Minutes for 254th Meeting Registration Board held on 11-12th November, 2015.

Item No. Detail of Item Page No(s) Item No.I Confirmation of minutes of 253rd meeting Registration Board 04 Item No.II Cases referred by Pharmaceutical Evaluation & Registration Division 04-391 Additional Cases Item No.III Cases referred by QA< Division 392-423 Item No.IV Cases referred by Pharmaceutical Evaluation & Registration Division 424-482 Item No.V Cases referred by Biological Drugs Division 483-567 Item No.VI Cases referred by Medical Device Division 568-572 Item No.VII Data Authenticity for New Chemical Entities / New Drugs 573-574

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254th meeting of Registration Board was held on 11-12th November, 2015 in the Committee Room, Health Services Academy, Islamabad. The meeting was chaired by Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division. The meeting started with recitation of the Holy Verses. The meeting was attended by the following:-

1. Prof. Dr.Rafi-uz-Zaman Saeed ul Haq Member Dean Institute of Pharmacy, University of Lahore, Islamabad. 2. Lt General (R) Karamat Ahmed Karamat. Member

3. Brig (R). Dr. Muzammil Hasan Najmi, Member Associate Dean, Basic Sciences Division, Foundation University Medical College, Rawalpindi 4. Sheikh Sarfraz Ahmad Member Deputy Draftsman, M/o Law and Justice 5. Mr.A.Q.Javed Iqbal Member 6. Dr.Muhammad Khalid Khan Member Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Peshawar 7. Dr.Amanullah Khan Member Director Drugs Testing Laboratory Government of Baluchistan, Quetta 8. Mr.Ghulam Mujtaba, Assistant Director Member Representative of IPO 9. Dr.Muhammad Arshad Member President, Pakistan Veterinary Medical Council 10. Shaikh Ansar Ahmad Member Director Biological Drugs, DRAP Representative of Biological Drugs Division 11. Dr.Noor Muhammad Shah Member Director MD&MC, DRAP Representative of Medical Device Division 12. Dr.Abdur Rasheed Member Chairman, Quality Control Representative of QA< Division 13. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary/Member

Dr.Muhammad Khalid Khan and and Mr.Ghulam Mujtaba attended the meeting on 11.11.2015.

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Dr.Masud-ur-Rehman (DDG Biological), Zaheer ud Din M Babar (DDC R.I / R IV), Muhammad Akhter Abbas (DDC / Incharge, PEC), Muhammad Amin (DDC, PEC), Adnan Faisal Saim (DDC QC), Babar Khan (ADC R.II / RIII), Salateen Phillips (ADC PEC) and Rana Ahsan ul Haq (ADC PEC) assisted relevant Directors and Secretary of the Board with agenda. Shafiq Ahmad Abbasi, Ahsan Naseer Awan, Nadeem Alamgeer and Shahzad Choudhary attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively. In addition to routine agenda, following was also discussed and decided:  254th meeting of Registration Board was held on 10-11th November, 2015. Draft minutes related to Agenda Item No. VII (Data Authenticity for New Chemical Entities / New Drugs) were circulated to all members who attended the meeting on 19.11.2015 through e-mail with the request to forward their comments (if any) within 02 days. None of the member forwarded their comments, thus action on that part has been taken. However, consolidated draft minutes (including Agenda Item No. VII) will be circulated.

 Registration Board was apprised that in 241st and 246th meetings it was decided that registration of new drugs / formulations for export purpose will be granted if applicant provide import order of any country. Registration Board deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting.

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Item No. I: Confirmation of minutes of 253rd meeting Registration Board.

253rd meeting of Registration Board was held on 05-06th October, 2015. Draft minutes were circulated to all members (who attended the meeting) through e-mail with the request to forward their comments (if any) within 05 days. Following are discussion points / observations: i) Biological Division forwarded draft minutes of 253rd meeting on 04.11.2015 and mentioned decision of Case No. 06 (a) as ‘approved as per Import Policy for Finished drugs’, where as instant case was recorded as ‘deferred for technical opinion of Dr.Muhammad Arshad (Member, Registration Board- veterinary expert) as he was not present in the meeting’ in draft minutes circulated to members.

ii) Director DTL, Quetta pointed out a typographic error in Item No.III (A) Case No.1, 28 as Dexlansoprazole 30 mg and 60 mg capsules instead of Sofosbuvir 400mg tablet.

iii) Director DTL, Peshawar pointed out a typographic error in Item No.III (A) Case No.1, 23 as Ledipasvir 90 mg + Sofosbuvir 400mg tablet instead of Sofosbuvir 400mg tablet.

Decision: Registration Board advised Biological Division to place case at point No.i in instant meeting for deliberation and decision. The Board approved draft minutes of 253rd meeting with above corrections mentioned at point No.ii and iii.

Item No.II: Cases referred by Pharmaceutical Evaluation & Registration Division.

A. Cases deferred in 253rd meeting Registration Board.

Miscelleneous Cases.

Case No.01: Contract Manufacturing Policy.

Rule 20A of Drugs (L R & A) Rules, 1976 pertains to contract manufacturing of drugs. These rules have been amended vide SRO 152(I)/2014 dated 04.03.2014. Sub-rule 2(b) is as follows:

2(b) Contract manufacturing shall be allowed only on basis of similar category of drugs including human to human, veterinary to veterinary, cotton to cotton, medical device to medical device or as the case may be, etc. M/s Chisti Pharma, Okara is a licensed pharmaceutical unit for cotton. The firm has submitted in 250th meeting of Registration Board that contract permission of our products Scifix (Cefixime) capsule(057380) and dry powder for suspension 100 mg (057382) and 200 mg (057381) has been denied. In this regard we want to present our submission as follows:

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 That our products were approved by registration board in 215th meeting and subsequently renewed in 238th meeting of registration board. Our products are manufactured by a GMP compliant facility McOlson Research Laboratories, Sheikhupura.

 It is a settled principle of law that a subordinate authority cannot make rules or issue notification under a statute so as to give them retrospective effect unless the statute itself grants such powers. (PLD 1967 Kar. 184 (DB), PLD 1972 SC 686, PLD 1974 SC 291 at page 309).

 Drug Act, 1976 empowers the federal government to make rules under section 43 of drugs Act, 1976 but it nowhere empowers to make rules with retrospective effect. Denial of renewal of our product based upon new contract policy is retrospective in its effect. Our products were granted by registration board in 215th meeting in 2009 and subsequently renewed in 238th meeting in 2014. It is unjust to deny renewal on the grounds that it doesn’t fall under new contract policy. When our products were granted approval, it was in accordance with the contract policy of registration board.

 According to Drugs Act, 1976 there is no categorization of DML for bandages manufacture. We were granted “Formulation” license by central licensing board and under this license other drugs like tablets, capsules, injectables can be manufactured. Therefore our DML has same legal value as it has for other dosage form manufacturers.

 Drugs Act, 1976 has also provided a procedure for cancellation of registration of a drug. No drug can be deregistered/cancelled unless opportunity of personal hearing is provided to the applicant. In our case this principle of law has also been denied.

Based upon above grounds, it is requested to review decision of the board and grant us extension of contract permission for our products. Sir, we have promoted our product through ethical means and years of efforts are involved in this process. Decision of Registration Board shall results in huge losses for our company and shall also deprive the patients from access to a quality drug.

Decision: Registration Board deliberated that Rule 20A was amended vide SRO 152(I)/2014 dated 04.03.2014 without saving clause. Whenever intention of law is to save the incumbent, a proviso is added to the law that amendment shall not apply to the incumbent beneficiaries. Since no saving provision was added in SRO 152(I)/2014 dated 04.03.2014, therefore provisions of aforementioned SRO very much applies to all existing and new contract permissions / registrations irrespective of date of permissions granted.

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Registration-I

Case No.02. Registration application of M/s. Medipak ltd. Lahore for Nephrotect injectable.

Registration Board in its 238th meeting held on 05-06th August, 2013 deferred below mentioned drugs for expert opinion by the following experts:- (i) Lt. Col. Dr. Zahid Farooq Baig, Armed Forces Institute of Urology, Rawalpindi, (ii) Head of Urology Department, SIUT, Civil Hospital, Karachi. (iii) Dr. Sohail Sabir, Military Hospital, Rawalpindi.

S.No. Name of Drug (s). Demanded Name of Indentor/ Price. Manufacturer. 1. Nephrotect Injectable Rs.1670/ M/s. Medipak Ltd Each 1000ml contains: - 250ml Lahore / Isoleucine………………….…5.80g Rs.2580/ M/s. Fresenius Kabi Austria Leucine……………………….12.8g 500ml GmbH, 8055 Graz, Austria. Lysine acetate………………...16.9g (12.0 g Lysine) Methionine……………………....2g Phenylalanine……………….. 3.50g Threonine…………………….8.20g Tryptophan…………………..…..3g Valine……………………..….8.70g Arginine……………………...9.80g Alanine…………………….…6.20g Acetylcysteine……………..…0.54g (0.40g cystenine) Glycine…………………….…5.31g Praline………………………..3.00g Serine………………………...7.60g Tyrosine……………………...0.60g Glycyl tyrosine…3.16g (0.99g glycine and 2.40g tyrosine) (Amino Acids)

Lt. Col. Dr. Zahid Farooq Baig, Armed Forces Institute of Urology, Rawalpindi has recommended the product for registration for patients of acute and chronic renal failure including patients on hemodialysis. The other two experts did not respond despite four reminders. The case was deferred by the Registration Board in its 252nd meeting for confirmation of approval status in reference regulatory authority. Decision: - As the product is approved by regulatory authority of Austria, which is a reference regulatory authority, thus Registration Board approved the application for registration of Nephrotect Injectable subject to inspection of manufacturer abroad as per policy, verification of storage facilities and price fixation / calculation etc.

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Case No.03. Change in Company name from M/S. Bayer Schering Pharma AG to M/S.Bayer Pharma AG.

M/s. Medipharm (Private) Limited, Lahore have informed that due to Bayer Group-wide initiative to change the name of the pharmaceutical company, they have requested to approved the change of the manufacturer name of their following registered imported drug.

Reg. No. Name of Drug. Current Name of Proposed Name of Manufacturing Site. Manufacturing Site / Source of Import 012367 Progyluton M/s. Bayer Schering Manufactured by: Tablets. Pharma AG, Germany. M/s. Bayer Weimar GmbH und Co. KG, Weimar, Germany. Source of Import: M/s. Bayer Pharma AG, 13342 Berlin, Germany.

M/s. Medipharm (Private) Limited, Lahore have deposited fee Rs.100000/- and supporting documents including ,Notarized Declaration from their Principal regarding the Name Change from Bayer Schering Pharma AG to Bayer Pharma AG, Original legalized CoPP Progyluton Tablets etc.

In the registration letter the manufacturer/ source of import was mentioned as M/s. Bayer Schering Pharma AG, Germany, while the firm claimed that the manufacturer even at that time was the same i-e M/s. Bayer Weimar GmbH und Co. KG, Weimar, Germany.

M/s. Medipharm (Private) Limited, Lahore was advised to clarify the following:-

i) As per CoPP the product is neither has valid license to be placed on market nor freely available in the country of origin as its “Re- registration was not granted, being manufactured by the exporting country which need clarification. ii) Brand name is different on CoPP as registered in Pakistan.

In response, M/s. Medipharm (Private) Limited, Lahore has submitted the following clarification:-  Product is already approved by competent authorities and available in

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Switzerland (Approval submitted with letter No. BHC-DRAP-14-075).  They have already submitted Notarized Declaration which state that product has never withdrawn not due to safety of efficacy reason in Germany.  They have provided CPP from Germany where this product is manufactured and GMP inspections are conducted.  The current request from authorities is only for Name Change the manufacturing site is same as registered with the authorities.

The Drug Registration Board in its 245th meeting held on 29-30th September, 2014 deferred the case due to non-availability in the country of origin i.e. Germany.

Now the firm has again requested to consider their case for change of manufacturer site/ source of import as the DRB in its 249th meeting recommended that products approved by USFDA, Health Canada, EMA, TGA Australia and PMDA Japan along with the regulatory authorities of United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in at least three European Union countries will also be taken as reference for consideration of Registration Board for approval.

The firm claimed that the product is available in Switzerland and provided CoPP from Swiss Medic, Switzerland. The case was deferred by the Registration Board in its 252nd meeting for further deliberations regarding products which are available in reference countries but do not have free sale status in country of origin.

Decision:- Registration Board deferred the case for further deliberations regarding products which are available in reference countries but do not have free sale status in country of origin.

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Case No.04: Cancellation of registration Of drug formulation(S) containing Chloramphenicol for Veterinary Use.

In pursuance of 239th Drug Registration Board’s meeting’s (held on 12th September, 2013) recommendations for banning the Chloramphenicol containing veterinary drugs formulations, Show Cause Notices were issued to the following firms for cancellation of drugs containing chloramphenicol in oral dosage form:-

S. No. Name of Firm. 1. M/s. Symans Pharmaceuticals (Pvt.) Ltd, Lahore. 2. M/s. Star Laboratories (Pvt.) Ltd, Lahore. 3. M/s. Farm Aid Group Pakistan, Hattar, Haripur. 4. M/s. Epla Laboratories (Pvt.) Ltd, Karachi. 5. M/s. Kaligon Agro Industries (Pvt) Ltd, Hub, Baluchistan. 6. M/s. Venus Pharma, Lahore. 7. M/s. S.J. & G. Fazul Ellahie (Pvt) Ltd, Karachi. 8. M/s. Nawan Laboratories (Pvt) Ltd, Karachi. 9. M/s. Leads Pharma (Pvt) Ltd, Islamabad. 10. M/s. Elko Organization (Pvt) Ltd, Karachi. 11. M/s. Rex Pharmaceutical Pakistan, Karachi. 12. M/s. Vetcon Pharmaceuticals (Pte) Ltd, Bhimbaer, AJK. 13. M/s. Manhattan Pharma, Karachi. 14. M/s. Alina Combine Pharmaceuticals (Pvt) Ltd, Karachi. 15. M/s. Mehran International, Karachi. 16. M/s. Atzan Pharmaceuticals (Pvt) Ltd, Sargodha. 17. M/s. Class Pharam Pakistan, Lahore. 18. M/s. Vety-Care (Pvt) Ltd, Rawalpindi. 19. M/s. Vigilant Veterinary Services (Pvt) Ltd, Lahore. 20. M/s. Global Veterinary & Technical Services (Pvt) Ltd, Multan. 21. M/s. Aims Traders, Lahore. From responses received from a few firms following points were highlighted:-

(i) Beside oral dosage form the chloramphenicol is also available in injectable and spray form. (ii) The use of chloramphenicol should be restricted in food consuming animals.

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The next step after Show Cause is the personal hearing by the DRB. However, the matter of inclusion of injectable and spray dosage form in these Show Cause Notices require clarification. The case was deferred by the Registration Board in its 252nd meeting due to paucity of time. Decision:- Registration Board decided to also issue Show Cause Notices to the firms having registration of Chloramphenicol in injectable and spray dosage forms.

Case No.05. Surgical sutures- M/s. Zenith international, Karachi.

Registration Board in its 243rd meeting deferred following products for expert opinion.

S. Name of Name of drug (s) / Demanded Shelf Date of No. Indenter/ Composition Price/Pack Life application Manufacturer & Therapeutic Group receiving & fee. 1. M/s. Zenith “Trusilk” Black Silk Braided As per PRC 05 07-06-2012 International, (Non-absorbable Surgical years Rs.15000 + Karachi. / Suture U.S.P) (Without Rs.85000 = Manufactured by Needle) (All sizes). Rs.100000/- M/s. Sutures India (Pvt) Ltd. Bangalore, India. 2. M/s. Zenith “Trulene Mesh” Non- As per PRC 05 07-06-2012 International, absorbable Polypropylene years Rs.15000 + Karachi. / Surgical Mesh (All sizes) Rs.35000 = Manufactured by Rs.50000/- M/s. Sutures India (Pvt) Ltd. Bangalore, India. 3. M/s. Zenith “Trulene” As per PRC 05 13-06-2012 International, Monofilament Polypropylene years Rs.15000 + Karachi. / (Non-absorbable Surgical Rs.35000 = Manufactured by Suture U.S.P) (With or Rs.50000/- M/s. Sutures Without Needle) (All Size) India (Pvt) Ltd. Bangalore, India. 4. M/s. Zenith “Trusynth” As per PRC 05 13-06-2012 International, Polyglactin 910 (Absorbable years Rs.15000 + Karachi. / Surgical Suture U.S.P, Rs.35000 = Manufactured by Synthetic) (With or Without Rs.50000/- M/s. Sutures Needle) (All Size) India (Pvt) Ltd.

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Bangalore, India. 5. M/s. Zenith “Truglyde” As per PRC 05 13-06-2012 International, Polyglycolic Acid years Rs.15000 + Karachi. / (Absorbable Surgical Suture Rs.35000 = Manufactured by U.S.P Synthetic) (With or Rs.50000/- M/s. Sutures Without Needle) (All Size) India (Pvt) Ltd. Bangalore, India. 6. M/s. Zenith “Trugut” Chromic Catgut As per PRC 05 Rs.15000 + International, (Absorbable Surgical Suture years Rs.85000 = Karachi. / U.S.P) (With or Without Rs.100000/- Manufactured by Needle) (All sizes) M/s. Sutures (Surgical Suture). India (Pvt) Ltd. Bangalore, India.

2. The suture mentioned from Serial No.1-5 above were sent to the expert in compliance to the Board decision. The comments of the experts are summarized as under. Prof. Imran Skindar, Prof. Moeed. Iqbal Qureshi, Lt. Col. Dr. Farhan Ahmad Head Department of Head, Department of Majeed, Orthopedic Surgery, General Surgery, Professor of Surgery, Pakistan Institute of Sheikh Zayed Hospital, Combined Military Hospital, Medical Sciences, Lahore. Rawalpindi. Islamabad. I have used & tested the We used these sutures and Awaited. Three reminders following sutures for surgical found satisfactory in relation issued to the expert but reply use and found them to be to needle behavior, thread is still awaited. satisfactory. strength & knot ability. The long term efficacy of these sutures cannot be determined.

3. The “Trugut” Chromic Catgut mentioned at Serial No.6 above was not sent for expert opinion as the firm did not provide the EC certificate. Now M/s. Zenith International, Karachi vide a letter claimed that EC Authority do not issue CE certificate to any manufacturer for Chromic Catgut since several years. They further claimed that their principal are exporting this product to USA. Decision:- Since the products at Serial No. 1 to 5 are recommended by the two experts, so the Registration Board approved the registration of these products subject to inspection of manufacturer abroad as per policy, verification of storage facilities and price fixation / calculation etc. For the product Trugut” Chromic Catgut (Serial No.6) the Board advised

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that the firm should provide an appropriate certificate from the concerned regulatory authority as evidence of it’s free sale.

Case No.06. Registration of Drugs under Drugs Act, 1976.

The Drug Registration Board 249th meeting took following decision regarding products containing Amantadine with antibiotics:

“Rejected as Amantadine” which is antiviral drug for flu and may have drug interaction and resistance problem so should not be used in these combinations. The Board also decided to issue show cause notice to already registered products for cancellation (If applicable)”. Registration Board in its 242nd & 245th meetings approved under mentioned locally manufactured veterinary drugs containing such combinations of Amantadine. However, Registration letters were not issued as yet due to completion of other formalities i.e. CRF.

S.No Name of Name of drug(s) & Maximum Approved Applicants Composition. Retail Price/ Shelf Life. Packing 1. M/s. Cherished E-Colidine CP Water Soluble De-controlled 02 years Pharmaceuticals Powder 100gm (Private) Limited, Each 1000g powder contains:- 500gm Lahore. Enrofloxacin HCl……..100gm 1000gm Colistin Sulphate……….40gm Amantadine HCl……...40gm

2. M/s. Moreno Colisheph Liquid De-controlled 02 years Iglisias Research Each 100ml contains:- 100ml Laboratories (Pvt) Colistin Sulphate…...50gm 250ml Ltd., Lahore. Amantadine………....gm 500ml 1000ml 3. -do- Enrosheph Liquid De-controlled 02 years Each 100ml contains:- 100ml Enrofloxacin……...... 10gm 250ml Colistin sulphate………5gm 500ml Amantadine……...…….5gm 1000ml

Decision:- In view of the decision taken in 249th meeting, Registration Board decided to reject the above mentioned applications.

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Case No. 07. Drugs deferred by Registration Board-Ventiplus Suspension.

Registration Board deferred the application for registration of Ventiplus Suspension in its 250th meeting held on 09-10th July, 2015as per following detail.

S. # Name of Name of Drug (s) Demanded Shelf Decision Manufacturer / Composition & Price & Life Importer. Therapeutic Group. Pack Size.

1. M/s. Ghani Ventiplus Suspension As per 02 years Deferred as Brothers, Karachi. / 100mcg Inhaler HFA brand leader the firm has M/s. Laboratorios Each inhaled dose not provided Haymann S.A. contains:- legalized Gianelli 1489, Salbutamol (as English Montevideo sulfate)……….0.100mg translation of Uruguay. (Beta-2, Adrenergic the market Agonist). authorization.

Accordingly, firm was advised to provide the same information and the firm has submitted the legalized English translation of the market authorization. Decision:- Registration Board approved the application for registration of Ventiplus Suspension 100mcg Inhaler HFA subject to inspection of manufacturer abroad as per policy, verification of storage facilities and price fixation / calculation etc.

Case No. 08. Registration of Drugs under Drugs Act, 1976 - Xarelto 2.5mg Tablets.

Registration Board in its 243rd meeting approved/registered following drug and registration letter is prepared as per following details:- S.# Name of Manufacturer/ Name of drug(s) & Approved MRP Importer. Composition with Demanded with reference of MRP. meeting/ Pack Size 1. M/s. Bayer Pakistan (Private) Xarelto 2.5mg Tablets. Rs.3617.00/14’s. Limited, Karachi. / Each tablet contains:- Rs.6872.00/28’s. Marketing Authorization Rivaroxaban…….2.5mg. holder: - (12th DPC) M/s. Bayer Pharma AG, 13342 Rs.13230/Per packs of 14’s. Berlin, Germany. Rs.26460/Per packs of 28’s. Manufactured by: - M/s. Bayer Pharma AG, 51368 Leverkusen, Germany. Secondary Packaging: - M/s. Stegemann

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Lohnverpackung & Logistischer Service e.K., Up’n Nien Esch 14, 48268 Greven, Germany.

CoPP issued by EMA bearing No.09/13/67552 for Xarelto 2.5mg Tablets, has details of marketing authorization holder, manufacturing and secondary packing. Though Registration Board approved the product as per CoPP, but in minutes of 243rd meeting only name of manufacturer was mentioned. The registration letter has been issued as per detail mentioned in EMA’s CoPP containing the above mentioned information. Decision: - Registration Board endorsed the position stated above.

Case No. 09. Updated Patient Information Leaflet “Prozac 20mg Capsules (Reg. No.010772).

M/s. Eli Lilly Pakistan (Private) Limited, Karachi have informed that they did an assessment exercise of their Standard Information Leaflets globally for multiple promoted products and noted that their current standard leaflet of Prozec 20mg Capsules (Reg. No.010772) also includes information of Pozac Liquid based on its registration and marketing status in several countries. As they do not possess registration of Prozac Liquid in Pakistan so they intend to update Prozac 20mg Capsule leaflet by deleting all information related to Prozac Liquid formulation. M/s. Eli Lilly Pakistan (Private) Limited, Karachi have deposited fee Rs.5000/- and submitted following supporting documents:- i) Existing Leaflet. ii) Updated Leaflet.

From perusal of the literature /prescriber’s information the contents proposed to be deleted includes the information relating to effect of Prozac on children and adolescent. Since the firm did not specifically bare its use in the aforementioned group, so this information is proposed to be retained in the literature while the information which directly refers to use of liquid formulation may be considered for deletion. Decision: - Registration Board directed to advise the firm that the information relating to effect of Prozac on children and adolescent should be retained in the literature, while only the information which directly refers to use of liquid formulation be deleted.

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Case No. 10. Correction of typhographic error in minutes. The Drugs Registration Board in its 247th meeting held on 04th February, 2015 approved the under mentioned locally manufactured veterinary drugs. S.No Name of Applicant Name of drug(s) & Pack size Composition. mentioned in Minutes 1. Leads Pharma (Pvt) NC Strep Powder 100ml Ltd. Islamabad. Each gm contains:- 250ml Neomycin sulphate…60mg 500ml Chlortetracycline….200mg 1Litre Streptomycin sulphate…………….20mg

The product was approved as powder but packs sizes mentioned in liquid form due to typographic error. As per dossier the firm had applied for 100gm, 250gm, 500gm & 1Kg packs sizes which was inadvertently written as 100ml, 250ml, 500ml & 1 Litre in the agenda & minutes. The registration letter has been issued after approval of the correction by Chairman, Drug Registration Board. Decision:- Registration Board endorsed the decision of correction of above mentioned typographic error.

Case No. 11. Request of M/S. Glaxosmithkline Pakistan Limited, Karachi for change of manufacturing site/source of their registered imported drug “Isotrexin Gel (Reg. No.047552)”.

M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change of manufacturing site/source of their registered imported drug “Isotrexin Gel (Reg. No.047552)” from M/s. Stiefel Laboratories (Pte) Ltd., Singapore to M/s. Glaxo Operations UK Limited, Barnard Castle, UK. The firm has deposited fee Rs.100000/- and submitted following supporting documents:- i) Copy of initial registration letter. ii) Copy of transfer of registration from M/s. Stiefel Laboratories Pakistan (Pvt) Ltd., Lahore to M/s. GlaxoSmithKline Pakistan Limited, Karachi. iii) Original legalized CoPP from new source UK. iv) NOC for CRF Clearance. v) Application on Form 5(A). vi) Site Master File of New Manufacturing Site.

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Decision:- In view of M/s. GlaxoSmithKline Pakistan Limited, Karachi’s own request, Registration Board decided to reject the application.

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Registration-II

Case No. 12 Registration of Drugs for export purpose - Not me too (New Drugs) a. Grant of export registration:

Following firms have requested for registration of following drugs for export purpose only which are not me-too & are new drugs. Details are as under:-

S. Name of Name of product(s) Date of Import Order Approval status by No. Company application, reference regulatory Diary No. & authorities Form 1. M/s Pharmatec Reltus C&F Capsules 24.07.2015 Copy of import 1. Formulation is Pakistan (Pvt) Each capsule contains: 120 Order from present in India in Ltd., Karachi Paracetamol…..300mg Rs. 20,000/- Cambodia Tablet. Phenylephrine HCl…..5mg 2. Already Chlorpheniramine Maleate…4mg registered in Pakistan Caffeine Anhydrous….30mg for export of Pharmatec with name of Fludol (Reg. No.004098). 2. -do- Exo Cream 22.09.2015 Copy of import Available in UK Each gram contains 947 order from White soft paraffin…14.5% w/w Rs. 20,000/- United Light Liquid paraffin..12.6% w/w Kingdom Hypo allergenic Anyhdrous Lanoline………………..1% w/w 3. M/s Hilton Aloglu 12.5 mg Tablet 08.06.2015 Copy of import MHRA approved Pharma (Pvt) Each film coated tablet contains: 250 Order from Ltd, Karachi Alogliptin Benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin 12.5 mg 4. M/s Atco Sofos Tablet 400mg 28.07.2015 Copy of import USFDA approved Laboratories Each film coated tablet contains: 133 Order from Limited, Sofosbuvir …..400mg Rs.20,000/- Vietnam Karachi (Manufacturer Specification) 5. M/s Hilton Aloglu-P Tablet 12.5/15mg 25.08.2015 Copy of import USFDA approved Pharma (Pvt) Each film coated tablet contains: 277 Order from Ltd, Karachi Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin …..…….…….12.5mg Pioglitazone HCl equivalent to Pioglitazone ……….…….15mg

6. -do- Aloglu-P Tablet 25/15mg 25.08.2015 Copy of import USFDA approved Each film coated tablet contains: 278 Order from Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan

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Alogliptin ………………..25mg Pioglitazone HCl equivalent to Pioglitazone ……………..15mg

7. -do- Aloglu-Met tablet 12.5/500mg 25.08.2015 Copy of import USFDA approved Each film coated tablet contains: 271 Order from Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin.. …………12.5mg Metformin HCl…………500mg

8. -do- Aloglue-P tablet 25/30mg 25.08.2015 Copy of import USFDA approved Each film coated tablet contains: 272 Order from Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin ………….25mg Pioglitazone HCl………30mg

9. M/s Hilton Aloglu-P tablets 12.5/45mg 25.08.2015 Copy of import USFDA approved Pharma (Pvt) Each film coated tablet contains: 275 Order from Ltd, Karachi Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin ……………….12.5mg Pioglitazone HCl equivalent to Pioglitazone …………45mg 10. -do- Aloglu-P tablets 25/45mg 25.08.2015 Copy of import USFDA approved Each film coated tablet contains: 276 Order from Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin ………….25mg Pioglitazone HCl equivalent to Pioglitazone ………45mg 11. -do- Aloglu-P tablet 12.5/30mg 25.08.2015 Copy of import USFDA approved Each film coated tablet contains: 274 Order from Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin ………12.5mg Pioglitazone HCl equivalent to Pioglitazone ……30mg 12. -do- Aloglu-Met tablet 12.5/1000mg 25.08.2015 Copy of import USFDA approved Each film coated tablet contains: 273 Order from Alogliptin benzoate equivalent to Rs. 20,000/- Afghanistan Alogliptin ………12.5mg Metformin HCl ……1000mg 13. -do- Medilyza tablet 20.01.2015 Copy of import USFDA approved Each film coated tablet contains: 910 Order from Sri Saxagliptin (as Rs. 20,000/- Lanka hydrochloride)………..5mg 14. -do- Medjenta tablet 20.01.2015 USFDA approved Each film coated tablet contains: 911 Linagliptin………..5mg Rs. 20,000/-

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15. Amarant Flurant DM Syrup 25.06.2015 Not provided by Firm Pharmaceutical Each 5ml contains 421 , Karachi. Dextromethorphan HBr….10 mg Rs. 20,000/- Pseudoephedrine HCl…….30 mg Chlorpheniramine Maleate...2 mg 16. -do-. Amasof tablet 400mg 25.06.2015 USFDA approved Each film coated tablet contains: 423 Sofosbuvir………..400mg Rs. 20,000/- 17. -do- Flurant Capsule 25.06.2015 Not provided by Firm Each capsule contains: 422 Paracetamol BP…………300mg Rs. 20,000/- Pseudoephedrine HCl USP...30mg Caffeine Anhydrous BP….. 30mg Chlorpheniramine Maleate BP……………..….4mg 18. Sami Trimetabol Oral Solution 08.06.2015 Copy of import Approved by Pharmaceutical Each 100ml contains 243 Order from regulatory authority , Karachi Cyproheptadine Acefilinate Rs. 20,000/- Switzerland of Spain (Metopine®)……………35mg L-lysine HCl……………..5g DL-Carnitine HCl……….7.5g Thiamine HCl (Vitamin B1)………………………600mg Pyridoxine HCl. (vitamin B6)……………………600mg Cyanocobalamin (vitamin B12)………….20mg

19. Hilton Pharma, Clavir 60mg tablet 17.09.2015 Copy of import USFDA approved Each tablet contains 924 order from Daclatasvir…………60mg (eq. to Rs. 20,000/- Afghanistan 66mg declatasvir dihydrochloride)

20. -do- Clavir 30mg tablet 17.09.2015 -do- USFDA approved Each tablet contains 925 Daclatasvir……..30mg (eq. to Rs. 20,000/- 33mg daclatasvir dihydrochloride)

21. -do- Dapa 5mg tablet 17.09.2015 -do- USFDA approved Each extended release tablet 927 contains Rs. 20,000/- Dapagliflozin Propanediol Monohydrate equivalent to

Minutes for 254th Registration Board Meeting 19

Dapagliflozin…………5mg 22. -do- Dapa – Met 5/850 tablet 17.09.2015 -do- MHRA approved Each film coated tablet contains 926 Dapagliflozin propanediol Rs. 20,000/- monohydrate eq to Dapagliflozin……….5mg Metformin HCl……..850mg 23. -do- Dapa – Met 5/1000mg tablet 17.09.2015 -do- MHRA approved Each film coated tablet contains 928 Dapagliflozin propanediol Rs. 20,000/- monohydrate eq to Dapagliflozin……….5mg Metformin HCl……..1000mg 24. -do- Dapa 10mg tablet 17.09.2015 -do- USFDA approved Each film conated tablet contains 929 Dapagliflozin Propanediol Rs.20,000/- Monohydrate Equivalent to Dapagliflozin…………10mg 25. -do- Empa 10mg tablet 18.09.2015 -do- USFDA approved Each film coated tablet contains 931 Empagliflozin………….10mg Rs. 20,000/- 26. -do- Empa 25mg tablet 18.09.2015 -do- USFDA approved Each film coated tablet contains 930 Empagliflozin………….25mg Rs. 20,000/- 27. -do- Vasac 49/51mg tablet 22.09.2015 -do- USFDA approved Each film coated tablet contains 932 Sacubitril……..49mg Rs. 20,000/- Valsartan……..51mg 28. -do- Vasac 97/103mg tablet 22.09.2015 -do- USFDA approved Each film coated tablet contains 933 Sacubitril……….97mg Rs. 20,000/- Valsartan………103mg 29. -do- Vornew 20mg tablet 22.09.2015 Copy of import USFDA approved Each film coated tablet contains 935 order from Vortioxetine HBr eq. to Rs. 20,000/- Afghanistan Vortioxetine………20mg

30. -do- Vornew 15mg Tablets 22.09.2015 -do- USFDA approved Each film coated tablet contains: 934 Vortioxetine HBr eq. to Rs. 20,000/- Vortioxetine…………15mg 31. -do- Vornew 10mg tablet 22.09.2015 -do- USFDA approved Each film coated tablet contains: 936 Vortioxetine HBr eq. to Rs. 20,000/- Vortioxetine………10mg

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32. -do- Vornew 5mg tablet 22.09.2015 -do- USFDA approved Each film coated tablet contains: 937 Vortioxetine HBr eq. to Rs. 20,000/- Vortioxetine………5mg 33. -do- Vasac 24/26mg tablet 22.09.2015 -do- USFDA approved Each film coated tablet contains 938 Sacubitril……….24mg Rs. 20,000/- Valsartan……….26mg 34. -do- Rasidon 20mg tablets 22.09.2015 -do- USFDA approved Each film coated tablet contains 939 Lurasidone HCl …..20mg Rs. 20,000/- 35. -do- Rasidon 40mg 22.09.2015 -do- USFDA approved Each film coated tablet contains 941 Lurasidone HCl.……….40mg Rs. 20,000/- 36. -do- Rasodom 60mg tablets 22.09.2015 -do- USFDA approved Each film coated tablet contains 944 Lurasidone HCl ……..60mg Rs. 20,000/- 37. -do- Rasidom 80mg tablets 22.09.2015 -do- USFDA approved Each film coated tablet contains 945 Lurasidone HCl……..80mg Rs. 20,000/- 38. -do- Rasidom 120mg tablets 22.09.2015 -do- USFDA approved Each film coated tablet contains 946 Lurasidone HCl ……..120mg Rs. 20,000/- 39. -do- Hilto-D 7.5mg Injection 22.09.2015 -do- Not provided by Firm Each ml contains 940 Vitamin D3 Rs. 20,000/- (Cholecalciferol)……7.5mg (300,000IU) 40. -do- Hilto – D Drop 22.09.2015 -do- Not provided by Firm Each ml contains 942 Vitamin D3 Rs. 20,000/- (Cholecalciferol)…….400IU 41. -do- Hilto – D Sachet 22.09.2015 -do- Available in India Each sachet contains 943 Vitamin D3 Rs. 20,000/- (Chlecalciferol)……60,000IU

42. -do- Esli 200mg tablet 28.09.2015 Copy of import USFDA approved Each tablet contains: 956 order from Eslicarbazepine Acetate….200mg Rs. 20,000/- Afghanistan 43. -do- Esli 400mg tablet 28.09.2015 -do- USFDA approved Each tablet contains: 957 Eslicarbazepine Acetate….400mg Rs. 20,000/- 44. -do- Esli 800mg tablet 28.09.2015 -do- USFDA approved Each tablet contains: 955 Eslicarbazepine Acetate…800mg Rs. 20,000/-

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45. -do- Apix 2.5mg tablet 28.09.2015 -do- USFDA approved Each film coated tablet contains: 958 Apixaban…………2.5mg Rs. 20,000/- 46. -do- Apix 5mg tablet 28.09.2015 -do- USFDA approved Each film coated tablet contains: 959 Apixaban…………5mg Rs. 20,000/-

47. Hiranis Etoxib Tablet 120mg 28.09.2015 Copy of import USFDA approved Pharmaceutical Each film coated tablet contains 948 order from , Karachi Etoricoxib………..120mg Rs. 20,000/- Uzbekistan (Manufacturer Specification) 48. -do- Extoxib Tablet 90mg 28.09.2015 -do- USFDA approved Each film coated tablet contains 949 Etoricoxib………….90mg Rs. 20,000/- (Manufacturer Specification)

Decision: Registration Board was apprised that in 241st and 246th meeting it was decided that registration of new drugs / formulations for export purpose will be granted if applicant provide import order of any country. Registration Board deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. Accordingly, above case was decided as follows:  Approved grant of registrations for export purpose for above items except at S.No. 1, 15, 17, 18, 39, 40 and 41. Firm will deposit remaining fee for grant of registration and Chairman, Registratiuon Board will then permit isuuance of export registration letter. Manufacturer will comply following conditions before export of drug: a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product.  Deferred items at S.No. 1, 15, 17, 18, 39, 40 and 41 for deliberation in forthcoming meeting as decided above.

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b. Correction in composition

The Registration Board approved registration of following formulation in its 249th meeting for export purpose. At the time of issuance it was identified that approval was inadvertently granted in 60mg which is not available in any SRA’s country later on it was found that the firm has applied in the strength of 80mg.

12 M/s. The Searle Azetan Tablet 80mg As per Company Limited, Each tablet contains: requirement of F-319, S.I.T.E., Azilsartan…………80mg importing country Karachi

Decision: Registration Board approved the correction in the composition of the product.

c. Registration of drugs for export purpose through contract manufacturers

M/s Kaizen Pharmaceuitcal, D-37, Block 7, Clifton, Karachi have applied for cotract manufacturer of their following applied products for export purpose from M/s UDL Pharmaceutical, Karachi. M/s UDL, possesses the manufacturing facility of cephalosporin (Dry Suspension). S. Name of Contract Name of product(s) for Date of Remarks No. applicant manufacturer export application, Diary No. & Form 1. Kaizen UDL, Serve DS Dry 18.08.2015 - Pharmaceutical, Pharmaceutical, Suspension 200mg 232 D-37, Block – 7, Karachi Each 5ml contains Rs.20,000/- Clifton, Cefixime (as Karachi. trihydrate)……..200mg 2. -do- -do- Serve Dry Suspension 18.08.2015 - 100mg 231 Each 5ml contains: Rs.20,000/- Cefixime (as trihydrate)……100mg 3. -do- -do- Serve Capsule 400mg 18.08.2015 - Each capsule contains: 230 Cefixime (as Rs.20,000/- trihydrate)…….400mg 4. -do- -do- Serve Capsule 200mg 18.08.2015 Product not Each capsule contains: 229 available in

Minutes for 254th Registration Board Meeting 23

Cefixime (as Rs.20,000/- USA & UK. trihydrate)….200mg

5. -do- -do- Cefture Injection 18.08.2015 - 1000mg IV 228 Each vial contains: Rs.20,000/- Ceftriaxone (as sodium)…….1000mg 6. -do- -do- Ceftcure Injection 18.08.2015 - 500mg IV 227 Each vial contains: Rs.20,000/- Ceftriaxone (as sodium)……500mg 7. -do- -do- Ceftcure Injection 18.08.2015 - 250mg IV 226 Each vial contains: Rs.20,000/- Ceftriaxone (as sodium)…….250mg

Decision: Registration Board approved registration of above products (on contract manufacturing basis) for export purpose only except for the product at S. No.4 which was deferred for approval status by reference regulatory authorities and then discussion by Registration Board.

Case No.13. Grant of registration on contract manufacturing basis.

a. M/s Atco Laboratories Limited, Karachi.

M/s Atco Laboratories Limited, Karachi has requested for grant of registration of following products through contract manufacturing as per following details:

S.No Applicant Contract Name of Drug(s) & Date of . manufacturer Composition application, Diary No. & Fee 1) ATCO Opal Laboratories, Fiximax tablet 200mg 06.03.2015 Laboratories, Karachi Each film coated tablet contains DyNo.109 Karachi Cefixime (as trihydrate) Rs.8,000/- USP……………………200mg 15.09.2010 Rs.42,000/- 12.03.2013 2) -do- -do- Fiximax Capsule 400mg 06.03.2015 Each capsule contains DyNo.108 Cefixime (as trihydrate) Rs.8,000/- USP……………………400mg 30.08.2010

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Rs.42,000/- 12.03.2013 3) -do- -do- Fiximax DS Powder for oral 06.03.2015 Suspension USP DyNo.110 Each constituted 5ml contains Rs.8,000/- Cefixime (as trihydrate) 30.08.2010 USP…………………….200mg Rs.42,000/- 12.03.2013 4) -do- -do- Fiximax Powder for oral 06.03.2015 Suspension USP DyNo.111 Each constituted 5ml contains Rs.8,000/- Cefixime (as trihydrate) 30.08.2010 USP…………………….100mg Rs.42,000/- 12.03.2013

Decision: Registration Board approved registration of above products on contract manufacturing basis from M/s Opal Laboratories, Karachi.

b. M/s Amarant Pharmaceutical (Pvt) Ltd., Karachi.

M/s Amarant Pharmaceutical (Pvt) Ltd., Karachi have applied for registration of following drugs through contract manufacturing from M/s Medicaids, Karachi. The M/s Medicaids have approved manufacturing facility from CLB.

S.# Name of product(s) with composition. Date of application, diary No. & Fee 1. Zidim dry powder Injection 250mg Rs.8,000/- dated 30.09.2010 Each vial contains: Rs. 12,000/- dated 21.05.2013 Ceftazidime (as pentahydrate with sodium Rs. 30,000/- dated 15.04.2014 carbonate)……………………250mg 2. Zidim dry powder Injection 500mg Rs.8,000/- dated 30.09.2010 Each vial contains: Rs. 12,000/- dated 21.05.2013 Ceftazidime (as pentahydrate with sodium Rs. 30,000/- dated 15.04.2014 carbonate)………………….500mg 3. Zidim dry powder Injection 1gm Rs.8,000/- dated 30.09.2010 Each vial contains: Rs. 12,000/- dated 21.05.2013 Ceftazidime (as pentahydrate with sodium Rs. 30,000/- dated 15.04.2014 carbonate)………………....1gm

4. Ampax dry powder Injection 250mg Rs.8,000/- dated 30.09.2010 Each vial contains Rs. 12,000/- dated 21.05.2013 Cefotaxime (as sodium) ………....250mg Rs. 30,000/- dated 15.04.2014

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5. Ampax dry powder Injection 500mg Rs.8,000/- dated 30.09.2010 Each vial contains Rs. 12,000/- dated 21.05.2013 Cefotaxime (as sodium) ………….500mg Rs. 30,000/- dated 15.04.2014 6. Ampax dry powder Injection 1gm Rs.8,000/- dated 30.09.2010 Each vial contains Rs. 12,000/- dated 21.05.2013 Cefotaxime (as sodium) ………..…..1gm Rs. 30,000/- dated 15.04.2014 7. Amtraxa I/M 250mg Rs.8,000/- dated 30.09.2010 Each vial contains: Rs. 12,000/-dated 21.05.2013 Ceftriaxone (as sodium) …………250mg Rs. 30,000/- dated 15.04.2014 8. Adonis dry powder Injection 500mg Rs.8,000/- dated 30.09.2010 Each vial contains: Rs. 12,000/- dated 21.05.2013 Cefepime (with L-arginine)……….500mg Rs. 30,000/- dated 15.04.2014 9. Adonis dry powder Injection 1gm Rs.8,000/- dated 30.09.2010 Each vial contains: Rs. 12,000/- dated 21.05.2013 Cefepime (with L-arginine)…..….….1gm Rs. 30,000/- dated 15.04.2014

Decision: Registration Board approved registration of above products on contract manufacturing basis from M/s Medicaids, Karachi.

Case No.14 Registration of products from one manufacturer to another:

a. M/s Ray Pharma (Pvt) Ltd., to M/s. Kaizen Pharmaceutical (Pvt) Ltd. Karachi.

M/s Kaizen Pharmaceutical (Pvt) Ltd., Karachi requested for registration of following products from the name of M/s Ray Pharam (Pvt) Ltd., to their name. The firm has submitted the dissolution profile of following products. The detail is as under: - Registration Brand Formulation/Gen Date of Renewal S.#. No. Name(s) eric Name Registration Status 1. Serewal Renewal not Quentiapine (as 058267 300mg XR 12.08.2009 submitted by fumarate) 300mg tablet the firm. 2. Renewal Serewal Quentiapine (as submitted 066706 200mg SR 21.09.2010 fumarate) 200mg dated tablet 18.09.2015 3. Renewal Serewel Quentiapine (as submitted 066707 400mg SR 21.09.2010 fumarate) 400mg dated tablet 18.09.2015

The M/s Kaizan has approval for the Tablet section from the Licensing section. Decision: Registration Board deferred the request of firm for product specific inspection of the firm by area FID alongwith the confirmation of the renewal status of product at S.No.1.

Minutes for 254th Registration Board Meeting 26

b. M/s Bosch Pharmaceutical (Pvt) Ltd., Plant–II M/s Bosch Pharmaceutical (Pvt) Ltd., Karachi has requested for transfer of registration from M/s Bosch Pharmaceuticals (Pvt) Ltd., Karachi DML No. 000350 to Bosch Pharmaceutical (Pvt) Ltd., Plant – II Situated at Plot No. 209, Sector 23, Korangi Industrial Area, Karachi having DML No. 000707:

S.# Product for registration with Reg. No. Renewal Remarks generic name up to 1. Cefxone 0.25g Injection 017656 17.07.2020 - Each vial contains: Ceftriaxone (as sodium)…..….250mg 2. Cefxone 0.5g Injection 017657 17.07.2020 - Each vial contains: Ceftriaxone (as sodium)…..….500mg 3. Cefxone 1g Injection 017739 17.07.2020 - Each vial contains: Ceftriaxone (as sodium)………….1g 4. Cefxone 2g Injection 055913 06.04.2019 - Each vial contains: Ceftriaxone (as sodium)………….2g 5. Cefotax 250mg Injection 015130 02.03.2019 - Each vial contains: Cefotaxime (as sodium)……....250mg 6. Cefotax 500mg Injection 015912 19.09.2019 - Each vial contains Cefotaxime Sodium………...…500mg 7. Cefotax 1000mg Injection 015131 02.03.2019 - Each vial contains Cefotaxime (as sodium)…...1000mg 8. Cefazol 0.25g Injection 015901 19.09.2019 - Each vial contains: Cefazolin (as sodium)..……….250mg 9. Cefazol 0.5g Injection 015902 19.09.2019 - Each vial contains Cefazolin (as sodium)………...500mg 10. Cefazol 1G Injection 015903 19.09.2019 - Each vial contains Cefazolin (as sodium)……...1000mg 11. Cefrinex 250mg Injection 015127 02.03.2019 Not in Each vial contains UK/US Cephradine USP……………..250mg (USP Specification) 12. Cefrinex 500mg Injection 015128 02.03.2019 Not in

Minutes for 254th Registration Board Meeting 27

Each vial contains UK/US Cephradine USP………………500mg (USP Specification) 13. Cefrinex 1000mg Injection 015129 02.03.2019 Not in Each vial contains UK/US Cephradine USP……………1000mg (USP Specification) 14. Ceprazone 0.25g Injection 022970 06.01.2018 - Each vial contains: Cefoperazone (as Sodium)...... 250mg 15. Ceprazone 0.5g Injection 019245 23.04.2016 - Each vial contains: Cefoperazone (as Sodium)……500mg 16. Ceprazone 1g Injection 0129246 23.04.2016 - Each vial contains Cefoperazone (as Sodium)…..1000mg 17. Fortazim 0.25g Injection 025112 30.08.2019 - Each vial contains Ceftazidime (as Pentahydrate with sodium carbonate)……………250mg 18. Fortazim 0.5g Injection 025113 30.08.2019 - Each vial contains Ceftazidime (as Pentahydrate with sodium carbonate)……………500mg 19. Fortazim 1g Injection 025114 30.08.2019 - Each vial contains Ceftazidime (as Pentahydrate with sodium carbonate)…………1000mg 20. Zecef 0.25g Injection 026199 18.09.2020 - Each vial contains Cefuroxime (as Sodium)……250mg 21. Zecef 0.75g injection 025111 30.08.2019 - Each vial contains Cefuroxime (as Sodium)……750mg 22. Zecef 1.5g injection 026896 11.05.2016 - Each vial contains Cefuroxime (as Sodium)……1500mg 23. Ivcef 250mg Injection 027733 07.11.2017 Not in Each vial contains UK/US Cefpirome Sulphate…….250mg 24. Ivcef 500mg Injection 027734 07.11.2017 Not in Each vial contains UK/US Cefpirome Sulphate……500mg

25. Ivcaf 1000mg Injection 027735 07.11.2017 Not in Each vial contains UK/US

Minutes for 254th Registration Board Meeting 28

Cefpirome Sulphate…….1000mg 26. Tezox 250mg Injection 034859 07.12.2019 - Each vial contains Cetizoxime (as sodium) USP…..250mg 27. Tezox 500mg Injection 034852 07.12.2019 - Each vial contains Ceftizoxime (as sodium) USP……500mg 28. Tezox 1000mg Injection 034853 07.12.2019 - Each vial contains Ceftizoxime (as sodium) USP…...1000mg 29. Cebac 1g Injection 037630 08.03.2020 - Each vial contains Cefoperazone (as sodium) ……500mg Sulbactam (as sodium) ……..500mg 30. Cebax 2g Injection 037631 08.03.2020 - Each vial contains Cefoperazone (as sodium) …..1000mg Sulbactam (as sodium) ……..500mg 31. Nuxipim 500mg Injection 044356 15.11.2016 - Each vial contains Cefepime (as hydrochloride)…500mg 32. Nuxipim 1g Injection 044355 15.11.2016 - Each vial contains Cefepime (as hydrochloride)...1000mg

Decision: Registration Board decided as follows:

 Cancellation of registrations of products except at S. No. 11, 12, 13, 23, 24 and 25 from M/s Bosch-I (Pvt) Ltd., Karachi.  Registration of products except at S. No. 11, 12, 13, 23, 24 and 25 in the name of M/s Bosch-II (Pvt) Ltd., Karachi. For products at S.No.1-4, firm will select either IM or IV. The Registration Board authorized its Chairman for issuance of registration letters after comments / fixation of MRP by Cost & Pricing Division.  Products at S. No. 11, 12, 13, 23, 24 and 25 were deferred for confirmation of approval status by the reference drug regulatory authorities.

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c. Registration from M/s Surge to M/s Nabiqasim M/s Nabiqasim Industries (Pvt) Ltd., Karachi has requested for transfer of registration of following products from M/s Surge Laboratories to their name. The M/s Nabiqasim have the Tablet (General) section as per GMP issued for export purpose. S.No. Registration No. Product name & composition Renewal upto 1. 028630 Reline tablet 50 mg 26 April, 2017 Each film coated tablet contains: Sertraline HCl…. 50 mg 2. 028631 Reline tablet 100 mg 26 April, 2017 Each film coated tablet contains: Sertraline HCl…. 100 mg

Decision: Registration Board decided as follows:

 Cancellation of registrations of products at S. No. 1 and 2 from M/s Surge Laboratories, Lahore.  Registration of products at S. No. at S. No. 1 and 2 in the name of M/s Nabiqasim Industries (Pvt) Ltd., Karachi. The Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.

d. Registration from M/s Indus to M/s CKD.

M/s CKD have applied for transfer of following products from M/s Indus to their name:

S/N. Name of Drug & Pack size & Remarks composition MRP demanded 1 Nixpro 40 mg Capsule 1.Form-5 The product has Each capsule contains: 2.Fast Track renewal status Pantoprazole (as sodium 3.10’s upto sesquihydrate enteric 4.As per PRC 12.12.2018 coated pellets)……40 mg 5.11-06- (Manufacturer’s 2013/1198. Specifications) Rs.60,000/-

The Licensing division has regularized their Capsule section on 03.12.2014. The firm has submitted the stability studies & GMP. But original GMP & COA is missing. Futher,the formulation is not registered in FDA & UK. Instead it is approved in FDA & UK as delayed release Tablets.

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Decision: Registration Board deferred the request of firm for confirmation of formulation status in the reference regulatory authorities.

e. Transfer of registration from Abbott and contract manufacturing from Mass Pharma

M/s Indus Pharma have applied for registration of following formulation from M/s Abbott to their name & for contract manufacturing from M/s Mass Pharma has the manufacturing facility of Topical / Lotion (non-steroidal) as per renewal inspection report dated 17.03.2015.

S/N. Registration Name of Drug & composition Pack size & Remarks about No. MRP renewal status demanded 1 007076 Eryderm Lotion 60 ml bottle The applicant has Each ml contains: provided last renewal Erythromycin ……..20 mg dated 30.04.2009. After that the firm applied for transfer of product from M/s Abbott on 23.05.2012 which was not approved by the Registration Board in its 234 meeting for not possessing the manufacturing facility. Now, the firm has again applied on 21.05.2014 for transfer from Abbott & contract manufacturing from M/s Mass pharma alongwith fee of Rs.50,000/-, agreement & other codal requirements.

Decision: Registration Board decided as follows:

 Cancellation of registration of Eryderm Lotion, Registration No. 007076 from M/s M/s Abbott Laboratories, Karachi.  Registration of Eryderm Lotion, Registration No. 007076 in the name of M/s Indus Pharma, Karachi and contract manufacturing by M/s Mass Pharma, Lahore. The

Minutes for 254th Registration Board Meeting 31

Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.

Case No. 15 Permission for manufacturing of drug at own site. a. M/s OBS Pakistan (Pvt) Ltd., Karachi Registration Board in it’s 249th meetings deferred request of M/s OBS Pakistan (Pvt) Ltd., Karachi for for permission to manufacturing at its own site for securitization as per checklist approved by Registration Board. Previously, the product was approved for contract manufacturing from M/s Highnoon, Lahore. S.# Name of Product Regn No. Current Proposed Manufacturing manufacturing site site 1. Ovafin 50 tablet 019173 M/s Highnoon OBS, Pakistan Each tablet contains: Laboratories, (Pvt) Ltd., C-14, Clomifene Citrate 17.5.K.M. S.I.T.E, Karachi Multan Road Lahore

Decision: Registration Board approved request of the firm for manufacturing of Ovafin 50 tablet, Registration No. 019173 at its own manufacturing site i.e. M/s OBS Pakistan (Pvt) Ltd., Karachi. b. M/s Semos Pharma, Karachi. M/s Semos Pharma have applied for manufacturing at its own manufacturing site. The Licensing Division has approved the Capsule (Cephalosporin) section 12, Oct, 2014. Their previous contract manufacturing permission was valid till 30.06.2015. 1) Semos Pharma, 057779 Seaxim 400mg Capsule (Pvt) Ltd., KHI Each capsule contains: Cefixime as trihydrate………400 mg 2) -do- 057780 Seaxime Dry Suspension Each 5ml contains: Cefixime as trihydrate…100 mg 3) -do- 057781 Seaxime DS Dry Suspension Each 5ml contains: Cefixime as Trihydrate…200 mg

Decision: Registration Board approved request of the firm for manufacturing of above products at its own manufacturing site i.e. M/s Semos Pharma., Karachi.

Minutes for 254th Registration Board Meeting 32

c. M/s High-Q Pharmaceutical, Karachi.

M/s High Q Pharmaceutical Karachi have applied for permission for manufacturing of following products at its own site. Previously these were manufactured at M/s Medicaids and M/s Novamed. S.No. Applicant Existing Reg. Name of Drug(s) & Date of contract No. Composition application, Manufacturer Diary No. 1) -do- Novamed 061181 Dayline 500mg I.M Inj. 02.07.2015 Lahore Each vial contains: 354 Ceftriaxone as Rs. 50,000/- Sodium…………..500 01.07.2015 mg 2) -do- -do- 061173 Day Fort 1gm Injection 02.07.2015 Each vial contains: 355 Ceftazidime as Rs. 50,000/- Pentyahydrate….1gm 01.07.2015 3) -do- Medicaids Pak, 061176 Mixel 100mg/5ml Dry 26.06.2015 Ltd., Karachi. Suspension 356 Each 5ml contains: Rs. 20,000/- Cefixime……100 mg 25.06.2015

4) -do- Novamed 061180 Dayline 250mg I.M Inj. 26.06.2015 Lahore Each vial contains: 361 Ceftriaxone as Rs. 20,000/- Sodium…..250 mg 25.06.2015 5) -do- -do- 061169 Q-Bact 1gm Injection 26.06.2015 Each vial contains: 351 Cefoperazone as Rs. 20,000/- Sodium……500mg 25.06.2015 Sulbactum as sodium,…500mg 6) -do- Medicaids Pak 061170 Q-Bact 2gm Injection 26.06.2015 Ltd., Karachi. Each vial contains: 352 Cefoperazone as Rs. 20,000/- Sodium………1 gm 25.06.2015 Sulbactum as sodium,..1g 7) -do- Novamed 061182 Dayline 1g I.V Inj. 26.06.2015 Lahore Each vial contains: 353 Ceftriaxone as Rs. 20,000/- Sodium……..1gm 25.06.2015 8) -do- Medicaids Pak, 061179 Mixel 200mg Capsule 26.06.2015 KHI Each capsule contains: 359 Cefixime….200 mg Rs. 20,000/-

Minutes for 254th Registration Board Meeting 33

25.06.2015 9) -do- Medicaids Pak, 061171 Day Fort 250mg 26.06.2015 KHI Injection 362 Each vial contains: Rs. 20,000/- Ceftazidime as 25.06.2015 Pentyahydrate.250mg 10) -do- -do- 061167 Jataxime Injection 26.06.2015 Each vial contains: 350 Cefotaxime as Rs. 20,000/- Sodium……500 mg 25.06.2015 11) -do- -do- 061175 Daypime 1g Injection 26.06.2015 Each vial contains: 357 Cefepime as Rs. 20,000/- Hydrochloride with 25.06.2015 sterile arginine…1g 12) -do- -do- 061168 Jataxime Injection 26.06.2015 Each vial contains: 358 Cefotaxime as Rs. 20,000/- Sodium……1000 mg 25.06.2015 13) -do- -do- 061177 Mixel 200mg/5ml Dry 26.06.2015 Suspension 349 Each 5ml contains: Rs. 20,000/- Cefixime……….200 mg 25.06.2015 14) -do- -do- 061166 Jataxime Injection 26.06.2015 Each vial contains: 345 Cefotaxime as Rs. 20,000/- Sodium…………250 mg 25.06.2015 15) -do- -do- 061172 Day Fort 500mg 26.06.2015 Injection 346 Each vial contains: Rs. 20,000/- Ceftazidime as 25.06.2015 Pentyahydrate.500mg 16) -do- -do- 061174 Daypime 500mg 26.06.2015 Injection 347 Each vial contains: Rs. 20,000/- Cefepime as 25.06.2015 Hydrochloride with sterile arginine.500mg 17) -do- -do- 061178 Mixel 400mg Capsule 26.06.2015 Each capsule contains: 348 Cefixime….400 mg Rs. 20,000/- 25.06.2015 Decision: Registration Board approved request of the firm for manufacturing of above products at its own manufacturing site i.e. M/s High-Q Pharmaceutical, Karachi except item at S.No.16 for confirmation of approval status by the reference drug regulatory authorities.

Minutes for 254th Registration Board Meeting 34

Case No. 16 Registration of drugs after change of title of the firm. a. M/s Martin Dow Ltd, Karachi. M/s Martin Dow Ltd, Karachi has informed that the Licensing Board in its 235th meeting has approved the change of company name from M/s Martin Dow Pharmaceutical Ltd, Karachi to M/s Martin Dow Ltd., Karachi DML No. 000267. The firm has therefore, applied for transfer of registrations on form – 5 of following products to their new title:

S.# Regn. Product name Renewal up to Remarks No. 1. 011231 Dormicum Tablet 7.5mg 28.06.2020 Each film coated tablet contains: Midazolam (USP)…7.5mg (MD Specs) 2. 000576 Mogadon tablet 5mg 28.06.2020 Each film coated tablet contains: Nitrazepam (BP)…..5mg (BP Specs) 3. 001043 Lexotanil tablet 3mg 28.06.2020 Each tablet contains: Bromazepam.3mg BP Specs)

In support the firm has submitted following documents: 1) Required fee as per relevant SRO Rs. 20,000/- for each product. 2) Application on form -5 3) Copy of registration letter/renewal status. 4) Copy of NOC for CRF clearance. 5) Approval of new name/title from CLB 6) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.

Decision: Keeping in view decision in 246th meeting, Registration Board approved registration of above three products in name of M/s Martin Dow Ltd, Karachi.

b. M/s Searle Pakistan Ltd, Karachi. M/s Searle Pakistan Ltd, Karachi was granted Drug Manufacturing License vide No.000016 (Formulation) at F-319, SITE, Karachi. Later on, the title of the company was changed to M/s The Searle Company Ltd. Resultantly, the firm has requested for transfer of their

Minutes for 254th Registration Board Meeting 35

following registered drugs from previous name i.e., M/s Searle Pakistan Ltd, Karachi to new name i.e., M/s The Searle Company Ltd, Karachi as per following details.

Brand Formulation / Date of S. No. Reg. No. Renewal Status Name(s) Generic Name registration Adronil Ibandronate sodium 18/4/2013 1. 075870 3mg/3ml eq. to Ibandronate Not yet due

Injection acid 3mg/3ml Received Alcorib 02/1/2008 Renewal 2. 047385 Ribavirin 400mg Tablets application 01-01-2013 Received Renewal Alcorib 02/1/2008 3. 047386 Ribavirin 500mg application Tablets 01-01-2013

Received Alcorib 02/1/2008 Renewal 4. 047387 Ribavirin 600mg Tablets application 01-01-2013 Received 02/1/2008 Renewal 5. 047388 Alcorib Syrup Ribavirin 50mg/5ml application 01-01-2013 Hydrochlorothiazide Aldactazide 50 valid up to 6. 007726 50mg & 12/11/1984 Tablet 19/10/2014 Spironolectone 50mg Received Renewal Aldactone 100 7. 003203 Spironolectone 100mg 10/12/1977 application Tablet 07-11-2012

Received Aldactone-A Renewal 8. 000017 Spironolectone 25mg 19/3/1976 Tablet application 03-03-2011 Imiquimod 12.5mg Aldara 5% 9. 052222 02/9/2009 Not yet due Cream (Imported drug) transfer of Alpent Flupentixol Deconate registration 10. 053340 15/12/2008 Injection 20mg/2ml applied on 6/12/2013

Minutes for 254th Registration Board Meeting 36

transfer of Alpent Flupentixol Deconate registration 11. 053341 15/12/2008 Injection 100mg/ml applied on 6/12/2013 4/4/1996 page 27 (a) Alprazolam 0.5 mg 3/10/2005 valid up to 12. 018970 Alprox Tablet Transfer of 21/7/2015 (Imported drug) registration from IBL to Searle Rasagiline as 13. 070418 Alzilo Tablets 21/4/2011 Not yet due Mesylate 0.5mg Rasagiline as 14. 070419 Alzilo Tablets 21/4/2011 Not yet due Mesylate 1mg transfer of registration Anzica Tranxemic Acid 15. 053343 15/12/2008 applied on injection 250mg/5ml 6/12/2013

Omeprazole enteric 12/02/2011 Anzo 20 16. 067111 coated pellets eq to 29/11/2010 change of brand Capsules omeprazole 20mg name Omeprazole enteric 12/02/2011 Anzo 40 17. 067112 coated pellets eq to 29/11/2010 change of brand Capsules omeprazole 40mg name Ascorel 07/4/2011 18. 067557 Prasugrel HCl 5mg Not yet due Tablets Ascorel 07/4/2011 19. 067558 Prasugrel HCl 10mg Not yet due Tablets Received Renewal 05/8/2002 20. 028394 Athenil Tablets Simvastatin 10mg application

29-08-2012

Received Renewal 05/8/2002 21. 028395 Athenil Tablets Simvastatin 20mg application

29-08-2012

transfer of Atrium Atraccurium Besylate registration 22. 053342 15/12/2008 Injection 10mg/ml applied on 6/12/2013

Minutes for 254th Registration Board Meeting 37

Received Zofenopril Calcium Renewal 23. 045165 Bifril Tablet 28/2/2007 30 mg application 01-01-2012 09/10/1997 transfer of Registration from import to local manufacture 2/7/1999 toll manufacturing permission for two years

Biocef 15/7/1993 29/08/2001 24. 013504 Cephradine 250mg Injection extension in toll manufacturing for two years 23/10/2003 extension in toll manufacturing for 5 years

25/03/2010 extension in toll manufacturing up to 30-06- 2010 09/10/1997 transfer of Registration from import to local manufacture

Biocef 15/7/1993 2/7/1999 25. 013505 Cephradine 500mg Injection toll manufacturing permission for two years

29/08/2001 extension in toll manufacturing

Minutes for 254th Registration Board Meeting 38

for two years

23/10/2003 extension in toll manufacturing for 5 years

25/03/2010 extension in toll manufacturing up to 30-06- 2010 09/10/1997 transfer of Registration from import to local manufacture

2/7/1999 toll manufacturing permission for two years

Biocef 15/7/1993 29/08/2001 26. 013506 Cephradine 1gm Injection extension in toll manufacturing for two years

23/10/2003 extension in toll manufacturing for 5 years

25/03/2010 extension in toll manufacturing up to 30-06- 2010 Received 09/10/1997 Renewal transfer of application 27. 013507 Biocef Capsule Cephradine 250mg registration 15-07-2013 from import to local

Minutes for 254th Registration Board Meeting 39

manufacture

page 63-64 transfer of Received registration Renewal 28. 013508 Biocef Capsule Cephradine 500mg from import to application local 15-07-2013 manufacture 09/10/1997 Received Biocef Cephradine 26/6/1999 Renewal 29. 024917 Suspension 125mg/5ml application 25-05-2009 Received Biocef Cephradine 26/6/1999 Renewal 30. 024918 Suspension 250mg/5ml application 25-05-2009 09/10/1997 transfer of registration from import to local Biozolin 15/7/1993 31. 013501 Cephazoline 250mg manufacture Injection

Received Renewal application 15-07-2013 09/10/1997 transfer of registration from import to local Biozolin 15/7/1993 32. 013502 Cephazoline 500mg manufacture Injection

Received Renewal application 15-07-2013

Minutes for 254th Registration Board Meeting 40

09/10/1997 transfer of registration from import to local Biozolin 15/7/1993 33. 013503 Cephazoline 1gm manufacture Injection

Received Renewal application 15-07-2013 Received Alendronate Sodium 25/6/2007 Renewal 34. 045428 Bonfit Tablets eq. to Alendronic acid application 10mg 28-06-2012 Received Alendronate Sodium 25/6/2007 Renewal 35. 045429 Bonfit Tablets eq. to Alendronic acid application 70mg 28-06-2012 transfer of 22/5/1984 registration 36. 007276 Calan Tablet Verapamil 120mg applied on 6/12/2013 Renewed up to 25/4/2014 25/4/1984 transfer of 37. 007309 Calan Tablet Verapamil 40mg registration applied on 6/12/2013 Renewed up to 22/4/2014 transfer of 22/5/1984 38. 007310 Calan Tablet Verapamil 80mg registration

applied on 6/12/2013

Received Calan SR 08/5/1988 Renewal 39. 009773 Verapamil 240mg tablets application 29-04-2013 Received Colril 4mg 15/6/2005 Renewal 40. 039261 Thiocolchicoside 4mg Capsule application 17-05-2010 Co-Olesta Olmesartan20mg, 01/8/2009 41. 058022 Not yet due Tablets Hydrochloroththiazide

Minutes for 254th Registration Board Meeting 41

12.5mg

Olmesartan40mg, Co-Olesta 01/8/2009 42. 058023 Hydrochloroththiazide Not yet due Tablets 12.5mg 14/6/1994 transfer of registration from M/s Sterling products Danocrine 08/2/1981 Pakistan to M/s 43. 005753 Danazol 200mg Capsules Searle

Received Renewal application 25-05-2009

14/6/1994 transfer of registration from Sterling products Pakistan to Danocrine 26/5/1981 44. 005921 Danazol 100mg Searle Capsules

Received Renewal application 25-05-2009

transfer of registration Defnac Diclofenac Sodium 45. 053338 15/12/2008 applied on Injection 75mg/3ml 6/12/2013 (page 1/Corr) Diclofenac Sodium 31/8/2010 46. 061875 Defnac Tablets Not yet due 50mg Diclofenac Sodium 31/8/2010 47. 061876 Defnac Tablets Not yet due 75mg Defnac SR Diclofenac Sodium 48. 067110 29/11/2010 Not yet due Tablets 100mg

Minutes for 254th Registration Board Meeting 42

4/2/2006 change of brand name

Duogab 49. 039684 Gabapentin 300mg 01/12/2005 Received Capsules Renewal application 10-01-2011 4/2/2006 change of brand name

Duogab 50. 039685 Gabapentin 400mg 01/12/2005 Received Capsules Renewal application 10-01-2011 4/2/2006 change of brand name

Duogab 51. 039683 Gabapentin 100mg 01/12/2005 Received Capsules Renewal application 10-01-2011 Received Ezebrix Renewal 52. 035903 Ezetimibe 10mg 30/12/2004 Tablets application 27-10-2009 7/2/2005 change of brand name from nexol to Esomeprazole ezium Ezium 20 magnesium 22.5% 53. 035621 30/12/2004 Received Capsules pellets eq to Renewal esomeprazole 20mg application 10-02-2010

7/2/2005 change of brand name Esomeprazole from nexol to Ezium 40 magnesium 22.5% ezium 54. 035622 30/12/2004 Capsules pellets eq to Received esomeprazole 40mg Renewal application 10-02-2010 Received Fenogal Fenofibrate (Ph. Eur) 28/1/2005 Renewal 55. 024095 Capsules 200mg application 28-01-2010

Minutes for 254th Registration Board Meeting 43

Received Glibenclamide HCl Glibomet 28/1/2005 Renewal 56. 036670 2.5mg, Metformin Tablet application HCl 400mg 28-01-2010 Received Pioglitazone(as HCl) Glimp Extra 24/9/2008 Renewal 57. 050733 2mg + Glimipiride Tablets application 30mg 17-09-2013 Received Pioglitazone(as HCl) Glimp Extra 24/9/2008 Renewal 58. 050734 4mg + Glimipiride Tablets application 30mg 17-09-2013 Received Pioglitazone HCl Glimp Plus 2 Renewal 59. 047199 15mg + Glimipiride 22/10/2007 Tablets application 2mg 15-10-2012 Pioglitazone HCl 60. 035857 Glitos Tablet 31/12/2004 15mg Pioglitazone HCl 61. 035858 Glitos Tablet 31/12/2004 30mg Pioglitazone HCl 62. 035859 Glitos Tablet 31/12/2004 45mg Received Pioglitazone HCl eq. Renewal Glitos Plus to Pioglitazone 63. 047393 05/1/2008 application Tablet 15mg+Metformin 08-11-2013 500mg

Received Pioglitazone HCl eq. Renewal Glitos Plus to Pioglitazone 05/1/2008 64. 047394 application Tablet 15mg+Metformin 08-11-2013 850mg

19/2/2011 Gravinate Dimenhydrinate 65. 014408 14/10/1993 transfer of Injection 50 mg/ml registration Paracetamol 500, Received Dextromethorphan Renewal HBr 12.5mg, Hydryllin Anti 07/8/1996 application 66. 019385 Phenylpropanolamine Flu Powder 19-12-2011 HCl 25mg,

Diphenhydramine

16mg

Minutes for 254th Registration Board Meeting 44

Paracetamol 125.0mg, Phenylpropanolamine Hydryllin Anti 67. 024821 HCl 5.0mg, 12/06/1999 Flu Syrup Diphenhydramine HCl 5.0mg Paracetamol 325mg, Received Phenylpropanolamine Renewal Hydryllin Anti HCl 12.5mg, application 68. 020374 04/11/1997 Flu Tablets Diphenhydramine 06-12-2012 8mg HCl, Ascorbic acid 100mg Received Ibuprofen 400mg, Renewal Irofen Forte 13/3/2006 69. 042233 Pseudoephedrine application Tablets 60mg 03-03-2011

Received Ibuprofen 200mg, Renewal 70. 039686 Irofen Tablets Pseudoephedrine 01/12/2005 application 30mg 27-10-2010 Sitagliptin phosphate monohydrate eq. to Jentin Met 18/4/2013 71. 075871 Sitagliptin 50mg, Not yet due Tablets Metformin HCl 1000mg Sitagliptin phosphate monohydrate eq. to Jentin Met 18/4/2013 72. 075872 Sitagliptin 50mg, Not yet due Tablets Metformin HCl 500mg Received Renewal Lamnet 13/3/2006 73. 042248 Lamotrigin 25mg application Tablets 03-03-2011

Received Renewal Lamnet 13/3/2006 74. 042249 Lamotrigin 50mg application Tablets 03-03-2011

Received Renewal Lamnet 13/3/2006 75. 042250 Lamotrigin 100mg application Tablets 03-03-2011

Minutes for 254th Registration Board Meeting 45

Received Lamnet Renewal 76. 053114 Chewable Lamotrigin 5mg 10/11/2008 application Tablets 08-11-2013

Received Levofloxacin Renewal Hemihydrate 09/9/2002 77. 028756 Levoxin Tablet application 256.23mg eq. to 29-08-2012 250mg Levofloxacin

Received Levofloxacin Renewal Hemihydrate 09/9/2002 78. 028757 Levoxin Tablet application 512.46mg eq. to 29-08-2012 500mg Levofloxacin

Received Levofloxacin Renewal Hemihydrate 16/5/2005 79. 039160 Levoxin Tablet application 768.70mg eq. to 29-04-2010 Levofloxacin 750mg

Received Diphenoxylate Renewal hydrochloride2.5mg, 80. 000012 Lomotil Tablet 19/3/1976 application Atropine sulphate 03-03-2011 0.025mg

Lumark Levetiracetam 18/4/2013 81. 075873 Not yet due Injection 500/5ml Received Renewal Metrozine Metronidazole 16/1/1995 82. 018632 application Injection RFU 500mg/100ml 27-11-2010

Received Renewal Morcet 10 Escitalopram (as 13/3/2006 83. 042247 application Tablet oxalate) 10mg 03-03-2011

Received Escitalopram Oxalate Renewal Morcet 20 05/1/2008 84. 047392 25.54mg eq. to application Tablet Escitalopram 20mg 08-01-2013

Received Nezolid 85. 050325 Linezolid 600mg 26/7/2008 Renewal Tablets application

Minutes for 254th Registration Board Meeting 46

23-07-2013

Received Renewal Nezolid 26/7/2008 86. 050326 Linezolid 100mg/5ml application Suspension 23-07-2013

4/1/1978 Received 12/4/1980 Renewal Norpace Disopyramide 87. 005243 change of brand application Capsules Phosphate 100mg name 19-03-2010

Nuberol She Paracetamol 500mg, 88. 073516 12/12/2012 Not yet due Tablets Pamabrom 25mg Received Paracetamol 450mg, Renewal Nubrol Plus Orphenadrine 10/1/2005 89. 036227 application Tablet Citrate35, caffiene 19-01-2010 60mg

Received Renewal Olmesartan 24/9/2008 90. 050735 Olesta Tablets application medoxomil 5mg 23-09-2013

Received Renewal Olmesartan 24/9/2008 91. 050736 Olesta Tablets application medoxomil 20mg 23-09-2013

Received Renewal Olmesartan 24/9/2008 92. 050737 Olesta Tablets application medoxomil 40mg 17-09-2013

Dextrose anhydrous, Renewed upto Peditral Sodium chloride, 27/3/1984 93. 007277 24-05-2014 Powder Potassium chloride,

Sodium bi carbonate Sodium chloride , Potassium chloride, Peditral 94. 067114 Trisodium citrate 29/11/2010 Not yet due Liquid dihydrate, Dextrose, Orange Flavor

Minutes for 254th Registration Board Meeting 47

Sodium chloride , Potassium chloride, Peditral 95. 067113 Trisodium citrate 29/11/2010 Not yet due Liquid dihydrate, Dextrose, Regular Flavor Sodium chloride , Potassium chloride, 96. 067115 Peditral Liquid Trisodium citrate 29/11/2010 Not yet due dihydrate, Dextrose, Bubble gum Flavor Sodium chloride , Potassium chloride, 97. 067116 Peditral Liquid Trisodium citrate 29/11/2010 Not yet due dihydrate, Dextrose, Banana Flavor Sodium chloride, Peditral Low Potassium chloride, 03/5/2010 98. 061351 Not yet due Powder Sodium Citrate, Dextrose Received Renewal Drotaverine HCl 01/6/2005 99. 039262 Relispa Tablets application 40mg 29-04-2010

transfer of Relispa Drotaverine HCl registration 100. 053344 15/12/2008 Injection 40mg/2ml applied on 6/12/2013 31/7/2004 Received 15/09/2004 Renewal corrigendum 101. 033370 Athenil Tablets Simvastatin 40mg application for correction 25-05-2009 in registration

number Received Renewal Relispa Forte Drotaverine HCl 01/6/2005 102. 039263 application Tablet 80mg 29-04-2010

07/9/2009 21/3/2011 Relispa Forte Drotaverine HCl 103. 058489 correction in Not yet due Injection 80mg/4ml registration letter

Minutes for 254th Registration Board Meeting 48

Received Anhydrous Renewal Respro SR Theophyllin in 104. 020375 04/11/1997 application Capsules sustained release 29-04-2010 formulation 300mg

Anhydrous Respro SR Theophyllin in valid up to 105. 020376 04/11/1997 Capsules sustained release 11/7/2016 formulation 200mg 05/1/2008 Received 20/5/2008 Renewal 106. 047389 Rhulef Tablets Leflunomide 100mg change of brand application name 27-05-2013

05/1/2008 Received

Renewal 20/5/2008 107. 047390 Rhulef Tablets Leflunomide 10mg application change of brand 27-05-2013 name

05/1/2008 Received

Renewal 20/5/2008 108. 047391 Rhulef Tablets Leflunomide 20mg application change of brand 27-05-2013 name

Transfer of registration Zulexa Depot Zulcopenthixol 109. 058585 05/10/2009 applied on Injection Deconate 200mg/ml 6/12/2013

Transfer of registration Zulexa Depot Zulcopenthixol 110. 058586 05/10/2009 applied on Injection Deconate 500mg/ml 6/12/2013

Transfer of Diclofenac Sodium registration Rotec-50 111. 053327 50mg+ Misoprostol 04/12/2008 applied on Tablet 200mcg 6/12/2013

Transfer of Diclofenac Sodium registration Rotec-75 16/9/2009 112. 058523 75mg+ Misoprostol applied on Tablet 200mcg 6/12/2013

Minutes for 254th Registration Board Meeting 49

Rizone 113. 058587 Ritodrine HCL 10mg 05/10/2009 Not yet due Injection Received 02/1/2008 Renewal 29/4/2008 114. 047382 Searl-α Tablets Alfacalcidol 0.25mcg application change of brand 29-04-2013 name

Received 02/1/2008 Renewal 29/4/2008 115. 047383 Searl-α Tablets Alfacalcidol 1mcg application change of brand 29-04-2013 name

Received 02/1/2008 Renewal 29/4/2008 116. 047384 Searl-α Tablets Alfacalcidol 0.5mcg application change of brand 29-04-2013 name

13/3/2002 Received 28/10/2003 Renewal Selanz SR permission to 117. 024442 Lansoprozole 30mg application Capsules import 07-02-2012 Lansoprazole

pellets Transfer of registration Serebal 01/4/2009 118. 055611 Mecobalamin 500mcg applied on Injection 6/12/2013

19/3/1976 11/6/2009 Transfer of transfer of registration Serenace 119. 000005 Haloperidol 5mg/ml registration applied on Ampoule from contract 6/12/2013 manufacturing to own facility 19/3/1976 11/6/2009 Received transfer of Renewal Serenace 120. 000006 Haloperidol 1.5mg registration application Tablet from contract 02-03-2011 manufacturing to own facility 19/3/1976 Received Serenace 11/6/2009 Renewal 121. 000007 Haloperidol 0.25 mg Tablet transfer of application registration 02-03-2011

Minutes for 254th Registration Board Meeting 50

from contract manufacturing to own facility Serenace valid up to 122. 003205 Haloperidol 5mg 10/12/1977 Tablet 7/11/2017

Serenace valid up to 123. 003515 Haloperidol 2mg/ml 04/1/1978 Drops 1/1/2018

Serenace valid up to 124. 006363 Haloperidol 10mg 18/5/1982 Tablet 2/4/2017 23/9/1996 Sermol Paracetamol valid up to 125. 018627 26/6/1998 Suspension 120mg/5ml 24/6/2018 change of name 23/9/1996 valid up to 126. 018629 Sermol Tablets Paracetamol 500mg 26/6/1998 24/6/2018 change of name 23/9/1996 Sermol Forte Paracetamol valid up to 127. 018628 26/6/1998 Suspension 250mg/5ml 24/6/2018 change of name 04/9/1998 19/10/2005 Seronil transfer of valid up to 128. 021166 Fluoxetine 20mg Capsules registration 12/7/2015 from IBL to Searle Simbex Simvastatin10mg, valid up to 129. 044048 11/9/2006 Tablets Ezetimibe10mg 27/6/2016 Simbex Simvastatin 20mg, valid up to 130. 044049 11/9/2006 Tablets Ezetimibe10mg 27/6/2016 Simbex Simvastatin 40mg, valid up to 131. 044050 11/9/2006 Tablets Ezetimibe10mg 27/6/2016 14/6/1994 page valid up to 132. 000810 Sosegon Tablet Pentazocine 25mg 284 25/5/2014 14/6/1994 page 286 7/5/1995 toll Sosegon valid up to 133. 002203 Pentazocine 30mg/ml manufacturing Injection 3/10/2014 permission from Geofman page 287 (a)

Minutes for 254th Registration Board Meeting 51

Spiromide 40 Spironolactone 50mg, valid up to 134. 019146 10/4/1996 Tablets Furosemide 40mg 28/3/2016 16/5/1990 25/3/1998 change of Spiromide 50 Spironolactone 50mg, valid up to 135. 011024 formulation Tablet Furosemide 20 mg 014/4/2015 20/11/1990 change of dosage form Sterile water valid up to 136. 022056 for injection WFI 5ml 20/6/1998 24/6/2017 ampoules 14/3/1990 30/5/1991 change of brand name from Sulphamethoxazole Supracombin Cortrimoxin to valid up to 137. 009447 200mg, Trimethoprim Suspension Serebid 27/10/2014 40mg/5ml 18/12/1999 change of name from serebid to supracombin 05/7/1989 30/5/1991 change of brand name from Sulphamethoxazole Supracombin Cortrimoxin to valid up to 138. 010140 400mg, Trimethoprim Tablet Serebid 27/10/2014 80mg 18/12/1999 change of name from serebid to supracombin 14/3/1990 30/5/1991 change of brand name from Sulphamethoxazole Supracombin Cortrimoxin to valid up to 139. 010572 800mg, Trimethoprim Forte Tablet Serebid 22/10/2014 60mg 18/12/1999 change of name from serebid to supracombin 25/10/1993 Suscard buccal 26/4/1995 valid up to 140. 014077 Nitroglycerin 2 mg Tablet transfer of 08/4/2015 registration

Minutes for 254th Registration Board Meeting 52

from IBL to Searle

25/10/1993 26/4/1995 Suscard Buccal transfer of valid up to 141. 014078 Nitroglycerine 5 mg Tablet registration 08/4/2015 from IBL to Searle 26/4/1995 transfer of registration 5/7/1995 permission to import in bulk and local repacking 9/2/2002 extension in permission for bulk import and local repacking Glyceryl trinitrate valid up to 142. 004135 Sustac Tablet 18/3/2003 6.4 mg 19/3/2018 extension in permission for bulk import and local repacking 17/7/2004 extension in permission for bulk import and local repacking 19/3/2008 approval of local manufacturing 26/4/1995 transfer of registration 5/7/1995 Glyceryl Trinitrate permission to valid up to 143. 002992 Sustac Tablet 2.6mg import in bulk 19/3/2018 and local repacking 9/2/2002 extension in

Minutes for 254th Registration Board Meeting 53

permission for bulk import and local repacking 18/3/2003 extension in permission for bulk import and local repacking 17/7/2004 extension in permission for bulk import and local repacking 19/3/2008 approval of local manufacturing 26/11/1986 16/11/1999 Transfer of Tambocor Flecainide acetate valid up to 144. 008671 registration Tablet 100mg 07/11/2014 from shahid Medicos to Searle 31/7/2004 15/09/2004 Cetrizine valid up to 145. 033371 Tarcit Tablet corrigendum dihydrochloride 10mg 25/5/2014 for registration numbers 3/9/1989 27/11/1994 transfer of registration from Impex Tramal plus to Searle valid up to 146. 010170 Tramadol HCl 50mg Capsule 18/8/1996 27/10/2014 transfer of registration from import to local manufacturing 3/9/1989 27/11/1994 Tramal valid up to 147. 010172 Tramadol HCl 100mg transfer of Injection 10/10/2014 registration from Impex

Minutes for 254th Registration Board Meeting 54

plus to Searle

27/7/1999 27/11/1994 Tramadol HCl transfer of valid up to 148. 014049 Tramal Drops 100mg/ml registration 10/10/2014 from Impex plus to Searle Tramal SR valid up to 149. 023317 Tramadol HCl 100mg 03/2/1999 Tablet 23/12/2013 Tranxene Dipotassium valid up to 150. 004071 02/7/1978 Capsule Clorazepate 5mg 10/6/2018 Tranxene Dipotassium valid up to 151. 004072 02/7/1978 Capsule Clorazepate 10mg 10/6/2018 Tranxene Dipotassium valid up to 152. 006570 23/11/1982 Capsule Clorazepate 15mg 07/11/2017 15/9/2006 17/3/2007 valid up to 153. 044082 Uripas Tablet Doxazosin 2 mg change of name 27/6/2016 of oxoso to uripas 15/9/2006 17/3/2007chang valid up to 154. 044083 Uripas Tablet Doxazosin 4mg e of name of 27/6/2016 oxoso to uripas valid up to 155. 044076 Vaptor Tablets Rosuvastatin 10mg 14/9/2006 27/6/2016 valid up to 156. 044077 Vaptor Tablets Rosuvastatin 20mg 14/9/2006 27/6/2016 valid up to 157. 044075 Vaptor Tablets Rosuvastatin 5mg 14/9/2006 27/6/2016 Ventek 10mg valid up to 158. 034665 Montelukast 10mg 23/11/2004 Tablets 19/10/2014 Ventek 4mg valid up to 159. 037703 Chewable Montelukast 4mg 21/3/2005 25/2/2015 Tablets valid up to Fexofenadine HCl 160. 034045 Xadine Tablet 29/9/2004 03/10/2014 60mg page 357 (a)

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Fexofenadine HCl valid up to 161. 034046 Xadine Tablet 29/9/2004 120mg 03/10/2014 Fexofenadine HCl valid up to 162. 034047 Xadine Tablet 29/9/2004 180mg 03/10/2014 Fexofenadine HCl Xadine Plus 60mg, 08/5/2005 page valid up to 163. 039230 Tablet Pseudoephedrine HCl 362 26/4/2015 60 mg transfer of Xicom registration 164. 053339 piroxicam 20mg/ml 15/12/2008 Injection applied on 6/12/2013 Duloxetine HCl Zenbar 20mg enteric coated pellets Valid Up to 165. 055608 01/4/2009 Capsule eq. to Duloxetine 1/4/2014 20mg Duloxetine HCl Zenbar 30mg enteric coated pellets Valid Up to 166. 055609 01/4/2009 Capsule eq. to Duloxetine 1/4/2014 30mg Duloxetine HCl Zenbar 60mg enteric coated pellets Valid Up to 167. 055610 01/4/2009 Capsule eq. to Duloxetine 1/4/2014 60mg Ventek 5mg valid up to 168. 037704 Chewable Montelukast 5mg 21/3/2005 25/2/2015 Tablet Lisinopril Zestoretic-10 dihydrate10mg + Valid Up to 169. 073742 23/1/2013 Tablet Hydrochlorothiazide 23/01/2018 12.5mg Lisinopril dihydrate + Zestoretic-20 valid up to 170. 016791 Hydrochlorothiazide 12/9/1995 Tablet 31/10/2016 20mg + 12.5mg 11/2/2010 1/10/2013 Omixim Cefixime (as Valid Up to 171. 062441 extension in Capsule trihydrate) 400 mg 30/6/2015 contract manufacturing 11/2/2010 1/10/2013 Omixim Cefixime (as Valid Up to 172. 062442 extension in Capsule trihydrate) 200 mg 30/6/2015 contract manufacturing

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11/2/2010 1/10/2013 Omixim Cefixime (as Valid Up to 173. 062443 extension in Suspension trihydrate) 100mg/5ml 30/6/2015 contract manufacturing 11/2/2010 1/10/2013 Omixim DS Cefixime (as Valid Up to 174. 062444 extension in Suspension trihydrate) 200mg/5ml 30/6/2015 contract manufacturing Applied for extension in Ceftriaxone Sodium contract 175. 062438 Tefno Injection 11/2/2010 eq. to Ceftriaxone 1g manufacturing permission on 24/1/2014 Applied for extension in Ceftriaxone Sodium 11/2/2010 page contract 176. 062439 Tefno Injection eq. to Ceftriaxone 402-404 manufacturing 500g permission on 24/1/2014 Applied for extension in Ceftriaxone Sodium contract 177. 062440 Tefno Injection eq. to Ceftriaxone 11/2/2010 manufacturing 250g permission on 24/1/2014 Icimon Isosorbide valid up to 178. 021391 16/05/1998 Capsule mononitrate 20mg 16/5/2018 Icimon Isosorbide valid up to 179. 021392 16/05/1998 Capsule mononitrate 40mg 16/5/2018 valid up to 180. 000538 Inderal Tablets Propanolol 40mg 12/12/1991 31/10/2016 valid up to 181. 000531 Inderal Tablets Propanolol 10mg 12/12/1991 31/10/2016 12/12/1991 23/11/2002 Levamisol valid up to 182. 001318 Ketress Tablets change of name 40MG/5ML 16/7/2017 from Ketrax to Ketress

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12/12/1991 23/11/2002 Levamisol valid up to 183. 001317 Ketress Syrup change of name 40MG/5ML 16/7/2017 from Ketrax to Ketress Etipro SR Omeprazole as SR valid up to 184. 019147 10/4/1996 Capsule microgranules 20mg 11/3/2016 Tenormin valid up to 185. 004396 Atenolol 100mg 12/12/1991 Tablets 31/10/2016 Tenormin valid up to 186. 007167 Atenolol 50mg 12/12/1991 Tablets 31/10/2016 Tenoret Atenolol 50mg + valid up to 187. 009562 12/12/1991 Tablets Chlortalide 12.50mg 31/10/2016 Tenoretic Atenolol 100mg+ valid up to 188. 013564 01/3/1992 Tablets Chlortalide 25mg 16/7/2017 Valid Up to 189. 076022 Tizax Tablets Tizanidine 4mg 19/9/2013 19/9/2018 Valid Up to 190. 076023 Tizax Tablets Tizanidine 2mg 19/9/2013 19/9/2018 Tenormin valid up to 191. 015623 Atenolol 25mg 19/6/1996 Tablets 11/3/2016 valid up to 192. 012350 Zestril Tablets Lisinopril 5mg 29/9/2000 17/5/2015 valid up to 193. 012351 Zestril Tablets Lisinopril 10mg 29/9/2000 17/5/2015 valid up to 194. 012352 Zestril Tablets Lisinopril 20mg 29/9/2000 17/5/2015 16/5/1998 03/4/2009 transfer of Valid Up to 195. 021389 Etizem Tablets Diltazem 30mg registration 3/4/2014 from Getz to Searle 16/5/1998 03/4/2009 transfer of Valid Up to 196. 021390 Etizem Tablets Diltazem 60mg registration 3/4/2014 from Getz to Searle

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25/7/1990 03/4/2009 transfer of registration from Getz to Etizem SR Valid Up to 197. 011381 Diltazem 90mg Searle Tablets 3/4/2014 22/7/2004 approval of import of sustained release pellets

Products registered for Export

S. Brand Name Formulation / Date of Reg. No. Renewal Status No. (s) Generic Name registration Diquin valid up to 1 000326-Ex Nalidix acid 1000mg 25/3/2005 Caplets 23/9/2015 valid up to 2 000327-Ex Diquin Tablets Nalidix acid 500mg 25/3/2005 23/9/2015 Diulactone valid up to 3 000332-Ex Spironolactone 25mg 25/3/2005 Tablets 19/3/2015 Diulactone valid up to 4 000333-Ex Spironolactone 100mg 25/3/2005 Tablets 19/3/2015 Sodium chloride, Potassium Peditral Low valid up to 5 001218-EX chloride,Sodium 20/4/2009 Powder 20/4/2014 Citrate, Dextrose ORS Drotaverine HCl valid up to 6 000331-Ex Relispa Tablets 25/3/2005 40mg 19/3/2015 Relispa Drotaverine HCl valid up to 7 000329-EX 25/3/2005 Injection 40mg/2ml 19/3/2015 Relispa Forte Drotaverine HCl valid up to 8 000330-EX 25/3/2005 Tablet 80mg 19/3/2015 Diquin Nalidix acid valid up to 9 000328-Ex 25/3/2005 Suspension 250mg/5ml 9/3/2015 valid up to 10 003507-EX Serlev Tablets Levofloxacain 250mg 8/8/2012 8/8/2017

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valid up to 11 003508-EX Serlev Tablets Levofloxacain 750mg 8/8/2012 8/8/2017

Decision: Registration Board deferred request of the firm for confirmation of renewal status and approval of above products / formulations by the reference drug regulatory authorities.

Case No. 17 Intimation for discontinuation of production of their marketed product: Valtra (Mirtazapine) Tablet 30mg

M/s Getz Pharma, Karachi has intimated that under Rule 30 of Drug (Licensing, Registering and Licensing) Rules, 1976which states to intimate Registration Board about the circumstance which may lead to reduction in the production of drug and may result in its shortage. This is for information that Valtra (Mirtazapine) Tablets 30mg is their registered and marketed product. Market demand of Mirtazapine deceased drastically in last two years not only in Pakistan but globally because of the discoveries of new antidepressant molecules with better safety profile. The demand is far lesser than the minimum batch quantity of said product which can be manufactured on the equipment, they tend to rely on proviso of rule 30(5) of Drugs Licensing, Registering & Advertising) Rules, 1976. On the basis of the reason mentioned above they will no longer be able to continue the production of Valtra (Mirtazapine) tablet 30mg and this letter is intimation of Registration Board as required. Decision: Registration Board deferred the request of the firm for assessment of the case in term of availability of drug within the country and status of the product in reference drug regulatory authorities.

Case No. 18: Approved registration application

Registration Board in its 238th meeting discussed registration of following product of M/s PharmaEvo, Karachi and decided as recorded in last column. 26. M/s Desven XR 50mg Tab. 14’s Rs.2400.00 Approved. PharmEvo, Each extended release 28’s Rs.4600.00 The Board (Pvt) Ltd, tablet contains: advised firm to Karachi. Desvenlafaxine……50mg provide comparative dissolution profile with originator brand and related

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documents before issuance of registration letter.

Now the firm has submitted the comparative dissolution profile with the brand leader.

Decision: Registration Board approved request of firm for registration of above product (Desven XR 50mg Tablet).

Case No. 19: Correction in composition of approved products. Registration Board in its 249th meeting approved registration of following products of M/s PharmEvo, Karachi and decided as recorded in last column.

Product Name & Composition Pack Demanded Decision Size price Osien D Granules for Suspension 60ml Rs. 330/- Registration Board Each 5ml contains” approved above Ossien Mineral Complex 830 mg products for Vitamin D3…..400IU registration. (Anti Osteoporotic) Osien D Tablet 20’s Rs. 680/- Registration Board Each tablet contains approved above Ossien Mineral Complex 830 mg products for Vitamin D3…..400IU registration. (Anti Osteoporotic)

But the registration letter to the firm could not be issued due to incomplete composition. Now, the firm has clarified the same as under:

Product Name & Composition Pack Size Demanded price Osien D Granules for Suspension Each 60ml Rs. 330/- 5ml contains” Each 5ml contains:- Ossien Mineral Complex (Hydroxy Apatite) 250mg Corresponding to

Calcium ………………….53.5mg Phosphorous ……………..28.4mg

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Residual Mineral Salts ……7.5mg Collagen ………………….67.5mg Other Proteins …………… 20mg Trace elements F1,Mg,Zn,Fe,Cu & Ni) corresponding to approx. 132 mg Hydroxyapatite

Vitamin D3(Cholecalciferol)…..400 IU (equivalent to 0.01 mg) (Anti Osteoporotic) Osien D Tablet 20’s Rs. 680/- Each tablet contains Ossien Mineral Complex 830 mg (Hydroxy Apatite) Corresponding to

Calcium …………. ………177.6mg Phosphorous ……………… 82.2mg Residual Mineral Salts …….24.9mg Collagen ………………..….224 mg Other Proteins …………..…66.1 mg Trace elements Fl,Mg,Zn,Fe,Ni,Cu) Corresponding to approximate 440 mg of Hydroxyapatite

Vitamin D3(Cholecalciferol)…..400 IU (equivalent to 0.01 mg) (Anti Osteoporotic)

Decision: Registration Board approved the correction in the formulation for registration of above products. Case No.20 Deferred cases. a) Registration Board in its 227th meeting approved registration of following products of M/s PharmaEvo, Karachi. Urex 120mg Tablet 1x10’s Rs.8250.00 Approved Each tablet contains:- Febuxostat ……………….120mg (Anti gout)

The firm has informed that the registration letter of above product is still pending till to date. The Febuxostat 120mg strength is available in UK / BNF. Decision: Registration Board approved request of firm for registration of above product (Urex 120mg Tablet).

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b) Registration Board in its 227th meeting approved registration of following products of M/s PharmaEvo, Karachi. Enliv Suspension 240ml Rs.2800.00 Approved Each 5ml contains:- Linezolid …..………..…..100mg (Anti Infective)

The firm has informed that the registration letter of above product is still pending till to date. The Linezolid 100mg strength is available in BNF.

Decision: Registration Board approved request of firm for registration of above product (Enliv Suspension).

c) Registration Board in its 239th meeting deferred registration of following products of M/s

Barrett Hodgson Pakitan, Karachi and decided as recorded in last column. 1. Ivabar 7.5mg Tablet 10’s Rs.1950/- 10/07/2013 Deferred for Each film coated tablet contains: 14’s Rs.2730/- Dy. No. 691 i. Submission of Ivabradine Hydrochloride eq. to 28’s Rs.5460/- Form 5D remaining fee. Ivabradine……...7.5mg 56’s Rs.10,920/- Rs. 60,000/- ii. Confirmation (Anti anginal, anti heart failure) Fast track for approval by application USFDA, EMA, regulatory body of Japan or Australia. iii. Expert opinion byBrig. M.H.Najmi, Dr.Shahid Nawaz, PIMS Dr.Ghulam Haider, Shifa International

2. Ivabar 5mg Tablet 10’s Rs.1740/- 10/07/2013 -Do- Each film coated tablet contains: 14’s Rs.2436/- Dy. No. 690 Ivabradine Hydrochloride eq. to 28’s Rs.4872/- Form 5D Ivabradine………...5mg 56’s Rs.9744/- Rs. 60,000/- (Anti anginal, anti heart failure) Fast track application

Now the firm has submitted that:

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1. At the time of application the product was new drug. But now the drug has become me-too as the same has been registered in the name of M/s Genix in M-242 meeting of Registration Board. 2. Confirmation of approval from EMA and TGA. The formulation is also found approved by USFDA. Decision: Registration Board approved request of firm for registration of above products at S.No.1 and 2.

d) Registration Board in its 243rd meeting deferred registration of following products of M/s

Barrett Hodgson Pakitan, Karachi and decided as recorded in last column.

Barizold infusion Rs 450/- Form 5 Me too (Ecasil, of sami Approved. 600mg/300ml Pack of Fast Track Pharmaceuticals Karachi) (Confirmation of Infusion 1’s 1392 dated Inspection of the firm was Liquid particle Each 300ml vial contains 17/07/13 carried out on 14th & 15th counter and TOC Linezolid 600mg 16/07/2013 May 2013 by area FID and availability by Synthetic antibacterial agent as per report the firm has area FID) of oxazolidinone class good facilities for compliance of GMP USP guidelines.

The firm has provided the evidence for the availability of TOC analyzer and installation of liquid particles counter. The firm has requested to consider the above product in the light of Registration Board’s M-248th meeting decision for six month relaxation.

Decision: Registration Board approved request of firm for registration of above product (Barizold infusion 600mg/300ml).

e. Registration Board in 234th meetings deferred following registration application of M/s OBS Pakistan (Pvt) Ltd., Karachi for expert opinion being new formulation:

S.# Name of firm(s) Pack size Demanded price 85. Andrex Gel 1% 5gm Rs.3000/- Each 5 gm contains: 30’s Testosterone …….50 mg (Hormonals)

Now, the firm has informed that they have developed sachet filling area (Hormone) and considering the good manufacturing facility, Sachet filling area (Hormone) has been given

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approval by the CLB. Furthermore, Andrex Gel 1% is approved by different regulatory Authorities of the world including FDA and is available in market in various countries around the world. The firm have provided following with their claim: i) Approval of additional section of Sachet (Hormones) Soft Gel. ii) Evidence of approval of above generic in TGA iii) Approval product in FDA.

Decision: Registration Board approved request of firm for registration of above product (Andrex Gel 1%). f. Registration Board in 236th meeting deferred following products of M/s. Martin Dow, Karachi for reason recorded in last column as follows: 1. Flora Sachet 3gm 10’s Rs.450/- 18-04-2012 Review of Each sachet contains: 20’s Rs.900/- Dy.No.738 formulation Dioctahedral 30’s Rs.1350/- Rs.8000/- by experts smectite………..3 gm Form-5 (Antidiarrheal)

Now, the firm has stated that in 250th meeting of Registration Board the same formulation has been approved by the Board. The firm has requested for registration of above product. Decision: Registration Board approved request of firm for registration of above product (Flora Sachet 3gm). g. Registration Board in 249th meeting deferred following products of M/s. Espoir Pharmaceutical (Pvt) Ltd., Karachi for reason recorded in last column as follows: S/N. Name of Drug & Pack size & Remarks Decision of 249th composition MRP meeting demanded 1 1. Hemel 1.Form-5 1. USP Registration 2. Tablet 2.Fast Track Board discussed 3. Each film coated tablet 3.10’s that panel contains: Ciprofloxcin HCl 4.As per PRC inspected the eq.to Ciprofloxacin USP 5.11-06- firm on ...500mg 2013/1198. 08.05.2014 and 4. Quinolones Antibiotics. Rs.60,000/- recommended that level of compliance may be monitored during active

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production. Thus the Board decided to consider inspection report conducted after 8th May, 2014 in forthcoming meeting for confirming GMP status of the firm. 2 1.Letob 1.Form-5 1. USP -Do- 2.Tablet 2.Fast Track 3. Each f/c tablet contains. 3.10’s Levofloxcin (as 4.As per PRC Hemihydrate) USP eq. to 5.13-06- Levofloxcin.750mg 2013/1236. 4.Quinolones Antibiotics. Rs.60,000/- 3 1.Hemel 1.Form-5 1. USP -Do- 2.Tablet 2.Fast Track 3. Each film coated tablet 3.10’s contains. Ciprofloxacin Hcl 4.As per PRC eq.to Ciprofloxacin 5.11-06- usp...750 mg 2013/1200. 4. Quinolones Antibiotics. Rs.60,000/- 4 1.Hemel 1.Form-5 1. USP -Do- 2.Tablet 2.Fast Track 3. Each film coated tablet 3.10’s contains. Ciprofloxacin 4.As per PRC Hydrochloride eq.to 5.11-06- Ciprofloxacin USP... 250 2013/1199. mg Rs.60,000/- 4. Quinolones Antibiotics.

Now, the firm has submitted an inspection report conducted on 12 Feb, 2015. The inspection report mentions the following recommendation:

1. The overall GMP compliance level during static conditions is rated “Good”. 2. The panel unanimously recommends the resumption of their production activities. 3. It is also recommended that the level of compliance may be monitored during their active production with the permission of the concerned Division.

Decision: Registration Board approved request of firm for registration of above products at S.No.1-4.

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h. M/s Helix Pharma, Karachi has provided the Central Licensing Board’s decision. The CLB in its 239th meeting has approved that: After thorough deliberations and keeping in view the recommendation/decision of Registration board and point of view of stake holders, the Board unanimously decided as under:

1) Steroidal topical preparations like Eye/Ear Drops, Sterile Eye Ointment, External Preparation i.e. Cream/Ointment/Gel, Lotions, Spray/Aerosols, suppositories, vaginal preparation, intra oral preparations, nasal drops etc shall be manufactured in General facility / area subject to following condition. a) Manufacturers shall have segregated dispensing booths, cleaning validation and controls studies for processes and adequate system to minimize the potential risk of cross contamination, b) Commercial marketing of above products shall be allowed by Registration Board after confirmation and verification of conditions as in (1.a.) above.

Registration Baord in its 237th meeting Deferred following product for confirmation of facility required: 1. Fotidex eye drops Each 1ml contains: Moxifloxacin...... 5mg Dexamethasone………1mg

The firm has undertake that they will follow the recommendation/decision of 239th Central Licensing Board meeting regarding the manufacturing of steroidal products they will manufacture their product “Fotidex Eye Drops (Moxifloxacin + Dexamethasone)” in manufacturing area with segregated dispensing booths, cleaning validation and controls studies for processes and adequate system to minimize the potential risk of cross contamination & will submit the same after getting the registration letter before marketing their product. Decision: Rgistration Board deferred the request of the firm for confirmation of status of above formulation in reference drug regulatory authorities.

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i. Registration Board in 237th meeting deferred following product of M/s. Atco Laboratories Limited Karachi for reason recorded in as follows:

Name of product(s) Pack Demanded Date of Decision of Remarks size price submission of Registration application with Board meeting required fee Advacort 0.1% Cream 5gm Rs.95.00 15-10-2010 Deferred for TGA Each gram contains: 10gm Rs.176.00 1781 confirmation of Methylprednisolone 15gm Rs.250.00 Form-5 steroidal Aceponate MS Rs.8000/- manufacturing ………………0.1% w/w Rs.52,000/- facility Atco Spec. 24-1-2013 (Synthetic corticoseteroid)

The firm has stated that as per decision of Registration Board in its 248th meeting held on 18 & 19th March, 2015 that product containing steroidal topical preparations like eye/ear drops, sterile eye ointment, external preparations i.e. cream/ointment/gel, lotions, spray / aerosols, suppositories, vaginal preparation, intra oral preparations, nasal drops etc shall be permitted for manufacturing in general facility/area provided that manufacturers shall have segregated dispensing booths, cleaning validation and control studies for process and adequate system to minimize the potential risk of cross contamination. The firm has submitted an undertaking for complying the above decision of Registration Board & has requested for approval of the registration of above product. Decision: As formulation is TGA approved, thus Registration Board approved request of firm for registration of above product (Advacort 0.1% Cream).

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Case No. 21 Permission for contract manufacturing of imported product.

M/s High-Q International have applied for contract manufacturing of following imported product from M/s Novamed Pharmaceuticals, Lahore. The firm has deposited the fee of Rs.50,000/- for the purpose. M/s Novamed Pharmaceuticals, Lahore possesses approved section for general injection vial (SVP).

S/No. Reg. No. Name of drug(s) & Composition Renewal 1. 014948 Amikaye Initial registration is 19-05-1994 Each 2ml vial contains: Last renewal submitted on 17-03-2014 Amikcin………..500 mg

Decision: Registration Board approved the request of firm for contract manufacturing permission at M/s Novamed Pharmaceuticals, Lahore in the light of rule 20 A of Drugs (L,R & A) Rules, 1976.

