LETTERS FOR ISSUE ON 31.03.2014
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / AET Laboratories Pvt. Ltd / 6220, 9800 / Approval Letter
2. / AET Laboratories Pvt. Ltd / 6221, 9801 / Approval Letter
3. / Agila Specialties Pvt Ltd / 60510, 83469, 7810, 11625 / Approval Letter
4. / Agila Specialties Pvt Ltd / 4915, 7507 / Approval Letter
5. / Agila Specialties Pvt Ltd / 6361, 10434 / Approval Letter
6. / Aizant Drug Research Sollutions Pvt Ltd / 6575, 10404 / Approval Letter
7. / Aizant Drug Research Solutions Pvt Ltd / 64686, 88796, 5540, 8947 / Approval Letter
8. / Akums Drugs & Pharmaceuticals Ltd / 7040, 10955 / Approval Letter
9. / Alembic Pharmaceuticals Ltd / 6588, 10430 / Approval Letter
10. / Alembic Pharmaceuticals Ltd / 6581, 10408 / Approval Letter
11. / Alembic Pharmaceuticals Ltd / 6582, 10411 / Approval Letter
12. / Alembic Pharmaceuticals Ltd / 6585, 10418 / Approval Letter
13. / Alembic Pharmaceuticals Ltd / 6584, 10416 / Approval Letter
14. / Alembic Pharmaceuticals Ltd / 6583, 10413 / Approval Letter
15. / Alembic Pharmaceuticals Ltd / 6586, 10421 / Approval Letter
16. / Alembic Pharmaceuticals Ltd / 6587, 10425 / Approval Letter
17. / Alkem Laboratories Ltd / 6121, 9716 / Approval Letter
18. / Alkem Laboratories Ltd / 7035, 11011 / Approval Letter
19. / Alkem Laboratories Ltd / 5314,
8361 / Approval Letter
20. / APL Research Centre / 6566, 10219 / Approval Letter
21. / Apotex Research Pvt Ltd / 6957, 10999 / Approval Letter
22. / Apotex Research Pvt Ltd / 6958, 11001 / Approval Letter
23. / Apotex Research Pvt Ltd / 6956, 10987 / Approval Letter
24. / Apotex Research Pvt Ltd / 6955, 10989 / Approval Letter
25. / Apotex Research Pvt Ltd / 6954, 10991 / Approval Letter
26. / Appcure Labs / 7078, 10842 / Approval Letter
27. / Appcure Labs / 7079, 10945 / Approval Letter
28. / Astral SteriTech Pvt Ltd / 2691, 4512, 6319, 9821 / Approval Letter
29. / Biocon Ltd / 2637, 6110, 7594, 11851 / Approval Letter
30. / Biocon Ltd / 2638, 6112, 7594, 11851 / Approval Letter
31. / Cadila Healthcare Ltd / 6752, 10360 / Approval Letter
32. / Cadila Healthcare Ltd / 6753, 10361 / Approval Letter
33. / Cadila Healthcare Ltd / 6754, 10362 / Approval Letter
34. / Cadila Healthcare Ltd / 6755, 10364 / Approval Letter
35. / Cadila Healthcare Ltd / 6757, 10368 / Approval Letter
36. / Cadila Healthcare Ltd / 6756, 10365 / Approval Letter
37. / Cadila Pharmaceuticals Ltd / 6561, 10228 / Approval Letter
38. / Cipla Ltd / 6250, 9810 / Approval Letter
39. / Cipla Ltd / 6249, 9808 / Approval Letter
40. / Cipla Ltd / 7118, 10799 / Approval Letter
41. / Cipla Ltd / 7117, 10803 / Approval Letter
42. / Cipla Ltd / 7123, 10809 / Approval Letter
43. / Cipla Ltd / 7125, 10926 / Approval Letter
44. / Cipla Ltd / 7122, 10811 / Approval Letter
45. / Cipla Ltd / 7121, 10817 / Approval Letter
46. / Cipla Ltd / 7126, 10986 / Approval Letter
47. / Claris Lifesciences Ltd / 6129, 9752 / Approval Letter
48. / Claris Lifesciences Ltd / 6130,9749 / Approval Letter
49. / Claris Lifesciences Ltd / 6124, 9741 / Approval Letter
50. / Claris Lifesciences Ltd / 6125, 9738 / Approval Letter
51. / Claris Lifesciences Ltd / 6126, 9734 / Approval Letter
