LETTERS FOR ISSUE ON 28.05.2014
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Lincoln Pharma / 52649 / - / Approval Letter
2. / M/s Zim Lab Ltd. / 0706 / 1703 / Approval Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. MSD / 980 / CT NOC Approval Letter
2. / M/s. Pfizer / 4661/20649/2120 / Additional Sites/TL Approval Letters
3. / M/s. Sanofi / 13750/15767 / Additional sites Approval Letter
4. / M/s. GSK / 51835 / PA Approval Letter
COSMETICS DIVISTION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Dofts and Blooms Beauty Solutions Pvt. Ltd, Chennai / 12974 / Approval Letter
2. / M/s. Khizar Marketing, Mumbai / 11861 / Approval Letter
3. / M/s. Berina Cosmetics Pvt. Ltd, New Delhi / 14144 / Approval Letter
4. / M/s. VLCC Healthcare Ltd, Haryana / 16318 / Approval Letter
5. / M/s. Oriflame India Private Limited, Jasola New Delhi / 13608 / Approval Letter
6. / M/s. Colorbar Cosmetics Private Limited, New Delhi / 14416, 14419 / Approval Letter
7. / M/s. VLCC Personal Care Ltd, New Delhi / 4782,14426,20918 / Approval Letter
8. / M/s. Talamela Retail LLP, New Delhi / 12166 / Approval Letter
9. / M/s. M.S. Distributors Pvt. Ltd, New Delhi / 11538 / Approval Letter
10. / M/s. Avon Beauty Products India Pvt. Ltd, Faridabad Expressway, Gurgaon / 11739 / Approval Letter
11. / M/s. Aakaar Medical Technologies Private Limited, New Delhi / 12500 / Approval Letter
12. / M/s. Rising Star Cosmetics Pvt. Ltd, New Delhi / FTS No. 10271 / Deficiency Letter
13. / M/s. J.K. International Delhi / FTS No. 9039 / Deficiency Letter
14. / M/s. Science & Soul, Chennai / FTS No. 15519 / Deficiency Letter
15. / M/s. Baccarose Perfumes & Beauty Products Pvt. Ltd, Mumbai / 9808 / Deficiency Letter
16. / M/s. Baccarose Perfumes & Beauty Products Pvt. Ltd, Mumbai / 10696 / Deficiency Letter
17. / M/s. Muk India, Baroda, Gujarat / 11790 / Deficiency Letter
18. / M/s. Headrush Marketing Pvt. Ltd, Mumbai / 10693 / Deficiency Letter
19. / M/s. Total Exports, Mumbai / 10841 / Deficiency Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Novartis Healthcare Pvt, Ltd / 939 / Acknowledge letter
2 / M/s Cliantha Research Ltd / 19989 / Approval Letter
3 / M/s Cadila Healthcare Pvt, ltd / 1661 / Approval Letter
4 / M/s Serum Institute of India Ltd / 15737 / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. KCI Medical India Pvt. Ltd. / 12766 / Approval (F-RC)
2. / M/s. Lepu Medical Technology (Beijing) Co. Ltd. / 11740 / Approval (F-RC)
3. / M/s. Lepu Medical Technology (Beijing) Co. Ltd. / 9966 / Approval (F-RC)
4. / M/s. Stryker India Pvt. Ltd. / 9949 / Approval (F-RC)
5. / M/s. S. P. Dental. / 11474 / Approval (R-RC)
6. / M/s. Kimberly-Clark Hygiene Products Pvt. Ltd. / 5537 / Approval (E-RC)
7. / M/s. Stryker India Pvt. Ltd. / 12159 / Approval (E-RC)
8. / M/s. St. Jude Medical India Pvt. Ltd. / 10010 / Approval (R-E-RC)
9. / M/s. Bard India Healthcare Pvt. Ltd. / 13774 / Approval (F-IL)
10. / M/s. KCI Medical India Pvt. Ltd. / 56660 / Approval (F-IL)
11. / M/s. Stryker India Pvt. Ltd. / 9949 / Approval (F-IL)
12. / M/s. India Medtronic Pvt. Ltd. / 18169 / Approval (R-IL)
13. / M/s. S. P. Dental. / 11474 / Approval (R-IL)
14. / M/s. India Medtronic Pvt. Ltd. / 57530 / Approval (E-IL)