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Case No. 22 Cases of extension in contract manufacturing with change of contract manufacturer

S.No. Applicant Existing Proposed Reg. Name of drug(s) & Date of Contract contract contract No. Composition application, permission valid Manufacturer manufacturer Diary No. up till and Registration Board Meeting of previous approval 1. Medicure Envoy Mediate 050412 Bacnel 400mg Capsule 03.08.2015 30.06.2015 Laboratories, Pharmaceutical, Pharmaceutical, Each capsule contains: Dy. No. 1858 Meeting 238th Karachi Multan Lahore. Karachi Cefixime………..400 mg Rs. 50,000/- 03.11.2014 2. -do- -do- -do- 050411 Bacnel 100mg 03.08.2015 -do- Suspension Dy. No. 1858 Each 5ml contains: Rs. 50,000/- Cefixime………..100 mg 03.11.2014

3. High-Q Int’l, Surge Labs, High Q 022645 Hizone Injection 250mg 26.06.2015 -do- Karachi. Sheikhupura Pharmaceuticals IM 363 Each vial contains: Rs. 50,000/- Ceftriaxone as 25.06.2015 Sodium…250mg 4. -do- -do- -do- 018300 Hizone Injection 1gm IV 26.06.2015 -do- Each vial contains: 363 Ceftriaxone as Rs. 50,000/- Sodium…1gm 25.06.2015 5. -do- -do- -do- 014947 Cefapezone Inj. 1gm 26.06.2015 -do- Each Vial Contains: 363 Cefoperazone Rs. 50,000/- Sodium….1gm 25.06.2015 6. High-Q Int’l, Surge Labs, NovaMed, 018501 Remethan Injection 26.05.2015 30.06.2015 Karachi. Sheikhupura Pharmaceutical, 75mg 144 Meeting 243rd

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Lahore Each 3ml contains:- Rs. 20,000/- Diclofenac 26.05.2015 Sodium……….75mg 7 -do- -do- -do- 019467 Cycin 100mg / 50ml 26.05.2015 -do- Injection I.V 146 Each vial contains:- Rs. 20,000/- Ciprofloxacin .100mg 26.05.2015

8 -do- -do- -do- 019468 Cycin 200mg/100ml 26.05.2015 -do- Injection I.V 147 Each vial contains:- Rs. 20,000/- Ciprofloxacin ..200mg 26.05.2015

9. High-Q Int’l, Medicaids, High Q 022647 Dayzone IV 250mg 02.07.2015 30.06.2015 Karachi Karachi Pharmaceuticals Injection 510 Meeting 238th Each vial contains: Rs. 50,000/- Ceftriaxone as 01.07.2015 Sodium……250 mg 10. -do- -do- 022646 Dayzone IV 1g Injection 02.07.2015 -do- Each vial contains: 510 Ceftriaxone as Rs. 50,000/- Sodium……1gm 01.07.2015 11. -do- -do- 022650 Daytaxime IM/IV 250mg 02.07.2015 -do- Inj. 510 Each vial contains: Rs. 50,000/- Cefotaxime as 01.07.2015 Sodium……250mg 12. -do- -do- 022649 Daytaxime IM/IV 500mg 02.07.2015 -do- Inj. 510 Each vial contains: Rs. 50,000/- Cefotaxime as 01.07.2015 Sodium……500mg

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13. -do- -do- 022648 Daytaxime IM/IV 1gm 02.07.2015 -do- Inj. 510 Each vial contains: Rs. 50,000/- Cefotaxime as 01.07.2015 Sodium………1 gm

Decision: Registration Board approved request of the firm for change in contract manufacturer of above products from previous contract manufacturer to newly proposed (as recorded against each item) and extended the permission till 30.06.2020 in the light of rule 20 A of Drugs (L,R & A) Rules, 1976.

Case No. 23 Cases of export registration for extension in contract manufacturing

S.No. Applicant Contract Reg. No. Name of drug(s) & Date of Category Contract permission manufacturer Composition application, valid up till and Diary No. & Registration Board Form Meeting 1. AGP (Pvt) Ltd., M/s AGP 002693-EX Cinklare Capsule 400mg 22.06.2015 Export purpose 30.06.2015 B-23, S.I.T.E. Health Care Each Capsule contains DyNo.1555 Meeting 238th Karachi (Pvt) Ltd., Cefixime…..400mg Rs.20,000/- Karachi 22.06.2015 2. -do- PharmaEvo, 002694-EX Cinklare Suspension 27.08.2015 Export purpose Karachi 200mg 2078 Each 5ml contains: Rs, 50,000/- Cefixime……..200mg 3. -do- -do- 002695-EX Cinklare Suspension 27.08.2015 Export purpose 100mg 2078 Each 5ml contains: Rs, 50,000/- Cefixime……..100mg 4. Merck (Pvt) Ltd., Macter Int’l, 002305-EX Curecef 400mg Capsule 26.06.2015 Export purpose Baluchistan Karachi Each capsule contains: 450 Cefixime ……..400 mg Rs. 20,000/- 5. -do- -do- 002306-EX Curecef 100mg/5ml 26.06.2015 Export purpose Capsule 450

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Each 5ml contains: Rs. 20,000/- Cefixime ……..100 mg 6. -do- -do- 002307-EX Curecef Dry Suspension 26.06.2015 Export purpose 200mg/5ml 450 Each 5ml contains: Rs. 20,000/- Cefixime ……..200 mg 7. -do- -do- 003855-EX Curecef Tablets 200mg 26.06.2015 Export purpose Each tablet contains 450 Cefixime…200mg Rs. 20,000/- 8. Nabiqasim Surge 002182-EX Dexim 8mg / 2ml Injection 03.07.2015 Export purpose Industries Laboratories, Each 2ml contains:- 39 Karachi Sheikhupura Dexamethasone Sodium 03.07.2015 Phosphate eq. to Dexamethasone ………….8mg 9. -do- -do- 002181-EX Gentabact 80mg /2ml 03.07.2015 Export purpose Injection 39 Each 2ml contains:- 03.07.2015 Gentamicin Sulphate USP eq. to Gentamicin base …….80mg 10. -do- -do- 000470-EX Nabica Injection 1gm Export purpose Each vial contains: Ceftriaxone Sodium USP eq to Ceftriaxone…1gm N.Qs Specs 11. -do- -do- 000471-EX Nabica Injection 250mg Export purpose Each vial contains: Ceftriaxone Sodium USP eq to Ceftriaxone…250mt N.Qs Specs 12. -do- -do- 000472-EX Nabica Injection 500mg Export purpose Each vial contains:

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Ceftriaxone Sodium USP eq to Ceftriaxone…500mg N.Qs Specs 13. -do- -do- 000473-EX Refine Injection 75mg/3ml Export purpose Each 3ml ampoule contains: Diclofenac Sodium USP…75mg N.Qs Specs. 14. -do- -do- 000548-EX Revaxim Injection 500mg Export purpose Each vial contains: Cefotaxime (as Sodium Salt) USP….500mg 15. -do- -do- 000547-EX Revaxim Injection 1g Export purpose Each vial contains: Cefotaxime (as Sodium Salt) USP….1gm 16. M/s AGP Karachi M/s PharmEvo 002691-EX Neogene 500mg IV 26.06.2015 Export purpose Kar. Injection 1556 Each vial contains: Rs. 20,000/- Ceftriaxone 22.06.2015 Sodium………….500mg

17. -do- -do- 002692-EX Neogene 1g IV Injection 26.06.2015 Export purpose Each vial contains: 1556 Ceftriaxone Rs. 20,000/- Sodium………….1 gm 22.06.2015

Decision: Registration Board extended contract manufacturing permission of above products for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.

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Registration-III Case No.24: Applications for extension in Contract Manufacturing Permission.

S. No. Name of Applicant Name of Reg. No. Name of drug(s) & Date of Category Date up to which last Contract Composition application, contract manufacturer Diary No. & manufacturing Form permission was valid (Registration Board meeting in which previous approval was granted) 1. Well Care M/s Global 057555 Welxime 100mg Dry 30-06-2015 Extension The Registration Board Pharmaceuticals Pharmaceuticals Suspension Dy.No.1516 approved the extension Sargodha Islamabad Each 5ml contains: Rs.50,000/= till 30-06-2015 in its Cefixime (as 238th meeting with trihydrate)……100mg advise to submit (USP Specifications) remaining fee Rs.8000/=. Which the firm has deposited and also deposited Rs.50,000/= for fresh extension. 2. -do- -do- 057557 Welxime 400mg Capsule 30-06-2015 Extension -do- Each capsule contains: Dy.No.1517 Cefixime (as Rs.50,000/= trihydrate)………400mg (USP Specifications)

3. Well Care M/s Neutro 031980 Rezone 1gm Injection IV 02-01-2014 Extension -do- Pharmaceuticals Pharma, Each vial contains:- Dy.No.441 Sargodha Lahore Ceftriaxone (as sodium Rs.50,000/= salt)……………..1gm (USP Specifications)

4. -do- -do- 031981 Rezone 250mg Injection IV 02-01-2014 Extension -do- Each vial contains:- Dy.No.441 Ceftriaxone (as sodium Rs.50,000/=

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salt)……………..250mg (USP Specifications)

5. -do- -do- 031982 Rezone 500mg Injection IV 02-01-2014 Extension -do- Each vial contains:- Dy.No.441 Ceftriaxone (as sodium Rs.50,000/= salt)……………..500mg (USP Specifications)

Decision: Registration Board approved request of the firm for change in contract manufacturer of above products from previous contract manufacturer to newly proposed (as recorded against each item) and extended the permission till 30.06.2020 in the light of rule 20 A of Drugs (L,R & A) Rules, 1976.

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Case No.25

The Registration Board in 244th meeting deferred the following registration application of M/s. EG Pharmaceuticals, Islamabad for provision of evidence of TOC analyzer & latest GMP inspection report.

6. Amika Injection 500mg Form 5 Amikacin 250mg/ml BNF Deferred for Each 2ml vial contains: Dy No 6805 61 Grasil of Sami provision of Amikacin as dated Pharmaceuticals Karachi evidence of TOC Sulphate……500mg 31/10/13 Inspection of the firm was analyzer & latest (USP Specification) 20,000/- conducted on 26/03/14 by GMP inspection (Aminogylycoside ) As per SRO the DDG (E&M) and area report. FID and certain discrepancies are observed of which the management Inspection has agreed to rectify within Report? one month.

The firm has now submitted inspection report conducted by Federal Inspector of Drug, Islamabad dated 10-03-2015. The inspection report recommends issuance of GMP certificate for export purpose with the direction to improve conditions immediately. The conclusion of report is reproduced as under:-

“The hygienic conditions are maintained except some doors in the injectionn & vial filling room need to be changed. The company want CGMP certificate for export purpose only. This may be issued separately. In the meanwhile company is directed to improve the condition, immediately”.

Further, the Registration Board in 248th meeting decided that the Manufacturer’s already having registrations of liquid injectable dosage forms using water for injection (WFI) will perform test for oxidizable substances as a minimum requirement for compliance of compendial monographs and will install TOC analyzer in 06 months time to comply with requirement of USP for testing of WFI.

Decision: Registartion Board deferred the request of the firm for registration of above product for the latest GMP inspection report since the submitted inspection report dated 10 March, 2015 does not verify the GMP of the manufacturing facility.

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Case No.26

Registration Board in its 241st meeting approved the following products of M/s Rotexmedica Pakistan (Pvt) Ltd, Islamabad. The registration letter could not be issued due to the reason that the product at the Sl.No.2 (Tramadol 100mg tablet) is available as sustained release / extended release dosage form in SRA’s. Later on, the firm deposited Rs.5000/= for correction in the dosage form / description of the product.

S. Name of Name of rugs /label Claim Demanded Demanded Date of Previous No. Firms Pack size Price application Decision & Fee. of 215th & 218th meeting 7. M/s. Rotex Volpan 50mg Capsules 1x10’s As Per 23-12-2008 Deferred for the Medica, Each capsule contains:- SRO Rs.8000/= next meeting Islamabad. Tramadol HCl + for detailed BP……50mg (Non Rs.12,000 discussion alongwith all Narcotic Analgesic) already deferred cases in different meetings. (M-218)

8. M/s. Rotex Volpan 100mg tablets 1x10’s As Per 23-12-2008 -do- (M-215) Medica, Each tablet contains:- SRO Rs.8000/= Islamabad. Tramadol……100mg + (Non Narcotic Analgesic) Rs.12,000

The firm has their requested for grant of registration of above products.

Decision: Registration Board approved the request of the firm for registration of above products with correctin in the label claim / description of drug for the product at S. No. 2 as under:

“Volpan SR 100mg tablets Each sustained release tablet contains:- Tramadol…………….100mg”

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Case No.27

Registration Board in its 234th meeting approved following product of M/s Nimrall Pharmceuticals, Rawat, Islamabad. S.No. Name and Composition of Product Pack size Demanded Price Decision (M-234) 9. Xinia Plus Injection 3mlx5’s Amps As Per SRO Approved Each ml contains:- Diclofenac Sodium…………..25mg Lidocaine Hydrochloride….....20mg

The firm later on pointed out that the above formulation was actually applied for 75mg of Diclofenac Sodium with 20mg Lidocaine hydrochloride instead of above mentioned formulation wherein Diclofenac Sodium is 25mg with 20mg Lidocaine hydrochloride. The stance of firm has been found valid from the original file and the same formulation is registered in the name of M/s Bosch, (Aram), Global, (Articure) & English Pharma (D-Pain). The firm has their requested for grant of registration of above products. Deccision: Registartion Board deferred the case for issuance of registration letter till confirmation of formulation status in the reference drug regulatory authorities.

Case No.28

Registration Board in its 250th meeting approved the following products of M/s Rogen Pharmaceuticals, Rawat for extension in contract manufacture permission. Now, the firms has requested for change of route of administration from IV to IM.

S. Name of Name of Reg. No. Name of Drug(s) & Contract No. Applicant Contract Composition permission valid manufacturer up till and Registration Board Meeting of previous approval 10. M/s Rogen M/s Shawan 072364 Rogzone Injection 500mg IV 30-06-2015 Pharmaceutical Pharmaceutical Each Vial contain:- s Rawat s Rawat Ceftriaxone as Sodium…………..500mg (USP Specifications)

Decision: Registartion Board approved the request of the firm for change in the route of administration of above product from IV to IM.

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Case No.29:

Registration Board in its 250th meeting approved the following products of M/s Ambrosia Pharma , Rawat for extension in contract manufacture permission. Now, the firms has requested for correction in composition since in the minutes of the refereed meeting for capsule dosage form following wrong description was mentioned. “Each 5ml contains”

11. M/s Ambrosia M/s Wise 060956 Maxgard 400mg Capsules 30-06-2015 Pharma (Pvt) Pharmaceutical Each 5ml contains:- Ltd, s Rawat. Cefixime (as Islamabad. Trihydrate)……...400mg

Decision: Registarion Board approved the correction in the description of above product.

Case No.30.

Registration Board in its 250th meeting deferred the following applications for evaluation of case and registration applications. Now the firm has submitted the last permission for contract manufacturing valid up till 30-06-2015. and requested for grant extension in contract manufacturing permission.

S. No. Name of Name of Reg. No. Name of drug(s) & Contract Applicant Contract Composition permission valid up manufacturer till and Registration Board Meeting of previous approval 1. M/s Focus & M/s Bio Labs 054652 Ruzone 250mg Injection IM 30-06-2015 Rulz Pharmaceutical Each vial contains:- (M-239) Pharmaceuticals s (Pvt) Ltd, Ceftriaxone (as sodium (Pvt) Ltd., Islamabad. )………....250mg Islamabad (USP Specs.)

2. -do- -do- 054653 Ruzone 500mg Injection IM 30-06-2015 Each vial contains:- (M-239) Ceftriaxone (as sodium)………..500mg (USP Specs.)

3. -do- -do- 054654 Ruzone 1gm Injection IM 30-06-2015 Each vial contains:- (M-239)

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Ceftriaxone (as sodium)………..1gm (USP Specs.)

4. -do- -do- 054655 Trag 250mg Injection (IV / 30-06-2015 IM) (M-239) Each vial contains:- Cefotaxime (as sodium) ……….250mg (USP Specs.)

5. -do- -do- 054656 Trag 500mg Injection (IV 30-06-2015 /IM) (M-239) Each vial contains:- Cefotaxime (as sodium)……….500mg (USP Specs.)

6. -do- -do- 054657 Trag 1gm Injection (IV / 30-06-2015 IM) (M-239) Each vial contains:- Cefotaxime (as sodium)……….1gm (USP Specs.)

Decision: Registration Board extended contract manufacturing permission of above products (S.No.1-6) for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.

Case No.31:

M/s Ambrosia Pharmaceuticals Rawat, Islamabad have applied for transfer of already registered products of M/s Spencer & Company (Pvt) Ltd., Karachi to their name.

S. No. Reg. No. Name of drug(s) & Pack Size Date of Application Composition 1. 010390 Cardinol 10mg Tablets 5x10’s 30-01-2015 Each film coated tablet Dy.No.167-DDG(R.II) contains:- Rs.20,000/= Propranolol HCl………..10mg (BP Specifications) (Beta-adrenergic blocking agent)

2. 010391 Cardinol 40mg Tablets 5x10’s 30-01-2015

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Each film coated tablet Dy.No.168-DDG(R.II) contains:- Rs.20,000/= Propranolol HCl ………..40mg (BP Specifications) (Beta-adrenergic blocking agent)

3. 010269 Antolol 50mg Tablets 2x10’s 01-06-2015 Each film coated tablet Dy.No.899-DDG(R.II) contains:- Rs.20,000/= Atenolol BP……..50mg (BP Specifications) (Cardio selective beta blocker) 4. 010270 Antolol 100mg Tablets 2x10’s 01-06-2015 Each film coated tablet Dy.No.903-DDG(R.II) contains:- Rs.20,000/= Atenolol BP……..100mg (BP Specifications) (Cardio selective beta blocker) 5. 008149 Inflam 200mg Tablets 50x10’s 01-06-2015 Each film coated tablet Dy.No.901-DDG(R.II) contains:- Rs.20,000/= Ibuprofen ……..200mg (BP Specifications) (Anti-inflammatory agent) 6. 011432 Inflam 600mg Tablets 50x10’s 01-06-2015 Each film coated tablet Dy.No.900-DDG(R.II) contains:- Rs.20,000/= Ibuprofen ……..600mg (BP Specifications) (Anti-inflammatory agent) 7. 012762 Inflam 100mg Suspension 60ml 01-06-2015 Each 5ml contains:- 90ml Dy.No.902-DDG(R.II) Ibuprofen ……..100mg 120ml Rs.20,000/= (BP Specifications) (Anti-inflammatory agent) 8. 004184 Minolad Syrup 120ml 30-01-2015 Each 4ml contains:- Dy.No.169-DDG(R.II) Vitamin A……..2400IU Rs.20,000/= Vitamin D2……..400IU L-Lysine Monohydrochloride..25mg Iron Chloline Citrate………..40mg Calcium Glycerophosphate…20mg Sodium glycerophosphate…...4mg

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Manganese Sulphate………0.2mg Copper sulphate………..….0.2mg Cholline Chloride…….….….1mg Methionine……………….…4m g (Antianaemic + Minerals) 9. 000724 Digeplex Syrup 120ml 01-06-2015 Each 4ml contains:- Dy.No.904-DDG(R.II) Pepsin…………….……10mg Rs.20,000/= Diastasce(1:2000)……..12.5mg Vitamin B1……………..4ml Vitamin B2…………….0.5mg Vitamin B12……….…..2mcg Nicotinamide…………..10mg Alcohol…………………2mg (Enzyme vitamin compound) 10. 014715 Spensid Cough Syrup 60ml 01-06-2015 Each 5ml contains:- 120ml Dy.No.905-DDG(R.II) Dextromethorphan 450ml Rs.20,000/= Hbr……….……10mg Chlorpheniramine Maleate………....2mg Ephedrine Hcl…..7mg (Antitussive)

The firm has their requested for grant of registration of above products.

Decision: Registration Board decided as follows:  Cancellation of registrations of products at S.No. 01-07 from M/s Spencer & Company (Pvt) Ltd. Karachi.  Registration of products at S. No. 01-07 in the name of M/s Ambrosia Pharmaceuticals Rawat, Islamabad. The Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.  Products at S. No. 08, 09 and 10 were deferred for confirmation of approval status by the reference drug regulatory authorities.

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Case No.32:

M/s Alza Pharmaceuticals, Rawalpindi have applied for transfer of following products from Al- Shifa Pharmaceuticals Rawalpindi (Old) premises to New premises at M/s Alza Pharmaceuticals, Al-Shifa Trust Eye Hospital, Jhelum Road, Rawalpindi:-

S. Name of the Reg.No. Brand Name / Label Claim Pack Price Date of Status in No Firm. Size Submission reference drug agencies 1. M/s Alza 019888 Zyline 0.40/1.0% Eye Drops 10ml De- 07-08-2015 - Pharmaceutical Each ml contains:- controlled Dy.No.1672 s, Zinc Sulphate…….4mg Rs.20,000/= Al-Shifa Trust Boric Acid……….10mg Eye Hospital, (Alza’s Specs.) Jhelum Road, (Astringent) Rawalpindi 2. -do- 019889 Demasone Eye Drops 5ml As Per 07-08-2015 - Each ml contains:- SRO Dy.No.1649 Dexamethasone Sodium 471(I)/93 Rs.20,000/= Phosphate 1.093mg eq. to Dexamethasone Phosphate……..……….1mg (USP Specs.) (Corticosteroid) 3. -do- 019890 Demasone-N Eye Drops 5ml De- 07-08-2015 Discontinued Each ml contains:- controlled Dy.No.1666 in USA & Dexamethasone Sodium Rs.20,000/= not found in Phosphate 1.093mg eq. to Uk. Dexamethasone Phosphate…..1mg Neomycin Sulphate eq. to Neomycin Base……………....3.5mg (USP Specs.) (Corticosteroid and antibiotic) 4. -do- 019891 Tearsol Eye Drops 10ml De- 07-08-2015 - Each ml contains:- 15ml controlled Dy.No.1663 Dextran 70…….……1mg Rs.20,000/= Hydroxyprophyl Methylcellulose….`….0.4% (USP Specs.) (Eye Lubricant) 5. -do- 019892 Gentabiotic 3% Eye Drops 5ml As Per 07-08-2015 - Each ml contains:- SRO Dy.No.1641 Gentamycin Sulphate BP…3mg 471(I)/93 Rs.20,000/=

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(USP Specs.) (Aminoglycoside Antibiotic) 6. -do- 019893 Cromolergic 4% Eye Drops 5ml As Per 07-08-2015 - Each ml contains:- SRO Dy.No.1639 Cromoglycate Sodium 471(I)/93 Rs.20,000/= BP…40mg (BP Specs.) (Non steroidal anti-inflammatory drugs (NSAIDs) 7. -do- 019894 Cromolergic 2% Eye Drops 5ml De- 07-08-2015 - Each ml contains:- controlled Dy.No.1654 Cromoglycate Sodium Rs.20,000/= BP…20mg (BP Specs.) (Non steroidal anti-inflammatory drugs (NSAIDs) 8. -do- 019895 Tromid Eye Drops 10ml De- 07-08-2015 - Each ml contains:- controlled Dy.No.1661 Tropicamide……….10mg Rs.20,000/= (USP Specs.) (Anticholinergic) 9. -do- 019897 Predsol 1% Eye Drops 5ml As Per 07-08-2015 - each ml contains:- SRO Dy.No.1657 Prednisolone 471(I)/93 Rs.20,000/= acetate………..10mg (USP Specs.) (corticosteroid) 10. -do- 025683 Naphstine 0.025/0.3% Eye Drops 10ml Rs.20.00 07-08-2015 - Each ml contains:- 15ml Rs.36.00 Dy.No.1667 Naphazoline (as Rs.20,000/= hydrochloride)……0.25mg Pheniramine (as maleate)….3mg (USP Specs.) (Decongestant and Antihistamine)

11. -do- 025684 Balanced Salt Solution 500ml Rs.250.00 07-08-2015 - Each ml contains:- Dy.No.1669 Sodium Rs.20,000/= Chloride…….…….6.4mg Potassium Chloride………0.75mg Calcium Chloride…..…….0.48mg Magnesium Chloride……...0.3mg Sodium

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Acetate………..….3.9mg Sodium citrate………….…1.7mg (Isotonic solution) 12. -do- 025685 Atropin 1% Eye Drops 10ml Rs.12.00 07-08-2015 - Each ml contains:- 15ml Rs.17.00 Dy.No.1642 Atropine Sulphate……….10mg Rs.20,000/= (USP Specs.) (Mydriatics, Cycloplegics) 13. -do- 025686 Alklorafen 0.5/0.4% Eye Drops 10ml Rs.19.00 07-08-2015 Not found in Each ml contains:- 15ml Rs.35.00 Dy.No.1646 USA & UK Chloramphenicol Rs.20,000/= Base…………5mg Hydroxypropylmethylcellulose… ……………..4mg (USP Specs.) (Antibiotic) 14. -do- 025687 Askaine 0.5% Eye Drops 10ml Rs.30.00 07-08-2015 - Ceach ml contains:- 15ml Rs.42.00 Dy.No.1648 Proparacaine hydrochloride Rs.20,000/= ….5mg (USP Specs.) (Local Anesthetic)

15. -do- 025688 Pilostat 2% Eye Drops 10ml Rs.40.00 07-08-2015 - Each ml contains:- Dy.No.1658 Pilocarpine Rs.20,000/= hydrochloride.…20mg (USP Specs.) (Antiglaucoma Drugs) 16. -do- 025689 Methocel Eye Drops 2.25ml Rs.500.00 07-08-2015 - Each ml contains:- Dy.No.1673 Hydroxypropylmethylcellulose..2 Rs.20,000/= 0mg Sodium Chloride………...…6.4mg Potassium Chloride…….…0.75mg Calcium Chloride…………0.48mg Magnesium Chloride………0.3mg Sodium Acetate……………3.9mg Sodium Citrate…………….1.7mg (Alza’s Specs.) (Visocoelastic Gel)

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17. -do- 025690 Al-amide 10% Eye Drops 10ml Rs.9.50 07-08-2015 - Each ml contains:- Dy.No.1659 Sulphacetamide Rs.20,000/= Sodium…….100mg (USP Specs.) (Sulfonamide Antibiotic)

18. -do- 025691 Al-amide 20% Eye Drops 10ml Rs.10.00 07-08-2015 Not found in Each ml contains:- Dy.No.1650 USA & UK. Sulphacetamide Rs.20,000/= Sodium…….200mg (USP Specs.) (Sulfonamide Antibiotic)

19. -do- 025692 Tobralux 0.3% Eye Drops 5ml Rs.60.00 07-08-2015 - Each ml contains:- Dy.No.1660 Tobramycin……….3mg Rs.20,000/= (USP Specs.) (Aminoglycoside Antibiotic)

20. -do- 031204 Shifopin 0.03% Eye Drops 5ml Rs.80.00 07-08-2015 - Each ml contains:- Dy.No.1647 Flurbiprofen Sodium……0.3mg Rs.20,000/= (USP Specs.) (Nonsteroidl Anti-inflammatory)

21. -do- 031206 Cyclocil 1.0% Eye Drops 10ml Rs.90.00 07-08-2015 - Each ml contains:- Dy.No.1655 Cyclopentolate HCl……….10mg Rs.20,000/= (USP Specs.) (Cycloplegic)

22. -do- 031207 Al-Fenac 0.1% Eye Drops 5ml Rs.80.00 07-08-2015 - Each ml contains:- Dy.No. Diclofenac Sodium………1mg 1643 (NSAIDs) Rs.20,000/= 23. -do- 031208 Flobacin 0.3% Eye Drops 5ml Rs.80.00 07-08-2015 - Each ml contains:- Dy.No.1677 Ofloxacin………..3mg Rs.20,000/= (USP Specs.) (Fluroquinolone Antibiotic) 24. -do- 031209 Tetrachrom Eye Drops 10ml Rs.110.00 07-08-2015 Not found in Each ml contains:- Dy.No.1662 USA & UK Sodium Cromoglycate Rs.20,000/= BP……40mg Tetrahydrozoline HCl

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USP….0.5mg (Anti-Allergics) 25. -do- 031210 Shifol 0.5% Eye Drops 5ml Rs.80.00 07-08-2015 - Each ml contains:- Dy.No.1640 Timolol ………5mg as timolo Rs.20,000/= Maleate………….6.8mg (USP Specs.) (Anti-Glucoma Agent)

26. -do- 049229 Shifsone 0.5/0.1% Eye Drops 5ml Rs.20.00 07-08-2015 Not found in Each ml contains:- Dy.No.1652 USA & UK Chloramphenicol……… 5mg Rs.20,000/= Dexamethasone as Sodium Phosphate………….…..1mg (Alza’s Specs.) (Corticosteroid and Antibiotic)

27. -do- 049230 Shifeye 0.3/0.1% Eye Drops 5ml Rs.102.00 07-08-2015 - Tobramycin…………….…..…3 Dy.No.1675 mg Rs.20,000/= Dexamethasone (as Phosphate)..1mg (USP Specs.) (Corticosteroid + Antibiotic)

28. -do- 069898 Fluromax 0.1% Eye Drops 5ml Rs.48.00 07-08-2015 - Each ml contains:- Dy.No. Flurometholone ……….1mg 1664 (USP Specs.) Rs.20,000/= (Corticosteroid) 29. -do- 069951 Fluromax 0.25% Eye Drops 5ml Rs.90.00 07-08-2015 - Each ml contains:- Dy.No.1656 Fluorometholone………2.5mg Rs.20,000/= (USP Specs.) (Corticosteroid)

30. -do- 026389 Alciprox 0.3% Eye Drops 5ml Rs.90.00 07-08-2015 - Each ml contains:- Dy.No.1656 Ciprofloxacin HCl Monohydrate Rs.20,000/= 0.35% eq. to ciprofloxacin Base ………….……0.3% (USP Specs.) (Quinolone Antibiotic)

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Decision: Registration Board decided as follows:  Cancellation of registrations of above products except at S.No. 3,13,18, 24 and 26 from M/s Al-Shifa Pharmaceuticals Rawalpindi.  Registration of above products except at S.No. 3,13,18, 24 and 26 in the name of M/s M/s Alza Pharmaceuticals, Al-Shifa Trust Eye Hospital, Jhelum Road, Rawalpindi. The Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.  Products at S. No. 3, 13, 18, 24 and 26 were deferred for confirmation of approval status by the reference drug regulatory authorities.

Case No.33

Registration Board in 250th meeting approved the following drug of M/s. Shaigan Pharmaceuticals, Rawalpindi for which was previously deferred for verification of manufacturing facility for steroidal eye drops due to new policy decision about steroidal manufacturing. But later on, while drafting of registatrion letter it was found that the said formulation has not been registered in any SRA’s.In the light of said observation, the formulation may therefore be referred for renew of formulation.

1. Mionex- D Ophthalmic 1’s As Per 28-06-2010 Solution Vials SRO Fee Each ml contains:- Rs.20,000/= Moxifloxacine as HCL …. 5mg CRF OK Dexamethasone…………...1mg (Corticosteroid + Antibiotics)

Decision: Registration Board deferred the formulation for confirmation of approval status in the reference drug regulatory authorities.

Minutes for 254th Registration Board Meeting 89

Case No.34

The Registration Board in its M-241 meeting approved following products of M/s Paramount Pharmaceuticals for contract manufacturing from M/s Caraway Pharmaceuticals, Rawat for export purpose only. But the registration letter could not be issued due to the correction required for product at S. No.2 where instead of mg, gm was mistakenly written by the firm in the application dossier viz. “Each 3ml ampoule contains:- Diclofenac Sodium BP…..75gm”

Later on, the firm deposited fee of Rs.20,000 for the correction. Now, the firm has requested for issuance of letter for contract manufacturing permission for the said products.

S. Name of the Brand Name / Label Demanded Demande Date of No Firm. Claim Pack Size d Price Submission

1. Paramount Ketomount 30mg Injection 1x5’s of As Per 11-09-2013 Pharmaceuti Each 1ml ampoule 3ml SRO Dy.No.1966 cals contains:- 10x5’s of Fee Islamabad Ketorolac Tromethamine 3ml Rs.20,000 Contract USP……………30mg manufacturi (Phenyl Acetic Acid Anti- ng by M/s Rheumatic) Caraway Pharmaceuti cal Rawat

FOR EXPORT ONLY 2. -do- Diclomount 75mg Injection 1x5’s As Per 11-09-2013 Each 3ml ampoule 10x5’s SRO Dy.No.1969 contains:- Fee Diclofenac Sodium Rs.20,000 BP…..75mg (Phenyl Acetic Acid Anti- Rheumatic) 3. -do- Cefamount 1gm Injection As Per As Per 11-09-2013 Each vial contains:- SRO SRO Dy.No.1965 Ceftriaxone Sodium USP Fee eq. to Rs.20,000 Ceftriaxone………….1gm (Anti-Infectives) 4. -do- Paracef 1gm Injection As Per As Per 11-09-2013

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Each vial contains:- SRO SRO Dy.No.1967 Cefotaxime Sodium USP Fee eq. to Rs.20,000 Cefotaxime………..1gm (Anti-Infectives) 5. -do- Paracef 500mg Injection As Per As Per 11-09-2013 Each vial contains:- SRO SRO Dy.No.1968 Cefotaxime Sodium USP Fee eq. to Rs.20,000 Cefotaxime………..500mg (Anti-Infectives) 6. -do- Cefamount 500mg Injection As Per As Per 11-09-2013 Each vial contains:- SRO SRO Dy.No.1970 Ceftriaxone Sodium USP Fee eq. to Ceftriaxone Rs.20,000 ……….500mg (Anti-Infectives)

Decision: Registration Board approved the correction in composition and extended the contract manufacturing permission of above products for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.

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Registration-IV

Case No.35 Requests for Registration of Drugs for export .

The following firm have requested for registration of registration of drugs for the purpose of export only:-

1. M/s. Welmark Dopax 30 mg Tablets Copy of Export Pharmaceuticals Each film coated tablet from Knowledge Hattar contains:- House Myanamar Dapoxetine HCl Provided ≡ Dapoxetine………….30 mg (Welmark Spec)

2. -do- Dopax 60 mg Tablets -do- Each film coated tablet contains:- Dapoxetine HCl ≡ Dapoxetine………….60 mg (Welmark Spec)

3. -do- Dopax 90 mg Tablets -do- Each film coated tablet contains:- Dapoxetine HCl ≡ Dapoxetine………….90 mg (Welmark Spec)

4. -do- Resof 400mg Tablets -do- Each film coated tablet contains:- Sofosbuvir……………….. 400mg (Welmark Spec)

5. M/s. Welwrd P-Force 30 mg Tablets Copy of Export Pharmaceuticals Each film coated tablet order from Hattar contains:- BIOLIFE Dapoxetine HCl PHARMA. SRI ≡ Dapoxetine………….30 mg LANKA (Welwrd Spec) provided

6. -do- P-Force 60 mg Tablets -do- Each film coated tablet contains:- Dapoxetine HCl ≡ Dapoxetine………….60 mg (Welwrd Spec)

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7. -do- P-Force 90 mg Tablets -do- Each film coated tablet contains:- Dapoxetine HCl ≡ Dapoxetine………….90 mg (Welwrd Spec) 8. -do- Hiprex 400mg Tablets -do- Each film coated tablet contains:- Sofosbuvir……………….. 400mg (Welwrd Spec) 9. M/s. Weather Doxtin 30 mg Tablets Copy of Export Fold Each film coated tablet Order from Pharmaceuticals contains:- BIOLIFE , Hattar Dapoxetine HCl PHARMA. SRI ≡ Dapoxetine………….30 mg LANKA (Weather Folds Spec) Provided.

10. -do- Doxtin 60 mg Tablets -do- Each film coated tablet contains:- Dapoxetine HCl ≡ Dapoxetine………….60 mg ( Weather Folds Spec)

11. -do- Doxtin 90 mg Tablets -do- Each film coated tablet contains:- Dapoxetine HCl ≡ Dapoxetine………….90 mg ( Weather Folds Spec)

12. M/s. Wnsfeild Sofowin 400mg Tablets Copy of Export Pharmaceutical Each film coated tablet Order from s, Hattar contains:- THORNE FLO Sofosbuvir…………….. UK Provided 400mg . (Wnsfeild Spec)

13. M/s. Winbrain Sofobrain 400mg Tablets Copy of Export Pharmaceutical Each film coated tablet Order from s, Hattar contains:- BIOLIFE Sofosbuvir…………….. PHARMA. SRI 400mg LANKA (Winbrain Spec) Provided.

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14. M/s. Legacy Obia Tablets 400mf Copy of Export Pharmaceutical Each film coated tablet Order/request , Peshawar contains:- Provided. Sofosbuvir…………….400mg (Legacy Spec)

The firm submitted all the relevant documents along with the fee of Rs.20000/- each (with exception of Winbrain Pharmaceuticals) and requested for registration of drugs for export purpose only.

Decision: Registration Board was apprised that in 241st and 246th meeting it was decided that registration of new drugs / formulations for export purpose will be granted if applicant provide import order of any country. Registration Board deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. Accordingly, above case was decided as follows:  Approved grant of registrations for export purpose for items at S.No.1-14. Firm will deposit remaining fee for grant of registration and Chairman, Registratiuon Board will then permit isuuance of export registration letter. Manufacturer will comply following conditions before export of drug:

a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product.

Case No.36 Request for extension of contract Manufacturing Permission and change of Manufacturing site.

Registration Board in 250th meeting deferred application for extension of toll manufacturing period (where toll manufacturer was also changed) for dossiers evaluation. The following applications have been evaluated as per SOP and found in order.

S No Applicant Existing Reg No Drug Dte & Remarks Manufacturer Fee 1. M/s. Usawa M/s. Welmark 050310 Awatrox Injection 30-06- 30-06-2015 Pharmaceuticals, Pharmaceutical Each vial contains:- 2015 Firm has 146-Special s, Hattar Ceftriaxone Sodium Dy requested for

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Industrial ≡ Ceftriaxone …..250 mg No.65 change of Zone, (USP Specification) Rs.50,00 contract Risalpur 0/- manufacturer to Bio-Lab (Pvt) Ltd., Islamabad 2. -do- -do- 050311 Awatrox Injection 30-06- -do- Each vial contains:- 2015 Ceftriaxone Sodium Dy ≡ Ceftriaxone ..…500 mg No.65 (USP Specification) Rs.50,00 0/- 3. -do- -do- 050312 Awatrox Injection 30-06- -do- Each vial contains:- 2015 Ceftriaxone Sodium Dy ≡ Ceftriaxone …..….1 gm No.65 (USP Specification) Rs.50,00 0/- 4. -do- -do- 050313 Awabrod Injection 250mg 30-06- -do- Each vial contains:- 2015 Cefotaxime Sodium Dy ≡ Cefotaxime..…..250 mg No.65 (USP Specification) Rs.50,00 0/- 5. -do- -do- 050314 Awabrod Injection 500 30-06- -do- mg 2015 Each vial contains:- Dy Cefotaxime Sodium No.65 ≡ Cefotaxime …...500 mg Rs.50,00 (USP Specification) 0/-

6. -do- -do- 050315 Awabrod Injection 1gm 30-06- -do- Each vial contains:- 2015 Cefotaxime Sodium Dy ≡Cefotaxime …..1 gm No.65 (USP Specification) Rs.50,00 0/-

7. M/s. Lawari M/s. Fassgen 056682 Glifix 400 mg Capsules 30-06- 30-06-2015 International, Pharmaceutical Each capsule contains:- 2015 Firm has Saidu Sharif s, Hattar Cefixime Trihydrate Dy requested for Swat ≡ Cefixime….…400 mg No.57 change of (USP Specification) Rs.50,000/ contract - manufacturer to Bio-Lab (Pvt) Ltd., Islamabad

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i. CRF paid uptill record 2013(Lawari) ii. Renewal of DML not provided (Lawari ) Lawari Applied for CRF, certificate yet to be issued

8. -do- -do- 056683 Glifix 100 mg Suspension 30-06- -do- Each 5ml contains:- 2015 Cefixime Trihydrate Dy ≡ Cefixime………100 mg No.55 (USP Specification) Rs.50,00 0/- 9. -do- -do- 056684 Glifix 200 mg Suspension 30-06- -do- Each 5ml contains:- 2015 Cefixime Trihydrate Dy ≡Cefixime…..…200 mg No.54 (USP Specification) Rs.50,00 0/- 10. -do- -do- 056685 Spiro 250 mg Injection 30-06- -do- I.V. 2015 Each vial contains:- Dy Ceftriaxone Sodium No.51 ≡ Ceftriaxone…..250 mg Rs.50,00 (USP Specification) 0/-

11. -do- -do- 056686 Spiro 500 mg Injection 30-06- -do- I.V. 2015 Each vial contains:- Dy Ceftriaxone Sodium No.49 ≡Ceftriaxone…..500 mg Rs.50,00 (USP Specification) 0/-

12. -do- -do- 056687 Spiro 1 gm Injection I.V. 30-06- -do- Each vial contains:- 2015 Ceftriaxone Sodium Dy ≡Ceftriaxone……1 gm No.50 (USP Specification Rs.50,00 0/-

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13. -do- -do- 073207 Trize Injection 250 mg 30-06- -do- IM. 2015 Each Vial contains:- Dy Ceftriaxone Sodium No.56 ≡Ceftriaxone ..….250 mg. Rs.50,00 (USP Specification) 0/-

14. -do- -do- 073208 Trize Injection 500 mg 30-06- -do- IM. 2015 Each Vial contains:- Dy Ceftriaxone Sodium No.53 ≡Ceftriaxone ….500 mg. Rs.50,00 (USP Specification) 0/-

15. -do- -do- 073209 Trize Injection 1gm IM. 30-06- -do- Each Vial contains:- 2015 Ceftriaxone Sodium Dy ≡Ceftriaxone ….…1gm. No.52 (USP Specification) Rs.50,00 0/- 16. M/s.IPP (Pvt) M/s. Fassgen 054584 Zeus 100 mg Suspension 30-06- 30-06-2015 Ltd., Pharmaceutical Each 5ml contains:- 2015 Firm has Saidu Sharif , Hattar Cefixime ……..100 mg Dy requested for Swat (USP Specs) No.62 change of Rs.50,00 contract 0/- manufacturer to Bio-Lab (Pvt) Ltd., Islamabad IPP Applied for CRF, certificate yet to be issued

17. -do- -do- 054585 Zeus 400mg Capsules 30-06- -do- Each capsule contains:- 2015 Cefixime ………..400 mg Dy (USP Specification) No.61 Rs.50,00 0/- 18. -do- -do- 054586 Loban 250 mg Injection 30-06- -do- Each vial contains:- 2015 Ceftriaxone sodium Dy ≡ Ceftriaxone……250 mg No.58

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(USP Specification) Rs.50,00 0/- 19. -do- -do- 054587 Loban 500 mg Injection 30-06- -do- Each vial contains:- 2015 Ceftriaxone sodium Dy ≡ Ceftriaxone…..500 mg No.59 (USP Specification) Rs.50,00 0/- 20. -do- -do- 054588 Loban 1 g Injection 30-06- -do- Each vial contains:- 2015 Ceftriaxone sodium Dy ≡ Ceftriaxone.…..1 gm No.60 (USP Specifaction) Rs.50,00 0/- 21. -do- -do- 054589 Parabatom 2gm Injection 30-06- -do- Each vial contains:- 2015 Cefoperazone sodium Dy ≡ Cefoperazone….1g No.64 Sulbactam…. ……1g Rs.50,00 (IPP’s Specification) 0/-

22. -do- -do- 054590 Parabatom 1 gm Injection 30-06- -do- Each vial contains:- 2015 Cefoperazone sodium Dy ≡ Cefoperazone…500 mg No.63 Sulbactam …...500mg Rs.50,00 (IPP’s Specification) 0/- 23. M/s.Fassgen M/s. 056464 Mecobon 500mcg 30-06- 30-06-2015 Pharmaceuticals, Welmark, Injection 2015 Firm has Plot No. 67/1-A, Hattar Each 1ml contains:- Dy requested for Phase-III, Mecobalamine…...500 μg No.1042 change of Industrial Estate, (Welmark Specification) Rs.50,00 contract Hattar 0/ manufacturer to M/s. Bio- Lab (Pvt) Ltd. Islamabad Fassgen- CRF not provided 24. -do- -do- 056451 Essofass 40 mg Injection 30-06- -do- Each vial contains:- 2015 Esomeprazole Sodium Dy (powder) No.1042 ≡ Esomeprazol…..40 mg Rs.50,00 (Welmark Specification) 0/

25. -do- -do- 056465 Mepragen 40 mg Injection 30-06- -do- Each vial contains:- 2015

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Omeprazole Sodium Dy (powder) No.1042 ≡ Omeprazol…..40 mg Rs.50,00 (Welmark Specification) 0/

26. -do- -do- 056455 Pepfas 40 mg Injection 30-06- -do- Each vial contains:- 2015 Pantoprazole Sodium Dy (powder) No.1042 ≡ Pantoprazole….40 mg Rs.50,00 (Welmark Specification) 0/

27. -do- -do- 056462 Artegen 80mg Injection 30-06- -do- Each 1ml contains:- 2015 Deferred in th Artemether………80 mg Dy 245 meeting US Salmous spec No.1042 in the light of Rs.50,00 recommendati ons by Malaria 0/ Control Programme

28. M/s. Onyx M/s. Bloom 073240 Onfixime Suspension 30-06- 30-06-2015 Pharmaceuticals Pharmaceutical Each 5ml contains:- 2015 Firm has 30-A, s Hattar Cefixime trihydrate Dy requested for Industrial ≡ Cefixime...... 100 mg No.377 change of Estate, (USP Specification) Rs.50,000/ contract Mansehra - manufacturer to M/s. Bio- Lab (Pvt) Ltd., Islamabad Onyx- latest CRF not provided 29. -do- -do- 073241 Onfixime DS Suspension 30-06- -do- Each 5ml contains:- 2015 Cefixime trihydrate Dy ≡Cefixime …….200 mg No.377 (USP Specification) Rs.50,000/ - 30. -do- -do- 073242 Onfixime Capsules 30-06- -do- Each capsule contains:- 2015 Cefixime trihydrate Dy ≡ Cefixime… …..400 mg No.377 (USP Specification) Rs.50,00 0/- 31. -do- -do- 073243 Ontriax Injection 250 mg 30-06- -do- I.V 2015 Each vial contains:- Dy Ceftriaxone sodium No.377

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≡ Ceftriaxone...250 mg Rs.50,00 (USP Specification) 0/-

32. -do- -do- 073244 Ontriax Injection 500 mg 30-06- -do- I.V 2015 Each vial contains:- Dy Ceftriaxone sodium No.377 ≡Ceftriaxone…..500 mg Rs.50,00 (USP Specification) 0/-

33. -do- -do- 073245 Ontriax Injection 1g m I.V 30-06- -do- Each vial contains:- 2015 Ceftriaxone sodium Dy ≡ Ceftriaxone……...1 gm No.377 (USP Specification) Rs.50,00 0/-

Decision: Registration Board approved change in contract manufacturer (mentioned against each item) alongwith extension in contract manufacturing permission of above products for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976. In case of Ceftriaxone, where the firms have not provided route of administration (IM or IV), the Board authorized the Chairman to approve the same after getting clarification from the firm. In case the number of product applied exceed limit of 5 products per section, then extension letter will be issued after getting choice of the firm regarding products for extension and approval of the Chairman. Registration Board will be apprised accordingly in forthcoming meeting.

Case No.37 Request for registration of Drugs by M/s Wnsfeild Pharmaceuticals, Hattar

Registration Board in 238th & 246th meeting deferred the following drugs of M/s. Wnsfeild Pharmaceuticals, Hattar for confirmation of co-blister facility and product specific inspection by FDI 34. Artidoxin co-blister Tablet Form 5 Deferred for confirmation (i) 3Tablets of which Each 04-08-2010 WHO recommended coblister tablet contains Rs 20,000/- formulation / Pack Sulphadoxin USP ………500mg 2 × 10’s tab & verification of co-blister Pyrimethamine USP…..25mg As fixed by facility by area FID. (USP Spec.s) Govt. (ii) 6Tablets of which Each tablet contains Artisunate………….…50mg (Antimalarial) Finished product Specifications are (Manufacturer’s Spec.s)

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Now the Federal Inspector of Drugs inspected the unit on 02-04-2015 and confirm that the firm has provided the facilities of above mentioned product for co-blistering and recommended for registration.

Decision: Registration Board approved the grant of registration of above product (Artidoxin co-blister Tablet).

Case No.38 Request for correction in formulation of registered drug by M/s. Wnsfeild Pharmaceuticals, Hattar.

Registration Board in 237th meeting approved the following drug of M/s. Wnsfeild Pharmaceuticals, Hattar as per detail given below:-

S.No Reg No Applied formulation Granted formulation

1 075593 Wintro 50 mg Injection Wintro 50 mg Injection Each 2 ml ampoule contains:- Each 2 ml ampoule contains:- Tramadol HCl……50 mg/ml Tramadol HCl……50 mg (Wnsfeild Specification) (Wnsfeild Specification)

Now the management of the firm has requested for correction in formulation as under in accordance with that of brand leader. The firm has already deposited Rs.20,000/- for correction in formulation.

1 075593 Wintro 50 mg Injection 2mlx5’s Each 2 ml ampoule contains:- Tramadol HCl……100 mg (Wnsfeild Specification)

Decision: Registration Board approved in correction in formulation with change of name to Wintro 100mg Injection.

Case No.39 Request for Registration of Drugs

M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration letter of Zoramid (Domperidone) Suspension which was approved in 243rd meeting ofRegistration Board with the following formulation:-

Zoramid Suspension Each 5ml contains:-

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Domperidone Maleate eq. to Domperidone….5mg

The registration letter was not issued due to inappropriate active pharmaceutical ingredient and the ambiguous label claim. As per composition of Motilium Suspension (brand leader Johnson & Johnson) and BNF 66, the Suspension contains Domperidone 5mg/5ml instead of Domperidone maleate equivalent to Domperidone 5mg/5ml. The management subsequently claimed to have corrected the formulation and label claim of Zormid Suspension and submitted the same to the PEC before the commencement of DRB 243rd meeting-. However the aforementioned change could not be reflected in the agenda of 243rd Drugs Registration Board meeting inadvertently. The Evaluation Cell later confirmed from the record that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected the composition as per reference product but the same could not be reproduced into the agenda and minutes of 243rd meeting of DRB. The case was subsequently deferred by the Registration Board in 246th meeting for referral to Review Committee in conformity of decision of 244th meeting. Subsequently the Board in 250th meeting approved the following formulation:-

DOMPERIDONE 5MG/5ML LIQUID SUSPENSION

Decision: Registration Board approved the correct composition as Domperidone 5mg/5ml Liquid Suspension.

Case No. 40 Request for extension in Contract Manufacturing Permission.

M/s. Lawari International, Swat has requested for extension in contract manufacturing of the following products.

1 M/s. Lawari M/s. English 069703 EsoMine 40mg Injection 29-06- International, Pharma, Each vial contains:- 2015 Swat Lahore Esopmeprazole Dy No.315 Lyophilized Rs.50,000/ Powder……….40mg - (Manufacturer Specification)

2 -do- -dp= 069704 Omepmine 40mg 29-06- Injection 2015 Each vial contains:- Dy No.315 Sterile Omeprazole Rs.50,000/ sodium lyophilized - ≡ Omeprazole…40mg

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(PPIS)

3 -do- -do- 069705 CiproMine 200mg 29-06- Infusion 2015 Each vial contains:- Dy No.315 Ciprofloxacin HCl Rs.50,000/ equivalent to - Ciprofloxacin………200 mg (USP Specification)

4 -do- -do- 069800 LevoMine Infusion 29-06- Required 500mg 2015 confirmatio Each 100ml contains:- Dy No.315 n of Levofloxacin (as Rs.50,000/ previous Hemihydrate)….500mg - extension in (Manufacturer 2013. Specification)

5 -do- -do- 069706 MeMine 500mcg 29-06- -do- Injection. 2015 Each ml contains:- Dy No.315 Mecobalamin…..500mcg. Rs.50,000/ (Lawari Specification) -s

The firm deposited the fee of Rs. 50,000/- each for extension of above mentioned drugs. The products at S.No.1- 3 are deferred in 238th meeting due to policy not finalized. Decision: Registration Board approved extension in contract manufacturing permission of above products for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976. In case the number of product applied exceed limit of 5 products per section, then extension letter will be issued after getting choice of the firm regarding products for extension and approval of the Chairman. Registration Board will be apprised accordingly in forthcoming meeting.

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Registration-V Case No. 41:

Registration Board in its 238th meeting deferred the following products of M/s. Prime Laboratories Lahore till the decision on show / case notice/stop production to the firm dated 23rd April, 2013:- S. No. Name of Drug(s) with Pack Demanded Date of Decision of the formulation size price applicatio Registration Board. n 1. Dicloprime SR Capsules 2x10’s As per 26-05-10 Deferred till Each prolonged release capsule SRO decision on show contains:- cause notice/stop Diclofenac Sodium SR pellets production to the equiv. to firm dated 23rd Diclofenac Sodium …100mg April, 2013. Source of pellets and composition is not mentioned but deposited Rs. 100000/-

2. Primcevit 100mg Tablets 1x1000’ Rs220.00 -do- Deferred till Each tablet contains:- s decision on show Ascorbic Acid…..100mg cause notice/stop (vitamin) production to the B.P. Specifications firm dated 23rd April, 2013. 3. Sodamint Tablets 1x1000’ Rs.48.50 -do- Deferred till Each tablet contains:- s decision on show Sodium Bicarbonate…..300mg cause notice/stop (antacid/ Deflatulent) production to the BP Specifications firm dated 23rd April, 2013. 4. Aspirin Tablets 3x10’s Rs.26.00 -do- Deferred till Each Enteric coated decision on show tablet contains:- cause notice/stop Aspirin….75mg production to the BP Specifications firm dated 23rd April, 2013. 5. Primazole Tablets 20x10’s Rs.180.00 -do- Deferred till Each film coatedtablet contains:- 1x200’s Rs.165.00 decision on show Metronidazole…..200mg cause notice/stop BP Specifications production to the firm dated 23rd April, 2013. 6. Primadyl Tablets 10x10’s Rs.40.00 -do- Deferred till 1x1000’ Rs.350.00 decision on show

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Each Enteric coated tablet s cause notice/stop contains:- production to the Bisacodyl….5mg firm dated 23rd BP Specifications April, 2013. 7. Famoprime Tablets 1x10’s Rs.150.00 -do- Deferred till 2x10’s Rs.290.00 decision on show Each film coated tablet contains:- cause notice/stop Famotidine…..40mg production to the USP Specifications firm dated 23rd April, 2013. 8. Kaolin Poultice 80g Jar Rs.25.00 -do- Deferred till Each 100gm contains:- 100g Jar Rs.31.50 decision on show Boric Acid….4.5gm 300g Jar Rs.80.00 cause notice/stop (antiseptic) 400g Jar Rs.110.50 production to the BPC Specifications firm dated 23rd April, 2013. 9. Ferrous Sulphate Tablets 1x1000’ Rs.180.00 -do- Deferred till Each sugar coated ablet contains:- s decision on show Ferrous sulphate…..200mg cause notice/stop (anti-anemic preparation malarial) production to the BP Specifications firm dated 23rd April, 2013.

The Show Cause was resolved and the firm was permitted to start manufacturing activities at their premises. They have requested to grant them registration of above products. Decision: Registration Board decided as follows:  Approved registration for products at S.No.4-9.  Deferred product at S.no.1 for confirmation of source of pellets and requisite fee and products at S.No. 2 and 3 for clarification of formulation as it exist in chewable tablets and firm applied as plain tablets.

Case No.42. Application for Export of Drugs other than me-too.

i. Registration of Sofosbuvir Tablets.

Following firms have requested for registration of following products for export purpose only:-

S. No Name of the Name of Products Documents submitted firm(s) 1. M/s. Highnoon Sovax Tablet 400mg a. Fee of Rs. 20000/- for this Laboratories, Each film coated tablet contains:- purpose. Lahore Sofosbuvir ……….. 400mg b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF.

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e. Approval of section by CLB.

2. M/s. Shrooq Valdi Tablet a. Fee of Rs. 20000/- for this Pharmaceuticals Each film coated tablet contains:- purpose. Lahore Sofosbuvir ……….. 400mg b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.

3. M/s. Novamed Valdi Tablet a. Fee of Rs. 20000/- for this Pharmaceuticals, Each film coated tablet contains:- purpose. Lahore Sofosbuvir ………….. 400mg b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.

The applications are not yet evaluated as recently.

Decision: Registration Board approved grant of registrations for export purpose for items at S.No.1-3. Manufacturer will comply following conditions before export of drug: a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product.

ii. Correction in formulation of Non-Me-too Drugs

The Registration Board in its 250th meeting deferred the following product of M/s. Elite Pharma (Pvt.) Ltd; Lahore which was applied for export purpose only:-

S. No Name of Products 1. Capronic 100ml Infusion Each ml contains: Aminocaproic Acid……..50mg/ml

The firm has submitted the following documents:-

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a. Fee of Rs.20000/- for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.

Product at Sr. No. 1 Aminocaproic Acid Infusion 250/ml (USP specs) has to be prepared according to international availability.The management of the firm has rectified the formulation accordingly which is as under:-

S. No Name of Products 1. Capronic 100ml Infusion Each ml contains: Aminocaproic acid…….. 250mg/ml USP specs

Decision: Registration Board approved grant of registrations of above product for export purpose only. Firm will deposit remaining fee for grant of registration and Chairman, Registratiuon Board will then permit isuuance of export registration letter. Manufacturer will comply following conditions before export of drug:

a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product. iii. M/s. English Pharmaceutical Industries, Lahore. M/s. English Pharmaceutical Industries, Lahore has requested for registration of following products for export purpose only:- S. No Name of Product 1. Calci Suspension Each 5ml contains: Calcium Carbonate (BP)……. 625mg eq. to Elemental Calcium ……….250mg Cholecalciferol ……125 IU 2. Exo 180mg Tablet Each film coated tablet Contains: Fexofenadine Hydrochloride eq. to

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Fexofenadine ………180mg 3. Engcef Suspension Each 5ml contains: Cefixime Trihydrate eq. to Cefixime ………..100mg 4. Engcef 200mg Capsule Each capsule contains: Cefixime Trihydrate eq. to Cefixime ……200mg May be capsule 5. Axym Suspension Each 5ml contains: Cefixime Trihydrate eq. to Cefixime 100mg 6. Esvordi Tablet Each film coated tablet Contains: Sofosbuvir………400mg 7. Ezone 1Gm I.V/I.M Injection Each vial contains: Ceftrixione Sodium 1000mg

8. Enofer Syrup Each 5ml contains: Iron (III) Hydroxide Polymaltose Complex Equilent to elemental Iron……50mg Folic Acid………0.35mg 9. Enofer Tablet Each tablet contains: Iron (III) Hydroxide Polymaltose Complex equivalent to elemental Iron ……100mg Folic Acid….0.35mg 10. Axym 200mg tablet Each film coated tablet Contains: Cefixime Trihydrate eq. to Cefixime 200mg 11. Exo 120mg Tablet Each film coated tablet Fexofeadine Hydrochloride eq. to Fexofendine …….120mg 12. Pantakure 20mg Tablet Each Enteric Coated tablet Contains Pantoprazole (as Sodium Sesquhydrate…200mg 13. Fercalite Injection Each 2ml Contains: Iron Dextran eq. to elemental iron …..100mg 14. Ambroxal 30mg/5ml Each 5ml Contains Ambroxal Hydrochloride eq. to Ambroxol….. 30mg

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15. Ambroxal 15mg/5ml Each 5ml contains: Ambroxol Hydrochloride eq. top Ambroxol ….15mg

The case was placed before the Registration Board in its 248th meeting and discussed the panel inspection report & reference sent by Central Licensing Board and decided as under; a. No new registration (including export) will be granted to the firm till the extension of facility. b. Show cause notice will be issued to the firm for the suspension of registration of lyophilized products till the clarification from the firm about the procedural validations, verifying filling of lyophilized material maintain its effectiveness and physical parameters under the condition of filling as practiced by the firm. Reply submitted by the firm will be presented before Registration Board for consideration. c. Firm will advised to provide detail of all registered products with their renewal status for rational reduction as recommended by inspecting panel. Moreover, the matter regarding renewal of all sections except Capsule (General) and Tablet-I (General) will be discussed in forthcoming meeting with aforementioned data. d. The Board deferred the case for discussion on segregated facilities for carbepenems (meropenem), Psychotropics (clonazepam) and steroidal injection (dexamethasone as sodium phosphate) till next meeting of the Board.

M/s. English Pharmaceuticals, Lahore was served a show cause notice for suspension of registration of lyophilized products as the panel recommended to suspend the registration of lyophilized products till the clarification from the firm about the procedural validations, verifying filling of lyophilized material maintain its effectiveness and physical parameters under the condition of filling as practiced by the firm. The firm was asked to submit their reply within fortnight which had to be placed before Registration Board for further processing the case. M/s. English Pharmaceuticals, Lahore has submitted that they have extended their quality control laboratory 5 times more than previous laboratory. They have requested to allow their registration for export purpose to earn foreign currency exchange. In the meanwhile the firm has provided copy of panel inspection which was conducted by panel comprising Mr. Ajmal Sohail, FID, Mr. Asim Rauf, FID, Mr. Nadeem Iqbal Ex-Member, CLB, Dr. Zaka-ur-Rehman, Chief Drugs Controller, Punjab and Mr. Jamil Anwar, Director, DTL, Lahore and again requested to grant them new registrations. The case was referred to Licensing Division for their comments. The Licensing Division has informed that firm’s report was presented in 234th meeting of CLB dated 09-09-2015 for verification of observations as under:-

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“It was observed that firm has been granted approximately 400 registrations. It is recommended that no new registration of drugs be given to firm till rectification/extension of facility in addition to already given registration is reduce rationally”. Accordingly inspection report dated 10-08-2015 was received and presented to CLB in 234th meeting dated 09-09-2015 in which panel recommended for consideration for grant of new registration for local/export purpose in light of expansion. Central Licensing Board considered the case; however the minutes of meeting are awaited for implementation after approval.

Decision: Registration Board noted the information.

Case No.43. CANCELLATION OF REGISTRATION FROM PREVIOUS NAME OF THE FIRM AND REGISTRATION IN THE NEW NAME OF THE FIRM.

i. M/s. Allmed (Pvt.) Ltd; Lahore M/s. Allmed (Pvt.) Ltd; Lahore has requested to register in their following products in their new name of the firm i.e M/s. Allmed (Pvt.) Ltd; Lahore instead of M/s. Evergreen Pharmaceuticals (Pvt.) Ltd; Lahore at same site. They have provided approval of change of title from Licensing Section:- S. No Reg. No. Name of drug (s) & Composition 1. 067757 Pamiz Tablet Each tablet contains:- Diazepam…5mg (B.P Specs) 2. 067758 Alzo-A Tablet Each tablet contains:- Alprazolam…..0.25mg (USP Specs) 3. 067759 Alzo-ATablet Each tablet contains:- Alprazolam…..0.5mg (USP Specs) 4. 067760 Alzo-A Tablet Each tablet contains:- Alprazolam…..1mg (USP Specs) 5. 067761 Penzee Tablet Each tablet contains:- Bromazepam….3mg (Evergreen’s Specs)

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6. 067762 Penzee Tablet Each tablet contains:- Bromazepam….6mg (Evergreen’s Specs)

The management of the firm has deposited fee of Rs. 20,000/- for each products. The above registrations are valid until 27-10-2015. The firm has separate tablet (Psychotropic) section as per panel inspection report. Decision: Registration Board approved registration of above six products in name of M/s Allmed (Pvt.) Ltd; Lahore as per guidelines approved in 246th meeting.

ii. M/s. Soma Laboratories, Lahore.

M/s. Soma Laboratories, Lahore has requested to cancel the registration from previous address 692/N Smanabad, Lahore and register in new address Lahore to 43-D, Sundar Industrial Estate of the firm:- S. No Reg. No. Name of drug (s) & Composition 1. 007053 Sodamint Tablet Each tablet contains:- Sodium Bicarbonate ... 300mg Pepper mint oil ……... 0.003ml BP Specifications 2. 015825 Gastadine Tablet Each film coated tablet contains:- Famotidine …. 40mg USP Specifications 3. 006581 Chlorpheniramine Tablet Each tablet contains:- Chlorpheniramine …………….. 4mg USP Specifications 4. 006593 Paracetamol Tablet Each tablet contains:- Paracetamol …………………. 500mg BP Specifications 5. 006170 Septinol Tablet Each tablet contains:- Sulphamethoxazole ………. 400mg Trimethorprim ……………. 80mg BP Specifications

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6. 006787 Vitamin B Compound Contains:- Vitamin B1 ………. 1.0mg Vitamin B2 ………. 1mg Nicotinamide …….. 15mg

7. 006160 Rehydrate Salt Each sachet contains:- Sodium chloride …………… 2.6gm Trisodium Citrate Dehydrate …. 1.5 gm Potassium Chloride ………….. 1.5gm Glucose Anhydrous ……. 13.5mg (B.P Specification) 8. 006785 Parafed-P Tablet Each tablet contains:- Paracetamol ……………. 300mg Pseudoephedrine HCl …. 36mg TriprolidineHCl …………….. 1.5mg Manufacturer’s Specification 9. 015826 Carpaz Tablet Each tablet contains:- Carbamazepin ……………. 200mg (B.P Specification)

The firm has submitted application dossier along with fee of Rs. 20,000/- .

Decision: Rgistration Board approved the request of the firm for the product of S.No. 2,3,4,5,6,7,8 and 9 and defer the product mentioned above at S.No 1 for clarification of formulation (chewable or plain).

Case No.46 Extension of Contract Manufacturing

Registration Board in its 238th meeting deferred the following products of M/s. Tagma Pharma (Pvt.) Ltd; Lahore through contract manufacturing by M/s. Frineds Pharma (Pvt.) Ltd; Lahore as did not cover under the contract manufacturing policy at that time:- S. Reg. no. Name of Drug(s) Date of application and fee No. 1. 032314 Cepsi 200mg Injection 03-05-2013 Rs.50000/- 8-03-2004 Each ml contains: Form-5 Ciprofloxacin ….. 2mg 2. 032315 Pelikan Infusion 03-05-2013 Rs.50000/- Form-5 8-03-2004 Each ml contains: Levofloxacin ….. 5mg

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Now the firm has requested that these are cover under current contract policy. The firm had submitted above application for extension till 30-06-2015 at that time. However, the permission was not granted rather deferred the same. Decision: Request of the firm was acceded by the Board with the submission of prescribed fee (Rs.50000/-) and Chairman Registration Board is authorized to approve the case. It is in line with Rule 20A of Drugs (L, R & A) Rules, 1976. Condition will be mentioned in registration letter that firm will purchase and perform installation and operational qualifications of TOC analyser and liquid particle counter in six months time.

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Grant of Registration – Pharmaceutical Evaluation & Registration Division:

Case No.01: Grant of registrations to New Molecules.

a. Locally manufactured.

Incharge PEC

S/N Name and Brand Name Type of Form Remarks on Remarks by address of (Proprietary name + Dosage the Evaluator manufacturer Form + Strength) Initial date, formulation / Applicant diary (if any) Composition including Fee including International Pharmacological Group differential fee status in stringent Finished product Demanded drug Specification Price / Pack regulatory size agencies / authorities

Me-too status

GMP status as depicted in latest inspection report (with date) by the Evaluator 1. M/s Hilton Esli 800mg Tablets Form-5-D Aptiom The Board Pharma (Pvt.) Each Tablet contains: 800mg by considered the Ltd. 13, Sector Eslicarbazepine Dy. No: 1639 Sunovion application and 15, Korangi Acetate….800mg dated 27-08- Pharms INC deferred for Industrial (Anti-epileptic) 2013 (FDA) submission of Area, Karachi. scientifically 50,000/- dated rational lab 27-08-2013 scale data as Rs.825/Tab per guidelines approved in 251st meeting.

2. M/s Hilton Esli 400mg Tablets Form-5-D Aptiom The Board Pharma (Pvt.) Each Tablet contains: 400mg by considered the Ltd. 13, Sector Eslicarbazepine Dy. No: 1637 Sunovion application and 15, Korangi Acetate….400mg dated 27-08- Pharms INC deferred for Industrial 2013 (FDA) submission of Area, Karachi. (Anti-epileptic) scientifically 50,000/- dated rational lab 27-08-2013 scale data as

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10’s,20’s,30’s per guidelines Rs.6,000/- approved in Rs.12,000/- 251st meeting. Rs.18,000/- 3. M/s Hilton Esli 200mg Tablets Form-5-D Aptiom The Board Pharma (Pvt.) Each Tablet contains: 200mg by considered the Ltd. 13, Sector Eslicarbazepine Dy. No: 1638 Sunovion application and 15, Korangi Acetate….200mg dated 27-08- Pharms INC deferred for Industrial 2013 (FDA) submission of Area, Karachi. (Anti-epileptic) scientifically 50,000/- dated rational lab 27-08-2013 scale data as 10’s,20’s,30’s per guidelines Rs.4,000/- approved in Rs.8,000/- 251st meeting. Rs.12,000/- 4. M/s Hilton Rasidon 120mg Form-5-D Latuda The Board Pharma (Pvt.) Each Tablet contains: Sunovion considered the Ltd. 13, Sector Lurasidone Dy. No: 139 Pharm INC application and 15, Korangi HCl………..…120mg dated 13-02- deferred for Industrial (Antipsychotic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 13-02-2013 rational lab 10’s,20’s30’s scale data as Rs.16,000/- per guidelines Rs.32,000/- approved in Rs.48,000/- 251st meeting. 5. M/s Hilton Rasidon 80mg Form-5-D Latuda The Board Pharma (Pvt.) Each Tablet contains: Sunovion considered the Ltd. 13, Sector Lurasidone Dy. No: 141 Pharm INC application and 15, Korangi HCl………..…80mg dated 13-02- deferred for Industrial (Antipsychotic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 13-02-2013 rational lab 10’s,20’s30’s scale data as Rs.15,000/- per guidelines Rs.30,000/- approved in Rs.45,000/- 251st meeting. 6. M/s Hilton Rasidon 40mg Form-5-D Latuda Stability Pharma (Pvt.) Each Tablet contains: Sunovion Studies Ltd. 13, Sector Lurasidone Dy. No: 180 Pharm INC conducted 15, Korangi HCl………..…40mg dated 13-02- under the Zone Industrial (Antipsychotic) 2013 IV-A Area, Karachi. 50,000/- dated conditions as 13-02-2013 per ICH / 10’s,20’s30’s WHO Rs.14,000/- guidelines. Rs.28,000/- Rs.42,000/-

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7. M/s Hilton Rasidon 20mg Form-5-D Latuda The Board Pharma (Pvt.) Each Tablet contains: Sunovion considered the Ltd. 13, Sector Lurasidone Dy. No: 183 Pharm INC application and 15, Korangi HCl………..…20mg dated 13-02- deferred for Industrial (Antipsychotic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 13-02-2013 rational lab 10’s,20’s30’s scale data as Rs.13,000/- per guidelines Rs.26,000/- approved in Rs.39,000/- 251st meeting. 8. M/s Hilton Canaglu 100mg Tablets Form-5-D Invokana The Board Pharma (Pvt.) Each film coated Tablet FDA considered the Ltd. 13, Sector contains: Dy. No: 1585 application and 15, Korangi Canagliflozin……100mg dated 23-08- deferred for Industrial (Anti-Diabetic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 23-08-2013 rational lab 10’s/Rs.6,500/- scale data as per guidelines approved in 251st meeting. 9. M/s Hilton Canaglu 300mg Tablets Form-5-D Invokana The Board Pharma (Pvt.) Each film coated Tablet FDA considered the Ltd. 13, Sector contains: Dy. No: 1582 application and 15, Korangi Canagliflozin……300mg dated 23-08- deferred for Industrial (Anti-Diabetic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 23-08-2013 rational lab 10’s/Rs.7,500/- scale data as per guidelines approved in 251st meeting. 10. M/s Hilton Dapa 10mg Tablets Form-5-D Farxiga The Board Pharma (Pvt.) Each film coated Tablet (Astrazeneca considered the Ltd. 13, Sector contains: Dy. No: 1584 ab) 50mg, application and 15, Korangi Dapagliflozin………10mg dated 23-08- 10mg FDA deferred for Industrial (Anti-Diabetic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 23-08-2013 rational lab 10’s/Rs.7,000/- scale data as per guidelines approved in 251st meeting. 11. M/s Hilton Dapa 5mg Tablets Form-5-D Farxiga The Board Pharma (Pvt.) Each film coated Tablet (Astrazeneca considered the Ltd. 13, Sector contains: Dy. No: 1583 ab) 50mg, application and 15, Korangi Dapagliflozin………5mg dated 23-08- 10mg FDA deferred for Industrial (Anti-Diabetic) 2013 submission of Area, Karachi. 50,000/- dated scientifically 23-08-2013 rational lab

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10’s/Rs.5,500/- scale data as per guidelines approved in 251st meeting. 12. M/s Hilton Apix 2.5mg Tablets Form-5-D Eliquis The Board Pharma (Pvt.) Tablet. 2.5mg, 5mg considered the Ltd. 13, Sector Each film coated Tablet Dy. No: 400 (BMS) FDA application and 15, Korangi contains: dated 06-11- deferred for Industrial Apixaban…….2.5mg 2013 submission of Area, Karachi. (Anticoagulant) 50,000/- dated scientifically 06-11-2013 rational lab 10’s,20’s,60’s scale data as Rs.475/tablet- per guidelines approved in 251st meeting. 13. M/s Hilton Apix 5mg Tablets Form-5-D Eliquis The Board Pharma (Pvt.) Tablet. 2.5mg, 5mg considered the Ltd. 13, Sector Each film coated Tablet Dy. No: 102 (BMS) FDA application and 15, Korangi contains: dated 07-02- deferred for Industrial Apixaban…….5mg 2014 submission of Area, Karachi. (Anticoagulant) 50,000/- dated scientifically 07-02-2014 rational lab 10’s,20’s,60’s scale data as Rs.516.58/tablet- per guidelines approved in 251st meeting. 14. M/s Getz Lansodex Capsule 60mg Form-5-D Dexlanxilant The Board Pharma, Delayed Release Capsules Dy No.269 30mg, 60mg considered the (Private) Each delayed release contains: dated 19-10- Takeda application and Limited 29- Enteric coated pellets of 2011 Pharms FDA. deferred for 30/27, Korangi Dexlansoprazole…….60mg Rs.15,000/- submission of Industrial Area PPI (Proton Pump Inhibitor) dated 30-07- scientifically Karachi. 2013 rational lab Rs. 5,000/- scale data as 06-08-2015 per guidelines Rs.30,000/- approved in 14’s/Rs.1680/- 251st meeting. 15. M/s Getz Lansodex Capsule 30mg Form-5-D Dexlanxilant The Board Pharma, Delayed Release Capsules Dy No.268 30mg, 60mg considered the (Private) Each delayed release contains: dated Takeda application and Limited 29- Enteric coated pellets of 19-10-2011 Pharms FDA. deferred for 30/27, Korangi Dexlansoprazole…….30mg Rs.15,000/- submission of Industrial Area PPI (Proton Pump Inhibitor) dated 30-07- scientifically Karachi. 2013 rational lab Rs. 5,000/- scale data as 06-08-2015 per guidelines Rs.30,000/- approved in 14’s/Rs.840/- 251st meeting.

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16. M/s Getz Previr Form-5-D Inspection. The Board Pharma, Film coated tablet. Dy No.117 15-12-2010 considered the (Private) Each film coated tablet dated 31-08-- International application and Limited 29- contains: 2013 status not deferred for 30/27, Korangi Telaprevir……750 15,000/- confirmed submission of Industrial Area Anti viral (HCV serine Rs.35,000/- scientifically Karachi. protease inhibitors) dated 30-08- rational lab 2013 scale data as 10’s,30’s per guidelines Rs.10,000/- approved in Rs.30,000/- 251st meeting. 17. M/s Getz Previr Form-5-D Incivek by The Board Pharma, Film coated tablet. Dy No.116 Vertex considered the (Private) Each film coated tablet dated 31-08- pharms application and Limited 29- contains: 2013 FDA:375mg deferred for 30/27, Korangi Telaprevir……375 15,000/- Inspection. submission of Industrial Area Anti viral (HCV serine Rs.35,000/- 15-12-2010 scientifically Karachi. protease inhibitors) dated 30-07- rational lab (Getz specs) 2013 scale data as 10’s,30’s per guidelines Rs.5,000/- approved in Rs.15,000/- 251st meeting. 18. M/s Amgydex ST Form-5D The Board Remington Ophthalmic Suspension Rs.15,000/- considered the Pharmaceutical Each ml contains:- Dated. 30-06- application and Industries Tobramycin 2012. deferred for (Pvt.) Ltd. U.S.P………3.0mg 35,000/- dated submission of 18km Multan Dexamethasone 30-07-2013 scientifically Road, Lahore U.S.P…..0.5mg 5ml, 10ml,15ml rational lab (Antibiotic & Corticosteroid) Rs.300/- scale data as per guidelines approved in 251st meeting. 19. M/s Moxear-D Form-5D Deferred for Remington Ear Drops Dy. No: 3420 confirmation Pharmaceutical Each ml contains:- Rs.15,000/- of approval Industries Moxifloxacin Hydrochloride Dated. 02-05- status by (Pvt.) Ltd. B.P equivalent to 2012. reference 18km Multan Moxifloxacin..5.0mg 35,000/- dated regulatory Road, Lahore Dexamethasone Sodium 30-07-2013 authorities Phosphate U.S.P eq to 5ml, 10ml,15ml Dexamethasone Rs.300/- Phosphate….1.0mg (Antibiotic & Corticosteroid) 20. M/s Dorolol Form-5D Deferred for Remington Eye Drops Dy. No: 3420 confirmation Pharmaceutical Each ml contains:- Rs.15,000/- of approval Industries Dorzolamide Hydrochloride Dated. 02-05- status by (Pvt.) Ltd. U.S.P eq to 2012. reference 18km Multan Dorzolamide…………20mg 35,000/- dated regulatory Road, Lahore Timolol Maleate U.S.P. eq. to 30-07-2013 authorities

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Timolol…………………..5mg 5ml, 10ml,15ml Brimonidine Tartrate……2mg Rs.1100/- (Carbonic Anhydrase Inhibitor)

b.Finished Import. Incharge PEC S/N Name and Brand Name Type of Remarks on Decision address of (Proprietary name + Form the manufacturer / Dosage Form + Strength) formulation Applicant Initial date, (if any) Composition diary including International Pharmacological Group Fee status in including stringent Finished product differential drug Specification fee regulatory agencies / Demanded authorities Price / Pack size Me-too status

GMP status as depicted in latest inspection report (with date) by the Evaluator 21. M/s Novartis Ultibro Breezhaler Form-5 (A) Ultibro Approved subject Pharma Each Capsule contains: Breezhaler to compliance of (Pakistan) Indacaterol 110mcg and Dy. No: 84 Novartis Import Policy for Limited, 15 West Glycopyrronium 50mcg dated 22-01- Europharm Finished Drugs Wharf P.O Box (143 microgram 2014 Limited. and confirmation 100 Karachi. glycopyrrnium bromide EMA of storage facility Novartis Pharma equivalent to 110 100,000/- of importer. Stein AG, Stien, micrograms glycopyrrnium) dated 22-01- Switzerland. 2014 (Bronchodilator) 30’s Rs.6,424/- 22. M/s AGP Neupro ® 2mg/24hr Form-5 (A) Neupro UCB Approved subject (Private) Each patch of 10cm2 INC to compliance of Limited. B-23 contains 4.5mg Rotigotine Dy. No: 386 Import Policy for S.I.T.E Karachi. (UCB Specs) dated 19-05- Finished Drugs (Antiepileptic) 2014 and confirmation LTS Lohmann of storage facility Therapie-System 100,000/- of importer. AG, Lohmannstr dated 19-05- 2,D-56626 2014

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Andernach, 28’s Germany Rs.7,115/-

23. M/s AGP Neupro ® 4mg/24hr Form-5 (A) Neupro UCB Approved subject (Private) Each patch of 20cm2 INC to compliance of Limited. B-23 contains 9.0mg Rotigotine Dy. No: 387 Import Policy for S.I.T.E Karachi. (UCB Specs) dated 19-05- Finished Drugs (Antiepileptic) 2014 and confirmation LTS Lohmann of storage facility Therapie-System 100,000/- of importer. AG, Lohmannstr dated 19-05- 2,D-56626 2014 Andernach, 28’s Germany Rs.14,225/- 24. M/s AGP Neupro ® 6mg/24hr Form-5 (A) Neupro UCB Approved subject (Private) Each patch of 30cm2 INC to compliance of Limited. B-23 contains 13.5mg Rotigotine Dy. No: 384 Import Policy for S.I.T.E Karachi. (UCB Specs) dated 19-05- Finished Drugs (Antiepileptic) 2014 and confirmation LTS Lohmann of storage facility Therapie-System 100,000/- of importer. AG, Lohmannstr dated 19-05- 2,D-56626 2014 Andernach, 28’s Germany Rs.21,340/- 25. M/s AGP Neupro ® 8mg/24hr Form-5 (A) Neupro UCB Approved subject (Private) Each patch of 40cm2 INC to compliance of Limited. B-23 contains 18.0mg Rotigotine Dy. No: 380 Import Policy for S.I.T.E Karachi. (UCB Specs) dated 19-05- Finished Drugs (Antiepileptic) 2014 and confirmation LTS Lohmann of storage facility Therapie-System 100,000/- of importer. AG, Lohmannstr dated 19-05- 2,D-56626 2014 Andernach, 28’s Germany Rs.28,450/- 26. M/s AGP Vimpat film coated tablet Form-5 (A) Vimpat UCB The applied (Private) 150mg INC FDA molecule is me- Limited. B-23 Tablet Dy. No: 131 50mg, too in Pakistan S.I.T.E Karachi. Each film coated tablet dated 20-09- 100mg, the board contains: 2013 150mg, approved the M/s Aesica Lacosamide….150mg (UCB 200mg product for Pharmaceutical specs) 100,000/- GmbH (Antiepileptic) dated 20-09- registration Galileistrasse 6 2013 being research 08056 56’s product / Zwickau Rs.40,230/- innovator brand, Germany. subject to compliance of Import Policy for

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Finished Drugs and confirmation of storage facility of importer . 27. M/s AGP Vimpat film coated tablet Form-5 (A) Vimpat UCB The applied (Private) 50mg INC FDA molecule is me- Limited. B-23 Tablet Dy. No: 133 50mg, too in Pakistan S.I.T.E Karachi. Each film coated tablet dated 20-09- 100mg, the board contains: 2013 150mg, approved the M/s Aesica Lacosamide….50mg (UCB 200mg product for Pharmaceutical specs) 100,000/- GmbH (Antiepileptic) dated 20-09- registration Galileistrasse 6 2013 being research 08056 14’s product / Zwickau Rs.3,352/- innovator brand, Germany. subject to compliance of Import Policy for Finished Drugs and confirmation of storage facility of importer . 28. M/s AGP Vimpat film coated tablet Form-5 (A) Vimpat UCB The applied (Private) 100mg INC FDA molecule is me- Limited. B-23 Tablet Dy. No: 128 50mg, too in Pakistan S.I.T.E Karachi. Each film coated tablet dated 20-09- 100mg, the board contains: 2013 150mg, approved the M/s Aesica Lacosamide….100mg (UCB 100,000/- 200mg product for Pharmaceutical specs) dated 20-09- GmbH (Antiepileptic) 2013 registration Galileistrasse 6 56’s being research 08056 Rs.26,820/- product / Zwickau innovator brand, Germany. subject to compliance of Import Policy for Finished Drugs and confirmation of storage facility of importer. 29. M/s AGP Vimpat film coated tablet Form-5 (A) Vimpat UCB The applied (Private) 200mg INC FDA molecule is me- Limited. B-23 Tablet Dy. No: 132 50mg, too in Pakistan S.I.T.E Karachi. Each film coated tablet dated 20-09- 100mg, the board contains: 2013 150mg, approved the M/s Aesica Lacosamide….200mg (UCB 100,000/- 200mg product for Pharmaceutical specs) dated 20-09- GmbH (Antiepileptic) 2013 registration Galileistrasse 6 56’s being research 08056 Rs.53,640/- product / Zwickau innovator brand,

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Germany. subject to compliance of Import Policy for Finished Drugs and confirmation of storage facility of importer . 30. M/s AGP Vimpat Syrup 10mg/ml Form-5 (A) Vimpat UCB Approved subject (Private) Syrup INC 10mg/ml to compliance of Limited. B-23 Each ml contains: Dy. No: 129 oral solution Import Policy for S.I.T.E Karachi. Lacosamide….10mg (UCB dated 20-09- Finished Drugs specs) 2013 and confirmation M/s UCB (Antiepileptic) 100,000/- of storage facility Manufacturing dated 20-09- of importer. Inc. 331 Clay 2013 Road (755 200ml Jefferson Road) Rs.14,268/- Rochester, NY 14623 USA 31. M/s AGP Vimpat 10mg/ml solution Form-5 (A) Vimpat UCB Deferred for (Private) for infusion INC 10mg/ml submission of Limited. B-23 Infusion Dy. No: 130 IV infusion original duly S.I.T.E Karachi. Each ml of solution dated 20-09- legalized COPP contains: 2013 by the concerned M/s UCB Lacosamide….10mg (UCB 100,000/- embassy of Pharma SA specs) dated 20-09- Pakistan. Chemin du (Antiepileptic) 2013 foriest B 1420 20ml Braine-Alleud Rs.10,818/- Belgium 32. M/s Pfizer Xeljanz Form-5 (A) Xeljanz by Registration Pakistan Limited, Tablet PF Prism CB Board deferred 12 Dockyard Each tablet contains: Dy. No: 170 the application for Road, West Tofacitinib…….5mg dated 27-09- submission of Wharf, Karachi. (Factor Xa Inhibitor) 2013 following. Storage conditions are not Pfizer 50,000/- as per innovator. Manufacturing dated 27-09- COPP is issued by Deutschland 2013 Swissmedic and GmbH Not does not provide Betriebsstatte mentioned. information of Freiburg manufacturing / Mooswaldallee packaging to be 179090 Freiburg done at USA. Germany. Label shows the product is manufactured in Ireland while as per application it is manufactured at Germany and USA.

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Last Inspection Report conducted by the concerned Regulatory Authority for manufacturing process at USA. The approval status in EMA is also required. 33. M/s Pfizer Xeljanz Form-5 (A) Xeljanz 10mg Registration Pakistan Limited, Tablet is not FDA Board deferred 12 Dockyard Each tablet contains: Dy. No: 169 approved. the application for Road, West Tofacitinib…….10mg dated 27-09- submission of Wharf, Karachi. (Factor Xa Inhibitor) 2013 following. Storage conditions are not Pfizer 50,000/- as per innovator. Manufacturing dated 27-09- COPP is issued by Deutschland 2013 Swissmedic and GmbH Not does not provide Betriebsstatte mentioned. information of Freiburg manufacturing / Mooswaldallee packaging to be 179090 Freiburg done at USA. Germany. Label shows the product is manufactured in Ireland while as per application it is manufactured at Germany and USA. Last Inspection Report conducted by the concerned Regulatory Authority for manufacturing process at USA. The approval status in EMA is also required. 34. M/s Bayer Stivarga (Regorafenib) Form-5 (A) GMP Approved subject Pakistan (Pvt.) 40mg film coated tablets. Dy. No: 370 inspection to compliance of Limited. Film coated tablets. dated 03-12- conducted Import Policy for Each film coated tablet 2013 December 14 Finished Drugs M/s Bayer contains. 50,000/- to 16, 2010 and confirmation Pharma AG Regorafenib……40mg dated 03-12- by German of storage facility 51368 (Regorafenib is a protein 2013 Authority. of importer. Leverkusen kinase inhibitor with the To be Germany. ATC code L01XE21.) submitted latter.

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35. M/s Abbott Nucleo CMP Forte Form-5 D GMP issued Deferred for Laboratories, Capsules. Dy. No: 314 on February submission of Karachi. Capsules. dated 11-11- 09-2011, by availability in Each Capsule contains. 2013 Spanish reference M/s Ferrer Cytidine……5mg 50,000/- Government countries and Internacional. Uridine…..1.33mg dated 11-11- Stability Studies S.A. Joan (Musculoskeletal System) 2013 conducted under Buscalla 1-9 To be the Zone IV-A 08173-Sant forwarded. conditions as per Cugat del Valles ICH / WHO (Barcelona) guidelines. Spain 36. M/s Sanofi- Lyxumia. Form-5 A Lyxumia Deferred for eventis Pakistan Solution of injection. Dy. No: 763 (Sanofi clarification as Limited. Plot Each dose of 0.2 ml dated 28-06- Aventis EMA FDA approval is No.23, Sector contains. 2013 approved) delayed sighting No.22, Korangi Lixisenatide……20mg 100,000/- internal data from Industrial Area s (ATC code: A10BX10) dated 28-06- cardiovascular Plot No.23, 2013 risks study. Sector No.22, 1’s/ Korangi Rs.7506.8 Industrial Area Karachi.

M/s Sanofi- Aventis Deutschland GmbH, Industriepark Hoechst 65926 Frankfurt am Main Germany 37. M/s Sanofi- Lyxumia. Form-5 A Lyxumia Deferred for eventis Pakistan Solution of injection. Dy. No: 761 (Sanofi clarification as Limited. Plot Each dose of 0.2 ml dated 28-06- Aventis EMA FDA approval is No.23, Sector contains. 2013 approved) delayed sighting No.22, Korangi Lixisenatide……10mg 100,000/- internal data from Industrial Area s (ATC code: A10BX10) dated 28-06- cardiovascular Plot No.23, 2013 risks study. Sector No.22, 1’s/ Korangi Rs.7506.8 Industrial Area Karachi.

M/s Sanofi- Aventis Deutschland GmbH, Industriepark Hoechst 65926

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Frankfurt am Main Germany

38. M/s Sanofi- Lyxumia. Form-5 A Lyxumia Deferred for eventis Pakistan Solution of injection. Dy. No: 762 (Sanofi clarification as Limited. Plot Lyxumia® Pen-injector is dated 28-06- Aventis EMA FDA approval is No.23, Sector available in two different 2013 approved) delayed sighting No.22, Korangi dosage strengths: 10µg and 100,000/- internal data from Industrial Area s 20µg per 0.2ml dated 28-06- cardiovascular Plot No.23, administration volume. 2013 risks study. Sector No.22, Body and cap are provided 1+1=2’s/ Korangi in two different colors: Rs.15,013.6/- Industrial Area green (10µg) and burgundy Karachi. (20µg) (ATC code: A10BX10)

M/s Sanofi- Aventis Deutschland GmbH, Industriepark Hoechst 65926 Frankfurt am Main Germany 39. M/s Novartis Veltezom 3.5mg/Vial Form-5 Velcade Approved subject Pharma Powder for Solution for Dy. No: 296 Millennium to compliance of (Pakistan) Injection. dated 31-03- Pharms Import Policy for Limited Vial Injectable. 2014 Finished Drugs Each Vial contains. 50,000/- and confirmation Brotezomib……3.5mg dated 25-07- of storage facility M/s Sandoz (Antineoplastic agent) 2013 of importer. Onco Therapies 1’s/ Limited Plot No. Rs.20,317/- 284, Bommasandra- Jigani Link Road , Industrial Area, AnekalTaluk, Bangalore 560, 105 India. 40. M/s Relvar Ellipta Form-5A Approved subject GlaxoSmithKline Dry Powder Inhaler Dy. No: 275 to compliance of Pakistan Limited Each pre-dispensed dose dated 04-04- Import Policy for 35-Dockyard contains. 2014 Finished Drugs Road, West Fluticasone 50,000/- and confirmation Wharf, Karachi. furoate…….100mcg dated 04-04- of storage facility Vilanterol (as 2014 of importer. trifenatate)…25mcg M/s Glaxo (Potent Corticosteroid plus Operations UK long acting beta-2

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Limited, Ware adrenergic agonist for the UK maintenance treatment of asthma and COPD)

41. M/s Relvar Ellipta Form-5A Approved subject GlaxoSmithKline Dry Powder Inhaler Dy. No: 275 to compliance of Pakistan Limited Each pre-dispensed dose dated 04-04- Import Policy for 35-Dockyard contains. 2014 Finished Drugs Road, West Fluticasone 50,000/- and confirmation Wharf, Karachi. furoate…….200mcg dated 04-04- of storage facility Vilanterol (as 2014 of importer. trifenatate)…25mcg M/s Glaxo (Potent Corticosteroid plus Operations UK long acting beta-2 Limited, Ware adrenergic agonist for the UK maintenance treatment of asthma and COPD) 42. M/s Anoro Ellipta Form-5A Approved subject GlaxoSmithKline Dry Powder Inhaler Dy. No: 693 to compliance of Pakistan Limited Each pre-dispensed dose dated 18-09- Import Policy for 35-Dockyard contains. 2014 Finished Drugs Road, West Umeclidinium…….62.5mcg 50,000/- and confirmation Wharf, Karachi. Vilanterol (as dated 18-09- of storage facility trifenatate)…25mcg 2014 of importer (Long acting muscarinic Will be M/s Glaxo antagonist (LAMA), and a submitted Operations UK long-acting beta-2 agonist later Limited, Ware (LABA) UK 43. M/s Incruse Ellipta Form-5A Approved subject GlaxoSmithKline Dry Powder Inhaler Dy. No: 234 to compliance of Pakistan Limited Each pre-dispensed dose dated 15-12- Import Policy for 35-Dockyard contains. 2014 Finished Drugs Road, West Umeclidinium (equivalent 50,000/- and confirmation Wharf, Karachi. to 74.2 mcg of umecidinium dated 15-12- of storage facility bromide)…….62.5mcg 2014 of importer (Long acting muscarinic Will be M/s Glaxo antagonist (LAMA) submitted Operations UK later Limited, Ware UK 44. M/s Mazaton Epiduo Gel Form-5A Deferred for Pharmaceuticals Gel Dy. No: 132 submission of (Pvt) Ltd. Each Gel Contains. dated 01-12- Stability Studies 720-X, Phase III, Adapalene……………0.1% 2014 conducted under D.H.A, Lahore Benzoyl Peroxide…… 2.5% 50,000/- the Zone IV-A 15gm/ conditions as per M/s Laboratories Rs.1500/- ICH / WHO Galderma Z.I. guidelines. Montdesir 74540 Alby sur Cheran-

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France

Case No. 02: Anomaly Cases Additional Section

EVALUATOR IV

Oral Dry Powder Suspension (General) 45. M/s Bosch QMETEM PLUS Form 5 Co-Artesiane Pharmaceuti DS Rs. 20,000/- Suspension Approved cals (Pvt.) SUSPENSION dated 11-01- (Slachthuisstra Ltd, Bosch 2011 & 09- at, Belgium) House, 221, Each 5 ml 09-2013 Sector 23, contains Korangi Artemether (MS) Pack of Gen-M DS Industrial 30 mg 30 ml Rs Suspension Area, Lumefantrine 150/- (Genix) Karachi. (MS) 180 mg 60 ml Rs Additional 300/- Section Antimalarial approved in 236th meeting (Manufacture of CLB Specification) 46. -do- Quinoflox-G Form 5 Ciproxin Rejected because the formulation is not 125mg/5ml Rs. 20,000/- (Bayer) approved by any reference regulatory Suspension dated 17-10- authorities in proposed strength and also 2014 rejected in 250th Meeting of Registration Each 5 ml Novidat (Sami) Board.

contains Pack of

Ciprofloxacin as 60 ml & HCl 125 mg 90 ml as per Ciprofloxacin SRO taste masked granules 35%

(Manufacture Specification)

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47. -do- Quinoflox Form 5 Ciproxin Rejected because the formulation is not 125mg/5ml Rs. 20,000/- (Bayer) approved by any reference regulatory Suspension dated 06-08- authorities in proposed strength and also 2011 & 14- rejected in 250th Meeting of Registration Each 5 ml 05-2013 Mytil (Wilson) Board.

contains

Ciprofloxacin Pack of HCl eq to 60 ml & Ciprofloxacin 90 ml as per USP 125 mg SRO

(Manufacture Specification) 48. -do- Quinoflox Form 5 Ciproxin Deferred for revision of the formulation 250mg/5ml Rs. 20,000/- (Bayer) of proposed product as per innovator Suspension dated 06-08- brand which is composed of 2011 & 09- ciprofloxacin microcapsules and diluent Each 5 ml 09-2013 Mytil (Wilson) which are mixed prior to dispensing . The components of the suspension have contains the following compositions: Ciprofloxacin Pack of  Microcapsules–ciprofloxacin, HCl eq to 30 ml & povidone, methacrylic acid Ciprofloxacin 60 ml as per copolymer, hypromellose, USP 250 mg SRO magnesium stearate, and Polysorbate 20. (Manufacture  Diluent–medium-chain triglycerides, Specification) sucrose, lecithin, water, and strawberry flavor.  Five (5) mL of 5% suspension contains approximately 1.4 g of sucrose and 5 mL of 10% suspension contains approximately 1.3 g of sucrose.

The Board further advised to evaluation cell to evaluate and verify the nature and composition of diluent in other SRAs. 49. -do- Quinoflox-G Form 5 Ciproxin Deferred for revision of the formulation 250mg/5ml Rs. 20,000/- (Bayer) of proposed product as per innovator Suspension dated 17-10- brand which is composed of 2014 ciprofloxacin microcapsules and diluent Each 5 ml Mytil (Wilson) which are mixed prior to dispensing . The components of the suspension have contains Pack of the following compositions: Ciprofloxacin as 60 ml &  Microcapsules–ciprofloxacin, HCl 250 mg 90 ml as per povidone, methacrylic acid SRO copolymer, hypromellose, Ciprofloxacin magnesium stearate, and Polysorbate taste masked 20.

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granules 35%  Diluent–medium-chain triglycerides, sucrose, lecithin, water, and (Manufacture strawberry flavor. Specification)  Five (5) mL of 5% suspension contains approximately 1.4 g of sucrose and 5 mL of 10% suspension contains approximately 1.3 g of sucrose.

The Board further advised to evaluation cell to evaluate and verify the nature and composition of diluent in other SRAs. 50. -do- Qumic Form 5 Levaquin Decided as per decision of 250th 125mg/5ml Rs. 20,000/- 125mg/5ml meeting of RB that Suspension dated 20-06- Solution,USFD  Applicants shall either revise their 2014 A formulation to Oral Solution dosage Each 5 ml form, if not registered previously contains Pack of and if manufacturing facility is Levofloxacin as 60 ml & Levanic approved by CLB (new registration Hemihydrate 125 as per SRO (Global) application with complete fee) or, mg  Shall submit Pharmaceutical development data including stability Antibiotics within six months period. (Manufacture  For already registered drugs, same Specification) procedure as mentioned above (at Sr. No. i & ii) shall be adopted. Otherwise showcause notice shall be issued for deregistration of drug in this formulation.  All such application shall be processed on priority basis.

51. -do- Qumic Form 5 Not available Rejected as the formulation is not 250mg/5ml Rs. 20,000/- internationally approved by reference drug regulatory Suspension dated 20-06- agencies. 2014 Each 5 ml Levanic contains Pack of (Global) Levofloxacin as 60 ml & Hemihydrate 250 as per SRO mg

(Manufacture Specification)

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52. -do- Zolrest Form 5 MHRA 100mg/5ml Rs. 20,000/- approved Approved Suspension dated 23-05- Linezolid 2011 & 09- 100mg/5ml Each 5 ml 09-2013 (Pfizer, UK) contains Linezolid (MS) Pack of …..100 mg 60 ml & 150 Nezocin ml (Brookes) Oxazolidinone / as per SRO antibacterial

(Manufacture Specification)

Evaluator IV Oral Dry Powder Suspension (General)

53. M/s Caliph Fosfo Dry Form 5 FOSFOCINA Deferred for confirmation of Pharmaceutic Suspnesion Rs. 20,000/- (Laboratorios approval status by reference als (Pvt.) Ltd, vide Dy. No. ERN, S.A. regulatory authorities. Plot # 17, Each 5 ml (after 905 dated 13- Barcelona. Special reconstitution) 04-2012 España) Industrial contains Zone, Fosfomycin Pack of Focin Dry Risalpur, calcium eq to 60 ml / Rs. Suspension KPK. fosfomycin 250 97.62 (Tabros) mg

Broad Spectrum antibiotic

(Manufacture Specification) 54. -do- Fansid Form 5 Fansidar WHO Approved with change of brand Suspension Rs. 20,000/- prequalified in name as it resembles with the (Dy. 3416) South Africa existing one. Each 5 ml 25-02-2015 (Roche) contains Sulphadoxine Pack of Fansidar USP 500 mg 15 ml / Rs. Suspension Pyremethamine 15.526 (Roche) USP 25 mg 30 ml / Rs. 46.58 Suphonamide /Diaminopyrimidine

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(Manufacture Specification) EVALUATOR IV Veterinary Dry Powder Injection Vials (Penicillin) 55. M/s I-PSTREP Form 5 In the list of Approved International Injection Rs. 20,000/- approved UK Pharma Labs, Supension (Dy. 73) Veterinary Raiwind Road, 09-08-2012 & medicine 1 km Toward Each ml contains 26-06-2014 Directory Kahna, Lahore Procain Penicillin BP 200 mg Veterinary Streptomycin Strepto-Pen Dry Powder Sulphate BP 250 Injectable Injection mg Suspension Vials (Alina) (Penicillin) (Manufacture Specification) GMP compliant additional section 56. -do- I-PRO-STREP Form 5 UK approved Approved Injection Rs. 20,000/- marketing Supension (Dy. 71) authorization 09-08-2012 & to Zoetis UK Each ml contains 26-06-2014 Limited Procain Penicillin BP 200 mg Neo Strep-Pen Streptomycin Injectable Sulphate BP 160 Suspension mg (Nawan)

(Manufacture GMP compliant Specification) additional section 57. -do- IPS Injectable Form 5 Fatromiycine – S Approved Suspension Rs. 20,000/- ( Fatro S.p.A., Italy) (Dy. 65) (Greece) Each ml contains 09-08-2012 & 26-06-2014 Benzathine Penicillin G BP 100,000 I.U Pencin-La Procaine Injection Penicillin G BP (Star 150,000 I.U Laboratories) Dihydrostreptomy cin Sulfate As GMP compliant additional

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base) BP 200 mg section

(Manufacture Specification) 58. -do- I-PENSTREP- Form 5 Penstrep 20/25 Approved 450 Injectable Rs. 20,000/- (Kepro, (Dy. 37) Holland) Each ml contains 19-01-2015 Pro-strep Procaine injection (Leads Penicillin G BP Pharma) 200,000 I.U Dihydrostreptomy GMP compliant cin Sulfate As additional base) BP 250 mg section

(Manufacture Specification)

Evaluator IV Capsule (General) Section

59. M/s Caliph Pregab Capsule Form 5 MHRA Approved Pharmaceutic 150 mg Rs. 20,000/- approved als (Pvt.) Ltd, (Dy. 3543) Capsule Alzain Plot # 17, Each hard gelatin 20-05-2015 150 mg Special capsule contains manufactured Industrial Pregabalin 150 Pack of by Caduceus Zone, mg 2 x 7’s as per Pharma Risalpur, SRO Limited.UK KPK. GABA Analogue Gabica (Getz) (Manufacture Specification) 60. -do- Pregab Capsule Form 5 MHRA Approved 75 mg Rs. 20,000/- approved (Dy. 3531) Capsule Alzain Each hard gelatin 13-04-2015 75 mg capsule contains manufactured Pregabalin 75 mg Pack of by Caduceus 2 x 7’s as per Pharma GABA Analogue SRO Limited, UK.

(Manufacture Gabica (Getz) Specification)

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61. -do- Pregab Capsule Form 5 MHRA Approved 100 mg Rs. 20,000/- approved (Dy. 3529) Capsule Alzain Each hard gelatin 13-04-2015 100 mg capsule contains manufactured Pregabalin 100 Pack of by Caduceus mg 2 x 7’s as per Pharma SRO Limited, UK. GABA Analogue Gabica (Getz) (Manufacture Specification) 62. -do- Pregab Capsule Form 5 MHRA Approved 50 mg Rs. 20,000/- approved (Dy. 3542) Capsule Alzain Each hard gelatin 20-04-2015 50 mg capsule contains manufactured Pregabalin 50 mg Pack of by Caduceus GABA Analogue 2 x 7’s as per Pharma (Manufacture SRO Limited, UK. Specification) Gabica (Getz)

Evaluator IV Capsule (General) Section

63. M/s FAAS Zebact Capsules Form 5 THROB Decided to follow decision of 250th Pharmaceutic 500 mg Rs. 20,000/- Capsules, meeting of RB that als (Pvt.) Ltd, (Dy. 294) BioLabs India i. Applicants shall either revise their F-748, S.I.T.E, Each capsule 22-06-2014 formulation to tablet dosage form, if not Karachi contains Zetro (Getz) registered previously and if Azithromycin (as Pack size of manufacturing facility is approved by Dihydrate) USP 1 x 10’s / CLB (new registration application with complete fee) or, eq to Price as per ii. Shall submit Pharmaceutical azithromycin … SRO development data including stability, 500mg bioavailability/ bioequivalence studies within six months period. (USP iii. For already registered drugs, same Specification) procedure as mentioned above (at Sr. No. i & ii) shall be adopted. Otherwise show cause notice shall be issued for deregistration of drug in this formulation. iv. All such application shall be processed on priority basis.

Sachet (General)

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64. -do- ULCI LOC Form 5 FDA approved Deferred as formulation is under INSTA SACHET Rs. 20,000/- Zegerid review 20 mg (Dy. 98) manufactured 14-07-2015 by Salix Each Sachet Pharmaceutical contains Pack size of s i. Omeprazole 1 x 10’s USP … 20 Sachet Price Risek Insta mg as per SRO (Getz)

ii. Sodium

Bicarbonate USP 1680 mg

(USP Specification) 65. -do- ULCI LOC Form 5 FDA approved Deferred as formulation is under INSTA SACHET Rs. 20,000/- Zegerid review 40 mg (Dy. 99) manufactured 14-07-2015 by Salix Each Sachet Pharmaceutical contains Pack size of s i. Omeprazole 1 x 10’s USP … 40 Sachet Price Risek Insta mg as per SRO (Getz)

ii. Sodium

Bicarbonate USP 1680 mg

(USP Specificatio

Evaluator I Infusion LVP 66. M/s Revive Revasol HD Form 5 - Deferred for confirmation of Pharmakon, 10 (Ringer Lactate + (29.06.15) approval status by reference drug Km , Raiwind Dextrose 5%) IV Dy. No. 4154 regulatory authority road, Lahore. infusion Rs. 20000/- Each 100ml Rs.84.00/1000 Infusion LVP contain: Calcium ml bottle w/o approved in Chloride set st 241 meeting 2H2O…27mg New License of CLB Potassium Chloride …40mg Sodium

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Chloride…600mg Sodium Lactate…310mg Dextrose anhydrous…5gm WFI…. Q.s to 100ml Isotonic volume expander, electrolyte replacement USP Specifications

67. -do- Revasol HD Form 5 - Deferred for confirmation of (Ringer Lactate + (29.06.15) approval status by reference drug Dextrose 5%) IV Dy. No. 4148 regulatory authority infusion Rs. 20000/- Each 100ml Rs.59.00/500 contain: Calcium ml bottle w/o Chloride set 2H2O…27mg New License Potassium Chloride …40mg Sodium Chloride…600mg Sodium Lactate…310mg Dextrose anhydrous…5gm WFI…. Q.s to 100ml Isotonic volume expander, electrolyte replacement USP Specifications

68. -do- Revasol H Form 5 - Deferred for confirmation of (Hartmann’s (29.06.15) approval status by reference drug solution) IV Dy. No. 4153 regulatory authority infusion Rs. 20000/- Each 100ml Rs.56.00/500 contain: Calcium ml bottle Chloride New License 2H2O…27mg

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Potassium Chloride …40mg Sodium Chloride…600mg Sodium Lactate…310mg WFI…..Q.s to 100ml Isotonic volume expander, electrolyte replacement B.P Specifications

69. -do- Revasol H Form 5 - Deferred for confirmation of (Hartmann’s (29.06.15) approval status by reference drug solution) IV Dy. No. 4142 regulatory authority infusion Rs. 20000/- Each 100ml Rs.77.00/1000 contain: Calcium ml bottle Chloride New License 2H2O…27mg Potassium Chloride …40mg Sodium Chloride…600mg Sodium Lactate…310mg WFI…. Q.s to 100ml Isotonic volume expander, electrolyte replacement B.P Specifications

70. M/s SAMI MIDAZ 5mg/5ml Form 5 UK: Approved. Pharmaceutical Injection Rs. 20,000/- Midazolam Condition will be mentioned in s (Pvt.) Each 5ml contains: (10-09-2014) Solution for registration letter that firm will Limited, F-95, Midazolam Injection or purchase and perform installation Off. Hub River USP…….……..5 Rs. 1320 for Infusion and operational Road, S.I.T.E., mg 10 ampoules (Accord qualifications of TOC analyser and Karachi-75730 (Benzodiazepine) Healthcare) liquid particle USP Specs. counter in six months time. (Liquid Dormicum

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Injection Regn. No. Psychotropic) 014929 (Martin approved in Dow) 236th meeting of CLB Grant of additional section – Liquid Injection (Psychotropic) (08-09-2014) VERY GOOD

71. -do- Doctile 3gm Form-5 Not Confirmed Approved Sachet 19-08-14 Smecta (Atco) Each sachet Dy.No.152 Very good, contains: Rs.20,000/- Panel Dioctahedral As per DPC recommends all smectite…… the additional ……3 gm sections as per (Antidiarrheal) approved layout plan. (24-06-14 72. M/s WelWrd Clarithrowrd Form 5 BNF: Klaricid Approved with condition that firm Pharmaceutical 500mg 13-08-2011 (Abbott will import the ready to fill s Injection Rs.8,000/- Healthcare) lyophilize powder and will not claim Plot # 03, Each Vial (Dy. No. Klaricid I.V the product as lyophilized. Block-A, contains:- 11)+Rs. (Abbot) Phase- Clarithromycin 12000/- (25- Good level of I-II, Industrial …500 mg 09- compliance Estate Hattar (Anti-Infective 14) with Drug) As Fixed by GMP guidelines (Manufacturer’s Govt (25.07.13), Spec.s) routine GMP inspection by area FID 73. -do- Azithrowel Form 5 Zedbac (Aspire Approved with condition that firm 500mg 13-08-2011 Pharma) UK will import the ready to fill Injection Rs.8,000/- Azimycin lyophilize powder and will not claim Each Injection (Dy. No. (Mediceena) the product as lyophilized. contains:- 09)+Rs. Not provided Azithromycin 12000/- (25- (lyophilized)…50 09- 0 14) As Fixed mg by (Anti-Infective Govt Drug) (USP Spec.s)

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74. M/s Tabros Progrel AP Tablet Form 5 Approved Pharma Pvt Ltd, Karachi Each cover tablet Rs. 15,000 contains:- dated 30-03- Inner Enteric 2015 & coated tablet Rs.5000 dated containing 08-12-2014 Aspirin …75mg Outer (cover) Dy. No. 440 tablet contains R&I clopidogrel …75mg Price: 200/- Platlet per pack 1x aggregation 10’s Inhibitor Price: 400/- Manufacturer’s per pack 2x specifications 10’s 75. M/s Searle IV Esomac 40mg Form 5 Nexium 40mg Approved Solutions (Pvt) Capsules FDA approved Ltd, Formerly Rs. 20,000/- Mac & Rains Each Capsule Esso 40mg by Lahore contains: Dy. No. 2691 M/s Shaigan Enteric coated R&I Dated pellets of 30-12-2014 Esomeprazole Magnesium USP Price: 265/- equivalent to 14 capsules esomeprazole Source of ……….… 40mg pellets M/s Vision Proton Pump Pharma, Inhibitor Islamabad

Manufacturers specifications 76. -do- Esomac 20mg Form 5 Nexium Approved Capsules 20mgFDA Rs. 20,000/- approved Each Capsule contains: Dy. No. 2690 Esso 20mg by Enteric coated R&I Dated M/s Shaigan pellets of 30-12-2014 Esomeprazole Magnesium USP Price: 160/- equivalent to 14 capsules esomeprazole Source of ……….… 20mg pellets M/s Vision

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Proton Pump Pharma, Inhibitor Islamabad

Manufacturers specifications 77. -do- Omicarb Form 5 Rejected because the formulation 20/1100mg doesn’t exist in the reference Powder Sachet Rs. 20,000/- regulatory authorities in proposed strength and also rejected in 250th Each sachet Dy. No. 1011 Meeting of Registration Board. contains(4gm):- R&I Dated Omeprazole 26-09-2014 …20mg Sodium bicarbonate Price: 120/- ….1100mg 10 sachet

PPI & Antacid

Manufacturers specifications 78. -do- Azimac Dry Form 5 Deferred for confirmation of Suspension approval status by reference drug Rs. 20,000/- regulatory authorities and me too Each 5ml status. contains:- Dy. No. 2688 Azithromycin R&I Dated Dihydrate eq. to 30-09-2014 azithromycin…20 0mg Price: 165/15ml Macrolide bottle USP specifications 79. -do- Tacromac Gel Form 5 Deferred for Each gram Rs. 20,000/-  Specifications require justifications contains:- as some are USP and other are Flurbiprofen…50 Dy. No. 2684 manufacturer in the finished mg R&I Dated product specifications. 30-09-2014  confirmation of approval status NSAID by reference drug regulatory Price: 98.67, authorities and me too status Manufacturer 226.55/20gm, specifications 50gm.

