Minutes for 273rd Meeting Registration Board held...

Minutes for 273rd

Registration Board Meeting 1

Minutes for 273rd

Meeting Registration Board held on 28-29th

August, 2017.

Item No. Detail of Item Page No.

Item No.I Confirmation for minutes of 272nd

Registration Board meeting 03

Item No.II Pharmacy Services Division 04 05

Item No.III Pharmaceutical Evaluation & Registration Division 06 665

Item No.IV Biological Evaluation & RegistrationDivision 666 762

Item No.V Quality Assurance & Lab Testing Division 763 770

Item No.VI Additional Agenda

A. Pharmaceutical Evaluation & Registration Division

B. Biological Evaluation & Registration Division

771 777

778 781

Minutes for 273rd


273rd

meeting of Registration Board was held on 28-29th

August, 2017 in the

Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting

was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &

Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The

meeting was attended by the following: -

1. Dr. Rafeeq Alam Khan Meritorious Professor, Faculty of Pharmacy,

University of Karachi

Member

2. Maj.Gen.Dr. Tahir Mukhtar Syed Commandant AFIRM / Head Department of Medicine, Army

Medical College

Member

3. Prof.Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah Women University, Karachi

Member

4. Dr. Qurban Ali, Ex-Director General National Veterinary Laboratory, Islamabad.

Expert Member Vetrinary Drugs

Member

5. Dr.Aslam Shah Senior Manager, Pharmacy and Purchase,

Indus Hospital, Karachi

Member

6. Dr. Amanullah Khan Director, Drugs Testing Laboratory, Quetta

Government of Baluchistan

Member

7. Dr. Muhammad Shoaib Akhter Director, Drugs Testing Laboratory, Rawalpindi

Government of Punjab.

Member

8. Mr. Abid Hayat, Director, Drugs Testing Laboratory, Peshawar,

Govt. of Khyber Pakhtunkhwa

Member

9. Mr. Muhammad Aslam Assistant Draftsman-II, Ministry of Law & Justice

Member

10. Mr.Ghulam Mujtaba Representative IPO

Member

11. Dr. Shaikh Akhter Hussain Director, Medical Device Division, DRAP

Director, QA&LT Division, DRAP

Member

12. Dr. Noor-us-Saba Director, Biological Evaluation & Registration Division, DRAP

Member

13. Dr.Obaidullah, Additional Director (PE&R) Secretary

The officers of relevant sections assisted their Directors with agenda and deliberation

during the meeting.

Mr.Shamim Ahmad, Mr.Khalid Muneer, Mr.Nadeem Hussain Alamgeer, Mr.Abdul

Samad and Mr.Shahzad Hussain attended the meeting as observer on behalf of PPMA,

Pharma Bureau and PCDA respectively.

Minutes for 273rd


Item No. I: Confirmation of minutes of 272nd

meeting Registration Board.

272nd

meeting of Registration Board was held on 27-28th

July, 2017. The draft

minutes were circulated among the members of meeting on 12.08.2017 with the request to

forward their comments (if any) but no comments were received by members of Registration

Board. However, during scrutiny of draft minutes, Assistant Director (R.I) identified a

correction as recorded in last column of the following table;

Details Name of firm, product

&composition

Recorded

Decision

Correct Decision

Case No.08:

Registration of

Veterinary Drugs.

a. Routine applications of

List-II.

Sr.No.665

M/s Epoch Pharmaceuticals, Karachi

N Sulfon Injection

Each ml contains:-

Novaminsulfon BP.40.0mg

Etileftine (as HC1) BP0.2mg

Calcium Gluconate USP.100.0mg

Magnesium Gluconate USP..10.0mg

Sodium Salicylate BP.7.0mg

Nicotinamide BP0.30mg

Caffeine USP.10.0mg

Boric A USP..10.0mg

Approved Deferred as the

product containing

Novaminsulfon

(Metamizole);

which is a banned

drug.

Draft minutes were approved by Chairman, Registration Board with above correction.

Submitted for information of Registration Board.

Decision: Registration Board confirmed the minutes as approved by Chairman,

Registration Board.

Minutes for 273rd


Item No. II: Pharmacy Services Division.

Case No.01: Change of Principal Investigator at already approved trial site - An

International Randomised, Double Blind Placebo Controlled Trial

(HALT IT Trial)

The subject cited Clinical Trial was approved by Drug Registration Board in its

253rd

meeting held on 05th

& 06th

October, 2015. The details of the trial are as under;

Title: Tranexamic Acid for the Treatment of Gastrointestinal

Haemorrhage: an International Randomized, Double Blind Placebo

Controlled Trial

Trial Acronym HALT-IT (Haemorrhage Alleviation With Tranexamic Acid

Intestinal System)

Brief Summary

Severe bleeding in the digestive system is a common symptom of

many diseases. Each year, about 50,000 people end up in British

hospitals because of this problem and about 5,000 of them die. The

most common cause of this bleeding is stomach ulcers. In sub-

Saharan Africa, schistosomiasis (parasitic worms) is responsible for

about 130,000 deaths from stomach bleeding each year. From

previous research in other bleeding conditions such as surgery and

trauma, we know that a drug called Tranexamic acid can reduce

bleeding and save lives. We now want to do the HALT-IT trial to see

if giving Tranexamic acid can save lives and if there are any

complications in people with severe bleeding from the digestive

system.

Trial Design

Allocation: Randomized

Intervention Model: Parallel

Assignment Masking: Double blind

Primary Purpose: Treatment

Medical Condition Gastrointestinal Bleeding

Trial Phase Phase III

Investigational Product Tranexamic Acid

Control No. 3-4/2015DD (PS)

Approval Date 08th December, 2015 vide 253

rd DRB dated 05

th& 06

th October, 2015

Duration of Trial 18 Months (Approx.)

Status Recruiting

Target Enrollment 8000

Total numbers of participants

recruited till now

7104

Participants recruited in

Pakistan

1112

Eligibility Criteria

Inclusion Criteria:

adult patients

with acute significant upper or lower gastrointestinal

bleeding

Where the responsible clinician is substantially uncertain as

to the appropriateness of anti-fibrinolytic agents in the

patient.

Exclusion Criteria:

The fundamental eligibility criterion is the responsible

clinician's 'uncertainty' as to whether or not to use an

antifibrinolytic agent in a particular patient with upper or

lower gastrointestinal bleeding.

Sex/Gender All

Minutes for 273rd


Age Group 16 Years and older (Child, Adult, Senior)

Approved Study Sites in

Pakistan

Holy Family Hospital, Rawalpindi

Shifa International Hospital, Islamabad

Lady Reading Hospital, Peshawar

DHQ Hospital, Narowal

DHQ Hospital, Khuzdar

DHQ Hospital, Rawalpindi

Benazir Bhutto Hospital, Rawalpindi

Jinnah Hospital, Lahore

Liaquat National Hospital, Karachi

POF Hospital, Wah Cantt.

