formulation
as per pharmacopoeial requirements.
708. Name, address of Applicant / Marketing M/s Saaaf Pharmaceutical Industries.
Authorization Holder 15-Nowshera Industrial Estate, Risalpur
☐ Importer
2017 is submitted
☐ Export sale
The proposed proprietary name / brand name SAFENEM 1gm IV Injection
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……..1g
(Blended with sodium carbonate)
Pharmaceutical form of applied drug Glass vial filled with almost white powder along
with 20ml ampoule of WFI further packed in unit
carton.
For generic drugs (me-too status) Meronem Injection by ICI Pakistan Ltd.
Rajasthan India.
product.
product against the comparator i.e. Meronem 1g
injection.
product analytical method for the drug substance and drug
product.
API Lot No. UIMRPS19021
Description of Pack
Glass vial
Batch No. MR-004 MR-005 MR-006
No. of Batches 03
manufacturer issued by concerned regulatory DC/A-1/WHO-GMP/2020/1961) issued by Drugs
authority of country of origin. control organization Governmnet of Rajasthan
2022.
or analysis” for import of meropenem 3Kg from
M/s Rajasthan Antibiotics Ltd. Plot No. 619 &
630 RIICO Industrial Area Bhiwadi – District
Alwar Rajasthan India issued by AD (I&E)
DRAP field office. The license was issued on 02-
01-2020.
meropenem. The invoice is signed by AD (I&E)
DRAP.
data sheets etc.
audit trail reports on product testing testing of HPLC for only single day 01-07-2020.
Evaluation by PEC:
 The applied product to be manufactured by M/s Bio-Next Pharmaceuticals have already been
approved by Registration Board in its 296th meeting based on the data of same trial batches of drug
product as submitted in the instant case. The details of the already approved product in 296th meeting
are as follows:
Applicant firm M/s Bio-Next Pharmaceuticals Plot No. 50, St No. S-10, RCCI
Brand Name MENEPOR 1g Injection IV
Batch No. of drug product MR-004 (350 vials), MR-005 (350 vials), MR-006 (350 vials)
Case No. 15
Registration Board meeting 296th meeting of Registration Board held on (8th, 9th & 10th
September 2020)
 The stability data of commercial batches of the same formulation manufactured by M/s Bio-Next
Pharmaceuticals have also already been approved by Registration Board in its 320th meeting based
The details of the already approved product in 320th meeting are as follows:
Applicant firm M/s Gray’s Pharmaceuticals Plot No. 2, Street # N-3, National
Industrial Zone Rawat Islamabad.
Brand Name GRAYNEM 1g Injection IV
Batch No. of drug product 21E008 (10563 vials), 21E009 (10563 vials), 21E010 (10563 vials)
Case No. 198
Registration Board meeting 320th meeting of Registration Board held on (29th-31st August, 2022)
Registration Board in its 321st meeting decided to also accept product development data / stability data of
trial batches manufactured by contract manufacturer.
Decision: Approved.
 Firm shall state the quantity, in mg, of sodium (Na) in a given dosage of Meropenem, on the
label claim, as recommended by the USP monograph of “Meropenem for injection”.
Pharmaceuticals Plot No. 50, St No. S-10, RCCI Industrial Estate Rawat Islamabad wherein
panel shall also review the testing of drug substance and drug product of applied formulation
as per pharmacopoeial requirements.
709. Name, address of Applicant / Marketing M/s Biogen Pharmaceuticals 8Km, Chakbeli
Authorization Holder Road Rawat, Rawalpindi
Rawat, Rawalpindi
☐ Importer
Firm has submitted copy of contract
manufacturing agreement with applicant firm
dated 25-03-2021.
dated 14-02-2020 which specifies Dry vial section
(General).
☐ Export sale
The proposed proprietary name / brand name COLIGEN Injection 1 MIU (IV)
Strength / concentration of drug of Active Each vial Contains:
Pharmaceutical ingredient (API) per unit Colistimethate sodium………1 MIU
Pharmaceutical form of applied drug Sterile white to yellowish fine powder filled in
transparent glass vials with grey rubber stopper
with an aluminium cap
Pharmacotherapeutic Group of (API) Antibiotic
The status in reference regulatory authorities COLOMYCIN 1 million International Units (IU)
Injection (MHRA Approved)
For generic drugs (me-too status) Colistimethate injection 1 MIU by Mukhtar
Enterprises (Reg #093937)
Name and address of API manufacturer. Hebei Shengxue Dacheng Co. Ltd. No. 50,
Shengxue Road No. 17 Fuqiangxi Road, Luacheng
County, Hebei Province P.R China.
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
product against the comparator Colistimethate
sodium 1MIU Injection.
Manufacturer of API Hebei Shengxue Dacheng Co. Ltd. No. 50, Shengxue Road No. 17
Fuqiangxi Road, Luacheng County, Hebei Province P.R China.
API Lot No. HN190202
Description of Pack
Glass vials
Batch No. T010 T011 T012
No. of Batches 03
manufacturer issued by concerned regulatory HE20190058) issued by CFDA China. The
authority of country of origin. certificate is valid till 14-08-2024.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice
approval from DRAP (in case of import). dated 02-02-2020 specifying import of 0.5Kg
Colistimethate. The invoice is not attested by AD
(I&E) DRAP Field office. The firm has submitted
copy of DHL invoice (Invoice No. 20HS-091) for
the import of drug substance.
attested respective documents like all batches along with raw data sheets, and pictures
chromatograms, Raw data sheets, COA, summary of the petri dishes showing zone of inhibitions
data sheets etc. following the microbial assay.
5. Compliance Record of HPLC software 21CFR & NA
Evaluation by PEC:
 Submit differential fee for the registration of applied product, since the notification for revision of
fee vide SRO No. F.7-11/2012-B&A/DRA was published on 7th May 2021 while this application
was received in R&I section of DRAP after 7th May 2021.
 The submitted data was already approved by Registration Board. The details of already approved
product is as under:
Applicant firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,

Rawalpindi
Manufacturer firm M/s Biogen Pharmaceuticals 8Km, Chakbeli Road Rawat,
Rawalpindi
Brand Name LISTIM Injection 1 MIU (IV)
Batch No. of drug product T010 (500 vials), T011 (500 vials), T012 (500 vials)
Case No. 235
Registration Board meeting 297th meeting of Registration Board.
Decision: Approved.
 Firm shall submit differential fee 25,000/- for the registration of applied product, since the
notification for revision of fee vide SRO No. F.7-11/2012-B&A/DRA was published on 7th May
2021 while this application was received in R&I section of DRAP after 7th May 2021.
 Firm will revise the label claim as per the decision taken by the Board in instant meeting
regarding “Review of Colistimethate for Injection” along with submission of requisite fee for
pre-registration correction/changes of label claim (if required) as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
satisfactory capacity assessment of manufacturing and testing facility of M/s Biogen Life
Sciences, 8Km, Chakbeli Road Rawat, Rawalpindi.
710. Name, address of Applicant / Marketing M/s Biogen Pharmaceuticals 8Km, Chakbeli
Authorization Holder Road Rawat, Rawalpindi
Rawat, Rawalpindi
☐ Importer
dated 25-03-2021.
(General).
☐ Export sale
The proposed proprietary name / brand name COLIGEN Injection 2 MIU (IV)
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
Description of Pack
Glass vials
No. of Batches 03
Evaluation by PEC:

Rawalpindi
Rawalpindi
Case No. 236
Decision: Approved.
regarding Review of Colistimethate for Injection along with submission of requisite fee for pre-
registration correction/changes of label claim (if required) as per notification 7-11/2012-
B&A/DRAP dated 07.05.2021 and 13.07.2021.
711. Name, address of Applicant / Marketing M/s Valor Pharmaceuticals. 124/A Industrial
Authorization Holder Triangle, Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Biogen Life Sciences, 8Km, Chakbeli
Road Rawat, Rawalpindi
☐ Importer
dated 25-03-2021.
(General).
☐ Export sale
The proposed proprietary name / brand name COLIVAL Injection 1 MIU (IV)
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
Description of Pack
Glass vials
No. of Batches 03
Evaluation by PEC:

Rawalpindi
Rawalpindi
Case No. 235
Decision: Approved.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Sciences, 8Km, Chakbeli Road Rawat, Rawalpindi
Name, address of Manufacturing site. M/s Biogen Life Sciences, 8Km, Chakbeli
Road Rawat, Rawalpindi
☐ Importer
dated 25-03-2021.
(General).
☐ Export sale
The proposed proprietary name / brand name COLIVAL Injection 2 MIU (IV)
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
Description of Pack
Glass vials
Stability Storage Condition Real time: 30°C ± 2°C / 65% ± 5%RH
No. of Batches 03
Evaluation by PEC:

Rawalpindi
Rawalpindi
Case No. 236
Decision: Approved.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
713. Name, address of Applicant / Mar keting M/s Biogen Pharma, 8Km Chakbeli Road
Authorization Holder Rawat, Rawalpindi
Name, address of Manufacturing site. M/s Biogen Pharmaceuticals 8Km, Chakbeli Road
Rawat, Rawalpindi
☐ Importer
dated 14-02-2020 which specifies Dry Vial section
(Cephalosporin).
☐ Export sale
The proposed proprietary name / brand name BIOTROXONE 2gm IV Injection
Strength / concentration of drug of Active Each Vial Contains:
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……2g
Pharmaceutical form of applied drug Sterile white to off white / yellowish crystalline
powder filled in transparent glass vials
Pharmacotherapeutic Group of (API) Cephalosporin antibiotic
The status in reference regulatory authorities Ceftriaxone sodium Injection (MHRA Approved)
For generic drugs (me-too status) Rocephin injection by Roche.
Name and address of API manufacturer. Pharmagen Ltd. Kot Nabi Buksh Wala 34-Km,
Ferozepur Road, Lahore.
product.
Firm has also submitted compatibility studies of
the drug product along with the recommended
diluent i.e. water for injection.
Dissolution Profile equivalence for all the quality tests defined in USP
for their product against the comparator i.e. Oxidil
2g Injection of M/s Sami Pharma.
product analytical method for the drug substance.
Firm has submitted report of verification of
analytical method for the drug product.
Manufacturer of API Pharmagen Ltd. Kot Nabi Buksh Wala 34-Km, Ferozepur Road, Lahore.
API Lot No. 00421/002/2019
Description of Pack
Glass vials
Batch No. 001 002 003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate issued
manufacturer issued by concerned regulatory by Additional Director DRAP, Lahore dated 11-01-
authority of country of origin. 2019. The GMP certificate was granted based on
approval from DRAP (in case of import). specifying import of 10Kg Ceftriaxone sodium
(sterile) dated 19-02-2020.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted that their HPLC system is not
audit trail reports on product testing 21 CFR compliant.
Evaluation by PEC:

Rawalpindi
Rawalpindi
Brand Name CARE 2g Injection IV
Batch No. of drug product 001 (400 vials), 002 (400 vials), 003 (400 vials)
Case No. 227
Decision: Approved.
 Firm will submit full fee as per notification 7-11/2012-B&A/DRAP dated 07.05.2021 and
13.07.2021 since the title of the manufacturer has been changed from Biogen Pharmaceuticals
to Biogen Life sciences.
714. Name, address of Applicant / Marketing M/s Wilshire Laboratories (Pvt) Ltd. 124/1-
Authorization Holder Quaid-e-Azam Industrial Estate, Kot Lakhpat
Lahore.
Name, address of Manufacturing site. M/s Wilshire Laboratories (Pvt) Ltd. 124/1-Quaid-
e-Azam Industrial Estate, Kot Lakhpat Lahore.
☐ Importer
GMP status of the firm Firm has submitted copy of GMP certificate issued
based on inspection dated 08-08-2019. The GMP
certificate specifies Dry Powder Injection
(General) Section.
Evidence of approval of manufacturing facility Firm has submitted copy of GMP certificate issued
(General) Section.
☐ Export sale
Dy. No. and date of submission Dy. No 33258 dated 08-12-2021
Details of fee submitted Rs. 30,000/- Dated 21-05-2021
The proposed proprietary name / brand name PETRONEL 2MIU Injection
Pharmaceutical ingredient (API) per unit Colistimethate sodium …… 2MIU
Pharmaceutical form of applied drug Powder for solution for injection
Proposed Pack size 1x1’s
The status in reference regulatory authorities MHRA Approved
For generic drugs (me-too status) Nogotex injection by Nabiqasim
Name and address of API manufacturer. Livzon Group Fuzhou Fuxing Pharmaceutical Co.
Ltd. No. 8 Nangang Road, Jiangyin Industrial
Concentration Zone Fuqing, Fuzhou City Fujian
Province China.
product.
Module-III Drug Substance: Firm has submitted detailed drug substance data
Stability Studies of Drug Substance Firm has submitted stability study data of 3
(Conditions & duration of Stability studies) batches of drug substance at both accelerated as
well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75% ±
5% RH for 6 months. The real time stability data
is conducted at 30°C ± 2°C / 65 ± 5% RH for 24
months.
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 Comparative Firm has submitted pharmaceutical equivalence of
Dissolution Profile their product against the comparator product
Colomycin Injection
Analytical method validation/verification of Firm has submitted analytical method validation

product study reports for drug substance as well as drug
product.
Manufacturer of API Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd. No. 8 Nangang
Road, Jiangyin Industrial Concentration Zone Fuqing, Fuzhou City Fujian
Province China.
API Lot No. CMS1811008
Description of Pack
Clear glass vial
Frequency Accelerated: 0, 1, 2, 3, 6 (Months)
Batch No. 001 002 003
Batch Size 1000 Vials 1000 Vials 1000 Vials
No. of Batches 03
1. Reference of previous approval of applications Not submitted by the firm
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy og DML of the firm
manufacturer issued by concerned regulatory (permit number Min 20160089) issued and
authority of country of origin. available online on NMPA China Website. The
certificate is valid till 21-09-2025.
approval from DRAP (in case of import). specifying import of 3.005Kg Colistimethate
sodium. The invoice is attested by AD (I&E) DRAP
4. Data of stability batches will be supported by Firm has submitted Stability data along-with
attested respective documents like HPLC chromatograms and raw data sheets.
chromatograms, Raw data sheets, COA, summary
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not available
6. Record of Digital data logger for temperature and Firm has submitted record of data logger for
Evaluation by PEC:
Sr. No Observation Response by the firm

1. Submit data in section 3.2.S.4.1 as per the Firm has submitted copies of the Drug substance
guidance document approved by Registration specifications and analytical procedures used for
Board which specifies that “Copies of the Drug routine testing of the Drug substance /Active
substance specifications and analytical Pharmaceutical Ingredient by both Drug substance
procedures used for routine testing of the Drug & Drug Product manufacturer.
substance /Active Pharmaceutical Ingredient by
both Drug substance & Drug Product
manufacturer is required.”
2. Provide verification studies of drug substance Firm has submitted verification studies of drug
from drug product manufacturer in section substance from drug product manufacturer.
3.2.S.4.3.
3. Provide COA of relevant batch of drug substance Firm has submitted COA of relevant batch of drug
which is used in the manufacturing of batches of substance which is used in the manufacturing of
drug product in section 3.2.S.4.4, since COA of batches of drug product having batch number
different batches is provided in this section. CMS1811008.
4. Provide details including batch number, expiry Pharmaceutical equivalence is established by
date and manufacturer of the reference product comparing ingredients of Colistimethate sodium 2
against which pharmaceutical equivalence studies MIU Injection (Powder for solution for injection)
have been carried out. manufactured by “XELLIA PHARMACEUTICAL
APS, DENMARK”. This medicinal product is
authorized in the Member States of the EEA like in
France & UK.
5. Justify why pharmaceutical equivalence studies As this product specification comply with the
does not include complete testing as per USP Pharmacopoeial reference & all parameters verified
monograph. with the product specifications as well. So,
Pharmacopoeial equivalence does not required in
this scope.
6. Provide details in sections 3.2.P.2.6 as per the As no excipient is added with API in manufacturing
CTD guidance document which specifies that process of Drug Product so, compatibility studies
“Compatibility studies for the dry powder for are not required.
injections and dry powder for suspension shall be
performed as per the instructions provided in
individual label of the drug product.”
7. Your manufacturing method specifies that the The reference Product as well as our Product is not
product is lyophilized within the vials after lyophilized.
solution preparation and filling while your
approved manufacturing facility is for dry powder
vial general. Justify where the manufacturing of
applied product was carried out.
8. Justify why your drug product specification does pH and free colistin tests are missed due to
not contain pH and free colistin test as specified typographical mistake. Updated Analytical method
in USP monograph. is provided.
9. The analytical method for drug product contains The Drug Product is analyzed by Bioassay as
bioassay method while the verification studies are mentioned in analytical method but HPLC method
carried out usig HPLC method. Justification is is erroneously added in Verification studies due to
required in this regard. typographical mistake.
10. Provide COA of reference standard actually used Lot No. R07870 of Colistimethate Sodium USP
in the analysis of drug product. Reference standard is used.
11. Provide BMR of three stability batches. Firm has submitted copy of BMR of 3 batches.
Decision: Approved.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
715. Name, address of Applicant / Marketing M/s Wilshire Laboratories (Pvt) Ltd. 124/1-
Authorization Holder Quaid-e-Azam Industrial Estate, Kot Lakhpat
Lahore.
Name, address of Manufacturing site. M/s Wilshire Laboratories (Pvt) Ltd. 124/1-Quaid-
e-Azam Industrial Estate, Kot Lakhpat Lahore.
☐ Importer
(General) Section.
(General) Section.
☐ Export sale
The proposed proprietary name / brand name PETRONEL 3MIU Injection
For generic drugs (me-too status) Nogotex injection by Nabiqasim
Province China.
product.
months.
stability.
Colistimethate sodium 3MIU Injection Pan
Medica
product.
Province China.
Description of Pack
Clear glass vial
Batch No. 001 002 003
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy og DML of the firm
manufacturer issued by concerned regulatory (permit number Min 20160089) issued and
authority of country of origin. available online on NMPA China Website. The
certificate is valid till 21-09-2025.
approval from DRAP (in case of import). specifying import of 3.005Kg Colistimethate
sodium. The invoice is attested by AD (I&E) DRAP
data sheets etc.
Evaluation by PEC:

1. Submit data in section 3.2.S.4.1 as per the Firm has submitted copies of the Drug substance
guidance document approved by Registration specifications and analytical procedures used for
Board which specifies that “Copies of the Drug routine testing of the Drug substance /Active
substance specifications and analytical Pharmaceutical Ingredient by both Drug substance
procedures used for routine testing of the Drug & Drug Product manufacturer.
2. Provide verification studies of drug substance Firm has submitted verification studies of drug
from drug product manufacturer in section substance from drug product manufacturer.
3.2.S.4.3.
3. Provide COA of relevant batch of drug substance Firm has submitted COA of relevant batch of drug
which is used in the manufacturing of batches of substance which is used in the manufacturing of
drug product in section 3.2.S.4.4, since COA of batches of drug product having batch number
different batches is provided in this section. CMS1811008.
4. Provide details including batch number, expiry Pharmaceutical equivalence is established by
date and manufacturer of the reference product comparing ingredients of Colistimethate sodium 2
against which pharmaceutical equivalence studies MIU Injection (Powder for solution for injection)
have been carried out. manufactured by “XELLIA PHARMACEUTICAL
APS, DENMARK”. This medicinal product is
authorized in the Member States of the EEA like in
France & UK.
5. Justify why pharmaceutical equivalence studies As this product specification comply with the
does not include complete testing as per USP Pharmacopoeial reference & all parameters verified
monograph. with the product specifications as well. So,
Pharmacopoeial equivalence does not required in
this scope.
6. Provide details in sections 3.2.P.2.6 as per the As no excipient is added with API in manufacturing
CTD guidance document which specifies that process of Drug Product so, compatibility studies
“Compatibility studies for the dry powder for are not required.
injections and dry powder for suspension shall be
performed as per the instructions provided in
7. Your manufacturing method specifies that the The reference Product as well as our Product is not
product is lyophilized within the vials after lyophilized.
solution preparation and filling while your As per imported API the appearance is “white to
approved manufacturing facility is for dry powder slightly yellow odourless fine powder”
vial general. Justify where the manufacturing of
applied product was carried out.
8. Justify why your drug product specification does pH and free colistin tests are missed due to
not contain pH and free colistin test as specified typographical mistake. Updated Analytical method
in USP monograph. is provided.
9. The analytical method for drug product contains The Drug Product is analyzed by Bioassay as
bioassay method while the verification studies are mentioned in analytical method but HPLC method
carried out usig HPLC method. Justification is is erroneously added in Verification studies due to
required in this regard. typographical mistake.
10. Provide COA of reference standard actually used Lot No. R07870 of Colistimethate Sodium USP
in the analysis of drug product. Reference standard is used.
11. Provide BMR of three stability batches. Firm has submitted copy of BMR of 3 batches.
Decision: Approved.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
716. Name, address of Applicant / Marketing M/s Nabiqasim Industries (Pvt) Ltd. 17/24
Authorization Holder Korangi Industrial Area Karachi.
Name, address of Manufacturing site. M/s Nabiqasim Industries (Pvt) Ltd. 17/24
☐ Importer
certificate specifies Small Volume Lyophilized
Injectable Section.
certificate specifies Small Volume Lyophilized
Injectable Section.
Status of application ☒ New Drug Product (NDP)
☐ Generic Drug Product (GDP)
☐ Export sale
The proposed proprietary name / brand name NOGOTEX Injection 4.5MIU
Pharmaceutical ingredient (API) per unit Colistimethate sodium (lyophilized powder) ……
4.5MIU
Pharmaceutical form of applied drug White color lyophilized cake / powder filled in
vials
The status in reference regulatory authorities Coly-Mycin® M Parenteral 150 mg
colistin base activity USFDA Approved
For generic drugs (me-too status) NA
Province China.
product.
months.
stability.
Colomycin Injection
product.
Province China.
Description of Pack
Clear glass vial
Batch No. 373DS01 373DS02 373DS03
No. of Batches 03
1. Reference of previous approval of applications NA
2. Approval of API/ DML/GMP certificate of API Firm has submitted online copy of manufacturing
manufacturer issued by concerned regulatory license of the firm having permit number 20160089
authority of country of origin. issued by NMPA China. The license is valid till 21-
09-2025.
approval from DRAP (in case of import). specifying import of 1Kg Colistimethate sodium.
The invoice is attested by AD (I&E) DRAP dated
11-09-2020 for batch # CMS2005002.
4. Data of stability batches will be supported by Firm has submitted raw data sheets for calculation
attested respective documents like of results of assay.
data sheets etc.
Evaluation by PEC:
The innovator product Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is approved by
USFDA wherein Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150
mg colistin base activity). As per MHRA and EU approved conversion table for dose of colistimethate
sodium (CMS) 150mg CBA is equivalent to 4500000 (4.5MIU).

1. Provide COA of relevant batch of drug COA of relevant batch of drug substance (Batch No.
substance which is used in the manufacturing of CMS 2005002) used in manufacturing of batches of
batches of drug product in section 3.2.S.4.4, drug product is enclose
since COA of different batches is provided in
this section.
2. Provide details including batch number, expiry Xylistin 4.5 MIU (Colistimethate Sodium 4.5MIU)
date and manufacturer of the reference product reference product use in pharmaceutical equivalence
against which pharmaceutical equivalence studies. Details are as follows:
studies have been carried out. Manufactured By Cipla LTD.
Batch No. L610246
Mfg. Date Jun.21
Exp. Date May 23
3. Justify why pharmaceutical equivalence studies Firm has now submitted pharmaceutical equivalence
does not include complete testing as per USP with complete tests as per USP
monograph.
4. Provide details in sections 3.2.P.2.6 as per the Firm has submitted compatibility studies /In-Use
CTD guidance document which specifies that studies for the Colistimethate sodium injection.
“Compatibility studies for the dry powder for
injections and dry powder for suspension shall
be performed as per the instructions provided in
5. Provide COA of reference standard actuallyFirm has submitted COA of reference standard along
used in the analysis of drug product. with standardization record.
6. Justify why sterility test is not performed during
Trial batches for stability studies were manufactured
stability studies. in Research & Development Department, that’s why
sterility studies were not conducted, however for
Minutes of 323 meeting of Registration Board (6 to 8 December, 2022)
rd th th 500
commercial batches sterility testing will be perform
before QC release as well as on stability studies. Firm
has also submitted the following response:
NabiQasim is the only company that has a highly
automated Lyophilized vial inspection machine and
this facility has 100% non-destructive vial testing
ensuring that oxygen and moisture content is not
present in vials that could lead to degradation of the
active substances causing a loss in efficacy and
quality of the product.
Colistimethate Sodium 4.5 MIU for development
studies was manufactured in the R&D Lab facility by
using an R&D dedicated Lab scale Lyophilizer. As
your good self-ask about sterility testing of
Colistimethate Sodium 4.5 MIU on development
batches, now we have developed a trial batch of
Colistimethate Sodium 4.5MIU in our state-of-the-art
commercial Lyophilized facility and till to date
sterility of product has been found satisfactory.
Finished product Specifications to conduct sterility

testing on Colistimethate Sodium Injection 4.5 MIU
is enclosed for your ready reference for QC
commercial release and stability batches.
Moreover, NabiQasim Industries Private Limited

already manufacturing and marketing Lyophilized
Branded Generic Products as follows:
 Remdesivir 100mg Injection
 Colistimethate Sodium 1MIU
 Colistimethate Sodium 2 MIU
 Colistimethate Sodium 3 MIU
7. Justify how 300 vials batch size is sufficient Please note that actual batch size as per BMR of
enough to complete the accelerated and real time stability batches is 200 vials. Batch size mention on
stability studies of the product. stability summary sheet is 300 vials which was a
typo-error. As per stability protocol 190 vials were
collected for stability studies. Revise stability
summary sheet is enclose for your ready reference.
Justification letter for 200 vials of each batch is
sufficient enough for stability studies.
Total Vials require

Description/Appearance = 01
pH = 01
Loss on Drying = 01
Free Colistin = 01
Bacterial Endotoxin Test = 02
Assay = 02
Total Vials = 08
Total Intervals (Real Time Stability) = 06

Total Vials Required for Real Time Stability Studies
=6*08 =48 vials
Total Intervals (Accelerated Stability) = 02

Total Vials Required for Accelerated Condition
Stability Studies =02*08 =16 vials
Although batch size is of 200 Vials, we place 130

Vials for Real Time condition stability studies and 60
Vials for Accelerated Condition stability studies
which are sufficient enough to conduct stability
studies till proposed shelf life period.
8. Specify where the manufacturing of trial batches Manufacturing of trial batches was carried out in
was carried out including details of the R&D facility having R&D Lab scale lyophilizer
equipment as well as its minimum capcity to equipment and approximately 600 vials can be
justify the sterile solution preparation for 300 lyophilized at a time.
vials.
9. Submit Approval of API/ DML/GMP certificate Firm has submitted online copy of manufacturing
of API manufacturer issued by concerned license of the firm having permit number 20160089
regulatory authority of country of origin, since issued by NMPA China. The license is valid till 21-
the submitted “VAI” inspection report of FDA 09-2025.
does not specify the exact address of
manufacturing site.
10. Provide BMR of three stability batches. Firm has submitted BMR of three stability batches.
Decision: Approved.
regarding “Review of Colistimethate for Injection” along with submission of requisite fee for
B&A/DRAP dated 07.05.2021 and 13.07.2021.
717. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot No. 37, Sector 19,
Authorization Holder Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-
23, Industrial Triangle Kahuta Road Islamabad.
☐ Importer
Copy of agreement for contract manufacturing of
pharmaceutical products between contract giver
and acceptor dated 02-08-2021 is submitted.
GMP status of the firm Firm has submitted copy of GMP certificate of M/s
Vision Pharmaceuticals dated 25-03-2022 based
on inspection dated 11-02-2019. As per the
certificate, it was valid till 09-05-2022.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of renewal of
DML of M/s Vision Pharmaceuticals DML No
000517 dated 07-06-2021. The letter specifies
Liquid Injectable Vial SVP (General) Section.
Firm has also submitted copy of letter dated 09-12-
2021 which specifies that CLB in its 283rd meeting
held on 28th October 2021 also approved renewal
of DML for Liquid Injectable (LVP) General
Section.
☐ Export sale
The proposed proprietary name / brand name JYTHON 200mg/100ml Infusion
Strength / concentration of drug of Active Each vial of 100ml Contains:
Pharmaceutical ingredient (API) per unit Linezolid…..…200mg
Pharmaceutical form of applied drug Liquid infusion
Pharmacotherapeutic Group of (API) Antibacterials for systemic use
Reference to Finished product specifications In-house specs
The status in reference regulatory authorities Zyvox IV (USFDA Approved)
For generic drugs (me-too status) Nezkil Infusion by Continental pharma
Name and address of API manufacturer. Optrix Laboratories Pvt Ltd. Survey No. 145/A &
147, Ramalingampally (V), Bommalaramaram
(M), Yadadri-Bhuvanagiri District Telangana
India.
product.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Dissolution Profile equivalence for their product against Nezkil
infusion of Continental Pharma.
Manufacturer of API Optrix Laboratories Pvt Ltd. Survey No. 145/A & 147, Ramalingampally
(V), Bommalaramaram (M), Yadadri-Bhuvanagiri District Telangana India.
API Lot No. OP-LID/07/18/077
Description of Pack
Glass vials
Batch No. 1018904 1018905 1018906
No. of Batches 03
1. Reference of previous approval of applications Not submitted
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of License Retention
manufacturer issued by concerned regulatory Certificate for License number 3/NG/TS/2015/B/G
authority of country of origin. of M/s Optrix Laboratories Pvt Ltd. The license is
permitted with validity upto 02-06-2025.
3. Documents for the procurement of API with Firm has submitted copy of Clearance certificate
approval from DRAP (in case of import). dated 06-09-2018 specifying import of 50Kg
Linezolid. The clearance certificate is issued by AD
(I&E) DRAP.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not applicable. Our HPLC system are not 21 CFR
audit trail reports on product testing compliant.
Evaluation by PEC:
1. The drug substance manufacturer has specified The drug substance testing was done by UV method
HPLC test for assay of drug substance while the at that time, but currently we are using HPLC
drug product manufacturer has specified UV method for both API and finished product. Revised
method for assay of drug substance. Justify how SOP is submitted by the firm.
drug product manufacturer can adopt different test
for assay method from that recommended by the
drug substance manufacturer.
2. Justify why the pharmaceutical equivalence Pharmaceutical equivalence study was done against
studies were conducted against the comparator Nezkil of continental pharma as it is among brand
product instead of using innovator / reference leaders in Pakistan and registered/approved by
product. Further justify why pharmaceutical DRAP. All tests have been performed.
equivalence does not include all quality tests.
3. Justify why the test for filled volume is not The filled volume test was performed and the test
specified in the specifications of the drug product reports are attached.
although this test is recommended in general
monograph of official pharmacopoeia.
4. Justify why terminal sterilization is not performed Terminal sterilization is performed and also
for the said product although being the method of mentioned in BMR.
choice for sterilization.
5. Justify the pH of the drug product from 4.4 to 5.5 Linezolid infusion batches kept on stability have
since the pH range recommended by the pH almost in the range of 4.6 to 4.8, and this is in
innovator’s product is 4.4-5.2. limit of 4.4 to 5.2,
However, we will Revise the pH limit as according
to innovator specs and will revise the testing SOP.
6. Justify the analytical method for assay testing of As this product is not pharmacopeial, so previously
the drug product which is based on UV method batches were tested according to the method of UV
since the innovator’s product as well as the drug spectrophotometer. Hence, the submitted stability
substance manufacturer specify HPLC method for batches were tested according to the previous
assay test. testing method.
Then, we had shifted to HPLC method effective
from 13-9-2021, for which we have shared the
revised SOP now. We are following this method for
stability studies and stability data of batches tested
according to this method. Revised SOP is attached
 Firm shall submit fee 7,500/- for revision of specifications as per notification No.F.7-11/2012-
 Firm shall submit data of HPLC testing on recently manufactured batches of the applied drug
product before issuance of Registration letter.
satisfactory capacity assessment of manufacturing and testing facility of M/s Vision
Pharmaceuticals (Pvt) Ltd. Plot No. 22-23, Industrial Triangle Kahuta Road Islamabad.
718. Name, address of Applicant / Marketing M/s Martin Dow Limited. Plot No. 37, Sector
Authorization Holder 19, Korangi Industrial Area, Karachi
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot No.
204-205, Industrial Triangle Kahuta Road
Islamabad.
☐ Importer
GMP status of the firm Global pharmaceuticals: GMP certificate issued
on the basis of inspection dated 03-01-2022.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of Grant of
additional section / amendment under DML No
000417 of M/s Global Pharmaceuticals Islamabad
dated 18-12-2017 specifying reallocation of dry
powder injection (carbapenem) section in place of
withdrawn Biotech section (BSF)
Intended use of pharmaceutical product ☒ Domestic sale
☐ Export sale
☐ Domestic and Export sales
The proposed proprietary name / brand name CIMIPEN 500mg/500mg Injection
Pharmaceutical ingredient (API) per unit Imipenem (as monohydrate).……500mg
Cilastatin (as sodium)……………500mg
Pharmaceutical form of applied drug White to pale yellow powder filled in clear glass
vials with grey rubber stopper and blue color flip
off seal
Pharmacotherapeutic Group of (API) Carbapenem antibiotic
The status in reference regulatory authorities Primaxin Injection (USFDA Approved)
For generic drugs (me-too status) Onem Injection of Global Pharmaceuticals
Name and address of API manufacturer. Zhuhai United Laboratories Co., Ltd. No. 2428,
Anji Road, Sanzao Town, Jinwan District, Zhuhai
City Guangdong Province China
product.
5°C ± 3°C for 36 months.
Dissolution Profile equivalence for the quality tests for their product
against Primaxin Injection IV of Merck & Co.
Manufacturer of API Zhuhai United Laboratories Co., Ltd. No. 2428, Anji Road, Sanzao Town,
Jinwan District, Zhuhai City Guangdong Province China
API Lot No. 3951902009
3951903005
Description of Pack
Glass vial
Batch No. 19G096 19G097 19G098
No. of Batches 03
1. Reference of previous approval of applications The firm has referred to previous inspection of
with stability study data of the firm (if any) stability data of the same dosage form on the basis
of which Registration Board in 289th meeting
decided to approve registration of Promig Plus
500mg/20mg Tablet and Promig Plus 375mg/20mg
Tablet.
Inspection date: 14th March, 2019
 The HPLC software is 21 CFR compliant.
 The firm has provided data loggers with stability
chambers.
manufacturer issued by concerned regulatory GD20180909) issued by China Food and Drugs
authority of country of origin. Administration. The certificate is valid till 12-05-
2023.
3. Documents for the procurement of API with 3951902009: Firm has submitted copy of
approval from DRAP (in case of import). commercial invoice cleared dated 27-06-2019
specifying import of 50Kg imipenem and cilastatin
for injection. The commercial invoice is attested by
AD (I&E) DRAP field office.
3951903005:
No evidence of import is submitted for this batch.
sheets, COA and summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not submitted.
Evaluation by PEC:
Firm was communicated the following decision of Registration Board
Registration Board in its 313th meeting considered the case of Imipenem / Cilastatin injection manufactured
by Global Pharmaceuticals, Islamabad wherein the Board decided as under:
“Registration Board deliberated that the commercial batches manufactured by the manufacturer
i.e. Global Pharmaceuticals was not developed and tested as per the USP monograph. Keeping in view the
USP monograph, public assessment report of the innovator product and the data submitted by the firm, the
Board decided to defer the case and advised the manufacturer to perform product development studies
keeping in view the innovator product and product testing and stability studies by complying USP
monograph and submit data upon completion of 6 months stability studies”.
In response the firm has submitted complete new CTD (Form 5F) with new data. The evaluation of newly
submitted data is as under:
Dy. No. and date of submission
Details of fee submitted Fee for revised stability batches not submitted
The proposed proprietary name / brand name CIMIPEN 500mg/500mg Injection
Pharmaceutical ingredient (API) per unit Imipenem monohydrate eq. to
imipenem…………….500mg
Cilastatin Sodium eq. to Cilastatin ……………500mg
For generic drugs (me-too status) Cilapen 500mg Injection of Bosch Pharmaceuticals
Reg No. 048491
Name and address of API manufacturer. M/s ACS DOBFAR S.p.A Viale Addetta 2a/12-3/5 20067
Tribiano, Milano- Italy
Module-II (Quality Overall Summary) Firm has submitted QOS as per WHO QOS-PD template.
Summarized information related to nomenclature, structure,
manufacturers, description of manufacturing process and
controls, impurities, specifications, analytical procedures
and its verification, batch analysis and justification of
specification, reference standard, container closure system
and stability studies of drug substance and drug product is
submitted.
Module III (Drug Substance) The firm as submitted detail of nomenclature, structure,
controls, tests for impurity & related substances,
specifications, analytical procedures and its verification,
batch analysis and justification of specification, reference
standard, container closure system and stability studies of
drug substance
Stability studies Stability study conditions:
Real time: Temp.: 30°C ± 2°C, RH: 65% ± 5% for 36
month
Accelerated: Temp.: 40°C ± 2°C, RH: 75% ± 5%for 6
months
Batches: (990068 8004 2, 990068 8005 2, 990068 8006 2)
Module-III (Drug Product): The firm has submitted detail of manufacturers, description
of manufacturing process and controls, impurities,
specifications, analytical procedure and its verification
studies, batch analysis and justification of specification,
reference standard, container closure system and stability
studies of drug product.
Pharmaceutical equivalence and comparative The Firm has performed pharmaceutical equivalence of
dissolution profile their developed formulation Cinam 500mg injection (B
#22A338) with reference product Cilapen 500mg Injection
Batch No: CP200034 by Bosch Pharmaceuticals. The
results showed that both test and reference products were
comparable.
Analytical method validation/verification of Method verification studies have submitted including
product linearity, range, accuracy, precision, specificity.
Manufacturer of API M/s ACS DOBFAR S.p.A Viale Addetta 2a/12-3/5 20067 Tribiano,
Milano- Italy.
API Lot No. 990068-0008-E1
Description of Pack White to pale yellow color powder filled in clear glass vial, packed in Unit
(Container closure system) carton (1’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 22A337 22A338
Batch Size 5550 vials 5550 vials
Manufacturing Date 01-2022 01-2022
Date of Initiation 22-01-2022 22-01-2022
No. of Batches 02
Administrative Portion
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by Italian
manufacturer issued by concerned regulatory pharmaceutical Agency valid till 26/03/2025 is
authority of country of origin. submitted.
3. Documents for the procurement of API with The firm has submitted copy of invoice for the
approval from DRAP (in case of import). import of and attested ADC (I&E) DRAP,
Islamabad dated 02-06-2021 for Imipenem and
cilastatin sodium sterile Batch No. 990068 0008 E1.
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches
attested respective documents like along with chromatograms, raw data sheets, COA
chromatograms, and summary data sheets.
Raw data sheets, COA, summary data sheets
etc.
5. Compliance Record of HPLC software 21CFR Firm has submitted Compliance Record of HPLC
& audit trail reports on product testing software 21CFR
6. Record of Digital data logger for temperature Firm has submitted record of data logger for
and humidity monitoring of stability chambers temperature and humidity monitoring of real time
(real time and accelerated) and accelerated stability chambers.
Remarks of Evaluator:
 The diluent for reconstitution used by the firm is 10ml WFI while innovator and reference product
recommend 10ml 0.9% NaCl injection.
 Firm is using 1081mg/ vial which is not justified keeping in view both drug substances are
available as salt form where 530mg imipenem monohydrate is equivalent to 500 mg imipenem and
530 mg cilastatin sodium salt is equivalent to 500mg cilastatin. Furthermore, the COA of API
depicts that the maximum percentage of both API could be 96.6% (48.3 % of individual API).
The panel has conducted capacity assessment of the firm, M/s Global Pharmaceuticals on
21.10.2022 for following sections and has submitted report to PE&R Division for further
processing:
1. Dry Powder Injection (Cephalosporin)
2. Dry Powder Injection (Penicillin)
3. Dry Powder Injection (Carbapenem)
4. Liquid Injection Ampoule (General)
Discussion: Registration Board was apprised that the firm has submitted response against the above
mentioned observations on the day of meeting in which firm has submitted that in BMR they have mentioned
10ml WFI as diluent, however from now onwards they will use 10ml 0.9% NaCl solution as diluent as per
the recommendations of innovator’s drug product. Furthermore, the firm has also submitted calculation for
fill weight of drug substance in the vials in which they have taken sodium contents as per innovator’s drug
product claim instead of using sodium contents as per the drug substance.
Decision: Approved.
 M/s Global shall use 10ml 0.9% NaCl injection as diluent for the commercial batches and
submit compatibility study with the 0.9%NaCl solution as diluent along with BMR of recently
manufactured batches from M/s Global Pharmaceuticals, as evidence of use of the
recommended diluent before issuance of Registration letter.
 Firm shall use correct fill weight per vial considering the sodium content as per the drug
substance manufacturer’s claim for the commercial batches and submit BMR of recently
manufactured batches from M/s Global Pharmaceuticals as evidence of correct fill weight
before issuance of Registration letter.
 Firm shall submit full fee 75,000/- for revision of stability study data as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021 along with Pharmaceutical equivalence studies
against the innovator product..
consideration of satisfactory capacity assessment of manufacturing and testing facility of M/s
Global Pharmaceuticals.
719. Name, address of Applicant / Marketing M/s Sigma Pharma International (Pvt) Ltd. Plot
Authorization Holder # E-50, North Western Industrial Zone, Port
Qasim, Karachi.
Name, address of Manufacturing site. M/s Sigma Pharma International (Pvt) Ltd. Plot #
E-50, North Western Industrial Zone, Port Qasim,
Karachi.
☐ Importer
on the basis of inspection dated 12-11-2020. The
letter specifies Tablet (General) Section.
on the basis of inspection dated 12-11-2020. The
letter specifies Tablet (General) Section.
☐ Export sale
The proposed proprietary name / brand name TRED SR 100mg Tablet
Strength / concentration of drug of Active Each film coated sustained release tablet contains:
Pharmaceutical ingredient (API) per unit Tramadol HCl………100mg
Pharmaceutical form of applied drug White color round shaped film coated sustained
release tablet with line of bisection on one side.
Pharmacotherapeutic Group of (API) Analgesic
Proposed Pack size 1 x 10’s
For generic drugs (me-too status) Tramal SR Tablet by Searle
Name and address of API manufacturer. Supriya Lifescience Ltd., A-5/2, Lote Parshuram
Industrial Area, M.I.D.C. Taluka – Khed, District
– Ratnagiri, Maharashtra, India
product.
30°C ± 2°C / 75 ± 5% RH for 12 months.
against the comparator product Tramal SR Tablet
by Searle.
Firm has submitted results of CDP for their
product against the comparator product Tramal SR
Tablet by Searle. The CDP is performed in 3
dissolution medium.
Manufacturer of API Supriya Lifescience Ltd., A-5/2, Lote Parshuram Industrial Area, M.I.D.C.
Taluka – Khed, District – Ratnagiri, Maharashtra, India
API Lot No. SLL/TDM/0121006
Description of Pack
Alu-PVC
Real Time: 0, 6 (Months)
Batch No. T-001 T-002 T-003
Batch Size 6452 Tablet 6452 Tablet 6452 Tablet
No. of Batches 03
1. Reference of previous approval of applications No PSI of the firm has been conducted.
manufacturer issued by concerned regulatory 6099317) issued by Food & Drugs Administration
authority of country of origin. (Maharashtra State) India. The certificate is valid
till 29-04-2022.
approval from DRAP (in case of import). from Globe Chemicals GmbH cleared by AD
(I&E) DRAP dated 22-04-2021. The invoice
declare purchase of 300Kg Tramadol HCl.
4. Data of stability batches will be supported by Firm has submitted stability study data of 3
attested respective documents like batches along with water loss test at each time
chromatograms, Raw data sheets, COA, summary point. Firm has submitted analytical report at each
data sheets etc. stability testing interval.
5. Compliance Record of HPLC software 21CFR & HPLC system is not 21 CFR compliant
Evaluation by PEC:
 Firm has submitted initial application on Form 5F on 20-11-2019 before the start of process of CTD
pre-submission screening. The initial application was without any product development or stability
study data. Later in response to the letter of shortcoming the firm submitted product development
and stability study data on 05-10-2021.
 The real time stability study data of API is till 12 months only.
 GMP certificate of API was valid till 29-04-2022.
 Real time stability study data was conducted at 0, 6, 12, 18, 24 month and does not include testing
at 3 and 9 months.
Decision: Registration Board observed that the firm has submitted various documents at different
time intervals and that completely compiled application is not submitted. The Board after thorough
deliberation decided to defer the case for submission of complete application on Form 5-F as per the
guidance document approved by Registration Board.
720. Name, address of Applicant / Marketing M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33,
Authorization Holder Sundar Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s English Pharmaceutical Industries Link
Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore.
☐ Importer
dated 28-05-2021.
GMP status of the firm English Pharmaceutical: GMP certificate issued
Evidence of approval of manufacturing facility Firm (M/s English Pharmaceuticals) has submitted
copy of renewal of DML letter dated 09-03-2015
specifying Dry powder injectable vial (General)
section.
☐ Export sale
The proposed proprietary name / brand name COLIZONE 2MIU Injection
For generic drugs (me-too status) Colistim injection by Biocare pharmaceuticals
Name and address of API manufacturer. M/s Hebei Shengxue Dacheng Pharmaceutical Co
Ltd. No. 50 Shengxue Road Launcheng District
Shijiazhuang Hebei Province, China
product.
Stability Studies of Drug Substance Firm has submitted stability data of 3 batches of
(Conditions & duration of Stability studies) API at accelerated and real time conditions.
stability.
Colixin Injection of Pharmis Biofamaceutica
product.
Manufacturer of API M/s Hebei Shengxue Dacheng Pharmaceutical Co Ltd. No. 50 Shengxue
Road Launcheng District Shijiazhuang, Hebei Province, China
Description of Pack
Clear glass vial
Frequency Accelerated: 0, 1, 3, 6 (Months)
Real Time: 0, 1, 3, 6 (Months)
Batch No. Trial 01 Trial 02
Batch Size 2700 packs 2700 packs
No. of Batches 03
1. Reference of previous approval of applicationsNo previous inspection of the firm has been
with stability study data of the firm (if any)conducted for verification of stability study data.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate (No. HE20190058) issued
manufacturer issued by concerned regulatory by China Food and Drug Administration valid upto
authority of country of origin. 14-08-2024 is submitted
The invoice is attested by AD (I&E) DRAP Lahore
dated 19-11-2018 for batch # HN180401
data sheets etc.
Evaluation by PEC:
The submitted product development and stability study dataof manufacturer is already approved in
320th meeting in Coliate 2MIU Injection case of M/s English Pharmaceuticals Industries. Link Kattar
Bund Road, Thokar Niaz Baig, Multan Road, Lahore.
Decision: Approved.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
satisfactory capacity assessment of manufacturing and testing facility of M/s. English
Pharmaceutical Industries, Link Kattar Bund Road, Thokar Niaz Baig, Multan Road, Lahore.
721. Name, address of Applicant / Marketing M/s Horizon Healthcare (Pvt) Ltd. Plot No. 33,
Authorization Holder Sundar Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s English Pharmaceutical Industries Link
Kattar Bund Road, Thokar Niaz Baig, Multan
Road, Lahore.
☐ Importer
dated 28-05-2021.
GMP status of the firm English Pharmaceutical: GMP certificate issued
Evidence of approval of manufacturing facility Firm (M/s English Pharmaceuticals) has submitted
copy of renewal of DML letter dated 09-03-2015
specifying Dry powder injectable vial (General)
section.
☐ Export sale
The proposed proprietary name / brand name COLIZONE 4.5MIU Injection
Pharmaceutical ingredient (API) per unit Colistimethate sodium …… 4.5MIU
For generic drugs (me-too status) Colistim injection by Biocare pharmaceuticals
Name and address of API manufacturer. M/s Hebei Shengxue Dacheng Pharmaceutical Co
Ltd. No. 50 Shengxue Road Launcheng District
Shijiazhuang Hebei Province, China
product.
Stability Studies of Drug Substance Firm has submitted stability data of 3 batches of
(Conditions & duration of Stability studies) API at accelerated and real time conditions.
stability.
Colixin Injection of Pharmis Biofamaceutica
product.
Manufacturer of API M/s Hebei Shengxue Dacheng Pharmaceutical Co Ltd. No. 50 Shengxue
Road Launcheng District Shijiazhuang, Hebei Province, China
Description of Pack
Clear glass vial
Real Time: 0, 1, 3, 6 (Months)
Batch No. Trial 05 Trial 06
Batch Size 2700 packs 2700 packs
No. of Batches 03
1. Reference of previous approval of applications No previous inspection of the firm has been
with stability study data of the firm (if any) conducted for verification of stability study data.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate (No. HE20190058) issued
manufacturer issued by concerned regulatory by China Food and Drug Administration valid upto
authority of country of origin. 14-08-2024 is submitted
The invoice is attested by AD (I&E) DRAP Lahore
dated 19-11-2018 for batch # HN180401
data sheets etc.
Evaluation by PEC:
 The submitted product development and stability study data of manufacturer is already approved in
320th meeting in Coliate 4.5MIU Injection case of M/s English Pharmaceuticals Industries. Link
Kattar Bund Road, Thokar Niaz Baig, Multan Road, Lahore.
Decision: Approved.
B&A/DRAP dated 07.05.2021 and 13.07.2021.
satisfactory capacity assessment of manufacturing and testing facility of M/s. English
Pharmaceutical Industries, Link Kattar Bund Road, Thokar Niaz Baig, Multan Road, Lahore.
722. Name, address of Applicant / Marketing M/s Daneen Pharma Pvt Ltd. 27, Sundar
Authorization Holder industrial Estate, Sundar Raiwind Road,
Lahore
Name, address of Manufacturing site. M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi
Creek Road, Karachi, 75190, Pakistan
☐ Importer
manufacturing agreement between contract giver
and contract acceptor dated 18-12-2017.
Evidence of approval of manufacturing facility Firm has submitted copy of GMP certificate dated
30-10-2019 which specifies Tablet (General)
section.
☐ Export sale
Details of fee submitted PKR 50,000/-: 26-07-2021 +
PKR 25,000/-: 10-06-2021
The proposed proprietary name / brand name ROXET CR 12.5mg Tablet
Strength / concentration of drug of Active Each enteric, film-coated, controlled-release tablet
Pharmaceutical ingredient (API) per unit contains:
Paroxetine (as hydrochloride)…..12.5mg
Pharmaceutical form of applied drug Green color, round, biconvex enteric coated
tablets, plain from both sides
Pharmacotherapeutic Group of (API) Selective serotonin reuptake inhibitors
Proposed Pack size 10’s, 20’s, 30’s, 50’s, 100’s
The status in reference regulatory authorities Paxil CR Tablet (USFDA Approved)
For generic drugs (me-too status) Paraxyl Tablet by CCL Pharmaceuticals
Name and address of API manufacturer. Zhejiang Haisen Pharmaceutical Co Ltd. Liushi
Street, Dongyang city, Zhejiang Province China.
product.
product against the comparator i.e. Seroxat CR
12.5 mg Tablet.
Analytical method validation/verification of Firm has submitted report of verification studies of
product analytical method of drug substance.
Manufacturer of API Zhejiang Haisen Pharmaceutical Co Ltd. Liushi Street, Dongyang city,
Zhejiang Province China.
API Lot No. 5819031201
Description of Pack Alu-Alu blister
Batch No. 19SB-126-01 19SB-127-02 19SB-130-03
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to onsite inspection report of their
with stability study data of the firm (if any) product “WYMLY Tablets 25mg (Tenofovir
Alafenamide)”, which was conducted on 09-04-
2018, and was presented in 281st 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 observations were reported in the report:
 The HPLC software is 21CFR complaint and
having certificates of compliance by USFDA.
 Audit trail on the testing reports of WYMLY
Tablets 25mg (Tenofovir Alafenamide) is
available.
 Adequate monitoring and control are available
for stability chamber. Chamber are controlled
and monitored through software having alarm
system for alerts as well.
manufacturer issued by concerned regulatory ZJ20180136) issued by China Food and Drug
authority of country of origin. Administration dated 14-11-2018. The certificate is
valid till 13-11-2023.
or analysis” for import of Paroxetine HCl 1Kg
from M/s Zhejiang Haisen Pharmaceutical Co
Ltd. Liushi Street, Dongyang city, Zhejiang
Province China issued by AD (I&E) DRAP field
office. The license was issued on 17-06-2019.
specifying import of 1Kg Paroxetine HCl. The
invoice was signed by AD (I&E) DRAP field
office dated 17-06-2019.
data sheets etc.
audit trail reports on product testing testing of HPLC.
Evaluation by PEC3:
The submitted product development and stability study data of manufacturer is already approved in
297th meeting in Patrox 12.5mg CR Tablet case of M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi
Creek Road, Karachi, 75190, Pakistan.
Decision: Approved. Manufacturer will perform process validation of first three batches as per the
satisfactory capacity assessment of manufacturing and testing facility of M/s Genix Pharma
Pvt Ltd. 44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan.
Lahore
☐ Importer
section.
☐ Export sale
PKR 25,000/-: 10-06-2021
The proposed proprietary name / brand name ROXET CR 25mg Tablet
Paroxetine (as hydrochloride)…..25mg
Pharmaceutical form of applied drug Pink color, round, biconvex enteric coated tablets,
plain from both sides
product.
product against the comparator i.e. Seroxat CR 25
mg Tablet.
API Lot No. 5819031201
Batch No. 19SB-131-01 19SB-132-02 19SB-136-03
No. of Batches 03
available.
data sheets etc.
Evaluation by PEC3:
297th meeting in Patrox 25mg CR Tablet case of M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek
Road, Karachi, 75190, Pakistan.
Lahore
☐ Importer
section.
☐ Export sale
PKR 25,000/-: 10-06-2021
The proposed proprietary name / brand name ROXET CR 37.5mg Tablet
Paroxetine (as hydrochloride)..…37.5mg
Pharmaceutical form of applied drug Blue color, round, biconvex enteric coated tablets,
plain from both sides
product.
product against the comparator i.e. Seroxat CR
37.5 mg Tablet.
API Lot No. 5819031201
Batch No. 19SB-137-01 19SB-138-02 19SB-139-03
No. of Batches 03
available.
data sheets etc.
Evaluation by PEC3:
297th meeting in Patrox 37.5mg CR Tablet case of M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi
Creek Road, Karachi, 75190, Pakistan.
Lahore
☐ Importer
section.
☐ Export sale
PKR 25,000/-: 10-06-2021
The proposed proprietary name / brand name ROXET 20mg Tablet
Strength / concentration of drug of Active Each Film Coated Tablet Contains:
Pharmaceutical ingredient (API) per unit Paroxetine HCl…20mg
Pharmaceutical form of applied drug Square shape pink color, biconvex film coated
tablet engraved GENIX on one side and plain from
other side.
The status in reference regulatory authorities Paxil Tablet (USFDA Approved)
product.
product against the comparator i.e. Seroxat 20mg
Tablet.
Firm has also submitted results of comparative
dissolution profile of their product against Seroxat
20mg Tablet in three dissolution medium.
API Lot No. 5819031201
Description of Pack
Alu-Alu blister
Batch No. 19SB-140-01 19SB-141-02 19SB-142-03
No. of Batches 03
available.
data sheets etc.
Evaluation by PEC3:
297th meeting in Patrox 20mg Tablet case of M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek
Road, Karachi, 75190, Pakistan.
Lahore.
Name, address of Manufacturing site. M/s Genix Pharma (Pvt) Ltd, 44-45-B, Korangi
Creek Road, Karachi
☐ Importer
GMP status of the firm The firm is inspected on 02-07-2020 wherein the
firm was found to be operating at good level of
GMP compliance.
Evidence of approval of manufacturing facility The firm has provided Sachet (General) section
from confirmed from approved layout plan from
licensing division.
☐ Export sale
The proposed proprietary name / brand name POLYCOL Jar 578g Powder for Solution
Strength / concentration of drug of Active Each dose contains:
Pharmaceutical ingredient (API) per unit Polyethylene glycol 3350…………….17g
Pharmaceutical form of applied drug White to off white color powder filled in HDPE
bottle.
Pharmacotherapeutic Group of (API) Osmotic laxative
Reference to Finished product specifications Manufacturer’s specifications
Proposed unit price As per PRC
The status in reference regulatory authorities Miralax for oral solution of M/s Bayer Healthcare
LLC (USFDA Approved, over the counter)
For generic drugs (me-too status) Not available
Name and address of API manufacturer. M/s Avesta Pharma Pvt Ltd., Shivam chambers,
106/108, First Floor, S.V. Road, Goregaon west,
Mumbai–400 062 Maharashtra 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.
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: The firm has submitted detailed drug substance
data related to nomenclature, structure, general
30°C ± 2 °C / 65% ± 5% RH for 36 months.
and process control, process validation protocols
and report, control of excipients, control of drug
stability.
Pharmaceutical Equivalence and Comparative The firm has performed pharmaceutical
Dissolution Profile equivalence and comparative dissolution profile of
Movcol 578g Jar (B#19SB-149-01) and Miralax
578g Jar (B # TN00RM) of M/s Bayer. Quality
tests of both products including description,
identification, filled weight, moisture content and
assay were compared.
product report of applied product.
Manufacturer of API M/s Avesta Pharma Pvt Ltd., Shivam chambers, 106/108, First Floor, S.V.
Road, Goregaon west, Mumbai – 400 062 Maharashtra India.
API Lot No. AP0919009
Description of Pack
HDPE Bottle
Batch No. 19SB-149-01 19SB-150-02 19SB-151-03
Batch Size 50 Bottles 50 Bottles 50 Bottles
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of
manufacturer issued by concerned regulatory M/s. Avesta Pharma Pvt. Ltd, Maharashtra state,
authority of country of origin. India issued by Food and Drug Administration,
Maharashtra state, India. It is valid upto 15-09-
2023.
approval from DRAP (in case of import). import of polyethylene glycol-3350 (5000Kg,
Batch # AP0919009) attested by AD (I & E) DRAP,
Karachi dated 18-04-2019.
chromatograms, Raw data sheets, COA, summary and summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & The firm has submitted compliance record of HPLC
audit trail reports on product testing software from Waters Corporation.
Audit trail of testing of product has not been
submitted.
Evaluation by PEC:
 Submit valid contract manufacturing agreement between the contract giver and contract acceptor.
 Scientific justification of using Jar container closure system instead of using foil pouch as per
reference product i.e., Miralax of M/s Bayer for achieving unit dose dispensing of applied product.
 Evidence of availability of drug product in applied container closure system in reference regulatory
authorities.
 Submit product development and stability study data of commercial batches manufactured by the
drug product manufacturer, since the submitted data are of trial batches.
Decision: Deferred for following submissions:
 Confirmation of required facility where manufacturing and packaging in Jar can be carried
out.
 Clarification how the applied product is similar in terms of packaging material, unit dose and
total dose per pack in comparison with the innovator’s product.
 Evidence of HPLC system along with RI detector which is used for product testing.
 Submission of 25,000/- differential fee for the registration of applied product, since the
 Valid contract manufacturing agreement between the contract giver and contract acceptor.
Lahore.
Name, address of Manufacturing site. M/s Genix Pharma (Pvt) Ltd, 44-45-B, Korangi
Creek Road, Karachi
☐ Importer
GMP status of the firm The firm is inspected on 02-07-2020 wherein the
firm was found to be operating at good level of
GMP compliance.
Evidence of approval of manufacturing facility The firm has provided Sachet (General) section
from confirmed from approved layout plan from
licensing division.
☐ Export sale
The proposed proprietary name / brand name POLYCOL Jar 238g Powder for Solution
Strength / concentration of drug of Active Each dose contains:
Pharmaceutical ingredient (API) per unit Polyethylene glycol 3350…………….17g
Pharmaceutical form of applied drug White to off white color powder filled in HDPE
bottle.
Pharmacotherapeutic Group of (API) Osmotic laxative
Reference to Finished product specifications Manufacturer’s specifications
The status in reference regulatory authorities Miralax for oral solution of M/s Bayer Healthcare
LLC (USFDA Approved, over the counter)
For generic drugs (me-too status) Not available
Name and address of API manufacturer. M/s Avesta Pharma Pvt Ltd., Shivam chambers,
106/108, First Floor, S.V. Road, Goregaon west,
Mumbai – 400 062 Maharashtra India.
manufacturers, Characterization, impurities,
The firm has summarized information of drug
product including its description, composition,
Module-III Drug Substance: The firm has submitted detailed drug substance
30°C ± 2 °C / 65% ± 5% RH for 36 months.
and process control, process validation protocols
and report, control of excipients, control of drug
stability.
Pharmaceutical Equivalence and Comparative The firm has performed pharmaceutical
Dissolution Profile equivalence of Movcol 238g Jar (B#19SB-143-01)
of M/s Genix pharma with Miralax 238g Jar (B #
0C20PU) of M/s Bayer. Quality tests of both
products including description, identification,
filled weight, moisture content and assay were
compared.
product report of applied product.
Manufacturer of API M/s Avesta Pharma Pvt Ltd., Shivam chambers, 106/108, First Floor, S.V.
Road, Goregaon west, Mumbai – 400 062 Maharashtra India.
API Lot No. AP0919009
Description of Pack
HDPE Bottle
Batch No. 19SB-143-01 19SB-144-02 19SB-145-03
Batch Size 50 Bottles 50 Bottles 50 Bottles
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API The firm has submitted copy of GMP certificate of
manufacturer issued by concerned regulatory M/s. Avesta Pharma PVT LTD, Maharashtra state,
authority of country of origin. India issued by Food and Drug Administration,
Maharashtra state, India. It is valid upto 15-09-
2023.
approval from DRAP (in case of import). import of polyethylene glycol-3350 (5000Kg,
Batch # AP0919009) attested by AD (I & E) DRAP,
Karachi dated 18-04-2019.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & The firm has submitted compliance record of HPLC
audit trail reports on product testing software from Waters Corporation.
Audit trail of testing of product has not been
submitted.
Evaluation by PEC:
 Scientific justification of using Jar container closure system instead of using foil pouch as per
reference product i.e., Miralax of M/s Bayer for achieving unit dose dispensing of applied product.
 Evidence of availability of drug product in applied container closure system in reference regulatory
authorities.
drug product manufacturer, since the submitted data are of trial batches.
 Confirmation of required facility where manufacturing and packaging in Jar can be carried
out.
 Clarification how the applied product is similar in terms of packaging material, unit dose and
total dose per pack in comparison with the innovator’s product.
 Evidence of HPLC system along with RI detector which is used for product testing.
 Submission of 25,000/- differential fee for the registration of applied product, since the
 Valid contract manufacturing agreement between the contract giver and contract acceptor.
728. Name, address of Applicant / Marketing M/s Cherwel Pharmaceuticals (Pvt) Ltd. Plot #
Authorization Holder 20, Phase 4, Hattar Industrial Estate Hattar.
☐ Importer
2017 is submitted
☐ Export sale
The proposed proprietary name / brand name IMIPEN Injection 250mg IV
Pharmaceutical ingredient (API) per unit Imipenem as monohydrate…250mg
Cilastatin as sodium…250mg
Pharmaceutical form of applied drug Glass vial filled with white to pale yellow powder
along with 10ml ampoule of 0.9% NaCl solution.
The status in reference regulatory authorities Impenem and cilastatin Injection (USFDA
Approved)
For generic drugs (me-too status) Cilapen Injection by Bosch Pharma
Name and address of API manufacturer. Sun Pharmaceutical Industries Ltd. Industrial Area
3, Dewas, 455001, Madhiya Paradesh India.
product.
product against the comparator i.e. Cilapen 250mg
Injection (IV) of Bosch Pharmaceuticals.
product analytical method for the drug substance and the
drug product product.
Manufacturer of API Sun Pharmaceutical Industries Ltd. Industrial Area 3, Dewas, 455001,
Madhiya Paradesh India.
API Lot No. AB06444
Description of Pack
Glass vial
Batch No. CI-001 CI-002 CI-003
No. of Batches 03
manufacturer issued by concerned regulatory V/WHOGMP/Rev./Sun-17/2019/5115) issued by
authority of country of origin. Office of the Drugs Controller, Food & Drug
Administration Madhya Pradesh dated 3-10-2019.
The certificate is valid till 02-10-2022.
or analysis” for import of Imipenem / Cilastatin
2Kg from M/s Sun Pharmaceuticals India issued
by AD (I&E) DRAP field office. The license was
issued on 16-01-2020.
Imipenem/cilastatin. The invoice is signed by
AD (I&E) DRAP.
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
data sheets etc.
3
Evaluation by PEC :
297th meeting in XONEM Injection 250mg IV case of M/s Bio-Next Pharmaceuticals Plot No. 50,
St No. S-10, RCCI Industrial Estate Rawat Islamabad.
Decision: Approved.
 M/s Bio-Next Pharmaceuticals shall use 10ml 0.9% NaCl injection as diluent for the
commercial batches and submit compatibility study with the 0.9%NaCl solution as diluent
along with BMR of recently manufactured batches from M/s Bio-Next Pharmaceuticals, as
evidence of use of the recommended diluent before issuance of Registration letter.
 Firm shall submit Pharmaceutical equivalence studies against the innovator product before
issaunce of registration letter.
Pharmaceuticals.
729. Name, address of Applicant / Marketing M/s Cherwel Pharmaceuticals (Pvt) Ltd. Plot #
Authorization Holder 20, Phase 4, Hattar Industrial Estate Hattar.
☐ Importer
2017 is submitted
☐ Export sale
The proposed proprietary name / brand name IMIPEN Injection 500mg IV
Pharmaceutical ingredient (API) per unit Imipenem as monohydrate…500mg
Cilastatin as sodium…500mg
Pharmaceutical form of applied drug Glass vial filled with white t pale yellow powder
along with ampoule of 0.9% NaCl solution.
The status in reference regulatory authorities Impenem and cilastatin Injection (USFDA
Approved)
For generic drugs (me-too status) Cilapen Injection by Bosch Pharma
Name and address of API manufacturer. Sun Pharmaceutical Industries Ltd. Industrial Area
3, Dewas, 455001, Madhiya Paradesh India.
product.
product against the comparator i.e. Cilapen 500mg
Injection (IV) of Bosch Pharmaceuticals.
product analytical method for the drug substance and the
drug product product.
Manufacturer of API Sun Pharmaceutical Industries Ltd. Industrial Area 3, Dewas, 455001,
Madhiya Paradesh India.
API Lot No. AB06444
Description of Pack
Glass vial
Batch No. CI-004 CI-005 CI-006
No. of Batches 03
manufacturer issued by concerned regulatory V/WHOGMP/Rev./Sun-17/2019/5115) issued by
authority of country of origin. Office of the Drugs Controller, Food & Drug
Administration Madhya Pradesh dated 3-10-2019.
The certificate is valid till 02-10-2022.
or analysis” for import of Imipenem / Cilastatin
2Kg from M/s Sun Pharmaceuticals India issued
by AD (I&E) DRAP field office. The license was
issued on 16-01-2020.
Imipenem/cilastatin. The invoice is signed by
AD (I&E) DRAP.
data sheets etc.
3
Evaluation by PEC :
297th meeting in XONEM Injection 500mg IV case of M/s Bio-Next Pharmaceuticals Plot No. 50,
St No. S-10, RCCI Industrial Estate Rawat Islamabad.
Decision: Decision: Approved.
 M/s Bio-Next Pharmaceuticals shall use 10ml 0.9% NaCl injection as diluent for the
commercial batches and submit compatibility study with the 0.9%NaCl solution as diluent
along with BMR of recently manufactured batches from M/s Bio-Next Pharmaceuticals, as
evidence of use of the recommended diluent before issuance of Registration letter.
 Firm shall submit Pharmaceutical equivalence studies against the innovator product before
issaunce of registration letter.
Pharmaceuticals.
b. Deferred cases of local manufacturing
730. Name, address of Applicant / Marketing M/s Martin Dow Marker Limited, 7 Jail Road
Authorization Holder Quetta.
Name, address of Manufacturing site. M/s Martin Dow Limited, Plot No. 37, Sector 19,
Korangi Industrial Area, Karachi-74900, Pakistan
☐ Importer
Contract manufacturing agreement dated 01-02-2021 is
submitted
GMP status of the firm The Firm has submitted copy of GMP certificate based
Evidence of approval of manufacturing Firm has submitted copy of grant of additional section
facility dated 27th October, 2020 specifying Dry Powder Inhaler
Capsule (General)- New.
☐ Export sale
Details of fee submitted PKR 50,000/-: 19-03-2021+
PKR 25,000/-: 15-06-2021
The proposed proprietary name / brand BI HALER DPI Capsule 200mcg / 6mcg
name
Strength / concentration of drug of Active Each Capsule contains:
Pharmaceutical ingredient (API) per unit Budesonide.................................200mcg
Formoterol fumarate dihydrate..............6mcg
Each delivered dose (the dose that leaves the
mouthpiece) contains Budesonide 160 mcg / inhalation
and Formoterol fumarate dihydrate 4.5 mcg / inhalation.
Pharmaceutical form of applied drug Hard gelatin capsule
Pharmacotherapeutic Group of (API) Drugs for obstructive airway diseases:
Adrenergics, Inhalants.
ATC code: R03AK07
Reference to Finished product Innovator’s specifications
specifications
Proposed unit price As per DPC
The status in reference regulatory “SYMBICORT TURBOHALER 200/6mcg
authorities INHALATION POWDER” by AstraZeneca UK
Limited (MHRA approved)
For generic drugs (me-too status) Formiget 200mcg + 6mcg DPI capsule of M/s Getz
Pharma (Reg # 085999)
Name and address of API manufacturer. Budesonide: M/s Aarti Industries Ltd., Unit-IV, Plot
No E – 50, MIDC, Tarapur, Taluka & District Palghar –
401 506, Maharashtra, INDIA
Formoterol fumarate dihydrate: M/s Aarti Industries
Ltd., Unit-IV, Plot No E – 50, MIDC, Tarapur, Taluka
& District Palghar – 401 506, Maharashtra, INDIA.
template. Firm has summarized information related to
nomenclature, structure, general properties, solubilities,
physical form, manufacturers, Characterization,
impurities, specifications, analytical procedures and its
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,
Module-III Drug Substance: Firm has submitted detailed drug substance data related
to nomenclature, structure, general properties,
solubilities, physical form, manufacturers, description
specifications, analytical procedures and its validation,
batch analysis and justification of specification,
Stability Studies of Drug Substance Firm has submitted stability study data of 6 months
(Conditions & duration of Stability studies) accelerated and 60 months real time data of 3 batches of
API.
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
Pharmaceutical Equivalence and Firm has submitted pharmaceutical equivalence of their
Comparative Dissolution Profile formulation with innovator product Symbicort
Turbohaler of M/s Astrazeneca and performed tests of
Aerodynamic particle size distribution (APSD) &
Delivered dose uniformity (DDU) of both capsules.
Analytical method validation/verification Firm has submitted protocols and reports of analytical
of product method validation of drug product.
Manufacturer of API Budesonide: M/s Aarti Industries Ltd., Unit-IV, Plot No E – 50, MIDC,
Tarapur, Taluka & District Palghar – 401 506, Maharashtra, INDIA
Formoterol fumarate dihydrate: M/s Aarti Industries Ltd., Unit-IV, Plot No
E – 50, MIDC, Tarapur, Taluka & District Palghar – 401 506, Maharashtra,
INDIA.
API Lot No. Budesonide: BD-18401
Formoterol fumarate dihydrate: FF-19001
Description of Pack
Alu Alu Blister pack, 30’s
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RH
Frequency Accelerated: 0,3,6 (Months)
Batch No. NPD-C-892-L NPD-C-893-P NPD-C-894-P

Batch Size 6000 capsules 6000 capsules 6000 capsules
Manufacturing Date 02-12-2019 02-12-2019 02-12-2019
No. of Batches 03
1. Reference of previous approval of N/A
applications with stability study data of the
firm (if any)
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of GMP Certificate for M/s
API manufacturer issued by concerned Aarti Industries Ltd., District Palghar – 401 506,
regulatory authority of country of origin. Maharashtra, INDIA issued by Food and Drugs
Administration (Maharashtra State), India. It is valid till
09-06-2023.
3. Documents for the procurement of API with Budesonide: Firm has submitted copy of invoice
approval from DRAP (in case of import). specifying purchase of 40g of Budesonide (micronised)
attested by AD I & E Karachi dated 07-08-2019.
Formoterol Fumarate Dihydrate: Firm has submitted
copy of invoice specifying purchase of 15g of
Formoterol Fumarate Dihydrate (micronised) attested by
AD I & E Karachi dated 19-08-2019
4. Data of stability batches will be supported by Firm has submitted record of testing of batches along
attested respective documents like with chromatograms, raw data sheets, COA and
chromatograms, Raw data sheets, COA, summary data sheets.
summary data sheets etc.
5. Compliance Record of HPLC software The firm has submitted compliance record of HPLC
21CFR & audit trail reports on product software 21 CFR and copies of audit trail on testing of
testing drug product.
6. Record of Digital data logger for temperature Firm has submitted record of data logger for temperature
and humidity monitoring of stability and humidity monitoring of real time and accelerated
chambers (real time and accelerated) stability chambers.
Evaluation by PEC:
Shortcomings communicated Response by the firm

Submit differential fee for the registration of applied Firm has responded that they have already submitted
product, since the notification for revision of fee vide differential fee PKR 25,000/- dated 15-06-2021 vide slip
SRO No. F.7-11/2012-B&A/DRA was published on 7th number 087907483660.
May 2021 while this application was received in R&I
section of DRAP after 7th May 2021.
Submit valid contract manufacturing agreement between Firm has submitted copy of contract manufacturing
the contract giver and contract acceptor. agreement dated 01-02-2021 between the contract giver
and contract acceptor.
Submit product development and stability study data of Firm has submitted 6 months stability study data of trial
commercial batches manufactured by the drug product batches.
manufacturer, since the submitted data are of trial Firm has also submitted stability data sheets for 3 months
batches. stability testing of three commercial batches with
following details:
Batch No: P07381

Batch Mfg Stability API lot
size date initiation date number
13000 07- 11-08-2021 2104000065
packs 2021 2104000146
Batch No: P07388
8659 07- 12-08-2021 2104000065
packs 2021 2104000146
Batch No: P07627

13000 11- 30-11-2021 2104000065
packs 2021 2104000146
However, firm has not submitted complete stability study

data of 3 commercial batches along with requisite
documents as per CTD guidance document.
Decision of 316th meeting of Registration Board:
Deferred for submission of stability study data of three commercial batches in section 3.2.P.8.3 as per the 6-
points checklist provided in Form 5-F guidance document (PE&R/GL/AF/004) approved by the Registration
Board.
Submission by the firm:

Firm has submitted complete stability data of commercial batches for which initial detail was provided in
316th meeting.
297th meeting in TYCORT 200mcg + 6mcg DPI Capsule case of M/s Martin Dow Limited, Plot No.
37, Sector 19, Korangi Industrial Area, Karachi-74900, Pakistan.
 Registration Board in its 321st meeting also decided as “Registration Board deliberated the matter
in detail and decided to also accept product development data / stability data of trial batches
manufactured by contract manufacturer”

The dry powder inhaler capsule is intended to be marketed along with Dry Powder Inhaler Device
of following description:
Name: DPI Device
Model no. BDD07
Capsule size: 3 # Capsule
Manufacturer: Shanghai Huarui Aerosol Co., Ltd,
No.222, Yuanchun Road, Pudong New Area,
Shanghai, china.
Shelf life: 3 years
Decision: Approved. The firm shall submit fee of Rs. 75,000/- for correction/pre-approval change in
stability data as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021, before issuance of
submitted in the registration application
 Registration Board further decided that following details of “Accompanyiing Delivery device”
shall be declared on registration letter:
“Name: DPI Device
Model no. BDD07
Shanghai, china.
Shelf life: 3 years”
upon satisfactory capacity assessment of manufacturing and testing facility of M/s Martin
Dow Limited, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi-74900, Pakistan
☐ Importer
submitted
☐ Export sale
Details of fee submitted PKR 50,000/-: 19-03-2021+
PKR 25,000/-: 15-06-2021
The proposed proprietary name / brand BI HALER DPI Capsule 400mcg / 12mcg
name
Pharmaceutical ingredient (API) per unit Budesonide.................................400mcg
Formoterol fumarate dihydrate..............12mcg
Pharmacotherapeutic Group of (API) Drugs for obstructive airway diseases:
Adrenergics, Inhalants.
ATC code: R03AK07
specifications
The status in reference regulatory “SYMBICORT TUBOHALER 400/12mcg
authorities INHALATION POWDER” by AstraZeneca UK
Limited (MHRA approved)
For generic drugs (me-too status) Formiget 400mcg + 12mcg DPI capsule of M/s Getz
Pharma (Reg # 098723)
Name and address of API manufacturer. Budesonide: M/s Aarti Industries Ltd., Unit-IV, Plot
No E – 50, MIDC, Tarapur, Taluka & District Palghar –
401 506, Maharashtra, INDIA
Formoterol fumarate dihydrate: M/s Aarti Industries
Ltd., Unit-IV, Plot No E – 50, MIDC, Tarapur, Taluka
& District Palghar – 401 506, Maharashtra, INDIA.
API.
Comparative Dissolution Profile formulation with innovator product Symbicort
Turbohaler of M/s Astrazeneca and performed tests of
Aerodynamic particle size distribution (APSD) &
Delivered dose uniformity (DDU) of both capsules.
Manufacturer of API Budesonide: M/s Aarti Industries Ltd., Unit-IV, Plot No E – 50, MIDC,
Tarapur, Taluka & District Palghar – 401 506, Maharashtra, INDIA
Formoterol fumarate dihydrate: M/s Aarti Industries Ltd., Unit-IV, Plot No
E – 50, MIDC, Tarapur, Taluka & District Palghar – 401 506, Maharashtra,
INDIA.
API Lot No. Budesonide: BD-18401
Formoterol fumarate dihydrate: FF-19001
Description of Pack
Frequency Accelerated: 0,3,6 (Months)
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Aarti Industries Ltd., District Palghar – 401 506,
regulatory authority of country of origin. Maharashtra, INDIA issued by Food and Drugs
Administration (Maharashtra State), India. It is valid till
09-06-2023.
3. Documents for the procurement of API with Budesonide: Firm has submitted copy of invoice
approval from DRAP (in case of import). specifying purchase of 40g of Budesonide (micronised)
attested by AD I & E Karachi dated 07-08-2019.
Formoterol Fumarate Dihydrate: Firm has submitted
copy of invoice specifying purchase of 15g of
Formoterol Fumarate Dihydrate (micronised) attested by
AD I & E Karachi dated 19-08-2019
4. Data of stability batches will be supported by Firm has submitted record of testing of batches along
Evaluation by PEC:

following details:
Batch No: P07404

10333 08- 16-08-2021 2104000065
packs 2021 2104000146
Batch No: P07408
13000 08- 23-08-2021 2104000065
packs 2021 2104000146
Batch No: P07438

13000 08- 03-09-2021 2104000065
packs 2021 2104000146

Board.

316th meeting.
297th meeting in TYCORT 400mcg + 12mcg DPI Capsule case of M/s Martin Dow Limited, Plot
No. 37, Sector 19, Korangi Industrial Area, Karachi-74900, Pakistan.
Registration Board in its 321st meeting also decided as “Registration Board deliberated the matter in detail
and decided to also accept product development data / stability data of trial batches manufactured by
contract manufacturer”
“Name: DPI Device
Model no. BDD07
Shanghai, china.
 Shelf life: 3 years”.
satisfactory capacity assessment of manufacturing and testing facility of M/s Martin Dow
Limited, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi-74900, Pakistan
☐ Importer
submitted
☐ Export sale
PKR 25,000/-: 15-06-2021
The proposed proprietary name / brand TIO HALER DPI Capsule 18 mcg
name
Pharmaceutical ingredient (API) per unit 22.5mcg of Tiotropium bromide monohydrate eq. to
Tiotropium…………..18mcg
The delivered dose (the dose that leaves the mouthpiece)
is 10.4 mcg Tiotropium.
Pharmacotherapeutic Group of (API) Anticholinergic agents
specifications
The status in reference regulatory Spiriva 18 mcg capsule (USFDA approved)
authorities
For generic drugs (me-too status) Gentrop 18 mcg Rotacaps of Genix Pharma
(Reg#086941)
Name and address of API manufacturer. M/s Vamsi Labs Ltd.
Address A-14/15, MIDC area, Chincholi, Solapur-
413255, Maharashtra, India
API.
Comparative Dissolution Profile formulation with innovator product Spiriva 18mcg DPI
Capsule of M/s Boehringer Ingelheim and performed
tests of Aerodynamic particle size distribution (APSD)
& Delivered dose uniformity (DDU) of both capsules.
Manufacturer of API M/s Vamsi Labs Ltd.,

Address A-14/15, MIDC area, Chincholi, Solapur-413255, Maharashtra, India
API Lot No. TBM0090619
Description of Pack
No. of Batches 03
firm (if any)
API manufacturer issued by concerned Vamsi Labs Ltd., India issued by Food and Drugs
regulatory authority of country of origin. Administration (Maharashtra State), India. It is valid till
19-05-2020.
3. Documents for the procurement of API with Firm has submitted copy of invoice specifying purchase
approval from DRAP (in case of import). of 20g of Tiotropium Bromide Monohydrate
(micronised) attested by AD I & E Karachi dated 02-11-
2021.
4. Data of stability batches will be supported by Firm has submitted record of testing of all batches along
Evaluation by PEC:

following details:
Batch No: P07380

12333 07- 04-08-2021 2103000010
packs 2021
Batch No: P07387

9333 08- 27-08-2021 2103000010
packs 2021
Batch No: P07456

12466 09- 16-09-2021 2103000010
packs 2021

Board.
316th meeting.
297th meeting in Tiohale DPI Capsule 18 mcg case of M/s Martin Dow Limited, Plot No. 37, Sector
19, Korangi Industrial Area, Karachi-74900, Pakistan.
Registration Board in its 321st meeting also decided as “Registration Board deliberated the matter in detail
and decided to also accept product development data / stability data of trial batches manufactured by
contract manufacturer”
“Name: DPI Device
Model no. BDD07
Shanghai, china.
 Shelf life: 3 years”.
satisfactory capacity assessment of manufacturing and testing facility of M/s Martin Dow
Limited, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi-74900, Pakistan
733. Name, address of Applicant / M/s Swiss Pharmaceuticals Pvt Ltd A/159,
Marketing Authorization Holder SITE-II Super Highway Karachi.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No.
Islamabad.
☐ Importer
☒ Is involved in none of the above (contract
giver)
GMP status of the firm Firm has submitted copy of GMP certificate of
M/s Vision Pharmaceuticals dated 25-03-2022
based on inspection dated 11-02-2019. As per
the certificate, it was valid till 09-05-2022.
Evidence of approval of manufacturing Firm has submitted copy of letter of renewal of
facility DML of M/s Vision Pharmaceuticals DML No
000517 dated 07-06-2021 specifying sterile dry
powder injectable vial (General) section.
☐ Export sale
The proposed proprietary name / brand PTONIX 40mg IV Injection
name
Strength / concentration of drug of Each vial Contains:
Active Pharmaceutical ingredient (API) Pantoprazole (as sodium)………40mg
per unit
Pharmaceutical form of applied drug White or almost white colored lyophilized
powder
Pharmacotherapeutic Group of (API) PPI
Reference to Finished product BP specification
specifications
The status in reference regulatory Protonix IV 40mg (USFDA Approved)
authorities
For generic drugs (me-too status) Zopent Injection by Hilton
Name and address of API manufacturer. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No.
Islamabad.
product.
substance data related to nomenclature,
structure, general properties, solubilities,
physical form, manufacturers, description of
manufacturing process and controls, impurities,
specification, reference standard, container
closure system and stability studies of drug
substance.
(Conditions & duration of Stability batches of drug substance at both accelerated as
studies) well as real time conditions. The accelerated
stability data is conducted at 40°C ± 2°C / 75%
± 5% RH for 6 months. The real time stability
data is conducted at 30°C ± 2°C / 65 ± 5% RH
for 36 months.
Module-III Drug Product: Firm has submitted data of drug product
including its description, composition,
process validation protocols, control of
excipients, control of drug product,
specifications, analytical procedures, validation
of analytical procedures, batch analysis,
stability.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical
Comparative Dissolution Profile equivalence for their product against Protonix IV
Injection of Pfizer Pharmaceutical
Analytical method validation/verification Firm has submitted verification studies of the
of product drug substance and the drug product.
Manufacturer of API M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-23, Industrial
Triangle Kahuta Road Islamabad.
API Lot No. 2008902
Description of Pack
Glass vial
Stability Storage Real time: 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Batch No. 2009714 2009715 2009716
Batch Size 16,800 Vials 16,800 Vials 16,800 Vials
No. of Batches 03
1. Reference of previous approval of Not submitted
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate dated
API manufacturer issued by concerned 31-07-2019 of M/s Vision Pharmaceuticals
regulatory authority of country of origin. (DML No. 000806 semi basic) issued based on
3. Documents for the procurement of API with Firm has submitted inventory transfer note from
approval from DRAP (in case of import). SAP of the firm dated 08-10-2020 for the same
batch.
4. Data of stability batches will be supported Firm has submitted complete record of testing of
by attested respective documents like all batches along with raw data sheets, COA and
summary data sheets.
chromatograms, Raw data sheets, COA,
5. Compliance Record of HPLC software Not submitted
21CFR & audit trail reports on product
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger
temperature and humidity monitoring of for temperature and humidity monitoring of real
stability chambers (real time and time and accelerated stability chambers.
accelerated)
Evaluation by PEC:
The application of the firm for contract manufacturing from M/s Vision Pharmaceuticals (Pvt) Ltd.
Plot No. 22-23, Industrial Triangle Kahuta Road Islamabad was not submitted as per the guidance
document approved by Registration Board. The submitted application was in variation to the
guidance document for various modules, sections and sub sections majorly including complete
module 1, section 3.2.S.4.1, 3.2.S.4.2, 3.2.S.4.3, 3.2.S.4.4, 3.2.S.5, 3.2.P.2.2.1, 3.2.P.2.6, 3.2.P.3.5,
3.2.P.5.1, 3.2.P.5.2, 3.2.P.5.3, 3.2.P.5.4, 3.2.P.6 and 3.2.P.8. Furthermore, it is also pertinent to
mention that the drug product manufacturer has submitted COA of drug substance which is released
on 26-02-2018 and provided batch release certificates of 3 batches of drug product released on 09-
2017 instead of submitting data of same batches as per the guidance document. Therefore, the firm
was advised to resubmit the application compiled in the light of the guidance document approved
by Registration Board so that further evaluation of your application could be carried out.
In response, the firm has changed drug product specifications from in house to BP without
submission of fee. Firm has also changed the drug substanbce source from Everest Organics Limited
Aroor Village Sadasivapet Mandal Sangareddy District Aroor (V), Sadasivpet(M), Sangareddy
District Telangana India to M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-23, Industrial
The response was also evaluated, and the found deficient for various points. The following points
were communicated to the firm.
Sr. Shortcomings communicated Response by the firm