80. -do- Azimac capsules Form 5 BNF Approved Azithromycin Each capsule Rs. 20,000/- 250mg capsules. contains:-

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Azithromycin Dy. No. 2685 Acasia 250mg Dihydrate eq. to R&I Dated Capsule by M/s azithromycin…… 30-09-2014 Nexpharm 250mg Price:270/10 Macrolide capsules.

USP specifications

81. -do- Piroximac Gel Form 5 Deferred for  Specifications require justifications Each gram Rs. 20,000/- as some are USP and other are B.P contains:- in the finished product Piroxicam…5mg Dy. No. 2685 specifications. R&I Dated  confirmation of approval status NSAID 30-09-2014 by reference drug regulatory authorities and me too status B.P Price:270/10 specifications capsules.

82. -do- Omicarb Form 5 Rejected because the formulation 40/1100mg doesn’t exist in the reference Powder Sachet Rs. 20,000/- regulatory authorities in proposed strength and also rejected in 250th Each sachet Dy. No. 1009 Meeting of Registration Board. contains(4gm):- R&I Dated Omeprazole 26-09-2014 …40mg Sodium bicarbonate Price: 120/- ….1100mg 10 sachet

PPI & Antacid

Manufacturers specifications 83. M/s Oakdal Ditralka Syrup Form 5 Not confirmed Deferred for Pharma. Each 5ml 17-11-2014 Citralka (Pfizer)  For confirmation of approval Plot#114 contains:- Rs. 20,000/- Grant of DML status by reference drug Industrial Disodium (Dy. No. 432) by regulatory authorities . Estate Hydrogen Citrate As Per SRO/ way of  Final notice for removal of Hayatabad, …1.315gm 60ml formulation deficiencies / observations. Peshawar. (Urinary recommended Alkaliniser) (10.05.14) (Manufacturer’s Spec.s) 84. -do- Triconyl Syrup Form 5 Not confirmed Deferred for Each 5ml 17-11-2014 Tesmic (Zafa)

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contains:- Rs. 20,000/- Grant of DML  confirmation of approval status Terbutaline (Dy. No. 434) by by reference drug regulatory Sulphate As Per SRO/ way of authorities (USP)…0.3mg 60ml formulation  Final notice for removal of (Bronchodialator) recommended deficiencies /observations. (Manufacturer’s (10.05.14)  Internationally it is available as Spec.s) 0.3mg/ml. 85. -do- Ferrocid 200/0.5 Form 5 Not confirmed Deferred for mg Capsule 17-11-2014 Ferrocap (CCL)  approval status by reference drug Each capsule Rs. 20,000/- Grant of DML regulatory authorities. contains:- (Dy. No. 431) by  Source of pellets, GMP certificate Ferrous Sulphate As Per SRO/ way of of Source, COA, and Stability …200mg 3×10’s formulation Studied conducted according to Folic Acid… recommended zone IV-a conditions and fee in 0.5mg (10.05.14) case of import of pellets. (Heamatonic)  Final notice for removal of (Manufacturer’s deficiencies/observations. Spec.s) 86. -do- Mercin 135 mg Form 5 Not confirmed Deferred for: Capsule 17-11-2014 Not confirmed  approval status by reference drug Each capsule Rs. 20,000/- Grant of DML regulatory authorities. contains:- (Dy. No. 428) by  Me-too status Mebeverine HCl As Per SRO/ way of  Final notice for removal of (B.P)…135mg 1×10’s formulation deficiencies/observations. (Antispasmodic) recommended (Manufacturer’s (10.05.14) Spec.s) 87. -do- Nfacon Form 5 Not confirmed Deferred for Suspension 17-11-2014 Infacol (Spenser  approval status by reference drug Each 5ml Rs. 20,000/- Pharma) Grant regulatory authorities . contains:- (Dy. No. 438) of DML by  Final notice for removal of Simethicone As Per SRO/ way of deficiencies /observations. (USP)…50mg 60ml formulation Dicyclomine HCl recommended (BP)… 5mg (10.05.14) (Antispasmodic/a nt iflatulent) (Manufacturer’s Spec.s) 88. M/s. Himont 1. Toraflam Tablets 1. Form-5 2. Manufacturer’s Pharmaceuticals 2. Coated tablet 3. Fast track 3. LORICAM By Approved (Pvt) Ltd., 17- Each coated tablet Rs.78/ per 10’s SAFFRON Km, Ferozepur contains:- tablet. 4. PHARMACEUT Road, Lahore Lornoxicam 11/7/2013, ICAL …….4mg 4. Non 8973 (R&I) 5. COMPANY steroidal anti- 11/07/2013 Rs. inflammatory drug 60,000/-

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Manufacturer’s Specifications

89. -do- 1. Toraflam Tablets 1. Form-5 2. Manufacturer’s 2. Coated tablet 3. Fast track 3. LORICAM By Each coated tablet Rs.130/ per SAFFRON Approved contains:- 10’s tablet. 4. PHARMACEUT Lornoxicam 8/7/2013, 8972 ICAL …….8mg 4. Non (R&I) 5. COMPANY steroidal anti- 11/07/2013 Rs. inflammatory drug 60,000/-

Manufacturer’s Specifications 90. M/s Weather Moco Sachet Form-5 Movicol Sachet Folds Each sachet Dy No. 76 in Australia Approved Pharmaceutical contains:- dated 31-08- Movcol Sachet s, Plot # 69/2, Polyethylene 2015 by M/s Genix Phase II, Glycol…13.125g Rs.20,000 Pharma Industrial m Sodium As per SRO. Estate, Hattar, Chloride…….350 KPK. .7mg Potassium section of Chloride sachet vide …46.6mg No.F.3-6/2007- Sodium Lic (Vol-I) Bicarbonate…178 dated 03-04- .5mg 2015. Osmotically acting Laxatives Manufacturer’s Specifications. 91. -do- Dipesin Sachet Form-5 WHO Approved Each sachet Dy No. 75 Formulation contains:- dated 31-08- Dihydroartmisini 2015 Diphos powder n…15mg Rs.20,000 15/120mg by Pepraquine As per SRO. M/s Genix. Phosphate…….1 20mg Anti Malarial Manufacturer’s Specifications. 92. -do- Esowiz Sachet Form-5 FDA Nexium Each sachet Dy No. 74 10mg/pack as contains:- dated 31-08- base in the form Approved Esomeprazole As 2015 of delayed magnesium Rs.20,000 release pellets Trihydrate enteric As per SRO. Axesom 10mg

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coated Source of Sachet pellets…10mg Pellets M/s approved in 243 Proton pump Vision M by M/s Inhibitor Pharmaceutic Highnoon Manufacturer’s als, Kahuta Specifications. triangle, Islamabad.

93. -do- Ferrifold Form-5 Not Confirmed Dedeferred for Injection Dy No. 73 Feriject  Verification of the product is in Each ml dated 31-08- injection liquid vial form, requires section contains:- Iron as 2015 50mg/ml by confirmation. Ferric Rs.20,000 M/s RG  International availability is not Carboxymaltose As per Pharma. provided by the firm. …50mg SRO/15ml Not provided vial. Manufacturer’s Specifications. 94. M/s Welwrd Prewel Capsule Form-5 LYRICA Pharmaceutical 75mg Dy No. 334 Capsules (25, Approved s, Hattar Each capsule dated 15-07- 50, 75, 100, contains:- 2014 150,200, 225 pregabalin….75m Rs.20,000 and 300mg) g As per SRO US FDA (Gaba Analogue) GABICA Capsules (50, (Manufacture 75, 100, 150 Specification) and 300mg) Getz

Case No.03:- a) Grant of registrations for routine cases (Local) EVALUATOR IV

Tablet (General) Section 95. M/s Well & Tablet Zink 20 Form 5 WHO Approved Well (Pvt.) mg Rs. 20,000/- prequalified Ltd, Plot # 07, vide Dy. No. Zincfant Tablet Street # S-8, Each dispersible 380 dated 14- 20 mg National tablet contains 06-2012 manufactured Industrial 54.9 mg zinc and by Laboratoires Zone, RCCI, sulfate Dy. No. 3939 Pharmaceutique Rawat, monohydrate dated 17-06- s Rodael - Islamabad. equivalent to 20 2013 France

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mg of zinc elemental Pack of Tablet Zinxus 3 x 10’s as per (Ferozsons) Antidiarrheal SRO The firm was (USP Application found GMP Specification) swapped as compliant as per DRAP’s per inspection Policy Board report dated 11- decision 11-2014. Tablet (General) 96. M/s Tablet Bestegral- Form 5 International Deferred for confirmation of Remington A 5/75 Rs. 20,000/- availability not approval status by reference drug Pharmaceut vide Dy. No. provided regulatory authorities and me too icals (Pvt.) Each film coated 676 dated 28- status. Ltd, 18-km tablet contains 03-2011 Tablet Multan Prasugrel HCl eq. and EFIGREL 5/75 Road, to Prasugrel … Dy. No. 9272 (CCL) Lahore. 5.0 mg dated 30-07- Aspirin USP… 2013 The panel vide 75.0 mg inspection Pack of report dated 9th Platelet Inhibitor 14’s, 20’s & July 2015 & NSAID 28’s as per recommended leader price the firm for (Manufacture grant of cGMP Specification) certificate in respect of all sections. 97. -do- Tablet Bestegral- Form 5 International Deferred for confirmation of A 10/150 Rs. 20,000/- availability not approval status by reference drug Vide Dy. No. provided regulatory authorities and me too Each film coated 678 dated 28- status. tablet contains 03-2011 and Tablet Prasugrel HCl eq. Dy. No. 9272 EFIGREL to Prasugrel … dated 30-07- 10/150 (CCL) 10.0 mg 2013 Aspirin USP… The panel vide 150.0 mg Pack of 14’s, inspection 20’s, 28’s as report dated 9th Platelet Inhibitor per leader July 2015 & NSAID price recommended the firm for (Manufacture grant of cGMP Specification) certificate in respect of all sections.

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98. -do- Tablet Bestegral- Form 5 International Deferred for confirmation of A 5/150 Rs. 20,000/- availability not approval status by reference drug Vide Dy. No. provided regulatory authorities and me too Each film coated 679 dated 28- status. tablet contains 03-2011 and Tablet Prasugrel HCl eq. Dy. No. 9274 EFIGREL to Prasugrel … dated 30-07- 5/150 (CCL) 5.0 mg 2013 Aspirin USP… The panel vides 150.0 mg Pack of 14’s, inspection 20’s, 28’s as report dated 9th Platelet Inhibitor per leader July 2015 & NSAID price recommended the firm for (Manufacture grant of cGMP Specification) certificate in respect of all sections. 99. -do- Tablet Bestegral- Form 5 International Deferred for confirmation of A 10/75 Rs. 20,000/- availability not approval status by reference drug Vide Dy. No. provided regulatory authorities and me too Each film coated 675 dated 28- status. tablet contains 03-2011 and Tablet Prasugrel HCl eq. Dy. No. 9273 EFIGREL to Prasugrel … dated 30-07- 10/75 (CCL 10.0 mg 2013 Aspirin USP… The panel vides 75.0 mg Pack of 14’s, inspection 20’s, 28’s as report dated 9th Platelet Inhibitor per leader July 2015 & NSAID price recommended the firm for (Manufacture grant of cGMP Specification) certificate in respect of all sections. Ear/Eye Drops (General) 100. M/s Care Tobcin D Eye Form 5 FDA approved Approved Pharmaceut Drops Rs. 20,000/- Tobradex icals, 8-km, Vide Dy. No. Ophthalmic Thokar Each ml contains 2995 dated drops Raiwind i. Tobramycin 28-02-2011 manufactured Road, USP 0.3% w/v and Dy. No. by ALCON Lahore. (3 mg) 9319 dated ii. Dexamethason 30-07-2013 Tobra-D (The Schazoo e USP…0.1% Pack of 1 x Laboratories) w/v 5ml / Rs.

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(1 mg) 243.44 GMP Aminoglycoside compliance vide & corticosteroid inspection report dated 19- (USP 12-2014. Specification) 101. -do- Caresporin Ear Form 5 Health Canada Approved Drops Rs. 20,000/- approved Vide Dy. No. Polysporin ear Each ml contains 3002 dated drops (Healthy Polymixin B 28-02-2011 essential) Sulphate 10000 and Dy. No. units 9329 dated Otocain 30-07-2013 (Remington) Lignocaine HCl

50 mg Pack of 1 x 5ml / Rs. 18 GMP Peptide compliance vide antibiotics/Local inspection anesthetic report dated 19- 12-2014. (USP Specification)

Oral Dry Powder Suspension (Penicillin) 102. M/s Elite Amoxilite Oral Form 5 FDA approved Approved Pharma Suspension Rs. 20,000/- Amoxicillin (Pvt.) Ltd, Vide Dy. No. Suspension 9.5-km, Each 5 ml (after 3696 dated manufactured Sheikhupur reconstitution) 19-03-2011 by Teva Pharma a Road, contains and Dy. No. Lahore. Amoxicillin (as 876 dated 25- AMOXIL Trihydrate) … 11-2013 (GSK) 125 mg Pack of 90 ml Dedicated GMP / Rs. 50 compliant Semi Synthetic sections for Penicillin oral dry powder (Antibiotic) suspension (Penicillin) as (USP per inspection Specification) report dated 11- 09-2014

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Liquid Injection (General) 103. -do- Elikacin Injection Form 5 MHRA Deferred for clarification 250 mg Rs. 20,000/- approved regarduing Vide Dy. No. Amikacin i. Internationally, the dosage Each 2 ml Vial 882 dated 25- 250mg/ml form of amikacin is approved contains 06-2011 and (Hospira.UK) by MHRA as “Each ml of Amikacin dated 25-11- solution contains 250mg of Sulphate …. 250 2013 Grasil 250 MG / amikacin (as sulphate) ” mg 2ML (SAMI) ii. The dosage form of amikacin Pack of 2 ml / proposed by the firm i.e. 250 Aminoglycosides Rs. 100 AMKAY mg/2ml is not approved by (Antibiotic) 250MG/2ML Stringent regulatory (BP (BOSCH) authorities, however me 2 Specification) products available in local market. 104. -do- Elikacin Injection Form 5 MHRA Approved 500 mg Rs. 20,000/- approved Condition will be mentioned in Vide Dy. No. Amikacin registration letter that firm will Each 2 mlVial 877 dated 25- 500mg/ml purchase and perform installation contains 06-2011 and (Hospira.UK) and operational Amikacin (as dated 25-11- qualifications of TOC analyser and Sulphate) …. 500 2013 Grasil 500 MG / liquid particle mg 2ML (SAMI) counter in six months time. Pack of 2 ml / Aminoglycosides Rs. 160 GMP compliant (Antibiotic) sections for Liquid Injection (BP Ampoule Specification) (General) as per inspection report dated 11- 09-2014. 105. -do- Lincomin Form 5 TGA approved Approved Injection 600 mg Rs. 20,000/- Lincocin Condition will be mentioned in Vide Dy. No. 600mg/2ml vial registration letter that firm will Each 2 mL vial 875 & 1598 : Aust R 12281 purchase and perform installation contains dated 25-11- (Pfizer, New and operational lincomycin 2013 and Zealand) qualifications of TOC analyser and hydrochloride dated 04-08- liquid particle equivalent to 600 2011 Lincolide counter in six months time. mg of (Global) lincomycin. Pack of 2 ml / (Antibiotic) Rs. 40 (BP Specification)

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Liquid Injection (General) 106. M/s Surge Celine IV 0.9% Form 5 MHRA Laboratorie Injection Rs. 20,000/- approved Approved s (Private) vide Dy. No. Sodium Condition will be mentioned in Limited, Each ml contains 598 dated 21- Chloride registration letter that firm will th 10 km, Sodium Chloride 09-2011 & Solution 0.9% purchase and perform installation Faisalabad USP … 0.9% w/v 16-01-2014 w/v (Hameln and operational Road, Bikhi Pharmaceuticals qualifications of TOC analyser and District, Diluent for ) liquid particle Sheikhupur dissolving drugs Pack size of counter in six months time. a. 5ml x 100’s Soride 0.9% (USP with proposed Injection Specification) price as per (Bosch) PRC GMP compliant section vide inspection report dated 14- 04-2014. Liquid Injection general 107. M/s A-Bone Injection Form 5 MHRA Deferred for Evergreen IV ampoule/Oral Rs. 20,000/- approved One- i. Latest Inspection report. Pharmaceuti Ampoule vide Dy. No. Alpha Injection ii. Commitment as per decision of cals (Private) 170 dated 15- (Leo, UK) DRB. Limited, Plot Each ml contains 01-2011 & Dy # 590, Alfacalcidol BP No. 1789 Alfadin iii. Outline of manufacturing Sundar …. 1 mcg dated 11-10- Injection method Industrial 2012 (Danas) iv. Verification of fee for Title of Estate, Vitamins, Mineral firm has been changed to M/s Lahore. , Tonic & other Allmed. substances Pack size of Ampoule of (BP 15ml with Specification) proposed price as per brand leader Tablet (General) 108. M/s Basel Tablet X-Trin 20 Form 5 MHRA Deferred for Pharmaceut mg Rs. 20,000/- approved tablet i. Latest Inspection report icals, 227- vide Dy. No. Brexidol 20 mg required as firm has not Phase II, Each tablet 5589 dated (Cheisi) provided the inspection report. Multan contains 18-05-2011 & Industrial Piroxicam as Dy No. 572 Tablet P-cyclo ii. Commitment needs to be Estate, βcyclodextrin …. dated 12-02- 20 mg (Global) furnished as per decision of Multan. 20 mg 2014 DRB. iii. Complete outline of

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Anti Rheumatoid manufacturing method required Rs. 175 per 20 as per description of dosage (Manufacture tablets form. Specification)

109. -do- Tablet Moxyvid Form 5 FDA approved Deferred for 400 mg Rs. 20,000/- tablet Avelox i. Latest Inspection report vide Dy. No. 400 mg (Bayer) required as firm has not Each tablet 5855 dated provided the inspection report contains 18-05-2011 & Tablet FIMOX Moxifloxacin Dy No. 571 (Adamjee) ii. Commitment needs to be HCl … 400 mg dated 12-02- furnished as per decision of 2014 DRB. Antibiotic iii. The proposed description of dosage form is not as per (USP Rs. 790 per 05 innovator’s brand which is a Specification) tablets film coated tablet. iv. Firm needs to mention quantity of salt as well as base per tablet. v. The Official USP monograph of Moxifloxacin HCl requires chemical assay by HPLC method while firm has mentioned the titration method for the testing, needs clarification. 110. -do- Tablet Lee-zin 5 Form 5 MHRA Deferred for mg Rs. 20,000/- approved tablet i. Latest Inspection report vide Dy. No. Levocitrizine 5 required as firm has not Each tablet 5606 dated mg (Brwon & provided the inspection report contains 18-05-2011 & Burk, UK) Levocetrizine Dy No. 573 ii. Commitment needs to be 2HCl … 5 mg dated 12-02- Tablet Hizin furnished as per decision of 2014 (SPL) DRB. Antihistamine iii. The proposed description of dosage form is not as per (Manufacture Rs. 55 per 10 innovator’s brand which is a Specification) tablets film coated tablet.

111. -do- Tablet A-ZOLE Form 5 MHRA Deferred for 400 mg Rs. 20,000/- approved tablet i. Latest Inspection report vide Dy. No. Metronidazole required as firm has not Each tablet 5609 dated (Pharmvit) provided the inspection report contains 18-05-2011 &

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Metronidazole … Dy No. 570 Tablet flagyl ii. Commitment needs to be 400 mg dated 12-02- (sanofi) furnished as per decision of 2014 DRB. Nitroimidazole iii. The proposed description of

(USP Rs. 150 per dosage form is not as per Specification) 100 tablets innovator’s brand which is a Rs. 375 per film coated tablet. 250 tablets 112. -do- Tablet Gemiflox Form 5 FDA approved Deferred for 320 mg Rs. 20,000/- tablet Factive i. Latest Inspection report vide Dy. No. (Oscient) required as firm has not Each tablet 5884 dated provided the inspection report contains 18-05-2011 & Tablet Arja Gemifloxacin … Dy No. 569 (Unimark) ii. Commitment needs to be 320 mg dated 12-02- furnished as per decision of 2014 DRB. iii. The proposed description of Antibiotic dosage form is not as per (BP Rs. 150 per innovator’s brand which is a Specification) 100 tablets film coated tablet. Rs. 375 per 250 tablets iv. Complete description of dosage form required in terms of quantity of salt as well as base per tablet. v. Firm needs to provide photocopy of British

Pharmacopoeia as claimed for the finished product specifications.

DDC(PEC) Tablet (General)

113. M/s Shawan Bliss 4mg Tablets Form-5  Available in Approved with change Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. of brand name. Plot No. 37, Each Film coated Tablet mentioned. Road NS-1, contains: dated 30-07-2011  Risperdon of National Risperidone……4mg 8000/- 12,000/- Actavis UK. Industrial Zone Anti psychotic dated 16-08-2013 Rawat. (USP Specs) As per SRO /  Benzisox of Rawalpindi. 1x10’s Highnoon laboratories. (Routine applications)

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114. M/s Shawan Bliss 3mg Tablets Form-5  Available in Approved with change Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. of brand name. Plot No. 37, Road Each Film coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Risperdon of Industrial Zone Risperidone……3mg 8000/- 12,000/- Actavis UK. Rawat. Anti psychotic dated 16-08-2013 Rawalpindi. (USP Specs) As per SRO /  Benzisox of 1x10’s Highnoon laboratories. 115. M/s Shawan Bliss 2mg Tablets Form-5  Available in Approved with change Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. of brand name. Plot No. 37, Road Each Film coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Risperdon of Industrial Zone Risperidone……2mg 8000/- Actavis UK. Rawat. Anti psychotic 12,000/- Rawalpindi. (USP Specs) dated 16-08-2013  Benzisox of As per SRO / Highnoon 1x10’s laboratories. 116. M/s Shawan Bliss 1mg Tablets Form-5  Available in Approved with change Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. of brand name. Plot No. 37, Road Each Film coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Risperdal of Industrial Zone Risperidone……1mg 8000/- Janssen-Cilag Rawat. Anti psychotic 12,000/- Ltd. UK. Rawalpindi. (USP Specs) dated 16-08-2013 As per SRO /  Benzisox of 1x10’s Highnoon laboratories. 117. M/s Shawan Etal 200mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Quetiapine of Industrial Zone Quetiapine 200 mg (as 8000/- M/s Actvis of Rawat. fumarate) 12,000/- UK.. Rawalpindi. Hypnotic dated 04-11-2013 (Manufacturer’s Specs) As per SRO /  Evokalm of M/s 30’s Pharmevo Karachi. 118. M/s Shawan Etal 100mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film coated Tablet mentioned.  Quetiapine of NS-1, National contains: dated 30-07-2011 M/s Actvis of Industrial Zone Quetiapine 100 mg (as 8000/- UK.. Rawat. fumarate) 12,000/-  Evokalm of M/s Rawalpindi. Hypnotic dated 04-11-2013 Pharmevo (Manufacturer’s Specs) As per SRO / Karachi. 30’s 119. M/s Shawan Erbro 100mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film coated Tablet mentioned.  Topiramate of NS-1, National contains: dated 30-07-2011 M/s Sandoz

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Industrial Zone Topiramate…..100mg 8000/- UK.. Rawat. Anti Epilictic 12,000/-  Hitop of M/s Rawalpindi. (USP Specs) dated 04-11-2013 Hilton pharma As per SRO / Karachi. 30’s 120. M/s Shawan Erbro 50mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film coated Tablet mentioned.  Topiramate of NS-1, National contains: dated 30-07-2011 M/s Sandoz Industrial Zone Topiramate…..50mg 8000/- UK.. Rawat. Anti Epilictic 12,000/-  Hitop of M/s Rawalpindi. (USP Specs) dated 04-11-2013 Hilton pharma As per SRO / Karachi. 60’s 121. M/s Shawan Erbro 25mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film coated Tablet mentioned.  Topiramate of NS-1, National contains: dated 30-07-2011 M/s Sandoz UK. Industrial Zone Topiramate…..25mg 8000/-  Hitop of M/s Rawat. Anti Epilictic 12,000/- Hilton pharma Rawalpindi. (USP Specs) dated 04-11-2013 Karachi. As per SRO / 60’s 122. M/s Shawan Onze10mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Tablet contains: mentioned.  Olanzapine of NS-1, National Olanzapine…….10mg dated 30-07-2011 M/s Aurobindo Industrial Zone Antidepressant 8000/- Pharma-Mil Rawat. (USP Specs) 12,000/- Pharm Ltd. UK Rawalpindi. dated 04-11-2013  Olanzia of M/s As per SRO / Werrick 28’s Pharmaceuticals Islamabad. 123. M/s Shawan Onze5mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Tablet contains: mentioned.  Olanzapine of NS-1, National Olanzapine…….5mg dated 30-07-2011 M/s Aurobindo Industrial Zone Antidepressant 8000/- Pharma-Mil Rawat. (USP Specs) 12,000/- Pharm Ltd. UK Rawalpindi. dated 04-11-2013  Olanzia of M/s As per SRO / 7’s Werrick Pharmaceuticals Islamabad. 124. M/s Shawan Nodep 37.5mg tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film Coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Venlafaxine Industrial Zone Venlafaxine as 8000/- tablets of Rawat. HCl…..37.5mg 12,000/- Actavis, UK Rawalpindi. Antidepressant dated 04-11-2013 (USP Specs) As per SRO /  Amfax by M/s 20’s

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Amson Pharma

125. M/s Shawan Nodep 75mg tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film Coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Venlafaxine Industrial Zone Venlafaxine as HCl…..75mg 8000/- tablets of Rawat. Antidepressant 12,000/- Actavis, UK Rawalpindi. (USP Specs) dated 04-11-2013 As per SRO /  Pracit of M/s 14’s Glitz Pharma Islamabad. 126. M/s Shawan Gatin 100mg Tablet Form-5  Internationally Deferred for Pharmaceuticals, Tablet Dy. No: Not not available in confirmation of Plot No. 37, Road Each Tablet contains: mentioned. this strength in approval status by NS-1, National Gabapentin……100mg dated 30-07-2011 reference Industrial Zone Gaba analogue 8000/- authorities. 100 reference drug Rawat. (USP Specs) 12,000/- mg capsules are regulatory Rawalpindi. dated 04-11-2013 available. authorities. As per SRO /  Parketin of M/s 1x10’s Pfizer Karachi.

127. M/s Shawan Gatin 400mg Tablet Form-5  Internationally Deferred for Pharmaceuticals, Tablet Dy. No: Not not available in confirmation of Plot No. 37, Road Each Tablet contains: mentioned. this strength in approval status by NS-1, National Gabapentin……400mg dated 30-07-2011 reference Industrial Zone Gaba analogue 8000/- authorities. 100 reference drug Rawat. (USP Specs) 12,000/- mg capsules are regulatory Rawalpindi. dated 04-11-2013 available. authorities. As per SRO /  Parketin of M/s 1x10’s Pfizer Karachi.

128. M/s Shawan Gatin 300mg Tablet Form-5  Internationally Deferred for Pharmaceuticals, Tablet Dy. No: Not not available in confirmation of Plot No. 37, Road Each Film Coated Tablet mentioned. this strength in approval status by NS-1, National contains: dated 30-07-2011 reference Industrial Zone Gabapentin……300mg 8000/- authorities. 100 reference drug Rawat. Gaba analogue 12,000/- mg capsules are regulatory Rawalpindi. (USP Specs) dated 04-11-2013 available. authorities. As per SRO /  Parketin of M/s 1x10’s Pfizer Karachi.

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129. M/s Shawan Viron 15mg Tablet Form-5  Available in Approved Pharmaceuticals, Tablet Dy. No: Not MHRA, UK. Plot No. 37, Road Each Film Coated Tablet mentioned. NS-1, National contains: dated 30-07-2011  Mirtazapine Industrial Zone Mirtazapine……..15mg 8000/- tablets of Rawat. Anti Depressant 12,000/- Actavis, UK, Rawalpindi. (USP’s Specs) dated 04-11-2013 Ltd. As per SRO / 20’s  Tizapine of M/s Amarant Pharma Karachi. Evaluator I 130. M/s Saydon Busone Tablet Form 5 FDA. Buspar, 5mg Pharmaceutic 5 mg 8000 + 12000 = M/s Bristol Myers Approved al Industries Rs. 20,000/- Squibb (Pvt.) Ltd, Each Tablet vide 77/A, Contain… (Dy. No. 1113) Benzodep 5mg Hayatabad Buspirone HCl dated 23-08- tablet by M/s Zaka Industrial equivalent 2010 & dated Healthcare Estate, Buspirone 5mg 11-10-2013 Peshawar. Antidepressent As per S.R.O non- benzodiazepene

USP Specification 131. -do- Sadoquil Tablet Form 5 FDA. Seroquel 25 mg 8000 + 12000 = 25mg ( Quetiapine Approved Rs. 20,000/- (as fumarate) ) Each Film vide Roxane Coated tablet (Dy. No. 1119) contain… dated 23-08- Q-Par 25mg tablet Quetiapine (as 2010 & dated by M/s Helix fumarate) eq to 11-10-2013 Quetiapine 25mg As per S.R.O

Antipsycotic

USP Specification

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132. -do- Sayzone plus Form 5 Approved Injection -2gm 8000 + 12000 = Rs. 20,000/- Each Vial vide contains… (Dy. No. 1114) Cefoperazone dated 23-08- Sodium USP 1 2010 & dated gm and 11-10-2013 Salbactum Sodium USP 1 As per S.R.O gm.

Cephalosporin

Manufacture Specification 133. -do- Sayzone Form 5 Injection -1gm 8000 + 12000 = Actum 1gram by Approved Rs. 20,000/- M/s Standpharm Each Vial vide contains… (Dy. No. 1114) Cefoperazone dated 23-08- Sodium USP 2010 & dated 500mg and 11-10-2013 Salbactum Sodium USP As per S.R.O 500mg.

Cephalosporin

Manufacture Specification 134. -do- Zoleft Tablet Form 5 FDA. Tablet Zoloft 100mg 8000 + 12000 = 100mg ( Sertraline Approved Rs. 20,000/- as HCl eq. to Each tablet vide Sertraline) contains (Dy. No. 1108) Sertraline as dated 23-08- Ertaline 100mg HCl eq. to 2010 & dated tablet by M/s Sertraline 11-10-2013 Genome ….100mg. As per S.R.O Antidepressant

B.P Specification

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135. -do- Celecob Form 5 FDA. Capsule Capsule 200mg 8000 + 12000 = Celebrex 200mg Approved Rs. 20,000/- (celecoxib) Each capsule vide contains (Dy. No. 1105) Celicob 200mg celecoxib dated 23-08- capsule by M/s ….200mg. 2010 & dated Votex 11-10-2013 NSAID As per S.R.O Manufacturer’s Specification 136. -do- Sadoquil Tablet Form 5 FDA. Seroquel 100mg 8000 + 12000 = 100mg (Quetiapine Approved Rs. 20,000/- (as fumarate ) Each Film vide Roxane Coated tablet (Dy. No. 1120) contains… dated 24-08- Q-Par 100mg tablet Quetiapine (as 2010 & dated by M/s Helix fumarate) eq to 11-10-2013 Quetiapine 100mg As per S.R.O

Antipsycotic

Manufacturer’s Specification 137. -do- Zoleft Tablet Form 5 FDA. Tablet Zoloft 25mg 8000 + 12000 = 25mg ( Sertraline as Approved with change in Rs. 20,000/- HCl eq. to brand name Each tablet vide Sertraline) contains (Dy. No. ------) Sertraline as dated 23-08- Lowtral 25mg tablet HCl eq. to 2010 & dated by M/s Lowitt Sertraline 11-10-2013 ….25mg. As per S.R.O Antidepressant

B.P Specification

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138. -do- Hapirol Form 5 MHRA Haloperidol Injection 5mg 8000 + 12000 = Injection BP 5mg/ml Approved Rs. 20,000/- by M/s Amdipharm Each 1ml vide Condition will be mentioned in ampoule (Dy. No. 1116) Dosik 5mg tablet by registration letter that firm will contains dated 23-08- M/s Adamjee purchase and perform Haloperidol as 2010 & dated installation and operational Decanoate eq. 11-10-2013 qualifications of TOC analyser to Haloperidol and liquid particle ….5mg. As per S.R.O counter in six months time.

(Butyrophenone )

B.P Specification 139. -do- Nupain Form 5 FDA Nalbuphine Injection 10mg 8000 + 12000 = HCl 10mg/ml Approved Rs. 20,000/- Each 1ml vide Aknal 10mg Condition will be mentioned in ampoule (Dy. No. ……) Injection by M/s registration letter that firm will contains dated 23-08- Akhai purchase and perform Nalbuphine 2010 & dated installation and operational HCl ….10mg. 11-10-2013 qualifications of TOC analyser and liquid particle (Narcotic As per S.R.O counter in six months time. Analgesic)

Manufacturer’s Specification 140. -do- Nupain Form 5 FDA Nalbuphine Injection 20mg 8000 + 12000 = HCl 20mg/ml Approved Rs. 20,000/- Each 1ml vide Aknal 20mg Condition will be mentioned in ampoule (Dy. No.1106) Injection by M/s registration letter that firm will contains dated 23-08- Akhai purchase and perform Nalbuphine 2010 & dated installation and operational HCl ….20mg. 11-10-2013 qualifications of TOC analyser and liquid particle (Narcotic As per S.R.O counter in six months time. Analgesic)

Manufacturer’s Specification

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Evaluator I Injection Psychotropic

141. M/s Roryan Lorazep 1mg Form 5 FDA: ATIVAN Pharmaceut Tablet 23-04-2015 1mg (Lorazepam) Approved ical Each Tablet Rs. 20,000/- ATIVAN 1mg Industries Contains:- (Dy. No. (Lorazepam) Reg PVT Lorazepam 1094) No. 000083 Limited, (B.P)…1mg (F.16-4/2013- PFIZERPHARMA Industrial (Benzodiazepine Reg-IV dated Grant of Estate Tranquilizer) 10-04-15 additional section Hayatabad, (B.P. &23-04-15) psychotropic Peshawar Specification As Per SRO / (Tablet) Psychotropi 10 recommended.(26 c x10’s -01-2011) (Tablet) C GMP Latest Section Inspection Report No. F.3- Held on 11-12- 3/2001- 2014 Lic dated By FDI Peshawar 26-01- The firm has 2011) installed Potentiometer as also confirmed by the area FID with following remarks vide inspection dated 30-07-2015 “ Recently they have purchased new titration series with the name of titro cam 7000 (potentiometer) from Germany as per the direction of the Registration Board in its 249th meeting. The firm has installed this machine calibrated and validate.

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142. -do- Lorazep 2mg Form 5 FDA: ATIVAN Tablet 23-04-2015 2mg (Lorazepam) Approved Each Tablet Rs. 20,000/- ATIVAN 2mg Contains:- (Dy. No. (Lorazepam) Reg Lorazepam 1098) No. 001284 (B.P)…2mg (F.16-4/2013- PFIZER (Benzodiazepine Reg-IV dated PHARMA PVT Tranquilizer) 10-04-15 LTD PAKISTAN (B.P. &23- Grant of Specification) 04-15) additional section As Per SRO / psychotropic 10 (Tablet) x 10’s recommended.(26 -01-2011) GMP Latest Inspection Report Held on 11-12- 2014 By FDI Peshawar 143. -do- DIZEP 5mg Form 5 (Diazepam) Tablet 23-04-2015 VALIUM 5mg Approved Each Tablet (1096) (Dizepam) Reg Contains:- Rs. 20,000/- No. 003066 Diazepam As Per SRO / MARTIN DOW (B.P)…5mg 3 PHARMA (Benzodiazepine x 10’s KARACHI Tranquilizer) As Per SRO (B.P. /1000 x Jar Specification) 144. -do- DIZEP 10mg Form 5 BNF: 10 mg Tablet 23-04- (Diazepam) Approved Each Tablet 2015(1097) VALIUM 10mg Contains:- Rs. 20,000/- (Dizepam) Reg Dizepam As Per SRO / No. 003480 (B.P)…10mg 3 MARTIN DOW (Benzodiazepine x 10’s PHARMA Tranquilizer) As Per SRO / KARACHI (B.P. 1000 x Jar PAKISTAN Specification)

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145. -do- PHENOBAR Form 5 BNF: 30mg 23-04-2015 (Phenobarbital Approved Tablet (1093) Tablets) Each Tablet Rs. 20,000/- Phenotab 30mg Contains:- As Per SRO / (Phenobarbitone) Phenobarbitone 3 Reg No. 016020 (B.P)…30mg x 10’s WILSHIRE (Barbiturate) As Per SRO / PHARMA (B.P. 1000 x Jar LAHORE Specification) PAKISTAN 146. -do- RONAX 1mg Form 5 FDA: XANAX Tablet 09-04- 1mg Approved Each Tablet 2015(183) (Alprazolam) Contains:- Rs. 20,000/- XANAX 1mg Alprazolam As Per SRO / (Alprazolam) Reg (B.P)…1mg 3 No. 013349 (Benzodiazepine x 10’s PFIZER Tranquilizer) PHARMA (B.P. KARACHI Specification) PAKISTAN 147. -do- RONAX 0.5mg Form 5 FDA: XANAX Tablet 09-04- 0.5mg Approved Each Tablet 2015(184) (Alprazolam) Contains:- Rs. 12,000/- XANAX 0.5mg Alprazolam 19-07-2010 (Alprazolam) Reg (B.P)…0.5mg Rs. 8,000/- No. 012303 (Benzodiazepine As Per SRO / PFIZER Tranquilizer) 3x 10’s PHARMA (B.P. KARACHI Specification) PAKISTAN 148. -do- DEPNIL 3mg Form 5 Lexotan (TGA) Tablet 09-04- LAXOTANIL Approved Each Tablet 2015(186) 3mg Contains:- Rs. 12,000/- (Bromazepam) Bromazepam 19-07-2010 Reg No. 001043 (B.P)…3mg Rs. 8,000/- MARTIN DOW (Benzodiazepine As Per SRO / PHARMA Tranquilizer) 3 KARACHI (B.P. x 10’s PAKISTAN Specification)

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Evaluator I Capsule General 149. M/s Carveda XR Form-5 Not confirmed Deferred for Ferozsons 40mg Capsule 21-06-2011 Carved capsule by  Commitments as per decision Laboratorie Each capsule diary No 220. M/s Amsons require of board are required. s Limited, contains:- Rs15000 to be verified  International availability is P.O Carvedilol &85000 dated Fresh inspection not provided by the firm. Ferozsons, Phosphate SR 25-02-2014 report is required as  Legalized GMP and stability Amangarh, pellets eq. to Rs.40 per attached is 31-12- data is required for source of Nowshera, Carvedilol 40mg. capsule 2009. pellets. KPK Beta-adrenergic  Finish product specifications blocking drug are incomplete require to be Manufacturer’s submitted. Specifications  Fresh inspection report is Source of required. pellets:- M/s RA Chem Pharma Ltd, Plot # A- 19/C, Road No. 18, IDA, Nacharam, India.

150. -do- Carveda XR Form-5 Not confirmed Deferred for 80mg Capsule 21-06-2011 Carved capsule by  Commitments as per decision Each capsule diary No 219. M/s Amsons require of board are required. contains:- Rs15000 & to be verified  International availability is Carvedilol 85000 dated Fresh inspection not provided by the firm. Phosphate SR 25-02-2014 report is required as  Legalized GMP and stability pellets eq. to Rs.79 per attached is 31-12- data is required for source of Carvedilol 80mg. capsule 2009. pellets. Beta-adrenergic  Finish product specifications blocking drug are incomplete require to be Manufacturer’s submitted. Specifications  Fresh inspection report is Source of required. pellets:- M/s RA Chem Pharma Ltd, Plot # A- 19/C, Road No. 18, IDA, Nacharam, India.

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151. -do- Carveda XR Form-5 Not confirmed Deferred for 20mg Capsule 21-06-2011 Carved capsule by  Commitments as per Each capsule diary No 222. M/s Amsons require decision of board are contains:- Rs15000 & to be verified required. Carvedilol 85000 dated Fresh inspection  International availability is Phosphate SR 25-02-2014 report is required as not provided by the firm. pellets eq. to Rs.79 per attached is 31-12-  Legalized GMP and stability Carvedilol 20mg. capsule 2009. data is required for source of Beta-adrenergic pellets. blocking drug  Finish product Manufacturer’s specifications are Specifications incomplete require to be Source of submitted. pellets:- M/s RA  Fresh inspection report is Chem Pharma required. Ltd, Plot # A- 19/C, Road No. 18, IDA, Nacharam, India.

152. -do- Carveda XR Form-5 Not confirmed Deferred for 10mg Capsule 21-06-2011 Carved capsule by  Commitments as per decision Each capsule diary No 221. M/s Amsons require of board are required. contains:- Rs15000 & to be verified  International availability is Carvedilol 85000 dated Fresh inspection not provided by the firm. Phosphate SR 25-02-2014 report is required as  Legalized GMP and stability pellets eq. to Rs.79 per attached is 31-12- data is required for source of Carvedilol 10mg. capsule 2009. pellets. Beta-adrenergic  Finish product specifications blocking drug are incomplete require to be Manufacturer’s submitted. Specifications  Fresh inspection report is Source of required. pellets:- M/s RA Chem Pharma Ltd, Plot # A- 19/C, Road No. 18, IDA, Nacharam, India.

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Evaluator I Tablet General 153. -do- Exemet 2/1000 Form-5 Not confirmed Deferred for SR Tablet 29-06-2011 Getformin tablet by  Commitments as per decision Each tablet diary No 306. M/s Getz Pharma of board are required. contains:- Rs8000 & require to be verified  International availability is Glimepiride as 12000 dated as already registered not provided by the firm. immediate release 25-02-2014 is 2/500mg  Finish product specifications layer…2mg Rs.9.50 per Fresh inspection are incomplete require to be Metformin HCl as tablet report is required as submitted. sustained release attached is 31-12-  Fresh inspection report is layer…1000mg. 2009. required. Antihyperglycemi  Double layer tablet machine c agent require to be verified. Manufacturer’s Specifications 154. -do- Exemet 1/1000 Form-5 Not confirmed Deferred for SR Tablet 29-06-2011 Getformin tablet by  Commitments as per Each tablet diary No 307. M/s Getz Pharma decision of board are contains:- Rs8000 & require to be verified required. Glimepiride as 12000 dated as already registered  International availability is immediate release 25-02-2014 is 1/500mg not provided by the firm. layer…1mg Rs.7.90 per Fresh inspection  Finish product Metformin HCl as tablet report is required as specifications are sustained release attached is 31-12- incomplete require to be layer…1000mg. 2009. submitted. Antihyperglycemi  Fresh inspection report is c agent required. Manufacturer’s  Double layer tablet machine Specifications require to be verified.

155. -do- Mezacol 400 Form-5 Not confirmed Deferred for Tablet 12-05-2011 Asacol tablet by M/s  Commitments as per decision Each tablet diary No 20. Getz Pharma. of board are required. contains:- Rs8000 & Fresh inspection  International availability is Mesalazine…400 12000 dated report is required as not provided by the firm. mg. 25-02-2014 attached is 31-12-  Finish product specifications Anti- Rs.380.00 per 2009. are incomplete require to be inflammatory 30’s tablet submitted. Manufacturer’s pack.  Fresh inspection report is Specifications required.

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156. -do- Trinide 500mg Form-5 Not confirmed Deferred for Tablet 17-11-2011 Nitazide tablet by  Commitments as per decision Each film coated diary No 272. M/s Helix Pharma. of board are required. tablet contains:- Rs8000 & Fresh inspection  International availability is Nitazoxanide…50 12000 dated report is required as not provided by the firm. 0mg. 25-02-2014 attached is 31-12-  Finish product specifications Anti-protozoal Rs.25 per 2009. are incomplete require to be Manufacturer’s tablet. submitted. Specifications  Fresh inspection report is required.

Evaluator I (Cephalosporin Injection)

157. M/s Astellas Cephlex 125 dry Form-5 Not confirmed Deferred for Pharmaceuti Suspension 20-05-2011 Davox by M/s Fynk  Commitments as per decision cal (Pvt) Ltd Each 5ml diary No 48. Pharma. of board are required. 15-C contains Rs8000 & Fresh inspection  Finish product specifications Industrial Cefadroxil 12000 dated report is required. are incomplete require to be Estate Monohydrate 11-02-2014 submitted. Hayatabad, eq.to As per SRO.  Fresh inspection report is Peshwar. Cefadroxil…..125 required. mg.  Approval of section is Cephalosporin required. USP Specifications 158. -do- Cephlex 250 dry Form-5 Not confirmed Deferred for Suspension 20-05-2011 Davox by M/s Fynk  Commitments as per Each 5ml diary No 119. Pharma. decision of board are contains Rs8000 & Fresh inspection required. Cefadroxil 12000 dated report is required.  Finish product Monohydrate 11-02-2014 specifications are eq.to As per SRO. incomplete require to be Cefadroxil…..250 submitted. mg.  Fresh inspection report is Cephalosporin required. USP  Approval of section is Specifications required.

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159. -do- Astaclor 50mg Form-5 Not confirmed Deferred for drops 24-03-2011 Ceclor by M/s AGP  Commitments as per decision Each ml contains diary No 73. Pharma. of board are required. Cefaclor Rs8000 & Fresh inspection  Finish product specifications Monohydrate 12000 dated report is required. are incomplete require to be eq.to 11-02-2014 submitted. Cefaclorl…..50m As per SRO.  Fresh inspection report is g. required. Cephalosporin  Approval of section is USP required. Specifications 160. M/s Care Occubetan Eye Form-5 Require to be Deferred for Pharmaceuti Drops Dy No. 7444 verified  Finished product cals, 8-KM, Each ml dated 20-07- specifications are incomplete, Thokar contains:- 2012 Rs.8000 Betatek-N Drops by require to be submitted. Raiwind Neomycin & Rs.12,000 M/s Innvotek  The firm has not submitted Road, Sulphate...0.5%w/ dated 30-07- Pharma the method of sterilization Lahore. v Betamethasone 2013 for eye drops which require Sodium Rs.50/7.5ml to be clarified. Phosphate….0.1 bottle.  The date of submission %w/v require to be verified as per Antibiotic, policy. Corticosteride  Commitment as approved by Incomplete the Registration Board Specifications. require to be submitted.  Fresh inspection report is required.

161. -do- Zincar Syrup Form-5 Require to be Deferred for Each 5ml Dy No. 1063 verified  The calculations are require contains:- dated 24-05- Diazinc syrup by to be submitted in salt form elemental Zinc 2011 Rs.8000 M/s searle as per specifications. ...20mg & Rs.12,000  The firm has attached the Not provided dated 30-07- photocopy of the fee Incomplete 2013 submission require to be Specifications. Rs.80/60ml verified. bottle.  Commitment as approved by the Registration Board require to be submitted.  Fresh inspection report is required.

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162. -do- Neobat Cream Form-5 Betnovate N cream Deferred for Each gram Dy No. 1061  The calculations are require contains:- dated 24-05- Betnovate N cream to be submitted in salt form Betamethasone 2011 Rs.8000 as per specifications. Valerate ....0.1% & Rs.12,000  In the finished product Neomycin dated 30-07- specifications only assay is Sulphate….0.5% 2013 given without any reference. Corticosteride, Rs.30/10gm  Raw material specifications antibiotic pack. are not given. Incomplete  Commitment as approved by Specifications. the Registration Board require to be submitted.  Fresh inspection report is required.

163. -do- Neobat Ointment Form-5 Deferred for Each gram Dy No. 299 Betnovate N  The calculations are require contains:- dated 15-09- Ointment by M/s to be submitted in salt form Betamethasone 2011 Rs.8000 GSK as per specifications. Valerate ....0.1% & Rs.12,000  In the finished product Neomycin dated 30-07- specifications only assay is Sulphate….0.5% 2013 given without any reference. Corticosteride, Rs.30/10gm  Raw material specifications antibiotic pack. are not given. Incomplete  Commitment as approved Specifications. by the Registration Board require to be submitted.  Fresh inspection report is required.

164. -do- Optilone Eye Form-5 Require to be Deferred for Drops Dy No. 7447 verified  Finished product Each ml dated 20-07- Solopred drops by specifications are contains:- 2012 Rs.8000 M/s Jeans incomplete, require to be Prednisolone USP & Rs.12,000 submitted. ....0.1% dated 30-07-  The firm has not submitted Corticosteride, 2013 the method of sterilization Incomplete Rs.30/10gm for eye drops which require Specifications. pack. to be clarified.  The date of submission require to be verified as per policy.  Commitment as approved by the Registration Board require to be submitted.  Fresh inspection report is required.

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 The firm has submitted in manufacturing method that they are using distilled water for solution preparation, while in the dossier they have not mentioned the facility.

165. M/s Irza Jaldin Injection Form 5 Firm has provided Deferred for Pharma (Pvt) Each ml injection Dy No.619 the international as  Finish product specification Ltd, 10.2 contains:- Rs.8000 dated feldene injection, are incomplete, only assay is K.M, Piroxicam….20m 28-05-2011 & however it can’t be given. Sheikhupura g Rs. 12,000 verified from FDA  Raw material specifications Road, Oxicam dated 29-07- where it is present in are not provided. Lahore Require to be 2013. only capsule form.  International availability provided. As per SRO Aksocam injection provided by the firm but by M/s Akson product does not exist in Pharma FDA.  Fresh inspection report.  Outline of manufacturing method is not provided.  In the list of equipments firm has mentioned vial dosing machine and other irrelevant equipments, which requires clarification.  Sterilization of the product is not mentioned by the firm. 166. -do- Meronide Form 5 Flagyl Deferred for Infusion Dy No.4830 Klint Infusion by  The product is in the form Each 100ml Rs.8000 dated M/s Sami Pharma of metronidazole in plastic infusion 28-04-2011 & bags, however in vials form contains:- Rs. 12,000 the product is in salt form as Metronidazole… dated 29-07- checked from MHRA & …500mg 2013. FDA official sites. Nitromidazole As per SRO  The firm has applied the Require to be product as Metronidazole provided. and WFI to make the volume, no other ingredient has been added in the formulation , which requires clarification.  Outline of manufacturing method has not been provided by the firm.

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167. M/s Lexxel Tablet Form 5 MHRA Cipralex Deferred for Pharmacare Each tablet Dy No.1166 20mg f/c tablet  Raw material and finished Labs (Pvt) contains:- Rs.8000 dated Cipralex 20mg by product specifications need Ltd, 129/1, Escitalopram 28-12-2011 & M/s Lundbeck to be submitted. Industrial Oxalate eq.to Rs. 12,000  Outline of manufacturing Estate, Escitalopram dated 31-07- method needs to be provided. Kotlakhpat, 20mg 2013.  Description of the dosage Lahore. Anti-depressant As per SRO form is not provided. Needs to be  Fresh inspection require to be provided submitted.

Evaluator IV Tablet (General) Section

168. M/s Tablet Winzyme Form 5 ------Deferred for confirmation of WnsFeild Rs. 20,000/- -- approval status by reference Pharmaceut Each tablet vide Dy. No. regulatory authorities icals, Plot # contains 2504 dated Copil Enzyme 122, Block Metoclopramide 06-11-2012 is Tablet (Wilson) A, Phase V, (as now on Industrial monohydrochlori priority at GMP compliant Estate, place of section vide de monohydrate) Hattar application inspection 6 mg dated 15-11- report dated 02- Simethicone 50 2012. 04-2015. mg Pancreatin 210 Pack of P.U 10’s tablets Bromelains Alu/Alu Blister as per 35000 P.U SRO

NSAID/Analgesic

(Manufacture Specification) 169. -do- Tablet Form 5 EMA approved Lornoxicam 8 mg Rs. 20,000/- Nycomed 8mg Approved vide Dy. No. tablet Each film coated 2506 dated (Denmark) tablet contains 06-11-2012 Lornoxicam 8mg now on Zafon Tablet priority at (Getz) NSAID/Analgesic place of (Manufacture application GMP compliant Specification) dated 15-11- section vide 2012. inspection

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Pack of report dated 02- Alu/Alu 04-2015. Blister as per SRO

Liquid Injection (General) 170. -do- Moflex Form 5 Avelox (FDA) 400mg/100ml Rs. 20,000/- Approved infusion vide Dy. No. Moxan 2982 dated (Hygiea) Condition will be mentioned in Each 100ml vial 25-10-2013 registration letter that firm will contains GMP compliant purchase and perform installation Moxifloxacin as now on section vide and operational HCl 400mg priority at inspection qualifications of TOC analyser and place of report dated 02- liquid particle Antibiotics application 04-2015. counter in six months time. (Manufacture dated 15-11- Specification) 2012. Pack of 100ml as per SRO

EVALUATOR II

171. Remington Cokiren 150/25 Form 5 Co-Alis 150/25 Deferred for: Pharmaceutical Tablet 30-11-2010 Hilton Pharma.  Commitment Industries Each Film coated tablet contains:- Rs.8000/- USFDA as per 251st (Pvt) Ltd. Aliskiren hemifumrate eq to 30-07-2013 meeting. aliskiren…….150mg Rs.12,000/-  Latest Hydrochlorthiazide USP….25mg 2x10’s/ inspection (Renin Inhibitor and Diuretic) Leader Prices report.

172. Remington Valpin 10/160 Form 5 Extor 10/160 Deferred for: Pharmaceutical Tablet 28-01-2011 Searle  Commitment Industries Each Film coated tablet contains:- Rs.8000/- USFDA as per 251st (Pvt) Ltd. Amlodipine (as besylate)….10mg 30-07-2013 meeting. Valsartan……………………160mg Rs.12,000/-  Latest (Calcium channel blocker & 14’s, 28’s/ inspection angiotensin-II receptor antagonist) Leader Prices report.

173. Genera Zegen Dispersible Tablets Form 5 Melbek Deferred for Pharmaceutical Tablet Dy No. 5601 Navegal  Clarification Islamabad. Each tablet contains:- 23-05-2011 Laboratories of licence Elemental zinc as zinc sulphate Rs.8000/- from CLB.

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monohydrate USP……..20mg 16-07-2013  Last (Antiseptic / sympathomimetic) Rs.12,000/- inspection 10’s/ As per report. PRC  Label claim and Me too confirmation.  Calculation on the basis of salt.  Firm has provided 6 month stability studies. ADC invoice not provided to check genuinity of studies.  In master formulation calculation on the basis of salt.  Claim was dispersible tablets but in specification it is coated tablet.  Commitment as per Board’s approval in 251st meeting. 174. -do- Gentil Form 5 Atrotil Deferred for Tablet Dy No. 5602 Akson  Clarification Each tablet contains:- 23-05-2011 Discontinued in of status of Diphenoxylate HCl……..2.5mg Rs.8000/- FDA licence from Atropine Sulphate……25mcg 16-07-2013 Registered in CLB. (Antidiarrhoeal) Rs.12,000/- MHRA  Last 5ox10’s, inspection 10x10’s report. As per PRC  Label claim.  Firm has provided 6 month stability studies. ADC

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invoice required to check genuinity of studies.  Commitment as per Board’s approval in 251st meeting. 175. -do- Gentamol 500mg Form 5 Onidol Deferred for Tablet Dy No. 3039 Heller  Clarification Each tablet contains:- 29-06-2011 of status of Paracetamol……..500mg Rs.8000/- licence from Chlorpheniramine 16-07-2013 CLB. Maleate……..……..2mg Rs.12,000/-  Last Caffeine…………..65mg 10’s/ As per inspection (Analgesic) PRC report.

 Label claim and Me too confirmation.  Calculation on the basis of salt.  Firm has provided 6 month stability studies. ADC invoice not provided to check genuinity of studies.  In master formulation calculation on the basis of salt.  Claim was dispersible tablets but in specification it is coated tablet.  Commitment as per Board’s approval in 251st meeting.

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176. -do- Amoxygen Dispersable Tablets Form 5 Amoxillin Deferred for Tablet Dy No. 5605 Ideal  Clarification Each tablet contains:- 23-05-2011 of status of Amoxycillin trihydrate eq to Rs.8000/- Licence from amoxicillin base……..500mg 16-07-2013 CLB (Broad Spectrum Penicillin) Rs.12,000/-  Last 10’s/ As per inspection PRC report.

 Label claim & Me too confirmation.  ADC invoice to verify stability studies.  Commitment as per Board’s approval in 251st meeting. 177. -do- Amoxygen Dispersable Tablets Form 5 Amoxillin Deferred for Tablet Dy No. 5604 Ideal  Clarification Each tablet contains:- 23-05-2011 of status of Amoxycillin trihydrate eq to Rs.8000/- Licence from amoxicillin base……..250mg 16-07-2013 CLB. (Broad Spectrum Penicillin) Rs.12,000/-  & Last 10’s/ As per inspection PRCS report.  ADC invoice to verify stability studies.  Commitment as per Board’s approval in 251st meeting not provided. 178. -do- Ethro Form 5 Novomycin Deferred for Powder for Oral Suspension Dy No. 5603 Krka-Pak  Clarification Each 5ml contains:- 23-05-2011 Pharmaceutical of Licence Erythromycin Ethyl Succinate USP Rs.8000/- & Chemical from CLB. eq to Erythromycin ……..200mg 16-07-2013 Works.  Last (Antibiotic/ Macrolide) Rs.12,000/- inspection 60ml report. As per PRC  ADC invoice

to verify stability studies.

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 Commitment as per Board’s approval in 251st meeting. 179. -do- Genicol Form 5 Acepol Deferred for Suspension Dy No. 3040 Hassan  Clarification Each 5ml contains:- 29-06-2011 of Licence Paracetamol……..120mg Rs.8000/- from CLB. (Analgesic) 16-07-2013  Last Rs.12,000/- inspection 60ml report. As per PRC  ADC invoice

to verify stability studies.  Commitment as per Board’s approval in 251st meeting. 180. -do- Osmoless-M Form 5 Pedialyte Deferred for Sachet Dy No. 3038 Abbott  Clarification Each contains:- 29-06-2011 of Licence Sodium Cloride……..0.52gm Rs.8000/- from CLB. Potassium Chloride…0.30gm 16-07-2013  Last Trisodium citrate Rs.12,000/- inspection Dihydrate…0.58gm 60ml report. As per PRC Glucose Anhydrous B.P…2.7gm  ADC invoice

(Antidiarrhoeal) to verify stability studies.  Commitment as per Board’s approval in 251st meeting.

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b) Grant of registration for Imported Finished Drugs (Routine).

EVALUATOR III

S/N Name and Brand Name Type of International Remarks address of Form status in manufacturer (Proprietary name reference drug / Applicant + Dosage Form + Initial date, agencies / Strength) diary authorities Composition Fee Me-too status Pharmacological including Group differential GMP status as fee depicted in Finished product latest inspection Specification Demanded report (with Price / date) by the Pack size Evaluator 181. M/s Martin BON-ONE Tablets Form-5A As per COPP Approved subject Dow product is to compliance of Pharmaceutical Each tablet Dy No. 195 available in Import Policy for s, Plot No. 37 contains: dated 20-03- Japan which is Finished Drugs and sector 19, Alfacalcidol……0. 2011 one of reference confirmation of Korangi 25mcg authority of storage facility of Industrial 15000/- DRAP. importer. Area, Karachi Anti Osteoporotic dated 28-03- agent 2011 Adela of Getz M/s Teijin 35000/ Pharma, Karachi Pharma Manufacturer dated 29-05- Limited, 13, 50000/- Iwakuni dated 11-09- Pharmaceutical 13 Factory, 2-1 Kasumigaseki, 144.60/ 3-chome, 10’s, Chiyoda-ku, 289.20/ Tokyo Japan 20’s, (2-1, Hinedo- 433.80/ 30’s cho, Iwakuni, & 578.40/ Yamaguchi) 40’s 182. -do- BON-ONE Tablets Form-5A As per COPP Approved subject product is to compliance of Each tablet Dy No. 194 available in Import Policy for contains: dated 20-03- Japan which is Finished Drugs and Alfacalcidol……1 2011 one of reference confirmation of mcg authority of storage facility of 15000/- DRAP. importer. Anti Osteoporotic dated 28-03-

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agent 2011 Adela of Getz 35000/ Pharma, Karachi Manufacturer dated 29-05- 13, 50000/- dated 11-09- 13

471.25/ 10’s, 942.50/ 20’s, 1413.70/ 30’s & 1885.00/ 40’s 183. M/s Allmed MONOFER Form-5A MHRA Deferred for: Laboratories, 100mg/ml Solution approved.  Submission of A-21/3, KDA for Injection/ Dy No: 145 Monofer of complete fee as Scheme 1, Infusion (5ml) dated 29-11- Pharmacosmos, manufacturer Karachi 10 UK. abroad has Each ml contains: changed their M/s Iron as Iron (III) 15000 dated Monofer of agent. Pharmacosmos Isomaltoside 29-11-10 Allmed.  Valid sole A/s 1000…..100mg 85000/- agency Roervangsevj dated 11-10- agreement as 30 DK-4300 Iron parenteral 12 earlier Holbaek, preparation agreement has Denmark Rs 5396/- expired. Manufacturer Ampoule of  Legalized 5ml COPP of the product.  Stability data as per WHO/ICH conditions

184. M/s Allmed MONOFER Form-5A MHRA Deferred for: Laboratories, 100mg/ml Solution approved.  Submission of A-21/3, KDA for Injection/ Dy No: 176 Monofer of complete fee as Scheme 1, Infusion (10ml) dated 29-11- Pharmacosmos, manufacturer Karachi 10 UK. abroad has Each ml contains: changed their M/s Iron as Iron (III) 15000 dated Monofer of agent. Pharmacosmos Isomaltoside 29-11-10 Allmed.  Valid sole A/s 1000…..100mg 85000/- agency Roervangsevj dated 25-07- agreement as

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30 DK-4300 Iron parenteral 13 earlier Holbaek, preparation agreement has Denmark Rs 10192/- expired. Manufacturer Ampoule of  Legalized 10ml COPP of the product.  Stability data as per WHO/ICH conditions.

185. M/s Allmed METOGEN Form-5A Int. availability Deferred for: Laboratories, Injection 0.25g not confirmed.  Confirmation of A-21/3, KDA Dy No: 102 availability in Scheme 1, Each vial contains: dated 10-08- Ganvir of reference Karachi Ganciclovir……0.2 09 Mission Pharma. authorities. 5g  Sole agency M/s Beijing SL 15000 dated agreement. Pharmaceutical Antiviral ( 10-08-09  Legalized valid Co. Ltd, No.9, Synthetic guanine 85000/- COPP. Zhongyuan derivative against dated 11-10-  Stability data as Road, Badachu viruses) 12 per WHO/ICH High Tech conditions. Park Beijng, USP/ CP Rs 22000/- P.R.China. Pack of 10vials. 186. M/s B. Braun Emulsion for Form 5A As per COPP Deferred for Pakistan (Pvt) Infusion product is accelerated and real Limited, The Dy. No: 755 available in time stability data Forum Suite Each 1000ml dated 06-07- Germany which as per ICH/WHO 216, contains: 12 is one of the Zone IV-A Khayaban-e- Medium chain reference drug conditions and Jami, Clifton triglycerides…..100 15000/- authority. confirmation of me Block -9 g dated 06-07- too status Karachi Soya bean oil, 12 Me-too not refined……80g confirmed M/s B. Braun Omega-3-acid Rs. 1120/- Melsungen triglycerides……20 Pack of 1’s AG, Carl – g (250ml Braun-Str.134 glass bottle) 212 Solution for Melsungen, parenterals Germany. nutrition, fat emulsion

Manufacturer

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187. M/s B. Braun ONDANSETRON Form 5A MHRA Deferred for Pakistan (Pvt) B. Braun 2mg/ml approved. clarification Limited, The (Solution for Dy. No: 446 Ondansetron regarding statement Forum Suite injection/infusion) dated 26-12- Accord that firm cannot 216, 13 Healthcare UK. mention Khayaban-e- Each ml contains: manufacture date Jami, Clifton Ondansetron 100000/- Zofran of GSK on primary Block -9 Hydrochloride eq. dated 26-12- Karachi. pakaging. Karachi to 13 Ondansetron…….. M/s B. Braun 2mg Rs. 905/- Melsungen Pack of 1’s AG, Carl – Antiemetic, anti (4ml plastic Braun-Str.134 nauseant, Serotonin ampoule) 212 5HT3 antagonist Melsungen, Germany. BP 188. Importer KETOFAST Form-5A International Deferred for: M/s Efroz Cataplasma availibility not  Evidence of Chemical Dy No : 468 confirmed. approval of Industries (Pvt) Each sheet dated 26-01- same dosage Limited, 12-C (9x13cm2, 11.7gm) 11 Me-too status form, generic Block 6, contains: 15000/- not confirmed. and strength in P.E.C.H.S. off Ketoprofen…..25.0 dated 26-01- reference drug Shahrah-e- 7mg 11 agency. Faisal, Karachi 85000/-  Confirmation of Manufacturer NSAID dated 19-02- address of the M/s Dae Hwa 14 manufacturer of Pharmaceutical Manufacturer the applied s Co., Ltd Rs. 500/- product as the 495- Hanu-ro-, Per 6’s address Hoenseong- Sheets mentioned on eup, Form-5A & Hoenseong, GMP is different Gangwon-do, from the address Republic of mentioned in the Korea. COPP. Moreover, address of manufacturer on sole agency agreement is different from address of above mentioned documents.  Clarfication that

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applied drug is generic product hence clinical data and clinical justification is not required.  Stability data as per WHO/ICH Zone-IV A. 189. M/s Fabnos Lidocaine 2% E80 Form-5A Deferred for: International International  Submission of 26-C, Tauheed Each dental Dy No :27 availability not Legalized commercial cartridge of 1.8ml dated 11-12- confirmed. COPP. area, street No. contains: 2007  Confirmation of 26 Phase V, Lidocaine 15000/- Me-too status availability in DHA Karachi Base……36mg dated 10-12- not confirmed reference drug Epinephrine….0.02 2007 authorities. M/s News 25mg 85000/- Legalized COPP  Confirmation of Stetic S.A, dated 30-04- need to be me-too status. Careera 53N Anesthetic 14 submitted, Firm  Stability studies 50-09, has submitted as per Autipista Manufacturer 14$ per copy of COPP. ICH/WHO Medillin cartridge/ Zone IV-A. Bagota Km, 22 Glass Guarne P.O. cartridge of Box 1759 1.8ml Antiquia, Medellin, Columbia. 190. M/s Fabnos Lidocaine 2% Form-5A Deferred for: International International  Submission of 26-C, Tauheed Each dental Dy No :26 availability not Legalized commercial cartridge of 1.8ml dated 11-12- confirmed. COPP. area, street No. contains: 2007  Confirmation of 26 Phase V, Lidocaine 15000/- Me-too status availability in DHA Karachi Base……36mg dated 10-12- not confirmed reference drug 2007 authorities. M/s News Anesthetic 85000/- Legalized COPP  Confirmation of Stetic S.A, dated 30-04- need to be me-too status. Careera 53N Manufacturer 14 submitted, Firm  Stability studies 50-09, has submitted as per Autipista 14$ per copy of COPP. ICH/WHO Medillin cartridge/ Zone IV-A Bagota Km, 22 Glass conditions. Guarne P.O. cartridge of Box 1759 1.8ml Antiquia, Medellin,

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Columbia.

191. M/s Ali Gohar SYSTANE Ultra Form-5A The product is Deferred for & Co (Pvt) Lubricant Eye not licensed in confirmation of me- Limited, State Drops Dy No :160 the USA, too status. If Life Building dated 23-04- however product is me-too, No. 1B I.I. Polyethylene 2011 available in the applicant shall Chundrigar Glycol 400, 15000/- market. The submit diferrential Road, Karachi NF……0.4% dated 23-04- COPP states that fee of Rs. 50000/-. Propylene 2011 “such over the Alcon glycol….0.3% 35000/- counter products Laboratories dated 26-03- marketed Inc. 6201 Artificial tears 14 without prior South clearance to this Freeway, Fort Manufacturer Rs. 921/- administration”. Worth Texas 10ml bottle USA Me-too status not confirmed.

192. M/s Allmed PENTIN Injection Form-5A PRIMAXIN Deferred for: Laboratories, 0.5g (USFDA)  Valid sole A-21/3, KDA Dy No :150 agency Scheme-1 Each vial contains: dated 20-06- Prepenem, agreement. Extension Opp. Imipenem….0.25g 11 Highnoon Labs, Legalized National Cilastatin….0.25g 15000/- Lahore COPP of the stadium dated 20-06- product. Karachi. Carbapenem 11  Stability data as 85000/- per WHO/ICH Zhejiang Hisun Manufacturer dated 30-04- conditions. Pharmaceutical 13 s, Co Ltd, No. 46 Waisha Rs. 930/- Road Jiajiang, per vial Distt. Taizhou City, Zhejiang Province China 193. -do- PENTIN Injection Form-5A PRIMAXIN Deferred for: 1g (USFDA)  Valid sole Dy No :150 agency Each vial contains: dated 20-06- Stanem, Cirin agreement. Imipenem….0.5g 11 Pharma, Hattar. Legalized Cilastatin….0. 5g 15000/- COPP of the dated 20-06- product.

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Carbapenem 11  Stability data as 85000/- per WHO/ICH Manufacturer dated 30-04- conditions. 13

Rs. 1800/- per vial

194. M/s A’raf OZAPEX 10mg Form-5A Zyprexa of Lilly Approved subject Pharma, Powder for solution USA. (US FDA) to compliance of 173, P-Block for injection Dy No :86 Import Policy for Gulberg-III dated 10-06- New dosage Finished Drugs and Lahore. Each vial contains: 11 form confirmation of Olanzapine……10 15000/- storage facility of M/s mg dated 20-06- importer. Pharmathen 11 S.A. Antipsychotic 85000/- Dervenakion 6, dated 20-09- Pallini, 15351, Manufacturer 13 Attikis, Greece, 195. M/s Novartis TOPOTECAN Form-5A Topotecan Deferred for Pharma EBEWE 1mg/ ml (USFDA) clarification (Pakistan) vial Dy. No. 101 regarding non- Limited, dated 10-09- New Strength availability of Karachi Each vial contains: 11 product in Austria Topotecan…….1m Product is and stability data as M/s Ebewe g 15000 dated licensed in the per Zone-IV A Pharma Ges. 10-09-15 exporting conditions. M.b.H Nfg, Anticancer 35000 dated country but is KG 01-07-13 not in the market MondseestraBe Manufacturer of exporting 11 AT-4866 Rs 5270 country. Unterach pack of 1’s Austria. 196. M/s Novartis TOPOTECAN Form-5A Topotecan Deferred for Pharma EBEWE 3mg/ 3ml (USFDA) clarification (Pakistan) vial Dy. No. 102 regarding non- Limited, dated 10-09- New Strength availability of Karachi Each vial contains: 11 product in Austria Topotecan…….1m Product is and stability data as M/s Ebewe g 15000 dated licensed in the per Zone-IV A Pharma Ges. 10-09-15 exporting conditions. M.b.H Nfg, Anticancer 35000 dated country but is KG 01-07-13 not in the market MondseestraBe Manufacturer of exporting 11 AT-4866 Rs 15810 country. Unterach pack of 1’s

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Austria.

197. M/s Novartis TOPOTECAN Form-5A Topotecan Deferred for: Pharma EBEWE 4mg/ 4ml (USFDA)  Stability data as (Pakistan) vial Dy. No. 102 per Zone-IV A Limited, dated 10-09- Hycamtin of conditions. Karachi Each vial contains: 11 GSK.  Complete fee as Topotecan…….4m the product is M/s Ebewe g 15000 dated Product is already me-too. Pharma Ges. 10-09-15 licensed in the  Clarification M.b.H Nfg, Anticancer 35000 dated exporting regarding non- KG 01-07-13 country but is availability of MondseestraBe Manufacturer not in the market product in 11 AT-4866 Rs 21080 of exporting Austria Unterach pack of 1’s country. Austria. 198. M/s Sind POLYMED Single Form-5A Deferred for: Medical Blood Bags with  Legalized free Stores, 13-B, Anticoagulant Dy No: 224 sale certificate, Block 6, CPDA-1 Solution dated 21-06- COPP/GMP. P.E.C.H.S 11  Accelerated and Shahrah-e- Each 100ml real time Faisal Karachi. Anticoagulant 15000 dated stability data as CPDA solution 21-06-11 per Zone-IV-A Poly Medicure USP contains: 85000 dated conditions. Ltd, Plot 104- Citric acid 02-04-13 105, 115, Sec, (anhydrous) Sec-59, USP….0.299gm HSIDC Sodium Citrate Industrial, (dihydrate) Ballabgarh- USP….2.63gm 121004, Monobasic Sod. Faridabad Phosphate…..0.222 Haryana India gm Dextrose (Monohydate) USP…3.190gm Adenine USP….0.0275gm Water for Injection USP….qs to 100ml

Surgical disposables

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199. -do- POLYMED double Form-5A Deferred for: Blood Bags with  Legalized free Anticoagulant Dy No: 223 sale certificate CPDA-1 Solution dated 21-06- COPP/ GMP. & one transfer bag 11  Accelerated and real time Each 100ml 15000 dated stability data as Anticoagulant 21-06-11 per Zone-IV-A CPDA solution 85000 dated conditions. USP contains: 02-04-13 Citric acid (anhydrous) USP….0.299gm Sodium Citrate (dihydrate) USP….2.63gm Monobasic Sod. Phosphate…..0.222 gm Dextrose (Monohydate) USP…3.190gm Adenine USP….0.0275gm Water for Injection USP….qs to 100ml

Surgical disposables 200. -do- POLYMED triple Form-5A Deferred for: Blood Bags with Legalized free sale Anticoagulant Dy No: 225 certificate CPDA-1 Solution dated 21-06- COPP/GMP. & two transfer bag 11 Accelerated and real time stability Each 100ml 15000 dated data as per Zone- Anticoagulant 21-06-11 IV-A conditions. CPDA solution 85000 dated USP contains: 02-04-13 Citric acid (anhydrous) USP….0.299gm Sodium Citrate (dihydrate) USP….2.63gm Monobasic Sod. Phosphate…..0.222 gm

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Dextrose (Monohydate) USP…3.190gm Adenine USP….0.0275gm Water for Injection USP….qs to 100ml

Surgical disposables 201. M/s Atco TROZET Tablet Form-5A Femara of Deferred for: Pharma Novartis  Legalized International Each film coated Dy. No. 77 (USFDA) COPP. (Pvt) Limited, tablet contains: dated 16-10-  Sole agency Karachi Letrozole 08 Femara of agreement. USP……2.5mg Novartis  Drug sale Dabur Pharma 15000 dated Pakistan license. Limited, Nonsteroidal 16-10-08 Village Aromatase Inhibitor 85000 dated Kishanpura PO 13-12-2013 Guru Majra USP Tehsil Rs. 8139 Nalagarah Pack of 28’s Distt. India 202. M/s Bajwa SOLOZOL 100mg Form-5A A-Hydrocort Deferred for: Sons, 169 Injection (USFDA)  Evidence of circular road Dy. No. 86 submission of lohari, Lahore. Each 7ml Injection dated 17-05- Hy-Cortisone of differential fee. contains: 11 Cirin Pharma,  Clarification that M/s Shanxi Hydrocortisone Hattar. product is Federal sodium 15000 dated approved in Pharmaceutical succinate…..100mg 17-05-11 reference drug s, Co. Ltd, 11 agencies as Huitong Road, Corticosteroid Rs. 70 per Hydrocortisone Jinzhong Analogue vial sodium succinate Shanxi China eq. to 100mg of Hydrocortisone; However the label claim and COPP is of the Hydrocortisone sodium succinate 100mg. Furthermore applied product is approved in reference

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agencies as freeze dried formulation, however form the manufacturing method submitted product specification submitted by the applicant it is evident that manufacture will fill directly powder in to the vials. This also requires clarification.  Accelerated and real time stability data as per Zone IV A conditions.  Outline of method of manufacture is required as the submitted flow diagram is of antibiotic.

203. -do- SOLOZOL 250mg Form-5A A-Hydrocort Deferred for: Injection (USFDA)  Evidence of Dy. No. 79 submission of Each 7ml Injection dated 17-05- differential fee. contains: 11  Clarification that Hydrocortisone product is sodium 15000 dated approved in succinate…..250mg 17-05-11 reference drug 120 per vial agencies as Corticosteroid Hydrocortisone Analogue sodium succinate eq. to 100mg of Hydrocortisone; However the label claim and COPP is of the Hydrocortisone sodium succinate

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100mg. Furthermore applied product is approved in reference agencies as freeze dried formulation, however form the manufacturing method submitted product specification submitted by the applicant it is evident that manufacture will fill directly powder in to the vials. This also requires clarification.  Accelerated and real time stability data as per Zone IV A conditions.  Outline of method of manufacture is required as the submitted flow diagram is of antibiotic.

204. -do- SOLOZOL 500mg Form-5A A-Hydrocort Deferred for: Injection (USFDA)  Evidence of Dy. No. 81 submission of Each 7ml Injection dated 17-05- differential fee. contains: 11  Clarification that Hydrocortisone product is sodium 15000 dated approved in succinate…..500mg 17-05-11 reference drug 300 per vial agencies as Corticosteroid Hydrocortisone Analogue sodium succinate eq. to 100mg of Hydrocortisone;

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However the label claim and COPP is of the Hydrocortisone sodium succinate 100mg. Furthermore applied product is approved in reference agencies as freeze dried formulation, however form the manufacturing method submitted product specification submitted by the applicant it is evident that manufacture will fill directly powder in to the vials. This also requires clarification.  Accelerated and real time stability data as per Zone IV A conditions.  Outline of method of manufacture is required as the submitted flow diagram is of antibiotic.

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Case No. 04: Deferred Cases

EVALUATOR III i. Medisure Pharma Karachi.

Following products of M/s Medisure Pharmaceuticals Karachi are deferred in the 237th meeting of Registration Board for clarification whether lyophilization procedure is mandatory for below mentioned formulations or not. Firms have now stated that lyophilized powder will be filled directly into the vials.

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S/N Name and Brand Name Type of International Remarks address of Form status in manufacturer (Proprietary name reference drug / Applicant + Dosage Form + Initial date, agencies / Strength) diary authorities Composition Fee Me-too status Pharmacological including Group differential GMP status as fee depicted in Finished product latest inspection Specification Demanded report (with Price / date) by the Pack size Evaluator 205. M/s Medisure LANSOCURE I.V Form-5 PREVACID IV Approved. Firm will Pharmaceutical Infusion (MHRA) import the ready to s Karachi Dy. No. 77 fill lyophilize Each vial contains: Dated 30- QPRO of Bosch powder and will not Lansoprazole 01-13 Pharma claim the product as ….30mg lyophilized. 20000 PPI As per PRC/ Manufacturer Pack of 1’s 206. -do- CLAROCIN I.V Form-5 Klaricid IV Approved. Firm will Infusion 500mg (MHRA) import the ready to Dy. No. 79 fill lyophilize Each vial contains: Dated 30- Klaricid IV od powder and will not Clarithromycin….. 01-13 Abbot Labs claim the product as 500mg lyophilized. 20000 Macrolide As per PRC/ Manufacturer Pack of 1’s 207. -do- AZTRIX-IV Form-5 ZEDBAC Approved. Firm will Infusion Powder for import the ready to Dy. No. 78 infusion fill lyophilize Each vial contains: Dated 30- powder and will not Azithromycin…..50 01-13 Azimycin claim the product as 0mg Infusion of lyophilized. 20000 Medicena Macrolide Pharma As per PRC/ Manufacturer Pack of 1’s

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ii. M/s Safe Pharmaceuticals Karachi

Following products of M/s Safe Pharmaceuticals Karachi are deferred in the 249th meeting of Registration Board for securitization as per approved checklist. The firm has submitted undertaking as approved in the 251st meeting of Registration Board and requested for Registration.

S/N Name and Brand Name Type of International Remarks address of Form status in manufacturer (Proprietary name reference drug / Applicant + Dosage Form + Initial date, agencies / Strength) diary authorities Composition Fee Me-too status Pharmacological including Group differential GMP status as fee depicted in Finished product latest inspection Specification Demanded report (with Price / date) by the Pack size Evaluator 208. M/s Safe ELERJE Injection Form-5 Chlorpheniramin Deferred for Pharmaceutical 10mg/ 2ml e injection confirmation of s Karachi Dy. No. 10mg/ml approval status by Each ampoule (USFDA) reference drug contains: 8000dated regulatory Chlorpheniramine 30-06-08 Chlorpheiramine authorities. meleate…..10mg/2 12000 dated Injection of M/s ml 23-02-15 Geofmann

Antihistamine As per PRC/ Pack of BP 2mlx50’s 2mlx100’s 209. -do- ESTA Tablet 1mg Form-5 Estazolam Approved Tablets Each tablet Dy. No. (USFDA) contains: Estazolam…..1mg 8000dated Esilgan of Helix 30-06-08 Pharma Karachi Tranquilizer, 12000 dated sedative & hypnotic 23-02-15

Manufacturer As per PRC

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210. -do- ESTA Tablet 2mg Form-5 Estazolam Approved Tablets Each tablet Dy. No. (USFDA) contains: Estazolam…..2mg 8000dated Esilgan of Helix 30-06-08 Pharma Karachi Tranquilizer, 12000 dated sedative & hypnotic 23-02-15

Manufacturer As per PRC

211. -do- AMATAMERZ Form-5 Amantadine Approved Capsules 100mg Capsules Dy. No. (USFDA) Each capsule contains: 8000dated Virofral of Amantadine 30-06-08 English Pharma Hydrochloride…10 12000 dated 0mg 23-02-15

Antiviral As per PRC

BP 212. -do- ADRENALINE Form-5 Epinephrine Approved Injection 1mg/ml Injection Dy. No. (USFDA) Condition will be Each 1ml ampoule mentioned in contains: 8000dated Adrenaline registration letter Adrenaline…..1mg 11-02-09 Injection of that firm will 12000 dated Venus Pharma purchase and Adrenergic Agonist 23-02-15 perform installation and operational USP As per PRC qualifications of TOC analyser and liquid particle counter in six months time.

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iii. M/s Venus Pharmaceuticals Lahore.

Following product of M/s Venus Pharmaceuticals were deferred in the 249th meeting of Registration Board because of submission of Legalized GMP certificate of the manufacturer of the pellets along with COA and stability data. The firm has now submitted the aforesaid documents and requested for registration.

S/N Name and Brand Name Type of Form International Remarks address of status in manufact (Proprietary name + Initial date, reference drug urer / Dosage Form + Strength) diary agencies / Applicant Composition authorities Fee including Pharmacological Group differential fee Me-too status

Finished product Demanded Price GMP status as Specification / Pack size depicted in latest inspection report (with date) by the Evaluator 213. M/s Venus Hefzol – 20 Form 5 NEXIUM Approved Pharma, Rs. 20,000/- 20mg capsules 23 Km, Each Capsule Dated 05-03-2015 US FDA Multan contains: Dy. No. 1390 NEXUM Road, Esomeprazole R&I M/s Getz Lahore. Magnesium Rs. 80,000/- trihydrate eq. to Dated 30-04-2015 Legalized GMP Esomeprazole Dy. No. Nil of pellets …………. 20mg Price: 250/- provider Proton pump 2x7’s provided. Inhibitor

Manufacturers Specifications

Source: M/s Ocean Pharmaoat Pvt. Ltd., Plot No. 44, Co-operative Industrial Estate, Gandhi Nagar, Balanagar, Hyderabad, 500037, India

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214. -do- Hefzol – 40 Form 5 NEXIUM Approved Rs. 20,000/- 40mg capsules Each Capsule Dated 05-03-2015 US FDA contains: Dy. No. 1391 NEXUM Esomeprazole R&I M/s Getz Magnesium Rs. 80,000/- trihydrate eq. to Dated 30-04-2015 Legalized GMP Esomeprazole Dy. No. Nil of pellets …………. 40mg Price: 300/- provider 2x7’s provided. Proton pump Inhibitor

Manufacturers Specifications

Source: M/s Ocean Pharmaoat Pvt. Ltd., Plot No. 44, Co- operative Industrial Estate, Gandhi Nagar, Balanagar, Hyderabad, 500037, India

iv. M/s Ali Gohar & Co (Pvt) Limited Karachi

M/s Ali Gohar & Co (Pvt) Limited Karachi has applied for registration of Pataday 0.2 % ophthalmic solution which will be imported from M/s Alcon Laboratories, Inc 6201 South Freeway, Fort Worth, Texas 76134, USA. The case was considered in the 247th & 249th meeting of Registration Board and deferred to submit stability data as per Zone-IV A conditions. The firm submitted that based on the ICH guidelines drug products packed in semi permeable containers the stability conditions of 40±2C/ 15±5 represents the worst case conditions. The stability data of the firm is evaluated as per ICH stability conditions for semi permeable containers as the applied formulation is packed in LDPE bottle. The data submitted is complete as per said conditions. The firm requested for registration of below mentioned product.

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S/N Name and Brand Name Type of International Remarks address of Form status in manufacture (Proprietary name reference drug r / Applicant + Dosage Form + Initial date, agencies / Strength) diary authorities Composition Fee Me-too status Pharmacological including Group differential GMP status as fee depicted in Finished product latest inspection Specification Demanded report (with Price / date) by the Pack size Evaluator 215. Applicant PATADAY Form-5A Alcon Labs, Deferred for complete fee M/s Ali 0.2% Dy. No. 29 USA. (US FDA) as product is me-too in the Gohar dated 02-03- country. & Co (Pvt) Each ml of 2010 Me-too: Limited, State sterile 15,000/- Life Building ophthalmic dated No. 1B solution 02-03-2010 I.I contains: 35,000/- Chundrigar Olopatadine dated Road P.O. HCL 2.22mg 26-03-13 Box equivalent to Rs. 904/- 5167 Karachi. Olopatadine… Pack of 4ml Manufacture …..2mg Bottle r containing Alcon Anti-allergic 2.5ml of Laboratories, solution Inc Manufacturer 6201 South Freeway, Fort Worth, Texas 76134, USA

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Case No.V: Review Items deferred in 250th Meeting

Following formulations are referred to the review committee vide letter No. F.3-1/2014-PEC dated 16-12-14. These below mentioned formulations are discussed in the 250th meeting and deferred for confirmation in reference agencies. The firm has now submitted reply which is as follows.

Sr. No Name of Product Me-Too Status Decision-249 International Availability 216. Costa 2% Syrup 1. Rhinathiol Deferred for Approved Each 5ml contains: 2%, confirmation of Carbocisteine………. (Sanofi avail ability of (Rhinathiol Syrup 100mg Aventis) formulation in of Sanofi Aventis (Manufacturer’s 2. Carbex reference drug France. Ref: Specification) (Platinum) agencies approved ANSM France) 3. Muflex in 249th meeting (Kaizen) of Registrtion Contraindicated 4. Rhinex Board. below two years (Opal) of age. The local package insert for Rhinathiol 2% syrup (for all existing and new manufactrers) will be updated to reflect this new contraindication. Ref: ANSM France Costa Pro Syrup 1. Rhinathiol Deferred for Approved 217. Each 5ml contains: Prometh confirmation of Carbocisteine …….. (Sanofi- availability of (Rhinathiol 100mg Aventis) formulation in Promethazine Promethazine HCl…. 2. Rhinex-P reference drug Syrup of Sanofi 2.5mg (Opal) agencies approved Aventis France. (Manufacturer’s 3. Carbex plus in 249th meeting Ref: ANSM Specification) (Platinum) of Registrtion France) 4. Muflex Pro Board. (Kaizen) Contraindicated below two years of age. The local package insert for Rhinathiol 2% syrup (for all existing and new manufactrers) will be updated to reflect this new

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contraindication. Ref: ANSM France 218. Buterol oral solution 1. Btno oral Deferred for Approved Each 5ml contains: solution confirmation of Bambuterol HCl….. 5mg (Genix) availability of (Bambec Oral (Manufacturer’s 2. Bambuzaf formulation in solution 1mg/ml. Specification) (Zafa) reference drug Ref: bFARM 3. Butral agencies approved Germany) (Shaheen) in 249th meeting 4. Pulmitac of Registrtion (Platinum) Board. 5. Pulmiterol (Kaizen) 6. Ordain (SJ&G) 7. Bambac (Opal) 8. Bambia (MKB)

Case No.06: Deferred Cases of Pregabalin EVALUATOR III S/N Name and Brand Name Type of International Remarks address of Form status in manufacturer (Proprietary name reference drug / Applicant + Dosage Form + Initial date, agencies / Strength) diary authorities Composition Fee Me-too status Pharmacological including Group differential GMP status as fee depicted in Finished product latest inspection Specification Demanded report (with Price / date) by the Pack size Evaluator 219. M/s EPIGABALIN Form-5 LYRICA Approved as firm has Geofmann Capsules 75mg Capsules (25, 50, rectified shortcomings Pharmaceutical Dy. No 75, 100, s, 20/23 E.I. Each capsule 150,200, 225 and Lines Dr. Daud contains: 8000/- dated 300mg) Pota Road Pregabalin….75mg 29-01-09 US FDA Karachi. 12000/- Anti-epileptic dated 18-12- GABICA 14 Capsules (50, 75, Manufacturer 100, 150 and

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As per SRO 300mg) Getz 220. -do- EPIGABALIN Form-5 LYRICA Approved as firm has Capsules 150mg Capsules (25, 50, rectified shortcomings Dy. No 75, 100, Each capsule 150,200, 225 and contains: 8000/- dated 300mg) Pregabalin….75mg 29-01-09 US FDA 12000/- Anti-epileptic dated 18-12- GABICA 14 Capsules (50, 75, Manufacturer 100, 150 and As per SRO 300mg) Getz

221. -do- EPIGABALIN Form-5 LYRICA Approved as firm has Capsules 300mg Capsules (25, 50, rectified shortcomings Dy. No 75, 100, Each capsule 150,200, 225 and contains: 8000/- dated 300mg) Pregabalin….300m 29-01-09 US FDA g 12000/- dated 18-12- GABICA Anti-epileptic 14 Capsules (50, 75, 100, 150 and Manufacturer As per SRO 300mg) Getz

222. M/s Gray’s Pregab Capsules Form-5 LYRICA Deferred for: Pharmaceutical 50mg Capsules (25, 50,  Latest GMP s, Islamanbad. Dy. No 75, 100, inspection report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000/ dated 300mg) in 251st meeting of Pregabalin….50mg 20-03-09 US FDA registration board. 12000/-  Signatures on Form-5 Anti-epileptic dated 21-01- GABICA and its relevant 15 Capsules (50, 75, annexure by QC & Manufacturer 100, 150 and production In charge. As per 300mg) SRO/ pack Getz of 14’s 223. -do- Pregab Capsules Form-5 LYRICA Deferred for: 75mg Capsules (25, 50,  Latest GMP Dy. No 75, 100, inspection report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000/ dated 300mg) in 251st meeting of Pregabalin….75mg 20-03-09 US FDA registration board.

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12000/-  Signatures on Form-5 Anti-epileptic dated 21-01- GABICA and its relevant 15 Capsules (50, 75, annexure by QC & Manufacturer 100, 150 and production In charge. As per 300mg) SRO/ pack Getz of 14’s 224. -do- Pregab Capsules Form-5 LYRICA Deferred for: 100mg Capsules (25, 50,  Latest GMP Dy. No 75, 100, inspection report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000/ dated 300mg) in 251st meeting of Pregabalin….100m 20-03-09 US FDA registration board. g 12000/-  Signatures on Form-5 dated 21-01- GABICA and its relevant Anti-epileptic 15 Capsules (50, 75, annexure by QC & 100, 150 and production In charge. Manufacturer As per 300mg) SRO/ pack Getz of 14’s 225. -do- Pregab Capsules Form-5 LYRICA Deferred for: 150mg Capsules (25, 50,  Latest GMP Dy. No 75, 100, inspection report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000/ dated 300mg) in 251st meeting of Pregabalin….150m 20-03-09 US FDA registration board. g 12000/-  Signatures on Form-5 dated 21-01- GABICA and its relevant Anti-epileptic 15 Capsules (50, 75, annexure by QC & 100, 150 and production In charge. Manufacturer As per 300mg) SRO/ pack Getz of 14’s 226. M/s EPharam PAGABIN Form-5 LYRICA Deferred for: Laboratories, Capsules 50mg Capsules (25, 50,  Evidence of submission A-40, Road Dy. No 75, 100, of initial fee. No.1, S.I.T.E Each capsule 150,200, 225 and  Latest GMP inspection Super Highway contains: 12000/- 300mg) report. Industrial Pregabalin….50mg dated 21-07- US FDA  Undertaking approved Area, North 15 in 251st meeting of Karachi Anti-epileptic GABICA registration board. 200/ pack of Capsules (50, 75, Manufacturer 2x7’s 100, 150 and 300mg) Getz

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227. -do- PAGABIN Form-5 LYRICA Deferred for: Capsules 75mg Capsules (25, 50,  Evidence of submission Dy. No 55- 75, 100, of initial fee. Each capsule R-II dated 150,200, 225 and  Latest GMP inspection contains: 05-01-2011 300mg) report. Pregabalin….75mg US FDA  Undertaking approved 12000/- in 251st meeting of Anti-epileptic dated 21-07- GABICA registration board. 15 Capsules (50, 75, Manufacturer 100, 150 and 250/ pack of 300mg) 2x7’s Getz 228. -do- PAGABIN Form-5 LYRICA Deferred for: Capsules 150mg Capsules (25, 50,  Evidence of submission Dy. No 35- 75, 100, of initial fee. Each capsule R-II dated 150,200, 225 and  Latest GMP inspection contains: 05-01-2011 300mg) report. Pregabalin….150m US FDA  Undertaking approved g 12000/- in 251st meeting of dated 21-07- GABICA registration board. Anti-epileptic 15 Capsules (50, 75, 100, 150 and Manufacturer 375/ pack of 300mg) 2x7’s Getz 229. -do- PAGABIN Form-5 LYRICA Deferred for: Capsules 300mg Capsules (25, 50,  Evidence of submission Dy. No 75, 100, of initial fee. Each capsule 150,200, 225 and  Latest GMP inspection contains: 12000/- 300mg) report. Pregabalin….300m dated 21-07- US FDA  Undertaking approved g 15 in 251st meeting of GABICA registration board. Anti-epileptic 700/ pack of Capsules (50, 75, 2x7’s 100, 150 and Manufacturer 300mg) Getz 230. M/s Winbrains PREGABA Form-5 LYRICA Deferred for latest GMP Research Labs, Capsules 50mg Capsules (25, 50, inspection report. Hattar. Dy. No 131 75, 100, Each capsule dated 27-05- 150,200, 225 and contains: 11 300mg) Pregabalin….50mg US FDA 8000 dated Anti-epileptic 24-05-11 GABICA 12000/- Capsules (50, 75, Manufacturer dated 11-07- 100, 150 and 14 300mg) Getz

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As per PRC Inspection of the firm was carried out on 17-03-14 by the area FID and nothing in violation of GMP 231. M/s EG PREGABA Form-5 LYRICA Deferred for: Pharmaceutical Capsules 300mg Capsules (25, 50,  Latest GMP s, Islamabad. Dy. No 131 75, 100, inspection report. Each capsule dated 27-05- 150,200, 225 and  Undertaking approved contains: 11 300mg) in 251st meeting of Pregabalin….300m US FDA registration board. g 8000 dated 24-05-11 GABICA Anti-epileptic 12000/- Capsules (50, 75, dated 11-07- 100, 150 and Manufacturer 14 300mg) Getz As per SRO/ 14’s 232. M/s Schazoo ULTRAGAB Form-5 LYRICA Approved Pharmaceutical Capsules 50mg Capsules (25, 50, Labs , Dy. No 75, 100, Sheikhupura. Each capsule 150,200, 225 and contains: 8000 dated 300mg) Pregabalin….50mg 20-04-10 US FDA 12000/- Anti-epileptic dated 01-12- GABICA 14 Capsules (50, 75, Manufacturer 100, 150 and Rs . 57.14 300mg) per capsule. Getz Rs. 800/ Pack of 2x7’s 233. -do- ULTRAGAB Form-5 LYRICA Approved Capsules 75mg Capsules (25, 50, Dy. No 75, 100, Each capsule 150,200, 225 and contains: 8000 dated 300mg) Pregabalin….75mg 20-04-10 US FDA 12000/- Anti-epileptic dated 01-12- GABICA 14 Capsules (50, 75, Manufacturer 100, 150 and Rs . 71.43 300mg) per capsule. Getz

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Rs. 1000/ Pack of 2x7’s 234. -do- ULTRAGAB Form-5 LYRICA Approved Capsules 100mg Capsules (25, 50, Dy. No 75, 100, Each capsule 150,200, 225 and contains: 8000 dated 300mg) Pregabalin….100m 20-04-10 US FDA g 12000/- dated 01-12- GABICA Anti-epileptic 14 Capsules (50, 75, 100, 150 and Manufacturer Rs . 92.86 300mg) per capsule. Getz Rs. 1300/ Pack of 2x7’s 235. -do- ULTRAGAB Form-5 LYRICA Approved Capsules 300mg Capsules (25, 50, Dy. No 75, 100, Each capsule 150,200, 225 and contains: 8000 dated 300mg) Pregabalin….300m 20-04-10 US FDA g 12000/- dated 01-12- GABICA Anti-epileptic 14 Capsules (50, 75, 100, 150 and Manufacturer Rs . 178.58 300mg) per capsule. Getz Rs. 2500/ Pack of 2x7’s 236. M/s Caraway REGAB Tablets Form-5 Not found in Rejected as the formulation Pharmaceutical 50mg reference drug is not approved by any s, Islamabad. Dy. No agencies reference drug regulatory Each tablet authorities. contains: 8000 dated Pregabalin….50mg 31-12-08 12000/- Anti-epileptic dated 19-11- 14 Manufacturer As per policy of MOH 237. -do- REGAB Tablets Form-5 Not found in Rejected as the formulation 75mg reference drug is not approved by any

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Dy. No agencies reference drug regulatory Each tablet authorities. contains: 8000 dated Not found Pregabalin….75mg 31-12-08 12000/- Anti-epileptic dated 19-11- 14 Manufacturer As per policy of MOH 238. -do- REGAB Tablets Form-5 Not found in Rejected as the formulation 100mg reference drug is not approved by any Dy. No agencies reference drug regulatory Each tablet authorities. contains: 8000 dated Pregabalin….100m 31-12-08 g 12000/- dated 19-11- Anti-epileptic 14

Manufacturer As per policy of MOH 239. -do- REGAB Tablets Form-5 Not found in Rejected as the formulation 150mg reference drug is not approved by any Dy. No agencies reference drug regulatory Each tablet authorities. contains: 8000 dated Pregabalin….150m 31-12-08 g 12000/- dated 19-11- Anti-epileptic 14

Manufacturer As per policy of MOH 240. M/s Panacea PYRICA Capsules Form-5 LYRICA Deferred for: Pharmaceutical 50mg Capsules (25, 50,  Latest GMP inspection s, Islamabad Dy. No 75, 100, report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000 dated 300mg) in 251st meeting of Pregabalin….50mg 14-11-08 US FDA registration board. 12000/- Anti-epileptic dated 13-01- GABICA 15 Capsules (50, 75, Manufacturer 100, 150 and As per PRC 300mg)

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Getz 241. -do- PYRICA Capsules Form-5 LYRICA Deferred for: 100mg Capsules (25, 50,  Latest GMP inspection Dy. No 75, 100, report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000 dated 300mg) in 251st meeting of Pregabalin….100m 14-11-08 US FDA registration board. g 12000/- dated 13-01- GABICA Anti-epileptic 15 Capsules (50, 75, 100, 150 and Manufacturer As per PRC 300mg) Getz 242. M/s Medicraft GABATIL Form-5 LYRICA Deferred for: Pharmaceutical Capsules 75mg Capsules (25, 50,  Latest GMP s, Peshawar Dy. No 91 75, 100, inspection report. Each capsule dated 03-06- 150,200, 225 and  Undertaking approved contains: 10 300mg) in 251st meeting of Pregabalin….75mg US FDA registration board. 8000 dated  Evidence of Anti-epileptic 02-06-10 GABICA submission of Capsules (50, 75, differential fee. Manufacturer As per 100, 150 and SRO/ 14’s 300mg) Getz

243. -do- GABATIL Form-5 LYRICA Deferred for: Capsules 100mg Capsules (25, 50,  Latest GMP Dy. No 90 75, 100, inspection report. Each capsule dated 03-06- 150,200, 225 and  Undertaking approved contains: 10 300mg) in 251st meeting of Pregabalin…100mg US FDA registration board. 8000 dated  Evidence of Anti-epileptic 02-06-10 GABICA submission of Capsules (50, 75, differential fee. Manufacturer As per 100, 150 and SRO/ 10’s 300mg) Getz

244. M/s Espoir PREVENT Form-5 LYRICA Deferred for: Pharmaceutical Capsules 75mg Capsules (25, 50,  Latest GMP inspection s, Karachi Dy. No 75, 100, report. Each capsule 1704-R-II 150,200, 225 and  Undertaking approved contains: dated 23-10- 300mg) in 251st meeting of Pregabalin…75mg 12 US FDA registration board.

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Anti-epileptic 20000 dated GABICA 23-10-12 Capsules (50, 75, Manufacturer 100, 150 and As per SRO 300mg) Getz

245. -do- PREVENT Form-5 LYRICA Deferred for: Capsules 150mg Capsules (25, 50,  Latest GMP inspection Dy. No 75, 100, report. Each capsule 1697-R-II 150,200, 225 and  Undertaking approved contains: dated 23-10- 300mg) in 251st meeting of Pregabalin…150mg 12 US FDA registration board.

Anti-epileptic 20000 dated GABICA 23-10-12 Capsules (50, 75, Manufacturer 100, 150 and As per SRO 300mg) Getz

246. -do- PREVENT Form-5 LYRICA Deferred for: Capsules 300mg Capsules (25, 50,  Latest GMP inspection Dy. No 75, 100, report. Each capsule 1710-R-II 150,200, 225 and  Undertaking approved contains: dated 23-10- 300mg) in 251st meeting of Pregabalin…300mg 12 US FDA registration board.