52. / Concord Biotech Ltd / 6282, 9814 / Approval Letter
53. / Dr. Reddy’s Laboratories Ltd / 6139, 9746 / Approval Letter
54. / Dr. Reddy’s Laboratories Ltd / 6140, 9744 / Approval Letter
55. / Dr. Reddy’s Laboratories Ltd / 39592, 54371, 7913, 12042 / Approval Letter
56. / Emcure Pharmaceuticals Ltd / 2700, 4507, 6028, 9446 / Approval Letter
57. / FDC Ltd / 3336, 5539, 10637, 16362 / Approval Letter
58. / Getz Pharma Research Pvt Ltd / 6558, 11054 / Approval Letter
59. / Getz Pharma Research Pvt Ltd / 6556, 11064 / Approval Letter
60. / Getz Pharma Research Pvt Ltd / 6557, 11059 / Approval Letter
61. / Getz Pharma Research Pvt Ltd / 6555, 11067 / Approval Letter
62. / Getz Pharma Research Pvt Ltd / 6554, 11071 / Approval Letter
63. / Glenmark Pharmaceuticals Ltd / 354, 941, 7304, 11123 / Approval Letter
64. / Glenmark Pharmaceuticals Ltd / 6633, 10398 / Approval Letter
65. / Glenmark Pharmaceuticals Ltd / 6626, 10395 / Approval Letter
66. / Glenmark Pharmaceuticals Ltd / 6630, 10391 / Approval Letter
67. / Glenmark Pharmaceuticals Ltd / 6631, 10388 / Approval Letter
68. / Glenmark Pharmaceuticals Ltd / 6632, 10385 / Approval Letter
69. / HLL Life care Ltd / 3711, 5833, 8477, 12840 / Approval Letter
70. / Hospira Healthcare India Pvt Ltd / 60968, 83800, 5179, 8064 / Approval Letter
71. / Indoco Remedies Ltd / 7061, 10846 / Approval Letter
72. / Indoco Remedies Ltd / 7060, 10847 / Approval Letter
73. / Indoco Remedies Ltd / 7059, 10919 / Approval Letter
74. / Indoco Remedies Ltd / 7058, 10922 / Approval Letter
75. / Indoco Remedies Ltd / 7057, 10923 / Approval Letter
76. / Indoco Remedies Ltd / 7049, 10733 / Approval Letter
77. / Indoco Remedies Ltd / 7048, 10737 / Approval Letter
78. / Indoco Remedies Ltd / 7047, 10758 / Approval Letter
79. / Indoco Remedies Ltd / 7046, 10763 / Approval Letter
80. / Indoco Remedies Ltd / 7045, 10768 / Approval Letter
81. / Indoco Remedies Ltd / 7044, 10770 / Approval Letter
82. / Indoco Remedies Ltd / 2383, 3998, 8106, 12422 / Approval Letter
83. / Indoco Remedies Ltd / 2384, 3901, 8105 / Approval Letter
84. / Indoco Remedies Ltd / 2381, 4028, 9829, 14921 / Approval Letter
85. / Intas Pharmaceuticals Ltd / 3154, 5220, 6900, 10561 / Approval Letter
86. / Inventia Healthcare Pvt Ltd / 3533, 5630, 66338, 10401 / Approval Letter
87. / Inventia Healthcare Pvt. Ltd / 6180, 9794 / Approval Letter
88. / Ipca Laboratories Limited / 7038, 10959 / Approval Letter
89. / Ipca Laboratories Ltd / 7028, 11017 / Approval Letter
90. / Ipca Laboratories Ltd / 7032, 11014 / Approval Letter
91. / Johnson and Johnson Ltd / 7132, 10983 / Approval Letter
92. / Jubilant Life Sciences Ltd / 6162, 9792 / Approval Letter
93. / Leiutis Pharmaceuticals Pvt Ltd / 2467, 4197, 6995 / Approval Letter
94. / Leiutis Pharmaceuticals Pvt Ltd / 2471, 4202, 6995 / Approval Letter
95. / Leiutis Pharmaceuticals Pvt Ltd / 2470, 4201, 6995 / Approval Letter
96. / Leiutis Pharmaceuticals Pvt Ltd / 2474, 4203, 6995 / Approval Letter
97. / Leiutis Pharmaceuticals Pvt Ltd / 2469, 4200, 6995 / Approval Letter
98. / Leiutis Pharmaceuticals Pvt Ltd / 2468, 4199, 69994, 1103 / Approval Letter