No
1. Submit label claim of the applied Firm has submitted following label claim
product in line with innovator product without submission of fee.
/ reference product along with Each vial Contains:
submission of requisite fee. Pantoprazole (as sodium)………40mg
2. In your initial submission, you have In our previous submission the testing for 3
mentioned in house specifications for batches was done on UV, but parallel we change
the drug product, while in the later our Standard Analytical Procedure and shift our
submission you have mentioned BP testing method to HPLC.
specifications. Justification is Firm has submitted Revised testing method
required in this regard along with which was signed and issued on 31-12-2021.
evidence when you have changed the This method contains HPLC test for assay of
specifications of your already drug product, however, for bulk stage the assay
registered product. method was based on UV.
As per Documents, firm has changed assay to
HPLC method on 31-12-2021 while the stability
data was initiated on October 2020.
Furthermore, firm could not provide any
evidence of intimation to DRAP regarding
revision of the specifications of their already
registered product from in house to BP specs.
3. In your initial application you have As we have two DMLs one for finished drugs
specified that the source of drug and secod for semi basic dosage forms. The
substance is Everest Organics Limited lyophilized pantoprazole is always procured
Aroor Village Sadasivapet Mandal from M/s Vision Pharmaceuticals but the
Sangareddy District Aroor (V), powder pantoprazole for lyophilization is
Sadasivpet(M), Sangareddy District procured from Everest organics limited.
Telangana India, while in new
submission you have changed the
source to M/s Vision Pharmaceuticals
(Pvt) Ltd. Plot No. 22-23, Industrial
Justification is required in this regard
along with submission of requisite
fee.
4. Submit data in section 3.2.S.4.1 and Firm has submitted standard testing method of
3.2.S.4.2 as per the guidance pantoprazole sodium sesquihydrate drug
document approved by Registration substance from Vision Pharmaceuticals dated
Board which specifies that “Copies of 29-12-2021. The submitted document does not
the Drug substance specifications and specify whether it is of semi basic DML or of
analytical procedures used for routine DML issued by way of formulation. Moreover
testing of the Drug substance /Active the specifications are issued on December 2021
Pharmaceutical Ingredient by both while stability batches were manufactured in
Drug substance & Drug Product October 2020.
5. Submit data in section 3.2.S.4.3 as per Firm has submitted verification studies dated
the decision of 293rd meeting of 05-09-2020 based on HPLC method, while as
Registration Board, which states that per the submitted specifications of the drug
“Analytical Method Verification substance, the assay method is based on
studies including specificity, accuracy potentiometric titration.
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 COA of drug substance Firm submitted that it was a typo error.
manufacturer specifies that the Firm has submitted another copy of COA of the
material was released on 31-09-2020 same batch.
while the drug product manufacturer In the newly submitted COA from Vision
has sampled the product on 02-09- Pharmaceuticals (Semi-Basic DML) the batch
2020 and released on 16-09-2020. was released on 31-08-2020 as per In-house
Justification is required in this regard. specification and assay on UV method. While as
per the raw material analysis report from Vision
Pharmaceuticals (Formulation DML), the batch
was released on 16-09-2020 as per Innovator’s
specification and assay on UV method.
The drug substance specifications, BP
monograph and submitted COA are
contradictory.
7. Justify the use of 10ml water for Firm has submitted that they are using 10ml of
injection as diluent since the 0.9% sodium chloride solution as diluent.
innovator product recommends that However previously the firm has specified water
the product should be reconstituted for injection as the diluent.
with 10ml 0.9% sodium chloride
solution.
8. Submit results of compatibility Firm has not submitted compatabiity study
studies in section 3.2.P.2.6. report instead only submitted a batch release
report.
9. The analytical method and The provided analytical method and
specifications of the drug product has specifications of drug product has been
been generated and signed on 31-12- submitted is the updated one, replacing the old
2021 with a dsscription “this is a new version.
document on this subject” while the As per Documents, firm has changed assay to
stability batches were manufactured HPLC method on 31-12-2021 while the stability
in September 2020. Justify how the data was initiated on October 2020.
submitted specifications could be Furthermore, firm could not provide any
considered applicable for testing of evidence of intimation to DRAP regarding
these batches. revision of the specifications of their already
registered product from in house to BP specs.
10. Analytical method alidation studies of Firm has once again submitted same old
the drug product were developed in verification studies of 2017 in which the assay
2017 wherein the specifications and method was different from that specified in the
analytical method of BP 2020 were latest specifications of the firm as well as BP
claimed. Justify how validation of monograph.
analytical method of 2020 can be
performed in 2017.
11. Justify how three batches of drug It was a typo error, updated range was according
product with BP specs were released to BP.
on 05-10-2020 while the drug
specifications are different from that
specified in BP monograph and are
exactly same as that submitted in
initial application as in-house
specifications.
12. Submit evidence of procurement of Firm has submitted inventory transfer note from
the drug substance. SAP of the firm dated 08-10-2020 for the same
batch.
However, the document does not specify any
quantity. Moreover, the document for transfer of
inventory is of 08-10-2020, while as per the raw
material analysis report from Vision
Pharmaceuticals (Formulation DML), the batch
was released on 16-09-2020.
13. Justify how the manufacturing of The drug substance was released on 07-09-2020.
commercial batches were carried out However as per invoice the material was
from 17-09-2020 while the drug transferred on 08-10-2020, and as per raw
substance used in those batches was material analysis report the material was
released on 31-09-2020. released on 16-09-2020.
Deferred for following:
 Submission of applicable fee for revision of source of drug substance, revision of
specifications and label claim as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-
2021.
 Scientific justification how a revised HPLC method dated 31-12-2021 can represent the
results of the stability studies which were initiated in October 2020.
 Approval of DRAP for change in specifications of the registered product for which stability
data is submitted.
 Scientific justification for performing verification studies of analytical method of drug
substance dated 05-09-2020 based on HPLC method, while as per the submitted
specifications of the drug substance, the assay method is based on potentiometric titration.
 Scientific justification for having drug substance specifications which are different from the
specifications of drug substance manufacturer as well as BP monograph.
 Clarification about the use of 10ml water for injection as diluent for the applied product
since the innovator product recommends different diluent.
 Verification studies of the analytical method of drug product.
 Evidence of procurement of the drug substance.
 Scientific justification for manufacturing and testing commercial batches of a registered
drug product on non-pharmacopoeial specifications while BP monograph was already
available for the drug product.
Sr. No Reason for deferment Response by the firm
1. Submission of applicable fee for revision Firm has not submitted any fee.
of source of drug substance, revision of
specifications and label claim as per
notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
2. Scientific justification how a revised Change specification granted from DRAP
HPLC method dated 31-12-2021 can in May 2021, after that testing
represent the results of the stability studies specification change to BP from vision
which were initiated in October 2020. specification. Testing method also revised
after grant of this permission from DRAP.
3. Approval of DRAP for change in Firm has submitted one page which shows
specifications of the registered product for that specifications of Fitral 40mg
which stability data is submitted. Injection is changed from inhouse to BP
Specs. However, the letter do not contain
first page which shows date of the
4. Scientific justification for performing Raw material once received is
verification studies of analytical method of Lyophilized by Vision Semi Basic Plant
drug substance dated 05-09-2020 based on and that Lyophilized ready to fill powder
HPLC method, while as per the submitted is then filled in vials.
specifications of the drug substance, the So, Method verification/validation of that
assay method is based on potentiometric Lyophilized material is performed by
titration. HPLC which is according to BP method,
and that material is filled in Vials.
The titration method is just mentioned for
Pantoprazole sodium sesquihydrate Raw
material, not for Lyophilized material.
5. Scientific justification for having drug Pantoprazole sodium (Lyophilized) is
substance specifications which are present in BP Monograph and we are
different from the specifications of drug following BP Specs.
substance manufacturer as well as BP
monograph.
6. Clarification about the use of 10ml water Normal saline 10ml under registration
for injection as diluent for the applied with DRAP, water for injection only use
product since the innovator product to solubilized the material and this 10ml
recommends different diluent. solution transfer to 100ml Normal saline
infusion.
7. Verification studies of the analytical Verification studies of drug product are
method of drug product. provided by the firm.
8. Evidence of procurement of the drug Firm has submitted inventory transfer
substance. note from SAP of the firm dated 06-07-
2020 for batch008902.
9. Scientific justification for manufacturing Change specification granted from DRAP
and testing commercial batches of a in May 2021, after that testing
registered drug product on non- specification change to BP from vision
pharmacopoeial specifications while BP specification. Testing method also revised
monograph was already available for the after grant of this permission from DRAP
drug product.
 Review of manufacturing requirement of the applied product as per innovator drug
product or reference regulatory authority, whether lyophilized or otherwise.
 details of already registered drug products with available manufacturing facilities
734. Name, address of Applicant / M/s Swiss Pharmaceuticals (Pvt) Ltd. A/159, SITE, Super
Marketing Authorization Holder Highway Karachi.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot No. 204-205,
Industrial Triangle Kahuta Road Islamabad.
☐ Importer
pharmaceutical products between contract giver and
acceptor dated 29-05-2020 is submitted.
GMP status of the firm Swiss Pharmaceuticals: 18-10-2018: GMP compliance
level is rated as GOOD.”
Global pharmaceuticals: 11 & 24-10-2018: On the basis
of findings, panel unanimously decided to recommend the
issuance of GMP certificate.
Evidence of approval of Firm has submitted copy of letter of Grant of additional
manufacturing facility section / amendment under DML No 000417 of M/s Global
Pharmaceuticals Islamabad dated 18-12-2017 specifying
reallocation of dry powder injection (carbapenem) section in
place of withdrawn Biotech section (BSF)
Intended use of pharmaceutical ☒ Domestic sale
product ☐ Export sale
Proposed proprietary name / brand CILSNIM 500mg Injection IV
name
Strength/ concentration of drug of Each vial contains:
Active Pharmaceutical ingredient Imipenem (as monohydrate).……500mg
(API) per unit Cilastatin (as sodium)……………500mg
Pharmaceutical form of applied drug White to pale yellow powder filled in clear glass vials with
grey rubber stopper and blue color flip off seal
Reference to Finished product USP
specifications
Status in reference regulatory Primaxin Injection (USFDA Approved)
authorities
For generic drugs (me-too status) Onem Injection of Global Pharmaceuticals
Name and address of API Zhuhai United Laboratories Co., Ltd. No. 2428, Anji Road,
manufacturer. Sanzao Town, Jinwan District, Zhuhai City Guangdong
Province China
Firm has summarized information related to nomenclature,
structure, general properties, solubilities, physical form,
and its validation, batch analysis and justification of
and stability studies of drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance data
related to nomenclature, structure, general properties,
solubilities, physical form, manufacturers, description of
drug substance.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of drug
(Conditions & duration of Stability substance at both accelerated as well as real time conditions.
studies) The accelerated stability data is conducted at 25°C ± 2°C /
60% ± 5% RH for 6 months. The real time stability data is
conducted at 5°C ± 3°C for 36 months.
manufacture, manufacturing process and process control,
process validation protocols, control of excipients, control
of drug product, specifications, analytical procedures,
justification of specifications, reference standard or
materials, container closure system and stability.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical equivalence
Comparative Dissolution Profile for the quality tests for their product against Primaxin
Injection IV of Merck & Co.
Analytical method Firm has submitted verification studies of the drug
validation/verification of product substance and the drug product.
Manufacturer of API Zhuhai United Laboratories Co., Ltd. No. 2428, Anji Road, Sanzao Town,
Jinwan District, Zhuhai City Guangdong Province China
API Lot No. 3951902009
3951903005
Description of Pack
Glass vial
Time Period Real time: 6 months Accelerated: 6 months
Frequency Accelerated: 0, 3, 6 (Months) Real Time: 0, 3, 6 (Months)
Batch No. 19G096 19G097 19G098
No. of Batches 03
1. Reference of previous approval of The firm has referred to previous inspection of stability data
applications with stability study data of of the same dosage form on the basis of which Registration
the firm (if any) Board in 289th meeting decided to approve registration of
Promig Plus 500mg/20mg Tablet and Promig Plus
375mg/20mg Tablet.
Inspection date: 14th March, 2019
chambers.
2. Approval of API/ DML/GMP certificate Firm has submitted copy of GMP certificate (No.
of API manufacturer issued by concerned GD20180909) issued by China Food and Drugs
regulatory authority of country of origin. Administration. The certificate is valid till 12-05-2023.
3. Documents for the procurement of API 3951902009: Firm has submitted copy of commercial
with approval from DRAP (in case of invoice cleared dated 27-06-2019 specifying import of 50Kg
import). imipenem and cilastatin for injection. The commercial
invoice is attested by AD (I&E) DRAP field office.
3951903005:
No evidence of import is submitted for this batch.
4. Data of stability batches will be supported Firm has submitted complete record of testing of all batches
by attested respective documents like along with chromatograms, raw data sheets, COA and
5. Compliance Record of HPLC software Not submitted.
testing
6. Record of Digital data logger for Firm has submitted record of digital data logger for
temperature and humidity monitoring of temperature and humidity monitoring of real time and
stability chambers (real time and accelerated stability chambers.
accelerated)
Evaluation by PEC:
Provide correct label claim as per the innovator / Firm has revised the label claim as per the reference product
reference product in section 1.5.2 along with without submission of fee.
submission of requisite fee, since the submitted label
claim is not as per reference product.
Justify your drug substance without sodium Firm has submitted that the drug substance contains sodium
bicarbonate since USP as well as reference product bicarbonate. Firm has also submitted COA of drug substance
specifies that sodium bicarbonate is present in the which specify sodium bicarbonate.
finished drug product.
Provide data in section 3.2.S.4.3 as per the guidance Firm has submitted that we have performed method
document approved by Registration Board which verification for drug product and we are using the same
specifies that “Analytical Method Verification testing method for the drug substance therefore we did not
studies including specificity, accuracy and perform verification studies of the drug substance.
repeatability (method precision) performed by the
Drug Product manufacturer for both compendial as
well as non-compendial drug substance(s) shall be
submitted”. Further justify how the analysis of drug
substance was carried out without performing
verification studies.
Submit CoA of reference standard used in the testing Firm has submitted USP certificate of reference standard for
of drug substance in section 3.2.S.5. imipenem as well as cilastatin.However the method of
analysis submitted by the firm specify that they are not using
this reference standard.
Justify how 1106mg drug substance is equivalent to Firm has not submitted any justification against this
500mg of imipenem and 500mg cilastatin along with observation
sodium bicarbonate.
Justify the use of 10ml WFI as a diluent along with Firm has submitted that WFI is used for reconstitution of
applied product. Since this diluent is not used by the those injectables vials which is injected through IV.
innovator / reference product. Innovator mentioned on label of the vials that after
suspension, vial contents transferred to 100ml of infusion
solution and does not describe the procedure for preparation
of the suspension of the vial contents. So based on this fact
use of WFI is suitable and justified.
Innovator product does not recommend reconstitution with
WFI
Justify why the pharmaceutical equivalence study As per WHO guidelines pharmaceutical equivalence for
does not include all critical steps as mentioned in parenteral drugs is not required but we applied two test for
USP monograph. quality and safety of our product that are pH and assay.
Firm has not submitted any evidence of such guidelines. Nor
they have submitted any scientific justification for skipping
important tests.
Provide data in section 3.2.P.2.6 as per the guidance Firm has submitted that Innovator mentioned on label of the
document approved by Registration Board which vials that after suspension, vial contents transferred to 100ml
specifies that “Compatibility studies for the dry of infusion solution and does not describe the procedure for
powder for injections and dry powder for suspension preparation of the suspension of the vial contents and
shall be performed as per the instructions provided in particular diluent. WFI is used for reconstitution of those
individual label of the drug product.” injectables vials which is injected through IV so based on
this fact we used WFI as diluent.
Firm has not submitted compatibility studies as per the
requirement of CTD.
Justify why the test of “constituted solution” and Firm has submitted that testing method has been revised as
“particulate matter in injection” is not included in per USP.
your product specification since these tests are Firm has not submitted any fee for revision of specification
recommended by USP. and testing method. Moreover the submitted testing method
is different from USP monograph in terms of standard
preparation, and assay calculation method and formula.
Justify the test of pH in section 3.2.P.5.2 which Firm has submitted that Innovator mentioned on label of the
specifies that reconstitute the sample in 10ml WFI, vials that after suspension, vial contents transferred to 100ml
however USP specifies that reconstitute as directed of infusion solution and does not describe the procedure for
in the labelling. The labelling of the innovator / preparation of the suspension of the vial contents and
reference product does not recommend reconstitution particular diluent. WFI is used for reconstitution of those
in WFI. injectables vials which is injected through IV so based on
this fact we used WFI as diluent.
Firm has not submitted any justification for the observation.
Justify the use of imipenem + cilastatin working Firm has again submitted separate USP certificate of
standard for the assay since USP has recommended reference standard for imipenem as well as cilastatin.
separate standard preparation for imipenem as well However the method of analysis submitted by the firm
as cilastatin for the assay test. specify that they are not using seprate reference standard.
Justify why the calculation formula used for the assay Firm has submitted that testing method is revised and all
test is different from that specified in USP required formulas incorporated.
monograph. However as per the revised testing method the formula is
different from that specified in USP monograph.
Clarify the batch size of stability batches, since batch Typographic error.
size of 9041 vials is mentioned in stability data The batch size is 9041 vials.
sheets, while 4520 vials is mentioned in product
batch analysis certificate.
USP recommends separate injections of imipenem Firm has submitted that seprate imipenem and cilastatin
and cilastatin standard preparation, while you have sodium commercial material is not available with us. We
used same standard preparation containing both drug standardized our combined available material with USP
substances. Justification is required in this regard. reference standard of imipenem and cilatstatin and using it
as secondary working standard for routine testing of drug
substance and product.
Firm has not submitted any scientific justification.
Reference of previous approval of applications with Not submitted
stability study data of the firm (if any)
Documents for the procurement of API (Batch Not submitted
number 3951903005) with approval from DRAP.
Compliance Record of HPLC software 21CFR & Not submitted
Decision of 312nd meeting of Registration Board:
Registration Board delibrated the case in detail and observed that the contract manufacturer has not
performed complete product development studies, the specifications adopted by the manufacturer throughout
stability studies were not according to USP and that the stability batches have also expired.
 Scientific justification for not performing verification studies for analytical method of drug
substance.
 Certificate of analysis of reference standard which is actually used in the analysis of drug substance
and drug product.
 Scientific justification for using pre-mixed drug substance having both imipenem as well as cilatatin
as working standard for analysis of commercial bathes of drug product.
 Scientific justification for having a master formulation containing 1106mg of drug substance in pre-
mixed form containing imipenem monohydrate, cilastatin sodium as well as sodium bicarbonate
which is equivalent to 500mg imipenem and 500mg cilastatin.
 Scientific justification for using water for injection as a diluent for your commercial batches contrary
to the diluent recommended by the innovator / reference product.
 Scientific justification for not performing complete pharmaceutical equivalence studies as per the
USP specifications against the innovator product.
 Scientific justification for not performing compatability studies of your product with the
recommended diluent.
 Scientific justification for not performing test of “constituted solution” and “particulate matter in
injection” in your commercial batches since these tests have been recommended in USP monograph.
 Scientific justification for your test of pH which specifies that “reconstitute the sample in 10ml
WFI”, however USP specifies that reconstitute as directed in the labelling and the labelling of the
innovator / reference product does not recommend reconstitution in WFI.
 Scientific justification for having the method of sample solution preparation for the commercial
batches which is entirely different from that specified in USP monograph.
 Scientific justification for using an entirely different formula for calculation of assay resultsof
commercial batches from that specified in USP monograph.
 Scientific justification for using standard preparation containing both drug substances i.e. imipenem
and cilastatin in a single injection for testing your commercial batches while USP recommends
separate injections of imipenem and cilastatin standard preparation.
 Documents confirming import of drug substance having drug substance batch number 3951903005.
 Submission of fee for pre-registration changes in the drug product specifcations.
Keeping in view the above, the Board decided that the submitted stability study data is not acceptable and
directed the manufacturer to either perform complete product development and stability studies or submit
the aforementioned data as per USP specifications and submit data accordingly. The Board further directed
the manufacturer to comply USP Specifications for already registered drug products.
Response by the firm:
Shortcoming Reply
Scientific justification for not performing verification Method verification for the drug product (Imipenem
studies for analytical method of drug substance. and Cilastatin for Injection) is performed and same
testing method is being used for the drug substance
(because it is ready to fill powder). As method is same
therefore this method verification is applicable for
both.
Method verification of Imipenem and Cilastatin for
Injection is also provided. The verification studies
were performed on the analytical method in which
standard preparation and sample preparation is not
exactly as per USP monograph.
Certificate of analysis of reference standard which is In house working standard analytical report as
actually used in the analysis of drug substance and drug Standardization report of API with reference standard
product. is provided by the firm.
Firm has used the premixed drug substance as
working standard which is not recommended by USP.
Scientific justification for using pre-mixed drug We used premix of drug substance (Imipenem &
substance having both Imipenem as well as Cilastatin Cilastatin for Injection) as working standard (batch
as working standard for analysis of commercial batches no. 2009R0099) after standardizing it against
of drug product. Imipenem USP reference standard (lot no. R038R0)
& Cilastatin USP reference standard (lot no.
R012Y0).
Scientific justification for having a master formulation Below is the calculation of fill weight if Imipenem &
containing 1106mg of drug substance in pre-mixed Cilastatin for Injection:
form containing Imipenem monohydrate, Cilastatin For assay of API, attached certificate of analysis specifies
sodium as well as sodium bicarbonate which is NLT 400µg/mg of Imipenem and 400µg/mg of Cilastatin,
equivalent to 500 mg Imipenem and 500mg Cilastatin. while ratio of Imipenem to Cilastatin is 0.95 ~ 1.05 : 1.
Therefore, in order to adjust claim of drug substance we
have to choose component with lower potency.
In this case Imipenem has low potency i.e. 452 µg/mg.
Now, 452µg/mg x 100 = 45.2%
1000
After considering both Imipenem & Cilastatin at 45.2
For Onem 500mg = 100 x 500 = 1106.19mg/vial
45.2%
Scientific justification for using water for injection as Water for Injection will not be part of Cilsnim
a diluent for your commercial batches contrary to the Injection; we have revised our artwork in order to
diluent recommended by the innovator / reference eliminate the water for injection.
product. The revised artwork specifies that after reconstitution
administer the solution within 12 hours while the
innovator product recommends that the product
should be administered within 4 hours after
reconstitution.
Scientific justification for not performing complete All tests that are mentioned in USP could not perform
pharmaceutical equivalence studies as per the USP during pharmaceutical equivalence due to limited
specification against the innovator product. quantity of innovator sample. Therefore, we have
included only all major test while performing
pharmaceutical equivalence.
Scientific justification for not performing compatibility Compatibility studies were performed but were not
studies of your product with the recommended diluent. made of CTD application. Copy of compatibility
studies is provided by the firm.
Scientific justification for not performing test of As for as test of particulate matter is concerned, we
“constituted solution” and “particulate matter in have purchase Liquid particle counter in March 2020,
injection” in your commercial batches since these test that why this test was not performed during
have been recommended in USP monograph. manufacturing of stability batches. Currently we use
Liquid particle counter to perform this test. Firm has
submitted following documents
• Service report of IQ, OQ and PQ of Liquid
Particle counter is enclosed for your review.
• Report including test of particulate matter is
attached.
• Revised test method is also attached.
Scientific justification for your test for pH which As per USP monograph pH of Imipenem and
specifies that “reconstitutes the sample in 10ml WFI”, Cilastatin for Injection should be “between 6.5 and
however USP specifies that reconstitute as directed in 8.5, when constituted as directed in the labeling”.
the labeling and the labeling of the innovator /
reference product does not recommend reconstitution Based upon above statement, we reconstitute content
in WFI. of vial using sterile water for injection, then make the
volume up to 100ml using normal saline (saline TS)
and then check pH of solution using calibrated pH
meter.
Scientific justification for having the method of sample Sample solution preparation mentioned in our testing
solution preparation for the commercial batches which method is same as in USP.
is entirely different from that specified in USP Copy of revised test method and USP monograph is
monograph. also provided.
The testing method which was submitted along with
the original application was not as per USP
monograph.
Scientific justification for using an entirely different Formula of content of drug product is elaborated with
formula for calculation of assay results of commercial context to standard and sample preparation procedure
batches from that specified in USP monograph. which has now been updated as per USP format.
Documents provided are;
• Copy of revised test method and USP monograph
is attached.
Scientific justification for using standard preparation We used premix of drug substance (Imipenem &
containing both drug substance i.e. Imipenem and Cilastatin for Injection) as working standard while
Cilastatin in a single injection for testing your testing of our standard solution as working standard
commercial batches while USP recommends separate was made after standardizing it against separate
injection of Imipenem and Cilastatin standard
Imipenem USP reference standard & Cilastatin USP
preparation
reference standard.
Moreover, for future we have planned to
import/purchase separate Imipenem and Cilastatin
and standardize against USP reference standards.
Documents confirming import of drug substance Firm has submitted copy of commercial invoice but
having drug substance batches number 3951903005. for batch number 3951805003.
Submission of fee for pre-registration changes in the Firm has submitted fee 7500/- dated 05-11-2021 for
drug product specifcations. change in specifications
Keeping in view the above, the Board decided that the Firm has not submitted product development and
submitted stability study data is not acceptable and stability study data of new batches in which the
directed the manufacturer to either perform complete development and testing is carried out as per USP
product development and stability studies or submit the specifications from initial time point.
aforementioned data as per USP specifications and
submit data accordingly. The Board further directed
the manufacturer to comply USP Specifications for
already registered drug products.
Registration Board deliberated that the commercial batches manufactured by the manufacturer i.e. Global
Pharmaceuticals was not developed and tested as per the USP monograph. Keeping in view the USP
monograph, public assessment report of the innovator product and the data submitted by the firm, the Board
decided to defer the case and advised the manufacturer to perform product development studies keeping in
view the innovator product and product testing and stability studies by complying USP monograph and
submit data upon completion of 6 months stability studies.
Firm has submitted completely new CTD for the same product manufactured by M/s Global Pharmaceuticals.
The response of the firm along with product development and stability data was received in R&I DRAP vide
Dy number 28764 dated 11-10-2022. The evaluation of newly submitted data is as under:
Dy. No. and date of submission 28764 dated 11-10-2022
Details of fee submitted Fee for revised stability batches not submitted
The proposed proprietary name / brand name CILSNIM 500mg Injection
Pharmaceutical ingredient (API) per unit
Imipenem monohydrate eq. to
imipenem…………….500mg
Cilastatin Sodium eq. to Cilastatin ……………500mg
Name and address of API manufacturer. M/s ACS DOBFAR S.p.A Viale Addetta 2a/12-3/5 20067
Tribiano, Milano- Italy
Summarized information related to nomenclature, structure,
submitted.
controls, tests for impurity & related substances,
specifications, analytical procedures and its verification,
drug substance
Real time: Temp.: 30°C ± 2°C, RH: 65% ± 5% for 36
month
Accelerated: Temp.: 40°C ± 2°C, RH: 75% ± 5%for 6
months
Batches: (990068 8004 2, 990068 8005 2, 990068 8006 2)
Pharmaceutical equivalence and comparative The Firm has performed pharmaceutical equivalence of
dissolution profile their developed formulation Cinam 500mg injection (B
#22A338) with reference product Cilapen 500mg Injection
Batch No: CP200034 by Bosch Pharmaceuticals. The
results showed that both test and reference products were
comparable.
Manufacturer of API M/s ACS DOBFAR S.p.A Viale Addetta 2a/12-3/5 20067 Tribiano,
Milano- Italy.
API Lot No. 990068-0008-E1
Description of Pack White to pale yellow color powder filled in clear glass vial, packed in Unit
(Container closure system) carton (1’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 22A337 22A338
Batch Size 5550 vials 5550 vials
No. of Batches 02
8. Approval of API/ DML/GMP certificate of API Copy of GMP certificate issued by Italian
manufacturer issued by concerned regulatory pharmaceutical Agency valid till 26/03/2025 is
authority of country of origin. submitted.
approval from DRAP (in case of import). import of and attested ADC (I&E) DRAP,
Islamabad dated 02-06-2021 for Imipenem and
cilastatin sodium sterile Batch No. 990068 0008 E1.
chromatograms, and summary data sheets.
etc.
11. Compliance Record of HPLC software 21CFR Firm has submitted Compliance Record of HPLC
& audit trail reports on product testing software 21CFR
and humidity monitoring of stability chambers temperature and humidity monitoring of real time
(real time and accelerated) and accelerated stability chambers.
Remarks OF Evaluator:
 The diluent for reconstitution used by the firm is 10ml WFI while innovator and reference product
recommend 10ml 0.9% NaCl injection.
 Firm is using 1081mg/ vial which is not justified keeping in view both drug substances are
available as salt form where 530mg imipenem monohydrate is equivalent to 500 mg imipenem and
530 mg cilastatin sodium salt is equivalent to 500mg cilastatin. Furthermore, the COA of API
depicts that the maximum percentage of both API could be 96.6% (48.3 % of individual API).
Discussion: Registration Board was apprised that the firm has submitted response against the above
mentioned observations on the day of meeting in which firm has submitted that in BMR they have mentioned
10ml WFI as diluent, however from now onwards they will use 10ml 0.9% NaCl solution as diluent as per
the recommendations of innovator’s product. Furthermore, the firm has also submitted calculation for fill
weight of drug substance in the vials in which they have taken sodium contents as per innovator’s product
claim instead of using sodium contents as per the drug substance.
Decision: Approved.
 Firm shall submit full fee 75,000/- for revision of stability study data as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
 Firm shall submit compatibility study with the 0.9%NaCl solution as diluent along with BMR
of recently manufactured batches as evidence of use of the recommended diluent before
issuance of Registration letter and shall use 10ml 0.9% NaCl injection as diluent for the future
manufacturing of all registered drug products of applied formulation as well.
 Firm shall use correct fill weight per vial considering the sodium content as per the drug
substance manufacturer’s claim for the commercial batches and submit BMR of recently
manufactured batches as evidence of correct fill weight before issuance of Registration letter.
satisfactory capacity assessment of manufacturing and testing facility of M/s Global
Pharmaceuticals.
735. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals (Pvt) Ltd. 62-Industrial
Authorization Holder Estate, Kot Lakhpat Lahore.
Name, address of Manufacturing site. M/s Next Pharmaceuticals Products (Pvt) Ltd. Plot #
44 A&B, Sunder Industrial Estate, Raiwind Road
Lahore.
☐ Importer
(Contract manufacturing agreement between both
firms is provided)
GMP status of the firm CCL Pharmaceuticals: GMP certificate issued on the
basis of inspection conducted on 30-04-2019.
Next Pharmaceuticals: GMP certificate issued on the
basis of inspection conducted on 28-05-2019.
Evidence of approval of manufacturing Firm (M/s Next Pharmaceuticals) has submitted copy
facility of Issuance of DML letter dated 31-10-2016
specifying Tablet (General) section.
☐ Export sale
Dy. No. and date of submission Dy No. 3326 dated 28-01-2021
Details of fee submitted Rs.50,000/- Dated 29-12-2020
The proposed proprietary name / brand name Nomit Tablet 10mg
Strength / concentration of drug of Active Each oro-dispersible tablet contains:
Pharmaceutical ingredient (API) per unit Domperidone……10mg
Pharmaceutical form of applied drug Light green colored round biconvex shaped tablet
packed in Alu-PVC blister with leaflet and unit carton
Pharmacotherapeutic Group of (API) Anti-dopaminergic
Reference to Finished product specifications Innovator’s specs
Proposed Pack size 5’s, 10’s, 14’s, 20’s, 28’s, 30’s, 50’s, 100’s
Proposed unit price As per innovator
The status in reference regulatory authorities DOMPERIDONE ARROW 10 mg orodispersible
tablet (ANSM France Approved)
For generic drugs (me-too status) Domflash ORO Tablet 10mg of Next
Pharmaceuticals
Name and address of API manufacturer. Vasudha Pharma Chem Limited, Unit-II, Plot No. 79,
Jiawaharlal Nehru Pharma city Thanam village
Parawada, Mandal, Visakhapatanam Andhra Pradesh
India.
template. Firm has summarized information related
solubilities, physical form, manufacturers,
description of manufacturing process and controls,
impurities, specifications, analytical procedures and
its validation, batch analysis and justification of
system and stability studies of drug substance and
drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance
properties, solubilities, physical form, manufacturers,
30°C ± 2°C / 65 ± 5% RH for 60 months.
description, composition, pharmaceutical
analytical procedures, batch analysis, justification of
Comparative Dissolution Profile equivalence for all the quality tests for their product
against Motilium tablet by Aspin Pharma
Analytical method validation/verification of Firm has submitted report of validation of analytical
product method for the drug product.
Firm has submitted report of verification studies of
analytical method for the drug substance.
Manufacturer of API Vasudha Pharma Chem Limited, Unit-II, Plot No. 79, Jiawaharlal Nehru
Pharma city Thanam village Parawada, Mandal, Visakhapatanam Andhra
Pradesh India.
API Lot No. BDOM/1705124
Description of Pack
Alu-alu blister
Batch No. BU-0001 BU-0002 BU-0003
Batch Size 500,000 tablet 500,000 tablet 500,000 tablet
No. of Batches 03
1. Reference of previous approval of applications No inspection of Next Pharmaceuticals have been
with stability study data of the firm (if any) conducted on the basis of stability study data.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of License retention
manufacturer issued by concerned regulatory certificate (No. 1238/AP/DCA/2017) issued by Drugs
authority of country of origin. Control Administration Government of Andhra
Pradesh, dated 09-02-2018. The retention certificate
specifies that the validity of license has been permitted
till 30-12-2022.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice dated
approval from DRAP (in case of import). 27-07-2017 specifying purchase of 30Kg
Domperidone base.
attested respective documents like batches along with chromatograms, raw data sheets,
chromatograms, Raw data sheets, COA, COA and summary data sheets.
5. Compliance Record of HPLC software 21CFR Firm has performed initial testing using HPLC while
& audit trail reports on product testing the 3rd and 6th month stability testing using UV
method.
6. Record of Digital data logger for temperature Firm has submitted manual record of 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:

Justify the submission of application for contract Since, we are undergoing development / stability studies
manufacturing of tablet from a contract manufacturer for many products and the CTD data pf the subject
since the same section i.e. Tablet (general) section is product was available with contract acceptor as the
already available with CCL Pharmaceuticals. product is already registered for Next pharma with brand
name “Domflash”, registration number 084816. We
hereby solicit that our concern and option may please be
considered and registration of drug may please be
approved.
The contract manufacturing policy published vide SRO
152(I)/2014 dated 4th March 2014 does not allow
contract manufacturing in such case.
Provide details regarding number of already registered Firm has submitted that currently they have registration
products of M/s CCL Pharmaceuticals on contract of 20 products on contract manufacturing. Other than
manufacturing basis along with total number of approved these 20 active products, firm has requested for
sections. cancellation of 17 other products that are also registered
in the name of M/s CCL Pharmaceuticals on contract
manufacturing basis. Firm has currently 6 active
sections.
Submit data in section 3.2.S.4.3 as per the guidance Firm has submitted that domflash-oro tablet is marketed
document approved by Registration Board which since 2018 having registration number 084816. Firm has
specifies that “Analytical Method Verification studies now submitted protocols for the verification studies of
including specificity, accuracy and repeatability (method the drug substance dated 07-04-2021.
precision) performed by the Drug Product manufacturer Firm has not yet performed verification studies of the
for both compendial as well as non-compendial drug analytical procedure of drug substance. Further all the
substance(s) shall be submitted” Further specify how the analysis of drug substance was carried out without
testing of drug substance was carried out without verification of the analytical method.
performing verification studies.
Justify how the stability studies of drug substance Firm has again submitted stability study data in which
submitted in section 3.2.S.7.3 shows different results for the results at initial time point is same for real-time and
same batch at initial time point of accelerated and real accelerated stability data.
time stability studies.
Justify why the formulation submitted in section 3.2.P.1 Firm has submitted that Domflash -oro tablet is an
has different qualitative composition as compared to the established formulation which is being marketed since
innovator / reference product. 2018having registration number 084816. There is no
critical and significant side-effect observed till date.
COAs of three ongoing commercial batches is attached.
Firm has not submitted any justification of having a
different master formulation as compared to the
innovator / reference product.
Provide detailed method along with analytical details Firm has submitted that Domflash -oro tablet is an
how the drug-excipient compatibility studies were established formulation which is being marketed since
performed. 2018having registration number 084816. There is no
critical and significant side-effect observed till date.
COAs of three ongoing commercial batches is attached.
Firm has different master formulation as compared to the
innovator / reference product and the firm has also not
performed any compatibility studies.
Specify details including batch number and Test product:
manufacturing date of the reference / comparator product Batch No. BU-0014
against which pharmaceutical equivalence is performed. Mfg date: 09-2018
Innovator product
Name: Motilium manufactured by Janssen Cilag Italy
Batch No. 18JQ230
Mfg date: 10-2018
Pharmaceutical equivalence has been performed on
batch manufactured on 09-2018 while stability study was
initiated on batches manufactured earlier on 02-2018
Justify the results of disintegration time above 1 minute Firm has submitted that based on WHO guidelines,
since USFDA Guidance for Industry on Orally Revision of monograph on tablets for additional in
Disintegrating Tablets specifies that “Based on the international pharmacopoeia dated March 2011 mentions
original product rationale and Agency experience, we disintegration time within 3 minutes. As our product is
recommend that, in addition to the original definition, non pharmacopoeial so we are using this WHO
ODTs be considered solid oral preparations that guidelines.
disintegrate rapidly in the oral cavity, with an in-vitro
disintegration time of approximately 30 seconds or less, The quoted reference by the firm is for dispersible tablet
when based on the United States Pharmacopeia (USP) while the applied formulation is orally disintegrating /
disintegration test method or alternative.” oro-dispersible tablet.
Justify why dissolution test was not performed during Firm has submitted that dissolution test is not applicable
pharmaceutical equivalence study. for oro-dispersible tablets
“USP general chapter <1711> oral solid dosage forms -
dissolution testing” recommends dissolution testing.
Justify why comparative dissolution profile is not Firm has submitted that dissolution test is not applicable
performed. for oro-dispersible tablets
“USP general chapter <1711> oral solid dosage forms -
dissolution testing” recommends dissolution testing.
Justify the drug product specifications without the test of Firm has submitted that USP general chapter <1711>
dissolution, since dissolution test is recommended for oral solid dosage forms – dissolution testing does not
oro-dispersible tablets in USP general chapter <1711> include dissolution test.
oral solid dosage forms - dissolution testing.
However the said general chapter recommends
dissolution testing for oro dispersible tablet.
The analytical procedures of drug product (section Domflash 10mg tablet orodispersible tablet was
3.2.P.5.2) specifies both UV as well as HPLC method for developed in house for testing on UV and HPLC. For
identification as well as assay testing of the drug product. batch release and stability studies both methods are
Clarification is required regarding which method will be validated.
used for testing of the product for batch release and
stability studies.
The stability batches were manufactured in February / The product has been developed and marketed earlier as
Mach 2018 while the analytical method for drug product per previous practice. Now we have performed
was validated on 09-2019 and 12-2019. Justify how the validation studies as per requirement and the results
testing of these batches were carried out without obtained from non-validated method were found same as
validating the analytical method. that of validated method with no deviations.
Justify why disintegration test was not performed during Initially disintegration test was not performed, but now
stability studies. as per updated requirements disintegration test is
incorporated in the testing and implemented on all
batches till date.
The initial stability study testing was performed using Domflash 10mg tablet orodispersible tablet was
HPLC method while the 3rd and 6th month stability developed in house for testing on UV and HPLC. For
testing was performed using UV method. Justify why the batch release and stability studies both methods are
analytical method was changed during the stability validated.
studies.
The submitted record of data logger of stability chambers Initially manual monitoring of temperature and humidity
show only 2 temperature and humidity record readings was done. Due to manual monitoring, recording the
per day (i.e. 09:00-11:00 and 15:00-17:00). Justify how temperature and humidity was taken twice a day.
only two readings per day can demonstrate the Our system is now upgraded and we have successfully
temperature and humidity control throughout the day. installed digital data logger. With data logger monitoring
The submitted record of data logger of stability chambers of temperature and humidity was taken after every 5
show record of working days only, while there is no minutes.
record available for weekends (i.e. Saturday and Sunday) The submitted record of data logger is of year 2020 while
and other public holidays (i.e. Eid holidays). Justify why the stability batches were kept in chamber in March
there was no mechanism for recording temperature and 2018.
humidity readings during the off days and how stability
studies can be concluded without having the capacity to
identify any deviation in temperature and humidity in the
stability chambers.
Registration Board after thorough deliberation and keeping in view the review of innovator product,
guidelines of USFDA for orally disintegrating tablets and the recommendations of USP general chapter
<1711> oral solid dosage forms - dissolution testing decided that since the contract manufacturer i.e. M/s
Next Pharmaceuticals is also manufacturing the same product for its own use therefore the technical queries
and onservations on the contract manufactured product shall also apply on the self manufactured product of
the firm. Based on the discussion, Board decided as under:
 Submission of product development and stability study data of the recently manufactured batches by
M/s Next Pharmaceuticals Products (Pvt) Ltd since their formulation is qualititaively different from
that of the innovator product and the firm has not performed drug-excipient compatability studies,
the acceptance criteria of disintegration test is is more than 1 minute while for oro-dispersible tablets
USFDA recommends disintegration time of less than 30 seconds and the finished product
specifications or product development studies does not include dissolution test which is
recommended in USP general chapter <1711>.
 Scientific justification of having a master formulation which is qualitatively different from that of
innovator product without performance of drug-excipient compatibility studies
 Scientific rational for the adaptation of acceptance criteria of disintegration test i.e. more than 1
minute while for oro-dispersible tablets USFDA recommends disintegration time of less than 30
seconds.
 Scientific rational for not performing dissolution test during product development studies, batch
release as well as during stability studies while the USP general chapter <1711> oral solid dosage
forms - dissolution testing recommends dissolution testing for orodispersibe tablets.
1. Registration Board after thorough deliberation No response from the manufacturer M/s Next
and keeping in view the review of innovator Pharmaceuticals have been received in this regard.
product, guidelines of USFDA for orally
disintegrating tablets and the recommendations of
USP general chapter <1711> oral solid dosage
forms - dissolution testing decided that since the
contract manufacturer i.e. M/s Next
Pharmaceuticals is also manufacturing the same
product for its own use therefore the technical
queries and onservations on the contract
manufactured product shall also apply on the self
manufactured product of the firm
2. Submission of product development and stability Firm has not submitted any product development
study data of the recently manufactured batches data or revised formulation / composition, drug-
by M/s Next Pharmaceuticals Products (Pvt) Ltd excipient compatability studies, pharmaceutical
since their formulation is qualititaively different equivalence and CDP studies.
from that of the innovator product and the firm has A Brief pharmaceutical development report has
not performed drug-excipient compatability been submitted by CCL pharmaceuticals while the
studies, the acceptance criteria of disintegration product manufacturer is Next Pharmaceuticals.
test is is more than 1 minute while for oro-
dispersible tablets USFDA recommends Moreover firm has submitted stability study data of
disintegration time of less than 30 seconds and the three batches in which the first batch was
finished product specifications or product manufactured in May 2021 while the 307th
development studies does not include dissolution meeting of Registration Board in which this case
test which is recommended in USP general was considered, was conducted on 8,9 and 10 th
chapter <1711>. June 20221.
3. Scientific justification of having a master No response submitted by the firm
formulation which is qualitatively different from
that of innovator product without performance of
drug-excipient compatibility studies
4. Scientific rational for the adaptation of acceptance No response submitted by the firm
criteria of disintegration test i.e. more than 1
minute while for oro-dispersible tablets USFDA
recommends disintegration time of less than 30
seconds.
5. Scientific rational for not performing dissolution No response submitted by the firm
test during product development studies, batch
release as well as during stability studies while the
USP general chapter <1711> oral solid dosage
forms - dissolution testing recommends
dissolution testing for orodispersibe tablets.
Firm has submitted another response dated 21-11-2022 in which the firm has submitted stability study data
of 3 newly manufactured batches for the drug product manufactured from same source of API. Firm has also
perfomed dissolution test on the newly submitted data. The details of the stability data is as under:
Manufacturer of API Vasudha Pharma Chem Limited, Unit-II, Plot No. 79, Jiawaharlal Nehru
Pharma city Thanam village Parawada, Mandal, Visakhapatanam Andhra
Pradesh India.
API Lot No. BDOM/1902010
Description of Pack
Alu-alu blister
Batch No. BU-0053 BU-0054 BU-0055
Batch Size 38815 Packs 39488 Packs 39066 Packs
API Lot No. BDOM/1902010 BDOM/2105066 BDOM/2105066
No. of Batches 03
Decision: Approved.
 Firm shall submit fee 75,000/- for revision of stability study data as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
736. Name, address of Applicant / Marketing M/s Farm Aid Pharmaceuticals, 3/2 Phase I &
Authorization Holder II Hattar, Industrial Estate, Hattar.
Name, address of Manufacturing site. M/s Cure Laboratories (Pvt) Ltd. Plot # 11-12,
Street # NS-2, RCCI Industrial Estate, Rawat
Islamabad.
☐ Importer
dated 19-10-2020.
Cure Laboratories dated 18-02-2021 based on the
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of
Drug Manufacturing License of M/s Cure
Laboratories (Pvt) Ltd dated 05-03-2019
specifying Dry Powder suspension
(Cephalosporin) section.
☐ Export sale
The proposed proprietary name / brand name FOFAM 100mg/5ml Dry Suspension
Strength / concentration of drug of Active Each 5ml of reconstituted suspension Contains:
Pharmaceutical ingredient (API) per unit Cefixime as trihydrate………100mg
Pharmaceutical form of applied drug Off white powder filled in amber colored glass
bottle
Pharmacotherapeutic Group of (API) Cephalosporin Antibiotic
Proposed Pack size 30 ml, 60ml
The status in reference regulatory authorities Cefixime suspension (USFDA Approved)
For generic drugs (me-too status) Cefim suspension by Hilton
Name and address of API manufacturer. Pharmagen Limited. Kot Nabi Bukshwala, 34 Km,
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
product against Cefspan dry suspension.
Manufacturer of API Pharmagen Limited. Kot Nabi Bukshwala, 34 Km, Ferozepur Road, Lahore.
API Lot No. 00243/178/2019
Description of Pack
Amber color glass bottle
Batch No. 19001 19002 19006
Batch Size 5000 bottles 5000 bottles 5000 bottles
No. of Batches 03
1. Reference of previous approval of applications No previous product specific inspectinon of the
with stability study data of the firm (if any) firm has been conducted.
authority of country of origin.
2019. The GMP certificate was granted based on
approval from DRAP (in case of import). dated 13-11-2019 specifying purchase of 25Kg
Cefixime (micronized).
data sheets etc.
5. Compliance Record of HPLC software 21CFR &
Evaluation by PEC:

Justify the analytical procedure and validation studies of Previously the QC department not following USP
drug substance in which the injection volume is 20µl and monograph for analytical method verification studies.
the retention time is around 5 minutes and the total run That’s why there were deviations from USP monograph
time is 7 minutes, while as per USP monograph, the like injection volume were taken as 20uL and run time as
injection volume is 10 µl and the retention time is 10 min. 7 minutes. Therefore we have re-performed the
Justify how you have deviated from the USP monograph analytical method validation studies in line with USP
and performed verification studies. monograph and the analytical method verification report
is attached herewith.
Firm has not justified their previous practice.
Moreover the newly submitted verification studies
are not as per ICH and USP recommendations and
also does not specify any date on which these studies
were conducted.
As per the analytical procedure of drug substance, the Previously the QC department not following USP
concentration of standard solution is 0.2mg/ml while you monograph for analytical method verification studies.
have defined 10ppm solution as 100% solution in That’s why there were deviations from USP monograph
accuracy studies. Justify how your verification studies like single reading of a solution among two analysts.
are representative of the same analytical procedure. The newly submitted verification studies are not as
per ICH and USP recommendations and also does not
specify any date on which these studies were
conducted. Moreover the specificity studies does not
specify the solution concentration.
You have specified that 30ml bottle containing cefixime Firm has submitted that we have followed cefspan
powder for suspension is to be reconstituted with 20ml 100mg/5ml powder for oral suspension as our innovator
water for injection. Justify how this reconstitution will brand for product development.
yield similar concentration of the drug as hat of the The innovator product is available as 50ml, 75ml and
innovator product. 100ml bottle only.
Justify why the test for uniformity of dosage unit is not Firm has revised the specifications along with
added in drug product specification as recommended in submission of fee PKR 7500/-vide slip number
USP monograph. Revise your product specifications in 6290135711 dated 24-01-2022.
line with USP monograph along wih submission of fee
for revision of specifications. Moreover, the new method again does not provide
detailed method of sample solution preparation.
Submit exact details of the assay preparation since the Firm has revised the specifications without submission
words “Reconstitute sample as directed n the labelling” of any fee. Moreover, the new method again does not
should not be used in the method adopted by a firm. provide detailed method of sample solution
Instead provide details about the exact diluent along with preparation.
volume in which reconstitution is to be carried out.
Justify the alternate method for assay testing of the drug We haven’t used any alternate method or analysis of
product which is based on UV analysis. finished product. The UV method for assay was
submitted mistakenly.
You have submitted the results of verification studies of Previously the QC department not following USP
drug substance in section 3.2.P.5.3 under the heading of monograph for analytical method verification studies.
verification studies of the drug product. Justify how same That’s why there were deviations from USP monograph.
results for all the parameters can be achieved for drug Therefore, we have re-performed the analytical method
substance and drug product. validation studies.
The submitted studies again show similar results
from that of drug substance verification studies.
Moreover, the HPLc chromatograms show 1uL
injection volume and various chromatograms have
been printed before the execution time of the relevant
chromatogram.
Justify the significant difference in assay for batch No. The accelerated stability studies of the Batch No. 19002
19002 in accelerated stability studies where the assay in which the assay declined from 110% at initial month
declined from 110% at initial time point to 99.03% after and 99.03% at 6th month, this may be due to mishandling
6 months. This difference is considered to be significant by the analyst or may be due to dilution factor. If our
change as per the ICH guidelines, justify how your product is unstable then same trend should be in other
stability studies for this batch may be considered batches of this product. Other two batches are not
acceptable in the light of ICH guidelines keeping in view showing this trend it clearly depicts the mishandling or
that the real time stability studies are also available for 9 wrong dilution by the analyst.
months and the same trend is also observed in real time The response of the firm regarding mishandling or
stability studies. wrong dilution by the analyst raise question on the
complete data and testing since the firm is also not
complying USP specifications and also not performed
the verification studies.
Justify why the assay test is performed using UV method We have checked the batches of Fixikef 100mg/5ml dry
while the method of analysis of drug substance suspension on HPLC as well on that time before release
manufacturer, innovator product and USP monograph is of the batches. We have performed on UV for
based on HPLC method. Furthermore, the verification verification of the results only. Due to some mis-
studies were also conducted for HPLC method. Justify understanding the UV report was submitted.
how you have released the commercial batches without The firm in its response in a question above stated
testing the product as per USP specifications and also that “We haven’t used any alternate method or analysis
performed stability studies. of finished product. The UV method for assay was
submitted mistakenly”. The response of the firm is
contradictory among different points.
Documents for the procurement of API with approval Firm has submitted copy of commercial invoice (Invoice
from DRAP (in case of import). # 1013, customer PO# NIL, Proforma invoice No. PL/P-
INV/HO/663, DN No. 1013) dated 13-11-2019
specifying purchase of 25Kg Cefixime (micronized).
However, the invoice submitted by the firm does not
seems to be real and may require to be verified.
Compliance Record of HPLC software 21CFR & audit Firm has submitted that they have submitted 21 CFR
trail reports on product testing. compliance report in Fofam 100mg/5ml suspension file.
However, audit trail report was not submitted.
You have specified that the capacity of double cone We have initially sieved all the ingredients through sieve
mixer for dry suspension is 200Kg, while the batch size # 30 and then loaded into mixer then run for 45 minutes
for which stability data is submitted is 85Kg. Justify how at 30 RPM. Then we intimated for sampling for QC
uniform mixing was carried out using a mixer of two analysis. QC has tested the sample and released the batch
times higher capacity than the batch size. for filling. Our mixing method is validated for this batch
size and all the batches are showing the results within the
specified limits. Therefore uniform mixing of 85Kg can
be done in a 200Kg capacity.
 Scientific justification for testing commercial batches of the drug product using specifications
 Scientific justification for having drug product specifications and testing method different from that
specified in USP monograph.
 Scientific justification for the analytical method verification studies of the drug product which is not
performed as per ICH guidelines.
 Scientific justification for stability testing of the product using UV method which is not
recommended by USP monograph.
 Submission of stability study data of three commercial batches in section 3.2.P.8.3 as per the 6-points
checklist provided in Form 5-F guidance document (PE&R/GL/AF/004) approved by the
Registration Board.
Sr. No Reason for deferment Respose by the firm
1. Scientific justification for testing commercial batches We have performed all the tests of the finished
of the drug product using specifications different from products of the commercial batches Fixikef
that specified in USP monograph. 100mg/5ml Suspension as per USP Monograph
but during typing of Reports our analyst forget
to mention all the tests / parameters on the
Finished Product Reports. Now we have
corrected the COAs of the Finished Products of
these Commercial Batches of Fixikef
100mg/5ml Suspension and a copy of the
reports are submitted.
2. Scientific justification for having drug product Initially there were some mistakes in the
specifications and testing method different from that Specifications and Testing Method of the
specified in USP monograph. finished product. Now we have corrected the
Specifications and SAP as per Current USP
Monograph and a copy of Specification and
SAP of Fixikef 100mg/5ml Suspension is
submitted.
The revised specifications specify that
revision number is 00 and the amendment
history also does not show any changes in
specifications.
3. Scientific justification for the analytical method We have performed all the parameters of
verification studies of the drug product which is not method verification studies of finished product
performed as per ICH guidelines. but there may be some variation from ICH
Guideline due handling from the analyst or may
be dilution factor.
Therefore, we will be careful next time and try
to perform as per ICH Guidelines.
4. Scientific justification for stability testing of the Initially there were some mistakes our Quality
product using UV method which is not recommended Control end that they haven’t follow USP
by USP monograph. monograph in real sense and perform stabilities
on UV Spectrophotometer.
When we realized this mistake we have
performed remaining stability time points on
HPLC Spectrophotometer.
We enclosed a copy of stability of remaining
time points performed on HPLC
Spectrophotometer.
Firm has now submitted HPLC chromatograms
for assay testing dated 28-10-2021 in which
only 1 standard injection was used and the
calculation formula was also not as per USP.
Moreover firm has submitted HPLC data of 28-
10-2021 while 316th meeting in which this case
was dicusedd was conducted in March 2022.
5. Submission of stability study data of three commercial Firm has submitted audit trail report of 2022 and
batches in section 3.2.P.8.3 as per the 6-points digital data logger record of stability chambers.
checklist provided in Form 5-F guidance document
(PE&R/GL/AF/004) approved by the Registration
Board.
Approved.
capacity assessment of manufacturing and testing facility of M/s Cure Laboratories (Pvt) Ltd.
Plot # 11-12, Street # NS-2, RCCI Industrial Estate, Rawat Islamabad.
 Firm shall submit record of testing of recently manufactured commercial batches as per USP
monograph before issuance of Registration letter.
737. Name, address of Applicant / Marketing M/s Farm Aid Pharmaceuticals, 3/2 Phase I &
Authorization Holder II Hattar, Industrial Estate, Hattar.
Islamabad.
☐ Importer
dated 19-10-2020.
specifying Dry Powder suspension
☐ Export sale
The proposed proprietary name / brand name FOFAM 200mg/5ml Dry Suspension
bottle
Proposed Pack size 30 ml, 60ml
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
product against Cefspan 200mg/5ml dry
suspension.
API Lot No. 00243/178/2019
Description of Pack
Batch No. 19003 19007 20002
No. of Batches 03
data sheets etc.
Evaluation by PEC:

Justify the analytical procedure and validation studies of Previously the QC department not following USP
drug substance in which the injection volume is 20µl and monograph for analytical method verification studies.
the retention time is around 5 minutes and the total run That’s why there were deviations from USP monograph
time is 7 minutes, while as per USP monograph, the like injection volume were taken as 20uL and run time as
injection volume is 10 µl and the retention time is 10 min. 7 minutes. Therefore we have re-performed the
Justify how you have deviated from the USP monograph analytical method validation studies in line with USP
and performed verification studies. monograph and the analytical method verification report
is attached herewith.
Firm has not justified their previous practice.
Moreover the newly submitted verification studies
are not as per ICH and USP recommendations and
also does not specify any date on which these studies
were conducted.
As per the analytical procedure of drug substance, the Previously the QC department not following USP
concentration of standard solution is 0.2mg/ml while you monograph for analytical method verification studies.
have defined 10ppm solution as 100% solution in That’s why there were deviations from USP monograph
accuracy studies. Justify how your verification studies like single reading of a solution among two analysts.
are representative of the same analytical procedure. The newly submitted verification studies are not as
per ICH and USP recommendations and also does not
specify any date on which these studies were
conducted. Moreover, the specificity studies does not
specify the solution concentration.
Justify the total fill weight of 14.940gm per bottle, since We have used quantities of all the excipients are same
you have mentioned exactly same quantities of each except that of sugar, which adjusted in Fixikef
excipient and have used double quantity of the drug 200mg/5ml DS for double quantity of API.
substance as that provided in 100mg/5ml suspension.
You have specified that 60ml bottle containing cefixime Firm has submitted that the 60ml bottle contains 17.20g
powder for suspension is to be reconstituted with 20ml powder and it will be reconstituted using 20ml sterile
water for injection. Justify how this reconstitution will water for injection.
yield similar concentration of the drug as hat of the
innovator product.
Justify why the test for uniformity of dosage unit is not Firm has revised the specifications along with
added in drug product specification as recommended in submission of fee PKR 7500/-vide slip number
USP monograph. Revise your product specifications in 6290135711 dated 24-01-2022.
line with USP monograph along wih submission of fee
for revision of specifications. Moreover, the new method again does not provide
detailed method of sample solution preparation.
Submit exact details of the assay preparation since the Firm has revised the specifications without submission
words “Reconstitute sample as directed n the labelling” of any fee. Moreover, the new method again does not
should not be used in the method adopted by a firm. provide detailed method of sample solution
Instead provide details about the exact diluent along with preparation.
volume in which reconstitution is to be carried out.
Justify the alternate method for assay testing of the drug We haven’t used any alternate method or analysis of
product which is based on UV analysis. finished product. The UV method for assay was
submitted mistakenly.
You have submitted the results of verification studies of Previously the QC department not following USP
drug substance in section 3.2.P.5.3 under the heading of monograph for analytical method verification studies.
verification studies of the drug product. Justify how same That’s why there were deviations from USP monograph.
results for all the parameters can be achieved for drug Therefore, we have re-performed the analytical method
substance and drug product. validation studies.
The submitted studies again show similar results
from that of drug substance verification studies.
Moreover, the HPLc chromatograms show 1uL
injection volume and various chromatograms have
been printed before the execution time of the relevant
chromatogram.
Justify the significant difference in assay for batch No. The accelerated stability studies of the Batch No. 2002 in
20002 in accelerated stability studies where the assay which the assay declined from 103% at initial month and
declined from 103% at initial time point to 97.47% after 97.47% at 6th month, this may be due to mishandling by
6 months. This difference is considered to be significant the analyst or may be due to dilution factor. If our
change as per the ICH guidelines, justify how your product is unstable then same trend should be in other
stability studies for this batch may be considered batches of this product. Other two batches are not
acceptable in the light of ICH guidelines. showing this trend it clearly depicts the mishandling or
wrong dilution by the analyst.
The response of the firm regarding mishandling or
wrong dilution by the analyst raise question on the
complete data and testing since the firm is also not
complying USP specifications and also not performed
the verification studies.
Justify why the assay test is performed using UV method We have checked the batches of Fixikef 100mg/5ml dry
while the method of analysis of drug substance suspension on HPLC as well on that time before release
manufacturer, innovator product and USP monograph is of the batches. We have performed on UV for
based on HPLC method. Furthermore, the verification verification of the results only. Due to some mis-
studies were also conducted for HPLC method. Justify understanding the UV report was submitted.
how you have released the commercial batches without The firm in its response in a question above stated
testing the product as per USP specifications and also that “We haven’t used any alternate method or analysis
performed stability studies. of finished product. The UV method for assay was
submitted mistakenly”. The response of the firm is
contradictory among different points.
Documents for the procurement of API with approval Firm has submitted copy of commercial invoice (Invoice
from DRAP (in case of import). # 1013, customer PO# NIL, Proforma invoice No. PL/P-
INV/HO/663, DN No. 1013) dated 13-11-2019
specifying purchase of 25Kg Cefixime (micronized).
However, the invoice submitted by the firm does not
seems to be real and may require to be verified.
Compliance Record of HPLC software 21CFR & audit Firm has submitted that they have submitted 21 CFR
trail reports on product testing. compliance report in Fofam 100mg/5ml suspension file.
However, audit trail report was not submitted.
Record of Digital data logger for temperature and Firm has submitted that they have submitted temperature
humidity monitoring of stability chambers (real time and and humidity logger report in Fofam 100mg/5ml
accelerated) suspension file. However, data logger report was not
submitted.
You have specified that the capacity of double cone We have initially sieved all the ingredients through sieve
mixer for dry suspension is 200Kg, while the batch size # 30 and then loaded into mixer then run for 45 minutes
for which stability data is submitted is 85Kg. Justify how at 30 RPM. Then we intimated for sampling for QC
uniform mixing was carried out using a mixer of two analysis. QC has tested the sample and released the batch
times higher capacity than the batch size. for filling. Our mixing method is validated for this batch
size and all the batches are showing the results within the
specified limits. Therefore uniform mixing of 51Kg can
be done in a 200Kg capacity.
 Scientific justification for stability testing of the product using UV method which is not
recommended by USP monograph.
Registration Board.

of the drug product using specifications different from products of the commercial batches Fixikef
that specified in USP monograph. 100mg/5ml Suspension as per USP Monograph
but during typing of Reports our analyst forget
to mention all the tests / parameters on the
Finished Product Reports. Now we have
corrected the COAs of the Finished Products of
these Commercial Batches of Fixikef
100mg/5ml Suspension and a copy of the
reports are submitted.
SAP of Fixikef 100mg/5ml Suspension is
submitted.
The revised specifications specify that
revision number is 00 and the amendment
history also does not show any changes in
specifications.
3. Scientific justification for the analytical method We have performed all the parameters of
verification studies of the drug product which is not method verification studies of finished product
performed as per ICH guidelines. but there may be some variation from ICH
Guideline due handling from the analyst or may
be dilution factor.
Therefore, we will be careful next time and try
to perform as per ICH Guidelines.
4. Scientific justification for stability testing of the Initially there were some mistakes our Quality
product using UV method which is not recommended Control end that they haven’t follow USP
by USP monograph. monograph in real sense and perform stabilities
on UV Spectrophotometer.
When we realized this mistake we have
performed remaining stability time points on
HPLC Spectrophotometer.
We enclosed a copy of stability of remaining
time points performed on HPLC
Spectrophotometer.
Firm has now submitted HPLC chromatograms
for assay testing dated 28-10-2021 in which
only 1 standard injection was used and the
calculation formula was also not as per USP.
Moreover firm has submitted HPLC data of 28-
10-2021 while 316th meeting in which this case
was dicusedd was conducted in March 2022.
Board.
Approved.
738. Name, address of Applicant / Marketing M/s Farm Aid Group Pharmaceuticals, 3/2
Authorization Holder Phase-I & II Hattar Industrial Estate Hattar,
Haripur.
Islamabad.
☐ Importer
dated 19-10-2020.
specifying Dry Powder vial (Cephalosporin)
section.
☐ Export sale
PKR 25,000/: 20-01-2022
The proposed proprietary name / brand name SOCEF 250mg Injection IM
Pharmaceutical ingredient (API) per unit Ceftriaxone (as sodium)……250mg
Pharmaceutical form of applied drug Sterile white to off white powder filled in
transparent glass vials
For generic drugs (me-too status) Aczon injection by Vision Pharma
Name and address of API manufacturer. Sinopharm Weiqida Pharmaceutical Co. Ltd. First
Medical Zone, Economic and Technological
Development Zone, Datong Shanxi. China
product.
against the comparator i.e. Oxidil 250mg Injection
of M/s Sami Pharma.
Manufacturer of API Sinopharm Weiqida Pharmaceutical Co. Ltd. First Medical Zone, Economic
and Technological Development Zone, Datong Shanxi. China
API Lot No. Q012002060
Description of Pack
Glass vials
Batch No. 20028 20029 20030
No. of Batches 03
manufacturer issued by concerned regulatory SX20180229) issued by CFDA China dated 06-06-
authority of country of origin. 2018. The GMP certificate is valid till 05-06-2023.
(sterile) dated 04-05-2020. The invoice is cleared
by AD (I&E) DRAP.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted audit trail report of 2022 and
audit trail reports on product testing 2021 but the audit trail report for the product
testing of the applied product is not provided.
Evaluation by PEC:

Submit differential fee for the registration of applied Firm has submitted fee challan for differential fee of PKR
product, since the notification for revision of fee vide 25,000 dated 20-01-2022.
SRO No. F.7-11/2012-B&A/DRA was published on 7th
Justify the drug substance specifications submitted in There was a typographic mistake that non-sterile was
section 3.2.S.4.1 which states that the material is non- mentioned and the assay limit was mentioned 98-102%.
sterile and the assay limit is 98 – 102% which is Actually, we have used sterile ceftriaxone sodium and just
contrary to that specified in USP monograph for filled in vials under aseptic conditions. Actual assay limit
ceftriaxone for injection. Furthermore, clarify whether for ceftriaxone sterile was NLT 795ug/mg on anhydrous
you have used sterile ready to fill drug substance or basis.
non-sterile ceftriaxone sodium. The assay limit defined by FPP manufacturer is NLT
795ug/mg, while the assay limit of API manufacturer
is NLT 840 ug/mg.
Justify how the drug substance batch No. Q012002060 At the time of import from the source SINO PHARM
was released on 18-05-2020 without performing CHINA, No vendor sample was provided by the Supplier.
sterility test since this test is mentioned in the drug Therefore, the container was opened in the sterile area
substance specifications as well as COA of drug under laminar flow hood and take sample for Chemical
substance manufacturer. Justify how 200kg material and Microbiological Tests. The chemical test was
was released for production without performing sterility conducted at the spot and microbiological test (sterility)
test. initiated by same day but on the basis of chemical analysis
and the nature of sterile powder that can’t be waited for
sterility completion as sterility is for 14 days, we have
decided to release the lot for production use conditionally
for Filling and Sealing only. The condition was that after
complying sterility we can label or pack the filled vials.
On the Release Report the Analyst Forget to mention
Conditionally Released, Now corrected the Release
report and is attached. The Endotoxin and sterility reports
are also attached herewith.
Justify why the pharmaceutical equivalence study does Firm has again submitted pharmaceutical equivalence
not include complete testing of the drug product and the study report with oxidil injection in which more tests are
innovator product as per USP specifications. Justify also incorporated in the test report without justifying the
how only pH and assay test can demonstrate previously submitted studies.
pharmaceutical equivalence.
Justify why the pharmaceutical equivalence is We have performed Pharmaceutical Equivalence Studies
performed against comparator product instead of testing with Comparator Product (Oxidil 250mg Injection IM of
against the innovator product. Sami Pharmaceuticals) because we are unable to arrange
innovator pack of Rocephin 250mg Injection IM due to
shortage of supply. Kindly accept the Pharmaceutical
Equivalence Studies with Oxidil as an Exceptional Case
Please.
Justify your process validation protocols without any Firm has submitted revised process validation protocols
process for optimization of sterilization process and without justifying the previously submitted protocols.
sealing of vials etc. Further justify why complete
process validation is not performed since commercial
batches of the drug product have been manufactured by
the manufacturer.
Justify why the specifications of the drug product Firm has submitted revised specifications of the drug
(section 3.2.P.5.1) does not contain important tests as product without justifying the previously submitted
recommended by USP including test for constituted justifications.
solution, particulate matter in injection, crystallinity
and complete assay test.
Provide detailed testing method for the drug product as Firm has submitted revised specifications of the drug
per the USP specifications since the submitted method product without justifying the previously submitted
is not complete. Also submit fee for revision of justifications. However the revised method of analysis
specifications in the light of USP monograph. is also in variation to USP in terms of the assay test
since USP recommends two different type of test for
the assay and the sample solution preparation method
of USP is in mobile phase, while the firm is preparing
sample solution in 1% lignocaine.
Firm has also submitted fee PKR 7500 for revision of
specifications dated 18-01-2022.
Clarify the sample solution preparation method in your Break the tip of the Ampoule of Lignocaine 1% Solution
analysis which states “constitute ceftriaxone for for injection 2ml. Draw the Solution inside in syringe
injection in a volume of water corresponding to the (Almost drawable volume is 1.8ml). Then inject the
volume of solvent specified in the labelling”. Specify solution into the Niasef 250mg Injection IM Vial and
what is the exact volume in which reconstitution is to reconstitute for 5 minutes until clear solution is obtained.
be carried out instead of mentioning generalized Then leave the solution for 1-2 minutes to clear the
statements. bubbles inside, then take a fresh syringe and draw the
ceftriaxone solution into the syringe and inject through IM
route.
Firm has submitted method for administration of the
injection instead of providing detailed method for
sample solution preparation in assay method.
Justify how three commercial batches were released for Firm has not submitted any response
commercial use without performing complete tests as
The batches are released after 16-06-2020, while the We have initiated stability 02-06-2020 because our micro
stability studies were initiated on 02-06-2020. Justify Lab completed the stability of filled vials on 02-06-2020.
how the batch could be initiated for stability studies We have packed the required stability packs on same date
before the batch release. manually i.e. 02-06-2020 but remaining packing of whole
batch was carried out by production department on 16-06-
2020 and our QC Released the batch on 16-06-2020 after
checking retained packs received on 16-06-2020.
Justify why the test for bacterial endotoxin, sterility, Firm has not submitted any response
water contents, constituted solution etc is not performed
during stability studies since these tests are very critical
and are required to make assessment of the stability
profile and shelf life.
Justify the raw data sheets in which sample preparation Firm has still provided incomplete raw data sheets in
method is incomplete. which the calculation procedure is different from that
specified in the analytical method of the firm, moreover
firm is preparing sample solution in 1% lignocaine
contrary to the recommendations of USP.
Justify how only single value of peak area of standard Firm has not submitted any justification, instead
and sample is used to calculate the assay of drug provided new chromatograms in which 2 standard
product during stability studies. injections are used which is still not as per the
recommendations of USP.
Provide complete record of the stability testing of each Firm has again submitted data without any proper
batch with proper separators in a sequence instead of sequence again and the raw data sheets are also
separately providing the data without any sequence. incomplete since they only contain single value of
standard and sample area, further the potency of
standard used in raw data sheets are 830.4, while the
actual potency of standard as per COA submitted by
the firm is 843. Furthermore, the sample solution
prepared by the firm is in lignocaine contrary to USP
recommendations.
Justify the batch manufacturing record in which the This was a typographical mistake that the BMRs should
exact time of start and end of sterilization, filling of vial include Sterilization Start and End Time not mentioned.
and sampling etc is not mentioned. Actually the sterilization start and End time was noted on
the Sterilization Log book. Now we have corrected the
BMR and included Sterilization Start and End time.
 Scientific justification for assay limit as NLT 795ug/mg, while the assay limit of drug substance
manufacturer is NLT 840 ug/mg.
 Scientific justification how three commercial batches were released in the market without complete
testing as per USP monograph.
 Scientific justification why the test for bacterial endotoxin, sterility, water contents, constituted
solution etc is not performed during stability studies.
 Scientific justification how only single value of peak area of standard and sample is used to calculate
the assay of drug product during stability studies.
Registration Board.

1. Scientific justification for assay limit as NLT Initially we have followed USP Monograph for
795ug/mg, while the assay limit of drug substance testing of Ceftriaxone Sodium API and the limit
manufacturer is NLT 840 ug/mg. for Assay of Ceftriaxone Sodium was
795ug/mg. But after discussion with concerned
Assistant Director (AD) we have realized that
we should follow the narrow range for Assay of
Ceftriaxone Sodium. Therefore, we have
changed the Assay Limit and the new limit (as
per API Supplier Chinese Pharmacopeia) we
have adopted 840ug/mg for Assay of
Ceftriaxone Sodium. We will follow 840ug/mg
as Assay Limit for future API (Ceftriaxone
Sodium) lots testing.
of the drug product using specifications different from products of the commercial batches NIASEF
that specified in USP monograph. 250MG INJECTION IM as per USP
Monograph but during typing of Reports our
analyst forget to mention all the tests /
parameters on the Finished Product Reports.
Now we have corrected the COAs of the
Finished Products of these Commercial Batches
of NIASEF 250MG INJECTION IM and a copy
of the reports are attached herewith for your
review please.
SAP of Socef 250mg Injection IM is attached
herewith. We have already paid a Fee of RS
7500/- for change of Specifications of Socef
250mg Injection IM.
4. Scientific justification how three commercial batches We have performed all the tests of the finished
were released in the market without complete testing products of the commercial batches NIASEF
as per USP monograph. 250MG INJECTION IM as per USP
Monograph but during typing of Reports our
analyst forget to mention all the tests /
parameters on the Finished Product Reports.
Now we have corrected the COAs of the
Finished Products of these Commercial Batches
of NIASEF 250MG INJECTION IM and a copy
of the reports are attached herewith for your
review please.
5. Scientific justification why the test for bacterial We have performed all the tests of the stability
endotoxin, sterility, water contents, constituted batches at every interval of time but at the time
solution etc is not performed during stability studies. of typing of Stability Reports our analyst forget
to mention on stability sheets. Now after 9th
month we have performed all the parameters as
per USP Monograph and the results of stability
studies on 12th month 18th month and a current
time point is attached for your review and
evaluation.
6. Scientific justification how only single value of peak Initially we have performed stability studies
area of standard and sample is used to calculate the with a single value of standard and a sample but
assay of drug product during stability studies. when we realize our mistake than we have
corrected our studies with three standards and
two samples.
The stability data time points with 12th month,
18th month and current point is as per three
standards and two samples.
Firm is now using 2 standard injection.
Board.
Decision: Approved.
739. Name, address of Applicant / Marketing M/s Martin Dow Limited, Plot No. 37, Sector 19,
Authorization Holder Korangi Industrial Area, Karachi.
Name, address of Manufacturing site. M/s Vision Pharmaceuticals (Pvt) Ltd. Plot No. 22-
23, Industrial Triangle Kahuta Road Islamabad.
☐ Importer
pharmaceutical products between contract giver and
acceptor dated 02-08-2021 is submitted.
Vision Pharmaceuticals dated 25-03-2022 based on
inspection dated 11-02-2019. As per the certificate, it
was valid till 09-05-2022.
Evidence of approval of manufacturing Firm has submitted copy of letter of renewal of DML
facility of M/s Vision Pharmaceuticals DML No 000517
dated 07-06-2021. Firm has also submitted copy of
letter dated 09-12-2021 which specifies that CLB in
its 283rd meeting held on 28th October 2021 also
approved renewal of DML for Liquid Injectable
(LVP) General Section.
☐ Export sale
The proposed proprietary name / brand name JYTHON 600mg/300ml Infusion
Strength / concentration of drug of Active Each vial of 300ml Contains:
Pharmaceutical ingredient (API) per unit Linezolid…..…600mg
Pharmaceutical form of applied drug Liquid infusion
Pharmacotherapeutic Group of (API) Antibacterials for systemic use
Reference to Finished product specifications In-house specs
The status in reference regulatory authorities Zyvox IV (USFDA Approved)
For generic drugs (me-too status) Nezkil Infusion by Continental pharma
Name and address of API manufacturer. Optrix Laboratories Pvt Ltd. Survey No. 145/A &
147, Ramalingampally (V), Bommalaramaram (M),
Yadadri-Bhuvanagiri District Telangana India.
drug product.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Comparative Dissolution Profile equivalence for their product against Nezkil infusion
of Continental Pharma.
Manufacturer of API Optrix Laboratories Pvt Ltd. Survey No. 145/A & 147, Ramalingampally
(V), Bommalaramaram (M), Yadadri-Bhuvanagiri District Telangana India.
API Lot No. OP-LID/10/17/107
Description of Pack
Glass vials
Batch No. 1217901 1217902 1217904
No. of Batches 03
manufacturer issued by concerned regulatory 68951/TS/2021) issued by Drugs control
authority of country of origin. administration, Government of Telangana dated 20-
09-2021. The GMP certificate is valid till 19-09-2022.
approval from DRAP (in case of import). cleared dated 08-11-2017 specifying import of 50Kg
Linezolid. The invoice is cleared by AD (I&E) DRAP.
attested respective documents like batches along with raw data sheets, COA and
5. Compliance Record of HPLC software 21CFR Not applicable. Our HPLC system are not 21 CFR
& audit trail reports on product testing compliant.
6. Record of Digital data logger for temperature Firm has submitted record of digital data logger for
Evaluation by PEC:

1. Justify the manufacturing of 300ml glass vial Firm has also submitted copy of letter dated 09-12-2021
(linezolid 600mg/300ml Infusion), while your which specifies that CLB in its 283rd meeting held on 28th
approved manufacturing facility is “Liquid October 2021 also approved renewal of DML for Liquid
Injectable Vial SVP (General) section”. Injectable (LVP) General Section.
2. The drug substance manufacturer has The drug substance testing was done by UV method at that
specified HPLC test for assay of drug time, but currently we are using HPLC method for both
substance while the drug product API and product.
manufacturer has specified UV method for
assay of drug substance. Justify how drug
product manufacturer can adopt different test
for assay method from that recommended by
the drug substance manufacturer.
3. Submit COA of relevant batch of API used in Firm has submitted ADC attested commercial invoice for
the manufacturing of batches for which lot number OP-LID/10/17/107.
stability study data is submitted in section
3.2.P.8.3 from both drug substance
manufacturer as well as drug product
manufacturer in section 3.2.S.4.4, since you
have submitted COA of batch number OP-
LID/10/17/107 (Mfg date: 09-2017), while as
per the submitted import documents the lot
number of the API is OP-LID/07/18/077 (Mfg
date: 05-2018) and the three stability batches
are manufactured in 12-2017.
4. Innovator drug product is using sodium For pH adjustment we had mentioned HCL and sodium
hydroxide and/or hydrochloric acid for hydroxide in BMR. As our formulation is stable and upon
ataining the pH within a narrow range of 4.4- manufacturing the pH comes in limit as defined, and we
5.2 while your master formulation does not do not require HCl or Sodium hydroxide for pH
specify the use of any such ingredient. adjustment.
Justification is required in this regard.
5. Justify why the pharmaceutical equivalence Pharmaceutical equivalence study was done against
studies were conducted against the Nezkil of continental pharma as mentioned in DRAP 293rd
comparator product instead of using meeting we can use Reference or comparator product for
innovator / reference product. Further justify comparison and comparator product is among brand
why pharmaceutical equivalence does not leaders in Pakistan.
include all quality tests.
6. The pH of the product mentioned in section It was a typo error. Actual pH range is 4.4 to 5.5 and our
3.2.P.2.6 is 6.12 with a range of 5.0 to 7.0 results fall in it.
which is contrary to the limit defined in your
speifications. Justification is required in this
regard.
7. Justify why terminal sterilization is not Firm has submitted that they have performed terminal
performed for the said product although being sterilization and have also submitted copy of BMR.
the method of choice for sterilization.
8. Justify why the test for filled volume is not Filled volume test reports are now provided by the firm.
specified in the specifications of the drug
product although this test is recommended in
general monograph of official
pharmacopoeia.
9. Justify the pH of the drug product from 4.4 to Linezolid infusion batches kept on stability have pH
5.5 since the pH range recommended by the almost in the range of 4.4 to 4.8, and this is in limit of 4.4
innovator’s product is 4.4-5.2. to 5.2, However we will revise the pH limit as according
to innovator specs and will revise the testing SOP.
10. Justify the analytical method for assay testing Firm has submitted revised analytical procedures of the
of the drug product which is based on UV drug product dated 13-09-2021. As per the method, buk
method since the innovator’s product as well product is tested by UV method while filled vial are tested
as the drug substance manufacturer specify using HPLC method.
HPLC method for assay test. The revised method is signed on 13-09-2021 while the
stability studies were initiated on December 2017.
11. The container closure system of the innovator Stability is done in glass vial and it is stable. Also our glass
is “flexible plastic infusion bags in a foil vials are wrapped in laminated foil.
laminate overwrap” while your prduct is
packed in glass vial. Justify how your
container closure system can prevent the
product from exposure to the light.
12. Justify why the test of pH is not performed pH is not included in stability summary sheets, however
during stability studies. all testing is performed and mentioned in analysis
certificates. pH results added in stability summary sheet.
 Scientific justification for revised analytical procedures of the drug product dated 13-09-2021 in
which buk product is tested by UV method while filled vial are tested using HPLC method.
 Scientific justification how a revised method dated 13-09-2021 can represent the results of the
stability studies which were initiated in December 2017.
Sr. No. Reason for deferment Response by the firm
1. Scientific justification for revised analytical Testing of bulk batch is not regulatory requirement
procedures of the drug product dated 13-09-2021 so its testing is performed on UV (already validated
in which buk product is tested by UV method method), because after bulk testing product is
while filled vial are tested using HPLC method. released for filling while finished product is tested
on HPLC and product released for packing after
HPLC test.
2. Scientific justification how a revised method As this product is not phrmacopoeial so previously
dated 13-09-2021 can represent the results of the batches were tested according to UV method hence
stability studies which were initiated in December the submitted stability were tested according to
2017. previous methods.
Then we shifted to HPLC method effectively from
13-09-2021 for which we have revised our SOPs.
 Firm shall submit fee 7,500/- for revision of specifications as per notification No.F.7-11/2012-
 Firm shall submit data of HPLC testing on recently manufactured batches of the applied drug
product before issuance of Registration letter.
740. Name, address of Applicant / Marketing M/s Nagarsons Pharmaceuticals. Plot No. 34,
Authorization Holder St. No. NS-2, National Industrial Zone, Rawat,
Islamabad
Name, address of Manufacturing site. M/s Nagarsons Pharmaceuticals. Plot No. 34, St.
No. NS-2, National Industrial Zone, Rawat,
Islamabad
☐ Importer
GMP status of the firm Firm has submitted copy of DML number 000927
issued dated 04-06-2021 with effect from 19-02-
2021.
DML by way of formulation to M/s Nagarsons
Pharmaceuticals dated 07-06-2021 for following
sections:
1. Tablet (General)
2. Tablet (Psychotropic)
3. Capsule (General)
4. Cream /ointment/Lotion/Gel
☐ Export sale
The proposed proprietary name / brand name AZONAG 250mg Tablet
Strength / concentration of drug of Active Each film coated tablet contains:
Pharmaceutical ingredient (API) per unit Azithromycin (as dihydrate)………250mg
Pharmaceutical form of applied drug White to off white film coated tablet
Pharmacotherapeutic Group of (API) Macrolides
The status in reference regulatory authorities (USFDA Approved)
For generic drugs (me-too status) Orzit Tablet 250mg of M/s Martin Dow (Reg #
057294)
Name and address of API manufacturer. M/s Hebei Guolong Pharmaceutical Co. Ltd No. 9
Xingye Street, Shijiazhuang Economic and
Technological Development Zone, Hebei Province
China.
product.
for their product against the reference product i.e.
Zetamax 250mg Tablet of M/s Pfizer Pakistan.
Firm has submitted results of CDP in three
dissolution medium for their product against the
reference product i.e. Zetamax 250mg Tablet of
Manufacturer of API M/s Hebei Guolong Pharmaceutical Co. Ltd No. 9 Xingye Street,
Shijiazhuang Economic and Technological Development Zone, Hebei
Province China.
API Lot No. 210507019
Description of Pack
Alu-Alu blister
Batch No. T-004 T-005 T-006
No. of Batches 03
1. Reference of previous approval of applications Nagarsons Pharmaceutical is a new license facility
with stability study data of the firm (if any) hence no such inspection has been conducted.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of Drug Manufacturing
manufacturer issued by concerned regulatory License of Hebei Guolong Pharmaceutical Co. Ltd.
authority of country of origin. (No. JI20150058) issued by Hebei Provincial Drug
Administration dated 22-07-2020. The certificate is
approval from DRAP (in case of import). specifying purchase of 10Kg Azithromycin
dihydrate cleared dated 24-08-2021. The invoice is
cleared by AD (I&E).
attested respective documents like all batches along with UV spectra, raw data sheets,
chromatograms, Raw data sheets, COA, summary COA and summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not applicable. Our HPLC systems are not 21
audit trail reports on product testing CFR compliant
Evaluation by PEC:

1. Submit data in section 3.2.S.4.1 as per the Firm has submitted drug substance specifications and
guidance document approved by Registration analytical method from both API manufacturer as well as
Board which specifies that “Copies of the Nagarsons Pharma.
Drug substance specifications and analytical
procedures used for routine testing of the
Drug substance /Active Pharmaceutical
Ingredient by both Drug substance & Drug
Product manufacturer is required.”
2. Submit verification studies of the analytical Firm has submitted report of verification studies of the
method of drug substance in section 3.2.S.4.3. analytical method of drug substance.
3. Provide COA of relevant batch of drug Firm has submitted COA of relevant batch of drug
substance which is used in the manufacturing substance from API manufacturer as well as Nagarsons
of batches of drug product. Pharma.
4. Justify why pharmaceutical equivalence and We use Zetamax tablet by Pfizer because the innovator
CDP studies are performed against zetamax product is not available in the market in Pakistan.
tablet of Pfizer instead of using the
innovator’s product.
5. Provide raw data sheets for the calculation of Firm has submitted raw data sheets for the calculation of
results of dissolution test throughout the results of dissolution test throughout the stability studies
stability studies. using HPLC method.
6. Provide evidence of column oven which is Firm has not submitted evidence of HPLC along with
required to maintain temperature of 50° column oven.
7. Submit Batch Manufacturing Record of three Firm has submitted copy of Batch Manufacturing Record
stability batches. of three stability batches.
Deferred for submission of evidence of HPLC system along with column oven which is required to maintain
temperature of 50° for assay testing of drug product as per USP monograph.
Firm has submitted following documents:
 Copy of invoice from Prestigious Multi Enterprises for purchase of HPLC dated 12-01-2021.
 Firm has also submitted another copy of invoice from Prestigious Multi Enterprises dated 12-01-
2021 for purchase of HPLC column c-18 along with HPLC Column Oven.
 Firm has also submitted caliberation certificate from Galvano Scientific (Pvt) Ltd dated 12-04-2022
for caliberation of HPLC including its column oven set at 40 degree.
 Picture of an HPLC system with column oven set at 50 degree claimed to be placed in their QC lab.
Decision: Approved.
 Firm shall submit IQ, OQ and PQ of HPLC system along with column oven before issuance of
741. Name, address of Applicant / Marketing M/s Nagarsons Pharmaceuticals. Plot No. 34,
Authorization Holder St. No. NS-2, National Industrial Zone, Rawat,
Islamabad
Name, address of Manufacturing site. M/s Nagarsons Pharmaceuticals. Plot No. 34, St.
No. NS-2, National Industrial Zone, Rawat,
Islamabad
☐ Importer
GMP status of the firm Firm has submitted copy of DML number 000927
issued dated 04-06-2021 with effect from 19-02-
2021.
DML by way of formulation to M/s Nagarsons
Pharmaceuticals dated 07-06-2021 for following
sections:
1. Tablet (General)
2. Tablet (Psychotropic)
3. Capsule (General)
4. Cream /ointment/Lotion/Gel
☐ Export sale
The proposed proprietary name / brand name AZONAG 500mg Tablet
Pharmaceutical ingredient (API) per unit Azithromycin (as dihydrate)………500mg
Pharmaceutical form of applied drug White to off white film coated tablet
Pharmacotherapeutic Group of (API) Macrolides
For generic drugs (me-too status) Azomax Tablet 500mg of M/s Novartis Pakistan
(Reg # 045415)
Name and address of API manufacturer. M/s Hebei Guolong Pharmaceutical Co. Ltd No. 9
Xingye Street, Shijiazhuang Economic and
Technological Development Zone, Hebei Province
China.
product.
Azomax 500mg Tablet of M/s Novartis Pakistan.
reference product i.e. Azomax 500mg Tablet of
M/s Novartis Pakistan.
Manufacturer of API M/s Hebei Guolong Pharmaceutical Co. Ltd No. 9 Xingye Street,
Shijiazhuang Economic and Technological Development Zone, Hebei
Province China.
API Lot No. 210507019
Description of Pack
Alu-Alu blister
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of applications Nagarsons Pharmaceutical is a new license facility
with stability study data of the firm (if any) hence no such inspection has been conducted.
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of Drug Manufacturing
manufacturer issued by concerned regulatory License of Hebei Guolong Pharmaceutical Co. Ltd.
authority of country of origin. (No. JI20150058) issued by Hebei Provincial Drug
Administration dated 22-07-2020. The certificate is
approval from DRAP (in case of import). specifying purchase of 10Kg Azithromycin
dihydrate cleared dated 24-08-2021. The invoice is
cleared by AD (I&E).
attested respective documents like all batches along with UV spectra, raw data sheets,
chromatograms, Raw data sheets, COA, summary COA and summary data sheets.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not applicable. Our HPLC systems are not 21
audit trail reports on product testing CFR compliant
Evaluation by PEC:

1. Submit data in section 3.2.S.4.1 as per the Firm has submitted drug substance specifications and
guidance document approved by Registration analytical method from both API manufacturer as well as
Board which specifies that “Copies of the Nagarsons Pharma.
2. Submit verification studies of the analytical Firm has submitted report of verification studies of the
method of drug substance in section 3.2.S.4.3. analytical method of drug substance.
3. Provide COA of relevant batch of drug Firm has submitted COA of relevant batch of drug
substance which is used in the manufacturing substance from API manufacturer as well as Nagarsons
of batches of drug product. Pharma.
4. Submit stability study data in proper sequence Firm has submitted complete data in section 3.2.P.8.3 as
as per the guidelines of registration Board per the guidelines specified in CTD guidance document.
since the submitted data is not properly
aligned.
5. Provide raw data sheets for the calculation of Firm has submitted raw data sheets for the calculation of
results of dissolution test throughout the results of dissolution test throughout the stability studies
stability studies. using HPLC method.
6. Provide evidence of column oven which is Firm has not submitted evidence of HPLC along with
required to maintain temperature of 50° column oven.
7. Submit Batch Manufacturing Record of three Firm has submitted copy of Batch Manufacturing Record
stability batches. of three stability batches.
Deferred for submission of evidence of HPLC system along with column oven which is required to maintain
temperature of 50° for assay testing of drug product as per USP monograph.
 Copy of invoice from Prestigious Multi Enterprises for purchase of HPLC dated 12-01-2021.
 Firm has also submitted another copy of invoice from Prestigious Multi Enterprises dated 12-01-
2021 for purchase of HPLC column c-18 along with HPLC Column Oven.
 Firm has also submitted caliberation certificate from Galvano Scientific (Pvt) Ltd dated 12-04-2022
for caliberation of HPLC including its column oven set at 40 degree.
 Picture of an HPLC system with column oven set at 50 degree claimed to be placed in their QC lab.
Decision: Approved.
 Firm shall submit IQ, OQ and PQ of HPLC system along with column oven before issuance
of registration letter.
Rawat, Rawalpindi
☐ Importer
Firm has submitted copy of contract manufacturing
agreement with applicant firm dated 25-03-2021.
Evidence of approval of manufacturing Firm has submitted copy of section approval letter
facility dated 14-02-2020 which specifies Dry Vial section
(Cephalosporin).
☐ Export sale
The proposed proprietary name / brand name ROVITROX 2g Injection IV
Pharmaceutical form of applied drug Sterile white to off white / yellowish crystalline
powder filled in transparent glass vials
For generic drugs (me-too status) Rocephin injection by Roche.
Name and address of API manufacturer. Pharmagen Ltd. Kot Nabi Buksh Wala 34-Km,
drug product.
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.
Firm has also submitted compatibility studies of the
drug product along with the recommended diluent i.e.
water for injection.
Comparative Dissolution Profile equivalence for all the quality tests defined in USP
for their product against the comparator i.e. Rocephin
2g Injection of M/s Roche Pakistan.
Analytical method validation/verification of Firm has submitted report of verification of analytical
product method for the drug substance.
Firm has submitted report of verification of analytical
method for the drug product.
Manufacturer of API Pharmagen Ltd. Kot Nabi Buksh Wala 34-Km, Ferozepur Road, Lahore.
API Lot No. 00421/002/2019
Description of Pack
Glass vials
Batch No. 001 002 003
No. of Batches 03
1. Reference of previous approval of applications Biogen Pharmaceutical is a new License facility hence
with stability study data of the firm (if any) no such inspection has been conducted
2. Approval of API/ DML/GMP certificate of API Firm has submitted copy of GMP certificate issued by
manufacturer issued by concerned regulatory Additional Director DRAP, Lahore dated 11-01-2019.
authority of country of origin. The GMP certificate was granted based on inspection
dated 08-01-2019.
(sterile) dated 19-02-2020.
5. Compliance Record of HPLC software 21CFR Firm has submitted that their HPLC system is not 21
& audit trail reports on product testing CFR compliant.
Evaluation by PEC:
Firm was asked to submit the following:
drug product manufacturer as per the decision of 312nd meeting of Registration Board, since the
submitted data are of trial batches.
The firm submitted its response (Dy No. 6979) dated 14-03-2022 submitted the following data:
and Technological Development Zone, Datong Shanxi. China.
Description of Pack
Glass vials
Batch No. 21H043 21H044 21H045
Batch Size 10,000 vials 10,000 vials 10,000 vials
No. of Batches 03
1. Reference of previous approval of applications Biogen Pharmaceutical is a new License facility hence
with stability study data of the firm (if any) no such inspection has been conducted
Ceftriaxone sodium (sterile). The invoice was cleared
by AD (I&E).
5. Compliance Record of HPLC software 21CFR Firm has submitted that their HPLC system is not 21
& audit trail reports on product testing CFR compliant.
Evaluation by PEC:
 Firm has changed the source of drug substance from Pharmagen limited to Sinopharm Weiqida.
 Firm has submitted copy of BMR of commercial batches.
 Firm has not submitted fee for change of API source and stability study data.
Deferred for clarification for performing pharmaceutical equivalence studies against Rocephin Injection 2g
since this product is not registered in Pakistan.
Firm has submitted as under:
Please refer to the subject cited above; we are hereby submitting the Pharmaceuticals equivalence of
Rovitrox 2g Injection with Oxidil 2g Injection. Typographically mistake in Pharmaceutical equivalence
Report mentioned Rocipen 2g injection instead of oxidil 2gm injection.
Firm has submitted pharmaceutical equivalence report against Oxidil 2g Injection manufactured by Sami
with following product details
Batch No: 010E
Mfg. Date: 09-2019
Exp. Date: 08-2021
Decision: Approved.
Name, address of Manufacturing site. M/s Biogen Pharmaceuticals 8Km, Chakbeli Road
Rawat, Rawalpindi
☐ Importer
dated 14-02-2020 which specifies Capsule section
(Cephalosporin).
☐ Export sale
The proposed proprietary name / brand name VALIXIME 200mg/5ml Dry Suspension
Pharmaceutical form of applied drug White to off white powder filled in glass bottle
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
product against Cefspan suspension.
API Lot No. 00243/050/2020
Description of Pack
Glass bottle
Batch No. 001 002 003
No. of Batches 03
Cefixime (Micronized).
data sheets etc.
Evaluation by PEC:
Firm was issued letter of shortcoming for the following observations. The firm has replied to the queries and
the response is as below:

