LETTERS FOR ISSUE ON 16.10.2014
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Johnson & Johnson Ltd. / 18685 / Approval (F-RC)
2. / M/s. Zaife-Med India Surgicals Pvt. Ltd. / 31667 / Approval (F-RC)
3. / M/s. Zaife-Med India Surgicals Pvt. Ltd. / 31667 / Approval (F-IL)
4. / M/s. Smith & Nephew Healthcare Pvt. Ltd. / 31159 / Approval (R-RC)
5. / M/s. Smith & Nephew Healthcare Pvt. Ltd. / 31159 / Approval (R-IL)
6. / M/s. Biomet Orthopaedic India Pvt. Ltd. / 33807 / Approval (E-RC)
7. / M/s. Biomet Orthopaedic India Pvt. Ltd. / 33807 / Approval (E-IL)
8. / M/s. B. Braun Medical (India) Pvt. Ltd. / 18591 / Approval (R-E-RC)
9. / M/s. B. Braun Medical (India) Pvt. Ltd. / 18591 / Approval (R-E-IL)
10. / M/s. Johnson & Johnson Ltd. / 32246 / Approval (R-E-RC)
11. / M/s. Johnson & Johnson Ltd. / 32246 / Approval (R-E-IL)
12. / M/s. Biogenomics Limited. / 33831 / Approval (F-IL)
13. / M/s. Cardio Products Corporation. / 35013 / Approval (F-IL)
14. / M/s. Depuy Medical Pvt. Ltd. / 18685 / Approval (F-IL)
15. / M/s. 3G Medical System. / 35726 / Approval (F-IL)
16. / M/s. Johnson & Johnson Ltd. / 32775 / Letter
17. / M/s. BioradMedisys Pvt. Ltd. / 36139 / Letter
18. / M/s. Meril Life Sciences India Pvt. Ltd. / 41445 / Letter
19. / M/s. Meril Life Sciences India Pvt. Ltd. / 38288 / Letter
20. / M/s. Meril Life Sciences India Pvt. Ltd. / 27591 / Letter
21. / M/s. India Medtronic Pvt. Ltd. / 29178 / Letter
22. / M/s. Zaife-Med India Surgicals Pvt. Ltd. / 31667 / Query Letter
23. / M/s. Fortis Escorts Heart Institute & Research Centre / 34133 / Letter
24. / M/s. Edwards Lifesciences (India) Pvt. Ltd. / 43026 / Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / Becton Dickinson India Pvt. Ltd.,
All port offices of CDSCO. / 35665 / Approval (IL)
2. / M/s. OSB Agencies Pvt. Ltd. / 34988 / Query Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. I Process / 5435 / TL Approval
2. / M/s. GSK / 52675/33644 / Clarification Letter
3. / M/s. A. Menarini / 31565/54415 / TL Approval/Change in CRO Approval
4. / M/s. Excel Life Sciences / 30802 / Change in PI Approval
VACCINE DIVISION
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Shantha Biotechnices Ltd / 37595 / Approval Letter
2 / M/s Johnson & Johnson Ltd / 9691, 9690 / Clarification Letter
3 / M/s Biocon Ltd / 21764 / Approval Letter
4 / M/s GSK Pharmaceuticals Ltd / 28521 / Acknowledge Letter
5 / M/s Serum Institute of India ltd / 35317 / Approval Letter
6 / M/s Roche Product India Pvt, ltd / 31462 / Clarification Letter
8 / M/s Prosper Channel Lifesciences India Pvt, ltd / Approval Letter
9 / M/s Biological E. Ltd / 33754, 53400,53405 (fts no) / Acknowledge Letter & Approval Letter
10 / M/s Ventakeshwara Hatcheries Pvt, ltd / 49790 (fts no) / Approval Letter
EXPORT OF BIOLOGICAL SAMPLES
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s Lamda Therapeutics Research Ltd / 39915 / Approval Letter
2 / M/s Synchron Research Services Pvt, ltd / 40572, 40377, 36182, / Approval Letter
3 / M/s Cliantha Research Ltd / 41442, 40104 / Approval Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Accutest Research Lab (I) Pvt. Ltd. / 40124, 59130 / Approval Letter
2. / Agila Specialties Pvt Ltd / 40334, 59255 / Approval Letter
3. / Agila Specialties Pvt Ltd / 40332, 59188 / Approval Letter