15. / M/s. Bard India Healthcare Pvt. Ltd. / 13783 / Approval (R-E-IL)
16. / M/s. Stryker India Pvt. Ltd. / 45394 / Approval (R-E-IL)
17. / M/s. Stryker India Pvt. Ltd. / 14840 / Approval (R-E-IL)
18. / M/s. Bard India Healthcare Pvt. Ltd. / 13772 / Approval Letter
19. / M/s. Bard India Healthcare Pvt. Ltd. / 13782 / Approval Letter
20. / M/s. Bard India Healthcare Pvt. Ltd. / 13783 / Approval Letter
21. / M/s. MN Solution. / 15694 / Approval Letter
22. / M/s. Allergan Healthcare India Pvt. Ltd. / 9142 / Approval Letter
23. / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller(I), Ahmedabad (CLAA)
(M/s. Sigma Surgical Pvt. Ltd.) / FTS-7661 / Approval Letter
24. / The State Drugs Controller (I), Haryana (CLAA)
The Deputy Drugs Controller (I), Ghaziabad (CLAA)
M/s. Lars Medicare Pvt. Ltd., Haryana (CLAA) / FTS-26979 / Query Letter
25. / M/s. Best Hearing Solutions. / FTS-18920 / Query Letter
26. / M/s. Emergo (India) Consulting Pvt. Ltd. / 3906 / Query Letter
27. / M/s. India Medtronic Pvt. Ltd. / 12730 / Query Letter
28. / M/s. Stryker India Pvt. Ltd. / 8177 / Query Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Alere Medical Pvt. Ltd. / 12319 / Approval (IL)
2. / M/s. Immucor India Pvt. Ltd. / 16604 / Approval (IL)
3. / M/s. Immunoshop India Pvt. Ltd. / 9445 / Approval (IL)
4. / M/s. Alere Medical Pvt. Ltd. / 14918 / Approval (TL)
5. / M/s. Immunoshop India Pvt. Ltd. / 9445 / Query Letter
6. / M/s. KDH Biomedicals Pvt. Ltd. / 16953 / Query Letter
7. / M/s. Mobile Health Technologies India Pvt. Ltd. / 16577 / Query Letter
8. / M/s. Medsource Ozone Biomedical Pvt. Ltd. / 14232 / Query Letter
9. / M/s. POCT Services. / 15668 / Query Letter
10. / M/s. Meril Diagnostics Pvt. Ltd. / 14169 / Query Letter
11. / M/s. Sigma Aldrich Chemicals Pvt. Ltd. / 17453 / Query Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Indchemic Health Specialities Pvt. Ltd., / 11431 / Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Abhayam Pharmaceuticals / 17381, 26018 / Approval Letter
2. / Abhayam Pharmaceuticals / 17382, 26015 / Approval Letter
3. / Agila Specialties Pvt. Ltd / 17328, 25982 / Approval Letter
4. / Agila Specialties Pvt. Ltd / 17329, 25978 / Approval Letter
5. / Agila Specialties Pvt. Ltd / 17330, 25976 / Approval Letter
6. / Agila Specialties Pvt. Ltd. / 17327, 25984 / Approval Letter
7. / Ajanta Pharma Ltd / 17525, 26493 / Approval Letter
8. / Alembic Pharmaceuticals Ltd / 17546, 26500 / Approval Letter
9. / Alembic Pharmaceuticals Ltd / 17559, 26434 / Approval Letter
10. / Alembic Pharmaceuticals Ltd / 17560, 26419 / Approval Letter
11. / Alembic Pharmaceuticals Ltd / 17561, 26418 / Approval Letter
12. / Alembic Pharmaceuticals Ltd / 17562, 26414 / Approval Letter
13. / Alkem Laboratories Ltd / 17687, 26753 / Approval Letter
14. / Alphamed Formulations Pvt. Ltd / 17603, 26483 / Approval Letter
15. / Alphamed Formulations Pvt. Ltd / 17604, 26481 / Approval Letter
16. / Alphamed Formulations Pvt. Ltd / 17605, 26480 / Approval Letter
17. / Alphamed Formulations Pvt. Ltd / 17608, 26477 / Approval Letter
18. / Alphamed Formulations Pvt. Ltd / 17609, 26474 / Approval Letter
19. / Alphamed Formulations Pvt. Ltd / 17610, 26471 / Approval Letter