Submit differential fee for the registration of applied Firm has submitted that they will submit the differential
product, since the notification for revision of fee vide fee before issuance of registration letter.
SRO No. F.7-11/2012-B&A/DRA was published on 7th
Submit valid contract manufacturing agreement between Firm has submitted contract manufacturing agreement
the contract giver and contract acceptor. dated 17th December 2020 between the contract giver and
contract acceptor.
Submit product development and stability study data of Firm has submitted stability study data of 3 commercial
commercial batches manufactured by the drug product batches and have referred to the product development
manufacturer, since the submitted data are of trial studies previously submitted in the initial application.
batches. The details of the stability studies data is as follows:
STABILITY STUDY DATA OF COMMERCIAL BATCHES
API Lot No. 00243/050/2020
Description of Pack
Glass bottle
Batch No. 21D002 21D004 21E002
No. of Batches 03
3. Documents for the procurement of API with Not submitted.
approval from DRAP (in case of import).
data sheets etc.
5. Compliance Record of HPLC software 21CFR & HPLC system is not 21 CFR compliant
th
Decision of 316 meeting of Registration Board:
Deferred for submission of documents for procurement of drug substance which is used in the manufacturing
of commercial batches of the drug product.
Submission by the firm: Firm has submitted copy of invoice dated 30-06-2021 from Pharmagen Limited
specifying purchase of Cefixime (micronized) 25kg.
Decision: Approved.
 Firm shall submit full fee 75,000/- for revision of stability study data as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
744. Name, address of Applicant / Marketing M/s Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
Authorization Holder North Western Industrial Zone, Bin Qasim, Karachi-
75020, Pakistan.
Name, address of Manufacturing site. M/s Kaizen Pharmaceuticals (Pvt.) Ltd., E-127-129,
North Western Industrial Zone, Bin Qasim, Karachi-
75020, Pakistan.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy. No. 16356 Dated 14-06-2021
Details of fee submitted PKR 20,000/-: Dated 17-11-2020
GMP status of the Finished product GMP inspection report dated 11-08-2020 concluded
manufacturer that overall GMP compliance of the firm with
respect to building, facilities and procedures
demonstrated was satisfactory at the time of
inspection.
The proposed proprietary name / brand name Rebamide 100mg tablet
Strength / concentration of drug of Active Each film coated tablet contains
Pharmaceutical ingredient (API) per unit Rebamipide…………….100mg
Pharmaceutical form of applied drug White round biconvex tablet coated plain on both
sides.
Pharmacotherapeutic Group of (API) Gastro-protective drug
Reference to Finished product specifications JP specifications
Proposed Pack size 10’s, 20’s, 30’s
The status in reference regulatory authorities Mucosta Tablets 100mg of M/s Otsuka
Pharmaceutical Co., Ltd (PMDA approved)
For generic drugs (me-too status) Mucosta 100mg tablet by Otsuka (Reg # 078129)
Name and address of API manufacturer. M/s Jiangxi synergy pharmaceutical, Co., Ltd
Jiangxi fengxin Industrial part, fengxin, Jiangxi
province, P.R. China
template. Summarized information related to
nomenclature, structure, general properties,
its verification, batch analysis and justification of
drug product is submitted.
Module III (Drug Substance) Official monograph of Rebamipide is present in JP.
The firm has submitted details of nomenclature,
structure, general properties, solubilities, physical
form, manufacturers, description of manufacturing
process and controls, specifications, analytical
procedures and its verification, batch analysis and
substance
Real time: 30°C ±2°C /65% ±5%RH for 60 months
Accelerated: 40°C ±2°C / 75% ±5%RH for 6 months
Batches: (20100704, 20100705, 20100706)
Module-III (Drug Product): The firm has submitted data of drug product
including its description, composition,
manufacturing process and process control, process
validation protocols and report, control of
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence have been established
dissolution profile against innovator product Mucosta 100mg tablet
(batch # 7B79MT3) by Otsuka Pharmaceutical Co.,
Ltd by performing quality tests (Physical
appearance, thickness, hardness, disintegration,
Dissolution, Assay).
CDP has been performed with Mucosta 100mg
Tablet by otsuka Pharma in acidic media (pH 0.1N
HCl) & Phosphate Buffer (pH 6.8, 4.5, 6.0). The
values for f1 and f2 are in the acceptable range.
Analytical method validation/verification of Method verification studies have submitted
product including linearity, accuracy, precision, LOD, LOQ)
Manufacturer of API M/s Jiangxi synergy pharmaceutical, Co., Ltd,
Jiangxi fengxin industrial part, fengxin, Jiangxi province, P.R.China
API Lot No. 05-20170201C
Description of Pack
Alu / PVC Blister pack (10’s, 20’s, 30’s)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. TF-01 TF-02 TF-03
No. of Batches 03
1. Reference of previous approval of The firm has submitted reference of previous
applications with stability study data of the inspection report of Rofair 500 mcg Tablet which is
firm (if any) conducted on 25-06-2019. The report confirms that:
HPLC system is 21 CFR part II compliant.
Digital data logger was present.
2. Approval of API/ DML/GMP certificate of The firm has submitted copy of DML No. GAN
API manufacturer issued by concerned 20160125 issued by Jiangxi province FDA valid till
regulatory authority of country of origin. 15-02-2021.
The firm has submitted copy of GMP certificate (No.
2017001) issued by Jiangxi CCD valid till 23-07-
2022.
3. Documents for the procurement of API with The firm has submitted copy of Form 6 license no.
approval from DRAP (in case of import). 2782 cleared by AD (I & E) DRAP, dated 12-10-
2017. However, invoice is not attested.
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software The firm has submitted compliance Record of HPLC
21CFR & audit trail reports on product testing software 21CFR & Audit trail on testing reports of
product submitted.
and humidity monitoring of stability temperature and humidity monitoring of real time
chambers (real time and accelerated). and accelerated stability chambers.
Sr. Observations communicated Response by the firm
No.
1. Copies of the Drug substance specifications The firm has submitted copies of drug substance
and analytical procedures used for routine specifications and analytical procedures from both
testing of the drug substance / active drug substance manufacturer and drug product
pharmaceutical ingredient by both drug manufacturer.
substance & drug Product manufacturer.
2. Analytical method verification reports of The firm has submitted analytical method
parameters like specificity, accuracy and verification report of Rebamipide by titration
repeatability (method precision) performed by method.
the Drug Product manufacturer for both
compendial as well as non-compendial drug
substance(s) shall be submitted.
3. COA of primary / secondary reference The firm has submitted copy of CoA of working
standard including source and lot number standard of Rebamipide (lot # 201639).
shall be provided.
4. List of all components of the dosage form, and The firm has submitted qualitative and quantitative
their amount on a per unit basis, the function composition alongwith function of components and
of the components, and a reference to their reference to their quality standards.
quality standards (e.g. compendial
monographs or manufacturer’s specifications)
shall be submitted.
5. Details of batch numbers of reference product Details of pack of innovator product Mucosta
and test formulation used for Pharmaceutical Tablet 100mg (Batch # 7B79MT3) of M/s Otsuka
equivalence are required. pharmaceutical Co., Ltd have been submitted.
6. The results of analytical method verification The firm has provided summarized tabulated results
studies need to be summarized in tabulated for linearity, accuracy, precision and specificity.
form for each parameter since only
chromatograms are presented for each
parameter.
7. The copies of complete analysis of at least two Batch analysis of two batches of Rebamipide tablet
batches shall be provided. 100mg were provided.
8. Those impurities that are degradation product Details of related substances were included in
shall be included in the specifications. finished product specifications.
9. Justification of specification of non- Since the monograph of Rebamipide Tablet 100mg
pharmacopeial product shall be based on is available in Japanese pharmacopoeia. Therefore,
batch analysis results. no justification of specifications is required.
10. Description of the primary container closure The firm has provided specifications of PVC film
systems shall be submitted. clear transparent and Aluminium Foil Blister.
11. The results of stability data of B. No.: 002 The firm has submitted 6-month accelerated and
(TF-02) are lying borderline limit of 95% at 24-month real time stability study data of applied
18 months. Result of 24-month stability time product. The assay result of 24-month time point is
point is not submitted.
95.09% for B. No. 002 which is lying at borderline
limit of 95% -105%.
12. Submitted chromatograms do not reflect the Details of UVProbe software containing
UV detector wavelength at which analysis has wavelength of 326 nm have been provided.
been conducted.
13. The submitted copy of DML is expired and The firm has submitted copy of GMP certificate of
submitted copy of GMP certificate is not M/s Jiangxi Synergy Pharmaceutical Co., Ltd,
issued by concerned regulatory authority of china issued by Jiangxi Food and Drug
country of origin. Administration. The certificate is valid till 23-07-
2022.
approval from DRAP including commercial import of Rebamipide JP17 (260g) dated 18-07-
invoice. 2017 received through DHL courier. The invoice is
not cleared by AD (I&E) of field office.
Previous Decision: Deferred for submission of any document confirming that material (Rebamipide (260g))
has been imported and cleared by Custom authorities against the submitted invoice.
Evaluation by PEC: The firm has submitted copies of Form-6 and invoice for the purchase of Rebamipide
JP (Quantity: 260mg, invoice no. JXSS170718) from M/s Jiangxi Fengxin pharmaceutical Co. Ltd., China
attested by Assistant Director (I&E) DRAP, Karachi dated 17-10-2017.
Registration Board decided to defer the case and referred both invoices to DRAP Karachi for verification from
record since 1st submitted invoice was without attestation/clearance from DRAP Karachi.
Evaluation by PEC:
The case along with copy of invoice, Form 6 and Decision of 317th meeting of Registration Board was
forwarded to Additional Director DRAP Karachi office through e-office file number “copy-of-31/2022-PEC-
002” by Incharge PEC on 18-08-2022. The status of the invoice has been verified with following remarks:
“Respected Sir,
with refer to Para- 2/N Form-6 and invoice has been checked from available office records and it is verified
that the same has been issued from this office further the copies are also attached for ready reference, please”
The case is submitted for consideration by the Board.
Decision: Approved.
745. Name, address of Applicant / M/s Wilson’s Pharmaceuticals. Plot No. 387-388,
Marketing Authorization Holder Sector I-9, Industrial Area, Islamabad.
Name, address of Manufacturing site. M/s Wilson’s Pharmaceuticals. Plot No. 387-388, Sector
I-9, Industrial Area, Islamabad.
☐ Importer
GMP status of the firm Inspection report dated 24-01-2018 concludes very good
level of cGMP compliance.
Evidence of approval of manufacturing Firm has submitted copy of Section approval letter dated
facility 27-07-2015 specifying Tablet General section.
☐ Export sale
Proposed proprietary name / brand name CONOFEN Tablet 10/200mg
Pharmaceutical ingredient (API) per unit Phenylephrine HCl……10mg
Ibuprofen……..200mg
Pharmaceutical form of applied drug Light brown colored film coated tablet, oval (Biconvex)
with bisect line on one side and plain on other side
Pharmacotherapeutic Group of (API) NSAID in combination with sympathomimetic amine
Reference to Finished product Manufacturer’s specs
specifications
Proposed Pack size 10’s, 20’s, 30’s, 100’s
The status in reference regulatory Advil Congestion Relief Tablet 200mg/10mg (USFDA
authorities Approved)
Name and address of API manufacturer. Phenylephrine HCl: Shenzhen oriental pharmaceutical
Co. Ltd. #43, Dakeng Road, Tongle Village, Longgang
District Shenzhen China.
Ibuprofen: Zenith Chemical Industries (Pvt) Limited.
MozaDhonday, JiaBaga Raiwind-Kahna Road, Raiwind
Pakistan.
Firm has summarized information related to
drug substance.
drug substance.
Firm has submitted DMF for both drug substances
including their stability study data.
Stability Studies of Drug Substance Firm has submitted stability study data of 3 batches of
(Conditions & duration of Stability both API at accelerated and real time conditions. The real
studies) time stability data is conducted as per zone IV-A
conditions.
procedures, validation of analytical procedures, batch
analysis, justification of specifications, reference
standard or materials, container closure system and
stability.
Pharmaceutical Equivalence and Firm has not submitted data of pharmaceutical
Comparative Dissolution Profile equivalence as well as comparative dissolution profile
Analytical method validation/verification Firm has submitted report of validation of analytical
of product method for the drug product.
Firm has submitted report of verification studies of
analytical method for the drug substance.
Manufacturer of API Phenylephrine HCl: Shenzhen oriental pharmaceutical Co. Ltd. #43,
Dakeng Road, Tongle Village, Longgang District Shenzhen China.
Ibuprofen: Zenith Chemical Industries (Pvt) Limited. MozaDhonday,
JiaBaga Raiwind-Kahna Road, Raiwind Pakistan.
API Lot No. Phenylephrine HCl: PEH-180101Y1
Ibuprofen: ZIBU18-009
Description of Pack
Alu-Alu Blister
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months)
Batch No. Trial-01 Trial-02 Trial-03
Batch Size 1500 tablet 1500 tablet 1500 tablet
No. of Batches 03
1. Reference of previous approval of Firm has referred to their last inspection report for their
applications with stability study data of the product “saferon tablet ”
firm (if any) Registration Board in its 278th meeting decided to approve
Registration of “Saferon (Sofosbuvir 400mg) tablets by
M/s Wilson Pharmaceuticals, I-9 Industrial Area,
Islamabad.
Date of Inspection: 10-12-2015 , 19-04-2017 & 20-01-
2018
 Software of HPLC present in the firm is 21CFR
compliant and audit trail on the testing reports was
available and confirmed.
2. Approval of API/ DML/GMP certificate Phenylephrine HCl: Copy of GMP certificate (No.
of API manufacturer issued by concerned GD20150448) issued by CFDA china is submitted by the
regulatory authority of country of origin. firm. The certificate is valid till 07-12-2020.
Ibuprofen: Copy of GMP certificate of M/s Zenith
Chemical Industries (Pvt) Limited dated 22-05-2019
issued on the basis of inspection dated 06-12-2018 is
submitted by the firm. The certificate is issued by
Additional Director DRAP Lahore.
3. Documents for the procurement of API Phenylephrine HCl: Firm has submitted copy of
with approval from DRAP (in case of commercial invoice specifying import of 308.25g of
import). phenylephrine dated 10-05-2018. The invoice is signed by
AD (I&E) DRAP Islamabad.
Ibuprofen: Firm has submitted copy of invoice
specifying purchase of 250Kg Ibuprofen from Zenith
Chemical Industries Lahore dated 26-06-2018.
4. Data of stability batches will be supported Firm has submitted complete record of testing of all
by attested respective documents like batches along with chromatograms, raw data sheets, COA
chromatograms, Raw data sheets, COA, and summary data sheets.
5. Compliance Record of HPLC software Firm has submitted audit trail record of product testing of
21CFR & audit trail reports on product HPLC for all test intervals.
testing
accelerated)
Evaluation by PEC3:
Submit data of pharmaceutical equivalence in Pharmaceutical equivalence dissolution study has
section 3.2.P.2.2.1. to comply the decision of 293rd not been performed due to non-availability of
meeting of Registration Board, which states that reference product in local market (Pakistan) and it
“Pharmaceutical equivalence of the applied drug is difficult to arrange. However, we are committed
shall be established with the innovator / reference / to conduct / perform pharmaceutical equivalence of
comparator product and results of all the quality reference product as available and will submit the
tests (mentioned in any official pharmacopoeia or requisite data.
section 3.2.P.5.1 of this application) of the
developed formulation & the innovator / reference
/ comparator product should be submitted and
discussed.”
Submit summary of the results of comparative Comparative dissolution study has not been
dissolution profile in section 3.2.P.2.2.1. to comply performed due to non-availability of reference
the decision of 293rd meeting of Registration Board, product in local market (Pakistan) and it is difficult
which states that “The results of comparative to arrange. However, we are committed to conduct
dissolution profile conducted in three BCS media / perform pharmaceutical equivalence of reference
across the physiological pH range along with product as available and will submit the requisite
calculation of similarity factor f2 should be data.
submitted and discussed. For comparative
dissolution profile, the guidelines specified in WHO
Technical Report Series No. 992, 2015, Annex 7,
Appendix 1 Recommendations for conducting and
assessing comparative dissolution profiles and
USFDA Guidance for Industry Dissolution Testing
of Immediate Release Solid Oral Dosage Forms -
Dissolution Profile Comparisons may be followed”.
Scientific rationale for development of tablet Our applied Drug products (Conofen Tablets
having bisect line on one side of the tablet. 5/200mg and Conofen Tablets 10/200mg)
compressed on oval (bi-convex) shaped having
bisect line on one side and plain on other side which
is our available punch design and the applied drug
products are stable with afore mentioned punch
design. Moreover, we had submitted the stability
studies data of three batches (Trials) on accelerated
and real-Time stability conditions (as per decision
of 293rd meeting of Drug Registration Board.
Provide acceptance criteria in terms of the amount Acceptance criteria in terms of the amount of
of dissolved active ingredient “Q” for dissolution dissolved active ingredient Q = NLT 80% for
test at 15 minutes. dissolution test of conofen tablets at 15minutes for
both Phenylephrine HCL and Ibuprofen.
Deferred for following submissions:
 Pharmaceutical equivalence data of the applied product along with innovator / reference or
comparator product.
 Comparative Dissolution Profile (CDP) data of the applied product along with innovator / reference
or comparator product.
Reason for deferment Response by the firm
Pharmaceutical equivalence data of the Firm has submitted results of pharmaceutical equivalence of their
applied product along with innovator / product against the reference product Advil Tablet.
reference or comparator product. Manufacturer: Pfizer Madison NJ USA
Batch No: R86956
Exp Date: 06/2023
Comparative Dissolution Profile (CDP) data Firm has submitted results of Comparative Dissolution Profile
of the applied product along with innovator / (CDP) of their product against the reference product Advil Tablet in
reference or comparator product. three dissolution medium as recommended by WHO guidelines.
Manufacturer: Pfizer Madison NJ USA
Batch No: R86956
Exp Date: 06/2023
Decision of 313rd meeting of Registration Board:
 Updated GMP status of the firm from QA&LT Division DRAP.
 Submission of fee for revision of specifications of the drug product.
1. Updated GMP status of the firm from QA&LT Firm has submitted copy of GMP certificate issued on
Division DRAP. the basis of inspection dated 28-07-2022.
2. Submission of fee for revision of specifications Firm has submitted copy of fee challan (Number:
of the drug product. 77974410916) for change in specifications for amount
7,500/- dated 22-08-2022.
746. Name, address of Applicant / Marketing M/s World Biz Pharmaceutical Company, Plot No. 340,
Authorization Holder Multan Industrial Estate, Multan.
Name, address of Manufacturing site. M/s World Biz Pharmaceutical Company, Plot No. 340,
Multan Industrial Estate, Multan.
☐ Importer
GMP status of the firm Firm has submitted copy of DML number 000942 issued
on 13-09-2021.
Evidence of approval of manufacturing Firm has submitted copy of letter of issuance of DML
facility dated 17-09-2021 specifying Oral liquid syrup section
(General).
☐ Export sale
The proposed proprietary name / brand Para Biz Suspension 120mg/5ml
name
Strength / concentration of drug of Each 5ml contains:
Active Pharmaceutical ingredient (API) Paracetamol ………120mg
per unit
Pharmaceutical form of applied drug Oral suspension
Pharmacotherapeutic Group of (API) Analgesic / antipyretic
Reference to Finished product BP
specifications
The status in reference regulatory Junior Paracetamol Suspension (MHRA Approved)
authorities
For generic drugs (me-too status) Calpol suspension of M/s GSK Pakistan (Reg # 000354)
Name and address of API manufacturer. M/s Zenith Chemical Industries (Pvt) Limited. 16
Kilometer off Ferozepur-Road, Behind Wapda Grid
station,1 kilometer of Chandrai Road Lahore - Pakistan
drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for both drug substance
data related to nomenclature, structure, general properties,
drug substance.
(Conditions & duration of Stability drug substance at both accelerated as well as real time
studies) conditions. The accelerated stability data is conducted at
40oC ± 2oC / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30oC ± 2oC / 65% ± 5% RH
for 48 months.
Pharmaceutical Equivalence and Firm has submitted results of pharmaceutical equivalence
Comparative Dissolution Profile for all the quality tests defined in BP for their product
against the reference product i.e. PANADOL suspension
of GSK Pakistan (Pvt) Ltd.
Analytical method validation/verification Firm has submitted report of verification of analytical
of product method for the drug substance.
Manufacturer of API M/s Zenith Chemical Industries (Pvt) Limited. 16 Kilometer off Ferozepur-
Road, Behind Wapda Grid station,1 kilometer of Chandrai Road Lahore -
Pakistan
API Lot No. ZPAR20-350
Description of Pack
(Container closure Amber color glass bottle
system)
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Batch No. RD-AS-001 RD-AS-002 RD-AS-003
Batch Size 2000 Bottle 2000 Bottle 2000 Bottle
No. of Batches 03
1. Reference of previous approval of Not submitted
firm (if any)
2. Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate of M/s Zenith
API manufacturer issued by concerned Chemical Industries is issued by DRAP on 22-05-2019.
regulatory authority of country of origin. The certificate is issued based on the inspection dated 06-
12-2018.
3. Documents for the procurement of API Not submitted
with approval from DRAP (in case of
import).
4. Data of stability batches will be supported Firm has submitted complete record of testing of all
by attested respective documents like batches along with UV spectra, raw data sheets, COA and
5. Compliance Record of HPLC software Not applicable. Our HPLC systems are not 21
21CFR & audit trail reports on product CFR compliant
testing
accelerated)
Evaluation by PEC:
 Submit data in section 3.2.S.4.1 as per the guidance document approved by Registration Board which
specifies that “Copies of the Drug substance specifications and analytical procedures used for routine
testing of the Drug substance /Active Pharmaceutical Ingredient by both Drug substance & Drug
 Provide verification studies of drug substance from drug product manufacturer.
 Specifications are mentioned as BP in some sections and USP in other sections.
 Assay method is based on HPLC while verification studies are conducted on UV method.
 Analytical method specifies HPLC method, while assay testing in stability studies is conducted on
UV
 Provide copy of commercial invoice for evidence of purchase of the drug substance.
Deferred for;
 Submission of data in section 3.2.S.4.1 as per the guidance document approved by Registration
Board which specifies that “Copies of the Drug substance specifications and analytical procedures
used for routine testing of the Drug substance /Active Pharmaceutical Ingredient by both Drug
substance & Drug Product manufacturer is required.”
 Submission of verification studies of drug substance from drug product manufacturer.
 Clarification since specifications are mentioned as BP in some sections and USP in other sections.
 Clarification regarding the assay method which is based on HPLC while verification studies are
conducted on UV method.
 Clarification since analytical method specifies HPLC method, while assay testing in stability studies
is conducted on UV
 Submission of copy of commercial invoice for evidence of purchase of the drug substance.
1. Submission of data in section 3.2.S.4.1 as per Firm has submitted copy of specifications of the drug
the guidance document approved by substance from drug product manufacturer as well.
Registration Board which specifies that
“Copies of the Drug substance specifications
and analytical procedures used for routine
testing of the Drug substance /Active
Pharmaceutical Ingredient by both Drug
substance & Drug Product manufacturer is
required.”
2. Submission of verification studies of drug Firm has submitted report of verification studies of the
substance from drug product manufacturer. analytical method of drug substance performed by drug
product manufacturer.
3. Clarification since specifications are Applied product is of BP specifications.
mentioned as BP in some sections and USP in
other sections.
4. Clarification regarding the assay method which We have adopted alternate method in which assay is
is based on HPLC while verification studies are based on UV method for stability of batches for CTD
conducted on UV method. purpose. After registration we will adopt
pharmacopoeia method and will verify it as per ICH
guidelines.
5. Clarification since analytical method specifies We have adopted alternate method in which assay is
HPLC method, while assay testing in stability based on UV method for stability of batches for CTD
studies is conducted on UV purpose. After registration as per undertaking we will
adopt pharmacopoeial method for process validation
and both accelerated and long term stability studies of
commercial batches.
6. Submission of copy of commercial invoice for Firm has submitted copy of commercial invoice dated
evidence of purchase of the drug substance. 29-10-2021 specifying purchase of 10Kg paracetamol.
Decision of 321st meeting of Registration Board:
The Board discussed that the official monograph of the applied product is present in B.P whereas the firm
has performed the testing according to In-House specifications. The Board decided to defer the case for
submission of testing of the applied product according the monograph available in B.P along with the
analytical method verification studies for the drug product on the next month time point of long term stability
studies for all the 03 stability batches.
 Copy of method verification studies of the applied product according to BP monograph.
 9 months stability study data at real time conditions for three batches conducted as per BP
monograph along with analytical record.
747. Name, address of Applicant / Marketing M/s Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25
Authorization Holder Sector 20, Korangi Industrial Area Karachi.
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals (Pvt) Ltd. 581,
Sundar Industrial Estate, Raiwind Road Lahore.
☐ Importer
GMP status of the firm Stallion Pharmaceuticals: Firm has submitted
GMP certificate issued on the basis of inspection
dated 22-09-2020.
000783 of M/s Stallion Pharma Islamabad dated
08-02-2016 specifying dry powder injection Vial
(carbapenem) section.
☐ Export sale
The proposed proprietary name / brand name ASPINEM 500mg Injection
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……500mg
(blended with sodium carbonate)
Pharmaceutical form of applied drug White or almost white, hygroscopic, crystalline,
powder filled in clear glass vials
For generic drugs (me-too status) Merrem Injection of Global Pharmaceuticals
Name and address of API manufacturer. M/s Aurobindo Pharma Limited Unit-V, Plot No.
68-70, 73-91, 95, 96, 260, 261 I.D.A Chemical
Zone, Pashamylaram, Patancheru Mandal, Sanga
Reddy District Telangana, India.
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
against Meronem 500mg Injection of Pfizer
Pakistan Ltd.
Manufacturer of API M/s Aurobindo Pharma Limited Unit-V, Plot No. 68-70, 73-91, 95, 96, 260,
261 I.D.A Chemical Zone, Pashamylaram, Patancheru Mandal, Sanga
API Lot No. 1705205135
1705205096
1705203623
Description of Pack
Glass vial
Batch No. T7003 T7004 T7005
No. of Batches 03
1. Reference of previous approval of applications No response submitted by the firm
2. Approval of API/ DML/GMP certificate of API
Firm has submitted copy of GMP certificate (No.
manufacturer issued by concerned regulatory
3298/E1/2019) issued by Drugs Control
authority of country of origin. Administration, Government of Telangana dated
11-02-2020. The certificate is valid till 3 years from
the date of issue.
3. Documents for the procurement of API with Not submitted
4. Data of stability batches will be supported by Not submitted
attested respective documents like
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Not submitted
6. Record of Digital data logger for temperature and Not submitted
Evaluation by PEC:
 Firm has submitted fee 70,000 for the application of contract manufacturing

Submit data in section 3.2.S.4.1 as per the guidance Firm has submitted copy of analytical method of drug
document approved by Registration Board which substance from the drug product manufacturer. The
specifies that “Copies of the Drug substance analytical method is issued on 20-07-2021.
specifications and analytical procedures used for routine
testing of the Drug substance /Active Pharmaceutical
Ingredient by both Drug substance & Drug Product
Submit data in section 3.2.S.4.3 as per the decision of Firm has submitted report of verification studies of the
293rd meeting of Registration Board, which states that analytical method of drug substance. However, the
“Analytical Method Verification studies including verification studies were conducted on 21-01-2021 while
specificity, accuracy and repeatability (method the analytical method of drug substance was issued by
precision) performed by the Drug Product manufacturer the drug product manufacturer on 20-07-2021.
for both compendial as well as non-compendial drug
substance(s) shall be submitted”. Further justify how the
analysis of drug substance was conducted without
performing verification studies of the analytical method
of drug substance.
Submit data in section 3.2.S.4.4 as per the guidance Firm has submitted COA of the drug substance generated
document approved by Registration Board which by drug product manufacturer only, while the COA of
specifies that “Provide results of analysis of relevant drug substance manufacturer is not submitted.
batch(es) of Drug Substance performed by Drug Product
manufacturer used during product development and
stability studies, along with Certificate of Analysis
(CoA) of the same batch from Drug Substance / /Active
Pharmaceutical Ingredient manufacture. A discussion
and justification shall be provided for any incomplete
analyses of the drug substance / API by Drug Product
manufacturer (e.g. results not tested according to the
proposed specification)”.
Submit COA of reference standard / working standard Firm has submitted COA of working standard from drug
including source and lot number which is actually used substance manufacturer which has been standardized
in the testing of drug substance and drug product. against USP reference standard.
However drug product manufacturer is using working
standard of meropenem Batch No. SI/MPM/00060120
manufactured by M/s Sterile India.
Justify the master formulation containing 570mg of Firm has submitted calculation to justify the filled
meropenem trihydrate for manufacturing of 500mg weight. As per calculations submitted by the firm the
meropenem for injection, since the drug substance weight 570mg per vial is calculated on theoretical basis
contains meropenem blended with 15.10 to 16.50% w/w considering that the drug substance has 100% assay,
of sodium carbonate. while the actual dispensing is to be made on the basis of
actual % assay of the meropenem.
Justify the use of 5% overage in the formulation, since We hereby justify that in development stage we added
the justification submitted in this regard is not supported 5% extra meropenem sterile powder for injection in
by any guidelines. initial batches. After completion of stability study
degradation is no more than 2 – 3% within the limit assay
range is 90 – 120% so no more 5% meropenem sterile
powder for injection is added.
Submit results of compatibility studies in section Firm has submitted result of compatibility studies of the
3.2.P.2.6. drug product with WFI.
Justify how the time and temperature of sterilization Firm has submitted summary report of autoclave
cycle is directly selected without any protocols for its machine re qualification instead of providing
validation. justification.
Provide detailed method of sample stock solution Firm has not submitted complete method of analysis of
preparation instead of mentioning the general statement the drug product in which the method of sample solution
“Constitute a container of Meropenem for Injection with preparation is explained.
a volume of water, corresponding to the quantity of
solvent specified in the labelling”.
Justify why the formula for calculation of assay contents Firm has submitted that we are using potency of working
of meropenem is different than that mentioned in USP standard as percentage. USP taking the potency in
monograph. mg/mg which is converted into percentage by
multiplying this ratio with 100. Firm has submitted
calculation to justify that their formula is equivalent to
USP.
However, the USP formula used by the firm is different
from that specified in USP.
Analytical method verification studies have not been Firm has submitted verification studies of the analytical
conducted and evaluated in the light of USP general method dated 21-01-2021, while the analytical method of
chapters and ICH guidelines. the drug product was revised and updated on 12-07-2021.
Justify why the drug product specifications does not In Meropenem trihydrate injection label claim is as
contain the test for sodium contents as recommended by meropenem while trihydrate and sodium considered as
USP. impurity. We are verifying the meropenem by HPLC and
due to unavailability of the atomic absorption we were
verifying the sodium content by titration method.
Moreover, for verification purpose, we analysed sodium
content from PCSI and Citi Pharma with atomic
absorption. And now we have atomic absorption in our
facility and we have changed our SOP accordingly and
now we are conducting each and every analysis of
sodium content in our facility as per USP monograph.
Justify the test of accuracy in analytical method Firm has submitted that we had performed the accuracy
validation without specifying the concentrations of the by making a concentration of standard preparation and
solution which are analysed for accuracy. Further justify three concentrations. The concentrations used by the firm
the use of solutions having low, medium, and high for accuracy test is 0.16mg/ml, 0.20mg/ml and
concentration of sample without specifying their exact 0.24mg/ml.
concentration. Such words are not recommended by any As per the analytical method the standard solution
scientific guidelines. concentration is 0.11mg/ml and the concentration used
by the firm to study accuracy does not include the said
concentration.
Linearity and range have been studied from 70% to 120% Two different samples were prepared for linearity and
of the solution wherein the area under curve for 100% accuracy parameter of analytical method verification, for
solution was 4691449 while in accuracy studies in the linearity parameter from the first dilution 6 further
same method none of the solution (either low, medium second dilutions 70%, 80%, 90%, 100%, 110% and
or high concentration) achieved such area although the 120% were prepared while in accuracy 3 further second
concentration of the solution is expected to be the same. dilutions low, medium and high were prepared. Because
Justification is required in this regard. the weights of the sample are different in linearity and
accuracy parameters that’s why the area achieved is
different for both parameters.
In linearity studies the area under curve for 100% In linearity the sample solution preparation is different
solution was 4691449, while in stability studies the area from the sample preparation of finished product. In
under curve of the sample solution having exactly same linearity a concentration of standard taken to prepare first
concentration is reported to be 11769485. Justification is dilution then make second dilution by taking 7ml, 8ml,
required in this regard how such huge difference in area 9ml, 10ml, 11ml, 12ml from the first dilution, second
under the curve can exist in the analysis and how this dilution of 10ml is considered as 100% concentration
method can be considered reliable and verified. while in finished good the dilution contain 100mg of
sample that’s why area under curve for 100% solution is
different from the area of 100mg in finished product.
The analytical method verification studies have been In 2017, we had completed analytical method
conducted in January 2021 while the batches were verification by performing three parameters which are
manufactured in 2017. Justification is required in this linearity, system suitability and specificity while when
regard. we submit the CTD dossier we came to know the DRAP
requirement of accuracy and repeatability, then we had
complete the analytical method verification by
performing five parameters which are linearity, system
suitability, specificity accuracy and repeatability.
Justify the limit of sodium content in the in house In past we were doing sodium content analysis by
generated COA of drug substance, in which limit of titration method (due to unavailability of AAS) the result
sodium content is taken as 6.0% to 9.3% and the drug was 9.12% limit of sodium content is 6.0% - 9.3% while
substance was passed on the basis of results of 9.12%, the drug substance manufacturer specifies the sodium
while the drug substance manufacturer specifies the limit content as 6.65 to 7.20%. Now we are doing sodium
of sodium content as 6.56% to 7.20%. content with AAS according to USP.
As per the submitted results of sodium content in Firm has not submitted any justification
meropenem injection by CITI Pharma, the results of %
sodium content is 7.867%, while USP specifies the
acceptance criteria to be 80%–120% of the labeled
amount of sodium. Justify how your results complies
USP specifications keeping in view the labelled amount
of sodium in your product.
Justify the use of commercial lot of meropenem for The assay of meropenem trihydrate USP reference
injection as working standard since USP recommends standard lot# J0K434, is 87.3% meropenem. Similarly by
that reference standard should be pure meropenem comparing with reference standard we prepare our
trihydrate. meropenem trihydrate working standard in which
82.12% is meropenem present. Actually the material
used in USP Reference standard and the working
standard is the same as meropenem trihydrate because
the product label claim is meropenem, therefore we have
to calculate the assay against the purity of material as
meropenem which is 87.3% in USP Reference standard
and 82.12% in working standard.
Provide details that which lot number of drug substance Firm has not submitted details that which lot number of
has been used in manufacturing of each batch of drug drug substance has been used in manufacturing of each
product. Also provide documents confirming evidence of batch of drug product.
import of each lot of drug substance used in Further documents confirming import of these relevant
manufacturing of these batches of drug product. batches are also required.
Provide data of stability batches properly arranged and Firm has not yet submitted stability study data in proper
supported by respective documents including analytical sequence with COA for each time point, raw data sheets
report / COA, raw data sheet and respective and chromatograms. Raw data sheets are not submitted.
chromatograms separately for each time point, since the Further the calculation formula used for the calculation
submitted chromatograms and analytical reports are of assay result is also different from USP as well as the
without any proper sequence. method of sample and standard solution preparation.
Provide Reference of previous approval of applications No response submitted by the firm
Provide compliance Record of HPLC software 21CFR & No response submitted by the firm
Provide Record of Digital data logger for temperature No response submitted by the firm
and humidity monitoring of stability chambers (real time
and accelerated).
 Submission of differential fee as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Submission of COA of relevant batch of drug substance from drug substance manufacturer used in
the manufacturing of batches for which stability study data is submitted.
 Scientific justification for using commercial batch manufactured by M/s Sterile India as working
standard.
 Scientific justification for use of 5% overage in the formulation.
 Submission of complete protocols of process validation studies of the drug product.
 Submission of detailed method of analysis of the drug product with details of sample solution
preparation.
 Scientific justification for using calculation formula for assay testing which is different from that
 Revision of drug product specifications in the light of USP monograph and inclusion of test for
sodium content along with submission of fee of Rs. 7,500 for correction/pre-approval change/ in
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Registration Board.
1. Submission of differential fee as per Firm has submitted differential fee 5,000/- vide slip
notification No.F.7-11/2012-B&A/DRAP number 551237597908 dated 20-05-2022.
dated 13-07-2021.
2. Submission of COA of relevant batch of drug Firm has submitted COA of relevant batch of drug
substance from drug substance manufacturer substance generated by drug substance manufacturer.
used in the manufacturing of batches for which
stability study data is submitted.
3. Scientific justification for using commercial This firm has submitted that the assay of Meropenem
batch manufactured by M/s Sterile India as Trihydrate USP reference standard lot # J0k434 is
working standard. 87.3%. Therefore, we used sterile India material as
working Standard having potency 82.02% by using
standardization procedure with USP reference standard.
Material used for batch manufacturing is from
Aurobindo China and working standard prepared is of
Sterile India having Potency 82.02%
COA’s for Reference standard & working standard
along with standardization procedure is submitted by
the firm.
4. Scientific justification for use of 5% overage in Firm has submitted that an overage is used to cover
the formulation. losses during manufacturing. Initially we used extra 5%
of Meropenem to deliver our product with exact
quantity of API in injection, the idea behind was to
deliver exact quantity of the active substance. After that
our product was stable throughout its
shelf life so no need to add extra 5% overage.
In general, use of an overage of a drug substance to
compensate for degradation during manufacture or a
product's shelf life, or to extend shelf life, is
discouraged. Overages are nothing but the extra
quantity of material taken, which is lost during process
stage.ICH Q8 guide line, provide a structured way to
define product critical quality attributes. We are not
using any overage in the manufacturing of Meropenem
injection
5. Submission of complete protocols of process Firm has submitted general protocols for process
validation studies of the drug product. validation. Firm has not submitted specific protocols
for the process validation of applied product.
6. Submission of detailed method of analysis of Firm has submitted detailed method of analysis of the
the drug product with details of sample solution drug product, However in the submitted method,
preparation. sample solution preparation method is still not clear
in terms of exact volume of water used to
reconstitute the contents of vial and then how to
make further dilutions. Furthermore, the calculation
formula use weight of sample and standard while USP
recommends to use concentration of sample and
standard.
7. Scientific justification for using calculation Firm has submitted that they are using the potency of
formula for assay testing which is different working standard as percentage. USP taking the
from that specified in USP monograph. Potency into mg/mg which is covered into percentage
multiplying the ratio with 100 so there is no difference
between the USP formula & our standard operating
formula further more we have amended our SOP with
respect to the formula given in USP.
However, the newly used calculation formula use
weight of sample and standard while USP
standard. The new formula is also not exactly as per
USP monograph.
8. Revision of drug product specifications in the Firm has now added sodium content test in their
light of USP monograph and inclusion of test specifications. Firm has also submitted fee 7,500/- vide
for sodium content along with submission of fee slip number 212267176 dated 20-05-2022.
of Rs. 7,500 for correction/pre-approval However, no data regarding the sodium content
change/ in product specifications, as per testing during stability studies is provided.
dated 13-07-2021.
9. Scientific justification for the analytical method Firm has not justified the previous validation reports,
verification studies of the drug product which is instead the firm has submitted new report in which the
not performed as per ICH guidelines. analysis is carried out on July 2022. The new report was
performed in line with ICH recommendations.
10. Submission of stability study data of three Firm has submitted data in section 3.2.P.8.3. The
commercial batches in section 3.2.P.8.3 as per evaluation os submitted data is as under:
the 6-points checklist provided in Form 5-F
guidance document (PE&R/GL/AF/004)
approved by the Registration Board.
Reference of previous approval of Not applicable

firm (if any)
Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate
API manufacturer issued by concerned (No. 3298/E1/2019) issued by Drugs Control
regulatory authority of country of origin.Administration, Government of Telangana
dated 11-02-2020. The certificate is valid till 3
years from the date of issue.
Documents for the procurement of API with 1705205135, 1705205096:
approval from DRAP (in case of import). Firm has submitted copy of commercial invoice
cleared dated 19-10-2017 specifying import of
20Kg meropenem for lot number 1705205135,
1705205096. The invoice is cleared by AD
(I&E) DRAP.
1705203623:
Firm has submitted copy of commercial invoice
15Kg meropenem for lot number 1705203623.
The invoice is cleared by AD (I&E) DRAP.
Data of stability batches will be supported by Firm has submitted analytical record of
attested respective documents like product testing including HPLC chromatogram
chromatograms, Raw data sheets, COA, and raw data sheets
Compliance Record of HPLC software Not submitted
21CFR & audit trail reports on product testing
Record of Digital data logger for temperature Firm has submitted record of digital data
and humidity monitoring of stability chambers logger for stability chambers for accelerated
(real time and accelerated) and real time stability study.

 Clarification for use of 5% overage in sterile products and specifications of the manufactured
products in the light of approved specifications and pharmacopoeial monographs.
 Capacity assessment of manufacturing and testing facility of M/s Stallion Pharmaceuticals (Pvt) Ltd.
581, Sundar Industrial Estate, Raiwind Road Lahore.
 Submission of specific protocols for the process validation of applied product.
 Submission of preparation sample solution is required since it is not clear in terms of exact volume
of water used to reconstitute the contents of vial and then how to make further dilutions. Furthermore,
the calculation formula use weight of sample and standard while USP recommends to use
concentration of sample and standard.
 Clarification regarding use of formula which is different from the formula as recommended by USP
for calculation of assay.

1. Clarification for use of 5% overage in sterile An overage is used to cover losses during manufacturing.
products and specifications of the Initially we used extra 5% of Meropenem to deliver our
manufactured products in the light of product with exact quantity of API in injection, the idea
approved specifications and pharmacopoeial behind was to
monographs. deliver exact quantity of the active substance. After that
product's shelf life, or to extend shelf life, is discouraged.
Overages are nothing but the extra quantity of material
taken, which is lost during process stage.ICH Q8 guide
line, provide a structured way to define product critical
quality attributes. We are not using any overage in the
manufacturing of Meropenem injection
2. Capacity assessment of manufacturing and Capacity assessment report is not yet received.
testing facility of M/s Stallion
Pharmaceuticals (Pvt) Ltd. 581, Sundar
Industrial Estate, Raiwind Road Lahore.
3. Submission of specific protocols for the Firm has submitted process validation protocols
process validation of applied product.
4. Submission of preparation sample solution is Firm has submitted revised testing method and
required since it is not clear in terms of exact specifications dated 30-09-2022.
volume of water used to reconstitute the The revised method is again unclear about the sample
contents of vial and then how to make further solution preparation method since it is not clear in terms
dilutions. Furthermore, the calculation of exact volume of water used to reconstitute the contents
formula use weight of sample and standard of vial.
while USP recommends to use concentration
of sample and standard.
5. Clarification regarding use of formula which Firm has submitted revised testing method and
is different from the formula as specifications dated 30-09-2022.
recommended by USP for calculation of The formula used for calculation of assay of drug product
assay. is different from USP since USP recommends
concentration of sample and standard solution while the
firm is using weight of sample and standard solution.
Firm has again submitted another revised testing method
and specifications dated 23-11-2022 in which the testing
method is as per USP monograph along with test for
sodium contents.
Proceedings & Decision: Registration Board was apprised that the applied formulation has already
been approved in 312th meeting opf Registration Board for contract manufacturing from M/s Stallion
Pharmaceuticals Pvt Ltd. on basis of Form 5F (CTD) of M/s Healthtek (Pvt) Ltd., Karachi as
applicant, wherein following submission had also been made by the firm and above mentioned points
have been addressed and responded:
1. Evidence for purchase of atomic absorption spectrophotometer in the form of purchase order
dated 14-06-2021, deliver challan dated 19-06-2021 & invoice No. 06/3029 dated 18-06-2021.
2. Installation and operational qualification reports of atomic absorption spectrophotometer
3. Analysis report of Sodium Content in Mopen (Meropenem) Injection by M/s Stallion
Pharmaceuticals (Pvt) Ltd., 581- Sundar Industrial Estate, Lahore.
On basis of above cited reference Registration Board decided to approve instant application.
Registration Board further authorized its Chairman for issuance of registration letters upon
satisfactory capacity assessment of manufacturing and testing facility of M/s Stallion Pharmaceuticals
(Pvt) Ltd., 581- Sundar Industrial Estate, Lahore wherein panel shall also review the testing of drug
substance and drug product of applied formulation as per pharmacopoeial requirements.
748. Name, address of Applicant / Marketing M/s Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25
Authorization Holder Sector 20, Korangi Industrial Area Karachi.
Name, address of Manufacturing site. M/s Stallion Pharmaceuticals (Pvt) Ltd. 581,
Sundar Industrial Estate, Raiwind Road Lahore.
☐ Importer
GMP status of the firm Stallion Pharmaceuticals: Firm has submitted
GMP certificate issued on the basis of inspection
dated 22-09-2020.
000783 of M/s Stallion Pharma Islamabad dated
08-02-2016 specifying dry powder injection Vial
☐ Export sale
The proposed proprietary name / brand name ASPINEM 1g Injection
Pharmaceutical ingredient (API) per unit Meropenem (as trihydrate)……1g
Pharmaceutical form of applied drug White or almost white, hygroscopic, crystalline,
powder filled in clear glass vials
Name and address of API manufacturer. M/s Aurobindo Pharma Limited Unit-V, Plot No.
68-70, 73-91, 95, 96, 260, 261 I.D.A Chemical
Zone, Pashamylaram, Patancheru Mandal, Sanga
product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
against Meronem 1g Injection of Pfizer Pakistan
Ltd.
Manufacturer of API M/s Aurobindo Pharma Limited Unit-V, Plot No. 68-70, 73-91, 95, 96, 260,
261 I.D.A Chemical Zone, Pashamylaram, Patancheru Mandal, Sanga
API Lot No. 1705205135
1705205096
1705203623
Description of Pack
Glass vial
Batch No. U7003 U7004 U7005
No. of Batches 03
1. Reference of previous approval of applications No response submitted by the firm
manufacturer issued by concerned regulatory 3298/E1/2019) issued by Drugs Control
authority of country of origin. Administration, Government of Telangana dated
11-02-2020. The certificate is valid till 3 years from
the date of issue.
data sheets etc.
Evaluation by PEC:
 Firm has submitted fee 70,000 for the application of contract manufacturing

Submit data in section 3.2.S.4.1 as per the guidance Firm has submitted copy of analytical method of drug
document approved by Registration Board which substance from the drug product manufacturer. The
specifies that “Copies of the Drug substance analytical method is issued on 20-07-2021.
specifications and analytical procedures used for routine
testing of the Drug substance /Active Pharmaceutical
Ingredient by both Drug substance & Drug Product
Submit data in section 3.2.S.4.3 as per the decision of Firm has submitted report of verification studies of the
293rd meeting of Registration Board, which states that analytical method of drug substance. However, the
“Analytical Method Verification studies including verification studies were conducted on 21-01-2021 while
specificity, accuracy and repeatability (method the analytical method of drug substance was issued by
precision) performed by the Drug Product manufacturer the drug product manufacturer on 20-07-2021.
for both compendial as well as non-compendial drug
substance(s) shall be submitted”. Further justify how the
analysis of drug substance was conducted without
performing verification studies of the analytical method
of drug substance.
Submit data in section 3.2.S.4.4 as per the guidance Firm has submitted COA of the drug substance generated
document approved by Registration Board which by drug product manufacturer only, while the COA of
specifies that “Provide results of analysis of relevant drug substance manufacturer is not submitted.
batch(es) of Drug Substance performed by Drug Product
manufacturer used during product development and
stability studies, along with Certificate of Analysis
(CoA) of the same batch from Drug Substance / /Active
Pharmaceutical Ingredient manufacture. A discussion
and justification shall be provided for any incomplete
analyses of the drug substance / API by Drug Product
manufacturer (e.g. results not tested according to the
proposed specification)”.
Submit COA of reference standard / working standard Firm has submitted COA of working standard from drug
including source and lot number which is actually used substance manufacturer which has been standardized
in the testing of drug substance and drug product. against USP reference standard.
However drug product manufacturer is using working
standard of meropenem Batch No. SI/MPM/00060120
manufactured by M/s Sterile India.
Justify the master formulation containing 1140mg of Firm has submitted calculation to justify the filled
meropenem trihydrate for manufacturing of 1g weight. As per calculations submitted by the firm the
meropenem for injection, since the drug substance weight 1140mg per vial is calculated on theoretical basis
contains meropenem blended with 15.10 to 16.50% w/w considering that the drug substance has 100% assay,
of sodium carbonate. while the actual dispensing is to be made on the basis of
actual % assay of the meropenem.
Justify the use of 5% overage in the formulation, since We hereby justify that in development stage we added
the justification submitted in this regard is not supported 5% extra meropenem sterile powder for injection in
by any guidelines. initial batches. After completion of stability study
degradation is no more than 2 – 3% within the limit assay
range is 90 – 120% so no more 5% meropenem sterile
powder for injection is added.
Submit results of compatibility studies in section Firm has submitted result of compatibility studies of the
3.2.P.2.6. drug product with WFI.
Justify how the time and temperature of sterilization Firm has submitted summary report of autoclave
cycle is directly selected without any protocols for its machine re qualification instead of providing
validation. justification.
Provide detailed method of sample stock solution Firm has not submitted complete method of analysis of
preparation instead of mentioning the general statement the drug product in which the method of sample solution
“Constitute a container of Meropenem for Injection with preparation is explained.
a volume of water, corresponding to the quantity of
solvent specified in the labelling”.
Justify why the formula for calculation of assay contents Firm has submitted that we are using potency of working
of meropenem is different than that mentioned in USP standard as percentage. USP taking the potency in
monograph. mg/mg which is converted into percentage by
multiplying this ratio with 100. Firm has submitted
calculation to justify that their formula is equivalent to
USP.
However, the USP formula used by the firm is different
from that specified in USP.
Analytical method verification studies have not been Firm has submitted verification studies of the analytical
conducted and evaluated in the light of USP general method dated 21-01-2021, while the analytical method of
chapters and ICH guidelines. the drug product was revised and updated on 12-07-2021.
Justify why the drug product specifications does not In Meropenem trihydrate injection label claim is as
contain the test for sodium contents as recommended by meropenem while trihydrate and sodium considered as
USP. impurity. We are verifying the meropenem by HPLC and
due to unavailability of the atomic absorption we were
verifying the sodium content by titration method.
Moreover, for verification purpose, we analysed sodium
content from PCSI and Citi Pharma with atomic
absorption. And now we have atomic absorption in our
facility and we have changed our SOP accordingly and
now we are conducting each and every analysis of
sodium content in our facility as per USP monograph.
Justify the test of accuracy in analytical method Firm has submitted that we had performed the accuracy
validation without specifying the concentrations of the by making a concentration of standard preparation and
solution which are analysed for accuracy. Further justify three concentrations. The concentrations used by the firm
the use of solutions having low, medium, and high for accuracy test is 0.16mg/ml, 0.20mg/ml and
concentration of sample without specifying their exact 0.24mg/ml.
concentration. Such words are not recommended by any As per the analytical method the standard solution
scientific guidelines. concentration is 0.11mg/ml and the concentration used
by the firm to study accuracy does not include the said
concentration.
Linearity and range have been studied from 70% to 120% Two different samples were prepared for linearity and
of the solution wherein the area under curve for 100% accuracy parameter of analytical method verification, for
solution was 4691449 while in accuracy studies in the linearity parameter from the first dilution 6 further
same method none of the solution (either low, medium second dilutions 70%, 80%, 90%, 100%, 110% and
or high concentration) achieved such area although the 120% were prepared while in accuracy 3 further second
concentration of the solution is expected to be the same. dilutions low, medium and high were prepared. Because
Justification is required in this regard. the weights of the sample are different in linearity and
accuracy parameters that’s why the area achieved is
different for both parameters.
In linearity studies the area under curve for 100% In linearity the sample solution preparation is different
solution was 4691449, while in stability studies the area from the sample preparation of finished product. In
under curve of the sample solution having exactly same linearity a concentration of standard taken to prepare first
concentration is reported to be 11769485. Justification is dilution then make second dilution by taking 7ml, 8ml,
required in this regard how such huge difference in area 9ml, 10ml, 11ml, 12ml from the first dilution, second
under the curve can exist in the analysis and how this dilution of 10ml is considered as 100% concentration
method can be considered reliable and verified. while in finished good the dilution contain 100mg of
sample that’s why area under curve for 100% solution is
different from the area of 100mg in finished product.
The analytical method verification studies have been In 2017, we had completed analytical method
conducted in January 2021 while the batches were verification by performing three parameters which are
manufactured in 2017. Justification is required in this linearity, system suitability and specificity while when
regard. we submit the CTD dossier we came to know the DRAP
requirement of accuracy and repeatability, then we had
complete the analytical method verification by
performing five parameters which are linearity, system
suitability, specificity accuracy and repeatability.
Justify the limit of sodium content in the in house In past we were doing sodium content analysis by
generated COA of drug substance, in which limit of titration method (due to unavailability of AAS) the result
sodium content is taken as 6.0% to 9.3% and the drug was 9.12% limit of sodium content is 6.0% - 9.3% while
substance was passed on the basis of results of 9.12%, the drug substance manufacturer specifies the sodium
while the drug substance manufacturer specifies the limit content as 6.65 to 7.20%. Now we are doing sodium
of sodium content as 6.56% to 7.20%. content with AAS according to USP.
As per the submitted results of sodium content in Firm has not submitted any justification
meropenem injection by CITI Pharma, the results of %
sodium content is 7.867%, while USP specifies the
acceptance criteria to be 80%–120% of the labeled
amount of sodium. Justify how your results complies
USP specifications keeping in view the labelled amount
of sodium in your product.
Justify the use of commercial lot of meropenem for The assay of meropenem trihydrate USP reference
injection (batch number SI/MPM/00060120) standard lot# J0K434, is 87.3% meropenem. Similarly,
manufactured by sterile India as working standard since by comparing with reference standard we prepare our
USP recommends that reference standard should be pure meropenem trihydrate working standard in which
meropenem trihydrate. 82.12% is meropenem present. Actually the material
used in USP Reference standard and the working
standard is the same as meropenem trihydrate because
the product label claim is meropenem, therefore we have
to calculate the assay against the purity of material as
meropenem which is 87.3% in USP Reference standard
and 82.12% in working standard.
Provide details that which lot number of drug substance Firm has not submitted details that which lot number of
has been used in manufacturing of each batch of drug drug substance has been used in manufacturing of each
product. Also provide documents confirming evidence of batch of drug product.
import of each lot of drug substance used in Further documents confirming import of these relevant
manufacturing of these batches of drug product. batches are also required.
Provide data of stability batches properly arranged and Firm has not yet submitted stability study data in proper
supported by respective documents including analytical sequence with COA for each time point, raw data sheets
report / COA, raw data sheet and respective and chromatograms. Raw data sheets are not submitted.
chromatograms separately for each time point, since the Further the calculation formula used for the calculation
submitted chromatograms and analytical reports are of assay result is also different from USP as well as the
without any proper sequence. method of sample and standard solution preparation.
Provide Reference of previous approval of applications No response submitted by the firm
Provide compliance Record of HPLC software 21CFR & No response submitted by the firm
Provide Record of Digital data logger for temperature No response submitted by the firm
and humidity monitoring of stability chambers (real time
and accelerated).
 Submission of differential fee as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
 Submission of COA of relevant batch of drug substance from drug substance manufacturer used in
the manufacturing of batches for which stability study data is submitted.
 Scientific justification for using commercial batch manufactured by M/s Sterile India as working
standard.
 Scientific justification for use of 5% overage in the formulation.
 Submission of complete protocols of process validation studies of the drug product.
 Submission of detailed method of analysis of the drug product with details of sample solution
preparation.
 Scientific justification for using calculation formula for assay testing which is different from that
 Revision of drug product specifications in the light of USP monograph and inclusion of test for
sodium content along with submission of fee of Rs. 7,500 for correction/pre-approval change/ in
product specifications, as per notification No.F.7-11/2012-B&A/DRAP dated 13-07-2021.
Registration Board.
1. Submission of differential fee as per Firm has submitted differential fee 5,000/- vide slip
notification No.F.7-11/2012-B&A/DRAP number 658476562996 dated 20-05-2022.
dated 13-07-2021.
2. Submission of COA of relevant batch of drug Firm has submitted COA of relevant batch of drug
substance from drug substance manufacturer substance generated by drug substance manufacturer.
used in the manufacturing of batches for which
3. Scientific justification for using commercial This firm has submitted that the assay of Meropenem
batch manufactured by M/s Sterile India as Trihydrate USP reference standard lot # J0k434 is
working standard. 87.3%. Therefore, we used sterile India material as
working Standard having potency 82.02% by using
standardization procedure with USP reference standard.
Material used for batch manufacturing is from
Aurobindo China and working standard prepared is of
Sterile India having Potency 82.02%
COA’s for Reference standard & working standard
along with standardization procedure is submitted by
the firm.
4. Scientific justification for use of 5% overage in Firm has submitted that an overage is used to cover
the formulation. losses during manufacturing. Initially we used extra 5%
of Meropenem to deliver our product with exact
quantity of API in injection, the idea behind was to
deliver exact quantity of the active substance. After that
product's shelf life, or to extend shelf life, is
discouraged. Overages are nothing but the extra
quantity of material taken, which is lost during process
stage.ICH Q8 guide line, provide a structured way to
define product critical quality attributes. We are not
using any overage in the manufacturing of Meropenem
injection
5. Submission of complete protocols of process Firm has submitted general protocols for process
validation studies of the drug product. validation. Firm has not submitted specific protocols
for the process validation of applied product.
6. Submission of detailed method of analysis of Firm has submitted detailed method of analysis of the
the drug product with details of sample solution drug product, However in the submitted method,
preparation. sample solution preparation method is still not clear
in terms of exact volume of water used to
reconstitute the contents of vial and then how to
make further dilutions. Furthermore, the calculation
formula use weight of sample and standard while USP
standard.
7. Scientific justification for using calculation Firm has submitted that they are using the potency of
formula for assay testing which is different working standard as percentage. USP taking the
from that specified in USP monograph. Potency into mg/mg which is covered into percentage
multiplying the ratio with 100 so there is no difference
between the USP formula & our standard operating
formula further more we have amended our SOP with
respect to the formula given in USP.
However, the newly used calculation formula use
weight of sample and standard while USP
standard. The new formula is also not exactly as per
USP monograph.
8. Revision of drug product specifications in the Firm has now added sodium content test in their
light of USP monograph and inclusion of test specifications. Firm has also submitted fee 7,500/- vide
for sodium content along with submission of fee slip number 45752149528 dated 20-05-2022.
of Rs. 7,500 for correction/pre-approval However, no data regarding the sodium content
change/ in product specifications, as per testing during stability studies is provided.
dated 13-07-2021.
9. Scientific justification for the analytical method Firm has not justified the previous validation reports,
verification studies of the drug product which is instead the firm has submitted new report in which the
not performed as per ICH guidelines. analysis is carried out on July 2022. The new report was
performed in line with ICH recommendations.
10. Submission of stability study data of three Firm has submitted data in section 3.2.P.8.3. The
commercial batches in section 3.2.P.8.3 as per evaluation os submitted data is as under:
the 6-points checklist provided in Form 5-F
guidance document (PE&R/GL/AF/004)
approved by the Registration Board.
Reference of previous approval of Not applicable

firm (if any)
Approval of API/ DML/GMP certificate of Firm has submitted copy of GMP certificate
API manufacturer issued by concerned (No. 3298/E1/2019) issued by Drugs Control
regulatory authority of country of origin. Administration, Government of Telangana
dated 11-02-2020. The certificate is valid till 3
years from the date of issue.
Documents for the procurement of API with 1705205135, 1705205096:
approval from DRAP (in case of import). Firm has submitted copy of commercial invoice
20Kg meropenem for lot number 1705205135,
1705205096. The invoice is cleared by AD
(I&E) DRAP.
1705203623:
Firm has submitted copy of commercial invoice
15Kg meropenem for lot number 1705203623.
The invoice is cleared by AD (I&E) DRAP.
Data of stability batches will be supported by Firm has submitted analytical record of
attested respective documents like product testing including HPLC chromatogram
chromatograms, Raw data sheets, COA, and raw data sheets
Compliance Record of HPLC software Not submitted
21CFR & audit trail reports on product testing
Record of Digital data logger for temperature Firm has submitted record of digital data
and humidity monitoring of stability chambers logger for stability chambers for accelerated
(real time and accelerated) and real time stability study.
 Clarification for use of 5% overage in sterile products and specifications of the manufactured
products in the light of approved specifications and pharmacopoeial monographs.
 Capacity assessment of manufacturing and testing facility of M/s Stallion Pharmaceuticals (Pvt) Ltd.
581, Sundar Industrial Estate, Raiwind Road Lahore.
 Submission of specific protocols for the process validation of applied product.
 Submission of preparation sample solution is required since it is not clear in terms of exact volume
of water used to reconstitute the contents of vial and then how to make further dilutions. Furthermore,
the calculation formula use weight of sample and standard while USP recommends to use
concentration of sample and standard.
 Clarification regarding use of formula which is different from the formula as recommended by USP
for calculation of assay.
1. Clarification for use of 5% overage in sterile An overage is used to cover losses during manufacturing.
products and specifications of the Initially we used extra 5% of Meropenem to deliver our
manufactured products in the light of product with exact quantity of API in injection, the idea
approved specifications and pharmacopoeial behind was to
monographs. deliver exact quantity of the active substance. After that
product's shelf life, or to extend shelf life, is discouraged.
Overages are nothing but the extra quantity of material
taken, which is lost during process stage.ICH Q8 guide
line, provide a structured way to define product critical
quality attributes. We are not using any overage in the
manufacturing of Meropenem injection
2. Capacity assessment of manufacturing and Capacity assessment report is not yet received.
testing facility of M/s Stallion
Pharmaceuticals (Pvt) Ltd. 581, Sundar
Industrial Estate, Raiwind Road Lahore.
3. Submission of specific protocols for the Firm has submitted process validation protocols
process validation of applied product.
4. Submission of preparation sample solution is Firm has submitted revised testing method and
required since it is not clear in terms of exact specifications dated 30-09-2022.
volume of water used to reconstitute the The revised method is again unclear about the sample
contents of vial and then how to make further solution preparation method since it is not clear in terms
dilutions. Furthermore, the calculation of exact volume of water used to reconstitute the contents
formula use weight of sample and standard of vial.
while USP recommends to use concentration
of sample and standard.
5. Clarification regarding use of formula which Firm has submitted revised testing method and
is different from the formula as specifications dated 30-09-2022.
recommended by USP for calculation of The formula used for calculation of assay of drug product
assay. is different from USP since USP recommends
concentration of sample and standard solution while the
firm is using weight of sample and standard solution.
Firm has again submitted another revised testing method
and specifications dated 23-11-2022 in which the testing
method is as per USP monograph along with test for
sodium contents.
Proceedings & Decision: Registration Board was apprised that the applied formulation has already
been approved in 312th meeting opf Registration Board for contract manufacturing from M/s Stallion
Pharmaceuticals Pvt Ltd. on basis of Form 5F (CTD) of M/s Healthtek (Pvt) Ltd., Karachi as
applicant, wherein following submission had also been made by the firm and above mentioned points
have been addressed and responded:
1. Evidence for purchase of atomic absorption spectrophotometer in the form of purchase order
dated 14-06-2021, deliver challan dated 19-06-2021 & invoice No. 06/3029 dated 18-06-2021.
2. Installation and operational qualification reports of atomic absorption spectrophotometer
3. Analysis report of Sodium Content in Mopen (Meropenem) Injection by M/s Stallion
Pharmaceuticals (Pvt) Ltd., 581- Sundar Industrial Estate, Lahore.
On basis of above cited reference Registration Board decided to approve instant application.
Registration Board further authorized its Chairman for issuance of registration letters upon
satisfactory capacity assessment of manufacturing and testing facility of M/s Stallion Pharmaceuticals
(Pvt) Ltd., 581- Sundar Industrial Estate, Lahore wherein panel shall also review the testing of drug
substance and drug product of applied formulation as per pharmacopoeial requirements.
Case No. 03 Export facilitation cases
Case No. 1: M/s Herbion Pakistan Pvt Ltd. Industrial Triangle, Kahuta Road, Islamabad
Assistant Director PR-I / EFD vide its letter No. F.1-6/2019-PR-I (EFD) dated 6th October 2022 informed
that as per decision of 133rd meeting of DRAP Authority wherein it was decided to grant registration on
priority basis to the pharmaceutical i.e. one molecule for each 100,000 USD worth of export of medicine (to
a maximum of 15 such molecules) during a financial year.
In compliance to the above decision M/s Herbion Pakistan Pvt Ltd. Islamabad have achieved benchmark of
more than 100,000 USD and submitted their applications for priority consideration including following
applications:
 Diance-Met 12.5/500mg Tablet
 Diance-Met 12.5/1000mg Tablet
 Diance-Met 5/1000mg Tablet
749. Name, address of Applicant / Marketing M/s Herbion Pakistan Pvt Ltd.
Authorization Holder Industrial Triangle, Kahuta Road, Islamabad
Name, address of Manufacturing site. M/s Herbion Pakistan Pvt Ltd.
Industrial Triangle, Kahuta Road, Islamabad
☐ Importer
GMP status of the firm The firm has submitted copy of GMP certificate
dated 17-07-2019. The certificate is valid till 20-
05-2022.
Evidence of approval of manufacturing facility Firm has submitted copy of grant of revised /
relocated section letter dated 09-04-2020 in which
Tablet (general) section is specified.
☐ Export sale
The proposed proprietary name / brand name DIANCE-MET 5/1000mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…5mg
Metformin HCl…1000mg
Pharmaceutical form of applied drug Beige yellow oblong shaped plain on both sides
Pharmacotherapeutic Group of (API) Antidiabetic
Proposed Pack size 14’s (2x7’s)
For generic drugs (me-too status) Xelglu-Met Tablet by Hilton
Name and address of API manufacturer. Empagliflozin: Fuxin Long Rui Pharmaceutical
Co. Ltd. Fluoride Industrial Park, Fumeng County
Fuxin City Liaoning Province China.
Metformin: Aarti Drugs Limited Plot No. 211 -
213, Road No.2G.I.D.C., Sarigam, Dist.: Valsad,
Gujarat. INDIA.39615
product.
Stability Studies of Drug Substance Empagliflozin: Firm has submitted stability study
(Conditions & duration of Stability studies) data of 3 batches of drug substance at both
accelerated as well as real time conditions. The
accelerated stability data is conducted at 40°C ±
2°C / 75% ± 5% RH for 6 months. The real time
stability data is conducted at 30°C ± 2°C / 65 ± 5%
RH for 24 months.
Metformin: Firm has submitted stability study
data of 3 batches of drug substance at both
RH for 48 months.
product against Xenglu-Met Tablet of Hilton
Pharma.
Pharma.
product substance and analytical method validation of the
drug product.
Manufacturer of API Empagliflozin: Fuxin Long Rui Pharmaceutical Co. Ltd. Fluoride Industrial
Park, Fumeng County Fuxin City Liaoning Province China.
Metformin: Aarti Drugs Limited Plot No. 211-213, Road No.2G.I.D.C.,
Sarigam, Dist.: Valsad, Gujarat. INDIA.
API Lot No. Empagliflozin: H-E-20201125-D03-E06-01
Metformin: 10010279
Description of Pack
Alu-alu blister pack
Batch No. DIAM(5/1000)-ST-001 DIAM(5/1000)-ST-002 DIAM(5/1000)-ST-003
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to their previous onsite inspection
with stability study data of the firm (if any) for Vocab 10 and 20mg tablet which was conducted
on 15-11-2021 and was considered by the Board in
its 313rd meeting. The report cofirms following
points:
 FPP testing had been conducted on HP-QCE-
048 (shimadzu LC-2030) and HP-QCE-001
(shimadzu 2080), which were 21 CFR
compliant.
 The audit trail report was reproduced at the time
of inspection.
2. Approval of API/ DML/GMP certificate of API Empagliflozin: Copy of DML certificate No.
manufacturer issued by concerned regulatory Liao20150233, dated: 21/12/2017 valid till
authority of country of origin. 20/12/2022, issued by Food & Drug Administration
of Liaoning Province- China is submitted.
Metformin: Copy of GMP Certificate (No.
20031933) for M/s Aarti Drugs Limited issued by
Food and Drug Control Administration, Gujrat
State India is submitted. It is valid till 19-03-2023.
3. Documents for the procurement of API with Empagliflozin: Firm has also submitted copy of
approval from DRAP (in case of import). commercial invoice specifying import of 0.38Kg
Empagliflozin. The invoice is cleared by AD (I&E)
DRAP dated 20-04-2021.
Metformin: Firm has also submitted copy of
commercial invoice specifying import of 25Kg
Metformin HCl. The invoice is cleared by AD
(I&E) DRAP dated 07-10-2020.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted HPLC audit trail reports and 21
audit trail reports on product testing CFR compliance certificate
Evaluation by PEC(III)::
The application was initially submitted on 25-11-2019 without product development and stability study data.
The firm was issued a letter of shortcoming dated 26-12-2019. Later the firm submitted complete data on
18th April 2022 and the data was evaluated and following further shortcomings were communicated to the
firm. The response of the firm is tabulated below:

Submit drug substance specifications and analytical The firm has submitted specifictations and analytical
method from drug product manufacturer for metformin method of metformin hydrochloride from Herbion
hydrochloride. Pharma.
Submit verification studies of analytical method of Firm has submitted verification studies of the analytical
metformin hydrochloride drug substance. method of metformin hydrochloride drug substance.
Submit stability study data of metformin hydrochloride Firm has submitted metformin hydrochloride drug
drug substance as per zone IV-A conditions. substance stability study data as per zone IV-A
conditions.
Submit GMP certificate for API manufacturer of Copy of GMP Certificate (No. 20031933) for M/s Aarti
metformin hydrochloride. Drugs Limited issued by Food and Drug Control
Administration, Gujrat State India is submitted. It is valid
till 19-03-2023.
Clarify the exact source of empaglifloin drug substance, Firm has submitted that Beijing Huikang is the DMF
since Beijing Huikang Pharmaceuticals is mentioned in holder / supplier for this drug substance while it is
module 1 and 3. manufactured at Fuxin Long Rui Pharmaceutical Co.
Ltd. Fluoride Industrial Park, Fumeng County Fuxin City
Liaoning Province China. The commercial invoice and
clearance certificate issued by AD (I&E) also specify that
the manufacturer is Fuxin Long Rui Pharmaceutical.
Submit copy of BMR of three stability batches Firm has submitted copy of BMR of the three batches
Deferred for consideration on its turn since the product development and stability study data was submitted
in April 2022.
Firm has requested to consider their application of priority basis as per export facilitation as per the letter of
Assistant Director PR-I / EFD (letter No. F.1-6/2019-PR-I (EFD) dated 6th October 2022) wherein it was
informed that M/s Herbion Pakistan Pvt Ltd. Islamabad have achieved benchmark of more than 100,000
USD and submitted their applications for priority consideration as per decision of 133rd meeting of DRAP
Authority wherein it was decided to grant registration on priority basis to the pharmaceutical i.e. one
molecule for each 100,000 USD worth of export of medicine (to a maximum of 15 such molecules) during
a financial year.
The application was already evaluated and presented by the Board and was deferred for consideration on its
turn since the product development and stability study data was submitted in April 2022.
Decision: Approved.
☐ Importer
05-2022.
☐ Export sale
The proposed proprietary name / brand name DIANCE-MET 12.5/500mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…12.5mg
Pharmaceutical form of applied drug White colored, oblong shaped break line on one
side and other side is plain.
product.
RH for 24 months.
RH for 48 months.
Pharma.
Pharma.
drug product.
Metformin: 10010279
Description of Pack
Batch No. DIAM(12.5/500)-ST- DIAM(12.5/500)-ST- DIAM(12.5/500)-ST-
001 002 003
No. of Batches 03
points:
compliant.
of inspection.
(I&E) DRAP dated 07-10-2020.
data sheets etc.
The firm was issued a letter of shortcoming dated 26-12-2019. Later the firm submitted complete data in 18th
April 2022 and the data was evaluated and following further shortcomings were communicated to the firm.
The response of the firm is tabulated below:

conditions.
Administration, Gujrat State India is submitted. It is
in April 2022.
a financial year.
Decision: Approved.
☐ Importer
05-2022.
☐ Export sale
The proposed proprietary name / brand name DIANCE-MET 12.5/1000mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…12.5mg
Pharmaceutical form of applied drug Oblong shaped, blue colored film coated tablets,
plain on both sides
product.
RH for 24 months.
RH for 48 months.
Pharma.
Pharma.
drug product.
Metformin: 10010279
Description of Pack
Batch No. DIAM(12.5/1000)-ST- DIAM(12.5/1000)-ST- DIAM(12.5/1000)-ST-
001 002 003
No. of Batches 03
points:
compliant.
of inspection.
(I&E) DRAP dated 07-10-2020.
data sheets etc.
The firm was issued a letter of shortcoming dated 26-12-2019. Later the firm submitted complete data in 18th
April 2022 and the data was evaluated and following further shortcomings were communicated to the firm.
The response of the firm is tabulated below:

conditions.
Administration, Gujrat State India is submitted. It is valid
till 19-03-2023.
in April 2022.
a financial year.
Decision: Approved.
Case No. 2: M/s Swiss Pharmaceuticals Pvt Ltd. A-159, S.I.T.E Super Highway, Karachi
Assistant Director PR-I / EFD vide its letter No. F.1-6/2019-PR-I (EFD) dated 6th October 2022 informed that as per
decision of 133rd meeting of DRAP Authority wherein it was decided to grant registration on priority basis to the
pharmaceutical i.e. one molecule for each 100,000 USD worth of export of medicine (to a maximum of 15 such
molecules) during a financial year.
In compliance to the above decision M/s Swiss Pharmaceuticals Pvt Ltd., Karachi have achieved benchmark of more
than 100,000 USD and submitted their applications for priority consideration including following applications:
752. Name and address of manufacturer M/s Swiss Pharmaceuticals Pvt Ltd.
/ Applicant A-159, S.I.T.E Super Highway, Karachi
Brand Name +Dosage Form + Swistat 10mg Tablet
Strength
Atorvastatin as calcium trihydrate…10mg
Diary No. Date of R& I & fee Dy No. 16859: 07-03-2019
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Finished Product Specification USP
Approval status of product in MHRA Approved
Me-too status Lipiget Tablet by Getz
GMP status GMP certificate issued on basis of inspection conducted on
18-03-2022.
Remarks of the Evaluator3.
Decision: Approved.
Strength
PKR 20,000/-: 07-03-2019
Type of Form Form 5
18-03-2022.
Decision: Approved.
Strength
PKR 20,000/-: 07-03-2019
Type of Form Form 5
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Zine 10mg Tablet
Strength
Cetirizine HCl…10mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Piperazine derivatives
Type of Form Form 5
Me-too status Baydal Tablet by Bayer
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Zine 5mg Syrup
Strength
Cetirizine HCl…5mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Piperazine derivatives
Type of Form Form 5
Finished Product Specification BP
Me-too status Baydal Syrup by Bayer
18-03-2022.
Remarks of the Evaluator3. 
Decision: Approved.
Brand Name +Dosage Form + Swicar 50mg/ml Injection
Strength
Iron As Ferric Carboxymaltose…50mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Iron preparations
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications
Pack size & Demanded Price 10ml: As per SRO
Approval status of product in USFDA Approved
Me-too status Bio-Maltose Injection by Bio-Lab
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Asmide 50mg Tablet
Strength
Lacosamide…50mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Lacolep tablet by Hilton
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Asmide 100mg Tablet
Strength
Lacosamide…100mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Lacolep tablet by Hilton
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Asmide 10mg/ml Injection
Strength
Lacosamide…10mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Pack size & Demanded Price 20ml: As per SRO
Me-too status Lacolep Injection by Hilton
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Telmi 20mg Tablet
Strength
Telmisartan…20mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs)
Type of Form Form 5
Me-too status Telsan Tablet by Hilton
18-03-2022.
Decision: Approved.
Strength
Telmisartan…40mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
18-03-2022.
Decision: Approved.
Strength
Telmisartan…80mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
18-03-2022.
Decision: Approved.
Brand Name +Dosage Form + Telmi-H 40/12.5 mg Tablet
Strength
Telmisartan…40mg
Hydrochlorothiazide…12.5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Co-Telsan Tablet by Hilton
18-03-2022.
Decision: Approved.
Case No. 04 Registration applications of locally manufactured products applied on Form 5
a. New cases in which firm has submitted replies
765.Name and address of manufacturer / M/s Pliva Pakistan Pvt Ltd

Applicant Plot # B-77, Hub Industrial Trading Estate, Baluchistan
Brand Name +Dosage Form + Strength Mapez 0.5mg Tablet
Clonazepam…0.5mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Benzodiazepine derivatives
Type of Form Form 5
Me-too status Rivotril Tablet by Martin Dow
GMP status Last inspection report dated 15-02-2022 concludes that the
overall GMP of the firm is rated as good.
Remarks of the Evaluator3.  Firm has Tablet (psychotropic) section.
Decision: Approved.
Brand Name +Dosage Form + Strength Mapez Tablet 2mg
Clonazepam…2mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Rivotril Tablet by Martin Dow
Decision: Approved.
Brand Name +Dosage Form + Strength Plitox Tablet 2.5/0.25mg
Diphenoxylate HCl…2.5mg
Atropine Sulphate…0.25mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Antipropulsives
Type of Form Form 5
Me-too status Lomotil Tablet by Searle
Remarks of the Evaluator3.  Reference of finished product specifications.
 Revise your label claim along with submission of full fee as per the
innovator’s product as per following:
Each Tablet Contains:
Diphenoxylate HCl…2.5mg
Atropine Sulphate…0.025mg
Decision: Deferred for revision of formulation as per the Innovator’s product along with submission of
fee 30,000/- as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Plioxicam 15mg tablet
Meloxicam…15mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Melor Tablet by Sami
Decision: Approved.
Brand Name +Dosage Form + Strength Methadate Tablet 10mg
Methylphenidate HCl…10mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Centrally acting sympathomimetic
Type of Form Form 5
Me-too status Ritalin Tablet by Novartis
Decision: Approved.
Brand Name +Dosage Form + Strength Metazole Tablet 400mg
Metronidazole…400mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Imidazole derivatives
Type of Form Form 5
Me-too status Flagyl Tablet by Sanofi Aventis
Remarks of the Evaluator3.  Reference product is available as film coated tablet while you have
applied for uncoated tablet. Revise your formulation as per the
reference product along with submission of 7,500/- fee.
Each Film Coated Tablet Contains:
Metronidazole…400mg
 Firm shall submit 7,500/- fee for revision of formulation from uncoated to film coated tablet as
Brand Name +Dosage Form + Strength Plaflox 400mg Tablet
Moxifloxacin As HCl…400mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Avelox Tablet by Bayer
Remarks of the Evaluator3.  Reference product is available as film coated tablet while you have
Moxifloxacin as HCl…400mg
Brand Name +Dosage Form + Strength Temaz 15mg Capsule
Composition Each Capsule Contains:
Temazepam…15mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Approval status of product in Restoril Capsule USFDA Approved.
Me-too status Restoril Capsule by Novartis
Remarks of the Evaluator3.  Evidence of approval of requisite manufacturing facility / section
approval from Licensing Division DRAP.
Decision: Registration Board rejected the application since firm does not have approval for required
manufacturing facility / section i.e., “Capsule (Psychotropic) section” from CLB.
773.Name and address of manufacturer / M/s Pliva Pakistan Pvt Ltd Plot # B-77, Hub Industrial Trading
Applicant Estate, Baluchistan
Brand Name +Dosage Form + Strength Temaz Capsule 30mg
Temazepam…30mg
PKR 20,000/-: 07-03-2019
Pharmacological Group
Type of Form Form 5
Approval status of product in Restoril Capsule USFDA Approved.
Me-too status Restoril Capsule by Novartis
Remarks of the Evaluator3.  Evidence of approval of requisite manufacturing facility / section
approval from Licensing Division DRAP.
manufacturing facility / section i.e., “Capsule (Psychotropic) section” from CLB.
Brand Name +Dosage Form + Strength Polfi 10mg Tablet
Zolpidem Tartrate…10mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Benzodiazepine related drugs
Type of Form Form 5
Me-too status Stilnox Tablet by Sanofi Aventis
 Reference product is available as film coated tablet while you have
Zolpidem Tartrate…10mg
775.Name and address of manufacturer / M/s Moon Pharmaceuticals
Applicant Plot No. 5, SS-4 Road, National Industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Strength Betagen Cream 0.5mg/1mg
Betamethasone…0.5mg
Gentamicin…1mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Corticosteroids, Combinations With Antibiotics
Type of Form Form 5
Finished Product Specification Firm has claimed in house specifications (JP Monograph for
Betamethasone Valerate and Gentamicin Sulfate Cream)
Approval status of product in MHRA Mibetin 1 mg/g + 0.5 mg/g Cream (gentamicin sulfate,
Reference Regulatory Authorities. betamethasone dipropionate).
Me-too status
GMP status
1. Latest GMP inspection report conducted Firm has submitted inspection report dated 11-
within a period of last three years. 12-2019 conducted to verify rectification status
of observations noted in previous inspection. The
panel in its written statement on inspection book
mentioned that the firm is operating at acceptable
level of GMP as of today. The panel in its
detailed report concluded that firm has rectified
majority of observations and the report is being
forwarded to competent authority for resumption
of production activities in Oral Liquid Syrup
section.
2. Reference of finished product specifications. Firm has submitted USP monograph of API and
betamethasone cream and gentamicin ointment
separately, however for the applied product no
reference has been submitted.
3. Clarify the salt form of betamethasone as Firm has submitted revised label claim in which
well as gentamicin, since both salt form has been clarified. The revised label
claim is as follows:
betamethasone dipropionate and Each gram of cream contains:
betamethasone valerate are available. Betamethasone (as dipropionate)…0.5mg
Gentamicin (as sulphate)……1mg
Firm has NOT submitted any fee for
correction of salt form.
4. Evidence of requisite manufacturing facility / Firm has submitted letter of issuance of DML
section approval letter from Licensing dated 24-08-2016 specifying Tablet (General),
Division DRAP. Capsule (General), Topical (General), Sachet
(General), Liquid Syrup (General) and Oral dry
powder for suspension (General) section.
5. Evidence of applied formulation/drug Effigenta Cream by Mass Pharma (Reg #
already approved by DRAP (generic / me- 024735)
too status) alongwith registration number,
brand name and name of firm.
Decision: Approved with Innovator’s specifications and with following label claim:
Betamethasone (as dipropionate)…0.5mg
Gentamicin (as sulphate)……1mg
 Firm shall submit 30,000/- fee for correction in salt form as per notification No.F.7-11/2012-
 Registration letter will be issued after submission of latest GMP inspection report conducted
Islamabad
Brand Name +Dosage Form + Strength Moncep 125mg/5ml Dry Suspension
Ciprofloxacin as Hcl…250mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Approval status of product in Registration Board in 269th meeting approved the formulation of
Reference Regulatory Authorities. ciprofloxacin 125mg/5ml granules and solvent for oral suspension
Me-too status Novidat suspension by Sami
GMP status
section.
2. Reference of finished product specifications. Firm has submitted USP specifications.
3. The applied brand name is Moncep Firm has submitted that the applied formulation
125mg/5ml Dry Suspension while the label contains 125mg and the correct label claim is as
claim specifies Ciprofloxacin as HCl 250mg. under:
Clarification is required in this regard. Each 5ml Contains:
Ciprofloxacin..…125mg
Firm has revised the salt form from
Ciprofloxacin HCl to base.
Firm has not submitted fee for this revision.
4. The innovator’s product is supplied with a No response submitted against this query.
diluent while your product does not depict
the use of any diluent. Clarification is
required in this regard..
Each 5ml Contains:
Ciprofloxacin..…125mg
 Firm shall market the product along with diluent as per the innovator’s product as per the
decision of 290th and 313th meeting of Registration Board.
Islamabad
Brand Name +Dosage Form + Strength Moncep 250mg/5ml Dry Suspension
Ciprofloxacin …250mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Novidat suspension by Sami
GMP status

section.
2. Reference of finished product specifications. Firm has submitted USP specifications.
3. Innovator’s product contains ciprofloxacin Firm has revised the salt form from
base while you have applied for HCl salt of Ciprofloxacin HCl to base.
ciprofloxacin. Revise your formulation along Firm has not submitted fee for this revision.
with submission of full fee of registration.
4. The innovator’s product is supplied with a No response submitted against this query.
diluent while your product does not depict
the use of any diluent. Clarification is
required in this regard..
Decision: Approved
 Firm shall market the product along with diluent as per the innovator’s product as per the
decision of 290th and 313th meeting of Registration Board.
Islamabad
Brand Name +Dosage Form + Strength Difen K 50mg Tablet
Diclofenac Potassium…50mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Diclorep Tablet by Sami
GMP status Firm has submitted inspection report dated 11-12-2019
conducted to verify rectification status of observations noted in
previous inspection. The panel in its written statement on
inspection book mentioned that the firm is operating at
acceptable level of GMP as of today. The panel in its detailed
report concluded that firm has rectified majority of
observations and the report is being forwarded to competent
authority for resumption of production activities in Oral Liquid
Syrup section.
Decision: Approved. Registration letter will be issued after submission of latest GMP inspection report
Islamabad
Brand Name +Dosage Form + Strength Isotret E Gel 0.5/20mg
Composition Each gram of gel contains:
Isotretinoin…0.5mg
Erythromycin…20mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Retinoids for topical use in acne
Type of Form Form 5
Me-too status Oratraxin gel by Crystolite
GMP status

1. Evidence of approval of applied formulation Firm has not submitted any response
in reference regulatory authorities/agencies
which were adopted by the Registration
authorities/agencies which were adopted by the Registration Board in its 275 th meeting.
Islamabad
Brand Name +Dosage Form + Strength Monitra 100mg Capsule
Itraconazole (as IR pellets)…100mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Antimycotics For Systemic Use
Type of Form Form 5
Me-too status Icon Capsule by Ferozesons
Syrup section.
Remarks of the Evaluator3. Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
Islamabad
Brand Name +Dosage Form + Strength Monlet 125mg Tablet
Letrozole…2.5mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Aromatase inhibitors
Type of Form Form 5
Me-too status Femara Tablet by Novartis
Syrup section.
1. The brand name and covering letter specifies Firm has submitted that it was a typo mistake.
Monlet 125mg Tablet while in label claim
firm have mentioned Letrozole 2.5mg.
Islamabad
Brand Name +Dosage Form + Strength Lormex 8mg Tablet
Composition Each Film coated Tablet Contains:
Lornoxicam…8mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Approval status of product in Xefo 8mg Film-Coated Tablet, Takeda Austria GmbH, Austria
Reference Regulatory Authorities. approved.
Me-too status Zafon Tablets by Getz
Syrup section.
1. Revise your label claim to film coated tablet Firm has revised the label claim to film coated
as per the reference product along with tablet how firm has not submitted fee.
submission of 7,500/- fee.
Decision: Approved with Innovator’s specifications. Firm shall submit 7,500/- fee for revision of
formulation from uncoated tablet to film coated tablet as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021alongwith latest GMP inspection report conducted within last three years before issuance
Islamabad
Brand Name +Dosage Form + Strength Monpro 20mg Sachet
Composition Each Sachet Contains:
Omeprazole…20mg
PKR 20,000/-: 07-03-2019
Pharmacological Group PPI
Type of Form Form 5
Approval status of product in USFDA
Me-too status Risek Insta Sachet by Getz
Syrup section.
Islamabad
Brand Name +Dosage Form + Strength Monpro Max Sachet 40/1680mg
Omeprazole…40mg
Sodium Bicarbonate…1680mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Approval status of product in USFDA
Me-too status Risek Insta Sachet by Getz
Syrup section.
Islamabad
Brand Name +Dosage Form + Strength Monlin 100mg Capsule
Pregabalin…100mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Anticonvulsant
Type of Form Form 5
Me-too status Gabica Capsule by Getz
Syrup section.
Remarks of the Evaluator3.  Firm has initially claimed in house specifications while the product
monograph is available in latest edition of BP monograph. Firm has
now revise the specifications to BP along with submission of
7,500/- fee.
Islamabad
Brand Name +Dosage Form + Strength Metsita 50/1000mg Tablet
Sitagliptin as Phospate Monohydrate…50mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Treivamet Tablet by Getz
Syrup section.
Decision: Approved with Innovator’s specifications. Registration letter will be issued after submission of
latest GMP inspection report conducted within last three years alongwith Rs. 7,500/- fee for revision of
Islamabad
Brand Name +Dosage Form + Strength Martilate sachet 2g
Strontium Renelate…2g
PKR 20,000/-: 07-03-2019
Pharmacological Group Other drugs affecting bone structure and mineralization
Type of Form Form 5
Me-too status Onita Sachet by Pharmevo
Syrup section.
latest GMP inspection report conducted within last three years alongwith Rs. 7,500/- fee for revision of
Islamabad
Brand Name +Dosage Form + Strength Muodart 0.4mg Capsule
Tamsulosin HCl Modified Release Pellets Eq To
Tamsulosin……0.4mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Alpha-adrenoreceptor antagonists
Type of Form Form 5
Me-too status Maxflow Capsule by CCL
Syrup section.
Islamabad
Brand Name +Dosage Form + Strength Monofin 125mg Tablet
Terbinafine HCl…125mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Antifungal
Type of Form Form 5
Approval status of product in LAMISIL terbinafine 125mg (as hydrochloride) tablet blister pack
Reference Regulatory Authorities. TGA Australia Approved
Me-too status Terbitec Tablet by Fynk Pharma
Syrup section.
Remarks of the Evaluator3.  Firm has initially applied for film coated tablet, later the firm
revised formulation to uncoated tablet along with submission of
7,500/- fee.
Decision: Approved.
 Firm shall submit 7,500/- fee for revision of formulation from film coated tablet to un-coated
tablet as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Islamabad
Brand Name +Dosage Form + Strength Ezicoside 4mg Capsule
Thiocolchicoside…4mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Muscle Relaxants, Centrally Acting Agents
Type of Form Form 5
Approval status of product in MIOREL 4 mg, capsule ANSM France Approved
Me-too status Thiolax Capsule by S.J&G Fazul Ellahie
Syrup section.
latest GMP inspection report conducted within last three years.
791.Name and address of manufacturer / M/s Winlet Pharmaceuticals.
Applicant 30-km, Lahore Sargodha Road, Lahore
Brand Name +Dosage Form + Strength Surlid 50mg Tablet
Amisulpride…50mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antipsychotics
Type of Form Form 5
Me-too status Solium-50 Tablets by Genome Pharmaceuticals
GMP status Firm has submitted last inspection report dated 12-10-2017 and
12-12-2017 in which the panel recommended the grant of new
DML to the firm.
Remarks of the Evaluator3.  Firm has further submitted that their GMP inspection is planned in
November 2022 and they will submit report after inspection.
 Firm has revise formulation from film coated tablet to uncoated
tablet as per the reference product. However, firm has NOT
submitted fee for this revision.
Decision: Approved.
Amisulpride…200mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Amiride Tablet 200mg by Shrooq Pharmaceuticals
DML to the firm.
Decision: Approved.
Amisulpride…400mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Amiride Tablet 00mg by Shrooq Pharmaceuticals
DML to the firm.
Decision: Approved.
Brand Name +Dosage Form + Strength Olmepin 5/20 mg Tablet
Amlodipine As Besylate…5mg
Olmesartan Medoxomil…20mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs) and calcium channel
blockers
Type of Form Form 5
Approval status of product in USFDA Approved.
Me-too status Baritec-A Tablets by Barrett Hodgson
DML to the firm.
Brand Name +Dosage Form + Strength Olmepin 10/40 mg Tablet
PKR 20,000/-: 06-03-2019
blockers
Type of Form Form 5
DML to the firm.
Brand Name +Dosage Form + Strength Telpin 5/40 mg Tablet
Composition Each Bilayered Tablet Contains:
Telmisartan…40mg
PKR 20,000/-: 06-03-2019
blockers
Type of Form Form 5
Me-too status Am-Telsan Tablet by Hilton
DML to the firm.
 Firm has submitted that bilayer tablet compression machine in a
phase of purchase.
Decision: Deferred for submission of evidence of purchase along with IQ, OQ and PQ for the bilayer
tablet machine.
Brand Name +Dosage Form + Strength Telpin 10/80 mg Tablet
Composition Each Bilayered Tablet Contains:
Telmisartan…80mg
PKR 20,000/-: 06-03-2019
blockers
Type of Form Form 5
Me-too status Am-Telsan Tablet by Hilton
DML to the firm.
 Firm has submitted that bilayer tablet compression machine in a
phase of purchase.
Decision: Deferred for submission of evidence of purchase along with IQ, OQ and PQ for the bilayer
tablet machine.
Brand Name +Dosage Form + Strength Lodisar 5/12.5/160 mg Tablet
Amlodipine…5mg
Valsartan…160mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Angiotensin II receptor blockers (ARBs), other combinations
Type of Form Form 5
Me-too status Co-Extor Tablet by Searle
DML to the firm.
 Firm has revised the label claim as per follow without submission
of full fee of registration:
Amlodipine (as besylate)…5mg
Valsartan…160mg

Amlodipine (as besylate)…5mg
Valsartan…160mg
 Registration letter will be issued after submission of latest GMP inspection report conducted within
last three years.
 Firm shall submit 30,000 fee for correction in salt form as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Rela 8mg Tablet
PKR 20,000/-: 06-03-2019
Pharmacological Group Antivertigo preparations
Type of Form Form 5
Me-too status Serc Tablet by Abbott
DML to the firm.
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
Brand Name +Dosage Form + Strength Dobil 500mg Capsule
Calcium Dobesilate As Monohydrate…500mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antivaricose Therapy
Type of Form Form 5
Finished Product Specification Firm has claimed in-house specifications
Approval status of product in Doxium® 500 mg capsule Swissmedic Approved
Me-too status Doxium capsule by AGP
DML to the firm.
 Firm has revised label claim as per follow without submission of
full fee of registration:
Each Capsule Contains:
Calcium Dobesilate Monohydrate…500mg
Calcium Dobesilate Monohydrate…500mg
last three years.
Brand Name +Dosage Form + Strength Citawell 500mg/5ml Syrup
Composition Each 5ml Syrup Contains:
Citicoline As Sodium…500mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form 5
Approval status of product in SOMAZINE 100 mg/ml Oral Solution CIMA Spain Approved
Me-too status Citicode Syrup by Rotex Pharma
DML to the firm.
 Firm will submit 7,500/- fee for revision of specifications as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Clowin 75mg Tablet
Clopidogrel As Bisulphate…75mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Platelet aggregation inhibitors excl. heparin
Type of Form Form 5
Me-too status Lowplat tablet by Pharmevo
DML to the firm.
Brand Name +Dosage Form + Strength Benz 15mg Capsule
Composition Each Extended Release Capsule Contains:
Cyclobenzaprine HCl Pellets Eq. To Cyclobenzaprine…15mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Cyclorest ER Capsule by Martin Dow
DML to the firm.
Remarks of the Evaluator3. Source of Pellets: M/s Vision Pharma, Islamabad.
 Firm has further submitted that their GMP inspection is planned in
 Firm has revise label claim as per follow without submission of full
fee of registration:
Cyclobenzaprine HCl (as extended release pellets)…15mg

last three years.
Brand Name +Dosage Form + Strength Benz 30mg Capsule
Composition Each Extended Release Capsule Contains:
Cyclobenzaprine Hcl Pellets Eq. To Cyclobenzaprine…30mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Cyclorest ER Capsule by Martin Dow
DML to the firm.
Remarks of the Evaluator3. Source of Pellets: M/s Vision Pharma, Islamabad.

