LETTERS FOR ISSUE ON 24.09.2014
BA/BE DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. ICBio Clinical Research, Bangalore / 54043 / Query
02 / M/s. Veeda Clinical Research, Gujarat / 29240 / Approval
03 / M/s. Manipal Accunova, Mangalore / Query
04 / M/s. Accutest research Laboratories, Gujarat / 14794 / Query
05 / M/s. Auriga Research Ltd., New Delhi / 57731 / Approval
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Synergy Diagnostics Pvt, ltd / 39090 / Approval Letter
2 / M/s Indovax pvt, ltd / 51912 (fts no) / Clarification Letter
3 / M/s Panacea Biotech Ltd / 79341 (fts no) / Approval Letter
4 / M/s BCG Vaccine Laboratory / 48033 (fts no) / Clarification Letter
5 / M/s Novo Nordisk India Pvt, ltd / 13242 / Approval Letter
6 / M/s Serum Institute of India Ltd / 31674 / Clarification Letter
7 / M/s Cadila Pharmaceuticals Ltd / Continuation letter
8 / M/s Human Biologicals Institute / Clarification Letter
9 / M/s Virbac Animal Health India Pvt, ltd / 34420 / Approval Letter
10
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 / 37886 / Approval Letter
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 37874 / Approval Letter
3. / M/s. Alkem Laboratories Ltd., Taloja-410 208, Tal: Panvel, Dist: Raigad / 37959 / Approval Letter
4. / M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 25565 / Approval Letter
5. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 38036 / Approval Letter
6. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 37899 / Approval Letter
7. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 37933 / Approval Letter
8. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 37934 / Approval Letter
9. / M/s. Clinigene International Ltd., Bangalore-560 100 / 37793 / Approval Letter
10. / M/s. Kusum Healthcare Pvt. Ltd., New Delhi-110 020 / 30722 / Approval Letter
11. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 38280 / Approval Letter
12. / M/s. Lupin Bioresearch Center, Pune-411 021 / 27212 / Amendment Letter
13. / M/s. Lupin Bioresearch Center, Pune-411 021 / 38330 / Approval Letter
14. / M/s. Lupin Bioresearch Center, Pune-411 021 / 17179 / Approval Letter
15. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 36647 / Rejection Letter
16. / M/s. Sun Pharmaceutical Industries Ltd., Vadodara-390 020 / 24906 / Approval Letter
17. / M/s. Synapse Labs Pvt. Ltd., Kharadi, Pune-411 014 / 39248 / Approval Letter
18. / M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 36241 / Approval Letter
ONLY TEST LICENCE FOR BE
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 38035 / Test Licecne
2. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 38034 / Test Licecne
3. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 37725 / Test Licecne
4. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 37726 / Test Licecne
5. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 37724 / Test Licecne
6. / M/s. Semler Research Center, Bangalore-560078 / 38266 / Test Licecne
7. / M/s. Sitec Labs Pvt Ltd, Navi Mumbai-400701 / 38561 / Test Licecne
8. / M/s. Torrent Pharmaceuticals Ltd. (Research Centre), Gujarat / 38240 / Test Licecne