Services Hospital, Lahore

Shaukat Khanum Memorial Hospital, Lahore

Mardan Medical Complex, Mardan

Madinah Hospital, Faisalabad

Aziz Bhatti Shaheed Hospital, Gujrat

DHQ Hospital, Faisalabad

Hayatabad Medical Complex, Peshawar

Mayo Hospital, Lahore

Sir Ganga Ram Hospital, Lahore

Allied Hospital, Faisalabad

Asian Institute of Medical Sciences, Hyderabad

DHQ Hospital, Sargodha

Bolan Medical Complex, Quetta

Jinnah Postgraduate Medical Center, Karachi

Participating Countries More than 40 countries including Pakistan

Sponsor London School of Hygiene & Tropical Medicine, London, UK

Chief Investigator Prof. Ian G Roberts

Trial Coordinator in Pakistan Prof. Muttiullah Khan (Holy Family Hospital, Rawalpindi)

In 256th

meeting dated 03rd February, 2016 the Registration Board granted approval of

08 additional trial sites including Medicine Unit I, Jinnah Hospital, Lahore along with its

Principal Investigator Prof. Zafar Iqbal Chaudhary.

The trial management has informed that Prof. Zafar Iqbal Chaudhary has retired and

can no longer continue as Principal Investigator at above mentioned site and Dr. Khalid

Mahmood Nasir is taking over his duties.

The applicant has requested for approval of above mentioned change of Principal

Investigator at the said trial site. The applicant has also submitted the CV of the new

Principal Investigator along with ethical approval of concerned Institutional Review Board

(IRB).

Decision: In the light of discussion and deliberations, Registration Boardapproved

the change of Principal Investigator from Prof. Zafar Iqbal Chaudhary to

Dr. Khalid Mahmood Nasir at previously approved trial site i.e Medicine

Unit I, Jinnah Hospital, Lahore

Minutes for 273rd


Item No. III: Pharmaceutical Evaluation & Registration Division.

A. Pharmaceutical Evaluation Cell.

S.No. Detail

Case No.01 Cases wherein correction is required in previous minutes of Registration Board

Case No.02 Routine Application

a) Routine applications for registration of (Human) drugs submitted with full fee

i. New cases

ii. Deferred cases

iii. Cases in which the firms have yet not been responded even after lapse of 30 days

iv. Cases in which the firms have been communicated for short-comings with 30 days time period and waiting for reply

v. Cases in which the firms have been responded with incomplete replies

b) Routine applications whose differential fee submitted upto 30th September, 2015

i. New cases

ii. Deferred cases

Case No.03 Registration applications of newly granted DML or New section

a) DML (Drug Manufacturing License(s))

b) Deferred Cases of newly granted DML

c) New section(s)

d) Deferred cases of New section(s)

Case No.04 Registration of veterinary drugs

a) Deferred cases of previous meetings

b) Applications for Registration of drugs whose replies are still awaited

Case No.05 Applications for registration of drugs for which stability studies are required

a) New cases of stability studies for consideration

b) Deferred cases of stability studies

c) Verification of stability data

Case No. 06 Cases of personal hearing

Case No. 07

Miscellaneous Cases

a) Innovators Formulation of Dexlansoprazole

b) Consideration of applications on priority basis

Case No. 08 Applications to be considered on priority

Minutes for 273rd


Sr. No Name of Evaluator Title

1. Mr. Muhammad Tahir Waqas Evaluator PEC-I

2. Mr. Ammar Ashraf Awan Evaluator PEC-II

3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III

4. Mst. Urooj Fatima Evaluator PEC-IV

5. Mst. Iqra Aftab Evaluator PEC-V

6. Mr. Muhammad Umar Latif Evaluator PEC-VI

7. Mst. Sidra Khalid Evaluator PEC-VII

8. Mst. Haleema Sharif Evaluator PEC-VIII

9. Mr. Farooq Aslam Evaluator PEC-X

10. Mst. Najia Saleem Evaluator PEC-XI

11. Syed Ajwad Bukhari Evaluator PEC-XII

12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

13. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Minutes for 273rd


Case No.01: M/s Hudson Pharma (Pvt) Ltd., Karachi

Registration Board in its 272nd

meeting approved the following product considering it

as me-too/generic drug as the applied drug contains the same molecule with different

packaging material and the firm submitted the stability studies.

Sr.

No.

Name &

Address of

Manufacturer

/ Applicant

Brand Name

(Proprietary Name +

Dosage Form + Strength),

Composition,

Pharmacological Group,

Finished Product

Specification

Type of Form,

Initial Diary &

Date, Fee

(including

differential fee),

Demanded Price

/ Pack size

International

Availability /

Local

Availability

GMP

Inspection

Report Date

& Remarks

Previous DRB

Decision / Remarks

(if any)

1. M/s Hudson Pharma (Pvt)

Ltd.,

Karachi.

ROLAC Injection 30mg

Each PE Ampoule

contains:

Ketorolac Trometamol

.....30mg

(NSAIDS)

USP Specs

Form 5

Diary No. 1489

26/07/2016

Rs. 20,000/-

As per SRO / 5s

PE Ampoules

(1ml)

Toradol by

Roche

Pharmaceutical,

USA.

Tromit by

Standpharm

Ltd.

Last

inspection

report dated

02.05.2016

confirms

Good GMP

compliance.

Remarks 264th

Meeting:

Toradol by Roche

Pharmaceutical is

discontinued in USA.

Tromit by M/s.

Standpharm is

available as ampoules,

amber type I glass.

Decision 264th RB

Meeting:

Deferred for

submission of stability

data.

STABILITY STUDY DATA

Drug ROLAC Injection 30mg (Ketorolac Trometamol)

Name of Manufacturer M/s Hudson Pharma (Pvt) Ltd., Karachi.

Manufacturer of API Dr. Reddys Laboratory Ltd., India.

API Lot No. ABJH007546

Description of Pack

(Container closure system) PE Ampoule.

Stability Storage Condition Real Time: 30C 2C / 65% 5%RH

Accelerated:40C 2C / 75% 5%RH

Time Period Real Time: 06 Months

Accelerated: 06 Months

Frequency Real Time:0,1,3,6 (Months)

Accelerated: 0,1,3,6 (Months)

Batch No. 001 002 003

Batch Size 20,000 Ampoules 20,000 Ampoules 20,000 Ampoules

Manufacturing Date 07-12-2016 08-12-2016 09-12-2016

Date of Initiation 13-12-2016 13-12-2016 13-12-2016

No. of Batches 03

Date of Submission 20-07-2017 (Dy. No. 3333)

Minutes for 273rd


DOCUMENTS / DATA PROVIDED BY THE APPLICANT

Sr.

No. Documents To Be Provided Status

1. COA of API Yes

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.

Copy of GMP certificate issued by

Drugs Control Administration

(Telangana), India is submitted.

3. Protocols followed for conduction of stability study and

details of tests. Yes

4. Data of 03 batches will be supported by attested

respective documents like chromatograms, laboratory

reports, data sheets etc.

Yes

5. Documents confirming import of API etc. Copy of permission to import API

issued by ADC (Karachi) is submitted.

6. All provided documents will be attested (name, sign and

stamp) for ensuring authenticity of data / documents. Yes

7. Commitment to continue real time stability study till

assigned shelf life of the product. Yes

8. Commitment to follow Drug Specification Rules, 1978. Yes

REMARKS OF EVALUATOR

The firm has submitted 06 Months Accelerated and 06 Months Real Time Stability Study Data for 03 Batches.