Cyclobenzaprine HCl (as extended release pellets)……30mg
last three years.
Brand Name +Dosage Form + Strength Desinaf 50mg Tablet
Composition Each Extended Release Tablet Contains:
Desvenlafaxine As Succinate…50mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antidepressants
Type of Form Form 5
Me-too status Desven XR Tablet by PharmEvo
DML to the firm.
 Firm has revise label claim as per follow without submission of
7500/- fee of registration:
Each Extended Release Film Coated Tablet Contains:
Desvenlafaxine as Succinate…50mg
last three years.
 Firm shall submit 7,500 fee for revision from uncoated extended release tablet to film coated
extended release tablet as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Desinaf 100mg Tablet
PKR 20,000/-: 06-03-2019
Pharmacological Group Antidepressants
Type of Form Form 5
Me-too status Desven XR Tablet by PharmEvo
DML to the firm.
 Firm has revise label claim as per follow without submission of
7500/- fee of registration:
Desvenlafaxine as Succinate…100mg
last three years.
 Firm shall submit 7,500 fee for revision from uncoated extended release tablet to film coated
extended release tablet as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Dexiwen 200mg Tablet
Dexibuprofen…200mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Tercica Tablet by Sami
DML to the firm.
Brand Name +Dosage Form + Strength Dexiwen 400mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
Brand Name +Dosage Form + Strength Dilet 50mg Capsule
Diacerein…50mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-steroids
Type of Form Form 5
Approval status of product in Diacerein Biogaran 50 mg, capsule ANSM Approved.
Me-too status Diora Capsule by Getz
DML to the firm.
Brand Name +Dosage Form + Strength Diclolet 50mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Maxit Tablet by Hilton
DML to the firm.
Brand Name +Dosage Form + Strength Domcelium 10mg Tablet
Domperidone…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Propulsives
Type of Form Form 5
Me-too status Domel Tablet by Barrett Hodgson
DML to the firm.
Domperidone (as maleate)…10mg

Domperidone (as maleate)…10mg
 Firm will submit 30,000/- fee for correction in salt form as per notification No.F.7-11/2012-
Brand Name +Dosage Form + Strength Doxyfit 100mg/5ml Syrup
Doxofylline…100mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other Systemic Drugs For Obstructive Airway Diseases
Type of Form Form 5
Approval status of product in AIFA Italy Approved
Me-too status Unifyline Syrup by Platinum
DML to the firm.
Brand Name +Dosage Form + Strength Doxyfit 400mg Tablet
Doxofylline…400mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other Systemic Drugs For Obstructive Airway Diseases
Type of Form Form 5
Approval status of product in AIFA Italy Approved
Me-too status Xofi Tablet by Hilton
DML to the firm.
Brand Name +Dosage Form + Strength Pylit 10/10 mg Tablet
Composition Each Delayed Release Film Coated Tablet Contains:
Doxylamine Succinate…10mg
Pyridoxine HCl…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antihistamines For Systemic Use
Type of Form Form 5
Me-too status Vomifit Tablet by Hilton
DML to the firm.
Brand Name +Dosage Form + Strength Dulet 40mg Capsule
Duloxetine HCl As Enteric Coated Pellets Eq. To Duloxetine…40mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other antidepressant
Type of Form Form 5
Me-too status Dulan Capsule by Hilton
DML to the firm.
Brand Name +Dosage Form + Strength Wincet 5mg Tablet
Escitalopram As Oxalate…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Citanew Tablet by Hilton
DML to the firm.
Brand Name +Dosage Form + Strength Gemlok 320mg Tablet
Gemifloxacin Mesylate Eq. To Gemifloxacin…320mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in Discontinued in FDA / applicant withdraw its application for
Reference Regulatory Authorities. Marketing authorization in EMA
Me-too status Gemixa tablet by Bosch Pharma
DML to the firm.
authorities/agencies which were adopted by the Registration Board
Decision: Deferred for evidence of approval of applied formulation in reference regulatory authorities /
Brand Name +Dosage Form + Strength Limet 2mg Tablet
Glimepiride…2mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Econid Tablet by Highnoon
DML to the firm.
Brand Name +Dosage Form + Strength Limet 4mg Tablet
Glimepiride…4mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Econid Tablet by Highnoon
DML to the firm.
Brand Name +Dosage Form + Strength Ibron 150mg Tablet
Ibandronic Acid As Ibandronic Sodium Monohydrate…150mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Ibnate Tablets by Geniz Pharma
DML to the firm.
Brand Name +Dosage Form + Strength Cardilet 300mg Tablet
Irbesartan…300mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Accord tablet by CCL
DML to the firm.
Brand Name +Dosage Form + Strength Ketowin 10mg Tablet
Ketorolac Tromethamine…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antiinflammatory And Antirheumatic Products, Non-Steroids
Type of Form Form 5
Me-too status Toradol Tablet by Martin Dow
DML to the firm.
Brand Name +Dosage Form + Strength Luflet 10mg Tablet
Leflunomide…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Selective immunosuppressants (L04AA)
Type of Form Form 5
Me-too status Leflomid Tablet by Pharmatec
DML to the firm.
Leflunomide…20mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
Leflunomide…100mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
Brand Name +Dosage Form + Strength Vinlevo 125mg/5ml Syrup
Levofloxacin…125mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
 Evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) as liquid syrup / solution alongwith
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 + Strength Vinlevo 250mg/10ml Syrup
Levofloxacin…250mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
(generic / me-too status) as liquid syrup / solution alongwith
 Firm have applied for Levofloxacin 125mg/5ml Syrup as well as
Levofloxacin 250mg/10ml Syrup. Firm submitted that this
application is 250mg/5ml (250/10ml is written mistakenly).
However in USFDA only 250mg/10ml strength is available.
 Evidence of applied formulation/drug (Levofloxacin 250mg/5ml Syrup) already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm
 Evidence of approval of applied formulation (Levofloxacin 250mg/5ml Syrup) in reference
regulatory authorities/agencies which were adopted by the Registration Board in its 275 th meeting.
 Submission of full fee of registration for correction in composition / label claim as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Morid 25mg Tablet
Levosulpiride…25mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antipsychotic
Type of Form Form 5
Approval status of product in AIFA Italy approved.
Me-too status Levide tablet by Swiss Pharma
DML to the firm.
Brand Name +Dosage Form + Strength Morid 50mg Tablet
Levosulpiride…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in AIFA Italy approved.
Me-too status Levide tablet by Swiss Pharma
DML to the firm.
Brand Name +Dosage Form + Strength Linac 145mcg Capsule
Linaclotide…145mcg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other drugs for constipation
Type of Form Form 5
Approval status of product in LINZESS® 145mcg (linaclotide LINZESS contains linaclotide-
Reference Regulatory Authorities. coated beads in hard gelatin capsules.) capsules, USFDA approved.
Me-too status
DML to the firm.
 Reference product contains linaclotide-coated beads in hard gelatin
capsules while your applied formulation does not depict use of
coated beads. Justification is required in this regard.
 Provide source of linaclotide-coated along with COA, stability
study data of 3 batches of pellets, GMP certificate of pellets
manufacturer and differential fee (in case of imported beads).
(generic / me-too status) alongwith registration number, brand
name and name of firm.
 Submission of stability study data of three batches as per the
guidelines and checklist approved by Registration Board in its 293 rd
meeting.
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 of
three batches as per the guidelines and checklist approved by Registration Board in its 293 rd meeting within
6 months..
Brand Name +Dosage Form + Strength Sino-H 20/25 mg Tablet
Lisinopril As Dihydrate…20mg
Hydrochlorothiazide…25mg
PKR 20,000/-: 06-03-2019
Pharmacological Group ACE inhibitors & Diuretics
Type of Form Form 5
Me-too status Co-Ziscar 20/25mg Tablets by Tabros pharma
DML to the firm.
 Firm has revise formulation from film coated to uncoated tablet as
per reference product without submission of 7,500/- fee.
conducted within last three years along with Rs. 7,500/- fee for revision of formulation from film coated
tablet to uncoated tablet as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Montin 10mg Tablet
Memantine HCl…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Afdol Tablet by AGP
DML to the firm.
Brand Name +Dosage Form + Strength Montin 10mg/5ml Syrup
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in NAMENDA 2 mg/mL Oral Solution (USFDA Approved)
Me-too status Stanza Syrup by Rotex Pharma
DML to the firm.
Each 5ml Contains:
Memantine as HCl…10mg
Each 5ml Contains:
Memantine as HCl…10mg
within last three years along with Rs. 30,000/- fee for correction in salt form as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Respiz 5mg Tablet
Composition Each Chewable Tablet Contains:
Montelukast As Sodium…5mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Leukotriene receptor antagonists
Type of Form Form 5
Me-too status Respicare Chewable Tablet by Genix
DML to the firm.
Brand Name +Dosage Form + Strength Nobilet 2.5mg Tablet
Nebivolol As HCl…2.5mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Beta blocking agents, selective
Type of Form Form 5
Me-too status Nebil Tablet by Getz
DML to the firm.
Brand Name +Dosage Form + Strength Nobilet 10mg Tablet
Nebivolol As HCl…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Beta blocking agents, selective
Type of Form Form 5
Me-too status Nebil Tablet by Getz
DML to the firm.
Brand Name +Dosage Form + Strength Nimolet 30mg Tablet
Nimodipine…30mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Calcium channel blocker
Type of Form Form 5
Me-too status Nidopin Tablet by Global
DML to the firm.
Brand Name +Dosage Form + Strength Vasolex 800mg Tablet
Piracetam…800mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Nootropics
Type of Form Form 5
Me-too status Nootropil Tablet by M/s GSK
DML to the firm.
Brand Name +Dosage Form + Strength Roexi 20mg Tablet
Composition Each Dispersible Tablet Contains:
Piroxicam Betacyclodextrin Eq. To Piroxicam…20mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in MOBILIS D-20 piroxicam 20mg dispersible tablet blister pack TGA
Reference Regulatory Authorities. Australia Approved
Me-too status Pcam dispersible tablet by Martin Dow
DML to the firm.
authorities/agencies which were adopted by the Registration Board
in its 275th meeting, since the reference product approved in TGA
Australia is available as Piroxicam instead of Piroxicam
Betacyclodextrin.
Decision: Deferred for evidence of approval of applied formulation in reference regulatory authorities /
Brand Name +Dosage Form + Strength Potcit 10mEq Tablet
Potassium Citrate…10mEq
PKR 20,000/-: 06-03-2019
Pharmacological Group Mineral Supplements
Type of Form Form 5
Me-too status Lithocit Tablet by Getz
DML to the firm.
Brand Name +Dosage Form + Strength Sital 50mg Tablet
Sitagliptin Phosphate Monohydrate Eq. To Sitagliptin…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Tagip tablets by Highnoon
DML to the firm.
Brand Name +Dosage Form + Strength Sital 100mg Tablet
Sitagliptin Phosphate Monohydrate Eq. To Sitagliptin…100mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Tagip tablets by Highnoon
DML to the firm.
Brand Name +Dosage Form + Strength Terifit 125mg Tablet
Terbinafine As HCl…125mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
Brand Name +Dosage Form + Strength Terifit 250mg Tablet
Terbinafine As HCl…250mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
DML to the firm.
Brand Name +Dosage Form + Strength Thiocol 4mg Tablet
Thiocolchicoside…4mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in ANSM France Approved
Me-too status Myolax tablet by Genetics
DML to the firm.
Brand Name +Dosage Form + Strength T-Zin 4mg Tablet
Tizanidine As HCl…4mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Movax Tablet by Sami
DML to the firm.
849.Name and address of manufacturer / M/s Winilton Pharmaceuticals Pvt Ltd.
Applicant Plot # 45, Street # S-5, National Industrial Zone, Rawat,
Islamabad
Brand Name +Dosage Form + Strength Winzor 5/20mg Tablet
PKR 20,000/-: 06-03-2019
blockers
Type of Form Form 5
GMP status Firm has submitted copy of inspection report dated 07-03-2019
in which the panel recommends the renewal of DML for
following section:
 Tablet (General) Section,
 Tablet (Antibiotic) section
 Capsule (General) section
Firm has also submitted copy of letter for issuance of GMP
certificate to QA&LT Division DRAP dated 13-04-2022.
monograph is available in latest edition of USP. Firm has now
revised specifications to USP but NOT submitted any fee for
revision of specifications.
Islamabad
Brand Name +Dosage Form + Strength Winzor 10/20mg Tablet
Olmesartan Medoximil…20mg
PKR 20,000/-: 06-03-2019
blockers
Type of Form Form 5
following section:
Islamabad
Brand Name +Dosage Form + Strength Wareon 40/80/125mg Capsule
Aprepitant…40mg
Aprepitant…80mg
Aprepitant…125mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other antiemetics
Type of Form Form 5
Approval status of product in US FDA approved
Me-too status Apritus 125mg Capsule of M/s S.J&G Karachi (Reg.# 074887)
following section:
Remarks of the Evaluator3.  We applied for registration of WAREON (Aprepitant) 40, 80 and
125mg on 7 March 2017. Keeping in view of the international/local
availability of products in separate packing of each strength, it is
humbly requested to please consider our dossier as WAREON
(Aprepitant) 125mg Capsule. Revised Form 5 is provided by the
firm.
 Firm has not submitted fee for revision of formulation
Aprepitant…125mg
 Firm will submit 30,000/- fee for revision of formulation as per notification No.F.7-11/2012-
Islamabad
Brand Name +Dosage Form + Strength Piprawin 10mg Tablet
Aripiprazole…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Aripaze Tablet by Global
following section:
Islamabad
Brand Name +Dosage Form + Strength Piprawin 15mg Tablet
Aripiprazole…15mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Arizole Tablet by Amarant
following section:
Islamabad
Brand Name +Dosage Form + Strength Winsatra 10mg Capsule
Atomoxetine (as hydrochloride)…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Centrally acting sympathomimetics
Type of Form Form 5
Me-too status Moxetin Capsule by Genix
following section:
Remarks of the Evaluator3.  Firm has revised the label claim and added the salt form as
hydrochloride. However, firm has NOT submitted full fee of
registration for revision of salt form and composition.
Islamabad
Brand Name +Dosage Form + Strength Winsatra 25mg Capsule
Atomoxetine (as hydrochloride)…25mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Moxetin Capsule by Genix
following section:
Remarks of the Evaluator3.  Firm has revised the label claim and added the salt form as
hydrochloride. However, firm has NOT submitted full fee of
registration for revision of salt form and composition.
Islamabad
Brand Name +Dosage Form + Strength Baclowin 10mg Tablet
Baclofen…10mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form 5
Me-too status Baclofa Tablet by Helix
following section:
Islamabad
Brand Name +Dosage Form + Strength Benza 10mg Tablet
Cyclobenzaprine HCl…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in FLEXERIL (5mg, 10mg) film coated tablets USFDA Approved and
Reference Regulatory Authorities. Discontinued with reason that “Federal Register determination that
product was not discontinued or withdrawn for safety or efficacy
reasons”
Me-too status Cybem Tablet by Sami Pharma
following section:
Islamabad
Brand Name +Dosage Form + Strength Destine 5mg Tablet
Desloratadine…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Destina Tablet by Hilton
following section:
Remarks of the Evaluator3.  Firm has revision the formulation from uncoated to film coated
tablet as per reference product. However, firm has NOT submitted
fee for this revision.
Decision: Approved.
 Firm will submit 7,500/- fee for revision of formulation from uncoated to film coated tablet as
per reference product as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Islamabad
Brand Name +Dosage Form + Strength Dexiwin 400mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
Islamabad
Brand Name +Dosage Form + Strength Dulexa 30mg Capsule
Duloxetine HCl (as enteric coated pellets) eq to Duloxetine….30mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
Remarks of the Evaluator3. Source of pellets: M/s Vision Pharmaceuticals.
 Firm has revise the label claim for correction of salt form as per
reference product but has NOT submitted full fee of registration for
this revision.
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Dulexa 60mg Capsule
Duloxetine HCl (as enteric coated pellets) eq to Duloxetine
……60mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
Remarks of the Evaluator3. Source of pellets: M/s Vision Pharmaceuticals.
 Firm has revise the label claim for correction of salt form as per
reference product but has NOT submitted full fee of registration for
this revision.
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Eprewin 50mg Tablet
Eperisone HCl…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in Eperisone Hydrochloride Tablets 50mg "TCK" PMDA Japan
Reference Regulatory Authorities. Approved (Sugar coated tablet)
Me-too status Eprisa Tablet by Fynk Pharma
following section:
Remarks of the Evaluator3.  Evidence of approval of applied formulation as film coated tablet in
reference regulatory authorities/agencies which were adopted by
the Registration Board in its 275th meeting, since the reference
product approved by PMDA Japan is as sugar coated tablet.
Each Sugar Coated Tablet Contains:
Eperisone HCl…50mg
 Firm will submit 30,000/- fee for revision of formulation as per notification No.F.7-11/2012-
Islamabad
Brand Name +Dosage Form + Strength Etroxib 60mg Tablet
Etoricoxib…60mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antiinflammatory and Antirheumatic Products, Non-Steroids
Type of Form Form 5
Me-too status Hetoxib Tablet by Hilton
following section:
Islamabad
Brand Name +Dosage Form + Strength Fexowin 120mg Tablet
Fexofenadine HCl…120mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Fexet Tablets by Getz
following section:
Islamabad
Brand Name +Dosage Form + Strength Fexowin 180mg Tablet
Fexofenadine Hcl…180mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Fexet Tablets by Getz
following section:
Islamabad
Brand Name +Dosage Form + Strength Iband 150mg Tablet
Ibandronic acid (as sodium monohydrate) …150mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Ibnate Tablets by Geniz Pharma
following section:
Remarks of the Evaluator3.  Latest GMP inspection report conducted within a period of last
three years.
 Reference of finished product specifications.
 Firm has revised the label claim along with salt form correction.
However, firm has NOT submitted full fee for this revision.
Decision: Approved with Innovator’s specification.
Islamabad
Brand Name +Dosage Form + Strength Ketozole 200mg Tablet
Ketoconazole…200mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Imidazole derivatives
Type of Form Form 5
Me-too status Danzap Tablet by Hilton
following section:
Islamabad
Brand Name +Dosage Form + Strength Wincam 8mg Tablet
Lornoxicam…8mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Reference Regulatory Authorities. approved.
Me-too status Zafon Tablets by Getz
following section:
Islamabad
Brand Name +Dosage Form + Strength Mentine 10mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Afdol Tablet by AGP
following section:
Islamabad
Brand Name +Dosage Form + Strength Naproflex Plus 500/85mg Tablet
Naproxen Sodium…500mg
Sumatriptan As Succinate…85mg
PKR 20,000/-: 06-03-2019
Pharmacological Group NSAID and Selective serotonin (5HT1) agonists
Type of Form Form 5
Me-too status Sumanex Tablet by High-Q
following section:
Islamabad
Brand Name +Dosage Form + Strength Setwin 8mg tablet
Ondansetron (as hydrochloride Dihydrate)…8mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antiemetic
Type of Form Form 5
Me-too status Danset Tablet by CCL
following section:
Remarks of the Evaluator3.  Firm has revised the label claim along with salt form correction.
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Oxitine 37.5mg Tablet
Composition Each enteric, film coated, controlled release tablet contains:
Paroxetine (as HCl)…37.5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Seroxat CR Tablet by GSK
following section:
Remarks of the Evaluator3.  Firm has initially applied for film coated tablet later the firm
revised its formulation to enteric film coated controlled release
tablet. Firm has NOT submitted full fee for this revision.
Decision: Approved.
 Firm will submit 7,500/- fee for revision of formulation from film coated tablet to enteric film
coated controlled release tablet as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Islamabad
Brand Name +Dosage Form + Strength Winquit 100mg Tablet
Quetiapine As Fumarate…100mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Q-Par Tablet by Helix
following section:
Islamabad
Brand Name +Dosage Form + Strength Winquit 200mg Tablet
Quetiapine As Fumarate…200mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Q-Par Tablet by Helix
following section:
Islamabad
Brand Name +Dosage Form + Strength Freetime 50mg Tablet
Sertraline (as hydrochloride) …50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Seralin Tablet by Bosch
following section:
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Freetime 100mg Tablet
Sertraline (as hydrochloride) …100mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Seralin Tablet by Bosch
following section:
Decision: Approved.
Islamabad
Brand Name +Dosage Form + Strength Wisamet 50/500mg Tablet
Sitagliptin As Phospate Monohydrate…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
Islamabad
Brand Name +Dosage Form + Strength Wisamet 50/1000mg Tablet
Metformin Hcl…1000mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
Islamabad
Brand Name +Dosage Form + Strength Winafin 125mg Tablet
Tarbinafine (as HCl)…125mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in Lamisil Tablet (TGA Approved)
Me-too status TBF Tablet by Rotex Pharma
following section:
Islamabad
Brand Name +Dosage Form + Strength Winafin 250mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in TGA Approved
Me-too status TBF Tablet by Rotex Pharma
following section:
Islamabad
Brand Name +Dosage Form + Strength Widamet 50/500mg Tablet
Vildagliptin…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Galmet Tablet by Vision Pharma
following section:
Decision: Approved with Innovator’s specifications with a shelf life of 18 months. Registration letter will
be issued after submission of latest GMP inspection report conducted within last three years.
Islamabad
Vildagliptin…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
Applicant
Plot # 45, Street # S-5, National Industrial Zone, Rawat,
Islamabad
Vildagliptin…50mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
following section:
884.Name and address of manufacturer / M/s Rotex Pharma Pvt Ltd.
Applicant Plot No. 206 & 207. Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Ossorin-D Tablet
Vitamin D… 400 IU
Ossein Mineral Complex…830mg Corresponding to
Calcium…177.6mg
Phosphorus…82.2mg
Residual Mineral Salts…24.8mg
Collagen…224mg
Other Proteins…88.4mg
Trace Elements… Fi,mg,Fe,Zn,Cu,Ni. Corresponding To
Approximately 440mg Hydroxyapatite
PKR 20,000/-: 07-03-2019
Pharmacological Group Minerals / Vitamin
Type of Form Form 5
Finished Product Specification Firm has claimed in house specification
Me-too status Osnate-D Tablets by AGP
GMP status GMP certificate issued on the basis of inspection dated
12.08.2020
1. Evidence of approval of applied Firm submitted that Registration Board already
formulation in reference regulatory approved the formulation in DRB meeting No. M-
authorities/agencies which were adopted 295 without any availability of RRA reference for
by the Registration Board in its 275th Hilton Pharma Karachi.
meeting.
2. Evidence of atomic absorption Firm has submitted copy of letter dated 27-08-2020
spectrophotometer used for the analysis of from Rotex Pharma specifying that they have
drug product. atomic absorption spectrophotometer (Model AA
7000 Brand Shimadzu) available and operating at
our factory premises located at plot No. 206 & 207,
Industrial Triangle Kahuta Road Islamabad. The
letter is verified and signed by FID Islamabad dated
01-09-2020.
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.
885. Name and address of manufacturer / M/s Werrick Pharmaceuticals, 216-217, I-10/3,
Applicant Industrial Area, Islamabad.
Brand Name +Dosage Form + Strength Oxytide-F Dry Powder Inhaler 50/250mcg
Diary No. Date of R& I & fee Diary No: 15332: 15-09-17;
PKR: 20,000/-: 15-09-2017
(Duplicate dossier submitted along with relevant page of
R&I register)
Salmeterol Xinafoate…. 50mcg
Fluticasone propionate….250mcg
Pharmacological Group Long acting beta-2-adrenoreceptor agonists/Corticosteroid
Type of Form Form-5
Finished Product Specification Firm has claimed manufacturer’s Specifications
Pack size & Demanded Price 28‘s, 60‘s ; As per SRO
Approval status of product in Reference ADVAIR DISKUS 250/50 (USFDA Approved)
Regulatory Authorities.
Me-too status Seretide Diskus 50/250mcg of GSK
GMP status GMP certificate of M/s Werrick Pharmaceuticals issued
Remarks of the Evaluator. Each delivered dose contains:
Salmeterol as Xinafoate…………..45mcg
Fluticasone Propionate………231mcg
 The label claim of the applied product is not as per
innovator’s product, since the applied product contains
salmetrol xinafoate while innovator’s product provides
label claim and delivered dose for salmetrol base. Firm
has not revised its claim or submitted any fee.
 Firm has claimed in house specs while USP
mmonograph of applied product is available.
Decision: Approved with USP specifications and with following label claim:
Salmeterol as Xinafoate…. 50mcg
 Registration Board further decided that following label claim of delivered dose shall be
declared on registration letter:
“Each delivered dose contains:
Salmeterol as Xinafoate…………..45mcg
Fluticasone Propionate………231mcg”
 Firm will submit 30,000/- fee for correction in salt form as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
886. Name and address of manufacturer / M/s Wilson's Pharmaceuticals.

Applicant 387-388, I-9, Industrial Area, Islamabad
Brand Name +Dosage Form + Strength Coldene Pro XR Tablet 60/120mg
Composition Each Extended Release Film Coated Tablet Contains:
Pseudoephedrine HCl…120mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Other antihistamines for systemic use - Nasal
decongestant
Type of Form Form 5
Approval status of product in Reference USFDA Approved (Over-the-counter drug) as bilayer tablet
Regulatory Authorities. Telfast Decongestant Tablet (TGA Approved) Bi-layer,
capsule shaped, film coated tablets
Me-too status Telfast D Tablet by Sanofi Aventis
GMP status GMP certificate issued on basis of inspection conducted
on 28-07-2022.
Remarks of the Evaluator3.  Firm has revised the formulation along with submission of
full fee PKR 30,000/- vide slip number 0898320516 dated
23-11-2022. The revised label claim of the firm is as under:
Each bi-layer extended release film coated tablet contains:
Fexofenadine HCl………60mg
Pseudoephedrine HCl…..120mg
 Firm has submitted that the bilayer composition our our
product Teli-H 40/12.5mg Tablet was also approved in 321st
RB meeting.
Brand Name +Dosage Form + Strength Wiscon Suspension 500/213/325mg
Composition Each 10ml Suspension Contains:
Sodium Alginate…500mg
Sodium Bicarbonate…213mg
Calcium Carbonate….325mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Antacid
Type of Form Form 5
Approval status of product in Reference Gaviscon Double Action Aniseed (MHRA Approved)
Me-too status Lagita Double Action Suspension by Sami
on 28-07-2022.
Remarks of the Evaluator3.  Submission of stability study data of three batches as per the
guidelines and checklist approved by Registration Board in
its 293rd meeting. Firm has submitted that stability study
data of the applied product is under stability studies and
they will submit the data as soon as it is complete.
Decision: Deferred for submission of stability study data as per the guidelines provided in 293 rd
Brand Name +Dosage Form + Strength Wiscon Chewable Tablets 200/200/25mg
Aluminium hydroxide Gel (dried)…200mg
Magnesium hydroxide…200mg
Simethicone…….25mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Antacid
Type of Form Form 5
Approval status of product in Reference Maalox Plus Chewable Tablets 200mg/200mg/25mg (HPRA
Regulatory Authorities. Ireland Approved)
Chewable Tablet.
Bi-layered, white/yellow tablets engraved with“Maalox” on
oneside.
Me-too status Trisil plus tablet of Efroze
on 28-07-2022.
Remarks of the Evaluator3.  The HPRA Ireland approved tablet is available as chewable
bilayer tablet while firm has applied for chewable tablet.
Each Chewable bi-layer Tablet Contains:
Aluminium hydroxide Gel (dried)…200mg
Magnesium hydroxide…200mg
Simethicone…….25mg
 Firm will submit 30,000/- fee for revision in formulation as per reference product as per
889. Name and address of manufacturer / M/s Werrick Pahrmaceuticals. 216-217,I-10/3, Industrial
Applicant Area, Islamabad
Brand Name +Dosage Form + Strength Flueze Pro XR Tablet 60/120mg Tablet
Composition Each Extended Release Film Coated Tablet Contains:
Pseudoephedrine HCl…120mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Other antihistamines for systemic use - Nasal
decongestant
Type of Form Form 5
Approval status of product in Reference USFDA Approved (Over-the-counter drug) as bilayer tablet
Regulatory Authorities. Telfast Decongestant Tablet (TGA Approved) Bi-layer,
capsule shaped, film coated tablets
Me-too status Telfast D Tablet by Sanofi Aventis
on 12-8-2022
Remarks of the Evaluator3.  Reference of finished product specifications.
 Reference product is available as a bilayer extended release
film coated tablet, revise your label claim as per the
reference product.
 Evidence of bilayer tablet machine
 Firm will submit 30,000/- fee for revision in formulation as per reference product as per
 Firm will submit evidence of “IQ,OQ & PQ reports of “Bi-layer tablet compression machine”
before issuance of Registration letter.
890. 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 Petronel Injection 1MIU
Composition Each Vial Contains:
Colistimethate Sodium…1MIU
PKR 20,000/-: 06-03-2019
Pharmacological Group Antibacterials for systemic use
Type of Form Form 5
Approval status of product in Reference MHRA Approved
Me-too status Colimixin Injection by Genix Pharma
GMP status Firm has submitted copy of GMP inspection report dated
13-09-2022 and 14-09-2022 ehich concludes that the
firm is operating at Good level of GMP compliance.
Remarks of the Evaluator3.  Firm has submitted copy of letter of grant of additional
section specifying Dry powder injection (General) section.
Decision: Approved. Firm will revise the label claim as per the decision taken by the Board in instant
meeting regarding “Review of Colistimethate for Injection” along with submission of requisite fee for
B&A/DRAP dated 07.05.2021 and 13.07.2021.
Lahore
Brand Name +Dosage Form + Strength Zune 20mg capsule
Composition Each Delayed Release Capsule Contains:
Esomeprazole As Magnesium Trihydrate…20mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Nexum capsule by Getz
Remarks of the Evaluator3.  Source of pellets: M/s Vision Pharmaceuticals, Islamabad.
 Firm has revised the label claim as per the following along
with submission of Fee PKR 7,500/-. The revised label
claim is as under:
Esomeprazole as Magnesium Trihydrate (enteric coated
pellets)…20mg

Esomeprazole as Magnesium Trihydrate (enteric coated pellets)…20mg
 Firm will submit 22,500/- balance fee for revision in formulation as per reference product as
Lahore
Brand Name +Dosage Form + Strength Zune 40mg Capsule
Esomeprazole As Magnesium Trihydrate…40mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
claim is as under:
Esomeprazole as Magnesium Trihydrate (enteric coated
pellets)…40mg

Esomeprazole as Magnesium Trihydrate (enteric coated pellets)…40mg
Lahore
Brand Name +Dosage Form + Strength Aidra 10mg Tablet
Leflunomide…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Decision: Approved.
Lahore
Brand Name +Dosage Form + Strength Lavitam 250mg Tablet
Levetiracetam…250mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Lumark Tablet by Searle
Decision: Approved.
Lahore
Brand Name +Dosage Form + Strength Lavitam 500mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Lumark Tablet by Searle
Decision: Approved.
Lahore
Brand Name +Dosage Form + Strength Lavitam Injection 500mg/5ml
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Approval status of product in Reference Levetiracetam 100 mg / mL Concentrate for solution for
Regulatory Authorities. infusion (MHRA Approved)
Me-too status Lumark Injection by Searle
Remarks of the Evaluator3.  Firm has submitted copy of letter of grant of additional
section specifying Liquid injection (General) section.
Lahore
Brand Name +Dosage Form + Strength Ambron Tablet 400mg
Composition Each Delayed Release Tablet Contains:
Mesalamine…400mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Aminosalicylic acid and similar agents
Type of Form Form 5
Me-too status Colinil Tablet by Novamed
Lahore
Brand Name +Dosage Form + Strength Benzim Tablet 20mg
Composition Each Delayed Release Tablet Contains:
Omeprazole…20mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Zulcid Tablet by Shrooq
Decision: Deferred for evidence of availability of requisite manufacturing facilities/technology in line
with reference product for multiple unit pllets system (MUPS).
Lahore
Brand Name +Dosage Form + Strength Benzim capsule 40mg
Omeprazole…40mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
claim is as under:
Omeprazole (as enteric coated pellets)…40mg

Omeprazole (as enteric coated pellets)…40mg
900. 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 Vastdip 5/10 mg Tablet
Atorvastatin As Calcium Trihydrate…10mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Antihypertensive
Type of Form Form 5
Approval status of product in Reference USFDA Approved.
Me-too status Lipifal Tablet by Helix
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
Remarks of the Evaluator3.  Latest GMP inspection report conducted within a period of
last three years.
 Revision of formulation to film coated tablet as per the
reference product along with submission of applicable fee.
Decision: Approved.
 Firm will revise the formulation as per innovator’s product along with submission of
requisite fee as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name +Dosage Form + Strength Vastdip 10/10 mg Tablet
Atorvastatin As Calcium Trihydrate…10mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Approval status of product in Reference USFDA Approved.
Me-too status Lipifal Tablet by Helix
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Amsoar 5/80 mg Tablet
Valsartan…80mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Exforge Tablet by Novartis
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Amosar 5/160 mg Tablet
Amlodipine Besylate…5mg
Valsartan…160mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Amsoar 10/160 mg Tablet
Valsartan…160mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Clofen 10mg Tablet
Baclofen…10mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Muscle relaxants, centrally acting agents
Type of Form Form 5
Approval status of product in Reference USFDA Approved
Me-too status Baclofa Tablet by Helix
last three years.
Decision: Approved. Registration letter will be issued after submission of latest GMP inspection
Brand Name +Dosage Form + Strength Sloradin 5mg Tablet
Desloratadine…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Destina Tablet by Hilton
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Stin 10mg Tablet
Ebastine…10mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Approval status of product in Reference Netherland Approved.
Me-too status Kestine Tablet by Highnoon
last three years.
 You have applied in house specifications while the product
monograph is available in JP. Revise your specifications
Decision: Approved with JP specifications.
Brand Name +Dosage Form + Strength Talopra 5mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Talopra 10mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Zepa-Mark 1mg Tablet
Lorazepam…1mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Lorapram tablet by Hiranis
last three years.
 Evidence of approval of psychotropic tablet section from
Licensing Division DRAP.
Decision: Deferred for confirmation of required manufacturing facility / section from Licensing
Division.
Brand Name +Dosage Form + Strength Zepa-Mark 2mg Tablet
Lorazepam…2mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Lorapram tablet by Hiranis
last three years.
Division.
Brand Name +Dosage Form + Strength Losat-P 25mg Tablet
Losartan Potassium…25mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Xavor Tablet by Ferozesons
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Losat-P 50mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Xavor Tablet by Ferozesons
last three years.
Decision: Approved.
Brand Name +Dosage Form + Strength Mecoman 500mcg Tablet
Mecobalamin…500mcg
PKR 20,000/-: 07-03-2019
Pharmacological Group Vitamin B12 analogue
Type of Form Form 5
Approval status of product in Reference PMDA Japan Approved
Me-too status Methycobal tablet by Hilton
last three years.
 Revision of formulation to sugar coated tablet as per the
 You have applied in house specifications while the product
monograph is available in JP. Revise your specifications
Decision: Approved with JP Specifications.
Brand Name +Dosage Form + Strength Melodem 7.5mg Tablet
Meloxicam…7.5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
last three years.
Brand Name +Dosage Form + Strength Melodem 15mg Tablet
Meloxicam…15mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
last three years.
Brand Name +Dosage Form + Strength Phenidate 10mg Tablet
Methylphenidate HCl…10mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Ritalin Tablet by Novartis
last three years.
Division.
Brand Name +Dosage Form + Strength Moximed 400mg Tablet
Moxifloxacin Hcl…400mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Avelox Tablet by Bayer
last three years.
 Revision of formulation as per the reference product along
with submission of full fee. The revised label claim shall be
“Each film coated tablet contains:
Moxifloxacin as hydrochloride….400 mg”
Decision: Approved.
c. New cases in which stability study data is required
919. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals.

Applicant Plot # 122, Block A, Phase V, Hattar Industrial Estate,
Hattar
Brand Name +Dosage Form + Strength Denset 2mg Tablet
Composition Each Uncoated Tablet Contains:
Dienogest…2mg
PKR 20,000/-: 07-03-2019
Pharmacological Group Progestogens
Type of Form Form 5
Finished Product Specification
Approval status of product in Reference
Me-too status
GMP status
Remarks of the Evaluator3.  Evidence of approval of applied formulation in reference
regulatory authorities/agencies which were adopted by the
 Evidence of applied formulation/drug already approved by
DRAP (generic / me-too status) alongwith registration
number, brand name and name of firm.
 Evidence of requisite manufacturing facility / section
approval from Licensing Division.
which were adopted by the Registration Board in its 275th meeting.
alongwith registration number, brand name and name of firm or else application on Form 5-
D along with submission of differential fee and stability study data as per the guidelines
provided in 293rd meeting of Registration Board.
 Evidence of requisite manufacturing facility / section approval from Licensing Division.
920. Name and address of manufacturer / M/s Winlet Pharmaceuticals.
Brand Name +Dosage Form + Strength Sofvel 400/100 mg Tablet
Sofosbuvir…400mg
Velpatasvir…100mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Antivirals for treatment of HCV infections
Type of Form Form 5
Me-too status Fosbu V Tablet by Highnoon
GMP status
1. Submission of stability study data of three API material procurement is in progress
batches as per the guidelines and checklist
approved by Registration Board in its 293 rd
meeting.
2. Latest GMP inspection report conducted Inspection report will be submitted within 1
within a period of last three years. month.
Brand Name +Dosage Form + Strength Dapazin 10mg Tablet
Dapagliflozin…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Daploz Tablet by Highnoon
GMP status
1. Submission of stability study data of three Three batches data submitted to DRAP
meeting.
3. Revise your label claim as per the Stability has been conducted as per the
reference product along with submission of reference product (Forxiga 10mg Tablet)
requisite fee.
Minutes of 323 meeting of Registration Board (6th to 8th December, 2022)
rd 721
 Revision of the formulation as per innovator’s product along with submission of requisite fee
 Stability study data as per the guidelines provided in 293 rd meeting of Registration Board.
Brand Name +Dosage Form + Strength Canazin 300mg Tablet
Canagliflozin…300mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Glucana Tablet by CCL
GMP status
meeting.
Brand Name +Dosage Form + Strength Canazin-M 150/500 mg Tablet
Canagliflozin…150mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status CGZin M Tablet by Helix
GMP status
meeting.
Brand Name +Dosage Form + Strength Azitan 80mg Tablet
Azilsartan Medoxomil Potassium Eq. To Azilsartan
Medoxomil As Potassium…80mg
PKR 20,000/-: 06-03-2019
Minutes of 323 meeting of Registration Board (6 to 8th December, 2022)
rd th 722
Type of Form Form 5
Me-too status N/A
GMP status
meeting.
3. Evidence of applied formulation/drug No response submitted by the firm
already approved by DRAP (generic / me-
too status) along with registration number,
4. Application on Form 5D along with No response submitted by the firm
differential fee
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 application on
Form 5-D along with submission of differential fee and stability study data as per the guidelines
Brand Name +Dosage Form + Strength Azitan-C 40/25 mg Tablet
Azilsartan Medoxomil Potassium Eq. To Azilsartan
Medoxomil As Potassium…40mg
Chlorthalidone…25mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status N/A
GMP status

meeting.
3. Evidence of applied formulation/drug No response submitted by the firm
too status) along with registration number,
4. Application on Form 5D along with Application is already submitted on Form
differential fee 5D, differential fee will be submitted soon.
926. Name and address of manufacturer / M/s Winilton Pharmaceuticals Pvt Ltd.
Islamabad
Brand Name +Dosage Form + Strength Hepwin 400/100mg Tablet
Sofosbuvir…100mg
Valpatasvir…400mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Fosbu V Tablet by Highnoon
GMP status
its 293rd meeting.
 Latest GMP inspection report conducted within a period of
last three years.
Decision: Deferred for submission of stability study data as per the guidelines provided in 293rd
927. Name and address of manufacturer / M/s Wenovo Pharmaceuticals.
Applicant Plot # 31& 32 Punjab Small Industrial Estate Taxila
Pakistan
Brand Name +Dosage Form + Strength Zenwo 5mg Tablet
Dapagliflozin As Propanediol Monohydrate…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status Last Inspection Report dated 15-06-2022, panel
concludes that the firm is operating at good level of
GMP compliance.
its 293rd meeting.
last three years.
Pakistan
Brand Name +Dosage Form + Strength Zenwo 10mg Tablet
Dapagliflozin As Propanediol Monohydrate…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP compliance.
its 293rd meeting.
last three years.
929. Name and address of manufacturer / M/s Vision Pharmaceuticals.
Applicant Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Kalset 30mg Tablet
Cinacalcet Hcl Eq To Cinacalcet…30mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other anti-parathyroid agents
Type of Form Form 5
Me-too status Mimcipar Tablet by Genome
GMP status
its 293rd meeting.
last three years.
 Revise your label claim to film coated tablet as per the
reference product along with submission of requisite fee.
930. Name and address of manufacturer / M/s Vision Pharmaceuticals.
Applicant Plot # 22,23, Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Kalset 60mg Tablet
Cinacalcet Hcl Eq To Cinacalcet…60mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Other anti-parathyroid agents
Type of Form Form 5
Me-too status Mimcipar Tablet by Genome
GMP status
its 293rd meeting.
last three years.
 Revise your label claim to film coated tablet as per the
reference product along with submission of requisite fee.
931. Name and address of manufacturer / M/s Rakaposhi Pharmaceuticals Pvt Ltd.
Applicant 97-K, Industrial Estate, Hayatabad, Peshawar, Pakistan
Brand Name +Dosage Form + Strength Raflozin Tablets 5mg
Dapagliflozin Propanediol …5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
 Revise your label claim as per the reference product along
 You have mentioned Dapagliflozin Propanediol alone as
API in the label claim, while also mentioned metformin in
some sections. Clarify about the exact formulation applied
in this application.
932. Name and address of manufacturer / M/s Rakaposhi Pharmaceuticals Pvt Ltd.
Applicant 97-K, Industrial Estate, Hayatabad, Peshawar, Pakistan
Brand Name +Dosage Form + Strength Raflozin Tablets 10mg
Dapagliflozin Propanediol …10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
 You have mentioned Dapagliflozin Propanediol alone as
API in the label claim, while also mentioned metformin in
some sections. Clarify about the exact formulation applied
in this application.
933. Name and address of manufacturer / M/s Pharmix Laboratories Pvt Ltd.
Applicant 21 Km, Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Obicol 5mg Tablet
Obeticholic Acid…5mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Bile acids and derivatives
Type of Form Form 5
Me-too status Obliva Tablet by Hilton
GMP status Firm has submitted copy of GMP certificate issued on
27-07-2021 based on inspection dated 26-05-2021 and
07-07-2021.
1. Submission of stability study data of three Firm has submitted an undertaking that
batches as per the guidelines and checklist they will submit the stability data before
approved by Registration Board in its 293rd manufacturing any commercial batch and
meeting. will not sale before submission of stability
data.
Firm has not submitted stability study
data.
2. Latest GMP inspection report conducted within Firm has submitted copy of GMP
a period of last three years. certificate issued on 27-07-2021 based on
inspection dated 26-05-2021 and 07-07-
2021.
934. Name and address of manufacturer / M/s Pharma Lord (Pvt) Ltd.
Applicant 12 KM, Lahore Raod, Layyah, Punjab
Brand Name +Dosage Form + Strength Dpax M 5/850mg Tablet
Dapagliflozin Propanediol Monohydrate Eq To
Dapagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Daplozmet Tablet by Highnoon
GMP status GMP certificate issued based on inspection dated 03-05-
2019.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Dpax M 5/1000mg Tablet
Dapagliflozin Propanediol Monohydrate Eq To
Dapagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Daplozmet Tablet by Highnoon
2019.
its 293rd meeting.
last three years.
936. Name and address of manufacturer / M/s Moringa Pharmaceuticals.
Applicant 35-A, Sunder Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Velpasof 400/100 mg Tablet
Sofosbuvir…400mg
Velpatasvir…100mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status
GMP status The firm is granted GMP certificate based on inspection
Remarks of the Evaluator3.  You have mentioned tablet in the brand name and the label
claim is provided for capsule dosage form. Clarification is
required in this regard.
 Evidence of approval of applied formulation as capsule
dosage form in reference regulatory authorities/agencies
which were adopted by the Registration Board in its 275th
meeting, since you have applied capsule dosage form while
the reference product is available as tablet.
 Evidence of applied formulation/drug as capsule dosage form
already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm
 In case your applied formulation is Tablet, submit stability
study data of three batches as per the guidelines and checklist
approved by Registration Board in its 293rd meeting along
with submission of full fee of registration and revised Form
5.
last three years.
rd 728
Brand Name +Dosage Form + Strength Omamor Tablet 12.5mg
Omarigliptin…12.5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status
5.
last three years.
Brand Name +Dosage Form + Strength Omamor Tablet 25mg
Omarigliptin…25mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status
5.
last three years.
Brand Name +Dosage Form + Strength Tiger 60mg Tablet
Ticagrelor…60mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Platelet aggregation inhibitors
Type of Form Form 5
Me-too status Hitica Tablet by Highnoon
GMP status
approved by Registration Board in its 293rd
meeting.
Brand Name +Dosage Form + Strength Weglor 90mg tablet
Ticagrelor…90mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Platelet aggregation inhibitors
Type of Form Form 5
Me-too status Hitica Tablet by Highnoon
GMP compliance.
its 293rd meeting.
Brand Name +Dosage Form + Strength Cabisar 24/26 mg Tablet
Sacubitril…24mg
Valsartan…26mg
PKR 20,000/-: 06-03-2019
Pharmacological Group Angiotensin II receptor blockers, other combinations
Type of Form Form 5
Me-too status Sacuvia Tablet by Highnoon
GMP status
meeting.
Sacubitril…49mg
Valsartan…51mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
meeting.
Sacubitril…97mg
Valsartan…103mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
meeting.
Brand Name +Dosage Form + Strength Wencuval 24/26 mg Tablet
Sacubitril As Sacubitril Valsartan Sodium Salt
Complex…24.3mg
Valsartan As Sacubitril Valsartan Sodium Salt
Complex…25.7mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP compliance.
its 293rd meeting.
last three years.
Complex…48.6mg
Complex…51.4mg
rd th 732
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP compliance.
its 293rd meeting.
last three years.
Complex…97.2mg
Complex…102.8mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP compliance.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Valbitril Capsule 24/26mg
Sacubitril…24mg
Valsartan…26mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status
Registration Board in its 275th meeting, since you have
applied capsule dosage form while the reference product is
available as tablet.
number, brand name and name of firm
Sacubitril…49mg
Valsartan…51mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status
Sacubitril…97mg
rd th 734
Valsartan…103mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status
950. Name and address of manufacturer / M/s Zeta Pharmaceuticals.
Applicant Plot # 494-A, Sunder Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Zempa M 5/500mg Tablet
Empagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Diajard-M Tablet by Highnoon
GMP status GMP certificate has been submitted on the basis of
evaluation conducted on 25-10-2019
its 293rd meeting.
last three years.
 Revise your label claim as per the reference product to film
coated tablet along with submission of requisite fee.
Brand Name +Dosage Form + Strength Zempa M 12.5/1000mg Tablet
Empagliflozin…12.5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Empazin 10mg Tablet
Empagliflozin…10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Me-too status Diajard Tablet by Highnoon
GMP status
1. Submission of stability study data of three Three batches data submitted to DRAP dated
batches as per the guidelines and checklist 7th July 2022.
rd
approved by Registration Board in its 293
meeting.
Brand Name +Dosage Form + Strength Empazin 25mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
1. Submission of stability study data of three Three batches data submitted to DRAP dated
batches as per the guidelines and checklist 7th July 2022.
rd
approved by Registration Board in its 293
meeting.
Brand Name +Dosage Form + Strength Empazin-M 5/1000 mg Tablet
Empagliflozin…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
1. Submission of stability study data of three Three batches data will be submitted within
batches as per the guidelines and checklist 4 months.
meeting.
3. Evidence of applied formulation/drug Diampa-M Tablets by Getz
brand name and name of firm
Brand Name +Dosage Form + Strength Empazin-M 12.5/1000 mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
rd th 737
GMP status
1. Submission of stability study data of three Three batches data will be submitted within
batches as per the guidelines and checklist 4 months.
meeting.
3. Evidence of applied formulation/drug Diampa-M Tablets by Getz
Pakistan
Brand Name +Dosage Form + Strength Xempo 5/1000 mg Tablet
Empagliflozin…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP compliance.
1. Submission of stability study data of three Stability data already submitted on 08-06-
batches as per the guidelines and checklist 2022
meeting.
2. Evidence of applied formulation/drug Xenglu-Met Tablets by Getz
Pakistan
Brand Name +Dosage Form + Strength Xempo-Wen 12.5/1000 mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP compliance.
1. Submission of stability study data of three Stability data already submitted on 08-06-
batches as per the guidelines and checklist 2022
meeting.
2. Evidence of applied formulation/drug Xenglu-Met Tablets by Getz
958. Name and address of manufacturer / M/s Wellborne Pharmachem & Biologicals.
Applicant Plot No. 51/1, 52/2, Phase I & II, Hattar Industrial Estate,
Hattar, K.P.K
Brand Name +Dosage Form + Strength Wefloz-10 mg Tablet
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
959. Name and address of manufacturer / M/s Valor Pharmaceuticals.
Applicant 124/A Industrial Triangle, Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Valoglif 10mg Tablet
Empagliflozin.…10mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Valoglif 25mg Tablet
Empagliflozin.…25mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Glifmet 5/850mg Tablet
Empagliflozin...5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status
GMP status
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Glifmet 5/1000mg Tablet
Empagliflozin...5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
rd th 740
GMP status
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Glifmet 12.5/500mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
last three years.
966. Name and address of manufacturer / M/s Trigon Pharmaceuticals Pvt Limited.
Applicant 8 km, Thoker Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Diflozin 10mg Tablet
Empagliflozin …10mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status The firm was inspected on 25-03-2019 and Conclusion
of inspection was:
inspection M/s Trigon Pharmaceuticals Pvt Ltd Lahore
was considered to be operating at a satisfactory level of
GMP compliance with refrence to GMP guidelines as
per Dugs Act, 1976 and rules framed there under.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Flomet 5/500mg Tablet
Empagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
of inspection was:
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Flomet 12.5/1000mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
of inspection was:
its 293rd meeting.
last three years.
 Stability study data as per the guidelines provided in 293rd meeting of Registration Board.
Brand Name +Dosage Form + Strength Epax M 5mg/500mg Tablet
Empagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
2019.
its 293rd meeting.
last three years.
Empagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
2019.
its 293rd meeting.
last three years.
Empagliflozin…5mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
2019.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Epax M 12.5mg/500mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
2019.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Epax M 12.5mg/850mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
2019.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Epax-M 12.5/1000 mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
2019.
its 293rd meeting.
last three years.
rd th 746
Brand Name +Dosage Form + Strength Empamor 10mg Capsule
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Brand Name +Dosage Form + Strength Empamor M Capsule 5/500mg
Empagliflozin…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Brand Name +Dosage Form + Strength Empamor M XR Capsule 5/1000mg
Empagliflozin…5mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Brand Name +Dosage Form + Strength Empamor M XR Capsule 12.5/500mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
rd 748
Brand Name +Dosage Form + Strength Empamor M XR Capsule 12.5/1000mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
Brand Name +Dosage Form + Strength Zelanso capsule 30mg
Dexlansoprazole…30mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Razodex Capsule of Getz
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Zelanso capsule 60mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
its 293rd meeting.
last three years.
982. Name and address of manufacturer / M/s Zamko Pharmaceuticals (Pvt) Ltd.
Applicant 641-A Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Dexazole 30mg Capsule
Enteric Coated Pellets Dexlansoprazole Eq To 30mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status Inspection date 13/07/2018, panel recommend grant of
DML
its 293rd meeting.
last three years.
983. Name and address of manufacturer / M/s Zamko Pharmaceuticals (Pvt) Ltd.
Applicant 641-A Sundar Industrial Estate, Lahore
Brand Name +Dosage Form + Strength Dexazole 60mg Capsule
Enteric Coated Pellets Dexlansoprazole Eq To 60mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status Inspection date 13/07/2018, panel recommend grant of
DML
its 293rd meeting.
last three years.
984. 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 Lanso Capsule 30mg
PKR 20,000/-: 28-02-2019
Type of Form Form 5
GMP status Last inspection report dated 31-01-2022 concludes that
the overall GMP compliance level is rated as good.
1. Submission of stability study data of three Firm has submitted stability data sheet only. No
batches as per the guidelines and other data as per the checklist approved by the
checklist approved by Registration Board Board in 293rd meeting is submitted.
in its 293rd meeting.
2. Revise your label claim as per the Firm has submitted revised form 5 however the
reference product along with submission submitted label claim is still not as per the
of requisite fee. innovator’s product. Furthermore no fee for
revision of label claim is submitted.
Islamabad
Brand Name +Dosage Form + Strength Wexcillant 30mg Capsule
Dexlansoprazole Enteric Coated…30mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status GMP certificate issued on 15-07-2019 on the basis of
its 293rd meeting.
last three years.
Islamabad
Brand Name +Dosage Form + Strength Wexcillant 60mg Capsule
Dexlansoprazole Enteric Coated…60mg
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status GMP certificate issued on 15-07-2019 on the basis of
its 293rd meeting.
last three years.
987. Name and address of manufacturer / M/s Webrose Pharmaceuticals.
Applicant Plot # 1, Street # 10, National Industrial Zone, Rawat,
Pakistan
Brand Name +Dosage Form + Strength Reaktif 30mg Capsule
Enteric Coated Pellets Of Dexlansoprazole Eq. To
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
 Copy of valid Drug Manufacturing License (DML) along
with evidence of Capsule (General) Section approved by
last three years.
988. Name and address of manufacturer / M/s Webrose Pharmaceuticals.
Applicant Plot # 1, Street # 10, National Industrial Zone, Rawat,
Pakistan
Brand Name +Dosage Form + Strength Reaktif 60mg Capsule
Enteric Coated Pellets Of Dexlansoprazole Eq. To
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status
its 293rd meeting.
 Copy of valid Drug Manufacturing License (DML) along
with evidence of Capsule (General) Section approved by
last three years.
989. Name and address of manufacturer / M/s Searle IV Solutions Pvt Ltd.
Applicant 1.5 km, Manga Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Dexlans 30mg Capsule
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status DML renewal inspection conducted on 02.03.2021 and
renewed the DML up to 2025
its 293rd meeting.
last three years.
990. Name and address of manufacturer / M/s Searle IV Solutions Pvt Ltd.
Applicant 1.5 km, Manga Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Dexlans 60mg Capsule
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status DML renewal inspection conducted on 02.03.2021 and
renewed the DML up to 2025
its 293rd meeting.
last three years.
991. Name and address of manufacturer / M/s Panacea Pharmaceuticals.
Applicant Plot. No. 4, Street No. S-6, National Industrial zone Rawat,
Islamabad
Brand Name +Dosage Form + Strength Dexsole 30mg Capsule
Dexlansoprazole Dual Delayed Release Pellets Eq. To
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status GMP certificate issued dated 20th October,2020
its 293rd meeting.
last three years.
992. Name and address of manufacturer / M/s Panacea Pharmaceuticals.
Applicant Plot. No. 4, Street No. S-6, National Industrial zone Rawat,
Islamabad
Brand Name +Dosage Form + Strength Dexsole 60mg Capsule
Dexlansoprazole Dual Delayed Release Pellets Eq. To
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status GMP certificate issued dated 20th October,2020
its 293rd meeting.
last three years.
993. Name and address of manufacturer / M/s Moon Pharmaceuticals
Islamabad
Brand Name +Dosage Form + Strength D Lanso 30mg Capsule
Dexlansoprazole As Enteric Coated Pellets Eq To
PKR 20,000/-: 07-03-2019
Type of Form Form 5
GMP status Copy of inspection report dated 11-12-2019 wherein the
firm is operating at an acceptable level of GMP.
its 293rd meeting.
last three years.
994. Name and address of manufacturer / M/s Medisearch Pharmacal Pvt Ltd
Applicant 5-Km, Raiwind Manga Road, Lahore
Brand Name +Dosage Form + Strength Dexlan Capsule 30mg
PKR 20,000/-: 07-03-2019
Type of Form Form 5
its 293rd meeting.
last three years.
995. Name and address of manufacturer / M/s Medisave Pharmaceuticals.
Applicant Plot 578-579, Sundar Industrial Estate, Lahore, Pakistan
Brand Name +Dosage Form + Strength Dexisave 60mg capsule
Dexlansoprazole Dual Delayed Release Pellets Eq To
PKR 20,000/-: 06-03-2019
Type of Form Form 5
GMP status GMP certificate issued to M/s Medisave
Pharmaceuticals
dated 01-10-2021 based on inspection conducted on 18-
09-2021.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Empazon 10mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Diampa Tablet by Getz
Pharmaceuticals
09-2021.
its 293rd meeting.
last three years.
Brand Name +Dosage Form + Strength Empazon 25mg Tablet
PKR 20,000/-: 07-03-2019
Type of Form Form 5
Me-too status Diampa Tablet by Getz
Pharmaceuticals
09-2021.
its 293rd meeting.
last three years.
d. Deferred cases
Brand Name +Dosage Form + Strength BUD-AIR Dry Powder Inhaler 100/6mcg
Diary No. Date of R& I & fee Diary No: 15336: 15-09-17; Rs: 20,000/-
Composition Each Rota capsule contains:
Budesonide…. 100mcg
Formoterol fumarate….6mcg
Type of Form Form-5
Finished Product Specification USP Specifications
Pack size & Demanded Price 30‘s; As per SRO
Approval status of product in Reference Approved in Canada (MHRA)
Me-too status Venticort Rotacaps 100mcg+6mcg Capsule of Macter Intr.
GMP status As recorded for above application
Remarks of the Evaluator. Reference product is powder for inhalation which is
different from applied formulation i.e. Rota cap for
inhalation..
th
Registration Board decided to defer the case for further deliberation.
Submission by the firm: Firm has submitted following documents:
 Evidence of SYMBICORT 100 TURBUHALER (contains 100 mcg of budesonide and 6
mcg of formoterol fumarate dihydrate per dose) approved in Health Canada.
 Section approval letter dated 22-12-2020 specifying Dry powder inhaler -New section.
 GMP certificate of M/s Werrick Pharmaceuticals issued on the basis of inspection dated 12-
08-2022.
 DPI device: eziHaler (Trademark number 19748-D)
 Delivered dose label claim as:
Each delivered dose contains:
Budesonide………...………….80mcg
Formoterol Fumarate………….4.5mcg
Decision: Approved. Registration Board further decided that following label claim for
delivered dose shall also be declared on registration letter:
Formoterol Fumarate………….4.5mcg”
Brand Name +Dosage Form + Strength BUD-AIR Dry Powder Inhaler 400/6mcg
Budesonide…. 400mcg
Formoterol fumarate dihydrate….6mcg
Type of Form Form-5
Approval status of product in Reference Approved in Canada (MHRA)
Me-too status Venticort Rotacaps 100mcg+6mcg Capsule of Macter Int.
Remarks of the Evaluator. Reference product is powder for inhalation which is
different from applied formulation i.e. Rota cap for
inhalation.
 Evidence of approval of applied formulation in any RRA is not available
 Me-too status is not available.
08-2022.
1000. 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
Dairy No. date of R &I fee Form-5 Dy.No 6564 dated 14-02-2019 Rs.20,000/-
Dated 14-02-2019
Pharmacological Group Glucocorticosteroid/Selective β2 adrenoceptor
agonist
Type of form Form 5
Finished product specifications Manufacturer’s specifications
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.
Remark of the Evaluator XI
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 but have no approved
facility/section for manufacturing of DPIs section/manufacturing facility at present.
including specialized mixing facility to Moreover the firm submitted a list of
ensure the required particle size of the equipments that will be used in manufacturing
formulation blend. including eqipments for DPI mixing, DPI
filling, capsule polishing, blistering and
packaging. (No evidence of availability)
 As per 290th decision of Registration board, The firm submitted list of equipments for
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” (No evidence of
Size Distribution” as per Pharmacopoeia. availability)
 The reference formulation have mentioned The firm have revised the label claim
the hydrated form (dihydrate) of Formoterol mentioning the hydrated form of Formoterol
fumarate in the label claim while you have fumarate in the label claim
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 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.
th
Deferred for confirmation of required manufacturing facility “Dry Powder inhaler” section with
manufacturing and testing equiments for applied formulation.
Response by the firm: Firm has submitted following documents:
 Evidence of SYMBICORT FORTE TURBUHALER contains 400 mcg of budesonide and
12 mcg of formoterol fumarate dihydrate per dose approved in Health Canada.
 GMP certificate of M/s Werrick Pharmaceuticals issued on the basis of inspection dated
12-08-2022.
Formoterol Fumarate………….9mcg
Decision: Approved with Innovator’s specifications. The firm shall submit fee of Rs. 7500/-
for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
 Registration Board further decided that following label claim for delivered dose
shall also be declared on registration letter:
Formoterol Fumarate………….9mcg
Brand Name +Dosage Form + Strength IND-AIR Dry Powder Inhaler 150mcg
Indacaterol (as maleate)…. 150mcg
Type of Form Form-5
Approval status of product in Reference Approved in TGA
Me-too status Onbrez Breezhaler 150mcg Inhalation of Novartis Pharma
GMP status 17-01-2019: Grant of Section/Facility and Regularization.
Remarks of the Evaluator.
 Evidence of ONBREZ BREEZHALER indacaterol maleate 150 microgram hard capsule for
inhalation approved in TGA Australia.
08-2022.
Indacaterol……………………120mcg
Indacaterol……………………120mcg”
Brand Name +Dosage Form + Strength Oxytide-F Dry Powder Inhaler 50/100mcg
Type of Form Form-5
Pack size & Demanded Price 28‘s, 60‘s ; As per SRO
Approval status of product in Reference Approved in MHRA & TGA
Me-too status Seretide Accuhaler 50/100mcg of GSK
Remarks of the Evaluator. .
 Evidence of ADVAIR DISKUS 100/50 (is a purple plastic inhaler containing a foil blister
strip. Each blister on the strip contains a white powder mix of micronized fluticasone
propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg,
equivalent to 50 mcg of salmeterol base) approved in USFDA.
 The label claim of the innovator product is different from applied product and is as under:
Each blister on the strip contains:
Salmeterol (as Xinafoate)…. 50mcg
08-2022.
 The label claim as well as delivered dose of applied product contains salmetrol xinafoate
while innovator’s product provide label claim and delivered dose for salmetrol base. Firm
has not revised its claim or submitted any fee.
Decision: Approved. Firm will revise the formulation as per innovator’s product along with
submission of requisite fee as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
 Registration Board further decided that following label claim for delivered dose shall
also be declared on registration letter:
Fluticasone propionate….93mcg”
1003. Name and address of manufacturer / M/s Mafins Pharma A-5 S.I.T.E Super Highway,
Applicant Karachi
Brand Name +Dosage Form + Strength Dofin P 50mg Tablet
Composition Each sugar coated tablet contains:
Diclofenac potassium …50 mg
Diary No. Date of R& I & fee Dy.No.823, 9-01-2017, Rs.20,000/-
Type of Form Form-5
Approval status of product in Reference Diclofenac potassium 50 mg of Accord (MHRA)
Me-too status Zumaflam P of zumars Pharma
GMP status Last GMP Inspection dated 5-10-17 with conclusive
remarks of good cGMP compliance.
Remarks of Evaluator Revision of coating without fee
Decision of 282nd meeting of Registration Board:
Deferred for fee for the change of formulation, from enteric, film coated to sugar coated.
Firm has submitted fee PKR 30,000 vide slip number 6769329949 dated 31-10-2022 for revision
of formulation.
Decision: Approved.
1004.Name and address of M/s High-Q Pharmaceuticals Plot No. 224, Sector 23. Korangi
manufacturer / Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Spasfree plus 10/500mg Tablet
Strength
Hyoscine Butylbromide…10mg
Paracetamol…500mg
Diary No. Date of R& I & fee Dy No. 15190: 07-03-2019 (ORIGINAL APPLICATION)
Dy No. 26333: 19-09-2022 (DUPLICATE DOSSIER)
PKR 20,000/-: 06-03-2019
Pharmacological Group Analgesic / Antipyretic
Type of Form Form 5
Finished Product Specification Innovator’s specification
Me-too status Buscopan plus tablet by Martin Dow
GMP status GMP certificate issued on 02-02-2021 on the basis of inspection
Remarks of the Evaluator3.  Evidence of approval of applied formulation in reference regulatory
authorities / agencies which were adopted by the Registration Board
st
Decision of 321 meeting of Registration Board: Deferred for evidence of approval of applied formulation
in reference regulatory authorities/agencies which were declared/approved by the Registration Board in its
275th meeting.
Response by the firm: Firm has submitted reference of following RRA approved product:
Name: Buscopan Plus
Marketing Authorization Holder Name: CC Pharma GmbH
Composition: butylscopolaminium bromide 10mg / paracetamol 500mg film coated tablet
RRA: Germany Approved
Case No. 05 Deferred cases of cephradine containing formulations.
Registration Board in its 320th meeting considered the case of “Review of Reference status of Cephradine for
Injection” and decided as under:
Registration Board deliberated the matter in detail and acknowlwdged the fact that the “Cephradien
injection” has not been withdrawan from US market due to safety & efficacy reasons as evident from the
above cited notice published in US Federal Register. Hence, Registration Board decided to consider
pending registration applications in the light of aforementioned position.
Accordingly, the label claim and specifications of the innovator’s product and USP monograph have been
reviewed and based upon the label claim of “Velosef Injection 250mg”, “Velosef 500mg Injection” &
“Velosef injection 1gm” registered vide registration no. 001870, 001866 & 001869 respectively, advised the
PE&R division to issue registration letters as per following label claim for generic products.
Each vial contains:

Cephradine ……. 250mg
(with L-arginine)
Each vial contains:

Cephradine ……. 500mg
(with L-arginine)
Each vial contains:

Cephradine ……. 1g
(with L-arginine)
1005. Name and address of manufacturer / M/s Jawa Pharmaceuticals, (Pvt) Ltd. Quiad-e-
Applicant Azam Industrial area, Lot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Darphin Injection 1gm
Cephradine………...…..1gm
Diary No. Date of R& I & fee 19-10-2015 diary #1475 Rs.20000
Pharmacological Group 1st Generation Cephalosporin
Type of Form Form-5
Finished product Specifications BP Specifications
Approval status of product in Reference Velosef Injection 1gm by M/s Apothecon USFDA
Me-too status Cefrinex Injection 1gm by M/s Bosch (Reg#015129)
GMP status
Previous remarks of the Evaluator. Deferred for confirmation of approval status in
reference regulatory authorities. Moreover, product has
been discontinued by USFDA.
Previous Decision Deferred for confirmation of approval status in
been discontinued by USFDA (M-257).
Evaluation by PEC
Decision: Approved with USP Specifications.
Firm will revise the label claim as per the decision taken by the Boad in instant meeting
regarding Cephradine for Injection along with submission of requisite fee for pre-registration
correction/changes of label claim as per notification 7-11/2012-B&A/DRAP dated 07.05.2021
and 13.07.2021.
1006. Name and address of manufacturer / M/s Jawa Pharmaceuticals, (Pvt) Ltd. Quiad-e-
Applicant Azam Industrial area, Lot Lakhpat, Lahore
Brand Name +Dosage Form + Strength Darphin Injection 500mg
Composition Each vial contains:-
Cephradine…..….. 500mg
Type of Form Form-5
Finished product Specifications BP Specifications
Approval status of product in Reference FDA Velosef Injection 500mg by M/s Apothecon
GMP status
Previous remarks of the Evaluator. Deferred for confirmation of approval status in
been discontinued by USFDA.
Previous Decision Deferred for confirmation of approval status in
been discontinued by USFDA. (M-257).
Evaluation by PEC
regarding Cephradine for Injection along with submission of requisite fee for pre-
registration correction/changes of label claim as per notification 7-11/2012-B&A/DRAP
dated 07.05.2021 and 13.07.2021.
1007. Name and address of manufacturer / M/s. News Pharma, 42-Sundar Industrial Estate,
Applicant Raiwind Road, Lahore
Brand Name +Dosage Form + Strength New-Ceph Injection 250 mg IV
Cephradine with L- Arginine eq. to Cephradine 250 mg
Type of Form Form-5
Finished product Specifications USP Specification
Pack size & Demanded Price Per pack  Rs. Rs. 200/-
Approval status of product in Reference USFDA Velosef – Bristol
Me-too status Velosef - Bristol
GMP status
Previous remarks of the Evaluator. Veloef Injection 500mg by M/s GSK
Previous Decision
Evaluation by PEC Deferred for confirmation of approval status by
reference regulatory authorities. (M-261).
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength New-Ceph Injection 500mg IV
Cephradine with L- Arginine eq. to Cephradine 500 mg
Diary No. Date of R& I & fee Dy # 2480, Rs. 20,000/- 09-06-2016

Type of Form Form-5
Pack size & Demanded Price Per pack  Rs. Rs. 360/-
GMP status
Previous remarks of the Evaluator.
Previous Decision Deferred for confirmation of approval status by
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength New-Ceph Injection 1 GM IV
Cephradine with L- Arginine eq. to Cephradine…1gm
Diary No. Date of R& I & fee Dy # 2479, Rs. 20,000/-,09-06-2016

Type of Form Form-5
Pack size & Demanded Price Per pack  Rs. R/7777s. 650/-
GMP status
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1010. Name and address of manufacturer / M/s Semos Pharmacuticals (Pvt.) plot 11, sector 12-A,
Applicant North karachi industrial area Karachi
Brand Name +Dosage Form + Strength Semodin Dry Powder Injection
Composition Each vial Contains:
Cephradine…250mg
L-Ariginine….185mg
Diary No. Date of R& I & fee Dy.No.1543, Rs.20000/-, 03-08-2016

Type of Form Form-5
Pack size & Demanded Price Cost per vial of 250mg Rs. 38.87/-
Approval status of product in Reference Not Applicable
Me-too status Velosef BY Glaxo SmithKline
Pakistan.
GMP status GMP status as depicted in latest inspection report
(dated 27-9-14) is Good
Previous remarks of the Evaluator. Already considered products include 5 products related
to capsule cephalosporins, 7 cephalosporin suspension
section and 9 sterile dry powder vial injections in (M-
247&M-259). Now the firm has applied for 2 capsule
cephalosporin, 2 cephalosporin suspension and 1 sterile
powder vial for injection.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1011. Name and address of manufacturer / M/s.Medisave Pharma Lahore
Applicant
Brand Name +Dosage Form + Strength Piocef Injection 500mg
Broad-spectrum antibiotic
Cephradine with L-Arginine equilvalent to cephradine
Diary No. Date of R& I & fee 4-6-2012, Dy No.332, 8000/- &12000/-
Type of Form Form-5
Finished product Specifications Manufacturer’s Specs
Pack size & Demanded Price 1’s ,As per SRO
Approval status of product in Reference VELOSEF by APOTHECON, USFDA approved
Me-too status Cefatil by Highnoon
GMP status Last inspection, 09-05-2016, GMP is satisfactory
Previous Decision Deferred for confirmation of approval by reference
regulatory authorities. Board further directed to confirm
the reasons of Discontinued status of applied
formulation in USFDA (M-264)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1012. Name and address of manufacturer / M/s. Medisave Pharma Lahore
Applicant
Brand Name +Dosage Form + Strength Piocef Injection 1gm
Cephradine with L-Arginine eq.to cephradine
USP….1gm
Diary No. Date of R& I & fee 4-6-2012, Dy no. 352, 8000 &12000/-19-11-2014
st
Pharmacological Group 1 Generation Cephalosporin
Type of Form Form-5
Finished product Specifications Manufacturer’s Specs
Pack size & Demanded Price 1’s ,As per SRO
Approval status of product in Reference VELOSEF by APOTHECON, USFDA approved

Me-too status Cefatil by Highnoon
GMP status Last inspection, 09-05-2016, GMP is satisfactory
Previous Decision Deferred for confirmation of approval by reference
regulatory authorities. Board further directed to confirm
the reasons of Discontinued status of applied
formulation in USFDA (M-264)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1013. Name and address of manufacturer / M/s. MTI Medical (Pvt) Ltd.
Applicant 586-587 Sundar Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Dynarid Injection 1gm
Composition Each Vial contains:
Cephradine wih l-arginine …1gm
Diary No. Date of R& I & fee Diary No: 3453, 17/04/2017, Rs: 20,000/-
Pharmacological Group 1st Gen Cephalosporin
Type of Form Form-5
Finished product Specifications USP Specifications
Pack size & Demanded Price 1’s Vial with WFI 2x5ml / As per SRO
Approval status of product in Reference Velosef Injection 1gm by M/s Apothecon USFDA
Regulatory Authorities (disconinued)

GMP status 22-11-16
Grant of new section
Grant of Additional section Recommended
Previous remarks of the Evaluator.  Approval status of product in Reference Regulatory
Authorities not confirmed.
 Source of WFI (Medistil 5ml) by M/s Medisave
Pharmaceuticals (Reg#064758)
Previous Decision Deferred for evidence of approval of applied
formulation by reference regulatory authorities (M-
270).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1014. Name and address of manufacturer / M/s. MTI Medical (Pvt) Ltd.
Applicant 586-587 Sundar Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Dynarid Injection 500mg
Composition Each Vial contains:
Cephradine wih l-arginine …500mg

Type of Form Form-5
Finished product Specifications USP Specifications
Pack size & Demanded Price 1’s Vial with WFI 5ml / As per SRO
Approval status of product in Reference Velosef Injection 500mg by M/s Apothecon USFDA
Regulatory Authorities (disconinued)
Me-too status Cefrinex Injection 500mg by M/s Bosch (Reg#015128)

GMP status 22-11-16
Grant of new section
Grant of Additional section Recommended
 Source of WFI (Medistil 5ml) by M/s Medisave
formulation by reference regulatory authorities (M-
270).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1015. Name and address of manufacturer / M/s Pak-Heim International Pharma, Lahore
Applicant contract manufactured by Friends pharma, Lahore
Brand Name +Dosage Form + Strength Cefheim Dry powder for Injection 250mg
Cephradine (with l-Arginine)USP…….250mg
Diary No. Date of R& I & fee 2779, 16-8-2010, Rs 8000, Rs 42,000
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 1’s vial, As per SRO
Approval status of product in Reference USFDA (Discontinued)
Me-too status Velosef by GSK
GMP status Last inspection report (Friends Pharma) 6-10-2016. The
panel grant the cGMP for export purpose.
Previous remarks of the Evaluator.  No.F.8-6/2013-Reg-V Pakheim’s 8 numbers of
files has been send to PEC for evaluation. No
registration has been issued of contract to M/S
Pakheim Pharmaceutical, Lahore.
 Pakheim has following sections according to letter
No.F.1-16/99-Lic(vol-II). A) General Dry Syrup
B) General Sachet Section C) Ceph Dry Syrup.
 Friends Pharma has Injection (Dry powder
Cephalosporin) Section
Previous Decision Deferred for confirmation of approval status of
formulation in reference regulatory authorities. (M-
270).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Cephradine (with L-Arginine) USP….500mg
Diary No. Date of R& I & fee 7458, 9-8-2010, Rs 8000, Rs 42000
Type of Form Form-5
formulation in reference regulatory authorities (M-
270).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Cephradine (with l-Arginine) USP….1000mg
Diary No. Date of R& I & fee 7459, 9-8-2010, Rs 8000, Rs 42000
Type of Form Form-5
formulation in reference regulatory authorities (M-
270).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1018. Name and address of manufacturer / M/s. Sharex Laboratories (Pvt) Ltd., K.L.P. Road
Applicant Sadiqabad
Brand Name +Dosage Form + Strength F.radine Injection 250 mg IM/IV
Composition Each vial contains
Cephradine ………….. 250mg
Diary No. Date of R& I & fee Dy. No. 3318 : 21-12-2016
PKR 20,000/- : 20-12-2016
Type of Form Form-5
Pack size & Demanded Price 1’s : Rs 48/
Approval status of product in Reference USFDA approved but discontinued
Me-too status Cefrinex by Bosch
GMP status Last inspection report dated 11-05-2016 recommended
renewal of DML and grant of additional sections
Previous remarks of the Evaluator.  Evidence of approval of applied formulation with
active status of in market in reference regulatory
authorities could not be confirmed
 Firm has claimed shelf life of 3 years and stability
data sheet of only 1 batch which was manufactured
on 08-06-2013 and expired on 08-06-2016
Previous Decision Registration Board deferred all the applications
pertaining to the cephalosporin dry powder injection
section for clarification since stability studies
submitted by the firm shows manufacturing of
applied drugs before approval of section by the
Central Licensing Board. (M-271).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Applicant Sadiqabad
Brand Name +Dosage Form + Strength F.radine Injection 500 mg IM/IV
Cephradine…………. 500 mg
PKR 20,000/- : 20-12-2016
Type of Form Form-5
Approval status of product in Reference  USFDA approved but discontinued
Regulatory Authorities ANSM France approved as IV only but archived on
07-05-2011
on 08-06-2013 and expired on 08-06-2016
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Applicant Sadiqabad
Brand Name +Dosage Form + Strength F.radine Injection 1 gm IM/IV
Cephradine ………..1g
PKR 20,000/- : 20-12-2016
Type of Form Form-5
Approval status of product in Reference  USFDA approved but discontinued
07-05-2011
on 08-06-2013 and expired on 08-06-2016
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1021. Name and address of manufacturer / M/s City Pharmaceuticals, Plot No. 12A, 15 New
Applicant Servey No-276, Sector 5, Korangi Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Roxocef 500mg Injection
Cephradine…….500 mg
Diary No. Date of R& I & fee Dy No. 1079: 26-5-2016PKR 20,000/-: 25-5-2016
Type of Form Form-5
Pack size & Demanded Price As per PRC
Approval status of product in Reference  USFDA approved but discontinued.
Regulatory Authorities  ANSM France approved as IV only but archived on
07-05-2011.
GMP status Last inspection report dated 10-4-2017 confirms good
compliance to GMP
Previous remarks of the Evaluator.  Evidence of approval of applied formulation in
reference regulatory authorities could not be
confirmed
Previous Decision Deferred for evidence of approval in reference
regulatory authorities .(M-274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1022. Name and address of manufacturer / M/s City Pharmaceuticals, Plot No. 12A, 15 New
Applicant Servey No-276, Sector 5, Korangi Industrial Area,
Karachi
Brand Name +Dosage Form + Strength Roxocef 1000mg Injection
Cephradine…….1000 mg
Diary No. Date of R& I & fee Dy No. 1081: 26-5-2016PKR 20,000/-: 25-5-2016
Type of Form Form-5
Approval status of product in Reference  USFDA approved but discontinued.
Regulatory Authorities  ANSM France approved as IV only but archived on
07-05-2011.
GMP status Last inspection report dated 10-4-2017 confirms good
compliance to GMP
Previous remarks of the Evaluator.  Evidence of approval of applied formulation in
confirmed
Previous Decision Deferred for evidence of approval in reference
regulatory authorities .(M-274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1023. Name and address of manufacturer / M/s Semos Pharmaceuticals, Plot # 11, sector 12-A,
Applicant Industrial area, North Karachi
Brand Name +Dosage Form + Strength Semodin Dry Powder Injection IV/IM
Cephradine………1000 mg
(Mixture contains L-Arginine)
Diary No. Date of R& I & fee Dy.No. 1541, 3-8-16, Rs.20,000/-
Type of Form Form-5
Approval status of product in Reference  CEFRADINE PANPHARMA 1 g (ANSAM) status; is
Regulatory Authorities Archived (in 2016)
Me-too status AKSOSEF of AKSON PHARMACEUTICALS
remarks of Good level of cGMP compliance.
Previous remarks of the Evaluator.  Presence of L-arginine in formulation in stringent
regulatory author can’t be verified.
 Evidence of international availability can’t be
confirmed
Previous Decision Deferred for the evidence of approval of applied
formulation in reference regulatory
authorities/agencies which were declared/approved
by the Registration Board in its 249th meeting..(M-
274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Semodin 500 mg injection IV/IM
Type of Form Form-5
Approval status of product in Reference  CEFRADINE PANPHARMA (IV) 500 mg powder
Regulatory Authorities and solvent for solution for injection (ANSAM) but
Status is archived (2011)
confirmed
by the Registration Board in its 249th meeting..(M-
274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Semodin 500 mg injection IV/IM
Type of Form Form-5
Approval status of product in Reference CEFRADINE PANPHARMA (IV) 500 mg powder and
Regulatory Authorities solvent for solution for injection (ANSAM) but Status
is archived (2011)
confirmed
by the Registration Board in its 249th meeting.
.(M-274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1026. Name and address of manufacturer / M/s Barrett Hodgson Pakistan, F/423, S.I.T.E, Karachi.
Applicant
Brand Name +Dosage Form + Strength Cefbeck Injection(IV/IM) 1g
Sterile Cephradine with (sterile L-Arginine)… 1g
Diary No. Date of R& I & fee Dy No.1185; 28-12-2015; Rs.20,000/-
Type of Form Form-5
Pack size & Demanded Price 1’s; Rs.107.01/- or As per PRC
Approval status of product in Reference Approved in USFDA(discontinued)
Me-too status Velosef of GSK.
GMP status Last inspection report dated 8-8-2017 confirms

satisfactory compliance to GMP.
authorities/agencies.
.(M-274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Applicant
Brand Name +Dosage Form + Strength Cefbeck Injection(IV/IM) 500mg
Sterile Cephradine with (sterile L-Arginine)… 500mg
Diary No. Date of R& I & fee Dy No.1184; 28-12-2015; Rs.20,000/-
Type of Form Form-5

.(M-274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Applicant
Brand Name +Dosage Form + Strength Cefbeck Injection(IV/IM) 250mg
Sterile Cephradine with (sterile L-Arginine)… 250mg
Diary No. Date of R& I & fee Dy No.1189 ; 28-12-2015; Rs.20,000/-
Type of Form Form-5

.(M-274).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1029. Name and address of manufacturer / M/s Inventor Pharma, Plot No. K/196, S.I.T.E, (SHW)
Applicant Phase-II, Karachi
Brand Name +Dosage Form + Strength Incef 1gm I.V Injection
Cephradine …1gm
Type of Form Form-5
Pack size & Demanded Price 1’s/ As per SRO
Approval status of product in Reference USFDA(discontinued)
Me-too status Veloadvan 1gm Injection by M/s Advanced
GMP status GMP inspection conducted on 13-09-2022 concluded
good GMP compliance.
Authorities not confirmed
(USFDA discontinued.
Archived in ANSM France approved as IV on 07-5-
2011.)
Presence of L-arginine in formulation in Reference
Regulatory Authorities can’t be verified.
by the Registration Board.(M-277).
Evaluation by PEC
Firm will revise the label claim as per the decision taken by the Board in instant meeting
and 13.07.2021.
Brand Name +Dosage Form + Strength Incef 500mg I.V Injection
Cephradine …500mg
Type of Form Form-5
Me-too status Veloadvan 500mg Injection by M/s Advanced
(USFDA discontinued.Archived in ANSM France
approved as IV on 07-5-2011.).
 Presence of L-arginine in formulation in
Reference Regulatory Authorities can’t be
verified.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Incef 250mg I.V Injection
Cephradine …250mg
Type of Form Form-5
Me-too status Veloadvan 250mg Injection by M/s Advanced
(USFDA discontinued.Archived in ANSM France
approved as IV on 07-5-2011.).
 Presence of L-arginine in formulation in
Reference Regulatory Authorities can’t be
verified.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1032. Name and address of manufacturer / M/s EG Pharmaceuticals 13-A, industrial triangle,
Applicant Kahuta road Islamabad.
Brand Name +Dosage Form + Strength Selovef 500 mg injection IV
Cefradine……..500 mg
Type of Form Form-5
Pack size & Demanded Price 1’s / As per PRC
Approval status of product in Reference NA
Me-too status Aksosef of Akson Pharmaceuticals
GMP status Last GMP Inspection dated 22-06-2017 with
conclusive remarks of reasonable cGMP compliance
Previous remarks of the Evaluator.  CEFRADINE PANPHARMA (IV) 500 mg
powder and solvent for solution for injection
(ANSAM) but Status is archived (2011)
Previous Decision Registration Board deferred the case for
rectification of all the short coming as stated in GMP
inspection report. The Board further directed to
send a reference to QA & LT Division to conduct
GMP inspection of Firm on priority. (M-277).
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1033. Name and address of manufacturer / M/s Treat Pharmaceutical Industry(Pvt.) Ltd. A-37,
Applicant Small Industrial Estate Township Kohat Road Bannu.
Brand Name +Dosage Form + Strength TILOCEF-500mg INJECTION (IM/IV)
Cephradine with L-Arginine….500mg
Type of Form Form-5
Pack size & Demanded Price 1’s /As per SRO
Approval status of product in Reference USFDA discontinued
07.05.2011
Me-too status Linadine 500mg Injection by M/s Alina (Reg#070736)
GMP status 05/10/2017
Grant of renewal of DML and additional sections.
Panel recommends DML renewal and additional
sections
authorities could not be confirmed.
 Evidence of L-Arginine in formulation not
confirmed in Reference Regulatory Authorities.
 Firm has not submitted master formulation of
applied product.
Previous Decision Deferred for following:
 Evidence of approval of applied formulation
with active status of market in reference
regulatory authorities could not be confirmed.
Master formulation of applied product. (M-278)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength TILOCEF-250mgINJECTION (IM/IV)
Type of Form Form-5
Me-too status Fostrum 250mg Injection by M/s Pulse
sections
applied product.
Previous Decision : Deferred for following:
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength TILOCEF-1 g INJECTION(IM/IV)
Type of Form Form-5
Regulatory Authorities ANSM France approved separately as IV and IM but
archived on 26-04-2016
Me-too status Fostrum 1g Injection by M/s Pulse Pharmaceuticals
(Reg#074172)
sections
applied product.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength TILOCEF-1 g INJECTION(IM/IV)
Type of Form Form-5
Regulatory Authorities ANSM France approved separately as IV and IM but
archived on 26-04-2016
Me-too status Fostrum 1g Injection by M/s Pulse Pharmaceuticals
(Reg#074172)
sections
applied product.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1037. Name and address of manufacturer / M/s. Friends Pharma, 31 km, Ferozepur road Lahore
Applicant
Brand Name +Dosage Form + Strength Viocef injection 250 mg
Composition Each glass vial contains:
Cephradine HCl……… 250 mg
Diary No. Date of R& I & fee Dy. No.508; 9-1-2017; Rs. 20,000/-
Type of Form Form-5
GMP status Last GMP Inspection dated 6 oct 2016 with conclusive
remarks of cGMP compliance.
Previous remarks of the Evaluator.  Latest GMP inspection report (which should have
been conducted within the period of last one year).
 Evidence of approval of applied formulation in
confirmed
by the Registration Board in its 275th meeting and
updated status of GMP of the firm form QA & LT
division as inspection report submitted by firm is not
with in one year.
(M-281)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1038. Name and address of manufacturer / M/s Getz Pharma Karachi, contract manufacturing
Applicant from M/s Novamed Pharmaceuticals, Lahore
Brand Name +Dosage Form + Strength Lenwin powder for injection 250mg
Cephradine monohydrate eq to cephradine…..250mg
Diary No. Date of R& I & fee Dy. No.4339; 3-01-2017; Rs.50,000/- (30-12-2016)
Type of Form Form-5
Pack size & Demanded Price 1’s, Rs.150/-
GMP status Last inspection report (Novomed Pharmaceuticals) 5th
and 27th December 2017,firm is compliant to Good
cGMP guideline at the time of inspection.
Previous remarks of the Evaluator.  Firm has cephalosporin injectable section
by the Registration Board in its 275th meeting (M-
282)
Evaluation by PEC Capacity assessment inspection report of M/s
Novamed Pharmaceuticals Pvt Ltd, 28km
Ferozepur Road, Lahore presented in 295th meeting
of Registration Board wherein Board decided to
allow contract manufacturing from M/s Novamed
Pharmaceuticals Pvt Ltd, 28km Ferozepur Road,
Lahore for following sections:
 Dry Powder Injection (Cephalosporin)

Section
 Dry Powder Suspension (Cephalosporin)
Section
 Capsule (Cephalosporin) Section
 General Liquid Injection (Ampoule)
General Liquid Injection Vials (SVP)
and 13.07.2021.
upon satisfactory capacity assessment of manufacturing and testing facility of M/s
Novamed Pharmaceuticals, Lahore.
Brand Name +Dosage Form + Strength Lenwin powder for injection 500mg
Cephradine monohydrate eq to cephradine…..500mg
Type of Form Form-5
Approval status of product in Reference VELOSEF 500mg Injection by M/s APOTHECON
Regulatory Authorities (USFDA Discontinued)
Me-too status V-Sef Injection 500mg by M/s Z-JANS
Previous remarks of the Evaluator. Firm has cephalosporin injectable section.
by the Registration Board in its 275th meeting (M-
282)

Section
Section
dated 07.05.2021 and 13.07.2021.
 Registration Board further authorized its Chairman for issuance of registration
letter upon satisfactory capacity assessment of manufacturing and testing facility of
M/s Novamed Pharmaceuticals, Lahore.
Brand Name +Dosage Form + Strength Lenwin powder for injection 1gm
Cephradine monohydrate eq to cephradine…..1gm
Type of Form Form-5
Approval status of product in Reference VELOSEF 1000mg Injection by M/s APOTHECON
Regulatory Authorities (USFDA Discontinued)
Me-too status V-Sef Injection 1000mg by M/s Z-JANS
Previous remarks of the Evaluator. Firm has cephalosporin injectable section.
by the Registration Board in its 275th meeting. (M-
282)

Section
Section
and 13.07.2021.
upon satisfactory capacity assessment of manufacturing and testing facility of M/s
Novamed Pharmaceuticals, Lahore.
1041. Name and address of manufacturer / M/S High –Q Pharmaceuticals, Plot No ; 224/23
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Cefrinex 250mg Injection ( IV,IM)
Cephradine (as Dihydrate) with L-Arginine
……250mg
Diary No. Date of R& I & fee Dy.No.18912;24-10-2017; Rs.20,000/- (23-10-2017)
Type of Form Form-5
Pack size & Demanded Price 1’s; As per SRO
07.05.2011
Me-too status Welphardine 250mg Injection M/s WelMark
Pharmaceutical,
GMP status Last GMP inspection was conducted on 19-07-2017
and the report shows grant of GMP certificate.
Previous remarks of the Evaluator. Evidence of approval of applied formulation with

authorities/agencies which were adopted by the
Registration Board in its 275th meeting. (M-284)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1042. Name and address of manufacturer / M/S High –Q Pharmaceuticals, Plot No ; 224/23
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Cefrinex 500mg Injection ( IV,IM)
Cephradine (as Dihydrate) with L-Arginine
……500mg
Diary No. Date of R& I & fee Dy.No.18913; 24-10-2017; Rs.20,000/- (23-10-2017))
Type of Form Form-5
Approval status of product in Reference USFDA discontinued. ANSM France approved as IV
Regulatory Authorities only but archived on 07.05.2011
Me-too status Veloadvan 500mg Injection M/s
AdvancedPharmaceuticals,
GMP status Last GMP inspection was conducted on 19-07-2017
and the report shows grant of GMP certificate.
Previous remarks of the Evaluator. Evidence of approval of applied formulation with

Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1043. Name and address of manufacturer / M/s Standpharm (Pvt.) limited, 20 Km Ferozepur
Brand Name +Dosage Form + Strength Cephdine injection 250mg
Cephradine …………..250mg
Diary No. Date of R& I & fee Dy.No.17180; 05-10-2017; Rs.20,000/- (04-10-2017)
Type of Form Form-5
Finished product Specifications Not provided
Pack size & Demanded Price 1’s vial + solvent (WFI 5ML ampoule) & Rs.66/-per
vial
Approval status of product in Reference Discontinued in USFDA
Me-too status Velosef injection 250mg of M/s Squibb (Reg. # 001870)
the report concludes:
“The detailed inspection was conducted for
the verification of current GMP compliance. It was
notated that the firm had segregated the Cephalosporin
manufacturing facility, however, it was not truly
dedicated. The firm was advised to provide dedicated
facility for manufacturing of Cephalosporin products.
The overall facilities were found to be operating at
satisfactory level of GMP compliance at the time of
inspection. The firm had sufficient qualified/ technical
staff and given the commitment for re-vamping as a
continuous improvement activity.
Previous remarks of the Evaluator.  The official monograph of the applied formulation is
available in BP.
 The evidence of applied formulation in the reference
 Dedicated manufacturing facility for Cephalosporin
products in the applicant’s firm could not be
confirmed.
reference regulatory authorities/ agencies which
meeting.
 Dedicated manufacturing facility for
Cephalosporin products. (M-285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Cephdine injection 500mg
Cephradine …………..500mg
Type of Form Form-5
Pack size & Demanded Price 1’s vial + solvent (WFI 5ML ampoule) & Rs.66/-per
vial
Me-too status Velosef injection 250mg of M/s Squibb (Reg. # 001870)
Previous remarks of the Evaluator.  The official monograph of the applied formulation is
available in BP.
 The evidence of applied formulation in the reference
 Dedicated manufacturing facility for Cephalosporin
products in the applicant’s firm could not be
confirmed.
reference regulatory authorities/agencies which
meeting.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Cephdine injection 1g
Cephradine….1g
Type of Form Form-5
Pack size & Demanded Price 1’s vial + solvent (w.f.i.10ml ampoule) & Rs. 160/vial
Me-too status Cephradine 1g Injection of M/s Highnoon (Reg.#
009140)
Previous remarks of the Evaluator.  The official monograph of the applied
formulation is available in BP.
 The evidence of applied formulation in the
confirmed.
Cephalosporin products in the applicant’s firm
could not be confirmed.
reference regulatory authorities/ agencies which
meeting.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1046. Name and address of manufacturer / M/s Himedic Pharmaceutical (Pvt.) Limited, 19-km
Applicant Link Multan Road, Lahore.
Brand Name +Dosage Form + Strength Hidin injection 250mg
Cephradine with L- Arginine eq. to
Cephradine…..250mg
Diary No. Date of R& I & fee Dy. No. 7686; 06-07-2017; Rs.20,000/-(06-07-2017)
Type of Form Form-5
Finished product Specifications Manufacturers
Pack size & Demanded Price 1’s vial + solvent (w.f.i.10ml ampoule) & Rs. 160/vial
Approval status of product in Reference 1x 1 vial & Rs. 44/- or as per SRO
Me-too status Discontinued in USFDA
GMP status Velosef injection 250mg of M/s Squibb (Reg. # 001870)
Previous remarks of the Evaluator. Last GMP inspection was conducted on 09-08-2018 and
the 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 Decision Deferred 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.
which were declared/approved by the
 Justification of the applied 5% overage. (M-
285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Hidin injection 500mg
Cephradine with L- Arginine eq. to
Cephradine…..500mg
Type of Form Form-5
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)
following remarks:
Previous remarks of the Evaluator.  International availability of the applied
formulation could not be confirmed.
 5% overage is applied.
 The official monograph of the 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.
status.
in reference regulatory authorities/ agencies
285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Hidin injection 1g
Cephradine with L- Arginine eq. to Cephradine…..1g
Type of Form Form-5
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)
following remarks:
Previous remarks of the Evaluator.  International availability of the applied
formulation could not be confirmed.
 5% overage is applied.
 The official monograph of the 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.
status.
285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1049. Name and address of manufacturer / M/s. Aries Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Cefradin IV/IM Injection 250mg.
Cephradine L-Arginine Eq. to Cephradine
…….250mg.
Diary No. Date of R& I & fee Dy. No 9612 dated 01-03-2019 Rs.20,000/- Dated 01-
03-2019
Type of Form Form-5
Approval status of product in Reference N/A
Me-too status Velosef Injection by GSK-Pakistan
GMP status 26-02-2019 Grant of Additional Section.
Panel recommends grant of Additional Section.
Previous remarks of the Evaluator. Evidence of approval of applied formulation in
Previous Decision  Deferred for evidence of approval of applied
authorities/agencies which were adopted by
the Registration Board in its 275thmeeting..
(M-285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Applicant
Brand Name +Dosage Form + Strength Cefradin IV/IM Injection 500mg.
…….500mg.
03-2019
Type of Form Form-5
Approval status of product in Reference Cefril-A Injection Bristol-Myers Squibb
the Registration Board in its 275thmeeting
(M-285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Applicant
Brand Name +Dosage Form + Strength Cefradin IV/IM Injection 1000mg
…….1000mg.
03-2019
Type of Form Form-5
Approval status of product in Reference Cefril-A Injection Bristol-Myers Squibb
the Registration Board in its 275thmeeting.
(M-285)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1052. Name and address of manufacturer / M/s Amros Pharmaceuticals, A-96, S.I.T.E. Super
Applicant Highway, Karachi.
Brand Name +Dosage Form + Strength Volvocef 250mg Injection
Cephradine with Sterile Arginine eq. to
Cephradine......250mg
Diary No. Date of R& I & fee Dy. No. 8715 dated 27/07/2019 Rs.20,000/-
26.02.2019
Type of Form Form-5
Finished product Specifications USP specifications
Pack size & Demanded Price 1‘s:
Approval status of product in Reference Cannot be confirmed
Me-too status Velosef 250mg Injection Reg: No. 001870 Bristol Myer
Squib Pakistan/GSK.
GMP status Last inspection report dated 18/07/2018 confirms the

current compliance level as Good.
reference regulatory authorities/agencies could not be
confirmed.
Previous Decision  Deferred for Evidence of approval of applied
authorities/agencies which were
declared/approved by the Registration Board
(M-291)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Volvocef 500mg Injection
Cephradine......500mg
26.02.2019
Type of Form Form-5
Approval status of product in Reference Cannot be confirmed
Me-too status Velosef Injection Reg: No. 001866 Bristol Myer Squib
Pakistan/GSK
confirmed.
(M-291)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Brand Name +Dosage Form + Strength Volvocef 1g Injection
Cephradine......1g
26.02.2019
Type of Form Form-5
Approval status of product in Reference Approved in National Agency for the Safety of
Regulatory Authorities Medicine and Health Products (ANSM), France
Me-too status Cannot be confirmed
confirmed.
(M-291)
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
1055. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No.224/23, Korangi
Applicant Industrial
Area, Karachi (Dry powder injection vials
Cephalosporin).
Brand Name +Dosage Form + Strength Cefrinex 1gm Dry powder for injection.
1gm sterile cephradine with sterile arginine.
Diary No. Date of R& I & fee Dy. No 18914 dated 24-10-2017; Rs. 20,000/- dated
31-10-2016.
Duplicate File Bearing Dy. No.151 dated 19-04-2021.
Type of Form Form-5
Finished product Specifications USP specifications.
Pack size & Demanded Price 1’s & As per SRO.
Approval status of product in Reference Could not be confirmed.
Me-too status Cefrinex vial 1000mg, Reg. No. 015129.
GMP status Same as above.
Previous remarks of the Evaluator. Firm has provided Velosef 1gm injection in HPRA
(Ireland)
which could not be verified.
• Evidence of approval of applied formulation in
reference
regulatory authorities/agencies which were adopted by
the
Registration Board in its 275th meeting. Provided
evidence is
discontinued.
Evaluation by PEC
dated 07.05.2021 and 13.07.2021.
Case No. 06 Cases in which firms have not yet submitted complete response.
1056.Name, address of Applicant / Marketing M/s Bio-Next Pharmaceuticals Plot No. 50, St
Authorization Holder No. S-10, RCCI Industrial Estate Rawat
Islamabad.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name NEXIDORE 250mg Injection
Pharmaceutical ingredient (API) per unit Doripenem Monohydrate Eq. to
Doripenem…250mg
Pharmaceutical form of applied drug Glass vial filled with white to slightly yellowish,
off white crystalline powder.
Reference to Finished product specifications In house
The status in reference regulatory authorities Finibax Intravenous Infusion 0.25g (PMDA
Japan Approved)
Name and address of API manufacturer. KOPRAN RESEARCH LABORATORIES
LIMITED K4/4, Additional MIDC, At & Post
Birwadi, Taluka Mahad, District Raigad - 402 302
Maharashtra, INDIA
product.
Firm has not submitted verification studies of
analytical method for the testing of drug
substance.
Pharmaceutical Equivalence and Comparative Not performed by the firm
Dissolution Profile
Analytical method validation/verification of Firm has submitted report of validation of
product analytical method for the drug product.
Manufacturer of API KOPRAN RESEARCH LABORATORIES LIMITED K4/4, Additional

MIDC, At & Post Birwadi, Taluka Mahad, District Raigad - 402 302
Maharashtra, INDIA
API Lot No. DIPV/B2002002,
DPIV/P2001003,
DPIV/P2001004
Description of Pack
Glass vial
Batch No. DN-001 DN-002 DN-003
No. of Batches 03
manufacturer issued by concerned regulatory KD/89275/2020/11/33788) issued by FDA
authority of country of origin. Mahrashtra dated 20-10-2020. The certificate is
or analysis” for import of Doripenem 3Kg from
M/s Kopran Research Laboratories Limited
K4/4, Additional MIDC, At & Post Birwadi,
Taluka Mahad, District Raigad - 402 302
Maharashtra, INDIA issued by AD (I&E) DRAP
field office. The license was issued on 08-04-
2020.
3Kg doripenem Batch No. DIPV/B2002002,
DPIV/P2001003, DPIV/P2001004.
data sheets etc.
audit trail reports on product testing testing of HPLC for two day 24-04-2020 and 25-
04-2020.
Evaluation by PEC:

1. Submit differential fee for the registration of
applied product, since the notification for revision
of fee vide SRO No. F.7-11/2012-B&A/DRA was
published on 7th May 2021 while this application
was received in R&I section of DRAP on 3 rd
September 2021.
2. Submit module 1 as per the CTD guidance Module I is submitted as per CTD guidance
document approved by Registration Board by document.
providing all the information and documents in
relevant sections / sub-sections instead of
referring to annexures.
3. Justify the finished product specifications as Product specifications are revised as per Japanese
“Inhouse specifications” since the drug product Pharmacopoeia referred to “supplement II to
monograph is available in Japanese Japanese Pharmacopoeia seventeenth edition”
Pharmacopoeia. Revise your specifications along notified on June 28th, 2019 and later on circulated.
with submission of requisite fee. Revised FPP specifications, method of analysis is
submitted.
4. Justify the use of drug substance having in house Revised specification & method of analysis for
specifications while the drug substance Doripenem hydrate as per JP is submitted.
specifications are present in JP monograph for
“Doripenem hydrate”
5. Justify the limit of water from 4.0 – 5.5% in drug Drug substance was analyzed using a manufacturer
substance specifications, while JP monograph specs and method of analysis at time of development.
specifies the limit from 4.0 – 5.0%. Moreover, in water contents of drug substance also
qualifies the acceptance limit of JP.
6. Justify why the test for residue on ignition is not Drug substance was analyzed using a manufacturer
performed for the drug substance since it is specs and method of analysis at time of development
recommended in JP monograph. where residue on ignition wasn’t part of
specifications. Now revised specs is submitted.
7. Submit data in section 3.2.S.4.1 as per the Specifications & method of analyses from Drug
guidance document approved by Registration Substance & Drug Product manufacturers is
Board which specifies that “Copies of the Drug submitted.
substance specifications and analytical
procedures used for routine testing of the Drug
8. Justify the use of a different analytical method for Drug substance was analyzed by using
assay testing of drug substance from that manufacturer’s method of analysis at time of
specified in JP monograph. The method of drug development that is why testing conditions differs
substance manufacturer is different in terms of from that of JP monograph.
HPLC column specifications, column
temperature, mobile phase, UV detector Product specifications are revised as per Japanese
wavelength, flow rate, standard preparation Pharmacopoeia referred to “supplement II to
method and final concentration of standard Japanese Pharmacopoeia seventeenth edition”
solution, sample preparation method and final notified on June 28th, 2019 and later on circulated.
concentration of sample solution, system
suitability requirements and acceptance criteria Revised drug substance specification & method of
and the formula for calculation of results of assay. analysis as per JP is submitted.
9. Submit data in section 3.2.S.4.3 as per the At time to development we followed in-house method
decision of 293rd meeting of Registration Board, of analysis and submitted analytical method
which states that “Analytical Method Verification validation.
studies including specificity, accuracy and We started following the JP at 12 months’ study time-
repeatability (method precision) performed by the point. Now the Analytical Method Verification
Drug Product manufacturer for both compendial Protocol & Report is submitted.
as well as noncompendial drug substance(s) shall
be submitted”. Further justify how the analysis of
drug substance was conducted without
performing verification studies of the analytical
method of drug substance.
10. Justify how 260mg of Doripenem Monohydrate Molecular weight of Doripenem Monohydrate =
eq.to Doripenem is equivalent to 250mg of 438.52
doripenem as per the label claim. Molecular weight of Doripenem = 420.50
Factor = 438.52 / 420.50 = 1.04
Equivalent weight ofDoripenem monohydrate for
250mgDoripenem = 250 x 1.04 = 260mg
11. Justify how the applied drug is to be supplied with 10ml of sodium chloride 0.9% solution is for primary
10ml of sodium chloride 0.9% solution, since the reconstitution which will then be further diluted as
innovator product recommends different volume per requirements.
for reconstitution.
12. Justify why pharmaceutical equivalence studies As Nexidore 250mg injection is ready to fill product,
are not performed. and fill weight of 250mg injection is half of 500mg
injection. There is no addition of any other contents
in the formulation so pharmaceutical equivalence
study has been done against dorinem 500mg
injection by ICI Pakistan.
13. The process validation protocols does not contain Revised prospective process validation protocol is
any steps to ensure the sterilization of vials and submitted.
rubber stopper is adequately performed, further
the time and temperature of sterilization cycle is
also not validated. Justification is required in this
regard.
14. Justify the drug product specifications section Product specifications has been revised as per
(3.2.P.5.1) with water contents from 4.0% to Japanese Pharmacopoeia referred to “supplement II
5.5% while the JP monograph for the drug to Japanese Pharmacopoeia seventeenth edition”
product specifies water contents to be 4.0 to 5.0%. notified on June 28th, 2019 and later on circulated.
Moreover during stability study the water contents
results also complies the JP limits(4-5%)
15. Justify the limit of assay from 90 – 115% since Product specifications has been revised as per
the JP monograph specifies the assay limit from Japanese Pharmacopoeia referred to “supplement II
95 – 105%. to Japanese Pharmacopoeia seventeenth edition”
notified on June 28th, 2019 and later on circulated.
Moreover during stability study the Nexidore assay
results also complies the JP limits(95-105%).
16. Justify the use of a different analytical method for Drug substance was analyzed by using
assay testing of drug product from that specified manufacturer’s method of analysis at time of
in JP monograph. The analytical method of drug development that is why testing conditions differs
product is different in terms of HPLC column from that of JP monograph.
specifications, column temperature, mobile
phase, UV detector wavelength, flow rate, total Product specifications are revised as per Japanese
run time and retention time, standard preparation Pharmacopoeia referred to “supplement II to
method and final concentration of standard Japanese Pharmacopoeia seventeenth edition”
solution, sample preparation method and final notified on June 28th, 2019 and later on circulated.
concentration of sample solution, system
suitability requirements and acceptance criteria Revised specification & method of analysis for drug
and the formula for calculation of results of assay. product as per JP is submitted.
17. Justify the assay preparation step in the assay No justification is provided by the firm.
testing of drug product specifications in which the
contents of only 1 vial is taken, justify how the
contents taken from only 1 vial can be considered
representative of the whole batch.
18. Justify why the test of specificity is not performed Nexidore Injection is ready to fill product. It doesn’t
during the validation studies of the analytical contain inactive ingredients, so there wouldn’t need
method of drug product. the test of specificity during validation studies.Now
we are following JP method and analytical method
verification study of product is attached with
inclusion of specificity.
19. Provide details of the concentration in mg/ml of Concentration of 50% solution in mg/ml:
different solutions i.e. 50% to 150% used in 125/100 x 1/50 = 0.025mg/ml
accuracy and precision testing during validation
studies. Concentration of 100% solution in mg/ml:
250/100 x 1/50 = 0.05mg/ml
Concentration of 150% solution in mg/ml:
375/100 x 1/50 = 0.075mg/ml
The concentration of standard solution
recommended by JP is 0.125mg/ml which is
different from the 100% concentration used by the
firm.
20. Justify why the test of water contents and Both tests have now been performed on drug product
uniformity of dosage units is not performed in the
batch analysis stage.
21. Justify the release of drug product batches on 25- This is no GMP, non-commercial batch produced for
04-2020 after performing test of sterility, since R&D and stability purpose. In case of product
the drug substance was released after testing on development and stability batches the product does
24-04-2020. Justify how the three batches were not have to go to market normally all test including
manufactured and stability studies were being sterility are started from zero point. Hence in case of
performed within 1 day only. product development in order to achieve stability
time lines, all test can be started together. Since the
product has to stay at stability for atleast three months
so by the time sterility will come up and if any test
fails the results will together come up.
22. Justify the use of 25ml type-II glass vial for the It was typo error at time of submission. It is 15mL
applied drug product since as per your submission Type I glass vial.
the drug product is to be reconstituted in 10ml
normal saline.
23. Justify how the results of initial time point is The product has been tested separately for real time
different at real time and accelerated stability data and accelerated time stability that’s why their results
sheet for batch DN-001 and DN-002. vary but it is in acceptable range.
24. Justify how the results of pH and assay of batch It is typo error
DN-001 and DN-002 at initial time point in real
time stability studies is exactly same.
25. You have submitted that all stability batches were Three stability batches were manufactured with
manufactured using the drug substance batch No. 312gm of powder from each of 3 containers.
DPIV/P2001003. For manufacturing of 3 batches Consumption detail of each API lots for
each having batch size 1200 vials, approximately manufacturing of three stability batches are:
1.87Kg drug substance is required, while as per
the clearance documents and commercial invoice Nexidore 250mg Injection (DN-001):
1Kg drug substance of batch number DPIV/B2002002
DPIV/P2001003 was imported. Justify how three Nexidore 250mg Injection (DN-002):
batches were manufactured using the drug DPIV/P2001003
substance having batch number DPIV/P2001003. Nexidore 250mg Injection (DN-003):
DPIV/P2001004
Firm has not submitted documents for import of these

lots of API.
26. Justify why stability testing was not performed We have already submitted complete accelerated
for the drug product at the end of accelerated stability study data (6 months). However, attaching
stability study. again herewith for your review in Annexure 13.we
are also providing 9th, 12th, 18th stability study data
as per JP method.
27. Submit compliance record of HPLC software Submitted by the firm.
21CFR & audit trail reports on product testing for
each analysis performed during the study.
Decision: Registration Board after thorough deliberation observed that the firm has not developed the
product as per specifications laid down in Japanese Pharmacopoeia. The Board therefore decided not
to accept the stability study data and advised the applicant to again perform product development and
stability studies of three batches and submit the data on Form 5-F as per the relevant guidance
document.
1057.Name, address of Applicant / Marketing M/s Kaizen Pharmaceuticals (Pvt) Ltd. E-127-
Authorization Holder 129, North Western Industrial Zone Bin Qasim
Karachi.
Name, address of Manufacturing site. M/s Kaizen Pharmaceuticals (Pvt) Ltd. E-127-129,
North Western Industrial Zone Bin Qasim Karachi.
☐ Importer
GMP status of the firm Firm has submitted copy of GMP inspection report
dated 11-08-2020 concludes satisfactory
compliance to GMP.
Firm has submitted copy of GMP certificate of
dated 16-09-2020 based on the inspection dated
28-08-2019.
The GMP certificate specifies Tablet (General)
section.
Evidence of approval of manufacturing facility Firm has submitted copy of letter for issuance of
DML dated 24-09-2012 specifying Tablet section.
Firm has submitted copy of GMP certificate of
dated 16-09-2020 based on the inspection dated
28-08-2019.
The GMP certificate specifies Tablet (General)
section.
☐ Export sale
The proposed proprietary name / brand name SAFIMIDE 100mg Tablet
Strength / concentration of drug of Active Each film coated tablet Contains:
Pharmaceutical ingredient (API) per unit Safinamide as mesylate………100mg
Pharmaceutical form of applied drug Orange round biconvex film coated tablet
Pharmacotherapeutic Group of (API) Monoamine oxidase B inhibitors (N04BD03)
Reference to Finished product specifications Manufacturer’s specification
Proposed Pack size 3 x 10’s
The status in reference regulatory authorities Xadago Tablets (USFDA Approved)
Clinical Indiciations and Use: XADAGO is indicated as adjunctive treatment to
levodopa/carbidopa in patients with Parkinson’s
disease (PD) experiencing “off” episodes.
Name and address of API manufacturer. Menovo Pharmaceutical Co. Ltd. 7 Wei 11 Road,
Hangzhou Gulf Industrial Area, Shangyu Zhejiang
China.
product.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Dissolution Profile equivalence for their product against the innovator
product Xadago tablet manufactured by Zambon.
Firm has submitted results of Comparative
dissolution profile in three medium for their
product against the innovator product Xadago
tablet manufactured by Zambon.
Manufacturer of API Menovo Pharmaceutical Co. Ltd. 7 Wei 11 Road, Hangzhou Gulf Industrial
Area, Shangyu Zhejiang China.
API Lot No. PD/SAF/05/1511/02R
Description of Pack
Alu-PVC blister
Batch No. TF#01 TF#02 TF#03
No. of Batches 03
1. Reference of previous approval of applications Firm has referred to their last onsite inspection
with stability study data of the firm (if any) 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
 Audit trail on the testing reports is available.
for stability chamber. Chambers are controlled
 Related manufacturing area, equipment,
personnel and utilities are GMP compliant.
2. Approval of API/ DML/GMP certificate of API Firm has submitted GMP certificate of M/s
manufacturer issued by concerned regulatory Zhejiang Menovo Pharmaceutical Co. Ltd. No. 8,
authority of country of origin. Jing 13 Road, Hangzhou Gulf Shangyu Economic
and Technological Development zone, Shangyu
City Zhejiang Province China. Issued by Agency
for medicinal products and medical devices of the
republic of Slovenia on the basis of inspection dated
13-03-2017.
3. Documents for the procurement of API with Firm has submitted copy of proforma invoice
approval from DRAP (in case of import). number YP016 dated 26-03-2018 from Ningbo
Menovo Pharmaceutical Co. Ltd. Specifying 750g
safinamide mesylate. The Invoice is not cleared by
AD (I&E).
Firm has also submitted copy of DHL invoice with
airway bill number 4495533405.
4. Data of stability batches will be supported by Firm has submitted complete stability data of 3
attested respective documents like batches for 6 months.
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has submitted certificate of 21 CFR
audit trail reports on product testing compliance of HPLC system along with report of
audit trail.
humidity monitoring of stability chambers (real accelerated and real time stability chambers.
Evaluation by PEC:

1. Submit complete label claim in section 1.5.2 Each film coated tablet Contains:
stating complete description of product Safinamide as mesylate………100mg
whther film coated tablet or otherwise along
with exact salt form and quantity of drug
substance contained, since you have only
mentioned 100mg.
2. Submit data in section 3.2.S.3 regarding the Firm has submitted characterization studies of the drug
characterization of drug substance and its IR substance along with IR spectra.
spectra.
3. Submit data in section 3.2.S.4.1 as per the Firm has submitted specifications and analytical method
guidance document approved by Registration of drug substance from drug product manufacturer as
Board which specifies that “Copies of the well.
4. Provide verification studies of drug substance Firm has submitted analytical method verification
from drug product manufacturer in section studies of the drug substance.
3.2.S.4.3.
5. Provide COA of relevant batch of drug Firm has submitted COA of relevant lot of API having
substance which is used in the manufacturing batch number PD/SAF/05/1511/02R, from both API
of batches of drug product in section manufacturer as well as product manufacturer.
3.2.S.4.4, since COA of different batches is
provided in this section.
6. Submit COA of reference standard used for Firm has submitted COA of reference standard.
analysis of drug substance in section 3.2.S.5.
7. Submit Description of the container closure Firm has submitted complete details of section 3.2.S.6
system(s) for the shipment and storage of the with details of container closure system.
API including materials of construction of
each primary packaging component in section
3.2.S.6.
8. Submit data in relevant section / sub-section Firm has again submitted module 3.2.P as per CTD
of module 3.2.P instead of referring to guidance document.
annexures.
9. Submit information and master formulation in Firm has submitted master formulation and description
section 3.2.P.1 of drug product as per guidance document in section
3.2.P.1
10. Submit complete details of all subsections Firm has submitted section 3.2.P.2 as per CTD guidance
related to pharmaceutical development in document.
section 3.2.P.2 and its sub sections.
11. Justify why the qualitative composition of The composition of the product for core is same as
product is different from that of innovator’s innovator’s product. The coating material used in
product. innovator is hypromellose while we are using ready
made coat Shef Coat in which polymer used is also
hypromellose.
12. Description of manufacturing process and Firm has submitted description of manufacturing
process controls in section 3.2.P.3.3. process and process controls for the applied
formulation.
13. Controls of critical steps and intermediates in Firm has submitted controls of critical steps and
section 3.2.P.3.4. intermediates for the applied formulation.
14. You have mentioned product description as It was a typo mistake in section 3.2.P.5.1.
Orange round biconvex film coated tablet in
section 3.2.P.1 and white round biconvex
tablet in section 3.2.P.5.1. Justification is
15. Justify the dissolution acceptance criteria Complete dissolution profile (CDP) shows that our
NLT 75% in 30 minutes since the dissolution product attains 90% dissolution in 15 minutes. This is
criteria of innovator’s product is NLT(Q) in similar to the innovator’s product more than 90%
20 minutes. dissolution is achieved at 30 minutes.
Dissolution is achieved at 30 minutes.
In FDA dissolution guidelines the sampling time for
safimide tablet are upto 45 minutes. That’s why we
have set dissolution criteria NLT 75% in 30 mins
although our products meet this criteria in 15 minutes as
that of innovator’s product.
16. Submit validation report of analytical method Firm has submitted validation report of analytical
of drug product in section 3.2.P.5.3 instead of method of drug product.
submitting raw data and chromatograms.
17. Submit batch analysis report of three batches Firm has submitted batch analysis report of three
in section 3.2.P.5.4. stability batches.
18. Submit information in section 3.2.P.5.5 and Firm has submitted information of impurity
3.2.P.5.6. characterization and justification of specifications in
section 3.2.P.5.5. and 3.2.P.5.6.
19. Submit COA of reference standard actually Firm has submitted COA of reference standard.
used in the analysis of drug product in section
3.2.P.6.
20. Submit complete details of container closure Firm has submitted details of container closure system.
system of the drug product in section 3.2.P.7.
21. Submit details and information in section Firm has submitted summary and conclusion of stability
3.2.P.8.1. studies batches in section 3.2.P.8.1
22. Provide stability data submmary sheets of Firm has submitted stability study data after proper
three batches of drug product as per the arrangement in a sequence along with raw data sheets.
format provided in CTD guidance document
in a proper sequence, since your submitted
format does not contain information of API
lot number and also not provided in any
sequence.
23. The submitted chromatograms does not There was a technical problem in software that’s why
contain any details of the time of time was not mentioned in chromatograms.
chromatogram acquisition and processing.
Clarification is required in this regard.
24.  Submit stability study data in section Firm has submitted data as per 6 points checklist.
3.2.P.8.3 as per the checklist approved by
Registration Board in its 296th meeting and
the CTD guidance document, which
includes the following:
o Reference of previous approval of
applications with stability study data of
the firm (if any)
o Approval of API/ DML/GMP certificate
of API manufacturer issued by concerned
regulatory authority of country of origin.
o Documents for the procurement of API
import).
o Data of stability batches will be
supported by attested respective
documents like chromatograms, Raw
data sheets, COA, summary data sheets
etc.
o Compliance Record of HPLC software
testing.
o Record of Digital data logger for
temperature and humidity monitoring of
both stability chambers.
 Firm will revise the dissolution specifications to NLT(Q) in 20 minutes and perform
dissolution test as per revised acceptance criteria for commercial batches.
1058. Name, address of Applicant / Marketing M/s PDH Laboratories Pvt Ltd. 9.5 km,
Authorization Holder Sheikhupura Road, Lahore.
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot
No. 81, Sunder Industrial Estate, Lahore.
☐ Importer
Cunningham Pharmaceuticals (Pvt) Ltd dated 19-
04-2019 based on the inspection dated 01-04-2019.
The GMP certificate specifies Dry powder
suspension (cephalosporin) section.
DML of M/s Cunningham Pharmaceuticals (Pvt)
Ltd dated 13-06-2016 specifying Dry powder
☐ Export sale
The proposed proprietary name / brand name PDFIM 100mg/5ml Dry Suspension
Pharmaceutical form of applied drug White to light yellow powder filled in amber colored
glass bottle
Proposed Pack size 30 ml
drug product.
analysis and justification of specification, reference
standard, container closure system and stability
studies of drug substance.
30°C ± 2°C / 65 ± 5% RH for 36 months.
Dissolution Profile equivalence for all the quality tests for their product
against Cebosh dry suspension of Bosch
pharmaceuticals.
API Lot No. 00243/342/2017
Description of Pack
Batch No. 180012 180013 180015
Batch Size 5,000 bottles 5,000 bottles 5,000 bottles
No. of Batches 03
1. Reference of previous approval of applications No previous PSI has been conducted
manufacturer issued by concerned regulatory by Additional Director DRAP, dated 11-01-2019.
dated 08-01-2019.
attested respective documents like chromatograms, along with raw data sheets, HPLC chromatograms,
Raw data sheets, COA, summary data sheets etc. COA and summary data sheets.
Evaluation by PEC:
Registration Board in its 320th meeting considered the case of Cefixime 100mg/5ml dry suspension
manufactured by M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot No. 81, Sunder Industrial Estate, Lahore
wherein the Board decided to defer for following points for which the response is tabulated below:
Sr. No Reasons for deferment Response by the firm

1. Scientific justification for having different The firm has submitted revised specifications for drug
specifications of the drug substance from that of substance as per B.P.
API manufacturer as well as BP monograph
2. Scientific justification how a revised method of The format of SOP For Cefixime was revised in February
February 2021 can represent the results of the 2021. However, the testing method was same as that of
stability studies which were initiated in March stability studies initiated in 2018. We didn’t change the
2018. testing method of API, only format was revised with new
revision number and date.
3. Scientific justification for performing The firm has stated that the verification studies were
verification studies of the analytical method of performed for analytical method as provided in the section
drug substance using a different analytical 3.2.S.4.2. Furthermore, the calculation method is also as
method from that specified in section 3.2.S.4.2. per B.P. The firm has submitted relevant chromatogram
and raw data sheets.
4. Submission of stability study data of three The firm has submitted stability study data of three batches
batches of cefixime trihydrate (micronized) (real time: 36 months : Accelerated : 06 months) according
from the API manufacturer as per zone IV-A to the conditions of Zone IV-A.
conditions. Batches: 00243/001/2018, 00243/100/2018,
00243/200/2018
5. Submission of pharmaceutical equivalence and Pharmaceutical equivalence and CDP studies have been
Comparative Dissolution Profile (CDP) against performed against Cefspan dry suspension mfg by M/s
the innovator’s product. Barret Hodgson. The firm has submitted the relevant data
including calculations of F2 values.
6. Submission of preservative effectiveness The firm has performed preservative effectiveness studies
studies. and presented the data in relevant section (document no.
SOP-MB/02-0238).
7. Submission of applicable fee for revision of The firm has submitted Rs. 7,500/- for revision of
specifications as per notification No.F.7- specifications vide challan number 947937869.
11/2012-B&A/DRAP dated 07-05-2021.
8. Scientific justification how the results of at The results in raw data sheets are same for accelerated and
zero-month time point can be different for real time stability at initial time point whereas in stability
accelerated and real time conditions. summary sheets the results are different, it was a
typographical error. We are submitting revised stability
summary sheets.
 Capacity assessment of M/s Cunningham Pharmaceuticals Lahore was carried out on 12-11-2020 and
the report was presented in 297th meeting of Registration Board. As per the report, firm has 3 HPLC
systems and the reported available capacity in major areas is as under:
Sr. No Section Average Available capacity

1. HPLC 75.52%
2. Sterility testing 84.86 %
Decision: Registration Board noted the fact that since separate pharmacopoeial monograph is not
available for different grades of Cefixime i.e., micronized and compacted, thereby the submitted stability
studies of drug substance is acceptable hence Board approved the instant application.
 Manufacturer shall submit testing record of recently manufactured commercial batch as per USP
monograph before issuance of Registration Letter.
1059. Name, address of Applicant / Marketing M/s PDH Laboratories Pvt Ltd. 9.5 km,
Authorization Holder Sheikhupura Road, Lahore
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot
No. 81, Sunder Industrial Estate, Lahore.
☐ Importer
Cunningham Pharmaceuticals (Pvt) Ltd dated 19-
04-2019 based on the inspection dated 01-04-2019.
The GMP certificate specifies Dry powder
DML of M/s Cunningham Pharmaceuticals (Pvt)
Ltd dated 13-06-2016 specifying Dry powder
☐ Export sale
The proposed proprietary name / brand name PDFIM 200mg/5ml Dry Suspension
Pharmaceutical form of applied drug White to light yellow powder filled in amber colored
glass bottle
drug product.
30°C ± 2°C / 65 ± 5% RH for 36 months.
against Cebosh dry suspension of Bosch
pharmaceuticals.
API Lot No. 00243/342/2017
Description of Pack
Batch No. 180011 180016 180048
Batch Size 5,000 bottles 5,000 bottles 5,000 bottles
No. of Batches 03
1. Reference of previous approval of applications No previous PSI has been conducted
manufacturer issued by concerned regulatory by Additional Director DRAP, dated 11-01-2019.
dated 08-01-2019.
attested respective documents like chromatograms, along with raw data sheets, HPLC chromatograms,
Raw data sheets, COA, summary data sheets etc. COA and summary data sheets.
Evaluation by PEC:
Registration Board in its 320th meeting considered the case of Cefixime 200mg/5ml dry suspension
manufactured by M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot No. 81, Sunder Industrial Estate, Lahore
wherein the Board decided to defer for following points for which the response is tabulated below:
Sr. No Reasons for deferment Response by the firm

1. Scientific justification for having different The firm has submitted revised specifications for drug
specifications of the drug substance from that of substance as per B.P.
API manufacturer as well as BP monograph
2. Scientific justification how a revised method of The format of SOP For Cefixime was revised in February
February 2021 can represent the results of the 2021. However, the testing method was same as that of
stability studies which were initiated in March stability studies initiated in 2018. We didn’t change the
2018. testing method of API, only format was revised with new
revision number and date.
3. Scientific justification for performing The firm has stated that the verification studies were
verification studies of the analytical method of performed for analytical method as provided in the section
drug substance using a different analytical 3.2.S.4.2. Furthermore, the calculation method is also as
method from that specified in section 3.2.S.4.2. per B.P. The firm has submitted relevant chromatogram
and raw data sheets.
4. Submission of stability study data of three The firm has submitted stability study data of three batches
batches of cefixime trihydrate (micronized) (real time: 36 months : Accelerated : 06 months) according
from the API manufacturer as per zone IV-A to the conditions of Zone IV-A.
conditions. Batches: 00243/001/2018, 00243/100/2018,
00243/200/2018
5. Submission of pharmaceutical equivalence and Pharmaceutical equivalence and CDP studies have been
Comparative Dissolution Profile (CDP) against performed against Cefspan dry suspension mfg by M/s
the innovator’s product. Barret Hodgson. The firm has submitted the relevant data
including calculations of F2 values.
6. Submission of preservative effectiveness The firm has performed preservative effectiveness studies
studies. and presented the data in relevant section (document no.
SOP-MB/02-0238).
7. Submission of applicable fee for revision of The firm has not submitted any fee.
specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021.
8. Scientific justification how the results of at The results in raw data sheets are same for accelerated and
zero-month time point can be different for real time stability at initial time point whereas in stability
accelerated and real time conditions. summary sheets the results are different, it was a
typographical error. We are submitting revised stability
summary sheets.
 Capacity assessment of M/s Cunningham Pharmaceuticals Lahore was carried out on 12-11-2020 and
the report was presented in 297th meeting of Registration Board. As per the report, firm has 3 HPLC
systems and the reported available capacity in major areas is as under:

1. HPLC 75.52%
Decision: Approved.
1060. Name, address of Applicant / Marketing M/s Swat Pharmaceuticals, Saidu Sharif, Swat.
Authorization Holder
Name, address of Manufacturing site. M/s EG Pharmaceuticals, 13/A Industrial Triangle
Kahuta Road, Islamabad.
☐ Importer
GMP status of the firm Firm has submitted copy of inspection report of M/s
EG Pharmaceuticals dated 13-02-2019
recommending the renewal of DML.
DML (No. 000752) dated 29-08-2012 specifying
capsule (cephalosporin) section.
☐ Export sale
The proposed proprietary name / brand name SOXIME 400mg Capsule
Strength / concentration of drug of Active Each capsule Contains:
Pharmaceutical ingredient (API) per unit Cefixime (as trihydrate)………400mg
Pharmaceutical form of applied drug Sterile clear and colourless oily solution filled in
glass ampoules
Reference to Finished product specifications JP specification
The status in reference regulatory authorities Cefixime 400mg capsule (MHRA Approved)
For generic drugs (me-too status) Cefim Capsule by Hilton
Name and address of API manufacturer. Saakh Pharma (Pvt) Ltd. C-7/1, North Western
Industrial Zone, Port Qasim, Karchi.
drug product.
Stability Studies of Drug Substance Firm has submitted stability data of 3 batches of API
(Conditions & duration of Stability studies) at accelerated and real time conditions
Pharmaceutical Equivalence and Comparative Firm has also submitted results of comparative
Dissolution Profile dissolution profile of their product with Fixval
Capsule of M/s GSK. Firm has performed CDP in
0.1 N HCl, buffer pH 4.5 and phosphate buffer pH
6.8. Firm also calculated factor f2 which was above
50.
The firm has submitted results and comparison of
Fixval Capsule, manufactured by M/s GSK and Ficx
Capsule of M/s EG. Test results of this study found
satisfactory, comparable and within specifications.
product data.
Manufacturer of API SAAKH PHARMA (Pvt)Ltd C-7/1,NWIZ,Port Qasim Karachi

API Lot No. 8CF10131,18CF10111,18CF10039
Description of Pack
Alu-Alu blister in unit carton
Batch No. 961 990 933
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate 039/2019-DRAP (K)
manufacturer issued by concerned regulatory issued by the DRAP has been submitted. Which is
authority of country of origin. valid up to 03-01-2020
3. Documents for the procurement of API with N/A
approval from DRAP (in case of import). As API Purchased from Saakh Pharma (Pvt)Ltd
C-7/1,NWIZ, Port Qasim Karachi
4. Data of stability batches will be supported by Yes
attested respective documents like chromatograms,
Raw data sheets, COA, summary data sheets etc.
6. Record of Digital data logger for temperature and Yes
Evaluation by PEC:
Firm was issued letter of shortcomings with following points:
 The application for contract manufacturing from M/s EG Pharmaceuticals Islamabad is not submitted
as per the guidance document approved by Registration Board. The submitted application is in variation
to the guidance document in module 1 and various sections of module 3. The submitted COA of drug
substance, batch analysis report of drug product and stability study data of drug product is not in line
with the recommendations of Registration Board and as per the guidance document.
 The drug product testing has been carried out using specifications which are not in line with the
specifications of cefixime capsule approved by Registration Board, furthermore the firm has carried out
dissolution testing using UV method and the assay test during stability studies are also carried out using
a single chromatogram of standard and sample.
 Therefore, you are advised to resubmit your application compiled in the light of the guidance document
approved by Registration Board in which product development and stability studies has been conducted
as per the monograph approved by Registration Board and notified vide No.F.14-1/2022-PEC dated
14-03-2022 along with submission of requisite fee so that further evaluation of your application could
be carried out.
Firm has submitted that the same formulation of cefixime 400mg capsule manufactured by M/s EG
Pharmaceuticals have been approved by Registration Board in its 296th meeting as a case of “Request for
Change in Registration Status of Product from M/s Swat Pharmaceuticals to M/s Wahabsons Pharma (Pvt) Ltd.
Swat Through Contract Manufacturing at M/s EG Pharmaceuticals, Islamabad”.
Applicant firm M/s Wahab sons pharma Pvt Ltd 4km Buner Road Barikot Swat
Manufacturer firm EG Pharmaceuticals 13A Industrial Triangle, Kahuta road

Islamabad
Brand Name Soxime Capsules 400mg
Batch No. of drug product 961 (3500 Packs), 990 (4370 Packs), 933 (4000 Packs)
Case No. 1
Page number 2461-2463
1061.Name, address of Applicant / Marketing M/s Nortech Pharmaceuticals. Plot # 203,

Authorization Holder Sihala Industrial Triangle, Kahuta Road,
Islamabad.
Islamabad.
☐ Importer
dated 19-10-2020.
GMP status of the firm
specifying Capsule (Cephalosporin) section.
☐ Export sale
Dy. No. and date of submission Dy. No. 16050: 07-03-2019 (Form 5)
Dy. No. 24216: 07-03-2019 (Form 5-F)
The proposed proprietary name / brand name NORXIME 400mg Capsule
Pharmaceutical form of applied drug Sterile clear and colourless oily solution filled in
glass ampoules
product.
Stability Studies of Drug Substance
(Conditions & duration of Stability studies)
Module-III Drug Product:
Pharmaceutical Equivalence and Comparative
Dissolution Profile
Analytical method validation/verification of
product
API Lot No.
Description of Pack
Batch Size 500 ampoules 500 ampoules 500 ampoules
No. of Batches 03
1. Reference of previous approval of applications
3. Documents for the procurement of API with
4. Data of stability batches will be supported by
data sheets etc.
6. Record of Digital data logger for temperature and
Evaluation by PEC:
Firm has initially applied for contract manufacturing with Mediate Pharmaceuticals on Form 5 on 07-03-
2019. Later the firm on 02-09-2021 submitted Form 5F along with change of contract manufacturer to M/s
Cure Laboratories Islamabad without submission of fee.
 Submission of fee PKR 75,000/- for change of contract manufacturer from Mediate Pharmaceuticals
to Cure Laboratories.
 The application for contract manufacturing from M/s Cure Laboratories Islamabad is not submitted
as per the guidance document approved by Registration Board. The submitted application is in
variation to the guidance document in module 1 and various sections of module 3. The submitted
COA of drug substance, batch analysis report of drug product and stability study data of drug product
is not in line with the recommendations of Registration Board and as per the guidance document.
specifications of cefixime capsule approved by Registration Board, furthermore the firm has carried
out assay and dissolution testing using UV method while their own specifications specify HPLC
method for assay.
 Therefore, you are advised to resubmit your application compiled in the light of the guidance
document approved by Registration Board in which product development and stability studies has
been conducted as per the monograph approved by Registration Board and notified vide No.F.14-
1/2022-PEC dated 14-03-2022 along with submission of requisite fee so that further evaluation of
your application could be carried out.
Decision: Registration Board deferred the case for submission of reply to the above cited shortcomings
within six months.
1062.Name, address of Applicant / Marketing M/s TN Pharmaceuticals (Pvt) Ltd. Plot No.
Authorization Holder 264-C, Sunder Industrial Estate, Raiwind Road
Lahore.
Name, address of Manufacturing site. M/s TN Pharmaceuticals (Pvt) Ltd. Plot No. 264-
C, Sunder Industrial Estate, Raiwind Road Lahore.
☐ Importer
GMP status of the firm Firm has submitted copy of GMP certificate dated
22-03-2019 issued on the basis of inspection dated
01-03-2019.
Drug Manuacturing License (DML) dated 21-07-
2017 specifying Tablet (General) Section.
☐ Export sale
The proposed proprietary name / brand name PARATIN 500mg Tablet
Strength / concentration of drug of Active Each tablet contains:
Pharmaceutical ingredient (API) per unit Paracetamol ………500mg
Pharmaceutical form of applied drug white color round uncoated tablet
Pharmacotherapeutic Group of (API) Analgesic / antipyretic
The status in reference regulatory authorities Paracetamol IPCA 500mg Tablet by IPCA
Laboratories (MHRA Approved)
For generic drugs (me-too status) Panadol Tablet of M/s GSK Pakistan (Reg #
000817)
Name and address of API manufacturer. Citi Pharma (Pvt) Ltd., 3-Km Head Balloki Road,
Phool Nagar Kasur.
product.
Dissolution Profile equivalence for all the quality tests defined in BP
Panadol tablet of GSK.
reference product i.e. Panadol tablet of GSK.
Manufacturer of API Citi Pharma (Pvt) Ltd., 3-Km Head Balloki Road, Phool Nagar Kasur.
API Lot No. Not submitted
Description of Pack
Alu-Alu blister
Batch No. TRL-28 TRL-29 TRL-30
No. of Batches 03
manufacturer issued by concerned regulatory Not submitted
data sheets etc.
Evaluation by PEC:
 Provide verification studies of drug substance from drug product manufacturer.
 Provide COA of relevant batch of drug substance which is used in the manufacturing of batches of
drug product.
 Justify why qualitative composition is different from the reference product, or else submit drug-
excipient compatibility studies.
 Justify why the analytical procedures of the drug product are different from that specified in latest
edition of USP monograph. Furthermore, submit detailed analytical procedure instead of attaching
monograph of USP 29.
 Provide detailed analytical procedures and exact concentrations of sample solutions used to perform
verification studies.
 Provide batch analysis report in section 3.2.P.5.4 instead of attaching BMR.
 Provide COA of reference standard actually used in the analysis of drug substance and drug product.
 Justify significant change in assay from 106.31% to 99.89% in accelerated stability of Batch TRL-
28.
 Justify significant change in assay from 106.23% to 99.58% in accelerated stability of Batch TRL-
29.
 Justify why you have performed stability studies using HPLC analysis performed at different column
length, diameter and column temperature from that specified in USP monograph.
 Provide evidence of gradient HPLC system which is required as per USP monograph.
 Provide reference of previous approval of applications with stability study data of the firm (if any)
 Provide evidence of approval of API/ DML/GMP certificate of API manufacturer issued by
concerned regulatory authority of country of origin.
 Provide copy of commercial invoice for evidence of purchase of the drug substance.
 Provide compliance Record of HPLC software 21CFR & audit trail reports on product testing.
within six months.
1063.Name, address of Applicant / Marketing M/s Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25,
Authorization Holder Sector 20, K.I.A., Karachi
Name, address of Manufacturing site. M/s Liven Pharmaceuticals (Pvt) Ltd, 49-Km,
Lahore Multan Road, Lahore.
☐ Importer
Firm has submitted contract manufacturing
agreement dated 29-04-2021.
31-07-2019 based on the inspection dated 03-07-
2019.
Liquid Injection Ampoule (General) Section.
☐ Export sale
PKR 25,000/-: 07-06-2021
The proposed proprietary name / brand name ONDASET 4mg/2ml Injection
Strength / concentration of drug of Active Each 2ml ampoule contains:
Pharmaceutical ingredient (API) per unit Ondansetron (as HCl)………4mg
Pharmaceutical form of applied drug Clear colorless liquid filled in clear glass ampoule
Pharmacotherapeutic Group of (API) Antiemetic
The status in reference regulatory authorities (MHRA Approved)
For generic drugs (me-too status) Onseron Injection by Indus Pharma
Name and address of API manufacturer. M/s Cadila Pharmaceuticals Ltd. 294, G.I.D.C,
Estate, Ankleshwar District Bharuch Gujrat Estate,
India.
product.
Dissolution Profile
Manufacturer of API M/s Cadila Pharmaceuticals Ltd. 294, G.I.D.C, Estate, Ankleshwar District
Bharuch Gujrat Estate, India.
API Lot No. 180S002
Description of Pack
Glass ampoule
Batch No. ON1 ON2 ON3
Batch Size 25000 Ampoules 25000 Ampoules 25000 Ampoules
No. of Batches 03
manufacturer issued by concerned regulatory 18101065) issued by Food and Drugs Control
authority of country of origin. Administration Gujrat Estate India. The certificate
is valid till 18-10-2021.
approval from DRAP (in case of import). specifying purchase of 3Kg Ondansetron
hydrochloride cleared dated 16-04-2019. The
invoice is cleared by AD (I&E).
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has performed stability studies using UV
audit trail reports on product testing method.
Evaluation by PEC:
 Submit verification studies of the analytical method of drug substance in section 3.2.S.4.3.
 Provide stability studies of three batches of drug substance as per zone IV-A conditions.
 Your qualitative composition is different from that of the innovator product. Justification is required
in this regard.
 Innovator product has used ondansetron hydrochloride dehydrate while you are using ondansetron
hydrochloride. Justification is required in this regard.
 Provide details incuding batch number, exppiry date and manufacturer of the product against which
pharmaceutical equivalence studies are conducted, since Zofran 4mg/2ml injection is not registered
in Pakistan.
 Justify the UV method as alternate method in the analytical procedure for assay test of your product,
since no such test is specified in USP monograph.
 Justify the analytical method validation studies performed on UV method while USP as well as your
analytical procedure specifies HPLC test.
 Justify the performance of assay method using UV method which is contrary to the USP method for
your commercial batches.
 Provide reference of previous approval of applications with stability study data of the firm (if any) /
previous product specific inspection.
 Submit Batch Manufacturing Record of three stability batches.
within six months.
1064.Name, address of Applicant / Marketing M/s Aspin Pharma (Pvt) Ltd. Plot No. 10 & 25,
Authorization Holder Sector 20, K.I.A., Karachi
Name, address of Manufacturing site. M/s Liven Pharmaceuticals (Pvt) Ltd, 49-Km,
Lahore Multan Road, Lahore.
☐ Importer
Firm has submitted contract manufacturing
agreement dated 29-04-2021.
31-07-2019 based on the inspection dated 03-07-
2019.
Liquid Injection Ampoule (General) Section.
☐ Export sale
PKR 25,000/-: 07-06-2021
The proposed proprietary name / brand name ONDASET 8mg/4ml Injection
Pharmaceutical ingredient (API) per unit Ondansetron (as HCl)………8mg
Pharmaceutical form of applied drug Clear colorless liquid filled in clear glass ampoule
Pharmacotherapeutic Group of (API) Antiemetic
The status in reference regulatory authorities (MHRA Approved)
For generic drugs (me-too status) Onseron Injection by Indus Pharma
Name and address of API manufacturer. M/s Cadila Pharmaceuticals Ltd. 294, G.I.D.C,
Estate, Ankleshwar District Bharuch Gujrat Estate,
India.
product.
Dissolution Profile
Manufacturer of API M/s Cadila Pharmaceuticals Ltd. 294, G.I.D.C, Estate, Ankleshwar District
Bharuch Gujrat Estate, India.
API Lot No. 180S002
Description of Pack
Glass ampoule
Batch No. OT1 OT2 OT3
Batch Size 25000 Ampoules 25000 Ampoules 25000 Ampoules
No. of Batches 03
manufacturer issued by concerned regulatory 18101065) issued by Food and Drugs Control
authority of country of origin. Administration Gujrat Estate India. The certificate
is valid till 18-10-2021.
approval from DRAP (in case of import). specifying purchase of 3Kg Ondansetron
hydrochloride cleared dated 16-04-2019. The
invoice is cleared by AD (I&E).
data sheets etc.
5. Compliance Record of HPLC software 21CFR & Firm has performed stability studies using UV
audit trail reports on product testing method.
Evaluation by PEC:
 Submit verification studies of the analytical method of drug substance in section 3.2.S.4.3.
 Provide stability studies of three batches of drug substance as per zone IV-A conditions.
 Your qualitative composition is different from that of the innovator product. Justification is required
in this regard.
 Innovator product has used ondansetron hydrochloride dehydrate while you are using ondansetron
hydrochloride. Justification is required in this regard.
 Provide details incuding batch number, exppiry date and manufacturer of the product against which
pharmaceutical equivalence studies are conducted, since Zofran 4mg/2ml injection is not registered
in Pakistan.
 Justify the UV method as alternate method in the analytical procedure for assay test of your product,
since no such test is specified in USP monograph.
 Justify the analytical method validation studies performed on UV method while USP as well as your
analytical procedure specifies HPLC test.
 Justify the performance of assay method using UV method which is contrary to the USP method for
your commercial batches.
 Provide reference of previous approval of applications with stability study data of the firm (if any) /
previous product specific inspection.
 Submit Batch Manufacturing Record of three stability batches.
 Batch OT3 is manufactured on 06-2019 and placed on stability studies on 27-08-2019. Justification
is required in this regard.
within six months.
1065.Name, address of Applicant / Marketing M/s Farm Aid Group Pharmaceuticals, 3/2 Phase-I &
Authorization Holder II Hattar Industrial Estate Hattar, Haripur.
Name, address of Manufacturing site. M/s Cure Laboratories (Pvt) Ltd. Plot # 11-12, Street #
NS-2, RCCI Industrial Estate, Rawat Islamabad.
☐ Importer
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of Drug
Manufacturing License of M/s Cure Laboratories (Pvt)
Ltd dated 05-03-2019 specifying Capsule
☐ Export sale
The proposed proprietary name / brand name FOFAM 400mg Capsule
Pharmaceutical form of applied drug Sterile clear and colourless oily solution filled in glass
ampoules
drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for both drug substance
drug substance.
Dissolution Profile
product
API Lot No.
Description of Pack
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
data sheets etc.
Evaluation by PEC:
 The application for contract manufacturing from M/s Cure Laboratories Islamabad is not submitted as per
the guidance document approved by Registration Board. The submitted application is in variation to the
guidance document in module 1 and various sections of module 3. The submitted COA of drug substance,
batch analysis report of drug product and stability study data of drug product is not in line with the
recommendations of Registration Board and as per the guidance document.
assay and dissolution testing using UV method while their own specifications specify HPLC method for
assay.
approved by Registration Board in which product development and stability studies has been conducted as
per the monograph approved by Registration Board and notified vide No.F.14-1/2022-PEC dated 14-03-
2022 along with submission of requisite fee so that further evaluation of your application could be carried
out.
Decision: Registration Board deferred the case for submission of reply to the above cited shortcomings within
six months.
1066. Name, address of Applicant / Marketing M/s Nagarsons Pharmaceuticals. Plot No. 34, St.
Authorization Holder No. NS-2, National Industrial Zone, Rawat,
Islamabad
Name, address of Manufacturing site. M/s EG Pharmaceuticals, 13/A Industrial Triangle
Kahuta Road, Islamabad.
☐ Importer
GMP status of the firm Firm has submitted copy of inspection report of M/s
EG Pharmaceuticals dated 13-02-2019 recommending
the renewal of DML.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of issuance of DML
(No. 000752) dated 29-08-2012 specifying capsule
(cephalosporin) section.
☐ Export sale
The proposed proprietary name / brand name CEFINAG 400mg Capsule
ampoules
stability studies of drug substance and drug product.
substance.
Dissolution Profile
product
Manufacturer of API
API Lot No.
Description of Pack
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
1. Reference of previous approval of applications with
4. Data of stability batches will be supported by attested
respective documents like chromatograms, Raw data
sheets, COA, summary data sheets etc.
humidity monitoring of stability chambers (real time
and accelerated)
Evaluation by PEC:
 The application for contract manufacturing from M/s EG Pharmaceuticals Islamabad is not submitted as per
recommendations of Registration Board and as per the guidance document.
dissolution testing using UV method and the assay test during stability studies are also carried out using a
single chromatogram of standard and sample.
approved by Registration Board in which product development and stability studies has been conducted as
per the monograph approved by Registration Board and notified vide No.F.14-1/2022-PEC dated 14-03-
2022 along with submission of requisite fee so that further evaluation of your application could be carried
out.
six months.
1067. Name, address of Applicant / Marketing M/s Cherwel Pharmaceuticals (Pvt) Ltd. Plot No.
Authorization Holder 20, Phase 4, Hattar-Industrial Estate, KPK.
Name, address of Manufacturing site. M/s Bio-Labs (Pvt) Ltd. Plot No. 145, Industrial
☐ Importer
Firm has submitted notarized copy of contract
manufacturing agreement with applicant firm dated
21-04-2017.
Bio-Labs dated 21-05-2019 based on the inspection
2022.
The GMP certificate specifies liquid ampoule
(General) section.
Evidence of approval of manufacturing facility Firm has submitted copy of GMP certificate of M/s
2022.
The GMP certificate specifies liquid ampoule
(General) section.
Firm has also submitted copy of letter for grant of
additional section dated 23-07-2012 specifying
Ampoule (General) section.
☐ Export sale
The proposed proprietary name / brand name Sunray Injection 5mg/mL
Strength / concentration of drug of Active Each ampoule Contains:
Pharmaceutical ingredient (API) per unit Cholecalciferol………5mg
ampoules
Pharmacotherapeutic Group of (API) Vitamin
The status in reference regulatory authorities Cholecalciferol Injection (ANSM France Approved)
For generic drugs (me-too status) Novel-D Injection by Danas Pharma (Reg #073183)
Name and address of API manufacturer. Fermenta Biotech Limited. Village Takoli P.O.
Nagwain, Dist Mandi Himachal Pradesh India.
drug product.
substance.
(Conditions & duration of Stability studies) drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted
at 25°C ± 2°C / 60% ± 5% RH for 6 months. The real
time stability data is conducted at 5°C ± 3°C for 36
months.
against the comparator i.e. Novel-D Injection 5mg/ml.
product substance and validation studies of the drug product.
Manufacturer of API Sichuan Yuxin Pharmaceutical Co., Ltd. No. 51, West Section of Changjiang
Road, Shifang Economic Development Zone (South District) Shifang city,
Sichuan Province China.
API Lot No. B-1-51-M191210
Description of Pack
Glass ampoule
No. of Batches 03
1. Reference of previous approval of applications with Not submitted
2. Approval of API/ DML/GMP certificate of API Not submitted
humidity monitoring of stability chambers (real time temperature and humidity monitoring of real time and
and accelerated) accelerated stability chambers.
Evaluation by PEC:
 The application for contract manufacturing from M/s Bio-Labs (Pvt) Ltd. Islamabad is not submitted as per
recommendations of Registration Board and as per the guidance document. Furthermore, it is also
pertinent to mention that the drug product testing has been carried out using specifications which are not
in line with the recommendations of the general monographs of the official pharmacopoeia and the
analytical method of the assay test is based on UV method contrary to the method of analysis of the drug
substance manufacturer and the method of analysis specified in section 3.2.P.5.2.
approved by Registration Board and also justifying the specifications of the drug product so that further
evaluation of your application could be carried out.
In response, the firm has submitted stability study data of new batches manufactured using a different lot of API.
The evaluation of newly submitted data is as under:
Manufacturer of API Sichuan Yuxin Pharmaceutical Co., Ltd. No. 51, West Section of Changjiang
Road, Shifang Economic Development Zone (South District) Shifang city,
Sichuan Province China.
API Lot No. B-1-51-M180903
Description of Pack
Glass ampoule
Batch No. A-644 A-645 A-646
Batch Size 30,000 packs 30,000 packs 30,000 packs
No. of Batches 03
1. Reference of previous approval of applications with NA
manufacturer issued by concerned regulatory SC20160032) issued by CFDA China. The certificate
authority of country of origin. was valid till 17-11-2021.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice for
approval from DRAP (in case of import). import of Vitamin D3 API having lot number B-1-51-
M180903. The invoice is cleared by AD (I&E) dated
29-10-2018.
4. Data of stability batches will be supported by attested Firm has submitted copy of clearance certificate
respective documents like chromatograms, Raw data specifying import of 2.5Kg API dated 29-10-2018.
Evaluation by PEC:
proposed shelf life and on accelerated studies for six months as per the commitment submitted in
the registration application.
 Firm will submit 75,000/- fee for revision in stability data as per notification No.F.7-11/2012-
1068. Name, address of Applicant / Marketing M/s Albert Pharmaceuticals (Pvt) Ltd. Plot No.
Authorization Holder 127, Sundar Industrial Estate, Raiwind Road,
Lahore.
Name, address of Manufacturing site. M/s Himedic Pharmaceuticals (Pvt) Ltd. 19 Km Link
☐ Importer
04-05-2021.
Manufacturing License to M/s Himedic
Pharmaceuticals dated 05-08-2015. The letter
specifies dry powder for injection (cephalosporin)
section.
☐ Export sale
The proposed proprietary name / brand name ALZON Powder for Injection 250mg
Pharmaceutical form of applied drug Sterile white to off white powder filled in transparent
glass vials
Name and address of API manufacturer. Zhuhai United Laboratories Co. Ltd. No. 2428, Anji
Road, Sanzao Town, Jinwan District Zhuhai
Guangdong P.R China.
drug product.
substance.
against the comparator i.e. Rocephin 250mg
Injection.
Manufacturer of API Zhuhai United Laboratories Co. Ltd. No. 2428, Anji Road, Sanzao Town, Jinwan
District Zhuhai Guangdong P.R China.
API Lot No.
Description of Pack
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
3. Documents for the procurement of API with approval
from DRAP (in case of import).
and accelerated)
Evaluation by PEC:
 Specify whther the application is for Intravenous or intra muscular use.

 Provide valid GMP certificate / inspection report of the contract manufacturer as well as applicant firm.
 Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per the guidance document approved by Registration Board
which specifies that “Copies of the Drug substance specifications and analytical procedures used for routine
testing of the Drug substance /Active Pharmaceutical Ingredient by both Drug substance & Drug Product
 Submit data of verification of analytical procedure of drug substance in section 3.2.S.4.3 as per the guidance
document approved by Registration Board which specifies that “Analytical Method Verification studies
including specificity, accuracy and repeatability (method precision) performed by the Drug Product
manufacturer for both compendial as well as non-compendial drug substance(s) shall be submitted”.
 Provide COA of relevant batch of drug substace in section 3.2.S.4.4 used in the manufacturing of three
batches of drug product for which stability data is submitted.
 Submit COA of reference standard actually used in the analysis of drug substance in section 3.2.S.5.
 Submit stability study data of drug substance conducted as per zone IV-A conditions or else submit the
following as per the decision of 290th meeting of Registration Board:
o Record of data logger for the storage conditions throughout the transportation of drug substance.
o Real term stability studies data of the product for atleast 1 year along with degradation studies in
the finished pharmaceutical product.
 Justify your composition of drug product which specifies that the product contains ceftriaxone sodium
250mg while as per your label claim and innovator’s product, the product shall contain 250mg of ceftriaxone
as ceftriaxone sodium salt.
 The innovator product Rocephin Injection 250mg have specified that 2.4ml WFI is required to reconstitute
the injection for intravenous injection, while you are using 5ml WFI. Justify why you are not using the same
volume of diluent as specified by the innovator product.
 Justify the use of 5% overage in your commercially manufactured batches as well as during product
development studies.
 Submit data of pharmaceutical equivalence in section 3.2.P.2.2.1. as per the decision of 293rd meeting of
Registration Board, which states that “Pharmaceutical equivalence of the applied drug shall be established
with the innovator / reference / comparator product and results of all the quality tests (mentioned in any
official pharmacopoeia or section 3.2.P.5.1 of this application) of the developed formulation and the
innovator / reference / comparator product should be submitted and discussed.”
 You have specified sample solution 1 method in your assay test while is acceptance criteria is for sample
solution 2 method. Jutify this practice along with revision of specifications as per monograph and
submission of fee.
 USP monograph specifies two different sample solutions as well as two different analysis, calculation
formula and acceptance criteria for assay test, while your specifications does not specify two different tests
and acceptance criteria for assay and you have released your batches with only 1 type of assay results.
Justify why your specifications, analytical method and practices of batch release are not aligned with USP
monograph recommendations.
 Justify why the analytical procedure used in validation studies is different from that specified in your section
3.2.S.4.2.
 Validation studies are performed in 2021 while the stability study data is provided for batches of drug
product which were manufactured before 2021.
 Justify how a single validation studies are used for all strengths of ceftriaxone injection since USP
monograph specifies different analytical method for each strength.
 Provide batch release certificate of 3 batches of drug product in section 3.2.P.5.4 for which complete
stability study data is provided in section 3.2.P.8.3. Since you have submitted batch release of different
batches.
 Justify how you are using working standard from pharmagen while your drug substance source is Zhuhai
United Laboratories.
 Provide details in section 3.2.P.8.1 as per CTD guidance document since this section is not submitted.
 Provide summary sheets for stability studies data of 3 batches of drug product in section 3.2.P.8.3 as per the
format approved by the Board and presented in CTD guidance document since your reports are hand written
and not clearly visible and also does not provide information regarding particular lot number of the drug
substance used to manufacture this particular batch of drug product.
 Provide documents for the procurement of relevant lot(s) of API used in the manufacturing of 3 batches of
drug product for which stability studies data is submitted in section 3.2.P.8.3
 Submit stability study data in section 3.2.P.8.3 as per the checklist approved by Registration Board in its
296th meeting and the CTD guidance document, which includes the following:
o Reference of previous approval of applications with stability study data of the firm (if any)
o Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory
o Documents for the procurement of API with approval from DRAP (in case of import).
o Data of stability batches will be supported by attested respective documents like chromatograms,
o Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
o Record of Digital data logger for temperature and humidity monitoring of stability chambers (real
six months.
Lahore.
☐ Importer
04-05-2021.
section.
☐ Export sale
The proposed proprietary name / brand name ALZON Powder for Injection 500mg
glass vials
drug product.
substance.
Injection.
API Lot No.
Description of Pack
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
and accelerated)
Evaluation by PEC:

500mg while as per your label claim and innovator’s product, the product shall contain 500mg of ceftriaxone
as ceftriaxone sodium salt.
 Jutify the use of 5ml water for injection as a diluent for applied prouct in the line of innovator’s drug product.
submission of fee.
3.2.S.4.2.
batches.
six months.
Lahore.
☐ Importer
04-05-2021.
section.
☐ Export sale
The proposed proprietary name / brand name ALZON Powder for Injection 1g
glass vials
drug product.
substance.
Injection.
API Lot No.
Description of Pack
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
and accelerated)
Evaluation by PEC:

1000mg while as per your label claim and innovator’s product, the product shall contain 1000mg of
ceftriaxone as ceftriaxone sodium salt.
 Jutify the use of 10ml water for injection as a diluent for applied prouct in the line of innovator’s drug
product.
submission of fee.
3.2.S.4.2.
batches.
six months.
1071. Name, address of Applicant / Marketing M/s Genetics Pharmaceuticals (Pvt) Ltd. 539-A,
Authorization Holder Sunder Industrial Estate, Lahore.
Name, address of Manufacturing site. M/s Cunningham Pharmaceuticals (Pvt) Ltd. Plot No.
81, Sunder Industrial Estate, Lahore.
☐ Importer
Cunningham Pharmaceuticals dated 19-04-2019
based on the inspection dated 01-04-2019. The
certificate was valid till 01-04-2022.
The GMP certificate specifies dry powder injection
Manufacturing License to M/s Cunningham
specifies dry powder injection (cephalosporin)
section.
☐ Export sale
The proposed proprietary name / brand name GENXONE Dry Powder Injection 250mg (IV)
glass vials
drug product.
substance.
(Conditions & duration of Stability studies) drug substance at both accelerated as well as real time
conditions. The accelerated stability data is conducted
at 40oC ± 2oC / 75% ± 5% RH for 6 months. The real
time stability data is conducted at 30oC ± 2oC / 65% ±
5% RH for 36 months.
Injection.
API Lot No. 3051805046
Description of Pack
Glass vials
Batch No. 180054 180075 180087
No. of Batches 03
manufacturer issued by concerned regulatory GD20180909) issued by CFDA China. The certificate
authority of country of origin. is valid till 05-12-2023
3. Documents for the procurement of API with approval Firm has submitted copy of commercial invoice cleared
from DRAP (in case of import). dated 03-07-2018 specifying import of 80Kg
ceftriaxone sodium sterile (USP). The invoice is
cleared by AD (I&E) DRAP.
4. Data of stability batches will be supported by attested Not submitted
5. Compliance Record of HPLC software 21CFR & Firm has submitted that their HPLC system is not 21
audit trail reports on product testing CFR compliant.
Evaluation by PEC:

1. Provide valid GMP certificate / inspection report of The firm has submitted last inspection report dated
the contract manufacturer since the submitted GMP 01/04/2019. The firm has maintained conformance to
certificate has been expired. GMP compliance in manufacturing and QC operations.
2. Submit module 1 as per the CTD guidance document Module I is submitted as per CTD guidance document.
approved by Registration Board by providing all the
information and documents in relevant sections / sub-
sections instead of referring to annexures.
3. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per Copies of the drug substance specifications and analytical
the guidance document approved by Registration procedures used for routine testing of drug substance by
Board which specifies that “Copies of the Drug both drug product and drug substance manufacturer in the
substance specifications and analytical procedures relevant sections as per guidance document for Form 5F.
used for routine testing of the Drug substance /Active
Pharmaceutical Ingredient by both Drug substance &
Drug Product manufacturer is required.”
4. Provide details of the analytical method and The firm has submitted analytical method verification
concentrations in terms of mg/ml used to test the studies (including specificity, precision and accuracy etc)
parameters in verification / validation studies of the with the detail of concentrations of different dilutions
drug substance. Further justify significant difference used to test the parameters of required studies.
in peak areas value at same concentration during Furthermore, different analyst were involve in the said
different tests like precision and accuracy/linearity. testing therefore the results are not exactly the same.
5. Justify why the test of specificity is not performed The firm has submitted analytical method verification
during the verification / validation studies of the drug report mentioning the results of the test for specificity
substance. parameter for analytical method verification studies for
dug substance performed by drug product manufacturer.
6. The commercial invoice specifying ceftriaxone It was a typographical error, the drug substance was
sodium sterile (USP) having batch number received on 05/07/2018 and tested on 13/07/2018.
3051805046 was cleared by AD (I&E) DRAP Lahore
on 03-07-2018, while as per the certificate of analysis
of raw material from Cunningham Pharmaceuticals,
the material of same batch number was received on
05-01-2018 and was tested on 13-01-2018.
7. Submit COA of reference standard actually used in Certificate of analysis of reference standard actually used
the analysis of drug substance in section 3.2.S.5. in the development of the applied product is provided.
8. Justify how 300mg ceftriaxone sodium sterile The firm has submitted revised calculation for potency
powder is equivalent to 250mg of ceftriaxone base. adjustment considering the assay value of drug substance
and stated that the calculations for potency adjustment
will be made in future according to the assay value of the
drug substance for commercial batches.
9. The innovator product Rocephin Injection 250mg The firm has stated that the volume of diluent used was
have specified that 2.4ml WFI is required to exactly 2.4mL as recommended by the innovator’s
reconstitute the injection for intravenous injection, product. In the submitted data the volume used is 5mL
while you are using 5ml WFI. Justify why you are not which is a typographical error.
using the same volume of diluent as specified by the
innovator product.
10. You have specified that pharmaceutical equivalence The firm has submitted pharmaceutical equivalence data
studies was performed against Rocephin 250mg agaisnt Oxidil 250mh injection mfg by Sami
injection of Martin Dow Limited, while Rocephin Pharmaceuticals by performing all the quality tests.
250mg Injection is not registered in Pakistan. Pharamcetuical equivalence against the other strengths of
Justification is required in this regard. Ceftriaxone was performed against Rocephin and the
data of ther strength was placed mistakenly in the dossier.
11. Provide details of sample solution 2 preparation i.e. Detail of preparation of sample solution II is provided in
exact volume of water required for initial constitution the relevant section which is in-lined with USP for the
of the ceftriaxone for injection. applied product.
12. Your analytical method for drug product specifies Specifications of finished product has been revised with
two different sample solutions as well as two addition of acceptance criteria for assay as per USP
different analysis, calculation formula and monograph. Revised specifications are submitted which
acceptance criteria as per USP monograph, while are in-lined with USP.
your specifications does not specify two different The firm has stated that they have performed one test at
tests and acceptance criteria for assay and you have the stage of drug substance analysis and the other test is
released your batches with only 1 type of assay performed at the drug product stage.
results. Justify why your specifications, analytical “as we are dealing with the toll manufacturing in order
method and practices of batch release are not aligned for better understanding on COA we opted the 90-115%
with USP monograph recommendations. assay specifications. However, we have revised the SOP
along with the specifications and would update and
align all the practices and documents”.
13. Certificate of analysis of finished product for batch It was a typographical error. We are submitted the COA
number 180054 and batch number 180075 have same for 180054 and 180075 having actual values for all the
results for all the tests. Justification is required in this tests.
regard.
14. Batch number 180075 was manufactured in 11-2018 Due to typographical error, the date of release was
and its analysis was performed on 31-11-2018 while mentioned as 19/09/2018. However, we are submitted the
the batch was released on 19-09-2018. Justification complete data for your convenience related to testing and
is required in this regard. release of the batch.
15. Provide date of initiation and date of testing at each Submitted.
time point for every batch during stability studies.
16. Justify why the test for water contents, constituted We were not performing these tests in our stability
solution etc is not performed during stability studies testing. Whereas these tests were part of our routine
since these tests are very critical and are required to testing.
make assessment of the stability profile and shelf life. The firm has performed water content determination test
and submitted that relevant data.
17. Justify how the results of assay and pH of each batch Results of assay and pH at initial time point are not
is different at initial time point for accelerated and different. This was a typographical error. We are
real time stability study. The results of assay test at submitting revised summary sheets with correct value of
initial time point for each batch is different in assay and pH.
stability summary sheet and raw data sheets.
18. Provide 6 months stability study data of three batches The firm has submitted the stability study data as per the
along with HPLC chromatograms and raw data guidance document available on the official website of
sheets in a proper sequence and with separators as per DRAP.
the guidelines of registration Board for further
evaluation.
19. Stability study data of initial time point is not The firm has submitted the required data alongwith raw
submitted for any batch along with stability studies. data sheets and chromatograms.
20. Submit stability study data in section 3.2.P.8.3 as The firm has submitted stability study data in section
per the checklist approved by Registration Board in 3.2.P.8.3 as per the checklist approved by Registration
its 296th meeting and the CTD guidance document, Board.
which includes the following:  Lenzeu 30mg and 60mg Capsule (Dexlansoprazol)
o Reference of previous approval of applications approved in 297th meeting. & Tazipera 45g injection
with stability study data of the firm (if any) approved in 316th meeting.
o Approval of API/ DML/GMP certificate of API  Copy of GMP certificate No. GD20180909 valid till
manufacturer issued by concerned regulatory 05/12/2023, M/s Zhuhai United Laboratories Co., Ltd.,
authority of country of origin. issued by CFDA.
o Documents for the procurement of API with  Firm has submitted copy of commercial invoice cleared
o Data of stability batches will be supported by ceftriaxone sodium sterile (USP). The invoice is
attested respective documents like cleared by AD (I&E) DRAP.
chromatograms, Raw data sheets, COA, summary  Raw data sheet sand chromatograms have been
data sheets etc. submitted by the firm.
o Compliance Record of HPLC software 21CFR &  The firm has submitted record of digital data logger for
audit trail reports on product testing. accelerated and real time stability studies in the relevant
o Record of Digital data logger for temperature and section.
humidity monitoring of stability chambers (real  Compliance record of HPLC & audit trails are
time and accelerated) submitted.
 Capacity assessment of M/s Cunningham Pharmaceuticals Lahore was carried out on 12-11-2020 and the report
was presented in 297th meeting of Registration Board. As per the report, firm has 3 HPLC systems and the reported
available capacity in major areas is as under:

1. HPLC 75.52%
Decision: Approved.
 Manufacturer will perform process validation of first three batches as per the commitment submitted
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name GENXONE Dry Powder Injection 250mg (IM)
glass vials
drug product.
substance.
Injection.
API Lot No. 3051805046
Description of Pack
Glass vials
Batch No. 180054 180075 180087
No. of Batches 03
ceftriaxone sodium sterile (USP). The invoice is cleared
by AD (I&E) DRAP.
Evaluation by PEC:

1. Provide valid GMP certificate / inspection report The firm has submitted last inspection report dated
of the contract manufacturer since the submitted 01/04/2019. The firm has maintained conformance to GMP
GMP certificate has been expired. compliance in manufacturing and QC operations.
2. Submit module 1 as per the CTD guidance Module I is submitted as per CTD guidance document.
document approved by Registration Board by
3. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as Copies of the drug substance specifications and analytical
per the guidance document approved by procedures used for routine testing of drug substance by both
Registration Board which specifies that “Copies drug product and drug substance manufacturer in the relevant
of the Drug substance specifications and sections as per guidance document for Form 5F.
analytical procedures used for routine testing of
the Drug substance /Active Pharmaceutical
4. Provide details of the analytical method and The firm has submitted analytical method verification studies
concentrations in terms of mg/ml used to test the (including specificity, precision and accuracy etc) with the
parameters in verification / validation studies of detail of concentrations of different dilutions used to test the
the drug substance. Further justify significant parameters of required studies.
difference in peak areas value at same
concentration during different tests like precision
and accuracy/linearity.
5. Justify why the test of specificity is not The firm has submitted analytical method verification report
performed during the verification / validation mentioning the results of the test for specificity parameter for
studies of the drug substance. analytical method verification studies for dug substance
performed by drug product manufacturer.
6. The commercial invoice specifying ceftriaxone The firm has stated that separate batches of drug substance
sodium sterile (USP) having batch number were used or manufacturing of different strengths.
3051805046 was cleared by AD (I&E) DRAP
Lahore on 03-07-2018, while as per the Firm has submitted copy of commercial invoice cleared
certificate of analysis of raw material from dated 19/11/2021 vide dy.no. 17452/2021-DRAP. The
Cunningham Pharmaceuticals, the material of invoice is cleared by AD (I&E) DRAP.
same batch number was received on 05-01-2018
and was tested on 13-01-2018. Justification is
7. Submit COA of reference standard actually used Certificate of analysis of reference standard actually used in
in the analysis of drug substance in section the development of the applied product is provided.
3.2.S.5.
8. Justify how same results of pharmaceutical The firm has submitted pharmaceutical equivalence against
equivalence are produced for ceftriaxone 250mg Oxidil 250mg injection mfg by M/s Sami Pharmaceuticals by
IM and IV injection. performing all the quality tests.
9. Justify how 300mg ceftriaxone sodium sterile
powder is equivalent to 250mg of ceftriaxone
base.
10. Justify how you have manufactured batch The firm has submitted complete batch manufacturing record
number 200076 for axitrim 250mg IM as well as for 250mg IM injection for 3 batches along with the complete
IV while both products have seprate registration stability studies with the detail analytical method and other
numbers and have different analytical method for relevant documents.
analysis.
11. You have specified that pharmaceutical The firm has submitted Pharmaceutical equivalence data
equivalence studies was performed against against Oxidil 250mg Injecciton (Batch number : 014H mfg
Rocephin 250mg injection of Martin Dow by M/s Sami Pharma) by performing quality tests.
Limited, while Rocephin 250mg Injection is not
registered in Pakistan. Justification is required in
this regard.
12. Justify how compatibility studies of IV injection The firm has submitted compatibility studies for 250mg IM
can be used for ceftriaxone IM injection as well injection with the recommended diluent. The data is
presented in the relevant section (0H, 4H, 8H & 16H).
13. Provide details of sample solution 2 preparation Detail of preparation of sample solution II is provided in the
i.e. exact volume of water required for initial relevant section which is in-lined with USP for 250mg IM
constitution of the ceftriaxone for injection. injection.
14. Your analytical method for drug product Specifications of finished product has been revised with
specifies two different sample solutions as well addition of acceptance criteria for assay as per USP
as two different analysis, calculation formula and monograph. Revised specifications are submitted which are
acceptance criteria as per USP monograph, while in-lined with USP.
your specifications does not specify two different The firm has stated that they have performed one test at the
tests and acceptance criteria for assay and you stage of drug substance analysis and the other test is
have released your batches with only 1 type of performed at the drug product stage.
assay results. Justify why your specifications, “as we are dealing with the toll manufacturing in order for
analytical method and practices of batch release better understanding on COA we opted the 90-115% assay
are not aligned with USP monograph specifications. However, we have revised the SOP along with
recommendations. the specifications and would update and align all the
practices and documents”.
15. Justify how you are releasing commercial batches Data of 250mg IM injection has been submitted with separate
of ceftriaxone 250mg IM and IV as a single batch COAs. Certificate of Analysis of finished products are
by producing two COA having exactly same attached in executed BMRS of three batches enclosed in
results for each test. module 3 section 3.2.R.
16. Justify how Batch number 180054, 180075 and The firm has submitted stability summary sheets for 250mg
180087 submitted for IV injection are also used IM injection along with the relevant chromatograms and raw
for IM injection. data sheets. The firm has stated that the data of 250mg IV
injection was placed in 250mgIV dossier mistakenly.
17. Justify how single BMR can be used for a single Separate BMRs for 250mg ceftriaxone IM injection is
batch of two separately registered products like submitted in section 3.2.R.1.2 along with the blank template
ceftriaxone 250mg IM and 250mg IV Injection. of BM. The firm has submitted that the BMR were placed in
250mg IM injection mistakenly in the dossier on 250mg IV
injection.
18. Submit product development and stability study The firm has submitted product development and stability
data of 3 batches of ceftriaxone 250mg IM study data of 3 batches of Ceftriaxone 250mg IM Injection
injection for further evaluation. along with the raw data sheets chromatograms, COAs etc.

1. HPLC 75.52%
Decision: Approved.
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name GENXONE Dry Powder Injection 500mg (IV)
glass vials
drug product.
substance.
Injection.
API Lot No. 3051805046
3051805005
Description of Pack
Glass vials
Batch No. 180004 180019 180040
No. of Batches 03
Evaluation by PEC:

1. Provide valid GMP certificate / inspection report of The firm has submitted last inspection report dated
the contract manufacturer since the submitted GMP 01/04/2019. The firm has maintained conformance to
certificate has been expired. GMP compliance in manufacturing and QC operations.
2. Submit module 1 as per the CTD guidance document Module I is submitted as per CTD guidance document.
approved by Registration Board by providing all the
information and documents in relevant sections /
sub-sections instead of referring to annexures.
3. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per Copies of the drug substance specifications and
the guidance document approved by Registration analytical procedures used for routine testing of drug
Board which specifies that “Copies of the Drug substance by both drug product and drug substance
substance specifications and analytical procedures manufacturer in the relevant sections as per guidance
used for routine testing of the Drug substance /Active document for Form 5F.
Pharmaceutical Ingredient by both Drug substance &
Drug Product manufacturer is required.”
parameters in verification / validation studies of the with the detail of concentrations of different dilutions
drug substance. Further justify significant difference used to test the parameters of required studies.
in peak areas value at same concentration during
different tests like precision and accuracy/linearity.
5. The commercial invoice specifying ceftriaxone It was a typographical error. COA after correction is
sodium sterile (USP) having batch number attached in 3.2.S.4.4.
3051805046 was cleared by AD (I&E) DRAP Receiving date: 07/07/2018
Lahore on 03-07-2018, while as per the certificate of Test date: 13/07/2018
analysis of raw material from Cunningham
Pharmaceuticals, the material of same batch number
was received on 05-01-2018 and was tested on 13-
01-2018. Justification is required in this regard
6. Zee-inject (Water for injection (WFI) is used as a diluent
Provide details of diluent which is used to perform for reconstitution of drug product. The reconstituted
compatibility studies of drug product. product is yellowish clear solution. COA of diluent is
attached in Module 3 section
3.2.P.1(c)Description of accompanying reconstitution
diluent.
7. Justify why the test of specificity is not performed The firm has submitted analytical method verification
during the verification / validation studies of the drug report mentioning the results of the test for specificity
substance. parameter for analytical method verification studies for
8. Submit COA of reference standard actually used in Certificate of analysis of reference standard actually used
the analysis of drug substance in section 3.2.S.5. in the development of the applied product is provided.
9. Provide details of sample solution 2 preparation i.e. Detail of preparation of sample solution II is provided
exact volume of water required for initial in the relevant section which is in-lined with USP for
constitution of the ceftriaxone for injection. the applied product.
10. Your analytical method for drug product specifies Specifications of finished product has been revised with
two different sample solutions as well as two addition of acceptance criteria for assay as per USP
different analysis, calculation formula and monograph. Revised specifications are submitted which
acceptance criteria as per USP monograph, while are in-lined with USP.
your specifications does not specify two different The firm has stated that they have performed one test at
tests and acceptance criteria for assay and you have the stage of drug substance analysis and the other test is
released your batches with only 1 type of assay performed at the drug product stage.
results. Justify why your specifications, analytical “as we are dealing with the toll manufacturing in order
method and practices of batch release are not aligned for better understanding on COA we opted the 90-115%
with USP monograph recommendations. assay specifications. However, we have revised the SOP
along with the specifications and would update and
align all the practices and documents”.
11. Batch 180004 was manufactured on 01/2018 while Batch # 180004 was released on 25-01-2018.But
stability was initiated on 12-05-2018. Justification is unfortunately; due to unavailability of packaging
required in this regard. material (Unit cartons) the packing of this batch had
Batch 180019 was manufactured in May 2018 using faced some delay. That’s why stability was initiated in
drug substance lot number 3051805046 which was 12-05-2018.
imported and cleared in July 2018. Justification is Invoice for Batch # 180019 and Batch # 180004 was
required in this regard. missing during file compilation. Import invoice is
Batch 180004 was manufactured in January 2018 attached in Module 3 section 3.2.P.8.3. COA of drug
using drug substance lot number 3051805005 which substance is attached in Module 3 section 3.2.S.4.4.
was imported and cleared in July 2018. Justification Invoice for Batch # 180019 and Batch # 180004 was
is required in this regard. missing during file compilation. Import invoice is
attached in Module 3 section 3.2.P.8.3. COA of drug
substance is attached in Module 3 section 3.2.S.4.4.
12. Justify why the test for water contents, constituted We were not performing these tests in our stability
solution etc is not performed during stability studies testing. Whereas these tests were part of our routine
since these tests are very critical and are required to testing.
make assessment of the stability profile and shelf The firm has performed water content determination test
life. and submitted that relevant data.
13. Justify how the results of assay and pH of each batch Results of assay and pH at initial time point are not
is different at initial time point for accelerated and different. This was a typographical error. We are
real time stability study. The results of assay test at submitting revised summary sheets with correct value of
initial time point for each batch is different in assay and pH.
stability summary sheet and raw data sheets.
14. Provide 6 months stability study data of three batches The firm has submitted 6 months stability data (including
along with HPLC chromatograms and raw data accelerated and real time) of three batches along with the
sheets in a proper sequence and with separators as relevant chromatograms, raw data sheets etc as per the
per the guidelines of registration Board for further guidelines of Registration Board.
evaluation.
15. Stability study data of initial time point is not The firm has submitted the required data alongwith raw
submitted for any batch along with stability studies. data sheets and chromatograms.
16. Submit stability study data in section 3.2.P.8.3 as The firm has submitted stability study data in section
per the checklist approved by Registration Board in 3.2.P.8.3 as per the checklist approved by Registration
its 296th meeting and the CTD guidance document, Board.
which includes the following:  Lenzeu 30mg and 60mg Capsule (Dexlansoprazol)
o Reference of previous approval of applications approved in 297th meeting. & Tazipera 45g injection
with stability study data of the firm (if any) approved in 316th meeting.
o Approval of API/ DML/GMP certificate of API  Copy of GMP certificate No. GD20180909 valid till
manufacturer issued by concerned regulatory 05/12/2023, M/s Zhuhai United Laboratories Co., Ltd.,
authority of country of origin. issued by CFDA.
o Documents for the procurement of API with  Firm has submitted copy of commercial invoice cleared
o Data of stability batches will be supported by ceftriaxone sodium sterile (USP). The invoice is
attested respective documents like cleared by AD (I&E) DRAP.
chromatograms, Raw data sheets, COA, summary  Raw data sheet sand chromatograms have been
data sheets etc. submitted by the firm.
o Compliance Record of HPLC software 21CFR &  The firm has submitted record of digital data logger for
audit trail reports on product testing. accelerated and real time stability studies in the
o Record of Digital data logger for temperature and relevant section.
humidity monitoring of stability chambers (real  Compliance record of HPLC & audit trails are
time and accelerated) submitted.

1. HPLC 75.52%
Decision: Approved.
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name GENXONE Dry Powder Injection 1g (IV)
glass vials
drug product.
substance.
against the comparator i.e. Rocephin 1g Injection.
Manufacturer of API Sinopharm Weiqida Pharmaceutical Co. Ltd. First Medical Zone, Economic and
Technological Development Zone, Datong Shanxi. China
API Lot No. 3051805046
3051805005
Description of Pack
Glass vials
Batch No. 180003 180017 180018
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate (No. SX20180229) issued by
manufacturer issued by concerned regulatory CFDA China is submitted by the firm. The certificate
authority of country of origin. is valid till 05-06-2023.
3. Documents for the procurement of API with Firm has submitted copy of commercial invoice cleared
Evaluation by PEC:

1. Provide valid GMP certificate / inspection The firm has submitted last inspection report dated 01/04/2019.
report of the contract manufacturer since the The firm has maintained conformance to GMP compliance in
submitted GMP certificate has been expired. manufacturing and QC operations.
providing all the information and documents
in relevant sections / sub-sections instead of
3. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 Copies of the drug substance specifications and analytical
as per the guidance document approved by procedures used for routine testing of drug substance by both
Registration Board which specifies that drug product and drug substance manufacturer in the relevant
“Copies of the Drug substance specifications sections as per guidance document for Form 5F.
required.”
concentrations in terms of mg/ml used to test (including specificity, precision and accuracy etc) with the detail
the parameters in verification / validation of concentrations of different dilutions used to test the
studies of the drug substance. Further justify parameters of required studies.
significant difference in peak areas value at
same concentration during different tests like
precision and accuracy/linearity.
5. Justify use of drug substance from For manufacturing of already registered product Axitrim
Sinopharm Weiqida Pharmaceutical Co. Ltd injeciton 1g IV of M/s Cunningham, the drug substance was
for the applied strength, since you have purchase from M/s Sinopharm Weiqida Pharmaceuticals.
claimed drug substance source from Zhuhai Further demand for active material was placed but due to
United Laboratories Co. Ltd in other unavailability of active material from sinopharm we decided to
strengths of the same product. change the manufacturer to Zhuhai United and developed our
products using the material from Zhuhai united.
7. Submit COA of reference standard actually Certificate of analysis of reference standard actually used in the
used in the analysis of drug substance in development of the applied product is provided.
section 3.2.S.5.
8. Provide details of sample solution 2 Detail of preparation of sample solution II is provided in the
preparation i.e. exact volume of water relevant section which is in-lined with USP for the applied
required for initial constitution of the product.
ceftriaxone for injection.
9. Your analytical method for drug product Specifications of finished product has been revised with addition
specifies two different sample solutions as of acceptance criteria for assay as per USP monograph. Revised
well as two different analysis, calculation specifications are submitted which are in-lined with USP.
formula and acceptance criteria as per USP The firm has stated that they have performed one test at the stage
monograph, while your specifications does of drug substance analysis and the other test is performed at the
not specify two different tests and acceptance drug product stage.
criteria for assay and you have released your “as we are dealing with the toll manufacturing in order for
batches with only 1 type of assay results. better understanding on COA we opted the 90-115% assay
Justify why your specifications, analytical specifications. However, we have revised the SOP along with
method and practices of batch release are not the specifications and would update and align all the practices
aligned with USP monograph and documents”.
recommendations.
10. Provide date of initiation and date of testing Batch No.: 180003 initiated on 12/04/2018
at each time point for every batch during Batch No.: 180017 initiated on 28/06/2018
stability studies. Batch No.: 180018 initiated on 07/06/2018
11. Justify why the test for water contents, We were not performing these tests in our stability testing.
constituted solution etc is not performed Whereas these tests were part of our routine testing.
during stability studies since these tests are The firm has performed water content determination test and
very critical and are required to make submitted that relevant data.
assessment of the stability profile and shelf
life.
12. Justify how the results of assay and pH of Results of assay and pH at initial time point are not different.
each batch is different at initial time point for This was a typographical error. We are submitting revised
accelerated and real time stability study. The summary sheets with correct value of assay and pH.
results of assay test at initial time point for
each batch is different in stability summary
sheet and raw data sheets. Justification is
13. Provide 6 months stability study data of three The firm has submitted 6 months stability data (including
batches along with HPLC chromatograms accelerated and real time) of three batches along with the
and raw data sheets in a proper sequence and relevant chromatograms, raw data sheets etc as per the
with separators as per the guidelines of guidelines of Registration Board.
registration Board for further evaluation.
14. Stability study data of initial time point is not The firm has submitted the required data alongwith raw data
submitted for any batch along with stability sheets and chromatograms.
studies.
15. Submit stability study data in section The firm has submitted stability study data in section 3.2.P.8.3
3.2.P.8.3 as per the checklist approved by as per the checklist approved by Registration Board.
Registration Board in its 296th meeting and  Lenzeu 30mg and 60mg Capsule (Dexlansoprazol) approved
the CTD guidance document, which in 297th meeting. & Tazipera 45g injection approved in 316 th
includes the following: meeting.
o Reference of previous approval of  Copy of GMP certificate No. GD20180909 valid till
applications with stability study data of 05/12/2023, M/s Zhuhai United Laboratories Co., Ltd., issued
the firm (if any) by CFDA.
o Approval of API/ DML/GMP certificate  Firm has submitted copy of commercial invoice cleared dated
of API manufacturer issued by concerned 28-05-2020 specifying import of 100Kg ceftriaxone sodium
regulatory authority of country of origin. sterile (USP). The invoice is cleared by AD (I&E) DRAP.
o Documents for the procurement of API  Raw data sheet sand chromatograms have been submitted by
with approval from DRAP (in case of the firm.
import).  The firm has submitted record of digital data logger for
o Data of stability batches will be supported accelerated and real time stability studies in the relevant
by attested respective documents like section.
chromatograms, Raw data sheets, COA,  Compliance record of HPLC & audit trails are submitted.
o Compliance Record of HPLC software
testing.
o Record of Digital data logger for
stability chambers (real time and
accelerated)

1. HPLC 75.52%
Decision: Approved.
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name GENXONE Dry Powder Injection 1g (IM)
glass vials
drug product.
substance.
Manufacturer of API Sinopharm Weiqida Pharmaceutical Co. Ltd. First Medical Zone, Economic and
Technological Development Zone, Datong Shanxi. China
API Lot No. 3051805046
3051805005
Description of Pack
Glass vials
Batch No. 180003 180017 180018
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate (No. SX20180229) issued by
manufacturer issued by concerned regulatory CFDA China is submitted by the firm. The certificate
authority of country of origin. is valid till 05-06-2023.
Evaluation by PEC:

1. Provide valid GMP certificate / inspection The firm has submitted last inspection report dated
report of the contract manufacturer since the 01/04/2019. The firm has maintained conformance to GMP
submitted GMP certificate has been expired. compliance in manufacturing and QC operations.
per the guidance document approved by procedures used for routine testing of drug substance by both
Registration Board which specifies that drug product and drug substance manufacturer in the relevant
“Copies of the Drug substance specifications sections as per guidance document for Form 5F.
required.”
concentrations in terms of mg/ml used to test (including specificity, precision and accuracy etc) with the
the parameters in verification / validation detail of concentrations of different dilutions used to test the
studies of the drug substance. Further justify parameters of required studies.
significant difference in peak areas value at
same concentration during different tests like
5. Justify use of drug substance from Sinopharm For manufacturing of already registered product Axitrim
Weiqida Pharmaceutical Co. Ltd for the applied injeciton 1g IV of M/s Cunningham, the drug substance was
strength, since you have claimed drug purchase from M/s Sinopharm Weiqida Pharmaceuticals.
substance source from Zhuhai United Further demand for active material was placed but due to
Laboratories Co. Ltd in other strengths of the unavailability of active material from sinopharm we decided
same product. to change the manufacturer to Zhuhai United and developed
our products using the material from Zhuhai united.
7. Submit COA of reference standard actually The firm ha ssubmitted COA of the relevant batch of drug
used in the analysis of drug substance in section substance which was used in product development from drug
3.2.S.5. product and drug substance manfuactruer.
8. Submit COA of reference standard actually Certificate of analysis of reference standard actually used in
used in the analysis of drug substance in section the development of the applied product is provided.
3.2.S.5.
9. You have specified that diluent for this product The firm has stated that the volume of diluent that is
is 2ml lignocaine injection while the lignocaine was exactly the same as used by the innovator.
innovator’s product recommend use of 2.1 or
3.6ml of diluent.
10. Justify how compatibility studies of IV The firm has submitted compatibility studies of the product
injection can be used for ceftriaxone IM with the recommended diluent that is Lignocaine for IM
injection as well injection.
11. Justify how single BMR can be used for a single The firm has submitted complete batch manufacturing record
batch of two separately registered products like for the applied formulation and has stated that the BMD of IV
ceftriaxone 1g IM and 1g IV Injection. injection was placed in the dossier, mistakenly.
12. Submit product development and stability study The firm has submitted product development along with the
data of 3 batches of ceftriaxone 1g IM injection stability study data including accelerated and real time
for further evaluation. stability studies of 3 batches along with the relevant
chromatograms and raw data sheets.
13. Provide details of sample solution 2 preparation Detail of preparation of sample solution II is provided in the
i.e. exact volume of water required for initial relevant section which is in-lined with USP for the applied
constitution of the ceftriaxone for injection. product.
as two different analysis, calculation formula monograph. Revised specifications are submitted which are
and acceptance criteria as per USP monograph, in-lined with USP.
while your specifications does not specify two The firm has stated that they have performed one test at the
different tests and acceptance criteria for assay stage of drug substance analysis and the other test is
and you have released your batches with only 1 performed at the drug product stage.
type of assay results. Justify why your “as we are dealing with the toll manufacturing in order for
specifications, analytical method and practices better understanding on COA we opted the 90-115% assay
of batch release are not aligned with USP specifications. However, we have revised the SOP along
monograph recommendations. with the specifications and would update and align all the
15. Justify why the test for water contents, We were not performing these tests in our stability testing.
constituted solution etc is not performed during Whereas these tests were part of our routine testing.
stability studies since these tests are very The firm has performed water content determination test and
critical and are required to make assessment of submitted that relevant data.
the stability profile and shelf life.
batches along with HPLC chromatograms and accelerated and real time) of three batches along with the
raw data sheets in a proper sequence and with relevant chromatograms, raw data sheets etc as per the
separators as per the guidelines of registration guidelines of Registration Board.
Board for further evaluation.
17. Stability study data of initial time point is not The firm has submitted the required data alongwith raw data
submitted for any batch along with stability sheets and chromatograms.
studies.