20. / Alphamed Formulations Pvt. Ltd / 17611, 26469 / Approval Letter
21. / Alphamed Formulations Pvt. Ltd / 17614, 26468 / Approval Letter
22. / Alphamed Formulations Pvt. Ltd / 17615, 26466 / Approval Letter
23. / Alphamed Formulations Pvt. Ltd / 17616, 26461 / Approval Letter
24. / Alphamed Formulations Pvt. Ltd / 17617, 26458 / Approval Letter
25. / Alphamed Formulations Pvt. Ltd / 17607, 26479 / Approval Letter
26. / Cadila Healthcare Limited / 17421, 25997 / Approval Letter
27. / Cadila Healthcare Limited / 17733, 26780 / Approval Letter
28. / Cipla Ltd / 17501, 26386 / Approval Letter
29. / Cipla Ltd / 17502, 26376 / Approval Letter
30. / Cipla Ltd / 17503, 26369 / Approval Letter
31. / Cipla Ltd / 17504, 26348 / Approval Letter
32. / Cipla Ltd / 17505, 26318 / Approval Letter
33. / Cipla Ltd / 17506, 26306 / Approval Letter
34. / Cipla Ltd / 17507, 26297 / Approval Letter
35. / Cipla Ltd / 17508, 26269 / Approval Letter
36. / Cipla Ltd / 17509, 26233 / Approval Letter
37. / Cipla Ltd / 17510, 26223 / Approval Letter
38. / Cipla Ltd / 17511, 26210 / Approval Letter
39. / Cipla Ltd / 17512, 26201 / Approval Letter
40. / Dr. Reddy’s Laboratories Ltd / 17649, 26460 / Approval Letter
41. / Dr. Reddy’s Laboratories Ltd / 17650, 26501 / Approval Letter
42. / Emcure Pharmaceuticals Ltd / 17704, 26763 / Approval Letter
43. / Emcure Pharmaceuticals Ltd / 17705, 26765 / Approval Letter
44. / Enem Nostrum Remedies Pvt Ltd / 17284, 25750 / Approval Letter
45. / FDC Ltd / 17263, 25780 / Approval Letter
46. / FDC Ltd / 17264, 25779 / Approval Letter
47. / Fresenius Kabi Oncology Ltd / 17488, 26498 / Approval Letter
48. / FTF Pharma Pvt. Ltd / 17628, 26437 / Approval Letter
49. / Gland Pharma Ltd. / 17659, 26492 / Approval Letter
50. / Glenmark Generics Ltd / 17653, 26486 / Approval Letter
51. / Glenmark Generics Ltd / 17654, 26487 / Approval Letter
52. / Glenmark Generics Ltd / 17655, 26482 / Approval Letter
53. / Glenmark Generics Ltd. / 17651, 26484 / Approval Letter
54. / Glenmark Pharmaceuticals Ltd / 17652, 26485 / Approval Letter
55. / Intas Pharmaceuticals Ltd / 17566, 26409 / Approval Letter
56. / Intas Pharmaceuticals Ltd / 17567, 26405 / Approval Letter
57. / Intas Pharmaceuticals Ltd / 17568, 26401 / Approval Letter
58. / Inventia Healthcare Pvt. Ltd / 17251, 25540 / Approval Letter
59. / Ipca Laboratories Limited / 17360, 26039 / Approval Letter
60. / Ipca Laboratories Limited / 17361, 26038 / Approval Letter
61. / Ipca Laboratories Limited / 17362, 26036 / Approval Letter
62. / Ipca Laboratories Limited / 17363, 26033 / Approval Letter
63. / Ipca Laboratories Limited / 17364, 26031 / Approval Letter
64. / Ipca Laboratories Limited / 17371, 26024 / Approval Letter
65. / Lupin Ltd / 17571, 26497 / Approval Letter
66. / Mylan Laboratories Ltd / 17279, 25727 / Approval Letter
67. / Mylan Laboratories Ltd / 17280, 25729 / Approval Letter
68. / Mylan Laboratories Ltd / 17281, 25755 / Approval Letter
69. / Mylan Laboratories Ltd / 17282, 25753 / Approval Letter
70. / Mylan Laboratories Ltd / 17283, 25752 / Approval Letter
71. / Mylan Laboratories Ltd / 17293, 25705 / Approval Letter
72. / Mylan Laboratories Ltd / 17294, 25704 / Approval Letter