Evidence of differential fee of Rs. 30,000/- & Form 5-D are not submitted.

Significant Change (5.26%) was observed between initial (100.47%) and 1st Month (95.21%) Assay Results for Real Time Stability Study of Ketorolac (Batch No. 002).

Significant Change (6.17%) was observed between initial (100.47%) and 3rd Month (94.3%) Assay Results for Accelerated Stability Study of Ketorolac (Batch No. 002).

Stability completion date is mentioned as 14-06-2017.

But erroneously, the decision was recorded as under:

Decision: Registration Board deliberated that difference in packaging material is not

considered as me-too/Generic. So, no need to be applied on Form 5D and such

applications shall be treated as Me-too/Generic. The Assay results are within

specified limits (90%-110%). Registration Board therefore, approved the

above product.

The correction in decision is as under:

Decision: Registration Board deliberated that difference in packaging material is

not considered as New Drug. So, no need to be applied on Form 5D and

such applications shall be treated as Me-too/Generic. The Assay results

are within specified limits (90% - 110%). Registration Board, therefore,

approved the above product.

Minutes for 273rd


Case No.02 Routine Applications

a) Routine applications for registration of (Human) drugs submitted with full fee i. New cases

ii. Deferred cases iii. Cases the firms have yet not been responded even after lapse of 30 days iv. Cases the firms have been responded with incomplete replies v. Cases the firms have been communicated for short-comings

b) Routine applications whose differential fee submitted upto 30th September, 2015 i. New cases

ii. Deferred cases

1. New cases Evaluator PEC-II

2. Name and address of manufacturer / Applicant

M/s Asian Continental Pvt. Ltd. D-133, Tipu sultan road,

KDA scheme-1, Karachi.

Brand Name +Dosage Form + Strength Morex 4 mg tablet

Composition Each tablet contains:

Tizanidine (as hydrochloride) . 4 mg

Diary No. Date of R& I & fee Dy. No.23; 03-07-2015; Rs.20,000/- (02-07-2015)

Pharmacological Group Centrally acting -adrenergic agonist

Type of Form Form-5

Finished product Specification USP

Pack size & Demanded Price 10s; As per PRC

Approval status of product in Reference

Regulatory Authorities.

Approved by USFDA

Me-too status Movax 4mg Tablets of M/s Sami Pharmaceutical, Karachi

(Reg.# 042139)

GMP status Last GMP Inspection of Asian Continental Conducted on

28-12-16 with conclusive remarks of Good level of cGMP

compliance.

Remarks of the Evaluator.

Decision:Approved with change of brand name


M/s Asian Continental Pvt. Ltd. D-133, Tipu sultan road,

KDA scheme-1, Karachi.

Brand Name +Dosage Form + Strength Morex 2 mg tablet


Tizanidine (as hydrochloride) . 2 mg


Pharmacological Group Centrally acting -adrenergic agonist

Type of Form Form-5


Pack size & Demanded Price 10s; As per PRC



Approved by USFDA

Me-too status Movax 2mg Tablets of M/s Sami Pharmaceutical, Karachi

(Reg.# 025594)

GMP status Last GMP Inspection of Asian Continental Conducted on

28-12-16 with conclusive remarks of Good level of cGMP

compliance.


Decision:Approved with change of Brand name

Minutes for 273rd



M/s Curatech Pharma (Pvt.) Ltd., Multan Road, Lahore.

Brand Name +Dosage Form + Strength Myset tablet 4 mg

Composition Each film coated tablet contains:

Ondansetron (as hydrochloride) . 4mg


Pharmacological Group Antiemetic

Type of Form Form-5

Finished product Specification BP

Pack size & Demanded Price 3 x 10s: As per SRO



USFDA approved

Me-too status Oniron 4mg Tablets of M/s Genome Pharmaceuticals (Pvt,)

Ltd, (Reg.#068374)

GMP status Last inspection conducted on 14-01-2016 declaring the

GMP compliance at satisfactory level.

Remarks of the Evaluator. Latest inspection report conducted within one year shall be submitted.

Decision:Deferred for submission of latest GMP inspection report conducted within a period of

last one year by DRAP.


M/s OBS Pakistan (Pvt) Limited Karachi

Brand Name +Dosage Form + Strength Ursodol 250 mg capsules

Composition Each capsule contains:

Ursodeoxycholic acid.250 mg


Pharmacological Group Anticholilethic

Type of Form Form-5


Pack size & Demanded Price 10s ; Rs.550/



Approved by MHRA of UK

Me-too status Urso 250mg Capsule of M/s AGP (Reg#015677)

GMP status Last inspection conducted on 11-04-2017 and report

concludes that firm is found to be operating with GMP

compliance.

Remarks of the Evaluator. Firm has stated following alternate brand names: i. Ursolic ii. Ursob

Decision:Approved.

6. Name &address of

manufacturer/Applicant

M/s OBS Pakistan (Pvt) Limited Karachi

Brand Name +Dosage Form + Strength Ursodol 500 mg capsules





Type of Form Form-5


Pack size & Demanded Price 10s ; Rs.1100/



Approved by Sweden

Me-too status Urso 500mg Capsule of M/s AGP (Reg#070853)


concludes that firm is found to be operating with GMP

Minutes for 273rd


compliance.

Remarks of the Evaluator. Firm has stated following alternate brand names: i. Ursolic ii. Ursob

Decision:Approved

7. Name and address of manufacturer /

Applicant

M/s OBS Pakistan (Pvt) Ltd Karachi contract

manufacturing by M/s AGP (Pvt) Ltd,B-23,S.I.T.E,

Karachi

Brand Name +Dosage Form + Strength Ursodol 250mg/5ml suspension

Composition Each 5 ml contains:




Type of Form Form-5


Pack size & Demanded Price 120ml ; Rs.950/



Approved by MHRA of UK.

Me-too status Urso suspension of M/s AGP (Reg#076152)

GMP status Last inspection of M/s AGP (Pvt.) Ltd. conducted on

06.09.2016 and report concludes that firm is found to be

operating with GMP compliance.

Remarks of the Evaluator. Firm has submitted No objection certificate from M/s AGP (Pvt.) ltd.

Copy of Third party agreement between M/s OBS Pakistan (Pvt) Limited Karachi & M/s AGP (Private)

Limited, B-23, S.I.T.E, Karachi, valid upto 24.6.2018

has been submitted.

A detail of already approved products for contract manufacturing in the name of OBS is required.

Decision:Approved


Applicant

M/s. Atco Laboratories Ltd. B-18, S.I.T.E., Karachi

Brand Name +Dosage Form + Strength Xorav tablet 15 mg

Composition Each film coated contains:

Rivaroxaban.15mg


Pharmacological Group Anti-thrombic agent

Type of Form Form-5

Finished product Specification Innovators specifications

Pack size & Demanded Price Per tablet; Rs.1200/-

2s; Rs.2,400/-; 5s; Rs.6000/-; 7s; Rs.8400/-

10s; Rs.12000/-; 14s; Rs.16,800/-; 20s; Rs.24,000/-

28s; Rs.33,600/-; 30s; Rs.36,000/-




Me-too status Xarelto of M/s Bayer Health Care (Reg.# 072549)


concludes that firm is found to be operating at good level

of GMP compliance.

