Letters for Issue on 31.07.2014

LETTERS FOR ISSUE ON 31.07.2014

VACCINE DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s India Immunologicals Ltd 29390 Approval Letter

2 M/s Torrent Pharmaceuticals 25012, 25011 Clarification letter Ltd

3 M/s Vins Bioproducts Ltd Clarification letter

4 M/s Sanofi Pasteur India Pvt, 18933, 19741 Approval Letter Ltd

6 M/s Shreya Life Sciences Pvt, 20867 Clarification letter ltd

7 M/s Sandor Medicaids Pvt, ltd 41315 (fts no) Approval Letter

8 M/s Wockhardt Ltd 26418 Approval Letter

9 M/s Intervet India pvt, ltd 16038, 15265 Approval Letter

BIOLOGICAL DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s USV Ltd 22353, 22352 Approval Letter & Clarification Letter

2 M/s Reliance Life Sciences Pvt, 5460 Approval Letter ltd

3 M/s Lupin Ltd 2057, 21480, 32147 Approval & Clarification Letter

4 M/s Virchow Biotech Pvt, ltd 21480 Clarification Letter

5 M/s Baxter (India) Pvt, ltd Approval Letter

6 M/s Alpha Drugs 11889 Clarification letter

LVP DIVISION

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

01 M/s. Claris Lifesciences C/o M/s. 43187 Approval Claris Otsuka, Gujarat

02 M/s. Claris Lifesciences, Gujarat 34634 Approval

03 M/s. Gland Pharma Ltd., Hyderabad 42642 Query

04 M/s. Denis Chem Lab, Gandhinagar 38761 Query

05 M/s. Unique Pharma, Gujarat 40701 Approval

SUBSEQUENT NEW DRUG S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO. 1. M/s Intas 12669 19647 Deficiency Letter Pharmaceuticals Ltd.,

BE NOC FOR EXPORT

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

1. M/s. APL Research Center, Hyderabad- 25565 Clarification 500 090 Letter

2. M/s. Azidus Laboratories Ltd., Chennai- 26351 Clarification 600 048 Letter

3. M/s. Sun Pharmaceutical Industries Ltd., 18125 Clarification Vadodara-390 020 Letter

4. M/s. Watson Pharma Pvt. Ltd., Navi 26448 Clarification Mumbai-400 614 Letter

5. M/s. Watson Pharma Pvt. Ltd., Navi 25729 Clarification Mumbai-400 614 Letter

TEST LICENCES

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

1. Agila Specialties Pvt Ltd 29835, Approval Letter 44282

2. APL Research Centre 30037, Approval Letter 44304

3. APL Research Centre 30036, Approval Letter 44306

4. Centaur Pharmaceuticals Pvt 29821, Approval Letter Ltd 44295

5. Centaur Phartmaceuticals Pvt 29820, Approval Letter Ltd 44296

6. Dr. Reddy’s Laboratories Ltd 29921, Approval Letter 44388

10. Emcure Pharmaceuticals Ltd 29965, Approval Letter 44316

11. Emcure Pharmaceuticals Ltd 29966, Approval Letter 44315

12. Famy Care Ltd 29847, Approval Letter 44272

13. Glenmark Generics Ltd 29769, Approval Letter 43874

14. Glenmark Generics Ltd 29768, Approval Letter 43875

15. Glenmark Pharmaceuticals Ltd 29766, Approval Letter 43877

18. Glenmark Pharmaceuticals Ltd 29765, Approval Letter 43878 19. Indeus Life Sciences Pvt Ltd 29658, Approval Letter 43850