73. / Mylan Laboratories Ltd / 17668, 26489 / Approval Letter
74. / Mylan Laboratories Ltd / 17669, 26488 / Approval Letter
75. / Onco Therapies Ltd / 17333, 25969 / Approval Letter
76. / Onco Therapies Ltd / 17334, 25967 / Approval Letter
77. / Onco Therapies Ltd / 17335, 25964 / Approval Letter
78. / Orbicular Pharmaceutical Technologies Pvt Ltd / 17662, 26467 / Approval Letter
79. / Orbicular Pharmaceutical Technologies Pvt Ltd / 17664, 26470 / Approval Letter
80. / Orchid Healthcare / 17624, 26441 / Approval Letter
81. / Ranbaxy Laboratories Ltd / 17633, 26456 / Approval Letter
82. / Sai Life Sciences Ltd / 17716, 26782 / Approval Letter
83. / Sai Life Sciences Ltd / 17717, 26781 / Approval Letter
84. / Sanofi-Synthelabo (India) Ltd / 17392, 25936 / Approval Letter
85. / Sanofi-Synthelabo (India) Ltd / 17393, 25933 / Approval Letter
86. / Sanofi-Synthelabo (India) Ltd / 17394, 25929 / Approval Letter
87. / Shasun Pharmaceuticals Ltd / 17306, 26008 / Approval Letter
88. / Sun Pharma Advanced Research Company Ltd / 17580, 26436 / Approval Letter
89. / Sun Pharmaceutical Industries Ltd / 14928, 22657 / Approval Letter
90. / Sun Pharmaceutical Industries Ltd / 17578, 26451 / Approval Letter
91. / Sun Pharmaceutical Industries Ltd / 17579, 26445 / Approval Letter
92. / Sun Pharmaceutical Industries Ltd / 17596, 26432 / Approval Letter
93. / Sun Pharmaceutical Industries Ltd / 17597, 26430 / Approval Letter
94. / Sun Pharmaceutical Industries Ltd / 17598, 26427 / Approval Letter
95. / Sun Pharmaceutical Industries Ltd / 17599, 26429 / Approval Letter
96. / Tevapharm India Pvt. Ltd / 17629, 26444 / Approval Letter
97. / Tevapharm India Pvt. Ltd / 17630, 26450 / Approval Letter
98. / Tevapharm India Pvt. Ltd / 17631, 26447 / Approval Letter
99. / Torrent Pharmaceuticals Ltd / 17407, 25924 / Approval Letter
100. / Torrent Pharmaceuticals Ltd / 17408, 25921 / Approval Letter
101. / Torrent Pharmaceuticals Ltd / 17409, 25917 / Approval Letter
102. / Torrent Pharmaceuticals Ltd / 17410, 25913 / Approval Letter
103. / Torrent Pharmaceuticals Ltd / 17411, 25911 / Approval Letter
104. / Torrent Pharmaceuticals Ltd / 17412, 25907 / Approval Letter
105. / Torrent Pharmaceuticals Ltd / 17413, 25904 / Approval Letter
106. / Torrent Pharmaceuticals Ltd / 17414, 25944 / Approval Letter
107. / Unique Pharmaceutical Laboratories / 17484, 26499 / Approval Letter
108. / Vimta Labs Ltd / 17285, 25747 / Approval Letter
109. / Vimta Labs Ltd / 17545, 26495 / Approval Letter
110. / Vimta Labs Ltd / 17347, 26020 / Approval Letter
111. / Vimta Labs Ltd / 17348, 25951 / Approval Letter
112. / Vimta Labs Ltd / 17349, 25954 / Approval Letter
113. / Vimta Labs Ltd / 17350, 25958 / Approval Letter
114. / Wintac Limited / 17313, 26170 / Approval Letter
115. / Wintac Limited / 17314, 26168 / Approval Letter
116. / Wintac Limited / 17315, 26177 / Approval Letter
117. / Wintac Limited / 17316, 26176 / Approval Letter
118. / Wintac Limited / 17317, 26175 / Approval Letter
119. / Wintac Limited / 17318, 26174 / Approval Letter
120. / Wintac Limited / 17319, 26044 / Approval Letter
121. / Zoetis Pharmaceutical Research Pvt Ltd / 17258, 25537 / Approval Letter