Remarks of the Evaluator. No monograph is available in USP & BP for applied formulation.

Firm has claimed Innovators specifications.

Decision:Approved with Innovators specifications.

Minutes for 273rd



Applicant

M/s. Atco Laboratories Ltd. B-18, S.I.T.E., Karachi

Brand Name +Dosage Form + Strength Xorav tablet 20 mg

Composition Each film coated contains:

Rivaroxaban.20 mg


Pharmacological Group Anti-thrombic agent

Type of Form Form-5

Finished product Specification Innovators specifications

Pack size & Demanded Price Per tablet; Rs.1600/-

2s; Rs.3,200/-; 5s; Rs.8,000/-; 7s; Rs.11,200/-

10s; Rs.16,000/-; 14s; Rs.22,400/-; 20s; Rs.32,000/-

28s; Rs.44,800/-; 30s; Rs.48,000/-




Me-too status Xarelto of M/s Bayer Health Care (Reg.# 072550)


concludes that firm is found to be operating at good level

of GMP compliance.

Remarks of the Evaluator. No monograph is available in USP & BP for applied formulation.

Firm has claimed Innovators specifications.



M/s. NOA Hemis Pharmaceuticals, Plot No 154,Sector 23,

Korangi Industrial Area, Karachi

Brand Name +Dosage Form + Strength Xifexin Tablet


Venlafaxine (as hydrochloride).. 37.5mg


Pharmacological Group Antidepressant

Type of Form Form 5


Pack size & Demanded Price 14s, 28s; As per SRO.




Me-too status V-Fax 37.5 mg Tablets by M/s Sayyed Pharmaceuticals

(Pvt) Ltd (Reg#070373)


concludes that firm is operating at acceptable of GMP

compliance.


Decision:Approved

Minutes for 273rd



Applicant

M/s. Irza Pharmaceutical, Lahore

Brand Name +Dosage Form + Strength Irzadol Injection

Composition Each 2ml ampoule contains:

Tramadol hydrochloride100mg


Pharmacological Group Synthetic, Centrally Active, Analgesic

Type of Form Form 5

Finished product Specification Manufacturer specifications

Pack size & Demanded Price 5s; As fixed by the MOHs competent authority




Me-too status Tremomed 100mg injection by M/s Medicraft

Pharmaceuticals (Pvt.) Ltd. (Reg#064484)

GMP status Last inspection conducted on 12-05-2017 recommending

the renewal of DML.

Remarks of the Evaluator. Firm has claimed manufacturers specifications.

No official monograph is available for applied formulation in USP or BP.



Applicant


Brand Name +Dosage Form + Strength Lopres 25mg Tablets


Metroprolol Tartrate25mg


Pharmacological Group Selective beta-adrenoreceptor blocking agent

Type of Form Form 5


Pack size & Demanded Price 3 x 10s; As fixed by the MOHs competent authority



Approved by health Canada

Me-too status Merol 25mg tablet by M/s Atco labs. (Reg#030905)


the renewal of DML.


Decision:Approved. 13. Name and address of manufacturer /

Applicant


Brand Name +Dosage Form + Strength Lopres 50mg Tablets


Metroprolol Tartrate50mg


Pharmacological Group Selective beta-adrenoreceptor blocking agent

Type of Form Form 5


Pack size & Demanded Price 3 x 10s; As fixed by the MOHs competent authority



Approved by health Canada

Me-too status Merol 25mg tablet by M/s Atco labs. (Reg#030905)


the renewal of DML.


Decision:Approved

Minutes for 273rd


14. Name and address of manufacturer / Applicant M/s Innvotek Pharmaceuticals Islamabad

Brand Name +Dosage Form + Strength Ketlur Eyes Drops 5ml

Composition Each ml contains

Ketorolac tromethamine..5mg


Pharmacological Group NSAID

Type of Form Form 5


Pack size & Demanded Price 1s x 5ml; Rs. 125/-




Me-too status Kats Sterile Ophthalmic Solution by M/s Medicaids

(Pak) Ltd, Karachi (Reg#058072)

GMP status According to last inspection report dated 09-03-2017

the company is complying with the GMP guidelines.

Remarks of the Evaluator. Firm has submitted one page accelerated stability study report without stating batch number.

The manufacturing date stated on submitted stability report is of 2013 whereas application has

been filed on 24-02-2016.

Upon communication of above observations vide letter No. F.1-1/2017/PEC-DRAP (AD PEC-II)

firm had replied as under;

It is a me-too drug and we dont have the API

for trial batches. It is just a specimen how we

record the accelerated stability studies. 2013 is a

typographic mistake, please consider it as 2016.

We will submit detail accelerated stability studies

of three batches before marketing the drugs.

Firm has claimed manufacturers specifications.




Brand Name +Dosage Form + Strength Blephnil eye drops 5ml

Composition Each ml contains:

Sulphacetamide sodium .100mg

Prednisolone acetate ..2mg


Pharmacological Group Antibacterial / Corticosteriod

Type of Form Form 5


Pack size & Demanded Price 1s x 5 ml; Rs. 160/-



Approved by USFDA

Me-too status Not verifiable



Remarks of the Evaluator. Me too products available for applied combination contain prednisolone acetate 0.25%, whereas firm has

applied with prednisolone 0.2% which is as per

reference product approved by USFDA.

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.

Minutes for 273rd



Brand Name +Dosage Form + Strength Oflex 0.3% Eyes Drops 5ml


Ofloxacin 3.00mg


Pharmacological Group Anti-bacterial

Type of Form Form 5


Pack size & Demanded Price 1s; Rs. 100/-




Me-too status Floxamed Ophthalmic Solution by M/s Medicaids

(Pak) Ltd, Karachi (Reg#058063)



Remarks of the Evaluator. Firm has submitted one page accelerated stability study report without stating batch number.

The manufacturing date stated on submitted stability report is of 2013 whereas application has

been filed on 24-02-2016.

Upon communication of above observations vide letter No. F.1-1/2017/PEC-DRAP (AD PEC-II)

firm had replied as under;

It is a me-too drug and we dont have the API

for trial batches. It is just a specimen how we

record the accelerated stability studies. 2013 is a

typographic mistake, please consider it as 2016.

We will submit detail accelerated stability studies

of three batches before marketing the drugs.

Decision:Approved


Brand Name +Dosage Form + Strength Combilol Eyes Drops 5ml


Brimonidine tartrate .2mg

Timolol (as maleate).5mg


Pharmacological Group Anti glaucoma

A2- andrenergic agonist/ Beta -blocker

Type of Form Form 5






Me-too status Timbro Eye Drops by M/s Searle IV Solutions (Pvt.)

Ltd (Reg#078626)





Decision:Approved with Innovators specification.

Minutes for 273rd



Brand Name +Dosage Form + Strength Latim 0.005% Eyes Drops 2.5ml


Latanoprost50mcg


Pharmacological Group Prostaglandin F2a analogue

Type of Form Form 5


Pack size & Demanded Price 1s x 2.5 ml; Rs. 600/-



Approved by USFDA

Me-too status Lotoros Drops by M/s Bosch-II Karachi.