99. / Lupin Ltd / 6231, 9807 / Approval Letter
100. / Lupin Ltd / 6233, 9806 / Approval Letter
101. / Lupin Ltd / 6232, / Approval Letter
102. / Lupin Ltd / 6230, 9804 / Approval Letter
103. / Lupin Ltd / 62937, 86254, 4837, 7523 / Approval Letter
104. / Lupin Ltd / 4275, 6735, 7638, 11772 / Approval Letter
105. / Lupin Ltd / 4276, 6732, 7263, 11095 / Approval Letter
106. / Mylan Laboratories Ltd / 6217, 9768 / Approval Letter
107. / Mylan Laboratories Ltd / 6127, 9733 / Approval Letter
108. / Mylan Laboratories Ltd / 6620, 11031 / Approval Letter
109. / Natco Pharma Ltd / 796, 1638, 7272, 11097 / Approval Letter
110. / Natco Pharma Ltd / 1239, 2532, 7271, 11101 / Approval Letter
111. / Novartis Healthcare Pvt Ltd / 7092, 10942 / Approval Letter
112. / Novartis Healthcare Pvt Ltd / 7093, 10940 / Approval Letter
113. / Novartis Healthcare Pvt Ltd / 7094, 10939 / Approval Letter
114. / Novartis Healthcare Pvt Ltd / 7095, 10936 / Approval Letter
115. / Novartis Healthcare Pvt Ltd / 7096, 10934 / Approval Letter
116. / Novartis Healthcare Pvt Ltd / 7097, 10931 / Approval Letter
117. / Novartis Healthcare Pvt Ltd / 7098, 10950 / Approval Letter
118. / Novartis India Ltd / 7103, 10952 / Approval Letter
119. / Par Formulations Pvt Ltd / 6643, 11078 / Approval Letter
120. / Par Formulations Pvt Ltd / 6642, 11082 / Approval Letter
121. / Perrigo Laboratories India Pvt Ltd / 7138, 10972 / Approval Letter
122. / Perrigo Laboratories India Pvt Ltd / 7140, 10967 / Approval Letter
123. / Perrigo Laboratories India Pvt Ltd / 7139, 10969 / Approval Letter
124. / PharmaZell(Vizag) Pvt Ltd / 6194, 1448 / Approval Letter
125. / PharmaZell(Vizag) Pvt Ltd / 6195, 9795 / Approval Letter
126. / RA ChemPharma Ltd / 6128, 9763 / Approval Letter
127. / Raptim Research Ltd / 63023, 86214, 4951, 7855 / Approval Letter
128. / Roche Products (India) Pvt. Ltd / 7051, 10631 / Approval Letter
129. / Roche Products (India) Pvt. Ltd / 7150, 10695 / Approval Letter
130. / RPG Life Sciences Ltd / 2033, 3431, 7134, 10980 / Approval Letter
131. / RPG Life Sciences Ltd / 2031, 3434, 7133, 10981 / Approval Letter
132. / Sai Life Sciences Ltd / 6912, 10977 / Approval Letter
133. / Sai Life Sciences Ltd / 6893, 10995 / Approval Letter
134. / Sai Life Sciences Ltd / 6895, 10993 / Approval Letter
135. / Sai Life Sciences Ltd / 6894, 10997 / Approval Letter
136. / Sai Life Sciences Ltd / 6911, 11007 / Approval Letter
137. / Sai Life Sciences Ltd / 6961, 11009 / Approval Letter
138. / Sai Life Sciences Ltd / 6962, 11008 / Approval Letter
139. / Sanmour Pharma Pvt Ltd / 64093, 87878, 6446, 9923 / Approval Letter
140. / Sanofi-Synthelabo (India) Ltd / 6939, 11010 / Approval Letter
141. / Shasun Pharmaceuticals Ltd / 6552, 10523 / Approval Letter
142. / Shasun Pharmaceuticals Ltd / 6551, 10524 / Approval Letter
143. / Shasun Pharmaceuticals Ltd / 6550, 10525 / Approval Letter
144. / Sun Pharmaceutical Industries Ltd / 7042, 10718 / Approval Letter
145. / Sun Pharmaceutical Industries Ltd / 7041, 10730 / Approval Letter
146. / Teva API India Ltd / 349, 937, 6276, 9606 / Approval Letter
147. / Teva PAI India Ltd / 348, 933, 6275, 9654 / Approval Letter
