LETTERS FOR ISSUE ON 24.04.2014
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Bristol-Myers Squibb / 34399 / 48539 / Approval Letter
2. / M/s Inventia Healthcare / 63897, 9704 / 87788 / Approval Letter,
Amendment Letter
3. / M/s Manipal Acunova / 59083 / 81633 / Approval Letter
4. / M/s Torrent Pharma / 8906 / - / Amendment Letter
5. / M/s Troikaa Pharma / 5130 / - / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. B. Braun Medical (India) Pvt. Ltd. / 63537 / Query Letter
2. / M/s. Boston Scientific India Pvt. Ltd. / 8418 / Query Letter
3. / M/s. Becton Dickinson India Pvt. Ltd. / 6608 / Query Letter
4. / M/s. Feron Life Sciences (P) Ltd. / 9088 / Query Letter
5. / M/s. Synthes Medial Pvt. Ltd. / 6641 / Query Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Actavis Pharma Development Centre Pvt Ltd / 11539, 17718 / Approval Letter
2. / Actavis Pharma Development Centre Pvt Ltd / 11540, 17715 / Approval Letter
3. / Agila Specialties Pvt Ltd / 11643, 17753 / Approval Letter
4. / Agila Specialties Pvt Ltd / 11645, 17767 / Approval Letter
5. / Agila Specialties Pvt Ltd / 11644, 17761 / Approval Letter
6. / Agila Specialties Pvt Ltd / 11654, 17748 / Approval Letter
7. / Agila Specialties Pvt Ltd / 11637, 17908 / Approval Letter
8. / Agila Specialties Pvt Ltd / 63463, 87206, 12077, 18428 / Approval Letter
9. / Aizant Drug Research Solutions Pvt Ltd / 11741, 18168 / Approval Letter
10. / Ajanta Pharma Ltd / 11470, 17942 / Approval Letter
11. / Ajanta Pharma Ltd / 11471, 17935 / Approval Letter
12. / Ajanta Pharma Ltd / 11472, 17930 / Approval Letter
13. / Ajanta Pharma Ltd / 11453, 17928 / Approval Letter
14. / Ajanta Pharma Ltd / 11469, 17864 / Approval Letter
15. / APL Research Centre / 11729, 18183 / Approval Letter
16. / APL Research Cetre / 11730, 18179 / Approval Letter
17. / Biotech Ophthalmics Pvt. Ltd / 11543, 17710 / Approval Letter
18. / Cadila Healthcare Limited / 11634, 17912 / Approval Letter
19. / Cadila Healthcare Limited / 11635, 17911 / Approval Letter
20. / Cadila Pharmaceuticals Ltd / 11728, 18185 / Approval Letter
21. / Claris Lifesciences Ltd / 11727, 18188 / Approval Letter
22. / Claris Lifesciences Ltd / 11744, 18171 / Approval Letter
23. / Claris Lifesciences Ltd / 11733, 18173 / Approval Letter
24. / Claris Lifesciences Ltd / 11745, 18172 / Approval Letter
25. / Claris Lifesciences Ltd / 11746, 18174 / Approval Letter
26. / Claris Lifesciences Ltd / 11743, 18175 / Approval Letter
27. / Claris Lifesciences Ltd / 11742, 18176 / Approval Letter
28. / Emcure Pharmaceuticals Ltd / 11515, 17726 / Approval Letter
29. / Emcure Pharmaceuticals Ltd / 11509, 17733 / Approval Letter
30. / Emcure Pharmaceuticals Ltd / 11508, 17740 / Approval Letter
31. / Eugia Pharma Specialties Ltd / 11510, 17731 / Approval Letter
32. / Getz Pharma Research Pvt Ltd / 11548, 17700 / Approval Letter
33. / Getz Pharma Research Pvt Ltd / 11562, 17697 / Approval Letter
34. / Hetero Labs Ltd / 11917, 18074 / Approval Letter
35. / Hospira Healthcare India Pvt. Ltd / 11640, 17895 / Approval Letter
36. / Hospira Healthcare India Pvt. Ltd / 11639, 17960 / Approval Letter
37. / Hospira Healthcare India Pvt. Ltd / 11641, 17889 / Approval Letter
38. / Hospira Healthcare India Pvt. Ltd / 11642, 17881 / Approval Letter
39. / Indoco Remedies Ltd / 11531, 17720 / Approval Letter
40. / Indoco Remedies Ltd / 11530, 17722 / Approval Letter
41. / Ipca Laboratories Limited / 11665, 17874 / Approval Letter
42. / Ipca Laboratories Limited / 11664, 17850 / Approval Letter
43. / Johnson and Johnson Ltd / 11656, 17781 / Approval Letter
44. / Johnson and Johnson Ltd / 11657, 17787 / Approval Letter
45. / Macleods Pharmaceuticals Ltd / 11572, 17689 / Approval Letter
46. / Orchid Healthcare / 11638, 17907 / Approval Letter
47. / Piramal Enterprises Ltd / 11339, 17426 / Approval Letter
48. / RA Chem Pharma Ltd / 11663, 17852 / Approval Letter
49. / RA Chem Pharma Ltd / 11667, 17854 / Approval Letter
50. / RA Chem Pharma Ltd / 11666, 17857 / Approval Letter
51. / Ranbaxy Laboratories Ltd / 10650, 16352 / Approval Letter
52. / Shasun Pharmaceuticals Ltd / 11426, 17917 / Approval Letter