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Progen SAS Technologies India (P) Ltd. / 29781 / Letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s Sun Pharmaceutical Industries Ltd., / 45445 / 61751 / Deficiency Letter
2. / M/s RPG Life Sciences Ltd., / 29396 / 43581 / Deficiency Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Agila Specialties Pvt. Ltd / 37786, 55777 / Approval Letter
2. / Aizant Drug Research Solutions Pvt. Ltd / 37366, 55141 / Approval Letter
3. / Alembic Pharmaceuticals Ltd / 37425, 55145 / Approval Letter
4. / Alkem Laboratories Ltd / 37556, 55260 / Approval Letter
5. / Alkem Laboratories Ltd / 37569, 55246 / Approval Letter
6. / Amneal Pharmaceuticals Company (I) Pvt. Ltd / 37416, 55196 / Approval Letter
7. / Amneal Pharmaceuticals Company (I) Pvt. Ltd / 37415, 55199 / Approval Letter
8. / Bharat Serums and Vaccines Ltd / 37631, 55548 / Approval Letter
9. / Bharat Serums and Vaccines Ltd / 37630, 55553 / Approval Letter
10. / Cadila Healthcare Ltd / 37580, 55250 / Approval Letter
11. / Cadila Healthcare Ltd / 37729, 55518 / Approval Letter
12. / Cadila Healthcare Ltd / 37730, 55516 / Approval Letter
13. / Cadila Pharmaceuticals Limited / 37282, 55200 / Approval Letter
14. / Claris Life Sciences Ltd / 37314, 55139 / Approval Letter
15. / Claris Life Sciences Ltd / 37315, 55133 / Approval Letter
16. / Claris Life Sciences Ltd / 37316, 55040 / Approval Letter
17. / Claris Life Sciences Ltd / 37317, 55037 / Approval Letter
18. / Claris Life Sciences Ltd / 37322, 55054 / Approval Letter
19. / Claris Life Sciences Ltd / 37323, 55051 / Approval Letter
20. / Claris Life Sciences Ltd / 37324, 55048 / Approval Letter
21. / Claris Life Sciences Ltd / 37325, 55045 / Approval Letter
22. / Dr. Reddy’s Laboratories Ltd / 37396, 55185 / Approval Letter
23. / Dr. Reddy’s Laboratories Ltd / 37402, 55188 / Approval Letter
24. / Dr. Reddy’s Laboratories Ltd / 37397, 55137 / Approval Letter
25. / Dr. Reddy’s Laboratories Ltd / 37398, 55134 / Approval Letter
26. / Dr. Reddy’s Laboratories Ltd / 37399, 55129 / Approval Letter
27. / Dr. Reddy’s Laboratories Ltd / 37400, 10060 / Approval Letter
28. / Dr. Reddy’s Laboratories Ltd / 37401, 55119 / Approval Letter
29. / Emcure Pharmaceuticals Ltd / 37417, 55192 / Approval Letter
30. / Emcure Pharmaceuticals Ltd / 37769, 55795 / Approval Letter
31. / Emcure Pharmaceuticals Ltd / 37770,55794 / Approval Letter
32. / Encube Ethicals Pvt. Ltd / 37283, 55155 / Approval Letter
33. / FTF Pharma Pvt Ltd / 37728, 55526 / Approval Letter
34. / FTF Pharma Pvt. Ltd / 37879, 55771 / Approval Letter
35. / Getz Pharma Research Pvt Ltd / 37629, 55418 / Approval Letter
36. / Glenmark Generics Ltd / 37529, 55510 / Approval Letter
37. / Glenmark Generics Ltd / 37530, 55505 / Approval Letter
38. / Glenmark Generics Ltd / 37531, 55502 / Approval Letter
39. / Glenmark Generics Ltd / 37532, 55497 / Approval Letter
40. / Glenmark Generics Ltd / 37528, 55433 / Approval Letter
41. / Glenmark Generics Ltd / 37533, 55494 / Approval Letter
42. / Glenmark Generics Ltd / 37527, 55436 / Approval Letter
43. / Hospira Healthcare India Pvt. Ltd / 37783, 55803 / Approval Letter
44. / Hospira Healthcare India Pvt. Ltd / 37784, 55806 / Approval Letter