20. Intas Pharmaceuticals Ltd 29870, Approval Letter 44275

23. Inventia Healthcare Pvt. Ltd 29879, Approval Letter 44234

24. Inventia Healthcare Pvt. Ltd 29880, Approval Letter 44236

25. Johnson & Johnson Pvt. Ltd. 29916, Approval Letter 44224

26. Johnson & Johnson Pvt. Ltd. 29917, Approval Letter 44225

27. Jubilant Generics Ltd 29929, Approval Letter 44377

28. Macleods Pharmaceuticals Ltd 29868, Approval Letter 44253

29. Macleods Pharmaceuticals Ltd. 29867, Approval Letter 44219

30. MSN Laboratories Pvt Ltd 29848, Approval Letter 44263

31. MSN Laboratories Pvt Ltd 29849, Approval Letter 44260

32. Novartis Healthcare Pvt Ltd 29884, Approval Letter 44240

33. Rubicon Research Pvt Ltd 29823, Approval Letter 44292

34. Rubicon Research Pvt Ltd 29822, Approval Letter 44294

35. Sanofi-Synthelabo India Ltd 29640, Approval Letter 43858

36. Shasun Pharmaceuticals Ltd 29836, Approval Letter 44276

37. Sun Pharmaceutical Industries 29814, Approval Letter Ltd 44297

38. Sun Pharmaceutical Industries 29813, Approval Letter Ltd 44298

39. Suven Life Sciences Limited 29962, Approval Letter 44333

42. Unichem Laboratories Ltd 29733, Approval Letter 43864

45. Watson Pharma Pvt Ltd 29918, Approval Letter 44230

46. Wockhardt Ltd 29920, Approval Letter 44391

49. Wockhardt Ltd 29934, Approval Letter 44322 50. Wockhardt Ltd 29935, Approval Letter 44321

51. Claris Lifesciences Ltd 30466, Amendment 45106 Letter

52. Glenmark Generics Ltd 30237, Amendment 44478 Letter

55. Glenmark Pharmaceuticals Ltd 30242, Amendment 44460 Letter

56. Hetero Labs Ltd 29215, Amendment 43279 Letter

57. Macleods Pharmaceuticals Ltd 31166, Amendment 45532 Letter

58. Mylan Laboratories Ltd 29673, Amendment 43725 Letter

59. Resonance Laboratories Pvt Ltd 30108, Amendment 44419 Letter

60. Rubicon Research Pvt Ltd 29824, Amendment 44290 Letter

61. Sun Pharma Advanced 31091, Amendment Research Company Ltd 45903 Letter

62. Sun Pharmaceutical Industries 29441, Amendment Ltd 43673, Letter 29440, 43678, 29439, 43676, 29810, 44301, 29809, 44302, 29808, 44303, 29811, 44300, 31090, 45360

NEW DRUG

S.NO. NAME OF APPLICANT DIARY TYPE OF LETTER NO. 1. M/s. Venus Remedies Ltd - CT NOC Letter

COSMETICS DIVISION

S.N COMPANY NAME DIARY NO STATUS O.

1. M/s. Magic Enterprises, Kerala 16785 Approval Letter

2. M/s. Cadila Healthcare Limited, Ahmedabad 23443 Approval Letter

3. M/s. ShoHan Chemical Pvt. Ltd, New Delhi 23551 Approval Letter

4. M/s. Baccarose Perfumes & Beauty Products Pvt. 19241 Approval Letter Ltd, Mumbai 5. M/s. Baccarose Perfumes & Beauty Products Pvt. 24058 Approval Letter Ltd, Mumbai

6. M/s. Avon Beauty Products India Pvt. Ltd, Gurgaon 23069 Approval Letter

7. M/s. Wockhardt Limited, Mumbai 15931 Deficiency Letter

8. M/s. Ranbaxy Laboratories Limited, Haryana 13755 Information

9. M/s. Sun Cosmeceutical Private Limited, Thane 22247 Approval Letter

1 M/s. Shiseido India Pvt. Ltd, Mumbai 20899, Approval Letter 0. 22287

1 M/s. Nivea India Pvt. Ltd, Mumbai 23040, Approval Letter 1. 22307, 21483, 21230, 21211, 21212, 22306