4. / Agila Specialties Pvt Ltd / 40333, 591848 / Approval Letter
5. / Ajanta Pharma Ltd / 40121, 59198 / Approval Letter
6. / Ajanta Pharma Ltd / 40120, 59194 / Approval Letter
7. / Ajanta Pharma Ltd / 40122, 59189 / Approval Letter
8. / Ajanta Pharma Ltd / 40123, 59185 / Approval Letter
9. / Akorn India Pvt Ltd. / 40348, 59201 / Approval Letter
10. / APL Research Centre / 40390, 59153 / Approval Letter
11. / APL Research Centre / 40396, 59156 / Approval Letter
12. / APL Research Centre / 40392, 59159 / Approval Letter
13. / APL Research Centre / 40393, 59158 / Approval Letter
14. / APL Research Centre / 40388, 59151 / Approval Letter
15. / APL Research Centre / 40386, 59289 / Approval Letter
16. / APL Research Centre / 40385, 59291 / Approval Letter
17. / APL Research Centre / 40384, 59293 / Approval Letter
18. / APL Research Centre / 40389, 59171 / Approval Letter
19. / APL Research Centre / 40395, 59163 / Approval Letter
20. / APL Research Centre / 40394, 59162 / Approval Letter
21. / APL Research Centre / 40391, 59160 / Approval Letter
22. / APL Research Centre / 40387, 59287 / Approval Letter
23. / Biocon Limited-SEZ Unit / 40137, 59126 / Approval Letter
24. / Biocon Limited-SEZ Unit / 40145, 59278 / Approval Letter
25. / Biocon Limited-SEZ Unit / 40146, 59288 / Approval Letter
26. / Biocon Limited-SEZ Unit / 40147, 59285 / Approval Letter
27. / Biogen Idec Biotech India Pvt. Ltd / 40161, 59141 / Approval Letter
28. / Cadila Healthcare Limited / 40398, 59217 / Approval Letter
29. / Cadila Healthcare Limited / 40397, 59223 / Approval Letter
30. / Cadila Healthcare Limited / 40336, 59246 / Approval Letter
31. / Cadila Healthcare Limited / 40547, 59751 / Approval Letter
32. / Cadila Healthcare Limited / 40577,59749 / Approval Letter
33. / Cadila Healthcare Ltd / 40335, 59251 / Approval Letter
34. / Cadila Healthcare Ltd / 40337, 59239 / Approval Letter
35. / Cadila Healthcare Ltd / 40338, 59231 / Approval Letter
36. / Cadila Healthcare Ltd / 40339, 59225 / Approval Letter
37. / Centaur Pharmaceuticals Pvt. Ltd / 40159, 59108 / Approval Letter
38. / Centaur Pharmaceuticals Pvt. Ltd / 40160, 59110 / Approval Letter
39. / Cipla Ltd / 40201, 59353 / Approval Letter
40. / Cipla Ltd / 40202, 59350 / Approval Letter
41. / Cipla Ltd / 40203, 59349 / Approval Letter
42. / Cipla Ltd / 40204, 59345 / Approval Letter
43. / Cipla Ltd / 40205, 59341 / Approval Letter
44. / Cipla Ltd / 40206, 59338 / Approval Letter
45. / Cipla Ltd / 40207, 59336 / Approval Letter
46. / Cipla Ltd / 40208, 59333 / Approval Letter
47. / Cipla Ltd / 40209, 59328 / Approval Letter
48. / Cipla Ltd / 40210, 59326 / Approval Letter
49. / Cipla Ltd / 40211, 59322 / Approval Letter
50. / Cipla Ltd / 40212, 59317 / Approval Letter
51. / Cipla Ltd / 40213, 59374 / Approval Letter
52. / Cipla Ltd / 40221, 59371 / Approval Letter
53. / Cipla Ltd / 40222, 59370 / Approval Letter
54. / Cipla Ltd / 40223, 59368 / Approval Letter
55. / Cipla Ltd / 40224, 59366 / Approval Letter
56. / Cipla Ltd / 40225, 59363 / Approval Letter
57. / Cipla Ltd / 40226, 59362 / Approval Letter
58. / Cipla Ltd / 40227, 59360 / Approval Letter
59. / Cipla Ltd / 40228, 59357 / Approval Letter
60. / Cipla Ltd / 40229, 59355 / Approval Letter
61. / Cipla Ltd / 39466, 58369 / Approval Letter
62. / Cipla Ltd / 37987, 56490 / Approval Letter