45. / Indoco Remedies Ltd / 37299, 55162 / Approval Letter
46. / Indoco Remedies Ltd / 37300, 55126 / Approval Letter
47. / Indoco Remedies Ltd / 37301, 55112 / Approval Letter
48. / Indoco Remedies Ltd / 37302, 55078 / Approval Letter
49. / Indoco Remedies Ltd / 37318, 55073 / Approval Letter
50. / Indoco Remedies Ltd / 37319, 55070 / Approval Letter
51. / Indoco Remedies Ltd / 37320, 55065 / Approval Letter
52. / Indoco Remedies Ltd / 37321, 55061 / Approval Letter
53. / Intas Pharmaceuticals Ltd / 37456, 55223 / Approval Letter
54. / Intas Pharmaceuticals Ltd / 37457, 55225 / Approval Letter
55. / Intas Pharmaceuticals Ltd / 37458, 55229 / Approval Letter
56. / Intas Pharmaceuticals Ltd / 37459, 55231 / Approval Letter
57. / Intas Pharmaceuticals Ltd / 37460, 55237 / Approval Letter
58. / Ipca Laboratories Limited / 37846,55780 / Approval Letter
59. / Ipca Laboratories Limited / 37847, 55778 / Approval Letter
60. / Ipca Laboratories Limited / 37848, 55775 / Approval Letter
61. / Ipca Laboratories Limited / 37849, 55773 / Approval Letter
62. / Ipca Laboratories Ltd / 37666, 55529 / Approval Letter
63. / Ipca Laboratories Ltd / 37665, 55532 / Approval Letter
64. / Ipca Laboratories Ltd / 37667, 55538 / Approval Letter
65. / Ipca Laboratories Ltd / 37664, 55546 / Approval Letter
66. / Johnson and Johnson Ltd / 37850, 55770 / Approval Letter
67. / Jubilant Generics Ltd / 37284, 55167 / Approval Letter
68. / Jubilant Generics Ltd / 37298, 55169 / Approval Letter
69. / Lupin Ltd / 37414, 55201 / Approval Letter
70. / Lupin Ltd / 37413, 55202 / Approval Letter
71. / Lupin Ltd / 37412, 55204 / Approval Letter
72. / Lupin Ltd / 37411, 55206 / Approval Letter
73. / Lupin Ltd / 37824, 55779 / Approval Letter
74. / Manipal AcuNova Ltd / 37466, 55276 / Approval Letter
75. / Mylan Laboratories Ltd / 37478, 55253 / Approval Letter
76. / Mylan Laboratories Ltd / 37733, 55424 / Approval Letter
77. / Novartis Healthcare Pvt Ltd / 37872, 55788 / Approval Letter
78. / Novartis Healthcare Pvt Ltd / 37873, 55785 / Approval Letter
79. / Novartis Healthcare Pvt Ltd / 37880, 55810 / Approval Letter
80. / Novartis Healthcare Pvt Ltd / 37881,55807 / Approval Letter
81. / Novartis Healthcare Pvt Ltd / 37907, 55802 / Approval Letter
82. / Onco Therapies Ltd / 37559, 55452 / Approval Letter
83. / Onco Therapies Ltd / 37558, 55455 / Approval Letter
84. / Par Formulations Pvt Ltd / 37639, 55451 / Approval Letter
85. / Par Formulations Pvt Ltd / 37638, 55447 / Approval Letter
86. / Ranbaxy Laboratories Ltd / 37787, 55774 / Approval Letter
87. / Strides Arcolab Ltd / 37557, 55460 / Approval Letter
88. / Sun Pharma Advanced Research Company Ltd / 37663, 55583 / Approval Letter
89. / Sun Pharmaceutical Industries Ltd / 37505, 55263 / Approval Letter
90. / Sun Pharmaceutical Industries Ltd / 37662, 55586 / Approval Letter
91. / Sun Pharmaceutical Industries Ltd / 37672, 55589 / Approval Letter
92. / Sun Pharmaceutical Industries Ltd / 37668, 55570 / Approval Letter
93. / Sun Pharmaceutical Industries Ltd / 37670, 55567 / Approval Letter
94. / Sun Pharmaceutical Industries Ltd / 37673, 55558 / Approval Letter
95. / Sun Pharmaceutical Industries Ltd / 37671, 55562 / Approval Letter