148. / Tevapharm India Pvt Ltd / 6795, 10371 / Approval Letter
149. / Torrent Pharmaceuticals Ltd / 6119, 9811 / Approval Letter
150. / Torrent Pharmaceuticals Ltd / 6120, 9722 / Approval Letter
151. / United States Pharmacopeia-India Pvt Ltd / 64780, 88677, 6219, 9803 / Approval Letter
152. / United States Pharmacopeia-India Pvt Ltd / 6625, 11045 / Approval Letter
153. / United States Pharmacopeia-India Pvt Ltd / 6624, 11040 / Approval Letter
154. / Vimta Labs / 3470, 5793, 8383, 12898 / Approval Letter
155. / Vimta Labs / 3471, 5789, 8383, 12898 / Approval Letter
156. / Vimta Labs / 3472, 5774, 8383, 12898 / Approval Letter
157. / Vimta Labs / 3473, 5768, 8383, 12898 / Approval Letter
158. / Vimta Labs / 3474, 5766, 8383, 12898 / Approval Letter
159. / Vimta Labs / 3475, 5762, 8383, 12898 / Approval Letter
160. / Vimta Labs / 3476, 5759, 8383, 12898 / Approval Letter
161. / Vimta Labs / 3477, 5752, 8383, 12898 / Approval Letter
162. / Vimta Labs / 3478, 5750, 8383, 12898 / Approval Letter
163. / Vimta Labs / 3479, 5747, 8383, 12898 / Approval Letter
164. / Vivimed Labs (Alathur) Pvt Ltd / 5626, 8628 / Approval Letter
165. / Wockhardt Ltd / 6992, 11006 / Approval Letter
166. / Wockhardt Ltd / 6993, 11004 / Approval Letter
167. / Wockhardt Ltd / 4090, 6529, 8456, 12835 / Approval Letter
EXPORT NOC
S. No / Firm Name / D. No / Type of Letter1. / M/s.Embio Limited., / 9246 / Approval Letter
2. / M/s. Sandoz Private Ltd., / 3058 / Approval Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Gangwal Chemicals Pvt. Ltd. / 5242 / CLARIFICATION LETTER
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Johnson & Johnson Ltd. / 51919 / Query Letter
2. / M/s. Meril Endo Surgery Pvt. Ltd. / 52729 / Query Letter
3. / M/s. Manju Enterprises Pvt. Ltd. / FTS-81519 / Query Letter
4. / M/s. Max Neeman Medical International Ltd. / 3984 / Query Letter
5. / M/s. St. Jude Medical India Pvt. Ltd. / 52660 / Query Letter
6. / M/s. Emergo (India) Consulting Pvt. Ltd. / 3662 / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Apex Diagnostics. / 3375 / Query Letter
2. / M/s. Allied Biotechnology India (P) Ltd. / 7282 / Query Letter
3. / M/s. Bio Rad Laboratories (India) Pvt. Ltd. / 7261 / Query Letter
4. / M/s. Becton Dickinson India Pvt. Ltd. / 7603 / Query Letter
5. / M/s. U. R. Biomedical Pvt. Ltd. / 4822 / Query Letter
6. / M/s. Vedas Healthcare. / 5500 / Query Letter
7. / M/s. Vishat Diagnostics Pvt. Ltd. / 6856 / Query Letter
8. / M/s. Achira Labs Pvt. Ltd. / FTS-7733 / Query Letter
9. / M/s. Biocell Medicare. / FTS-12753 / Query Letter
10. / M/s. Biotron Healthcare (India) Pvt. Ltd. / 5348 / Query Letter
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Globion India Pvt Ltd / Clarification letter
2 / M/s Manipal Acunova Ltd / 3002 / Clarification letter
3 / M/s RA chem Pharma Ltd / 1184 / Approval letter
4 / M/s Brilliant Biopharma Ltd / 7424 / Approval letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Wockhardt Ltd., / NIl / Clarification Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Neon Lab Ltd. / 63955 / 87813 / Deficiency Letter
2. / M/s Sun Pharmaceutical / 60851 / 84097 / Deficiency Letter
NEW DRUG