(Reg#070603)







Brand Name +Dosage Form + Strength Bimat 0.03% eye Drops 3ml


Bimatoprost.0.3mg


Pharmacological Group Prostaglandin analog

Type of Form Form 5





Approved by USFDA

Me-too status Lumigan Eye Drops by M/s Barrett Hodgson

Pakistan (Pvt) Ltd., Karachi. (Reg#033177)






20. Name and address of manufacturer / Applicant M/s. Genome Pharmaceuticals, Hattar

Brand Name +Dosage Form + Strength Anabrec 1mg Tablets


Anastrozole1mg


Pharmacological Group Selective non-steroidal aromatase inhibitor of

antineoplastic therapeutic class.

Type of Form Form 5


Pack size & Demanded Price 2 x 14s; As recommended by PRC




Me-too status Aremed 1 Flim Coated Tablet of M/s High-Q

International Karachi. ((Reg.#062297).

Minutes for 273rd


GMP status Panel inspection conducted on 14-01-2017 and report

concludes that firm is following the GMP guidelines.


Decision:Approved in the light of decision made in 271st meeting of registreation Board wherein

Board decided to grant registration of these products in general manufacturing areas with

condition that manufacturer shall provide safety and protective measures for workers and

personnel which remain in direct contact or are involved in close handling of these drugs.

21. Name and address of manufacturer / Applicant M/s. Nenza Pharmaceuticals, Peshawar

Brand Name +Dosage Form + Strength Nenxime 200mg Dry Suspension

Composition Each 5ml contains:

Cefixime (as trihydrate)...200mg


Pharmacological Group Cephalosporin.

Type of Form Form 5


Pack size & Demanded Price 1s x 30ml; As per SRO



Approved by USFDA

Me-too status Refspan Suspension 200mg of M/s Rasco Pharma

(Reg.# 038950)

GMP status Last inspection report conducted on 31-03-2017

concluding satisfactory level of GMP compliance.


Decision:Approved.

22. Name and address of manufacturer / Applicant M/s GT Pharma Pvt Ltd. Lahore

Brand Name +Dosage Form + Strength Myoprin SR-15mg Capsule


Cyclobenzaprine hydrochloride 22%w/w sustained

release pellets eq. to Cyclobenzaprine 15mg

Source of pellets: M/s Vision Pharmaceuticals,

Islamabad.


Pharmacological Group Muscle relaxants and cholinesterase inhibitors

Type of Form Form 5


Pack size & Demanded Price 14s; As per SRO.



Approved by USFDA

Me-too status Mezrel XR 15mg Capsule by M/s Pharmevo Karach

(Reg#070800)


recommends the grant of DML.

Remarks of the Evaluator. Last inspection report conducted within last one year by DRAP shall be submitted.

Decision:Deferred for submission of latest GMP inspection report conducted within a period of

last one year by DRAP.

23. Name and address of manufacturer / Applicant M/s Benson Pharmaceutidcals Islamabad

Brand Name +Dosage Form + Strength Zithro 250mg Tablets

Composition Each tablet contains:-

Azithromycin as dihydrate250mg

Diary No. Date of R& I & fee Dy.No.4424; 13-07-2015; Rs.20,000/- (08-07-2015)

Pharmacological Group Antibacterial

Type of Form Form-5


Minutes for 273rd


Pack size & Demanded Price As per SRO




Me-too status Aziomak Tablets 250 mg by M/s. Makson

Pharmaceuticals. (Reg. No. 070015)

GMP status Last inspection conducted on 04-08-2017 stating

satisfactory level of GMP.

Remarks of the Evaluator. Firm has propose following alternate brand names:

i. Benzith 250mg tablets ii. Benthro 250mg tablets

Decision:Approved.

24. Name and address of manufacturer / Applicant M/s Benson Pharmaceutidcals Islamabad

Brand Name +Dosage Form + Strength Zithro 500mg Tablets


Azithromycin as dihydrate500mg

Diary No. Date of R& I & fee Dy.# 4425; 13-07-2015; Rs.20,000/- (08-07-2015)


Type of Form Form-5


Pack size & Demanded Price As per SRO




Me-too status Biozith Tablets by M/s. Bio Labs (Pvt) Ltd, (Reg.

No. 069912)


satisfactory level of GMP.

Remarks of the Evaluator. Firm has propose following alternate brand names:

i. Benzith 500mg tablets ii. Benthro 500mg tablets

Decision:Approved

25. Name and address of manufacturer / Applicant M/s. Wnsfeild Pharmaceuticals, Hattar

Brand Name +Dosage Form + Strength Alestra Tablets


Amlodipine (as besylate)..5mg

Valsartan160mg

Diary No. Date of R& I & fee Dy. No. 57; 02-03-2016; Rs.20,000/- (02-03-2016)

Pharmacological Group Calcium antagonist/angiotension II receptor antagonist

Type of Form Form-5


Pack size & Demanded Price As fixed by Government




Me-too status Amvazam Tablets by M/s. Cirin Pharmaceuticals.

(Reg. No. 060814)


GMP compliance status.


Decision:Approved

Minutes for 273rd



M/s. Wnsfeild Pharmaceuticals, Hattar

Brand Name +Dosage Form + Strength Linzowin 100ml Infusion


Linezolid.2mg


Pharmacological Group Oxazolidinones

Type of Form Form-5

Finished product Specification Manufacturer specifications.

Pack size & Demanded Price As fixed by Government



Approved by USFDA

Me-too status Lizotek Infusion 2mg /ml by M/s. Tabros Pharma (Pvt)

Ltd, Karachi (Reg. No. 057940)

GMP status Last inspection conducted on 23-11-2016 stating GMP

compliance status.

Remarks of the Evaluator. Firm has submitted one page stability data without mentioning any details of the batch and also relevant

documents have not been submitted.

When clarification was soughed from firm regarding above observation vide letter no. F.1-1/2017/PEC-

DRAP (AD PEC-II) firm had replied as under:

We have attached a wrong stability document in

dossier of our product Linzowin 100ml infusion. We

assure you that we will follow the procedure of

stability submission as per decision taken in DRB 251st

meeting and in this regard we have also submitted the

undertaking.

Firm has claimed manufacturer specifications.

No USP or BP monograph is available for applied formulation.



M/s. Wnsfeild Pharmaceuticals, Hattar

Brand Name +Dosage Form + Strength Noxiwin 8mg Injection

Composition Each injection of 2 ml contains:

Lornoxicam..8mg


Pharmacological Group NSAID

Type of Form Form-5

Finished product Specification Manufacturer specifications.

Pack size & Demanded Price As per policy of MOH



Approved by AGES of Austria

Me-too status Viltaz 8mg Injection by M/s. Wilshire Laboratories (Pvt)

Ltd. (Reg. No. 077112)

GMP status Last inspection conducted on 23-11-2016 stating GMP

compliance status.

Remarks of the Evaluator. Firm has claimed manufacturer specifications.

No USP or BP monograph is available for applied formulation.