1. HPLC 75.52%
Decision: Approved.
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name GENXONE Dry Powder Injection 2g (IV)
glass vials
drug product.
substance.
against the comparator i.e. Oxidil 2g Injection.
Manufacturer of API Zhuhai United Laboratories Co. Ltd. No. 2428, Anji Road, Sanzao Town,
Jinwan District Zhuhai Guangdong P.R China.
API Lot No. 3052004003
Description of Pack
Glass vials
No. of Batches 03
Evaluation by PEC:

1. Provide valid GMP certificate / inspection report The firm has submitted last inspection report dated
of the contract manufacturer since the submitted 01/04/2019. The firm has maintained conformance to
GMP certificate has been expired. GMP compliance in manufacturing and QC operations.
per the guidance document approved by procedures used for routine testing of drug substance by
Registration Board which specifies that “Copies both drug product and drug substance manufacturer in the
of the Drug substance specifications and relevant sections as per guidance document for Form 5F.
parameters in verification / validation studies of with the detail of concentrations of different dilutions used
the drug substance. Further justify significant to test the parameters of required studies.
difference in peak areas value at same
concentration during different tests like
5. Justify why the test of specificity is not The firm has submitted analytical method verification
performed during the verification / validation report mentioning the results of the test for specificity
studies of the drug substance. parameter for analytical method verification studies for
6. Submit COA of reference standard actually used Certificate of analysis of reference standard actually used
in the analysis of drug substance in section in the development of the applied product is provided.
3.2.S.5.
7. You have mentioned that 10ml water for The recommended volume for diluent (Water for Injection)
injection is used as diluent for the applied for 2g injection is 20mL as mentioned in product
product while the innovator’s product has monograph of Rocephin (IV)2g.
recommended use of much high volume of Compatibility studies of diluent that is water for injection
diluent. Justification is required in this regard. 20mL with the finished product has been performed and
submitted.
8. Justify why pharmaceutical equivalence studies The firm has stated that Pharmaceutical equivalence is
are conducted against comparator product performed against Oxidil 2g injection mfg by M/s Sami
instead of using innovator or reference product. Pharma. The innovator’s product is not avalaible in
9. Provide details of the diluent which is used to Water for injection 20mL is used as diluent for
perform compatibility studies of the drug reconstitution of drug product. The reconstituted product
product. is yellowish clear solution. The firm has submitted
compatibility studies of diluent with the rug product.
10. Provide details of sample solution 2 preparation Detail of preparation of sample solution II is provided in
i.e. exact volume of water required for initial the relevant section which is in-lined with USP for the
constitution of the ceftriaxone for injection. applied product.
as two different analysis, calculation formula monograph. Revised specifications are submitted which
and acceptance criteria as per USP monograph, are in-lined with USP.
while your specifications does not specify two The firm has stated that they have performed one test at the
different tests and acceptance criteria for assay stage of drug substance analysis and the other test is
and you have released your batches with only 1 performed at the drug product stage.
type of assay results. Justify why your “as we are dealing with the toll manufacturing in order for
specifications, analytical method and practices better understanding on COA we opted the 90-115% assay
of batch release are not aligned with USP specifications. However, we have revised the SOP along
monograph recommendations. with the specifications and would update and align all the
batches along with HPLC chromatograms and accelerated and real time) of three batches along with the
raw data sheets in a proper sequence and with relevant chromatograms, raw data sheets etc as per the
separators as per the guidelines of registration guidelines of Registration Board.
Board for further evaluation.
13. Submit stability study data of 3 commercial The firm has submitted stability study data of 3 batches as
batches manufactured by the drug product well.
manufacturer as per the decision of 312 th Batch size: 1000 vials
meeting of Registration Board wherein the Mfg date: 11/2020
Board decided that the permission for contract Date of initiation of stability studies: 05/12/2020
manufacturing shall be granted on the basis of Batches: T01, T02, T03
stability study data of commercial batches. Batch size: 1000 vials
14. Submit stability study data in section 3.2.P.8.3 The firm has submitted stability study data in section
as per the checklist approved by Registration 3.2.P.8.3 as per the checklist approved by Registration
Board in its 296th meeting and the CTD Board.
guidance document, which includes the  Lenzeu 30mg and 60mg Capsule (Dexlansoprazol)
following: approved in 297th meeting. & Tazipera 45g injection
o Reference of previous approval of approved in 316th meeting.
applications with stability study data of the  Copy of GMP certificate No. GD20180909 valid till
firm (if any) 05/12/2023, M/s Zhuhai United Laboratories Co., Ltd.,
o Approval of API/ DML/GMP certificate of issued by CFDA.
API manufacturer issued by concerned  Firm has submitted copy of commercial invoice cleared
regulatory authority of country of origin. dated 28-05-2020 specifying import of 100Kg
o Documents for the procurement of API with ceftriaxone sodium sterile (USP). The invoice is cleared
approval from DRAP (in case of import). by AD (I&E) DRAP.
o Data of stability batches will be supported by  Raw data sheet sand chromatograms have been
attested respective documents like submitted by the firm.
chromatograms, Raw data sheets, COA,  The firm has submitted record of digital data logger for
summary data sheets etc. accelerated and real time stability studies in the relevant
o Compliance Record of HPLC software section.
21CFR & audit trail reports on product  Compliance record of HPLC & audit trails are submitted.
testing.
o Record of Digital data logger for temperature
and humidity monitoring of stability
chambers (real time and accelerated)

1. HPLC 75.52%
Decision: Approved.
1077.Name, address of Applicant / Marketing M/s Z-Jans Pharmaceuticals Pvt. Ltd. 148-A
Authorization Holder Industrial area Hayatabad Peshawar
Name, address of Manufacturing site. M/s Z-Jans Pharmaceuticals Pvt. Ltd. 148-A
Industrial area Hayatabad Peshawar
☐ Importer
02-08-2018. The GMP certificate specifies dry
powder injection (cephalosporin) section.
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of
additional section dated 29-01-2009 specifying dry
☐ Export sale
The proposed proprietary name / brand name ZOCLAN 250mg Injection IV
Pharmaceutical form of applied drug Sterile white to almost white powder filled in
impurities, specifications, analytical procedures
and its validation, batch analysis and justification
of specification, reference standard, container
substance and drug product.
against the comparator i.e. Oxidil 250mg Injection
IM.
API Lot No.
Description of Pack
Glass vials
Batch No. C-FML 41K C-FML 42K C-FML 43K
No. of Batches 03
data sheets etc.
Evaluation by PEC:
 Submit differential fee for the registration of applied product, since the notification for revision of fee
vide SRO No. F.7-11/2012-B&A/DRA was published on 7th May 2021 while this application was
received in R&I section of DRAP after 7th May 2021.
 Specify whether your application is for IV or IM use.
 Submi module 2 and module 3 as per the format and data requirements as specified in the CTD
 Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per the guidance document approved by Registration
 Submit verification studies of the analytical method of drug substance performed by drug product
manufacturer in section 3.2.S.4.3.
 Submit COA of relevant batch of drug substance from API manufacturer as well as drug product
manufacturer in section 3.2.S.4.4 which is actually used for manufacturing of three stability batches.
 Submit COA of reference standard / working standard actually used in the analysis of drug substance
and drug product.
 Submit details of the manufacturer of the comparator product Recephin Injection Batch No. B0063
against which pharmaceutical eqivalence studies were conducted.
 Justify how the average weight of filled vials of the comparator product as well as your product is
272mg and the assay is 105%.
 Submit compatibility studies in section 3.2.P.2.6.
 Submit process validation protocols as per the requirements of CTD guidance document.
 Justify the specifications of the drug product which are not as per USP monograph, since the test for
constituted solution, bacterial endotoxin test, particulate matter in injection, crystallinity, pH, water
determination, assay having acceptance criteria (NLT 776 μg/mg of ceftriaxone) and impurities.
 Justify your analytical method for assay test of drug product which is entirely different from that of
USP in terms of mobile phase composition, standard and sample preparation, and chromatographic
conditions including UV wavelength, flow rate, injection volume etc.
 Justify the assay test of drug product using UV method in your specifications since no such test exist
in USP monograph.
 Provide verification studies of the analytical method of drug roduct in section 3.2.P.5.4 in the light of
ICH guidelines.
 Justify the stability testing of the product in which assay is determined using UV method against the
 Provide Batch Manufacturing Record of three stability batches for which stability study data is
submitted.
 Submit stability study data in section 3.2.P.8.3 as per the checklist approved by Registration Board in
its 296th meeting and the CTD guidance document, which includes the following:
o Record of Digital data logger for temperature and humidity monitoring of stability chambers
(real time and accelerated)
within six months.
1078.Name, address of Applicant / Marketing M/s Z-Jans Pharmaceuticals Pvt. Ltd. 148-A
Authorization Holder Industrial area Hayatabad Peshawar
Name, address of Manufacturing site. M/s Z-Jans Pharmaceuticals Pvt. Ltd. 148-A
Industrial area Hayatabad Peshawar
☐ Importer
02-08-2018. The GMP certificate specifies dry
Evidence of approval of manufacturing facility Firm has submitted copy of letter of grant of
☐ Export sale
The proposed proprietary name / brand name ZOCLAN 500mg Injection IV
Injection IM.
Description of Pack
Glass vials
Batch No. C-FML 31K C-FML 32K C-FML 31K
No. of Batches 03
data sheets etc.
Evaluation by PEC:
 Specify whether your application is for IV or IM use.
 Submi module 2 and module 3 as per the format and data requirements as specified in the CTD
 Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per the guidance document approved by Registration
 Submit verification studies of the analytical method of drug substance performed by drug product
manufacturer in section 3.2.S.4.3.
 Submit COA of relevant batch of drug substance from API manufacturer as well as drug product
manufacturer in section 3.2.S.4.4 which is actually used for manufacturing of three stability batches.
 Submit COA of reference standard / working standard actually used in the analysis of drug substance
and drug product.
 Submit details of the manufacturer of the comparator product Recephin Injection Batch No. B0063
against which pharmaceutical eqivalence studies were conducted. Further justify how same batch
number of the comparator product is used for 250mg and 500mg strength.
 Justify how the average weight of filled vials of the comparator product as well as your product is
550mg and the assay is 105%.
 Submit compatibility studies in section 3.2.P.2.6.
 Submit process validation protocols as per the requirements of CTD guidance document.
 Justify the specifications of the drug product which are not as per USP monograph, since the test for
constituted solution, bacterial endotoxin test, particulate matter in injection, crystallinity, pH, water
determination, assay having acceptance criteria (NLT 776 μg/mg of ceftriaxone) and impurities.
 Justify your analytical method for assay test of drug product which is entirely different from that of
USP in terms of mobile phase composition, standard and sample preparation, and chromatographic
conditions including UV wavelength, flow rate, injection volume etc.
 Justify the assay test of drug product using UV method in your specifications since no such test exist
in USP monograph.
 Provide verification studies of the analytical method of drug roduct in section 3.2.P.5.4 in the light of
ICH guidelines.
 Justify the stability testing of the product in which assay is determined using UV method against the
 Provide Batch Manufacturing Record of three stability batches for which stability study data is
submitted.
 Submit stability study data in section 3.2.P.8.3 as per the checklist approved by Registration Board in
its 296th meeting and the CTD guidance document, which includes the following:
within six months.
1079.Name, address of Applicant / Marketing M/s Davis Pharmaceuticals Laboratories, Plot #
Authorization Holder 121 Industrial Triangle Kahuta Road
Islamabad.
☐ Importer
2022.
The GMP certificate specifies Lyophilized vial
(General) section.
2022.
(General) section.
Lyophilized vial (General) section.
☐ Export sale
The proposed proprietary name / brand name ZOLARD Injection 30mg
Pharmaceutical ingredient (API) per unit Lansoprazole……30mg
Pharmaceutical form of applied drug Almost white coloured lyophilized hygroscopic
powder contained in glass vial
The status in reference regulatory authorities Lansoprazole Injection (USFDA Approved)
For generic drugs (me-too status) Qpro injection by Bosch Pharma
Rajasthan India.
against the comparator i.e. Selanz 30mg Injection.
API Lot No.
Description of Pack
Glass vials
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
data sheets etc.
Evaluation by PEC:
The application for contract manufacturing from M/s Bio-Labs (Pvt) Ltd. Islamabad is not submitted as per
recommendations of Registration Board and as per the guidance document. Furthermore, it is also pertinent to
mention that the drug product testing has been carried out using specifications which are not in line with the
recommendations of the general monographs of the official pharmacopoeia and the analytical method of the
assay test is based on UV method contrary to the method of analysis of the drug substance manufacturer and
innovator’s product.
Therefore, you are advised to resubmit your application compiled in the light of the guidance document
within six months.
1080.Name, address of Applicant / Marketing M/s Gray’s Pharmaceuticals. Plot No. 2, Street
Authorization Holder No. N-3, RCCI Rawat Rawalpindi.
☐ Importer
2022.
(General) section.
2022.
(General) section.
☐ Export sale
The proposed proprietary name / brand name LADAZOLE Injection 30mg
Pharmaceutical ingredient (API) per unit Lansoprazole……30mg
Pharmaceutical form of applied drug Almost white coloured lyophilized hygroscopic
powder contained in glass vial
The status in reference regulatory authorities Lansoprazole Injection (USFDA Approved)
For generic drugs (me-too status) Qpro injection by Bosch Pharma
Rajasthan India.
against the comparator i.e. Selanz 30mg Injection.
API Lot No. ALAN 18001
Description of Pack
Glass vials
Batch No. L-213 L-233 L-252
No. of Batches 03
1. Reference of previous approval of applications N/A
manufacturer issued by concerned regulatory Not submitted
3. Documents for the procurement of API with Firm has submitted copy of clearance certificate and
approval from DRAP (in case of import). invoice cleared by AD (I&E) specifying import of
3Kg lansoprazole powder.
4. Data of stability batches will be supported by Submitted by the firm
data sheets etc.
6. Record of Digital data logger for temperature and Submitted by the firm
Evaluation by PEC:
recommendations of Registration Board and as per the guidance document. Furthermore, it is also pertinent
to mention that the drug product testing has been carried out using specifications which are not in line with
the recommendations of the general monographs of the official pharmacopoeia and the analytical method of
the assay test is based on UV method contrary to the method of analysis of the drug substance manufacturer
and innovator’s product.
Therefore, you are advised to resubmit your application compiled in the light of the guidance document
Firm has now submitted application as per guidance document. However, the following observations are still
not addressed.
 Verification studies of the analytical method of drug substance since the API used is non-lyophilized
powder.
 pH of reference product is 9 – 10.5 while the limit set by firm is 9 – 12 and results are above 11.0
 Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory
 Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
within six months.
1081.Name, address of Applicant / Mar keting M/s Islam Pharmaceuticals. 7 km, Pasrur Road,
Authorization Holder Sialkot
☐ Importer
2022.
2022.
powder injection (cephalosporin).
☐ Export sale
The proposed proprietary name / brand name FORLAM 250mg Injection
Pharmaceutical ingredient (API) per unit Ceftazidime……250mg
Reference to Finished product specifications Innovator’s
The status in reference regulatory authorities Ceftazidime Injection (MHRA Approved)
For generic drugs (me-too status) Nivador injection by Sami Pharma
Name and address of API manufacturer. Qilu Antibiotics Pharmaceutical Co. Ltd. 849
Dongjia Town, Licheng District Jinan City PR
China.
against Fortum 250mg Injection of GSK.
Manufacturer of API Qilu Antibiotics Pharmaceutical Co. Ltd. 849 Dongjia Town, Licheng
District Jinan City PR China.
API Lot No.
Description of Pack
Glass vials
Batch No. VP-1454 VP-1546 VP-1633
No. of Batches 03
manufacturer issued by concerned regulatory SD20170590) issued by CFDA China dated 31-07-
data sheets etc.
Evaluation by PEC:
guidance document for various modules, sections and sub sections majorly including complete module 1,
section 3.2.S.4.1, 3.2.S.4.2, 3.2.S.4.3, 3.2.S.4.4, 3.2.S.5, 3.2.P.2.2.1, 3.2.P.2.6, 3.2.P.3.5, 3.2.P.5.1, 3.2.P.5.2,
3.2.P.5.3, 3.2.P.5.4, 3.2.P.6 and 3.2.P.8. Furthermore, it is also pertinent to mention that the drug product
manufacturer has submitted COA of drug substance imported in 2021 and released on 13-03-2021 and
provided batch release certificates of 3 batches of drug product released on 19-05-2021, 15-01-2021 and 22-
12-2020 and submitted stability study data of 3 batches of drug product 19-03-2018, 18-06-2018 and 17-09-
2018 instead of submitting data of same batches as per the guidance document. Therefore, you are advised to
resubmit your application compiled in the light of the guidance document approved by Registration Board and
also justifying the following additional observations so that further evaluation of your application could be
carried out.
 You have submitted Innovator’s specification in module 1 while the product monograph is available
in USP, revise the specifications along with submission of requisite fee.
 You have submitted label claim that each vial contains ceftazidime as sodium 250mg while the
innovator product contains ceftazidime pentahydrate.
 The specifications of the drug substance manufacturer is different from USP in terms of limit of loss
on drying as well as chromatographic conditions (including column specifications, wavelength, flow
rate, mobile phase etc). Justify how this material can be used to develop commercial batches of a
product which is registered with USP specifications.
 M/s Biolabs have released a batch of drug substance (Batch No. 1045AJ81JD) on 13-03-2021 in which
loss on drying was 13.45% while USP specifies that the limit of LOD is NMT 12.5%. Justify how this
drug substance was released for commercial use to manufacture batches of the drug product registered
with USP specifications.
 You have specified in section 3.2.P.1 that filled weight per vial is 250mg which is contrary to that of
the innovator product.
 Your product development and pharmaceutical equivalence studies does not include complete testing
as recommended by innovator product or by USP.
 Compatibility studies of your product shows that pH after reconstitution is from 3 to 4 which is
different from that of USP recommendations.
 Your drug substance specifications are different from that of drug substance manufacturer as well as
USP without any scientific rationale.
 Your process validation report performed on commercial batches have specified that weight variation
of the filled vials is approximately 250mg. Justify how 250mg powder per vial containing sodium
carbonate as well as 13.5% water can have 250mg of ceftazidime base as well.
 Your drug product specifications are not as per USP since many tests recommended by USP are not
performed by the product manufacturer even for the release of commercial batches in the market.
 The drug product manufacturer have not provided complete method of analysis of the drug product
although it is manufacturing commercial batches of the said product.
 Justify why contents of sodium carbonate is not performed in the drug product also provide evidence
of atomic absorption to justify that you have necessary equipment to carry out the product testing.
 The limit of Bacterial endotoxin test of the drug product manufacturer is different from USP
pharmacopoeia.
 Provide evidence of import of Ceftazidime, Delta-3-Isomer RS which is used in the analysis of drug
product.
 The drug product method of analysis specifies that a resolution solution containing Delta-3-Isomer
RS is added in the sample solution, while no peak is observed in the chromatograms. Justify how your
method of analysis can be considered accurate and reliable.
 Your analytical method verification studies are not performed in the light of ICH guidelines,
furthermore the analysis of results is also not performed as per ICH recommendations. Justify how
you have been testing commercial batches of the drug product without having a verified method of
analysis in which the resolution solution peak is also not observed in the chromatograms.
The firm has submitted stability study data of 3 newly manufactured batches of drug product without
addressing the observations mentioned in the letter of shortcoming.
Batch No. VP-339 VP-340 VP-361

Batch Size 15384 Packs 15384 vials 5,000 vials
 The analysis performed in the newly submitted data is still not as per USP monograph in terms of
relative retention time between ceftazidime and Delta-3-Isomer and the calculation of results of assay.
within six months.
1082.Name, address of Applicant / Marketing M/s Islam Pharmaceuticals. 7 km, Pasrur Road,
☐ Importer
2022.
2022.
☐ Export sale
The proposed proprietary name / brand name FORLAM 500mg Injection
Pharmaceutical ingredient (API) per unit Ceftazidime……500mg
China.
against Fortum 500mg Injection of GSK.
API Lot No. 0046L81F
Description of Pack
Glass vials
Batch No. VP-1453 VP-1545 VP-1632
No. of Batches 03
data sheets etc.
Evaluation by PEC:
05-2021 and submitted stability study data of 3 batches of drug product released on 19-03-2018, 18-06-2018
and 17-09-2018 instead of submitting data of same batches as per the guidance document. Therefore, you are
advised to resubmit your application compiled in the light of the guidance document approved by Registration
Board and also justifying the following additional observations so that further evaluation of your application
could be carried out.
 Submit differential fee for the registration of applied product as per SRO No. F.7-11/2012-B&A/DRA.
 Justify the assay result of ceftazidime pentahydrate 69.33% as per your test report dated 13-03-2021.
 You have specified in section 3.2.P.1 that filled weight per vial is 500mg which is contrary to that of
the innovator product.
of the filled vials is approximately 500mg (509-512mg). Justify how 500mg powder per vial
containing sodium carbonate as well as 13.5% water can have 500mg of ceftazidime base as well.
pharmacopoeia.
product.

Batch Size 7692 Packs 7692 vials 7692 vials
within six months.
1083.Name, address of Applicant / Marketing M/s Islam Pharmaceuticals. 7 km, Pasrur Road,
☐ Importer
2022.
2022.
☐ Export sale
The proposed proprietary name / brand name FORLAM 1g Injection
Pharmaceutical ingredient (API) per unit Ceftazidime……1g
China.
against Fortum 1g Injection of GSK.
API Lot No. 0046L81F
Description of Pack
Glass vials
Batch Size 7500 vials 3942 vials 7,000 vials
No. of Batches 03
data sheets etc.
Evaluation by PEC:
06-2020 and submitted stability study data of 3 batches of drug product released on 16-09-2019, 16-03-2020
and 19-03-2018 instead of submitting data of same batches as per the guidance document. Therefore, you are
advised to resubmit your application compiled in the light of the guidance document approved by Registration
Board and also justifying the following additional observations so that further evaluation of your application
could be carried out.
 Submit differential fee for the registration of applied product as per SRO No. F.7-11/2012-B&A/DRA.
 Justify the assay result of ceftazidime pentahydrate 69.33% as per your test report dated 13-03-2021.
 You have specified in section 3.2.P.1 that filled weight per vial is 1g which is contrary to that of the
innovator product.
of the filled vials is approximately 1000mg (1005-1011mg). Justify how 1000mg powder per vial
containing sodium carbonate as well as 13.5% water can have 1000mg of ceftazidime base as well.
pharmacopoeia.
product.

within six months.
1084.Name, address of Applicant / Marketing M/s Reliance Pharma, Plot # 8, Street No. S-8,
Authorization Holder RCCI, Industrial Estate, Rawat Islamabad.
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd. Plot No.
Islamabad.
☐ Importer
GMP status of the firm Global pharmaceuticals: 11 & 24-10-2018: On
the basis of findings, panel unanimously decided to
recommend the issuance of GMP certificate.
000417 of M/s Global Pharmaceuticals Islamabad
dated 03-02-2016 specifying reallocation of dry
powder injection (carbapenem) section is place of
withdrawn Biotech section (BSF)
☐ Export sale
The proposed proprietary name / brand name TAVIZEM 200mg/5ml suspension
bottle
Industrial Zone Port Qasim Karachi.
30°C ± 2°C / 65 ± 5% RH for 24 months.
against Cefiget 200mg/5ml dry suspension.
Manufacturer of API Saakh Pharma (Pvt) Ltd. C-7/1, North Western Industrial Zone Port Qasim
Karachi.
API Lot No. 18CF10062
18CF10068
18CF101233
Description of Pack
Glass bottle
Batch No. 18D145 18L054 18G104
Batch Size 5000 bottle 5000 bottle 5000 bottle
No. of Batches 03
Firm has submitted copy of GMP certificate issued
data sheets etc.
audit trail reports on product testing testing of HPLC for all test intervals.
Evaluation by PEC:
1. Submit GMP certificate / GMP inspection report Firm has submitted GMP certificate issued on the
of the drug product manufacturer within last three basis of inspection dated 03-01-2022.
years.
2. Submit evidence of approval of requisite The submitted GMP certificate specifies dry powder
manufacturing facility / section of the drug suspension (Cephalosporin) section.
product manufacturer approved from Licensing
Division DRAP.
3. Submit module 1 as per CTD guidance document Firm has submitted module 1 as per guidance
without referring to annexures. document.
4. Submit label claim as per the innovator product Firm has submitted label claim.
along with submission of fee for revision of label
claim.
5. Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as Specifications of drug substance from API
per the guidance document approved by manufacturer and product manufacturer is submitted
Registration Board which specifies that “Copies of by the firm.
the Drug substance specifications and analytical
procedures used for routine testing of the Drug
6. Justify how the drug substance specification As few tests were common in USP and BP therefore
complies both USP as well as BP specifications. drug substance manufacturer mentioned both in CoA
but we are following USP specification. Procedures as
per USP are attached
7. Submit data of verification of analytical procedure Firm has submitted verification of analytical
of drug substance in section 3.2.S.4.3 as per the procedure of drug substance.
guidance document approved by Registration
Board which specifies that “Analytical Method
Verification studies including specificity,
accuracy and repeatability (method precision)
performed by the Drug Product manufacturer for
both compendial as well as non-compendial drug
substance(s) shall be submitted”.
8. Submit COA of reference standard actually used Firm has submitted COA of reference working
in the analysis of drug substance and drug product. standard
9. Submit stability study data of the drug substance Firm has submitted stability data of API
(cefixime trihydrate in micronized form) from the
drug substance manufacturer as per zone IV-A
conditions.
10. Justify why your formulation is qualitatively As per function of excipients, we are following the
different from that of innovator’s product. innovator formulation. No other ingredient is changed
except the Thickening agent Xanthan Gum is replaced
with Carboxy methylcellulose Sodium. Carboxy
methylcellulose Sodium is synthetically prepared
thickening agent purer as compare to Xanthan gum
and has computability with cefixime.
11. Justify how 1383.1mg of cefixime trihydrate is Yes the 1383mg of cefixime Trihydrate is equivalent
equivalent to 6 doses after reconstitution each to 06 doses of 200mg cefixime.
having 200mg of cefixime base. Molecular weight of cefixime Trihydrate=507.50
Molecular weight of cefixime =453.46
%age purity of cefixime=
(453.46/507.5)*100=89.35% (when 100% cefixime is
present in cefixime Trihydrate), but USP states that: -
Cefixime contains the equivalent of not less than
950ug (95%) and not more 1030ug (103%) of
cefixime per mg, calculated on anhydrous basis.
So average content of cefixime will be
=(95+103)/2=99%
Considering the average purity of cefixime in cefixime
Trihydrate, then
89.35*(99/100)= 88.46%
For 06 doses of 200mg/5mlcefixime suspension:-
Cefixime required will be = 1200mg/Vial
1200mg cefiximewill be equivalent to
=(100/88.46)*1200=1355.438mg/Vial
2% overage was in practice due to production losses.
So the adopted fill weight= 1382.54
Note :- this 2% overage is removed from the
formulation now.
12. Justify how your product is equivalent to the All product registered in Pakistan for cefixime DS
innovator’s product since the innovator’s product Suspension (e.g. Cefspan DS Suspension brand leader
is available in 50ml, 75ml and 100ml bottle in Pakistan provide 30ml Pack size for 06 doses) is
delivering 10, 15 and 20 doses while your product also available in 30ml Pack size, those also delivers 6
is available in 30ml bottle which can deliver 6 doses.
doses.
13. Justify how you are reconstituting your product Reconstitution volume doesn’t have any effect on the
with 20ml water since the innovator product use quality of Dry suspension, but for the sake
34ml water to reconstitute for 50ml bottle. comparison, we suppose:- If innovator uses 34ml for
50ml reconstitution, then for 30ml reconstitution we
required =20.4ml, which is approximately equal to
20ml. As data of innovator formulation in quantitative
form is not available, so this kind of change does come
in generic development. Secondly as reference
“Cefspan DS Suspension” the brand leader in
Pakistan, is also reconstituting its product with 20ml
water.
14. Justify why you have performed pharmaceutical We have performed the pharmaceutical equivalence
equivalence studies against Cefiget suspension against the competitor product, which is allowed by
instead of performing studies against the innovator DRAP.
/ reference product.
15. Justify your pharmaceutical equivalence studies in Complete testing as per USP and innovator has been
which only assay and identification test has been performed
performed. Justify how you can declare your
product as pharmaceutically equivalent just on the
basis of two tests.
16. Justify why comparative dissolution profile / drug Dissolution test in the innovator recommended media
release studies are not performed for your product is attached 8 for you concern.
since USFDA has recommended such studies for Note:-We have provided you the commercial batches
cefixime suspension. data as per USP monograph, which doesn’t mention
the dissolution as quality parameter. Secondly the
SMPC of innovator product only give the dissolution
in one media (buffer pH 7.4), and mention it worthless
quality control tool. SMPC clearly states that
The current USP monograph for cefixime for oral
suspension doesn’t include dissolution. Itshould be
noted that under established test conditions, all
cefixime suspensions are rapidly dissolved (greater
than settled limit (75%) in first 10minutes; dissolution
is complete within 30minutes). The established test
therefore appears to have limited value as quality
control tool.
17. Provide detailed method of analysis of the drug Firm has submitted complete method of analysis of
product in section 3.2.P.5.2 instead of providing drug product.
USP monograph only.
18. Provide detailed analytical method verification Firm has submitted detailed analytical method
studies along with interpretation of each test in the verification studies of drug product.
light of ICH guidelines. Further also provide exact
concentration of each solution tested in each test
of the verification studies.
19. Provide COA of 3 batches of drug product in Frm has submitted COA of three batches of drug
section 3.2.P.5.4 for which stability study data is product.
submitted in section 3.2.P.8.3.
20. Provide COA of reference standard which is Firm has submitted COA of working standard.
actually used in the analysis of drug product.
21. Scientific justification for using only 3 6 injections of standard solution run for system
chromatograms of the standard solution for HPLC suitability confirmation in each assay and then 3 more
testing while USP General chapter <621>
recommends that five replicates of standard standards run in order to calculate results. System
solution should be used for system suitability suitability RSD Sheets are attached as annexure 12.
studies.
22. Provide reference of previous approval of Not submitted
applications with stability study data of the firm (if
any), instead of mentioning not applicable.
23. Provide documents for the procurement of API Firm has submitted invoice of different batches of API
including commercial invoice of the relevant
batch of drug substance used in the manufacturing
of 3 batches for which stability study data is
submitted.
24. Provide stability study data of 3 batches of the Submitted by the firm
drug product in section 3.2.P.8.3 as per the 6
points checklist approved by Registration Board in
CTD guidance document along with submission
of stability study data of each batch in proper
sequence i.e. analytical report, raw data sheet and
chromatograms of standard and sample
preparation at each time point so that further
evaluation of the data could be carried out.
Decision: Approved.
 Manufacturer shall submit data of product testing of recently manufactured commercial
batches as per USP before issuance of Registration Letter.
1085.Name, address of Applicant / Marketing M/s Hygeia Pharmaceuticals, Plot No. 295,
Authorization Holder Industrial Triangle Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Rotex Pharma (Pvt) Ltd, Plot # 206 & 207,
☐ Importer
GMP status of the firm Rotex pharma: GMP certificate issued on the basis
of inspection dated 12-08-2020
000651 of M/s Rotex Pharma Islamabad dated 13-
06-2017 specifying dry powder injection
☐ Export sale
The proposed proprietary name / brand name MEROMAX 1g Injection
Pharmaceutical ingredient (API) per unit Meropenem trihydrate eq to meropenem……1g
Pharmaceutical form of applied drug White to off white powder filled in clear glass vials
with dark blue flip off seal
Name and address of API manufacturer. M/s Sterile India Pvt Ltd. Plot No. 100& 118-G,
Phase-IV, Sector-56, HSIIDC, Industrial Estate
Kundli District Sonepat Haryana India.
Module-II (Quality Overall Summary)
30°C ± 2°C / 65 ± 5% RH for 36 months.
against Meronem 1g Injection of Pfizer Pakistan
Ltd manufactured by ACS Dobfar Italy.
Manufacturer of API M/s Sterile India Pvt Ltd. Plot No. 100& 118-G, Phase-IV, Sector-56,
HSIIDC, Industrial Estate Kundli District Sonepat Haryana India.
API Lot No.
Description of Pack
Glass vial
Batch No. C161001 C161002 C161003
No. of Batches 03
1. Reference of previous approval of applications 
data sheets etc.
Evaluation by PEC:
The product development and stability study data of the contract manufacturer was considered by Registration
Board in its 312nd meeting and observed that the contract manufacturer has not performed complete product
development studies, and the specifications adopted by the manufacturer throughout stability studies were not
according to USP and further observed that the stability batches have expired. Accordingly, the Board deferred
for following submissions:
 Scientific justification for not performing compatibility studies with the recommended diluent.
 Scientific justification for using an entirely different formula for calculation of assay results of
 Scientific justification for not performing test of sodium content.
 Scientific justification for not performing critical tests like constituted solution, and loss on drying
during the stability studies.
 Scientific justification for performing stability studies in which the test of bacterial endotoxin and
sterility is not performed at 6 months time interval.
 Scientific justification for using only 3 chromatograms of the standard solution for HPLC testing while
USP General chapter <621> recommends that five replicates of standard solution should be used for
system suitability studies.
 Evidence of purchase of atomic absorption spectrophotometer including commercial invoice and
Installation Qualification (IQ) and Operational Qualification (OQ) of atomic absorption alongwith
performance data for sodium content test on stability batches.
 Submission of fee for pre-registration changes in the drug product specifications.
The Board further decided that the submitted stability study data is not acceptable and directed the contract
manufacturer to either perform complete product development and stability studies as per USP specifications
or submit aforementioned data for commercial batches manufactured as per USP specifications.
within six months.
1086.Name, address of Applicant / Marketing M/s Jupiter Pharma, Plot # 25, S-6, National
Authorization Holder Industrial Zone Rawat Islamabad.
☐ Importer
Bio-Labs dated 21-05-2019 based on the
inspection dated 23-04-2019. The certificate is
(General) section.
The GMP certificate specifies Liquid ampoule
(General) section.
☐ Export sale
The proposed proprietary name / brand name JUTIG Injection 50mg
Pharmaceutical ingredient (API) per unit Tigecycline………50mg
Pharmaceutical form of applied drug Almost yellow colored lyophilized powder
Pharmacotherapeutic Group of (API) Antibacterial agent
The status in reference regulatory authorities Tygacil Injection (USFDA Approved)
For generic drugs (me-too status) Tygacil Injection by Pfizer
Name and address of API manufacturer. Fuan Pharmaceutical Group Chongqing Bosen
Pharmaceutical Co. Ltd. No. 1 Huanan Yi Road,
Changshou District Chongqing China.
product.
Pharmaceutical Equivalence and Comparative Firm has performed pharmaceutical equivalence
Dissolution Profile against the product BTig 50 mg injection by Bosch
Pharma
product substance and validation studies of the drug
product.
Manufacturer of API Fuan Pharmaceutical Group Chongqing Bosen Pharmaceutical Co. Ltd. No.
1 Huanan Yi Road, Changshou District Chongqing China.
API Lot No.
Description of Pack
Glass Vial
Batch No. L-131 L-138 L-242
Batch Size 1,000 Packs 1,000 Packs 700 Packs
No. of Batches 03
manufacturer issued by concerned regulatory CQ20180031) issued by CFDA China. The
data sheets etc.
Evaluation by PEC:
 Submit valid contract manufacturing agreement.
 Provide label claim as per the innovator’s product in module 1.
 Submit data in section 3.2.S.4.1 and 3.2.S.4.2 as per the guidance document approved by
Registration Board which specifies that “Copies of the Drug substance specifications and analytical
procedures used for routine testing of the Drug substance /Active Pharmaceutical Ingredient by both
Drug substance & Drug Product manufacturer is required.”
 Justify how the drug substance specifications conforms to USP, since the acceptance criteria for
various tests is different from USP monograph.
 Submit data of verification of analytical procedure of drug substance in section 3.2.S.4.3 as per the
guidance document approved by Registration Board which specifies that “Analytical Method
Verification studies including specificity, accuracy and repeatability (method precision) performed
by the Drug Product manufacturer for both compendial as well as non-compendial drug substance(s)
shall be submitted”.
 Provide COA of relevant batch of drug substance used in the manufacturing of batches for which
 Justify the stability studies of the drug substance as per zone IV-A conditions, since as per API
manufacturer as well as USP the storage conditions is to store the drug substance from 2 to 8 degree.
 Justify the pharmaceutical equivalence studies against the comparator product instead of performing
these studies against the innovator / reference product.
 Justify why complete tests as mentioned in USP are not performed during pharmaceutical
equivalence studies.
 Provide detailed method of manufacturing including details of the amount of distilled water added
to prepare the solution and the pH range which is maintained for that solution and exact temperature
and total time used for lyophilization process.
 Justify your process validation protocols and reports which does not include any step for
optimization of the solution preparation and lyophilization process.
 Provide details of the lyophilizer installed in your premises including details of the minimum and
maximum capacity of the equipment.
 Provide evidence of autosampler and low actinic glassware to carry out the analysis of the drug
product.
 Provide results of verification studies of the analytical method of drug product in the light of ICH
guidelines.
 Batch L-131 and L-138 are manufactured using drug substance from any other source while the
batch L-242 was manufactured using drug substance from the source which is mentioned in module
3. Justification is required in this regard.
 Justify how three injections of standard solution were used for the assay testing of the drug product
in stability studies.
 Provide Reference of previous approval of applications with stability study data of the firm (if any)
instead of mentioning not applicable.
 Provide Documents for the procurement of API with approval from DRAP (in case of import) for
the relevant batch of drug substances which are used in the manufacturing of 3 batches of drug
product whose stability data is submitted in section 3.2.P.8.3.
 Provide batch manufacturing record of three stability batches.
within six months.
Islamabad.
☐ Importer
(General) section.
(General) section.
☐ Export sale
The proposed proprietary name / brand name DAVICOBAL Injection 500mcg
Strength / concentration of drug of Active Each 1 ml ampoule Contains:
Pharmaceutical ingredient (API) per unit Mecobalamin………500mcg
Pharmaceutical form of applied drug Almost red colour solution filled in amber glass
ampoule.
Pharmacotherapeutic Group of (API) Vitamin B12
Proposed Pack size 1ml x 10’s
The status in reference regulatory authorities Mecobalamin 500mcg Injection (PMDA Japan
Approved)
For generic drugs (me-too status) Mecomax Injection by Global Pharma
Name and address of API manufacturer. M/s. Vital Laboratories (Pvt) Ltd.
Plant II, Plot No. 1710, GIDC Estate, Phase III,
Vapi – 396 195 Gujrat India
product.
Pharmaceutical Equivalence and Comparative Firm has performed pharmaceutical equivalence
Dissolution Profile against the product Methycobal 500 mg injection
by Hilton Pharma
product.
Manufacturer of API M/s. Vital Laboratories (Pvt) Ltd. Plant II, Plot No. 1710, GIDC Estate,
Phase III, Vapi – 396 195 Gujrat India
API Lot No. MCB2010061
Description of Pack Glass ampoule
Batch No. A-431 A-443 A-456
Batch Size 37,000 Ampoules 10,000 Ampoules 10,800 ampoules
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API GMP certificate # 20031928 of M/s. Vital
manufacturer issued by concerned regulatory Laboratories (Pvt) Ltd. Plant II, Plot No. 1710,
authority of country of origin. GIDC Estate, Phase III, Vapi – 396 195 Gujrat
India
valid upto 16-03-2023
3. Documents for the procurement of API with Firm has submitted attested copy of invoice
approval from DRAP (in case of import). (invoice # HHM/2021/00256) attested by AD
DRAP
data sheets etc.
Evaluation by PEC:
 Provide label claim as per the innovator’s product in module 1.
 Provide COA of relevant batch of drug substance used in the manufacturing of batches for which
stability study data is submitted, since the submitted COA is of batch manufactured in 2020, while
stability batches were manufactured in 2018.
 Justify your master formulation in which sodium chloride, propylene glycol, benzyl alcohol, sodium
acetate and water for injection is used as excipient, since the innovator product only use D-mannitol
and pH regulator.
 Justify the use of preservative in a single dose ampoule preparation.
 Justify the use of around 45% overage of active ingredient in your master formulation while USP
recommends much lower overage for vitamin B12.
 Justify why complete tests as mentioned in general monographs for such preparations are not
performed during pharmaceutical; equivalence studies.
 Justify how pharmaceutical equivalence studies were conducted with results of assay 127.80% and
128.30% for test and comparator product in the light of USP general chapters and allowable limit of
overages for vitamin B12.
 Justify why the test for particulate matter, uniformity of dosage unit and antimicrobial preservative
content / effectiveness is not included in the drug product specifications, since these tests are
recommended in general monograph of USP.
 Justify the pH value of 5 – 7, since the pH of the innovator’s product is 5.3 – 7.3. Revise your
specifications along with submission of requisite fee.
 Justify the analytical method for assay and identification test based on UV method, since the drug
substance manufacturer’s method as well as the innovator product analytical method is based on
HPLC testing.
 Justify the validation studies based on UV method, since the innovator’s product methodis based on
HPLC testing.
 Justify how the three batches i.e. I-150, I-163 and I-173 were released in 2019 having assay values
of 100, 100.1and 100.2% respectively while 145% overage of the active ingredient was added.
 Provide COA of reference standard actually used in the analysis of drug product.
 Provide batch number in terms of number of ampoules for batch A-431.
 Provide exact lot number of COA of drug substance used in manufacturing of each batch of drug
product.
 Justify the results of assay as all the batches just showed minor decrease in assay results less than
which is usually observed in vitamin preparations. Scientific justification / clarification is required
in this regard.
 Justify why photostability studies are not performed for the drug product.
 Provide Reference of previous approval of applications with stability study data of the firm (if any)
instead of mentioning not applicable.
 Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory
 Documents for the procurement of API with approval from DRAP (in case of import).
 Provide batch manufacturing record of three stability batches.
 Specify the details how the manufacturing and analysis of the product was carried out without
exposure to light. Further also provide evidence of light resistant vessels to carry out analysis as
recommended in JP monograph.
within six months.
Islamabad.
☐ Importer
(General) section.
(General) section.
☐ Export sale
The proposed proprietary name / brand name NALPHIN Injection 10mg/mL
Pharmaceutical ingredient (API) per unit Nalbuphine HCl………10mg
Pharmaceutical form of applied drug
Pharmacotherapeutic Group of (API) Morphinan derivatives
The status in reference regulatory authorities Nalbuphine Injection 10mg/ml (USFDA
Approved)
For generic drugs (me-too status) Nalbin Injection by Global Pharma
Name and address of API manufacturer. Mallinckrodt Pharmaceuticals SpecGx LLC 3600
North Second Street St. Louis, Missouri
product.
product against the comparator i.e. Kinz injection
of Sami Pharma
product.
Manufacturer of API Mallinckrodt Pharmaceuticals SpecGx LLC 3600 North Second Street St.
Louis, Missouri
API Lot No. 1909000314
Description of Pack
Glass ampoule
Batch No. A-429 A-552 A-608
Batch Size 15000 ampoules 50,000 ampoules 50,000 ampoules
No. of Batches 03
nalbuphine hydrochloride. The invoice is not
attested by AD (I&E) DRAP Field office. Firm has
also submitted copy of Form 3 and form 7.
summary data sheets.
data sheets etc.
Evaluation by PEC:
 Submit contract manufacturing agreement between contract giver and contract acceptor.
 Submit data of batch analysis of drug substance in section 3.2.S.4.4 as per the guidance document
approved by Registration Board which specifies that “Provide results of analysis of relevant
batch(es) of Drug Substance performed by Drug Product manufacturer used during product
development and stability studies, along with Certificate of Analysis (CoA) of the same batch from
Drug Substance / /Active Pharmaceutical Ingredient manufacture” since the submitted COA is for
the batch manufactured in December 2020 while the drug product batches were manufactured in
2018 and 2019.
 Provide COA of reference standard which is actually used in the analysis of drug substance in section
3.2.S.5.
 Justify your master formulation without any solvent / diluent, further justify how you are using
sodium chloride as solvent.
 Justify your master formulation which is significantly different from the innovator product in terms
of quantitative composition where you have used sodium citrate, sodium chloride and citric acid
anhydrous in 29.71%, 6.34% and 36.03% respectively, since the innovator product specifies sodium
citrate, sodium chloride and citric acid anhydrous in 0.94%, 0.2% and 1.26% respectively.
 Justify why pharmaceutical equivalence was performed against the comparator product instead of
 Justify why the pharmaceutical equivalence study does not include complete testing of the drug
product and the comparator product including the tests recommended by innovator product as well
as the tests recommended in general monographs of official pharmacopoeia.
 Justify how you are not performing terminal sterilization for your product.
 Specify the container closure system whether available in amber color glass ampoule or otherwise.
 Justify why the specifications of the drug product (section 3.2.P.5.1) does not contain complete tests
as recommended by innovator product as well as the tests recommended in general monographs of
official pharmacopoeia.
 Justify the pH of your product between 3 to 4.5 since the pH of the innovator product is 3.5 to 3.7.
Revise your specifications along with submission of requisite fee.
 Justify your analytical method for assay testing of the drug product which is based on UV analysis,
since the analytical method of drug substance manufacturer as well as innovator / reference product
is based on HPLC method.
 Justify your validation studies of the drug product in the light of ICH guidelines, since your analysis
and reporting of the results is not exactly in line with the ICH recommendations.
 Justify why the stability study data of three different batches is submitted from those for which batch
analysis is provided in section 3.2.P.5.4.
 You have submitted that the drug substance manufacturer is Mallinckrodt Pharmaceuticals SpecGx
LLC 3600 North Second Street St. Louis, Missouri, but the drug substance used in the manufacturing
of 3 batches of drug product is from any other source. Justification is required in this regard.
 Justify significant difference in the batch size of your products ranging from 15,000 to 50,000
ampoules. Justify your response in the light of the minimum and maximum capacity of your
manufacturing equipments.
 Justify the pH of batch A-608 where the pH value exceed 3.70 to 3.78 during stability studies, since
the maximum pH limit defined by innovator product is 3.70.
 Provide raw data sheets to justify the calculation of results for assay testing at each time point during
the stability testing of each batch. Submit complete data with proper separators and in a sequence
along with raw data sheets.
 Submit reference of previous approval of applications with stability study data of the firm instead of
mentioning not applicable.
 Submit valid GMP certificate of the drug substance manufacturer.
 Submit documents for the procurement of API with approval from DRAP for the relevant batch of
API which is used in the manufacturing of stability batches.
 Submit Batch Manufacturing Record of three batches for which stability study data is submitted.
 Submit copy of batch manufacturing record of 3 stability batches.
within six months.
1089.Name, address of Applicant / Marketing M/s Alliance Pharmaceuticals (Pvt) Ltd. 112-A
Authorization Holder Industrial Estate Hayatabad Peshawar.
☐ Importer
(General) section.
(General) section.
☐ Export sale
The proposed proprietary name / brand name ALLOPHINE Injection 10mg/mL
Pharmaceutical ingredient (API) per unit Nalbuphine HCl………10mg
Pharmacotherapeutic Group of (API) Morphinan derivatives
The status in reference regulatory authorities Nalbuphine Injection 10mg/ml (USFDA
Approved)
For generic drugs (me-too status) Nalbin Injection by Global Pharma
Name and address of API manufacturer. Mallinckrodt Pharmaceuticals SpecGx LLC 3600
North Second Street St. Louis, Missouri
product.
product against the comparator i.e. Kinz injection
of Sami Pharma
product.
Manufacturer of API Mallinckrodt Pharmaceuticals SpecGx LLC 3600 North Second Street St.
Louis, Missouri
API Lot No.
Description of Pack
Glass ampoule
Batch No. A-429 A-552 A-608
Batch Size 15000 ampoules 50,000 ampoules 50,000 ampoules
No. of Batches 03
nalbuphine hydrochloride. The invoice is not
attested by AD (I&E) DRAP Field office. Firm has
also submitted copy of Form 3 and form 7.
data sheets etc.
Evaluation by PEC:
 Submit data of batch analysis of drug substance in section 3.2.S.4.4 as per the guidance document
approved by Registration Board which specifies that “Provide results of analysis of relevant
batch(es) of Drug Substance performed by Drug Product manufacturer used during product
development and stability studies, along with Certificate of Analysis (CoA) of the same batch from
Drug Substance / /Active Pharmaceutical Ingredient manufacture” since the submitted COA is for
the batch manufactured in December 2020 while the drug product batches were manufactured in
2018 and 2019.
3.2.S.5.
 Justify your master formulation without any solvent / diluent, further justify how you are using
sodium chloride as solvent.
 Justify your master formulation which is significantly different from the innovator product in terms
of quantitative composition where you have used sodium citrate, sodium chloride and citric acid
anhydrous in 29.71%, 6.34% and 36.03% respectively, since the innovator product specifies sodium
citrate, sodium chloride and citric acid anhydrous in 0.94%, 0.2% and 1.26% respectively.
 Justify why pharmaceutical equivalence was performed against the comparator product instead of
product and the comparator product including the tests recommended by innovator product as well
as the tests recommended in general monographs of official pharmacopoeia.
 Justify how you are not performing terminal sterilization for your product.
 Specify the container closure system whether available in amber color glass ampoule or otherwise.
 Justify why the specifications of the drug product (section 3.2.P.5.1) does not contain complete tests
as recommended by innovator product as well as the tests recommended in general monographs of
official pharmacopoeia.
 Justify the pH of your product between 3 to 4.5 since the pH of the innovator product is 3.5 to 3.7.
Revise your specifications along with submission of requisite fee.
 Justify your analytical method for assay testing of the drug product which is based on UV analysis,
since the analytical method of drug substance manufacturer as well as innovator / reference product
is based on HPLC method.
 Justify your validation studies of the drug product in the light of ICH guidelines, since your analysis
and reporting of the results is not exactly in line with the ICH recommendations.
 Justify why the stability study data of three different batches is submitted from those for which batch
analysis is provided in section 3.2.P.5.4.
 You have submitted that the drug substance manufacturer is Mallinckrodt Pharmaceuticals SpecGx
LLC 3600 North Second Street St. Louis, Missouri, but the drug substance used in the manufacturing
of 3 batches of drug product is from any other source. Justification is required in this regard.
 Justify significant difference in the batch size of your products ranging from 15,000 to 50,000
ampoules. Justify your response in the light of the minimum and maximum capacity of your
manufacturing equipments.
 Justify the pH of batch A-608 where the pH value exceed 3.70 to 3.78 during stability studies, since
the maximum pH limit defined by innovator product is 3.70.
 Provide raw data sheets to justify the calculation of results for assay testing at each time point during
the stability testing of each batch. Submit complete data with proper separators and in a sequence
along with raw data sheets.
 Submit reference of previous approval of applications with stability study data of the firm instead of
mentioning not applicable.
 Submit valid GMP certificate of the drug substance manufacturer.
 Submit documents for the procurement of API with approval from DRAP for the relevant batch of
API which is used in the manufacturing of stability batches.
 Submit copy of batch manufacturing record of 3 stability batches.
within six months.
1090.Name, address of Applicant / Mar keting M/s Farm Aid Group Pharmaceuticals, 3/2
Haripur.
Name, address of Manufacturing site M/s Cure Laboratories (Pvt) Ltd. Plot # 11-12,
Islamabad.
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name SOCEF 1g Injection IV
product.
Description of Pack
Glass vials
Batch No. 20025 20026 20027
Date of Initiation
No. of Batches 03
data sheets etc.
Evaluation by PEC:
 Provide valid GMP certificate of the drug product manufacturer.
 Justify the drug substance specifications submitted in section 3.2.S.4.1 which states that the material
is non-sterile and the assay limit is 98 – 102% which is contrary to that specified in USP monograph
for ceftriaxone for injection. Furthermore, clarify whether you have used sterile ready to fill drug
substance or non-sterile ceftriaxone sodium.
 Justify how the drug substance batch No. Q012002060 was released on 18-05-2020 without
performing sterility test since this test is mentioned in the drug substance specifications as well as
COA of drug substance manufacturer. Justify how 200kg material was released for production
without performing sterility test.
3.2.S.5.
 Justify the label claim submitted in section 3.2.P.1 which specifies that each vial contains 1g
ceftriaxone sodium.
 Justify how 1200mg ceftriaxone sodium sterile powder per vial will be equivalent to 1g of
ceftriaxone base.
 Specify the type of diluent along with its exact volume which is to be used for the reconstitution of
the applied product.
product and the innovator product as per USP specifications. Justify how only pH and assay test can
demonstrate pharmaceutical equivalence.
 Provide details including the batch number, expiry date and manufacturer of the comparator product
against which pharmaceutical equivalence is conducted.
 Justify why compatibility study of the drug product along with recommended diluent is not
performed as per the requirement of section 3.2.P.2.6. Further justify how you have completed
product development without performing complete studies.
 Justify your process validation protocols without any process for optimization of sterilization process
and sealing of vials etc. Further justify why complete process validation is not performed since
commercial batches of the drug product have been manufactured by the manufacturer.
 Justify why the specifications of the drug product (section 3.2.P.5.1) does not contain important tests
as recommended by USP including test for constituted solution, particulate matter in injection,
crystallinity and complete assay test.
 Provide detailed testing method for the drug product as per the USP specifications since the
submitted method is not complete. Also submit fee for revision of specifications in the light of USP
monograph.
 Clarify the sample solution preparation method in your analysis which states “constitute ceftriaxone
for injection in a volume of water corresponding to the volume of solvent specified in the labelling”.
Specify what is the exact volume in which reconstitution is to be carried out instead of mentioning
generalized statements.
 Justify how three commercial batches were released for commercial use without performing
complete tests as specified in USP monograph.
 Provide COA of reference standard actually used in the analysis of drug product in section 3.2.P.6.
 Provide details of the primary and secondary packaging material of the drug product including details
of type, colour and specifications of the glass vial, rubber stopper and seal etc. in section 3.2.P.7.
 The batches are released after 16-06-2020, while the stability studies were initiated on 02-06-2020.
Justify how the batch could be initiated for stability studies before the batch release.
 Justify why the test for bacterial endotoxin, sterility, water contents, constituted solution etc is not
performed during stability studies since these tests are very critical and are required to make
assessment of the stability profile and shelf life.
 Justify the raw data sheets in which sample preparation method is incomplete.
 Justify how only single value of peak area of standard and sample is used to calculate the assay of
drug product during stability studies.
 Submit date of initiation of stability studies for all the three batches.
 Justify the testing at 3rd month time point on 25-08-2020 while the batches were released after 16-
06-2020. Provide complete justifications of the stability schedule with respect to testing time points
to justify that 6 months stability studies have been conducted and the time period between 0 to 3rd
month and 3rd to 6th month is justifiable in the light of ICH / WHO guidelines.
 Provide stability data sheets for all the batches as per the template provided in the CTD guidance
document since your template does not contain various information like stability initiation date, API
lot number, date of testing at 0 month, 3rd month and 6th month time point.
 Provide complete record of the stability testing of each batch with proper separators in a sequence
instead of separately providing the data without any sequence.
 Submit stability study data in section 3.2.P.8.3 as per the checklist approved by Registration Board
in its 296th meeting and the CTD guidance document, which includes the following:
o Approval of API/ DML/GMP certificate of API manufacturer issued by concerned
 Justify the manufacturing of batches having 4166 batch size in which 5Kg of drug substance was
used, keeping in view the fact that the drug substance also contains 9.1% water which is evident
from the COA of the relevant batch of drug substance.
 Justify the supply of 5ml WFI along with ceftriaxone sodium 1g IV injection since the innovator
product recommends different quantity of diluent.
within six months.
1091.Name, address of Applicant / Mar keting M/s Farm Aid Group Pharmaceuticals, 3/2
Haripur.
Islamabad.
☐ Importer
section.
☐ Export sale
The proposed proprietary name / brand name SOCEF 500mg Injection IM
product.
Injection.
Description of Pack
Glass vials
Batch No. 20031 20032 20033
No. of Batches 03
data sheets etc.
Evaluation by PEC:
 Provide valid GMP certificate of the drug product manufacturer.
 Justify the drug substance specifications submitted in section 3.2.S.4.1 which states that the material
is non-sterile and the assay limit is 98 – 102% which is contrary to that specified in USP monograph
for ceftriaxone for injection. Furthermore, clarify whether you have used sterile ready to fill drug
substance or non-sterile ceftriaxone sodium.
 Justify how the drug substance batch No. Q012002060 was released on 18-05-2020 without
performing sterility test since this test is mentioned in the drug substance specifications as well as
COA of drug substance manufacturer. Justify how 200kg material was released for production
without performing sterility test.
3.2.S.5.
 Justify the label claim submitted in section 3.2.P.1 which specifies that each vial contains 500mg
ceftriaxone sodium.
 Justify how 600mg ceftriaxone sodium sterile powder per vial will be equivalent to 500mg of
ceftriaxone base.
 Specify the type of diluent along with its exact volume which is to be used for the reconstitution of
the applied product.
product and the innovator product as per USP specifications. Justify how only pH and assay test can
demonstrate pharmaceutical equivalence.
 Provide details including the batch number, expiry date and manufacturer of the comparator product
against which pharmaceutical equivalence is conducted.
 Justify why compatibility study of the drug product along with recommended diluent is not
performed as per the requirement of section 3.2.P.2.6. Further justify how you have completed
product development without performing complete studies.
 Justify your process validation protocols without any process for optimization of sterilization process
and sealing of vials etc. Further justify why complete process validation is not performed since
commercial batches of the drug product have been manufactured by the manufacturer.
 Justify why the specifications of the drug product (section 3.2.P.5.1) does not contain important tests
as recommended by USP including test for constituted solution, particulate matter in injection,
crystallinity and complete assay test.
 Provide detailed testing method for the drug product as per the USP specifications since the
submitted method is not complete. Also submit fee for revision of specifications in the light of USP
monograph.
 Clarify the sample solution preparation method in your analysis which states “constitute ceftriaxone
for injection in a volume of water corresponding to the volume of solvent specified in the labelling”.
Specify what is the exact volume in which reconstitution is to be carried out instead of mentioning
generalized statements.
 Justify how three commercial batches were released for commercial use without performing
complete tests as specified in USP monograph.
 Provide COA of reference standard actually used in the analysis of drug product in section 3.2.P.6.
 Provide details of the primary and secondary packaging material of the drug product including details
of type, colour and specifications of the glass vial, rubber stopper and seal etc. in section 3.2.P.7.
 The batches are released after 16-06-2020, while the stability studies were initiated on 02-06-2020.
Justify how the batch could be initiated for stability studies before the batch release.
 Justify why the test for bacterial endotoxin, sterility, water contents, constituted solution etc is not
performed during stability studies since these tests are very critical and are required to make
assessment of the stability profile and shelf life.
 Justify the raw data sheets in which sample preparation method is incomplete.
 Justify how only single value of peak area of standard and sample is used to calculate the assay of
drug product during stability studies.
 Submit date of initiation of stability studies for all the three batches.
 Justify the testing at 3rd month time point on 25-08-2020 while the batches were released after 16-
06-2020. Provide complete justifications of the stability schedule with respect to testing time points
to justify that 6 months stability studies have been conducted and the time period between 0 to 3 rd
month and 3rd to 6th month is justifiable in the light of ICH / WHO guidelines.
 Provide stability data sheets for all the batches as per the template provided in the CTD guidance
document since your template does not contain various information like stability initiation date, API
lot number, date of testing at 0 month, 3rd month and 6th month time point.
 The results of accelerated stability study data of batch 20033 shows significant change (i.e. the assay
value increase from 97.54% at initial time point to 104.93% at 6th month time point), justify how the
evaluation for the significant change is not made in light of ICH guidelines.
 Provide complete record of the stability testing of each batch with proper separators in a sequence
instead of separately providing the data without any sequence.
o Approval of API/ DML/GMP certificate of API manufacturer issued by concerned
within six months.
1092.Name, address of Applicant / Marketing M/s Variant Pharmaceuticals Pvt Ltd.
Authorization Holder Plot No. 5, M2-Pharma Zone Lahore,
Sharikpur Road, Sheikhupura
☐ Importer
The GMP certificate specifies oral dry powder
☐ Export sale
The proposed proprietary name / brand name VARICEF 400mg Capsule
Pharmaceutical form of applied drug Orange / ivory colored hard gelatin capsule shells
size 0 filled with almost off white to light yellow
colored granular powder
Reference to Finished product specifications Innovator specification
product.
30°C ± 2°C / 65 ± 5% RH for 24 months.
product against Cefspan capsule.
Manufacturer of API Saakh Pharma (Pvt) Ltd. C-7/1, North Western Industrial Zone, Port Qasim,
Karchi.
17CF101233
17CF101235
Description of Pack
Alu-alu blister
Batch No. 271 267 261
Batch Size 60,000 capsule 25,000 capsule 25,000 capsule
No. of Batches 03
manufacturer issued by concerned regulatory by Additional Director DRAP, Karachi dated 23-
authority of country of origin. 06-2020. The GMP certificate was granted based on
data sheets etc.
Evaluation by PEC:
 Submit module 1 as per the CTD guidance document approved by Registration Board by providing
all the information and documents in relevant sections / sub-sections instead of referring to
annexures.
 Submit label claim in module 1 as per the reference product along with submission of requisite fee.
 You have mentioned innovator’s specification in section 1.5.6 in module 1 and in-house
specifications in module 2 section 2.3.P.5.1 while the drug product monograph is available in JP.
Revise the specifications along with submission of requisite fee.
 The drug substance manufacturer has claimed both BP and USP specifications for the drug
substance, provide scientific justification in this regard.
 The drug substance manufacturer has claimed USP specifications for the assay method, while the
submitted method is different from USP in terms of column specifications including column length
and pore size. Justification is required in this regard.
 Submit data in section 3.2.S.4.3 as per the decision of 293rd 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”. Further justify how the analysis of drug substance
was conducted without performing verification studies of the analytical method of drug substance.
specifies that “Provide results of analysis of relevant batch(es) of Drug Substance performed by Drug
Product manufacturer used during product development and stability studies, along with Certificate
of Analysis (CoA) of the same batch from Drug Substance / /Active Pharmaceutical Ingredient
manufacture, since the submitted COA of three batches of API are of 2020 while the drug product
batches were manufactured in 2018.
 Justify the use of overage in the formulation to compensate the potency of the product during process
loss.
 Justify the formulation which is different in terms of qualitative composition from that of innovator
product.
 Justify how you have performed comparative dissolution profile by taking only three time points,
also justify how 30, 45 and 60 minutes time point was selected during the CDP studies. Also clarify
why the initial time point was taken at 30 minutes for an immediate release dosage form.
 Provide detailed analytical method along with dissolution parameters used during the comparative
dissolution profile study. Also provide detailed results of comparative dissolution profile studies.
 Justify how mixing time has been finalized during the process validation studies.
 Justify why the test for water content is not performed for the drug product.
 Justify how you have performed dissolution test since your submitted method of analysis for this test
does not provide details for sample solution preparation or standard preparation. Furthermore no
formula for calculation of the results is provided.
 Justify why the analytical method for dissolution test for cefixime capsule is based on UV method
instead of using HPLC method which have been used by the innovator product as well as also
specified in JP monograph.
 Justify why the assay test is performed using UV method while the method of analysis of drug
substance manufacturer and the innovator product is based on HPLC method. Furthermore the JP
monograph also specifies HPLC test for assay method for cefixime capsule.
 Justify the analytical method validation studies which have been performed at totally different
concentrations than that specified in the assay method. The assay method specify that the
concentration of sample and standard solution is 0.02mg/ml while the validation studies have been
performed at very high concentrations.
 The process validation studies have been conducted on three batches having 10,000 capsule batch
size. While the batch size of the commercial batches for which stability study data is submitted,
ranges from 25,000 to 60,000 Capsule. Justification is required in this regard.
 Provide COA of the reference standard / working standard actually used in the analysis of drug
product in section 3.2.P.6, since you have submitted USP certificate for Lot No. R03930 which was
valid till 31-10-2019. Further submit evidence of purchase of the particular lot number of USP
reference standard.
 Specify the date of initiation of stability studies for all the stability batches.
 Justify why weight variation test is not performed during the stability studies.
 Justify how the results of assay and dissolution test at initial time point is different at both real time
and accelerated conditions.
 Justify why you have mentioned not applicable against “Reference of previous approval of
applications with stability study data of the firm (if any)” since various inspections of bio labs have
been conducted to verify the stability study data.
 Submit copy of commercial invoice for evidence of purchase of each batch of drug substance that
have been used in the analysis of each batch of drug product.
 Batch 261 was manufactured on 05-2018, the initial testing of real time studies was conducted on
04-07-2018 while the accelerated stability testing of initial time point was conducted on 15-05-2018.
Justify how this stability design is considered appropriate where different testing has been conducted
for initial studies, moreover the testing time for both accelerated and real time stability studies have
difference of approximately 2 months.
 Submit batch manufacturing record (BMR) of the three batches for which stability study data has
been submitted, since the submitted BMRs are of different batches.
within six months.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name VARICEF 100mg/5ml Dry Suspension
Pharmaceutical form of applied drug Almost pink colored powder having strawberry
flavour powder for reconstitution
product.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Karchi.
Description of Pack
Alu-alu blister
Batch No. D-006 D-018 D-022
Batch Size 80 Kg 10125 packs 5000 bottles
No. of Batches 03
data sheets etc.
Evaluation by PEC:
annexures.
 You have mentioned innovator’s specification in section 1.5.6 in module 1 while the drug product
monograph is available in USP. Revise the specifications along with submission of requisite fee.
 Justify how your unit formula containing 0.685gm of drug substance is equivalent to 100mg cefixime
base per 5ml after reconstitution. Further specify which is the unit which has been taken as reference
for your formulation.
product Suprax suspension.
 Innovator product has not used sodium citrate which is used in your formulation as preservative
along with sodium benzoate. Justify the use of two different preservatives without determining the
preservative effectiveness.
 The acceptance criteria for pH is 2.5 to 4.5 while your compatibility results specifies that after
reconstitution with the recommended diluent / solvent, the pH is 5.08 which lies outside the
acceptance criteria. Justify how you have passed this formulation and performed stability studies on
the same formulation.
 The process validation studies have been conducted on three batches having 5000 bottles batch size.
While the batch size of the commercial batches for which stability study data is submitted, ranges
from as low as 7500 and as high as 60,000 bottles. Justification is required in this regard.
 Submit detailed method of analysis of the drug product in section 3.2.P.5.2 instead of submitting
print of USP monograph.
 Submit exact details of the assay preparation since the words “Reconstitute sample as directed n the
labelling” should not be used in the method adopted by a firm. Instead provide details about the
exact diluent along with volume in which reconstitution is to be carried out.
 Justify the analytical method verification studies without performing test or specificity and precision.
Further also specify the exact concentration of solutions of 50%, 100% and 150% solutions used in
the analysis of accuracy and recovery test.
product in section 3.2.P.6.
 You have provided batch release certificate for batch D-220, D-221 and D-222 in section 3.2.P.5.4
while provided stability study data for batch D-006, D-018 and D-022 in section 3.2.P.8.3.
Clarification is required in this regard.
 Provide batch size of Batch D-006 in terms of number of bottles instead of providing batch size in
terms of Kg.
 You have submitted that API lot used in manufacturing of stability batches is 18CF10035 while
submitted COA of totally different batches in section 3.2.S.4.4. Justify why data was not submitted
in line with the guidance document issued by Registration Board.
 Justify why only 3 chromatographs of the standard solution was run while USP General chapter
<621> recommends that five replicates of standard solution should be used for system suitability
studies.
 Provide raw data sheets showing calculation of the results during the stability studies for all batches.
 Justify why the stability study data is section 3.2.P.8.3 is not submitted as per the guidance document
issued by Registration Board.
o Compliance Record of HPLC software 21CFR & audit trail reports on product testing
 Justify why BMR of different batches is submitted than that for which stability studies were
conducted.
within six months.
☐ Importer
☐ Export sale
The proposed proprietary name / brand name VARICEF 200mg/5ml Dry Suspension
Pharmaceutical form of applied drug Almost pink colored powder having strawberry
flavour powder for reconstitution
product.
30°C ± 2°C / 65 ± 5% RH for 24 months.
Karchi.
Description of Pack
Alu-alu blister
Batch No. 553 589 597
Batch Size 7500 packs 10000 packs 10000 packs
No. of Batches 03
data sheets etc.
Evaluation by PEC:
annexures.
 You have mentioned innovator’s specification in section 1.5.6 in module 1 while the drug product
monograph is available in USP. Revise the specifications along with submission of requisite fee.
 Justify how your unit formula containing 1.368gm of drug substance is equivalent to 200mg cefixime
base per 5ml after reconstitution. Further specify which is the unit which has been taken as reference
for your formulation.
product Suprax suspension.
 Innovator product has not used sodium citrate which is used in your formulation as preservative
along with sodium benzoate. Justify the use of two different preservatives without determining the
preservative effectiveness.
 The acceptance criteria for pH is 2.5 to 4.5 while your compatibility results specifies that after
reconstitution with the recommended diluent / solvent, the pH is 5.08 which lies outside the
acceptance criteria. Justify how you have passed this formulation and performed stability studies on
the same formulation.
 The process validation studies have been conducted on three batches having 5000 bottles batch size.
While the batch size of the commercial batches for which stability study data is submitted, ranges
from as low as 3000 and as high as 10,000 bottles. Justification is required in this regard.
 Submit detailed method of analysis of the drug product in section 3.2.P.5.2 instead of submitting
print of USP monograph.
 Submit exact details of the assay preparation since the words “Reconstitute sample as directed n the
labelling” should not be used in the method adopted by a firm. Instead provide details about the
exact diluent along with volume in which reconstitution is to be carried out.
 Justify the analytical method verification studies without performing test or specificity and precision.
Further also specify the exact concentration of solutions of 50%, 100% and 150% solutions used in
the analysis of accuracy and recovery test.
product in section 3.2.P.6.
 You have provided batch release certificate for different batches in section 3.2.P.5.4 while the
stability study data of different batches is submitted in section 3.2.P.8.3. Clarification is required in
this regard.
 Provide batch size of Batch D-006 in terms of number of bottles instead of providing batch size in
terms of Kg.
 You have submitted that API lot used in manufacturing of stability batches is 18CF10035 while
submitted COA of totally different batches in section 3.2.S.4.4. Justify why data was not submitted
in line with the guidance document issued by Registration Board.
 Justify why only 3 chromatographs of the standard solution was run while USP General chapter
<621> recommends that five replicates of standard solution should be used for system suitability
studies.
 Provide raw data sheets showing calculation of the results during the stability studies for all batches.
 Justify why the stability study data is section 3.2.P.8.3 is not submitted as per the guidance document
issued by Registration Board.
o Compliance Record of HPLC software 21CFR & audit trail reports on product testing
 Justify why BMR of different batches is submitted than that for which stability studies were
conducted.
 Justify the criteria for selecting batch number and batch size of your product, since different format
of batch numbers have been used for different batches, while significant difference in batch size also
exist among various production scale batches.
within six months.
1095.Name, address of Applicant / Marketing M/s Hygeia Pharmaceuticals, Plot No. 295,
Authorization Holder Industrial Triangle Kahuta Road Islamabad.
Name, address of Manufacturing site. M/s Rotex Pharma (Pvt) Ltd, Plot # 206 & 207,
☐ Importer
GMP status of the firm Rotex pharma: GMP certificate issued on the
basis of inspection dated 12-08-2020
000651 of M/s Rotex Pharma Islamabad dated 13-
06-2017 specifying dry powder injection
☐ Export sale
The proposed proprietary name / brand name MEROMAX 500mg Injection
Pharmaceutical ingredient (API) per unit Meropenem trihydrate eq to
meropenem……500mg
Pharmaceutical form of applied drug White to off white powder filled in clear glass vials
Name and address of API manufacturer.
Module-III Drug Substance:
Dissolution Profile
product
Manufacturer of API
API Lot No.
Description of Pack
Glass vial
Batch No.
Batch Size
Manufacturing Date
Date of Initiation
No. of Batches 03
data sheets etc.
Evaluation by PEC:
The product development and stability study data of the contract manufacturer was considered by
Registration Board in its 312nd meeting and observed that the contract manufacturer has not performed
complete product development studies, the specifications adopted by the manufacturer throughout stability
studies were not according to USP and that the stability batches have also expired. Accordingly, the Board
deferred for following submissions:
 Scientific justification for not performing compatibility studies with the recommended diluent.
 Scientific justification for using an entirely different formula for calculation of assay resultsof
 Scientific justification for not performing test of sodium content.
 Scientific justification for not performing criticial tests like constituted solution, and loss on drying
during the stability studies.
 Scientific justification for performing stability studies in which the test of bacterial endotoxin and
sterility is not performed at 6 months time interval.
 Scientific justification for using only 3 chromatograms of the standard solution for HPLC testing
while USP General chapter <621> recommends that five replicates of standard solution should be
used for system suitability studies.
 Evidence of purchase of atomic absorption spectrophotometer including commercial invoice and
Installation Qualification (IQ) and Operational Qualification (OQ) of atomic absorption along with
performance data for sodium content test on stability batches.
 Submission of fee for pre-registration changes in the drug product specifications.
The Board further decided that the submitted stability study data is not acceptable and directed the contract
manufacturer to either perform complete product development and stability studies as per USP specifications
or submit aforementioned data for commercial batches manufactured as per USP specifications.
within six months.
1096.Name, address of Applicant / Marketing M/s Stanley Pharmaceuticals (Pvt) Ltd. 84-B
Authorization Holder Industrial Estate Hayatabad Peshawar.
Name, address of Manufacturing site. M/s Stanley Pharmaceuticals (Pvt) Ltd. 84-B
Industrial Estate Hayatabad Peshawar.
☐ Importer
Evidence of approval of manufacturing facility
☐ Export sale
Dy. No. and date of submission Dy. No. 26756 : 11-12-2019
The proposed proprietary name / brand name Pedrol CF Day Caplet
Strength / concentration of drug of Active Each uncoated caplet contains:
Pharmaceutical ingredient (API) per unit Paracetamol ………….500mg
Phenylephrine HCl……..5mg
Pharmacotherapeutic Group of (API)
Reference to Finished product specifications
Proposed Pack size
Proposed unit price
The status in reference regulatory authorities Medreich Cold and Flu Relief PE Day tablet (TGA
Approved)
For generic drugs (me-too status) Panadol CF Day Caplet by GSK (Reg # 094797)
Name and address of API manufacturer.
Module-III Drug Substance:

Dissolution Profile
product
Manufacturer of API
API Lot No.
Description of Pack
Frequency Accelerated: 0, 1, 2, 3, 4, 6 (Months)
Batch Size 2000 tablet 2000 tablet 2000 tablet
No. of Batches 03
# Documents To Be Provided Status
1. COA of API
2. Approval of API by regulatory authority of

country of origin or GMP certificate of API
manufacturer issued by regulatory authority
of country of origin.
3. Protocols followed for conduction of stability
study and details of tests.
4. Data of 03 batches will be supported by
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc.
6. All provided documents will be attested
(name, sign and stamp) for ensuring
authenticity of data / documents.
7. Commitment to continue real time stability
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification
Rules, 1978.
REMARKS OF EVALUATOR
 Drug substance related information including name and address of API manufacturer, and approval
of manufacturing facility of API manufacturer by regulatory body of the concerned country as per
the requirements of sub section 1.6.5 needs to be submitted.
 Quality overall summary (QOS) in module 2 needs to be submitted as per WHO QOS - PD template.
 Complete information related to drug substance as per requirement of sub section 3.2.S needs to be
submitted in the light of guidance document approved by Registration Board in its 293rd meeting.
 Complete information related to drug product as per requirement of sub section 3.2.P needs to be
submitted in the light of guidance document approved by Registration Board in its 293rd meeting.
 Submit stability study data of 3 batches of drug product along with associated data / documents (as
per 6 points checklist) as per the guidance document approved by Registration Board in its 293 rd
meeting.
within six months.
Item No. XVII: Agenda of Evaluator II:
Case No. 01 Registration applications of newly granted DML or New section (Human
a. New cases
1097. Name and address of M/s Barrett Hodgson Pakistan Pvt Ltd. F/423, SITE, Karachi
manufacturer / Applicant
Brand Name + Dosage Form + T penol XR 200mg Tablet
Strength
Composition Each Film Coated Extended Release
Tablet Contains:
Tapentadol HCl …..…200mg
Diary No. Date of R& I & fee Dy.No 13601 dated 07-03-2019 Rs.20,000/- dated 06-03-2019
Pharmacological Group Analgesics, Opiods
Type of Form Form-5
Approval status of product in Approved by USFDA
Me-too status (with strength and --
dosage form)
GMP status GMP certificate issued based on inspection conducted on 06-12-
2021
Remarks of the Evaluator II:
 Submit stability study data as per the guidelines approved in 293rd meeting of Registration Board.
Decision: Deferred for submission of stability studies data as per checklist of 293 rd meeting of DRB
within 6 months.
Brand Name + Dosage Form + T penol 100mg Tablet
Strength
Type of Form Form-5
dosage form)
2021
within 6 months.
Strength
Type of Form Form-5
dosage form)
2021
Decision: Deferred for submission of stability studies data as per checklist of 293rd meeting of DRB
within 6 months.
Strength
Diary No. Date of R& I & fee Dy.No 13605 dated 07-03-2019, Rs.20,000/- dated 06-03-2019
Type of Form Form-5
dosage form)
2021
within 6 months.
Brand Name + Dosage Form + Hepvir B Tablet 0.5mg
Strength
Entecavir….…0.5mg
Pharmacological Group Antivirals for systemic use
Type of Form Form-5
Approval status of product in Approved by MHRA of UK
Me-too status (with strength and Cavirent Tablet 0.5mg by M/s CKD Pharmaceuticals
dosage form) Reg#092969)
2021
II
Remarks of the Evaluator :
 Submit revised label claim as per innovator product declaring the hydrate form of Entecavir, along
with master formulation and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP dated
07th May, 2021.
 Firm has submitted revised label claim along with master formulation and fee of Rs. 30,000/- vide
deposit slip# 32870446717:
“Each Film Coated Tablet Contains:
Entecavir monohydrate eq. to Entecavir ….… 0.5mg”

Entecavir monohydrate eq. to Entecavir ….… 0.5mg”
Brand Name + Dosage Form + Hepvir B Tablet 1mg
Strength
Entecavir….…1mg
Pharmacological Group Antivirals for systemic use
Type of Form Form-5
Me-too status (with strength and Cavirent Tablet 1mg by M/s CKD Pharmaceuticals (Reg#092968)
dosage form)
2021
 Submit revised label claim as per innovator product declaring the hydrate form of Entecavir, along
07th May, 2021.
 Firm has submitted revised label claim along with master formulation and fee of Rs. 30,000/- vide
deposit slip# 235793008:
Entecavir monohydrate eq. to Entecavir ….… 1mg”

Entecavir monohydrate eq. to Entecavir ….… 1mg”
Brand Name + Dosage Form + Barifer Solution for Injection 1000mg/10ml
Strength
Composition Each 10ml Ampoule Contains:
Iron as Iron (III) Isomaltoside 1000……..1000mg
Pharmacological Group Iron parenteral preparation
Type of Form Form-5
Me-too status (with strength and
dosage form)
2021
II
Evidence of applied formulation/drug in the applied fill volume of 10ml, already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm or submit stability
study data as per the guidelines approved in 293rd meeting of Registration Board along with Form 5D and
differential fee as per notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
Decision: Deferred for evidence of applied formulation/drug in the applied fill volume of 10ml,
already approved by DRAP (generic / me-too status) alongwith registration number, brand name
and name of firm or submit stability study data as per the guidelines approved in 293rd meeting of
Registration Board along with Form 5D and differential fee as per notification No. F.7-11/2012-
B&A/DRAP dated 07th May, 2021.
Strength
Type of Form Form-5
dosage form)
2021
Strength
Type of Form Form-5
dosage form)
2021
II
Strength
Type of Form Form-5
Me-too status (with strength and Wisofer Injection of Wnsfield (Reg.# 078521)
dosage form)
2021
Decision: Approved with Innovator’s specifications. The firm shall submit fee of Rs. 7500/- for
 The firm shall inform area FIDfor sampling of first commercial scale batch for testing by
CDL Karachi in comparison to innovator drug product i.e., Monofer injection and after
satisfactory report by CDL, product will be marketed.
Brand Name + Dosage Form + Amdap 10/1.5mg Tablet
Strength
Composition Each Film Coated, bilayer, modified release tablet contains:
Amlodipine as Besylate…….10mg
Indapamide……..1.5mg
Pharmacological Group Antihypertensive diuretic +Calcium antagonist
Type of Form Form-5
Approval status of product in Approved by ANSM of France
Me-too status (with strength and Natrilam tablets 10mg of M/s Serveir Research & Pharmaceuticals
dosage form) Pakistan (Reg.# 078521)
2021
within 6 months.
Brand Name + Dosage Form + Amdap 5/1.5mg Tablet
Strength
Composition Each Film Coated, bilayer, modified release tablet contains:
Amlodipine as Besylate…….5mg
Indapamide……..1.5mg
Pharmacological Group Antihypertensive diuretic +Calcium antagonist
Type of Form Form-5
2021
II
within 6 months.
Brand Name + Dosage Form + V-Day Syrup
Strength
Composition Each 10 ml Contains:
Glutamic Acid...3mg
L-Lysine...10mg
L-Ornithine...5mg
Methionine...5mg
L-Aspartate...5mg
Calcium...15mg
Chromium...5Mcg
Cobalt...25Mcg
Copper...1mg
Iodine...50Mcg
Iron...10mg
Maganese...2mg
Magnesium...30mg
Molybdenum...5Mcg
Potassium...2mg
Selenium...3Mcg
Zinc...5mg
Vitamin A...0.9mg
Vitamin B1...1.5mg
Vitamin B2...1.2mg
Vitamin B6...1mg
Vitamin B12...3Mcg
Vitamin C...50mg
Vitamin D...10Mcg
Vitamin E...3mg
Nicotinamide...10mg
Panthenol...5mg
Folic Acid...0.1mg
Pharmacological Group Multi vitamin
Type of Form Form-5
dosage form)
2021
 Evidence of approval of applied formulation in reference regulatory authorities/agencies which
were declared/approved by the Registration Board.
1110. Name and address of M/s Briell Pharmaceutical (Pvt) Ltd. 538C Sundar Industrial
manufacturer / Applicant Estate Multan Road, Lahore.
Brand Name + Dosage Form + Urisol 5mg Tablet
Strength
Solifenacin Succinate …….. 5mg
Pharmacological Group Urinary antispasmodics
Type of Form Form-5
Finished product Specifications Manufacturer specifications
Pack size & Demanded Price As per DRAP policy
GMP status GMP certificate issued on basis of inspection conducted on 20-10-
22
Brand Name + Dosage Form + Urisol 10mg Tablet
Strength
Solifenacin Succinate …….. 10mg
Pharmacological Group Urinary antispasmodics
Type of Form Form-5
Me-too status (with strength and Solfine Tablet 10 mg of M/s Regal Pharmaceuticals (Reg.
dosage form) No.081959)
22
Brand Name + Dosage Form + Genac 50mg Tablet
Strength
Composition Each Enteric Coated Tablet Contains:
Diclofenac Sodium……..50mg
Pharmacological Group Antirheumatic
Type of Form Form-5
Pack size & Demanded Price As per policy of DRAP
Approval status of product in Voltaren approved by USFDA
Me-too status (with strength and Dicmaf 50mg Tablet of M/s Mafins, Karachi (Reg.# 079884)
dosage form)
22
Decision: Approved.
Brand Name + Dosage Form + Genac 100mg SR Tablet
Strength
Pharmacological Group Antirheumatics
Type of Form Form-5
Me-too status (with strength and Medifenac SR 100mg Tablet of M/s M/s. Mediate
dosage form) Pharmaceuticals, Karachi (Reg.# 048703)
22
Decision: Approved.
Brand Name + Dosage Form + Gabfil 100mg Capsule
Strength
Pregabalin…100mg
Pharmacological Group Anti-epileptics
Type of Form Form 5
Finished product Specifications Manufacturers specification
Me-too status (with strength and Gabica 100mg Capsule by M/s Getz Pharma (Reg#047366)
dosage form)
22
Decision: Approved with BP specifications. The firm shall submit fee of Rs. 7500/- for
Brand Name + Dosage Form + Gabfil 50mg Capsule
Strength
Pregabalin…50mg
Pharmacological Group Anti-epileptics
Type of Form Form 5
Finished product Specifications Manufacturers specification
Me-too status (with strength and Gabica 50mg Capsule by M/s Getz Pharma
dosage form)
22
1116. Name and address of M/s Biogen Pharma. 8-Km, Chakbeli Road, Rawat,
manufacturer / Applicant Rawalpindi, Pakistan
Brand Name + Dosage Form + Flozamin 5/1000mg Tablet
Strength
Empagliflozin……5mg
Metformin HCl….…1000mg
Type of Form Form-5
Me-too status (with strength and Diajard-M Tablet by Highnoon
dosage form)
GMP status Panel inspection for renewal of DML of M/s. Biogen Pharma,
Rawat conducted on 25-11-2019 & 12-12-2019 concluded that
the panel unanimously recommended the renewal of DML
within 6 months.
Brand Name + Dosage Form + Flozamin 12.5/850mg Tablet
Strength
Empagliflozin……12.5mg
Type of Form Form-5
dosage form)
Rawat conducted on 25-11-2019 & 12-12-2019 concluded that
the panel unanimously recommended the renewal of DML
within 6 months.
Brand Name + Dosage Form + Flozamin 5/850mg Tablet
Strength
Empagliflozin……5mg
Type of Form Form-5
dosage form)
Rawat conducted on 25-11-2019 & 12-12-2019 concluded that the
panel unanimously recommended the renewal of DML
within 6 months.
Brand Name + Dosage Form + Flozamin 12.5/1000mg Tablet
Strength
Empagliflozin……12.5mg
Type of Form Form-5
dosage form)
within 6 months.
Brand Name + Dosage Form + Empazin 10mg Tablet
Strength
Empagliflozin ….… 10mg
Diary No. Date of R& I & fee Dy. No 13776 dated 07-03-2019 Rs.20,000/- dated 07-03-2019
Type of Form Form-5
Me-too status (with strength and Empoli Tablet by Sami
dosage form)
II
within 6 months.
1121. Name and address of M/s Linta Pharmaceuticals Pvt Ltd. Plot No. 03, Street No S-5,
manufacturer / Applicant National Industrial Zone, Rawat, Islamabad
Brand Name + Dosage Form + Emplin Tablet 25mg
Strength
Type of Form Form-5
dosage form)
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 acceptable level of
GMP standard.
 Latest GMP inspection report conducted within a period of last three years.
within 6 months.
Brand Name + Dosage Form + Emplin Tablet 10mg
Strength
Type of Form Form-5
dosage form)
GMP standard.
within 6 months.
Brand Name + Dosage Form + Emplin M Tablet 12.5/500mg
Strength
Metformin…….500mg
Type of Form Form-5
dosage form)
GMP standard.
 Revise your label claim as per the reference product along with submission of requisite fee as per
within 6 months.
Brand Name + Dosage Form + Emplin M Tablet 12.5/850mg
Strength
Metformin……..850mg
Type of Form Form-5
dosage form)
GMP standard.
II
within 6 months.
1125. Name and address of M/s Fassgen Pharmaceuticals Plot No. 67/1-A, Phase-III,
manufacturer / Applicant Industral Estate, Hattar
Brand Name + Dosage Form + Emzin 10mg Tablet
Strength
Type of Form Form-5
dosage form)
GMP status
within 6 months.
1126. Name and address of M/s Horizon Healthcare (Pvt) Ltd. Plot No.35-A, Small
manufacturer / Applicant Industrial Estate, Taxila, Pakistan
Brand Name + Dosage Form + Empazin Plus SR 12.5/1000mg Tablet
Strength
Metformin HCl (Sustained Release)…1000mg
Type of Form Form-5
Me-too status (with strength and Xenglu-Met XR Tablet by Hilton
dosage form)
GMP status
within 6 months.
1127. Name and address of M/s Baxter Pharmaceuticals. A-1/A, Scheem No.33,Phase-
manufacturer / Applicant 1,S.I.T.E,Super Highway, Karachi
Brand Name + Dosage Form + Dexozol 60mg Tablet
Strength
Dexlansoprazole….…60mg
Type of Form Form 5
Finished product Specifications Firm has claimed in house specification
Me-too status (with strength and Razodex Capsule of Getz
dosage form)
GMP status
 Submission of stability study data of three batches as per the guidelines and checklist approved by
Registration Board in its 293rd meeting.
within 6 months.
1128. Name and address of M/s Bosch Pharmaceuticals (Pvt.) Ltd. Bosch House 221,
manufacturer / Applicant Sector 23, Korangi Industrial Area, Karachi, Pakistan
Brand Name + Dosage Form + Dexizol 60mg Capsule
Strength
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1129. Name and address of M/s Bosch Pharmaceuticals (Pvt.) Ltd. Bosch House 221,
manufacturer / Applicant Sector 23, Korangi Industrial Area, Karachi, Pakistan
Brand Name + Dosage Form + Dexizol 30mg Capsule
Strength
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1130. Name and address of M/s Hamaz Pharmaceuticals Pvt Ltd .Business City Plaza,
manufacturer / Applicant Hall # 1, 2nd Floor, Bosan Road, Multan, Pakistan
Brand Name + Dosage Form + Mazodex Capsule 60mg
Strength
Dexlansoprazole……..60mg
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1131. Name and address of M/s Hisun Pharmaceutical Industries. Plot No. 37-A, R-2,
manufacturer / Applicant Industrial Estate Gadoon, Sawabi, Kpk, Pakistan
Brand Name + Dosage Form + Dexlansip 30mg Capsule
Strength
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1132. Name and address of M/s Hisun Pharmaceutical Industries. Plot No. 37-A, R-2,
manufacturer / Applicant Industrial Estate Gadoon, Sawabi, Kpk, Pakistan
Brand Name + Dosage Form + Dexlansip 60mg Capsule
Strength
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1133. Name and address of M/s Libra Pvt Ltd 77-Peshawar Industrial Estate, Hayatabad
manufacturer / Applicant Peshawar
Brand Name + Dosage Form + Lanxodex DR 30mg Capsule
Strength
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1134. Name and address of M/s Libra Pvt Ltd 77-Peshawar Industrial Estate, Hayatabad
manufacturer / Applicant Peshawar
Brand Name + Dosage Form + Lanxodex DR 60mg Capsule
Strength
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1135. Name and address of M/s Marvi Pharmaceuticals. Plot No. 70, Sector 24, Korangi
manufacturer / Applicant Industrial Area, Karachi, Pakistan
Brand Name + Dosage Form + Dexazolan 60mg Capsule
Strength
Dexlansoprazole Pellets Eq. To Dexlansoprazole…60mg
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1136. Name and address of M/s MBL Pharma. B-77-A, H.I.T.E, Hub, Pakistan
Brand Name + Dosage Form + Dexlan 60mg Capsule
Strength
Dexlansoprazole As Dexlansoprazole Delayed Release
Pellets…60mg
Type of Form Form 5
dosage form)
GMP status Last inspection report conducted on 31-5-2022 recommends
renewal of DML.
within 6 months.
Brand Name + Dosage Form + Dexlan 30mg Capsule
Strength
Dexlansoprazole As Dexlansoprazole Delayed Release
Pellets…30mg
Type of Form Form 5
dosage form)
renewal of DML.
within 6 months.
1138. Name and address of M/s Medicon Pharmaceuticals Pvt Ltd. Industrial Estate,
manufacturer / Applicant Jamrud Road, Peshawar, Pakistan
Brand Name + Dosage Form + Dexazole 60mg Capsule
Strength
Dexlansoprazole Dual Delayaed Release Pellets Eq To
Dexlansoprazole…….60mg
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1139. Name and address of M/s Medicon Pharmaceuticals Pvt Ltd. Industrial Estate,
manufacturer / Applicant Jamrud Road, Peshawar, Pakistan
Brand Name + Dosage Form + Dexazole 30mg Capsule
Strength
Dexlansoprazole Dual Delayaed Release Pellets Eq To
Dexlansoprazole…….30mg
Type of Form Form 5
dosage form)
GMP status
within 6 months.
1140. Name and address of M/s Cunningham Pharmaceuticals Pvt Ltd. Plot # 81, Sunder
manufacturer / Applicant Industrial Estate, Raiwind Road Lahore, Pakistan
Brand Name + Dosage Form + Apicure 5mg Tablet
Strength
Apixaban…….5mg
Pharmacological Group Antithrombotic agents
Type of Form Form 5
Me-too status (with strength and Apiban tablet of M/s Highnoon.
dosage form)
GMP status Firm has submitted copy of GMP certificate of M/s Cunningham
Pharmaceuticals (Pvt) Ltd dated 19-04-2019 based on the
within 6 months.
1141. Name and address of M/s Cunningham Pharmaceuticals Pvt Ltd. Plot # 81, Sunder
Brand Name + Dosage Form + Apicure 2.5mg Tablet
Strength
Apixaban…….2.5mg
Pharmacological Group Antithrombotic agents
Type of Form Form 5
Me-too status (with strength and Apiban tablet of M/s Highnoon.
dosage form)
GMP status Firm has submitted copy of GMP certificate of M/s Cunningham
Pharmaceuticals (Pvt) Ltd dated 19-04-2019 based on the
within 6 months.
Brand Name + Dosage Form + Adcon 150mg Capsule
Strength
Fluconazole……150mg
Type of Form Form 5
Approval status of product in Azocan 150 of M/s FDC International Ltd. approved by MHRA
Reference Regulatory Authorities of UK
Me-too status (with strength and Fantizol Capsule by M/ Apex Karachi. (Reg#073551)
dosage form)
22
 Firm has applied in-house specifications whereas Pharmacopoeial monograph is available for
applied formulation.
 Firm has submitted revised drug product specifications as per BP monograph, without submission
of fee.
Brand Name + Dosage Form + Lamisil 125mg Tablet
Strength
Terbinafine HCl…..…125mg
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per PRC
Me-too status (with strength and Mycoderm 125mg Tablet by M/s Nabiqasim Karachi. (Reg.#
dosage form) 081045)
22
 Submit revised label claim as per innovator product declaring label claim in terms of Terbinafine,
and dosage form as uncoated tablet along with master formulation and relevant fee as per
Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
 Firm has submitted revised label claim as under along with submission of fee of Rs. 30,000/- vide
deposit slip# 111158062608.
“Each Tablet Contains:
Terbinafine as HCl…..…125mg”
Decision: Approve as per following label claim:

Terbinafine as HCl…..…125mg”
Brand Name + Dosage Form + Cozar 25mg Tablet
Strength
Pharmacological Group Angiotensin II antagonists
Type of Form Form-5
Me-too status (with strength and Bepsar 25mg Tablet by M/s Nabiqasim Karachi. (Reg.# 033384)
dosage form)
22
Decision: Approved.
Brand Name + Dosage Form + Ancid 100mg Tablet
Strength
Flurbiprofen……100mg
Type of Form Form-5
Me-too status (with strength and Strefen Tablets of Healers Pharmaceuticals (Reg.# 069733)
dosage form)
22
 Firm has submitted revised drug product specifications as per USP monograph, without
submission of fee.
Decision: Approved with USP specifications. The firm shall submit fee of Rs. 7500/- for
Brand Name + Dosage Form + Zanaflex 4mg Tablet
Strength
Tizanidine Hydrochloride…4mg
Pharmacological Group Centrally acting agent; muscle relaxant
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s; As per the brand leader
Me-too status (with strength and SN Skelax 4 mg Tablets by M/s SNB Pharma (Pvt) Ltd.
dosage form) (Reg#078413)
22
II
 Submit revised label claim as per innovator product declaring label claim in terms of Tizanidine,
Tizanidine as HCl…..…125mg”
Brand Name + Dosage Form + Cozar mg Tablet
Strength
Pharmacological Group Angiotensin II antagonists
Type of Form Form-5
Me-too status (with strength and Bepsar 25mg Tablet by M/s Nabiqasim Karachi. (Reg.# 033384)
dosage form)
22
Decision: Approved.
Brand Name + Dosage Form + Deflux 10mg Tablet
Strength
Domperidone…10mg
Pharmacological Group Peripheral dopamine receptor antagonist
Type of Form Form 5
Approved by TGA of Australia
Me-too status (with strength and Epodom 10mg Tablets of M/s Atlantic Pharmaceutical (Pvt.) Ltd,
dosage form) (Reg.# 062326)
22
Brand Name + Dosage Form + Hazar 25/100mg Tablet
Strength
Hydrochlorothiazide…25mg
Pharmacological Group Angiotensin II antagonists and diuretics
Type of Form Form 5
Approved by MHRA of UK
Co-Eziday Tablets of M/s Werrick Pharmaceutical
dosage form)
22
Decision: Approved.
Brand Name + Dosage Form + Zanaflex 2mg Tablet
Strength
Tizanidine Hydrochloride…2mg
Pharmacological Group Centrally acting agent; muscle relaxant
Type of Form Form-5
Me-too status (with strength and SN Skelax 4 mg Tablets by M/s SNB Pharma (Pvt) Ltd.
dosage form)
22
 Submit revised label claim as per innovator product declaring label claim in terms of Tizanidine,
Brand Name + Dosage Form + Icon 100mg Capsule
Strength
Itraconazole….…100mg
Pharmacological Group Anti-fungal
Type of Form Form-5
Me-too status (with strength and Mukil Capsule 100mg of M/s. Dyson Research Laboratories (Pvt)
dosage form) Ltd (Reg.# 055356)
22
 Submit source of pellets along with relevant documents. i.e., COA, GMP certificate of supplier
and stability studies data of the pellets as per Zone-Iva.
Decision: Approved. Firm shall submit source of pellets along with relevant documents. i.e., COA,
GMP certificate of supplier and stability studies data of the pellets as per Zone-IVA before issuance
Brand Name + Dosage Form + Metzone 5mg Tablet
Strength
Metolazone….…5mg
Pharmacological Group Sulfonamides
Type of Form Form-5
Me-too status (with strength and Metxone tablet 5mg (Reg.# 090699) of M/s Genome
dosage form)
22
within 6 months.
Brand Name + Dosage Form + Sensipar 30mg Tablet
Strength
Cinacalcet…30mg
Pharmacological Group Anti-parathyroid agent
Type of Form Form-5
dosage form)
22
within 6 months.
Brand Name + Dosage Form + Sensipar 60mg Tablet
Strength
Cinacalcet…60mg
Pharmacological Group Anti-parathyroid agent
Type of Form Form-5
dosage form)
22
within 6 months.
Brand Name + Dosage Form + Crestor 5mg Tablet
Strength
Rosuvastatin As Calcium…5mg
Pharmacological Group Cholestrol lowering medicine
Type of Form Form-5
Finished product Specifications Manufacturer Specifications
Me-too status (with strength and Rosat Tablets 5 mg by M/s Genera Pharma. (Reg.# 069984)
dosage form)
22
II
submission of fee.
Strength
Type of Form Form-5
Me-too status (with strength and Xplendid Tablets by M/s Pharmevo
dosage form)
22
II
submission of fee.
Strength
Type of Form Form-5
Me-too status (with strength and Xplendid Tablets by M/s Pharmevo
dosage form)
22
submission of fee.
1158. Name and address of M/s Briell Pharmaceutical (Pvt.) Ltd. 538C Sundar Industrial
Brand Name + Dosage Form + Vildamet 50/1000 mg Tablet
Strength
Vildagliptin…50mg
Pharmacological Group Antihyperglycemic agent
Type of Form Form-5
Me-too status (with strength and Galmet 50mg/1000mg Table M/s Vision Pharma (Ref# 081907)
dosage form)
22
Strength
Vildagliptin…50mg
Type of Form Form-5
dosage form)
22
Strength
Vildagliptin…50mg
Type of Form Form-5
dosage form)
22
Strength
Vildagliptin…50mg
Type of Form Form-5
dosage form)
22
Brand Name + Dosage Form + Vildaglip 50mg Tablet
Strength
Vildagliptin……50mg
Type of Form Form-5
Me-too status (with strength and Galza Table M/s CCL Pharma
dosage form)
22
Brand Name + Dosage Form + Adin 10mg Tablet
Strength
Loratadine…….10mg
Pharmacological Group Antihistamine
Type of Form Form-5
Me-too status (with strength and Senergy OD 10mg tablet, Highnoon Labs. Reg. No. 017672.
dosage form)
22
 Submit revised label claim as per innovator product declaring the dosage form as uncoated tablet
along with master formulation and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP
dated 07th May, 2021.
deposit slip# 33347719539 along with change of specifications to USP
Loratadine…..…10mg”
Loratadine…..…10mg”
Brand Name + Dosage Form + Adin 5mg/5ml Oral Solution
Strength
Loratadine…5mg
Type of Form Form-5
Me-too status (with strength and Victrin 1mg/ml Liquid Syrup by M/s Barret Hodgson
22
submission of fee.
Brand Name + Dosage Form + Arcos 60mg Tablet
Strength
Etoricoxib…60mg
Diary No. Date of R& I & fee Dy .No 16038 dated 07-03-2019 Rs.20,000/- dated 07-03-2019
Type of Form Form-5
Me-too status (with strength and Etoria 60mg Table of M/s Hygeia Pharmaceuticals, Islamabad
22
II
Brand Name + Dosage Form + Estin 10mg Tablet
Strength
Ebastine…10mg
Pharmacological Group Anti-histamine
Type of Form Form-5
Approval status of product in Approved by ANMS of France
Me-too status (with strength and Clubex 10mg Tablets of M/s Welmark Pharmaceuticals. (Reg.#
22
 Firm has submitted revised drug product specifications as per JP monograph, without submission
of fee.
Decision: Approved with JP specifications. The firm shall submit fee of Rs. 7500/- for correction/pre-
approval change in product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-
05-2021.
Brand Name + Dosage Form + Prevacid 30mg Capsule
Strength
Lansoprazole Enteric Coated Pellets Eq. To
Lansoprazole….…30mg
Pharmacological Group Proton pump inhibitor.
Type of Form Form-5
Pack size & Demanded Price 2 x 7’s; As per SRO
Me-too status (with strength and Leazole 30mg Capsules of M/s Leads Pharma (Pvt.) Ltd.
dosage form) (Reg.#035891)
22
and stability studies data of the pellets as per Zone-IVa.
 Firm has submitted relevant documents for source of pellets from M/s Vision pharmaceuticals.
Decision: Approved.
Brand Name + Dosage Form + Haemfil 100mg/5ml Syrup
Strength
Polysaccharide Iron Complex……100mg
Pharmacological Group Anti-anaemic
Type of Form Form-5
Approval status of product in Not applicable
Me-too status (with strength and Iron- Sac Syrup of M/s Lowitt Pharmaceutical, Peshawar
dosage form) 056655
22
 Submit revised label claim declaring the strength in terms of the elemental Iron alongwith relevant
fee as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
deposit slip# 306977295
Each 5ml Contains:
Polysaccharide Iron Complex eq. to elemental Iron ……100mg
Each 5ml Contains:
Polysaccharide Iron Complex eq. to elemental Iron ……100mg
Brand Name + Dosage Form + Malafan 80/480 mg Tablet
Strength
Artemether ……… 80mg
Lumefantrine …..… 480mg
Pharmacological Group Antimalarial
Type of Form Form-5
Finished product Specifications IP
Approval status of product in WHO prequalified formulation
Me-too status (with strength and Artem -DS Plus Tablets 80/480 of M/s Hilton Pharma, Karachi
22
 Reference product is available as uncoated tablet, whereas firm has applied for Film coated tablet
hence submit revised label claim declaring the dosage form as uncoated tablet, alongwith relevant
Artemether………80mg
Lumefantrine…..…480mg
Artemether ……… 80mg
Lumefantrine …..… 480mg”
Brand Name + Dosage Form + Genac-K 50mg Tablet
Strength
Diclofenac Potassium….…50mg
Pharmacological Group Antirheumatic
Type of Form Form-5
Me-too status (with strength and Dicota 50 Tablet of M/s Linz Karachi, (Reg.# 073524)
dosage form)
22
Decision: Approved.
Brand Name + Dosage Form + Irosoft Chewable Tablet
Strength
Iron III Hydroxy Polymaltose Complex Eq. To Elemental Iron
….…100mg
Folic Acid …… 0.35mg
Type of Form Form-5
Approval status of product in --
Me-too status (with strength and Ipomalt -F Tablets of M/s Rock Pharmaceutical Laboratories
dosage form) (Pvt) Ltd. (Reg.# 077301)
22
1172. Name and address of M/s Alliance Pharmaceutical Pvt Ltd. 112 A, Hayatabad
manufacturer / Applicant Industrial Estate, Peshawar
Brand Name + Dosage Form + Mevodip V 10/160mg Table
Strength
Amlodipine Besylate …..…10mg
Valsartan…….160mg
Type of Form Form 5
Me-too status (with strength and Valpine Tablets 10/160mg by M/s Fassgen Pharmaceuticals,
dosage form) (Reg. No. 073303)
GMP status --
II
 Submit revised label claim as per innovator product, along with master formulation and relevant
 Latest inspection report conducted within last three years shall be submitted.
Decision: Approved. Registration letter will be issued upon submission of following;
 Revised label claim as per innovator product, along with master formulation and relevant
Brand Name + Dosage Form + Dexifen 200mg Tablet
Strength
Dexibuprofen………200mg
Type of Form Form 5
Finished product Specifications Manufacturer's Specification
Me-too status (with strength and Dexipin 200mg tablet of AGP
dosage form)
GMP status --
II
B&A/DRAP dated 07-05-2021 along with latest GMP inspection report conducted within last three
years before issuance of registration letter.
Strength
Type of Form Form 5
Me-too status (with strength and Dexipin tablet of AGP
dosage form)
GMP status --
II
Strength
Type of Form Form 5
Me-too status (with strength and Dexipin tablet of AGP
dosage form)
GMP status --
Brand Name + Dosage Form + Soval 250mg Tablet
Strength
Divalproex Sodium Eq. To Valproic Acid…250mg
Type of Form Form 5
Me-too status (with strength and Divanza tablet of m/s Hiranis
dosage form)
GMP status --
Clarification shall be submitted whether applied formulation is delayed release/ extended release or
otherwise, along with relevant annexures of Form 5.
Decision: Deferred for clarification whether applied formulation is delayed release/ extended release
or otherwise, along with submission of relevant annexures of Form 5.
Brand Name + Dosage Form + Soval 500mg Tablet
Strength
Divalproex Sodium Eq. To Valproic Acid…500mg
Type of Form Form 5
Me-too status (with strength and Divanza tablet of m/s Hiranis
dosage form)
GMP status --
Clarification shall be submitted whether applied formulation is delayed release/ extended release or
otherwise, along with relevant annexures of Form 5.
Decision: Deferred for clarification whether applied formulation is delayed release/ extended release
or otherwise, along with submission of relevant annexures of Form 5.
Brand Name + Dosage Form + Isotran 10mg Capsule
Strength
Isotretinoin…10mg
Pharmacological Group Retinoids
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s; As per SRO
1. Approved in US-FDA
Me-too status (with strength and Acnewin Capsule 10mg of Wnsfield Pharmaceuticals (Reg.#
GMP status --
II
 Clarification shall be submitted whether applied formulation is hard gelatin capsule or soft gelatin
capsule, along with evidence of required of manufacturing facility.
 In case the applied formulation is hard gelatin capsule, submit stability studies as per decision of
250th meeting of Registration Board according to guidelines of approve din 293 rd meeting of
Registration Board.
 Clarification shall be submitted whether applied formulation is hard gelatin capsule or soft
gelatin capsule, along with evidence of required of manufacturing facility.
 In case the applied formulation is hard gelatin capsule, submit stability studies as per
decision of 250th meeting of Registration Board according to guidelines of approve din 293rd
Brand Name + Dosage Form + Isotran 20mg Capsule
Strength
Isotretinoin…20mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s; As per SRO
2. Approved in US-FDA
Me-too status (with strength and Acnewin Capsule 20mg of Wnsfield Pharmaceuticals (Reg.#
GMP status --
 Clarification shall be submitted whether applied formulation is hard gelatin capsule or soft gelatin
capsule, along with evidence of required of manufacturing facility.
 In case the applied formulation is hard gelatin capsule, submit stability studies as per decision of
250th meeting of Registration Board according to guidelines of approve din 293 rd meeting of
Registration Board.
Brand Name + Dosage Form + Mesal 800mg Tablet
Strength
Composition Each Modified Release Tablet Contains:
Mesalazine…800mg
Type of Form Form-5
3. Asacol tablets approved by MHRA of UK
Glepib MR tablets of Martin Dow
dosage form)
GMP status --
Decision: Approved. Firm shall submit latest GMP inspection report conducted within last three
years.
Brand Name + Dosage Form + Mesal 400mg Tablet
Strength
Composition Each Modified Release Tablet Contains:
Mesalazine…400mg
Type of Form Form-5
4. Asacol tablets approved by MHRA of UK
Glepib MR tablets of Martin Dow
dosage form)
GMP status --
Brand Name + Dosage Form + Patdol 325/37.5mg Tablet
Strength
Paracetamol…325mg
Tramadol HCl…37.5mg
Pharmacological Group Analgesic/Antipyretic
Type of Form Form 5
Me-too status (with strength and Distalgesic Tablet by M/s Atco Lab. Karachi. (Reg#073865)
dosage form)
GMP status --
Brand Name + Dosage Form + Seraline 100mg Tbalet
Strength
Sertraline As HCl…….100mg
Pharmacological Group SSRI
Type of Form Form-5
Me-too status (with strength and Yesme Tablet by M/s Metro Pharmaceuticals, Islamabad.
dosage form)
GMP status --
 Submit revised composition for film coated tablet as per innovator product, along with master
formulation and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May,
2021.
Decision: Approved. Firm shall submit revised composition for film coated tablet as per innovator
product, along with master formulation and relevant fee as per Notification No. F.7-11/2012-
B&A/DRAP dated 07th May, 2021 as well as latest GMP inspection report conducted within last
Brand Name + Dosage Form + Seraline 50mg Tbalet
Strength
Sertraline As HCl…….50mg
Pharmacological Group SSRI
Type of Form Form-5
Me-too status (with strength and Yesme Tablet 50mg by M/s Metro Pharmaceuticals, Islamabad.
GMP status --
II
2021.
Decision: Approved. Firm shall submit revised composition for film coated tablet as per innovator
product, along with master formulation and relevant fee as per Notification No. F.7-11/2012-
B&A/DRAP dated 07th May, 2021 as well as latest GMP inspection report conducted within last
Brand Name + Dosage Form + Metosit Tablet 50/500mg
Strength
Pharmacological Group Anti diabetic
Type of Form Form-5
Approval status of product in Approved by EMA
Me-too status (with strength and Treviamet Tablet of M/s Getz Pharma Karachi.
dosage form)
GMP status --
Decision: Approved with Innovator’s specifications. The firm shall submit f latest GMP inspection
report conducted within last three years before issuance of registration letter.
Brand Name + Dosage Form + Metosit Tablet 50/1000mg
Strength
Type of Form Form-5
Me-too status (with strength and Treviamet Tablet of M/s Getz Pharma Karachi.
dosage form)
GMP status --
Decision: Approved with Innovator’s specifications. The firm shall submit f latest GMP inspection
report conducted within last three years before issuance of registration letter.
Brand Name + Dosage Form + Artist 80mg Tablet
Strength
Telmisartan…….80mg
Type of Form Form-5
Approval status of product in MICARDIS tablets USFDA Approved
Me-too status (with strength and Telmi tablets by M/s Crystolite Pharmaceuticals
dosage form)
GMP status --
Decision: Approved. The firm shall submit latest GMP inspection report conducted within last three
Brand Name + Dosage Form + Artist 40mg Tablet
Strength
Telmisartan…….40mg
Type of Form Form-5
Approval status of product in MICARDIS tablets USFDA Approved
Me-too status (with strength and Telmi tablets by M/s Crystolite Pharmaceuticals
dosage form)
GMP status --
Decision: Approved. The firm shall submit latest GMP inspection report conducted within last three
1189. Name and address of M/s Aries Pharmaceuticals. 1-W, Industrial Estate,
manufacturer / Applicant Hayatabad, Peshawar, k.p.k
Brand Name + Dosage Form + Prloid Table 5mg
Strength
Procyclidine Hcl…5mg
Pharmacological Group Anticholinergic
Type of Form Form-5
Me-too status (with strength and Proclidine Tablets of M/s Shaheen Pharmaceuticals,
dosage form) 3Km Murghzar Road Saidu Sharif, Swat. (Reg.# 041018)
GMP status cGMP certificate on the basis of Evaluation conducted on 06-04-
2022
Decision: Approved.
Brand Name + Dosage Form + Prox CR Tablet
Strength
Composition Each Enteric Film Coated Controlled Release Tablet Contains:
Paroxetine HCl….…25mg
Type of Form Form-5
Approval status of product in Approved in USFDA
Me-too status (with strength and Deroxat CR tablet by Global Pharma
dosage form)
2022
Decision: Approved. Firm shall submit revised label claim as per innovator product declaring the
label claim in terms of Paroxetine base along with fee of Rs. 30,000/- for correction/pre-approval
change in label claim as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form + Estra Plus Tablet 2/2mg
Strength
Composition Each Blister Pack Contains:
11 White Tablet Contains:
Estradiol Valerate…2mg
11 Brown Tablet Contains:
Estradiol Valerate…2mg
Cyproterone…1mg
Pharmacological Group Anti-androgen/estrogen
Type of Form Form-5
Approval status of product in Climen by Bayer Schering Pharma AG Germany
Me-too status (with strength and Climen by Bayer Health Care (Reg. No. 018207)
dosage form)
2022
Submit evidence of approval of required manufacturing facility of Tablet (steroidal hormone) section form
Central Licensing Board.
Submit evidence of availability of “co-blistering facility”.
Decision: Deferred for review of formulation for requirement of “co-blistering” of two different
tablets as per innovator product.
manufacturer / Applicant Hayatabad, Peshawar, K.P.K
Brand Name + Dosage Form + Cefodox 100mg/5ml
Strength
Composition Each 5ml Reconstituted Suspension Contains:
Cefpodoxime Proxetil…100mg
Pharmacological Group Anti biotic
Type of Form Form-5
Me-too status (with strength and Verpodoxine Dry Suspension by M/s Florence farma, Reg. No.
dosage form) 49247
2022
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status) alongwith
me-too status) alongwith registration number, brand name and name of firm.
Brand Name + Dosage Form + Co Besart Tablet 300/25mg
Strength
Irbesartan …300mg
Hydrochlorothiazide….…25mg
Pharmacological Group Anti-androgen/estrogen
Type of Form Form-5
Me-too status (with strength and Irbest Plus Tablets of M/s. Highnoon Laboratories
dosage form)
2022
II
Decision: Approved.
Brand Name + Dosage Form + Amlov Hct Tablet 10/160/12.5mg
Strength
Amlodipine…….10mg
Valsartan……160mg
Type of Form Form-5
Me-too status (with strength and Sofvasc –HCT Tablet of Wilson’s Pharmaceuticals, 387-388, I-9,
dosage form) Sector, Industrial Area, Islamabad. (Reg.# 077749)
GMP status GMP inspection dated 26-09-2019, the compliance level is rated
as satisfactory.
 Submit revised label claim as per innovator product declaring the salt form of Amlodipine and dosage
form as film coated tablet along with master formulation and relevant fee as per Notification No. F.7-
11/2012-B&A/DRAP dated 07th May, 2021.
 Submit latest GMP inspection report conducted within last three years.
Decision: Registration Board deferred the case for following:
 Submission of reply to the above cited shortcomings within six months.
 Verification of validity status of DML from Licensing Division.
Brand Name + Dosage Form + Amlov HCT Tablet 10/160/25mg
Strength
Type of Form Form-5
Me-too status (with strength and Sofvasc –HCT Tablet of Wilson’s Pharmaceuticals
dosage form)
as satisfactory.
Brand Name + Dosage Form + Amlov HCt Tablet 5/160/12.5mg
Strength
Type of Form Form-5
dosage form)
as satisfactory.
Brand Name + Dosage Form + Amlov HCt Tablet 5/160/25mg
Strength
Type of Form Form-5
dosage form)
as satisfactory.
II
1198. Name and address of M/s High-Q Pharmaceuticals B-64, KDA, Scheme No. 1, Main
manufacturer / Applicant Karsaz Road, Karachi, Pakistan
Brand Name + Dosage Form + FXN Tablet 180mg
Strength
Fexofenadine HCl…..…180mg
Type of Form Form-5
Me-too status (with strength and Fexokure Tablets 180mg. of M/s English Pharm (Reg.# 052411)
dosage form)
GMP status GMP inspection dated 10-8-2022, concluding good level of
compliance.
II
 Submit reference for drug product specifications.
Brand Name + Dosage Form + Orphesic Forte 650/50mg
Strength
Paracetamol….…650mg
Orphenadrine Citrate…….50mg
Pharmacological Group Narcotic analgesic combination
Type of Form Form-5
Approval status of product in N/A
Me-too status (with strength and Orthoflex-D 50mg Tablet of M/s Noa Hemis Karachi (Reg.#
compliance.
Brand Name + Dosage Form + Vortox 20mg Tablet
Strength
Vortioxetine as Hydrobromide…..…20mg
Pharmacological Group Antidepressant
Type of Form Form-5
Me-too status (with strength and Brintellix Tablets, M/s Lundbeck Pakistan (Pvt) Ltd., 40 T/4,
dosage form) Blessing Street, Block6, P.E.C.H.S, Karachi, Karachi
compliance.
II
Decision: Deferred for submission of stability studies data as per checklist of 293rd meeting of DRB,
in light of the notification No. 320-DRB/ 2022(PE&R) dated 17th October 2022.
Brand Name + Dosage Form + Vortox 10mg Tablet
Strength
Vortioxetine as Hydrobromide…..…10mg
Type of Form Form-5
Me-too status (with strength and Brintellix Tablets, M/s Lundbeck Pakistan (Pvt) Ltd., 40 T/4,
dosage form) Blessing Street, Block6, P.E.C.H.S, Karachi, Karachi
compliance.
Decision: Deferred for submission of stability studies data as per checklist of 293rd meeting of DRB,
in light of the notification No. 320-DRB/ 2022(PE&R) dated 17th October 2022.
Brand Name + Dosage Form + Atasart 10mg Tablet
Strength
Baclofen….…10mg
Pharmacological Group Skeletal muscle relaxant
Type of Form Form 5
Me-too status (with strength and Beclotab Tablets by M/s Werrick Pharmaceuticals. (Reg#026758)
dosage form)
compliance.
Decision: Approved.
Brand Name + Dosage Form + Ancotin 20mg Capsule
Strength
Isotretinoin…….20mg
Type of Form Form 5
Approval status of product in Approved by US FDA
Me-too status (with strength and Oratane capsule by M/s Crysolite
dosage form)
compliance.
 Clarification shall be submitted for applied dosage form whether hard Gelatin capsule or soft Gelatin
capsule.
Brand Name + Dosage Form + Oxytrol 3mg Tbalet
Strength
Oxybutynin HCl…..…3mg
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form 5
Me-too status (with strength and Bunin tablets of M/s Libra Pharmaceuticals (Reg.# 030317)
dosage form)
compliance.
 Reference for drug product specifications.
Brand Name + Dosage Form + Maxate 10mg Tablet
Strength
Methotrexate…..…10mg
Pharmacological Group Immunosuppressant
Type of Form Form 5
Me-too status (with strength and Methotrexate tablet 10mg of M/s Pak China International
dosage form) (Reg# 066009)
compliance.
 Evidence of approval of required manufacturing facility of “Cytotoxic/Oncology Tablet section”,
from Central Licensing Board, since the applied formulation falls in both L01 and L04 categories
as per WHO ATC classification.
 Evidence of approval of applied formulation as “film coated tablet” in reference regulatory
authorities/agencies which were declared/approved by the Registration Board.
manufacturing facility of “Cytotoxic/Oncology Tablet section”.
Brand Name + Dosage Form + Maxate 2.5mg Tablet
Strength
Methotrexate…..…2.5mg
Pharmacological Group Immunosuppressant
Type of Form Form 5
Me-too status (with strength and Methotrexate 2.5mg by PAK CHINA INTERNATIONAL
dosage form) (Reg #066007)
compliance.
 Evidence of approval of required manufacturing facility of “Cytotoxic/Oncology Tablet section”,
from Central Licensing Board, since the applied formulation falls in both L01 and L04 categories
as per WHO ATC classification.
 Evidence of approval of applied formulation as “film coated tablet” in reference regulatory
authorities/agencies which were declared/approved by the Registration Board.
manufacturing facility of “Cytotoxic/Oncology Tablet section”.
Brand Name + Dosage Form + Motrin 200mg Tablet
Strength
Ibuprofen…….200mg
Type of Form Form-5
Me-too status (with strength and Suprofen Tablet 200mg of M/s Kohs Hyderabad (Reg.# 070618)
dosage form)
compliance.
Brand Name + Dosage Form + Motrin 400mg Tablet
Strength
Ibuprofen…….400mg
Type of Form Form-5
Me-too status (with strength and Suprofen Tablet 400mg of M/s Kohs Hyderabad (Reg.# 070619)
dosage form)
compliance.
Brand Name + Dosage Form + Spasfree 5mg Tablet
Strength
Pharmacological Group Antispasmodic
Type of Form Form-5
dosage form)
compliance.
II
Brand Name + Dosage Form + Ursolox 250mg suspension
Strength
Ursodeoxycholic Acid…..…250mg
Pharmacological Group Anticholelithic
Type of Form Form-5
Me-too status (with strength and Ursodol suspension of M/s OBS Pharma (Reg.# 085632)
dosage form)
compliance.
 Reference for drug product specifications shall be submitted.
Brand Name + Dosage Form + Ursolox 250mg capsule
Strength
Ursodeoxycholic Acid…250mg
Type of Form Form-5
Approval status of product in Approved by TGA of Australia
Me-too status (with strength and Rivsa 250mg capsule of M/s martin Dow (Reg.# 082263)
dosage form)
compliance.
Brand Name + Dosage Form + Ursolox 500mg capsule
Strength
Ursodeoxycholic Acid…..500mg
Type of Form Form-5
Approval status of product in Approved by TGA of Australia
Me-too status (with strength and Rivsa 500mg capsule of M/s martin Dow (Reg.# 082264)
dosage form)
compliance.
II
Brand Name + Dosage Form + Prometa 10mg Tablet
Strength
Metoclopramide HCl ……… 10mg
Type of Form Form-5
Me-too status (with strength and Faclomide 10mg Tablets of M/s Farm Aid Group
dosage form)
compliance.
 Submit revised label claim as per innovator product along with master formulation and relevant
Decision: Approved. Firm shall submit revised label claim as per innovator product, declaring the
applied strength in terms of Metoclopramide base, along with master formulation and relevant fee
as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021 before issuance of registration
letter.
Brand Name + Dosage Form + Prometa 1mg Drops
Strength
Metoclopramide HCl….…1mg
Type of Form Form-5
Approval status of product in Not available in drops presentation
Me-too status (with strength and Not available in drops presentation
dosage form)
compliance.
II
Decision: Registration Board rejected the registration application since applied formulation is not
approved by any reference reg ulatory authority in dosage form of “Drops”, also the firm has
applied separate application of same formulation in syrup dosage form.
Brand Name + Dosage Form + Spasfree plus 10/500mg Tablet
Strength
Paracetamol…500mg
Type of Form Form-5
Approval status of product in Buscopan Plus tablet approved by BFARM of Germany
Me-too status (with strength and Spasmed Plus Tablets of M/s Genome (Reg.#068384)
dosage form)
compliance.
Brand Name + Dosage Form + Spasfree 5mg/5ml Syrup
Strength
Hyoscine Butylbromide…….5mg
Type of Form Form-5
Me-too status (with strength and Spacure Syrup of m/s Safe Pharmaceuticals (Reg.# 070564)
dosage form)
compliance.
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting.
Brand Name + Dosage Form + Prometa 5MG/5ML Syrup
Strength
Metoclopramide HCl…5mg
Type of Form Form-5
Me-too status (with strength and Mexoram syrup of M/s Meditech pharmaceuticals.
compliance.
monohydrate form of Metoclopramide hydrochloride and quantity of active ingredient in terms of
the equivalent amount of anhydrous metoclopramide hydrochloride with fee of Rs. 30,000/- for
correction/pre-approval change in composition as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021.
Brand Name + Dosage Form + Densium 2g Sachet
Strength
Strontium Ranelate ….… 2gm
Pharmacological Group Anti-osteoporosis
Type of Form Form-5
Approval status of product in Strontium ranelate Aristo 2 g granules for oral suspension by M/s
Reference Regulatory Authorities Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin
Germany, MHRA Approved.
Me-too status (with strength and ONITA SACHET by M/s PHARM-EVO (PVT) LTD, (Reg. No.
compliance.
Brand Name + Dosage Form + Oxytrol 5mg Tbalet
Strength
Oxybutynin HCl…..…5mg
Pharmacological Group Drugs for urinary frequency and incontinence
Type of Form Form 5
Me-too status (with strength and Bunin 3mg tablets of M/s Libra Pharmaceuticals
dosage form)
compliance.
 Reference for drug product specifications.
Brand Name + Dosage Form + Motrin suspension 100mg/5ml
Strength
Ibuprofen…400mg
Pharmacological Group Anti-Pyretic, Analgesic & Anti-Inflammatory
Type of Form Form-5
Me-too status (with strength and Brufen suspension of M/s Abbott
dosage form)
compliance.
Brand Name + Dosage Form + Motrin DS suspension 200mg/5ml
Strength
Ibuprofen…200mg
Pharmacological Group Anti-Pyretic, Analgesic & Anti-Inflammatory
Type of Form Form-5
Me-too status (with strength and Brufen suspension of M/s Abbott
dosage form)
compliance.
Brand Name + Dosage Form + Serazone 1gm IM/IV Injection
Strength
Composition Each Vial Contains:
Cefoperazone Sodium Eq. To Cefoperazone…500mg
Sulbactam Sodium Eq. To Sulbactam…500mg
Type of Form Form-5
Finished product Specifications JP
Approval status of product in Approved by PMDA-Japan
Me-too status (with strength and 2Sum Injection 1g of M/s Sami Pharmaceuticals, Karachi (Reg.#
renewal of DML.
II
Decision: Approved.
Brand Name + Dosage Form + Claricum 500mg Tablet
Strength
Clarithromycin…500mg
Type of Form Form 5
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status (with strength and Klarinor 500 mg Tablets by M/s Nortech Pharmaceuticals (Pvt)
dosage form) Ltd (Reg#077970)
renewal of DML.
Decision: Approved.
Brand Name + Dosage Form + MB Mox 250mg/5ml Dry Suspension
Strength
Amoxicillin Trihydrate Eq. To Amoxicillin…250mg
Type of Form Form 5
Me-too status (with strength and Oximox suspension by CSH
dosage form)
renewal of DML.
Decision: Approved.
Brand Name + Dosage Form + Kerolac 30mg/ml Injection
Strength
Ketorolac Tromethamine……30mg
Type of Form Form-5
Approval status of product in US-FDA Approved.
Me-too status (with strength and Tromit Injection of Standpharm (Reg.# 049960)
dosage form)
renewal of DML.
 Firm has not mentioned terminal sterilization step in the manufacturing process.
 Firm has submitted revised specifications as USP without submission of fee.
Decision: Deferred for clarification regarding method of sterilisation proposed for applied
formulation along with fee of Rs. 7500/- for correction/pre-approval change in product specifications
Brand Name + Dosage Form + Loratec 5mg Tablet
Strength
Desloratadine……..5mg
Type of Form Form-5
Me-too status (with strength and Desdine 5mg Tablet of M/s M/s Hygeia Pharmaceuticals,
dosage form) Islamabad (Reg.# 080821)
renewal of DML.
 Firm has submitted revised specifications as USP without submission of fee.
Decision: Approved. The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in
product specifications as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
Brand Name + Dosage Form + Phenilate 10mg Tablet
Strength
Methyl Phenidate as HCl…10mg
Pharmacological Group Centrally Acting Sympathomimetics
Type of Form Form-5
Finished product Specifications Manufacturer’s Specification
Me-too status (with strength and Phenilin tablets of M/s Dosaco Laboratories, Lahore
dosage form) Reg.no.024297
compliance.
II
 Firm has submitted revised label claim as under without submission of fee:
Methyl Phenidate HCl…10mg
Methyl Phenidate HCl …… 10mg”
Firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in product composition as
Brand Name + Dosage Form + MB Mox 125mg/5ml Dry Suspension
Strength
Amoxicillin Trihydrate Eq. To Amoxicillin…125mg
Type of Form Form 5
Me-too status (with strength and Oximox suspension by CSH
dosage form)
renewal of DML.
Decision: Approved.
Brand Name + Dosage Form + Moxilin 400mg Tablet
Strength
Moxifloxacin HCl As Moxifloxacin…..…400mg
Type of Form Form-5
Me-too status (with strength and Metoxim 400mg Tablet by M/s Foray Pharmaceutical
dosage form)
renewal of DML.
Decision: Approved.
Brand Name + Dosage Form + Diclotim 75mg Tablet
Strength
Diclofenac Potassium……75mg
Type of Form Form-5
Me-too status (with strength and Beflam 75mg Tablet by M/s Batala Pharmaceuticals Reg.#031128
dosage form)
renewal of DML.
Evidence of approval of applied formulation in reference regulatory authorities/agencies which were
declared/approved by the Registration Board.
Decision: In order to dispose of new applications of Diclofenac Potassium 75mg tablet, the Board
requested Pharmacy Services Divison to intimate PE&R Division regarding provision of safety and
efficacy studies approved bv any credible sources and shared by manufcaturers and if no such
studies are available than PMA will conduct safety and efficacy trials as per Bio study rules, 2017,
as decided by Appellate Board in 162nd meeting.
Brand Name + Dosage Form + Ritant 40mg Capsule
Strength
Aprepitant……..40mg
Pharmacological Group Anti-emetic agent
Type of Form Form-5

Me-too status (with strength and Piptant 40mg capsule by M/s Batala Pharmaceuticals Reg.#031128
dosage form)
renewal of DML.
Decision: Approved.
Brand Name + Dosage Form + Reon 250mg
Strength
Terbinafine HCl As Terbinafine………250mg
Type of Form Form-5
Me-too status (with strength and Neoterbin Tablets 250mg by M/s Neomedix Pharmaceuticals,
dosage form) Islamabad. (Reg.# 081411)
renewal of DML.
Submit reference for drug product specifications.
Firm has submitted revised specifications as USP without submission of fee.
Brand Name + Dosage Form + Zerox 8mg Tablet
Strength
Lornoxicam….…8mg
Pharmacological Group Anti-inflammatory and Antirheumatic Products
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications
Reference Regulatory Authorities approved.
Me-too status (with strength and Acabel Tablets 8mg, S.J & G Fazul Ellahie, Reg. No. 061604.
dosage form)
renewal of DML.
1234. Name
- and address of M/s MBL Pharma. B-77-A, H.I.T.E, Hub, Pakistan
Brand Name + Dosage Form + Razepate 5mg Capsule
Strength
Clorazepate Dipotassium…..…5mg
Type of Form Form-5
dosage form)
renewal of DML.
were declared/approved by the Registration Board in its 275th meeting.
1235. Name
Brand Name + Dosage Form + Asartin 50mg Tablet
Strength
Losartan Potassium….…50mg
Type of Form Form-5
Approval status of product in COZAAR® (losartan potassium) tablets Approved by USFDA
Reference Regulatory Authorities with box warning.
Me-too status (with strength and Losanta 50mg Tablet M/s Asian Continental (Pvt.) Ltd Karachi
dosage form) 057848
renewal of DML.
2021.
 Firm has submitted revised composition for film coated tablet without submission of fee.
Losartan Potassium ….… 50mg”
The firm shall submit fee of Rs. 7500/- for correction/pre-approval change in product dosage form
to film coated tablet as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before
issuance registration letter.
1236. Name
Brand Name + Dosage Form + MB Kanz 250mg/5ml Dry Suspension
Strength
Ciprofloxacin As HCl …… 250mg
Type of Form Form-5
Approval status of product in USFDA approved
Me-too status (with strength and Quash 250mg/5ml suspension of M/s Wilshire Laboratories Pvt.
dosage form) Ltd.
renewal of DML.
 Submit details for source of drug substance pellets alongwith, COA, GMP certificate and stability
studies.
 Details of the accompanying diluent for reconstitution shall be submitted along with the
manufacturing area in which it will be produced.
 Firm has submitted documents of source of pellets of Ciprofloxacin Taste masked pellets from
M/s Vision Pharma.
“Each 5ml of reconstituted suspension Contains:
Ciprofloxacin …… 250mg”
 Firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in salt form of drug
substance, as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before issuance
1237. Name
Brand Name + Dosage Form + Cefadol 500mg Capsule
Strength
Cefadroxil……500mg
Type of Form Form-5
Me-too status (with strength and Caredrox Capsule 500mg by M/s Bryon Pharmaceuticals
renewal of DML.
“Each Capsule Contains:
Cefadroxil as monohydrate……500mg”
1238. Name
Brand Name + Dosage Form + C.Ferol 5mg IM Oral Injection
Strength
Cholecalciferol….…5mg
Pharmacological Group Vitamin D3 analogue
Type of Form Form-5
Me-too status (with strength and D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
dosage form)
renewal of DML.
Decision: Approved with innovator’s specification. The firm shall submit fee of Rs. 7500/- for
1239. Name
Brand Name + Dosage Form + Claricum 250mg Tablet
Strength
Type of Form Form 5
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status (with strength and Klarinor Tablets by M/s Nortech Pharmaceuticals (Pvt) Ltd
dosage form)
renewal of DML.
Decision: Approved.
1240. Name
Brand Name + Dosage Form + Paratram Tablets
Strength
Tramadol HCl …..… 37.5mg
Paracetamol…….325mg
Pharmacological Group Analgesic/Opioid analogue
Type of Form Form-5
Ultracet by Janssen (USFDA)
Me-too status (with strength and Distalgesic Tablets by Atco laboratories, Karachi (R. No.
compliance.
 Submit revised label claim as per innovator product declaring the dosage form as film coated tablet
 Frim has submitted revised composition for film coated tablet without submission of fee.
Tramadol HCl ….… 37.5mg
Paracetamol ……. 325mg
 Firm shall submit fee of Rs. 7,500/- for correction/pre-approval change in the dosage form
as film coated tablet as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021
before issuance of registration letter.
1241. Name
Brand Name + Dosage Form + Panticol Tablet
Strength
Composition "Each Tablet Contains:
Paracetamol…….500mg
Chlorpheniramine…….4mg
Pseudoephedrine HCl……..60mg"
Pharmacological Group Analgesic/Antihistamine
Type of Form Form-5
--
Panadol CF Tablet by GSK (Reg.# 013113)
dosage form)
compliance.
II
were adopted by the Registration Board in its 275th meeting.
1242. Name
Brand Name + Dosage Form + Dozin 40mg/5ml Dry Suspension
Strength
Cefpodoxime Proxetil….…40mg
Pharmacological Group Third generation Cephalosporin
Type of Form Form-5
Approval status of product in Cefpodoxime 40mg/5ml granules for oral suspension by
Reference Regulatory Authorities Milpharm Limited (MHRA)
Xipodox 40mg /5ml by M/s. Vega Pharmaceuticals, Lahore
dosage form)
compliance.
Cefpodoxime as Proxetil….…40mg”

Cefpodoxime as Proxetil….…40mg”
 Firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in the composition
as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021 before issuance of
1243. Name
Brand Name + Dosage Form + Razepate 10mg Capsule
Strength
Clorazepate Dipotassium…..…10mg
Type of Form Form-5
dosage form)
renewal of DML.

1244. Name
Brand Name + Dosage Form + Evon 30mg Tablet
Strength
Ephedrine HCl…..…30mg
Pharmacological Group Sympathomimetic agent
Type of Form Form-5
Me-too status (with strength and Bexelex 30mg tablet of M/s Berlex Lab (Reg.# 065979)
dosage form)
renewal of DML.
 Firm has submitted revised specifications as BP, without submission of fee.
Decision: Approved with BP specification. The firm shall submit fee of Rs. 7500/- for correction/pre-
approval change in product specifications and pharmacological group as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021 before issuance of registration letter.
1245. Name
Brand Name + Dosage Form + Cinamin 500mcg IM /IV Injection
Strength
Cyanocobalamin….…500mcg
Pharmacological Group Vitamin b12
Type of Form Form-5
dosage form)
renewal of DML.
1246. Name
Brand Name + Dosage Form + Omodine 50mg IM/IV Injection
Strength
Ranitidine HCl Eq. To Ranitidine…50mg
Pharmacological Group H2-receptor antagonists
Type of Form Form 5
Me-too status (with strength and Peplov Injection 50mg by M/s. Pulse Pharmaceuticals,
renewal of DML.
 The applied formulation has been suspended by US FDA.
1247. Name
Brand Name + Dosage Form + Viospan 200mg/5ml Dry Suspension
Strength
Cefixime As Trihydrate…200mg
Pharmacological Group Cephalosporin
Type of Form Form 5
Approval status of product in SUPRAX 200mg/5ml Dry Powder Suspension USFDA Approved.
Me-too status (with strength and Rofixime DS Suspension by SPL Pharmaceuticals (Pvt)
dosage form) Ltd, (Reg#45506)
renewal of DML.
Decision: Approved.
1248. Name
Brand Name + Dosage Form + Pritim 150mg Tablet
Strength
Itopride Hcl…150mg
Pharmacological Group Prokinetic
Type of Form Form-5
Me-too status (with strength and Itoride SR Tablets of Amarant Karachi (Reg # 073484)
dosage form)
renewal of DML.
authorities/agencies which were declared/approved by the Registration Board in its 275th meeting.
1249. Name
Brand Name + Dosage Form + Silbet 50/500 mg Tablet
Strength
Sitagliptin Phosphate…50mg
Pharmacological Group Anti-diabetic agent and oral hypoglycemic
Type of Form Form-5
Finished product Specifications Manufacturer specification
Me-too status (with strength and Sitamet tablet by M/s CCL Pharmaceuticals Pvt. Ltd.
dosage form)
renewal of DML.
 Submit revised label claim as per innovator product declaring the label claim for Sitagliptin
phosphate monohydrate in terms of Sitagliptin base, along with master formulation and relevant
Sitagliptin as Phosphate monohydrate …50mg
Metformin HCl….…500mg”
Sitagliptin as Phosphate monohydrate …50mg
Metformin HCl….…500mg”
 The firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in salt form of
drug substance as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before
1250. Name
Brand Name + Dosage Form + Loratec 0.5mg/ml Syrup
Strength
Composition "Each ml Contains:
Desloratadine…..…0.5mg"
Type of Form Form-5
Approval status of product in Aerius For Children Syrup desloratadine 2.5mg/5mL oral liquid
Reference Regulatory Authorities bottle by M/s Bayer Australia Ltd (TGA approved)
Me-too status (with strength and Desora 0.5mg/ml syrup by M/s Continental Pharma. (Reg.#
renewal of DML.
1251. Name
Brand Name + Dosage Form + MB Kanz 125mg/5ml Dry Suspension
Strength
Ciprofloxacin As HCl…125mg
Type of Form Form-5
Approval status of product in Approved by Registration Board on the recommended dosage
Reference Regulatory Authorities basis
dosage form) Ltd.
renewal of DML.
 Submit details for source of drug substance pellets along with, COA, GMP certificate and stability
studies.
 Details of the accompanying diluent for reconstitution shall be submitted along with the
manufacturing area in which it will be produced.
 Firm has submitted source of pellets from M/s Vision Pharma.
Decision: Approved as per following label claim and diluent as per innovator drug product:
“Each 5ml of reconstituted suspension Contains:
Ciprofloxacin …… 125mg”
1252. Name
Brand Name + Dosage Form + Metanium 15mg Capsule
Strength
Temazepam……15mg
Type of Form Form-5
Me-too status (with strength and Calm 15mg capsule of M/s Wilshire laboratories
dosage form)
compliance.
 Evidence of approval of required manufacturing facility “Capsule (Psychotropic)” from CLB shall
be submitted.
Decision: Registration Board rejected the application since firm does not have approval for
required manufacturing facility / section i.e., “Capsule (Psychotropic) section” from CLB.
1253. Name
Brand Name + Dosage Form + Metanium 30mg Capsule
Strength
Temazepam……30mg
Type of Form Form-5
Me-too status (with strength and Calm 30mg capsule of M/s Wilshire laboratories
dosage form)
compliance.
 Evidence of approval of required manufacturing facility “Capsule (Psychoptropic)” from CLB
shall be submitted.
Decision: Registration Board rejected the application since firm does not have approval for
required manufacturing facility / section i.e., “Capsule (Psychotropic) section” from CLB.
1254. Name
Brand Name + Dosage Form + Claricum 125mg/5ml Dry Suspension
Strength
Type of Form Form 5
Approval status of product in Biaxin 125mg/5ml by M/s Abbvie, USFDA
Me-too status (with strength and Klarim Dry Suspension of M/s Amrose Pharmaceuticals, Karachi
renewal of DML.
II
Decision: Approved. Firm shall submit source of pellets along with stability studies data, GMP
certificate of supplier and differential fee in case of import of pellets before issuance of registration
letter.
1255. Name
- and address of M/s Jinnah Pharmaceuticals Pvt Ltd. 13 km, Lahore Road,
manufacturer / Applicant Multan
Brand Name + Dosage Form + Fexofan-D Tablets
Strength
Fexofenadine as HCl ……. 60mg
Pseudoephedrine as HCl …..…120mg"
Pharmacological Group Anti-Histamine & Sympathomimetic agent
Type of Form Form 5
Approval status of product in TELFAST Decongestant of Sanofi Aventis (Approved in TGA
Reference Regulatory Authorities Australia)
Me-too status (with strength and Fexet-D 60Mg/120Mg Tablets of Getz Pharma (Pvt.) Ltd,
dosage form) Karachi (Reg # 039099)
2021.
II
 Submit revised label claim as per innovator product declaring the label claim for Fexofenadine
HCl & Pseudoephedrine HCl in terms of complete salt form as well as dosage form as “Film
coated bi-layer tablet” along with master formulation and relevant fee as per Notification No. F.7-
 Submit evidence of
availability of “Bi-layer compression machine.”
Decision: Defered for evidence of availability of “Bilayer tablet compression” machine.
1256. Name
Brand Name + Dosage Form + J-Uric 80mg Tablets
Strength
Febuxostat…..…80mg
Pharmacological Group Anti-Gout
Type of Form Form 5
Me-too status (with strength and Febuxin by M/s AGP, Karachi (Reg. No. 081105)
dosage form)
2021.
 Submit revised label claim as per innovator product declaring the dosage form as “Film coated
tablet” along with master formulation and relevant fee as per Notification No. F.7-11/2012-
 Firm has submitted revised label claim for film coated tablet along with fee of Rs. 7,500/- vide
1257. Name
Brand Name + Dosage Form + Jazolid 600mg Tablet
Strength
Linezolid…600mg
Type of Form Form 5
Pack size & Demanded Price As recommended by PRC
Me-too status (with strength and Linzol tablet 600mg of M/s Regal Pharmaceuticals
dosage form)
2021.
 Submit revised label claim as per innovator product declaring dosage form as “Film coated tablet”
1258. Name
Brand Name + Dosage Form + J-Meb Plus Sachet
Strength
Mebeverine HCl……135mg
Psyllium Husk…….3.5gm
Pharmacological Group Antispasmodic & laxative
Type of Form Form-5
Me-too status (with strength and Mepasm Plus Sachet of M/s Martin Dow Ltd. Karachi (Reg.#
2021.
1259. Name
- and address of M/s Jinnah Pharmaceuticals Pvt. Ltd. 13 km, Lahore Road,
Brand Name + Dosage Form + Masqunil -Plus Capsule
Strength
Composition "Each Capsule Contains:
Dihydroartimisinin…40mg
Piperaquine Phosphate…320mg"
Pharmacological Group Antimalarials
Type of Form Form-5
Approval status of product in Dihydroartemisinin/Piperaquine (phosphate) 40mg / 320mg
Reference Regulatory Authorities film-coated tablets WHO approved formulation
Me-too status (with strength and Peproxin Tablets 40mg /320mg by M/s Wnsfield Pharmaceuticals
2021.
II
Evidence of approval of applied formulation in capsule form. in reference regulatory authorities/agencies
Firm has submitted revised composition as follows along with fee of Rs. 30,000/- vide deposit slip#
70523241
"Each film coated tablet Contains:
Dihydroartimisinin…40mg
"Each film coated tablet Contains:
Dihydroartimisinin……40mg
Piperaquine Phosphate……320mg"
1260. Name
Brand Name + Dosage Form + Jamsolin 0.4mg Capsule
Strength
Tamsulocin HCl……..0.4mg
Pharmacological Group Alpha 1 adrenergic receptor blocker
Type of Form Form 5
Me-too status (with strength and Uripro 0.4mg Capsule M/s Getz Pharma (Reg.#081040)
dosage form)
2021.
Decision: Approved. Firm shall submit source of pellets along with relevant documents. i.e., COA,
GMP certificate of supplier and stability studies data of the pellets as per Zone-Iva before issuance
1261. Name
Brand Name + Dosage Form + J-Zome 40mg Capsule
Strength
Esomeprazole….…40mg"
Pharmacological Group Proton pump inhibitors
Type of Form Form 5
Me-too status (with strength and Nexium Capsules by Getz Pharma
dosage form)
2021.
 Submit revised label claim as per innovator product declaring the salt form of Esomeprazole, along
07th May, 2021.
“Each delayed release capsule contains:
Esomeprazole as magnesium …… 40mg
(in form of enteric coated pellets)
 Firm has submitted source of pellets as Vision pharma
Decision: Approved s per following label claim:
Esomeprazole as magnesium …… 40mg
(in form of enteric coated pellets)”
1262. Name
Brand Name + Dosage Form + J-Rexin 20mg Tablets
Strength
Piroxicam As Betacyclodextrin….…20mg"
Pharmacological Group NSAIDs
Type of Form Form 5
Approval status of product in CYCLADOL 20 mg scored tablet. ANSM approved
Me-too status (with strength and Utrahit-beta Tablet. Reg. No. 81355
dosage form)
2021.
1263. Name
Brand Name + Dosage Form + J-Zole Sachet
Strength
Omeprazole….…40mg
Sodium Bicarbonate…….1680mg
Pharmacological Group Proton pump inhibitor/Antacid
Type of Form Form 5
Me-too status (with strength and Risek Insta Sachet by Getz Pharma (Pvt.) Ltd., Karachi
dosage form)
2021.
II
Decision: aPPROVED.
1264. Name
Brand Name + Dosage Form + Masqunil -Plus Sachet
Strength
Composition "Each Sachet Contains:
Dihydroartemisinin…15mg
Type of Form Form 5
Me-too status (with strength and Timequin Sachet 15/120 by M/s Sami Pharmaceuticals (Pvt) Ltd,
dosage form) Reg No. 70787
2021.
Evidence of approval of applied formulation/drug in reference regulatory authorities adopted by
Registration Board in 275th meeting or WHO approval status.
Decision: Deferred for evidence of approval of applied formulation/drug in reference regulatory
authorities adopted by Registration Board in 275th meeting or WHO approval status.
1265. Name
Brand Name + Dosage Form + J-Zole 40mg Capsule
Strength
Omeprazole…40mg
Type of Form Form 5
Me-too status (with strength and Risek Capsules by Getz Pharma
dosage form)
2021.
 Submit revised label claim as per innovator product declaring the physical form of omepraozle,
 Frim has submitted revised label claim declaring Omeprazole as enteric coated pellets along with
source of pellets from M/s Vison Pharma and fee of Rs 7500/-.
Decision: Decision: Approved s per following label claim:
Omeprazole …… 40mg
(in form of enteric coated pellets)”
1266. Name
Brand Name + Dosage Form + Malam Plus Tablets
Strength
Artemether…80mg
Lumefantrine…480mg
Type of Form Form-5
Approval status of product in WHO recommended formulation
Me-too status (with strength and Artem -DS Plus Tablets 80/480 of M/s Hilton Pharma, Karachi
2021.
Decision: Approved.
1267. Name
Brand Name + Dosage Form + J-Uric 40mg Tablets
Strength
Pharmacological Group Anti-Gout
Type of Form Form 5
Me-too status (with strength and Febuxin by M/s AGP, Karachi
dosage form)
2021.
 Submit revised label claim as per innovator product declaring dosage form as “Film coated tablet”
1268. Name
Brand Name + Dosage Form + Deweal Plus Sachet
Strength
Composition "Each Sachet Contains:
Ascorbic Acid…100mg
Nicotinamide…50mg
Riboflavin…15mg
Thiamine Hcl…15mg
Pyridoxine…10mg
Calcium…134.64mg"
Pharmacological Group Multi Vitamin
Type of Form Form 5
dosage form)
2021.
1269. Name
Brand Name + Dosage Form + Jenafin 125mg Tablet
Strength
Terbinafine As HCl ….… 125mg
Type of Form Form-5
Me-too status (with strength and Mycoderm 125mg Tablet by M/s Nabiqasim Karachi. (Reg.#
2021.
Decision: Approved.
1270. Name
Brand Name + Dosage Form + Jenafin 250mg Tablet
Strength
Terbinafine As HCl ….… 250mg
Type of Form Form-5
Me-too status (with strength and Mycoderm Tablet by M/s Nabiqasim Karachi.
dosage form)
2021.
Decision: Approved.
1271. Name
Brand Name + Dosage Form + Jeslo 5mg Tablet
Strength
Desloratadine…5mg
Type of Form Form-5
Me-too status (with strength and Desdine 5mg Tablet of M/s M/s Hygeia Pharmaceuticals,
2021.
Decision: Approved.
1272. Name
Brand Name + Dosage Form + J-Fylin 400mg Tablet
Strength
Doxofylline…400mg
Pharmacological Group Xanthines
Type of Form Form-5
Approval status of product in DOXOFILLINA ABC 400mg tablet. AIFA approved
Me-too status (with strength and Profylline Tablet 400mg. Reg. No. 73744
dosage form)
2021.
1273. Name
Brand Name + Dosage Form + Jazolid 400mg Tablet
Strength
Linezolid…….400mg
Type of Form Form-5
Approval status of product in ZYVOX® (linezolid) tablets (film-coated) for oral use by
Reference Regulatory Authorities Pharmacia and Upjohn. not discontinued or withdrawn by USFDA
for safety or efficacy reasons
Me-too status (with strength and Enliv 400mg Tablet by PharmEvo (Pvt.) Ltd. Reg No. 58096
dosage form)
2021.
Remarks of the Evaluator II: Firm has submitted revised label claim for film coated tablet along with
fee of Rs. 7,500/- vide deposit slip# 199132626967
Linezolid…….400mg
1274. Name
Brand Name + Dosage Form + Jantial 10mg Tablet
Strength
Loratadine…10mg
Pharmacological Group Anti-histamine
Type of Form Form-5
Approval status of product in Clarityn Allergy 10mg Tablets by M/s UCB Pharma, (MHRA
Reference Regulatory Authorities Approved).
Me-too status (with strength and Softin 10 mg Tablet by M/s Werrick Pharmaceuticals,
dosage form) (Reg # 012026)
2021.
Decision: Approved.
1275. Name
- and address of M/s Genix Pharma Pvt Ltd. 44,45-B, Korangi Creek Road,
manufacturer / Applicant Karachi, 75190, Pakistan
Brand Name + Dosage Form + Lozep 1mg Tablet
Strength
Lormetazepam……1mg
Pharmacological Group Hypnotics and sedatives
Type of Form Form-5
Me-too status (with strength and Lyzapam 1 mg Tablet by M/s Atco Laboratories, (Reg # 029875)
dosage form)
GMP status Last inspection was conducted on 12-02-2020 and report
concludes that based on the area inspected. The people met and the
document reviewed and considering the findings of the inspection
firm was considered to be operating at a good level of compliance
with cGMP guideline as of today.
Decision: Deferred for evidence of approval of required manufacturing facility of “Tablet
Psychotropic” section” from CLB.
1276. Name
Brand Name + Dosage Form + Galmin 4mg/ml Oral Solution
Strength
Composition "Each ml Contains:
Galantamine Hydrobromide Eq. To Galantamine…4mg"
Pharmacological Group Dy.No 13729 dated 07-03-2019 Rs.20,000/- dated 06-03-2019
Type of Form Form-5
Approval status of product in Reminyl oral solution, MHRA Approved
Me-too status (with strength and Dementio oral solution by M/s Reko, (Reg # 069433)
dosage form)
Decision: Approved.
1277. Name
Brand Name + Dosage Form + Verlin 0.5mg Tablet
Strength
Varenicline Tartrate Eq. To Varenicline…0.5mg
Pharmacological Group Other nervous system drugs
Type of Form Form-5
Me-too status (with strength and Clivin 0.5mg tablet by M/s Wilshire, (Reg # 103625)
dosage form)
1278. Name
- and address of M/s Cunningham Pharmaceuticals Pvt Ltd. Plot # 81, Sunder
Brand Name + Dosage Form + Ovipreg 50mg Tablet
Strength
Clomiphene Citrate…50mg
Pharmacological Group Ovulation stimulants, synthetic
Type of Form Form-5
Pack size & Demanded Price As recommended by the PRC
Me-too status (with strength and Gynofen 50mg Tablet. Reg No. 53337
dosage form)
GMP status The firm is granted GMP certificate based on inspection conducted
on 01-04-2019.
Capacity assessment inspection of M/s Cunningham
Pharmaceuticals Lahore was carried out on 12-11-2020 and the
report was presented in 297th meeting of Registration Board.
II
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.
Firm shall submit latest GMP inspection report conducted within last three years, before issuance
1279. Name
Brand Name + Dosage Form + C Praz Capsule 20mg
Strength
Composition Each Capsule Contains
Omeprazole as enteric Coated Pellets …20mg
Type of Form Form 5
dosage form)
on 01-04-2019.
Source of pellets is from M/s Vision pharmaceuticals.
Decision: Approved.
1280. Name
Brand Name + Dosage Form + Candasia 500mg Tablet
Strength
Composition Each vaginal tablet Contains:
Clotrimazole…….500mg
Type of Form Form 5
Finished product Specifications BP Specification
Me-too status (with strength and Gynotec 500mg Tablet of M/s. Noa Haemis Pharmaceuticals,
dosage form) Karachi (Reg.no. 032208)
on 01-04-2019.

Decision: Approved.
1281. Name
Brand Name + Dosage Form + Irbest 300mg Tablet
Strength
Composition "Each Film Coated Tablet Contains:
Irbesartan ….… 300mg”
Pharmacological Group Angiotensi II receptor blocker
Type of Form Form-5
Me-too status (with strength and Arbi 300mg Tablet of M/s Pharmevo Karachi (Reg.# 073770)
dosage form)
on 01-04-2019.
Decision: Approved.
1282. Name
Strength
Irbesartan ……75mg
Pharmacological Group Angiotensi II receptor blocker
Type of Form Form-5
Me-too status (with strength and Irecon Tablet of M/s Barret (Reg.# 039725)
dosage form)
on 01-04-2019.
Decision: Approved.
1283. Name
Brand Name + Dosage Form + Cubiprofen 300mg Tablet
Strength
Pharmacological Group Propionic acid derivatives
Type of Form Form-5
Approval status of product in Dexibuprofen 300 mg film-coated tablets MHRA Approved
Me-too status (with strength and Tercica 300mg Tablet. Reg. No. 58445
dosage form)
on 01-04-2019.
Decision: Approved.
1284. Name
Brand Name + Dosage Form + Duxet Capsule 30mg
Strength
Duloxetine as HCl (Enteric Coated Pellets)…30mg"
Type of Form Form-5
Me-too status (with strength and Dulan capsules of M/s Hilton Pharma (Pvt.) Limited Karachi
on 01-04-2019.
II
Remarks of the Evaluator : Submit source of pellets along with relevant documents. i.e., COA, GMP
certificate of supplier and stability studies data of the pellets as per Zone-Iva.
Firm has submitted documents for source of pellets form M/s Vision pharmaceuticals.
Decision: Approved.
1285. Name
Brand Name + Dosage Form + Duxet Capsule 60mg
Strength
Duloxetine as HCl (Enteric Coated Pellets)…60mg"
Type of Form Form-5
Me-too status (with strength and Dulan capsules of M/s Hilton Pharma (Pvt.) Limited Karachi
dosage form)
on 01-04-2019.
II
Remarks of the Evaluator : Submit source of pellets along with relevant documents. i.e., COA, GMP
certificate of supplier and stability studies data of the pellets as per Zone-Iva.
Decision: Approved.
1286. Name
Brand Name + Dosage Form + Bambudil 10mg Tablet
Strength
Bambuterol HCl….…10mg
Pharmacological Group Long acting beta adreno receptor agonist
Type of Form Form-5
Approval status of product in Approved in MHRA
Me-too status (with strength and Bambuzaf tablet of M/s Zafa Pharma 067573
dosage form)
on 01-04-2019.
B&A/DRAP dated 07-05-2021 alongwith latest GMP inspection report conducted within last three
years, before issuance of registration letter before issuance of registration letter.
1287. Name
Strength
Irbesartan …150mg
Pharmacological Group Angiotensin II receptor blocker
Type of Form Form-5
Me-too status (with strength and Irecon Tablet of M/s Barret (Reg.# 039726)
dosage form)
on 01-04-2019.
Decision: Approved.
1288. Name
Brand Name + Dosage Form + Cubiprofen 400mg Tablet
Strength
Pharmacological Group Propionic acid derivatives
Type of Form Form-5
Me-too status (with strength and Tercica 400mg Tablet of M/s Sami. Reg. No. 58446
dosage form)
on 01-04-2019.
Decision: Approved.
1289. Name
Brand Name + Dosage Form + C Praz Capsule 40mg
Strength
Composition Each Capsule Contains
Omeprazole as Enteric Coated Pellets ……. 40mg
Type of Form Form 5
dosage form)
on 01-04-2019.
II
Remarks of the Evaluator : Firm has submitted documents for source of pellets form M/s Vision
pharmaceuticals.
Decision: Approved.
1290. Name
Brand Name + Dosage Form + Candasia 100mg Tablet
Strength
Composition Each vaginal Tablet Contains:
Clotrimazole…….100mg
Type of Form Form 5
Finished product Specifications BP Specification
Me-too status (with strength and Gynotec 500mg Tablet of M/s. Noa Haemis Pharmaceuticals,
dosage form) Karachi (Reg.no. 032207)
on 01-04-2019.
Decision: Approved.
1291. Name
- and address of M/s Caliph Pharmaceuticals Pvt Ltd. Plot # 17, Special
manufacturer / Applicant Industrial Zone, Risalpur, KPK, Pakistan
Brand Name + Dosage Form + Hydrocal 1% Cream
Strength
Composition Each Gm Cream Contains:
Hydrocortisone Acetate…1%
Type of Form Form 5
Me-too status (with strength and Hyzol cream of M/s Danas Pharmaceuticals (Reg.no. 041039)
dosage form)
GMP status --
Latest GMP inspection report conducted within last three years shall be submitted.
years, before issuance of registration letter.
1292. Name
- and address of M/s Caliph Pharmaceuticals Pvt Ltd. Plot # 17, Special
manufacturer / Applicant Industrial Zone, Risalpur, KPK, Pakistan
Brand Name + Dosage Form + Fusical-H Cream
Strength
Composition "Each Gm Cream Contains:
Fusidic Acid…2%
Hydrocortisone Acetate…..…1%"
Pharmacological Group Antibiotic/Corticosteroid
Type of Form Form-5
Approval status of product in Fucidin H cream of M/s LEO Laboratories Limited, approved by
Reference Regulatory Authorities MHRA of UK
Me-too status (with strength and Mirazym Cream of M/s Hiranis Karachi (Reg.# 076516)
dosage form)
GMP status --
II
years, before issuance of registration letter. before issuance of registration letter.
1293. Name
- and address of M/s Danas Pharmaceuticals Pvt Ltd. 312, Industrial Triangle,
manufacturer / Applicant Kahuta Road, Islamabad
Brand Name + Dosage Form + Glovumet 50/500mg Tablet
Strength
Vildagliptin…50mg
Type of Form Form-5
dosage form)
2017.
1294. Name
Strength
Vildagliptin…….50mg
Type of Form Form-5
dosage form)
2017.
1295. Name
Strength
Vildagliptin…50mg
Type of Form Form-5
dosage form)
2017.
II
1296. Name
Brand Name + Dosage Form + Betanil 24mg
Strength
Betahistine Dihydrochloride……..24mg"
Pharmacological Group Anti-vertigo preparations
Type of Form Form-5
Me-too status (with strength and Serc 24 mg tablet (Reg.# 059823)
dosage form)
2017.
II
Firm has submitted revised specifications as BP, without submission of fee.
Decision: Approved with BP specifications. The firm shall submit fee of Rs. 7,500/- for
1297. Name
Brand Name + Dosage Form + Zolesta 10mg Tablet
Strength
Zolpidem Tartrate….…10mg
Pharmacological Group Hypnotic
Type of Form Form-5
Me-too status (with strength and Olida 10mg Tablets of M/s Glitz Pharmaceuticals, Islamabad
2017.
Firm has submitted revised specifications as USP, without submission of fee.
manufacturing facility of “Psychotropic Tablet section”.
1298. Name
Brand Name + Dosage Form + Glunor 1000mg Tablet
Strength
Type of Form Form-5
Me-too status (with strength and Glucophage tablet of M/s Martin Dow. Ltd.
dosage form)
2017.
Decision: Approved with USP specification. The firm shall submit fee of Rs. 7500/- for
1299. Name
Brand Name + Dosage Form + Nepzil 10mg Tablet
Strength
Donepezil HCl…….10mg
Pharmacological Group Cholinesterase inhibitors
Type of Form Form-5
Me-too status (with strength and Remembrin Tablets 10mg of M/s PharmEvo, Karachi (Reg.#
2017.
1300. Name
Brand Name + Dosage Form + Nepzil 5mg Tablet
Strength
Type of Form Form-5
Me-too status (with strength and Remembrin Tablets of M/s PharmEvo, Karachi
dosage form)
2017.
II
1301. Name
Strength
Betahistine Dihydrochloride……16mg"
Type of Form Form-5
Me-too status (with strength and Serc 16mg tablet of M/s Abbott
dosage form)
2017.
Decision: Approved with BP specification and change of brand name. The firm shall submit fee of
Rs. 7500/- for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021 alongwith latest GMP inspection report conducted within
last three years, before issuance of registration letter.
1302. Name
Strength
Betahistine Dihydrochloride……8mg"
Type of Form Form-5
Me-too status (with strength and Serc 8mg tablet of M/s Abbott
dosage form)
2017.
Decision: Approved with BP specification and change of brand name. The firm shall submit fee of
Rs. 7500/- for correction/pre-approval change in product specifications as per notification No.F.7-
11/2012-B&A/DRAP dated 07-05-2021 alongwith latest GMP inspection report conducted within
last three years, before issuance of registration letter.
1303. Name
Strength
Type of Form Form-5
dosage form)
2017.
1304. Name
Strength
Type of Form Form-5
dosage form)
2017.
1305. Name
Brand Name + Dosage Form + Danfol Tablet 5mg
Strength
Folic Acid……5mg
Pharmacological Group Vitamin B9
Type of Form Form-5
Me-too status (with strength and Zal 5mg tablet of M/s Alson Pharmaceuticals (Reg.#038180)
dosage form)
2017.
II
1306. Name
Brand Name + Dosage Form + Alziment 10mg Tablet
Strength
Memantine as HCl….…10mg
Pharmacological Group Psychoanaleptics.
Type of Form Form-5
Me-too status (with strength and Dmantin 10mg Tablets by M/s Genome Pharmaceuticals
2017.
1307. Name
Brand Name + Dosage Form + Gabfast Capsule 25mg
Strength
Pregabalin…….25mg
Pharmacological Group Anti epileptic
Type of Form Form-5
Me-too status (with strength and Neugalin 25mg capsule of M/s Barret Hodgson (Reg.#086001)
dosage form)
2017.
Remarks of the Evaluator II: BP monograph is available for applied formulation.
05-2021 alongwith latest GMP inspection report conducted within last three years, before issuance
1308. Name
Brand Name + Dosage Form + Istamet Tablet 50/500mg Tablet
Strength
Type of Form Form-5
Finished product Specifications Manufacturer specifcations
Me-too status (with strength and Sitamet Tablets by M/s CCL Pharmaceuticals
dosage form)
2017.
Decision: Approved with Innovator’s specification. The firm shall submit revised label claim as per
innovator product for salt form of Sitagliptin with master formulation and fee of Rs. 30,000/- for
correction/pre-approval change in product specifications and composition, as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021 alongwith latest GMP inspection report conducted
within last three years, before issuance of registration letter.
1309. Name
Brand Name + Dosage Form + Istamet Tablet 50/1000mg Tablet
Strength
Type of Form Form-5
Me-too status (with strength and Sitamet Tablets by M/s CCL Pharmaceuticals
dosage form)
2017.
Decision: Approved with Innovator’s specification. The firm shall submit revised label claim as per
innovator product for salt form of Sitagliptin with master formulation and fee of Rs. 30,000/- for
correction/pre-approval change in product specifications and composition, as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021 alongwith latest GMP inspection report conducted
within last three years, before issuance of registration letter.
1310. Name
- and address of M/s Inventor Pharma. Plot No. K/196, S.I.T.E. (SHW) Phase
manufacturer / Applicant II, Karachi
Brand Name + Dosage Form + Fencare 100mg Tablet
Strength
Aceclofenac….…100mg
Pharmacological Group Rheumatoid arthritis
Type of Form Form-5
Me-too status (with strength and Aclofen Tablets by M/s Alliance Pharmaceuticals (Pvt) Ltd,
GMP status GMP inspection conducted on 13-09-2022 concluded good GMP
compliance.
Decision: Approved with Innovator’s specification. The firm shall submit fee of Rs. 7,500/- for
correction/pre-approval change in product specifications, as per notification No.F.7-11/2012-
1311. Name
Brand Name + Dosage Form + Nimcare 100mg Tablet
Strength
Nimesulide…100mg
Pharmacological Group NSAIDS
Type of Form Form-5
Approval status of product in ALGIMESIL 100 mg tablets AIFA Italy Approved
Me-too status (with strength and Nimcid Tablets by Unexolabs (Reg#46336)
dosage form)
compliance.
Submit revised label claim as per innovator product declaring dosage form as uncoated tablet along with
master formulation and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May,
2021.
Decision: Approved with Innovator’s specifications as per following label claim:
Nimesulide ….… 100mg”
 Firm shall submit revised master formulation declaring dosage form as uncoated tablet
along fee of Rs. 7,500/- as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
1312. Name
Brand Name + Dosage Form + Diclovetor SR 100mg Tablet
Strength
Diclofenac Sodium…100mg"
Type of Form Form-5
Pack size & Demanded Price As per SRo
compliance.
Submit revised label claim as per innovator product declaring dosage form as film coated sustained release
tablet along with master formulation and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP
“Each Film Coated sustained release Tablet Contains:
Diclofenac Sodium …….100mg”
 Firm shall submit revised master formulation declaring dosage form as film coated sustained
release tablet along fee of Rs. 30,000/-/- as per Notification No. F.7-11/2012-B&A/DRAP
1313. Name
Brand Name + Dosage Form + Inospon 80/80 mg Tablet
Strength
Composition Each Sugar Coated Tablet Contains:
Phloroglucinol……80mg
Trimethylphloroglucinol……80mg
Type of Form Form-5
Approval status of product in SPASFON (ANSM approved)
Me-too status (with strength and Spasrid tablets of M/s Barret Hodgson (Reg.# 034743)
dosage form)
compliance.
Submit revised label claim as per innovator product declaring hydrated salt form of phloroglucinol along
with master formulation and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May,
2021.
Decision: Approved with innovator’s specifications. Firm shall submit revised label claim as per
innovator product declaring hydrated salt form of phloroglucinol along with master formulation
and relevant fee as per Notification No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
1314. Name
Brand Name + Dosage Form + Infast 75mg Tablet
Strength
Type of Form Form-5
Me-too status (with strength and Beflam 75mg Tablet by M/s BatalaPharmaceuticals Reg.#031128
dosage form)
compliance.
Evidence of approval of applied formulation in reference regulatory authorities/agencies which were
declared/approved by the Registration Board in its 275th meeting.
Decision: In order to dispose of new applications of Diclofenac Potassium 75mg tablet, the Board
requested Pharmacy Services Divison to intimate PE&R Division regarding provision of safety and
efficacy studies approved bv any credible sources and shared by manufcaturers and if no such
studies are available than PMA will conduct safety and efficacy trials as per Bio study rules, 2017,
as decided by Appellate Board in 162nd meeting.
1315. Name
Brand Name + Dosage Form + Devotor 2.5mg/5ml Syrup
Strength
Desloratadine ……. 2.5mg
Type of Form Form-5
Approval status of product in Aerius For Children Syrup Desloratadine 2.5mg/5mL oral liquid
Reference Regulatory Authorities bottle by M/s Bayer Australia Ltd (TGA approved)
Me-too status (with strength and Desora 0.5mg/ml syrup by M/s Continental Pharma. (Reg.#
compliance.
1316. Name
Brand Name + Dosage Form + Cefo 40mg/5ml Oral Suspension
Strength
Cefpodoxime Proxetil Eq. To Cefpodoxime…40mg
Pharmacological Group Third generation Cephalosporin
Type of Form Form-5
Approval status of product in Cefpodoxime 40mg/5ml granules for oral suspension by
Reference Regulatory Authorities Milpharm Limited (MHRA)
Xipodox 40mg /5ml by M/s. Vega Pharmaceuticals, Lahore
dosage form)
compliance.
Decision: Decision: Approved.
1317. Name
Brand Name + Dosage Form + Ferrax 100/0.35 mg Tablet
Strength
Iron Polymaltose….…100mg
Folic Acid….…0.35mg
Type of Form Form-5
--
Me-too status (with strength and Ipomalt -F Tablets of M/s Rock Pharmaceutical Laboratories
dosage form) (Pvt) Ltd. (Reg.# 077301)
GMP status --
Submit revised label claim the complete salt form of iron polymaltose and declare strength in term of the
elemental Iron, along with master formulation and relevant fee as per Notification No. F.7-11/2012-
Decision: Approved with Innovator’s specifications, as per following label claim:
Iron (III) Hydroxide Polymaltose complex eq. to elemental Iron …………... 100mg
Folic Acid ….… 0.35mg”
 The firm shall submit fee of Rs. 30,000/- for correction/pre-approval change in product
composition as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 alongwith
latest GMP inspection report conducted within last three years, before issuance of
registration letter before issuance of registration letter.
1318. Name
Brand Name + Dosage Form + Instron 8mg/4ml Injection
Strength
Ondansetron as HCl Dihydrate …..… 8mg
Pharmacological Group Anti-emetic
Type of Form Form-5
Approved by US FDA
Onset Injection of M/s Pharmedic
dosage form)
compliance.
II
1319. Name
Brand Name + Dosage Form + Amlotin 5/20 mg Tablet
Strength
Atorvastatin As Calcium……20mg
Pharmacological Group Calcium channel blocker/ HMG CoA reductase inhibitors
Type of Form Form-5
Me-too status (with strength and Caduet 5mg/20mg Tablet by M/s Pfizer Laboratories ltd., Karachi
compliance.
Submit revised label claim as per innovator product declaring the hydrate form of Atorvastatin calcium
and dosage form as film coated tablet, along with master formulation and relevant fee as per Notification
No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
Amlodipine as besylate …… 5mg
Atorvastatin as calcium trihydrate …… 20mg”
composition as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021.
1320. Name
- and address of M/s Genetics Pharmaceuticals Pvt. Ltd. 539-A, Sundar
manufacturer / Applicant Industrial Estate, Raiwind, Lahore
Brand Name + Dosage Form + Lepsi 750mg XR Tablet
Strength
Composition Each Film Coated Extended Release Tablet Contains:
Levetiracetam……..750mg
Pharmacological Group Anti epileptic
Type of Form Form-5
Me-too status (with strength and Lerace XR 750mg tablet of M/s Hilton Pharma (Reg.#107780)
dosage form)
GMP status --
Remarks of the Evaluator II: USP monograph is available for applied formulation whereas firm has
applied in-house specifications. Submit revised drug product specifications as per USP along with fee of
Rs. 7,500/- for pre-approval change/correction in drug product specifications as per as per Notification
No. F.7-11/2012-B&A/DRAP dated 07th May, 2021.
Firm’s response: Firm has submitted fee of Rs. 7,500/- vide deposit slip# 764518731377 for change of
drug product specifications to USP.
1321. Name
- and address of M/s Novex Pharmaceuticals. Plot # 54,S6, National Industrial
manufacturer / Applicant Zone RCCI, Rawat, Islamabad
Brand Name + Dosage Form + Pironox 20mg/ml Injection
Strength
Piroxicam…20mg
Type of Form Form-5
Approval status of product in Approved by ANSMA of France
Me-too status (with strength and Rheupain injection of M/s Mediate Pharma (Reg.#061926)
dosage form)
GMP status GMP inspection conducted on 12-020-2019 recommends grant of
DML.
Remarks of the Evaluator II: Latest inspection report conducted within last three years shall be submitted.
1322. Name
Brand Name + Dosage Form + Water for Injection 5ml
Strength
Composition "Each Ampoule Contains:
Water For Injection….. 5ml"
Pharmacological Group Diluent
Type of Form Form-5
Approval status of product in Approved by MHRA
Me-too status (with strength and Water for injection of Martin Dow
dosage form)
DML.
1323. Name
Brand Name + Dosage Form + Cynox 1000mcg/ml Injection
Strength
Composition Each ml Ampoule Contains:
Cynacobalamin…….1000mcg
Pharmacological Group Vitamin
Type of Form Form-5
Approval status of product in Approved by MHRA
Me-too status (with strength and Cyfort Injection M/s Swiss Pharma
dosage form)
DML.
1324. Name
Brand Name + Dosage Form + Cynox plus Injection
Strength
Vitamin B1…100mg
Vitamin B6…100mg
Vitamin B12…1000mcg
Type of Form Form-5
Finished product Specifications Manufacturer’ sspecifications
Approval status of product in Neurobion solution for Injection 3ml by M/s Merck
Reference Regulatory Authorities Selbstmedikation GmbH (Germany Approved)
Me-too status (with strength and Neurolina Injection 3ml by M/s Alina Combine (Reg#076143)
dosage form)
DML.
1325. Name
Brand Name + Dosage Form + Nospasm 20mg/2ml Injection
Strength
Hyoscine N-Butylbromide........20mg
Pharmacological Group Anticholinergic
Type of Form Form-5
Finished product Specifications Manufacturer’ specifications
Approval status of product in Buscopan injection approved by Bfarm of Germany.
Me-too status (with strength and Buscocin Injection by M/s Caraway Pharmaceuticals
DML.
1326. Name
Brand Name + Dosage Form + Artim 80mg/ml Injection
Strength
Composition Each ml Ampoule Contains:
Artemether…80mg
Type of Form Form-5
Approval status of product in WHO approved formulation
Me-too status (with strength and Artesinate Injection of M/S Gray's Pharmaceuticals, Reg. No.
dosage form) 72458
DML.
II
Remarks of the Evaluator : Latest inspection report conducted within last three years shall be submitted.
1327. Name
Brand Name + Dosage Form + Metoclop 10mg/2ml Injection
Strength
Metoclopramide HCl…10mg
Pharmacological Group Antiemetic/ Dopamine D2 Receptor Antagonists
Type of Form Form-5
Approval status of product in METOCLOPRAMIDE 10mg/2ml Solution for Injection by M/s
Reference Regulatory Authorities Advanz Pharma, MHRA Approved.
Me-too status (with strength and Metanil Injection 10mg/2ml by M/s Dosaco Laboratories, Reg.
dosage form) No. 25510
DML.
monohydrate form of Metoclopramide hydrochloride and quantity of active ingredient in terms of
the equivalent amount of anhydrous metoclopramide hydrochloride with fee of Rs. 30,000/- for
correction/pre-approval change in composition as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021 along with latest inspection report conducted within last three years
1328. Name
- and address of M/s Karachi Chemical Industries pvt Ltd F/25, Estate Avenue,
manufacturer / Applicant S.I.T.E Karachi
Brand Name + Dosage Form + Ozapyn 5mg Tablet
Strength
Olanzapine …… 5mg
Type of Form Form-5
Me-too status (with strength and Olanzapine 5 mg Tablets. By: Akson Pharmaceuticals Pvt Ltd.
dosage form) Mirpur.
2020.
Submit revised label as per innovator product declaring dosage form as film coated tablet along with
submission of fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021
Olanzapine …… 5mg.
 Firm shall submit fee of Rs. 7,500/- for correction/pre-approval change to film coated tablet
as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 before issuance
1329. Name
Brand Name + Dosage Form + Ozapyn 10mg Tablet
Strength
Olanzapine…10mg
Type of Form Form-5
Me-too status (with strength and Olanzpine 10 mg Tablets. By: Akson Pharmaceuticals Pvt Ltd.
dosage form) Mirpur. (Reg.#081661)
2020.
II
Olanzapine …… 10mg.
 Firm shall submit fee of Rs. 7,500/- for correction/pre-approval change to film coated tablet
as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 before issuance
1330. Name
Brand Name + Dosage Form + Kaytine 20mg Tablet
Strength
Paroxetine…20mg
Type of Form Form-5
Approval status of product in Approved by MHRA of UK.
Me-too status (with strength and Neoxetine Tablets 20mg of M/s Neomedix Pharmaceuticals,
2020.
Submit revised label as per innovator product declaring dosage form as film coated tablet and complete
salt form of Paroxetine along with submission of fee as per notifications 7-11/2012-B&A/DRAP dated 07-
05-2021 & 13-07-2021
Decision: Approved. Firm shall submit revised label as per innovator product declaring dosage form
as film coated tablet and complete salt form of Paroxetine along with submission of fee as per
notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021 before issuance of registration
letter.
1331. Name
Brand Name + Dosage Form + Kesiflam 100mg SR Tablet
Strength
Composition Each film coated sustained release Tablet Contains:
Diclofenac Sodium…100mg
Type of Form Form-5
2020.
Decision: Approved.
1332. Name
Brand Name + Dosage Form + Cipex 125mg/5ml Suspension
Strength
Ciprofloxacin…125mg
Type of Form Form-5
Approval status of product in Approved by Registration Board on the recommended dosage
Reference Regulatory Authorities basis
dosage form) Ltd.
GMP status
studies.
Details of the accompanying diluent for reconstitution shall be submitted along with the manufacturing
area in which it will be produced
Decision: Approved. Alongwith diluent as per innovator drug product. Firm shall submit details for
source of drug substance pellets along with, COA, GMP certificate and stability studies before
1333. Name
Brand Name + Dosage Form + Repdon 1mg Tablet
Strength
Risperidone…1mg
Type of Form Form-5
Me-too status (with strength and Tablet Resjun -1 of M/s Jupiter PharmaPlot # 25, St# S6 RCCI,
dosage form) Rawat Islamabad. (Reg.# 081921)
2020.
Remarks of the Evaluator II: Submit revised label as per innovator product declaring dosage form as film
coated tablet along with submission of fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021
as film coated tablet along with submission of fee as per notifications 7-11/2012-B&A/DRAP dated
07-05-2021 & 13-07-2021 before issuance of registration letter.
1334. Name
Strength
Risperidone…3mg
Type of Form Form-5
Me-too status (with strength and Becalm 3mg Tablet of M/s Maple Pharmaceuticals, Karachi
2020.
Remarks of the Evaluator II: Submit revised label as per innovator product declaring dosage form as film
coated tablet along with submission of fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021
& 13-07-2021
1335. Name
- and address of M/s Karachi Chemical Industries Pvt. Ltd F/25, Estate
manufacturer / Applicant Avenue, S.I.T.E Karachi
Strength
Risperidone…4mg
Type of Form Form-5
Me-too status (with strength and Riss 4mg Tablet of M/s M/s Shawan Pharmaceuticals, Islamabad
2020.
1336. Name
Brand Name + Dosage Form + Tadol 100mg/2ml Injection
Strength
Tramadol…….100mg
Pharmacological Group Opioid Analgesic
Type of Form Form-5
Me-too status (with strength and Tremomed 100mg injection by M/s Medicraft Pharmaceuticals
dosage form) (Pvt.) Ltd. (Reg#064484)
2020.
Submit revised label as per innovator product declaring salt form of drug substance along with submission
of fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-07-2021
Decision: Approved. Firm shall submit revised label as per innovator product declaring salt form of
drug substance along with submission of fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-
2021 & 13-07-2021 before issuance of registration letter.
1337. Name
Brand Name + Dosage Form + Cipex 250mg/5ml Suspension
Strength
Ciprofloxacin……..250mg
Type of Form Form-5
Me-too status (with strength and Quash suspension of M/s Wilshire Laboratories Pvt. Ltd.
dosage form)
2020.
studies.
Details of the accompanying diluent for reconstitution shall be submitted along with the manufacturing
area in which it will be produced
Decision: Approved. Firm shall submit details for source of drug substance pellets along with, COA,
GMP certificate and stability studies.
1338. Name
- and address of M/s Helix Pharma Pvt Ltd. Hakimsons House, A/56, S.I.T.E
manufacturer / Applicant Manghopir Road, Karachi, Pakistan
Brand Name + Dosage Form + Apzole Tablets 15mg
Strength
Aripiprazole……15mg
Type of Form Form-5
Me-too status (with strength and Aripa tablet 15 mg by M/s Platinum Reg. No. 055709
dosage form)
GMP status GMP certificate was issued based on inspection conducted on
29 October 2020.
Reference for drug product specifications shall be submitted.
Firm has referred to USP specification with submission of fee of Rs. 7,500/- vide deposit slip#
7619139035.
1339. Name
Brand Name + Dosage Form + Doris 200000 Chews
Strength
Cholecalciferol …200000 IU
Pharmacological Group Vitamin D
Type of Form Form-5
dosage form)
29 October 2020.
Decision: Deferred fro following:
1340. Name
Strength
Type of Form Form-5
Me-too status (with strength and Aripaze tablet 20 mg by M/s Global Reg. No. 054729
dosage form)
29 October 2020.
9640161993.
1341. Name
Strength
Type of Form Form-5
Me-too status (with strength and Apify 30mg Tablet by M/s Akhai Pharma (Reg#76249)
dosage form)
29 October 2020.
Firm has referred to USP specification with submission of fee of Rs. 7,500/- vide deposit slip# 52065006.
1342. Name
- and address of M/s Helix Pharma Pvt. Ltd. Hakimsons House, A/56, S.I.T.E
Strength
Type of Form Form-5
Me-too status (with strength and Aripa tablet 10 mg by M/s Platinum Reg. No. 055708
dosage form)
29 October 2020.
886684540944.
1343. Name
Brand Name + Dosage Form + Zercept Tablet 10mg
Strength
Type of Form Form-5
29 October 2020.
Firm has referred to USP specification with submission of fee of Rs. 7,500/- vide deposit slip# 99503387.
1344. Name
Brand Name + Dosage Form + Zercept Tablet 5mg
Strength
Type of Form Form-5
29 October 2020.
17420483727.
1345. Name
Brand Name + Dosage Form + Misotol 200mcg Tablet
Strength
Misoprostol……..200mcg"
Pharmacological Group Cytoprotective agent
Type of Form Form-5
Me-too status (with strength and Tecmiso 200mcg tablet of M/s NabiQasim Karachi (Reg.#
29 October 2020.
 Clarification shall be submitted in label claim regarding physical form of drug substance whether
it is in “dispersion form” of pure drug substance.
Firm’s reply:
Please note that the specification of finished form of product is Innovator’s Specification.
Regarding physical form of drug substance, please note that we will use the dispersion form of misoprostol
(with 1% HPMC) as the pure drug substance available in liquid form which is highly unstable.
Firm has submitted following revised label claim along with fee of Rs. 7,500/- vide deposit slip#
2696171561:
“Misotol 200mcg Tablets
Each Tablet contains;
Misoprostol (as 1% HPMC) …….200mcg”
 IP monograph is available for applied formulation.

Decision: Approved with IP specifications as per following label claim:
Misoprostol (as 1% HPMC) …….200mcg”
Firm shall submit deifferential fee of Rs. 22,500/- for correction/pre-approval change in label claim
1346. Name
Brand Name + Dosage Form + Misotol 100mcg Tablet
Strength
Misoprostol……..100mcg"
Type of Form Form-5
29 October 2020.
II
Firm’s reply:
Please note that the specification of finished form of product is Innovator’s Specification.
Regarding physical form of drug substance, please note that we will use the dispersion form of misoprostol
(with 1% HPMC) as the pure drug substance available in liquid form which is highly unstable.
Firm has submitted following revised label claim along with fee of Rs. 7,500/- vide deposit slip#
724835384:
Misotol 100mcg Tablets
Misoprostol (as 1% HPMC) ……. 100mcg”
 IP monograph is available for applied formulation.

Firm shall submit deifferential fee of Rs. 22,500/- for correction/pre-approval change in label claim
1347. Name
` and address of M/s Helix Pharma Pvt Ltd. Hakimsons House, A/56, S.I.T.E
Brand Name + Dosage Form + Angiclor Tablet 90mg
Strength
Ticagrelor….…90mg
Pharmacological Group Anticoagulant/ antiplatelet agent
Type of Form Form-5
Me-too status (with strength and Virata tablet of M/s Sami Pharma
dosage form)
29th October 2020.
Frim’s reply:
We have submitted 06 months stability data (Accelerated & Real Time) of said product on 19th July,2022.
Decision: Deferred for evaluation of submitted stability studies data on its turn.
1348. Name
` and address of M/s Davis Pharmaceuticals Laboratories. Plot No. 121,
manufacturer / Applicant Industrial Triangle, kahuta Road, Islamabad
Brand Name + Dosage Form + Misodic 75mg/200mcg Tablet
Strength
Misoprostol……200mcg
Pharmacological Group Prostaglandin E1 Analogue, NSAID
Type of Form Form-5
Approval status of product in Arthrotec of USFDA Approved
Me-too status (with strength and Cytopan-75 Tablets by Getz Pharma (Reg#024014)
dosage form)
2022.
 Submit revised label claim as per innovator product declaring the misoprostol layer as immediate
release and diclofenac sodium layer as enteric coated along with submission of relevant fee as per.
 Submit evidence of availability of bilayer compression machine.
Decision: Deferred for evidence of availability of “Bi-layer compression” machine along with its
IQ,OQ & PQ reports.
1349. Name
Brand Name + Dosage Form + Pathoderm B Cream
Strength
Composition Each Tube Contains:
Fusidic Acid…0.2%
Betamethasone As Valerate…0.1%
Pharmacological Group Corticosteroids, potent, combinations with antibiotics
Type of Form Form-5
Approval status of product in Xemacort 20 mg/g + 1 mg/g cream (MHRA Approved)
Me-too status (with strength and Beta-F Cream by Atco Laboratories (Reg# 082104)
dosage form)
2022.
1350. Name
Brand Name + Dosage Form + Doioraleze 2mg Capsule
Strength
Loperamide HCl……2mg"
Pharmacological Group Anti-propulsives
Type of Form Form-5
Approval status of product in GASTRO-STOP loperamide hydrochloride 2mg capsules. TGA
Reference Regulatory Authorities approved
Me-too status (with strength and IMODIUM 2MG Capsule. Reg. No. 6159
dosage form)
2022.
II
Decision: Approved.
1351. Name
Brand Name + Dosage Form + Flucole 150mg Capsule
Strength
Fluconazole…150mg
Type of Form Form 5
Approval status of product in Azocan 150 of M/s FDC International Ltd. approved by MHRA
Reference Regulatory Authorities of UK
Me-too status (with strength and Fantizol Capsule by M/ Apex Karachi. (Reg#073551)
dosage form)
2022.
Remarks of the Evaluator II: Firm has applied in-house specifications whereas JP monograph is available
for applied formulation.
Decision: Approved with JP specifications. The firm shall submit fee of Rs. 7500/- for correction/pre-
05-2021 before issuance of registration letter.
1352. Name
i and address of M/s Davis Pharmaceuticals Laboratories. Plot No. 121,
Brand Name + Dosage Form + Davifucin 20mg Ointment
Strength
Composition Each Tube Contains:
Sodium Fusidate…20mg/Gm
Pharmacological Group Antibiotic for topical use
Type of Form Form 5
Approval status of product in Approve by MHRA of UK
Me-too status (with strength and Fusimax 2% ointment of M/s Maxitech
dosage form)
2022.
1353. Name
Brand Name + Dosage Form + Topogyne 200mcg Tablet
Strength
Misoprostol…….200mcg"
Type of Form Form-5
2022.
“Each Tablet contains:
composition as per notification No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before
1354. Name
Brand Name + Dosage Form + Davisulide 100mg Tablet
Strength
Nimesulide…100mg
Pharmacological Group Anti-rheumatic
Type of Form Form-5
Finished product Specifications Manufacturer’s specification
Me-too status (with strength and Nims tablet by M/s Sami
dosage form)
2022.
 Registration Board in its 271st meeting keeping in view the approval status of Nimesulide 100mg
tablet in EMA, the Registration Board approved the formulation of Nimesulide Tablets 100mg
with a pack size for 15 days as per recommendations of EMA only for the following clinical
indications as a second-line choice.
a) Treatment of acute pain
b) Primary dysmenorrhea
1355. Name
Brand Name + Dosage Form + Dermazole Cream
Strength
Composition Each tube Contains:
Betamethasone Dipropionate Eq. To Betamethasone……0.05%
Clotrimazole………1%
Pharmacological Group Antifungal with corticosteroids
Type of Form Form-5
Approval status of product in LOTRISONE® (clotrimazole and betamethasone dipropionate)
Reference Regulatory Authorities cream, for topical use (1%/0.05%). USFDA Approved
Me-too status (with strength and Holfungin Cream. Reg. No. 67598
dosage form)
2022.
Decision: Approved.
1356. Name
Brand Name + Dosage Form + Betasone 0.1% Cream
Strength
Composition "Each Gram Contains:
Betamethasone As Valerate…1mg"
Type of Form Form-5
Approval status of product in Betamethasone (as) Valerate 0.1%w/w Cream. MHRA
Me-too status (with strength and Beason Cream 0.1%. Reg. No. 80082
dosage form)
2022.
II
Remarks of the Evaluator : BP monograph is available for applied formulation.
1357. Name
Brand Name + Dosage Form + Daviscab Cream
Strength
Permethrin……50mg
Pharmacological Group Pyrethrines, incl. synthetic compounds
Type of Form Form-5
Approval status of product in Betamethasone (as) Valerate 0.1%w/w Cream. MHRA
Me-too status (with strength and Permisan 5% cream of M/s Sante Reg. No. 061887
dosage form)
2022.
b. Deferred cases
1358. Name and address of "M/s Next Pharmaceutical Products Private Limited. Plot
manufacturer / Applicant No. 44 A-B, Sundar Industrial Estate, Lahore
Contract manufacturing by
M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-
km,Ferozepur Road, Lahore"
Brand Name +Dosage Form + D-Next 5mg/ml IV/IM Injection
Strength
Composition "Each 1ml Contains:
Cholecalciferol (Vitamin D3)…5mg"
Diary No. Date of R& I & fee Dy. No 17650 dated 11-05-2018 Rs.20,000/- Dated 11-05-
2018 Rs. 30,000/- dated 27-06-2019
Type of Form Form 5
Finished product Manufacturer specifications
Specifications
Authorities
Me-too status (with strength D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
and dosage form)
GMP status Last GMP inspection dated 5th & 27th December, 2017
conclusion by Panel ―The firm (M/s NovaMed
Pharmaceuticals Pvt. Ltd. Lahore) is compliant to Good cGMP
guidelines at the time of inspection.
Remarks of the EvaluatorII Form 5 was initially submitted from the manufacturer i.e. M/s
Novamed Pharmaceuticals (Pvt.) Ltd. 28-km, Ferozepur Road,
Lahore.
Subsequently fresh Form 5 has been submitted by the applicant
i.e., M/s Next Pharmaceutical Products Private Limited. Plot
No. 44 A-B, Sundar Industrial Estate, Lahore, dated 25-07-
2019.
Reference product is available in ampoule whereas firm
has applied for vial.
st
Decision of 291 meeting: Registration Board decided to defer all applied products of contract
manufacturing from M/s Novamed Pharmaceuticals (Pvt) Ltd. 28-km, Ferozepur Road, Lahore,
for assessment of manufacturing and quality control capacity of M/s Novamed Pharmaceuticals
(Pvt) Ltd. 28-km, Ferozepur Road, Lahore. Moreover, clarification shall be submitted regarding
container closure system, since reference product is available in ampoule whereas firm has
applied for vial.
Firm’s response: Firm has referred to the Capacity assessment inspection report of M/s Novamed
Pharmaceuticals Pvt Ltd, 28km Ferozepur Road, Lahore presented in 295th meeting of
Registration Board wherein Board decided to allow contract manufacturing from M/s Novamed
Pharmaceuticals Pvt Ltd, 28km Ferozepur Road, Lahore for following sections:
 Dry Powder Injection (Cephalosporin) Section

