LETTERS FOR ISSUE ON 27.08.2014 BE NOC FOR EXPORT

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

1. M/s. Cipla Limited, Mumbai-400 008 31281 Clarification Letter

2. M/s. Cipla Limited, Mumbai-400 008 31282 Clarification Letter

3. M/s. Famy Care Ltd., Mumbai-400 001 32505 Amendment Letter

4. M/s. Jubilant Life Sciences Ltd, Noida, 15078 Amendment 201301, UP Letter

5. M/s. Lupin Bioresearch Center, Pune-411 32759 Approval Letter 021

6. M/s. Lupin Bioresearch Center, Pune-411 22673 Approval Letter 021

7. M/s. Macleods Pharmaceuticals Ltd., 30315 Clarification Andheri (East), Mumbai-400 059 Letter

8. M/s. Micro Therapeutic Research Labs 22170 Amendment Pvt. Ltd., Chennai-600 059 Letter

9. M/s. Mylan Laboratories Limited, 28555 Amendment Secunderabad Letter

10. M/s. Ranbaxy Laboratories Ltd., New 32010 Approval Letter Delhi-110 019

11. M/s. Sun Pharmaceutical Industries Ltd., 29477 Amendment Vadodara-390 020 Letter

12. M/s. Sun Pharmaceutical Industries Ltd., 32016 Amendment Vadodara-390 020 Letter

13. M/s. Veeda Clinical Research Pvt. Ltd., 11168 Rejection Letter Ahmedabad-380 015 ONLY TEST LICENCE FOR BE

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

1. M/s. Azidus Laboratories Ltd., Chennai-600 17445 Test Licence 048

2. M/s. Kusum Healthcare Pvt. Ltd., New Delhi- 28828 Test Licence 110 020

3. M/s. Sun Pharmaceutical Industries Ltd., 29913 Test Licence Vadodara-390 020

GLOBAL CLINICAL TRIAL

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

1. M/s. Novartis 21344/28179 Clarification Letter/Change in PI Approval

2. M/s. Kendle 30599 Clarification Letter

3. M/s. MSD 31179 Clarification Letter

4. M/s. YRG 22279/22280 Clarification Letter

VACCINE DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s Bharat Biotech 30072 Clarification letter International Ltd

2 M/s Serum Institute of India 31023 Continuation letter Limited 3 M/s Biocon Ltd 58334 Approval Letter

4 M/s Zoetis India Ltd 29430 Amendment Letter

5 M/s Johnson & Johnson Ltd 29914 Approval Letter

6 M/s Duraent Biological Ltd 26751 Approval Letter

7 M/s G.C Chemie Ltd 24990 Cancellation Letter

8 M/s Lupin Ltd 64145 Approval Letter

9 M/s Intas Pharmaceuticals ltd 26907 Clarification letter

BIOLOGICAL DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s Sun Pharmacuetical 17677 Approval Letter Industries Ltd