Minutes for 273rd



M/s. Caliph Pharmaceuticals, Risalpur

Brand Name +Dosage Form + Strength Torment 50mg Capsule

Composition Each hard gelatin capsule contains:

Tramadol hydrochloride..50mg


Pharmacological Group Analgesic

Type of Form Form 5


Pack size & Demanded Price 3 x 10s; As recommended by the PRC (MOH)

Approval status of product in

Reference Regulatory Authorities.


Me-too status Trauma-Nil 50mg Capsules by M/s Global Pharmaceuticals

(Reg#026986)

GMP status Last inspection conducted on 07-03-2017 declaring

satisfactory level of GMP compliance.


Decision:Approved.


M/s. Caliph Pharmaceuticals, Risalpur

Brand Name +Dosage Form + Strength Linzole 100mg Dry Suspension

Composition After reconstitution each 5 ml contains:

Linezolid.100mg



Type of Form Form 5


Pack size & Demanded Price As recommended by the PRC (MOH)




Me-too status Linzol 100mg /5ml oral dry suspension by M/s Regal

Pharmaceuticals (Reg#081983)

GMP status Last inspection conducted on 07-03-2017 declaring






M/s. Nenza Pharmaceuticals, Peshawar

Brand Name +Dosage Form + Strength Nenkast 10mg Tablets

Composition Each film coated tablet contains:-

Montelukast (as sodium)..10mg


Pharmacological Group Leukotriene antagonist

Type of Form Form 5


Pack size & Demanded Price 2x7s ; As per SRO



Approved by USFDA

Me-too status Jukast -10 Tablet of M/s Jupiter Pharma (Reg.# 081919)

GMP status Last inspection report conducted on 31-03-2017 concluding



Decision:Approved

Minutes for 273rd



M/s Akhai Pharmaceuticals, Balochistan.

Brand Name +Dosage Form + Strength Akhvir 300mg Tablet


Tenofovir disoproxil fumarate..300 mg


Pharmacological Group Antiretroviral drugs

Type of Form Form 5

Finished product Specification International Pharmacopoea

Pack size & Demanded Price 10s, 2 x 10s, 3 X 10s; As per SRO/PRC



Approved by USFDA

Me-too status Hilten 300mg Tablet of M/s Hilton Karachi. (Reg.#

073735)

GMP status Last inspection report dated 25-01-2017 confirms good

compliance to GMP


Decision:Approved.



Brand Name +Dosage Form + Strength Solara 5mg Chewable Tablet

Composition Each Chewablet tablet contains:

Montelukast (as sodium).5mg


Pharmacological Group Antiasthamatics

Type of Form Form 5


Pack size & Demanded Price 2 x 7s; As per SRO/PRC



Approved by USFDA

Me-too status Montekast 5mg Tablets of M/s Legacy Pharmaceuticals

(Pvt) Ltd. (Reg.# 069785)


compliance to GMP


Decision:Approved.



Brand Name +Dosage Form + Strength Solara 10mg Tablet


Montelukast (as sodium)10mg



Type of Form Form 5





Approved by USFDA

Me-too status Montekast 10mg Tablets of M/s Global Pharmaceuticals.

(Reg.# 032154)


compliance to GMP


Decision:Approved.

Minutes for 273rd




Brand Name +Dosage Form + Strength Solara 4mg Chewable Tablet

Composition Each Chewablet tablet contains:

Montelukast (as sodium).4mg



Type of Form Form 5





Approved by USFDA

Me-too status Montekast 4mg Tablets of M/s Legacy Pharmaceuticals

(Pvt) Ltd. (Reg.# 069784)


compliance to GMP

Decision:Approved


M/s. MTI Medical, Lahore

Brand Name +Dosage Form + Strength Voriconazole 200mg Tablets


Voriconazole200mg


Pharmacological Group Antifungal

Type of Form Form 5


Pack size & Demanded Price 1 x 10s; As per SRO




Me-too status Vozo 200mg Tablet by M/s Hilton Pharma (Pvt.) Limited.

(Reg#053215)

GMP status Last inspection report conducted on 22-11-16 with

recommendations for Grant of Additional section.




M/s Indus Pharma, Karachi

Brand Name +Dosage Form + Strength Nitide 500mg Tablet


Nitazoxanide500 mg


Pharmacological Group Antiprotozoal agent

Type of Form Form 5

Finished product Specification Manufacturer specification

Pack size & Demanded Price Rs. 319 per pack of 20 tablets



Approved by USFDA

Me-too status Nizonide 500mg Tablet of M/s. AGP Pvt. Ltd. Karachi

(Reg.# 081101).

GMP status cGMP inspection conducted on 16-08-2017 concludes that

firm has been operating at acceptable level of GMP

compliance.



Minutes for 273rd



M/s Wimits Pharmaceuticals, Sundar Industrial Estate,

Raiwind Road, Lahore

Brand Name +Dosage Form + Strength Wascorel Tablet

Diary No. Date of R& I & fee Dy. No. 2703;Dated 30.12.2014; Rs. 20,000/-

Composition Each film ocate dtablet contains:

Clopidogrel as (bisulfate). 300 mg

Pharmacological Group Thienopyridine class inhibitor of P2Y12 ADP

Platelet receptors.

Type of Form Form-5


Pack size & Demanded Price 10s;As per SRO




Me-too status Ogrel 300 Tablet of M/s Bosch Karachi.

(Reg.#073525)

GMP status The firm is GMP compliant as per inspection

conducted on 10-10-2016.


Decision:Approved.




Brand Name +Dosage Form + Strength Viline- Met Tablet

Diary No. Date of R& I & fee Dy. No. 2711; Dated 30.12.2014; Rs. 20,000/-

Composition Each film coated tablet Contains:

Vildagliptin 50 mg

Metformin hydrochloride 1000 mg

Pharmacological Group Hypoglycemic agents:

Dipeptidyl peptidase-4 (DPP-4) inhibitor/Biguanide

Type of Form Form-5

Finished product Specification Manufacturers Specifications

Pack size & Demanded Price 30s; As per SRO




Me-too status GALVUS MET 50MG/1000mg Tablet of M/s Novartis

Pharma (Reg.#066107)




Decision:Approved with Innovators specifications and shelf life of 18 months with packaging

material of PA/Al/PVC/Al -polyamide-aluminum foil-polyvinylchloride/aluminum foil or

PCTFE/PVC/Alu or 2 years with PA/Alu/PVC/Alu.

http://www.rxlist.com/script/main/art.asp?articlekey=4941

Minutes for 273rd





Brand Name +Dosage Form + Strength Viline- Met Tablet

Diary No. Date of R& I & fee Dy. No. 2707/; Dated 30.12.2014;Rs. 20,000/-

Composition Each Tablet Contains:

Vildagliptin 50 mg

Metformin hydrochloride 850 mg

Pharmacological Group Hypoglycemic agents:

Dipeptidyl peptidase-4 (DPP-4) inhibitor/Biguanide

Type of Form Form-5


Pack size & Demanded Price 30s; As per SRO




Me-too status GALVUS MET 50MG/850mg Tablet of M/s Novartis

Pharma (Reg.#066106)




Decision:Approved with Innovators specifications and shelf life of 18 months with packaging

material of PA/Al/PVC/Al -polyamide-aluminum foil-polyvinylchloride/aluminum foil or

PCTFE/PVC/Alu or 2 years with PA/Alu/PVC/Alu.