Anti-epileptic 20000 dated GABICA 23-10-12 Capsules (50, 75, Manufacturer 100, 150 and As per SRO 300mg) Getz 247. M/s Swan Pragab Tablets Form-5 Not found in Rejected as the formulation Pharmaceutical 150mg reference drug is not approved by any s, Islamabad Dy. No agencies reference drug regulatory Each tablet 5272 dated authorities. contains: 28-06-10 Pregabalin…150mg 8000 dated Anti-epileptic 25-06-10 12000 dated Manufacturer 10-06-14

As per SRO 248. M/s Le PANGAB Capsules Form-5 LYRICA Deferred for: Mendoza Plot 50mg Capsules (25, 50,  Latest GMP inspection No. 7, Sector Dy. No 75, 100, report. 23 Korangi Each capsule 150,200, 225 and  Undertaking approved Industrial Area contains: 8000 dated 300mg)

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Karachi Pregabalin…50mg 26-01-10 US FDA in 251st meeting of 12000 dated registration board. Anti-epileptic 02-02-15 GABICA Capsules (50, 75, Manufacturer Rs. 660/ 100, 150 and pack of 14’s 300mg) Getz 249. -do- PANGAB Capsules Form-5 LYRICA Deferred for: 100mg Capsules (25, 50,  Latest GMP inspection Dy. No 75, 100, report. Each capsule 150,200, 225 and  Undertaking approved contains: 8000 dated 300mg) in 251st meeting of Pregabalin…100mg 26-01-10 US FDA registration board. 12000 dated Anti-epileptic 02-02-15 GABICA Capsules (50, 75, Manufacturer Rs. 1200/ 100, 150 and pack of 14’s 300mg) Getz 250. M/s Sante ZUREG Capsules Form-5 LYRICA Deferred for undertaking (Pvt) Limited 50mg Capsules (25, 50, approved in 251st meeting Karachi Dy. No 256 75, 100, of registration board. Each capsule dated 21-01- 150,200, 225 and contains: 11 300mg) Pregabalin…50mg US FDA 8000 dated Anti-epileptic 21-01-11 GABICA 12000 dated Capsules (50, 75, Manufacturer 17-04-14 100, 150 and 300mg) Rs. 175/ Getz pack of 14’s Inspection of the firm was carried out on 28,29 May 2015 by the area FID where he concluded that management has positive attitude towards GMP complianace 251. -do- ZUREG Capsules Form-5 LYRICA Deferred for undertaking 75mg Capsules (25, 50, approved in 251st meeting Dy. No 257 75, 100, of registration board. Each capsule dated 21-01- 150,200, 225 and contains: 11 300mg)

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Pregabalin…75mg US FDA 8000 dated Anti-epileptic 21-01-11 GABICA 12000 dated Capsules (50, 75, Manufacturer 17-04-14 100, 150 and 300mg) Rs. 250/ Getz pack of 14’s 252. -do- ZUREG Capsules Form-5 LYRICA Deferred for undertaking 100mg Capsules (25, 50, approved in 251st meeting Dy. No 260 75, 100, of registration board. Each capsule dated 21-01- 150,200, 225 and contains: 11 300mg) Pregabalin…100mg US FDA 8000 dated Anti-epileptic 21-01-11 GABICA 12000 dated Capsules (50, 75, Manufacturer 17-04-14 100, 150 and 300mg) Rs. 250/ Getz pack of 14’s 253. ZUREG Capsules Form-5 LYRICA Deferred for undertaking 300mg Capsules (25, 50, approved in 251st meeting Dy. No 261 75, 100, of registration board. Each capsule dated 21-01- 150,200, 225 and contains: 11 300mg) Pregabalin…300mg US FDA 8000 dated Anti-epileptic 21-01-11 GABICA 12000 dated Capsules (50, 75, Manufacturer 17-04-14 100, 150 and 300mg) Rs. 250/ Getz pack of 14’s

DDC-PEC-I

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S/N Name and Brand Name Type of Remarks on the Decision address of (Proprietary name + Dosage Form formulation (if manufacturer / Form + Strength) any) including Applicant Initial date, International Composition diary status in stringent drug Pharmacological Group Fee including regulatory differential agencies / Finished product fee authorities Specification Demanded Me-too status Price / Pack size GMP status as depicted in latest inspection report (with date) by the Evaluator 254. M/s Inshal TS3 Injection. Form-5 TRI-S3 Injection Deferred for: Pharmaceuticals Injection Dy. No: 278 of M/s Attabak.  Distillation Plot No.2 Street Each ml contains: Rs.8000/- (Me too not Assembly SS 2 national Sulfamerazine……100mg Dated 08-01- confirmed)  Installation of industrial zone Sulfadiazine………60mg 2011 International all the rawat Sulfathiazole………40mg 12,000/- dated availability not instrument Islamabad. Trimethoprim………40mg 01-11-2013 provided. which are (Antibacterial) 50ml, 100ml / deficient for Inshal Specs Decontrolled testing / analysis of finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of

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the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly). 255. M/s Inshal Dexa Shell Injection. Form-5 Sulfa super Deferred for: Pharmaceuticals Injection Dy. No: 289 injection 33.30%  Distillation Plot No.2 Street Each ml contains: Rs.8000/- of M/s Attabak. Assembly SS 2 national Sulfadimadine Dated 08-01- International  Installation of industrial zone Sodium……..333.3mg 2011 availability not all the rawat (Antibacterial) Rs. 12,000/- provided. instrument Islamabad. Inshal Specs Dated 01-11- which are 2013 deficient for 50ml, 100ml, testing / 250ml / analysis of Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify

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fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly). 256. M/s Inshal Oxy Shell 20% Injection. Form-5 Oxy L 20 Deferred for: Pharmaceuticals Injection Dy. No: 293 Injection of M/s  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Attabak. Assembly SS 2 national Oxytetracycline HCl….200mg dated 08-01- International  Installation of industrial zone (Antibacterial) 2011 availability not all the rawat BP specs Rs.12,000/- provided. instrument Islamabad. dated 01-11- which are 2013 deficient for 10ml, 50ml, testing / 100ml, / analysis of Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies /

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short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly). 257. M/s Inshal Spyracin Injection. Form-5 Tylogenta Deferred for: Pharmaceuticals Injection Dy. No: 279 Injection of M/s  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Attabak Pharma. Assembly SS 2 national Gentamycin Sulphate…25mg dated 08-01- International  Installation of industrial zone Tylosin Tartrate………50mg 2011 availability not all the rawat (Antibiotec) Rs.12,000/- provided. instrument Islamabad. Inshal Specs dated 01-11- which are 2013 deficient for 50ml, 100ml, testing / 250ml, / analysis of Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify

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that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly). 258. M/s Inshal Oxyshell 5% Injection. Form-5 Terramycin Deferred for: Pharmaceuticals Injection Dy. No: 295 Injectable  Distillation Plot No.2 Street Each ml contains: Rs.8000/- solution by M/s Assembly SS 2 national Oxytetracycline HCl…50mg dated 08-01- Ghazi brothers  Installation of industrial zone (Antibictarial,) 2011 Karachi. all the rawat BP Specs Rs.12,000/- International instrument Islamabad. dated 01-11- availability not which are 2013 provided. deficient for 10ml, 50ml, testing / 100ml, / analysis of Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm

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manufacturing injectable products in the absence of facility of WFI (Distillation assembly). 259. M/s Inshal Meloxishell Injection. Form-5 Loxicon Injection Deferred for: Pharmaceuticals Liquid Injection Dy. No: 286 of M/s Vetcon  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Pharmaceuticals Assembly SS 2 national Meloxicam…….10mg dated 08-01- Azad Kashmir  Installation of industrial zone (NSAID) 2011 all the rawat Manufacturer Specs. Rs.12,000/- instrument Islamabad. dated 01-11- which are 2013 deficient for 50ml, 100ml, testing / / Decontrolled analysis of finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable

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products in the absence of facility of WFI (Distillation assembly). 260. M/s Inshal Emria Shell Powder. Form-5 Pulmotin Water Deferred for: Pharmaceuticals Water soluble powder Dy. No: 79 soluble powder of  Distillation Plot No.2 Street Each 1000g contains: Rs.8000/- M/s Attabake Assembly SS 2 national Doxycycline HCl….200g dated 05-11- Pharma  Installation of industrial zone Tylosin tartrate…….100g 2010 all the rawat Colistin sulphate……480MIU Rs.12,000/- instrument Islamabad. Bromhexine HCl…….5g 30g, 50g, which are (Anti-bacterial) 100g, 250g, deficient for Specs not provided. 500g, 1kg, testing / 5kg, 10kg, analysis of 25kg / finished Decontrolled products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of

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facility of WFI (Distillation assembly). 261. M/s Inshal Ivoshell Injection. Form-5 Ivotec of M/s Star Deferred for: Pharmaceuticals Liquid injection Dy. No: 280 Laboratories  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Assembly SS 2 national Ivermectin (B.P)….10mg dated 08-01-  Installation of industrial zone (Anthelmentic) 2011 all the rawat Rs.12,000/- instrument Islamabad. dated. 01-11- which are 2013 deficient for 10ml,30ml, testing / 50ml, 100ml, analysis of / Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation

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assembly). 262. M/s Inshal Ketohell Injection. Form-5 Profenol injection Deferred for: Pharmaceuticals Liquid injection Dy. No: 282 of M/s Leads  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Pharma Assembly SS 2 national Ketprofen……100mg dated 08-01-  Installation of industrial zone (Analgesic, Anti-inflammatory 2011 all the rawat agent) Rs.12,000/- instrument Islamabad. dated. 01-11- which are 2013 deficient for 50ml, 100ml, testing / / Decontrolled analysis of finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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263. M/s Inshal Coccicide Powder. Form-5 Cocisol W.D Deferred for: Pharmaceuticals Water soluble powder Dy. No: 40 Powder of S.A  Distillation Plot No.2 Street Each1000gm powder contains: Rs.8000/- International Assembly SS 2 national Sulphmerazine Sodium…200g dated 08-11- Chem Pharma.  Installation of industrial zone Sulphaquinoxaline 2010 Me too not all the rawat Sodium………………25g Rs.12,000/- correct as it also instrument Islamabad. Pyrimethamine………25g Dated.30-12- contain which are Vitamin A …………..15MIU 2013 Furaltadone HCl. deficient for Vitamin K3 50ml, 100ml, testing / (Coccidiocidal) / Decontrolled analysis of Specs not provided finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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264. M/s Inshal Genta Shell 20% Injection. Form-5 Gentabak 20% of Deferred for: Pharmaceuticals Liquid Injection Dy. No: 296 M/s Attabak  Distillation Plot No.2 Street Each100ml contains: Rs.8000/- Pharma Assembly SS 2 national Gentamycin sulphate dated 08-01-  Installation of industrial zone (B.P)…..20g 2011 all the rawat (Antibiotic) Rs.12,000/- instrument Islamabad. Inshal Specs. Dated.01-11- which are 2013 deficient for 50ml, 100ml, testing / / Decontrolled analysis of finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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265. M/s Inshal Predni Shell Injection. Form-5 CRD super Deferred for: Pharmaceuticals Liquid Injection Dy. No: 276 injection of M/s  Distillation Plot No.2 Street Each1mll contains: Rs.8000/- Attabak. Assembly SS 2 national Tylosin Tartrate……..60mg dated 08-01- (Composition of  Installation of industrial zone Colistin Sulphate……10mg 2011 me too differ all the rawat Streptomycin Rs.12,000/- from given instrument Islamabad. sulphate….100mg Dated.01-11- composition) which are (Antibacteril) 2013 deficient for Inshal Specs. 10ml, 20ml, testing / 50ml, 100ml, analysis of / Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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266. M/s Inshal Genta Shell Plus Injection. Form-5 Gentabak Plus of Deferred for: Pharmaceuticals Liquid Injection Dy. No: 283 M/s Attabak  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Pharma Assembly SS 2 national Gentamycin sulphate….30mg dated 08-01-  Installation of industrial zone Trimethoprim…………25mg 2011 all the rawat Sulfadimadine………125mg Rs.12,000/- instrument Islamabad. (Antibacterial) Dated.01-11- which are 2013 deficient for 50ml, 100ml, testing / / Decontrolled analysis of finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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267. M/s Inshal Genta Shell Injection. Form-5 Anti CRD Deferred for: Pharmaceuticals Liquid Injection Dy. No: 288 Injection of M/s  Distillation Plot No.2 Street Each 100ml contains: Rs.8000/- Attabak Pharma Assembly SS 2 national Gentamycin sulphate…..5gm dated 08-01-  Installation of industrial zone Tylosin Tartrate ……10gm 2011 all the rawat Colistin Sulphate…….60MIU Rs.12,000/- instrument Islamabad. (Antibiotec) Dated.01-11- which are Manufacturer Specification. 2013 deficient for 50ml, 100ml, testing / / Decontrolled analysis of finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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268. M/s Inshal Diaprim Injection. Form-5 Trisulf Injection Deferred for: Pharmaceuticals Liquid Injection Dy. No: 275 of M/s S.J&G  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Fazul Ellahe Pvt Assembly SS 2 national Trimethoprim…….80gm dated 08-01- Ltd.  Installation of industrial zone Sulfadiazine……400mg 2011 all the rawat (Antibacterial) Rs.12,000/- instrument Islamabad. Inshal specs. Dated.01-11- which are 2013 deficient for 10ml,50ml, testing / 100ml, / analysis of Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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269. M/s Inshal Ivoshell Super Injection. Form-5 Ivobak C Deferred for: Pharmaceuticals Liquid Injection Dy. No: 291 Injection of M/s  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Attabak Pharma Assembly SS 2 national Ivermectin…..10mg dated 08-01-  Installation of industrial zone Clorsolon……100mg 2011 all the rawat (Anthelmentic) Rs.12,000/- instrument Islamabad. Dated.01-11- which are 2013 deficient for 10ml, 20ml, testing / 50ml, 100ml, analysis of / Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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270. M/s Inshal PD Shell Injection. Form-5 Penacort Injection Deferred for: Pharmaceuticals Liquid Injection Dy. No: 277 of M/s Selmore  Distillation Plot No.2 Street Each ml contains: Rs.8000/- Pharma Assembly SS 2 national Prednisolone Acetate….7.5mg dated 08-01-  Installation of industrial zone Dexamethamethasone sodium 2011 all the rawat phosphate……2.5mg Rs.12,000/- instrument Islamabad. (Corticosteroids) Dated.01-11- which are 2013 deficient for 10ml, 30ml, testing / 50ml, 100ml, analysis of / Decontrolled finished products  Copy of official monograph.  Me too status be provided for all the products.  Statement of the firm for one pack size as per procedure of the board.  Quality Assurance Division shall be requested to conduct inspection of the firm by the FID to verify fulfillment of deficiencies / short comings and to verify that how the firm manufacturing injectable products in the absence of facility of WFI (Distillation assembly).

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Case No. 07. Registration Applications of New License /New Section/ Additional sections.

Capsule, General Antibiotic section: DML No. 000809, dated 25-02-2015) 271. M/s Cyclin-M 100 mg Form 5 AKAMIN Approved Mission 20-03-2015 COMPANY: Pharmaceu Each capsule ( MP/QA/025/15) ALPHA PHARM ticals. Contains:- Rs. 20,000/- AUSTRALIA Plot No. A- Minocycline As Per SRO 94, S.I.T.E. Hydrochloride 1 x 10’S Blister Minogen SUPER Equivalent to 100 mg Pack. MASS HIGHWA Minocycline Demanded price Rs. PHARMACEUTIC Y Antiboitic 200.0 ALS KARACHI USP Specification for DML No. 809 Pakistan. finished product attached (25-02- (Capsule, 2015) General Antibiotic section: DML No. 000809, dated 25- 02-2015)

(Capsule Cephalosporin section: DML No. 000809, dated 25-02-2015) year 272. M/s Mission Mixime capsules Form 5 Suprax Approved Pharmaceuti 20-03-2015 Sanofi-Aventis cals. Contains:- ( Plot No. A- Cefixime Trihydrate MP/QA/010/15) Cefiget 94, S.I.T.E. (USP) equivalent to Getz Pharma SUPER 400 mg Rs. 20,000/- HIGHWAY cephalosporin As Per SRO DML No. 809 attached KARACHI antibiotic (25-02-2015) Pakistan. USP Specification for 1 x 5’S Blister (Capsule Pack. Cephalospor finished product Demanded price in section: Rs. 325.0

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(Dry Powder Suspension, General Antibiotic section: DML No. 000809, dated 25-02- 2015) 273. M/s Mission Temefan Oral Form 5 Co-Artesiane Approved Pharmaceutic Suspension 20-03-2015 COMPANY: Dafra als. (Lumefantrine 90 ( Pharma Plot No. A- mg& MP/QA/029/15) BELGIUM 94, S.I.T.E. Artemether 15 mg/5 Rs. 20,000/- Artem plus By SUPER ml) As Per SRO Hilton HIGHWAY 60 ml Bottle Arceva by Sami KARACHI Each 5 ml Contains:- Pack. Qmetem plus By Pakistan. (Lumefantrine 90 Demanded price Bosch (Dry Powder mg&Artemether 15 Rs. 180.0 Suspension, mg General Anti Malaria Antibiotic USP Specification for section: finished product

274. M/s Mission Temefan DS Oral Form 5 Artem plus By Approved as USP Pharmaceutic Suspension 20-03-2015 Hilton salmous. als. (Lumefantrine180 ( Arceva by Sami KARACHI mg&Artemether 30 MP/QA/030/15) Qmetem plus By Pakistan. mg/5 ml) Rs. 20,000/- Bosch (Dry Powder Each 5 ml Contains:- As Per SRO DML No. 809 Suspension, (Lumefantrine180 60 ml Bottle attached (25-02- General mg&Artemether 30 Pack. 2015) Antibiotic mg Demanded price section: Anti Malaria Rs. 300.0 USP Specification for finished product 275. M/s Mission Miszin Oral Form 5 B-ZN Deferred for Pharmaceutic Suspension (Zinc 20 01-04-2015 BENHAM opinion/comments of als. mg/5 ml) ( PHARMACEUTIC WHO as per decision Plot No. A- MP/QA/031/15) ALS of the board in 250th 94, S.I.T.E. Each 5 ml Contains:- Rs. 20,000/- Zinkin plus By meeting. SUPER Zinc Sulphate As Per SRO semos Dosage HIGHWAY monohydrate 54.8 mg 60 ml Bottle Zincasa By recommendation KARACHI ,Equivalent to 20 mg Pack. Macter (UNICEF/ WHO): Pakistan. Zinc Demanded price Zinkitt By Tablets may contain (Dry Powder Anti-diarrhoeal & Rs. 75.0 either 10 or 20 mg of Lowitt Suspension, Zinc supplement zinc and the General USP Specification for DML No. 809 concentration of zinc Antibiotic finishedproduct attached (25-02- in oral solutions may section: DML 2015) be 10mg/5mL. No. 000809, Decisions about the dated 25-02- best strength to be 2015) used should depend on better adherence to treatment by patient, taking into

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consideration other issues as well, such as price, medicine delivery, and duration of treatment (10- or 14-day treatment). Preferably, in any given country, only one strength of tablets or oral solution should be available to avoid dosing errors. If 10-mg zinc tablets are chosen, it will mean that older children will have to take two tablets each day; if 20- mg zinc tablets are chosen, it will mean that for younger infants only half a tablet will be given each day and therefore tablets will have to be scored to facilitate this. With oral solutions, because it is difficult to accurately measure half a teaspoon of solution, it is recommended that oral solution of zinc contain 10mg of elemental zinc per 5 mL, that is to say per one teaspoon. It means that infants below 6 months of age will receive one teaspoon, while older children will need 2 teaspoons of oral solution per day. (Ref: UNICEF/ WHO)

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276. M/s Mission Elzee Oral Form 5 Azomax By Deferred for: Pharmaceutic Suspension 20-03-2015 Novartis  Source of the als. (Azithromycin ( Granules KARACHI Granules 200 mg) MP/QA/032/15) Zetro By Pakistan. Rs. 20,000/- Getz  GMP status of (Dry Powder Each 5 ml Contains:- As Per SRO source Suspension, Azithromycin 15 ml Bottle Plazo By General Dihydrate Pack. Platinum  If imported, Antibiotic ,Equivalent to 200 Demanded price submit difference section: mg Azithromycin . Rs. 223.0 in the fee as Macrolide prescribed USP Specification for

finished product

277. M/s Mission Klaron Oral Form 5 ADEL Deferred for: Pharmaceutic Suspension 20-03-2015 COMPANY:  Source of the als. (Clarithromycin ( SENOSIAIN Granules Plot No. A- Granules 125 mg) MP/QA/035/15) MEXICO 94, S.I.T.E. Each 5 ml Contains:- Rs. 20,000/- Klaracid By  GMP status of SUPER Clarithromycin As Per SRO Abbot source HIGHWAY (USP) 125 mg 60 ml Bottle DML No. 809 KARACHI Pack. attached (25-02- If imported, submit Pakistan. Anti Biotic Demanded price 2015) difference in the fee as (Dry Powder Rs. 314.55 prescribed Suspension, USP Specification for 25 ml Bottle General Pack. Antibiotic finished product Demanded price section: Rs. 157.0 Capsule , General section: DML No. 000809, dated 25-02-2015) 278. M/s Mission Tranex Capsules Form 5 AMCHAFI Approved Pharmaceuticals. (Tranexamic acid 500 mg) 01-04-2015 BRIN Plot No. A-94, Capsules ( COMPAN S.I.T.E. SUPER Contains:- MP/QA/047/1 Y: HIGHWAY Each capsule : 5) ROTTAPH KARACHI Tranexamic acid 500 mg Rs. 20,000/- ARM Pakistan. As Per SRO SPAIN (Capsule , General Antifibrinolytic agent,Anti- 10’s x 2 Maxna section: DML No. Plasminic; Hemostatic Blister Pack. By AGP 000809, dated 25- Demanded Traxyl 02-2015) B.P Specification for finished price Rs. By OBM product 250.0 pharma Xamig By Highnoon

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279. M/s Mission Tranex Capsules Form 5 AMCHAFI Pharmaceuticals. (Tranexamic acid 250 mg) 01-04-2015 BRIN Approved Plot No. A-94, Capsules ( COMPAN S.I.T.E. SUPER Contains:- MP/QA/046/1 Y: HIGHWAY Each capsule : 5) ROTTAPH KARACHI Tranexamic acid 250 mg Rs. 20,000/- ARM Pakistan. As Per SRO SPAIN (Capsule , General Antifibrinolytic agent,Anti- 10’s x 2 Maxna section: DML No. Plasminic; Hemostatic Blister Pack. By AGP 000809, dated 25- Demanded Traxyl 02-2015) B.P Specification for finished price Rs. By product 130.0 OB M pharma

(Liquid Syrup , General section: DML No. 000809, dated 25-02-2015) 280. M/s Mission Alerzin Syrup Form 5 Zyrtec Deferred for correction Pharmaceuticals. ( Cetirizine 5 mg/5 ml ) 01-04-2015 By of composition of the Plot No. A-94, SYRUP ( GSK product as product is S.I.T.E. SUPER Contains:- MP/QA/048/1 Gixer By approved as HIGHWAY Each 5 ML : 5) Barrett Cetirizine KARACHI Cetirizine Rs. 20,000/- Hodgson hydrochloride 5mg in Pakistan. dihydrochlorideEquivalent to As Per SRO Pakistan MHRA whereas (Liquid Syrup , 5 mg Cetirizine 60 ML Bottle Ronex applied formulation is General section: Antihistaminic agent pack. By Cetirizine DML No. 000809, B.P Specification for finished Demanded Hilton dihydrochloride dated 25-02-2015) product price Rs. 45.0 pharma Equivalent to 5 mg Zanlan Cetirizine By Novartis Pharma 281. M/s Mission Iromax Syrup Form 5 Ferretts Approved Pharmaceuticals. SYRUP 01-04-2015 IPS Plot No. A-94, ( USA S.I.T.E. SUPER Each 15 ML contains: MP/QA/049/1 HIGHWAY Iron protein succinylate 800 5) Iropal By KARACHI mg /15 Rs. 20,000/- Pharmix Pakistan. Anti Anaemic As Per SRO (Liquid Syrup , Mission Specification for 120 ML General section: finished product Bottle pack. DML No. 000809, Demanded dated 25-02-2015) price Rs. 180.0 282. M/s Mission Mismol Suspension Form 5 TYLENOL Approved Pharmaceuticals. SUSPENSION 01-04-2015 MC NEIL Plot No. A-94, ( CONSUM S.I.T.E. SUPER Each 5 ML Contains:- MP/QA/050/1 ER HIGHWAY Paracetamol 120 mg 5) HEALTH KARACHI Analgesic Rs. 20,000/- CARE,

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Pakistan. As Per SRO USA (Liquid Syrup , B.P Specification for finished 60 ML Bottle Calpol, General section: product pack. Panadol By DML No. 000809, Demanded Glaxo dated 25-02-2015) price Rs. 25.0 smithkline Febrol By Barrett Hodgson 283. M/s Mission Muterol Syrup Form 5 APO- Approved Pharmaceuticals. SYRUP 01-04-2015 SALVENT Plot No. A-94, Each 5 ML contains : ( COMPAN S.I.T.E. SUPER Albuterol Sulfate (USP) MP/QA/051/1 Y: HIGHWAY equivalent to 2 mg Albuterol 5) APOTEX KARACHI Rs. 20,000/- CANADA Pakistan. Beta2-adrenergic As Per SRO Ventolin (Liquid Syrup , bronchodilator 60 ML Bottle Syrup General section: USP Specification for pack. GLAXOS DML No. 000809, finished product Demanded MIHKLIN dated 25-02-2015) price Rs. 25.0 E

284. M/s Mission Maxton Syrup Form 5 ASKLAMI Pharmaceuticals. SYRUP 01-04-2015 N Deferred for vitamin Plot No. A-94, Each 5 ML Contains:- ( ASKLEPI Policy S.I.T.E. SUPER Ferric ammonium citrate MP/QA/053/1 OS HIGHWAY (BPC) 45 mg, 5) REMEDIE KARACHI Vitamin B12 (BP) 18mcg, Rs. 20,000/- S Pakistan. Panthenol (USP) 1.65 mg, As Per SRO Vitaglobin (Liquid Syrup , Nicotinamide (BP)1 mg, 250 ML By Swiss General section: Pyridoxine HCl (BP) 2 mg, Bottle pack. Pharma DML No. 000809, Folic acid (USP) 0.5 mg& Demanded Amroton dated 25-02-2015) Thiamine HCl (BP) 1 mg price By Amros Multivitamin with IRON Rs.120.0 Pharma USP & B.P Specification for finished product 120 ML Bottle pack. Demanded price Rs. 70.0

285. M/s Mission Mislor Syrup Form 5 AEROTIN Approved Pharmaceuticals. (Loratadine 5mg) 01-04-2015 A Plot No. A-94, SYRUP ( COMPAN S.I.T.E. SUPER Contains:- MP/QA/055/1 Y: RAFFO HIGHWAY Each 5 ML : 5) ARGENTI KARACHI Loratadine (USP) 5mg Rs. 20,000/- NA Pakistan. Oral non-sedating H1- As Per SRO Victrin

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(Liquid Syrup , blocker By Barrett General section: USP Specification for 60 ML Bottle Hodgson DML No. 000809, finished product pack. Softin dated 25-02-2015) Demanded By price Rs. 55.0 Werrick 286. M/s Mission Mismol Plus Suspension Form 5 TYLENOL Approved Pharmaceuticals. SUSPENSION 01-04-2015 MC NEIL Plot No. A-94, ( CONSUM S.I.T.E. SUPER Each 5 ML : MP/QA/056/1 ER HIGHWAY Paracetamol (BP) 250 mg 5) HEALTH KARACHI Analgesic Rs. 20,000/- CARE Pakistan. B.P Specification for finished As Per SRO USA (Liquid Syrup , product 60 ML Bottle Calpol - General section: pack. 6plus By DML No. 000809, Demanded Glaxo dated 25-02-2015) price Rs. 35.0 smithkline

287. M/s Mission Misofenac Suspension Form 5 NUROFEN Approved Pharmaceuticals. SUSPENSION 01-04-2015 RECKITT Plot No. A-94, ( BENCKIS S.I.T.E. SUPER Each 5 ML Contains:- MP/QA/059/1 ER HIGHWAY Ibuprofen (BP)100 mg, 5) KARACHI Pseudoephedrine HCl(BP) Rs. 20,000/- Arinac Pakistan. 15 mg As Per SRO Suspension (Liquid Syrup , Anti bronchospasm By General section: B.P Specification for finished 90 ML Bottle Abbott DML No. 000809, product pack. laboratories dated 25-02-2015) Demanded price Rs. 39.0

288. M/s Mission Miroton Syrup Form 5 Deurali- Pharmaceuticals. SYRUP 15-04-2015 Janta Approved Plot No. A-94, Each 5 ML Contains:- ( pharmaceut S.I.T.E. SUPER Iron –III –Hydroxide MP/QA/100/1 icals HIGHWAY polymaltose complex, 5) Bisleri KARACHI equivalent to Elemental Iron Rs. 20,000/- BySami Pakistan. ---- 50 mg As Per SRO Apofer (Liquid Syrup , Anti Anaemic 60 ML & 120 BY General section: Mission Specification for ml Bottle Platinum DML No. 000809, finished product pack. Bioiron dated 25-02-2015) Demanded price 60 ml: By Rs. 70.0 Bio-Lab 120 ml: Rs 120.0 Chewron BY Medisure

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Liquid InjectionAmpoule section: DML No. 000809, dated 25-02-2015) 289. M/s Mission Diafac Injection Form 5 Approved Pharmaceuticals. (Diclofenac sodium 75 REF # ADOFEED Plot No. A-94, mg/3ml) MP/QA/098/1 LEAD Condition will be S.I.T.E. SUPER Each 3 ml contains:- 5 CHEMICA mentioned in HIGHWAY Diclofenac Sodium U.S.P --- Dated: 01-04 L registration letter that KARACHI - 75mg -2015 JAPAN firm will Pakistan. Analgesics, antipyretics, Rs. 20,000/- VoltralNov purchase and perform Liquid Injection NSAID As Per SRO artis installation and Ampoule section: USP Specification for Voren operational DML No. 000809, finished product Pack Size Asian qualifications of TOC dated 25-02-2015) 3 ml x5’s Continental analyser and liquid Proposed Orthofanac particle Price Bosch counter in six months Rs. 137.00 DML No. time. 000809 attached (25-02-15) 290. M/s Mission BUPICALM Injection Form 5 MARCAIN Pharmaceuticals. (Bupivacaine HCl 7.5 mg) REF # ABBOTT Approved Plot No. A-94, Each ml contains MP/QA/099/1 HEALTH S.I.T.E. SUPER Bupivacaine 5 CARE Condition will be HIGHWAY HClmonohydrate equivalent Dated: 01-04- USA mentioned in KARACHI to Bupivacaine HCl -----7.5 2015 registration letter that Pakistan. mg local anesthesia Rs. 20,000/- Bucane firm will (Liquid Injection USP Specification for As Per SRO By Oophth purchase and perform Ampoule section: finished product Pack Size: pharma installation and DML No. 000809, 2ml x 10 Glocain operational dated 25-02-2015) Demanded By Global qualifications of TOC Price Rs. 300. Nervlok analyser and liquid By Surge particle Lab counter in six months time.

291. M/s Mission Unicain Injection Form 5 NAROPIN Deferred for Pharmaceuticals. Each ml contains : REF # Fresenius confirmation of me-too Plot No. A-94, Ropivacaine HCl (USP) ----- MP/QA/066/1 Kabi status. S.I.T.E. SUPER 2 mg 5 USA HIGHWAY Dated: 01-04- Ropicain KARACHI local or regional anesthesia 2015 injection Pakistan. USP Specification for Rs. 20,000/- By Lahore (Liquid Injection finished product As Per SRO Pharma Ampoule section: Pack Size: DML No. DML No. 000809, 10ml x 1 000809 dated 25-02-2015) Packed attached Demanded (25-02- Price Rs.90.0 2015)

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292. M/s Mission Unicain Injection Form 5 NAROPIN Pharmaceuticals. (Ropivacaine HCl,5 mg/ml) REF # Fresenius Approved Plot No. A-94, Eachml contains : MP/QA/067/1 Kabi S.I.T.E. SUPER Ropivacaine HCl (USP) ----- 5 USA Condition will be HIGHWAY ------5 mg Dated: 01-04- Ropicain mentioned in KARACHI local or regional anesthesia 2015 injection registration letter that Pakistan. USP Specification for Rs. 20,000/- By Lahore firm will (Liquid Injection finished product As Per SRO Pharma purchase and perform Ampoule section: Pack Size: DML No. installation and DML No. 000809, 10ml x 1 000809 operational dated 25-02-2015) Packed attached qualifications of TOC Demanded (25-02- analyser and liquid Price Rs. 2015) particle 180.0 Hold counter in six months time. 293. M/s Mission Misroplex , Multi B Complex Form 5 Bejectal Deferred for vitamin Pharmaceuticals. injection REF # Injection Policy Plot No. A-94, Each ml contains : MP/QA/064/1 By Abbott S.I.T.E. SUPER Thiamine Hcl (BP) 10 mg 5 HIGHWAY Riboflavin 5 phosphate(BP) Dated: 01-04- KARACHI 2 mg 2015 Pakistan. Pyridoxine HCl (BP) 5 mg Rs. 20,000/- (Liquid Injection Nicotinamide (BP) 75 mg As Per SRO Ampoule section: Dexpenthenol (USP) 5 mg Pack Size: DML No. 000809, Multi B Complexl 1ml x 10 dated 25-02-2015) BP & USP Specification for Packed finished product Demanded Price Rs. 50.09

294. M/s Mission Misvinate Injection Form 5 AMOSYT Approved Pharmaceuticals. (Dimenhydrinate 50mg) REF # COMPAN Plot No. A-94, Each ml contains : MP/QA/065/1 Y: Condition will be S.I.T.E. SUPER Dimenhydrinate(USP) ------5 BIOGLAN mentioned in HIGHWAY 50mg Dated: 01-04- SWEDEN registration letter that KARACHI Antiemetics 2015 Gravinate firm will Pakistan. USP Specification for Rs. 20,000/- By Searle purchase and perform (Liquid Injection finished product As Per SRO Pakistan installation and Ampoule section: Pack Size: operational DML No. 000809, 1ml x 25 qualifications of TOC dated 25-02-2015) Packed analyser and liquid Demanded particle Price counter in six months Rs.159.50 time.

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295. M/s Mission Unifer Injection Form 5 VENOFER Approved Pharmaceuticals. Each ml contains : REF # Vifor Plot No. A-94, Iron Sucrose, equivalent to MP/QA/068/1 (Internation Condition will be S.I.T.E. SUPER elemental Iron 20mg/ml) 5 al) Inc., mentioned in HIGHWAY ATI-ANEMIA Dated: 01-04- Switzerland registration letter that KARACHI USP Specification for 2015 Venofer firm will Pakistan. finished product Rs. 20,000/- By RG purchase and perform (Liquid Injection As Per SRO Pharmaceut installation and Ampoule section: Pack Size: ica operational DML No. 000809, 5ml x 5 qualifications of TOC dated 25-02-2015) Packed analyser and liquid Demanded particle Price Rs. counter in six months 2000.0 time.

296. M/s Mission Misadol Injection Form 5 Kingdom; Pharmaceuticals. Each 2ml contains : REF # Janssen, Approved Plot No. A-94, Tramadol HCl(USP) 100 mg MP/QA/072/1 Mexico; S.I.T.E. SUPER Analgesic 5 Janssen- Condition will be HIGHWAY USP Specification for Dated: 01-04- Cilag mentioned in KARACHI finished product 2015 Ramol registration letter that Pakistan. Rs. 20,000/- Macter firm will (Liquid Injection As Per SRO Merlon purchase and perform Ampoule section: Pack Size: AGP installation and DML No. 000809, 2ml x Tramal operational dated 25-02-2015) 5packed Searle qualifications of TOC Demanded Tamadol analyser and liquid Price Rs. particle 167.35 Highnoon counter in six months time. 297. M/s Mission Miscobal injection Form 5 Elgin By Approved Pharmaceuticals. Each ml contains : REF # Novartis Plot No. A-94, Mecobalamin 500mcg MP/QA/073/1 Hicobal Condition will be S.I.T.E. SUPER Co – enzyme type vitamin 5 Himont mentioned in HIGHWAY B12 Dated: 01-04- Methycoba registration letter that KARACHI MISSION Specification for 2015 l firm will Pakistan. finished product Rs. 20,000/- Hilton purchase and perform (Liquid Injection As Per SRO Vitaxon installation and Ampoule section: Pack Size: CCL operational DML No. 000809, 1ml x 10 qualifications of TOC dated 25-02-2015) packed analyser and liquid Demanded particle Price Rs. counter in six months 936.07 time.

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298. M/s Mission MISRONIC Injection Form 5 ZOLEDRO Approved Pharmaceuticals. REF # NIC ACID Plot No. A-94, Each ml contains:- MP/QA/102/1 Fresenius Condition will be S.I.T.E. SUPER 0.8528 mg Zoledronic acid 5 Kabi USA mentioned in HIGHWAY monohydrate equivalent to Dated: 20-04 Zometa registration letter that KARACHI 0.8 mg Zoledronic acid USP. -2015 By firm will Pakistan. Bisphosphonate, Drugs Rs. 20,000/- Novartis purchase and perform Liquid Injection affecting bone metabolism As Per SRO Zoldria installation and Ampoule section: USP Specification for Pack Size A.J.Mirza operational DML No. 000809, finished product 5 ml x1’s Zoldic qualifications of TOC dated 25-02-2015) Proposed analyser and liquid Price CCL particle Rs. 16,000 Kedronico counter in six months Oncogene time.

299. M/s Mission MISKET Injection Form 5 Ketamine Approved Pharmaceuticals. REF # HCl Only one volume is Plot No. A-94, Each ml contains:- MP/QA/114/1 Ben Venue allowed as per S.I.T.E. SUPER 57.5 mg Ketamine HCl 5 laboratories procedure of HIGHWAY equivalent to Ketamine base Dated: 01-06 , Inc, registration board and KARACHI 50 mg -2015 Bedford,O Chairman, RB will Pakistan. General anaesthetic Rs. 20,000/- H permit issuance of Liquid Injection Mission Specification for As Per SRO UK registratyion letter with Ampoule section: finished product Pack Size that volume. DML No. 000809, 5 ml x5’s KETASOL dated 25-02-2015) Proposed INDUS Condition will be Price PHARMA mentioned in Rs. 325.0 registration letter that 10 ml= 125.0 DML No. firm will Rs 000809 purchase and perform attached installation and (25-02- operational 2015) qualifications of TOC analyser and liquid particle counter in six months time

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Tablet General section: DML No. 000809, dated 25-02-2015) 300. M/s Mission Diafac. Form 5 ADOFEED Approved with Pharmaceutical Tablets REF # LEAD change of brand s. Each enteric coated tablet MP/QA/096/1 CHEMICAL name Plot No. A-94, contains:- 5Dated: 01-04 JAPAN S.I.T.E. Diclofenac Sodium U.S.P ---- -2015 VoltralNovart SUPER 50mg Rs. 20,000/- is HIGHWAY Analgesics, antipyretics, As Per SRO Voren Asian KARACHI NSAID 2 x10’sBlister Continent Pakistan. USP Specification for pack Orthofanac Tablet General finished product Demanded Bosch section: DML price: No. 000809, Rs. 115.92 dated 25-02- 2015) 301. Alerzin Tablet Form 5 Zanlan By Deferred for correction M/S Mission (Cetirizine HCL 10 mg) REF # Novartis of composition of the Pharmaceutical Each film coated tablet MP/QA/078/1 Zyrtec product as product is s. contains:Cetrizine HClB.P 5 AGP (PVT.) approved as Plot No. A-94, equivalent to Cetirizine.10 mg Dated: 01-04- Actilix-ctz Cetirizine S.I.T.E. Antihistaminic agent. 2015 hydrochloride 5mg in Glaxo Smith SUPER B.P Specification for finished Rs. 20,000/- MHRA whereas HIGHWAY product As Per SRO kline applied formulation is KARACHI Cetirizine Baydal Pakistan. Pack Size1x dihydrochloride Tablet General 10’ Blister Bayer Equivalent to 5 mg section: Pack Cetirizine Schering DMLNo. Demanded 000809, dated Price Gixer 25-02-2015 Rs.40.00 Barrett

Hodson 302. M/S Mission Imuncept tablet Form 5 Deferred for decision Pharmaceutical (Mycofenolate Mofetil 500 REF # CELL CEPT regarding ROCHE s. mg) MP/QA/087/1 manufacturing Plot No. A-94, 5 requirements for S.I.T.E. Each film coated tablet Dated: 01-04- Cellcept immunosuppressant SUPER contains: Mycofenolate 2015 Roche drugs. HIGHWAY MofetilU.S.P- 500 mg Rs. 20,000/- Imuxgen KARACHI immunosupressant, As Per SRO Pakistan. USP Specification for Feroz sons Tablet General finished product Pack Size section: 5x10’ Blister DMLNo. Pack 000809, dated Demanded 25-02-2015 Price Rs. 8000.00

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303. Rena plus tablet Form 5 RENAPLEX M/S Mission (Multivitamin with minerals) REF # NEPHRO Deferred for vitamin Pharmaceutical Each film coated tablet MP/QA/093/1 TECH Policy s. contains:Thiamine HCl (B.P) 5 USA Plot No. A-94, 1.5 mg , Riboflavin (B.P) 1.7 Dated: 01-04- Enervit S.I.T.E. mgPyridoxine HCl (B.P)10 2015 Himont SUPER mgVitamin C (B.P) 60 mg, Rs. 20,000/- DML No. HIGHWAY Nicotinamide (B.P) 20mg As Per SRO 000809 KARACHI VitaminB12 (B.P) 6 mcg, attached (25- Pakistan. Folic acid (B.P) 0.8 mg Pack Size 100 02-2015) Tablet General ,Panthenol (U.S.P)10 mg, tablet Bottle section: Biotin (U.S.P) 300 mcg and Pack DMLNo. Zinc g luconate(U.S.P)12.5mg Proposed 000809, dated Dietary Supplement Price Rs. 25-02-2015 B.P / USP Specification for 515.00 finished product 304. Restore 10 mg tablet Form 5 Approved M/S Mission Each film coated tablet REF # CRESTOR Pharmaceutical contains: Rosuvastatin MP/QA/095/1 s. CalciumU.S.P equivalent to 5 AstraZeneca, Plot No. A-94, Rosuvastatin- 10 mg Dated: 01-04- USA S.I.T.E. Lipid-lowering agent 2015 SUPER USP Specification for Rs. 20,000/- Rosutrol HIGHWAY finished product As Per SRO Pfizer KARACHI Pakistan. Pack Rova Tablet General Size1x10’ Bosch section: Blister Pack Proposed X-Plended Price Pharm Evo Rs. 200.00 305. M/S Mission Restore 20mgtablet Form 5 CRESTOR Approved Pharmaceutical (Rosuvastatin calcium ) REF # AstraZeneca, s. Each film coated tablet MP/QA/079/1 USA Plot No. A-94, contains: Rosuvastatin 5 S.I.T.E. CalciumU.S.P equivalent to Dated: 01-04- Rosutrol SUPER Rosuvastatin- 20 mg 2015 Pfizer HIGHWAY Lipid-lowering agent Rs. 20,000/- Rova KARACHI USP Specification for As Per SRO Bosch Pakistan. finished product Tablet General Pack X-Plended section: Size1x10’ Pharm Evo DMLNo. Blister Pack 000809, dated Proposed 25-02-2015 Price Rs. 400.00

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306. M/s Mission MIROTON PLUS Form 5 Ferofolic Approved Pharmaceutical CHEWABLE TABLET REF # syrup s. MP/QA/101/1 Deurali-Janta Plot No. A-94, 5Dated: 15-04 pharmaceutica S.I.T.E. Each chewable tablet -2015 ls SUPER contains:- Rs. 20,000/- Bisleri HIGHWAY Iron –III –hydroxide As Per SRO Sami KARACHI polymaltose complex 1 x10’s Pakistan. equivalent to elemental iron Blister pack Apofer Tablet General 100 mg & Folic acid 0.35 mg Demanded Platinum section: Anti Anaemic price: 70.0 Rs Mission &USP Specification Bioiron for finished product Bio-Lab

307. M/s Mission Form 5 Plevix Approved with change Pharmaceutical E MISPLATE FILM REF # Bristol-Myers of brand name s. COATED TABLET MP/QA/089/1 Squibb / Plot No. A-94, 5Dated: 15-04 Sanofi S.I.T.E. -2015 Lowplat SUPER Each film coated tablet Rs. 20,000/- Pharm Evo HIGHWAY contains:- As Per SRO Clogrel KARACHI 98.0 mg of Clopidogrel 1 x10’s Pharmatec Pakistan. bisulfate Blister pack Clotnil Tablet General ( USP) which is the molar Demanded section: equivalent of 75 mg of price: 140.0 Barrett Clopidogrel base Rs Hodgson Anti Platelet USP Specification for finished product ( Dialysis solution section: DML No. 000809, dated 25-02-2015) 308. M/s Mission Renal Cure Form 5 RENAL Deferred for Pharmaceutical (Salt Concentrate Solution) 20-03-2015 PURE comparison of s. ( composition with Plot No. A-94, Composition:Part A( liquid MP/QA/022/1 ROCK WELL already registered drug S.I.T.E. Form) 5) USA SUPER Sodium 139±15%mEq/L HIGHWAY Potassium 2.0±15%mEq/L Rs. 20,000/- Renacon KARACHI Calcium 2.5±15%mEq/L As Per SRO Medi Pak Pakistan. Chloride 106±15%mEq/L DML No. 809 (Liquid Acetic acid 4±15%mEq/L For Single attached (25- Dialysis Dextrose 200±15 mgm% Dialysis of 4 02-2015) solution PART B (Liquid form) hrs session section: DML Sodium 59 mEq/L (4 litre A & No. 000809, Chloride 20 mEq/L 6.7 litres B) dated 25-02- Bicarbonate 35-39 mEq/L price= 2015) Rs595/Dialysis Set Packing

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Dialysis salt Part A liquid 4,12 & 20 Mission , BP & USP litre Specification for finished product. Part B Liquid 6.7, 20 & 33 Litres (Powder for Dialysis section: DML No. 000809, dated 25-02-2015) 309. M/s Mission Renal Cure ( Dialysate Form 5 RENAL Deferred for Pharmaceutical Concentrate Powder) 20-03-2015 PURE comparison of s. Composition:Part A ( composition with Plot No. A-94, Sodium 139±20%mEq/L MP/QA/023/1 ROCK WELL already registered drug S.I.T.E. Potassium 2.0±20%mEq/L 5) USA SUPER Calcium 2.5±20%mEq/L Rs. 20,000/- Renacon HIGHWAY Chloride 106±20%mEq/L As Per SRO Medi Pak KARACHI Acetic acid 4±20%mEq/L DML No. 809 Pakistan. Dextrose 200±20 mgm% For Single attached (25- (Powder for Part B dialysis , 02-2015) Dialysis PART B (Powder form) 4 hrs session section: DML Cartilage & pouch with Part A No. 000809, Bicarbonate 35-39 mEq/L (Equivalent to dated 25-02- 4 L) 2015) Dialysis salt and part B (Equivalent to Mission , BP & USP 6.7 L)= Specification for finished Price=595 product Rs/dialysis Set Packs sizes Part A 1040g, 3120 g &24.626 kg pouches Part B 597g,1790g & 8.42 kg in pouches. Part B cartilage in 650g & 750 g

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(New License approved in 242nd Meeting of CLB)

310. M/s Neocomb Tablet Form 5D Vimovo Tablets Deferred for Jenner 375/20mg Dairy No. 924 UK  Stability Data as Pharma, Each double coreTablet dated 30.09.15 MHRA per guidelines Lahore contains: Rs:50,000 dated approved by the Naproxen (as enteric 29.09.2015 board in 251st coated inner As per SRO meeting. core)……..375mg 10’s Esomeprazole (as MagnesiumTrihydrate as film coated outer core)………20mg NSAIDs+PPI (Manufacturer specification) 311. -do- Derifen Tablets 7.5mg Form 5D Enablex Tablets Deferred for Each extended release Dairy No. 915 by Novartis  Stability Data as tablet contains Darifenacin dated 30.09.15 Pharma per guidelines (as bromide)………7.5mg Rs:50,000 dated Swizerland approved by the Selective muscarinic M3 29.09.2015 (Need to be board in 251st receptor antagonist As per SRO confirmed) meeting. In house specs. Alu foil, PVC 10’s 312. -do- Derifen Tablets 15mg Form 5D Enablex Tablets Deferred for Each extended release Dairy No. 922 by Novartis  Stability Data as tablet contains Darifenacin dated 30.09.15 Pharma per guidelines (as bromide)………15mg Rs:50,000 dated Swizerland approved by the Selective muscarinic M3 29.09.2015 (Need to be board in 251st receptor antagonist As per SRO confirmed) meeting. In house specs. Alu foil, PVC 10’s 313. -do- Plexodol Tablets 50mg Form 5D Palexia Tablets Deferred for Each film coated tablet Dairy No. 910 by Grunenthal  Stability Data as contains: Tapentadol (as dated 30.09.15 Ltd. UK per guidelines HCl)………50mg Rs:50,000 dated USFDA approved by the Analgesic, Opiods 29.09.2015 board in 251st In house specs. As per SRO meeting. Alu foil, PVC 10’s 314. -do- Plexodol Tablets 50mg Form 5D Palexia Tablets Deferred for Each film coated tablet Dairy No. 913 by Grunenthal  Stability Data as contains: Tapentadol (as dated 30.09.15 Ltd. UK per guidelines HCl)………75mg Rs:50,000 dated USFDA approved by the Analgesic, Opiods 29.09.2015 board in 251st In house specs. As per SRO meeting. Alu foil, PVC 10’s 315. -do- Moxifid Tablets 200mg Form 5D Dificid tablets Deferred for Each film coated tablet Dairy No. 917 By Optimer  Stability Data as contains: dated 30.09.15 Pharmaceuticals, per guidelines Fidaxomicin………200mg Rs:50,000 dated Inc. USA approved by the

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Macrolide Antibiotics, 29.09.2015 USFDA board in 251st Antidiarrhoeals, intestinal As per SRO meeting. anti inflammatory/ anti- Alu foil, PVC infective agent 10’s In house specs.

316. -do- Rifamin Tablets 200mg Form 5 Xifaxan tablets Approved Each film coated tablet Dairy No. 916 by m/s Salix contains: dated 30.09.15 Pharmaceuticals, Rifaximin………200mg Rs:20,000 dated USA Non Aminoglycoside 29.09.2015 (USFDA) Semisynthetic, Non As per SRO Foxamine Tabets systemic antibiotic Alu foil, PVC 200mg by CCl In house specs. 10’s Pharma

317. -do- Rifamin Tablets 550mg Form 5 Xifaxan tablets Approved Each film coated tablet Dairy No. 908 by m/s Salix contains: dated 30.09.15 Pharmaceuticals, Rifaximin………550mg Rs:20,000 dated USA Non Aminoglycoside 29.09.2015 USFDA Semisynthetic, Non As per SRO Foxamine Tabets systemic antibiotic Alu foil, PVC 550mg by CCl In house specs. 10’s Pharma

318. -do- Febuxo Tablets 40mg Form 5 Uloric Tablets by Approved Each film coated tablet Dairy No. 904 m/s Takeda contains: Febuxostat dated 30.09.15 Pharma USA, INN………40mg Rs:20,000 dated USFDA Anti gout preparation 29.09.2015 Uring Tablets by inhibiting uric acid As per SRO m/s Getz Pharma In house specs. Alu foil, PVC 20’s 319. -do- Catadol Tablets Form 5 Tramacet Approved 37.5/325mg Dairy No. 909 37.5/325mg Each film coated tablet dated 30.09.15 Tablets by contains: Tramadol Rs:20,000 dated Grunenthal Ltd, HCl……37.5mg 29.09.2015 Uk Paracetamol………325mg As per SRO MHRA NSAID, Opoid analgesic Alu foil, PVC Tramal Plus USP specs. 20’s Tablets by m/s Searle Pakistan

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Case No. 08 REVIEW OF FORMULATION-M/S ARSON PHARMA, LAHORE.

Registration Board in its 202nd meeting approved the application of M/s Arsons Pharmaceuticals Industries (Pvt.) Ltd; Lahore for their product “Arsopore” (Permeable Non- woven Surgical Synthetic Adhesive Tape) held on 8-th December, 2006. M/s Arsons Pharmaceuticals Industries (Pvt.) Ltd; Lahore have requested for issuance of registration letter. At the time of issuance of registration letter it was observed that product is just adhesive tape without medicament. It can also be used for other purpose. Registration Board is requested to re- considered the case and referred the case to expert review committee.

Name and Brand Name Type of Form Remarks on the Remarks by address of (Proprietary formulation (if Evaluator manufacturer / name + Dosage Initial date, diary any) including Applicant Form + Strength) International Fee including status in stringent Composition differential fee drug regulatory agencies / Pharmacological Demanded Price / authorities Group Pack size Me-too status Finished product Specification GMP status as depicted in latest inspection report (with date) by the Evaluator M/s Arsons Arsopore Tape Form-5 International International Pharmaceuticals, Permeable Non- Rs.8,000/- availability not availability not Lahore woven Surgical Rs.12,000/- confirmed. confirmed. Synthetic 1.25cmx3.5cm Adhesive Tape. 1.25cmx4m (B.P) 1.25cmx4.5m Me-too:Nichipore 1.25cmx5m by M/s Uniferoz Rs.115/- Karachi. Rs.131.10/- Rs.148.35/- Rs.164.50/-

Decision: Case was deferred for opinion/ comments of Medical Devices Division.

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B. New Cases: Case No. 1: Grant of Registration to new licence Evaluator I S/N Name and Brand Name Type of International Remarks / Observations address of (Proprietary Form status in manufacturer name + Dosage Initial date, stringent / Applicant Form + diary regulatory Strength) Fee including agencies Composition differential Pharmacologic fee Me-too status al Group Demanded Finished Price / Pack GMP status as product size depicted in Specification inspection report (dated)

01. M/s Jawa Jafotax Form-5 FDA Pharmaceutic Injection 1gm 19-10-2015 Cefotaxime Approved als, (Pvt) Ltd, Each vial diary #1441 Sodium as base 112/10, contains:- Rs.20000 1gm by M/s Quaid-e- Cefotaxime (as As per SRO Fresenus Kabi Azam Cefotaxime Industrial Sodium)B.P….. Claforan 1g by Estate, Kot ….. 1g M/s Sanofi Lakhpat, Cephalosporin Lahore. B.P Dry Powder Specifications Injectables (Cephalospori n) 02. -do- Jafotax Form-5 FDA Injection 500mg 19-10-2015 Cefotaxime Approved Each vial diary #1476 Sodium as base contains:- Rs.20000 500gm by M/s Cefotaxime (as As per SRO Fresenus Kabi Cefotaxime Sodium)B.P….. Claforan 500mg ….. 500mg by M/s Sanofi Cephalosporin B.P Specifications 03. -do- Jafotax Form-5 UK. Claforan Injection 250gm 19-10-2015 Injection 250mg Approved Each vial diary #1464 as base by M/s contains:- Rs.20000 Sanofi Cefotaxime (as As per SRO Cefotaxime Claforan 250mg

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Sodium)B.P….. by M/s Sanofi ….. 250mg Cephalosporin B.P Specifications 04. -do- Track Injection Form-5 FDA. Rocephin 1gm 19-10-2015 Injection 1gm Approved as IM Each vial diary #1472 by M/s contains:- Rs.20000 Hoffmann La Ceftriaxone (as As per SRO Roche Ceftriaxone Sodium)B.P….. Rocephin 1g by ….. 1gm M/s Martin dow Cephalosporin B.P Specifications 05. -do- Track Injection Form-5 FDA. Rocephin Approved as IV 500mg 19-10-2015 Injection 500mg Each vial diary #1440 by M/s contains:- Rs.20000 Hoffmann La Ceftriaxone (as As per SRO Roche Ceftriaxone Sodium)B.P….. Rocephin ….. 500mg 500mg by M/s Cephalosporin Martin dow B.P Specifications 06. -do- Track Injection Form-5 FDA. Rocephin Approved as IM 250mg 19-10-2015 Injection 250mg Each vial diary #1478 by M/s contains:- Rs.20000 Hoffmann La Ceftriaxone (as As per SRO Roche Ceftriaxone Sodium)B.P….. Rocephin ….. 250mg 250mg by M/s Cephalosporin Martin dow B.P Specifications 07. -do- Darphin Form-5 FDA Velosef Deferred for confirmation of Injection 500mg 19-10-2015 Injection 500mg approval status in reference Each vial diary #1436 by M/s regulatory authorities. Moreover, contains:- Rs.20000 Apothecon product has been discontinued by Cephradine….. As per SRO USFDA. ….. 500mg Veloef Injection Cephalosporin 500mg by M/s B.P GSK Specifications

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08. -do- Darphin Form-5 FDA Velosef Deferred for confirmation of Injection 1gm 19-10-2015 Injection 1gm approval status in reference Each vial diary #1475 by M/s regulatory authorities. Moreover, contains:- Rs.20000 Apothecon product has been discontinued by Cephradine….. As per SRO USFDA. ….. 1gm Veloef Injection Cephalosporin 1gm by M/s B.P GSK Specifications 09. -do- Jewpime Form-5 FDA.Cefepime Approved Injection 500mg 19-10-2015 HCl as base Each vial diary #1460 500mg by M/s contains:- Rs.20000 Hospira Cefepime as As per SRO HCl…..….. Maxipime 500mg Injection 500mg Cephalosporin by M/s GSK U.S.P Specifications 10. -do- Jewpime Form-5 FDA.Cefepime Approved Injection 1gm 19-10-2015 HCl as base Each vial diary #1438 1gm by M/s contains:- Rs.20000 Hospira Cefepime as As per SRO HCl…..….. Maxipime 1gm Injection 1g by Cephalosporin M/s GSK U.S.P Specifications 11. -do- Novat-S Form-5 Deferred for External Solution 19-10-2015  Calculations are not provided in Preparation Each ml diary #1461 Provate Lotion salt & base form. (Gen) Section contains:- Rs.20000 by M/s Saffron  Address provided at form 5 is Betamethasone As per Pharma incomplete. (as SRO/20ml &  Internationally availability is not Dipropionate)… 60ml provided by the firm. ..….. 0.5mg  Manufacturing method is Salicylic incomplete as the firm has not Acid……..20m mentioned temperature for g manufacturing. Corticosteroid+  Raw material specifications are Keratolytic not provided. agent  The firm has mentioned the B.P reference of B.P but the Specifications formulation is not present in B.P. require to be submitted.

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12. -do- Novat Lotion Form-5 UK Betnovate Approved. Each 100ml 19-10-2015 Lotion by M/s Condition will be mentioned in contains:- diary #1462 GSK registration letter that firm will Betamethasone Rs.20000 purchase and perform installation (as As per Betnovate and operational Valerate)…..…. SRO/60ml Lotion by M/s qualifications of TOC analyser and . 100mg GSK Pharma liquid particle Corticosteroid counter in six months time B.P Specifications require to be submitted. 13. -do- Clotri Lotion Form-5 Address provided at form 5 is Each ml 19-10-2015 incomplete. contains:- diary #1471 Stiemazol Internationally availability is not Clotrimazole…. Rs.20000 Lotion by M/s provided by the firm. .….. 10mg As per GSK Pharma Manufacturing method is incomplete Antifungal SRO/20ml & as the firm has not mentioned U.S.P 60ml temperature for manufacturing. Specifications. Raw material specifications are not provided. The firm has mentioned the reference of B.P but the formulation is not present in B.P. 14. -do- Septol Solution Form-5 Deferred for confirmation of Each 100ml 02-11-2015 Savtol Solution approval by reference drug contains:- diary #1781 by M/s regulatory authorities Chlorhexidine Rs.20000 Pharmawise Gluconate As per B.P…..….. SRO/60ml, 300mg 250ml, 500ml Cetrmide & 1000ml B.P…….3gm Anti-infective & disinfectant Manufacturer’s Specifications. 15. -do- Biocheck Form-5 Fakcidine Deferred for confirmation of Solution 02-11-2015 Solution by M/s approval by reference drug Each 100ml diary #1780 Pharmawise regulatory authorities contains:- Rs.20000 Chlorhexidine As per Gluconate SRO/60ml, B.P…..….. 1.5g 250ml, 500ml Cetrirmide & 1000ml B.P…….15gm Anti-infective & disinfectant

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Manufacturer’s Specifications.

16. -do- Sbicon Lotion Form-5 Scabion Lotion Deferred for rectification of Each 100gm 19-10-2015 by M/s Atco following: contains:- diary #1470 Pharma Address provided at form 5 is Crotamiton….. Rs.20000 incomplete. ….. 10gm As per SRO/ Internationally availability is not Sulphur……2 60ml provided by the firm. gm Manufacturing method is incomplete Scabicidal/ as the firm has not mentioned antipruritic temperature for manufacturing. B.P Raw material specifications are not Specifications provided. require to be The firm has mentioned the verified. reference of B.P but the formulation is not present in B.P. 17. -do- Clodrm Lotion Form-5 Clobederm Deferred for rectification of Each gm 19-10-2015 Lotion by M/s following: contains:- diary #1469 Atco Pharma Address provided at form 5 is Clobetasol Rs.20000 incomplete. Proprionate….. As per Internationally availability is not ….. 0.5mg SRO/20ml & provided by the firm. Corticosteroid 60ml Manufacturing method is incomplete U.S.P as the firm has not mentioned Specifications. temperature for manufacturing. Raw material specifications are not provided. In USP it is present as solution. Requires confirmation of segregated facility for the dispensing of steroids. 18. -do- Piodine Form-5 Pyodine Deferred for rectification of Solution 19-10-2015 Solution by following: Each 100ml diary #1468 M/s Brookes Address provided at form 5 is contains:- Rs.20000 Pharma incomplete. Povidone- As per Internationally availability is not Iodine…..….. SRO/60ml & provided by the firm. 10mg 450ml Manufacturing method is incomplete Antiseptic as the firm has not mentioned B.P temperature for manufacturing. Specifications. Raw material specifications are not provided.

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19. -do- Clincin Lotion Form-5 UK. Dalacin T Deferred for rectification of Each ml 19-10-2015 Lotion by M/s following: contains:- diary #1467 Pfizer Pharma Address provided at form 5 is Clindamycin Rs.20000 incomplete. Phosphate eq to As per Dalacin T Internationally availability is not Clindamycin….. SRO/30ml & Lotion by M/s provided by the firm. ….. 10mg 60ml. Pfizer Pharma Manufacturing method is incomplete Antibacterial as the firm has not mentioned U.S.P temperature for manufacturing. Specifications. Raw material specifications are not provided.

20. -do- Denol Liquid Form-5 Dettol Solution Deferred for rectification of Each 100ml 19-10-2015 by M/s Reckett following: contains:- diary #1456 Benckiser Address provided at form 5 is Chloroxylenol Rs.20000 incomplete. …..….. 5gm As per Internationally availability is not Antiseptic SRO/50ml,10 provided by the firm. B.P 0ml &500ml. Manufacturing method is incomplete Specifications. as the firm has not mentioned temperature for manufacturing. Raw material specifications are not provided.

21. -do- Jfenac Injection Form-5 UK Voltral Approved. Liquid 75mg IV 19-10-2015 Injection Condition will be mentioned in Injection Each 3ml diary #1443 75mg/3ml by registration letter that firm will (Gen) contains:- Rs.20000 M/s Novartis purchase and perform installation Ampoule Diclofenac As per SRO and operational Sodium…..….. Dicloran qualifications of TOC analyser and 75mg Injection by liquid particle Antirheumatic M/s Sami counter in six months time IP Specifications require to be verified. 22. -do- Jentacin Form-5 FDA. Injection Approved. Injection 80mg 19-10-2015 Apogen Condition will be mentioned in Each 2ml diary #1445 40mg/ml by registration letter that firm will contains:- Rs.20000 M/s King purchase and perform installation Gentamicin As per SRO Pharma and operational Sulfate eq to qualifications of TOC analyser and Gentamicin….. Ganticyn liquid particle ….. 80mg Injection by counter in six months time Antibiotic M/s Ray B.P pharma Specifications.

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23. -do- Ambroplex Form-5 ______Approved. Injection 19-10-2015 Condition will be mentioned in Each 3ml diary #1465 Neurobion registration letter that firm will contains:- Rs.20000 Injection by purchase and perform installation Thiamine As per SRO M/s Merck and operational HCl(Vitamin qualifications of TOC analyser and B1)…..…..10m liquid particle g counter in six months time Pyridoxine HCl (Vitamin B6)……10mg Cyanocobalami n (Vitamin B12)……1mg B- Complex,Vitam in Manufacturer’s Specifications. 24. -do- Zylocan Form-5 UK. Lidocaine Approved. Injection 19-10-2015 HCl 2% Condition will be mentioned in Each ml diary #1452 solution for registration letter that firm will contains:- Rs.20000 Injection, 2ml, purchase and perform installation Lignocaine As per 5ml, 10ml, by and operational HCl…..….. SRO/10m M/s Hameln qualifications of TOC analyser and 20mg ampoule Pharmaceuticals liquid particle Local counter in six months time Anesthetic Xylocaine B.P Injection by Specifications. M/s Barrett 25. -do- Fertogen-S Form-5 UK. Venofer Approved. Injection 19-10-2015 injection Condition will be mentioned in Each 5ml diary #1455 20mg/ml by registration letter that firm will contains:- Rs.20000 M/s Vifor purchase and perform installation Iron Sucrose As per SRO Pharma. and operational Complex eq to qualifications of TOC analyser and Elemental Rubiject liquid particle Iron…..….. Injection by counter in six months time 100mg M/s AGP Antianaemic USP Specifications. 26. -do- Hycin Injection Form-5 UK. Buscopan Approved. 20mg 19-10-2015 ampoules Condition will be mentioned in Each ml diary #1457 20mg/ml by registration letter that firm will contains:- Rs.20000 M/s Boehringer purchase and perform installation Hyoscine As per SRO and operational Butylbromide… Buscopan qualifications of TOC analyser and

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..….. 20mg Injection by liquid particle Anticholinergic M/s Merck counter in six months time Manufacturer’s Specifications 27. -do- Mcobal Form-5 Approved. Injection 19-10-2015 Methylcobal Condition will be mentioned in 500mcg IM diary #1450 Injection by registration letter that firm will Each ml Rs.20000 M/s Hilton purchase and perform installation contains:- As per SRO and operational Mecobalamin… qualifications of TOC analyser and ..….. 500mcg liquid particle Vitamin B12 counter in six months time analogue Manufacturer’s Specifications 28. -do- Jvit-D Injection Form-5 Approved. 5mg IM 19-10-2015 Condition will be mentioned in Each ml diary #1449 Sunny D registration letter that firm will contains:- Rs.20000 Injection by purchase and perform installation Cholecalciferol As per SRO M/s Scottman and operational …..….. 5mg Pharma qualifications of TOC analyser and Vitamin D3 liquid particle Analogue counter in six months time Manufacturer’s Specifications 29. -do- Cynovit Form-5 Vitaxon Approved. Injection 19-10-2015 Injection by Condition will be mentioned in 500mcg diary #1466 M/s CCL registration letter that firm will Each ml Rs.20000 purchase and perform installation contains:- As per SRO and operational Cyanocobalami qualifications of TOC analyser and n…..….. liquid particle 500mcg counter in six months time Vitamin B12 analogue USP Specifications 30. -do- Water for Form-5 Approved. Injection 19-10-2015 Condition will be mentioned in Each 5ml diary #1463 Water for registration letter that firm will contains:- Rs.20000 Injection by purchase and perform installation Sterile Water As per SRO M/s PDH and operational for Injection qualifications of TOC analyser and WFI liquid particle B.P counter in six months time Specifications .

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CASE NO 2: DEFERRED CASES:

S/ Name and Brand Name Type of Form International Remarks / N address of (Proprietary name + Initial date, status in stringent Observations manufacturer / Dosage Form + diary regulatory Applicant Strength) Fee including agencies Composition differential fee Pharmacological Group Demanded Me-too status Finished product Price / Pack size Specification GMP status as depicted in inspection report (dated)

31. M/s Zafa Pharmaceuticals, Karachi has now applied for Registration of new dosage form on prescribed Form 5- D, along with differential fee of Rs. 30,000/- with the same Brand Name Cordiclean Gel 4% (previously applied on Form 5 along with prescribed fee of Rs. 20,000/-) as per decision of 247th meeting of Registration Board held on 04th February 2015 wherein it was emphasized that “therapeutic use” of the subject drug was different as 0.2% Chlorhexidine Gel has a role in oral care whereas “7.1% Chlorhexidine Digluconate Gel (4% active Chlorhexidine)” is indicated for umbilical cord care in neonates. Therefore, all the firms shall apply for registration of 7.1% Chlorhexidine Digluconate Gel (4% active Chlorhexidine)” on Form-5D. M/s Zafa Cordiclean Gel 4% Form 5-D for Registered by Deferred for Pharmaceutical Each gram contains new dosage form Department of  Real time stability s Laboratories Chlorhexidine Gluconate with prescribed Drug data needs to be (Pvt.) Ltd, L- 7.1% equivalent to fee of Rs. Administration of furnished by the firm 1/B, Block 22, Chlorhexidine 4% w/w 50,000/- vide Nepal, as per 251st meeting Federal “B” Diary No. N/A manufactured by recommendations. Industrial Area, Bisbiguanide Disinfectant dated 21-07- Lomus  Approval of API by Karachi. BP Specification 2014 & Diary Pharmaceuticals regulatory authority No. 313 dated (Khatmandu, of country of origin 31-08-2015 Nepal) or GMP certificate of API manufacturer WHO issued by regulatory Pack size of recommendation in authority of country 20gm Tube / Rs. year 2012 of origin. 100 Reference :  Documentation Pack Size of http://www.usp.org confirming import of 4gm Tube /Rs. /sites/default/files/u API 35 sp_pdf/EN/PQM/c  Commitment to hlorhexidine_techn continue real time ical_brief_jul_1_20 stability study till 14.pdf assigned shelf life of the product. GMP compliant Cream/Ointment Section

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32. M/s Searle IV Solutions (Private) Limited (Formerly Mac & Rains Pharmaceuticals Pvt. Ltd) applied for registration of drug on prescribed Form 5 for the brand name AA II IV Injection.

The case was initially presented in 242nd meeting of RB held on 24th – 25th February 2015 for rectification of shortcomings in the application.

The case was then again discussed in 251st meeting of RB held on 12th – 13th August 2015 wherein case was deferred for confirmation of me too status of the firm due to additional ingredient in me too status i.e. L- Leucine….4.10gm which was missing in proposed formulation.

The decision was accordingly communicated to the firm. Firm has now submitted reply wherein they elaborated that their proposed formulation on the prescribed Form 5, is exactly same as innovator brand i.e. Pan-Amin G (a brand property of Otsuka, Japan). It was a typographical error occurred during recording of minutes of 242nd meeting of RB by missing one of the ingredients in proposed formulation, due to which case was deferred in 251st meeting of RB. M/s Searle IV AA II IV Injection Form 5 fast track Pan-Amin G Approved. Solutions 9905 R&I dated (Japan) Condition will be (Private) Each 1000 ml contains 21-08-2013 mentioned in Limited L- Arginine HCl 2.7gm Locally registration letter that (Formerly Mis L-Histidine HCl H2O manufactured by firm will Mac & Rains 1.3gm Pack size of Otsuka, Pakistan purchase and perform Pharmaceutica L-Isoleucine 1.8gm 500ml / Rs. (Pan –amin G) installation and ls Pvt. Ltd), 1.5 L-Leucine 4.1gm 394.45 operational km, Manga L-Lysine HCl 6.2gm 1000ml / Rs. qualifications of TOC Raiwind Road, L-Methionine 2.4gm 670.57. GMP compliant analyser and liquid Manga Mandi, L-Phenylalanine 2.9gm section vide particle Distt. Lahore. L-Threonine 1.8gm inspection report counter in six months L-Tryptophan 0.6gm time L-Valine 2.0 gm Glycine (Aminoacetic acid) 3.4gm D. Sorbitol 50gm Water for Injection Q.S Free AA: 2.7% (w/v) E/N 3.1 Total Nitrogen 4.3gm/L Osmolarity 507 mOsm/L

Aminoacids (Manufacture Specification)

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33. M/s Martin Sparta Sachet Form 5 fee Hepa-merz (Merz Approved Dow Limited, 20,000/- , 1067 Pharmaceuticals, Plot # 37, Each Sachet contains dated 30-06- Germany) Sector 19, L-Ornithine-L-Aspartate 2014. Korangi 3gm The case was Industrial Area, (Cholagogues and Hepatic Unit Pack size deferred in 252nd Karachi. Protectors) Sachet 5’s, 10’s meeting of DRB & 30’s as per for certain SRO shortcomings which firm has submitted and now dossier is complete.

34. M/s Global Pharmaceuticals located at Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad had applied for registration of Tamsol-D capsule [Dutasteride/Tamsulosin 0.5mg/0.4mg]. The case was presented in 251st meeting of the Registration Board held on 12th – 13th August 2015 wherein the Board advised the firm to provide approval of soft gelatin capsule (steroidal).

Now firm has submitted letter of Soft Gelatin Capsule (Steroidal) Section approved in 243rd meeting of the Central Licensing Board held on 9th September 2015.

Meanwhile, firm has submitted a request to Pharmaceutical Evaluation Cell on 11-08-2015 for correction of the dossier as under:-

i. Firm stated that they have applied for registration of Tamsol-D Capsule for which they will not manufacture Tamsulosin HCl pellets at their premises but will source from M/s Vision Pharmaceuticals , Plot # 22-23, Industrial Triangle Kahuta Road, Islamabad. ii. By mistake, they mentioned its dosage form as Soft Gelatin Capsule whereas its actual dosage form is Hard

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Gelatin Capsule containing tamsulosin HCl modified release pellets and Dutasteride as soft gelatin capsule which is the same formulation as per innovator brand. iii. Instead of primary packing in blisters, the packing of this product shall be opaque, white high density polyethylene (HDPE) bottles with polypropylene child resistant closures with induction seal liners.

M/s Global Tamsol-D Capsule Form 5 FDA approved  Firm has mentioned Pharmaceuticals 20,000/- Jalyn Capsules encapsulation (Private) Each Hard Gelatin Capsule Dy. No. 4275 (GSK) machine of JT-J11 Limited, Plot # contains (07-07-2015) (China) which is not 204-205, Softgel capsules of Duodart (GSK) compatible for multi- Industrial Dutasteride … 0.5 mg and

Triangle, Kahuta Tamsulosin HCl USP ……. Pack of product dosing and Road, Islamabad. 0.4 mg (as modified release 30 Capsules per New Section filling in hard gelatin pellets 0.2%) bottle as per capsule (filling of SRO softgel capsule and 4- synthetic azasteroid + pellets in hard gelatin Alpha Blocker capsule). (Manufacture Spec)

Source of pellets M/s Vision Pharmaceuticals , Plot # 22-23, Industrial Triangle Kahuta Road, Islamabad. Preceeding of the Board:- The Board discussed in detail with respect to novality and technicality of the product as the finished product contains two different dosage forms (modified release pellets of tamsulosin and softgel capsule of dutasteride) in final finished dosage form i.e. Hard gelatin capsule. The Board enlightened that technology/equipment of filling two different dosage forms in the final finished dosage form i.e. hard gelatin capsule, should be automated system and needs product specific inspection. Decision:- The Board approved the product and directed the area FID to conduct product specific inspection for verification of technology/equipment for filling two different dosage form in the final finished dosage form of pellets and soft gelatin capsule into hard gelatin shell and apprised the Board in upcoming meeting of the Board. The Board authorized its Chairman for issuance of registration letter after confirmation of facility by FID. Deferred cases of 250th meeting of RB for certain shortcomings which firm has rectified now.

Tablet (General) 35. M/s Adamjee Tablet Nordip 5mg Form 5 FDA approved Pharmaceutica Rs. 20,000/- Amlodipine ls (Pvt.) Ltd, Each tablet contains dated 15-11- Besylate 5 mg Approved Plot -39, Amlodipine Besylate USP 2010 &30-07- (Mylan) Sector-15, equivalent to Amlodipine 2013 Korangi 5mg Norvasc (Pfizer) Industrial Pack size of 20 Area, Karachi. Calcium Channel Blockers tablets, 10 tablets GMP compliance (USP Specification) per Blister / as level of Tablet per SRO (General) Section

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of the firm rated Good by panel inspection report dated 18th September 2014.

36. -do- Tablet Nordip 10mg Form 5 FDA approved Rs. 20,000/- Amlodipine Each tablet contains dated 15-11- Besylate 5 mg Approved Amlodipine Besylate USP 2010 &30-07- (Mylan) equivalent to Amlodipine 2013 10mg Norvasc (Pfizer) Pack size of 20 Calcium Channel Blockers tablets, 10 tablets (USP Specification) per Blister / as per SRO

37. -do- Tablet Paragesic 450/35 Form 5 TGA approved Deferred as product is Rs. 20,000/- Norgesic (iNova) under review Each tablet contains dated 15-11- Paracetamol BP 450mg 2010 &30-07- Samerol (Sami) Orphendrine Citrate BP 2013 35mg Pack size of 100 Skeleton Muscle tablets (10 x 10), relaxant/analgesic 10 tablets per (Manufacture Blister / as per Specification) SRO

38. -do- Tablet Paragesic 650/50 Form 5 Internationally Deferred for Rs. 20,000/- product available in consideration of Review Each tablet contains dated 15-11- the same strength Committee. Paracetamol BP 650mg 2010 &30-07- in Philippines only. Orphendrine Citrate BP 2013 50mg Pack size of 100 Samerol - N (Sami) Skeleton Muscle tablets (10 x 10), relaxant/analgesic 10 tablets per (Manufacture Blister / as per Specification) SRO 39. -do- Tablet Lortad 10mg Form 5 MHRA approved Rs. 20,000/- Tablet Loratadine Each film coated tablet dated 15-11- (Generics [UK] Approved contains 2010 &30-07- /mylan) Loratadine USP 10mg 2013 Piperidine Derivative Adin (Nimrall) (USP Specification) Pack size of 10’s/ as per SRO

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40. -do- Tablet Foxin 180mg Form 5 FDA approved Rs. 20,000/- Tablet Each film coated tablet dated 15-11- Fexofenadine Approved contains 2010 &30-07- (BARR) Fexofenadine USP 180mg 2013 Antihistamine Fexet (Getz) (USP Specification) Pack size of 10’s/ as per SRO

41. -do- Tablet Foxin 120mg Form 5 FDA approved Rs. 20,000/- Tablet Each film coated tablet dated 15-11- Fexofenadine Approved contains 2010 &30-07- (BARR) Fexofenadine USP 120mg 2013 Antihistamine Fexet (Getz) (USP Specification) Pack size of 10’s/ as per SRO

42. -do- Tablet Foxin 60mg Form 5 FDA approved Rs. 20,000/- Tablet Each film coated tablet dated 15-11- Fexofenadine Approved contains 2010 &30-07- (BARR) Fexofenadine USP 60mg 2013 Antihistamine Fexet (Getz) (USP Specification) Pack size of 10’s/ as per SRO

Tablet (Psychotropic) 43. -do- Tablet Clotril 0.5mg Form 5 FDA approved Rs. 20,000/- Tablet Clonazepam Each film coated tablet dated 15-11- (Actavis) Approved contains 2010 &30-07- Clonazepam USP 0.5mg 2013 Clonazil (English) Benzodiazepine (USP Specification) Pack size of 50’s/ as per SRO

44. -do- Tablet Clotril 2mg Form 5 FDA approved Rs. 20,000/- Tablet Clonazepam Each film coated tablet dated 15-11- (Actavis) Approved contains 2010 &30-07- Clonazepam USP 2mg 2013 Clonazil (English)

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Benzodiazepine Pack size of 3 x (USP Specification) 10’s/ as per SRO

Capsule (General) 45. -do- Capsule Tempa 15mg Form 5 FDA approved Rejected as Firm Rs. 20,000/- Capsule Restoril doesn’t possess Each Capsule contains dated 15-11- (MALLINCKRO segregated section for Temazepam USP 15mg 2010 &30-07- DT INC) manufacturing of Benzodiazepine 2013 Capsule (Psychotropic) (USP Specification) Hypnotil (P.D.H) as per requirement. Pack size of 1 x 10’s capsule/ as per SRO

46. -do- Capsule Tempa 30mg Form 5 FDA approved Rejected as firm doesn’t Rs. 20,000/- Capsule Restoril possess segregated Each Capsule contains dated 15-11- (MALLINCKRO section for Temazepam USP 30mg 2010 &30-07- DT INC) manufacturing of Benzodiazepine 2013 Capsule (Psychotropic) (USP Specification) Hypnotil (P.D.H) as per requirement. Pack size of 1 x 10’s capsule/ as per SRO

47. -do- Capsule Phlozed 50mg Form 5 International Deferred for Rs. 20,000/- availability not  Legalized GMP status Each Capsule contains dated 15-11- provided. of source of pellets. Diclofenac Sodium (32% 2010 &30-07-  Stability data w/w enteric coated pellets) 2013  International equivalent to Diclofenac Phlogin (Brookes) availability of same Sodium 50mg Pack size of 50 dosage form in reference SRAs. NSAID x 10’s capsule/ (Manufacture as per SRO Specification)

Source of pellets Glukem Pharmaceuticals (Pvt.) Ltd,Plot # 205/2A, IDA, Phase II, Cheriapally, Hyderabad. 48. -do- Capsule Phlozed SR Form 5 International Deferred for 100mg Rs. 20,000/- + availability not  Legalized GMP status 80,000/- dated provided. of source of pellets. Each Capsule contains 15-11-2010  Stability data Diclofenac Sodium (32% &30-07-2013 &  International Dycnom (Genome) w/w enteric coated pellets) 04-08-2015 availability of same

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equivalent to Diclofenac dosage form in Sodium 100mg Pack size of 50 reference SRAs. NSAID x 10’s capsule/ (Manufacture as per SRO Specification)

Source of pellets Glukem Pharmaceuticals (Pvt.) Ltd,Plot # 205/2A, IDA, Phase II, Cheriapally, Hyderabad. Oral Solution 49. -do- Lortad Oral Solution Form 5 MHRA approved Rs. 20,000/- Clarityn Allergy Each ml contains dated 15-11- 1mg/ml Syrup Approved Loratadine USP 1mg 2010 &30-07- (Bayer, UK) Antihistamine 2013 (USP Specification) Antial (Sami) Pack size of 60ml/ as per SRO

Evaluator IV DEFERRED CASES 50. M/s Soma Sotran 500 Form-5 Hixamic of M/s Approved Laboratories, Capsule Dy. No: Himont Plot # 43-D, Each Capsule contains: 4385 dated. Chemicals. Sundar Industrial Tranexamic 09-07-15 It exist as 650mg Estate Raiwind Acid……500mg Rs.20000/- tablets in USFDA Road Lahore. Anti-Fibrinolytic Agent (As per and 500mg tablets (Capsule SRO) 20’s in MHRA. It exist General) as capsule in japanes Pharmacopiea but strength not clear. 51. M/s Soma Ezole-40 Form-5 Esso of M/s Source: vision pharmaceuticals, Laboratories, Capsule Dy. No: Shaigan. Islamabad. Plot # 43-D, Each Capsule contains: 4383 dated. USFDA Sundar Industrial Esomeprazole (as 09-07-15 Approved Estate Raiwind megnesium) enteric coated Rs.20000/- Road Lahore. pellets……40mg (As per (Capsule Anti-Ulcer SRO) 2x7’s General) USP-32 Specs 52. M/s Soma Ezole-20 Form-5 Esso of M/s Source: vision pharmaceuticals, Laboratories, Capsule Dy. No: Shaigan. Islamabad. Plot # 43-D, Each Capsule contains: 4386 dated. USFDA USFDA Sundar Industrial Esomeprazole (as 09-07-15 Approved Estate Raiwind megnesium) enteric coated Rs.20000/-

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Road Lahore. pellets ……20mg (As per (Capsule Anti-Ulcer SRO) 14’s General) USP-32 Specs

53. M/s Soma Eprazole-20 Form-5 Acezole Source: vision pharmaceuticals, Laboratories, Capsule Dy. No: Of M/s T.G. Islamabad. Plot # 43-D, Each Capsule contains: 4387 dated. Pharma Sundar Industrial Omperazole as enteric 09-07-15 Approved Estate Raiwind coated pellets……20mg Rs.20000/- Road Lahore. Anti-Ulcer (As per (Capsule USP-32 Specs SRO) 14’s General)

54. M/s Soma Eprazole-40 Form-5 Acezole Source: vision pharmaceuticals, Laboratories, Capsule Dy. No: Of M/s T.G. Islamabad. Plot # 43-D, Each Capsule contains: 4388 dated. Pharma Sundar Industrial Omperazole as enteric 09-07-15 Approved Estate Raiwind coated pellets……40mg Rs.20000/- Road Lahore. Anti-Ulcer (As per (Capsule USP-32 Specs SRO) 14’s General)

55. M/s Hi-Medic Hyphin Injection 1 gm Form 5 Rocephin Approved pharmaceuticals Each vial contains:- 04-08-2015 Injection 1gm by private limited Ceftriaxone Sodium USP Rs.20,000/- Martin Dow 19- km link eq toCeftriaxone 1.0 gm 597/- per Pharmaceuticals- multan road Injection (IV) pack(1’s) Karachi Lahore (Cephalosporin) USFDA USP specs. 56. Hyphin Injection 500 mg Form 5 Rocephin Approved -do- Each vial contains:- 04-08-2015 Injection 500 mg Ceftriaxone Sodium USP Rs.20,000/- By M/s Martin eq toCeftriaxone 500 mg 299/- per Dow Injection (IV) pack Pharmaceuticals- (Cephalosporin) Karachi. USP specs. USFDA 57. Hyphin Injection 250 mg Form 5 Rocephin -do- Each vial contains:- 04-08-2015 Injection 250 mg Ceftriaxone Sodium USP Rs.20,000/- By m/s Martin eq to Ceftriaxone 250 mg 141.4/- per Dow Approved Injection (IV) pack Pharmaceuticals- (Cephalosporin) Karachi. USP specs. USFDA 58. -do- Clocef Oral Suspension Form 5 Ceclor Oral Approved 250 mg/5ml 04-08-2015 Suspension Each 5 ml contains:- Rs.20,000/- 250mg/5ml by Cefaclor Monohydrate eq 60 ml – m/s to Cefaclor USP 250 mg/5 328.53/- AGP Karachi, ml Suspension Pakistan (Cephalosporin) (US-FDA) USP specs.

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59. -do- Clocef Oral Suspension Form 5 Ceclor Oral Approved 125 mg/5ml 04-08-2015 Suspension Each 5 ml contains:- Rs.20,000/- 125mg/5ml by Cefaclor Monohydrate eq 60 ml – m/s to Cefaclor USP 125mg/5 187.94/- AGP Karachi, ml Suspension Pakistan (Cephalosporin) (US-FDA) USP specs. 60. -do- Form 5 Duricef Oral Deferred for Roxil Oral Suspension Suspension 125mg/5ml 04-08-2015 125mg/5ml by  Clarification of formulation of Each 5 ml contains:- m/s pack size and quantity per 5 Cefadroxil Monohydrate eq Rs.20,000/- ml. to Cefadroxil USP Glaxosmithkline 125mg/5 ml Suspension 60 ml – Pakistan Ltd (Cephalosporin) 161.63/- Karachi, Pakistan USP specs. (USFDA) 61. M/s Jaskan Ciprokan 250/5ml Case was approved in 243rd meeting with remarks letter will be issued after Pharmaceuticals Dry suspension rectification of shortcomings. (pvt) Ltd, Each 5ml contains: Remarks:- Ciprofloxacin Oral Suspension is available in 250mg/5 ml and sundar Ciprofloxacin HCl 500mg/5 ml strengths. industrial equivalent to Adults: : 250 mg twice daily to 750 mg twice daily depending upon nature and severity of infection. Estate, Lahore. ciprofloxacin……..250mg Peads: ≥1 year (PO): 10-20 mg/kg q12hr; individual dose not to exceed 750 Antibiotic mg q12hr (UTI). USP-32 Specs Description: Ciprofloxacin Oral Suspension is available in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. Ciprofloxacin Oral Suspension is a white to slightly yellowish suspension with strawberry flavor which may contain yellow-orange droplets. It is composed of ciprofloxacin microcapsules and diluent which are mixed prior to dispensing . The components of the suspension have the following compositions:  Microcapsules–ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20.  Diluent–medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor.  Five (5) mL of 5% suspension contains approximately 1.4 g of sucrose and 5 mL of 10% suspension contains approximately 1.3 g of sucrose. (Ref: US FDA) Decision of RB in 250th meeting in light of above remarks. i. Applicants shall revise their formulation as per innovator ( new registration application with complete fee) within six months if manufacturing facility is approved by CLB , ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be adopted. Otherwise show cause notices shall be issued for deregistration of drugs in this formulation. iii. All such application shall be processed on priority basis.

Decision: Case was deferred for further deliberation on the type and nature of diluent used to reconstitute the FPP .

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Evaluator I

62. M/s. Wimits Anti-Diarrhea 1.Form-5 Diarroban Pharmaceutical Water Soluble 2.03-01-2014 Powder by M/s Approved with change of brand. s, Powder Dy. No.16 Star Plot No.129, Each gm 3.03-01-2014 Sunder contains:- Rs.20,000/- Industrial Neomycin Decontrolled\ Estate (P.I.E) Sulphate BP pack size Raiwind Road, 33.33 mg 12gm Lahore. Streptomycin 250gm Sulphate BP 500gm 33.33 mg 1 Kg Sulphaguanidin e BP 333.33 mg Kaolin USP 333.33 mg Pectin USP 33.33 mg Bismuth Sub nitrate USP 166.66 mg Vitamin A Acetate BP 2.291 mg (Anti-Diarrheal & Antibiotic) Finished product specifications are Manufacturer 63. -do- Mega Flush 1.Form-5 Filtrax WSP Approved Water Soluble 2.03-01-2014 Powder Dy. No.18 Each gm 3.03-01-2014 contains:- Rs.20,000/- Calcium Decontrolled\ Pantothenate BP pack size 5mg 100g Methenamine 250g BP 500g (Hexamethylene 1 Kg Tetramine) 2.5 Kg 995mg Vitamin B2 BP….10mg Nicotinamide

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BP…25mg (Diuretic & Minerals.) Finished product specifications are Manufacturer. 64. M/s Wise Linzo Liquid Form-5 Deferred for Verification of the Pharmaceutical Infusion 455 diary no. facility for LVP by licesing division s, plot # 3-A, dated 18-02- stret S-I, Each 300ml 2014 RCCI, contains:- Rs.20,000 Industrial Linzolid…….60 As per Estate, Rawat, 0mg SRO/300ml Rawalpindi. Oxazolidinone glass vial Manufacturer’s Specifications 65. -do- Moximag Form-5 Deferred for Verification of the Liquid Infusion 443 diary no. facility for LVP by licesing division dated 18-02- Each 250ml 2014 contains:- Rs.20,000 Moxifloxacin as As per HCl…….400m SRO/250ml g glass vial Fluroquinolone Manufacturer’s Specifications 66. M/s. Himont 1.Cardiogin 1. Form 5 2. a.Manufacturer Approved Pharmaceutical HCT 300/25mg Fast Track 3. b.Me too s (Pvt) Ltd. 17- Tablets As per SRO (Rasilez HCT Km, Ferozepur Printed of Novartis) Road, Lahore 2.Tablets 3. cardboard box c. The firm was Each film containing 14 inspected on coated Tablet tablets 29-08-2013 by contains: inblister 4. area FID and Aliskiren Dy. No.------the firm was (Hemifumarate) dated ------advised to make ……………….. -- 5. 21-10- improvements 300mg 2013 regarding Hydrochlorothia Rs.60,000/- documentation, zide SOP’s, test and ……………… analysis and … 25mg also advised to rectify 4. Renin shortcomings as Inhibitor and mentioned in

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Diuretic the report and (Antihypertensi submit ve Agents) compliance report. Manufacturer’s Specifications

67. -do- 1.Cardiogin 1. Form 5 a.Manufacturer’ Approved Tablets s 2. Fast Track b.Me too ( 2.Tablets Rasilez of 3. Rs.490/- Naovartis) 3. Each film Pack of 7 c.The firm was coated Tablet tablets contains: inspected on Aliskiren 4. Dy. No.589 29-08-2013 by (Hemifumarate) dated 21-10- area FID and …. 150mg 2013 5. 21- the firm was 10-2013 advised to make 4. Renin Rs.60,000/- improvements Inhibitor regarding (Antihypertensi documentation, ve Agents) SOP’s, test and analysis and Manufacturer’s also advised to Specifications rectify shortcomings as mentioned in the report and submit compliance report.

68. -do- 1.Cardiogin 1. Form 5 a.Manufacturer Approved HCT b.Me too 300/12.5mg 2. Fast Track (Rasilez HCT Tablets of Novartis) 3. Rs.1638/- c. The firm was 2.Tablets 14 tablets inspected on 29-08-2013 by 3. Each film 4. Dy. No.586 area FID and coated Tablet dated 21-10- the firm was contains: 2013 5. 21- advised to make Aliskiren 10-2013 improvements (Hemifumarate) Rs.60,000/- regarding …. 300mg documentation, Hydrochlorothia SOP’s, test and zide … 12.5mg analysis and

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also advised to 4. Renin rectify Inhibitor and shortcomings as Diuretic mentioned in (Antihypertensi the report and ve Agents) submit compliance Manufacturer’s report. Specifications 69. -do- 1.Cardiogin 1. Form 5 a.Manufacturer Approved Tablets b.Me too ( 2. Fast Track Rasilez of 2.Tablets Naovartis) 3. Rs.819/- c. The firm was 3. Each film Pack of 7 inspected on coated Tablet tablets 29-08-2013 by contains: area FID and Aliskiren 4. Dy. No.588 the firm was (Hemifumarate) dated 21-10- advised to make …. 300mg 2013 5. 21- improvements 10-2013 regarding 4. Renin Rs.60,000/- documentation, Inhibitor SOP’s, test and (Antihypertensi analysis and ve Agents) also advised to rectify Manufacturer’s shortcomings as Specifications mentioned in the report and submit compliance report.

70. M/s Nabiqasim Modton Tablet Form 5-D The product is Deferred for verification of the fee Industries Pvt 25mg deferred for the challan. Ltd, Karachi. Each film Rs. 52,000/- evaluation of coated tablet and 5000(only registration as contains photocopies per approved Agomelatine are attached checklist. 25mg require to be Antidepressant verified) Manufacturer’s 24.01.2013 specifications and 08.05.2013

Dy. No. 1709 R&I

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Price: 1500/- per pack 10’s

CASE NO.3 ANOMALLY CASES

EVALUATOR IV S/ Name and Brand Name Type of Form International Remarks / N address of (Proprietary name + Initial date, status in stringent Observations manufacturer / Dosage Form + diary regulatory Applicant Strength) Fee including agencies Composition differential fee Pharmacological Group Demanded Me-too status Finished product Price / Pack size Specification GMP status as depicted in inspection report (dated)

Veterinary Oral Powder (General) 71. M/s Bio-Oxime BIODOX FORTE ORAL Form 5 Pharmaceutica POWDER WSP Rs. 20,000/- vide Tylodoxyco Plus Approved ls, Plot # 31,32 Dy. No. 48 dated Powder Millat Each 1000 gm contains 10-07-2015 (Cherished) Garment City Doxycycline (as HCl) BP Faisalabad. 200gm Tylosin Tartrate BP Pack size of Oral Powder 100gm 10,30,100 gm, Section is GMP Bromhexine HCl BP 500gm, 1000gm, compliant vide 10gm 5000 gm inspection report of jars/Sachet/Box panel dated 26-02- Antibiotics 2015. Veterinary Preparation Decontrolled (Manufacture Specification) 72. -do- NEOCIN 72 ORAL Form 5 POWDER Rs. 20,000/- vide 72% Neomycin Approved Dy. No. 49 dated Powder (Weal Each 1000 gm contains 10-07-2015 Pakistan) Neomycin Sulphate 720gm Pack size of Antibiotics 10,30,100gm, Veterinary Preparation 500gm, 1000gm,

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(Manufacture 5000 gm Specification) jars/Sachet/Box

Decontrolled

73. -do- SPIRALINK ORAL Form 5 POWDER Rs. 20,000/- vide Spiralin WSP Approved Dy. No. 47 dated (Symans, Pakistan) Each gm contains 10-07-2015 Spiramycin Adipate 75mg Lincomycin HCl 25mg Pack size of Antibiotics 10,30,100gm, Veterinary Preparation 500gm, 1000gm, (Manufacture 5000 gm Specification) jars/Sachet/Box

Decontrolled 74. -do- ERYSUL-T ORAL Form 5 POWDER Rs. 20,000/- vide Erythro T.S Approved Dy. No. 50 dated (Nawan) Each 1000 gm contains 10-07-2015 Erythromycin Thiocyanate C.P.V 100gm Trimethoprim B.P 20gm Pack size of Sulphadiazine B.P 100gm 10,30,100gm, 500gm, 1000gm, Antibiotics 5000gm Veterinary Preparation jars/Sachet/Box (Manufacture Specification) Decontrolled 75. -do- EFLOSIN ORAL Form 5 POWDER Rs. 20,000/- vide Respinil 50 oral Approved Dy. No. 51 dated Powder (Sanna Each 1000 gm contains 10-07-2015 Lab) Tylosin Tartrate 50gm Furaltadone 140gm Erythromycin 60gm Pack size of 10,30,100gm, Antibiotics 500gm, 1000gm, Veterinary Preparation 5000 gm (Manufacture jars/Sachet/Box Specification)

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Decontrolled

Veterinary Oral Liquid (General)

76. M/s Bio- FLOXACOL FORTE Form 5 Oxime ORAL LIQUID Rs. 20,000/- vide ENRO STIN Oral Approved Pharmaceutic Dy. No. 52 dated Liquid (Bio-Labs) als, Plot # Each 100 ml contains 10-07-2015 31,32 Millat Enrofloxacin 10 gm Garment City Colistin Sulphate 50 MIU Oral Liquid Section Faisalabad. Pack size of is GMP compliant Antibiotics 10ml, 50ml , vide inspection Veterinary Preparation 100ml, 250ml, report of panel (Manufacture 500ml, 1000ml, dated 26-02-2015. Specification) 5000ml

Decontrolled 77. -do- NORFLOX FORTE Form 5 ORAL LIQUID Rs. 20,000/- vide NOXABAR-20 Approved Dy. No. 53 dated (Baariq) Each 100 ml contains 10-07-2015 Norfloxacin HCl 20gm

Antibiotics Pack size of Veterinary Preparation 10ml, 50ml , (Manufacture 100ml, 250ml, Specification) 500ml, 1000ml, 5000ml

Decontrolled

Tablet (Psychotropic) Section 78. M/s Bloom Tablet ALEPTAL 30mg Form 5 MHRA approved Deferred for Pharmaceutic Rs. 20,000/- vide Tablet commitment required als (Pvt.) Ltd, Each Tablet contains Dy. No. 3357 Phenobarbital to be furnished as per Plot # 30, Phenobarbitone U.S.P dated 14-01- (Actavis, UK) decision of RB. Phase I & II, 30mg 2015 Industrial Phenobarbitone Estate, Barbiturates Pack size of tablet (Munawar Hattar. 10 tablets per Pharma) (USP Specification) strip in box of 3 x 10’s – Price as per SRO Tablet (Psychotropic) Decontrolled GMP compliant vide inspection

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report of panel dated 08-12-2014.

79. -do- Tablet REVEL 1mg Form 5 MHRA approved Deferred for Rs. 20,000/- vide Tablet Lorazepam  Commitment Each Tablet contains Dy. No. 3358 (Morningside required to be Lorazepam B.P 1mg dated 14-01- Healthcare furnished as per 2015 Limited, UK) Benzodiazepines decision of RB. Pack size of Tenzil (Atco)  Firm needs to (BP Specification) 10 tablets per furnish the written strip in box of 10 procedure for x 10’s – Price as Tablet dissolution test of per SRO (Psychotropic) the tablet protected GMP compliant Decontrolled vide inspection from light as report of panel requirement in BP dated 08-12-2014. specification. 80. M/s Treat Tricip DS Infusion Form 5 International Internationally product Pharmaceutic Rs. 20,000/- availability not is not available in the al Industry Each 100 ml contains dated 20-03- provided strength proposed by Pvt Ltd, A-37, Ciprofloxacin (As Lactate) 2014 the firm therefore the Small 400mg Quinoflox (Bosch) Industrial Pack size of Board advised firm to Estate Quinone Antibiotics 100 ml glass revise formulation as Township, vials as per SRO per decision of 250th Kohat Road, (USP Specification) meeting of RB. Bannu. 81. -do- Moxit Infusion Form 5 MHRA approved Approved. Rs. 20,000/- Avelox Condition will be Each 250ml Glass vial dated 20-03- manufactured by mentioned in contains 2014 Bayer registration letter that Moxifloxacin (as HCl) firm will 400mg Pack size of Avelin (Bosch) purchase and perform Antibiotics 250 ml glass installation and (Manufacture vials as per SRO operational Specification) qualifications of TOC analyser and liquid particle counter in six months time

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Evaluator II

82. M/s Espoir Es-Fibrol Form-5 Fybogel Deferred for Pharmaceuticals Sachet Dy. No: 553 Mebeverine By  Last inspection PCSIR KCL, Each Sachet contains: dated. Reckitt Benckiser report. Karachi. Mebevrine Hcl BP ….. 135mg 13-4-2015 Healthcare (UK)  Commitment as per Ispaghula Husk BP …..3.5gm Rs.20,000/- MHRA 251st meeting not (Antispasmodies & As per SRO Mevulak Sachet provided by the Articholiergies) (sami) Firm.  Correct Form 5. 83. M/s Espoir Montilet Sachet Form-5 Singulair Granule Deferred for Pharmaceuticals Sachet Dy. No: 555 By Merck Sharp  Last inspection PCSIR KCL, Each Sachet contains: dated. and Dohme, UK report. Karachi. Monelukas Sodium……4mg 13-4-2015 MHRA, USFDA  Commitment as per (Anti-asthma Leuketrienne Rs.20,000/- Singulair (OBS 251st meeting not Recpton) As per SRO Pharma) provided by the Firm.  Correct Form 5. 84. M/s Espoir Stron Sachet Form-5 Protelos Sachet By Deferred for Pharmaceuticals Sachet Dy. No: 552 LES Laboratories  Last inspection PCSIR KCL, Each Sachet contains: dated. Servier, France report. Karachi. Strontium Ranelate …….. 2gm 13-4-2015 Onita Sachet  Commitment as per (Postmenopausal osteoporosis) Rs.20,000/- (Pharmevo) 251st meeting not As per SRO provided by the Firm.  Correct Form 5. 85. M/s Paramount Cefy Chewable Tablet Form-5 Suprax by m/s Deferred for Pharmaceuticals, Tablets Dy. No: 1728 Lupin Pharma  Confirmation of Me Plot No 36 Kahuta Each Tablet contains: dated. (USFDA) too or application on Road, Islamabad. Cefixime Trihydrate…..112.50 09-09-2015 As per firm’s form 5D. (Cephalosporin) Rs.20,000/-dated. statement and u/s  FTIR. USP Specs. 08-09-2015 knowledge me too  Commitment as per As per SRO/ not available. 251st meeting of RB. 1x10’s  From process flow chart it seems that its film coated tablet.  Official monograph of Cefixime chewable tablet. 86. M/s Paramount Cefy Chewable Tablet Form-5 Suprax by m/s Deferred for Pharmaceuticals, Tablets Dy. No: 1727 Lupin Pharma  Confirmation of Me Plot No 36 Kahuta Each Tablet contains: dated. (USFDA) too or application on Road, Islamabad. Cefixime Trihydrate…..225mg 09-09-2015 As per firm’s form 5D. (Cephalosporin) Rs.20,000/-dated. statement and u/s  FTIR. USP Specs. 08-09-2015 knowledge me too  Commitment as per As per SRO/ not available. 251st meeting of RB. 1x10’s  From process flow chart it seems that its film coated tablet.

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 Official monograph of Cefixime chewable tablet. 87. M/s Paramount Cefy Tablet Form-5 Suprax by m/s Deferred for Pharmaceuticals, Tablets Dy. No: 1726 Lupin Pharma  Commitment as per Plot No 36 Kahuta Each Tablet contains: dated. (USFDA) 251st meeting of RB. Road, Islamabad. Cefixime Trihydrate…..450mg 09-09-2015 Sanxim by m/s  FTIR. (Cephalosporin) Rs.20,000/-dated. Everest Pharma USP Specs. 08-09-2015 As per SRO/ 1x5’s 88. M/s Paramount Parlokast Dry Susp. 5mg/5ml Form-5 International Commitment as per 251st Pharmaceuticals, Suspension Dy. No: 1725 availability not meeting not provided by Plot No 36 Kahuta Each 5ml contain contains: dated. confirm. the Firm. Road, Islamabad. Montelukast Sodium…..5mg 09-09-2015 Lulast by m/s Label Claim Not Clear. (Antiashthematic) Rs.20,000/-dated. Hygeia Montelukast is Manufacturer Specs. 08-09-2015 approved as 4-mg oral As per SRO/ granules in sachet 60ml dosage form. The innovators instructions for administrations are as follows: “The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, SINGULAIR oral granules must not be stored for future use. Discard any unused portion. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration.” (Ref: US FDA) Decision of RB in 250th meeting: 1.Rejected as the formulation is not

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approved in reference drug regulatory agencies. 2.Show cause notice for deregistration of already registered formulations. Decision: As per Decision of 250th meeting. Evaluator I

89. M/s A & K Sinco Injection Form 5 Approved. Pharmaceutical, Each ml contains:- 01-08-2013 diary I-Spiralink Condition will be 94-A, Punjab Lincomycin as # 996 Rs.20,000 Injection by M/s mentioned in Small Industrial HCl……..125mg Decontrolled International registration letter that Estate, Sargodha Spiramycin as /10ml, 20ml, 50ml, Pharma. firm will Road, Faisalabad. Adipate…….75mg & 100ml purchase and perform Antibiotic Manufacturere’s Specifications installation and operational qualifications of TOC analyser and liquid particle counter in six months time

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Case No.4 ROUTINE CASES Evaluator IV IMPORT CASES S/ Name and Brand Name Type of Form International Decision N address of (Proprietary name + Initial date, status in stringent manufacturer / Dosage Form + diary regulatory Applicant Strength) Fee including agencies Composition differential fee Pharmacological Group Demanded Me-too status Finished product Price / Pack size Specification GMP status as depicted in inspection report (dated)

90. M/s Bayer ADVANTAN MILK Form 5-A Advantan Milk Registration Board Pakistan Rs. 100,000/- (Bayer,Italy) deferred the product for (Private) Each 1gm Advantan Milk vide Dy. No. 328 marketing fresh legalized COPP as Limited, Bahria contains dated 03-06- authorization in per WHO format. Complex II, 4th Methylprednisolone 2011 & 11-10- EEA countries floor, M.T. Aceponate 1mg (0.1%) 2012 (European Khan Road, Economic Areas) Karachi. Glucocorticosteroid Austria, Belgium, cutaneous emulsion One tube of Bulgaria, Cyprus, Intendis 20gm/ 750 PKR Czech Republic, Manufacturing (Manufacture Estonia, Finland, S.P.A, Via E Specification) Germany, Greece, Schering, 21, Hungary, Italy, 20090 Segrate Lithuania, Latvia, (Milan) Italy Luxembourg, Portugal, Romania, Slovenia.

91. M/s Matrix PRESINEX 10mcg Nasal Form 5-A MHRA approved Approved Pharma, Plot # Spray Solution Rs. 100,000/- nasal spray 12, Sector 15, vide Dy. No. 135 manufactured by Korangi Each actuation contains dated 21-04- Actavis, Iceland. Industrial Area, 10mcg 2011 & Dy. No. Karachi. (Desmopressin acetate 779 dated 05-04- MIPHARM hydrate 0.600mg 2013 S.P.A, VIA corresponds to BERNARDO Desmopressin 0.534 mg) Pack size of QUARANTA, 2.5ml (25 12-20141 Antidiuretic Synthetic sprays) / 1766.79 MILANO (MI) Hormone PKR (Manufacture 6ml (60 sprays) /

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Specification) 3,533.58 PKR

EVALUATOR IV S/ Name and Brand Name Type of Form International Decision N address of (Proprietary name + Initial date, status in stringent manufacturer / Dosage Form + diary regulatory Applicant Strength) Fee including agencies Composition differential fee Pharmacological Group Demanded Me-too status Finished product Price / Pack size Specification GMP status as depicted in inspection report (dated)

Veterinary Oral Powder (Penicillin) 92. M/s Westmont AMOXIMONT Form 5 Rejected as firm doesn’t Pharmaceutical POWDER Rs. 20,000/- vide Amco Tech, Vet possess dedicated section Industry, Mini Dy. No. 76 dated Pharma Animal for penicillin Industrial Each 1000 gm contains 08-03-2011 & Health Estate, G.T Amoxicillin Trihydrate 31-07-2013 Road, Gujar 200gm Khan, Distt. Colistin Sulphate 500000 Rawalpindi. IU Pack size of plastic sealed Penicillin Antibiotics container Veterinary Preparation 100gm, 500gm, (Manufacture 1000gm. Specification) Decontrolled Veterinary Oral Powder (General) 93. -do- HEXAMONT POWDER Form 5 Registration Board Rs. 20,000/- vide Kerry Flush Water deferred for latest Each 100 gm contains Dy. No. 76 dated Soluble Powder inspection report of the Methenamine BP …. 08-03-2011 & (Biolabs, Pakistan) firm. 90gm 31-07-2013 Vitamin B1 BP …. 0.7gm GMP status Vitamin C BP …. Pack size of satisfactory rated 0.1gm plastic sealed ‘B” vide inspection Sorbitol BP …. 5gm container report dated 10-01- 100gm, 500gm, 2014. Diuretic 1000gm. Veterinary Preparation 2500gm.

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(Manufacture Decontrolled Specification)

94. -do- AVITOTAL POWDER Form 5 Registration Board Rs. 20,000/- vide Gumbozal (Snam deferred for latest Each 1000 gram contains Dy. No. 75 dated Pharma) inspection report of the Ammonium Chloride BP 08-03-2011& firm. 650mg 31-07-2013 Vitamin A BP 25000 IU Vitamin C BP 100gm Methionine BP 100gm Pack size of Sorbitol BP 50mg plastic sealed container Vitamin Preparation 100gm, 500gm, Veterinary Preparation 1000gm. (Manufacture Specification) Decontrolled 95. -do- FLOXADINE POWDER Form 5 Registration Board Rs. 20,000/- vide Acedine (Leads) deferred for latest Each 100gm contains Dy. No. 77 dated inspection report of the Amantadine (as HCl) BP 08-03-2011& firm. 10 gm 30-07-2013

Antibiotic/antibacterial Veterinary Preparation Pack size of (Manufacture plastic sealed Specification) container 100gm, 500gm.

Decontrolled 96. -do- DEFTA PLUS ORAL Form 5 Registration Board POWDER Rs. 20,000/- vide Tylo Plus (Sung deferred for latest Each 100 gm contains Dy. No. 63 dated Microbiological inspection report of the Doxycycline (BP) …. 08-03-2011 & Lab) firm. 12gm 30-07-2013 Tylosin Tartrate BP…. 12gm Pack size of Erythromycin BP …. plastic sealed 12gm container Amantadine BP …. 4gm 100gm, 500gm, Antibiotics/Antibacterials 1000gm. Veterinary Preparation Decontrolled (Manufacture Specification)

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97. -do- FRUSIUM ORAL Form 5 Registration Board POWDER Rs. 20,000/- vide F-Flush Powder deferred for latest Dy. No. 78 dated (Attabak) inspection report of the Each 1000 gm contains 08-03-2011 & firm. Furosemide BP …. 20gm 30-07-2013 Sodium Chloride BP …. 35gm Magnesium Sulphate BP Pack size of 35gm plastic sealed Manganese Sulphate BP container 1gm 100gm, 500gm, Potassium Chloride BP 1000gm. 4gm Calcium Carbonate BP Decontrolled 45gm

Flusher Veterinary Preparation (Manufacture Specification) 98. -do- BROPHYLINE ORAL Form 5 Registration Board POWDER Rs. 20,000/- vide deferred for latest Dy. No. 76 dated inspection report of the Each 1000 gm contains 08-03-2011 & Neo broncho CTC firm. Bromhexine …. 5gm 31-07-2013 (Biogen) Chlortetracycline HCl BP …. 80gm Neomycin as Sulphate …. Pack size of 70gm plastic sealed Colistin Sulphate BP…. container 4gm 100gm, 500gm, 1000gm. Antibiotic/Antibacterials Veterinary Preparation Decontrolled (Manufacture Specification) 99. -do- FLOROX ORAL Form 5 Registration Board POWDER Rs. 20,000/- vide Naflor (Nawan) deferred for latest Dy. No. 64 dated inspection report of the Each gm contains 08-03-2011 & firm. Florphenicol M.S 50mg 30-07-2013

Antibiotic/Antibacterial Veterinary Preparation Pack size of (Manufacture plastic sealed Specification) container 100gm, 500gm, 1000gm.