53. / Shasun Pharmaceuticals Ltd / 11429, 17916 / Approval Letter
54. / Shasun Pharmaceuticals Ltd / 11430, 17915 / Approval Letter
55. / Shasun Pharmaceuticals Ltd / 11436, 17914 / Approval Letter
56. / Shasun Pharmaceuticals Ltd / 11437, 17913 / Approval Letter
57. / Shasun Pharmaceuticals Ltd / 11425, 17845 / Approval Letter
58. / Shasun Pharmaceuticals Ltd / 3448, 5913, 15211, 22971 / Approval Letter
59. / Sidmak Laboratories (India) Pvt Ltd / 11818, 18068 / Approval Letter
60. / Strides Arcolab Ltd / 11652, 17775 / Approval Letter
61. / Strides Arcolab Ltd / 11653, 17774 / Approval Letter
62. / Sun Pharmaceutical Industries Ltd / 11659, 17919 / Approval Letter
63. / Sun Pharmaceutical Industries Ltd / 11658, 17922 / Approval Letter
64. / Torrent Pharmaceuticals Ltd / 11480, 17948 / Approval Letter
65. / Torrent Pharmaceuticals Ltd / 11479, 17924 / Approval Letter
66. / Umedica Laboratories Pvt Ltd / 11706, 17844 / Approval Letter
67. / Unimark Remedies Ltd / 11716, 18214 / Approval Letter
68. / Unique Pharmaceutical Laboratories / 11767, 18154 / Approval Letter
69. / Unique Pharmaceutical Laboratories / 11758, 18156 / Approval Letter
70. / Unique Pharmaceutical Laboratories / 11757, 18157 / Approval Letter
71. / Unique Pharmaceutical Laboratories / 11747, 18159 / Approval Letter
72. / Unique Pharmaceutical Laboratories / 11748, 18161 / Approval Letter
73. / Unique Pharmaceutical Laboratories / 11749, 18162 / Approval Letter
74. / Vimta Labs Ltd / 11629, 17950 / Approval Letter
75. / Wockhardt Ltd / 11563, 17693 / Approval Letter
76. / Wockhardt Ltd / 11574, 17945 / Approval Letter
77. / Zoetis Pharmaceutical Research Pvt Ltd / 1906, 3358, 8560, 13011, 16065, 23839 / Approval Letter
78. / Zoetis Pharmaceutical Research Pvt Ltd / 1909, 3216, 8560, 13011, 16065, 23839 / Approval Letter
79. / Zoetis Pharmaceutical Research Pvt Ltd / 1898, 3318, 8560, 13011, 16065, 23839 / Approval Letter
80. / Zoetis Pharmaceutical Research Pvt Ltd / 1899, 3316, 8560, 13011, 16065, 23839 / Approval Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Sun Pharmaceuticals / - / Letter
2. / M/s. Sparsha Pharma International / - / Clarification Letter (2)
3. / M/s. Glenmark Pharmaceuticals / - / Clarification Letter
4. / M/s. MSN Laboratories / - / Clarification Letter
5. / M/s. Centaur Pharmaceuticals / - / Approval Letter
6. / M/s. Brisal-Meyers Squibb / - / Clarification Letter
7. / M/s. Metrochem / - / Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s GlaxoSmithKline Pharmaceuticals Ltd / 8760, 2099 / Clarification & approval letter
2 / M/s Roche Products (India) Pvt Ltd / 6786, 5776, 6787 / Clarification & approval letter
3 / M/s Kasiak Research Pvt Ltd / 28015 / Approval letter
4 / M/s Bharat Biotec International Ltd / 1798 / Approval letter
5 / M/s Sanofi Pasteur India Pvt Ltd / 9119 / Approval & Clarification letter
6 / M/s Bharat Immunologicals & Biologicals Corp. Ltd / 5765 / Clarification letter
7 / M/s Biomed Pvt Ltd / 5761 / Approval letter
8 / M/s Lupin Ltd / 5629 / Approval letter
9 / M/s Ceva (I) Pvt Ltd / Clarification letter
10 / M/s Sandor Medicaids Pvt Ltd / 19778,44815, 10705 / Approval letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 10333 / Approval Letter
2. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 7397 / Approval Letter
3. / M/s. Indoco Remedies Ltd., Navi Mumbai-400 701 / 7130 / Clarification Letter
4. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 6635 / Approval Letter
5. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 30800 / Approval Letter
6. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Coimbatore-641029 / 10248 / Approval Letter
7. / M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 11909 / Clarification Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Cipla Limited, Mumbai-400 008 / 12960 / Test Licence
2. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 7642 / Test Licence
3. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 7128 / Test Licence
4. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600059 / 11408 / Test Licence