Brand Name +Dosage Form + Strength Throtel Tablet

Diary No. Date of R& I & fee Dy. No. 2694; Dated 30.12.2014;20,000/-


Telithromycin . 400 mg

Pharmacological Group Antibacterial/Ketolide group

Type of Form Form-5


Pack size & Demanded Price 10s;As per SRO




Me-too status Engtel Tablet of M/s English Pharmaceuticals

Industries. (Reg.#041033)








Brand Name +Dosage Form + Strength Iromit Injection

Diary No. Date of R& I & fee Dy. No. 1306;Dated 24-06-2014; Rs. 20,000/-


Iron (III) Isomaltoside 100mg

Pharmacological Group Antianeamic, Iron Compounds for iron deficiency

Anemia

Type of Form Form-5


Pack size & Demanded Price 5 x 5ml; As per SRO

Minutes for 273rd





Me-too status Iron Wel Injection of M/s Welmark Pharmaceuticals






M/s Wimits Pharmaceuticals, Sundar Industri Estate,


Brand Name +Dosage Form + Strength Dexi Tablet



Dexibuprofen .. 300 mg

Pharmacological Group NSAID/ A Propionic acid Derivative

Type of Form Form-5


Pack size & Demanded Price 30s; as per SRO




Me-too status Rodexib 300mg Tablet of M/s Platinum Karachi

(Reg.#076397)








Brand Name +Dosage Form + Strength Wascorel Tablet

Diary No. Date of R& I & fee Dy. No. 2736; Dated 30-12-2014; Rs. 20,000/-


Clopidogrel (as bisulfate). 75 mg

Pharmacological Group Thienopyridine class inhibitor of P2Y12 ADP platelet

receptors.

Type of Form Form-5


Pack size & Demanded Price 30s;as per SRO




Me-too status M-Plate 75mg Tablets of M/s Mediate

Pharmaceuticals, Karachi. (Reg.#047275)




Decision:Approved.




Brand Name +Dosage Form + Strength Sitacor Plus Tablet

Diary No. Date of R& I & fee Dy. No. 2706;Dated 30-12-2014; Rs. 20,000/-


Sitagliptin .. 50 mg

Metformin hydrochloride.1000 mg

Pharmacological Group Anti-diabetic Agents

Dipeptidyl peptidase-4 (DPP-4) Inhibitor/Biguanide

http://www.rxlist.com/script/main/art.asp?articlekey=4941http://www.rxlist.com/script/main/art.asp?articlekey=33421

Minutes for 273rd


Type of Form Form-5


Pack size & Demanded Price 14s ; as per SRO




Me-too status TREVIAMET 50/1gm Tablet of M/s Getz

Pharmaceuticals (Reg.# 055444)




Decision:Approved.




Brand Name +Dosage Form + Strength Linzo Tablet



Linezolid ..600 mg

Pharmacological Group A synthetic antibacterial agent of the oxazolidinone class

Type of Form Form-5

Finished product Specification Manufacturers specifications Pack size & Demanded Price 10s; as per SRO



Zyvox by Pharmacia (USFDA Approved)

Me-too status Ecasil by Sami








Brand Name +Dosage Form + Strength Frumid Injection

Diary No. Date of R& I & fee Dy. No. 2712; Dated 30-12-2014; Rs. 20,000/-

Composition Each 2ml ampoule contains:

Furosemide .20 mg

Pharmacological Group Loop Diuretic

(Anthranilic acid derivative)

Type of Form Form-5


Pack size & Demanded Price 50 x 2mL;as per SRO




Me-too status Lasix injection by M/s Sanofi Aventis




Decision:Approved.







Dexibuprofen.. 200 mg


Minutes for 273rd


Type of Form Form-5






Me-too status Zibufen Tablets 200mg of M/s Global Pharmaceuticals

(Reg.#063410)








Brand Name +Dosage Form + Strength Wascorel-S Tablet

Diary No. Date of R& I & fee Dy. No. 2705/(R&I)Dated 30-12-2014; Rs. 20,000/-


Clopidogrel Bisulfate 75 mg

Aspirin . 75 mg

Pharmacological Group Thienopyridine class inhibitor of P2Y12 ADP platelet

receptors/ NSAIDs

Type of Form Form-5





Approved by TGA Australia

Me-too status Seaclop AP Tablets 75mg/75mg of M/s. Novamed

Pharmaceuticals (Reg.#059896)








Brand Name +Dosage Form + Strength Coxwit Tablet



Piroxicam (as Beta Cyclodextrin) 20 mg

Pharmacological Group Antipyretic, Analgesics

Type of Form Form-5

Finished product Specification Manufacturers specifications




ANSM-France approved

Me-too status Betadex Tablet of M/s. Ray Pharma (Pvt.) Ltd,

Karachi (Reg.#058257)






Minutes for 273rd





Brand Name +Dosage Form + Strength Myatra Injection

Diary No. Date of R& I & fee Dy. No. 2718/(R&I)Dated 30.12.2014; Rs. 20,000/-


Atracurium besylate .. 10 mg

Pharmacological Group Nondepolarizing Skeletal Muscle Relaxant

Type of Form Form-5


Pack size & Demanded Price 5 Amp x 2.5 mL; as per SRO




Me-too status Acuria Injection 25mg/2.5ml of M/s Getz pahrama

(Reg.#081076)




Decision:Approved




Brand Name +Dosage Form + Strength Sulo Capsules


Composition Each capsule Contains:

Tamsulosin hydrochloride...0.4mg

Source of pellets;

M/s Lee Pharma, India

Pharmacological Group Antagonist of alpha1A

Type of Form Form-5






Me-too status Uripro 0.4mg Capsule M/s Getz Pharma

(Reg.#081040)



Remarks of the Evaluator. Differential fee for import of pellets shall be submitted.

Decision:Deferred for submission of differential fee of Rs. 80,000/- for import of pellets.




Brand Name +Dosage Form + Strength Xantix Tablet



Tizanidine (as hydrochloride).. 2 mg

Pharmacological Group Skeletal Muscle Relaxant

(Central Alpha-2-Adrenergic Receptor Agonist)

Type of Form Form-5






Me-too status Fernor Tablet of M/s Lexicon Pharmaceutical, Karachi

(Reg.#042041)

Minutes for 273rd





Decision:Approved.




Brand Name +Dosage Form + Strength L-Nox Tablet

Diary No. Date of R& I & fee Dy. No. 2714/R&I Dated 30.12.2014 Rs. 20,000/-


Lornoxicam .. 8 mg

Pharmacological Group Nonsteroidal anti-inflammatory drug (NSAID) / oxicam

group.

Type of Form Form-5


Pack size & Demanded Price 10s AS PER SRO



Approved by EMA

Me-too status Spedicam by PharmEvo

GMP status The firm is GMP compliant as per inspection conducted

on 10-10-2016.






Brand Name +Dosage Form + Strength Dopamit Injection 5ml

Diary No. Date of R& I & fee Dy. No. 2746/(R&I)Dated 30-12-2014 Rs. 20,000/-


Dopamine hydrochloride .. 40 mg

Pharmacological Group Adrenergic Agonist (1 Agonist)

Dopamine hydrochloride is a naturally occurring

Catecholamine.