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Decontrolled

100. -do- L-S-A 100 ORAL Form 5 Registration Board POWDER Rs. 20,000/- vide Specnolin deferred for latest Dy. No. 64 dated (Mediexcel inspection report of the Each 100gm contains 08-03-2011 & Pharma) firm. Lincomycin (as HCl) BP 30-07-2013 …. 3.3gm Spectinomycin (as 2HCl.5H2O) BP.. 6.67gm Pack size of plastic sealed Antibacterial/Antibiotic container Veterinary Preparation 100gm, 500gm, (Manufacture Specification) Decontrolled 101. -do- SES-3 ORAL POWDER Form 5 Registration Board Rs. 20,000/- vide Amantadox-T deferred for latest Each 100 gm contains Dy. No. 64 dated (Baariq) inspection report of the Tylosin Tartrate BP 10gm 08-03-2011 & firm. Doxycycline (as Hyclate) 30-07-2013 BP 20gm Amantadine (as HCl) BP Pack size of 4.5gm plastic sealed container Antibacterial / Antibiotics 100gm, 500gm, Veterinary Preparation 1000gm. (Manufacture Decontrolled Specification) 102. -do- Ambro-Tet POWDER Form 5 Registration Board Rs. 20,000/- vide N-OX-C (Nawal) deferred for latest Each 100gm contains Dy. No. 64 dated inspection report of the Neomycin Sulphate 20gm 08-03-2011 & firm. Oxytetracycline (as HCl) 30-07-2013 BP 20gm Colistin Sulphate BP 55miu Pack size of plastic sealed Antibiotic/Antibacterial container Veterinary Preparation 100gm, 500gm, (Manufacture 1000gm. Specification) Decontrolled

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103. -do- AMANTAFLOX Form 5 Registration Board POWDER Rs. 20,000/- vide Hidoxin (Decent) deferred for latest Dy. No. 64 dated inspection report of the Each 1000 gm contains 08-03-2011 & firm. Doxycycline (as Hyclate) 30-07-2013 BP….. 200gm Tylosin Tartrate BP Pack size of 100gm plastic sealed Amantadine (as HCl) BP container 40gm 100gm, 500gm.

Antibiotic/antibacterial Decontrolled Veterinary Preparation (Manufacture Specification) 104. -do- NEOCLOZIN ORAL Form 5 Registration Board POWDER Rs. 20,000/- vide deferred for latest Dy. No. 76 dated CRD PLUS inspection report of the Each gm contains 08-03-2011 & (Aligance) firm. Streptomycin Sulphate BP 31-07-2013 200mg Colistin Sulphate BP 20mg Pack size of Tylosin Tartrate BP plastic sealed 100mg container 100gm, 500gm, 1000gm. Veterinary Preparation 2500gm. (Manufacture Decontrolled Specification) 105. -do- SULFAZINE 30% Form 5 Registration Board POWDER Rs. 20,000/- vide ESB 3 30-Hilton deferred for latest Dy. No. 76 dated inspection report of the Each 100 gm contains 08-03-2011 & firm. Sulfaclozine sodium (as 31-07-2013 monohydrate) USP 30gm

Anti cocciddal Pack size of Veterinary Preparation plastic sealed (Manufacture container Specification) 100gm, 500gm, 1000gm. 2500gm. Decontrolled

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106. -do- BRONCODOX FORTE Form 5 Pulmo-Forte WSP Registration Board POWDER Rs. 20,000/- vide (Attabak) deferred for latest Dy. No. 76 dated inspection report of the Each gm contains 08-03-2011 & firm. Tylosin Tartrate BP 10mg 31-07-2013 Doxycycline (as Hyclate) BP 20mg Colistin Sulphate BP Pack size of 500000 IU plastic sealed Bromhexine BP 5mg container 100gm, 500gm, Antibiotic/Antibacterial 1000gm. Veterinary Preparation (Manufacture Decontrolled Specification) 107. -do- LINCOSPECT ORAL Form 5 Seltin (D-Maarson) Registration Board POWDER Rs. 20,000/- vide deferred for latest Dy. No. 76 dated inspection report of the Each kg contains 08-03-2011 & firm. Lincomycin as HCl 50gm 31-07-2013 Spectinomycin (as 2HCl.5H2O) BP 100gm Amantadine (as HCl) BP Pack size of 30gm plastic sealed container Antibiotic/Antibacterial 100gm, 500gm, Veterinary Preparation 1000gm. (Manufacture Specification) Decontrolled 108. -do- COLIMENTACHLOR Form 5 Flumveterinary Registration Board POWDER Rs. 20,000/- vide powder 10% (Epla) deferred for latest Dy. No. 76 dated inspection report of the Each 100 gm contains 08-03-2011 & firm. Flumequine BP 10gm 31-07-2013

Antibiotic/Antibacterial Veterinary Preparation Pack size of (Manufacture plastic sealed Specification) container 100gm, 500gm.

Decontrolled

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109. -do- NEOXYMONT Form 5 NE-OXY CHLOR Registration Board POWDER Rs. 20,000/- vide (Farm Aid Group) deferred for latest Dy. No. 76 dated inspection report of the Each KG contains 08-03-2011 & firm. Neomycin Sulphate BP 31-07-2013 150gm Oxytetracycline (as HCl) USP 300gm Pack size of Chloramphenicol (BP) plastic sealed 100gm container 100gm, 500gm, Antibiotic/Antibacterial 1000gm. Veterinary Preparation (Manufacture Decontrolled Specification) 110. -do- AMANTYDOX Form 5 Alphadox 35% Registration Board POWDER Rs. 20,000/- vide (Noble) deferred for latest Dy. No. 76 dated inspection report of the Each kg contains 08-03-2011 & firm. Tylosin Tartrate BP 31-07-2013 100gm Doxycycline BP 200gm Amantadine HCl 50gm Pack size of plastic sealed Antibiotic/Antibacterial container Veterinary Preparation 100gm, 500gm, (Manufacture 1000gm. Specification) Decontrolled

Veterinary Oral Liquid

111. M/s Biogen B.G C.Clor-N Oral Form 5 Neo-Stin (ICI) Registration Board Pharma, 8km Solution Rs. 20,000/- vide approved the product as Rawat Chak Dy. No. 76 dated firm has rectified Beli Road, Each Liter contains 08-03-2011 & shortcomings Rawat. Colistin Sulphate BP 4gm 16-12-2013 Neomycin Sulphate BP70gm Chortetracycline HCl BP White plastic 80gm Bottles of 100ml, 250ml, 500ml, Antibiotic/Antibacterial 1000ml. Veterinary Preparation

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(Manufacture Decontrolled Specification) 112. -do- Symodex Oral Liquid Form 5 Adek Excel Oral Registration Board Rs. 20,000/- vide Solution (Nawan) approved the product as Each ml contains Dy. No. 76 dated firm has rectified Vitamin A BP…. 10,000 08-03-2011 & shortcomings IU 16-12-2013 Vitamin D3 USP…. 2000 IU Vitamin E USP…… 4mg White plastic Vitamin K3 ….. 2mg Bottles of 100ml, 250ml, 500ml, Multivitamins 1000ml. Veterinary Preparation (Manufacture Decontrolled Specification) Veterinary Oral Powder (General) 113. -do- Bromodox Water Soluble Form 5 Bromodox WSP Registration Board Powder Rs. 20,000/- vide (Symans) approved the product as Dy. No. 76 dated firm has rectified Each 1000gm contains 08-03-2011 & shortcomings Tylosin Tartrate (BP) 16-12-2013 200gm Doxycycline (as Hyclate) BP 250gm White plastic Bromhexine HCl BP Jars and Sachet 5000mg of 100gm, 250gm, 500gm, Antibiotic/mucolytic 1kg. Veterinary Preparation (Manufacture Decontrolled Specification) 114. -do- B.G Saline Water Soluble Form 5 Bio-reyl Powder Deferred for Me too Powder Rs. 20,000/- vide (Biolabs) status as provided me too Dy. No. 76 dated formulation is different Each 100gm contains 08-03-2011 & from proposed Ammonium Chloride BP 16-12-2013 formulation. 4gm Magnesium Sulphate BP 25gm White plastic Sodium Sulphate BP Jars and Sachet 24.5gm of 100gm, 250gm, 500gm, Flusher/Diuretic 1kg, 2.5kg, 5kg Veterinary Preparation (Manufacture Decontrolled Specification)

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115. -do- B.G Aspro-C Water Form 5 Super Cool WSP Registration Board Soluble Powder Rs. 20,000/- vide (Intervac) approved the product as Dy. No. 76 dated firm has rectified Each 100gm contains 08-03-2011 & shortcomings Aspirin BP 6.7% 16-12-2013 Vitamin C BP 20%

Antipyretic/Vitamin White plastic Veterinary Preparation Jars and Sachet (Manufacture of 100gm, Specification) 250gm, 500gm, 1kg.

Decontrolled 116. -do- Colidoxin Water Soluble Form 5 Pulmopro (Breeze) Registration Board Powder Rs. 20,000/- vide approved the product as Dy. No. 362 firm has rectified Each kg contains dated 19-01- shortcomings Tylosin Tartrate 100gm 2011 & Dy. No. Doxycycline HCl 200gm 419 dated 17-12- Colistin Sulphate 500 2013 MIU Bromhexine HCl 5gm White plastic Antibiotics/Mucolytic Jars and Sachet Veterinary Preparation of 100gm, (Manufacture 250gm, 500gm, Specification) 1kg.

Decontrolled 117. -do- B.G FrusebellWater Form 5 Frusa fas Powder Registration Board Soluble Powder Rs. 20,000/- vide (Intervac) approved the product as Dy. No. 362 firm has rectified Each 100gm contains dated 19-01- shortcomings Furosemide 2% 2011 & Dy. No. Extract Belladona 0.2% 421 dated 17-12- 2013 Diuretic Veterinary Preparation White plastic (Manufacture Jars and Sachet Specification) of 100gm, 200gm, 250gm, 500gm, 1kg.

Decontrolled

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118. -do- B.G Suntol Water Soluble Form 5 Tiknol Coumaphos Registration Board Powder Rs. 20,000/- vide (Medivet) approved the product as Dy. No. 431 firm has rectified Each 100gm contains dated 19-01- shortcomings Coumaphos 50% 2011 & Dy. No. 421 dated 17-12- 2013 Veterinary Preparation (Manufacture White plastic Specification) Jars and Sachet of 100gm, 250gm, 500gm, 1kg.

Decontrolled 119. -do- Tetracin Water Soluble Form 5 Not provided Deferred for me too Powder Rs. 20,000/- vide status Dy. No. 367 Each 100gm contains dated 19-01- Chlortetracycline 20gm 2011 & Dy. No. Neomycin Sulphate 6gm 421 dated 17-12- 2013 Antibiotics Veterinary Preparation White plastic (Manufacture Jars and Sachet Specification) of 100gm, 250gm, 500gm, 1kg.

Decontrolled

Veterinary Liquid Injection Section 120. M/s Elko Mico sol Injection Form 5 Micotil 300 FDA Approved. Organization Rs. 20,000/- vide approved Condition will be (Pvt.) Ltd, 27 Each ml contains Dy. No. 402 mentioned in & 28, Sector Tilmicosin (as Phosphate) dated 18-01- registration letter that 12/B, North 300mg 2011 & dated Tilcolina Injection firm will Karachi 31-12-2013 (Alina) purchase and perform Industrial Macrolide Antibiotics installation and Area, Karachi. (USP Specification) Glass Vials operational container of qualifications of TOC 100ml analyser and liquid particle Decontrolled counter in six months time

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Eye Drops 121. M/s Medipak Lubrosoft Eye Drop Form 5 MHRA approved Approved Limited, 132 Rs. 20,000/- vide Hypromellose Industrial Each ml contains Dy. No. 383 0.3% w/v Eye Estate, Kot Hypromellose 3mg dated 19-09- Drops Solution Lakhpat 2011 & 1084 (Blumont Pharma, Lahore. Lubricants dated 19-07- UK) (USP Specification) 2013 Softeal (Sante) LDPE pack of 5ml & 10 ml as per Leader Brand. Veterinary Liquid Injectable (General) 122. M/s Symans COLIFLOR INJECTION Form 5 Deferred for Pharmaceutica Rs. 20,000/- vide Naflor (Nawan) ls (Private) Each ml contains Dy. No. 448  To furnish the Limited, 10km Florfenicol 300mg dated 20-01- proposed route of Sheikhupura 2011 & 122 administration i.e. Road, Lahore. Antibiotics (Amphenicols) dated 19-09- IM, IV, Veterinary Preparation 2013 Subcutaneous etc. (BP Specification)  Latest Inspection pack of 10ml, report of the panel. 50ml, 100ml &  To provide proof of 500ml availability of GC Decontrolled chromatography instrument as required for the chemical assay of Florfenicol.  Commitment to be furnish as per decision of RB.  To provide one pack size for each injctable registration.  Provide photocopy of the pages of British pharmacopeia the proposed finished product alongwith details of physical and chemical assay

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parameters.

123. -do- COLIFLOR Liquid Form 5 Deferred for Rs. 20,000/- vide Neflox (Selmore) Each ml contains Dy. No. 447  Latest Inspection Florfenicol 230mg dated 20-01- report of the panel. 2011 & 122  Commitment to be Antibiotics (Amphenicols) dated 19-09- furnish as per Veterinary Preparation 2013 decision of RB. (BP Specification)  To provide proof of pack of 100ml, availability of GC 500ml, 1000ml chromatography & 25L instrument as Decontrolled required for the chemical assay of Florfenicol.

124. -do- Tylo-Forte Liquid Form 5 Deferred for Rs. 20,000/- vide Macrodox (Prix) Each 100 ml contains Dy. No. 445  Latest Inspection Tylosin Tartrate BP 20gm dated 20-01- report of the panel. Doxycycline HCl BP 2011 & 122  Commitment to be 25gm dated 19-09- furnish as per 2013 decision of RB. Antibiotics (Amphenicols)  To provide proof of Veterinary Preparation pack of 100ml, availability of GC (Manufacture 500ml, 1000ml chromatography Specification) & 25L instrument as Decontrolled required for the chemical assay of Florfenicol.

Eye Drops 125. M/s Vega Lubricane Eye Drops Form 5 Systane (Alcon) Approved Pharmaceutica Rs. 20,000/- vide ls (Pvt.) Ltd, Each ml contains Dy. No. 2009 Systane (Alcon) 30km, Multan Polyethylene Glycol 400 dated 29-09- Road, Lahore. …. 0.4% 2010 & 1001 GMP level of Eye Propylene Glycol 0.3% dated 22-05- Drop Section rated 2014 good by panel for Eye Lubricant inspection of (Manufacture pack of 15ml renewal of DML Specification) vial / 250 PKR on 23-10-2014.

Evaluator-I

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S/N Name and Brand Name Type of International Decision address of (Proprietary Form status in manufacture name + Dosage Initial date, stringent r / Applicant Form + diary regulatory Strength) Fee including agencies Composition differential Pharmacological fee Me-too status Group Demanded Finished product Price / Pack GMP status as Specification size depicted in inspection report (dated)

126. M/s Enclomont Oral Form 5 Registration Board deferred for latest Westmont Liquid 08-03-2011 inspection report of the firm. Pharmaceutic Each 100ml diary # 87 Avienro-C by al Industries, contains:- R&I M/s Avicenna Mini Enrofloxacin…10 Decontrolled Industrial gm /100ml,250ml Estate, G.T Colistin ,500ml, Last inspection Road, Gujar Sulphate..…50MI 1000ml report is not Khan, U provided. Rawalpindi. Antibiotic/antibac terial Manufacturer’s Specifications 127. -do- Floricol-20 Oral Form 5 Registration Board deferred for latest Liquid 08-03-2011 Neflox 23% by inspection report of the firm. Each 1000ml diary # 29 M/s Selmore contains:- R&I Pharma. Florphenicol..… Decontrolled …230gm /100ml,250ml Anti bacterial ,500ml, Last inspection Manufacturer’s 1000ml report is not Specifications provided. 128. -do- EN-Broxin Oral Form 5 ______Registration Board deferred for latest Liquid 08-03-2011 inspection report of the firm and Each 100ml diary # 86 remaining fee Rs.12000/- contains:- R&I Me to status Enrofloxacin Decontrolled provided by the base..……10gm /100ml,250ml firm does not Bromhexine…… ,500ml, exist needs …0.5gm 1000ml clarification Anti bacterial/antibioti c Last inspection Manufacturer’s report is not

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Specifications. provided. 129. -do- Floxacure 20 Oral Form 5 ______Registration Board deferred for latest solution 08-03-2011 inspection report of the firm. Each 1000ml diary # 81 contains:- R&I Ofloxin Ofloxacin…100g Decontrolled Solution by M/s m /100ml,250ml Sonia Pharma Anti ,500ml, bacterial/antibioti 1000ml c Last inspection Manufacturer’s report is not Specifications provided. 130. -do- Floramont-25 Form 5 ______Registration Board deferred for latest Oral Liquid 08-03-2011 inspection report of the firm. Each 1000ml diary # 80 contains:- R&I Nobiflor Liquid Florphenicol…25 Decontrolled by M/s Noble 0gm /250ml,500ml Pharma Anti bacterial , 1000ml Manufacturer’s Specifications Last inspection report is not provided. 131. -do- T.D.A Soper Oral Form 5 ______Registration Board deferred for latest Powder 08-03-2011 inspection report of the firm. Each 1000gm diary # 90 contains:- R&I Me to status Doxycycline(B.P) Decontrolled provided by the …200gm /100gm,250g firm does not Tylosine Tartrate m,500gm, exist needs (B.P)….100gm 1000gm clarification Colistine Sulphate….450M IU Last inspection Bromhexine…04 report is not gm provided. Anti bacterial/antibioti c Manufacturer’s Specifications 132. -do- Safocin Oral Form 5 ______Registration Board deferred for latest Powder 08-03-2011 inspection report of the firm. Each 1000gm diary # 91 contains:- R&I Me to status Neomycin Decontrolled provided by the Sulphate…150gm /100gm,,500g firm does not

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Oxytetracycline m, 1000gm exist needs …..100gm clarification Florphenicol….1 00gm Ascorbic Last inspection Acid…100gm report is not Salicylic provided. Acid…50gm Anti bacterial/antibioti c Manufacturer’s Specifications 133. M/s Intervac Prednifas Form 5 ______Deferred for (Pvt) Ltd, 18 Injection 28-04-2011  Finished product specifications Km Lahore Each ml diary # 217 are not provided. Sheikhupura contains:- R&I Orasone  Segregated vials section approval Road, Prednisolone as Decontrolled Injection by is not provided. Sheikhupura. Acetate 25mg /10ml, 30ml, M/s Breez  Firm is claiming benzyl alcohol Steroid 50ml, 100ml, Pharma as local anesthetic. Require to be 200ml  The firm do not have distillation provided unit for the manufacturing of Last inspection WFI. report is not  Differential fee of 12000 is not provided. provided.  Last inspection report conducted within period of 1 year is not provided.  Commitment as per the decision of Board is not provided.  Outline method of manufacture is not provided.  As per policy of Board only one registration be granted for one application.

134. -do- Novafas Injection Form 5 ______Deferred for Each ml 28-04-2011  Finished product specifications contains:- diary # 205 are not provided. Novaminsulfon… R&I Require to be  Firm has not mentioned the ..40mg Decontrolled verified as vehicle for dilution. Etilefrin…..0.2m /10ml, 20ml, already  The firm do not have distillation g 50ml, 100ml, provided by the unit for the manufacturing of Calcium 250ml, firm is not WFI. Gluconate….110 400ml, 500ml correct.  Differential fee of 12000 is not mg provided. Magnesium  Last inspection report conducted

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Gluconate….10m Last inspection within period of 1 year is not g report is not provided. Sodium provided.  Commitment as per the decision Salicylate….7mg of Board is not provided. Nicotinamide….0  Outline method of manufacture .3mg is not provided. Caffeine…10mg  As per policy of Board only one Boric registration is granted for one Acid…10mg application. Antibiotic and Supplement Require to be provided 135. -do- Dexafas Injection Form 5 ______Deferred for Each ml 28-04-2011  Finished product specifications contains:- diary # 211 are not provided. Dexamethasone R&I Me to status  Segregated vial section approval Sodium Decontrolled require to be is required. Phosphate eq. to /50ml, 100ml, verified as the  The firm do not have distillation Dexamethasone 200ml,500ml, firm has unit for the manufacturing of … 1mg provided is WFI. Steroid incorrect.  Differential fee of 12000 is not Require to be provided. provided  Last inspection report conducted Last inspection within period of 1 year is not report is not provided. provided.  Commitment as per the decision of Board is not provided.  Outline method of manufacture is not provided.  As per policy of Board only one registration be granted for one application.

136. -do- Intervit Plus Form 5 ______Deferred for Injection 28-04-2011  Finished product specifications Each 100ml diary # 222 are not provided. contains:- R&I Firm has  The firm do not have distillation Vitamin Decontrolled provided but it unit for the manufacturing of A….5MIU /10ml, 30ml, is incorrect WFI. Vitamin 50ml, 100ml,  Differential fee of 12000 is not D3…1MIU 200ml, 500ml provided. Vitamin E Last inspection  The firm do not have facility for Acetate…2gm report is not testing some of items in the Vitamin C provided. formulation as lysine etc ….2.5gm  Last inspection report conducted Vitamin within period of 1 year is not

Minutes for 254th Registration Board Meeting 286

B1….600mg provided. Vitamin B2  Commitment as per the decision …100mg of Board is not provided. Vitamin  Outline method of manufacture B6…500mg is not provided. Vitamin  As per policy of Board only one B12…5mg registration be granted for one Nicotinamide…1 application. gm Calcium Pantothenate….6 00mg Biotin…5mg Folic Acid….10mg Lysine…1mg Methionine…1m g Copper Sulphate….10mg Zinc Sulphate…10mg Magnesium Sulphate…10mg Vitamins & Minerals Require to be provided 137. -do- Fluxifas Injection Form 5 ______Deferred for Each ml 28-04-2011  Finished product specifications contains:- diary # 203 are not provided. Flunixin as R&I Firm has  The firm do not have distillation Meglumine….50 Decontrolled provided the unit for the manufacturing of mg /10ml, 20ml, reference which WFI. Anti 30ml, 50ml, require to be  Differential fee of 12000 is not Inflammatory 100ml, 200ml checked provided. Require to be  Last inspection report conducted provided Last inspection within period of 1 year is not report is not provided. provided.  Commitment as per the decision of Board is not provided.  Outline method of manufacture is not provided.  As per policy of Board only one registration be granted for one application.

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138. -do- Prostifas Injection Form 5 ______Deferred for Each ml 28-04-2011  Finished product specifications contains:- diary # 210 are not provided. Cloprostenol R&I Require to be  The firm do not have distillation Sodium B.P 263 Decontrolled verified unit for the manufacturing of mcg eq to /1ml, 2ml, WFI. Cloprostenol Last inspection  Differential fee of 12000 is not 250mcg report is not provided. Not provided provided.  Last inspection report conducted Require to be within period of 1 year is not provided provided.  Commitment as per the decision of Board is not provided.  Outline method of manufacture is not provided.  As per policy of Board only one registration be granted for one application.

139. -do- Amivit Plus Form 5 ______Deferred for Injection 28-04-2011  Finished product specifications Each ml diary # 230 are not provided. contains:- L- R&I Firm has  Firm is claiming benzyl alcohol Arginine Decontrolled provided but it as local anesthetic. HCl….1.44mg /10ml, 30ml, is incorrect  The firm do not have distillation L-Cysteine 50ml, 100ml, unit for the manufacturing of HCl….3.20mg 200ml WFI. L- Last inspection  Differential fee of 12000 is not Glutamine……3. report is not provided. 20mg provided.  Details of column used for the Glycine…3.20mg testing of amino acids is not L- provided. Histidine.1.32mg  Last inspection report conducted L- within period of 1 year is not Isoleucine….3.60 provided. mg  Commitment as per the decision L-Leucine of Board is not provided. HCl….4.28mg  Outline method of manufacture L-Lysine is not provided. HCl..….5.44 As per policy of Board only one L-  registration be granted for one Methionine….3.2 application. 0mg

L- threonine…3.20m g L-

Minutes for 254th Registration Board Meeting 288

Tryptophan…0.8 6mg L- Phenylalanine…. 5mg L- Valine….3.60mg Thiamine HCl….4mg Riboflavin Sodium Phosphate….0.17 mg Pyridoxine HCl…0.34mg Nicotinamide …8mg Ascorbic Acid…4mg Glucose ….33mg Calcium Chloride…0.08m g Potassium Chloride….0.21m g Magnesium Chloride…0.08m g Amino acid, vitamins & electrolytes Require to be provided 140. -do- Mettycoli Form 5 ______Deferred for Injection 28-04-2011  Finished product specifications Each ml diary # 224 are not provided. contains:- R&I Firm has  The firm do not have distillation Dimetridazole…1 Decontrolled provided that is unit for the manufacturing of 00mg /10ml, 30ml, incorrect WFI. Colistin 50ml, 100ml,  Differential fee of 12000 is not Sulphate…..10mg 200ml provided. Tylosin Last inspection  Last inspection report conducted Tartrate….50mg report is not within period of 1 year is not Antibiotic provided. provided. Require to be  Commitment as per the decision provided of Board is not provided.

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 Outline method of manufacture is not provided.  As per policy of Board only one registration be granted for one application.

141. M/s Prix Priclosan Form 5 ______Approved. Pharmaceutic Injection 01-12-2011 Condition will be mentioned in a (Pvt) Ltd, Each ml diary # 418 registration letter that firm will Plot # 5-contains:- Rs.8000 R&I Santel injection purchase and perform installation Pharmacity, Closantel …50mg & Rs.12000 of M/s Ghazi and operational 30-Km Anthelmintic/anti vide diary # Brothers qualifications of TOC analyser and Multan Road, parasitic 1096 dated liquid particle Lahore. Manufacturer’s 21-08-2013 Inspection counter in six months time specifications Decontrolled / report dated 05- 50ml 03-2015 by the FID Firm is GMP compliant. 142. -do- Imidopri Injection Form 5 ______Approved. Each ml 01-12-2011 Condition will be mentioned in contains:- diary # 436 registration letter that firm will Imidocarb as Rs.8000 R&I Imipro 12% purchase and perform installation dipropionate & Rs.12000 injection by M/s and operational …120mg vide diary # Selmore qualifications of TOC analyser and Antiprotozoan 1094 dated Pharma liquid particle Manufacturer’s 21-08-2013 counter in six months time Specifications Decontrolled /50ml Inspection report dated 05- 03-2015 by the FID Firm is GMP compliant. 143. -do- Prigent 20 Form 5 ______Approved. Injection 01-12-2011 Condition will be mentioned in Each ml diary # 417 registration letter that firm will contains:- Rs.8000 R&I Atneg 20% by purchase and perform installation Gentamycin & Rs.12000 M/s Elko and operational Sulphate eq to vide diary # Pharma qualifications of TOC analyser and Gentamycin 1098 dated liquid particle …..200mg 21-08-2013 counter in six months time Aminoglycosides Decontrolled Inspection USP /50ml report dated 05- Specifications 03-2015 by the FID Firm is GMP

Minutes for 254th Registration Board Meeting 290

compliant.

144. -do- TMP Plus Form 5 ______Approved. Injection 01-12-2011 Condition will be mentioned in Each ml diary # 427 registration letter that firm will contains:- Rs.8000 R&I Combisulph purchase and perform installation Sulphamerazine & Rs.12000 Injection by and operational …..100mg vide diary # M/s Cherished qualifications of TOC analyser and Sulphadiazine…. 1097 dated Pharma liquid particle 60mg 21-08-2013 counter in six months time Sulphathiazole…. Decontrolled Inspection ...40mg 50ml report dated 05- Trimethoprim… 03-2015 by the …40mg FID Firm is Sulphonamides GMP Manufacturer’s compliant. Specifications 145. -do- Pri-Gold Line Form 5 ______Approved with change in brand Injection 01-12-2011 name. Each 100ml diary # 429 Condition will be mentioned in contains:- Rs.8000 R&I Novacoc Fort registration letter that firm will Novaminsulfon… & Rs.12000 by M/s Richter purchase and perform installation .4gm vide diary # Pharma Austria and operational Calcium 974 dated 31- (Waseem qualifications of TOC analyser and Gluconate….10g 07-2013 impex) liquid particle m Decontrolled counter in six months time Magnesium /250ml Gluconate…..1g Inspection m report dated 05- Nicotinamide….. 03-2015 by the 0.03gm FID Firm is Sodium alpha GMP compliant Oxybenzylphosph inic acid…..0.50gm Sorbite……20gm Caffeine …..0.35gm Sodium salicylate….0.35g m Boric Acid….1gm Methylparahydro xybenzoate….0.0 7gm

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Minerals, Vitamins, Cardio- stimulant, analgesic Manufacturer’s Specifications 146. -do- Pironil Plus Form 5 ______Approved. Injection 01-12-2011 Condition will be mentioned in Each ml diary # 428 registration letter that firm will contains:- Rs.8000 R&I Tryptowan purchase and perform installation Diminazine & Rs.12000 Injection by and operational aceturate…….10 vide diary # M/s Nawan qualifications of TOC analyser and 5mg 975 dated 31- liquid particle Antipyrine……13 07-2013 counter in six months time 1mg Decontrolled / Inspection Antiprotozoan 50ml report dated 05- Manufacturer’s 03-2015 by the Specifications FID Firm is GMP compliant 147. -do- Atropri Forte Form 5 ______Approved. Injection 01-12-2011 Condition will be mentioned in Each ml diary # 420 registration letter that firm will contains:- Rs.8000 R&I Atrostar By M/s purchase and perform installation Atropine & Rs.12000 Star and operational Sulphate……15m vide diary # qualifications of TOC analyser and g 972 dated 31- Inspection liquid particle Antimuscrinic 07-2013 report dated 05- counter in six months time USP Decontrolled 03-2015 by the Specifications /50ml FID Firm is GMP compliant 148. -do- Pri-SilverLine Form 5 ______Approved with change in brand Injection 01-12-2011 name Each ml diary # 425 Condition will be mentioned in contains:- Rs.8000 R&I Novastar by registration letter that firm will Novaminsulfon & Rs.12000 M/s Star labs purchase and perform installation (USP)…...40mg vide diary # and operational Etilefrin (as HCl) 976 dated 31- qualifications of TOC analyser and B.P…..0.2mg 07-2013 Inspection liquid particle Calcium Decontrolled report dated 05- counter in six months time Gluconate /250ml 03-2015 by the USP….100mg FID Firm is Magnesium GMP compliant GluconateUSP… …..10mg Sodium Salicylate BP…….7mg Nicotinamide B.P…..0.3mg

Minutes for 254th Registration Board Meeting 292

Caffeine……10m g Boric Acid….10mg NSAID, Supplements etc Manufacturer’s Specifications 149. -do- Pri-Kanasyn 10 Form-5 ______Approved. Injection 01-12-2011 Condition will be mentioned in Each ml vide diary no. registration letter that firm will contains:- 423 Rs.8000 Kanacon purchase and perform installation Kanamycin as & 31-07-2013 Injection by and operational Sulphate……100 diary no. 977 Vetcon. qualifications of TOC analyser and mg Rs.12000 liquid particle Aminoglycoside Decontrolled/ counter in six months time USP 50ml Specifications 150. -do- Atropri Injection Form-5 ______Approved. Each ml 01-12-2011 Condition will be mentioned in contains:- vide diary no. registration letter that firm will Atropine as 413 Rs.8000 Atrovet purchase and perform installation sulphate………… & 21-07-2013 Injection by and operational .1mg diary no. 973 Selmore. qualifications of TOC analyser and Antimuscrinic Rs.12000 liquid particle USP Decontrolled counter in six months time Specifications /25ml 151. M/s A & K Amproak Powder Form 5 ______Pharmaceutic Each 100gm 11-03-2011 Approved al, 94-A, powder contains:- diary # 103 Punjab Small Amprolium Rs.8000 R&I Amprovil Industrial HCl…..90gm & Rs.12000 Powder by M/s Estate, Coccidostat vide diary # Simens Sargodha Manufacturer’s 216 dated 19- Road, Specifications 03-2014 Faisalabad. Decontrolled /100gm, 500gm, 1Kg, 2.5Kg, &5Kg.

152. -do- Amicin Powder Form 5 ______Each 100gm 11-03-2011 Approved powder contains:- diary # 107 Neomycin Rs.8000 R&I Nordcap- Sulphate & Rs.12000 Neomycin72% …..72gm vide diary # WS Powder by Antibacterial 217 dated 19- M/s Nordcap Manufacturer’s 03-2014

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Specifications Decontrolled /100gm, 500gm, 1Kg, 2.5Kg, &5Kg.

153. -do- Xedo-50 Powder Form 5 ______Each 100gm 11-03-2011 Approved powder contains:- diary # 109 Doxycycline Rs.8000 R&I Seldox Powder Hyclate & Rs.12000 by M/s Selmore …..50gm vide diary # Pharma Antibacterial 215 dated 19- Manufacturer’s 03-2014 Specifications Decontrolled /100gm, 500gm, 1Kg, 2.5Kg, &5Kg.

154. -do- Pure-T Powder Form 5 ______Deferred for Each 100gm 11-03-2011  Finished product specifications powder contains:- diary # 106 are not provided. Tylosine Tartratel Rs.8000 R&I The firm has  The firm has applied 100% as …..100gm & Rs.12000 provided the formulation which requires Antibacterial vide diary # reference of justification Require to be 218 dated 19- Tylocure by  Calculations in salt and base are provided 03-2014 M/s M.A Kamil not provided. Decontrolled Pharma  Commitment as per the decision /100gm, of Board is not provided. 500gm, 1Kg,  Outline method of manufacture 2.5Kg, &5Kg. Last fresh is not provided. inspection  Complete description of report is not formulation is not provided. provided.  The firm has appointed DVM as microbiologist. 155. -do- Cocci-No Powder Form 5 ______Deferred for Each 1000gm 11-03-2011  Finished product specifications powder contains:- diary # 102 are not provided. Sulphaquinoxalin Rs.8000 R&I The firm has  Calculations in salt and base are e & Rs.12000 provided the not provided. Sodium….140gm vide diary # reference of  Last inspection report conducted Diaveridine 221 dated 19- Doxy Gold within period of 1 year is not HCl…35gm 03-2014 which require to provided. Vitamin Decontrolled be verified  Commitment as per the decision A…..2000000IU /100gm, of Board is not provided. Vitamin 500gm, 1Kg,  Outline method of manufacture is K3…..4gm 2.5Kg, &5Kg. Last fresh not provided. Antibacterial inspection  Complete description of

Minutes for 254th Registration Board Meeting 294

Require to be report is not formulation is not provided. provided provided.  The firm has appointed DVM as microbiologist. 156. -do- Fenil Liquid Form 5 ______Each 100ml 11-03-2011 Approved liquid contains:- diary # 108 Florfenicol….10g Rs.8000 R&I Naflor liquid by m & Rs.12000 M/s Nawan Antibacterial vide diary # Manufacturer’s 219 dated 19- Specifications 03-2014 Decontrolled /100ml, 500ml, 1Liter, 2.5Liter, 157. -do- Penmox Liquid Form 5 Me to require to Deferred for Each 100ml 11-03-2011 be verified  Finished product specifications liquid contains:- diary # 105 are not provided. Cenoxine….7.5g Rs.8000 R&I  Calculations in salt and base are m & Rs.12000 not provided. Trimethoprim… vide diary # Last fresh  Last inspection report conducted ….2.5gm 220 dated 19- inspection within period of 1 year is not Sulphamethoxypy 03-2014 report is not provided. ridazine…….7.5g Decontrolled provided.  Commitment as per the decision m /100ml, of Board is not provided. Sulfamethazine… 500ml, 1Liter,  Outline method of manufacture is ..5gm 2.5Liter, not provided. Antibacterial  Complete description of Require to be formulation is not provided. provided  The firm has appointed DVM as microbiologist.

158. M/s Zakfas Rectin-D.S Form 5 ______Deferred for Pharmaceutic Injection 23-06-2011  Finished product specifications als (Pvt) Ltd, Each ml diary # 188 are not provided. 12-Km, contains:- Rs.8000 R&I Require to be  Calculations in salt and base are Bosan Road, Ivermectin….12 & Rs.12000 verified not provided. Multan mg vide diary #  Last inspection report conducted Anthelmintic 79 dated 11- within period of 1 year is not Require to be 09-2013 Last fresh provided. provided Decontrolled inspection  Commitment as per the decision /10ml, 30ml, report is not of Board is not provided. 50ml, 100ml, provided.  Outline method of manufacture 500ml, is not provided.  Complete description of formulation is not provided.

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 The firm has submitted single page stability data without any supporting documents.  Formulation requires justifications as no buffering agents are added to stabilize the formulation.  Only one volume requires to be applied per application as per the decision of Board.

159. -do- Tolfen Forte Form 5 ______Deferred for Injection 23-06-2011  Finished product specifications Each ml diary # 187 are not provided. contains:- Rs.8000 R&I Require to be  Calculations in salt and base are Tolfenamic & Rs.12000 verified not provided. acid….80mg vide diary #  Last inspection report conducted Analgesic 77 dated 11- within period of 1 year is not Require to be 09-2013 Last fresh provided. provided Decontrolled inspection  Commitment as per the decision /10ml, 20ml, report is not of Board is not provided. 50ml, 100ml, provided.  Outline method of manufacture is not provided.  Complete description of formulation is not provided.  The firm has submitted single page stability data without any supporting documents.  Formulation requires justifications as no buffering agents are added to stabilize the formulation. 160. -do- Tolfen Injection Form 5 ______Deferred for Each ml 23-06-2011  Finished product specifications contains:- diary # 190 are not provided. Tolfenamic Rs.8000 R&I Require to be  Calculations in salt and base are acid….20mg & Rs.12000 verified not provided. Analgesic vide diary #  Last inspection report conducted Require to be 72 dated 11- within period of 1 year is not provided 09-2013 Last fresh provided. Decontrolled inspection  Commitment as per the decision /10ml, 20ml, report is not of Board is not provided. 50ml, 100ml, provided.  Outline method of manufacture is not provided.  Complete description of formulation is not provided.

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 The firm has submitted single page stability data without any supporting documents.  Formulation requires justifications as no buffering agents are added to stabilize the formulation. 161. -do- Feniras Oral Form 5 ______Deferred for Solution 23-06-2011  Finished product specifications Each ml diary # 189 are not provided. contains:- Rs.8000 R&I Require to be  Calculations in salt and base are Florfenicol…… & Rs.12000 verified not provided. ….100mg vide diary #  Last inspection report conducted Antibacterial 78 dated 11- within period of 1 year is not Require to be 09-2013 Last fresh provided. provided Decontrolled inspection  Commitment as per the decision /100ml, report is not of Board is not provided. 150ml, provided.  Outline method of manufacture 250ml, is not provided. 500ml,  Complete description of 1000ml, formulation is not provided. 2500ml,  The firm has submitted single page stability data without any supporting documents.  Formulation requires justifications as no buffering agents are added to stabilize the formulation. 162. -do- TMO Powder 100 Form 5 ______Deferred for Each 1000gm 23-06-2011  Finished product specifications contains:- diary # 186 are not provided. Oxytetracycline Rs.8000 R&I Require to be  Calculations in salt and base are HCl……….150m & Rs.12000 verified not provided. g vide diary #  Last inspection report conducted Neomycin 76 dated 11- within period of 1 year is not Sulphate…60gm 09-2013 Last fresh provided. Furaltadone Decontrolled inspection  Commitment as per the decision HCl…..150gm /100gm, report is not of Board is not provided. Antibacterial 500gm, 1kg provided.  Outline method of manufacture Require to be is not provided. provided  Complete description of formulation is not provided.  The firm has submitted single page stability data without any supporting documents.  Formulation requires

Minutes for 254th Registration Board Meeting 297

justifications as no buffering agents are added to stabilize the formulation. 163. M/s S.J & G. Rexa-Plus Oral Form 5 ______Deferred for Fazul Ellahie Solution 22-08-2011  Finished product specifications (Pvt) Ltd, Each ml diary # ____ are not provided. Karachi contains:- Rs.8000 R&I Naflor Solution  Fee require to be verified. Florfenicol……1 Photocopy is by M/s Nawan  Dossier is a duplicate require to 00mg attached be verified. Antibacterial require to be  Finished product specifications Require to be verified & Last fresh are not provided. provided Rs.12000 vide inspection  Last inspection report conducted diary # 870 report is not within period of 1 year is not dated 24-07- provided. provided. 2013  Commitment as per the decision Decontrolled of Board is not provided. /100ml,  Outline method of manufacture 250ml, is not provided. 500ml, &  Complete description of 1Litre. formulation is not provided. 164. -do- Rexa-Plus Oral Form 5 ______Deferred for Solution 22-08-2011  Application is a new molecule Each ml diary # ____ require to be applied on contains:- Rs.15000 Naflor Solution Form5D. Abamectin……1 R&I by M/s Nawan  Finished product specifications 0mg Photocopy is are not provided. Anthelmintic attached  Fee require to be verified. Require to be require to be Last fresh  Dossier is a duplicate require to provided verified & inspection be verified. Rs.35000 vide report is not  Finished product specifications diary # 869 provided. are not provided. dated 24-07-  Last inspection report 2013 conducted within period of 1 Decontrolled year is not provided. /20ml, 100ml,  Commitment as per the decision 500ml, & of Board is not provided. 1Litre.  Outline method of manufacture is not provided.  Complete description of formulation is not provided. 165. M/s Mallard Fai-Plus Oral Form 5 ______Deferred for Pharmaceutic Solution 21-09-2011  Finished product specifications als (Pvt) Ltd, Each ml diary #134 are not provided. 23 Km, contains:- Rs.8000 R&I Ricozole-C  Finished product specifications Lahore Road, Ricobendazole… & Rs.12000 Solution by M/s are not provided. Multan. …40mg vide diary # Selmore but it is  Firm has provided the stability

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Sodium 940 dated 30- not in the same data but it is single page and Selinite….0.366m 07-2013 formulation incomplete. g Decontrolled require to be  Last inspection report conducted Cobalt /100ml, confirmed within period of 1 year is not Sulphate….0.833 150ml, provided. mg 250ml,  Commitment as per the decision Zinc 500ml, 1Litre Last fresh of Board is not provided. Sulphate…2.5mg & 2.5Litre. inspection  Outline method of manufacture Anthelmentic… report is not is not provided. …. provided.  Complete description of Require to be formulation is not provided. provided 166. -do- Floro 25% Oral Form 5 ______Deferred for Solution 21-09-2011  Finished product specifications Each ml diary #------are not provided. contains:- Rs.8000 R&I Not provided  Firm has provided the stability Florfenicol……2 photocopy is data but it is single page and 50mg provided& incomplete. Antibiotic Rs.12000 vide Last fresh  Last inspection report conducted Require to be diary # 957 inspection within period of 1 year is not provided dated 30-07- report is not provided. 2013 provided.  Commitment as per the decision Decontrolled of Board is not provided. /50ml, 100ml,  Outline method of manufacture 150ml, is not provided. 250ml, 500ml, 1Litre & 2.5Litre. 167. -do- Renyl-Plus Oral Form 5 ______Deferred for powder 21-09-2011  Finished product specifications Each 100gm diary # 133 are not provided. contains:- Rs.8000 R&I The firm has  Last inspection report conducted Ammonium & Rs.12000 provided the within period of 1 year is not Chloride……50g vide diary # reference of provided. m 939 dated 30- Renal plus but  Commitment as per the decision Magnesium 07-2013 is not same. of Board is not provided. Sulphate…25gm Decontrolled  Outline method of manufacture Sodium /100gm, is not provided. Sulphate…..20gm 250gm, Last fresh  The firm has provided the Sorbitol….5gm 500gm, 1kg & inspection incomplete stability data. Antibacterial 5kg. report is not  Complete description of Require to be provided. formulation is not provided. provided 168. -do- Linco 44 Oral Form 5 ______Deferred for powder 21-09-2011  Finished product specifications Each 1000gm diary # 211 are not provided. contains:- Rs.8000 R&I Lincomix 44 by  Last inspection report conducted Lincomycin & Rs.12000 m/s Pfizer

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HCl……44gm vide diary # within period of 1 year is not Antibiotic 949 dated 30- provided. Require to be 07-2013 Last fresh  Commitment as per the decision provided Decontrolled/ inspection of Board is not provided. 1kg, 2.5kg, report is not  Outline method of manufacture 5kg, 10kg, provided. is not provided. 20kg, & 25kg.  The firm has provided the incomplete stability data. 169. -do- Virgi Mix Oral Form 5 ______Deffered for powder ------diary  Finished product specifications Each 1000gm # ---- Rs.----- are not provided. contains:- R&I Require  Last inspection report conducted Vitamin to be within period of 1 year is not D3……2gm provided & Last fresh provided. L-Lysine….25gm Rs.12000 vide inspection  Commitment as per the decision Vitamin E….9gm diary # 941 report is not of Board is not provided. DL- dated 30-07- provided.  Outline method of manufacture Methionine…..50 2013 is not provided. gm Decontrolled/  The firm has provided the Choline 1kg, 2.5kg, incomplete stability data. Chloride….100g 5kg, 10kg, & m 25kg. The Board also requested to QA Virginiamycin… Division to provide updated status …12gm of GMP compliance of the firm. Antibiotic & amino acids Require to be provided

Human Products 170. M/s Hygeia B-Cure Form-5 ______Deferred for Pharmaceutical Injection 16-06-2011,  Finish product specifications are s, Each 3ml diary No2318 Neuroxol not provided. 295Industrial contains:- Rs.8000 & Injection by  The firm has mentioned 3ml at Triangles, Vitamin 20-02-2013 M/s Medicaids one place and 1m at others. Kahuta Road, B1……100mg diary No. 415 Pharmaceuticals  The firm has mentioned RO Islamabad. Vitamin Rs.12000 system in the dossier, however B6…….100mg Only distillation unit is required for Vitamin Photocopies WFI. B12…..1000mg are attached.  Last inspection conducted Vitamin B As per within the period of 1 year is not Complex SRO/3ml provided. ______ampoule  Original fee receipt of 12000 is not attached.  Form-5 is incomplete from serial #15 to 18.  Manufacturing method is not

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provided.  Commitment as per decision of RB is require to be submitted.

171. -do- Esoton-40mg Form-5 ______Deferred for Tablet 16-06-2011,  Complete description of the Each tablet diary No1211 The firm has tablet is not provided. contains Rs.8000 & provided the  Calculations in base & salt is not Esomeprazole… 20-02-2013 reference of provided. .40mg diary No. 415 Somezol 40mg  International status is not PPI Rs.12000 tablet by M/s provided by the firm. ______Only Bosch but this  Outline method of manufacture Photocopies is in capsule is not provided. are attached. form.  Last inspection conducted As per within the period of 1 year is not SRO/30,s provided.  Original fee receipt of 12000 is not attached.  Commitment as per decision of RB is require to be submitted.

172. -do- Fena.C Tablet Form-5 ______Deferred for Each tablet 16-06-2011,  Complete description of the contains diary No1203 Omnidol tablet tablet is not provided. Paracetamol Rs.8000 & M/s ???  Calculations in base & salt is not (B.P)….500mg 20-02-2013 provided. Caffeine……65 diary No. 415  International status is not mg Rs.12000 provided by the firm. Chlorphenerami Only  Outline method of manufacture ne Maleate Photocopies is not provided. Analgesic are attached.  Last inspection conducted ______As per within the period of 1 year is not SRO/30,s provided.  Original fee receipt of 12000 is not attached.  Commitment as per decision of RB is require to be submitted.

173. -do- Hatide Injection Form-5 ______Deferred for Each ml Require to be  Complete description of the contains verified as not Dexa tablet M/s tablet is not provided. Octreotide as endorsed by ???  Section approval as the drug is Acetate….0.05 STO & 20-02- cytostatic used in the treatment mg 2013 diary of cancers. Cytostatics No. 415

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______Rs.12000  Calculations in base & salt is not Only provided. Photocopies  International status is not are attached. provided by the firm. As per  Outline method of manufacture SRO/30,s is not provided.  Last inspection conducted within the period of 1 year is not provided.  Original fee receipt of 12000 is not attached.  Commitment as per decision of RB is require to be submitted.

174. -do- S-Mether Form-5 ______Deferred for Tablets 16-06-2011  In the storage conditions the firm Each tablet diary # 1195 has mentioned 25-80 C contains:- & 20-02-2013  Complete description of the Artmether……. diary No. 415 tablet is not provided. 80mg Rs.12000  International status is not Lumefantriene Only provided by the firm. ….480mg Photocopies  Outline method of manufacture Anti-malarial are attached. is not provided. ______As per SRO  Last inspection conducted within the period of 1 year is not provided.  Original fee receipt of 12000 is not attached.  Commitment as per decision of RB is require to be submitted.

175. M/s Surge Neofen Form-5D FDA. Caldolor Deferred for completion of Laboratories Injection 17-06-2010 800mg/8ml application as under:- (Pvt) Ltd, 10- 800mg/8ml diary #_____ Km, Each 8ml Photocopy& As per the decision of RB in its 251st Faisalabad contains:- 15-08-2013 meeting following is required:- Road, Ibuprofen……. diary No.____ Sheikhupura. 800mg Photocopy  Certificate of Analysis of API. Analgesic Rs.35000 Manufacturer’s Only  Approval of API by specifications Photocopies regulatory authority of country are attached. of origin or GMP certificate of Rs.540 per API manufacturer issued by regulatory authority of country ampoule of origin.

 Manufacturer will follow

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Drug Specification Rules, 1986.

 Protocols followed for conduction of stability study and details of tests.

 Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.

 Documents confirming import of API etc.

 All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.

 Shelf life of two years shall be granted based upon the results 06 month accelerated and real time stability study data.  Commitment to continue real time stability study till assigned shelf life of the product. 176. -do- Neofen Form-5D FDA. Caldolor As per the decision of RB in its 251st Injection 17-06-2010 400mg/4ml meeting following is required:- 400mg/4ml diary #_____ Each 4ml Photocopy&  Certificate of Analysis of API. contains:- 15-08-2013 Ibuprofen……. diary No.____  Approval of API by 400mg Photocopy regulatory authority of country Analgesic Rs.35000 of origin or GMP certificate of Manufacturer’s Only API manufacturer issued by regulatory authority of country specifications Photocopies of origin. are attached. Rs.435 per  Manufacturer will follow ampoule Drug Specification Rules, 1986.

 Protocols followed for conduction of stability study and details of tests.

 Data of 03 batches will be

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supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.

 Documents confirming import of API etc.

 All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.

 Shelf life of two years shall be granted based upon the results 06 month accelerated and real time stability study data. Commitment to continue real time stability study till assigned shelf life of the product.

177. -do- Neofen Form-5D The product is International availability in same Injection 17-06-2010 not confirmed strength and dosage form is not 200mg/2ml diary #_____ in this volume confirmed. Each 2ml Photocopy& in FDA, require As per the decision of RB in its 251st contains:- 15-08-2013 to be submitted. meeting following is required:- Ibuprofen……. diary No.____ 200mg Photocopy  Certificate of Analysis of API. Analgesic Rs.35000 Manufacturer’s Only  Approval of API by specifications Photocopies regulatory authority of country are attached. of origin or GMP certificate of Rs.435 per API manufacturer issued by regulatory authority of country ampoule of origin.

 Manufacturer will follow Drug Specification Rules, 1986.

 Protocols followed for conduction of stability study and details of tests.

 Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory

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reports, data sheets etc.

 Documents confirming import of API etc.

 All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.

 Shelf life of two years shall be granted based upon the results 06 month accelerated and real time stability study data.  Commitment to continue real time stability study till assigned shelf life of the product.

178. -do- Saltide Form-5 . Deferred for Nebuliser 24-10-2013  The firm has applied the product Solution diary #612 as priority as new section, 5mg/2.5ml As per SRO however, in the letter issued Each 2.5ml from licensing it seems that this contains:- is the amendment, not new Salbutamol (as section. Clarification from Sulphate) eq to licensing division is required. salbutamol……  Firm has applied on Form 5 , ….5mg only accelerated stability data is Selective B2 attached without any supporting Agonist documents like chromatograms, Manufacturer’s raw data etc. specifications  International availability is required to be provided.  Internationally, in UK this product is presented in the form of plastic bottles.

179. -do- Saltide Form-5 . Deferred for Nebuliser 24-10-2013  The firm has applied the Solution diary #613 product as priority as new 2.5mg/2.5ml As per SRO section, however, in the letter Each 2.5ml issued from licensing it seems contains:- that this is the amendment, not Salbutamol (as new section. Clarification from Sulphate) eq to licensing division is required salbutamol……  Firm has applied on Form 5 ,

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….2.5mg only accelerated stability data Selective B2 is attached without any Agonist supporting documents like Manufacturer’s chromatograms, raw data etc. specifications  International availability is required to be provided.  Internationally, in UK this product is presented in the form of plastic bottles.

180. -do- Tolbin Form-5 . Deferred for Nebuliser 06-11-2013  Clarification regarding; the firm Solution diary #737 has applied the product as 5mg/2ml As per SRO priority as new section, however, Each 2ml in the letter issued from licensing contains:- it seems that this is the Terbutaline (as amendment, not new section. Sulphate) eq to Clarification from licensing Terbutaline…… division is required. ….5mg  Firm has applied on Form 5 , Selective B2 only accelerated stability data is Agonist attached without any supporting Manufacturer’s documents like chromatograms, specifications raw data etc.  International availability is required to be provided.  Internationally, in UK this product is presented in the form of plastic bottles.

181. -do- Iprasol Form-5 . Deferred for Nebuliser 24-10-2013  Clarification regarding; the firm Solution diary #614 has applied the product as 250mcg/1ml As per SRO priority as new section, however, Each 1ml in the letter issued from licensing contains:- it seems that this is the Ipratropium amendment, not new section. Bromidel…… Clarification from licensing ……250mcg division is required. Anticholinergic  Firm has applied on Form 5 , Manufacturer’s only accelerated stability data is specifications attached without any supporting documents like chromatograms, raw data etc.  International availability is required to be provided.  Internationally, in UK this

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product is presented in the form of plastic bottles.

182. -do- Iprasol Form-5 . Deferred for Nebuliser 24-10-2013  The clarification regarding the Solution diary #615 firm has applied the product as 500mcg/2ml As per SRO priority as new section, however, Each 2ml in the letter issued from licensing contains:- it seems that this is the Ipratropium amendment, not new section. Bromidel…… Clarification from licensing ……500mcg division is required. Anticholinergic  Firm has applied on Form 5 , Manufacturer’s only accelerated stability data is specifications attached without any supporting documents like chromatograms, raw data etc.  International availability is required to be provided.

183. M/s Lisko Amarox Tablet Form-5 FDA Amaryl Pakistan (Pvt) 1mg 03-03-2010 1mg by M/s Approved Ltd, L-10-D Each tablet Rs.8000 & Sanofi Aventis Block-21, contains:- 14-04-2014 Shaheed Glimepride…… Rs.12000 Amaryl Tablet Rashid Minhas .. 1mg verified by 1, 2, 3 & 4mg Road, F.B, Antidiabetic/Sul Statistical by M/s Sanofi Industrial phonylurea Officer. Area, Karachi. Manufacturer’s As per SRO specifications The GMP of the firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015 184. -do- Amarox Tablet Form-5 FDA Amaryl 2mg 03-03-2010 2mg by M/s Approved Each tablet Rs.8000 & Sanofi Aventis contains:- 06-05-2014 Glimepride…… Rs.12000 Amaryl Tablet .. 2mg verified by 1, 2, 3 & 4mg Antidiabetic/Sul Statistical by M/s Sanofi

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phonylurea Officer. Manufacturer’s As per SRO specifications The GMP of the firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015 185. -do- Amarox Tablet Form-5 FDA. 3mg 03-03-2010 Glimepride 3mg Approved Each tablet Rs.8000 & by M/s contains:- 06-05-2014 Ranbaxy Glimepride…… Rs.12000 .. 3mg verified by Amaryl Tablet Antidiabetic/Sul Statistical 1, 2, 3 & 4mg phonylurea Officer. by M/s Sanofi Manufacturer’s As per SRO specifications

The GMP of the firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015 186. -do- Amarox Tablet Form-5 FDA Amaryl 4mg 03-03-2010 3mg by M/s Approved Each tablet Rs.8000 & Sanofi Aventis contains:- 06-05-2014 Glimepride…… Rs.12000 Amaryl Tablet .. 4mg verified by 1, 2, 3 & 4mg Antidiabetic/Sul Statistical by M/s Sanofi phonylurea Officer. Manufacturer’s As per SRO specifications The GMP of the firm is satisfactory and panel recommended for the renewal vide inspection

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conducted dated 12-03-2015

187. -do- Preline Capsule Form 5 LYRICA 50mg Capsules (25, Approved Rs.8000/- 50, 75, 100, Capsule for 25-04-2009 & 150,200, 225 oral use Rs.12000/- and 300mg) Each Capsule 06-05-2014 US FDA Contains: Verified by GABICA Pregabalin Statistical Capsules (50, …50mg Officer. 75, 100, 150 and (Antiepileptic) 300mg) Rs.17.50/Caps Getz Manufacturers ule 14,s The GMP of the specifications firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015. 188. -do- Preline Capsule Form 5 LYRICA 75mg Capsules (25, Approved Rs.8000/- 50, 75, 100, Capsule for 25-04-2009 150,200, 225 oral use & and 300mg) Each Capsule Rs.12000/- US FDA Contains: 06-05-2014 GABICA Pregabalin…… Verified by Capsules (50, …..…75mg Statistical 75, 100, 150 Officer. and (Antiepileptic) 300mg) Rs.23/Capsule Getz Manufacturers 14 The GMP of the specifications firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015

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189. -do- Preline Capsule Form 5 LYRICA 150mg Capsules (25, Approved Rs.8000/- 50, 75, 100, Capsule for 25-04-2009 & 150,200, 225 oral use Rs.12000/- and 300mg) Each Capsule 06-05-2014 US FDA Contains: Verified by GABICA Pregabalin…… Statistical Capsules (50, ……150mg Officer. 75, 100, 150 and (Antiepileptic) Rs. 32.50/- 300mg) Capsule 14 Getz Manufacturers The GMP of the specifications firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015 190. -do- Preline Capsule Form 5 LYRICA 100mg Capsules (25, Approved Rs.8000/- 50, 75, 100, Capsule for 25-04-2009 & 150,200, 225 oral use Rs.12000/-06- and 300mg) Each Capsule 05-2014 US FDA Contains: Verified by GABICA Pregabalin…… Statistical Capsules (50, …..100mg Officer. 75, 100, 150 and (Antiepileptic) 300mg) Rs.28.50/- Getz Manufacturers Capsule 14 The GMP of the specifications firm is satisfactory and panel recommended for the renewal vide inspection conducted dated 12-03-2015 191. M/s Getz Getformin M- Form-5 Pharma (Pvt) SR Tablet 31-03-2011 Approved Ltd, 29-30/27 Each double diary #501 Korangi layered tablet Rs.8000 Amaryl M by Industrial contains:- 31-07-2013 M/s Sanofi Area, Karachi. Glimepiride… Rs.12000 Aventis

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…1mg endorsed by 1/500mg & Metformin statistical 2/500mg HCl……500mg officer. tablets. Oral Rs.11.25/table Firm is GMP Antidiabetic t & for the compliant as Manufacturer’s pack of 20 per inspection Specifications tablets Rs.225 dated 11-12- & 11.33/tablet 2014 & for the pack of 30 tablets Rs.340 192. -do- Getformin SR Form-5D Tablet 31-03-2011 Approved Each double diary #500 Amaryl M by layered tablet Rs.8000 & M/s Sanofi contains:- 30-07-2013 Aventis Glimepiride… Rs.12000 1/500mg & …2mg endorsed by 2/500mg tablets Metformin statistical Firm is GMP HCl……500mg officer. compliant as Oral Rs.21/tablet & per inspection Antidiabetic for the pack dated 11-12- Manufacturer’s of 20 tablets 2014 Specifications Rs.420 & 21/tablet & for the pack of 30 tablets Rs.630

193. -do- Advantec Tablet Form-5D MHRA Each tablet 07-03-2011 approved Approved contains:- diary #135 (KRKA, Candesartan as Rs.15000 & Solvenia) Cilexetil..…32 30-07-2013 mg Rs.35000 Skygen Neo Hydrochlorthiaz endorsed by tablet ide……12.5mg statistical Reg#067268 by Antihypertensiv officer. M/s Genix e Rs.31.5/tablet Manufacturer’s & for the pack Specifications of 14 tablets Rs.441 & Rs.31.5/tablet & for the pack of 20 tablets Rs.630

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194. M/s ARP (Pvt) Purome 500mg Form-5 Require to be Deferred for provision of Ltd, Plot No. Injection I.V 30-07-2011 provided  Finished product specifications. 12 & 12A, Each vial diary #_____  Calculations in salt and base. Street No. W- contains:- Rs.8000 & Iprome  Commitment as per decision of 3, National Cefpirome as 26-07-2013, Injection Registration Board need to be Industrial Zone Sulphate……. vide diary # 500mg, 1gm by submitted. (RCCI), …..500mg 1860 M/s Ipram  The firm has mentioned both IM Rawat, Cephalosporin Rs.12000 Pharma and IV routes only one need to Islamabad. Specifications As per SRO be selected. require to be provided 195. -do- Purome 1gm Form-5 Require to be Deferred for Injection I.V 30-07-2011 provided  Finished product specifications Each vial diary #_____ are not provided. contains:- Rs.8000 & Iprome  Calculations in salt and base are Cefpirome as 26-07-2013, Injection not provided. Sulphate……. vide diary # 500mg, 1gm by  Commitment as per decision of …..1g 1859 M/s Ipram Registration Board need to be Cephalosporin Rs.12000 Pharma submitted. Specifications As per SRO  The firm has mentioned both IM require to be and IV routes only one need to provided be selected.

196. -do- Purox 250mg Form-5 BNF Zinacef Injection 30-07-2011 Injection 250mg Approved I.M/I.V diary #_____ by M/s GSK. Each vial Rs.8000 & contains:- 26-07-2013, Alfur 250mg, Cefuroxime vide diary # 750mg Injection Sodium eq to 1863 by M/s Albro Cefuroxime… Rs.12000 Pharma ….…..250mg As per SRO Cephalosporin USP Specifications 197. -do- Purox 750mg Form-5 FDA. Injection I.V 30-07-2011 Cefuroxime Approved Each vial diary #_____ Sodium contains:- Rs.8000 & Injection 750mg Cefuroxime 26-07-2013, as base Sodium eq to vide diary # Cefuroxime… 1865 Alfur 250mg, ….…..750mg Rs.12000 750mg Injection Cephalosporin As per SRO by M/s Albro USP Pharma Specifications

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198. -do- Purox 1.5gm Form-5 FDA. Injection I.V 30-07-2011 Cefuroxime Approved Each vial diary #_____ Sodium contains:- Rs.8000 & Injection 1.5gm Cefuroxime 26-07-2013, as base Sodium eq to vide diary # Cefuroxime… 1861 Avefro ….…..1.5gm Rs.12000 Injection 1.5gm Cephalosporin As per SRO by M/s Aventek USP Pharma Specifications 199. -do- Radox Form-5 MHRA. 40mg/5ml Dry 30-07-2011 Cefpodoxime Approved Suspension diary #_____ 40mg/5ml dry Each 5ml when Rs.8000 & suspension by reconstituted 26-07-2013, M/s Aurobindo contains:- vide diary # Pharma Cefpodoxime 1864 Proxetil eq to Rs.12000 Avedoxime dry Cefpodoxime… As per SRO suspension ….…..40mg 40mg/5ml by Cephalosporin M/s Aventek USP Pharma Specifications 200. -do- Purox Form-5 MHRA. Zinnat 125mg/5ml Dry 30-07-2011 125mg/5ml as Approved Suspension diary #_____ base dry Each 5ml when Rs.8000 & suspension by reconstituted 26-07-2013, M/s GSK UK contains:- vide diary # Cefuroxime 1867 Avefro dry Axetil eq to Rs.12000 suspension Cefuroxime… As per SRO 125mg/5ml by ….…..125mg M/s Aventek Cephalosporin Pharma USP Specifications 201. M/s Convell Cidol-L Syrup Form-5 Deferred for Laboratories, 2.5mg/5ml 30-09-2010  Finished product and raw Saidu Sharif, Each 5ml diary #124 PIP Syp material specifications are not Swat. contains:- Rs.8000 & 2.5mg/5ml by provided. Levocetrizine as Proof of M/s Unison  International availability not 2HCl differential provided. …….…..2.5mg fee of  Commitment as per decision of Anti-Histamine Rs.12000 Registration Board need to be Specifications need to be submitted. require to be submitted.  Manufacturing method is not submitted. Rs.40/Require

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to be provided. provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  In the types of containers/packing firm is claiming capsules instead of syrup which requires clarification.  Volume of unit pack is not mentioned.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the DRAP. 202. -do- Cidol-L tablet Form-5 Deferred for 5mg 30-09-2010  Finished product and raw Each tablet diary #125 Levocetrin material specifications are not contains:- Rs.8000 & Tablet 5mg by provided. Levocetrizine Proof of M/s Biorex  International availability not …….…..5mg differential provided. Anti-Histamine fee of  Commitment as per decision of Specifications Rs.12000 Registration Board need to be require to be need to be submitted. submitted. submitted.  The firm is claiming different Rs.40/Require brand names at different places to be of the dossier. provided.  Manufacturing method is not provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  In the types of

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containers/packing firm is claiming capsules instead of syrup which requires clarification.  Volume of unit pack is not mentioned.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the DRAP. 203. -do- Mount 5mg Form-5 Deferred for Tablet 30-09-2010  Finished product and raw Each tablet diary #119 Aerokast tablet material specifications are not contains:- Rs.8000 & 5mg by M/s provided. Montelukast as Proof of Barrett  International availability not Sodium eq to differential Hodgson provided. Montelukast fee of  Description of the tablet is not Acid Rs.12000 provided. …….…...5mg need to be  Firm is claiming montelukast Leukotriene submitted. acid which requires clarification. Receptor Rs.13.30/Tabl  Commitment as per decision of Antagonist et. Registration Board need to be Specifications submitted. require to be  Manufacturing method is not submitted. provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.

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 International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the DRAP. 204. -do- Mount 10mg Form-5 Deferred for Tablet Dossier is a  Finished product and raw Each tablet photocopy Aerokast tablet material specifications are not contains:- original 10mg by M/s provided. Montelukast as require to be Barrett  International availability not Sodium eq to submitted. Hodgson provided. Montelukast Require to be  Description of the tablet is not Acid provided. provided. …….…...10mg  Firm is claiming montelukast Leukotriene acid which requires clarification. Receptor  Commitment as per decision of Antagonist Registration Board need to be Specifications submitted. require to be  Manufacturing method is not submitted. provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  Complete dossier is a photocopy.  The firm has submitted replies in the official file cover of the DRAP. 205. -do- Fezet 60mg Form-5 Deferred for Tablet 30-09-2010  Finished product and raw Each tablet diary #126 Adine 60mg material specifications are not contains:- Rs.8000 & tablet by M/s provided. Fexofenadine Proof of Pfizer

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HCL…….60mg differential  International availability not Antihistamine fee of provided. Specifications Rs.12000  Description of the tablet is not require to be need to be provided. submitted. submitted.  Commitment as per decision of Rs.6.20/Table Registration Board need to be t. submitted.  Manufacturing method is not provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  In the types of containers/packing firm is claiming capsules instead of syrup which requires clarification.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the DRAP. 206. -do- Redest Form-5 Deferred for Chewable tablet Photocopy  Finished product and raw 100mg original need Require to be material specifications are not Each chewable to be submitted provided. tablet contains:- submitted.  International availability not Iron III provided. Hydroxide  Description of the tablet is not Polymaltose provided. complex eq to  Commitment as per decision of elemental Registration Board need to be Iron…….100m submitted. g  Manufacturing method is not Haematinic provided. Specifications  Calculations in salt and base

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require to be form are not provided. submitted.  Last inspection report conducted within the period of 1 year is not provided.  In the types of containers/packing firm is claiming capsules instead of syrup which requires clarification.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the DRAP. 207. -do- Azit 200mg dry Form-5 Deferred for suspension 30-09-2010  Finished product and raw Each 5ml diary #128 Acasia 200mg material specifications are not contains:- Rs.8000 & dry suspension provided. Azithromycin Proof of by M/s  Firm is claiming it as a syrup Dihydrate…… differential Nexpharm but actually it is a dry …200mg fee of suspension. Macrolide Rs.12000  International availability not Specifications need to be provided. require to be submitted.  Description of the tablet is not submitted. Rs.6.20/Table provided. t.  Commitment as per decision of Registration Board need to be submitted.  Manufacturing method is not provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  Water processing and environmental control is not attached at all.

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 Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the DRAP. 208. -do- Cip 750mg Form-5 Deferred for Tablet 30-09-2010  Finished product and raw Each tablet diary #123 Flinox 750mg material specifications are not contains:- Rs.8000 & tablet by M/s provided. Ciprofloxacine Proof of Polyfine  International availability not …….750mg differential provided. Quinolone fee of  Description of the tablet is not Specifications Rs.12000 provided. require to be need to be  Commitment as per decision of submitted. submitted. Registration Board need to be Rs.29.90/Tabl submitted. et.  Manufacturing method is not provided.  Calculations in salt and base form are not provided.  Last inspection report conducted within the period of 1 year is not provided.  In the types of containers/packing firm is claiming capsules instead of syrup which requires clarification.  Water processing and environmental control is not attached at all.  Name of equipments used in the production alongwith status of GMP compliance is not provided.  International availability is not provided by the firm.  Proof of submission of differential fee is not attached.  The firm has submitted replies in the official file cover of the

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DRAP.

209. M/s Kaizen Calvit-D Sachet Form-5 Deferred for Pharmaceutical Each sachet Copy of fee  Proof of Original fee s (Pvt) Ltd, E- contains:- submission of submission need to be 127-129, North Calcium Citrate Rs.20000 28- The firm has submitted. Western Maleate……25 01-2013 are submitted me to  International status need to be Industrial 00mg attached status of verified alongwith me to status. Zone, Bin Vitamin original Calcivit sachet  Commitment as per decision of Qasim, D…….400IU require to be by M/s Maple Registration Board need to be Karachi. Calcium & submitted. pharma which submitted. Vitamin As per require to be  List of equipments used in the Supplement SRO/20’s verified production of drug alongwith Manufacturer’s pack GMP compliant is not provided. Specification.  Manufacturing method is wrong requires clarification.  Finished product specifications are incomplete. 210. -do- Alfakal Tablet Form-5 Deferred for Each tablet Copy of fee  Proof of Original fee contains:- submission of submission need to be Alfacalcidol… is attached The firm has submitted. …0.5mcg original submitted me to  International status need to be Calcium require to be status of Bone- verified alongwith me to status. Carbonate..…… submitted. Care tablet by  Commitment as per decision of .1000mg As per M/s Schazoo Registration Board need to be Calcium & SRO/10’s Zaka pharma submitted. Vitamin pack which is 0.5mcg  List of equipments used in the Analogue Alfacalcidol production of drug alongwith Manufacturer’s only. GMP compliant is not provided. Specification.  Manufacturing method is wrong requires clarification.  Finished product specifications are incomplete. 211. M/s Harmann Paxyl Injection Form-5 Require to be Deferred for Pharmaceutical Each ml 24-12-2010 confirmed.  Finished product specifications Laboratories contains:- vide diary # are not provided. (Pvt) Ltd, Piroxicam……. 659 Rs.8000 Aksocam 20mg  Manufacturing method is not 16Km Multan ….20mg R&I &12-12- Injection by provided. road, Lahore. Anti- 2013 diary # M/s Akson  Commitment as per decision of inflammatory 7974 Pharma. RB is not provided. Specifications Rs.12000  International availability is not require to be Rs provided. provided 20/Injection  Fresh inspection report conducted within the period of

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one year is not provided.  As per documents attached by the firm, distillation unit require to be confirmed.  Documents are not signed by technical persons. 212. M/s Rovin Tablet Form-5 Require to be Deferred for / Standpharm 20mg 03-02-2011 confirmed.  The original fee Rs.8000 s Pakistan (Pvt) Each tablet vide diary # -- attached is a photocopy and Ltd, Lahore. contains:- - Rs.8000 Crestat tablet 12000 is original. Rosuvastatin as R&I &09-21- 20mg by M/s  Description of the tablet is Calcium…….… 2013 diary # CCL Pharma. incomplete. .20mg 1029  Finished product specifications Hypolipidaemic Rs.12000 are not provided. s Rs 40/Tablet  Commitment as per the decision Specifications of RB is not attached. require to be  Dossier is a photocopy. provided  Fresh inspection report conducted within the period of 1 year is not attached.  Outline method of manufacture is not provided.  Firm has submitted the stability data without any tem and humidity descriptions.

213. -do- Rovin Tablet Form-5 Require to be Deferred for 5mg 03-02-2011 confirmed.  The original fee Rs.8000 Each tablet vide diary # -- attached is a photocopy and contains:- - Rs.8000 Crestat tablet 12000 is original. Rosuvastatin as R&I &09-21- 5mg by M/s  Description of the tablet is Calcium…….… 2013 diary # CCL Pharma. incomplete. .5mg 1030  Finished product specifications Hypolipidaemic Rs.12000 are not provided. s Rs 20/Tablet  Commitment as per the decision Specifications of RB is not attached. require to be  Dossier is a photocopy. provided  Fresh inspection report conducted within the period of 1 year is not attached.  Outline method of manufacture is not provided.  Firm has submitted the stability data without any tem and humidity descriptions.

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214. M/s Astellas Astelexim Form-5 MHRA Deferred for Pharmaceutical Injection 11-02-2011 Cefuroxime  Finished product specifications (Pvt) Ltd, 15-C Each vial vide diary # Sodium 250mg are not provided. Industrial contains:- 09 Rs.8000 Injection.  Commitment as per the decision Estate Cefuroxime as R&I &11-02- of RB is not attached. Hayatabad, Sodium eq to 2014 diary # Alfur Injection  Fresh inspection report Peshwar. Cefuroxime… 166 Rs.12000 250mg by M/s conducted within the period of 1 ….….250mg As per SRO Albro Pharma. year is not attached. Cephalosporin  Outline method of manufacture USP is not provided. Specifications 215. M/s Wns Feild Betacam 20mg Form-5 FDA Feldene Deferred for Pharmaceutical Capsule 01-01-2011 20 mg Capsule .  Finished product specifications s, Plot # 122, Each capsule vide diary # are not provided. Block –B, contains:- 99 Rs.8000 Feldene 20 mg  Commitment as per the decision Phase V, Piroxicam Beta R&I &26-11- Capsule by M/s of RB is not attached. Industrial Cyclodextrin… 2013 diary # Pfizer.  Fresh inspection report Estate, Hattar, ….….20mg 273 Rs.12000 conducted within the period of 1 KPK. Cephalosporin As per SRO year is not attached. Manufacturer’s  Outline method of manufacture Specifications is not provided.  Internationally it is present as piroxicam only not as beta cyclodextrin, which requires clarification. 216. M/s Barrett Mobikare Plus Form-5 FDA Arthrotec Deferred for Hodgson Tablet 15-06-2010 Tablet by M/s  Double compression machine Pakistan (Pvt) Each tablet vide diary # Searle. require to be verified. Ltd, F/423, contains:- 160 Rs.8000  Commitment as per the decision SITE, Karachi. Diclofenac R&I & 21-05- Arthrotec of RB is not attached. Sodium……... 2013 diary # Tablet by M/s  Fresh inspection report ….50mg ___ Rs.12000 Pfizer. conducted within the period of 1 Misoprostol… Photocopy year is not attached. ……200mcg attached  Outline method of manufacture NSAID+Prostag As per SRO is not provided. landin analogue  Photocopy of fee Rs.12000 Manufacturer’s attached original is required. Specifications 217. M/s Linear L-Fenac 25mg Form-5 FDA Soriatane Deferred for Pharma, Plot # Capsule 25mg by M/s  Finished product specifications 18, Street # S- 02-09-2010 Stieffel are not provided. 4, National Each capsule vide diary # Acetin 25mg  Commitment as per the decision Industrial contains:- 1137 Rs.8000 capsule by M/s of RB is not submitted. Zone, Rawat, Acitretin…..25 & 17-12-2013 Genome.  Outline method of manufacture Islamabad. mg diary # 8151 is not provided. Vitamin A Rs.12000  Fresh inspection report Derivative. As per SRO conducted within the period of 1

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Finish product year is not submitted. require to be provided. 218. M/s Shawan Omeyz 40mg Form-5 Deferred for Pharmaceutical Capsule.  Finished product specifications s, Islamabad. Each capsule 01-03-2011 Omega 40mg are not provided. contains:- vide diary # by M/s  Source of pellets is not Omeprazole… 3030 Ferozsons provided. ….40mg Rs.15000 &  Commitment as per decision of PPI 19-08-2013 RB is not provided. Specifications diary # 1917  Fresh inspection report need to be Rs.5000 conducted within the period of 1 submitted. As per SRO year need to be submitted.

219. M/s UDL Azecid Capsule Form 5 FDA.Zithromax Pharmaceutical Each capsule Dy No. 806I capsule 250 mg Approved s Plot No. E-44 contains 03-08-2015, Azitek 250mg & E-45, North Azithromycin as Rs. 20,000/- by M/s Hygeia Western dehydrate eq to As Per SRO Industrial azithromycin…. Zone, Karachi. 250mg (Anomally Macrolide cases) USP Specifications 220. -d0- Xeroyn Dry Form 5 FDA. Deferred for confirmation of source Suspension Dy No. 805 Clarithromycin of granules and requisite fee Each 5ml dated 03-08- Oral Suspension contains 2015 Klaricid clarithromycin Rs 20,000 125mg/5ml granules eq to As per SRO clariyhromycin ….125mg (Anomally Macrolide cases) USP Specifications 221. Aventek A-smec Sachet Form 5 Not confirmed pharmaceutical Each Sachet (03.03.15) Smecta (Atco Approved s Lahore Contain Dy. No. 1320 Laboratories.) Dioctahedral Rs. 20000/- The product smectites……. As per DRAP was deferred in 3gm policy the 250th (Anti- meeting of the diarrhoeals) (Anomally RB for (Manufacturer’s cases) confirmation of Spec.s) International availability, However, now

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the same formulation has been approved by the board. 222. M/s Sami RITHMO Form 5 EMA: Klaricid Pharmaceutical 500mg Rs. 8,000/- (Abbott) Approved s(Pvt) Ltd, Lyophilized (30-05-2012) KLARICID Karachi powder for Rs. 12,000/- (Abbott) Injection (29-07-2013) Grant of Each Rs. 160 per additional combination vial section – Freeze pack contains: Dried Products Vial (General)(24- Clarithromycin 06-2014) Lactobionate VERY GOOD equivalent to The product Clarithromycin was deferred for … 500mg following:- (suitably Label claim of buffered) product needs (Antibiotic – clarification as Macrolide class) BNF does not B.P Specs. mention it in lactobionate form. 2. Specfications of active starting material(s) i.e., API (Active Pharmaceutical Ingredient) has been given as MS in form 5 and USP in composition and details. Clarification is required. 3. Specifications of finished product not phamacopial, while product is available in B.P. Now the firm has submitted the shortcomings.

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223. -do- TULOSIN MR Form 5 EMA: Flomax MR Deferred for source of pellets is not 0.4mg Capsules (Boehringer) provided Rs. 20,000/- FDA: Flomax Each Capsule (24-11-2014) (Boehringer) contains: vide diary # 138 Modified release New Section Tamsolin Regn. pellets of Capsule No. 050392 (Getz) Tamsulosin HCl equivalent to Grant of additional Tamsulosin HCl section – Capsule USP……. …0.4mg (General) (24-06- 2014) (Alpha-Adrenerjic VERY GOOD Blocker)

USP specs 224. -do- STEIN 150mg Form 5 Denmark : Erdotin Deferred for Capsules Rs. 8,000/- (Orion Pharma)  Original dossier as (09-04-2012) & Italy: ERDOTIN Photocopy of the Dossier is Each capsule Rs. 12,000/- (Edmond Pharma) contains: (29-07-2013) attached. Erdosteine MS DOSTIN Regn.  Photocopy of fees submitted ……..150mg Rs. 178 for 20 No. 032332 are attached. capsules (Brookes Pharma) (Mucolytic) Grant of additional SAMI’s Specs. section – Capsule (General) (24-06- 2014) VERY GOOD

225. FUNGONE 50mg Form 5 EMA: Diflucan Deferred for provision of original Capsules Rs. 8,000/- (Pfizer) challan as Photocopy of differential Each capsule (21-05-2011) contains: vide diary # 260 Diflucan Regn. No. fee 12000 is attached. Fluconazole USP & 011827 (Pfizer) ………..50mg Rs. 12,000/- (Anti-fungal) (29-07-2013) Grant of additional SAMI’s Specs. section – Capsule (General As per latest Antibiotics) (08- decision taken by 09-2014) PAC in respect VERY GOOD of usual / hardship cases

Evaluator II

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S/N Name and Brand Name Type of Form Remarks on the Remarks by Evaluator/ address of (Proprietary name + Dosage formulation (if Descion manufacturer / Form + Strength) Initial date, any) including Applicant diary International Composition status in stringent Fee including drug regulatory Pharmacological Group differential agencies / fee authorities Finished product Specification Demanded Me-too status Price / Pack size GMP status as depicted in latest inspection report (with date) by the Evaluator 226 M/s Pharmix Exon Tablet 150mg Form-5 Mydocalm by Deferred for Laboratories Tablet Dy. No: 8627 Medimpex Pharma  Commitment as per (Pvt) Ltd. 21Km Each film coated tablet contains: dated. International 251st meeting of RB. Ferozepur Road Tolperisone HCL…….150mg 22-09-2010 availability not  Last inspection Lahore. (Muscle Relaxant) Rs.8000/- provided. report. Specs not provided 30-07-2013  International Rs.12,000/- availability Rs.10/- / confirmation. Tablet  Reference for 10’s 30’s. Specification.  Average weight clarification given in specification and calculated from master formulation. 227 M/s Pharmix Spasnil Tablet 50mg Form-5 Myonal by Hilton Deferred for Laboratories Tablet Dy. No: 8626 Pharma  Commitment as per (Pvt) Ltd. 21Km Each film coated tablet contains: dated. International 251st meeting of RB. Ferozepur Road Eperisone (HCL)………….50mg 22-09-2010 availability not  Last inspection Lahore. (Anticholinergic/ Antispasmodic) Rs.8000/- provided. report. Specs not mentioned 30-07-2013  Method to determine Rs.12,000/- the related Rs.12/- / substances. Tablet  Analytical method 20’s 30’s. validation or compendia photocopy of method.  Methods for material identification and relevant tests.

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228 M/s Pharmix Vital Tablet Form-5 Oculuvit extra by Deferred for Laboratories Tablet Dy. No: 8920 Ethical Labs.  Justification of (Pvt) Ltd. 21Km Each film coated tablet contains: dated. Me too not correct Quantities of APIs Ferozepur Road Viamin B1 (Thiamine 30-09-2010 International used in master Lahore. mononitrate) Rs.8000/- availability not formulation and IPA USP……….15.00mg 30-07-2013 provided. use. Viamin B2 Rs.12,000/-  Correct Me too. (Riboflavin)...15.00mg Rs.300/-  Correct Specs. Viamin C (Ascorbic Acid) 30’s.  Atomic absorption ……500.00mg spectrophotometer Viamin A (Acetate) …5000.00 i.u for minerals. Vitamin D (Cholecalciferol D3)  Analytical method ……100.00 i.u validation or Manganese (As sulphate) compendia …1.5mg photocopy of Copper (As sulphate) …..2.00mg method. Folic Acid….……200.00mcg  Packing to be as per Selenium (As Dioxide) innovator. …..40.5mcg  Last inspection Zinc (As Oxide) ………40.00mg report is dated. (Vitamins/Minerals)  Commitment as per Specs not mentioned 251st meeting of RB.

229 M/s Pharmix Anidep Tablet 5mg Form-5 Cipralex by Deferred for Laboratories Tablet Dy. No: 8449 Lundbeck  Commitment as per (Pvt) Ltd. 21Km Each tablet contains: dated. International 251st meeting of RB. Ferozepur Road Escitalopram (MS)……..5mg 30-07-2010 availability not  Last inspection Lahore. (Selective Serotonin Reuptake Rs.8000/- provided. report. Inhibitor) 30-07-2013  Reference of Specs. Specs not provided Rs.12,000/-  Average weight Rs.150/- clarification given in Rs.285/- specification and 10’s, 20’s. calculated from master formulation.  Clarification for use of Escitalopram intead of Escitalopram oxalate. 230 M/s Pharmix Anibone Drops Form-5 Me-too not Deferred for Laboratories Oral Liquid/Syrup Dy. No: 527 provided by the  Commitment as per (Pvt) Ltd. 21Km Each ml of Drops contains: dated. firm. 251st meeting of RB. Ferozepur Road Alfacalcidol (BP)……2MCG/Ml 21-12-2010 International  Covering letter Lahore. (Vitamin D analogue) Rs.8000/- availability not shows Form-5 D 05-08-2013 provided. while fee is as per Rs.12,000/- Form-5. Rs.1150/-  Incomplete Form-5. 20ml Bottle.  International availability confirmation.

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231 M/s Pharmix Iroplex Syrup Form-5 Maltofer Syrup by Deferred for Laboratories Oral Liquid/Syrup Dy. No: 531 RG pharmaceuticals  Commitment as per (Pvt) Ltd. 21Km Each 5ml syrup contains: dated. International 251st meeting of RB. Ferozepur Road Iron (III) Hydroxide Polymaltose 21-12-2010 availability not  Last inspection Lahore. Complex eq.to elemental Rs.8000/- provided. report. Iron……….50mg 05-08-2013  International (Heamatinic) Rs.12,000/- availability Rs.110/- confirmation. Rs.205/- 60ml, 120ml Bottle. 232 M/s Hoover Goflox Tablet 320mg Form-5 Gemixa by Bosch Deferred for Pharmaceuticals Tablet Dy. No: 5441 International  Commitment as per (Pvt.) Ltd. Plot. Each film coated tablet contains: dated. availability not 251st meeting of RB. No.16, Zain park, Gemifloxacin 16-05-2011 provided.  Last inspection Sagian by pass mesylate…….320mg Rs.8000/- report. road Lahore. (Anti-Infectives, Quinolones) 31-07-2013 Rs.12,000/- As per SRO 5’s, 7’s 233 M/s Hygeia Hyclin Gel Form-5 Benzaclin by M/s Deferred for Pharmaceuticals, Gel Dy. No: 1106 Valeant Barmuda  Commitment as per Plot # 295, Each tube contains: dated. (USFDA) 251st meeting not Industrial Clindamycin Phosphate eq to 24-02-2015 Clinda Plus By M/s provided by the Triangle, Kahuta clindamycin……………….1% Rs.20,000/- Valor Firm. Road, Islamabad. Benzoyl Peroxide…….. 5.0% As per SRO/ Pharmaceuticals.  Readable latest (Anti bacterial, topical) 10gm inspection report. (Manufacturer Specs.)  Justification for Quantity of active in master formulation. 234 M/s Hygeia Hytrex 250mg Injection IV Form-5 Rocephin Deferred for Pharmaceuticals, Injection Dy. No: 1107 Injection 250 mg  Commitment as per Plot # 295, Each Injection contains: dated. By m/s Martin Dow 251st meeting of RB. Industrial Ceftriaxone sodium……250mg 24-02-2015 Pharmaceuticals-  Readable latest Triangle, Kahuta (Cephalosporin) Rs.20,000/- Karachi. inspection report. Road, Islamabad. (specs not provided) As per SRO/ USFDA 250mg 235 M/s Hygeia Hycute Cream Form-5 CUTA NE Cream Deferred for Pharmaceuticals, Cream Dy. No: 1108 by m/s Varioline  Commitment as per Plot # 295, Each Tube contains: dated. International (Pvt) 251st meeting of RB. Industrial Hydroquinone …… 2.0% 24-02-2015 Limited.  Readable latest Triangle, Kahuta Glycolic acid………..1.0% Rs.20,000/- Sanclear Cream By inspection report. Road, Islamabad. (Manufacturer’s Spec.) As per SRO/ m/s Sante pvt  Clarification that 30gm Limited. Demanded pack size is 30 gm while in physical parameters it is of 25gm.  Thin layer chromatography as required for testing and identification of

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hydroquinone and its cream. 236 M/s Hygeia Hyvir Cream Form-5 Clovirex Topical by Deferred for Pharmaceuticals, Cream Dy. No: 1109 M/s Brooks  Commitment as per Plot # 295, Each Tube contains: dated. Pharma. 251st meeting. Industrial Acyclovir…….5.0% 24-02-2015 Registered in  Readable latest Triangle, Kahuta Anti viral Rs.20,000/- USFDA inspection report. Road, Islamabad. Manufacturer Specs. As per SRO/  Specific tests related 10gm to acyclovir ointment. 237 M/s Medisearch Medival Syrup 250mg /5ml Form-5 Deferred for Pharmacal (Pvt.) Syrup Dy. No: 4628  Last inspection Ltd. 5KM Each 5ml contains: dated. report. Raiwind Manga Sodium Valproate eq. to Valproic 20-04-2011  Commitment as per Road Lahore. Acid………250mg Rs.8,000/- 251st meeting of RB. (Anticonvulsant) dated.31-07- In house 2013 Rs.12,000/- As per SRO 238 M/s Medisearch Cetrimed Syrup 5mg/5ml Form-5 Zyrtec By Deferred for Pharmacal (Pvt.) Syrup Dy. No: 5841 GSK  Last inspection Ltd. 5KM Each 5ml contains: dated. Gixer By Barrett report. Raiwind Manga Cetirizine 21-05-2011 Hodgson Pakistan  Commitment as per Road Lahore. Dihydrochloride……..5mg Rs.8,000/- 251st meeting of RB (Histamine H1-receptor dated.31-07- antagonist) 2013 In house Rs.12,000/- Rs.60/- / 60ml 239 M/s Zinta Protec Suspension Form-5 Given me too not Rejected for Pharmaceutical Suspension Dy. No: 59 correct.  Metronidazole 40mg Industry 168- Each 5ml contains: dated. International per 5ml is Industrial Estate Metronidazole Benzoate eq. to 27-08-2010 availability not underdose. Hayatabad, Metronidazole…..40mg (B.P) Rs.8,000/- confirmed.  Commitment as per Peshwar. Furazolidone……..25mg dated. 251st meeting of RB. (Amoebicide) 09-05-2013  It is not me too Rs.12,000/- product. As per SRO/  Latest Inspection 60ml bottle report. 240 M/s Zinta Ziprazole Capsule Form-5 Zoton by m/s weyth Deferred for Pharmaceutical Capsule Dy. No: 56 (Pfizer)  Differential fee Industry 168- Each Capsule contains: dated. Available in MHRA (12000 rupees). Industrial Estate Lansoprazole………30mg USP 27-08-2010 as gastro-resistant.  Commitment as per Hayatabad, (Proton pump inhibitor) Rs.8,000/- Fee 251st meeting of RB. Peshwar. USP Specs. Challan  Fill weight 400mg/ Rs.12000/- is capsule clarification. missed.  Correct Method of As per SRO/ testing. 1x10’s  Details of water 2x7’s processing and environment control facility.

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 Last inspection report.  Copy of official monograph for testing.  As per inspection report firm has not purchased the suggested QC equipment. 241 M/s Zinta Polyron Tablets Form-5 Apofer-F by M/s Deferred for Pharmaceutical Tablets Dy. No: 58 Platinum.  Commitment as per Industry 168- Each Tablet contains: dated. International 251st meeting of RB. Industrial Estate Iron (III) Hydroxide Polymaltose 27-08-2010 availability not  Last inspection Hayatabad, complex eq.to elemental iron Rs.8,000/- provided. report. Peshwar. ………..100mg dated.  Clarification of Iron Folic 09-05-2013 polymaltose raw Acid……………….0.35mgBP Rs.12,000/- material as it was (Haematinic) As per SRO/ Zinta specs. 1x10’s  Detailed method of manufacturing.  Details of Method for identification of raw material, sulphated ash, microbial testing.  Testing method along with validation.  Details of water processing and environment control facility.  Calculation on the basis of salt and base. 242 M/s Zinta Polyron Syrup Form-5 Ferosoft by m/s Deferred for Pharmaceutical Syrup Dy. No: 60 Hilton.  Commitment as per Industry 168- Each 5ml contains: dated. 251st meeting of RB. Industrial Estate Iron (III) Hydroxide Polymaltose 27-08-2010  Last inspection Hayatabad, complex eq.to elemental iron Rs.8,000/- report. Peshwar. ………..50mg dated.  Clarification of Iron (Iron Supplement) 09-05-2013 polymaltose raw Rs.12,000/- material as it was As per SRO/ Zinta specs. 60ml, 120ml  Detailed method of manufacturing.  Details of Method for identification of raw material, sulphated ash,

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microbial testing.  Testing method along with validation.  Details of water processing and environment control facility.  Calculation on the basis of salt and base. 243 M/s Zinta Cafidol Tablets Form-5 Fenmol Plus by m/s Deferred for Pharmaceutical Tablets Dy. No: 55 polyfine.  Commitment as per Industry 168- Each Tablet contains: dated. International 251st meeting. Industrial Estate Caffiene………..65mgBP 27-08-2010 availability not  Latest Inspection Hayatabad, Paracetamol …….500mgBP Rs.8,000/- provided. report. Peshwar. Chlorphenramin dated.  Method for Maleate…….2mgBP 09-05-2013 identification of raw (Analgesic) Rs.12,000/- material (API). As per SRO/  Testing method 20x10’s along with validation.  Details of water processing and environment control facility.  Calculation on the basis of salt and base.  Complete master formulation. 244 M/s PDH Omecer Capsule Form-5 Meprazole Capsule Deferred for Pharmaceuticals, Capsules Dy. No: 964 40mg By M/s  Commitment as per (pvt) ltd. 19 km Each capsule contains: dated. Werrick 251st meeting of RB. Ferozpur Road, Omeprazole…..40mg 08-12-2011 Pharmaceuticals  Latest Inspection Lahore. (Proton Pump Inhibitor) Rs.8,000/- report. USP Specs. dated.  Clarification for 08-09-2011 using lactose in Rs.12,000/- formulation. dated.  Pallet source and 06-05-2013 relavent documents. As per SRO/ 1x5’s 245 M/s Macter Ciclenoide Form-5-D Alvesco by M/s Deferred for International, F- Inhaler Dy. No: 271 Takeda GMBH  Commitment as per 216 S.I.T.E. Each actuation contains: dated. (USFDA) 251st meeting of RB. Karachi. ciclesonide…..160mcg 30-11-2010  Latest Inspection (corticosteroid) Rs.15,000/- report. Specs not mentioned. dated.  Differential fee. 30-11-2010  Stability Data as per As per PRC/ guidelines approved

Minutes for 254th Registration Board Meeting 331

by the board in 249th meeting. 246 M/s Macter Ciclenoide Form-5-D Alvesco by M/s Deferred for International, F- Inhaler Dy. No: 271 Takeda GMBH  Commitment as per 216 S.I.T.E. Each actuation contains: dated. (USFDA) 251st meeting of RB. Karachi. ciclesonide…..80mcg 30-11-2010  Latest Inspection (corticosteroid) Rs.15,000/- report. Specs not mentioned. dated.  Differential fee. 30-11-2010  Stability Data as per As per PRC/ guidelines approved by the board in 249th meeting. 247 M/s Rotexmedica Deftec 50mg Form-5 Galvus by M/s Deferred for Pakistan (Pvt) Tablet Dy. No: 850 Novartis  Commitment as per Ltd, Kahuta Road Each tablet contains: dated. Registered in 251st meeting of RB. Islamabad. Vildagliptin…..50mg 31-12-2010 MHRA  Latest Inspection (Dipeptidyl Peptidase-4 inhibitor Rs.8,000/- report. Anti diabetic/ Oral dated.  Differential fee. Hypoglycemic) 11-12-2013  Stability Data as per Rotexmedica Specs. Rs:12000/- guidelines approved As per PRC/ by the board in 249th 28’s meeting. 248 M/s ALLMED K-CIT Form-5-D Alvesco by M/s Deferred for (Private) limited, Tablet Dy. No: 5139 Takeda GMBH  Commitment as per sundar industrial Each extended release Tablet dated. (USFDA) 251st meeting of RB. estate, Lahore. contains: 31-05-2012  Latest Inspection Potassium Citrate…..10mEq Rs.8,000/- report. (1080mg) dated.  Differential fee for (Alkalizing agent) 11-10-2012 Form 5-D. Manufacturer Specs Rs:12,000/  Stability Data as per As per PRC/ guidelines approved by the board in 249th meeting of RB.

Minutes for 254th Registration Board Meeting 332

Miscellaneous Cases of Pharmaceutical Evaluation Cell:

EVALUATOR IV

Case No. 01: M/S AMBROSIA PHARMACEUTICALS LOCATED AT PLOT#18, STREET # 09, NATIONAL INDUSTRIAL ZONE, RAWAT.

M/s Ambrosia Pharmaceuticals, Rawat applied for registration of following products on prescribed Form 5. S # Brand Name Generic 250. Gabalin Capsule 100mg Pregabalin 100mg 251. Gabalin Capsule 75mg Pregabalin 75mg 252. Gabalin Capsule 50mg Pregabalin 50mg

After evaluation, these products were included in agenda of 247th meeting of Registration Board and also discussed in 247th meeting of the Board wherein these products were deferred due to certain shortcomings. After submission of shortcomings by the firm, Registration Board in its 248th meeting held on 18th – 19th March 2015 again considered the above mentioned products wherein Board approved all the above mentioned products. Unfortunately, the decision was not recorded in minutes of 248th meeting for one of the above mentioned products i.e. Gabalin Capsule 50mg, which was approved by the Board during meeting but the decision column of the minutes remained blank due to typographical mistake. The firm has received letter of Registration for the other two products with the brand names Capsule Ambrogab 100mg & Capsule Ambrogab 75mg as the initial proposed name (Gabalin) resembled with the existing brand. Firm has now requested to re-consider the product for which decision was not recorded in the minutes of 248th meeting of RB due to typographical mistake so that letter of registration may be issued for the proposed product with the brand name Ambrogab 50mg Capsule.

Decesion: Registration Board approved the product Amrogab 50mg Capsule.

Minutes for 254th Registration Board Meeting 333

Case No. 02:- M/S INTERNATIONAL PHARMA LABS, RAIWIND ROAD, BHOBTIAN CHOWK, DEFENCE ROAD, LAHORE.

In 251st meeting of Registration Board following products of M/s International Pharmaceuticals, Lahore were discussed and approved. 1. INTERVIT C ORAL POWDER. 2. I-TYLODOX-C ORAL SOLUTION. The firm requested to correct the recording of the minutes of 251st meeting for their products because complete description of dosage form is missing in the recorded minutes as under:-

Item # in Item approved in 251st meetings Items name applied 251st min. 253. INTERVIT C ORAL POWDER INTERVIT C ORAL POWDER Acetyl Salicylic Acid 20gm Ascorbic Acid 20gm Each 100gm contains:- Vitamin K3 2.5gm Acetyl Salicylic Acid 20gm Ascorbic Acid 20gm Vitamin K3 2.5gm 254. I-TYLODOX-C ORAL SOLUTION I-TYLODOX-C ORAL SOLUTION Tylosin Tartrate 14gm Doxycycline HCl 16gm Each 100ml contains:- Colistin Sulphate 120miu Tylosin Tartrate 14gm Doxycycline HCl 16gm Colistin Sulphate 120miu

Decision:- Registration Board approved to re-issue registration letter as per correct description.

Minutes for 254th Registration Board Meeting 334

Case No.03: Replacement of rejected Case Evaluator II

M/s GMP Meclomide Form-5 Maxlon by M/s Approved Pharmaceuticals, Injection (IV) Dy. No: 995 Amdipharm PLC 28KM Each 2ml contains: dated. UK (MHRA, US- Sheikhupura metroclopramide…10mg/2ml 02-10-15 FDA) Road Lahore. Anti-emetic Rs.20000/- Clopan by M/s Siza USP-32 Specs (As per SRO) 10 x 2ml Evaluator I

M/s Herbion MonteNovex 10mg Tablet Form-5 BNF 10mg film Approved Pakistan (Pvt) Each film coated tablet 11-03-2015 coated tablet Ltd, Industrial contains Montelukast diary No Triangle Kahuta Sodium eq to Montelukast 1568. Aerokast 10mg Road, 10mg Rs20,000 by M/s Barrett Islamabad. Leukotriene Receptor As per SRO/ Hodgson Antagonist Blister of Manufacturer’s 14’s Pack Specifications

Minutes for 254th Registration Board Meeting 335

Case No.04: Submission of Stability Data:

Registration Board discussed and evaluated the stability data submitted by the applicants in the light of recommendations of the board finalized in 251st meeting. Registration Board also decided to to investigate the authenticity/genuineness of data (import of raw material and stability data submitted for registration) of New Chemical Entities / New Drugs, in light of directions of Ministry of National Health Services, Regulation & Coordination vide letter No. F. 3-71/2015-DRAP/NHSR&C dated 06.11.2015.

1. M/s Hilton Pharma, Karachi

Drug Sofohil tablets (Sofosbuvir) 400 mg Source Virupaksha Organics Limited, India Storage Condition Real Time: 30°C and 65% RH Accelerated: 40°C and 75% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 3, 5.5 , 6 months Batch Size 400 Tablets, 400 Tablets, 400 Tablets No. of Batches 03 Sample Size 25 tablets Meeting Deferred in 244th & 253rd meeting of Registration Board for stability as per WHO/ICH guidelines

Minutes for 254th Registration Board Meeting 336

M/s Hilton Pharma, Karachi Attributes Tested (Batch 1) On Going Long Term

Batch Number : Date of Manufacturing: Proposed Expiry Date: Potency : SOF-194612-3 17-04-2015 2 Years 400mg / Tablet Kept on stability : Container : Storage Temperature : Storage Humidity : 20-04-2015 Alu Alu Foil Blister 30°C ± 2°C 65% ± 5%

RESULTS AT TEST STATIONS Tested / Analyzed For Specification Limits Dates Apr-15 Jul-15 Sep-15 Oct-15 Months Initial 3rd Approx 5 and half month 6th

White, Oblong, film White, Oblong, film White, Oblong, film coated White, Oblong, film White, Oblong, film coated Description coated tablets coated tablets tablets coated tablets tablets

Assay 90 -- 110 % 100.62% 100.40% 99.76% 99.55% NLT 85% (Q+5%) Dissolution 100% 99% 98% 97% in 20 minutes Degradation products NMT 0.5% Not detected Not detected GS-606965 Not detected Not detected NMT 0.5% Not detected Not detected GS-331007 Not detected Not detected NMT 0.5% Not detected Not detected GS-566500 Not detected Not detected NMT 0.5% Not detected Not detected GS-607669 Not detected Not detected NMT 0.5% Not detected Not detected GS-607670 Not detected Not detected NMT 0.5% Not detected Not detected Phenol Not detected Not detected

Unspecified NMT 0.2% Not detected Not detected Not detected Not detected Degradation Product

Total degradation NMT 0.8% Not detected Not detected Not detected Not detected product

Minutes for 254th Registration Board Meeting 337

M/s Hilton Pharma, Karachi Attributes Tested (Batch 1) Short Time

Batch Number : Date of Manufacturing: Proposed Expiry Date: Potency : SOF-194612-3 17-04-2015 2 Years 400mg / Tablet Kept on stability : Container : Storage Temperature : Storage Humidity : 20-04-2015 Alu Alu Foil Blister 40°C ± 2°C 75% ± 5%

RESULTS AT TEST STATIONS Tested / Analyzed For Specification Limits Dates Apr-15 Jul-15 Sep-15 Oct-15 Months Initial 3rd Approx 5 and half month 6th

White, Oblong, film White, Oblong, film White, Oblong, film coated White, Oblong, film White, Oblong, film coated Description coated tablets coated tablets tablets coated tablets tablets

Assay 90 -- 110 % 100.62% 99.70% 99.43% 99.29% NLT 85% (Q+5%) Dissolution 100% 99% 97% 97% in 20 minutes Degradation products NMT 0.5% Not detected Not detected GS-606965 Not detected Not detected NMT 0.5% Not detected Not detected GS-331007 Not detected Not detected NMT 0.5% Not detected Not detected GS-566500 Not detected Not detected NMT 0.5% Not detected Not detected GS-607669 Not detected Not detected NMT 0.5% Not detected Not detected GS-607670 Not detected Not detected NMT 0.5% Not detected Not detected Phenol Not detected Not detected

Unspecified NMT 0.2% Not detected Not detected Not detected Not detected Degradation Product

Total degradation NMT 0.8% Not detected Not detected Not detected Not detected product

Minutes for 254th Registration Board Meeting 338

M/s Hilton Pharma, Karachi Attributes Tested (Batch 2) On Going Long Term

Batch Number : Date of Manufacturing: Proposed Expiry Date: Potency : SOF-197604-4 18-04-2015 2 Years 400mg / Tablet Kept on stability : Container : Storage Temperature : Storage Humidity : 20-04-2015 Alu Alu Foil Blister 30°C ± 2°C 65% ± 5%

RESULTS AT TEST STATIONS Tested / Analyzed For Specification Limits Dates Apr-15 Jul-15 Sep-15 Oct-15 Months Initial 3rd Approx 5 and half month 6th

White, Oblong, film White, Oblong, film White, Oblong, film coated White, Oblong, film White, Oblong, film coated Description coated tablets coated tablets tablets coated tablets tablets

Assay 90 -- 110 % 100.04% 99.91% 99.49% 99.28% NLT 85% (Q+5%) Dissolution 95% 95% 94% 94% in 20 minutes Degradation products NMT 0.5% Not detected Not detected GS-606965 Not detected Not detected NMT 0.5% Not detected Not detected GS-331007 Not detected Not detected NMT 0.5% Not detected Not detected GS-566500 Not detected Not detected NMT 0.5% Not detected Not detected GS-607669 Not detected Not detected NMT 0.5% Not detected Not detected GS-607670 Not detected Not detected NMT 0.5% Not detected Not detected Phenol Not detected Not detected

Unspecified NMT 0.2% Not detected Not detected Not detected Not detected Degradation Product

Total degradation NMT 0.8% Not detected Not detected Not detected Not detected product

Minutes for 254th Registration Board Meeting 339

M/s Hilton Pharma, Karachi Attributes Tested (Batch 2) Short Term

Batch Number : Date of Manufacturing: Proposed Expiry Date: Potency : SOF-194604-4 18-04-2015 2 Years 400mg / Tablet Kept on stability : Container : Storage Temperature : Storage Humidity : 20-04-2015 Alu Alu Foil Blister 40°C ± 2°C 75% ± 5%

RESULTS AT TEST STATIONS Tested / Analyzed For Specification Limits Dates Apr-15 Jul-15 Sep-15 Oct-15 Months Initial 3rd Approx 5 and half month 6th

White, Oblong, film White, Oblong, film White, Oblong, film coated White, Oblong, film coated White, Oblong, film coated Description coated tablets coated tablets tablets tablets tablets

Assay 90 -- 110 % 100.04% 99.53% 99.14% 99.00% NLT 85% (Q+5%) in Dissolution 95% 94% 93% 93% 20 minutes Degradation products NMT 0.5% Not detected Not detected GS-606965 Not detected Not detected NMT 0.5% Not detected Not detected GS-331007 Not detected Not detected NMT 0.5% Not detected Not detected 566500 Not detected Not detected NMT 0.5% Not detected Not detected GS-607669 Not detected Not detected NMT 0.5% Not detected Not detected GS-607670 Not detected Not detected NMT 0.5% Not detected Not detected Phenol Not detected Not detected

Unspecified NMT 0.2% Not detected Not detected Not detected Not detected Degradation Product

Total degradation NMT 0.8% Not detected Not detected Not detected Not detected product

Minutes for 254th Registration Board Meeting 340

M/s Hilton Pharma, Karachi Attributes Tested (Batch 3) On Going Term

Batch Number : Date of Manufacturing: Proposed Expiry Date: Potency : SOF-197704-5 18-04-2015 2 Years 400mg / Tablet Kept on stability : Container : Storage Temperature : Storage Humidity : 20-04-2015 Alu Alu Foil Blister 30°C ± 2°C 65% ± 5%

RESULTS AT TEST STATIONS Tested / Analyzed For Specification Limits Dates Apr-15 Jul-15 Sep-15 Oct-15 Months Initial 3rd Approx 5 and half month 6th

White, Oblong, film White, Oblong, film White, Oblong, film coated White, Oblong, film White, Oblong, film coated Description coated tablets coated tablets tablets coated tablets tablets

Assay 90 -- 110 % 100.38% 99.89% 99.58% 99.53% NLT 85% (Q+5%) Dissolution 98% 98% 97% 97% in 20 minutes Degradation products NMT 0.5% Not detected Not detected GS-606965 Not detected Not detected NMT 0.5% Not detected Not detected GS-331007 Not detected Not detected NMT 0.5% Not detected Not detected GS-566500 Not detected Not detected NMT 0.5% Not detected Not detected GS-607669 Not detected Not detected NMT 0.5% Not detected Not detected GS-607670 Not detected Not detected NMT 0.5% Not detected Not detected Phenol Not detected Not detected

Unspecified NMT 0.2% Not detected Not detected Not detected Not detected Degradation Product

Total degradation NMT 0.8% Not detected Not detected Not detected Not detected product

Minutes for 254th Registration Board Meeting 341

M/s Hilton Pharma, Karachi Attributes Tested (Batch 3) Short Term

Batch Number : Date of Manufacturing: Proposed Expiry Date: Potency : SOF-197704-5 18-04-2015 2 Years 400mg / Tablet Kept on stability : Container : Storage Temperature : Storage Humidity : 20-04-2015 Alu Alu Foil Blister 40°C ± 2°C 75% ± 5%

RESULTS AT TEST STATIONS Tested / Analyzed For Specification Limits Dates Apr-15 Jul-15 Sep-15 Oct-15 Months Initial 3rd Approx 5 and half month 6th

White, Oblong, film White, Oblong, film White, Oblong, film coated White, Oblong, film coated White, Oblong, film coated Description coated tablets coated tablets tablets tablets tablets

Assay 90 -- 110 % 100.38% 99.51% 99.18% 98.99% NLT 85% (Q+5%) in Dissolution 98% 97% 96% 96% 20 minutes Degradation products NMT 0.5% Not detected Not detected GS-606965 Not detected Not detected NMT 0.5% Not detected Not detected GS-331007 Not detected Not detected NMT 0.5% Not detected Not detected GS-566500 Not detected Not detected NMT 0.5% Not detected Not detected GS-607669 Not detected Not detected NMT 0.5% Not detected Not detected GS-607670 Not detected Not detected NMT 0.5% Not detected Not detected Phenol Not detected Not detected

Unspecified NMT 0.2% Not detected Not detected Not detected Not detected Degradation Product

Total degradation NMT 0.8% Not detected Not detected Not detected Not detected product

Minutes for 254th Registration Board Meeting 342

Documents / Data provided by the applicants (M/s Hilton Pharma, Karachi) 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 Yes by regulatory authority of country of origin. 3. Protocol followed for conduction of stability study and details of tests. Yes 4. Data of 3 batches will be supported by attested respective documents like chromatograms, laboratory reports, Yes data sheets etc. 5. Documents confirming import of API etc. Yes (ADC cleared) 6. All provided documents will be attested (name, sign and stamp) for ensuring Yes Authenticity of data / documents. 7. Commitment to continue real time stability study till assigned Yes

Decision: Registration Board observed that the stability data provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. Further, the panel comprising of Brig. Muzamil H. Najmi Member Registration Board, Dr. Obaidullah, DDG R I and Dr. Saifur Rehman Khattak, Federal Government Analyst, CDL, Karachi shall also inspect the premesis to ensure authenticity of data.

