Letters for Issue on 05.02.2015

LETTERS FOR ISSUE ON 05.02.2015 BE NOC FOR EXPORT

S. NAME OF THE COMPANY REF. NO. Type of letter NO.

1. M/s. Apotex Research Pvt. Ltd., 48394 Approval Letter Bangalore-560 099 2. M/s. Cipla Limited, Mumbai-400 008 137 Clarification Letter 3. M/s. Cliantha Research Limited, 2813 Approval Letter Ahmedabad-380 054 4. M/s. Cliantha Research Limited, 545 Test Licence Ahmedabad-380 054 5. M/s. Dr. Reddy’s Laboratories Ltd., 811 Test Licence Hyderabad-500 034 6. M/s. Emcure Pharmaceuticals Limited, 564 Approval Letter Pune-411 026 7. M/s. Hetero Labs Ltd., Hyderabad-500 018 306 Approval Letter

8. M/s. Lambda Therapeutic Research Ltd., 756 Approval Letter Ahmedabad-380 061 9. M/s. Lupin Limited (Research Park), Pune- 354 Approval Letter 412 115 10 M/s. Lupin Limited (Research Park), Pune- 515 Approval Letter . 412 115

11 M/s. Macleods Pharmaceuticals Ltd., 330 Approval Letter . Andheri (East), Mumbai-400 059

12 M/s. Macleods Pharmaceuticals Ltd., 29509 Approval Letter . Andheri (East), Mumbai-400 059

13 M/s. Manipal Acunova Ltd., Bangalore- 490 Clarification . 560 066 Letter 14 M/s. QPS Bioserve India Pvt. Ltd., 572 Test Licence . Hyderabad – 500 037

15 M/s. Reliance Life Sciences Pvt. Ltd., Navi 47949 Additional Study . Mumbai-400 701 Centre

16 M/s. Sipra Labs Limited, Hyderabad-500 474 Test Licence . 018

17 M/s. Veeda Clinical Research Pvt. Ltd., 412 Test Licence . Ahmedabad-380 015

18 M/s. Panexcell Clinical Lab Pvt. Ltd., Navi 2736 Approval Letter . Mumbai-400 701

WRITTEN CONFIRMATION

S. No Firm Name Type of Letter 1. Lupin Ltd., 198-202, New Industrial Area No.2, WC Cirtificate Raisan, M.P.

REGISRATION

S.NO. NAME OF DIARY NO. TYPE OF APPLICANT LETTER 1. CHANDRA BHAGAT 45724,46621 02 PHARMA PVT. LTD. CLARIFICATION LETTER 2. A.MENARININ INDIA 45336 CLARIFICATION PVT.LTD. LETTER 3. PFIZER LTD. 37530 CLARIFICATION LETTER

FDC DIVISION S.NO. NAME OF COMPANY DIARY NO DOCUMENT

1. M/s. Verizon Genesis 73889 Letter

SUBSEQUENT NEW DRUG

S. NAME OF THE REFERENCE FTS NO. TYPE OF NO. FIRM NO. LETTER 1. M/s Cliantha Research 49880 75301 Query Letter Ltd., 2. M/s Bharat Serums and - - Query Letter Vaccines Limited., 3. M/s Erawat Pharma 31403 46368 Query Letter Ltd., 4. M/s Allergan India 50253 - CT NOC Letter Pvt., Ltd.,

GLOBAL CLINICAL TRIAL

Sr. Name of Firm Reference No. Type of Letter No.

1. M/s. Novartis 50268/51123 Change in PI & new sites approval Letter 2. M/s. PPD 49921 Clarification Letter 3. M/s. Maya Clinicals - Clarification Letter

BA/BE DIVISION

S. NO. COMPANY NAME FTS NO. /Diary STATUS No.

01 M/s. Synchron Research Services 21073 Approval Pvt Ltd., Gujarat 02 M/s. Quantimmune Solutions Pvt. 1134 Amendment Ltd., Mumbai 03 M/s. CLINOGENT Division of 2673 Withdrawal GVK Biosciences Pvt. Ltd., Hyderabad

LVP DIVISION

S. NO. COMPANY NAME FTS NO. /Diary STATUS No.

01 M/s. Denis Chem Lab Ltd., Gujarat 76521, 76520 Approval

02 M/s. Abaris Healthcare, Gujarat 75874, 75875, Approval 75870, 75873 03 M/s. Cadila Healthcare Ltd., C/o. 477 Approval M/s. Nirma Ltd., Gujarat 04 M/s. EuroLife Healthcare, 802 Approval Uttarakhand