 Dry Powder Suspension (Cephalosporin) Section
 General Liquid Injection Vials (SVP)
Decision of 320th meeting: Registration Board deferred the applications of contract
manufacturing from M/s Medisave pharmaceuticals, Plot 578-579, Sunder Industrial Estate,
Lahore, Pakistan for submission of upgradation plan regarding increase in testing capacity
especially HPLC, microbiological testing etc to cater the need of pharmacopoeial testing of
already registered drug products, products under development and contract manufactured
products as decided in 317th meeting of Registration Board.
Remark Evaluator: Subsequent evaluation of record has revealed that decision of Board was
erroneously drafted as deferred considering the drug product manufacturer as M/s Medisave,
whereas firm has applied for contract manufacturing from Novamed Pharmaceuticals (Pvt) Ltd.
Decision: Registration Board noted the information and decided to approve the applied
product of D-Next 5mg/ml IV/IM Injection with innovator’s specification. The firm shall submit
fee of Rs. 7500/- for correction/pre-approval change in product specifications as per notification
No.F.7-11/2012-B&A/DRAP dated 07-05-2021 before issuance of registration letter.
satisfactory capacity assessment of manufacturing and testing facility of M/s Bio Mark
Pharmaceuticals. Plot No. 527, Sundar Industrial Estate, Lahore.
1359. Name and address of manufacturer / M/s Barrett Hodgson Pakistan Pvt Ltd.
Applicant F/423, SITE, Karachi
Brand Name + Dosage Form + Telbar Plus Tablet 40mg/5mg
Strength
Telmisartan…40mg
Amlodipine besylate eq to Amlodipine…5mg
Diary No. Date of R&I & Fee Dy.No 8173 dated 25-02-2019 Rs.20,000/- Dated 25-02-2019
Type of Form Form-5
Finished product Specification Manufacturer's Specification
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s, 30’s, 60’s: Rs.600/-, Rs.840/-, Rs.1200/-,
Rs.1680/-, Rs.1800/-, Rs.3600/-, As per SRO
reference regulatory authorities
Me-too status Telday Plus 40/5 Tablets of M/s. Novamed Pharmaceuticals
GMP status Dated: 16th-28th Aug, 2018.
Conclusion:
The firm has complied and addressed all the observations as
advised in the last inspection. Overall found satisfactory and
progressive towards good level of GMP compliance.
Decision of 296th meeting: Deferred for confirmation of bi-layered tablet machine and revision of
manufacturing outline.
Firm’s response: Firm has submitted following:
 Commercial invoice and operational manual for Rotary press machine ZPW-26 having capacity
of bilayer compression.
 Revised manufacturing outline for bi-layer tablet.
 GMP certificate issue don basis of inspection conducted on 06-12-2021.
 Reference of their already registered bi-layer product of Mobikare plus tablet 50/200
(Diclofenac/Misoprostol)
B&A/DRAP dated 07-05-2021 along with IQ, OQ & PQ reports for the “bilayer compression
machine” before issuance of registration letter.
Strength
Telmisartan…80mg
Type of Form Form-5
Pack size & Demanded Price : as per SRO
Conclusion:
Strength
Telmisartan…80mg
Type of Form Form-5
Conclusion:
Decision of 323rd meeting: Approved with USP specification. The firm shall submit fee of Rs. 7500/-
for correction/pre-approval change in product specifications as per notification No.F.7-11/2012-
Strength
Composition Each tablet contains
Telmisartan…40mg
Type of Form Form-5
Conclusion:
Decision of 323rd meeting: Approved with USP specification. The firm shall submit fee of Rs. 7500/-
for correction/pre-approval change in product specifications as per notification No.F.7-11/2012-
1363. Name and address of manufacturer / M/s Sapient Pharma 123/S, Quaid e Azam Industrial Estate, Kot
Applicant Lakhpat, Lahore
BY
M/s Bio Mark Pharmaceuticals. Plot No. 527, Sundar Industrial
Estate,Lahore
Brand Name +Dosage Form + SMP Insta Sachet 20/1680mg
Strength
Omeprazole Sodium…20mg
Sodium Bicarbonate….1680mg
Diary No. Date of R& I & fee Dy. No. 12427 dated 06.03.2019
Rs. 50,000/- dated 04.03.2019
Pharmacological Group Proton pump inhibitor and antacid
Type of Form Form 5
Finished Product Specification Not submitted. Available in USP
Approval status of product in Omeprazole and sodium bicarbonate (Packet) for oral suspension.
Reference Regulatory Authorities. approved by US-FDA
Me-too status Risek Insta Sachet. Reg. No. 58547
GMP status GMP inspection reports required.
Remarks of the Evaluator.  The drug product specifications have not been evaluated.
The firm did not submit the requirements /documents as per
enclosure of Form 5.
 The firm did not submit copy of contract manufacturing
agreement.
 The fee has been deposited by M/s Biomark
Pharmaceuticals.
Decision of 317th meeting: Deferred for submission of:
 Requirements /documents as per enclosure of Form 5.
 copy of contract manufacturing agreement.
 Application Fee of Rs. 75,000/-.
 Complete enclosures of Form 5.
 Contract agreement between M/s Sapient pharma and M/s Bio Mark Pahrma
 Drug product specifications as per USP
 GMP certificate of Bio-mark issued on basis of inspection conducted on 13-02-2020
by
Estate,Lahore
Brand Name +Dosage Form + SMP Insta Sachet 40/1680mg
Strength
Omeprazole Sodium…40mg
Sodium Bicarbonate….1680mg
Rs. 50,000/- dated 04.03.2019
Pharmacological Group Proton pump inhibitor and antacid
Type of Form Form 5
Approval status of product in Omeprazole and sodium bicarbonate (Packet) for oral suspension.
Reference Regulatory Authorities. approved by US-FDA
Me-too status Risek Insta Sachet. Reg. No. 58548
 The firm did not submit the requirements /documents as per
agreement.
Pharmaceuticals.
Decision: Deferred for submission of:
 requirements /documents as per enclosure of Form 5.
 GMP certificate of Bio-mark issue don basis of inspection conducted on 13-02-2020
1365. Name and address of manufacturer / M/s Sapient Pharma 123/S, Quaid e Azam Industrial Estate,
Applicant Kot Lakhpat, Lahore
BY
Estate,Lahore
Brand Name +Dosage Form + Sapeso Capsule 20mg
Strength
Esomeprazole as Esomeprazole Magnesium (Enteric Coated
Pellets)…20mg
Rs. 50,000/- dated 04.03.2019
Type of Form Form 5
Pack size & Demanded Price 2x7’s; As per SRO
Approval status of product in Esomeprazole magnesium Capsule 20mg. USFDA Approved
Me-too status Esorid 20mg Capsules. Reg. No. 33097
The firm did not submit the requirements /documents as per
agreement.
Pharmaceuticals.
 The firm did not submit the source of pellets and all required
data.
 source of pellets, GMP certificate of the source, and CoA and stability data of three batches of the
pellets conducted in zone IV-A.
 Documents for source of pellets form M/s Vision pharma
BY
Estate,Lahore
Brand Name +Dosage Form + Sapeso Capsule 40mg
Strength
Esomeprazole as Esomeprazole Magnesium (Enteric Coated
Pellets)…40mg
Rs. 50,000/- dated 04.03.2019
Type of Form Form 5
Pack size & Demanded Price 2x7’s; As per SRO
Approval status of product in Esomeprazole magnesium Capsule 40mg. USFDA approved
Me-too status Espra Capsule 40mg. Reg. No. 33051
agreement.
Pharmaceuticals.
 The firm did not submit the source of pellets and all required
data.
 Source of pellets, GMP certificate of the source, and CoA and stability data of three batches of the
pellets conducted in zone IV-A.
 Documents for source of pellets form M/s Vision pharma
BY
Estate,Lahore
Brand Name +Dosage Form + Moseeta Sachet 3g
Strength
Dioctahedral Smectite…3gm
Rs. 50,000/- dated 04.03.2019
Pharmacological Group Antidiarrhoeal
Type of Form Form 5
Finished Product Specification Not submitted.
Approval status of product in Diosmectal 3g powder of Diosmectite for oral suspension,
Reference Regulatory Authorities. approved by Italian Medicines Agency
Me-too status Semetamed 3.0g Sachets. Reg. No. 61925
agreement.
Pharmaceuticals.
 Application Fee of Rs. 75,000/-
Decision: Approved with Innovator’s specification. The firm shall submit fee of Rs. 7500/- for
Brand Name + Dosage Form + Strength LYCLEAR Lotion 5% w/v
Permethrin….50mg (5% w/v)
Diary No. Date of R & I & fee Dy. No.5988 dated 23-05-2011, Rs. 8,000/- challan dated
21-05-2011 (Photocopy),
(Photocopy)
Pharmacological Group Scabicide
Type of Form Form 5
Approval status of product in Reference MHRA approved as Permethrin Lotion 5% w/w
Regulatory Authorities TGA Australia approval as (QUELLADA SCABIES
TREATMENT LOTION permethrin 50mg/mL bottle)
Me-too status Dynarix (Permethrin) 5% Lotion (Each gm contains
permethrin 50mg) of M/s Dynatis Pakistan Ltd. Lahore.
Remarks of the Evaluator (PEC-XVII)  External liquid preparation section (General) Section
approval granted vide letter No. F. 1-30/84-Lic (Vol.I)
dated 27-04-2017.
 V R & I record verified. Details incorporated in relevant
column above.
Decision: Deferred for submission of following documents:
 Confirmation of required manufacturing facility / section from Licensing Division.
 Submission of applicable fee as per notifications 7-11/2012-B&A/DRAP dated 07-05-2021 & 13-
07-2021 for correction/pre-approval change/ in product specifications.
Firm’s response: Firm has submitted GMP certificate issued on basis of inspection conducted on 16-06-
2021, declaring availability of External Liquid preparation general section and Cream/ointment section.
Frim has also referred to their already registered product of Lindane lotion 1% vide registration# 060636.
Decision: Deferred for confirmation from Licensing Division for availability of required
manufacturing facility for applied dosage form of “Lotion”.
Case no. 02 Registration applications of newly granted DML or New section (Human)
a. New cases
1369. Name, address of Applicant / Marketing M/s.Carer pharmaceuticals plot No.27 RCCI
Authorization Holder Industrial estate Rawat Islamabad Pakistan.
Name, address of Manufacturing site. M/s.Carer pharmaceuticals plot No.27 RCCI
Industrial estate Rawat Islamabad Pakistan.
☐ Importer
☐ Export sale
Details of fee submitted Rs.30,000/- dated 25-01-2022
The proposed proprietary name / brand name Caracip 500mg Tablet
Pharmaceutical ingredient (API) per unit Ciprofloxacin as hydrochloride …….. 500mg
Pharmaceutical form of applied drug Film coated tablet
The status in reference regulatory authorities CIPRO 500mg tablet by Bayer Healthcare USFDA
Approved.
For generic drugs (me-too status) CFLOX 500 mg Tablet by Global
GMP status of the Finished product New license granted on 07/06/2021
manufacturer Tablet, Capsule, Dry powder and Ampule (General &
General Antibiotic) section approved.
Name and address of API manufacturer. M/s Saakh Pharma Pvt. Ltd., Plot # C-7/1, North
Western Industrial Zone Port Qasim, Karachi
verification, batch analysis and justification of
Module III (Drug Substance) Official monograph of Ciprofloxacin Hydrochloride
is present in USP. The firm as submitted detail of
of manufacturing process and controls, specifications,
analytical procedures and its verification, batch
studies of drug substance
Real time: 30°C ± 2°C / 65% ± 5%RH for 72 months
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6 months
Module-III (Drug Product): The firm has submitted detail of manufacturers,
impurities, specifications, analytical procedure
(including dissolution testing at acidic and buffer
medium) and its verification studies, batch analysis
and justification of specification, reference standard,
product.
dissolution profile against the brand leader that is Ciproxin 500mg
Tablets by Bayer Healthcare performing quality tests.
CDP has been performed against the same brand that
is Ciproxin 500mg Tablet by Bayer Healthcare in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH
6.8).
product linearity, range, accuracy, precision, specificty.
Manufacturer of API M/s Saakh Pharma Pvt. Ltd., Plot # C-7/1, North Western Industrial Zone Port
Qasim, Karachi
API Lot No. 21GN90039
Description of Pack
Alu-Alu blister packed in unit carton (1×10’s)
Batch No. T-001 T-002 T-003
Batch Size 2500 tab 2500 tab 2500 tab
No. of Batches 03
1370. Name, address of Applicant / Marketing M/s.Carer pharmaceuticals plot No.27 RCCI
Authorization Holder Industrial estate Rawat Islamabad Pakistan.
Name, address of Manufacturing site. M/s.Carer pharmaceuticals plot No.27 RCCI
Industrial estate Rawat Islamabad Pakistan.
☐ Importer
☐ Export sale
Dy. No. and date of submission Dy.No 6505 dated 09-03-2022
The proposed proprietary name / brand name Caracip 250mg tablet
Pharmaceutical ingredient (API) per unit Ciprofloxacin as hydrochloride …….. 250mg
The status in reference regulatory authorities CIPRO 250mg tablet by Bayer Healthcare USFDA
Approved.
For generic drugs (me-too status) CFLOX 250 mg Tablet by Global, Reg. No. 084114
GMP status of the Finished product New license granted on 07/06/2021
manufacturer Tablet, Capsule, Dry powder and Ampule (General &
General Antibiotic) section approved.
Name and address of API manufacturer. M/s Saakh Pharma Pvt. Ltd., Plot # C-7/1, North
Western Industrial Zone Port Qasim, Karachi
Module III (Drug Substance) Official monograph of Ciprofloxacin Hydrochloride
is present in USP. The firm as submitted detail of
of manufacturing process and controls, specifications,
Batches: (P11-001, P11-002, P11-003)
product.
dissolution profile against the brand leader that is Ciproxin 250mg
Tablets by Bayer Healthcare performing quality tests.
is Ciproxin 250mg Tablet by …Bayer Healthcare in
Acid media (pH 1.0-1.2) & Phosphate Buffer (pH
6.8).
product linearity, range, accuracy, precision, specificty.
Manufacturer of API M/s Saakh Pharma Pvt. Ltd., Plot # C-7/1, North Western Industrial Zone Port
Qasim, Karachi
API Lot No. 21GN90039
Description of Pack
Batch No. T-001 T-002 T-003
No. of Batches 03
1. Reference of previous approval of applications The firm has not submitted any document.
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 83/2020-DRAP(K)
manufacturer issued by concerned regulatory issued by CFDA valid till 23/06/2023.
3. Documents for the procurement of API with  Local purchase from SAAKH PHARMA
approval from DRAP (in case of import). KARACHI.
4. Data of stability batches will be supported by Submitted

chromatograms,
5. Compliance Record of HPLC software 21CFR N/A
& audit trail reports on product testing
6. Record of Digital data logger for temperature N/A
and humidity monitoring of stability chambers
Remarks of EvaluatorII:
Section# Observations Firm’s response

3.2.S.4.1  Drug substance specifications & analytical procedure Drug substance manufacturer has
submitted form M/s Saakh Pharma, mention both claimed that the drug substance
USP & BP as reference. Clarification shall be complies both BP & USP
submitted for claiming both standards as monograph while M/s Carer
specifications. Pharma has adopted USP
 Copies of the Drug substance specifications and specifications and analytical
analytical procedures used for routine testing of the procedure for Drug substance.
Drug substance /Active Pharmaceutical Ingredient
by Drug Product manufacturer is required.
3.2.S.4.3 Analytical Method Verification studies including Submitted.
specificity, accuracy and repeatability (method precision)
performed by the Drug Product manufacturer shall be
submitted.
3.2.S.4.4 Submitted COA of drug substance mentions Firm has declared it a
manufacturing date as December 2021, whereas date of typographical error and has
analysis is declared as 25-06-2021. submitted revised COA.
3.2.S.5 COA of primary / secondary reference standard including Submitted.
source and lot number shall be provided.
3.2.S.7 Long term stability studies data of 3 batches for drug Firm has submitted long term
substance shall be submitted form M/s Saakh pharma. stability studies data as per Zne
IVa of three batches till 48
months.
3.2.P.2.2.1 CDP studies have been performed with two sampling
time points only whereas relevant guidelines recommend
at least three sampling time points.
 Performance of precision & specificity parameter Firm has submitted revised
3.2.P.5.3 shall be submitted for analytical method verification analytical method verification
studies. studies with performance of
 Results of accuracy parameter are not as per the precision & specificity parameter.
specified concentrations in the method.
3.2.P.6  COA of primary / secondary reference standard Submitted.
including source and lot number shall be provided.
3.2.P.8.3  Analytical results mentioned in stability summary  Firm has submitted revised
sheets are different from that declared in batch stability summary sheets
analysis COA. declaring results &
 Manufacturing date mentioned on Stability summary manufacturing date as per
sheets is different form that declared on COAs. submitted COA.
 UV wavelength declared on submitted  Firm has submitted complete
chromatograms of Assay analysis is different from batch manufacturing records
that mentioned in method. of all three stability batches.
 HPLC chromatograms have been submitted from
dissolution analysis whereas USP monograph
recommends USP spectrophotometric method.
 Complete batch manufacturing record shall be
submitted for all three stability batches.
Decision: Registration Board approved the applications of Caracip 500mg tablet and Caracip 250mg
tablet with change of brand name. Registration letter will be issued upon submission of following:
 CDP studies against the innovator product as per time points recommended by relevant guidelines
 Performance of stability studies with revised analyticalmethod as per USP at next time point of
long term stability studies.
b. Deferred cases
1371. Name, address of Applicant / Marketing M/s May & Baker Pharmaceuticals (Pvt.) Ltd.
Authorization Holder 45 Km, Thokar Multan road, Lahore
Name, address of Manufacturing site. M/s May & Baker Pharmaceuticals (Pvt.) Ltd. 45
Km, Thokar Multan road, Lahore
☐ Importer
☐ Export sale
Evidence of Manufacturing facility Issuance of DML vide letter no. F.1-10/2019-Lic.
Dated 29-04-2022 for sections of Injectable
ampoule (General), Capsule section (general), Dry
powder suspension section (general), Dry powder
vial section (general)
The proposed proprietary name / brand name V-Drop 5mg/ml Injection
Pharmaceutical ingredient (API) per unit Vitamin D3 …….5mg
Pharmaceutical form of applied drug Liquid injection
Reference to Finished product specifications Innovator’s Specs
Proposed Pack size 1ml(1x1,s)
The status in reference regulatory authorities Approved by ANSM of France.
For generic drugs (me-too status) Indrop D Injection M/s Neutro Pharmaceutical Pvt
Ltd Pakistan., Reg. No. 023170
GMP status of the Finished product manufacturer Issuance of DML vide letter no. F.1-10/2019-Lic.
Dated 29-04-2022 for sections of Injectable
ampoule (General), Capsule section (general), Dry
powder suspension section (general), Dry powder
vial section (general)
Name and address of API manufacturer. M/s Sichuan Province Yuxin Pharmaceutical Co.,
Ltd., Weichend Jinhe East Road, Shifang City,
Sichuan Province, China.
Module III (Drug Substance) The firm as submitted detail of nomenclature,
container closure system and stability studies of
drug substance.
Real time: 5°C ± 3°C
impurities, specifications, analytical procedure and
its verification studies, batch analysis and
drug product.

dissolution profile against the Indrop D injection by M/s Neutro.
Analytical method validation/verification of Method validation studies have been submitted.
product
Manufacturer of API M/s Sichuan Province Yuxin Pharmaceutical Co., Ltd., Weichend Jinhe East
Road, Shifang City, Sichuan Province, China.
API Lot No. VD3220513
Description of Pack
Glass ampoules
Batch No. Trial 01 Trial 02 Trial 03
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of DML# SC 20160429 issued by NMPA
manufacturer issued by concerned regulatory valid till 18-10-2025.
3. Documents for the procurement of API with Not submitted.
5. Compliance Record of HPLC software 21CFR & N/A
time and accelerated).
3.2. S.4.1 Drug Substance Specifications, Firm has submitted analytical method verification report
Analytical Procedure & Analytical for the drug substance and has referred to USP
Method Verification Studies Shall Be monograph of Cholecalciferol for the drug substance
Submitted from M/s May & Baker. specifications and analytical procedure.
3.2.S.4.4 COA of relevant batch of API from Submitted.
drug substance manufacturer shall be
submitted used for manufacturing of
drug product trial batches.
3.2.P.5.4 Submitted COA declares average It is a typo error, average volume is mentioned for 5
volume as 5ml. Justification shall be number of units.
submitted in this regard.
3.2.P.6 COA of reference/working standard Submitted.
shall be submitted.
3.2.P.8  Complete batch manufacturing  Firm has submitted batch manufacturing record for
record of three stability batches three stability batches.
shall be submitted.  Firm has submitted copy of DML# 20160429 valid
 GMP certificate of the drug till 18-10-2025 for the drug substance
substance manufacturer shall be manufacturer.
submitted.  Firm has stated that drug substance was borrowed
 Documents confirming from M/s Global Pharma and has submitted
procurement of drug substance commercial invoice in attested by AD DRAP I&E
shall be submitted. Islamabad dated 27-08-2021 in name of M/s Global
Pharma for import to 15Kg Vitamin D3.
Decision: Approved.
 Registration letter will be issued upon verification of API loan letter by M/s Global Pharmaceuticals.
Case no. 03 New Registration applications on Form 5F (Human)

a. New Cases (Human)
1372. Name, address of Applicant / Marketing M/s Scilife Pharma (Pvt.) Ltd., 16, K.O.C.H.S.
Authorization Holder Amir Khusro Road, Karachi-75350, Pakistan
Name, address of Manufacturing site. M/s Scilife Pharma (Pvt.) Ltd., Plot # FD-57/58-A2,
Korangi Creek Industrial Park, Karachi
☐ Importer
☐ Export sale
Details of fee submitted Rs.20,000/- dated 16-04-2021 & Rs.10,000/- dated 20-09-
2021
The proposed proprietary name / brand name SciAmpa-M 5+500 mg tablet
Pharmaceutical ingredient (API) per unit Empagliflozin………………..5mg
Metformin HCl…………..500mg
Pharmacotherapeutic Group of (API) Anti-hyperglycemic agents (A10BD20)
Reference to Finished product specifications Manufacturer’s
Proposed Pack size 14’s & 28’s
The status in reference regulatory authorities Synjardy 5+500 mg tablet (EMA Approved).
For generic drugs (me-too status) XENGLU-MET 5MG +500mg Tablet of Hilton Pharma
(Reg #093102)
GMP status of the Finished product Renewal of license granted on 01/06/2021
manufacturer Tablet, Capsule, Ointment/Cream, Sachet, Dry Powder
Inhalaer & Dry Powder suspension (General) sections
approved.
Last inspection conducted on 16-11-2021 and concludes

that firm was considered to be operating at Good level of
compliance
Name and address of API manufacturer. API manufacturer of Empagliflozin
Name: Fuxin Long Rui Pharmaceutical CO., Ltd.
Address: Fluoride Industrial Park, Fumeng County (Yi
Ma Tu), Fuxin
City, Liaoning Province -123000, China
API manufacturer of Metformin Hydrochloride

Name: Shouguang Fukang Pharmaceutical Co., Ltd.
Address: North-East of Dongwaihuan Road, Dongcheng
Industrial Area
Summarized information related to nomenclature,
submitted.
Module III (Drug Substance) Firm has submitted detailed drug substance data for both
sources related to nomenclature, structure, general
and stability studies of drug substance.
Stability studies Firm has submitted stability study data of 3 batches of
both API at accelerated as well as real time conditions.
The real time stability data of Empagliflozin conducted at

30±2°C, 65%±5% RH. The stability study data is till 26
months.
The real time stability data of Metformin hydrochloride
conducted at 30±2°C, 75%±5% RH. The stability study
data is till 60 months.
impurities, specifications, analytical procedure (including
dissolution testing at acidic and buffer medium) and its
verification studies, batch analysis and justification of
and stability studies of drug product.
Pharmaceutical equivalence and comparative Firm has submitted Compartitive dissolution profile
dissolution profile against Xenglu Met 5+500mg Tablet of Hilton Pharma
Analytical method validation/verification of Firm has submitted analytical method validation studies
product for the applied product.
Manufacturer of API API manufacturer of Empagliflozin

Name: Fuxin Long Rui Pharmaceutical CO., Ltd.
Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin
City, Liaoning Province -123000, China
API manufacturer of Metformin Hydrochloride

Name: Shouguang Fukang Pharmaceutical Co., Ltd.
Address: North-East of Dongwaihuan Road, Dongcheng Industrial
Area
API Lot No. 0000006044 / 0000006965
Description of Pack
Alu-Alu blister packed in unit carton
Batch No. 201B20 202B20 203B20
No. of Batches 03
with stability study data of the firm (if any) product Glusimet XR 50/500mg Tablets & Glusimet XR
50/1000mg Tablets which was conducted on 16th July,
2020 and was presented in 296th meeting of Registration
Board held on 8th - 10th September, 2020.
According to the report following points were confirmed.
The firm has 21 CFR compliant HPLC software
The firm has audit trail reports available.
The firm possesses stability chambers with digital data
loggers.
2. Approval of API/ DML/GMP certificate of API Empagliflozin
manufacturer issued by concerned regulatory Copy of DML certificate No. Liao20150233 issued by
authority of country of origin. FDA of Liaoning Province valid till 20/12/2022.
Metformin HCl: Copy of GMP certificate No.

SD20190888 issued by CFDA valid till 12/03/2024.
3. Documents for the procurement of API with Empagliflozin: Firm has submitted copy of form 5,
approval from DRAP (in case of import). invoice (invoice# HN19011801-H) Dated: 18-01-2020,
cleared by DRAP Karachi office dated 30-01-2020
specifying import 10Kg Empagliflozin (Batch# E-
20190920-D02-E06-01).
Metformin HCl: Firm has submitted copy of Form 5 &
invoice (invoice# 20FK04Z4106B) Dated: 05-05-2020
from Shouguang Fukang Pharmaceutical Co., Ltd. cleared,
cleared by DRAP Karachi office dated 30-01-2020
specifying import 3000Kg Metformin HCl (Batch# A-
32612004031 & A-32612004032).
chromatograms,
etc.
5. Compliance Record of HPLC software 21CFR Submitted
6. Record of Digital data logger for temperature Submitted
correction/pre-approval change in product specifications as per notification No.F.7-11/2012-B&A/DRAP
dated 07-05-2021 before issuance of registration letter.
1373. Name, address of Applicant / Marketing M/s Daneen Pharma Private Limited 27-Sundar
Authorization Holder Industrial Estate, Sundar Raiwind Road, Lahore
Name, address of Manufacturing site. M/s Genix Pharma Private Limited 44-45B Korangi
creek road Karachi
☐ Importer
Status of application  New Drug Product (NDP)
🗵 Generic Drug Product (GDP)
☐ Export sale
Evidence of manufacturing facility Section approval letter declaring grant of Capsule
general section
The proposed proprietary name / brand name Sildos 8mg Capsule
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Silodosin….…8mg
Pharmaceutical form of applied drug Capsule
Pharmacotherapeutic Group of (API) Alpha-adrenoreceptor antagonists
Reference to Finished product specifications As per innovator’s specifications
The status in reference regulatory authorities US FDA Approved
For generic drugs (me-too status) Siloon capsule of M/s Genix
GMP status of the Finished product manufacturer GMP granted on 07/10/2021
Name and address of API manufacturer. Zhejiang Tianyu Pharmaceutical Co., Ltd, No. 15
Donghai 5th Avenue Zhejiang Provincial Chmeical
and Medical Raw Materials Base Linhai Zone
Taizhou Zhejiang China.
process and controls, , specifications, analytical
substance
specifications, analytical procedure and its
system and stability studies of drug product.
Pharmaceutical equivalence and comparative Pharmaceutical Equivalence & CDP have been
dissolution profile established against the referenc eproduct of Steglujan
tablet
Analytical method validation/verification of product Method validation studies have been submitted
including justification of system suitability,
specificity, linearity, accuracy, precision-
repeatability.
creek road Karachi
☐ Importer
☐ Export sale
Evidence of manufacturing facility Section approval letter declaring grant of Tablet
general section
The proposed proprietary name / brand name Sildos 4mg Capsule
Strength / concentration of drug of Active Each Capsule Contains:
Pharmaceutical ingredient (API) per unit Silodosin…4mg
Pharmaceutical form of applied drug Capsule
Pharmacotherapeutic Group of (API) Alpha-adrenoreceptor antagonists

For generic drugs (me-too status) Silon capsule by M/s Genix
Name and address of API manufacturer. Zhejiang Tianyu Pharmaceutical Co., Ltd, No. 15
Donghai 5th Avenue Zhejiang Provincial Chmeical
and Medical Raw Materials Base Linhai Zone
substance
dissolution profile established against the referenc eproduct of rapaflo
capsule
repeatability.
Zhejiang Tianyu Pharmaceutical Co., Ltd, No. 15 Donghai 5th Avenue

Manufacturer of API Zhejiang Provincial Chmeical and Medical Raw Materials Base Linhai Zone
API Lot No. Batch no. 13000-171201
Description of Pack Alu-Alu blister packed in unit carton (30’s)
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,1, 2, 3, 4 & 6 (months)
Sildos 4mg capsule
Batch No. 19SB-209-01 19SB-209-02 19SB-209-03
Batch Size 1500 1500 1500
Manufacturing Date 10.2019 10.2019 10.2019
Sildos 8mg capsule
Batch No. 19SB-212-01 19SB-213-02 19SB-214-03
Batch Size 1500 1500 1500
Manufacturing Date 10.2019 10.2019 10.2019
No. of Batches 06
Reference of previous approval of applications with --
a
The firm has submitted copy of GMP Certificate of
Approval of API/ DML/GMP certificate of API
M/s Zhejiang Tianyu Pharmaceutical Co., Ltd., issued
b manufacturer issued by concerned regulatory
by China Food and Drug Administration valid till 14-
03-2023
Firm has submitted copy of invoice specifying import
Documents for the procurement of API with of 0.1Kg silodosin dated 24.01.2018. The invoice is
c
approval from DRAP (in case of import). signed by AD (I&E) DRAP Karachi office on
06.02.2018..
Data of stability batches will be supported by Submitted
d attested respective documents like chromatograms,
Compliance Record of HPLC software 21CFR & Submitted

e
Record of Digital data logger for temperature and Submitted
f humidity monitoring of stability chambers (real
 The applied formulation to be manufactured by M/s Genix Pharma Private Limited 44-45B Korangi creek
Road Karachi have already been granted approval in 297th meeting of Registration Board. The case of the
applied formulation of M/s Genix Pharma Private Limited 44-45B Korangi Creek Road Karachi, was
considered and approved by Registration Board in its 297th meeting on Form 5D, based on the stabiltiy
data as per checklist for “Exemption from On-site inspection”. The details of the already considered
product in 297th meeting are as follows:
Applicant firm M/s Genix Pharma Private Limited 44-45B Korangi creek Road
Karachi
Manufacturer firm M/s Genix Pharma Private Limited 44-45B Korangi creek Road
Karachi
Brand Name Silpro 4mg capsule Silpro 8 mg capsule
Batch No. of drug product 19SB-209-01 19SB-209-02 19SB-212-01 19SB-213-02

19SB-209-03 19SB-214-03
Case No. 532 533
Registration Board meeting 297th meeting of Registration Board held on 12 -15 January, 2021
 Following data had been evaluated earlier in the above referred application of M/s Genix Pharma approved
in 289th meeting:
 Method used for analysis of API along with COA.
 Method used for analysis of FPP & complete record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets etc.)
 Record of comparative dissolution data against the reference product of Synjardy tablet.
 Complete batch manufacturing record of three stability batches.
 Reports of stability studies of API from manufacturer.
 Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
In addition to above referred data, which has also been evaluated in applicaton of M/s Genix pharma, the firm has
submitted following data also in compliance to the requirements of Form 5F:
 QOS.
 Pharmaceutical Equivalence studies.
 Process validation protocol.
 Analytical method validation studies for drug product.
 Analytical method verification studies for drug substance performed by the drug product manufacturer
shall be submitted.
Decision: Registration Board approved applications of Sildos 4mg Capsule & Sildos 8mg Capsule.
satisfactory capacity assessment of manufacturing and testing facility of M/s Genix Pharma Pvt Ltd.
44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan.
creek road Karachi
☐ Importer
☐ Export sale
general section
The proposed proprietary name / brand name Erglif-S 15/100 mg Tablet
Pharmaceutical ingredient (API) per unit Ertugliflozin L-Pyroglutamic Acid Eq. To
Ertugliflozin….…15mg
Sitagliptin Phosphate Monohydrate Eq. To
Sitagliptin…….100mg
Pharmacotherapeutic Group of (API) Anti Diabetic
For generic drugs (me-too status) --
Name and address of API manufacturer. Ertugliflozin: Shanghai Pharma Group Changzhou
kony Pharmaceuticals Co., Ltd China Daixi street,
Luoyang town, Wujin District, Changzhou, Jiangsu,
China
Sitagliptin: M/s Zheijiang Yengtai Pharmaceutical
Co., Ltd, China No1 Donghai 4th avenue zheijiang
provincial chemical and medical raw material base
Linhai zone, Linhai city Zhejiang province China
substance
tablet
repeatability.
creek road Karachi
☐ Importer
☐ Export sale
general section
The proposed proprietary name / brand name Erglif-S 5/100 mg Tablet
Pharmaceutical ingredient (API) per unit Ertugliflozin L-Pyroglutamic Acid Eq. To
Ertugliflozin….…5mg
Sitagliptin Phosphate Monohydrate Eq. To
Sitagliptin…….100mg
For generic drugs (me-too status) --
Name and address of API manufacturer. Ertugliflozin: Shanghai Pharma Group Changzhou
kony Pharmaceuticals Co., Ltd China Daixi street,
Luoyang town, Wujin District, Changzhou, Jiangsu,
China
Sitagliptin: M/s Zheijiang Yengtai Pharmaceutical
Co., Ltd, China No1 Donghai 4th avenue zheijiang
provincial chemical and medical raw material base
Linhai zone, Linhai city Zhejiang province China
substance
tablet
repeatability.
Ertugliflozin: Shanghai Pharma Group Changzhou kony Pharmaceuticals Co.,

Ltd China Daixi street, Luoyang town, Wujin District, Changzhou, Jiangsu,
China
Manufacturer of API
Sitagliptin: M/s Zheijiang Yengtai Pharmaceutical Co., Ltd, China No1
Donghai 4th avenue zheijiang provincial chemical and medical raw material
base Linhai zone, Linhai city Zhejiang province China
Ertugliflozin: ETG20180901
API Lot No.
Sitagliptin: 1827-0001-20015
Description of Pack Alu-Alu blister foil with unit carton
Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Real Time: 30°C ± 2°C / 65% ± 5%RH
Time Period Accelerated: 6 Months
Real Time: 6 Months
Frequency Real Time: 0,3 & 6 (months)
Accelerated: 0,1, 2, 3, 4 & 6 (months)
ERGLIF-S TABLET 5MG/100MG
Batch No. 20SB-004-01 20SB-005-02 20SB-006-03
ERGLIF -S TABLET 15MG/100MG
Batch No. 20SB-001-01 20SB-002-02 20SB-003-03
No. of Batches 06
a
Ertugliflozin: Firm has submitted copy of GMP
certificate (No. JS20170734) issued by CFDA China.
Approval of API/ DML/GMP certificate of API The certificate is valid till 25-12-2022.
b manufacturer issued by concerned regulatory Sitagliptin: The copy of cGMP Certificate valid up to
authority of country of origin. 28-06-2023 for M/s. Zheijang Yongtai
Pharmaceutical Co., Ltd., Zheijiang Province is
provided.
Ertugliflozin: Firm has submitted copy of
commercial invoice cleared dated 12-10-2018
specifying import of 500g Ertugliflozin. The invoice
is signed by AD (I&E) DRAP Karachi office dated
Documents for the procurement of API with 12-10-2018.
c Sitagliptin: Firm has submitted copy of
commercial invoice cleared dated 29-10-2019
specifying import of 300kg Sitagliptin phosphate
monohydrate. The invoice is signed by AD (I&E)
DRAP Karachi.
d attested respective documents like chromatograms,

e
f humidity monitoring of stability chambers (real
Road Karachi have already been granted approval IN 317th meeting of Registration Board. The case of the
applied formulation of M/s Genix Pharma Private Limited 44-45B Korangi Creek Road Karachi, was
considered and approved by Registration Board in its 317th meeting on Form 5D, based on the stabiltiy
data as per checklist for “Exemption from On-site inspection”. The details of the already considered
product in 317th meeting are as follows:
Karachi
Karachi
Brand Name ERTOZIN-S Tablet 5mg/100mg ERTOZIN-S Tablet 15mg/100mg
Batch No. of drug product 20SB-004-01 20SB-005-02 20SB-001-01 20SB-002-02

20SB-006-03 20SB-003-03
Case No. 11 12
Registration Board meeting 317th meeting of Registration Board held on 16 -17 May, 2022
in 289th meeting:
 QOS.
shall be submitted.
Decision: Registration Board approved applications of Erglif-S 15/100 mg Tablet & Erglif-S 5/100 mg
Tablet.
satisfactory capacity assessment of manufacturing and testing facility of M/s Genix Pharma Pvt
Ltd. 44,45-B, Korangi Creek Road, Karachi, 75190, Pakistan.
creek road Karachi
☐ Importer
☐ Export sale
general section
The proposed proprietary name / brand name Paglif-M XR 5/1000 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…….5mg (As Immediate Release
Coating)
Metformin HCl……1000mg (As Extended Release
Coating)
For generic drugs (me-too status) Emglif-M XR tablet by M/s Genix Pharma
Name and address of API manufacturer. Empagliflozin: Ruyuan HEC Co. Pharm. Co. Ltd.
Xiaba Development Zone, Ruyuan County,
Shaoguan City, Guangdong Province, China
Metformin hydrochloride: M/s Wanbury Ltd., India
substance
dissolution profile established against the referenc eproduct of Synjardy
tablet
repeatability.
Empagliflozin: M/s Ruyuan HEC Pharm Co., Ltd. China

Manufacturer of API Metformin HCl: M/s Wanbury Ltd., Dist. Raigad, Maharashtra State., India
Empagliflozin Lot #: EGLZ-RD20171101A

API Lot No.
Metformin Hydrochloride Lot #: MT00600118
Description of Pack
Alu-Alu Blister Pack
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5% RH
Accelerated: 40°C ± 2°C / 75% ± 5% RH
Real time: 6 months
Time Period
Accelerated: 0,1,2,3,4,6 (month)
Frequency
Real Time: 0,3,6 (month)
Batch No. 18SB-106-01 18SB-107-02 18SB-108-03
06-2018 06-2018 06-2018
Manufacturing Date
No. of Batches 03
a
Empagliflozin:
The DML # 20160622 valid till 2026 is provided for
Approval of API/ DML/GMP certificate of API RUYUAN HEC Pharm Co., Ltd
b manufacturer issued by concerned regulatory Metformin HCl:
authority of country of origin. Copy of GMP certificate issued by DCA Andhra
Pradesh valid upto 05-02-2022 for M/s Wanbury
Ltd.,West Godavari District, Andhra Pradesh, India
For Empagliflozin:
Copy of commercial Invoice declaring following
information on it:
Invoice No: WIS170152
Attested by: ADC Karachi
Attested on: 07-12-2017
Quantity: 0.75 Kg
From: M/s WIS Pharmatech Co., Ltd. Factory,
Documents for the procurement of API with approval Manufactured by M/s Ruyuan HEC Pharm Co., Ltd.
c
from DRAP (in case of import). China.
For Metformin HCl:
Copy of commercial Invoice declaring following
information on it:
Invoice No: EXP/92001577/ 17-18
Attested by: ADC Karachi
Attested on: 30-1-2018
Quantity: 5000 Kg
From: M/s Wanbury Limited, India.
Data of stability batches will be supported by attested Submitted
d respective documents like chromatograms,

e
fhumidity monitoring of stability chambers (real time
and accelerated)
Road Karachi have already been granted approval 19-10-2020. The case of the applied formulation of M/s
Genix Pharma Private Limited 44-45B Korangi Creek Road Karachi, was considered and approved by
Registration Board in its 293rd meeting on Form 5D, based on the stabiltiy data as per checklist for
“Exemption from On-site inspection”. The details of the already considered product in 293rd meeting are
as follows:
Karachi
Karachi
Brand Name Empag M 5mg + 1000mg XR Tablets
Batch No. of drug product 18SB-103-01 18SB-104-02 18SB-105-03
Case No. 2453
Registration Board meeting 293rd meeting of Registration Board held on 6 -8 January, 2020
in 289th meeting:
 QOS.
shall be submitted.
Decision: Approved.
creek road Karachi
☐ Importer
☐ Export sale
general section
The proposed proprietary name / brand name Paglif-M 12.5/1000 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…….12.5mg
Pharmacotherapeutic Group of (API) Anti-Diabetic
For generic drugs (me-too status) Emglif-M tablet by M/s Genix Pharma
substance
dissolution profile established against the reference product of Synjardy
tablet
repeatability.
Empagliflozin: EGLZ-RD20171101A
API Lot No. Metformin hydrochloride: MT00600118, MT00610118, MT00620118
MT00630118
Description of Pack
Real time: 30°C ± 2°C / 65% ± 5% RH
Stability Storage Condition
Real time: 6 months
Time Period
Frequency
Batch No. 18SB-103-01 18SB-103-02 18SB-103-03
No. of Batches 03
a
Empagliflozin:
Approval of API/ DML/GMP certificate of API Ruyuan HEC Pharm Co., Ltd
Empagliflozin:
Copy of Commercial Invoice signed & stamped by ADC
DRAP, Islamabad dated 07-12-2017 for the import of
Empagliflozin has been attached.
Batch No. Invoice No. Quantity

Documents for the procurement of API with approval Imported.
c
from DRAP (in case of import). EGLZ- WIS170152 750gm
RD20171101A
Metformin HCl:
Metformin HCl has been attached.

e
and accelerated)
Registration Board in its 289th meeting on Form 5D, based on the stabiltiy data as per checklist for
“Exemption from On-site inspection” of same batches of drug product as submitted in the instant case.
The details of the already considered product in 289th meeting are as follows:
Karachi
Karachi
Brand Name Empag-M Tablet 12.5mg/1000mg
Case No. 404
Registration Board meeting 289th meeting of Registration Board held on 14-16 May, 2019
in 289th meeting:
 QOS.
Analytical method verification studies for drug substance performed by the drug product manufacturer shall be
submitted.
Decision: Approved.
creek road Karachi
☐ Importer
☐ Export sale
general section
The proposed proprietary name / brand name Paglif-M 12.5/500 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin…….12.5mg
substance
tablet
repeatability.

MT00630118
Description of Pack
Real time : 30°C ± 2°C / 65% ± 5% RH
Real time: 6 months
Time Period
Frequency
Batch No. 18SB-100-01 18SB-101-02 18SB-102-03
No. of Batches 03
a
Empagliflozin:
Empagliflozin:

c
RD20171101A
Metformin HCl:


e
and accelerated)
Karachi
Karachi
Brand Name Empag-M Tablet 12.5mg/500mg
Case No. 403
in 289th meeting:
 QOS.
submitted.
Decision: Approved.
creek road Karachi
☐ Importer
☐ Export sale
general section
The proposed proprietary name / brand name Paglif-M 5/1000 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin….…5mg
Metformin HCl…….1000mg
substance
tablet
repeatability.

MT00630118
Description of Pack
Real time : 30°C ± 2°C / 65% ± 5% RH
Real time: 6 months
Time Period
Frequency
Batch No. 18SB-097-01 18SB-097-01 18SB-097-01
No. of Batches 03
a
Empagliflozin:
Empagliflozin:

c
RD20171101A
Metformin HCl:

e
and accelerated)
Karachi
Karachi
Brand Name Empag-M Tablet 5mg/1000mg
Case No. 405
in 289th meeting:
 QOS.
submitted.
Decision: Approved.
Name, address of Manufacturing site. M/s Genix Pharma Private Limited 44-45B Korangi creek
road Karachi
☐ Importer
☐ Export sale
Evidence of manufacturing facility Section approval letter declaring grant of Tablet general
section
The proposed proprietary name / brand name Paglif-M 5/500 mg Tablet
Pharmaceutical ingredient (API) per unit Empagliflozin….…5mg
Metformin HCl…….500mg
GMP status of the Finished product GMP granted on 07/10/2021
manufacturer
Name and address of API manufacturer. Empagliflozin: Ruyuan HEC Co. Pharm. Co. Ltd. Xiaba
Development Zone, Ruyuan County, Shaoguan City,
Guangdong Province, China
Summarized information related to nomenclature,
submitted.
controls, , specifications, analytical procedures and its
and stability studies of drug substance
tablet
Analytical method validation/verification of Method validation studies have been submitted including
product justification of system suitability, specificity, linearity,
accuracy, precision-repeatability.

API Lot No.
Metformin HCl: MT00600118
Description of Pack Alu-Alu blister foil with unit carton
Real Time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Frequency
Batch No. 18SB-093-01 18SB-095-02 18SB-096-03
No. of Batches 03
Reference of previous approval of applications --
a
Empagliflozin:
Copy of GMP certificate (2017029) issued by M/s
Shaoguan Food & Drug Administration, valid upto 21-01-
2019 for M/s Ruyuan HEC Pharm Co., Ltd.
b manufacturer issued by concerned regulatory
Metformin HCl:
Copy of GMP certificate issued by DCA Andhra Pradesh
valid upto 05-02-2022 for M/s Wanbury Ltd.,West
Godavari District, Andhra Pradesh, India
Empagliflozin:
Copy of Commercial Invoice signed & stamped by ADC DRAP,
Islamabad dated 07-12-2017 for the import of Empagliflozin has
been attached.

Documents for the procurement of API with Imported.
c
approval from DRAP (in case of import). EGLZ- WIS170152 750gm
RD20171101A
Metformin HCl:
Copy of Commercial Invoice signed & stamped by ADC DRAP,
Islamabad dated 30-01-2018 for the import of Metformin HCl
has been attached.
d
chromatograms,
Compliance Record of HPLC software 21CFR Submitted
e
& audit trail reports on product testing.
Record of Digital data logger for temperature Submitted
fand humidity monitoring of stability chambers
Karachi
Karachi
Brand Name Empag-M Tablet 5mg/500mg
Batch No. of drug product 18SB-093-01, 18SB-095-01, 18SB-096-01,
Case No. 406
in 289th meeting:
 QOS.
submitted.
Decision: Approved.
Name, address of Manufacturing site. M/s Genix Pharma Private Limited
44-45B Korangi creek road Karachi
☐ Importer
☐ Export sale
Evidence of manufacturing facility Section approval letter declaring grant of Beta-
Lactam (penem) section
The proposed proprietary name / brand name ERTAP 1gm Injection
Strength / concentration of drug of Active Each Vial contains:
Pharmaceutical ingredient (API) per unit Ertapenem sodium equivalent to Ertapenem
……………. 1gm
Pharmaceutical form of applied drug White to light yellow powder
Pharmacotherapeutic Group of (API) Anti-bacterial
The status in reference regulatory authorities Invanz Injection by Merck & CO.,INC ,
FDA Approved.
For generic drugs (me-too status) Ernem Injection by M/s Genix Pharma
Reg no: 081179
Capsule section approved.
Name and address of API manufacturer. SAVIOR LIFETEC CORPORATION, 29, Ke-
Jhong Rd., Chunan Chen, Miaoli, County 35053,
Taiwan, R.O.C.
substance
dissolution profile against the brand leader that is Invanz Injection
Analytical method validation/verification of product Method verification studies have been submitted
repeatability.
SAVIOR LIFETEC CORPORATION, 29, Ke-Jhong Rd., Chunan Chen,

Manufacturer of API Miaoli, County 35053, Taiwan, R.O.C.
API Lot No. 80S019AA001

Description of Pack
Glass vial
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 24 months
Time Period
Accelerated:0,3 & 6(Months)
Frequency
Real Time: 0,3, 6, 9 ,12,18 & 24 (Months)
Batch No. 001I042 002I042 003I042
No. of Batches 03
Reference of previous approval of applications with
a Not submitted
b manufacturer issued by concerned regulatory --
Copy of Purchase invoice No. S180201 attested
Documents for the procurement of API with approval
c by DRAP dated 06.06.2018 is submitted


e
f humidity monitoring of stability chambers (real time
and accelerated)
Section# Observation Firm’s response
1.6.5 Valid GMP certificate of drug substance Firm has submitted copy of GMP issued by
manufacturer shall be submitted. Ministry of Health & Welfare, Taiwan, valid
till 23/01/2024
3.2.S.5  Justification shall be submitted for We received working standard Ertapenem
using Ertapenem sodium lyophilized sodium as lyophilized powder from
powder as working standard insetad of supplier.
the pure Eertapenem sodium. Saviour Lifetech Corporation herenby
 Submitted drug substance analytical confirmed that ertapenem
procedure mandates use of Ertapenem sodiumlyophilized powder is more suitable
as working standard whereas as workingstandrad than Ertapneem sodium
submitted COA is of Ertapenem due to its longer retest period. 24 m. In thi
sodium lyophilized powder. scase, ertapaneme sodiumlyophilized
powder can be used in a more reliable way.
The actual assay can be calibrated by
method calculation. The ertapenem sodium
lyophilized powder is preferable as working
standard by our expert’s persepective.
Therefore, the submitted COA of Ertapneem
sodiumlyophilized powder was provide din
3.2.S.5.
3.2.S.7.3 Justification shall be submitted for As Ertapenem sodium lyophilized powder
conducting drug substance stability studies will b edirectly filled in to vial, the quality
at refrigerating conditions. of Ertapenem sodium lyophilized powder is
very critical and should be preserved in
conservative way at lower temperature.
Therefore based on this concept we chose to
conduct the stability studies of drug
substance in storage conditions of 5 +3oC to
ensure quality.
3.2.P.1  Justification shall be submitted for  The justification is as under:
proposed fill weight per vial of 1gmof Ertapenem for injection (Bulk
Eetapenem sodium considering the sterile) will contain following:
actual content of sodium declared in Ertapenem monosodium ….. 809.60mg
the drug substance analysis and Sodium bicarbonate …….. 135.40mg
content of sodium bicarbonate in the NaOH…….. 55.0mg
drug substance. Total……. 1000.0mg
 Details of accompanying Factor = Ertapenem sodium/Ertapneem
reconstitutuin diluent shall be = 497.50/475.5
submitted. = 1.046
Then,
1000.0mg x 1.046
1046.00mg appx. 1050mg.
The filled weight of 1340mg against the
determined potency of 78.20% of drug
substance eis justified as per above referred
calculations.
 Diluent is not the part of finished pack.

3.2.P.2.2.1  Submit justification of not performing Due to insufficient qanity of innovator
tests of pH, sterility, water content, sample, we performed appearance,
endotoxins and particulate matter in identification and Assay. As per
Pharmaceutical equivalence studies. requirements from DRAp, we performed all
test on new innovator sample “Invanz
injection”.
3.2.P.2.6  Comaptibility studies with the Submitted with 0.9% sodium chloride
reconstitution diluent shall be solution.
submitted.
3.2.P.5  Justification shall be submitted for not The material Ertapenemm sodium is
including tests of completeness and lyiophilized sterile powder and ready to fill
clarity of solution, pH, & water material, we performed these test during
content in the drug product API testing.
specifications, as recommended by the
Innovator product.
3.2.P.6  Justification shall be submitted for Same as above in section 3.2.S.6
using Ertapenem sodium lyophilized
powder as working standard insetad of
the pure Eertapenem sodium.
3.2.P.8  Justification shall be submitted for not  The material Ertapenemm sodium is
performing tests of completeness and lyiophilized sterile powder and ready to
clarity of solution, pH, & water fill material, we performed these test
content during stability studies. during API testing in order to reduce the
 Complete batch manufacturing record test on finished product testing and on
shall be submitted for the three basis of supplier stability studies of real
stability batches. time as well as accelerated. It is
 Microbial reports shall be submitted concluded that the API is stable
for the sterility testing during stability throghot the shelf life.
studies.  BMRs have been submitted.
 Documents confirming import of drug
substance with approval form DRAP
shall be submitted.
Decision: Deferred for scientific justification for:
 Use of Ertapenem sodium lyophilized powder as working standard insetad of the pure Eertapenem
sodium since submitted drug substance analytical procedure mandates use of Ertapenem as working
standard whereas submitted COA is of Ertapenem sodium lyophilized powder.
 Not including tests of ests of completeness and clarity of solution, pH, & water content in drug product
specifications and stability studies.
☐ Importer
☐ Export sale
Evidence of manufacturing facility GMP granted on 07/10/2021
Details of fee submitted Rs.75,000/- dated 15-11-2021 & Rs.75,000/- dated
16-08-2021
The proposed proprietary name / brand name Dexzole 30mg Capsule
Strength / concentration of drug of Active Each Delayed Release Capsule Contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole Delayed Release Pellets 22.5% Eq.
to Dexlansoprazole ……… 30mg
Pharmaceutical form of applied drug Round, Biconvex, Light Orange color, film coated
tablet, engraved “GENIX” on one side & break line
on other side.
Pharmacotherapeutic Group of (API) Proton pump inhibitor (PPI)
Reference to Finished product specifications Innovator Specification
The status in reference regulatory authorities By M/s Takeda Pharmaceuticals America, Inc ,
Dexilant Capsules 60mg (Delayed release Capsules)
USFDA Approved.
For generic drugs (me-too status) By M/s SAMI Pharmaceuticals (pvt.) Ltd.
Delanzo 60mg (Delayed release Capsules)
Name and address of API manufacturer. Alphamed Formulations Private Limited. (ready to fill
pellets)
Survey No.: 225, Sampanbole Village, Shamirpet
Mandal, Ranga Reddy District, Telangana – 500 078,
India
substance
dissolution profile against the brand leader that is Dexilant capsule
30mg M/s Takeda Pharmaceuticals America, Inc.
CDP is submitted.
repeatability.
M/s Alphamed Formulations Private Limited. Survey No.: 225, Sampanbole

Manufacturer of API Village, Shamirpet Mandal, Ranga Reddy District, Telangana – 500 078, India
API Lot No. ABC082021001/B
Description of Pack
Alu/alu blister
Real time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Accelerated:0,3 & 6(Months)
Frequency
Real Time: 0,3, 6, 9 ,12,18 & 24 (Months)
Batch No. 003C209 004C209 005C209
Batch Size 200,000 Capsule 200,000 Capsule 200,000 Capsule
No. of Batches 03
☐ Importer
☐ Export sale
Evidence of manufacturing facility GMP granted on 07/10/2021
16-08-2021
The proposed proprietary name / brand name Dexzole 60mg Capsule
Strength / concentration of drug of Active Each Delayed Release Capsule Contains:
Pharmaceutical ingredient (API) per unit Dexlansoprazole Delayed Release Pellets 22.5% Eq.
to Dexlansoprazole ……… 60mg
Pharmaceutical form of applied drug Round, Biconvex, Light Orange color, film coated
tablet, engraved “GENIX” on one side & break line
on other side.
Pharmacotherapeutic Group of (API) Proton pump inhibitor (PPI)
Reference to Finished product specifications Innovator Specification
The status in reference regulatory authorities By M/s Takeda Pharmaceuticals America, Inc ,
Dexilant Capsules 60mg (Delayed release Capsules)
USFDA Approved.
For generic drugs (me-too status) By M/s SAMI Pharmaceuticals (pvt.) Ltd.
Delanzo 60mg (Delayed release Capsules)
Name and address of API manufacturer. Alphamed Formulations Private Limited. (ready to fill
pellets)
Survey No.: 225, Sampanbole Village, Shamirpet
Mandal, Ranga Reddy District, Telangana – 500 078,
India
substance
dissolution profile against the brand leader that is Dexilant capsule
60mg M/s Takeda Pharmaceuticals America, Inc.
CDP is submitted.
repeatability.
M/s Alphamed Formulations Private Limited. Survey No.: 225, Sampanbole

Manufacturer of API Village, Shamirpet Mandal, Ranga Reddy District, Telangana – 500 078, India
API Lot No. ABC082021001/B

Description of Pack
Alu/alu blister
Real time: 30°C ± 2°C / 65% ± 5%RH
Time Period
Frequency Accelerated:0,3 & 6(Months)
Real Time: 0,3, 6, 9 ,12,18 & 24 (Months)
Batch No. 001C208 002C208 003C208
Batch Size 200,000 Capsule 200,000 Capsule 200,000 Capsule
No. of Batches 03
Reference of previous approval of applications with
a Not submitted
Approval of API/ DML/GMP certificate of API Copy of GMP certificate No. 3081/STORES/2019
b manufacturer issued by concerned regulatory issued by “Drug control administration Telangana” on
authority of country of origin. 30-08-2019 valid for 3 years
Documents for the procurement of API with approval Copy of Purchase invoice: GE035/2018 , attested by
c DRAP, dated 03/07/2018 is submitted

e
f humidity monitoring of stability chambers (real time
and accelerated)
Decision: Registration Board approved applications of Dexzole 30mg Capsule & Dexzole 60mg Capsule.
Firm shall submit differential fee for import of pellets for each strength.
1385. Name, address of Applicant / Marketing M/s Rogen Pharmaceuticals Plot No. 30, Street # S-4,
Authorization Holder National Industrial Zone, Rawat, Islamabad
Name, address of Manufacturing site. M/s Vision Pharmaceuticals Plot # 22,23, Industrial
Triangle, Kahuta Road, Islamabad
☐ Importer
☐ Export sale
Evidence of approval of manufacturing Firm has submitted copy of GMP certificate issued on basis
facility of inspection conducted on 11-02-2019, wherein Liquid
Ampoule general section is declared.
Details of fee submitted Rs.50,000/- dated 12-2021 & Rs.25,000/- dated 15-10-2021
The proposed proprietary name / brand name Rogvit-D Injection 5mg/ml
Pharmaceutical ingredient (API) per unit Cholecalciferol ……. 5mg
Pharmaceutical form of applied drug Liquid Injection
Route of administration IM
Reference to Finished product specifications In-House
The status in reference regulatory authorities Approved by ANSM of France.
For generic drugs (me-too status) Sunny D Injection of M/s Scotmann Pharma (Reg.#063450)
GMP status of the Finished product Firm has submitted copy of GMP certificate issued on basis
manufacturer of inspection conducted on 11-02-2019
Name and address of API manufacturer. M/s FERMENTA BIOTECH LIMITED, Village Takoli,
P.O. Nagwain, Dist. Mandi-175121, Himachal Pradesh,
India
manufacturers,
Characterization, specifications, analytical procedures and
and stability studies of drug substance. The firm has
summarized information of drug product including its
validation/verification 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 data for both drug substance
solubilities, physical form, manufacturers, 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 Firm has submitted stability study data of 3 batches of drug
substance at both accelerated as well as real time conditions.
The accelerated stability data is conducted at 25 O ± 2 O C
/60% ± 5% RH for 6 months. The real time stability data is
conducted at 5OC ± 3 O C.
Pharmaceutical equivalence and comparative Firm has performed pharmaceutical equivalence studies
dissolution profile against the Indrop-D injection.
Manufacturer of API M/s FERMENTA BIOTECH LIMITED, Village Takoli, P.O.

Nagwain, Dist. Mandi-175121, Himachal Pradesh, India
API Lot No. CLC0420149
Description of Pack
Amber glass ampoule
Frequency Accelerated: 0,1, 3, 6 (Months)
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 0118412 1218408 1218409
Batch Size 40,000 ampoules 50,000 ampoules 50,000 ampoules
No. of Batches 03
2. Approval of API/ DML/GMP certificate of GMP certificate (Certificate# 2062043) of M/s
API manufacturer issued by concerned FERMENTA BIOTECH LIMITED. Plot no. Z-109-B 7 C,
regulatory authority of country of origin. SEZ-II, DAHEJ, TAL-VAGRA, Dahej, dist. Bharuch,
Gujarat State, India issued BY Food 7 Drugs Control
Administration, Gujarat, India valid up to 17-06-2023.
approval from DRAP (in case of import). (invoice#RV2010020173) approved by AD DRAP I&E
Islamabad dated 11-11-2020 for the import of
Cholelcalciferol from M/s FERMENTA BIOTECH
LIMITED. Plot no. Z-109-B 7 C, SEZ-II, DAHEJ, TAL-
VAGRA, Dahej, dist. Bharuch, Gujarat State, India
4 Data of stability batches will be supported by --
5. Compliance Record of HPLC software 21CFR Not submitted
6. Record of Digital data logger for temperature Submitted.
(real time and accelerated).

1.1 Differential fee for Rs. 25,000/- shall be
submitted.
3.2.S.4.1 Copies of the Drug substance specifications and Submitted
Ingredient by Drug Product manufacturer is
required.
3.2.S.4.3 Analytical Method Verification studies Submitted.
including specificity, accuracy and repeatability
(method precision) performed by the Drug
Product manufacturer shall be submitted.
3.2.S.4.4 Provide results of analysis along with analytical Submitted
record, of relevant batch(es) of Drug Substance
performed by Drug Product manufacturer used
during product development and stability
studies, along with Certificate of Analysis (CoA)
of the same batch from Drug Substance / Active
Pharmaceutical Ingredient manufacture.
3.2.S.5 COA of primary / secondary reference standard Submitted
including source and lot number shall be
provided.
3.2.S.7 Evidence of availability of cold storage facility Calibration Certificate is attached for
in the raw material store shall be submitted, since evidence
the drug substance manufacturer has
recommended storage of API at 2- 8oC.
3.2.P.3.3 Submitted manufacturing procedure neither Firm has submitted BMRs declaring
includes step of terminal sterilization nor the steps of sterilization.
aseptic filtration prior to the ampoule filling.
Justification shall be submitted regarding how
the sterility of product is ensured.
3.2.P.4.1 Pharmacopoeial reference for the used excipient Submitted.
shall be submitted or else detailed specifications
and analytical procedure shall be submitted for
excipient used in the formulation.
3.2.P.5.1  Submitted drug product specifications does
not include test of “Uniformity of Dosage Firm has submitted revised
Units”. specifications.
 Justification shall be submitted for un- Previously we were adding
conventional Assay limits of “90% to overage/excess quantity in
120%”.
formulation and that was the reason
 Test of sterility does not refer to any
that we were giving the limit of 90-
particular or general limits.
 Submitted specification does not include
120% but currently we are not
test of sterility & endotoxin. adding any excess and also the limit
of BP for Cholecalciferol injection
7.5mg/ml which is 90-110% is
followed for 5mg/ml injection.
Revised SOP of product of Shine D
injection is attached here with.
For sterility testing we are
following the USP monograph
˂71˃.
Submitted Specifications already have
specs of sterility and Endotoxin
3.2. P.5.2  Detailed analytical procedures used for Submitted
testing the drug product shall be provided
3.2. P.5.3  Assay limits proposed in 3.2.P.5.1 are 90-
120%, whereas various parameters of Typographic mistake.
Analytical method validation have been In Linearity and range we had checked
performed with limit of90.0% - 110%. the sample even on 50% concentration,
 Accuracy parameter has not been performed which is below 100%, and this gives a
for concentration range below 100%. linear result.
In recent validation methods we had
incorporated checking at low
concentration for accuracy and
recovery below 100%, (i.e 80%), and
also at 120%.
Revised/Current Method validation is
submitted.
3.2. P.5.4 The copies of complete analysis reports of Submitted.
stability batches shall be provided.
3.2. P.5.6 The section declares that “Product is --
pharmacopoeial”. Evidence of monograph shall
be submitted for the claimed Pharmacopoeial
status of the product.
3.2.P.8.3  Submitted GMP certificate is of other drug API lot No: CLC0417053 is used for all
substance manufacturer than that declared of three stability batches.
in section 1.6.5 & 3.2.S.2.
 Submitted commercial invoice is of date
subsequent to the date of manufacturing of
stability batches.
 Submitted commercial invoice is from other
drug substance manufacturer than that
declared in section 1.6.5 & 3.2.S.2.
 Submitted COA of stability batches at all
time points of stability studies does not
include performance of tests of “Uniformity
Of Dosage Units”,
 Submitted Summary sheets of batch
#1218408 & 1218409 declare the use of API
lot# CLC0420149 for the manufacturing of
said batches, but as per submitted
commercial invoice the manufacturing date
of the said API Lot# CLC0420149 is
October 2020, which is subsequent to the
date of manufacturing of stability
batch#1218408 & 1218409.
Decision: Regsitration Board deferred the case for following:
 Documents attested by AD DRAP I&E, confirming import of relevant batch# of drug substance
used in the manufacturing of drug product stability batches.
 Drug product manufacturing and analytical record of recent commercial batch manufactured by
M/s Vision Pharmaceuticals.
 Registration status of the “Vitamin D3 injection” in name of M/s Vision pahrmaceuticals.
1386. Name, address of Applicant / Marketing M/s Rogen Pharmaceuticals Plot No 30, S-4,
Authorization Holder national industrial zone, Rawat, Islamabad,
Islamabad Capital, Territory
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd Plot No 204-
205, Industrial Triangle kahuta road Islamabad
☐ Importer
☐ Export sale
Details of fee submitted PKR 50,000/-: dated 16/04/2020 (#2031972)
PKR 25,000/-: dated 14/10/2021 (#41819350183)
The proposed proprietary name / brand name Mecorol 500mcg Injection
Strength / concentration of drug of Active Each ml Contains:
Pharmaceutical ingredient (API) per unit Mecobalamin …… 500mcg
Pharmaceutical form of applied drug Red color injectable solution filled in amber glass
ampoule.
Pharmacotherapeutic Group of (API) Vitamin B12
Reference to Finished product specifications Global Specification’s
Proposed Pack size 10x 1ml
The status in reference regulatory authorities Methycobal by M/s Eisai Co., Ltd. (Japan),
PMDA Approved.
For generic drugs (me-too status) Biocobal Injection 500mcg by Surge Laboratories,
Reg No: 033385
GMP status of the Finished product The firm is granted GMP certificate based on
manufacturer inspection conducted on 03-01-2022 and it is valid till
02-01-2024.
Name and address of API manufacturer. Hebei Yuxing Bio-Engineering Co. Ltd
High-tech Development Zone, Ningjin County China
system and stability studies of drug substance and drug
product is submitted.
substance
Batches: 7805016001, 7805016002 & 7805016001
product.
dissolution profile against the Methycobal Injection by performing
quality tests (Identification, Assay, Dissolution,
Uniformity of dosage form).
CDP is not available.
Manufacturer of API Hebei Yuxing Bio-Engineering Co. Ltd

High-tech Development Zone, Ningjin County China
API Lot No. M190522
Description of Pack
2 Alu-PVC blisters of 5 amber glass ampoules
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 19F015 19G352 19H018
Batch Size 90 Liters 90 Liters 90 Liters
No. of Batches 03
The firm has referred to previous inspection of stability data of
the same dosage form on the basis of which Registration Board
Reference of previous approval of in 289th meeting decided to approve registration of Promig Plus
500mg/20mg Tablet and Promig Plus 375mg/20mg Tablet.
1. applications with stability study Inspection date: 14th March, 2019
data of the firm The report shows that:
The HPLC software is 21 CFR compliant.
The firm has provided data loggers with stability chambers.
Approval of API/ DML/GMP Firm has submitted valid GMP Certificate No: HE2019-142 by
certificate of API manufacturer issued National Medical Products Administration China, valid till 29-
2. by concerned regulatory authority of 11-2024.
country of origin.
The firm has submitted copy of ADC (I&E) granted by DRAP
Documents for the procurement of API
dated on 09/07/2019, diary No: 1055.
3. with approval from DRAP (in case of
import).
Data of stability batches will be Submitted

4. documents like chromatograms, Raw
data sheets, COA, summary data
sheets etc.
Compliance Record of HPLC software Submitted
5. 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)
Sr.# Observations Firm’s response

3.2.S.5 COA of submitted working standard Coa of an old working standard was submitted
declares validity date as 02-09-2018, mistakenly. COA of working standard actually
whereas drug substance analysis has use din analysis is submitted now.
been performed subsequent to this
date, by M/s Global
3.2. P.1 Describe functional role of each Firm has submitted functional role of each
excipient used in formulation excipient used in the formulation , wherein
“Benzyl alcohol” has been declared as
preservative.
3.2. P.2.2.2 The justification statement “Overage To compnensate the machine variation and to
is added to adjust potency”, shall be overcome weigt losses in manufacturing
elaborated. process, overage was added.
3.2.P.5.1  Literature of the innovator product  As literature of innovator product was not
approved by PMDA of japan available at the time of product development,
declares the specifications for pH as pH of innovator product was determined by
5.3-7.3, whereas firm has proposed pH meter and set the pH of our product close
pH range of 5.0-7.0. Justification to innovator actual pH. Stability studies are
shall be submitted for this variation. around 6.6, which is wel within th elimits of
 Submitted specification does not Innovator given in literature. Limit of ph is
include test for “Antimicrobial now changed from 5.0 -7.0 to 5.3 – 7.3 in
effectiveness”, as recommended by specifications.
USP general chapter <51>. Justify  Test for antimicrobial effectiveness is
this disparity since proposed recommended for multi-dose sterile products
formulation contains “Benzyl to check the effectiveness of anti-microbial
Alcohol” as an antimicrobial agent. agent after opening of injection and storage
 Justify the unconventional limits of for second dose, our injection is single dose
90-125% for Assay test. solution.
 In drug product specifcations i.e., 90-125% is
a typographical mistake. Correct Assay
limits are 90-150%.
3.2.P.5.2  Justification shall be submitted for  JP does not contain mecobalamin injection
performance of Assay analysis by monograph. We have validated metghod on
“UV spectrophotometric method”, UV spectrophotometry and performed
whereas the JP monograph of testing. As the product is developed
mecobalamin has applied HPLC according to in-house specifications so
method. initially UV method was adopted for testing
 Different Assay limit between COA of drug product. The method was applied for
(90-150%) and 5.1 (90-125%) stability studies and later on method was
 changed to HPLC and stability studies of
other batches were carried according to
HPLC method.
 Firm has not submitted any data as per HPLC
method.
3.2.P.5.4 Submitted batch analysis COA specify  In drug product specifications 90-125% is a
different Assay limits i.e., 90-150% typographica;l mistake. Correct Assay limits
than those declared in drug product are 90 -150%.
specifications i.e., 90-125% submitted  Batch size of 90.0 ltrs is mentioned on
in section 3.2.P.5.1 stability data and summary sheets of each
 No batch size mention on COA batch.
 Two batches have Assay results  Assay limits are 90-15% as mentioned in
above 125% which is against stability summary sheets and COAs.
specifications submitted in section
3.2.P.5.1
3.2.P.5.6 This section declares details for It is a typographical mistake.
Ketorolac injection.
3.2.P.8  Different results for Assay test at  It is a typographical mistake, results
initial time point have been reported mentioned in stability summary sheets is
in stability summary sheet of batch# correct.
19F015 than those declared in COA
submitted in section 3.2.P.5.4.  19H018 contain significant change at 6th
 Significant change i.e., more than month assay and test has been performed as
5% in Assay results of accelerated per long term conditions i.e., 30°C ± 2°C /
stability studies for batch # 19H018 65% ± 5%RH that covers the additional
& 19G352 have been reported. requirement i..e, 30°C ± 2°C / 60% ± 5%RH
 Submitted invoice is subsequent to as per WHO guidelines. Result salso found
the manufacturing date of batch# within the specified limits i.e., 90-150%.
19F015
 Submitted BMR does not declare  Firm has submitted copy of License to import
the actual quantity dispensed for fro 5Kg Mecobalamin batch# M190522
formulation of batches. issued by AD I&E, Islamabad, dated 09-07-
 Justification shall be submitted for 2019.
performance of Assay analysis by
“UV spectrophotometric method”,  Firm has submitted copy of manufacturing
whereas the JP monograph of orders for stability batches wherein excess
mecobalamin has applied HPLC quantity of 28% for Mecobalamin has been
method. declared.
 JP does not contain mecobalamin injection

monograph. We have validated metghod on
UV spectrophotometry and performed
testing. As the product is developed
according to in-house specifications so
initially UV method was adopted for testing
of drug product. The method was applied for
stability studies and later on method was
changed to HPLC and stability studies of
other batches were carried according to
HPLC method.
Decision: Deferred for scientific justification of:
 Using excess quantity of 28% of drug substance in the formulation of submitted drug product
stability batches.
 Use of “Benzyl alcohol” as preservative since applied formulation is single dose injection.
 Performance of Assay analysis during drug product stability studies by “UV spectrophotometric
method”, whereas the JP monograph of Mecobalamin has applied HPLC method.
1387. Name, address of Applicant / Marketing M/s Rogen Pharmaceuticals Plot No 30, S-4,
Authorization Holder national industrial zone, Rawat, Islamabad,
Islamabad Capital, Territory
Name, address of Manufacturing site. M/s Global Pharmaceuticals (Pvt) Ltd Plot No 204-
205, Industrial Triangle kahuta road Islamabad
☐ Importer
☐ Export sale
07-05-2020
The proposed proprietary name / brand name Keto-R 30mg Injection
Strength / concentration of drug of Active Each ml Contains:
Pharmaceutical ingredient (API) per unit Ketorolac Tromethamine ….… 30mg
Pharmaceutical form of applied drug Red color injectable solution filled in amber glass
ampoule.
Pharmacotherapeutic Group of (API) Anti-inflammatory agent, non-steroid
Proposed Pack size 1ml×5’s
The status in reference regulatory authorities Ketorolac Tromethamine injection 30mg/ml by M/s
Peckforton Pharmaceuticals Limited Crewe Hall,
Crewe, Cheshire, CW1 6UL, United Kingdom,
MHRA Approved.
For generic drugs (me-too status) Toradol Injection 30mg/ml by M/s Barrett Hodgson
Pakistan (Pvt.) Ltd.
Reg. No. 015000
GMP status of the Finished product manufacturer The firm is granted GMP certificate based on
inspection conducted on 03-01-2022 and it is valid
till 02-01-2024.
Name and address of API manufacturer. M/s Saurav Chemicals Ltd., Unit-III, Village
Bhagwanpura, barwala Road, Dera basi, District
Ajitgarh (Mohali),Punjab, India.
process and controls, t, specifications, analytical
drug substance
Accelerated: 40°C ± 2°C / 75% ± 5%RH for 6
months
and justification of specification, reference
dissolution profile against the Toradol 30mg/ml Injection.
product including linearity, range, accuracy, precision,
specificity.
Manufacturer of API M/s Saurav Chemicals Ltd., Unit-III, Village Bhagwanpura,

barwala Road, Dera basi, District Ajitgarh (Mohali), Punjab, India.
API Lot No. KTM180018
Description of Pack
Alu-PVC blisters of glass ampoules
Real Time: 0, 3, 6, 9, 12, 18 & 24 (Months)
Batch No. 19C032 19A027 19D011
Batch Size 90 Liters 90 Liters 90 Liters
No. of Batches 03
The firm has referred to previous inspection of stability data
of the same dosage form on the basis of which Registration
Board in 289th meeting decided to approve registration of
Promig Plus 500mg/20mg Tablet and Promig Plus
Reference of previous approval of
375mg/20mg Tablet.
1. applications with stability study data Inspection date: 14th March, 2019
of the firm The report shows that:
chambers.
Approval of API/ DML/GMP Firm has submitted GMP Certificate No: 3124 from Food
certificate of API manufacturer issued & Drug Administration, Punjab valid till 24-06-2023.
2. by concerned regulatory authority of
country of origin.
The firm has submitted copy of ADC (I&E) granted by
Documents for the procurement of API
DRAP dated on 09/07/2019, diary No: 1055.
3. with approval from DRAP (in case of
import).
Data of stability batches will be Submitted

4. documents like chromatograms, Raw
data sheets, COA, summary data sheets
etc.
Compliance Record of HPLC software Submitted
5. 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)
Sr.# Observations Firm’s response

1.3.8-1.5.7 Relevant information has not been
submitted
2.3.R.1.1 Manufacturing process flow chart
submitted in the batch manufacturing
record declare the product as
terminally sterilized via Autoclave,
whereas no such step is mentioned in
the executed batch manufacturing
record. Clarification shall be submitted
whether applied product is terminally
sterilized or otherwise.
3.2.S.5 COA of submitted working standard
declares validity date as 29-05-2016,
whereas drug substance analysis has
been performed subsequent to this
date, by M/s Global.
3.2. P.1 Justify the proposed quantity of
30.9mg/ml of Ketorolac
tromethamine, declared in
composition table against the label
claim of 30mg/ml.
3.2.P.8  Submit following:
i. Documents for the procurement
of API with approval from
DRAP (in case of import).
ii. Analytical record for complete
stability studies including
chromatograms, raw data
sheets etc..
within six months.
1388. Name, address of Applicant / Marketing M/s Ahad International Pharmaceuticals Ltd
Authorization Holder Dera Ismail Khan
Name, address of Manufacturing site. M/s Ahad International Pharmaceuticals Ltd, 13
KM Gomal University Multan Road Dera Ismail
Khan
☐ Importer
☐ Export sale
Details of fee submitted PKR 30,000/-: vide deposit slip# 4953647152
The proposed proprietary name / brand name Parasafe Infusion 1gm/100ml
Strength / concentration of drug of Active Each 100ml infusion contains:
Pharmaceutical ingredient (API) per unit Paracetamol ……. 1gm
Pharmaceutical form of applied drug Solution for infusion
Pharmacotherapeutic Group of (API) Analgesic and Antipyretic
Reference to Finished product specifications In house specification
The status in reference regulatory authorities Paracetamol 10mg/ml solution for infusion (One
100ml vial contains 1000mg Acetaminophen) of
M/s Accord-UK Ltd approved by MHRA of UK
For generic drugs (me-too status) Provas Infusion 1Gm/100ml by Sami Pharma
GMP status of the Finished product Panel inspection report dated 09-07-2020 concludes
manufacturer satisfactory level of cGMP compliance.
Evidence of manufacturing facility Copy of panel inspection report dated 09-07-2020
has been submitted wherein availability of “Sterile
Vial Infusion” & “Ampoule” section has been
mentioned.
Name and address of API manufacturer. M/s Citi Pharma (Pvt) Ltd, 3KM Head Baloki
Road Phool Nagar District Qasur
Module-II (Quality3. Overall Summary) Firm has submitted QOS as per WHO QOS-PD
Module III (Drug Substance) Official monograph of Acetaminophen is present in
USP and BP. The firm as submitted detail of
tests for impurity D, G & related substances
(impurity A & unspecified), specifications,
months
impurities, specifications, analytical procedure and
its verification studies, batch analysis and
drug product.
Pharmaceutical equivalence Pharmaceutical Equivalence have been established
against the Provas infusion 1Gm/100ml by Sami
Pharma.
product including linearity, range, accuracy, precision,
specificty.
Manufacturer of API M/s Citi Pharma (Pvt) Ltd, 3KM Head Baloki Road Phool Nagar District
Qasur
API Lot No. PGP20-423, PARA/AWAS-001/20-001
Description of Pack
Glass vial
Frequency Accelerated: 0, 3,6 (Months)
Real Time: 0, 3, 6, 9, 12, 18, 24 (Months)
Batch No. 001 002 003
No. of Batches 03
1. Reference of previous approval of applications The firm has not submitted any document.
2. Approval of API/ DML/GMP certificate of Not Submitted
API manufacturer issued by concerned
3. Documents for the procurement of API with Not Submitted
4. Data of stability batches will be supported by Not Submitted
summary data sheets etc..
5. Compliance Record of HPLC software 21CFR N/A
6. Record of Digital data logger for temperature Not submitted

3.2.S.3.1 The said section declares M/s Hebei According to invoice Neon chemical is our indenter
Jiheng Pharmaceutical Co. Ltd as which deals both companies. Now we are performing
producer of Acetaminophen instead all the procedure according to Hebei Jiheng Pharma.
of M/s Citi Pharma.
3.2.S.4.2 Analytical procedure submitted by Drug substance manufacturer complies both BP & USP
Drug substance manufacturer is as specifications. Now we adopt analytical procedure
per USP monograph, whereas Drug according to USP specification.
product manufacturer has submitted
analytical procedure as per BP
monograph. Justification shall be
submitted for this variation.
3.2.S.4.3  Clarification shall be submitted  Analytical method verification studies have been
that whether submitted performed M/s Ahad International.
analytical method verification  Performed according ot USP monograph.
studies have been performed by
M/s Citi Pharma or M/s Ahad
International.
 Clarification shall be submitted
that whether submitted
analytical method verification
studies have been performed as
per USP or BP monograph.
3.2.S.4.4  COA of Paracetamol submitted  Firim has submitted COA of drug substance from
from M/s CITI Pharma declares M/s Hebei Jiheng Pharmaceutical Co. Ltd. China
it as “Analytical Working for batch# COS012012049 which also includes
Standard”, whereas results of sterility test.
analysis of relevant batch(es) of
Drug Substance performed by
Drug Product manufacturer
used during product
development and stability
studies, along with Certificate
of Analysis (CoA) of the same
batch from Drug Substance
manufacturer shall be
submitted.
 Submitted COA form M/s Citi
Pharma & M/s Ahad
International does not include
test of sterility. Clarification
shall be submitted in this
regard, since the drug substance
is to be used in the formulation
of a sterile product.
3.2.S.4.5 The said section declares that the Drug substance manufacturer complies both BP & USP
specifications adopted are as per the specifications. Now we adopt analytical procedure
monograph specified in USP while according to USP specification.
in section 3.2.S.4.2 analytical
procedure as per BP monograph has
been submitted.
3.2.P.3.5 Submitted process validation It is typographic mistake while the original strength is
protocol mentions the strength as 1000mg/100ml.
1000mg/10ml whereas applied
strength is 1000mg/100ml.
3.2.P.5.1 Justification shall be submitted for Actual pH range 5 – 7 for drug product according to
the proposed pH range of 4.0 -7.0 for USP specifications.
the drug product since the available
literature of the reference product
declares different pH range than that
proposed by the applicant.
3.2.P.5.3 Performance of Linearity parameter Submitted.
shall be submitted in Analytical
method validation studies.
3.2.P.5.4 The copies of complete analysis Firm has submitted copies of batch analysis reports fo
reports of all three trial batches shall all three stability bayches including results for sterility
be provided. testing and endotoxin.
Submitted analytical report of Trial-
01 does not include test of Sterility
& Endotoxin.
3.2.P.8  Submitted invoice from M/s  Firm has submitted copy of letter from M/s Neon
Neon Chemicals declare Chemicals, declaring submission of drug sample of
quantity of Paracetamol as of
50gm. Justification shall be 2Kg from M/s Hebei Jiheng Pharmaceutical Co.,
submitted for manufacturing of Ltd., China to M/s Ahad International.
three trial batches of 400vials  No document attested by AD I&E DRAP has been
each with 50gm of API. submitted in this regard.
 Submitted stability summary  Firm has submitted revised stability summary
sheets & reports declare sheets m conditions as per Zone Iva.
condition of real time stability  Firm has submitted revised analytical record along
studies as 25°C ± 2°C / 60% ± with chromatograms.
5%RH which is not as per Zone  Record of digital data logger has been submitted.
IVa.  GMP certificate eof the drug substance
 Submitted analytical record manufacturer has not been submitted.
shows that Assay calculations
for all three stability batches at
each time point of both
accelerated & long-term
stability studies have been
performed by applying same
value of Standard peak area.
Justification shall be submitted
in this regard.
 Record of data logger of
stability chambers shall be
submitted.
 Approval of API/ DML/GMP
certificate of API manufacturer
issued by concerned regulatory
authority of country of origin
shall be submitted.
Decision: Deferred for clarification regarding manufacturer of drug substance along with documents
confirming procurement of drug substance with approval of DRAP I&E office.
1389. Name, address of Applicant / Marketing M/s CCL Pharmaceuticals Limited. Plot No. 65,
Authorization Holder Quaid-e-Azam Industrial Estate, Kot Lakhpat,
Lahore, Punjab, Pakistan
Name, address of Manufacturing site. M/s Global Pharmaceuticals Pvt Ltd. Plot # 204-205,
☐ Importer
☐ Export sale
The proposed proprietary name / brand name Maxflow-S 0.4mg/6mg Tablet
Strength / concentration of drug of Active Each bilayer modified release tablet contains:
Pharmaceutical ingredient (API) per unit Solifenacin succinate…………….6mg
(Corresponding to 4.5mg of Solifenacin base)
Tamsulosin hydrochloride……….0.4mg
(Corresponding to 0.37mg of Tamsulosin base)
Pharmaceutical form of applied drug Film coated tablets.
Pharmacotherapeutic Group of (API) Antimuscarinics/Alpha-blockers
Reference to Finished product specifications Innovator
Proposed Pack size 5's, 10's, 14's, 20's, 28's, 30's, 50's and 100's
The status in reference regulatory authorities Vesomni Tablet by M/s Astellas Pharma Ltd., EMA
Approved.
For generic drugs (me-too status) Tamsolin -S by M/s Getz Pharma
GMP status of the Finished product Firm has submitted copy of GMP certificate dated 04-
manufacturer 01-2022.
Name and address of API manufacturer. M/s Alphamed Formulations Pvt. Ltd
Sy.No.225, Sampanbole Village Shamirpet Mandel,
Medchal-Malkajigiri District, Telangana-500 078,
India
Module III (Drug Substance) Official monograph of Solifenacin Succinate &
Tamsulosin HCl is not present in Pharmacopoeia. The
firm as submitted detail of nomenclature, structure,
and controls, tests for impurities, specifications,
months
Tamsulosin HCL Batches:
(8000173-039(A), 8000173-045(A), 8000173-
046(A))
Solifenacin Succinate Batches:
(8000173-039(B), 8000173-045(B), 8000173-
046(B))
product.
dissolution profile against the innovator Vesomni Tablet by M/s Astellas
Pharma Ltd, UK by performing quality tests
(Identification, Assay, Dissolution, Uniformity of
dosage form).
is Vesomni Tablet by M/s Astellas Pharma Ltd, UK
in Acid media & Phosphate Buffer. The values for f1
and f2 are in the acceptable range.
Analytical method validation/verification of Method validation studies have submitted including
Manufacturer of API M/s Alphamed Formulations Pvt. Ltd.

Sy.No.225, Sampanbole Village Shamirpet Mandel, Medchal-
Malkajigiri District, Telangana-500 078, India
API Lot No. Tamsulosin HCl: 8000173-041(A)
Solifenacin Succinate: 8000173-041(B)
Description of Pack
Batch No. T5-01 T5-02 T5-03
No. of Batches 03
2. Approval of API/ DML/GMP certificate of API Copy of GMP certificate valid till 30/08/2022.
3. Documents for the procurement of API with  Copy of Invoice, Diary No. 2142 dated 04/08/2017
approval from DRAP (in case of import). is submitted wherein the permission to import API
Tamsulosin HCl and Solifenacin Succinate is
granted.
 Invoice No. 034/2017-18 attested by AD I&E
dated 04-08-2017.
chromatograms,
Remarks of Evaluator(Ammar):
Subsequently firm has submitted stability studies data of 2 commercial batches along with full fee of Rs.
75,000/- vide deposit slip# 986205168101. Details of the commercial batches data is as under:
Manufacturer of API M/s Alphamed Formulations Pvt. Ltd.

Sy.No.225, Sampanbole Village Shamirpet Mandel, Medchal-Malkajigiri
District, Telangana-500 078, India
API Lot No. Tamsulosin HCl: AT0018-002
Solifenacin Succinate: AT0019-003
Description of Pack
Batch No. 21L133 21M294 --
Batch Size 110,000 tab 110,000 tab --
Manufacturing Date 11-2021 12-2021 --
Date of Initiation 29-12-2021 20-01-2022 --
No. of Batches 03
2. Approval of API/ DML/GMP certificate of Copy of GMP certificate valid till 30/08/2022.
API manufacturer issued by concerned

chromatograms,
etc.
Pharmaceutical equivalence and CDP Studies data in three dissolution mediums of pH 1.2, 4.5 & 6.8 has
been submitted against the Tamsolin-S tablet pf M/s Getz Pharma

3.2.S.4  Submitted drug substance  With reference to the control of drug
(Tamsulosin specifications of Tamsulosine substance, API manufacturer has tested the
HCl) granules does not include test of dissolution against the RLD Vesomni, but
dissolution hence it’s not did not include the test in release
evident that the Tamsulosine specifications. Moreover, FPP
granules are modified release or Manufacturer has included the Dissolution
otherwise. Justification shall be Testing of Tamsulosin Granules at finished
submitted in this regard. product stage, that shows the granules
 Submitted COA from both drug release is modified.
substance and drug product  Dissolution testing is not included in the
manufacturer does not declare release specification. However, modified
the Tamsulosine granules as release of tamsulosin granules is declared in
“modified release”. the label claim of the Finished Product.
 Justification shall be submitted  Dissolution profile of the granules
for using Tamsulosine granules established at FPP stage as evident from the
0.178% w/w% for drug product Product testing Method and CDP.
formulation without
establishing its dissolution
profile.
3.2.P.1  Submitted label claim does not Label claim of the tablet is as follow:
elaborate the immediate release Each bilayer modified release tablet contains:
& modified release layer of the Solifenacin succinate… 6mg
dosage form. (Corresponding to 4.5mg of Solifenacin base)
(Immediate release layer)
Tamsulosin hydrochloride….0.4mg
(Corresponding to 0.37mg of Tamsulosin base)
(Modified release layer)
3.2.P.2.2.1  Justification shall be submitted For Tamsulosin in CDP, release NLT 80%
for performing CDP studies till achieved in 12hours therefore next time point
12 hours’ time point only, was not included in consideration.
whereas the drug product
specifications mention the last
time point as of 16hrs.
3.2.P.5  Justification shall be submitted According to USP General Chapter <1092>,
for applying speed of 100rpm Please consider the following,
with USP Apparatus II in the “100 rpm may be used with Apparatus 2,
dissolution test with reference especially for extended-release products.
to the provisions of USP Decreasing or increasing the apparatus
general chapter <1092>. rotation speed may be justified if to achieve an
in vitro–in vivo correlation (IVIVC) the
resulting profiles better reflect in vivo
performance, or if the method results in better
discrimination without adversely affecting
method variability.”
3.2.P.8.3  Documents confirming import Copy of letter issued by AD I& E DRAP
of drug substance used for Islamabad, dated 28-10-2021, permitting import
formulation of stability batches, of Solifenacin 6% granules (25Kg) &
attested by DRAP, shall be Tamsulosin HCl 0.178% granules (50 Kg)
submitted.
 Submitted BMRs does not  Mg. stearate in Section 3.2.P.1 is
reflect the dispensing of approximately 2% of the formulation which
Magnesium stearate, whereas is used to increase the flow properties of
the composition submitted in granules only if required and that would be
section 3.2.P.1 includes of Pharmacopeial Grade (BP), if used.
magnesium stearate. Therefore, submitted BMR does not
 Dispensed quantity of includes the Mg. Stearate.
Tamsulosine HCl granules &  Potency determined during the Analysis of
Solifenacin granules, shall be both the drug substance is more than 100%,
justified against the potency that’s why Potency is considered equivalent
determined during drug to 100% while dispensing of Drug
substance analysis. substance.
 Justification for claiming “Tamsulosine HCl granules” as modified relase since no such declaration
has been maned in drug substance specifications and COA.
 Scientific justification from drug substance emanufcaturer for not including test of “Dissolution” in
the specifications of “Tamsulocin HCl granules” for establishing the modified release profile.
 Scientific justification from drug product manufacturer for not establishing dissolution profile of
“Tamsulosine HCl granules” vide performance of dissolution test before using them as in the drug
product formulation.
 Capacity assessment of manufacturing and testing facility of M/s Global Pharmaceuticals Pvt Ltd.
Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad
1390. Name, address of Applicant / “M/s Ray Pharma Pvt. Ltd, S-58, S.I.T.E Karachi, Pakistan.”
Marketing Authorization Holder
Name, address of Manufacturing site. “M/s Ray Pharma Pvt. Ltd, S-58, S.I.T.E Karachi, Pakistan.”
Status of the applicant ☒Manufacturer
☐ Importer
☐ Export sale
The proposed proprietary name / brand WFI Injection 5ml
name
Strength / concentration of drug of Active Each Ampoule Contains:
Pharmaceutical ingredient (API) per unit Sterile Water for Injection…….….5ml
Pharmaceutical form of applied drug Liquid Injection
Pharmacotherapeutic Group of (API) Solvent
Reference to Finished product USP

specifications
Proposed Pack size 1’s (5ml) x 100 ampoules per pack
Proposed unit price Rs. 5.75 Per Ampoule
The status in reference regulatory Approved by US FDA

authorities
For generic drugs (me-too status) Water for Injection of M/s Martin Dow
GMP status GMP certificate issued on basis of inspection conducted on 05-

07-2022
Name and address of API manufacturer. NA
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, , analytical
procedures, batch analysis and justification of specification,
reference standard, and stability studies of drug substance and
drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance data related
to nomenclature, structure, general properties, solubilities,
physical form, manufacturers, description of manufacturing
process and controls, specifications, analytical procedures
standard, container closure system and stability studies of drug
substance.
Stability Studies of Drug Substance NA
(Conditions & duration of Stability
studies)
process validation protocols, , 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 Pharmaceutical Equivalence studies have been performed
against the WFI of M/s Martin Dow
Analytical method validation/verification N/A
of product
Stability studies Firm has submitted stability studies data of three batches at
both accelerated and long-term conditions
Manufacturer of API NA
API Lot No. NA
Description of Pack
(Container closure Type I Glass ampoule
system)
Stability Storage 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 PD021 PD022 PD023
Sr.# Documents To Be Provided Status
1. Reference of previous approval of
firm (if any).
2. Approval of API by regulatory authority of Not applicable
country of origin or GMP certificate of API
manufacturer issued by regulatory authority
of country of origin.
3. Documents confirming import of API etc. Not applicable

4. Data of stability batches will be supported
Yes
by attested respective documents like
5.
Compliance Record of HPLC software
21CFR & audit trail reports on product Not applicable
testing
6.
Record of Digital data logger for
Yes
accelerated)
REMARKS OF EVALUATOR
Observations Firm’s response
3.2.S.4 You have submitted finished product Firm has submitted specifications and analytical
specifications, COA, analytical method etc. instead method for drug substance.
of providing drug substance information.
Justify why the test for nitrates, sulphates, We follow the USP specifications and as per USP
Aluminium and ammonium are not performed 43 official monograp/ water 4653 we performed
during stability studies. (appearance, pH, Conductivity, Total Orgainc
Carbon, Bacterial Endotoxin tests) thereof tests of
nitrates, sulphates, aluminum and ammonium are
not mentioned in USP specifications.
Decision: Approved.
1391. Name, address of Applicant / Marketing M/s Parkar Pharma. Plot No. O/7-A, S.I.T.E Area
Authorization Holder Kotri, Sindh
Name, address of Manufacturing site. M/s Inventor Pharma. Plot No. K/196, S.I.T.E. (SHW)
Phase II, Karachi
☐ Importer
GMP status of the firm (manufcaturer) GMP certificate issued on 13-08-2020.
Evidence of approval of manufacturing Firm has submitted copy of GMP certificate of M/s Neutro
facility Pharma, declaring the availability of Injectable general
section.
☐ Export sale
The proposed proprietary name / brand Parmol 1000mg/100ml Infusion
name
Strength / concentration of drug of Active Each 100ml vial contains:
Pharmaceutical ingredient (API) per unit Paracetamol ……. 1000mg
Pharmaceutical form of applied drug Parenteral (Injectable)
Pharmacotherapeutic Group of (API) Analgesic/Antipyretic
Reference to Finished product Manufacturer’s Spec
specifications
Proposed Pack size 1’s x 100ml
Proposed unit price As per DRAP policy.
The status in reference regulatory Approved by MHRA of UK
authorities
For generic drugs (me-too status) Falgan infusion of M/s Bosch
Name and address of API manufacturer. ANHUI BBCA LIKANG PHARMACEUTICAL CO.,
LTD
Address: No 6288 Donghai Road, Bengube city, Anhui
province, China
and its validation, batch analysis and justification of
and stability studies of drug substance and drug product.
Module-III Drug Substance: Firm has submitted detailed data for drug substance data
related to nomenclature, structure, general properties,
batch analysis and stability studies of drug substance.
Stability Studies of Drug Substance Stability study conditions:
(Conditions duration of Stability studies) Real time: 30°C ± 2°C / 65% ± 5%RH for 48 months
Pharmaceutical Equivalence and Pharmaceutical Equivalence have been established against
Comparative Dissolution Profile the brand leader that is BOFALGAN 1g/100ml Solution
for infusion by BOSH PHARMACEUTICALS (PVT)
LTD
by performing quality tests (Identification, Assay,
sterility & volume variation
N/A
Stability studies Firm has submitted stability studies data of three batches at
both accelerated and long-term conditions.
Anhui BBCA Likang Pharmaceutical CO., LTD
Manufacturer of APIs Address: No 6288 Donghai Road, Bengube city, Anhui province, China
API Lot No.

202002047A
Description of Pack Type III 100 ml glass vial pack in unit carton is used
(Container closure system) as primary packaging (1 x1 vial)
Real time: 30°C ± 2°C / 65% ± 5%RH
Real time: 6 months
Time Period
Accelerated: 0, 3, 6 (Months)
Frequency
Batch No. PI-001 PI-001 PI-001
Sr.# Documents To Be Provided Status
1. Reference of previous approval of
applications with stability study data of Not submitted
the firm (if any)
2. Approval of API/ DML/GMP certificate --
of API manufacturer issued by concerned
3. Documents for the procurement of API --
import).
4. Data of stability batches will be supported
Firm has submitted data of stability batches along with batch
by attested respective documents like
manufacturing record and analytical record.
5. Compliance Record of HPLC software
21CFR & audit trail reports on product Not submitted.
testing.
6. Record of Digital data logger for
temperature & humidity monitoring of
Submitted
accelerated)
Section Observation Firm’s response

1.6.5 Approval of API/ DML/GMP certificate of API
authority of country of origin shall be submitted.
3.2.S.4  Analytical Method Verification studies
including specificity, accuracy and repeatability
(method precision) performed by the Drug
Product manufacturer shall be submitted.
3.2.P.8.3  Documents confirming procurement of drug  Copy of commercial invoice no.

substance shall be submitted. 20NVT-090 attestedby AD
 Complete batch manufacturing record of DRAP I&E Karachi dated 27-03-
stability batches shall be submitted. 2020 forimport of 1000 Kg of
Paracteamol in name of M/s
Inventor.
Decision: Deferred for submission of following:
 Approval of API/ DML/GMP certificate of API manufacturer issued by concerned regulatory authority of
country of origin.
 Analytical Method Verification studies including specificity, accuracy and repeatability (method precision)
performed by the Drug Product manufacturer shall be submitted.
 Complete batch manufacturing record of stability batches.
1392. Name, address of Applicant / Marketing M/s Standard Drug Company. E-6A, S.I.T.E
Authorization Holder Hyderabad
Name, address of Manufacturing site. M/s Inventor Pharma. Plot No. K/196, S.I.T.E. (SHW)
Phase II, Karachi
☐ Importer
GMP status of the firm (manufcaturer) GMP certificate issued on 13-08-2020.
Evidence of approval of manufacturing Firm has submitted copy of GMP certificate of M/s Neutro
facility Pharma, declaring the availability of Injectable general
section.
☐ Export sale
Details of fee submitted

Minutes of 323 Meeting of Registration Board Held On 6 To8 December, 2022

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Minutes of 323 Meeting of Registration Board Held On 6 To8 December, 2022

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MINUTES OF 323rd MEETING OF REGISTRATION BOARD

HELD ON 6th to 8th December, 2022

Item No. Detail of Item Pages

II. Division of Biological Evaluation & Research -------------- 2474-2638

III. Division of Quality Assurance & Laboratory Testing ------- 2639-2643

Drug Regulatory Authority of Pakistan

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 1

Following members attended the meeting:

2. Lt. Gen.(R) Prof. Dr. Karamat A. Karamat (HI-M.SI-M), Former Member

5. Mr. Hafeez ur Rehman, DTL, Rawalpindi Member

6. Dr. Imranullah Khan, Director, DTL, Peshawar Member

8. Mr. Ajmal Sohail Asif, Director, Division of QA&LT Member

9. Mrs. Muneeza Khan, Representative of Division of MD&MC Member

10. Mr. Ghulam Mujtaba, Deputy Director, Representative of IPO Member

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 2

Pharmaceutical Evaluation Cell (PEC)

Sr. No Name of Evaluator Title

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 3

Item No. XIII: Agenda of Evaluator-X

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 5

Decision: Referred to Expert working Group to review therapeutic requirement keeping in

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 9

Brand Name +Dosage Form + Respolex Oral Powder

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 10

Brand Name +Dosage Form + Micotil Oral Liquid 250mg/ml

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 11

Brand Name +Dosage Form + Broncolex Oral Liquid 50mg/ml

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 12

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 13

Brand Name +Dosage Form + Neolex-P Oral Powder 72gm

Brand Name +Dosage Form + Tybrox Oral Liquid

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 14

Brand Name +Dosage Form + Lexi-Dox Oral Powder 500mg

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 15

Brand Name +Dosage Form + Aro Mox Powder 200mg/10,00,000IU

Brand Name +Dosage Form + D-20 Powder

Decision: Approved upto pack size of 1Kg.

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 17

Brand Name +Dosage Form + Fendox Liquid 20gm/10gm/8gm/20gm

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 18

Brand Name +Dosage Form + M-10 Powder

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 19

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 21

Decision: Approved with innovator’s specifications.

Brand Name +Dosage Form + Bromofloxin Oral Liquid

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 23

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 24

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 25

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 27

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 29

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 30

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 32

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 33

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 34

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 35

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 36

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 37

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 40

VITAMIN D3 BP….. 1,000 IU (25mcg)

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 42

Bio-Mycin 11% Premix Powder of M/s Bio-Labs (Pvt) Ltd,

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 44

Minutes of 323rd meeting of Registration Board (6th to 8th December, 2022) 45