Minutes for 254th Registration Board Meeting 343

2. M/s Genome Pharma Hattar

Stability Study Data Sheet

1.0 Product details: Product name /Generic CINAROID-30MG (CINACALCET HCL) TABLETS Batch No. T-001 name/Dosage form Description of pack 10 Tablets in Alu Alu Blister Packed in Card Board Unit Batch Size. 1000 Tablets (container closure system) Carton. Parameters and tests mentioned As per Product Specifications (Genome Spec’s) Mfg. Date 18-03-2015 Recommended storage Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 17-03-2017 conditions

Date of initiation & 19-03-2015 (API) lot no. CINACALCET HCL implementation Batch No. CI141201 Chongquing Fuan Stability No. ST/GP/CIN30-001 Source Group, China.

Sample taken for physical tests = 24 Tabs Approval by: Sample taken for Chemical tests = 104 Tabs

Sample taken for Microbiological tests = N/A QC Manager:------Extra samples (if needed) = N/A

Total Sample size (approx) = 128 Tabs QA Manager:------

Production Manager:------

Minutes for 254th Registration Board Meeting 344

R&D Manager:------

Stability Study Data Sheet

1.0 Product details: Product name /Generic CINAROID-30MG (CINACALCET HCL) TABLETS Batch No. T-002 name/Dosage form Description of pack 10 Tablets in Alu Alu Blister Packed in Card Board Unit Batch Size. 1000 Tablets (container closure system) Carton. Parameters and tests mentioned As per Product Specifications (Genome Spec’s) Mfg. Date 20-03-2015 Recommended storage Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 19-03-2017 conditions

Date of initiation & 21-03-2015 (API) lot no. CINACALCET HCL implementation Batch No. CI141201 Chongquing Fuan Stability No. ST/GP/CIN30-002 Source Group, China.

Approval by:

QC Manager:------Sample taken for physical tests = 24 Tabs Sample taken for Chemical tests = 104 Tabs QA Manager:------Sample taken for Microbiological tests = N/A Extra samples (if needed) = N/A Total Sample size (approx) = 128 Tabs Minutes for 254th Registration Board Meeting 345

Production Manager:------

R&D Manager:------

Stability Study Data Sheet

1.0 Product details: Product name /Generic CINAROID-30MG (CINACALCET HCL) TABLETS Batch No. T-003 name/Dosage form Description of pack 10 Tablets in Alu Alu Blister Packed in Card Board Unit Batch Size. 1000 Tablets (container closure system) Carton. Parameters and tests mentioned As per Product Specifications (Genome Spec’s) Mfg. Date 23-03-2015 Recommended storage Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 22-03-2017 conditions

Date of initiation & 24-03-2015 (API) lot no. CINACALCET HCL implementation Batch No. CI141201 Chongquing Fuan Stability No. ST/GP/CIN30-003 Source Group, China.

Approval by:

QC Manager:------Sample taken for physical tests = 24 Tabs Sample taken for Chemical tests = 104 Tabs QA Manager:------Sample taken for Microbiological tests = N/A Extra samples (if needed) = N/A Minutes for 254th Registration Board Meeting 346 Total Sample size (approx) = 128 Tabs

Production Manager:------

R&D Manager:------

Stability Study Data Sheet

1.0 Product details: Product name /Generic CINAROID-30MG (CINACALCET HCL) TABLETS Batch No. T-001 name/Dosage form Description of pack 10 Tablets in Alu Alu Blister Packed in Card Board Unit Batch Size. 1000 Tablets (container closure system) Carton. Parameters and tests mentioned As per Product Specifications (Genome Spec’s) Mfg. Date 18-03-2015 Recommended storage Long Term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 17-03-2017 conditions

Date of initiation & 19-03-2015 (API) lot no. CINACALCET HCL implementation Batch No. CI141201 Chongquing Fuan Stability No. ST/GP/CIN30-001 Source Group, China.

Approval by:

QC Manager:------Sample taken for physical tests = 24 Tabs Sample taken for Chemical tests = 104 Tabs Sample taken for Microbiological tests = N/A Minutes for 254th Registration Board Meeting 347 Extra samples (if needed) = N/A Total Sample size (approx) = 128 Tabs

QA Manager:------

Production Manager:------

R&D Manager:------

Stability Study Data Sheet

1.0 Product details: Product name /Generic CINAROID-30MG (CINACALCET HCL) TABLETS Batch No. T-002 name/Dosage form Description of pack 10 Tablets in Alu Alu Blister Packed in Card Board Unit Batch Size. 1000 Tablets (container closure system) Carton. Parameters and tests mentioned As per Product Specifications (Genome Spec’s) Mfg. Date 20-03-2015 Recommended storage Long Term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 19-03-2017 conditions

Date of initiation & 21-03-2015 (API) lot no. CINACALCET HCL implementation Batch No. CI141201 Chongquing Fuan Stability No. ST/GP/CIN30-002 Source Group, China.

Approval by:

QC Manager:------Sample taken for physical tests = 24 Tabs Sample taken for Chemical tests = 104 Tabs Minutes for 254th Registration Board Meeting 348 Sample taken for Microbiological tests = N/A Extra samples (if needed) = N/A Total Sample size (approx) = 128 Tabs

QA Manager:------

Production Manager:------

R&D Manager:------

Stability Study Data Sheet 1.0 Product details: Product name /Generic CINAROID-30MG (CINACALCET HCL) TABLETS Batch No. T-003 name/Dosage form Description of pack 10 Tablets in Alu Alu Blister Packed in Card Board Unit Batch Size. 1000 Tablets (container closure system) Carton. Parameters and tests mentioned As per Product Specifications (Genome Spec’s) Mfg. Date 23-03-2015 Recommended storage Long Term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 22-03-2017 conditions

Date of initiation & 24-03-2015 (API) lot no. CINACALCET HCL implementation Batch No. CI141201 Chongquing Fuan Stability No. ST/GP/CIN30-003 Source Group, China.

Approval by:

QC Manager:------Sample taken for physical tests = 24 Tabs Sample taken for Chemical tests = 104 Tabs Minutes for 254th Registration Board Meeting 349 Sample taken for Microbiological tests = N/A Extra samples (if needed) = N/A Total Sample size (approx) = 128 Tabs

QA Manager:------

Production Manager:------

R&D Manager:------

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 30mg/Tablet claimed Batch No. T-001 Location of studies Quality Control Lab Mfg. Date 18-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack 40ºC ± 2 ºC / 75 % ± 5% RH Expiry date 17-03-2017 Storage Conditions

Results: Frequency/Date Tests Specifications 0 Months 1 Months 2 Months 3 Months 6 Months 19-03-2015 19-04-2015 19-05-2015 19-06-2015 19-09-2015 White to off white, Description round,unscored,biconvex Off-white Off-white Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies Complies Complies positive D.T NMT 30 minutes 02 minutes 02 minutes 02 minutes 03 minutes 04 minutes

Minutes for 254th Registration Board Meeting 350

NLT 75%(Q) in 45 Dissolution 92.86% 92.16% 92.42% 91.37% 91.10% minutes Assay 90%-110% of label claim 100.35% 100.28% 100.12.% 99.98% 99.80%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 30mg/Tablet claimed Batch No. T-002 Location of studies Quality Control Lab Mfg. Date 20-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack 40ºC ± 2 ºC / 75 % ± 5% RH Expiry date 19-03-2017 Storage Conditions

Results: Frequency/Date Tests Specifications 0 Months 1 Months 2 Months 3 Months 6 Months 21-03-2015 21-04-2015 21-05-2015 21-06-2015 21-09-2015 White to off white, Description round,unscored,biconvex Off-white Off-white Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies Complies Complies positive Minutes for 254th Registration Board Meeting 351

D.T NMT 30 minutes 02 minutes 02 minutes 02 minutes 03 minutes 04 minutes NLT 75%(Q) in 45 Dissolution 93.12% 93.06% 92.42% 92.23% 91.52% minutes Assay 90%-110% of label claim 101.25% 100.98% 100.61.% 100.28% 100.15%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 30mg/Tablet claimed Batch No. T-003 Location of studies Quality Control Lab Mfg. Date 23-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack 40ºC ± 2 ºC / 75 % ± 5% RH Expiry date 22-03-2017 Storage Conditions

Results: Frequency/Date Tests Specifications 0 Months 1 Months 2 Months 3 Months 6 Months 24-03-2015 24-04-2015 24-05-2015 24-06-2015 21-09-2015 White to off white, Description round,unscored,biconvex Off-white Off-white Off-white Off-white Off-white film coated tablet

Minutes for 254th Registration Board Meeting 352

Cinacalcet HCl should be Identification Complies Complies Complies Complies Complies positive D.T NMT 30 minutes 02 minutes 02 minutes 02 minutes 03 minutes 04 minutes NLT 75%(Q) in 45 Dissolution 94.1% 93.7% 93.5% 93.2% 92.55% minutes Assay 90%-110% of label claim 100.52% 100.42% 100.25% 100.19% 100.05%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 30mg/Tablet claimed Batch No. T-001 Location of studies Quality Control Lab Mfg. Date 18-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Expiry date 17-03-2017 Storage Conditions 30ºC ± 2 ºC / 65 % ± 5% RH

Results: Frequency/Date Tests Specifications 0 Month 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months 19-03-2015 19-06-2015 19-09-2015 19-12-2015 19-03-2016 19-09-2016 19-03-2017 White to off white, Description round,scored,biconvex Off-white Off-white Off-white film coated tablet

Minutes for 254th Registration Board Meeting 353

Cinacalcet HCl should be Identification Complies Complies Complies positive D.T NMT 30 minutes 2 minutes 06minutes 06minutes NLT 75%(Q) in 45 Dissolution 94.56% 92.89 % minutes 92.86% Assay 90%-110% of label claim 100.35% 100.36% 100.14% Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 30mg/Tablet claimed Batch No. T-002 Location of studies Quality Control Lab Mfg. Date 20-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Expiry date 19-03-2017 Storage Conditions 30ºC ± 2 ºC / 65 % ± 5% RH

Results: Frequency/Date Tests Specifications 0 Months 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months 21-03-2015 21-06-2015 21-09-2015 21-12-2015 21-03-2016 21-09-2016 21-03-2017 White to off white, Description Off-white Off-white Off-white round,scored,biconvex Minutes for 254th Registration Board Meeting 354

film coated tablet

Cinacalcet HCl should be Identification Complies Complies Complies positive D.T NMT 30 minutes 02 minutes 06minutes 06minutes NLT 75%(Q) in 45 Dissolution 93.12% 92.65% 91.33% minutes Assay 90%-110% of label claim 101.25% 102.55% 101.45%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 60mg Tablets Potency/ label Cinacalcet as HCl 60mg/Tablet claimed Batch No. T-001 Location of Studies Quality Control Lab Mfg. Date 18-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Expiry date 17-03-2017 Storage Conditions 40ºC ± 2 ºC / 75 % ± 5% RH

Results: Frequency/Date Tests Specifications 0 Months 1 Months 2 Months 3 Months 6 Months 19-03-2015 19-04-2015 19-05-2015 19-06-2015 19-09-2015 Minutes for 254th Registration Board Meeting 355

White to off white, Description round,scored,biconvex Off-white Off-white Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies Complies Complies positive D.T NMT 30 minutes 03 minutes 03 minutes 03 minutes 04 minutes 05 minutes NLT 75%(Q) in 45 Dissolution 93.68% 93.25% 93.15% 92.68% 92.25% minutes Assay 90%-110% of label claim 100.65% 100.55% 100.46.% 100.35% 100.18%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 60mg Tablets Potency/ label Cinacalcet as HCl 60mg/Tablet claimed Batch No. T-002 Location of Studies Quality Control Lab Mfg. Date 20-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Expiry date 19-03-2017 Storage Conditions 40ºC ± 2 ºC / 75 % ± 5% RH

Results: Frequency/Date Tests Specifications 0 Months 1 Months 2 Months 3 Months 6 Months 21-03-2015 21-04-2015 21-05-2015 21-06-2015 21-09-2015

Minutes for 254th Registration Board Meeting 356

White to off white, Description round,scored,biconvex Off-white Off-white Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies Complies Complies positive D.T NMT 30 minutes 03 minutes 04 minutes 04minutes 05 minutes 05 minutes NLT 75%(Q) in 45 Dissolution 92.42% 92.14% 92.04% 91.87% 91.47% minutes Assay 90%-110% of label claim 100.89% 100.65% 100.48% 100.35% 100.21%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 60mg Tablets Potency/ label Cinacalcet as HCl 60mg/Tablet claimed Batch No. T-003 Location of Studies Quality Control Lab Mfg. Date 23-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Expiry date 22-03-2017 Storage Conditions 40ºC ± 2 ºC / 75 % ± 5% RH

Results: Frequency/Date Tests Specifications 0 Months 1 Months 2 Months 3 Months 6 Months 24-03-2015 24-04-2015 24-05-2015 24-06-2015 21-09-2015

Minutes for 254th Registration Board Meeting 357

White to off white, Description round,scored,biconvex Off-white Off-white Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies Complies Complies positive D.T NMT 30 minutes 03 minutes 03 minutes 03minutes 04 minutes 05 minutes NLT 75%(Q) in 45 Dissolution 93.25% 93.10% 92.96% 92.80% 91.95% minutes Assay 90%-110% of label claim 100.69% 100.52% 100.35% 100.23% 100.10%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 30mg/Tablet claimed Batch No. T-003 Location of studies Quality Control Lab Mfg. Date 23-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Expiry date 22-03-2017 Storage Conditions 30ºC ± 2 ºC / 65 % ± 5% RH

Results: Frequency/Date Tests Specifications 0 Months 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months

Minutes for 254th Registration Board Meeting 358

24-03- 24-06-2015 21-09-2015 24-12-2015 24-03-2016 24-09-2016 24-03-2017 2015 White to off white, Description round,scored,biconvex Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies positive D.T NMT 30 minutes 02 minutes 06minutes 06minutes NLT 75%(Q) in 45 Dissolution 94.1% 93.16% 92.64% minutes Assay 90%-110% of label claim 100.52% 99.65 % 99.84 %

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 60mg Tablets Potency/ label Cinacalcet as HCl 60mg/Tablet claimed Batch No. T-001 Location of Studies Quality Control Lab Mfg. Date 18-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack 30ºC ± 2 ºC / 65 % ± 5% RH Expiry date 17-03-2017 Storage Conditions

Tests Specifications Results: Frequency/Date

Minutes for 254th Registration Board Meeting 359

0 Months 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months 19-03- 19-06-2015 19-09-2015 19-12-2015 19-03-2016 19-09-2016 19-03-2017 2015 White to off white, Description round,scored,biconvex Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies positive D.T NMT 30 minutes 03 minutes 06minutes 06minutes NLT 75%(Q) in 45 Dissolution 93.68% 94.56% 92.89% minutes Assay 90%-110% of label claim 100.65% 100.36% 100.14%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 30mg Tablets Potency/ label Cinacalcet as HCl 60mg/Tablet claimed Batch No. T-002 Location of Studies Quality Control Lab Mfg. Date 20-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack 40ºC ± 2 ºC / 75 % ± 5% RH Expiry date 19-03-2017 Storage Conditions Minutes for 254th Registration Board Meeting 360

Results: Frequency/Date Tests Specifications 0 Months 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months 21-03-2015 21-06-2015 21-09-2015 21-12-2015 21-03-2016 21-09-2016 21-03-2017 White to off white, Description round,scored,biconvex Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies positive D.T NMT 30 minutes 03 minutes 06minutes 06minutes NLT 75%(Q) in 45 Dissolution 92.42% 91.68% 92.33% minutes Assay 90%-110% of label claim 100.89% 100.55% 100.41%

Tested by QC Analyst

Checked by QC Manager

Name Of Product Cinaroid 60mg Tablets Potency/ label Cinacalcet as HCl 60mg/Tablet claimed Batch No. T-003 Location of Studies Quality Control Lab Mfg. Date 23-03-2015 Storage Container 10 Tablets in Alu-Alu Blister/Pack Minutes for 254th Registration Board Meeting 361

30ºC ± 2 ºC / 65 % ± 5% RH Expiry date 22-03-2017 Storage Conditions

Results: Frequency/Date

Tests Specifications 0 Months 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months 24-03- 24-06-2015 21-09-2015 24-12-2015 24-03-2016 24-09-2016 24-03-2017 2015 White to off white, Description round,scored,biconvex Off-white Off-white Off-white film coated tablet Cinacalcet HCl should be Identification Complies Complies Complies positive D.T NMT 30 minutes 03 minutes 06 minutes 06 minutes NLT 75%(Q) in 45 Dissolution 93.25% 92.16% 91.64% minutes Assay 90%-110% of label claim 100.69% 100.65% 100.21 %

Tested by QC Analyst

Checked by QC Manager

Decision: Registration Board observed that the stability data provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Cinacalcet as HCl 60mg to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. Further, the panel comprising of Brig. Muzamil H. Najmi Member Registration Board, Dr. Obaidullah, DDG R I and Dr. Saifur Rehman Khattak, Federal Government Analyst, CDL, Karachi shall also inspect the premesis to ensure authenticity of data. Minutes for 254th Registration Board Meeting 362

3. PharmEvo, Pvt. Ltd. Karachi

Drug Zoval Tablets (Sofosbuvir) 400 mg Sources Zhejiang Jiangbei Pharmaceutical Co, Ltd. Ruyuan HEC Pharm, Co., Ltd. Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 75% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 1,2, 3, 6 months Batch Size Batch 1: 400 tab (completed with 6 months ACC & 9 month RT) Batch 2: 250 tab (Completed) Batch 3: 300 tab (Completed) Batch 4: 300 tab (Completed) Batch 5: 24500 tab (3months stability completed) No. of Batches 05 Sample Size 20 tablets

Meeting Deferred in 244th and 251st meeting of Registration Board for stability as per WHO/ICH guidelines

Product name /Generic name /Dosage form Zoval 400mg tablets Batch No. 14SBV-1340-02-T

Minutes for 254th Registration Board Meeting 363

Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 400 Tablets (container closure packed in Alu Alu foil in a printed unit carton system) Parameters and As per Product Specifications (PharmEvo Specs) Mfg. Date Oct 2014 tests mentioned  Short term conditions (Accelerated) 40±2C,75±5 RH Recommended  Long term conditions 30±2C,75±5 RH Exp Date Oct 2016 storage condition

Date of initiation Oct-2014 (API) lot no. CTG02-140827002 & Stability No. CN# 613

Approved by: Total Sample size (approx.) = 20 QC Manager: ------QA Manager: ------Production Manager: ------R&D

Manager: ------

Minutes for 254th Registration Board Meeting 364

Assessment frequency (Months) Initial 3 6 Date of Testing 06-11-2014 10-02-2015 12-05-2015 Mode of testing (F=full.) FF F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Accelerated) Appearance Yellow color oblong biconvex 40◦C ± 2◦C & 75% Complies Complies Complies shape film coated tablet plain from RH. ± 5% RH. both sides

Identification Positive for Sofosbuvir by HPLC. 40◦C ± 2◦C & 75% Retention Retention Retention The retention time of the Sample RH. ± 5% RH. peak in the chromatogram of the time time time assay preparation corresponds to complies complies complies that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 915.4 mg 915.8 mg 915.1 mg WEIGHT/TAB RH. ± 5% RH.

◦ ◦ LENGTH 18.80 – 19.20 mm 40 C ± 2 C & 75% 19.04 mm 19.07mm 19.02 mm RH. ± 5% RH. 8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.01 mm 9.05 mm 9.03 mm WIDTH RH. ± 5% RH. 6.30 – 6.90 mm 40◦C ± 2◦C & 75% 6.60 mm 6.68mm 6.65 mm THICKNESS RH. ± 5% RH NMT 30 mins. 40◦C ± 2◦C & 75% 4 mins. 6 mins 3 mins DISINTEGRATION RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% (SOFOSUBVIR ) Not less than 80% after 45 minutes RH. ± 5% RH 98.39% 93.45% 90.07% 40◦C ± 2◦C & 75% 100.50 % 97.44 % 98.88% Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 400C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

Minutes for 254th Registration Board Meeting 365

Assessment frequency (Months) Initial 3 6 9 Date of Testing 06-11-2014 11-02-2015 13-05-2015 12-08-2015 Mode of testing (F=full.) FF FF Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Long term) Appearance Yellow color oblong 30◦C ± 2◦C & 75% Complies Complies Complies Complies biconvex shape film RH. ± 5% RH. coated tablet plain from both sides Identification Positive for Sofosbuvir 30◦C ± 2◦C & 75% Retention time Retention time Retention time Retention time by HPLC. The retention RH. ± 5% RH. complies complies complies complies time of the Sample peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay. AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 915.4 mg 915.5 mg 915.2 mg 914.8 mg WEIGHT/TAB RH. ± 5% RH.

◦ ◦ LENGTH 18.80 – 19.20 mm 30 C ± 2 C & 75% 19.04 mm 19.01 mm 19.11 mm 19.15 mm RH. ± 5% RH. 8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.01 mm 9.06 mm 9.09 mm 9.07 mm WIDTH RH. ± 5% RH. 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.60 mm 6.34 mm 6.38 mm 6.35 mm THICKNESS RH. ± 5% RH NMT 30 mins. 30◦C ± 2◦C & 75% 4 mins. 4 mins 6 mins 8 mins DISINTEGRATION RH. ± 5% RH ◦C ± 2◦C & 75% DISSOLUTION 30 Not less than 80% after RH. ± 5% RH 98.39% 98.96% 98.23% 97.07% (SOFOSUBVIR ) 45 minutes 30◦C ± 2◦C & 75% 100.50 % 98.59% 98.32% 97.94% Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 300C + 20C and 75% + 5% R.H will be performed for 9 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 9 month.

Minutes for 254th Registration Board Meeting 366

1: Product Details

Product name /Generic name /Dosage form Zoval 400mg tablets Batch No. 15ZLP-1632-04-T

Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 250 Tablets (container closure packed in Alu Alu foil in a printed unit carton system) Parameters and As per Product Specifications (PharmEvo Specs) Mfg. Date May 2015 tests mentioned  Short term conditions (Accelerated) 40±2C,75±5 RH Recommended  Long term Conditions 30±2C,75±5 RH Exp Date May 2017 storage condition

Date of initiation May-2015 (API) lot no. RD/SFB/15/01 & Stability No. CN# 884

Approved by:

QC Manager: ------

Total Sample size (approx.) = 20 QA Manager: ------

Production Manager: ------

R&D Manager: ------

Minutes for 254th Registration Board Meeting 367

Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 02-05-2015 03-06-2015 02-07-2015 03-08-2015 01-11-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Accelerated) Appearance Yellow color oblong 40◦C ± 2◦C & 75% Complies Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 40◦C ± 2◦C & 75% Retention Retention Retention Retention time Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 914.7 mg 915.7 mg 914.2 mg 916.2 mg 915.3 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 40◦C ± 2◦C & 75% 19.11 mm 19.11 mm 19.09 mm 19.07 mm 19.04 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.15 mm 9.14 mm 9.15 mm 9.12 mm 9.08 mm RH. ± 5% RH. THICKNESS 6.40 – 6.90 mm 40◦C ± 2◦C & 75% 6.39 mm 6.33 mm 6.38 mm 6.34 mm 6.39 mm RH. ± 5% RH DISINTEGRATION NMT 30 mins. 40◦C ± 2◦C & 75% 4 mins. 5 mins 6 mins 7 mins 9 mins RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% 98.57 % 98.28% (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 95.89 % 92.86 % 98.04 % minutes Assay(SOFOSUBVIR ) 40◦C ± 2◦C & 75% 99.52 % 98.51 % 98.11% 97.78 % 98.09 % (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 400C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

Minutes for 254th Registration Board Meeting 368

Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 02-05-2015 03-06-2015 02-07-2015 03-08-2015 01-11-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Long term) Appearance Yellow color oblong 30◦C ± 2◦C & 75% Complies Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 30◦C ± 2◦C & 75% Retention Retention Retention Retention time Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 914.7 mg 915.3 mg 914.8 mg 915.6 mg 915.8 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 30◦C ± 2◦C & 75% 19.11 mm 19.15 mm 19.13 mm 19.05 mm 19.09 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.15 mm 9.10 mm 9.13 mm 9.16 mm 9.11 mm RH. ± 5% RH. THICKNESS 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.39 mm 6.36 mm 6.39 mm 6.39 mm 6.37 mm RH. ± 5% RH DISINTEGRATION NMT 30 mins. 30◦C ± 2◦C & 75% 4 mins. 5 mins 6 mins 6 mins 8 mins RH. ± 5% RH DISSOLUTION 30◦C ± 2◦C & 75% 98.57 % 93.97% (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 95.93 % 93.04 % 97.68 % minutes Assay(SOFOSUBVIR ) 30◦C ± 2◦C & 75% 99.52 % 99.01 % 98.56% 98.59 % 98.67 % (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 300C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

Minutes for 254th Registration Board Meeting 369

1.0 Product details:

Product name /Genric name /Dosage form Zoval 400mg tablets Batch No. 5F109

Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 24500 Tablets (container closure packed in Alu Alu foil in a printed unit carton further packed in master shipper system) Parameters and As per Product Specifications (PharmEvo Specs) Mfg. Date May 2015 tests mentioned

 Short term conditions (Accelerated) 40±2C,75±5 RH Recommended Exp Date May 2017 storage condition  Long term conditions (Real time ) 30±2C, 75±5RH

Date of initiation May- 2015 (API) lot no. RD/SFB/15/01 & Stability No. CN# 823

Approved by: Sample Taken for physical = 50 QC Manager: ------tests = 50 Sample taken for Chemical = QA Manager: ------tests Extra samples (if N/R

Production Manager: ------R&D

Manager: ------

Minutes for 254th Registration Board Meeting 370

Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 03-06-2015 23-07-2015 21-08-2015 21-09-2015 Mode of testing (F=full.) FF F F F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Accelerated) Appearance Yellow color oblong 40◦C ± 2◦C & 75% Complies Complies Complies Complies biconvex shape film RH. ± 5% RH. coated tablet plain from both sides Identification Positive for Sofosbuvir 40◦C ± 2◦C & 75% Retention Retention Retention Retention by HPLC. The retention RH. ± 5% RH. time time time time time of the Sample peak in the chromatogram of complie complie complie complie the assay preparation s s s s corresponds to that of the standard preparation as obtained in the assay. AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 912.7 mg 914.8 mg 920.1 mg 917.3 mg WEIGHT/TAB RH. ± 5% RH.

◦ ◦ LENGTH 18.80 – 19.20 mm 40 C ± 2 C & 75% 19.14 mm 19.07mm 19.11mm 19.13 mm RH. ± 5% RH. 8.80 – 9.20 mm 40◦C ± 2◦C & 75% 8.92 mm 8.97 mm 8.95 mm 8.94 mm WIDTH RH. ± 5% RH. 6.30 – 6.90 mm 40◦C ± 2◦C & 75% 6.41 mm 6.48mm 6.43mm 6.47mm THICKNESS RH. ± 5% RH NMT 30 mins. 40◦C ± 2◦C & 75% 5 mins. 4 mins 5 mins 3 mins DISINTEGRATION RH. ± 5% RH 40◦C ± 2◦C & 75% 86.04% 86.44 % 95.47 % 95.85 % DISSOLUTION Not less than 80% after RH. ± 5% RH (SOFOSUBVIR ) 45 minutes 40◦C ± 2◦C & 75% 98.45 % 100.92 % 99.49 % 100.05 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 400C + 20C and 75% + 5% R.H will be performed for 3 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 3 month.

Minutes for 254th Registration Board Meeting 371

Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 03-06-2015 23-07-2015 21-08-2015 21-09-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Long term) Appearance Yellow color oblong 30◦C ± 2◦C & 75% Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 30◦C ± 2◦C & 75% Retention Retention Retention Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay. AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 912.7 mg 915.8 mg 921.4 mg 918.4 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 30◦C ± 2◦C & 75% 19.14 mm 19.07mm 19.02mm 19.08 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 30◦C ± 2◦C & 75% 8.92 mm 9.05 mm 8.96 mm 9.03 mm RH. ± 5% RH. THICKNESS 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.41 mm 6.52 mm 6.49 mm 6.58 mm RH. ± 5% RH DISINTEGRATION NMT 30 mins. 30◦C ± 2◦C & 75% 5 mins. 3 mins 4 mins 5 mins RH. ± 5% RH DISSOLUTION 30◦C ± 2◦C & 75% 86.04% (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 84.78% 95.22% 96.56 % minutes Assay(SOFOSUBVIR ) 30◦C ± 2◦C & 75% 98.45 % 98.53 % 98.32 % 99.37 % (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 300C + 20C and 75% + 5% R.H will be performed for 3 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 3 month.

Minutes for 254th Registration Board Meeting 372

1.0 Product details:

Product name /Generic name /Dosage form Zoval 400mg tablets Batch No. 15ZVL-1565-01-T

Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 300 Tablets (container closure packed in Alu Alu foil in a printed unit carton system) Parameters and As per Product Specifications (PharmEvo Specs) Mfg. Date April 2015 tests mentioned  Short term conditions (Accelerated) 40±2C,75±5 RH Recommended  Long term Conditions 30±2C,75±5 RH Exp Date April 2017 storage condition

Date of initiation April-2015 (API) lot no. YAK-201503001R1 & Stability No. CN# 821

Approved by:

QC Manager: ------

Total Sample size (approx.) = 20 QA Manager: ------

Production Manager: ------R&D

Manager: ------

Minutes for 254th Registration Board Meeting 373

Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 7-04-2015 7-05-2015 8-06-2015 7-07-2015 7-10-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Accelerated) Appearance Yellow color oblong 40◦C ± 2◦C & 75% Complies Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 40◦C ± 2◦C & 75% Retention Retention Retention Retention time Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 914.4 mg 914.8 mg 915.6 mg 914.9 mg 914.5 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 40◦C ± 2◦C & 75% 19.08 mm 19.11 mm 19.14 mm 19.16 mm 19.13 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.02 mm 9.07 mm 9.13 mm 9.13 mm 9.05 mm RH. ± 5% RH. THICKNESS 6.40 – 6.90 mm 40◦C ± 2◦C & 75% 6.34 mm 6.37 mm 6.32 mm 6.37 mm 6.37 mm RH. ± 5% RH DISINTEGRATION NMT 40 mins. 40◦C ± 2◦C & 75% 4 mins. 4 mins 4 mins 7 mins 6 mins RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% 100.40 % 100.46 % (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 100.01% 102.51 % 101.12 % minutes Assay(SOFOSUBVIR ) 40◦C ± 2◦C & 75% 100.32 % 100.08 % 99.26% 98.88 % 98.71 % (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 400C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

Minutes for 254th Registration Board Meeting 374

Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 7-04-2015 7-05-2015 8-06-2015 7-07-2015 7-10-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Long term) Appearance Yellow color oblong 30◦C ± 2◦C & 75% Complies Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 30◦C ± 2◦C & 75% Retention Retention Retention Retention time Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 914.4 mg 914.8 mg 915.8 mg 915.2 mg 914.9 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 30◦C ± 2◦C & 75% 19.08 mm 19.05 mm 19.14 mm 19.11 mm 19.10 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.02 mm 9.09 mm 9.15 mm 9.11 mm 9.08 mm RH. ± 5% RH. THICKNESS 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.34 mm 6.36 mm 6.39 mm 6.39 mm 6.37 mm RH. ± 5% RH DISINTEGRATION NMT 30 mins. 30◦C ± 2◦C & 75% 4 mins. 4 mins 6 mins 6 mins 5 mins RH. ± 5% RH DISSOLUTION 30◦C ± 2◦C & 75% 100.30 % 101.49 % (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 100.38% 98.21 % 99.32 % minutes Assay(SOFOSUBVIR ) 30◦C ± 2◦C & 75% 100.32 % 100.23 % 99.75% 99.14 % 99.28 % (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 300C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

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1.0 Product details:

Product name /Generic name /Dosage form Zoval 400mg tablets Batch No. 15ZVL-1568-02-T

Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 300 Tablets (container closure packed in Alu Alu foil in a printed unit carton system) Parameters and As per Product Specifications (PharmEvo Specs) Mfg. Date April 2015 tests mentioned  Short term conditions (Accelerated) 40±2C,75±5 RH Recommended  Long term Conditions 30±2C,75±5 RH Exp Date April 2017 storage condition

Date of initiation April-2015 (API) lot no. YAK-201503001R1 & Stability No. CN# 825

Approved by:

QC Manager: ------

Total Sample size (approx.) = 20 QA Manager: ------

Production Manager: ------R&D

Manager: ------

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Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 10-04-2015 11-05-2015 10-06-2015 10-07-2015 10-10-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Accelerated) Appearance Yellow color oblong 40◦C ± 2◦C & 75% Complies Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 40◦C ± 2◦C & 75% Retention Retention Retention Retention time Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 915.1 mg 916.8 mg 915.3 mg 915.7 mg 914.6 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 40◦C ± 2◦C & 75% 19.04 mm 19.08 mm 19.14mm 19.11 mm 19.11 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.12 mm 9.07 mm 9.08 mm 9.13 mm 9.12 mm RH. ± 5% RH. THICKNESS 6.40 – 6.90 mm 40◦C ± 2◦C & 75% 6.35 mm 6.37 mm 6.34 mm 6.37 mm 6.39 mm RH. ± 5% RH DISINTEGRATION NMT 40 mins. 40◦C ± 2◦C & 75% 3 mins. 5 mins 5 mins 5 mins 6 mins RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% 99.18 % 93.75% (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 92.10% 96.16 % 95.08 % minutes Assay(SOFOSUBVIR ) 40◦C ± 2◦C & 75% 99.37 % 98.72 % 98.44% 98.10 % 97.06% (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 400C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

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Assessment frequency (Months) Initial 1 2 3 6 Date of Testing 10-04-2015 11-05-2015 10-06-2015 10-07-2015 10-10-2015 Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions (Long term) Appearance Yellow color oblong 30◦C ± 2◦C & 75% Complies Complies Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides Identification Positive for Sofosbuvir by 30◦C ± 2◦C & 75% Retention Retention Retention Retention time Retention time HPLC. The retention time of RH. ± 5% RH. time complies time time complies complies the Sample peak in the complies complies chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.

AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 915.1 mg 916.1 mg 916.3 mg 916.9 mg 917.4 mg WEIGHT/TAB RH. ± 5% RH. LENGTH 18.80 – 19.20 mm 30◦C ± 2◦C & 75% 19.04 mm 19.11 mm 19.05mm 19.16 mm 19.14 mm RH. ± 5% RH. WIDTH 8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.12 mm 9.09 mm 9.02 mm 9.05 mm 9.11 mm RH. ± 5% RH. THICKNESS 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.35 mm 6.39 mm 6.37 mm 6.32 mm 6.38 mm RH. ± 5% RH DISINTEGRATION NMT 30 mins. 30◦C ± 2◦C & 75% 3 mins. 4 mins 5 mins 5 mins 5 mins RH. ± 5% RH DISSOLUTION 30◦C ± 2◦C & 75% 99.18 % 98.48% (SOFOSUBVIR ) Not less than 80% after 45 RH. ± 5% RH 97.23% 90.60 % 89.66 % minutes Assay(SOFOSUBVIR ) 30◦C ± 2◦C & 75% 99.37 % 99.06 % 98.76% 98.66 % 97.30 % (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Long term stability study at 300C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.

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Documents / Data provided by the applicants (M/s PharmEvo, Karachi)

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 Yes (Attested Photocopy of certificate of API manufacturer issued by regulatory authority of both mfg. GMP provided) country of origin. 3. Protocols followed for conduction of stability study and details of Yes tests. 4. Data of 05 batches will be supported by attested respective documents Yes like chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. Yes (ADC cleared) 6. All provided documents will be attested (name, sign and stamp) for Yes ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till assigned shelf Yes life of the product.

Decision: Registration Board observed that the stability data provided by the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches from one source and from another source, stability data was not complete for 6 months for the third batch. Therefore, case was deferred till the applicant completes the requisite information (6 months real time and accelerated stability data for three batches) from the source pre- qualified by the firm.

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4. M/s Getz Pharma, Karachi

Drug Sofviget tablets (Sofosbuvir) 400 mg Source Beijing Kawin Technology Share-Holding Co. Ltd, China Storage Condition Real Time: 30 C and 75% RH Accelerated: 40 C and 75% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 3, 6 months

Batch Size 400, 325, 325 tablets No. of Batches 03 Sample Size 50 tablets Meeting Deferred in 244th and 251st meeting of Registration Board for stability studies

Stability Study Data Sheet Product Details: Product Name / Generic Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS01 name / Dosage form 400mg Yellow colored oblong shaped film coated Description of pack tablets, packed in 28 x 1 HDPE bottle, further packed Batch Size. 400 tablets (container closure system) in secondary carton. Appearance: Yellow colored oblong shaped film coated tablets, both sides plain. Parameters and test Disintegration Time: Not more than 30 minutes. Identification: The retention time of the major Mfg. Date September 2014 mentioned peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as

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obtained in the Assay. Dissolution: Not less than 75% (Q); (Q + 5% = 80%) Assay: (90.0 – 110.0)% Total Aerobic Not more than 1000 cfu/gm Microbial Count: Total Yeast & Mold Not more than 100 cfu/gm Count: Escherichia coli: Must be absent / 10gm Recommended storage Accelerated condition: 40°C ± 2°C & 75% ± 5%RH Exp. Date September 2016 conditions Real time condition: 30°C ± 2°C & 75% ± 5%RH Date of initiation & September 2014 (API) lot no. HM174C00520140812 Implementation Stability No. FS-837

Sample taken for physical tests = 40 Sample taken for Chemical tests = Sample taken for Microbiological tests = 10 Extra samples (if needed) = - Total Sample size (approx) = 50

Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36

Date of Testing Sep-14 Dec-14 Mar-15 Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F Tests (Physical, Storage Acceptance Chemical, conditions Criteria Microbiological) (Accelerated) Yellow colored oblong shaped film 40°C ± 2°C & Appearance Complies - - Complies - Complies coated tablets, both 75% ± 5%RH sides plain.

Disintegration Not more than 30 40°C ± 2°C & 1 min - - 2 min - 2 min Time minutes. 75% ± 5%RH

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The retention time of the major peak in the chromatogram of the Assay preparation

Identification corresponds to that 40°C ± 2°C & Complies - - Complies - Complies of the Standard 75% ± 5%RH preparation as obtained in the

Assay.

Not less than 75% 40°C ± 2°C & Dissolution 91.801% - - 91.040% - 96.749% (Q); (Q + 5% = 80%) 75% ± 5%RH

40°C ± 2°C & - - 97.295% - 96.760% Assay (90.0 – 110.0)% 75% ± 5%RH 96.057%

Not more than 1000 40°C ± 2°C & 0.00 0.00 Total Aerobic - - - - Microbial Count cfu/gm 75% ± 5%RH cfu/g cfu/g Not more than 100 40°C ± 2°C & 0.00 0.00 Total Yeast & - - - - Mold Count cfu/gm 75% ± 5%RH cfu/g cfu/g Must be absent / 40°C ± 2°C & Complies - - - - Complies Escherichia coli 10gm 75% ± 5%RH Analyst signature Conclusion by QA

Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36

Date of Testing Sep-14 Dec-14 Mar-15 Jun-15 Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F Tests (Physical, Storage Acceptance Chemical, conditions Criteria Microbiological) (Accelerated) Yellow colored oblong shaped film 30°C ± 2°C & Appearance Complies - - Complies - Complies Complies coated tablets, both 75% ± 5%RH sides plain.

Disintegration Not more than 30 30°C ± 2°C & 1 min - - 1 min - 2 min 1 min Time minutes. 75% ± 5%RH

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The retention time of the major peak in the chromatogram of the Assay preparation

Identification corresponds to that 30°C ± 2°C & Complies - - Complies - Complies Complies of the Standard 75% ± 5%RH preparation as obtained in the

Assay.

Not less than 75% 30°C ± 2°C & - - 96.670% - 96.626% 90.819% Dissolution (Q); (Q + 5% = 75% ± 5%RH 91.801% 80%)

30°C ± 2°C & - - 97.480% - 96.475% 101.054% Assay (90.0 – 110.0)% 75% ± 5%RH 96.057%

Not more than 1000 30°C ± 2°C & 0.00 Total Aerobic ------Microbial Count cfu/gm 75% ± 5%RH cfu/g Not more than 100 30°C ± 2°C & 0.00 Total Yeast & ------Mold Count cfu/gm 75% ± 5%RH cfu/g Must be absent / 30°C ± 2°C & Complies ------Escherichia coli 10gm 75% ± 5%RH Analyst signature Conclusion by QA

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Stability Study Data Sheet Product Details: Product Name / Generic Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS02 name / Dosage form 400mg Yellow colored oblong shaped film coated Description of pack tablets, packed in 28 x 1 HDPE bottle, further packed Batch Size. 325 tablets (container closure system) in secondary carton. Appearance: Yellow colored oblong shaped film coated tablets, both sides plain. Disintegration Time: Not more than 30 minutes. Identification: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as Parameters and test obtained in the Assay. Mfg. Date December 2014 mentioned Dissolution: Not less than 75% (Q); (Q + 5% = 80%) Assay: (90.0 – 110.0)% Total Aerobic Not more than 1000 cfu/gm Microbial Count: Total Yeast & Mold Not more than 100 cfu/gm Count: Escherichia coli: Must be absent / 10gm Recommended storage Accelerated condition: 40°C ± 2°C & 75% ± 5%RH Exp. Date December 2016 conditions Real time condition: 30°C ± 2°C & 75% ± 5%RH Date of initiation & December 2014 (API) lot no. HM174C00520140812 Implementation Stability No. FS-879

Sample taken for physical tests = 40 Sample taken for Chemical tests = Sample taken for Microbiological tests = 10 Extra samples (if needed) = - Total Sample size (approx) = 50

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Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36

Date of Testing Dec-14 Mar-15 Jun-15 Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F Tests (Physical, Storage Acceptance Chemical, conditions Criteria Microbiological) (Accelerated) Yellow colored oblong shaped film 40°C ± 2°C & Appearance Complies - - Complies - Complies coated tablets, both 75% ± 5%RH sides plain.

Disintegration Not more than 30 40°C ± 2°C & 5 min - - 3 min - 5 min Time minutes. 75% ± 5%RH

The retention time of the major peak in the chromatogram of the Assay preparation

Identification corresponds to that of 40°C ± 2°C & Complies - - Complies - Complies the Standard 75% ± 5%RH preparation as obtained in the Assay.

Not less than 75% 40°C ± 2°C & Dissolution 93.879% - - 97.105% - 97.038% (Q); (Q + 5% = 80%) 75% ± 5%RH

40°C ± 2°C & - - 97.830% - 97.754% Assay (90.0 – 110.0)% 75% ± 5%RH 95.822%

Not more than 1000 40°C ± 2°C & 0.00 0.00 Total Aerobic - - - - Microbial Count cfu/gm 75% ± 5%RH cfu/g cfu/g Not more than 100 40°C ± 2°C & 0.00 0.00 Total Yeast & - - - - Mold Count cfu/gm 75% ± 5%RH cfu/g cfu/g Must be absent / 40°C ± 2°C & Complies - - - - Complies Escherichia coli 10gm 75% ± 5%RH Analyst signature Conclusion by QA

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Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36

Date of Testing Dec-14 Mar-15 Jun-15

Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F Tests (Physical, Storage

Chemical, Acceptance Criteria conditions Microbiological) (Accelerated)

Yellow colored oblong 30°C ± 2°C & Appearance shaped film coated Complies - - Complies - Complies 75% ± 5%RH tablets, both sides plain.

Disintegration Not more than 30 30°C ± 2°C & 5 min - - 3 min - 5 min Time minutes. 75% ± 5%RH

The retention time of the major peak in the chromatogram of the Assay preparation Identification corresponds to that of 30°C ± 2°C & Complies - - Complies - Complies the Standard preparation 75% ± 5%RH as obtained in the Assay.

Not less than 75% (Q); 30°C ± 2°C & Dissolution 93.879% - - 96.238% - 94.805% (Q + 5% = 80%) 75% ± 5%RH

30°C ± 2°C & - - 97.895% - 99.785% Assay (90.0 – 110.0)% 75% ± 5%RH 95.822%

Not more than 1000 30°C ± 2°C & 0.00 Total Aerobic - - - - - Microbial Count cfu/gm 75% ± 5%RH cfu/g Not more than 100 30°C ± 2°C & 0.00 Total Yeast & - - - - - Mold Count cfu/gm 75% ± 5%RH cfu/g 30°C ± 2°C & Must be absent / 10gm Complies - - - - - Escherichia coli 75% ± 5%RH Analyst signature Conclusion by QA

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Stability Study Data Sheet

Product Details:

Product Name / Generic Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS03 name / Dosage form 400mg Yellow colored oblong shaped film coated tablets, Description of pack packed in 28 x 1 HDPE bottle, further packed in secondary Batch Size. 325 tablets (container closure system) carton. Appearance: Yellow colored oblong shaped film coated tablets, both sides plain. Disintegration Time: Not more than 30 minutes. Identification: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as Parameters and test obtained in the Assay. Mfg. Date April 2015 mentioned Dissolution: Not less than 75% (Q); (Q + 5% = 80%) Assay: (90.0 – 110.0)% Total Aerobic Not more than 1000 cfu/gm Microbial Count: Total Yeast & Mold Not more than 100 cfu/gm Count: Escherichia coli: Must be absent / 10gm Recommended storage Accelerated condition: 40°C ± 2°C & 75% ± 5%RH Exp. Date April 2017 conditions Real time condition: 30°C ± 2°C & 75% ± 5%RH Date of initiation & April 2015 (API) lot no. 20141206 Implementation Stability No. FS-056-15

Sample taken for physical tests = 40 Sample taken for Chemical tests = Sample taken for Microbiological tests = 10 Extra samples (if needed) = - Total Sample size (approx) = 50

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Assessment frequency (weeks) Initial 1 2 3 4 6 6 9 12 16 20 24 36 Oct-15 Date of Testing Apr-15 Aug-15 Oct-15 (Repeat) Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F F Tests (Physical, Storage Chemical, Acceptance Criteria conditions Microbiological) (Accelerated)

Yellow colored oblong 40°C ± 2°C & Appearance shaped film coated Complies - - Complies Complies Complies 75% ± 5%RH tablets, both sides plain.

Disintegration Not more than 30 40°C ± 2°C & 2 min - - 3 min 2 min 2.0 min Time minutes. 75% ± 5%RH

The retention time of the major peak in the chromatogram of the Assay preparation Identification 40°C ± 2°C & corresponds to that of Complies - - Complies Complies Complies the Standard preparation 75% ± 5%RH as obtained in the Assay.

Not less than 75% (Q); 40°C ± 2°C & Dissolution 93.804% - - 88.759% 94.510% 91.690% (Q + 5% = 80%) 75% ± 5%RH

40°C ± 2°C & - - 96.231% 102.390% 99.053% Assay (90.0 – 110.0)% 75% ± 5%RH 97.798%

Not more than 1000 40°C ± 2°C & 0.00 Total Aerobic - - - - - Microbial Count cfu/gm 75% ± 5%RH cfu/g Not more than 100 40°C ± 2°C & 0.00 Total Yeast & - - - - - Mold Count cfu/gm 75% ± 5%RH cfu/g 40°C ± 2°C & Escherichia coli Must be absent / 10gm Complies - - - - - 75% ± 5%RH

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Analyst signature Conclusion by QA Results obtained from accelerated stability testing of Sofviget (Sofosbuvir) Tablets 400mg after 06 months showed no significant effect or change over time. Stability study results were evaluated and all tests are in compliance with the specifications and no degradation has been reported.

Assessment frequency (weeks) Initial 1 2 3 4 6 6 9 12 16 20 24 36 Oct-15 Date of Testing Apr-15 Aug-15 Oct-15 (Repeat) Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F F Tests (Physical, Storage Chemical, Acceptance Criteria conditions Microbiological) (Accelerated)

Yellow colored oblong 30°C ± 2°C & Appearance shaped film coated Complies - - Complies Complies Complies 75% ± 5%RH tablets, both sides plain.

Disintegration Not more than 30 30°C ± 2°C & 2 min - - 2 min 2 min 2 min Time minutes. 75% ± 5%RH

The retention time of the major peak in the chromatogram of the Assay preparation Identification 30°C ± 2°C & corresponds to that of Complies - - Complies Complies Complies the Standard preparation 75% ± 5%RH as obtained in the Assay.

Not less than 75% (Q); 30°C ± 2°C & Dissolution 93.804% - - 91.359% 94.010% 91.490% (Q + 5% = 80%) 75% ± 5%RH

30°C ± 2°C & - - 100.691% 102.200% 99.531% Assay (90.0 – 110.0)% 75% ± 5%RH 97.798%

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Total Aerobic Not more than 1000 30°C ± 2°C & 0.00 - - - - - Microbial Count cfu/gm 75% ± 5%RH cfu/g Total Yeast & Not more than 100 30°C ± 2°C & 0.00 - - - - - Mold Count cfu/gm 75% ± 5%RH cfu/g 30°C ± 2°C & Escherichia coli Must be absent / 10gm Complies - - - - - 75% ± 5%RH Analyst signature Conclusion by QA

Documents / Data provided by the applicants (M/s Getz Pharma, Karachi)

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 Yes certificate of API manufacturer issued by regulatory authority of country of origin. 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 Yes chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. Yes (ADC cleared) 6. All provided documents will be attested (name, sign and stamp) for ensuring Yes authenticity of data / documents. 7. Commitment to continue real time stability study till assigned shelf life of the Yes product.

Decision: Registration Board observed that the stability data provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to

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the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. Further, the panel comprising of Brig. Muzamil H. Najmi Member Registration Board, Dr. Obaidullah, DDG R I and Dr. Saifur Rehman Khattak, Federal Government Analyst, CDL, Karachi shall also inspect the premesis to ensure authenticity of data.

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Item No. III: Cases referred by QA< Division.

A. Deferred Cases

Case No. 01: Tyno SF Cough Syrup of M/s Reko Pharmacal, Lahore and Dextromethorphan Cough Syrup of M/s Ethical Lab.

Report of PQCB:

The Secretary, Provincial Quality Control Board, (PQCB) Punjab had reported that the PQCB Board, in its meetings held on 29-12-2012 and 11-01-2013 considered the case of substandard Dextromethorphan Active Pharmaceutical Ingredients, Batch No. DMR-02-12-029 and DMR-02-12-030 Manufactured by M/s Konduskar Laboratories (Pvt) Ltd., MIDC-India, was being used for manufacturing of Tyno SF Cough Syrup by M/s Reko Pharmacal, Lahore and Dextromethorphan Cough Syrup by M/s Ethical Labs Lahore respectively. The samples were drawn by Drug Inspector, Allama Iqbal Town, Lahore from manufacturer’s premises and the team of Provincial Health Department sealed the firm’s premises on 25-11-2012. The Provincial Health Department de-sealed the factory on 27-11-2012 on administrative grounds.

Action Taken by DRAP:

As per record/ information available with DRAP, the Board was apprised background of the case is as under.

1. The drugs sales outlets in Lahore were randomly checked by Federal Inspector of Drugs for availability of the said drug but no stocks were found.

2. A team of Federal Inspector of Drugs and Assistant Drug Controllers inspected the firm on the same day i.e 27-11-2012 when the company was de-sealed by the Provincial Inspector. The FID & ADC checked Production and Quality Control record of the suspected batches of Tyno SF Cough Syrup was checked. Samples of the four suspected batches of the Syrup and active raw materials used in their manufacturing were drawn for test/ analysis by the Federal Government Analyst. The available stocks of Tyno SF Cough Syrup were ordered “not to dispose off” by the FID while the active raw material was sealed by the Provincial Drug Inspector.

3. The Federal Government Analyst subsequently declared four suspected batches of Tyno SF Cough Syrup and the samples of active raw materials Dextromethorphan (Batch No. DMR-02-12-029) used in their manufacturing as of standard quality manufacturing. The provincial health authorities later furnished a sub-standard test repots of DTL Punjab in respect of the same batch Dextromethorphan raw material, imported from Konduskar Laboratories by M/s Reko,

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4. In December, 2012 another incidence was reported regarding deaths in Gujranwala due to unknown poisoning, the Punjab health authorities reported that Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Lab as suspected drugs. During further investigation it was found that the source of Dextromethorphan raw material, i.e. M/s Kundoskar India, utilized in these products was the same as that of Tyno SF Cough Syrup of M/s Reko.

5. A joint inspection (with the provincial health authorities) of M/s Ethical Labs Lahore, whose syrup viz Dextromethorphan Cough Syrup and Cocil cough Syrup (containing Dextromethorphan) were suspected to be involved, was also carried out on 28-12-2012 and the production and quality control record was thoroughly cheeked by the inspection team. The entire stocks of suspected drugs present in the premises were order not to dispose off and 19 different samples of finished drugs and raw materials were taken for test/ analysis by the provincial inspectors. The Federal Inspector of Drugs also drew samples of suspected drugs from the firm’s premises. The reports of investigation of cause of death are awaited. The Syrup Section and suspected raw materials of the firm were sealed by the provincial drug inspectors.

6. There have been a number of news reports that all the victims were drug addicts and there is possibility that they have taken some other drugs or narcotics along with the Cough Syrup in excessive quantities. The Forensic Toxicology Analysis Report issued by Home Department, Government of Punjab, also reported Opiates, Cannabinoids, Ethanol, and other sedative/ psychotropic substances in the samples drawn from 11 victims, suggesting concomitant ingestion of narcotics and other related substances by them.

7. The test reports of the samples of finished products and raw materials used in these cough syrups, sent by Punjab Government to UK for testing, revealed that the two batches of Dextromethrophan (DMR 02-12-029 & DMR 02/12-030) raw material imported from M/s Konduskar, India contains heavy contents of Levomethorphan (up to 22%), which is the semi finished form of Dextromethorphan. 8. While the role of Levomethorphan and other narcotics / psychotropic drugs detected in the victim’s samples is being investigated, both the Provincial Government and Drug Regulatory Authority of Pakistan has taken necessary actions to confiscate the imported raw material and finished products from the market.

The Central Licensing Board took up the matter in its 231st Meeting held on 30-01- 2013, and after hearing representatives of M/s Reko Pharmacal and Ethical Labs took following decisions.

i. Import of any raw material / drug form M/s Konduskar India is banned forthwith. Minutes for 254th Registration Board Meeting 393

ii. WHO Pakistan may be approached with the request to take up the matter with the Indian authorities through WHO India. iii. Suspension of License of Oral Liquid / Syrup Section of M/s Reko Pharmacal for one year or till completion of investigation and decision by the competent forum, whichever is earlier.

iv. Suspension of License of Oral Liquid / Syrup Section of M/s Ethical Labs for one year or till completion of investigation and decision by the competent forum, whichever is earlier.

v. Recommendations to the Drug Registration Board for Cancellation of Registration of Tyno SF Cough Syrup of M/s Reko Pharmacal and Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs.

vi. Detail panel GMP inspection of the M/s Reko Pharmacal and M/s Ethical Labs

The Licensing Board further decided to take up the matter again after completion of investigation by the relevant quarters.

The Central Licensing Board after review of the available details of the case noted that the matter of excessive consumption of the Cough Syrups along with narcotics and other related substances by the victims requires to be properly investigated in order to find actual cause of deaths and subsequent fixation of responsibility.

Decision:-

The CLB took the following decisions.

i. While endorsing the ban on import from M/s Konduskar India, the Board recommended for involving trade bodies and diplomatic channels for taking up the matter with the Indian authorities.

ii. Ministry of Commerce may be approached with the recommendation that a cautious approach made may be adopted for granting Most Favored Nation (MFN) status to the India in view of the substandard imports. iii. A committee with following composition is constituted to thoroughly investigate the matter and submit its finding and recommendations to the Board on priority basis. a. Representative from DRAP b. Representative from the Government of Punjab c. Two Experts in Pharmaceutical Sciences d. Any other co-optive member the committee may require

iv. Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till completion of investigation and decision by the competent forum.

Minutes for 254th Registration Board Meeting 394

v. Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs till completion of investigation and decision by the competent forum.

Consideration of the Case by Registration Board:

The Drug Registration Board in its 237th meeting held on 26-02-2013 considered in the light of recommendation of the Secretary, Provincial Quality Control Board (PQCB), Punjab and Central Licensing Board. The Registration Board in its 237th meeting taken the following decisions.

 While endorsing the ban on import from M/s Konduskar India, the Board recommended for also involving trade bodies and diplomatic channels for taking up the matter with the Indian authorities.

 Ministry of Commerce may be approached with the recommendation that a cautious approach made may be adopted for granting Most Favored Nation (MFN) status to the India in view of the substandard imports.

 A committee with following composition is constituted to thoroughly investigate the matter and submit its finding and recommendations to the Board on priority basis. a. Representative from DRAP b. Representative from the Government of Punjab c. Two Experts in Pharmaceutical Sciences d. Any other co-optive member the committee may require

 Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till completion of investigation and decision by the competent forum.

 Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs till completion of investigation and decision by the competent forum.

In consequence of the orders of DRB, following committee was constituted by CEO DRAP.

S.No Name Designation 1. Syed Shaid Nasir Member Appellate Board Chairman Committee 2. Professor Dr. Bashir Ahmed Member 3. Professor Muhmmad S. Iqbal Member 4. Mr. Asim Rauf DDG, Secretary/Coordinator of the Committee 5. Dr. Saif ur Rehman Kahttak Member

The above committee has sent a report for the registration board to considered the conclusion of the report is reproduce here under for kind information of DRB.

Minutes for 254th Registration Board Meeting 395

The committee in its report based on to the facts, findings, review of documents, analysis of different reports and discussions based on scientific facts the committee has reached the conclusion that suspected batches of the products i.e. Tyno SF cough syrup and Dextromethorphan cough syrup manufactured by M/s. Reko Pharmacal, Lahore and M/s Ethical laboratories Lahore respectively meet the Pharmacopoeal requirements, hence, these firms cannot be held responsible for the loss of precious lives which occurred in two incidents. The deaths are attributed to overdosing of Dextromethorphan and combining of other narcotic CNS depressants/noxious substances with the Tyno SF syrup and Dextromethorphan syrup.

The case along with the committee report was placed before 245th meeting of Registration Board. The Board discussed the case at length and decided as under:-

“Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting”.

The case was again placed before registration board in its 246th meeting who decided the case as under:-

“Registration Board again decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting”.

The Registration Board in its 246th meeting decided the case as under:-

“Registration Board again decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting.”

The Director DTL Lahore Mr Jamil Anwer also the member of Registration Board informed in writing that these Firms have withdrawn their Writ Petitions at Lahore.

The case was considered by the Registration Board in its 248th meeting held on 18th-19th March, 2015.

2. The Board, in view of the case background decided as under:-

“Registration Board discussed the matter at length in the light of above proceedings of the case. Mr. Jamil Anwer, Director DTL Lahore showed his reservations on the report of the Committee with the following observations as under:-

i. The panel does not have any of the members from the Government of the Punjab, Health Department. Minutes for 254th Registration Board Meeting 396

ii. The adverse reports of DTLs Punjab, Appellate laboratory NIH, Islamabad, HEJ & laboratories of UK (MHRA) has not been reflected in the panel /Committee’s report.

iii. Mr. Jamil Anwer Director DTL Lahore further apprised the Board that he had been part of the proceedings in instant case when this sad incident happened and will share the factual position of the case before Registration Board.

iv. Mr. Jamil Anwer Director DTL Lahore was asked by the Board to send the documentary evidences of facts of this case to Secretary Registration Board, so that same may also be incorporated.

v. The matter is deferred for next meeting of Registration Board”.

The Honorable Member of the Board (Mr. Jamil Anwar Director DTL Lahore) has not furnished documentary evidences of facts of this case. Accordingly the case was submitted again for consideration/appraisal/decision of the Board in its 249th meeting held on 19-05-2015.

“Due to paucity of time the Board deferred the case till next meeting of the Registration Board.

The Case is again submitted for the appraisal of the Board. The Registration Board in its 250th meeting decided as under:-

“The Board has decided and directed to QC Section to contact with Mr. Jamil Anwar to furnish documentary evidences of facts of this case.

Current Status:

The Honorable Member Registration Board (Mr. Jamil Anwar) has given the copies of test reports which indicate that there is not pure Dextromethorphan HBr rather a racemic mixture and also contains other Isomer in the raw material and in dosage form (syrup). The Honorable member may be requested to explain and apprised Board. The Case is submitted for the appraisal of the Board, please.

Decision: Registration Board deferred the case and decided to discuss the matter in the presence of Mr. Jamil Anwar who will present his report before the Registration Board”.

Minutes for 254th Registration Board Meeting 397

Case No.02 Manufacture and Supply of Sub-Standard Hepaferon Injection By M/S Pharmedic Laboratories (Pvt) Ltd , Lahore- To Govt of Khyber Pakhtoon Khawa

The Registration Board in its 248h meeting held on 18th and 19th March 2015 considered the case of M/s Pharmadic Laboratories (Pvt) Ltd Lahore.

Background:

The background of the case is that the Registration Board in its 248th meeting held on 18th-19th March, 2015 discussed the case of supply of sub-standard Hepaferon Injection (Interferon) to Government of Khyber Pakhtunkhawa Batch No.80-87. The Federal Inspector of Drugs (FID) Peshawar was directed by the Registration Board to submit the certified copies of decisions of Drug Court Peshawar and Peshawar High Court, Peshawar in the instant case. The FID has submitted the copies of the orders the Peshawar High Court, Peshawar and the copies of decision of Drug Court Khyber Pakhtunkhwa, Peshawar The Board after thorough deliberations and in the light of decisions of the Courts and view point of the member from the M/o Law Justice and Human Rights decided the case as under:-

“Registration Board was briefed about the background of the case. SheikhSarfraz Ahmad, representative from Ministry of Law was of the view that after the decision of the Drug Court Peshawar a fresh reference requires to be sent to Law Division for seeking opinion. The Board agreed to the proposal”.

Decision: The Drugs Registration Board decided that the opinion of Law Division may be solicited in the light of decision of the Drug Court, Khyber Pakhtunkhawa, and Peshawar which are self explanatory in which the Honorable Drug Court ordered that the complaint of the prosecution is dismissed.

Keeping in view of the decision of the Drug Court Khyber Pakhtunkhawa, Peshawar the M/o Law Justice and Human Rights is requested to furnish view/ comments as whether the responsibility fixed by Federal Inspector of Drugs, Peshawar under Section 23(1)(a)(v)(vii) and 23(1)(a)(vii), 23(1)(b)(f) of Drugs Act, 1976 for prosecution may be set aside after the decision of the Drug Court Khyber Pakhtunkhawa, Peshawar or otherwise Accordingly a U.O note to Ministry of Law & Justice have been forwarded for taken comments on the subject issue. The comments are awaited.

The case was submitted again for consideration/appraisal/decision of the Board in its 249th meeting held on 19-05-2015.

“Due to paucity of time the Board deferred the case till next meeting of the Registration Board.

The Case is again submitted for the appraisal of the Board, The Registration Board in its 250th meeting decided as under:- Minutes for 254th Registration Board Meeting 398

“The Board has decided to submit reply received from the Ministry of Law Division to the concerned FID for action, as directed.

Reply of the Ministry of Law & Justice:

“The referring department had a good case for filing appeal against acquittal in this case in terms of section 417 Cr.P.C subject to limitation. Now more than one year as passed therefore at this belated stage the proposed application, if filed the same shall be decided on limitation, However by taking a chance the department may consult the Additional Attorney General Peshawar in filing of appeal under section 417 r/w section 561-A Cr.P.C along with application for condonation of delay of delay in the matter if he agree then he may assign this case to any Law Officer”.

Decision: Report was being prepared both by the Federal Inspector of Drugs and Provincial Drug Inspector for submission the Honorable Court. When the investigation was under process by FID and Provincial Drug Inspector completed his investigation is submitted before the Court on the basis of report submitted by Provincial Drug Inspector the court acquitted the accused Later when the report of FID was completed, the time for filing appeal had also lapsed. In this case Federal Drug Inspector should have intervened through Peshawar High Court for stopping the drug court from announcing its decision till the time the report of Federal Inspector of Drug was completed this was must done.

Presently the accused stand acquitted and Board can not ensure notice to the accused on the here of report of FID because the accused stand acquitted by the Court

The Law division has decided to consult Deputy Attorney General (DAG) for filing application before the court for already condonation of delay in order to file an appeal.

The Board has decided to consult the DAG through Legal Affairs Division of DRAP for filing application on condo nation of delay

Case. No.03. Supply of Substandard/Adulterated Injection Ofcil 100ml to DHQ Hospital Hafizabad (25000 vials and M/s Medisearch Pharma Pvt Ltd 5Km Raiwind Manga Road Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad.

The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad has forwarded two recommendations to DRAP as under:-

i. The Federal Government Cancel the Drug Manufacturing License of M/s Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Sub-standard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM,

Minutes for 254th Registration Board Meeting 399

Raiwind Manga Road, Lahore which supplied substandard Almajax 120ml Suspension to DHQ Hospital Hafizabad (35600 bottles).

ii. The Federal Government Cancel the Registrations of the said drugs of M/s Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.

Brief Background

The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax Suspension, and statement of the Drug Inspector observed that this is a criminal negligence on the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB) observed that there is a dire need to take quick action against the said firms to safeguard the public health at large and submitted the above mentioned recommendations.

The case is placed before Registration Board for decision on the recommendations of (PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these firms as per law with the proposal that recommendations may also be send to Division of Licensing for further necessary action at their end so that public health may be saved from risk.

Decision of Drug Registration Board:-

“To get the complete investigation along with all the reports and case background from the Secretary Provincial Quality Control Board Health Department Government of Punjab Lahore through the DDG (E&M) Lahore.

a. The area FID Lahore will be asked to submit the case background in writing along with all relevant reports for perusal of the Registration Board for decision.

b. The Board further decided the case shall be forwarded to Directorate of Licensing for further necessary action in the light of recommendation of the Provincial Quality Control Board (PQCB) Punjab.

The decision/reminders have been again conveyed to DDG (E&M) Lahore and FID Lahore the report is awaited.

The case was submitted again for consideration of the Board in its 249th meeting held on 19-05- 2015 and decided as follows:

“Due to paucity of time the Board deferred the case till next meeting of the Registration Board”.

The Case is again submitted for the appraisal of the Board, The Registration Board in its 250th meeting decided as under:-

Minutes for 254th Registration Board Meeting 400

“The Board has decided to send reminders to DDG (E&M) Lahore and FID Lahore for the submission of the report”.

The Investigation/Inspection Report M/s Medisearch Pharma is submitted for perusal please. Current Status: The DDG (E&M) Lahore Dr. Sheikh Akhtar Hussain, Mr. Asim Rauf FID Lahore and Syed Zia Hussnain FID Lahore, inspected the firm M/s Mediceena Pharma on 13-02-2015 and M/s Medisearch Pharma inspected on 12-01-2015 and made investigation reports”.

“The DDG (E&M) Lahore Dr. Sheikh Akhtar Hussain, has submitted the investigation reports for the manufacturing units i.e. M/s Medisearch Pharma (Pvt) Ltd 5-Km Riwind Road Lahore and M/s Mediceena Pharma (Pvt) Ltd 27 K-m Riwind Road, Lahore. In the matter of Supply of Substandard/Adulterated Injection Ofcil 100ml to DHQ Hospital Hafizabad and M/s Medisearch Pharma Pvt Ltd 5Km Raiwind Manga Road Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad.

“The panel concluded in their report dated 13-02-2015 of inspection M/s. Medisearch Pharma “Firm was non-operational at the time of inspection. After detailed inspection of the firm and evaluation of documents/data submitted by the firm thereafter including BMRs, SOPs, Certificate of analysis etc has revealed certain gaps in the Quality Assurance system. Firm made observation regarding storage conditions at DHQ Hafiz Abad. Report with annexure is submitted along with enclosures for consideration of board concerned under Drugs Act 1976/DRAP Act 2012.”

The DDG (E&M) Lahore Dr. Sheikh Akhtar Hussain, Mr. Asim Rauf FID Lahore and Syed Zia Hussnain FID Lahore, inspected the firm M/s Mediceena Pharma on 13-02-2015 and concluded as Investigation/Inspection Report of M/s Medicenena Pharma is submitted for perusal please. “The firm has developed SOPs and systems to manufacture the drug under reference. Firm has satisfactory compliance of GMP with reference to manufacturing section of drug under reference. cGMP is continuous day to day process which require consistent efforts. Storage conditions at hospital under reference may have also some impact on the product under reference as stated by the firm. Court observations are also enclosed pertaining to this case annexed at annexure at serial No.4 is submitted along with enlocsures of board concerned under Drugs Act 1976/DRAP Act 2012.”

Decision: Registration Board decided as follows:

a. To give personal hearing to both the firms. b. The case shall be forwarded to Directorate of Licensing for further necessary action in the light of recommendation of the Provincial Quality Control Board (PQCB) Punjab.

Minutes for 254th Registration Board Meeting 401

Case No.4: Manufacture and Sale of Adulterated & Substandard Phenviler Injection, Batch No. J-1913, By M/S Ahsons Drug Company, Tando Adam-Sindh F. No. 03- 27/2015-QC.

The Federal Government Analyst, CDL Karachi vide which sample of subject cited drug has been declared Substandard vide test report No. R.KQ.81/2015 dated 06th March 2015. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Description:- Colourless Solution in ambered glass ampoule containing visible black particles. Does not comply.

Remarks:- The sample is “Adulterated and Sub-Standard” under the Drug Act 1976

The FID served an explanation letter to the firm. The company in response vide their reply dated 30-03-2015 did not challenge the report and has submitted as under:

i. That during optical checking of the said batch of the Drug a few rejected ampoules were unfortunately mixed up with the released ones and ultimately packed unintentionally. ii. That investigation was conducted to ascertain the source of black particles and no deviation was found during any stage of production and that the firm is taking extra care during washing of ampoules. iii. That since registration of the product i.e. 1999, no such type of complaint was launched from market/customers or any regulatory authority. iv. That the whole batch has been voluntarily withheld and recalled back and quarantined in factory premises till further instructions of the authorities. v. That the firm has requested to withdraw this case in the light of aforesaid submission etc.

The FID after pursuing the firm’s reply has furnished names of following Directors and Technical Staff of the firm for violation of Section 23(1)(a)(iv) & 23(1)(a)(v) of Drugs Act, 1976.and has recommended:-

a. Cancellation of registration of drug under reference. b. Permission for prosecution against the above name persons of the company.

i. M/s Ahsons Drug Company, T/1, SITE, Tando Adam, Sindh. ii. Abdul Wahab Ansari, Managing Director of the firm. iii. Syed Anwar Ali Bukhari, Quality Control Manager. iv. Tanvir Ahmed Memon, Production Incharge.

. As per procedure show cause notices was issued to the firm and accused persons of the firm offering opportunity of personal hearing before the Drug Registration Board. The case was submitted to the Board in its 249th meeting held on 19-05-2015 for consideration and further directions in the matter. Minutes for 254th Registration Board Meeting 402

Due to paucity of time the Board deferred the case till next meeting of the Registration Board

The responsible persons of the firm have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the FID for the Phenviler Injection, Batch No. J-1913, By M/S Ahsons Drug Company, Tando Adam- Sindh.

Case No.05 Manufacture and Sale of Substandard Synocip 250mg Tablets Batch No. T- 4019 By M/s Synchro Pharmaceuticals Lahore. No.F.3-59/2014-(QC)

The sample of Synocip 250mg Tablet Batch No. T-4019 manufactured by M/s Synchro Pharmaceutical Lahore, drawn by FID Lahore-I on 17-10-2014 from manufacturer premises were declared substandard by Federal Government Analyst vide Test report No. LHR.258/2014 dated 16-12-2014. A letter was sent to FID on 30-12-2014 and 23-01-2015 by DRAP Islamabad. An explanation letter was issued by the FID to the firm. The firm had requested Appellate Testing under Section 22(5) of Drugs Act, 1976 from Appellate Lab, NIH, Islamabad. The Appellate Laboratory also declared the sample as of Sub-standard quality vide its test report No. 01-MNHSR/2015 dated 19 March 2015. The results of the CDL and NIH on the basis of which the drug sample has been declared substandard & Misbranded are reproduced as under:-

Substandard with regard to Dissolution Test.

(CDL Result) Stage-1

Tablet No. (%)age. 01. 60.23 02. 63.32 03. 54.56 04 67.09 05. 74.47 06 61.26

Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 75+5=80%

Stage-2

Tablet No. (%)age. 01. 91.68 Minutes for 254th Registration Board Meeting 403

02. 57.039 03. 48.57 04 65.42 05. 60.57 06 65.64

Average of 12 units = 769.849/12=64.154%

Limits for (Stage-2):- Average of 12 units (S1+S2) is equal to or greater than Q (75%) and no unit is less than Q-15% (75-15=60%)

Does not comply with USP 37.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.

Substandard with regard to Dissolution Test.

(Appellate Testing Result)

Dissolution Test Determined amount: 53.16% Limits: Not less than 80% of the stated amount Does not comply with USP-32.

Remarks:- The sample is of “Substandard” quality on the basis of tests performed.

As per procedure show cause notices were issued to the firm and accused persons of the firm offering opportunity of personal hearing before the Registration Board.. They were also called for personal hearing before the Registration Board in its 249th meeting.

Decision:-

The case was presented before the Registration Board in its 249th meeting on 19-05-2015. The Board in the light of personal hearing of Mr. Abbas But General Manager on behalf of CEO of the firm, deliberations, available record and facts of the case decided as under:-

i. Deferred the case till next meeting on the request of the representative of the firm as it was submitted that CEO of the firms is seriously ill.

ii. Stopped the production of the product under reference till the decision of the case.

The responsible persons of the firm was called for personal hearing in the meeting of 254th meeting of DRB and no person came to defend the case on behalf of the firm.

Decision: Registration Board decided as follows: Minutes for 254th Registration Board Meeting 404

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board.

ii. To get the recalled status and report from the area FID for the Synocip 250mg Tablets Batch No. T-4019 By M/s Synchro Pharmaceuticals Lahore.

B. New Cases

Case No.06 Manufacture & Sale of Sub-Standard Drug-Enervin Syrup Batch No.F739 By M/S Genix Pharma (Pvt) Ltd Karachi.

The sample of Enervin Syrup, Batch No. F739, Manufactured by M/s Genix Pharma (Pvt) Ltd Karachi, drawn by FID-I Karachi, from manufacturing premises on 17-12-2014, was declared Substandard vide CDL’s test report No.KQ.571/2014, dated 23rd February 2015, by Federal Government Analyst, CDL, Karachi. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Assay for Determined amount/5ml Statedamount/5ml Percentage

L-Ornithine L-aspartate: 240.768 mg 300.0mg 80.256%

Limits:- 90.0 to 110.0% Does Not Comply.

Nicotinamide:- 19.211 mg 25.0 mg 76.845%

Limits:- 90.0 to 110.0% Does Not Comply.

Vitamin B2: 0.755 mg 1.0 mg 75.50%

Limits:- 90.0 to 110.0% Does Not Comply.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard on the basis of PH vide their test report 019-MNHSR/2015 dated 16th June 2015.

Assay for Determined Limit

PH. 6.3 5.0-6.0

Does Not Comply with manufacturer specification .

Minutes for 254th Registration Board Meeting 405

The names of the following persons of the firm have been furnished by the FID along with its report.

i. M/s Genix Pharma (Pvt) Ltd Karachi. ii. Ch. Muhammad Israr Sharif, (M.D), iii. Dr. Azhar Hussain (Sr. Production Manager), iv. Maqsood-ur-Rehman (Controller, Quality Control)

02. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Enervin Syrup Batch No.F739 By M/S Genix Pharma (Pvt) Ltd Karachi.

Case No.07 Manufacture and Sale of Substandard Arycin 250mg Tablets Batch No. 067 Manufactured by M/s Nawabsons Laboratories (Pvt) Ltd., Lahore.

The Federal Inspector of Drugs, Lahore at Faisalabad drew sample of the drug “Arycin 250mg” (Erythromycin as stearate) Tablets Batch No. 067 Manufactured by M/s Nawabsons Laboratories (Pvt) Ltd., Lahore. under Section 18 of the Drugs Act, 1976, from manufacture premises on 31-03-2014. The Sample was sent to the CDL, Karachi for test/analysis. The Federal Government Analyst, declared the sample substandard on the basis of assay vide test/analysis report No. LHR.98/2014 dated 29th May 2014 are reproduce as under:- Assay for Determined amount/tablet Statedamount/5ml Percentage

Erythromycin as Stearate: 183.62mg 250.0mg 73.45% Limits:- 90.0% to 120.0% Does not comply

The FID has concluded that the manufacturer is guilty of manufacturing Substandard quality drug and has contravened Section 23 of Drugs Act 1976. Names of the following responsible persons are as under:-

i. M/s Nawabsons Laboratories (Pvt) Ltd., Lahore. ii. Mr. Akhtar Hussain Bhutta, Chief Executive officer of the firm. iii. Mr. Arjumand Akhtar Bhutta, Production Incharge, iv Mr. Nadeem Akhtar Bhutta, Quality Control Incharge,

Minutes for 254th Registration Board Meeting 406

As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

In response to show cause notice dated 31-05-2015 the firm requested for personal hearing before the Registration Board to explain their position..

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Arycin 250mg Tablets Batch No. 067 Manufactured by M/s Nawabsons Laboratories (Pvt) Ltd., Lahore.

Case No.08 Manufacture & Sale of Substandard Drugs Lumerax Forte Tablets, Batch No. DH-04 by M/s Sante (Pvt) Ltd, Karachi.

The FID Hyderabad at Karachi, on 26-05-2014, drew samples of Lumerax Forte Tablets Batch DH-04, manufactured by M/s Sante (Pvt) Ltd, Karachi from manufacturer’s premises for test/analysis. The samples were declared substandard by the F.G Analyst vide Test Report No.KQ.289/2014 dated 10-07-2014.

Assay for Determined amount/tablet Stated amount/tablet Percentage

Artemether: 34.224 mg 40.0mg 85.56% Not less than 90.0% Does not comply

Lumefentrine 252.024md 240.0mg 105.01% Not less than 90% complies

Limits:- Not less than 90.0% Does not comply

In response to FID explanation letter the firm did not agree with the CDL’s test report and has requested that the sample may be sent for re-testing by the Appellate Laboratory as per Section 22(5) of Drugs Act 1976.

The drug sample under reference was sent to the Appellate Lab for retesting under Section 22(5) of the Drugs Act 1976 on the request of the firm. The Appellate Lab was requested to perform complete test/ analysis of the drug sample as per Drugs Act 1976 and rules frame thereunder. However tests of identification and assay of one of the active ingredient i.e. Artemether has been carried out only along with weight variation test of the product. Tests of Disintegration Time, Identification and Assay of other API i.e. Lumefantrine (as done by CDL Karachi) have not been performed by the Appellate Lab.

Minutes for 254th Registration Board Meeting 407

The drug sample has been declared of standard quality on the basis of tests performed (i.e. partial testing) by the Appellate Lab vide its report No. 018-MNHSR/2014 dated 10-10- 2014.

Decision: Registration Board deffered the case duw to paucity of time.

Case No.09: Manufacture & Sale of Substandard Drug- Baxterol Suspension (Paracetamol) Batch No.BXT014 By M/S Baxter Pharmaceuticals Karachi F. No. 3-04/2015-QC

The Sample of Baxterol Suspension Batch No. BXT014 manufactured by M/s Baxter Pharmaceuticals, Karachi. was taken by FID Hyderabad at Karachi, on 17th December 2014 from manufacturer’s premises was declared substandard by Federal Government Analyst, CDL Karachi vide Test Report No. KQ.552/2014 dated 9th January 2015. The result of CDL on the basis of which sample under reference has been declared substandard on the basis of assay are reproduced as under:-

Result of CDL

Assay for Determined amount/5ml Statedamount/5ml Percentage

Paracetamol 86.612mg 120.0mg 72.177%

Limits:- 90.0% to 110.0% Does not comply.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

The firm requested for Appellate Testing. Result of NIH

The result of the NIH on the basis of which sample under reference has been declared sub- standard are reproduced as follows:-

Assay Stated Found Percentage

Paracetamol 120.0mg/5ml 92.7mg/5ml 77.25%

Limits:- 90.0% to 110.0% Does not comply with USP 32.

Conclusion:- The sample is of “Substandard” quality on the basis of assay.

Minutes for 254th Registration Board Meeting 408

Names of the following persons of the firm have been furnished by the FID along with its report. The firm has violated the Section 23(1)(a)(v) of the Drugs Act 1976.

i. Baxter Pharmaceuticals Karachi ii. Mr. Mr. Sohail Talib, (Chairman), iii. Miss Shabana Nafees (Production Manager) iv. Mr. Reazul Haq (Quality Control Manager)

As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Baxterol Suspension, (Paracetamol) Batch No.BXT014 By M/s Baxter Pharmaceuticals, Karachi.

Case No.10 Manufacture & Sale of Substandard Drug-Netrozol Suspension Batch No.NZ.10A By M/S Standard Drug Company, Hyderabad.

The sample of Netrozol Suspension Batch No. NZ.10-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s vide test report No. R.KQ.41/2015 dated 03rd February 2015. The result of CDL on the basis of which sample under reference has been declared sub-standard as the basis of assay are reproduced as under:-

Assay for Determined amount/5ml Statedamount/5ml Percentage

Metronidazole 133.1469mg 200.0mg 66.57%

Limits:- 95.0% to 105.0% Does Not Comply.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide their test report 010-MNHRS/2015 dated 29th May 2015 are reproduced as under:-.

Assay for Stated Found Limits Percentage

Metronidazole 200mg/5ml 140mg/5ml 95-105% 70.0% Minutes for 254th Registration Board Meeting 409

Does not comply with BP-2011 Conclusion:- The sample is of “Substandard” quality on the basis tests performed.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Netrozol Suspension Batch No.NZ.10A By M/S Standard Drug Company, Hyderabad.

Case No.11 Manufacture & Sale of Substandard Drug-Netrozol Suspension Batch No.NZ.08A By M/S Standard Drug Company, Hyderabad.

The sample of Netrozol Suspension Batch No. NZ.08-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s vide test report No. R.KQ.44/2015 dated 03rd February 2015. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Assay for Determined amount/5ml Statedamount/5ml Percentage

Metronidazole 176.7244mg 200.0mg 88.38% Limits:- 95.0% to 105.0% Does Not Comply.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.

Minutes for 254th Registration Board Meeting 410

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide their test report 011-MNHRS/2015 dated 29th May 2015 are reproduce as under.

Assay for Stated Found Limits Percentage

Metronidazole 200mg/5ml 169.408mg/5ml 95-105% 84.704%

Does not comply with BP-2011 Conclusion:- The sample is of “Sub-Standard” quality on the basis tests performed.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge) As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Netrozol Suspension Batch No.NZ. 08A By M/S Standard Drug Company, Hyderabad.

Case No.12 Manufacture & Sale of Substandard Drug-Staifaminc Suspension (Mefenamic Acid) Batch No.SF.07-A By M/S Standard Drug Company, Hyderabad

The sample of Staifaminc Suspension Batch No. SF.07-A.Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard on the basis of assay vide CDL’s test report No. No. R.KQ.37/2015 dated 06th February 2015 by Federal Government Analyst, CDL, Karachi.

The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Minutes for 254th Registration Board Meeting 411

Assay for Determined amount/5ml Statedamount/5ml Percentage

Mefenamic Acid 21.69mg 50.0mg 43.38%

Limits:- 90.0% to 110.0% Does Not Comply.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard on the basis of assay vide their test report 08-MNHRS/2015 dated 29th May 2015.

Assay for Determined PH Statedamount/5ml Found Percentage

Mefenamic Acid 5.4 50.0mg 18.742mg/5ml 37.484%

Limits:- 90.0% to 110.0% Does Not Comply.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Staifaminc Suspension (Mefenamic Acid) Batch No.SF.07-A By M/S Standard Drug Company, Hyderabad.

Minutes for 254th Registration Board Meeting 412

Case No.13 Manufacture & Sale of Sub-Standard Drug- Linobex-C Syrup (Multivitamins) Batch No. LC.09-A By M/S Standard Drug Company, Hyderabad.

The sample of Linobex-C Syrup Batch No. LC.09-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st February 2015, was declared Substandard vide CDL’s test report No.R.KQ.36 /2015 dated 12th January 2015 by Federal Government Analyst, CDL, Karachi. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Assay for Determined amount/15ml Statedamount/15ml Percentage

Riboflavin 2.60mg 3.0mg 86.66%

Limits:- 90.0% to 130.0% Does Not Comply.

Pyridoxine HCL 0.996mg 2.0mg 49.8%

Limits:- 90.0% to 130.0% Does Not Comply.

Nicotinamade 21.97mg 23.0mg 95.56%

Limits:- 90.0% to 130.0% Complies

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard on the basis of assay vide their test report 013-MNHSR/2015 dated 29th May 2015.

Assay for Statedamount/15ml Found Limit Percentage

Thiamine HCL 3mg 2.79mg/15ml Not less than 90% 93.05%

Does Not Comply.

Pyridoxine HCL 2mg 1.96mg/15ml Not less than 90% 98.0%

Does Not Comply.

Nicotinamade 23mg 17.09mg/15ml Not less than 90% 74.30%

Does not Comply

Riboflavin 3mg 2.32mg/15ml Not less than 90% 77.40%

Does not comply Minutes for 254th Registration Board Meeting 413

Remarks:- Manufacturer failed to supply his specification for Linobex- C (Vitamin-B complex) Syrup. Therefore, alternative specification (Nabi-Qasim Industries Karachi) was followed for the test and analysis of submitted sample The sample is of “Substandard” quality on the basis of assay.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Linobex-C Syrup (Multivitamins) Batch No. LC.09-A By M/S Standard Drug Company, Hyderabad.

Case No.14 Manufacture & Sale of Sub-Standard Drug-Rheu-K 50mg Tablets Diclofenac Potassium Batch No.RK.01A By M/S Standard Drug Company, Hyderabad.

The sample of Rheu-K 50 mg Tablets Batch No. RK.01A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s test report No. R.KQ.24/2015 dated 09th February. The result of CDL on the basis of which sample under reference has been declared sub-standard The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:- i. Dissolution Test Does Not Comply

ii. Assay for Determined amount/5ml Statedamount/5ml Percentage

Diclofenac Potassium 46.66mg 50.0mg 93.32% Limits:- 90.0% to 110.0% Complies.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also Minutes for 254th Registration Board Meeting 414

declared the sample as Substandard on the basis of dissolution test vide their test report 06- MNHSR/2015 dated 29th May 2015. i. Dissolution Test Does Not Comply ii. Assay for Determined Diclofenac Potassium 70.425%

Limits:- Not less than 75.0% of the labeled amount of Diclofenac potassium dissolved in 60 minutes.

Does not comply with USP-32

Remarks:- 1. Reference of Pharmacopoeia BP. Specification is mentioned. However monograph for Diclofenac potassium Tablets is not available in B.P.2013. Therefore USP-32 followed in this regard.

2. Batch No. on the immediate pack is mentioned as OIA whereas on the outer packing it is printed as RK-01A. Moreover batch No. on some strips are not vivid which is misleading and violation of Drug Act 1976

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows:

i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Rheu-K 50mg Tablets Diclofenac Potassium Batch No.RK.01A By M/S Standard Drug Company, Hyderabad.

Minutes for 254th Registration Board Meeting 415

Case No.15 Manufacture & Sale of Substandard Drug- Rheudic-50 Tablets (Diclofenac Sodium) Batch No.RD.04-A By M/S Standard Drug Company, Hyderabad

The sample of Rheudic-50 Tablets Batch No. RD.04-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s test report No. R.KQ.23/2015 dated 03rd February. The result of CDL on the basis of which sample under reference has been declared sub-standard The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:- i. Disintegration Time Does Not Comply ii. Assay for Determined amount/5ml Statedamount/5ml Percentage

Diclofenac Sodium 39.57mg 50.0mg 79.14%

Limits:- 90.0% to 105.0% Does not comply.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide their test report 017-MNHRS/2015 dated 29th May 2015.

i. Disintegration Time:- Determined:- All the six tablets shows sign of cracks in first 2 hours in 0.1M Hydrochloric Acid

Limits:- No tablets shows sign of disintegration or cracks in first 2 hours in 0.1M Hydrochloric Acid

Dose not comply with BP-2013

Remarks:- The sample is “Misbranded & Substandard” quality on the basis of the tests performed.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

02. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Minutes for 254th Registration Board Meeting 416

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Rheudic-50 Tablets (Diclofenac Sodium) Batch No.RD.04-A By M/S Standard Drug Company, Hyderabad.

Case No.16 Manufacture & Sale of Sub-Standard Drug-Sodamint Tablets Batch No. SM-09-A by M/S Standard Drug Company, Hyderabad.

The sample of Sodamint Tablets Batch No. SM.09-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s test report No.R.KQ.26 /2015 dated 12th March 2015 by Federal Government Analyst, CDL, Karachi. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:- i. Mass Variation Does not Complies ii. Assay for Total Carbonate:-

Determined 243.6mg calculated as NaHCO3 Limits:- 275.0mg to 325.0mg Does Not Comply.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard on the basis of assay vide their test report 018-MNHSR/2015 dated 16th June 2015.

Assay for Stated amount/tablet Found Limit Percentage

Sodium Bicarbonate 3mg 300mg 230.487mg/tablet 90-110% 76.829%

Does Not Comply.

Remarks:- As per label the quantity of sodium bicarbonate is printed as Soda Bicarb.BP 300mg but practically average weight of tablet is 244 mg which is apparently less than the stated amount of Sodium Bicarbonate.

Conclusion:- The sample is “Misbranded & Substandard” quality on the basis of the tests performed.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

Minutes for 254th Registration Board Meeting 417

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge) . As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Sodamint Tablets Batch No.SM-09-A By M/S Standard Drug Company, Hyderabad.

Case No.17 Manufacture & Sale of Sub-Standard Drug – Staiflic Tablets (Folic Acid) Batch No. SF.03-A By M/S Standard Drug Company, Hyderabad.

The sample of Staiflic Tablets Batch No. SF.03-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s vide test report No. R R.KQ.25/2015 dated 23rd February. The result of CDL on the basis of which sample under reference has been declared sub-standard The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Assay for Determined amount/tablet Stated amount/tablet Percentage

Folic Acid 83.749 mg 5.0mg 74.98% Limits:- 90.0% to 110.0% Does not comply.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide their test report 014-MNHRS/2015 dated 29th May 2015.

Assay for Stated Found Limit Percentage

Folic Acid 5mg/tab 3.586mg/tab 90-110% 77.118% Does not comply with BP-2011.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

Minutes for 254th Registration Board Meeting 418

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Staiflic Tablets (Folic Acid) Batch No. SF.03-A By M/S Standard Drug Company, Hyderabad.

Case No.18 Manufacture & Sale of Sub-Standard Drug-Montilu 10 mg Tablets (Mountelukast Sodium) Batch No.B01A By M/S Standard Drug Company, Hyderabad.

The sample of Montilu 10mg Tablets Batch No. B01A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s vide test report No. R.KQ.28/2015 dated 09th February 2015. The result of CDL on the basis of which sample under reference has been declared sub-standard

Assay for Determined amount/tablet Stated amount/tablet Percentage

Mountelukast 5.908mg 10.0mg 59.08%

Limits:- 90.0% to 110.0% Does not comply.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard on the basis of assay vide their test report 017-MNHRS/2015 dated 29th May 2015.

Assay for Stated amount/tablet Found Percentage

Mountelukast Sodium 10mg 5.3149mg/tab 53.419% Limits:- 90.0% to 110.0% Does not comply.

Minutes for 254th Registration Board Meeting 419

Remarks:- Manufacturer specification was not available for the test and analysis of Montelukast therefore alternate speciation (MERCK Private Limited) The sample is of “Sub-Standard” quality on the basis of the tests performed.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Montilu 10 mg Tablets (Mountelukast Sodium) Batch No.B01A By M/S Standard Drug Company, Hyderabad.

Case No.19 Manufacture & Sale of Sub-Standard Drug-Stabru Suspension Ibuprofen Batch No.SB.22A by M/S Standard Drug Company, Hyderabad.

The sample of Stabru Suspension Batch No. SB.22A.Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s test report No. R.KQ.40/2015 dated 06th February 2015 by Federal Government Analyst, CDL, Karachi. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Assay for Determined amount/5ml Statedamount/5ml Percentage

Ibuprofen 34.61mg 100.0mg 34.61%

Limits:- 95.0% to 105.0% Does Not Comply. Remarks:- The sample is of “Substandard” quality under the Drug Act 1976.

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide on the basis of assay their test report 09-MNHSR/2015 dated 29th May 2015.

Minutes for 254th Registration Board Meeting 420

Assay for Stated amount/5tablet Found Percentage

Ibuprofen 100mg 32.43mg/5ml 32.43% Limits: 95-105%

Conclusion:- The sample is of “Sub-Standard” quality on the basis of the tests performed.

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

. As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Stabru Suspension Ibuprofen Batch No.SB.22A By M/S Standard Drug Company, Hyderabad.

Case No.20 Manufacture & Sale of Sub-Standard Drug- Stamelox 15 mg Tablets (Meloxicam) Batch No. SA01-A By M/S Standard Drug Company Hyderabad.

The sample of Stamelox 15mg Tablets Batch No. SA01-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard CDL’s vide test report No. R.KQ.18/2015 dated 12th February 2015. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Assay for Determined amount/tablet Statedamount/5ml Percentage

Meloxicam 12.813mg 15.0mg 85.42%

Limits:- 90.0% to 110.0% Does Not Comply.

Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.

Minutes for 254th Registration Board Meeting 421

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard on the basis of assay vide their test report 012-MNHRS/2015 dated 29th May 2015.

Dissolution:- Determined 63.22%

Limits:- Not less than 70% of Meloxicam dissolved in 30 minutes.

Does not comply with BP-32

Conclusion:- The sample is of “Subsandard” quality on the basis of the tests performed

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Stamelox 15 mg Tablets (Meloxicam) Batch No. SA01-A By M/S Standard Drug Company Hyderabad.

Case No.21 Manufacture & Sale of Sub-Standard Drug- Standlo 500mg Tablets (Levofloxicine) Batch No.SO-03-A By M/S Standard Drug Company, Hyderabad

The sample of Standlo 500mg Tablets Batch No. SO-03-A Manufactured by M/s Standard Drug Company, Hyderabad .drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, was declared Substandard vide CDL’s test report No. R.KQ.21/2015 dated 26th February 2015 by Federal Government Analyst, CDL, Karachi. The result of CDL on the basis of which sample under reference has been declared sub-standard are reproduced as under:-

Dissolution Test. Does not comply. (Detail is as under)

Tablet No. %age Minutes for 254th Registration Board Meeting 422

01. 22.833 02. 32.735 03. 24.652 04 19.60 05. 24.470 06 21.418

Limits:- Not less than 80.0% Does not comply with USP 37.

Remarks:- The sample is of “Substandard” quality under the Drug Act 1976

On explanation letter issued by the FID, the firm challenged the CDL report and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the sample as Substandard vide their test report 015-MNHRS/2015 dated 29th May 2015. Dissolution:- Determined 27.78% Limits:- Not less than 80% of the label amount

Remarks:- i. Batch No. printed on the outer carton is SO-03-A whereas on the immediate packing it is mentioned as B3 which is contradictory statement given by the manufacturer.

ii. Manufacture fail to supply the specification for Standlo (Levofloxacin) 500mg tablets Moreover the Levofloxacin Tablets were neither available in BP-2013 nor in USP-32 Therefore alternative specification (Getz Pharma) followed for the test and analysis of provided sample.

Conclusion:- The sample is of “Substandard” quality on the basis of the tests performed

The names of the following persons of the firm have been furnished and firm violated the section 23(1)(a)(v) of the Drug Act 1976 by the FID along with its report:-

i. M/s Standard Drug Company, Hyderabad ii. Mr. Imtiaz Ahmed, (M.D), iii. Mrs. Qurat-ul-Ain (Production Incharge), iv. Mr. Haider Zaidi (Quality Control Incharge)

As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.

Decision: Registration Board decided as follows: i. To give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. To get the recalled status and report from the area FID for Standlo 500mg Tablets (Levofloxicine) Batch No.SO-03-A By M/S Standard Drug Company, Hyderabad. Minutes for 254th Registration Board Meeting 423

Item No. IV: Cases referred by Pharmaceutical Evaluation & Registration Division.

Registration-I

Case No.01. Registration of Clarinase Repetabs (Reg. No.017805)” from M/s. Schering- Plough Pakistan (Pvt.) Limited, Karachi to M/s. Bayer Pakistan (Private) Limited, Karachi.

M/s. Bayer Pakistan (Private) Limited, Karachi have requested for transfer of registration of their imported drug “Clarinase Repetabs (Reg. No.017805)” from M/s. Schering-Plough Pakistan (Pvt.) Limited, Karachi to their name due to an International Acquisition of the Consumer Care Business and assets related thereto from Merck & Co., Inc., and its subsidiaries including Schering Plough by the Bayer AG Group. M/s. Bayer Pakistan (Private) Limited, Karachi have deposited the required fee Rs.100,000/- and submitted following supporting documents:-

i) Copy of registration letter. ii) Copy of transfer of registration letter in the name of M/s. ICI Pharmaceuticals, Karachi. iii) Copy of transfer of registration letter in the name of M/s. Schering-Plough Pakistan (Pvt.) Limited, Islamabad.. iv) Copy of last renewal status. v) NOC for RF clearance.. vi) Termination letter from manufacturer abroad for previous importer.. vii). Authority letter / sole agent letter from manufacturer abroad.. viii). NOC from existing registration holder for transfer of registration. ix) Application on Form 5-A along with supporting documents.

The firm was advised to provided following information / documents as per approved SOP:- i) Latest renewal status of the product. ii) NOC for CRF. In response, M/s. Bayer Pakistan (Private) Limited, Karachi have submitted Latest renewal status of the product and NOC for CRF Decision: Registration Board decided as follows:

 Cancellation of registrations of Clarinase Repetabs, Reg. No.017805 from the name of M/s. Schering-Plough Pakistan (Pvt.) Limited, Karachi. Minutes for 254th Registration Board Meeting 424

 Registration of Clarinase Repetabs, Reg. No.017805 in the name of M/s. Bayer Pakistan (Private) Limited, Karachi. The Registration Board authorized its Chairman for issuance of registration letters after comments / fixation of MRP by Cost & Pricing Division.

Case No.02. Deferred drugs for recommendations of Expert Committee on Medical Devices.

The Drug Registration Board in its 245th meeting held on 29-30th September, 2014 deferred under mentioned drugs for recommendations of Expert Committee on Medical Devices. The recommendation of Expert Committee on Medical Devices are mentioned against each drug below:-.

S.# Name of Name of Drug (s) Demanded Shelf Recommendations Manufacturer / Composition & Price & Pack Life of ECMD Importer. Therapeutic Size. Group. 1. M/s. Hashir Bio Shield First Aid As per PRC 05 years The Committee Surgical Services Bandages Recommended the (Pvt) Ltd. 76X19mm product for Peshawar- 76X19mm consideration of Pakistan. / 56x19mm registration section M/s. Zhejiang 40x10mm on the basis of Bangli Medical DIA22mm samples. Products Co. Ltd., 76X19mm Yuegui South 56x19mm Road City West 40x10mm New District DIA22mm Yongkang City, 72X19mm Zhejiang Province, 72X19mm China. 72X19mm 56x19mm 40x10mm Dia22mm 76x19mm 76x19mm 38x38mm 76X19mm 76X19mm 72x19mm 72x19mm

Minutes for 254th Registration Board Meeting 425

70x18mm (Disposable Bandages).

2. M/s. Hashir Bio Shield Medicated As per PRC 05 years The Committee Surgical Services Plaster (Zinc Oxide). Recommended the (Pvt) Ltd. 1.25cm x 5m product for Peshawar- 2.5cm x 5m consideration of Pakistan. / 5cm x 5m registration section M/s. Zhejiang 7.5cm x 5m on the basis of Bangli Medical 10cm x 5m samples. Products Co. Ltd., 1.25cm x 10m Yuegui South 2.5cm x 10m Road City West 5cm x 10m New District 7.5cm x 10m Yongkang City, 10cm x 10m Zhejiang Province, (Disposable China. Medical). 3. M/s. Hashir Bio Shield Surgical As per PRC 05 years The Committee Surgical Services Tape (Non Woven). Recommended the (Pvt) Ltd. All sizes product for Peshawar- 1.25cmx5m consideration of Pakistan. / 2.5cmx5m registration section M/s. Zhejiang 5cmx5m on the basis of Bangli Medical 7.5cmx5m samples. Products Co. Ltd., 10cmx5m Yuegui South 1.25cmx10m Road City West 2.5cmx10m New District 5cmx10m Yongkang City, 7.5cmx10m Zhejiang Province, 10cmx10m China. (Disposable Medical Devices/Surgical Tape). 4. M/s. Hashir Bio Shield Surgical As per PRC 05 years The Committee Surgical Services Tape PE Recommended the (Pvt) Ltd. 1.25cmx5m product for Peshawar- 2.5cmx5m consideration of Pakistan. / 5cmx5m registration section M/s. Zhejiang 7.5cmx5m on the basis of Bangli Medical 10cmx5m samples. Products Co. Ltd., 1.25cmx10m Yuegui South 2.5cmx10m Road City West 5cmx10m New District 7.5cmx10m Yongkang City, 10cmx10m Minutes for 254th Registration Board Meeting 426

Zhejiang Province, (Surgical Tape). China. 5. M/s. Hashir Biopore Surgical As per PRC 05 years The Committee Surgical Services Tape Recommended the (Pvt) Ltd. 5cm x 1000cm product for Peshawar- 10cm x 1000cm consideration of Pakistan. / 15cm x 1000cm registration section M/s. Yafho Bio- 20cm x 1000cm on the basis of technology Co. (Fix Roll) samples. Ltd., Plant, Hengsheng Ind. Zone, West Yicun Ind. Road, Luopu Street, Panyu District, Guangzhou, China.

Decision:- Registration Board approved registration of above products subject to inspection of manufacturer abroad as per Import Policy for Finished Drugs, verification of storage facilities and price fixation / calculation etc.

Case No.03. Change of Manufacturer/Manufacturing Site.

M/s. RG Pharmaceutica (Pvt.) Ltd, Karachi have requested to approve the change of manufacturer / manufacturing site of their registered product “Venofer I.V. Injection (Iron sucrose) (Reg. No.023654)” from M/s. Vifor (International) Inc., Switerland to M/s. Takeda Austria GmbH., St. Peter-Strasse 25, 4020 Linz, Austria. M/s. RG Pharmaceutica (Pvt.) Ltd, Karachi have deposited the of fee Rs.100, 000/- and submitted following supporting documents:- i) Copy of initial registration letter. ii) Copy of change of the company name. iii) Copies of last renewal acknowledgement. iv) Original Certificate of Pharmaceutical Product attested by Pakistani Embassy. v) Application on Form-5 (A).

Decision:- Registration Board approved the request of change of manufacturing site of Venofer I.V. Injection (Iron sucrose) (Reg. No.023654)” from M/s. Vifor (International) Inc., Switerland to M/s. Takeda Austria GmbH., St. Peter-Strasse 25, 4020 Linz, Austria subject to inspection of manufacturer abroad as per Import Policy for Finished Drugs.

Minutes for 254th Registration Board Meeting 427

Case No.04. Registration of Veterinary Drugs for export purpose.

M/s. Star Laboratories (Pvt.) Ltd, Lahore has applied for registration of the following veterinary drugs for export: -

S # Name of Drug (s)/Composition. Pack Size. 1. Prazistar Tablet. As per importing Each tablet contains:- country Praziquantel (BP) ...... 20mg. requirement. Pyrantel Pamoate (BP) ....230mg. 2. Prazistar Plus Tablet. As per importing Each tablet contains:- country Praziquantel (BP) ...... 50mg. requirement. Pyrantel Pamoate (BP) ...... 144mg. Fenbantel (BP) ...... 150mg. 3. Carprofen Tablet. As per importing Each tablet contains:- country Carprofen I.H.S) ...... 50mg. requirement. 4. Tilmisin Oral Solution. As per importing Each ml contains:- country Tilmicosin (as sulphate) (USP) 250mg. requirement. 5. Levozan Plus DS Suspension. As per importing Each 100ml contains:- country Levamisol HCl ...... 3gm. requirement. Oxyclozanide...... 6gm. Cobalt Sulphate ...... 764mg. 6. Diclavet Oral Solution. As per importing Each 100ml contains:- country Dicalzuril (BP) ...... 1gm. requirement.

M/s. Star Laboratories (Pvt.) Ltd, Lahore have deposited required fee Rs.20,000 x 6= Rs.120,000/- and submitted the following supporting documents:- i) Copy of Drug Manufacturing Licence. ii) Copy of acknowledgement of receipt of application for renewal of Drug Manufacturing Licence No.000130) (Formulation). iii) Copy of NOC for CRF. iv) Applications on Form-5.

The firm was advised to provided following information / documents as per approved SOP:- i) Copy of approved sections from Central Licensing Board. ii) An undertaking that applied registration is exclusively for export purpose and will not be sold in Pakistan. Minutes for 254th Registration Board Meeting 428

iii) If formulation / product is not registered in Pakistan, then export order from importing country. In response, M/s. Star Laboratories (Pvt.) Ltd, Lahore has provided are as under:- i) The firm has provided copy of inspection report dated 13-06-2011 for renewal of DML, as evidence of availability of the Section ii) Undertaking provided that applied registrations are exclusively for export purpose and will not be sold in Pakistan. iii) Photocopy of export order from importing country.

However the firm has not been able to provide appropriate evidence of Mee-to status of above product.

Decision: Registration Board was apprised that in 241st and 246th meeting it was decided that registration of new drugs / formulations for export purpose will be granted if applicant provide import order of any country. Registration Board deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. Accordingly, above case was decided as follows:  Approved grant of registrations for export purpose for items at S.No.2. Firm will deposit remaining fee for grant of registration and Chairman, Registratiuon Board will then permit isuuance of export registration letter. Manufacturer will comply following conditions before export of drug: a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product. c. Deferred items at S.No.1, 3-6 for deliberation in forthcoming meeting as decided above.

Case No.05. Registration of drugs under the Drugs Act, 1976. Registration Board in its 236th meeting held on 20th November, 2012 approved the registration of following veterinary drugs of M/s. Nawan Laboratories (Pvt.) Ltd; Karachi for local manufacturing as mentioned in column-I. The firm has now requested to correct the formulation as mentioned in column-II, it was mentioned incorrect inadvertently while typing the agenda and minutes of the Registration Board:- S. I II No. Name of Drug(s)/Composition Name of Drug(s)/Composition applied

Minutes for 254th Registration Board Meeting 429

approved by Registration Board. by the firm/correct. 1. Colibac-SP 160 Powder Colibac-SP 160 Powder Each Kg powder contains:- Each Kg powder contains:- Penicillin Procaine.B.P…….....1.6 Kg Procaine Penicillin B.P…………16gm. Streptomycin Sulphtae B.P…...4.0 Kg Streptomycin Sulphtae B.P……..40gm. Zinc Bacitracin 10% BP Vet..10.0 Kg Zinc Bacitracin 10% B.P. Vet…100gm. Colistin Sulphate.BP………….0.4Kg Colistin Sulphate.B.P………….80MIU

2. PSB-Excel Powder. PSB-Excel Powder. Each Kg powder contains:- Each kg powder contains:- Pencillin Procaine BP………..12.0Kg Procaine Penicillin B.P…….....12gm. Streptomycin Sulphate BP…...36.0Kg Streptomycin Sulphate B.P……36gm. Zinc Bacitracin10% BP……...52.0Kg Zinc Bacitracin 10% B.P Vet…52gm. Neomycin Sulphate BP………10.0Kg Neomycin Sulphate B.P………10gm.

Licensing Directorate was requested to give opinion that the products containing Penicillin derivative along-with other veterinary API as mentioned above, can be manufactured in human section or otherwise. In reply Licensing Division has communicated that sub section 5.2 of Schedule-B of Drug (Licensing, Registering & Advertising) Rules, 1976 which, inter alia, specify that Veterinary products containing ingredients similar to those used for human health and of the same quality can be manufactured in the same premises used for manufacture of pharmaceuticals. The firm has provided copy of inspection report dated 26-02-2011, wherein the panel has verified that the firm possesses the facilities for manufacturing penicillin Non-Sterile Dry Powder Syrup for human preparations. However, the issue that whether the formulation containing non penicillin antibiotics / antibacterial i.e Streptomycin Sulphate, Zinc Bacitracin, Colistin Sulphate etc in combination with penicillin products can be permitted in human Penicillin Dry Powder/ Syrup section, is yet to be clarified. Decision:- Registration Board deferred the case for detail deliberation in the next meeting.