MEDICAL DEVICE DIVISION

S.NO COMPANY NAME DIARY STATUS . NO

1. M/s. Macopharma India Transfusion Solutions 49864 Test License Pvt. Ltd., New Delhi 2. M/s. Hereaus Technologies India pvt. Ltd., 48165 Query Letter Gurgaon 3. M/s. Hereaus Technologies India pvt. Ltd., 48166 Query Letter Gurgaon 4. M/s. Hereaus Technologies India pvt. Ltd., 39607 Query Letter Gurgaon 5. M/s. Merit Medical Systems India Pvt. Ltd., 40065 Query Letter Bangalore 6. M/s. Abbott Healthcare Pvt. Ltd., Mumbai 43236 Query Letter 7. M/s. Piramal Healthcare Ltd., Mumbai 44741 Query Letter 8. M/s. Boston Scientific India pvt. Ltd., New 46383 Query Letter Delhi 9. M/s. Surya Surgical Industries, Chennai 42392 Query Letter 10. M/s. Johnson & Johnson Ltd., Bhiwandi 44287 Query Letter 11. M/s. B.Braun Medical India Pvt. Ltd., 47643 Query Letter Bhiwandi 12. M/s. Devon Innovations Pvt. Ltd., Bangalore 18238 Query Letter 13. M/s. Biomet Orthopaedics India pvt. Ltd., 49553 Query Letter Ahmedabad 14. M/s. KCI Medical India Pvt Ltd., Bangalore 39514 Query Letter 15. M/s. Shah Distributors, Bangalore 46650 Query Letter 16. M/s. Zimmer India Pvt. Ltd., 27312 Query Letter 17. M/s. Well Tech Imports and Exports Pvt. Ltd., 58313 Query Letter Vellore 18. M/s. Duraant Biologicals Ltd., Hyderabad 18317 Query Letter 19. M/s. Boston Scientific India pvt. Ltd., New 48368 Query Letter Delhi 20. M/s. ST. Jude Medical India Pvt. Ltd., 42526 Query Letter Hyderabad 21. M/s. Johnson & Johnson Ltd., Bhiwandi 38045 Query Letter 22. M/s. Mediplus (India) Ltd., Bahadurgarh/ SLA FTS no. Approval Letter Panchkula 75412 23. M/s. Meril Healthcare Pvt. Ltd., Vapi / FDA FTS no. Approval Letter Gandhinagar 72513 24. M/s. Bio-med Health Care product Pvt.Ltd., FTS no. Approval Letter Haridwar / SLA Dehradun 58523 25. M/s. TTK Healthcare Ltd., Chennai/ SLA FTS no. Approval Letter Chennai 75898

DIAGNOSTICS DIVISION

S.NO COMPANY NAME DIARY STATUS . NO

1. M/s. Beckman Coulter India Pvt. Ltd., 50781 Query Letter Mumbai 2. M/s. Qiagen India (P) Ltd., New Delhi 50471 F-10 3. M/s. Roche Diagnostics India Pvt. Ltd., 46061 F-10 Mumbai 4. M/s. Roche Diagnostics India Pvt. Ltd., 49072 E-F-10 Mumbai 5. M/s. Microgene Diagnostics Systems Pvt. Ltd., 48685 Query Letter Delhi 6. M/s.. Oscar Medicare Pvt. Ltd., Delhi 49149 Query Letter 7. M/s. Abbott Healthcare Pvt. Ltd., Mumbai 49904 Query Letter 8. M/s. Rapid Diagnostics, Delhi 32679 F-10 9. M/s. Diasys Diagnostics India Pvt. Ltd., 46365 F-10 Chennai 10. M/s. Ypsomed India Pvt. Ltd., New Delhi 48211 E-F-10 11. M/s. Arkray Healthcare Pvt. Ltd., Mumbai 50733 Query Letter

VACCINE DIVISION S. No. COMPANY NAME Dy. No. STATUS

1 M/s Bio Vaccine India Pvt, 20549 Approval letter Ltd 2 M/s Synergy Diagnostics Approval letter Limited 3 M/s Paviour Pharmaceuticals Approval letter Pvt, Ltd 4 M/s Biocon ltd Clarification Letter

5 M/s Virchow Biotech Pvt, ltd Clarification Letter

6 M/s Manipal Acunova ltd Clarification Letter

7 M/s Premium Serums & 72476 Approval letter Vaccine Pvt. Ltd

SEC MEETING LETTER

S. No. COMPANY NAME Dy. No. STATUS

1 M/s Sanofi Pasteur India Pvt, Invitation letter ltd 2 M/s Bharat Biotech Invitation letter International ltd 3 M/s Cadila Pharmaceutical ltd Invitation letter

4 M/s Sinopharma India Pvt, ltd Invitation letter 5 M/s Human Biological Institute Invitation letter

6 M/s Novartis Healthcare Pvt, Invitation letter ltd 7 M/s Synergy Diagnostics Invitation letter

8 M/s Dr. Reddy Laboratories Invitation letter Ltd 9 M/s FDC ltd Invitation letter

10 M/s GSK Pharmaceutical ltd Invitation letter