2 M/s Unimed Technologies Ltd 442 Approval Letter

3 M/s Bharat Serum and 29578 Amendment Letter Vaccine Ltd

TEST LICENCES

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

1. Aizant Drug Research Solutions 33159, Approval Letter Pvt. Ltd 48809

2. Aizant Drug Research Solutions 33160, Approval Letter Pvt. Ltd 48768

3. Aizant Drug Research Solutions 33172, Approval Letter Pvt. Ltd 48927

4. Aizant Drug Research Solutions 33173, Approval Letter Pvt. Ltd 48923

5. Alkem Laboratories Ltd 31698, Approval Letter 46546, 35437, 52143

6. APL Research Centre 33188, Approval Letter 48993

7. APL Research Centre 33189, Approval Letter 48986

8. APL Research Centre 33190, Approval Letter 49000

9. APL Research Centre 33191, Approval Letter 49012

10. APL Research Centre 33195, Approval Letter 49006

11. Cadila Healthcare Limited 33229, Approval Letter 48880

12. Indoco Remedies Ltd 33240, Approval Letter 48891

13. Indoco Remedies Ltd 33241, Approval Letter 48895

14. Indoco Remedies Ltd 33242, Approval Letter 48899

15. Indoco Remedies Ltd 33243, Approval Letter 48913

16. Indoco Remedies Ltd 33244, Approval Letter 48918

17. Indoco Remedies Ltd 33245, Approval Letter 48920

18. Indoco Remedies Ltd 33246, Approval Letter 48909

19. Indoco Remedies Ltd 29712, Approval Letter 43809, 35107, 51766

20. Indoco Remedies Ltd 29714, Approval Letter 43703, 35108, 51764

21. Indoco Remedies Ltd 29715, Approval Letter 43704, 35109, 51769

22. Jubilant Generics Ltd 29626, Approval Letter 43698, 33249, 48685

23. Jubilant Generics Ltd 30512, Approval Letter 45090, 35285, 51870

24. Jubilant Generics Ltd 30513, Approval Letter 45096, 35285, 51870

25. Jubilant Generics Ltd 30731, Approval Letter 45948, 35285, 51870

26. MSN Laboratories Pvt Ltd 28856, Approval Letter 42852, 34384, 50610

27. Perrigo Laboratories India Pvt 33161, Approval Letter Ltd 48756

28. Perrigo Laboratories India Pvt 33162, Approval Letter Ltd 48762

29. Piramal Enterprises Ltd 33248, Approval Letter 48690

30. Precise Chemipharma Pvt. Ltd 33163, Approval Letter 48958

31. Swati Spentose Pvt. Ltd 33228, Approval Letter 48828

32. Syngene International Ltd 26855, Approval Letter 39640, 31772, 47028

33. Torrent Pharmaceuticals Ltd 33174, Approval Letter 48955

34. Vimta Labs Ltd 29474, Approval Letter 43497, 35290, 52123

35. Vimta Labs Ltd 29663, Approval Letter 43705, 35290, 52123

36. Wintac Ltd 31428, Approval Letter 46440, 35710, 52545

37. Wockhardt Ltd 23379, Approval Letter 34869, 30308, 44712, 33812, 49691

38. Wyeth Ltd 31645, Approval Letter 46647, 35629, 52468

39. Resonance Labopratories Pvt 35409, Amendment Ltd 52067

40. Cipla Ltd 35155, Amendment 51413

41. Mylan Laboratories Ltd 34755, Amendment 50916

42. Sun Pharmaceutical Industries 34784, Amendment Ltd 50980

43. Sun Pharmaceutical Industries 34775, Amendment Ltd 51155

44. Cadila Healthcare Ltd 34642, Amendment 50947

45. Vimta Labs Ltd 32193, Deficiency 47510 Letter

46. Unique Laboratories Ltd 32437, Deficiency 47677 Letter

47. Encube Ethicals Pvt Ltd 32438, Deficiency 47661, Letter 32439, 47667

48. Takeda Pharmaceuticals India 32932, Deficiency Pvt Ltd 48499, Letter 32931, 48496

49. Mylan Laboratories Ltd 33108, Deficiency 48741 Letter

50. Tevapharm India Pvt Ltd 28188, Approval Letter 41543

LETTER PERTAINING TO REGISTRAION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. AMBALAL SARABHAI 33104 APPROVAL LETTER ENTERPRISES LTD. 2. GSK PHARMACEUTICALS LTD. 22121 Clarification Letter

LETTER PERTAINING TO IMPORT

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. ALKEM LABORATORIES LTD. 33522 Clarification Letter 2. VENUS REMEDIES LTD. NIL Clarification Letter 3. EMCURE PHARMACEUTICAL 26013 Clarification Letter LTD. 4. BIOTAVIA LABS LTD. 32188 Clarification Letter

COSMETICS DIVISION

S.N COMPANY NAME DIARY NO STATUS O.

1. M/s. Argus cosmetics Limited Tamil Nadu 26977 Deficiency Letter

2. M/s. Total Exports, Mumbai 28064 Deficiency Letter

3. M/s. Jafra Ruchi Cosmetics India Pvt. Ltd., New 20949, Approval Letter Delhi 21045