Case No.06. Change of exporter. The following firms have requested to approve the change of exporter of their below mentioned registered imported drugs from previous exporters to M/s. Ninhua Group Co. Ltd. 21, Jiangxia Street, Ningbo 315000 P.R. China. The firms have clarified that previous exporters

Minutes for 254th Registration Board Meeting 430

were having credit problems in exporting the pharmaceutical finished products to Pakistan, therefore, the manufacturers of these drugs have amicably agreed that their pharmaceutical finished products will be exported through M/s. Ninhua Group Co. Ltd. 21, Jiangxia Street, Ningbo 315000 P.R. China. There is no change in manufacturing site.

I. M/s. Mehran International, Karachi. S.No. Regn.No. Name of Product Name of Applicant/ Name of New Existing Manufacturer, Exporter Exporter 1. 043061 Water for injection M/s. Mehran International, M/s. Ninhua 5ml Karachi. / Group Co. Ltd. Manufacturer by 21, Jiangxia M/s. Shanxi Shuguang Street, Ningbo Pharmaceutical Co. Ltd. 315000 China. P.R.China. Exporter not mentioned. 2. 021032 Atropine Injection M/s. Mehran International, -do- 1mg/ml Karachi. / Manufacturer by M/s. Shanxi Shuguang Pharmaceutical Co. Ltd. China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 3. 022629 Metoclopromide -do- -do- Injection 10mg/2ml 4. 017430 Dexamethason -do- -do- Injection 4mg/ml 5. 016824 Chloroquine -do- -do- Injection 5ml 6. 019534 Fosfomycin -do- -do- Injection 1gm

7. 017429 Gentamycin -do- -do- Injection 80mg/2ml 8. 047696 Dimenhydrinate -do- -do- Injection 50mg/1ml 9. 047697 Omiperazole -do- -do- Injection 40mg. 10. 022633 Sinobiotic Injection -do- -do- 0.5gm 11. 022634 Sinobiotic Injection -do- -do- Minutes for 254th Registration Board Meeting 431

1gm 12. 022631 Benzyl Penicillin -do- -do- for Injection 0.5mega 13. 021196 Vitamin D3 -do- -do- Injection 600,000 I.U./ml 14. 019535 Fosfomycin M/s. Mehran International, -do- Capsules 500mg. Karachi./ Manufactured by M/s.Ningbo Shuangwei Pharmaceutical Co.Ltd. P.R.China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 15. 022628 Doxycycline -do- -do- Capsules 100mg 16. 019536 Fosfomycin Syrup -do- -do- 250mg/5ml 17. 045738 Ofloxacin Tablets -do- -do- 200mg. 18. 045739 Ciprofloxacin -do- -do- Tablets 250mg. 19. 045740 Ciprofloxacin -do- -do- Tablets 500mg.

20. 045737 Ciprofloxacin M/s. Mehran International, -do- Injection Karachi./ 200mg/100ml Manufactured by M/s. Wuhan Grand Pharmaceutical Group Co. Ltd. P.R. China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China.

21. 014021 Mannitol Solution M/s. Mehran International, -do- 20% Injection Karachi. / 500ml Manufactured by M/s. Zhejiang Chimin Pharmaceutical Co.Ltd. P.R. China. Exported by:- Minutes for 254th Registration Board Meeting 432

M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 22. 052272 Normalsaline-9 -do- -do- Injection 0.9g/100ml 23. 021031 Dextrose 25% M/s. Mehran International, -do- Injection Karachi. / Manufactured by M/s. Zhejiang Tianrui Pharmaceutical Co. Ltd. P.R.China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 24. 072555 Water for Injection -do- -do- 20ml 25. 072556 Normalsaline 0.9% -do- -do- Injection 20ml 26. 047685 Cefotaxime Sodium M/s. Mehran International, -do- Injection 250mg Karachi. / Manufactured by M/s. Beijing Hengsheng Pharmaceutical Co. Ltd. P.R.China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 27. 047686 Cefotaxime Sodium -do- -do- Injection 500mg 28. 047687 Cefotaxime Sodium -do- -do- Injection 1gm 29. 045741 Ceftriaxone for -do- -do- Injection 250mg. I.V. 30. 045742 Ceftriaxone for -do- -do- Injection 500mg. I.V. 31. 045743 Ceftriaxone for -do- -do- Injection 1gm I.V. 32. 049613 Amoxycillin l.A. M/s. Mehran International, -do- Injection 15% Karachi. / Manufactured by M/s. Jiangxi Jinkonka Minutes for 254th Registration Board Meeting 433

Biochemical Pharmaceutical Co. Ltd. P.R.China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 33. 022179 Gentamycin 10% -do- -do- Injection 34. 049571 Colistin Sulphate M/s. Mehran International, -do- Injection.30,000,000 Karachi. / I.U. Manufactured by M/s. Jiangxi Jinkonka Biochemical Pharmaceutical Co. Ltd. P.R.China. Exported by:- M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 35. 039957 Tylosin 20% -do- -do- Injection 36. 021425 Chloramphenicol -do- -do- 20% Injection 37. 049576 Vitamin AD3 -do- -do- Injection 38. 049577 Sodium Selenite & -do- -do- Vitamin E Injection 39. 019045 Enroquine Forte -do- -do- Injection 40. 049572 Ceftiofur Sodium -do- -do- Injection 0.5gm 41. 013731 Oxytetracycline -do- -do- 50mg/ml Injection 42. 019054 Ivojec 1% Injection -do- -do-

II. M/s. Imran & Company, Karachi. S.No. Regn.No. Name of Product Name of Applicant/ Name of New Existing Exporter Manufacturer, Exporter 1. 013458 Oxytetracycline M/s. Imran & M/s. Ninhua Capsules 250mg Company, Karachi. / Group Co. Ltd. Manufactured by 21, Jiangxia M/s. Ningbo Shuangwei Street, Ningbo Pharmaceutical Co. Ltd. 315000 China. P.R.China. Minutes for 254th Registration Board Meeting 434

Exporter by M/s. Ningbo Tisun Medic Biochemic Co. Ltd., China. 2. 014018 Amoxicillin Injection M/s. Imran & -do- 500mg Company, Karachi. / Manufactured by M/s. Yanzhou Xier Kangtai Pharmaceutical Co. Ltd. China. Exporter by M/s. Ningbo Tisun Medic Biochemic Co. Ltd., China.

M/s. Pak China International, Karachi. S.No. Regn.No. Name of Product Name of Applicant/ Name of New Existing Exporter Manufacturer, Exporter. 1. 013267 Metronidazole M/s. Pak China M/s. Ninhua Injection 100ml International, Karachi. / Group Co. Ltd. M/s. Furen 21, Jiangxia Pharmaceutical Group Street, Ningbo Co. Ltd. China. 315000 P.R. Exported by M/s. China. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China. 2. 012359 Kanamycin Injection M/s. Pak China -do- 1gm International, Karachi. / M/s. Shanxi Shuguang Pharmaceutical Co. Ltd. China. Exported by M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China.

3. 012360 Streptomycin -do- -do- Injection 1gm 4. 078146 Sodium Ringer M/s. Pak China -do- Lactate Injection International, Karachi. / Manufactured by M/s. Zheijing Chimin Minutes for 254th Registration Board Meeting 435

Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan, Zhejiang, P.R. China.

5. 012168 Ampicillin Injection M/s. Pak China -do- 500mg International, Karachi. / Manufactured by M/s. Yanzhou Xier Kangtai Pharmaceutical Co. Ltd. China. Exporter by M/s. Ningbo Tisun Medic Biochemic Co. Ltd., China.

III. M/s. Shaheen Agency, Karachi.

S.No. Regn.No. Name of Product Name of Applicant/ Name of New Existing Exporter Manufacturer, Exporter 1. 021030 Procain Penicillin for M/s. Shaheen Agency, M/s. Ninhua Injection 0.4 Mega Karachi./ Group Co. Ltd. Manufactured by 21, Jiangxia M/s. Shanxi Shuguang Street, Ningbo Pharmaceutical Co. Ltd. 315000 China. P.R.China. Exported by M/s. Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China.

2. 017434 Lincomycin Injection -do- -do- 600mg/2ml 3. 021029 Diclofenic Injection -do- -do- 75mg/3ml 4. 017433 Vitamin K Injection M/s. Shaheen Agency, -do- Karachi./ Manufactured by M/s. Furen Pharmaceutical Group Co. Ltd. China. Exported by M/s.

Minutes for 254th Registration Board Meeting 436

Ningbo Tisun Medic Biochemic Co. Ltd., Ningbo P.R. of China.

The firms have submitted following documents:- (i) Deposited fee Rs. 5000 x 42 = Rs.210, 000/-, Rs 5000 x 2 = Rs.10, 000/-, Rs. 5000 x 5 = Rs.25, 000/-, 5000 x 4 = Rs.20, 000/- (ii) No objection certificate from manufacturer for change of exporter in Pakistan to Ninhua Group Co.Ltd.21, Jiangxia Street, Ningbo 315000 P.R.China duly attested by China Council for the Promotion of International Trade China Chamber of International Commerce. (iii) Sole Agency Agreement between exporter M/s.Ninhua Group Co.Ltd. Ningbo China, Manufacturer and importing Firms. (iv) Credential of exporter M/s. Ninhua Group Co.Ltd. Ningbo. (v) Copies of registration letters. (vi) Renewal status of all the applied products.

Decision:- Registration Board approved the exporter as M/s. Ninhua Group Co. Ltd. 21, Jiangxia Street, Ningbo 315000 P.R. China for the above products with same terms and conditions.

Case No.07. Request of M/s Amgomed, Islambad for change of manufacturing site.

Registration Board in its 236th meeting approved the registration of following product of M/s. Amgomed, Islamabad manufactured by M/s. Medac, Gesellschaft fur klinische Spezialpraparate mbH, Theaterstrasse 6, D-22880, Wedel Germany, subject to inspection of manufacturer abroad, verification of storage facilities and price/calculation etc as per policy:- S. No. Name of Drug(s) Shelf Life Fee deposited Price approved by the Drug Pricing Committee 1. Oxaliplatin Medac 150mg 04 years Rs. 1,00,000/- Rs. 28,500.00/per vial Injection Each vial contains:- Oxaliplatin…………150mg (Anticancer)

The firm was subsequently asked to provide original CoPP of “Oxliplatin Medac 150mg Injection”. Meanwhile, the firm has submitted revised application with changed manufacturing site abroad as per following details.

Minutes for 254th Registration Board Meeting 437

i) Product Licensed Holder (name & address) also responsible for Packaging/Labeling. M/s. medac Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstrasse 3 20354 Hamburg / Germany. ii) Manufacturer: M/s. Oncotec Pharma Produktion GmbH Am Pharmapark 06861 Dessau- Roβlau / Germany.

The firm has deposited the requisite fee of Rs. 1,00,000/- and submitted following supporting documents:- i) Application on Form-5A ii) Letter of Marketing Authorization. iii) Legalized CoPP attested by Pakistan Embassy. iv) Site Master File. v) Credential of Manufacturer. vi) Copy of Drug Sale License.

Decision: - Registration Board decided to approve the change of manufacturing site and other relevant information in accordance with CoPP as per following details:- Product Licensed Holder (also responsible for Packaging/Labeling): M/s. medac Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstrasse 3 20354 Hamburg / Germany. Manufacturer: M/s. Oncotec Pharma Produktion GmbH Am Pharmapark 06861 Dessau-Roβlau / Germany.

Case No.08. Registration from Schering Plough Pakistan (Pvt.) Ltd to M/s. OBS Pakistan (Pvt) Ltd. Kareachi. M/s. OBS Pakistan (Pvt) Limited, Karachi have requested for transfer of registration of the following products of Schering Plough Pakistan (Pvt.) Ltd. in their name as later has been merged with “OBS Pakistan (Pvt) Ltd. Karachi.

S. No. Reg. No. Name of Drug (s). Name of Manufacturer.

1. 063937 Rinelon Aqueous Nasal M/s. Schering-Plough Labo Spray. N.V., Heist-op-den-Berg, Each metered dose spray Belgium. contains: - Mometasone Furoate 50mcg. 2. 031369 Ezetrol 10mg Tablets. Manufactured by:- Minutes for 254th Registration Board Meeting 438

Each tablet contains:- M/s. Schering-Plough Products, Ezetimibe Micronized L.L.C Pridco Industrial Park, 10mg. State Road # 183, Las Piedras, Puerto Rico. Supplied by:- M/s. Merck Sharp & Dhome, Haarlem, Holland. 3. 033145 Integrilin 0.75mg Manufactured by:- Injection. M/s. Patheon Italia S.P.A, Each ml contains:- Ferentino, Italy. Integrilin 0.75mg. Release Site:- M/s. Schering-Plough Labo N.V., Belgium. 033146 Integrilin 2mg/ml -do- Injection. Each ml contains:- Integrilin 2.0mg.

M/s. OBS Pakistan (Pvt) Limited, Karachi have deposited required fee Rs.100000x4=400000/- and submitted the following documents:- i) Applications on Form-5 (A). ii) Copies of registration letters and last renewal. iii) Authority letter from manufacturer. iv) NOC from existing registration holder for transfer of registration. v) Copy of the merger documents between M/s. OBS Pakistan (Pvt) Limited & M/s. Schering Plough Pakistan (Pvt.) Ltd. vi) Copy of NOC for CRF.

M/s. OBS Pakistan (Pvt) Limited, Karachi was advised to submit the following documents / information:- i) Renewal status of Rinelon Aqueous Nasal Spray. ii) Original authority letter from manufacturer and NOC. iii) Latest CRF Certificate. In response M/s. OBS Pakistan (Pvt) Limited, Karachi have submitted the following documents:- 1. Renewal status of Rinelon Aqueous Nasal Spray. 2. Notarized copy of authority letter from manufacturer & NOC. 3. Latest CRF Certificate.

Minutes for 254th Registration Board Meeting 439

The firm has further submitted that original authority letter from manufacturer & NOC already have been submitted to Biological Section with transfer application of Peg-Intron 50mg. Decision: Registration Board decided as follows:

 Cancellation of registrations of products at S.No.1, 2 and 3 from the name of M/s. Schering-Plough Pakistan (Pvt.) Limited, Karachi.  Registration of products at S.No.1, 2 and 3 in the name of M/s. OBS Pakistan (Pvt) Limited, Karachi. The Registration Board authorized its Chairman for issuance of registration letters after comments / fixation of MRP by Cost & Pricing Division.

Case No.09. Change of manufacturing site/source.

M/s. Ali Gohar & Company (Private) Limited, Karachi have requested to approve the change of manufacturing site/source of their following registered imported drugs from M/s. Alcon, Belgium to M/s. Alcon Singapore Manufacturing PTE. Ltd, 19 Tuas South Avenue 14 Singapore 637313:-

S. No. Reg. No. Name of Product (s). 1. 028401 Travatan Sterile Ophthalmic Solution. 2. 008249 Tobrex Ophthalmic Sterile Solution. 3. 023129 Tears Naturale II Eye Drops.

The firm have deposited required fee Rs.100,000x3=Rs.300,000/- and submitted following supporting documents:- i) Original Certificates of Pharmaceutical Products legalized by Pakistan Embassy. ii) Original GMP Certificate legalized by Pakistan Embassy. iii) Applications on Form 5-A. iv) Copy of Site Mister File. v) Copies of initial registration letters. vi) Copy of change of source of import of Tobrex & Travatan. vii) Copies of latest renewal acknowledgements.

As per renewal record submitted by the firm the renewal of Travatan Sterile Ophthalmic Solution and Tobrex Ophthalmic Sterile Solution is submitted after due date with double fee. Decision:- The Registration Board approved the change of manufacturing site/source of above imported drugs from M/s. Alcon, Belgium to M/s. Alcon Singapore Manufacturing Minutes for 254th Registration Board Meeting 440

PTE. Ltd, 19 Tuas South Avenue 14 Singapore 637313 on same and conditions subject to inspection of manufacturer abroad as per Import Policy for Finihed Drugs. In case of Travatan Sterile Ophthalmic Solution & Tobrex Ophthalmic Sterile Solution, the formal orders of the Registration Board regarding validity of renewal of registration are to be required before issuance of the permission.

Case No. 10. Request by Ms. BSN Medical (Pvt) Ltd, Karachi for change of manufacturing site/source of their registered products..

Registration in its 249th meeting held on 18th -19th May, 2015 discussed the request of M/s. BSN Medical (Pvt) Ltd., Karachi for change of source of manufacturing site of their following registered from M/s. Smith & Nephew Medical Limited, 101 Hassle Road, Hull HU3 2BN, England to M/s. Smith & Nephew Medical (Suzhou) Limited, No.12, Wuxiang Road, Comprehensive Free Zone, West Zone, Suzhou Industrial Park, Jiangsu Province, 215021, China. S. No. Reg. Name of Products. No. 1. 018940 Cica-Care (Adhesive Gel Sheet) Soft, Self Adhesive Semi Occulusive Gel Sheet made from medical grade Silicon reinforced with Silicon membrane baking. 2. 001293 Bactigras (Chlorheixidine Tulle Gras Dressings) An open mesh cotton gauze impregnated with white soft paraffin B.P containing 0.5% micronised Chlorhexidine Acetate B.P.C.

The Board after considering the case directed to ask the firm to clarify that why these products are not on free sale in the country of orgin i.e. China. The firm has now informed that the China site is only the manufacturing and export site for Bactigras & Cica-Care. The site is not responsible for the local marketing of these products in China. The firm has already provided original legalized TGA Certificate attested by the Pakistan Embassy for Bactigras Chlorhexidine Acetate Tulle Gras Dressings & and legalized certificate from Ministry of Japan for Cica-Care Adhesive Gel Sheet and further claimed that that these products are already approved and sold in UK, Canada and other countries.

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The firm have deposited required fee Rs.100, 000x2=200,000/- and submitted following supporting documents:- i) Copies of initial registration letters for Bactigras & Cica-Care & renewal submission.. ii) Legalized Free Sale Certificate for Export for Bactigras and Cica-Care issued by Jiangsu Food and Drug Administration, China. iii) Certificate of Free Sale by TGA Australia for Bactigras and Pharmaceutical & Medical Devices Agency, Japan for Cica-Care as alternate site. iv) BSI Assessment Report. v) Articles of Association. vi) Site Master File. vii) Form-5 (A).

Decision:- Registration Board approved change of manufacturing site of above registered drugs from M/s. Smith & Nephew Medical Limited, 101 Hassle Road, Hull HU3 2BN, England to M/s. Smith & Nephew Medical (Suzhou) Limited, No.12, Wuxiang Road, Comprehensive Free Zone, West Zone, Suzhou Industrial Park, Jiangsu Province, 215021, China as the products are approved for free sale by TGA Australia and BP & MDA Japan.

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Registration-II Case No. 11 Cases of extension in contract manufacturing with change of contract manufacturer

S.No. Applicant Existing Proposed Reg. Name of drug(s) & Date of Category Contract contract contract No. Composition application, permission valid Manufacturer manufacturer Diary No. up till and Registration Board Meeting of previous approval 18) Laderly Bio- Bloom Bio-Labs (Pvt) 025211 Doxy-A 100mg Capsule 29.06.2015 -do- -do- Tech, Karachi Pharmaceutical, Ltd., Islamabad Each capsule contains: 443 Hattar Doxycycline as Rs. 50,000/- hyclate………..100 mg 29.06.2015 19) -do- -do- -do- 025209 Topcef 1gm IV Inj. 29.06.2015 -do- -do- Each vial contains: 446 Ceftriaxone as Rs. 50,000/- sodium…………1gm 29.06.2015 20) -do- -do- -do- 025207 Topcef 250mg IV Inj. 29.06.2015 -do- -do- Each vial contains: 446 Ceftriaxone as Rs. 50,000/- sodium…………250 mg 29.06.2015 21) -do- -do- -do- 025208 Topcef 250mg IM Inj. 29.06.2015 -do- -do- Each vial contains: 445 Ceftriaxone as Rs. 50,000/- sodium…………250 mg 29.06.2015 22) -do- -do- -do- 026639 Azicin 250mg Capsule 29.06.2015 -do- -do- Each capsule contains: 444 Azithromycin ……250 Rs. 50,000/- mg 29.06.2015 23) Delux Chemical Fassgen Pharma Bio-Labs (Pvt) 058468 Somelopime 1000mg 29.06.2015 Import to 30.06.2015 Industries, Hattar Ltd., Islamabad Injection 431 local Meeting 238th Karachi. Each vial contains:- Rs. 50,000/- contract Cefepime as HCl with 29.06.2015 manufactu Minutes for 254th Registration Board Meeting 443

sterile ring l-Arginine …1000mg

24) -do- -do- -do- 058467 Somelopime 500mg 29.06.2015 -do- -do- Injection 429 Each vial contains:- Rs. 50,000/- Cefepime as HCl with 29.06.2015 sterile l-Arginine ………………500mg

25) -do- -do- -do- 058473 Efoparazone 2gm 29.06.2015 -do- -do- Injection 432 Each vial contains:- Rs. 50,000/- Cefoperazone as 29.06.2015 Sodium..1000mg Sulbactam as Sodium…..1000mg

26) -do- -do- -do- 058472 Efoparazone 1gm 29.06.2015 -do- -do- Injection 430 Each vial contains:- Rs. 50,000/- Cefoperazone as 29.06.2015 Sodium..500mg Sulbactam as Sodium…..500mg

Decision: Registration Board approved request of the firm for change in contract manufacturer of above products from previous contract manufacturer to new contract manufacturer (Bio-Labs (Pvt) Ltd., Islamabad) and extended the permission till 30.06.2020 in the light of rule 20 A of Drugs (L,R & A) Rules, 1976.

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Case No. 12: Deferred case

The Registration Board in its 249th meeting deferred following product of M/s Pharmatec for Scrutinization of application as per checklist approved by Registration Board. The decision of the Registration is reproduced in the last column below: Name of Drug & Pack size & MRP Date of application Decision of 249th Composition demanded with diary No. meeting K-Cit Tablet 100’s/ As per PRC 21.10.2013 Registration Board Each extended Dy. No. 19 deferred the release tablet Form – 5 application for contains: Rs. 20,000/- scrutinization as Potassium Rs. 40,000/- per checklist Citrate…1080mg 01.02.2013 approved by (NSAID) Registration Board.

The dossier of the firm has now been scrutinized as per latest check list & found complete. The firm has stated that Urocit – K tablet, Registration No. 039808, M/s Universal Enterprise marketed by Allmed Laboratories is already registered drugs in Pakistan Allmed Laboratories is already registered drugs in Pakistan. Firm has also informed that being an extended release tablet comparative dissolution test with Urocit-K had already been performed in an independent lab HEJ. Research Institute of Chemistry, University of Karachi. The firm has provided sample analysis / comparative dissolution test report. Decision: Registration Board approved the request of the firm for registration of above drug.

b) Registration board in its 243rd meeting deferred registration of following products of M/s Barrett Hodgson Pakistan, Karachi and decided as recorded in last column.

Barizold infusion Rs 500/- Form 5 Me too(Zolrest, of Approved. 400mg/200ml Pack of 1’s Fast Track Bosch) (Confirmation of Infusion 1391 dated 17/07/13 Inspection of the firm Liquid particle Each 200ml vial 16/07/2013 was carried out on 14th counter and TOC contains Linezolid & 15th May 2013 by availability by 400mg area FID and as per area FID) Synthetic report the firm has antibacterial agent good facilities for of oxazolidinone compliance of GMP

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class guidelines. Manufacturer Spec’s

Now the firm has provided the evidence for the availability of TOC analyzer and installation of liquid particles counter. The firm has requested to consider the above product in the light of Registration Board’s M-248th meeting decision for six month relaxation.

Decision: Registration Board approved the request for registration of Barizold infusion 400mg/200ml as per above details.

Case No. 13 Registration of Drugs for export purpose - Not me-too (New Drugs) Following firms have requested for registration of following drugs for export purpose only which are not me-too & are new drugs. Details are as under:-

S.No. Name of Name of product(s) Date of Export International Company application, Order Availability Diary No. & Form 1. M/s. Accemide Injection 1ml ampoule Export order Not Found Medisure Each ml contains not provided Laboratories Furosemide…………………..10mg Pakistan (Pvt.) Limited A-115, S.I.T.E., Super Highway Karachi.

2. -do- Amipine Injection 1ml ampoule -do- Not Found Each ml contains Norepinephrine……….………2mg 3. -do- Acce-Cee Injection 2ml ampoule -do- Not Found Each ml contains Ascorbic acid……………500mg 4. M/s Flu-Gone day & night Capsules 06.11.2015 Copy of Not Found Pharmatec Each combi pack contains: 963 export order Pakistan Day – time Capsule: Rs. 20,000/- from Nairobi (Pvt) Ltd., Paracetamol………………..500mg 09.11.2015 Kenya D-86/A, Pseudoephedrine HCl………30mg Rs. 30,000/- Caffeine Anhydrous………..30mg S.I.T.E., Night –time Capsule: Karachi Paracetamol………………..500mg Pseudoephedrine HCl……….30mg

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Citirizine (as dihydrochloride)…10mg Dextromethorphan HBr………10mg 5. M/s Hiranis Glimbax Mouthwash 0.074% 06.11.2015 Copy of In Italy in 200 Pharmaceuti Each 100ml contains: 964 export order ml cal, D-41, Diclofenac Acid…………0.074% Rs. 50,000/- from Mynmar Block – 4, (Manufacturer Specification) Clifton Karachi 6. -do- Kop Mouthwash 1.6% 06.11.2015 -do- In 150 ml---- Each 100ml contains: 965 Ketoprofen (as lysine salt) Rs. 50,000/- …..1.6mg (manufacturer Specification 7. -do- Dentifen Mouthwash 0.25% 06.11.2015 -do- In Turkey in Each 100ml contains: 966 200 ml Flurbiprofen…………0.25gm Rs. 50,000/- (Manufacturer Specification) 8. -do- Naprozol Tablet 375mg/20mg 30.09.2015 Copy of Not Each delayed-release tablet 960 export order contains: Rs. 50,000/- from Naproxen (enteric coated)….375mg Uzbekistan Esomeprazole magnesium trihydrate eq to esomeprazole……….20mg (Manufacturer’s Specification) 9. -do- Naprozol Tablet 500mg/20mg 30.09.2015 Copy of In UK Each delayed-release tablet 950 export order contains: Rs. 50,000/- from Naproxen (enteric coated)….500mg Uzbekistan Esomeprazole magnesium trihydrate eq to esomeprazole……….20mg (Manufacturer’s Specification) 10. M/s Aspin Sepidyl 5% solution 06.11.2015 Copy of Pharma, Each ml Sepidyl 5% solution 967 export order (Pvt) Ltd., contains: Rs. 50,000/- from 91-Shahrah- Chlorhexidine Gluconate Afghanistan e-Iran, BP….50mg (5%w/v) Block Clifton, Karachi 11. -do- Sepidyl 7.1% Gel 06.11.2015 -do- Each gram gel contains: 968 Chlorhexidine Gluconate Rs, 50,000/- BP….71mg (7.1%w/v) 12. -do- Sepidyl 7.1% solution 06.11.2015 -do- Each gram solution contains: 969

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Chlorhexidine Gluconate Rs, 50,000/- BP….71mg (7.1%w/v) 13. Getz Pharm Starcox tablet 120mg 06.11.2015 Export order In UK (Pvt) Ltd., Each film coated tablet contains: 970 not provided 29-30, Etoricoxib…………120mg Rs. 20,000/- Sector – 27, Korangi Industrial Area, Karachi 14. -do- Starcox tablet 90mg 06.11.2015 Export order In UK Each film coated tablet contains: 972 not provided Etoricoxib………………..90mg Rs. 20,000/- 15. -do- Scipant DR Granules for suspension 06.11.2015 Export order In USA 40mg 971 not provided. Each sachet contains: Rs. 20,000/- Pantoprazole Sodium USP eq to Pantoprazole……………40mg 16. -do- Soviget tablet 400mg 06.11.2015 Export order In USA Each film coated tablet contains 973 not provided. Sofosbuvir……………400mg Rs. 20,000/- 17. M/s Bosch Sivir 400mg tablet 09.11.2015 Copy of In USA Pharmaceuti Each film coated tablet contains: 974 export not cal (Pvt) Sofosbuvir………400mg Rs. 20,000/- provided. Ltd., Bosch (Manufacturer’s Specification) House 221, Sector 23, Korangi Industrial Area, Karachi 18. -do- Cebosh 100mg Sachet 07.05.2014 Copy of Not Found Each sachet contains: 980 Export order Cefixime (as trihydrate)…..10mg Rs. 20,000/- from veitnam 19. M/s Atco Leduvir tablet 400/90mg 09.11.2015 Copy of In USA Laboratories Each film coated tablet contains: 975 Export order Ltd., B-18, Sofosbuvir MS…………..400mg Rs. 20,000/- from Mynmar SITE, Ledipasvir MS…………….90mg Karachi 20. -do- Daclavir 60mg tablet 09.11.2015 -do- In USA Each film coated tablet contains: 976 Daclatasvir hydrochloride eq to Rs. 20,000/- Daclatasvir……….60mg 21. -do- Agrelor 90mg tablet 09.11.2015 -do- In USA Each film coated tablet contains: 977 Ticagrelor……………….90mg Rs. 20,000/- 22. Martin Dow Ozbir Plus tablets 09.11.2015 Copy of In USA

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Plot No. 37, Sofosbuvir………….400mg 978 Export order Sector 19, Ledipasvir……………90mg Rs. 20,000/- from Korangi Myanmar Industrial Area, Karachi 23. OBS Tiglinta 90mg tablet 09.11.2015 Export order In USA Pakistan Each film coated tablet contains: 979 from (Pvt) Ltd., Ticagrelor tablet …………90mg Rs. 20,000/- Afghanistan C-14, Manghopir Road, SITE, Karachi 24. M/s Hilton Dexlan 30mg Capsules 09.11.2015 Copy of In USA Pharma Each capsule contains enteric 992 export order (Pvt) Ltd., coated granules of Rs. 50,000/- from Plot No. Dexlansoprazole…….30mg Afghanistan 13/14, Sector 15, Korangi Industrial Area, Karachi 25. -do- Dexlan 60mg Capsules 09.11.2015 Copy of In USA Each capsule contains: 980 export order Enteric coated granules of Rs. 50,000/- from Dexlansoprazole………..60mg Afghanistan 26. -do- Tapen 50mg tablet 09.11.2015 Copy of In UK Each film coated tablet contains: 981 export order 57.500mg of Tapentadol HCl eq to Rs. 50,000/- from Tapentadol………50 mg Afghanistan 27. -do- Tapen 75mg tablet 09.11.2015 Copy of In UK Each film coated tablet contains: 982 export order 86.25mg of Tapentadol HCl eq. to Rs. 50,000/- from Tapentadol………….75mg Afghanistan 28. -do- Tapen 100mg tablet 09.11.2015 Copy of In USA Each film coated tablet contains: 983 export order 115mg of Tapentadol HCl. Eq. to Rs. 50,000/- from Tapentadol………………100mg Afghanistan 29. -do- Empa-Met 5/500mg 09.11.2015 Copy of In USA Each film coated tablet contains: 986 Export order Empagliflozin…………….5mg Rs. 50,000/- from Metformin HCl…………….500mg Afghanistan 30. -do- Empa-Met 5/1000mg 09.11.2015 Copy of In USA Each film coated tablet contains: 987 export order Empagliflozin…………5mg Rs. 50,000/- from

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Metformin HCl………..1000mg Afghanistan 31. -do- Empa-Met 12.5/500mg 09.11.2015 Copy of In USA Each film coated tablet contains: 988 export order Empagliflozin……….12.5mg Rs. 50,000/- from Metformin HCl………..500mg Afghanistan 32. -do- Empa-Met 12.5/1000mg tablet 09.11.2015 Copy of In USA Each film coated tablet contains: 989 export order Empagliflozin…………12.5mg Rs. 50,000/- from Metformin HCl…………1000mg Afghanistan 33. -do- Tetravir Tablets 09.11.2015 Copy of Not Each film coated tablet contains: 990 Export order Ombitasvir………………12.5mg Rs. 50,000/- from Paritaprevir………………75mg Afghanistan Ritonavir…………………50mg Each film coated tablet contains: 270.3mg dasabuvir sodium monohydrate eq to dasabuvir…………………...250mg 34. -do- Zeegap Oral Solution 09.11.2015 Copy of In USA Each ml contains: 991 Export order Pregabalin………………....20mg Rs. 50,000/- from Afghanistan

Decision: Registration Board was apprised that in 241st and 246th meeting it was decided that registration of new drugs / formulations for export purpose will be granted if applicant provide import order of any country. Registration Board deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. Accordingly, above case was decided as follows:  Approved grant of registrations for export purpose for above items except at S.No. 1-8, 10-12, 18 and 33. Firm will deposit remaining fee for grant of registration and Chairman, Registratiuon Board will then permit isuuance of export registration letter. Manufacturer will comply following conditions before export of drug: a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product. c. Deferred items at S.No. 1-8, 10-12, 18 and 33 for deliberation in forthcoming meeting as decided above

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b) Registration Board in 237th meetings deferred following registration application of M/s Macter International Limited, F-216, SITE, Karachi for reason mentioned in last column:

1. -do- Venticort Rotacaps Not Rs.10/- 13-06-2012 Deferred for 100mcg+6mcg mentioned Per cap Dy.No.112 confirmation Capsule 3 of steroidal Each capsule contains: Form-5 manufacturing Budesonide……….…100 mcg Rs.8000/- facility Formoterol fumarate Rs.52,000/- dihydrate……………….6 mcg 23-1-2013 (Corticosteroid / B-agonist) 2. -do- Venticort rotacaps Not Rs.15/- 12-06-2012 -do- 200mcg+6mcg mentioned Per tab Dy.No.107 Each capsule contains: 9 Budesonide……….…200 mcg Form-5 Formoterol Fumarate Rs.8000/- dihydrate……………….6 mcg Rs.52,000/- (Corticosteroid) 23-1-2013 3. -do- Venticort rotacaps Not Rs.20/- 12-06-2012 -do- 400mcg+6mcg mentioned Per tab Dy.No.108 Each capsule contains: 0 Budesonide…………400 mcg Form-5 Formoterol Fumarate Rs.8000/- dihydrate…………..….6 mcg Rs.52,000/- (Corticosteroid) 23-1-2013

Now the firm has stated that the Board referred the case to committee comprising of Brig ® Prof. Muzammil Hasan Najmi (Member Registration Board), Dr. Taufeez ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam University, Islamabad (Member Registration Board), DDG (R-II) and concerned DDC for secruitinization, verification of codal requirements and recommendations for me-too registration application. The recommendations of committee will be submitted to Chairman, Registration Board for decision. However, the Registration Board has observed in 246th, 247th and 248th meeting since their product contains “Budesonide” as one of the API which is a corticosteroid therefore, based on the conclusion of above Registration Board meetings they would like to request to grant the registration of said product on toll manufacturing at manufacturing site of Hirani Pharmaceutical (Pvt) Ltd., (DML 000785) which have approved dedicated steroidal capsule (Oral) section. Otherwise grant the registration for the manufacturing of said product at their own confined

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capsule manufacturing section (Macter International Limited, DML: No. 000141) as per their initial application (June, 2012) at the earliest in the interest of patient under treatment with these drugs. Decision: Registration Board deferred request of firm for confirmation of approval status by reference drug regulatory authorities.

Case No. 14 Registration of drugs (change of title only) M/s Martin Dow Ltd, Karachi has informed that the Licensing Board in its 235th meeting has approved the change of company name from M/s Martin Dow Pharmaceutical Ltd, Karachi to M/s Martin Dow Ltd., Karachi DML No. 000267. The firm has therefore, applied for transfer of registrations of following products on form 5 to their new title:

S.# Regn. Product name Renewal up Remarks No. to 1. 010197 Synflex Tablet 550mg 28.06.2020 - Each film coated tablet contains Naproxen sodium……550mg (USP Specifications) 2. 008777 Proxen Tablet 500mg 28.06.2020 - Each tablet contains Naproxen…………..…500mg (USP Specifications) 3. 014929 Dormicum Ampoule 5mg/5ml 28.06.2020 -` Each ml contains Midazolam………….5mg (Manufacturer’s Specification) 4. 008778 Proxen Tablet 250mg 28.06.2020 - Each tablet contains: Naproxen…………..250mg (USP Specifications)

In support the firm has submitted following documents: 7) Required fee as per relevant SRO Rs. 20,000/- for each product. 8) Application on form -5 9) Copy of registration letter/renewal status. 10) Copy of NOC for CRF clearance. 11) Approval of new name/title from CLB 12) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.

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Decision: Keeping in view decision in 246th meeting, Registration Board approved registration of above four products in name of M/s Martin Dow Ltd, Karachi.

b) M/s Brookes Pharma (Pvt) Ltd.,58-59, Sector No. 15, Korangi Industrial Area, Karachi has applied for transfer of registration from Brookes Pharmaceutical Laboratories (Pakistan) Limited to Brookes Pharma (Pv) Ltd., Karachi. The firm has therefore, applied for transfer of registrations on form – 5 of following products to their new title:

S.# Regn. Product name Renewal up Remarks No. to 1. 057727 Entapin Injection 08.06.2019 - Each ml contains: Pentazocine as lactate….30mg (manufacturer Specification) 2. 061402 Fentra 5ml injection 12.05.2020 - Each ml contains Fentanyl as citrate……0.05mg (USP specification) 3. 025497 D-Cort Injection 10.12.2019 - Each ml contains: Dexamethasone sodium, Phosphate eq to Dexamethasone………4mg 4. 022817 Hypozam Injection 11.12.2018 Each ml contains Midazolam……….1mg 5. 047346 Xylepam 0.5mg tablet 11.12.2018 Each tablet contains Alprazolam…………0.5mg (BP Specification) 6. 057728 Benorine Injection 08.06.2019 Each ml contains: Buprenorphine as HCL…..0.30mg (BP specification) 7. 061401 Fentra 2ml Injection 08.06.2019 Each ml contains Fentanyl as citrate…0.05mg As Fentanyl Citrate USP)

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The firm has informed that due to change in name/title of manufacturer (site of manufacturing remains the same) In support the firm has submitted following documents: 1) Required fee as per relevant SRO Rs. 20,000/- for each product. 2) Application on form -5 3) Copy of registration letter/renewal status. 4) Copy of NOC for CRF clearance. 5) Approval of new name/title from CLB 6) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.

Decision: Keeping in view decision in 246th meeting, Registration Board approved registration of products at S. No. 1, 2, 4, 5, 6 & 7 from Brookes Pharmaceutical Laboratories (Pakistan) Limited and register in the name of M/s Brookes Pharma (Pvt) Ltd.,58-59, Sector No. 15, Korangi Industrial Area, Karachi. Product at S.No.3 was deferred for confirmation of approval status by reference drug regulatory authorities.

d. M/s. Pliva Pakistan (Pvt) Ltd, Karachi. Following product is registered for M/s Mehran International, 498/D, Hume Road, Quaideen Colony Opposite: World Map, Near 3 Star Hall, Karachi Pakistan for import from M/s. Pliva Zagreb Croatia, Yogoslavia and now M/s. Pliva Pakistan (Pvt) Ltd, Karachi have requested for transfer of registration of the following registered imported drug from the name of aforementioned agent for local manufacturing.

S. No. Reg. No. Name of Products Demanded price 1. 008619 Amoxicillin Injection 500mg 1x10 vials Each vial contains: Rs. 280/- Amoxicillin as sodium salt…… 500mg 1x50vials Rs. 880/-

The applicant M/s. Pliva Pakistan (Pvt) Ltd. Karachi has submitted following documents:- i) Copy of registration letter and renewal status ii) NOC from M/s Mehran International, Karachi for manufacturing of Amoxycillin Injection 500mg (Reg No 008619). iii) NOC from M/s Pilva Zagreb, Croatia for Amoxycillin Injection 1gm (Reg No 008619). iv) Form 5 v) Copy of last inspection report

Decision: Registration Board deferred request of the firm for confirmation of renewal status.

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Case No. 15 Registration of product from M/s Macter to M/s Ray Pharma, Karachi.

Registration Board in its 246th meeting deferred the following formulation for review of by the review committee since it was not found approved in SRAs (reference drug agencies). While considering the request of the firm for transfer of registration from M/s Macter to its name. Now the firm has requested to approve the above request as they are ready to change their label claim as per formulation approved by SRAs i.e. Genticyn HC Ear Drops Registration No. 004298 instead of Genticyn HC Ear/Eye Drops. S.# Regn. No. Name and Composition 1 004298 Genticyn HC Ear / Eye Drops Gentamycine (as sulphate) ………..0.3%w/v Hydrocortisone acetate……………..1% w/v

Decision: Registraion Board approved the request of the firm for correction in the label claim / description of the product as per approval in the reference agencies.

Case No.16: Correction in minutes of Registration Board. The Registration Board in its 246th meeting approved the following products in the name of M/s Ray Pharma, Karachi and cancels the registration from M/s Macter International while considering the request of the firm (M/s Ray Pharma) for transfer of registration from M/s Macter International, Karachi to its name: S. Reg. No. Name of Drug(s) Recommendations No. 01 000482 Genticyn Ear / Eye May be approved subject to confirmation Drops of renewal status

Inadvertently while recording the decision / minutes of registration board the registration number of the formulation was mentioned as 010186 instead of 000482. The requested for correction in registration number of above product

Decision: Registration Board approved the correction in the registration number of the product.

Minutes for 254th Registration Board Meeting 455

b. Registration from M/s OBS Pakistan, Karachi to M/s AGP (Pvt) Ltd., Karachi.

Registration Board in its 252nd meeting approved following products in the name of M/s AGP (Pvt) Ltd., Karachi which was previous registered in the name of M/s OBS Pakistan, Karachi. Now the firm has pointed out by the firm that in its original request it was also requested for change in brand name alongwith transfer of registration of following products. S. Reg. No. Name of product(s) & composition Renewal Validity No. 1. 055574 Vicopin 500mcg Tablet 30.03.2019 Each tablet contains: Mecobalamin……500mcg (Manufacturer’s specifications) 2. 076211 Vicopin 500mcg/ml Injection 28.01.2019 Each ml contains: Mecobalamin……500mcg (Manufacturer’s specifications)

Decision: Registration Board approved the request of the firm for change in brand names of above products to Mecovate.

Case No. 17 Change of primary packaging M/s Abbott Laboratories, Karachi have applied for change in coating of their already registered product Brufen tablet 200mg & 400mg from sugar coating to film coating. In support, the firm has provided following documents: a) Stability studies approved protocol. b) Chromatograms. c) Stability studies conducted with previous/existing coating for comparison. d) An undertaking that the stability studies would be continued till proposed shelf life & incase of any OOS (out of specification). e) Comparative dissolution profile data on two batches with new & previous coating. f) All related information like release specifications, significant change, batch size details, hardness testing etc.

Additionally the firm have also provided following documents:

a) NOC for clearance of CRF. b) Justification of proposed change. c) Shelf life will remain the same justified by stability studies submitted with commitment to continue till complete shelf life.

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Decision: Registration Board approved the request of the firm for change in coating from sugar coating to film coating of their already registered product Brufen tablet 200mg & 400mg.

Case No.18 Transfer of Registration from Import to Local.

M/s OBS Pakistan, Karachi have applied for transfer of following product from import to local manufacturing at their own site. They have stated that they will continue to import the product from present source till June, 2016. S. Reg. Name of drug(s) & composition Renewal Status in the No. Status reference No. valid upto Drug agencies 1. 028964 Fortzaar Tablets 10-06-2015 Available in Each film coated tablet contains:- UK Losartan Potassium………100mg Hydrochlorothiazide……..25mg

The firm possessing the manufacturing facility for the above product as per inspection report for renewal of DML by the Licensing dated 8th July, 2015

Decision: Registration Board deferred the request of the firm for confirmation of renewal status of the above product and clarification as firm has stated to continue import till June, 2016.

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Registration-III Case No.19. Applications for extension in Contract Manufacturing Permission.

S. No. Name of Applicant Name of Reg. No. Name of drug(s) & Date of Category Date up to which Contract Composition application, contract manufacturer Diary No. & manufacturing Form permission valid (Registration Board meeting in which previous approval was granted)

12. M/s Harrison M/s Astellas 054052 Haricef 100mg Suspension 30-06-2015 Extension 31-05-2011. Pharmaceuticals Pharmaceuticals Each 5ml contains:- Dy. No.1637 Previous contract 10-KM Lahore Road, (Pvt) Ltd, Cefixime……….100mg Rs.50,000/ manufacturing Sargodha Hayatabad, (USP Specification) permission hass not Peshawar been submitted by the firm.

13. -do- -do- 054053 H-bect 2gm Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefoperazone (as Rs.50,000/ manufacturing Sodium)……..1000mg permission hass not Sulbactum (as been submitted by the Sodium)…….1000mg firm. (Manufacturer’s Specifications)

14. -do- -do- 054054 Harion 250 Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Ceftriaxone (as Rs.50,000/ manufacturing Sodium)……….250mg permission hass not (USP Specification) been submitted by the firm.

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15. -do- -do- 054055 Haritax 1gm Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefotaxime (as Rs.50,000/ manufacturing Sodium)……..1000mg permission hass not (USP Specification) been submitted by the firm. 16. -do- -do- 054056 H-Dox 125mg Suspension 30-06-2015 Extension 31-05-2011. Each 5ml contains:- Dy. No.1637 Previous contract Cefadroxil (as Rs.50,000/ manufacturing Monohydrate)……125mg permission hass not (USP Specification) been submitted by the firm.

17. -do- -do- 054057 H-Dox 250mg Suspension 30-06-2015 Extension 31-05-2011. Each 5ml contains:- Dy. No.1637 Previous contract Cefadroxil (as Rs.50,000/ manufacturing Monohydrate)……250mg permission hass not (USP Specification) been submitted by the firm.

18. -do- -do- 054058 Haricef 400mg Capsules 30-06-2015 Extension 31-05-2011. Each capsule contains:- Dy. No.1637 Previous contract Cefixime………400mg Rs.50,000/ manufacturing (Manufacturer permission hass not Specification) been submitted by the firm. 19. -do- -do- 054059 Harion 500mg Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Ceftriaxone (as Rs.50,000/ manufacturing Sodium)………500mg permission hass not (USP Specification) been submitted by the firm.

20. -do- -do- 054060 Harion 1gm Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Ceftriaxone (as Rs.50,000/ manufacturing

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Sodium)………1000mg permission hass not (USP Specification) been submitted by the firm. 21. -do- -do- 054061 Haritax 250mg Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefotaxime (as Rs.50,000/ manufacturing Sodium)……250mg permission hass not (USP Specification) been submitted by the firm. 22. -do- -do- 054062 H-dox 500mg Capsules 30-06-2015 Extension 31-05-2011. Each capsule contains:- Dy. No.1637 Previous contract Cefadroxil (as Rs.50,000/ manufacturing Monohydrate)……500mg permission hass not (USP Specification) been submitted by the firm.

23. -do- -do- 054063 Haritax 500mg Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefotaxime (as Rs.50,000/ manufacturing Sodium)……500mg permission hass not (USP Specification) been submitted by the firm.

24. -do- -do- 057527 H-bect 1gm Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefoperazone as Rs.50,000/ manufacturing Sodium……..500mg permission hass not Sulbactum as been submitted by the Sodium…….500mg firm. (Manufacturer’s Specifications)

25. -do- -do- 059677 Hari-pime 500mg Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefipime (as HCl with Rs.50,000/ manufacturing L-Arginine)………500mg permission hass not

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(USP Specification) been submitted by the firm.

26. -do- -do- 059678 Hari-pime 1gm Injection 30-06-2015 Extension 31-05-2011. Each vial contains:- Dy. No.1637 Previous contract Cefipime (as HCl with Rs.50,000/ manufacturing L-Arginine)………1gm permission hass not (USP Specification) been submitted by the firm.

27. M/s Trison Research M/s Synchro 045476 Penxime 100mg Dry 30-06-2015 Extension Previous contract Laboratories (Pvt) Pharmaceuticals, Powder Suspension Dy. No.1638 manufacturing Ltd., Sargodha. 77-Industrial Each 5ml contains:- Rs.50,000/ permission hass not Estate Kot Cefixime (as been submitted by the Lakhpat, Lahore. trihydrate)……..100mg firm.

28. -do- -do- 045477 ARK 1gm Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Cefepime (as Rs.50,000/ permission hass not Hydrochloride)…1000mg been submitted by the firm.

29. -do- -do- 045478 ARK 500mg Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Cefepime (as Rs.50,000/ permission hass not Hydrochloride)…500mg been submitted by the firm.

30. -do- -do- 045479 Jostle 250mg Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Ceftriaxone (as Rs.50,000/ permission hass not Sodium)………250mg been submitted by the (USP Specifications) firm.

31. -do- -do- 045480 Jostle 500mg Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing

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Ceftriaxone (as Rs.50,000/ permission hass not Sodium)………500mg been submitted by the (USP Specifications) firm.

32. -do- -do- 045481 Jostle 1gm Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Ceftriaxone (as Rs.50,000/ permission hass not Sodium)………1000mg been submitted by the (USP Specifications) firm.

33. -do- -do- 045482 Pert 250mg Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Cefotaxime (as Rs.50,000/ permission hass not Sodium)…….250mg been submitted by the firm.

34. -do- -do- 045483 Pert 500mg Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Cefotaxime (as Rs.50,000/ permission hass not Sodium)…….500mg been submitted by the firm.

35. -do- -do- 045484 Pert 1gm Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Cefotaxime (as Rs.50,000/ permission hass not Sodium)…….1000mg been submitted by the firm.

36. -do- -do- 045487 Pender 2gm Injection 30-06-2015 Extension Previous contract Each vial contains:- Dy. No.1638 manufacturing Cefoperazone (as Rs.50,000/ permission hass not Sodium)………1000mg been submitted by the Sulbactum (as firm. Sodium)………1000mg

37. -do- -do- 045488 Pender 1gm Injection 30-06-2015 Extension Previous contract

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Each vial contains:- Dy. No.1638 manufacturing Cefoperazone (as Rs.50,000/ permission hass not Sodium)………500mg been submitted by the Sulbactum (as firm. Sodium)………500mg

Decision: Registration Board deferred the above cases for evaluation in light of Rule 20 A of Drugs (L, R &A) Rules, 1976 (Contract Manufacturing , Policy).

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Case No.20.

Registration Board in its 236th meeting deferred the following product firm M/s Danas Pharmaceuticals (Pvt) Ltd, Islamabad for the reasons mentioned in the last column as below:-

S. Name of the Brand Name / Label Demand Fee Previous Decision No. Firm. Claim ed Pack Submitt M-236 Size/ ed Price 1. M/s Danas Vegadon SR 3mg 20’s 19-11- Deferred Pharmaceuti Tablets 30’s 2012 for consideration by the cal (Pvt) Each sustained Rs.60,0 Board as the product is new Ltd, release tablet As Per 00 molecule along with the Islamabad. contains:- SRO submission of following:- Paliperidone 1. Methylene Chloride be ………..3mg replaced with some other (Neuroleptic / suitable film coating Dompamine material. Antagonist) 2. Submission of comparative dissolution profile with established brand locally or internationally (in case of new drug / new dosage form / new combination). This data will be supported by relevant documents including purchase of raw material, Certificate of Analysis, testing protocols, SOPs, analytical data and finished sample. 3. Remaining Fee Rs.90,000/=

2. -do- Vegadon SR 6mg 20’s 19-11- -do- Tablets 30’s 2012 Each sustained Rs.60,0 release tablet:- As Per 00 Paliperidone SRO ………..6mg (Neuroleptic / Dompamine Antagonist)

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3. -do- Vegadon SR 9mg 20’s 19-11- -do- Tablets 30’s 2012 Each sustained Rs.60,0 release tablet:- As Per 00 Paliperidone SRO ………..9mg (Neuroleptic / Dompamine Antagonist)

The firm has now submitted the following documents:-

1. Certificate of analysis. 2. Master Formulation. 3. Standard operating procedure. 4. Comparative Dissolution profile. 5. Copy of receiving of fee Rs.90,000/- per product.

Decision: Registration Board approved request of the firm for registration of above three products for M/s Danas Pharmaceuticals (Pvt) Ltd, Islamabad

Case No.21.

Registration Board in its 237th meeting M/s Danas Pharmaceuticals (Pvt) Ltd, Islamabad.

S. Brand Name / Label Demande Demand Decision No Claim d Pack ed Price M-237 Size 1. Salden 20mg Injection 1mlx5’s As Per Approved subject to Each ml contains:- SRO submission of tests Piroxicam ……… 20mg for Injectable dosage (NSAIDs) forms like clarity test, particulate mater test.

The firm has now submitted all the required documents related to tests for injectable dosage forms like clarity test and particulate mater test and requested for grant of registration of above product. The product has not been approved in FDA and UK but approved in France.

Decision: Registration Board approved the above formulation / product for registration.

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Case No.22.

Registration Board in its 235th meeting deferred the following product firm M/s Biogen Pharma Rawat, Islamabad for the reasons mentioned in the last column as below:-

S. Brand Name / Label Claim Demanded Demande Decision of Committee No. Pack Size d Price (M-235)

1. Avega 3mg Tablets 10’s As per Approved if the product is Each sustained release tablet 30’s SRO me-too otherwise the firm has contains:- 40’s to apply afresh on form 5-D alongwith requisite fee. Paliperidone ……… 3mg (Benzisoxazole Derivatives)

2. Avega 6mg Tablets 10’s As per -do- Each sustained release tablet 30’s SRO contains:- 40’s Paliperidone ……… 6mg (Benzisoxazole Derivatives)

The firm has stated that it was new when applied. Now it has become me-too as registered in the name of M/s Pharmatec Pharmaceuticals, Karachi and M/s Genome Pharmaceutical Hattar. The letter for the approval of above formulation for M/s Genome has been approved by Registration Board in its 250th meeting and its registration letter is in the process of issuance. Further it has been found that the above formulation in extended release dosage form instead of immediate release form as applied by the firm.

Decision: Registration Board approved request of the firm for registration of above product.

Case No.23.

Registration Board in its 228th meeting deferred the following product firm M/s Valor Pharmaceuticals, Islamabad for the reasons mentioned in the last column as below:-

S. Brand Name / Label Claim Demande Approved Decision of No. d Pack MRP, Pack Meeting Size & size with (M-228) Price reference of meeting 1. Germolene Cream 30gm Rs.45.00/ Approved Each gm contains:- 30gm Subject to Phenol………………...…….1.2 As Per satisfactory GMP

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% SRO 18th PAC Inspection Report Chlorhexidine digluconate…0.25% w/w (Valor’s Specifications )

2. Atedon 25mg Tablets 20’s Rs.35.00/ -do- Each tablet contains:- 20’s Chlorthalidone…………25mg As Per (Valor’s Specifications ) SRO 18th PAC

The firm has deposited Rs.8000/= at the time of approval. Now, it has paid the remaining amount Rs.12,000/= for each product along with the GMP inspection report.

Decision: Registration Board deferred request of the firm for confirmation of Me-too status. Otherwise firm has to apply on form-5 D alongwith relevant fee.

Case No.24.

M/s Atco Laboratories Limited Karachi have requested that their registered brand Betagenic has resemblance with Betagent of M/s Valor Pharmaceuticals Islamabad. DRAP has issued 2 reminders to M/s Valor Pharma to change the brand name having resemblance but the firm has not complied so far. M/s Atco Laboratories have requested for necessary action to be taken by the Registration Board:

S. Company Brand Generic Dosage Reg. Date of No Name Name Form No. Reg. 3. M/s Atco Betagenic Betamethasone Cream 027538 23-05- Laboratories dipropionate….0 2002 Karachi .05% Gentamycin….. 0.1%

4. -do- -do- -do- Ointment 058357 13-08- 2009 5. M/s Valor Betagent Betamethasone Cream 027867 01-07- Pharma dipropionate 2002 Islamabad …0.05% Gentamycin …. 0.1%

6. -do- -do- -do- Ointment 065248 28-07- 2010

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Decision: Registration Board deliberated that as registration granted to Betagenic cream & ointment, Registration No. 027538 & 058357 of M/s Atco Laboratories, Karachi is prior to Betagent cream & ointment Registration No. 027867 & 065248 of M/s Valor Pharma Islamabad, thus later or the successor firm (M/s Valor Pharma Islamabad) will be issued show cause to change its brand name as per Registration Board’s decision taken in its M-242nd meeting.

Case No.25.

Registration Board in its 246th meeting deferred the following product firm M/s Caraway Pharmaceutical Rawat, Islamabad for the reasons mentioned in the last column as below

7. M/s Caraway Ondenles 8mg Injection As per Deferred for the Pharmaceuticals, (ampoule) SRO followings: 1. Confirmation of Islamabad. Each ml contains: installation and Ondansetron (as hydrochloride operational qualifications dihydrate)………. ……2mg of TOC analyser and (USP Specifications) liquid particle counter by (5HT-3 Antagonist) FID. 2. Latest inspection report is required.

Now the firm has requested to consider their product in the light of current policy.

Decision: Registration Board approved the request of the frim for registration of above product.

Case No.26.

Registration Board in its 234th meeting approved the following product of firm M/s Nimrall Laboratories, Rawat, Islamabad:-

S. Brand Name / Label Claim Demanded Approved MRP, Decision of No. Pack Size & Pack size with Meeting Price reference of (M-234) meeting 8. Boncal 1.0mcg Injection 1mlx10’s Rs.1760.00/ Approved Each ml contains:- Amps. 1mlx10’s Calcitriol…………1.0mcg As Per SRO 18th PAC

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The firm has requested for grant of registration of above product. Decision: Registration Board approved the request of the firm for registration of above product. Condition will be mentioned in registration letter that firm will purchase and perform installation and operational qualifications of TOC analyser and liquid particle counter in six months time

Case No.27.

Registration Board in its 252nd meeting rejected the product at Sl.No.1 in the light of decision of Registration Board M-250 and deferred the rest of the products for confirmation of their status in reference agencies while considering the request of the firm M/s Vision Pharmaceuticals, Islamabad to transfer these following products from their previous site Plot No.224, Street No.1, I-10/3, Islamabad to new site Plot No.22-23, Industrial Triangle, Kahuta Road, Islamabad:

S. Name of the Reg.No Brand Name / Label Claim Demand Demand Date of No Firm. . ed Pack ed Price Submission Size 1. M/s Vision 033768 Artilide 100mg Tablets 2x10’s As Per 03-07-2015 Pharmaceuticals. Each tablet contains:- SRO Dy.No.1526 Islamabad. Nimesulide………..100mg Rs.20,000/= 2. -do- 030702 Cartiofex 100mg Tablets 2x10’s As Per 03-07-2015 Each tablet contains: SRO Dy.No.1526 Celecoxib………..100mg Rs.20,000/= 3. -do- 030703 Cartiofex 200mg Tablets 20’s As Per 03-07-2015 Each tablet contains:- SRO Dy.No.1526 Celecoxib…………..200mg Rs.20,000/= 4. -do- 030705 Clinex 500mg Tablets 1’s As Per 03-07-2015 Each vaginal tablet SRO Dy.No.1526 contains:- Rs.20,000/= Clotrimazole…….500mg 5. -do- 037574 Diclovis -K 75mg Tablets 2x10’s As Per 03-07-2015 Each tablet contains:- SRO Dy.No.1526 Diclofenac Rs.20,000/= potassium….75mg 6. -do- 041731 Mytamin 500mcg Capsules 100’s As Per 03-07-2015 Each capsule contains: SRO Dy.No.1526 Mecobalamin……500mcg Rs.20,000/= 7. -do- 041730 Sebastin 10mg Tablets 10’s As Per 03-07-2015 Each tablet contains: SRO Dy.No.1526 Ebastine…..……10mg Rs.20,000/=

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8. -do- 041732 Visobac 250mg Capsule 10’s As Per 03-07-2015 Each capsule contains: SRO Dy.No.1526 Ciprofloxacin hydrochloride Rs.20,000/= …….250mg 9. -do- 041737 Visobac 500mg Capsules 10’s As Per 03-07-2015 Each capsule contains: SRO Dy.No.1526 Ciprofloxacin hydrochloride Rs.20,000/= ….500mg

Now the firm has requested to review the above decision of rejection / deferment of above products since hundreds of companies in the country are manufacturing these formulations and the patients will be devoid of these products. The firm has assured that one ever the review committee will decide about the above formulation he will comply his decision.

Decision: Registration Board re-examined the formulations in the light of firm’s request and decided as under:

a. Registration Board in 250th meeting has rejected the formulation at S.No.1 and decided to issue show cause notice to for de-registration of registered drugs containing Nimesulide. b. The product at S. No. 4 is approved for as found approved in MHRA. c. Registration Board in 250th meeting has decided that products at S.No.6, 8 and 9 will not be granted as not approved by reference regulatory authorities and will proceed as per decision of 250th meeting. d. Products at S.No.2, 3, 5 and 7 will be discussed in light of approval status in reference regulatory authorities.

Case No.28. Application for registration of drugs for export purpose only.

S. Name of Brand Name / Deman Deman Date of Remark International No. the Firm. Label Claim ded ded initial s availability Pack Price application Size with fee, date of differential fee deposited 1. M/s Glucimin 1/4mg 30’s As Per 02-11-2015 Copy of Tentative Wenovo Tablets SRO Dy.No.185 export approval in Pharmaceut Each tablet 8 order USA icals contains:- Fee from Taxila Glimepiride..1mg Rs.20,000/ England Rosiglitazone as = Maleate……4mg

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(Wenovo’s Specifications) (Antidiabetic) 2. -do- Glucimin 2/4mg 30’s As Per 02-11-2015 Copy of Tentative Tablets SRO Dy.No.186 export approval in Each tablet 1 order USA contains:- Fee from Glimepiride..2mg Rs.20,000/ England Rosiglitazone as = Maleate…….4mg (Wenovo’s Specifications) (Antidiabetic)

3. -do- Glucimin 4/4mg 30’s As Per 02-11-2015 Copy of Tentative Tablets SRO Dy.No.185 export approval in Each tablet 7 order USA contains:- Fee from Glimepiride..4mg Rs.20,000/ England Rosiglitazone as = Maleate…….4mg (Wenovo’s Specifications) (Antidiabetic)

4. M/s Pedikulin 120ml As Per 04-11-2015 Copy of Caraway Shampoo 1% SRO Dy.No.192 export Pharmaceut Each 100ml 2 order icals contains:- Fee from Rawat Permethrin….1g Rs.20,000/ Tajikista n Islamaba m =

d.

5. M/s Sunny-D Softgel 1’s As Per 10-11-2015 Copy of Scotmann Each softgel SRO Dy.No.170 export Pharmaceut contains:- 9 order icals Vitamin D3 Rs.50,000/ from Islamaba (Cholecalciferol) = Afghani stan d. …200000 IU

(Vitamin Supplement)

6. M/s Nogram 500mg N.A. As Per 29-07-2015 Copy of Global Capsules SRO Dy.No.160 export Pharmaceut Each capsule 8 order icals contains:- Rs.20,000/ not Islamaba Nalidixic = provide Minutes for 254th Registration Board Meeting 471

d. Acid……500mg d (Global’s Specifications)

7. M/s Serra Forte 10mg ------Copy of Paramoun Tablets export t Each film coated order Pharmaceut tablet contains:- from icals Serratiopeptidase Islamaba ………10mg d (equivalent to 20000 serratiopeptidase units)

Decision: Registration Board was apprised that in 241st and 246th meeting it was decided that registration of new drugs / formulations for export purpose will be granted if applicant provide import order of any country. Registration Board deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. Accordingly, above case was decided as follows:  Approved grant of registrations for export purpose for items at S.No. 1, 2 and 3. Firm will deposit remaining fee for grant of registration and Chairman, Registratiuon Board will then permit isuuance of export registration letter. Manufacturer will comply following conditions before export of drug: a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product. c. Deferred items at S.No. 4, 5 and 6 for deliberation in forthcoming meeting as decided above .

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Registration-IV

Case No.29 Request of M/s. Weather Fold for transfer of registration from contract to own facility

M/s. Weather Fold Pharmaceuticals Hattar has requested for change of following registered product from contract manufacturing by M/s. Welamrk Pharmaceuticals, Hattar to their own manufacturing facility:-

052938 M/s. Weather Fold Helcobal 500mcg Injection Rs.20000/- Pharmaceuticals, Each 1ml ampoule contains:- 12-03-2015 Hattar Mecobalamine……….500mcg

052941 -do- Esold Injection Rs.20000/- Each vial contains:- 12-03-2015 Esomeprazole Lyophilized powder…………….40mg

-do- OMEP Injection 40mg Approved Each vial contains:- Omeprazole sodium eq to Omeprazole……… 40 (Proton Pump inhibitor) (Manufacturer Specs)

The above mentioned products are already registered in the name of firm on contract manufacturing basis. However, the firm has also made separate fresh applications for the above mentioned products to Evaluation Cell for manufacturing in their newly approved Liquid Injectable Section. Decision: Registration Board rejected the above applications as these have already been taken up by PEC as fresh applications and considered by the Board in 249th meeting.

Case No.30 Request for Registration for export purpose. The following firm have requested for registration of registration of drugs for the purpose of export only:-

1 M/s. Aries Sovir 400mg Tablets Original Export Pharmaceuticals, Each film coated tablet contains:- order/request Peshawar Sofosbuvir……………. 400mg provided. (Aries Specification)

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2 -do- Prolong 60mg Tablets -do- Each film coated tablet contains:- Dapoxetine(as HCl)……..60mg (Aries Specification)

Decision: Registration Board registered above products exclusively for export purpose. Manufacturer will comply following conditions before export of drug:  Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No objection certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi.

 Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to ensure export of the product.

Case No.31. Extension/Change of Contract Manufacturing Permission.

M/s. CSH Pharmaceuticals, Peshawarhe following firm requested for extension in permission of toll manufacturing and also requested for change of toll manufacturer as per following details.

S.No Applicant Contract Reg. Name of drug(s) & Date of Validity of manufacturer No. Composition applicatio last n, permission Diary No. & Form 1 M/s. CSH M/s. Medisave 044092 Cealth 250 mg 30-06-2015 30-06-2015 Pharmaceuticals Pharmaceuticals Injection Dy Firm has , Peshawar , Lahore Each vial contains:- No.3638 requested for Cefuroxime Sodium Rs.50,000/- change of ≡ Cefuroxime...250 mg 30-6-2015 contract manufacturer to M/s. Astellas Pharmaceuticals , Peshawar 2 -do- -do- 044093 Cealth 750 mg 30-06-2015 -do- Injection Dy Each vial contains:- No.3640 Cefuroxime Sodium Rs.50,000/- ≡ Cefuroxime..750 mg 30-6-2015

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3 -do- -do- 044094 Cealth 1.5 gm 30-06-2015 -do- Injection Dy Each vial contains:- No.3634 Cefuroxime Sodium Rs.50,000/- ≡ Cefuroxime….1.5 g 30-6-2015

4 -do- -do- 044098 Injectazone Plus 1 gm 30-06-2015 -do- Injection Dy Each vial contains:- No.3641 Cefoperazone Sodium Rs.50,000/- ≡ Cefoperazon..500 mg 30-6-2015 Sulbactam Sodium ≡ Sulbactam...500 mg (USP Specification)

5 -do- -do- 044099 Injectazone Plus 2 gm 30-06-2015 -do- Injection Dy Each vial contains:- No.3635 Cefoperazone Rs.50,000/- Sodium 30-6-2015 ≡ Cefoperazon.....1 gm Sulbactam Sodium ≡ Sulbactam..1 gm (USP Specification) 6 -do- -do- 044100 Injectacef 250 mg 30-06-2015 -do- Injection I.V. Dy Each vial contains:- No.3642 Ceftriaxone Sodium Rs.50,000/- ≡Ceftriaxone…250 mg 30-6-2015 7 -do- -do- 044101 Injectacef 1 gm 30-06-2015 -do- Injection I.V Dy Each vial contains:- No.3639 Ceftriaxone Sodium Rs.50,000/- ≡Ceftriaxone….1 gm 30-6-2015

8 -do- -do- 044102 Cefgram 500 mg 30-06-2015 -do- Injection Dy Each vial contains:- No.3636 Cefepime HCl & L- Rs.50,000/- arginine 30-6-2015 ≡ Cefepime….500 mg

9 -do- -do- 044103 Cefgram 1 gm 30-06-2015 -do- Injection Dy Each vial contains:- No.3637 Cefepime HCl & L- Rs.50,000/-

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arginine 30-6-2015 ≡ Cefepime…..1 gm

Decision: Registration Board approved extension in contract manufacturing permission of above products for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.

Case No.32.

M/s. Weather Fold Pharmaceuticals, Hattar has requested for change of following products from toll manufacturing by M/s. Welmark Pharmaceuticals, Hattar to their own manufacturing unit:-

Reg No. Name of Drugs with Composition S.No 1 052997 Esold 40 mg Capsule Each capsule contains:- Esomeprazole enteric coated pellets 22.5% w/w ≡ Esomeprazole .………40 mg

2 056052 Helcobal 500 mcg Tablets Each film coated tablet contains:- Mecobalamine………….…..500 mcg

Now the management of the firm submitted required document i.e. Dossiers, fee of Rs. 20000/- each and approval of section from Licensing Unit. The dossiers have been evaluated accordingly.

Decision: Registration Board acceded request of the firm for change of the above mentioned products from contract manufacturing to manufacturing at their own unit. Source of pellets for product at S.No.1 will be M/s Vision Pharma, Islamabad.

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Registration-V Case No.33. Registration Board in its 252th meeting considered the following experts opinions and deferred the following products of M/s. Servier Research and Pharmaceuticals (Pakistan) Limited Lahore for confirmation of approval status of the formulation by regulatory authority of reference countries:- S. Name of Drug(s) with Pack Demande Fee & form No. formulation size d price 1 Natrilam 10mg Tablets 30‘s Rs.72.52/ 20-6-2012 Each tablet contains:- Tablet Rs.8000/- Indapamide SR…..1.5mg 30-04-13 AmlodapineBesilate…..10mg Rs. 130,000/- (Antihypertensive diuretic + Total Fee Rs. 150,000/- Calcium antagonist) Form 5-D 2 Natrilam 5 mg Tablets 30‘s Rs.36.26/ 05-04-2011 Rs.8000/- Each tablet contains:- Tablet 30-04-13 Indapamide SR…..1.5mg Rs. 130,000/- Amlodapineas Total Fee Rs. 150,000/- Besilate…..5mg Form 5-D (Antihypertensive diuretic + Calcium antagonist)

Expert opinion:- Brig. Dr. Sohail Aziz Dr. Asad Riaz Kitchlew Brig® Syed Muzamil Hassan Armed Forces Institute of Head of Department of Najmi, Cardiology, Rawalpindi Cardiology PIMS, Islamabad The drug Natrilam In the light of clinical Natrilam of M/s. Servier is 10mg/1.5mg is recommended evidence and clinical use of combination of Imdapamide for registration in Pakistan. both agents, I would and Amlodipine intended for recommend the registration of use in treatment of Natrilam in Pakistan for hypertension. The combination effective blood pressure seems rational control and its cardiovascular pharmacologically. benefits. Indapamide, a thiazide related diuretic has been shown in clinical tirals to be highly effective for reducing blood pressure in hypertensive patients. It can also help to reduce the pedal edema which is a common side effect of the calcium channel blockers like amlodipine. The later drug has a well-established place in

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treatment of hypertension and the CCBs as a class have been recommended as preferred drugs for hypertension in the JNS guidelines. Since Natrilam is a slow release formulation, it is advisable that dissolution profile and pharmacokinetic data of the formulation may be evaluated before granting registration. Recommended for registration after this requirement.

The firm has provided Copy of Legalized Free Sale Certificate from Country of Origin.

Decision: Registration Board considered the applications for registration and advised the firm to submit scientifically rational laboratory scale stability data as per guidelines approved by the Board in 251st meeting.

Case No.34.

The Registration Board in its 237th meeting acceded to the request of M/s. PDH Labs, Lahore to market Lignocaine 1% Injection previously registered as solvent with their other product “Sonnet Injection (IM) Reg.No.030609 free of cost. The firm has deposited differential fee of Rs. 12000/- for this purpose. The registration board decided as under. “ Request of the firm was acceded subject to the price fixed by PAC and submission of differential fee.” It is submitted the DPC fixed the price of Rs. 5.00/2ml ampoule for “Lignocaine 1% Injection.” It is further submitted that the firm also possess the registration of Lignocaine as free of cost with Sonnet Injection Reg. No. 030609. The status of the products (Sonnet + Lignocaine) is still not clear whether is free of cost or not . Decision: Registration Board accepted request of the firm to fix MRP of lignocain 1% inj for sale in market. The firm is directed to supply the diluent free of cost along with all dry power injectable as per their undertaking on stamp paper.

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Case No.35.

M/s Vega Pharmaceuticals (Pvt.) Ltd; Lahore has requested for change of brand name of their following products:- S. No. Name of Drug(s) Reg. No. New proposed name(s) 1. Vesclor 250mg Capsule 078695 Curacef Each capsule contains:- Aclor Cefaclor monohydrate eq. to Efclor Cefaclor ………………………. 250mg Cefclor Aceflor 2. Vesclor 500mg Capsule 078696 -do- Each capsule contains:- Cefaclor monohydrate eq. to Cefaclor ………………………. 500mg 3. Vesclor 250mg Dry Powder Suspension 078697 -do- Each 5ml after reconstitution contains:- Cefaclor monohydrate eq. to Cefaclor ………………………. 250mg 4. Vesclor 125mg Dry Powder Suspension 078698 -do- Each 5ml after reconstitution contains:- Cefaclor monohydrate eq. to Cefaclor ………………………. 125mg 5. Vegazid 250mg Dry Injection 078703 Curazid Each vial contains:- Cecef Ceftazidime (as pentahydrate) … 250mg Cetoz Cetaz Cefdime Cedime 6. Vegazid 500mg Dry Injection 078704 -do- Each vial contains:- Ceftazidime (as pentahydrate) … 500mg 7. Vegazid 1gm Dry Injection 078705 -do- Each vial contains:- Ceftazidime (as pentahydrate) … 1gm 8. Vegapime 500mg Dry Injection 078706 Curapime Each vial contains:- Cepiem Cefpime Cefepime hydrochloride eq.to Pime Cefepime ……………………… 500mg Pimecef 9. Vegapime 1gm Dry Injection 078707 -do- Each vial contains:- Cefepime hydrochloride eq.to Cefepime ……………………… 1gm

10. Xipodox 40mg Dry Powder Suspension 078766 Curadox

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Each 5ml contains:- Podox Cefpodoxime Proxetil eq. to Cefdox Cefpodoxime …………………. 40mg Podoxin Doxin Doxime 11. Perbactum 1gm Dry Injection 078771 Curabact Each vial contains:- Perbact Cefoperazone as Sodium ……... 500mg Ebact Sulbactum as sodium …………. 500mg Bectum Ceftum Cefbact 12. Perbactum 2gm Dry Injection 078772 -do- Each vial contains:- Cefoperazone as Sodium ……... 1gm Sulbactum as sodium …………. 1gm

The name “Aceflor, Cetaz, Pime, Podox & Ebact” are not similar. The firm has provided following documents:- a. Challan of fee of Rs. 20000/- for each product b. Copy of initial letter of registration & renewal status. c. Undertaking on stamp paper. d. Stock position. e. NOC for CRF clearance.

After scrutiny it was pointed out that the above mentioned brand names was also similar to with already registered brand names. The firm therefore, requested to change the brand names from existing brand names to Generic brand name for each formulation. Decision: Registration Board deferred the request for change of brand name to generic names and advised the firm to submit the proposed artwork of the products for consideration of Registration Board.

Case No.36.

M/s. MediPak Limited, Lahore has requested for registration of following products for export purpose only:- S. No. Name of Product(s) 1. Normal Saline Intravenous Infusion Each 5000ml Contains: Sodium Chloride…….45gm Water for injection…….QS 2. Ringer Lactate Intravenous Infusion Each 5000ml contains:

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Sodium Chloride…….30gm Potassium Chloride……2.0gm Calcium Chloride 2H2 O……1.35gm Sodium Lactate………30.5gm Water for injection…….QS

The firm has submitted the following documents:- a. Fee of Rs. 20000/- for this purpose. b. Form-5. c. Under taking on stamp paper. d. Copy of GMP inspection. e. CRF clearance certificate. f. Export order.

The above said products are not registered in Pakistan. However, the product is available in Saudi Arabia. Decision: The request of the firm is acceded to.

Case No.37. Registration Board in its 250th meeting deferred the following products of M/s. Genesis Pharmaceuticals (Pvt.) Ltd; Lahore for evaluation. S. Name of Drug(s) Reg. No. Initial New proposed Date of No. Manufacturer manufacturer/remarks application at the time of and fee registration 1. Cerixon Injection 0.25gm 012063 M/s Chong M/s. Bio-Labs, 30-06-2015 Each vial contains:- Kun Dong Islamabad. Dy # 386 Ceftriaxone Sodium …. 0.25gm Coporation R&I Seoul, Korea. Rs. 50,000/-- 2. Cerixon Injection 0.50gm 012064 -do- -do- -do- Each vial contains:- Ceftriaxone Sodium …. 0.50gm 3. Cerixon Injection 1gm 012065 -do- -do- -do- Each vial contains:- Ceftriaxone Sodium …. 1gm 4. Camex Capsule 017883 -do- -do- -do-

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Each capsule contains:- Cefadroxil monohydrate …………. 500mg

The management of the firm has submitted following documents for this purpose:- a. Fee of Rs. 50,000/- for each products. b. Copies of initial letters of registration and renewal status. c. Copies of letter from licensing section for manufacturing facility. d. Application dossiers.

The registration dossiers have been evaluated and the firm has requested to cancel the registration from contract manufacturing from import and registered in their name through contract manufacturing by M/s. Bio Labs Islamabad. Decision: Registration Board deferred request of the firm for NOC from the manufacturer abroad.

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Item No.V Cases referred by Biological Drugs Division

Case No.01: 143rd Sitting Appellate Board Order held on 29-7-2015

Appeal No. 03/2014 Appellant: M/s Sanofi-Aventis Pakistan Limited, Karachi Appeal preferred against the decision of : Registration Board Decision Appealed Against: Appeal against decision of Registration board taken in its 242nd meeting wherein the Board did not accede to the request of the appellant for transfer of registration of Thymoglobulin (Reg. No. 069513) from M/s Scitech Health (Pvt) Ltd. Karachi to M/s Sanofi-Aventis.

Date of issuance of the decision: 2nd June, 2014 Appeal received on: 28th July, 2014

Summary of the Case:

M/s Sanofi-Aventis Pakistan Limited, Karachi had applied for transfer of registration of Thymoglobulin (Reg. NO. 069513) from M/s Scitech Health (Pvt) Ltd., Karachi to their own name. The Registration board in its 242nd meeting decided as under:

“The Board noted that there is no provision of change of registration, hence the firm shall apply fresh for new registration as per SOP, the fee already deposited will be considered in the new application. M/s Scitech health (Pvt) Limited, Karachi will submit an application for deregistration of the drug stating the reasons.” The request for transfer of registration was, therefore, not acceded to by the said Board.

Appellant represented by: None. The firm had requested for adjournment as their Lawyer Mr. Abid H. Puri was out of country. Nobody appeared on behalf of the Appellant.

Discussion:-

A. The respondents informed that there is no provision available in rules for transfer of registration. It was admitted that the similar type of transfer of registration cases were allowed to other applicants even after the rejection of the Appellant’s application in the 242nd meeting of Registration Board. However, uniform policy was adopted after 246th meeting of the Registration board for de-registration and grant of new subsequent registration in the same meeting, along with required documents as per prescribed procedure.

B. The Board observed that the:-

i. Uniform practice was not followed by Registration Board.

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ii. Discrimination was observed in the decision.

Decision:-

In light of the above, the Board decided to:-

1. Remand back the case to Registration Board for uniform decision, in line with the current existing procedure adopted by the Registration Board in its 246th meeting for such type of cases.

2. The Registration Board was directed to decide upon the instant case in the forthcoming meeting of the Registration Board. With this the appeal stands disposed off.

The case is placed before the Registration Board for a decision in the pretext status and as all the documents are submitted afresh and fulfil all the required of the documents.

Detail of CoPP is as follows:

National Agency of Medicine and Health France Certificate No.13/07/0366 dated 31-7- 2013, Product License No. 570 281-8 or 34009 570 281 83 dated 16-4-1984 from Genzyme Polycolonal S.A.S, 23 Boulvard chambaud de LA Bruyere, 69007 Lyon France

Decision: Registration Board decided as follows:  Cancellation of Thymoglobulin (Reg. No. 069513) from M/s Scitech Health (Pvt) Ltd. Karachi.  Grant of above registrations of Thymoglobulin (Reg. No. 069513 in favor of M/s. M/s Sanofi-Aventis, Karachi. Chairman, Registration Board will permit issuance of registration letter after comments of Cost & Pricing Division about MRP of the drug, compliance of Import Policy for Finished Drugs and confirmation of storage facility of importer.

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Case No.02: Cases for local manufacturing of Veterinary Biological Drugs.

The following cases of locally manufactured biological drugs are placed before the Registration Board.

Sr.No Name of the Name of Drug and Demanded Priced Date of Manufacturer Composition Application

Bio-Labs, BIO-NDFLU DE-CONTROLLED 29.05.2013 Islamabad ND VIRUSES Plot No 145, (MUKTESWAR) 10 AND 1. Industrial triagle H9N2 VIRUS Kahota Road , Islamabad Grand Pharma GPVAC ND+IB+IBD DE-CONTROLLED 30.09.2014 (pvt), Islamabad COMBINED NEWCASTLE DISEASE, INFECTIOUS BRONCHITIS & 2. INFECTIOUS BURSAL DISEASE VACCINE

Grand Pharma GPVAC CORYZA INJ 30ML, DE-CONTROLLED 30.09.2014 (pvt), Islamabad 300ML, 600ML 3. KILLED INFECTIOUS CORYZA VACCINE

Grand Pharma GPVAC IB PLUS DE-CONTROLLED 30.09.2014 4. (pvt), Islamabad BIVALENT IBV VARIANT VACCINE Grand Pharma GPVAC ORT DE-CONTROLLED 30.09.2014 (pvt), Islamabad KILLED ORT VACCINE 5.

Grand Pharma GPVAC CONJUFLU - ND DE-CONTROLLED 30.09.2014 (pvt), Islamabad LIVE AIVH9+NDV 6. VACCINE

Grand Pharma GPVAC SALMONEL DE-CONTROLLED 30.09.2014 (pvt), Islamabad KILLED FOWL TYPHOID 7. VACCINE

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The above cases need to be evaluated for the purpose of evaluation of manufacturing techniques, vaccines safety, efficacy and quality parameters. It is proposed that the products may be referred to experts for comprehensive evaluation and product specific inspection. Matter is placed before the Board for a decision.

Decision: Registration Board referred the case for product specific inspection by following panel focusing on process, strain status, safety and potency data. 1. Prof. Dr. Khushi Muhammad, UVAS, Lahore. 2. Prof. Dr. Irshad Hussain, UVAS, Lahore 3. Dr Masud-Ur-Rehman DDG (Biological), DRAP.

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Case No.03: Cases for Imported Products of Veterinary Biological Drugs

Name of Manufacturer Name of Drug (s)/ Date of Document Remarks Decision of Sr #. Indenter/ Composition & application ary RB Manufactu Therapeutic / Fee status Details rer Group 1. Ghazi IZO S.P.A IZOVAC ND-FLU Date of Auth No. IZO SPA has Deferred for Brothers Via A. Binachi EMULSIFIED Application 08/2008/V informed that confirmation Karachi. Italy INACTIVATED 15-Jul-08 dated 09- Ghazi of legal status VACCINE AGAINST 6-2008 Brothers is of NEWCASTLE Deposited not their manufacturer DISEASE AND fee AVIAN INFLUENZA Document authorized and importer A 15000+ legalized agent in and me too 35000 as on Each dose of 0.5 ml Pakistan. status 19-3-2015 of vaccine CoPP from

Contains: Italy dated Firm has to Balance Fee i. Inactivated 08-1-2007 update the

Newcastle Disease latest strain Nil of influenza. Virus. 50 PD50 ii. Inactivated whole avian in fluenza virus antigen f H5-N9 subtype strain A/ck/lt/22A/98: HI.=6 Log2 in oil emulsion 2. Marush Laboratories Avisan Multi Date of CoPP No. Me too Approved as (Pvt) Hipra S.A. Each dose application N i.GALLIMU per Import Limited, K- Avda. La contains: 03.08.2010 1765ESP NE 302 Reg Policy for 123, Model Selva Amer - Avian Infectious No.049592 Finished Deposited Town, (Girona) Bronchitis virus, Free Sale Drugs. fee Lahore. Spain. inactivated, strain Certificate ii.LIVONOB Rs.100000/- H52 HAI1 : 26 – 28 YES ILIS Firm will

- Newcastle Disease (IB+ND+ED provide valid Balance Fee Virus Indication S) COPP and inactivated, La Nil s. New iii. ND EDS Chairman, Sota strain Castle IB by IZO RB will ………………….. Disease iv. AV PRO permit HAI2 : 24 – 26 (ND), 303 by issuance of - Egg Drop Infectious LOHMIN registration Syndrome virus Bronchitis v. CEVAC letter. inactivated, (IB), Egg ND IB EDS Adenovirus-127 Drop Reg strain ………... Syndrome No.022799 HAI1 : 27 – 29 (EDS) 1 Mean titre of the haemagglutionation Pack Sizes inhibition after 1000 Ds inoculation of a Vial

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dose of vaccine to 500 Ds SPF chicks Vial 2 Mean titre of the haemagglutionation inhibition after inoculation of a dose of 1/50 vaccine to SPF chicks (Biologicals) (Veterinary use only)

The firm has cold storage facility. 3. Ghazi Brilliant Bio Futvac Date of Indications New Deferred for Brothers Pharma limited application Molecule confirmation Karachi. Hyderabad, 19-Feb-10 of India composition, Deposited indications, fee latest CoPP Rs.50000/- status Balance Fee including

Nil availability in country of origin 4. Mustafa Veyx-Pharma Hypophysin® LA Date of Legalized/ Me too Deferred for Brothers B.V., injectable Solution application notarized needs confirmation Faisalabad. Forellenwegm Each 1ml 26-Mar-10 CoPP No. confirmation of me too SJ contains:- 23-A-2- status, Raamsodonksv Carbetocin…… Deposited 0616/09 indications eer, The 0.07mg fee dated and latest

Netherlands, Chlorobutanolum Rs.100000/- 18.6.2009 CoPP Vexy Pharma hemihydrate…2.00 New CoPP Germany mg Sodium Acetate Balance Fee No. DEGU trihydrate….0.5mg 93 dated th Acetic Acid, Nil 10 July, glacial…..3.0mg 2014 WFI….1,4004.43m Product in g (Minux ‘X’, see on market below) Sod. in Hydroxide....0.8mg exporting (X=20% solution to country. adjust the pH- value) Prod Reg Endogenous No. posterior pituary 3100171- lobe hormone 00-00 Oxytocin dated 19-

12-2003 Minutes for 254th Registration Board Meeting 488

For Veterinary use For animal only. use Pack size 10ml Vial 20ml Vial 50ml Vial 5. ICI Intervet Receptal Injectable Date of CoPP No. New Deferred for Pakistan International Solution Each ml of application 36-1- Molecule confirmation Limited, GmbH, solution for 11-Apr-10 092/14 of Karachi. Unterschleissh injection contains:- dated 12- indications, Deposited eim, Germany. Buserelin acetate 12-2014 CoPP status fee 4.2 micrograms from including BUSERELIN (corresponding to Rs.100000/- Germany availability in ACITATE 0.4 micrograms country of buserelin) Balance Fee Prod Reg origin (Gonadotropin (Gonadotropin- No. -releasing releasing hormone). Nil 2104-00- hormone). (For Veterinary 00, 15-2- Use). 1982

Indications For Cattle (Gonadotr opin- releasing hormone)

Pack Sizes 100ml 50ml

6. Hospital BIOLOGICAL QYH-ND EDS Date of Production Me too status Deferred for Services & CO. LTD., VAC application License not confirmation Sales, Beijing, Each one dose 25-Jun-10 No. 1008 confirmed of me too Karachi. P.R. China. contains:- White (2009) status and mineral oil for Deposited The legalization injection, span, fee GMP documents of submitted Tween-80, Certificate are not documents. Rs.100000/- aluminium stearate, No. 029 verified by

and Allantoic fluids (2008) the Embassy Balance Fee from both NDV DML No. of Pakistan.

infected chicken The case may Nil embryonic eggs and Free Sale be deferred EDSV infected Certificate till duck embryo. The No. verifications. titer of ND Virus in 10082043 > 108.0 EID50/0.1ml before inactivation, those of Egg drop syrdrome virus is Minutes for 254th Registration Board Meeting 489

> 107.0 EID50/0.1ml before inactivation. (For Veterinary Use) 7. Mustafa Vexy Pharma PGF Veyx ® Date of Legalized Approved as Brothers GmbH, Solution for application and per Import Faisalabad. Germany Injection Each 15-Sep-10 Notarized Policy for 1ml contains:- CoPP No. Finished Cloprostenol Deposited 23-A-2- Drugs. Sodium…..0.092m fee 0664/10 Approval is

g(equivalent to Rs.100000/- dated 14- for cattle use 0.0875mg 4-2010 only. Cloprostenol)(Prost Balance Fee DIEU 868 aglandin F2a- dated Firm will agonists) Nil 30.5.2014 provide valid COPP and Indications Chairman, For cattle RB will Scheduling permit of Oestrus issuance of and registration ovulation, letter. Anoestrus, induction of abortion until day 120of gestation, induction of parturition.

Pack Sizes For cattle 0.5ml/Ani mal/ 5.7PGF injection

For Pigs 0.175ml/A nimal/2ml PGF Vial 10ml and 20ml vial

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8. Golden Lohmann AviPro ® 108 FC 3 Date of US DA Documents Deferred for Harvest, Animal PlatinumVaccine application Approved not complete completion of Karachi. HealthInternati Each per dose 22-Mar-11 documents onal, Winslow, (0.25ml) contains:- May be including Maine, United Pasteurella Deposited deferred as CoPP. State of multocida, X-73 fee no response America. strain (Type 15000+ from the 1)……….108.5 85000 experts. CFU Pasteurella Deferred for multocida, P-1662 Balance Fee strain for strain (Type Nil Pakistani 4)….108.5 CFU Market By Pasteurella following multocida, 86-1913 experts strain (Type Prof Dr 3x4)…108.5 CFU Khushi (Inactivated poultry Muhammad vaccine). Prof Dr Masood Rabani Dr Arshad Dr Manzoor (M-240) Deferred for clarification of information sought by committee and review by already constituted committee and veterinary expert of ECBD (M- 241).

Decision of the Board invited for experts.

9. Marush Boreingher Calvenza-03 26-Mar-11 DML No. Deferred for As product is (Pvt) Ingelheim, EIV/EHV 124 strain for USDA Limited, K- USA Each dose contains: Deposited verification approved 123, Model Equine Herpesvirus fee Free Sale by following thus Town, Type 1, strain KyA Certificate experts Registration Lahore. (active ingredient)... 50000 No. Prof Dr Board RP ≥ 1.0*Balance Fee 1500865 Khushi approved as

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Equine Influenza, Muhammad per Import strain Nil Indication Prof Dr. Policy for Newmarket/2/93, s: Masood Finished subtype A2 (active Equine Rabbani Drugs. ingredient) ... ≥ Influenza Dr. Arshad 128 HUH** in Horses Dr. Manzoor Firm will Equine Influenza, (EI) (M-240). provide valid strain Kentucky/95, COPP and subtype A2 (active Pack Sizes Chairman, ingredient)... ≥ 128 RB will HUH** 1dose/2ml permit Equine Influenza, syringe issuance of strain A/Equi- 10 x 1 registration 2/Ohio/03 (active dose/2ml letter. ingredient)... ≥ 128 syring HUH** Carbopol (adjuvant 0.5%)…… 20 ± 5% Ethylene diamine tetra acetic acid (chelating agent 14%)….. 0.134%*** Thimerosal (preservative 2.… 0.1 – 0.2% Gentamicin (preservative, residual amount from medium)…. ≤ 30µg/mL Sodium chloride solution (adjust antigen concentration 0.85%) …qs to 2mL ...... *RP= Relative Potency when compared to a standard reference vaccine by in vitro test **HAU= Hemagglutination units ***Quantity of chelating agent is by calculation (Biologicals)

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The firm has cold storage facility.

10. Marush Boreingher Elite 9 HS Date of DML No. New As product is (Pvt) Ingelheim, Each dose contains: application 124 Molecule. USDA Limited, K- USA Active Ingredients 26-Mar-11 approved

123, Model Bovine Deposited Free Sale thus Town, Rhinotracheitis fee Certificate Registration Lahore. Virus (IBR)… Rs.50000/- No. Board ….min 1.58 x 10 8 1402128 approved as or 10 8.2 virus Balance Fee per Import particles Indications Policy for Bovine Virus Nil : For Finished Diarrhea Virus Cattles Drugs. (BVD) ……min 1.27 x 10 7 or 10 Bovine Firm will 7.1 virus particles Rhino provide valid Myxovirus Tracheitis COPP and parainfluenza3 (IBR), Chairman, (PI3)…… min 1.00 Bovine RB will x 10 8 or 10 8.0 Diarrhea permit virus particles Virus issuance of Bovine respiratory (BVD), registration syncytial virus Parainflue letter. (BRSV)... .min 1.58 nza 3 x 10 6 or 106.2 (PL3), virus particles Bovine Haemophilus Respirator somnus P51… .min y Syncytial 3.1 x 10 8 Virus organisms (BRSV). Haempphilus somnus, Oklahoma…… min Pack Size 3.1 x 10 8 organisms 10 Ds- Leptospira 50ml canicola…… min 50 Ds- 1.0 x 109 organisms 250ml Leptospira grippotyphosa…mi n 7.0 x 10 8 organisms Leptospira hardjo……min 7.0 x 10 8 organisms Leptospira icterohaemorrhagia e..min 1.0 x 10 9 organisms

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Leptospira
yndro… min 7.0 x 10 8 organisms Non-active Ingredients Potassium aluminium (10%)… .max. 125 µl Thiomersal (merthiolate)…ax. 84 µl Neomycin … .max. 42 µl Physiological saline… .Qsf – as necessary (Biologicals)

The firm has cold storage facility.

11. Marush Laboratorios Avisan Secure 31-Mar-11 DML No. Me too Approved as (Pvt) Hipra S.A. Each dose contains: N 1720 confirmed per Import Limited, K- Avda. La - Inactivated Deposited ESP dated Policy for 123, Model Selva Amer Salmonella fee 25-1-2007 i. Finished Town, (Girona) Enteritidis LAYERMU Drugs. Lahore. Spain. PT4……….…. 100000 Indication NE SE Reg MAT ≥ 1/13* Balance Fee s: No.020126 Firm will - Inactivated For by provide valid Salmonella Nil Poultry BIOMUNE. COPP and Typhimurium Chairman, DT104..…. MAT ≥ Salmonella RB will 1/40* ……….. Enteritidis permit * Title obtained by (SE), issuance of Microagglutination Salmonella registration technique on plates Typhimuri letter. after um (ST). inoculation of the vaccine in SPF Pack Size chicks. (Biologicals) 1000 Ds Vial The firm has cold storage facility.

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12. Vet. KBNP, Inc. Himmvac Fowl Pox 16-Apr-11 CoPP No. Me too. Deferred for Pharma Dugok-ri, Vaccine Each dose 6-268 Document clarification Trading Sinam, Yesan, contains:- Deposited dated 2nd are not valid regarding Company, Chungnam. Fowl Pox virus fee July, 2010 and out strain details New Steel Korea. 2775 strain…30% dated. with local Market, (at least 102.0 15000 compatibility, Near EID50) Balance Fee May be completion of Regent (Biological Product deferred for documents, Cinema, Vaccine). 85000 Fee balance fee G.T. Road, (For Veterinary confirmation and me too Gujranwala Use). and status - Pakistan./ completion of documents. 13. Mustafa Federal State Formol Vaccine 28-May-11 Free sale May be Deferred for Brothers Unitary Against certificate deferred for confirmation Faisalabad. Enterprise Pasteurellosis of Deposited from Fee of remaining “Stavropol Cattle And Buffalos fee Russia confirmation fee and valid Biofactory” Semi-Liquid, provided. and documents. Russia. Aluminium 15000 documents Moreover, Hydroxise Balance Fee GMP- are out dated. authentic Composition in de/15/001/ English complete 85000 08 version of -active constituent DATED documents of Pasteurella 13-2-2008. will be multocida (serotype GMP provided by B), The certificate the firm. concentration of issued by microbiological German cells in the vaccine and must be not less Bulgarian than 6 authorities. Milliard/cm3; Certificate -phosphate- buffer from suspension is Russia aluminum provided hydroxide as which is sorbent 7.5%; legalized -in-activant and formalin-practically notarized is not revealed. but due to (Immunity Russian Biological language, preparation the vaccines). certificate can not be assessed.

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14. Mustafa Federal State Flu Proket H5 28-May-11 CoPP No. May be Deferred for Brothers Unitary Vaccine Against 08/2010/B deferred for confirmation Faisalabad. Enterprise Birds Influenza Deposited G Fee of remaining “Stavropol Inactivated fee Dated 15- confirmation fee and valid Biofactory” Emulsified Flu 2-2010. and documents. Russia. Protekt H5 15000 documents Moreover, Composition in Balance Fee GMP No. are outdated. authentic complete DE/15/001 English (Immunity 85000 /2008 version of Biological Dated 13- documents preparations. 2-2008 will be Homogeneous provided by water emulsion of the firm. ethe white or white- pink color). 15. Vety-Care Cahic Lanzhou FMD Bivalent 23-Jul-11 CoPP No. Company is Deferred for (Pvt) Ltd., Bio- Vaccine (FMDV not interested written Rawalpindi. Pharmaceutica Virus type O & Deposited DML No. clarification l, China. Asia I) Each 0.2ml fee May be from the firm contains:- Free Sale deferred for Not less than 107.0 15000+ Certificate withdrawal of LD50 in 0.2ml 50000 their solution Balance Fee Indications application or (Vaccine) otherwise. (For Veterinary 35000 Use). 16. Hilton PT. MEDION Medivac Pox Date of GMP No. Me too status Approved as Pharma JI. Raya Vaccine application 085-GMP- confirmed per Import (Pvt) Ltd., Batujajar Each dose of 8-Feb-11 2011 Policy for Karachi. Cimareme, vaccine contains:- Deposited Validity up i.HIPRA Finished Kabupaten Live attenuated fee to 23-8- POX Drugs Bangdung, fowl pox virus of 15000+ 2016 By Marush Indonesia. M-92 strain at least 35000+ Prod Reg from HIPRA Firm will 103 EID50 50000 No. Germany. provide valid (Freeze dried live D.0311168 COPP and vaccine against Balance Fee 0 VTS.1 Chairman, infectious RB will Nil Laryngotracheitis License permit (ILT) in poultry No. issuance of (broilers, roosters, 085/MFJ/ registration layers and HK.340/F. letter. breeders). 5/08/11 (For Veterinary Free Sale Use). Certificate 23068/HK. 340/F/04/2 013 Valid up to April, 2018

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17. Hilton PT. MEDION Medivac ILT Date of GMP No. Me too status Approved as Pharma JI. Raya Vaccine application 085-GMP- confirmed per Import (Pvt) Ltd., Batujajar Each dose of 8-Feb-11 2011 Policy for Karachi. Cimareme, vaccine contains:- Validity up i. LT 1 VAX Finished Kabupaten Live attenuated Deposited to 23-8- By ICI Drugs Bangdung, Infectious fee 2016 Pakistan Indonesia. Laryngotracheitis 15000+ Prod Reg Firm will virus of A 96 strain 35000+ No. provide valid at least 102.5 50000 04031700 COPP and EID50 (Freeze VKS.1 Chairman,

dried live vaccine Balance Fee License RB will

against infectious Nil No. permit Laryngotracheitis 085/MFJ/ issuance of (ILT) in poultry HK.340/F. registration (broilers, roosters, 5/08/11 letter. layers and breeders). Free Sale (For Veterinary Certificate Use). 23068/HK. 340/F/04/2 013 Valid up to April, 2018

18. Vety-Care Intervet Nobilis SG 9R Date of CoPP No. ECBD Deferred for (Pvt) Ltd., International Vacccine Each dose application VD/ 0317- Recommende clarification Rawalpindi. B.V. Wim de 0.2ml contains:- 18-Oct-11 465743 d (M-240) regarding Korverstraat, Salmonella BD 2011- non- AN Boxmeer, Gallinarum strain Deposited 236491 Deferred for availability of Netherland. 9R in fee dated 24- clarification product in stabilizer………at 15000+ 5-2011 about country of least 2x107 CFU 85000 Prod Reg justification origin. (Live vaccine). No. of live strain Balance Fee 324- (241) BVEAK The product is not Nil Chief available in the Veterinary country of origin. Officer, Netherland .

19. Vety-Care Intervet Innovax-Nd Date of USDA No. ECBD Keeping in (Pvt) Ltd., International, Vaccine Each dose application 286 Recommende view Rawalpindi. USA. contains:- 18-Oct-11 dated 18- d (M-240) approval by Live Turkey Herpes 7-2007 Deferred for USDA, Virus strain Deposited clarification Registration HVT/NDV- fee about Board F>……at least 15000+ Indication serotype of approved the 1810 PFU per bird 85000 strain NDV-F product as

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dose. Balance Fee Marix and review per Import (Live virus disease by already Policy for vaccine) Nil cerotype 3 constituted Finished live vector committee Drugs. and Firm will The product is veterinary provide valid available in the expert of COPP and country of origin. ECBD. (M- Chairman, 241) RB will May be permit deferred issuance of completion of registration documents. letter

20. Snam Bioveta a.s. Ornibur Date of CoPP No. Deferred for Approved as Pharma, Komenskeho Intermediate Plus, application 073/2011 strain for per Import Lahore. / 212, 683, 23 Lyophilizate for the 31-Oct-11 dated 15- syndrome Policy for Ivanovice na preparation of Deposited 8-2011 referred to Finished Hane, Czech suspension for fee following Drugs Republic. domestic fowl Each Rs.100000/- Prod experts one dose contains:- License Prof Dr Firm will Virus bursitidis Balance Fee No. 97- Khushi provide valid avium, strain IBDV 055-09-C Muhammad COPP and OP-1, min. 104.0 Nil dated 16- Prof Dr Chairman, TCID50- 4-2009 Masood RB will max.105.2 TCID Rabani permit 50 (Vaccine). GMP Dr Arshad issuance of Certificate Dr Manzoor registration No. 167- (M-240) letter. 2012- Defered for CGMP testing of extraneous Manufactu pathogens by ring NVL at the authorizati cost of on No. applicant. 389/2011/ (M-241) RHV dated The report of 07-5-2012 NVL is attached on Free Sale the last page Certificate of Agenda. Yes As per report “The sample submitted and referred above complies the test requirement

Minutes for 254th Registration Board Meeting 498

s” 21. Marush Laboratorios HipraBovis-4 Date of CoPP No. New Deferred for (Pvt) Hipra S.A. Each dose contains: application N 2772 Molecule confirmation Limited, K- Avda. La - Inactivated 26-Nov-11 ESP of approval 123, Model Selva Amer Infectious Bovine Deposited DATED status of Town, (Girona) Rhinotracheitis fee 09-4-2013 formulation Lahore. Spain. Virus (IBR), 15000+ Indications by reference strain LA 35000 : regulatory ………………….. For Cattle authorities. ≥ 107 TCID50 Balance Fee - Inactivated Bovine Parainflenza-3 Nil Rhinotrach Virus (PI-3), starin eitis Virus SF4... ≥ 480 HAU (IBR), - Inactivated Bovine Bovine Diarrhoea Respirator Virus (BVD), y Syncitial Strain NADL Virus ……..….. ≥ 106 (BRSV), TCID50 Parainflue Freeze-dried nza 3(PI3) fraction: - Live Bovine Respiratory Pack Size Syncitial Virus, Strain LYM P56 30 Ds Vial ……..….. ≥ 104 TCID50 (Biologicals) 22. Ghazi Kofavet BIOTECTOR S1 W Date CoPP No. Document Deferred for Brothers Special Inc BACTERIOPHAG ofapplicatio A000/GP- are outdated confirmation Karachi. Korea E….1.0X10PFU n old dated and fee of strain, 15-Dec-11 25-12- confirmation approval 2009 May be status by Deposited deferred reference fee regulatory 15000+ authorities, 35000 remaining fee Balance Fee and 50000 documents 23. Ghazi Kofavet BIOTECTOR S1 15-Dec-11 Reg No. New Deferred for Brothers Special Inc BACTERIOPHAG CCBMZ00 Molecule confirmation Karachi. Korea E Deposited 04 of strain, fee DATED 5- May be approval 15000 8-2010 deferred for status by Balance Fee document are reference outdated and regulatory 35000 fee authorities, confirmation remaining fee and

Minutes for 254th Registration Board Meeting 499

documents

24. Saadat Laboratoire Nemovac Vaccine 18-Apr-12 CoPP No. Me too Approved as Internationa Porte Des Each dose of CCLYUN confirmed per Import l, Lahore. Alpes, Saint vaccine contains:- Deposited 2.05.11 10 Policy for Priest, France. Attenuated Swollen fee Certificate i.Izovac SHS Finished Head Syndrome no 10125 Live by IZO Drugs virus, PL21 strain, 100000 Dated 26- at least 102.3 Balance Fee 4-2011 II.Hipra Firm will CCID50 Free sale VIAR SHS provide valid (Biological Nil certificate by Marush COPP, Products). confirming Strain PL21 confirmation sale in confirmation of storage France. required. facility and Chairman, RB will permit issuance of registration letter

25. Marush Ceva Cevac Corymune 4 23-Apr-12 Certificate Me too Deferred for (Pvt) Phylaxia K Injectable Deposited of Origin confirmed clarification Limited, K- Biological Co. Contains:- fee and Free regarding 123, Model Ltd., Budapest, -Avibacterium Sale No. i.HEMOVA non- Town, Hungary. paragallinarum 100000 X Reg availibility of Lahore. Serotype A….Min. Balance Fee MA- No.011485 product in 7 Log10 CFU HU/06V/2 by Marial country of before inactivation. Nil 006 origin / -Avibacterium /M21 ii. IZOVAC manufacture paragallinarum Coryza by Serotype B….Min. Indications IZO 7 Log10 CFU : iii. before inactivation. For MULTIMUN -Avibacterium Poultry E ABC Reg paragallinarum No.035030 Serotype C….Min. Avian by 7 Log10 CFU Coryza BIOMUNE before inactivation. (AB&C), -Salmonella Salmonella Enteritidis Enteritidis. (SE)……induce min 5 log2 MAT Pack Sizes (Biological) 1000Ds The firm has cold Vial storage facility. 5 x 1000 Ds Vials 3000 Ds Vials

Minutes for 254th Registration Board Meeting 500

5 x 3000 Ds Vials

26. Marush Phylaxia Cevac Corymune 7 23-Apr-12 Certificate Me too status Deferred for (Pvt) Biological Co. K Injectable of Origin Confirmed clarification Limited, K- Ltd., Budapest, Contains:- Deposited and Free regarding 123, Model Hungary -Newcastle Disease fee Sale No. i. IZOVAC non- Town, (ND) virus, strain MA- ND EDS hg3 availibility of Lahore. “SZ” 100000 HU/06V/2 by IZO product in Lasota…..induced Balance Fee 006 ii. country of min.6 log2 HI with /M21 LAYERMU origin / 1 dose or min.4 Nil NE 3 Reg. manufacture log2 HI with 1/50 Indications No. 020125 dose or min..50 . by PD50 For BIOMUNE -Infectious Poultry Bronchitis (IB) virus, “M- Newcastle 41”…..induce Disease min….6 log2 HI (ND), -Egg Drop Infectious Syndrome, 76 Bronchitis (EDS) virus, strain (IB), Egg “B8/78”….induce Drop min.7 log2 HI Syndrome -Avibacterium (EDS), paragallinarum Avian Serotype A….Min. Coryza 7 Log10 CFU (AB&C). before inactivation. Solmonella -Avibacterium Enteritidis paragallinarum (SE) Serotype B….Min. 7 Log10 CFU before inactivation. Pack Sizes -Avibacterium paragallinarum 1000 Ds Serotype C….Min. Vial

7 Log10 CFU 5 x 1000 before inactivation. Ds Vials -Salmonella 3000 Ds Enteritidis Vial (SE)……induce min 5 log2 MAT 5 x 3000 (Biological) Ds Vials

The firm has cold storage facility.