63. / Cipla Ltd / 39536, 58351 / Approval Letter
64. / Cipla Ltd / 40506, 59663 / Approval Letter
65. / Cipla Ltd / 40507, 59661 / Approval Letter
66. / Cipla Ltd / 40508, 59659 / Approval Letter
67. / Cipla Ltd / 40509, 59657 / Approval Letter
68. / Cipla Ltd / 40510, 59674 / Approval Letter
69. / Cipla Ltd / 40511, 59671 / Approval Letter
70. / Cipla Ltd / 40512, 59666 / Approval Letter
71. / Cipla Ltd / 40513, 59677 / Approval Letter
72. / Cipla Ltd / 40514, 59680 / Approval Letter
73. / Cipla Ltd / 40515, 59685 / Approval Letter
74. / Emcure Pharmaceuticals Ltd / 40125, 59149 / Approval Letter
75. / Emcure Pharmaceuticals Ltd / 40126, 59114 / Approval Letter
76. / Encube Ethicals Pvt. Ltd / 40428, 59123 / Approval Letter
77. / Famy Care Ltd / 40481, 59642 / Approval Letter
78. / Gland Pharma Ltd / 40387, 59287 / Approval Letter
79. / Glenmark Generics Ltd / 40406, 59303 / Approval Letter
80. / Glenmark Generics Ltd / 40407, 59305 / Approval Letter
81. / Glenmark Generics Ltd / 40408, 59297 / Approval Letter
82. / Glenmark Generics Ltd / 40409, 59299 / Approval Letter
83. / Hetero Labs Ltd / 40497, 59732 / Approval Letter
84. / Hetero Labs Ltd / 40498, 59730 / Approval Letter
85. / Hetero Labs Ltd / 40500, 59734 / Approval Letter
86. / Inventia Healthcare Pvt Ltd / 40277, 59195 / Approval Letter
87. / Inventia Healthcare Pvt Ltd / 40275, 59117 / Approval Letter
88. / Inventia Healthcare Pvt Ltd / 40276, 59500 / Approval Letter
89. / Lupin Ltd / 40340, 59207 / Approval Letter
90. / Lupin Ltd / 40527, 59757 / Approval Letter
91. / Lupin Ltd / 40528, 59755 / Approval Letter
92. / Lupin Ltd / 40529, 59753 / Approval Letter
93. / Macleods Pharmaceuticals Ltd / 40140, 59154 / Approval Letter
94. / Macleods Pharmaceuticals Ltd / 40138, 59146 / Approval Letter
95. / Macleods Pharmaceuticals Ltd / 40427, 59483 / Approval Letter
96. / Macleods Pharmaceuticals Ltd / 40139, 59150 / Approval Letter
97. / Mylan Laboratories Ltd / 40251, 59489 / Approval Letter
98. / Mylan Laboratories Ltd / 40250, 59487 / Approval Letter
99. / Mylan Laboratories Ltd / 40249, 59485 / Approval Letter
100. / Mylan Laboratories Ltd / 40246, 59269 / Approval Letter
101. / Mylan Laboratories Ltd / 40244, 59256 / Approval Letter
102. / Mylan Laboratories Ltd / 40245, 59261 / Approval Letter
103. / Mylan Laboratories Ltd / 40247, 59264 / Approval Letter
104. / Mylan Pharmaceuticals Pvt. Ltd / 40248, 59508 / Approval Letter
105. / Onco Therapies Ltd / 40331, 59192 / Approval Letter
106. / Orbicular Pharmaceutical Technologies Pvt Ltd / 40597, 59700 / Approval Letter
107. / Orbicular Pharmaceutical Technologies Pvt Ltd / 40598, 59696 / Approval Letter
108. / Orbicular Pharmaceutical Technologies Pvt Ltd / 40599, 59692 / Approval Letter
109. / Orchid Healthcare / 40349, 59234 / Approval Letter
110. / Orchid Healthcare / 40350, 59229 / Approval Letter
111. / Sanofi-Synthelabo (India) Ltd / 40418, 59315 / Approval Letter
112. / Sanofi-Synthelabo (India) Ltd / 40419, 59318 / Approval Letter
113. / Sanofi-Synthelabo (India) Ltd / 40420, 59321 / Approval Letter
114. / Sanofi-Synthelabo (India) Ltd / 40421, 59324 / Approval Letter
115. / Sanofi-Synthelabo (India) Ltd / 40422, 63020 / Approval Letter
116. / Sanofi-Synthelabo (India) Ltd / 40417, 59311 / Approval Letter