Type of Form Form-5


Pack size & Demanded Price 1 amp x 5 mL AS PER SRO




Me-too status INTROPIN INJECTION M/s Boots Co Karachi

(Reg.#010245)


on 10-10-2016.


Decision:Approved.





Diary No. Date of R& I & fee Dy. No. 2719/(R&I)Dated 30-12-2014 Rs. 20,000/-


Dexibuprofen .400 mg


Type of Form Form-5



Minutes for 273rd


Pack size & Demanded Price 30s; AS PER SRO




Me-too status Bekonil 400mg Tablet M/s Martin Dow Ltd. Karachi

(Reg.#081040)


on 10-10-2016.






Brand Name +Dosage Form + Strength L-Nox tablet

Diary No. Date of R& I & fee Dy. No. 2700/(R&I)Dated 30.12.2014 Rs. 20,000/-


Lornoxicam..4 mg

Pharmacological Group Nonsteroidal anti-inflammatory drug (NSAID)/oxicam

group.

Type of Form Form-5





Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG,

(Swiss Medic approved)

Me-too status Acabel 4mg Tablet by M/s Continental Pharma

(Reg No:061603)








Brand Name +Dosage Form + Strength Trozol Tablet

Diary No. Date of R& I & fee Rs. 20,000/-Dy. No. 2747/(R&I)Dated 30.12.2014


Letrozole 2.5 mg

Pharmacological Group Nonsteroidal aromatase inhibitor (inhibitor of estrogen

synthesis)

Type of Form Form-5






Me-too status Letzole Tablet 2.5MG M/s Pharmevo (Pvt.)

Ltd.,(Reg.#078104)


on 10-10-2016.


Decision:Approved in the light of decision made in 271st meeting of registreation Board

wherein Board decided to grant registration of these products in general manufacturing

areas with condition that manufacturer shall provide safety and protective measures for

workers and personnel which remain in direct contact or are involved in close handling of

these drugs

Minutes for 273rd





Brand Name +Dosage Form + Strength Linzo 400 mg Tablet



Linezolid .. 400 mg

Pharmacological Group A synthetic antibacterial agent of the oxazolidinone class

Type of Form Form-5

Finished product Specification USP Specifications Pack size & Demanded Price 10s AS PER SRO


Regulatory Authorities. Zyvox by Pfizer (USFDA approved)

Me-too status Nezocin by Brooks Pharmaceuticals, Karachi (Reg. No.

055004)








Brand Name +Dosage Form + Strength Levidol Syrup

Diary No. Date of R& I & fee Rs. 20,000/-Dy. No. 2738/(R&I)Dated 30-12-2014


Levocetirizine dihydrochloride . 2.5 mg

Pharmacological Group Antihistamine

Type of Form Form-5


Pack size & Demanded Price 60ml AS PER SRO




Me-too status Neo-Sedil by M/s Sami Pharmaceuticals (Reg#076065)








Brand Name +Dosage Form + Strength Opidol Tablet

Diary No. Date of R& I & fee Rs. 20,000/-Dy. No. 2717/(R&I)Dated 30-12-2014


Paracetamol........ 325

Tramadol hydrochloride.. ......37.5 mg

Pharmacological Group Analgesic/ Opioid Analgesic

Type of Form Form-5




Regulatory Authorities. Ultracet by Janssen (USFDA)

Me-too status Distalgesic Tablets by Atco laboratories, Karachi (R.

No. 073865)


on 10-10-2016.


Decision:Approved.

Minutes for 273rd





Brand Name +Dosage Form + Strength Sitacor Plus Tablet

Diary No. Date of R& I & fee Rs. 20,000/-Dy. No. 2737/(R&I Dated 30-12-2014


Sitagliptin .. 50 mg

Metformin hydrochloride. 500 mg

Pharmacological Group Anti-Diabetic Agents

Type of Form Form-5





TGA Australia approved.

Me-too status Janumet 50/500mg Tablet by M/s OBS, Karachi.


on 10-10-2016.






Brand Name +Dosage Form + Strength Wimgesic Injection

Diary No. Date of R& I & fee Dy. No. 2709/(R&I) Dated 30.12.2014;20,000/-

Composition Eaqch ml contains:

Nalbuphine hydrochloride.. 20 mg

Pharmacological Group Synthetic opioid agonist-antagonist analgesic

Type of Form Form-5





Nubain Injection 20mg/ml by M/s Sandoz Canada

Incorporated, Health Canada approved.

Me-too status Kinz 20mg/ml Injection by M/s Sami (Reg#018687)


on 10-10-2016.






Brand Name +Dosage Form + Strength Pivacan Injection 0.5%

Diary No. Date of R& I & fee Dy. No. 2733/(R&I) Rs.20,000/-Dated 30.12.2014


Bupivacaine hydrochloride. 5 mg

Pharmacological Group Local anaesthetic

Type of Form Form 5


Pack size & Demanded Price 10ml x 5s ; As per SRO




Me-too status Sensocain Injections Brookes Pharmaceuticals, Karachi

(Reg.#047396)


on 10-10-2016.


Decision:Approved.

Minutes for 273rd





Brand Name +Dosage Form + Strength Ebalin 75 mg Caps


Composition Each Capsule Contains

Pregabalin..75mg

Pharmacological Group Anti-Psychotic

Type of Form Form-5





USFDA approved

Me-too status Hilin capsules 75mg by Highnoon








Brand Name +Dosage Form + Strength Neuroline Injection

Diary No. Date of R& I & fee Rs. 20,000/-Dated 09.04.2014(Duplicate Dossier)


Citicoline (as sodium)..250mg

Pharmacological Group Nootropics & Neurotonic

Type of Form Form 5


Pack size & Demanded Price 5 Amp x 2 ml , Price as per SRO



Approved by ANSM of France

Me-too status CT-Nol 250mg Injection M/s Uni-Tiech

Pharmaceutials, Karachi (Reg.#047049)


on 10-10-2016.






Brand Name +Dosage Form + Strength Citrido Syrup

Diary No. Date of R& I & fee Rs. 20,000/- (23-12-2013) photocopy

Dated 09.04.2014(Duplicate Dossier)


Cetrizine dihydrochloride..5mg

Pharmacological Group Anti-Histamine

Type of Form Form 5


Pack size & Demanded Price 60ml, Price as per SO




Me-too status Rakzine Syrup M/s Rakaposhi Pharmaceutical Ltd.,

Peshawar (Reg.#033969).


on 10-10-2016.


Decision:Approved.

Minutes for 273rd





Brand Name +Dosage Form + Strength Trigex 100 mg tablet


Composition Each film coated tablet :

Sertraline hydrochloride 100 mg

Pharmacological Group Selective serotonin reuptake inhibitor

Type of Form Form-5


Pack size & Demanded Price 20sAS PER SRO




Me-too status Sayloft Tablet 100mg M/s Saydon Pharmaceuticals

Industries Ltd. (Reg.#080231)

GMP statu

Minutes for 273rd Meeting Registration Board held...

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Transcript of Minutes for 273rd Meeting Registration Board held...