Letters for Issue on 27.06.2014

LETTERS FOR ISSUE ON 27.06.2014 BE NOC FOR EXPORT

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

1. M/s. Apotex Research Pvt. Ltd., 21538 Approval Letter Bangalore-560 099

4. M/s. Cliantha Research Limited, 13099 Approval Letter Ahmedabad-380 054

5. M/s. Cliantha Research Limited, 25113 Approval Letter Ahmedabad-380 054

6. M/s. Famy Care Ltd., Mumbai-400 001 21407 Clarification Letter

7. M/s. GVK Biosciences Pvt. Ltd., 21511 Approval Letter Ahmedabad-380 051

8. M/s. Lambda Therapeutic Research Ltd., 20869 Clarification Ahmedabad-380 061 Letter

9. M/s. Lupin Bioresearch Center, Pune-411 22497 Approval Letter 021

10. M/s. QPS Bioserve India Pvt. Ltd., 11277 Approval Letter Hyderabad – 500 037

11. M/s. RA Chem Pharma Ltd., Balanagar, 23516 Amendment Hyderabad-500 037 Letter

12. M/s. Sitec Labs Pvt Ltd, Navi Mumbai- 21996 Approval Letter 400701 13. M/s. Sitec Labs Pvt Ltd, Navi Mumbai- 23046 Approval Letter 400701

14. M/s. Torrent Pharmaceuticals Ltd. 21493 Approval Letter (Research Centre), Gujarat

ONLY TEST LICENCE FOR BE

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

1. M/s. Accutest Research Laboratories (I) Pvt. 22427 Test Licence Ltd., Navi Mumbai-400 709

2. M/s. Apotex Research Pvt. Ltd., Bangalore-560 21537 Test Licence 099

3. M/s. Azidus Laboratories Ltd., Chennai-600 048 23150 Test Licence

4. M/s. Azidus Laboratories Ltd., Chennai-600 048 23149 Test Licence

5. M/s. Lambda Therapeutic Research Ltd., 22553 Test Licence Ahmedabad-380 061

6. M/s. Unichem Laboratories Ltd., Mumbai-400 21555 Test Licence 102

TEST LICENCES

S. No. Name of the Company Diary No. Type of Letter

1. AET Laboratories Ltd 23525, Approval Letter 34700

2. Agila Specialties Pvt. Ltd 23387, Approval Letter 34772

3. Agila Specialties Pvt. Ltd 23388, Approval Letter 34771

4. Alkem Laboratories Ltd 23482, Approval Letter 34908

5. BDR Pharmaceuticals 23340, Approval Letter International Pvt. Ltd 34896

6. Cadila Pharmaceutical Limited 23361, Approval Letter 34892

7. Centaur Pharmaceuticals Pvt 23526, Approval Letter Ltd 34726

8. Cipla Ltd 23480, Approval Letter 34709

9. Cipla Ltd 23481, Approval Letter 34707

10. Glenmark Pharmaceuticals Ltd 23537, Approval Letter 34696

11. Glenmark Pharmaceuticals Ltd 23539, Approval Letter 34695

12. Johnson and Johnson Ltd 23389, Approval Letter 34762

13. Johnson and Johnson Ltd 23390, Approval Letter 34761

14. Macleods Pharmaceuticals Ltd 23333, Approval Letter 34884

17. Onco Therapies Ltd 23386, Approval Letter 34887

18. Sharon BioMedicine Ltd 23524, Approval Letter 34701 19. Sun Pharmaceutical Industries 23336, Approval Letter Ltd 34905

20. Sun Pharmaceutical Industries 23337, Approval Letter Ltd 34903

21. Sun Pharmaceutical Industries 23338, Approval Letter Ltd 34909

22. Tevapharm India Pvt Ltd 23503, Approval Letter 34894

34. Tevapharm India Pvt Ltd 23515 Approval Letter 35. Tevapharm India Pvt Ltd 23527, Approval Letter 34816

39. Wockhardt Ltd 23327, Approval Letter 34653

FDC DIVISION

S.NO NAME OF COMPANY DIARY DOCUMENT . NO 1. M/s. Torrent Pharmaceuticals Pvt. Ltd., 15116 Letter

2. M/s. Biodeal Pharmaceuticals Pvt. Ltd., 82926 Clarification Letter

3. M/s. Olive Healthcare 41615 Clarification Letter

4. M/s. Bajaj Healthcare Ltd., 26113 Clarification Letter

5. M/s. Indi Pharma Pvt. Ltd., 41774 Clarification Letter

NEW DRUG

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. M/s. MSN Labs - Approval Letter

2. M/s. Akums Drugs - Clarification Letter

MEDICAL DEVICE

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Lepu Medical Technology (Beijing) Co. Ltd. 23484 Approval (F-RC)

2. M/s. Covidien Healthcare India Pvt. Ltd. 5425 Approval (E-RC)

3. M/s. Biotronik Medical Devices India Pvt. Ltd. 18129 Approval (R-IL)

4. M/s. Meril Healthcare Pvt. Ltd. 19448 Approval (R-IL)

5. M/s. Biomed Orthopaedics India Pvt. Ltd. 19452 Approval (E-IL)

6. M/s. Apothecaries Pvt. Ltd. 16777 Approval Letter

7. The State Drugs Controller, Haryana (CLAA) FTS-32263 Approval Letter

The Deputy Drugs Controller (I), Ghaziabad (CLAA)

(M/s. La-Med Healthcare Pvt. Ltd.)

DIAGNOSTIC DIVISION

S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Euro Diagnostics Systems Pvt. Ltd. 18957 Approval (IL)

2. M/s. Globe Bio-Medicals. 19113 Approval (IL)

3. M/s. Randox Laboratories (India) Pvt. Ltd. 20330 Approval (E-IL)

VACCINE DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s GSK Pharmaceuticals ltd 11284, 12197 Approval Letter

2 M/s Sanofi Pasteur India Pvt, 12443 Approval Letter Ltd

3 M/s Stallen South Asia Pvt, 20211, Approval Letter ltd

4 M/s EliLilly and company 18716 Clarification Letter (india) Pvt, ltd

5 M/s Bharat Biotech 7622 Approval Letter International ltd

6 M/s Intas Pharmaceuticals 18368 Clarification Letter Ltd

7 M/s Roche Product India Pvt, 15475 Clarification Letter ltd 8 M/s Shantha Bioethics Ltd Clarification Letter

BIOLOGICAL DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s Biocon ltd 22331, 12995 (fts Approval, Clarification no) Letter,

2 M/s Mabpharma ltd 21903 Clarification Letter

COSMETICS DIVISION

S.N COMPANY NAME DIARY NO STATUS O.

1. M/s. Wockhardt Limited, Mumbai 15932 Deficiency Letter

2. M/s. New Beauty Center, Mumbai 17456 Deficiency Letter

3. M/s. Priss Trading Company, Ernakulum 13701 Approval Letter

4. M/s. Hindustan Uniliver Limited, Mumbai 18448 Approval Letter