117. / Sanofi-Synthelabo (India) Ltd / 40416, 59309 / Approval Letter
118. / Sitec Labs Pvt Ltd / 40432, 59133 / Approval Letter
119. / Sun Pharma Advanced Research Company Ltd / 40361, 59147 / Approval Letter
120. / Sun Pharma Advanced Research Company Ltd / 40357, 59478 / Approval Letter
121. / Sun Pharma Laboratories Ltd / 40364, 59238 / Approval Letter
122. / Sun Pharma Laboratories Ltd / 40359, 59245 / Approval Letter
123. / Sun Pharma Laboratories Ltd / 40355, 59496 / Approval Letter
124. / Sun Pharmaceutical Industries Ltd / 40363, 59250 / Approval Letter
125. / Sun Pharmaceutical Industries Ltd / 40358, 59143 / Approval Letter
126. / Sun Pharmaceutical Industries Ltd / 40362, 59145 / Approval Letter
127. / Sun Pharmaceutical Industries Ltd / 40360, 59139 / Approval Letter
128. / Sun Pharmaceutical Industries Ltd / 40354, 59497 / Approval Letter
129. / Sun Pharmaceutical Industries Ltd / 40353, 59499 / Approval Letter
130. / Sun Pharmaceutical Industries Ltd / 40356, 59481 / Approval Letter
131. / Sun Pharmaceutical Industries Ltd / 40530, 59711 / Approval Letter
132. / Sun Pharmaceutical Industries Ltd / 40531, 59717 / Approval Letter
133. / Sun Pharmaceutical Industries Ltd / 40532, 59707 / Approval Letter
134. / Sun Pharmaceutical Industries Ltd / 40533, 59704 / Approval Letter
135. / Sun Pharmaceutical Industries Ltd / 40534, 59714 / Approval Letter
136. / Syngene International Limited / 40158, 59296 / Approval Letter
137. / Syngene International Limited / 40157, 59302 / Approval Letter
138. / Syngene International Limited / 40156, 59306 / Approval Letter
139. / Syngene International Limited / 40144, 59312 / Approval Letter
140. / Tevapharm India Pvt. Ltd / 40399, 59258 / Approval Letter
141. / Tevapharm India Pvt. Ltd / 40405, 59260 / Approval Letter
142. / Tevapharm India Pvt. Ltd / 40403, 59263 / Approval Letter
143. / Tevapharm India Pvt. Ltd / 40402, 59265 / Approval Letter
144. / Tevapharm India Pvt. Ltd / 40401, 59267 / Approval Letter
145. / Tevapharm India Pvt. Ltd / 40400, 59271 / Approval Letter
146. / Tevapharm India Pvt. Ltd / 40404, 59276 / Approval Letter
147. / Torrent Pharmaceuticals Ltd / 40268, 59212 / Approval Letter
148. / Torrent Pharmaceuticals Ltd / 40273, 59208 / Approval Letter
149. / Torrent Pharmaceuticals Ltd / 40274, 59206 / Approval Letter
150. / Torrent Pharmaceuticals Ltd / 40272, 59504 / Approval Letter
151. / Torrent Pharmaceuticals Ltd / 40271, 59506 / Approval Letter
152. / Torrent Pharmaceuticals Ltd / 40270, 54490 / Approval Letter
153. / Torrent Pharmaceuticals Ltd / 40269, 59492 / Approval Letter
154. / USV Limited / 40475, 59740 / Approval Letter
155. / USV Limited / 40477, 59735 / Approval Letter
156. / USV Limited / 40478, 59744 / Approval Letter
157. / USV Limited / 40479, 59746 / Approval Letter
158. / USV Limited / 40480, 59747 / Approval Letter
159. / USV Limited / 40476, 59737 / Approval Letter
160. / V-ensure Pharma Technologies Pvt Ltd / 40465, 59654 / Approval Letter
161. / V-ensure Pharma Technologies Pvt Ltd / 40466, 59645 / Approval Letter
162. / V-ensure Pharma Technologies Pvt Ltd / 40467, 59651 / Approval Letter
163. / V-ensure Pharma Technologies Pvt Ltd / 40468, 59648 / Approval Letter
164. / Wockhardt Ltd / 40162, 59282 / Approval Letter
COSMETICS DIVISION