96. / Sun Pharmaceutical Industries Ltd / 37669, 55574 / Approval Letter
97. / Supriya Life Sciences Ltd / 37477, 55268 / Approval Letter
98. / Symbiotec Pharmalab Ltd / 37383, 55093 / Approval Letter
99. / Torrent Pharmaceuticals Ltd / 37432, 55194 / Approval Letter
100. / Torrent Pharmaceuticals Ltd / 37827, 55793 / Approval Letter
101. / Torrent Pharmaceuticals Ltd / 37828, 55799 / Approval Letter
102. / Torrent Pharmaceuticals Ltd / 37829, 55797 / Approval Letter
103. / USV Ltd / 37627, 55440 / Approval Letter
104. / USV Ltd / 37628, 55439 / Approval Letter
105. / VerGo Pharma Research laboratories Pvt Ltd / 37598, 55442 / Approval Letter
106. / VerGo Pharma Research Laboratories Pvt Ltd / 37597, 55446 / Approval Letter
107. / Vimta Labs Ltd / 37480, 55484 / Approval Letter
108. / Vimta Labs Ltd / 37482, 55473 / Approval Letter
109. / Vimta Labs Ltd / 37479, 55486 / Approval Letter
110. / Vimta Labs Ltd / 37481, 55478 / Approval Letter
111. / Vimta Labs Ltd / 37483, 55468 / Approval Letter
112. / Vimta Labs Ltd / 37484, 55465 / Approval Letter
113. / Watson Pharma Pvt Ltd / 37367, 55083 / Approval Letter
114. / Watson Pharma Pvt Ltd / 37368, 55082 / Approval Letter
115. / Watson Pharma Pvt Ltd / 37369, 55117 / Approval Letter
116. / Watson Pharma Pvt Ltd / 37370, 55114 / Approval Letter
117. / Watson Pharma Pvt Ltd / 37371, 55109 / Approval Letter
118. / Watson Pharma Pvt Ltd / 37372, 55107 / Approval Letter
119. / Watson Pharma Pvt Ltd / 37373, 55104 / Approval Letter
120. / Watson Pharma Pvt Ltd / 37374, 55103 / Approval Letter
121. / Watson Pharma Pvt Ltd / 37375, 55099 / Approval Letter
122. / Watson Pharma Pvt Ltd / 37376, 55097 / Approval Letter
123. / Watson Pharma Pvt Ltd / 37377, 55094 / Approval Letter
124. / Watson Pharma Pvt Ltd / 37378, 55091 / Approval Letter
125. / Watson Pharma Pvt Ltd / 37379, 55088 / Approval Letter
126. / Watson Pharma Pvt Ltd / 37380, 55086 / Approval Letter
127. / Watson Pharma Pvt Ltd / 37381, 55170 / Approval Letter
128. / Windlas Healthcare (P) Ltd / 37731, 55422 / Approval Letter
129. / Wintac Limited / 37433, 55209 / Approval Letter
130. / Wintac Limited / 37434, 55207 / Approval Letter
131. / Zoetis Pharmaceutical Research Pvt. Ltd / 37815, 55766 / Approval Letter
132. / Zoetis Pharmaceutical Research Pvt. Ltd / 37816, 55763 / Approval Letter
133. / Zoetis Pharmaceutical Research Pvt. Ltd / 37817, 55762 / Approval Letter
134. / Albert David Ltd / 39089, 57475 / Amendment Letter
135. / Alkem Laboratories Ltd / 39973, 58946 / Amendment Letter
136. / Indoco Remedies Ltd / 39578, 58124 / Amendment Letter
137. / Indoco Remedies Ltd / 39577, 58127 / Amendment Letter
138. / Resonance Laboratories Pvt Ltd / 56734 / Amendment Letter
139. / Sun Pharmaceutical Industries Ltd / 39512, 58168 / Amendment Letter
140. / Alkem Laboratories Ltd / 39504, 58134 / Endorsement Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Catalyst / 38171 / Clarification Letter
2. / M/s. Kendle / 34070 / Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Cadila Healthcare Ltd. / - / CT NOC Letter(2)
2. / Dr. Manpreet Singh / - / Query Letter
3. / Dr. V Kalaiselvan / - / Query Letter