Minutes for 254th Registration Board Meeting 501

27. Marush CEVA- Cevac Ibird 17-May-12 Certificate New Deferred for (Pvt) PHYLAXIA Each dose contains: of Origin Molecule confirmation Limited, K- vetneriary 1.1 Active Deposited and Free of 123, Model Biologicals substance fee Sale No. formulation Town, Co.Ltd Avian infectious MA- in reference Lahore. Hungary bronchitis virus, 50000 HU/06V/2 drug variant strain 1/96 Balance Fee 006 regulatory at least 2.8 log 10 /M21 authorities as EID50 Ph. Eur. Nil per decision 0442 Free Sale in 249th RB 1.2 Virus protecting Certificate meeting components of the No. excipients 3378/1- Gelatine max. 10µg 4/13 Ph. Eur. 0330 Hydroxypropylbeta Indications dex max. 100µg Ph. . Eur. 1804 For Sucrose max. Poultry 200µg Ph. Eur. Use 0204 (Biologicals) Infectious Bronchitis (IB) Variants

Pack Sizes

1000 Ds Vial 2500 Ds Vial 5000 Ds Vial 8000 Ds Vial

28. Marush Laboratorios Toxipra S7 Date of CoPP No. New Deferred for (Pvt) Hipra S.A. Each dose contains: application N 2770 Molecule confirmation Limited, K- Avda. La β toxoid of 6-Aug-12 ESP of 123, Model Selva Amer Clostridium formulation Town, (Girona) perfringens type B, Deposited Prod in reference Lahore. Spain. C and D …> 10 UI fee License drug antitoxine β/ml of 15000+ No. regulatory serum 35000 2770ESP authorities as ε toxoid of Balance Fee Dated 09- per decision Clostridium 4-2013 in 249th RB perfringens type B, Nil meeting C and D ….> 5 GMP No. Uiantitoxine ε/ml of Pack Sizes ES/030/14 serum Dated 04-

Minutes for 254th Registration Board Meeting 502

α toxoid of Sheep & 3-2014 Clostridium novyi goats : Free Sale type B 2ml/ adult Certificate …………………..> animals. No. 3.5 UI antitoxine 1ml / Dated 04- α/ml of serum Young 12-2014 α toxoid of animals. Indications Clostridium . septicum Claves: ….……………… 2ml / For Cattle, …..> 2.5 UI animals Sheep & antitoxine α/ml of Goat. serum Adults Anaculture of 4ml/ Clostridiu Clostridium animals m chauvoei infections ...... 100% caused by protection in guinea CL pig Perfringen Anaculture of s (BCD), Clostridium CL sordellii Septicum, ...... 100 CL % protection in Chauvoei, guinea pig CL (Biologicals) Sordellii

29. Marush Laboratorios Hipraviar – 27-Jun-12 CoPP No. Confirmed Approved as (Pvt) Hipra S.A. Clon/H120 N 2275 Me too status per Import Limited, K- Avda. La Injectable Each per Deposited ESP Dated Policy for 123, Model Selva Amer dose (0.03ml) fee 04-12- i. NOBILIS Finished Town, (Girona) ocular- nasal route) 2014 ma5 +Clone Drugs Lahore. Spain. contains:- 100000 30 by MSE Live Newcastle Balance Fee Indications Firm will Disease Virus, . ii. IZOVAC provide valid CL/79 Nil For CHB by IZO COPP and clon…….> 106.5 Poultry Chairman, EID50 Live Use RB will Infectious permit Bronchitis Virus, Newcastle issuance of strain H- Disease registration 120…….>103 (ND letter EID50 Clone), (Biologicals). Infectious Bronchitis The firm has cold (IB). storage facility. Pack Sizes 1000 Ds Vial 2500 Ds

Minutes for 254th Registration Board Meeting 503

Vial

30. Marush Laboratorios Hipraviar ILT Date of CoPP No. Me too Approved as (Pvt) Hipra S.A. Each dose contains: application N 2237 Confirmed per Import Limited, K- Avda. La Live Avian 28-Jun-12 ESP Policy for 123, Model Selva Amer Infectious DATED i. NOBILIS Finished Town, (Girona) Spain Laryngotracheitis Deposited 16-2-2011 ILT by MSD Drugs. Lahore. Virus, strain CHP fee 50 … > 103 – 103.5 DML No. ii. IZOVAC Firm will EID50 100000 ILT by IZO provide valid (Biologicals) Balance Fee Free Sale COPP and Hipraviar ILT Certificate iii. CEVAC Chairman, Each dose contains: Nil Dated 04- LTL Reg No. RB will Live Avian 12-2014 022791 by permit Infectious Selva issuance of Laryngotracheitis Indications registration Virus, strain CHP . For iv.VECTOR letter 50 … > 103 – 103.5 Poultry MUNE FP EID50 Use. LT Reg No. (Biologicals) Avian 039931 by Infectious BIOMUNE The firm has cold Laryngotra storage facility. cheitis Virus (ILT) Pack Size 1000 Ds Vial

31. Marush CEVA- Vectormune HVT Date of Free Sale Reply Keeping in (Pvt) Biomune AIV Injectable Application Certificate view Limited, K- Veterinary Each dose 29-Jun-12 No. Deferred for approval 123, Model Biologicals contains:- 1500379 clarification status of the Town, Company, HVT/AIV virus in Deposited regarding product by Lahore. Lenexa, KS CP#1…50- 90% fee DML No. technical USDA, USA. Cryoprotectant 368 details about Registration #2……10-50% Rs.50000/- transportation Board (Biologicals). Balance Fee and the approved as Indications composition per of Import Nil . For and review Policy for Poultry by already Finished Pack Sizes Use. constituted Drugs. committee 1000 Ds and Firm will Ampule + It is veterinary provide valid 2000 ml transported expert of COPP and diluent in special ECBD.(M- Chairman, containers 241) RB will

Minutes for 254th Registration Board Meeting 504

2000 Ds fill with permit Ampule + Liquid issuance of 400ml Nitrogen registration diluent Gas letter

4000 Ds Avian Ampule + Influenza – 800 ml H5 (Bird diluent Flue)

The firm has cold storage facility 32. Vet. KBNP, Inc. Himmvac Dalguban Date of Legalized/ Documents Deferred for Pharma Dugok-ri, SG9R Live Vaccine application notarized are outdated confirmation Trading Sinam, Yesan, Each dose 19-Jul-12 CoPP, of remaining Company, Chungnam, contains:- Prod. Reg May be fee, me too New Steel Korea. Salmonella Deposited No.6-136 Deferred. status and Market, gallinarum 9R fee dated 3- legalized Near strain……..at least 15000 12-1986 authentic Regent 2x107 CFU/dose Balance Fee documents Cinema, (Poultry Vaccine CoPP No G.T. Road, for fowl typhoid). 85000 100906 Gujranwala dated 18- - Pakistan. 10-2010

33. Hilton PT. MEDION Medivac ND- 2-Sep-12 GMP No. Confirmed Approved Pharma JI. Raya Gumboro Emulsion 085-GMP- Me too status subject to (Pvt) Ltd., Batujajar Vaccine Deposited 2011 compliance Karachi. Cimareme, Each dose (0.5ml) fee Validity up i. IZO VAC of Import Kabupaten of vaccine to 23-8- ND IBD by Policy for Bangdung, contains:- 50000 2016 Ghazi Finished Indonesia. Inactivated Balance Fee Brothers Drugs and Newcastle disease Prod Reg from IZO confirmation virus of LaSota Nil No. England of storage strain at least 50 D.0911374 facility of PD50 4VTC ii. HYPRA importer. Inactivated GUMBORO Firm will infectious bursal License BPL 2. By provide valid disease virus of No. Marush from COPP and Winterfield 2512 085/MFJ/ HYPRA Chairman, strain at least 800 HK.340/F. Germany. RB will serum 5/08/11 permit neutralization (SN). issuance of (Freeze dried live Free Sale registration vaccine against Certificate letter infectious 23068/HK. Laryngotracheitis 340/F/04/2 (ILT) in poultry 013 Valid (broilers, roosters, up to Minutes for 254th Registration Board Meeting 505

layers and April, breeders). 2018 (For Veterinary Use).

34. Vet. KBNP, INC, Himmvac ND Oil 10-Sep-12 CoPP No. Documents Deferred for Pharma Dugok-ri, Vaccine Each vial not confirmation Trading Sinam, Yesan, contains:- Deposited DML No. completed of me too Company, Chungnam, Inactivated ND fee may be status, New Steel Korea virus (B1)…..30% Free Sale deferred. indications Market, (At least 108.8 15000+ Certificate and legalized Near EID50/dose) 35000+ authentic Regent (Biological 65000 Indications documents Cinema, Products). G.T. Road, (For Veterinary Balance Fee Gujranwala Use). - Pakistan./ Nil

35. Ghazi IZO S.p.A., Izovac CHB 7-Oct-12 CoPP No. May be Deferred for Brothers Via A. Bianchi Multidose Freeze- deferred due confirmation Karachi. 9, Brescia, Dried Bottle Deposited DML No. to incomplete of me too Italy. Each dose of fee documents. status, vaccine contains:- Free Sale indications, Live attenuated 15000 Certificate legalized Newcastle Disease Balance Fee authentic Virus Strain Indications documents Clone…..106 35000 and legal EID50 status of Live Attenuated manufacturer Infectious and importer Bronchitis Strain Massachusetts H120……103EID5 0 Live Attenuated Infectious Bronchitis Strain 28/86…..103EID50 (Immunological) 36. Marush CEVA- Circomune W Oral 10-Jul-12 CoPP No. Application Registration (Pvt) Biomune Each dose of is withdrawn Board Limited, K- Veterinary vaccine contains:- Deposited DML No. by the acceded 123, Model Biologicals Chickem Anemia fee company firm’s request Town, Company, Virus…at > Free Sale for Lahore. Lenexa, KS ……106.2 100000 Certificate May be withdrawal of USA. TCID50/dose Balance Fee withdrawn application. (Biologicals). Indications Nil

Minutes for 254th Registration Board Meeting 506

37. Marush CEVA- Circomune 10-Jul-12 Manufact USDA Approved as (Pvt) Biomune Injectable uring Approved. per of Import Limited, K- Veterinary Each dose of Deposited License Policy for 123, Model Biologicals vaccine contains:- fee No. 368 Me too status Finished Town, Company, Chicken Anemia 15000 + Dated 23- Confirmed Drugs. Lahore. Lenexa, KS Virus……at 60000 12-1988 USA. >…..104.9 (Nov. i. NIBULIS Firm will TCID50/dose 2010)+ Free Sale CE by MST provide valid Glycerol………… 25000 Certificate ii. AVIPRO COPP and ……………2 0% No. THYMOVA Chairman, 20% Bvlue Dye Balance Fee 1402568 C by RB will Solution…….1% LOWMAN permit (Biologicals). Nil Indications issuance of . For registration Poultry letter Use

Disease. Chicken Anemia Virus (CAV)

Pack Sizes

1000Ds Vial 2000Ds Vial

38. ICI Intervet Revalor XS Implant Date of CoPP No. New Deferred for Pakistan GesmbH, Each implant (10 application LCN Molecule clarification Limited, Siemensstrabe pellets contains:- 12-Dec-12 480.912- from the Karachi. 107, A 1210 Trenbolone 0020 applicant Wien Austria acetate……..200mg Deposited (Austria) regarding 17 β- fee Dated 26- availability of Estradiol….40mg. 11-2010 the product in For Veterinary 50000 country of Use). Balance Fee Prod Reg origin. No. 141- Nil 269 (USA) Dated 19- 1-2007 CoPP indicates the product is not in the country of origin.

Minutes for 254th Registration Board Meeting 507

39. ICI Intervet Inc. Fortegra Vaccine 12-Oct-12 DML No. New Keeping in Pakistan Corner of (Coccidiosis 165A Molecule view Limited, Delaware Vaccine Live Deposited Dated 10- approval Karachi. Avenue and Oocysts) fee 2-2011 status of the Monroe Street The amount of product by Millsboro, antigenic material 100000 Free Sale USDA, Delaware per dose in the final Balance Fee Certificate Registration 19966 USA. container :- No. Board Minimum of Nil 1102354 approved as sporulated oocysts Dated 09- per Import throughout dating 8-2011 Policy for Eimeria USDA Finished acervulina….600 approved. Drugs and Eimeria maxima Free sale confirmation …...200 Eimeria in the of storage maxima MFP USA. facility. …………………… Legalized .100 Notarized Firm will Eimeria certificate provide valid mivati……400 of COPP and Eimeria Licensing Chairman, tenella…….200 and RB will (For Veterinary Inspection permit Use). issued. issuance of registration letter 40. ICI Schering- COVEXIN 10 12-Oct-12 Prod Reg New Deferred for Pakistan Ploug Animal Clostridium No. A9028 Molecule confirmation Limited, Health Vaccine for Sheef Deposited Dated 23- of Karachi. Limited. Beef and Diary. fee 5-2011 formulation Newzealand in reference 50000 GMP No drug Balance Fee NZ262V/2 regulatory 010 Dated authorities as Nil 23-3-2011 per decision Free sale in 249th RB certificate meeting confirms product is freely sold in New Zealand Notarized and legalized document indicating the product is registered in different

Minutes for 254th Registration Board Meeting 508

countries including UK.

41. Hi-Tech Pfizer Animal Poulvac ® ST 29-Oct-12 U.S. Me too Approved as Pharmaceut Health (Pfizer Vaccine Veterinary confirmed per Import icals, Inc), 2000 Illustration of a Deposited License Policy for Lahore. Rockford 0.005ml dose fee No. 190 Finished Road, Charles contains:- Drugs and City, Iova, Bacterial Culture…. 100000 Certificate confirmation USA. ≥3.0 x 107 Balance Fee No. of storage CFU/Dose at 1302587 facility of release Nil importer. LP Indications Stabilizer…0.00125 Firm will ml Sterile Salmonella provide valid PBS…..0.00125ml COPP and For Veterinary Chairman, Use). RB will permit issuance of registration letter 42. Mustafa Federal Dry Live vaccine 6-Dec-12 Prod Reg Deferred for Deferred for Brothers Governmental against Newcastle No. strain for confirmation Faisalabad. Budgetary disease from strain Deposited 104779629
yndrome
of remaining Institution La Sota. fee 6437 dated Market By fee, me too “Federal Contains:- 11-8-2011. following status and Centre for One intranasal 15000 experts legalized Animal (ocular) dose of the Balance Fee DML No. Prof Dr authentic Health” (FGBI vaccine contains at 0011-1- Khushi documents. “ARRIAH”, least 6.7 1g 85000 001221 Muhammad Moreover, Vladimir, EID50/head of ND dated 11- Prof Dr authentic Russia. vaccine strain 8-2011. Masood English (strain La Sota) Rabani version of (Vaccine). Dr Arshad documents Dr Manzoor will be (M-240) provided by Deffered for the firm. clarification of strain and review by already constituted committee and veterninary experts ofECBD.(M- 241)

Minutes for 254th Registration Board Meeting 509

May be deferred due to documents not completed. 43. Mustafa Federal Virus Vaccine 12-Jun-12 Prod Reg May be Deferred for Brothers Governmental against infectious No. deferred due confirmation Faisalabad. Budgetary bursal disease from Deposited 104779629 to documents of remaining Institution BG strain fee 6437 dated not fee, me too “Federal Contains:- 11-8-2011 completed. status and Centre for Infectivity of the 15000 legalized Animal virus vaccine shall Balance Fee authentic Health” (FGBI be at least 104.5 DML documents. “ARRIAH”, EID50/cm3 One 85000 No.00-11- Moreover, Vladimir, dose of the vaccine 1-001221 authentic Russia. shall contain 103 dated 11- English EID 50 8-2011 version of (Vaccine). documents will be provided by the firm. 44. Mustafa Federal Vaccine against 12-Jun-12 Prod Reg May be Deferred for Brothers Governmental infectious chicken No. deferred due confirmation Faisalabad. Budgetary bronchitis from Deposited 1023/3012 to documents of remaining Institution strain “H-120” dry fee 83720 not fee, me too “Federal live Dated 26- completed. status and Centre for Contains:- 15000 7-2011 legalized Animal One immunizing Balance Fee authentic Health” (FGBI vaccine dose GMP No. documents. “ARRIAH”, contains not less 85000 104779629 Moreover, Vladimir, than 104 EID50 of 6437 authentic Russia. IB virus (Strain H- Dated 26- English 120) (Vaccine). 12-2011 version of documents will be provided by the firm. 45. Mustafa Federal Associated Vaccine 12-Jun-12 DML No. May be Deferred for Brothers Governmental Against Newcastle 00-11-1- deferred due confirmation Faisalabad. Budgetary Disease Deposited 001220 to documents of remaining Institution Infectious Chicken fee Dated 11- not fee, me too “Federal Bronchitis and egg 8-2011. completed. status and Centre for drop
yndrome-76 15000 legalized Animal inactivated Balance Fee Free Sale authentic Health” (FGBI emulsion Certificate documents. “ARRIAH”, 85000 No. N4- Moreover, Vladimir, 4056 authentic Russia. Dated 11- English 10-2011 version of documents will be Minutes for 254th Registration Board Meeting 510

provided by the firm. 46. Mustafa Federal Virus vaccine 12-Jun-12 Prod Reg May be Deferred for Brothers Governmental against Winterfield No. deferred due confirmation Faisalabad. Budgetary Disease 2512 strain Deposited 102330128 to documents of remaining Institution (Missing) fee 3720 not fee, me too “Federal Dated 26- completed. status and Centre for 15000 7-2011 legalized Animal Balance Fee authentic Health” (FGBI GMP No. documents. “ARRIAH”, 85000 0011-1- Moreover, Vladimir, 001221 authentic Russia. 26-12- English 2011 version of documents Free Sale will be Certificate provided by No. 4-4078 the firm.

Case No.04: Cases for Imported Products of Human Biological Drugs Originating From SRA Countries.

S.# Name of Manufacture Name of Date of Documentar Remarks Decision of . Indenter/ r Drug (s)/ application / y Details RB Manufactu Composition Fee status rer & Therapeutic Group 1. Novartis Vetter XOLAIR Date of CoPP No. EMA Keeping in Pharma Pharma 75MG Application 02/15/84060 CPP,GMP view (Pakistan) Fertigun Prefilled 09.02.2015 Dated 16-1- Certificate. approval Limited, ng Gmbh & Syringes 2015 status of Karachi./ Co. KG Omalizumab Deposited fee the product Langenarg. Prod Reg No by EMA, Germany. Demanded 50000+ EU/1/05/319/ Registratio MRP (50000 005/010 n Board 35000/- Dated 28-10- Dated 10-2- approved 2015) 2009 as per Balance Fee Import Indications Policy for Nil Finished Treatment of Drugs and Chornic confirmatio Spontaneous n of storage Urticaria facility of

Minutes for 254th Registration Board Meeting 511

(CSU) importer.

2. Merixil Sigma-Tau ONCASPAR Date of CoPP No. New Keeping in Pharma, Arzneimittel 3750 IU application S 225-1- Molecule view Pakistan, GmbH Injection 22-12-2014 03/15 dated approval Islamabad Liebherrstr. Each Vial 29-7-2015 EMA status of (Dy No. 2556 22 contains 5ml:- CPP,GMP the product (R&I) DRAP 80538 1ml of Prod Reg No. CERTIFIC by EMA, Dated 22-12- Munich, solution for 30204.00.00, ATE. Registratio 2014) Germany injection dated n Board Deposited fee contains 750 07.11.1994 approved IU of PEGL- 50000 as per

ASPARGINA Balance Fee Import SE (ANTI- Policy for CANCER) Nil Finished Drugs and Demanded confirmatio MRP n of storage 285600/Vial facility of importer. 3. Lilly LILLY Basaglar Date of CoPP No. Bio Keeping in Pakistan, France, Each Pen application 05/15/89895 Similar, view Karachi. 67640 contains….. 09.02.2015 Dated 16-7- EMA approval Fegersheim, Insulin 2015 approved status of France Glargine 100 Deposited fee Prod Reg No. the product units/ml (3ml EU/1/14/944/ by EMA, Kwikpen) 100000 005-008 & Registratio Pack size of Balance Fee 010-013 n Board 5’s per pack dated 09-9- approved Demanded Nil 2014 as per price Rs. Import 4400/ pack of Policy for 5 Finished (For type-II Drugs and diabetes) confirmatio n of storage facility of importer. 4. Novartis Novartis Cosentyx Date of CoPP No. EU,EMA Keeping in Pharma Pharma 150mg Vial , application 01/15/84304 CPP,GMP view (Pakistan) Switzerland. Powder for 11.02.2015 Dated 28-1- CERTIFIC approval Limited, solution fro 2015 ATE. status of Karachi./ injection Deposited fee New the product 50000 Prod Reg No. Molecule. by EMA, Composition: Balance Fee EU/1/14/980/ Registratio Each vial Nil 001 n Board contains Dated 15-1- approved Secukinumab 2015 as per 150mg Import Indications. Policy for

Minutes for 254th Registration Board Meeting 512

Demanded Finished MRP75000/- Treatment of Drugs and moderate-to- confirmatio severe plaque n of storage psoriasis facility of importer. 5. Novartis Novartis Cosentyx 11.02.2015 EU,EMA Keeping in Pharma Pharma 150mg CoPP No. CPP,GMP view (Pakistan) Switzerland. Pre-filled Deposited fee 01/15/84317 CERTIFIC approval Limited, syringe Dated 28-1- ATE. status of Karachi./ 50000 2015 New the product Composition: Balance Fee Molecule. by EMA, Each prefilled Prod Reg No. Registratio syring Nil EU/1/14/980/ n Board contains 002-005 approved Secukinumab Dated 15-1- as per 150mg 2015 Import Policy for Demanded Indications. Finished MRP 75000/- Drugs and Treatment of confirmatio moderate-to- n of storage severe plaque facility of psoriasis importer.

6. Lilly Lilly Basaglar Date of CoPP No. Bio Keeping in Pakistan, France,67640 Each cartridge application 05/15/89859 Similar, view Karachi. Fegersheim, contains 23.02.2015 Dated 16-7- EMA approval France Insulin 2015 approved. status of Glargine…… Deposited fee Prod Reg No. the product 100 units/ml EU/1/14/944/ by EMA, (Cartridge 100000 001-004 & Registratio 3ml) Balance Fee 009 n Board Pack size of 5- Dated 09-9- approved Cartridges Nil 2014 as per (For type-II Import diabetes) Policy for Demanded Finished price Rs. Drugs and 4400/pack of confirmatio 5 n of storage facility of importer. 7. Elli Lilly ELLI LILLY Trulicity Date of CoPP No. New Keeping in Pakistan, and Company Each Pen application 10-0124- Molecule view Karachi. Indianapolis, contains:- 05.03.2015 2015/22/PK FDA approval IN 46285 Dulaglutide…. Issuace date Approved status of USA . Deposited fee 11-12-2014 Free Sale the product 0.75mg/0.5ml Expiry date in USA by US license Single Dose 50000 11/12/2016 USFDA No. 1891 Pen Balance Fee Export from Registratio Minutes for 254th Registration Board Meeting 513

Lilly USA. USA n Board (Long acting Nil approved analogue of Prod Reg No. as per Glucagon like 125469 Import peptide) Dated 18-9- Policy for Pack size of 2014 Finished 4’s Drugs and Demanded confirmatio price n of storage Rs.19000/pack facility of of 4’s importer. Anti-diabetic for Type-II diabetes 8. Elli Lilly ELLI LILLY Trulicity Date of CoPP No. New Keeping in Pakistan, and Company Each Pen application 10-0115- Molecule view Karachi. Indianapolis, contains:- 05.03.2015 2015-18-PK FDA approval IN 46285 Dulaglutide…. Issuance date Approved status of USA . Deposited fee 11-4-2014 Free Sale the product 01.5mg/0.5ml in USA by Single Dose 50000 USFDA US license Pen Balance Fee Prod Reg No. Registratio No. 1891 Pack size of 125469 n Board 4’s Nil Dated approved Demanded 18/9/2004 as per price Import Rs.19000/pack Policy for of 4’s Finished (Long acting Drugs and analogue of confirmatio Glucagon like n of storage peptide) facility of Anti-diabetic importer. for Type-II diabetes 9. OBS Merck Sharp ROTATEQ Date of CoPP No. USFDA Keeping in Pharma & Dohme Oral Solution application CT 0862-14 Approved view (Pvt) Ltd., Corp, US, 2ml I 20.03.2015 WHO dated approval Karachi. / Sumneytown Rotavirus 01-7-2014 status of Pike, West Vaccine,Live, Deposited fee Me too the product Point, PA Oral 100000 Prod License by USA. Pentavalant No. STN USFDA 1 Single Dose Balance Fee 125122 dated Registratio Tube. 03-2-2006 n Board Nil approved Composition Major as per Each dose Indication. Import (2ml) contains Rota virus Policy for rotavirus induced Finished type* : gastroenteriti Drugs and s. confirmatio Minutes for 254th Registration Board Meeting 514

G1 ------not n of storage less than 2.2 x facility of 106 IU1 importer.

G2 ------not less than 2.8 x 106 IU1

G3 ------not less than 2.2 x 106 IU1

G4 ------not less than 2.0 x 106 IU1

PIA [8] ------not less than 2.3 x 106 IU1

Demanded MRP Rs. 3,488/- 10. Sanofi- Genzyme MYOZYME 9/6/2015 CoPP No. New Deferred aventis Ireland Ltd (ALGLUCOS Molecule, for Pakistan IDA IDASE Deposited fee DML No. Compositio complete Limited, Industrial ALFA) n information Karachi. Park Old Genzyme 100000 Free Sale Confirmati regarding Kilmeaden Flanders bvba Balance Fee Certificate on CoPP, free Road Cipalstraat 8 sale status, Waterford, Nil Indications compositio Ireland. n, Imported indications Countary etc. (United Kingdom)

11. Sanofi- SHAN – 5 03.06.2015 CoPP No. Re- Deferred aventis Diptheria, confirmatio for Pakistan Tetanus, Deposited fee DML No. n from the complete Limited, Bivalent company information Karachi. Pertussis, 100000 Free Sale as similar regarding Hepititus B Balance Fee Certificate name manufactur and products er, CoPP, Haemophilus Nil Indications are already free sale Influenzae approved. status, Type b compositio Conjugate n, Vaccine indications (adsorbed) etc.

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12. Genesis Stichting Aragam 50mg CoPP No. Documents Deferred Pharmaceuti Sanquin Solution for confirmatio for cals (Pvt) Bloedvoorzie Infusion Deposited fee DML No. n complete Ltd, Lahore ning Human information Cantt./ Plesmanlaan, Normal 15000 Free Sale regarding Amsterdam, Immunoglobul Certificate CoPP, free The in……..50mg/ Balance Fee sale status, Netherlands. ml Indications compositio Marketing Check fee n, Authorization indications Holder:- etc. Oxbridge Pharma Ltd. United Kingdom.

13. Amtul CP D-Clot No Data CoPP No. Documents Deferred Pharmaceuti Pharmaceutic Heparin confirmatio for cals, als Ltd. Sodium Date of DML No. n complete Lahore. / Wrexham Injection 5000 application information . Industrial IU/5ml Vial Free Sale regarding Estate, Ash Each 5ml Deposited fee Certificate CoPP, free Road North, contains:- sale status, Wrexham, Heparin Balance Fee Indications compositio United Sodium…… n, Kingdom ….5000 iu indications (Heparin etc. /Anticoagulant ). 14. Sanofi- Sanofi Vivaxim*- No Data CoPP No. Recommen Deferred aventis Pasteur, SA, Suspension ded by for Pakistan Lyon, France. and Solution Date of DML No. ECBD. RB complete Limited, for injection in application Deferred information Karachi. a Prefilled Free Sale for expert regarding dual-chamber Deposited fee Certificate opinion of CoPP, free syringe Each Gen ® sale status, dose of Balance Fee Indications Karamat compositio reconstituted Gen ® n, vaccine (1ml) Tasawarn indications contains:- Birg ® etc. Vi capsular Najmi. polysaccharid Prof Umar es of Salmonella typhi (Ty2 strain)…….25 micrograms) Hepatitis A virus, GBM strain* Minutes for 254th Registration Board Meeting 516

(inactivated** )…….160 units*** (Bacterial and Viral Vaccine)

15. Novity SuperGeneric C-Vaxin No Data CoPP No. The board Deferred Pharma s, Inc. Injection deferred for Distributors, Phoenix, AZ, Each injection DML No. these cases complete Lahore./ USA. contains:- Date of and information Hepatist C application Free Sale advised to regarding Vaccine……. Certificate get CoPP, free 50mcg Deposited fee clarificatio sale status, (…………….. Indications n/ compositio ) Balance Fee justificatio n, n from the indications applicant etc. about sources of API, product, details and statements on company’s website. Complete confirmaio n of documents needed. 16. FK Pharma LFB Vialebex No Data CoPP No. General Deferred Lahore. Biomedicame Injection Each Decision for nts vial contains:- DML No. complete Courtabouef Serum Human Date of information Cedex, Albumin application Free Sale regarding France 20%...... Certificate CoPP, free 100ml Deposited fee sale status, (Biological Indications compositio Blood Check n, Fractions). Balance Fee indications etc.

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17. FK Pharma Exporter Immunoplex- No Data CoPP No. The board Deferred Lahore. Avenir N Sublingual after for Pharma and Tablets Date of DML No. discussion complete Manufactured Each tablets application decided to information : contains:- Free Sale refer back regarding Labtech Interferon Deposited fee Certificate to ECBD CoPP, free Pharma S.A. alpha for re- sale status, Geneva, 2b………… Indications evaluation compositio Switzerland. ….200 i.u Check and n, (Anti-viral). Balance Fee preparation indications of detailed etc. report for considerati on of Registratio n Board. 18. Martin Dow Laboratorio Calco 100IU No Data CoPP No. 04th ECBD Deferred Pharmaceuti Italiano Ampoule Each Deferred for cals Biochimico ampoule Date of DML No. for complete Limited, Farmaceutico contains: - application confirmatio information Karachi. S.P.A Italy Salmon Free Sale n of regarding Calcitonin Deposited fee Certificate documents CoPP, free …100IU sale status, (Calcium Indications compositio Regulatory) Check n, Balance Fee indications etc. 19. Sanofi- Sanofi INSUMAN Date of CoPP No. Deferred aventis Pasteur, SA, COMB 30 application for Pakistan Lyon, France. 100IU/ML DML No. complete Limited, SUSP Deposited fee information Karachi. SUSPENSIO Free Sale regarding N FOR 100000 Certificate CoPP, free INJECTION sale status, Balance Fee Indications compositio n, Nil indications etc. 20. Sanofi- Sanofi INSUMAN Date of CoPP No. Deferred aventis Pasteur, SA, COMB 25 application for Pakistan Lyon, France. 100IU/ML DML No. complete Limited, SUSPENSIO Deposited fee information Karachi. N FOR Free Sale regarding INJECTION 15000 Certificate CoPP, free sale status, Check Indications compositio Balance Fee n, indications etc.

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21. Sanofi- Sanofi INSUMAN Date of CoPP No. Deferred aventis Pasteur, SA, BASAL application for Pakistan Lyon, France 100IU/ML DML No. complete Limited, SUSPENSIO Deposited fee information Karachi. N FOR Free Sale regarding INJECTION 15000 Certificate CoPP, free sale status, Check Indications compositio Balance Fee n, indications etc. 22. GlaxoSmith GlaxoSmithK NIMENRIX Date of CoPP No. Product Deferred Kline line VACCIN application compositio for Pakistan Biologicals, MENINGOC DML No. n complete Limited, S.A. Belgium OCCAL Deposited fee confirmatio information Karachi. Free Sale n regarding 50000 Certificate CoPP, free sale status, Check Balance Indications compositio Fee n, indications etc. 23. GlaxoSmith GlaxoSmithK POLIORIX Date of CoPP No. Status Deferred Kline line VACCINE application confirmatio for Pakistan Biologicals, 40D DML No. n from the complete Limited, S.A. ANTIGEN Deposited fee company information Karachi. Belgium. UNITS OF Free Sale regarding TYPE 1 15000 Certificate CoPP, free (MAHONEY) sale status, , 8D Check Balance Indications compositio ANTIGEN Fee n, UNITS OF indications TYPE 2 etc. (MEF-1) AND 32D (SAUKETT) 24. Roche F. Hoffman – Kadcyla Vial 09.06.2015 CoPP No. EMA Deferred Pakistan La Roche Each vial APPROVE for Limited, 37- Ltd, Basel contains:- DML No. D, New complete C, Block 6, Switzerland Trastuzumab Deposited fee Molecule, information PECHS, Emtansine Free Sale Strength regarding Karachi/ (Powder)…...1 50000 Certificate reconfirmat CoPP, free 00mg ion,,, two sale status, 20mg/ml after Balance Fee Indications products compositio reconstitution n, Breast cancer Nil indications (Anti-cancer) etc.

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25. Roche F. Hoffman – Kadcyla Vial 09.06.2015 CoPP No. EMA Deferred Pakistan La Roche Each vial APPROVE for Limited, 37- Ltd, Basel contains:- DML No. D, New complete C, Block 6, Switzerland Trastuzumab Deposited fee Molecule, information PECHS, Emtansine Free Sale Strength regarding Karachi/ (Powder)…...1 50000 Certificate reconfirmat CoPP, free 00mg ion,,, two sale status, 20mg/ml after Balance Fee Indications products compositio reconstitution n, Breast cancer Nil indications (Anti-cancer) etc. 26. Ali Gohar Patheon UK Jetrea solution Date of EMA CoPP EMA Keeping in & Co, Ltd, for Injection application No. APPROVE view Karachi Kingfisher Each vial 01/13/64125 D, New approval Drive contains:- 10.06.2013 dated 11-4- Molecule status of Covin Gham Ocriplasmin… 2013 the product Swindon .0.5mg/ 0.2ml by EMA Wiltshire Uk For Deposited fee Prod Reg No. Registratio Vitreomacular J-605613 n Board traction 50000 dated 19-4- approved (rDNA ) 2013 subject to Balance Fee compliance Demanded Indications: of Import MRP Nil Treatment of Policy for 600000/- optic macular Finished holes Drugs and Shelf life 18 confirmatio Months. n of storage facility of importer. 27. Novartis Novartis Cosentyx Date of CoPP No. EU,EMA Deferred Pharma Pharma 150mg application 01/15/84316 CPP,GMP for (Pakistan) Switzerland. Pre-filled Pen 11.02.2015 Dated 28-1- CERTIFIC complete Limited, 2015 ATE. information Karachi./ Ne regarding Prod Reg No. Molecule. compositio Deposited fee EU/1/14/980/ n of 002-005 product. 50000 Dated 15-1- Balance Fee 2015 Nil Indications Treatment of moderate-to- severe plaque psoriasis

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28. Acumen BBT Biotech DICLAIR HP- CoPP No Deposited fee Deferred Pharmaceuti GmbH HCG 5000IU 00000109-07- 100000/- for ca, Arnold- INJ HUMAN 14 dated 09-7- complete Rawalpindi Sommerfeld- MENOPAUS 2014 information ring 28 52499 AL regarding Baeswiler GONADADO compositio Germany PTROPIN 75 n, free sale IU status and HUMAN me too status. 29. Acumen BBT Biotech DICLAIR HP- CoPP No Deposited fee Deferred Pharmaceuti GmbH FSH 5000IU 00000209-07- 100000/- for ca, Arnold- INJ PURE 14 dated 09-7- complete Rawalpindi Sommerfeld- FOLLICLE 2014 information ring 28 52499 STIMULATI regarding Baeswiler NG compositio Germany HORMONE n, free sale 75 IU status and me too status. 30. Acumen BBT Biotech DICLAIR HP- CoPP No Deposited fee Deferred Pharmaceuti GmbH HMG 00001023-12- 100000/- for ca, Arnold- INJ HUMAN 14 dated 23- complete Rawalpindi Sommerfeld- MENOPAUS 12-2014 information ring 28 52499 AL regarding Baeswiler GONADADO compositio Germany PTROPIN 75 n, free sale IU status and HUMAN me too status.

Case No.05: Cases for Imported Products of Human Biological Drugs originating from Non- SRA Countries.

In 246th meeting of Registration Board, basic parameter of import of biologicals for further processing in Pakistan were decided to cope up with the International requirements and requirement set forth by DRAP Act 2012. The issue of biosimilarity is still remaining to be finalized for finished import. At a time, RB is implementing stringent rules for local manufacturing but there is a no stringent policy at par with local manufacturer and as envisaged in the DRAP Act 2012. There is a need to frame policy guideline for the finished import in biological which are originating from non SRA Countries. DRB may also consider the requirement of the country, as the majority of the population cannot afford the branded products of high price, which are beyond their purchasing power.

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CASES OF BIOLOGICAL DRUGS ORIGINATING FROM NON- SRA COUNTRIES

S.No. Name of Manufact Name of Drug Date of Fee. Rs. Balance Documents Indenter/ urer (s)/ appl. Fee. details/ Importer Composition & Remarks Therapeutic Group 1. Ghazi Vaccine TYVIVAC 08.01.2010 15000+ 50000 Me Too Brothers Company VACCINE 35000 Karachi. of Dalat Each vial Pasteur conatins:- Vietnam. Each 0.5ml dose contains……0.0 25mg Purified Vi Capsular Polysaccharide (Typhoid vaccine) 2. Hilton Shanghai Brelet Powder 12.11.2010 15000+3 50000 NEW Pharma CP for Injection 5000 MOLECUL (Pvt) Ltd., GuoJiang Each vial E Karachi. Pharmace contains:- utical Recombinant Co.Ltd. Human Tumor Shanghai, Necrosis Factor- China a Receptor II :IgGFc (rhTNFR:Fc) Fusion Protein….25mg 3. CCL Shenzhen EPO Injection 30.11.2010 15000 50000 ME TOO Pharmace Xinpeng 4000 IU Each ml +35000 uticals Biotech contains:- Firms (Pvt) Ltd., Co. Ltd., Recombinant stance is Lahore. Shenzhen, Human required China. Erythropoietin… fee is 4000 IU only (Chinese 50000 Pharmacopoeia, Edition 2005, Volume III) (Recombinant Human Erythropoietin) (For Human Use)

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4. CCL Shenzhen EPO Injection 30.11.2010 15000 50000 ME TOO Pharmace Xinpeng 10000 IU Each +35000 uticals Biotech ml contains:- Firms (Pvt) Ltd., Co. Ltd., Recombinant stance is Lahore. Shenzhen, Human required China Erythropoietin… fee is 10000 IU only (Chinese 50000 Pharmacopoeia, Edition 2005, Volume III) (Recombinant Human Erythropoietin). (For Human Use) 5. Macter Dr. Reditux TM 02.02.2011 15000 0 Ristova by Internatio Reddy’s Injection 100mg (02-2- Roche, nal (Pvt) Laboratori Each 10ml vial 2011)+ Recommedn Limited, es Ltd., contains :- 85000 ed in 48th Karachi. Ranga Rituximab (r- (09-10- ECBD + Reddy DNA 2011) Biosimilarit District, origin)...... y +PICS Hyderaba 100mg Total. d, India. (Antineoplastic 100000/ Monoclonal - Antibody). (For Human Use) 6. Macter Dr. Reditux TM 02.02.2011 15000+8 0 Ristova by Internatio Reddy’s Injection 500mg 5000 Roche, nal (Pvt) Laboratori Each 50ml vial Recommedn Limited, es Ltd., contains :- ed in 48th Karachi. Ranga Rituximab (r- ECBD + Reddy DNA Biosimilarit District, origin)...... y +PICS Hyderaba … 500mg d, India (Antineoplastic Monoclonal Antibody). (For Human Use)

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7. Ghazali Kotra Vaxcell Heparin 03.03.2011 15000+3 0 Me Brothers, Pharma Sodium Injection 5000+50 Too+(24.8.2 Karachi. (M) Sdn 5000 i.u./ml 000 015) Bhd. Each vial Cheng contains:- Industrial Heparin Sodium Estate, (bovine Melaka, mucosa)……250 Malaysia. 00 I.U/5ml (Anti- Coagulant). (For Human Use) 8. CCL Shanghai Genheal 26.03.2011 15000 50000 Me too Pharmace United Injection +35000 uticals Cell Each vial (4.0 Firms (Pvt) Ltd., Biotechno IU) contains:- stance is Lahore. logy Co., Recombinant required Ltd., Human Growth fee is Pudong, Hormone…1.6m only Shanghai, g 50000 P.R. (Growth China Hormones). (For Human Use) 9. A.A. Shenyang EPIAO 4000IU 29.03.2011 15000+3 Pharma, Sunshine PFS 5000+50 Karachi Pharmace ERYTHROPOIE 000 utical Co TIN 4000IU Ltd 3,A1, Road 10, Econ & Tech Developm ent Zone, Shenyang, China. 10. A.A. Shenyang EPIAO 10000IU 29.03.2011 15000+3 Pharma, Sunshine PFS 5000+50 Karachi Pharmace ERYTHROPOIE 000 utical Co TIN 10000IU Ltd 3,A1, Road 10, Econ &

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Tech Developm ent Zone, Shenyang, China 11. Sind Bharat Regen-D 60 Gel 16.10.2011 15000 FEE Medical Biotech for Topical Each Stores, Internatio gram contains:- Karachi. nal Purified bulk of Limited, rh-Epidermal Hyderaba Growth Facctor d, Andhra Gel……………1 Pradesh, 50ug India. (Recombinant Human Epidermal Growth Gel for Topical). 12. Sind Bharat Regen-D 150 16.10.2011 15000 FEE Medical Biotech Gel for Topical Stores, Internatio Each gram Karachi. nal contains:- Limited, Purified bulk of Hyderaba rh-Epidermal d, Andhra Growth Facctor Pradesh, Gel……………6 India. 0ug (Recombinant Human Epidermal Growth Gel for Topical). 13. Trans- Egyptian Epifasi 5000 I.U. 02.11.2011 15000 85000 Me Too Continent Internatio Lyophilized al Pharma nal Ampoules for (Pvt) Ltd., Pharmace injection Peshawar. utical Each ampoule Industries contains:- Company, Human Egypt. Chorionic Gonadotrophin …5000IU (Polypeptide Hormone).

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14. Trans- Egyptian Epigonal 75 IU 02.11.2011 02.11.20 85000 Me Too Continent Internatio Lyophilized 11 al Pharma nal Ampoules for (Pvt) Ltd., Pharmace injection Each Peshawar. utical ampoule Industries contains:- Company, Human Egypt Menoupausal Gonadotrophin ……..75 IU (Polypeptide Hormone). 15. Aster M/s Repoitin 2000 Date of Fee 50000 Me Too Life Serum IU/0.5ml application deposite Sciences, Institute Solution for 20-12-2011 d 15000 CoPP No. New of India, Injection dated WHO- Garden Ltd, Each 0.5ml pre- 20-12- GMP- Town, 212/2, filled syringe 2011+ CERT/PD/E Lahore/ Hedapser, contains:- 35000 X134 Dated Pune, Erythropoietin dated 23-9-2011 India. Concentrated 04-11- valid until Solution Ph. 2013+ 24-3-2012 Eur…2000 IU (Biopharmaceuti Prod cal/Erythropoies License No. is stimulating 10 (in form agent Anatomic 28-D) dated agent) 20-11-2009.

Free Sale Certificate No.Drugs/M fg/FSC/221 4/2010/1 Dated 21-9- 2010

GMP No. Mfg/Drugs/ GMP/27/20 11/Z-1 Dated 23-3- 2011

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16. Aster Serum Repoitin 4000 Date of Fee 50000 Me Too Life Institute IU/0.4ml application deposite Sciences, of India, Solution for 20.12.2011 d 15000 CoPP No. New Pune, Injection dated WHO- Garden India. Each 0.4ml pre- 20-12- GMP- Town, filled syringe 2011+ CERT/PD/E Lahore/ contains:- 35000 X134 Dated Erythropoietin dated 23-9-2011 Concentrated 04-11- valid until Solution Ph. 2013+ 24-3-2012 Eur…4000 IU (Biopharmaceuti Prod cal/Erythropoies License No. is stimulating 10 (in form agent Anatomic 28-D) dated agent) 20-11-2009

Free Sale Certificate No.Drugs/M fg/FSC/71/2 011/Z-1 Dated 02-9- 2011

GMP No. Mfg/Drugs/ GMP/27/20 11/Z-1 Dated 23-3- 2011

17. Aster Serum Repoitin 10000 Date of Fee 50000 Me Too Life Institute IU/0.4ml application deposite Sciences, of India, Solution for 20.12.2011 d 15000 CoPP No. New Pune, Injection dated WHO- Garden India. Each 1.0ml pre- 20-12- GMP- Town, filled syringe 2011+ CERT/PD/E Lahore/ contains:- 35000 X134 Dated Erythropoietin dated 23-9-2011 Concentrated 04-11- valid up to Solution Ph. 2013+ 24-3-2012 Eur…10000 IU (Biopharmaceuti Prod cal/Erythropoies License No. is stimulating 10 (in form

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agent Anatomic 28-D) dated agent) 20-11-2009

Free Sale Certificate No.Drugs/M fg/FSC/71/2 011/Z-1 Dated 02-9- 2011

GMP No. Mfg/Drugs/ GMP/27/20 11/Z-1 Dated 23-3- 2011

18. A.A. Sunshine TPIAO® 15000 09.04.2012 15000+3 Pharma, Pharmace U Solution for 5000+50 Karachi utical Co. Injection 000 Ltd., Each vial China contains:- Recombinant Human Thrombopoietin …15000U (Recombinant protein drug) 19. Getz Gan & Basagine 20.06.2012 15000+8 Me Too Pharma, Lee Solution for 5000 03.09.2015 Karachi Pharmace Injection uticals, 100Units/ml No.8, Each ml Jingsheng contains; - North 3rd Recombinant Street, Insulin Golden Glargine…..100 Bridge Units / ml Science (Antidiabetic) Industrial Base, Tongzhou District Beijing,C hina.

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20. Sind Quangang Quansheng Date of Fee 0 Me Too Medical Pharmace Solution for application deposite Stores, utical Co., Injection. 21.06.2012 d Karachi. Ltd., Each 1ml vial China contains:- Pack Size 15000+ Recombinant 01 Vial x 85000 Human 75mcg Granulocyte Colony- stimulating Factor (rhG- CSF) 75mcg. (Stimulator of leucopoiesis / Anabolics & haemotpoietic drugs) 21. Sind Quangang Quansheng Date of Fee 0 Me Too Medical Pharmace Solution for application deposite Stores, utical Co., Injection. d Karachi. Ltd., Each 1ml vial 21.06.2012 15000+ China. contains:- 85000 Recombinant Pack Size Human Granulocyte 01 vial x Colony- 300mcg stimulating Factor (rhG- CSF) 150mcg. (Stimulator of leucopoiesis / Anabolics & haemotpoietic drugs) 22. Sind Quangang Quansheng Date of Fee 0 Me Too Medical Pharmace Solution for application deposite Stores, utical Co., Injection. d Karachi. Ltd., Each 1ml vial 21.06.2012 China. contains:- 15000+ Recombinant Pack Size 85000 Human Granulocyte 01 Vial x Colony- 300mcg stimulating Factor (rhG- CSF) 300mcg.

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(Stimulator of leucopoiesis / Anabolics & haemotpoietic drugs) 23. Sind Shandong Quanqi Date of Fee 0 Me Too Medical Quangang Lyophilized application deposite Stores, Pharmace Powder for d Karachi. utical Co., Injection. 21.06.2012 Ltd., Each vial 15000+ China. contains:- Pack Size 85000 Recombinant Human 01 Vial x Interleukin-2 (I) 0.2MIU 0.2MIU. (Stimulator of leucopoiesis / Anabolics & haemotpoietic drugs) 24. Sind Shandong Quanqi Date of Fee 0 Me Too Medical Quangang Lyophilized application deposite Stores, Pharmace Powder for 21.06.2012 d Karachi. utical Co., Injection. 15000+ Ltd., Each vial Pack Size 85000 China. contains:- Recombinant 01 Vial x Human 0.5MIU Interleukin-2 (I) 0.5MIU. (Stimulator of leucopoiesis / Anabolics & haemotpoietic drugs) 25. Sind Quangang Quanqi Date of Fee 0 Medical Pharmace Lyophilized application deposite Stores, utical Co., Powder for d Karachi. Ltd., Injection. 21.06.2012 15000+ China. Each vial 85000 contains:- Pack Size Recombinant Human 01 Vial x Interleukin-2 (I) 1.0MIU 1.0MIU. (Stimulator of

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leucopoiesis / Anabolics & haemotpoietic drugs)

26. Sind Shandong Quanqi Date of Fee 0 Me Too Medical Quangang Lyophilized application deposite Stores, Pharmace Powder for d Karachi. utical Co., Injection. 21.06.2012 15000+ Ltd., Each vial 85000 China. contains:- Pack Size Recombinant Human 01 Vial x Interleukin-2 (I) 2MIU 2.0MIU. (Stimulator of leucopoiesis / Anabolics & haemotpoietic drugs) 27. Aster CSPC PEGLEUKIM Date of Fee Nil New Life Baike 3MG/ML application deposite Molecule Sciences, (Shandong PEGYLATED 24.08.2012 d 15000 New )Bio RECOMBINAN dated CoPP No. Garden Pharmacet T HUMAN 24-8- CN Town, ical Co. GRANULOCYT 2012+ 20120416 Lahore/ Ltd E 35000 Dated 16-4- Manufactu dated 2012 ring Site: 04-11- 212 Jinbu 2013 Avenue, GMP No. South Total Rs CN2012002 Koreas 50000/- 7 Dated 09- Industrial confirm 3-2012 valid Park, ed until 08-3- Qinshi 2017 Muping District, DML No. Yantai LU2010000 City, 7 Dated 01- Shandong 1-2011 Pro. China.

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28. Aster CSPC PEGLEUKIM Date of Fee Nil New Life Baike 6MG/ML application deposite Molecule Sciences, (Shandong PEGYLATED 24.08.2012 d 15000 New )Bio RECOMBINAN dated CoPP No. Garden Pharmacet T HUMAN 24-8- CN Town, ical Co. GRANULOCYT 2012+ 20120416 Lahore/ Ltd E 35000 Dated 16-4- Manufactu dated 2012 ring Site: 04-11- 212 Jinbu 2013 GMP No. Avenue, CN2013055 South Total Rs 0 Dated 30- Koreas 50000/- 12-2013 Industrial confirm valid until Park, ed 29-12-2018 Qinshi Muping Free Sale District, Certificate Yantai No. 2012- City, 044 Dated Shandong 19-4-2012 Pro. China. DML No. LU2010000 7 Dated 01- 1-2011 29. Gudia Virchow Vipeg Injection 30.08.2012 100000 0 Me Too Corporati Biotech 80 mcg Each vial on, Pvt. Ltd, contains:- Peg Karachi/ Survey interferon alfa- No.172 2b……..80mcg (part), (For Human Gagillapur Use) Village, Qutubulla pur, Rangaredd y District Hyderaba d, Andhra Pradesh, India.

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30. Gudia Virchow Vipeg Injection 30.08.2012 100000 0 Me Too Corporati Biotech 100 mcg Each on, Pvt. Ltd, vial contains:- Karachi/ Survey Peg interferon No.172 alfa- (part), 2b……..100mcg Gagillapur (For Human Village, Use) Qutubulla pur, Rangaredd y District Hyderaba d, Andhra Pradesh, India. 31. Gudia Virchow Vipeg Injection 30.08.2012 100000 0 Me Too Corporati Biotech 120 mcg Each on, Pvt. Ltd, vial contains:- Karachi/ Survey Peg interferon No.172 alfa- (part), 2b……..120mcg Gagillapur (For Human Village, Use) Qutubulla pur, Rangaredd y District Hyderaba d, Andhra Pradesh, India. 32. Gudia Virchow Vipeg Injection 30.08.2012 100000 0 Me Too Corporati Biotech 150 mcg Each on, Pvt. Ltd, vial contains:- Karachi/ Survey Peg interferon No.172 alfa- (part), 2b……..150mcg Gagillapur (For Human Village, Use) Qutubulla pur, Rangaredd y District Hyderaba d, Andhra

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Pradesh, India.

33. Gudia Virchow Healace 0.01% 30.08.2012 100000 0 New Corporati Biotech Gel Molecule on, Pvt. Ltd, Each 1gm of Gel Karachi/ Survey contains:- No.172 Recombinant (part), Human Platelet Gagillapur Derived Growth Village, Factor- Qutubulla BB……..100mc pur, g Rangaredd (For Human y District Use) Hyderaba d, Andhra Pradesh, India. 34. Martin Nanogen Nanokine Pre- 30.08.2012 15000+ Dow Bio filled syringe 35000+ Pharmace Pharmace 4000 IU. 50000 uticals utical, Each Pre-Filled Limited, Zone 1- Syringe of 0.5ml Karachi. 5/C, Sai solution Gon Hi contains:- Tech Park, Recombinant Tang Humen Nhon Phu Erythropoietin A Ward, Alfa…………..4 Dist 9, 000 IU HCMC (For Human Vietnam Use) 35. Martin Nanogen Ficocyte Pre- 31.08.2012 15000+ 0 Dow Bio filled syringe 30 35000+ Pharmace Pharmace MU 50000 uticals utical, Each Pre-Filled Limited, Zone 1- Syringe of 0.5ml Karachi. 5/C, Sai solution Gon Hi contains:- Tech Park, Filgrastim (G- Tang CSF) Nhon Phu ………….30

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A Ward, MU Dist 9, (For Human HCMC Use) Vietnam.

36. Gudia Virchow Vipeg Injection 12.09.2012 15000 Me Too Corporati Biotech 50 mcg Each vial on, Pvt. Ltd, contains:- Peg Karachi/ Survey interferon alfa- No.172 2b……..50mcg (part), (For Human Gagillapur Use) Village, Qutubulla pur, Rangaredd y District Hyderaba d, Andhra Pradesh, India. 37. Aster Beijing Consensus – 02.10.2012 15000+ New Life Shuanglu Asteron alpha 9 35000 Molecule Sciences, Pharmace mcg Injection New utical Co. Each Vial Garden Ltd., contains:- Town, No.9, Recombinant Lahore/ Zhongyua Consensus n Road, Interferon Badachu alpha… 9 mcg Hitech (For Human Park, Use) Beijing China. 38. Aster Beijing Consensus – 02.10.2012 15000+ 0 New Life Shuanglu Asteron alpha 15 35000 Molecule Sciences, Pharmace mcg Injection New utical Co. Each Vial Garden Ltd., contains:- Town, No.9, Recombinant Lahore/ Zhongyua Consensus n Road, Interferon Badachu alpha…. 15 mcg Hitech (For Human Minutes for 254th Registration Board Meeting 535

Park, Use) Beijing China.

39. Aster LG Life Epotiv 2000 Date of Fee Nil Me Too Life Sciences, IU/0.5ml Pre- application Deposite Sciences, Ltd, filled syringe. 02.10.2012 d CoPP No. New Factory:- Each 0.5ml confirm 2012-A1- Garden 601, contains:- ed 1460 Dated Town, Yongje- rh 50000 20th June, Lahore/ Dong, Erythropoeitin… Dated 2012 Iksan-si ……. 2nd Jeonbuk- ……………….2 October, GMP do, Korea. 000 IU 2012 + No/date. Head (For Human 50000 (2007-A4- Office:- Use) dated 6th 0011) LG Twin Novemb Towers, er, 2013 DML No 20, Yoido- 2012-F1- Dong, Total 0108 Dated Youngdun Rs.1000 16-5-2012 gpo-gu, 00/- Seoul, Korea. 40. Aster LG Life Epotiv 4000 Date of Fee Me Too Life Sciences, IU/0.4ml Pre- application Deposite Sciences, Ltd, filled syringe. 02.10.2012 d CoPP No. New Factory:- Each 0.4ml confirm 2012-A1- Garden 601, contains:- ed 1460 Dated Town, Yongje- rh 50000 20th June, Lahore/ Dong, Erythropoeitin… Dated 2012 Iksan-si ……. 2nd Jeonbuk- ……………….4 October, GMP do, Korea. 000 IU 2012 + No/date. Head (For Human 50000 (2007-A4- Office:- Use) dated 6th 0011) LG Twin Novemb Towers, er, 2013 DML No 20, Yoido- 2012-F1- Dong, Total 0108 Dated Youngdun Rs.1000 16-5-2012 gpo-gu, 00/- Seoul,

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Korea

41. Aster LG Life Epotiv 10000 02.10.2012 Fee 0 Me Too Life Sciences, IU/1 ml Deposite Sciences, Ltd, Injection. d CoPP No. New Factory:- Each 1ml confirm 2012-A1- Garden 601, contains:- ed 1459 Dated Town, Yongje- rh 50000 20th June, Lahore/ Dong, Erythropoeitin… Dated 2012 Iksan-si ……. 2nd Jeonbuk- ……………….1 October, GMP do, Korea. 0000 IU 2012 + No/date. Head (For Human 50000 (2007-A4- Office:- Use) dated 6th 0011) LG Twin Novemb Towers, er, 2013 DML No 20, Yoido- 2012-F1- Dong, Total 0108 Dated Youngdun Rs.1000 16-5-2012 gpo-gu, 00/- Seoul, Korea 42. Getz Gan & Insulog Solution 14.11.2012 100000 0 Me Too Pharma, Lee for Injection in 03.09.2015 Karachi Pharmace Cartridge 100 uticals, unit/ml. No.8, Each ml Jingsheng contains:- North 3rd Insulin Lispro Street, USP…… 100 Golden units (rDNA Bridge Origin) Science (equivalent to Industrial 3.47mg) Base, (For Human Tongzhou Use) District Beijing,C

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hina.

43. A.A. Caspian Heparodic ® 03.12.2012 50000+ 0 Me Too Pharma, Tamin 5000 Solution. 50000 Karachi Pharmace Each 1ml utical Co., ampoule Site: (injectable First solution) Entrance, contains:- Rasht Heparin Sodium Industrial USP…………50 Zone, 00 IU Benzyl P.O.Box alcohol……… 43375- ……..B.P……9. 1116, 45 mg Sodium Rasht Chloride …….. Iran. ……..B.P……… Head .9 mg Office (Anticoagulant No.1 agent) DarouGos (For Human ter Budg. Use) Beastoon Ave., Dr. Fatemi sq, Tehran, Iran. 44. Genetics Zavod Rosinsulin R 07.12.2012 100000 0 Pharmace Medsintez Solution for uticals , LLC injection 100 Pvt, Russia. IU/ml Lahore. Each 1ml contains: Insulin human recombinant… ….100 IU (Insulin) (For Human Use)

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45. Genetics Zavod Rosinsulin M 07.12.2012 100000 0 Pharmace Medsintez mix 30/70 uticals , LLC suspension for Pvt, Russia. hypodermic Lahore. injection 100 IU/ml Each 1ml contains: Insulin human recombinant… ….100 IU (Insulin) (For Human Use) 46. Genetics Zavod Rosinsulin C 07.12.2012 100000 0 Pharmace Medsintez suspension for uticals , LLC hypodermic Pvt, Russia. injection 100 Lahore. IU/ml Each 1ml contains: Insulin human recombinant… ….100 IU (Insulin) (For Human Use) 47. SCILIFE M/S BIVAL 25.02.2013 100000 0 Me Too Pharma Shenzhen (Bivalirudin) (pvt) Ltd Salubris Lyophilized Pharmace Powder for uticals Co injection of Ltd, Infusion 250 mg. China. Each vial contains:- Bivalirudin….25 0 (Anti- Thrombotic Agent) 48. Martin Nanogen PEGCYTE PFS 13.03.2013 50000+5 0 Dow Biopharm Pegfilgrastem 0000 Pharmace aceutical, Solution for uticals Vietnam Injection Limited, 6mg/.5ml Karachi.

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49. Sind Changchu STERILE 13.05.2013 50000 50000 Me too Medical n BCHT WATER FOR Stores, Biotechno INJ 0.5ML Karachi. logy FOR company RECONSTITUT China ION OF MENINGOCOC CAL POLYSACCHA RIDE VACCINE GROUP ACYW135 50. Pharmevo Shandong Eposino 10000 11.06.2013 100000 0 Kexing IU Pre-filled Biopharm Syringe aceuticals, Injection Jinan Each Pre-filled China syringe contains:- Erythropoietin …10000 IU/1ml (Anti-anemic). (For Human Use) 51. SCILIFE M/S ENOXA 27.06.2013 50000 50000 Me Too Pharma HEBEI Enoxaparin (pvt) Ltd., Changsha Sodium Injection Karachi n 20 mg/.2ml PFS Biochemic al Pharmace uticals Co Ltd, China. 52. SCILIFE M/S ENOXA 27.06.2013 50000 50000 Me Too Pharma HEBEI Enoxaparin (pvt) Ltd., Changsha Sodium Injection Karachi n 40 mg/.4ml PFS Biochemic al Pharmace

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uticals Co Ltd, China.

53. SCILIFE M/S ENOXA 27.06.2013 50000 50000 Me Too Pharma HEBEI Enoxaparin (pvt) Ltd., Changsha Sodium Injection Karachi n 60 mg/.6ml PFS Biochemic al Pharmace uticals Co Ltd, China. 54. SCILIFE M/S ENOXA 27.06.2013 50000 50000 Me Too Pharma HEBEI Enoxaparin (pvt) Ltd., Changsha Sodium Injection Karachi n 80 mg/.8ml PFS Biochemic al Pharmace uticals Co Ltd, China.

Decision: Registration Board deferred the case for completion of applications, remaining fee, CoPP status, information regarding availability in country of origin and deliberations regarding requirement for bio-similarity of products

Case No.06: Following cases are originating from Non-SRA countries but require urgent attention as these products are vaccines having WHO pre- qualification OR products which do not require extensive evaluation and has been registered previously under the Drug Act, 1976.

Sr.#. Name of Manufactur Name of Drug Date of Documen Remarks Decision Indenter/ er (s)/ application / tary of RB Manufactur Composition & Fee status Details er Therapeutic Group 1. M/s Sindh Manufactur SK Albumin Date of CoPP No. Me too Approved Medical ed by: 20% Injection Application 2015-AJ- subject to Stores, 13- M/s. SK (Human 19-2-2013 1143 1. Plasbumin complianc B, Block 6, Plasma Co., Serum Date 18-9- (Talecris- e of PECHS, Ltd. Albumin) – Fee Deposited 2015 USA/ Import 50000+ GMP No.

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Shahrah e Office 100ml 50000 2015-D1- Popular Int’l) Policy for Faisal, address: Composition: 1563 Finished Karachi. 310, Each 100ml Fee Balance Dated 5-6- 2. Albutien Drugs and Pangyo-ro, contains ….. 2015 (Grifols/S. confirmat Bundang- - Human Nil DML No. Ejazuddin) ion of 352 dated gu, Serum storage 01-5-2015 Seongnam- Albumin, 20g facility of si, - Sodium importer.

Gyeonggi- Caprylate …

do, 463- 0.2659g 400, Korea. - N-Acetyl-D, Plant L-Tryptophan address: …… 0.3940g 430-11, - Sodium Nambu- Chloride … daero, q.s. Osan-si, - Sodium Gyeonggi- Hydroxide.. do, q.s. Republic or - Water for Korea. Injection ..q.s. Pack Size: Box of 01 Vial x 100ml (Demanded MRP Rs.14,137.00/ Vial of 100ml)

Blood Derivative

2. M/s Sindh M/s. SK Liv-Gamma Date of CoPP No. Me too Approved Medical Plasma Co., SN Injection Application 2015-A1- subject to Stores, 13- Ltd. (Human 19-2-2013 1141 1.Pentaglobi complianc B, Block 6, Office Normal Prod Lic n e of PECHS, address: Immunoglobui Fee Deposited No. 5022 (Biotest – Import 50000+ Dated 28- Shahrah e 310, n in Maltose Germany/Eas Policy for 50000 4-2015 Faisal, Pangyo-ro, (pH4.25)) – Free Sale tern Trade) Finished Karachi. Bundang- 2500mg / Fee Balance Certificate Drugs and gu, 50ml 2015-AI confirmat Seongnam- Nil 1140 ion of si, Composition: dated 18- storage Gyeonggi- Each 1ml 9-2015 facility of

do, 463- contains ….. importer.

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400, Korea. - Human Indication Plant Normal s address: Immunoglobul 430-11, in-G .. 50mg Blood Nambu- - Maltose Deficienc daero, Hydrate.. ies Osan-si, 100mg Gyeonggi- - Water for do, Injection ..q.s. Republic or Pack Size: Korea. Box of 01 Vial x 2500mg/50ml (Demanded MRP Rs.19,376.00/ Vial of 50ml)

Blood Derivative

3. Genome Vins S-Venom Anti Date of Deposited Me Too Approved Pharmaceutic Bioproducts Serum Liquid application fee confirmed subject to als (Pvt) Limited, Each ml 08.12.2010 15000+ complianc Ltd., Hattar. Hyderabad neutralizes 35000+ e of Andhara following 50000 Import Pradesh, venoms dated 27- Policy for India. contains:- 11-2015 Indian Finished Cobra……..0.6 Drugs and 0mg Common Balance confirmat Krait…..0.45m fee ion of g Russell’s Nil storage Viper….0.60m facility of g Saw scaled importer. Viper..0.45mg Firm will Cresol I.P.< provide 0.25% v/v as valid preservative CoPP and (Specific Immunoglobuli Chairman n) will (For Human permit Use) issuance of registratio n letter.

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4. Shah Green BCG Vaccine 04.11.2011 Fee Me Too Deferred Enterprises, Signal Bio (Freeze – deposited for 41-44, Akbar Pharma Pvt Dried BP) 15000 confirmati Market, Jang Ltd Each Vial on of Building, INDIA contains 1mg of Balance remaining Muree Road, Bacillus fee fee, CoPP Rawalpindi Calmette 85000 cantt. Guerin (BCG) status etc. freeze-Dried. (Unit/Dose 1mg) (1.5%w/v) 5. Bajwa Sons, Furen Hepacin 07.05.2012 Deposited Me Too Deferred Lahore. / Pharmaceuti Injection 25000 fee as serial cal Group iu/5ml Each 15000+ no-7&8 of Co. Ltd., 5ml vial 35000+ Medi Henan, contains:- 50000 Mark China. Heparin from the Sodium eq to Balance Heparin……..2 fee same 5000 i.u Nil source. (Anticoagulant) Firm will . be advised to provide latest Whole sale Agency Certificat e from manufact urer. 6. Sind Beijing MENVAC - Date of Deposite Me too Deferred Medical Luzhu ACYW application d fee for Stores, Biopharma 0.5ML VIAL 26.09.2013 Rs.10000 CoPP No. complete Karachi. ceutical, MENINGOC 0/- 121100B0/14 informati China OCCAL 010 dated 30- on as per POLYSACCH 3-2012 CoPP ARIDE VACCINE GMP No. CN GROUP 20120047 ACYW135 validity 12-6- 2017 Demanded issuance date MRP 13-6-2012

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7. Medi Mark Furen MEDIRIN 23-05-2013 Deposited Me too Deferred Pharma, Pharmaceuti 5000IU fee as serial Lahore. cal Group HEPARIN Rs.100000 no-5 of Co., Ltd, SODIUM 5000 Bajwa Xuan Wu IU/1ML Sons Economic Anti Coagulant Lahore Developing -area, Luyi from the Country, same Henan source. China. Firm will be advised to provide latest Whole sale Agency Certificat e from manufact urer. complete informati on for CoPP is also required 8. Medi Mark Furen MEDIRIN 23-05-2013 Deposited Me too Deferred Pharma, Pharmaceuti 25000IU fee as serial Lahore. cal Group HEPARIN 100000 no-5 of Co., Ltd, SODIUM 5000 Bajwa Xuan Wu IU/1ML (5ml) Sons Economic Anti Coagulant Lahore Developing -area, Luyi from the Country, same Henan source. China. Firm will be advised to provide latest Whole sale Agency Certificat e from

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manufact urer. Complete informati on for CoPP is also required

Decision: The decision of Registration Board has been noted against each item.

Case No.07: Miscellaneous Cases

a. Registration of drugs of M/s. Excel Pharma-Inspection abroad already conducted

M/s Excel Health Care, Karachi has applied for registration of their following products. The company has deposited an amount of Rs 100,000/- against each product.

The policy of advance parallel inspection was discussed in 237th Meeting of Registration Board; however, the policy was revised in 238th Meeting of Registration Board. Meanwhile, the inspection abroad was conducted which is summarized above. Earlier the case was placed in 244th Meeting of Registration Board where in it was decided that the case is in complete and should be processed through ECBD. Registration Board in its 249th Meeting directed the Biological Division to evaluate the submitted dossiers of products including resemblance of brand names. The evaluation is tabulated as below;

Decision in 250th Meeting: Registration Board deferred request of the firm for clarifications of CoPP for co-pack products, details of already registered drugs in the name of company and review of new molecules applied by the company. The firm has provided following documents for Menorin tablets 0.3mg, Menocare and Menstrol Tablets and. The case details as under;

S. Name and Name of Panel Earlier Latest Decision of No. Composition of Manufacturer Inspection Evaluation Documents RB the Drug Report submitted by the firm Minutes for 254th Registration Board Meeting 546

1. MENORIN Xinjiang Recommended The firm The firm Approved 0.3mg Nuziline Bio- by the panel. has has subject to (Conjugated pharmaceutical submitted submitted compliance Estrogen 0.3mg Co., Ltd. application fresh CoPP, of Import tablet) China. on Form 5 GMP and Policy for Form 5A A along FSC. Finished Fee with Rs.100000/- required Drugs and Demanded fee. confirmation price Rs. 600/ FSC, GMP of storage pack and CoPP facility of Pack size 14’s importer Mee too status provided, Premarin 0.3mg however, Registered of documents M/s. Pfizer, are out Karachi. dated. Similar product Premarin is already registered in the name of M/s. Pfizer Karachi.

2. MENOCARE Furen Recommended The firm The firm Approved tablets Pharmaceutical by the panel has has subject to (Estradiol valerate Group Co., Ltd, submitted compliance 2mg and China application submitted of Import Cyproterone on Form 5 fresh CoPP, Policy for acetate 1mg) A along Finished with GMP and required Drugs and

FSC and co fee. confirmation FSC, GMP pack of storage and CoPP facility of justification. provided, importer however, documents are out dated. The product is also combo packed with plain Estradiol 2mg tablets which is not

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mentioned in CoPP or FSC. Similar product Climen is already registered in the name of M/s. Schering AG, Karachi having plain Estradiol 2mg tablets. 3. MENSTROL Furen Recommended The firm The firm Approved tablets Pharmaceutical by the panel has has subject to (Levonorgestrel Group Co., Ltd, submitted compliance 0.5 mg China application submitted of Import Estradiol 2mg) on Form 5 fresh CoPP, Policy for A along Finished with GMP and required Drugs and FSC and co fee. confirmation FSC, GMP pack of storage and CoPP facility of justification. provided, importer however, documents are out dated. The product is also combo packed with plain Estradiol 2mg tablets which is not mentioned in CoPP or FSC. Similar product is already registered in the name

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of M/s. Schering AG, Karachi having plain Estradiol 2mg tablets.

Case of above mentioned three (3) products is placed before the Board for a decision.

Registration Board in its 249th Meeting directed the Biological Division to evaluate the submitted dossiers of products including resemblance of brand names. The evaluation is tabulated as below;

S. No. Product Exporting Inspection abroad Evaluation by Decision of Specifications Company report the Directorate RB Team Members of Biological Mr. Adnan Faisal Drugs Saim (DDC) Mr. Asif Jalil (ADC) 1. FEMININ tablets Furen Recommended by The firm has Approved (Cyproterone Acetate Pharmaceutical the panel submitted fresh subject to 2mg & Group Co., Ltd, CoPP, GMP and compliance ethinyloestradiol China FSC of Import 35mcg) Mee too, similar Policy for formulation of Finished Schering AG is already registered Drugs and with Brand name confirmation Diane-35 of storage facility of importer 2. ANDROL tablets Furen Recommended by The firm has Approved (Cyproterone Acetate Pharmaceutical the panel submitted fresh subject to 50mg) Group Co., Ltd, CoPP, GMP and compliance

China FSC of Import Policy for Mee too, similar Finished product Androcur is already Drugs and registered in the confirmation name of M/s. of storage Bayer, Karachi. facility of

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importer 3. GONACOR INJ Yantai Beifang Recommended by The firm has Deferred for 2000IU Pharmaceutical Co., the panel submitted fresh Biosimilarity (Human Chorionic Ltd. China CoPP, GMP and data, Gonadotropin) Me too, similar FSC composition product IVF-C is and packs already registered

in the name of M/s. Galaxy Karachi in 5000iu. The firm has proposed new brand name as HCG-Excel

4. GONACOR INJ Yantai Beifang Recommended by The firm has Deferred for (Human Chorionic Pharmaceutical Co., the panel submitted fresh Biosimilarity Gonadotropin 5000IU) Ltd. China CoPP, GMP and data, Me too, similar FSC composition product IVF-C is and packs

already registered in the name of M/s. Galaxy Karachi in 5000iu. The firm has proposed new brand name as HCG-Excel 5. HMG MASSONE Yantai Beifang Recommended by The firm has Deferred for (Human Menopausal Pharmaceutical Co., the panel. submitted fresh Biosimilarity Gonadotropin 75IU) Ltd. China However the CoPP, GMP and data, panel has given FSC composition composition as and packs

FSH 75IU +LH 75IU

Me too, similar product IVF-M is already registered in the name of M/s. Galaxy Karachi in 75iu. The product is combination of75iu of FSH and 75iu LH. The firm has proposed new brand name Menopour

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6. HMG MASSONE Yantai Beifang Recommended by The firm has Deferred for (Human Menopausal Pharmaceutical Co., the panel. However submitted fresh Biosimilarity Gonadotropin 150IU) Ltd. China the panel has given CoPP, GMP and data, composition as FSC composition FSH 150IU +LH and packs 150IU

Me too, similar product IVF-M is already registered in the name of M/s. Galaxy Karachi in 150 iu. The product is combination of 150iu of FSH and 150iu LH. The firm has proposed new brand name as Menopour 7. ENDRALIN Maa’nshan Recommended by The firm has Deferred for (Alarelin 150ug-Gnrh) Fengyuain the panel. submitted fresh Biosimilarity Pharmaceutical Co., CoPP, GMP and data,

Ltd Chian FSC composition and packs

The product is new molecule may be treated as per policy.

8. LUTRONE INJ Maa’nshan Recommended by The firm has Deferred for 100UG Fengyuain the panel. submitted fresh Biosimilarity (Gonadorelin 10‟s) Pharmaceutical Co., CoPP, GMP and data, Ltd China. FSC composition The product is and packs new molecule may be treated as per policy.

Decision in 250th Meeting: Registration Board deferred request of the firm for clarifications of CoPP for co-pack products, details of already registered drugs in the name of company and review of new molecules applied by the company. Decision: Registration Board considered all the above cases and decision is recorded against product the last column of the table.

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b. Local manufacturing of biological drugs of M/s. Macter International, Karachi

S. Documents/ data Product Details Documents / data Remarks No. as per requirement submitted by Macter of DRB 246 1. Legalized GMP Etanercept Legalized GMP Original duly certificate of (Recombinant certificate no. Notarized and biological drug as Human Tumor CN20110019 issued by Legalized evidence that Necrosis State Food and Drug GMP manufacturer is an administration issued on certificate no. authorized 09/10/2011 and valid up CN 20110019 manufacturer of that to 08/10/ 2016. ISSUED BY particular biological Legalized COPP no. State Food and drug in its country 15009 for finished drug Drug of origin 25 mg issued by administration Shanghai Municipal indicating Food and Drug etanercep Administration. Issued (Recombinant on 29/01/2015 and valid Human Tumor up to 29/01/2017. Necrosis Factor-a Receptor II- IgG FC fusion protein) issued on 09/10/2011 and valid up to 08/10/2016. Original duly notarized and legalized COPP no. 15009 for finished drug 25 etanercept (Recombinant Human Tumor Necrosis Facter-a Receptor II- IgG 2. Structural similarity Structural similarity: Studies are of subject biological Primary available in drug product (ready structure/Identity. provided DMF to fill bulk) with Comparison of cDNA of by reference biological Momentum with Enbrel, manufacturer

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product (innovator). Comparison of amino Protein acid sequence by LCMS, sequence N- Terminal sequencing compared with by Edman degradation, C WHO terminal sequencing by sequence. LC-MS/MS, UPLC peptide mapping. Secondary structure by Circular Dichorism, UV/visible spectrophotometry. N- Glycosylation analysis. Identity by ELISA, Peptide mapping.

Purity: Purity comparison with reference drug by SEC- HPLC SDS PAGE (Purity) IEX analysis for charged moieties IEF analysis, Western blotting Safety testing of : Host Cell DNA, Host Cell protein, Endotoxin levels.

Biological activity: Comparative biological activity Momentum vs Enbrel by TNF sensitive L929 cell cytotoxicity neutralization assay.

3. Biocomparability Comparative analysis of Stability studies including locally produced drug studies reports identity testing to product with Reference of local parent molecule, medicinal product batches purity testing, in (Enbrel- Wyeth). provided. vitro biological activity / potency Identity: Isoelectric testing and toxicity focusing,

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with support of IEF Purity: SDS PAGE data, gel Potency: ELISA electrophoresis, General safety tests western blot and Bacterial Endotoxin test, other analytical Sterility test and methods and abnormal toxicity test. stability studies of Real time stability and finished drug. accelerated stability studies. 4. Others Animal toxicity studies Animal done by CP Goijian, Toxicity China: studies are part  Study 301-07 of DMF provided. Acute (single dose) Bioequivalence Toxicity of rhTNFR: Fc studies, for injection in Mice. efficacy clinical trials  Study 301-08 Repeat dose toxicity study of and post rhTNFR-Fc fusion marketing protein administered to surveillance Rhesus by subcutaneous studies done injection. by Shanghai CP Goujian are  Genotoxicity. provided.  Carcinogenicity (including supportive toxicokinetics evaluations).  Reproductive and Developmental Toxicity.  Study 301-09 Local toxicity study of rhTNFR:Fc in rabbits.  Study 301-10 Hemolytic study of recombinant human TNFR-antibody fusion Protein.

Bioequivalence and efficacy Clinical trials Animal data is submitted: Toxicity  Reports of studies are part Biopharmaceutical of DMF Studies. provided.  Reports of Studies Bioequivalence Pertinent to Pharmacokinetics using studies, Human Biomaterials. efficacy

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 Reports of Human clinical trials Pharmacokinetic (PK) and post Studies. marketing  Reports of clinical trials for Efficacy and Safety surveillance Studies. studies done  Reports of Post- by Shanghai Marketing Experience. CP Goujian are  Case Report Forms and provided. Individual Patient Listings. Approved.

Decision: The case was deferred for the requirement of section, manufacturing/ testing facilities required for the particular product of the firm.

The firm has section approval for the manufacturing of recombinant human DNA protein drugs. Etanercept is a recombinant human DNA protein drug. The firm has provided details of manufacturing process and related equipments of each manufacturing step and detail of trained persons. List of testing method required for quality testing and related QC equipments and trained persons. Copy of last inspection report is provided verifying all the equipment mentioned above. Firm has provided import documents of the procured reference standard (WHO & EP), and reagents required for quality control of the product. Manufacturing schedule on campaign basis of register products is also provided. The manufacturing schedule shows that facility is having vacant capacity for 09 months allowing ample time of clearance during product switch over facility also has disposable flow path of drug which eliminates the risk of cross contamination facilities has validated cleaning procedure.

Decision: Registration Board evaluated the documentary details submitted by firm of manufacturing system, process, equipment and campaign manufacturing protocols with reference to its previous decision. The Registration Board APPROVED the registration of Biological Product Etanercept (Recombinant Human Tumor Necrosis Factor (a Receptor II Ig G fusion protein) 25 mg lyophilized powder for injection, as per conditions of bio comparability laid down in 246th meeting of RB. The campaign manufacturing shall be as per international standards and cross contamination with other biologicals being manufactured in the same section shall be avoided by using dedicated vessels and disposable flow path for each product. The bulk concentrate of drug substance, Etanercept (Recombinant Human Tumor Necrosis Factor) shall be imported from Shanghai CP Goujian Pharmaceutical Co. Ltd Shanghai China for further processing in to finished product at M/s Macter Int. Ltd Karachi.

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c. Case of M/s. Graton Pharma, Karachi for the registration of Interferon Alfa 2B 3000IU /vial (Lipheron from Beijing Shanglu, China) along with diluent.

The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered in any meeting till date .The firm has provided evidence of documents and fee challans submitted by them. 2. The case of the firm belongs to pre devolution at the time to Drugs Control Organization, Ministry of Health. The section tried to retrieve the application from old record but still the record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been provided by the company.

Earlier Decision of the Board: The Board deferred the case for completion of documents by the firm and to present the case with all available details in the next meeting of Registration Board.

M/s Graton Pharma, Karachi as has requested in the previous meeting for the import of their interferon. The case was considered and deferred for provision of original documents. The firm has submitted photocopies of their documents. In the instant shifting of record of biological division and touring abroad of DDC (BIO) their file are not traceable instantly. 2. The firm has also submitted documents regarding registration of steroil water for injection for their products. They have provided on form-5 CD version of registration dossiers, certificate of pharmaceutical product (Photocopy). However the firm has not submitted additional fee required for water for injection and that promised to submitted at the earliest before issuance of any letter regarding inspection abroad are registration letter. 3. The Board may consider their case on merit, whereas biological division is retrieving their documents and shall present before the Board as soon as they are available. Meanwhile the process of foreign inspection as per import policy may be considered and the firm may be directed to give undertaking on judicial stamp paper that outcome of the inspection what so ever will not confer the right of consideration if the firm could not qualify for the GMP certification. The firm shall be exempted from inspection, if their inspection has waiver as per import policy. It is a similar case of finished import for which policy decision has been asked however the case is pending since Ministry of Health before the DRAP Act 2012.

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Decision: Registration Board upheld the previous decision, as no any new documents / files was submitted by the firm so far and deferred the case for completion of documents / fresh submission by the firm. d: Change in the Generic Name and CFU concentration of Bacillus Calmette Guerin BCG Vaccine, SII-ONCO-BCG ( Reg. No. : 053818), of M/S. Hospital Services & Sales, Karachi.

M/s. Hospital Services & Sales, Karachi has submitted an application on dated 03rd April’ 2014 for the approval of “Change in the generic name and CFU concentration for the registered product i.e. Bacillus Calmette Guerin BCG Vaccine, SII-ONCO-BCG” as the manufacturer M/s. Serum Institute of India, Pune – India has made some changes in the generic name and CFU concentration of the product for complying and meeting USP specifications of test of viability and to remove the word “Vaccine” from the product generic name.

Earlier Name and Composition New Name and Composition

Bacillus Calmette Guerin (BCG) vaccine BCG Live U.S.P. (Lyophilized) SII-ONCO-BCG, SII-ONCO-BCG (Lyophilized) Powder for injection Powder for Intravesical Instillation Each vial contains:- Bacillus Calmette-Guerin Strain: Each vial contains:- 40mg/ml (between 1- 8 X 108 CFU). Bacillus Calmette-Guerin Strain: 40mg/ml (between 1 – 19.2 X 108 CFU).

M/s. Hospital Services & Sales, Karachi has deposited the required fee and submitted following supporting documents:

1- Copy of registration letter and renewal status of the product. 2- Approval from the concerned regulatory authority in the country of origin duly attested by Pak Embassy. 3- Justification for the said changes / amendments on manufacturer’s letter head duly signed and stamped duly notarized in the country of origin. 4- FSC reflecting the said changes duly attested by Pak Embassy. 5- CPP reflecting the said changes duly attested by Pak Embassy. 6- Technical data related to the said changes in the product registration including Stability data.

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The request of the firm was referred to three experts and experts’ opinion is summarized below;

Dr. Qaiser Mahmood Khan Recommended that the change may be allowed National Institute of Biotechnology and as per rules. Genetic Engineering, Faisalabad.

Dr. Qurban Ali Since the product remains the same and Principal Scientific Officer, NYL changes not affecting the quality and safety of Islamabad. the product besides adding more clarity on the aspect of its name with relevance to its clinical use; it is recommended that we may entertain

the request and allow the change of name and product to be USP compliant.

Dr. Syed Uzair ul Ghani Irfan (Ex. Member of No reply received. ECBD) Islamabad.

The said case already has been discussed in 248th DRB meeting dated 18-19th Mar’ 2015 and company was asked to provide more data for assessment.

As the applicant has provided all the relevant data and documents, therefore the case is again placed before the Drug Registration Board for decision.

Decision: Registration Board discussed the case and as per CoPP, Free Sale Certificate and registration status in other countries with the same CFU Bacillus Calmette-Guerin Strain: 40mg/ml (between 1 – 19.2 X 108 CFU. The Registration Board approved change of generic name omitting word Vaccine from “Bacillus Calmette Guerin (BCG) vaccine (Lyophilized) SII- ONCO-BCG” and change to “BCG Live U.S.P. SII-ONCO-BCG” with CFU concentration as per CoPP / USP specifications, and based on the recommendation of two of the experts.

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e: Change of manufacturing site of Ropegra (Peg Interferon Alfa 2A) manufactured by (M/S F.HOFFMANN LA-ROCHE PAKISTAN LTD, approved in 237th meeting of Registration Board.

Registration Board in last meeting decided to take up all the cases of 237th meeting of Registration Board holistically. However due to lake of human resource and time constraints the issue of 237th meeting could not be taken up in this meeting. Meanwhile Roche Pakistan Ltd has requested to grant change of manufacturing site of their product which was approved in the above said meeting. The firm has submitted the legalized and notarized CoPP issued by EMA of the new site. The firm submits that the bridging stocks from previous site are about to be finished, which will create problems for those patients who are on this specific medicament. The request of the firm is placed before the Registration Board. The new EMA approved site is at F. Hoffmann-La Roche Ltd., Wurmiweg, 4303 Kaiseraugust, Switzerland.

Decision: Registration Board deliberated in detail on the issue of 237th meeting of the Registration Board specifically on the issue of not recording the minutes and issuance of a registration letter. The consensus was developed to defer the case for the next meeting, meanwhile Biological Division was directed to bring case and parawise comments of Biological Division, as submitted in the Sindh High Court, regarding the alleged registration of Ropegra. The request of the firm change of manufacturing site was deferred and shall be considered accordingly.

f: Transfer of registration from M/s Highnoon Labortries Ltd, Lahore To M/S Titlis Pharma, Lahore

Highnoon Labortries has submitted No Objection Certificate No. BH/RA-001/2015 on 13-3-2015.The firm has requested transfer of registration of imported drugs recombinant human erythropoietin having a brand name of GEREPO 300IU Prefilled Syring from Highnoon Laboratories 17.5 km Multan Road, Lahore to M/s Titlis Pharma 528-A Sunder Estate, Lahore. The firm has submitted fee challan of 100000/-. The details of the product are as follows.

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S.No Company Product Generic Name Reg.No. & Fee Status Date of Name Name Date of Application & Registration Documents details 1. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 2000IU Human 047587 Rs.100000/- 07-4-2015 Pharma, Injection Erythropoietin CoPP No. 20150078 528-A, Date of Balance. Nil Valid until 02/2017 Sundar Registration Industrial 22-2-2008 Prod License No. Estate, GYZZS20053076 Raiwind Renewal. dated 20-9-2010 Road, Valid up to 17- Lahore 2-2018 GMP Certificate Date of No. CN20130130 submission dated 15-5-2013 renewal fee 17-2-2013 Sole Agent Certificate. Yes Dated 11th Feb, 2015

2. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 3000IU Human 047588 Rs.100000/- 07-4-2015 Pharma, Injection Erythropoietin 528-A, Date of Balance. Nil CoPP No. 20150089 Sundar Registration Valid until 02/2017 Industrial 22-2-2008 Estate, Prod License No. Raiwind Renewal. GYZZS20000026 Road, Valid up to 17- dated 20-9-2010 Lahore 2-2018 Date of submission GMP Certificate renewal fee No. 17-2-2013 CN20130130 Dated 15-5-2013

Sole Agent Certificate Yes Dated 11th Feb, 2015

3. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 4000IU Human 047589 Rs.100000/- 07-4-2015 Pharma, Injection Erythropoietin 528-A, Date of Balance. Nil CoPP No.20150080

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Sundar Registration Valid until 02/2017 Industrial 22-2-2008 Estate, Prod License No. Raiwind Renewal. GYZZS 20053077 Road, Valid up to 17- Dated 20-9-2010 Lahore 2-2018 Date of GMP Certificate submission No. renewal fee CN20130130 17-2-2013 Dated 15-5-2013

Sole Agent Certificate. Yes Dated 11th Feb, 2015

4. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 5000IU Human 047590 Rs.100000/- 07-4-2015 Pharma, Injection Erythropoietin 528-A, Date of Balance. Nil CoPP No. 20150091 Sundar Registration valid until 02/2017 Industrial 22-2-2008 Estate, Prod License No. Raiwind Renewal. GYZZS 20133012 Road, Valid up to 17- Dated 28-11-2013 Lahore 2-2018 Date of GMP Certificate submission No. renewal fee CN20130130 17-2-2013 Dated 15-5-2013

Sole Agent Certificate. Yes Dated 11th Feb, 2015

5. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 2000IU Human 047591 Rs.100000/- 07-4-2015 Pharma, Prefilled Erythropoietin 528-A, Syringe Date of Balance. Nil CoPP No. 20150078 Sundar Registration valid until 02/2017 Industrial 22-2-2008 Estate, Prod License No. Raiwind Renewal. GYZZS 20053076 Road, Valid up to 17- Dated 20-9-2010 Lahore 2-2018 Date of GMP Certificate submission No. renewal fee CN20130130 17-2-2013 Dated 15-5-2013 Minutes for 254th Registration Board Meeting 561

Sole Agent Certificate. Yes Dated 11th Feb, 2015

6. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 3000IU Human 047592 Rs.100000/- 07-4-2015 Pharma, Prefilled Erythropoietin CoPP No. 20150089 528-A, Syringe Date of Balance. Nil Valid until 02/2017 Sundar Registration Industrial 22-2-2008 Prod License No. Estate, GYZZS 20000026 Raiwind Renewal. Dated 20-9-2010 Road, Valid up to 17- Lahore 2-2018 Date of GMP Certificate submission No. renewal fee CN20130130 17-2-2013 Dated 15-5-2013

Sole Agent Certificate Yes Dated 11th Feb, 2015

7. M/S GEREPO Recombinant Reg No. Deposited Date of application TITLIS 4000IU Human 047593 Rs.100000/- 07-4-2015 Pharma, Prefilled Erythropoietin 528-A, Syringe Date of Balance. Nil CoPP No. 20150080 Sundar Registration Valid until 02/2017 Industrial 22-2-2008 Estate, Prod License No. Raiwind Renewal. GYZZS 20053077 Road, Valid up to 17- Dated 20-9-2010 Lahore 2-2018 Date of GMP Certificate submission No. renewal fee CN20130130 17-2-2013 Dated 15-5-2013

Sole Agent Certificate Yes Dated 11th Feb, 2015

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The firm has submitted renewal fee Rs 20000/- for each of the imported product on 17-6-2013 and submitted application on form-5-A. The manufacturer is NCPC International Corporation No. 217/1 East Heping Road, SHIJIAZHUANG, HEBEI, PR China. The dossiers are submitted in CTD and routine format. The case is submitted before the Board for consideration. Decision: Registration Board decided as follows:  Cancellation of above registered products from M/s Highnoon Laboratories Ltd, Lahore.  Grant of above registrations in favor of M/s. Titlis Pharma, Lahore. Chairman, Registration Board will permit issuance of registration letter after comments of Cost & Pricing Division about MRP of the drug, compliance of Import Policy for Finished Drugs and confirmation of storage facility of importer.

g: Change of name of manufacutrer, change of address of manufacturing site , change of brand name, additional pack of 8,000 doses.

S.NO. COMPANY CHANGES CURRENT CHANGE REQUIREMENT NAME PRODUCT REQUIRED IF ANY COMPOSITION 1 U.M Brand Name Bursaplex Reg No Poulvac Bursaplex Fee deposited ENTERPRISES 020775 50000 dated 09-12- KARACHI IBD Virus, Strain 2013+50000dated 17- 2512 12-2013. 100EID50/ dose at release Total Rs.100000/- confirmed Bursal Diease antiserum 24 U per Manufacturing Lic dose No. 190 dated 23-5- 2013 Gentacin 30mg/L GMP and Free Sale in original complete

2 Manufacturer Mariel select Zoetis Inc.

3 Address of Mariel select, Inc. Zoetis Inc, Manufacturer 1168 Airport (Previously Doing Parkway Gaineville, Business As Pfizer Geogia 30503 USA. Inc.) 2000 Rockford Road Charles City, lowa 50616-9989 USA. 4 Additional 1000 & 2000 Doses Additional Pack of Pack 8000 Doses

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requested

Decision: Registration Board approved the Change in Name of Manufacturer from Mariel select, Inc. to Zoetis Inc, with the change of address of manufacturing site from 1168 Airport Parkway Gaineville, Geogia 30503 USA to 2000 Rockford Road Charles City, lowa 50616-9989 USA, and change of brand name from, Bursaplex Reg No 020775 IBD Virus, Strain 2512 to Poulvac Bursaplex Reg No 020775 (Strain 2512 100EID50/ dose at release bursal disease antiserum 24 upper dose Gentacin 30mg/L) in pack of 1000 & 2000 doses. The Registration Board rejected the request of the firm for additional pack of 8,000 doses.

h: M/S. Vetline International, Lahore.

On directions of Registration Board in instant meeting, Biological Division placed the case as per following details. Following applications of veterinary biological drugs were placed before the Board in its 249th, 250th and 251st Meeting of the Registration Board. S.No Name of Name of drug and its Date of Applicatio Pack size Shelf life . applicant and composition applicatio n form name of n and Fee exporter 1. Vet line ITA NEW (ND) 24.06.2010 Form 5 A 1000 2 years International Each dose contains:- Rs. doses vial Me too Lahore Inactivated Newcastle 100,000 status License Holder disease virus (NDV- confirmed Laprovet SZ) LaSota i. Reg Hungary strain……………… No.044901 Veterinay ….. GALLAMI Pharmaceutical Min 50PD50 NE ND s Ltd. Injection Hungary, by Marush Manufactured from by Marial Ceva-Phylaxia Italy Hungary with manufacturing contract with Lapro vet France.

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2. Vet line AVI POX 24.06.2010 Form 5 A 1000 30months International Live, freeze dried fowl Rs. doses vial Me too Lahore pox vaccine 100,000 status License Holder Each dose contains:- confirmed Laprovet Fowl pox virus, cutter 2’7 Hungary strain min. 10 EID50 i. Veterinay POXIMUN

Pharmaceutical (Live vaccine) E Injection s Ltd. Reg No. Hungary, 035031 by Manufactured Biomune by company Ceva-Phylaxia USA Hungary with marketed manufacturing Better contract with Traders Laprovet Faisalabad France.

3. Vet line AVI- 24.06.2010 Form 5 A 1000 18months International ND LASOTA + IB Rs. doses vial Me too Lahore Each dose contains:- 100,000 status License Holder Newcastle disease confirmed Laprovet virus LaSota Hungary strain…Min i. BIOVAC 5.5 Veterinay 10 EID50 ND IB Pharmaceutical Infectious bronchitis VACCINE s Ltd. virus B-48 by Well Hungary, strain…..Min Pharma 2.6 Manufactured 10 EID50 Lahore by (NEUVA Ceva-Phylaxia (Live vaccine) VETERIN Hungary with ARY manufacturing BIOLOGI contract with CAL, Lapro vet ITALY France. Reg No. 018806. ii. CEVA NB Reg No, 023401 by Marush.

iii. EVIPRO ND IB

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SOHOL Reg No. 011073 by Lohman Germany (Golden Harvest) 4. Vet line AVI IBD PLUS 29.06.2010 Form 5 A 500,1000 24months International Each dose contains:- Rs. and 2500 Me too Lahore IBD virus Winterfield 100,000 doses vial status License Holder 2512, G-61 strain, confirmed Laprovet min. 2.0 log 10 EID50 CALAVA Hungary C

Veterinay (Live vaccine) GUMBOR Pharmaceutical O PLUS s Ltd. Reg Hungary, No.043517 Manufactured from CA by Lab Ceva-Phylaxia Venzvella Hungary with by Khyber manufacturing Poultry contract with Faisalabad. Lapro vet France.

The Registration Board in its 251st Meeting decided as under;

Decision 251st Meeting : The Board deferred the case and advised firm to provide evidence/free sale certificate/CoPP clearly indicating all the manufacturing sites involved in the manufacturing process, issued by the regulatory authority of Hungary, duly notarized/ legalized by embassy of Pakistan in Hungary. Moreover, Dr. Amanullah Khan, Director DTL, Quetta requested to share above registration applications with him before further processing of the case.

The firm has submitted notarized, legalized and attested required documents by Pakistan Embassy, Budapest Hungry. The letter is issued by Veterinary Drugs Controlling Authority (National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest Hungary) certifying that Laprovet Hungary Veterinary Pharmaceuticals Ltd. 1107 Budapest, Horog u. 32-34. Hungary (Wholly owned and subsidiary of Laprovet, France) is licensed to manufacture veterinary biologicals. List of fully registered and freely sold vaccines are exclusively contract manufactured in Hungary by CEVA-PHYLAXIA Hungary. List of vaccine

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in the letter includes above mentioned four vaccines. The complete copy of set of dossiers was also shared with member Registration Board Dr. Amanullah Khan as per decision of the Board. Decision: Registration Board evaluated above dossiers, CoPP and documents approved by the regulatory body of the Hungry (Veterinary Drugs Controlling Authority (National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest Hungary) certifying that Laprovet Hungary Veterinary Pharmaceuticals Ltd. 1107 Budapest, Horog u. 32-34. Hungary (Subsidiary of Laprovet, France). The Registration Board approved the registration of four products of Vet line International Lahore tabulated above subject to compliance of Import Policy of Finished Drugs and confirmation of storage facility of importer.

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Item No.VI. Cases referred by Medical Device Division.

Case No.01: Inspection of Manufacturer Abroad M/s Sumbow Medical Instruments Co. Ltd, China.

Registration Board in its 242nd meeting held on 24th& 25th February, 2014 considered and approved the following medical devices of M/s BNS Trading Est, Lahore subject to inspection of manufacturer abroad, verification of storage facilities etc as per policy:- S.# Name of Importer and Name of Medical Device Pack size Shelf Manufacturer/Exporter Life (i) M/s BNS Trading Est, Safe 1 Brand IV Cannula 1’s 3 years 244-Allama Iqbal Road, (Pen Type) Mustafabad, Lahore. Manufactured by (14G, 16G, 18G, 20G, M/s Sumbow Medical Instruments 22G, 24G) Co. Ltd, 16F Chengtou Building, No.68 Heji Street, Jiangdong District, China.

(ii) -do- 3S Safe Infusion Set 1’s 3 years

Dr. Sheikh Akhtar Hussain, Deputy Director General, DRAP, Lahore and Mr. Khalid Mahmood, the then DDC (QC), DRAP, Islamabad were nominated for inspection of aforesaid manufacturer. The panel conducted inspection on 25th & 26th May, 2015 and submitted the report.

The applicant firm submitted the documents in registration application dossier including Form 5-A, ISO 13485 certificate, EC certificate (Production Quality Assurance), Credential of manufacturer abroad, Free Sale Certificate issued by SFDA, China and letter of authorization claiming M/s Sumbow Medical Instruments Co., Ltd, 16F Chengtou Building, No.68 Heji Street, Jiangdong District, China as the manufacturer of the applied products. The inspection letter was also issued with aforesaid manufacturer’s name and address but in the inspection report manufacturer name was not clear and site address was also different. The name and address of manufacturer in the inspection report was mentioned as M/s Sumbow Medical Instruments Co. Ltd, Jiangsu Webest Medical Product Co. Ltd, No.5, Yingchun Road, Industrial Park, Xuyi, Jiangsu, China. In the inspection report the address “16F Chengtou Building, No.68 Heji Street,

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Jiangdong” is shown as postal address. Furthermore, all the documents attached with the inspection report including copy of Free Sale Certificate, copies of bill of lading, stability study data and other documents written in Chinese language have been stamped by M/s Jiangsu Webest Medical Product Co. Ltd. The panel recommended the above products for registration. In this regard both panel members were requested to clarify regarding status of manufacturer. Both the members of panel have submitted as under:-

Mr. Khalid Mahmood, FID-II, DRAP, Islamabad. “You have desired to clarify that in the inspection report manufacturers name is not clear and site address is also different for M/s Sumbow Medical Instruments Co., Limited, China. I have already clarified that there are number of firms working in the China in the name and style of Sumbow Medical Instruments, China and the one we have visited for inspection was Sumbow Medical Instruments. It was further clarified that the Division of Medical Devices and Medicated Cosmetics need to go by the book. The firm which we have inspected submitted the report accordingly (The report is submitted by Dr. Sheikh Akhter Hussain from Lahore). Further it is necessary to clarify that the credentials already submitted by M/s Sumbow Medical Instruments Company Limited, China through its importer M/s B.N.S Trading Est, Lahore needs to be matched and if some anomalies are found then the case may be decided as per prevailing law/SOPs etc. It is further clarified that the report is submitted in accordance with the tour arranged by the importers of Pakistan from China and the panel is not conversant with the geographical limits of provinces in China. The panel submitted the reports in accordance with the facilities visited and provided with the names of their sites/cities/provinces in China and no facts have been concealed in writing the reports that is why you may be experiencing in variation of documents/information submitted by M/s B.N.S. Trading Est, Lahore. It is therefore again requested that the report is submitted in accordance with the Manufacturer got visited by the importer to us. The copies of pictures of the plant addresses, disposable packs are attached for your further necessary action as per law. Any further clarification may be solicited if desired so and the firm M/s B.N.S.Trading Est, Lahore may also be intimated as may be the exporter name is M/s Sumbow Medical Instruments Limited, China.”

Dr. Sheikh Akhter Hussain, DDG, DRAP, Lahore. “It is to inform you that name and address of the manufacturer has been misinterpreted by considering two different names as one, as “M/s Sumbow Medical Instrument Co., Limited, Jiangsu Webest Medical Product Co., Ltd, No.5, Yingchum Road, Industrial Park, Xuyi, Jiangsu, China”. The factual position with regard to name and addresses of these two concerns is clarified that M/s Jingsu Webest Medical Product Co., Ltd., No.5, Yingchum Road, Industrial Park, Xuyi, Jiangsu, China is the manufacturer and M/s Sumbow Medical Instruments Co., Ltd., is a sister concern, hence referred to documents, attached with the inspection report, have been stamped by the manufacturer. A copy of the certificate, dated 11-03-2014, signed by the manufacturer as well as sister concern thereof, which is self-explanatory with respect to status of both

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the said concerns, is attached herewith for further clarification in this regard. It would not be out of place to mention here that the inspection report submitted by the nominated panel is based on facts observed by it during the inspection/visit.”

Furthermore, the certificate by the manufacturer and exporter attached with the clarification, is reproduced as under:- “It is certified that M/s Sumbow Medical Instruments Co., Add:16F, Chengtou Building, No.68 Heji Street, Jiangdong District, Ningbo 315041 China is a sister concern of M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China. All the goods supplied, distributed and exported are manufactured by M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China. Registered office of M/s Sumbow Medical Instruments Co is 16F, Chengtou Building No.68 Heji Street, Jiangdong District, Ningbo 315041 China and manufacturing site with the name of M/s Jiangsu Webest Medical Products Co., Ltd located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China. The products manufactured by M/s Jiangsu Webest Medical Products Co., Ltd, located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China are exported to Pakistan through the sole rights of M/s Sumbow Medical Instruments Co., is 16F, Chengtou Building No.68 Heji Street, Jiangdong District, Ningbo 315041 China.”

Decision: Deferred for discussion in the next meeting.

Case No.02: Change of Address of Legal Manufacturer and Name of Manufacturing Site.

The Registration Board in its 242nd meeting held on 24th and 25th February, 2014 considered and approved the following medical devices of M/s. Ferozsons Laboratories Limited, Nowshera subject to inspection of manufacturer abroad, verification of storage facilities etc as per policy:-

S.# Name of Importer and Name of Drug (s) Demanded Shelf Manufacturer/Exporter Composition & Price & Pack Life Therapeutic Group Size 1. M/s. Ferozsons Laboratories Limited, Promus Premier TM Decontrolled 18 P.O. Ferozsons, Amangarh, Nowshera. Monorail TM Everolimus- till policy months Eluting Platinum decision by the Legal Manufacturer Chromium Coronary Stent Federal M/s. Boston Scientific Corporation, System Government One Boston Scientific Place, Natick. MA 01760-1537, USA Stent Dia (mm): 2.25, 1’s 2.50, 2.75, 3.00, 3.50, 4.00. Manufacturing Site M/s Boston Scientific Ireland Ltd, Stent Length (mm): 8, Ballybrit Business Park, Galway, 12, 16, 20, 24, 28, 32, 38. Ireland.

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Now the firm has informed that address of the owner/operator and name of the manufacturing site has been changed as follows:- Applied in the Dossier Proposed changes for approval Legal Manufacturer: Owner/ Operator: M/s. Boston Scientific Corporation, One Boston M/s. Boston Scientific Corporation, 300 Boston Scientific Place, Natick. MA 01760-1537, USA. Scientific Way, Marlborough, MA 01752, USA.

Manufacturing Site: Manufacturing Site: M/s Boston Scientific Ireland Ltd, M/s Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland Ballybrit Business Park, Galway, Ireland

The firm has provided following documents in support of above changes and requested for approval of above mentioned changes before issuance of registration letter. (i) Original Free Sale Certificate issued by US,FDA attested by Embassy of Pakistan. (ii) Free ale Certificate issued by Health Product Regulatory Authority, Ireland. (iii) Letter from notified body DEKRA. (iv) New EC Certificate (Full Quality System Certificate) issued by DEKRA .

Decision: The Registration Board approved above mentioned new address of the owner/operator and new name of the manufacturing site of already approved product (approved in 242nd meeting). The registration certificate shall be issued with new address of the owner/operator and new name of the manufacturing site.

Case No.03: Request for Permission of Printing Registration Number, Manufacturing date, Expiry date, MRP and Urdu version

M/s Universal Enterprises, Karachi requested for permission of printing Registration Number, manufacturing date, expiry date, MRP and Urdu version from Mission Pharmaceutical, Karachi (Manufacturing Licence No. 000809) on their already registered following imported medical devices i.e.Terumo Syringes manufactured by Terumo (Phillipines) Corporation, Laguna, Phillipines:- S.No. Regn. No. Name of Medical Device (s) 1. 062230 Terumo 3cc Syringe 2. 062231 Terumo 5cc Syringe 3. 062232 Terumo 10cc Syringe 4. 062233 Terumo 20cc Syringe 5. 062234 Terumo 30cc Syringe

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The firm has informed that the manufacturer has been producing the syringes in bulk quantities and huge batches, according to their cyclical system. For small quantities like ours, they have to make special arrangements for breaking the cycle, which is not only time consuming but also capital intensive issue. They are coping with us on their very special request with the interval of 3-4 months. The manufacturer has informed the importing firm that this arrangement will not be available in the coming months because of this special arrangements, they have to break the cycle for printing purposes just for a small quantities, creating hurdles for them resulting delay of the other orders in bulk quantities and as a result incurred financial losses which is not acceptable for them. In this regard, finally the principal manufacturer has given them a deadline of December, 2015 to have some alternate arrangements for printing otherwise they are unable to continue their supplies. Firm has further informed that they have made agreement with Mission Pharmaceutical, Karachi wherein Mission Pharmaceutical is agreed to provide service of aforesaid printing matter on their imported syringes. The firm Universal Enterprises has also submitted that they will follow all the rules and regulations of DRAP including labeling rules before marketing of Terumo Syringes. The firm has submitted the following documents:- (i) Fee challan of Rs.5000/- for each product. (ii) Number of consignment imported from the time of registration uptil now and quantity of each size imported. (iii) Samples of Syringes. (iv) Copy of Drug Sale License. (v) Copy of manufacturing license of Mission Pharmaceutical Pvt. Ltd, Karachi. (vi) MoU between Universal Enterprises and M/s Mission Pharmaceutical, Karachi.

Decision: Deferred for discussion in the next meeting.

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Item No.VII: Data Authenticity for New Chemical Entities / New Drugs.

Registration Board in 253rd meeting approved 14 registration applications for local manufacturing of sofosbuvir 400mg tablets. Later on, a complaint was lodged by local pharmaceutical manufacturers regarding illicit / irregular importation of drug substance and submission of fake data by some manufacturers for grant of registration in 253rd meeting of registration Board.

To discuss above issues, a meeting was held on 28th October, 2015 under the Chair of the Minister of State for NHS,R&C to ensure availability of safe, effective and quality Sofosbuvir. During meeting, it was apprised that data evaluation for registration of sofosbuvir 400 mg tablet was based on the submitted documents reviewed by registration section only and detailed on site verification and authentication of data was not done, as it is not carried out in routine.

After detailed discussion, following was decided:

 To direct DRAP to take notice of this matter and to conduct detailed investigation on site to confirm the quality parameters and legal status and authenticity of Sofosbuvir drug substance / finished product (as the case may be), GMP certificate / approval of the manufacturing of the drug substance API or finished goods, by the regulatory authority of the country and its drug substance importation for evaluation studies under local regulatory compliance.

 In addition, being a first of its kind, registration of a generic of a new drug, applied since last year, DRAP is further directed to investigate thoroughly the genuineness of the submitted data in the product registration dossier by the firms through "onsite investigation and inspection" for quality, specification, test analysis, facilities, especially for the stability data, of all the applicant firms, before grant of registration letters.

 Such procedure for onsite investigation for the genuineness of submitted data should be adopted in future, for all applications of generics of NCEs (New Chemical entities I New drugs generic versions) where local long term data and experience is not available, to ascertain quality, safety and efficacy profile of such drugs, in the larger public interest.

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Above decision has been communicated by Ministry of National Health Services, Regulation & Coordination vide letter No. F. 3-71/2015-DRAP/NHSR&C dated 06.11.2015.

Decision: Keeping in view above recommendations / directions, Registration Board constituted a three members panel to investigate the authenticity/genuineness of data (import of raw material and stability data submitted for registration). The composition of the panel is as follows: Brig (R) Muzammil H Najmi Chairman Dr.Saif-ur-Rehman Khattak, FGA, CDL,DRAP Member Dr.Obaidullah, DDG (R.I), DRAP Member/Secretary

Registration Board deferred remaining agenda due to paucity of time.

Meeting ended with a vote of thanks to and from the chair. End of Document ******************************************************************************

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